This Product cannot be purchased without a prescription
Denagard is used to treat Mycoplasma disease in chickens and turkeys and swine dysentery in pigs.
Instructions for Use:
Denagard 12.5% w/v Concentrate for Oral Solution
Presentation
Denagard 12.5% Concentrate for Oral Solution is a pale yellow aqueous concentration solution containing 125 mg tiamulin hydrogen fumarate per ml and which contains methy parahydroxybenzoate and propyl parahydroxybenzoate as preservatives, amongst others.
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., Fusobacterium 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% Concentrate for 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% Concentrate for Oral Solution may be administered in one of two ways.
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
Withdrawal Periods
Pigs: 2 days
Chickens: 2 days
Eggs: Zero
Turkeys: 5 days
Contra-indications
Do not use in animals hypersensitive to the active ingredient or any of the excipients.
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 may 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 1290 mg/kg bodyweight and for turkeys 840 mg/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 and sight 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% Concentrate for 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
Packaging quantities
1 litre high density polyethylene bottles with screw cap.
Further information
Nil.
Marketing Authorisation Holder (if different from distributor)
NA
Marketing Authorisation Number
Vm 00879/4052
Datasheet:
Denagard 12.5% w/v Concentrate for Oral Solution