Special warnings

All bee colonies in an apiary must be treated at the same time to prevent reinfection by untreated colonies.
The veterinary medicinal product should be used as part of an integrated Varroa control program with regular monitoring of the mite infestation. The use of different substances throughout the year is recommended to avoid the risk of resistance developing.

Special precautions for safe use on target species

Ensure adequate ventilation during treatment. Open the flight opening to at least 15 cm2. Remove all obstacles in front of and behind the flight opening so as not to restrict ventilation.
High acid concentrations can lead to beard formation in front of the Entrance. In this case, reduce the evaporation rate of the evaporator and create a 2 cm high opening across the entire width of the hive to reduce the acid concentration in the hive.
The veterinary medicinal product should not be applied outside the temperature range of 12 to 30 °C.

Special precautions for the user

This veterinary medicinal product irritates the skin, eyes, mucous membranes and respiratory tract. Contact with skin, eyes and mucous membranes and inhalation of vapors should therefore be avoided.
When handling the veterinary medicinal product, the user should wear protective equipment consisting of the usual beekeeping protective clothing as well as protective goggles, chemical-resistant protective gloves and a respiratory mask (FFP2).
After accidental contact Wash skin area immediately with soap and plenty of water and rinse thoroughly. After accidental contact, immediately flush eyes with plenty of clean, running water for 10 minutes. If skin or eye irritation persists, seek medical advice and show the package leaflet or label.
In case of accidental inhalation, if respiratory irritation persists, seek medical advice and show the package leaflet or label.
Always wash hands with soap and water immediately after use.
Persons with known hypersensitivity to formic acid should use the veterinary medicinal product with particular caution.

Special precautions for the environment

Not applicable.

Other precautionary measures

The corrosive effect of formic acid on corrosion-sensitive components and beekeeping equipment must be taken into account.

Interaction with other medicinal products and other interactions

Interactions with other veterinary medicinal products are not known. Do not use at the same time as other acaricides against varroosis.

Overdose (symptoms, emergency measures, antidotes)

The veterinary medicinal product has a low therapeutic range. A higher dose or an excessive evaporation rate can be characterized by unrest in the colony, formation of a bee beard or swarming and usually lead to brood loss, bee mortality and queen loss. If symptoms of an overdose are detected, the formic acid concentration in the hive should be reduced immediately by ventilation and/or reducing the evaporation rate.

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

Not applicable.

Incompatibilities

As no compatibility studies have been carried out, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Contraindications

None.

Side effects

Occasional (1 to 10 colonies / 1000 treated colonies):
- Increase in bee mortality 1
- Reduction in colony strength 1
- Brood losses 2

Rare (1 to 10 colonies / 10,000 treated colonies):
Queen bee loss

1 Moderate and temporary in the first few days of treatment
2 Generally without lasting effects on colony strength and colony performance

The reporting of side effects is important. It enables the continuous monitoring of the
tolerability of a veterinary medicinal product. The reports should preferably be submitted by a veterinarian via
the national reporting system to the Federal Office of Consumer Protection and Food Safety
(BVL) or to the marketing authorization holder. The contact details are given in the last section of the
package leaflet. Notification forms and contact details of the BVL can be found on the website
https://www.vet-uaw.de/ or can be requested by e-mail (uaw@bvl.bund.de).
Veterinarians have the option of electronic reporting on the above-mentioned website.
website.

