Tilmovet 300 mg/ml Solution for Injection for cattle and sheep

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Tilmicosin

Tilgængelig fra:

Huvepharma NV

ATC-kode:

QJ01FA91

INN (International Name):

Tilmicosin

Dosering:

300 milligram(s)/millilitre

Lægemiddelform:

Solution for injection

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk område:

tilmicosin

Autorisation status:

Authorised

Autorisation dato:

2019-05-24

Produktets egenskaber

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tilmovet 300 mg/ml Solution for Injection for cattle and sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Tilmicosin
300 mg
Excipient(s):
Propylene glycol (E1520) 250 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear amber yellow liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and sheep.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE
Treatment of bovine respiratory disease associated with
_Mannheimia haemolytica _
and
_Pasteurella multocida_
.
Treatment of interdigital necrobacillosis.
SHEEP
Treatment of respiratory tract infections caused by
_Mannheimia haemolytica _
and
_Pasteurella _
_multocida_
.
Treatment of foot rot in sheep caused by
_Dichelobacter nodosus _
and
_Fusobacterium _
_necrophorum. _
Treatment of acute ovine mastitis caused by
_Staphylococcus aureus _
and
_Mycoplasma _
_agalactiae_
.
4.3
CONTRAINDICATIONS
Do not administer intravenously.
Do not administer intramuscularly
Do not administer to lambs weighing less than 15 kg.
Do not administer to primates.
Do not administer to pigs.
Do not administer to horses and donkeys.
3
Do not administer to goats.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
SHEEP
The clinical trials did not demonstrate a bacteriological cure in
sheep with acute mastitis caused
by
_Staphylococcus aureus _
and
_Mycoplasma agalactiae. _
Accurate weighing of lambs is important to avoid overdose.
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
(regional, farm level)
epidemiological information about susceptibility of the target
bacteria.
Use of the product deviating from the instructions given in the SPC
may increase the prevalence
of bacteria resis