natgillin/translations-raw huggingface dataset:
Proportion of FVC responders at 52 weeks in trials INPULSIS-1, INPULSIS-2 and their pooled data - treated set
Preglednica 3: Delež odzivnih FVC pri 52. tednih v preskušanjih INPULSIS-1, INPULSIS-2 in združeni podatki - zdravljeni bolniki
Renal function
Delovanje ledvic
INPULSIS-1 and INPULSIS-2 pooled
INPULSIS-1 in INPULSIS-2 združeno
Supportive evidence from the phase II trial (1199.30) Ofev 150 mg twice daily results Additional evidence of efficacy is provided by the randomised, double-blind, placebo-controlled, dose finding phase II trial including a nintedanib 150 mg twice daily dose group.
Dodatne dokaze o učinkovitosti so pridobili z randomiziranim, dvojno slepim, s placebom nadzorovanim preskušanjem za ugotavljanje odmerka faze II, ki je vključevalo skupino, ki je prejemala nintedanib po 150 mg dvakrat na dan.
Based on the mechanism of action nintedanib may impair wound healing.
Zaradi mehanizma delovanja lahko nintedanib poslabša celjenje ran.
The contribution of renal excretion to the total clearance was low (0.649% of dose, 26.3% gCV).
(0,649 % odmerka, 26,3 % gCV).
Nausea and vomiting were frequently reported gastrointestinal adverse reactions (see section 4.8).
Pogosta neželena učinka prebavil sta bila navzea in bruhanje (glejte poglavje 4.8).
Ofev may have minor influence on your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Ofev ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
All-cause mortality over 52 weeks in trials INPULSIS-1, INPULSIS-2, and their pooled data - treated set
Preglednica 6: Smrtnost zaradi vseh razlogov v 52. tednih v preskušanjih INPULSIS-1, INPULSIS-2 in združeni podatki - zdravljeni bolniki
6.1 List of excipients
6.1 Seznam pomožnih snovi
Hepatic impairment
Bolezni živčevja glavobol
The treatment may be resumed at a reduced dose (100 mg twice daily) or at the full dose (150 mg twice daily).
Zdravljenje se lahko nadaljuje z zmanjšanim odmerkom (100 mg dvakrat na dan) ali s polnim odmerkom (150 mg dvakrat na dan).
Do not take two capsules together if you have forgotten to take your earlier dose.You should take your next 150 mg dose of Ofev as planned at the next scheduled time recommended by your doctor or pharmacist.
Naslednji 150 mg odmerek zdravila Ofev vzemite ob naslednjem načrtovanem času, ki ga priporoča zdravnik ali farmacevt.
The safety and efficacy of nintedanib have not been investigated in patients with hepatic impairment classified as Child Pugh B and C. Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with Ofev is not recommended (see section 5.2).
Zdravljenja bolnikov z zmerno (Child Pugh B) in hudo (Child Pugh C) jetrno okvaro z zdravilom Ofev ne priporoča (glejte poglavje 5.2).
Ofev 150 mg soft capsules nintedanib
Ofev 150 mg mehke kapsule nintedanib
Ofev 100 mg soft capsules nintedanib
Ofev 100 mg mehke kapsule nintedanib
Each capsule contains 100 mg nintedanib (as esilate).
Ena kapsula vsebuje 100 mg nintedaniba (v obliki esilata).
Ofev treatment may be resumed at the full dose (150 mg twice daily) or a reduced dose (100 mg twice daily).
Zdravljenje z zdravilom Ofev lahko nadaljujete s polnim odmerkom (150 mg dvakrat na dan) ali z zmanjšanim odmerkom (100 mg dvakrat na dan).
The event was reported to be of severe intensity in 3.3% of nintedanib treated patients.
Pri 3,3 % bolnikov zdravljenih z nintedanibom so poročali, da je bil dogodek resen.
The likelihood of drug-drug interactions with nintedanib based on CYP metabolism is therefore considered to be low.
Na podlagi presnove s CYP velja, da je verjetnost medsebojnega delovanja zdravil z nintedanibom majhna.
Nintedanib follows at least bi-phasic disposition kinetics.
Nintedanib se porazdeli v najmanj dveh fazah.
Each capsule contains 150 mg nintedanib (as esilate).
Ena kapsula vsebuje 150 mg nintedaniba (v obliki esilata).