Type of application and dosage

For use in the hive
Long-term treatment for hives with a volume of approx. 40 L During long-term treatment, the veterinary medicinal product should evaporate as evenly as possible over the treatment period in order to achieve a continuous, varroacidal formic acid concentration in the hive. For this purpose, the veterinary medicine is applied to the bee colonies using suitable applicators (e.g. Nassenheider Classic, Nassenheider Professional, Nassenheider Horizontal, Liebig Evaporator). These applicators allow a continuous evaporation of low doses per time unit over a longer period of time.
The recommended dosage is 12 - 20 ml of the veterinary drug per Boxes and day over a period of 10 days. The minimum dose of 12 ml per day should not be undercut. Short-term exceeding of the recommended dosage for a few days by up to 100 % can be tolerated. A maximum total amount of 200 ml of the veterinary medicinal product (corresponding to 120 g formic acid) for a treatment cycle of hives with a Boxes volume of 40 L should not be exceeded.
should not be exceeded.
As the individual evaporation rates are highly dependent on the temperature, the configuration of the hive and the activity of the colony, the actual evaporation rate must be carefully monitored. For this reason, the amount of formic acid already evaporated should be checked 2 days after the start of treatment and the evaporation area of the applicator adjusted if necessary (by changing the wick size or the area of the wick paper). Depending on the size of the
of the applicator and the individual evaporation rate, it may be necessary to refill the veterinary medicine.
As a rule, the total dose of 80 - 120 g of formic acid evaporates in hives with a volume of approx. 40 L within about 10 days. However, the treatment period can also be shorter or exceed the specified time. Therefore, the actual evaporation rate should be checked and, if necessary, adjusted via the wick size in order not to fall below the minimum daily dose of 8 - 12 g formic acid/day/box, corresponding to 12 - 20 ml of the veterinary medicinal product. The applicator should only be removed when empty.
The recommended dosage is based on a Boxes volume of approx. 40 liters. In general, the veterinary medicinal product should only be applied at daytime temperatures above 12 °C in order to ensure sufficient efficacy. For safety reasons, the maximum daily temperatures should not exceed 30 °C. Treatment should not be started if heavy rainfall or thunderstorms are expected.

It is recommended to check the infestation level even after treatment. If the mite infestation exceeds 5 mites/day, the treatment should be repeated at least 4 weeks apart.

Short-term treatment for hives with a volume of approx. 60 L
Short-term treatment (shock treatment) is intended to achieve high formic acid concentrations in the hive air in the short term. 40 ml of the veterinary drug is applied to a sponge cloth per Boxes. The sponge cloth is placed over the brood combs. The formic acid evaporates within 4 - 8 hours. The treatment should be repeated 4 to a maximum of 5 times at intervals of 7 days. The sponge cloth should be washed out and dried immediately after treatment.
The recommended dosage is based on a Boxes volume of approx. 60 liters. If midsummer temperatures are expected during the course of the treatment period, a short-term treatment should be started in the cooler morning hours. Honey producers should note that certain quality requirements for honey only allow a limited acidity and no taste or odor deviations. It is therefore recommended to carry out the treatment of economic colonies without honey chambers attached or to carry out the treatment after the honey harvest.

Waiting times

Honey: zero days

Pharmacokinetics

The pharmacokinetics of formic acid in honey bees has not been studied.

Distribution and elimination in the hive:
After the formic acid solution is introduced, the formic acid evaporates. In its gaseous state, the active ingredient is distributed throughout the hive and reaches the capped brood.
In the case of long-term treatment using an evaporation aid, the formic acid concentration in the hive air builds up slowly and then ideally remains at a constant level for several days, which is tolerable for the bees but toxic for the mites. In the case of a short-term treatment, the regulating effect of an evaporation aid on the evaporation rate is missing.
evaporation rate. Comparatively high concentrations are reached in the hive air over several hours.
hive air over several hours. The evaporation rate is influenced, among other things, by the temperature in the hive and the evaporation system.
influenced.
The formic acid naturally escapes through the openings of the hive. Part of the formic acid administered is stored in the honey. Formic acid already occurs naturally in the bee colony. It can therefore be assumed that the acid supplied with the treatment is subject to the same biochemical processes as the naturally occurring formic acid.

Special storage instructions

No special storage conditions are required for this veterinary medicinal product.

Special precautions for the disposal of unused medicinal product
or waste materials, if necessary

Unused veterinary medicinal products should preferably be disposed of at hazardous waste collection points. If disposed of together with household waste, it must be ensured that this waste cannot be misused. Veterinary medicinal products must not be disposed of with waste water or via the sewage system.

Children's warning "Keep medicines out of the reach of children"

Name and address of the marketing authorization holder

Serumwerk Bernburg AG, Hallesche Landstraße 105 b, 06406 Bernburg, Phone: +49 (0)3471 860 4300