Cydectin 0.1% W/V Oral Solution For Sheep
Revised: October 2013
AN: 00755/2013
SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of the veterinary medicinal product
CYDECTIN 0.1 % W/V ORAL SOLUTION for sheep
2. Qualitative and quantitative composition
Each ml contains
Active substance
Moxidectin Solid 1.00 mg
Excipients
Benzyl Alcohol (E1519) 40.00 mg
Butylated Hydroxy Toluene 2.50 mg
Disodium Edetate 0.27 mg
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Oral solution
Pale yellow solution
4. Clinical particulars
4.1. Target species
Sheep
4.2. Indications for use, specifying the target species
Infections of sheep with parasites sensitive to moxidectin.
For the treatment and prevention of infections caused
by:
- Adult and immature gastro-intestinal nematodes
.Haemonchus contortus
(including inhibited larvae)
.Ostertagia
circumcincta (including
inhibited larvae)
.Ostertagia
trifurcata
.Trichostrongylus axei
(including inhibited larvae)
.Trichostrongylus
colubriformis
.Trichostrongylus
vitrinus
.Nematodirus
battus
.Nematodirus
spathiger
.Nematodirus filicolis
(adults only)
.Strongyloides
papillosus(larval stages
only)
.Cooperia curticei
(adults only)
.Cooperia
oncoaphora
.Oesophagostomum
columbianum
.Oesophagostomum
venulosym(adults only)
.Chabertia
ovina
.Trichuris
ovis(adults only)
- Adult respiratory tract nematode
.Dictyocaulus
filaria
The product has a persistent effect in preventing reinfection:
.for 5 weeks by
Ostertagia circumcincta
and Haemonchus
contortus
.for 4 weeks by
Oesophagostomum columbianum
Clinical trials, after experimental and natural infection, have
shown that the product is effective against certain benzimidazole
resistant strains of:
.Haemonchus
contortus
.Ostertagia
circumcincta
.Trichostrongylus
colubriformis
.Cooperia
curticei
4.3. Contraindications
None
4.4. Special warnings for each target species
Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:
-
Too frequent and repeated use of anthelmintics from the same class, over an extended period of time
-
Underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device (if any).
Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.
Resistance to macrocyclic lactones has been reported in Teladorsagia in sheep in a number of countries. In 2008, throughout Europe, moxidectin resistance is very rare; it has been reported in a single case involving a levamisole-, benzimidazole and ivermectin-resistant strain of Teladorsagia circumcincta. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of parasites, local history of treatments and recommendations on how to use the product under sustainable conditions to limit further selection for resistance to antiparasitic compounds. These precautions are especially important when moxidectin is being used to control resistant strains.
4.5. Special precautions for use
Special precautions for use in animals
None known.
Special precautions to be taken by the person administering the medicinal products to animals
Avoid direct
contact with skin and eyes.
Wash hands after use.
Do not smoke or eat when using this product.
Wear impermeable rubber gloves during use.
Other precautions
4.6. Adverse reactions (frequency and seriousness)
None known.
4.7. Use during pregnancy, lactation or lay
Moxidectin has been shown to be safe for use in pregnant, lactating and breeding animals.
4.8. Interaction with other medicinal products and other forms of interaction
The effects of GABA agonists are increased by moxidectin
4.9. Amount(s) to be administered and administration route
Should be given as a single oral drench of 1 ml/5 kg live bodyweight, equivalent to 200 µg moxidectin/kg live bodyweight, using any standard drenching equipment.
To ensure administration of a correct dosage, body weight should be determined as accurately as possible; accuracy of the dosing should be checked. Do not mix with other products.
4.10. Overdose (symptoms, emergency procedures, antidotes), if necessary
Symptoms generally do not occur at less than 5 times the
recommended dose.
They are manifested as transient salivation, depression, drowsiness
and ataxia 8 to 12 hours post-treatment. Treatment is not generally
necessary and recovery is generally complete within 24 to 48 hours.
There is no specific antidote.
4.11. Withdrawal period(s)
Meat and offal: 14 days.
Milk: 5 days.
5. Pharmacological properties
Pharmacotherapeutic group: Endectocides (milbemycins)
ATC Vet code: QP54AB02
5.1. Pharmacodynamic properties
Moxidectin is a parasiticide
active against a wide range of economically important internal and
external parasites and is a second generation macrocyclic lactone
of the milbemycin family. Its principal mode of action is
interfering with neuromuscular transmission of the GABA (gamma
amino butyric acid)-gated or glutamate-gated chloride channels.
Moxidectin stimulates the release of GABA and increases its binding
to the postsynaptic receptors. The net effect is to open the
chloride channels on the postsynaptic junction to allow the inflow
of chloride ions and induce an irreversible resting state. This
results in flaccid paralysis and eventual death of parasites
exposed to the drug
5.2. Pharmacokinetic particulars
22% of an
oral dose of moxidectin is absorbed with maximum blood
concentrations being achieved 9 hours post treatment. The drug is
distributed throughout the body tissues but due to its
lipophilicity the target tissue is fat where concentrations are 10
to 20 times higher than those found in other tissues. The depletion
half life in fat is 23-28 days.
Moxidectin undergoes limited biotransformation by hydroxylation.
The only significant route of excretion is the
faeces.
6. Pharmaceutical particulars
6.1. List of excipients
Benzyl Alcohol (E1519)
Butylated Hydroxy Toluene
Disodium Edetate
Polysorbate 80
Propylene glycol
Dibasic sodium phosphate dodecahydrate
Monobasic sodium phosphate dihydrate
Water for injections
Phosphoric acid as a pH buffer
Sodium hydroxide as a pH buffer
6.2. Incompatibilities
Not to be mixed with other Veterinary Medicinal Products before administration
6.3. Shelf-life
Shelf life of the veterinary
medicinal product as packaged for sale: 2 years
Shelf life after the first opening of the immediate packaging: 6
months
6.4. Special precautions for storage
Protect from
light.
Do not store above 25°C.
6.5. Nature and composition of immediate packaging
HDPE 1 litre jerrycan and 2.5 and 5.0 litre LDPE flexipacks
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
DANGEROUS to fish and aquatic
life.
Do not contaminate ponds, waterways or ditches with the product or
used containers.
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
Zoetis UK Limited
5th Floor, 6 St. Andrew Street
London
EC4A 3AE
8. Marketing authorisation number
Vm:42058/4024
9. Date of Renewal of Marketing Authorisation
Date:13 October 2010
10. Date of the Revision of the Text
Date: October 2013
09 December 2013
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