FrancophonIA/ELRC3.0 huggingface dataset:
English: Exacerbation of hepatitis:
Croatian: Egzacerbacija hepatitisa:
English: Clinical resistance: Lamivudine-refractory patients and patients harbouring HBV with evidence of resistance to lamivudine (mutations at rtL180M, rtA181T and/or rtM204I/V) should not be treated with adefovir dipivoxil monotherapy in order to reduce the risk of resistance to adefovir.
Croatian: Klinička rezistencija: Pacijenti koji ne odgovaraju na lamivudin i pacijenti koji su nositelji HBV-a s dokazanom rezistencijom na lamivudin (mutacije na rtL180M, rtA181T i/ili rtM204I/V) ne smiju biti liječeni monoterapijom adefovirdipivoksila kako bi se smanjio rizik od razvoja rezistencije na adefovir.
English: Hepsera 10 mg tablets Adefovir dipivoxil
Croatian: Hepsera 10 mg tablete adefovirdipivoksil
English: Clinical resistance in monotherapy studies in nucleoside naïve patients: In patients receiving adefovir dipivoxil monotherapy (HBeAg negative study) the cumulative probability of developing adefovir-associated resistance mutations was 0 %, 3 %, 11 %, 18 % and 29 % at 48, 96, 144, 192 and 240 weeks respectively.
Croatian: Klinička rezistencija u ispitivanjima monoterapije u pacijenata koji prethodno nisu primali nukleozide: U pacijenata koji su primali monoterapiju adefovirdipivoksilom (ispitivanja s HBeAg negativnim pacijentima) kumulativna vjerojatnost razvoja mutacija povezanih s rezistencijom na adefovir bile su 0% u 48. tjednu, 3% u 96., 11% u 144., 18% u 192. i 29% u 240. tjednu.
English: Gilead Sciences Ltd Tel: + 44 (0) 8000 113 700
Croatian: United Kingdom Gilead Sciences Ltd Tel: + 44 (0) 8000 113 700
English: No effects on male or female fertility, or reproductive performance, occurred in rats and there was no embryotoxicity or teratogenicity in rats or rabbits administered adefovir dipivoxil orally.
Croatian: Nije bilo učinaka na plodnost mužjaka ili ženki ili na uspjeh razmnožavanja štakora te nakon peroralne primjene adefovirdipivoksila u štakora i kunića nije zapažena embriotoksičnost ili teratogenost.
English: Tell a doctor or pharmacist if you are worried about any of these.
Croatian: Obavijestite svog liječnika ili ljekarnika ako Vas nešto od toga zabrinjava.
English: The dosing interval of adefovir dipivoxil should be adjusted in these patients (see section 4.2).
Croatian: U ovih pacijenata potrebno je prilagoditi interval doziranja adefovirdipivoksila (vidjeti dio 4.2).
English: Renal impairment: The mean (± SD) pharmacokinetic parameters of adefovir following administration of a single dose of 10 mg adefovir dipivoxil to patients with varying degrees of renal impairment are described in the table below:
Croatian: Oštećenje funkcije bubrega: Prosječni (± SD) farmakokinetički parametri adefovira nakon primjene pojedinačne doze 10 mg adefovirdipivoksila pacijentima s različitim stupnjem oštećenja funkcije bubrega opisani su u sljedećoj tablici.
English: However, mild to moderate increases in serum creatinine concentrations, hypophosphatemia and a decrease in carnitine concentrations were reported in 3 %, 4 % and 6 % of patients, respectively, on extended treatment.
Croatian: Međutim, blagi do umjereni porast koncentracije serumskog kreatinina zabilježen je u 3% pacijenata, hipofosfatemija u 4% pacijenata i smanjenje koncentracije karnitina u 6% pacijenata na produljenom liječenju.
English: • an open-label study in which pre- (n=226) and post-liver transplantation patients (n=241) with lamivudine-resistant HBV were treated with 10 mg adefovir dipivoxil once daily, for up to 203 weeks (median 51 and 99 weeks, respectively).
