LACTOVAC SUSPENSION FOR INJECTION

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

INACTIVATED BOVINE ROTAVIRUS, STRAIN 1005/78, INACTIVATED BOVINE ROTAVIRUS, STRAIN HOLLAND, INACTIVATED BOVINE CORONAVIRUS, STRAIN 800, INACTIVATED E.COLI K99/F41, STRAIN S1091/83

Pieejams no:

Zoetis Belgium S.A.

ATĶ kods:

QI02AL01

SNN (starptautisko nepatentēto nosaukumu):

INACTIVATED BOVINE ROTAVIRUS, STRAIN 1005/78, INACTIVATED BOVINE ROTAVIRUS, STRAIN HOLLAND, INACTIVATED BOVINE CORONAVIRUS, STRA

Zāļu forma:

Suspension for Injection

Receptes veids:

LM-Licensed Merchant

Ārstniecības grupa:

Bovine

Ārstniecības joma:

Inactivated Bovine rotavirus vaccine + inactivated Bovine coronavirus vaccine + inactivated Escheri

Ārstēšanas norādes:

Immunological - Inactivated vaccine

Autorizācija statuss:

Authorised

Autorizācija datums:

2017-02-10

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Lactovac Suspension for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml dose contains the following:
ACTIVE SUBSTANCES:
Inactivated bovine rotavirus, strain 1005/78 at least 10
7.4
TCID
50
*, inducing > 1 RPU***
Inactivated bovine rotavirus, strain Holland at least 10
7.0
TCID
50
, inducing > 1 RPU
Inactivated bovine coronavirus, strain 800 at least 10
5.8
TCID
50
, inducing > 1 RPU
Inactivated_ E.coli_ K99/F41, strain S1091/83
250-260 HAU**, inducing > 1 RPU
_ADJUVANTS:_
Aluminium hydroxide 60 mg
Saponin / Quil A
1 mg
_EXCIPIENTS:_
Thiomersal
0.05 mg
For the full list of excipients, see section 6.1.
*
Tissue culture infective dose
**
Haemagglutinating units
***
Relative potency unit; 1 RPU = antibody response in rabbit potency
test not significantly lower than that obtained
with a reference batch shown efficacious in cattle.
3 PHARMACEUTICAL FORM
Suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (cows and heifers).
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4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of pregnant
cows and heifers in order to confer passive protection to their calves
(via
colostrum)
to reduce the severity and duration of
neonatal
diarrhoea caused by rotavirus,
coronavir