FrancophonIA/ELRC3.0 huggingface dataset:
English: Each pack of VEYVONDI 650 IU contains: - powder in a glass vial with a rubber stopper - 5 mL of solvent in a glass vial with a rubber stopper - one reconstitution device (Mix2Vial)
Slovenian: Vsako pakiranje zdravila VEYVONDI 650 i.e. vsebuje: - prašek v stekleni viali z zamaškom iz gume - 5 ml vehikla v stekleni viali z zamaškom iz gume - en pripomoček za rekonstrukcijo (Mix2Vial)
English: After reconstitution with the 10 mL solvent provided, VEYVONDI contains approximately 130 IU/mL vonicog alfa.
Slovenian: Po rekonstituciji z 10 ml vehikla zdravilo VEYVONDI vsebuje približno 130 i.e./ ml vonikoga alfa.
English: VEYVONDI contains the active substance vonicog alfa, which is a recombinant human von Willebrand factor (rVWF).
Slovenian: Zdravilo VEYVONDI vsebuje zdravilno učinkovino vonikog alfa, ki je rekombinantni humani von Willebrandov faktor (rVWF).
English: NAME OF THE MEDICINAL PRODUCT VEYVONDI 1300 IU powder and solvent for solution for injection vonicog alfa (recombinant human von Willebrand factor)
Slovenian: VEYVONDI 1300 i.e. prašek in vehikel za raztopino za injiciranje vonikog alfa (rekombinantni humani von Willebrandov faktor)
English: Each pack of VEYVONDI 1300 IU contains: - powder in a vial (type I glass), with a butyl rubber stopper - 10 mL of solvent in a vial (type I glass), with a rubber stopper (bromobutyl) - one reconstitution device (Mix2Vial)
Slovenian: Vsako pakiranje zdravila VEYVONDI 1300 IU vsebuje: - prašek v viali (steklo tipa I) z zamaškom iz butilne gume - 10 ml vehikla v viali (steklo tipa I) z zamaškom iz gume (bromobutilne) - en pripomoček za rekonstrukcijo (Mix2Vial)
English: Heart rate increased
Slovenian: Ciljna najvišja raven
English: - Do not store above 30°C.
Slovenian: - Vialo shranjujte pri temperaturah do 30 °C.
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection.
Slovenian: FARMACEVTSKA OBLIKA prašek in vehikel za raztopino za injiciranje Prašek je bel do sivobel liofiliziran prašek.
English: How to store VEYVONDI
Slovenian: Shranjevanje zdravila VEYVONDI
English: After reconstitution with the 5 mL solvent provided, VEYVONDI contains approximately 130 IU/mL vonicog alfa.
Slovenian: Po rekonstituciji s 5 ml vehikla zdravilo VEYVONDI vsebuje približno 130 i.e./ ml vonikoga alfa.
English: What you need to know before you use VEYVONDI 3.
Slovenian: Kaj je zdravilo VEYVONDI in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo VEYVONDI Kako uporabljati zdravilo VEYVONDI Možni neželeni učinki
English: If you forget to use VEYVONDI - Do not infuse a double dose to make up for a forgotten dose.
Slovenian: • Ne infundirajte dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: VEYVONDI 650 IU powder and solvent for solution for injection Each pack contains: - powder in a vial (type I glass), with a butyl rubber stopper - 5 mL of solvent in a vial (type I glass), with a rubber stopper (chlorobutyl) - one reconstitution device (Mix2Vial)
Slovenian: VEYVONDI 650 i.e. prašek in vehikel za raztopino za injiciranje Vsako pakiranje vsebuje: - prašek v viali (steklo tipa I) z zamaškom iz butilne gume, - 5 ml vehikla v viali (steklo tipa I) z zamaškom iz (klorobutilne) gume, - en pripomoček za rekonstrukcijo (Mix2Vial).
