FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Blincyto, blinatumomab, is an antibody that has been designed to attach to a protein (CD19) found on B cells, including ALL cells.
Slovenian: Učinkovina v zdravilu Blincyto, blinatumomab, je protitelo, ki je bilo zasnovano tako, da se veže na beljakovino (CD19) na celicah B, vključno s celicami ALL.
English: Patients may be treated for up to 3 additional treatment cycles, each one given after a 2-week treatment-free interval.
Slovenian: Bolniki se lahko zdravijo z največ tremi dodatnimi ciklusi, vsakega od katerih prejmejo po dvotedenskem premoru brez zdravljenja.
English: Each cycle of treatment is separated by a 2-week treatment-free interval.
Slovenian: Vsakemu ciklusu zdravljenja sledi dvotedenski premor brez zdravljenja.
English: Blincyto therefore acts as a ‘bridge' bringing T cells and B cells together and causing the T cells to release substances that eventually kill the cancerous B cells.
Slovenian: Zdravilo Blincyto torej deluje kot most, ki povezuje celice T in celice B ter povzroči, da celice T sproščajo snovi, ki sčasoma uničijo rakave celice B.
English: A study in 70 children aged 1 year and above with Philadelphia-chromosome-negative B-precursor ALL found that in 33% of patients treatment with Blincyto led to a resolution of the disease.
Slovenian: V študiji pri 70 otrocih, starih eno leto in več, z akutno limfoblastno levkemijo predhodniških celic B z negativnim kromosomom Philadelphia so ugotovili, da je pri 33 % bolnikov zdravljenje z zdravilom Blincyto privedlo do odprave bolezni.
English: Patients were given Blincyto for up to 5 treatment cycles.
Slovenian: Bolniki so prejeli do pet ciklusov zdravljenja z zdravilom Blincyto.
English: Blincyto is also used in adults who have been treated for B-precursor ALL and have minimal residual disease (which means that they still have some detectable cancer cells in their body).
Slovenian: Zdravilo Blincyto se uporablja tudi pri odraslih, ki so se zdravili zaradi akutne limfoblastne levkemije predhodniških celic B in imajo minimalno rezidualno bolezen (kar pomeni, da imajo v svojem telesu še vedno nekaj zaznanih rakavih celic).
English: Blincyto must not be given to breastfeeding women.
Slovenian: Zdravilo Blincyto se ne sme dajati doječim materam.
English: The Agency noted that Blincyto is beneficial for high-risk adults and children with Philadelphia-chromosome-negative B-precursor ALL who have few therapeutic options and who generally have a poor prognosis.
Slovenian: Menila je, da je zdravilo Blincyto koristno za odrasle bolnike in otroke z akutno limfoblastno levkemijo predhodniških celic B z negativnim kromosomom Philadelphia, pri katerih obstaja veliko tveganje in ki imajo omejene terapevtske možnosti ter na splošno slabo prognozo.
English: Blincyto is a medicine used to treat a blood cancer called B-precursor acute lymphoblastic leukaemia (ALL) in patients above 1 year of age when the cancer has come back (relapsed) or has not improved with previous treatment (refractory).
Slovenian: Zdravilo Blincyto se uporablja za zdravljenje krvnega raka, imenovanega akutna limfoblastna levkemija (ALL) predhodniških celic B, pri bolnikih, starejših od enega leta, pri katerih se je rak ponovil (recidiviral) ali se po predhodnem zdravljenju ni izboljšal (neodziven).
English: For treatment of relapsed or refractory B-precursor ALL, the dose depends on the patient's bodyweight.
Slovenian: Pri zdravljenju ponovljene ali neodzivne akutne limfoblastne levkemije predhodniških celic B je odmerek odvisen od bolnikove telesne mase.
English: How is Blincyto used?
Slovenian: Kako se zdravilo Blincyto uporablja?
English: Blincyto is also effective at removing residual cancer cells in adults who have been treated for B-precursor ALL and who are at high risk of the cancer coming back.
Slovenian: Zdravilo Blincyto tudi učinkovito odstranjuje rezidualne rakave celice pri odraslih, ki so se zdravili zaradi akutne limfoblastne levkemije predhodniških celic B in ki so zelo ogroženi za ponovitev raka.
English: How does Blincyto work?
Slovenian: Kako zdravilo Blincyto deluje?
English: Blincyto contains the active substance blinatumomab and is used on its own.
Slovenian: Zdravilo Blincyto vsebuje učinkovino blinatumomab in se uporablja kot samostojno zdravilo.
