DACARBAZINE MEDAC 200 MG
Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
Gebrauchsinformation
(PIL)
28-03-2019
Fachinformation
(SPC)
02-11-2020
Öffentlichen Beurteilungsberichts
(PAR)
02-11-2020
Wirkstoff:
DACARBAZINE AS CITRATE
Verfügbar ab:
TZAMAL BIO-PHARMA LTD
ATC-Code:
L01AX04
Darreichungsform:
POWDER FOR SOLUTION FOR INJ/INF
Zusammensetzung:
DACARBAZINE AS CITRATE 200 MG/VIAL
Verabreichungsweg:
I.V
Verschreibungstyp:
Required
Hergestellt von:
MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, GERMANY
Therapiebereich:
DACARBAZINE
Anwendungsgebiete:
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.
Berechtigungsdatum:
2015-02-17
Gebrauchsinformation
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=AdversEffectMedic@moh.gov.il
In addition, you may report by sending an e-mail
message to safety@tzamal-medical.co.il
or by visiting the "Contact Us" webpage at:
http://www.tzamal-medical.co.il/69601.html
or by phone: +972-73-7151107
ב"צמ
ןולעה
ובש
םינמוסמ
תורמחהה
תושקובמה
לע
עקר
בוהצ
.
דומע
1
ךותמ
1
BPS-Safety update form SPC-01
Lesen Sie das vollständige Dokument
