Apitraz 500 mg Bee-hive Strips for Honey Bees

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Bee colonies should be monitored routinely for the level of varroa mite infestation
during treatment and also for a period thereafter.
The product should be used as part of an integrated varroa control program.
Inappropriate use of the product could result in an increased risk of resistance
development and could ultimately result in ineffective therapy.
Amitraz resistance has been reported in some populations of Varroa mites.
In countries with recognized amitraz resistance or in case of suspicion of amitraz
resistance, the use of the product should ideally be based on results of susceptibility
testing (e.g. Beltsville test). Please speak to your veterinarian or local bee inspector
for further information.
The safety and efficacy of the veterinary medicinal product has only been
investigated in hives with a single brood chamber (dose of 2 strips per hive/brood
chamber). No information is available on the safety and efficacy in hives with more
than one brood chamber.
In the presence of brood and depending upon the initial infestation level, an adequate
mite reduction above 95% is expected to occur at the end of the 10-weeks of
treatment.
4.5 Special precautions for use
i) Special precautions for use in animals
The safety profile for the product has not been established in weak colonies, i.e. those
colonies containing a number of bees that is lower than expected for the time of year.
Do not exceed or reduce the recommended dose and recommended duration of use.
Remove the strips at the end of treatment.
ii) Special precautions to be taken by the person administering the veterinary
medicinal product to animals
This veterinary medicinal product contains amitraz, which can lead to neurological
side-effects in humans.
Amitraz is a monoamine oxidase inhibitor (MAOI); therefore, people taking MAOI-
containing medication should take particular care.
Handle and open container with care to minimise the potential for inhalation.
This veterinary medicinal product may cause skin sensitisation, allergic reactions and
eye irritation.
Personal protective equipment consisting of impervious gloves and the usual
beekeeping protective clothing should be worn when handling the veterinary medicinal
product.
Avoid contact with skin. In case of contact, wash thoroughly with soap and water.

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Avoid contact with eyes. In case of contact, rinse with plenty of water immediately.
If irritation occurs, seek immediate medical advice and show the package leaflet or
label to the physician.
Do not eat, drink or smoke during its use.
Wash your hands thoroughly after use.
In case of accidental ingestion or inhalation, seek medical advice immediately and
show the the package leaflet or label to the physician.
Special precautions for the protection of the environment:
Do not throw strips or empty sachets in ponds or streams, as the product could be
dangerous for fish and aquatic organisms
iii) Other precautions
Not applicable
4.6 Adverse reactions (frequency and seriousness)
None known.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See also the last section of the
package leaflet for contact details.
4.7 Use during pregnancy, lactation or lay
Not applicable.
4.8 Interaction with other medicinal products and other forms of interaction
The toxicological effect of the amitraz is increased in the presence of copper salts and
the therapeutic activity decreases in the presence of piperonyl butoxide. Use of either
of these substances with the product should be avoided.
Do not use any other parasiticide product at the same time.
4.9 Amounts to be administered and administration route
In-hive use
Use two strips per hive (i.e. 1 g of amitraz per hive), and hang each strip between two
frames of honeycomb inside the brood area or the bee cluster with a minimum distance
of two frames between strips.

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Place the strips between frames where the bees exhibit the greatest mobility. Hang
the strips in such a way as to provide bees with free access to both sides, whilst
maintaining bee space.
Hive types:
•
third and the fourth honeycombs and the other between the seventh and eighth
honeycombs.
•
and sixth honeycombs and the other between the ninth and tenth honeycombs.
•
third and the fourth honeycombs and the other between the seventh and eighth
honeycombs.
In the absence of brood or when the amount of brood is at its lowest level, strips may
be removed after 6 weeks of treatment. In the presence of brood, strips must only be
removed after 10 weeks of treatment.
The strips should not be cut.
Strips should be repositioned, if necessary, in case of changes in the bee cluster or
brood area.
Precautions of use and application timetable:
The recommended time for treatment is when honey supers are not present after the
last honey harvest (late summer/autumn) and before spring honey-flow period.
Infestation monitoring is recommended to determine the best time for treatment.
Remove the strips before the honey flow starts.
Levels of brood and climatic conditions must be considered prior to product application.
The product should be applied when the bees are still active, i.e. before the bees form
a winter cluster, the exact timing of which can vary between climatic zones.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
One and half times the recommended dose, for a period of 8 weeks has been
administered and results in a slightly higher number of dead bees compared to the
recommended posology.
No overdose studies have been conducted when the product is applied for 10 weeks.
4.11 Withdrawal period(s)
Honey: zero days
Do not use during honey flow. Do not extract honey from the brood chamber.
Do not harvest honey during the 6-week or 10-week treatment period.

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Brood combs should be replaced with new foundation at least every three years. Do
not recycle brood frames as honey frames.
5.