APITRAZ 500 mg
Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
05-10-2013
Summary of Product characteristics
(SPC)
05-10-2013
Active ingredient:
amitraz 500 mg
Available from:
Laboratorios Calier
ATC code:
QP53AD01
Pharmaceutical form:
Bee-hive strip
Therapeutic group:
amitraz
Therapeutic area:
Bees
Authorization date:
2013-10-04
Patient Information leaflet
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
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Summary of Product characteristics
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
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