natgillin/translations-raw huggingface dataset:
In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of ARICLAIM 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory (BPI) 24-hour average pain item. 
8-tjedno akutno liječenje lijekom ARICLAIM u dozi od 60 mg jednom dnevno održalo se tijekom sljedećih 6 mjeseci, mjereno promjenom 24-satnih podataka o prosječnoj boli u kratkom upitniku o boli (eng.
Infections and infestations Immune system disorders 
Infekcije i infestacije
Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of ARICLAIM in this age group have not yet been demonstrated. 
ARICLAIM na rast, sazrijevanje te intelektualni razvoj i razvoj ponašanja nisu još dokazani u ovoj dobnoj skupini.
The 60 mg capsules are blue and green and are printed with ‘60 mg' and the code ‘9542'. 
Kapsule od 60 mg su plave i zelene boje s otisnutim oznakom ‘60 mg' i oznakom ‘9542'.
Medicines that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St John's Wort and MAOIs (such as moclobemide and linezolid). 
Lijekovi koji povećavaju razinu serotonina: triptani, tramadol, triptofan, SSRI (poput paroksetina i fluoksetina), inhibitori ponovne pohrane serotonina i noradrenalina (poput venlafaksina), triciklički antidepresivi (poput klomipramina, amitriptilina), petidin, gospina trava i inhibitori MAO (poput moklobemida i linezolida).
Read the leaflet before use. 
Prije uporabe pročitati uputu o lijeku.
ARICLAIM hard gastro-resistant capsules contain sucrose. 
ARICLAIM tvrde želučanootporne kapsule sadrže saharozu.
ARICLAIM must not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2). 
Oštećenje jetrene funkcije ARICLAIM se ne smije primjenjivati u bolesnika s bolešću jetre čija je posljedica oštećenje jetrene funkcije (vidjeti dijelove 4.3 i 5.2).
The 30 mg capsules are blue and white and are printed with ‘30 mg' and the code ‘9543'. 
Kapsule od 30 mg su plave i bijele boje s otisnutim oznakom ‘30 mg' i oznakom ‘9543'.
No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/min). 
U bolesnika s blagom ili umjerenom disfunkcijom bubrežne funkcije (klirens kreatinina 30 do 80 ml/min) nije potrebna prilagodba doze.
7 hard gastro-resistant capsules 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules 
7 tvrdih želučanootpornih kapsula 28 tvrdih želučanootpornih kapsula 98 tvrdih želučanootpornih kapsula
The use of ARICLAIM while breastfeeding is not recommended. 
Ne preporučuje se uzimanje lijeka ARICLAIM za vrijeme dojenja.
Stomatitis Haematochezia Breath odour Microscopic colitis 
Poremećaji probavnog sustava mučnina suha usta stomatitis hematohezija zadah iz usta mikroskopski kolitis9
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE
Dehydration Hyponatraemia SIADH6 
Poremećaji metabolizma i prehrane dehidracija hiponatrijemija SIADH6
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvođač Nositelj odobrenja za stavljanje gotovog lijeka u promet: Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
Syncope2 Hypertension3,7 
crvenilo uz osjećaj vrućine sinkopa2 hipertenzija3,7
Edible white ink: titanium dioxide (E171), propylene glycol, shellac, povidone. 
Jestiva bijela tinta: titanijev dioksid (E171), propilenglikol, šelak, povidon
− have severe kidney disease 
− imate tešku bolest bubrega
• difficulty or inability to pass urine, difficulty to start urinating, needing to pass urine during the night, needing to pass more urine than normal, having a decreased urine flow 
• otežano ili nemogućnost mokrenja, otežan početak mokrenja, potreba za mokrenjem tijekom noći, pojačana potreba za mokrenjem, smanjen protok mokraće
MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/011 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/283/011
MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/008 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/283/008
ARICLAIM contains sucrose. 
ARICLAIM sadrži saharozu.
Despite this, your doctor may prescribe ARICLAIM for patients under 18 because he/she decides that this is in their best interests. 
bolesnicima mlađima od 18 godina ako procijeni da je to u njihovu najboljem interesu.
