Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

· Keep this leaflet. You may need to read it again.

· If you have any further questions, ask your doctor or pharmacist.

· This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

· If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What does this leaflet contain?

1. What is BOTOX 50 UNITS ALLERGAN, powder for solution for injection and what is it used for?

2. What you need to know before using BOTOX 50 UNITS ALLERGAN, powder for solution for injection?

3. How to use BOTOX 50 UNITS ALLERGAN, powder for injectable solution?

4. What are the possible side effects?

5. How to store BOTOX 50 UNITS ALLERGAN, powder for injectable solution?

6. Package contents and other information.

1. WHAT IS BOTOX 50 UNITS ALLERGAN, powder for solution for injection AND WHAT IS IT USED FOR?  

Pharmacotherapeutic group – ATC code: M03AX01

BOTOX is a muscle relaxant used to treat a number of conditions in the body. It contains the active substance botulinum toxin type A which is injected into the muscles as well as into the bladder wall or deep into the skin. It works by partially blocking nerve impulses to any muscles that have been injected and reduces excessive contractions of those muscles.

When injected under the skin of the armpits, BOTOX works on the sweat glands to reduce the amount of sweat produced. When injected into the bladder wall, BOTOX works on the bladder muscle to reduce urine leakage (urinary incontinence).

When injected into the muscles of the head and neck, BOTOX blocks pain signals to prevent and treat chronic migraine.

Indications in adults:

Bladder problems:

When injected into the bladder wall, BOTOX works on the bladder muscle to reduce urine leakage (urinary incontinence) and control the following:

· Idiopathic overactive bladder with urinary leakage (3 episodes in three days): sudden urge to urinate and go to the toilet more often than usual (at least 8 or more episodes per day) when treatment with another medicine (called an anticholinergic) has not worked.

· Overactive bladder due to problems associated with spinal cord injury or multiple sclerosis , leading to urinary leakage (involuntary passage of urine during the day or night).

Neurological disorders:

BOTOX is used to prevent chronic migraine in adults who have had headaches for 15 or more days per month, including at least 8 migraine days, and who have not responded well to other migraine preventive medicines.

Chronic migraine is a disease that affects the nervous system. Patients typically experience headaches that are often associated with excessive sensitivity to light, loud sounds or smells, as well as nausea and/or vomiting. These headaches occur at least 15 days per month.

Indications for adults and children over 12 years old:

BOTOX can be injected directly into muscles to control the following conditions:

· persistent muscle spasms in the muscles around the eyes, eyelids and face, causing strabismus or squinting;

· persistent muscle spasms of the eyelids and face;

· persistent muscle spasms in the neck and shoulders.

BOTOX can be injected deep into the skin and act on the sweat glands to reduce excessive underarm sweating; symptoms that can interfere with daily activities when other topical treatments fail to work.

Indication in adults and children aged 2 years and over:

BOTOX can be injected directly into the muscles and thus control persistent muscle spasms in the arms and/or legs.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE BOTOX 50 UNITS ALLERGAN, powder for solution for injection?  

Never use BOTOX 50 UNITS ALLERGAN, powder for injectable solution:

· if you are allergic to botulinum toxin type A or any of the other ingredients of this medicine (listed in section 6),

· if you suffer from myasthenia gravis (a chronic disease affecting your muscles),

· if you have an infection at the injection site,

· in patients with overactive bladder without known cause or associated with spinal cord injury or multiple sclerosis , in case of urinary tract infection at the time of treatment or in case of inability to empty your bladder without being accustomed to using a urinary catheter.

Warnings and precautions

Talk to your doctor before using BOTOX 50 UNITS ALLERGAN, powder for solution for injection:

· if you have ever had problems swallowing or if food or any liquid has ever accidentally passed into your lungs , particularly if you are being treated for persistent muscle spasms in the neck and shoulders;

· if you are over 65 years old and have other serious illnesses ;

· if you have any other muscle problems or chronic diseases affecting your muscles (such as myasthenia gravis or Lambert-Eaton syndrome);

· if you suffer from certain diseases affecting the nervous system (such as amyotrophic lateral sclerosis (Charcot’s disease) or motor neuropathy);

· if you have significant weakness or muscle wasting in the muscles your doctor plans to inject;

· if you have ever had surgery or had an injury that may have changed in any way the muscle that is to receive the injection;

· if you have ever experienced any disturbances during previous injections (such as fainting);

· if you have inflammation of the muscles or skin area where your doctor plans to inject;

· if you suffer from cardiovascular disease (heart or blood vessel disease);

· if you suffer or have suffered from convulsions;

· if you have an eye condition called narrow-angle glaucoma (high pressure in the eye) or have been told there is a risk that you may develop this type of glaucoma;

· if you are going to be treated for overactive bladder with urinary leakage and you are a man with signs and symptoms of urinary retention or obstruction, such as difficulty urinating or a weak or interrupted stream.

After receiving an injection of BOTOX 50 UNITS ALLERGAN, powder for injectable solution

You or anyone helping you should contact your doctor for immediate medical assistance if you experience any of the following:

· difficulty breathing, swallowing or speaking;

· hives, swelling including swelling of the face or throat, wheezing, dizziness and shortness of breath (possible symptoms of a severe allergic reaction).

General precautions

· This product is reserved for hospital use due to its characteristics: you cannot hold it. The preparation of the product must be carried out by experienced personnel, in a suitable room.

· The injection must be performed by a physician with good training and experience in the use of botulinum toxin in the indications provided for in the marketing authorization.

· As with any injection, the procedure may cause infection, pain, swelling, burning and stinging, increased sensitivity, tenderness, redness and/or bleeding/bruising at the injection site.

· Adverse reactions related to the spread of the toxin away from the injection site have been reported (e.g. muscle weakness, difficulty swallowing, choking of food or liquid into the airways) with consequences that may be serious or even fatal in very rare cases. The risk of such reactions is greater in patients with neurological disease with difficulty swallowing.

