Kullanma Kılavuzu

KAPVORM
PMS ZWART
à 100 %
45415-5
DIRECTIONS FOR USE:
FOR INTRAOCULAR USE. VISCOAT® (OVD) AND CANNULA AND CANNULA LOCKING RING ARE FOR SINGLE USE ONLY.
The syringe assembly is designed only for the injection of the VISCOAT® (OVD) it contains. Use of the syringe assembly for
aspiration is not advised. Refrigerated VISCOAT® (OVD) should be allowed to attain room temperature prior to use (approximately
20-40 minutes depending on quantity).
NOTICE:
THIS VISCOAT® (OVD) DELIVERY SYSTEM IS NOT DESIGNED OR INTENDED TO BE ATTACHED TO REUSABLE (METALHUBBED) INSTRUMENTS OR TO DISPOSABLE INSTRUMENTS OTHER THAN THE ONE PROVIDED WITH THE PRODUCT.
FAILURE TO FOLLOW THESE ASSEMBLY INSTRUCTIONS MAY RESULT IN CANNULA DETACHMENT.
®
BASE OF SYRINGE
YELLOW PLUNGER ROD
SYRINGE TIP
Oftalmik Viskocerrahi Cihaz›
(sodyum kondroitin sülfat – sodyum hiyalüronat)
TIP CAP
YELLOW
END CAP
RUBBER PLUNGER
TANIMI VE ‹ÇER‹⁄‹
VISCOAT® Oftalmik Viskocerrahi Cihaz› (OVD), yüksek derecede saflaflt›r›lm›fl, non enflamatuvar, orta moleküler a¤›rl›kl›,
sodyum kondroitin sülfat ve sodyum hiyalüronat›n steril,
apirojen, viskoelastik bir solüsyonudur. VISCOAT® (OVD)
40,000 ± 20,000 cps düzeyinde bir viskoziteyle formüle
edilmifltir (kopma oran›: 2 sn-1, 25° C).
1. PEEL LID FROM BLISTER PACK UNDER ASEPTIC CONDITIONS.
2. REMOVE RUBBER CAP FROM SYRINGE TIP. (CAP IS ON TIGHTLY).
YELLOW CAP
STERILE IRRIGATING
SOLUTION FILLED HUB
25°C’de Bohlin CS Reometresi Kullan›larak VISCOAT ® Ak›şkanl›ğ›
COLORLESS
CARTRIDGE
3. INJECT STERILE IRRIGATING SOLUTION INTO THE CANNULA
HUB AND FILL IT TO THE TOP.
Viskozite (Pa.s.)
BSS® STERILE
IRRIGATING SOLUTION
CANNULA FILLING HUB
OF VISCOAT®
CANNULA
4. EXPRESS THE AIR FROM THE TIP OF THE SYRINGE BY
HOLDING THE SYRINGE BARREL WITH ONE HAND WHILE
GENTLY DEPRESSING THE PLUNGER ROD WITH THE OTHER.
BE CAREFUL NOT TO EXPRESS VISCOELASTIC ONTO THE
OUTSIDE OF THE SYRINGE TIP.
CANNULA (WITH COLORLESS PLASTIC CARTRIDGE STILL IN PLACE)
5. THREAD THE CANNULA ONTO THE SYRINGE SLEEVE IN A CONTINUOUS MOTION BY USING THE CARTRIDGE AS A WRENCH. TWIST
UNTIL THE CANNULA HUB HAS TRAVELLED THE FULL LENGTH OF THE THREADS AND IS FIRMLY SEATED. USE ONLY THE CANNULA
PROVIDED.
6. VISUALLY INSPECT THAT THE CANNULA THREADS HAVE TRAVELLED THE FULL LENGTH OF THE SYRINGE SLEEVE THREADS.
7. REMOVE PLASTIC CARTRIDGE FROM THE CANNULA IN A STRAIGHT MOTION, BEING SURE NOT TO TWIST OR UNSCREW THE CANNULA
WHILE REMOVING THE CARTRIDGE.