English: For the full list of side effects of Blincyto, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Blincyto, glejte navodilo za uporabo.
English: Blincyto is given by infusion (drip) into a vein using a pump device.
Slovenian: Zdravilo Blincyto se daje z infundiranjem (kapalno infuzijo) v veno s črpalko.
English: Blincyto has been studied in one main study in 189 Philadelphia-chromosome-negative adults with Bprecursor ALL whose leukaemia had come back or had not improved with treatment.
Slovenian: Zdravilo Blincyto so proučevali v eni glavni študiji, v katero je bilo vključenih 189 odraslih z akutno limfoblastno levkemijo predhodniških celic B z negativnim kromosomom Philadelphia, pri katerih se je levkemija ponovila ali katerih stanje se z zdravljenjem ni izboljšalo.
English: Iceland Lyfis ehf.
Slovenian: Islandija Lyfis ehf.
English: Sweden Medical Valley Invest AB
Slovenian: Švedska Medical Valley Invest AB
English: Annex IA: Medicinal products recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established
Slovenian: Priloga IA: Zdravila, priporočena za ohranitev, in vloge za pridobitev dovoljenja za promet z zdravilom, za katera je bila ugotovljena bioekvivalenca z referenčnim zdravilom v EU
English: Annex I List of nationally authorised medicinal products and marketing authorisation applications
Slovenian: Priloga I Seznam nacionalno odobrenih zdravil in vlog za pridobitev dovoljenja za promet z zdravilom
English: Teva Nederland B.V.
Slovenian: Nizozemska Teva Nederland B.V.
English: Annex IB: Products for which the marketing authorisations are recommended for suspension and marketing authorisation applications which do not satisfy the criteria for authorisation
Slovenian: Priloga IB: Zdravila, za katere se priporoča začasni umik dovoljenja za promet z zdravilom, in vloge za pridobitev dovoljenja za promet z zdravilom, ki ne ustrezajo merilom za pridobitev dovoljenja
English: Germany Hexal Aktiengesellschaft
Slovenian: Hexal Aktiengesellschaft
English: amoxicillin mg
Slovenian: amoksicilin mg
English: Medipha Sante AMOXICILLINE MEDIPHA 1 g amoxicillin
Slovenian: Medipha Sante AMOXICILLINE MEDIPHA 1 g amoksicilin
English: Rasagiline Brown & Burk 1mg Tablets rasagiline
Slovenian: Rasagiline Brown & Burk 1mg Tablets razagilin
English: Malacomp HEXAL junior atovaquone/ proguanil
Slovenian: Malacomp HEXAL junior atovakon/ progvanil
English: Rasagilin Micro Labs 1 mg Tabletten rasagiline
Slovenian: Rasagilin Micro Labs 1 mg Tabletten razagilin
English: Germany Hormosan Pharma
Slovenian: Hormosan Pharma
English: Amoxicilina Brown amoxicillin
Slovenian: Amoxicilina Brown amoksicilin
English: Saquinavir Accord 500 mg plėvele dengtos tabletės saquinavir
Slovenian: Saquinavir Accord 500 mg plėvele dengtos tabletės sakvinavir
English: Celecoxib Medical Valley celecoxib
Slovenian: Celecoxib Medical Valley celekoksib
English: Amoxicilline Authou amoxicillin
Slovenian: Amoxicilline Authou amoksicilin
English: Sweden Orifarm Generics A/S
Slovenian: Švedska Orifarm Generics A/S
English: Saquinavir Accord saquinavir
Slovenian: Saquinavir Accord sakvinavir
English: Celecoxib Hetero celecoxib
Slovenian: Celecoxib Hetero celekoksib
English: Celecoxib Brill Pharma 100 mg and 200 mg cápsulas duras celecoxib
Slovenian: Celecoxib Brill Pharma 100 mg and 200 mg cápsulas duras celekoksib
English: Saquinavir Farmoz saquinavir
Slovenian: Saquinavir Farmoz sakvinavir
English: Finland Sandoz A/S
Slovenian: Sandoz A/S
English: Sweden Sandoz A/S
Slovenian: Švedska Sandoz A/S
English: Saquinavir Accord 500 mg film-coated tablets saquinavir
Slovenian: Saquinavir Accord 500 mg film-coated tablets sakvinavir
English: Sweden Mylan AB
Slovenian: Švedska Mylan AB
English: Saquinavir saquinavir
Slovenian: Saquinavir sakvinavir
English: FarmozSociedade Técnico Medicinal, S.A.
