SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Bolfo 0.25% Flea Spray

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

2.1	Active Constituents	mg per g
	Propoxur	2.5

For full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Cutaneous Spray

Colourless to slightly yellowish solution

4. CLINICAL PARTICULARS

4.1 Target species

Dogs and cats

4.2 Indications for use, specifying the target species

For the control of fleas

4.3 Contraindications

Do not use any other insecticide concurrently or within 7 days of last use.

Do not use more often than weekly.

Do not use on puppies and kittens under 12 weeks of age.

Do not use if your pet is unwell or recovering from an illness.

4.4 Special warnings for each target species

Some cats dislike aerosols and might be better treated by another method.

Fleas from pets often infest the animal’s basket, bedding and regular resting areas such as carpets and soft furnishings which should be treated with a suitable insecticide and vacuumed regularly.

4.5 Special precautions for use

For external use only. Keep treated animals away from fires and other sources of heat for at least 30 minutes following spraying and until the fur is totally dry.

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

Propoxur is a cholinesterase inhibitor. Do not use if under medical advice not to work with anticholinesterases.

Store away from food and feed. Do not drink, eat or smoke while using the product.

Highly flammable. Do not spray on a naked flame or any incandescent material. Do not pierce or burn container even when empty.

Do not inhale the product. Use only in well ventilated areas. Do not spray against the wind.

Avoid contact with eyes, skin, mouth and clothing. In case of accidental spillage onto the skin wash with water and soap; in case of accidental spillage into the eyes wash with plenty of water. After treatment remove any contaminated clothing and wash hands, exposed skin and face thoroughly with soap and water.

Do not allow children to get into contact with recently treated animals as long as they are wet. Treated animals should not be allowed to sleep with people, particularly children.

iii) Other precautions

This product is highly toxic for aquatic organisms, birds and bees.

Do not allow freshly treated dogs to swim in water courses.

This product may cause long-term adverse effects in the aquatic environment.

4.6 Adverse reactions (frequency and seriousness)

Occasional skin irritation

4.7 Use during pregnancy, lactation or lay

Do not use during pregnancy.

Do not use on nursing female pets.

Remove fleas from young animals and nursing females by careful use of flea comb.

4.8 Interaction with other medicinal products and other forms of interaction

Do not use any other insecticide concurrently or within 7 days of last use.

4.9 Amounts to be administered and administration route

Spray the whole surface of the animal avoiding the mouth and eyes. Ruffle the coat and spray against the direction of the hair.

Small Dogs (up to 9 kg e.g. terriers) and Cats :	3 second spray.
Medium Dogs (9.1 - 18 kg e.g. collie):	5 second spray.
Large Dogs (over 18 kg e.g. German shepherd):	10 second spray.

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

Signs of overdosage are typical of neurotoxic agents. Treatment should be symptomatic and atropine may prove helpful.

4.11 Withdrawal period

Not applicable, the product is for use in companion animals only.

5. PHARMACOLOGICAL PROPERTIES

Propoxur, 2-isopropoxyphenyl methylcarbamate (CAS 114-26-1) is a carbamate insecticide

ATC Vet code:QP53 AE02

Pharmacological Properties

Propoxur, 2-isopropoxyphenyl methylcarbamate (CAS 114-26-1) is a carbamate insecticide. Its action is to cause a reversible inhibition of acetyl cholinesterase at the parasite nerve synapses.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Propane

Butane

Fresh fragrant essence HR 760712

Isopropyl alcohol

Citric acid anhydrous

6.2 Incompatibilities

None known

6.3 Shelf-life

Shelf-life of the product as packaged for sale:

3 years

6.4 Special precautions for storage

Do not store above 25ºC. Store in a dry place.

Pressurised container: protect from sunlight and do not expose to temperatures exceeding 50ºC.

6.5 Nature and composition of immediate packaging

Container:	Tin plate or internally lacquered aluminium aerosol can containing 153 g.
Closure:	Aerosol valve assembly, Zeichnung 9203 with Kosmos 9169 activator capable of delivering 1.5 g of product per second

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

Dangerous to fish and other aquatic life. Do not contaminate rivers, reservoirs, water courses, dams and other sources of water. Dispose of the unused product, waste material or empty container safely according to local requirements.

7. MARKETING AUTHORISATION HOLDER

Bayer plc

Animal Health Division

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

8. MARKETING AUTHORISATION NUMBER

Vm00010/4091

9. DATE OF FIRST AUTHORISATION

Date:07 October 1992

10. DATE OF REVISION OF THE TEXT

Date:November 2014

APPROVED 19/11/14