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Date: Thursday, May 30, 2024 2:28

Description: Huvepharma
Release 2.47
Tilmovet 250mg/ml Concentrate for Oral Solution
 
Species: Cattle, Chickens, Pigs, Turkeys
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Others
Active ingredient: Tilmicosin
Product:Tilmovet 250 mg/ml Concentrate for Oral Solution
Product index: Tilmovet 250 mg/ml Concentrate for Oral Solution
Cattle - meat: 42 days
Pig - meat: 14 days
Poultry - meat: See notes
Withdrawal notes: Broilers: 12 days. Turkeys: 19 days. Not permitted for use in laying birds producing eggs for human consumption.
Incorporating:
Qualitative and quantitative composition
Tilmicosin: 250 mg per ml.
Pharmaceutical form
Concentrate for oral solution. Clear yellow to amber solution.
Clinical particulars
Target species
Chickens (broilers and pullets), turkeys, pigs and cattle (calves).
Indications for use
Pigs: For the treatment and prevention of respiratory infections associated with Mycoplasma hyopneumoniae, Pasturella multocida and Actinobacillus pleuropneumoniae when the disease has been diagnosed at the herd level.
Chickens (broilers and pullets): For the treatment and prevention of respiratory infections in poultry flocks associated with Mycoplasma gallisepticum and Mycoplasma synoviae when the disease has been diagnosed at the herd level.
Turkeys: For the treatment and prevention of respiratory infections in turkey flocks associated with Mycoplasma gallisepticum and Mycoplasma synoviae when the disease has been diagnosed at the erd level.
Calves: For the treatment and prevention of respiratory infections associated with Mannheimia haemolytica, P. multocida, Mycoplasma bovis and M. dispar when the disease has been diagnosed at the herd level.
Contra-indications
Do not use in case of hypersensitivity to the active substance or in cases of known resistance to tilmicosin. Do not use in horses.
Special warnings for each target species
Tilmicosin should not be administered by injection to pigs. The product contains disodium edetate. The uptake of medicated water can be altered as a consequence of illness. If the uptake is insufficient, alternative treatment may be required.
Special precautions for use
Special precautions for use in animals
Inappropriate use of the product may increase the prevalence of bacteria resistant to tilmicosin and may decrease the effectiveness of treatment with tilmicosin related substances. Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
Do not allow horses or other equines access to drinking water containing tilmicosin.
Special precautions for the person administering the veterinary medicinal product to animals
People with known hypersensitivity to tilmicosin should avoid contact with the product. The veterinary medicinal product may cause irritation or sensitisation by skin contact.
Avoid skin and ocular contact. Wear protective gloves and protective clothes when handling the veterinary medicinal product.
In case of contact with skin or eyes, rinse abundantly with fresh water. If irritation persists and in case of incidental ingestion, seek immediately medical advice or call a poison center (dangers linked to disturbances in cardiac conduction).
Wash hand after use.
Adverse reactions
None known.
Use during pregnancy, lactation or lay
The safety of the product has not been established during pregnancy and lactation. Use only in accordance with risk/benefit assessment by the responsible veterinarian. Do not use in pullets and laying hens producing eggs for human consumption.
Interactions
Cross resistance between tilmicosin and other macrolide antibiotics and lincosamides has been observed. Tilmicosin may lessen the antibacterial activity of some β-lactam antibiotics.
Do not use simultaneously with bacteriostatic antimicrobial agents.
Amounts to be administered and administration route
For oral use only. The product must be diluted in drinking water or milk replacer before administration.
Pigs:
15-20mg tilmicosin per kg body weight for 5 days, i.e. 6-8ml of product for 100kg body weight corresponding to 80ml of product per 100 litres of drinking water for 5 days.
Chickens:
15-20mg tilmicosin per kg body weight for 3 days, i.e. 6-8ml of product for 100kg body weight corresponding to 30ml of product per 100 litres of drinking water for 3 days.
Turkeys:
10-27mg tilmicosin per kg body weight for 3 days, i.e. 4-11ml of product for 100kg body weight corresponding to 30ml of product per 100 litres of drinking water for 3 days.
Calves:
12.5mg tilmicosin per kg body weight two times per day for 3-5days, i.e. 1ml of product for 20kg body weight two times per day for 3-5 days.
One 960ml bottle is sufficient to medicate 1200 litres of drinking water for pigs or 3200 litres of drinking water for broilers, turkeys or pullets.
One 960ml bottle is sufficient to medicate drinking water or milk replacer for 48-80 calves (40kg b.w.)
