XIGRIS Powder for solution for infusion (2012)
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Περιεχόμενα
Name of the medicinal product
Xigris 20 mg powder for solution for infusion.
Qualitative and quantitative composition
Each vial contains 20 mg of Drotrecogin alfa (activated). After reconstitution with 10 ml of Water for Injection each ml contains 2 mg of Drotrecogin alfa (activated). Drotrecogin alfa (activated) is a ...
Pharmaceutical form
Powder for solution for infusion. Xigris is supplied as a lyophilised, white to off-white powder.
Therapeutic indications
Xigris is indicated for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care. The use of Xigris should be considered mainly in situations when ...
Posology and method of administration
Xigris should be used by experienced doctors in institutions skilled in the care of patients with severe sepsis. Treatment should be started within 48 hours, and preferably within 24 hours, of onset of ...
Contraindications
Hypersensitivity to the active substance, to any of the excipients or to bovine thrombin (a trace residue from the manufacturing process). Drotrecogin alfa (activated) is contraindicated in children below ...
Special warnings and precautions for use
No further study has confirmed the efficacy results of the single pivotal trial. Patients with single organ dysfunction and recent surgery Xigris is not approved for the treatment of patients with single ...
Interaction with other medicinal products and other forms of interaction
Caution should be employed when Xigris is used with other drugs that affect haemostasis (see sections 4.3 and 4.4) including Protein C, thrombolytics (e.g. streptokinase, tPA, rPA and urokinase), oral ...
Pregnancy and lactation
Animal studies with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development have not been conducted with Xigris. Therefore, the potential risk for humans is ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Xigris increases the risk of bleeding. The Phase 3 international, multi-centre, randomised, double-blind, placebo-controlled clinical trial (PROWESS) involved 850 drotrecogin alfa (activated)-treated and ...
Overdose
In clinical trials and in post marketing experience there have been reports of accidental overdosing. In the majority of cases, no reactions have been observed. For the other reports, the observed events ...
Pharmacodynamic properties
Pharmacotherapeutic group: antithrombotic agents, enzymes ATC code: B01AD10 This medicinal product has been authorised under Exceptional Circumstances. This means that for scientific reasons it has not ...
Pharmacokinetic properties
Drotrecogin alfa (activated) and endogenous human Activated Protein C are inactivated in plasma by endogenous protease inhibitors but the mechanism by which they are cleared from plasma is unknown. Plasma ...
Preclinical safety data
Changes observed in monkeys at, or in small excess of, the maximum human exposure during repeated dose studies, were all related to the pharmacological effect of Xigris and include beside the expected ...
List of excipients
Sucrose Sodium chloride Sodium citrate Citric acid Hydrochloric acid Sodium hydroxide
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life: 3 years. After reconstitution, immediate use is recommended. However, the reconstituted solution in the vial may be held for up to 3 hours at room temperature (15°C-30°C). After preparation, ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Keep the vial in the outer carton in order to protect from light.
Nature and contents of container
Powder in Type I glass vial. Pack of 1 vial.
Special precautions for disposal and other handling
Use appropriate aseptic technique during the preparation of Xigris for intravenous administration. Calculate the dose and the number of Xigris vials needed. Each Xigris vial contains 20 mg of drotrecogin ...
Marketing authorization holder
Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA, Houten, The Netherlands
Marketing authorization number(s)
EU/1/02/225/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 22 August 2002
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