Bovilis BVD Suspension for injection for cattle

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Inactivated antigen of cytopathogenic BVDV strain C-86

Saatavilla:

Intervet Ireland Limited

ATC-koodi:

QI02AA01

INN (Kansainvälinen yleisnimi):

Inactivated antigen of cytopathogenic BVDV strain C-86

Annos:

.

Lääkemuoto:

Suspension for injection

Prescription tyyppi:

POM (E): Prescription Only Exempt as defined in relevant national legislation

Terapeuttinen ryhmä:

Cattle

Terapeuttinen alue:

bovine viral diarrhea (BVD)

Käyttöaiheet:

Immunological - Inactivated Vaccine

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

1999-08-30

Valmisteyhteenveto

Health Products Regulatory Authority
07 August 2020
CRN009WSS
Page 1 of 4
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 COMPONENT:
Inactivated cytopathogenic bovine viral diarrhea (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.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
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
In the case of accidental self-injection, seek medical advice
immediately and show the package leaflet or the label to the
physician.
Health Products Regulatory Authority
07 August 2020
CRN009WSS
Page 2 of 4
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 followin