Negara: Portugal
Bahasa: Inggris
Sumber: HMA (Heads of Medicines Agencies)
amitraz 500 mg
Laboratorios Calier
QP53AD01
Bee-hive strip
amitraz
Bees
2013-10-04
B. LABEL - LEAFLET PACKAGE LABEL- LEAFLET 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Marketing authorisation holder: LABORATORIOS CALIER, S.A. Barcelonès, 26 – Pla del Ramassà Les Franqueses del Vallès (Barcelona) 2. NAME OF THE VETERINARY MEDICINAL PRODUCT APITRAZ 500 mg bee hive strips Amitraz 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) Each strip contains: ACTIVE SUBSTANCE: Amitraz .........................................500 mg PHARMACEUTICAL FORM Bee-hive strip 4. INDICATION Treatment of external parasitosis caused by _Varroa destructor_ sensitive to Amitraz. 5. CONTRAINDICATIONS None 6. ADVERSE REACTIONS If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Honey bees – _Apis mellifera_ 8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION In-hive use Hang two strips per hives, between 2 honeycombs. Hives types: Hives type Dadant (perfection), place one strip between the third and the fourth honeycombs and the other between the seventh and eighth honeycomb, it means outside the brood chamber. Hives type Layens, place one strip between the fifth and sixth honeycomb and the other between the ninth and tenth honeycomb. 9. ADVICE ON CORRECT ADMINISTRATION Strips must be removed after 6 weeks. The veterinary medicinal product should be used in seasons of low breeding in the hive (when the amount of bee brood present in low). The best efficacy is to be expected when the product is use in late Baca dokumen lengkapnya
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Apitraz 500 mg bee-hive strips. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each strip contains: ACTIVE SUBSTANCE: Amitraz ........................................ 500 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Bee-hive strip White rectangular strip 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Honey bees – _Apis mellifera_ 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of external parasitosis caused by _Varroa destructor _sensitive to Amitraz. 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES All colonies in the same apiary should be treated simultaneously to avoid robbery. Do not re-use the strips_. _An inappropriate use of antiparasitic drugs could result in an increase risk of resistance development and could ultimately result in ineffective therapy. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Not applicable. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Amitraz is a monoamine oxidase inhibitor (MAOI); therefore, people taking MAOI-contaning medication should take particular care. Personal protective equipment consisting of rubber gloves should be worn when handling the veterinary medicinal product. Do not eat, drink or smoke during its use. Wash your hands after its use. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Not known. 4.7 USE DURING PREGNANCY, LACTATION OR LAY Not applicable. 4.8 INTERACTI Baca dokumen lengkapnya