ZOLEDRONIC ACID INJECTION SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Dostopno od:

TEVA CANADA LIMITED

Koda artikla:

M05BA08

INN (mednarodno ime):

ZOLEDRONIC ACID

Odmerek:

5MG

Farmacevtska oblika:

SOLUTION

Sestava:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5MG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

100ML

Tip zastaranja:

Prescription

Terapevtsko območje:

BONE RESORPTION INHIBITORS

Povzetek izdelek:

Active ingredient group (AIG) number: 0141761003; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2019-08-08

Lastnosti izdelka

1
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID INJECTION
(zoledronic acid injection)
5 mg/100 mL solution for intravenous infusion
Bone Metabolism Regulator
Teva Canada Limited
30 Novopharm Court,
Toronto, Ontario
M1B 2K9
DATE OF REVISION:
July 10, 2017
CONTROL NUMBER: 205639
2
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
.........................................................................................................
11
DRUG INTERACTIONS
.........................................................................................................
25
DOSAGE AND ADMINISTRATION
.....................................................................................
27
OVERDOSAGE
.......................................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 29
STORAGE AND STABILITY
.................................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 33
PART II: SCIENTIFIC INFORMATION
...............................................................................
34
PHARMACEUTICAL INFORMATION
.................................................................................
34
CLINICAL TRIALS
.......