Bilovet 200 mg/ml Solution for Injection for Cattle and Pigs

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Tylosin

Tilgængelig fra:

Cross Vetpharm Group Ltd

ATC-kode:

QJ01FA90

INN (International Name):

Tylosin

Lægemiddelform:

Solution for injection

Recept type:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Cattle, Pigs

Terapeutisk område:

Antimicrobial

Autorisation status:

Authorized

Autorisation dato:

2014-12-22

Produktets egenskaber

Revised: March 2018
Amended pages
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bilovet 200 mg/ml Solution for Injection for cattle and pigs - UK, IE,
BE, DE, IT, NL,
ES, RO
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per ml:
ACTIVE SUBSTANCE:
Tylosin 200 mg (equivalent to 200,000 IU/ml)
EXCIPIENT:
Benzyl alcohol 41.66 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection.
Clear, yellow aqueous solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Infections caused by microorganisms susceptible to tylosin.
Cattle (adult):
- Treatment of respiratory infections, metritis caused by
Gram-positive micro-
organisms, mastitis caused by _Streptococcus _spp., _Staphylococcus
_spp. and
interdigital necrobacillosis, caused by _Fusobacterium necrophorum_ ,
i.e. panaritum or
foot rot.
Calves:
- Treatment of respiratory infections and necrobacillosis (calf
diphtheria cause by
_Fusobacterium necrophorum)_.
Pigs:
- Treatment of enzootic pneumonia caused by _Mycoplasma
hyopneumoniae_,,
haemorrhagic enteritis, (Porcine proliferative haemorrhagic
enteropathy due to
_Lawsonia intracellularis_) erysipelas caused by _Erysipelothrix
rhusiopathiae _and
metritis.
- Treatment of arthritis caused by _Mycoplasma _and _Staphylococcus
_spp.
Page 1 of 5
Revised: March 2018
Amended pages
4.3
CONTRAINDICATIONS
The product should not be given to chickens or turkeys.
Do not administer to horses or other equines in which injection of
tylosin may be
fatal.
Do not administer to animals with known hypersensitivity to tylosin,
other macrolides
or any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of the product should be based on susceptibility testing of the
bacteria isolated
from the animal. If this is not possible, therapy should be based on
local
epidemiological information.
For administration by the intra