TRIVACTON 6

Ireland - English - 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:
Merial Animal Health Limited
ATC code:
QI02AL01
INN (International Name):
Inactivated bovine coronavirus strain f15, Inactivated bovine rotavirus strain ro1, Inactivated e.coli k99 strain serotype o101,
Dosage:
1.9/3.0/0.6/0.9/0.7/1.6 Seroagglutinating antibody titre
Pharmaceutical form:
Suspension for injection
Prescription type:
LM: Licensed Merchant as defined in relevant national legislation
Therapeutic group:
Cattle
Therapeutic area:
bovine rotavirus + bovine coronavirus + escherichia
Therapeutic indications:
Immunological - Inactivated Vaccine
Authorization status:
Authorised
Authorization number:
VPA10857/032/001
Authorization date:
2003-08-06

Read the complete document

IRISH MEDICINES BOARD ACT 1995

EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (No. 2) REGULATIONS 2007

(S.I. No. 786 of 2007)

VPA:

10857/032/001

Case No: 7004880

The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby

grants to:

Merial Animal Health Limited

Sandringham House

Sandringham Avenue, Harlow Business Park, Harlow

Essex CM19 5TG

United Kingdom

an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the

Veterinary Medicinal Product:

Trivacton 6

The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may

be specified in the said Schedule.

The authorisation,unless revoked, shall continue in force from

30/01/2009

Signed on behalf of the Irish Medicines Board

________________

A person authorised in that behalf by the said Board.

(NOTE: This authorisation replaces any previous authorisation in respect of this product which is now null and void.)

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1

Part II

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

TRIVACTON 6.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

* 1SA.U = q.s. to obtain to obtain a seroagglutinating antibody titre of 1 log

in mice after one administration of

vaccine.

** 1SN.U = q.s. to obtain a seroneutralising antibody titre of 1 log

in guinea-pigs after two administrations of

vaccine.

For a full list of excipients, see section 6.1

Each 5 ml of vaccine contains:

Active substance(s):

Inactivated E. coli (antigen K99)

SA.U*

Inactivated E. coli (antigen Y)

SA.U*

Inactivated E. coli (antigen 31A)

SA.U*

Inactivated E. coli (antigen F41)

SA.U*

Inactivated bovine rotavirus

SN.U**

Inactivated bovine coronavirus

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

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2

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.

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 immediately, and show the package leaflet or label to the

physician.

4.6 Adverse reactions (frequency and seriousness)

Local reactions at the site of injection (

10 cm) may appear after vaccination. These usually disappear within 14 days.

A slight increase in mean rectal temperature (

0.5°C) may be observed for one or two days following the injection.

In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic

treatment.

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy.

4.8 Interaction with other medicinal products and other forms of interaction

No information is available on the compatibility of this vaccine with any other.

Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at

different times) has not been demonstrated.

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3

4.9 Amounts to be administered and administration route

Shake well before use.

Apply usual aseptic procedures.

Inject one 5 ml dose by subcutaneous injection according to the following schedule:

Pregnant cows or heifers

Dose: 5-ml

Administration: subcutaneous injection

Basic vaccination scheme:

First dose: 2 – 6 weeks before calving.

Second dose: at least two weeks after the first dose, a minimum of 14 days before calving (dairy cows) and up to the

day of calving (suckler cows).

Re-vaccination scheme:

One dose two weeks before each calving (dairy cows), or during the two week period before calving (suckler cows).

The protection of calves is obtained by ingestion of colostrum: Make sure that each animal rapidly ingests a sufficient

quantity of colostrum. Calves must be fed colostrum as follows:

Day 1: early pure colostrum from vaccinated cow sufficient to provide 10 % of the calf weight during the first 24 hours.

During the next three weeks:

Calves born to suckler cows: Allow calves to suckle naturally.

Calves born to dairy cows: Store colostrum by deep freezing. Add colostrum (10 % by volume of the total feed) to the

milk substitute.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

After administration of a double dose of vaccine, a local reaction at the site of injection may appear as a slight oedema

evolving to a firm swelling, usually disappearing within 14 days of vaccination.

A slight transient temperature rise (mean 0.7°C) may be observed for two days following the injection.

4.11 Withdrawal Period(s)

Zero days.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

ATCvet code: QI02AL01

Inactivated adjuvanted vaccine for cows, which stimulates the production of antibodies to rotavirus, coronavirus and E.

coli which may be passed to the calf

through colostrum intake.

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4

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Thiomersal

Salts

Water

6.2 Incompatibilities

Do not mix with any other medicinal product.

6.3 Shelf-life

Shelf-life as packaged for sale: 18 months.

Shelf- life after first opening: Use immediately after opening

6.4 Special precautions for storage

Store refrigerated 2°C - 8°C.

Protect from light.

6.5 Nature and composition of immediate packaging

Nature of basic packaging elements:

Type I glass

Butyl elastomer closure

Aluminium cap

Packaging:

1-dose (5 ml) bottle, box of 1 bottle.

10-dose (50 ml) bottle, box of 1 bottle.

20-dose (100 ml) bottle, box of 1 bottle.

1-dose (5 ml) bottle, box of 100 bottles.

1-dose (5 ml) bottle, box of 50 bottles.

1-dose (5 ml) bottle, box of 10 bottles.

Not all presentations may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be

disposed of in accordance with the local requirements.

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5

7 MARKETING AUTHORISATION HOLDER

Merial Animal Health Limited

PO Box 327

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10857/032/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

August 2008

10 DATE OF REVISION OF THE TEXT

January 2009

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6

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