Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
oxalic acid dihydrate, formic acid
BeeVital GmbH
QP53AG30
oxalic acid dihydrate / formic acid
Bees
Ectoparasiticides for topical use, incl. insecticides
Treatment of varroosis (Varroa destructor) in honey bee colonies with and without brood
Revision: 3
Authorised
2017-02-02
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE _MULTI-DOSE CONTAINER (BOTTLE)_ 1. NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed 5 mg/ml + 44 mg/ml bee-hive dispersion for honey bees Formic acid/oxalic acid dihydrate 2. STATEMENT OF ACTIVE SUBSTANCES Each ml contains: ACTIVE SUBSTANCES: Formic acid 5 mg Oxalic acid dihydrate 44 mg 3. PHARMACEUTICAL FORM Bee-hive dispersion 4. PACKAGE SIZE 555 ml 5. TARGET SPECIES Honey bees ( _Apis mellifera_ ). 6. INDICATION(S) Treatment of varroosis ( _Varroa destructor_ ) in honey bee colonies with and without brood. 7. METHOD AND ROUTE(S) OF ADMINISTRATION In-hive use. Read the package leaflet before use. Shake well before use. 8. WITHDRAWAL PERIOD(S) Withdrawal period(s): Honey: Zero days. 9. SPECIAL WARNING(S), IF NECESSARY 19 During the application of the veterinary medicinal product, wear protective clothing, acid-resistant gloves and glasses. Read the package leaflet before use. 10. EXPIRY DATE EXP Shelf life after first opening container: 30 days. Once opened, use by .… 11. SPECIAL STORAGE CONDITIONS Do not store above 25 °C. Keep the bottle tightly closed. Keep the bottle in the outer carton in order to protect from light. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Disposal: read the package leaflet. 13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE For animal treatment only. 14. THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children. 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER BeeVital GmbH Wiesenbergstraße 19 A-5164 Seeham AUSTRIA 16. MARKETING AUTHORISATION NUMBER(S) EU/2/16/203/001 17. MANUFACTURER’S BATCH NUMBER Batch 20 PARTICULARS TO APPEAR ON THE OUTER PACKAGE _CARDBOARD BOX WITH 12 SINGLE-DOSE SACHETS_ 1. NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed 75 mg + 660 mg bee-hive dispersion for honey bees Formic acid/oxalic acid dihydrate 2. STATEMENT OF AC Lire le document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed 5 mg/ml + 44 mg/ml bee-hive dispersion for honey bees 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCES: Formic acid 5 mg Oxalic acid dihydrate 44 mg (equivalent to 31.42 mg oxalic acid anhydrous) EXCIPIENTS: Caramel colour (E150d) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Bee-hive dispersion. Slightly brown to dark brown aqueous dispersion. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Honey bees ( _Apis mellifera_ ). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of varroosis ( _Varroa destructor_ ) in honey bee colonies with and without brood. 4.3 CONTRAINDICATIONS Do not use during nectar flow. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES This veterinary medical product should only be used as part of an integrated Varroa control programme. Mite levels should be monitored regularly. Efficacy was only investigated in hives with low to moderate mite infestation rates. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Following treatment, worker bees with a protruding proboscis were found. This might be associated with insufficient access to drinking water. Ensure, therefore, that treated bees have sufficient access to drinking water. The long-term tolerance of the veterinary medicinal product has only been tested over 18 months, i.e. a negative impact of the product on queens or colony development after longer treatment periods cannot be excluded. It is advised to check regularly that the queen is present, but avoid disturbing the hives in the days following treatment. 3 All colonies placed at the same location should be treated at the same time to minimize the risk of re- infestation. Special precautions to be taken by the person administering the veterinary medicinal product to animals − This veterinary medicinal product is irritating to the skin and eyes. Avoid contact with the skin, eyes and mucous membranes. Per Lire le document complet