NEOSURF SUSPENSION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

PHOSPHOLIPID; SURFACTANT-ASSOCIATED PROTEINS SP-B AND SP-C

Verfügbar ab:

CIPLA LTD

ATC-Code:

R07AA02

INN (Internationale Bezeichnung):

NATURAL PHOSPHOLIPIDS

Dosierung:

27MG; 500MCG

Darreichungsform:

SUSPENSION

Zusammensetzung:

PHOSPHOLIPID 27MG; SURFACTANT-ASSOCIATED PROTEINS SP-B AND SP-C 500MCG

Verabreichungsweg:

INTRATRACHEAL

Einheiten im Paket:

100

Verschreibungstyp:

Ethical

Therapiebereich:

PULMONARY SURFACTANTS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0252489001; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2006-11-20

Fachinformation

_NEOSURF (bovine lipid extract surfactant) Product Monograph _
_Page 1 of 19_
PRODUCT MONOGRAPH
NEOSURF
(bovine lipid extract surfactant)
Suspension for Intratracheal Instillation
27 mg phospholipid/mL
THERAPEUTIC CLASSIFICATION
Lung surfactant (bovine)
Manufactured by:
CIPLA LTD.
Mumbai Central
Mumbai 400 008, India
Distributed by:
BLES Biochemicals Inc.
60 Pacific Court, Unit 8
London, Ontario, Canada N5V 3K4
DATE OF AUTHORIZATION: MARCH 16, 2012
CONTROL NO.: 152500
PR
_NEOSURF (bovine lipid extract surfactant) Product Monograph _
_Page 2 of 19_
TABLE OF CONTENTS
THERAPEUTIC CLASSIFICATION
......................................................................................................
3
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
3
SUMMARY PRODUCT INFORMATION
.............................................................................3
DESCRIPTION
........................................................................................................................3
INDICATIONS AND CLINICAL
USE...................................................................................3
CONTRAINDICATIONS
........................................................................................................3
WARNINGS AND
PRECAUTIONS.......................................................................................4
ADVERSE
REACTIONS.........................................................................................................5
DRUG
INTERACTIONS.........................................................................................................9
DOSAGE AND
ADMINISTRATION.....................................................................................9
OVERDOSAGE
.....................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
.................................................................12
STORAGE AND
STABILITY...........................