FrancophonIA/ELRC3.0 huggingface dataset:
English: Cushingoid
Slovenian: cushingoidni sindrom cushingoidni sindrom
English: MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration
Slovenian: Izmišljeno ime Jakost Farmacevtska oblika Pot uporabe
English: You may need to read it again.
Slovenian: Morda ju boste želeli ponovno prebrati.
English: and 5.2).
Slovenian: in 5.2).
English: • Risk Management Plan (RMP)
Slovenian: • Načrt za obvladovanje tveganja (RMP)
English: They may be taken with or without food.
Slovenian: Lahko se jemljejo s hrano ali brez nje.
English: No data are available
Slovenian: Podatki niso na voljo.
English: After 2−4 weeks, your doctor may increase the dose to get the right effect.
Slovenian: Po 2−4 tednih vam zdravnik lahko poveča odmerek, da doseže pravi učinek.
English: Germany or
Slovenian: Nemčija ali
English: No similar changes have been identified in humans.
Slovenian: Podobnih sprememb pri človeku niso ugotovili.
English: If you forget to take a dose, take it as soon as you remember unless it is nearly time (less than 6 hours) to take your next dose.
Slovenian: Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite, razen če je skoraj čas (manj kot 6 ur), ko bi morali vzeti naslednji odmerek.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09 July 2008
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 9. julij 2008
English: A risk to the suckling child cannot be excluded.
Slovenian: Ne moremo izključiti tveganja za doječega otroka.
English: Always swallow the tablets whole with water.
Slovenian: Tablete vedno pogoltnite cele z vodo.
English: If you experience these symptoms, do not drive or operate machinery until they have resolved completely.
Slovenian: Če imate takšne simptome, ne vozite in ne upravljajte strojev, dokler ti simptomi popolnoma ne izginejo.
English: Date of last renewal: 06 March 2013
Slovenian: Datum zadnjega podaljšanja: 6. marec.
English: These medicines may cause muscle pain and muscle injury.
Slovenian: Ta zdravila lahko povzročijo bolečine v mišicah in poškodbe mišic.
English: Do not throw away any medicines via wastewater or household waste.
Slovenian: Zdravil ne smete odvreči v odpadne vode ali gospodinjske odpadke.
English: If you cannot contact your doctor, go to the nearest accident and emergency department.
Slovenian: Če ne morete obvestiti svojega zdravnika, pojdite v najbližji oddelek za nujno pomoč.
English: Additionally, 45% of the study population also received long-acting nitrates.
Slovenian: Poleg tega je 45% populacije, ki je sodelovala v študiji, prejemalo tudi dolgo delujoče nitrate.
English: 24041 Brembate (BG) Italy or
Slovenian: 24041 Brembate (BG) Italija ali
English: Rare: disorientation.
Slovenian: Redki: dezorientiranost.
English: QT prolongation was more pronounced in these patients.
Slovenian: Podaljšanje intervala QT je bilo pri teh bolnikih izrazitejše.
English: In the event of overdose, the patient should be closely monitored and the treatment should be symptomatic and supportive.
Slovenian: Pri prevelikem odmerjanju je treba bolnika pozorno nadzorovati, zdravljenje pa je simptomatsko in podporno.
English: • swollen face, tongue, or throat
Slovenian: • otekanje obraza, jezika ali grla;
English: These effects do not depend upon changes in heart rate, blood pressure, or vasodilation.
Slovenian: Ti učinki niso odvisni od sprememb hitrosti srčnega utripa, krvnega tlaka ali vazodilatacije.
English: Less than 5% of the dose is excreted unchanged in the urine and faeces.
Slovenian: Manj kot 5% odmerka se izloči v nespremenjeni obliki z urinom ali blatom.
English: Mechanism of action: The mechanism of action of ranolazine is largely unknown.
Slovenian: Mehanizem delovanja: mehanizem delovanja ranolazina je večinoma neznan.
English: Other side effects you may experience include the following:
Slovenian: Med drugimi neželenimi učinki, ki se lahko pojavijo, so:
English: Fourteen primary pathways have been identified of which O-demethylation and N-dealkylation are the most important.
Slovenian: Odkrili so 14 primarnih presnovnih poti, med katerimi sta najpomembnejši O-demetilacija in N-dealkilacija.
English: Tissue distribution of drugs which are transported by P-gp may be increased.
Slovenian: Tkivna distribucija zdravil, ki jih prenaša P-gp, se lahko poveča.
