natgillin/translations-raw huggingface dataset:
Some elderly patients above 75 years of age experienced headache (frequency common) and urinary tract infection (frequency common).
Neki stariji bolesnici iznad dobi od 75 godina osjetili su glavobolju (kategorija učestalosti često) i infekcije mokraćnog trakta (kategorija učestalosti često).
• Stomach discomfort after meals
• Nelagoda u želucu nakon obroka
How long to continue your treatment with Tovanor Breezhaler - Keep using this medicine for as long as your doctor tells you.
Koliko dugo nastaviti liječenje Tovanor Breezhalerom - Nastavite primijenjivati ovaj lijek dokle god Vam liječnik kaže.
Gastrointestinal effects including gastroenteritis and dyspepsia were also observed.
Gastrointestinalni učinci koji su uključivali gastroenteritis i dispepsiju također su bili uočeni.
Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Tovanor Breezhaler and to contact their doctor immediately should any of these signs or symptoms develop.
Bolesnike treba obavijestiti o znakovima i simptomima akutnog glaukoma uskog kuta i uputiti ih da prestanu koristiti Tovanor Breezhaler te da se odmah obrate svom liječniku ako se pojavi bilo koji od tih znakova i simptoma.
How to inhale Tovanor Breezhaler - In this pack, you will find an inhaler and capsules (in blisters) that contain the medicine as inhalation powder.
Kako inhalirati Tovanor Breezhaler - U ovom pakiranju naći ćete inhalator i kapsule (u blisterima) koji sadrže lijek kao prašak inhalata.
The capsules must be administered only using the Tovanor Breezhaler inhaler (see section 6.6).
Kapsule se moraju primjenjivati isključivo korištenjem Tovanor Breezhaler inhalatora (vidjeti dio 6.6).
There is no relevant use of Tovanor Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Nema relevantne primjene Tovanor Breezhalera u pedijatrijskoj populaciji (mlađih od 18 godina) u indikaciji KOPB-a.
A greater than 4-fold selectivity for the human M3 receptors over the human M2 receptor has been demonstrated using radioligand binding studies.
Dokazana je selektivnost za humane M3 receptore koja je više od 4 puta veća od one za humani M2 receptor u ispitivanjima vezanja radioaktivnog liganda.
Cardiac disorders Atrial fibrillation
Srčani poremećaji Fibrilacija atrija
The recommended dose is the inhalation of the content of one capsule once daily using the Tovanor Breezhaler inhaler.
Preporučena doza je inhalacija sadržaja jedne kapsule jedanput na dan korištenjem Tovanor Breezhaler inhalatora.
If signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips, and face), urticaria or skin rash, treatment should be discontinued immediately and alternative therapy instituted.
Ako se pojave znakovi koji upućuju na alergijske reakcije, osobito angioedem (uključujući poteškoće u disanju ili gutanju, oticanje jezika, usana i lica), urtikarija ili kožni osip, liječenje treba odmah prekinuti i započeti alternativnu terapiju.
Glucuronide and/or sulfate conjugates of glycopyrronium were found in urine of humans after repeated inhalation, accounting for about 3% of the dose.
Glukuronid i/ili sulfatni konjugati glikopironija bili su pronađeni u mokraći ljudi nakon opetovane inhalacije, što je predstavljalo oko 3% doze.
The European Medicines Agency has waived the obligation to submit the results of studies with Tovanor Breezhaler in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Tovanor Breezhaler u svim podskupinama pedijatrijske populacije u KOPB-u (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
There was no attenuation of the bronchodilator effect over time in the 6and 12-month studies.
Nije bilo slabljenja bronhodilatacijskog učinka tijekom vremena u 6i 12-mjesečnim ispitivanjima.
Insufficient pharmacokinetic data is available for other ethnicities or races.
Raspoloživi farmakokinetički podaci za osobe drugih etničkih pripadnosti ili rasa nisu dostatni.
However, glycopyrronium bromide (including its metabolites) was excreted in the milk of lactating rats (see section 5.3).
Međutim, gikopironijev bromid (što uključuje i njegove metabolite) izlučivao se u mlijeko štakora u laktaciji (vidjeti dio 5.3).
The values for FEV1 at the end of the dosing interval (24 h post dose) were similar between the first dose and those seen after 1 year of dosing.
Vrijednosti za FEV1 na kraju intervala doziranja (24 h nakon doze) bile su slične između prve doze i onih uočenih nakon 1 godine doziranja.
