FrancophonIA/ELRC3.0 huggingface dataset:
English: A ready-to-use solution is prepared by injecting 10 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection into the vial containing the dry powder.
Slovenian: Raztopino za injiciranje pripravimo z injiciranjem 10 ml raztopine natrijevega klorida 9 mg/ml (0,9%) za injiciranje v vialo, ki vsebuje suhi prašek.
English: Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach.
Slovenian: - sindroma Zollinger-Ellison in drugih stanj s povečanim izločanjem želodčne kisline.
English: For the long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much stomach acid is produced.
Slovenian: za dolgotrajno zdravljenje Zollinger-Ellisonovega sindroma in drugih stanj s povečanim izločanjem želodčne kisline
English: Use the reconstituted solution within 12 hours.
Slovenian: Pripravljeno raztopino uporabite v 12 urah.
English: A ready-to-use solution is prepared by injecting 10 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection into the vial containing the powder.
Slovenian: Raztopino za injiciranje pripravimo z injiciranjem 10 ml raztopine natrijevega klorida 9 mg/ml (0,9%) za injiciranje v vialo, ki vsebuje prašek.
English: Germany Greece
Slovenian: Grčija
English: This solution may either be administered directly or after mixing it with 100 ml sodium chloride 9 mg/ml (0.9 %) solution for injection or glucose 55 mg/ml (5 %) solution for injection.
Slovenian: To raztopino lahko injiciramo bodisi neposredno ali po mešanju s 100 ml raztopine natrijevega klorida 9 mg/ml (0,9%) za injiciranje ali raztopino glukoze 55 mg/ml (5%) za injiciranje.
English: Protium and associated names (see Annex I) 40 mg powder for solution for injection [See Annex I - To be completed nationally]
Slovenian: Protium in z njim povezana imena (Glejte Dodatek I) 40 mg prašek za raztopino za injiciranje [Glejte Dodatek I - Izpolni država članica]
English: Consult your doctor or pharmacist.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Vial Label
Slovenian: PODATKI NA PRIMARNI OVOJNINI Nalepka viale
English: Protium should not be prepared or mixed with solvents other than those stated.
Slovenian: Zdravila Protium 40 mg prašek za raztopino za injiciranje se ne sme pripraviti ali mešati z drugimi kot tukaj navedenimi topili.
English: Treatment of gastric ulcer
Slovenian: Za zdravljenje refluksnega ezofagitisa
English: Protium should not be used during pregnancy unless clearly necessary.
Slovenian: Zdravila Protium 40 mg prašek za raztopino za injiciranje ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
English: General pharmacokinetics
Slovenian: Splošna farmakokinetika
English: Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
Slovenian: Vsaka gastrorezistentna tableta vsebuje 20 mg pantoprazola v obliki natrijevega pantoprazolata seskvihidrata.
English: Hospital pack with 50, 56, 84, 90, 112, 140, 140 (10x14 or 5x28), 150 (10x15), 280 (20x14 or 10x28), 500, 700 (5x140) gastro-resistant tablets.
Slovenian: Bolnišnično pakiranje s 50, 56, 84, 90, 112, 140, 140 (10x14 ali 5x28), 150 (10x15), 280 (20x14 ali 10x28), 500, 700 (5x140) gastrorezistentnimi tabletami.
English: This solution may be administered directly or may be administered after mixing it with 100 ml sodium chloride 9 mg/ml (0.9 %) solution for injection or glucose 55 mg/ml (5 %) solution for injection.
Slovenian: To raztopino lahko injiciramo neposredno ali pa po mešanju s 100 ml raztopine natrijevega klorida 9 mg/ml (0,9%) za injiciranje ali raztopino glukoze 55 mg/ml (5%) za injiciranje.
English: Injection site thrombophlebitis
Slovenian: Učinek pantoprazola na absorpcijo drughi zdravil
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 40 mg of pantoprazole (as sodium sesquihydrate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 40 mg pantoprazola v obliki natrijevega pantoprazolata seskvihidrata.
English: Intravenous administration of Protium is recommended only if oral administration is not appropriate.
Slovenian: Intravensko dajanje zdravila Protium 40 mg prašek za raztopino za injiciranje je priporočljivo le, če peroralno dajanje ni primerno.
