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

Logo GERMOLENE ANTISEPTIC LIQUID
SCHEDULING STATUS:
Not Scheduled

PROPRIETARY NAME:
(and dosage form)

GERMOLENE ANTISEPTIC LIQUID

COMPOSITION:
        Cetrimide        30 mg/mL;
        Chlorhexidine Gluconate        3 mg/mL;
Contains TARTRAZINE

PHARMACOLOGICAL CLASSIFICATION:
A13.1 Antiseptics, disinfectants, cleansing agents.

PHARMACOLOGICAL ACTION:
Germolene Antiseptic Liquid has antiseptic, detergent and cleansing properties. In vitro studies have shown anti-bacterial properties against E Coli, S Aureus and Ps Aeruginosa.

INDICATIONS:
Antiseptic for cleansing of physically contaminated wounds and burns. Use according to recommended dilution.

CONTRA-INDICATIONS:
Germolene Antiseptic Liquid should not be used in the eye, ear or mucous membranes or body cavities and during neurosurgery, should not be used on the brain, meninges and middle ear.

WARNING:
This product contains FD and C yellow No 5 (Tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of tartrazine sensitivity in The general population is currently thought to be low it is frequently seen in patients who also have aspirin sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
1. For external use only
2. Germolene Antiseptic Liquid must be diluted as directed before application to the skin.
For cleansing of wounds: Dilute 5 mL Germolene Antiseptic Liquid in 100 mL warm water.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Soaps, blood, cotton, cellulose and other organic matter will reduce the effectiveness of Germolene Antiseptic Liquid. Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with Germolene Antiseptic Liquid. An oxidising bleach such as sodium perborate should be used in laundering. Prolonged and repeated applications of Germolene Antiseptic Liquid to the skin are inadvisable as hypersensitivity may occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OT ITS TREATMENT:
Accidental ingestion may cause nausea and vomiting, dyspnoea and cyanosis due to paralysis of the respiratory muscles, possibly leading to asphyxia, depression of the central nervous system with convulsions, hypertension and coma may occur. In the event of ingestion consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible. The latest information regarding the treatment of ingestion can be obtained from the nearest poison centre.

IDENTIFICATION:
Orange clear liquid.

PRESENTATION:
125 mL, 250 mL and 500 mL plastic containers

STORAGE INSTRUCTIONS:
Keep out of reach of children.
Store below 25°C. Protect from light.

REGISTRATION NUMBER:
X/13.1/136

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Group Laboratories SA (Pty) Limited,
21 Wrench Road, Isando 1600

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
22 October 1990

809-1207-01

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