natgillin/translations-raw huggingface dataset:
Mean (SEM) observed FVC change from baseline (mL) over time, studies INPULSIS-1 and INPULSIS-2 pooled bid = twice daily
Srednja (SEM) opažena promjena FVC-a od početne vrijednosti (ml) tijekom vremena, združena ispitivanja INPULSIS-1 i INPULSIS-2
Ofev 100 mg soft capsules
Ofev 100 mg meke kapsule
Pruritus, Alopecia
Poremećaji kože i potkožnog tkiva osip pruritus, alopecija
Ofev 150 mg soft capsules are available in the following pack-sizes: - 30 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters - 60 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters
Ofev 150 mg meke kapsule dostupne su u sljedećim veličinama pakiranja: - 30 x 1 mekih kapsula u aluminij/aluminij perforiranim blisterima djeljivim na jedinične doze - 60 x 1 mekih kapsula u aluminij/aluminij perforiranim blisterima djeljivim na jedinične doze
Venous thromboembolism
Venska tromboembolija
Ofev 100 mg soft capsules are available in the following pack-sizes: - 30 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters - 60 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters
Ofev 100 mg meke kapsule dostupne su u sljedećim veličinama pakiranja: - 30 x 1 mekih kapsula u aluminij/aluminij perforiranim blisterima djeljivim na jedinične doze - 60 x 1 mekih kapsula u aluminij/aluminij perforiranim blisterima djeljivim na jedinične doze
- 30 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters - 60 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters
- 30 x 1 mekih kapsula u aluminij/aluminij perforiranim blisterima djeljivim na pojedinačne doze - 60 x 1 mekih kapsula u aluminij/aluminij perforiranim blisterima djeljivim na pojedinačne doze
All-cause mortality over 52 weeks in trials INPULSIS-1, INPULSIS-2, and their pooled data - treated set
Tablica 6: Smrtnost svih uzroka tijekom 52 tjedna u ispitivanjima INPULSIS-1, INPULSIS-2 i njihovi združeni podaci - liječena skupina
Two pack-sizes of Ofev 150 mg capsules are available:
Ofev 150 mg kapsule dostupne su u dvije veličine pakiranja:
6.1 List of excipients
6.1 Popis pomoćnih tvari
See Table 5 for individual and pooled study results.
Rezultati individualnih i združenih ispitivanja mogu se vidjeti u tablici 5.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
See Table 3 for individual and pooled study results.
Rezultate individualnih i združenih ispitivanja vidjeti u tablici 3.
Two pack-sizes of Ofev 100 mg capsules are available:
Ofev 100 mg kapsule dostupne su u dvije veličine pakiranja:
In the pooled analysis of the INPULSIS trials, a numerically lower risk of first acute exacerbation was observed in patients receiving nintedanib compared to placebo.
U združenoj analizi ispitivanja INPULSIS brojčano niži rizik od prve akutne egzacerbacije IPF-a opažen je u bolesnika koji su primali nintedanib u usporedbi sa skupinom koja je primala placebo.
Hyperbilirubinaemia, Blood alkaline phosphatase (ALKP) increased
lijekom izazvano oštećenje jetre, hiperbilirubinemija, povišena alkalna fosfataza u krvi
Weight decreased, Decreased appetite
Poremećaji metabolizma i prehrane gubitak tjelesne težine, smanjeni apetit dehidracija
MARKETING AUTHORISATION NUMBER(S) EU/1/14/979/001
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/979/001
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.
Sljedeću dozu od 150 mg Ofeva morate uzeti kao uobičajeno prema predviđenom rasporedu koji Vam je preporučio liječnik ili ljekarnik.
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).
Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
NAČIN I PUT(EVI) PRIMJENE LIJEKA Primjena kroz usta.
Printing ink shellac glaze iron oxide black (E172) propylene glycol (E1520)
Tinta za označavanje šelak, glazura željezov oksid, crni (E172) propilenglikol (E1520)
Each capsule contains 150 mg nintedanib (as esilate).
Svaka kapsula sadrži 150 mg nintedaniba (u obliku nintedanibesilata).
Comparison vs placebo
Usporedba naspram placeba Omjer šansi
Each capsule contains 100 mg nintedanib (as esilate).
Svaka kapsula sadrži 100 mg nintedaniba (u obliku nintedanibesilata).
