Država: Kanada
Jezik: angleščina
Source: Health Canada
TESTOSTERONE UNDECANOATE
TARO PHARMACEUTICALS INC
G03BA03
TESTOSTERONE
40MG
CAPSULE
TESTOSTERONE UNDECANOATE 40MG
ORAL
10
Schedule G (CDSA IV)
ANDROGENS
Active ingredient group (AIG) number: 0120414001; AHFS:
APPROVED
2014-02-20
_TARO-TESTOSTERONE (TESTOSTERONE UNDECANOATE CAPSULES)_ _40 MG_ _ _ _ _ _ _ _Page 1 of 28_ PRODUCT MONOGRAPH TARO-TESTOSTERONE TESTOSTERONE UNDECANOATE CAPSULES 40 MG ANDROGEN TARO PHARMACEUTICALS INC. DATE OF PREPARATION : 130 East Drive, Brampton October 25, 2018 Ontario L6T 1C1 CONTROL NO: 220849 _TARO-TESTOSTERONE (TESTOSTERONE UNDECANOATE CAPSULES)_ _40 MG_ _ _ _ _ _ _ _Page 2 of 28_ 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................................................................................................. 7 DRUG INTERACTIONS ................................................................................................. 11 DOSAGE AND ADMINISTRATION............................................................................ 11 OVERDOSAGE.......................................................................... ................................. 12 ACTION AND CLINICAL PHARMACOLOGY............................................................ 12 STORAGE AND STABILITY.......................................................................................... 14 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 14 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................... 14 PART II: SCIENTIFIC INFORMATION ................................................................... 15 PHARMACEUTICAL INFORMATION......................................................................... 15 CLINICAL TRIALS............................................... Preberite celoten dokument