Aftovaxpur DOE - summary of medicine characteristics

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

AFTOVAXPUR DOE emulsion for injection for cattle, sheep and pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose of 2 ml of emulsion contains:

Active substances:

Maximum three of the following purified, inactivated foot-and-mouth disease virus strains:

O1 Manisa.......­.............­.............­.............­.............­.............­.............­.............­.............­.............­.....> 6 PD50*

O1 BFS..........­.............­.............­.............­.............­.............­.............­.............­.............­.............­........> 6 PD50*

O Taiwan 3/97.........­.............­.............­.............­.............­.............­.............­.............­.............­.......... > 6 PD50*

A22 Iraq.........­.............­.............­.............­.............­.............­.............­.............­.............­.............­....... > 6 PD50*

A24 Cruzeiro.....­.............­.............­.............­.............­.............­.............­.............­.............­.............­... > 6 PD50*

A Turkey 14/98........­.............­.............­.............­.............­.............­.............­.............­.............­......... > 6 PD50*

Asia 1 Shamir.....­.............­.............­.............­.............­.............­.............­.............­.............­.............­...> 6 PD50*

SAT2 Saudi Arabia.......­.............­.............­.............­.............­.............­.............­.............­.............­.... > 6 PD50*

• * PD50 – 50% protective dose in cattle as described in Ph. Eur. monograph 0063.

The number and type of strains included in the final product will be adapted to the current epidemiological situation at the time of formulation of the final product and will be shown on the label.

Adjuvant:

Liquid paraffin.....­.............­.............­.............­.............­.............­.............­.............­.............­.............­...537 mg.

Excipients:

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Emulsion for injection.

White emulsion after shaking.

4. CLINICAL PARTICULARS4.1 Target species

Cattle, sheep and pigs.

• 4.2 Indications for use, specifying the target species

Active immunisation of cattle, sheep and pigs from 2 weeks of age against foot-and-mouth disease to reduce clinical signs.

Onset of immunity:

Cattle and sheep: 7 days after vaccination.

Pigs: 4 weeks after vaccination.

Duration of immunity: vaccination of cattle, sheep and pigs induced the production of neutralising antibodies that persisted for at least 6 months. In cattle, the antibody levels measured were above those shown to be protective.

4.3 Contraindications

None.

• 4.4 Special warnings for each target species

Vaccinate healthy animals only.

Maternal antibodies may interfere with vaccination. Schedule should be adjusted accordingly (see section 4.9).

When very young pigs (at 2 weeks old) have to be vaccinated, revaccination at 8–10 weeks is recommended

• 4.5 Special precautions for use

Special precautions for use in animals

None.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

To the user:

This veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.

If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.

If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the physician:

This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

• 4.6 Adverse reactions (frequency and seriousness)

Swellings (diameter of up to 12 cm in ruminants and 4 cm in pigs) occurred very commonly in most animals after administration of a dose of vaccine. These local reactions normally resolve over a period of four weeks post vaccination, but may persist for longer in a small number of animals.

A slight increase of rectal temperature of up to 1.2 °C for 4 days post-vaccination with no other generalised clinical signs is commonly observed.

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).

• 4.7 Use during pregnancy, lactation or lay

Pregnancy:

Can be used during pregnancy.

Lactation:

The safety of the veterinary medicinal product has not been established during lactation. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.

4.8 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.

• 4.9 Amounts to be administered and administration route

Homogenize the content of the vial by gentle mixing before the insertion of needle. This is best achieved by inverting the vial several times base over apex. Do not mix the vaccine by vigorous shaking because it leads to entrapment of air bubbles.

Do not warm the product before use.

Apply usual aseptic procedures. Avoid accidental contamination of the vaccine after first broaching and during use.

Primary vaccination :

Cattle from 2 weeks of age:

Sheep from 2 weeks of age:

Pigs from 2 weeks of age:

The use of a multiple injection device is recommended.

Revaccination : every six months.

When animals have to be vaccinated in presence of maternal antibodies, revaccination at 8–10 weeks is recommended.

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

No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double dose to calves, lambs and piglets.

In some cases ulceration may occur at the injection site. Following repeated administration at short intervals, the intensity of these reactions may be increased.

• 4.11 Withdrawal period(s)

Zero days.

• 5. IMMUNOLOGICAL PROPERTIES

Pharmaceutical group: inactivated viral vaccine, foot-and-mouth disease virus.

ATCvet code: QI02AA04.

To stimulate active immunity of cattle, sheep and pigs against purified, inactivated foot-and-mouth disease virus strain antigens related to those contained in the vaccine.

In trials the following has been demonstrated:

Vaccination of cattle with strains O1 Manisa, O1 BFS, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia1 Shamir and SAT2 Saudi Arabia resulted in a reduction of clinical signs in animals exposed to infection.

Vaccination of sheep with strain O1 Manisa resulted in a reduction of clinical signs in animals exposed to infection.

Vaccination of pigs with strain Asia1 Shamir resulted in a reduction of clinical signs and virus shedding in animals exposed to infection. Vaccination of pigs with strains O Taiwan 3/97 and A22 Iraq resulted in a reduction of clinical signs in animals exposed to infection.

Inactivated foot-and-mouth disease antigens are purified and do not contain sufficient amounts of non-structural proteins (NSP) to induce an antibody response following administration of a trivalent vaccine containing an amount of antigen corresponding with at least 15 PD50 per strain per dose of 2 ml.

No antibodies to NSP were detected using the PrioCHECK FMDV NS test kit:

• – in cattle following administration of a double dose followed by a single dose 7 weeks later and a third vaccination with a single dose 13 weeks after the second dose,

• – in sheep following administration of a double dose followed by a single dose 5 weeks later and a third vaccination with a single dose 7 weeks after the second dose,

• – in pigs following administration of a double dose followed by a single dose 3 weeks later and a third vaccination with a single dose 7 weeks after the second dose.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Paraffin, liquid

Mannide mono-oleate

Polysorbate 80

Trometamol

Sodium chloride

Potassium dihydrogen phosphate

Potassium chloride

Disodium phosphate anhydrous

Potassium hydroxide

Water for injections.

6.2 Major incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf life

Shelf life of the veterinary medicinal product not containing strain Asia1 Shamir as packaged for sale: 6 months.

Shelf life of the veterinary medicinal product containing strain Asia1 Shamir as packaged for sale: 2 months.

Shelf life after first opening the immediate packaging: use immediately.

6.4 Special precautions for storage

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

Do not freeze.

Protect from light.

• 6.5 Nature and composition of immediate packaging

Polypropylene bottle with a nitrile elastomer closure and sealed with an aluminium cap.

Pack sizes:

• – Cardboard box with 1 bottle of 10, 25, 50, 100 or 150 doses;

• – Cardboard box with 10 bottles of 10, 25, 50, 100 or 150 doses.

Not all pack sizes may be marketed.

• 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelhe­im/Rhein

GERMANY

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/13/153/001– 850

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 15/07/2013

Date of last renewal: 14/06/2018