STELLAMUNE MYCOPLASMA

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Mycoplasma hyopneumoniae strain p-5722-3

זמין מ:

Elanco Animal Health, Eli Lilly and Company Limited

קוד ATC:

QI09AB13

INN (שם בינלאומי):

Mycoplasma hyopneumoniae strain p-5722-3

כמות:

Not Currently Available

טופס פרצבטיות:

Emulsion for injection

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

קבוצה תרפויטית:

Pigs

איזור תרפויטי:

mycoplasma

סממני תרפויטית:

Immunological

מצב אישור:

Authorised

תאריך אישור:

2011-01-07

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
STELLAMUNE MYCOPLASMA
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose contains
ACTIVE SUBSTANCE
Inactivated_ Mycoplasma hyopneumoniae_
at least 10,529 RU* at release to ensure 6000 RU* throughout
shelf-life.
* = Relative ELISA Units
ADJUVANTS
Liquid paraffin
0.09 ml
EXCIPIENTS
Thiomersal
0.185 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Emulsion for injection
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Fattening pigs from one week of age.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of fattening pigs to reduce lung lesion scores
caused by_ Mycoplasma hyopneumoniae_
infection. Protection against_ Mycoplasma hyopneumoniae_ reduces the
impact of secondary bacterial infection with
_Pasteurella multocida_, offering improved health and economic
benefits. Immunity is acquired two weeks following the
second vaccination and protection lasts throughout the fattening
period.
4.3 CONTRAINDICATIONS
The use of immunosuppressant drugs or procedures is contraindicated
within one month of vaccination.
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4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate only healthy animals.
In any animal population, a small number of individuals may fail to
respond fully to vaccinat