ODAN-VERNACON SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

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Download Productkenmerken (SPC)
14-10-2015

Werkstoffen:

PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE

Beschikbaar vanaf:

ODAN LABORATORIES LTD

ATC-code:

S01GA55

INN (Algemene Internationale Benaming):

PHENYLEPHRINE, COMBINATIONS

Dosering:

0.5%; 0.125%

farmaceutische vorm:

SOLUTION

Samenstelling:

PHENIRAMINE MALEATE 0.5%; PHENYLEPHRINE HYDROCHLORIDE 0.125%

Toedieningsweg:

OPHTHALMIC

Eenheden in pakket:

15ML

Prescription-type:

OTC

Therapeutisch gebied:

VASOCONSTRICTORS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2015-10-14

Productkenmerken

                                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
2
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.
3
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.
                                
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