• Tovanor Breezhaler capsules must always be stored in the blister card and only removed immediately before use.
• Tovanor Breezhaler kapsule moraju se uvijek čuvati u blister kartici i izvaditi tek neposredno prije primjene.
Renal elimination of parent drug accounts for about 60 to 70% of total clearance of systemically available glycopyrronium whereas non-renal clearance processes account for about 30 to 40%.
Bubrežna elimnacija ishodišnog lijeka predstavlja oko 60 do 70% ukupnog klirensa sistemski raspoloživog glikopironija dok procesi nebubrežnog klirensa predstavljaju oko 30 do 40%.
- When you start a new pack, use the new Tovanor Breezhaler inhaler that is supplied in the pack.
- Kada otvorite novo pakiranje, upotrijebite novi Tovanor Breezhaler inhalator koji je priložen u pakiranju.
In clinical studies with Tovanor Breezhaler, paradoxical bronchospasm was not observed.
U kliničkim ispitivanjima sa Tovanor Breezhalerom nije bio uočen paradoksalni bronhospazam.
There were no major differences in total systemic exposure (AUC) between Japanese and Caucasian subjects following inhalation of glycopyrronium bromide.
Nije bilo većih razlika u ukupnoj sistemskoj izloženosti (AUC) između ispitanika Japanaca i bijelaca nakon inhalacije glikopironijevog bromida.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
• One or more blister cards, each containing either 6 or 10 Seebri Breezhaler capsules to be used in the inhaler
• Jednu ili više blister kartica, od kojih svaka sadrži 6 ili 10 Tovanor Breezhaler kapsula za korištenje u inhalatoru
There are no data from the use of Tovanor Breezhaler in pregnant women.
Nema podataka o primjeni Tovanor Breezhaler u trudnica.
• Pain in arms or legs
• Bol u rukama ili nogama
Based on the magnitude of these changes, no clinically relevant drug interaction is expected when glycopyrronium is co-administered with cimetidine or other inhibitors of organic cation transport.
Na temelju opsega tih promjena, ne očekuje se nikakva klinički relevantna interakcija kada se glikopironij primjenjuje istodobno s cimetidinom ili drugim inhibitorima transporta organskih kationa.
What Tovanor Breezhaler is and what it is used for What you need to know before you use Tovanor Breezhaler How to use Tovanor Breezhaler Possible side effects
Što je Tovanor Breezhaler i za što se koristi Što morate znati prije nego počnete primjenjivati Tovanor Breezhaler Kako primjenjivati Tovanor Breezhaler Moguće nuspojave
It has a rapid onset of action as evidenced by observed receptor association/dissociation kinetic parameters and the onset of action after inhalation in clinical studies.
Ima brzi nastup djelovanja što je vidljivo iz uočenih kinetičkih parametara otpuštanja/vezanja za receptor i nastupa djelovanja nakon inhalacije u kliničkim ispitivanjima.
Tovanor 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).
Tovanor Breezhaler jedanput na dan također je pokazao statistički značajan učinak na kvalitetu života povezanu sa zdravljem mjerenu korištenjem „St. George“ respiratornog upitnika (eng.
Infections and infestations Nasopharyngitis
Infekcije i infestacije Nazofaringitis
Glycopyrronium should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.
Glikopironij se smije koristiti tijekom trudnoće samo ako očekivana korist opravdava potencijalni rizik za fetus.
Tovanor Breezhaler should be used with caution in these patient groups.
Tovanor Breezhaler treba oprezno koristiti u tih skupina bolesnika.
Tovanor Breezhaler is recommended to be administered, at the same time of the day each day.
Preporučuje se da se Tovanor Breezhaler primjenjuje u isto vrijeme svakoga dana.
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 Tovanor 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 Tovanor Breezhaler inhalatora za razliku od poluvijeka nakon intravenske primjene (vidjeti dio 5.2).
The use of glycopyrronium by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant (see section 5.3).
Primjenu glikopironija u dojilja treba uzeti u obzir samo ako je očekivana korist za ženu veća od bilo kojeg mogućeg rizika za dojenče (vidjeti dio 5.3).
In vitro metabolism studies showed consistent metabolic pathways for glycopyrronium bromide between animals and humans.
In vitro ispitivanja metabolizma pokazala su dosljedne metaboličke putove za glikopironijev bromid između životinja i ljudi.
