FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 2 January 2001
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 2. januar 2001
English: This helps your body to increase the CD4 cell count in your blood.
Slovenian: To pomaga vašemu telesu, da poveča število celic CD4 v krvi.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal
Slovenian: Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: If you have any of the symptoms listed above or any other symptoms that worry you:
Slovenian: Če imate katerega od zgoraj naštetih simptomov ali kakršnekoli druge simptome, ki vas skrbijo:
English: Write your doctor's details below:
Slovenian: Spodaj si zapišite podatke o svojem zdravniku:
English: If you are breast-feeding, or thinking about breast-feeding:
Slovenian: Če dojite ali razmišljate o dojenju:
English: However, it is not clear whether these cases were due to treatment with these medicinal products or to the underlying HIV disease.
Slovenian: Vendar ni pojasnjeno, če so bili ti primeri posledica zdravljenja s temi zdravili ali posledica osnovne HIV bolezni.
English: The anaemia may necessitate transfusions.
Slovenian: Zaradi anemije utegnejo biti potrebne transfuzije.
English: Median Change vRNA (log10 c/mL)
Slovenian: Mediana sprememba vRNA (log10 c/ml)
English: 2) you get one or more symptoms from at least TWO of the following groups
Slovenian: 2) opazite enega ali več simptomov iz vsaj DVEH naslednjih skupin:
English: • difficulty in sleeping (insomnia)
Slovenian: • težave s spanjem (nespečnost),
English: Grunwaldzka 189 , 60-322 Poznan, Poland
Slovenian: Grunwaldzka 189 , 60-322 Poznan, Poljska
English: In this patient population, hypersensitivity reactions are particularly difficult to identify.
Slovenian: tej populaciji bolnikov je preobčutljivostne reakcije še posebej težko prepoznati.
English: These symptoms are probably caused by the body's immune system becoming stronger, so that the body starts to fight these infections.
Slovenian: Ti simptomi so verjetno posledica okrepitve imunskega sistema, zaradi česar se organizem začne boriti proti tem okužbam.
English: What Trizivir is and what it is used for
Slovenian: Kaj je zdravilo Trizivir in za kaj ga uporabljamo
English: If you have taken Trizivir during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Slovenian: Če ste zdravilo Trizivir jemali med nosečnostjo, vas lahko zdravnik naroči na redne preiskave krvi in druge diagnostične preiskave, da bo spremljal razvoj vašega otroka.
English: Following discontinuation of abacavir, the symptoms of the reaction should be treated according to local standard of care.
Slovenian: Po prekinitvi zdravljenja z abakavirjem, je treba simptome reakcije obravnavati v skladu z lokalnimi standardi oskrbe.
English: Take the tablets at regular times, leaving approximately 12 hours between each tablet.
Slovenian: Tablete jemljite v rednih presledkih; med eno in drugo tableto naj mine približno 12 ur.
English: Due to the high proportion of premature discontinuation (42 % of patients discontinued randomised treatment by week 48), no definitive conclusion can be drawn regarding the equivalence between the treatment regimens at week 48.
Slovenian: Zaradi visokega odstotka prezgodnjih prekinitev zdravljenja (pri 42 % bolnikov je bilo randomizirano zdravljenje prekinjeno v 48. tednu) v 48. tednu ni bilo mogoče sprejeti dokončnih zaključkov o ekvivalentnosti obeh zdravljenj.
English: A small amount of the ingredients in Trizivir can also pass into your breast milk.
Slovenian: Majhna količina sestavin zdravila Trizivir lahko prehaja v materino mleko.
English: No unexpected adverse reactions were reported.
Slovenian: pri čemer niso poročali o nobenih nepričakovanih neželenih učinkih.
English: CD4 cells are a type of white blood cell that are important in helping your body to fight infection.
Slovenian: Celice CD4 so vrsta belih krvnih celic, pomembnih za premagovanje okužb.
