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Date: Monday, October 7, 2024 4:21

Release 3.121
Animec Super 10 mg/ml / 100 mg/ml Solution for Injection for Cattle
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Combination fluke/wormers
Active ingredient: Clorsulon, Ivermectin
Product:Animec Super 10 mg/ml / 100 mg/ml Solution for Injection for Cattle
Product index: Animec Super Injection for Cattle
Cattle - milk: See notes
Cattle - meat: 66 days
Withdrawal notes: Do not use in cattle producing milk for human consumption. Do not use in non-lactating dairy cows including pregnant heifers within 60 days of calving.
Incorporating:
Presentation
A clear colourless to pale yellow coloured sterile solution containing 10mg/ml ivermectin and 100mg/ml clorsulon.
Uses
For the treatment of mixed infestations of adult liver fluke and gastro-intestinal roundworms, lungworms, eye worms, and/or mites and lice of beef and non lactating dairy cattle.
Animec Super Injection is a broad-spectrum endo- and ecto-parasiticide. One dose is effective against many parasites. It is convenient to use.
Animec Super Injection treats:
PARASITE
Adult
L4
Inhibited L4
Gastrointestinal roundworms
Ostertagia ostertagi
+
+
+
Ostertagia lyrata
+
+
Haemonchus placei
+
+
Trichostrongylus axei
+
+
Trichostrongylus colubriformis
+
+
Cooperia oncophora
+
+
Cooperia punctata
+
+
Cooperia pectinata
+
+
Oesophagostomum radiatum
+
+
Strongyloides papillosus
+
Nematodirus helvetianus
+
Nematodirus spathiger
+
Trichuris spp.
+
Lungworms
Dictyocaulus viviparus
+
+
Eye worms
Thelazia spp.
+
PARASITE
Adult
Immature
Liver fluke
Fasciola hepatica
+
Warbles (parasitic stages)
Hypoderma bovis
+
H. lineatum
+
Mange Mites
Psoroptes bovis
+
+
Sarcoptes scabiei var bovis
+
+
Sucking Lice
Linognathus vituli
+
+
Haematopinus eurysternus
+
+
Solenopotes capillatus
+
+
Prolonged activity
When cattle have to graze on pasture contaminated with infective larvae of cattle nematodes, Animec Super Injection given at the recommended dosage of 1ml per 50kg bodyweight controls re-infection with the following nematodes up to the duration shown:
Parasite
No. of days after treatment
Barber’s pole worm – Haemonchus placei
14
Small intestinal worm – Cooperia spp
14
Hairworm – Trichostrongylus axei
14
Brown stomach worm – Ostertagia ostertagi
21
Nodular worm – Oesophagostomum radiatum
21
Lungworm – Dictyocaulus viviparus
28
Animec Super may also be used as an aid in the treatment of biting lice (Damalinia bovis) and the mange mite (Chorioptes bovis), but complete elimination may not occur.
Dosage and administration
Dosage: 1ml per 50 kg bodyweight by subcutaneous injection (based on a recommended dosage level of 200µg of ivermectin and 2mg of clorsulon per kg bodyweight). For example:
Bodyweight (kg)
Dose volume
(ml)
Doses per 50ml pack
Doses per 250ml pack
Doses per 500ml pack
Up to 50
1
50
250
500
51-100
2
25
125
250
101-150
3
16
83
166
151-200
4
12
62
125
201-250
5
10
50
100
251-300
6
8
40
83
Over 300kg give 1ml per 50kg bodyweight.
To ensure a correct dosage, 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, to avoid under- or over-dosing, they should be grouped according to their bodyweight and dosed accordingly. Inject only by the subcutaneous route.
Divide doses in excess of 10ml between different injection sites.
The timing of treatment should be based on epidemiological factors and should be customised for each individual farm. A dosing program should be established by a qualified professional person.
A sterile 17 gauge ½ inch (15-20 mm) needle is recommended.
Different injection sites should be used for other parenteral products administered concurrently. When using the 500 ml pack size use only automatic syringe equipment. For the 50 ml pack size, use of a multidose syringe is recommended.
The product should be administered under the loose skin in front of or behind the shoulder.
Contra-indications, warnings, etc
Do not use this product intravenously or intramuscularly.
Animec Super Injection is a low volume product authorised for use in cattle. It must not be used in other species as severe adverse reactions, including fatalities in dogs, may occur, especially Collies, Old English Sheepdogs and related breeds and crosses. Do not use in animals with a known sensitivity to the active ingredient or to any of the excipients.
Special warnings
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 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.
Special precautions for use in animals
This product does not contain any antimicrobial preservative - swab septum before removing each dose.
To avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or the spine, it is recommended to administer the product at the end of the period of fly activity and before the larvae reach their resting sites: seek professional advice on the correct timing of treatment.
Divide doses in excess of 10 ml between different injection sites and use different sites to those used for other parenteral medications.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not smoke or eat whilst handling the product. Wash hands after use.
Take care to avoid self-injection: the product may cause local irritation and/or pain at the injection site. In case of accidental self-injection, seek medical advice and show the label to the doctor.
Direct contact with the skin should be avoided.
Other precautions
Treated cattle should not have direct access to ponds, streams or ditches for 14 days after treatment.
Adverse reactions
Transient discomfort has been observed in some cattle following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed. These reactions disappeared without treatment. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Pregnancy, lactation and fertility
Can be used in pregnancy and lactation. Can be used in breeding animals.
Overdose (symptoms, emergency procedures, antidotes)
A dose of 25ml product per 50kg bodyweight (25 times the recommended dose level) may result in an injection site lesion, including tissue necrosis, oedema, fibrosis and inflammation.
Interaction with other medicinal products and other forms of interaction
None known.
Incompatibilities
In the absence of compatibilities studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Withdrawal periods
Meat and offal: 66 days.
Milk: Do not use in cattle producing milk for human consumption. Do not use in non-lactating dairy cows including pregnant heifers within 60 days of calving.
Pharmaceutical precautions
Protect from light. Keep the container in the outer carton in order to protect from light.
Shelf-life of the veterinary medicinal product after withdrawal of the first dose: 28 days.Discard unused material.
Special precautions for the disposal of unused product or waste material if any
EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with the product or used container. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Legal category
Legal category: POM-VPS
Packaging quantities
50ml, 250ml and 500ml containers
Further information
Ivermectin acts on the nervous system of nematode and arthropod parasites. It first paralyses, then kills them. At therapeutic usage rates it has no effect on the nervous system of cattle.
Clorsulon acts on enzymes involved in energy generation in liver fluke. At therapeutic usage rates it has no effect on the equivalent systems of cattle.
At the recommended usage rate Animec Super Solution for Injection for Cattle has no adverse effects on breeding performance of cattle. At therapeutic usage rates it has no effect on the nervous system of cattle.
Marketing Authorisation Number
Vm 11990/4054
Significant changes