STELLAMUNE ONCE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MYCOPLASMA HYOPNEUMONIAE INACTIVATED , STRAIN NL1042

Available from:

Elanco Animal Health, Eli Lilly and Company Limited

ATC code:

QI09AB13

INN (International Name):

MYCOPLASMA HYOPNEUMONIAE INACTIVATED , STRAIN NL1042

Pharmaceutical form:

Emulsion for Injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Pigs

Therapeutic area:

mycoplasma

Therapeutic indications:

Immunological - Inactivated vaccine

Authorization status:

Authorised

Authorization date:

2010-11-26

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Stellamune Once.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per 2 ml dose:
Active substance:
Inactivated_ Mycoplasma hyopneumoniae,_ strain NL1042, between 4.5 and
5.2 log10 units*.
*ELISA Relative Potency Units by comparison with a reference vaccine.
Adjuvant:
Amphigen Base
0.025 ml
Drakeol 5 (Mineral oil)
0.075 ml.
Excipients:
Thiomersal
0.185 mg
For a full list of exipients, see section 6.1
3 PHARMACEUTICAL FORM
Emulsion for injection.
Off white, translucent, semi turbid oil in water emulsion.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Fattening pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of piglets from 3 days of age to reduce lung
lesions related to infection by_ Mycoplasma_
_hyopneumoniae_ in fattening animals.
Onset of immunity: 18 days following vaccination.
Duration of immunity: 26 weeks following vaccination.
For
active immunisation of
piglets from 3 weeks of
age to reduce coughing and losses in weight
gain related to
infection by_ Mycoplasma hyopneumoniae_ in fattening animals.
Onset of immunity: 3 weeks following vaccination.
Duration of immunity: 23 weeks following vaccination.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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4.5 SPECIAL P