Dophacyl 1000 mg/g, powder for use in drinking water/milk for cattle and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium salicylate

Available from:

Dopharma Research B.V.

ATC code:

QN02BA04

INN (International Name):

Sodium salicylate

Pharmaceutical form:

Powder for use in drinking water/milk

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

sodium salicylate

Authorization date:

2023-08-14

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dophacyl 1000 mg/g, powder for use in drinking water/milk for cattle
and pigs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Sodium salicylate: 1000 mg
(equivalent to 863 mg of salicylic acid)
EXCIPIENT
:
None.
White or almost-white powder.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle (calves) and pigs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Calves:
For supportive treatment of pyrexia in acute respiratory disease, in
combination with appropriate (e.g. anti-
infective) therapy if necessary.
Pigs:
- for the treatment of inflammation, in combination with appropriate
(e.g. anti-infective) therapy if necessary;
- to promote recovery of respiration and to reduce coughing in
respiratory infections, in combination with
concurrent antibiotic therapy.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance.
Do not use in animals with severe hypoproteinaemia, liver and kidney
disorders.
Do not use 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 gastrointestinal ulcers and chronic
gastrointestinal disorders.
Do not use in animals with malfunction of the hematopoietic system,
coagulopathies and hemorrhagic
diathesis.
3.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
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:
This veterinary medicinal product may cause hypersensitivity
reactions. People with known hypersensitivity
(allergies) to sodium salicylate or related substances (e.g. aspirin)
should avoid contact with the veterinary
medicinal product.
If, after accidental contact rash develops, seek medical advice and
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