Proflavine Cream 0.1%
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Proflavine Cream 0.1%
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Proflavine Hemisulphate BPC 0.1% w/w
3 PHARMACEUTICAL FORM
Cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For treatment of infected wounds and for skin disinfection
4.2 Posology and method of administration
For topical use
Adults, including the elderly and children over 2 years of age
To be applied to the affected part 2 - 3 times daily or as directed by a medical
practitioner.
4.3 Contraindications
The product should not be used if there is a known hypersensitivity to proflavine.
4.4 Special warnings and precautions for use
The bottle should be well shaken before use Prolonged use should be avoided The product contains Lanolin External use only
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Pregnancy and lactation
Can be used during pregnancy and lactation
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
The product will stain clothing
4.9 Overdose
If the product is accidentally ingested, an emetic should be given and medical advice sought.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Proflavine hemisulphate is an acridine derivative with slow acting disinfectant activity. It is bacteriastatic against many Gram-positive bacteria
5.2 Pharmacokinetic properties
None stated
5.3 Preclinical safety data
None stated
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
67.3%w/w
2.5%w/w
5.0%w/w
0.1%w/w
1.0%w/w
24%w/w
Liquid Paraffin BP Yellow Beeswax BP Wool Fat (Lanolin) BP Chlorocresol BP Phenoxyethanol BP Purified Water BP
6.2 Incompatibilities
None known
6.3 Shelf life
2 years in unopened containers Use within 3 months of initial opening
6.4 Special precautions for storage
Store below 25 °C Do not freeze
6.5 Nature and contents of container
100 and 200ml pack sizes: amber glass with plastic cone lined caps
500ml and 2 litre pack sizes: amber high density polyethylene bottles and plastic caps
6.6 Special precautions for disposal
Use as indicated on the label
7 MARKETING AUTHORISATION HOLDER
Ayrton Saunders
9 Arkwright Road
Astmoor Industrial Estate
Runcorn
Cheshire
WA7 1NU
8 MARKETING AUTHORISATION NUMBER
PL 16431/0175
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/07/1990
10 DATE OF REVISION OF THE TEXT
03/11/2009