Patient leaflet - BOTULINUM TOXIN TYPE A 300 UNITS POWDER FOR SOLUTION FOR INJECTION
1. What Botulinum Toxin Type A is and what it is used for
2. What you need to know before you are given Botulinum Toxin Type A
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3. How Botulinum Toxin Type A is given
4. Possible side effects
5. How to store Botulinum Toxin Type A
6. Contents of the pack and other information
1. what botulinum toxin type a is and what it is used for
Botulinum Toxin Type A contains the active substance Clostridium botulinum type A toxinhaemagglutinin complex.
What Botulinum Toxin Type A is used for:
Adults:
Botulinum Toxin Type A is used in adults to treat muscle spasms:
- Around the eyes
- In the face
- In the neck
- In the arm and shoulders
- In the leg
Botulinum Toxin Type A is also used in adults for:
- The temporary improvement in the appearance of moderate to severe glabellar lines (the vertical frown lines between the eyebrows) and lateral canthal lines (crow’s feet lines), in patients under 65 years of age
- Hyperhidrosis. This is a condition where there is excess sweating of the armpits, which interferes with daily living.
Children:
Botulinum Toxin Type A is used in children with cerebral palsy (aged two years or older):
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– to treat muscle spasms in the legs, to improve their walking
to treat muscle spasms in the arms.
How Botulinum Toxin Type A works:
Botulinum Toxin Type A contains a toxin produced by the bacterium Clostridium botulinum. It works by stopping your muscles contracting. It does this by stopping the release of a chemical which acts between the nerves and muscles that makes the muscles contract. This helps to reduce abnormal muscle contractions known as spasms.
Botulinum Toxin Type A can also be used to prevent the muscles, which cause frown lines and crow’s feet lines, from contracting. This muscle relaxation is temporary and gradually wears off. Some people are distressed when lines appear on their face.
2. what you need to know before you are given botulinum toxin type a
Do not use Botulinum Toxin Type A:
If you are allergic to botulinum toxin type A or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions:
There are increased risks of having Botulinum Toxin Type A injections under any of these circumstances. Talk to your doctor, pharmacist or other healthcare practitioner before using Botulinum Toxin Type A if:
- You have problems swallowing
- You have any history of bronchitis, pneumonia or problems with breathing
- You have had an allergic reaction to a botulinum toxin in the past
- You have other problems or diseases that affect your muscles e.g. myasthenia gravis
- You bleed easily
- You have an infection where the injection will be given or if that area is swollen
- The muscles at the proposed site of injection are weak or show signs of wasting
- You have had surgery on your face, or are likely to undergo facial surgery or other types of
surgery soon (if you are considering treatment for glabellar lines or lateral canthal lines)
- You had no significant improvement of your lines after your last treatment (if you are considering treatment for glabellar lines or lateral canthal lines).
When Botulinum Toxin Type A is used in the treatment of persistent muscle spasms in the eyelid and face or used to improve the appearance of glabellar lines and/or lateral canthal lines, your eyes may become dry. Botulinum Toxin Type A may make your eyes blink less often or produce less tears, which could harm the surface of your eyes (see section 4).
Children and adolescents:
For the treatment of spasticity associated with cerebral palsy in children, Botulinum Toxin Type A should only be used in children 2 years of age or over.
Botulinum Toxin Type A is not indicated for the treatment of glabellar lines and lateral canthal lines, in patients under the age of 18 years.
Other medicines and Botulinum Toxin Type A:
Please tell your doctor or healthcare practitioner if you are taking any antibiotics for an infection (e.g. aminoglycosides such as gentamicin or amikacin) or muscle relaxing drugs. Some of these medicines may increase the effect of Botulinum Toxin Type A.
Tell your doctor or pharmacist or other healthcare practitioner if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility:
Botulinum Toxin Type A is not recommended during pregnancy, unless clearly necessary.
Botulinum Toxin Type A is not recommended in breast-feeding women.
Botulinum Toxin Type A may affect fertility, when given at high doses.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist or other healthcare practitioner for advice before taking this medicine.
Driving and using machines:
Botulinum Toxin Type A may cause muscle weakness or problems with your vision.
If you experience any of these effects, do not drive or use any machines.
3. How Botulinum Toxin Type A is given
Botulinum Toxin Type A must only be injected by doctors or healthcare practitioners with specific skills and experience on how to use the medicine.
