Antiseptic Liquid
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Savlon Antiseptic Liquid
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients: Cetrimide 3.0% w/v
Chlorhexidine Gluconate 0.3% w/v
3. PHARMACEUTICAL FORM
Liquid
4. Clinical Particulars
4.1. Therapeutic Indications
A general antiseptic for external first-aid use.
4.2. Posology and Method of Administration
Adults, children and elderly:
must be diluted with
2 capfuls (30ml) to a 'A litre of warm water
2 capfuls (30ml) to a A litre of warm water
5 capfuls (75ml) to the bathwater
Savlon Antiseptic Liquid is for external use only and water as follows:
- First aid for cuts, grazes, minor burns and bites
- Personal hygiene and midwifery
- Bathing
4.3.
Contra-Indications
None known.
4.4. Special warnings and precautions for use
Keep all medicines out of the reach of children.
Keep out of the eyes and ears.
Treat accidental splashes by washing open eyes with water for at least ten minutes, seek medical advice.
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 Savlon Antiseptic Liquid, 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
None known.
4.6. Pregnancy and Lactation
No known restriction.
4.7. Effects on Ability to Drive and Use Machines
The ability to drive or use machines is not affected.
4.8 Undesirable effects
In rare cases, skin irritation may occur; stop using and seek medical advice. Chemical burns in neonates (frequency unknown)
4.9 Overdose
If swallowed, wash out of mouth and drink plenty of milk or water; seek medical advice and show the container to the doctor.
5. Pharmacological Properties
5.1. Pharmacodynamic Properties
Chlorhexidine is an effective antiseptic with a wide range of activity against micro organisms, including gram positive and gram negative bacteria, fungi and viruses.
Cetrimide is a quaternary ammonium compound with surfactant and antiseptic properties.
5.2. Pharmacokinetic Properties
Not applicable.
5.3. Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1. List of Excipients
Isopropyl alcohol Terpineol
Liquid deodoriser S53272TP Benzyl benzoate D-Gluconolactone Sodium hydroxide Purified water
6.2. Incompatibilities
None.
6.3 Shelf life
36 months.
6.4. Special Precautions for Storage
Do not store above 25°C
6.5. Nature and Contents of Container
Colourless (clear) or blue (clear) blow moulded PVC plastic bottle with polypropylene screw cap.
White HDPE bottle with a polypropylene screw cap.
Pack sizes: 115 ml, 125 ml, 250 ml, 450 ml, 495 ml, 500 ml, 550 ml, 600 ml, 750 ml,
900 ml, 5000 ml.
6.6 Special precautions for disposal
Medicines should be kept out of the reach of children.
7. MARKETING AUTHORISATION HOLDER
Novartis Consumer Health UK Limited
Trading as Novartis Consumer Health
Wimblehurst Road
Horsham
West Sussex
RH12 5AB
8. MARKETING AUTHORISATION NUMBER
PL 00030/0126
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Date of renewal: 1 November 1997
10 DATE OF REVISION OF THE TEXT
02/06/2015