natgillin/translations-raw huggingface dataset:
The terminal elimination half-life of formoterol following oral inhalation derived via population pharmacokinetics analysis was 13 hours.
Prema populacijskoj farmakokinetičkoj analizi, terminalno poluvrijeme eliminacije formoterola nakon peroralne inhalacije iznosilo je 13 sati.
Shake well before use.
Prije uporabe lijek treba dobro protresti.
In three Phase III, 24-week studies (PINNACLE 1, PINNACLE 2 and PINNACLE 4) Bevespi Aerosphere provided improvements over placebo in lung function (as measured by morning pre-dose trough forced expiratory volume in 1 second [FEV1]), with a demonstrated onset of action at 5 minutes following administration of the first dose on Day 1 (improvement over placebo by 187 mL, 186 mL and 179 mL in PINNACLE 1, PINNACLE 2 and PINNACLE 4, respectively [p <0.001]).
forced expiratory volume in 1 second, FEV1] prije primjene jutarnje doze), uz dokazan nastup djelovanja 5 minuta nakon primjene prve doze 1. dana (poboljšanje za 187 ml, 186 ml odnosno 179 ml u odnosu na placebo u ispitivanju PINNACLE 1, PINNACLE 2 odnosno PINNACLE 4 [p <0,001]).
Animal reproduction studies with glycopyrronium have shown reduced rat and rabbit fetal weights, and low body weight gain of rat offspring before weaning was observed at considerably higher systemic exposures than those reached during clinical use.
Ispitivanja učinka glikopironija na reprodukciju životinja pokazala su smanjenu tjelesnu težinu fetusa štakora i kunića kao i smanjeni prirast tjelesne težine mladunčadi štakora prije prestanka sisanja pri razinama sistemske izloženosti značajno većima od onih koje se postižu tijekom kliničke primjene.
INHALER LABEL (PRESSURISED CONTAINER)
NALJEPNICA NA INHALATORU (SPREMNIK POD TLAKOM)
Bevespi Aerosphere also showed improvements in peak FEV1 within 2 hours post-dose over 24 weeks relative to placebo, glycopyrronium and formoterol (p<0.0001) [see Table 2].
Bevespi Aerosphere pokazao je i poboljšanja vršne vrijednosti FEV1 unutar 2 sata nakon primjene doze tijekom 24 tjedna u odnosu na placebo, glikopironij i formoterol (p<0,0001) [vidjeti Tablicu 2].
The inhaler is a pressurised metered dose inhaler, comprising an aluminium pressurised container with an attached dose indicator, supplied with a white plastic actuator body and mouthpiece with an orange dust cap. Each inhaler is individually packaged in a foil laminate pouch containing a desiccant sachet and packed into a carton.
Lijek dolazi u inhalatoru fiksnih doza pod tlakom, koji se sastoji od aluminijskog spremnika pod tlakom s pričvršćenim pokazivačem doze, a isporučuje se zajedno s bijelim plastičnim aktivatorom s nastavkom za usta prekrivenim narančastim zaštitnim zatvaračem.
How to use
Kako primijeniti lijek
This means that there are 110 puffs of medicine left in the pressurised container (See Figure 2b).
To znači da je u spremniku pod tlakom preostala količina lijeka dovoljna za 110 udisaja (pogledajte Sliku 2b).
The estimated formoterol Vc/F (volume of the central compartment), and Vp1/F (volume of the peripheral compartment) are 1030 L, and 647 L, respectively, via population pharmacokinetic analysis.
Na temelju populacijske farmakokinetičke analize, procijenjeni Vc/F (volumen središnjeg odjeljka) formoterola iznosi 1030 l, dok njegov procijenjeni Vp1/F (volumen perifernog odjeljka) iznosi 647 l.
o Take the Bevespi Aerosphere inhaler out of the foil pouch.
o Izvadite inhalator lijeka Bevespi Aerosphere iz vrećice od folije.
This will release a puff of medicine from the mouthpiece (See Figure 5).
Tako ćete iz nastavka za usta otpustiti količinu lijeka za jedan udisaj (pogledajte Sliku 5).
Do not pierce the pressurised container.
Ne probijati spremnik pod tlakom.
No pharmacokinetic studies have been performed with Bevespi Aerosphere in patients with hepatic impairment.
Nisu provedena ispitivanja farmakokinetike lijeka Bevespi Aerosphere kod bolesnika s oštećenjem funkcije jetre.
