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MELPHALAN Film-coated tablets (2014)

Αναφορές

Βιβλιογραφική αναφορά

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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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