English: In patients with a combination of these factors, additional exposure increases are expected.
Slovenian: Pri bolnikih, pri katerih je prisotna kombinacija teh dejavnikov, se lahko pričakuje dodatna izpostavljenost.
English: • hives or difficulty breathing
Slovenian: • koprivnica ali težave pri dihanju.
English: Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: Use in children and adolescents Children and adolescents under 18 years old should not take Ranexa.
Slovenian: Uporaba pri otrocih in mladostnikih Otroci in mladostniki, mlajši od 18, let ne smejo jemati zdravila Ranexa.
English: The safety and efficacy of Ranexa in children below the age of 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Ranexa pri otrocih, mlajših od 18 let nista bili dokazani.
English: If symptoms do not resolve after dose reduction, treatment should be discontinued.
Slovenian: Če po zmanjšanju odmerka simptomi ne izginejo, je treba zdravljenje prekiniti.
English: Do not crush, suck, or chew the tablets or break them in half, as this might affect the way the medicine is released from the tablets into your body.
Slovenian: Tablet ne drobite, sesajte, žvečite ali prelamljajte, saj to lahko vpliva na način sproščanja zdravila iz tablet v telo.
English: SpA Via R. Follereau 25 24027 Nembro (BG) Italy
Slovenian: SpA Via R. Follereau 25 24027 Nembro (BG) Italija
English: This effect is associated with increased plasma cholesterol concentrations.
Slovenian: Ta učinek je povezan s povečanimi koncentracijami holesterola v plazmi.
English: Lactose: This medicinal product contains lactose.
Slovenian: Laktoza: To zdravilo vsebuje laktozo.
English: Depending on the tablet strength, the tablet coatings also contain:
Slovenian: Glede na jakost tablete obloga tablete vsebuje tudi:
English: Ranexa tablets should be swallowed whole and not crushed, broken, or chewed.
Slovenian: Tablete Ranexa je treba pogoltniti cele, ne sme se jih zdrobiti, prepoloviti ali žvečiti.
English: The adverse events, considered to be at least possibly related to treatment, are listed below by body system, organ class, and absolute frequency.
Slovenian: Neželeni dogodki, za katere menijo, da so vsaj morda povezani z zdravljenjem, so navedeni spodaj, po organskih sistemih in absolutni pogostnosti.
English: This colouring agent- may cause allergic reactions.
Slovenian: To barvilo lahko povzroči alergijske reakcije.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo predložiti so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Food does not affect the rate and extent of absorption of ranolazine.
Slovenian: Hrana ne vpliva na hitrost in obseg absorpcije ranolazina.
English: Undesirable effects in patients receiving Ranexa are generally mild to moderate in severity and often develop within the first 2 weeks of treatment.
Slovenian: Neželeni učinki pri bolnikih, ki prejemajo zdravilo Ranexa, so na splošno blagi do zmerni in se pogosto pojavijo v prvih dveh tednih zdravljenja.
English: The adverse event profile was generally similar in the MERLIN-TIMI 36 study.
Slovenian: Profil neželenih dogodkov je bil v študiji MERLIN-TIMI 36 podoben.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujete s svojim zdravnikom, preden vzamete to zdravilo.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and very rare (< 1/10,000).
Slovenian: Po pogostnosti so opredeljeni kot zelo pogosti ( 1/10), pogosti (od  1/100 do  1/10), občasni (od  1/1000 do < 1/100), redki (od  1/10.000 do < 1/1000) in zelo redki (< 1/10.000).
English: The exposure of other OCT2 substrates, including but not limited to pindolol and varenicline, may be affected to a similar degree.
Slovenian: Učinek na izpostavljenost drugih OCT2 substratov, vključno vendar ne omejeno s pindololom in vareniklinom, je lahko na podobni stopnji.
English: Pregnancy: There are limited amount of data from the use of ranolazine in pregnant women.
Slovenian: Nosečnost: Na voljo so omejeni podatki o uporabi ranolazina pri nosečnicah.
English: The potential for inhibition of CYP2B6 has not been evaluated.
Slovenian: Potenciala za zaviranje encima CYP2B6 niso ovrednotili.
English: What Ranexa is and what it is used for 2.
Slovenian: Kaj je zdravilo Ranexa in za kaj ga uporabljamo 2.
English: Ranolazine is a substrate for P-gp.
Slovenian: Ranolazin je substrat P-gp.
English: The mean steady-state volume of distribution (Vss) is about 180 l.