Croatian: • otvoreno ispitivanje u kojem su pacijenti prije (n=226) i nakon transplantacije jetre (n=241) s HBV-om rezistentnim na lamivudin bili liječeni s 10 mg adefovirdipivoksila jednom dnevno do 203. tjedna (medijan: 51. tjedan u prvoj odnosno 99. tjedan u drugoj skupini).
English: foscarnet, pentamidine, vancomycin, or medicinal products which are secreted by the same renal transporter, human Organic Anion Transporter 1 (hOAT1), such as cidofovir).
Croatian: humanim transporterom organskih aniona 1 (hOAT1) kao što je cidofovir).
English: Clinical resistance in patients receiving adefovir dipivoxil as monotherapy and in combination with lamivudine: In several clinical studies (HBeAg positive, HBeAg negative, pre- and post-liver transplantation with lamivudine-resistant HBV and lamivudine-resistant HBV co-infected with HIV patients), genotypic analyses were conducted on HBV isolates from 379 of a total of 629 patients, treated with adefovir dipivoxil for 48 weeks.
Croatian: Klinička rezistencija u pacijenata koji primaju adefovirdipivoksil kao monoterapiju te u kombinaciji s lamivudinom: U nekoliko kliničkih ispitivanja (HBeAg pozitivni pacijenti, HBeAg negativni pacijenti te pacijenti prije i nakon transplantacije jetre s HBV-om rezistentnim na lamivudin i pacijenti istovremeno zaraženi s HBV-om rezistentnim na lamivudin i HIV-om), provedene su analize genotipa HBV izolata u 379 od ukupno 629 pacijenata liječenih s adefovirdipivoksilom tijekom 48 tjedana.
English: No human data on the effect of adefovir dipivoxil on fertility are available.
Croatian: Nisu dostupni podaci o učinku adefovirdipivoksila na plodnost u ljudi.
English: Because of insufficient data on safety and efficacy, Hepsera should not be used in children under the age of 18 years (see Sections 4.2 and 5.1).
Croatian: Hepsera se ne smije primjenjivati u djece mlađe od 18 godina zbog nedostatnih podataka o sigurnosti primjene i djelotvornosti (vidjeti dio 4.2 i 5.1).
English: • Feeling sick (nausea) or being sick (vomiting) - common
Croatian: • mučninu ili povraćanje - često
English: DATE OF REVISION OF THE TEXT
Croatian: DATUM REVIZIJE TEKSTA {MM/GGGG}
English: Adefovir dipivoxil is a dipivaloyloxymethyl ester prodrug of the active substance adefovir, an acyclic nucleotide analogue which is actively transported into cells where it is converted by host enzymes to adefovir diphosphate.
Croatian: Adefovirdipivoksil je predlijek estera dipivaloiloksimetila djelatne tvari adefovira, acikličkog analoga nukleotida koji se aktivno transportira u stanice gdje ga enzimi stanice domaćina pretvaraju u adefovir difosfat.
English: Headache
Croatian: glavobolja
English: Treatment with adefovir dipivoxil may result in renal impairment.
Croatian: Liječenje adefovirdipivoksilom može uzrokovati oštećenje funkcije bubrega.
English: Blinded, ranked assessments of both necroinflammatory activity and fibrosis at baseline and week 48, demonstrated that patients treated with 10 mg adefovir dipivoxil had improved necro-inflammatory and fibrosis scores relative to placebotreated patients.
Croatian: Slijepa, rangirana procjena i nekro-upalne aktivnosti i fibroze na početku te u 48. tjednu pokazala je da su pacijenti liječeni s 10 mg adefovirdipivoksila imali poboljšane rezultate nekro-upalnih promjena i fibroze u odnosu na pacijente koji su primali placebo.
English: Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0) 24 01 35 50
Croatian: België/Belgique/Belgien Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0) 24 01 35 50
English: Contains lactose monohydrate, see package leaflet for further information.
Croatian: POPIS POMOĆNIH TVARI Sadrži laktozu hidrat, za više informacija vidjeti uputu o lijeku.
English: Adefovir dipivoxil is not recommended in patients with a creatinine clearance of < 30 ml/min or on dialysis.
