natgillin/translations-raw huggingface dataset:
4 A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8,100 patients in the pioglitazone-treated groups and 7,400 in the comparator-treated groups of up to 3.5 years duration.
4 Provedena je analiza objedinjenih podataka o prijelomima kostiju kao nuspojavama u randomiziranim, usporednim lijekom kontroliranim, dvostruko slijepim kliničkim ispitivanjima u više od 8100 bolesnika u skupinama liječenima pioglitazonom i 7400 bolesnika u skupinama liječenima usporednim lijekom u trajanju do 3,5 godine.
Blurred vision due to swelling (or fluid) at the back of the eye has also been reported in patients taking Glustin (frequency cannot be estimated from the available data).
U bolesnika koji uzimaju Glustin zabilježen je i zamagljen vid zbog oticanja (ili nakupljanja tekućine) na stražnjoj strani oka (učestalost se ne može procijeniti iz dostupnih podataka).
Bladder Cancer
Karcinom mokraćnog mjehura
Localised swelling (oedema) has also been experienced very commonly (may affect more than 1 in 10 people) in patients taking Glustin in combination with insulin.
Lokalizirano oteknuće (edemi) također su vrlo često (mogu se pojaviti kod više od 1 na 10 osoba) nastajali u bolesnika koji su uzimali Glustin u kombinaciji s inzulinom.
There may be an increased possibility of becoming pregnant because you may ovulate again when you take Glustin.
Kad uzimate Glustin, možete ponovno imati ovulaciju pa mogućnost trudnoće može biti povećana.
Each tablet contains 114.51 mg of lactose monohydrate (see section 4.4).
Pomoćna tvar s poznatim učinkom Jedna tableta sadrži 114,51 mg laktoza hidrata (vidjeti dio 4.4).
Each tablet contains 76.34 mg of lactose monohydrate (see section 4.4).
Pomoćna tvar s poznatim učinkom Jedna tableta sadrži 76,34 mg laktoza hidrata (vidjeti dio 4.4).
Each tablet contains 92.87 mg of lactose monohydrate (see section 4.4).
Pomoćna tvar s poznatim učinkom Jedna tableta sadrži 92,87 mg laktoza hidrata (vidjeti dio 4.4).
Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Glustin.
Karcinom mokraćnog mjehura manje je često (može se pojaviti u do 1 na 100 osoba) nastao u bolesnika koji uzimaju Glustin.
Frequency of adverse reactions of pioglitazone by treatment regimen Monotherapy
Učestalost nuspojava pioglitazona prema režimu liječenja
common common uncommon macular oedema not known not known not known not known not known
često često manje često makularni edem nepoznato nepoznato nepoznato nepoznato nepoznato Poremećaji uha i labirinta vrtoglavica manje često
Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the plasma concentration of pioglitazone (see section 4.5)
Zabilježeno je da istovremena primjena pioglitazona s gemfibrozilom (inhibitor citokroma P450 2C8) povećava, a s rifampicinom (induktor citokroma P450 2C8) snižava koncentracije pioglitazona u plazmi (vidjeti dio 4.5).
1 Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported.
1 Nakon stavljanja lijeka na tržište, kod bolesnika koji su liječeni pioglitazonom prijavljeni su slučajevi reakcija preosjetljivosti.
- if you have or have ever had bladder cancer.
ako imate ili ste imali karcinom mokraćnog mjehura. ako imate krv u mokraći, a niste proveli odgovarajuće pretrage.
The other side effects that have been experienced by some patients taking Glustin are:
Ostale nuspojave koje su osjetili neki bolesnici koji uzimaju
Allergic reactions have been reported with frequency not known (cannot be estimated from the available data) in patients taking Glustin.
Kod bolesnika koji su uzimali Glustin prijavljene su alergijske reakcije s nepoznatom učestalosti (ne može se procijeniti iz dostupnih podataka).
- if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss,
ako imate zatajenje srca ili ste prije imali zatajenje srca. ako imate bolest jetre. ako imate dijabetičku ketoacidozu (komplikacija šećerne bolesti koja uzrokuje nagli gubitak na tjelesnoj težini, mučninu i povraćanje).
