Patient leaflet - Halagon
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
HALAGON 0.5 mg/ml oral solution for calves
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing Authorisation Holder :
EMDOKA bvba
John Lijsenstraat 16
B-2321 Hoogstraten
Belgium
Manufacturer responsible for batch release :
Divasa-Farmavic, S.A.
Ctra. Sant Hipolit, Km. 71
08503 Gurb-Vic, Barcelona
Spain
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
HALAGON 0.5 mg/ml oral solution for calves
halofuginone (as lactate salt)
3.
STATEMENT OF ACTIVE SUBSTANCE (S) AND OTHER INGREDIENTS
Each ml contains:
Active substance:
Halofuginone (as lactate salt) 0.50 mg
Equivalent to 0.6086 mg of halofuginone lactate
Excipients:
Benzoic acid (E210) 1 mg
Tartrazine (E102) 0.03 mg
Clear yellow oral solution.
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4. INDICATION(S)
In new-born calves:
- Prevention of diarrhoea due to diagnosed Cryptosporidium parvum infection, 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 infection.
Administration should start within 24 hours after the onset of diarrhoea.
In both cases, the reduction of oocysts excretion has been demonstrated.
5.
CONTRAINDICATIONS
Do not use on an empty stomach.
Do not use in case 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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6. ADVERSE REACTIONS
An increase in the level of diarrhoea has been observed in very rare cases in treated animals.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Cattle (newborn calves)
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
For oral use in calves after feeding.
The dosage is: 100 ^g of halofuginone / kg body weight (bw) / once a day for 7 consecutive days, i.e. 4 ml of HALAGON / 20 kg bw / once a day for 7 consecutive days.
However, in order to make the HALAGON treatment easier, a simplified dosage scheme is proposed:
- 35 kg < calves < 45 kg: 8 ml of HALAGON once a day during 7 consecutive days
- 45 kg < calves < 60 kg: 12 ml of HALAGON 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, an appropriate doser for administration of ‘HALAGON’ is included.
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.
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9. ADVICE ON CORRECT ADMINISTRATION
To ensure a correct dosage, an appropriate doser for administration of ‘HALAGON’ is included.
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1) Screw the metering pump on the bottle.
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2) Remove the protector cap from the nozzle.
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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.
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4) Restrain the calf and insert the nozzle of the metering pump into the calves mouth.
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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).
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6) Put the protector cap back on the nozzle.
10.
WITHDRAWAL PERIOD(S)
Meat and offal: 13 days.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Keep the bottle in the outer carton in order to protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Shelf-life after first opening the immediate packaging: 6 months.
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12. SPECIAL WARNING(S)
Special precautions for use in animals:
Administer after colostrum feeding, or after milk or milk replacer feeding only. An appropriate device for oral administration is included. 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.
Pregnancy and lactation:
Not applicable.
Overdose (symptoms, emergency procedures, 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.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY