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

Logo SOFTWEAR® SALINE Solution
SCHEDULING STATUS:
Schedule 0

PROPRIETARY NAME
(and dosage form):

SOFTWEAR® SALINE Solution

COMPOSITION
Preserve-free isotonic saline solution containing sodium chloride 0.61% m/v and an antimicrobial buffer system (A.B.S.®) consisting of boric acid 0.5% m/v, sodium borate 0.005% m/v and sodium perborate 0.027% m/v (generating up to 0.006% hydrogen peroxide stabilised with phosphonic acid).

PHARMACOLOGICAL CLASSIFICATION
A 34 Other

PHARMACOLOGICAL ACTION
SOFTWEAR® SALINEis an isotonic saline solution.

INDICATIONS
SOFTWEAR SALINE is indicated for the rinsing of lenses after cleaning and disinfection, storing of soft lenses overnight prior to disinfection and for up to 30 days after disinfection, dissolving protein removal tablets, daily lens case cleaning and for heat disinfection of soft lenses.

CONTRA-INDICATIONS
Do not use this product if you are hypersensitive to any of the ingredients.
Do not use SOFTWEAR SALINE with chlorine disinfecting tablets.
SOFTWEAR SALINE is not intended for direct installation into the eye, nor for ingestion.

WARNINGS
Consult your doctor or eye care practitioner before using any eye medication with contact lenses.
PROBLEMS WITH CONTACT LENSES AND LENS CARE PRODUCTS COULD RESULT IN SERIOUS INJURY TO THE EYE. It is essential to follow an eye care practitioner’s directions and all labeling instructions for proper use of lenses and lens care products. EYE PROBLEMS, INCLUDING CORNEAL ULCERS, CAN DEVELOP RAPIDLY AND LEAD TO LOSS OF VISION. THEREFORE, IF EYE DISCOMFORT, EXCESSIVE TEARING, VISION CHANGES, REDNESS OF THE EYE SHOULD BE EXPERIECNED, IMMEDIATELY REMOVE LENES AND PROMPTLY CONTACT AN EYE CARE PRACTITIONER.

DOSAGE AND DIRECTIONS FOR USE
Check that the bottle seal is intact before first use. If already broken, do not use. Sterile until bottle seal is broken.
Follow the instructions for use provided with your lens care system and the advice of your eye care practitioner.

STORAGE
Lenses may be stored in SOFTWEAR SALINE overnight prior to disinfection and for up to 30 days after disinfection. Lenses stored for longer must be re-disinfected before wearing.
SOFTWEAR SALINE is compatible with all soft (hydrophilic) contact lenses and with hard gas permeable lenses.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
The following problems may occur while wearing contact lenses:
• Eye stinging, burning or itching (irritation)
• Excessive watering (tearing of the eyes)
• Unusual eye secretions
• Redness of the eyes
• Reduced sharpness of vision (visual acuity)
• Blurred vision
• Sensitivity to light (photophobia)
• Dry eyes
If any of the above problems are noticed, immediately remove and examine the lenses. If the problem stops and the lenses appear to be undamaged, thoroughly clean, rinse and disinfect the lenses and reinsert them. If the problem continues or a lens appears to be damaged, immediately remove the lenses and consult an eye care practitioner. Do not reinsert a damaged lens.
No finality has been reached on the long-term safety of soft contact lens preparations.

PRECAUTIONS
NEVER allow contact lenses to come into contact with non-sterile water (including tap water) as microbial contamination can occur, which may lead to permanent eye damage.
SOFTWEAR SALINE is not sufficient for lens disinfection.
Always use fresh SOFTWEAR SALINE solution, never re-use the solution.
Note: After inserting the lenses, always empty the lens storage case, rinse and allow to air dry.
Always wash and dry your hands before handling contact lenses.
Always start with the same eye first to avoid confusion.
To avoid physical damage to the eye, do not put SOFTWEAR SALINE into your eyes directly from the bottle.
Use before the expiration date.
Consult your eye care practitioner before changing solutions.
Close the bottle tightly after use.
Never touch the dropper tip of the bottle to any surface including the eye, as this may contaminate the solution.

KNOWN SYMPTOMS OF OVER DOSAGE AND PARTICULARS OF ITS TREATMENT
Not applicable

IDENTIFICATION
Clear, colourless, solution.

PRESENTATION
360 mL multi-dose plastic bottles, sterile until opened.

STORAGE INSTRUCTIONS
Store below 25°C.
Once bottle is opened, discard any remaining solution after 3 months.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
31/34/0616

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
NOVARTIS SOUTH AFRICA (PTY) LTD
72 Steel Road
Spartan, Kempton Park
1619

Tel. 011 929 9111

Distributed by Genop Healthcare

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
25 July 1997

New addition to this site: February 2008
Source: Pharmaceutical Industry

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