API-Bioxal 0.71 g/g Bee-hive Powder

Composition

Each g contains:

Active substance:

0.71 g oxalic acid equivalent to 0.995 g of oxalic acid dihydrate

Excipients:

White fine powder.

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Pharmacological properties

4.1 ATCvet code: QP53AG03

4.2 Pharmacodynamics

Oxalic acid is an organic acid. Oxalic acid is highly effective against phoretic varroa mites. Studies on the mode of action of oxalic acid have indicated that its low pH is a major contributor to the acaricidal effect. Oxalic acid has been shown to concentrate on mite legs and the edges of the exoskeleton, but none was detected in the alimentary system of mites. Therefore, mites are thought to receive the acid by contact.

4.3 Pharmacokinetics

Oxalic acid, the active ingredient of the veterinary medicinal product, is a natural honey constituent and its concentration in honey depends on the botanical source. No increase of oxalic acid residues over the natural content of honey is to be expected as a consequence of proper veterinary medicinal product administration. After veterinary medicinal product treatments, oxalic acid distributes into the intestine and haemolymph of honeybees where its concentration rises temporarily.

When 4.4% oxalic acid (in 60% sucrose syrup) was administered by trickling, peak contamination of worker bees occurred within 4 days post-treatment, declining to 9% and 2% of the maximum value at 7 and 11 days post-treatment, respectively. Oxalic acid was detected in the alimentary system and haemolymph of bees. Administration of oxalic acid by sublimation resulted in lower intestinal levels and a faster decline of total levels compared to trickling.

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Target species

Honey bees (Apis mellifera).

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Indications

Treatment of varroosis caused by Varroa destructor in honey bees (Apis mellifera).

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Dosage

In-hive use, the veterinary medicinal product must be used as follows:

A) Posology and method of administration by trickling:

The dosage required is 5 ml per seam (gap between top bars of frames) of bees. Maximal dose is 50 ml per hive. Up to two treatments per year (winter and/or spring-summer season in brood-free colonies). The treatment should be made in a single administration. The veterinary medicinal product should be administered using a syringe along the length of each seam of bees.

To prepare the solution, open the bag wearing proper protective mask, gloves and glasses. Pour all the powder in the indicated amount of syrup (water and sucrose in a 1:1 ratio) and mix until dissolution. Concentration of the solution: 4.4% w/v oxalic acid in 60% w/v sucrose syrup (i.e. one bag of 31 g in 500 ml sucrose syrup that is constituted with 308 ml of water and 308 g of sucrose)”.

- bag 31 g: dissolve in 500 ml of syrup (treatment for around 10 beehives).

- bag 156 g: dissolve in 2.5 l of syrup (treatment for around 50 beehives).

- bag 312 g: dissolve in 5.0 l of syrup (treatment for around 100 beehives).

B) Posology and method of administration by vaporisation

Dose is 2 g per hive as a single administration. Maximal dose 2 g per hive as a single administration. One treatment per year.

Use an electric resistance device for vaporisation. It is recommended to follow manufacturer’s instructions in order to achieve maximum sublimation.

Fill the pan of the vaporizer with 2 g of the veterinary medicinal product following the manufacturer’s instructions. Keep the hive shut after the treatment for 15 minutes to avoid escape of the bees and smoke. Use drinkable water for cooling and/or cleaning.

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Contraindications

None.

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Adverse reactions

Honey bees:

Very common (>1 colony/ 10 colonies treated):

- Bee systemic disorder 1;2;

1 Slight agitation of colony during treatment

2 Increased adult bee mortality rate after 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:

Administer the treatment without supers. All colonies in the same apiary should be treated simultaneously to avoid reinfestations. Avoid disturbance to the hives during the days after the treatment. Use of the sublimation method of administration is not recommended in summer.

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

The veterinary medicinal product may be irritant to the skin, eyes and respiratory tract, or cause contact dermatitis. Avoid contact with the skin, eyes, mucous membranes and inhalation.

Personal protective equipment consisting of protective mask conforming to European standard EN149 (type FFP2), protective gloves and protective glasses should be worn when handling the veterinary medicinal product (both during vaporisation and pre-treatment phases). After application, wash hands and any skin that comes into contact with the veterinary medicinal product with soap and water. Thoroughly wash any clothing that comes into contact with the veterinary medicinal product. In case of eye contact, wash the eyes thoroughly with large amounts of clean running water and seek medical advice.

Do not inhale. In case of accidental inhalation, breathe fresh air.

If you have difficulty breathing, seek medical advice and show the physician this warning.

In case of ingestion, do not induce vomiting, but seek medical advice and show the physician this warning.

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

Special precautions for the protection of the environment:

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

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.

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Overdose

Significantly higher bee mortality was observed in hives that received double (by sublimation) or triple (by trickling) dosages of veterinary medicinal product. In addition, when overdosed, the over-wintering capacity of colonies was diminished and there may be detrimental effects on colony development in the future.

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Special warnings

For greatest efficacy, the veterinary medicinal product should only be used when the quantity of brood in the colony is non-existent or at its lowest levels. Oxalic acid does not penetrate wax so will not kill mites within capped brood and therefore the presence of brood may noticeably reduce the efficacy of the veterinary medicinal product. As such, the veterinary medicinal product should be used in winter or following manipulation of the colony to produce a broodless state in summer (e.g. by queen caging). With regard to summer treatments following queen caging, highest levels of efficacy were achieved when a caging period of at least 25 days was used, at which point the colonies were completely broodless. Despite proper treatment, seriously damaged colonies may not survive due to the effects of varroa infestation.

Integrated Pest Management Programme

The efficacy may vary between colonies due to the conditions of use (residue presence of brood, temperature, reinfestations etc.). The veterinary medicinal product should therefore be used as a treatment amongst others within an Integrated Pest Management program, and mite drop regularly monitored.

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Withdrawal period

Honey: Zero days.

Do not use in colonies with supers or during honey flow.

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

Multilayer polyester-Aluminium-Polyethylene laminated bags, heat sealed, containing 31 g, 156 g and 312 g of powder.

Pack sizes:

1 x 31 g of powder

1 x 156 g of powder

1 x 312 g of powder

Not all pack sizes may be marketed.

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Storage

Do not refrigerate or freeze.

Store in the original package.

Keep the original package tightly closed in order to protect from light and moisture.

Store away from foodstuffs.

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Shelf life

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

Shelf life after first opening the immediate packaging: 3 months.

Shelf life after reconstitution according to directions: 24 hours.

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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 oxalic acid 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 23101/4001

8 DATE OF FIRST AUTHORISATION

8 September 2015

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

November 2024

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: 16 January 2026

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Registration holder

Chemicals Laif S.P.A

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