English: 0.80 - 1 IU/mL Δ
Slovenian: 0,80-1 i.e./ml b
English: 0.60 IU/mL
Slovenian: 0,60 i.e./ml
English: Talk to your doctor before using VEYVONDI.
Slovenian: Pred začetkom uporabe zdravila VEYVONDI se posvetujte z zdravnikom.
English: 0.40 IU/mL
Slovenian: 0,40 i.e./ml
English: Inspect the syringe visually for particulate matter; the solution in the syringe should be clear.
Slovenian: Raztopina v brizgi mora biti bistra.
English: Table 3 Recommended Target Trough Plasma Levels of VWF:RCo and FVIII:C and Minimum Duration of Treatment for Subsequent Maintenance Doses for the Prevention of Excessive Bleeding During and After Surgery
Slovenian: Priporočene ciljne ravni VWF:RCo in FVIII:C v plazmi in najkrajše trajanje zdravljenja pri nadaljnjih vzdrževalnih odmerkih za preprečevanje čezmerne krvavitve po kirurškem posegu
English: For prevention of excessive bleeding in case of elective surgery, within 3 hours prior to initiation of any surgical procedure, the FVIII:C levels should be assessed.
Slovenian: Za preprečevanje čezmerne krvavitve moramo ravni FVIII:C določiti v 3 urah pred začetkom katerega koli kirurškega posega.
English: FVIII:C Target Peak Plasma
Slovenian: Ciljna najnižja raven FVIII:C v plazmi
English: 0.50 IU/mL Δ
Slovenian: 0,40-0,50 i.e./ml Δ
English: FVIII:C Target Peak Plasma Level a
Slovenian: Ciljna najvišja raven FVIII:C v plazmi a
English: The powder is a white to off-white lyophilized powder The solvent is a clear and colourless solution.
Slovenian: Vehikel je bistra in brezbarvna raztopina.
English: Vomiting
Slovenian: Trombogenost
English: Binding antibodies against impurities such as rFurin, CHO-protein or mouse IgG were not observed after treatment with VEYVONDI.
Slovenian: Po zdravljenju z zdravilom VEYVONDI niso ugotovili vezavnih protiteles proti nečistotam, kot so rFurin, beljakovine CHO ali mišji IgG.
English: Cardiac disorders
Slovenian: Srčne bolezni tahikardija pogosti
English: Table 2 Recommended Target Peak Plasma Levels of VWF:RCo and FVIII:C to be Achieved Prior to Surgery for the Prevention of Excessive Bleeding During and After Surgery
Slovenian: Priporočljive ciljne najvišje ravni VWF:RCo in FVIII:C v plazmi, ki jih je treba doseči pred kirurškim posegom, da preprečimo čezmerne krvavitve med kirurškim posegom in po njem
English: 1 vial contains 650 IU vonicog alfa, approx. 130 IU/mL after reconstitution with 5 mL water for Injections
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala vsebuje 650 i.e. vonikoga alfa, približno 130 i.e./ml po rekonstituciji s 5 ml vode za injekcije Specifična aktivnost: približno 110 i.e. VWF:RCo/mg beljakovin
English: 0.50 IU/mL
Slovenian: 0,50 i.e./m l
English: VEYVONDI 1300 IU powder and solvent for solution for injection Each pack contains: - powder in a vial (type I glass), with a butyl rubber stopper
Slovenian: VEYVONDI 1300 i.e. prašek in vehikel za raztopino za injiciranje Vsako pakiranje vsebuje: - prašek v viali (steklo tipa I) z zamaškom iz butilne gume, - 10 ml vehikla v viali (steklo tipa I) z zamaškom iz (bromobutilne) gume, - en pripomoček za rekonstrukcijo (Mix2Vial).
English: Inspect the syringe visually for particulate matter; the solution should be clear and colourless.
Slovenian: Raztopina v brizgi mora biti bistra in brez barve.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: PRILOGA II A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL LABEL (10 mL)
Slovenian: OZNAKA VIALE Z VEHIKLOM (10 ml)
English: Discard the empty solvent vial.