ARICLAIM contains sucrose 
ARICLAIM sadrži saharozu
• problems getting an erection, changes in ejaculation 
• bolno mokrenje, često mokrenje • otežano postizanje erekcije, promjene u ejakulaciji
Opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'. 
Neprozirno tijelo bijele boje s otisnutom oznakom ‘30 mg' i neprozirna plava kapica s otisnutom oznakom ‘9543'.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT REACH AND SIGHTREACH OF CHILDREN 
POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
Edible green ink: synthetic black iron oxide (E172), synthetic yellow iron oxide (E172), propylene glycol, shellac. 
Jestiva zelena tinta: sintetski crni željezov oksid (E172), sintetski žuti željezov oksid (E172), propilenglikol, šelak
Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'. 
Neprozirno tijelo zelene boje s otisnutom oznakom ‘60 mg' i neprozirna plava kapica s otisnutom oznakom ‘9542'.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/011 (28 hard gastro-resistant capsules) 
12. BROJEVI ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/04/283/011 (28 tvrdih želučanootpornih kapsula)
28 hard gastro-resistant capsules 98 hard gastro-resistant capsules 
28 tvrdih želučanootpornih kapsula 98 tvrdih želučanootpornih kapsula
Multinucleated cells were seen in the liver in the absence of other histopathological changes in the rat carcinogenicity study. 
ispitivanju karcinogenosti u štakora primijećene su multinuklearne stanice u jetri, ali ne i druge histopatološke promjene.
• 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) 
• dehidracija, niske razine natrija u krvi (uglavnom u starijih ljudi; simptomi mogu uključivati osjećaj omaglice, slabost, smetenost, pospanost ili izrazit umor, mučninu ili povraćanje;
See section 4.2 for information on patients with mild or moderate renal dysfunction. 
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.
Adverse reactions may be more common during concomitant use of ARICLAIM and herbal preparations containing St John's wort (Hypericum perforatum). 
Pri istodobnom uzimanju lijeka ARICLAIM i biljnih pripravaka koji sadrže gospinu travu (Hypericum perforatum) nuspojave mogu biti češće.
• large pupils (the dark centre of the eye), problems with eyesight 
• velike zjenice (tamno središte oka), poteškoće s vidom • osjećaj omaglice ili „vrtnje“ (vrtoglavica), bol u uhu
Package leaflet: information for the user ARICLAIM 30 mg hard gastro-resistant capsules ARICLAIM 60 mg hard gastro-resistant capsules Duloxetine (as hydrochloride) 
ARICLAIM 30 mg tvrde želučanootporne kapsule ARICLAIM 60 mg tvrde želučanootporne kapsule duloksetin (u obliku duloksetinklorida)
Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance <30 ml/min). 
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.
• weight gain 
• pojačano zijevanje
The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with ARICLAIM (see section 4.4). 
inhibitor i ne smije se davati bolesnicima koji se liječe lijekom ARICLAIM (vidjeti dio 4.4).
• constipation, diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion, breaking 
• zatvor, proljev, bol u želucu, povraćanje, žgaravica ili probavne tegobe, vjetrovi
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. 
12-tjedna, dvostruko slijepa, placebom kontrolirana ispitivanja fiksnih doza u odraslih (22 do
Very rare side effects (may affect up to 1 in 10,000 people) • inflammation of the blood vessels in the skin (cutaneous vasculitis) 
Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) • glavobolja, osjećaj pospanosti
Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Edible white ink 
60 mg: želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) željezov oksid, žuti (E172) bijela tinta, jestiva
Very common side effects (may affect more than 1 in 10 people) 
Vrlo rijetke nuspojave (mogu se javiti u najviše 1 na 10 000 osoba)
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). 
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).
The corresponding figures for at least 50% pain reduction were 50% and 26% respectively. 
Smanjenje boli od najmanje 50% zabilježeno je u
ARICLAIM is for oral use. 
ARICLAIM se uzima kroz usta.
