Pulmovet 250 mg/ml solution for use in drinking water or milk replacer for cattle, pigs, chickens and turkeys

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tilmicosin

Available from:

Dopharma Research B.V.

ATC code:

QJ01FA91

INN (International Name):

Tilmicosin

Dosage:

250 milligram(s)/millilitre

Pharmaceutical form:

Solution for use in drinking water/milk

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Chickens, Pigs, Turkeys

Therapeutic area:

tilmicosin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2018-05-04

Summary of Product characteristics

Health Products Regulatory Authority
03 October 2019
CRN008WJY
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pulmovet 250 mg/ml solution for use in drinking water or milk replacer
for cattle, pigs, chickens and turkeys
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
_ACTIVE SUBSTANCE:_
Tilmicosin (as tilmicosin phosphate): 250 mg
_EXCIPIENTS:_
​
Propyl gallate (E310):
​
0.2 mg
​
Disodium edetate:
​
2.0 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for use in drinking water or milk replacer.
Clear yellow to brown solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (pre-ruminant), pigs, chickens (except hens producing eggs for
human consumption) and turkeys.
4.2 INDICATIONS FOR USE, SPECIFYING THE 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 _Mycoplasma hyopneumoniae_, _Pasteurella _
_multocida_, _Actinobacillus pleuropneumoniae_ susceptible to
tilmicosin.
Chickens: For the treatment and metaphylaxis of respiratory disease
associated with _Mycoplasma gallisepticum_ and _M. synoviae_
susceptible to tilmicosin.
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 product is used.
4.3 CONTRAINDICATIONS
Do not allow horses and other equines access to drinking water
containing tilmicosin.
Do not use in case of hypersensitivity to tilmicosin or to any of the
excipients.
Health Products Regulatory Authority
03 October 2019
CRN008WJY
Page 2 of 6
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Important: Must be diluted before administration to animals.
Pigs, chickens and turkeys: Water consu