Pulmotil AC Concentrate for oral solution for use in drinking water or milk replacer

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tilmicosin

Available from:

Elanco GmbH

ATC code:

QJ01FA91

INN (International Name):

Tilmicosin

Dosage:

250 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

tilmicosin

Authorization status:

Authorised

Authorization date:

1999-02-05

Summary of Product characteristics

Health Products Regulatory Authority
25 September 2020
CRN009LLK
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pulmotil AC Concentrate for oral solution for use in drinking water or
milk replacer
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:​
ACTIVE SUBSTANCE:
​
​
Tilmicosin (as phosphate)
​
250.0 mg
​
​
​
EXCIPIENTS:
​
​
Propyl gallate
​
0.2 mg
​
Disodium edetate
​
2.0 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for oral solution for use in drinking water or milk
replacer.
Clear yellow to amber coloured solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (except hens producing eggs for human consumption)
Turkeys
Pigs
Calves (pre-ruminant)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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_._
Calves: For the treatment and metaphylaxis of bovine respiratory
disease, associated with _Mannheimia haemolytica, Pasteurella _
_multocida, Mycoplasma bovis, M. dispar_ 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 known cases of hypersensitivity to active substance or
to any of the excipients.
Do not use in ruminants with active rumen function.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Important: Must be diluted before administration to animals.
Health Products Regulatory Authority
25 Septem