MELPHALAN RAZ 50 MG

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

MELPHALAN AS HYDROCHLORIDE

Disponibil de la:

RAZ PHARMACEUTICS LTD, ISRAEL

Codul ATC:

L01AA03

Forma farmaceutică:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION

Compoziție:

MELPHALAN AS HYDROCHLORIDE 50 MG

Calea de administrare:

I.V

Tip de prescriptie medicala:

Not required

Produs de:

TILLOMED LABORATORIES LIMITED, UK

Zonă Terapeutică:

MELPHALAN

Indicații terapeutice:

For the palliative treatment of multiple myeloma and for the palliation of non resectable epithelial cancer of the ovary.

Data de autorizare:

2020-12-06

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of the medicinal product
MELPHALAN RAZ 50 MG
2. Qualitative and quantitative composition
Each vial of powder contains melphalan hydrochloride equivalent to 50
mg melphalan.
Each vial of solvent contains 10 ml of solvent.
Each ml of the reconstituted solution contains 5 mg melphalan.
Excipient(s) with known effect:
Each vial of solvent contains 0.4243 g ethanol and 6.2148 g propylene
glycol.
Each vial of solvent contains 53.5 mg sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder and solvent for solution for injection/infusion.
Powder: White to pale yellow lyophilized powder/cake.
Solvent: A clear colourless solution
.
4. Clinical particulars
4.1Therapeutic indications
For the palliative treatment of multiple myeloma and for the
palliation of non resectable epithelial cancer of the ovary.
4.2 Posology and method of administration
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.
Since melphalan is myelosuppressive, frequent blood counts are
essential during therapy and the dosage should be
delayed or adjusted if necessary (See section 4.4)
P
osology
P
arenteral administration:
For intravenous administration, it is recommended that MELPHALAN RAZ
50 MG solution is injected slowly into a
fast-running infusion solution via a swabbed injection port.
If direct injection into a fast-running infusion is not appropriate,
MELPHALAN RAZ 50 MG solution may be
administered diluted in an infusion bag.
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.
When further diluted in an infusion solution, MELPHALAN RAZ 50 MG has
reduced stability and the rate of
degradation increases rapidly with rise in temperature. If
administration occurs at a room temperature of
approximately 25°C, the total time from