English: Hepatocellular injury; Jaundice; Hepatocellular failure
Slovenian: povišan bilirubin poškodba jeter; zlatenica; odpoved jeter
English: The prepared solution may be administered directly or may be administered after mixing it with 100 ml sodium chloride 9 mg/ml (0.9 %) solution for injection or glucose 55 mg/ml (5 %) solution for injection.
Slovenian: Pripravljeno raztopino lahko dajemo neposredno ali jo razredčimo s 100 ml raztopine natrijevega klorida 9 mg/ml (0,9%) za injiciranje ali raztopino glukoze 55 mg/ml (5%) za injiciranje.
English: Hospital pack with 50, 90, 100, 140, 140 (10x14), 150 (10x15), 700 (5x140) gastro-resistant tablets.
Slovenian: Bolnišnično pakiranje s 50, 90, 100, 140, 140 (10x14), 150 (10x15), 700 (5x140) gastrorezistentnimi tabletami.
English: Treatment of duodenal ulcer
Slovenian: Zdravljenje z zdravilom Protium
English: Hospital packs with 50, 90, 100, 140, 140 (10x14), 150 (10x15), 700 (5x140) gastro-resistant tablets.
Slovenian: Bolnišnična pakiranja s 50, 90, 100, 140, 140 (10x14), 150 (10x15), 700 (5x140) gastrorezistentnimi tabletami.
English: Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).
Slovenian: Vsaka gastrorezistentna tableta vsebuje 40 mg pantoprazola v obliki natrijevega pantoprazolata seskvihidrata.
English: To treat symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastrooesophageal reflux disease
Slovenian: Za zdravljenje bolezenskih znakov (npr. zgaga, regurgitacija kisline, boleče požiranje), ki spremljajo gastro-ezofagealno refluksno bolezen Običajen odmerek je 1 tableta na dan.
English: Each vial contains 40 mg of pantoprazole (as sodium sequihydrate).
Slovenian: Vsaka viala vsebuje 40 mg pantoprazola v obliki natrijevega pantoprazolata seskvihidrata.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi dinatrijev edetat natrijev hidroksid (za uravnavanje pH) 6.2 Inkompatibilnosti To zdravilo se ne sme mešati z drugimi zdravili razen s tistimi, ki so navedeni v poglavju 6.6. 6.3 Rok uporabnosti Neodprta viala: 2 leti
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena gastrorezistentna tableta vsebuje 20 mg pantoprazola v obliki natrijevega pantoprazolata seskvihidrata.
English: HOW TO STORE PROTIUM
Slovenian: SHRANJEVANJE ZDRAVILA PROTIUM
English: Urticaria; Angioedema
Slovenian: Refluksni ezofagitis
English: A 4-week period is usually required for the treatment of gastric ulcers.
Slovenian: Za razjede želodca je navadno potrebno 4 tedensko zdravljenje.
English: Yellow, oval biconvex film coated tablet imprinted with “P20” in brown ink on one side.
Slovenian: Rumena, ovalna, bikonveksna filmsko obložena tableta z odtisom »P 20« v rjavi barvi na eni strani.
English: No dose adjustment is necessary in patients with impaired renal function.
Slovenian: Pri bolnikih z okvarjeno ledvično funkcijo odmerka ni treba prilagajati.
English: To prevent duodenal and stomach ulcers in patients who need to take NSAIDs continuously The usual dose is one tablet a day.
Slovenian: Za preprečevanje razjed dvanajstnika in želodca pri bolnikih, ki potrebujejo stalno zdravljenje z nesteroidnimi protivnetnimi zdravili
English: 10 gastro-resistant tablets 14 gastro-resistant tablets 15 gastro-resistant tablets
Slovenian: 14 gastrorezistentnimi tabletami 15 gastrorezistentnimi tabletami 28 gastrorezistentnimi tabletami.
English: 7 gastro-resistant tablets 10 gastro-resistant tablets 14 gastro-resistant tablets 15 gastro-resistant tablets 28 gastro-resistant tablets 30 gastro-resistant tablets
Slovenian: 14 gastrorezistentnimi tabletami 15 gastrorezistentnimi tabletami 24 gastrorezistentnimi tabletami 28 gastrorezistentnimi tabletami.
English: Yellow, oval, biconvex film-coated tablet imprinted with “P 40” in brown ink on one side.
