PMS-PAMIDRONATE POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PAMIDRONATE DISODIUM

Διαθέσιμο από:

PHARMASCIENCE INC

Φαρμακολογική κατηγορία (ATC):

M05BA03

INN (Διεθνής Όνομα):

PAMIDRONIC ACID

Δοσολογία:

90MG

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

PAMIDRONATE DISODIUM 90MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

10 ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

BONE RESORPTION INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0123608002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2002-09-10

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
PMS-PAMIDRONATE
(Pamidronate disodium for injection, House standard)
15mg/vial, 30 mg/vial, 60 mg/vial and 90 mg/vial
For intravenous infusion only
BONE METABOLISM REGULATOR
PHARMASCIENCE INC
DATE OF REVISION:
6111 Royalmount Ave., Suite 100
March 30, 2017
Montreal, Quebec
H4P 2T4
www.pharmascience.com
CONTROL NO. 200445
_pms-PAMIDRONATE Product Monograph _
_Page 2 of 44_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
3
WARNINGS AND
PRECAUTIONS.......................................................................................
4
ADVERSE
REACTIONS.......................................................................................................
10
DRUG INTERACTIONS
.......................................................................................................
14
DOSAGE AND ADMINISTRATION
...................................................................................
15
OVERDOSAGE
.....................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 20
STORAGE AND
STABILITY...............................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 25
PART II: SCIENTIFIC INFORMATION
................................................................................
26
PHARMACEUTICAL
INFORMATION...............................................................................
26
CLINICAL TRIALS
....................