Cydectin 0.5% W/V Pour-On For Cattle
Revised: October 2013
AN: 00757/2013
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
CYDECTIN* 0.5% w/v Pour-On for cattle
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substances:
Moxidectin 5.00 mg
Excipients:
Butylated hydroxyanisole E320 0.10 mg
Tert butyl hydroquinone 0.03 mg
q.s. to 1. ml
For full list of excipients, see 6.1.
PHARMACEUTICAL FORM
Pour-on solution.
Pale yellow oily solution.
CLINICAL PARTICULARS
Target Species
Cattle
Indications for use specifying the target species
Infections of cattle with parasites sensitive to moxidectin.
For the treatment of infections caused by:
- Adult and larval gastro-intestinal nematodes:
Haemonchus placei
Ostertagia ostertagi (including inhibited larvae)
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 bovis (Damalinia bovis)
- Mange Mites
Sarcoptes scabiei
Psoroptes ovis
Chorioptes bovis
Horn Flies
Haematobia irritans
CYDECTIN 0.5% W/V POUR-ON for cattle has a persistent effect in preventing against reinfection by:
Ostertagia ostertagi for 5 weeks
Dictyocaulus viviparusfor 6 weeks.
Contraindications
None known.
See Section 4.11.
Special warnings for each target species
None
Special precautions for use
Special precautions for use in animals
For topical application only.
All animals in a group should be treated.
To avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or the spine, it is recommended to administer the productat the end of the period of fly activity and before the larvae reach their resting sites: consult the veterinarian to know the correct treatment period.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not smoke, eat or drink while handling the product.
Avoid direct contact with skin and eyes.
Wash hands after use.
Protective clothes and gloves are recommended when using the product.
If splashed in the eye or on the skin, wash with plenty of clean, running water immediately.
Adverse reactions (frequency and seriousness)
Reactions at the site of application may occur after application in extremely rare occasions.
Use during pregnancy, lactation or lay
Moxidectin has been shown to be safe for use in pregnant and lactating animals and breeding bulls.
See Section 4.11.
Interactions with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
500 µg moxidectin/kg body weight (1 ml for 10 kg)as a single topical application.
To be administered along the midline of the back of the animal from the withers to the tailhead.
Apply to clean healthy skin.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No symptoms of overdose have been observed with the product given at ten times the recommended dose.
They are manifested as transient salivation, depression, drowsiness and ataxia. There is no specific antidote.
Withdrawal periods
Meat and offal : 14 days.
Milk : 6 days (144 hours).
PHARMACOLOGICAL PROPERTIES
ATC Vet Code: QP54AB02
Therapeutic group: ; endectocide (milbemycin family)
Pharmacodynamic properties
Moxidectin is a parasiticide active against a wide range of important internal and external parasites. It is a second generation macrocyclic lactone of the milbemycin family. Its principal mode of action is interference with the GABA (gamma amino butyric acid) receptors involved with neuromuscular transmission.
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 results in flaccid paralysis and eventual death of parasites exposed to the drug.
Pharmacokinetic particulars
Following pour-on application, the drug is distributed throughout the body tissues (except muscle) but due to its lipophilicity the concentrations in fat are 5-15 times those in other tissues.
Moxidectin undergoes partial biotransformation by hydroxylation in the body and the only significant route of excretion is the faeces, where the parent compound accounts for approximately 50%.
PHARMACEUTICAL PARTICULARS
List of excipients
Aromatic Solvent
Myristal Propoxylate Propionic Ester
Polybutene Polymer
Propylene Glycol
Butylated hydroxyanisole (E320)
Tertiary Butylhydroquinone
Citric Acid Monohydrate (E330)
Fractionated coconut oil
Incompatibilities
Not to be mixed with other Veterinary Medicinal Products before administration.
Shelf life
24 months.
After first opening: 6 months.
Special precautions for storage
Keep the container in the outer carton to protect from light.
Do not store above 25°C.
If accidentally frozen, shake vigorously before use.
Nature and composition of immediate packaging
500, 1000, 2500 and 5000 ml fluorinated high-density polyethylene containers.
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 aquatic organisms.
Avoid spillage directly into water courses.
Any unused product or waste material should be disposed of in accordance with national requirements.
MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
5th Floor, 6 St. Andrew Street
London
EC4A 3AE
MARKETING AUTHORISATION NUMBERS
Vm:42058/4025
DATE OF FIRST AUTHORISATION
Date:10 January 1997
DATE OF REVISION OF THE TEXT
Date: October 2013
PROHIBITION OF SUPPLY, SALE AND/OR USE
To be completed nationally.
09 December 2013
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