FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/011
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/283/011
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/008
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/283/008
English: ARICLAIM contains sucrose.
Croatian: ARICLAIM sadrži saharozu.
English: Despite this, your doctor may prescribe ARICLAIM for patients under 18 because he/she decides that this is in their best interests.
Croatian: bolesnicima mlađima od 18 godina ako procijeni da je to u njihovu najboljem interesu.
English: ARICLAIM contains sucrose
Croatian: ARICLAIM sadrži saharozu
English: • problems getting an erection, changes in ejaculation
Croatian: • bolno mokrenje, često mokrenje • otežano postizanje erekcije, promjene u ejakulaciji
English: Opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'.
Croatian: Neprozirno tijelo bijele boje s otisnutom oznakom ‘30 mg' i neprozirna plava kapica s otisnutom oznakom ‘9543'.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT REACH AND SIGHTREACH OF CHILDREN
Croatian: POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: Edible green ink: synthetic black iron oxide (E172), synthetic yellow iron oxide (E172), propylene glycol, shellac.
Croatian: Jestiva zelena tinta: sintetski crni željezov oksid (E172), sintetski žuti željezov oksid (E172), propilenglikol, šelak
English: Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Croatian: Neprozirno tijelo zelene boje s otisnutom oznakom ‘60 mg' i neprozirna plava kapica s otisnutom oznakom ‘9542'.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/011 (28 hard gastro-resistant capsules)
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/04/283/011 (28 tvrdih želučanootpornih kapsula)
English: 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
Croatian: 28 tvrdih želučanootpornih kapsula 98 tvrdih želučanootpornih kapsula
English: Multinucleated cells were seen in the liver in the absence of other histopathological changes in the rat carcinogenicity study.
Croatian: ispitivanju karcinogenosti u štakora primijećene su multinuklearne stanice u jetri, ali ne i druge histopatološke promjene.
English: • dehydration, low levels of sodium in the blood (mostly in elderly people; the symptoms may include feeling dizzy, weak, confused, sleepy or very tired, or feeling or being sick, more serious symptoms are fainting, fits or falls), syndrome of inappropriate secretion of anti-diuretic hormone (SIADH)
Croatian: • dehidracija, niske razine natrija u krvi (uglavnom u starijih ljudi; simptomi mogu uključivati osjećaj omaglice, slabost, smetenost, pospanost ili izrazit umor, mučninu ili povraćanje;
English: See section 4.2 for information on patients with mild or moderate renal dysfunction.
Croatian: Za bolesnike s teškim oštećenjem bubrežne funkcije vidjeti dio 4.3. Vidjeti dio 4.2 za informacije o bolesnicima s blagim ili umjerenim poremećajem bubrežne funkcije.
English: Adverse reactions may be more common during concomitant use of ARICLAIM and herbal preparations containing St John's wort (Hypericum perforatum).
Croatian: Pri istodobnom uzimanju lijeka ARICLAIM i biljnih pripravaka koji sadrže gospinu travu (Hypericum perforatum) nuspojave mogu biti češće.
English: • large pupils (the dark centre of the eye), problems with eyesight
Croatian: • velike zjenice (tamno središte oka), poteškoće s vidom • osjećaj omaglice ili „vrtnje“ (vrtoglavica), bol u uhu
English: Package leaflet: information for the user ARICLAIM 30 mg hard gastro-resistant capsules ARICLAIM 60 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)
Croatian: ARICLAIM 30 mg tvrde želučanootporne kapsule ARICLAIM 60 mg tvrde želučanootporne kapsule duloksetin (u obliku duloksetinklorida)
English: Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance <30 ml/min).
Croatian: Oštećenje bubrežne funkcije U bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 30 ml/min) koji su na hemodijalizi, koncentracije duloksetina u plazmi su povećane.
English: • weight gain
Croatian: • pojačano zijevanje
English: The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with ARICLAIM (see section 4.4).
Croatian: inhibitor i ne smije se davati bolesnicima koji se liječe lijekom ARICLAIM (vidjeti dio 4.4).
English: • constipation, diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion, breaking
Croatian: • zatvor, proljev, bol u želucu, povraćanje, žgaravica ili probavne tegobe, vjetrovi
English: The efficacy of duloxetine as a treatment for diabetic neuropathic pain was established in 2 randomised, 12-week, double-blind, placebo-controlled, fixed dose studies in adults (22 to 88 years) having diabetic neuropathic pain for at least 6 months.
