Ingelvac M. hyo
Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: HMA (Heads of Medicines Agencies)
Lietošanas instrukcija
(PIL)
20-03-2013
Produkta apraksts
(SPC)
20-03-2013
Pieejams no:
SCS Boehringer Ingelheim
ATĶ kods:
QI09AB13
Zāļu forma:
Emulsion for injection
Ārstniecības grupa:
Mycoplasma vaccine
Ārstniecības joma:
Pigs Food
Autorizācija datums:
2011-11-24
Lietošanas instrukcija
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ingelvac M. hyo emulsion for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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
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
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
3
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. Injections with Ingelvac M. hyo done improperly can cause injection site lesions, such as
granulomas or abscesses.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL
PRODUCT TO ANIMALS
Self inje
Izlasiet visu dokumentu
Produkta apraksts
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ingelvac M. hyo emulsion for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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
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
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
3
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. Injections with Ingelvac M. hyo done improperly can cause injection site lesions, such as
granulomas or abscesses.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL
PRODUCT TO ANIMALS
Self inje
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