Страна: Європейський Союз
мова: англійська
Джерело: EMA (European Medicines Agency)
inactivated influenza A virus/human
IDT Biologika GmbH
QI09AA03
inactivated influenza A virus/human strain: A/Jena/VI5258/2009(H1N1)pdm09
Pigs
Immunologicals, inactivated viral vaccines for pigs, porcine influenza virus
Active immunisation of pigs from the age of 8 weeks onwards against pandemic H1N1 porcine influenza virus to reduce viral lung load and viral excretion.
Authorised
2017-05-17
13 B. PACKAGE LEAFLET 14 PACKAGE LEAFLET FOR: RESPIPORC FLUPAN H1N1 SUSPENSION FOR INJECTION FOR PIGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau GERMANY 2. NAME OF THE VETERINARY MEDICINAL PRODUCT RESPIPORC FLUpan H1N1 suspension for injection for pigs 3. STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS Each dose of 1 ml contains: ACTIVE SUBSTANCE: Inactivated Influenza A virus/human Strain: A/Jena/VI5258/2009(H1N1)pdm09 16–64 HU 1 1 HU – haemagglutinating units in the vaccine. ADJUVANT: Carbomer 971 P NF 2 mg EXCIPIENT: Thiomersal 0.1 mg Clear to slightly turbid, reddish to pale-pink coloured suspension. 4. INDICATION(S) Active immunisation of pigs from the age of 8 weeks onwards against pandemic H1N1 porcine influenza virus to reduce viral lung load and virus excretion. Onset of immunity: 7 days after primary vaccination. Duration of immunity: 3 months after primary vaccination. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS A transient increase in rectal temperature, not exceeding 2 °C, is common after vaccination and this does not persist for more than one day. 15 A transient swelling up to 2 cm 3 may occur at the site of injection, these reactions are common but resolve within 5 days. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - 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). If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surg Прочитайте повний документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT RESPIPORC FLUpan H1N1 suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: ACTIVE SUBSTANCE: Inactivated influenza A virus/human Strain: A/Jena/VI5258/2009(H1N1)pdm09 16–64 HU 1 1 HU – haemagglutinating units in the vaccine. ADJUVANT: Carbomer 971 P NF 2 mg EXCIPIENT: Thiomersal 0.1 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Clear to slightly turbid, reddish to pale-pink coloured suspension. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Pigs. 4.2. INDICATION FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of pigs from the age of 8 weeks onwards against pandemic H1N1 porcine influenza virus to reduce viral lung load and viral excretion. Onset of immunity: 7 days after primary vaccination. Duration of immunity: 3 months after primary vaccination. 4.3. CONTRAINDICATIONS None. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 4.5. SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Not applicable. 3 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 increase in rectal temperature, not exceeding 2 °C, is common after vaccination and this does not persist for more than one day. A transient swelling up to 2 cm 3 may occur at the site of injection, these reactions are common but resolve within 5 days. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - 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 treate Прочитайте повний документ