What Dysport is used for and how to use it
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Dysport - Consumer Medicine Information

Manufacture: Galdorma Laboratories
Country: Canada
Condition: Blepharospasm, Spasmodic Torticollis (Cervical Dystonia)
Class: Muscle relaxants
Form: Intramuscular (IM), Powder
Ingredients: abobotulinumtoxinA, human serum albumin, lactose monohydrate

About This Medication

What the Medication is Used For

DYSPORT is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients < 65 years of age.

What it Does

Dysport is a drug that temporarily reduces movement of certain upper facial muscles that cause wrinkles. Some patients see results as soon as 24 hours with a median time to onset of three days.

When it Should not be Used

It should not be used if:

  • you are allergic or sensitive to any of the ingredients
  • you have an infection in the muscles where it would normally be injected
  • you are allergic to cow´s milk protein
  • you have any muscle disorders in other parts of your body, including myasthenia gravis, Eaton Lambert Syndrome or amyotrophic lateral sclerosis

What the Medicinal Ingredient Is

abobotulinumtoxinA

What the Important Nonmedicinal Ingredients Are

Human serum albumin and lactose monohydrate

What Dosage Forms It Comes In

DYSPORT is supplied in a single-use, sterile 300 Unit vial.

Warnings and Precautions

BEFORE you use DYSPORT talk to your doctor or pharmacist if:

  • you have myasthenia gravis or Eaton Lambert Syndrome, amyotrophic lateral sclerosis or another muscle disorder
  • you are allergic or sensitive to any botulinum toxin product
  • you have an infection at the proposed injection site
  • you are scheduled to have surgery using a general anesthetic
  • you are taking or are likely to take antibiotics, especially aminoglycoside antibiotics
  • you are pregnant or become pregnant while taking this drug.
  • you are nursing. It is not known whether this drug is excreted in human milk.

DYSPORT is for intramuscular use only.

DYSPORT should only be given by a physician with the appropriate qualifications and experience in the treatment and use of DYSPORT.

Seek immediate medical attention if swallowing, speech or respiratory problems arise.

Tell your doctor if you experience any difficulties in swallowing food while on DYSPORT, as it could be related to the dosage. Difficulty in swallowing food, ranging from very mild to severe, can persist for 2 – 3 weeks after injection, or longer.

Tell your doctor if you are taking other medicines, including those you have bought at your pharmacy, supermarket or health food shop.

Interactions With This Medication

The effect of DYSPORT may be increased by aminoglycoside antibiotics (e.g., streptomycin, tobramycin, neomycin, gentamicin, netilmicin, kanamycin, amikacin), spectinomycin, polymyxins, tetracyclines, lincomycin or any other drugs that interfere with neuromuscular transmission.

Proper Use of This Medication

Usual Dose

DYSPORT can only be used by health care professionals experienced in the application of Botulinum toxin.

The optimum dosage and number of injection sites in the treated muscle will be chosen by your doctor.

Overdose

Overdose with DYSPORT is a relative term that can reflect undesired aesthetic effect. Symptoms of overdose for this product, as for all botulinum toxins, are related to the dose, the condition being treated and susceptibility of the patient. Symptoms are not apparent immediately after the injection and may include general weakness, drooping eyelid, double vision, swallowing and speech difficulties, and pneumonia.

In case you feel symptoms of overdose please seek medical emergency services immediately or ask your relatives to do so, and have yourself admitted to hospital. Medical supervision for up to several days and assisted ventilation may be necessary.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Side Effects and What to do About Them

The most commonly reported side effects (≥ 3%) were sore throat, headache, injection site pain, upper respiratory infection, or sinus infection.

The following additional side effects have been reported with Dysport:

  • Eyelid ptosis

This is not a complete list of side effects. For any unexpected effects while taking DYSPORT, contact your doctor or pharmacist.

How to Store It

Keep out of the reach and sight of children.

DYSPORT must be stored under refrigeration at 2 – 8°C. Protect from light. Once reconstituted, it can be stored under refrigeration at 2 – 8°C for up to 24 hours. Do not freeze after reconstitution.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701D
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada website at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of the side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals can be found at:
http://www.galderma.ca
or by contacting the sponsor, Galderma Canada Inc. at: 1-800-467-2081