SODIUM SALICYL 800 MG/G, POWDER FOR ORAL SOLUTION FOR CATTLE (CALVES) AND PIGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM SALICYLATE PH. EUR. (EQUIVALENT TO SALICYLIC ACID AS SODIUM SALT)

Available from:

Dopharma Research B.V.

ATC code:

QN02BA04

INN (International Name):

SODIUM SALICYLATE PH. EUR. (EQUIVALENT TO SALICYLIC ACID AS SODIUM SALT)

Dosage:

800 Mg/Ml

Pharmaceutical form:

Powder for Oral Solution

Prescription type:

POM

Therapeutic group:

Bovine, Porcine

Therapeutic area:

Sodium salicylate

Therapeutic indications:

N.S.A.I.D

Authorization status:

Authorised

Authorization date:

2011-10-14

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Sodium Salicyl 800 mg/g, powder for oral solution for cattle (calves) and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 hypoproteinamia, 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.
Per gram:
Active substance
Sodium Salicylate
800 mg
(equivalent to 690 mg of salicylic acid as sodium salt)
Excipients
For the full list of excipients, see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 05/01/2017_
_CRN 7023500_
_page number: 1_
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 animals within 7 days after the end o