Sodium Salicyl 800 mg/g, Powder for Oral Solution for Cattle (Calves) and Pigs

Land: Storbritannia

Språk: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

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Preparatomtale Preparatomtale (SPC)
13-02-2023

Aktiv ingrediens:

Sodium Salicylate

Tilgjengelig fra:

Dopharma Research B.V.

ATC-kode:

QN02BA04

INN (International Name):

Sodium Salicylate

Legemiddelform:

Powder for oral solution

Resept typen:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Cattle, Pigs

Terapeutisk område:

Neurological Agent analgesic

Autorisasjon status:

Authorized

Autorisasjon dato:

2010-01-22

Preparatomtale

                                Revised: March 2022
AN: 02551/2021 and 02552/2021
Page 1 of 5
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
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 cases of hypersensitivity to sodium salicylate or to the
excipient.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: March 2022
AN: 02551/2021 and 02552/2021
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
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
of treatment.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
People with known hypersensitivity to sodium salicylate or related
substances (e.g.
aspirin) or excipients should avoid contact with the veterinary
medicinal product.
Irritation of th
                                
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