HALAVEN Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
HALAVEN 0.44 mg/ml solution for injection.
Qualitative and quantitative composition
One ml contains eribulin mesilate equivalent to 0.44 mg eribulin. Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg eribulin. Each 3 ml vial contains eribulin mesilate equivalent to 1.32 ...
Pharmaceutical form
Solution for injection (injection). Clear, colourless aqueous solution.
Therapeutic indications
HALAVEN is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease (see section ...
Posology and method of administration
HALAVEN should only be administered under the supervision of a qualified physician experienced in the appropriate use of cytotoxic medicinal products. Posology The recommended dose of eribulin as the ready ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Breast-feeding.
Special warnings and precautions for use
Haematology Myelosuppression is dose dependent and primarily manifested as neutropenia (section 4.8). Monitoring of complete blood counts should be performed on all patients prior to each dose of eribulin. ...
Interaction with other medicinal products and other forms of interaction
Eribulin is mainly (up to 70%) eliminated through biliary excretion. The transport protein involved in this process is unknown. Eribulin is not a substrate of breast cancer resistance protein (BCRP), organic ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of eribulin in pregnant women. Eribulin is embryotoxic, foetotoxic, and teratogenic in rats. HALAVEN should not be used during pregnancy unless clearly necessary ...
Effects on ability to drive and use machines
HALAVEN may cause adverse reactions such as tiredness and dizziness which may lead to minor or moderate influence on the ability to drive or use machines. Patients should be advised not to drive or use ...
Undesirable effects
Summary of safety profile The most commonly reported adverse reactions related to HALAVEN, are bone marrow suppression manifested as neutropenia, leucopenia, anaemia, thrombocytopenia with associated infections. ...
Overdose
In one case of overdose the patient inadvertently received 7.6 mg of eribulin (approximately 4 times the planned dose) and subsequently developed a hypersensitivity reaction (Grade 3) on Day 3 and neutropenia ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other antineoplastic agents ATC code: L01XX41 Eribulin mesilate is a microtubule dynamics inhibitor belonging to the halichondrin class of antineoplastic agents. It is a structurally ...
Pharmacokinetic properties
Distribution The pharmacokinetics of eribulin are characterized by a rapid distribution phase followed by a prolonged elimination phase, with a mean terminal half-life of approximately 40 h. It has a large ...
Preclinical safety data
Eribulin was not mutagenic in vitro in the bacterial reverse mutation assay (Ames test). Eribulin was positive in the mouse lymphoma mutagenesis assay and was clastogenic in the in vivo rat micronucleus ...
List of excipients
Ethanol anhydrous Water for injections Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Unopened vials: 5 years. In-use shelf life: From a microbiological point of view unless the method of opening precludes the risk of microbial contamination the product should be used immediately. ...
Special precautions for storage
This medicinal product does not require any special storage conditions. For storage conditions after first opening or dilution of the medicinal product, see section 6.3.
Nature and contents of container
5 ml type I glass vial, with teflon-coated, butyl rubber stopper and flip-off aluminium over seal, containing 2 ml of solution. 5 ml type I glass vial, with teflon-coated, butyl rubber stopper and flip-off ...
Special precautions for disposal and other handling
HALAVEN is a cytotoxic anticancer medicinal product and, as with other toxic compounds, caution should be exercised in its handling. The use of gloves, goggles, and protective clothing is recommended. ...
Marketing authorization holder
Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Germany, e-mail: medinfo_de@eisai.net
Marketing authorization number(s)
EU/1/11/678/001-004
Date of first authorization / renewal of the authorization
Date of first authorisation: 17 March 2011 Date of latest renewal: 19 November 2015
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