Cattle

Treatment of mixed trematode (fluke) and nematode infections and certain arthropod infestations caused by moxidectin and triclabendazole sensitive strains of:

Parasite	Adult stage		Inhibited stages
NEMATODES		L4
Gastro-intestinal nematodes:
Haemonchus placei	X	X
Ostertagia ostertagi	X	X	X
Trichostrongylus axei	X	X
Nematodirus helvetianus	X	X
Cooperia oncophora	X	X
Cooperia punctata	X
Oesophagostomum radiatum	X
Bunostomum phlebotomum	X
Respiratory tract nematode:
Dictyocaulus viviparus	X
TREMATODES
Liver fluke:		6 – 8 weeks immatures
Fasciola hepatica	X	X
ECTOPARASITES
Linognathus vituli	X
Bovicola bovis	X
Solenopotes capillatus	X

The product has a persistent effect in preventing re-infection by Ostertagia ostertagi and by Dictyocaulus viviparus for 5 weeks after a single dose.

Do not use in cases of known hypersensitivity to the active substances or to any of the excipient(s).

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 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 moxidectin has been reported mainly in Cooperia oncophora in some European countries.Resistance to other MLs in some strains of Cooperia spp. can imply concurrent resistance to Moxidectin. Resistance to triclabendazole has been reported in Fasciola hepatica in cattle in some European countries. Triclabendazole resistant F. hepatica hosted in sheep can be transferred to cattle grazing the same pasture. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of parasites, local history of treatments and recommendations on how to limit further selection for resistance to anthelmintics.

This veterinary medicinal product should not be used for the treatment of single infections.

It has been shown that rainfall immediately before or within 2 hours after treatment will not affect the efficacy of the product.

This product has been formulated specifically for pour-on administration for cattle and must not be given by any other route of administration or to any other species.

People with known hypersensitivity to the active substance should avoid contact with the veterinary medicinal product. The veterinary medicinal product may cause skin and eye irritation. Avoid direct contact with skin and eyes.

Personal protective equipment consisting of gloves, protective work clothing and safety glasses should be worn when handling the veterinary medicinal product. In case of accidental splash onto the eye or the skin, wash with plenty of clean, running water immediately.

If irritation persists, seek medical advice immediately and show the package leaflet or the label to the physician.

Do not smoke, drink or eat while handling the product. Wash hands after use.

Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance; therefore, exposure of the environment to moxidectin must be limited to the extent possible. Treatments should be administered only when necessary and should be based on faecal egg counts or evaluation of the risk of infestation at the animal and/or herd level.

Like other macrocyclic lactones, moxidectin has the potential to adversely affect non-target organisms:

∙ Faeces containing moxidectin excreted onto pasture by treated animals may temporarily reduce the abundance of dung feeding organisms. Following treatment of cattle with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period more than 2 weeks and may decrease dung fly abundance during that period. It has been established in laboratory tests that moxidectin may temporarily affect dung beetle reproduction; however, field studies indicate no-long term effects. Nevertheless, in case of repeated treatments with moxidectin (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.

∙ Moxidectin is inherently toxic to aquatic organisms including fish. The product should be used only according to the label instructions. Based on the excretion profile of moxidectin when administered as the pour-on formulation, treated animals should not have access to watercourses during the first week after treatment.

Cattle:

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Application site irritation, Digestive tract disorders (such as diarrhoea), Hypersensitivity reaction, Neurological disorders (such as ataxia)

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 its local representative or the national competent authority via the national reporting system. See also the section “Contact Details” of the package leaflet.

Pregnancy and lactation:

The product is safe for use in pregnant and lactating animals.

None known.

External use only.

0.5 mg moxidectin/kg body weight and 20 mg triclabendazole/kg body weight (equivalent to 1 ml of solution for 10 kg) and as a single topical application.

To be administered directly to the hair and skin along the midline of the back of the animal from the withers to the tail head.

Apply to clean healthy skin.

To ensure a correct dosage, body weight 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- or overdosing.

Shake before use.

Step 1: Remove screw cap from dispensing chamber only. Remove foil seal.

Step 2: Gently squeeze the bottle to fill the measuring chamber with the required amount of liquid.

Step 3: Pour the measured volume of fluid from the chamber onto the animal as directed. Repeat steps 2 and 3 for subsequent animals

Step 4: Reapply the screw cap to the dispensing chamber after use.

Connect the pour-on applicator to the backpack as follows:

Attach the open end of the draw-off tubing to the cap with the stem.

Replace shipping cap with the cap that has the draw-off tubing. Tighten the draw-off cap.

Gently prime the pour-on applicator, checking for leaks.

Follow manufacturer’s directions for correct use and care of equipment.

Signs of overdoses have not been seen at 5 times the recommended dose. However, if they do occur they should be consistent with the mode of action of moxidectin and would be manifested as transient salivation, depression, drowsiness and ataxia. Treatment is not generally necessary and recovery is generally complete within 24 to 48 hours. There is no specific antidote.

Not applicable.

Meat and offal: 143 days.

Milk: Do not use in cattle of any age intended to produce milk for human consumption.

Due to the significant likelihood of cross-contamination of non-treated animals with this product due to grooming (licking), treated animals should be housed separately from non-treated animals throughout the withdrawal period. Non-compliance with this recommendation may lead to residues violations in non-treated animals.