FrancophonIA/ELRC3.0 huggingface dataset:
English: Apart from a higher average transient increase in body temperature on the day of vaccination or the following day, no adverse reactions other than those mentioned under section 4.6 can be expected following the administration of a double dose of vaccine.
Slovenian: Razen večjega povprečnega prehodnega porasta telesne temperature na dan cepljenja ali naslednji dan ni pričakovati drugih neželenih učinkov kot tistih, opisanih v poglavju 4.6 po dajanju dvojnega odmerka cepiva.
English: The import, sale, supply and/or use of Porcilis AR-T DF is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Slovenian: Uvoz, prodaja, oskrba in/ali uporaba Porcilisa AR-T DF je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/
English: Name and address of the manufacturer of the biological active substances:
Slovenian: Ime in naslov izdelovalca bioloških zdravilnih učinkovin:
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: SPC, so bodisi snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) No 470/2009.
Slovenian: Zdravilna učinkovina je učinkovina biološkega izvora, namenjena za vzbujanje aktivne imunosti, in ni zajeta v Uredbi Sveta (ES) 470/2009.
English: The vaccine should preferably be administered just behind the ear.
Slovenian: Cepivo je najbolje dajati za uho.
English: Shelf life of the veterinary medicinal product as packaged for sale: 5 years Shelf life after first opening the vial: 10 hours.
Slovenian: Rok uporabnosti zdravila za uporabo v veterinarski medicini v pakiranju za prodajo: 5 let Rok uporabnosti po prvem odpiranju viale: 10 ur.
English: Shelf life after first opening the vial: 10 hours.
Slovenian: Rok uporabnosti po prvem odpiranju viale: 10 ur.
English: Administer one dose of 2 ml by intramuscular injection to pigs of 18 weeks of age and older.
Slovenian: Dajte en odmerek po 2 ml intramuskularno prašičem, starim 18 tednov in starejšim.
English: Before use, allow the vaccine to reach room temperature.
Slovenian: Pred uporabo naj se cepivo ogreje na sobno temperaturo.
English: The first injection should be administered 6 weeks before the expected date of farrowing.
Slovenian: Prvi odmerek je treba dati 6 tednov pred pričakovano prasitvijo.
English: 50 ml (25 doses)
Slovenian: 50 ml (25 odmerkov)
English: EU/2/00/026/001 EU/2/00/026/002 EU/2/00/026/003 EU/2/00/026/004
Slovenian: EU/2/00/026/001 EU/2/00/026/002 EU/2/00/026/003 EU/2/00/026/004 EU/2/00/026/005 EU/2/00/026/006
English: Avoid introduction of contamination.
Slovenian: Pazite, da ne pride do kontaminacije.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Slovenian: BESEDILO ''ZDRAVILO SHRANJUJTE IZVEN POGLEDA IN DOSEGA OTROK'' Zdravilo shranjujte izven pogleda in dosega otrok.
English: Do not use after the expiry date stated on the label.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojni.
English: For a full list of excipients, see section 6.1
Slovenian: ≤1 mg Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: The immunogens are incorporated in an adjuvant based on dl-α-tocopherol.
Slovenian: Imunogeni so vgrajeni v adjuvans na osnovi dl-alfa-tokoferola.
English: Revaccination: a single injection of one dose (2 ml) should be carried out 2 to 4 weeks prior to each subsequent farrowing.
Slovenian: Revakcinacija: en odmerek (2 ml) je treba dati 2 do 4 tedne pred vsako naslednjo prasitvijo.
English: Special precautions to be taken by the person administering the medicinal product to animals In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 20 ml (10 doses)
Slovenian: VSEBINA IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 20 ml (10 odmerkov)
English: The vaccine contains a non-toxic recombinant derivative of the Pasteurella multocida toxin and inactivated Bordetella bronchiseptica cells.
Slovenian: Cepivo vsebuje netoksični rekombinantni derivat toksina Pasteurelle multocide in inaktivirane celice Bordetelle bronchiseptice.
English: Shake vigorously before use and at intervals during use.
