MELPHALAN Film-coated tablets (2014)
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Περιεχόμενα
Name of the medicinal product
Melphalan 2 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 2 mg melphalan.
Pharmaceutical form
Film-coated tablets. MELPHALAN are white to off-white film-coated, round, biconvex tablets engraved GX EH3 on one side and A on the other.
Therapeutic indications
Melphalan Tablets are indicated in the treatment of multiple myeloma and advanced ovarian adenocarcinoma. Melphalan either alone or in combination with other drugs has a significant therapeutic effect ...
Posology and method of administration
Since Melphalan is myelosuppressive, frequent blood counts are essential during therapy and the dosage should be delayed or adjusted if necessary (see Special Warnings and Precautions for Use). Oral administration ...
Contraindications
Melphalan should not be given to patients who have suffered a previous hypersensitivity reaction to melphalan.
Special warnings and precautions for use
Melphalan is an active cytotoxic agent for use only under the direction of physicians experienced in the administration of such agents. Immunisation using a live organism vaccine has the potential to cause ...
Interaction with other medicinal products and other forms of interaction
Vaccinations with live organism vaccines are not recommended in immunocompromised individuals (see Warnings and Precautions). Nalidixic acid together with high-dose intravenous melphalan has caused deaths ...
Fertility, pregnancy and lactation
As with all cytotoxic chemotherapy, adequate contraceptive precautions should be advised when either partner is receiving Melphalan. Teratogenicity The teratogenic potential of Melphalan has not been studied. ...
Effects on ability to drive and use machines
Not known.
Undesirable effects
For this product there is no modern clinical documentation which can be used as support for determining the frequency of undesirable effects. Undesirable effects may vary in their incidence depending on ...
Overdose
Symptoms and signs Gastro-intestinal effects, including nausea, vomiting and diarrhoea are the most likely signs of acute oral overdosage. Diarrhoea, sometimes haemorrhagic, has been reported after intravenous ...
Pharmacodynamic properties
Melphalan is a bifunctional alkylating agent. Formation of carbonium intermediates from each of the two bis-2-chlorethyl groups enables alkylation through covalent binding with the 7-nitrogen of guanine ...
Pharmacokinetic properties
Absorption The absorption of oral melphalan is highly variable with respect to both the time to first appearance of the drug in plasma and peak plasma concentration. In studies of the absolute bioavailability ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to that in other sections of the SmPC.
List of excipients
Tablet Core: Microcrystalline cellulose Crospovidone Colloidal anhydrous silica Magnesium stearate Tablet Film Coating: Hypromellose Titanium dioxide Macrogol
Incompatibilities
None known.
Shelf life
Shelf life: 24 months.
Special precautions for storage
Store at 2°C to 8°C.
Nature and contents of container
Supplied in amber glass bottles with a child resistant closure containing 25 or 50 tablets.
Special precautions for disposal and other handling
Safe handling of MELPHALAN tablets The handling of Melphalan tablets should follow guidelines for the handling of cytotoxic drugs according to prevailing local recommendations and/or regulations (for example ...
Marketing authorization holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
PL 39699/0043
Date of first authorization / renewal of the authorization
11 November 2002
Date of revision of the text
January 2014
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