TEVA-TERIPARATIDE INJECTION SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

TERIPARATIDE (TERIPARATIDE ACETATE)

Disponibil de la:

TEVA CANADA LIMITED

Codul ATC:

H05AA02

INN (nume internaţional):

TERIPARATIDE

Dozare:

250MCG

Forma farmaceutică:

SOLUTION

Compoziție:

TERIPARATIDE (TERIPARATIDE ACETATE) 250MCG

Calea de administrare:

SUBCUTANEOUS

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

PARATHYROID AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0150152001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2019-08-06

Caracteristicilor produsului

_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
.............................................................