Your doctor or healthcare practitioner will choose your dose of medicine and decide how often you need treatment. This will depend on what you are being treated for.
A vial of Botulinum Toxin Type A should be used only for you and only for a single treatment session.
Adults:
For treatment of muscle spasms in your arm and shoulder:
The dose of Botulinum Toxin Type A will usually be between 500 and 1000 units. The doctor or healthcare practitioner may divide the amount between the affected arm and shoulder muscles. Your muscle spasms should normally improve within 1 week and this improvement may last up to 20 weeks. Injections will usually be given about every 12 to 16 weeks, depending on how long the effect lasts, but not more frequently than every 12 weeks.
For treatment of muscle spasms in your leg :
The dose of Botulinum Toxin Type A will usually be up to 1500 units and should not exceed this dose. The doctor or healthcare practitioner may divide the amount between the affected leg muscles.
Injections will usually be given about every 12 to 16 weeks, or longer as necessary, but not more frequently than every 12 weeks.
For treatment of muscle spasms in your arm and leg :
If you need to receive injections in your arm and leg in the same treatment session, your doctor or healthcare practitioner may divide the dose between your arm and leg in line with the approved dose recommendations, but the overall dose must not exceed 1500 units.
For treatment of muscle spasms in your neck:
The first dose of Botulinum Toxin Type A will usually be 500 units divided into a number of places in the neck, probably into 2 or 3 of the neck muscles most affected by the condition. A smaller amount may be given to very underweight or elderly patients. Your muscle spasms should improve within 1 week. Further injections (250 – 1000 units) will be given by your doctor or healthcare practitioner about every 16 weeks depending on how long the effect lasts or as required to maintain a response, but not more frequently than every 12 weeks. The maximum dose should not exceed 1000 units.
For treatment of muscle spasm around your eyes:
The first injection will usually be 40 units per eye. The medicine will be injected just under the skin at various sites around the eye. If only one eye is affected, the doctor or healthcare practitioner will only give injections of Botulinum Toxin Type A around this eye. Your muscle spasms should normally start improving within 2 – 4 days with maximal effect within 2 weeks. Injections will be given about every 12 weeks depending on how long the effects last, but not more frequently than every 12 weeks. On the next visits, the amount of Botulinum Toxin Type A given may be increased to a maximum of 120 units per eye.
For treatment of muscle spasm in your face:
The doctor or healthcare practitioner will give you injections on the side of your face that is affected. The first injection will usually be 40 units. Injections will be given about every 12 weeks depending on how long the effects last, but not more frequently than every 12 weeks. On the next visits, the amount of Botulinum Toxin Type A given may be increased to a maximum of 120 units.
For treatment of excessive sweating of your armpits :
The first dose will usually be 100 units per armpit. The doctor or healthcare practitioner may divide this amount between the affected areas. Your symptoms should usually improve within 2 weeks and the effect can last for up to approximately 48 weeks. The amount of the next dose your doctor or healthcare practitioner gives you, and when you will be given a further injection will depend on how you respond. The minimum time between treatments is 12 weeks. The maximum dose you should be given is 200 units per armpit.
Children with cerebral palsy (aged two years or older):
For treatment of muscle spasms in the legs of children with cerebral palsy :
Children over 2 years: The dose is decided by your doctor or healthcare practitioner. Botulinum Toxin Type A is injected into the affected muscles of the legs. The dose must not be higher than 1000 units or 30 units/kg at a given treatment session, whichever is lower. Your muscle spasms should normally improve within 2 weeks and this improvement may last up to 28 weeks. Your doctor or healthcare practitioner will repeat the treatment approximately every 16 – 22 weeks or as needed, but no more frequently than every 12 weeks.
For treatment of muscle spasms in the arms of children with cerebral palsy:
Children 2 years or older: The dose is decided by your doctor or healthcare practitioner. Botulinum Toxin Type A is injected into the affected muscles of the arms. The dose must not be higher than 840 units or 21 units/kg at a given treatment session, whichever is lower. Your muscle spasms should normally improve in the weeks following treatment and this improvement may last up to 34 weeks. Your doctor or healthcare practitioner will repeat the treatment approximately every 16 – 28 weeks or as needed, but no more frequently than every 16 weeks.