MARKETING AUTHORISATION NUMBER(S) EU/1/14/979/003
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/979/003
The treatment may be resumed at a reduced dose (100 mg twice daily) or at the full dose (150 mg twice daily).
Liječenje se može nastaviti smanjenom dozom (100 mg dvaput dnevno) ili punom dozom (150 mg dvaput dnevno).
Proportion of FVC responders at 52 weeks in trials INPULSIS-1, INPULSIS-2 and their pooled data - treated set
Tablica 3: Udio osoba s odgovorom u FVC-u nakon 52 tjedna u ispitivanjima INPULSIS-1, INPULSIS-2 i njihovi združeni podaci - liječena skupina
Table 3:
PRILOG III.
Ofev 150 mg soft capsules nintedanib
Ofev 150 mg meke kapsule nintedanib
Ofev 100 mg soft capsules nintedanib
Ofev 100 mg meke kapsule nintedanib
Ofev treatment may be resumed at a reduced dose (100 mg twice daily) or at the full dose (150 mg twice daily).
Liječenje Ofevom može se nastaviti u smanjenoj dozi (100 mg dvaput dnevno) ili u punoj dozi (150 mg dvaput dnevno).
Wound healing complication
Komplikacije pri cijeljenju rana
- if you have high blood pressure - if you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall
Vaš liječnik će odlučiti kada nastaviti liječenje ovim lijekom; - ako imate visok krvni tlak; - ako imate ili ste imali aneurizmu (proširenje i slabljenje stijenke krvne žile) ili rascjep stijenke krvne žile.
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).
Liječenje Ofevom ne preporučuje se u bolesnika s umjerenim (Child Pugh B) i teškim (Child Pugh C) oštećenjem funkcije jetre (vidjeti dio 5.2).
s r.o.
FVC-u
Ofev treatment may be resumed at the full dose (150 mg twice daily) or a reduced dose (100 mg twice daily).
Liječenje Ofevom tada se može nastaviti u punoj dozi (150 mg dvaput dnevno) ili u smanjenoj dozi (100 mg dvaput dnevno).
Headache
Doziranje
No increased frequency of impaired wound healing was observed in the INPULSIS trials.
U ispitivanjima INPULSIS nije opažena povećana učestalost usporenog cijeljenja rana.
Triglycerides, medium-chain, hard fat, soya lecithin (E322) (see section 2) Capsule shell: Gelatin, glycerol (85%), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172)
želatina, glicerol (85%), titanijev dioksid (E171), crveni željezov oksid (E172), žuti željezov oksid (E172)
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 100 mg nintedanib (as esilate).
NAVOĐENJE DJELATNE(IH) TVARI Jedna kapsula sadrži 100 mg nintedaniba (u obliku nintedanibesilata).
Nintedanib inhibits proliferation, migration and fibroblast to myofibroblast transformation of human lung fibroblasts from patients with IPF.
U fibroblastima izoliranim iz pluća bolesnika s IPF-om nintedanib inhibira proliferaciju, migraciju i transformaciju fibroblasta u miofibroblaste.
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 150 mg nintedanib (as esilate).
NAVOĐENJE DJELATNE(IH) TVARI Jedna kapsula sadrži 150 mg nintedaniba (u obliku nintedanibesilata).
Reporting of side effects
Pomoćna tvar s poznatim učinkom
NAME OF THE MEDICINAL PRODUCT Ofev 100 mg capsules nintedanib
NAZIV LIJEKA Ofev 100 mg kapsule nintedanib
NAME OF THE MEDICINAL PRODUCT Ofev 150 mg capsules nintedanib
NAZIV LIJEKA Ofev 150 mg kapsule nintedanib
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”.
Ofev 150 mg kapsule su neprozirne, duguljaste, meke želatinske kapsule smeđe boje, koje na jednoj strani imaju u crnoj boji utisnut logo tvrtke Boehringer Ingelheim i oznaku „150“.
- If you get any side effects, talk to your doctor or pharmacist.
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
Diarrhoea
Dojenje
Ofev 150 mg soft capsules are brown-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and “150”.
Ofev 150 mg meke kapsule su neprozirne, duguljaste, meke želatinske kapsule smeđe boje, koje na jednoj strani imaju u crnoj boji utisnut logo tvrtke Boehringer Ingelheim i oznaku „150“.
