FrancophonIA/ELRC3.0 huggingface dataset:
English: A multicentre, randomised, open-label, Phase 3 study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that pemetrexed plus cisplatin (Intent-To-Treat [ITT] population n=862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT n=863) in overall survival (adjusted hazard ratio 0.94; 95 % CI=0.84-1.05).
Slovenian: Multicentrična, randomizirana, odprta študija faze 3 pemetrekseda skupaj s cisplatinom proti gemcitabinu skupaj s cisplatinom pri bolnikih, ki v preteklosti še niso prejemali kemoterapije, z lokalno napredovalim ali metastatskim (stopnja IIIb ali IV) nedrobnoceličnim karcinomom pljuč (NSCLC), je pokazala, da je pemetreksed skupaj s cisplatinom (Populacija z namenom zdraviti, [NZ] populacija n = 862) dosegla prvotno končno točko in pokazala podobno klinično učinkovitost, kot gemcitabin skupaj s cisplatinom (NZ n = 863) v skupnem preživetju (prilagojeno razmerje tveganja 0,94; 95 % IZ = 0,84-1,05).
English: Pemetrexed/cisplatin
Slovenian: Pemetreksed/ cisplatin
English: Following pemetrexed plus cisplatin induction (4 cycles), treatment with pemetrexed was statistically superior to placebo for OS (median 13.9 months versus 11.0 months, hazard ratio=0.78, 95 %CI=0.640.96, p=0.0195).
Slovenian: Po indukcijskem zdravljenju pemetreksedom skupaj s cisplatinom (4 cikli) je bilo zdravljenje s pemetreksedom statistično boljše od placeba glede skupnega preživetja (mediana 13,9 mesecev v primerjavi z 11,0 meseci, razmerje tveganja = 0,78, 95 % CI=0,64-0,96, p=0,0195).
English: Median HR (95 % CI)
Slovenian: RT (95 % IZ)
English: Table 1 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin - Haematologic toxicities
Slovenian: Preglednica 1 - Preglednica za prilagajanje odmerkov pemetrekseda (kot edine učinkovine ali v kombinaciji) in cisplatina - Hematološke toksičnosti
English: - if you are breast-feeding; you must discontinue breast-feeding during treatment with Armisarte.
Slovenian: - če dojite, morate med zdravljenjem z zdravilom Armisarte dojenje prekiniti.
English: Table 3 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin - Neurotoxicity
Slovenian: Preglednica 3 - Preglednica za prilagajanje odmerkov pemetrekseda (kot edine učinkovine ali v kombinaciji) in cisplatina - Nevrotoksičnost
English: Pemetrexed*** (N=800)
Slovenian: Pemetreksed*** N = 800
English: Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis) - If you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common) - If you experience bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common) - If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (uncommon)(may indicate a blood clot in the blood vessels of the lungs)
Slovenian: - Če vam krvavijo dlesni, krvavite iz nosu ali ustne votline, ali se pojavi kakršnakoli krvavitev, ki se noče ustaviti, rdečkasto ali rožnato obarvan urin, nepričakovane podplutbe (ker imate lahko manj trombocitov, kot je normalno, kar je zelo pogosto).
English: 50% of previous dose (both pemetrexed and cisplatin) a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Slovenian: 50 % predhodnega odmerka (obeh pemetrekseda in cisplatina) Ta merila ustrezajo Merilom pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (National Cancer Institute Common Toxicity Criteria, CTC v2.0; NCI 1998), definiciji za ≥ CTC stopnjo krvavitve 2
English: Pemetrexed in combination with cisplatin The recommended dose of pemetrexed is 500 mg/m2 of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Slovenian: Priporočeni odmerek pemetrekseda je 500 mg/m2 telesne površine (TP), dan kot intravenska infuzija v 10 minutah prvi dan vsakega 21-dnevnega ciklusa.
English: The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5 % of 800 patients randomly assigned to receive single agent pemetrexed and 402 patients randomly assigned to receive placebo in the single-agent pemetrexed maintenance (JMEN: N=663) and continuation pemetrexed maintenance (PARAMOUNT: N=539) studies.
Slovenian: Spodnja preglednica podaja pogostnost in izraženost neželenih učinkov, ki so jih ocenili kot možno povezane s študijskim zdravilom, o katerih so poročali pri > 5 % od 800 bolnikov z nedrobnoceličnim karcinomom pljuč, ki so naključno prejemali pemetreksed kot edino zdravilo, in 402 bolnikov, ki so naključno prejemali placebo v študijah vzdrževalnega zdravljenja samo s pemetreksedom (JMEN: N=663) ter nadaljevalnega zdravljenja s pemetreksedom (PARAMOUNT: N=539).
