ODAN-VERNACON SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE

Disponible depuis:

ODAN LABORATORIES LTD

Code ATC:

S01GA55

DCI (Dénomination commune internationale):

PHENYLEPHRINE, COMBINATIONS

Dosage:

0.5%; 0.125%

forme pharmaceutique:

SOLUTION

Composition:

PHENIRAMINE MALEATE 0.5%; PHENYLEPHRINE HYDROCHLORIDE 0.125%

Mode d'administration:

OPHTHALMIC

Unités en paquet:

15ML

Type d'ordonnance:

OTC

Domaine thérapeutique:

VASOCONSTRICTORS

Descriptif du produit:

Active ingredient group (AIG) number: 0200771004; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2015-10-14

Résumé des caractéristiques du produit

PRESCRIBING INFORMATION
ODAN-VERNACON
Pheniramine maleate and phenylephrine hydrochloride ophthalmic
solution
ANTIHISTAMINE/DECONGESTANT
ODAN LABORATORIES LTD.
325 Stillview Ave.,
Pointe-Claire, Québec H9R 2Y6
Control No: 188058
Date of Preparation:
October 14, 2015
www.odanlab.com
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PRESCRIBING INFORMATION
ODAN-VERNACON
Pheniramine maleate and phenylephrine hydrochloride ophthalmic
Solution
THERAPEUTIC CLASSIFICATION
Sympathomimetic used as decongestants
CLINICAL PHARMACOLOGY
Application of ODAN-VERNACON (Pheniramine maleate and phenylephnne
hydrochloride) to the
eye produces the decongestant and mydriatic effects of the
vasoconstrictor, phenylephrine
hydrochloride and the anti-allergenic effects of the antihistamine,
phenyramine.
INDICATIONS
ODAN-VERNACON provides prompt, effective relief from ophthalmic
symptoms such as tearing,
itching, redness and swelling in hay fever and other allergies.
CONTRAINDICATIONS
This preparation is contraindicated in persons sensitive to any of its
components.
WARNINGS
For topical ophthalmic use only.
PRECAUTIONS
Caution should be observed if glaucoma is suspected and in
hypertensive or diabetic patients. lf signs
of sensitivity develop, during treatment or if irritation persists or
increases the patient should be
advised to discontinue use and consult physician.
DOSAGE AND ADMINISTRATION
One or two drops instilled into eye(s) every 3 to 4 hours.
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AVAILABILITY
Each mL of sterile ophthalmic solution contains: Pheniramine maleate
0.5%, phenylephrine
hydrochloride 0.125%, and the following non-medicinal ingredients:
Polyvinyl alcohol 1.4%, sodium
phosphate (monobasic), sodium phosphate (dibasic), sodium chloride in
purified water and
benzalkonium chloride 0.0067% as a preservative agent. Supplied as a
sterile solution in 15 mL
plastic dropper bottles.
STORAGE
Store between 15 ºC and 30 ºC.