AJ-GEMCITABINE POWDER FOR SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

Inapatikana kutoka:

AGILA JAMP CANADA INC

ATC kanuni:

L01BC05

INN (Jina la Kimataifa):

GEMCITABINE

Kipimo:

200MG

Dawa fomu:

POWDER FOR SOLUTION

Tungo:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200MG

Njia ya uendeshaji:

INTRAVENOUS

Vitengo katika mfuko:

10ML

Dawa ya aina:

Prescription

Eneo la matibabu:

ANTINEOPLASTIC AGENTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0133122001; AHFS:

Idhini hali ya:

CANCELLED PRE MARKET

Idhini ya tarehe:

2015-11-03

Tabia za bidhaa

PRODUCT MONOGRAPH
PR
AJ-GEMCITABINE
GEMCITABINE FOR INJECTION, USP
200 MG, 1 G AND 2 G PER VIAL
38 MG/ML GEMCITABINE (AS GEMCITABINE HYDROCHLORIDE)
STERILE LYOPHILIZED POWDER
ANTINEOPLASTIC AGENT
DATE OF PREPARATION:
AGILA JAMP CANADA INC.
1380 – 203 Newton
Boucherville, Québec
Canada J4B 5H2
July 18, 2013
SUBMISSION CONTROL NUMBER: 165924
AJ-GEMCITABINE Product Monograph
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................
20
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
........................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
24
STORAGE AND STABILITY
.................................................................................................
25
DOSAGE FORMS, COMPOSITION AND
PACKAGING..................................................... 26
PART II: SCIENTIFIC INFORMATION
...............................................................................
27
PHARMACEUTICAL INFORMATION
.................................................................................
27
CLINICAL TRIALS
......