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Cydectin 2% LA Sheep Injection for sheep treats and controls internal parasites such as gastro-intestinal round worms and lungworm and prevents and treats external parasite psoroptic manage (scab). Persistent action, of Cydectin 2% LA Sheep Injection, against scab mites for 60 days prevents infection or reinfection. The persistency of Cydectin 2% LA Sheep Injection exceeds mite survival in the environment. Cydectin 2% LA Sheep Injection offers up to 111 days worm protection in Sheep from a single injection.
Active Ingredient:
Moxidectin
Target Species:
Sheep
Treats and Controls:
Gastro-intestinal roundworm, lungworm, mange, scab, mites
Administration Method:
To be administered as a single subcutaneous injection at the base of the ear using an 18 gauge, 25mm hypodermic needle. The skin at the base of the selected ear should be pinched and the product injected into the subcutaneous tissue.
Withdrawal Time:
meat & offal: 104 days;
not permitted for use in Dairy Sheep
Dosage:
0.5 ml per 10 kg of bodyweight.
Body Weight | Dose Volume | Number of full doses per pack: | ||
50 ml | 200 ml | 500 ml | ||
10kg | 0.5ml | 100 | 400 | 1000 |
20kg | 1 ml | 50 | 200 | 500 |
30kg | 1.5 ml | 33 | 133 | 333 |
40kg | 2 ml | 25 | 100 | 250 |
50kg | 2.5 ml | 50 | 80 | 200 |
60kg | 3 ml | 16 | 66 | 166 |
70kg | 3.5 ml | 14 | 57 | 142 |
Always read the label and all enclosed information for Cydectin 2% LA injection before administering to animals!
Key Features of Cydectin 2% LA injection
Benefits of Long Worm Protection
Cydectin 2% LA Injection is extra-ordinary offering up to 111 days worm protection from a single injection. The Long Acting Injection will:
Reduce Pasture Contamination: The use of Cydectin LA Injection for Sheep will lead to lower pature contamination resulting in lower worm egg counts in lambs
Reduce Number of Flock Treatments: Ewes treated with Cydectin LA injection will result in low egg counts in lambs and may reduce the need of treatment. Less treatment will lower work-load, save money and reduce stress on lambs hence lowering the overall cost of interventions.
Maximise Lamb Growth Rate: Lambs coming from ewes treated with Cydectin LA Injection for Sheep have exhibited increased growth rates of 1.7kg/lamb in a 60-day period from shearing to weaning.
What Are the Dangers of Sheep Scab?
Sheep scab can occur at any time of the year, but when sheep are housed for the winter because they are in such close proximity to each other it can take only one female mite to infect an entire flock of sheep. This can have some very costly negative effects on your flock which can include, poor growth, reduced reproductive performances and even in severe cases it can cause death. Cydectin 2% will treat sheep scab and stop it from spreading throughout your flock, which will not only protect your flock but will also protect your profits.
What else can I do to stop the spread of disease and parasites in housed animals?
Although it may seem a little costly, improving the ventilation of housing greatly reduces the risk of respiratory disease throughout the livestock. Good hygiene throughout your housing will help reduce the spread of contagious conditions. This should include the the upkeep of bedding, feed areas and passageways.There should be effective slurry removal and bedding should be changed regularly.
Even though all these steps will help stop the spread of disease and parasites the most effective method is prevention and for that we recommend you use Cydectin 2% LA solution for injection.
Click here to Download Data Sheet
Health Products Regulatory Authority
Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cydectin 20 mg/ml LA Solution for Injection for Sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Moxidectin 20 mg
Excipients
Benzyl alcohol (E1519) 70 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear yellow liquid.
4 CLINICAL PARTICULARS
4.1 Target Species
Sheep above 15 kg bodyweight.
4.2 Indications for use, specifying the target species
Treatment and prevention of mixed infections of gastro-intestinal nematodes, respiratory nematodes and certain arthropod parasites in sheep.
