HIPRABOVIS-BALANCE
Maa: Espanja
Kieli: englanti
Lähde: HMA (Heads of Medicines Agencies)
Pakkausseloste
(PIL)
24-10-2012
Valmisteyhteenveto
(SPC)
24-10-2012
Aktiivinen ainesosa:
bovine respiratory syncytial virus 10000 TCID50, bovine viral diarrhoea virus inactivated 20 SN, parainfluenza 3 Virus inactivated 16 HAI
Saatavilla:
Laboratorios Hipra S. A.
ATC-koodi:
QI02AH
Lääkemuoto:
Powder and solvent for suspension for injection
Terapeuttinen ryhmä:
Live and Inactivated viral vaccines
Terapeuttinen alue:
Cattle Food
Valtuutus päivämäärä:
2010-09-16
Pakkausseloste
_[Version 7.3, 04/2010] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HIPRABOVIS BALANCE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition per dose (3 ml):
Active substances:
Parainfluenza-3 virus, inactivated, strain SF4
………...……..…………… HAI* ≥ 16
(≥ 480 HAU before inactivation)
Bovine viral diarrhoea virus, inactivated, strain NADL …………..…….... SN**
≥ 20
(≥ 10
6
TCID
50
before inactivation)
Bovine respiratory syncytial virus, live, strain Lym-56
………..…... ≥ 10
4
TCID
50
***
* HAI: mean haemagglutination inhibition titre induced
in rabbits.
* SN: mean serum neutralisation titre induced in rabbits.
*** TCID
50
: Tissue culture infective dose 50
Adjuvants:
Aluminium hydroxide (Al
3+
) ................................................................................. 6.34
mg
Excipients
Thimerosal (preservative) ....................................................................................... 0.3
mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
The lyophilisate is a yellowish tablet.
The solvent is a pinkish liquid.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Bovine (cows, heifers and calves; as of 4 weeks old)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Adult cattle (cows and heifers): prevention of bovine viral diarrhoea (including the disease
of the mucosas) (BVD).
Calves: prevention of the Parainfluenza 3 (PI3) virus, disease of the mucosas or bovine
viral diarrhoea (BVD) and
pneumonia by bovine respiratory syncytial virus (BRS).
Immunity starts thre
Lue koko asiakirja
Valmisteyhteenveto
_[Version 7.3, 04/2010] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HIPRABOVIS BALANCE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition per dose (3 ml):
Active substances:
Parainfluenza-3 virus, inactivated, strain SF4
………...……..…………… HAI* ≥ 16
(≥ 480 HAU before inactivation)
Bovine viral diarrhoea virus, inactivated, strain NADL …………..…….... SN**
≥ 20
(≥ 10
6
TCID
50
before inactivation)
Bovine respiratory syncytial virus, live, strain Lym-56
………..…... ≥ 10
4
TCID
50
***
* HAI: mean haemagglutination inhibition titre induced
in rabbits.
* SN: mean serum neutralisation titre induced in rabbits.
*** TCID
50
: Tissue culture infective dose 50
Adjuvants:
Aluminium hydroxide (Al
3+
) ................................................................................. 6.34
mg
Excipients
Thimerosal (preservative) ....................................................................................... 0.3
mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
The lyophilisate is a yellowish tablet.
The solvent is a pinkish liquid.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Bovine (cows, heifers and calves; as of 4 weeks old)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Adult cattle (cows and heifers): prevention of bovine viral diarrhoea (including the disease
of the mucosas) (BVD).
Calves: prevention of the Parainfluenza 3 (PI3) virus, disease of the mucosas or bovine
viral diarrhoea (BVD) and
pneumonia by bovine respiratory syncytial virus (BRS).
Immunity starts thre
Lue koko asiakirja
