Medical device OPKOHealth OCULAR DROPSVIS ACTIV NEO muhl dose 10 mi. Sterile Page: 30 of 34

Transcription

1 Medical device OPKOHealth OCULAR DROPSVIS ACTIV NEO muhl dose 10 mi. Sterile Page: 30 of 34 Document No.: I Date Effective: 4/05/2015 Revision No.: voo Requirements for certificate of product registration of medical devices 12. Labeling materials for all sizes/reference codes to be used for the/ product: Immediate label, secondary packaging, box label and package insert /brochure, whichever is applicable. All the labeling materials can be found in Annex 1; An example for the information leaflet. put inside the box of the finally packaging. is included in Annex l/f. An example for the secondary packaging. comprehensive with the information here reported. is included in Annex l/a. Annex lie is an example for the bottle label

2 OPKOHealth Vis Active Neo Annex 1 ANNEX 1fF: LEAFLET

3 NEO No preservatives 3 months of use Sterile solution 10 ml Natural relief for dry eyes Lubrication Strong and lasting moisturisation Protective filmogenic action Preservative-free solution which, thanks to its high technology filter, remains sterile throughout its continued use. As it contains no preservatives, it is gentle on the surface of the eye and can be used as often as required. VISactiV@ NEO is a sterile hypo-osmolar ophthalmic solution, with the natural ph of tears, containing high molecular-weight Hyaluronic Acid and distilled water of Aloe vera and Centella asiatica. The combined action of these substances relieves: - Dry eyes as a result of: o Hormonal changes: menopause, menstruation and use of oral contraceptives o Aging o External agents: wearing contact lenses, exposure to very dry environments, etc. o Side effects of certain medicines o Certain disorders: Sjogren's syndrome, rheumatoid arthritis, lupus, etc. - Small lesions caused by: o Foreign bodies: sand, dust o Contact lenses - The eye symptoms caused by contact with allergens INSTRUCTIONS FOR USE: Open the bottle and squeeze gently to apply 1 drop to each eye. Replace cap after each use. Since it contains no preservatives, it can be used as often as required. Suitable for wearers of contact lenses. Can be used up to 3 months after opening. For single-person use. 305

4 COMPOSITION: Distilled Aloe vera water (10%), distilled Centella asiatica water (10%), high molecular-weight hyaluronic acid (sodium salt) (0.15%), sodium phosphate dibasic dihydrate, sodium phosphate monobasic monohydrate, sodium chloride, water for injection q.s. 100 ml. Warning: Read the instructions inside carefully before using. Keep out of the reach of children. BAR CODE: CE 0373 MEDICAL DEVICE STERILE A "Tidy-man" symbol and "Green dot" symbol Ltd..llnnODeVice Northwest Wing, Bush House, Aldwych, London WC2B 4EZ IMPORTED & DISTRIBUTED BY: Rx Global Sales and Mktg. Corp Jollibee Plaza, Emerald Avenue, Ortigas Center, Pasig City 1605, Philippines.

5 OPKOHealth Vis Active Neo Annex 1 ANNEX lie: LABEL

6 LABEL VISACTIV NEO VIS ACTIV NEO Eye drops Preservative Free 2 months of use Natural relief for dry eyes, lubrication, strong and lasting moisturisation, protective filmogenic action CE 0373 Sterile A (pictogram) Legal manufacturer (pictogram) InnoDevice Ltd. Northwest Wing, Bush House, Aldwych, London WC2B 4EZ Booklet (pictogram) 10 ml Sterile Solution Lot symbol Expiry date symbol. 30t

7 OPKOHealth Vis Active Neo Annex 1 ANNEX1/ A BOX

8 VISactiV NEO No preservatives 3 months of use Sterile solution 10 ml Natural relief for dry eyes Lubrication Strong and lasting moisturisation Protective filmogenic action Preservative-free solution which, thanks to its high technology filter, remains sterile throughout its continued use. As it contains no preservatives, it is gentle on the surface of the eye and can be used as often as required. VISactiV NEO is a sterile hypo-osmolar ophthalmic solution, with the natural ph of tears, containing high molecular-weight Hyaluronic Acid and distilled water of Aloe vera and Centella asiatica. The combined action of these substances relieves: - Dry eyes as a result of: o Hormonal changes: menopause, menstruation and use of oral contraceptives o Aging o External agents: wearing contact lenses, exposure to very dry environments, etc. o Side effects of certain medicines o Certain disorders: Sjogren's syndrome, rheumatoid arthritis, lupus, etc. - Small lesions caused by: o Foreign bodies: sand, dust o Contact lenses - The eye symptoms caused by contact with allergens INSTRUCTIONS FOR USE: Open the bottle and squeeze gently to apply 1 drop to each eye. Replace cap after each use. Since it contains no preservatives, it can be used as often as required. Suitable for wearers of contact lenses. Can be used up to 3 months after opening. For single-person use.

