HYCAMTIN Powder for concentrate for solution for infusion (2018)
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Περιεχόμενα
Name of the medicinal product
HYCAMTIN 1 mg powder for concentrate for solution for infusion. HYCAMTIN 4 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
<u>HYCAMTIN 1 mg powder for concentrate for solution for infusion:</u> Each vial contains 1 mg topotecan (as hydrochloride). The total content of active substance in the vial provides 1 mg per ml of active ...
Pharmaceutical form
Powder for concentrate for solution for infusion. Light yellow to greenish powder.
Therapeutic indications
Topotecan monotherapy is indicated for the treatment of: patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy. patients with relapsed small cell lung cancer ...
Posology and method of administration
The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy. Topotecan should only be administered under the supervision of a physician experienced in the ...
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 dose-finding studies involving 523 patients with relapsed ovarian cancer and 631 patients with relapsed small cell lung cancer, the dose-limiting toxicity of topotecan monotherapy was found to be haematological. ...
Overdose
Overdoses have been reported in patients being treated with intravenous topotecan (up to 10 fold of the recommended dose) and topotecan capsules (up to 5 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 Following intravenous administration of topotecan at doses of 0.5 to 1.5 mg/m² as a 30-minute infusion daily for five days, topotecan demonstrated a high plasma clearance of 62 l/h (SD 22), ...
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
Tartaric acid (E334) Mannitol (E421) Hydrochloric acid (E507) Sodium hydroxide
Incompatibilities
None known.
Shelf life
<u>Vials:</u> 3 years. <u>Reconstituted and diluted solutions:</u> The product should be used immediately after reconstitution as it contains no antibacterial preservative. If reconstitution and dilution ...
Special precautions for storage
Keep the vial in the outer carton in order to protect from light. For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Nature and contents of container
<u>HYCAMTIN 1 mg powder for concentrate for solution for infusion:</u> Type I flint glass vial with grey butyl rubber stopper and aluminium seal with plastic flip-off cap containing 1 mg of topotecan. ...
Special precautions for disposal and other handling
HYCAMTIN 1 mg powder for concentrate for solution for infusion The contents of HYCAMTIN 1 mg vials must be reconstituted with 1.1 ml water for injections. Since the vial contains a 10% overage, the clear, ...
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
<u>HYCAMTIN 1 mg powder for concentrate for solution for infusion:</u> EU/1/96/027/004 EU/1/96/027/005 <u>HYCAMTIN 4 mg powder for concentrate for solution for infusion:</u> EU/1/96/027/001 EU/1/96/027/003 ...
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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