Oxuvar 5.7%, 41.0 mg/ml Concentrate for Solution for Honey Bees

Composition

Each ml contains:

Active substance: Oxalic acid 41.0 mg (equal to 57.4 mg oxalic acid dihydrate)

Excipient:

Qualitative composition of excipients and other constituents

Decalcified water

Achromatic, clear solution.

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Pharmacological properties

4.1 ATCvet code: QP 53 AG 03

4.2 Pharmacodynamics

Oxalic acid acts as a contact poison on phoretic Varroa destructor mites. The oxalic acid dihydrate solution is spread topically by physical contact between the bees. The mode of action is not fully understood but it is assumed that the low pH-value of the oxalic acid solution plays an important role.

4.3 Pharmacokinetics

There is evidence that oxalic acid can penetrate the exoskeleton of honey bees. After administration of oxalic acid by trickling, contamination of adult bees was detected at 24 hours, reaching a peak one day later. Steep decreases were observed thereafter, reaching one sixtieth of the peak concentration at 11 days post-treatment. The presence of oxalic acid has been demonstrated in bee haemolymph and the gastrointestinal tract.

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Target species

Honey bee (Apis mellifera)

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Indications

Treatment of varroosis on honey bees (Apis mellifera) due to varroa mites (Varroa destructor).

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Dosage

In-hive use

The veterinary medicinal product must be used as follows:

A) Trickling application

Preparation of the ready-to-use 3.5% (m/V) oxalic acid dihydrate trickling solution:

Pre-warm the oxalic acid dihydrate solution container in a water bath (30–35 °C). Remove it from the water bath and open the sealed container. Add the required amount of sugar (sucrose) as used for feeding the bees:

- 275 g sugar when using the 275 g bottle

- 1 kg sugar when using the 1000 g bottle

Close the container and shake vigorously until the sugar is completely dissolved. The solution is now ready to use and should be applied lukewarm.

Administration:

Fill a syringe (60 ml) or similar device through the wide opening of the container with the needed amount of ready-to-use solution to treat a colony. The dose per comb side is 0.25 ml/dm2 for Western/Central Europe and 0.4 ml/dm2 for Southern Europe.

Amounts of ready-to-use trickling solution per occupied row

For two storey hives, trickle first the lower brood chamber and then the upper brood chamber. The mite drop will continue during 3 weeks.

The ready-to-use trickling solution is enough to treat between 6–15 colonies when using the 275 g bottle or between 20–50 colonies when using the 1000 g bottle. The ready-to-use trickling solution has to be used immediately and cannot be stored after preparation.

B) Spraying application

Preparation of the ready-to-use 3% (m/V) oxalic acid dihydrate spraying solution:

Add tap water to the solution:

- 250 g (250 ml) tap water when using the 275 g bottle

- 900 g (900 ml) tap water when using the 1000 g bottle

Close the container and shake. The solution is now ready to use.

Administration:

Fill a hand sprayer or similar device with the needed amount of ready-to-use solution. Spray 2–4 ml of the solution over each side of the comb that are covered by bees. If only half of the frame is covered with bees the dosage must be reduced by 50%. The maximum dose is 80 ml per hive. The total volume required varies with the hive system:

- Broodless colonies, man-made broodless colonies or swarms newly lodged in hives should be treated with a dose of 0.3 ml/dm2 of comb fully covered with bees and for the most common hives as follows:

Hive system / Amounts of ready-to-use spraying solution per brood frame side covered with bees:

DNM, National, Simplex, WBC, Zander: 2–3 ml

Commercial beehive, Langstroth, Swiss hive: 2.5–3.5 ml

AZ-hive (SI), Dadant: 3–4 ml

- Swarms, artificial swarms in the cluster should be sprayed with 20–25 ml of the ready-to-use spraying solution per kg of bees.

For an accurate dosage spray with your hand sprayer 10 times into a measuring cup and calculate the volume for one pump action. Calculate how many pump actions are required to treat one side of a frame. The combs should be sprayed at a 45° inclination in order to minimize the direct spraying into the cells. The mite drop will continue during 3 weeks.

Treat the swarm, artificial swarm or man-made broodless colony in spring/summer as a single treatment when the majority of bees are inside the hive (in the evening). The ready-to-use spraying solution is enough to treat between 5–10 colonies when using the 275 g bottle or between 25–40 colonies when using the large 1000 g bottle.

