SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, BP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SULFAMETHOXAZOLE; TRIMETHOPRIM

Available from:

JUNO PHARMACEUTICALS CORP.

ATC code:

J01EE01

INN (International Name):

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Dosage:

80MG; 16MG

Pharmaceutical form:

SOLUTION

Composition:

SULFAMETHOXAZOLE 80MG; TRIMETHOPRIM 16MG

Administration route:

INTRAVENOUS

Units in package:

100

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0208901005; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-08-30

Summary of Product characteristics

Page 1 of 41
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, BP
sulfamethoxazole (80 mg/mL) + trimethoprim (16 mg/mL)
sterile solution for the preparation of intravenous infusions
ANTIBACTERIAL AGENT
Juno Pharmaceuticals Corp
402-2233 Argentia Road,
Mississauga, ON, L5N 2X7
Control Number: 258006
Date of Preparation: August 18, 2022
Page 2 of 41
TABLE OF CONTENTS
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TABLE OF CONTENTS
...........................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................. 4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics (2 months – 12 years of age)
.............................................................. 5
1.2
Geriatrics
............................................................................................................
5
2
CONTRAINDICATIONS
...............................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..................................................... 6
4
DOSAGE AND ADMINISTRATION
..............................................................................
6
4.1
Dosing Considerations
........................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
.................................................... 6
4.3
Reconstitution
.....................................................................................................
8
4.4
Administration
.....................................................................................................
9
5
OVERDOSAGE
............................................................................................................
9
6
DOSAGE FORMS, STRE