Milbotyl 300 mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tilmicosin

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QJ01FA91

INN (International Name):

Tilmicosin

Dosage:

300 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Sheep

Therapeutic area:

tilmicosin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2009-11-25

Summary of Product characteristics

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