Trivacton 6

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Bovine coronavirus, Bovine rotavirus, Escherichia coli

Verfügbar ab:

Boehringer Ingelheim Animal Health UK Ltd

ATC-Code:

QI02AL01

INN (Internationale Bezeichnung):

Bovine coronavirus, Bovine rotavirus, Escherichia coli

Darreichungsform:

Suspension for injection

Verschreibungstyp:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Therapiegruppe:

Cattle

Therapiebereich:

Inactivated Viral and Bacterial Vaccine

Berechtigungsstatus:

Expired

Berechtigungsdatum:

2001-05-31

Fachinformation

Revised: November 2018
AN: 01110/2018
Page 1 of 4
SUMMARY OF PRODUT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
TRIVACTON 6
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 5-ml of vaccine contains:
- _E. coli_ K99 antigen, at least
………………………………..……..1.15 SA.U
- _E. coli_ Y antigen, at least
…………………………………..……...0.9 SA.U
- _E. coli_ 31A antigen, at
least……………………………………….1.6 SA.U
- _E. coli_ F41 antigen, at least
………………………………………0.7 SA.U
- Inactivated bovine rotavirus, at least
…………………………….3.0 SN.U
- Inactivated bovine coronavirus, at least
…………………………1.9 SN.U
- Aluminium hydroxide (expressed in Al
+++
) ………………………3.5 mg
- Saponin
…………………………………………………………….1.5
mg
- Thiomersal*
………………………………………………………...0.5
mg
- Excipient q.s.
………………………………………………..……..5 ml
1 SA.U: q.s. to obtain an agglutinating antibody titre of 1 log
10
in mice after
an administration of vaccine.
1 SN.U: q.s. to obtain a neutralising antibody titre of 1 log
10
in guinea-pigs
after two administrations of vaccine.
* Multidose containers only
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (pregnant females)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For administration to pregnant cows and heifers to stimulate
serological and
colostral antibodies against rotavirus and coronavirus antigens and
against
K99, Y, 31A and F41 antigens of _ Escherischia coli_ in susceptible
animals,
which may be passed to the calf to reduce neonatal diarrhoea infection
caused by agents containing these antigens.
4.3
CONTRA-INDICATIONS
None.
Revised: November 2018
AN: 01110/2018
Page 2 of 4
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL P