MINIMS PHENYLEPHRINE HYDROCHLORIDE SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

PHENYLEPHRINE HYDROCHLORIDE

Dostępny od:

BAUSCH & LOMB INC

Kod ATC:

S01FB01

INN (International Nazwa):

PHENYLEPHRINE

Dawkowanie:

10%

Forma farmaceutyczna:

SOLUTION

Skład:

PHENYLEPHRINE HYDROCHLORIDE 10%

Droga podania:

OPHTHALMIC

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Prescription

Dziedzina terapeutyczna:

MYDRIATICS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0100662005; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2020-12-03

Charakterystyka produktu

Bausch Health, Canada Inc.
MINIMS PHENYLEPHRINE HYDROCHLORIDE
_RA Last revised: December 1, 2020 (CYP) _
ENGLISH
FRENCH
MINIMS
 PHENYLEPHRINE
HYDROCHLORIDE 2.5 %
Phenylephrine Hydrochloride Ophthalmic Solution
PR
MINIMS
 PHENYLEPHRINE
HYDROCHLORIDE 10 %
Phenylephrine Hydrochloride Ophthalmic Solution
PRESCRIBING INFORMATION
MINIMS
MD CHLORHYDRATE DE
PHENYLEPHRINE 2.5 %
Solution ophthalmique de chlorhydrate de phényléphrine
PR
MINIMS
MD CHLORHYDRATE DE
PHENYLEPHRINE 10 %
Solution ophthalmique de chlorhydrate de phényléphrine
RENSEIGNEMENTS POSOLOGIQUES
PRESENTATION
Single dose clear, colourless, sterile eye drops. Two strengths
are available: Phenylephrine Hydrochloride BP 2.5% and 10%
w/v solutions, containing stabilizing agents: EDTA 0.05 w/v,
Sodium Metabisulfite 0.1 %, Purified Water.
USES
Phenylephrine is a directly acting sympathomimetic agent used
topically in the eye as a mydriatic. It may be indicated to dilate
the pupil in diagnostic or therapeutic procedures.
DOSAGE AND ADMINISTRATION
ADULTS
Apply one drop to each eye. If necessary, this dose may be
repeated once only, at least one hour after the first drop.
N.B. The use of a drop of topical anaesthetic a few minutes
before instillation of phenylephrine is recommended to prevent
stinging.
CHILDREN AND THE ELDERLY
The use of phenylephrine 10% solution is contraindicated in
these groups because of the increased risks of systemic toxicity.
Each Minims unit should be discarded after a single use.
CONTRANDICATIONS, WARNINGS ETC.
CONTRANDICATIONS
I.
Patients with cardiac disease, hypertension, aneurysms,
thyrotoxicosis, long-standing insulin-dependent
diabetes and tachycardia.
II.
Patients on monoamine oxidase inhibitors, tricyclic
antidepressants and anti-hypertensive agents (including
betablockers).
III.
Patients with closed angle glaucoma (unless previously
treated with iridectomy) and patients with a narrow
angle prone to glaucoma precipitated by mydriatics.
IV.
Hypersensitivity to phenylephrine or any component of
PRESENTATION
Collyres stérile