JAMP-METHOTREXATE SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

METHOTREXATE (METHOTREXATE SODIUM)

Disponible depuis:

JAMP PHARMA CORPORATION

Code ATC:

L01BA01

DCI (Dénomination commune internationale):

METHOTREXATE

Dosage:

25MG

forme pharmaceutique:

SOLUTION

Composition:

METHOTREXATE (METHOTREXATE SODIUM) 25MG

Mode d'administration:

INTRA-ARTERIAL

Unités en paquet:

2ML/40ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2022-11-14

Résumé des caractéristiques du produit

JAMP-METHOTREXATE, METHOTREXATE INJECTION USP, 25 MG/ML UNPRESERVED
PAGE 1 OF 69
PRODUCT MONOGRAPH
Pr
Jamp-METHOTREXATE
Methotrexate Injection USP
Unpreserved
Methotrexate 25 mg/mL
Sterile Solution
ANTIMETABOLITE AND ANTIRHEUMATIC JAMP PHARMA CORPORATION DATE OF REVISION
:
September 25, 2019
1310 rue Nobel
Boucherville, Québec
Canada J4B 5H3
SUBMISSION CONTROL NO.:
230627
JAMP-METHOTREXATE, METHOTREXATE INJECTION USP, 25 MG/ML UNPRESERVED
PAGE 2 OF 46
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
.....................................................................................
19
OVERDOSAGE
......................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 28
STORAGE AND
STABILITY..................................................................................................
30
SPECIAL HANDLING INSTRUCTIONS
.............................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 32
PART II: SCIENTIFIC INFORMATION
.......................................