4.1 Target species
Cattle (beef and dairy cattle).
4.2 Indications for use, specifying the target species
Treatment of infestations by the following parasites sensitive to eprinomectin:
Cattle:
PARASITE ADULT L4 Inhibited L4
Gastrointestinal roundworms
Ostertagia ostertagi
Ostertagia lyrata
Haemonchus placei
Trichostrongylus axei
Trichostrongylus colubriformis
Cooperia spp.
Cooperia oncophora
Cooperia punctata
Cooperia pectinata
Cooperia surnabada
Bunostomum phlebotomum
Nematodirus helvetianus
Oesophagostomum radiatum
Oesophagostomum sp.
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
XIssued: May 2018
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Trichuris discolor X
Lungworms
Dictyocaulus viviparus X X
- Warbles (parasitic stages):
Hypoderma bovis
Hypoderma lineatum
- Mange mites:
Chorioptes bovis
Sarcoptes scabiei var. Bovis
- Sucking lice:
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
- Biting lice:
Bovicola (Damalinia) bovis
- Horn flies:
Haematobia irritans
The product protects the animals against reinfestations with:
- Nematodirus helvetianus for 14 days.
- Trichostrongylus axei for 21 days.
- Dictyocaulus viviparus, Haemonchus placei, Cooperia oncophora, Cooperia
punctata, Cooperia surnabada, Oesophagostomum radiatum and Ostertagia
ostertagi for 28 days.
The duration of persistent efficacy can be variable for Cooperia spp and H. placei 14
days after treatment in particular in young and lean animals at the time of treatment.
4.3 Contraindications
Avermectins may not be well tolerated in non-target species (including dogs, cats
and horses). Cases of mortality are reported in dogs, especially Collies, bobtail and
related breeds and crosses, and also in turtles/tortoises.
Do not use in other animal species.
Do not administer orally or by injection.
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
4.4 Special warnings for each target 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.Issued: May 2018
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- 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.
To date no resistance to eprinomectin (a macrocyclic lactone) has been reported in
cattle within the EU. However, resistance to other macrocyclic lactones has been
reported in parasite species in cattle within the EU. Therefore, 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.
If there is a risk for re- infection, the advice of a veterinarian should be sought
regarding the need for and frequency of repeat administration.
For the best results the product should be part of a programme to control both
internal and external parasites of cattle based on the epidemiology of these
parasites.
4.5 Special precautions for use
Special precautions for use in animals
For external use only.
For effective use, the product should not be applied to areas of the backline covered
with mud or manure.
The product should be applied only on healthy skin.
To avoid adverse reactions due to the death of warble larvae in the oesophagus or
backbone, it is recommended to administer the product after the end of warble fly
activity and before the larvae reach their resting sites in the body; consult a
veterinary surgeon to know the appropriate treatment period.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
This product may be irritating to the skin and eyes and may cause hypersensitivity
(allergic reactions).
Avoid contact with the skin and eyes during treatment and when handling recently
treated animals.
People with known hypersensitivity to eprinomectin should avoid contact with the
product.
Wear rubber gloves, boots and a waterproof coat when applying the product.
If accidental skin contact occurs, wash the affected area immediately with soap and
water. If accidental eye exposure occurs, flush the eyes immediately with water.
Should clothing become contaminated, remove as soon as possible and launder
before re-use.
This product may affect the central nervous system if accidentally ingested. Avoid
accidental ingestion of the product, including by hand to mouth contact. If ingestion
does occur, wash the mouth out with water and seek medical advice.Issued: May 2018
AN: 01487/2016
Page 4 of 7
Do not smoke, eat or drink while handling the product.
Wash hands after use.
Other precautions
Eprinomectin is very toxic to aquatic organisms, is persistent in soils and may
accumulate in sediments.
Faeces containing eprinomectin excreted onto pasture by treated animals may
temporarily reduce the abundance of dung feeding organisms. Following treatment of
cattle with the product, levels of eprinomectin 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.
In case of repeated treatments with eprinomectin (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.
Eprinomectin is inherently toxic to aquatic organisms. The product should be used
only according to the label instructions. Based on the excretion profile of
eprinomectin when administered as the pour-on formulation, treated animals should
not have access to watercourses during the first 7 days after treatment.
4.6 Adverse reactions (frequency and seriousness)
In very rare cases, transient licking reactions, skin tremor at the administration site,
minor local reactions such as the occurrence of dandruff and skin scales at the
administration site have been observed.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
4.7 Use during pregnancy, lactation or lay
Laboratory studies (rat, rabbit) have not produced any evidence of a teratogenic or
embryotoxic effects due to the use of eprinomectin at therapeutic doses. The safety
of the veterinary medicinal product in cattle has been established during pregnancy
and lactation and in reproductive bulls.
Can be used during pregnancy and lactation as well as in reproductive bulls.
4.8 Interaction with other medicinal products and other forms of interaction
Since eprinomectin binds strongly to plasma proteins, this should be taken into
account if it is used in association with other molecules having the same
characteristics.
Vat Rate: 20%