Slovenian: Dobro pretresite pred uporabo in v razmakih med uporabo.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: BESEDILO ''SAMO ZA ŽIVALI'' TER POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Active substances: - Protein dO (non-toxic deletion derivative of Pasteurella multocida dermonecrotic toxin)
Slovenian: Zdravilne učinkovine: - protein dO (netoksični delecijski derivat dermonekrotičnega toksina bakterije Pasteurella multocida)
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ, ČE STA RAZLIČNA
English: Incompatibilities Do not mix with any other veterinary medicinal products.
Slovenian: Inkompatibilnosti Ne mešajte z drugimi zdravili za uporabo v veterinarski medicini.
English: MARKETING AUTHORISATION NUMBERS EU/2/00/026/001-006
Slovenian: ŠTEVILKE DOVOLJENJA ZA PROMET EU/2/00/026/001-006
English: 20 ml (10 doses) Glass vial 50 ml (25 doses) Glass vial 20 ml (10 doses) PET vial 50 ml (25 doses) PET vial 100 ml (50 doses) PET vial 250 ml (125 doses) PET vial
Slovenian: 20 ml (10 odmerkov), steklena viala 50 ml (25 odmerkov), steklena viala 20 ml (10 odmerkov), viala iz PET 50 ml (25 odmerkov), viala iz PET 100 ml (50 odmerkov), viala iz PET 250 ml (125 odmerkov), viala iz PET
English: PACKAGE SIZE 100 ml (50 doses) 250 ml (125 doses)
Slovenian: VELIKOST PAKIRANJA 100 ml (50 odmerkov) 250 ml (125 odmerkov)
English: Use during pregnancy, lactation or lay Can be used during pregnancy
Slovenian: Uporaba v obdobju brejosti, laktacije in nesnosti Zdravilo se lahko uporablja v obdobju brejosti.
English: ≥6.2 log2 TN titre1
Slovenian: ≥ 6,2 log2 toksin nevtralizirajočega titra1
English: ADVICE ON CORRECT ADMINISTRATION Before use, allow the vaccine to reach room temperature.
Slovenian: NASVET O PRAVILNI UPORABI ZDRAVILA Cepivo pred uporabo ogrejte na sobno temperaturo.
English: Colonisation of the surface of the nasal mucosa by Pasteurella multocida is most often promoted by Bordetella bronchiseptica.
Slovenian: Kolonizacijo površine nosne sluznice s Pasteurello multocido najpogosteje pospeši okužba z Bordetello bronchiseptico.
English: Excipient: Formaldehyde
Slovenian: Formaldehid
English: 150 mg dl-α-tocopherol acetate
Slovenian: 150 mg dl-alfa-tokoferol acetata
English: MANUFACTURER'S BATCH NUMBER Lot
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA
English: 4.2 Indications for use, specifying the target species For the reduction of clinical signs of progressive atrophic rhinitis in piglets by passive oral immunisation with colostrum from dams actively immunised with the vaccine.
Slovenian: 4.2 Indikacije za uporabo, opredelitev ciljne živalske vrste Zmanjšanje kliničnih znakov progresivnega atrofičnega rinitisa pujskov s pasivno peroralno imunizacijo prek kolostruma aktivno imuniziranih mater.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila za uporabo v veterinarski medicini ali odpadnih snovi
English: Primary vaccination: inject one dose (2 ml) per pig, followed by a second injection 4 weeks after the first injection.
Slovenian: Prvo cepljenje: en odmerek (2 ml) za enega prašiča, nato drugi odmerek 4 tedne po prvem.
English: Marketing authorisation holder and manufacturer: Intervet International B.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec: Intervet International B.V.
English: Pigs (sows and gilts).
Slovenian: Prašiči (svinje in mladice)
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
English: Read the package leaflet before use.
Slovenian: Pred uporabo preberite navodila za uporabo.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Slovenian: ODMEREK ZA POSAMEZNE ŽIVALSKE VRSTE TER POT IN NAČIN UPORABE ZDRAVILA
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij O varnosti ter učinkovitosti ob sočasni uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini ni podatkov.
English: To stimulate active immunity in order to provide passive immunity to the progeny against progressive atrophic rhinitis.
Slovenian: Spodbujanje aktivne imunosti za razvoj pasivne imunosti pri potomcih proti progresivnemu atrofičnemu rinitisu.