Immediate breathing difficulties If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using Bevespi Aerosphere: Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.
Prestanite primjenjivati ovaj lijek i odmah potražite liječničku pomoć, jer možda imate ozbiljno stanje koje se zove paradoksalni bronhospazam.
Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension
Bevespi Aerosphere 7,2 mikrograma/5 mikrograma stlačeni inhalat, suspenzija
The mean bronchodilator effect derived from serial FEV1 measurements at Day 1 and Week 12 from PINNACLE 1 are shown in Figure 1.
Na Slici 1 prikazana je srednja vrijednost bronhodilatacijskog učinka, izračunata na temelju vrijednosti FEV1 mjerenog serijski 1. dana i 12. tjedna u ispitivanju PINNACLE 1. Rezultati iz ispitivanja PINNACLE 2 slični su onima opaženima u ispitivanju PINNACLE 1.
Figure 16
Slika 16
This corresponds to a metered dose of glycopyrronium bromide 10.4 micrograms equivalent to 8.3 micrograms of glycopyrronium, and formoterol fumarate dihydrate 5.8 micrograms.
To odgovara odmjernoj dozi od 10,4 mikrograma glikopironijeva bromida, što odgovara količini od 8,3 mikrograma glikopironija, i 5,8 mikrograma formoterolfumarat dihidrata.
Other pharmacodynamic interactions
Druge farmakodinamičke interakcije
Before you use Bevespi Aerosphere for the first time, you must prime the inhaler.
Prije prve primjene lijeka Bevespi Aerosphere morate pripremiti inhalator.
If you have any further questions on the use of this medicine, talk to your doctor or pharmacist.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
The largest mean (90% upper confidence bound) differences from placebo in baseline- and individually corrected QT was 3.1 (4.7) ms for Bevespi Aerosphere (14.4 /10 micrograms) and 7.6 (9.2) ms for glycopyrronium/formoterol with eight times the recommended dose of glycopyrronium and four times the recommended dose of formoterol.
Najveća srednja vrijednost (gornja granica intervala pouzdanosti od 90%) razlike u odnosu na placebo s obzirom na početni ili individualno korigirani QT interval iznosila je 3,1 (4,7) ms uz Bevespi Aerosphere (14,4/10 mikrograma) te 7,6 (9,2) ms uz
Figure 18
Slika 18
This means that there are 100 puffs of medicine left in the pressurised container (See Figure 2c).
To znači da je u spremniku pod tlakom preostala količina lijeka dovoljna za 100 udisaja (pogledajte Sliku 2c).
In patients with severe hepatic impairment, Bevespi Aerosphere should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Kod bolesnika s teškim oštećenjem jetrene funkcije Bevespi Aerosphere smije se primjenjivati samo ako očekivana korist nadmašuje potencijalni rizik (vidjeti dio 5.2).
If you stop using Bevespi Aerosphere
Ako prestanete primjenjivati Bevespi Aerosphere
If you forget to use Bevespi Aerosphere
Ako ste zaboravili primijeniti Bevespi Aerosphere
The other ingredients are norflurane, 1,2- distearoyl-sn-glycero-3-phosphocholine and calcium chloride.
Drugi sastojci su norfluran, 1,2-distearoil-sn-glicero-3-fosfokolin i kalcijev klorid.
Musculoskeletal and connective tissue disorders
Poremećaji mišićno-koštanog sustava i vezivnog tkiva mišićni grčevi često
Norflurane 1,2-distearoyl-sn-glycero-3-phosphocholine and calcium chloride.
Norfluran 1,2-distearoil-sn-glicero-3-fosfokolin i kalcijev klorid.
Agitation Restlessness Insomnia
Psihijatrijski poremećaji anksioznost često agitacija nemir nesanica manje često
• you have an eye problem called narrow-angle glaucoma (also called angle-closure glaucoma)
• ako imate bolest oka koja se zove glaukom uskog kuta (ili glaukom zatvorenog kuta)
How to clean your Bevespi Aerosphere inhaler:
Kako čistiti inhalator lijeka Bevespi Aerosphere:
Clinical drug-drug interaction studies have not been conducted with Bevespi Aerosphere, however, the potential for metabolic interactions is considered to be low based on in-vitro studies (see section 5.2).
Međutim, na temelju podataka iz ispitivanja in vitro, smatra se da je potencijal za metaboličke interakcije malen (vidjeti dio 5.2).
If you find it difficult breathing in and pressing the inhaler at the same time talk to your doctor or pharmacist.
