Description
AZZALURE, 125 Speywood units, powder for solution for injection
Botulinum toxin type A
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.
· If you experience any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.
What does this leaflet contain?
1. What is AZZALURE, 125 Speywood units, powder for solution for injection and what is it used for?
2. What you need to know before you use AZZALURE, 125 units Speywood, powder for solution for injection?
3. How to use AZZALURE, 125 Speywood units, powder for solution for injection?
4. What are the possible side effects?
5. How to store AZZALURE, 125 Speywood units, powder for solution for injection?
6. Package contents and other information.
1. WHAT IS AZZALURE, 125 Speywood units, powder for solution for injection AND WHAT IS IT USED FOR? 
Pharmacotherapeutic group: other peripherally acting muscle relaxants – ATC code: M03AX01.
Azzalure contains a substance, botulinum toxin type A, which causes muscle relaxation. Azzalure acts at the junction between nerves and muscles, preventing the release of a chemical “messenger” called acetylcholine from nerve endings, which inhibits muscle contraction. This muscle relaxation is temporary and gradually disappears.
Some people are very sensitive to the appearance of wrinkles on their face. Azzalure can be used in adults under 65 to temporarily correct moderate to severe glabellar lines (vertical lines between the eyebrows caused by frowning) and lateral canthal lines (crow’s feet).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE AZZALURE, 125 Speywood units, powder for solution for injection?
Do not have an injection of AZZALURE, 125 units Speywood, powder for solution for injection if:
· you are allergic (hypersensitive) to botulinum toxin type A ( Clostridium botulinum ) or to any of the other ingredients of this medicine, listed in section 6,
· you have an infection at the proposed injection site,
· you have myasthenia gravis or Lambert-Eaton syndrome or amyotrophic lateral sclerosis.
Tell your doctor before injecting Azzalure if:
· you suffer from a neuromuscular disorder,
· you have difficulty swallowing food (dysphagia),
· you often swallow food and drinks the wrong way, which causes you to cough or choke,
· you have inflammation at the proposed injection site,
· the muscles at the proposed injection site are weak,
· you have a clotting disorder, which means you bleed for longer than normal, such as haemophilia (an inherited bleeding disorder caused by an abnormality in a blood clotting factor),
· you have had facial surgery or are about to have facial surgery or another type of surgery,
· you have recently had botulinum toxin injections,
· your wrinkles have not improved significantly after your last botulinum toxin treatment.
This information will help your doctor make the best decision about the potential risks and benefits of treatment for you.
When you are treated with Azzalure, your eyes may become dry. Azzalure may cause a decrease in blinking frequency or a decrease in tear production, which could damage the surface of your eyes.
Special warnings
Very rarely, the effect of botulinum toxin can cause muscle weakness away from the injection site.
When using botulinum toxins with intervals between treatments of less than 12 weeks or at higher doses to treat other pathologies, the formation of neutralizing antibodies has been observed in rare cases, which may reduce the effectiveness of the treatment.
If you see a doctor for any reason, be sure to tell them that you have received Azzalure injections.
Children and adolescents
AZZALURE is not indicated for patients under 18 years of age.
Other medicines and AZZALURE, 125 units Speywood, powder for solution for injection
Tell your doctor if you are taking, have recently taken or might take any other medicines as Azzalure may interfere with other medicines, including:
· antibiotics, taken to treat an infection (for example, aminoglycosides, such as gentamicin or amikacin) or
· other muscle relaxant drugs.
AZZALURE, 125 units Speywood, powder for solution for injection with food and drink
Azzalure injections can be administered regardless of food or drink intake.
Azzalure should not be used during pregnancy.
Treatment with Azzalure is not recommended if you are breastfeeding.
If you are pregnant, planning to become pregnant, or breastfeeding, ask your doctor for advice before taking any medication.
Driving vehicles and using machines
Treatment with Azzalure may cause temporary problems such as blurred vision, muscle weakness, or general weakness. It is therefore not recommended to drive or operate machinery.
