Trivacton 6

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Bovine coronavirus, Bovine rotavirus, Escherichia coli

Available from:

Boehringer Ingelheim Animal Health UK Ltd

ATC code:

QI02AL01

INN (International Name):

Bovine coronavirus, Bovine rotavirus, Escherichia coli

Pharmaceutical form:

Suspension for injection

Prescription type:

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

Therapeutic group:

Cattle

Therapeutic area:

Inactivated Viral and Bacterial Vaccine

Authorization status:

Expired

Authorization date:

2001-05-31

Summary of Product characteristics

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