Glustin 30 mg tablets
Glustin 30 mg tablete
Glustin 45 mg tablets
Glustin 45 mg tablete
EU/1/00/151/003 EU/1/00/151/004 EU/1/00/151/005 EU/1/00/151/006 EU/1/00/151/007 EU/1/00/151/008 EU/1/00/151/009 EU/1/00/151/010 EU/1/00/151/011 EU/1/00/151/012 EU/1/00/151/013 EU/1/00/151/014 EU/1/00/151/015 EU/1/00/151/016 EU/1/00/151/017 EU/1/00/151/018 EU/1/00/151/019 EU/1/00/151/020 EU/1/00/151/021 EU/1/00/151/022 EU/1/00/151/023 EU/1/00/151/024
EU/1/00/151/011 EU/1/00/151/012 EU/1/00/151/013 EU/1/00/151/014 EU/1/00/151/015 EU/1/00/151/016 EU/1/00/151/017 EU/1/00/151/018 EU/1/00/151/019 EU/1/00/151/020 EU/1/00/151/021 EU/1/00/151/022 EU/1/00/151/023 EU/1/00/151/024
Glustin 15 mg tablets
Glustin 15 mg tablete
Each Glustin 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
Jedna tableta lijeka Glustin od 30 mg sadrži 30 mg pioglitazona (u obliku pioglitazonklorida).
- Glustin 45 mg tablets are white to off-white, round, flat tablets marked “45” on one face, “AD4” on the other.
Glustin 45 mg tablete su bijele do gotovo bijele boje, okrugle, plosnate, s oznakom ‘45' na jednoj strani i ‘AD4' na drugoj strani.
Glustin 15 mg tablets Glustin 30 mg tablets Glustin 45 mg tablets
Glustin 30 mg tablete Glustin 45 mg tablete pioglitazon
Each Glustin 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
Jedna tableta lijeka Glustin od 45 mg sadrži 45 mg pioglitazona (u obliku pioglitazonklorida).
Each Glustin 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
Jedna tableta lijeka Glustin od 15 mg sadrži 15 mg pioglitazona (u obliku pioglitazonklorida).
Glustin 30 mg tablets are white to off-white, round, flat tablets marked “30” on one face, “AD4” on the other.
Glustin 30 mg tablete su bijele do gotovo bijele boje, okrugle, plosnate, s oznakom ‘30' na jednoj strani i ‘AD4' na drugoj strani.
EU/1/00/151/008 14 tablets EU/1/00/151/004 28 tablets EU/1/00/151/017 30 tablets EU/1/00/151/005 50 tablets EU/1/00/151/024 56 tablets EU/1/00/151/018 84 tablets EU/1/00/151/019 90 tablets EU/1/00/151/006 98 tablets
EU/1/00/151/008 14 tableta EU/1/00/151/004 28 tableta EU/1/00/151/017 30 tableta EU/1/00/151/005 50 tableta EU/1/00/151/024 56 tableta EU/1/00/151/018 84 tableta EU/1/00/151/019 90 tableta EU/1/00/151/006 98 tableta
Glustin 45 mg tablets pioglitazone
NAZIV LIJEKA Glustin 45 mg tablete pioglitazon
EU/1/00/151/009 14 tablets EU/1/00/151/010 28 tablets EU/1/00/151/020 30 tablets EU/1/00/151/011 50 tablets EU/1/00/151/012 56 tablets EU/1/00/151/021 84 tablets EU/1/00/151/022 90 tablets EU/1/00/151/013 98 tablets
EU/1/00/151/009 14 tableta EU/1/00/151/010 28 tableta EU/1/00/151/020 30 tableta EU/1/00/151/011 50 tableta EU/1/00/151/012 56 tableta EU/1/00/151/021 84 tableta EU/1/00/151/022 90 tableta EU/1/00/151/013 98 tableta
Glustin 15 mg tablets pioglitazone
NAZIV LIJEKA Glustin 15 mg tablete pioglitazon
Glustin 30 mg tablets pioglitazone
NAZIV LIJEKA Glustin 30 mg tablete pioglitazon
- Glustin 15 mg tablets are white to off-white, round, convex tablets marked “15” on one face, “AD4” on the other.
