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Date: Saturday, June 15, 2024 1:57

Release 3.195
Cydectin 10% LA Solution for Injection for Cattle
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For cattle, Pharmaceuticals: Endectocides: For cattle, Pharmaceuticals: Endoparasiticides: Anthelmintics for cattle
Active ingredient: Moxidectin
Product:CYDECTIN® 10% LA Solution for Injection for Cattle
Product index: CYDECTIN 10% LA Solution for Injection for Cattle
Cattle - meat: 108 days
Withdrawal notes: Not authorised for use in animals producing milk for human consumption. Do not use in pregnant animals which are intended to produce milk for human consumption within 80 days of expected parturition.
Incorporating:
Presentation
A clear yellow solution for injection containing 100 mg/ml moxidectin and 70 mg/ml benzyl alcohol.
Uses
In cattle weighing from 100 to 500 kg bodyweight, CYDECTIN 10% LA is indicated for the treatment and prevention of mixed infestations by the following gastro-intestinal nematodes, respiratory nematodes and certain arthropod parasites:
Adult and immature gastro-intestinal nematodes
Haemonchus placei
Haemonchus contortus
Ostertagia ostertagi (including inhibited larvae)
Trichostrongylus axei
Trichostrongylus colubriformis
Nematodirus helvetianus (adults only)
Nematodirus spathiger
Cooperia surnabada
Cooperia oncophora
Cooperia pectinata
Cooperia punctata
Oesophagostomum radiatum
Bunostomum phlebotomum (adults only)
Chabertia ovina (adults only)
Trichuris spp. (adults only)
Adult and immature respiratory tract nematode
Dictyocaulus viviparus
Warble grubs (migrating larvae)
Hypoderma bovis
Hypoderma lineatum
Lice
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
Bovicola bovis (aid in control)
Mange mites
Sarcoptes scabiei
Psoroptes ovis
Chorioptes bovis (aid in control)
CYDECTIN 10% LA has a persistent action and protects cattle for a certain duration against infection or re-infection with the following parasites for the period indicated:
Species
Protection period (days)
Dictyocaulus viviparus
120
Ostertagia ostertagi
120
Haemonchus placei
90
Oesophagostomum radiatum
150
Trichostrongylus axei
90
Linognathus vituli
133
The veterinary medicinal product is effective against Hypoderma larvae at the time of treatment but its persistent activity against Hypoderma has not been evaluated.
If the veterinary medicinal product is given before the end of the fly season complimentary treatment with a product effective against Hypoderma may be required.
Persistent efficacy periods have not been established for parasite species other than those included in the above list. Therefore re-infection of animals on pasture contaminated by parasites other than these remains possible before the end of the 90 day minimum persistency period demonstrated for specific species.
Dosage and administration
Dosage
0.5 ml/50 kg bodyweight, equivalent to 1.0 mg moxidectin/kg bodyweight, given by a single subcutaneous injection in the ear using an 18 gauge, 25-40 mm hypodermic needle. Determine cattle weight to ensure correct dose rate is used.
Administration
The 50 ml vial stoppers must not be broached more than 20 times. Shake vigorously before use.
To ensure administration of a correct dosage, bodyweight should be determined as accurately as possible; accuracy of the dosing should be checked.
The injection should be given subcutaneously in the loose tissues on the dorsal surface of the ear, just distal to the distal edge of the auricular cartilage. The dorsal (outer) surface of the ear should first be cleansed with antiseptic and allowed to briefly air dry. Palpate the edge of the auricular cartilage closest to the head, on the dorsal (hairy) surface of the ear. From this landmark, taking care to avoid blood vessels (artery, vein), the needle should be inserted subcutaneously starting at a point approximately 3 to 3.5 cm distal to this edge (away from the head) and directed towards the base of the ear and the needle advanced to the hub. At this point, gently aspirate the syringe to confirm that the needle is not in a blood vessel. Upon injection, the resulting depot should reside just distal to the edge of the auricular cartilage. Following administration, the needle is withdrawn from the skin as pressure is applied for several seconds with the thumb at the point of insertion.
Diagram: Ear injection procedureDescription: h-241The injection site is approximately 3.5 cm (1.5 inches) distal to the distal edge of the ear cartilage.Description: h-242Use one hand to grasp and steady the ear.
Inject subcutaneously using an 18 gauge x 1 inch needle.Description: h-243Inject contents. Depot should be just distal to the distal edge of the auricular cartilage.
Apply pressure at the point of insertion as the needle is withdrawn from the skin to help seal the opening.
