Oxybee
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
13-03-2018
Summary of Product characteristics
(SPC)
13-03-2018
Public Assessment Report
(PAR)
13-03-2018
Active ingredient:
oxalic acid dihydrate
Available from:
Dany Bienenwohl GmbH
ATC code:
QP53AG03
INN (International Name):
oxalic acid dehydrate
Therapeutic group:
Bees
Therapeutic area:
Ectoparasiticides for topical use, incl. insecticides
Therapeutic indications:
For the treatment of varroosis (Varroa destructor) of honey bees (Apis mellifera) in brood-free colonies.
Authorization status:
Authorised
Authorization date:
2018-02-01
Patient Information leaflet
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
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Summary of Product characteristics
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
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