Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Sodium salicylate
Dopharma Research B.V.
QN02BA04
Sodium salicylate
800 milligram(s)/gram
Powder for oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Pigs
sodium salicylate
N.S.A.I.D.
Authorised
2011-10-14
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT SODIUM SALICYL 80% WSP, powder for oral solution for cattle (calves) and pigs (BE, BG, DE, EE, EL, HU, IT, LT, LV, NL, PT, RO). SODIUM SALICYL 800 mg/g, powder for oral solution for cattle (calves) and pigs (IE, UK). SALIMED 800 mg/g, powder for oral solution for cattle (calves) and pigs (PL). SALIVET 80%, powder for oral solution for cattle (calves) and pigs (FR). SINTEM 800 mg/g, powder for oral solution for cattle (calves) and pigs (ES). SODILIN, 800 mg/g, powder for oral solution for cattle (calves) and pigs (DK). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per gram: _ACTIVE SUBSTANCE: _ Sodium salicylate: 800 mg (equivalent to 690 mg of salicylic acid as sodium salt) _EXCIPIENT_ : For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral solution. White or almost-white powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (calves) and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Calves: For supportive treatment of pyrexia in acute respiratory disease, in combination with appropriate (anti-infective) therapy if necessary. Pigs: For the treatment of inflammation, in combination with concurrent antibiotic therapy. 4.3 CONTRAINDICATIONS Do not administer to animals with severe hypoproteinaemia, liver and kidney affections. Do not administer in case of gastrointestinal ulcerations and chronic gastrointestinal disorders. Do not administer in case of malfunction of the hematopoetic system, coagulopathies, haemorrhagic diathesis. Do not use sodium salicylates in neonates or calves less than 2 weeks of age. Do not use in piglets less than 4 weeks of age. Do not use in animals with known hypersensitivity to sodium salicylate or to excipient. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE I. SPECIAL PRECAUTIONS FOR USE IN ANIMALS Given that sodium salicylate may inhibit clotting of blood, it is recommended that elective surgery should not be performed on a Lue koko asiakirja