METHOTREXATE PF/SA INJECTION SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

METHOTREXATE (METHOTREXATE SODIUM)

Saatavilla:

SANDOZ CANADA INCORPORATED

ATC-koodi:

L01BA01

INN (Kansainvälinen yleisnimi):

METHOTREXATE

Annos:

25MG

Lääkemuoto:

SOLUTION

Koostumus:

METHOTREXATE (METHOTREXATE SODIUM) 25MG

Antoreitti:

INTRA-ARTERIAL

Kpl paketissa:

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

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANTINEOPLASTIC AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2018-08-01

Valmisteyhteenveto

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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