Primjena lijeka Bevespi Aerosphere uz pomoć komore za inhaliranje Ako Vam je teško istodobno udahnuti i pritisnuti inhalator, obratite se svom liječniku ili ljekarniku.
The terminal elimination half-life of glycopyrronium following oral inhalation derived via population pharmacokinetics analysis was 15 hours.
Prema populacijskoj farmakokinetičkoj analizi, terminalno poluvrijeme eliminacije glikopironija nakon peroralne inhalacije iznosilo je 15 sati.
Step 2: Take the cap off the mouthpiece.
2. korak: Skinite zatvarač s nastavka za usta.
• Remove the cap from the mouthpiece (See Figure 3).
• Skinite zatvarač s nastavka za usta (pogledajte Sliku 3).
Figure 15
Slika 15
However, these animal experimental results have little relevance to man. A slight increase in the incidence of uterine leiomyomas has been observed in rats and mice treated with formoterol; an effect which is considered to be a class-effect in rodents after long-term exposure to high doses of β2-adrenoreceptor agonists.
Kod štakora i miševa izloženih formoterolu opaženo je blago povećanje incidencije leiomioma maternice, koje se smatra učinkom skupine kod glodavaca nakon dugotrajnog izlaganja visokim dozama agonista β2-adrenoreceptora.
Bevespi Aerosphere can be used at the recommended dose in patients with mild to moderate hepatic impairment.
Bevespi Aerosphere može se primjenjivati u preporučenoj dozi kod bolesnika s blagim do umjerenim oštećenjem bubrežne funkcije.
The estimated glycopyrronium Vc/F (volume of the central compartment), and Vp1/F (volume of the peripheral compartment) are 741 L, and 2990 L, respectively, via population pharmacokinetic analysis.
Na temelju populacijske farmakokinetičke analize, procijenjeni Vc/F (volumen središnjeg odjeljka) glikopironija iznosi 741 l, dok njegov procijenjeni Vp1/F (volumen perifernog odjeljka) iznosi 2990 l.
number in Intent to Treat population primary endpoint in all studies PINNACLE 1 and PINNACLE 2 used SAC-TDI.
U ispitivanjima PINNACLE 1 i PINNACLE 2 koristio se SAC-TDI.
• Your Bevespi Aerosphere inhaler comes in a foil pouch that contains a drying packet (desiccant).
• Inhalator lijeka Bevespi Aerosphere dolazi u vrećici od folije koja sadrži pakiranje sredstva za sušenje.
• you have prostate problems, or difficulty passing urine
• ako imate tegoba s prostatom ili otežano mokrite
In-vitro glycopyrronium is a substrate for the renal transporters OCT2 and MATE1/2K.
Glikopironij je supstrat bubrežnih prijenosnika OCT2 i MATE1/2K in vitro.
Do not store above 30 oC.
Ne čuvati na temperaturi iznad 30°C.
CYP2D6 was found to be the predominant enzyme involved in the metabolism of glycopyrronium.
Utvrđeno je da u metabolizmu glikopironija pretežno sudjeluje enzim CYP2D6.
Figure 12 Step 8: Replace the cap over the mouthpiece right away after use (See Figure 13).
8. korak: Odmah nakon uporabe vratite zatvarač na nastavak za usta (pogledajte Sliku 13).
Figure 13
Slika 13
• The pointer points between 100 and 120 after you use 10 more puffs.
• Nakon sljedećih 10 udisaja indikator pokazuje između 100 i 120.
Check inside the mouthpiece before you use the inhaler to make sure it is clear.
Prije uporabe inhalatora provjerite da se ništa ne nalazi u nastavku za usta.
In studies PINNACLE 1, PINNACLE 2 and PINNACLE 4, Bevespi Aerosphere showed improvements in trough FEV1 over 24 weeks relative to placebo, glycopyrronium and formoterol (p<0.0001) [see Table 2].
U ispitivanjima PINNACLE 1, PINNACLE 2 i PINNACLE 4 Bevespi Aerosphere pokazao je poboljšanja najniže vrijednosti FEV1 tijekom 24 tjedna u odnosu na placebo, glikopironij i formoterol (p<0,0001) [vidjeti Tablicu 2]. Bronhodilatacijski učinak nije oslabio tijekom vremena.
120 actuations
120 potisaka
SAC-TDI was a primary endpoint in PINNACLE 1 and PINNACLE 2 only From the Rescue Ventolin User Population in PINNACLE 4 A hierarchical statistical testing procedure was used in this study and this comparison was below a comparison that did not achieve statistical significance.
