DACARBAZINE - DACIN 200 MG

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

DACARBAZINE

Dostępny od:

PROPHARM LTD

Kod ATC:

L01AX

Forma farmaceutyczna:

POWDER FOR SOLUTION FOR INJ/INF

Skład:

DACARBAZINE 200 MG/VIAL

Droga podania:

I.V, INTRA-ARTERIAL

Typ recepty:

Required

Wyprodukowano przez:

LIPOMED AG, SWITZERLAND

Grupa terapeutyczna:

OTHER ALKYLATING AGENTS

Wskazania:

For the treatment of metastatic malignant melanoma, Hodgkin's disease as a second line therapy when used in combination with other agents.

Data autoryzacji:

2022-11-30

Charakterystyka produktu

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1.
NAME OF THE MEDICINAL PRODUCT
DACARBAZINE-DACIN
200
mg
2. COMPOSITION
Active substance: Dacarbazine.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Vial containing 200 mg dacarbazine powder for solution for
injection/infusion.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Metastatic, malignant melanoma.
Hodgkin’s disease as a second line therapy when used in combination
with other agents.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Unless specific dosage guidelines for combination therapy have been
specified, the following dosage regimens are to be
followed, particularly for monotherapy: 4 - 5 day cycles of 150 to 250
mg/m2 body surface area/day I.V.
This treatment can be repeated every 21 days. Alternatively, 2.0-4.5
mg/kg/day I.V may be given for 1-10 days. This
regimen can be repeated every 28 days.
DACARBAZINE- DACIN is administered either as an intravenous injection
over approximately one minute or as an
intravenous infusion over 15-30 minutes. If necessary,
DACARBAZINE-DACIN can be given intra-arterially.
COMBINATION CHEMOTHERAPY: generally 4 to 5 day cycles of 100
mg/m2/day, with a 21 day interval between subsequent
cycles starting from the last day of treatment.
For the preparation of the solution for injection/infusion, please
refer to Section 6.4.
Extravasation of DACARBAZINE-DACIN during intravenous administration
can induce tissue damage and severe pain.
4.3. CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in Section 6.1,
•
pregnancy or breastfeeding (see Section 4.6),
•
leukopenia and/or thrombocytopenia,
•
severe liver or kidney diseases.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
It is recommended that dacarbazine should only be administered under
the supervision of a physician specialised in
oncology who has the facilities for regular monitoring of clinical,
biochemical and haematological effects, during and after
therapy.
If symptoms of a liver or kidney functional disorder or symptoms of a