Dany's BienenWohl
Authorised
This medicine is authorised for use in the European Union
oxalic acid dihydrate
MedicineVeterinaryAuthorised
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
Dany’s BienenWohl is a medicine used to treat varroosis in honey bee colonies. Varroosis is a disease of honey bees caused by infestation with a parasite called varroa mite (Varroa destructor). The varroa mite feeds on the haemolymph (blood) of adult bees and on brood (developing stages of the honey bee) resulting in harm and/or death of bees. The mite can also help spread viruses and bacteria. A significant mite infestation can lead to the collapse of a honey bee colony. Dany’s BienenWohl can only be used on colonies without brood and should be used as part of a wider management programme. If possible, the use of Dany’s BienenWohl should be alternated with another medicine that kills mites in a different way to reduce the chance of the mites developing resistance.
Dany’s BienenWohl contains the active substance oxalic acid. This medicine is the same as Oxybee, which is already authorised in the European Union (EU). The company that makes Oxybee has agreed that its scientific data can be used for Dany’s BienenWohl (‘informed consent’).
Dany’s BienenWohl is available as a powder and solution to prepare a bee-hive dispersion (a liquid for use inside the bee hive) and can be obtained without a prescription. Up to 6 ml of Dany’s BienenWohl are trickled onto bees in the hive and should only be used when the temperature outside the hives is at least 3?C. The dispersion should be warmed to 30-35?C before application.
For more information about using Dany’s BienenWohl, see the package leaflet or contact your veterinarian or pharmacist.
How oxalic acid works on mites is not well understood but it is thought that the activity of oxalic acid on mites is due to the acidity of the medicine, which kills the mites on contact.
The effectiveness of Dany’s BienenWohl against varroa mites was investigated in two field studies in European countries with different climates. In the first study treatment with Dany’s BienenWohl was compared to another oxalic acid medicine and to a group with no treatment whilst in the second study treatment with Dany’s BienenWohl was compared to a group with no treatment. Three weeks of treatment Dany’s BienenWohl led to the death of 97 and 95 % of the mites.
The most common side effect with Dany’s BienenWohl (which may affect more than 1 in 10 bee colonies) is an increased number of bee deaths. This did not affect long-term development of colonies.
For the full list of restrictions, see the package leaflet.
Dany’s BienenWohl is highly acidic and could be irritating or corrosive to the skin, eyes and mucous membranes (inner lining of body cavities like the mouth or nose). Contact with these areas should be avoided, both directly and by hand-to-mouth or hand-to-eye contact. Protective clothing, acid resistant gloves and safety glasses should be worn during treatment. Contaminated clothing should be removed immediately. Hands and exposed skin should be washed with soap and plenty of water immediately. People must not eat, drink or smoke while using the medicine. Used measuring devices and empty containers should be disposed of immediately in a safe way.
If the product is accidentally swallowed by a person, their mouth should be cleaned with water and water or milk should be drunk, but vomiting should not be induced. In case of eye contact, the affected eye should be rinsed thoroughly with water (contact lenses should be removed first). Medical advice should be sought immediately and the package leaflet or label shown to the doctor.
The withdrawal period is the time required after administration of a medicine before honey may be used for human consumption.
The withdrawal period for honey from honey bees treated with Dany’s BienenWohl is ‘zero’ days, which means that there is no mandatory waiting time.
The European Medicines Agency concluded that Dany’s BienenWohl’s benefits are greater than its risks and it can be authorised for use in the EU.
Dany’s BienenWohl received a marketing authorisation valid throughout the EU on 14 June 2018.
This authorisation was based on the authorisation granted to Oxybee in 2018 (‘informed consent’).
Further information on Dany’s BienenWohl can be found on the Agency’s website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Product information
14/06/2018
Product details
- Name of medicine
- Dany's BienenWohl
- Active substance
- oxalic acid dihydrate
- International non-proprietary name (INN) or common name
- oxalic acid dihydrate
- Species
- Honey bees
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QP53AG03
Pharmacotherapeutic group
- Ectoparasiticides for topical use, incl. insecticides
- Ectoparaciticides, insecticides and repellents
Therapeutic indication
For the treatment of varroosis (Varroa destructor) of honey bees (Apis mellifera) in brood-free colonies.
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