Slovenian: Povprečni volumen porazdelitve v stanju dinamičnega ravnovesja (Vss) je približno 180 l.
English: Take along any tablets that are left, including the container and the carton, so that the hospital staff can easily tell what you have taken.
Slovenian: S seboj vzemite preostale tablete, vsebnik in škatlo, da bo osebje v bolnišnici vedelo, kaj ste vzeli.
English: There are no data in patients with severe hepatic impairment.
Slovenian: Za bolnike s hudo jetrno okvaro ni podatkov.
English: In this study, exercise duration was longest in the 1500 mg group; however, there was a disproportional increase in side effects, and the 1500 mg dose was not studied further.
Slovenian: V tej študiji je bil čas telesne vadbe najdaljši v skupini, ki je prejemala 1500 mg, vendar so opazili tudi nesorazmerno povečanje neželenih učinkov, zato odmerka 1500 mg niso nadalje raziskovali.
English: Approximately one-half of the patients in MERLIN-TIMI 36 had a history of angina.
Slovenian: Približno polovica bolnikov v študiji MERLIN-TIMI 36 je imela angino v anamnezi.
English: Approximately 62% of ranolazine is bound to plasma proteins, and therefore, complete clearance by haemodialysis is unlikely.
Slovenian: Približno 62% ranolazina je vezanega na beljakovine v plazmi, zato popolna odstranitev s hemodializo ni verjetna.
English: The influence of various factors on the pharmacokinetics of ranolazine was assessed in a population pharmacokinetic evaluation in 928 angina patients and healthy subjects.
Slovenian: Vpliv različnih dejavnikov na farmakokinetiko ranolazina so ocenili v populacijski raziskavi farmakokinetike na 928 bolnikih z angino in zdravih osebah.
English: Gender effects: Gender had no clinically relevant effect on pharmacokinetic parameters.
Slovenian: Učinki spola: Spol ni imel klinično pomembnega učinka na farmakokinetične parametre.
English: Both the average number of angina attacks and nitroglycerin tablets consumed decreased by approximately one per week.
Slovenian: Povprečno število napadov angine in porabljenih tablet nitroglicerina se je zmanjšalo za približno ena na teden.
English: The Seattle Angina Questionnaire showed significant effects on several dimensions, including angina frequency (p < 0.001), compared to placebo-treated patients.
Slovenian: Vprašalnik o angini Seattle je pokazal pomembne učinke na več razsežnosti, vključno s pogostnostjo angine (p < 0,001), v primerjavi z bolniki, ki so jih zdravili s placebom.
English: What you need to know before you take Ranexa 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Ranexa 3.
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 http://www.ema.europa.eu.
English: Azo colouring agent E102: This medicinal product contains the azo colouring agent E102 which may cause allergic reactions.
Slovenian: Barvilo azo E102: To zdravilo vsebuje barvilo azo E102, ki lahko povzroči alergijske reakcije.
English: Steady state is generally achieved within 3 days of twice-daily dosing.
Slovenian: Stanje dinamičnega ravnovesja je ponavadi doseženo po 3 dneh odmerjanja dvakrat na dan.
English: Paediatric population: The pharmacokinetic parameters of ranolazine have not been studied in the paediatric population (< 18 years).
Slovenian: Pediatrična populacija: Farmakokinetičnih parametrov ranolazina pri pediatričnih bolnikih (< 18 let) niso raziskovali.
English: No effect on the adreno-cortical axis was noted in humans.
Slovenian: Učinka na adrenokortikalno os pri človeku niso opazili.
English: Pharmacotherapeutic group: Other cardiac preparations, ATC code: C01EB18
Slovenian: Farmakoterapevtska skupina: Druga zdravila za bolezni srca, oznaka ATC: C01EB18
English: Elderly patients: Age alone had no clinically relevant effect on pharmacokinetic parameters.
Slovenian: Starejši bolniki: Sama starost ni imela klinično pomembnega učinka na farmakokinetične parametre.
English: 6.6 Special precautions for disposal No special requirements
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje Ni posebnih zahtev.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Slovenian: Za vse morebitne nadaljne informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: There is a theoretical risk that concomitant treatment of ranolazine with other drugs known to prolong the QTc interval may give rise to a pharmacodynamic interaction and increase the possible risk of ventricular arrhythmias.
Slovenian: Obstaja teoretično tveganje, da lahko sočasna uporaba ranolazina in drugih zdravil, za katere je znano, da podaljšajo interval QTc, poveča farmakodinamične interakcije in poveča morebitno tveganje za ventrikularne aritmije.
