FrancophonIA/ELRC3.0 huggingface dataset:
English: Pregabalin Zentiva 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg hard capsules are packed into PVC/alu blisters as primary packaging.
Slovenian: Pregabalin Zentiva 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg in 300 mg trde kapsule so pakirane v PVC/alu pretisnih omotih kot primarni ovojnini.
English: Pregabalin Zentiva 25 mg and 50 mg is available in pack of 14, 21, 56, 84, 98 and 100 hard capsules.
Slovenian: Pregabalin Zentiva 25 mg in 50 mg so na voljo v pakiranju po 14, 21, 56, 84, 98 ali 100 trdih kapsul.
English: Pregabalin Zentiva 225 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Zentiva 225 mg
English: It is advised not to drink alcohol while taking Pregabalin Zentiva.
Slovenian: Če jemljete zdravilo Pregabalin Zentiva, odsvetujemo pitje alkohola.
English: How to store Pregabalin Zentiva
Slovenian: Shranjevanje zdravila Pregabalin Zentiva
English: Pregabalin Zentiva 150 mg hard capsules: EU/1/15/1021/017
Slovenian: Pregabalin Zentiva 150 mg trde kapsule: EU/1/15/1021/017
English: What Pregabalin Zentiva contains
Slovenian: Kaj vsebuje zdravilo Pregabalin Zentiva
English: Pregabalin Zentiva 50 mg hard capsules: EU/1/15/1021/006
Slovenian: Pregabalin Zentiva 50 mg trde kapsule: EU/1/15/1021/006
English: Pregabalin Zentiva 225 mg hard capsules: EU/1/15/1021/023
Slovenian: Pregabalin Zentiva 225 mg trde kapsule: EU/1/15/1021/023
English: Pregabalin Zentiva 150 mg hard capsules
Slovenian: Pregabalin Zentiva 150 mg trde kapsule
English: Pregabalin Zentiva 75 mg hard capsules: EU/1/15/1021/011
Slovenian: Pregabalin Zentiva 75 mg trde kapsule: EU/1/15/1021/011
English: Pregabalin Zentiva 300 mg hard capsules: EU/1/15/1021/026
Slovenian: Pregabalin Zentiva 300 mg trde kapsule: EU/1/15/1021/026
English: Pregabalin Zentiva 200 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Zentiva 200 mg
English: Pregabalin Zentiva 225 mg hard capsules
Slovenian: Pregabalin Zentiva 225 mg trde kapsule
English: Pregabalin Zentiva 300 mg hard capsules
Slovenian: Pregabalin Zentiva 300 mg trde kapsule
English: Pregabalin Zentiva 300 mg hard capsules Capsule cap
Slovenian: Pregabalin Zentiva 300 mg trde kapsule Pokrovček kapsule
English: Pregabalin Zentiva 50 mg hard capsules
Slovenian: Pregabalin Zentiva 50 mg trde kapsule
English: Pregabalin Zentiva 225 mg hard capsules Pregabalin
Slovenian: Pregabalin Zentiva 225 mg trde kapsule pregabalin
English: Pregabalin Zentiva 225 mg hard capsules Capsule cap
Slovenian: Pregabalin Zentiva 225 mg trde kapsule Pokrovček kapsule
English: Pregabalin Zentiva 75 mg hard capsules Pregabalin
Slovenian: Pregabalin Zentiva 75 mg trde kapsule pregabalin
English: Pregabalin Zentiva 75 mg hard capsules Capsule cap
Slovenian: Pregabalin Zentiva 75 mg trde kapsule Pokrovček kapsule
English: Zentiva logo
Slovenian: ŠTEVILKA SERIJE Lot
English: Pregabalin Zentiva 100 mg hard capsules: EU/1/15/1021/014
Slovenian: Pregabalin Zentiva 100 mg trde kapsule: EU/1/15/1021/014
English: Pregabalin Zentiva 25 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Zentiva 25 mg
English: Pregabalin Zentiva 200 mg hard capsules: EU/1/15/1021/020
Slovenian: Pregabalin Zentiva 200 mg trde kapsule: EU/1/15/1021/020
