Tilmodil 300 mg/ml Solution for Injection for Cattle and Sheep

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Tilmicosin

Available from:

Emdoka bvba

ATC code:

QJ01FA91

INN (International Name):

Tilmicosin

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Sheep

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2011-04-20

Summary of Product characteristics

Revised: June 2016
AN: 00650/2015
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Tilmodil 300 mg/ml Solution for Injection for cattle and sheep
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Tilmicosin 300 mg
EXCIPIENT:
Propylene glycol 250 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, yellowish to brown-yellowish solution (pH=6).
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.
Revised: June 2016
AN: 00650/2015
Page 2 of 8
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.
4.4SPECIAL WARNINGS FOR EACH TARGET SPECIES
SHEEP:
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
real 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