Micotil 300 mg/ml Solution for Injection

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Tilmicosin

Tersedia dari:

Elanco GmbH

Kode ATC:

QJ01FA91

INN (Nama Internasional):

Tilmicosin

Dosis:

300 milligram(s)/millilitre

Bentuk farmasi:

Solution for injection

Jenis Resep:

POM: Prescription Only Medicine as defined in relevant national legislation

Area terapi:

tilmicosin

Status otorisasi:

Authorised

Tanggal Otorisasi:

1990-09-26

Karakteristik produk

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Micotil 300 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Tilmicosin 300 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear solution.
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.
Do not administer to goats.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
SHEEP
3
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
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.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken
into account when the product is
used.
To avoid self-injection do not use automatic injection equipment.
Wherever possible, the use of the product should be based on
susceptibility testing.
Special precautions to be