English: PARAMOUNT:Kaplan Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation pemetrexed maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation)
Slovenian: PARAMOUNT: Kaplan Meier-jev graf preživetja brez napredovanja in skupnega preživetja za nadaljevanje vzdrževalnega zdravljenja s pemetreksedom v primerjavi s placebom pri bolnikih z nedrobnoceličnim karcinomom pljuč, ki nima pretežno ploščatocelične histologije (merjeno od randomizacije)
English: 50% of previous dose a
Slovenian: 50 % predhodnega odmerka
English: Table 2 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin- Non-haematologic toxicitiesa,b
Slovenian: Preglednica 2 - Preglednica za prilagajanje odmerkov pemetrekseda (kot edine učinkovine ali v kombinaciji) in cisplatina - Nehematološke toksičnosti a, b
English: (N=519), and compared to patients who received > 6 cycles of pemetrexed (N=281).
Slovenian: Pojavnost neželenih učinkov so ocenili za bolnike, ki so prejeli ≤ 6 ciklov vzdrževalnega zdravljenja s pemetreksedom (N=519) in jo primerjali z bolniki, ki so prejeli > 6 ciklov pemetrekseda (N=281).
English: 50% of previous dose 100% of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Slovenian: 100 % predhodnega odmerka 50 % predhodnega odmerka a *Merila pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (CTC v2.0; NCI 1998)
English: The median OS for the overall population (n=663) was 13.4 months for the pemetrexed arm and 10.6 months for the placebo arm, hazard ratio=0.79 (95% CI=0.65-0.95, p=0.01192).
Slovenian: Mediana skupnega preživetja za celotno populacijo (n = 663) je bila 13,4 mesece za skupino s pemetreksedom in 10,6 mesecev za skupino s placebom, razmerje tveganja = 0,79 (95 % CI: 0,65 do 0,95; p = 0,01192).
English: Survival Time (months) Median (m) 95 % CI for median HR 95 % CI for HR Non-inferiority p-value (HR)
Slovenian: Čas preživetja (meseci) Mediana (m) 95 % IZ za mediano
English: Pemetrexed in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Slovenian: Pemetreksed je v kombinaciji s cisplatinom indiciran kot zdravljenje prvega izbora za bolnike z lokalno napredovalim ali metastatskim nedrobnoceličnim karcinomom pljuč, ki nima pretežno ploščatocelične histologije (glejte poglavje 5.1).
English: Armisarte 25 mg/ml sterile concentrate pemetrexed
Slovenian: Armisarte 25 mg/ml sterilni koncentrat pemetreksed i.v.
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (n=581, independently reviewed population; median of 4.0 months and 2.0 months, respectively) (hazard ratio=0.60, 95% CI=0.49-0.73, p<0.00001).
Slovenian: Študija je dosegla svojo primarno končno točko in pokazala statistično značilno izboljšanje preživetja brez napredovanja v skupini s pemetreksedom glede na skupino s placebom (n = 581, neodvisno pregledana populacija; mediana 4,0 mesece in 2,0 meseca) (razmerje tveganja = 0,60, 95 % CI: 0,490,73, p < 0,00001).
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (n=472, independently reviewed population; median of 3.9 months and 2.6 months, respectively) (hazard ratio=0.64, 95 % CI=0.51-0.81, p=0.0002).
Slovenian: Študija je dosegla svoj primarni ciljni učinek in dokazala statistično pomembno izboljšanje preživetja brez napredovanja bolezni v skupini, ki je prejemala pemetreksed, v primerjavi s skupino, ki je prejemala placebo (n = 472, neodvisno pregledana populacija; mediano 3,9 meseca in 2,6 meseca) (razmerje tveganja=0,64, 95 % CI = 0,51-0,81, p = 0,0002).
English: Pemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Slovenian: Pemetreksed je v kombinaciji s cisplatinom indiciran za zdravljenje bolnikov z neresektabilnim malignim plevralnim mezoteliomom, ki jih še nismo zdravili s kemoterapijo.
English: Cytotoxic Must only be diluted in 5% glucose solution.
Slovenian: Sme se razredčiti le s 5 % raztopino glukoze.
