HYCAMTIN Hard capsule (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
HYCAMTIN 0.25 mg hard capsules HYCAMTIN 1 mg hard capsules
Qualitative and quantitative composition
<u>HYCAMTIN 0.25 mg hard capsules:</u> Each capsule contains 0.25 mg of topotecan (as hydrochloride). <u>HYCAMTIN 1 mg hard capsules:</u> Each capsule contains 1 mg of topotecan (as hydrochloride). For ...
Pharmaceutical form
Hard capsule. <u>HYCAMTIN 0.25 mg hard capsules:</u> The capsules are opaque, white to yellowish white and imprinted with HYCAMTIN and 0.25 mg. <u>HYCAMTIN 1 mg hard capsules:</u> The capsules are opaque, ...
Therapeutic indications
HYCAMTIN capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate ...
Posology and method of administration
HYCAMTIN capsules should only be prescribed and therapy supervised by a physician experienced in the use of chemotherapeutic agents. Posology Prior to administration of the first course of topotecan, patients ...
Contraindications
Severe hypersensitivity to the active substance or to any of the excipients. Breast-feeding (see section 4.6). Severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils ...
Special warnings and precautions for use
Haematological toxicity is dose-related and full blood count including platelets should be determined regularly (see section 4.2). As with other cytotoxic medicinal products, topotecan can cause severe ...
Interaction with other medicinal products and other forms of interaction
No in vivo human pharmacokinetic interaction studies have been performed. Topotecan does not inhibit human P450 enzymes (see section 5.2). In a population study using the intravenous route, the co-administration ...
Pregnancy and lactation
Women of childbearing potential / Contraception in males and females Topotecan has been shown to cause embryo-foetal lethality and malformations in preclinical studies (see section 5.3). As with other ...
Effects on ability to drive and use machines
No studies of the effects on the ability to drive and use machines have been performed. However, caution should be observed when driving or operating machines if fatigue and asthenia persist.
Undesirable effects
In clinical studies involving patients with relapsed small cell lung cancer, the dose-limiting toxicity of oral topotecan monotherapy was found to be haematological. Toxicity was predictable and reversible. ...
Overdose
Overdoses have been reported in patients being treated with topotecan capsules (up to 5 fold of the recommended dose) and intravenous topotecan (up to 10 fold of the recommended dose). The signs and symptoms ...
Pharmacodynamic properties
Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents ATC code: L01XX17 Mechanism of action The anti-tumour activity of topotecan involves the inhibition of topoisomerase-I, an ...
Pharmacokinetic properties
Distribution The pharmacokinetics of topotecan after oral administration have been evaluated in cancer patients following doses of 1.2 to 3.1 mg/m²/day and 4 mg/m²/day administered daily for 5 days. The ...
Preclinical safety data
Resulting from its mechanism of action, topotecan is genotoxic to mammalian cells (mouse lymphoma cells and human lymphocytes) in vitro and mouse bone marrow cells in vivo. Topotecan was also shown to ...
List of excipients
HYCAMTIN 0.25 mg hard capsules <u>Capsule contents:</u> Hydrogenated vegetable oil Glyceryl monostearate <u>Capsule shell:</u> Gelatin Titanium dioxide (E171) <u>Sealing band:</u> Gelatin <u>Black ink: ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the blister in the outer carton in order to protect from light.
Nature and contents of container
White polyvinyl chloride / polychlorotrifluoroethylene blister sealed with aluminium / Polyethylenterephtalate (PET) / paper foil lidding. The blisters are sealed with a peel-push child resistant opening ...
Special precautions for disposal and other handling
HYCAMTIN capsules should not be opened or crushed. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
HYCAMTIN 0.25 mg hard capsules: EU/1/96/027/006 HYCAMTIN 1 mg hard capsules: EU/1/96/027/007
Date of first authorization / renewal of the authorization
Date of first authorisation: 12 November 1996 Date of latest renewal: 20 November 2006
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