Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Lincomycin hydrochloride monohydrate; Spectinomycin sulfate tetrahydrate
Huvepharma NV
QJ01FF52
Lincomycin hydrochloride monohydrate; Spectinomycin sulfate tetrahydrate
Powder for use in drinking water
POM: Prescription Only Medicine as defined in relevant national legislation
lincomycin, combinations
2023-09-08
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Lincoral-S 222 mg/g + 444.7 mg/g powder for use in drinking water 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains: ACTIVE SUBSTANCES: Lincomycin 222 mg (equivalent to 251.7 mg of lincomycin hydrochloride monohydrate) Spectinomycin 444.7 mg (equivalent to 672.4 mg of spectinomycin sulfate tetrahydrate) EXCIPIENT: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS Lactose monohydrate White to almost white powder. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Pigs and chickens. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES Pigs For the treatment and metaphylaxis of porcine proliferative enteropathy (ileitis) caused by _Lawsonia intracellularis_ , and associated enteric pathogens ( _Escherichia coli_ ). The presence of the disease in the group must be established before the veterinary medicinal product is used. Chickens For the treatment and metaphylaxis of chronic respiratory disease (CRD) caused by _Mycoplasma _ _gallisepticum _ and _Escherichia coli _ and associated with a low mortality rate. The presence of the disease in the group must be established before the veterinary medicinal product is used. 3.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substances or any of the excipients. Do not use in cases of hepatic dysfunction. Do not allow rabbits, rodents (e.g. chinchillas, hamsters, guinea pigs), horses or ruminants access to water or feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Do not use in laying hens. 3.4 SPECIAL WARNINGS In _E. coli, _ a significant number of the strains show high MIC values (minimum inhibitory concentrations) against the lincomycin-spectinomycin combination and may be clinically resistant, although no breakpoint is defined. Due to technical constraints, the susceptibility of _L. intracellularis _ is _ _ difficult to test _in vitro_ , and data about the lincomycin-spectinomycin resistance status in that species are lacking. Cross-resistanc Lugege kogu dokumenti