Headache
Driska
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
(glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Odds ratio
Razmerje tveganja
Reproduction toxicity
Vpliv na sposobnost razmnoževanja
NAME OF THE MEDICINAL PRODUCT Ofev 100 mg capsules nintedanib
IME ZDRAVILA Ofev 100 mg kapsule nintedanib
NAME OF THE MEDICINAL PRODUCT Ofev 150 mg capsules nintedanib
IME ZDRAVILA Ofev 150 mg kapsule nintedanib
Hepatic enzyme increased
Zvečanje vrednosti jetrnih encimov
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 100 mg nintedanib (as esilate).
NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 100 mg nintedaniba (v obliki esilata).
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 150 mg nintedanib (as esilate).
NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 150 mg nintedaniba (v obliki esilata).
Ofev 150 mg capsules are brown-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure “150”.
Zdravilo Ofev 150 mg mehke kapsule so neprozorne in podolgovate želatinske kapsule rjave barve, ki imajo na eni strani črno natisnjeno oznako podjetja Boehringer Ingelheim in številko “150”.
NAME OF THE MEDICINAL PRODUCT Ofev 100 mg soft capsules nintedanib
IME ZDRAVILA Ofev 100 mg mehke kapsule nintedanib
NAME OF THE MEDICINAL PRODUCT Ofev 150 mg soft capsules nintedanib
IME ZDRAVILA Ofev 150 mg mehke kapsule nintedanib
One soft capsule contains 100 mg nintedanib (as esilate) Excipient with known effect
Ena mehka kapsula vsebuje 100 mg nintedaniba (v obliki esilata).
Ofev 100 mg capsules are peach-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure “100”.
Zdravilo Ofev 100 mg mehke kapsule so neprozorne in podolgovate želatinske kapsule v barvi breskve, ki imajo na eni strani črno natisnjeno oznako podjetja Boehringer Ingelheim in številko “100”.
One soft capsule contains 150 mg nintedanib (as esilate) Excipient with known effect
Ena mehka kapsula vsebuje 150 mg nintedaniba (v obliki esilata).
Marketing Authorisation Holder
Imetnik dovoljenja za promet z zdravilom
Vomiting
Krvavitev
DATE OF REVISION OF THE TEXT
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Tabulated list of adverse reactions
Seznam neželenih učinkov
What Ofev contains - The active substance is nintedanib.
- Učinkovina je nintedanib.
Haemorrhage
Predrtje prebavil
Common
Pogosti
Hepatic function
Delovanje jeter
- The other ingredients are:
Pogostnosti kategorij so opredeljene po naslednjem dogovoru:
This summary was last updated in 08-2013.
Povzetek je bil nazadnje posodobljen 08-2013.
It can be used in patients with the following forms of the disease:
Uporablja se lahko pri bolnikih z naslednjimi oblikami bolezni:
What measures are being taken to ensure the safe and effective use of Pheburane?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pheburane?
The full EPAR for Pheburane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pheburane je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Pheburane on 31 July 2013.
Evropska komisija je dovoljenje za promet z zdravilom Pheburane, veljavno po vsej Evropski uniji, odobrila dne 31. julija 2013.
Regular blood tests are needed to find the correct daily dose.
Da se določi pravilni dnevni odmerek, so potrebne redne preiskave krvi.
Pheburane is available as granules (483 mg/g).
Zdravilo Pheburane je na voljo v obliki zrnc (483 mg/g).
• 'early-onset' disease in patients who show a complete lack of one or more of these enzymes within the first month of life;
• pri zgodnji bolezni pri bolnikih, ki izkazujejo popolno pomanjkanje enega ali več teh encimov v prvem mesecu življenja;
The granules can be sprinkled onto food immediately before being swallowed or placed in the mouth and swallowed immediately with a drink.
Zrnca se lahko tik pred zaužitjem nasuje na hrano ali da v usta in takoj pogoltne s tekočino.
This means that it is similar to a ‘reference medicine' containing the same active substance, but Pheburane granules are available at a lower strength and contain different excipients (inactive ingredients) to mask the unpleasant taste of the active substance.
To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje enako zdravilno učinkovino, vendar so zrnca zdravila Pheburane na voljo v nižji jakosti in vsebujejo drugačne pomožne snovi (nedejavne sestavine), da prekrijejo neprijeten okus zdravilne učinkovine.
Patients with urea cycle disorders cannot get rid of ammonia from the body, so it can reach high levels, leading to serious problems including disability, brain damage and death.
Bolniki z motnjami ciklusa sečnine ne morejo izločiti amonijaka iz telesa, kar pomeni, da lahko ta doseže zelo visoke ravni, ki lahko povzročijo resne težave, vključno z invalidnostjo, poškodbo možganov in smrtjo.
