CAVERJECT STERILE POWDER KIT

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

ALPROSTADIL

Tilgjengelig fra:

PFIZER CANADA ULC

ATC-kode:

G04BE01

INN (International Name):

ALPROSTADIL

Dosering :

20MCG

Legemiddelform:

KIT

Sammensetning:

ALPROSTADIL 20MCG

Administreringsrute:

INTRACAVERNOSAL

Enheter i pakken:

1ML

Resept typen:

Prescription

Terapeutisk område:

MISCELLANEOUS VASODILATATING AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0115288006; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2003-09-09

Preparatomtale

_CAVERJECT STERILE POWDER (alprostadil) Product Monograph _
_Page 1 of 33_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
CAVERJECT® STERILE POWDER
alprostadil for injection
powder, 20 mcg / vial, intracavernosal
Prostaglandin
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Initial Authorization:
SEP 16, 2003
Date of Revision:
DEC 20, 2022
Submission Control Number: 264876
® TM Pfizer Inc.
Pfizer Canada ULC, Licensee
©
Pfizer Canada ULC, 2022
_ _
_CAVERJECT STERILE POWDER (alprostadil) Product Monograph Page 2 of
33_
_ _
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
7 WARNINGS AND PRECAUTIONS, Fertility
12/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.3
Reconstit