TYLUCYL 200 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-05-2016
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Active ingredient:
TYLOSIN
Available from:
Vetoquinol UK Limited
ATC code:
QJ01FA90
INN (International Name):
TYLOSIN
Dosage:
200 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine, Porcine
Therapeutic area:
Tylosin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2016-05-06
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tylucyl 200 mg/ml solution for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
Active ingredient(s):
Tylosin............................................................................................. 200 000 IU (equivalent to approximately 200 mg)
Excipient(s):
Benzyl alcohol (E1519) ................................................................................... 40 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Pale yellow to amber coloured solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of specific infections (stated below) caused by microorganisms susceptible to tylosin.
Cattle (adult):
-Respiratory infections, metritis caused by Gram-positive microorganisms, mastitis caused by _Streptococcus _spp.,
_Staphylococcus _spp. or _Mycoplasma _spp. and interdigital necrobacillosis, i.e. panaritium or foot root.
Calves:
-Respiratory infections and necrobacillosis.
Pigs (more than 25 kg):
-Enzootic pneumonia, haemorrhagic enteritis, erysipelas and metritis.
-Arthritis caused by _Mycoplasma _spp. and _Staphylococcus _spp.
For information regarding swine dysentery see section 4.5.
4.3 CONTRAINDICATIONS
Do not administer to horses.
Intramuscular injection can be fatal in chickens and turkeys.
Do not administer to animals with known hypersensitivity to tylosin, other macrolides or to any of the excipients.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 06/05/2016_
_CRN 7019994_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5 SPECIAL PRECAUTIONS FOR
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