English: • probenecid, to treat gout and similar conditions, and given with some antibiotics to make them more effective
Slovenian: • probenecid za zdravljenje protina in podobnih stanj ali v kombinaciji z nekaterimi antibiotiki za povečanje njihove učinkovitosti,
English: They are listed by body system, organ class and absolute frequency.
Slovenian: Navedene so glede na organski sistem in absolutno pogostnost.
English: • if they are also taking anti-inflammatory medicines called corticosteroids
Slovenian: • ki jemljejo tudi protivnetna zdravila, imenovana kortikosteroidi,
English: It can be life-threatening, causing failure of internal organs.
Slovenian: Lahko je smrtno nevarna in povzroči lahko odpoved notranjih organov.
English: It cannot be excluded that abacavir may increase the risk of having a heart attack.
Slovenian: Ne moremo izključiti, da bi bil abakavir povezan s povečanim tveganjem za srčni infarkt.
English: If you have stopped taking Trizivir for any reason - especially because you think you are having side effects, or because you have other illness:
Slovenian: Če ste zdravilo Trizivir nehali jemati zaradi kakršnegakoli razloga - še zlasti če menite, da imate neželene učinke, ali ker imate druge bolezni:
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time
Slovenian: Če predložitev PSUR in posodobitev RMP sovpadata, se ju lahko predloži istočasno.
English: Trizivir helps to control your condition.
Slovenian: Zdravilo Trizivir pomaga, da je vaše stanje pod nadzorom.
English: It is rare; if it happens, it usually develops after a few months of treatment.
Slovenian: Če se pojavi, se po navadi razvije po nekaj mesecih zdravljenja.
English: These haematological effects are not usually observed before four to six week's therapy.
Slovenian: Ti hematološki učinki se navadno ne pojavijo prej kot po štirih do šestih tednih zdravljenja.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: SIDE 1
Slovenian: STRAN 1
English: There was no significant difference in the time to first virologic failure (p=0.73, log-rank test) between the 2 arms.
Slovenian: Čas do prvega pojava virološkega neuspeha se med obema skupinama ni pomembneje razlikoval (p = 0,73, log-rank test).
English: Hypersensitivity Reactions (see also section 4.8 ):
Slovenian: Preobčutljivostne reakcije (glejte tudi poglavje 4.8):
English: Not everyone responds to treatment with Trizivir in the same way.
Slovenian: Na zdravilo Trizivir se ne odzovejo vsi ljudje enako.
English: The effects of higher doses are not known.
Slovenian: Učinki večjih odmerkov niso znani.
English: For patients with advanced symptomatic HIV disease, it is generally recommended that blood tests are performed at least every two weeks for the first three months of therapy and at least monthly thereafter.
Slovenian: Pri bolnikih z napredovalo simptomatsko HIV boleznijo je priporočljivo, da se krvne preiskave v prvih treh mesecih zdravljenja opravljajo vsaj vsaka dva tedna, pozneje pa najmanj enkrat na mesec.
English: Based on the above patients are advised to contact their physician immediately to determine whether they should stop taking abacavir if:
Slovenian: Na podlagi omenjenega je treba bolnikom naročiti, naj se takoj posvetujejo s svojim zdravnikom, da bodo ugotovili, ali morajo prenehati jemati abakavir, če:
English: Trizivir should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine.
Slovenian: Zdravila Trizivir se ne sme jemati skupaj s katerimkoli zdravilom, ki vsebuje lamivudin ali z zdravilom, ki vsebuje emtricitabin.
English: Studies with abacavir demonstrate a CSF to plasma AUC ratio of between 30 to 44 %.
Slovenian: Študije z abakavirjem so pokazale razmerje AUC med CST in plazmo med 30 do 44 %.
English: Trizivir can be taken with or without food.
Slovenian: Zdravilo Trizivir se lahko jemlje s hrano ali brez nje.
