natgillin/translations-raw huggingface dataset:
In each study, patients were assigned to the low baseline platelet count cohort (˂ 40 x 109/L) or the high baseline platelet count cohort (≥ 40 to ˂ 50 x 109/L) based on their platelet count at baseline. 
U svakom su ispitivanju bolesnici bili svrstani u skupinu s niskom početnom vrijednošću broja trombocita (˂ 40 x 109/L) ili u skupinu s visokom početnom vrijednošću broja trombocita (≥ 40 do ˂ 50 x 109/L) na temelju njihove početne vrijednosti broja trombocita.
Adverse reactions are classified by Preferred Term and System Organ Class, and by frequency. 
Nuspojave su klasificirane prema preporučenom pojmu i klasifikaciji organskih sustava te po učestalosti.
A population pharmacokinetic analysis evaluated avatrombopag plasma exposures in patients with mild to moderate hepatic impairment based on Model for End-Stage Liver Disease (MELD) scores and Child-Turcotte-Pugh scores. 
Populacijska farmakokinetička analiza je procjenjivala izloženost avatrombopagu u plazmi u bolesnika s blagim do srednje teškim oštećenjem jetre na temelju rezultata modela za završni stadij bolesti jetre (MELD) i rezultata prema Child-Turcotte-Pugh klasifikaciji.
Portal vein thrombosis 
Tromboza portalne vene
Co-administered drug* 
Istodobno primijenjeni lijek *
There is limited information on the use of avatrombopag in patients previously exposed to avatrombopag. 
Podaci o uporabi avatrombopaga u bolesnika koji su mu već bili izloženi su ograničeni.
Cmax 
Cmaks
Based on in vitro studies, no other transporting proteins (OATP1B1, OATP1B3, OCT2, OAT1, and OAT3) are expected to play a significant role in the disposition of avatrombopag. 
(OATP1B1, OATP1B3, OCT2, OAT1 i OAT3) igrati važnu ulogu u dispoziciji avatrombopaga.
What Doptelet is and what it is used for 2. 
Što se nalazi u ovoj uputi: 1. Što je Doptelet i za što se koristi
In vitro studies suggest that avatrombopag is highly bound to human plasma proteins (> 96%). 
In vitro ispitivanja upućuju na to kako se avatrombopag jako vezuje na proteine ljudske plazme
The population pharmacokinetic analysis of avatrombopag in healthy subjects and subjects with thrombocytopenia due to chronic liver disease indicated similar exposures between healthy subjects and subjects with mild and moderate renal impairment (CrCL ≥ 30 mL/min, Cockcroft-Gault). 
Populacijska farmakokinetička analiza avatrombopaga u zdravih ispitanika i blesnika s trombocitopenijom uzrokovanom kroničnom bolešću jetre je ukazala na sličnu izloženost u zdravih ispitanika i ispitanika s blagim ili umjerenim oštećenjem funkcije bubrega (CrCL ≥ 30 ml/min,
Mean platelet count (+/- standard error) by days from start of dosing by baseline platelet count cohort and treatment group - pooled Study 1 and Study 2 
Slika 1: Srednja vrijednost broja trombocita (+/- standardna pogreška) od početka doziranja prikazano po danima, za kohorte prema početnoj vrijednosti broja trombocita i terapijske skupine, s obuhvaćenim podacima iz Ispitivanja 1 i Ispitivanja 2
There is limited information on the use of avatrombopag in patients with severe (Child-Pugh class C, MELD score > 24) hepatic impairment. 
Podaci o uporabi avatrombopaga u bolesnika s teškim (Child-Pugh C, MELD vrijednost > 24)
Doptelet 20 mg film-coated tablets avatrombopag 
Doptelet 20 mg filmom obložene tablete avatrombopag
Population pharmacokinetic analysis of avatrombopag plasma concentrations from the clinical studies with healthy subjects and patients with thrombocytopenia due to chronic liver disease indicated that avatrombopag exposures were similar across the different races studied. 
Rasne ili etničke skupine Farmakokinetička analiza populacije vezano uz koncentracije avatrombopaga u plazmi iz kliničkih ispitivanja u zdravih ispitanika i bolesnika s trombocitopenijom zbog kronične bolesti jetre je pokazala kako su izloženosti avatrombopagu bile slične kod svih ispitanih rasa.
