Introduction

Company name: Intervet / Schering-Plough Animal Health

Address: Walton Manor

Walton

Milton Keynes

MK7 7AJ

Telephone: 01908 685685 (Customer Support Centre)

Telephone: 0370 060 3380 (Switchboard)

Fax: 01908 685555

Email: support.uk@intervet.com

Website: www.intervet.co.uk

Presentation

Bravoxin 10 is a liquid vaccine for injection containing inactivated clostridial antigens with an aluminium potassium sulphate (alum) adjuvant. It is a light brown aqueous suspension that settles on storage, which resuspends on shaking.

Each 1 ml dose of vaccine contains at least:

Active substance	Potency per ml
Clostridium perfringens type A (α) toxoid	≥ 0.5 U#
C. perfringens type B & C (β) toxoid	≥ 18.2 IU*
C. perfringens type D (ε) toxoid	≥ 5.3 IU*
C. chauvoei whole culture	≥ 90% protection**
C. novyi type B toxoid	≥ 3.8 IU*
C. septicum toxoid	≥ 4.6 IU*
C. tetani toxoid	≥ 4.9 IU*
C. sordellii toxoid	≥ 4.4 U1
C. haemolyticum toxoid	≥ 17.4 U#

* ELISA According to PhEur

1 In House ELISA

** Guinea pig challenge test according to PhEur

# In vitro toxin neutralisation test based on haemolysis of sheep erythrocytes.

Adjuvant
Aluminium potassium sulphate (alum)	3,026 - 4,094 ppm
Excipient
Thiomersal	0.12 - 0.18 mg
Formaldehyde	≤ 0.05% w/v

Uses

For the active immunisation of sheep and cattle against diseases caused by Clostridium perfringens type A; C. perfringens type B; C. perfringens type C; C. perfringens type D; C. chauvoei; C. novyi type B; C. septicum; C. sordellii; C. haemolyticum and against tetanus caused by C. tetani. For the passive immunisation of lambs and calves against infection caused by the above mentioned clostridial species (except C. haemolyticum in sheep).

The onset of immunity is two weeks after the primary course.

Duration of active immunity:

An anamnestic humoral immune response (immunological memory) to all components was demonstrated 12 months following the primary course of vaccination.

As demonstrated by serology/persistent antibody titre only:
Sheep:	12 months against C. perfringens types A, B, C and D; C. novyi type B; C. sordellii and C. tetani.
	< 6 months against C. septicum; C. haemolyticum and C. chauvoei.
Cattle:	12 months against C. tetani and C. perfringens type D.
	< 12 months against C. perfringens types A, B and C.
	< 6 months against C. novyi type B; C. septicum; C. sordellii; C. haemolyticum and C. chauvoei.

Duration of passive immunity as demonstrated by serology/persistent antibody titre only is:
For lambs:	At least 2 weeks for C. septicum and C. chauvoei,
	at least 8 weeks for C. perfringens type B and C. perfringens type C, and
	at least 12 weeks for C. perfringens type A; C. perfringens type D; C. novyi type B; C. tetani and C. sordellii.
	No passive immunity was observed for C. haemolyticum.
For calves:	At least 2 weeks for C. sordellii and C. haemolyticum,
	at least 8 weeks for C. septicum and C. chauvoei and
	at least 12 weeks for C. perfringens type A; C. perfringens type B; C. perfringens type C; C. perfringens type D; C. novyi type B and C. tetani.

Dosage and administration

Sheep

From 2 weeks of age: Dose - 1 ml

Cattle

From 2 weeks of age: Dose - 2 ml

By subcutaneous injection at a suitable site. The recommended site is the loose skin on the side of the neck.

Shake the bottle well before use.

Syringes and needles should be sterile before use and the injection should be made through an area of clean, dry skin taking precautions against contamination.

Primary vaccination

Two doses should be administered, 4-6 weeks apart.

Booster vaccination

A single dose should be administered at 6 to 12 month intervals.

Use in pregnancy

To provide passive protection of the offspring, via the colostrum, a single booster dose should be administered between 8 and 2 weeks before parturition, provided that animals have received a full primary vaccination course before pregnancy.

Contra-indications, warnings, etc

75 - 100% of animals vaccinated with Bravoxin 10 may experience reactions to vaccination.

Most commonly reported reactions are localised swelling or induration at the injection site but may also include mild hyperthermia, abscess or other reaction in the underlying tissues at the injection site.

Swelling at the injection site occurs in the majority of animals. This may reach up to a mean value of 6 cm in sheep and 15 cm diameter in cattle; occasionally reactions of up to 25 cm diameter may be seen in cattle. Most local reactions resolve within 3-6 weeks in sheep and in less than 10 weeks in cattle, but may persist longer in a minority of animals.

An abscess may develop in some animals. Vaccination may give rise to reactions in the underlying tissues at the injection site.

Skin discolouration at the injection site (which returns to normal as the local reaction resolves) may occur.

Localised pain at the injection site for 1-2 days post first vaccination may occur.

The local reactions do not affect the general health, demeanour, feeding or weight gain of the animals.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

In calves and lambs, local reactions may increase slightly if twice the recommended dose is administered.

Special warnings

In the event of an anaphylactic reaction appropriate treatment such as adrenaline should be administered without delay.

Do not vaccinate sick or immunodeficient animals.

No side effects other than those already described were seen when the vaccine was used in sheep and cattle between 8 and 2 weeks prior to parturition. In the absence of specific data, no recommendation can be made for use of the vaccine during the first or second third of pregnancy.

Avoid stress in pregnant ewes and cows.

The effectiveness of the vaccine in providing passive immunity to young lambs and calves depends on these animals ingesting adequate amounts of colostrum on the first day of life.

Clinical trials have demonstrated that the presence of maternal antibodies (MDA), particularly against C. tetani, C. novyi type B, C. perfringens type A (calves only), C. chauvoei (lambs only) and C. perfringens type D may reduce the antibody response to vaccination in young lambs and calves. Therefore, to ensure an optimal response in young animals with high levels of MDA, the primary vaccination should be delayed until the levels wane (which is after about 8-12 weeks of age).

Do not mix with any other vaccine, immunological or veterinary medicinal products.

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.

Operator warnings

In the case of accidental self-injection, encourage bleeding and wash the area immediately with water. If a local reaction develops, seek medical advice showing the package insert or the label to the physician.

Withdrawal period: Zero days.

For animal treatment only. Keep out of the reach and sight of children.

Pharmaceutical precautions

Store and transport between +2°C and +8°C. Protect from light. Do not freeze.

Do not use after the expiry date, which is stated on the bottle label and the carton after ‘EXP’.

Shelf-life after first opening the container

Part used containers of the vaccine should be discarded within 8 hours of first opening. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

POM-VPS

Packaging Quantities

Packs containing 1 bottle of 20 ml, 50 ml and 100 ml.

Not all pack sizes may be marketed.

Further information

Nil

Marketing authorisation number

Vm 00201/4235.

Significant Changes