HEMANGIOL SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PROPRANOLOL (PROPRANOLOL HYDROCHLORIDE)

Διαθέσιμο από:

PIERRE FABRE DERMO-COSMETIQUE CANADA INC

Φαρμακολογική κατηγορία (ATC):

C07AA05

INN (Διεθνής Όνομα):

PROPRANOLOL

Δοσολογία:

3.75MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

PROPRANOLOL (PROPRANOLOL HYDROCHLORIDE) 3.75MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

120ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

BETA-ADRENERGIC BLOCKING AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0159470001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2016-09-23

Αρχείο Π.Χ.Π.

_ _
_Product Monograph _
_ _
_HEMANGIOL (propranolol hydrochloride) _
_Page 1 of 48_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr HEMANGIOL
Propranolol solution
Oral solution, 3.75 mg/mL propranolol (as propranolol hydrochloride),
Oral use
Beta blocking agents, non-selective (C07AA05)
Pierre Fabre Dermo-Cosmetique Canada Inc
9955, Avenue de Châteauneuf, Bureau 115
Brossard (Québec), Canada J4Z 3V5
http://www.pierre-fabre.com
Date of Initial Authorization:
SEP 23, 2016
Date of Revision:
JUN 16, 2021
Submission Control Number: 247151
_ _
_Product Monograph _
_ _
_HEMANGIOL (propranolol hydrochloride) _
_Page 2 of 48_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
06/2021
7 WARNINGS AND PRECAUTIONS, General
10/2019
7 WARNINGS AND PRECAUTIONS, Cardiovascular - Cardiac failure
10/2019
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism -
Hypoglycemia
06/2021
7 WARNINGS AND PRECAUTIONS, Reproductive health
06/2021
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
06/2021
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
06/2021
8 ADVERSE REACTIONS, 8.4 Post-Market Adverse Reactions
10/2019
9 DRUG INTERACTIONS, 9.2 Drug Interactions Overview
10/2019
4 DOSAGE AND ADMINISTRATION. 4.3 Administration
10/2019
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics.............................................