CANNULA
Kopma Oran› (sn-1 )
Beher 1 ml VISCOAT® (OVD) 40 mg sodyum kondroitin sülfat, 30 mg sodyum hiyalüronat ; 0.45 mg sodyum dihidrojen
fosfat, monohidrat ; 2.00 mg disodyum fosfat, anhidr ; 4.3 mg
sodyum klorür (enjeksiyonluk suyla birlikte, k.m.) ihtiva
etmektedir. Sodyum hidroksit ve/veya hidroklorik asit pH
ayarlay›c›lar olarak kullan›labilr. VISCOAT® (OVD)'›n ozmolalitesi 325 ± 40 mOsm/kg pH de¤eri 7.0 ile 7.5 aras›ndad›r.
Sodyum kondroitin sülfat ve sodyum hiyalüronat, her ikisi de
büyük, dallanma yapmayan ve orta ile yüksek aras› moleküler
a¤›rl›¤a sahip zincir yap›s› olarak bulundu¤undan, kimyasal
ve fiziksel bileflimleri yönünden epey benzer niteliktedir.
VISCOAT® (OVD)'›n haz›rlanmas›nda kullan›lan sodyum
kondroitin sülfat yaklafl›k 22,500 dalton düzeyinde ortalama
moleküler a¤›rl›¤a sahipken sodyum hiyalüronat 500,000 daltonun üzerinde bir moleküler a¤›rl›k sergilemektedir.
Bu iki bilefli¤in fleker k›s›mlar›, tekrarlayan disakkarit alt birimleridir. Bu iki bileflik, sodyum kondroitin sülfat›n (sodyum hiyalüronatta oldu¤u üzere) tekrarlayan disakkarit alt birimleri
bafl›na bir sülfat grubuna ve tekli, negatif bir yükten ziyade bir
çiftli yüke sahip olmas› yönünden farkl›l›k göstermektedir.
ÖNER‹LEN KULLANIM YER‹
VISCOAT® (OVD), katarakt ekstraksiyonu ve intraoküler lens
implantasyonu dahil ön segment cerrahi prosedürlerinde cerrahi bir yard›mc› olarak kullan›lmal›d›r. VISCOAT® (OVD) ön
segment cerrahisi s›ras›nda kamara derinli¤ini korur, cerrahi
ifllem s›ras›nda görüflü artt›r›r ve kornea endotelini ve di¤er
göz dokular›n› korur. Solüsyonun viskoelastikli¤i vitröz yüzeyin normal konumunu muhafaza eder ve cerrahi s›ras›nda
kamaran›n düzleflmesini engeller.
YELLOW CANNULA
LOCKING RING
KULLANILMAMASI GEREKEN DURUMLAR
fiu an itibariyle önerildi¤i flekilde kullan›lmas› kofluluyla
VISCOAT® (OVD) kullan›m›na ba¤l› bilinen bir kontrendikasyon mevcut de¤ildir.
8. HOLD THE SYRINGE UPRIGHT.
SLIP THE CANNULA LOCKING
RING OVER THE CANNULA
ALLOWING THE DISTAL TIP OF
THE CANNULA TO PASS
THROUGH THE SMALL HOLE IN
THE CANNULA LOCKING RING.
9. SECURE THE CANNULA BY
ROTATING THE CANNULA
LOCKING RING CLOCKWISE
UNTIL IT STOPS AGAINST
THE CANNULA HUB.
10. PURGE THE REMAINING AIR FROM THE SYSTEM BY HOLDING THE SYRINGE BARREL WITH ONE HAND AND GENTLY DEPRESSING THE
PLUNGER ROD WITH THE OTHER UNTIL VISCOAT® (OVD) APPEARS AT THE CANNULA TIP.
STORE UPRIGHT
Distributed by:
Alcon Laboratuvarlar› Ticaret A.fi.
Kavac›k Ticaret Merkezi
Rüzgarl›bahçe Mah. Kavak Sok.
No:18 B-Blok Kat 1
34805 Beykoz / ‹stanbul, Turkey
Manufacturer:
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas,
USA 76134-2099
Produced by:
SA ALCON-COUVREUR NV
Rijksweg 14
B-2870 Puurs
Belgium
Authorized EU Representative:
Alcon Laboratories (UK) Ltd.,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,
United Kingdom
"Kullan›m Talimatlar›") dikkatli bir flekilde verilmelidir.
