ChloraPrep with Tint solution 26ml applicators

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chlorhexidine gluconate; Isopropyl alcohol

Available from:

Becton, Dickinson UK Ltd

ATC code:

D08AC52

INN (International Name):

Chlorhexidine gluconate; Isopropyl alcohol

Dosage:

20mg/1ml ; 700ml/1litre

Pharmaceutical form:

Cutaneous solution

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13110200; GTIN: 37613203026384

Patient Information leaflet

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 ear).
-
in direct contact with neural tissue (for

Summary of Product characteristics

OBJECT 1
CHLORAPREP WITH TINT
Summary of Product Characteristics Updated 22-Apr-2016 | CareFusion UK
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.
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
25 X 30
- MINOR AND MAJOR SURGICAL PROCEDURES
- IMPLANTABLE DEVICE PLACEMENT
26 ml
50 X 50
- 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 foa