English: Hertfordshire, SG 12 0DJ, UK
Slovenian: Hertfordshire, SG 12 0DJ, Velika Britanija ali
English: Sorbitol solution (3.2 g, 10.2 g, 13.4 g)/ Lamivudine
Slovenian: Raztopina sorbitola (3,2 g , 10,2 g, 13,4 g)/lamivudin
English: HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Slovenian: Okužba s HIV se širi s spolnimi stiki z okuženo osebo ali z okuženo krvjo (npr. s skupno uporabo injekcijskih igel).
English: If your doctor advises that you can start taking Trizivir again, you may be asked to take your first doses in a place where you will have ready access to medical care if you need it.
Slovenian: Če vam zdravnik svetuje, da začnite zdravilo Trizivir jemati znova, bo morda poskrbel, da prve odmerke vzamete v okolju, v katerem je na voljo zdravstvena oskrba, če bi jo potrebovali.
English: It is important to read the information on the other side of this leaflet under ‘Other possible side effects of Trizivir'.
Slovenian: Pomembno je, da preberete informacije na drugi strani tega navodila pod naslovom "Drugi možni neželeni učinki zdravila Trizivir".
English: Routine risk minimisation activities
Slovenian: Rutinske aktivnosti za zmanjšanje tveganja
English: Frequencies are defined as very common (> 1/10), common (> 1/100 to < 1/10), uncommon (> 1/1000 to < 1/100), rare (> 1/10,000 to < 1/1000), very rare (< 1/10,000).
Slovenian: Pogostnost je definirana kot: zelo pogosti (> 1/10), pogosti (> 1/100 do < 1/10), občasni (> 1/1.000 do < 1/100),
English: Patients receiving Trizivir should be frequently examined and questioned for signs of lipoatrophy.
Slovenian: Bolnike, ki prejemajo zdravilo Trizivir, je treba pogosto pregledovati in vprašati po znakih lipoatrofije.
English: You need to know about important signs and symptoms to look out for while you are taking Trizivir.
Slovenian: Poznati morate pomembne znake in simptome, na katere morate biti pozorni med jemanjem zdravila Trizivir.
English: Trizivir and similar medicines may cause side effects in unborn babies.
Slovenian: Zdravilo Trizivir in podobna zdravila imajo lahko neželene učinke pri nerojenih otrocih.
English: However, their main antiviral activity is through incorporation of the monophosphate form into the viral DNA chain, resulting in chain termination.
Slovenian: Glavni način njihovega protivirusnega delovanja je vključitev monofosfatne oblike v verigo virusne DNK, kar ima za posledico prekinitev verige.
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street,
Slovenian: Glaxo Operations UK Ltd, (trži Glaxo Wellcome Operations), Priory Street,
English: The choice of this fixed combination should be based not only on potential adherence criteria, but mainly on expected efficacy and risk related to the three nucleoside analogues.
Slovenian: Izbira te fiksne kombinacije ne sme temeljiti le na rutini, ampak predvsem na pričakovani učinkovitosti in tveganjih,
English: The usual dose of Trizivir for adults is one tablet twice a day.
Slovenian: Običajni odmerek pri odraslih je ena tableta dvakrat dnevno.
English: In this study, addition of ABC to ZDV/3TC/EFV did not significantly improve efficacy.
Slovenian: V tej študiji dodatek ABC k shemi ZDV/3TC/EFV ni pomembneje izboljšal učinkovitosti.
English: Talk to your doctor before you start taking it again.
Slovenian: Posvetujte se z zdravnikom, preden ga začnete jemati znova.
English: The recommended dose of Trizivir in adults (18 years and over) is one tablet twice daily.
Slovenian: Priporočeni odmerek zdravila Trizivir za odrasle (stare 18 let in več) je ena tableta dvakrat dnevno.
English: Abacavir can cause a serious allergic reaction known as a hypersensitivity reaction.
Slovenian: Abakavir lahko povzroči resno alergijsko reakcijo znano kot preobčutljivostna reakcija.
English: The safety and efficacy of Trizivir in adolescents and children has not been established.