AZZALURE, 125 units Speywood, powder for solution for injection contains
Not applicable.
3. HOW TO USE AZZALURE, 125 Speywood units, powder for solution for injection?
Azzalure should only be administered by qualified physicians who are experienced in the use of this treatment and have the necessary equipment.
The injections will be prepared and administered by your doctor. One vial of Azzalure should only be used to treat one patient, during a single session.
The recommended dose of Azzalure is:
· For glabellar lines, 50 units, that is, one injection of 10 units in each of the 5 injection sites on the forehead, in the area above your nose, between your eyebrows,
· For lateral canthal wrinkles, 60 units, i.e. an injection of 10 units in each of the 6 injection sites in the crow’s feet areas.
The units used for different botulinum toxin products are not the same. Azzalure’s Speywood units are specific to this product and are not interchangeable with other botulinum toxin preparations.
The effect of the treatment can be seen a few days after the injection.
The time interval between treatment sessions will be determined by your doctor, but should be a minimum of 12 weeks.
Use in children and adolescents
Azzalure is not indicated for patients under 18 years of age.
If you receive more AZZALURE, 125 units Speywood, powder for solution for injection than you should:
If you receive more Azzalure than you need, muscles other than the injected ones may begin to weaken. This does not always happen immediately. If this happens to you, tell your doctor as soon as possible.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medication can cause side effects, although not everybody gets them.
Consult a doctor urgently if:
· You have difficulty breathing, swallowing or speaking,
· Your face swells, your skin turns red, or you have an itchy, hive-like rash. This may mean you are having an allergic reaction to Azzalure.
Tell your doctor if you experience any of the following side effects:
For glabellar lines
Very common (seen in more than 1 in 10 users)
· Redness, swelling, irritation, rash, itching, tingling, pain, discomfort, stinging or bruising at the injection site.
· Headaches.
Common (affects 1 to 10 users in 100)
· Tired eyes or decreased vision, drooping of the upper eyelid, swelling of the eyelid, watering, dry eye, muscle twitching (involuntary contractions) of the muscles around the eyes.
· Temporary facial paralysis.
Uncommon (affects 1 to 10 users in 1,000)
· Visual disturbances, blurred vision, diplopia (double vision).
· Dizziness.
· Itching, rash.
· Allergic reactions.
Rare (affects 1 to 10 users in 10,000)
· Itchy, hive-like rash.
· Eye movement disorders.
Frequency not known (cannot be estimated from the available data)
· Numbness.
· Muscle atrophy.
· Generalized weakness.
· Fatigue.
· Flu-like symptoms.
For lateral canthal wrinkles
Common (affects 1 to 10 users in 100)
· Headaches.
· Swelling of the eyelid.
· Bruising, itching, swelling around the eyes.
· Drooping of the upper eyelid.
· Temporary facial paralysis.
Uncommon (affects 1 to 10 users in 1,000)
· Dry eyes.
Frequency not known (cannot be estimated from the available data)
· Allergic reactions.
· Numbness.
· Muscle atrophy.
· Generalized weakness.
· Fatigue.
· Flu-like symptoms.
These reactions usually occur within the first week after the injection and are transient. They are usually mild or moderate in intensity.
Very rarely, side effects have been observed in muscles other than those into which the injection was given. These side effects include excessive muscle weakness, difficulty swallowing due to coughing, or a choking sensation when swallowing (if you swallow food or liquid the wrong way, you risk breathing problems or a lung infection). If this happens to you, you should consult your doctor immediately.
Reporting of side effects
If you experience 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: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers – Website: www.signalement-sante.gouv.fr .
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE AZZALURE, 125 units Speywood, powder for solution for injection?
Keep out of sight and reach of children.
Your doctor should not use this medicine after the expiry date shown on the label. The expiry date refers to the last day of that month.
Store in the refrigerator (between 2°C and 8°C). Do not freeze.
Your doctor dissolves Azzalure in a liquid for injection.
