NIGLUMINE
Country: Ítalía
Tungumál: enska
Heimild: HMA (Heads of Medicines Agencies)
Upplýsingar fylgiseðill
(PIL)
17-03-2012
Vara einkenni
(SPC)
17-03-2012
Virkt innihaldsefni:
flunixin meglumine 5 % w/v
Fáanlegur frá:
Laboratorios Calier
ATC númer:
QM01AG90
Lyfjaform:
Solution for injection
Meðferðarhópur:
flunixin
Lækningarsvæði:
Cattle Food, Horses Food, Pigs Food
Leyfisdagur:
2012-09-02
Upplýsingar fylgiseðill
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT :
NIGLUMINE 50mg/ml solution for injection for cattle, horses and pigs
Flunixin meglumine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
Active substance
Flunixin (meglumine)................................................................50.0 mg
(Equivalent to 82.9 mg flunixin meglumine)
Excipients
Phenol. ..........................................................................................5 mg
Other excipients ....................................................................... q.s. 1ml
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM:
Solution for injection
Colourless to slightly yellowish clear solution
4. CLINICAL PARTICULARS
4.1. TARGET SPECIES:
Cattle, horses and pigs.
4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE: For use in acute respiratory infection with appropriate antibiotic therapy to
reduce clinical signs.
HORSES: For the alleviation of inflammation and pain associated with musculoskeletal
disorders, especially in acute to sub-acute stages and to relieve visceral pain
associated with colic.
PIGS: For alleviation of Mastitis-Metritis-Agalactia Syndrome (MMA) with appropriate
antibiotic treatment to reduce clinical signs.
4.3. CONTRAINDICATIONS:
Do not use in animals suffering from chronic musculoskeletal disorders.
Do not use in animals suffering from hepatic, renal, or cardiac disease.
Do not use in animals with lesions of the gastrointestinal tract (for example gastro-
intestinal ulceration or bleeding).
Do not use when there is evidence of blood dyscrasia.
Do not use in anima
Lestu allt skjalið
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT :
NIGLUMINE 50mg/ml solution for injection for cattle, horses and pigs
Flunixin meglumine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
Active substance
Flunixin (meglumine)................................................................50.0 mg
(Equivalent to 82.9 mg flunixin meglumine)
Excipients
Phenol. ..........................................................................................5 mg
Other excipients ....................................................................... q.s. 1ml
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM:
Solution for injection
Colourless to slightly yellowish clear solution
4. CLINICAL PARTICULARS
4.1. TARGET SPECIES:
Cattle, horses and pigs.
4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE: For use in acute respiratory infection with appropriate antibiotic therapy to
reduce clinical signs.
HORSES: For the alleviation of inflammation and pain associated with musculoskeletal
disorders, especially in acute to sub-acute stages and to relieve visceral pain
associated with colic.
PIGS: For alleviation of Mastitis-Metritis-Agalactia Syndrome (MMA) with appropriate
antibiotic treatment to reduce clinical signs.
4.3. CONTRAINDICATIONS:
Do not use in animals suffering from chronic musculoskeletal disorders.
Do not use in animals suffering from hepatic, renal, or cardiac disease.
Do not use in animals with lesions of the gastrointestinal tract (for example gastro-
intestinal ulceration or bleeding).
Do not use when there is evidence of blood dyscrasia.
Do not use in anima
Lestu allt skjalið
