M+PAC

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Inactivated mycoplasma hyopneumoniae

זמין מ:

Intervet Ireland Limited

קוד ATC:

QI09AB13

INN (שם בינלאומי):

Inactivated mycoplasma hyopneumoniae

כמות:

1.47-4.24 Relative potency

טופס פרצבטיות:

Emulsion for injection

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

קבוצה תרפויטית:

Pigs

איזור תרפויטי:

mycoplasma

סממני תרפויטית:

Immunological - Inactivated vaccine

מצב אישור:

Authorised

תאריך אישור:

2002-09-12

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
M+PAC.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Emulsion for injection.
[White liquid emulsion]
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pig (fattening pigs, from 7 days of age).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For
the active immunization of
pigs
in order
to reduce frequency and severity of
lung lesions
caused by_ Mycoplasma_
_hyopneumoniae._
For vaccination with 2 doses of 1 ml given 2-4 weeks apart,
protection has been demonstrated 35 days post initial dose and the
duration of immunity is at least 6 months. In field studies, only
seroconversion has been demonstrated in pigs receiving two 1 ml
doses.
For vaccination with 1 dose of 2 ml, protection has been shown 24 days
after vaccination and duration of immunity is at least 6
months after vaccination.
4.3 CONTRAINDICATIONS
None.
Active ingredients:
Quantity per 1 ml volume
_Mycoplasma hyopneumoniae_, inactivated
1.47 RPU (*)
Light mineral oil
0.134 ml
Aluminium (as hydroxide)
1.0 mg
Thiomersal
0.10 mg
Excipients
qs
1.0 ml
For full list of excipients, see section 6.1
(*) Relative Unit defined against a reference vaccine
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4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Piglets vaccinated from 7 days of age :
Under laboratory con