Contraindications
Do not use this veterinary medicinal product intravenously or intramuscularly.
This veterinary medicinal product 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 cases of hypersensitivity 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 veterinary medicinal 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 Ostertagia ostertagi and Cooperia spp. in cattle within the EU. Therefore, the use of this veterinary medicinal 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
Special precautions for safe use in the target species:
This veterinary medicinal 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 veterinary medicinal 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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not eat, drink or smoke whilst handling the veterinary medicinal product.
Wash hands after use.
Direct contact with the skin should be avoided.
Personal protective equipment consisting of gloves and glasses should be worn when handling the veterinary medicinal product.
Take care to avoid self-injection: the veterinary medicinal product may cause local irritation and/or pain at the site of injection.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
The veterinary medicinal product is very toxic to aquatic organisms and dung insects. Treated cattle should not have direct access to ponds, streams or ditches for 14 days after treatment. Long term effects on dung insects caused by continuous or repeated use cannot be excluded. Therefore repeated treatment of animals on a pasture with an ivermectin-containing product within a season should only be given in the absence of alternative treatments or approaches to maintain animal/flock health, as advised by a veterinarian.
Adverse reactions
Cattles:
Undetermined frequency (cannot be estimated from the avaiable data): | injection site pain1 Injection site swelling.2 |
1Transitory discomfort
2Soft-tissue reaction, resolve over time without treatment
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 the package leaflet for respective contact details.
Pregnancy, lactation and fertility
Pregnancy:
Can be used during pregnancy.
Lactation:
Can be used during lactation.
Can be used in breeding animals.
Overdose (symptoms, emergency procedures, antidotes)
A dose of 25ml per 50kg bodyweight (25 times the recommended dose level) may result in injection site lesions, including tissue necrosis, oedema, fibrosis and inflammation.
No other drug-related reactions have been observed.
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.