RIASTAP Powder for solution for injection or infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Riastap 1 g Powder for solution for injection/infusion.
Qualitative and quantitative composition
Riastap is presented as a powder for solution for injection or infusion containing 1 g human fibrinogen per vial. The product reconstituted with 50 ml of water for injections contains approximately 20 ...
Pharmaceutical form
Powder for solution for injection/infusion. White powder.
Therapeutic indications
Treatment of bleeding in patients with congenital hypo-, or afibrinogenaemia with bleeding tendency.
Posology and method of administration
Treatment should be initiated under the supervision of a physician experienced in the treatment of coagulation disorders. Posology The dosage and duration of the substitution therapy depend on the severity ...
Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
There is a risk of thrombosis when patients with congenital deficiency are treated with human fibrinogen concentrate, particularly with high dose or repeated dosing. Patients given human fibrinogen concentrate ...
Interaction with other medicinal products and other forms of interaction
No interactions of human plasma fibrinogen concentrate with other medicinal products are known.
Fertility, pregnancy and lactation
Pregnancy Animal reproduction studies have not been conducted with Riastap (see section 5.3). Since the active substance is of human origin, it is catabolised in the same manner as the patients own protein. ...
Effects on ability to drive and use machines
Riastap has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Tabulated list of adverse drug reactions (ADRs) The table combines the adverse reactions identified from clinical trials and post-marketing experience. Frequencies presented in the table have been based ...
Overdose
In order to avoid overdosage, regular monitoring of the plasma level of fibrinogen during therapy is indicated (see 4.2). In case of overdosage, the risk of development of thromboembolic complications ...
Pharmacodynamic properties
Pharmacotherapeutic group: antihaemorrhagics, human fibrinogen ATC code: B02BB01 Human fibrinogen (coagulation factor I), in the presence of thrombin, activated coagulation factor XIII (F XIIIa) and calcium ...
Pharmacokinetic properties
Human fibrinogen is a normal constituent of human plasma and acts like endogenous fibrinogen. In plasma, the biological half-life of fibrinogen is 3 to 4 days. Regarding degradation, Riastap behaves like ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of single dose toxicity and safety pharmacology. Preclinical studies with repeated dose applications (chronic toxicity, ...
List of excipients
Human albumin L-arginine hydrochloride Sodium hydroxide (for pH adjustment) Sodium chloride Sodium citrate
Incompatibilities
This product must not be mixed with other medicinal products, diluents or solvents except those mentioned in section 6.6. A standard infusion set is recommended for intravenous application of the reconstituted ...
Shelf life
Shelf life: 5 years. The physico-chemical stability for the reconstituted product has been demonstrated for 8 hours at room temperature (max. +25°C). From a microbiological point of view the product should ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Keep the vial in the outer carton, in order to protect from light.
Nature and contents of container
Vial of colourless glass, Type II Ph. Eur., sealed with a latex-free stopper (bromobutyl rubber), aluminium cap and plastic disc. Pack with 1 g (Figure 1): 1. One vial containing 1 g human fibrinogen ...
Special precautions for disposal and other handling
General instructions: Reconstitution and withdrawal should be carried out under aseptic conditions. Reconstituted products should be inspected visually for particulate matter and discoloration prior to ...
Marketing authorization holder
CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041, Marburg, Germany
Marketing authorization number(s)
PL 15036/0033
Date of first authorization / renewal of the authorization
16 August 2010 / 12 June 2014
Date of revision of the text
22 April 2020
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