ProMeris - summary of medicine characteristics

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

3. PHARMACEUTICAL FORM

4. CLINICAL PARTICULARS

4.1 Target species

Do not administer to kittens under 8 weeks of age.

4.4 Special warnings

Avoid contact with the eyes of the cat and avoid oral ingestion by the animal.

For optimum control of flea problems in a multi-pet household, all pets in the household should be treated with a suitable insecticide. In addition it is recommended to treat the environment with a suitable insecticide.

4.5 Special precautions for use

In sick or debilitated animals, use only according to the benefit/risk assessment by the responsible veterinarian.

This veterinary medicinal product is for spot-on application only. Do not administer orally or v other route.

It is important to apply the dose to an area where the animal cannot lick it off. Do not allow animals to groom each other following treatment.

Care should be taken to ensure that the content of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.

Avoid direct contact with skin, eyes or mouth. Wash hands thoroughly after use. In case of accidental spillage onto skin, wash off immediately with soap and water. If the veterinary medicinal product accidentally gets into eyes, they should be thoroughly flushed with water.

Do not smoke, drink or eat while handling the veterinary medicinal product.

Avoid direct contact with treated animals until the application site is dry.

Children should not be allowed to play with treated animals until the application site is dry. It is therefore recommended to treat the animals during the evening. Recently treated animals are not allowed to sleep with owners, especially children.

The solvent in ProMeris may stain certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

4.6 Adverse reactions (frequency* and seriousness)

Hypersalivation may occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within minutes without treatment. Correct application will minimise licking of the application site.

The application of the veterinary medicinal product may produce a local, temporary oily appearance and clumping or spiking of the fur at the application site. A dry residue may also be observed. This is normal and will generally resolve within 1 – 4 days after administration. These changes do not affect the safety or efficacy of the veterinary medicinal product. In rare cases, transient irritation may occur at the site of the product application. In very rare cases temporary local hair loss may occur.

• * – Very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)

• – Common (more than 1 but less than 10 animals in 100 animals)

• – Uncommon (more than 1 but less than 10 animals in 1,000 animals )

• – Rare (more than 1 but less than 10 animals in 10,000 animals)

• – Very rare (less than 1 animal in 10,000 animals, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

Dosage:

The recommended minimum dose is 40 mg metaflumizone/kg bodyweight, equivalent to 0.20ml/kg bodyweight. The following table defines the size of pipette to be used according to the weight of the cat

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

No adverse effects were observed in cats aged 8 weeks and older treated 7 times at two-week intervals with 3–5 times the recommended dose.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES5.1 Pharmacodynamic properties

Pharmacotherapeutic group: ATC Vet Code QP 53AX25

Metaflumizone is an ectoparasiticide belonging to the semicarbazone gro Metaflumizone is a sodium channel antagonist and disrupts nerve functio death of insects. Metaflumizone is active against fleas due to non-systemi on the skin and hair. Maximum efficacy is achieved within 48 hours.

5.2 Pharmacokinetic particulars

After topical administration at a single site on the cat’s neck at the base of the skull, metaflumizone is rapidly distributed throughout the surface of the skin. Maximum concentrations in the hair were generally reached between 1 to 2 days post-treatment and gradually declined through 56 days posttreatment. Metaflumizone was still measurable in the hair 56 days following treatment. These results are consistent with laboratory efficacy studies showing activity for up to 56 days post-treatment.

After topical administration at a single site on the cat’s neck at the base of the skull, metaflumizone levels in plasma were too low to allow the calculation of standard pharmacokinetic parameters.

5.3 Environmental properties

See section 6.6

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Synperonic NCA 830

Dimethyl sulfoxide

Gamma-hexalactone

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

6.4. Special precautions for storage

Do not store above 25°C

6.5 Nature and composition of immediate packaging

The veterinary medicinal product is packaged in individual-dose transparent plastic pipettes overpacked in an aluminium foil package. It is supplied in units of 3 pipettes per cardboard card and one or two cards per cardboard box. All blisters in a box are the same size.

Box of 1 or 2 blister card of 3 × 0.80 ml pipettes

Box of 1 or 2 blister card of 3 × 1.60 ml pipettes

Not all pack sizes may be marketed.

• 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste

materials derived from the use of such products

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

Carefully dispose of used pipettes immediately after use.

7. MARKETING AUTHORISATION HOLDER

Pfizer Limited Ramsgate Road Sandwich

Kent CT13 9NJ United Kingdom

8. MARKETING AUTHORISATION NUMBER(S)

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10 DATE OF REVISI

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines