Milbotyl 300 mg/ml solution for injection

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Tilmicosin

Boleh didapati daripada:

Chanelle Pharmaceuticals Manufacturing Limited

Kod ATC:

QJ01FA91

INN (Nama Antarabangsa):

Tilmicosin

Dos:

300 milligram(s)/millilitre

Borang farmaseutikal:

Solution for injection

Jenis preskripsi:

POM: Prescription Only Medicine as defined in relevant national legislation

Kumpulan terapeutik:

Cattle, Sheep

Kawasan terapeutik:

tilmicosin

Tanda-tanda terapeutik:

Antibacterial

Status kebenaran:

Authorised

Tarikh kebenaran:

2009-11-25

Ciri produk

Health Products Regulatory Authority
20 March 2018
CRN000VJS
Page 1 of 9
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Milbotyl 300 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Tilmicosin 300 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, yellowish to brown-yellowish solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle
For the treatment of bovine respiratory disease associated with
_Mannheimia _
_haemolytica_ and_ Pasteurella multocida._
For the treatment of interdigital necrobacillosis.
Sheep
For the 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.
Health Products Regulatory Authority
20 March 2018
CRN000VJS
Page 2 of 9
Do not administer to pigs.
Do not administer to horses and donkeys.
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._
Do not administer to lambs weighing less than 15 kg, since there is a
real risk of
overdosage toxicity. Accurate weighing of lambs is important to avoid
overdosage.
The use of a 2 ml or smaller syringe will improve 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 pr