Active substance:

Halofuginone (as lactate salt) 0.50 mg per ml

Excipients:

Benzoic acid (E 210) 1.00 mg

Tartrazine (E 102) 0.03 mg

Water, Purified

Oral solution. Clear yellow solution.

Cattle (newborn calves).

In newborn calves:

- Prevention of diarrhoea due to diagnosed Cryptosporidium parvum, in farms with history of cryptosporidiosis.

Administration should start in the first 24 to 48 hours of age.

- Reduction of diarrhoea due to diagnosed Cryptosporidium parvum.

Administration should start within 24 hours after the onset of diarrhoea.

In both cases, the reduction of oocysts excretion has been demonstrated.

Do not use on an empty stomach.

Do not use in cases of diarrhoea established for more than 24 hours and in weak animals.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

None.

Administer after colostrum feeding, or after milk or milk replacer feeding only, using an appropriate device for oral administration. Do not use on an empty stomach. For treatment of anorexic calves, the product should be administered in half a litre of an electrolyte solution. The animals should receive enough colostrum according to good breeding practice.

People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution.

Repetitive contact with the product may lead to skin allergies.

Avoid skin, eye or mucosal contact with the product.

Wear protective gloves while handling the product.

In case of skin and eye contact wash the exposed area thoroughly with clean water. If eye irritation persists, seek medical advice.

Wash hands after use.

An increase in the level of diarrhoea has been observed in rare cases, in treated animals.

The frequency of adverse reactions is defined using the following convention:

Not applicable.

None known.

For oral use in calves after feeding.

The dosage is: 100 μg of halofuginone / kg bw, once a day for 7 consecutive days; i.e. 2 ml of Kriptazen / 10 kg bw, once a day for 7 consecutive days.

The consecutive treatment should be administered at the same time each day. Once the first calf has been treated, all the forthcoming new-born calves must be systematically treated as long as the risk for diarrhoea due to C. parvum persists.

Bottle without a pump: To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary.

Bottle with a pump: To ensure a correct dosage, the most appropriate metering pump should be selected, depending on the weight of the animals to be treated. In cases where the dosing pump is unsuitable for the weight of animals to be treated, either a syringe or any other appropriate device can be used.

As symptoms of toxicity may occur at twice the therapeutic dose, it is necessary to apply the recommended dosage strictly. Symptoms of toxicity include diarrhoea, visible blood in faeces, decline in milk consumption, dehydration, apathy and prostration. Should clinical signs of overdosing occur, the treatment must be stopped immediately and the animal fed unmedicated milk or milk replacer. Rehydration may be necessary.

Meat and offal: 13 days.

Pharmacotherapeutic group: Other antiprotozoal agents, halofuginone.

ATCvet code: QP51AX08.

The active substance, halofuginone, is an antiprotozoal agent of the quinazolinone derivatives group (nitrogenous polyheterocycles). Halofuginone lactate is a salt whose antiprotozoal properties and efficacy against Cryptosporidium parvum have been demonstrated both in in vitro conditions and in artificial and natural infections. The compound has a cryptosporidiostatic effect on Cryptosporidium parvum. It is mainly active on the free stages of the parasite (sporozoïte, merozoïte). The concentrations to inhibit 50% and 90% of the parasites, in an in vitro test system, are IC50 < 0.1 μg/mland IC90 of 4.5 μg/ml, respectively.

The bioavailability of the drug in the calf following single oral administration is about 80%. The time necessary to obtain the maximum concentration Tmax is 11 hours. The maximum concentration in plasma Cmax is 4 ng/ml. The apparent volume of distribution is 10 l/kg. The plasmatic concentrations of halofuginone after repeated oral administrations are comparable to the pharmacokinetic pattern after single oral treatment. Unchanged halofuginone is the major component in the tissues. Highest values have been found in the liver and the kidney. The product is mainly excreted in the urine. The terminal elimination half-life is 11.7 hours after IV administration and 30.84 hours after single oral administration.

Benzoic acid (E 210), Lactic acid (E 270), Tartrazine (E 102), Water, Purified

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf-life after first opening the immediate packaging: 6 months.

Keep the bottle in the outer carton in order to protect from light.

Store upright in the original packaging.

Cardboard box containing one 500 ml bottle (high-density polyethylene) containing 490 ml of solution or one 1000 ml bottle containing 980 ml of solution, sealed with a high density polyethylene cap, with or without a metering pump, with two different lengths dip tubes (22 and 24 cm) made of ethylene-vinyl acetate.

Each package also contains a plastic metering pump delivering 4 ml volumes and two dip tubes (one to fit a 500 ml bottle and one to fit a 1000 ml bottle).

Each package also contains a plastic metering pump delivering 4 to 12 ml and two dip tubes (one to fit a 500 ml bottle and one to fit a 1000 ml bottle).

Not all pack sizes may be marketed.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

The product should not enter watercourses as this may be dangerous for fish and other aquatic organisms.

VIRBAC, 1ère avenue – 2065 m – LID, 06516 Carros, France

VM 05653/5012

February 2019

August 2023