NOAH Compendium

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Date: Tuesday, November 24, 2020 18:41

Release 3.140
Eprinex Multi 5 mg/ml pour-on for beef and dairy cattle, sheep and goats
Species: Cattle, Goats, Sheep
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for cattle, Anthelmintics for sheep, Anthelmintics for goats, For cattle, For cattle
Active ingredient: Eprinomectin
Product:Eprinex Multi 5 mg/ml pour-on for beef and dairy cattle, sheep and goats
Product index: Eprinex Multi
Cattle - milk: Zero hours
Cattle - meat: 15 days
Sheep - meat: 2 days
Withdrawal notes: Meat and Offal: Cattle - 15 days; Sheep - 2 days; Goats - 1 day. Milk - zero hours for cattle, sheep and goats.
Qualitative and quantitative composition
Each ml contains:
Active substance:
Eprinomectin 5.0 mg
Excipients:
Butylhydroxytoluene (E321) 0.1 mg
Alpha-tocopherol max. 0.06 mg
For the full list of excipients, see below
Pharmaceutical form
Pour-on solution. Clear slightly yellow solution.
Clinical particulars
Target Species
Beef and dairy cattle, sheep and goats.
Indications for Use
Treatment of infestation by the following parasites sensitive to eprinomectin:
Cattle
Gastrointestinal Roundworms (Adult, L4 and Inhibited L4)
Ostertagia ostertagi
Cooperia spp.
Gastrointestinal Roundworms (Adult and L4)
Ostertagia spp.
Cooperia oncophora
Cooperia pectinata
Cooperia punctata
Cooperia surnabada
Haemonchus placei
Trichostongylus spp.
Trichostrongylus axei
Trichostrongylus colubriformis
Bunostomum phlebotomum
Nematodirus helvetianus
Oesophagostomum radiatum
Gastrointestinal roundworms (Adult)
Ostertagia lyrata
Oesophagostomum spp.
Trichuris spp.
Lungworms (Adult and L4)
Dictyocaulus viviparus
Warbles (parasitic stages)
Hypoderma bovis
Hypoderma lineatum
Mange mites
Chorioptes bovis
Sarcoptes scabiei var bovis
Lice
Damalinia bovis
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
Flies
Haematobia irritans
PROLONGED ACTIVITY
Applied as recommended, the product prevents reinfestations with:
Parasite
Prolonged Activity
Dictyocaulus viviparus
Up to 28 days
Ostertagia ostertagi
Up to 28 days
Oesophagostomum radiatum
Up to 28 days
Cooperia punctata
Up to 28 days
Cooperia surnabada
Up to 28 days
Cooperia oncophora
Up to 28 days
Nematodirus helvetianus
Up to 14 days
Trichostrongylus colubriformis
Up to 21 days
Trichostrongylus axei
Up to 21 days
Haemonchus placei
Up to 21 days
For best results Eprinex Multi should be part of a programme to control both internal and external parasites of cattle based on the epidemiology of these parasites.
Sheep
Gastrointestinal roundworms (adults)
Teladorsagia circumcincta (pinnata/trifurcata)
Haemonchus contortus
Trichostrongylus axei
Trichostrongylus colubriformis
Nematodirus battus
Cooperia curticei
Chabertia ovina
Oesophagostomum venulosum
Lungworm (adult)
Dictyocaulus filaria
Goats
Gastrointestinal roundworms (adult)
Teladorsagia circumcincta (pinnata/trifurcata)
Haemonchus contortus
Trichostrongylus axei
Trichostrongylus colubriformis
Nematodirus battus
Cooperia curticei
Oesophagotomum venulosum
Lungworm (adult)
Dictyocaulus filaria
Contraindications
This product is formulated only for topical application to cattle, sheep and goats including lactating dairy animals. Do not use in other animal species.Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
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.
In cattle, rainfall before, during or after the application of the product, has been shown to have no impact on its efficacy. It also has been demonstrated that haircoat length has no impact on the product’s efficacy. The effect of rainfall and haircoat length on efficacy has not been evaluated in sheep and goats.
For cattle, in order to limit cross-transfer of eprinomectin, treated animals may be separated from untreated animals. Non-compliance with this recommendation may lead to residue violations in untreated animals.
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.