Moxidectin is indicated for treatment of infections caused by moxidectin sensitive strains of:
Gastro-intestinal nematodes:
Haemonchus contortus (adults and L3)
Ostertagia (Teladorsagia) circumcincta (adults and L3, including inhibited larvae)
Trichostrongylus axei (adults)
Trichostrongylus colubriformis (adults and L3)
Nematodirus spathiger (adults)
Cooperia curticei (macmasteri) (adults)
Cooperia punctata (adults)
Oesophagostomum columbianum (L3)
Chabertia ovina (adults)
Respiratory tract nematodes
Dictyocaulus filaria (adults)
Larvae of Diptera
Oestrus ovis: L1, L2, L3
Mange mites
Psoroptes ovis
Trials have shown that moxidectin is effective against certain strains of Haemonchus contortus, Teladorsagia circumcincta and Trichostrongylus spp. resistant to benzimidazoles.
The product has a persistent action and protects sheep against infection or re-infection with the following parasites for the period indicated:
Species Days
Ostertagia (Teladorsagia) circumcincta 97
Haemonchus contortus 111
Trichostrongylus colubriformis 44
Psoroptes ovis 60
Persistent efficacy periods have not been established for parasite species other than those included in the list above. Therefore, re-infection of animals on pasture contaminated by parasites other than these remains possible before the 44 day minimum persistency period demonstrated for specific species.
4.3 Contraindications
Do not use in sheep less than 15 kg bodyweight. Do not inject the product by intravascular route. Intravascular injection may result in ataxia, paralysis, convulsions, collapse and death. See item "Special precautions for use in animals". Do not use in cases of hypersensitivity to the active substance or to any excipients.
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 moxidectin should be based on local (regional, farm) epidemiological information about susceptibility of nematodes, local history of treatments and recommendations on how to use the product under sustainable conditions to limit further selection for resistance to anthelmintics.
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
This product has been formulated specifically for subcutaneous injection in the base of the ear of sheep and must not be given by any other route of administration or to any other species.
Special precautions to be taken by the person administering the veterinary medicinal product to animals Avoid direct contact with skin and eyes.
Wash hands after use.
Do not smoke, drink or eat while handling the product.
Take care to avoid self-injection.
If this occurs, it is unlikely that any product related symptoms will be observed.
In case of accidental self injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Advice to Medical Practitioners in case of accidental self injection:
Treat symptomatically.
Other precautions regarding impact on the environment
Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance; therefore, exposure of the environment to moxidectin must be limited to the extent possible.
Treatments should be administered only when necessary and should be based on faecal egg counts or evaluation of the risk of infestation at the animal and/or herd level.
Like other macrocyclic lactones, moxidectin has the potential to adversely affect non-target organisms:
Faeces containing moxidectin excreted onto pasture by treated animals may temporarily reduce the abundance of dung feeding organisms.
Following treatment of sheep with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period of more than 4 weeks and may decrease dung fly abundance during that period.
It has been established in laboratory tests that moxidectin may temporarily affect dung beetle reproduction; however, studies with incurred residues indicate no long-term effects.
Nevertheless, in case of repeated treatments with moxidectin (as with products of the same anthelmintic class) it is advisable not to treat animals every time on the same pasture to allow dung fauna populations to recover.
Moxidectin is inherently toxic to aquatic organisms including fish.
The product should be used only according to the label instructions.
Based on the excretion profile of moxidectin when administered as the injectable formulation to sheep, treated animals should not have access to watercourses during the first 11 days after treatment.
4.6 Adverse reactions (frequency and seriousness)
Swelling and inflammation may be found at the injection site in some animals.
The swelling generally disappears within 7 days of treatment and generally resolves without any medical treatment. In rare cases, adverse reactions such as transitory salivation, depression, drowsiness and ataxia might occur.
No particular treatment is required; these symptoms usually disappear within 24 to 48 hours.
There is no specific antidote.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reaction(s))
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy.
However, note 4.3. Contraindications.
4.8 Interaction with other medicinal products and other forms of interactions
The effects of GABA agonists are increased by moxidectin.
4.9 Amounts to be administered and administration route
Dosage is 0.5 ml/10 kg bodyweight to give 1 mg moxidectin/ kg bodyweight.
The 50 ml vial stoppers must not be broached more than 10 times.
Use automatic syringe equipment for the 200 ml and 500 ml vials.
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.
If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- or overdosing.
The injection should be administered as a single subcutaneous injection at the base of the ear using an 18 gauge, 25 mm hypodermic needle.
