TYLOJECT 200 MG/ML SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
TYLOSIN TARTRATE
Available from:
Franklin Pharmaceuticals Ltd.
ATC code:
QJ01FA90
Dosage:
200 Mg/Ml
Pharmaceutical form:
Solution for Injection
Therapeutic group:
Antibacterial
Therapeutic area:
Porcine
Authorization date:
1988-10-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tyloject 200 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is specifically formulated for the treatment and prevention of infections caused by organisms sensitive to
Tylosin e.g. _Spirochaetes, Leptospira, Actinomyces, Mycoplasmas, Haemophilus pertussis. Moraxella bovis,_
_Streptococci spp., Neissieria spp_. and some Gram negative bacteria. It is also effective against some _Mycoplasmas,_
_Chlamydiae _and _Rickettsiae._
The product is recommended for use in the treatment of a wide range of common respiratory and genito-urinary tract,
otitis, cellulitis and secondary bacterial conditions associated with viral disease or postoperative infections in pigs.
4.3 CONTRAINDICATIONS
Do not use in very young animals. This product contains Benzyl Alcohol, which has been documented to cause adverse
reactions in neonates.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Oedema of the anal mucosa, partial anal protrussion, erythema and prutitis have occasionally been reported following
medication in pigs. This product contains Benzyl Alcohol which has been documented to cause adverse reactions in
neonates. Hence the product should not be used in young animals.
Each ml contains:
Active substance
Tylosin tartrate
200 mg
Excipients
Benzyl alcohol
10 mg
For a full list of excipients, see section 6.1.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/04/2011_
_CRN 7010617_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR US
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