SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, BP SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

SULFAMETHOXAZOLE; TRIMETHOPRIM

Διαθέσιμο από:

JUNO PHARMACEUTICALS CORP.

Φαρμακολογική κατηγορία (ATC):

J01EE01

INN (Διεθνής Όνομα):

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Δοσολογία:

80MG; 16MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

SULFAMETHOXAZOLE 80MG; TRIMETHOPRIM 16MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2022-08-30

Αρχείο Π.Χ.Π.

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