SUMMARY OF PRODUCTS
1. NAME OF THE VETERINARY
Calicide, Teflubenzuron 1000g/kg. Premix
for medicated feeding stuff.
2. QUALITATIVE AND QUANTITATIVE
Technical Teflubenzuron 1000 g/kg
For full list of excipients, see section
3. PHARMACEUTICAL FORM
Premix for medicated feeding stuff.
A white to off-white powder.
4. CLINICAL PARTICULARS
4.1 Target species
salmon (salmo salar)
4.2 Indications for use,
specifying the target species
therapeutic use in Atlantic salmon (Salmo
salar) for the control and treatment of
infestation by developing stages of the salmon louse
Do not use when fish are sick or
anorexic or where the appropriate amount of medicated feed is
unlikely to be consumed.
4.4 Special warnings for each
Ensure adequate medication of all fish
in the cage by good feeding practice but do not exceed the
4.5 Special precautions for
i. Special precautions for use
Do not administer before
completion of the withdrawal period of previous treatments.
The product has no residual
activity and is only effective during the treatment period.
The product is effective only
against the developing (moulting) stages of sealice. If adult lice
are present, use of an appropriate topical adulticide is
recommended prior to start of treatment.
For oral administration is fish
The product is not suitable for
Special precautions for the person administering
the veterinary medicinal product to animals
material: Use a scoop and wear impervious
gloves, overalls, approved safety glasses and a disposable
half-mask respirator conforming to European Standard EN 149 or a
non-disposable respirator to European Standard EN 140 with a filter
to EN 143, when handling this product.
fish feed: Never use bare hands to pick up
the medicated feed. Use a scoop, wear impervious gloves and
disposable half-mask respirator conforming to European Standard EN
149 or a non-disposable respirator to European Standard EN 140 with
a filter to EN 143 when administering the medicated
Do not smoke, eat or drink
whilst handling this product or handling medicated feed.
Wash hands after use of this
product or medicated feed.
This product is not authorised
for clinical use in water temperatures below 9ºC.
Before administering Calicide
the user must first apply for and obtain a consent for its
discharge from the Scottish Environment Protection Agency (SEPA) in
Scotland or the Environment Agency (EA) in England and Wales. The
appropriate agency must also be advised of the time of use and
subsequently of the quantities used.
Adverse reactions (frequency
4.7 Use during pregnancy,
lactation or lay
Use in broodstock has not been
4.8 Interaction with other
medicinal products and other forms of interaction
Use in conjunction with other
medications has not been investigated.
4.9 Amount(s) to be administered and administration
The product is effective
against developing (moulting) larvae and pre-adult stages of sea
lice. Therefore pre-treatment with suitable ectoparasiticide is
recommended to control adult sealice.
For incorporation into dry feed
at the registered mill.
The product is sold ready for mixing
with pelleted fish feed for oral administration. The product is
administered at a dose rate of 10 mg teflubenzuron per kilogram
body weight per day for 7 days. Mixing should be carried out in a
feed mill authorised to incorporate at levels below 2 kg per
A manufacturer who is approved
to incorporate directly at any concentration, veterinary medicinal
products or premixtures containing such products must be
responsible for mixing when incorporation is less than 2kg per
tonne for final feed.
It is important to ensure that
all the medicated feed is consumed by all the fish in the cage. The
required dose should be incorporated into 50-70% of daily feed
ration and given as the first feed of the day using good feeding
practice. Extra feeding requirements can be supplied using
The final pharmaceutical from
is prepared either by mixing the product with pelleted feed, which
is then sprayed with fish oil to ensure adherence of the
teflubenzuron, or by dispersing it in fish oil and then spraying it
onto the pelleted feed. The final pharmaceutical form administered
to fish is a dry pellet.
Before administering the product
the user must first apply for and obtain a consent for its
discharge from the Scottish Environmental Protection Agency (SEPA)
in Scotland or the Environment Agency (EA) in England and Wales.
The appropriate agency must also be advised of the times of use,
and subsequently of the quantities used.
Overdose (symptoms, emergency
procedures, antidotes), if necessary
Overdosing is unlikely to occur in
practice, and no special warnings are required, if the recommended
dosage is adhered to.
Target animal safety studies in
which doses of up to 4.7 times the recommended dose and over 3
times the recommended duration were administered, indicated no
adverse effects. Acute toxicity studies have shown that there are
some reversible behavioural effects seen at dose rate of between 12
times and 20 times the therapeutic dose.
Fish must not be slaughtered for human
consumption during treatment. Fish may only be slaughtered for
human consumption seven days after last treatment
5. PHARMACOLOGICAL PROPERTIES
insecticides and repellents.
ATC Vet Code:
Teflubenzuron is an insect growth
regulator belonging to the benzoyl urea group of compounds.
Teflubenzuron is active orally and interferes with chitin synthesis
and the moulting process of sea lice.
Pharmacokinetic and metabolic
studies have indicated that the oral bio availability of
approximately 9% , indicating incomplete absorption and low
systemic exposure. After a single oral dose,
Tmax is between 9 and 24 hours, and Cmax 150-572 ng/ml, being
temperature related. Steady state plasma concentrations after
multiple dosing are achieved by day 2.
low oral bioavailability, the absorbed material is rapidly
distributed to the tissues. Highest concentrations of teflubenzuron
are found in the gall bladder at 2 days and the liver at 9 hours.
These high levels and the relatively long half-life in the liver
(38 days) indicate enterohepatic recirculation, which is commonly
seen in fish. Elimination is biphasic. In repeat oral dose studies
at 10°C, the
half-lives over the initial 24 hour phase were calculated to be 2.6
days for the kidney and 3.8 days for the skin and muscle
List of excipients
Shelf life of the veterinary
medicinal product as packaged for sale: 5 years.
Shelf life after incorporation
into meal or pelleted feed: 6 months.
6.4 Special precautions for
25°C. Store in a
6.5 Nature and composition of
Polyethylene bag, in either a steel or
microfibre drum containing 25kg, or a polyethylene bag within
polyethylene pail containing 1kg, 2kg, 5kg or 10kg, closed with a
polyethylene push fit lid.
Not all pack sizes may be marketed.
6.6 Special precautions for the
disposal of unused veterinary medicinal product or waste materials
derived from the use of such products, if appropriate
Any unused product or waste
material should be disposed of in accordance with national
7 MARKETING AUTHORISATION
Trouw (UK) Limited
8. MARKETING AUTHORISATION
9. DATE OF FIRST
10. DATE OF REVISION OF THE