This is a summary of the European public assessment report (EPAR) for Pheburane.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pheburane.
What are the benefits and risks of Pheburane?
Kakšne so koristi in tveganja, povezani z zdravilom Pheburane?
The Committee recommended that Pheburane be approved for use in the EU.
Priporočil je, da se zdravilo Pheburane odobri za uporabo v EU.
Because Pheburane is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Pheburane hibridno zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
This allows the levels of nitrogen in the body to decrease, reducing the amount of ammonia produced.
Tako se ravni dušika v telesu znižajo, količina proizvedenega amonijaka pa se zmanjša.
The daily dose of Pheburane is adjusted for each patient individually and depends on the patient's diet, height and weight.
Dnevni odmerek zdravila Pheburane je prilagojen za vsakega bolnika posebej in je odvisen od bolnikove prehrane, višine in telesne mase.
Pheburane is used in patients who lack one or more of the following enzymes: carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinate synthetase.
Zdravilo Pheburane se uporablja pri bolnikih, ki jim primanjkuje enega ali več naslednjih encimov: karbamil-fosfat-sintetaze, ornitintranskarbamilaze ali argininosukcinat-sintetaze.
Pheburane may be a life-long treatment unless the patient has a successful liver transplant.
Zdravljenje z zdravilom Pheburane je lahko potrebno celo življenje, če bolniku niso uspešno presajena jetra.
• 'late-onset' disease in patients who show a partial lack of one or more of these enzymes after the age of one month and have had high blood ammonia levels that affected the brain's activity.
• pri bolezni z zakasnelim pojavom pri bolnikih, ki izkazujejo delno pomanjkanje enega ali več teh encimov po prvem mesecu življenja in so imeli visoke ravni amonijaka v krvi, ki so vplivale na delovanje možganov.
It can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in treating patients with urea cycle disorders.
Izdaja zdravila je le na recept, zdravljenje pa mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z motnjami ciklusa sečnine
It is not intended to provide practical advice on how to use Pheburane.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For more information about treatment with Pheburane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Pheburane preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It is used to treat patients who have urea cycle disorders.
Uporablja se za zdravljenje bolnikov z motnjami v ciklusu sečnine.
What is Pheburane and what is it used for?
Kaj je zdravilo Pheburane in za kaj se uporablja?
The daily dose of Pheburane should be divided into equal amounts and given with each meal.
Dnevni odmerek zdravila Pheburane je treba razdeliti na enake dele in jih vzeti skupaj z obrokom.
Other information about Pheburane
Druge informacije o zdravilu Pheburane
Safety information has been included in the summary of product characteristics and the package leaflet for Pheburane, including the appropriate precautions to be followed by healthcare professionals and patients.
V povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Pheburane so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Pheburane is used with a special low-protein diet to reduce the intake of nitrogen.
Zdravilo Pheburane se uporablja s posebno dieto z malo beljakovinami za zmanjšanje vnosa dušika.
For practical information about using Pheburane, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Pheburane naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Pheburane is a ‘hybrid medicine'.
Zdravilo Pheburane je „hibridno zdravilo“.
Studies in patients have been limited to tests to determine that Pheburane is bioequivalent to the reference medicine, Ammonaps.
Študije na bolnikih so bile omejene na preskuse, s katerimi se dokazuje, da je zdravilo biološko enakovredno referenčnemu zdravilu Ammonaps.
In the body, waste nitrogen is in the form of ammonia, which is toxic when it accumulates, especially for the brain.
Odpadni dušik se v telesu nahaja v obliki amonijaka, ki je, če se kopiči, še zlasti strupen za možgane.
Phenylacetate combines with the amino acid glutamine, which contains nitrogen, to form a substance that can be removed from the body by the kidneys.
Fenilacetat se veže z aminokislino glutamin, ki vsebuje dušik, in tvori snov, ki jo lahko ledvice izločijo iz telesa.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Pheburane has been shown to have comparable quality and to be bioequivalent to Ammonaps.
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da ima zdravilo Pheburane primerljivo raven kakovosti kot zdravilo Ammonaps ter da mu je biološko enakovredno.
Why is Pheburane approved?
Zakaj je bilo zdravilo Pheburane odobreno?
Eating protein brings nitrogen into the body, which is then transformed into ammonia.
Z uživanjem beljakovin se v telo vnese dušik, ki se nato pretvori v amonijak.
The reference medicine for Pheburane is Ammonaps.
