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1.
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NAME OF THE VETERINARY MEDICINAL PRODUCT
Amix Vet T 100 premix for medicated feeding stuff for pigs
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2.
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QUALITATIVE AND QUANTITATIVE COMPOSITION
Each kg contains: Tiamulin hydrogen fumarate 100g
For a full list of excipients: see section 6.1
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3.
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PHARMACEUTICAL FORM
Premix for medicated feeding stuff
A light brown free-flowing powder
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4.
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CLINICAL PARTICULARS
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4.1
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Target species
Pigs
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4.2
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Indications for use (specifying the target species)
For treatment and prevention of swine respiratory and digestive tracts infections sensitive to tiamulin (when the disease is present at herd level)
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The presence of disease in the herd should be established before use.
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4.3
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Contraindications
Do not use in cases of known hypersensitivity to the active substances or any of the excipients.
Do not administer products containing ionophores such as monensin, salinomycin or narasin during or for at least seven days before or after treatment with the product.
See section 4.8.
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4.4
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Special warnings (for each target species)
The uptake of medication by animals can be altered as a consequence of illness..
Long term or repeated use should be avoided by improving management practice and thorough cleansing and disinfection.
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4.5
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Special precautions for use
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4.5.1
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Special precautions for use in animals
Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
If there is no response to treatment within 3 days, the diagnosis should be re-established.
Avoid concurrent administration of tiamulin and the ionophore products monensin, narasin and salinomycin (see section 4.8). Inform the feed supplier that tiamulin will be used, to avoid incorporating the above listed products in the feed and to avoid contamination of the feed. In case of a suspected contamination, test the feed for the presence of these ionophores before feeding. If adverse effects occur due to an interaction, stop administration of the feed immediately. Remove the contaminated feed as soon as possible and replace with uncontaminated feed.
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4.5.2
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Special precautions for the person administering the veterinary medicinal product to animals
Direct contact with the skin, eyes and mucous membranes should be avoided by wearing overalls, impermeable rubber gloves and safety glasses when mixing or handling the product.
In case of accidental eye contact, irrigate the eyes thoroughly with clean running water immediately. Seek medical advice if irritation persists.
When handling the product, inhalation of the dust must be avoided by wearing a disposable half-mask.
Accidental ingestion should be avoided.
Contaminated clothing should be removed and any splashes on to the skin should be washed off immediately.
Wash hands after use.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.
People with known hypersensitivity to tiamulin should handle the product carefully.
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4.6
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Adverse reactions (frequency and seriousness)
In rare cases, hypersensitivity to tiamulin following oral administration is reported in terms of acute dermatitis with cutaneous erythema and intense pruritus. The adverse reactions are usually mild and transient but in very rare cases may be serious. If these typical side effects occur, stop treatment immediately and clean animals and pens with water. Normally, affected animals recover quickly. Symptomatic treatment such as electrolyte therapy and an anti-inflammatory therapy may be useful.
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4.7
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Use during pregnancy, lactation or lay
The product can be used during pregnancy and lactation.
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4.8
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Interaction with other medicinal products and other forms of interaction
Tiamulin is known to produce clinically important (often lethal) interactions with ionophore antibiotics, including monensin, narasin, salinomycin. Therefore, pigs should not receive products containing such compounds during or for at least seven days before or after treatment with this product. Severe growth depression or death may result.
See also Section 4.3 and 4.5.1.
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4.9
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Amount(s) to be administered and administration route
For oral administration only after incorporation in medicated feed.
For the treatment and prevention, when disease is confirmed at the herd level, of Treatment of swine desyentry:
1,0-1,5 kg premix per tonne of feed (equivalent to 100-150 g tiamulin/tonne) i.e. 100-150 ppm (5-7,5mg tiamulin/body weight) for 7-10 days
For treatment of enzootic pneumonie
10 mg tiamulin hydrogen fumarate per kg bodyweight per day for 7-10 consecutive days. this dose is obtained by mixing 2,0 kg of Premix per tonne of feed (200 ppm).
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4.10
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Overdose (symptoms, emergency procedures, antidotes), if necessary
Tiamulin hydrogen fumarate has a relatively high therapeutic index in pigs.
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4.11
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Withdrawal period(s)
Meat and offal: 7 days
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5.
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PHARMACOLOGICAL OR IMMUNOLOGICAL PROPERTIES
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ATC Vet Code:
QJ01XQ01
Pharmacotherapeutic group: antibacterials for systemic use, pleuromutilins
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5.1
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Pharmacodynamic properties
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Tiamulin hydrogen fumarate is a semi-synthetic derivative of the diterpene antibiotic pleuromutilin, produced by Pleurotus mutilis.
Tiamulin is active against pathogenic mycoplasmas, against most Gram-positive organisms and Gram-negative organisms. Tiamulin is bacteriostatic and inhibits protein synthesis. The product has a strong affinity for the ribosome, causing an inhibition of peptidyltransferasis. As a result protein synthesis is stopped.
In vitro research has shown that resistant bacterial mutants can be created through multi step resistance. In practice, resistance in mycoplasmas has been reported rarely. Resistance against B. hyodysenteriae has been seen, however this spirochete remains very sensitive to tiamulin.
If response to treatment of dysentery with the product is poor, then the possibility of resistance must be considered. Cross resistance between tiamulin and tylosin has been reported.
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5.2
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Pharmacokinetic particulars
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Following oral administration, tiamulin hydrogen fumarate is rapidly absorbed from the gastrointestinal tract of pigs (85-90%) and appears in the blood within 30 minutes. 2-4 hours (tmax) after the oral administration of 10 mg tiamulin/kg BW in the form of an oral solution, a Cmax of 1 µg/ml was measured; an oral administration of 25 mg/kg gave a Cmax of 1.82 µg/ml.
There is very good distribution in the tissues with accumulation in lungs and in the colon. 30-50% of tiamulin is bound to serum proteins.
Tiamulin is rapidly metabolised in the liver (hydroxylation, de-alkalysation, hydrolysis). At least 16 biologically inactive metabolites have been identified. The excretion of tiamulin and its metabolites is through the bile and faeces (70-85%). The remainder is excreted through the urine (15-30%).
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6.
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PHARMACEUTICAL PARTICULARS
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6.1
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List of excipients
Farina
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6.2
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Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other medicinal products
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6.3
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Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 24 months
Shelf life after first opening the immediate packaging: 3 months
Shelf life after incorporation in the feed: 3 months
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6.4
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Special precautions for storage
Store below 25°C. Store in a dry place.
Store in the original container
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6.5
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Nature and composition of immediate packaging
The product is presented in a 10 kg and a 20 kg multi-walled paper bag
Not all pack sizes may be marketed
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6.6
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Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused product or waste material should be disposed of in accordance with national requirements.
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7.
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MARKETING AUTHORISATION HOLDER
Cymedica spol. s r.o.,
Hořovice
Czech Republic
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8.
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MARKETING AUTHORISATION NUMBER
In Czech Republic
98/164/98-C
In Slovak Republic
98/051/04-S
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