Equibactin 250 mg/g + 50 mg/g oral powder for horses

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Sulfadiazine ; Trimethoprim

Fáanlegur frá:

Le Vet Beheer B.V.

ATC númer:

QJ01EW10

INN (Alþjóðlegt nafn):

Sulfadiazine ; Trimethoprim

Skammtar:

250, 50 milligram(s)/gram

Lyfjaform:

Oral powder

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Lækningarsvæði:

sulfadiazine and trimethoprim

Leyfisstaða:

Authorised

Leyfisdagur:

2019-07-05

Vara einkenni

Health Products Regulatory Authority
22 July 2019
CRN000VD7
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Equibactin 250 mg/g + 50 mg/g oral powder for horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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Each gram contains:
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ACTIVE SUBSTANCES:
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Sulfadiazine
​250
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mg
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Trimethoprim
50
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mg
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EXCIPIENTS:
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For the full list of excipients, see section 6.1.
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3 PHARMACEUTICAL FORM
Oral powder.
White to off-white powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections in horses caused by micro-organisms
susceptible to the combination of trimethoprim and
sulfadiazine, such as infections of the upper respiratory tract, the
urogenital system and wound infections.
4.3 CONTRAINDICATIONS
Do not use in horses with severe liver or kidney disease.
Do not use in known cases of hypersensitivity to the active substances
or to any of the excipients.
Do not use in known cases of resistance to trimethoprim and
sulphonamides.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Throughout the treatment, animals should have free access to drinking
water to avoid possible crystalluria.
In the treatment of new-born animals and animals with liver damage,
caution should be exercised.
Renal impairment may cause accumulation, increasing the risk of side
effects in long term treatment.
Use the product cautiously in horses with blood dyscrasias.
Use of the product should be based on identification and
susceptibility testing of the target pathogen(s). If this is not
possible,
therapy should be based on epidemiological information and knowledge
of susceptibility of the target bacteria at farm level, or
at local/regional level.
Use of the product should be in accordance with official, national and
regional antimicrobial policies.
Use of the product deviating from the instru