FrancophonIA/ELRC3.0 huggingface dataset:
English: During a pandemic situation, the resources must be concentrated on a timely and effective monitoring of the safety profile of the influenza vaccines used during the pandemic.
Slovenian: Med pandemijo je treba vire usmeriti v pravočasno in učinkovito spremljanje varnostnih značilnosti cepiv proti gripi, ki se uporabljajo med pandemijo.
English: This can cause bleeding or bruising
Slovenian: To lahko povzroči krvavitve ali modrice.
English: When a person is given the vaccine, the body's natural defence system (immune system) produces its own protection (antibodies) against the disease.
Slovenian: Po cepljenju naravni obrambni sistem telesa (imunski sistem) ustvari lastno zaščito (protitelesa) proti bolezni.
English: Available epidemiological data in adults aged over 20 years have indicated approximately 1 additional case per 100,000 vaccinated subjects.
Slovenian: Epidemiološki podatki, ki so na voljo za odrasle, starejše od 20 let, so nakazali približno 1 dodaten primer na 100.000 cepljenih oseb.
English: Format of the simplified PSUR
Slovenian: Struktura poenostavljenega PSUR
English: The side effects listed below have happened in the days or weeks after vaccination with vaccines given routinely every year to prevent flu.
Slovenian: Neželeni učinki, ki so navedeni spodaj, so se pojavili v dnevih ali tednih po cepljenju s cepivi, s katerimi se vsako leto cepi proti gripi.
English: Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades.
Slovenian: Pandemska gripa je vrsta gripe, ki se pojavi v presledkih, ki trajajo od manj kot 10 let do več desetletij in se hitro širi po vsem svetu.
English: The frequency of side effects was lower in the group of children who received half of the adult dose.
Slovenian: Pogostnost neželenih učinkov je bila nižja v skupini otrok, ki so prejeli polovični odmerek za odrasle.
English: PT “Vaccination failure”.
Slovenian: PT “neuspeh cepljenja”
English: This should include data from ongoing studies, or actual use if applicable, of the pandemic preparedness strains and any safety data relevant to the adjuvant system.
Slovenian: Vključeni morajo biti podatki o potekajočih študijah ali dejanski uporabi (če pride v poštev) seva za pripravljenost na pandemijo in vsi podatki o varnosti, relevantni v zvezi z adjuvantnim sistemom.
English: - Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Slovenian: - Znaki alergijske reakcije so lahko srbeč izpuščaj na koži, težko dihanje in otekanje obraza ali jezika.
English: • Generalised skin reactions including urticaria (hives)
Slovenian: • Generalizirane kožne reakcije, vključno z urtikarijo (koprivnico).
English: Product-specific data can be evaluated during signal work-up.
Slovenian: Za cepivo specifične podatke je mogoče oceniti med obdelavo signalov.
English: When it has been agreed by the CHMP that the S-PSUR is no longer necessary, a full PSUR covering the period since the data lock point of the last routine PSUR will be submitted within a time frame to be agreed with the Rapporteur.
Slovenian: Če je s CHMP dogovorjeno, da S-PSUR niso več potrebna, bo v časovnem okviru, dogovorjenem s poročevalcem, predloženo celotno PSUR; to PSUR bo zajelo obdobje od točke zaključitve zbiranja podatkov za zadnje redno PSUR.
English: All tables will be based on generic and not product-specific data1.
Slovenian: - Vse preglednice bodo temeljile na generičnih podatkih, ne na podatkih, specifičnih za cepivo.1
English: In the unadjuvanted control group, as well as in the adjuvant control group, all animals died or had to be euthanized as they were moribund, three to four days after the start of challenge.
Slovenian: V kontrolnih skupinah so vse živali - tako tiste, ki niso dobile adjuvansa, kot tiste, ki so ga - poginile ali so jih morali žrtvovati, ker so bile tik pred poginom, od tri do štiri dni po začetku provokacije.