Croatian: 12-tjedna, dvostruko slijepa, placebom kontrolirana ispitivanja fiksnih doza u odraslih (22 do
English: Very rare side effects (may affect up to 1 in 10,000 people) • inflammation of the blood vessels in the skin (cutaneous vasculitis)
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) • glavobolja, osjećaj pospanosti
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Edible white ink
Croatian: 60 mg: želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) željezov oksid, žuti (E172) bijela tinta, jestiva
English: Very common side effects (may affect more than 1 in 10 people)
Croatian: Vrlo rijetke nuspojave (mogu se javiti u najviše 1 na 10 000 osoba)
English: Caution is advisable if ARICLAIM is used concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like moclobemide or linezolid, St John's wort (Hypericum perforatum) or triptans, tramadol, pethidine and tryptophan (see section 4.4).
Croatian: tricikličkih antidepresiva poput klomipramina ili amitriptilina, inhibitora MAO poput moklobemida ili linezolida, gospine trave (Hypericum perforatum) ili triptana, tramadola, petidina i triptofana (vidjeti dio 4.4).
English: The corresponding figures for at least 50% pain reduction were 50% and 26% respectively.
Croatian: Smanjenje boli od najmanje 50% zabilježeno je u
English: ARICLAIM is for oral use.
Croatian: ARICLAIM se uzima kroz usta.
English: • suicidal behaviour, mania (over activity, racing thoughts and decreased need for sleep),
Croatian: • samoubilačko ponašanje, manija (prekomjerna aktivnost, brze misli i smanjena potreba za spavanjem), halucinacije, agresivnost i bijes • "serotoninski sindrom" (rijetka reakcija koja može uzrokovati osjećaj velike sreće,
English: General disorders and administration site conditions Falls8
Croatian: Opći poremećaji i reakcije na mjestu primjene umor padovi8
English: NAME OF THE MEDICINAL PRODUCT ARICLAIM 60 mg hard gastro-resistant capsules Duloxetine
Croatian: ARICLAIM 60 mg tvrde želučanootporne kapsule duloksetin
English: OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Croatian: OD LIJEKA, KADA JE POTREBNO
English: − are taking other medicines containing duloxetine (see ‘Other medicines and ARICLAIM') Talk to your doctor if you have high blood pressure or heart disease.
Croatian: − uzimate druge lijekove koji sadrže duloksetin (vidjeti ‘Drugi lijekovi i ARICLAIM'')
English: ARICLAIM contains the active substance duloxetine.
Croatian: Što je ARICLAIM i za što se koristi ARICLAIM sadrži djelatnu tvar duloksetin.
English: NAME OF THE MEDICINAL PRODUCT ARICLAIM 30 mg hard gastro-resistant capsules Duloxetine
Croatian: ARICLAIM 30 mg tvrde želučanootporne kapsule duloksetin
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible green ink
Croatian: Ovojnica kapsule: 30 mg: želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) zelena tinta, jestiva
English: What ARICLAIM looks like and contents of the pack ARICLAIM is a hard gastro-resistant capsule.
Croatian: ARICLAIM je tvrda želučanootporna kapsula.
English: NAME OF THE MEDICINAL PRODUCT ARICLAIM 60 mg hard gastro-resistant capsules
Croatian: ARICLAIM 60 mg tvrde želučanootporne kapsule
English: NAME OF THE MEDICINAL PRODUCT ARICLAIM 30 mg hard gastro-resistant capsules
Croatian: ARICLAIM 30 mg tvrde želučanootporne kapsule
English: The main ingredient of ARICLAIM, duloxetine, is used in other medicines for other conditions:
Croatian: Duloksetin, glavni sastojak lijeka ARICLAIM, nalazi se i u nekim drugim lijekovima koji se koriste za liječenje drugih stanja: • depresije, tjeskobe i inkontinencije mokraće
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 30 MG HARD GASTRO-RESISTANT CAPSULES
Croatian: KUTIJE ZA 30 MG TVRDE ŽELUČANOOTPORNE KAPSULE
English: • “Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
Croatian: omamljenost, nespretnost, nemir, osjećaj opijenosti, vrućicu, znojenje ili ukočene mišiće),
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children.
Croatian: Na temelju ispitivanja provedenog na 6 bolesnica u laktaciji koje nisu dojile svoju djecu pokazalo se da se duloksetin u majčino mlijeko izlučuje u vrlo maloj mjeri.
