Soluprep 20 mg/ml + 0,7 ml/ml Kutan lösning

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

isopropylalkohol; klorhexidindiglukonat

Tillgänglig från:

3M Deutschland GmbH

ATC-kod:

D08AC52

INN (International namn):

isopropyl alcohol; chlorhexidine

Dos:

20 mg/ml + 0,7 ml/ml

Läkemedelsform:

Kutan lösning

Sammansättning:

klorhexidindiglukonat 20 mg Aktiv substans; isopropylalkohol 0,7 ml Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Förfylld applikator, 50 x 10,5 ml

Bemyndigande status:

Godkänd

Tillstånd datum:

2019-02-15

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Soluprep
2% w/v / 70% v/v cutaneous solution
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.
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
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
(2500 cm
2
)
Large prep
areas below the
neck

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 Card