Doptelet 20 mg tablets avatrombopag 
NAZIV LIJEKA Doptelet 20 mg tablete avatrombopag
Duration of dosing 
Trajanje doziranja
Each film-coated tablet contains avatrombopag maleate equivalent to 20 mg of avatrombopag. 
Jedna filmom obložena tableta sadrži 20 mg avatrombopaga u obliku avatrombopagmaleata.
Lactose monohydrate Microcrystalline cellulose (E460(i)) Crospovidone type B (E1202) Silica, colloidal anhydrous (E551) Magnesium stearate (E470b) 
Krospovidon vrsta B (E1202) Silicijev dioksid, koloidni, bezvodni (E551) Magnezijev stearat (E470b)
Patients with severe hepatic impairment should be supported in line with clinical practice by close monitoring for early signs of worsening or new onset hepatic encephalopathy, ascites, and thrombotic or bleeding tendency, through monitoring of liver function tests, tests used for assessing clotting status and through imaging of portal vasculature as needed. 
ascitesa i tendencije tromboze ili krvarenja praćenjem testova funkcije jetre, testova za procjenu koagulacije i putem snimanja portalne vaskulature po potrebi.
Due to limited information available, the safety and efficacy of avatrombopag in patients with severe hepatic impairment (Child-Pugh class C, MELD score > 24) have not been established (see section 4.4). 
Zbog ograničenosti dostupnih podataka o sigurnost i djelotvornosti avatrombopaga u bolesnika s teškim oštećenje jetre (Child-Pugh C, MELD (engl.
Package leaflet: Information for the patient Doptelet 20 mg film-coated tablets avatrombopag This medicine is subject to additional monitoring. 
Uputa o lijeku: Informacije za bolesnika Doptelet 20 mg filmom obložene tablete avatrombopag
Avatrombopag 40 mg (n = 58) Proportion of subjects not requiring a platelet transfusion or rescue procedure for bleeding Responders 95% CIa P-valueb Proportion of subjects who achieved a platelet count ≥ 50 × 109/L on procedure day Responders 95% CIa P-valueb Change in platelet count from baseline to procedure day Mean (SD) x 109/L Median x 109/L P-valuec a Two-sided 95% confidence interval based on normal approximation. 
Srednja vrijednost (SD) x 109/L Medijan x 109/L P vrijednostc a Dvostrani interval pouzdanosti od 95% utemeljen na normalnoj aproksimaciji.
The efficacy and safety of avatrombopag for the treatment of adult patients with chronic liver disease and a platelet count ˂ 50 x 109/L who were scheduled to undergo a procedure were studied in 2 identically-designed multicenter, randomised, double-blind, placebo-controlled Phase 3 studies (Study 1 and Study 2). 
Klinička djelotvornost i sigurnost Djelotvornost i sigurnost avatrombopaga u liječenju odraslih bolesnika s kroničnom bolešću jetre i brojem trombocita ˂ 50 x 109/L koji će biti podvrgnuti nekom invazivnom postupku ispitivane su u 2
In the low baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated group was 31.1 x 109/L and for placebo-treated patients was 30.7 x 109/L. 
U skupini s niskom početnom vrijednošću broja trombocita srednja početna vrijednost broja trombocita za skupinu liječenu avatrombopagom je bila 31,1 x 109/L, a za bolesnike liječene placebom 30,7 x 109/L.
In the low baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated group was 32.7 x 109/L and for placebo-treated patients was 32.5 x 109/L. 
U skupini s niskom početnom vrijednošću broja trombocita srednja početna vrijednost broja trombocita za skupinu liječenu avatrombopagom je bila 32,7 x 109/L, a za bolesnike liječene placebom 32,5 x 109/L.
Doptelet is used in adults with chronic liver disease to treat low platelet count (called thrombocytopenia) before having a medical procedure where there is a risk of bleeding. 
(stanje zvano trombocitopenija) prije podvrgavanja medicinskom postupku u kojem postoji rizik od krvarenja.
5 years. 
6.3 Rok valjanosti 5 godina.
In the high baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated patients was 44.3 x 109/L and for placebo-treated patients was 44.9 x 109/L. 
U skupini s visokom početnom vrijednošću broja trombocita srednja početna vrijednost broja trombocita za skupinu liječenu avatrombopagom je bila 44,3 x 109/L, a za bolesnike liječene placebom 44,9 x 109/L.
In the high baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated patients was 44.3 x 109/L and for placebo-treated patients was 44.5 x 109/L. 