English: In children/adolescents (aged up to 20 years), these studies have indicated an additional 1.4 to 8 cases in 100,000 vaccinated subjects.
Slovenian: Pri otrocih/mladostnikih (starih do 20 let) so te študije nakazale od 1,4 do 8 dodatnih primerov na 100.000 cepljenih oseb.
English: Information on outcomes from estimated more than 200,000 women who have been vaccinated during pregnancy is currently limited.
Slovenian: Trenutno je malo informacij o izidih pri okvirno več kot 200.000 ženskah, cepljenih med nosečnostjo.
English: If this applies to you then your vaccination will usually be postponed until you are feeling better.
Slovenian: V tem primeru, bo zdravnik cepljenje običajno odložil, dokler ne boste ozdraveli.
English: If your child receives the vaccine, you should be aware that the side effects may be more intense after the second dose, especially temperature over 38°C.
Slovenian: Če vaš otrok dobi cepivo, morate vedeti, da so lahko neželeni učinki po drugem odmerku izrazitejši, zlasti zvišanje telesne temperature nad 38 °C.
English: If you have not previously received doses of Prepandrix
Slovenian: Če predhodno niste prejeli odmerkov cepiva Prepandrix
English: One dose of 0.5 ml at an elected date.
Slovenian: En odmerek 0,5 ml na izbrani dan.
English: PT “Neuritis”
Slovenian: PT “nevritis”
English: All non-medically confirmed events are those that have been entered into the database by the data-lock point.
Slovenian: - Učinki, ki niso medicinsko potrjeni, so vsi učinki, ki niso bili vneseni v podatkovno bazo do točke zaključitve zbiranja podatkov.
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code: J07BB02.
Slovenian: Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB02
English: Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or foetal or neonatal toxicity.
Slovenian: Podatki, pridobljeni pri nosečnicah, ki so bile cepljene z drugačnimi inaktiviranimi sezonskimi cepivi brez adjuvansa, ne nakazujejo na malformacije ali toksične učinke na plod ali novorojenca.
English: Except for Table 1, all tables will be based on number of reactions (presented on PT level, sorted by System Organ Class [SOC] and High Level Term [HLT]) and not number of cases.
Slovenian: - Razen preglednice 1 bodo vse preglednice temeljile na številu učinkov (predstavljeni po nivoju PT, razvrščeni po organskem sistemu [SOC] in visokonivojskem têrminu [HLT]), ne na številu primerov.
English: If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection.
Slovenian: Če pandemske razmere dopuščajo, je treba cepljenje odložiti pri bolnikih, ki imajo hujše obolenje s povišano telesno temperaturo ali akutno okužbo.
English: Based on the assumption that product name will not be provided in a significant proportion of cases.
Slovenian: Glede na predpostavko, da v velikem deležu primerov ime cepiva ne bo posredovano.
English: Adjupanrix can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Adjupanrix takes due account of the officially declared pandemic strain.
Slovenian: Cepivo Adjupanrix se lahko sprosti v promet le, če SZO/EU uradno razglasi pandemijo gripe in pod pogojem, da imetnik dovoljenja za promet s cepivom Adjupanrix upošteva uradno razglašen pandemski sev.
English: An AS03-containing vaccine containing HA from H1N1v has been administered to women in each trimester of pregnancy.
Slovenian: Cepivo z AS03, ki je vsebovalo HA iz H1N1v, je bilo uporabljeno pri nosečnicah v vseh trimesečjih nosečnosti.
English: If a double dose is given, the injections should be given into opposite limbs preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Slovenian: Če je uporabljen dvojni odmerek, je treba injekciji dati v nasprotni okončini, po možnosti v deltoidno mišico ali anterolateralni del stegna (odvisno od mišične mase).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA): http://www.ema.europa.eu/
English: Outside of the pandemic period, the normal PSUR periodicity and format will be maintained, with a specific review of AESI and possible adverse events related to adjuvants.