Slovenian: Varnost in učinkovitost zdravila Trizivir pri mladostnikih in otrocih nista bili dokazani.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na zdravilne učinkovine ali katerokoli pomožno snov, navedeno v poglavju 6.1.
English: If you are pregnant, if you become pregnant or if you are planning to become pregnant, talk to your doctor about the risks and benefits to you and your baby of taking Trizivir during your pregnancy.
Slovenian: Nosečnost Če ste noseči, če zanosite ali če nameravate zanositi, se takoj posvetujte z zdravnikom o tveganjih in koristih jemanja zdravila Trizivir med nosečnostjo.
English: It is recommended that treatment is started with abacavir, lamivudine, and zidovudine separately for the first 6-8 weeks (see section 4.4).
Slovenian: Priporočljivo je, da se zdravljenje prične z abakavirjem, lamivudinom in zidovudinom kot samostojnimi zdravili, kar naj traja prvih 6 do 8 tednov (glejte poglavje 4.4).
English: See your doctor as soon as possible.
Slovenian: Čim prej obiščite zdravnika.
English: Antivirals for systemic use, antivirals for treatment of HIV infections, combinations.
Slovenian: Antivirusna zdravila za sistemsko uporabo, antivirusna zdravila za zdravljenje HIV, kombinacije.
English: Your doctor may advise you to stop taking Trizivir.
Slovenian: Zdravnik vam bo morda svetoval, da nehate jemati zdravilo Trizivir.
English: Rare: anxiety, depression
Slovenian: Redki: anksioznost, depresija
English: The EU SPC provides detailed information and advice relating to ABC HSR
Slovenian: EU SPC vsebuje podrobne informacije in nasvete v zvezi s preobčutljivostnimi reakcijami na ABC
English: Symptoms usually include fever, plus some of the following:
Slovenian: Simptomi po navadi vključujejo povišano telesno temperaturo in še nekaj od naslednjega:
English: What Trizivir is and what it is used for What you need to know before you take Trizivir How to take Trizivir
Slovenian: Kaj je zdravilo Trizivir in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Trizivir Kako jemati zdravilo Trizivir
English: These changes are not considered clinically relevant and no food restrictions are recommended for administration of Trizivir.
Slovenian: Te spremembe se ne smatrajo kot klinično pomembne, zato pri dajanju zdravila Trizivir ni priporočil o omejitvah pri uživanju hrane.
English: Virologic failure (HIV RNA >200 copies/ml)
Slovenian: Virološki neuspeh (HIV RNA > 200 kopij/ml)
English: In addition, the 69 insertion complex or the Q151M mutation, usually found in combination with A62V, V75I, F77L and F116Y, cause a high level of resistance to abacavir.
Slovenian: Poleg tega je sta insercijski kompleks na mestu 69 ali mutacija Q151M, običajno ugotovljena v kombinaciji z A62V, V75I, F77L in F116Y, povzročila visoko stopnjo odpornosti proti abakavirju.
English: Virologic success (48 weeks HIV RNA < 50 copies/ml)
Slovenian: Virološki uspeh (48 tednov HIV RNA < 50 kopij/ml)
English: Therefore, there is little potential for interactions with antiretroviral protease inhibitors, nonnucleosides and other medicinal products metabolised by major P450 enzymes.
Slovenian: Torej obstaja le majhna možnost za interakcije s protiretrovirusnimi zaviralci proteaz, z nenukleozidi in drugimi zdravili, ki se presnavljajo z glavnimi encimi iz skupine P450.
English: If you are hypersensitive to Trizivir, return all your unused Trizivir tablets for safe disposal.
Slovenian: Če ste preobčutljivi na zdravilo Trizivir, vse neporabljene tablete zdravila Trizivir vrnite, da jih bodo varno uničili.
English: There are no data on the use of Trizivir in pregnancy.
Slovenian: Podatkov o uporabi zdravila Trizivir med nosečnostjo ni.
