Porcilis M Hyo ID Once Emulsion for Injection for Pigs

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

Aktivna sestavina:

Mycoplasma hyopneumoniae

Dostopno od:

MSD Animal Health UK Limited

Koda artikla:

QI09AB13

INN (mednarodno ime):

Mycoplasma hyopneumoniae

Farmacevtska oblika:

Emulsion for injection

Tip zastaranja:

POM-V - Prescription Only Medicine – Veterinarian

Terapevtska skupina:

Pigs

Terapevtsko območje:

Inactivated Bacterial Vaccine

Status dovoljenje:

Authorized

Datum dovoljenje:

2012-01-24

Lastnosti izdelka

Revised: August 2020
AN: 00299/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis M Hyo ID ONCE emulsion for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of 0.2 ml contains:
ACTIVE SUBSTANCE:
Inactivated whole cell concentrate of _ Mycoplasma hyopneumoniae_
strain 11:

6.5
log
2
Ab titre*
* Mean antibody titre (Ab) obtained after inoculation of mice with a
1/1,000 pig dose.
ADJUVANT:
light liquid paraffin
34.6 mg
dl-

-tocopheryl acetate
2.5 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
White to nearly white emulsion with creamy appearance after shaking.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (finishing pigs).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of finishing pigs to reduce pulmonary
lesions and the
decrease in daily weight gain during the finishing period due to
infection caused by
_Mycoplasma hyopneumoniae_.
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 22 weeks after vaccination.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Revised: August 2020
AN: 00299/2020
Page 2 of 5
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
To the user:
This veterinary medicinal product contains mineral oil. Accidental
injection/self-
injection may result in severe pain and swelling, particularly if
injected into a joint or
finger, and in rare cases could result in the loss of the affected
finger if prompt
medical attention is not given. If you are accidentally injected with
this product, seek
prompt medical advice even if only a very small amount is injected and
take the
package leaflet with you. If pain persists for more than 12 hours
after medical
examination, seek medical advice again.
To the physician: