TIAMUTIN PREMIX 2% W/W PREMIX FOR MEDICATED FEED FOR PIGS, CHICKENS AND RABBITS
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:
2 %w/w
Pharmaceutical form:
Premix for Med.Feedstuffs
Prescription type:
POM
Therapeutic group:
Fowl - Chicken, Fowl - Turkey, Porcine, Rabbits
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 Premix 2% w/w
Premix for medicated feed for pigs, chickens and rabbits.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Tiamulin hydrogen fumarate
20 mg/g
_Excipients: _For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Premix for medicated feeding stuff.
Brown, free-flowing granulate.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
Chickens (broiler, replacement pullet, layer/breeder).
Turkeys (poult (grower) and breeder).
Rabbits.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs
For the treatment and prevention of swine dysentery caused by _Brachyspira hyodysenteriae_.
For the treatment of colitis caused by _Brachyspira pilosicoli_.
For the treatment of ileitis caused by _Lawsonia intracell_ularis.
For the treatment of enzootic pneumonia caused by _Mycoplasma hyopneumoniae_.
Chickens
For the treatment and prevention of chronic respiratory disease (CRD) and air sacculitis caused by _Mycoplasma_
_gallisepticum _and _Mycoplasma synoviae_.
Turkeys
For the treatment and prevention of infectious sinusitis and air sacculitis caused by _Mycoplasma gallisepticum_,
_Mycoplasma meleagridis _and _Mycoplasma synoviae_.
Rabbits
For the treatment and prevention of epizootic rabbit enterocolitis (ERE).
4.3 CONTRAINDICATIONS
Animals should not receive products containing ionophores (monensin, narasin or salinomycin) during or for at least seven
days before or after treatment with tiamulin. Severe growth depression or death may result.
Refer to section 4.8 for information regarding interaction between tiamulin and ionophores.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 21/10/2016_
_CRN 7023013_
_p
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