Pulmovet 250 mg/ml Solution for Use in Drinking Water/Milk for Cattle, Pigs, Chickens and Turkeys

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Tilmicosin

Saatavilla:

Dopharma Research B.V.

ATC-koodi:

QJ01FA91

INN (Kansainvälinen yleisnimi):

Tilmicosin

Lääkemuoto:

Solution for use in drinking water/milk

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Cattle, Chickens, Pigs, Turkeys

Terapeuttinen alue:

Antimicrobial

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2018-05-14

Valmisteyhteenveto

Revised: February 2024
AN: 03332/2022
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Pulmovet 250 mg/ml solution for use in drinking water/milk for cattle,
pigs, chickens and
turkeys
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Tilmicosin (as tilmicosin phosphate): 250 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS_ _
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCt
Propyl gallate (E310)
0.2 mg
Disodium edetate
2.0 mg
Phosphoric acid, concentrated (for pH
adjustment)
Purified water
Clear yellow to brown solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle (pre-ruminant), pigs, chickens (except hens producing eggs for
human
consumption) and turkeys.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Calves: For the treatment and metaphylaxis of bovine respiratory
disease, associated with
_Mannheimia haemolytica_, _Pasteurella multocida_, _Mycoplasma bovis_
and _M. dispar_
susceptible to tilmicosin.
Pigs: For the treatment and metaphylaxis of respiratory disease
associated with
_Pasteurella multocida_, _Actinobacillus pleuropneumoniae_ and
_Mycoplasma hyopneumoniae_
susceptible to tilmicosin.
Chickens: For the treatment and metaphylaxis of respiratory disease
associated with
_Mycoplasma gallisepticum_ and _M. synoviae_ susceptible to
tilmicosin.
Revised: February 2024
AN: 03332/2022
Page 2 of 8
Turkeys: For the treatment and metaphylaxis of respiratory disease
associated with
_Mycoplasma gallisepticum_ and _M. synoviae_ susceptible to
tilmicosin.
The presence of the disease in the group/flock must be established
before the veterinary
medicinal product is used.
3.3
CONTRAINDICATIONS
Do not allow horses and other equines access to drinking water
containing tilmicosin.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
3.4
SPECIAL WARNINGS
Important: Must be diluted before administration to animal