Slovenian: Zunaj obdobja pandemije bosta ohranjena normalni razpored in struktura PSUR s specifičnim pregledom posebej zanimivih neželenih učinkov in možnih neželenih učinkov, povezanih z adjuvansi.
English: Pandemic preparedness vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Slovenian: Cepiva za pripravljenost na pandemijo vsebujejo antigene virusa influence, ki se razlikujejo od antigenov virusa influence, ki trenutno kroži med prebivalstvom.
English: Prior to administration, the two components should be mixed.
Slovenian: Pred uporabo morate obe komponenti zmešati skupaj.
English: What you need to know before you receive Adjupanrix
Slovenian: Kaj morate vedeti, preden boste dobili cepivo Adjupanrix
English: There is currently no evidence to indicate that Adjupanrix may be associated with a risk of narcolepsy.
Slovenian: Trenutno ni dokazov, da bi bilo cepivo Adjupanrix morda povezano s tveganjem za narkolepsijo.
English: A line listing of fatal cases will be provided in an Annex.
Slovenian: - V Dodatku bo priložen vrstični izpis smrtnih primerov.
English: At day 42, the anti-HA antibody seroconversion rate was 98%, all subjects were seroprotected and the seroconversion factor was 88.6.
Slovenian: Na 42. dan je bil delež serokonverzije anti-HA protiteles 98 %, vsi preiskovanci so bili serološko zaščiteni in faktor serokonverzije je bil 88,6.
English: Adults from the age of 18 years onwards: one dose of 0.5 ml at an elected date.
Slovenian: Odrasli, starejši od 18 let: en odmerek 0,5 ml na izbrani dan.
English: The second dose should be given after an interval of at least three weeks and up to twelve months after the first dose.
Slovenian: Drugi odmerek je potrebno dati po presledku najmanj treh tednov in do dvanajst mesecev po prvem odmerku.
English: Sächsisches Serumwerk Dresden Branch of GlaxoSmithKline Biologicals Zirkusstraße 40, D-01069 Dresden Germany
Slovenian: Sächsisches Serumwerk Dresden Branch of GlaxoSmithKline Biologicals Zirkusstraße 40, D-01069 Dresden
English: As with all vaccines, Adjupanrix may not fully protect all persons who are vaccinated.
Slovenian: Kot druga cepiva tudi cepivo Adjupanrix morda ne bo popolnoma zaščitilo vseh cepljenih oseb.
English: Adjupanrix can still be given but your response to the vaccine may be poor.
Slovenian: Cepivo Adjupanrix lahko dobite kljub temu, a vaš odziv nanj je lahko šibek.
English: After two priming doses
Slovenian: Po dveh primarnih odmerkih
English: 2.5 ml per vial.
Slovenian: 2,5 ml na vialo.
English: During the pandemic, the applicant will collect clinical safety and effectiveness data of the pandemic vaccine and submit this information to the CHMP for evaluation.
Slovenian: Med pandemijo bo vlagatelj zbiral podatke o klinični varnosti in učinkovitosti pandemskega cepiva in te podatke posredoval v vrednotenje Odboru za zdravila za uporabo v humani medicini (CHMP).
English: In addition, from post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have been reported:
Slovenian: Med spremljanjem interpandemskih trivalentnih cepiv po pridobitvi dovoljenja za promet so poročali tudi o naslednjih neželenih učinkih:
English: Before the vaccine is given, the two parts will be mixed together.
Slovenian: Pred uporabo cepiva je treba oba dela zmešati skupaj.
English: The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke o zdravilu in posodobila navodilo za uporabo, če bo potrebno.
English: At day 180, the seroprotection rate was 13%.
Slovenian: 180. dan je bil delež serokonverzije 13 %.
English: The side effects listed below have happened with H1N1 AS03-containing vaccines.
Slovenian: Neželeni učinki, našteti spodaj, so se pojavili pri cepivih s H1N1, ki vsebujejo AS03.
