Bovilis BVD Suspension for Injection for Cattle

Country: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Bovine viral diarrhoea virus

Fáanlegur frá:

MSD Animal Health UK Limited

INN (Alþjóðlegt nafn):

Bovine viral diarrhoea virus

Lyfjaform:

Suspension for injection

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Cattle

Lækningarsvæði:

Inactivated Viral Vaccine

Leyfisstaða:

Authorized

Leyfisdagur:

1999-06-25

Vara einkenni

Revised: July 2020
AN: 00083/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis BVD
Suspension for injection for cattle.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
ACTIVE SUBSTANCE:
Inactivated cytopathogenic bovine viral diarrhoea (BVD) virus type 1
strain C-86,
containing 50 ELISA Units (EU) and inducing at least 4.6 log
2
VN units*
*Mean virus neutralizing titre obtained in the potency test
ADJUVANT:
Aluminium 3+ (as Al-phosphate and Al-hydroxide): 6-9 mg
EXCIPIENTS:
Methyl parahydroxybenzoate: 3 mg (preservative)
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection.
Red to pink-coloured turbid suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (cows and heifers).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of cows and heifers from eight months of age
onwards to protect
the foetus against transplacental infection with bovine viral
diarrhoea virus.
4.3
CONTRAINDICATIONS
None.
Revised: July 2020
AN: 00083/2020
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTION 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
In the case of accidental self-injection, seek medical advice
immediately and show the
package leaflet or the label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In very rare cases a slight swelling may be observed for 14 days at
the site of injection.
Also in very rare cases transient mild pyrexia may occur. In very rare
cases,
hypersensitivity reactions including anaphylactic shock may occur. In
the event of
anaphylactic type reactions, appropriate treatment such as with
antihistamine,
corticosteroid or adrenaline is recommended.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 a