If you receive BOTOX injections too frequently or if the dose injected is too high, you may experience muscle weakness and side effects related to the spread of the toxin or your body may produce antibodies, which may reduce the effect of BOTOX. To limit this risk, a minimum time interval must be respected between 2 injection sessions (see section 3. How to use BOTOX 50 UNITS ALLERGAN, powder for solution for injection?).

· When BOTOX is used to treat a condition not listed in this leaflet, it could cause serious reactions, particularly in patients who already have difficulty swallowing or who experience extreme general weakness.

· If you have not had regular physical activity for a long time before receiving BOTOX treatment, then you will need to gradually begin any activity after the injections.

· This medicine is unlikely to improve the range of motion of joints where the surrounding muscle has lost elasticity.

· When BOTOX is used to treat persistent eyelid muscle spasms, decreased blinking may occur, which can damage the surface of your eyes. To prevent this, you will need treatment with eye drops, ointments, soft contact lenses, or even a shield that covers and holds the eye closed. Your doctor will advise you if this is necessary.

· In case of treatment of idiopathic overactive bladder:

o You must be able to use sterile urinary catheters to empty your bladder.

o You will be seen by your doctor 2 weeks after the injection. You will need to urinate and the volume of urine remaining in your bladder will be measured by ultrasound. Your doctor will then decide whether you need to return for a repeat of this test within the next 12 weeks. You should contact your doctor if you are unable to urinate.

o An interruption of treatment with antiplatelet agents (such as aspirin) and/or anticoagulants (blood thinners) is recommended 3 days before the injection procedure.

· In case of treatment of detrusor overactivity associated with spinal cord injury or multiple sclerosis:

o You or someone you know must be able to use sterile urinary catheters to empty your bladder.

o You will be seen by your doctor 2 weeks after the injection, if you had spontaneous urination or partial spontaneous urination before the injection. You will need to urinate and the volume of urine remaining in your bladder will be measured by ultrasound. Your doctor will then decide whether you need to return for a repeat of this test within the next 12 weeks. You should contact your doctor if you are unable to urinate.

An interruption of treatment with antiplatelet agents (such as aspirin) and/or anticoagulants (blood thinners) is recommended 3 days before the injection procedure.

Children and adolescents

Not applicable.

Other medicines and BOTOX 50 UNITS ALLERGAN, powder for solution for injection

Tell your doctor if:

· you are taking antibiotics (used to treat infections), anticholinesterases or muscle relaxants. Some of these medicines may increase the effect of BOTOX,

· you have recently been injected with a medicine containing botulinum toxin (the active substance in BOTOX) as the effect of BOTOX may be significantly increased,

· you are taking antiplatelet drugs (such as aspirin) and/or anticoagulants (blood thinners).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

BOTOX 50 UNITS ALLERGAN, powder for solution for injection with food, drink and alcohol

Not applicable.

Pregnancy and breastfeeding

BOTOX is not recommended for use during pregnancy and in women of childbearing potential not taking contraception, unless clearly necessary. BOTOX is not recommended for use in women who are breastfeeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving vehicles and using machines

Attention is drawn, particularly to drivers of vehicles and users of machines, to the risks of dizziness, drowsiness, fatigue, muscular weakness or vision problems linked to the use of this medicine, which may make driving vehicles or using machines dangerous.

BOTOX contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free’.

3. HOW TO USE BOTOX 50 UNITS ALLERGAN, powder for solution for injection?  

Warning

The preparation and injection of BOTOX should be performed by experienced healthcare personnel only (see section 2. Take special precautions with BOTOX 50 UNITS ALLERGAN, powder for solution for injection).

Dosage

Dosage varies depending on the indication and age. Your doctor will determine the right dose for you, as described in the Dosage section of the Summary of Product Characteristics.

As a guide, the dosage may vary from 17.5 ALLERGAN UNITS per injection to a maximum dose of 360 ALLERGAN UNITS per injection session in certain indications.

Mode of administration

Injection into the muscles (intramuscular route), into the bladder wall using a specific instrument (cystoscope) or under the skin (intradermal route) depending on the indication. BOTOX is injected directly into the area to be treated. Your doctor will usually inject BOTOX into several sites in each treated area.

The preparation of the product must be carried out in a suitable room and by experienced personnel in order to minimise the risk of accidents during handling.

Reconstitution of BOTOX, powder for solution for injection is carried out using 0.9 percent sodium chloride injection solution.

General dosage information

The number of injections per muscle and the dose vary depending on the indications. Therefore, your doctor will decide the amount, frequency and in which muscle(s) BOTOX will be injected. It is recommended that your doctor use the minimum effective dose.

The dosage and duration of action of BOTOX vary depending on the condition you are being treated for. Below are the details for each condition.

The safety and efficacy of BOTOX have been established in children and adolescents aged over two years in the local symptomatic treatment of spasticity .

Limited information is available on the use of BOTOX in children and adolescents at the ages listed in the table below in the following indications.

No dosage recommendations can be made for these indications.

Dosage

* Depending on the dose chosen by the doctor, the interval between 2 injection sessions can be up to 6 months.

**If you use sterile urinary catheters to empty your bladder.

The interval should be adapted to the patient’s health status and will depend on the reappearance of symptoms.

Time to improvement and treatment duration

Always follow the medical prescription.

Persistent muscle spasms of the arms and/or legs in children 2 years of age and older: improvement usually occurs within the first 2 weeks after injection.

Persistent muscle spasms of the arms and/or legs in adults: improvement usually occurs within the first 2 weeks after injection. The maximum effect is usually observed approximately 4 to 6 weeks after injection.

Persistent muscle spasms in the muscles around the eyes, eyelids and face, causing strabismus or squinting : improvement usually occurs within 2 days after injection. Usually, the effect lasts 2 to 6 weeks after injection.