Croatian: Adefovirdipivoksil ne preporučuje se u pacijenata s klirensom kreatinina < 30 ml/min ili onih na dijalizi.
English: Even though a pharmacokinetic interaction is unlikely given the two products are eliminated via different pathways, caution is recommended if both products are co-administered.
Croatian: Preporučuje se oprez kod istovremene primjene lijekova, iako farmakokinetička interakcija nije vjerojatna s obzirom na to da se ta dva lijeka uklanjanju različitim putevima.
English: Gilead Sciences Slovakia s.r.o.
Croatian: Česká republika Gilead Sciences s.r.o.
English: • Kidney problems, as shown by blood tests
Croatian: • problemi s bubrezima koji su vidljivi i u krvnim pretragama
English: Experience in patients with decompensated liver disease and lamivudine-resistant HBV: In 40 HBeAg positive or HBeAg negative patients with lamivudine-resistant HBV and decompensated liver disease receiving treatment with 100 mg lamivudine, addition of 10 mg adefovir dipivoxil treatment for 52 weeks resulted in a median reduction in HBV DNA of 4.6 log10 copies/ml.
Croatian: Iskustvo u pacijenata s dekompenziranom bolešću jetre i HBV-om rezistentnim na lamivudin: U 40 HBeAg pozitivnih ili HBeAg negativnih pacijenata s HBV-om rezistentnim na lamivudin i dekompenziranom bolešću jetre koji su primali terapiju sa 100 mg lamivudina, dodavanje 10 mg adefovirdipivoksila tijekom 52 tjedna liječenja dovelo je do medijana smanjenja HBV DNK za 4,6 log10 kopija/ml.
English: (may affect more than 1 in 10 people)
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba)
English: • A different dose may be given to patients with kidney problems.
Croatian: • Pacijenti s bolesnim bubrezima mogu primati drugačiju dozu.
English: Experience in patients with compensated liver disease and lamivudine-resistant HBV: In a double-blind comparative study in chronic hepatitis B patients with lamivudine-resistant HBV (n=58), there was no median reduction in HBV DNA from baseline after 48 weeks of treatment with lamivudine.
Croatian: Iskustvo u pacijenata s kompenziranom bolešću jetre i HBV-om rezistentnim na lamivudin: U dvostruko slijepom usporednom ispitivanju pacijenata s kroničnim hepatitisom B rezistentnim na lamivudin (n=58) nije bilo smanjenja medijana vrijednosti HBV DNK u odnosu na početne vrijednosti nakon 48 tjedana liječenja lamivudinom.
English: Clinical resistance in studies where adefovir dipivoxil was added to ongoing lamivudine in patients with lamivudine-resistance: In an open-label study of pre- and post-liver transplantation patients with clinical evidence of lamivudine-resistant HBV, no adefovir-associated resistance mutations were observed at week 48.
Croatian: Klinička rezistencija u ispitivanjima gdje je adefovirdipivoksil dodan postojećoj terapiji lamivudinom u pacijenata s rezistencijom na lamivudin: U otvorenom ispitivanju u pacijenata prije i nakon transplantacije jetre s kliničkim dokazanim HBV-om rezistentnim na lamivudin nisu uočene mutacije povezane s rezistencijom na adefovir u 48. tjednu.
English: Patients with a confirmed increase in creatinine of ≥ 0.3 mg/dl by week 48 were at a statistically significant higher risk of a subsequent confirmed increase in creatinine of ≥ 0.5 mg/dl. Hypophosphatemia and a decrease in carnitine concentrations were reported each in 3 % of patients on extended treatment.
Croatian: Pacijenti s potvrđenim povišenjem kreatinina za ≥ 0,3 mg/dl do 48. tjedna bili su pod statistički značajno višim rizikom od kasnije potvrđenog povišenja kreatinina za ≥ 0,5 mg/dl.
