Package leaflet: Information for the user
Klorhexidinsprit Fresenius Kabi 5 mg/ml, cutaneous solution
chlorhexidine digluconate
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told
you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
You must talk to a doctor if you do not feel better or if you feel worse.
What is in this leaflet:
1. What Klorhexidinsprit Fresenius Kabi is and what it is used for
2. What you need to know before you use Klorhexidinsprit Fresenius Kabi
3. How to use Klorhexidinsprit Fresenius Kabi
4. Possible side effects
5. How to store Klorhexidinsprit Fresenius Kabi
6. Contents of the pack and other information
1.
What Klorhexidinsprit Fresenius Kabi is and what it is used for
Klorhexidinsprit Fresenius Kabi is indicated for disinfection of skin before injection, puncturing of skin,
taking samples, surgery and for pre-operative hand disinfection after hand washing with liquid soap.
Chlorhexidine kills or reduces the growth of different types of bacteria.
2.
What you need to know before you use Klorhexidinsprit Fresenius Kabi
Do not use Klorhexidinsprit Fresenius Kabi
if you are allergic to chlorhexidine digluconate or any of the other ingredients of this medicine (listed
in section 6),
in the ear,
in the joints or tendon sheaths,
in the brain or meninges.
Warnings and precautions
The use of chlorhexidine on peritoneum may increase the formation of peritoneal adhesions.
Klorhexidinsprit Fresenius Kabi is flammable. An area prepared with the product must be completely dry
before the use of equipment that can cause sparks.
Children
Use with care in newborn babies, especially those born prematurely. Klorhexidinsprit Fresenius Kabi may
cause chemical skin burns. Do not use excessive quantities and do not allow the solution to pool in skin folds
or drip on sheets or other material in direct contact with the skin. Where occlusive dressings are to be applied
to areas previously exposed to Klorhexidinsprit Fresenius Kabi, care must be taken to ensure no excess
product is present prior to application of the dressing.
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Pregnancy and breast-feeding
No known risks.
Driving and using machines
No known effects.
3.
How to use Klorhexidinsprit Fresenius Kabi
Preoperative hand disinfection: Disinfection of hands and forearms for at least 30 seconds, after prescribed
hand washing.
Disinfection before perforation of the skin: Disinfect the skin surface and let the solution dry before
perforation. Special attention should be given upon puncturing organs which are particularly sensitive to
infection. Effect time is ½-2 minutes.
Preoperative skin disinfection: The operation area must be thoroughly disinfected for 2 minutes and the
surface of the skin must dry before operation.
The effect may be reduced by soap, blood, puss or other organic material.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (may affect up to 1 in 1,000 people): severe allergic reaction (hypersensitivity), skin irritation in form
of contact dermatitis and urticaria.
Not known (frequency cannot be estimated from the available data): chemical burns in neonates.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly (see details below). By reporting side
effects you can help provide more information on the safety of this medicine.
[To be completed nationally]
5.
How to store Klorhexidinsprit Fresenius Kabi
Keep this medicine out of the sight and reach of children.
Do not store above 25 C.
Do not use Klorhexidinsprit Fresenius Kabi after the expiry date which is stated on the label after EXP. The
expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.
6.
Further information
What Klorhexidinsprit Fresenius Kabi contains
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The active substance is chlorhexidine digluconate.
The other ingredients are ethanol and water for injections.
What Klorhexidin Fresenius Kabi looks like and contents of the pack
Plastic bottle (polyethylene): 125 ml, 250 ml, 1000 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Market auhtorisation holder
[To be completed nationally]
Manufacturer
Fresenius Kabi Norge AS
Halden, Norway
This leaflet was last revised in 27 May 2015
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