OTOMAX OINTMENT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

GENTAMICIN (GENTAMICIN SULFATE); CLOTRIMAZOLE; BETAMETHASONE (BETAMETHASONE VALERATE)

Available from:

INTERVET CANADA CORP

Dosage:

3MG; 10MG; 1.0MG

Pharmaceutical form:

OINTMENT

Composition:

GENTAMICIN (GENTAMICIN SULFATE) 3MG; CLOTRIMAZOLE 10MG; BETAMETHASONE (BETAMETHASONE VALERATE) 1.0MG

Administration route:

OTIC

Units in package:

7.5/12.5/15/30/215G

Prescription type:

Prescription

Therapeutic group:

DOGS

Product summary:

Active ingredient group (AIG) number: 0351081001

Authorization status:

APPROVED

Authorization date:

2009-10-01

Patient Information leaflet

OTOMAX
®
SNDS
PART 1.8 – DRAFT PRODUCT LABELS- MIR#1
DP MANUFACTURING SITE - FRIESOYTHE
Version 04Sep2018
Page 1 of 34
INNER LABEL - 7.5 G AND 15 G TUBES - FRONT PANEL – BILINGUAL –
ANNOTATED
Net : XX g
DIN 00817112
OTOMAX
®
GENTAMICIN SULFATE, BETAMETHASONE VALERATE AND CLOTRIMAZOLE OINTMENT /
ONGUENT DE SULFATE DE GENTAMICINE, VALÉRATE DE BÉTAMÉTHASONE ET
CLOTRIMAZOLE
VETERINARY USE ONLY / USAGE VÉTÉRINAIRE SEULEMENT
Antibiotic, Anti-inflammatory, Antifungal / Antibiotique,
anti-inflammatoire et antifongique
For Otic Use in Dogs Only / Pour usage otique chez le chien seulement
WARNINGS: Keep out of the reach of children. SEE PACKAGE INSERT FOR
COMPLETE
PRODUCT INFORMATION.
MISES
EN
GARDE :
garder
hors
de
la
portée
des
enfants.
VOIR
LA
NOTICE
POUR
L’INFORMATION COMPLÈTE SUR LE PRODUIT.
LOT:
OTOMAX
®
SNDS
PART 1.8 – DRAFT PRODUCT LABELS- MIR#1
DP MANUFACTURING SITE - FRIESOYTHE
Version 04Sep2018
Page 2 of 34
INNER LABEL - 7.5 G AND 15 G TUBES - BACK PANEL - BILINGUAL -
ANNOTATED
See crimp for Lot No. and Expiry date. Voir le repli pour le n° de
lot et la date
d’expiration.
ACTIVE INGREDIENTS: Each gram contains: 3 mg gentamicin (as sulfate)
USP, 1 mg
betamethasone (as valerate) USP and 10 mg clotrimazole USP.
DOSAGE AND ADMINISTRATION: Instill OTOMAX ointment into cleaned
external ear canal
twice daily for 7 days.
– Dogs weighing less than 15 kg: 4 drops per affected ear.
– Dogs weighing 15 kg or more: 8 drops per affected ear.
Massage the external ear carefully to assure proper distribution.
STORAGE: Store between 2° and 30°C.
INGRÉDIENTS ACTIFS : Composition par gramme : 3 mg de gentamicine
(sous forme de
sulfate) USP, 1 mg de bétaméthasone (sous forme de valérate) USP et
10 mg de
clotrimazole USP.
POSOLOGIE ET ADMINISTRATION : Instiller la pommade OTOMAX 2 fois par
jour pendant 7
jours, après avoir nettoyé le conduit auditif.
– Chiens pesant moins de 15 kg : 4 gouttes par oreille malade.
– Chiens pesant 15 kg ou plus : 8 gouttes par oreille malade.
Masser soigneusement l