Beaphar Ear Drops, Solution
Revised: February 2012
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Beaphar Ear Drops, 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
Ear drops, solution.
Clear, very pale yellow liquid with odour characteristic of Terpineol.
4. CLINICAL PARTICULARS
4.1 Target species
Dogs and Cats over 12 weeks of age.
4.2 Indications for use, specifying the target species
Treatment of ear mite (Otodectes cynotis) infestation in dogs and cats over 12 weeks of age.
Do not use on puppies and kittens under 12 weeks of age.
4.4 Special warnings for each target species
If signs of ear problems persist or worsen, consult a Veterinary Surgeon immediately.
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)
4.7 Use during pregnancy, lactation or lay
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
Directions for use: for Dogs , Cats, Puppies and Kittens over 12 weeks of age:
The drops should be gently warmed to body heat e.g. by holding bottle in hand for a few minutes before use. Shake bottle, hold above ear and very gently squeeze in 3‑6 drops according to size of animal as shown below.
Cats and very small Dogs ‑ 3 drops Small Dogs ‑ 4 drops
Medium Dogs - 5 drops Large Dogs ‑ 6 drops
Hold head on one side for 15‑20 seconds to allow drops to penetrate ear canal, massaging gently the base of the ear before allowing animal to shake its head. Use daily for 7 days. Always treat both ears, whether infested or not. To ensure complete clearance of mites, a second course of treatment as above may be given one week after the end of the first treatment.
NOTE: Never probe inside the ears as this can cause pain and injury. Any discharge on the outer surface of the ears may be wiped away gently with cotton wool.
4.10 Overdose (symptoms, emergency procedures, antidotes) if necessary
4.11 Withdrawal periods
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Otologicals, Antiparascitics
ATC Vet code: QS02QA
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
Industrial Methylated Spirits 74 OP
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
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION
Date of first Authorisation: 14.02.02
10. DATE OF REVISION OF THE TEXT
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