Ingelvac M. hyo emulsion for injection for pigs

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Mycoplasma hyopneumoniae, J strain, isolate B-3745, Mycoplasma hyopneumoniae

Disponibbli minn:

Boehringer Ingelheim Ltd

Kodiċi ATC:

QI09AB13

INN (Isem Internazzjonali):

Mycoplasma hyopneumoniae, J strain, isolate B-3745, Mycoplasma hyopneumoniae

Dożaġġ:

3.0x10^8 - 6.0*x10^8, 1:80 colour changing units/dose

Għamla farmaċewtika:

Emulsion for injection

Tip ta 'preskrizzjoni:

LM: Licensed Merchant as defined in relevant national legislation

Grupp terapewtiku:

Pigs

Żona terapewtika:

mycoplasma

Indikazzjonijiet terapewtiċi:

Immunological - Inactivated Vaccine

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2002-07-04

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ingelvac M. hyo emulsion for injection for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Emulsion for injection. White opaque emulsion.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Fattening pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of pigs from 3 weeks of age to reduce lung
lesions following infection with_ Mycoplasma_
_hyopneumoniae._
Onset of protection occurs by two weeks post vaccination and lasts for
at least 118 days.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Inactivated whole culture of_ Mycoplasma hyopneumoniae_, J Strain,
Isolate B-3745 grown in liquid medium
One dose of 2 ml vaccine contains:
ACTIVE SUBSTANCE:
_MYCOPLASMA HYOPNEUMONIAE_:
1 : 80*
*antibody titre elicited with ½ dose (rabbits/ELISA assay)
ADJUVANT:
Montanide ISA 708:
1.30 ml (65 %)
EXCIPIENTS
For a complete list of excipients, see section 6.1
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Vaccinate only clinically healthy animals.
In case of anaphylactic reactions, the administration of epinephrine
is recommended.
The application of the vaccine should be performed according to the
requirements of Good Veterinary Practice.