Cryptisel 0.5 mg/ml Oral Solution for Calves

Composition

Each ml contains:

Active substances:

Halofuginone 0.50 mg

Equivalent to 0.6086 mg of Halofuginone lactate

Excipients:

Clear yellow solution.

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Pharmacological properties

4.1 ATCvet code: QP51BX01

4.2 Pharmacodynamics

The active substance, halofuginone, is an antiprotozoal agent of the quinazolinone derivatives group (nitrogenous polyheterocycles). Halofuginone lactate 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 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. Halofuginone 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.

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Target species

Cattle (newborn calves).

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Indications

• 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.

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Dosage

Oral use.

To be administered after feeding.

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

The consecutive treatment should be done at the same time each day.

Once the first calf has been treated, all the forthcoming newborn 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 an appropriate device for oral administration (e.g. a syringe) is necessary.

Bottle with a pump: To ensure a correct dosage, an appropriate metering pump is included.

1) Insert the suction pipe into the free hole located in the base of the pump cap.

2) Remove the cap of the bottle and screw the pump on.

3) Remove the protector cap from the tip of the nozzle of the pump.

4) If the metering pump is used for the first time (or has not been used for a few days), carefully pump until a drop of solution is formed on top of the nozzle.

5) Restrain the calf and insert the nozzle of the metering pump into its mouth.

6) Pull the trigger of the metering pump completely for release of a dose that equals 4 ml of solution.

• For animals weighing from more than 35 kg but less than or equal to 45 kg, pull two times (equivalent to 8 ml)

• For animals weighing from more than 45 kg but less than or equal to 60 kg, pull three times (equivalent to 12 ml)

7) Unscrew the metering pump on the bottle.

8) Close the bottle with the screw cap.

9) Pull twice or three times in order to empty the remaining product in the metering pump.

10) Put the protector cap back on the nozzle.

The metering pump should not be used upside down.

To ensure a correct dosage, body weight should be determined as accurately as possible.

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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.

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Adverse reactions

Cattle (newborn calves):

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

Diarrhoea1

1 an increase has been observed.

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, its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Administer after colostrum feeding, or after milk or milk replacer feeding only, using an appropriate device for oral administration.

For treatment of anorexic calves, the veterinary medicinal 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 or 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 skin, eye and mucosa contact wash the exposed area thoroughly with clean water. If eye irritation persists, seek medical advice 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.

3.11 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.

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Use during pregnancy, lactation or lay

Not applicable.

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Interactions

None known.

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Overdose

As clinical signs of toxicity may occur at twice the therapeutic dose, it is necessary to apply the recommended dosage strictly. Clinical signs 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.

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Special warnings

None.

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Withdrawal period

Meat and offal: 13 days.

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Incompatibilities

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

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Immediate packaging

Bottle of 300 ml: High-density polyethylene (HDPE) bottle sealed with a polyethylene terephthalate (PET) foil and closed with a polypropylene screw cap.

Bottles of 500 ml and 1000 ml: High-density polyethylene (HDPE) bottles sealed with a polyethylene (PE) foil and closed with a HDPE screw cap.

The veterinary medicinal product can be supplied with or without a 4 ml metering pump, made of low and linear low-density polyethylene, polypropylene, stainless steel and silicone with a low-density polyethylene (LDPE) suction pipe.

Package sizes:

Cardboard box with 1 bottle of 300 ml (containing 290 ml of solution) with a 4 ml metering pump

Cardboard box with 1 bottle of 300 ml (containing 290 ml of solution)

Cardboard box with 1 bottle of 500 ml (containing 490 ml of solution) with a 4 ml metering pump

Cardboard box with 1 bottle of 500 ml (containing 490 ml of solution)

Cardboard box with 1 bottle of 1000 ml (containing 980 ml of solution) with a 4 ml metering pump

Cardboard box with 1 bottle of 1000 ml (containing 980 ml of solution)

Not all pack sizes may be marketed.

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Storage

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

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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.

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Disposal of unused product

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.

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Additional information

Vm 36547/5012

Vm 36547/3012

8 DATE OF FIRST AUTHORISATION

19 November 2020

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

August 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.

Approved 11 September 2026

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Registration holder

Industrial Veterinaria SA

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