Bovalto Respi 3 Suspension for Injection for Cattle

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: VMD (Veterinary Medicines Directorate)

সক্রিয় উপাদান:

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus, Mannheimia haemolytica

থেকে পাওয়া:

Boehringer Ingelheim Animal Health UK Ltd

এটিসি কোড:

QI02AL

INN (আন্তর্জাতিক নাম):

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus, Mannheimia haemolytica

ফার্মাসিউটিকাল ফর্ম:

Suspension for injection

প্রেসক্রিপশন টাইপ:

POM-V - Prescription Only Medicine – Veterinarian

থেরাপিউটিক গ্রুপ:

Cattle

থেরাপিউটিক এলাকা:

Inactivated Viral and Bacterial Vaccine

অনুমোদন অবস্থা:

Authorized

অনুমোদন তারিখ:

2016-02-17

পণ্য বৈশিষ্ট্য

Revised: June 2020
AN: 01561/2019
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BOVALTO Respi 3 suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (2 ml) contains:
ACTIVE SUBSTANCES:
Inactivated bovine respiratory syncytial virus, strain BIO-24
RP*

1
Inactivated bovine parainfluenza 3 virus, strain BIO-23
RP*

1
Inactivated_ Mannheimia haemolytica_, serotype A1 strain DSM 5283
RP*

1
* Relative potency (RP) in comparison with the reference serum
obtained after
vaccination of guinea pigs with a vaccine batch that has successfully
passed the
challenge test in the target animals.
ADJUVANTS:
Aluminium hydroxide
8.0 mg
Quillaja saponin (Quil A)
0.4 mg
EXCIPIENTS:
Thiomersal
0.2 mg
Formaldehyde
1.0 mg at most.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Appearance: pinkish liquid with sediment.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of cattle in the absence of maternally derived
antibodies
against:
- parainfluenza 3 virus, to reduce virus excretion due to infection,
- bovine respiratory syncytial virus, to reduce virus excretion due to
infection,
- _Mannheimia_ _haemolytica_ serotype A1, to reduce clinical signs and
lung lesions.
Onset of immunity: 3 weeks.
Duration of immunity: 6 months.
Revised: June 2020
AN: 01561/2019
Page 2 of 5
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Safety and efficacy studies were performed in sero-negative calves.
The efficacy of
the vaccination has not been demonstrated in presence of antibodies.
The level of
antibody response may be reduced by the presence of maternal
antibodies. In the
presence of maternal antibodies, timing of initial vaccination of
calves should be
planned accordingly.
Special precautions to be taken by the person