ONRELTEA GEL

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

BRIMONIDINE (BRIMONIDINE TARTRATE)

Διαθέσιμο από:

GALDERMA CANADA INC

Φαρμακολογική κατηγορία (ATC):

D11AX21

INN (Διεθνής Όνομα):

BRIMONIDINE

Δοσολογία:

0.33%

Φαρμακοτεχνική μορφή:

GEL

Σύνθεση:

BRIMONIDINE (BRIMONIDINE TARTRATE) 0.33%

Οδός χορήγησης:

TOPICAL

Μονάδες σε πακέτο:

2/10/30G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0155390001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2014-02-26

Αρχείο Π.Χ.Π.

_ _
_ONRELTEA (brimonidine) Product Monograph _
_Page 1 of 22_
PRODUCT MONOGRAPH
PR
ONRELTEA
TM
Brimonidine Gel, 0.33% w/w
(as brimonidine tartrate)
Selective alpha-2 adrenergic agonist
Topical rosacea therapy
Other Dermatologicals, ATC code: D11AX21
GALDERMA CANADA INC.
55 Commerce Valley Dr. W., 4th floor
Thornhill, Ontario L3T 7V9
Date of Preparation:
August 2, 2018
Submission Control No: 215929
_ _
_ONRELTEA (brimonidine) Product Monograph _
_Page 2 of 22_
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
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
..................................................................................................................9
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................11
SPECIAL HANDLING INSTRUCTIONS
.......................................................................11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................11
PART II: SCIENTIFIC INFORMATION
...............................................................................12
PHARMACEUTICAL INFORMATION
........