Klorhexidinsprit Fresenius Kabi
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Klorhexidinsprit Fresenius Kabi 5 mg/ml cutaneous solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 5 mg chlorhexidine digluconate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL form
Cutaneous solution
4. Clinical particulars
4.1 Therapeutic indications
Disinfection of skin before injection, puncturing of skin, taking samples and surgery. Preoperative hand disinfection after hand washing with liquid soap.
4.2 Posology and method of administration
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.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Chlorhexidine must not be used in the joints,tendon sheaths, brain, meninges or perforated eardrums, because it is neurotoxic.
4.4 Special warnings and special precautions for use
The use of chlorhexidine with alcohol on peritoneum may increase the formation of peritoneal adhesions (see section 5.3).
Chlorhexidine with alcohol is flammable. An area prepared with the product must be completely dry before the use of equipment that can cause sparks.
Paediatric population
The use of chlorhexidine solutions, both alcohol based and aqueous, for skin antisepsis prior to invasive procedures has been associated with chemical burns in neonates. Based on available case reports and the published literature, this risk appears to be higher in preterm infants, especially those born before 32 weeks of gestation and within the first 2 weeks of life.
Remove any soaked materials, drapes or gowns before proceeding with the intervention. Do not use excessive quantities and do not allow the solution to pool in skin folds or under the patient or drip on sheets or other material in direct contact with the patient. 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.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
No known risks.
4.7 Effects on ability to drive and use machines
Klorhexidinsprit Fresenius Kabi has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
|
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Rare (1/10,000 to <1/1,000) |
Not known (cannot be estimated from the available data) |
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Immune system disorders |
Anaphylactic reaction |
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Skin and subcutaneous tissue disorders |
Contact dermatitis and urticaria |
Chemical burns in neonates |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system
[To be completed nationally]
4.9 Overdose
No known risk.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antiseptic and disinfecting agent.
ATC code: D08A C02
Ethyl alcohol (70%) has an antimicrobial effect against gram-positive and gram-negative bacteria, tubercle bacteria and certain viruses (not hepatitis viruses). Combined with chlorhexidinethe disinfection effect is increased and prolonged. Temporary as well as permanent skin flora is reduced and the antimicrobial effect lasts for several hours.
The effect of chlorhexidine may be reduced in the presence of soap, blood, pus and other organic matter.The solution is aseptically manufactured, skin friendly and the pH is 6,5-8,5.
5.2 Pharmacokinetic properties
Formal pharmacokinetic studies have not been performed.
5.3 Preclinical safety data
An animal study has shown increased intestinal adhesion formation after application of chlorhexidine on intestines in rat.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ethanol
Water for injections
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Shelf life in unopened container: 2 years
6.4 Special precautions for storage
Do not store above 25C.
6.5 Nature and contents of container
Plastic bottle made of polyethylene:
125 ml
250 ml
1000 ml
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Fresenius Kabi AB
751 74 Uppsala
Sweden
8. MARKETING AUTHORISATION NUMBER(S)
10162
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1985-02-01 / 2011-01-01
10. DATE OF REVISION OF THE TEXT
2015-05-27