English: Pregabalin Zentiva 75 mg hard capsules
Slovenian: Pregabalin Zentiva 75 mg trde kapsule
English: Pregabalin Zentiva 25 mg hard capsules: EU/1/15/1021/001
Slovenian: Pregabalin Zentiva 25 mg trde kapsule: EU/1/15/1021/001
English: Pregabalin Zentiva 200 mg hard capsules
Slovenian: Pregabalin Zentiva 200 mg trde kapsule
English: Pregabalin Zentiva 100 mg hard capsules Pregabalin
Slovenian: Pregabalin Zentiva 100 mg trde kapsule pregabalin
English: Pregabalin Zentiva 150 mg hard capsules Pregabalin
Slovenian: Pregabalin Zentiva 150 mg trde kapsule pregabalin
English: Pregabalin Zentiva 75 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Zentiva 75 mg
English: Pregabalin Zentiva 25 mg hard capsules Pregabalin
Slovenian: Pregabalin Zentiva 25 mg trde kapsule pregabalin
English: Pregabalin Zentiva 300 mg hard capsules Pregabalin
Slovenian: Pregabalin Zentiva 300 mg trde kapsule pregabalin
English: Pregabalin Zentiva 100 mg hard capsules
Slovenian: Pregabalin Zentiva 100 mg trde kapsule
English: Pregabalin Zentiva 100 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Zentiva 100 mg
English: Pregabalin Zentiva 50 mg hard capsules Pregabalin
Slovenian: Pregabalin Zentiva 50 mg trde kapsule pregabalin
English: Pregabalin Zentiva 25 mg hard capsules
Slovenian: Pregabalin Zentiva 25 mg trde kapsule
English: Pregabalin Zentiva 200 mg hard capsules Each hard capsule contains 200 mg of pregabalin.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 200 mg pregabalina.
English: Pregabalin Zentiva 200 mg hard capsules Pregabalin
Slovenian: Pregabalin Zentiva 200 mg trde kapsule pregabalin
English: Pregabalin Zentiva 100 mg hard capsules Each hard capsule contains 100 mg of pregabalin.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 100 mg pregabalina.
English: Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin
Slovenian: − rdeči železov oksid (E172)
English: Pregabalin Zentiva 150 mg hard capsules Each hard capsule contains 150 mg of pregabalin.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 150 mg pregabalina.
English: Pregabalin Zentiva 300 mg hard capsules Each hard capsule contains 300 mg of pregabalin.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 300 mg pregabalina.
English: Pregabalin Zentiva 75 mg hard capsules Each hard capsule contains 75 mg of pregabalin.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 75 mg pregabalina.
English: Pregabalin Zentiva 300 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Zentiva 300 mg
English: Pregabalin Zentiva 50 mg hard capsules Each hard capsule contains 50 mg of pregabalin.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 50 mg pregabalina.
English: Pregabalin Zentiva 150 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Zentiva 150 mg
English: BID or TID BID or TID Once daily or BID Once daily
Slovenian: 2- ali 3-krat/dan 2- ali 3-krat/dan 1-krat/dan ali 2krat/dan 1-krat/dan dodaten odmerek po hemodializi (mg)
English: Pregabalin Zentiva 25 mg hard capsules Capsule cap and body
Slovenian: Pregabalin Zentiva 50 mg trde kapsule Pokrovček in telo kapsule
English: Pregabalin Zentiva 225 mg hard capsules Each hard capsule contains 225 mg of pregabalin.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 225 mg pregabalina.
