Covexin® 10

Composition

Each 1 ml dose of vaccine contains

Active substances                                                   Potency value/mL

C. 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 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#

Adjuvant

Aluminium potassium sulphate (alum)            3,026 – 4,094 ppm

Excipients

Thiomersal                                                 0.12-0.18mg

Formaldehyde≤ 0.05% w/v

PHARMACEUTICAL FORM

1. Suspension for injection.

2. Light brown aqueous suspension that settles on storage.

Target species

Sheep and cattle from 2 weeks of age

Indications for use

1. For the active immunisation of sheep and cattle against disease associated with infections caused by lostridium perfringens type A, C. perfringens type B, C. perfringens type C, C. perfringens type D, C. chauvoei, C. novyi type B, C. septicum, C. ordellii and C. haemolyticum and against tetanus caused by C.tetani.

2. For the passive immunisation of lambs and calves against infections caused by the above mentioned clostridial species (except C. haemolyticum in sheep)

3. 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.

Contraindications

None

Special precautions

i) Special precautions for use in animals

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

2. Do not vaccinate sick or immunodeficient animal

iii)Other precautions

None

Adverse reactions (Frequency & seriousness)

1. 75 – 100% of animals vaccinated with Covexin 10 may experience reactions to vaccination.

2. Most commonly reported adverse 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.

3. 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 25cm diameter may be seen in cattle.

4. 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.

5. An abscess may develop in some animals.

6. Vaccination may give rise to reactions in the underlying tissues at the injection site.

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

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

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

Use during pregnancy and lactation

No side effects other than those described previously 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, the use of the vaccine is not recommended during the first or second third of pregnancy.

Avoid stress in pregnant ewes and cows.

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.

Dosage

Sheep

from 2 weeks of age – 1 ml

Cattle

from 2 weeks of age – 2 ml

Route of administration

1. By subcutaneous injection at a suitable site.

2.The recommended site is the loose skin on the side of the neck.

Precautions :

1. The bottle should be well shaken before any vaccine is withdrawn.

2. 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.

Vaccination Program

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.

Overdose

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

Withdrawal period

Zero days

Incompatibilities

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

Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale: 30 months.

Shelf-life after first opening the immediate packaging: 8 hours.

Special precautions for storage

Store and transport refrigerated (2 °C – 8 °C).

Protect from light.

Do not freeze.