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Date: Sunday, October 20, 2019 3:47

Release 3.17
Ivomec Super Injection for Cattle
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for cattle, Combination fluke/wormers, For cattle, For cattle
Active ingredient: Clorsulon, Ivermectin
Product:Ivomec Super Injection for Cattle
Product index: Ivomec Super Injection
Cattle - milk: See note
Cattle - meat: 66 days
Withdrawal notes: Animals must not be slaughtered for human consumption during treatment. Do not use in cattle producing milk for human consumption and in non-lactating dairy cows including pregnant heifers within 60 days of calving.
Qualitative and quantitative composition
Per ml:
Ivermectin 10 mg
Clorsulon 100 mg
For the full list of excipients, see below.
Pharmaceutical form
Solution for injection.
Clinical particulars
Target species
Cattle.
Indications for use
IVOMEC Super Injection for Cattle is indicated for the treatment and control of the following parasites:
Gastrointestinal Roundworms (Adult, L4 and Inhibited L4)
Ostertagia ostertagi
Gastrointestinal Roundworms (Adult and L4)
Ostertagia lyrata
Haemonchus placei
Trichostrongylus axei
T. colubriformis
Cooperia oncophora
C. punctata
C. pectinata
Bunostomum phlebotomum
Oesophagostomum radiatum
Gastrointestinal Roundworms (Adult)
Strongyloides papillosus
Nematodirus helvetianus
N. spathiger
Trichuris spp.
Lungworms (Adult and L4)
Dictyocaulus viviparus
Liver Fluke (Adult)
Fasciola hepatica
Eye Worms (Adult)
Thelazia spp.
Warbles (parasitic stages)
Hypoderma bovis
H. lineatum
Mange Mites
Psoroptes bovis
Sarcoptes scabiei var. bovis
Sucking Lice
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
Ivomec Super Injection for Cattle may also be used as an aid in the control of biting lice (Damalinia bovis) and the mange mite Chorioptes bovis, but complete elimination may not occur.
Persistent Activity
Ivomec Super Injection for Cattle given at the recommended dosage of 0.2 mg per kg bodyweight controls re-infection with Haemonchus placei, Cooperia spp. and Trichostrongylus axei acquired up to 14 days after treatment; Ostertagia ostertagi and Oesophagostomum radiatum acquired up to 21 days after treatment and Dictyocaulus viviparus acquired up to 28 days after treatment.
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.
Contra-indications
Do not use intramuscularly or intravenously. IVOMEC Super Injection for Cattle is a low-volume product registered for use in cattle. Do not use in other species as severe adverse reactions, including fatalities in dogs, may occur.
Special warnings for each target species
For use only in beef cattle and non-lactating dairy cattle. 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 (which includes ivermectin) has been reported in Cooperia spp. in cattle within the EU. Therefore, the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.
Special precautions for use in animals
This product does not contain any antimicrobial preservative. Swab septum before removing each dose.
Special precautions to be taken by the person administering the product to animals
Do not smoke, drink or eat while 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.
Adverse reactions
Transitory 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.
Use during pregnancy, lactation or lay
IVOMEC Super Injection for Cattle can be administered to beef cows at any stage of pregnancy or lactation provided that the milk is not intended for human consumption. IVOMEC Super Injection for Cattle will not affect the fertility of cows and bulls and can be given to all ages of animals including young calves.
Interactions
No interactions have been identified with other products.
Amounts to be administered and administration route
IVOMEC Super should be administered only by subcutaneous injection at the recommended dosage level of 1 ml/50 kg bodyweight (based on a dosage level of 200 mcg ivermectin plus 2 mg clorsulon per kg bodyweight) under the loose skin in front of, or behind, the shoulder. Divide doses greater than 10 ml between two injection sites. A sterile 17 gauge ½ inch (15-20 mm) needle is recommended. Replace with a fresh sterile needle after every 10-12 animals or sooner if the needle becomes soiled.
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked. When the temperature of the product is below 5 °C, difficulty in administration may be encountered due to increased viscosity.
Warming the product and injection equipment to about 15 °C will greatly increase the ease with which the product can be injected. Different injection sites should be used for other parenteral products administered concurrently. When using the 200 ml, 500 ml and 1000 ml pack sizes, use only automatic syringe equipment. For the 50 ml pack sizes, use of a multidose syringe is recommended.
Overdose
The administration of 25 ml Ivomec Super per 50 kg bodyweight (25 x the use level) resulted in an injection site lesion (including tissue necrosis, oedema, fibrosis and inflammation). No other drug-related adverse reactions could be determined.
Withdrawal periods
Animals must not be slaughtered for human consumption during treatment.
Cattle (meat & offal) – 66 days.
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 particulars
Excipients
Glycerol Formal, Propylene Glycol.
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 5 years.
Shelf-life after first opening the immediate packaging: 6 months
Special precautions for storage
Protect from direct sunlight. Following withdrawal of the first dose, use the product within 6 months. Discard unused material.
Immediate packaging
50 ml, 200 ml, 500 ml and 1000 ml containers.
Disposal
EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with product or used container. Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 08327/4167
Significant changes
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Ivomec Super Injection for Cattle 50 ml
GTIN:03661103019350
GTIN description:Ivomec Super Injection for Cattle 200 ml
GTIN:03661103019367
GTIN description:Ivomec Super Injection for Cattle 500 ml
GTIN:03661103019374
GTIN description:Ivomec Super Injection for Cattle 1000 ml
GTIN:03661103019381