9 COMPOSITION: Distilled Aloe vera water (10%), distilled Centella asiatica water (10%), high molecular-weight hyaluronic acid (sodium salt) (0.15%), sodium phosphate dibasic dihydrate, sodium phosphate monobasic monohydrate, sodium chloride, water for injection q.s. 100 ml. Warning: Read the instructions inside carefully before using. Keep out of the reach of children. BAR CODE: CE 0373 MEDICAL DEVICE STERILE A "Tidy-man" symbol and "Green dot" symbol.i,nnodevice Ltd. Northwest Wing, Bush House, Aldwych, London WC2B 4EZ IMPORTED & DISTRIBUTED BY: Rx Global Sales and Mktg. Corp Jollibee Plaza, Emerald Avenue, Ortigas Center, Pasig City 1605, Philippines. 3JD.

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11 IUJ OL UO'l":?S IU'15 UOIIll'_IYOAOJOloJd '1IOjIP<jJ11l!!OW6l\lSI1purliuQJlS 'lid!l ' (E: 0373 activ Neo rhl ':..71 ~~ activ Neo S41~lOOJ.1OO,1nnoDftk.1.bI. =wa~hhoust, AJdwydI. Inwted & dislllbu1ed ~::!'~'I!a~~~ ~i~.ptltiippi""

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16 ~activ ~NeO NATURAL RELIEF FOR DRY EYES, LUBRICATION, STRONG AND LASTING MOISTURISATION, PROTECTIVE FILMOGENIC ACTION No preservatives Sterile solution Preservative-free solution which, thanks to its high technology filter, remains sterile throughout its continued use. As it contains no preservatives, it is gentle on the surface of the eye and can be used frequently and with contact lenses. VISact;v Neo is a sterile hypo-osmolar ophthalmic solution, with the natural ph of tears, containing high molecular-weight Hyaluronic Acid (0.15%) and distilled water of Aloe vera (10%) and Centella as;atka (10%). The combined action of these substances relieves: - dry eyes as a result of: hormonal changes: menopause, menstruation and use of oral contraceptives aging exposure to dry, centrally-heated environments external agents: wearing contact lenses. exposure to very dry environments, ete. side effects of certain medicines certain disorders: SjOgren's syndrome, rheumatoid arthritis, lupus, ete. - sm lllesions caused by: foreign bodies: sand, dust contact lenses - the eye symptoms caused by contact with allergens. INSTRUCTIONS FOR USE Open the bottle and squeeze gently to apply 1 drop to each eye. Replace cap after each use. Since it contains no preservatives, It can be used frequently throughout the day. Compatible with contact lenses. Can be used up to 3 months after opening. Container for personal use. COMPOSITION Water for injection q.s. 100 ml, distilled Aloe vera water (10%), distilled Centella asiatica water (10%), high molecular-weight Hyaluronic Acid (sodium salt) (0.15%), sodium phosphate dibasic dihydrate, sodium phosphate monobasic monohydrate and sodium chloride. o PRECAUTIONS AND WARNINGS Product for ophthalmic use only. Do not use if the container is damaged or not properly sealed when first opening. Avoid contact with the eye or any other surface with the applicator when applying the product. Do not use the product if you are sensitive to any of its components. Store at room temperature. Do not use after the expiry date Indicated on the package. Do not dispose ot the container Into the environment after use. Keep the product out of the reach of small children. -If you feel discomfort during use, discontinue the treatment and consult a doctor. Avoid using the product at the same time as detergent or disinfectant solutions containing benzalkonium chloride or other quaternary ammonium salts, as they may cause the hyaluronic acid to form a precipitate. PRESENTATION Multidose container with 10 ml of sterile solution. SHELF LIFE Unopened, do not use after the expiry date stated on the box and the bottle label. The contents can be used up to 3 months after opening. MANUFACTURER: InnoDevfce Ltd. Northwest Wing, Bush House, Aldwych, London WOB 4EZ IMPORTED & DISTRIBUTED BY: Rx Global Sales and Mktg. Corp Jollibee Plaza, Emerald Avenue, Ortigas Center, Pasig City 1605, Philippines. Rev. no: ( 0373 MEDICAL ISTERILE DEVICE I A I 3ft

