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

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Tilmicosin

Disponible des:

Emdoka

Codi ATC:

QJ01FA91

Designació comuna internacional (DCI):

Tilmicosin

Dosis:

300 milligram(s)/millilitre

formulario farmacéutico:

Solution for injection

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Cattle, Sheep

Área terapéutica:

tilmicosin

indicaciones terapéuticas:

Antibacterial

Estat d'Autorització:

Authorised

Data d'autorització:

2011-04-21

Fitxa tècnica

1. NAME OF THE VETERINARY MEDICINAL PRODUCT
TILMODIL 300 mg/ml Solution for Injection for cattle and sheep
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Tilmicosin 300 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT
INFORMATION IS ESSENTIAL
FOR PROPER
ADMINISTRATION OF THE VETERINARY MEDICINAL
PRODUC
t
_ _
Propylene glycol
250 mg
Phosphoric acid (for pH adjustment)
Water for injections
Clear, yellowish to brown-yellowish solution.
_ _
3. CLINICAL PARTICULARS
3.1 TARGET SPECIES
Cattle and sheep.
3.2 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_
.
3.3 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.
Do not administer to goats.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
3.4 SPECIAL WARNINGS
SHEEP:
The clinical trials did not demonstrate a bacteriological cure in
sheep with acute mastitis
caused by
_Staphyloccocus aureus _
and
_Mycoplasma agalactiae._
_ _
Do not administer to lambs weighing less than 15 kg, since there is a
real risk of overdose
toxicity.
Accurate weighing of lambs is important to avoid overdose. The use of
a 2 ml or smaller
syringe will facilitate accurate dosing.
3.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Official, national and regional a