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”.
Ofev 100 mg kapsule su neprozirne, duguljaste, meke želatinske kapsule, boje breskve koje na jednoj strani imaju u crnoj boji utisnut logo tvrtke Boehringer Ingelheim i oznaku „100“.
Boehringer Ingelheim Sp. z o.o.
Boehringer Ingelheim Ellas A.E.
NAME OF THE MEDICINAL PRODUCT Ofev 100 mg soft capsules nintedanib
NAZIV LIJEKA Ofev 100 mg meke kapsule nintedanib
Do not take more than the recommended dose of two Ofev 100 mg capsules per day if your daily dose was reduced to 200 mg per day.
Ako Vam je dnevna doza smanjena na 200 mg dnevno, ne uzimajte više od preporučene doze od dvije Ofev 100 mg kapsule dnevno.
NAME OF THE MEDICINAL PRODUCT Ofev 150 mg soft capsules nintedanib
NAZIV LIJEKA Ofev 150 mg meke kapsule nintedanib
In view of the limited number of patients, this study detected only the most frequent adverse events and showed an increase in gastrointestinal adverse events and a trend toward increased hepatic adverse events.
s Ofevom 150 mg dvaput dnevno i dodatkom pirfenidona tijekom 12 tjedana opisani su u dijelu 5.1. S obzirom na ograničeni broj bolesnika, ovo je ispitivanje otkrilo samo najčešće štetne događaje te pokazalo povećanje gastrointestinalnih štetnih događaja i trend ka povećanim jetrenim štetnim događajima.
United Kingdom Boehringer Ingelheim Ltd. Tel: +44 1344 424 600
Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 600
One soft capsule contains 150 mg nintedanib (as esilate) Excipient with known effect
Jedna meka kapsula sadrži 150 mg nintedaniba (u obliku nintedanibesilata).
Haemorrhage
Proljev
Luxembourg/Luxemburg SCS Boehringer Ingelheim Comm.V Tél/Tel: +32 2 773 33 11
Luxembourg/Luxemburg SCS Boehringer Ingelheim Comm.V
Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620
Česká republika Boehringer Ingelheim spol. s r.o. Tel: +420 234 655 111
One soft capsule contains 100 mg nintedanib (as esilate) Excipient with known effect
Jedna meka kapsula sadrži 100 mg nintedaniba (u obliku nintedanibesilata).
Time to progression (≥ 10% absolute decline of FVC % predicted or death) In both INPULSIS trials, the risk of progression was statistically significantly reduced for patients treated with nintedanib compared with placebo.
U oba ispitivanja INPULSIS rizik od progresije bio je statistički značajno smanjen u bolesnika liječenih nintedanibom u usporedbi s placebom.
Česká republika Boehringer Ingelheim spol.
United Kingdom Boehringer Ingelheim Ltd.
Boehringer Ingelheim Ellas A.E. Tηλ: +30 2 10 89 06 300
Boehringer Ingelheim Sp. z o.o. Tel: +48 22 699 0 699
Renal failure (see section 4.4)
Poremećaji bubrega i mokraćnog sustava zatajenje bubrega (vidjeti dio 4.4)
Pharmaceutical Form
Farmaceutski oblik
Strength
Doza
EU Number
Broj (EU) odobrenja (Zaštićeno) ime
Immediate Packaging
Put primjene Unutarnje pakovanje
Pack size
Veličina pakovanja
It was considered that this should be reflected in the product information.
Smatra se da je to potrebno navesti u informacijama o proizvodu.
CHMP opinion
Mišljenje CHMP-a
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.
PRAC je 17. ožujka 2016. usvojio preporuku koju je zatim razmatrao CHMP u skladu s člankom 107.k Direktive 2001/83/EZ.
Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.
Nakon što je pregledao preporuku PRAC-a, CHMP suglasan je s općim znanstvenim zaključcima i razlozima za preporuku PRAC-a.
However ICSs are an important therapeutic option for certain patient groups as established in some treatment guidelines (GOLD report, 2015).
Međutim, ICS je važna terapijska opcija za određene skupine pacijenata, kao što je utvrđeno u određenim smjernicama za liječenje (izvješće GOLD-a,
Since the results of the TORCH study were published in 2007, a number of large meta-analyses of pooled data have been conducted.
