DACARBAZINE MEDAC 1000 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Compra

Scarica Foglio illustrativo (PIL)
28-03-2019
Scarica Scheda tecnica (SPC)
02-11-2020

Principio attivo:

DACARBAZINE AS CITRATE

Commercializzato da:

TZAMAL BIO-PHARMA LTD

Codice ATC:

L01AX04

Forma farmaceutica:

POWDER FOR SOLUTION FOR INJ/INF

Composizione:

DACARBAZINE AS CITRATE 1000 MG/VIAL

Via di somministrazione:

I.V

Tipo di ricetta:

Required

Prodotto da:

MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, GERMANY

Area terapeutica:

DACARBAZINE

Indicazioni terapeutiche:

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.

Data dell'autorizzazione:

2015-02-17

Foglio illustrativo

                                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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