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

Logo ZEDCHEM PVP-I SOLUTION (LIQUID)

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

ZEDCHEM PVP-I SOLUTION (LIQUID)

COMPOSITION:
Each 100 mL Zedchem PVP-I Solution contains 10 g
povidone-iodine, equivalent to 1 g available iodine.

PHARMACOLOGICAL CLASSIFICATION:
A13.1 Antiseptics and Cleansing Agents.

PHARMACOLOGICAL ACTION:
Povidone-iodine has antiseptic properties. In vitro studies have shown some antiviral activity.

INDICATIONS:
Disinfection of wounds and burns. Pre-operative preparation of the skin and mucous membranes.

CONTRA-INDICATIONS:
Sensitivity to povidone-iodine. Not to be used during pregnancy and lactation.

WARNINGS:
Application of povidone-iodine to large areas should be avoided as excessive absorption may occur. Absorption of iodine from povidone-iodine may interfere with thyroid function tests.

DOSAGE AND DIRECTIONS FOR USE:
Apply undiluted as often as necessary.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The application of povidone-iodine to severe burns or to large areas otherwise denuded of skin may produce systemic adverse effects associated with iodine. Skin sensitivity may occur. Hypothyroidism can result from topical application of povidone-iodine to neonates. Severe metabolic acidosis may occur in patients suffering from burns covering more than 20% of the body area. In such cases discontinue the use of povidone-iodine. The activity of povidone-iodine is reduced in the presence of alkalis.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of acute poisoning from the ingestion of iodine are due mainly to its corrosive effect on the gastro-intestinal tract. Anuria may occur one to three days later or death may be due to circulatory failure, oedema of the glottis, resulting in asphyxia, or pulmonary oedema. The fatal dose is usually 2g to 3g. Treatment is symptomatic and supportive.

IDENTIFICATION:
A dark brown liquid with a characteristic iodine odour.

PRESENTATION:
1 litre, 5 litre plastic containers; 10 mL and 30 mL plastic sachets.

STORAGE INSTRUCTIONS:
Store in air-tight containers below 25°C. Protect from light. Keep out of reach of children.

REGISTRATION NUMBER:
Z/13.1/234

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ZEDCHEM cc
(Reg. No CK 92/22113/23)
Pama House
Main Road P.O. Box 116
STEENBERG STEENBERG
7945 7947
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
15 April 1993

        P601

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996,1997,1998