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

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: VMD (Veterinary Medicines Directorate)

Aktif bileşen:

Tilmicosin

Mevcut itibaren:

Dopharma Research B.V.

ATC kodu:

QJ01FA91

INN (International Adı):

Tilmicosin

Farmasötik formu:

Solution for use in drinking water/milk

Reçete türü:

POM-V - Prescription Only Medicine – Veterinarian

Terapötik grubu:

Cattle, Chickens, Pigs, Turkeys

Terapötik alanı:

Antimicrobial

Yetkilendirme durumu:

Authorized

Yetkilendirme tarihi:

2018-05-14

Ürün özellikleri

Unlimited renewal: September 2022
AN: 01219/2022
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 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.
Unlimited renewal: September 2022
AN: 01219/2022
Page 2 of 8
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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Important: Must be diluted before administration to animals.
Pigs, chickens and turkeys: Water consumption should be monitored in
order to
g