TIAMUTIN 12.5 % AQUEOUS ORAL SOLUTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
05-11-2016
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Active ingredient:
TIAMULIN FUMARATE
Available from:
Elanco Europe Ltd
ATC code:
QJ01XQ01
INN (International Name):
TIAMULIN FUMARATE
Dosage:
12.5 Per Cent
Prescription type:
POM
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
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 21/10/2016_
_CRN 7023011_
_page number: 1_
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 should be re-established. Severely affected pigs that do
not drink should be medicated with Tiamutin 200 Injection.
Watering equipment should be inspected and cleaned prior to addition of Tiamutin 12.5% solution.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
W
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