Slovenian: Zavrzite prazno vialo z vehiklom.
English: Inhibitors (antibodies) against the VWF may occur in some patients receiving the medicine.These inhibitors, especially at high levels, could cause the treatment to stop working properly.
Slovenian: Zaradi teh zaviralcev, zlasti če se pojavijo v visokih koncentracijah, zdravilo ne deluje več pravilno.
English: 0.30 IU/mL
Slovenian: 0,30 i.e./ml
English: VEYVONDI (Study 071001)
Slovenian: Faza 3 FK80 zdravilo VEYVONDI (študija 071001)
English: NA
Slovenian: SD
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL LABEL (5mL)
Slovenian: OZNAKA VIALE Z VEHIKLOM (5 ml)
English: 9 Leaving the VEYVONDI vial (containing the reconsituted product) on your flat work surface, connect the syringe to the clear plastic connector and turning the syringe clockwise.
Slovenian: 9 Vialo zdravila VEYVONDI (ki vsebuje rekonstituirano zdravilo) položite na ravno delovno površino.
English: Major > 0.50 IU/mL
Slovenian: 0,50 i.e./ml
English: Check with your doctor if you are not sure.
Slovenian: Če o tem niste prepričani, se posvetujte z zdravnikom.
English: EU/1/18/1298/002
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/18/1298/001 EU/1/18/1298/002
English: The vaccine would be given according to official recommendations.
Slovenian: Cepivo je treba dajati v skladu z uradnimi priporočili.
English: It should only be used once a flu pandemic has been officially declared by the World Health Organization or European Union (EU).
Slovenian: Uporablja se samo, če je pandemijo gripe uradno razglasila Svetovna zdravstvena organizacija ali Evropska unija (EU).
English: One main study in adults included 561 healthy volunteers, 281 of whom were over the age of 60 years.
Slovenian: V eni glavni študiji z odraslimi je sodelovalo 561 zdravih prostovoljcev, od katerih jih je bilo 281 starejših od 60 let.
English: Every year, the European Medicines Agency (EMA) will review any new information that may become available and this summary will be updated as necessary.
Slovenian: Evropska agencija za zdravila (EMA) bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo, in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
English: The vaccine contains a flu strain called A/VietNam/1203/2004 (H5N1).
Slovenian: Cepivo vsebuje sev gripe, imenovan A/VietNam/1203/2004 (H5N1).
English: The vaccine must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as formaldehyde, benzonase or sucrose.
Slovenian: Cepivo se ne sme dajati osebam, ki so imele anafilaktično reakcijo (hudo alergijsko reakcijo) na katero koli sestavino cepiva ali na katero koli izmed snovi v sledeh (v zelo nizkih koncentracijah) cepiva, npr. formaldehid, benzonazo ali saharozo.
English: They can then test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing the pandemic is included.
Slovenian: To cepivo lahko nato preizkusijo, da bi preverili odziv ljudi nanj, na podlagi česar lahko predvidijo, kako se bodo ti odzvali, ko se bo pojavil sev gripe, ki povzroča pandemijo.
English: The study also looked at the effect of a booster dose given after twelve months in some of the children.
Slovenian: V študiji so proučevali tudi učinek poživitvenega odmerka, injiciranega po 12 mesecih, pri nekaterih otrocih.
English: This is a special type of vaccine that is designed to help with the management of a future pandemic.
Slovenian: To je posebna vrsta cepiva, ki je izdelana za pomoč pri nadzorovanju morebitne pandemije.
English: Before a pandemic starts, nobody knows which strain of flu virus will be involved, so pharmaceutical companies cannot prepare the correct vaccine in advance.
Slovenian: Pred začetkom pandemije ni znano, kateri sev virusa gripe se bo razvil, zato farmacevtske družbe ne morejo vnaprej pripraviti ustreznega cepiva.
English: It contains influenza (flu) viruses that have been inactivated (killed).
