TORISEL Concentrate and solvent for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Torisel 30 mg concentrate and solvent for solution for infusion.
Qualitative and quantitative composition
Each vial of concentrate for solution for infusion contains 30 mg temsirolimus. After first dilution of the concentrate with 1.8 ml of solvent, the concentration of temsirolimus is 10 mg/ml (see section ...
Pharmaceutical form
Concentrate and solvent for solution for infusion (sterile concentrate). The concentrate is a clear, colourless to light-yellow solution, free from visible particulates. The solvent is a clear to slightly ...
Therapeutic indications
Renal cell carcinoma Torisel is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors (see section 5.1). ...
Posology and method of administration
This medicinal product must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products. Posology Patients should be given intravenous diphenhydramine ...
Contraindications
Hypersensitivity to temsirolimus, its metabolites (including sirolimus), polysorbate 80, or to any of the excipients listed in section 6.1. Use of temsirolimus in patients with MCL with moderate or severe ...
Special warnings and precautions for use
The incidence and severity of adverse events is dose-dependent. Patients receiving the starting dose of 175 mg weekly for the treatment of MCL must be followed closely to decide on dose reductions/delays. ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. Concomitant use of temsirolimus with sunitinib The combination of temsirolimus and sunitinib resulted in dose-limiting toxicity. Dose-limiting toxicities ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females Due to the unknown risk related to potential exposure during early pregnancy, women of childbearing potential must be advised not to become ...
Effects on ability to drive and use machines
Temsirolimus has no or negligible influence on the ability to drive and use machines based on the evidence available. For patients receiving the higher dose of 175 mg intravenous of temsirolimus for the ...
Undesirable effects
Summary of the safety profile The most serious reactions observed with temsirolimus in clinical trials are hypersensitivity/infusion reactions (including some life-threatening and rare fatal reactions), ...
Overdose
There is no specific treatment for temsirolimus overdose. While temsirolimus has been safely administered to patients with renal cancer with repeated intravenous doses as high as 220 mg/m², in MCL, two ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors ATC code: L01XE09 Mechanism of action Temsirolimus is a selective inhibitor of mTOR (mammalian target of rapamycin). Temsirolimus ...
Pharmacokinetic properties
Absorption Following administration of a single 25 mg intravenous dose of temsirolimus in patients with cancer, mean C<sub>max</sub> in whole blood was 585 ng/ml (coefficient of variation [CV] = 14%), ...
Preclinical safety data
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to or even lower than clinical exposure levels and with possible relevance to clinical use, were as follows: ...
List of excipients
Concentrate: Anhydrous ethanol all-rac-α-Tocopherol (E307) Propylene glycol Citric acid (E330) Solvent: Polysorbate 80 (E433) Macrogol 400 Anhydrous ethanol
Incompatibilities
This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6. Torisel 30 mg concentrate must not be added directly to aqueous infusion solutions. Direct ...
Shelf life
Shelf life Unopened vial: 3 years. After first dilution of Torisel 30 mg concentrate with 1.8 ml of the supplied solvent: 24 hours when stored below 25°C and protected from light. After further dilution ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vials in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
Concentrate: Clear glass vial (type 1), with butyl rubber stopper and a plastic flip-top closure sealed with aluminum containing 1.2 ml of concentrate. Solvent: Clear glass vial (type 1), with butyl rubber ...
Special precautions for disposal and other handling
During handling and preparation of admixtures, Torisel should be protected from excessive room light and sunlight. Torisel, when diluted, contains polysorbate 80 and therefore appropriate administration ...
Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Marketing authorization number(s)
EU/1/07/424/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 19 November 2007 Date of the latest renewal: 13 July 2017
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