NOAH Compendium

Printed from NOAH Compendium (https://www.noahcompendium.co.uk). (c) Copyright NOAH Compendium 2024. All Rights Reserved.
Date: Sunday, April 21, 2024 12:00

Release 3.131
Cydectin 0.1% w/v Oral Solution for Sheep
 
Species: Sheep
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for sheep, Pharmaceuticals: Endectocides: For sheep
Active ingredient: Moxidectin
Product:CYDECTIN® 0.1% w/v Oral Solution for Sheep
Product index: CYDECTIN Oral Solution for Sheep
Sheep - meat: 14 days
Withdrawal notes: Sheep milk: 120 hours
Incorporating:
Presentation
A pale yellow solution containing 1 mg/ml moxidectin. Also contains the excipients benzyl alcohol, butylhydroxyltoluene and disodium edentate.
Uses
Moxidectin is a second generation macrocyclic lactone of the milbemycin family.
CYDECTIN 0.1% Oral Drench for Sheep is indicated for the treatment and prevention of infections caused by:
Mature (adult) and immature (L4) gastro-intestinal nematodes
Haemonchus contortus (including inhibited larvae)
Teladorsagia circumcincta (including inhibited larvae)
Ostertagia trifurcata
Trichostrongylus axei (including inhibited larvae)
Trichostrongylus colubriformis
Trichostrongylus vitrinus
Nematodirus battus
Nematodirus spathiger
Nematodirus filicollis (adults only)
Strongyloides papillosus (larval stages only)
Cooperia curticei (adults only)
Cooperia oncophora
Oesophagostomum columbianum
Oesophagostomum venulosum (adults only)
Chabertia ovina
Trichuris ovis (adults only)
Adult respiratory tract nematode
Dictyocaulus filaria
CYDECTIN 0.1% Oral Drench for Sheep has a persistent effect in preventing reinfection by Teladorsagia circumcincta and Haemonchus contortus for 5 weeks and Oesophagostomum columbianum for 4 weeks.
Clinical trials have shown that CYDECTIN 0.1% Oral Drench for Sheep is effective against certain benzimidazole resistant strains of Haemonchus contortus, Teladorsagia circumcincta, Trichostrongylus colubriformis and Cooperia curticei.
Dosage and administration
CYDECTIN should be given as a single oral drench of 1 ml/5 kg live bodyweight, equivalent to 200 μg moxidectin/kg live bodyweight using the CYDECTIN drench gun or any standard drenching equipment.
To ensure a correct dosage, bodyweight should be determined as accurately as possible; accuracy of the dosing 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. Do not mix with other products.
Contra-indications, warnings, etc
The effects of GABA agonists are increased by moxidectin.
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.
Withdrawal Period
Meat and offal: 14 days
Milk: 120 hours
Operator warnings
Avoid direct contact with skin and eyes.
Do not smoke, drink or eat when using the product.
Wear impermeable rubber gloves during use.
Wash hands after use.
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 4 days 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 oral formulation to sheep, treated animals should not have access to watercourses during the first 3 days after treatment.
Pharmaceutical precautions
Protect from light. Do not store above 25°C.
When the container is broached (opened) for the first time, using the in-use shelf-life which is specified on this package insert, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written in the space provided on the label and carton.
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements. Do not contaminate watercourses with the product. Dangerous to fish and aquatic life.
Shelf-life after first opening the immediate container: 6 months.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-VPS
Packaging quantities
1, 2.5 and 5.0 litre HDPE bottles with polypropylene (PP) screw cap closure. Not all pack sizes may be marketed.
Further information
Moxidectin is a member of the 3-ML anthelmintic class.
Moxidectin has been shown to be safe for use in pregnant, lactating and breeding animals.
CYDECTIN 0.1% Oral Drench for Sheep has a wide margin of safety and symptoms of overdose do not generally 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.
Dosing Guidelines
CYDECTIN 0.1% Oral Drench for Sheep gives optimal pasture protection against stomach worms Teladorsagia sp and Haemonchus sp, with an 8 week dosing interval–i.e. 5 week persistent activity, plus a 3 week interval from any re-infection to the presence of eggs in the dung.
Ewes
Treat at or around lambing to minimise the "spring rise", and pre-tupping, when rams should be treated also.
After treatment, CYDECTIN 0.1% Oral Drench for Sheep continues to kill stomach worms picked up by the ewe for 5 weeks, thus substantially reducing pasture contamination. This "vacuum-cleaning" effect greatly reduces the worm challenge to lambs grazing the same pasture.
Lambs
The first dose should be given at around 4-6 weeks of age, with a second dose, if required 8 weeks later. Additional treatment may be required where there is a Nematodirus challenge.
Nematodirus
Treat lambs when a challenge is expected. CYDECTIN 0.1% Oral Drench for Sheep effectively controls Nematodirus at the time of dosing, but as with other available wormers does not offer a persistent effect against Nematodirus.
Marketing Authorisation Number
Vm 42058/4024
Significant changes
GTIN
GTIN description:1 litre:
GTIN:05038190000406
GTIN description:2.5 litre:
GTIN:05038190000413
GTIN description:5 litre:
GTIN:05038190000420