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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Myozyme 50 mg, powder for concentrate for solution for infusion (2011)

Εκδότης

Εκδότης Genzyme Therapeutics
Διεύθυνση 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford, Oxfordshire, OX4 2SU
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

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 ...

Pharmaceutical form

Powder for concentrate for solution for infusion. White to off-white powder.

Therapeutic indications

Myozyme is indicated for long-term enzyme replacement therapy (ERT) in patients with a confirmed diagnosis ...

Posology and method of administration

Myozyme treatment should be supervised by a physician experienced in the management of patients with ...

Contraindications

Life threatening hypersensitivity (anaphylactic reaction) to the active substance or to any of the excipients, ...

Special warnings and precautions for use

Hypersensitivity/Anaphylactic reactions Serious and life-threatening anaphylactic reactions, including ...

Interaction with other medicinal products and other forms of interaction

No interactions studies have been performed. Because it is a recombinant human protein, alglucosidase ...

Fertility, pregnancy and lactation

Pregnancy There are no data from the use of alglucosidase alfa in pregnant women. Studies in animals ...

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 ...

Undesirable effects

Infantile-onset Pompe disease In clinical trials, 39 infantile-onset patients were treated with Myozyme ...

Overdose

There is no experience with overdose of alglucosidase alfa. In clinical studies doses up to 40 mg/kg ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes ATC code: A16AB07 ...

Pharmacokinetic properties

Infantile-onset Pompe disease In a pivotal trial including 18 patients, the pharmacokinetics of alglucosidase ...

Preclinical safety data

Preclinical data reveal no special hazards for humans based on studies of safety pharmacology, single ...

List of excipients

Mannitol Sodium dihydrogen phosphate monohydrate Disodium phosphate heptahydrate Polysorbate 80

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal ...

Shelf life

2 years After dilution, an immediate use is recommended. However, chemical and physical in-use stability ...

Special precautions for storage

Store in a refrigerator (2°C 8°C). For storage conditions of the diluted medicinal product, see section ...

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 ...

Special precautions for disposal and other handling

Myozyme has to be reconstituted with water for injections, then diluted with sodium chloride 9 mg/ml ...

Marketing authorization holder

Genzyme Europe B.V. Gooimeer 10 NL-1411 DD Naarden The Netherlands

Marketing authorization number(s)

EU/1/06/333/001-003

Date of first authorization / renewal of the authorization

Date of first authorisation: 29 March 2006 Date of latest renewal: 29 March 2011

Date of revision of the text

11-2011
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.