Porcilis M Hyo, Suspension for Injection

ประเทศ: สหราชอาณาจักร

ภาษา: อังกฤษ

แหล่งที่มา: VMD (Veterinary Medicines Directorate)

สารออกฤทธิ์:

Mycoplasma hyopneumoniae

มีจำหน่ายจาก:

MSD Animal Health UK Limited

รหัส ATC:

QI09AB13

INN (ชื่อสากล):

Mycoplasma hyopneumoniae

แบบฟอร์มเภสัชกรรม:

Suspension for injection

ประเภทใบสั่งยา:

POM-V - Prescription Only Medicine – Veterinarian

กลุ่มบำบัด:

Pigs

พื้นที่บำบัด:

Inactivated Bacterial Vaccine

สถานะการอนุญาต:

Authorized

วันที่อนุญาต:

2006-03-31

สรุปลักษณะสินค้า

Revised: June 2020
AN: 00218/2020
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis M Hyo, suspension for injection
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
Revised: June 2020
AN: 00218/2020
Page 2 of 4
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 from 4 wee