English: 4.7 Effects on ability to drive and use machines Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or operate machinery.
Slovenian: Nekateri učinki, navedeni v poglavju 4.8, "Neželeni učinki", lahko vplivajo na sposobnost vožnje in upravljanja s stroji.
English: Adjupanrix contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose.
Slovenian: Cepivo Adjupanrix vsebuje manj kot 1 mmol natrija (23 mg) in manj kot 1 mmol kalija (39 mg) na odmerek.
English: Viral shedding into the upper respiratory tract was also reduced in vaccinated animals relative to controls, suggesting a reduced risk of viral transmission.
Slovenian: Pri cepljenih živalih se je v primerjavi s kontrolnimi zmanjšalo tudi izločanje virusa iz zgornjih dihal, kar kaže na manjše tveganje za prenos virusa.
English: Persons previously vaccinated with one or two doses of Prepandrix containing HA derived from a different clade of the same influenza subtype as the pandemic influenza virus:
Slovenian: Osebe, ki so bile predhodno cepljene z enim ali dvema odmerkoma Prepandrixa, ki vsebuje HA iz druge gruče (clade) istega podtipa gripe, kot je pandemski virus influence:
English: Musculoskeletal and connective tissue disorders Very common: arthralgia, myalgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti: artralgija, mialgija
English: Furthermore, in the group of children that received a half dose of vaccine, the rate of subjects with a titre of neutralising antibodies above 1:80 remained high up to 24 months after the first dose.
Slovenian: Poleg tega je v skupini otrok, ki so dobili pol odmerka cepiva, delež preiskovancev s titrom nevtralizirajočih protiteles nad 1:80 ostal visok do 24 mesecev po prvem odmerku.
English: Seroprotection rate*1
Slovenian: Delež serološke zaščite*1
English: • They will give Adjupanrix as an injection into a muscle.
Slovenian: • Cepivo Adjupanrix vam bodo injicirali v mišico.
English: However, following two administrations of a double dose of vaccine, the seroprotection rate at day 42 was 75%.
Slovenian: Po dvakratni uporabi dvojnega odmerka cepiva pa je bil delež serološke zaščite na 42. dan 75 %.
English: However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.
Slovenian: V pandemskih razmerah bo cepljenje morda vseeno upravičeno, vendar ob zagotovitvi opreme za oživljanje, ki mora biti po potrebi nemudoma na voljo.
English: Animal studies with Adjupanrix do not indicate reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih, opravljene s cepivom Adjupanrix ne kažejo na vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Adults aged 18-60 years
Slovenian: Odrasli, stari do 18 do 60 let
English: Month 24
Slovenian: 24. mesec
English: • This will usually be in the upper arm.
Slovenian: • Navadno je to mišica na nadlakti.
English: Uncommon: paraesthesia, somnolence, dizziness
Slovenian: Občasni: parestezije, somnolenca, omotica
English: Twelve and twenty-four months after vaccination, the neutralising antibody titres were as follows:
Slovenian: Dvanajst in štiriindvajset mesecev po cepljenju so bili titri nevtralizirajočih protiteles naslednji:
English: Of the animals receiving adjuvanted vaccine, 87% and 96% were protected against the lethal homologous or heterologous challenge, respectively.
Slovenian: Od živali, ki so prejele cepivo z adjuvansom, jih je bilo proti smrtni homologni provokaciji zaščitenih 87 %, proti heterologni pa 96 %.
English: Epidemiological studies relating to another AS03-adjuvanted vaccine (Pandemrix H1N1, also manufactured in the same facility as Adjupanrix), in several European countries have indicated an increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated individuals.
Slovenian: Epidemiološke študije, povezane z drugim cepivom z adjuvansom AS03 (Pandemrix H1N1, ki ga izdeluje isti obrat kot cepivo Adjupanrix), so v več evropskih državah nakazale večje tveganje za narkolepsijo (s katapleksijo ali brez nje) pri cepljenih osebah v primerjavi z necepljenimi.
