Soluprep 2% w/v / 70% v/v oplossing voor cutaan gebruik

Země: Nizozemsko

Jazyk: nizozemština

Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktivní složka:

CHLOORHEXIDINEDIGLUCONAAT 20 mg/ml SAMENSTELLING overeenkomend met ; CHLOORHEXIDINE 11,3 mg/ml ; ISOPROPYLALCOHOL 0,7 ml/ml

Dostupné s:

3M Deutschland GmbH Carl-Schurz-Straße 1 41453 NEUSS (DUITSLAND)

ATC kód:

D08AC52

INN (Mezinárodní Name):

CHLOORHEXIDINEDIGLUCONAAT 20 mg/ml SAMENSTELLING overeenkomend met ; CHLOORHEXIDINE 11,3 mg/ml ; ISOPROPYLALCOHOL 0,7 ml/ml

Léková forma:

Oplossing voor cutaan gebruik

Složení:

COPOLYMEER VAN ISOOCTYL ACRYLAAT(20,0)-METHYL METHACRYLAAT(65,0)-N-VINYLPYRROLIDINON(15,0) ; TRIBUTYLACETYLCITRAAT ; Trinatrium N-(2-hydroxyethyl)ethyleendiamine- N,N',N'-triacetaat 2,5-Water ; WATER, GEZUIVERD

Podání:

Cutaan gebruik

Terapeutické oblasti:

Chlorhexidine, Combinations

Datum autorizace:

1900-01-01

Informace pro uživatele

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SOLUPREP 2% W/V / 70% V/V OPLOSSING VOOR CUTAAN GEBRUIK
SOLUPREP GETINT 2% W/V / 70% V/V OPLOSSING VOOR CUTAAN GEBRUIK
Chlorhexidine Gluconate / Isopropyl Alcohol
Colourless solution: 10.5 mL in applicator
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 is and what it is used for
2.
What you need to know before is used
3.
How is used
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
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.
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 IS USED
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
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 t

Charakteristika produktu

2
1.
NAME OF THE MEDICINAL PRODUCT
Soluprep 2% w/v / 70% v/v oplossing voor cutaan gebruik
Soluprep getint 2% w/v / 70% v/v oplossing voor cutaan gebruik
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.
Colourless solution.
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.
may be used in all age groups and patient populations.
However,
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.
3
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) 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
areas
26
(GREEN TINTED ONLY)
50 cm x 50 cm