Due to the long-lasting protection against Dictyocaulus viviparus and the stomach worms, Ostertagia ostertagi and Haemonchus placei, a single treatment with the formulation at turn-out helps control parasitic bronchitis (lungworm) and parasitic gastro-enteritis throughout the grazing season by reducing the build-up of infective larvae on pasture associated with these parasites. For best results the injection should be given to each calf of target weight to be grazed together immediately prior to being turned out to pasture. Animals should be set stocked throughout the grazing season or moved to a pasture which has not been grazed by other cattle earlier in the season.
Contra-indications, warnings, etc
Do not use in animals less than 100 kg bodyweight or greater than 500 kg.
Do not inject the veterinary medicinal product by the intravascular route. Intravascular injection may result in ataxia, paralysis, convulsions, collapse and death. To prevent any intravascular injection, carefully follow the administration procedure described in the “Dosage and administration” section above.
Not to be mixed with other veterinary medicinal products before administration.
In order to prevent abscesses, a strict aseptic technique is recommended. CYDECTIN 10% LA for Cattle has been formulated specifically for subcutaneous injection in the dorsal surface of the ear of cattle and must not be given by any other route of administration or to any other species.
To avoid possible secondary reactions by the death of Hypoderma larvae in the spine or the oesophagus of animals, it is recommended to administer a product effective against Hypoderma larvae after the end of fly activity and before the larvae reach their resting sites. Consult your veterinary surgeon on the correct timing of this treatment.
Cattle:
Rare
(1 to 10 animals / 10,000 animals treated):
Injection site swelling1,2
Depression
Ataxia
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
Injection site abscess2
1immediate or delayed, may further develop into injection site abscesses, frequency tends to be higher in heavier animals.
2generally disappears without treatment within 14 days after administration, may persist up to 5 weeks (<5% of cases) or longer (very rare occasions).
In case of hypersensitivity reactions, symptomatic treatment should be applied.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the package leaflet for respective contact details.
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;
- Under-dosing which may be due to underestimation of bodyweight, misadministration of the veterinary medicinal 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.
Withdrawal period
Meat and offal: 108 days.
Milk: Not authorised for use in animals producing milk for human consumption. Do not use in pregnant animals which are intended to produce milk for human consumption within 80 days of expected parturition.
The withdrawal period is based solely on a single injection at the ear site of injection. Avoid direct contact with skin and eyes.
Operator warnings
Avoid direct contact with skin and eyes.
Wash hands after use.
Do not smoke, drink or eat while handling the veterinary medicinal product.
Take care to avoid self-injection.
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 cattle with the veterinary medicinal product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period 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, field studies indicate no long-term effects. Nevertheless, in case of repeated treatments with moxidectin (as with veterinary medicinal 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 veterinary medicinal product should be used only according to the label instructions. Based on the excretion profile of moxidectin when administered as the injectable formulation, treated animals should not have access to watercourses during the 10 days after treatment.
Pharmaceutical precautions
Do not store above 25°C.
Keep the vial in the outer carton in order to protect from light.
Shelf-life after first opening the immediate packaging: 28 days.
Medicine should not be disposed of via wastewater or household waste. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. The veterinary medicinal product should not enter water courses as moxidectin may be dangerous for fish and other aquatic organisms.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-VPS
Packaging quantities
50 ml and 200 ml high density polyethylene containers. Not all pack sizes may be marketed.
Further information
Moxidectin is a member of the 3-ML anthelmintic class.
Reactions at the injection site have to be expected more frequently and severe depending on the injected volume.
Systemic signs of overdose are consistent with the mode of action of moxidectin. These signs are manifested as transient salivation, depression, drowsiness and ataxia 24 to 36 hours post-treatment. The systemic signs usually disappear within 36 to 72 hours without treatment. At doses >3 times the recommended dose divided on both ears, the systemic signs included recumbency, muscle tremor, ruminal tympany and dehydration which were resolved after treatment with fluids. The systemic signs can last for a few days to ten days. There is no specific antidote.
Can be used during pregnancy.
Immunity to nematodes depends on adequate exposure to infection. Although not normally the case, circumstances could occur in which anthelmintic control measures might increase the vulnerability of cattle to re-infection. Animals may be at risk towards the end of their first grazing season, particularly if the season is long, or in the following year if they move onto heavily contaminated pasture. In such instances, further control measures may be necessary.
The effects of GABA agonists are increased by moxidectin.
Marketing Authorisation Number
UK(GB) Vm 42058/5116.
UK(NI) Vm 42058/3016.
Significant changes
GTIN
GTIN description:50 ml:
GTIN:05038190000246
GTIN description:200 ml:
GTIN:05038190000253