STELLAMUNE MYCOPLASMA

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Mycoplasma hyopneumoniae strain p-5722-3

MAH:

Elanco Animal Health, Eli Lilly and Company Limited

ATC_code:

QI09AB13

INN:

Mycoplasma hyopneumoniae strain p-5722-3

dosage:

Not Currently Available

pharmaceutical_form:

Emulsion for injection

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_group:

Pigs

therapeutic_area:

mycoplasma

therapeutic_indication:

Immunological

authorization_status:

Authorised

authorization_date:

2011-01-07

SPC

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