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PROFLAVINE CREAM 0.1%

Active substance(s): PROFLAVINE HEMISULPHATE

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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
Liquid Paraffin BP
Yellow Beeswax BP
Wool Fat (Lanolin) BP
Chlorocresol BP
Phenoxyethanol BP
Purified Water BP

67.3%w/w
2.5%w/w
5.0%w/w
0.1%w/w
1.0%w/w
24%w/w

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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