natgillin/translations-raw huggingface dataset:
There is no relevant use of Seebri Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Nema relevantne primjene Seebri Breezhalera u pedijatrijskoj populaciji (mlađih od 18 godina) u indikaciji KOPB-a.
In clinical studies with Seebri Breezhaler, paradoxical bronchospasm was not observed.
U kliničkim ispitivanjima sa Seebri Breezhalerom nije bio uočen paradoksalni bronhospazam.
There are no data from the use of Seebri Breezhaler in pregnant women.
Nema podataka o primjeni Seebri Breezhaler u trudnica.
The long duration of action can be partly attributed to sustained concentrations of active substance in the lung as reflected by the prolonged terminal elimination half-life of glycopyrronium after inhalation via the Seebri Breezhaler inhaler in contrast to the half life after intravenous administration (see section 5.2).
Dugo trajanje djelovanja djelomično se može pripisati održanim koncentracijama djelatne tvari u plućima što se odražava produljenim terminalnim poluvijekom eliminacije glikopironija nakon inhalacije putem Seebri Breezhaler inhalatora za razliku od poluvijeka nakon intravenske primjene (vidjeti dio 5.2).
No change in mean heart rate or QTc interval was observed with Seebri Breezhaler in doses up to 176 micrograms in COPD patients.
Nije bila uočena nikakva promjena u srednjoj srčanoj frekvenciji ili QTc intervalu sa Seebri Breezhalerom u dozama do 176 mikrograma u bolesnika s KOPB-om.
What Seebri Breezhaler is and what it is used for What you need to know before you use Seebri Breezhaler How to use Seebri Breezhaler Possible side effects
Što je Seebri Breezhaler i za što se koristi Što morate znati prije nego počnete primjenjivati Seebri Breezhaler Kako primjenjivati Seebri Breezhaler Moguće nuspojave
Following oral inhalation using the Seebri Breezhaler inhaler, glycopyrronium was rapidly absorbed and reached peak plasma levels at 5 minutes post dose.
Nakon oralne inhalacije korištenjem Seebri Breezhaler inhalatora, glikopironij se brzo apsorbirao i dosegnuo vršne razine u plazmi 5 minuta nakon doze.
During treatment with Seebri Breezhaler, stop taking this medicine and tell your doctor immediately: - if you experience tightness of the chest, coughing, wheezing or breathlessness immediately after using Seebri Breezhaler (signs of bronchospasm).
Tijekom liječenja Seebri Breezhalerom prestanite primjenjivati ovaj lijek i odmah se obratite liječniku: - ako osjetite stezanje u prsnom košu, kašljanje, piskanje ili nedostatak zraka odmah nakon primjene Seebri Breezhalera (znakovi bronhospazma).
Although no formal drug interaction studies have been performed, Seebri Breezhaler has been used concomitantly with other medicinal products commonly used in the treatment of COPD without clinical evidence of drug interactions.
Iako nisu provedena formalna ispitivanja interakcija među lijekovima, Seebri Breehaler je istodobno primjenjivan s drugim lijekovima koji se često primjenjuju u liječenju KOPB-a bez kliničkog dokaza o interakcijama među lijekovima.
Seebri Breezhaler is recommended to be administered, at the same time of the day each day.
Preporučuje se da se Seebri Breezhaler primjenjuje u isto vrijeme svakoga dana.
Seebri Breezhaler once daily has also shown a statistically significant effect on health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ).
Seebri Breezhaler jedanput na dan također je pokazao statistički značajan učinak na kvalitetu života povezanu sa zdravljem mjerenu korištenjem „St. George“ respiratornog upitnika (eng.
Seebri Breezhaler 44 micrograms once daily provided consistently statistically significant improvement in lung function (forced expiratory volume in one second, FEV1, forced vital capacity, FVC, and inspiratory capacity, IC) in a number of clinical studies.
Seebri Breezhaler 44 mikrograma jedanput na dan omogućio je dosljedno statistički značajno poboljšanje plućne funkcije (forsirani izdisajni volumen u jednoj sekundi, FEV1, forsirani vitalni kapacitet, FVC, i inspiratorni kapacitet, IC) u više kliničkih ispitivanja.
Seebri Breezhaler should be used with caution in these patient groups.