English: Adjupanrix is not intended to be given at the same time as some other vaccines.
Slovenian: Cepivo Adjupanrix ni namenjeno za dajanje ob istem času z nekaterimi z drugimi cepivi.
English: Tell the doctor requesting these tests that you have recently received Adjupanrix.
Slovenian: Zdravnika, ki želi opraviti takšne preiskave opozorite, da ste bili pred kratkim cepljeni s cepivom Adjupanrix.
English: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Slovenian: Po vsakem cepljenju ali celo pred njim se lahko pojavi sinkopa (omedlevica), kot psihološki odziv na injiciranje z iglo.
English: Additional side effects in children
Slovenian: Dodatni neželeni učinki in otrocih
English: - Vaccination failure:
Slovenian: - neuspeh cepljenja:
English: narrow SMQ “Non-infectious encephalitis”
Slovenian: ozka SMQ “neinfekcijski encefalitis”
English: There are currently no data available on the use of Adjupanrix in pregnancy.
Slovenian: Trenutno ni podatkov o uporabi cepiva Adjupanrix med nosečnostjo.
English: Based on very limited data, adults aged >80 years may require a double dose of Adjupanrix on an elected date and again after an interval of at least three weeks in order to achieve an immune response (see section 5.1).
Slovenian: Na podlagi zelo omejenih podatkov kaže, da lahko odrasli, starejši od 80 let, potrebujejo za doseganje imunskega odziva dvojni odmerek cepiva Adjupanrix na izbrani datum in znova po presledku vsaj treh tednov (glejte poglavje 5.1).
English: Other medicines and Adjupanrix
Slovenian: Druga zdravila in cepivo Adjupanrix
English: Adjuvants are used to improve the body's response to the vaccine.
Slovenian: Adjuvansi se uporabljajo za izboljšanje imunskega odziva na cepivo.
English: • Problems with your brain and nerves such as inflammation of the central nervous system (encephalomyelitis), inflammation of nerves (neuritis) or a type of paralysis known as ‘GuillainBarré Syndrome'.
Slovenian: • težave z vašimi možgani in živci, kot je vnetje osrednjega živčevja (encefalomielitis), vnetje živcev (nevritis) ali vrsta ohromitve, imenovana Guillain-Barréjev sindrom,
English: Each vaccine dose of 0.5 ml is withdrawn into a 1 ml syringe for injection and administered intramuscularly.
Slovenian: Vsak odmerek cepiva z 0,5 ml izvlecite v 1-ml injekcijsko brizgo in injicirajte intramuskularno.
English: The anti-HA responses were as follows:
Slovenian: Odzivi anti-HA so bili naslednji:
English: Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Slovenian: Kot vsa cepiva ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
English: narrow SMQ “Vasculitis” - Guillain-Barré syndrome: narrow SMQ “Guillain-Barré syndrome” - Demyelination:
Slovenian: ozka SMQ “vaskulitis” - Guillain-Barréjev sindrom: ozka SMQ “Guillain-Barréjev sindrom” - demielinizacija:
English: 1 Geometric Mean Titre
Slovenian: 1 Geometrična sredina titrov
English: The ability to induce protection against homologous and heterologous vaccine strains was assessed non-clinically using ferret challenge models.
Slovenian: Sposobnost za indukcijo zaščite proti homolognim in heterolognim cepilnim sevom so ocenili predklinično s provokacijskim modelom pri belem dihurju.
English: narrow SMQ “Convulsions”
Slovenian: ozka SMQ “konvulzije”
English: A minor infection such as a cold should not be a problem, but your doctor will advise whether you could still be vaccinated with Adjupanrix.
Slovenian: Blažja okužba, npr. prehlad, ne bi smela biti težava, vendar se pred cepljenjem s cepivom Adjupanrix o tem vseeno posvetujte s svojim zdravnikom.
