COSMEGEN POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DACTINOMYCIN

Tersedia dari:

RECORDATI RARE DISEASES CANADA INC

Kode ATC:

L01DA01

INN (Nama Internasional):

DACTINOMYCIN

Dosis:

0.5MG

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

DACTINOMYCIN 0.5MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

0.5MG/VIAL

Jenis Resep:

Prescription

Area terapi:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0105865001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2006-09-06

Karakteristik produk

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_Page 1 of 23_
PRODUCT MONOGRAPH
PR COSMEGEN®
DACTINOMYCIN FOR INJECTION
LYOPHILIZED POWDER FOR INJECTION CONTAINING 500 MCG DACTINOMYCIN/VIAL
ACTINOMYCIN ANTIBIOTIC; ANTINEOPLASTIC
Recordati Rare Diseases Canada Inc.
3080 Yonge Street, Suite 6060
Toronto, ON
M4N 3N1
Control # 217570
Date of Revision:
August 29, 2018
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_Page 2 of 23_
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
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
..............................