Physical and chemical in-use stability has been demonstrated for 24 hours at 2°C to 8°C. From a microbiological point of view, unless the method of reconstitution precludes the risk 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 PACKAGE AND OTHER INFORMATION
What AZZALURE, 125 units Speywood, powder for solution for injection contains
· The active substance is:
Botulinum toxin type A*. Each vial contains 125 Speywood units.
· The other ingredients are: human albumin 200 g/L and lactose monohydrate.
* Clostridium botulinum (a bacterium) toxin A complex – hemagglutinin.
Azzalure Speywood units are specific to this specialty and are not interchangeable with other botulinum toxin preparations.
What AZZALURE, 125 Speywood units, powder for solution for injection looks like and contents of the outer packaging
Azzalure is a powder for solution for injection. Boxes of 1 or 2 vials.
Azzalure is a white powder.
Marketing Authorisation Holder
65 QUAI GEORGES GORSE
92100 BOULOGNE-BILLANCOURT
Marketing Authorization Operator
EUROPLAZA TOWER
20 AVENUE ANDRE PROTHIN
LA DEFENSE 4
92927 LA DEFENSE CEDEX
IPSEN MANUFACTURING IRELAND LIMITED
BLANCHARDSTOWN INDUSTRIAL PARK
BLANCHARDSTOWN
DUBLIN 15
IRELAND
Names of the medicine in the member states of the European Economic Area
This medicine is authorized in the member states of the European Economic Area under the following names: In accordance with current regulations.
[To be completed later by the holder]
The last date this notice was revised is:
[to be completed later by the holder]
< {MM/YYYY}>< {month YYYY}.>
Not applicable.
Detailed information on this medicine is available on the ANSM (France) website.
The following information is intended for healthcare professionals only.
Dosage and method of administration:
See section 3 of the user information leaflet.
Special precautions for disposal and handling:
Instructions for use, handling and disposal must be strictly followed.
Reconstitution must be carried out in accordance with good practice rules, particularly regarding aseptic conditions.
Azzalure should be reconstituted with sodium chloride 9 mg/ml (0.9%) solution for injection.
As indicated in the dilution table below, the required volume of sodium chloride 9 mg/ml (0.9%) solution for injection should be withdrawn using a syringe to obtain a clear, colorless reconstituted solution having the following concentration:
|
Volume of solvent to be used (0.9% sodium chloride solution) for one vial containing 125 U |
Concentration obtained |
|
0.63 ml |
10 U per 0.05 ml |
|
1.25 ml |
10 U per 0.1 ml |
To accurately measure the volume to be used for reconstitution (0.63 ml or 1.25 ml), syringes with 0.1 ml and 0.01 ml graduations should be used.
RECOMMENDATIONS FOR THE DISPOSAL OF CONTAMINATED MATERIAL
Immediately after use and before disposal, unused reconstituted Azzalure solution (in the vial and/or syringe) must be inactivated by adding 2 ml of a dilute 0.55 or 1% sodium hypochlorite solution (Dakin’s solution).
Used bottles, syringes and materials must not be emptied and must be placed in suitable containers for disposal in accordance with local regulations.
RECOMMENDATIONS IN THE EVENT OF AN INCIDENT WHEN HANDLING BOTULINUM TOXIN
· Any spillage must be wiped up: with absorbent material soaked in a sodium hypochlorite solution (bleach) in the case of a freeze-dried product, or with dry absorbent material in the case of a reconstituted product.
· Contaminated surfaces will be cleaned with absorbent material, soaked in sodium hypochlorite (bleach), then dried.
· In case of bottle breakage, proceed as indicated above, carefully collect the glass particles and wipe off the product, avoiding skin cuts.
· In case of skin contact, wash the affected area with sodium hypochlorite solution (bleach) then rinse thoroughly with water.
· In case of contact with eyes, rinse thoroughly with water or ophthalmic eye wash solution.
· In case of contact of the product with a wound, cut or puncture, rinse thoroughly with water and take appropriate medical measures according to the dose injected.
These instructions for use, handling and disposal must be strictly followed.
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