English: Elderly, renal impairment, and low weight: In general, adverse events occurred more frequently among elderly patients and patients with renal impairment; however, the types of events in these subgroups were similar to those observed in the general population.
Slovenian: Starejši bolniki, bolniki z ledvično okvaro in bolniki z majhno telesno maso: Na splošno so bili neželeni dogodki pogostejši pri starejših bolnikih in bolnikih z ledvično okvaro, vendar so vrste dogodkov v teh podskupinah bile podobne tistim, ki so jih opazili pri splošni populaciji.
English: Caution should be exercised when prescribing or uptitrating ranolazine to patients in whom an increased exposure is expected:
Slovenian: Pri predpisovanju ali povečevanju odmerka ranolazina bolnikom, pri katerih se pričakuje povečana izpostavljenost, je potrebna previdnost:
English: Excipients: Each tablet contains 0.04 mg azo colouring agent E102 and 12.0 mg lactose monohydrate.
Slovenian: Pomožne snovi: tableta vsebuje 0,04 mg azo barvilo E102 in 12,0 mg laktozo monohidrat.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Izdaja zdravila je le na recept.
English: No dose adjustment is required.
Slovenian: Prilagajanje odmerkov ni potrebno.
English: In long-term carcinogenicity studies at doses of ranolazine up to 50 mg/kg/day (150 mg/m 2/day) in mice and 150 mg/kg/day (900 mg/m2/day) in rats, no relevant increases in the incidence of any tumour types were seen.
Slovenian: V dolgotrajnih študijah kancerogenosti pri odmerkih ranolazina do 50 mg/kg/dan (150 mg/m2/dan) pri miših in 150 mg/kg/dan (900 mg/m2/dan) pri podganah niso opazili pomembnih povečanj pojavnosti nobene vrste tumorjev.
English: If you forget to take Ranexa
Slovenian: Če ste pozabili vzeti zdravilo Ranexa
English: Distribution: Approximately 62% of ranolazine is bound to plasma proteins, mainly alpha-1 acid glycoprotein and weakly to albumin.
Slovenian: Porazdelitev: Približno 62% ranolazina je vezanega na beljakovine v plazmi, predvsem na alfa-1 kisli glikoprotein in šibko na albumin.
English: However, there was no difference in exercise duration between the two doses (24 seconds compared to placebo; p ≤ 0.03).
Slovenian: Vendar med odmerkoma ni bilo razlik v trajanju telesne vadbe (24 sekund v primerjavi s placebom; p  0,003).
English: Clinical efficacy and safety: Clinical studies have demonstrated the efficacy and safety of Ranexa in the treatment of patients with chronic angina, either alone or when the benefit from other antianginal medicinal products was sub-optimal.
Slovenian: Klinična učinkovitost in varnost: Klinične študije so pokazale učinkovitost in varnost zdravila Ranexa pri zdravljenju bolnikov s kronično angino, bodisi kadar se uporablja samo bodisi v kombinaciji z drugimi antianginoznimi zdravili, kadar je njihova učinkovitost suboptimalna.
English: Studies in animals showed embryo toxicity (see Section 5.3).
Slovenian: Študije na živalih so pokazale embriotoksičnost (glejte poglavje 5.3).
English: Do not use this medicine after the expiry date which is stated on each blister strip of tablets and on the outside of the carton and bottle after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vseh pretisnih omotih ter na zunanjosti škatle in steklenice za oznako Uporabno do.
English: Pregnancy You should not take Ranexa if you are pregnant unless your doctor has advised you to do so.
Slovenian: Nosečnost Zdravila Ranexa ne smete jemati, če ste noseči, razen če vam je zdravnik tako naročil.
English: In a second study, ERICA, Ranexa was added to treatment with amlodipine 10 mg once daily (the maximum labelled dose).
Slovenian: V drugi študiji, ERICA, so zdravilo Ranexa dodali zdravljenju z amlodipinom v odmerku 10 mg enkrat na dan (največji dovoljeni odmerek).
English: In this long term study, acute renal failure was also reported with an incidence less than 1% in placebo and ranolazine patients.
Slovenian: Tudi v tej dolgoročni raziskavi so poročali o akutni odpovedi ledvic, pogostost je bila manj kot 1% pri bolnikih ki so jemali placebo in ranolazin.
English: If Ranexa is used in patients with a combination of several of these factors, monitoring of adverse events should be frequent, the dose reduced, and treatment discontinued, if needed.
