Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
oxalic acid dihydrate
Dany Bienenwohl GmbH
QP53AG03
oxalic acid dehydrate
Bees
Ectoparasiticides for topical use, incl. insecticides
For the treatment of varroosis (Varroa destructor) of honey bees (Apis mellifera) in brood-free colonies.
Authorised
2018-02-01
19 B. PACKAGE LEAFLET 20 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: Dany Bienenwohl GmbH 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 Oxybee 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. 21 4. INDICATION(S) For the treatment of varroosis ( _Varroa destructor) _ of honey bees ( _Apis mellifera)_ in brood-free colonies. 5. CONTRAINDICATIONS 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 H Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Oxybee powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One BOTTLE OF 375 G SOLUTION contains: ACTIVE SUBSTANCE: Oxalic acid dihydrate 17.5 g (equivalent to 12.5 g of oxalic acid) EXCIPIENTS: For the full list of excipients, see section 6.1 One BOTTLE OF 750 G SOLUTION contains: ACTIVE SUBSTANCE: Oxalic acid dihydrate 35.0 g (equivalent to 25.0 g of oxalic acid) EXCIPIENTS: For the full list of excipients, see section 6.1 One SACHET OF 125 G POWDER contains: EXCIPIENTS: Sucrose 125 g For the full list of excipients, see section 6.1 1 ml of MIXED BEE-HIVE DISPERSION contains: ACTIVE SUBSTANCE: Oxalic acid dihydrate 39.4 mg (equivalent to 28.1 mg of oxalic acid) EXCIPIENTS: For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Powder and solution for bee-hive dispersion. Solution for bee-hive dispersion (bottle containing the active substance): Clear and colourless solution. Powder for bee-hive dispersion (sachet): White crystalline powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Honey bees ( _Apis mellifera) _ _ _ _ _ _ _ 3 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of varroosis ( _Varroa destructor) _ of honey bees ( _Apis mellifera)_ in brood-free colonies. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Oxybee must only be applied 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 veterinary medicinal product with another approved varroacide with a different mode of action to decrease the potential for Varroa mites to develop resistance. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Do not exceed the recommended dose and do not administer this veterinary medicinal product more than once. Repeated tre Aqra d-dokument sħiħ