U skupini s visokom početnom vrijednošću broja trombocita srednja početna vrijednost broja trombocita za skupinu liječenu avatrombopagom je bila 44,3 x 109/L, a za bolesnike liječene placebom 44,5 x 109/L.
Doptelet 20 mg 
16. PODACI NA BRAILLEOVOM PISMU Doptelet 20 mg
Avatrombopag 60 mg (n = 70) Proportion of subjects not requiring a platelet transfusion or rescue procedure for bleeding Responders 95% CIa P-valueb Proportion of subjects who achieved a platelet count ≥ 50 × 109/L on procedure day Responders 95% CIa P-valueb Change in platelet count from baseline to procedure day Mean (SD) x 109/L Median x 109/L P-valuec 
Udio ispitanika koji su postigli broj trombocita ≥ 50 × 109/L na dan postupka Bolesnici s odgovorom
Verapamil 
OBLIK
Retreatment 
Ponovljeno liječenje
Use in patients with chronic liver disease undergoing invasive procedures The objective of treatment with Doptelet is to increase platelet counts. 
Cilj liječenja Dopteletom je povećanje broja trombocita.
Memantine Accord should be given once a day at the same time every day. 
Memantin Accord treba primjenjivati jednom dnevno i potrebno ga je uzimati svaki dan u isto vrijeme.
It is used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour. 
Koristi se za liječenje bolesnika s umjerenom do ozbiljnom Alzheimerovom bolesti, tipom demencije (moždanog poremećaja) koji postepeno utječe na pamćenje, intelektualnu sposobnost i ponašanje.
Memantine Accord is available as tablets (5 mg, 10 mg, 15 mg and 20 mg) and can only be obtained with a prescription. 
Memantine Accord dostupan je kao tablete (5 mg, 10 mg, 15 mg i 20 mg) i izdaje se samo na liječnički recept.
Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with one another. 
Neurotransmiteri su kemikalije u živčanom sustavu koje omogućuju međusobnu komunikaciju živčanih stanica.
Treatment should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease. 
Liječenje treba započeti i nadzirati liječnik koji ima iskustva u dijagnosticiranju i liječenju Alzheimerove bolesti.
This means that Memantine Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Axura. 
To znači da je Memantine Accord sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Axura.
The full EPAR for Memantine Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za Memantine Accord može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
To prevent side effects, the dose of Memantine Accord is gradually increased over the first three weeks of treatment: during the first week, the daily dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day. 
Da bi se spriječile nuspojave, doza lijeka Memantine Accord postepeno se povećava tijekom prva tri tjedna liječenja: tijekom prvog tjedna dnevna doza iznosi 5 mg, u drugom tjednu doza iznosi 10 mg, a tijekom trećeg tjedna 15 mg.
The company provided data on the medicine's solubility, composition and absorption in the body. 
Farmaceutska tvrtka dostavila je podatke o topljivosti lijeka, sastavu i apsorpciji u tijelu.
A risk management plan has been developed to ensure that Memantine Accord is used as safely as possible. 
Pripremljen je plan upravljanja rizikom kako bi se osiguralo da se Memantine Accord koristi što je sigurnije moguće.
The cause of Alzheimer's disease is unknown, but memory loss in the disease is believed to be due to a disturbance of message signals in the brain. 
Uzrok Alzheimerove bolesti nije poznat, no vjeruje se da gubitak pamćenja u bolesti nastupa zbog poremećaja glasničkih signala u mozgu.
Memantine works by blocking types of receptors called N-methyl-D-aspartate (NMDA) receptors, to which the neurotransmitter glutamate normally attaches. 
Memantin djeluje blokirajući receptore naziva receptori N-metil-D-aspartata (NMDA), na koje se normalno veže neurotransmiter glutamata.
The dose may need to be reduced in patients who have moderate or severe problems with their kidneys. 
Doza će se možda morati smanjiti u bolesnika koji imaju umjerene do ozbiljne probleme s bubrezima.
By blocking NMDA receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of Alzheimer's disease. 
Inhibirajući receptore NMDA, memantin poboljšava prijenos signala u mozgu i smanjuje simptome Alzheimerove bolesti.
Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer's disease. 
Promjene u načinu na koji glutamat odašilje signale unutar mozga povezani su s gubitkom pamćenja uočenim u Alzheimerovoj bolesti.
The tolerance and dose should be assessed within three months after starting treatment, and from then on the benefits of continuing treatment with Memantine Accord should be re-assessed on a regular basis. 