Following oral inhalation using the Tovanor Breezhaler inhaler, glycopyrronium was rapidly absorbed and reached peak plasma levels at 5 minutes post dose.
Nakon oralne inhalacije korištenjem Tovanor Breezhaler inhalatora, glikopironij se brzo apsorbirao i dosegnuo vršne razine u plazmi 5 minuta nakon doze.
They have the product code “GPL50” printed in black above and a company logo ( ) printed in black below a black bar.
Imaju šifru proizvoda „GPL50“ otisnutu crnom bojom iznad te logotip tvrtke ( ) otisnut crnom bojom ispod crne crte.
Parasympathetic nerves are the major bronchoconstrictive neural pathway in airways, and cholinergic tone is the key reversible component of airflow obstruction in COPD.
Parasimpatički živci su glavni bronhokonstriktivni neuralni put u dišnim putovima, a kolinergički tonus je ključna reverzibilna komponenta otežanog prolaza zraka u KOPB-u.
During treatment with Tovanor Breezhaler, stop taking this medicine and tell your doctor immediately: - if you experience tightness of the chest, coughing, wheezing or breathlessness immediately after using Tovanor Breezhaler (signs of bronchospasm).
Tijekom liječenja Tovanor Breezhalerom prestanite primjenjivati ovaj lijek i odmah se obratite liječniku: - ako osjetite stezanje u prsnom košu, kašljanje, piskanje ili nedostatak zraka odmah nakon primjene Tovanor Breezhalera (znakovi bronhospazma).
Adverse reactions related to local tolerability included throat irritation, nasopharyngitis, rhinitis and sinusitis.
Nuspojave povezane s lokalnom podnošljivošću uključivale su nadražaj grla, nazofaringitis, rinitis i sinusitis.
In phase III studies, bronchodilator effects were seen within 5 minutes after the first dose and were maintained over the 24-hour dosing interval from the first dose.
U ispitivanjima faze III, bronhodilatacijski učinci bili su uočeni u roku od 5 minuta od prve doze te održani tijekom 24-satnog intervala doziranja od prve doze.
A slight reduction in heart rate (mean difference over 24 h -2 bpm when compared to placebo), which is a known effect of low exposures to anticholinergic compounds in young healthy subjects, was observed.
Bilo je uočeno blago smanjenje srčane frekvencije (srednja razlika tijekom 24 h -2 bpm u usporedbi s placebom), što je poznati učinak niskih izloženosti antikolinergičkim spojevima u zdravih ispitanika.
No change in mean heart rate or QTc interval was observed with Tovanor Breezhaler in doses up to 176 micrograms in COPD patients.
Nije bila uočena nikakva promjena u srednjoj srčanoj frekvenciji ili QTc intervalu sa Tovanor Breezhalerom u dozama do 176 mikrograma u bolesnika s KOPB-om.
Tovanor Breezhaler 44 micrograms once daily can be safely used in all age and body weight groups.
Tovanor Breezhaler 44 mikrograma jedanput na dan može se sigurno primjenjivati u svim dobnim skupinama i skupinama prema tjelesnoj težini.
Glycopyrronium has no or negligible influence on the ability to drive and use machines.
Glikopironij ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Although no formal drug interaction studies have been performed, Tovanor 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, Tovanor Breehaler je istodobno primjenjivan s drugim lijekovima koji se često primjenjuju u liječenju KOPB-a bez kliničkog dokaza o interakcijama među lijekovima.
These include sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids.
Oni uključuju simpatomimetičke bronhodilatatore, metilksantine i oralne i inhalacijske steroide.
Tovanor 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.
Tovanor 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.
It is unknown whether glycopyrronium bromide is excreted in human milk.
Nije poznato izlučuje li se glikopironijev bromid u majčino mlijeko u ljudi.
Driving and using machines It is unlikely that this medicine will affect your ability to drive and use machines.
Malo je vjerojatno da će ovaj lijek utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
The elimination pattern suggests sustained lung absorption and/or transfer of glycopyrronium into the systemic circulation at and beyond 24 hours after inhalation.
Način eliminacije ukazuje na održanu plućnu apsorpciju i/ili prijenos glikopironija u sistemsku cirkulaciju u trenutku 24 sata od inhalacije i nakon toga.
Please read the full Instructions for Use before using the Tovanor Breezhaler.
