Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του galinos.gr από το 2011 μέχρι σήμερα
 

SPC, Ireland: FEIBA (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Baxter Healthcare Ltd
Διεύθυνση :
Caxton Way, Thetford, IP243 SE, Norfolk, United Kingdom
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

Name of the medicinal product

FEIBA 1000 U powder and solvent for solution for infusion.

Qualitative and quantitative composition

Active substance: Factor VIII Inhibitor Bypassing Activity As the active ingredient, FEIBA 1000 U* contains 1000 U factor VIII inhibitor bypassing activity in 400 1200 mg human plasma protein. FEIBA also ...

Pharmaceutical form

Powder and solvent for solution for infusion. White, off-white or pale green powder. The pH value of the ready-to-use solution is between 6.8 and 7.6.

Therapeutic indications

Treatment of bleeding episodes in patients with hemophilia A and factor VIII inhibitors Treatment of bleeding in non-hemophiliacs with acquired inhibitors to factor VIII. Prophylaxis of bleeding in inhibitor ...

Posology and method of administration

The treatment is to be initiated and monitored by a physician experienced in the treatment of coagulation disorders. Posology Dosage and duration of treatment depend on the severity of the haemostatic ...

Contraindications

FEIBA must not be used in the following situations if therapeutic alternatives to FEIBA are available: Hypersensitivity to the product or any of the components. Disseminated Intravascular Coagulation (DIC) ...

Special warnings and precautions for use

WARNINGS Risk of Thrombotic and Thromboembolic Events Thrombotic and thromboembolic events, including disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial infarction, ...

Interaction with other medicinal products and other forms of interaction

It is not recommended to administer antifibrinolytics, such as epsilon aminocaproic acid, together with FEIBA. If application of both, antifibrinolytics such as epsilon aminocaproic acid and FEIBA, is ...

Fertility, pregnancy and lactation

The safety of FEIBA during pregnancy and lactation has not been established. Physicians should carefully consider the potential risks and benefits for each specific patient before prescribing FEIBA. Pregnancy ...

Effects on ability to drive and use machines

FEIBA has no, or negligible, influence on the ability to drive or to use machines.

Undesirable effects

The adverse reactions listed in the following were reported within the framework of either post-marketing surveillance or clinical trials. Frequency categories: very common > 1/10 common > 1/100 to <1/10 ...

Overdose

Overdose of FEIBA may increase the risk of undesired events such as thromboembolism, DIC or myocardial infarction (see Section 4.4).

Pharmacodynamic properties

Pharmacotherapeutic group: blood coagulation factors ATC code: B02BD03 Although FEIBA was developed in the early seventies and its factor VIII inhibitor bypassing activity has been proven in vitro as well ...

Pharmacokinetic properties

As the mode of action of FEIBA is still being discussed, it is not possible to make a conclusive statement about the pharmacokinetic properties.

Preclinical safety data

Based on acute toxicity studies in factor VIII knockout mice and in normal mice, and in rats, with doses higher than the maximum daily dose in humans (> 200 U/kg body weight), it can be concluded that ...

List of excipients

Powder: Sodium chloride Sodium citrate Solvent: Sterilized Water for Injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products except the solvent mentioned in Section 6.6. As in all blood coagulation preparations, the efficacy and tolerance of the medicinal ...

Shelf life

Two years. Chemical and physical in-use stability has been demonstrated for 3 hours at room temperature. From a microbiological point of view, unless the method of reconstitution precludes the risk of ...

Special precautions for storage

Do not store above 25°C. Do not freeze. Store in the original package in order to protect from light. For storage conditions of the reconstituted medicinal product see section 6.3.

Nature and contents of container

The powder is supplied in a vial made of surface treated, colorless glass (hydrolytic class II). The solvent is supplied in a vial made of surface treated, colorless glass (hydrolytic class I). The vials ...

Special precautions for disposal and other handling

FEIBA is to be reconstituted immediately prior to administration. The solution should be used immediately (as the preparation does not contain preservatives). Swirl gently until all material is dissolved. ...

Marketing authorization holder

Baxter Healthcare Limited Caxton Way Thetford IP243 SE Norfolk United Kingdom

Marketing authorization number(s)

PA 167/138/2

Date of first authorization / renewal of the authorization

Date of first authorisation: 28th May 2010

Date of revision of the text

April 2011

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

File
application/pdf - 2,1 MB

Σχετικά φαρμακευτικά σκευάσματα

Κωδικός Όνομα Κ Ν.Τ. Χ.Τ. Λ.Τ. Υπεύθυνος κυκλοφορίας
29037.02.01 FEIBA PS.SOL.INF 1000 U/20ML BTx1VIAL FEIBA 1000U +1 VIALx20 ML WATER FOR INJECTIONS+1σετ από συσκευές χορήγησης (1 σύριγγα μιας χρήσης+1 βελόνα μιας χήσης+1 βελόνα-πεταλούδα με σφιγκτήρα+1 βελόνα φίλτρου+1 βελόνα μεταφοράς+1 βελόνα αερισμού) 619,50 € 689,01 € 781,47 € Baxter Hellas Ε.Π.Ε.
29037.01.02 FEIBA PS.SOL.INF 25 U/ML BTx1VIAL FEIBA 500 U +1 VIALx20 ML WATER FOR INJECTIONS+1σετ από συσκευές χορήγησης (1 συσκευή BAXJECT II Hi-FLOW+1 σύριγγα μιας χρήσησ+1 μελόνα πεταλούδα με σφιγκτήρα) 309,74 € 344,50 € 401,69 € Baxalta Innovations GmbH
29037.02.02 FEIBA PS.SOL.INF 50 U/ML BTx1VIAL FEIBA 1000U +1 VIALx20 ML WATER FOR INJECTIONS+1σετ από συσκευές χορήγησης (1 συσκευή BAXJECT II Hi-FLOW+1 σύριγγα μιας χρήσης+1 βελόνα πεταλούδα με σφιγκτήρα) +1 VIALx20 ML WATER FOR INJECTIONS+1σετ από συσκευές χορήγησ 619,48 € 689,01 € 781,47 € Baxalta Innovations GmbH
29037.01.01 FEIBA PS.SOL.INF 500 U/20ML BTx1VIAL FEIBA 500 U +1 VIALx20 ML WATER FOR INJECTIONS+1σετ από συσκευές χορήγησης (1 σύριγγα μιας χρήσης+1 βελόνα μιας χήσης+1 βελόνα-πεταλούδα με σφιγκτήρα+1 βελόνα φίλτρου+1 βελόνα μεταφοράς+1 βελόνα αερισμού) 309,75 € 344,50 € 401,69 € Baxter Hellas Ε.Π.Ε.