Persistent muscle spasms of the eyelids and face: improvement usually appears within the first 3 days after injection. Maximum effect is usually observed after 1 to 2 weeks.

Persistent muscle spasms of the neck and shoulders: improvement usually appears within 2 weeks after injection. Maximum effect is usually observed about 6 weeks after injection.

Idiopathic overactive bladder with urinary leakage: improvement usually appears within 2 weeks after injection. Usually, the effect lasts approximately 6-7 months after injection.

Overactive bladder associated with spinal cord injury or multiple sclerosis in adults: improvement usually occurs within 2 weeks after injection. Usually, the effect lasts approximately 8-9 months after injection.

Excessive underarm sweating: improvement usually appears within the first week after injection. The effect usually lasts more than 4 months and can persist for a year or more.

Chronic migraine: improvement usually appears within 3 weeks after injection. Usually, the effect lasts 3 months after injection .

If you receive more BOTOX 50 UNITS ALLERGAN, powder for solution for injection than you should:

Consult your doctor or pharmacist immediately.

Signs of an overdose of BOTOX may not appear for several days after injection. If you swallow BOTOX or are accidentally injected, you should see your doctor who may keep you under observation for several weeks.

If you have received an excessive dose of BOTOX, one of the following symptoms may occur. You should contact your doctor immediately who will decide whether you need to go to the hospital:

· muscle weakness local or distant from the injection site;

· difficulty breathing, swallowing or speaking due to muscle paralysis;

· pneumonia (lung infection) due to paralysis of the muscles, caused by accidental ingestion of food or liquid into the lungs;

· drooping eyelids, double vision;

· generalized weakness.

If you forget to use BOTOX 50 UNITS ALLERGAN, powder for solution for injection

Not applicable.

If you stop using BOTOX 50 UNITS ALLERGAN, powder for solution for injection

Not applicable.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?  

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Usually, side effects appear within the first few days after the injection. Usually they last only for a short time, but they can last for several months and in rare cases, longer.

If you have difficulty breathing, swallowing, or speaking after receiving a BOTOX injection, CONTACT YOUR DOCTOR IMMEDIATELY.

If you develop hives, swelling including swelling of the face or throat, wheezing, dizziness, and shortness of breath, CONTACT YOUR DOCTOR IMMEDIATELY.

Adverse reactions independent of the injection site or indication

· Adverse effects related to the spread of the toxin away from the injection site have been reported very rarely: excessive muscle weakness, difficulty swallowing, pneumonia due to food or liquid getting into the airways, which can be fatal in some cases.

· Rare general allergic reactions (rash, erythema, pruritus, anaphylactic reaction).

· Pain/burning at the injection site, possible regardless of the injection site or indication.

Side effects are classified into the following categories, depending on their frequency:

The following lists of side effects vary depending on the part of the body where BOTOX is injected. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, contact your doctor or pharmacist.

Treatment of persistent muscle spasms of the eyelid and face

Treatment of persistent muscle spasms of the neck and shoulders

Very common	Difficulty swallowing, muscle weakness, pain
Frequent	Swelling and irritation inside the nose (rhinitis), blocked or runny nose, cough, sore throat, tickling or irritation in the throat, dizziness, increased muscle tension (cramps), reduced skin sensitivity, drowsiness, headache, dry mouth, nausea, stiff or sore muscles, tiredness, flu-like symptoms, feeling unwell
Uncommon	Double vision, fever, drooping eyelid, shortness of breath, change in your voice

Treatment of excessive underarm sweating

Treatment of persistent muscle spasms of the arms and/or legs in adults

Treatment of persistent muscle spasms of the arms and/or legs in children 2 years of age and older

In children, the following side effects have been observed during treatment of persistent muscle spasms of the arms:

In children, the following side effects have been observed during treatment of persistent leg muscle spasms:

Treatment of idiopathic overactive bladder with urinary leakage

* This side effect may be related to the injection procedure

** This side effect is related to the injection procedure

Treatment of overactive bladder with urinary leakage in children

*This side effect is only related to the injection procedure

Treatment of overactive bladder in adults associated with spinal cord injury or multiple sclerosis leading to urinary leakage

* Some of these common side effects may be related to the injection procedure

Treatment of overactive bladder in children associated with spina bifida, spinal cord injury or transverse myelitis leading to urinary leakage.

Injections into the muscles of the head and neck for the treatment of headaches in patients with chronic migraine

Chronic migraine

Undetermined frequency: Mephisto effect (raising of the outer part of the eyebrows)

Since its marketing , additional adverse effects have been reported with BOTOX, common to all situations:

· Allergic reactions including reactions to injected proteins or serums;

· Swelling of the deep layers of the skin;

· Urticaria;

· Eating disorders, loss of appetite;

· Nerve damage (brachialgia);

· Voice and speech disorders;

· Sagging of muscles on one side of the face;

· Weakness of facial muscles;

· Reduced skin sensitivity;

· Muscle weakness;

· Chronic disease affecting the muscles (myasthenia gravis);

· Difficulty moving the arm and shoulder;

· Numbness;

· Pain/numbness/weakness, starting from the spine;

· Convulsions and fainting;

· Increased eye pressure;

· Strabismus;

· Blurred vision;

· Difficulty seeing clearly;

· Decreased hearing;

· Impression of noises in the ear;

· Feeling dizzy or “spinning” (vertigo);

· Heart problems including heart attack;

· Inhalation pneumonia (inflammation of the lungs caused by accidentally inhaling food, drink, saliva, or vomit);

· Respiratory disorders, respiratory depression and/or respiratory failure;

· Abdominal pain;

· Diarrhea, constipation;

· Dry mouth;

· Difficulty swallowing;

· Nausea, vomiting;

· Hair loss;

· Itching;

· Different types of red patchy skin rashes;

· Excessive sweating;

· Loss of eyelashes/eyebrows;

· Muscle pain, loss of innervation and atrophy of the injected muscle;

· Feeling of general malaise;

· Fever ;

· Dry eye;

· Localized muscle contractions / involuntary muscle contractions ;

· Swelling of the eyelid.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers – Website: https://signalement.social-sante.gouv.fr/ .

