Myozyme 50 mg, powder for concentrate for solution for infusion (2011)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Genzyme Therapeutics |
|---|---|
| Διεύθυνση | 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford, Oxfordshire, OX4 2SU |
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Interaction with other medicinal products and other forms of interaction
No interactions studies have been performed. Because it is a recombinant human protein, alglucosidase alfa is an unlikely candidate for cytochrome P450 mediated drug-drug interactions.
Name of the medicinal product
Myozyme 50 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
One vial contains 50 mg of alglucosidase alfa. After reconstitution, the solution contains 5 mg of alglucosidase alfa* per ml and after dilution, the concentration varies from 0.5 mg to 4 mg/ml. *Human ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of alglucosidase alfa in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Myozyme ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Because dizziness has been reported as an infusion associated reaction, this may affect the ability to drive and ...
Undesirable effects
Infantile-onset Pompe disease In clinical trials, 39 infantile-onset patients were treated with Myozyme for more than three years (168 weeks with a median of 121 weeks; see section 5.1). Adverse reactions ...
Contraindications
Life threatening hypersensitivity (anaphylactic reaction) to the active substance or to any of the excipients, when rechallenge was unsuccessful (see sections 4.4 and 4.8).
Therapeutic indications
Myozyme is indicated for long-term enzyme replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid α-glucosidase deficiency). Myozyme is indicated in adults and paediatric ...
Posology and method of administration
Myozyme treatment should be supervised by a physician experienced in the management of patients with Pompe disease or other inherited metabolic or neuromuscular diseases. Posology The recommended dose ...
Pharmaceutical form
Powder for concentrate for solution for infusion. White to off-white powder.
Special warnings and precautions for use
Hypersensitivity/Anaphylactic reactions Serious and life-threatening anaphylactic reactions, including anaphylactic shock, have been reported in infantile- and late-onset patients during Myozyme infusions ...
Date of revision of the text
11-2011
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Special precautions for storage
Store in a refrigerator (2°C 8°C). For storage conditions of the diluted medicinal product, see section 6.3.
Special precautions for disposal and other handling
Myozyme has to be reconstituted with water for injections, then diluted with sodium chloride 9 mg/ml (0.9%) solution for injection and then administered by intravenous infusion. Reconstitution and dilution ...
Marketing authorization holder
Genzyme Europe B.V. Gooimeer 10 NL-1411 DD Naarden The Netherlands
Pharmacokinetic properties
Infantile-onset Pompe disease In a pivotal trial including 18 patients, the pharmacokinetics of alglucosidase alfa were evaluated in 15 patients with infantile-onset Pompe disease (all less than 6 months ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 29 March 2006 Date of latest renewal: 29 March 2011
Nature and contents of container
50 mg of powder in a vial (Type 1 glass) with a stopper (siliconised butyl) and a seal (aluminium) with a flip-off cap (plastic). Pack sizes of 1, 10 or 25 vials. Not all pack sizes may be marketed.
Pharmacodynamic properties
Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes ATC code: A16AB07 Pompe disease Pompe disease is a rare, progressive and fatal metabolic myopathy with an estimated global ...
Preclinical safety data
Preclinical data reveal no special hazards for humans based on studies of safety pharmacology, single and repeat dose toxicity. No significant adverse findings on embryofoetal development were observed ...
Overdose
There is no experience with overdose of alglucosidase alfa. In clinical studies doses up to 40 mg/kg body weight were used.
Marketing authorization number(s)
EU/1/06/333/001-003
List of excipients
Mannitol Sodium dihydrogen phosphate monohydrate Disodium phosphate heptahydrate Polysorbate 80
Shelf life
2 years After dilution, an immediate use is recommended. However, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C when stored under protection from light.