Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Inactivated whole cells of Haemophilis parasuis serotype 5, strain 4800
Intervet Ireland Limited
QI09AB07
Inactivated whole cells of Haemophilis parasuis serotype 5, strain 4800
. enzyme-linked immunosorbent assay unit/dose
Suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Pigs
actinobacillus/haemophilus vaccine
Immunological - Inactivated Vaccine
Authorised
2004-03-04
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Glässer Vet Suspension for injection for pigs (DK-FI-NO) Porcilis Glässer Suspension for injection for pigs (AT-BE-DE-EL-ES-FR-IE-LU-NL-PT-UK-CY- CZ-SK-SI-HU-PL-EE-LV) Porsilis Glässer Suspension for injection for pigs (IT) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 2 ml ACTIVE SUBSTANCE(S): Inactivated whole bacterial cells of _Haemophilus parasuis_ serotype 5, strain 4800: 0.05 mg total nitrogen, inducing 9.1 Elisa Units * . ADJUVANT: 150 mg dl- -tocopheryl acetate EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection Appearance: aqueous, white or nearly white suspension 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs and sows. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pigs: Active immunisation of pigs to reduce typical lesions of Glässer’s disease caused by _Haemophilus _ _parasuis_ serotype 5. Onset of immunity: 2 weeks after completion of vaccination. Duration of immunity: 14 weeks after completion of vaccination. Sows: For passive immunisation of the progeny of vaccinated sows and gilts to reduce infection, mortality, clinical signs and typical lesions of Glässer disease caused by _Haemophilus parasuis_ serotype 5 and to reduce clinical signs and mortality caused by _Haemophilus parasuis_ serotype 4. Onset of immunity: After birth and sufficient uptake of colostrum. Duration of immunity has been demonstrated at 4 weeks of age against serotype 4 and at 6 weeks of age against serotype 5. 4.3 CONTRAINDICATIONS None. * ELISA units = mean antibody titre (log2 value) in the potency test in mice. 4.4 SPECIAL WARNINGS None 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Vaccinate only healthy animals. In the event of anaphylactic reaction consult your veterinarian. 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 th Lue koko asiakirja