Glustin 15 mg tablete su bijele do gotovo bijele boje, okrugle, konveksne, s oznakom ‘15' na jednoj strani i ‘AD4' na drugoj strani.
EU/1/00/151/007 14 tablets EU/1/00/151/001 28 tablets EU/1/00/151/014 30 tablets EU/1/00/151/002 50 tablets EU/1/00/151/023 56 tablets EU/1/00/151/015 84 tablets EU/1/00/151/016 90 tablets EU/1/00/151/003 98 tablets
EU/1/00/151/007 14 tableta EU/1/00/151/001 28 tableta EU/1/00/151/014 30 tableta EU/1/00/151/002 50 tableta EU/1/00/151/023 56 tableta EU/1/00/151/015 84 tableta EU/1/00/151/016 90 tableta EU/1/00/151/003 98 tableta
The tablets are white to off-white, round, flat and marked ‘45' on one face, ‘AD4' on the other.
Tablete su bijele do gotovo bijele boje, okrugle, plosnate i imaju oznaku ‘45' s jedne strane i ‘AD4' s druge strane.
The tablets are white to off-white, round, flat and marked ‘30' on one face, ‘AD4' on the other.
Tablete su bijele do gotovo bijele boje, okrugle, plosnate i imaju oznaku ‘30' s jedne strane i ‘AD4' s druge strane.
The tablets are white to off-white, round, convex and marked ‘15' on one face, ‘AD4' on the other.
Tablete su bijele do gotovo bijele boje, okrugle, konveksne i imaju oznaku ‘15' s jedne strane i ‘AD4' s druge strane.
Glustin 30 mg
PODACI NA BRAILLEOVOM PISMU Glustin 30 mg
Glustin 45 mg
PODACI NA BRAILLEOVOM PISMU Glustin 45 mg
EU/1/00/151/001 EU/1/00/151/002
EU/1/00/151/001 EU/1/00/151/002 EU/1/00/151/003 EU/1/00/151/004 EU/1/00/151/005 EU/1/00/151/006 EU/1/00/151/007 EU/1/00/151/008 EU/1/00/151/009 EU/1/00/151/010
Sun.
C.
Package leaflet: Information for the patient Glustin 15 mg tablets
KVALITATIVNI I KVANTITATIVNI SASTAV Glustin 15 mg tablete
Glustin 15 mg
PODACI NA BRAILLEOVOM PISMU Glustin 15 mg
56 capsules
56 kapsula
EU/1/15/1075/001
EU/1/15/1075/001 Feraccru
30 mg Capsule, hard Oral use bottle (HDPE)
30 mg Kapsula, tvrda Peroralna primjena Bočica (HDPE)
EU (MA) Number
EU (MA) broj
26 July 2013
26. srpnja 2013.
It has been authorised in the European Union since 4 April 2008.
Odobren je u Europskoj uniji od 4. travnja 2008. godine.
The withdrawal letter is available here.
Dopis o povlačenju zahtjeva dostupan je ovdje.
The full European Public Assessment Report for Effentora can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Cjelokupno Europsko javno izvješće o ocjeni dokumentacije o lijeku za Effentora možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Ako ste uključeni u kliničko ispitivanje te Vam je potrebno više informacija o Vašem liječenju, obratite se liječniku koji Vam pruža liječenje.
In all of the studies, the main measure of effectiveness was the change in pain intensity in the 60 minutes after taking the tablet.
U svim ispitivanjima, glavna mjera djelotvornosti bila je promjena u intenzitetu boli u roku od 60 minuta nakon uzimanja tablete.
Each patient ranked their pain intensity on a scale of 0 to 10.
Svaki je bolesnik rangirao intenzitet boli na skali od 0 do 10.
It is a well-known substance, which has been used to control pain for many years.
Ovo je vrlo dobro poznata tvar, koja se koristi već dugi niz godina za kontrolu boli.
The duration of treatment was determined by the time needed by each patient to control 9 episodes of breakthrough pain within a 21-day period.
Trajanje liječenja utvrđeno je vremenom potrebnim da svaki bolesnik kontrolira 9 epizoda prodorne boli unutar razdoblja od 21 dan.
