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CYDECTIN 2% w/v LA Solution for Injection for Sheep

Description

Cydectin 2% w/v LA is a clear yellow liquid solution for injection for sheep containing per ml:

Active ingredient:
Moxidectin 20 mg
Excipients:
Benzyl alcohol 70 mg

Indications

For treatment and prevention of mixed infections of gastro-intestinal nematodes, respiratory nematodes and certain anthropod parasites in sheep.
Moxidectin is indicated for treatment of infections caused by moxidectin sensitive strains of:

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 Protection period (days)
· 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.

CONTRAINDICATIONS

Do not use in dairy sheep, at any stage of life.
Do not use in sheep less than 15 kg bodyweight.
Do not use in cases of hypersensitivity to the active substance or to any excipients.

ADVERSE REACTIONS

Swelling and inflammation may be found at the injection site in some animals following treatment. The swelling generally disappears within 7 days of treatment and generally resolves without any medical treatment required.
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.

TARGET SPECIES

Sheep above 15kg bodyweight.

DOSAGE, ROUTE AND METHOD OF ADMINISTRATION

Dosage is 0.5ml/10 kg bodyweight to give 1 mg moxidectin/ kg bodyweight. The 50ml vial stoppers must not be broached more than 10 times. Use automatic syringe equipment for the 200 ml and 500ml 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 – 40 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.

Diagram: Ear injection procedure

ADVICE ON CORRECT ADMINISTRATION

None.

WITHDRAWAL PERIOD

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.

SHELF LIFE

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 28 days.

SPECIAL STORAGE PRECAUTIONS

Do not store above 25°C.
Keep the container in the outer carton to protect from light.

SPECIAL WARNINGS

CYDECTIN 2% LA for Sheep 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.
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. Advice to Medical Practitioners in case of accidental self injection: Treat symptomatically.
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.
Extremely dangerous for fish and aquatic organisms. Do not contaminate ponds, waterways or ditches with the product or empty container. Any unused product or waste material should be disposed of in accordance with local requirements.

OTHER INFORMATION

ATCvet Code QP 54 AB 02, moxidectin
Nature and composition of immediate packaging
Nature of the primary container:
HDPE vial
Chlorinated butyl rubber stopper
Aluminium flip-off seal (50 ml)
Aluminium seal (200 ml and 500ml)
Packaging
Box containing 1 vial of 50ml size (60 ml vial filled to 50ml)
Box containing 1 vial of 200ml size
Box containing 1 vial of 500ml size

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