SAC-TDI rezultat bio je primarna mjera ishoda samo u ispitivanjima PINNACLE 1 i PINNACLE 2 Podaci prikupljeni u populaciji bolesnika iz ispitivanja PINNACLE 4 koji su primjenjivali Ventolin za hitno ublažavanje simptoma
Gastrointestinal disorders Dry mouth 2, Nausea
Poremećaji probavnog sustava suha usta
Figure 11
Slika 11
Aerosphere (N=551) vs placebo (N=235)
Aerosphere (N=551) u odnosu na placebo (N=235)
Mouthpiece
• mučnina
The pharmacokinetics of formoterol was best described by a two compartment disposition model with a first-order rate constant of absorption and linear elimination.The typical clearance (CL/F) of formoterol was 99 L/h.
Farmakokinetika formoterola najbolje je opisana modelom raspoloživosti s dva odjeljka, s konstantom apsorpcije prvog reda i linearnom eliminacijom.
Aerosphere (N=526) vs placebo (N=219)
Aerosphere (N=526) u odnosu na placebo (N=219)
Aerosphere (N=510) vs placebo (N=223)
Aerosphere (N=510) u odnosu na placebo (N=223)
Bevespi Aerosphere is for inhalation use.
Bevespi Aerosphere primjenjuje se udisanjem (inhaliranjem).
Each single puff delivers a dose of 9 micrograms glycopyrronium bromide (equivalent to 7.2 micrograms of glycopyrronium), and 5 micrograms of formoterol fumarate dihydrate.
Jednim udisajem isporučuje se doza od 9 mikrograma glikopironijeva bromida (što odgovara količini od 7,2 mikrograma glikopironija) i 5 mikrograma formoterolfumarat dihidrata.
The effect of renal impairment on the exposure to glycopyrronium and formoterol for up to 12 weeks was evaluated in a population pharmacokinetic analysis.
U populacijskoj farmakokinetičkoj analizi ocjenjivao se utjecaj oštećenja funkcije bubrega na izloženost glikopironiju i formoterolu tijekom razdoblja u trajanju do 12 tjedana.
Bevespi Aerosphere (N=551) vs glycopyrronium (N=474)
Bevespi Aerosphere (N=551) u odnosu na glikopironij (N=474)
The active substances are glycopyrronium and formoterol fumarate dihydrate.
Što Bevespi Aerosphere sadrži Djelatne tvari su glikopironij i formoterolfumarat dihidrat.
Bevespi Aerosphere, 7.2 micrograms / 5 micrograms pressurised inhalation, suspension glycopyrronium / formoterol fumarate dihydrate
Bevespi Aerosphere 7,2 mikrograma/5 mikrograma stlačeni inhalat, suspenzija glikopironij/formoterolfumarat dihidrat
The mouthpiece is covered with an orange protective cap. Bevespi Aerosphere is supplied in a foil pouch that contains a drying packet (desiccant) and packed into a carton.
Bevespi Aerosphere isporučuje se u vrećici od folije, koja sadrži vrećicu sa sredstvom za sušenje, i dolazi zapakiran u kutiji.
Dose indicator
Pokazivač doze
In PINNACLE 1, PINNACLE 2 and PINNACLE 4, Bevespi Aerosphere provided an improvement in disease-specific health-related quality of life, as indicated by a reduction in the St George's Respiratory Questionnaire (SGRQ) total score over 24 weeks compared to placebo and glycopyrronium [see Table 2].
U ispitivanjima PINNACLE 1, PINNACLE 2 i PINNACLE 4 Bevespi Aerosphere ostvario je poboljšanje kvalitete života vezane uz zdravlje specifične za ovu bolest, što je pokazalo smanjenje ukupnog rezultata upitnika o bolestima dišnih putova „St. George's“ (engl.
Each single actuation (delivered dose, ex-actuator) contains glycopyrronium bromide 9 micrograms equivalent to 7.2 micrograms of glycopyrronium, and 5 micrograms of formoterol fumarate dihydrate.
Jednim potiskom primjenjuje se doza (isporučena doza, doza oslobođena iz aktivatora) koja sadrži 9 mikrograma glikopironijeva bromida, što odgovara količini od 7,2 mikrograma glikopironija, i 5 mikrograma formoterolfumarat dihidrata.
On actuation of Bevespi Aerosphere, a volume of the suspension is expelled from the pressurised container at high velocity.