• suicidal behaviour, mania (over activity, racing thoughts and decreased need for sleep), 
• 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,
General disorders and administration site conditions Falls8 
Opći poremećaji i reakcije na mjestu primjene umor padovi8
NAME OF THE MEDICINAL PRODUCT ARICLAIM 60 mg hard gastro-resistant capsules Duloxetine 
ARICLAIM 60 mg tvrde želučanootporne kapsule duloksetin
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
OD LIJEKA, KADA JE POTREBNO
− are taking other medicines containing duloxetine (see ‘Other medicines and ARICLAIM') Talk to your doctor if you have high blood pressure or heart disease. 
− uzimate druge lijekove koji sadrže duloksetin (vidjeti ‘Drugi lijekovi i ARICLAIM'')
ARICLAIM contains the active substance duloxetine. 
Što je ARICLAIM i za što se koristi ARICLAIM sadrži djelatnu tvar duloksetin.
NAME OF THE MEDICINAL PRODUCT ARICLAIM 30 mg hard gastro-resistant capsules Duloxetine 
ARICLAIM 30 mg tvrde želučanootporne kapsule duloksetin
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible green ink 
Ovojnica kapsule: 30 mg: želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) zelena tinta, jestiva
What ARICLAIM looks like and contents of the pack ARICLAIM is a hard gastro-resistant capsule. 
ARICLAIM je tvrda želučanootporna kapsula.
NAME OF THE MEDICINAL PRODUCT ARICLAIM 60 mg hard gastro-resistant capsules 
ARICLAIM 60 mg tvrde želučanootporne kapsule
NAME OF THE MEDICINAL PRODUCT ARICLAIM 30 mg hard gastro-resistant capsules 
ARICLAIM 30 mg tvrde želučanootporne kapsule
The main ingredient of ARICLAIM, duloxetine, is used in other medicines for other conditions: 
Duloksetin, glavni sastojak lijeka ARICLAIM, nalazi se i u nekim drugim lijekovima koji se koriste za liječenje drugih stanja: • depresije, tjeskobe i inkontinencije mokraće
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 30 MG HARD GASTRO-RESISTANT CAPSULES 
KUTIJE ZA 30 MG TVRDE ŽELUČANOOTPORNE KAPSULE
• “Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), 
omamljenost, nespretnost, nemir, osjećaj opijenosti, vrućicu, znojenje ili ukočene mišiće),
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children. 
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.
BATCH NUMBER Lot 
BROJ SERIJE Broj serije
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 60 MG HARD GASTRO-RESISTANT CAPSULES 
KUTIJE ZA 60 MG TVRDE ŽELUČANOOTPORNE KAPSULE
Each capsule contains 60 mg of duloxetine (as hydrochloride). 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna kapsula sadrži 60 mg duloksetina (u obliku duloksetinklorida).
Palpitations 
FARMACEUTSKI
Each capsule contains 30 mg of duloxetine (as hydrochloride). 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna kapsula sadrži 30 mg duloksetina (u obliku duloksetinklorida).
Very Rare disorder Ejaculation delayed disorder Sexual dysfunction Testicular pain 
U otvorenom dugotrajnom nekontroliranom ispitivanju smanjenje boli u bolesnika koji su reagirali na
Musculoskeletal and connective tissue disorders 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva bol spazam mišića trzanje mišića trizmus
The concomitant use of ARICLAIM with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4). 
MAO, poput moklobemida (vidjeti dio 4.4).
- 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') 
- patite od bipolarnog poremećaja - imate probleme s očima poput određenih vrsta glaukoma (povišen očni tlak) - u povijesti bolesti imate poremećaje krvarenja (sklonost pojavi modrica)
Urine odour abnormal 
• stezanje mišića čeljusti • neuobičajen miris mokraće
The treatment duration was up to 2 years. 
Liječenje je trajalo do dvije godine.
The timetable for the implementation of the agreement is set out in Annex III. 
Rok za provedbu sporazuma naznačen je u Prilogu III.
Spontaneous reports 
Spontane prijave
Efficacy 
Učinkovitost
• Respiratory events, mainly due to awareness of respiratory movements 
• respiratorne nuspojave, uglavnom zbog svjesnosti respiratornih pokreta
The PRAC took in account the MAH's position. 
PRAC je uzeo u obzir stav MAH-a.
The first Marketing Authorisation in the EU was granted in France on 10 December 1982. 
Prvo odobrenje za stavljanje gotovog lijeka u promet u EU izdano je u Francuskoj 10. prosinca 1982.
In 50% of the cases, a neuropathy was also reported. 
U 50% slučajeva zabilježena je i neuropatija.
Data from clinical trials 
Podaci dobiveni iz kliničkih ispitivanja
In addition, the PRAC noted that the mechanism of these 2 adverse reactions remains unknown. 
Osim toga, PRAC je istaknuo da mehanizam tih dviju nuspojava ostaje nepoznat.
The MAH has never performed trials or investigations to document/establish the mechanism of action of these adverse effects. 
MAH nikad nije proveo ispitivanja ili istraživanja da bi dokumentirao/utvrdio mehanizam djelovanja tih nuspojava.
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. 
Prosječno vrijeme pojavljivanja zabilježenih slučajeva bilo je pet mjeseci, no vrijeme pojavljivanja variralo je od 15 dana do 2,5 godine.
In the view of the negative benefit risk balance, patients will need to be switched to alternative therapies. 
U pogledu negativne uravnoteženosti koristi i rizika, pacijenti će morati biti prebačeni na zamjenske terapije.
No effect was nor observed on pulmonary functional status. 
Ni jedan učinak nije uočen vezano za plućni funkcionalni status.
However, no data supports the restrictive indication proposed by the MAH. 
Međutim, ni jedan podatak ne podupire ograničenu indikaciju koju je predložio MAH.
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). 
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).
In addition, France had concerns with regards to the benefit of almitrine in its approved indications. 
Osim toga, Francuska je izrazila zabrinutost vezano za koristi almitrina u njegovim odobrenim indikacijama.
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. 
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.
Scientific conclusions and grounds for the revocation of the marketing authorisations 
Znanstveni zaključci i razlozi za opoziv odobrenja za stavljanje gotovog lijeka u promet
The PRAC is of the opinion that almitrine cannot be considered as an alternative to LTOT for which reduction in mortality has been achieved. 
PRAC smatra da se almitrin ne može smatrati zamjenom za LTOT kod kojeg je postignuto smanjenje stope smrtnosti.
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). 
Čini se da je značajan dio slučajeva zabilježen s ishodom neoporavka tijekom razdoblja od rujna 2003. do prosinca 2012. (pet slučajeva od sedam prijavljenih).
Consideration that long-term oxygen therapy can be discontinued, delayed or even avoided with almitrine is not based on scientific or clinical evidence. 
Razmatranja da se dugoročna terapija kisikom može prekinuti, odgoditi ili čak izbjeći uz primjenu almitrina ne temelji se na znanstvenim ili kliničkim dokazima.
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. 
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.
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%). 
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%).
The PRAC noted that weight loss reported led to almitrine discontinuation in 90,9% of the cases. 
PRAC je istaknuo da je zabilježeni gubitak težine doveo do prekida primjene almitrina u 90,9% slučajeva.
Weight loss observed in patients with respiratory insufficiency is progressive. 
Gubitak težine zabilježen u ispitanika s respiratornom insuficijencijom je progresivan.
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. 
Smanjenje zabilježenih slučajeva periferne neuropatije koje je naveo MAH vjerojatno je uglavnom povezano sa smanjenjem prodaje u posljednjih 10 godina.
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). 
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).
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. 
S obzirom na 11 navedenih objavljenih kliničkih ispitivanja, priznaje se da su rezultati učinkovitosti različitih kliničkih ispitivanja kontradiktorni i da ekstrapolacije nisu moguće.
Regarding weight loss, 795 cases were reported since launch, some of them severe. 
Vezano za gubitak težine, od stavljanja lijeka u promet zabilježeno je 795 slučajeva, od kojih su neki bili ozbiljni.
Hypoxemia alone is not sufficient to explain severe weight loss reported with almitrine. 
Sama hipoksemija nije dovoljna za objašnjenje ozbiljnog gubitka težine povezanog s almitrinom.
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). 
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).
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. 
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.
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. 
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.
Spontaneous reports of peripheral neuropathies persist even after the introduction of sequential administration scheme. 
Spontane prijave perifernih neuropatija zabilježene su i nakon uvođenja sheme sekvencijalne primjene.