To date no resistance to eprinomectin (a macrocyclic lactone) has been reported in cattle and sheep while resistance to eprinomectin has been reported in goats within the EU. However resistance to other macrocyclic lactones has been reported in nematode populations in cattle, sheep and goats within the EU, which may be associated with side-resistance to eprinomectin. 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.
While mite and louse numbers decline rapidly following treatment, due to the feeding habits of some mites, in some cases several weeks may be required for complete eradication.
Special Precautions for use in animals
For external use only. Not to be used in other species; avermectins can cause fatalities in dogs, especially Collies, Old English Sheepdogs and related breeds and crosses, and also in turtles/tortoises. To avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or in the spine, it is recommended to administer the product at the end of warble fly activity and before the larvae reach their resting sites.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not smoke, eat or drink while handling the product.
Wash hands after use.
This product may be irritating to skin and eyes. Avoid contact with eyes and skin.
People with known hypersensitivity to the active substance or to any of the excipients should avoid contact with the product.
Operators should wear rubber gloves, boots and waterproof coat when applying the product.
Should clothing become contaminated, remove as soon as possible and launder before re-use.
If accidental skin contact occurs, wash the affected area immediately with soap and water.
Should accidental eye exposure occur, flush eyes immediately with plenty of clean water. Should irritation persist, seek medical advice.
Do not ingest.
In case of accidental ingestion, rinse out mouth thoroughly with water, seek medical advice immediately and show the package insert or the label to the physician.
Other precautions
Eprinomectin is very toxic to dung fauna and aquatic organisms, is persistent in soils and may accumulate in sediments. The risk to aquatic ecosystems and dung fauna can be reduced by avoiding repeated use of eprinomectin (and products of the same anthelmintic class). In order to reduce the risk to aquatic ecosystems, treated animals should not have direct access to water bodies for a minimum of two weeks after treatment.
Adverse Reactions
In very rare cases, pruritus and alopecia have been observed after the use of the veterinary medicinal product.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- 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).
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. Laboratory studies in cattle have not produced any evidence of a teratogenic or foetotoxic effect at the recommended therapeutic dose. The product can be used in dairy cattle during pregnancy and lactation.
The safety of eprinomectin during pregnancy in sheep and goats has not been tested. Use only according to the benefit/risk assessment of the responsible veterinarian in these species.
Interactions
No interactions with other medicines and no other forms of interactions are known. Since eprinomectin binds extensively to plasmatic proteins, this should be taken into account if it is used in association with other molecules having the same characteristics.
Amounts to be administered and administration route
Pour-on use.
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- and over- dosing.
The product should be applied topically by pouring along the backline in a narrow strip extending from the withers to the tailhead.
Cattle:
Administer by topical application at the dose rate of 0.5 mg eprinomectin per kg bodyweight, corresponding to the recommended dose rate of 1 ml per 10 kg bodyweight.
Sheep and goats:
Administer by topical application at the dose rate of 1.0 mg eprinomectin per kg bodyweight, corresponding to the recommended dose rate of 2 ml per 10 kg bodyweight.
When administering the product along the backline, part the fleece/coat and place applicator nozzle or bottle spout against the skin.
Method of administration
For 250 ml and 1 litre bottles:
• Attach the metering cup to the bottle.
• Set the dose by turning the top section of the cup to align the correct bodyweight with the pointer on the knurled cap. When bodyweight is between markings, use the higher setting.
• Hold the bottle upright and squeeze it to deliver a slight excess of the required dose. Release the pressure and tilt the bottle to deliver the dose. For the 1 litre bottle: when a 10 ml or 15 ml dose is required, turn the pointer to “STOP” before delivering the dose. The off (STOP) position will close the system between dosing.
• The dosing cup should not be stored attached to the bottle when not in use. Remove the cup after each use and replace with the bottle cap.
For 2.5 and 5 litre:
• Attach the open end of the draw-off tubing to an appropriate dosing gun.
• Attach draw-off tubing to the cap with the stem that is included in the pack. Replace shipping cap with the cap having the draw-off tubing. Tighten the draw-off cap.
• Gently prime the dosing gun, checking for leaks.
• Follow the dosing gun manufacturer’s directions for adjusting the dose.
Overdose
No signs of toxicity were observed when 8-week old calves were treated at up to 5 times the therapeutic dose (2.5 mg eprinomectin/kg bodyweight.) 3 times at 7-day intervals.
