TEVA-TERIPARATIDE INJECTION SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

TERIPARATIDE (TERIPARATIDE ACETATE)

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

H05AA02

INN (Διεθνής Όνομα):

TERIPARATIDE

Δοσολογία:

250MCG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

TERIPARATIDE (TERIPARATIDE ACETATE) 250MCG

Οδός χορήγησης:

SUBCUTANEOUS

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

PARATHYROID AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2019-08-06

Αρχείο Π.Χ.Π.

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