PENTAMIDINE ISETIONATE FOR INJECTION BP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PENTAMIDINE ISETIONATE

Available from:

PFIZER CANADA ULC

ATC code:

P01CX01

INN (International Name):

PENTAMIDINE ISETHIONATE

Dosage:

300MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

PENTAMIDINE ISETIONATE 300MG

Administration route:

INTRAMUSCULAR

Units in package:

5 VIALS

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTIPROTOZOALS

Product summary:

Active ingredient group (AIG) number: 0152223001; AHFS:

Authorization status:

APPROVED

Authorization date:

2003-02-13

Summary of Product characteristics

_Pr_
_Pentamidine Isetionate for Injection BP – Product Monograph _
_Page 1 of 21_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR PENTAMIDINE ISETIONATE FOR INJECTION BP
(pentamidine isetionate)
Sterile Powder for Solution
300 mg per vial
Antiparasitic Agent
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Initial Authorization:
JUL 4, 1990
Date of Revision:
JAN 31, 2022
Submission Control Number: 255613
_ _
_Pr_
_Pentamidine Isetionate for Injection BP – Product Monograph _
_Page 2 of 21_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
[01/2022]
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.3
Reconsti