English: BATCH NUMBER Lot
Croatian: BROJ SERIJE Broj serije
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 60 MG HARD GASTRO-RESISTANT CAPSULES
Croatian: KUTIJE ZA 60 MG TVRDE ŽELUČANOOTPORNE KAPSULE
English: Each capsule contains 60 mg of duloxetine (as hydrochloride).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna kapsula sadrži 60 mg duloksetina (u obliku duloksetinklorida).
English: Palpitations
Croatian: FARMACEUTSKI
English: Each capsule contains 30 mg of duloxetine (as hydrochloride).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna kapsula sadrži 30 mg duloksetina (u obliku duloksetinklorida).
English: Very Rare disorder Ejaculation delayed disorder Sexual dysfunction Testicular pain
Croatian: U otvorenom dugotrajnom nekontroliranom ispitivanju smanjenje boli u bolesnika koji su reagirali na
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva bol spazam mišića trzanje mišića trizmus
English: The concomitant use of ARICLAIM with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Croatian: MAO, poput moklobemida (vidjeti dio 4.4).
English: - are taking medicines to treat depression (see ‘Other medicines and ARICLAIM') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises) - are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) - are currently being treated with another medicine which may cause liver damage - are taking other medicines containing duloxetine (see ‘Other medicines and ARICLAIM')
Croatian: - patite od bipolarnog poremećaja - imate probleme s očima poput određenih vrsta glaukoma (povišen očni tlak) - u povijesti bolesti imate poremećaje krvarenja (sklonost pojavi modrica)
English: Urine odour abnormal
Croatian: • stezanje mišića čeljusti • neuobičajen miris mokraće
English: The treatment duration was up to 2 years.
Croatian: Liječenje je trajalo do dvije godine.
English: The timetable for the implementation of the agreement is set out in Annex III.
Croatian: Rok za provedbu sporazuma naznačen je u Prilogu III.
English: Spontaneous reports
Croatian: Spontane prijave
English: Efficacy
Croatian: Učinkovitost
English: • Respiratory events, mainly due to awareness of respiratory movements
Croatian: • respiratorne nuspojave, uglavnom zbog svjesnosti respiratornih pokreta
English: The PRAC took in account the MAH's position.
Croatian: PRAC je uzeo u obzir stav MAH-a.
English: The first Marketing Authorisation in the EU was granted in France on 10 December 1982.
Croatian: Prvo odobrenje za stavljanje gotovog lijeka u promet u EU izdano je u Francuskoj 10. prosinca 1982.
English: In 50% of the cases, a neuropathy was also reported.
Croatian: U 50% slučajeva zabilježena je i neuropatija.
English: Data from clinical trials
Croatian: Podaci dobiveni iz kliničkih ispitivanja
English: In addition, the PRAC noted that the mechanism of these 2 adverse reactions remains unknown.
Croatian: Osim toga, PRAC je istaknuo da mehanizam tih dviju nuspojava ostaje nepoznat.
English: The MAH has never performed trials or investigations to document/establish the mechanism of action of these adverse effects.
Croatian: MAH nikad nije proveo ispitivanja ili istraživanja da bi dokumentirao/utvrdio mehanizam djelovanja tih nuspojava.
English: The mean time to onset for the cases reported was 5 months but time to onset was variable ranging from 15 days to 2,5 years.
Croatian: Prosječno vrijeme pojavljivanja zabilježenih slučajeva bilo je pet mjeseci, no vrijeme pojavljivanja variralo je od 15 dana do 2,5 godine.
English: In the view of the negative benefit risk balance, patients will need to be switched to alternative therapies.
Croatian: U pogledu negativne uravnoteženosti koristi i rizika, pacijenti će morati biti prebačeni na zamjenske terapije.
English: No effect was nor observed on pulmonary functional status.
Croatian: Ni jedan učinak nije uočen vezano za plućni funkcionalni status.
English: However, no data supports the restrictive indication proposed by the MAH.
Croatian: Međutim, ni jedan podatak ne podupire ograničenu indikaciju koju je predložio MAH.
English: Almitrine containing medicinal products for oral use are currently authorised in 3 European Member States (France, Poland and Portugal) and only marketed in France and Poland (see Annex I for the list of almitrine containing medicinal products for oral use authorised in the EU).
Croatian: Medicinski proizvodi za oralnu primjenu koji sadrže almitrin trenutačno su odobreni u tri europske države članice (Francuska, Poljska i Portugal), a u promet su stavljeni samo u Francuskoj i Poljskoj (vidjeti Prilog I. za popis medicinskih proizvoda za oralnu primjenu koji sadrže almitrin odobrenih u EU).
