MELPHALAN Powder and solvent for solution for injection/infusion (2018)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Melphalan 50 mg powder and solvent for solution for injection/infusion.

Qualitative and quantitative composition

Each vial of powder contains melphalan hydrochloride equivalent to 50 mg melphalan. After reconstitution with 10 ml of the solvent, the resultant solution contains 5 mg/ml melphalan. Excipient with known ...

Pharmaceutical form

Powder and solvent for solution for injection/infusion. Powder: a white to off-white freeze-dried powder or cake. Solvent: a clear colourless liquid/ solution. The pH of the reconstituted solution is 6.5. ...

Therapeutic indications

Melphalan, at conventional intravenous dosage, is indicated in the treatment of multiple myeloma and advanced ovarian cancer. Melphalan, at high intravenous dosage, is indicated, with or without haematopoietic ...

Posology and method of administration

Treatment with melphalan should be supervised by a physician experienced in the use of anticancer therapies. General information Melphalan is for intravenous use and regional arterial perfusion only. Melphalan ...

Contraindications

hypersensitivity to the active substance or any of the excipients listed in section 6.1. breastfeeding.

Special warnings and precautions for use

Melphalan is a cytotoxic drug, which falls into the general class of alkylating agents. It should be prescribed only by physicians experienced in the management of malignant disease with such agents. As ...

Interaction with other medicinal products and other forms of interaction

Vaccinations with live organism vaccines are not recommended in immunocompromised individuals (see section 4.4). Nalidixic acid together with high-dose intravenous melphalan has caused deaths in children ...

Fertility, pregnancy and lactation

Contraception for men and women of childbearing potential As with all cytotoxic treatments, male and female patients who use Melphalan should use effective and reliable contraceptive methods up until three ...

Effects on ability to drive and use machines

There are no data regarding the effect of melphalan treatment on the ability to drive and use machines. Based on the pharmacological profile such an effect is not anticipated. When advising patients treated ...

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. The immediate effects of acute intravenous overdosage are nausea ...

Pharmacodynamic properties

Pharmacotherapeutic group: antineoplastic and immunomodulating agents, antineplastic agents, alkalating agents, nitrogen mustard analogues ATC code: L01AA03 Mechanism of action Melphalan is a bifunctional ...

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

Mutagenicity Melphalan is a cytostatic agent and mutagenicity has therefore not been thoroughly investigated in pre-clinical studies. Melphalan was mutagenic in vivo causing chromosomal aberrations. Clinical ...

List of excipients

Powder: Hydrochloric acid Povidone Solvent: Water for injection Sodium citrate Propylene glycol Ethanol

Incompatibilities

Melphalan is not compatible with infusion solutions containing dextrose, and it is recommended that ONLY Sodium Chloride Intravenous Infusion 0.9% w/v is used.

Shelf life

Shelf life: 2 years. Chemical and physical in use stability have been demonstrated for 1 hour at room temperature. From a microbiological point of view, the product should be used immediately. If not used ...

Special precautions for storage

Do not store above 30°C. Do not refrigerate. Keep the vial in the outer carton in order to protect from light.

Nature and contents of container

Powder: Clear, glass vial with a bromobutyl rubber stopper and aluminium collar with a plastic flip-top cover. Pack size: one vial containing 50 mg melphalan. Solvent: Clear, glass vial with a bromobutyl ...

Special precautions for disposal and other handling

Safe Handling of Melphalan: Melphalan should be prepared for administration by a trained professional who is familiar with its properties and safe handling requirements. Refer to local cytotoxic guidelines ...

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands

Marketing authorization number(s)

PL 31750/0136

Date of first authorization / renewal of the authorization

09/05/2018

Date of revision of the text

09/05/2018

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