English: Currently there are no data on the use of Trizivir in heavily pre-treated patients, patients failing on other therapies or patients with advanced disease (CD4 cells < 50 cells/mm3).
Slovenian: Trenutno ni podatkov o uporabnosti zdravila Trizivir pri bolnikih, ki so bili predhodno intenzivno zdravljeni, pri bolnikih pri katerih so bila druga zdravljenja neuspešna, ali pri bolnikih z napredovalo boleznijo (CD4 celice < 50 celic/mm3).
English: A modest increase in Cmax (28 %) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) was not significantly altered.
Slovenian: Opazili so zmeren porast Cmax (28 %) zidovudina, če so ga dajali skupaj z lamivudinom, vendar se celotna izpostavljenost (AUC) ni signifikantno spremenila.
English: • chest pain; disease of the heart muscle (cardiomyopathy)
Slovenian: • bolečine v prsih; bolezen srčne mišice (kardiomiopatija),
English: Signs of osteonecrosis include:
Slovenian: Med znaki osteonekroze so:
English: When prescribing Trizivir, action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Slovenian: Ko predpisujete zdravilo Trizivir, poizkusite zmanjšati vse prilagodljive dejavnike tveganja (npr. kajenje, hipertenzijo in hiperlipidemijo).
English: • Additional risk minimisation measures
Slovenian: • Dodatni ukrepi za zmanjšanje tveganj
English: Zidovudine has no effect on the pharmacokinetics of lamivudine.
Slovenian: Zidovudin ne vpliva na farmakokinetične lastnosti lamivudina.
English: With this condition, parts of the bone tissue die because of reduced blood supply to the bone.
Slovenian: Pri tej motnji deli kostnega tkiva odmrejo zaradi zmanjšane oskrbe kosti s krvjo.
English: Appropriate use of abacavir can be guided using currently recommended resistance algorithms.
Slovenian: Za ustrezno uporabo abakavirja je potrebno upoštevati trenutno veljavne algoritme odpornosti.
English: You may need extra check-ups, including blood tests, while you are taking your medicine.
Slovenian: Morda boste med jemanjem tega zdravila potrebovali dodatne kontrole, vključno s preiskavami krvi.
English: • In order to avoid restarting abacavir patients who have experienced a suspected HSR should be instructed to dispose of their remaining Trizivir tablets
Slovenian: • Da bi preprečili ponovno uporabo abakavirja, je treba bolnikom, ki so imeli sum na HSR, naročiti, naj preostale tablete zdravila Trizivir zavržejo.
English: INFORMATION IN BRAILLE trizivir
Slovenian: PODATKI V BRAILLOVI PISAVI trizivir
English: Patients with end-stage renal disease.
Slovenian: Bolniki s terminalnim stadijem ledvične bolezni.
English: • difficulty moving
Slovenian: • težave pri gibanju.
English: Swallow the tablets whole, with some water.
Slovenian: Tablete pogoltnite cele z vodo.
English: • enlarged breasts in men
Slovenian: • povečanje prsi pri moških.
English: • other medicinal products containing lamivudine, used to treat HIV infection or hepatitis B
Slovenian: • drugih zdravil, ki vsebujejo lamivudin, ki se uporablja za zdravljenje okužbe s HIV ali okužbe s hepatitisom B,
English: Lamivudine was not teratogenic in animal studies but there were indications of an increase in early embryonic deaths in the rabbit at relatively low systemic exposures, comparable to those achieved in humans.
Slovenian: V raziskavah na živalih lamivudin ni pokazal teratogenih učinkov, obstajajo pa indikacije za povečano embrionalno smrtnost kuncev in to že pri relativno nizkih sistemskih izpostavljenostih, ki so primerljive doseženim pri ljudeh.
English: Risk of heart attack
Slovenian: Tveganje srčnega infarkta
English: Abacavir has a weak potential to cause chromosomal damage both in vitro and in vivo at high test concentrations and therefore any potential risk to man must be balanced against the expected benefits of treatment.
