APO-SALVENT-IPRAVENT STERULES SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

IPRATROPIUM BROMIDE (IPRATROPIUM BROMIDE MONOHYDRATE); SALBUTAMOL (SALBUTAMOL SULFATE)

Tersedia dari:

APOTEX INC

Kode ATC:

R03AL02

INN (Nama Internasional):

SALBUTAMOL AND IPRATROPIUM BROMIDE

Dosis:

0.5MG; 2.5MG

Bentuk farmasi:

SOLUTION

Komposisi:

IPRATROPIUM BROMIDE (IPRATROPIUM BROMIDE MONOHYDRATE) 0.5MG; SALBUTAMOL (SALBUTAMOL SULFATE) 2.5MG

Rute administrasi :

INHALATION

Unit dalam paket:

20X2.5ML

Jenis Resep:

Prescription

Area terapi:

ANTIMUSCARINICS ANTISPASMODICS

Ringkasan produk:

Active ingredient group (AIG) number: 0232902001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2005-03-31

Karakteristik produk

Page
1
of
40
PRODUCT MONOGRAPH
PR
APO-SALVENT IPRAVENT STERULES
Salbutamol Sulfate and Ipratropium Bromide Inhalation Solution
Each sterule contains 3 mg salbutamol sulfate [2.5 mg salbutamol base]
and 0.5 mg of
ipratropium bromide anhydrous [as monohydrate] in 2.5 mL of saline
BRONCHODILATOR
APOTEX INC.
DATE OF REVISION:
150 Signet Drive
June 22, 2018
Toronto, Ontario M9L 1T9
Control No. 215519
Page
2
of
40
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 ...........................................................................................................
8
DRUG INTERACTIONS .........................................................................................................
13
DOSAGE AND ADMINISTRATION .....................................................................................
14
OVERDOSAGE .......................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY ...................................................................
16
STORAGE AND STABILITY .................................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 22
PART II: SCIENTIFIC INFORMATION
...........................................................................
23
PHARMACEUTICAL INFORMATION .................................................................................
23
C