Azzalure 10 Speywood Units/0.05ml Powder For Solution For Injection
The following information is intended for healthcare professionals only:
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Azzalure, 10 Speywood Units/0.05 ml, powder for solution for injection
(botulinum toxin type A)
Posology and method of administration:
Please refer to section 3 of the Patient Information Leaflet.
Special precautions for disposal and other handling:
The instructions for use, handling and disposal should be strictly followed.
Reconstitution should be performed in accordance with good practice rules, particularly in the respect of asepsis.
Azzalure has to be reconstituted with a sodium chloride 9 mg/ml (0.9%) solution for injection.
As per the dilution table below, the requested amount of sodium chloride 9 mg/ml (0.9%) solution for injection has to be drawn up into a syringe in order to obtain a reconstituted clear solution at a concentration of 10 U per 0.05 ml.
RECOMMENDATIONS SHOULD ANY INCIDENT
OCCUR DURING THE HANDLING OF BOTULINUM
TOXIN
• Any spills of the product must be wiped up: either using absorbent material impregnated with a solution of sodium hypochlorite (bleach) in case of the powder, or with dry, absorbent material in case of reconstituted product.
• The contaminated surfaces should be cleaned using absorbent material impregnated with a solution of sodium hypochlorite (bleach), then dried.
• If a vial is broken, proceed as mentioned above by carefully collecting the pieces of broken glass and wiping up the product, avoiding any cuts to the skin.
• If the product comes into contact with the skin, wash the affected area with a solution of sodium hypochlorite (bleach) then rinse abundantly with water.
• If product enters into contact with the eyes, rinse thoroughly with plenty of water or with an ophthalmic eyewash solution.
• If product enters into contact with a wound, cut or broken skin, rinse thoroughly with plenty of water and take the appropriate medical steps according to the dose injected.
These instructions for use handling and disposal
should be strictly followed.
The accurate measurement of 0.63 ml can be achieved using 1 ml syringes, graduated in 0.1 ml and 0.01 ml increments.
RECOMMENDATIONS FOR THE DISPOSAL OF CONTAMINATED MATERIALS Immediately after use and prior to disposal, unused reconstituted Azzalure (in the vial or in the syringe) should be inactivated with 2 ml of dilute sodium hypochlorite solution at 0.55 or 1% (Dakin's solution).
Used vials, syringes and materials should not be emptied and must be discarded into appropriate containers and disposed of in accordance with local requirements.
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Amount of solvent added (0.9% sodium chloride solution) to a 125 U vial |
Resulting dose (Units per 0.05 ml) |
|
0.63 ml |
10 U |
A
PACKAGE LEAFLET: INFORMATION FOR THE USER
AZZALIRE
Azzalure, 10 Speywood Units/0.05 ml, powder for solution for injection (botulinum toxin type A)
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.
• 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.
In this leaflet:
1. What Azzalure is and what it is used for
2. What you need to know before you use Azzalure
3. How to use Azzalure
4. Possible side effects
5. How to store Azzalure
6. Contents of the pack and other information
1. WHAT AZZALURE IS AND WHAT IT IS USED FOR
Azzalure contains a substance, botulinum toxin A, which causes muscles to relax. Azzalure acts at the junction between the nerves and muscle to prevent the release of a chemical messenger called acetylcholine from the nerve endings. This prevents muscles from contracting. The muscle relaxation is temporary and gradually wears off.
Some people are distressed when lines appear on their face. Azzalure can be used in adults under 65 years to temporarily improve the appearance of any moderate to severe glabellar lines. These are the vertical frown lines between the eyebrows.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE AZZALURE
Do not have an Azzalure injection if:
• You are allergic to Clostridium botulinum toxin A or any of the other ingredients of this medicine (listed in section 6)
• You have an infection at the proposed site of injection
• You have myasthenia gravis, Eaton Lambert syndrome or amyotrophic lateral sclerosis.
Warnings and precautions
Talk to your doctor before you have the Azzalure injection if:
• You have any neuromuscular disorders
• You often have difficulty swallowing food (dysphagia)
• You find that you often have problems with food or drink getting into your airways causing you to cough or choke
• You have inflammation at the proposed site of injection
• The muscles at the proposed site of injection are weak
• You suffer from a bleeding disorder which means that you continue to bleed for longer than normal, such as haemophilia
• You have had surgery on your face, or are likely to undergo facial or other types of surgery soon
• You have already had other botulinum toxin injections
• You had no significant improvement of your lines after your last treatment with botulinum toxin
This information will help your doctor to make an informed decision about the risk and benefit of your treatment.
Special warnings:
Very rarely, the effect of botulinum toxin may result in muscle weakness away from the site of injection.
When botulinum toxins are used in higher doses to treat other conditions, antibody formation has been noted rarely in patients. The formation of neutralising antibodies may reduce the effectiveness of treatment.
If you are seeing a doctor for any reason, make sure that you tell them that you have been treated with Azzalure.
