SYNALAR OINTMENT

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

FLUOCINOLONE ACETONIDE

Pieejams no:

BAUSCH HEALTH, CANADA INC.

ATĶ kods:

D07AC04

SNN (starptautisko nepatentēto nosaukumu):

FLUOCINOLONE ACETONIDE

Deva:

0.025%

Zāļu forma:

OINTMENT

Kompozīcija:

FLUOCINOLONE ACETONIDE 0.025%

Ievadīšanas:

TOPICAL

Vienības iepakojumā:

60G

Receptes veids:

Prescription

Ārstniecības joma:

ANTI-INFLAMMATORY AGENTS

Produktu pārskats:

Active ingredient group (AIG) number: 0106314001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

1998-09-02

Produkta apraksts

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SYNALAR
®
Fluocinolone Acetonide
Ointment 0.025% w/w
TOPICAL CORTICOSTEROID
BAUSCH HEALTH, CANADA INC.
Date of Initial Approval:
2150 St-Elzear Blvd. West
November 17, 2014
Laval, Quebec
H7L 4A8
DATE OF REVISION:
June 25, 2021
Control #: 247002
_Pr_
_SYNALAR _
_®_
_ Page 2 of 13 _
_(Fluocinolone Acetonide) _
RECENT MAJOR LABEL CHANGES
Not applicable
TABLE OF CONTENTS
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................3
1
INDICATIONS
...........................................................................................................3
1.1
Pediatrics……………………………………………………………………………....3
1.2
Geriatrics……………………………………………………………………………....3
2
CONTRAINDICATIONS
...........................................................................................3
3
DOSAGE AND
ADMINISTRATION.........................................................................3
3.1 Dosing Considerations
…………………………………….…………………………..3
3.2 Recommended Dose and Dosage Adjustment
....................................................... ..3
3.3Administration…………………………………………………………………………3
4
OVERDOSAGE
..........................................................................................................4
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...............4
6
WARNINGS AND PRECAUTIONS
..........................................................................4
7
ADVERSE REACTIONS
...........................................................................................5
8
DRUG
INTERACTIONS………………………………………………………………..5
9 CLINICAL PHARMACOLOGY
..............................................................................5
9.1
Pharmacokinetics.............