Gima CATHETER LUBRICANT GEL 12 ml User guide

KONIX LIDO e STERiL KATETER JEL KULLANIM KILAVUZU /

Paket hasarl1 isekullanma niz

Donotuseifpackageisdamaged

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Kullanim k1lavuzuna bakm1z.

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Consult instructions for use

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"LOT'numaras1

Code

Batch

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Uniquedevice identification

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Caution

KatalogNumaras1
Catalogue Number

ISJERLEIRI

RadyasyonSterilizasyonu.

lrradiatianSterilizatian.

Code 150.06.05.0575

21.10.20211 Rev.: 10

Kuruartamdasaklaym1z
KeepDry.

Tekkullan1111l1kt1r.
Dono! re-use.

Tekrarsteriletmeyin.
Dono! resterilize.

T1bb1cihaz
Medical□evice

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INSTRUCTION FOR USE OF KONIX LIDO e STERILE CATHETER GEL

1I

PROOUCT NAME:
DESCRIPTION:

and anesthetic properties u.sed to facilitate the in.sertion of catheters and other medicai instruments (catheterization,
intothe urethra and bladder.
lt helps preventing trauma, which may occur during the catheterization between the urethral mucoS3 and catheter, by
lubricating effect.
associateci

INCiREOIENT:

Deionized Water, Hydroxyethyl Cellulose (Lubricative), Mono Propylene Glycol (Moisturizer),2g Lidocaine (Locai anesthetic),0.05
g Chlorhexidine Gluconate {Anti.septic), Metll),'1 Hydroxybenzoate (Preservative), Propyl Hydroxybenzoate (Preservative)

APPLICATION:

1. wash your handsand prepare an area that is aseptic as possibleto performthe operati on. Prepare a clean serving trayand piace
required

2. Removethesyringe
children, while 12 ml S)'l'inge and 125 g accordion sylinge are suitable far use in men.

3. Lightly pres.s on the plunger before removing the blue cap
syringe, breakofftheapplicatortip.

4.

Carefully insertthe eone

S.Applythe remaining gel tothesurface ofthecatheterortothesurface ofanother medicai device.

6. Konix Lido e Sterile catheter Gel shONS lubricative effect assoon astlle application starts. ltsanesthetic effectstarts3-5 minutes
later.

7. lfmore gel has to
maybe relatedtoser\Sitivit;yofchlorhexidine mLJSt betaken intocare bythe physician.
B. When the whole product is not used, the syringe and the remaining gel should be evaluated and discarded like other medicai
wastes.

9.

Konix Udo C Sterile

CONTRAINOICATIONS:

components or patients with marked bradycardial rhythm disorders. Konix Lido e Sterile Catheter Gel should not be used in
patientswith severe cardiac insufficiency, severe hepatic and renai dy.;function, traumatic mucosa and / or inflammation / .sepsis
atthe

WARNINCiSAND PRECAUTIONS FOA USE

•

Underanesthesia a lubricantwithout lidocaineshould be used.

•

lnstilllation should only be performed
, Patients
susceptibleto drug induced methaemiglobinaemia.

-When applying Konix Lido e Sterile Catheter Gel, a temporary burn may occur; patients should be warned in this regard. In this
case, cold compress

-Allergie reactionsto lidocaineand / or chlorhexidine mayrarelyoccur. Please consultyour doctor if redness, buming and stinging
occurs in the applied site.

•

lrritateseyesand/or skin in caseof directcontact. Washwith plentyofwater in

• lf swallowed, seek medicai advice.

•

KeepcNi1ayfrom children.

•

Stare in dryand cool places.
,

KeepcNiléfffrom directsunlight.

•

Forsingle useonly.

•

Do not re-sterilize.

-

Do not use productswith damaged packages because ofthe risk ofsterilization deteriorati on.
PRECNANCY
assessment should be performed
however, therapeutic dose used in Konix Lido e Sterile Gatheter Gel does not generally pose a riskto the fetus and infants.

DRUCi INTERACTION

,

lnteraction due to absorption of lidocaine may occur when
Propranolol: Reduction in
Cimetidine: Reduction in plasma clearanceof lidocaine
Antiarrhythmic products: lncrease in toxicityof lidocaine
Phenytoin or barbiturates: Reduction in plasma levelsof lidocaine
The
reported when administered at the recommended doses.

•

Due to the risk ofinteraction depending on chlorhexidine, use with the follovving is not recommended;
Chlorhexidine Gluconate (CHX) + Sodium Hypochlorite (NaOCI)
Chlorhexidine Gluconate (CHX) + Hydrogen Peroxide (H202)
Chlorhexidine Gluconate (CHX) + Povidone-lodine (BTD)
According to scientific literatures. CHX + NaOCI interaction is known to produce toxic by-products far humans.

