SoluPrep with tint 2%w/v/70%v/v cutaneous solution

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Chlorhexidine gluconate; Isopropyl alcohol

Inapatikana kutoka:

3M Deutschland GmbH

ATC kanuni:

D08AC; D08AC52

INN (Jina la Kimataifa):

Chlorhexidine gluconate; Isopropyl alcohol

Kipimo:

20 milligram(s)/millilitre

Dawa fomu:

Cutaneous solution

Eneo la matibabu:

Biguanides and amidines; chlorhexidine, combinations

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2019-08-13

Taarifa za kipeperushi

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SOLUPREP WITH TINT 2% W/V / 70% V/V CUTANEOUS SOLUTION
Chlorhexidine Gluconate / Isopropyl Alcohol
Green tinted solution: 10.5 mL/26 mL in applicator
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 Soluprep with tint is and what it is used for
2.
What you need to know before Soluprep with tint is used
3.
How Soluprep with tint is used
4.
Possible side effects
5.
How to store Soluprep with tint
6.
Contents of the pack and other information
1.
WHAT SOLUPREP WITH TINT IS AND WHAT IT IS USED FOR
Soluprep with tint is a sterile antiseptic solution of chlorhexidine
gluconate 20mg/mL and
isopropyl alcohol 0.70mL/mL in an applicator with a sponge tip on one
end. The applicator
contains a fast acting antiseptic solution, which is used
in subjects aged 1 year and above
to
disinfect the skin before invasive medical procedures (such as
insertion of catheters, minor and
major surgery) to help reduce bacteria that potentially can cause skin
infection.
Soluprep with tint tinted solution contains a tint to colour the skin,
_ _
it plays no role in the
antiseptic properties of the solution.
2.
WHAT YOU NEED TO KNOW BEFORE SOLUPREP WITH TINT IS USED
SOLUPREP WITH TINT MUST NOT BE USED:
-
if you are allergic to chlorhexidine gluconate, isopropyl alcohol or
any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Soluprep with tint is for external use only on intact skin.
The solution is flammable. Do not use electrocautery procedures (i.e.
surgical procedures
where a surgeon or doctor used electricity to heat tissue to prevent
or stop bleeding or remove
abnormal tissue growth) or other ignit

Tabia za bidhaa

Health Products Regulatory Authority
05 December 2023
CRN00DJ3R
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SoluPrep with tint 2%w/v/70%v/v cutaneous solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 20 mg chlorhexidine digluconate and 0.70 mL
isopropyl alcohol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution.
Green tinted solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The medicinal product is to be used in subjects aged 1 year and above
for disinfection of the skin prior to invasive medical
procedures to help reduce bacteria that can potentially cause skin
infection.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For cutaneous use.
SoluPrep may be used in all age groups and patient populations.
However, SoluPrep is not recommended in the paediatric
population less than 1 year old (see Section 4.4 Special warnings and
precautions for use).
Two sized single use applicators are available:
- 10.5 mL green tinted or colourless solution
- 26 mL green tinted solution
The choice of applicator size will depend on the type of invasive
medical procedure being performed and the preference of the
clinician.
As this product does not have presentations of smaller volumes,
prescribers should use alternate products for disinfection of
skin prior to simple invasive procedures that require small volume.
SOLUTION VOLUME (ML)
MAXIMUM COVERAGE AREA (CM X CM)
TO BE USED FOR:
​
10.5
(COLOURLESS)
34 cm x 34 cm
(1156 cm
2
)
Head, neck and small prep areas
- Minor and Major
surgical procedures
- Implantable device
placement
- Prosthetic device
placement or removal
- Midline, peripheral
intravascular central
catheter (PICC), central
venous catheter (CVC)
Health Products Regulatory Authority
05 December 2023
CRN00DJ3R
Page 2 of 8
insertion and
maintenance
- Cardiac
catheterization and
Cardiac Cath Lab
procedure
- Interventional
Radiology procedures
10.5
(GREEN TINTED)
34 cm x 34 cm
(1156 cm
2
)
Head, neck and small prep