In its official letter, the company stated that it decided to withdraw the application after the CHMP indicated that the data submitted were not sufficient to address the Committee's concerns.
U svojem službenom dopisu, tvrtka je navela da je odlučila povući zahtjev nakon što je CHMP naveo da dostavljeni podaci nisu dostatni za odstranjivanje zabrinutosti Povjerenstva.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Effentora.
Tvrtka je obavijestila CHMP da ovo nema posljedica za bolesnike koji su trenutno uključeni u klinička ispitivanja s lijekom Effentora.
The active substance in Effentora, fentanyl, is an opioid.
Djelatna tvar u Effentora, fentanil, je opioid.
What consequences does this withdrawal have for patients in clinical trials?
Koje posljedice ima ovo povlačenje za bolesnike u kliničkim ispitivanjima ili u programima milosrdnog davanja lijekova?
There are no consequences on the use of Effentora in its authorised indication.
Nema posljedica za korištenje lijeka Effentora u odobrenoj indikaciji.
The effects of Effentora were compared with those of placebo (a dummy treatment) in 79 patients with neuropathic pain (pain due to nerve damage) in one study, and in 77 patients with lowback pain in a second study.
Djelovanje lijeka Effentora uspoređeno je s djelovanjem placebo lijeka (lažnog liječenja) u 79 bolesnika s neuropatskom boli (boli zbog oštećenja živca) u jednom ispitivanju, i u 77 bolesnika s boli u donjem dijelu leđa u drugom ispitivanju.
Effentora is available as ‘buccal tablets' (tablets that dissolve in the mouth).
Lijek Effentora dostupan je u obliku „bukalnih tableta“ (tableta koje se otapaju u ustima).
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Zahtjev je povučen nakon što je CHMP ocijenio dokumentaciju koju je tvrtka dostavila te sastavio popis pitanja.
Once absorbed, fentanyl acts on receptors in the brain and spinal cord to control pain.
Nakon što se apsorbira, fentanil djeluje na receptore u mozgu i leđnoj moždini kako bi se kontrolirala bol.
What was Effentora expected to be used for?
Za što se Effentora trebao koristiti?
On 11 July 2013, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Effentora, to extend the treatment for breakthrough pain to adult patients with chronic (long-term) persistent pain from causes other than cancer.
Dana 11. srpnja 2013. godine, Teva Pharma B.V. službeno je obavijestio Povjerenstvo za humane lijekove (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje lijeka u promet zbog nove indikacije za lijek Effentora da bi proširio liječenje za prodornu bol u odraslih bolesnika s kroničnom (dugoročnom) perzistirajućom boli prouzročenom drugim uzrocima osim rakom.
After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Nakon što je CHMP ocijenio odgovore tvrtke na posljednji popis pitanja, još su uvijek postojale neke nedoumice.
The third study, which lasted for 12 weeks, looked at the effects of Effentora in 148 patients with non-cancer-related longterm pain.
Trećim ispitivanjem, koje je trajalo 12 tjedana, ispitano je djelovanje lijeka Effentora u 148 bolesnika s dugoročnom boli koja nije povezana s rakom.
How was Effentora expected to work?
Kako je Effentora trebao djelovati?
What is happening with Effentora for the treatment ‘breakthrough' pain in adults with cancer?
Što se događa s lijekom Effentora kada je riječ o liječenju „prodorne“ boli u odraslih osoba oboljelih od raka?
The applicant presented data from 3 main studies in adults with breakthrough pain already using opioids.
Podnositelj zahtjeva dostavio je podatke iz 3 glavna ispitivanja provedena u odraslih osoba s prodornom boli koji već koriste opioide.
Breakthrough pain is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.
Prodorna bol nastupa kada bolesnik osjeti dodatnu, iznenadnu bol usprkos neprekidnom liječenju analgeticima.
It is already used to treat ‘breakthrough' pain in adults with cancer who are using opioid painkillers to control long-term cancer pain.
Već se koristi za liječenje „prodorne“ boli u odraslih osoba oboljelih od raka, koji koriste opioidne analgetike za kontrolu dugoročne boli uzrokovane rakom.