English: Experience in patients with compensated liver disease: In two placebo-controlled studies (total n=522) in HBeAg positive or in HBeAg negative chronic hepatitis B patients with compensated liver disease, significantly more patients (p < 0.001) in the 10 mg adefovir dipivoxil groups (53 and 64 %,
Croatian: Iskustva s pacijentima s kompenziranom bolešću jetre: U dva placebom kontrolirana ispitivanja (ukupan broj=522) u HBeAg pozitivnih i HBeAg negativnih pacijenata s kroničnim hepatitisom B i kompenziranom bolešću jetre, značajno je više pacijenata (p< 0,001) u skupinama koje su primale 10 mg adefovirdipivoksila (53 odnosno 64%) imalo histološko poboljšanje u 48. tjednu u odnosu na početne vrijednosti nego u skupinama koje su primale placebo (25 odnosno 33%).
English: Experience in patients pre- and post-liver transplantation with lamivudine-resistant HBV: In a clinical study in 394 chronic hepatitis B patients with lamivudine-resistant HBV (pre-liver transplantation (n=186) and post-liver transplantation (n=208)), treatment with 10 mg adefovir dipivoxil resulted in a median reduction in serum HBV DNA of 4.1 and 4.2 log10 copies/ml, respectively, at week 48.
Croatian: Iskustvo u pacijenata s HBV-om rezistentnim na lamivudin prije i nakon transplantacije jetre: U kliničkom ispitivanju u 394 pacijenata s kroničnim hepatitisom B rezistentnim na lamivudin (prije transplantacije jetre (n=186) te nakon transplantacije jetre (n=208)), liječenje s 10 mg adefovirdipivoksila rezultiralo je medijanom sniženja serumske HBV DNK za 4,1 odnosno 4,2 log10 kopija/ml u 48. tjednu.
English: Talk to your doctor before using Hepsera.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete Hepseru.
English: Each tablet contains 10 mg adefovir dipivoxil.
Croatian: Jedna tableta sadrži 10 mg adefovirdipivoksila.
English: Adefovir is excreted renally, by a combination of glomerular filtration and active tubular secretion.
Croatian: Adefovir se izlučuje bubrezima, kombinacijom glomerularne filtracije i aktivne tubularne sekrecije.
English: Hepatic function: Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT. After initiating antiviral therapy, serum ALT may increase in some patients as serum HBV DNA levels decline.
Croatian: Jetrena funkcija: Spontane egzacerbacije kroničnog hepatitisa B relativno su česte te ih karakterizira prolazni porast serumskog ALT-a.
English: • The active substance in Hepsera is adefovir dipivoxil.
Croatian: Što Hepsera sadrži - Djelatna tvar Hepsere je adefovirdipivoksil.
English: Renal Function Group
Croatian: Skupina prema funkciji bubrega
English: • Rash and itching - common
Croatian: • osip i svrbež - često
English: Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill Co. Cork Ireland
Croatian: Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill Co.
English: PC: {number} SN: {number} NN: {number}
Croatian: SN: {broj}
English: Elimination: Adefovir is excreted renally by a combination of glomerular filtration and active tubular secretion.
Croatian: Eliminacija: Adefovir se izlučuje bubrezima, kombinacijom glomerularne filtracije i aktivne tubularne sekrecije.
English: Pregelatinised starch Croscarmellose sodium Lactose monohydrate Talc
Croatian: 6.1 Popis pomoćnih tvari škrob, prethodno geliran karmelozanatrij, umrežena laktoza hidrat talk magnezijev stearat
English: Experience in patients with HIV co-infection and lamivudine-resistant HBV: In an open-label investigator study in 35 chronic hepatitis B patients with lamivudine-resistant HBV and co-infected with HIV, continued treatment with 10 mg adefovir dipivoxil resulted in progressive reductions in serum HBV DNA levels and ALT levels throughout the course of treatment up to 144 weeks.
Croatian: Iskustvo u pacijenata istovremeno zaraženih HIV-om i HBV-om rezistentnim na lamivudin: U otvorenom ispitivanju u 35 kroničnih pacijenata s HBV-om rezistentnim na lamivudin i istovremeno zaraženih HIV-om, nastavak liječenja s 10 mg adefovirdipivoksila doveo je do progresivnog sniženja serumskih razina HBV DNK te razina ALT-a tijekom trajanja liječenja do 144 tjedna.
