SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, BP SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

SULFAMETHOXAZOLE; TRIMETHOPRIM

Disponibil de la:

JUNO PHARMACEUTICALS CORP.

Codul ATC:

J01EE01

INN (nume internaţional):

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Dozare:

80MG; 16MG

Forma farmaceutică:

SOLUTION

Compoziție:

SULFAMETHOXAZOLE 80MG; TRIMETHOPRIM 16MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2022-08-30

Caracteristicilor produsului

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
RECENT MAJOR LABEL CHANGES ..........................................
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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