English: Pregabalin Zentiva 50 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Zentiva 50 mg
English: The physician information should contain the following key messages:
Slovenian: Podatki za zdravnika morajo vsebovati naslednje ključne vsebine:
English: • The possibility to include patients in the registry study to facilitate the collection of long term efficacy and safety data;
Slovenian: • o možnosti vključevanja bolnikov v študijski register, s katerim bi omogočili zbiranje dolgoročnih podatkov o učinkovitosti in varnosti zdravila;
English: • The proper patient management as regards the interaction with vaccination;
Slovenian: • o ustreznem vodenju bolnikov glede interakcij s cepivi;
English: • The risk of serious infections, including opportunistic bacterial, viral and fungal infections in patients treated with Ilaris;
Slovenian: • o tveganju za resne okužbe, vključno z oportunističnimi bakterijskimi, virusnimi in glivičnimi okužbami, pri bolnikih, ki prejemajo zdravilo Ilaris;
English: • The identified or potential risk of immunogenicity that might lead to immune-mediated symptoms;
Slovenian: • o ugotovljenih ali možnih tveganjih za imunogenost, ki bi lahko povzročila imunsko povzročene simptome;
English: • The need to instruct patients on proper techniques for self-administration when the patient is willing and capable to do so, and guidance for Health Care Professionals on how to report administration errors;
Slovenian: • o potrebi za poučevanje bolnikov glede ustreznih tehnik samoinjiciranja v primeru, da je bolnik pripravljen in sposoben samoinjiciranja, ter navodila za zdravstvene delavce glede poročanja napak pri apliciranju zdravila;
English: • The need for Health Care Professionals to perform an annual clinical assessment of patients regarding a potential increased risk for the development of malignancies;
Slovenian: • o potrebi za vsakoletno klinično presojo bolnikov, ki jo morajo izvajati zdravstveni delavci glede možnega povečanja tveganja za razvoj malignih bolezni;
English: • The role and use of patient alert card.
Slovenian: • o namenu in uporabi opozorilne kartice za bolnika.
English: • The need to measure neutrophil counts prior to initiating treatment, after 1 to 2 months and periodically thereafter while receiving Ilaris as treatment with Ilaris should not be initiated in patients with neutropenia;
Slovenian: • o potrebi za določanje števila nevtrofilcev pred začetkom zdravljenja, 1 do 2 meseca po začetku zdravljenja in nato v rednih presledkih med zdravljenjem z zdravilom Ilaris, saj se pri bolnikih z nevtropenijo ne sme uvesti zdravljenja z zdravilom Ilaris;
English: • The need to monitor patients for changes in their lipid profiles;
Slovenian: • o potrebi za spremljanje bolnikov glede sprememb vrednosti lipidov v krvi;
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Država članica mora zagotoviti vzpostavitev vseh pogojev ali omejitev v zvezi z varno in učinkovito uporabo zdravila, kot je opisano spodaj.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO VZPOSTAVITI DRŽAVE ČLANICE
English: • Physician information
Slovenian: • podatke za zdravnika,
English: • The risk of acute injection-related reactions;
Slovenian: • o tveganju za akutne reakcije, do katerih lahko pride zaradi injiciranja;
English: • The unknown safety of Ilaris in pregnant and lactating women, thus the need for physicians to discuss this risk with patients if they become or plan to become pregnant;
Slovenian: • o dejstvu, da varnost uporabe zdravila Ilaris med nosečnostjo in dojenjem ni opredeljena in mora zato zdravnik bolnicam razložiti tveganje v primeru, da zanosijo ali načrtujejo nosečnost;
English: Therefore, it should not be used in these indications outside the context of a clinical trial.
Slovenian: Zato se ga ne sme uporabljati za takšne indikacije izven okvira kliničnih preskušanj.
English: • Obligations of the health care professional in relation to the prescribing of romiplostim and the need to provide comprehensive advice on risk-benefit to patients.
Slovenian: • Obveznosti zdravnikov v zvezi s predpisovanjem romiplostima in potreba po zagotavljanju izčrpnega svetovanja bolnikom o koristi in tveganju.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE ZDRAVILA, KI MORAJO BITI ZAGOTOVLJENI S STRANI DRŽAVE ČLANICE
English: Antibody testing available upon request of physician, contact details for this antibody testing.
Slovenian: Testiranje protiteles, ki je na razpolago na zdravnikovo zahtevo, in kontaktne podrobnosti za to testiranje protiteles.
English: The Member States must ensure that all conditions with regard to the safe and effective use of the medicinal products described below are implemented:
Slovenian: Država članica mora zagotoviti vse spodaj navedene pogoje v zvezi z varno in učinkovito uporabo zdravil:
English: • The documents will discuss the following identified and potential risks: The incidence in clinical trials and likelihood of reoccurrence of thrombocytopenia after cessation of treatment.
