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Date: Monday, April 29, 2024 12:00

Release 2.183
Lincocin Soluble Powder for Oral Solution
 
Species: Chickens, Pigs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Others
Active ingredient: Lincomycin
Product:Lincocin® Soluble Powder
Product index: Lincocin Soluble Powder
Pig - meat: 1 day
Poultry - meat: 5 days
Poultry - eggs: See notes
Withdrawal notes: Not authorised for use in laying birds producing eggs for human consumption.
Incorporating:
Presentation
Lincocin Soluble Powder is a white to off-white powder for use in drinking water. Each gram contains lincomycin (as lincomycin hydrochloride) 400 mg.
Uses
Pigs
Treatment and metaphylaxis of enzootic pneumonia caused by Mycoplasma hyopneumoniae.
The presence of the disease in the group must be established before the product is used.
Chickens
Treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens.
The presence of the disease in the group must be established before the product is used.
Dosage and administration
For use in drinking water.
To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.
The intake of medicated water depends on the physiological and clinical condition of the animals. In order to obtain the correct dosage, the concentration of the lincomycin has to be adjusted accordingly.
The uptake of water should be monitored frequently.
The medicated water should be the only source of drinking water for the animals for the entire duration of the treatment period.
After the end of the medication period, the water supply system should be cleaned appropriately to avoid intake of sub-therapeutic amounts of the active substance.
Pigs: 10 mg lincomycin per kg of bodyweight (corresponding to 25 mg product per kg bodyweight) for 21 consecutive days.
Chickens: 5 mg lincomycin per kg of bodyweight (corresponding to 12.5 mg product per kg bodyweight) for 7 consecutive days.
Dosage (mg product per kg bodyweight per day)
X
Mean bodyweight (kg) of animals to be treated
________________________________________________________________________________
= mg product per litre drinking water
Average daily water intake
(litre/animal)
The use of suitably calibrated weighing equipment is recommended if part packs are used. The daily amount is to be added to the drinking water in such a way that all medication will be consumed within 24 hours. Medicated drinking water should be freshly prepared every 24 hours. No other source of drinking water should be available.
Contra-indications, warnings, etc
Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.
Do not administer, and do not allow access to water containing lincomycin, to rabbits, hamsters, guinea pigs, chinchillas, horses, or ruminants as this could result in severe gastrointestinal disturbance.
Do not use in cases of known resistance to lincosamides.
Do not use in cases of hepatic dysfunction.
Medicated drinking water uptake can be affected by the severity of the disease. In case of insufficient uptake of water, pigs should be treated parenterally.
The susceptibility of Mycoplasma hyopneumoniae to antimicrobial agents is difficult to test in vitro owing to technical constraints. In addition, there is a lack of clinical breakpoints for both M. hyopneumoniae and C. perfringens. Where possible, therapy should be based on local (regional, farm level) epidemiological information concerning the response of enzootic pneumonia/necrotic enteritis to treatment with lincomycin.
Use of the veterinary medicinal product preferably should be based on identification of the target pathogen and susceptibility testing of the bacteria isolated from the animal.
Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Use of the veterinary medicinal product deviating from the instructions given in the summary of product characteristics may increase the prevalence of bacteria resistant to the lincomycin and may decrease the effectiveness of treatment with other lincosamides, macrolides and streptogramin B due to the potential for cross-resistance.
Repeated or prolonged use should be avoided by improving the farm management and hygiene practices.
On rare occasions (more than 1 but less than 10 animals in 10,000 animals treated), pigs given lincomycin-medicated water may develop diarrhea/soft stools and/or mild swelling of the anus. On rare occasions some pigs may show reddening of the skin and mild irritable behaviour. These conditions are usually self-correcting within 5–8 days without discontinuing the lincomycin treatment. Allergic/hypersensitive reactions may occur on rare occasions.
A dosage greater than 10 mg lincomycin per kg of body weight may cause diarrhoea and loose stools in pigs. In case of accidental overdose, the treatment must be stopped and restarted at the recommended dose level. There is no specific antidote, treatment is symptomatic.
Laboratory studies in rats have not produced any evidence of teratogenic effects, although foetotoxicity has been reported. The safety of the veterinary medicinal product has not been established during pregnancy, lactation or lay in the target species. Use only according to the benefit-risk assessment by the responsible veterinarian.
Antagonism may exist between lincomycin and macrolides such as erythromycin and other bactericidal antibiotics; concurrent use is therefore not recommended due to competitive binding at the 50S ribosomal subunit of the bacterial cell.
The bioavailability of lincomycin may decrease in the presence of gastric antacids or activated charcoal, pectin or kaolin.
Lincomycin can potentiate neuromuscular effects of anaesthetics and muscle relaxants.
Withdrawal period
Pigs: meat and offal: 1 day.
Chickens: meat and offal: 5 days.
Not authorised for use in laying birds producing eggs for human consumption.
Operator warning
This product contains lincomycin and lactose monohydrate, either of which can cause allergic reactions in some people. People with known hypersensitivity to lincomycin or any other lincosamide, or to lactose monohydrate, should avoid contact with the veterinary medicinal product.
Care should be taken not to raise and inhale any dust.
Contact with skin and eyes should be avoided.
Personal protective equipment consisting of approved dust masks (either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator conforming to European Standard EN140 with a filter EN143), gloves and safety glasses should be worn when handling and mixing the product. If respiratory symptoms develop following exposure, seek medical advice and show this warning to the physician.
In case of accidental exposure to the skin, eyes or mucous membranes, wash the affected area thoroughly with plenty of water. If symptoms such as skin rash or persistent eye irritation appear after exposure, seek medical advice immediately and show the package leaflet or label to the physician.
Wash hands and any exposed skin with soap and water immediately after use.
Do not eat, drink or smoke while handling the product.
Pharmaceutical precautions
This veterinary medicinal product does not require any special storage conditions.
Shelf life after first opening the immediate packaging: use immediately.
Shelf life after reconstitution according to directions: 24 hours.
Do not mix with any other veterinary medicinal product.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
Supplied in a white HDPE bottle containing 150 g or 1.5 kg powder with a tamper evident LDPE lid and an aluminium cap (150 g pack only). Not all pack sizes may be marketed.
Further information
Nil.
Marketing Authorisation Number
Vm 42058/4078
Significant changes
GTIN
GTIN description:150 g:
GTIN:05013457085051