Advasure - summary of medicine characteristics

Summary of medicine characteristics - Advasure

2. QUALITATIVE AND QUANTITATIVE COMPOSITIONmaximum 1:10,0000.64 ml0.064 ml0.63 mlPer dose of 2 ml:Active substance:E2 glycoprotein of Classical Swine Fever (CSF) virus minimum 32 ^gAdjuvant:

Adjuvant composition – Double oil emulsion:

Mineral oil

Emulsifiers

Phosphate buffered saline

Preservative:

Thiomersal

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Emulsion for injection.

CLINICAL PARTICULAR

4.1

Target species

Pigs.

4.2

Indications for use, specifying the target species

Active immunisation of pigs, over the age of 2 weeks, against Classical Swine Fever (CSF), to prevent mortality, reduce clinical signs of the disease and the excretion of field virus.

The onset of protection is 2 weeks.

The duration of protection is 6 months.

4.3 Contraindications

Special warnings for each target species

The pigs should be vaccinated in time before the expected exposure to the field virus, preferably prior to housing (crowding) or transfer to new groups. It is strongly recommended to vaccinate all pigs in the herd.

4. 5 Special precautions for use

None known.

Special precautions for use in animals

See section 4.4.

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

In case of accidental self-injection, seek medical advice immediately and show the package insert to physician.

To the user:

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

To the physician:

This 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)

Swelling at the injection site may occur, which usually disappears spontaneously within approximately one week after vaccination. These effects are particularly evident in very young animals. Other side effects such as a slight increase in body temperature can occur. In very rare cases diarrhoea, anorexia, depression and vomiting may be observed. Symptomatic treatment should be considered when serious side effects are observed.

As part of the immune reaction following vaccination, mild to moderate granulomas may occur in the muscle tissue at the injection site. In some cases also formation of abscesses was observed. Although not reported so far, very rarely cases of allergic reactions may occur, therefore vaccinated animals should be observed for approximately 30 minutes following vaccination. In those cases, appropriate treatment should be administered.

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy. The vaccine has been shown to prevent transplacental transmission of low virulence strains after two vaccinations of the sow. However it may not prevent transplacental transmission of highly virulent strains from the sow to the foetuses.

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4.8 Interaction with other medicinal products and other forms of interaction

The use of immunosuppressive veterinary medicinal products (e.g. corticosteroids) or modified live Porcine Reproductive and Respiratory Syndrome (PRRS) vaccines within 7 days before and 7 days after application of Advasure may interfere with the induction of immunity and should therefore be avoided.

4.9 Amounts to be administered and administration route

Posology:

The dosage for pigs, over the age of 2 weeks, is 2 ml of the vaccine.

Mode of administration:

In emergency situations the basic immunisation consists of one intramuscular injection with one dose (2 ml) for all pigs over the age of 2 weeks, irrespective of the level of maternal antibodies.

Depending on the infection pressure and the disease situation sows and piglets over the age of 2 weeks (irrespective of the level of maternal antibodies) may be vaccinated twice with one dose (2 ml), 4–6 weeks apart. For fattening pigs over the age of 10 weeks, however, one intramuscular injection with one dose is administered.

Re-vaccination:

One dose (2 ml) at 6 months intervals.

The vaccine is to be administered aseptically by intramuscular injection closely behind the ear.

persist for 2–

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

An overdose of the product can result in a moderate swelling at the injection site 3 weeks.

4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

ATCvet code: QI09AA06

Summary presentation of the active ingredients The Classical Swine Fever (CSF, Hog Cholera

a member of the Pestivirus genus, codes for a

number of structural and non-structural glycoproteins, e.g. E2, E1, Erns, gp54 and gp80. The E2 glycoprotein is considered to be the main immunogen of the CSF virus against which the neutralising antibodies are directed. The gene coding for the E2 glycoprotein (E2 gene) is a rather conserved region. The E2 glycoprotein is considered to be immunologically cross-reactive with all field strains.

The E2 glycoprotein gene was inserted into the genome of a baculovirus, an insect virus. The vaccine contains only the E2 but no other proteins of the CSF virus.

Immunological properties:

The vaccine, as formulated with the mineral oil and the emulsifiers, induces protection in pigs against

clinical signs cau of the vaccine, va than E2.

the Classical Swine Fever (CSF) virus. As a consequence of the subunit nature ion does not induce production of antibodies against CSF virus antigens, other

ACEUTICAL PARTICULARS

t of excipients

Phosphate buffered saline.

6.2 Incompatibilities

Do not mix with any other vaccine or immunological product.

6.3 Shelf life

After first broaching the container, the contents may be used for up to 8 hours if stored at 2°C-8°C.

6.4. Special precautions for storage

Store at 2°C-8°C. Do not freeze. Protect from light.

6.5 Nature and composition of immediate packaging

Multidose containers with appropriate overfill:

– 1 glass vial, type 2, containing 20 ml (10 doses) vaccine, closed with rubber stopper and sealed

with an aluminium seal, packed as 54 vials in 1 styrofoam box

– 1 glass vial, type 1, containing 50 ml (25 doses) vaccine, closed with rubber stopper and sealed

with an aluminium seal, packed as 35 vials in 1 styrofoam box

– 1 glass vial, type 1, containing 100 ml (50 doses) vaccine, closed with rubber stopper and sealed

with an aluminium seal, packed as 12 vials in 1 styrofoam box

– 1 glass vial, type 1, containing 250 ml (125 doses) vaccine, closed with rubber stopper and

sealed with an aluminium seal, packed as 10 vials in 1 styrofoam box

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

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements

7. MARKETING AUTHORISATION HOLDER

Pfizer Ltd.

NUMBER(S)

Sandwich Kent, CT13 9NJ United Kingdom

8. MARKETING AUTHOR

EU/2/00/025/001 – 004