One calf treated once at 10 times the therapeutic dose (5 mg/kg bodyweight.) in the tolerance study showed transient mydriasis. There were no other adverse reactions to the treatment.
No signs of toxicity were observed when 17-week old sheep were treated at doses up to 5 times the therapeutic dose (5 mg eprinomectin/kg bodyweight) 3 times at 14-day intervals.
No antidote has been identified.
Withdrawal Periods
Cattle:
Meat and offal: 15 days. Milk: zero hours.
Sheep:
Meat and offal: 2 days. Milk: zero hours
Goats:
Meat and offal: 1 day. Milk: zero hours
Pharmacological particulars
Pharmacodynamic properties
Eprinomectin is a member of the macrocyclic lactone class of endectocides. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve or muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite.
Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA).
The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels; the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels, and they do not readily cross the blood-brain barrier.
Pharmacokinetic particulars
Eprinomectin is bound extensively to plasma proteins (99%).
Pharmacokinetic studies have been conducted in lactating and non-lactating animals, administered topically at a single dosage of 0.5 mg/kg body weight in cattle and at 1 mg/kg bodyweight in sheep and goats.
For cattle, results from two representative studies found mean peak plasma concentrations of 9.7 and 43.8 ng/ml that were observed at 4.8 and 2.0 days post dose. The corresponding elimination half-lives in plasma were 5.2 and 2.0 days, and mean area-under-the-curve values of 124 and 241 ng*day/ml.
Eprinomectin is not extensively metabolized in cattle following topical administration.
Faeces was the major route of elimination of the drug in beef cattle and dairy cows.
For sheep, a mean peak plasma concentration (Cmax) of 6.20 ng/ml was observed following a topical dose of 1mg/kg. The half-life in plasma was 6.4 days with mean area under the curve (AUC last) value of 48.8 ng*day/ml.
For goats, peak mean plasma concentrations ranging from 3 to 13.1 ng/ml were observed from day 1 to day 2 post dose. The half life in plasma ranged from less than one day to 3 days with area under the curve mean values ranging from 15.7 to 39.1 ng-day/ml.
An in vitro microsomal metabolism study was conducted using liver microsomes isolated from cattle, sheep and goats. It showed that the differences in pharmacokinetics observed between cattle, sheep and goats do not result from differences in the rate or extent of metabolism but suggests more complete absorption of eprinomectin by cattle.
Pharmaceutical particulars
Excipients
Butylhydroxytoluene (E321), Propylene glycol dicaprylocaprate, Alpha-tocopherol
Major 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: 3 years.
Shelf life after first opening the immediate packaging: see expiry date.
Special precautions for storage
Keep the container in the outer carton in order to protect from light. This veterinary medicinal product does not require any special temperature storage conditions. Store container upright.
Immediate Packaging
250 ml and 1L HDPE bottle. 2.5 and 5L HDPE back pack. Sealed foil and tamper evident HDPE screw cap with polypropylene liner.
250 ml bottle with 2 measuring devices of 25 ml (1 for cattle, 1 for sheep/goat). 1L bottle with 2 measuring devices (1 of 60 ml for cattle, 1 of 25 ml for sheep/goat). 2.5L back-pack with a dispensing cap. 5L back-pack with a dispensing cap.
One bottle or one back-pack per cardboard box.
The 2.5 litre and 5 litre back-packs are designed for use with a suitable automatic dispensing gun. Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. Do not contaminate surface waters or ditches with the product or used container.
Environmental Properties
Like other macrocyclic lactones, eprinomectin has the potential to adversely affect non-target organisms. Following treatment, excretion of potentially toxic levels of eprinomectin may take place over a period of several weeks. Faeces containing eprinomectin excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms which may impact on the dung degradation.
Marketing Authorisation Holder (if different from distributor)
n/a
Marketing Authorisation Number
Vm 08327/4282
Significant changes
Date of the first authorisation or date of renewal
15 December 2016
Date of revision of the text
August 2019
Any other information
n/a
Legal category
Legal category: POM-V
GTIN
GTIN description:Eprinex Multi 5 L x 1
GTIN:03661103056355
GTIN description:Eprinex Multi 2.5 L x 1
GTIN:03661103056331
GTIN description:Eprinex Multi 1 L x 1
GTIN:03661103056348
GTIN description:Eprinex Multi 0.25 L x 1
GTIN:03661103056362