Oxybee - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Oxybee powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder :

Geyerspergerstr. 27

80689 Munich

Germany

Manufacturer responsible for batch release :

Wirtschaftsge­nossenschaft deutscher Tierärzte (WDT) eG

Siemensstraße 14

30827 Garbsen

Germany

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

One bottle of 375 g of solution contains:

Active substance:

Oxalic acid dihydrate 17.5 g (equivalent to 12.5 g of oxalic acid)

Clear and colourless solution.

One bottle of 750 g of solution contains:

Active substance:

Oxalic acid dihydrate 35.0 g (equivalent to 25.0 g of oxalic acid)

Clear and colourless solution.

One sachet of 125 g of powder contains:

Excipients:

Sucrose 125 g

1 ml of mixed bee-hive dispersion contains:

Active substance:

Oxalic acid dihydrate 39.4 mg (equivalent to 28.1 mg of oxalic acid)

Colourless, clear to slightly turbid dispersion.

• 4. INDICATION(S)

For the treatment of varroosis (Varroa destructor) of honey bees (Apis mellifera) in brood-free colonies.

None.

• 6. ADVERSE REACTIONS

In clinical trials, increased bee mortality was very commonly observed. This did not affect long-term development of colonies.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 colonies treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 colonies in 100 colonies treated)

• – uncommon (more than 1 but less than 10 colonies in 1,000 colonies treated)

• – rare (more than 1 but less than 10 colonies in 10,000 colonies treated)

• – very rare (less than 1 colony in 10,000 colonies treated, including isolated reports.

• 7. TARGET SPECIES

Honey bees (Apis mellifera )

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

In-hive use.

Dose:

A maximum dose of 5–6 ml of the final bee-hive dispersion should be administered once per seam occupied by bees. The total amount of product administered to a colony should not exceed 54 ml. Therefore, if necessary, the dose per seam should be reduced in order not to exceed the maximum total amount administered per colony (calculation: maximum dose per colony/number of occupied seams= x.x ml/seam).

The use of Oxybee with the above dosing scheme only applies to hives with vertical frames that can be accessed from the top, as the treatment of bees in other types of hives has not been investigated.

• 9. ADVICE ON CORRECT ADMINISTRATION

The product should be administered using a suitable measuring device with appropriate graduations (e.g. automatic pipette, disposable syringe) onto the bees sitting in seams.

The final bee-hive dispersion is to be trickled onto the bees in the seams.

Dosing should be done carefully and overdosing should be avoided.

The solution should be warm (30 – 35 °C) during application.

The outside temperature during treatment with Oxybee should be at least 3 °C.

Apply only one treatment per hive.

In case the final dispersion had been stored, it should be well shaken before use.

Preparation of the final dispersion:

Before use the content of the sachet(s) containing the flavoured sucrose powder should be added to the bottle containing the solution for bee-hive dispersion as follows:

Place the bottle containing the oxalic acid dihydrate solution into warm (30 – 35 °C) water. Open the sachet(s) of the sucrose powder with a pair of scissors.

Preparation of the 444 ml final bee-hive dispersion: Pour the content of one sachet into the bottle containing 375 g of the oxalic acid dihydrate acid solution.

Preparation of the 888 ml final dispersion: Pour the content of the two sachets into the bottle

containing 750 g of the oxalic acid oxalic dihydrate acid solution.

The full content of the sachet(s) should be poured into the bottle with the solution.

Close the bottle tightly and shake it until the sucrose is completely dissolved. The final bee-hive dispersion should be a colourless, clear to slightly turbid dispersion.

Example of measuring device

• 10. WITHDRAWAL PERIOD(S)

Honey: Zero days.

Do not use during honey flow.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Keep the bottle and the sachet in the outer carton in order to protect from light.

After mixing the bee-hive dispersion: Store in a refrigerator (2 °C – 8 °C).

Store away from food.

Do not use this veterinary medicinal product after the expiry date which is stated on the labels and the cardboard box. The expiry date refers to the last day of that month.

Shelf life after mixing according to directions: 1 year.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

must only be applied only once in brood-free colonies. The veterinary medicinal product should be used as a treatment within an Integrated Varroa Management program with mite drop monitored regularly.

When possible, rotate the use of this product with another approved varroacide with a different mode of action to decrease the potential for Varroa mites to develop resistance.

Special precautions for use in animals:

Do not use higher doses than the recommended dose, and do not administer this veterinary medicinal product more than once. Repeated treatments are not well tolerated by bees. If worker bees are treated more than once per generation, it can result in damage to the bees and a reduction in strength of the colony.

All colonies in the same apiary should be treated simultaneously to avoid re-infestations. Avoid disturbance to the hives the days after treatment.

should not be used when honey supers are present.

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

This veterinary medicinal product is highly acidic and could have irritating and corrosive effects on skin, eyes and mucous membranes.

Avoid oral exposure, including hand-to-mouth contact.

Avoid direct skin and eye contact, as well as hand-to-eye contact.

Personal protective equipment consisting of protective clothing, acid-proof gloves and safety glasses should be worn.

Wash hands and exposed skin with soap and plenty of water immediately. Do not eat, drink or smoke whilst handling and applying the veterinary medicinal product.

Remove contaminated clothing immediately. Used measuring devices and empty containers should be disposed of immediately in a proper way.

In case of accidental ingestion, clean the mouth with water and drink water or milk, but do not induce vomiting. In case of eye contact, immediately rinse the eye thoroughly with water (remove contact lenses first).Seek medical advice immediately and show the package leaflet or the label to the physician.

Oxybee has corrosive properties on corrosion-sensitive parts of beekeeping equipment.

Interaction with other medicinal products and other forms of interaction:

None known.

The concomitant use of other acaricidal products should be avoided because increased toxicity to bees might occur.

Overdose (symptoms, emergency procedures, antidotes) :

After overdosing, increased bee mortality was very commonly observed. An overdose of 53% of the dispersion per treatment resulted in a temporary, short-term increase in bee mortality. The overdose did not significantly affect the development of the colonies in the long term, as shown by the development of the colonies in spring.

Incompatibili­ties:

Do not mix with any other veterinary medicinal product.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

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

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

DD/MM/YYYY

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

• 15. OTHER INFORMATION