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

Logo SOLO-CARE® Soft solution

SCHEDULING STATUS:
Schedule 0

PROPRIETARY NAME
(and dosage form):

SOLO-CARE® Soft solution

COMPOSITION
Each 1 mL contains
polyhexanide 0.001 mg as the active ingredient and preservative, sodium chloride, poloxamer 407, disodium hydrogen phosphate, disodium edetate and sodium dihydrogen phosphate.
Stabiliser: disodium edentate 0.025% m/v

PHARMACOLOGICAL CLASSIFICATION
A 34 Other (Contact lens solutions)

DESCRIPTION
SOLO-care soft
All-in-one solution loosens and removes accumulation of film, protein deposits and debris from the surface of soft (hydrophilic) contact lenses during cleaning.

INDICATIONS
SOLO-care soft
is indicated for protein removal, cleaning, rinsing, disinfecting, and storing of all types of soft (hydrophilic) contact lenses, including daily wear, flexible wear and extended wear.

CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients. SOLO-care soft is not intended for direct installation into the eyes, nor for ingestion. SOLO-care soft must not be used for hard lenses.

WARNINGS
Consult you eye care practitioner or doctor before using any eye medication or eye drops with contact lenses.
Always use fresh SOLO-care soft solution, never re-use solutions.
Do not mix with other fluids except as directed. Never use tap water with contact lenses.
Problems with soft contact lenses and lens care products could result in serious injury to the eye. Serious damage to the eye and loss of vision may result from wearing contaminated or damaged contact lenses. Proper use and care of contact lenses and lens care products, including lens cases, are essential for the safe use of these products.
If any eye discomfort, watering, vision change, or redness of the eye is experienced, remove lenses immediately and consult your eye care practitioner.

DOSAGE AND DIRECTIONS FOR USE
Clean and disinfect daily of lenses are worn on a daily wear basis or whenever lenses are removed if being worn on an extended wear basis. Always clean and rinse one lens at a time.

DIRECTIONS FOR USE
CLEANING AND DISINFECTING
Always wash your hands thoroughly and dry them with a clean towel before handling the lenses. Always start with the same eye to avoid confusion!
Open lens case.
Remove the lens from one eye and place it in the palm of your hand.
Apply at least three drops of SOLO-care soft to each lens surface.
Gently rub the lens using a backward and forward motion for ten seconds per lens side.
Rinse the lens thoroughly with SOLO-care soft while rubbing the lens gently between thumb and forefinger.
Place the lens in one side of the lens case and fill with fresh SOLO-care soft.
Replace cap and screw closed. Repeat procedure with your other lens.
Allow the lenses to soak at least 10 minutes or overnight.
Your lenses are now clean and disinfected and may be inserted directly into your eyes.
RINSING
SOLO-care soft may be used to rinse the lenses prior to insertion if desired, or if recommended by your eye care practitioner. Rinse the empty lens care case and the lids with fresh SOLO-care soft or sterile saline and leave the case open to air dry.

STORAGE
Lenses may be stored for up to 30 days in SOLO-care soft solution after cleaning and disinfecting. If stored for longer than 30 days the lenses must be cleaned and disinfected again before wearing.

ENZYME CLEANING
SOLO-care soft solution may be used in place of saline to dissolve the enzyme tablets. The enzyme manufactures instructions should be followed.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
The following problems may occur with contact lens wear:
Stinging, burning or itching (irritation) of eyes
Excessive watering (tearing) of the eyes
Unusual eye secretions
Red eyes
Reduced sharpness of vision (visual acuity)
Blurred vision or halos around objects
Sensitivity to light
Dry eyes
If you experience any of the above signs, immediately remove and examine your lens. If a lens appears to be damaged. DO NOT put the lens back on the eye. CONSULT AN EYE CARE PRACTITIONER.
If after the removal of the lens the problem stops and the lenses appear to be undamaged, thoroughly clean, rinse and disinfect the lenses with SOLO-care soft and then reinsert them. If the situation continues, immediately remove your lenses. Promptly consult your eye care practitioner for identification of the problem and necessary treatment to avoid serious eye damage.

PRECAUTIONS
ALWAYS USE SOLO-care soft COMPONENTS. DO NOT SUBSTITUTE WITH COMPONENTS FROM ANY OTHER LENS CARE SYSTEM. Once the bottle is opened, discard any remaining solution after 3 months. Consult your eye care practitioner before changing lens care solutions. Never touch the tip of the bottle to any surface, as this may contaminate the solution. After inserting your lenses into the eyes, always empty your lens storage case, rinse the empty lens case and lids with fresh SOLO-care soft or sterile saline and leave case open to air dry. Keep bottle tightly closed when not in use. Replace contact lens case with every new bottle of SOLO-care soft. Never re-use solution in the lens case. Never use SOLO-care soft for heat disinfection.

KNOWN SYMPTOMS OF OVER DOSAGE AND PARTICULARS OF ITS TREATMENT
Treatment is symptomatic if ingested accidentally.

IDENTIFICATION
Clear, colourless, particle free, slightly opalescent solution.

PRESENTATION
60 mL, 120 mL, 250 mL, or 360 mL multi-dose plastic bottles, sterile until opened. A disposable lens case is included with each bottle.

STORAGE INSTRUCTIONS
Store below 25°C. Protect from light. Keep out of reach of children.

REGISTRATION NUMBER:
35/34/0292

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
7 January 2002

Updated on this site: September 2009
Source: Pharmaceutical Industry

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