Description
Biowar 500 mg, strip for hanging inside a beehive
Statement of the active substance(s) and other ingredient(s)
Each strip contains:
Active substance: Amitraz 500 mg
Excipient: Polyethylene
White plastic strip with smooth surfaces.
Pack size
10 strips
Target species
Honeybee
Indications for use
Control of Varroa mites on bees.
Contraindications
None
Special warnings
Special warnings:
Treat all colonies in the apiary at the same time.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
When handling the strips, use protective gloves.
Do not eat, drink, smoke when handling the product.
Avoid contact with skin and eyes when using the strips.
Wash hands with warm water and soap after use.
Avoid contact with food.
Interaction with other medicinal products and other forms of interaction:
Amitraz toxicity increases in the presence of copper salts, and its efficacy deceases in the presence of piperonyl butoxide. Avoid using these substances simultaneously with amitraz.
Overdose:
No adverse effects have been observed after administration of a 5-fold higher doses than the recommended doses for the period of 6 weeks.
Major incompatibilities:
None known
Adverse events
None known.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. If you notice any side effects, even those not already listed in this package leaflet, or you think that the medicine has not worked, please contact, in the first instance, your veterinarian. You can also report any adverse events to the marketing authorization holder using the contact details found at the end of this leaflet, or via your national reporting system: Department for Documentation Assessment and Pharmacovigilance of Veterinary Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-02-222 Warsaw, Tel.: +48 22 49-21-687, Fax: +48 22 49-21-605, https://smz.ezdrowie.gov.pl
Dosage for each target species, route(s) and method(s) of administration
The product is to be suspended inside a beehive in a dose: 2 strips/1 hive.
Advice on correct administration
Place strips in aisles between frames where bee activity is the highest. Hang the strips so as to provide free bee access from both sides, which can be done by maintaining proper distance between the frames.
Leave the strips in a hive for 6 weeks, then remove. If bee activity inside the hive is away from the strips, change strip location to place them inside the bee colony, and before removing, leave the strips for another 2 weeks. The strips must be removed after the maximum of 8 weeks. Do not re-use the strips.
It is recommended to administer treatment in all hives at the same time.
Recommended period of treatment: after the last honey harvest (end of summer/autumn) and in spring before the first pollen harvest.
Observe the recommended treatment periods and doses.
Withdrawal period(s)
Honey – zero days.
Do not use during production of honey intended for human consumption.
Special storage precautions
Keep out of the sight and reach of children.
Store below 25℃.
Store in the original, tightly closed container.
Shelf life after first opening the immediate packaging: use immediately.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Special precautions for disposal of the veterinary medicinal product
Medicines should not be disposed of via wastewater or household waste.
This veterinary medicinal product should not enter water courses as amitraz is toxic for fish and other aquatic organisms.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any applicable national collection systems. These measures should help to protect the environment.
Ask your veterinary surgeon how to dispose of medicines no longer required.
Classification of veterinary medicinal products
Veterinary medicinal product subject to prescription
Marketing authorisation numbers and pack sizes
MA number: 2085/11
Pack size: 10 strips
Date on which the package leaflet was last revised
29/01/2025
Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).
Contact details
Marketing authorisation holder and manufacturer responsible for batch release:
Biowet Puławy Sp. z o.o.
Henryka Arciucha 2
24-100 Puławy
Poland
Tel./Fax: + 48 (81) 886 33 53, Tel.: + 48 (81) 888 91 00
e-mail: sekretariat@biowet.pl
Contact details to report suspected adverse events:
Biowet Puławy Sp. z o.o.
Henryka Arciucha 2
24-100 Puławy
Poland
Tel: + 48 (81) 888 91 33, + 48 509 750 444
e-mail: biowet@biowet.pl
SPC 2025-01-29
2025-03-21
