HIPRABOVIS-4

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Inactivated infectious bovine rhinotracheitis virus strain LA; Inactivated parainfluenza-3 virus, strain SF4; Inactivated bovine diarrhoea virus strain NADL; Live bovine respiratory strain lym-56

Fáanlegur frá:

Laboratorios Hipra S.A.

ATC númer:

QI02AH

INN (Alþjóðlegt nafn):

Inactivated infectious bovine rhinotracheitis virus strain LA; Inactivated parainfluenza-3 virus, strain SF4; Inactivated bovine diarrhoea virus strain NADL; Live bovine respiratory strain lym-56

Skammtar:

- percent

Lyfjaform:

Powder and solvent for suspension for injection

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Cattle

Lækningarsvæði:

Live and inactivated viral vaccines

Ábendingar:

Immunological - Mixed Vaccine (L & A)

Leyfisstaða:

Authorised

Leyfisdagur:

2003-06-06

Vara einkenni

Health Products Regulatory Authority
17 June 2019
CRN0094D9
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
HIPRABOVIS-4
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Composition per dose (3 ml) of vaccine: ​
​
Inactivated Infectious Bovine Rhinotracheitis Virus (IBR), strain LA
​
≥ 10
7
TCID
50
​
Inactivated Parainfluenza-3 Virus (PI3), strain SF4
​
≥ 480 HAU
​
Inactivated Bovine Diarrhoea Virus (BVD), strain NADL
​
≥ 10
6
TCID
50
​
Live Bovine Respiratory Syncytial Virus, strain Lym-56
​
≥ 10
5
TCID
50
​
Adjuvant
​
​
Aluminium hydroxide gel (as Aluminium per dose)
​
5.39-6.67 mg
​
Saponine
​
0.30 mg
​
Thiomersal
0.30 mg
​
Excipient q.s
​
3.00 ml
​
For a full list of excipients see section 6.1
​
3 PHARMACEUTICAL FORM
Powder for reconstitution for suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle from 2 months of age.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
To stimulate active immunity against IBR, PI3, BVD and BRS viruses in
cattle.
For active immunisation of cattle to reduce clinical signs of Bovine
Respiratory Syndrome associated with Infectious Bovine
Rhinotracheitis, Parainfluenza-3 virus and Bovine Viral Diarrhoea
virus, as well as to reduce virus shedding and duration of
shedding of BRSV.
Onset and duration of immunity: Immunity conferred by HIPRABOVIS-4
appears at 30-50 days after first vaccination and lasts
for at least 1 year.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
It is advisable to vaccinate all animals in a herd in order to
minimise spread of infection.
Maternal antibodies will reduce the efficacy of the vaccine if
administered to calves less than 2 months of age.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Vaccinate only healthy animals.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Health Products Regulatory Authority
17 June 2019
CRN0094D9
Page 2 of 3