TIAMUTIN 12.5 % AQUEOUS ORAL SOLUTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TIAMULIN FUMARATE

Available from:

Elanco Europe Ltd

ATC code:

QJ01XQ01

INN (International Name):

TIAMULIN FUMARATE

Dosage:

12.5 Per Cent

Pharmaceutical form:

Infus/Pdr/Oral Soln

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Porcine

Therapeutic area:

tiamulin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2016-10-21

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tiamutin 12.5% Aqueous Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Yellowish, viscous aqueous solution with a characteristic odour.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Porcine.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the oral treatment of swine dysentery caused by_ Serpulina
(Treponema) hyodysenteriae_ complicated by_ Fusobacterium_
spp. and_ Bacteroides_ spp.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredient.
Animals should not receive products containing monensin, salinomycin
or narasin during or for at least seven days before
or after treatment with Tiamutin 12.5% Solution.
Severe growth depression or death may result.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
For use in the drinking water of pigs only.
Each ml contains:
Active Substance
Tiamulin hydrogen fumarate 125.0 mg
Excipients
Methyl parahydroxybenzoate
0.9 mg
Propyl parahydroxybenzoate
0.1 mg
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTION(S) FOR USE IN ANIMALS
Fresh medicated water must be prepared every 24 hours.
If there is no response to treatment within five days, the diagnosis
shou