TRIVACTON 6

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Inactivated bovine coronavirus strain f15; Inactivated bovine rotavirus strain ro1; Inactivated e.coli k99 strain serotype o101; Inactivated e.coli y strain serotype o117; Inactivated e.coli f41 strain serotype o101; Inactivated e. coli 31a strain serotype O78

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QI02AL01

INN (International Name):

Inactivated bovine coronavirus strain f15; Inactivated bovine rotavirus strain ro1; Inactivated e.coli k99 strain serotype o101; Inactivated e.coli y strain serotype o117; Inactivated e.coli f41 strain serotype o101; Inactivated e. coli 31a strain serotype O78

Dosage:

.

Pharmaceutical form:

Suspension for injection

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic area:

bovine rotavirus + bovine coronavirus + escherichia

Authorization status:

Authorised

Authorization date:

2003-08-06

Summary of Product characteristics

Health Products Regulatory Authority
29 May 2020
CRN009PHD
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
TRIVACTON 6
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of vaccine contains:
Active substance(s):
Inactivated E. coli (antigen K99)
≥ 0.6
SA.U*
Inactivated E. coli (antigen Y)
≥ 0.9
SA.U*
Inactivated E. coli (antigen 31A)
≥ 1.6
SA.U*
Inactivated E. coli (antigen F41)
≥ 0.7
SA.U*
Inactivated bovine rotavirus
≥ 3.0
SN.U**
Inactivated bovine coronavirus
≥ 1.9
SN.U**
Adjuvants:
Aluminium hydroxide
3.5
mg
(expressed in Al
+++
)
Saponin
1.5
mg
Excipients:
Thiomersal
0.5
mg
Residual formaldehyde
2.5
mg
Excipient q.s.
5.0
ml
* 1SA.U = q.s. to obtain to obtain a seroagglutinating antibody titre
of 1 log
10
in mice after one administration of vaccine.
** 1SN.U = q.s. to obtain a seroneutralising antibody titre of 1 log
10
in guinea-pigs after two administrations of vaccine.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (pregnant cows and heifers).
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
_Escherichia coli_ in susceptible animals, which may be passed
to the calf via the colostrum to reduce neonatal diarrhoea infection
caused by agents containing these antigens.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Optimal results require a whole herd vaccination policy in conjunction
with good hygiene practices.
Health Products Regulatory Authority
29 May 2020
CRN009PHD
Page 2 of 4
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
In the case of accidental self-injection seek medical advice
im