ARZI-200 Lyophilized Injection 200 mg/vial

Țară: Tanzania

Limbă: engleză

Sursă: Tanzania Medicinces & Medical Devices Authority

Ingredient activ:

Dacarbazine

Disponibil de la:

MIRACALUS PHARMA PRIVATE LIMITED, INDIA

Codul ATC:

Alkylating agents list

INN (nume internaţional):

Dacarbazine

Dozare:

200 mg/vial

Forma farmaceutică:

Lyophilized Injection

Produs de:

Naprod Life Sciences Private Limited, INDIA

Rezumat produs:

Physical description: A white to yellowish white lyophilized mass; Local technical representative: JILICHEM (T) Limited (5053)

Statutul autorizaţiei:

Registered/Compliant

Data de autorizare:

2020-12-24

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE FINISHED PHARMACEUTICAL PRODUCT:
DACARBAZINE FOR INJECTION USP 200MG/VIAL
ATC CODE: L01AX04 DISTRIBUTION CATEGORY: POM
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each vial contains:
Dacarbazine USP
200mg
EXCIPIENTS: FOR A FULL LIST OF EXCIPIENTS, SEE SECTION 6.1
3.
PHARMACEUTICAL FORM:
Lyophilized powder for Injection DESCRIPTION: A white to yellowish lyophilized mass.
4.
CLINICAL PARTICULARS:
4.1
THERAPEUTIC INDICATIONS
Dacarbazine is indicated for the treatment of patients with
metastasized malignant
melanoma.
Further indications for dacarbazine as part of a combination
chemotherapy are:
-
advanced Hodgkin's disease,
-
advanced adult soft tissue sarcomas (except mesothelioma, Kaposi
sarcoma).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
MALIGNANT MELANOMA
The recommended dosage is 2 to 4.5 mg/kg/day for 10 days. Treatment
may be
repeated at 4-week intervals.
An alternate recommended dosage is 250 mg/square meter body
surface/day I.V injection
for 5 days. Treatment may be repeated every 3 weeks.
HODGKIN'S DISEASE
The
recommended
dosage
of
dacarbazine
in the
treatment
of
Hodgkin's
disease
is 150
mg/square meter body surface/day for 5 days, in combination with
other effective drugs.
Treatment may be repeated every 4 weeks. An alternative recommended
dosage is 375
mg/square meter body surface on day 1, in combination with other
effective drugs, to be
repeated every 15 days.
4.3 CONTRAINDICATIONS
Dacarbazine is contraindicated in patients: -
•
who have a history of hypersensitivity reactions to dacarbazine or to
any of the
excipients.
•
in pregnant or breastfeeding women
•
in patients with leucopenia and/or thrombocytopenia
•
in patients with severe liver or kidney diseases.
4.4
WARNING AND PRECAUTIONS
It is recommended that dacarbazine should only be administered under
the supervision of a
physician specialized in oncology, having the facilities for regular
monitoring of clinical,
biochemical and hematological effects, during and after therapy.
If symptoms of