300 E powder for injection, solution
Clostridium botulinum toxin type A hemagglutininkomplex
1. What Dysport is and what it is used for
Dysport is a drug that blocks the transmission of nerve impulses to the muscle or sweat glands, thereby reducing the cramp in the muscle or sweat production.
Dysport is used in the treatment of:
- muscle spasms in the arm and shoulder in adults
- muscle spasms in the leg in adults with a pointed foot position
- muscle spasms that lead to the tip of the foot in children over 2 years and thus difficulty walking
- muscle spasms in the arms of children 2 years of age or older with cerebral palsy
- muscle spasms in the neck and neck region in adults
- muscle spasms in the eyelid in adults
- muscle spasms in the face in adults.
Dysport can also be used in the symptom-relieving treatment of excessive sweating in the armpits, which complicates daily activities and is not affected by local treatment.
2. What you need to know before using Dysport
Do not use Dysport
– if you are allergic to clostridium botulinum toxin type A hemagglutinin complex or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor before using Dysport:
- if you have difficulty swallowing or breathing
- if you have problems with nerve impulse transmission, eg myasthenia gravis ( chronic muscle disease)
- if you have developed a permanent muscle shortening (fixed contracture)
- if you have prolonged bleeding, infection, or inflammation at the suggested injection site.
Dysport contains a small amount of human albumin. The risk of transmitting a viral infection cannot be ruled out with absolute certainty when using human blood or blood products.
Contact your doctor immediately or seek medical attention immediately if you have difficulty swallowing, speaking, or breathing.
Other drugs and Dysport
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Other drugs that affect neuromuscular function may potentiate the effect of the active substance in Dysport. Your doctor knows what these medicines are.
Pregnancy, breastfeeding, and fertility
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.
Use during pregnancy is not recommended unless the treatment is considered necessary.
Use during breast-feeding is not recommended.
Driving and using machines
You may experience muscle weakness and visual disturbances such as double vision, impaired visual acuity, and blurred vision after Dysport treatment. Your ability to drive and use machines may be affected.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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 Dysport
Dysport should only be given to you by a doctor who has experience in treating muscle spasms and excessive sweating.
Dose one of Dysport to be given is adapted to the type of treatment and area of use. Your doctor will decide what dose you should receive.
Dysport is given as an injection into the muscle ( intramuscularly ), into the skin (intradermally), or under the skin ( subcutaneously ) after dilution.
The syringe with Dysport should be used only for you and only for one treatment.
If you use more Dysport than you should
If you get more Dysport than you need, muscles other than those injected may feel weak. Too high a dose can also cause muscle paralysis. This may not happen immediately. If this happens, consult a doctor immediately. Seek emergency medical attention if you have difficulty breathing, swallowing, or speaking.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you have difficulty swallowing or speaking or if you have difficulty breathing with or without swelling of the face, lips, tongue, and/or throat, redness of the skin, or itchy skin rash ( hives ). This may mean that you have had an allergic reaction to Dysport.
Side effects are generally for all indications:
Common (may affect up to 1 in 10 people): Local muscle weakness, weakness, fatigue, flu-like illness, pain/soreness at the injection site.
Uncommon (may affect up to 1 in 100 people): Itching.
Rare (may affect up to 1 in 1,000 people): Loss of muscle mass, rash.
Has been reported (occurs in an unknown number of users): Loss of sensation.
Side effects are in the treatment of muscle spasms in the arm and shoulder in adults:
Common (may affect up to 1 in 10 people): Muscle weakness; pain in muscles and bones; pain, redness, or swelling at the injection site; impotence; fatigue; flu-like illness; pain in hands and fingers.
Uncommon (may affect up to 1 in 100 people ): Difficulty swallowing.
Side effects are in the treatment of muscle spasms in the leg in adults:
Common (may affect up to 1 in 10 people ): Difficulty swallowing; muscle weakness; muscle pain; impotence; fatigue; flu-like illness; pain, bruising, rash or itching at the injection site; case.