The Committee also had concerns that the patients in the studies had high levels of background pain and might not have been representative of the intended treatment group, which consists of patients with breakthrough pain but whose background pain is otherwise well controlled by regular opioid treatment.
Povjerenstvo je također iskazalo zabrinutost budući da su pacijenti obuhvaćeni ispitivanjima imali visoke razine pozadinske boli, a postoji mogućnost da nisu bili reprezentativni za predviđenu terapijsku grupu, koja se sastoji od bolesnika s prodornom boli, no čija se pozadinska bol može dobro regulirati redovnim liječenjem opioidima.
In adults with long-term pain due to causes other than cancer, Effentora was expected to work in the same way as it does in adults with cancer pain.
U odraslih osoba s dugotrajnom boli prouzročenom drugim uzrocima osim rakom, Effentora je trebao djelovati na isti način kao i u odraslih osoba s boli uzrokovanom rakom.
The CHMP considered that, although the use of Effentora is accepted in cancer patients who have limited survival, further data were needed to support its safe use in adults with non-cancer-related pain, who have normal life expectancy and may need long-term treatment.
CHMP je smatrao da, iako je uporaba lijeka Effentora prihvaćena u bolesnika oboljelih od raka koji imaju ograničene izglede za preživljavanje, su potrebni daljnji podaci u prilog sigurne uporabe lijeka u odraslih osoba s boli koja nije povezana s rakom, a koji imaju normalno očekivano trajanje života te mogu imati potrebe za dugotrajnim liječenjem.
Effentora was also expected to be used to treat breakthrough pain in adults with long-term persistent pain from causes other than cancer, who were already receiving regular treatment with opioids to control their persistent pain.
Effentora se trebao koristiti za liječenje prodorne boli u odraslih osoba s dugoročnom perzistirajućom boli prouzročenom drugim uzrocima osim rakom, koji su već prethodno primali redovno liječenje opioidima za kontrolu njihove perzistirajuće boli.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Effentora could not have been approved for the treatment of breakthrough pain in adults with long-term pain other than cancer pain.
Na temelju pregleda podataka te odgovora tvrtke na popis pitanja CHMP-a, u trenutku povlačenja, CHMP je izrazio svoju zabrinutost oko određenih pitanja te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za Effentora za liječenje prodorne boli u odraslih osoba s dugoročnom boli, izuzev za bol uzrokovanom rakom.
The Committee noted that several cases of misuse or abuse of the medicine had been reported in the studies, and was concerned about the risk of addiction in non-cancer patients when using Effentora in the long term.
Povjerenstvo je uočilo da je u ispitivanjima prijavljeno nekoliko slučaja zlouporabe ili prekomjerne uporabe lijeka te je bilo zabrinuto zbog rizika od ovisnosti u bolesnika koji nisu oboljeli od raka prilikom dugotrajne uporabe lijeka Effentora.
In Effentora, it is given as a buccal tablet, so that fentanyl is absorbed through the lining of the mouth.
Fentanil je u lijeku Effentora dostupan u obliku bukalnih tableta, tako da se apsorbira kroz sluznicu usta.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Effentora in patients with non-cancer-related long-term pain did not outweigh its risks.
Sukladno navedenome, u vrijeme povlačenja, CHMP je smatrao kako koristi lijeka Effentora ne nadmašuju s njim povezane rizike u bolesnika s dugoročnom boli koja nije povezana s rakom.
Package Leaflet:
Nuspojave:
Anakinra - Thrombocytopenia (EPITT no 18337)
Anakinra - trombocitopenija (EPITT br. 18337)
In clinical studies in RA and CAPS patients, thrombocytopenia has been reported in 1.9% of treated patients compared to 0.3% in the placebo group.
U kliničkim ispitivanjima provedenim u bolesnika s RA-om i CAPS-om, trombocitopenija je prijavljena u 1,9°% liječenih bolesnika, u usporedbi s 0,3°% bolesnika u skupini koja je primala placebo.
Adopted at the 5-8 October 2015 PRAC
Usvojeno na sjednici PRAC-a 5. - 8. listopada 2015.
