Coxevac - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

COXEVAC suspension for injection for cattle and goats

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder :

CEVA Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

Manufacturer responsible for batch release :

CEVA-Phylaxia Veterinary Biologicals Co. Ltd.

Szâllâs u. 5

1107 Budapest

HUNGARY

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

COXEVAC suspension for injection for cattle and goats

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each ml contains:

Active substance:

Inactivated Coxiella burnetii, strain Nine Mile > 72 QF Units*

• *QF (Q fever) Unit: relative potency of phase I antigen measured by ELISA in comparison with a reference item.

Excipients:

Thiomersal

Whitish, opalescent, homogeneous suspension.

Cattle:

For the active immunisation of cattle to lower the risk for non-infected animals vaccinated when nonpregnant to become shedder (5 times lower probability in comparison with animals receiving a placebo), and to reduce shedding of Coxiella burnetii in these animals via milk and vaginal mucus. Onset of immunity: not established.

Duration of immunity: 280 days after completion of the primary vaccination course.

Goats:

For the active immunisation of goats to reduce abortion caused by Coxiella burnetii and to reduce shedding of the organism via milk, vaginal mucus, faeces and placenta.

Onset of immunity: not established.

Duration of immunity: one year after completion of the primary vaccination course.

• 5. CONTRAINDI­CATIONS

None.

• 6. ADVERSE REACTIONS

Cattle:

It was very common to see in laboratory trials a palpable reaction of maximum diameter of 9 to 10 cm at the injection site, which may last for 17 days. The reaction gradually reduces and disappears without need for treatment.

Systemic signs as lethargy, hyperthermia and/or anorexia have been observed rarely in post marketing safety experience.

Goats:

It was very common to see in laboratory trials a palpable reaction of 3 to 4 cm diameter at the injection site which may last for 6 days. The reaction reduces and disappears without need for treatment.

It was very common to observe in laboratory trials a slight increase of rectal temperature for 4 days post-vaccination.

Systemic signs as lethargy, malaise and/or anorexia have been observed uncommonly in post marketing safety experience.

Diarrhoea has been observed rarely in post marketing safety experience.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Cattle and goats

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Subcutaneous use.

Administer the vaccine as follows:

Cattle: 4 ml in the neck region.

Goats: 2 ml in the neck region.

Cattle from 3 months of age:

Primary vaccination:

Two doses should be given subcutaneously with an interval of 3 weeks. Under normal conditions the timing of vaccination should be planned so that the primary course is completed by 3 weeks before artificial insemination or mating.

Re-vaccination:

Every 9 months, as described for primary vaccination, based on a duration of immunity of 280 days.

Goats from 3 months of age:

Primary vaccination:

Two doses should be given subcutaneously with an interval of 3 weeks. Under normal conditions the timing of vaccination should be planned so that the primary course is completed by 3 weeks before artificial insemination or mating.

Re-vaccination:

One dose should be given yearly.

• 9. ADVICE ON CORRECT ADMINISTRATION

Shake well before use.

Respect normal aseptic conditions.

• 10. WITHDRAWAL PERIOD(S)

Meat, milk and offal: Zero days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

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

Do not freeze.

Protect from light.

Do not use this veterinary medicinal product after the expiry date which is stated on the label after {EXP}.

Shelf life after first opening the container: 10 hours.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

Vaccination of animals already infected at the time of vaccination will have no adverse effect.

No efficacy data are available concerning the use of the vaccine in male animals. However, in safety laboratory trials, the use of the vaccine in males proved to be safe. In the case that it is decided to vaccinate the whole herd, it is advisable to vaccinate the male animals at the same time.

The biological significance of the levels of reduction shown in shedding in cattle and goats is not known.

Special precautions for use in animals :

It is advisable to vaccinate all the animals in the herd at the same time.

Under field conditions, vaccination with COXEVAC has commonly been followed by a decrease in milk production in goats. Since stress could contribute to this adverse reaction, appropriate precautions should be taken to reduce stress as much as possible during the administration of the product.

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 the label, to the physician.

Pregnancy :

There are no benefits of the vaccine (as described in the indications for cattle), when used in infected and/or pregnant cows.

Lactation :

The vaccine can be used during lactation.

Under field conditions, vaccination with COXEVAC has been followed by a decrease in milk production, commonly in goats and rarely in cattle. Since stress could contribute to this adverse reaction, appropriate precautions should be taken to reduce stress as much as possible during the administration of the product.

Interaction with other medicinal products and other forms of interaction:

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

Overdose (symptoms, emergency procedures, antidotes) :

Cattle:

With double dose, a palpable reaction of maximum diameter of 10 cm was observed at the injection site, lasting for 16 days. The reaction gradually reduced and disappeared without need for treatment. Goats:

With double dose, a moderate palpable reaction of diameter of 4 to 5 cm was observed at the injection site, lasting for 4 days. The reaction reduced and disappeared without need for treatment.

Incompatibilities :

Do not mix with any other veterinary medicinal product.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency

• 15. OTHER INFORMATION