Biotaine In Alcohol Liquid
PDF Leaflet Revision Date: 07 October 2024
Clinical Summary
Quick overview from the medicine insert
Indication
Skin antiseptic.
Dosage (summary)
For external use only; apply undiluted.
Special Populations
- Newborns
- Premature infants
Pregnancy & Breastfeeding
Safety in pregnancy and lactation not established.
Key Drug Interactions
- Do not mix with other substances
- Incompatible with soap and anionic agents
Contraindications
- Not for injection
- Hypersensitivity to ingredients
- Do not use on brain or body cavities
Common side effects
- Ototoxicity
- Skin sensitivity
Counselling Points
- Use only enough to cover the area
- Allow area to dry before proceeding
- Keep away from flames and sunlight
Serious warnings
- Prolonged skin contact may cause burns
- Avoid contact with eyes and ears
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
BIOTAINE IN ALCOHOL is used as a skin antiseptic.
4.2 Posology and method of administration
For external use only. The product is used as follows:
- Concentration of Chlorhexidine Gluconate required
- Use 0,5 % in 70 % alcohol
- Use undiluted
- As a skin antiseptic.
4.3 Contraindications
- Not for injection
- Known hypersensitivity to Chlorhexidine and Propyl alcohol or any other ingredients listed in section 6.1 u201cList of excipientsu201d
- BIOTAINE IN ALCOHOL should not be used on the brain, meninges or middle ear
- Do not use in body cavities.
4.4 Special warnings and precautions for use
For external use only. Prolonged skin contact with alcoholic solutions should be avoided. Only use enough product to cover the area indicated for disinfection. Do not use excessive amounts which can lead to pooling. Allow area to dry before proceeding. Prevent pooling of the product as prolonged skin contact with alcoholic solutions can cause chemical burns. Ensure the area underneath the patient is completely dry, with no BIOTAINE IN ALCOHOL present on linen/linen-savers.
Avoid contact with eyes and ears. In case of contamination of the eyes and ears, wash with fresh clean water, and if irritation continues, consult a doctor. Do not use on open skin wounds, broken or damaged skin. Use with care in newborn babies, especially those born prematurely. It may cause chemical skin burns on these patients. Special precautions must be taken when this product, which contains alcohol, is used where diathermy is indicated. Avoid contamination of food with this product. Keep away from flames and sunlight.
4.5 Interaction with other medicines and other forms of interactions
Do not mix this product with other substances.
4.6 Fertility, pregnancy, and lactation
Studies on fertility, pregnancy and lactation have not been established.
4.7 Effects on ability to drive and use machines
No or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
System Organ Class Frequency Side effects
Ear and labyrinth disorders Frequency unknown Ototoxicity
Skin and subcutaneous tissue disorders Frequency unknown Skin sensitivity
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 to SAHPRA via the u20186.04 Adverse Drug Reactions Reporting Formu2019. Found under SAHPRAu2019s publications: https://www/sahpra.org.za/Publications/Index/8.
4.9 Overdose
Accidental ingestion u2013 empty stomach by aspiration and gastric lavage. Treatment is symptomatic and supportive. See section 4.8 u201cUndesirable effectsu201d.
