DACARBAZINE MEDAC 200 MG
Land: Israel
Språk: engelska
Källa: Ministry of Health
Bipacksedel
(PIL)
28-03-2019
Produktens egenskaper
(SPC)
02-11-2020
Offentlig bedömningsrapport
(PAR)
02-11-2020
Aktiva substanser:
DACARBAZINE AS CITRATE
Tillgänglig från:
TZAMAL BIO-PHARMA LTD
ATC-kod:
L01AX04
Läkemedelsform:
POWDER FOR SOLUTION FOR INJ/INF
Sammansättning:
DACARBAZINE AS CITRATE 200 MG/VIAL
Administreringssätt:
I.V
Receptbelagda typ:
Required
Tillverkad av:
MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, GERMANY
Terapiområde:
DACARBAZINE
Terapeutiska indikationer:
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.
Tillstånd datum:
2015-02-17
Bipacksedel
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
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