NOAH Compendium

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Date: Saturday, June 15, 2024 1:11

Release 3.188
Cydectin 0.5% w/v Pour-On for Cattle
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for cattle, Pharmaceuticals: Ectoparasiticides: For cattle, Pharmaceuticals: Endectocides: For cattle
Active ingredient: Moxidectin
Product:CYDECTIN® 0.5% Pour-On for Cattle
Product index: CYDECTIN 0.5% Pour-On for Cattle
Cattle - milk: 6 days (144 hours)
Cattle - meat: 14 days
Incorporating:
Presentation
A pale yellow oily solution containing 5 mg/ml moxidectin. Also contains 0.1 mg/ml butylated hydroxyanisole and 0.03 mg/ml tert butyl hydroquinone as antioxidants.
Uses
Moxidectin is a second generation macrocyclic lactone of the milbemycin family.
For the treatment of the following parasites sensitive to moxidectin:
Mature (adult) and immature (L4) gastrointestinal nematodes
Ostertagia ostertagi (including inhibited larvae)
Haemonchus placei
Trichostrongylus axei
Nematodirus helvetianus
Cooperia oncophora
Cooperia punctata (adults)
Oesophagostomum radiatum (adults)
Bunostomum phlebotomum (adults)
Adult respiratory tract nematode
Dictyocaulus viviparus
Warbles (migrating larvae)
Hypoderma bovis
Hypoderma lineatum
Lice
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
Bovicola (Damalinia) bovis
Mange Mites
Sarcoptes scabiei
Psoroptes ovis
Chorioptes bovis
Horn Flies
Haematobia irritans
CYDECTIN Pour-On has a persistent effect in preventing re-infection by Ostertagia ostertagi for 5 weeks and Dictyocaulus viviparus for 6 weeks after a single dose.
Dosage and administration
Dosage
1 ml per 10 kg bodyweight to give 0.5 mg moxidectin/kg bodyweight.
Administration
Apply along the midline of the back, from the withers to the tail head. Apply to clean, healthy areas of skin.
Contra-indications, warnings, etc
For external use on cattle only.
Not to be used in other species as severe adverse reactions, including fatalities in dogs, may occur.
To avoid possible secondary reactions due to the death of Hypoderma larvae in the spine or oesophagus, it is recommended to administer CYDECTIN Pour-On at the end of the period of warble fly activity, and before the larvae reach their resting sites. Consult your veterinary surgeon on the correct timing of treatment.
Reactions at the site of application may occur after application in very rare occasions. Neurological signs (including ataxia, trembling and lethargy have been reported in very rare cases (less than 1 animal in 10,000 animals treated, including isolated reports).
Withdrawal period
Meat and offal: 14 days.
Milk: 6 days (144 hours).
Operator warnings
Do not eat, drink or smoke whilst handling the product.
Wear protective clothes and gloves when applying the product.
Wash hands after use.
Avoid direct contact with human skin and eyes.
If splashed in the eye or on the skin, wash with plenty of clean, running water immediately.
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 cattle with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period more than 2 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, field studies 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 pour-on formulation, treated animals should not have access to watercourses during the first week after treatment.
Pharmaceutical precautions
Keep the container in the outer carton to protect from light.
Do not store above 25°C. If accidentally frozen, shake vigorously before use.
Not to be mixed with other veterinary medicinal products before application.
After first opening, use the product within 6 months.
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. The product can be toxic for fish and aquatic organisms.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-VPS
Packaging quantities
500 ml and 1 litre fluorinated high-density polyethylene squeeze-measure-pour bottles and 2.5 and 5 litre fluorinated high-density polyethylene backpacks. Not all pack sizes may be marketed.
Further information
Moxidectin is a member of the 3-ML anthelmintic class.
CYDECTIN Pour-On has a wide margin of safety and no symptoms of overdose have been observed at 10 times the recommended dose. They are manifested as transient salivation, depression, drowsiness and ataxia. There is no specific antidote.
CYDECTIN Pour-On has been shown to be safe for use in pregnant and lactating animals and breeding bulls.
Clinical trials have shown that efficacy is not affected by rainfall before or after treatment.
Dosing guidelines
Spring/Summer dosing
CYDECTIN Pour-On gives optimal pasture protection against stomach worm and lungworm with an 8–10 week dosing interval, depending on the level of pasture challenge, i.e. the length of persistent activity plus the interval from any re-infection to the presence of eggs/larvae in the dung. Ask your veterinary surgeon or animal health advisor for the appropriate timing of treatment in your area.
Late grazing/Housing dose
Treat at or within 5 weeks before housing to control internal and external parasites. The persistent activity against stomach worm and lungworm means that within 5 weeks of treatment:
cattle can be housed with no further dose needed at housing
housed cattle can be repeatedly turned back out to grass and stay protected.
The prolonged effect in preventing re-infection of Ostertagia spp. for 5 weeks and of Dictyocaulus spp. for 6 weeks provides the basis for the use of CYDECTIN Pour-On in strategic parasite control programmes.
Marketing Authorisation Number
Vm 42058/4025
Significant changes
GTIN
GTIN description:500 ml:
GTIN:05038190000307
GTIN description:1 litre:
GTIN:05038190000314
GTIN description:2.5 litre:
GTIN:05038190000321
GTIN description:5 litre:
GTIN:05038190000338