Porcilis PCV Emulsion for Injection for Pigs

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: VMD (Veterinary Medicines Directorate)

সক্রিয় উপাদান:

Porcine circovirus-2

থেকে পাওয়া:

MSD Animal Health UK Limited

এটিসি কোড:

QI09AA07

INN (আন্তর্জাতিক নাম):

Porcine circovirus-2

ফার্মাসিউটিকাল ফর্ম:

Emulsion for injection

প্রেসক্রিপশন টাইপ:

POM-V - Prescription Only Medicine – Veterinarian

থেরাপিউটিক গ্রুপ:

Pigs

থেরাপিউটিক এলাকা:

Inactivated Viral Vaccine

অনুমোদন অবস্থা:

Authorized

অনুমোদন তারিখ:

2009-01-12

পণ্য বৈশিষ্ট্য

Revised: April 2024
AN: 00332/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis PCV emulsion for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose 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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Revised: April 2024
AN: 00332/2023
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals:
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.
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 veterinary
medicinal product, seek prompt medical advice even if only a very
small amount is
in