SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Halofusol 0.5 mg/ml oral solution for calves

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substances:

Halofuginone 0.50 mg

(equivalent to 0.6086 mg of halofuginone lactate) Excipients:

Qualitative composition of excipients and other constituents	Quantitative composition if that information is essential for proper administration of the veterinary medicinal product
Benzoic acid (E 210)	1.00 mg
Tartrazine (E 102)	0.03 mg
Lactic Acid (E 270)
Purified water

Clear yellow solution.

3. CLINICAL INFORMATION

3.1 Target species

Cattle (newborn calves).

3.2 Indications for use for each target species

•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 life.

•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.

3.3 Contraindications

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.

3.4 Special warnings

None.

3.5 Special precautions for use

Special precautions for safe use in the target species:

Administer after colostrum feeding, or after milk or milk replacer feeding only, using either the metering pump included or any 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.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

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

Repetitive contact with the veterinary medicinal product may lead to skin allergies. Avoid skin eye and mucosal contact with the veterinary medicinal product. Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product.

In case of accidental spillage onto skin or eye contact wash the exposed area thoroughly with clean water. If an eye irritation persists, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

3.6 Adverse events

Cattle (newborn calves):

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

Diarrhoea1

¹ Increase in the level.

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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay

Not applicable.

3.8 Interaction with other medicinal products and other forms of interaction

None known.

3.9 Administration routes and dosage

Oral use.

In calves after feeding.

The dosage is: 100 µg of halofuginone base / kg bw / once a day for 7 consecutive days, i.e. 4 ml of the veterinary medicinal product / 20 kg bw / once a day for 7 consecutive days.

However, in order to make the veterinary medicinal product treatment easier, a simplified dosage scheme is proposed:

• 35 kg < calves ≤ 45 kg: 8 ml of the veterinary medicinal product once a day during 7 consecutive days

• 45 kg < calves < 60 kg: 12 ml of the veterinary medicinal product once a day during 7 consecutive days

For smaller or higher weights, a precise calculation should be performed (4 ml/20 kg). To ensure a correct dosage, body weight should be determined as accurately as possible.

To ensure a correct dosage, the use of either the metering pump included or any appropriate device for oral administration is necessary. The use of suitably calibrated measuring equipment is recommended. In case of using the metering pump included, it should not be used upside down, and has to be proceed as follows:

1) Screw the metering pump on the bottle.

2) Remove the protector cap from the nozzle.

3) If the metering pump is used for the first time (or hasn’t been used for a few days), carefully pump till a drop of solution is formed on top of the nozzle.

4) Restrain the calf and insert the nozzle of the metering pump into the calves mouth.

5) Pull the trigger of the metering pump completely for release of a dose that equals 4 ml of solution. Pull twice or three times, respectively, for administration of the desired volume (8 ml for calves of 35 – 45 kg and 12 ml for calves of 45 – 60 kg, respectively).

6) Unscrew the metering pump on the bottle.

7) Close the bottle with the screw cap.

8) Pull twice or three times in order to empty the remained product in the metering pump.

9) Put the protector cap back on the nozzle.

The consecutive treatment should be done 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.

3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)

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.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable

3.12 Withdrawal periods

Meat and offal: 13 days

4. PHARMACOLOGICAL INFORMATION

4.1 ATCvet code: QP51AX08

4.2 Pharmacodynamics

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 activity 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/ml and IC90 of 4.5 µg/ml respectively.

4.3 Pharmacokinetics

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 single oral administration.

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

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

5.2 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 30 months. Shelf life after first opening the immediate packaging: 6 months.

5.3 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

5.4 Nature and composition of immediate packaging

White high-density polyethylene bottle sealed with a high-density polyethylene screw cap with induction disk. The medicinal product can be supplied with or without a metering pump that consists of several components made out of high, low and linear low-density polyethylene, polypropylene, stainless steel and silicone.

Package sizes:

Bottle of 250 ml.

Cardboard box containing 1 bottle of 250 ml with a 4 ml metering pump.

Cardboard box containing 1 bottle of 250 ml. Bottle of 500 ml.

Cardboard box containing 1 bottle of 500 ml with a 4 ml metering pump.

Cardboard box containing 1 bottle of 500 ml.

Bottle of 1000 ml.

Cardboard box containing 1 bottle of 1000 ml with a 4 ml metering pump. Cardboard box containing 1 bottle of 1000 ml.

Not all packs sizes may be marketed.

5.5 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater or household waste.

The veterinary medicinal product should not enter water courses as halofuginone may be dangerous for fish and other aquatic organisms.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Laboratorios Karizoo S.A

7. MARKETING AUTHORISATION NUMBER

Vm 31223/4009

8. DATE OF FIRST AUTHORISATION

23 December 2020

9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

April 2026

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 26 May 2026