Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
DINOPROST (DINOPROST TROMETHAMINE)
PFIZER CANADA ULC
G02AD01
DINOPROST
5MG
SOLUTION
DINOPROST (DINOPROST TROMETHAMINE) 5MG
INTRA-AMNIOTIC
1ML
Prescription
OXYTOCICS
Active ingredient group (AIG) number: 0131402001; AHFS:
CANCELLED POST MARKET
2018-09-30
PRODUCT MONOGRAPH PR PROSTIN ® F 2α (Dinoprost Tromethamine, USP) Sterile solution for injection 5 mg/mL PROSTAGLANDIN Pfizer Canada Inc. Date of Preparation: 17,300 Trans-Canada Highway 25 September 2003 Kirkland, Quebec H9J 2M5 Date of Revision: 06 November 2014 Control No.175411 ® TM Pfizer Enterprises, SARL Pfizer Canada Inc., Licensee © Pfizer Canada Inc. 2014 _Prostin_ _ F_ 2α _ (dinoprost tromethamine)_ _ Product Monograph _ _Page 2 of 19_ _ _ _`_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ................................................................................ 3 INDICATIONS AND CLINICAL USE ...................................................................................... 3 CONTRAINDICATIONS ........................................................................................................... 3 WARNINGS AND PRECAUTIONS .......................................................................................... 4 ADVERSE REACTIONS ........................................................................................................... 5 DRUG INTERACTIONS ............................................................................................................ 8 DOSAGE AND ADMINISTRATION ........................................................................................ 8 OVERDOSAGE .......................................................................................................................... 9 ACTION AND CLINICAL PHARMACOLOGY ..................................................................... 10 STORAGE AND STABILITY .................................................................................................. 10 SPECIAL HANDLING INSTRUCTIONS................................................................................ 10 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................... 10 PART II: SCIENTIFIC INFORMATION ......... Baca dokumen lengkap