Pročitajte u cijelosti Upute za primjenu prije korištenja Tovanor Breezhalera.
3H]-labelled glycopyrronium bromide to humans, the mean urinary excretion of radioactivity in 48 hours amounted to 85% of the dose.
3H] u venu u ljudi, srednje urinarno izlučivanje radioaktivnosti u 48 sati iznosilo je 85% doze.
Patients with unstable ischaemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation), a history of long QT syndrome or whose QTc (Fridericia method) was prolonged (>450 ms for males or >470 ms for females) were excluded from the clinical trials, and therefore the experience in these patient groups is limited.
Bolesnici s nestabilnom ishemijskom bolešću srca, zatajivanjem lijeve klijetke, anamnezom infarkta miokarda, aritmijom (isključujući kroničnu stabilnu fibrilaciju atrija), anamnezom sindroma dugog QT intervala ili bolesnici čiji je QTc (Fridericijina metoda) bio produljen (>450 ms za muškarce ili >470 ms za žene) bili su isključeni iz kliničkih ispitivanja pa je stoga iskustvo u tim skupinama bolesnika ograničeno.
The co-administration of Tovanor Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended.
Istodobna primjena Tovanor Breezhalera s drugim lijekovima koji sadrže antikolinergike nije bila proučavana pa se stoga ne preporučuje.
This includes medicines similar to Tovanor Breezhaler used for your lung disease, such as ipratropium, oxitropium or tiotropium (so called anticholinergics).
To uključuje lijekove koji su slični Tovanor Breezhaleru i koriste se za Vašu plućnu bolest, kao što su ipratropij, oksitropij ili tiotropij (takozvani antikolinergici).
Adverse reactions reported during the first six months of two pooled pivotal Phase III trials of 6 and 12 months duration are listed by MedDRA system organ class (Table 1).
Nuspojave prijavljene tijekom prvih šest mjeseci dvaju objedinjenih ključnih ispitivanja faze III trajanja od 6 odnosno 12 mjeseci navedene su prema MedDRA klasifikaciji organskih sustava (Tablica 1).
If you use more Tovanor 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.
- The other ingredients of the inhalation powder are lactose monohydrate and magnesium stearate.
- Drugi sastojci praška inhalata su laktoza hidrat i magnezijev stearat.
• Difficulty and pain when passing urine
• Poteškoće i bol kod mokrenja
COPD exacerbation data was collected in the 6- and 12-month pivotal studies.
Podaci o egzacerbaciji KOPB-a prikupljeni su iz 6- i 12-mjesečnih ključnih ipitivanja.
Talk to your doctor before using Tovanor Breezhaler, if any of the following applies to you: - you have kidney problems.
Obratite se svom liječniku prije nego primijenite Tovanor Breezhaler, ako se bilo što od navedenoga u nastavku odnosi na Vas: - ako imate tegobe s bubrezima.
In a 3-week study where exercise tolerance was tested via cycle ergometer at submaximal (80%) workload (submaximal exercise tolerance test), Tovanor 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), Tovanor Breezhaler, primijenjen ujutro, smanjio je dinamičku hiperinflaciju i poboljšao duljinu vremena tijekom kojeg se mogao održavati napor od prve doze nadalje.
In the 12-month study, the improvement versus placebo for tiotropium was 83 ml (p<0.001).
U 12-mjesečnom ispitivanju, poboljšanje u odnosu na placebo za tiotropij bilo je 83 ml (p<0,001).
Concomitant administration of glycopyrronium and orally inhaled indacaterol, a beta2-adrenergic agonist, under steady-state conditions of both active substances did not affect the pharmacokinetics of either medicinal product.
Istodobna primjena glikopironija i oralno inhaliranog indakaterola, beta2-adrenergičkog agonista, u stanju dinamičke ravnoteže obje djelatne tvari nije utjecala na farmakokinetiku ni jednog ni drugog lijeka.
• Pain in muscles, bones or joints of the chest
• Bol u mišićima, kostima ili zglobovima prsnog koša
The clinical Phase III development programme included two phase III studies: a 6-month placebo-controlled study and a 12-month placebo and active-controlled (open label tiotropium 18 micrograms once daily) study, both in patients with clinical diagnosis of moderate to severe COPD.
