Micotil 300 mg/ml Solution for Injection

Summary of Product characteristics

                                Revised May 2020
AN: 01516/2019
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:
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.
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Revised May 2020
AN: 01516/2019
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
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
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 possib
                                
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