Other medicines and Azzalure
Azzalure may affect other medicines you are taking, or have recently taken, especially
• Antibiotics for an infection (e.g. aminoglycosides, such as gentamicin or amikacin), or
• Other muscle relaxant drugs.
Always tell your doctor about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.
Azzalure with food and drink
You can have Azzalure injections either before or after eating or drinking.
Pregnancy and breast-feeding
You should not get Azzalure during pregnancy unless clearly necessary. Treatment with Azzalure is not recommended if you are breast-feeding. Tell your doctor if you are pregnant or planning to become pregnant or if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You may experience temporary blurred vision or muscle weakness following treatment with Azzalure. If affected, do not drive or use machinery.
3. HOW TO USE AZZALURE
Azzalure should only be administered by physicians with appropriate qualifications and expertise in this treatment and having the required equipment.
Your doctor will prepare and give the injections. A vial of Azzalure should be used only for you and only for a single treatment session.
The recommended dose of Azzalure is 50 units, injected as 10 units at each of 5 injection sites in your forehead in the area above your nose and eyebrows. The units used for different botulinum toxin products are not the same. Azzalure Speywood units are not interchangeable with other botulinum toxin products. The effect of the treatment on the severity of your glabellar lines should be noticeable in 2 to 3 days.
The interval between treatments with Azzalure will be decided by your doctor. You should not have treatment more often than every 12 weeks.
Azzalure is not suitable for patients under the age of 18. If you receive more Azzalure than you should If you are given more Azzalure than you need then muscles other than the ones that were injected may begin to feel weak. This may not happen straightaway.
If this happens, speak to your doctor immediately.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Azzalure can cause side effects, although not everybody gets them.
Seek urgent medical help if:
• You have difficulties breathing, swallowing or speaking
• Your face swells or skin goes red or you get an itchy lumpy rash. This may mean you are having an allergic reaction to Azzalure
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Tell your doctor if you notice any of the following side effects:
Very common (affects more than 1 user in 10)
• Redness, swelling, irritation, rash, itching, tingling, pain, discomfort, stinging or bruising at the site of the injection
• Headache
Common (affects 1 to 10 users in 100)
• Tired eyes or dim vision, drooping of the upper eyelid, swelling of the eyelid, watering eyes, dry eye, twitching of muscles around the eye
• Facial paralysis
Uncommon (affects 1 to 10 users in 1,000)
• Disturbed, blurred or double vision
• Dizziness
• Itching, rash
• Allergic reactions, see above
• Eye movement disorder
Rare (affects 1 to 10 users in 10,000)
• Itchy and lumpy rash
Usually these side effects have occurred within the first week following injections and did not last long. They were usually mild to moderate in severity.
Very rarely, side effects experienced in muscles other than the ones that were injected have been reported with botulinum toxin. These include excessive muscle weakness, difficulty swallowing, due to coughing and choking when swallowing (if food or liquid enters your airway as you attempt to swallow, respiratory problems can occur, such as lung infections). If this happens, speak to your doctor immediately.
5. HOW TO STORE AZZALURE
Keep Azzalure out of the sight and reach of children.
Do not use Azzalure after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Store Azzalure in a refrigerator (2°C - 8°C). Do not freeze.
Your doctor will dissolve Azzalure into a liquid solution for injection.
Chemical and physical in-use stability has been demonstrated for 24 hours between 2 - 8°C. From a microbiological point of view, unless the method of reconstituting precludes the risks of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Azzalure contains
• The active substance is botulinum toxin type A*,
10 Speywood units/ 0.05 ml. One vial contains 125 Speywood units.
• The other ingredients are human albumin 200g/L and lactose monohydrate.
• Clostridium botulinum (a bacteria) toxin A haemagglutin complex.
The Speywood units of Azzalure are specific to the product and are not interchangeable with other treatments containing botulinum toxin.
What Azzalure looks like and contents of the pack
Azzalure is a powder for solution for injection. It comes in a pack size of 1 or 2 vials.
Azzalure is a white powder.
If you would like any more information, or would like the leaflet in a different format, please contact Galderma (UK) Ltd, tel. +44 (0) 1923 208950.
Distributed by:
Galderma (UK) Ltd Meridien House 69-71 Clarenden Road Watford Herts.
WD17 1DS UK
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system, listed below:
For UK: via the Yellow Card Scheme at:
For Ireland: via HPRA Pharmacovigilance, Earlsfort
Terrace, IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie
By reporting side effects, you can help provide more information on the safety of this medicine.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
For UK: Ipsen Limited, 190 Bath Road, Slough, Berkshire SL1 3XE, United Kingdom.
For Ireland: Ipsen Biopharm Limited, Ash Road, Wrexham Industrial Estate, Wrexham, LL13 9UF, United Kingdom.
Manufacturer:
Ipsen Biopharm Limited Ash Road
Wrexham Industrial Estate
Wrexham
LL13 9UF
This leaflet was last revised in October 2015.
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