Klinički razvojni program faze III uključivao je dva ispitivanja faze III: 6-mjesečno placebom kontrolirano ispitivanje te 12-mjesečno placebom i aktivno kontrolirano (nemaskirani tiotropij 18 mikrograma jedanput na dan) ispitivanje, oba provedena u bolesnika s kliničkom dijagnozom umjerenog do teškog KOPB-a.
In vitro enzyme induction studies did not indicate a clinically relevant induction by glycopyrronium bromide for cytochrome P450 isoenzymes, or for UGT1A1 and the transporters MDR1 and MRP2.
In vitro ispitivanja indukcije enzima nisu ukazala na klinički relevantnu indukciju glikopironijevim bromidom za izoenzime citokroma P450, ili za UGT1A1 i transportere MDR1 i MRP2.
In a clinical study in healthy volunteers, cimetidine, an inhibitor of organic cation transport which is thought to contribute to the renal excretion of glycopyrronium, increased total exposure (AUC) to glycopyrronium by 22% and decreased renal clearance by 23%.
U kliničkom ispitivanju u zdravih dobrovoljaca, cimetidin, inhibitor transporta organskih kationa za koji se vjeruje da doprinosi izlučivanju glikopironija putem bubrega, povećao je ukupnu izloženost (AUC) glikopironiju za 22% te smanjio bubrežni klirens za 23%.
Carcinogenicity studies in transgenic mice using oral administration and in rats using inhalation administration revealed no evidence of carcinogenicity at systemic exposures (AUC) of approximately 53-fold higher in mice and 75-fold higher in rats than the maximum recommended dose of 44 micrograms once daily for humans.
Ispitivanja karcinogenosti u transgenih miševa korištenjem oralne primjene te u štakora korištenjem inhalacijske primjene nije otkrilo nikakve dokaze karcinogenosti pri sistemskim izloženostima (AUC) koje su bile otprilike 53 puta više u miševa i 75 puta više u štakora od maksimalne preporučene doze od 44 mikrograma jedanput na dan za ljude.
In COPD the muscles around the airways tighten.
Kod KOPB-a mišići oko dišnih putova se stežu.
Acute intoxication by inadvertent oral ingestion of Tovanor Breezhaler capsules is unlikely due to the low oral bioavailability (about 5%).
Akutna intoksikacija slučajnim oralnim unosom kapsula Tovanor Breezhaler malo je vjerojatna zbog niske oralne bioraspoloživosti (oko 5%).
6 x 1 capsules + 1 inhaler 10 x 1 capsules + 1 inhaler 12 x 1 capsules + 1 inhaler 30 x 1 capsules + 1 inhaler
6 x 1 kapsula + 1 inhalator 10 x 1 kapsula + 1 inhalator 12 x 1 kapsula + 1 inhalator 30 x 1 kapsula + 1 inhalator
The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP) , koji se nalazi u Modulu 1.8.2
• Rash, itching, hives, difficulty breathing or swallowing, dizziness (possible signs of allergic reaction)
• Osip, svrbež, koprivnjača, poteškoće u disanju ili gutanju, omaglica (mogući znakovi alergijske reakcije)
INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
SEKUNDARNA KUTIJA U VIŠESTRUKOM PAKIRANJU (BEZ PLAVOG OKVIRA)
On the first day of treatment inspiratory capacity under exercise was improved by 230 ml and exercise endurance time was improved by 43 seconds (an increase of 10%) compared to placebo.
Prvog dana liječenja inspiratorni kapacitet pod naporom poboljšao se za 230 ml, a vrijeme izdržavanja napora poboljšalo se za 43 sekunde (povećanje od 10%) u usporedbi s placebom.
In the 12-month study, the improvements were 87 ml at 5 minutes and 143 ml at 15 minutes (both p<0.001).
U 12-mjesečnom ispitivanju, poboljšanja su bila 87 ml nakon 5 minuta i 143 ml nakon 15 minuta (oba p<0,001).
In patients with COPD, pharmacokinetic steady-state of glycopyrronium was reached within one week of the start of treatment.
U bolesnika s KOPB-om, farmakokinetičko stanje dinamičke ravnoteže glikopironija bilo je postignuto u roku od tjedan dana od početka liječenja.
The absolute bioavailability of glycopyrromium inhaled via Tovanor Breezhaler was estimated to be about 45% of the delivered dose.
Procijenjeno je da je apsolutna bioraspoloživost glikopironija inhaliranog preko Tovanor Breezhalera oko 45% isporučene doze.