INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo REFRESH Ophthalmic Solution
SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

REFRESH Ophthalmic Solution

COMPOSITION:
REFRESH Ophthalmic Solution contains:
Polyvinyl alcohol         14 mg/mL
Povidone         6 mg/mL
with sodium chloride and purified water

PHARMACOLOGICAL CLASSIFICATION
A. 15.4 Ophthalmic Preparations. Other.

PHARMACOLOGICAL ACTION
REFRESH is a non-preserved unbuffered slightly hypotonic solution of polyvinyl alcohol and povidone. When used in the eye it can extend the tear contact time.

INDICATIONS
REFRESH is indicated for the symptomatic relief of irritated dry eyes and symptoms of dry eyes. May also be used as a comfort trop while wearing hard or soft contact lenses.

CONTRA-INDICATIONS
Sensitivity to the ingredients.

WARNINGS
If irritation increases or persists of more than 24 hours, discontinue use and consult a medical practitioner.

DOSAGE AND DIRECTIONS FOR USE
Ensure that the container is intact before use. To open, twist off the tab. Apply one or two drops in each eye as needed, or as directed. There is no special dosage schedule for the elderly or for children.
In order to avoid contamination, the dropper should not be allowed to touch the eye or any other surface. Use immediately after opening. Do not store opened container. Discard after use.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Irritation is the most frequently reported side-effect with REFRESH. Some patients may experience allergic reaction with the use of REFRESH. There are also reports of corneal trauma, eye trauma and eye pain.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Accidental overdose will not present any hazard.

IDENTIFICATION
Low-density polyethylene single-dose containers with a clear, colourless to slightly yellow solution.

PRESENTATION
Cardboard cartons containing 30 single-use containers per carton.

STORAGE INSTRUCTION
Store unopened container below 25°C.
Do not store opened container. Discard after use.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
Z/15.4/348

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Allergan Pharmaceuticals (Pty) Ltd.
Mount Royal Industrial Park
James Crescent
Halfway House
Johannesburg, South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT
28 October 1992

New addition to this site: December 2006
Source: Pharmaceutical Industry

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2006