INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo SAVLON HOSPITAL CONCENTRATE (Solution)

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

SAVLON HOSPITAL CONCENTRATE (Solution)

COMPOSITION:
Each 100 mL contains: Chlorhexidine Gluconate 1,5 g
  Cetrimide 15 g
Preservative: n-Propyl Alcohol 3,14% m/v
Contains Benzyl Benzoate as a solvent.

PHARMACOLOGICAL CLASSIFICATION:
A 13.1 Antiseptics and cleansing agents

PHARMACOLOGICAL ACTION:
Chlorhexidine Gluconate is a bisbiguanide antiseptic and disinfectant which is bactericidal or bacteriostatic against gram-positive and gram-negative bacteria. Cetrimide is a quaternary ammonium antiseptic with greater bactericidal activity against gram-positive than gram-negative bacteria.

INDICATIONS:
Cleansing of physically contaminated wounds and burns.
Pre-operative skin disinfection.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. Contact with the eyes, brain, meninges and middle ear should be avoided. It should not be used in body cavities.

WARNINGS:
Do not use undiluted.

DOSAGE AND DIRECTIONS FOR USE:
DILUTE BEFORE USE.
1:100 aqueous solution:
(10 mL made up to 1 litre with water)
Clean instrument disinfection (30 minute immersion).
Treatment of wounds and burns, swabbing in obstetrics.
1:30 aqueous solution:
(33 mL made up to 1 litre with water)
Treatment of wounds and burns where greater antisepsis is required.
1:30 in 70% alcohol:
(33 mL made up to 1 litre with 70% alcohol or white industrial methylated spirits)
Pre-operative skin antisepsis. Emergency disinfection of clean instruments (2 minute immersion).
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
SAVLON HOSPITAL CONCENTRATE
may cause irritation of the conjunctiva and other sensitive tissues. If ingested it may cause nausea and vomiting, oesophageal damage and necrosis. There have been rare reports of burns with concentrated solutions.

Precautions:
Prolonged and repeated applications to the skin are inadvisable as hypersensitivity may occur. The antimicrobial activity may be diminished through incompatibilities with soaps and other anionic materials and with suspending agents, or through adsorption. Its activity may also be reduced in the presence of organic matter.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Toxic symptoms, following accidental ingestion, include dyspnoea and cyanosis due to paralysis of the respiratory muscles, possibly leading to asphyxia. Depression of the central nervous system (sometimes preceded by excitement and convulsions), hypotension, coma and death, may also occur.

Treatment is supportive and symptomatic.

IDENTIFICATION:
A clear orange-yellow liquid with a pine-like odour.

PRESENTATION:
Clear PVC bottles with 250 mLs and 5 litres and HDPE containers with 5 litres.

STORAGE INSTRUCTIONS:
Store Below 25°C
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmedica Laboratories (Pty) Ltd.
Rattray Road
Dawn
East London

DATE OF PUBLICATION OF THIS PACKAGE INSERT:


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