VISCOAT® (OVD) kamaraya, kristalin lens ç›kar›lmadan önce
ya da sonra enjekte edilebilir. VISCOAT® (OVD)'›n lens
ç›kar›lmadan önce enjekte edilmesi kornea endoteli için ek
koruma sa¤layacakt›r. Malzemenin bu aflamada enjeksiyonu
önemlidir, çünkü VISCOAT® (OVD) kaplamas›n›n kornea
endotelini, katarakt ekstraksiyonu cerrahisi s›ras›nda cerrahi
enstrumentasyona ba¤l› olas› zarara karfl› koruma sa¤layabilir. VISCOAT® (OVD) ayn› zamanda implantasyon cerrahisinden önce göz içi lensin yan› s›ra cerrahi aletlerinin
uçlar›n›n kaplanmas›nda da kullan›labilir. Ön segment cerrahisi s›ras›nda kamaray› tam olarak korumak ya da cerrahi
prosedür s›ras›nda yitirilen s›v›y› telafi etmek için ek
VISCOAT® (OVD) enjekte edilebilir. Ameliyat›n sonunda
VISCOAT® (OVD)'›n pratik aç›dan mümkün oldu¤u ölçüde
(steril bir y›kama solüsyonu kullan›larak) irigasyon ve aspirasyon yoluyla uzaklaflt›r›lmas› tavsiye edilmektedir.
SUNUM fiEKL‹
VISCOAT® (OVD) 0.35 ml, 0.50 ml ya da 0.75 ml kapasiteye
sahip tek kullan›ml›k fl›r›ngalarda sunulan ve steril, 27-gauge,
tek kullan›ml›k, küt, k›vr›k uçlu bir kanül ve kanül kilitleme
halkas›yla birlikte paketlenmifl, steril
apirojen, tek
kullan›ml›k
bir oftalmik Viskocerrahi Cihaz›d›r. VISCOAT®
(OVD) fl›r›ngalar› aseptik olarak doldurulmufl ve blister ambalajlarda paketlenmifltir. fi›r›ngalar›n d›fl k›s›mlar› etilen oksit
yöntemiyle sterilize edilmifltir.
BUZDOLABINDA 2°- 8°C ARASINDA MUHAFAZA ED‹N‹Z.
DONDURMAYINIZ VE IfiIK ALMAYACAK fiEKLDE MUHAFAZA ED‹N‹Z.
REFERANSLAR
1. CILCO, Inc. Study "Preclinical evaluation of CDS-PLUS :
Measurement of intraocular pressure variation after instillation into artificial eyes" (1983).
2. CILCO, Inc. Study "Preclinical evaluation of the protective
efficacy of CDS-PLUS on rabbit corneal buttons" (1983).
3. CILCO, Inc. Study "Evaluation of CDS for induction of anaphylaxis in guinea pigs" (1981).
4. Richter, W., Ryde, M. and Zetterstrom, O. Nonimmunogenicity of purified sodium hyaluronate preparation in man,
Int Arch Allergy Appl Immunol 59 :45-48,1979.
5. Richter, W. Nonimmunogenicity of purified hyaluronic acid
preparations tested by passive cutaneous anaphylaxis. Int
Arch Allergy Appl Immunol 47 :211-217, 1974.
6. CILCO, Inc. Study "Evaluation of CDS for induction of antibodies in rabbits" (1982).
7. Balazs, E.A. Ultrapure hyaluronic acid and the use thereof,
U.S. patent 4,141,973 (1979).
8. CILCO, Inc. Summary of Safety and Efficacy for VISCOAT®
(1984).
© 2005, 2010, 2012 Novartis
ET‹KETLEMEDE KULLANILAN SEMBOLLER
Sembol
UYARILAR
Kullanma talimat›nda yer alan tüm birlefltirme talimatlar›n›n yanl›fl takip edilmesi veya ek bir kanül kullan›m›
kanül ayr›lmas› ve ciddi yaralanma olas›l›¤› ile sonuçlanabilir.
