Apistan 824 mg Bee Hive Strip

Composition

Active substance:

Tau fluvalinate 824 mg/strip

Excipients:

Bee hive strip

8g polymer strip measuring approximately 25 x 3 x 0.075 cm.

3

Pharmacological properties

4.1 ATCvet code :

Pharmacotherapeutic group:

Antiparasitic products, insecticides and repellents, Ectoparasiticides, including insecticides and repellents, Ectoparasiticides for topical use, including insecticides, Pyrethrins and pyrethroids, tau-fluvalinate.

ATC vet code: QP53AC10

4.2 Pharmacodynamics

Tau-fluvalinate is an ectoparasiticide of the cyano-pyrethroid class of compounds, which act by causing rapid depolarisation of the axonal membranes. The molecule is of low toxicity to honeybees in particular due to the poor fit of the molecule in potential receptor sites in this species. In Varroa destructor, uptake is rapid and death results from hyper-excitability and nervous exhaustion.

Tau-fluvalinate acts by contact. Molecules of the Active Pharmaceutical Ingredient migrate to the strip surface at a proscribed rate, determined by the reservoir loading of the polymer. Bees walk over the strips and pick up surface molecules of tau-fluvalinate. Varroa mites in contact with the bees are subjected to the molecule, which is lethal to mites but of relatively low hazard to bees.

The resistance mechanisms of Varroa mites to tau-fluvalinate can be explained by an increased detoxification due to the monooxygenases in the P450 system. Oxygenases appear to be important for the resistance of Varroa mites to tau-fluvalinate, whereas the influence of esterases appears to be negligible. Other mechanisms, such as the reduced uptake of active substance or modification of the binding site, could also be involved.

4.3 Pharmacokinetics

Although the target species for Apistan vet is the honeybee, the product acts directly upon the Varroa mites associated with the bees. There are no known pharmacokinetic effects in the bees.

3

Target species

The honeybee, Apis mellifera (L.)

3

Indications

Control of varroosis (Varroa destructor (formerly known as Varroa jacobsoni)) in honeybee colonies.

3

Dosage

Dose:

2 Apistan vet strips per brood chamber per beehive.

Administration:

Strips are suspended mid-way between the brood frames so that the bees can walk on both sides of the strip. One strip is suspended between frames 3 & 4 and the other between frames 7 & 8 within the brood chamber.

Treatment duration 6-8 weeks, after which time the strips must be removed and disposed of. The strips should not be removed from the hive for at least 6 weeks. Do not leave the strips in the hive for more than 8 weeks. The treatment period should be kept as short as possible in order to reduce the likelihood of trace residues in brood wax and to avoid the development of mite resistance.

Small and wintering bee colonies and nuclei require one strip only, suspended through the bee or brood cluster.

Strips should not be placed in the honey supers.

The efficacy is maximised if the product is used in late summer after the main honey harvest (when the amount of bee brood present is diminishing). However, in the case of severe infestations, Apistan vet can be used at any time of year.

3

Contraindications

None known.

3

Adverse reactions

Target species: The honeybee, Apis mellifera (L.)

None

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet, immediate packaging for respective contact details.

3

Warnings

Special precautions for safe use in the target species:

Tau-fluvalinate is a lipophilic compound which can accumulate in wax over repeated administrations. Therefore brood frames should be replaced with new foundation on a regular basis to avoid accumulation of residues. In addition, wax from treated colonies must not be recycled for use as foundation in brood or honey frames.

If signs of disease appear or persist then consult your veterinary surgeon or local bee inspector.

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

This veterinary medicinal product can cause skin and eye irritation.

Avoid contact with skin, mouth and eyes.

Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product.

Wash hands thoroughly with soap and water after handling strips or contaminated clothing.

Do not smoke, drink or eat during application.

Special precautions for the protection of the environment:

See section 5.5.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3

Use during pregnancy, lactation or lay

Not applicable.

3

Interactions

None known.

3

Overdose

No treatment specified. In case of doubt, remove product from the colony.

3

Special warnings

Tau-fluvalinate resistance has been observed in some populations of Varroa. Therefore, where feasible, it is recommended to conduct appropriate testing (eg. Vita/NBU test or Beltsville test) to determine whether resistant mites are present prior to treating the colony.

It is recommended to monitor mite-fall before and after administration of the product to determine the effectiveness of the treatment, particularly when it has not been possible to conduct resistance testing prior to the treatment of the colony. It is not recommended to use the product in colonies where mites are known to be resistant to another pyrethroid treatment (e.g. flumethrin), since cross-resistance typically occurs. The product should be used as part of an Integrated Pest Management programme. It is recommended to alternate use with non-pyrethroid varroacides where possible.

3

Withdrawal period

Honey: zero days.

Do not use during honey flow.

Do not extract honey from the brood chamber.

Do not harvest honey when the treatment is in place.

To avoid accumulation of residues in wax, brood frames should be replaced with new foundation on regular basis.

Do not recycle wax from treated colonies for use as foundation in brood or honey frames.

3

Incompatibilities

None known.

3

Immediate packaging

Interior laminated foil pouch holding 10 Apistan vet strips; contained in outer paper pouch bearing the product label.

3

Storage

Keep strips in original, unopened packaging until ready to use.

This veterinary medicinal product does not require any special temperature storage conditions.

Protect from direct sunlight.

Store in original packaging only

Do not store strips near pesticides or other chemical substances which could contaminate the product

Store away from foodstuffs

Replace unused strips in the original packaging

Use strips for one treatment only - do not re-use strips

3

Shelf life

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

3

Disposal of unused product

Medicines should not be disposed of via wastewater.

The veterinary medicinal product should not enter water courses as Tau fluvalinate is EXTREMELY DANGEROUS for fish and other aquatic organisms. Do not contaminate ponds, waterways or ditches with the strips or empty packaging.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

3

Additional information

Vm 17017/5000

8 DATE OF FIRST AUTHORISATION

26 November 1998

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

June 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product not subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 07 July 2026

3

Registration holder

Vita (Europe) Limited

3