English: In addition, France had concerns with regards to the benefit of almitrine in its approved indications.
Croatian: Osim toga, Francuska je izrazila zabrinutost vezano za koristi almitrina u njegovim odobrenim indikacijama.
English: In November 2012 the French National Competent Authority considered that the above-mentioned major safety concerns were not fully controlled in clinical practice despite the risk minimisation measures in place.
Croatian: U studenom 2012. francusko nacionalno nadležno tijelo zaključilo je da prethodno navedena ozbiljna pitanja sigurnosti nisu u potpunosti kontrolirana u kliničkoj praksi, usprkos mjerama smanjenja rizika koje su bile na snazi.
English: Scientific conclusions and grounds for the revocation of the marketing authorisations
Croatian: Znanstveni zaključci i razlozi za opoziv odobrenja za stavljanje gotovog lijeka u promet
English: The PRAC is of the opinion that almitrine cannot be considered as an alternative to LTOT for which reduction in mortality has been achieved.
Croatian: PRAC smatra da se almitrin ne može smatrati zamjenom za LTOT kod kojeg je postignuto smanjenje stope smrtnosti.
English: An important proportion of cases seems to have been reported with an outcome as not recovered during the period from September 2003 to December 2012 (5 cases of the 7 reported).
Croatian: Čini se da je značajan dio slučajeva zabilježen s ishodom neoporavka tijekom razdoblja od rujna 2003. do prosinca 2012. (pet slučajeva od sedam prijavljenih).
English: Consideration that long-term oxygen therapy can be discontinued, delayed or even avoided with almitrine is not based on scientific or clinical evidence.
Croatian: Razmatranja da se dugoročna terapija kisikom može prekinuti, odgoditi ili čak izbjeći uz primjenu almitrina ne temelji se na znanstvenim ili kliničkim dokazima.
English: Finally the PRAC noted that the current international consensus for the management of COPD and chronic hypoxemia (Global Initiative for Obstructive Lung Disease (GOLD) and other practical recommendation) does no longer refer to the use of almitrine.
Croatian: PRAC je naposljetku primijetio da se trenutačni međunarodni konsenzus za upravljanje KOBP-om i kroničnom hipoksemijom (Globalna inicijativa za kroničnu opstruktivnu plućnu bolest (GOLD) i ostale praktične preporuke) više ne odnosi na primjenu almitrina.
English: Globally, an important proportion of cases had an outcome reported as not recovered or recovered with sequelae (489 cases out of the 2304 reported, i.e. 21.2%).
Croatian: U globalnom smislu, u većem je dijelu slučajeva zabilježen ishod neoporavka ili oporavka s posljedicama (sequlae) (489 slučajeva od 2304 prijavljena slučaja, odnosno 21,2%).
English: The PRAC noted that weight loss reported led to almitrine discontinuation in 90,9% of the cases.
Croatian: PRAC je istaknuo da je zabilježeni gubitak težine doveo do prekida primjene almitrina u 90,9% slučajeva.
English: Weight loss observed in patients with respiratory insufficiency is progressive.
Croatian: Gubitak težine zabilježen u ispitanika s respiratornom insuficijencijom je progresivan.
English: The decrease in reporting of peripheral neuropathy mentioned by the MAH, is probably mainly related to the decrease in sales over the last 10 years.
Croatian: Smanjenje zabilježenih slučajeva periferne neuropatije koje je naveo MAH vjerojatno je uglavnom povezano sa smanjenjem prodaje u posljednjih 10 godina.
English: Moreover, no data is available to support any benefit of almitrine in the restrictive indication proposed by the MAH (patient with PaO2: 55 mmHg< PaO2< 65 mmHg).
Croatian: Štoviše, nisu dostupni podaci koji bi poduprli bilo koju korist almitrina u ograničenoj indikaciji koju predlaže MAH (ispitanik s PaO2: 55 mmHg < PaO2 < 65 mmHg).
English: In view of the 11 above mentioned published clinical studies, it is acknowledged that efficacy results among clinical studies are contradictory and extrapolations not feasible.
Croatian: S obzirom na 11 navedenih objavljenih kliničkih ispitivanja, priznaje se da su rezultati učinkovitosti različitih kliničkih ispitivanja kontradiktorni i da ekstrapolacije nisu moguće.
English: Regarding weight loss, 795 cases were reported since launch, some of them severe.
Croatian: Vezano za gubitak težine, od stavljanja lijeka u promet zabilježeno je 795 slučajeva, od kojih su neki bili ozbiljni.