Tekrar kullanmay›n›z
ÖNLEMLER
Al›nmas› gereken önlemler, gerçeklefltirilecek göz cerrahisi
prosedürüyle normalde ba¤lant›l› olanlarla s›n›rl›d›r. Sodyum
hiyalüronat ve sodyum kondroitin sülfat yüksek derecede
saflaflt›r›lm›fl biyolojik polimerler olmalar›na ra¤men hekim
her türlü biyolojik malzemenin kullan›lmas›ndan kaynaklanabilecek potansiyel alerji risklerini göz ard› etmemelidir.
Yukar›daki hususlar›n yan›s›ra afla¤›da belirtilen önlemlerin
de al›nmas› gerekmektedir :
• Kanülü tekrar kullanmay›n›z.
• Sadece malzeme berraksa kullan›n›z.
• Hava kabarc›klar› kalmamas›na dikkat ediniz.
• Sadece ambalaj zarar görmemiflse kullan›n›z.
Parti kodu
Son kullan›m tarihi
ÜRÜN Aseptik şlem Teknikleri
Kullan›larak Sterilize Edilmiştir.
PRMER KABI Etilen Oksit
Yöntemiyle Sterilize Edilmiştir.
S›cakl›k k›s›tlamas›
2°C-8°C aras›nda saklay›n›z.
Kuru doğal kauçuk ya da doğal
kauçuk lateks içermez.
ADVERS ETK‹LER
VISCOAT® (OVD) insan ve hayvan çal›flmalar›nda oldukça
iyi tolere edilmifltir. Göz içi bas›nçta art›fla neden olabildi¤i
gösterilmifl olan sodyum hiyalüronat›n varl›¤›na ba¤l› geçici
bir göz-içi bas›nc› art›fl› görülebilir (insan klinik çal›flmalar›nda
cerrahiden 1-3 gün sonra % 9.8 > 25 mmHg).
ÇEVKO Yeflil Nokta
(CEVKO Green Dot)
Geri Kazan›labilir Karton
(Recycable Carton)
21
PAP
Üretici
KL‹N‹K UYGULAMALARI
Katarakt ameliyat› ve intraoküler lens implantasyonu için,
VISCOAT® (OVD) ön kamaraya standart aseptik teknikler
kullan›larak (ve sadece birlikte verilen kanül kullan›larak, bkz.
Steril bariyer hasar görmüflse
kullanmay›n›z
Local
Ready for sending:
Graphics
280 x 335 / 140 x 44 mm
VISCOAT 0,35 ml - 0,5 ml - 0,75 ml
IDS CE GSF ID Viscoat REV05APRIL/2011
recto-verso
TR
AANTAL KLEUREN : 1
RVDV
04-12-2012
Approval
BELGIUM 45415-5
BESOP-00326
V7
Aç›klamasi
Dikkat: Kullan›m talimatlar›na
bak›n›z.
Affiliates
as is.
new proof.
The undersigned:
confirms that this proof contains an accurate translation of the English Corporate
Standard text, and is in compliance with the registered information and the legal
rules. Please also carefully check: local barcodes if any, formula, components if
mentionned, shelflife if mentionned, storage conditions and trademarks.
This proof is approved
Signature and date:
as is.
as is, waiting for M.O.H. approval.
(do not order component yet)
Customer requests
new proof.
Local
Final release:
Graphics
as is.
new proof.
KAPVORM
PMS ZWART
à 100 %
KULLANIM TAL‹MATLARI:
GÖZ ‹Ç‹ KULLANIMINA YÖNEL‹KT‹R. VISCOAT ® (OVD) VE KANÜL VE KANÜL K‹L‹TLEME HALKASI SADECE
TEK KULLANIMLIKTIR.
fi›r›nga düzene¤i sadece VISCOAT ® (OVD)’n›n enjekte edilmesi için tasarlanm›flt›r. fi›r›nga düzene¤inin aspirasyon için kullan›lmas› tavsiye edilmemektedir. Buzdolab›nda saklanm›fl VISCOAT ® (OVD) kullan›lmadan önce oda
s›cakl›¤›na gelmesi beklenmelidir (miktara ba¤l› olarak yaklafl›k 20-40 dakika).
