PAMIDRONATE DISODIUM FOR INJECTION SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

PAMIDRONATE DISODIUM

Dostopno od:

PFIZER CANADA ULC

Koda artikla:

M05BA03

INN (mednarodno ime):

PAMIDRONIC ACID

Odmerek:

6MG

Farmacevtska oblika:

SOLUTION

Sestava:

PAMIDRONATE DISODIUM 6MG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

10ML

Tip zastaranja:

Prescription

Terapevtsko območje:

BONE RESORPTION INHIBITORS

Povzetek izdelek:

Active ingredient group (AIG) number: 0123608005; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2003-07-09

Lastnosti izdelka

PRODUCT MONOGRAPH
PR
PAMIDRONATE DISODIUM FOR INJECTION
(PAMIDRONATE DISODIUM)
3 MG / ML, 6 MG / ML AND 9 MG / ML
Sterile Solution for Injection
For intravenous infusion only
THERAPEUTIC CLASSIFICATION
Bone Metabolism Regulator
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Submission Control No.: 220092
Date of Revision:
December 11, 2018
_Product Monograph - _
_Pr_
_Pamidronate Disodium for Injection _
_Page 2 of 39 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
3
ADVERSE REACTIONS
.................................................................................................
10
DOSAGE AND ADMINISTRATION
.............................................................................
15
OVERDOSAGE
...............................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
..............................................................................
24
PHARMACEUTICAL INFORMATION
.........................................................................
24
CLINICAL TRIALS
.........................................................................................................
24
DETAILED PHARMACOLOGY
..............................