Referenčno zdravilo za zdravilo Pheburane je zdravilo Ammonaps.
Therefore, the CHMP's view was that, as for Ammonaps, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi, tako kot pri zdravilu Ammonaps, odtehtajo znana tveganja.
Pheburane is a medicine that contains the active substance sodium phenylbutyrate.
Pheburane je zdravilo, ki vsebuje zdravilno učinkovino natrijev fenilbutirat.
The active substance in Pheburane, sodium phenylbutyrate, is converted into a substance called phenylacetate in the body.
Zdravilna učinkovina zdravila Pheburane, natrijev fenilbutirat, se v telesu pretvori v snov, imenovano fenilacetat.
These patients are not able to get rid of waste nitrogen from the body because they lack some enzymes that are usually found in the liver.
Tem bolnikom primanjkuje nekaterih encimov, ki so navadno v jetrih, in zato iz telesa ne morejo izločiti odpadnega dušika.
Pheburane sodium phenylbutyrate
Povzetek EPAR za javnost natrijev fenilbutirat
How is Pheburane used?
Kako se zdravilo Pheburane uporablja?
How has Pheburane been studied?
Kako je bilo zdravilo Pheburane raziskano?
How does Pheburane work?
Kako zdravilo Pheburane deluje?
Pharmaceutical Form
Farmacevtska oblika
Immediate Packaging
Skupno pakiranje:
EU Number
Številka (EU) dovoljenja za promet
Pack size
Pot uporabe
CHMP opinion
Mnenje CHMP
It was considered that this should be reflected in the product information.
Menili so, da mora biti to izraženo v informacijah o zdravilu.
The PRAC adopted a recommendation on 17 March 2016 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Odbor PRAC je 17. marca 2016 sprejel priporočilo, ki ga je nato v skladu s členom 107k Direktive 2001/83/ES obravnavala skupina CMDh.
However ICSs are an important therapeutic option for certain patient groups as established in some treatment guidelines (GOLD report, 2015).
Vendar so IKS pomembna terapevtska možnost za določene skupine bolnikov, kakor navajajo nekatere smernice za zdravljenje (poročilo GOLD, 2015).
Episodes of acute worsening of these symptoms (exacerbations) often occur.
Pogoste so epizode akutnega poslabšanja teh simptomov (izbruhi).
All these products are restricted to ‘prescription only' status.
Izdaja vseh teh zdravil je „le na recept“.
Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.
Potem ko je odbor CHMP pregledal priporočilo odbora PRAC, se je strinjal s končnimi zaključki in podlago za priporočilo.
Since the results of the TORCH study were published in 2007, a number of large meta-analyses of pooled data have been conducted.
Od objave rezultatov študije TORCH leta 2007 je bilo opravljenih več velikih metaanaliz združenih podatkov.
Grounds for PRAC recommendation
Podlaga za priporočilo odbora PRAC
On 27 April 2015 the European Commission therefore triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of ICS containing medicinal products indicated in the treatment of COPD and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Zato je Evropska komisija 27. aprila 2015 na podlagi farmakovigilančnih podatkov sprožila napotitev v skladu s členom 31 Direktive 2001/83/ES in odbor PRAC zaprosila, naj oceni vpliv navedenih pomislekov na razmerje med tveganji in koristmi zdravil, ki vsebujejo IKS, indiciranih za zdravljenje KOPB, ter izda priporočilo o tem, ali je treba zadevna dovoljenja za promet z zdravilom ohraniti, spremeniti, začasno preklicati ali ukiniti.
The therapeutic effect of inhaled corticosteroids is considered to be the result of suppression of airway inflammation, but the airway effects of ICS in COPD are complex and the mechanism of action is not completely understood (Finney et al., 2014, Jen et al., 2012).
Velja, da je terapevtski učinek inhalacijskih kortikosteroidov posledica zavrtja vnetja dihalnih poti, vendar so učinki IKS na dihalne poti pri KOPB kompleksni, mehanizem delovanja pa ni popolnoma jasen (Finney idr., 2014, Jen idr., 2012).
• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for inhaled corticosteroids (ICS)-containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease (COPD);
• Odbor PRAC je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES, ki je bila na podlagi farmakovigilančnih podatkov sprožena za zdravila, ki vsebujejo inhalacijske kortikosteroide (IKS), indicirane za zdravljenje kronične obstruktivne pljučne bolezni (KOPB);
ICS-containing products authorised across the EU for the treatment of COPD includes the active substances beclomethasone, fluticasone propionate, fluticasone furoate, budesonide and flunisolide.
