BIOSUIS Entero

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Farmaceutical form

Suspension for injection

The vaccine contains inactivated porcine rotavirus, serogroup A, selected serovars of inactivated enterotoxigenic E. coli strains, pathogenic for suckling piglets, containing F4ac, F5, F41 and F6 fimbria adhesins and also toxoid β (sensu lato) Clostridium perfringens, type C (produces a‑ and β₁‑, β₂‑toxin).

Composition

Each dose (2 ml) contains:

Active substances:

Porcine rotavirus, serogroup A, strain OSU 6, inactivated                            RP ≥ 1^*

Escherichia coli, serotype O149:K88 (F4ac), inactivated                               RP ≥ 1^*

Escherichia coli, serotype O101:K99 (F5 and F41), inactivated                    RP ≥ 1^* (F5), RP ≥ 1^* (F41)

Escherichia coli, serotype K85:987P (F6), inactivated                                     RP ≥ 1^*

Clostridium perfringens, type C, beta toxoid                                                    RP ≥ 1^{*, **}

F       = fimbrial adhesin

*       RP = Relative potency (ELISA), in comparison with reference serum obtained from vaccinated mice with vaccine batch, which complied in challenge test on target species.

**     minimal listed value complies with potency ≥ 20 IU required by Ph. Eur.

Adjuvant:

Montanide ISA 35 VG     0.52 ml

Target species

Pigs (pregnant gilts and sows)

Indications for use for each target species

For passive immunisation of newborn piglets by active immunisation of pregnant gilts and sows to reduce:

-    Clinical signs (neonatal diarrhoea) and mortality caused by E. coli strains expressing the fimbrial adhesins F4ac, F5, F6 and F41

-    Clinical signs (neonatal diarrhoea, vomiting and anorexia) caused by porcine rotavirus

-    Clinical signs (neonatal diarrhoea, enteritis) and mortality caused by beta toxin (expressed by Clostridium perfringens)

Onset of immunity:

Passive immunity commences with suckling of piglets and is dependent on piglets receiving sufficient colostrum and milk from vaccinated dams after birth.

Protection of piglets for the indications above were demonstrated for:

E. coli strains:                                                               within 12 hours after birth.

Rotavirus:                                                                      at 5 days of age.

Clostridium perfringens, type C, beta toxoid:                at 2 days of age.

Duration of immunity:

Demonstrated based on challenge studies: 3 weeks of age (by serological control till 28 days).

Administration routes and dosage

Vaccine dose:    2 ml

Route of administration: intramuscular administration into the neck muscles behind the ear.

Allow the vaccine to warm up to approximately 15‑25 °C before use and shake the contents well prior to administration. Use sterile injection needle and syringes and administer the vaccine to an area of aseptically treated, clean and dried skin.

Pregnant gilts and sows

Basic vaccination – 2 administrations of one dose at an interval of 2 weeks:

-      first administration 4 weeks before expected farrowing

-      second administration 2 weeks before expected farrowing

Revaccination

-      during subsequent pregnancies: administration of 1 dose 2 weeks prior expected farrowing

Special precautions for storage

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

Do not freeze.

Protect from light.

Shelf life

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

Shelf life after first opening the immediate packaging:                               10 hours.

Packages

10 ml, 50 ml, 100 ml a 250 ml