Document: Klorhexidinsprit Fresenius Kabi cutaneous solution ENG PL change

• Klorhexidinsprit Fresenius Kabi cutaneous solution PL
• Klorhexidinsprit Fresenius Kabi cutaneous solution ENG PL

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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 medicinebecause 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 inthis leaflet:

Klorhexidinsprit Fresenius Kabi is indicated for disinfection of skin before injection, puncturing of skin, taking samples,surgery and for pre-operativehand disinfection after hand washing with liquid soap.

Chlorhexidine kills or reduces the growth of different types of bacteria.

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.

Pregnancy and breast-feeding

No known risks.

Driving and using machines

No known effects.

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 particularlysensitive 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): severeallergic reaction (hypersensitivity), skinirritation 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 getany side effects, talk to your doctor, pharmacistor nurse.This includesany 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

• 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