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE BOTOX 50 UNITS ALLERGAN, powder for solution for injection?  

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle after EXP. The expiry date refers to the last day of that month.

Store at a temperature between +2°C and +8°C (in the refrigerator).

After reconstitution in its vial, immediate use of the solution is recommended, although stability has been demonstrated for 24 hours between +2°C and +8°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. Buy Botox Cosmetic 50 Units

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION  

What BOTOX 50 UNITS ALLERGAN, powder for solution for injection contains  

· The active substance is:

Botulinum toxin type A* ¹ ………………………………………………………… 50 units* ² ALLERGAN

for a bottle.

* ¹ (from Clostridium botulinum)

* ² One unit corresponds to the lethal dose 50 (LD50) of the reconstituted product injected intraperitoneally in mice.

· The other ingredients are: human albumin, sodium chloride.

What BOTOX 50 UNITS ALLERGAN, powder for solution for injection looks like and contents of the pack  

This medicine is presented as a fine white powder for solution for injection which may be difficult to see in the bottom of the vial (in vial of 50 ALLERGAN UNITS of botulinum toxin type A).

Marketing Authorization Holder  

ABBVIE

10 ARCUEIL STREET

94528 RUNGIS CEDEX

Marketing Authorization Operator  

ABBVIE

10 ARCUEIL STREET

94528 RUNGIS CEDEX

Manufacturer  

ALLERGAN PHARMACEUTICALS IRELAND

CASTLEBAR ROAD

WESTPORT

CO. MAYO

IRELAND

Names of the medicine in the Member States of the European Economic Area  

Not applicable.

The last date this notice was revised is:  

[to be completed later by the holder]

{month YYYY}.

Others  

Detailed information on this medicine is available on the ANSM (France) website.

The following information is intended for healthcare professionals only:

FOR HEALTHCARE PROFESSIONALS

Please refer to the Summary of Product Characteristics for complete information on prescribing BOTOX.

BOTOX injection should be performed by physicians with the necessary qualifications and experience in the treatment and use of the required equipment. Buy Botox Cosmetic 50 Units

Botulinum toxin units are not interchangeable between products. The recommended doses in ALLERGAN UNITS are different from those recommended for other botulinum toxin preparations.

BOTOX is indicated for the local symptomatic treatment of spasticity (muscle hyperactivity) of the upper and/or lower limbs in patients aged 2 years and older, oculomotor disorders, blepharospasm, hemifacial spasm, spasmodic torticollis, severe persistent axillary hyperhidrosis in patients aged 12 years and older, idiopathic overactive bladder and neurological detrusor overactivity in adults.

The safety and efficacy of BOTOX in indications other than those described in section 4.1 of the Summary of Product Characteristics (SmPC) for the paediatric population have not been established. In the paediatric population, no dosage recommendations can be made for indications other than the local symptomatic treatment of spasticity. Currently available data by indication are described in sections 4.2, 4.4, 4.8, 5.1 of the Summary of Product Characteristics (SmPC) as shown in the table below.

Oculomotor disorders	12 years (see sections 4.4 and 4.8 of the SPC)
Blepharospasm/Hemifacial spasm	12 years (see sections 4.4 and 4.8 of the SPC)
Cervical dystonia	12 years (see sections 4.4 and 4.8 of the SPC)
Local symptomatic treatment of spasticity	2 years (see sections 4.2, 4.4 and 4.8 of the SPC)
Severe axillary hyperhidrosis	12 years (limited experience in adolescents aged 12 to 17 years, see sections 4.4, 4.8 and 5.1 of the SPC)
Neurological detrusor overactivity in children	5-17 years (see sections 4.8 and 5.1)
Overactive bladder in children	12-17 years (see sections 4.8 and 5.1)

No specific dosage adjustment is required for use in elderly subjects. Buy Botox Cosmetic 50 Units

The initial dosage should start at the minimum dose recommended for each indication.

In case of repeated injections, the lowest effective dose associated with the longest clinically necessary interval between two injections is recommended.

Elderly subjects with significant medical history and receiving concomitant medication should be treated with caution.

Optimal doses that can be injected and the number of injection sites per muscle have not been established for all indications. An individual treatment regimen should be defined by the physician. Optimal doses should be determined by titration without injecting beyond the maximum recommended dose. As with any drug treatment, the initial dosage in a drug-naïve patient should start at the lowest effective dose.

Dosage and method of administration (see sections 4.2 and 4.4 of the SPC)

All indications:

Adverse reactions related to the spread of the toxin away from the site of administration have been reported. These reactions have sometimes been fatal, which in some cases were associated with dysphagia, pneumonia and/or significant weakness.

Symptoms are consistent with the mechanism of action of botulinum toxin and have been reported within hours to days after injection. The risk of symptoms is likely to be higher in patients with underlying disease and comorbidities that predispose them to these symptoms, such as adults and children treated with high doses for spasticity.

Patients receiving therapeutic doses may also experience excessive muscle weakness. Pneumothorax associated with the injection procedure has been reported following administration of BOTOX near the thorax. Caution should be exercised when injecting near the lung, particularly the apical region or other vulnerable anatomical structures.

Adverse events, which can be fatal, have been reported in patients who received BOTOX injections in indications not listed in the marketing authorisation, such as directly into the salivary glands, the oropharyngolingual region, the oesophagus and the stomach. Some patients already suffered from dysphagia or significant general fatigue. Buy Botox Cosmetic 50 Units

Rare cases of death have been spontaneously reported. These were sometimes associated with aspiration pneumonia in children with severe cerebral palsy following injection with botulinum toxin, including during off-label use such as in the neck region.

