GANCICLOVIR FOR INJECTION USP POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

GANCICLOVIR (GANCICLOVIR SODIUM)

Διαθέσιμο από:

AURO PHARMA INC

Φαρμακολογική κατηγορία (ATC):

J05AB06

INN (Διεθνής Όνομα):

GANCICLOVIR

Δοσολογία:

500MG

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

GANCICLOVIR (GANCICLOVIR SODIUM) 500MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

5X10ML VIALS

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

NUCLEOSIDES AND NUCLEOTIDES

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0128037002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2018-01-17

Αρχείο Π.Χ.Π.

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PRODUCT MONOGRAPH
PR
GANCICLOVIR FOR INJECTION USP
ganciclovir (as ganciclovir sodium)
500 mg/vial
Sterile lyophilized powder
Antiviral Agent
AURO PHARMA INC.
Date of Revision:
3700 Steeles Avenue West, Suite # 402
April 20, 2018
Woodbridge, Ontario, L4L 8K8,
Canada
Submission Control No: 215042
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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
...............................................................................................
10
DRUG INTERACTIONS
...............................................................................................
21
DOSAGE AND
ADMINISTRATION………………………………………………….24
OVERDOSAGE
.............................................................................................................
27
ACTION AND CLINICAL
PHARMACOLOGY……………………………………...28
STORAGE AND STABILITY
.......................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
.....................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 29
PART II: SCIENTIFIC INFORMATION
.............................................................................
30
PHARMACEUTICAL INFORMATION
.......................................................................
30
CLINICAL TRIALS
.......................................................................................................
30
DETAILED P