Slovenian: Rumena, ovalna, bikonveksna filmsko obložena tableta z odtisom »P 40« v rjavi barvi na eni strani.
English: Eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pylori associated ulcers.
Slovenian: Odrasli - eradikacija Helicobacter pylory (H. pylori) v kombinaciji s primernim antibiotičnim zdravljenjem pri bolnikih s H. pylori povezanimi razjedami - razjeda želodca in dvanajstnika - sindrom Zollinger-Ellison in druga stanja s povečanim izločanjem želodčne kisline
English: Yellow, oval, biconvex gastro-resistant tablet imprinted with “P 40” on one side.
Slovenian: Rumena, ovalna, bikonveksna filmsko obložena tableta z odtisom »P 40« na eni strani.
English: 90 gastro-resistant tablets 100 gastro-resistant tablets 140 gastro-resistant tablets 140 (10x14) gastro-resistant tablets 150 (10x15) gastro-resistant tablets 700 (5x140) gastro-resistant tablets
Slovenian: 140 (10x14) gastrorezistentnimi tabletami 150 (10x15) gastrorezistentnimi tabletami 700 (5x140) gastrorezistentnimi tabletami
English: Yellow, oval, biconvex gastro-resistant tablet imprinted with “P 20” on one side.
Slovenian: Rumena, ovalna, bikonveksna filmsko obložena tableta z odtisom »P 20« na eni strani.
English: Renal Impairment No dose adjustment is necessary in patients with impaired renal function.
Slovenian: Okvara ledvic Pri bolnikih z okvarjeno ledvično funkcijo odmerka ni treba prilagajati.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena gastrorezistentna tableta vsebuje 40 mg pantoprazola v obliki natrijevega pantoprazolata seskvihidrata.
English: Stomach and duodenal ulcers.
Slovenian: - razjed želodca in dvanajstnika.
English: BEFORE YOU USE PROTIUM
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO PROTIUM
English: Adults: Preventing duodenal and stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who need to take NSAIDs continuously.
Slovenian: Preprečevanje razjed želodca in dvanajstnika, ki jih povzročajo neselektivna nesteroidna protivnetna zdravila pri bolnikih z visokim tveganjem, ki potrebujejo stalno zdravljenje z neselektivnimi nesteroidnimi protivnetnimi zdravili.
English: Long term treatment
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Packs with 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100, 112, 168 gastro-resistant tablets.
Slovenian: Pakiranje s 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100, 112, 168 gastrorezistentnimi tabletami.
English: NAME OF THE MEDICINAL PRODUCT Protium and associated names (see Annex I) 40 mg tablets [See Annex I - To be completed nationally]
Slovenian: Protium in z njim povezana imena (Glejte Dodatek I) 40 mg tablete [Glejte Dodatek I - Izpolni država članica]
English: Protium and associated names (see Annex I) 20 mg gastro-resistant tablets [See Annex I - To be completed nationally]
Slovenian: Protium in z njim povezana imena (Glejte Dodatek I) 20 mg gastrorezistentne tablete [Glejte Dodatek I - Izpolni država članica]
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Bottle label
Slovenian: PODATKI NA PRIMARNI OVOJNINI Nalepka plastenke
English: Protium and associated names (see Annex I) 40 mg gastro-resistant tablets [See Annex I - To be completed nationally]
Slovenian: Protium in z njim povezana imena (Glejte Dodatek I) 40 mg gastrorezistentne tablete [Glejte Dodatek I - Izpolni država članica]
English: Pack with 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100, 112, 168 gastro-resistant tablets.
Slovenian: pakiranja s 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100, 112, 168 gastrorezistentnimi tabletami.
English: PHARMACEUTICAL FORM Powder for solution for injection.
Slovenian: FARMACEVTSKA OBLIKA prašek za raztopino za injiciranje bel do umazano bel prašek
English: Abdominal distension and bloating; Constipation; Dry mouth;
Slovenian: Bolezni prebavil driska; slabost / bruhanje; napihovanje in napenjanje v trebuhu; zaprtost; suha usta; bolečine in neugodje v trebuhu
English: The usual dose is:
Slovenian: Zdravilo Protium se uporablja za:
English: 49 gastro-resistant tablets
Slovenian: 49 gastrorezistentnimi tabletami 56 gastrorezistentnimi tabletami.
