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Date: Wednesday, May 8, 2024 0:10

Release 2.99
Tiamvet® Solution 12.5% w/v oral solution for use in drinking water
 
Species: Pigs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Tablets
Active ingredient: Tiamulin Hydrogen Fumarate
Product:Tiamvet® Solution 12.5% w/v oral solution for use in drinking water
Product index: Tiamvet
Pig - meat: 2 days
Withdrawal notes: Pigs offal: 2 days
Incorporating:
Qualitative and quantitative composition
Composition for 1 ml:
Active substance:
Tiamulin hydrogen fumarate 125.0 mg. Equivalent to Tiamulin 101.2 mg
Excipients:
Benzyl alcohol 15.0 mg
For full list of excipients, see Pharmaceutical particulars.
Pharmaceutical form
Oral solution for use in drinking water. Clear, colourless to pale yellow solution.
Clinical particulars
Target Species
Pigs
Indications for use, specifying the target species
Pigs:
For the treatment, prevention and control of swine dysentery caused by Brachyspira hyodysenteriae and complicated by Fusobacterium and Bacteroides spp.
Contraindications
Do not administer products containing monensin, salinomycin or narasin during or for at least 7 days before or after treatment. Severe growth depression or death may result.
Special warnings for each target species
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.
Special precautions for use, including special precautions to be taken by the person administering the medicinal product to the animals
Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken into account when the product is used.
Special precautions to be taken by the person administering the medicinal product to animals
Do not eat, drink or smoke whilst using this product.
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.
Other precautions
None.
Adverse reactions (frequency and seriousness)
On rare occasions erythema or mild oedema of the skin may occur in pigs following the use of tiamulin hydrogen fumarate.
Use during pregnancy, lactation or lay
The product can be used in pregnant and lactating pigs.
Interaction with other medicinal products and other forms of interaction
See Contraindications
Amounts to be administered and administration route
Oral use. Administer in drinking water.
Pigs:
The dosage is 8.8 mg of the active substance per kg bodyweight daily, (equivalent to 10 ml 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.
To ensure an intake of 8.8 mg/kg daily it is important to know the weight of the animals to be treated and to measure accurately their drinking water consumption.
Administer the calculated dose (based on the animal's weight) in approximately one half of the daily water requirements, to ensure consumption of the correct dose. Unmedicated water should then 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.
Where a water medicator is used the appropriate stock solution should be made up according to the maker's instructions.
Any medicated water not consumed within 24 hours should be discarded.
If there is no response to treatment within 5 days, the diagnosis should be re-established.
Monitor water intake at frequent intervals during medication.
Fresh solutions of tiamulin-medicated drinking water should be made up each day.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
If signs of intoxication do occur, promptly remove the medicated water and replace with fresh water.
Withdrawal periods for the various foodstuffs, including those for which the withdrawal period is zero
Pigs (meat and offal): 2 days.
Pharmacological particulars
Pharmacotherapeutic group: Antibacterials for systemic use, other antibacterials, pleuromutilins. ATCvet code: QJ01XQ01
Pharmacodynamic properties
Tiamulin hydrogen fumarate is a semi-synthetic diterpene antibiotic. The mode of action is by inhibition of ribosomal protein synthesis in sensitive bacteria. It is a bacteriostatic antimicrobial and the following organisms show sensitivity in-vitro:
Brachyspira: Brachyspira hyodysenteriae, B. pilosicoli.
Mycoplasmas: Mycoplasma hyopneumoniae, M. hyorhinis, M. hyosynoviae, Ureaplasma spp.
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.
Pharmacokinetic particulars
Tiamulin is rapidly absorbed after oral administration. It concentrates in some tissues e.g. lungs and is rapidly metabolised and excreted.
Pharmaceutical particulars
List of excipients
Benzyl alcohol, Ethanol, Purified water.
Incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 3 months.
Shelf life after dilution or reconstitution according to directions: 24 hours.
Special precautions for storage
No special precautions for storage.
Nature and composition of immediate packaging
Material of the primary container:
Polyethylene high density bottles closed with polypropylene caps fitted with a polypropylene dosing device and poly vinyl chloride/vinyl acetate seal.
Dosing device:
Polypropylene measuring cup.
Pack sizes:
500 ml bottle, 1 litre bottle, 2 litres bottle, 5 litres bottle.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 15052/4028
Significant changes
Date of the first authorisation or date of renewal
Date: 14 September 2007
Date of revision of the text
Date: May 2012
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:Tiamvet 12.5% 1 L
GTIN:03411111839286