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

Logo COMPLETE ALL-IN-ONE Solution

SCHEDULING STATUS:
Schedule 0

PROPRIETARY NAME
(and dosage form):

COMPLETE ALL-IN-ONE Solution

COMPOSITION:
COMPLETE ALL-IN-ONE Solution contains:
Polyhexamethylene biguanide 0,001 mg/mL
Other ingredients: poloxamer, phosphate buffer, edetate disodium, sodium chloride, potassium chloride and purified water

PHARMACOLOGICAL CLASSIFICATION
A. 34 Other (Contact Lens Solutions)

PHARMACOLOGICAL ACTION
Polyhexamethylene biguanide solution cleans, loosens and removes accumulations of film, deposits and debris from soft contact lenses. It destroys harmful micro-organisms on the surface of the lens, rinses, stores and wets lenses before insertion.

INDICATIONS
COMPLETE ALL-IN-ONE Solution is indicated for use in chemical (NOT HEAT) disinfection, daily cleaning, rinsing, storing and lubricating/wetting of soft contact lenses. It should be used daily if lenses are worn on a daily basis. It should be used whenever lenses are removed (at least weekly) if lenses are worn on an extended wear basis.
COMPLETE ALL-IN-ONE Solution is also used to remove protein automatically.

CONTRA-INDICATIONS
Allergy to any ingredient in COMPLETE ALL-IN-ONE Solution.
COMPLETE ALL-IN-ONE Solution is not intended for direct instillation into the eye, nor for ingestion.

WARNINGS
Problems with soft contact lenses and lens care products could result in serious injury to the eye. Patients should be cautioned that proper use and care of contact lenses and lens care products, including lens cases, are essential for the safe use of these products.
Daily wear lenses are not indicated for overnight wear and should not be worn while sleeping. Clinical studies have shown that the risk for serious adverse reactions is significantly increased when lenses are worn overnight.
Clinical studies have shown that the incidence of microbial keratitis is significantly greater in extended wear contact lens users.The risk of microbial keratitis with extended wear lenses was directly related to the number of consecutive days that lenses were worn overnight without removal.
Studies have also shown that the incidence of microbial keratitis is higher in contact lens users who smoke.
Eye problems including corneal ulcers can develop rapidly and lead to loss of vision. If eye discomfort, excessive tearing, vision changes, redness of the eye or other eye problems are experienced lenses should be removed immediately and the eye care practitioner promptly contacted. It is recommended that contact lens wearers see their eye care practitioner twice each year or as directed.

INTERACTIONS
None known.

PREGNANCY AND LACTATION
There are no documented data in humans on the use of COMPLETE ALL-IN-ONE Solution during pregnancy and lactation.

DOSAGE AND DIRECTIONS FOR USE
Please read carefully and follow instructions.
General
COMPLETE ALL-IN-ONE Solution may be used with all soft contact lenses including disposables.
Lenses must be cleaned and disinfected whenever they are removed. Daily, if the lenses are worn on a daily basis or at least weekly if they are worn on an extended wear basis.
Always clean and rinse one lens at a time. Always work with the same lens first to avoid mix ups.
Before handling the lenses, wash and rinse the hands thoroughly. Use a neutral, non-medicated soap to wash the hands and use a clean, dry, lint-free towel to dry them.
Cleaning
Place a few drops of COMPLETE ALL-IN-ONE Solution on each lens surface and rub each side gently from the center to the edge for 10 seconds. Never rub in a circular motion, it may tear the lens and not clean the outer edge surface.
Rinsing
Rinse each side of the lens for at least 5 seconds with COMPLETE ALL-IN-ONE Solution to remove all traces of debris.
Disinfecting
Place lenses in the correct chambers of the lens case. Fill both chambers with fresh COMPLETE ALL-IN-ONE Solution. Replace caps. Allow lenses to soak for a minimum of six (6) hours. Your lenses are now ready for wear. Rinse the lens case with COMPLETE ALL-IN-ONE Solution and leave to air dry.
Storage
Lenses may be left in the unopened lens case in COMPLETE ALL-IN-ONE Solution for up to a maximum of 30 days. After this time, cleaning and disinfection must be carried out again before wearing the lenses.
Intensive Cleaning
COMPLETE ALL-IN-ONE Solution has been formulated to lift protein from your lenses during cleaning and disinfection. This automatic removal will help to keep your lenses smooth for enhanced wearing comfort. Where the level of protein deposits is unusually high a more intensive protein removal may be necessary. Your eye care practitioner will advise if you require protein removal tablets.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
The following side effects have been reported (frequencies unknown):
Eye disorders
Eyes sting, burn or itch (irritation)
Comfort is less than when lens was first placed on eye
Feeling of something in the eye (foreign body, scratched area)
Excessive watering (tearing) of the eyes
Unusual eye secretions
Reduced sharpness of vision (poor visual acuity)
Blurred vision, rainbows or halos around objects
Sensitivity to light (photophobia)
Dry eyes

If any of the above should be noticed:
Remove lenses
If the discomfort or problem stops, look closely at the lens.
If the lens is in any way damaged, DO NOT put the lens back in the eye. Place the lens in the storage case and contact the eye care practitioner.
If the lens has dirt, an eyelash, or other foreign body on it, or the problem stops and the lens appears undamaged, thoroughly clean, rinse and disinfect the lenses, then reinsert them.
If the problem continues, immediately remove the lens and consult the eye care practitioner. DO NOT put the lens back in the eye.

When any of the above symptoms occur, a serious condition such as infection, abrasion, corneal ulcer, neovascularisation, uveitis or iritis may be present. Seek immediate professional identification of the problem and promote treatment to avoid serious eye damage.
Precautions
All instructions must be followed. Failure to do so may result in serious eye infection or injury.
Do not wear lenses longer than prescribed.
Discard any lenses that are damaged or dehydrated.
Avoid using aerosols when wearing contact lenses.
If eye irritation occurs discontinue lens wear and contact your eye care practitioner.
Do not use the solution if the tamper evident seal is missing or broken.
Never re-use the solution in the lens case, always use fresh solution.
Always rub the lens for at least 10 seconds.
Do not rinse and store the lenses or lens case with tap water.
Keep the bottle tightly closed when not in use.
Use before the expiration date marked on the bottle.
Do not ingest COMPLETE ALL-IN-ONE Solution.
Never touch the dropper tip of the bottle to any surface as this may contaminate the solution. Close the bottle tightly immediately after use.
To prevent infection, NEVER wet contact lenses with saliva or place lenses in the mouth.
Do not swim, shower or bath while wearing contact lenses.
Only use COMPLETE ALL-IN-ONE Solution with the lens case provided.
Always discard your old lens case and use the new one provided.

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

IDENTIFICATION
Clear colourless solution contained in opaque white bottles.

PRESENTATION
Multidose 60 mL, 240 mL and 360 mL plastic bottles, sterile until opened.

STORAGE INSTRUCTIONS
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.
Discard any remaining solution 90 days after first opening the bottle.

REGISTRATION NUMBER
28/34/0455

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Genop Healthcare (Pty) Ltd
30 New Road (entrance off Bavaria Road)
Randjespark Ext 11, Midrand, 1682
Johannesburg, Gauteng
SOUTH AFRICA

For Advanced Medical Optics (AMO) Inc. U.S.A.

DATE OF PUBLICATION OF THE PACKAGE INSERT
1 December 2005

Updated on this site: September 2009
Source: Pharmaceutical Industry

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