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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

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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Haemonine 500 / Haemonine 1000 (2012)

Εκδότης

Εκδότης Biotest (UK) Ltd
Διεύθυνση 28 Monkspath Business Park,, Highlands Road, Shirley, Solihull, B90 4NZ, 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

Haemonine® 500. Haemonine® 1000. Powder and solvent for solution for injection.

Qualitative and quantitative composition

Human plasma derived coagulation factor IX; Haemonine® 500 / Haemonine® 1000 is presented as a powder ...

Pharmaceutical form

Powder and solvent for solution for injection.

Therapeutic indications

Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). ...

Posology and method of administration

Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. ...

Contraindications

Hypersensitivity to the active substance, to any of the excipients or to heparin.

Special warnings and precautions for use

As with any intravenous protein product, allergic type hypersensitivity reactions are possible. The product ...

Interaction with other medicinal products and other forms of interaction

No interactions of human coagulation factor IX products with other medicinal products are known.

Pregnancy and lactation

Animal reproduction studies have not been conducted with factor IX. Based on the rare occurrence of haemophilia ...

Effects on ability to drive and use machines

No effects on ability to drive and use machines have been observed.

Undesirable effects

Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion ...

Overdose

No symptoms of overdose with human coagulation factor IX have been reported.

Pharmacodynamic properties

Pharmacotherapeutic Group: antihemorrhagics: blood coagulation factor IX ATC code: B02BD04 Factor IX ...

Pharmacokinetic properties

A pharmacokinetic study with 13 patients yielded the following results: Using a biphasic model the mean ...

Preclinical safety data

The preparation contains exclusively human plasma derived proteins, namely high purity coagulation factor ...

List of excipients

Powder: Arginine Lysine Sodium chloride Sodium citrate Solvent: Water for injections.

Incompatibilities

This medicinal product must not be mixed with other medicinal products. Only the provided injection sets ...

Shelf life

2 years. The product should be used immediately after reconstitution.

Special precautions for storage

Do not store above 25°C. Do not freeze. Keep the vials in the outer carton in order to protect from light. ...

Nature and contents of container

1 package Haemonine® 500 contains 1 vial with powder, glass type I (Ph.Eur.), closed with chlorobutyl ...

Special precautions for disposal and other handling

Absolute sterility is to be ensured in all steps of the procedure ! Dissolution of the concentrate: ...

Marketing authorization holder

Biotest Pharma GmbH Landsteinerstrasse 5 63303 Dreieich Germany Phone: +49 6103 801-0 Fax: +49 6103 801-150 ...

Marketing authorization number(s)

PL 04500/0008

Date of first authorization / renewal of the authorization

19/12/2008

Date of revision of the text

19/12/2008
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.