Apivar 500 mg bee-hive strips for honey bees

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Amitraz

Saatavilla:

Veto-Pharma SAS

ATC-koodi:

QP53AD01

INN (Kansainvälinen yleisnimi):

Amitraz

Annos:

500 milligram(s)

Lääkemuoto:

Bee-hive strip

Prescription tyyppi:

LR: Licensed Retailer as defined in national legislation

Terapeuttinen alue:

amitraz

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2017-09-26

Valmisteyhteenveto

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Apivar 500 mg amitraz bee-hive strips for honey bees (AT, BE, BG, CY,
CZ, DE, EL, FR, HU, LT,
RO, SK)
Apivar 500 mg bee-hive strips for honey bees (HR, IE, PL, SI, UK(NI))
Apivar
vet 500 mg bee-hive strips (SE, NO, FI)
Apivar (DK)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 15g strip contains:
ACTIVE SUBSTANCE:
Amitraz…………………………………….500 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Bee-hive strips.
Rectangular translucent homogeneous rigid strip with a V-shape cutting
at one end and a hole above.
Strips are attached by two with a pre-cut line.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Honey bees.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of varroosis due to
_Varroa destructor_
sensitive to amitraz in honey bees.
4.3
CONTRAINDICATIONS
Do not use in case of known resistance to amitraz.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
It is recommended not to use the product during the honey flow but
after the honey harvest. See
section “Amount to be administered and administration route”.
Do not cut the strips.
All colonies in the same apiary should be treated simultaneously to
avoid reinfestation.
Do not re-use the strips.
The safety and efficacy of the product has only been investigated in
hives with a single brood chamber
(dose of 2 strips per hive/brood chamber). Use in hives with more than
one brood chamber is not
recommended.
Inappropriate use of the product could result in an increased risk of
resistance development and could
ultimately result in ineffective therapy.
Bee colonies should be monitored routinely for the level of varroa
mite infestation, specifically before
the treatment and for a period thereafter.
The product should be used as part of an integrated varroa control
program and treatment rotation should
be applied.
Amitraz resistance has been reported in some populations of Varroa
mites.
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In case of use in regions with suspected amitraz resistance, it i