Slovenian: Abakavir ima šibek potencial, da pri visokih testnih koncentracijah tako in vitro kot in vivo povzroča poškodbo kromosomov, zato je potrebno pretehtati med kakršnim koli možnim tveganjem pri človeku in pričakovanimi koristi zdravljenja.
English: When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation.
Slovenian: Ko ti bolniki začnejo zdravljenje, lahko pride do zagona starih, prikritih okužb, ki povzroči znake ali simptome vnetja.
English: Hypersensitivity reactions can start at any time during treatment with Trizivir, but are more likely during the first 6 weeks of treatment.
Slovenian: Preobčutljivostne reakcije se lahko začnejo kadarkoli med zdravljenjem z zdravilom Trizivir, vendar so verjetnejše v prvih 6 tednih zdravljenja.
English: Based on data obtained for abacavir, Trizivir is not recommended in patients with moderate or severe hepatic impairment.
Slovenian: Na podlagi podatkov pridobljenih za abakavir se zdravilo Trizivir ne priporoča pri bolnikih, ki imajo zmerno ali hudo jetrno okvaro.
English: It is concluded that as the increase in incidence of tumours in the first transplacental carcinogenicity study represents a hypothetical risk, this should be balanced against the proven therapeutic benefit.
Slovenian: Sklepajo, da predstavlja povečanje pojavnosti tumorjev v prvi raziskavi o transplacentalni karcinogenosti hipotetično tveganje, ki ga je potrebno pretehtati v razmerju do dokazane terapevtske koristi.
English: What you need to know before you take Trizivir
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Trizivir
English: Exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated.
Slovenian: Opisano je bilo poslabšanje anemije zaradi ribavirina, če je bil zidovudin del sheme za zdravljenje HIV, čeprav natančni mehanizem tega ni razjasnjen.
English: • lactic acidosis (excess lactic acid in the blood ; see the next section, ‘Other possible side effects of
Slovenian: • laktacidoza (čezmerno kopičenje mlečne kisline v krvi; glejte naslednje poglavje, "Drugi možni neželeni učinki zdravila Trizivir"),
English: When these signs occur, Trizivir should be stopped and your HIV treatment changed.
Slovenian: Ko se pojavijo ti znaki, je treba zdravljenje z zdravilom Trizivir prekiniti in spremeniti zdravljenje okužbe z virusom HIV.
English: Do not take Trizivir:
Slovenian: Ne jemljite zdravila Trizivir:
English: In patients with high viral load (> 100,000 copies/ml) choice of therapy needs special consideration (see section 5.1).
Slovenian: Pri bolnikih z visoko virusno obremenitvijo (> 100.000 kopij/ml) je potreben še posebej skrben premislek pred izbiro zdravljenja (glejte poglavje 5.1).
English: Following multiple oral doses of abacavir 300 mg twice a day there is no significant accumulation of abacavir.
Slovenian: Po večkratnih peroralnih odmerkih po 300 mg dvakrat dnevno ne prihaja do pomembnega kopičenja abakavirja.
English: K65R was absent and L74V and Y115F were uncommon (≤3 %).
Slovenian: K65R ni bila prisotna, L74V in Y115F pa sta bili občasni (≤ 3 %).
English: It is recommended that mothers infected by HIV do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Slovenian: Priporočljivo, da matere, ki so okužene z virusom HIV, v nobenem primeru ne dojijo in se tako izognejo možnosti za prenos virusa HIV na otroka.
English: Abacavir + Combivir
Slovenian: Abakavir + Combivir
English: Key elements included in the educational material to increase understanding and awareness of ABC HSR and expand on the information already included in the currently approved EU SPC:
Slovenian: Ključni elementi, vključeni v izobraževalno gradivo za povečanje razumevanja in ozaveščenosti o preobčutljivostnih reakcijah na ABC in razširitev informacij, ki so že vključene v trenutno odobreni