MILBOTYL 300 MG/ML SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
23-06-2015
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
TILMICOSIN
Available from:
Chanelle Pharmaceuticals Manufacturing Limited
ATC code:
QJ01FA91
INN (International Name):
TILMICOSIN
Dosage:
300 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
VPO-Vet.Practitioner Only
Therapeutic group:
Bovine, Ovine
Therapeutic area:
Tilmicosin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2009-11-25
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Milbotyl 300 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Tilmicosin
300 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle
For the treatment of bovine respiratory disease associated with _Mannheimia haemolytica _and _Pasteurella multocida._
For the treatment of interdigital necrobacillosis.
Sheep
For the 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_.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 08/06/2015_
_CRN 7018022_
_page number: 1_
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 _Staphylococcus_
_aureus _and _Mycoplasma agalactiae._
Do not administer to lambs weighing less than 15 kg, since there is a real risk of overdosage toxicity. Accurate
weighing of
Read the complete document
