くすりのしおり

Injection
Revised: 3/2018

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
REPLAGAL FOR INTRAVENOUS DRIP INFUSION 3.5mg
 Active ingredient:
Agalsidase alfa (genetical recombination)
 Dosage form:
Injection
 Print on wrapping:

Effects of this medicine

This medicine replaces the human enzyme alfa-galactosidase.
It is usually used for treatment of Fabry disease.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
  • If you are pregnant or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • In general, this medicine is administered by intravenous drip infusion every two weeks.
  • The treatment period with this medicine depends on your symptoms.

Precautions while taking this medicine

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include fever, chills, fatigability, nausea, pain of the extremities, feeling hot and breathing difficulty. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • breathing difficulty, hives, systemic redness with itch [anaphylaxis]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • If you become unwell during an infusion, you should tell your doctor immediately.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.