UYARI: VISCOAT® (OVD) ÜRÜNLE B‹RL‹KTE VER‹LM‹fi OLANDAN BAfiKA YEN‹DEN KULLANILAB‹L‹R
(METAL GÖVDEL‹) ALETLERE YA DA TEK KULLANIMLIK ALETLERE TAKILMAK ÜZERE TASARLANMAMIfiTIR VEYA BU AMAÇLANMAMIfiTIR. BU MONTAJ TAL‹MATLARINA UYULMAMASI
KANÜLÜN ÇIKMASINA NEDEN OLAB‹L‹R.
fiIRINGA TABANI
SARI P‹STON M‹L‹
fiIRINGA UCU
UÇ KAPA⁄I
®
Ophthalmic Viscosurgical Device
(sodium chondroitin sulfate – sodium hyaluronate)
DESCRIPTION:
VISCOAT® Ophthalmic Viscosurgical Device (OVD) is a sterile,
non-pyrogenic, viscoelastic solution of highly purified, noninflammatory medium molecular weight sodium chondroitin
sulfate and sodium hyaluronate. VISCOAT® (OVD) is formulated to a viscosity of 40,000 ± 20,000 cps (at shear rate of
2 sec-1, 25°C).
VISCOAT® Rheology Using Bohlin CS Rheometer at 25°C
SARI UÇ
KAPA⁄
KAUÇUK P‹STON
SARI KAPAK
Viscosity (Pa.s.)
1. BL‹STER AMBALAJIN KAPA⁄INI ASEPT‹K KOfiULLAR ALTINDA AÇINIZ.
2. fiIRINGA UCUNDAN KAUÇUK KAPA⁄I ÇIKARTINIZ. (KAPAK SIKICA KAPALIDIR).
STER‹L ‹RR‹GASYON
SOLÜSYONU DOLUM
KAPA⁄I
VISCOAT ®
KANÜLÜNÜN
BSS® STER‹L
‹RR‹GASYON
SOLÜSYONU KANÜL
DOLUM KAPA⁄I
RENKS‹Z
KARTUfi
3. KANÜL KAPA⁄INA STER‹L YIKAMA SOLÜSYONU
ENJEKTE ED‹N VE A⁄ZINA KADAR DOLDURUN.
Shear Rate (sec-1)
4. fiIRINGA GÖVDES‹N‹ B‹R EL‹N‹ZLE TUTARKEN
D‹⁄ER EL‹N‹ZLE DALMA P‹STONUNU YUMUfiAKÇA
BASTIRARAK fiIRINGANIN UCUNDAK‹ HAVAYI
BOfiALTINIZ. fiIRINGA UCUNUN DIfi KISMINA
V‹SKOELAST‹K TAfiIRMAMAYA D‹KKAT ED‹N‹Z.
KANÜL (RENKS‹Z PLAST‹K KARTUfi HALA TAKILIYKEN)
5. KARTUfiU B‹R SOMUN ANAHTARI G‹B‹ KULLANARAK SÜREKL‹ B‹R HAREKETLE KANÜLÜ fiIRINGA KOLUNA
V‹DALAYIN. KANÜL KAPA⁄INI V‹DALARIN SONUNA GELENE VE SIKICA OTURANA KADAR DÖNDÜRÜN. SADECE
B‹RL‹KTE VER‹LEN KANÜLÜ KULLANIN.
6. KANÜLÜN D‹fiLER‹N‹N, fiIRINGA KOLU V‹DA D‹fi‹NE TAMAMEN OTURDU⁄UNDAN EM‹N OLUN.
7. PLAST‹K KARTUfiU KANÜLDEN DÜZ B‹R HAREKETLE ÇIKARTIN VE KARTUfiU ÇIKARTIRKEN KANÜLÜ
DÖNDÜRMEMEYE YA DA SÖKMEMEYE ÖZEN GÖSTER‹N.
KANÜL
SARI KANÜL
K‹L‹TLEME HALKASI
Each 1 ml of VISCOAT® (OVD) contains 40 mg sodium chondroitin sulfate; 30 mg sodium hyaluronate; 0.45 mg sodium
dihydrogen phosphate, monohydrate; 2.0 mg disodium phosphate, anhydrous; 4.3 mg sodium chloride (with water for
injection. q.s.). Sodium hydroxide and/or hydrochloric acid
may be used as pH adjusters. The osmolality of VISCOAT®
(OVD) is 325 ± 40 mOsm/kg; the pH is 7.0 to 7.5.
