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

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Chlorhexidine gluconate; Isopropyl alcohol

Boleh didapati daripada:

Becton Dickinson France

Kod ATC:

D08AC; D08AC52

INN (Nama Antarabangsa):

Chlorhexidine gluconate; Isopropyl alcohol

Dos:

2/70 percent

Borang farmaseutikal:

Cutaneous solution

Jenis preskripsi:

Product not subject to medical prescription

Kawasan terapeutik:

Biguanides and amidines; chlorhexidine, combinations

Status kebenaran:

Marketed

Tarikh kebenaran:

2010-07-02

Risalah maklumat

25
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
washed quickly with plenty of
water.
- on

Ciri produk

Health Products Regulatory Authority
06 November 2020
CRN00C0VH
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 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
06 November 2020
CRN00C0VH
Page 2 of 7
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 ap