Seebri Breezhaler treba oprezno koristiti u tih skupina bolesnika.
Seebri Breezhaler 44 micrograms once daily can be safely used in all age and body weight groups.
Seebri Breezhaler 44 mikrograma jedanput na dan može se sigurno primjenjivati u svim dobnim skupinama i skupinama prema tjelesnoj težini.
Please read the full Instructions for Use before using the Seebri Breezhaler.
Pročitajte u cijelosti Upute za primjenu prije korištenja Seebri Breezhalera.
The co-administration of Seebri Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended.
Istodobna primjena Seebri Breezhalera s drugim lijekovima koji sadrže antikolinergike nije bila proučavana pa se stoga ne preporučuje.
In a 3-week study where exercise tolerance was tested via cycle ergometer at submaximal (80%) workload (submaximal exercise tolerance test), Seebri Breezhaler, dosed in the morning, reduced dynamic hyperinflation and improved the length of time exercise could be maintained from the first dose onwards.
U 3-tjednom ispitivanju gdje je tolerancija napora bila ispitivana pomoću biciklergometra pri submaksimalnom (80%) opterećenju (submaksimalni test tolerancije napora), Seebri Breezhaler, primijenjen ujutro, smanjio je dinamičku hiperinflaciju i poboljšao duljinu vremena tijekom kojeg se mogao održavati napor od prve doze nadalje.
Talk to your doctor before using Seebri Breezhaler, if any of the following applies to you: - you have kidney problems.
Obratite se svom liječniku prije nego primijenite Seebri Breezhaler, ako se bilo što od navedenoga u nastavku odnosi na Vas: - ako imate tegobe s bubrezima.
Acute intoxication by inadvertent oral ingestion of Seebri Breezhaler capsules is unlikely due to the low oral bioavailability (about 5%).
Akutna intoksikacija slučajnim oralnim unosom kapsula Seebri Breezhaler malo je vjerojatna zbog niske oralne bioraspoloživosti (oko 5%).
This includes medicines similar to Seebri Breezhaler used for your lung disease, such as ipratropium, oxitropium or tiotropium (so called anticholinergics).
To uključuje lijekove koji su slični Seebri Breezhaleru i koriste se za Vašu plućnu bolest, kao što su ipratropij, oksitropij ili tiotropij (takozvani antikolinergici).
The absolute bioavailability of glycopyrromium inhaled via Seebri Breezhaler was estimated to be about 45% of the delivered dose.
Procijenjeno je da je apsolutna bioraspoloživost glikopironija inhaliranog preko Seebri Breezhalera oko 45% isporučene doze.
6 or 10 Seebri Breezhaler capsules to be used in the inhaler
6 ili 10 Seebri Breezhaler kapsula za korištenje u inhalatoru
No specific side effects have been reported when Seebri Breezhaler has been used together with other medicines used to treat COPD such as reliever inhalers (e.g. salbutamol), methylxanthines (e.g. theophylline) and/or oral and inhaled steroids (e.g. prednisolone).
Nisu prijavljene posebne nuspojave kada se Seebri Breezhaler primjenjivao istodobno s drugim lijekovima koji se primjenjuju za liječenje KOPB-a kao što su inhalatori za olakšavanje tegoba (npr. salbutamol), metilksantini (npr. teofilin) i/ili oralni i inhalacijski steroidi (npr. prednizolon).
What Seebri Breezhaler contains - The active substance is glycopyrronium bromide.
Što Seebri Breezhaler sadrži - Djelatna tvar je glikopironijev bromid.
If you use more Seebri Breezhaler than you should If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, you must immediately either tell your doctor or go to the nearest emergency unit.
Ako ste inhalirali previše ovog lijeka ili ako netko zabunom uzme Vaše kapsule, morate odmah obavijestiti svog liječnika ili otići u najbližu hitnu pomoć.
In COPD patients with mild and moderate renal impairment (estimated glomerular filtration rate, eGFR ≥30 ml/min/1.73 m2) Seebri Breezhaler can be used at the recommended dose.
U bolesnika s KOPB-om i s blagim i umjerenim oštećenjem bubrega (procijenjena glomerularna filtracija, eGFR ≥30 ml/min/1,73 m2) Seebri Breezhaler može se koristiti pri preporučenoj dozi.
