Λογότυπο www.galinos.gr Beta
 

Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
Όνομα χρήστη
Συνθηματικό
Εικονίδιο Είσοδος χρήστη
Εικονίδιο Δωρεάν εγγραφή
Εικονίδιο Ανανέωση συνθηματικού

Ακολουθήστε μας Λογότυπο Facebook Λογότυπο Twitter

Αναζήτηση σε 63811 καταχωρήσεις
Εικονίδιο αναζήτησης

Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Replagal 1mg/ml concentrate for solution for infusion (2012)

Εκδότης

Εκδότης Shire Human Genetic Therapies
Διεύθυνση Hampshire International Business Park, Crockford Lane, Basingstoke, Hampshire, RG24 8EP, UK
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

Replagal 1 mg/ml concentrate for solution for infusion.

Qualitative and quantitative composition

1 ml of concentrate for solution for infusion contains 1 mg of agalsidase alfa. Each vial of 1 ml of ...

Pharmaceutical form

Concentrate for solution for infusion. A clear and colourless solution.

Therapeutic indications

Replagal is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis ...

Posology and method of administration

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

Contraindications

Hypersensitivity to the active substance or any of the excipients.

Special warnings and precautions for use

Idiosyncratic infusion related reactions 13.7% of adult patients treated with Replagal in clinical trials ...

Interaction with other medicinal products and other forms of interaction

Replagal should not be co-administered with chloroquine, amiodarone, benoquin or gentamicin since these ...

Fertility, pregnancy and lactation

Pregnancy Very limited clinical data on pregnancies exposed to Replagal (n=4) have shown no adverse effects ...

Effects on ability to drive and use machines

Replagal has no or negligible influence on the ability to drive and use machines.

Undesirable effects

The most commonly reported undesirable effects were infusion associated reactions, which occurred in ...

Overdose

No case of overdose has been reported.

Pharmacodynamic properties

Pharmacotherapeutic group: Other alimentary tract and metabolism products Enzymes ATC code: A16AB03 ...

Pharmacokinetic properties

Single doses ranging from 0.007 0.2 mg enzyme per kg body weight were administered to adult male patients ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity. Genotoxic ...

List of excipients

Sodium phosphate monobasic, monohydrate Polysorbate 20 Sodium chloride Sodium hydroxide Water for injections ...

Incompatibilities

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

Shelf life

2 years Chemical and physical in use stability has been demonstrated for 24 hours at 25°C. From a microbiological ...

Special precautions for storage

Store in a refrigerator (2°C – 8°C).

Nature and contents of container

1 ml of concentrate for solution for infusion in a 3 ml vial (Type I glass) with a stopper (fluoro-resin ...

Special precautions for disposal and other handling

Calculate the dose and number of Replagal vials needed. Dilute the total volume of Replagal concentrate ...

Marketing authorization holder

Shire Human Genetic Therapies AB Svärdvägen 11 D 182 33 Danderyd, Sweden Tel: +46 8 5449 6400 Fax: +46 ...

Marketing authorization number(s)

EU/1/01/189/001-006

Date of first authorization / renewal of the authorization

Date of first authorisation: 03/08/2001 Date of last renewal: 03/08/2006

Date of revision of the text

December 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.