Stellamune Once

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Mycoplasma hyopneumoniae inactivated , strain nl1042

Disponible depuis:

Elanco GmbH

Code ATC:

QI09AB13

DCI (Dénomination commune internationale):

Mycoplasma hyopneumoniae inactivated , strain nl1042

Dosage:

.

forme pharmaceutique:

Emulsion for injection

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Domaine thérapeutique:

mycoplasma

Statut de autorisation:

Authorised

Date de l'autorisation:

2010-11-26

Résumé des caractéristiques du produit

Health Products Regulatory Authority
20 July 2018
CRN000YKD
Page 1 of 5
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.
Health Products Regulatory Authority
20 July 2018
CRN000YKD
Page 2 of 5
Duration of immunity: 23 weeks following vaccination.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
To the user:
This product contains mineral oil. Accidental injection/self injection
may result in
severe pain and swelling, particularly if injected into a joint or
finger, and in rare
cases could result in the loss of the affected finger if prompt
medical attention is not
given.
If you are accidentally injected with this product seek prompt medical
advice even if
only a very small amount is injected and take the pac