Otkako su rezultati ispitivanja TORCH objavljeni u 2007., proveden je niz velikih meta-analiza objedinjenih podataka.
Grounds for PRAC recommendation
Razlozi za preporuku PRAC-a
Episodes of acute worsening of these symptoms (exacerbations) often occur.
Često se javljaju epizode akutnog pogoršanja tih simptoma (egzacerbacije).
Overall summary of the scientific evaluation by the PRAC
Cjelokupan sažetak znanstvene ocjene PRAC-a
Estimates based on the data provided suggest a patient exposure in the tens of millions across ICS as a class.
Procjene koje se temelje na dostavljenim podacima upućuju na izloženost desetaka milijuna pacijenata ICS-u kao razredu.
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).
Terapijski učinak inhalacijskih kortikosteroida smatra se rezultatom suzbijanja upale dišnih puteva, ali su učinci ICS-a na dišne putove u slučaju KOPB-a složeni i mehanizam djelovanja još nije u potpunosti poznat (Finney et al., 2014., Jen et al., 2012.).
All these products are restricted to ‘prescription only' status.
Svi ti proizvodi ograničeni su na status lijeka dostupnog samo na liječnički recept.
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.
Europska je komisija stoga 27. travnja 2015. pokrenula postupak upućivanja u skladu s člankom 31. Direktive 2001/83/EZ na temelju farmakovigilancijskih podataka te je zatražila od PRAC-a da ocijeni utjecaj navedenih zabrinjavajućih podataka na omjer koristi i rizika od lijekova koji sadrže ICS indiciranih u liječenju KOPB-a te da izda preporuku o tome treba li odobrenja za stavljanje u promet zadržati, izmijeniti, obustaviti ili opozvati.
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.
Kroničnu opstruktivnu plućnu bolest (KOPB) obilježava stalno, obično progresivno, ograničenje protoka zraka povezano s pojačanom upalnom reakcijom u dišnim putovima i plućima.
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.
Ni jedno kliničko ispitivanje nije izravno ispitivalo rizik od pneumonije kod upotrebe ICS-a i dostupna je samo neizravna usporedba meta-analiza/sistematskih revizija ili iz studija promatranja, uglavnom između budezonida i flutikazona.
Some evidence suggests an increased risk of pneumonia with increasing steroid dose.
Neki dokazi upućuju na povećan rizik od pneumonije s povećanjem doze steroida.
• 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);
• PRAC je razmotrio postupak u skladu s člankom 31. Direktive 2001/83/EZ koji proizlazi iz podataka o farmakovigilanciji za lijekove koji sadrže inhalacijske kortikosteroide indicirane u liječenju kronične opstruktivne plućne bolesti (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.
Lijekovi koji sadrže ICS odobreni na području EU-a za liječenje KOPB-a uključuju aktivne tvari beklometazon, flutikazon propionat, flutikazon furoat, budezonid i flunisolid.
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).
Lijekovi koji sadrže inhalacijske kortikosteroide (ICS) učestalo se upotrebljavaju u liječenju KOPB-a, kao jedini sastojak ili u kombinaciji s beta2-adrenergičkim agonistom produženog djelovanja (LABA).
Although a number of common criticisms can be levelled at the studies included in these meta-analyses, including difficulties with the accurate identification of pneumonia (particularly pre-TORCH studies), variations in participant populations and comparators, differential withdrawal rates, and trials not specifically powered to detect pneumonia, a consistent association between ICS use and increased risk of pneumonia in COPD patients was seen across the meta-analyses.
Iako se niz općih kritika može uputiti ispitivanjima uključenima u tim metaanalizama, uključujući poteškoće s točnom identifikacijom pneumonije (posebno u ispitivanjima provedenima prije ispitivanja TORCH), varijacije u populacijama sudionika i usporednim lijekovima, različite stope povlačenja i ispitivanja koja nisu posebno bila namijenjena otkrivanju pneumonije, postojana povezanost između upotrebe ICS-a i povećanog rizika od pneumonije kod pacijenata s KOPB-om uočena je u svim meta-analizama.
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.
Smatra se objašnjivim s mehanističkog stajališta da veća doza kortikosteroida može uzrokovati veći stupanj imunosupresije u plućima i dovesti do većeg rizika od pneumonije, ali to nije definitivno dokazano u svim ispitivanjima.
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.
Rezultati starijih meta-analiza i studija promatranja također su promjenjivi pa tako neki upućuju na veći rizik od pneumonije kod upotrebe flutikazona u usporedbi s budezonidom, dok drugi rezultati ne upućuju na razliku.
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.
Općenito govoreći, zbog promjenjivosti kliničkih podataka i višestrukih nesigurnosti u vezi s metodologijama ispitivanja, ne postoje uvjerljivi klinički dokazi koji bi upućivali na razlike unutar razreda u razmjeru rizika među inhalacijskim kortikosteroidima.
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.
Naznake povećanog rizika od pneumonije kod pacijenata s KOPB-om čije liječenje uključuje ICS prvi su put uočene u ispitivanju TORCH (Calverley et al., 2007), velikom kliničkom ispitivanju trogodišnjeg liječenja tijekom kojeg se kod pacijenata s KOBP-om uspoređivala kombinacija flutikazon propionata/salmetrola i njihovih sastavnica s placebom.
Further, it was recognised that there are difficulties associated with the differential diagnosis of pneumonia or an exacerbation of COPD.
Nadalje, prepoznato je da postoje teškoće povezane s različitim dijagnozama pneumonije ili egzacerbacijom KOPB-a.
• The PRAC considered that some evidence of an increased risk of pneumonia with increasing steroid dose exists, although this has not been demonstrated conclusively across all studies;
• PRAC je zaključio da postoje određeni dokazi o povećanju rizika od pneumonije kao rezultat povećanja doze steroida, iako to nije definitivno dokazano u svim ispitivanjima;
• The PRAC also concluded that there is no conclusive clinical evidence for intra-class differences in the magnitude of the risk among ICS-containing products;
• PRAC je također zaključio da ne postoje uvjerljivi klinički dokazi koji bi upućivali na razlike unutar razreda u razmjeru rizika među lijekovima koji sadrže ICS;
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.
Ukupni dokazi iz studija promatranja bili su u skladu s otkrićima randomiziranih kliničkih ispitivanja (RCT) i stoga se smatralo da dokazi i dalje podupiru zaključak da liječenje ICS-om povećava rizik od pneumonije kod pacijenata s KOPB-om.
Due to a paucity of data regarding the potential effects of other classes of medication prescribed for COPD, no conclusions could be drawn regarding the influence of concomitant medications on the risk of pneumonia in COPD patients.
Zbog manjka podataka u vezi s potencijalnim učincima drugih razreda lijekova koji se propisuju za KOPB, nije bilo moguće izvući zaključke o utjecaju istodobno korištenih lijekova na rizik od pneumonije kod pacijenata s KOPB-om.
Since then other products containing ICS have been subject to review and it was considered that data on the risk of pneumonia with these products in the COPD population should be reviewed all together, so that the risk of pneumonia in this patient population could be further characterised.
Otada su drugi lijekovi koji sadrže ICS postali predmetom revizija i smatra se da podatke o rizicima od pneumonije povezane s upotrebom tih lijekova u liječenju populacije pacijenata s KOPB-om treba u cijelosti revidirati, kako bi se rizik od pneumonije u toj populaciji pacijenata mogao dodatno precizirati.
It was acknowledged that any risk of pneumonia with ICS should be considered in context, as pneumonia is an intrinsic comorbidity to COPD with certain predisposing factors making some COPD patients more susceptible to this risk than others.
Potvrđeno je da se rizik od pneumonije kod ICS-a treba razmatrati u kontekstu, s obzirom na to da je pneumonija intrinzični komorbiditet KOPB-a s određenim predispozicijskim čimbenicima koji pacijente s KOPB-om čine podložnijima tom riziku od drugih.
The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for ICS-containing medicinal products indicated in the treatment of COPD.
Odbor je, slijedom toga, preporučio izmjene uvjeta za odobrenje za stavljanje u promet lijekova koji sadržavaju ICS indiciranih u liječenju KOPB-a.
Finally, the PRAC considered the ICS dose-response effect or the influence of LABA and other concomitant medications on the risk of pneumonia in COPD patients.
Naposljetku, PRAC je razmotrio učinak s obzirom na reakcije na dozu ICS-a ili utjecaj LABA i drugih istodobno korištenih lijekova na rizik od pneumonije kod pacijenata s KOPB-om.