English: - Vasculitis:
Slovenian: - vaskulitis:
English: What Adjupanrix is and what it is used for What you need to know before you receive Adjupanrix How Adjupanrix is given
Slovenian: Kaj je cepivo Adjupanrix in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili cepivo Adjupanrix Kako uporabljati cepivo Adjupanrix
English: If you have any further questions on the use of this vaccine, ask your doctor or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravnikom ali z medicinsko sestro.
English: If you have previously received one or two doses of Prepandrix
Slovenian: Če ste predhodno bili cepljeni z enim ali dvema odmerkoma cepiva Prepandrix
English: One pack of Adjupanrix consists of:
Slovenian: Eno pakiranje cepiva Adjupanrix vsebuje:
English: In this study, cross-reactive immune responses against A/Indonesia/5/2005 were also observed.
Slovenian: V tej študiji so opažali tudi navzkrižne imunske odzive proti A/Indonesia/5/2005.
English: • This vaccine has been prescribed for you only.
Slovenian: • Cepivo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: Against A/Indonesia 21 days after boosting with A/Indonesia N=49
Slovenian: Proti A/Indonesia 21 dni po obnovitvi z A/Indonesia n = 49
English: Adverse reactions from clinical trials with the pandemic preparedness vaccine are listed here below (see section 5.1 for more information on pandemic preparedness vaccines).
Slovenian: Spodaj so navedeni neželeni učinki kliničnih preskušanj s cepivom za pripravljenost na pandemijo (za več informacij o cepivih za pripravljenost na pandemijo glejte poglavje 5.1).
English: If you are not sure, talk to your doctor or nurse before having this vaccine.
Slovenian: Če niste prepričani, se pred cepljenjem posvetujte z zdravnikom ali z medicinsko sestro.
English: Adjupanrix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Slovenian: Cepivo Adjupanrix vsebuje tiomersal Cepivo Adjupanrix kot konzervans vsebuje tiomersal in možno je, da se vam pojavi alergijska reakcija.
English: Seroconversion rates for neutralising antibodies against A/Indonesia/5/2005 were 15.7% and 12.2% for months 12 and 24, respectively.
Slovenian: Deleža serokonverzije za nevtralizirajoča protitelesa proti A/Indonesia/5/2005 sta bila 12. mesec 15,7 % in 24. mesec 12,2 %.
English: Therefore, 6-monthly or annual PSURs falling within the pandemic period will be replaced by monthly “simplified PSURs” (S-PSUR) accompanied by a summary of vaccine distribution.
Slovenian: Med pandemijo bodo zato 6-mesečne ali letne PSUR nadomestila mesečna "poenostavljena
English: The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by means of a 5 ml syringe and by adding it to the vial containing the antigen.
Slovenian: Cepivo zmešate tako, da s 5-ml injekcijsko brizgo izvlečete celotno vsebino viale adjuvansa in jo dodate v vialo z antigenom.
English: The administration of a second half adult or an adult dose did not enhance the reactogenicity, except for rates of general symptoms which were higher after the second dose, particularly for rates of fever in <6 year olds.
Slovenian: Uporaba drugega polovičnega odmerka za odrasle ali polnega odmerka za odrasle ni povečala reaktogenosti, razen stopenj splošnih simptomov, ki so bile višje po drugem odmerku, zlasti kar zadeva deleže zvišane telesne temperature pri mlajših od 6 let.
English: 0, 6 months schedule (D-Pan-H5N1-012)
Slovenian: shema 0, 6 mesecev (D-Pan-H5N1-012)
English: There was no evidence of an increased risk of adverse outcomes in over 100 pregnancies that were followed in a prospective clinical study.
Slovenian: V več kot 100 nosečnostih, ki so jih spremljali med prospektivno klinično študijo, ni bilo dokazov o večjem tveganju neželenih izidov.