Tolerancija i doza moraju se procijeniti unutar tri mjeseca nakon početka liječenja, te se od tada koristi kontinuiranog liječenja lijekom Memantine Accord moraju ponovno redovito procjenjivati.
Memantine Accord memantine 
Memantine Accord memantin
It is not intended to provide practical advice on how to use Memantine Accord. 
Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Memantine Accord.
Memantine Accord is a ‘generic medicine'. 
Memantine Accord je „generički lijek”.
The European Commission granted a marketing authorisation valid throughout the European Union for Memantine Accord on 04 December 2013. 
Europska komisija izdala je odobrenje za stavljanje u promet koje za Memantine Accord vrijedi na prostoru Europske unije od 04. prosinca 2013.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Memantine Accord, including the appropriate precautions to be followed by healthcare professionals and patients. 
Na temelju tog plana sigurnosne informacije uključene su u sažetak opisa svojstava lijeka kao i u uputu o lijeku Memantine Accord, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
Because Memantine Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Budući da je Memantine Accord generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegovi koristi i rizici isti kao i oni referentnog lijeka.
The Committee recommended that Memantine Accord be approved for use in the EU. 
Povjerenstvo je preporučilo odobrenje lijeka Memantine Accord za korištenje u EU-u.
Treatment should only be started if a caregiver is available who will regularly monitor the use of Memantine Accord by the patient. 
Terapiju treba započeti samo ako je dostupan njegovatelj koji će redovito nadzirati bolesnikovo uzimanje lijeka Memantine Accord.
What is Memantine Accord and what is it used for? 
Što je Memantine Accord i za što se koristi?
Therefore, the CHMP's view was that, as for Axura, the benefit outweighs the identified risk. 
Stoga je stav CHMP-a da, kao i kod lijeka Axura, koristi nadmašuju utvrđene rizike.
What measures are being taken to ensure the safe and effective use of Memantine Accord? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Memantine Accord?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine Accord has been shown to have comparable quality and is considered bioequivalent to Axura. 
Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je kako je, u skladu sa zahtjevima EU-a, potvrđeno da Memantine Accord posjeduje usporedivu kakvoću te je bioekvivalentan s lijekom Axura.
For more information about treatment with Memantine Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Više informacija o liječenju lijekom Memantine Accord pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
For practical information about using Memantine Accord, patients should read the package leaflet or contact their doctor or pharmacist. 
Praktične informacije o korištenju lijeka Memantine Accord bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
Other information about Memantine Accord 
Druge informacije o lijeku Memantine Accord
What are the benefits and risks of Memantine Accord? 
Koje su koristi i rizici lijeka Memantine Accord?
The active substance in Memantine Accord, memantine, is an antidementia medicine. 
Djelatna tvar u lijeku Memantine Accord, memantin, je lijek protiv demencije.
This is a summary of the European public assessment report (EPAR) for Memantine Accord. 
Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Memantine Accord.
Memantine Accord is a medicine that contains the active substance memantine. 
Memantine Accord je lijek koji sadrži djelatnu tvar memantin.
Why is Memantine Accord approved? 
Zašto je Memantine Accord odobren?
No additional studies in patients were required as Memantine Accord was shown to have comparable quality and is considered to be bioequivalent to the reference medicine, Axura. 
Nisu bila potrebna dodatna ispitivanja u bolesnika s obzirom da je dokazano da je Memantine Accord usporedive kvalitete te se smatra bioekvivalentom referentnog lijeka, Axura. „Bioekvivalent” znači da se očekuje od lijeka da stvara iste koncentracije djelatne tvari u tijelu.
How is Memantine Accord used? 
Kako se Memantine Accord koristi?
How does Memantine Accord work? 
Kako djeluje Memantine Accord?
How has Memantine Accord been studied? 
Kako se Memantine Accord ispitivao?
Although this difference is not large, it may benefit some patients. 
Iako ta razlika nije velika, može koristiti nekim bolesnicima.
There is a risk of severe allergic reactions, and although it is not known exactly how often these reactions occur, they appear to be rare. 
Postoji rizik od teških alergijskih reakcija, i iako nije poznato koliko često nastupaju te reakcije, čini se da su rijetke.
Further information on Alpivab can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Više informacija o lijeku Alpivab nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is given once only, within 48 hours after symptoms start. 
Lijek se primjenjuje samo jedanput, unutar 48 sati nakon pojave simptoma.
Alpivab is given as an infusion lasting 15 to 30 minutes. 
