DACARBAZINE MEDAC 1000 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DACARBAZINE AS CITRATE

Available from:

TZAMAL BIO-PHARMA LTD

ATC code:

L01AX04

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJ/INF

Composition:

DACARBAZINE AS CITRATE 1000 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, GERMANY

Therapeutic group:

DACARBAZINE

Therapeutic area:

DACARBAZINE

Therapeutic indications:

Decarbazine is indicated for the treatment of patients with metastatic malignant melanoma. Further indications for dacarbazine as part of a combination chemotherapy in advanced Hodgkin's disease as a second line.

Authorization date:

2021-06-30

Patient Information leaflet

העדוה
לע
הרמחה
(
עדימ
ןולעב )תוחיטב
אפורל
ךיראת
רושיא
ןולעה :
27.11.2016
םש
רישכתה
תילגנאב
רפסמו
םושירה
DACARBAZINE MEDAC 200 MG (31170)
DACARBAZINE MEDAC 500 MG (31171)
DACARBAZINE MEDAC 1000 MG (31172)
םש
לעב
םושירה
TZAMAL BIO-PHARMA LTD
.
!דבלב תורמחהה טורפל דעוימ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
ADVERSE EVENTS
---
Infections and infestations
Uncommon (>1/1,000, <1/100)
Infections
Reporting suspected adverse reactions after
authorisation of the medicinal
product is important. It
allows continued monitoring of the benefit/risk balance of
the medicinal product.
Any suspected adverse events should be reported to the
Ministry of Health according to the National Regulation
by using an online form at the following link
:
https://forms.gov.il/globaldata/getsequence/getsequence.
spx?formType=[e-mail]
In addition, you may report by sending an e-mail
message to [e-mail]
or by visiting the "Contact Us" webpage at:
http://www.tzamal-medical.co.il/69601.html
or by phone: [phone]
ב"צמ
ןולעה
ובש
םינמוסמ
תורמחהה
תושקובמה
לע
עקר
בוהצ
.
דומע
1
ךותמ
1
BPS-Safety update form SPC-01

Summary of Product characteristics

Page 1 of 8
PRESCRIBING INFORMATION
DACARBAZINE MEDAC 500 MG / 1000 MG
1. NAME OF THE MEDICINAL PRODUCT
Dacarbazine medac 500 mg
Dacarbazine medac 1000 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-dose vial of Dacarbazine medac 500 mg contains 500 mg
dacarbazine (as dacarbazine
citrate, formed in situ). After reconstitution and final dilution
Dacarbazine medac 500 mg contains 1.4 –
2.0 mg/ml dacarbazine.
Each single-dose vial of Dacarbazine medac 1000 mg contains 1000 mg
dacarbazine (as dacarbazine
citrate, formed in situ). After reconstitution and final dilution
Dacarbazine medac 1000 mg contains 2.8 -
4.0 mg/ml dacarbazine.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Dacarbazine medac 500 mg / 1000 mg: Powder for solution for
injection/infusion.
Dacarbazine medac is a white or pale-yellow powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dacarbazine
is indicated for the treatment of patients with metastatic malignant
melanoma.
Further indication for dacarbazine as part of a combination
chemotherapy in advanced Hodgkin’s disease,
as a second line.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
The use of dacarbazine should be confined to physicians experienced in
oncology or haematology.
Dacarbazine is sensitive to light exposure. All reconstituted
solutions should be suitably protected from light
also during administration (light-resistant infusion set).
Care should be taken when administering the injection to avoid
extravasation into tissues since this will cause
local pain and tissue damage. If extravasation occurs, the injection
should be discontinued immediately, and
any remaining portion of the dose should be introduced into another
vein.
The following regimes may be used. For further details see current
scientific literature.
_Malignant melanoma _
Dacarbazine can be administered as single agent in doses of 200 to 250
mg/m² body surface area/day as
an i.v. injection for 5 days every 3 weeks.
As an alternative to an intravenous bolus injectio