Porcilis M Hyo, Suspension for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Mycoplasma hyopneumoniae

Available from:

Intervet International BV

ATC code:

QI09AB13

INN (International Name):

Mycoplasma hyopneumoniae

Pharmaceutical form:

Suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Inactivated Bacterial Vaccine

Authorization status:

Authorized

Authorization date:

2006-03-31

Summary of Product characteristics

Revised: March 2011
Amended pages
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis M Hyo, suspension for injection;
IT: Porsilis M Hyo
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
per dose of 2 ml
ACTIVE SUBSTANCE
Inactivated whole cell concentrate of _Mycoplasma hyopneumoniae_
strain 11:

7.0 log
2
Ab titre*
Adjuvant: 150 mg dl-

-tocopheryl acetate
* Mean antibody titre (Ab) obtained after inoculation of mice with a
1/20 pig dose.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection; white or nearly white
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pig (finishing pigs)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For finishing pigs:
For the active immunisation of pigs to reduce pulmonary lesions due to
infection by
_Mycoplasma hyopneumoniae. _
Onset of immunity: 2 weeks after the second injection
Duration of immunity: at least 20 weeks after the second injection.
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS
None
Page 1 of 4
Revised: March 2011
Amended pages
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Vaccinate only healthy animals.
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
In case of accidental self-injection, seek medical advice immediately
and show
the package leaflet or the label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A mean transient temperature increase in body temperature of about 0.3

C, in
individual pigs up to 2.0

C, may occur on the first 1 to 2 days after vaccination. The
animals return to normal the next day. A transient swelling/redness
(max. diameter 5
cm) may occur at the injection site diminishing over a period of
maximally 14 days.
In isolated cases hypersensitivity reactions may occur.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Not applicable
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Safety and efficacy data are available in pigs fr