ChloraPrep with Tint 2% w/v / 70% v/v cutaneous solution

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

CHLORHEXIDINE GLUCONATE, ISOPROPYL ALCOHOL

Disponibil de la:

Becton Dickinson France 11 Rue Aristide Bergès, 38800 Le Pont de Claix, France

Codul ATC:

D08AC52

INN (nume internaţional):

CHLORHEXIDINE GLUCONATE 20 mg/ml ISOPROPYL ALCOHOL 0.7 mg/ml

Forma farmaceutică:

CUTANEOUS SOLUTION

Compoziție:

CHLORHEXIDINE GLUCONATE 20 mg/ml ISOPROPYL ALCOHOL 0.7 mg/ml

Tip de prescriptie medicala:

OTC

Zonă Terapeutică:

ANTISEPTICS AND DISINFECTANTS

Statutul autorizaţiei:

Authorised

Data de autorizare:

2010-02-23

Prospect

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
CHLORAPREP WITH TINT
2% W/V / 70% V/V
CUTANEOUS SOLUTION
CHLORHEXIDINE GLUCONATE / ISOPROPYL ALCOHOL
3 ML / 10.5 ML / 26 ML
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What ChloraPrep with Tint is and what it is used for
2.
What you need to know before you use ChloraPrep with Tint
3.
How to use ChloraPrep with Tint
4.
Possible side effects
5.
How to store ChloraPrep with Tint
6.
Contents of the pack and other information
1.
WHAT CHLORAPREP WITH TINT IS AND WHAT IT IS USED FOR
ChloraPrep with Tint is a cutaneous solution of chlorhexidine
gluconate 2% w/v and isopropyl
alcohol 70% v/v in a plastic applicator with a sponge tip on one end.
The applicator contains a fast
acting antiseptic solution, which is used to disinfect the skin and
help prevent infections before
invasive medical procedures, such as injections, insertion of
catheters and minor or major surgery.
ChloraPrep with Tint contains a tint to colour the skin, which plays
no role in the antiseptic properties
of the solution.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CHLORAPREP WITH TINT
DO NOT USE CHLORAPREP WITH TINT:
-
if you are allergic (hypersensitive) to chlorhexidine gluconate or any
of the other ingredients of
ChloraPrep with Tint, especially if you have a history of possible
chlorhexidine-related allergic
reactions (see Section 6).
WARNINGS AND PRECAUTIONS
ChloraPrep with Tint is for external use only.
ChloraPrep with Tint should not be used:
-
near eyes or delicate linings (mucous membranes), as it may cause
irritation. If it does get into
the eye or the delicate linings to the body passages, it should be
wash

Caracteristicilor produsului

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
ChloraPrep with Tint 2% w/v / 70% v/v cutaneous solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine gluconate 20 mg/ml
Isopropyl alcohol 0.70 ml/ml
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Cutaneous Solution.
Orange Solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The medicinal product is to be used for disinfection of the skin prior
to invasive medical procedures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ChloraPrep with Tint may be used on all age groups and patient
populations.
_Paediatric population _
However, ChloraPrep with Tint should be used with care in newborn
babies, especially those born
prematurely (see also section 4.4, Special warnings and precautions
for use).
One applicator is used containing 3 ml, 10.5 ml or 26 ml of the
ChloraPrep with Tint alcoholic
solution.
Method of administration
For cutaneous use
The choice of applicator will depend on the invasive procedure being
undertaken and the clinician’s
preference.
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APPLICATOR
COVERAGE AREA (CM X
CM)
FOR PROCEDURES SUCH AS
:
3 ml
15 X 15
-
MIDLINE
&
CENTRAL
VENOUS
CATHETER
(CVC) INSERTION AND MAINTENANCE
-
PERITONEAL DIALYSIS SITE CLEANSING
10.5 ml
26 ml
25 X 30
50 X 50
-
MINOR AND MAJOR SURGICAL PROCEDURES
-
IMPLANTABLE DEVICE PLACEMENT
-
PROSTHETIC DEVICE PLACEMENT OR REMOVAL
-
MIDLINE,
PERIPHERAL
INTRAVASCULAR
CENTRAL
CATHETER
(PICC)
&
CVC
INSERTION AND MAINTENANCE
-
CARDIAC
CATHETERISATION
AND
CARDIAC
CATH LAB PROCEDURES
-
INTERVENTIONAL RADIOLOGY PROCEDURE
The applicator is removed from the wrapper and held with the sponge
facing downward. The
applicator is squeezed gently to break the ampoule containing the
antiseptic solution, which is
released onto the sponge in a controlled flow (for the 26 ml
applicator the lever is pressed). Pinch
wings
ONCE ONLY
to activate the applicator and release the antiseptic. Do not
repeatedly pinch or pump
the wings in an attempt to accelera