For treatment of muscle spasms in the arms and legs of children with cerebral palsy:
If treatment is required in the arms and legs during the same treatment session, the dose of Botulinum Toxin Type A to be injected in each limb should be decided by your doctor or healthcare practitioner, without exceeding a total dose per treatment session of 1000 units or 30 units/kg, whichever is lower. Your doctor or healthcare practitioner will repeat the treatment as needed, but no sooner than 12 – 16 weeks after the previous treatment session.
For temporary improvement of glabellar lines and/or lateral canthal lines:
Botulinum Toxin Type A should only be administered by physicians or healthcare practitioners with appropriate qualifications and expertise in this treatment and having the required equipment.
Your doctor or healthcare practitioner will prepare and give the injections. A vial of Botulinum Toxin Type A should be used only for you and only for a single treatment session.
The recommended dose is:
- For glabellar lines: 50 units, injected as 10 units at each of 5 injection sites in your forehead in the area above your nose and eyebrows.
- For lateral canthal lines: 60 units, injected as 10 units at each of 6 injection sites in both crow’s feet regions.
The units used for different botulinum toxin products are not the same. Botulinum Toxin Type A units are not interchangeable with other botulinum toxin products.
The effect of the treatment should be noticeable within a few days after injection. The interval between treatments with Botulinum Toxin Type A will be decided by your doctor or healthcare practitioner. You should not have treatment more often than every 12 weeks.
If you are given more Botulinum Toxin Type A than you need
If you are given more Botulinum Toxin Type A than you need, muscles other than the ones that were injected may begin to feel weak. This may not happen straight away. If this does happen, speak to your doctor or healthcare practitioner immediately. Seek urgent medical help if you have difficulty breathing, swallowing or speaking.
If you forget an injection of Botulinum Toxin Type A
Nothing will happen if an injection is missed other than some of the spasm or muscle stiffness may return. Tell your doctor or healthcare practitioner and he will decide when the next injection is needed.
If you stop taking Botulinum Toxin Type A
Your muscle spasms will return to the way they were before treatment.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or other healthcare practitioner.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Botulinum Toxin Type A may in rare cases cause side effects away from its site of injection.
Seek urgent medical help if:
- You have any problems swallowing, breathing or with your speech or you have worsened muscle weakness.
- You develop difficulty in breathing with or without swelling of the face, lips, tongue and/or throat, redness of the skin or an itchy lumpy rash (urticaria). This may mean you are having an allergic reaction to Botulinum Toxin Type A.
Some side effects may occur in any patient treated with Botulinum Toxin Type A whilst other side effects may depend on the condition being treated.
Make sure you read all the sections that apply to you.
Treatment of any condition (all patients) :
Common: may affect up to 1 in 10 people
- Bruising, or pain around the site where the injection was given
- Generalised weakness
- Tiredness
- Flu-like symptoms.
Uncommon: may affect up to 1 in 100 people
- Itching.
Rare: may affect up to 1 in 1,000 people
- Skin rashes
- Sudden severe pain and weakness in shoulder and/or arm (neuralgic amyotrophy). Not known: (frequency cannot be estimated from the available data)
- Numbness
- Muscle wasting.
Treatment of muscle spasms in the arm and shoulder of adults :
Common: may affect up to 1 in 10 people
- Muscle weakness
- Musculoskeletal pain
- Pain in the hands and fingers.
Uncommon: may affect up to 1 in 100 people
- Difficulty in swallowing.
Treatment of muscle spasms in the leg of adults :
Common: may affect up to 1 in 10 people
- Difficulty in swallowing
- Leg muscle weakness
- Muscle pain
- Fall.
Treatment of muscle spasms in the eyes or face :
Very common: may affect more than 1 in 10 people
- Drooping of the upper eyelid.
Common: may affect up to 1 in 10 people
- Double vision
- Swelling of the eyelid
- Facial muscle weakness
- Dry eyes or more tears than usual.
Uncommon: may affect up to 1 in 100 people
- Facial paralysis.
Rare: may affect up to 1 in 1,000 people
- Difficulty in moving the eye
- Edge of the eyelid turning in towards the eyeball (entropion).
Treatment of muscle spasms in the neck :
Very common: may affect more than 1 in 10 people
- Muscle weakness
- Difficulty in swallowing. This side effect may be expected to resolve within 2 to 4 weeks
- Dry mouth.