English: For animal treatment only - to be supplied only on veterinary prescription.
Slovenian: Samo za živali - samo na veterinarski recept.
English: TARGET SPECIES Pigs (sows and gilts)
Slovenian: CILJNA ŽIVALSKA VRSTA Prašiči (svinje in mladice)
English: TARGET SPECIES Pigs (sows and gilts).
Slovenian: CILJNA ŽIVALSKA VRSTA Prašiči (svinje in mladice).
English: For animal treatment only - to be supplied only on veterinary prescription
Slovenian: Samo za živali - samo na veterinarski recept
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Slovenian: Wim de Körverstraat 35 NL-5831 AN Boxmeer NIZOZEMSKA
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis AR-T DF suspension for injection for pigs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Porcilis AR-T DF, suspenzija za injiciranje za prašiče
English: Adjuvant: dl-α-tocopherol acetate
Slovenian: Adjuvans: dl-alfa-tokoferol acetat
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Intervet International B.V.
English: EXP {month/year} Once broached, use within 10 hours.
Slovenian: Načeto/odprto zdravilo uporabite v 10 urah.
English: A mean transient increase in body temperature of 1.5°C, in some pigs up to 3 °C, which could lead to an abortion, can generally be measured on the day of vaccination or the following day.
Slovenian: Na splošno se lahko pri nekaterih prašičih na dan cepljenja ali naslednji dan prehodno poveča telesna temperatura povprečno za 1,5 °C, pri nekaterih prašičih do 3 °C, kar lahko vodi do abortusa.. Na dan cepljenja se lahko zmanjšata aktivnost in tek in se pojavi prehodna oteklina na mestu injiciranja (največji premer je 10 cm), ki traja do dveh tednov.
English: 2 Mean agglutination titre obtained after a single vaccination of a half dose in rabbits
Slovenian: 2Srednji aglutinacijski titer je določen po enkratni vakcinaciji s polovičnim odmerkom pri kuncih.
English: PACKAGE LEAFLET Porcilis AR-T DF suspension for injection for pigs
Slovenian: Porcilis AR-T DF, suspenzija za injiciranje za prašiče
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Slovenian: BESEDILO ''SAMO ZA ŽIVALI'' Samo za živali
English: Name and address of the manufacturer responsible for batch release:
Slovenian: Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije:
English: For the reduction of clinical signs of progressive atrophic rhinitis in piglets by passive oral immunisation with colostrum from dams actively immunised with the vaccine.
Slovenian: Zmanjšanje kliničnih znakov progresivnega atrofičnega rinitisa pujskov s pasivno peroralno imunizacijo prek kolostruma aktivno imuniziranih mater.
English: Sodium chloride Phosphate buffer Simethicone Polysorbate 80
Slovenian: Fosfatni pufer Simetikon
English: Dermonecrotic toxin producing Pasteurella multocida is the pathogen responsible for turbinate atrophy in progressive atrophic rhinitis.
Slovenian: Pasteurella multocida, ki izloča dermonekrotični toksin, povzroča atrofijo nosnih školjk pri progresivnem atrofičnem rinitisu.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis AR-T DF
Slovenian: Porcilis AR-T DF
English: Pharmacotherapeutic group: inactivated bacterial vaccine.
Slovenian: IMUNOLOŠKE LASTNOSTI Farmakoterapevtska skupina: inaktivirano bakterijsko cepivo Oznaka ATCvet: QI09AB04
English: EXPIRY DATE EXP {month/year} Once broached, use within 10 hours.
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Read the package leaflet before use.
Slovenian: KOLIČINA ZDRAVILNEUČINKOVINE Pred uporabo preberite navodilo za uporabo.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE [100 and 250 ml vials]
Slovenian: PODATKI NA STIČNI OVOJNINI [Viale po 100 ml in 250 ml]
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of 2 ml: ≥6.2 log2 TN titre Protein dO (non-toxic deletion derivative of Pasteurella multocida dermonecrotic toxin) ≥5.5 log2 Aggl.
Slovenian: - ≥ 6,2 log2 toksin nevtralizirajočega titra1 proteina dO (netoksični delecijski derivat dermonekrotičnega toksina Pasteurella multocida) - ≥ 5,5 log2 aglutinacijskega titra1 inaktiviranih celic bakterije Bordetella bronchiseptica
English: Shake vigorously before and at intervals during use.
