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ALKERAN (2014)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Aspen Pharma Trading Limited
Διεύθυνση :
3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
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Δωρεάν εγγραφή

Name of the medicinal product

Alkeran 2 mg Film-coated Tablets.

Qualitative and quantitative composition

Each tablet contains 2 mg melphalan. For a full list of excipients see section 6.1.

Pharmaceutical form

Film-coated tablet White, film-coated round tablet engraved GXEH3 on one side and an A on the other.

Therapeutic indications

Melphalan tablets are indicated in the treatment of: multiple myeloma; advanced ovarian adenocarcinoma. Melphalan tablets may be used in the treatment of: breast carcinoma: melphalan either alone or in ...

Posology and method of administration

Oral administration in adults: The absorption of Alkeran after oral administration is variable. Dosage may need to be cautiously increased until myelosuppression is seen, in order to ensure that potentially ...

Contraindications

Alkeran should not be given to patients who have suffered a previous hypersensitivity reaction to melphalan.

Special warnings and precautions for use

ALKERAN IS AN ACTIVE CYTOTOXIC AGENT FOR USE UNDER THE DIRECTION OF PHYSICIANS EXPERIENCED IN THE ADMINISTRATION OF SUCH AGENTS. Immunisation using a live organism vaccine has the potential to cause infection ...

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

Teratogenicity The teratogenic potential of Alkeran has not been studied. In view of its mutagenic properties and structural similarity to known teratogenic compounds, it is possible that melphalan could ...

Effects on ability to drive and use machines

No data.

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 early signs of acute oral overdosage. Treatment General supportive measures, together with appropriate ...

Pharmacodynamic properties

Group + ATC code: Antineoplastic and Immunomodulating Agents (Nitrogen mustard analogues) L01AA03. Mode of Action: Melphalan is a bifunctional alkylating agent. Formation of carbonium intermediates from ...

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

Melphalan is mutagenic in animals.

List of excipients

Tablet Core: Microcrystalline cellulose Crospovidone Colloidal anhydrous silica Magnesium stearate Tablet film-coating: Hypromellose Titanium Dioxide Macrogol

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

Store in a refrigeration 2°C to 8°C.

Nature and contents of container

Alkeran Tablets are supplied in amber glass bottles of 25 or 50 tablets with a child-resistant closure. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

The handling of Alkeran formulations should follow guidelines for the handling of cytotoxic drugs according to prevailing local recommendations. Pregnant Staff should not handle cytotoxics. Protective ...

Marketing authorization holder

Aspen Pharma Trading Limited 3016 Lake Drive Citywest Business Campus Dublin 24 Ireland

Marketing authorization number(s)

PA 1691/4/2

Date of first authorization / renewal of the authorization

Date of first authorisation: 01 April 1979 Date of last renewal: 01 April 2009

Date of revision of the text

April 2014