Extreme caution is advised when treating pediatric subjects with significant neurologic weakness, dysphagia, or a recent history of aspiration pneumonia or lung disease.

An anaphylactic reaction may very rarely occur after injection of botulinum toxin. Epinephrine (adrenaline) and other anti-anaphylactic measures should therefore be available.

For complete information on BOTOX products, please refer to the respective Summaries of Product Characteristics.

In case of treatment failure after the first injection session, i.e. in the absence, one month after the injection, of significant clinical improvement compared to the patient’s initial condition, the following measures should be taken:

· Clinical verification, which may include an electromyographic examination in a specialized department, of the action of the toxin on the injected muscle(s);

· Analysis of the causes of failure such as poor selection of muscles to be injected, insufficient dose, poor injection technique, the appearance of a fixed contracture, antagonist muscles too weak, formation of antibodies neutralizing the toxin;

· Reassessment of the relevance of treatment with botulinum toxin type A;

In the absence of any adverse effects secondary to the first injection session, initiate a second injection session by i) adjusting the dose taking into account the analysis of the failure of the previous injection session; ii) performing an electromyogram; iii) maintaining an interval of 3 months between the two injection sessions.

If treatment fails or the effect is reduced following repeated injection sessions, an alternative treatment should be considered.

Product preparation

If different presentations of BOTOX are used in an injection procedure, care must be taken to use the correct amount of solvent by reconstituting the number of units per 0.1 ml determined. The amount of solvent varies between BOTOX 50 UNITS ALLERGAN, BOTOX 100 UNITS ALLERGAN and BOTOX 200 UNITS ALLERGAN. Each syringe will be labeled accordingly.

The preparation of the product must be carried out in a suitable room and by experienced personnel in order to minimise the risk of accidents during handling.

To reconstitute BOTOX, use only sterile, unpreserved saline solution ( 0.9 percent sodium chloride injection).

Draw up a quantity of solvent suitable for the desired dilution into a syringe of suitable size (see dilution table below).

Clean the central part of the rubber stopper with alcohol. To avoid denaturing the product, carefully inject the solvent into the bottle and shake gently, avoiding the formation of bubbles.

Do not use the bottle if the vacuum does not cause the solvent to be drawn into the bottle.

Once reconstituted, the solution obtained must be visually inspected before use, in order to verify that it is clear, colorless or very pale yellow and that it does not contain particles.

After reconstitution in its vial, from a microbiological point of view, immediate use of the solution is recommended. However, the solution can be stored in the refrigerator and used within 24 hours (see section 6.4 of the SPC – “Special precautions for storage”).

Instructions for reconstitution in the treatment of bladder dysfunction

When BOTOX is diluted in a syringe for the treatment of bladder dysfunction, it should be used immediately.

Instructions for reconstitution of BOTOX 100 ALLERGAN UNITS to obtain a dose of 50 ALLERGAN UNITS

It is recommended to preferentially use vials of BOTOX 100 UNITS ALLERGAN in order to facilitate reconstitution in this indication.

· Reconstitute 1 vial of BOTOX 100 UNITS ALLERGAN, with 8 ml of sterile, preservative-free physiological serum solution ( 0.9 percent sodium chloride injection solution) then mix the vial gently.

· Draw 4 ml from the vial into a 10 ml syringe.

· Complete the reconstitution by adding 6 ml of sterile, unpreserved physiological saline solution ( 0.9 percent sodium chloride injection ) into the 10 ml syringe and shake gently.

This will give you a 10 ml syringe containing a total of 50 Units of reconstituted BOTOX solution.

Instructions for reconstitution of BOTOX 50 ALLERGAN UNITS to obtain a dose of 100 ALLERGAN UNITS

· Reconstitute 2 vials of ALLERGAN BOTOX 50 UNITS, each with 5 ml of sterile, unpreserved physiological serum solution ( 0.9 percent sodium chloride injection ) and mix the vial gently.

· Draw 5 ml from each vial into a 10 ml syringe.

This will give you a 10 ml syringe containing a total of 100 Units of reconstituted BOTOX solution.

Instructions for reconstitution of BOTOX 100 ALLERGAN UNITS to obtain a dose of 100 ALLERGAN UNITS

· Reconstitute 1 vial of BOTOX 100 UNITS ALLERGAN with 10 ml of sterile, preservative-free physiological serum solution ( 0.9 percent sodium chloride injection ) and shake the vial gently.

· Withdraw 10 ml of the reconstituted solution from the vial into a 10 ml syringe.

This will give you a 10 ml syringe containing a total of 100 Units of reconstituted BOTOX solution.

Instructions for reconstitution of BOTOX 200 ALLERGAN UNITS to obtain a dose of 100 ALLERGAN UNITS

It is recommended to preferentially use vials of BOTOX 100 UNITS ALLERGAN in order to facilitate reconstitution in this indication.

· Reconstitute 1 vial of BOTOX 200 UNITS ALLERGAN, with 8 ml of sterile, preservative-free physiological serum solution ( 0.9 percent sodium chloride injection solution ) then mix the vial gently.

· Draw 4 ml from the vial into a 10 ml syringe.

· Complete the reconstitution by adding 6 ml of sterile, unpreserved physiological saline solution (0.9 percent sodium chloride injection ) into the 10 ml syringe and mix gently.

This will give you a 10 ml syringe containing a total of 100 Units of reconstituted BOTOX solution.

Instructions for reconstitution of BOTOX 50 ALLERGAN UNITS to obtain a dose of 200 ALLERGAN UNITS

It is recommended to preferentially use vials of BOTOX 100 UNITS ALLERGAN or BOTOX 200 UNITS ALLERGAN in order to facilitate reconstitution in this indication.

