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

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Kúpte ho teraz

DSU DSU (DSU)
23-06-2022

Aktívna zložka:

Sodium salicylate

Dostupné z:

Dopharma Research B.V.

ATC kód:

QN02BA04

INN (Medzinárodný Name):

Sodium salicylate

Dávkovanie:

800 milligram(s)/gram

Forma lieku:

Powder for oral solution

Typ predpisu:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutické skupiny:

Cattle, Pigs

Terapeutické oblasti:

sodium salicylate

Terapeutické indikácie:

N.S.A.I.D.

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2011-10-14

Súhrn charakteristických

                                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
                                
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