Slovenian: Vsebuje viruse gripe, ki so bili inaktivirani (uničeni).
English: Although levels of antibodies slowly fell over the year after vaccination, a booster dose after 12 months resulted in protective levels of antibodies in 93 to 100% of children who received it.
Slovenian: Čeprav so ravni protiteles v letu po cepljenju počasi padle, je poživitveni odmerek, injiciran po 12 mesecih, zagotovil zaščitne ravni protiteles pri 93 do 100 % otrok, ki so ga prejeli.
English: When a person is given the vaccine, the immune system recognises the inactivated virus as ‘foreign' and makes antibodies against it.
Slovenian: Ko oseba prejme cepivo, imunski sistem prepozna inaktivirani virus kot „tujek“ in proti njemu tvori protitelesa.
English: The main measure of effectiveness was the production of protective levels of antibodies 21 days after the second vaccination.
Slovenian: Glavno merilo učinkovitosti je bilo tvorjenje zaščitnih ravni protiteles 21 dni po drugem cepljenju.
English: If a pandemic has started, however, it may be appropriate to give the vaccine to these patients, as long as facilities for resuscitation are available.
Slovenian: Ob pojavu pandemije pa bo cepljenje teh bolnikov morda vseeno upravičeno, vendar mora biti na voljo oprema za oživljanje.
English: This means that, because the vaccine is a mock up and does not yet contain the strain of flu virus that is causing a pandemic, it has not been possible to obtain full information about the final pandemic vaccine.
Slovenian: Do tega je prišlo, ker gre za modelno cepivo, ki še ne vsebuje seva virusa gripe, ki utegne povzročiti pandemijo, zato ni bilo mogoče pridobiti vseh informacij o končnem pandemičnem cepivu.
English: whole virion influenza virus, propagated in vero cells (continuous cell line of mammalian origin), inactivated, containing antigen of pandemic strain
Slovenian: celoten viron virusa gripe, razmnožen v celicah Vero (neprekinjena celična linija sesalskega izvora), inaktiviran, vsebuje antigen pandemičnega seva
English: According to criteria laid down by the Committee for Medicinal Products for Human Use (CHMP), a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of adults for it to be considered suitable.
Slovenian: V skladu z merili, ki jih je določil Odbor za zdravila za uporabo v humani medicini (CHMP), je modelno cepivo ustrezno učinkovito le, če zagotovi zaščitno raven protiteles pri vsaj 70 % odraslih.
English: This vaccine is the same as the Celvapan H5N1 mock-up vaccine, which was previously authorised in the European Union (EU).
Slovenian: Cepivo je enako modelnemu cepivu Celvapan H5N1, ki je že bilo odobreno v Evropski uniji (EU).
English: The full EPAR for Pandemic Influenza Vaccine H5N1 Baxter AG can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila Pandemic Influenza Vaccine H5N1 Baxter AG je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: At 21 days after the second injection, 72% of the adults below 60 years of age (192 out of 265) and 74% of those above 60 years of age (200 out of 270) had levels of antibodies that would protect them against H5N1.
Slovenian: Na 21. dan po drugi injekciji so pri 72 % (192 od 265) odraslih, mlajših od 60 let, in 74 % (200 od 270) oseb, starejših od 60 let, nastale ravni protiteles, ki bi jih ščitile pred virusom H5N1.
English: When the company that makes Pandemic Influenza Vaccine H5N1 Baxter AG includes the flu strain responsible for a pandemic in the vaccine, it will collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.
Slovenian: Ko bo družba, ki izdeluje cepivo Pandemic Influenza Vaccine H5N1 Baxter AG, vanj vključila sev gripe, odgovoren za pandemijo, bo zbrala informacije o varnosti in učinkovitosti končnega pandemičnega cepiva in jih predložila CHMP v oceno.
English: This vaccine contains a virus called H5N1 that has been inactivated (killed) so that it does not cause any disease.
