Tylogran, 1000 mg/g, granules for use in drinking water/milk for cattle (calves), pigs, chickens and turkeys

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tylosin tartrate

Available from:

Dopharma Research B.V.

ATC code:

QJ01FA90

INN (International Name):

Tylosin tartrate

Pharmaceutical form:

Powder for use in drinking water/milk

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

tylosin

Authorization date:

2022-12-23

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT_ _
TYLOGRAN, 1000 mg/g, granules for use in drinking water/milk for
cattle (calves), pigs, chickens
and turkeys (AT, BE, BG, CZ, CY, DE, DK, EE, EL, FI, HU, IE, IS, IT,
LT, LU, LV, NL, NO, PL,
PT, RO, SE, SK)
TYLOGRAN, 100%, granules for use in drinking water/milk for cattle
(calves), pigs, chickens and
turkeys (FR)
TYLOGRAN, 909 mg/g, granules for use in drinking water/milk for cattle
(calves), pigs, chickens and
turkeys (HR)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1.1 g contains:
ACTIVE SUBSTANCE:
1 g of tylosin (1000000 IU tylosin, equivalent to 1.1 g of tylosin
tartrate)
Almost white to slightly yellow, granular powder.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle (calves), pigs, chickens and turkeys.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Calves: treatment and metaphylaxis of
- pneumonia caused by
_Mycoplasma _
spp.
Pigs: treatment and metaphylaxis of
- enzootic pneumonia caused by
_Mycoplasma hyopneumoniae_
and
_Mycoplasma hyorhinis_
;
- Porcine Intestinal Adenomatose (PIA or Ileitis) associated with
_Lawsonia intracellularis_
.
Turkeys: treatment and metaphylaxis of
- infectious sinusitis caused by
_Mycoplasma gallisepticum_
.
Chickens: treatment and metaphylaxis of
- chronic respiratory diseases (CRD) caused by
_Mycoplasma gallisepticum_
and
_Mycoplasma synoviae_
;
- necrotic enteritis caused by
_Clostridium perfringens_
.
The presence of the disease in the group/flock must be established
before the veterinary medicinal
product is used.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to tylosin or other
macrolides.
Do not use in animals with hepatic disorders.
Do not use in horses.
3.4
SPECIAL WARNINGS
Severely sick animals that exhibit an altered eating and drinking
behaviour should be medicated
parenterally.
Do not use in cases of known resistance to tylosin or cross-resistance
to other macrolides (MLS-
resistance).
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Due to likely variabi