Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LINCOMYCIN (AS LINCOMYCIN HYDROCHLORIDE PH. EUR.)
Zoetis Belgium S.A.
QJ01FF02
LINCOMYCIN (AS LINCOMYCIN HYDROCHLORIDE PH. EUR.)
400 mg/g
Powder for Oral Solution
POM
Porcine
Lincomycin
Antibacterial
Authorised
2017-04-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Lincocin Soluble Powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Powder for oral solution. White to off-white free-flowing powder. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of swine dysentery. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to active ingredient. Do not treat animals with lincomycin and erythromycin concurrently. Do not administer to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants as this could result in severe gastro- intestinal disturbance. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None known. Each gram contains: Active substance: Lincomycin 400 mg (as lincomycin hydrochloride) For a full list of excipients see section 6.1. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _8_ _/_ _0_ _4_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _5_ _3_ _6_ _5_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTION(S) FOR USE IN ANIMALS: Avoid inhaling dust and contact with skin. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS: Avoid skin contact and inhalation of dust. Wash hands and exposed skin after use. Persons known to be hypersensitive to the active ingredient should handle the product with care. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIO Read the complete document