Sodium Salicyl 800 mg/g, powder for oral solution for cattle (calves) and pigs

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Sodium salicylate

Tilgængelig fra:

Dopharma Research B.V.

ATC-kode:

QN02BA04

INN (International Name):

Sodium salicylate

Dosering:

800 milligram(s)/gram

Lægemiddelform:

Powder for oral solution

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Cattle, Pigs

Terapeutisk område:

sodium salicylate

Terapeutiske indikationer:

N.S.A.I.D.

Autorisation status:

Authorised

Autorisation dato:

2011-10-14

Produktets egenskaber

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