English: Hypoxemia alone is not sufficient to explain severe weight loss reported with almitrine.
Croatian: Sama hipoksemija nije dovoljna za objašnjenje ozbiljnog gubitka težine povezanog s almitrinom.
English: This was supported by the fact that cases of peripheral neuropathy continued to be reported from September 2003 to November 2012 despite the implemented minimisation measures (recommendation for a sequential scheme of administration and dose adjustment initially, followed by contra-indications and warnings).
Croatian: Navedeno je poduprto činjenicom da su od rujna 2003. do studenog 2012. prijavljivani slučajevi periferne neuropatije, usprkos provedenim mjerama smanjenja rizika (preporuka za sekvencijalnu shemu primjene i prilagodbe prvotne doze, nakon čega slijede kontraindikacije i upozorenja).
English: The PRAC considered that many of the publications reported that a clinical benefit of oral almitrine could not be seen in terms of exacerbations or hospitalisation, exercise capacity, clinical outcome, survival, or quality of life.
Croatian: PRAC je smatrao da je u mnogim publikacijama zabilježeno da klinička korist oralne primjene almitrina nije vidljiva u smislu egzacerbacija ili hospitalizacije, kapaciteta vježbanja, kliničkog ishoda, preživljavanja ili kvalitete života.
English: During the period September 2003 to December 2012, 20 cases of peripheral neuropathies were reported, suggesting that the risk minimisation measures are not able to prevent the occurrence of these reactions.
Croatian: Tijekom razdoblja između rujna 2003. i prosinca 2012. zabilježeno je 20 slučajeva perifernih neuropatija, što ukazuje na to da mjere smanjenja rizika ne mogu spriječiti pojavljivanje navedenih nuspojava.
English: Spontaneous reports of peripheral neuropathies persist even after the introduction of sequential administration scheme.
Croatian: Spontane prijave perifernih neuropatija zabilježene su i nakon uvođenja sheme sekvencijalne primjene.
English: In published clinical studies with continuous administration1234567, peripheral neuropathies and weight loss were encountered when the study duration was longer than 3 months, indicating that the duration of continuous exposure have played a role in their development.
Croatian: U objavljenim kliničkim ispitivanjima sa stalnom primjenom,1234567, periferne neuropatije i gubitak težine zabilježeni su u slučajevima kad je trajanje ispitivanja bilo duže od tri mjeseca, ukazujući na to da je trajanje stalne izloženosti utjecalo na njihov razvoj.
English: Besides, the PRAC also noted that the knowledge in physiopatholigical mechanism and management of COPD (including life expectancy in COPD) has been considerably improved.
Croatian: Osim toga, PRAC je također istaknuo značajan napredak znanja koje se odnosi na fiziopatološki mehanizam i upravljanje KOBP-om (uključujući očekivani životni vijek kod KOBP-a).
English: The PRAC noted that most cases of peripheral neuropathies reported from September 2003 to December 2012 were not recovered or recovered with sequelae.
Croatian: PRAC je istaknuo da se većina slučajeva perifernih neuropatija zabilježenih od rujna 2003. do prosinca 2012. nije oporavila ili se oporavila s posljedicama.
English: One of the proposed further risk minimisation measures by the MAH was a restricted indication in patients with PaO2 between 55 mmHg and 65 mmHg or as adjuvant treatment to Long Term Oxygen Therapy (LTOT).
Croatian: Jedna od predloženih daljnjih mjera smanjenja rizika MAH-a bila je restriktivna indikacija u ispitanika s PaO2 između 55 mmHG i 65 mmHg ili kao adjuvantno liječenje dugoročne terapije kisikom (LTOT).
English: The NCAs should undertake timely actions allowing an appropriate switching of patients to other therapeutic alternatives.
Croatian: Nacionalna nadležna tijela trebala bi poduzeti pravovremene korake radi osiguranja odgovarajućeg prebacivanja pacijenata na ostale zamjenske terapije.
English: The doses of 100-200 mg of almitrine continuously were associated with a higher incidence of adverse effects and withdrawals compared to placebo.
Croatian: Doze od 100 do 200 mg almitrina kontinuirano su bile povezivane s učestalijim štetnim događajima i ustezanjem u usporedbi s placebom.
English: Taken together, these clinical trials enrolled 2036 patients (1380 under almitrine, 656 under placebo).
Croatian: Ukupno su navedena klinička ispitivanja uključivala 2036 ispitanika (1380 ih je primalo almitrin, a 656 placebo).