产品特点
1
_[Version 7.3.2, 10/2011] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PHARMASIN 200 mg/ml solution for injection for cattle, sheep, goats and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Tylosin 200 000 IU/ml
Excipients:
Benzyl alcohol (E1519) 40 mg/ml.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A pale yellow to amber-coloured liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, sheep, goats, pigs.
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES)
Infections caused my microorganisms susceptible to tylosin.
CATTLE (ADULT):
-
Treatment of respiratory infections, metritis caused by Gram-positive
micro-organisms, mastitis caused by _Streptococcus_ spp., _Staphylococcus_ spp.
or _Mycoplasma_ and interdigital necrobacillosis”, i.e. panaritum or foot rot.
CALVES:
-
Treatment of respiratory infections and necrobacillosis.
PIGS:
-
Treatment of enzootic pneumonia, haemorrhagic enteritis, erysipelas and
metritis.
-
Treatment of arthritis caused by _Mycoplasma_ and _Staphylococcus_ spp.
SHEEP AND GOATS:
Treatment of respiratory infections, metritis caused by Gram-positive
3
microorganisms, mastitis caused by Gram+ microorganisms or _Mycoplasma _spp.
4.3
CONTRAINDICATIONS
Do not administer to horses. Intramuscular injection can be fatal in chickens and
turkeys.
Do not administer to animals with a known hypersensitivity to tylosin or other
macrolides.
4.4
SPE
阅读完整的文件