Halofusol
Active substance
ATC code
Species
Cattle (newborn calves).
Indications
In new born 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 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.
Dose to be administered and administration route
For 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 product / 20 kg bw / once a day for 7 consecutive days.
However, in order to make the product treatment easier, a simplified dosage scheme is proposed:
• 35 kg < calves ≤ 45 kg: 8 ml of the product once a day during 7 consecutive days
• 45 kg < calves < 60 kg: 12 ml of the 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, the use of either the metering pump included or any appropriate device for oral administration is necessary. 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.
Adverse reactions
In very rare cases, an increase in the level of diarrhoea has been observed in treated animals.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
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 substance:
Halofuginone 0.50 mg
Equivalent to 0.6086 mg of halofuginone lactate Excipients:
|
Benzoic acid (E 210) |
1.00 mg |
|
Tartrazine (E 102) |
0.03 mg |
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution.
Clear yellow solution
4. CLINICAL PARTICULARS
4.1 Target species
Cattle (newborn calves).
4.2 Indications for use, specifying the target species
In new born 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 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.
4.3 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 known cases of hypersensitivity to the active substance or to any of the excipients.
4.4 Special warnings for each target species
None.
4.5 Special precautions for use
Special precautions for use in animals
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 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 and eye contact with the product. In case of skin and eye contact wash the exposed area thoroughly with clean water. If an eye irritation persists, seek medical advice.
Wear protective gloves while handling the product. Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
In very rare cases, an increase in the level of diarrhoea has been observed in treated animals.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
4.7 Use during pregnancy, lactation or lay
Not applicable.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
4.9 Amounts to be administered and administration route
For 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 product / 20 kg bw / once a day for 7 consecutive days.
However, in order to make the product treatment easier, a simplified dosage scheme is proposed:
• 35 kg < calves ≤ 45 kg: 8 ml of the product once a day during 7 consecutive days
• 45 kg < calves < 60 kg: 12 ml of the 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, the use of either the metering pump included or any appropriate device for oral administration is necessary. 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
4.11 Withdrawal period(s)
Meat and offal: 13 days
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Other antiprotozoal agents, halofuginone ATC vet code: QP51AX08.
5.1 Pharmacodynamic properties
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.
5.2 Pharmacokinetic particulars
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.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzoic acid (E 210)
Tartrazine (E 102)
Lactic Acid (E 270)
Purified water
6.2 Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
6.3 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
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 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.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
The product should not enter water courses as this may be dangerous for fish and other aquatic organisms. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Laboratorios Karizoo S.A
Polígono Industrial La Borda
Mas Pujades 11-12
08140 Caldes de Montbui
Barcelona
Spain
8. MARKETING AUTHORISATION NUMBER
Vm 31223/4009
9. DATE OF FIRST AUTHORISATION
23 December 2020
10 DATE OF REVISION OF THE TEXT
December 2020
Approved: 23 December 2020
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Halofusol
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