METHOTREXATE PF/SA INJECTION SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

METHOTREXATE (METHOTREXATE SODIUM)

Tersedia dari:

SANDOZ CANADA INCORPORATED

Kode ATC:

L01BA01

INN (Nama Internasional):

METHOTREXATE

Dosis:

25MG

Bentuk farmasi:

SOLUTION

Komposisi:

METHOTREXATE (METHOTREXATE SODIUM) 25MG

Rute administrasi :

INTRA-ARTERIAL

Unit dalam paket:

50MG/2ML,500MG/20ML,1000MG/40ML

Jenis Resep:

Prescription

Area terapi:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0107545002; AHFS:

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2018-08-01

Karakteristik produk

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_Methotrexate PF/SA Injection _
_Page 1 of 43_
PRODUCT MONOGRAPH
PR
METHOTREXATE PF/SA INJECTION
methotrexate injection USP
25 mg/mL as
50 mg/2 mL
500 mg/20 mL
1000 mg/40 mL
Antimetabolite and Antirheumatic
Sandoz Canada Inc.
145, Jules-Léger
Boucherville, Quebec
J4B 7K8
Date of Revision:
February 18, 2013
Submission Control No: 159589
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_Methotrexate PF/SA Injection _
_Page 2 of 43_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
15
DOSAGE AND ADMINISTRATION
.............................................................................
17
OVERDOSAGE
................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 27
STORAGE AND STABILITY
.........................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 30
PART II: SCIENTIFIC INFORMATION
...............................................................................
31
PHARMACEUTICAL INFORMATION
.........................................................................
3