English: Very common (may affect more than 1 in 10 people) - Low white blood cells - Low haemoglobin level (anaemia) - Low platelet count - Diarrhoea - Vomiting - Pain, redness, swelling or sores in your mouth - Nausea - Loss of appetite - Fatigue (tiredness) - Skin rash, peeling of the skin - Hair loss - Constipation - Loss of sensation - Kidney: abnormal blood tests
Slovenian: - nizko število belih krvnih celic - nizka raven hemoglobina (anemija) - nizko število trombocitov - diareja - bruhanje - bolečina, rdečina, otekanje ali rane v vaših ustih - slabost - izguba apetita
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Armisarte Vsebina pakiranja in dodatne informacije
English: N=229 1.23 Abbreviations: CI = confidence interval; ITT = intent-to-treat; N = total population size.
Slovenian: Okrajšave: IZ = interval zaupanja; NZ = namen zdraviti; N = velikost populacije.
English: Pemetrexed is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Slovenian: Pemetreksed je indiciran kot monoterapija za zdravljenje drugega izbora bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim karcinomom, ki nima pretežno ploščatocelične histologije (glejte poglavje 5.1).
English: For the purpose of this table a cut off of 5% was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed and cisplatin.
Slovenian: Za namen te preglednice smo uporabili »cut off« 5 % za vključitev vseh dogodkov, kjer je poročevalec upošteval možno povezavo pemetrekseda in cisplatina.
English: From the start of pemetrexed plus cisplatin first line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio=0.78, 95 % CI=0.64-0.96).
Slovenian: Od začetka indukcijskega zdravljenja prve izbire s pemetreksedom skupaj s cisplatinom je bilo mediano skupno preživetje bolnikov 16,9 meseca v kraku pemetrekseda in 14,0 mesecev v kraku s placebom (razmerje tveganja = 0,78, 95% % CI = 0,64-0,96).
English: For patients with NSCLC other than predominantly squamous cell histology (n=430, independently reviewed population) median PFS was 4.4 months for the pemetrexed arm and 1.8 months for the placebo arm, hazard ratio=0.47 (95% CI=0.37-0.60, p=0.00001).
Slovenian: Za bolnike z NSCLC , ki nima pretežno ploščatocelične histologije (n = 430, neodvisno pregledana populacija) je bila mediana preživetja brez napredovanja 4,4 mesece za skupino s pemetreksedom in 1,8 meseca za skupino s placebom, razmerje tveganja = 0,47, 95 %CI: 0,37-0,60, p = 0,00001).
English: Hemoglobin decreased
Slovenian: Znižan hemoglobin Pogosto Znižani trombociti
English: Common Vomiting Mucositis/ stomatitis
Slovenian: Pogosto Bruhanje Mukozitis/Sto matitis
English: radiation therapy - Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding) - Interstitial pneumonitis (scarring of the air sacs of the lung) - Oedema (excess fluid in body tissue, causing swelling) - Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving pemetrexed usually in combination with another anticancer therapy - Pancytopenia- combined low counts of white cells, red cells and platelets - Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy)
Slovenian: - edem (preveč tekočine v telesnih tkivih, kar povzroča oteklino) - nekateri bolniki so med prejemanjem pemetrekseda, običajno v kombinaciji z drugim zdravilom proti raku, doživeli srčno kap, možgansko kap ali "manjšo kap".
English: Including the induction phase the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio=0.71 (95 % CI=0.56-0.88, p=0.002).
Slovenian: Vključno z indukcijsko fazo je bila mediana skupnega preživetja za bolnike z NSCLC, ki nima pretežno ploščatocelične histologije 18,6 mesecev za skupino s pemetreksedom in 13,6 mesecev za skupino s placebom (razmerje tveganja = 0,71, 95% CI: 0,56-0,88, p = 0,002).
English: National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Slovenian: 100 % predhodnega odmerka a Merila pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (CTC v2.0; NCI 1998)
English: Women must use effective contraception during treatment with Armisarte.
Slovenian: Med zdravljenjem z zdravilom Armisarte morajo ženske uporabljati učinkovito metodo kontracepcije.
English: Clinically relevant CTC toxicity of any grade that was reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritis/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Slovenian: Klinično pomembne toksičnosti, o katerih so poročali pri > 1 % in ≤ 5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: febrilno nevtropenijo, infekcijo, znižane trombocite, diarejo, zaprtje, alopecijo, srbenje, vročino (v odsotnosti nevtropenije), bolezni površine očesa (vključno s konjunktivitisom), povečano solzenje, omotico in motorično nevropatijo.
English: The independent review of patient scans confirmed the findings of the investigator assessment of PFS. For randomised patients, as measured from the start of pemetrexed plus cisplatin first line induction treatment, the median investigator-assessed PFS was 6.9 months for the pemetrexed arm and 5.6 months for the placebo arm (hazard ratio = 0.59 95 % CI=0.47-0.74).