Sodium chondroitin sulfate and sodium hyaluronate are quite
similar in regard to chemical and physical composition, as
each occurs as a large, unbranched chain structure of
medium to high molecular weight. The sodium chondroitin
sulfate used in the preparation of VISCOAT® (OVD) has a
mean molecular weight of approximately 22,500 Daltons,
while the sodium hyaluronate exhibits a molecular weight of
over 500,000 Daltons.
The sugar moieties of these two compounds occur as repeating disaccharide subunits. The two compounds differ in
that sodium chondroitin sulfate possesses a sulfate group
and a double, rather than a single, negative charge (as in
the case of sodium hyaluronate) per repeating disaccharide
subunit.
INDICATIONS:
VISCOAT® (OVD) is indicated for use as a surgical aid in anterior segment procedures including cataract extraction and
intraocular lens implantation. VISCOAT® (OVD) maintains a
deep chamber during anterior segment surgery, enhances
visualization during the surgical procedure, and protects the
corneal endothelium and other ocular tissues. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during
surgery.
CONTRAINDICATIONS:
At the present time, there are no known contraindications
to the use of VISCOAT® (OVD) when used as recommended.
8. fiIRINGAYI D‹K TUTUN.
KANÜL K‹L‹TLEME
HALKASINI KANÜLÜN
ÜZER‹NE KAYDIRARAK
KANÜLÜN UZAK UCUNUN
KANÜL K‹L‹TLEME
HALKASINDAK‹ KÜÇÜK
DEL‹KTEN GEÇMES‹N‹
SA⁄LAYIN.
9. KANÜL K‹L‹TLEME
HALKASINI SAAT
‹ST‹KAMET‹NDE KANÜL
KAPA⁄INA YASLANANA
DEK DÖNDÜREREK
KANÜLÜ SAB‹TLEY‹N.
10. fiIRINGANIN GÖVDES‹N‹ B‹R EL‹N‹ZLE TUTARKEN D‹⁄ER EL‹N‹ZLE P‹STON M‹L‹NE, KANÜL UCUNDA VISCOAT®
(OVD) GÖRÜNENE DEK YUMUfiAKÇA BASTIRARAK S‹STEMDE KALAN HAVAYI BOfiALTIN.
D‹K POZ‹SYONDA MUHAFAZA ED‹N‹Z.
Da¤›t›c›:
Alcon Laboratuvarlar› Ticaret A.fi.
Kavac›k Ticaret Merkezi
Rüzgarl›bahçe Mah. Kavak Sok.
No:18 B-Blok Kat 1
34805 Beykoz / ‹stanbul, Türkiye
Üretici:
Alcon Laboratories, Inc.
6201 South Freeway
Forth Worth, Texas,
USA 76134-2099
Üretim yeri:
SA Alcon-Couvreur NV
Rijksweg 14
B-2870 Puurs,
Belgium
Yetkili AB Temsilcisi:
Alcon Laboratories (UK) Ltd.,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,
United Kingdom
aseptic techniques (and using only the cannula provided,
see “Directions for Use” below) into the anterior chamber.
VISCOAT® (OVD) may be injected into the chamber prior to or
following removal of the crystalline lens. Instillation of
VISCOAT® (OVD) prior to lens removal will provide additional
protection to the corneal endothelium. Instillation of the solution at this point is significant in that a coating of VISCOAT®
(OVD) may protect the corneal endothelium from possible
damage arising from surgical instrumentation during the
cataract extraction surgery. VISCOAT® (OVD) may also be
used to coat an intraocular lens as well as the tips of surgical instruments prior to implantation. Additional VISCOAT®
(OVD) may be injected during anterior segment surgery to
fully maintain the chamber or replace any volume lost during
the surgical procedure. At the end of the surgical procedure
it is recommended that VISCOAT® (OVD) be removed from
the eye as completely as practical by thorough irrigating
(with sterile irrigating solution) and aspiration.