Slovenian: Técnico Medicinal, S.A.
English: Amoxicillin Micro Labs 1000 mg amoxicillin
Slovenian: Amoxicillin Micro Labs 1000 mg amoksicilin
English: Celecoxib
Slovenian: celekoksib
English: Denmark ratiopharm GmBH
Slovenian: Danska ratiopharm GmBH
English: Finland ratiopharm GmbH
Slovenian: Finska ratiopharm GmbH
English: Amoxicillin Micro Labs 750 mg amoxicillin
Slovenian: Amoxicillin Micro Labs 750 mg amoksicilin
English: Abacavir / Lamivudine abacavir/ lamivudine
Slovenian: Abacavir / Lamivudine abakavir/ lamivudin
English: Germany Glenmark Arzneimittel
Slovenian: Glenmark Arzneimittel GmbH
English: Amoxicillin Micro Labs 250 mg amoxicillin
Slovenian: Amoxicillin Micro Labs 250 mg amoksicilin
English: 20 mg Capsule
Slovenian: 20 mg Kapsula
English: Irbesartan / Hydrochlorothiazide Micro Labs 300 mg /25 mg Filmtabletten irbesartan/ hydrochlorothiazide
Slovenian: Irbesartan / Hydrochlorothiazide Micro Labs 300 mg /25 mg Filmtabletten irbesartan/ hidroklorotiazid
English: Denmark Orifarm Generics A/S
Slovenian: Norveška Orifarm Generics A/S
English: 25 mg Capsule, hard Oral use
Slovenian: 25 mg Kapsula, trda Peroralna uporaba
English: 60 mg Capsule
Slovenian: 60 mg Kapsula
English: 30 mg Capsule
Slovenian: 30 mg Kapsula
English: Hydrochlorothiazide Micro Labs 150 mg/12.5 mg Filmtabletten irbesartan/ hydrochlorothiazide
Slovenian: Hydrochlorothiazide Micro Labs 150 mg/12.5 mg Filmtabletten irbesartan/ hidroklorotiazid
English: Amoxicillin Micro Labs 500 mg amoxicillin
Slovenian: Amoxicillin Micro Labs 500 mg amoksicilin
English: Celecoxib Glenmark 200 mg Hartkapseln celecoxib
Slovenian: Celecoxib Glenmark 200 mg Hartkapseln celekoksib
English: Celecoxib Glenmark 100 mg Hartkapseln celecoxib
Slovenian: Celecoxib Glenmark 100 mg Hartkapseln celekoksib
English: Celecoxib axcount 100 mg Hartkapseln celecoxib
Slovenian: Celecoxib axcount 100 mg Hartkapseln celekoksib
English: Celecoxib axcount 200 mg Hartkapseln celecoxib
Slovenian: Celecoxib axcount 200 mg Hartkapseln celekoksib
English: Hydrochlorothiazide Micro Labs 300 mg/12.5 mg Filmtabletten irbesartan/ hydrochlorothiazide
Slovenian: Hydrochlorothiazide Micro Labs 300 mg/12.5 mg Filmtabletten irbesartan/ hidroklorotiazid
English: Etoricoxib PhaRes 120 mg Filmtabletten etoricoxib
Slovenian: Etoricoxib PhaRes 120 mg Filmtabletten etorikoksib
English: 40 mg Capsule
Slovenian: 40 mg Kapsula
English: Irbesartan/Hydrochlorot hiazide Brown & Burk 150mg/12.5mg Filmcoated tablets irbesartan/ hydrochlorothiazide
Slovenian: Irbesartan/Hydrochlorot hiazide Brown & Burk 150mg/12.5mg Filmcoated tablets irbesartan/ hidroklorotiazid
English: Saquinavir Sandoz saquinavir
Slovenian: SAQUINAVIR SANDOZ sakvinavir
English: SAQUINAVIR SANDOZ saquinavir
Slovenian: Saquinavir Sandoz sakvinavir
English: Etoricoxib PhaRes 30 mg Filmtabletten etoricoxib
Slovenian: Etoricoxib PhaRes 30 mg Filmtabletten etorikoksib
English: Etoricoxib PhaRes 90 mg Filmtabletten etoricoxib
Slovenian: Etoricoxib PhaRes 90 mg Filmtabletten etorikoksib
English: 20 mg Capsule, hard Oral use
Slovenian: 20 mg Kapsula, trda Peroralna uporaba
English: Etoricoxib PhaRes 60 mg Filmtabletten etoricoxib
Slovenian: Etoricoxib PhaRes 60 mg Filmtabletten etorikoksib
English: Irbesartan/Hydrochlorot hiazide Brown & Burk 300mg/12.5mg Filmcoated tablets irbesartan/ hydrochlorothiazide
Slovenian: Irbesartan/Hydrochlorot hiazide Brown & Burk 300mg/12.5mg Filmcoated tablets irbesartan/ hidroklorotiazid
