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

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Chlorhexidine gluconate; ISOPROPYL ALCOHOL

Доступно од:

Carefusion U.K. 244 Limited

АТЦ код:

D08AC; D08AC52

INN (Међународно име):

Chlorhexidine gluconate; ISOPROPYL ALCOHOL

Дозирање:

2/70 percent

Фармацеутски облик:

Cutaneous solution

Тип рецептора:

Product not subject to medical prescription

Терапеутска област:

Biguanides and amidines; chlorhexidine, combinations

Статус ауторизације:

Marketed

Датум одобрења:

2010-07-02

Информативни летак

PACKAGE LEAFLET
2
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 (mi

Карактеристике производа

Health Products Regulatory Authority
03 January 2019
CRN008P36
Page 1 of 9
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 20mg/ml
Isopropyl alcohol 0.70ml/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.
Health Products Regulatory Authority
03 January 2019
CRN008P36
Page 2 of 9
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
safely contained within the applicator. The sponge is gently pressed
against the
patient’s skin in order to apply the antiseptic solution. Once the
solution is visible on
the skin, use gentle back and forth strokes to prep the site for 30
seconds. The 26 ml
applicator includes two swabs. Clean intact umbilicus with enclosed
swabs when