ETOPOPHOS Powder for solution for injection (2021)
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Περιεχόμενα
Name of the medicinal product
ETOPOPHOS 100mg Powder for Solution for Injection.
Qualitative and quantitative composition
Each vial contains 113.6 mg etoposide phosphate equivalent to 100 mg etoposide. For the full list of excipients, see section 6.1.
Pharmaceutical form
Powder for solution for injection. White to off-white dry powder.
Therapeutic indications
Testicular cancer ETOPOPHOS is indicated in combination with other approved chemotherapeutic agents for the treatment of first line, recurrent or refractory testicular cancer in adults. Small cell lung ...
Posology and method of administration
ETOPOPHOS 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). Adult population The recommended ...
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
ETOPOPHOS 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 ETOPOPHOS ...
Interaction with other medicinal products and other forms of interaction
Effects of other drugs on the pharmacokinetics of etoposide phosphate High dose ciclosporin, resulting in plasma concentrations above 2000 ng/mL, administered with oral etoposide has led to an 80% increase ...
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 phosphate may cause adverse reactions that affect the ability to drive or use machines such as fatigue, ...
Undesirable effects
Summary of the safety profile Dose limiting bone marrow suppression is the most significant toxicity associated with ETOPOPHOS therapy. In clinical studies in which ETOPOPHOS was administered as a single ...
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
<b>Pharmacotherapeutic group:</b> Cytostatics, plant alkaloids and other natural products, podophyllotoxin derivatives <b>ATC code:</b> L01CB01 Mechanism of action Etoposide phosphate is metabolised in ...
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. Distribution The mean volumes of distribution ...
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
Dextran 40 Sodium citrate
Incompatibilities
ETOPOPHOS should not be physically mixed with any other drug.
Shelf life
3 Years. Storage conditions after reconstitution of the medicinal product After reconstitution: chemical and physical in-use stability has been demonstrated for 24 hours at 15 to 30°C and for 7 days at ...
Special precautions for storage
Store in a refrigerator (2 to 8°C). Store in the original package in order to protect from light.
Nature and contents of container
Type I glass vial with a butyl rubber stopper and flip-off aluminium seal. Packs of 1, 5, 10, 20, 25 vials. 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. As with other potentially ...
Marketing authorization holder
Neon Healthcare Limited, Mill Studio Business Centre, Crane Mead, Ware, Hertfordshire, SG12 9PY, United Kingdom
Marketing authorization number(s)
PL 45043/0038
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 May 1996 Date of latest renewal: 22 Jan 2007
Date of revision of the text
25/01/2021
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