Slovenian: Za naključno izbrane bolnike, merjeno od začetka zdravljenja s pemetreksedom in indukcijskim zdravljenjem prve izbire s cisplatinom, je bilo mediano preživetje brez napredovanja bolezni po oceni raziskovalca 6,9 meseca za skupino, ki je prejemala pemetreksed, in 5,6 meseca za skupino, ki je prejemala placebo (razmerje tveganja = 0,59 95 % CI = 0,47-0,74).
English: The concentrate is clear, colourless to slightly yellowish or yellow-greenish solution.
Slovenian: koncentrat za raztopino za infundiranje (sterilni koncentrat) Koncentrat je bistra, brezbarvna do rahko rumenkasta ali rumeno-zelenkasta raztopina.
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (n=481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio=0.70 (95 % CI = 0.56-0.88, p = 0.002).
Slovenian: Mediana skupnega preživetja za bolnike z NSCLC, ki nima pretežno ploščatocelične histologije (n = 481) je bila 15,5 mesecev za skupino s pemetreksedom in 10,3 mesecev za skupino s placebom (razmerje tveganja = 0,70, 95 % CI: 0,56-0,88, p = 0,002).
English: Armisarte 25 mg/ml concentrate for solution for infusion
Slovenian: Armisarte 25 mg/ml koncentrat za raztopino za infundiranje
English: Common (may affect up to 1 in 10 people) - Allergic reaction: skin rash / burning or prickling sensation - Infection including sepsis - Fever - Dehydration - Kidney failure - Irritation of the skin and itching - Hives - Increased skin pigmentation - Chest pain - Muscle weakness - Conjunctivitis (inflamed eye) - Upset stomach - Pain in the abdomen - Taste change - Liver: abnormal blood tests - Watery eyes - Dizziness
Slovenian: - bolečina v prsnem košu - mišična oslabelost - konjunktivitis (vnetje očesa) - razdražen želodec - bolečina v trebuhu - sprememba okusa - jetra: nenormalne vrednosti krvnih testov - solzne oči - omotica
English: Use aseptic techniques during dilution of pemetrexed for intravenous infusion administration.
Slovenian: Pri redčenju pemetrekseda za intravensko infundiranje uporabljajte aseptično metodo.
English: Armisarte 25 mg/ml concentrate for solution for infusion pemetrexed
Slovenian: Armisarte 25 mg/ml koncentrat za raztopino za infundiranje pemetreksed
English: Nadir ANC < 500/mm3 and nadir platelets
Slovenian: Najnižji ANC < 500 /mm3 in najnižje število trombocitov ≥ 50.000 /mm3
English: It contains the active substance pemetrexed.
Slovenian: Zdravilo vsebuje zdravilno učinkovino pemetreksed.
English: One vial of 34 ml concentrate contains 850 mg pemetrexed (as pemetrexed diacid).
Slovenian: Ena viala s 34 ml koncentrata vsebuje 850 mg pemetrekseda (v obliki dvokislinskega pemetrekseda).
English: One ml of concentrate contains 25 mg pemetrexed (as pemetrexed diacid).
Slovenian: En ml koncentrata vsebuje 25 mg pemetrekseda (v obliki dvokislinskega pemetrekseda).
English: One vial of 4 ml contains 100 mg pemetrexed (as pemetrexed diacid).
Slovenian: Ena 4 ml viala vsebuje 100 mg pemetrekseda (v obliki dvokislinskega pemetrekseda).
English: One vial of 34 ml contains 850 mg pemetrexed (as pemetrexed diacid).
Slovenian: Ena 34 ml viala vsebuje 850 mg pemetrekseda (v obliki dvokislinskega pemetrekseda).
English: One vial of 20 ml contains 500 mg pemetrexed (as pemetrexed diacid).
Slovenian: Ena 20 ml viala vsebuje 500 mg pemetrekseda (v obliki dvokislinskega pemetrekseda).
English: Trometamol (for pH adjustment) Anhydrous citric acid Methionine
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi trometamol (za uravnavanje pH) brezvodna citronska kislina metionin voda za injekcije
English: Infection (sepsis) may be severe and could lead to death - If you start feeling chest pain (common) or having a fast heart rate (uncommon) - If you have pain, redness, swelling or sores in your mouth (very common) - Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common).
Slovenian: - Alergijska reakcija: če se pojavi izpuščaj (zelo pogosto) / pekoč ali zbadajoč občutek (pogosto), ali povišana telesna temperatura (pogosto).
English: Your dose may be changed or treatment delayed depending on results from these tests.
Slovenian: Od rezultatov preiskav je odvisno, ali je odmerek morda potrebno prilagoditi ali odložiti zdravljenje.
