VEPESID Capsule, soft (2019)
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Περιεχόμενα
Name of the medicinal product
VEPESID 50 mg capsule, soft.
Qualitative and quantitative composition
Each capsule contains 50 mg etoposide. Excipients with known effect: Each 50 mg capsule, soft contains: 0.93 mg of sodium ethyl parahydroxybenzoate (E215) and 0.47 mg of sodium propyl parahydroxybenzoate ...
Pharmaceutical form
Capsule, Soft. Opaque pink.
Therapeutic indications
Recurrent or refractory testicular cancer VEPESID is indicated in combination with other approved chemotherapeutic agents for the treatment of recurrent or refractory testicular cancer in adults. Small ...
Posology and method of administration
VEPESID capsules should only be administered and monitored under the supervision of a qualified physician experienced in the use of anti-neoplastic medicinal products (see section 4.4). Posology The dose ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant use of yellow fever vaccine or other live vaccines is contraindicated in immunosuppressed patients ...
Special warnings and precautions for use
VEPESID should only be administered and monitored under the supervision of a qualified physician experienced in the use of anti-neoplastic medicinal products. In all instances where the use of VEPESID ...
Interaction with other medicinal products and other forms of interaction
Effects of other drugs on the pharmacokinetics of etoposide High dose ciclosporin, resulting in plasma concentrations above 2000 ng/mL, administered with oral etoposide has led to an 80% increase in etoposide ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females Women of childbearing potential should use appropriate contraceptive measures to avoid pregnancy during etoposide therapy. Etoposide has ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Etoposide may cause adverse reactions that affect the ability to drive and use machines such as fatigue, somnolence, ...
Undesirable effects
Summary of the safety profile Dose limiting bone marrow suppression is the most significant toxicity associated with VEPESID therapy. In clinical studies in which VEPESID was administered as a single agent ...
Overdose
Total doses of 2.4 g/m² to 3.5 g/m² administered intravenously over three days have resulted in severe mucositis and myelotoxicity. Metabolic acidosis and cases of serious hepatic toxicity have been reported ...
Pharmacodynamic properties
Pharmacotherapeutic group: Cytostatics, plant alkaloids and other natural products, podophyllotoxin derivatives ATC code: L01CB01 Mechanism of action The main effect of etoposide appears to be at the late ...
Pharmacokinetic properties
Absorption After either intravenous infusion or oral capsule administration, the C<sub>max</sub> and AUC values exhibit marked intra- and inter-subject variability. The oral bioavailability is variable ...
Preclinical safety data
Chronic toxicity Anaemia, leucopenia, and thrombocytopenia were observed in rats and mice, while dogs had mild reversible deterioration of liver and kidney functions. The dose multiple (based on mg/m² ...
List of excipients
<u>Capsule content:</u> Citric acid, anhydrous (E330) Macrogol 400 (E1521) Glycerol (85 per cent) (E422) Water, purified <u>Capsule shell:</u> Glycerol (85 per cent) (E422) Gelatin (E441) Sodium ethyl ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C. Store in the original package. Do not open any blister in which there is evidence of capsule leakage.
Nature and contents of container
Pack of 20, 50 Capsules, softgels. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Procedures for proper handling and disposal of anti-cancer drugs should be followed. Care must be taken whenever handling cytostatic products. Always take steps to prevent exposure. This includes appropriate ...
Marketing authorization holder
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany
Marketing authorization number(s)
PL 27041/0016
Date of first authorization / renewal of the authorization
29 April 1983 / 18 September 2002
Date of revision of the text
19/07/2019
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