Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
Alglucosidase alfa, Quantity: 52.5 mg
Sanofi-Aventis Australia Pty Ltd
Alglucosidase alfa
Injection, powder for
Excipient Ingredients: monobasic sodium phosphate monohydrate; polysorbate 80; mannitol; nitrogen
Intravenous
50 mg / 10 mL
(S4) Prescription Only Medicine
MYOZYME (alglucosidase alfa-rch) is indicated for the long-term treatment of patients with a confirmed diagnosis of Pompe disease (acid alfa-glucosidase deficiency).
Visual Identification: White to off-white lyophilised cake of powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2008-03-14
MYOZYME ® [MY-OH-ZIME] _Alglucosidase alfa-rch [al-glue-co-SIDE-aze al-fa R.C.H] 50 mg/10 mL, Powder for Concentrate for_ _Solution for Infusion_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Myozyme. It does not contain all the available information about Myozyme. It does not take the place of talking to your treating physician or a trained health care professional. All medicines have risks and benefits. Your treating physician has weighed the risks of you or your child having Myozyme against the benefits they expect it will have. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR NURSE. KEEP THIS LEAFLET. You may need to read it again. WHAT IT IS USED FOR _WHAT MYOZYME IS USED FOR_ Myozyme is used to treat Pompe disease, a rare genetic disease in which the level of an enzyme called acid alfa-glucosidase is missing or is lower than in healthy individuals. Myozyme is used as a replacement to the lack of or low levels of the enzyme. Myozyme contains the active ingredient alglucosidase alfa- rch. Alglucosidase alfa-rch is a type of protein. Myozyme is available only with a doctor's prescription. Only the treating physician can start the treatment and supervise the ongoing treatment. Myozyme is to be given only to the person for whom it has been prescribed. _HOW IT WORKS_ Patients with Pompe disease do not produce enough of their own enzyme, acid alfa-glucosidase. The reduced acid alfa-glucosidase activity in patients results in the build up of glycogen in many parts of the body. Myozyme is an enzyme replacement therapy that is intended to restore a level of enzyme activity sufficient to remove the accumulated glycogen and to prevent further accumulation. Pompe disease has been described under 2 forms: early-onset and late- onset. Your physician is in the best position to determine the risks and benefits of treatment with Myozyme and he will discuss it with you or your child. ASK YOUR TREATING PHYSICIAN IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS Prečítajte si celý dokument
Property of the Sanofi group - strictly confidential myo-ccdsv9-piv4-06aug20 Page 1 AUSTRALIAN PRODUCT INFORMATION – MYOZYME (ALGLUCOSIDASE ALFA) POWDER FOR SOLUTION FOR INFUSION 1 NAME OF THE MEDICINE Alglucosidase alfa. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 50 mg vial contains 52.5 mg alglucosidase alfa. For the full list of excipients, see section 6.1 - List of excipients 3 PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. Following reconstitution as directed, each vial contains 10.5 mL reconstituted solution and a total extractable volume of 10 mL at 5.0 mg/mL alglucosidase alfa. MYOZYME does not contain preservatives. Each vial is for single use only. Each reconstituted vial must be diluted prior to administration in 0.9% sodium chloride for injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MYOZYME is indicated for the long-term treatment of patients with a confirmed diagnosis of Pompe disease (acid alfa-glucosidase deficiency). 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE The recommended dosage regimen of MYOZYME is 20 mg/kg of body weight administered once every 2 weeks as an intravenous infusion. Property of the Sanofi group - strictly confidential myo-ccdsv9-piv4-06aug20 Page 2 _ELDERLY POPULATION _ Clinical studies did not include any subjects aged 65 years and older. It is not known whether they respond differently than younger subjects. _PAEDIATRIC POPULATION _ There is no evidence for special considerations when MYOZYME is administered to paediatric patients of all ages. METHOD OF ADMINISTRATION Each reconstituted vial must be diluted prior to administration in 0.9% sodium chloride for injection. For instructions on reconstitution and dilution of the medicine before administration, see section Section 6.6 - Special precautions for disposal and other handling. Infusions should be administered incrementally. MYOZYME should be administered at an initial infusion rate of no more than 1 mg/kg/hr. The infusion rate may be increased by 2 mg/kg/hr every 30 minutes, a Prečítajte si celý dokument