JAVLOR Concentrate for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Javlor 25 mg/mL concentrate for solution for infusion.
Qualitative and quantitative composition
One mL of concentrate contains 25 mg of vinflunine (as ditartrate). One 2 mL vial contains 50 mg of vinflunine (as ditartrate). One 4 mL vial contains 100 mg of vinflunine (as ditartrate). One 10 mL vial ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). Clear, colourless to pale yellow solution.
Therapeutic indications
Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen. ...
Posology and method of administration
Vinflunine treatment should be initiated under the responsibility of a physician qualified in the use of anticancer chemotherapy and is confined to units specialised in the administration of cytotoxic ...
Contraindications
Hypersensitivity to the active substance or other vinca alkaloids. Recent (within 2 weeks) or current severe infection. Baseline ANC <1,500/mm³ for the first administration, baseline ANC <1,000/mm³ for ...
Special warnings and precautions for use
Hematological toxicity Neutropenia, leucopenia, anaemia and thrombocytopenia are frequent adverse reactions of vinflunine. Adequate monitoring of complete blood counts should be conducted to verify the ...
Interaction with other medicinal products and other forms of interaction
In vitro studies showed that vinflunine had neither inducing effects on CYP1A2, CYP2B6 or CYP3A4 activity nor inhibition effects on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4. In vitro ...
Fertility, pregnancy and lactation
Contraception in males and females Both male and female patients should take adequate contraceptive measures up to three months after the discontinuation of the therapy. Pregnancy There are no data available ...
Effects on ability to drive and use machines
Javlor may cause adverse reactions such as fatigue (very common) and dizziness (common) which may lead to a minor or moderate influence on the ability to drive and use machines. Patients should be advised ...
Undesirable effects
Summary of the safety profile The most frequent treatment-related adverse reactions reported in the two phase II and one phase III trials in patients with transitional cell carcinoma of the urothelium ...
Overdose
The main toxic effect due to an overdose with vinflunine is bone marrow suppression with a risk of severe infection. There is no known antidote for vinflunine overdose. In case of overdose, the patient ...
Pharmacodynamic properties
Pharmacotherapeutic group: antineoplasic agents, vinca alkaloids and analogues ATC code: L01CA05 Mechanism of action Vinflunine binds to tubulin at or near to the vinca binding sites inhibiting its polymerisation ...
Pharmacokinetic properties
Vinflunine pharmacokinetics is linear in the range of administered doses (from 30 mg/m² to 400 mg/m²) in cancer patients. Blood exposure to vinflunine (AUC), significantly correlated with severity of leucopenia, ...
Preclinical safety data
Imaging distribution studies following radioactive vinflunine in rats, illustrated that the compound levels in lungs, kidneys, liver, salivary and endocrine glands, and gastrointestinal tract were rapidly ...
List of excipients
Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Unopened vial: 3 years. Diluted solution: Chemical and physical in-use stability has been demonstrated for the diluted medicinal product as follows: protected from light in polyethylene or polyvinylchloride ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Store in the original package in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
Clear type I glass vials closed by a grey butyl or black chlorobutyl rubber stopper covered with a crimped-on aluminium ring and a cap. Each vial contains either 2 mL (50 mg vinflunine), 4 mL (100 mg vinflunine) ...
Special precautions for disposal and other handling
General precautions for preparation and administration. Vinflunine is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Javlor. ...
Marketing authorization holder
Pierre Fabre Médicament, 45, place Abel Gance, F-92100 Boulogne, France
Marketing authorization number(s)
EU/1/09/550/001-012
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 September 2009 Date of the latest renewal: 16 May 2014
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