Država: Kanada
Jezik: engleski
Izvor: Health Canada
PHOSPHOLIPID; SURFACTANT-ASSOCIATED PROTEINS SP-B AND SP-C
CIPLA LTD
R07AA02
NATURAL PHOSPHOLIPIDS
27MG; 500MCG
SUSPENSION
PHOSPHOLIPID 27MG; SURFACTANT-ASSOCIATED PROTEINS SP-B AND SP-C 500MCG
INTRATRACHEAL
100
Ethical
PULMONARY SURFACTANTS
Active ingredient group (AIG) number: 0252489001; AHFS:
APPROVED
2006-11-20
_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........................... Pročitajte cijeli dokument