SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Johnson's Scaly Lotion, Cutaneous Solution.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Pyrethrum Pale Extract (25%) 0.40% w/v

(equivalent to Pyrethrins) 0.10% w/v

Piperonyl Butoxide 1.00% w/v

For full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Cutaneous solution.

Clear, very pale yellow liquid.

4. CLINICAL PARTICULARS

4.1 Target species

Cage birds, e.g. budgerigars and canaries.

4.2 Indications for use, specifying the target species

Treatment of Scaly Face and Scaly Leg (Cnemidocoptes pilae) in cage birds, e.g. budgerigars and canaries.

4.3 Contra-Indications

None.

4.4 Special warnings for each target species

If signs of disease persist or appear, consult a Veterinary Surgeon.

4.5 i) Special precautions for use in animals

For external use only.

Avoid contact with the eyes.

4.5 ii) Special precautions to be taken by the person administering the medicinal product to animals

Avoid contact with eyes.

If eye contact occurs, rinse with clean, fresh water. Seek medical advice if irritation persists. Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

None reported.

4.7 Use during pregnancy, lactation or lay

None stated.

4.8 Interaction with other medicinal products and other forms of interaction

None reported.

4.9 Amounts to be administered and administration route

Directions for use: Apply two to four drops to affected areas, ensuring whole of affected area is treated. A small, clean, dry artists paint brush, or cotton bud, can be used to apply the lotion. Avoid eyes and nostrils. Apply once every two days for a period of 11 days (6 applications). If symptoms reappear, repeat treatment as above. Isolate affected from unaffected birds.

Clean all cages, perches, feed and water containers and other equipment with a disinfectant approved for use in aviaries. If there are other signs of illness or of feather damage, consult a Veterinary Surgeon promptly.

4.10 Overdose (symptoms, emergency procedures, antidotes) if necessary

None stated.

4.11 Withdrawal periods

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

ATC Vet code: QP53AC51

5.1 Pharmacodynamic properties

The plant Pyrethrum is a chrysanthemum; the powdered, dried flower heads contain active principles mainly in the form of pyrethrins. Pyrethrins have insecticidal activity producing both knock-down and mortality in a range of insects, and low mammalian toxicity. Common names: Dalmatian insect powder and Persian insect powder.

Piperonyl butoxide acts as a synergist when combined with pyrethrin and prolongs its action.

5.2 Pharmacokinetic particulars

No other information available.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Terpineol

IndustrialMethylatedSpirits 74 OP

Propylene Glycol

6.2 Incompatibilities

None known.

6.3 Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

6.4 Special precautions for storage

Do not store above 25°C.

Protect from frost.

Protect from direct sunlight.

6.5 Nature and composition of immediate packaging

Pack Size: 15ml

Container: Round white LDPE unprinted

Plug: White one-drop

Cap: White polypropylene

Secondary packaging: Self-adhesive label and solid board carton.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Johnson's Veterinary Products Ltd

5 Reddicap Trading Estate

Sutton Coldfield

West Midlands B75 7DF

8. MARKETING AUTHORISATION NUMBER(S)

Vm01759/4050

9. DATE OF FIRST AUTHORISATION

Date of first Authorisation: 18.02.92

10. DATE OF REVISION OF THE TEXT

February 2012