MICOTIL 300MG/ML SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
29-05-2024
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Active ingredient:
TILMICOSIN
Available from:
Elanco Animal Health, Eli Lilly and Company Limited
ATC code:
QJ01FA91
Dosage:
300 Mg/Ml
Pharmaceutical form:
Solution for Injection
Therapeutic group:
Antibacterial
Therapeutic area:
Bovine
Authorization date:
1990-09-26
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Micotil 300mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a 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
For the treatment of pneumonia in cattle and sheep, associated with _Mannheimia haemolytica, Pasteurella multocida_
and other micro-organisms sensitive to tilmicosin. For the treatment of ovine mastitis associated with _Staphylococcus_
aureus and _Mycoplasma agalactiae_. As an aid in the control of outbreaks of enzootic abortion in ewes caused by
_Chlamydia psittaci_. For the treatment of interdigital necrobacillosis in cattle (bovine pododermatitis, foul in the foot).
4.3 CONTRAINDICATIONS
Do not administer intravenously.
Do not use in cattle producing milk for human consumption.
Do not administer to pigs.
Do not administer to horses.
Do not administer to goats.
Do not administer to monkeys.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
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 facilitate accurate
dosing.
Each ml contains:
Active Substance
Tilmicosin
300 mg
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 19/04/2011_
_CRN 7010568_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not administer intravenously.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
INJECTION OF
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