Slovenian: • Ti dokumenti bodo obravnavali naslednja ugotovljena in možna tveganja: Incidenco v kliničnih preskušanjih in verjetnost za ponovitev trombocitopenije po prenehanju zdravljenja.
English: Provision of dosing calculator to simplify the calculation of the correct dose and guide in correct reconstitution and administration.
Slovenian: Priskrbljeno bo računalo odmerka za enostavnejše izračunavanje pravilnega odmerka ter navodilo za pravilno pripravo in apliciranje.
English: Advice on when further investigations and a bone marrow biopsy might be appropriate.
Slovenian: Nasvet, kdaj so primerne nadaljnje preiskave in biopsija kostnega mozga.
English: Data from clinical trials in MDS on the incidence of blast cell increases and progression to AML.
Slovenian: Podatki iz kliničnih preskušanj pri MDS o incidenci porasta blastnih celic in napredovanju v AML.
English: Romiplostim should not be used in patients with moderate to severe hepatic impairment unless the expected benefit outweighs the identified risk of portal venous thrombosis.
Slovenian: Romiplostima se ne sme uporabljati pri bolnikih z zmerno ali hudo okvaro jeter, razen če pričakovana korist odtehta ugotovljeno tveganje za portalno vensko trombozo.
English: Advice on management of patients upon cessation of romiplostim.
Slovenian: Nasvet o medicinski oskrbi bolnikov po prenehanju uporabe romiplostima.
English: Advice to follow dose adjustment guidelines to avoid platelet counts above the normal range.
Slovenian: Nasvet o upoštevanju smernic za prilagoditev odmerka, da bi se izognili številu trombocitov, večjemu od normalnega.
English: If use of romiplostim is deemed necessary, platelet count should be closely monitored to minimise the risk of thromboembolic complications.
Slovenian: Če je uporaba romiplostima potrebna, je treba število trombocitov natančno kontrolirati, da bi zmanjšali tveganje za trombembolične zaplete.
English: The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following:
Slovenian: Takšen program mora izvesti na nacionalni ravni, da bodo pred predpisovanjem zdravila vsi zdravniki dobili informacijski komplet za zdravstveno osebje, ki vsebuje:
English: • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Slovenian: • Povzetek glavnih značilnosti zdravila (SmPC) in navodilo za uporabo
English: The potential for thromboembolic events in patients with chronic ITP and those known risk factors for thromboembolic events (e.g., Factor V Leiden, ATIII deficiency, antiphospholipid syndrome).
Slovenian: Možnost trombemboličnih dogodkov pri bolnikih s kronično ITP and pri tistih z znanimi dejavniki tveganja za trombembolične dogodke (npr. faktorjem V Leiden, pomanjkanjem ATIII, antifosfolipidnim sindromom).
English: Background rates of reticulin in the bone marrow in ITP patients and the observed incidence and potential mechanism of action of reticulin deposition in response to romiplostim.
Slovenian: Osnovne deleže retikulina v kostnem mozgu pri bolnikih z ITP ter ugotovljeno incidenco in možne mehanizme odlaganja retikulina kot odziv na romiplostim.
English: Background information on reticulin in the bone marrow.
Slovenian: Osnovne informacije o retikulinu v kostnem mozgu.
English: Romiplostim may induce the progression of existing haematological malignancies and myelodysplastic syndrome (MDS).
Slovenian: Romiplostim lahko izzove napredovanje obstoječih hematoloških malignomov in mielodisplastičnega sindroma.
English: Clarification that risk-benefit for the treatment of paediatric ITP has not been established.
Slovenian: Pojasnilo, da koristi in tveganja zdravljenja pediatrične ITP niso ugotovljeni.
English: The incidence of medication errors in clinical trials.
Slovenian: Incidenco napak z zdravilom v kliničnih preskušanjih.
English: Warning that, whilst no data exists, an outcome of reticulin deposition in response to romiplostim may be bone marrow fibrosis.
