FIBROGAMMIN Powder and solvent for solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Fibrogammin 250/1250 IU. Powder and solvent for solution for injection or infusion.
Qualitative and quantitative composition
Active substance: Fibrogammin is a purified concentrate of blood coagulation factor XIII (FXIII). It is derived from human plasma and is presented as a white powder. Each vial contains nominally 250 or ...
Pharmaceutical form
Powder and solvent for solution for injection/infusion. White powder and clear, colourless solvent.
Therapeutic indications
Fibrogammin is indicated for adult and paediatric patients. Congenital deficiency of Factor XIII and resultant haemorrhagic diathesis, haemorrhages and disturbances in wound healing.
Posology and method of administration
Posology 1 ml is equivalent to 62.5 IU, and 100 IU are equivalent to 1.6 ml, respectively. Important: The amount to be administered and the frequency of administration should always be orientated towards ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
In patients with known allergies to the product, with symptoms such as generalised urticaria, rash, a fall in blood pressure, dyspnoea, antihistamines and corticosteroids may be administered prophylactically. ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Fertility, pregnancy and lactation
Pregnancy Limited data on the clinical use of Fibrogammin in pregnancy did not show any negative effects on the course of gestation and the peri- or postnatal development. The use of Fibrogammin may be ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Undesirable effects
The following adverse reactions are based on post-marketing experience. Tabulated list of adverse reactions The table presented below is according to the MedDRA system organ classification. Frequencies ...
Overdose
No cases of overdose have been reported.
Pharmacodynamic properties
Pharmacotherapeutic group: Antihaemorrhagics ATC code: B02BD07 Biochemically, factor XIII acts as transglutaminase. Factor XIII connects the amino group of lysine with glutamine via its enzymatic function ...
Pharmacokinetic properties
Distribution The product is administered intravenously, and is thus immediately bioavailable resulting in a plasma concentration corresponding to the applied dose. Elimination In patients with congenital ...
Preclinical safety data
The proteins contained in Fibrogammin are sourced from human plasma and act like human plasma proteins. Single and repeated dose toxicity studies in animals did not reveal a toxic potential for Fibrogammin. ...
List of excipients
Powder: Human albumin Glucose monohydrate Sodium chloride* Sodium hydroxide (for pH adjustment) * see also section 4.4 Solvent: Water for Injections
Incompatibilities
Fibrogammin must not be mixed with other medicinal products, diluents, or solvents except those mentioned in section 6.6 and should be administered by a separate infusion line.
Shelf life
Shelf life: 3 years. Do not use after the expiry date given on the pack and container. Do not freeze reconstituted solution. Chemical and physical in-use stability has been demonstrated for 24 hours at ...
Special precautions for storage
Store in a refrigerator (+2 to +8 °C). Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after reconstitution of the medicinal product, see section ...
Nature and contents of container
Vials 250 IU: Powder: injection vial of colourless glass, sealed with a bromobutyl rubber stopper, aluminium cap and plastic disc. Solvent (Water for Injections): vial of colourless glass 1250 IU: Powder: ...
Special precautions for disposal and other handling
General instructions The solution should be clear or slightly opalescent. After filtering/withdrawal (see below) the reconstituted product should be inspected visually for particulate matter and discoloration ...
Marketing authorization holder
CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041, Marburg, Germany
Marketing authorization number(s)
PL 15036/0006
Date of first authorization / renewal of the authorization
22 June 1998 / 30 October 2003
Date of revision of the text
16 July 2018
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