RAPAMUNE Coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Rapamune 0.5 mg coated tablets. Rapamune 1 mg coated tablets. Rapamune 2 mg coated tablets.
Qualitative and quantitative composition
Rapamune 0.5 mg coated tablets: Each coated tablet contains 0.5 mg sirolimus. Rapamune 1 mg coated tablets: Each coated tablet contains 1 mg sirolimus. Rapamune 2 mg coated tablets: Each coated tablet ...
Pharmaceutical form
Coated tablet (tablet). Rapamune 0.5 mg coated tablets: Tan-coloured, triangular-shaped, coated tablet marked RAPAMUNE 0.5 mg on one side. Rapamune 1 mg coated tablets: White-coloured, triangular-shaped, ...
Therapeutic indications
Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination ...
Posology and method of administration
Posology Prophylaxis of organ rejection Treatment should be initiated by and remain under the guidance of an appropriately qualified specialist in transplantation. Initial therapy (2 to 3 months post-transplantation) ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Rapamune has not been adequately studied in renal transplant patients at high immunological risk, therefore use is not recommended in this group of patients (see section 5.1). In renal transplant patients ...
Interaction with other medicinal products and other forms of interaction
Sirolimus is extensively metabolised by the CYP3A4 isozyme in the intestinal wall and liver. Sirolimus is also a substrate for the multidrug efflux pump, P-glycoprotein (P-gp) located in the small intestine. ...
Fertility, pregnancy and lactation
Women of childbearing potential Effective contraception must be used during Rapamune therapy and for 12 weeks after Rapamune has been stopped (see section 4.5). Pregnancy There are no or limited amount ...
Effects on ability to drive and use machines
Rapamune has no known influence on the ability to drive and use machines. No studies on the effects on the ability to drive and use machines have been performed.
Undesirable effects
Undesirable effects observed with prophylaxis of organ rejection in renal transplantation The most commonly reported adverse reactions (occurring in 10% of patients) are thrombocytopaenia, anaemia, pyrexia, ...
Overdose
At present, there is minimal experience with overdose. One patient experienced an episode of atrial fibrillation after ingestion of 150 mg of Rapamune. In general, the adverse effects of overdose are consistent ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants ATC code: L04AA10 Sirolimus inhibits T-cell activation induced by most stimuli, by blocking calcium-dependent and calcium-independent ...
Pharmacokinetic properties
Much of the general pharmacokinetic information was obtained using the Rapamune oral solution, which is summarised first. Information directly related to the tablet formulation is summarised specifically ...
Preclinical safety data
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use, were as follows: pancreatic islet ...
List of excipients
Tablet core: Lactose monohydrate Macrogol Magnesium stearate Talc Tablet coating: Rapamune 0.5 mg coated tablets: Macrogol Glycerol monooleate Pharmaceutical glaze (shellac) Calcium sulfate Microcrystalline ...
Incompatibilities
Not applicable.
Shelf life
<u>Rapamune 0.5 mg coated tablets:</u> 2 years. <u>Rapamune 1 mg coated tablets:</u> 3 years. <u>Rapamune 2 mg coated tablets:</u> 3 years.
Special precautions for storage
Do not store above 25°C. Keep the blister in the outer carton in order to protect from light.
Nature and contents of container
Clear polyvinyl chloride (PVC)/polyethylene (PE)/polychlorotrifluoroethylene (Aclar) aluminium blister packages of 30 and 100 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Marketing authorization number(s)
Rapamune 0.5 mg coated tablets: EU/1/01/171/013-14 Rapamune 1 mg coated tablets: EU/1/01/171/007-8 Rapamune 2 mg coated tablets: EU/1/01/171/009-010
Date of first authorization / renewal of the authorization
Date of first authorisation: 13 March 2001 Date of latest renewal: 13 March 2011
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