HOW SUPPLIED:
, non-pyrogenic, singleVlSCOAT® (OVD) sterile
use
ophthalmic viscosurgical device is supplied in a
disposable syringe delivering 0.35 ml, 0.50 ml or 0.75 ml,
packaged with a sterile 27-gauge, disposable, bent, blunt-tip
cannula and cannula locking ring. VISCOAT® (OVD) syringes
are aseptically filled and packaged in blister packs. Syringe
exteriors are sterilized by ethylene oxide.
STORE IN REFRIGERATOR BETWEEN 2°–8°C.
PROTECT FROM FREEZING AND LIGHT.
REFERENCES
1. CILCO, Inc. Study “Preclinical evaluation of CDS-PLUS:
Measurement of intraocular pressure variation after instillation
into artificial eyes” (1983).
2. CILCO, Inc. Study “Preclinical evaluation of the protective
efficacy of CDS-PLUS on rabbit corneal buttons” (1983).
3. CILCO, Inc. Study “Evaluation of CDS for induction of anaphylaxis in guinea pigs” (1981).
4. Richter, W., Ryde, M. and Zetterstrom, O. Nonimmunogenicity
of purified sodium hyaluronate preparation in man, Int Arch
Allergy Appl Immunol 59:45-48, 1979.
5. Richter, W. Nonimmunogenicity of purified hyaluronic acid
preparations tested by passive cutaneous anaphylaxis. Int
Arch Allergy Appl Immunol 47:211-217, 1974.
6. CILCO, Inc. Study “Evaluation of CDS for induction of antibodies in rabbits” (1982).
7. Balazs, E.A. Ultrapure hyaluronic acid and the use thereof,
U.S. patent 4,141,973 (1979).
8. CILCO, Inc. Summary of Safety and Efficacy for VISCOAT®
(1984).
© 2005, 2010, 2012 Novartis
SYMBOLS USED ON LABELING
Symbol
English
WARNINGS:
Failure to follow all of the assembly instructions in
"Directions for Use" or use of an alternate cannula may
result in cannula detachment and the possibility of
serious injury.
Attention:
See Instructions for Use
PRECAUTIONS:
Precautions are limited to those normally associated with
the surgical procedure being performed. Although sodium
hyaluronate and sodium chondroitin sulfate are highly purified
biological polymers, the physician should be aware of the
potential allergic risks inherent in the use of any biological
material.
In addition to the above, the following precautions should
be observed:
• Do not reuse cannula.
• Use only if material is clear.
• Avoid trapping air bubbles.
• Use only if the container is undamaged.
Use by (YYYY-MM): Year-Month
ADVERSE REACTIONS:
VISCOAT® (OVD) has been extremely well tolerated in
human and animal studies. A transient rise in intraocular
pressure may be expected due to the presence of sodium
hyaluronate, which has been shown to effect such a rise
(9.8% > 25 mmHg during 1–3 days after surgery in human
clinical trials).
Do not reuse
Batch Code
PRODUCT Sterilized Using
Aseptic Processing Techniques
PRIMARY CONTAINER
Sterilized by Ethylene Oxide
Temperature limitation.
Store between 2°- 8°C.
Does not contain dry natural
rubber or natural rubber latex
ÇEVKO Green Dot
Recyclable incorrugated
cardboard
21
PAP
Manufacturer
CLINICAL APPLICATIONS:
For cataract surgery and intraocular lens implantation,
VISCOAT® (OVD) should be carefully injected using standard
Do not use if sterile barrier is
breached
12-2012
45415-5
Local
Ready for sending:
Graphics
280 x 335 / 140 x 44 mm
VISCOAT 0,35 ml - 0,5 ml - 0,75 ml
IDS CE GSF ID Viscoat REV05APRIL/2011
recto-verso
TR
AANTAL KLEUREN : 1
RVDV
04-12-2012
Approval
BELGIUM 45415-5
BESOP-00326
V7
Affiliates
as is.
new proof.
The undersigned:
confirms that this proof contains an accurate translation of the English Corporate
Standard text, and is in compliance with the registered information and the legal
rules. Please also carefully check: local barcodes if any, formula, components if
mentionned, shelflife if mentionned, storage conditions and trademarks.
This proof is approved
Signature and date:
as is.
as is, waiting for M.O.H. approval.
(do not order component yet)
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Graphics
as is.
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