In the pooled 6-month database the frequency of dry mouth was 2.2% versus 1.1%, of insomnia 1.0% versus 0.8%, and of gastroenteritis 1.4% versus 0.9%, for Seebri Breezhaler and placebo respectively.
U bazi objedinjenih 6-mjesečnih podataka učestalost suhih usta bila je 2,2% naspram 1,1%, nesanice 1,0% naspram 0,8%, te gastroenteritisa 1,4% naspram 0,9% za Seebri Breezhaler odnosno placebo.
Seebri Breezhaler is used as a maintenance treatment for your COPD.
Seebri Breezhaler se koristi kao terapija održavanja za Vaš KOPB.
PA/Alu/PVC - Alu perforated unit-dose blister Packs containing 6x1, 10x1, 12x1 or 30x1 hard capsules, together with one inhaler.
PA/Al/PVC - Aluminijski perforirani blister djeljiv na jedinične doze Pakiranje sadrži 6x1, 10x1, 12x1 ili 30x1 tvrdih kapsula, zajedno s jednim inhalatorom.
Seebri Breezhaler is a once-daily, long-term maintenance treatment and is not indicated for the initial treatment of acute episodes of bronchospasm, i.e. as a rescue therapy.
Seebri Breezhaler je dugoročna terapija održavanja koja se primjenjuje jedanput na dan i nije indiciran za inicijalno liječenje akutnih epizoda bronhospazama, tj. za hitno ublažavanje simptoma.
After three weeks of treatment the improvement in inspiratory capacity with Seebri Breezhaler was similar to the first day (200 ml), exercise endurance time however had increased by 89 seconds (an increase of 21%) compared to placebo.
Nakon tri tjedna liječenja poboljšanje u inspiratornom kapacitetu sa Seebri Breezhalerom bilo je slično onome za prvi dan (200 ml), vrijeme izdržavanja napora se, međutim, povećalo za 89 sekundi (povećanje od 21%) u usporedbi s placebom.
Peak plasma levels and total systemic exposure following intravenous administration of 150 micrograms glycopyrronium bromide (equivalent to 120 micrograms glycopyrronium) in healthy volunteers were respectively about 50-fold and 6-fold higher than the peak and total exposure at steady-state achieved with the recommended dose (44 micrograms once daily) of Seebri Breezhaler and were well tolerated.
Vršne razine u plazmi i ukupna sistemska izloženost nakon primjene u venu 150 mikrograma glikopironijevog bromida (što je ekvivalentno 120 mikrograma glikopironija) u zdravih dobrovoljaca bile su oko 50 odnosno 6 puta više od vršne i ukupne izloženosti u stanju dinamičke ravnoteže postignute uz preporučenu dozu (44 mikrograma jedanput na dan) Seebri Breezhalera i dobro su se podnosile.
Seebri Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Seebri Breezhaler je indiciran kao bronhodilatacijska terapija održavanja za ublažavanje simptoma u odraslih bolesnika s kroničnom opstruktivnom plućnom bolešću (KOPB).
The pooled analysis also showed fewer patients treated with Seebri Breezhaler than with placebo experienced an exacerbation requiring hospitalisation (1.7% versus 4.2%, p=0.003).
Objedinjena analiza također je pokazala da je manje bolesnika liječenih Seebri Breezhalerom nego onih koji su primali placebo doživjelo egzacerbaciju koja je zahtijevala hospitalizaciju (1,7% u usporedbi s 4,2%, p=0,003).
Only use the capsules with the inhaler provided in this pack (Seebri
Koristite kapsule samo uz inhalator priložen u ovom pakiranju (Seebri Breezhaler inhalator).
In patients with severe renal impairment or end-stage renal disease requiring dialysis Seebri Breezhaler should be used only if the expected benefit outweighs the potential risk since the systemic exposure to glycopyrronium may be increased in this population (see sections 4.4 and 5.2).
U bolesnika s teškim oštećenjem bubrega ili bolešću bubrega u završnoj fazi koja zahtijeva dijalizu Seebri Breezhaler smije se koristiti samo ako očekivane koristi premašuju potencijalni rizik obzirom da se u ovoj populaciji može povećati sistemska izloženost glikopironiju (vidjeti dijelove 4.4 i 5.2).
