125 Speywood units, powder for solution for injection,
botulinum toxin type A
1. What Azzalure is and what it is used for
Azzalure contains a substance, botulinum toxin type A, which causes muscles to relax. Azzalure acts on the connection between nerves and muscles and prevents the release of a chemical messenger called acetylcholine from the nerve endings. This prevents the muscles from contracting. This muscle relaxation is temporary and gradually diminishes.
Some people feel mentally ill when they get wrinkles on their faces. Azzalure can be used in adults under 65 years of age for temporary improvement of moderate to pronounced glabella folds (vertical wrinkles between the eyebrows) and wrinkles at the sides of the eyes (crow’s feet).
Botulinum toxin type A contained in Azzalure may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you use Azzalure
Do not use Azzalure
- if you are allergic to Clostridium botulinum toxin type A or any of the other ingredients of this medicine (listed in section 6)
- if you have an infection at the planned injection site
- if you have myasthenia gravis, Eaton-Lambert’s syndrome, or amyotrophic lateral sclerosis ( ALS ).
Warnings and cautions
Tell your doctor before getting an injection of Azzalure:
- if you have any neuromuscular disorders
- if you often have difficulty swallowing food ( dysphagia )
- if you think you often have problems with food or drink getting into the airways so that you have a cough or choking attack
- if you have inflammation at the planned injection site
- if the muscles at the planned injection site are weak
- if you suffer from a bleeding disorder that means you bleed longer than normal, such as hemophilia (hereditary bleeding disorder caused by a lack of coagulation factor )
- if you have had surgery on your face or are likely to undergo facial surgery or other types of surgery soon
- if you have already been given a second injection of botulinum toxin
- if you did not get a significant improvement in your wrinkles after the last treatment with botulinum toxin.
This information will help your doctor make an informed decision about the risks and benefits of your treatment.
In very rare cases, the effect of botulinum toxin may cause muscle weakness at sites other than the injection site.
When botulinum toxin has been used more frequently than every 12 weeks and at higher doses for the treatment of other conditions, antibody formation has been observed in rare cases in patients. The formation of neutralizing antibodies can reduce the effectiveness of treatment.
If you visit a doctor for any reason, make sure you tell them that you have been treated with Azzalure.
Children and young people
Azzalure should not be used by people under 18 years of age.
Other medicines and Azzalure
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Azzalure can affect other medicines that you take or have recently taken, in particular
- antibiotics for infection (eg aminoglycosides such as gentamicin or amikacin) or
- other muscle relaxants.
Azzalure with food and drink
You can be injected with Azzalure either before or after eating or drinking.
Pregnancy and breastfeeding
Azzalure should not be used during pregnancy unless clearly necessary. Azzalure treatment is not recommended if you are breast-feeding. If you are pregnant or planning to become pregnant or breast-feeding, talk to your doctor before using this medicine.
Driving and using machines
You may experience temporary blurred vision or muscle weakness after treatment with Azzalure. If you are affected, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to use Azzalure
Azzalure should only be given by a doctor with appropriate qualifications and knowledge of this treatment, and who has the necessary equipment.
Your doctor will prepare and give the injections. A vial of Azzalure should be used only for you and only during one treatment session.
The recommended dose of Azzalure is
- For glabella folds: 50 units, which are injected with 10 units at each of the 5 injection sites in your forehead in the area above the nose and eyebrows.
- For wrinkles at the side of the eyes (crow’s feet): 60 units injected with 10 units at each of the 6 injection sites, in the area of crow’s feet, at both eyes.
The devices used for different botulinum toxin products are not the same. The Speywood units in Azzalure are not interchangeable with other botulinum toxin products.
The effect of the treatment should be felt within a few days after the injections.
The time period between treatments with Azzalure will be determined by your doctor. You should not be treated more often than every 12 weeks.
Azzalure should not be used in patients under 18 years of age.
4. Possible side effects
Like all medicines, Azzalure can cause side effects, although not everybody gets them.
Seek immediate medical attention if:
- you have difficulty breathing, swallowing, or speaking
- your face swells or your skin turns red or you get itchy, raised rashes. This may mean that you have had an allergic reaction to Azzalure.