Slovenian: Cepivo vsebuje inaktivirani (uničeni) virus H5N1, ki ne povzroča nobene bolezni.
English: The second main study involved 305 children aged 9 to 17 years, 306 aged 3 to 8 years and 73 aged 6 to 35 months, and also examined the effect of two 7.5 microgram doses of the vaccine 21 days apart.
Slovenian: V drugi glavni študiji, v katero je bilo vključenih 305 otrok, starih 9 do 17 let, 306 otrok, starih 3 do 8 let, in 73 otrok, starih 6 do 35 mesecev, so tudi proučevali učinek dveh 7,5-mikrogramskih odmerkov cepiva, injiciranih v razmiku 21 dni.
English: For more information about treatment with Pandemic Influenza Vaccine H5N1 Baxter AG, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Pandemic Influenza Vaccine H5N1 Baxter AG preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The most common side effects with Pandemic Influenza Vaccine H5N1 Baxter AG in adults (seen in more than 1 person in 10) are headache, fatigue (tiredness) and pain at the site of the injection.
Slovenian: Najpogostejši neželeni učinki zdravila Pandemic Influenza Vaccine H5N1 Baxter AG pri odraslih (opaženi pri več kot 1 osebi od 10) so glavobol, utrujenost in bolečina na mestu injiciranja.
English: This is a summary of the European public assessment report (EPAR) for Pandemic Influenza Vaccine H5N1 Baxter AG.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pandemic Influenza Vaccine H5N1 Baxter AG.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pandemic Influenza Vaccine H5N1 Baxter AG on 16 October 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Pandemic Influenza Vaccine H5N1 Baxter AG, veljavno po vsej Evropski uniji, odobrila dne 16. oktobra 2009.
English: The CHMP decided that Pandemic Influenza Vaccine H5N1 Baxter AG's benefits are greater than its risks in all age groups investigated and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Pandemic Influenza Vaccine H5N1 Baxter AG pri vseh proučevanih starostnih skupinah večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: The company that made the Celvapan H5N1 mock-up vaccine has agreed that its scientific data can be used for Pandemic Influenza Vaccine H5N1 Baxter AG (‘informed consent').
Slovenian: Družba, ki proizvaja modelno cepivo Celvapan H5N1, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za cepivo Pandemic Influenza Vaccine H5N1 Baxter AG („uporaba dokumentacije s soglasjem“).
English: Similarly in children, after the second 7.5-microgram dose, 85% of children aged 9 to 17 years, 73% of those 3 to 8 years, and 69% of those aged 6 to 35 months had protective levels of antibodies 21 days after the second injection.
Slovenian: Podobno je bilo pri otrocih, kjer so 21 dni po drugem 7,5-mikrogramskem odmerku zaščitne ravni protiteles nastale pri 85 % otrok, starih 9 do 17 let, 73 % otrok, starih 3 do 8 let, in 69 % otrok, starih 6 do 35 mesecev.
English: A flu pandemic happens when a new type (strain) of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Slovenian: Do pandemije gripe pride, ko se pojavi novi sev virusa gripe, ki se med ljudmi hitro širi, ker proti njemu niso imuni (zaščiteni).
English: Pandemic Influenza Vaccine H5N1 Baxter AG is given by injection into the shoulder muscle or thigh in two doses, at least three weeks apart.
Slovenian: Cepivo Pandemic Influenza Vaccine H5N1 Baxter AG se injicira v hrbtno mišico ali stegno v dveh odmerkih v razmiku najmanj treh tednov.
English: The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again.
Slovenian: Ob ponovni izpostavitvi virusu jih bo imunski sitem tako tvoril hitreje.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pandemic Influenza Vaccine H5N1 Baxter AG, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Pandemic Influenza Vaccine H5N1 Baxter AG in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The viruses used in Pandemic Influenza Vaccine H5N1 Baxter AG are grown in mammal cells (‘vero cells'), unlike those in some other flu vaccines, which are grown in hen's eggs.