Slovenian: Opozorilo, da je možna (ker ni na voljo podatkov) posledica odlaganja retikulina kot odziv na romiplostim fibroza kostnega mozga.
English: The implications of romiplostim-neutralising antibodies cross-reacting with endogenous thrombopoietin (TPO).
Slovenian: Posledice navzkrižnega reagiranja protiteles, ki nevtralizirajo romiplostim, z endogenim trombopoetinom (TPO).
English: The incidence of neutralising antibodies to romiplostim in clinical trials.
Slovenian: Incidenco pojava nevtralizirajočih protiteles proti romiplostimu v kliničnih preskušanjih.
English: Reiteration that the risk-benefit for the treatment of thrombocytopenia in non ITP patient populations has not been established.
Slovenian: Ponoven poudarek, da koristi in tveganja zdravljenja trombocitopenije niso ugotovljene pri bolnikih brez ITP.
English: • Posology
Slovenian: • Odmerjanje
English: The incidence in clinical trials of thrombotic/thromboembolic complications.
Slovenian: Incidenco trombotičnih/trombemboličnih zapletov v kliničnih preskušanjih.
English: United Kingdom Alkem Pharma GmbH
Slovenian: Velika Britanija Alkem Pharma GmbH
English: Invented name
Slovenian: Predlagatelj Izmišljeno ime Zdravilna učinkovina
English: Ricefan 500 mg Cefuroxime 500 mg Film-coated tablet
Slovenian: Ricefan 500 mg Cefuroksim 500 mg Filmsko obložena tableta
English: Cefuroxime 500mg film-coated tablets
Slovenian: Cefuroxime 500mg filmcoated tablets
English: Ricefan 250 mg Cefuroxime 250 mg Film-coated tablet
Slovenian: Ricefan 250 mg Cefuroksim 250 mg Filmsko obložena tableta
English: Cefuroxime 250 mg Tablet
Slovenian: Cefuroksim 250 mg Tableta
English: Cefuroxime 500 mg Tablet
Slovenian: Cefuroksim 500 mg Tableta
English: Cefuroxime 250mg film-coated tablets
Slovenian: Cefuroxime 250mg filmcoated tablets
English: 14 October 2016 EMA/659373/2016 EMEA/H/C/004306
Slovenian: 14. oktober 2016 EMA/659373/2016 EMEA/H/C/004306
English: active form happens more readily in cancer cells than in normal cells.
Slovenian: Pretvorba v aktivno obliko lažje poteka v rakavih celicah kot v normalnih celicah.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing its application because of a change in commercial strategy.
Slovenian: Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da se je za umik vloge odločila zaradi spremembe poslovne strategije.
English: The company had not yet responded to the questions at the time of the withdrawal.
Slovenian: Družba ob umiku še ni odgovorila na zastavljena vprašanja.
English: Based on the review of the data at the time of the withdrawal, the CHMP had asked the company to provide clarification on some aspects of manufacturing, storage and plans to monitor safety and effectiveness of the medicine after authorisation.
Slovenian: Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge od družbe zahteval, naj pojasni določene vidike proizvodnje, shranjevanja in načrtov za spremljanje varnosti in učinkovitosti zdravila po izdaji dovoljenja za promet.
English: This prevents the cancer cells from growing and dividing, while normal cells are only slightly affected.
Slovenian: To rakavim celicam prepreči rast in delitev, na normalne celice pa ima le malo vpliva.
English: This means that it was intended to be similar to a ‘reference medicine' already authorised in the European Union called Alimta.
Slovenian: To pomeni, da naj bi bilo podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Alimta.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for this product.
Slovenian: Družba je odbor CHMP obvestila, da trenutno ne potekajo klinična preskušanja ali programi sočutne uporabe tega zdravila.
English: The active substance in both medicines, pemetrexed, is changed in the body into an active form that blocks enzymes needed to make genetic material (DNA and RNA).
Slovenian: Zdravilna učinkovina v obeh zdravilih, pemetreksed, se v telesu spremeni v aktivno obliko, ki zavira encime, potrebne za izdelovanje genetskega materiala (DNK in RNK).
