Denagard® 12.5% Solution (UK)

Tiamulin hydrogen fumarate solution.
 

For oral administration in the drinking water of chickens and turkeys.

An aqueous solution containing 125mg tiamulin hydrogen fumarate per ml. The solution also contains methylparahydroxybenzoate (0.9 mg/ml) and propylparahydroxybenzoate (0.1 mg/ml) as preservatives.

Actions:
The following organisms show sensitivity to tiamulin hydrogen fumarate in vitro:
Brachyspira: Brachyspira hyodysenteriae, B. pilosicoli.
Mycoplasmas: Mycoplasma hyopneumoniae, M. hyorhinis,
M. hyosynoviae, Ureaplasma spp, M. gallisepticum, M. synoviae,
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.

Chickens:
For the reduction in the severity of disease caused by mycoplasmas.
 

Turkeys:
For the reduction in the severity of disease caused by mycoplasmas.

Chickens:
The dosage for chickens is 25mg of active substance per kg bodyweight (equivalent to 100ml of product per 500 kg bodyweight). Tiamulin should be administered at 0.025% in drinking water (2ml product per litre 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 25mg of active substance per kg bodyweight (equivalent to 100ml of product per 500kg bodyweight). Tiamulin should be administered at 0.025% tiamulin in the drinking water (2ml product per litre 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: 25 - 30 mg/kg bodyweight
20 week old poult: 25 mg/kg bodyweight
Fresh solutions of tiamulin-medicated drinking water should be made up each day.

Warnings:
Birds must not be slaughtered for human consumption during treatment.
 

Chickens may be slaughtered for human consumption only after 2 days from the last treatment. Nil withdrawal period for eggs.
 

Turkeys may be slaughtered for human consumption only after 5 days from the last treatment.
 

Contra-indications:
Do not use in birds hypersensitive to the active ingredient. Birds should not receive products containing monensin, narasin or salinomycin, during or for at least seven days before or after treatment with Denagard 12.5% Solution. Severe growth depression or death may result. Concomitant use of tiamulin and the ionophore anticoccidal 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 to the skin should be washed off immediately.
 

Wash hands after use.
 

Pregnancy and Lactation:
Denagard is suitable for use 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.
 

Pharmaceutical Warnings:
Fresh medicated water must be prepared every 24 hours. Watering equipment should be thoroughly cleaned prior to addition of Denagard 12.5% Solution. Do not store above 25°C.
 

Precautions:
For use in drinking water of chickens and turkeys only.
 

• Monitor water intake at frequent intervals during medication.
• If there is no response to treatment within five days, the diagnosis should be re-established.
• Water intake may be depressed during the administration of tiamulin to birds. It appears to be concentration dependent with 0.025% 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.

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

For animal treatment only.
 

Keep out of reach of Children.
 

® Registered trademark of Novartis AG, Basel, Switzerland.