With the animal's head under control, the formulation should be administered about 2 cm caudal from the anterior (rostral) edge of the pinna at the base of the ear. The skin at the base of the selected ear should be pinched and the product injected into the subcutaneous tissue.
Following subcutaneous administration, the needle should be withdrawn from the skin as pressure is applied with the thumb at the point of insertion for several seconds.
If leakage occurs then pressure should be applied for several additional seconds.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Signs of overdoses have not been seen at 3 and 5 times the recommended dose.
However, if they do occur they should be consistent with the mode of action of moxidectin and would be manifested as transient salivation, depression, drowsiness and ataxia 24 to 36 hours post-treatment.
The signs would usually disappear within 36 to 72 hours without treatment.
There is no specific antidote.
4.11 Withdrawal period(s)
Meat and offal: 104 days.
Milk: Not permitted for use in dairy sheep, at any stage of life.
The withdrawal period is based solely on a single injection at the base of the ear.
5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group:
antiparasitic product, endectocide
ATCvet Code
QP 54 AB 02, moxidectin
5.1 Pharmacodynamic properties
Moxidectin is an endectocide active against a wide range of internal and external parasites and is a second generation macrocyclic lactone of the milbemycin family.
Moxidectin interacts with GABA receptors and chloride channels.
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.
The product has a persistent activity against the second instar larvae of Oestrus Ovis (L2 Larvae only) up to 80 days after treatment.
However, re-infestation with 1st instar larvae is not prevented and clinical signs arising from such re-infestation may be observed during this period.
5.2 Pharmacokinetic particulars
Moxidectin is absorbed following subcutaneous injection with maximum blood concentrations (Cmax 24 ng/ml) being achieved 4 to 7 days post injection.
Mean AUC last is 411 ng.d/ml.
The drug is distributed throughout the body tissues but due to its lipophilicity it is concentrated mainly in the fat.
The depletion half life in fat is 30 - 34 days. Moxidectin undergoes biotransformation by hydroxylation in the body. The only significant route of excretion is the faeces.
5.3 Environmental properties
Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance.
In particular, in acute and chronic toxicity studies with algae, crustaceans and fish, moxidectin showed toxicity to these organisms, yielding the following endpoints:
Organism | EC50 | NOEC | |
---|---|---|---|
Algae | S. capricornutum | >86.9 μg/l | 86.9 μg/l |
Crustaceans (Water Fleas) | Daphnia magna (acute) | 0.0302 μg/l | 0.011 μg/l |
Daphnia magna (reproduction) | 0.0031 μg/l | 0.010 μg/l | |
Fish | O. mykiss | 0.160 μg/l | Not determined |
L. macrochirus | 0.620 μg/l | 0.52 μg/l | |
P. promelas (early life stages) | Not applicable | 0.0032 μg/l | |
Cyprinus carpio | 0.11 μg/l | Not determined | |
EC50: the concentration which results in 50% of the test species individuals being adversely affected, i.e. both mortality and sub-lethal effects.
NOEC: the concentration in the study at which no effects are observed.
This implies that when allowing moxidectin to enter water bodies, this may have a severe and lasting impact on aquatic life.
To mitigate this risk, all precautions for use and disposal must be adhered to.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzyl Alcohol (E1519)
Sorbitan Oleate
Propylene glycol dicaprylocaprate
6.2 Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.
6.4 Special precautions for storage
Do not store above 25°C.
Keep the container in the outer carton in order to protect from light.
6.5 Nature and composition of immediate packaging
Natural high density polyethylene vials with Flurotec coated chlorinated butyl rubber stoppers and aluminium flip off seals (50 ml) or aluminium seals (200 ml, 500ml).
Each vial is supplied in a carton.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Do not contaminate watercourses with the product.
Extremely dangerous for fish and aquatic organisms.
7 MARKETING AUTHORISATION HOLDER
Zoetis Belgium S.A.
2nd Floor,
Building 10
Cherrywood Business Park,
Loughlinstown
Co Dublin
Ireland
8 MARKETING AUTHORISATION NUMBER(S)
VPA10387/095/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 24 May 2019
10 DATE OF REVISION OF THE TEXT
May 2019
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