One 240ml bottle is sufficient to medicate drinking water or milk replacer for 8 calves (60kg b.w.)
Medicated drinking water should be prepared fresh every 24 hours using only clean water.
Medicated milk replacer should be prepared fresh every 4 hours using only clean water.
If signs of disease do not significantly improve within 3-5 days, the diagnosis should be re-evaluated and treatment changed. To avoid underdosing, body weight should be determined as accurately as possible. The uptake of medicated water depends on the clinical condition of the animals. In order to obtain the correct dosage the concentration of the product has to be adjusted accordingly.
Do not administer to pigs in a wet feeding system.
Overdose
Pigs drink less water when a dose of 300 to 400 mg/litre (1.5 to 2 times the recommended dose) is administered. Although this will result in less intake of tilmicosin, it might lead to dehydration of the animals. Replace with untreated water when needed.
No symptoms were seen in poultry treated at 375 mg/litre during 5 days. A dose of 75 mg/litre during 10 days resulted in less consistent faeces.
No symptoms of overdose were noticed in turkeys treated at 375 mg/litre of drinking water during 3 days. No symptoms were noticed at 75 mg/litre during 6 days.
Except for a slight decrease in milk intake, no symptoms of overdose were seen in calves treated at 5 times the recommended dose or during twice the recommended treatment period.
Withdrawal periods
Meat and offal: Pigs: 14 days
Calves: 42 days
Broilers: 12 days
Turkeys: 19 days
Eggs: Not permitted for use in laying birds producing eggs for human consumption.
Pharmacological particulars
Pharmacotherapeutic group: antimicrobials for systemic use, macrolides
ATC vet code: QJ01FA91
Pharmacodynamic properties
Tilmicosin is a mainly bacteriocidal semi-synthetic antibiotic of the macrolide group. It is believed to affect bacterial protein synthesis.
Tilmicosin has a wide spectrum of activity against Gram-positive organisms and is particularly active against Pasterurella, Actinobacillus (Haemophilus) and Mycoplasma organisms of bovine, porcine and avian origin. Tilmicosin has some activity against certain Gram-negative micro-organisms. Cross resistance between tilmicosin and other macrolide antibiotics has been observed. Macrolides inhibit protein synthesis by reversibly binding to the 50S ribosomal subunitl. Bacterial growth is inhibited by induction of the separation of peptidyl transfer RNA from the ribosome during the elongation phase. Ribosomal methylase, encoded by the erm gene, can precipitate resistance to macrolides by alteration of the ribosomal binding site. The gene that encodes for an efflux mechanism, mef, also brings about a moderate degree of resistance. Resistance is also brought about by an efflux pump that actively rids the cells of the macrolide. This efflux pump is chromosomally mediated by genes referred to as acrAB genes. Resistance of Pseudomonas species and other Gramnegative bacteria, enterococci and staphylococci may be precipitated by chromosomally controlled alteration of permeability or uptake of the drug.
Pharmacokinetic properties
When administered orally to chickens, turkeys and pigs with drinking water and to calves with milk replacer, tilmicosin is absorbed and moves rapidly out of the serum into areas of low pH. This results in very low serum concentrations, but detectable levels of tilmicosin are found in lung tissues as early as 6 hours after starting the treatment. In chickens and turkeys, tilmicosin is also detected in pooled air sac tissue as early as 6 hours after starting the treatment. It is also known that tilmicosin is concentrated in alveolar macrophages of swine, When administered orally to calves tilmicosin is detected in lungs after 6 hours and remains at the therapeutic level up to 60 hours from the last dose.
Pharmaceutical particulars
Excipients
Propyl gallate (E310)
Disodium edetate
Phosphoric acid concentrated
Purified water
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
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 dilution in drinking water according to directions: 24 hours
Shelf life after reconstitution in milk replacer according to directions: 4 hours
Special precautions for storage
Do not store above 30oC. Protect from frost. Protect from light.
After dilution in drinking water/milk replacer: protect from light.
Immediate packaging
960ml is presented in a white high density polyethylene bottle with a white polypropylene or high density polyethylene, tamper-evident cap; 240ml is presented in high density polyethylene (HDPE) bottle with a tamper-evident screw closure made of polypropylene (PP).
Disposal
Any unused product or waste materials derived from the use of such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 30282/4001
Significant changes
Date of the first authorisation or date of renewal
28th October 2008
Date of revision of the text
May 2017
Any other information
Nil.
Legal category
Legal category: POM-V
GTIN
GTIN description:Tilmovet 250mg/ml Concentrate for Oral Solution
GTIN:05414916210203