English: On 22 September 2016, Hospira UK Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pemetrexed (as ditromethamine) Hospira, for the treatment of malignant pleural mesothelioma and non-small-cell lung cancer.
Slovenian: Družba Hospira UK Limited je 22. septembra 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Pemetreksed (v obliki ditrometamina) Hospira, namenjenim zdravljenju malignega plevralnega mezotelioma in nedrobnoceličnega pljučnega raka.
English: Pemetrexed (as ditromethamine) Hospira was expected to be used to treat two types of lung cancer: malignant pleural mesothelioma (a cancer of the lining of the lungs usually caused by exposure to asbestos) and advanced non-small-cell lung cancer of the kind known as ‘non-squamous'.
Slovenian: Zdravilo Pemetreksed (v obliki ditrometamina) Hospira naj bi se uporabljalo za zdravljenje dveh vrst pljučnega raka: malignega plevralnega mezotelioma (raka pljučne sluznice, ki ga običajno povzroči izpostavljenost azbestu) in napredovalega nedrobnoceličnega pljučnega raka, znanega kot „neskvamozni“ tip.
English: Because Pemetrexed (as ditromethamine) Hospira was developed as a generic medicine, the company presented the results of studies to show the quality of the medicine.
Slovenian: Ker je bilo zdravilo Pemetreksed (v obliki ditrometamina) Hospira razvito kot generično zdravilo, je družba predstavila rezultate študij, ki dokazujejo kakovost zdravila.
English: The CHMP thought that the company could have addressed these questions and was of the provisional opinion that Pemetrexed (as ditromethamine) Hospira could have been approved for the treatment of malignant pleural mesothelioma and nonsmall-cell lung cancer.
Slovenian: Menil je, da bi se lahko družba odzvala na ta vprašanja, in je zato začasno menil, da se lahko zdravilo Pemetreksed (v obliki ditrometamina) Hospira odobri za zdravljenje malignega plevralnega mezotelioma in nedrobnoceličnega pljučnega raka.
English: Pemetrexed (as ditromethamine) Hospira is a cancer medicine that contains the active substance pemetrexed.
Slovenian: Pemetreksed (v obliki ditrometamina) Hospira je zdravilo za zdravljenje raka, ki vsebuje zdravilno učinkovino pemetreksed.
English: Pemetrexed (as ditromethamine) Hospira was developed as a ‘generic medicine'.
Slovenian: Zdravilo Pemetreksed (v obliki ditrometamina) Hospira je bilo razvito kot „generično zdravilo“.
English: Pemetrexed (as ditromethamine) Hospira is expected to work in the same way as the reference medicine, Alimta.
Slovenian: Zdravilo Pemetreksed (v obliki ditrometamina) Hospira naj bi delovalo enako kot referenčno zdravilo Alimta.
English: No further studies were carried out because Pemetrexed (as ditromethamine) Hospira is a generic medicine that is given by infusion into a vein and contains the same active substance as the reference medicine, Alimta.
Slovenian: Ker je zdravilo Pemetreksed (v obliki ditrometamina) Hospira generično zdravilo, ki se daje z infundiranjem v veno in vsebuje enako zdravilno učinkovino kot referenčno zdravilo Alimta, niso bile opravljene nobene dodatne študije.
English: What is Pemetrexed (as ditromethamine) Hospira?
Slovenian: Kaj je zdravilo Pemetreksed (v obliki ditrometamina) Hospira?
English: How does Pemetrexed (as ditromethamine) Hospira work?
Slovenian: Kako zdravilo Pemetreksed (v obliki ditrometamina) Hospira deluje?
English: What was Pemetrexed (as ditromethamine) Hospira expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Pemetreksed (v obliki ditrometamina) Hospira uporabljalo?
English: Patients should not use more than one capsule in a day.
Slovenian: Bolniki ne smejo vzeti več kot eno kapsulo na dan.
English: The recommended dose is one capsule once a day at the same time each day.
Slovenian: Priporočeni odmerek je ena kapsula na dan vedno ob istem času.