Cydectin 1% solution for injection for cattle 50 ml
Treatment and control of infections caused by moxidectin (Gastro-intestinal nematodes, Respiratory tract nematode, Warble grubs, Lice and Mange mites on cattles
CYDECTIN 1% w/v Solution for Injection for cattle
2. CYDECTIN QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Moxidectin: 10 mg
Benzyl Alcohol 40.00 mg
Butylated Hydroxytoluene 2.5 mg
Disodium edetate E 385 0.27 mg
For a full list of excipients, see section 6.1.
3. CYDECTIN PHARMACEUTICAL FORM
Solution for injection
Yellow to pale yellow solution, free from suspended matter.
4. CYDECTIN CLINICAL PARTICULARS
4.1 Target species
4.2 Indications for use, specifying the target species
Moxidectin is an endectocide with activity against a wide range of internal and external parasites of cattle.
Moxidectin is indicated for treatment and prevention of infections caused by:
- 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
. Linognathus vituli
. Haematopinus eurysternus
. Solenopotes capillatus
. Aid in the control of Damalinia bovis
- Mange mites
. Sarcoptes scabiei
. Psoroptes ovis
. Aid in the control of Chorioptes bovis
Moxidectin has a persistent effect against Ostertagia for 5 weeks and against Dictyocaulus for 6 weeks.
Do not use in lactating animals producing milk for human consumption or industrial purposes or within 60 days before parturition.
Do not use in horses.
Do not use in dogs
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;
Under-dosing which may 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.”
4.5 Special precautions for use
Special precautions for use in animals
Because of the particular susceptibility, it is not recommended to treat calves of less than 8 weeks. To avoid possible incidence of secondary reactions by the death of Hypoderma larvae in the spine or the oesophagus of animals, it is recommended to administer Cydectin 1% injectable after the end of fly activity and before the larvae reach their resting sites. The veterinary surgeon should give advice on the correct timing of treatment.
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.
Advice to Medical Practictioners in case of accidental self injection: Treat any specific signs symptomatically.
4.6 Adverse reactions (frequency and seriousness)
Drowsiness, depression, lethargy, apathy and weakness can be observed after treatment.
In case of hypersensitivity reactions, a symptomatic treatment is required.
4.7 Use during pregnancy, lactation or lay
Moxidectin has been shown to be safe for use in pregnant and lactating animals and breeding bulls. However note 4.3. Contra-Indications.
4.8 Interaction with other medicinal products and other forms of interaction
The effects of GABA agonists are increased by moxidectin.
4.9 Amounts to be administered and administration route
1 ml/50 kg live bodyweight, equivalent to 0.2 mg moxidectin/kg live bodyweight given subcutaneously in front of or behind the shoulder using a 16-18 gauge (1.5 - 1.2 mm) 1/2 inch. (1.5 cm) needle.
The use of a multidose equipment with a draw off needle is recommended for 200 ml and 500 ml packaging.
To ensure administration of a correct dosage, body weight should be determined as accurately as possible; accuracy of the dosing should be checked.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Symptoms of overdoses are consistent with the mode of action of moxidectin and generally do not occur at less than 3 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.
4.11 Withdrawal periods
Meat and offal: 65 days.
Milk: Not permitted for use in cattle producing milk for human consumption or industrial purposes or within 60 days before parturition.
5. CYDECTIN PHARMACOLOGICAL PROPERTIES
Moxidectin, ATC vet code: QP 54 AB 02
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 stimulates the release of GABA and increases its binding to the postsynaptic receptors. 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 result in flaccid paralysis and eventual death of parasites exposed to the drug.
There is no evidence that moxidectin has any other pharmacological effect on any mammalian organ or tissue. The only toxic effects seen in toxicology or use animal safety tests are entirely consistent with its neuromuscular transmission mode of action.
5.2 Pharmacokinetic particulars
Moxidectin is rapidly and completely absorbed following subcutaneous injection with maximum blood concentrations being achieved 8-12 hours post injection. The drug is distributed throughout the body tissues but due to its lipophilicity the target tissue is fat where concentrations are 10 - 20 times those of in other tissues. The depletion half life in fat is 23-28 days.
Moxidectin undergoes limited biotransformation by hydroxylation in the body. The only significant route of excretion is the faeces.
6. CYDECTIN PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Disodium edetate E 385
Sodium phosphate dibasic
Sodium phosphate monobasic
Phosphoric acid and/or Sodium hydroxide
Water for injection
Not to be mixed with other Veterinary Medicinal Products before administration.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 36 months
Shelf life of the veterinary medicinal product after the opening the immediate packaging: 6 months.
6.4. Special precautions for storage
Do not store above 25 °C. Protect from light.
6.5 Nature and composition of immediate packaging
Polyethylene containers of 50, 200 and 500 ml content sealed with bromobutyl stoppers.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
The product can be toxic for fish and other aquatic organisms. Do not contaminate ponds or other surface waters with the product or used containers.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
5th Floor, 6 St. Andrew Street