Hymatil 300 mg/ml solution for injection for cattle and sheep

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Tilmicosin

Fáanlegur frá:

Industrial Veterinaria, S.A.

ATC númer:

QJ01FA91

INN (Alþjóðlegt nafn):

Tilmicosin

Skammtar:

300 milligram(s)/millilitre

Lyfjaform:

Solution for injection

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Cattle, Sheep

Lækningarsvæði:

tilmicosin

Ábendingar:

Antibacterial

Leyfisstaða:

Authorised

Leyfisdagur:

2010-12-17

Vara einkenni

Health Products Regulatory Authority
18 June 2019
CRN0094DC
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Hymatil 300 mg/ml solution for injection for cattle and sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Tilmicosin..............................................................
300 mg
EXCIPIENTS:
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.
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.
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 _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.
Health Products Regulatory Authority
18 June 2019
CRN0094DC
Page 2 of