Klorhexidin Fresenius Kabi
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Klorhexidin Fresenius Kabi 0.5 mg/ml cutaneous solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 0.5 mg chlorhexidine diacetate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL form
Cutaneous solution
4. Clinical particulars
4.1 Therapeutic indications
Disinfection of wounds. Disinfection of mucous membrane e.g. in connection with childbirth and of the urethtra prior to catheterisation.
4.2 Posology and method of administration
The amount of chlorhexidine used for the treatment is adjusted according to need.
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 on peritoneum may increase the formation of peritoneal adhesions (see section 5.3).
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 Klorhexidin 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
Klorhexidin Fresenius Kabi has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
|
|
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
Chlorhexidine is an antiseptic with a bactericidal effect against gram-positive and gram-negative bacteria. The solution is more effective against gram-positive than gram-negative bacteria. Bacterial spores, tubercles and viruses are not affected. Sensitive reactions are rare. The solution is aseptically manufactured. It is isotonic and buffered to a pH with optimal bactericidal effect. The effect of chlorhexidine may be reduced in the presence of soap, blood, pus and other organic matter.
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
Sodium acetate trihydrate
Acetic acid
Water for injections
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Shelf life in unopened container: 3 years
6.4 Special precautions for storage
No special precautions for storage.
6.5 Nature and contents of container
Plastic bottle made of polyethylene:
125 ml
250 ml
1000 ml
Microspol for single use made of polypropylene:
20x30 ml
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
If body tempered solution is preferred, the container can be kept in a heating cabinet (+40C) for a period up to one week.
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)
10289
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1985-11-08 / 2011-01-01
10. DATE OF REVISION OF THE TEXT
2015-05-27