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name}
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte Dodatek I - Izpolni država članica]
English: 50 gastro-resistant tablets
Slovenian: 50 gastrorezistentnimi tabletami 56 gastrorezistentnimi tabletami.
English: PHARMACEUTICAL FORM AND CONTENTS Pack with 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 100, 112, 168 gastro-resistant tablets.
Slovenian: Pakiranje s 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 100, 112, 168 gastrorezistentnimi tabletami.
English: Metabolism and nutrition disorders
Slovenian: Motnje reprodukcije in dojk ginekomastija
English: Sleep disorders
Slovenian: Pomožne snovi
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Protium and associated names (see Annex I) 20 mg tablets [See Annex I - To be completed nationally]
Slovenian: Protium in z njim povezana imena (Glejte Dodatek I) 20 mg tablete [Glejte Dodatek I - Izpolni država članica]
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 20 mg pantoprazola v obliki natrijevega pantoprazolata seskvihidrata.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena gastrorezistentna tableta vsebuje 40 mg pantoprazola v obliki natrijevega pantoprazolata seskvihidrata.
English: Body temperature increased; Oedema peripheral
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija, utrujenost in slabo počutje povišana telesna temperatura; periferni edem
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 40 mg pantoprazola v obliki natrijevega pantoprazolata seskvihidrata.
English: Excipients
Slovenian: Ciper
English: This means that it blocks the proteasome, which is a system within cells that breaks down proteins when they are no longer needed.
Slovenian: To pomeni, da zavira proteasom, tj. sistem v celicah, ki razgrajuje beljakovine, ko te niso več potrebne.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ninlaro on 21/11/2016.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ninlaro, veljavno po vsej Evropski uniji, izdala 21. novembra 2016.
English: This 4-week treatment cycle should be continued until the disease gets worse or side effects become unacceptable.
Slovenian: Ta štiritedenski cikel se mora nadaljevati, dokler se bolezen ne poslabša ali neželeni učinki postanejo nesprejemljivi.
English: What measures are being taken to ensure the safe and effective use of Ninlaro?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ninlaro?
English: This is a summary of the European public assessment report (EPAR) for Ninlaro.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ninlaro.
English: However, there is uncertainty regarding the size of the improvement because further analysis of the data showed a reduced effect.
Slovenian: Vendar pa v zvezi z obsegom izboljšanja obstaja negotovost, saj je nadaljnja analiza podatkov pokazala zmanjšan učinek zdravila.
English: Ninlaro ixazomib
Slovenian: Ninlaro iksazomib
English: Ninlaro is available as capsules (2.3, 3 and 4 mg) to be taken at least one hour before or two hours after food.
Slovenian: Zdravilo Ninlaro je na voljo v obliki kapsul (2,3 mg, 3 mg in 4 mg), ki se jemljejo vsaj eno uro pred zaužitjem hrane ali dve uri po tem.
English: The recommended dose is 4 mg taken once a week (on the same day of the week) for 3 consecutive weeks, followed by a week with no Ninlaro treatment.
Slovenian: Priporočeni odmerek je 4 mg enkrat na teden (isti dan v tednu) tri zaporedne tedne, čemur sledi teden brez zdravljenja z zdravilom Ninlaro.
English: When the proteins in the cancer cells are not broken down, including the proteins that control cell growth, the cancer cells are damaged and they eventually die.
Slovenian: Če se beljakovine v rakavih celicah, vključno z beljakovinami, ki nadzorujejo celično rast, ne razgrajujejo, se rakave celice poškodujejo in sčasoma odmrejo.
English: The European Medicines Agency therefore decided that Ninlaro's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Ninlaro večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: The most common side effects with Ninlaro taken together with lenalidomide and dexamethasone (seen in more than 1 in 5 people) were diarrhoea, constipation, thrombocytopenia (low blood platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell), peripheral neuropathy (nerve damage in the hands and feet causing tingling or numbness), nausea (feeling sick), peripheral oedema (swelling, especially of the ankles and feet), vomiting and nose and throat infection.