English: Talk to your doctor or hospital pharmacist before receiving Armisarte.
Slovenian: Pred začetkom uporabe zdravila Armisarte se posvetujte z zdravnikom ali bolnišničnim farmacevtom.
English: One vial of 20 ml concentrate contains 500 mg pemetrexed (as pemetrexed diacid).
Slovenian: Ena viala z 20 ml koncentrata vsebuje 500 mg pemetrekseda (v obliki dvokislinskega pemetrekseda).
English: One vial of 4 ml concentrate contains 100 mg pemetrexed (as pemetrexed diacid).
Slovenian: Ena viala s 4 ml koncentrata vsebuje 100 mg pemetrekseda (v obliki dvokislinskega pemetrekseda).
English: Pemetrexed/ cisplatin (N=839)
Slovenian: Organski sistem Pogostnost Dogodek** Pemetreksed/cisplatin N = 839
English: One vial of 40 ml concentrate contains 1000 mg pemetrexed (as pemetrexed diacid).
Slovenian: Ena viala s 40 ml koncentrata vsebuje 1000 mg pemetrekseda (v obliki dvokislinskega pemetrekseda).
English: One ml contains 25 mg pemetrexed (as pemetrexed diacid).
Slovenian: En ml vsebuje 25 mg pemetrekseda (v obliki dvokislinskega pemetrekseda).
English: Package leaflet: Information for the user Armisarte 25 mg/ml concentrate for solution for infusion pemetrexed
Slovenian: Navodilo za uporabo Armisarte 25 mg/ml koncentrat za raztopino za infundiranje pemetreksed
English: One vial of 40 ml contains 1000 mg pemetrexed (as pemetrexed diacid).
Slovenian: Ena 40 ml viala vsebuje 1000 mg pemetrekseda (v obliki dvokislinskega pemetrekseda).
English: Diarrhoea
Slovenian: Bolezni
English: Mesothelioma
Slovenian: Adenocarcinoma
English: Pemetrexed at a dose of 500 mg/m2 was studied as a single-agent in 64 chemonaive patients with malignant pleural mesothelioma.
Slovenian: Pemetreksed kot edino učinkovino so preučevali v odmerku 500 mg/m2 pri
English: Pemetrexed as single agent
Slovenian: Pemetreksed kot samostojno zdravilo
English: Cisplatin (N=222)
Slovenian: (N = 222)
English: Common Neuropathysensory
Slovenian: Pogosto Nevropatijasenzorna
English: You might have any of these symptoms and/or conditions.
Slovenian: - hipernatriemija - zvišana raven natrija v krvi Pojavi se lahko katerikoli od teh simptomov in/ali stanj.
English: IV
Slovenian: Edem
English: - Bullous conditions (blistering skin diseases)-including Stevens-Johnson syndrome and Toxic epidermal necrolysis - Immune mediated haemolytic anaemia (antibody-mediated destruction of red blood cells) - Hepatitis (inflammation of the liver) - Anaphylactic shock (severe allergic reaction)
Slovenian: - imunsko pogojena hemolitična anemija (propad rdečih krvnih celic, ki ga povzročijo protitelesa)
English: 14 May 2013
Slovenian: 14. maj 2013
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC
Slovenian: Izid postopka po členu 29 Direktive 2001/83/ES
English: The European Commission issued a decision on 14 May 2013.
Slovenian: Evropska komisija je odločbo izdala dne 14. maja 2013.
English: After re-examination, the Committee confirmed these recommendations on 18 February 2013.
Slovenian: Po ponovnem pregledu je Odbor potrdil svoja priporočila dne 18. februarja 2013.
English: It was to be available as tablets (40 mg).
Slovenian: Na voljo naj bi bilo v obliki tablet (40 mg).
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Estonia) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Czech Republic, Denmark, Finland, Hungary, Latvia, Lithuania, Norway, Poland, Slovakia, Slovenia and Sweden).
Slovenian: To je postopek, pri katerem ena od držav članic („referenčna država članica‟, v tem primeru Estonija) oceni zdravilo z namenom odobritve dovoljenja za promet z njim, ki bo veljavno v tej državi in v drugih državah članicah (v „zadevnih državah članicah‟, v tem primeru v Češki republiki, na Danskem, Finskem, Madžarskem, v Latviji, Litvi, na Norveškem, Poljskem, Slovaškem, v Sloveniji in na Švedskem).
English: It works in the kidneys by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.
Slovenian: Furosemid deluje v ledvicah tako, da poveča izločanje urina, zmanjša količino tekočine v krvi in zniža krvni tlak.