EPRINEX MULTI 5MG/ML 5L

EPRINEX MULTI 5MG/ML 5L 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 animals with known hypersensitivity to eprinomectin 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.
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 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.
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 too frequent and repeated use of eprinomectin (and products of the same anthelmintic class) in animals. The risk to aquatic ecosystems will be further reduced by keeping treated animals away from water bodies for two to five weeks after treatment.

Adverse Reactions
No undesirable effects have been identified when the product is used at the recommended dose rate.

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 EPRINEX MULTI 5MG/ML 5L EPRINEX MULTI 5MG/ML 5L EPRINEX MULTI 5MG/ML 5L
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