Alpivab se primjenjuje infuzijom u trajanju od 15 do 30 minuta.
The dose depends on age and body weight and should be reduced in adults and adolescents over 13 years of age with reduced kidney function. 
Doza ovisi o starosti i tjelesnoj težini te bi je trebalo smanjiti u odraslih osoba i adolescenata starijih od 13 godina sa smanjenom funkcijom bubrega.
What is Alpivab and what is it used for? 
Što je Alpivab i za što se koristi?
It is used to treat uncomplicated influenza (flu) in adults and children over 2 years. 
Primjenjuje se za liječenje nekomplicirane gripe (influenca) u odraslih osoba i djece starije od dvije godine.
What measures are being taken to ensure the safe and effective use of Alpivab? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Alpivab?
Side effects reported with Alpivab are carefully evaluated and any necessary action taken to protect patients. 
Nuspojave prijavljene za lijek Alpivab pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Other information about Alpivab 
Ostale informacije o lijeku Alpivab
What are the risks associated with Alpivab? 
Koji su rizici povezani s lijekom Alpivab?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alpivab have been included in the summary of product characteristics and the package leaflet. 
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Alpivab nalaze se u sažetku opisa svojstava i u uputi o lijeku.
Serious side effects with Alpivab are anaphylaxis (a severe allergic reaction) and skin reactions, including erythema multiforme (an allergic skin reaction) and Stevens-Johnson Syndrome (life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals). 
Ozbiljne nuspojave lijeka Alpivab su anafilaksa (teška alergijska reakcija) i reakcije kože, uključujući multiformni eritem (alergijska reakcija na koži) i Stevens-Johnsonov sindrom (po život opasna reakcija sa simptomima nalik gripi i bolnim osipom koji zahvaća kožu, usta, oči i genitalije).
Why is Alpivab authorised in the EU? 
Zašto je lijek Alpivab odobren u EU-u?
The European Medicines Agency decided that Alpivab's benefits are greater than its risks and it can be authorised for use in the EU. 
Europska agencija za lijekove zaključila je da koristi od lijeka Alpivab nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
Alpivab is an antiviral medicine that contains the active substance peramivir. 
Alpivab je antivirusni lijek koji sadrži djelatnu tvar peramivir.
As for all medicines, data on the use of Alpivab are continuously monitored. 
Kao za sve lijekove, podatci o primjeni lijeka Alpivab kontinuirano se prate.
Peramivir works on neuraminidases of both influenza-A (the most common type) and influenza-B viruses. 
Peramivir djeluje na neuraminidaze virusa influence A (najčešći tip) i influence B.
Alpivab was compared with placebo (a dummy treatment) in one main study of 296 adults with influenza (mostly influenza A) treated within 48 hours of symptoms appearing. 
Alpivab je uspoređen s placebom (prividno liječenje) u okviru jednog glavnog ispitivanja koje je obuhvaćalo 296 odraslih osoba s gripom (uglavnom influenca A) koje su primile lijek unutar 48 sati od pojave simptoma.
The most common side effects with Alpivab (which may affect up to around 3 in 100 people) are a decrease in the levels of neutrophils (a type of white blood cell) and nausea (feeling sick). 
Najčešće nuspojave lijeka Alpivab (koje se mogu javiti u manje od otprilike 3 na 100 osoba) jesu smanjenje broja neutrofila (vrsta bijelih krvnih stanica) i mučnina (slabost).
For more information about using Alpivab, see the package leaflet or contact your doctor or pharmacist. 
Više informacija o primjeni lijeka Alpivab pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
Uncomplicated means that the flu has typical features (such as fever, aches, cough, sore throat and runny nose) and is not made worse by other conditions. 
Nekomplicirana znači da gripa ima uobičajena obilježja (kao što su vrućica, bolovi, kašalj, grlobolja i hunjavica) te da je druga stanja ne pogoršavaju.
The main measure of effectiveness was the length of time before symptoms (cough, sore throat, headache, blocked nose, feverishness or chills, aches or pains of the muscle or joints and tiredness) got better. 
Glavno mjerilo djelotvornosti bilo je vrijeme koje je proteklo do poboljšanja simptoma (kašalj, grlobolja, glavobolja, začepljen nos, groznica ili zimica, bol i nelagoda u mišićima ili zglobovima te umor).
Alpivab reduces the length of time flu symptoms last by one day on average. 
Alpivab u prosjeku smanjuje duljinu trajanja simptoma gripe za jedan dan.