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Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.
Introduction 
Company name: Novartis Animal Health UK Ltd
Address: Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
Telephone: 01276 694402
Fax: 01276 694403
Presentation
Denagard 12.5% Oral Solution is an aqueous concentration solution containing 125 mg tiamulin hydrogen fumarate per ml and also contains methyparahydroxybenzoate and propylparahydroxybenzoate as preservatives.
Uses Actions
The following organisms show sensitivity to tiamulin hydrogen fumarate in vitro:
Brachyspira: Brachyspira hyodysenteriae, Brachyspira pilosicoli
Mycoplasmas: Mycoplasma hyopneumoniae, M.hyorhinis, M. hyosynoviae, Ureaplasma spp.M. gallisepticum, M. synoviae and M. meleagridis
Gram-positive: Staphylococcus spp., Streptococcus spp., Arcanobacterium pyogenes
Gram-negative: Pasteurella spp., Klebsiella pneumoniae, Actinobacillus (Haemophilus) spp., Flusobacterium necrophorum, Bacteroides spp., Campylobacter coli, Lawsonia intracellularis
Indications
Pigs:For the treatment, prevention and control of swine dysentery caused by Brachyspira hyodysenteriae and complicated by Fusobacterium spp. and Bacteroides spp.
Chickens: For the reduction in the severity of disease caused by mycoplasmas.
Turkeys: For the reduction in the severity of disease caused by mycoplasmas.
Dosage and administration
Pigs: The dosage is 8.8 mg of the active substance per kg bodyweight daily, (equivalent to 10 ml Denagard 12.5% Oral Solution per 142 kg bodyweight) administered in the drinking water of pigs for 3 to 5 days, depending on the severity of the infection and/or the duration of the disease.
The contents of each 1 litre bottle will treat 188 pigs of 25 kg bodyweight for three days or 114 pigs of 25 kg bodyweight for 5 days.
To ensure an intake of 8.8 mg/kg daily, Denagard 12.5% Oral Solution may be administered in one of two ways.
1.Denagard 12.5% Oral Solution may be administered in approximately one half of the daily water requirements, to ensure consumption of the correct dose. Unmedicated water should be provided each day after the medicated water has been consumed. The dosage rate, calculated on a liveweight basis, is equivalent to 10 ml solution per 142 kg bodyweight
2.Denagard 12.5% Oral Solution may be administered continuously at a level of 60 ppm of active substance in the drinking water, as the only source of drinking water. The daily requirement should be added to the drinking water at the rate of 9.6 ml solution per 20 litres (4.5 gallons) of water.
Where a water medicator is used the appropriate stock solution should be made up according to the makers instructions.If there is no response to treatment within 5 days, the diagnosis should be re-established.
Chickens: The dosage for chickens is 25 mg of active substance per kg bodyweight (equivalent to 100 ml of product per 500 kg bodyweight). Tiamulin should be administered continuously at a level of 0.025% (250 ppm) in drinking water (2 ml product per litre of water) for 3 – 5 days and will provide approximately the following daily dosage of tiamulin depending on the age of the bird:
Day old chick:125 – 150 mg/kg bodyweight
4 week old broiler:30 – 50 mg/kg bodyweight
10 week old pullet:30 – 45 mg/kg bodyweight
Layer:25 mg/kg bodyweight
Turkeys: The dosage for turkeys is 25 mg of active substance per kg bodyweight (equivalent to 100 ml of product per 500 kg bodyweight). Tiamulin should be administered continuously at a level of 0.025% (250 ppm) tiamulin in the drinking water (2 ml product per litre of water) for 5 days and will provide approximately the following daily dosage of tiamulin depending on the age of the bird:
1 week old poult:70 mg/kg bodyweight
4 week old poult:50 mg/kg bodyweight
8 week old poult:20 – 30 mg/kg bodyweight
20 week old poult:25 mg/kg bodyweight
Monitor water intake at frequent intervals during medication.
Fresh solutions of tiamulin-medicated drinking water should be made up each day.
Contra-indications, warnings, etc Warnings
Animals and birds must not be slaughtered for human consumption during treatment.
Pigs may be slaughtered for human consumption only after 2 days from the last treatment.
Chickens may be slaughtered for human consumption only after 2 days from the last treatment.
Eggs: zero days.
Turkeys may be slaughtered for human consumption only after 5 days from the last treatment.
Contra-indications
Do not use in animals hypersensitive to the active ingredient.
Animals and birds should not receive products containing monensin, narasin or salinomycin during or for at least seven days before or after treatment. Severe growth depression or death may result.
Concomitant use of tiamulin and the ionophore anticoccidial maduramicin may lead to a mild to moderate growth depression in chickens. The situation is transient and recovery normally occurs within 3 – 5 days following withdrawal of tiamulin treatment. This does not seem to occur with the ionophores lasalocid or semduramicin.
In order to avoid interactions between tiamulin and the incompatible ionophores monensin, narasin and salinomycin, the feed mill supplying the feed should be notified that tiamulin will be used and that these products should not be included in the feed or contaminate the feed.
The feed should be tested for the ionophores prior to use if there is any suspicion that contamination of the feed might occur. If an interaction does occur, stop tiamulin water medication immediately and replace with fresh water. Remove contaminated feed as soon as possible and replace with feed not containing the tiamulin-incompatible ionophores.
Operator warnings
When mixing, direct contact with the skin and eyes should be avoided by wearing impermeable rubber gloves and safety glasses. In case of accidental eye contact, irrigate the eyes thoroughly with clean running water immediately. Seek medical advice if irritation persists. Contaminated clothing should be removed and any splashes on the skin should be washed off immediately. Wash hands after use.
Pregnancy and lactation
Denagard can be used in pregnant and lactating pigs.
Tiamulin may be used in laying and breeding birds as it has been shown to have no adverse effects on egg production, fertility and hatchability in chickens and turkeys.
Precautions
For use in the drinking water of pigs, chickens and turkeys only.
If there is no response to treatment within five days, the diagnosis should be re-established.
Severely affected pigs that do not drink should be treated with Denagard 200 Solution for Injection.
On rare occasions erythema or mild oedema of the skin may occur in pigs following the use of tiamulin hydrogen fumarate.
Water intake may be depressed during the administration of tiamulin to birds. It appears to be concentration dependent with 0.025% (250 ppm) tiamulin reducing intake by approximately 15%. It does not appear to have any adverse effect on overall performance of the birds or efficacy of the product.
There is a relatively high therapeutic index with tiamulin and the likelihood of an overdosage is considered remote, especially as water intake and hence tiamulin intake is reduced if abnormally high concentrations are given. The LD5 for chickens is 1290mg/kg bodyweight and for turkeys 840mg/kg bodyweight.
The clinical signs of toxicity in chickens are: vocalization, clonic cramps and lying in a lateral position. Symptoms in turkeys are: clonic cramps, lateral or dorsal position, salivation and ptosis.
If signs of intoxication do occur, promptly remove the medicated water and replace with fresh water.
For animal treatment only.
Keep out of the reach of children.
Pharmaceutical precautions
Do not store above 25°C. Fresh medicated water must be prepared every 24 hours. Watering equipment should be thoroughly cleaned prior to addition of Denagard 12.5% Oral Solution.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Legal category
POM-V
Packaging Quantities
1 litre dispensing packs
Further information
Nil.
Marketing authorisation number
Vm 12501/4080.
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