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Logo OXYSEPT 1 STEP DISINFECTING SOLUTION
OXYSEPT 1 STEP NEUTRALISING TABLETS

SCHEDULING STATUS:
Schedule 0

PROPRIETARY NAME
(and dosage form):

OXYSEPT 1 STEP DISINFECTING SOLUTION
OXYSEPT 1 STEP NEUTRALISING TABLETS

COMPOSITION
OXYSEPT 1 STEP DISINFECTING SOLUTION contains:
Hydrogen peroxide 31,0 mg/mL

OXYSEPT 1 STEP NEUTRALISING TABLETS contain:
5 200 i.u.
Catalase/tablet
Other ingredients: Sodium chloride, sodium phosphate, polyethylene glycol, hydroxypropyl methylcellulose (HPMC) and cyanocobalamine (Vitamin B
12) as indicator.

PHARMACOLOGICAL CLASSIFICATION
A.34 Other

PHARMACOLOGICAL ACTION
OXYSEPT 1 STEP DISINFECTING SOLUTION contains hydrogen peroxide which has antimicrobial properties.

OXYSEPT 1 STEP NEUTRALISING TABLETS contain catalase, which neutralises hydrogen peroxide in OXYSEPT 1 STEP DISINFECTING SOLUTION.

INDICATIONS
OXYSEPT 1 STEP DISINFECTING SOLUTION and OXYSEPT 1 STEP NEUTRALISING TABLETS is a complete lens care system for cleaning and disinfecting all soft contact lenses.
OXYSEPT 1 STEP NEUTRALISING TABLETS are indicated as a neutraliser for hydrogen peroxide 3% (e.g. OXYSEPT 1 STEP DISINFECTING SOLUTION) used for disinfecting soft contact lenses.

CONTRA-INDICATIONS
OXYSEPT 1 STEP DISINFECTING SOLUTION is not intended for direct use in the eye. OXYSEPT 1 STEP DISINFECTING SOLUTION and OXYSEPT 1 STEP NEUTRALISING TABLETS are contra-indicated in patients who are sensitive to any component of these products. Consult a doctor before using any eye medicament with contact lenses. If in any doubt about the suitability of the lenses for the use of this product, please consult an eye care specialist.

WARNINGS
Only use the OXYSEPT lens case with a grey blue left lens basket indicated in the directions for use.
Do not use tablets that are irregular in appearance.
Do not take tablets internally.
Always add an OXYSEPT 1 STEP NEUTRALISING TABLET to the OXYSEPT 1 STEP DISINFECTING SOLUTION to complete the disinfection and neutralisation process.

DOSAGE AND DIRECTIONS FOR USE
Being a delayed release formulation, the OXYSEPT 1 STEP NEUTRALISING TABLET is added to the OXYSEPT 1 STEP DISINFECTING SOLUTION at the start of the disinfection cycle.
Daily Lens Care Procedure
Carry out the following procedure every time lenses are removed.
Lens Preparation
1. Wash, rinse and dry hands before handling your lenses.
2. Remove cap containing lens baskets from the lens case and fill to the fill line with OXYSEPT 1 STEP DISINFECTING SOLUTION.
3. Remove one lens at a time.
4. If a surfactant cleaner is included in the regimen, follow the instructions for cleaning and rinsing as directed on the labelling.
5. Place the lenses in the appropriate baskets of the OXYSEPT lens case.
Disinfection/Neutralisation Procedure
1. Dispense one OXYSEPT 1 STEP NEUTRALISING TABLET into the OXYSEPT lens case containing the OXYSEPT 1 STEP DISINFECTING SOLUTION.
2. Immediately replace the lens holder in the lens case and tighten the cap.
3. Gently turn the lens case upside down, then right side up 3 consecutive times to wet the upper surfaces of the cup and the inside of the cap.
4. Make sure that the tablet is in the solution before allowing the lenses to disinfect.
5. Allow your lenses to soak overnight (or at least 6 hours.) The OXYSEPT 1 STEP NEUTRALISING TABLET contains an indicator that will cause the solution to turn pink when the tablet has dissolved. The pink colour indicates only that the tablet has been added. The lenses must soak for a minimum of 6 hours for neutralisation.
6. Before removing the lenses from the lens case, turn the lens case upside down for 5 seconds to ensure full neutralisation of all residual disinfecting solution in the lens case, then return case to upright position prior to opening.
7. Then apply the lenses to your eyes, or rinse the lenses with sterile saline solution (not OXYSEPT 1 STEP DISINFECTING SOLUTION) and apply them to your eyes.
8. Discard solution, rinse the entire lens case assembly with sterile rinsing solution. Do not use soap or detergent. Air dry.

NOTE
OXYSEPT 1 STEP DISINFECTING SOLUTION SHOULD NEVER COME IN DIRECT CONTACT WITH THE EYES. ALWAYS NEUTRALISE THE LENSES AS INDICATED ABOVE PRIOR TO PLACING ON THE EYES.

Cleaning the Lens Case
1. Once a week, while wearing your lenses, fill the empty OXYSEPT lens case to the fill line with OXYSEPT 1 STEP DISINFECTING SOLUTION (do not add an OXYSEPT 1 STEP NEUTRALISING TABLET.)
2. Tighten the cap.
3. Turn the lens case upside-down.
4. Leave the lens case in this position until you are ready to remove and disinfect your lenses.
5. You may use the solution remaining in the lens case to disinfect your lenses because the OXYSEPT 1 STEP NEUTRALISING TABLET has not yet been added.
  OR
6. On a daily basis, after adding the OXYSEPT 1 STEP NEUTRALISING TABLET to the OXYSEPT 1 STEP DISINFECTING SOLUTION, tighten the cap and gently invert the OXYSEPT lens case 3 times to wet the upper surfaces of the lens case and inside of the cap.
7. Make sure that the tablet is still in the solution before allowing the lenses to disinfect.

NOTE
Lenses may be stored in the unopened lens case after disinfection for a maximum of 7 days. If they are stored for longer than 7 days, disinfect and neutralise every 7 days and again before applying lenses to the eyes.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
No finality has been reached on the long-term safety of soft contact lens preparations.
Do not touch dropper tips of bottles to any surface. This may contaminate the solution. Keep bottle tightly closed when not in use.
Always use fresh solution. Use before the expiration date marked on the container. Discard after use.
Always handle the same lens first to avoid any mix-ups.
To prevent infection, NEVER wet contact lenses with saliva or place lenses in your mouth.
Never use OXYSEPT 1 STEP DISINFECTING SOLUTION or OXYSEPT 1 STEP NEUTRALISING TABLETS in a heat disinfection unit as these products are not designed for use with heat disinfection.
Do not mix with other fluids except as directed.
If irritation should develop, discontinue use and consult an eye care professional.
When using OXYSEPT 1 STEP NEUTRALISING TABLETS, to avoid contamination, do not handle the tablets or allow them to come in contact with any surface.
Always place the OXYSEPT 1 STEP NEUTRALISING TABLET in the OXYSEPT 1 STEP DISINFECTING SOLUTION at the same time as you place your lenses in the solution.
If you notice that the OXYSEPT 1 STEP NEUTRALISING TABLET has not dissolved and effervesced, then do not place lenses in the eyes directly from the OXYSEPT 1 STEP DISINFECTING SOLUTION.
Always ensure that the tablet has fully dissolved and that bubbling has stopped before putting your lenses into your eyes. If the tablet has not dissolved fully, repeat the disinfection and neutralisation stages.
If any tablet appears discoloured, crushed, broken or chipped, or the blister card appears damaged in any way, DO NOT USE any tablet from that card. Use a tablet from another card to neutralise the peroxide.
Do not use OXYSEPT 1 STEP NEUTRALISING TABLETS if the foil barrier has been damaged prior to the day of use.
Keep out of reach of children.
Keep bottle tightly closed.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF IT’S TREATMENT
Treatment is symptomatic if ingested accidentally.

IDENTIFICATION
OXYSEPT 1 STEP DISINFECTING SOLUTION: Clear, colourless solution practically free from particulate matter.
OXYSEPT 1 STEP NEUTRALISING TABLETS: Pink to pale greyish purple, slightly mottled, smooth, round, slightly convex tablets. Tablet is practically odourless.

PRESENTATION
OXYSEPT 1 STEP DISINFECTING SOLUTION is available in 120 mL and 300 mL plastic dropper bottles.
OXYSEPT 1 STEP NEUTRALISING TABLETS are available in blister cards containing 12 or 15 tablets in combinations of 12 or 30 tablets per package.

STORAGE INSTRUCTIONS
Store below 25°C. Protect from light. Keep in a dry place.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
OXYSEPT 1 STEP DISINFECTING SOLUTION - S/34/227
OXYSEPT 1 STEP NEUTRALISING TABLETS - Z/34/208

NAME AND BUSINESS ADDRESS OF THE APPLICANT
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 THIS PACKAGE INSERT
13 February 1992

Updated on this site: September 2009
Source: Pharmaceutical Industry

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