Aktivacijom inhalatora lijeka Bevespi Aerosphere iz spremnika pod tlakom velikom se brzinom oslobađa određeni volumen suspenzije.
SIDE VIEW
BOČNI PRIKAZ
NAMES OF THE MARKETING AUTHORISATION HOLDER
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
How to store Bevespi Aerosphere
Kako čuvati Bevespi Aerosphere
Bevespi Aerosphere (N=551) vs formoterol fumarate (N=480)
Aerosphere (N=551) u odnosu na formoterolfumarat (N=480)
How to use Bevespi Aerosphere
Kako primjenjivati Bevespi Aerosphere
Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including glycopyrronium or formoterol.
Nakon primjene antagonista muskarinskih receptora i simpatomimetika, uključujući glikopironij ili formoterol, mogu nastupiti kardiovaskularni učinci poput srčanih aritmija, npr. fibrilacije atrija i tahikardije.
Pointer
Indikator
Priming your Bevespi Aerosphere inhaler:
Priprema inhalatora lijeka Bevespi Aerosphere:
Bevespi Aerosphere (N=526) vs formoterol fumarate (N=449)
Aerosphere (N=526) u odnosu na formoterolfumarat (N=449)
Bevespi Aerosphere (N=510) vs formoterol fumarate (N=437)
Aerosphere (N=510) u odnosu na formoterolfumarat (N=437)
• you have thyroid gland problems (called ‘thyrotoxicosis')
• ako imate tegoba sa štitnjačom (tireotoksikozu)
Do not clean the pressurised container or let it get wet.
Nemojte čistiti ni močiti spremnik pod tlakom.
Bevespi Aerosphere 7.2 mcg/5 mcg pressurised inhalation glycopyrronium/formoterol fumarate dihydrate Inhalation use
Bevespi Aerosphere 7,2 μg/5 μg stlačeni inhalat glikopironij/formoterolfumarat dihidrat
FOIL POUCH
• suha usta
6.1 List of excipients
6.1 Popis pomoćnih tvari norfluran
Shake the inhaler well before each priming puff.
Prije svakog otpuštanja lijeka radi pripreme inhalatora dobro protresite inhalator.
Glycopyrronium
Blokatori β-adrenoreceptora
In PINNACLE 1 and PINNACLE 2, Bevespi Aerosphere provided improvements in breathlessness as demonstrated by Self-administered Computerised Transitional Dyspnoea Index (SAC TDI) focal score over 24 weeks compared to placebo and glycopyrronium (see Table 2).
Self-administered Computerised Transitional Dyspnoea Index, SAC TDI) tijekom 24 tjedna u usporedbi s placebom i glikopironijem (vidjeti Tablicu 2).
Drug-induced hypokalaemia
Hipokalijemija uzrokovana djelovanjem lijeka
A puff of medicine is released each time you press the centre of the dose indicator.
Svakim pritiskom na središnji dio pokazivača doze oslobađa se količina lijeka za jedan udisaj.
• The pointer points to 100 after you take 10 more puffs.
• Nakon sljedećih 10 udisaja indikator pokazuje 100.
Anxiety
Doziranje
Each single actuation contains glycopyrronium bromide equivalent to 7.2 micrograms of glycopyrronium, and 5 micrograms of formoterol fumarate dihydrate.
Jednim potiskom primjenjuje se glikopironijev bromid u dozi koja odgovara 7,2 mikrograma glikopironija te 5 mikrograma formoterolfumarat dihidrata.
Norflurane
Glikopironij
This means that there are 120 puffs of medicine left in the pressurised container (See Figure 2a).
120 udisaja (pogledajte Sliku 2a).
• dry mouth
Nastavak za usta
Do not use Bevespi Aerosphere if:
Nemojte primjenjivati Bevespi Aerosphere
• anxiety
• nemir
In PINNACLE 4, Bevespi Aerosphere provided improvements in breathlessness as demonstrated by TDI focal score over 24 weeks compared to placebo and glycopyrronium (see Table 2).
Transition Dyspnoea Index, TDI) tijekom 24 tjedna u usporedbi s placebom i glikopironijem (vidjeti Tablicu 2).
COPD exacerbations:
Egzacerbacije KOPB-a:
• Talk to your doctor or pharmacist if you have any questions about the use of your inhaler.
• Ako imate bilo kakvih pitanja o uporabi inhalatora, obratite se liječniku ili ljekarniku.