Slovenian: Če zdravilo Ranexa jemljejo bolniki, pri katerih je prisotna kombinacija več teh dejavnikov, je treba pri njih redno spremljati neželene učinke, zmanjšati odmerek in po potrebi prekiniti zdravljenje.
English: While being treated with Ranexa, you should not drink grapefruit juice.
Slovenian: Med zdravljenjem z zdravilom Ranexa ne smete piti soka grenivke.
English: PHARMACEUTICAL FORM AND CONTENTS 30 prolonged-release tablets 60 prolonged-release tablets 100 prolonged-release tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 30 tablet s podaljšanim sproščanjem 60 tablet s podaljšanim sproščanjem 100 tablet s podaljšanim sproščanjem
English: Dosedependent side effects are likely to occur.
Slovenian: Verjetno se bodo pojavili od odmerka odvisni neželeni učinki .
English: Ranexa should not be used during pregnancy unless clearly necessary.
Slovenian: Zdravila Ranexa ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
English: Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany or
Slovenian: Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Nemčija ali
English: Tolerance to ranolazine did not develop during treatment and a rebound increase in angina attacks was not observed following abrupt discontinuation.
Slovenian: Med zdravljenjem se ni razvila toleranca za ranolazin, po nenadni prekinitvi zdravljenja pa niso opazili povratnega povečanja števila napadov angine.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali z malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Breast-feeding: It is unknown whether ranolazine is excreted in human breast milk.
Slovenian: Dojenje: Ni znano, ali se ranolazin izloča v materino mleko pri človeku.
English: These were reported during the Phase 3 clinical development programme, which included a total of 1,030 chronic angina patients treated with Ranexa.
Slovenian: O naslednjih neželenih učinkih so poročali v programu kliničnega razvoja III. faze, v katerem je sodelovalo skupno 1030 bolnikov s kronično angino, ki so prejemali zdravilo Ranexa.
English: A renal function study in healthy volunteers demonstrated a reduction in creatinine clearance with no change in glomerular filtration rate consistent with inhibition of renal tubular secretion of creatinine.
Slovenian: Študija delovanja ledvic pri zdravih prostovoljcih je pokazala zmanjšanje kreatininskega očistka brez spremembe v hitrosti glomerularne filtracije, vendar povezano z zaviranjem tubularne sekrecije kreatinina.
English: The effect of ranolazine on human fertility is unknown.
Slovenian: Učinek ranolazina na plodnost pri človeku ni znan.
English: In the main dose-finding study, MARISA, ranolazine was used as monotherapy.
Slovenian: Pri glavni študiji za določanje odmerka, MARISA, so ranolazin uporabljali kot samostojno zdravljenje.
English: After 2-4 weeks, the dose should be titrated to 500 mg twice daily and, according to the patient's response, further titrated to a recommended maximum dose of 750 mg twice daily (see section 5.1).
Slovenian: Po 2-4 tednih je treba odmerek titrirati na 500 mg dvakrat na dan in potem, glede na bolnikov odziv, do priporočenega največjega odmerka 750 mg dvakrat na dan, (glejte poglavje 5.1).
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: Navodilo za uporabo zdravila mora vsebovati ime in naslov izdelovalca zdravila, odgovornega za sproščanje serij zdravila
English: Body weight: Compared to subjects weighing 70 kg, exposure was estimated to be about 1.4-fold higher in subjects weighing 40 kg.
Slovenian: Telesna masa: V primerjavi z osebami, ki so imele telesno maso 70 kg, so ocenili, da je izpostavljenost pri osebah s telesno maso 40 kg, približno 1,4-krat večja.
English: Reproductive system and breast disorders Rare: erectile dysfunction.
Slovenian: Motnje reprodukcije in dojk Redki: erektilna disfunkcija.
English: Evaluations in patients who may be considered at higher risk of adverse events when treated with other antianginal medicinal products, e.g. patients with diabetes, Class I and II heart failure, or obstructive airway disease, confirmed that these conditions were not associated with clinically meaningful increases in the incidence of adverse events.
Slovenian: Vrednotenje bolnikov, ki imajo večje tveganje za nastanek neželenih dogodkov, kadar prejemajo druga zdravila za zdravljenje angine pektoris, npr. bolnikov z diabetesom, srčnim popuščanjem razreda I in II ali obstruktivno boleznijo dihal, je pokazala, da te bolezni niso povezane s klinično pomembnim povečanjem pogostnosti neželenih dogodkov.