Micotil 300 mg/ml Solution for Injection

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

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Hent Produktets egenskaber (SPC)
12-06-2017

Aktiv bestanddel:

Tilmicosin

Tilgængelig fra:

Elanco Animal Health, Eli Lilly and Company Limited

ATC-kode:

QJ01FA91

INN (International Name):

Tilmicosin

Dosering:

300 milligram(s)/millilitre

Lægemiddelform:

Solution for injection

Recept type:

VPO: Veterinary Practitioner Only as defined in relevant national legislation

Terapeutisk gruppe:

Bovine, Ovine

Terapeutisk område:

tilmicosin

Terapeutiske indikationer:

Antibacterial

Autorisation status:

Authorised

Autorisation dato:

1990-09-26

Produktets egenskaber

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Micotil 300 mg/ml Solution for Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE
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 case of hypersensitivity to the active substance or to
any of the excipients.
Tilmicosin 300 mg
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4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
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