Slovenian: Najpogostejši neželeni učinki zdravila Ninlaro v kombinaciji z lenalidomidom in deksametazonom (opaženi pri več kot 1 bolniku od 5) so bili driska, zaprtost, trombocitopenija (nizke vrednosti trombocitov), nevtropenija (nizke vrednosti nevtrofilcev, vrste belih krvnih celic), periferna nevropatija (poškodba živcev v dlaneh in stopalih, ki povzroča ščemenje in odrevenelost), navzeja (siljenje na bruhanje), periferni edem (otekanje, zlasti gležnjev in stopal), bruhanje in okužbe nosu in žrela.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Ninlaro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Ninlaro je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: It is given together with two other medicines, lenalidomide and dexamethasone, to patients who have received at least one prior treatment.
Slovenian: Daje se v kombinaciji z dvema drugima zdraviloma, lenalidomidom in deksametazonom, bolnikom, ki so se predhodno zdravili z vsaj eno obliko zdravljenja.
English: Other information about Ninlaro
Slovenian: Druge informacije o zdravilu Ninlaro
English: The company that markets Ninlaro will provide the final data from the main study on the effects of the medicine on overall survival.
Slovenian: Družba, ki trži zdravilo Ninlaro, bo predložila končne podatke iz glavne študije o učinkih zdravila na celokupno preživetje.
English: The dose may be reduced also in patients with moderately or severely reduced liver function and patients with severely reduced kidney function.
Slovenian: Odmerek se lahko zmanjša tudi pri bolnikih z zmerno ali resno okvaro delovanja jeter in bolnikih z resno okvaro delovanja ledvic.
English: What is Ninlaro and what is it used for?
Slovenian: Kaj je zdravilo Ninlaro in za kaj se uporablja?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ninlaro have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ninlaro upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: A first analysis of the data indicated that Ninlaro is effective at prolonging the time patients live without their disease getting worse (progression-free survival): patients treated with Ninlaro lived for an average of 21 months without their disease getting worse compared with 15 months in patients given placebo.
Slovenian: Prva analiza podatkov je pokazala, da je zdravilo Ninlaro učinkovito pri podaljšanju časa, ko so bolniki živeli brez poslabšanja bolezni (preživetje brez napredovanja): bolniki, ki so se zdravili z zdravilom Ninlaro, so živeli povprečno 21 mesecev brez poslabšanja bolezni v primerjavi s 15 meseci pri bolnikih, ki so prejemali placebo.
English: Similar side effects were seen when lenalidomide and dexamethasone were used without Ninlaro.
Slovenian: Podobne neželene učinke so opazili, kadar so lenalidomid in deksametazon uporabljali brez zdravila Ninlaro.
English: For more information about treatment with Ninlaro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ninlaro preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: In a subsequent similar study involving 115 patients, many with advanced disease, those receiving Ninlaro with lenalidomide and dexamethasone lived on average for 6.7 months without their disease getting worse compared with 4 months in those receiving placebo with lenalidomide and dexamethasone.
Slovenian: V nadaljnji podobni študiji, v katero je bilo vključenih 115 bolnikov z večinoma napredovalo boleznijo, so tisti, ki so prejemali zdravilo Ninlaro skupaj z lenalidomidom in deksametazonom živeli v povprečju 6,7 meseca brez poslabšanja bolezni v primerjavi s 4 meseci pri tistih, ki so prejemali placebo skupaj z lenalidomidom in deksametazonom.
English: Ninlaro has been investigated in one main study involving 722 adults with multiple myeloma whose disease had not got better or had come back after previous treatment.
Slovenian: Zdravilo Ninlaro so preiskovali v eni glavni študiji, ki je vključevala 722 odraslih z diseminiranim plazmacitomom, katerih bolezen se ni izboljšala ali se je ponovila.
English: The full EPAR for Ninlaro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ninlaro je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What are the risks associated with Ninlaro?
Slovenian: Kakšna tveganja so povezana z zdravilom Ninlaro?
English: It is not intended to provide practical advice on how to use Ninlaro.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: What benefits of Ninlaro have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Ninlaro izkazalo v študijah?
English: Because the number of patients with multiple myeloma is low, the disease is considered ‘rare', and Ninlaro was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 September
Slovenian: Ker je bolnikov z diseminiranim plazmacitomom malo, velja ta bolezen za redko, zato je bilo zdravilo Ninlaro 27. septembra 2011 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Ninlaro has been given ‘conditional approval'.
Slovenian: Zdravilo Ninlaro je pridobilo „pogojno dovoljenje za promet“.
English: For practical information about using Ninlaro, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Ninlaro naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.