Seebri Breezhaler once daily statistically significantly reduced the use of rescue medication (salbutamol) by 0.46 puffs per day (p=0.005) over 26 weeks and by 0.37 puffs per day (p=0.039) over 52 weeks, compared to placebo for the 6- and 12-month studies, respectively.
Seebri Breezhaler jedanput na dan statistički značajno je smanjio korištenje lijeka za hitno ublažavanje simptoma (salbutamola) za 0,46 udisaja dnevno (p=0,005) tijekom 26 tjedana, odnosno za 0,37 udisaja dnevno (p=0,039) tijekom 52 tjedna, u usporedbi s placeboom za 6-mjesečno odnosno 12-mjesečno ispitivanje.
What Seebri Breezhaler looks like and contents of the pack Seebri Breezhaler 44 micrograms inhalation powder, hard capsules are transparent and orange and contain a white powder.
Kako Seebri Breezhaler izgleda i sadržaj pakiranja Seebri Breezhaler 44 mikrograma prašak inhalata, tvrde kapsule su prozirne i narančaste te sadrže bijeli prašak.
• Do not use the Seebri Breezhaler inhaler to take any other capsule medicine.
• Nemojte koristiti Seebri Breezhaler inhalator za uzimanje kapsula bilo kojeg drugog lijeka.
Seebri Breezhaler should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Seebri Breezhaler treba koristiti oprezno u bolesnika s glaukomom uskog kuta ili urinarnom retencijom.
• One Seebri Breezhaler inhaler
• Jedan Seebri Breezhaler inhalator
Excipient(s) with known effect: Each capsule contains 23.6 mg lactose (as monohydrate).
Svaka kapsula sadrži 23,6 mg laktoze (u obliku hidrata).
In the 6-month study, the percentage of patients experiencing a moderate or severe exacerbation was 17.5% for Seebri Breezhaler and 24.2% for placebo (Hazard ratio: 0.69, p=0.023), and in the 12-month study it was 32.8% for Seebri Breezhaler and 40.2% for placebo (Hazard ratio: 0.66, p=0.001).
U 6-mjesečnom ispitivanju, postotak bolesnika koji su imali umjerenu ili tešku egzacerbaciju bio je 17,5% za Seebri Breezhaler i 24,2% za placebo (omjer rizika: 0,69, p=0,023), a u 12-mjesečnom ispitivanju bio je 32,8% za Seebri Breezhaler i 40,2% za placebo (omjer rizika: 0,66, p=0,001).
Show the pack of Seebri Breezhaler.
Pokažite pakiranje Seebri Breezhalera.
Seebri Breezhaler contains lactose
Seebri Breezhaler sadrži laktozu
In the 12-month study, Seebri Breezhaler produced statistically significant improvements in FEV1 compared to tiotropium in the first 4 hours after dosing on day 1 and at week 26, and numerically greater values for FEV1 in the first 4 hours after dosing than tiotropium at week 12 and week 52.
U 12-mjesečnom ispitivanju, Seebri Breezhaler je doveo do statistički značajna poboljšanja u FEV1 u usporedbi s tiotropijem u prva 4 sata nakon doziranja prvog dana i nakon 26 tjedana, te numerički veće vrijednosti za FEV1 od tiotropija u prva 4 sata nakon doziranja nakon 12 tjedana i nakon 52 tjedna.
Your Seebri Breezhaler Inhaler pack contains:
Vaše pakiranje Seebri Breezhaler inhalatora sadrži:
Seebri Breezhaler 44 micrograms inhalation powder, hard capsules
Seebri Breezhaler 44 mikrograma prašak inhalata, tvrde kapsule
Seebri Breezhaler is a single-dose inhaler.
Seebri Breezhaler je jednodozni inhalator.
• Do not use the Seebri Breezhaler capsules with any other inhaler.
• Nemojte koristiti Seebri Breezhaler kapsule s drugim inhalatorima.
What Seebri Breezhaler is and what it is used for
Što je Seebri Breezhaler i za što se koristi
Seebri Breezhaler also reduced dyspnoea at rest measured using the Transitional Dyspnoea Index.
Seebri Breezhaler je također smanjio dispneju u mirovanju, mjereno korištenjem Prijelaznog indeksa dispneje.
