Sulphadimidine Sodium Powder for Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sulphadimidine sodium bp

Available from:

Eurovet Animal Health B.V.

ATC code:

QJ01EQ03; QP51AG01

INN (International Name):

Sulphadimidine sodium bp

Dosage:

1000 milligram(s)/gram

Pharmaceutical form:

Powder for oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Chickens, Other Birds

Therapeutic area:

sulfadimidine; sulfadimidine

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1988-10-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Sulphadimidine Sodium Powder for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
PER G POWDER:
Sulphadimidine Sodium
1000 mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
A white or creamy white odourless powder
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and poultry (non-laying hens and broilers).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections caused by micro-organisms (both
bacteria and coccidia) susceptible to sulphadimidine.
4.3 CONTRAINDICATIONS
Do not
use in animals with serious liver
and renal
disturbances or
in animals with diseases accompanied with a
decreased intake of fluids or a decreased urine production, or in
cases of aciduria.
Do not use in animals with damage to the haematopoietic system.
Do not administer to laying hens.
Do not use in cases of hypersensitivity to the active ingredient.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
After
administration of
this product
to ruminants,
sometimes a temporary interference with ruminal
function and
microfloral activity may occur.
However, spontaneous recovery is likely.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Monitor water intake in poultry and calves during treatment.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Avoid skin contact with the powder and avoid inhalation of the dust.
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