· Reconstitute 4 vials of ALLERGAN BOTOX 50 UNITS, each with 3 ml of sterile, unpreserved physiological serum solution ( 0.9 percent sodium chloride injection ) and mix the vials gently.

· Withdraw 3 ml from the first vial and 1 ml from the second vial with a 10 ml syringe.

· Withdraw 3 ml from the third vial and 1 ml from the fourth vial with a 10 ml syringe.

· Aspirate the remaining 2 ml from the second and fourth vials with a third 10 ml syringe.

· Complete the reconstitution by adding 6 ml of sterile, unpreserved physiological saline solution ( 0.9 percent sodium chloride injection ) to each of the 10 ml syringes and mix gently.

This will give you three 10 ml syringes containing a total of 200 Units of reconstituted BOTOX solution.

Instructions for reconstitution of BOTOX 100 ALLERGAN UNITS to obtain a dose of 200 ALLERGAN UNITS

· Reconstitute 2 vials of ALLERGAN BOTOX 100 UNITS, each with 6 ml of sterile, unpreserved physiological serum solution ( 0.9 percent sodium chloride injection ) and mix the vials gently.

· Withdraw 4 ml from each vial using 2 10 ml syringes.

· Draw up the remaining 2 ml in each vial with a third 10 ml syringe.

· Complete the reconstitution by adding 6 ml of sterile, unpreserved physiological saline solution ( 0.9 percent sodium chloride injection ) to each of the 10 ml syringes and mix gently.

This will give you three 10 ml syringes containing a total of 200 Units of reconstituted BOTOX solution.

Instructions for reconstitution of BOTOX 200 ALLERGAN UNITS to obtain a dose of 200 ALLERGAN UNITS

· Reconstitute 1 vial of BOTOX 200 UNITS ALLERGAN with 6 ml of sterile, preservative-free physiological serum solution ( 0.9 percent sodium chloride injection solution) and then mix the vial gently.

· Draw 2 ml from the vial into each of the 3 10 ml syringes.

· Complete the reconstitution by adding 8 ml of sterile, unpreserved physiological saline solution (0.9 percent sodium chloride injection) to each of the 10 ml syringes and mix gently.

This will give you three 10 ml syringes containing a total of 200 Allergan Units of reconstituted BOTOX solution.

Dilution table – Other indications

Recommendations in the event of an accident when handling botulinum toxin

In the event of an accident when handling the product, whether in powder or reconstituted form, the appropriate measures described below must be taken immediately.

Botulinum toxin is very sensitive to heat and certain chemical agents.

Any projections must be wiped off:

· either with absorbent material soaked in a sodium hypochlorite solution (bleach) in the case of a dry product;

· either with dry absorbent material in the case of a reconstituted product.

Contaminated surfaces will be cleaned with absorbent material soaked in a sodium hypochlorite solution (bleach), then dried.

If the bottle breaks, proceed as indicated above to carefully collect the glass particles and wipe off the product, avoiding skin cuts.

If splashed, wash with sodium hypochlorite solution (bleach), then rinse thoroughly with water.

In case of eye splash, rinse thoroughly with water or ophthalmic eye wash solution.

In the event of injury to the handler (cut, self-prick), proceed as above and take appropriate medical measures depending on the dose injected.

Recommendations for disposal of used equipment

Needles, syringes and vials, which must not be emptied, will be placed, after use, in suitable containers which must be incinerated.

Contaminated material (absorbent tissue, gloves, ampoule debris) must be placed in a spill-proof bag and disposed of by incineration.

Product identification

To verify that the product you received as BOTOX is a genuine ALLERGAN product, look for a tamper-evident seal with a translucent silver ALLERGAN logo on the top and bottom flaps of the carton, and a holographic overlaminate on the bottle label. To see this overlaminate, examine the bottle under a desk lamp or fluorescent light source. Rotate the bottle back and forth between your fingers to see multi-colored horizontal lines and look for the word “ALLERGAN” between the multi-colored horizontal lines.

Do not use the product and contact ABBVIE for further information if:

· The multi-coloured horizontal lines or the word “ALLERGAN” are not present on the bottle label;

· The tamper evident label is not intact or present at both ends of the box;

· The translucent silver ALLERGAN logo is not clearly visible or is surrounded by a black circle with a diagonal line through it (like the prohibition symbol).

In addition, ALLERGAN has added removable labels to the BOTOX vial label that indicate the lot number and expiration date of the product. These labels can be peeled off and placed in your patient’s file to ensure product traceability. The word “USED” will appear once the traceability label is peeled off the vial label, confirming that you are using an authentic BOTOX vial manufactured and supplied by ALLERGAN.

FillerSupplies – The Best Place to Buy Botox Online

FillerSupplies is an international retail & wholesale supplier of Botox, botulinum toxins, and other solutions of aesthetic medicine and skincare products (hyaluronidase, anesthetics, creams, threads, or ophthalmology drugs).

How to buy Allergan Botox in a bottle at Fillersupplies?

You can safely purchase a Botox kit in one of the following ways:

• By adding Botox to your cart and submitting the order;
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At FillerSupplies online store, every registered customer can order high-quality Botox online both retail and wholesale. Our store offers discounts to those who buy in large quantities and Free 1–5 day delivery over $500. Feel free to check FillerSupplies wholesale prices by visiting the product pages, such as Botox 100 Units, 50 Units, and many others. Buy Botox Cosmetic 50 Units

Is it legal to Buy Botox Online?

Botox is a botulinum toxin product elaborated and patented by the French-American manufacturer Allergan and FDA approved. It is both a cosmetic and therapeutic drug. Apart from being used for aesthetic purposes, it is applied to treat such serious medical conditions as:

• Blepharospasm;
• Cerebral palsy;
• Limb spasticity;
• Overactive bladder;
• Urinary retention;
• Severe primary axillary hyperhidrosis;
• Chronic migraine;
• Episodic migraine;
• Cervical dystonia;
• Neck pain.