Slovenian: Viruse, ki so uporabljeni v zdravilu Pandemic Influenza Vaccine H5N1 Baxter AG, gojijo v celicah sesalcev („celicah Vero“), medtem ko viruse, uporabljene v nekaterih drugih cepivih proti gripi, gojijo v kokošjih jajcih.
English: The study looked at the ability of two 7.5 microgram doses of the vaccine, given 21 days apart, to trigger the production of antibodies (‘immunogenicity').The main measures of effectiveness were the levels of antibodies against the flu virus in the blood before vaccination, on the day of the second injection (day 21), and 21 days after the second vaccination (day 42).
Slovenian: Glavna merila učinkovitosti so bile koncentracije protiteles proti virusu gripe v krvi bolnikov pred cepljenjem, na dan drugega injiciranja (21. dan) in 21 dni po drugem cepljenju (42. dan).
English: The study showed that Pandemic Influenza Vaccine H5N1 Baxter AG produced an antibody response that met these criteria.
Slovenian: Študija je pokazala, da je cepivo Pandemic Influenza Vaccine H5N1 Baxter AG izzvalo odziv protiteles, ki izpolnjuje ta merila.
English: What measures are being taken to ensure the safe and effective use of Pandemic Influenza Vaccine H5N1 Baxter AG?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pandemic Influenza Vaccine H5N1 Baxter AG?
English: For the full list of all side effects reported with Pandemic Influenza Vaccine H5N1 Baxter AG, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Pandemic Influenza Vaccine H5N1 Baxter AG, glejte navodilo za uporabo.
English: Pandemic Influenza Vaccine H5N1 Baxter AG has been authorised under ‘Exceptional Circumstances'.
Slovenian: Cepivo Pandemic Influenza Vaccine H5N1 Baxter AG je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pandemic Influenza Vaccine H5N1 Baxter AG.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Pandemic Influenza Vaccine H5N1 Baxter AG, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: What benefit has Pandemic Influenza Vaccine H5N1 Baxter AG shown during the studies?
Slovenian: Kakšne koristi je zdravilo Pandemic Influenza Vaccine H5N1 Baxter AG izkazalo med študijami?
English: Pandemic Influenza Vaccine H5N1 Baxter AG is a vaccine that is given by injection.
Slovenian: Pandemic Influenza Vaccine H5N1 Baxter AG je cepivo, ki se daje z injekcijo.
English: A risk management plan has been developed to ensure that Pandemic Influenza Vaccine H5N1 Baxter AG is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe cepiva Pandemic Influenza Vaccine H5N1 Baxter AG je bil pripravljen načrt obvladovanja tveganj.
English: Pandemic Influenza Vaccine H5N1 Baxter AG is a vaccine to prevent ‘pandemic' flu.
Slovenian: Pandemic Influenza Vaccine H5N1 Baxter AG je cepivo, ki se uporablja za preprečevanje pandemične gripe.
English: Baxter AG will have to be replaced by the strain causing the pandemic before the vaccine can be used.
Slovenian: Med pandemijo bo treba sev virusa v cepivu Pandemic Influenza Vaccine H5N1 Baxter AG nadomestiti s sevom, ki povzroča pandemijo, preden bo cepivo mogoče uporabiti.
English: Other information about Pandemic Influenza Vaccine H5N1 Baxter AG
Slovenian: Druge informacije o zdravilu Pandemic Influenza Vaccine H5N1 Baxter AG
English: Why has Pandemic Influenza Vaccine H5N1 Baxter AG been approved?
Slovenian: Zakaj je bilo zdravilo Pandemic Influenza Vaccine H5N1 Baxter AG odobreno?
English: What is the risk associated with Pandemic Influenza Vaccine H5N1 Baxter AG?
Slovenian: Kakšna tveganja so povezana z zdravilom Pandemic Influenza Vaccine H5N1 Baxter AG?