New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/661880/2015
Novi tekst informacija o lijeku - izvadak iz preporuka PRAC-a vezanih uz signale EMA/PRAC/680915/2015
Thrombocytopenia
Trombocitopenija
Blood and lymphatic system disorders Frequency ‘common': thrombocytopenia
Poremećaji krvnog i limfnog sustava Učestalost "često": trombocitopenija
The thrombocytopenias have been mild, i.e. platelet counts have been >75 x109/l.
Trombocitopenija je bila blažeg oblika, tj. broj trombocita je bio >75 x109/l.
New product information wording - Extracts from PRAC recommendations on signals
Novi tekst informacija o lijeku - izvadak iz preporuka PRAC-a vezanih uz signale
During post-marketing use of Kineret, thrombocytopenia has been reported, including occasional case reports indicating severe thrombocytopenia (i.e. platelet counts <10 x109/l).
Tijekom primjene lijeka Kineret nakon stavljanja u promet prijavljena je trombocitopenija, uključujući i povremene prijave slučajeva koji ukazuju na tešku trombocitopeniju (tj. broj trombocita <10 x109/l).
Common side effects (may affect up to 1 in 10 people): - Thrombocytopenia (low level of blood platelets).
Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba): - Trombocitopenija (smanjen broj trombocita u krvi).
Summary of Product Characteristics: Section 4.8 - Undesirable effects:
Sažetak opisa svojstava lijeka: Dio 4.8.
Possible side effects
Uputa o lijeku: 4. Moguće nuspojave
1 bag
1 vrećica
EU/1/16/1121/001 Zalmoxis
EU/1/16/1121/001 Zalmoxis 5-20 x 106 stanica/ml
Intravenous use Ethylen-vinyl-acetate cryo bag (EVA)
Krio vrećica od etilen vinil acetat (EVA)
Dispersion for infusion
Disperzija za infuziju
ml
Doza
Immediate Packaging Content Pack size
Sastav Veličina pakovanja
Czech Republic AstraZeneca UK Limited 2 Kingdom Street
Češka Republika AstraZeneca UK Limited 2 Kingdom Street
United Kingdom AstraZeneca UK Limited 600 Capability Green
Velika Britanija AstraZeneca UK Limited 600 Capability Green
AstraZeneca S.p.A. Palazzo Volta Via F. Sforza 20080 - Basiglio (Milano) Italy
Sforza 20080 - Basiglio (Milano) Italy
Intravenous use vial (glass)
10 mg/ml otopina za infuziju intravenski bočica (staklo)
(Invented) name
Broj EU odobrenja (Zaštićeno) ime
The recommended dose is one capsule once a day at the same time each day.
Preporučena doza je jedna kapsula jednom dnevno u isto vrijeme svakog dana.
Patients should not use more than one capsule in a day.
Bolesnici ne smiju uzeti više od jedne kapsule dnevno.
The Agency also noted that the fact that the medicine is used once a day may help patients to adhere to their treatment.
Agencija je također smatrala kako će činjenica da se lijek primjenjuje jednom dnevno možda doprinijeti tomu da se bolesnici pridržavaju terapije.
Further information on Seebri Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Više informacija o lijeku Seebri Breezhaler nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
the main measure of effectiveness was improvement in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Glavno mjerilo učinkovitosti u oba ispitivanja bilo je poboljšanje forsiranog izdisajnog volumena bolesnika (FEV1, maksimalni volumen zraka koji osoba može izdahnuti u sekundi).
This helps to keep the airways open and allows the patient to breathe more easily.
To pomaže pri održavanju dišnih putova otvorenima i omogućuje bolesnicima olakšano disanje.
COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.
KOPB je dugotrajna bolest kod koje su dišni putovi i zračne vrećice u plućima oštećeni ili začepljeni, što dovodi do poteškoća pri disanju.
Seebri Breezhaler (glycopyrronium bromide) EMA/326863/2018
Seebri Breezhaler (glikopironijev bromid) EMA/326863/2018
After 12 weeks of treatment, Seebri Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.
U prvom ispitivanju, nakon 12 tjedana terapije lijekom Seebri Breezhaler FEV1 se povećao za 97 ml više nego uz primjenu placeba, a u drugom ispitivanju za 108 ml više.