ReproCyc ParvoFLEX Suspension for Injection for Pigs

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: VMD (Veterinary Medicines Directorate)

সক্রিয় উপাদান:

Porcine parvovirus 27a viral protein 2

থেকে পাওয়া:

Boehringer Ingelheim Vetmedica Gmbh

এটিসি কোড:

QI09AA02

INN (আন্তর্জাতিক নাম):

Porcine parvovirus 27a viral protein 2

ফার্মাসিউটিকাল ফর্ম:

Suspension for injection

প্রেসক্রিপশন টাইপ:

POM-V - Prescription Only Medicine – Veterinarian

থেরাপিউটিক গ্রুপ:

Pigs

থেরাপিউটিক এলাকা:

Inactivated Viral Vaccine

অনুমোদন অবস্থা:

Authorized

অনুমোদন তারিখ:

2019-05-22

পণ্য বৈশিষ্ট্য

Unlimited Renewal: December 2023
AN: 02436/2023
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
ReproCyc ParvoFLEX suspension for injection for pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
ACTIVE SUBSTANCE:
Porcine Parvovirus strain 27a VP2 subunit antigen ≥ 1.0 RP*
*
Relative Potency (ELISA)
ADJUVANT:
Carbomer 2 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection.
Colourless to slightly brown, opalescent suspension.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of gilts and sows from the age of 5 months to
protect
progeny against transplacental infection caused by porcine parvovirus.
Onset of immunity:
from the beginning of the gestational
period. Duration of immunity:
6 months
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Unlimited Renewal: December 2023
AN: 02436/2023
Page 2 of 5
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
Not applicable.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Transient redness or swelling (up to 4 cm) caused by the injection
procedure is very
common. Local reactions resolve within two to five days without
treatment. An
elevation in the body temperature after vaccination is common which
resolves
spontaneously within 24 to 48 hours.
The frequency of adverse reactions is defined using the following
convention:
-
very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
-
common (more than 1 but less than 10 animals in 100 animals treated)
-
uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
-
rare (more than 1 but less than 10 animals in 10,000 animals treated)
-
very rare (less than 1 animal in 10,000 animals treated , including
isolated