Slovenian: Pred uporabo in občasno med njo dobro pretresite.
English: IMMUNOLOGICAL PROPERTIES
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: Interaction with other medicinal products and other forms of interaction
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI
English: INDICATION(S) Vaccine against progressive atrophic rhinitis.
Slovenian: INDIKACIJE Cepivo proti progresivnemu atrofičnemu rinitisu
English: Cardboard box containing one PET vial of 20 ml, 50 ml, 100 ml or 250 ml.
Slovenian: Zloženka z eno vialo po 20 ml ali 50 ml iz stekla 1. hidrolitične skupine Zloženka z eno vialo po 20 ml, 50 ml, 100 ml ali 250 ml iz tereftalata [PET] Ni nujno, da so v prometu vsa navedena pakiranja.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij O varnosti ter učinkovitosti ob sočasni uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini ni podatkov.
English: Special precautions for use in animals
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
English: Neonatal piglets derive passive immunity via ingestion of colostrum from vaccinated sows/gilts.
Slovenian: Novorojeni pujski pridobijo pasivno imunost s kolostrumom cepljenih svinj/mladic.
English: 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Natrijev klorid
English: C. STATEMENT OF THE MRLs
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL)
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of 2 ml: ≥6.2 log2 TN titre Protein dO ≥5.5 log2 Aggl.
Slovenian: - ≥ 6,2 log2 toksin nevtralizirajočega titra1 proteina dO - ≥ 5,5 log2 aglutinacijskega titra1 inaktiviranih celic bakterije Bordetella bronchiseptica dl-alfa-tokoferol acetata
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: ROUTE(S) OF ADMINISTRATION
Slovenian: NAČIN(I) UPORABE ZDRAVILA
English: titre2
Slovenian: formaldehid
English: INDICATION(S)
Slovenian: DODATEK I
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS [20 and 50 ml vials]
Slovenian: [Viale po 20 ml in 50 ml]
English: In such cases, the Western blot method is negative.
Slovenian: V teh primerih je metoda Western blot negativna.
English: (2015/2016 season)
Slovenian: (sezona 2015/2016)
English: * These reactions usually disappeared within 1-2 days without treatment.
Slovenian: * Te reakcije so navadno izginile v 1 do 2 dneh brez zdravljenja.
English: Component of a multipack, can't be sold separately.
Slovenian: Sestavni del večkratnega pakiranja, ne sme se prodajati ločeno.
English: These reactions are usually mild and only last a few days.
Slovenian: Te reakcije so navadno blage in trajajo le nekaj dni.
English: - Allergic reactions, in very rare cases leading to shock
Slovenian: - Alergijske reakcije, ki v redkih primerih povzročijo šok
English: Vaccine Efficacy*
Slovenian: Učinkovitost cepiva*
English: Table 1: Frequency in adults (18-60 years of age)
Slovenian: Preglednica 1: Pogostnost pri odraslih (18-60 let)
English: If you need a blood test to look for evidence of infection with certain viruses in the first few weeks after vaccination with Optaflu, the result of the test may not be correct.
Slovenian: Če je potreben pregled krvi zaradi znakov okužbe z nekaterimi virusi v prvih tednih po cepljenju s cepivom Optaflu, morda rezultati testov ne bodo pravilni.
English: Vaccine Efficacy = (1 - Relative Risk) x 100 %
Slovenian: Učinkovitost cepiva = (1 - relativno tveganje) x 100 %
English: Seroprotection is generally obtained within 3 weeks, as shown by the pivotal phase III clinical study V58P4 for the adult and elderly population.
Slovenian: Serološka zaščita je navadno dosežena v 3 tednih, kot je pokazala ključna klinična študija III. faze V58P4 za populacijo odraslih in starejših bolnikov.
English: - Fever greater than 39.0°C
Slovenian: - Telesna temperatura nad 39,0 °C
English: Among the overall study population enrolled, the mean age was 33 years, 55% were female, 84% were Caucasian, 7% were Black, 7% were Hispanic, and 2% were of other ethnic origin.
