Merck Animal Health

Halofuginone Solution (as Halofuginone Lactate)

DIN 02387980

For Veterinary Use Only

DESCRIPTION: Each mL of HALOCUR contains:

MEDICINAL INGREDIENTS: 0.5 mg halofuginone (as halofuginone lactate); NON-MEDICINAL INGREDIENTS: 0.03 mg tartrazine, 10.0 mg of lactic acid and water qs to 1 mL.

PRESERVATIVES: 1.0 mg benzoic acid.

INDICATIONS: HALOCUR is an anti-protozoal solution indicated as an aid in reducing clinical signs of cryptosporidiosis caused by Cryptosporidium parvum in new born calves, when administered orally (after colostrum or milk/milk replacer feeding) for the first 7 days of life at a dosage of 100 µg of halofuginone base per kg of body weight.

DOSAGE AND ADMINISTRATION: For oral use in newborn calves after feeding. The dosage is: 2 mL HALOCUR / 10 kg bw (i.e. 100 µg halofuginone lactate base/kg bw) once a day for 7 consecutive days. The following table shows the appropriate daily dose for various birth weights of calves:

To ensure correct dosing, the use of either a syringe or any appropriate device for oral administration is necessary. The consecutive treatments should be done at the same time each day following feeding. Once the first calf has been treated, all the subsequent new-born calves should be systematically treated as long as the risk for infection with C. parvum, as assessed by a veterinarian, persists.

CONTRA-INDICATONS: Do not use on an empty stomach. For calves that are ill, scouring, dehydrated or off-feed, HALOCUR treatment should not be initiated (at one day of age).

CAUTIONS: Administer after colostrum feeding or after milk or milk replacer feeding only, using either a syringe or any appropriate device for oral administration.

For calves that are ill, scouring, dehydrated or off-feed, HALOCUR treatment should be discontinued. The animals should receive enough colostrum according to good management practice.

No studies have been carried out to determine the effect of HALOCUR on reproductive function in cattle, although there were no adverse effects found in reproductive function studies in laboratory species of animals.

WARNINGS:

• Treated calves must not be slaughtered for use in food for at least 20 days after the latest treatment with this drug.

• Do not use in animals producing milk for human consumption.

• Repetitive contact with the product may lead to skin allergies.

• Wear protective gloves while handling the product.

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

• Wash hands after use.

• HALOCUR should not enter the watercourses, as this may be dangerous for fish and other aquatic organisms. Any unused drug product or waste materials derived from such drug products should be disposed of in accordance with the local requirements.

• Keep out of reach of children.

ADVERSE REACTIONS: As symptoms of toxicity may occur at 2 times the therapeutic dose, it is necessary to strictly apply the recommended dosage. Symptoms of toxicity include diarrhea, 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. In rare cases, an increase in the level of diarrhea has been observed in treated animals. In very rare cases, lethargy and anorexia may occur.

Because of the complex nature of neonatal calf diarrhea the use of HALOCUR should be combined with good hygiene and colostrum management.

PHARMACOLOGY: The active substance, Halofuginone, is an antiprotozoal agent of the quinazolinone derivatives group (nitrogenous polyheterocycles). Halofuginone lactate (RU 38788) is a salt whose antiprotozoal properties and efficacy against Cryptosporidium parvum have been demonstrated either in in vitro conditions or 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 (sporozoite, merozoite). The concentration to inhibit respectively 50% and 90% of the parasites in an in vitro test system is IC₅₀ < 0.1 µg/mL and IC₉₀ of 4.5 µg/mL. The bioavailability of the drug in the calf following single oral administration is about 80%.

The time necessary to obtain the maximum concentration T_max is 11 hours. The maximum concentration in plasma C_max 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 a single oral administration.

STORAGE: Store at room temperature (15°-25°C) in a dry place. Do not use the opened product after 6 months. Avoid introduction of contamination.

HOW SUPPLIED: HALOCUR is available in high-density polyethylene bottles containing 490 mL or 980 mL of the oral solution.

Intervet Canada Corp., subsidiary of Merck & Co., Inc., 16750, route Transcanadienne, Kirkland, QC H9H 4M7

1 866 683-7838

Version 04AUG2017

CPN: 1208256.3