Table 1Adverse reactions by frequency and system organ class (SOC)
Nuspojave prema učestalosti i klasifikaciji organskih sustava Klasifikacija organskih sustava
Common conditions adverse reaction relates to formoterol adverse reaction relates to glycopyrronium
Opći poremećaji i reakcije na mjestu primjene bol u prsištu često nuspojava povezana s formoterolom nuspojava povezana s glikopironijem
The recommended dose is:
Preporučena doza jest:
Menstruation is no contraindication.
Menstruacija nije kontraindikacija.
After first opening: use within 45 days.
Nakon prvog otvaranja: upotrijebiti u roku od 45 dana.
No further interaction studies have been performed.
Nisu provedena daljnja ispitivanja interakcija.
Date of first authorisation: 2 June 2017
Datum prvog odobrenja: 02. lipnja 2017.
In such situations, treatment cessation should be considered.
U tim situacijama potrebno je razmotriti prekid liječenja.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Pažljivo pročitajte ovu uputu prije nego što počnete uzimati ovaj lijek jer sadrži Vama važne podatke.
Your doctor will discuss with you whether the treatment should be continued.
Liječnik će s Vama razgovarati o tome trebate li nastaviti s liječenjem.
• ringing or buzzing in the ears
• zvonjenje ili zujanje u ušima
In three studies, the observed difference was clearly statistically significant.
U trima ispitivanjima primijećena razlika bila je jasno statistički značajna.
This leaflet was last revised in <{MM/YYYY}>.
Ova uputa zadnji je put revidirana: <{MM/YYYY}>.
Not known: frequency cannot be estimated from the available data
Nepoznato: učestalost se ne može procijeniti na temelju dostupnih podataka
Keep the bottle tightly closed in order to protect from moisture.
Držite bočicu čvrsto zatvorenom radi zaštite od vlage.
Open date: ……………………
Datum otvaranja: ……………………
The capsules should be taken with water at least 1 hour before meals or 2 hours after meals.
Kapsule treba uzimati s vodom najmanje 1 sat prije obroka ili 2 sata nakon obroka.
In addition positive effects were observed on the voiding profile, although the observed differences were not statistically significant:
Osim toga, primijećeni su pozitivni učinci na profil mokrenja, iako primijećene razlike nisu bile statistički značajne:
Always take this medicine exactly as your doctor or pharmacist has told you.
Uvijek uzmite ovaj lijek točno onako kako vam je savjetovao vaš liječnik ili ljekarnik.
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Vrlo često (≥1/10), često (≥1/100 i < 1/10), manje često (≥1/1000 i < 1/100), rijetko (≥1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Take the capsules whole with one glass of water, at least 1 hour before or 2 hours after meals.
Uzmite cijelu kapsulu s jednom čašom vode barem 1 sat prije ili 2 sata nakon obroka.
For storage conditions after first opening of the bottle, see section 6.3.
Uvjete čuvanja nakon prvog otvaranja bočice vidjeti u dijelu 6.3.
• allergic reactions, increased sensitivity to light
• alergijske reakcije, povećana osjetljivost na svjetlo
PVC/Aclar-Aluminium blister with 90 (9x10) capsules.
PVC/Aclar-aluminijski blister s 90 (9 x 10) kapsula.
GRA (95% CI) Pain (95% CI) Urgency (95% CI)
(95 % CI) Urgencija (95 % CI)
• The other ingredients are microcrystalline cellulose, magnesium stearate, gelatin, titanium dioxide (E171).
• Drugi sastojci su mikrokristalična celuloza, magnezijev stearat, želatina, titanijev dioksid (E171).
• ever had a reduced number of blood platelets caused by the medicine called heparin
• ste ikad imali smanjen broj trombocita uzrokovan lijekom koji se zove heparin
Participants who reported either of the latter two categories were defined as treatment responders.
Ispitanici koji su prijavili bilo koju od zadnje dvije kategorije definirani su kao ispitanici koji odgovaraju na liječenje.
Other medicines and elmiron
Drugi lijekovi i elmiron
Dispose any remaining capsules after this period.
Nakon tog razdoblja bacite sve preostale kapsule.
Talk to your doctor or pharmacist before taking elmiron if you have:
Obratite se svom liječniku ili ljekarniku prije nego što uzmete lijek elmiron ako:
White opaque capsules size 2.
Bijele neprozirne kapsule veličine 2.
• lack of blood platelets, red or white blood cells
• manjak trombocita, crvenih ili bijelih krvnih stanica