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Contraindications

The veterinary medicinal product must not be used on colonies with brood since it is not effective on varroa which are inside brood cells.

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Adverse reactions

Honey bee:

Undetermined frequency (cannot be estimated from the available data):

Increased bee mortality rate1

Agitation of colony

Hive weakness2

1 with the trickling or spraying treatment.

2 slight, in spring with the trickling treatment.

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 immediate packaging for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Avoid disturbance to the hives the days after treatment. If bees are treated more than once per generation, it can result in damage to the bees and a reduction in strength of colony.

The summer treatments of swarms, artificial swarms or man-made broodless colonies must be followed by an autumn or winter treatment against varroa. Do not spray on frames used for honey production in the same season.

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

This veterinary medicinal product is an acidic solution and could cause severe irritation of the skin, eyes and oral and respiratory mucosa. Avoid all direct contact with the veterinary medicinal product, including accidental ingestion and inhalation of the spray mist. Personal protective equipment consisting of protective clothing, chemical resistant gloves and safety glasses should be worn. Additionally, a protective mask type FFP2 should be worn for the spraying application.

In case of accidental ingestion, clean mouth with water and drink afterwards plenty of water or milk. Do not induce vomiting. In case of skin or eye contact immediately rinse thoroughly with water and remove contact lenses. If skin/eye irritation persists, or if the veterinary medicinal product has been inhaled or ingested, seek medical advice immediately and show the package leaflet or the label to the physician.

Special precautions for the protection of the environment:

None.

Other precautions:

The veterinary medicinal product is corrosive to metal parts.

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.

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Use during pregnancy, lactation or lay

Not applicable.

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Interactions

Do not use simultaneously with other acaricides against varroosis.

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Overdose

In Western/Central Europe, one treatment with a dose up to 4.6% (m/V) oxalic acid dihydrate in late autumn is tolerated well. Marginal bee losses are generally compensated by the colony. A significantly higher dose than recommended (higher than 5% (m/V)) can lead to twice the amount of natural bee loss and to a poor survival of the colony in spring. Repeated treatments within the same season can lead to increased bee mortality, a negative effect on brood development and queen loss.

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Special warnings

The efficacy may vary between colonies due to the conditions of use (presence of brood, temperature, reinfestations etc.). The veterinary medicinal product should be used as a treatment within an Integrated Pest Management program with mite drop regularly monitored. The use of different substances for year round treatments is recommended to avoid the risk of resistance.

The trickling application must be used in the broodless colony in autumn/winter as a single treatment at outdoor temperatures between –15 °C and 5 °C.

The spraying application (autumn/winter or spring/summer) must be used in the broodless colony as a single treatment at outdoor temperatures above 8 °C. A second spraying treatment after a 2-week interval is only recommended for heavily infested colonies with a remaining infestation of over 6% after the first treatment. The application of high amounts of oxalic acid could lead to higher bee mortality and queen losses; therefore, the exact dosing is necessary.

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Withdrawal period

Honey: zero days for correctly treated colonies. Administer the treatment without honey supers mounted.

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Incompatibilities

Do not use simultaneously with other acaricides against varroosis. Contact with calcium-containing solutions can lead to precipitations.

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Immediate packaging

Rigid HDPE container closed with an aluminium seal and a PP child-proof cap.

Pack sizes:

500 ml bottle containing 275 g oxalic acid dihydrate solution.

2000 ml bottle containing 1000 g oxalic acid dihydrate solution.

Not all pack sizes may be marketed.

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Storage

Store below 30 °C. Do not refrigerate or freeze. Protect from frost. Store in the original container in an upright position. Keep the bottle tightly closed. Protect from direct sunlight. Discard unused material.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 5 years

Shelf life after first opening of the immediate packaging and reconstitution according to directions:

- Trickling application: once reconstituted with sugar: use immediately.

- Spraying application: once reconstituted with tap water use within one year and within the products expiry date.

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Disposal of unused product

Medicines should not be disposed of via wastewater or household waste.

The veterinary medicinal product should not enter water courses as this may be dangerous for fish and other aquatic organisms.

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.

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Additional information

Vm 36234/4001

8 DATE OF FIRST AUTHORISATION

28 October 2016

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

February 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product not subject to prescription.

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

Approved: 26 March 2025

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Registration holder

Andermatt BioVet GmbH

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