DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Fadwa Almanakly, Pharm.D. Associate Director, Advertising and Promotions Bayer HealthCare Pharmaceuticals Inc. 6 West Belt Wayne, NJ 07470-6806 RE: NDA 21-225 Mirena® (levonorgestrel-releasing intrauterine system) MACMIS # 18166 The Division of Drug Marketing, A
- A |
J |K |
U |V |
Faq 25 otc treatments fvOTC Treatments of colonies with EFB Please read and retain for future reference
This sheet deals with actions relating to colonies treated with
oxytetracycline (OTC) following diagnosis of European Foul Brood
(EFB) by an appointed bee inspector.
The reason for change.
In 1967 OTC treatment for EFB infected colonies was introduced into the U.K. The
application method was in solution with sugar syrup. A standstill period was placed on the
treated apiary to allow for anti-biotic residues in honey to break down, before extraction
and either personal consumption or sale. The standstill was lifted after a clear foul brood
inspection by the appointed bee inspector at least eight weeks after treatment. Since that
time analytical methods used to detect residues in food have greatly improved and recent
studies by the Central Science Laboratory’s National Bee Unit (NBU) have established that
OTC residues remain at significant levels in honey substantially beyond an eight-week
In light of these studies, and so as to maintain the integrity of OTC in both animal and
human medicine DEFRA has agreed with the NBU that procedural changes must be made
relating to OTC treated colonies.
Alternatives to OTC treatment.
The NBU is currently running a trial relating to ‘shook swarm’ treatment techniques, which
do not use OTC or other anti-biotic. Destruction of infected colonies may also be an option.
Your Bee Inspector can advise you on the suitability of these alternatives.
What happens now?
On suspecting EFB in an apiary the ABI places a standstill on the apiary. This means that
you cannot remove any bees, equipment or crop away from the apiary without a
movement licence. It will remain in force until such time as it lifted by a Bee Inspector.
Standstill orders usually remain in force for a minimum of six weeks.
National Bee Unit Food and Environment Research Agency Sand Hutton, York. YO41 1 LZ Telephone 01 904 462 510 e mail [email protected] NBU Web Site: www.nationalbeeunit.com January 2010 Crown copyright. This sheet, excluding the logo, may be reproduced free of charge provide that it is reproduced accurately and not used in a misleading way. The material must be acknowledged. If you choose OTC treatment;
The bee inspector will apply the OTC to the colony, which as it is issued on veterinary
prescription will not be carried out at the time of discovery. The beekeeper is required to
note the date and other details of the treatment in their bee medicine register. The Bee
Inspector will return to re-examine the bees after a minimum of six weeks or the
commencement of the following season. If there is no suspicion of an EFB infection the
standstill will be lifted. If EFB is confirmed again the standstill remains in force.
Can I remove the honey crop?
A licence may be made available to harvest honey on colonies in infected apiaries prior to
OTC treatment. Conditions will apply to which the beekeeper must adhere. These include
returning supers and combs to the colony from which they came.
Will this apply to uninfected colonies?
What happens after treatment?
Supers can be removed and harvested subject to a movement licence being issued.
Honey extracted from colonies that have been treated with OTC must be packaged,
labelled and stored for a period of least six calendar months from the date of treatment.
This is the beekeepers responsibility. The extraction equipment must be thoroughly
cleansed after use extracting honey from treated colonies. Supers and combs must be
returned to the hive from which they were taken.
What happens if the standstill order is lifted?
Supers can be removed and extracted without the need for a licence. However honey
extracted from colonies that have been treated with OTC must be packaged, labelled and
stored for a period of least six calendar months from the date of treatment. This is the
beekeepers responsibility. The extraction equipment must be thoroughly cleaned after
use extracting honey from treated colonies. Supers and combs should be returned to the
hive from which they were taken.
It is the beekeepers responsibility to ensure that no honey from OTC
treated colonies enters the food chain for a period of at least six
Record of treatment. This must also be recorded in your bee medicament register.
National Bee Unit Food and Environment Research Agency Sand Hutton, York. YO41 1 LZ Telephone 01 904 462 510 e mail [email protected] NBU Web Site: www.nationalbeeunit.com January 2010
PATIENT INFORMATION ON AZATHIOPRINE (Brand names: Azahexal, Azapin, Imuran, Thioprine) This information sheet has been produced by the What benefit can you expect from Australian Rheumatology Association to help your treatment? you understand the medicine that has been prescribed for you. It includes important Azathioprine is usually used to treat severe rheumatoid arth