Država: Kanada
Jezik: engleski
Izvor: Health Canada
CEFAZOLIN (CEFAZOLIN SODIUM)
PFIZER CANADA ULC
J01DB04
CEFAZOLIN
10G
POWDER FOR SOLUTION
CEFAZOLIN (CEFAZOLIN SODIUM) 10G
INTRAVENOUS
100
Prescription
FIRST GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0109442003; AHFS:
CANCELLED POST MARKET
2019-06-28
PRODUCT MONOGRAPH PR CEFAZOLIN FOR INJECTION USP (IM/IV Use) 500 mg, 1 g and 10 g cefazolin per vial (incorporated as cefazolin sodium) Sterile Powder for Solution Antibiotic Pfizer Canada Inc. 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 Date of revision: November 09, 2018 _ _ _Manufactured by:_ PFIZER HEALTHCARE INDIA PVT. LTD. Irungattukottai - 602 105, India _Distributed by: _ APOTEX INC. 150 Signet Drive Toronto, ON, M9L 1T9 Control No. 220675 _Product Monograph – _ _Pr_ _Cefazolin for Injection USP _ _ _ _Page 2 of 24 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION 3 SUMMARY PRODUCT INFORMATION 3 INDICATIONS AND CLINICAL USE 3 CONTRAINDICATIONS 4 WARNINGS AND PRECAUTIONS 4 ADVERSE REACTIONS 6 DRUG INTERACTIONS 6 DOSAGE AND ADMINISTRATION 6 OVERDOSAGE 11 ACTION AND CLINICAL PHARMACOLOGY 11 STORAGE AND STABILITY 12 SPECIAL HANDLING INSTRUCTIONS 13 DOSAGE FORMS, COMPOSITION AND PACKAGING 13 PART II: SCIENTIFIC INFORMATION 14 PHARMACEUTICAL INFORMATION 14 CLINICAL TRIALS 14 MICROBIOLOGY 15 TOXICOLOGY 16 REFERENCES 18 PART III: PATIENT MEDICATION INFORMATION 21 _Product Monograph – _ _Pr_ _Cefazolin for Injection USP _ _ _ _Page 3 of 24 _ PR CEFAZOLIN FOR INJECTION USP (IM/IV Use) 500 mg, 1 g and 10 g cefazolin per vial (incorporated as cefazolin sodium) Sterile Powder for Solution Antibiotic PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION ROUTE OF ADMINISTRATION DOSAGE FORM / STRENGTH CLINICALLY RELEVANT NONMEDICINAL INGREDIENTS Parenteral (I.V/ I.M) Powder for injection 500 mg, 1 g and 10 g cefazolin per vial The formulation does not contain any nonmedicinal ingredients INDICATIONS AND CLINICAL USE Cefazolin for Injection USP is indicated in the treatment of the following infections when caused by susceptible strains of the listed organisms: RESPIRATORY TRACT INFECTIONS caused by _Streptococcus _ _pneumoniae_ , _Klebsiella_ _pneumoniae_ , _Haemophilus _ _influenzae_ , _Staphylococcus _ _aureus_ (penicillin-sensitive and penicillin-resistant) and group _A beta-haemoly Pročitajte cijeli dokument