Informations for option: Sprilon 12.5%W/W /1.04%W/W Cutaneous Spray Suspension, show other option

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1. Sprilon 12.5%W/W /1.04%W/W Cutaneous Spray Suspension
2. Sprilon 12.5%W/W /1.04%W/W Cutaneous Spray Suspension

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Sprilon 12.5% w/w / 1.04% w/w Cutaneous Spray, Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

For full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Cutaneous Spray, Suspension.

White, water-repellant, viscous ointment suspended in a propellant.

4.1. Therapeutic indications

For the prevention and treatment of pressure sores, and skin damage from contact with body fluids e.g. around the perineum, fistulae, colostomies, ileostomies and eczematous area etc.

Protection and treatment of fissures, leg ulcers. Protection of skin beneath plaster casts.

4.2. Posology and method of administration

Shake can well. Spray surfaces at right angles from a distance of 20cm (8“). Two to three seconds should be sufficient for the area the size of the buttocks.

Sprilon can be reapplied as often as necessary.

4.3 Contra-indications

Do not use on patients with known sensitivity to wool fats.

4.4    Special warnings and precautions for use

Avoid inhalation or contact with the eyes. Keep out of the reach and sight of children. If condition is aggravated, discontinue use and consult doctor.

4.5    Interaction with other medicinal products and other forms of interaction

Other topical preparations may disrupt the Sprilon Film.

4.6    Pregnancy and lactation

The safety of Sprilon during pregnancy and lactation has not been established, but use of the product is not considered to be contraindicated during these periods.

4.7    Effects on ability to Drive and Use Machines

Unlikely to produce any effect.

4.8    Undesirable Effects

Skin irritation has been observed on rare occasions.

4.9    Overdose

It is very unlikely that overdose would occur with Sprilon. Theoretically, frequently repeated topical application on the same    site could lead to skin irritation.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Sprilon consists of dimeticone, which has a liquid repellant effect. The zinc oxide ointment base helps to moisturise skin. The spray rapidly forms a white, durable, flexible film which, while protecting the skin and assisting healing, allows normal transepidermal water loss.

Pharmacokinetic Properties

Not applicable

5.3 Preclinical safety data

Not stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

White soft paraffin    BP

Wool fat (anhydrous lanolin)    BP

Liquid paraffin    Ph. Eur.

Cetostearyl alcohol    Ph. Eur.

Wool alcohols (wool wax alcohols)    Ph. Eur.

Dextran CB    HSE

Purified Water    Ph. Eur.

Propellent: butane/propane mix    HSE

6.2    Incompatibilities

None

6.3    Shelf Life

3 years

6.4    Special precautions for storage

Do not store above 25°C. Highly flammable.

The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not pierce the canister.

6.5    Nature and contents of container

Aluminium pressurised can with plastic cap containing 115g of which Sprilon cutaneous spray suspension 60g, or containing 150g of which Sprilon cutaneous spray, suspension 78g.

6.6    Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Ayrton Saunders Ltd

9 Arkwright Road

Astmoor Industrial Estate

Runcorn

Cheshire

WA7 1NU

8. MARKETING AUTHORISATION NUMBER

PL 16431/0020

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

23^rd March 2005

10 DATE OF REVISION OF THE TEXT

09/09/2011