SUMMARY OF PRODUCT CHARACTERISTICS
SPC
1. NAME OF VETERINARY MEDICINAL PRODUCT
FUMIDIL® B Powder for syrup 20 mg/g
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
% w/w
Fumagillin (as bicyclohexylamine salt)
2.00
For a full list of excipients please see section 6.1
3. PHARMACEUTICAL FORM
Powder for syrup.
Beige granulous powder.
4. CLINICAL PARTICULARS
4.1
Target species
Bees.
4.2
Indications for use
For the prevention of Nosema in honey bees.
4.3
Contra-indications
Do not exceed 49°C (120°F) when mixing Fumidil B.
Fumidil® B must not be used during periods of honey flow.
4.4
Special warnings for each target species
None.
4.5
Special precautions for use, including special precautions to be taken by
the person administering the medicinal product to the animals,
i) Special precautions for use in animals
None.
ii) Special precautions to be taken by the person administering the medicinal product
to animals:
Avoid inhaling powder when mixing.
Wear a filtering half mask respirator EN149 type FHM2 and a single use disposable
gloves when preparing the treatment.
Wash hands and exposed skin before eating, drinking or smoking.
4.6
Adverse reactions (frequency and seriousness)
None known.
4.7
Use during pregnancy, lactation or lay
Not applicable.
4.8
Interaction with other medicinal products and other forms of interaction
None reported.
4.9
Amounts to be administered and administration route
Each colony to be treated should receive approximately 166 mg of fumagillin activity.
There are 2 pack sizes: 25 g and 475 g.
25 g pack
166 mg of fumagillin activity is equivalent to one-third of a 25 g vial. The amount to
be given to a colony is administered in a syrup containing 6.35 kg (14 lb) of sugar in 4
litres (7 pints) of water.
Precise measurement is not essential since a “rough third” of the 25 g vial is more
than adequate for the treatment of the average colony.
It is easier to dissolve the sugar in warm water. It is, however, important that
Fumidil® B is NOT subjected to a temperature higher than 49°C (120°F) during any
stage of the mixing operation.
1.
Heat 7 pints of water per colony to 38-49°C (100-120°F)
2.
Apportion one third of the 25 g vial for each colony to be treated and
dissolve in the heated water
3.
While the water is still hot, add 6.35 kg (14 lbs) of sugar per colony
and stir to make a clear syrup
4.
Feed this syrup to the bees in the usual way
475 g pack
This large pack contains 9.5 g fumagillin activity which makes sufficient syrup to treat
54 colonies. The contents of this pack should be dissolved in 216 litres (47½ gallons)
of water to which 343 kg (6¾ cwt) of sugar should be added as described above.
1.
Heat 216 litres (47½ gallons) of water to 38-49°C (100-120°F)
2.
Dissolve the whole contents of the pack in the heated water
3.
While the water is still hot, add 343 kg (6¾ cwt) of sugar and stir to
make a clear syrup
4.
Feed this syrup to the bees in the usual way
5.
Once this pack is opened, the contents must be used within 2 weeks
Fumidil® B is effective when fed in syrup in the autumn (September and October). It
can also be used in spring when the first few warm days occur.
Fumidil® B has no effect on the spores or the resting stage of Nosema apis and must
therefore be made available in the food of bees for three or four weeks to free the
colony population of infection. To prevent reinfection from spores carried by the
combs, the latter should be replaced by clean combs early in spring.
4.10
Overdose (Symptoms, emergency procedures, antidotes)
Not applicable.
4.11 Withdrawal periods for the various foodstuffs, including those for which
the withdrawal period is zero
Honey – Zero hours
5. PHARMACOLOGICAL PROPERTIES
Bicyclohexylamine fumagillin is the soluble salt of an antimicrobial produced by
Aspergillus fumigatus. This antimicrobial exhibits a specific action against the
protozoon organism, Nosema apis, the cause of nosema disease in honey bees. The
antimicrobial prevents the reproductive stages of the parasites attacking the epithelial
cells of the digestive stomach of the bee.
Fumidil B has no effect on the spores or resting stage of Nosema apis and must
therefore be made available in the food of bees for three to four weeks to free the
colony population of infection.
6. PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Polysorbate 80
Sodium phosphate (anhydrous)
Sodium acid phosphate (anhydrous)
6.2
Major incompatibilities
None Reported
6.3
Shelf-life
Shelf life of veterinary medicinal product as packaged for sale: 2 years
Shelf life after first opening the immediate packaging: 2 weeks
Shelf life after dilution or reconstitution according to directions: 24 hours
6.4
Special precautions for storage
Do not Store above 25°C (77°F).
Any medicated syrup which is not used within 24 hours should be discarded.
Once the pack is opened the contents should be used within 2 weeks.
Store in a dry place.
6.5
Nature and contents of container
(i)
A natural low density polyethylene bottle closed by a natural low density
polyethylene seal and cap (screw fit) containing 25 g of the product.
(ii)
A natural low density polyethylene bottle closed by a natural low density
polyethylene seal and cap (screw fit) containing 475 g of the product.
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused medicinal product or waste
materials if any
Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal products should be disposed of in accordance with local
requirements.
7. MARKETING AUTHORISATION HOLDER
CEVA Animal Health Ltd
90 The Broadway
Chesham
Buckinghamshire
HP5 1EG
8. MARKETING AUTHORISATION NUMBER
Vm 15052/4013
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
First authorised: 01/01/1989
Renewed: 01/01/1994
10. DATE OF REVISION OF THE TEXT
09th October 2007
11. FURTHER INFORMATION
None.