OCTOSTIM SPRAY

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DESMOPRESSIN ACETATE

Tersedia dari:

FERRING INC

Kode ATC:

H01BA02

INN (Nama Internasional):

DESMOPRESSIN

Dosis:

150MCG

Bentuk farmasi:

SPRAY

Komposisi:

DESMOPRESSIN ACETATE 150MCG

Rute administrasi :

NASAL

Unit dalam paket:

2.5ML

Jenis Resep:

Prescription

Area terapi:

PITUITARY

Ringkasan produk:

Active ingredient group (AIG) number: 0112050007; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2020-07-17

Karakteristik produk

_ _
_Octostim_
_®_
_ Injection and Nasal Spray _
_Page 1 of 29 _
PRODUCT MONOGRAPH
OCTOSTIM
®
Desmopressin Acetate
Injection (15 µg/mL)
Nasal Spray (1.5 mg/mL)
(Each metered dose delivers 150 µg/spray)
USP
Antihemorrhagic
Ferring Inc.
200 Yorkland Blvd., Suite 500
North York, Ontario
M2J 5C1
Date of Revision:
April 12, 2018
Submission Control No: 212397
_ _
_Octostim_
_®_
_Injection_
_ _
_and Nasal Spray _
_Page 2 of 29 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
...........................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................
3
CONTRAINDICATIONS
......................................................................................................
4
WARNINGS AND PRECAUTIONS
.....................................................................................
5
ADVERSE REACTIONS
.......................................................................................................
9
DRUG INTERACTIONS
.....................................................................................................
10
DOSAGE AND ADMINISTRATION
.................................................................................
11
OVERDOSAGE
...................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 12
STORAGE AND STABILITY
.............................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
..........................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 16
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL INFORMAT