Common: may affect up to 1 in 10 people
- Headache
- Dizziness
- Blurred vision or other problems in seeing clearly
- Weakness of face muscles
- Stiff muscles
- Shortness of breath
- A change to the tone of the voice
- Neck pain, muscle pain, pain in the hands and fingers.
Uncommon: may affect up to 1 in 100 people
- Loss of muscle tissue
- Jaw problems
- Drooping of the upper eyelid
- Double vision
- Nausea.
Rare: may affect up to 1 in 1,000 people
- Lung inflammation caused by accidentally breathing in food, drink, saliva or vomit (aspiration pneumonia).
Treatment of muscle spasms in the legs of children with cerebral palsy:
Common: may affect up to 1 in 10 people
- Muscle pain
- Muscle weakness
- Urinary incontinence
- Flu-like symptoms
- Pain, redness, bruising at the injection site
- Abnormal walking
- Tiredness
- Fall.
Uncommon: may affect up to 1 in 100 people
- Loss of strength and weakness.
Treatment of muscle spasms in the arms of children with cerebral palsy:
Common: may affect up to 1 in 10 people
- Muscle weakness
- Pain in the hands and fingers
- Flu-like symptoms
- Loss of strength and weakness
- Tiredness
- Bruising at the injection site
- Skin rash.
Uncommon: may affect up to 1 in 100 people
- Muscle pain
- Itchy skin at the injection site
- Pain at the injection site
- Rash at the injection site
- Swelling at the injection site.
Treatment of muscle spasms in the arms and legs of children with cerebral palsy:
There are no specific findings for the administration of Botulinum Toxin Type A at the same treatment session in the arm and leg compared to those expected from treating in the arm or the leg separately.
Temporary improvement of glabellar lines:
Very common: may affect more than 1 in 10 people
- Redness, swelling, irritation, rash, itching, tingling, pain, discomfort, stinging or bruising at the site of injection
- Headache.
Common: may affect up to 1 in 10 people
- Tired eyes or dim vision, drooping of the upper eyelid, swelling of the eyelid, watering eyes, dry eye, twitching of muscles around the eyes
- Temporary facial paralysis.
Uncommon: may affect up to 1 in 100 people
- Impaired, blurred or double vision
- Dizziness
Rare: may affect up to 1 in 1,000 people
- Itchy and lumpy rash (hives)
- Eye movement disorder
Temporary improvement of lateral canthal lines:
Common: may affect up to 1 in 10 people
- Headache
- Temporary facial paralysis
- Swelling of the eyelid
- Drooping of the upper eyelid
- Bruising, itching and swelling around the eyes.
Uncommon: may affect up to 1 in 100 people
- Dry eye
Usually these side effects, after treatment for glabellar lines or lateral canthal lines, have occurred within the first week following injections and did not last long. They were usually mild to moderate in severity.
Treatment of excessive sweating of the armpits:
Common: may affect up to 1 in 10 people
- Increased sweating in other parts of the body (compensatory sweating).
5. how to store botulinum toxin type a
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 label after ‘EXP’. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Chemical and physical in-use stability has been demonstrated for the reconstituted solution for 24 hours in a refrigerator (2°C – 8°C). After the solution is made up, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information
What Botulinum Toxin Type A contains
The active constituent of Botulinum Toxin Type A is Clostridium botulinum type A toxin-haemagglutinin complex (300 units).
The other excipients in Botulinum Toxin Type A are human albumin and lactose.
Before it is injected, Botulinum Toxin Type A will be dissolved in sodium chloride for injection (a solution of salt).
What Botulinum Toxin Type A looks like and contents of the pack
Botulinum Toxin Type A is a powder for solution for injection. It appears as a white powder in a glass vial. It comes in pack sizes of 1 or 2 vials, although not all pack sizes may be marketed.
Botulinum Toxin Type A is also available in 500 unit vials.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE, UK.
Manufacturer:
Ipsen Biopharm Limited, Ash Road, Wrexham Industrial Estate, Wrexham LL13 9UF.
Is this leaflet hard to see or read? Please phone +44 (0) 1753 627777 and ask for help.
This leaflet was last revised in November 2021.
--------DETACH HERE AND GIVE INFORMATION TO PATIENT---------------
The following information is intended for healthcare professionals only.