17 NATURAL ~activ" ~NeO RELIEF FOR DRY EYES, LUBRICATION, STRONG AND LASTING MOISTURISATION, PROTECTIVE FILMOGENIC ACTION No preservatives Sterile solution Preservative-free solution which, thanks to its high technology filter, remains sterile throughout its continued use. As it contains no preservatives, it is gentle on the surface of the eye and can be used frequently and with contact lenses. VISactiv Neo is a sterile hypo-osmolar ophthalmic solution, with the natural ph of tears, containing high molecular-weight Hyaluronic Acid (0.1 S%) and distilled water of Aloe vera (10%) and Centella asiatica (10%). The combined action of these substances relieves: - dry eyes as a result of: hormonal changes: menopause, menstruation and use of oral contraceptives aging exposure to dry, centrally-heated environments external agents: wearing contact lenses. exposure to very dry environments. ete. side effects of certain medicines certain disorders: SjOgren's syndrome, rheumatoid arthritis, lupus, etc. - small lesions caused by: foreign bodies: sand, dust contact lenses - the eye symptoms caused by contact with allergens. INSTRUCTIONS FOR USE Open the bottle and squeeze gently to apply 1 drop to each eye. Replace cap after each use. Since it contains no preservatives, it can be used frequently throughout the day. Compatible with contact lenses. Can be used up to 3 months after opening. Container for personal use. COMPOSITION Water for injection q.s. 100 ml, distilled Aloe vera water (10%), distilled Centella asiatica water (10%), high molecular-weight Hyaluronic Acid (sodium salt) (0.15%), sodium phosphate dibaslc dihydrate, sodium phosphate monobasic monohydrate and sodium chloride. PRECAUTIONS AND WARNINGS Product for ophthalrmc use only. Do not use if the container is damaged or not properly sealed when first opening. Avoid contact with the eye or any other surface with the applicator when applying the product. Do not use the product if you are sensitive to any of its components. Store at room temperature. Do not use after the expiry date indicated on the package. o Do not dispose of the container Into the environment after use. Keep the product out of the reach of small children. If you feel discomfort during use, discontinue the treatment and consult a doctor. Avoid using the product at the same time as detergent or disinfectant solutions containing benzalkonium chloride or other quaternary ammonium salts, as they may cause the hyaluronic acid to form a precipitate. PRESENTAnON Multidose container with 10 ml of sterile solution. SHELF LIFE Unopened, do not use after the exprry date stated on the box and the bottle label. The contents can be used up to 3 months after opening. MANUFACTURER: InnoDevlce ltd. Northwest Wing, Bush House, Aldwych, London WOB 4EZ IMPORTED & DISTRIBUTED BY: Rx Global Sales and Mktg. Corp Jollibee Plaza, Emerald Avenue, Ortigas Center, Pasig City 1605, Philippines. Rev. no;os/20 1S ( 0373 MEDICAL DEVICE ISTERILE I A I

18 NATURAL ~activ ~Neo RElIEF FOR DRY EYES, LUBRICATION, STRONG AND LASTING MOISTURISAnON, PROTECTIVE FILMOGENIC ACTION No preservatives Sterile solution Preservative-free solution whrch, thanks to its high technology filter, remains sterile throughout its continued use. As it contains no preservatives, it is gentle on the surface of the eye and can be used frequently and with contact lenses. VISactiv Neo is a sterile hypo-osmolar ophthalmic solution, with the natural ph of tears, containing high molecular-weight Hyaluronic Acid (0.1 S%) and distilled water of Aloe vera (10%) and Centella asiatica (10%). The combined action of these substances relieves: - dry eyes as a result of: hormonal changes: menopause. menstruation and use of oral contraceptives o aging o exposure to dry, centrally-heated environments external agents: wearing contact lenses. exposure to very dry environments, ete. side effects of certain medicines o certain disorders: Sjogren's syndrome, rheumatoid arthritis, lupus, etc. - small lesions caused by: o foreign bodies: sand, dust contact lenses - the eye symptoms caused by contact with allergens. INSTRUCTIONS FOR USE Open the bottle and squeeze gently to apply 1 drop to each eye. Replace cap after each use. Since it contains no preservatives, it can be used frequently throughout the day. Compatible with contact lenses. Can be used up to 3 months after opening. Container for personal use. COMPOSITION Water for injection q.s. 100 ml, distilled Aloe vera water (10%), distilled Centel/a asiatica water (10%), high molecular-weight Hyaluronic Acid (sodium salt) (0.1 S%), sodium phosphate dibasic dihydrate, sodium phosphate monobasic monohydrate and sodium chloride. PRECAUTIONS AND WARNINGS o Product for ophthalmic use only. o Do not use if the container is damaged or not properly sealed when first opening. o Avoid contact with the eye or any other surface with the applicator when applying the product. o Do not use the product If you are sensitive to any of its components. Store at room temperature. o Do not use after the expiry date Indicated on the package. e Do not dispose of the container Into the environment after use. o Keep the product out of the reach of small children. o If you feel discomfort during use, discontinue the treatment and consult a doctor. Avoid using the product at the same time as detergent or disinfectant solutions containing benzalkonium chloride or other quaternary ammonium salts, as they may cause the hyaluronic acid to form a precipitate. PRESENTATION Multidose container with 10 ml of sterile solution. SHELF LIFE Unopened, do not use after the expiry date stated on the box and the bottle label. The contents can be used up to 3 months after opening. MANUFACTURER: InnoDevlce ltd. Northwest Wing, Bush House, Aldwych, London WC2B 4EZ IMPORTED & DISTRIBUTED BY: Rx Global Sales and Mktg. Corp lollibee Plaza, Emerald Avenue, Ortigas Center, Pasig City 1605, Philippines. Rev. no:05/201 S ( 0373 MEDICAL ISTERILE DEVICE I A I