Tell your doctor if you notice any of the following side effects:
For glabella folds:
Very common (may affect more than 1 user in 10)
- Redness, swelling, irritation, rash, itching , tingling, pain, discomfort, burning, or bruising at the injection site
Common (may affect up to 1 in 10 people)
- Tired eyes or blurred vision, drooping upper eyelids, swollen eyelids, watery eyes, dry eyes, twitching of the muscles around the eye
- Transient facial paralysis
Uncommon (may affect up to 1 in 100 people)
- Visual disturbance, blurred vision, or double vision
- Itching , rash
- Allergic reactions
Rare ( may affect up to 1 in 1,000 people )
- Itchy, raised rash
- Disorder of the eye movements
For wrinkles on the side of the eyes (crow’s feet):
Common ( may affect up to 1 in 10 people )
- Swollen eyelids
- Bruising, itching, and swelling around the eyes
- Hanging upper eyelids
- Transient facial paralysis
Uncommon (may affect up to 1 in 100 people)
- Dry eyes
These side effects usually appeared within the first week after the injections and did not last long. They were usually mild to moderate in their severity.
In very rare cases, side effects in muscles other than those injected have been reported for botulinum toxin. These include severe muscle weakness, difficulty swallowing due to coughing, and suffocation attacks if swallowed (if food or fluid enters the airways when you try to swallow, you may have respiratory problems such as infection of the lungs). If this happens, consult a doctor immediately.
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Azzalure
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”. The expiration date is the last day of the specified month.
Store Azzalure in a refrigerator (2 -C-8 ºC). Do not freeze.
Your doctor will mix Azzalure into a solution for injection.
Chemical and physical in-use stability has been demonstrated for storage up to 24 hours at 2 ° C to 8 ° C. From a microbiological point of view, unless the reconstitution method excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
6. Contents of the packaging and other information
- The active substance is botulinum toxin type A *. One vial contains 125 Speywood units.
- The other ingredients are human albumin 200 g / l and lactose monohydrate.
* Clostridium botulinum (a bacterium ) toxin A hemagglutinin complex.
The Speywood units in Azzalure are product specific and are not interchangeable with other botulinum toxin products.
What the medicine looks like and the contents of the pack
Azzalure is a powder for solution for injection. It comes in packs of 1 or 2 vials.
Azzalure is a white powder.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Institute of Synthesis Products (IPSEN) AB
Kista Science Tower
164 51 Kista
Ipsen Biopharm Limited
Wrexham Industrial Estate
Ipsen Manufacturing Ireland Limited
Blanchardstown Industrial Park
This leaflet was last modified on 15 May 2019
Other sources of information
If you would like further information or if you would like to see the package leaflet in another format, please contact your local representative:
Galderma Nordic AB
SE-752 28 Uppsala
The following information is intended for healthcare professionals only:
Dosage and route of administration
See the package leaflet under point 3.
Special instructions for disposal and another handling
The instructions for use, handling, and destruction must be followed carefully.
Preparation should be in accordance with good practice, especially with regard to aseptic.
Azzalure must be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection.
According to the dilution table below, the indicated amount of sodium chloride solution for injection 9 mg/ml (0.9%) should be withdrawn into a syringe to obtain a clear reconstituted solution with the following concentration:
|Amount of solvent added (9 mg / ml (0.9%) sodium chloride solution) to a 125 E bottle||Finished dose|
|0.63 ml||10 units per 0.05 ml|
|1.25 ml||10 units per 0.1 ml|
Correct measurement of 0.63 ml or 1.25 ml can be done by using syringes graded in steps of 0.1 ml and 0.01 ml.
RECOMMENDATIONS FOR DESTRUCTION OF CONTAMINATED MATERIAL
Immediately after use and before disposal, all unused reconstituted Azzalure (in the vial or in the syringe) should be inactivated with 2 ml of diluted sodium hypochlorite solution at a concentration of 0.55% or 1% (Dakin’s solution).
Used vials, syringes, and materials should not be emptied but must be disposed of in appropriate containers and disposed of in accordance with local regulations.
RECOMMENDATIONS IN THE EVENT OF ANY ACCIDENT IN THE HANDLING OF BOTULINUM TOXIN
- All spills must be wiped up: either with an absorbent material soaked in sodium hypochlorite solution (bleach) in the case of the powder or with a dry absorbent material in the case of the finished product.
- Contaminated surfaces should be cleaned with an absorbent material soaked in sodium hypochlorite solution (bleach) and then wiped off.
- Follow the instructions above if a vial breaks. Carefully pick up the pieces of glass and dry the product. Be careful not to cut yourself.
- If the product comes in contact with the skin, wash the skin area with sodium hypochlorite solution (bleach) and then rinse thoroughly with plenty of water.
- If the product comes into contact with the eyes, rinse thoroughly with plenty of water or with an eyewash solution.
- If the product comes in contact with a wound (cut or puncture wound), rinse with plenty of water and take appropriate medical measures depending on the dose injected.