Slovenian: Pri v študijo vključeni populaciji je bila povprečna starost 33 let, 55 % je bilo žensk, 84 % je bilo belcev, 7 % črncev, 7 % ljudi hispanskega porekla in 2 % ljudi drugega etničnega porekla.
English: Rare to <1/1000
Slovenian: Redki do < 1/1.000
English: Adverse reactions are listed according to the following frequency:
Slovenian: Neželni učinki so navedeni po naslednji pogostnosti:
English: Reporting of suspected adverse reactions after authorisation of the medicinal products is important.
Slovenian: Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
English: Very serious side effects
Slovenian: Zelo resni neželeni učinki
English: A multinational (US, Finland, and Poland), randomized, observer-blinded, placebo-controlled trial was performed to assess clinical efficacy and safety of Optaflu during the 2007-2008 influenza season in adults aged 18 to 49 years.
Slovenian: Opravljeno je bilo mednarodno (ZDA, Finska in Poljska), randomizirano, za opazovalca slepo, s placebom nadzorovano preskušanje za oceno klinične učinkovitosti in varnosti cepiva Optaflu v sezoni gripe 2007-2008 pri odraslih osebah, starih od 18 do 49 let.
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Slovenian: Odziv protiteles pri bolnikih z endogeno ali iatrogeno imunosupresijo morda ne bo zadosten.
English: • if you are allergic to influenza vaccine or any of the other ingredients of this vaccine (listed in
Slovenian: •če ste alergični na cepivo proti gripi ali katero koli sestavino tega cepiva (navedeno v poglavju 6);
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: If you take any medicines against cancer (chemotherapy), corticosteroid medicines (such as cortisone) or other medicines affecting the immune system, the immune response of your body may be weakened.
Slovenian: Če uporabljate zdravila proti raku (kemoterapijo), kortikosteroide (recimo kortizon) ali druga zdravila, ki vplivajo na imunski system, bo morda imunski odziv vašega telesa oslabljen.
English: • you should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see Section 2, “Taking other medicines”).
Slovenian: • morate vi povedati zdravniku, če je vaš imunski sistem okvarjen in ali prejemate zdravljenje, ki vpliva na imunski sistem, npr. zdravila proti raku (kemoterapija) ali kortikosteroidna zdravila (glejte poglavje 2, „Jemanje drugih zdravil“);
English: Number of Subjects with Influenza
Slovenian: Število oseb z gripo
English: Optaflu should be used in accordance to Official guidance.
Slovenian: Cepivo Optaflu je treba uporabljati v skladu z uradnimi smernicami.
English: The safety of Optaflu has been assessed in seven randomized, active controlled clinical trials performed as part of the development program.
Slovenian: Varnost cepiva Optaflu so ocenili v sedmih randomiziranih, aktivno nadzorovanih kliničnih preskušanjih, opravljenih kot del razvojnega programa.
English: Date of latest renewal: 01 June 2012
Slovenian: Datum prve odobritve: 1. junij 2007 Datum zadnjega podaljšanja: 1. Junij 2012
English: It is important that procedures are in place to avoid injury from faints.
Slovenian: Pomembno je, da se postopek opravi na mestu, kjer se je možno izogniti poškodbam zaradi omedlevice.
English: For intramuscular use.
Slovenian: Za intramuskularno uporabo.
English: Overall 7253 single doses of Optaflu were administered to 6180 adults aged 18 - 60 years of age and to 1073 elderly (aged 61 years or older).
Slovenian: Skupaj 7253 enkratnih odmerkov cepiva Optaflu so dali 6180 odraslim, starim od 18 do 60 let, in 1073 starejšim osebam, starim 61 let ali več.
English: Other medicines and Optaflu
Slovenian: Druga zdravila in cepivo Optaflu
English: It should be noted that adverse reactions may be intensified.
Slovenian: Treba je biti pozoren na to, da so lahko neželeni učinki okrepljeni.
English: In a repeated-dose toxicity study in rabbits there was no evidence of systemic toxicity and the vaccine was locally well tolerated.
Slovenian: V študijah toksičnosti pri ponavljajočih odmerkih pri kuncih ni bilo dokazov o sistemski toksičnosti in cepivo so lokalno dobro prenašali.