Botox injections should be performed only by experienced licensed professionals who has received proper training and certification in administering Botox. Please note that the application of the product by non-professionals might be health and life-threatening.

However, you can legally buy Allergan Botox online in the USA if you hold a license that proves that you are a certified medical professional. By means of providing it to us, you will obtain a right to buy and use Botox and other botulinum toxin products in your medical practice. Buy Botox Cosmetic 50 Units

In case of having a license, you can safely place an Allergan Botox order online on FillerSupplies:

• Register your personal account;
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• Proceed with the payment;
• Wait for your license to be verified by our managers;

In case you need any assistance with the registration, payment, or any other aspect of the purchasing process, contact the FillerSupplies team. As well, feel free to reach out to us if you have questions regarding the prices, shipment, delivery, service, and so on. Remember, the FillerSupplies customer support service is always ready to help you out.

When deciding to order Botox online or dermal fillers online on FillerSupplies.com, you might be sure that you buy 100% authentic top-quality products and, therefore, guarantee your patient the best possible result after the procedure. Buy Botox Cosmetic 50 Units

How Much Does Botox vials Cost?

The average Botox price depends on several factors. Namely, it is determined by the product’s type, volume, package, and supplier. Here is how Botox costs vary:

• There exist two main types of Botox, namely medical and cosmetic. While the first is used to treat muscle-related health issues, the latter is applied in aesthetic medicine. In most cases, medical Botox tends to be more expensive than the cosmetic one.
• Botox is usually sold in a variety of different volumes. Among the most popular ones are Botox 50IU and Botox 100IU. Naturally, the bigger the product’s volume is, the more it will cost.
• Depending on the market Botox is targeted to, it is advertised in different packages, such as European, Polish, Indian, and so on. Basically, you might come across a more expensive English or cheaper non-English Botox packaging.
• Each supplier of cosmetic injectables sets its own Botox price. As well, it might or might not provide its customers with wholesale discounts, special deals, and other price benefits.

As well, the average cost of Botox injections depends on the health care practitioner who is going to perform the procedure. Buy Botox Cosmetic 50 Units

Take a closer look at the detailed overview of the average price for Botox 2024 in the table below:

Hopefully, the above-mentioned table will help you to find the most appropriate type of Botox. So, make your decision and place your order on FillerSupplies, a reliable supplier of cosmetic injectables at the best possible prices! Buy Botox Cosmetic 50 Units

What basic information should you know about Botox?

Apart from their therapeutic purposes, injections of Botox (Botulin toxin A) are famous to be the powerful means to fight the signs of natural aging. Namely, they are used to efficiently eliminate dynamic wrinkles on the forehead, under the eyes, and around the mouth.

Due to the fact that recent implications of Botox have gone even further, there are lots of studies and cases of adult patients being treated with Botox to lift breasts, take care of erectile dysfunction, manage premature ejaculation, eliminate the effect of a gummy smile, or fight excessive sweating. Moreover, scientists are not going to stop exploring new and new applications of botulinum toxin to improve people’s health and quality of life. Buy Botox Cosmetic 50 Units

A few words on the history of Botox

Botulin toxin type A is synthesized by anaerobic bacteria (microorganisms) that belong to the Clostridium family.

The first medical application of Botox occurred in 1960. Before this time, it was considered to be a dreadful poison that caused a health condition called botulism, which might be characterized as poisoning (mainly a result of eating poisoned meat products) that is accompanied by full or partial paralysis of the organism with the possibility of fatal consequences. However, a group of Canadian scientists managed to “tame” the dangerous poison, providing a great number of patients with an opportunity to cure a variety of diseases (not only cosmetic issues) and, therefore, radically change their lives. Buy Botox Cosmetic 50 Units

Please note: In 1960, doctors used Botox to treat partial and complete paralysis of the facial nerve, lower and upper limb spasticity, urge urinary incontinence, overactive bladder, hyperhidrosis, migraine, etc. The main reason for it is that the injection of botulin toxin stimulates muscle relaxation and, therefore, helps to relieve the symptoms of the above-mentioned medical conditions.

These days, doctors apply Botox to treat heavy headaches, cerebral palsy, strabismus, and other diseases of the nervous system. In addition, botulin therapy might be used by orthodontists to cure bruxism (or, as it is also called, teeth grinding). Buy Botox Cosmetic 50 Units

Botox working principle

The working principle of botulinum toxin is pretty straightforward. Under normal circumstances, it acts locally. Namely, the substance has the power to disrupt the transmission of the nerve impulse from the nerve end to the muscle, thereby relaxing this particular muscle.

The method botulinum toxin helps to eliminate mimic wrinkles depends directly on the way they form. Facial expressions such as laughing, smiling, crying, frowning, etc., involve an active movement and contraction of facial muscles. For example, every time a person smiles, the respective facial muscle contracts, and, therefore, squeezes the skin. Depending on a person’s age, this process leads to different results:

• At a young age, the skin has lots of collagen and elastin. These substances quickly fill in the creases that occurred as a result of smiling. Therefore, there is not even a trace of them on the skin surface;
• At a more senior age, however, active facial expressions lead to the formation of creases. The main reason for it is that the skin deposits of hyaluronic acid and collagen decrease as a person gets older. Therefore, there occur pronounced wrinkles around the eyes if a person squints the eyes, as well as furrow lines on the forehead or between the eyebrows if a person frowns too often.