English: • Headache
Croatian: • glavobolja
English: Osteomalacia (manifested as bone pain and infrequently contributing to fractures) and myopathy, both associated with proximal renal tubulopathy Renal and urinary disorders: Very common:
Croatian: osteomalacija (očituje se kao bol u kostima te nerijetko pridonosi prijelomima) i miopatija, koje su obje povezane s proksimalnom bubrežnom tubulopatijom
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet:
English: Unimpaired
Croatian: Doziranje
English: Renal function: Adefovir is excreted renally, by a combination of glomerular filtration and active tubular secretion.
Croatian: Bubrežna funkcija: Adefovir se izlučuje bubrezima, kombinacijom glomerularne filtracije i aktivne tubularne sekrecije.
English: Two novel conserved site mutations were identified in the HBV polymerase gene (rtN236T and rtA181V), which conferred clinical resistance to adefovir dipivoxil.
Croatian: (rtN236T i rtA181V) prenijela su kliničku rezistenciju na adefovirdipivoksil.
English: • Stomach pain
Croatian: • bol u trbuhu
English: In the pre-liver transplantation and post-liver transplantation cohorts 77 of 109 (71 %) patients and 64 of 159 (40 %) patients, respectively, achieved undetectable HBV DNA levels at week 48 (< 1,000 copies/ml Roche Amplicor Monitor PCR assay).
Croatian: Razina HBV DNK postala je nemjerljiva u 48. tjednu (< 1000 kopija/ml prema PCR testu Roche Amplicor Monitor) u 77 od 109 (71%) pacijenata u kohorti prije transplantacije jetre i 64 od 159 (40%) pacijenata u kohorti nakon transplantacije jetre.
English: Magnesium stearate
Croatian: Tablični sažetak nuspojava
English: The potential for CYP450 mediated interactions involving adefovir with other medicinal products is low, based on the results of in vitro experiments in which adefovir did not influence any of the common CYP isoforms known to be involved in human drug metabolism and based on the known elimination pathway of adefovir.
Croatian: Na temelju rezultata in vitro pokusa u kojima adefovir nije utjecao ni na jedan od izooblika CYP enzima za koje se zna da obično sudjeluju u metabolizmu lijekova u ljudi te na temelju poznatog puta eliminacije adefovira, mogućnost interakcija posredovanih citokromom P450 (CYP450) adefovira s drugim lijekovima je niska.
English: Adefovir diphosphate selectively inhibits HBV DNA polymerases at concentrations 12-,
Croatian: Adefovir difosfat selektivno inhibira HBV DNK polimeraze u koncentracijama 12, 700 odnosno 10 puta nižim od onih koje su potrebne za inhibiciju humane DNK polimeraze α, β odnosno γ.
English: Asthenia c. Description of selected adverse reactions
Croatian: Opis odabranih nuspojava
English: (may affect up to 1 in 10 people)
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba)
English: • Use an effective method of contraception to avoid becoming pregnant if you are a woman of child-bearing age taking Hepsera.
Croatian: • Ako ste žena u generativnoj dobi koja uzima Hepseru, upotrebljavajte učinkovite metode kontracepcije.
English: 30 tablets.
Croatian: OBLIK I SADRŽAJ 30 tableta.
English: (may affect up to 1 in 100 people) • Damage to kidney tubule cells
Croatian: • oštećenje stanica bubrežnih kanalića Česte nuspojave (mogu se javiti u do 1 na 10 osoba)
English: BATCH NUMBER
Croatian: 13. BROJ SERIJE Lot
English: Gilead Sciences Poland Sp. z o.o.
Croatian: Gilead Sciences Netherlands B.V.
English: (may affect up to 1 in 10,000 people)
Croatian: Vrlo rijetke nuspojave (mogu se javiti u manje od 1 na 10 000 osoba)
English: However, a signal towards a higher rate of decreased appetite and/or food intake was observed in the adefovir arm as compared to the placebo arm. At week 48 and 96, mean changes from baseline in weight and BMI Z scores tended to decrease in adefovir dipivoxil-treated patients.
Croatian: Međutim, primijećen je signal s obzirom na veću stopu smanjenja apetita i/ili smanjenog unosa hrane u skupini koja je primala adefovir u usporedbi sa skupinom koja je primala placebo.
