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Clinical particulars
Target species
Cattle (newborn calves).
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 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.
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.
Special warnings
None.
Special precautions for use
Special precautions for use in animals
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.
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, 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.
Adverse reactions (frequency and seriousness)
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:
- Very common (more than 1 in 10 animals treated displaying adverse reactions)
- 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).
Use during pregnancy, lactation or lay
Not applicable.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
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.
4 ml pump
1Choose the dip tube designed for the height of the bottle (the shorter one for the 490 ml bottle and the longer one for the 980 ml bottle) and insert it into the free hole located in the base of the pump cap.
2Remove the cap of the bottle and protective seal from the bottle and screw the pump on.
3Remove the protector cap from the tip of the nozzle of the pump.
4Prime the pump by pressing the trigger gently, until a drop appears at the tip of the nozzle.
5Restrain the calf and insert the nozzle of the metering pump into its mouth
6Pull the trigger of the metering pump completely for release of a dose that equals 4 ml of solution.Pull two or three times, respectively, for administration of the desired volume (8 ml for calves weighing more than 35 kg but less than or equal to 45 kg and 12 ml for calves weighing more than 45 kg but less than or equal to 60 kg). For lighter or heavier animals, a precise calculation should be performed (2 ml/10 kg bw).
7Continue using until the bottle is empty. If product remains in the bottle, leave the pump attacheduntil further use.
8Always replace the cap on the tip of the nozzle after use.
9Always replace the bottle in the box.
4 to 12 ml pump
10Choose the dip tube designed for the height of the bottle (the shorter one for the 490 ml bottle andthe longer one for the 980 ml bottle) and insert it into the free hole located in the base of the pump cap.
11Remove the cap of the bottle and protective seal from the bottle and screw the pump on.
12Remove the protector cap from the tip of the nozzle of the pump.
13To prime the pump, turn the dosage ring and select 60 kg (12 ml).
14Press the trigger gradually with the cannula pointed up, until a drop appears at the tip of the nozzle.
15Turn the ring, in order to select the weight of the calf to be treated.
16Restrain the calf and insert the nozzle of the metering pump into its mouth.
17Pull the trigger of the metering pump completely for release of the adequate dose.
18Continue using until the bottle is empty. If product remains in the bottle, leave the pump attached until further use.
19Always replace the cap on the tip of the nozzle after use.
20Always replace the bottle in the box.
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.
Withdrawal period(s)
Meat and offal: 13 days.