Side effects are in the treatment of muscle spasms that lead to the tip of the foot in children who are 2 years or older:
Common (may affect up to 1 in 10 people): Muscle pain; general muscle weakness; urinary incontinence; flu-like illness; pain, redness or bruising at the injection site; abnormal gait; fatigue; case.
Uncommon (may affect up to 1 in 100 people ): Weakness, difficulty swallowing, local muscle weakness.
Side effects include treatment of muscle spasms in the arms of children 2 years of age or older with cerebral palsy:
Common (may affect up to 1 in 10 people): Local muscle weakness, pain in hands and fingers, flu-like illness, weakness, fatigue, bruising at the injection site, skin rash.
Uncommon (may affect up to 1 in 100 people): Muscle pain, injection site eczema, injection site pain, injection site rash, injection site swelling, general muscle weakness.
Has been reported (occurs in an unknown number of users): Difficulty swallowing.
Side effects are in the treatment of muscle spasms in the arms and legs in children 2 years or older with cerebral palsy:
No specific side effects have been seen as Dysport is given in both arms and legs at the same treatment time, compared to those expected with separate treatment in the arm and leg, respectively.
Side effects in the treatment of muscle spasms in the neck and neck region in adults:
Very common (may affect more than 1 user in 10): Difficulty swallowing, dry mouth muscle weakness.
Common (may affect up to 1 in 10 people): Headache, dizziness, weakened facial muscles, blurred vision, impaired visual acuity, voice changes, difficulty breathing, neck pain, pain and stiffness in muscles and bones, pain in arms and legs.
Uncommon (may affect up to 1 in 100 people): Double vision, drooping eyelids, nausea, muscle wasting, impaired jaw function.
Rare (may affect up to 1 in 1,000 people): Aspiration (difficulty inhaling).
Side effects are in the treatment of muscle spasms in the eyelid and face:
Very common (may affect more than 1 user in 10): droopy eyelids.
Common (may affect up to 1 in 10 people): Weak facial muscles, double vision, dry eyes, increased tear flow, eyelid swelling.
Uncommon (may affect up to 1 in 100 people): Facial paralysis.
Rare (may affect up to 1 in 1,000 people ): Eye muscle paralysis, inward folding of the eyelid edge.
Side effects of treating excessive sweating:
Common (may affect up to 1 in 10 people): Pain in shoulders, upper arm, and neck, muscle pain in shoulders and calves, difficulty breathing, increased sweating in other skin areas.
Uncommon (may affect up to 1 in 100 people): Dizziness, headache, numbness, and tingling in the arms and legs, nosebleeds, redness, involuntary muscle spasms in the eyelids.
Rare (may affect up to 1 in 1,000 people): Allergic reactions such as rash.
5. How to store Dysport
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 carton and label after EXP. The expiration date is the last day of the specified month.
Injection in unopened packaging should be stored in a refrigerator (2 ° C-8 ° C). Do not freeze. These instructions also apply if you keep the medicine at home.
It is recommended that the reconstituted solution be used immediately, but it can be stored for up to 24 hours in a refrigerator (2 ° C-8 ° C).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is Clostridium botulinum toxin type A hemagglutinin complex 300 units (E). The listed units for Dysport are specific and can not be transferred to other botulinum products.
- The other ingredients are human albumin and lactose
What the medicine looks like and the contents of the pack
Dysport injection substance is a white lyophilized powder and provided in a vial of Type I colorless glass sealed with a rubber stopper and aluminum shell.
Packs of 1 x 1 and 2 x 1 vial.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Institute of Synthesis Products (IPSEN) AB
Kista Science Tower
Färögatan 33
164 51 Kista
Tel: 08-451 60 00
info.se@ipsen.com
Manufacturer:
Ipsen Biopharm Limited
Ash Road, Wrexham Industrial Estate
Wrexham LL13 9UF, UK and Northern Ireland
Ipsen Manufacturing Ireland Limited
Blanchardstown Industrial Park
Blanchardstown
Dublin 15
Ireland