Luckily, the Botox working principle comes in handy to treat the above-mentioned wrinkles. Here is how it works: when botulinum toxin penetrates the dermal tissues, its molecules bind to the proteins on the edges of the nerve fibers, preventing them from receiving brain signals. As a result, the tension in the tissues gradually decreases, muscles relax, and wrinkles vanish. Buy Botox Cosmetic 50 Units

Expected Botox result

When speaking about the expected result of the cosmetic application of Botox, it is essential to mention that it will be observed on the second day after the procedure. It will gradually show up and become clearly visible in two weeks after the treatment. The final result will persist for 3-5 months and gradually weaken afterward. So the injection of Botox should be repeated from time to time if the patient wants to remain smooth and wrinkle-free skin. Buy Botox Cosmetic 50 Units

Please note: Botox acts in several stages. It is the main reason why the first effect of it might become visible in 2-7 days after the injection. While the peak of Botox action, in its turn, will occur near the end of the second month after the procedure. After that, it gradually weeks as the organism starts to grow new nerve fibers. Buy Botox Cosmetic 50 Units

Contraindications

Botulinum toxin that is used in modern products (including Botox), is highly purified and refined. Therefore, it is safe to be used for the treatment of both adults and children. Moreover, it is one of the best well-studied medications with hundreds of clinical trials and experiments. Thus, it rarely leads to serious complications. Buy Botox Cosmetic 50 Units

Nevertheless, Botox treatment is not for everybody. Patients with the following health conditions are not regarded to be suitable candidates for both therapeutic and cosmetic Botox injections:

• Resistance (or, in other words, insensitivity) to Botox;
• Pregnancy and breast-feeding;
• Violation of the skin integrity at the injection area;
• Oncological diseases;
• Chronic diseases in the phase of exacerbation (on the moment of injection).

Only patients with none of the above-mentioned diagnoses are allowed to undergo the procedure of Botox injection. Buy Botox Cosmetic 50 Units

Possible side effects

Those who do not have any contraindications to the administration of Botox should be informed about its possible side effects. Botulinum toxin is a foreign substance, so the body might react to it in certain ways, such as:

• Pain at the injection site;
• Redness;
• Swelling;
• Itching;
• Bruising;
• Skin sensitivity;
• Tissue discoloration;
• Headache;
• Nausea.

These are temporary reactions of the organism that should disappear in a few hours or days after the treatment. In case of worsening of the patient’s well-being, it is recommended to contact the doctor immediately. To minimize the pain, the patient can use painkillers or apply a pack of ice to the area of the treatment. Buy Botox Cosmetic 50 Units

Cosmetic Treatment with Botox

Initially, Botox has been used only for therapeutic purposes. However, while treating blepharospasm by means of administering botulinum toxin in the eye muscle, the scientists noticed that the substance smoothed out the under-eye wrinkles so that the patients acquired a younger appearance. It has set a start to a cosmetic era of Botox for the elimination of mimic wrinkles with the aim of facial rejuvenation.

The above-mentioned moment introduced Botox into cosmetology. These days, it is extensively used for wrinkle reduction on the forehead, nose bridge, and near the eye. Moreover, it is applied to correct the skin imperfections in the lower third of the face (however, please note that the wrong application of Botox may temporarily hurt the facial expression of a patient). Buy Botox Cosmetic 50 Units

So, here is the list of the most common Botox injection sites:

• Forehead;
• Glabellar region;
• Periorbital area;
• Perioral area.

Please note: The usage of Botox for cosmetic purposes requires a doctor to be specially trained, skilled, and experienced. Otherwise, there is a possibility to relax the wrong muscle, which might harm a patient’s appearance, create facial asymmetry, make mouth corners drop, and so on. Thus, injections of botulin toxin require excellent knowledge of human anatomy.

It is also important to understand that botulin toxin is not able to smooth out static wrinkles completely. In other words, it cannot eliminate deep skin imperfections that occurred as a result of natural aging (namely, the decrease of hyaluronic acid and collagen in the dermal tissues). However, botulinotherapy is very effective in treating dynamic wrinkles and preventing the formation of new ones. Buy Botox Cosmetic 50 Units

Please note: If a patient needs to eliminate static wrinkles rather than dynamic ones, injections of dermal fillers might be considered.

Botox for the treatment of hyperhidrosis

Wrinkle smoothing is not the only application of Botox therapy. In addition, botulin toxin is also used to temporarily weaken the activity of sweat glands, and, therefore, solve the unpleasant problem of excessive sweating.

For the treatment of the so-called hyperhidrosis, Botox might be injected into the armpits, palms, feet, and groins. When being more precise, it should be administered superficially and in large quantities in order to stop sweat secretion. Buy Botox Cosmetic 50 Units

The halt of excessive sweating is achieved due to the violation of the transmission of the nerve impulse to the sweat gland. As a result, a patient notices a considerable decrease in sweat secretion for the time period that equals 4-6 months.

Please note: The degree of sweating might be determined with the help of an iodine test: the cosmetologist dryly wipes a certain area (for example, underarms), applies iodine, and after that sprinkles with starch. In those places that have strongly blackened, there is the highest concentration of sweat glands. Buy Botox Cosmetic 50 Units

There is one essential thing that has to be mentioned when discussing the usage of Botox for the treatment of hyperhidrosis. While injecting botulin toxin into one area (for instance, underarms), the cosmetologist should warn the patient that sweat may start to exude from another area (for example, back). However, it will happen only in extreme for the organism conditions, such as high temperatures, active sports, etc. In other cases, it should not be noticeable. As well, please keep in mind that botulin toxin can not be injected in all places at the same time, while sweating is a necessary process for controlling the body temperature. Buy Botox Cosmetic 50 Units

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FillerSupplies offers a wide range of benefits to its customers, including an extensive selection of brand-name products, competitive wholesale discounts, reliable shipping options, and more—ensuring the best possible shopping experience.

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Thanks to wholesale discounts and special offers, FillerSupplies allows you to save up to 40% on authentic dermal fillers, botulinum toxins, and other cosmetic injectables.

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