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Date: Thursday, June 13, 2024 16:15

Release 4.135
Cydectin 20 mg/ml LA Solution for Injection for Sheep
 
Species: Sheep
Therapeutic indication: Pharmaceuticals: Endectocides: For sheep
Active ingredient: Moxidectin
Product:CYDECTIN® 20 mg/ml LA Solution for Injection for Sheep
Product index: CYDECTIN 20 mg/ml LA Solution for Injection for Sheep
Sheep - meat: 104 days
Withdrawal notes: Milk: Not permitted for use in dairy sheep, at any stage of life.
Incorporating:
Presentation
A clear yellow solution for injection containing moxidectin 20 mg/ml as the active substance and the excipient benzyl alcohol 70 mg/ml.
Uses
Treatment and prevention of mixed infections of gastro-intestinal nematodes, respiratory nematodes and certain arthropod parasites in sheep.
Moxidectin is indicated for treatment of infections caused by moxidectin sensitive strains of:
Gastro-intestinal nematodes:
Haemonchus contortus (adults and L3)
Ostertagia (Teladorsagia) circumcincta (adults and L3, including inhibited larvae)
Trichostrongylus axei (adults)
Trichostrongylus colubriformis (adults and L3)
Nematodirus spathiger (adults)
Cooperia curticei (macmasteri) (adults)
Cooperia punctata (adults)
Oesophagostomum columbianum (L3)
Chabertia ovina (adults)
Respiratory tract nematodes:
Dictyocaulus filaria (adults)
Larvae of Diptera:
Oestrus ovis: L1, L2, L3
Mange mites:
Psoroptes ovis
The product has a persistent action and protects sheep against infection or re-infection with the following parasites for the period indicated:
Species
Days
Ostertagia (Teladorsagia) circumcincta
97
Haemonchus contortus
111
Trichostrongylus colubriformis
44
Psoroptes ovis
60
Persistent efficacy periods have not been established for parasite species other than those included in the list above. Therefore, re-infection of animals on pasture contaminated by parasites other than these remains possible before the 44-day minimum persistency period demonstrated for specific species.
Dosage and administration
Subcutaneous use.
Dosage is 0.5 ml/10 kg bodyweight to give 1 mg moxidectin/kg bodyweight. The 50 ml vial stoppers must not be broached more than 10 times. Use automatic syringe equipment for the 200 ml and 500 ml vials.
Use the following table as a guide:
No of doses per pack
Weight of sheep kg
Dose ml
50 ml
200 ml
500 ml
20
1.0
50
200
500
30
1.5
33
133
333
40
2.0
25
100
250
50
2.5
20
80
200
60
3.0
17
67
167
70
3.5
14
57
143
80
4.0
13
50
125
90
4.5
11
44
111
100
5.0
10
40
100
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device 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.
The injection should be administered as a single subcutaneous injection at the base of the ear using an 18 gauge, 25 mm hypodermic needle. With the animal's head under control, the formulation should be administered about 2cm caudal from the anterior (rostral) edge of the pinna at the base of the ear. The skin at the base of the selected ear should be pinched and the product injected into the subcutaneous tissue. Following subcutaneous administration, the needle should be withdrawn from the skin as pressure is applied with the thumb at the point of insertion for several seconds. If leakage occurs then pressure should be applied for several additional seconds.
Diagram: Ear injection technique
Description:...
Contra-indications, warnings, etc
Do not use in sheep less than 15 kg bodyweight.
Do not inject the product by the intravascular route. Intravascular injection may result in ataxia, paralysis, convulsions, collapse and death. See “Dosage and administration” section above.
Do not use in cases of hypersensitivity to the active substance or to any excipients.
Sheep:
Very common
(>1 animal / 10 animals treated):
Injection site swelling1
Injection site inflammation
Rare
(1 to 10 animals / 10,000 animals treated):
Increased salivation2
Ataxia2, Drowsiness2
Depression2
1generally resolves without treatment within 7 days.
2transitory, no specific antidote, no particular treatment is required; these symptoms usually disappear within 24 to 48 hours.
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 the national competent authority via the national reporting system. See also the package leaflet for the respective contact details.
Signs of overdoses have not been seen at 3 and 5 times the recommended dose. However, if they do occur they should be consistent with the mode of action of moxidectin and would be manifested as transient salivation, depression, drowsiness and ataxia 24 to 36 hours post-treatment. The signs would usually disappear within 36 to 72 hours without treatment. There is no specific antidote.
The product has been formulated specifically for subcutaneous injection in the base of the ear of sheep and must not be given by any other route of administration or to any other 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.
- Underdosing, which may be due to underestimation of bodyweight, 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 moxidectin should be based on local (regional, farm) epidemiological information about susceptibility of nematodes, local history of treatments and recommendations on how to use the product under sustainable conditions to limit further selection for resistance to anthelmintics. These precautions are especially important when moxidectin is being used to control resistant strains.
Trials have shown that moxidectin is effective against certain strains of Haemonchus contortus, Teladorsagia circumcinta and Trichostrongylus spp. resistant to benzimidazoles.
Withdrawal period
Meat and offal: 104 days.
Milk: Not permitted for use in dairy sheep, at any stage of life.
The withdrawal period is based solely on a single injection at the base of the ear.
Operator warnings
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. If this occurs, it is unlikely that any product related symptoms will be observed. Advice to Medical Practitioners in case of accidental self-injection: treat symptomatically.
Special precautions for the protection of 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 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, 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 injectable formulation to sheep, treated animals should not have access to watercourses during the first 11 days after treatment.
Pharmaceutical precautions
Do not store above 25°C.
Keep the container in the outer carton to protect from light.
Do not use after the expiry date stated on the carton/label after Exp.
Shelf-life after first opening the container: 28 days.
When the container is broached (opened) for the first time, using the in-use shelf life which is specified on this package leaflet, 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.
Medicines should not be disposed of via wastewater or household waste. 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. Extremely dangerous 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
The product is packaged in 50 ml, 200 ml and 500 ml HDPE containers. Not all pack sizes may be marketed.
Further information
Moxidectin is a member of the 3-ML anthelmintic class.
Marketing Authorisation Number
UK (GB): Vm 42058/5117
UK (NI): Vm 42058/3017
Significant changes
GTIN
GTIN description:50 ml:
GTIN:08714015021906
GTIN description:200 ml:
GTIN:08714015021913
GTIN description:500 ml:
GTIN:08714015021920