ChloraPrep with Tint 2% w/v/70% v/v Cutaneous Solution

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Disponible des:

CareFusion U.K.

Codi ATC:

D08AC52

Designació comuna internacional (DCI):

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

formulario farmacéutico:

CUTANEOUS SOLUTION

Composición:

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

tipo de receta:

OTC

Área terapéutica:

ANTISEPTICS AND DISINFECTANTS

Estat d'Autorització:

Authorised

Data d'autorització:

2010-02-23

Informació per a l'usuari

Page 1 of 6
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. (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
washed quickly with plenty of
water.
-
on open skin wounds.
-
on the part of the ear that is inside the body (middle

Fitxa tècnica

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
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
For cutaneous use.
ChloraPrep with Tint may be used on all age groups and patient
populations. 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.
The choice of applicator will depend on the invasive procedure being
undertaken and the clinician’s
preference.
Page 2 of 7
APPLICATOR
MAXIMUM 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 accelerate the saturation of the foam.
The broken ampoule remains