Respiporc Flu3 - summary of medicine characteristics

SUMMARY OF PRODUCT CHARACTERISTICS

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Respiporc FLU3 suspension for injection for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose of 2 ml contains:

Active substances:

Strains of inactivated Influenza A virus/swine/

Bakum/IDT1769/2003 (H3N2)

Haselünne/IDT2617/2003 (H1N1)

Bakum/1832/2000 (H1N2) 1GMNU = Geometric mean of neutralizing units induced in Guinea pigs after twice immunisation with 0.5 ml of this vaccine

Adjuvant:

Carbomer 971 P NF          2.0 mg

Excipient:

Thiomersal                  0­.21 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Clear, yellowish orange to pink coloured suspension for injection.

4. CLINICAL PARTICULARS4.1. Target species

Pigs

• 4.2. Indication for use, specifying the target species

Active immunisation of pigs from the age of 56 days onwards including pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection.

7 days after primary vaccination

4 months in pigs vaccinated between the age of 56 and 96 days and

6 months in pigs vaccinated for the first time at 96 days and above.

Active immunisation of pregnant sows after finished primary immunisation by administration of a single dose 14 days prior to farrowing to develop high colostral immunity which provides clinical protection of piglets for at least 33 days after birth.

4.3. Contraindications

None.

• 4.4. Special warnings for each target species

None.

• 4.5. Special precautions for use

Special precautions for use in animals

Not applicable.

Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection only a minor injection site reaction is expected.

• 4.6. Adverse reactions (frequency and seriousness)

A transient slight swelling may occur on very rare occasions after vaccination at the site of injection, regressing within 2 days. On very rare occasions, a slight transient rectal temperature increase might occur after vaccination.

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

Can be used during pregnancy and lactation.

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

For intramuscular use.

Piglets:

Primary vaccination: 2 injections of one dose (2 ml)

• – From the age of 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 6 months.

or

• – Between the age of 56 and 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 4 months.

Gilts and sows:

Primary vaccination: see above

A booster is possible at each stage of pregnancy and lactation. When vaccination is performed 14 days prior to farrowing with one dose (2 ml), it provides maternally-derived immunity to the piglets which protects them from clinical signs of influenza at least until day 33 after birth.

Maternally-derived immunity in the piglets interacts with antibody induction. Generally, maternally-derived antibodies induced by vaccination last for approx. 5–8 weeks after birth. In particular cases of multiple contacts of the sows with antigens (field infections + vaccination) the antibodies transmitted to the piglets may last until week 12 of life. In the latter case piglets should be vaccinated after the age of 96 days.

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

After administration of a double dose (4 ml), no adverse reactions other than those described in section 4.6 were observed.

• 4.11. Withdrawal period(s)

Zero days

• 5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunologicals,

ATCvet code: QI09AA03

The vaccine stimulates an active immunity against Swine Influenza A virus subtypes H1N1, H3N2 and H1N2. It induces neutralizing and haemagglutination inhibiting antibodies against each of the three subtypes. When a single dose of the vaccine is administered 14 days prior to farrowing as a booster to previously vaccinated sows, the vaccine stimulates active immunity in order to provide maternally-derived immunity to the progeny against Swine Influenza A virus subtypes H1N1, H3N2 and H1N2.

6. PHARMACEUTICAL PARTICULARS6.1. List of excipients

Carbomer 971 P NF

Thiomersal

Sodium chloride solution (0.9%)

6.2. Major incompatibilities

Do not mix with any other veterinary medicinal product.

• 6.3. Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the vial: 10 hours.

6.4. Special precautions for storage

Store in a refrigerator (2 °C – 8 °C). Do not freeze.

Keep the vial in the outer carton in order to protect from light.

• 6.5. Nature and composition of immediate packaging

Glass vial:              20 ml vials, glass type I

50 ml vials, glass type II

100 ml vials, glass type II

PET vials:             20 ml Polyethylene terephthalate (PET) vials, clear

50 ml PET vials, clear

100 ml PET vials, clear

500 ml PET vials, clear

Stoppers:              B­romobutyl rubber stoppers

Caps:                 ­Flanged caps

Package sizes:

Cardboard box with 1 glass vial of 10 doses (20 ml), 25 doses (50 ml) or 50 doses (100 ml) with a rubber stopper and flanged cap.

Cardboard box with 1 PET vial of 10 doses (20 ml), 25 doses (50 ml) or 50 doses (100 ml) with a rubber stopper and flanged cap.

Cardboard box with 8 PET vials of 250 doses (500 ml) with a rubber stopper and flanged cap.

Not all pack sizes may be marketed.

• 6.6. Special precautions for the disposal of unused veterinary medicinal products 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 the local requirements.

7. MARKETING AUTHORISATION HOLDER

Ceva Santé Animale

• 10 av. de La Ballastière

8. MARKETING AUTHORISATION NUMBER

EU/2/09/103/001–007

9. DATE OF FIRST AUTHORISATION

Date of first authorisation: 14/01/2010

Date of last renewal: 04/12/2014