At 12 weeks (primary endpoint), Seebri Breezhaler increased trough FEV1 by 72 ml in patients with the lowest degree of reversibility (<5%) and by 113 ml in those patients with a higher degree of reversibility at baseline (≥5%) compared to placebo (both p<0.05).
Nakon 12 tjedana (primarna mjera ishoda), Seebri Breezhaler povećao je najniži FEV1 za 72 ml u bolesnika s najnižim stupnjem reverzibilnosti (<5%) te za 113 ml u onih bolesnika koji su imali viši stupanj reverzibilnosti na početku (≥5%) u usporedbi s placebom (oba p<0,05).
Instructions for use of Seebri Breezhaler inhaler
Upute za primjenu Seebri Breezhaler inhalatora
In the 6-month study, Seebri Breezhaler increased FEV1 after the first dose with an improvement of 93 ml within 5 minutes and 144 ml within 15 minutes of dosing, compared to placebo (both p<0.001).
6-mjesečnom ispitivanju, Seebri Breezhaler je povećao FEV1 nakon prve doze s poboljšanjem od 93 ml u rok od 5 minuta te 144 ml u roku od 15 minuta od primjene doze, u usporedbi s placebom (oba p<0,001).
Seebri Breezhaler administered at 44 micrograms once daily statistically significantly reduced breathlessness as evaluated by the Transitional Dyspnoea Index (TDI).
Seebri Breezhaler koji se primjenjivao u dozi od 44 mikrograma jedanput na dan statistički značajno je smanjio gubitak daha ocijenjen prema Prijelaznom indeksu dispneje (eng.
Other medicines and Seebri Breezhaler
Drugi lijekovi i Seebri Breezhaler
In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Seebri Breezhaler should be used only if the expected benefit outweighs the potential risk (see section 5.2).
U bolesnika s teškim oštećenjem bubrega (procijenjena glomerularna filtracija manja od 30 ml/min/1,73 m2), uključujući i one s bolešću bubrega u završnoj fazi koja zahtijeva dijalizu, Seebri Breezhaler treba koristiti samo ako očekivana korist premašuje potencijalni rizik (vidjeti dio 5.2).
In patients with severe renal impairment (eGFR <30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Seebri Breezhaler should only be used if the expected benefit outweighs the potential risk (see section 4.4).
U bolesnika s teškim oštećenjem bubrega (eGFR <30 ml/min/1,73 m uključujući one s bolešću bubrega u završnoj fazi koja zahtijeva dijalizu, Seebri Breezhaler treba koristiti samo ako očekivana korist premašuje potencijalni rizik (vidjeti dio 4.4).
In a pooled analysis of the first 6 months of treatment in the 6- and 12-month studies, compared to placebo Seebri Breezhaler statistically significantly prolonged time to first moderate or severe exacerbation and reduced the rate of moderate or severe COPD exacerbations (0.53 exacerbations/year versus 0.77exacerbations /year, p<0.001).
U objedinjenoj analizi prvih 6 mjeseci liječenja u 6- i 12-mjesečnom ispitivanju, u usporedbi s placebom Seebri Breezhaler statistički značajno je produljio vrijeme do prve umjerene ili teške egzacerbacije i smanjio stopu umjerenih ili teških egzacerbacija KOPB-a (0,53 egzacerbacija na godinu u usporedbi s 0,77 egzacerbacija na godinu, p<0,001).
At 12 weeks (primary endpoint), Seebri Breezhaler increased trough FEV1 by 108 ml in the 6-month study and by 97 ml in the 12-month study compared to placebo (both p<0.001).
Nakon 12 tjedana (primarna mjera ishoda), Seebri Breezhaler je povećao najniži FEV1 za 108 ml u 6-mjesečnom ispitivanju te za 97 ml u 12-mjesečnom ispitivanju u usporedbi s placebom (oba p<0,001).
Seebri Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Seebri Breezhaler se može koristiti u preporučenoj dozi u bolesnika s blagim do umjerenim oštećenjem bubrega.
Seebri Breezhaler 44 micrograms inhalation powder, hard capsules glycopyrronium (as glycopyrronium bromide)
Seebri Breezhaler 44 mikrograma prašak inhalata, tvrde kapsule glikopironij (glikopironijev bromid)
Seebri Breezhaler was found to decrease dyspnoea and leg discomfort when exercising as measured using Borg scales.
