CUROSURF SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PORACTANT ALFA

Available from:

CHIESI FARMACEUTICI S.P.A.

ATC code:

R07AA02

INN (International Name):

NATURAL PHOSPHOLIPIDS

Dosage:

80MG

Pharmaceutical form:

SUSPENSION

Composition:

PORACTANT ALFA 80MG

Administration route:

INTRATRACHEAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

PULMONARY SURFACTANTS

Product summary:

Active ingredient group (AIG) number: 0139601001; AHFS:

Authorization status:

APPROVED

Authorization date:

2001-09-11

Summary of Product characteristics

_Curosurf_
_®_
_ Product Monograph _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
CUROSURF
®
poractant alfa
Suspension, 80 mg surfactant/mL, Intratracheal
Lung Surfactant (Porcine)
MANUFACTURER:
Chiesi Farmaceutici, S.p.A.
26/A Via Palermo
Parma 43122
Italy
IMPORTED AND DISTRIBUTED BY:
Methapharm Inc.
81 Sinclair Boulevard
Brantford, ON, N3S 7X6
Date of Initial Approval:
January 17, 2000
Date of Revision:
July 22, 2021
Submission Control No: 241424
_Curosurf_
_®_
_ Product Monograph _
_Page 2 of 32_
RECENT MAJOR LABEL CHANGES
Indications, Pediatrics (1.0)
06/2021
Serious Warnings and Precautions (3.0)
06/2021
Dosage and Administration, Dosing Considerations (4.1)
06/2021
Dosage and Administration, Administration (4.3)
06/2021
Warnings and Precautions, General (8.0)
06/2021
Warnings and Precautions, Immune (8.0)
06/2021
Warnings and Precautions, Ophthalmologic (8.0)
06/2021
_Curosurf_
_®_
_ Product Monograph _
_Page 3 of 32_
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
................................................................................
2
TABLE OF
CONTENTS.......................................................................................................
3
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 5
1
INDICATIONS
...........................................................................................................
5
1.1
Pediatrics
..........................................................................................................
5
1.2
Geriatrics
..........................................................................................................
5
2
CONTRAINDICATIONS
...........................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.............................................. 6
4
DOSAGE AND ADMINISTRATION
.........................................................................
6
4.1
Dosing
Considerations......................