Hexiprep 2.0% w/v / 70.0% w/v Impregnated Pad

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Chlorhexidine digluconate solution; Isopropyl alcohol

Inapatikana kutoka:

GAMA Healthcare Ireland Ltd

ATC kanuni:

D08AC52

INN (Jina la Kimataifa):

Chlorhexidine digluconate solution; Isopropyl alcohol

Kipimo:

2.0/70.0

Dawa fomu:

Impregnated pad

Eneo la matibabu:

chlorhexidine, combinations

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2021-04-16

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HEXI PREP 2%W/V / 70%V/V)
IMPREGNATED PAD
CHLORHEXIDINE DIGLUCONATE / ISOPROPYL ALCOHOL
_ _
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 HEXI PREP is and what it is used for
2.
What you need to know before you use HEXI PREP
3.
How to use HEXI PREP
4.
Possible side effects
5.
How to store HEXI PREP
6.
Contents of the pack and other information
1.
WHAT HEXI PREP IS AND WHAT IT IS USED FOR?
HEXI PREP is a single-use impregnated pad containing chlorhexidine
digluconate 2% w/v and
isopropyl alcohol 70% v/v. The pad contains a fast acting antiseptic
solution, which is used by
healthcare professionals to disinfect the skin and help prevent
infections before invasive medical
procedures.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HEXI PREP.
DO NOT USE HEXI PREP
-
if you are allergic (hypersensitive) to chlorhexidine digluconate or
isopropy alcohol. (See
Section 6 ‘Further information’ for a full list of ingredients.)
WARNINGS AND PRECAUTIONS:
Talk to your doctor or nurse before using HEXI PREP.
HEXI PREP is for external use only.
HEXI PREP contains chlorhexidine. Chlorhexidine use can result in
severe allergic reactions
(anaphylactic shock). The prevalence of severe allergic reactions is
not known, but available
literature suggests this is likely to be very rare. HEXI PREP should
not be administered to anyone
with a potential history of an allergic reaction to a
chlorhexidine-containing compound.
HEXI PREP should not be used:
-
Near eyes or delicate linings (mucous membranes), as it may cause
irritation. In the case of
contact wash immediately with plenty of water.
-
On broken skin
-
On the part of the ear that is

Tabia za bidhaa

Health Products Regulatory Authority
19 April 2021
CRN00C1XD
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hexiprep 2.0% w/v / 70.0% w/v Impregnated Pad
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of solution contains 20mg chlorhexidine digluconate and 0.7 mL
of isopropyl alcohol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Impregnated Pad
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The medicinal product is to be used for disinfection of the skin prior
to invasive medical procedures that do not require a clean
air environment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HEXI PREP may be used on all age groups and patient populations.
PAEDIATRIC POPULATION
However, HEXI PREP should be used with care in newborn babies,
especially those born prematurely (see also section 4.4,
Special warnings and precautions for use).
One sachet is used containing a pad impregnated with 1.5mL or 3mL of
the HEXI PREP alcoholic solution.
Method of Administration
For cutaneous use.
The choice of HEXI PREP sachet will depend on the size of the area to
be disinfected, the invasive procedure and the clinician's
preference.
SACHET VOLUME / IMPREGNATED PAD SIZE
MAXIMUM COVERAGE AREA
FOR PROCEDURES SUCH AS:
1.5mL (10 cm x 10cm)
10cm x 13cm

blood culture collection,

peripheral cannulation,

peripheral arterial line cannulation,

simple biopsy,

routine venepunctures

dialysis / fistula / graft site cleansing.
3.0mL (20cm x 10cm)
15cm x 15cm

blood culture collection,

peripheral cannulation,

peripheral arterial line cannulation,

midline and central venous catheter (CVC)
insertions and maintenance,

simple biopsy,

routine venepunctures,

dialysis fistula / graft site cleansing,
peritoneal dialysis site cleansing
Health Products Regulatory Authority
19 April 2021
CRN00C1XD
Page 2 of 6

implantable device placement
Where required as part of sterile procedure (e.g. central line
insertion), tear the sachet open and remove