Micotil 300 mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tilmicosin

Available from:

Elanco GmbH

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 area:

tilmicosin

Authorization status:

Authorised

Authorization date:

1990-09-26

Summary of Product characteristics

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