COMBIVENT UDV SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

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

Διαθέσιμο από:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Φαρμακολογική κατηγορία (ATC):

R03AL02

INN (Διεθνής Όνομα):

SALBUTAMOL AND IPRATROPIUM BROMIDE

Δοσολογία:

0.5MG; 2.5MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

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

Οδός χορήγησης:

INHALATION

Μονάδες σε πακέτο:

2.5 X 20ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTIMUSCARINICS ANTISPASMODICS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2020-01-08

Αρχείο Π.Χ.Π.

_COMBIVENT UDV Product Monograph Draft-Nov 5, 2015 _
_Page 1 of 39 _
PRODUCT MONOGRAPH
PR
COMBIVENT
® UDV
Ipratropium Bromide (as Monohydrate) and Salbutamol (as Salbutamol
Sulfate)
Nebulizer Solution
Each Unit Dose Vial (UDV) contains 0.50 mg of ipratropium bromide (as
ipratropium bromide
monohydrate) and 2.5 mg salbutamol (as salbutamol sulfate) in 2.5 mL
of saline
BRONCHODILATOR
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road
Burlington, Ontario
L7L 5H4
Submission Control No: 186512
CCDS 0204-05
Date of Revision:
November 25, 2015
Combivent
®
is a registered trademark used under license by Boehringer Ingelheim
(Canada) Ltd.
_ _
_ COMBIVENT UDV Product Monograph Draft-Nov 5, 2015 _
_Page 2 of 39 _
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
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22