Tyawalt 450 mg/g Granules for Use in Drinking Water for Pigs, Chickens and Turkeys

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Tiamulin Hydrogen Fumarate

Διαθέσιμο από:

KRKA UK Ltd

Φαρμακολογική κατηγορία (ATC):

QJ01XQ01

INN (Διεθνής Όνομα):

Tiamulin Hydrogen Fumarate

Φαρμακοτεχνική μορφή:

Granules for use in drinking water

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Chickens, Pigs, Turkeys

Θεραπευτική περιοχή:

Antimicrobial

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2018-01-16

Αρχείο Π.Χ.Π.

Revised: July 2021
AN: 00655/2021
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tyawalt 450 mg/g granules for use in drinking water for pigs, chickens
and
turkeys
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Tiamulin hydrogen fumarate
450 mg (corresponds to 364.28 mg of
tiamulin base)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules for use in drinking water
White to almost white small granules.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs, chickens and turkeys.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs

Treatment of Swine Dysentery caused by _Brachyspira hyodysenteriae_
susceptible to tiamulin. The presence of the disease in the herd must
be
established before the product is used.

Treatment of Porcine Colonic Spirochaetosis (colitis) caused by
_Brachyspira pilosicoli_ susceptible to tiamulin_. _The presence of
the disease
in the herd must be established before the product is used.

Treatment of Porcine Proliferative Enteropathy (ileitis) caused by
_Lawsonia _
_intracellularis _susceptible to tiamulin_. _The presence of the
disease in the
herd must be established before the product is used.

Treatment and metaphylaxis of Enzootic Pneumonia caused by
_Mycoplasma hyopneumoniae_, including infections complicated by
_Pasteurella multocida _susceptible to tiamulin_. _The presence of the
disease
in the herd must be established before the product is used.
Revised: July 2021
AN: 00655/2021
Page 2 of 9

Treatment of Pleuropneumonia caused by _Actinobacillus _
_pleuropneumoniae_ susceptible to tiamulin. The presence of the
disease in
the herd must be established before the product is used.
Chickens
Treatment and metaphylaxis of Chronic Respiratory Disease caused by
_Mycoplasma gallisepticum_ and Airsacculitis and Infectious Synovitis
caused
by _Mycoplasma synoviae _susceptible to tiamulin_. _The presence of
the disease
in the flock must be established before the product is