MINIMS PHOSPHATE SODIQUE DE PREDNISOLONE Gouttes

Pays: Canada

Langue: français

Source: Health Canada

Ingrédients actifs:

Phosphate sodique de prednisolone

Disponible depuis:

BAUSCH & LOMB INC

Code ATC:

S01BA04

DCI (Dénomination commune internationale):

PREDNISOLONE

Dosage:

0.5%

forme pharmaceutique:

Gouttes

Composition:

Phosphate sodique de prednisolone 0.5%

Mode d'administration:

Ophtalmique

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Domaine thérapeutique:

CORTICOSTEROIDS

Descriptif du produit:

Numéro de groupe d'ingrédients actifs (GIA) :0106288003; AHFS:

Statut de autorisation:

APPROUVÉ

Date de l'autorisation:

2020-12-01

Résumé des caractéristiques du produit

_ _
ENGLISH
FRENCH
PR
MINIMS
® PREDNISOLONE SODIUM
PHOSPHATE
Prednisolone Sodium Phosphate Ophthalmic Solution,
USP
CORTICOSTEROID
PRESCRIBING INFORMATION
PRESENTATION
Single dose clear, colorless, sterile eye drops, available as
0.5% w/v solution. Contains no preservative.
ACTION
MINIMS PREDNISOLONE SODIUM
PHOSPHATE exerts its effect on the anterior segment of
the eye by inhibition of inflammatory response to inciting
agents of mechanical, chemical or immunological nature.
INDICATIONS
Single use of MINIMS PREDNISOLONE SODIUM
PHOSPHATE is indicated in the following noninfectious
inflammatory allergic conditions: allergic, non-purulent
catarrhal, and vernal conjunctivitis; acute iritis; catarrhal
corneal ulcer, cornea injuries; non-purulent blepharitis;
nonspecific superficial keratitis; non-purulent phlyctenular
kerato-conjunctivitis. During the course of therapy, if the
inflammatory reaction does not respond within a
reasonable period, institute other forms of therapy.
CONTRANDICATIONS
•
Viral disease of the cornea and conjunctiva;
tuberculosis of the eye; fungal disease of the eye;
acute purulent untreated infections of the eye,
which like other diseases caused by micro-
organisms, may be masked or enhanced by the
presence of the steroid.
•
Herpes simplex, varicella and vaccinia.
•
Hypersensitivity to any of the components of the
medication.
WARNINGS
The use of corticosteroid ophthalmic drops during
pregnancy or in infants should be avoided.
PRECAUTIONS
Fungal infection must be suspected in any persistent
corneal ulceration where a steroid has been used or is in
use. Increased intraocular pressure may develop following
extended ophthalmic use of corticosteroid. Since increased
intraocular pressure can lead to loss of vision, ophthalmic
administration should be used only under adequate
tonometric supervision in patients known to have
glaucoma or have family history of glaucoma.
As with adrenal corticosteroids, prednisolone sodium
phosphate may mask, activate or enhance infection. If
there is a possibility