Zdravila, ki vsebujejo IKS, odobrena v EU za zdravljenje KOPB, vključujejo zdravilne učinkovine beklometazon, flutikazon propionat, flutikazon furoat, budezonid in flunizolid.
Exacerbations and comorbidities contribute to the overall severity in individual patients [Global Initiative for Obstructive Lung Disease (GOLD), 2015].
K celokupni resnosti pri posameznem bolniku prispevajo izbruhi in sočasne bolezni [Svetovna pobuda za kronično obstruktivno pljučno bolezen (GOLD), 2015].
A signal of increased risk of pneumonia in COPD patients with ICS-containing treatments was first identified in the TORCH study (Calverley et al., 2007) a large clinical study of three years treatment duration comparing the fluticasone propionate/salmeterol combination with its component parts and placebo in COPD patients.
Signal povečanega tveganja za pljučnico pri bolnikih s KOPB pri zdravilih, ki vsebujejo IKS, je bil prvič ugotovljen v študiji TORCH (Calverley idr., 2007), veliki klinični študiji triletnega zdravljenja, v kateri so primerjali kombinacijo flutikazon propionat/salmeterol z njenimi sestavnimi deli in placebom pri bolnikih s KOPB.
It is considered mechanistically plausible that a higher dose of corticosteroid could cause a greater degree of immunosuppression in the lung and lead to a higher risk of pneumonia, but this has not been demonstrated conclusively across all studies.
Velja, da je mehanično verjetno, da večji odmerek kortikosteroida lahko povzroči večjo stopnjo imunosupresije v pljučih ter vodi do večjega tveganja za pljučnico, vendar to ni bilo nesporno dokazano v vseh študijah.
No clinical trials directly examined the risk of pneumonia with ICSs head to head, and only indirect comparison in meta-analyses/systematic reviews or from observational studies is available, mainly between budesonide and fluticasone.
V nobenem kliničnem preskušanju niso z neposredno primerjavo proučevali tveganja za pljučnico pri IKS; na voljo so samo posredne primerjave iz metaanaliz/sistematičnih pregledov ali opazovalnih študij, v glavnem med budezonidom in flutikazonom.
Overall the evidence from observational studies was in agreement with the randomised clinical trials (RCT) findings and it was therefore considered that the evidence continues to support the conclusion that treatment with ICS increases the risk of pneumonia in COPD patients.
Skupno so bili dokazi iz opazovalnih študij skladni z izsledki randomiziranih kliničnih preskušanj (RKP), zato je obveljalo, da dokazi še naprej podpirajo zaključek, da zdravljenje z IKS povečuje tveganje za pljučnico pri bolnikih s KOPB.
Chronic obstructive pulmonary disease (COPD) is characterised by persistent, usually progressive, airflow limitation associated with an enhanced inflammatory response in the airways and the lungs.
Za kronično obstruktivno pljučno bolezen (KOPB) je značilna trajna, običajno napredujoča zapora dihalnih poti, povezana s povečanim vnetnim odzivom v dihalnih poteh in pljučih.
Inhaled corticosteroid (ICS) medicinal products are widely used in the treatment of COPD, as a monocomponent or in combination with a long-acting beta2 adrenergic agonist (LABA).
Inhalacijski kortikosteroidi (IKS) se pogosto uporabljajo pri zdravljenju KOPB v monoterapiji ali v kombinaciji z dolgodelujočimi agonisti adrenergičnih receptorjev beta2 (DDBA).
Results from older meta-analyses and from observational studies were also variable, with some suggesting an increased risk of pneumonia with fluticasone compared to budesonide and others finding no difference.
Tudi rezultati iz starejših metaanaliz in opazovalnih študij niso bili enotni, nekateri so kazali na povečano tveganje za pljučnico s flutikazonom v primerjavi z budezonidom, pri drugih pa razlike ni bilo.
Estimates based on the data provided suggest a patient exposure in the tens of millions across ICS as a class.
Ocene na podlagi predloženih podatkov kažejo, da je bilo razredu IKS izpostavljenih desetine milijonov bolnikov.
Overall, due to the variability in the clinical data and multiple uncertainties with study methodologies, there is no conclusive clinical evidence for intra-class differences in the magnitude of the risk among inhaled corticosteroid products.
Zaradi variabilnosti kliničnih podatkov in več negotovosti, povezanimi s študijskimi metodologijami, ni nespornih kliničnih dokazov za razlike znotraj razreda glede velikosti tveganja med inhalacijskimi kortikosteroidnimi zdravili.