English: Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1849
Croatian: Suomi/Finland Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1849
English: Gastrointestinal disorders: Common:
Croatian: Poremećaji probavnog sustava: Često:
English: Tel: + 34 91 378 98 30
Croatian: Gilead Sciences, S.L. Tel: + 34 91 378 98 30
English: PHARMACEUTICAL FORM AND CONTENTS
Croatian: FARMAKOLOŠKA SVOJSTVA
English: Uncommon:
Croatian: Manje često:
English: • Diarrhoea
Croatian: • mučnina
English: • Feeling sick (nausea) and sickness (vomiting)
Croatian: • mučnina i povraćanje
English: • Kidney failure - common
Croatian: • zatajenje bubrega - često
English: Deutschland
Croatian: Irska
English: Strength Pharmaceutical Form
Croatian: Farmaceutski oblik
English: Immediate Packaging Pack size
Croatian: Put primjene Unutarnje pakovanje
English: (Invented) name
Croatian: (Zaštićeno) ime Doza
English: It is given once every three weeks as an infusion lasting 10 minutes.
Croatian: Primjenjuje se jednom svaka tri tjedna kao infuzija koja traje 10 minuta.
English: The recommended dose is 500 mg per square metre of body surface area (calculated using the patient's height and weight).
Croatian: Preporučena doza iznosi 500 mg po kvadratnom metru tjelesne površine (izračunato temeljem visine i tjelesne težine bolesnika).
English: The name of the medicine was changed to Armisarte on 10 February 2016.
Croatian: Naziv lijeka izmijenjen je u Armisarte 10. veljače 2016.
English: The full EPAR and risk management plan summary for Armisarte can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Armisarte nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Armisarte is a ‘hybrid medicine'.
Croatian: Armisarte je „hibridni lijek”.
English: Previously known as Pemetrexed Actavis.
Croatian: Ranije poznat pod imenom Pemetrexed Actavis
English: This summary was last updated in 02-2016.
Croatian: Ovaj sažetak je posljednji put ažuriran u 02.2016.
English: The company provided data from the published literature on pemetrexed.
Croatian: Tvrtka je priložila podatke iz objavljene literature o pemetreksedu.
English: It can also be used as a maintenance treatment in patients who have received a platinum-based chemotherapy.
Croatian: Može se također koristiti kao terapija održavanja u bolesnika koji su primili kemoterapiju baziranu na platini.
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Croatian: Cjeloviti EPAR za referentni lijek također se nalazi na internetskim stranicama Agencije.
English: Armisarte is a cancer medicine used to treat two types of lung cancer:
Croatian: Armisarte je lijek protiv raka koji se koristi za liječenje dvaju tipova raka pluća:
English: This means that Armisarte is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta, but it is available in a different form.
Croatian: To znači da je Armisarte sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Alimta, ali je dostupan u drugom obliku.
English: What is Armisarte and what is it used for?
Croatian: Što je Armisarte i za što se koristi?
English: Why is Armisarte approved?
Croatian: Zašto je Armisarte odobren?
English: What are the benefits and risks of Armisarte?
Croatian: Koje su koristi i rizici lijeka Armisarte?
English: What measures are being taken to ensure the safe and effective use of Armisarte?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Armisarte?
English: Other information about Armisarte
Croatian: Ostale informacije o lijeku Armisarte
English: This is a summary of the European public assessment report (EPAR) for Armisarte.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Armisarte.
English: A risk management plan has been developed to ensure that Armisarte is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Armisarte.
English: The medicine can only be obtained with a prescription and should only be given under the supervision of a doctor who is qualified in the use of cancer medicines.
Croatian: Ovaj se lijek izdaje samo na liječnički recept i smije se primjenjivati samo pod nadzorom liječnika koji ima iskustva u primjeni lijekova protiv raka.
English: It is not intended to provide practical advice on how to use Armisarte.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Armisarte.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pemetrexed Actavis on 18 January 2016.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Pemetrexed Actavis na snazi u Europskoj uniji od 18. siječnja 2016.