Uočeno je da Seebri Breezhaler smanjuje dispneju i nelagodu u nogama kod fizičke aktivnosti mjereno korištenjem Borgove skale.
In a pooled analysis of the 6and 12-month pivotal studies a statistically significantly higher percentage of patients receiving Seebri Breezhaler responded with a 1 point or greater improvement in the TDI focal score at week 26 compared to placebo (58.4% and 46.4% respectively, p<0.001).
U objedinjenoj analizi 6- i 12-mjesečnih ključnih ispitivanja statistički značajno viši postotak bolesnika koji su primali Seebri Breezhaler odgovorio je s poboljšanjem od 1 boda ili većim u TDI-u u 26. tjednu u usporedbi s placebom (58,4% odnosno 46,4%, p<0,001).
A pooled analysis of the 6- and 12-month pivotal studies found a statistically significantly higher percentage of patients receiving Seebri Breezhaler responded with a 4 point or greater improvement in SGRQ compared to placebo at week 26 (57.8% and 47.6% respectively, p<0.001).
Objedinjenom analizom 6- i 12-mjesečnih ključnih ispitivanja uočen je u bolesnika koji su primali Seebri Breezhaler statistički značajno viši postotak bolesnika koji su odgovorili s poboljšanjem od 4 boda ili više u SGRQ-u u usporedbi s placebom nakon 26 tjedana (57,8% odnosno 47,6%, p<0,001).
If you forget to inhale a dose, take one as soon as possible.
Ako ste zaboravili primijeniti Seebri Breezhaler Ako zaboravite inhalirati dozu, uzmite je čim bude moguće.
Do not use Seebri Breezhaler - if you are allergic to glycopyrronium bromide or any of the other ingredients of this medicine
Što morate znati prije nego počnete primjenjivati Seebri Breezhaler Nemojte primjenjivati Seebri Breezhaler - ako ste alergični na glikopironijev bromid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
2) Reports have been received from post-approval marketing experience in association with the use of Seebri Breezhaler.
1) Učestalije za glikopironij nego za placebo samo u bazi 12-mjesečnih podataka 2) Dobivena su izvješća iz iskustva nakon stavljanja lijeka u promet, povezana s primjenom Seebri Breezhalera.
Immediate hypersensitivity reactions have been reported after administration of Seebri Breezhaler.
Nakon primjene Seebri Breezhalera zabilježene su neposredne reakcije preosjetljivosti.
How much Seebri Breezhaler to use
Koliko Seebri Breezhalera primjenjivati
What Seebri Breezhaler is
Što je Seebri Breezhaler
What Seebri Breezhaler is used for
Za što se koristi Seebri Breezhaler
Gastroenteritis
Gastroenteritis Mučnina
How to store Seebri Breezhaler
Kako primjenjivati Seebri Breezhaler
Musculoskeletal chest pain
Mišićno-koštana bol u prsištu
• Dry mouth
Nastavak za usta
This damages the bacteria and eventually kills them.
To šteti bakterijama i naposljetku ih ubije.
They also presented data from the published literature.
Podnositelj zahtjeva također je pružio podatke iz objavljene literature.
The trials lasted 24 weeks (three treatment cycles).
Ispitivanja su trajala 24 tjedna (tri ciklusa liječenja).
The recommended dose is four capsules twice a day (as close as possible to 12 hour intervals) for four weeks, followed by four weeks without treatment.
Preporučena doza je četiri kapsule dvaput dnevno (u razmaku od približno 12 sati, koliko je moguće) u razdoblju od četiri tjedna, nakon kojeg slijedi razdoblje od četiri tjedna bez liječenja.
The capsules are only to be inserted into the Podhaler and must never be swallowed.
Kapsule su namijenjene samo umetanju u Podhaler i ni u kom se slučaju ne smiju progutati.
The Committee therefore recommended that it be given marketing authorisation.
Odbor je stoga preporučio izdavanje odobrenja za stavljanje lijeka u promet.
The European Commission granted a marketing authorisation valid throughout the European Union for Tobi Podhaler on 20 July 2011.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Tobi Podhaler na snazi u Europskoj uniji od 20. srpnja 2011.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Tobi Podhaler.
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Tobi Podhaler.