Maa: Kanada
Kieli: englanti
Lähde: Health Canada
TERIPARATIDE (TERIPARATIDE ACETATE)
TEVA CANADA LIMITED
H05AA02
TERIPARATIDE
250MCG
SOLUTION
TERIPARATIDE (TERIPARATIDE ACETATE) 250MCG
SUBCUTANEOUS
15G/50G
Prescription
PARATHYROID AGENTS
Active ingredient group (AIG) number: 0150152001; AHFS:
APPROVED
2019-08-06
_Teva-Teriparatide Injection _ _Page 1 of 61_ PRODUCT MONOGRAPH PR TEVA-TERIPARATIDE INJECTION Sterile Solution for Subcutaneous Injection 250 mcg / mL teriparatide (as teriparatide acetate) Teva Standard Bone Formation Agent Teva Canada Limited 30 Novopharm Court Toronto, ON M1B 2K9 Date of Revision: April 17, 2023 Submission Control No: 269436 _Teva-Teriparatide _ _Page 2 of 61 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 DESCRIPTION....................................................................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................5 ADVERSE REACTIONS ....................................................................................................8 DRUG INTERACTIONS ..................................................................................................12 DOSAGE AND ADMINISTRATION ..............................................................................13 OVERDOSAGE ................................................................................................................14 ACTION AND CLINICAL PHARMACOLOGY ............................................................14 STORAGE AND STABILITY ..........................................................................................18 INSTRUCTIONS FOR PEN USE .....................................................................................19 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................19 PART II: SCIENTIFIC INFORMATION ............................................................. Lue koko asiakirja