Oxybee

oxalic acid dehydrate

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This is a summary of the European public assessment report (EPAR) for Oxybee. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Oxybee.

For practical information about using Oxybee, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is Oxybee and what is it used for?

Oxybee 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. Oxybee can only be used on colonies without brood.

Oxybee contains the active substance oxalic acid.

How is Oxybee used?

Oxybee 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. Oxybee is 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 further information, see the package leaflet.

How does Oxybee work?

How oxalic acid works on mites is not well understood but is thought to be due to the acidity of the medicine, which kills the mites on contact.

What benefits of Oxybee have been shown in studies?

The effectiveness of Oxybee against varroa mites was investigated in two field studies in European countries with different climates. In the first study treatment with Oxybee was compared to another oxalic acid medicine and to a group with no treatment whilst in the second study treatment with Oxybee was compared to a group with no treatment. Dead mites were counted daily in the first study and three times per week in the second study for three weeks post treatment. The effectiveness of Oxybee to kill mites was 97% and 95% in these studies.

What are the risks associated with Oxybee?

The most common side effect with Oxybee (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.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Oxybee 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.

What is the withdrawal period in food-producing animals?

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 Oxybee is ‘zero’ days, which means there is no mandatory waiting time.

Why is Oxybee approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Oxybee’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Oxybee

The European Commission granted a marketing authorisation valid throughout the EU for Oxybee on 1 February 2018.

For more information about treatment with Oxybee, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Oxybee : EPAR - Summary for the public BG = bălgarski 2018-03-13  
Oxybee : EPAR - Summary for the public ES = español 2018-03-13  
Oxybee : EPAR - Summary for the public CS = čeština 2018-03-13  
Oxybee : EPAR - Summary for the public DA = dansk 2018-03-13  
Oxybee : EPAR - Summary for the public DE = Deutsch 2018-03-13  
Oxybee : EPAR - Summary for the public ET = eesti keel 2018-03-13  
Oxybee : EPAR - Summary for the public EL = elliniká 2018-03-13  
Oxybee : EPAR - Summary for the public EN = English 2018-03-13  
Oxybee : EPAR - Summary for the public FR = français 2018-03-13  
Oxybee : EPAR - Summary for the public IT = italiano 2018-03-13  
Oxybee : EPAR - Summary for the public LV = latviešu valoda 2018-03-13  
Oxybee : EPAR - Summary for the public LT = lietuvių kalba 2018-03-13  
Oxybee : EPAR - Summary for the public HU = magyar 2018-03-13  
Oxybee : EPAR - Summary for the public MT = Malti 2018-03-13  
Oxybee : EPAR - Summary for the public NL = Nederlands 2018-03-13  
Oxybee : EPAR - Summary for the public PL = polski 2018-03-13  
Oxybee : EPAR - Summary for the public PT = português 2018-03-13  
Oxybee : EPAR - Summary for the public RO = română 2018-03-13  
Oxybee : EPAR - Summary for the public SK = slovenčina 2018-03-13  
Oxybee : EPAR - Summary for the public SL = slovenščina 2018-03-13  
Oxybee : EPAR - Summary for the public FI = suomi 2018-03-13  
Oxybee : EPAR - Summary for the public SV = svenska 2018-03-13  
Oxybee : EPAR - Summary for the public HR = Hrvatski 2018-03-13  

This EPAR was last updated on 13/03/2018 .

Authorisation details

Product details

Product details for Oxybee
NameOxybee
Agency product numberEMEA/V/C/004296
Active substance

oxalic acid dehydrate

International non-proprietary name (INN) or common name

oxalic acid dehydrate

Species Bees
Anatomical therapeutic chemical veterinary (ATCvet) codes QP53AG03


Publication details

Publication details for Oxybee
Marketing-authorisation holder

Dany Bienenwohl GmbH

Revision0
Date of issue of marketing authorisation valid throughout the European Union01/02/2018

Contact address:

Dany Bienenwohl GmbH
Geyerspergerstrasse 27
80689 Munich
Germany

Product information

Product information

01/02/2018  Oxybee -EMEA/V/C/004296

Name Language First published Last updated
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  
Oxybee : EPAR - Product Information HR = Hrvatski 2018-03-13  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  
Oxybee : EPAR - All Authorised presentations HR = Hrvatski 2018-03-13  

Pharmacotherapeutic group

Ectoparaciticides, insecticides and repellents; Ectoparaciticide for topical use, incl. insecticides

Therapeutic indication

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

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Oxybee : EPAR - Public assessment report HR = Hrvatski 2018-03-13  
CVMP summary of positive opinion for Oxybee HR = Hrvatski 2017-09-08  

Authorised

This medicine is approved for use in the European Union