SIDE EFFECTS:

are possible, Skin reactions depending on anaphylaxis (hypersensitivity) may occur
mucosa.Systemic adverse reactionsto lidocaineare rareand mayresuttfrom hypersensitivityordiminishedtolerance.
PACKACINC

-Konix Lido C Sterile CatheterGel issupplied as sterile in disposable packages, prefilled in 6
125 g accordion syringe.

-Konix Lido e Sterile Catheter Gel 6 ml (25 x 6 ml/ Box]
,

Konix Lido e SterileCatheterGell2 ml (2Sxl2 ml/Box)

•

Konix Lido C Sterile Catheter Gel 125 g

STERILIZATION:

do not use since it will lose the steriity.

Oretid

Manufacturer

OretimTarihi
DateofManufacture

Sonkullanmatarihi[ay/y1ll

Expiration

Konìx

Lido C Sterile Catheter Gel

Konix Udo e Sterile Catheter Gel is a sterile \Nater soluble, non-irritatlng lubricant gel with supportrve antiseptic

reduces

lt

with the

procedure

100 g of Konix Udo e Sterile catheter

materials.

(6

ml,72 ml and725g) from itssterile package bytearing

be used,

Catheter

Konix Lido e Sterile catheter Gel should not be used in patients with hypersensitivity to any of the

application site,

specified interactionscan be seen

and

with glucose-6-phospate

to

the applied region can alleviate the burning sensation.

ANO LACTATlON:

Allergie reactions to lidocaine and chlorhexidine are extremely rare. In the case of hypersensitivity, skin reactions

Konix Lido e Sterile catheter Gel issterilize<:l with radiation

Date (Months/

Yearl

risk by antiseptic

infection
by

locai anesthetic property

ofthe

syringe into the urethral opening and slavvly inject the gel

condition ofthe

Gel should only be used under the supervision of specialist health personnel.

in patients with

Konix Lido C Sterile Catheter Gel can be used during pregnancy and lactation. The risk/benefit

by

plasma clearance of lidocaine

Gel

applied

tissue, age ofthe patient and any adverse condition ofthe patient

a tendencyto

by

a physician or

dehydrogenase

e

..

Turkuaz Sag_l_Ik Hizmetleri, Medikal, Temizlik
Kimyasal Urunler San. ve Tic. A.S.
Akçaburgaz Mah. Muhsin . Yaz,c1oglu Cad.
No:45/5 34522 Esenyurt / Istanbul / Turkiye
T [phone]

[e-mail] / www.turkuazsaglik.com.tr

deficiency

the physician. Udocaine passes to placenta and enters breast milk in small quantities;

in long-term

use and repeated

(25

xl25 g / Box)

93/42/EEC T1bbi CihazyOnebneliOine gore
CE belgelendirici kurulu� numaras1 "2292" dir.

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of chlorhexidine and helps reducing

property

lt minimizes

lidocaine.

of

contains;

provide more even and gentle application. Far the accordion

to

convulsi on (epilepsy;

by

qualified medicai personnel.

or congenita!

used

in combination wìth the follavving drugs;

high

doses. No

a-fter

discomfort

patient

off.

6 ml syringe issuitablefor use in women and

by

applying gentle and even pressure.

shocks). Do

severe

or idiopathic

caseofexposure.

the

not use

methaemoglobinaemia are

dinically significant

to the use of lidocaine in the damaged

due

ml

g),

(rll 6

packaging.

case

In

f:1 k-

Pbx

212 428 6853

F +90

cystoscopy)

perioperative

by

caused

procedure.

in children

under 2years

ha'-Aa'

interactions

ml

12

(rll 12g] syringes and

the package damaged,

pain

which

more

been

PROSPEKTUS/IFU

0R0NKODU

ORONISMI

MALZEME CINSI

CiRECElli KUTU ì>Lç0s0 : STAND KATLAMA : 2KIRIM

RENK

AçlKLAMA/NOT

: 150.06.05.0575

: KONIX 6·12 ML STERIL KATETER LIDO C JEL ORTAK PROSPEICl'US • VENI

:

70 CR

1.

HAMUR

BLACK

:

ADRES

0Lç0

!'Jturkuaz

Healthcare

Tarih: 27 I 10 I 2021

:

210X297 MM

Turkuaz SaglIk Hizmetleri, Medikal, Temizlik Kimyasal OrOnler San. ve Tic. A.S.

T [phone] Pbx F [phone] [e-mail]/www.turkuazsagllk.com.tr

Akçaburgaz Mah. Muhsin Yaz,c1oglu Cad. No:45/5 34522 Esenyurt / istanbul / TOrkiye