Please refer to the Summary of Product Characteristics for complete prescribing information for Botulinum Toxin Type A
Handling
When preparing and handling Botulinum Toxin Type A solutions, the use of gloves is recommended. If Botulinum Toxin Type A dry powder or reconstituted solution should come into contact with the skin or mucous membranes, they should be washed thoroughly with water. Reconstitution should be conducted in compliance with good practice, especially with regard to asepsis.
Botulinum Toxin Type A is supplied as a powder in a colourless injection vial and must be dissolved in sterile saline solution before use. Each vial contains 300 units of toxin-haemagglutinin complex.
The uncovered central part of the rubber stopper should be cleaned with alcohol immediately before piercing the septum. A sterile 23 or 25 gauge needle should be used.
Reconstitution instructions for 300 unit vial. These volumes yield concentrations specific for the use for each indication.
| Resulting Dose Unit per ml | Diluent* per 300U vial |
| 500U | 0.6 ml |
| 200U | 1.5 ml |
| 100U | 3 ml |
*Preservative-free 0.9 % sodium chloride injection
For paediatric cerebral palsy spasticity, which is dosed using unit per body weight, further dilution may be required to achieve the final volume for injection.
Appearance of product after reconstitution:
A clear, colourless solution, free from particulate matter
Instructions for use
The units given for Botulinum Toxin Type A are specific to the preparation and are not interchangeable with other preparations of botulinum toxin.
Instructions for the use of Botulinum Toxin Type A in the symptomatic treatment of focal spasticity affecting the upper limbs in adults, lower limbs in adults affecting the ankle joint due to stroke or traumatic brain injury, dynamic equinus foot deformity due to spastic cerebral palsy in ambulant paediatric patients two years of age or older and focal spasticity of upper limbs or upper and lower limbs in paediatric cerebral palsy patients, 2 years of age or older
300 units Botulinum Toxin Type A is diluted with 0.6 ml, 1.5 ml or 3 ml NaCl injection B.P. (0.9% w/v) to a concentration of 500 units, 200 units or 100 units Botulinum Toxin Type A per ml, respectively. Botulinum Toxin Type A must be administered intramuscularly.
Treatment of Spasmodic torticollis in adults
When treating spastic torticollis, Botulinum Toxin Type A 300 units is diluted with 0.6 ml of 0.9% sodium chloride injection to yield a solution of Botulinum Toxin Type A with a concentration equivalent to 500 units in 1 ml.
Treatment of blepharospasm and hemifacial spasm in adults
When treating blepharospasm and hemifacial spasm, Botulinum Toxin Type A 300 units is diluted with 1.5 ml of 0.9% sodium chloride injection to yield a solution of Botulinum Toxin Type A with a concentration equivalent to 200 units in 1 ml.
Botulinum Toxin Type A is administered by subcutaneous injection medially and laterally into the junction between the preseptal and orbital parts of both the upper and lower orbicularis oculi muscles of the eyes.
Treatment of Severe primary hyperhidrosis of the axillae
When treating excessive sweating, Botulinum Toxin Type A 300 units is diluted with 1.5 ml of 0.9% sodium chloride injection to yield a solution of Botulinum Toxin Type A with a concentration equivalent to 200 units in 1 ml.
Treatment of glabellar lines and/or lateral canthal lines in adults
When treating glabellar lines and/or lateral canthal lines, Botulinum Toxin Type A 300 units is diluted with 1.5 ml of 0.9% sodium chloride injection to yield a solution of Botulinum Toxin Type A with a concentration equivalent to 200 units in 1 ml.
Botulinum Toxin Type A is administered by intramuscular injection.
For further information see Section 4.2, Posology and method of administration, in the Summary of Product Characteristics.
Disposal
Immediately after treatment of the patient, any residual Botulinum Toxin Type A which may be present in either vial or syringe should be inactivated with dilute hypochlorite solution (1 % available chlorine). Spillage of Botulinum Toxin Type A should be wiped up with an absorbent cloth soaked in dilute hypochlorite solution.
Any unused product or waste material should be disposed of appropriately.
Document name: 184_BTA300_UK
Reason for change: PIQ 3 – replacement of SmPC in the PIL
Document replaced: 179_BTA300_UK
Preparation date: 22/11/2021
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