País: Canadá
Língua: inglês
Origem: Health Canada
PRAVASTATIN SODIUM
PHARMAPAR INC
C10AA03
PRAVASTATIN
20MG
TABLET
PRAVASTATIN SODIUM 20MG
ORAL
100/500
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0122563002; AHFS:
CANCELLED POST MARKET
2022-07-29
_Priva-PRAVASTATIN _ _ _ _Page 1 of 37 _ PRODUCT MONOGRAPH PR PRIVA-PRAVASTATIN Pravastatin Sodium Tablets, USP 10 mg, 20 mg and 40 mg LIPID METABOLISM REGULATOR PHARMAPAR INC. DATE OF PREPARATION: 100-5950, Ch. de la Côte de Liesse September 1, 2015 Mont-Royal Qc, H4T 1E2 Control # 186294 _Priva-PRAVASTATIN _ _ _ _Page 2 of 37 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION................................................................ 3 SUMMARY PRODUCT INFORMATION .................................................................................... 3 INDICATIONS AND CLINICAL USE .......................................................................................... 3 CONTRAINDICATIONS ............................................................................................................... 5 WARNINGS AND PRECAUTIONS .............................................................................................. 5 ADVERSE REACTIONS .............................................................................................................. 10 DRUG INTERACTIONS .............................................................................................................. 13 DOSAGE AND ADMINISTRATION .......................................................................................... 15 OVERDOSAGE ............................................................................................................................ 16 ACTION AND CLINICAL PHARMACOLOGY ........................................................................ 16 STORAGE AND STABILITY ...................................................................................................... 18 DOSAGE FORMS, COMPOSITION AND PACKAGING ......................................................... 18 PART II: SCIENTIFIC INFORMATION ..................................................................................... 19 PHARMACEUTICAL INFORMATION ...................................................................................... 19 C Leia o documento completo