Porcilis PCV Emulsion for Injection for Pigs

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Viambatanisho vya kazi:

Porcine circovirus-2

Inapatikana kutoka:

MSD Animal Health UK Limited

ATC kanuni:

QI09AA07

INN (Jina la Kimataifa):

Porcine circovirus-2

Dawa fomu:

Emulsion for injection

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Pigs

Eneo la matibabu:

Inactivated Viral Vaccine

Idhini hali ya:

Authorized

Idhini ya tarehe:

2009-01-12

Tabia za bidhaa

Issued: September 2021
AN: 01782/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis PCV emulsion for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
ACTIVE SUBSTANCE:
Porcine circovirus type 2 ORF2 subunit antigen: ≥3720 AU*
* Antigenic Units as determined in the _in vitro_ potency test
(AlphaLISA).
ADJUVANTS:
Dl-α-tocopheryl acetate 25 mg
Light liquid paraffin
346 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
Opalescent white, with brown resuspendable sediment.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of pigs to reduce the virus load in blood
and lymphoid
tissues and to reduce mortality and weight loss associated with PCV2
infection
occurring during the fattening period.
Onset of immunity:
2 weeks
Duration of immunity: 22 weeks.
4.3
CONTRAINDICATIONS
None
Issued: September 2021
AN: 01782/2020
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
From the data provided, it can be concluded that a single dose regimen
of
vaccination breaks through up to medium levels and double dose regimen
through
medium to high levels of maternally derived antibodies in piglets.
No data are available on the use of the vaccine in breeding boars.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinate only healthy animals.
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
tak