English: Irbesartan/Hydrochlorot hiazide Brown & Burk 300mg/25mg Filmcoated tablets irbesartan/ hydrochlorothiazide
Slovenian: Irbesartan/Hydrochlorot hiazide Brown & Burk 300mg/25mg Filmcoated tablets irbesartan/ hidroklorotiazid
English: 60 mg Capsule, hard Oral use
Slovenian: 60 mg Kapsula, trda Peroralna uporaba
English: Duloxetin-Hormosan 30 mg magensaftresistente Hartkapseln duloxetine
Slovenian: Duloxetin-Hormosan 30 mg magensaftresistente Hartkapseln duloksetin
English: 100 mg Capsule, hard Oral use
Slovenian: 100 mg Kapsula, trda Peroralna uporaba
English: 30 mg Capsule, hard Oral use
Slovenian: 30 mg Kapsula, trda Peroralna uporaba
English: Duloxetine Lupin 60mg GR capsules duloxetine
Slovenian: Duloxetine Lupin 60mg GR capsules duloksetin
English: Duloxetin-Hormosan 20 mg magensaftresistente Hartkapseln duloxetine
Slovenian: Duloxetin-Hormosan 20 mg magensaftresistente Hartkapseln duloksetin
English: Duloxetin-Hormosan 60 mg magensaftresistente Hartkapseln duloxetine
Slovenian: Duloxetin-Hormosan 60 mg magensaftresistente Hartkapseln duloksetin
English: Duloxetin-Hormosan 40 mg magensaftresistente Hartkapseln duloxetine
Slovenian: Duloxetin-Hormosan 40 mg magensaftresistente Hartkapseln duloksetin
English: Duloxetine Lupin 20mg GR capsules duloxetine
Slovenian: Duloxetine Lupin 20mg GR capsules duloksetin
English: Duloxetine Lupin 30mg GR capsules duloxetine
Slovenian: Duloxetine Lupin 30mg GR capsules duloksetin
English: 40 mg Capsule, hard Oral use
Slovenian: 40 mg Kapsula, trda Peroralna uporaba
English: Duloxetine Lupin 40mg GR capsules duloxetine
Slovenian: Duloxetine Lupin 40mg GR capsules duloksetin
English: S.C. BIO EEL S.R.L.
Slovenian: BIO EEL S.R.L.
English: LABORATORIO Dr. ESTEVE, S.A.
Slovenian: LABORATORIO Dr. ESTEVE, S.A. Avda.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for all authorised methadone medicinal products for oral use containing povidone
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
English: METADON BIOEEL
Slovenian: METADON BIOEEL methadone
English: Martindale Pharmaceuticals Ltd. Bampton Road Harold Hill
Slovenian: Velika Britanija Martindale Pharmaceuticals Ltd. Bampton Road
English: Metadon-EP 20 mg methadone
Slovenian: Metadon-EP 20 mg tabletta
English: Metadon-EP 5 mg methadone
Slovenian: Metadon-EP 5 mg tabletta
English: Avda.
Slovenian: S.C.
English: Procedure Management and Business Support
Slovenian: imetnikov dovoljenja za promet z zdravilom v državah članicah
English: on 24 July 2009.
Slovenian: dne 24 julija 2009.
English: Ref.: EMEA/356093/2009 EMEA/H/C/1031
Slovenian: : EMEA/484284/2009 EMEA/H/C/1031
English: Treatment may continue until the disease gets worse.
Slovenian: Zdravljenje lahko nadaljujemo, dokler se stanje bolezni ne poslabša.
English: This is repeated every 21 days for six courses or until the disease gets worse.
Slovenian: To ponovimo na vsakih 21 dni in vsega skupaj šest krat ali dokler se stanje bolezni ne poslabša.
English: Infusions should be carried out in a specialised cancer ward.
Slovenian: Infuzije je treba izvajati na specializiranem oddelku za zdravljenje raka.
English: Topotecan Actavis topotecan EPAR summary for the public
Slovenian: Topotecan Actavis topotekan Povzetek EPAR za javnost
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Topotecan Actavis has been shown to be comparable to Hycamtin.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Topotecan Actavis primerljivo z zdravilom Hycamtin.
English: This means that Topotecan Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Hycamtin.
Slovenian: To pomeni, da je zdravilo Topotecan Actavis podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Hycamtin.
English: Treatment with Topotecan Actavis should only be given under the supervision of a doctor experienced in the use of chemotherapy.
Slovenian: Zdravljenje z zdravilom Topotecan Actavis lahko poteka samo pod nadzorom zdravnika, izkušenega v uporabi kemoterapije.
English: It is also used together with cisplatin (another anticancer medicine) to treat women with cancer of the cervix, when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (stage IVB: the cancer has spread beyond the cervix).
Slovenian: Zdravilo se uporablja tudi skupaj z zdravilom cisplatin (drugim zdravilom proti raku) za zdravljenje žensk z rakom materničnega vratu, če se je rak znova pojavil po že končanem zdravljenju z obsevanjem ali če je bolezen v naprednem stadiju (stadij IVB: rak se je že razširil izven materničnega vratu).
English: The patient's blood levels of white blood cells, platelets and haemoglobin should be checked before treatment, to ensure that they are above set minimum levels.
Slovenian: Pred zdravljenjem je treba preveriti ravni belih krvnih celic, trombocitov in hemoglobina bolnika, da bi se prepričali, ali so te večje od najnižjih določenih ravni.
English: This prevents the cancer cells from dividing and they eventually die.
Slovenian: To preprečuje delitev rakavih celic in pripelje do njihovega postopnega odmrtja.
English: Other information about Topotecan Actavis:
Slovenian: Druge informacije o zdravilu Topotecan Actavis:
English: The Committee recommended that Topotecan Actavis be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Topotecan Actavis odobri dovoljenje za promet.
English: For lung cancer, Topotecan Actavis is given every day for five days with a three-week interval between the start of each course.
Slovenian: Pri pljučnem raku se zdravilo Topotecan Actavis daje vsak dan v trajanju pet dni, čemur sledi tritedenski premor pred pričetkom novega ciklusa zdravljenja.
English: Because Topotecan Actavis is a generic medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Slovenian: Ker je zdravilo Topotecan Actavis generično zdravilo, se šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The dose of Topotecan Actavis to be used depends on the type of cancer that it is being used to treat and the patient's weight and height.
Slovenian: Odmerek zdravila Topotecan Actavis je odvisen od vrste raka, ki ga zdravimo, in bolnikove telesne mase in višine.
English: When the enzyme is blocked, the DNA strands break.
Slovenian: S tem ko zaustavimo delovanje encima, začnejo verige DNK razpadati.
English: What are the benefit and risk of Topotecan Actavis?
Slovenian: Kakšne so koristi in tveganja, povezana z zdravilom Topotecan Actavis?
English: It blocks an enzyme called topoisomerase I, which is involved in the division of DNA.
Slovenian: Zdravilo zavira encim, imenovan topoizomeraza I, ki sodeluje v procesu delitve DNK.
English: Therefore, the CHMP's view was that, as for Hycamtin, the benefit outweighs the identified risk.
Slovenian: Zato je CHMP menil, da njegove koristi, tako kot pri zdravilu Hycamtin, odtehtajo znana tveganja.
English: Because Topotecan Actavis is a generic medicine, the company has provided data from the published literature on topotecan.
Slovenian: Ker je zdravilo Topotecan Actavis generično zdravilo, je družba predložila podatke iz objavljene literature o učinkovini topotekan.
English: Topotecan Actavis also affects non-cancer cells, which causes side effects.
Slovenian: Zdravilo Topotecan Actavis vpliva tudi na nerakave celice, kar povzroča neželene učinke.
English: When used with cisplatin in cervical cancer, Topotecan Actavis is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1).
Slovenian: Kadar zdravilo Topotecan Actavis uporabljamo skupaj s cisplatinom za zdravljenje raka materničnega vratu, ga dajemo v obliki infuzije na 1., 2. in 3. dan ciklusa (cisplatin damo na 1. dan).
English: The European Commission granted a marketing authorisation valid throughout the EU for Topotecan Actavis to Actavis Group PTC ehf.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Topotecan Actavis, veljavno po vsej Evropski uniji, odobrila družbi Actavis Group PTC ehf.
English: It is used on its own to treat patients with small cell lung cancer, when the cancer has relapsed (come back).
Slovenian: Uporablja se samostojno za zdravljenje bolnikov z drobnoceličnim rakom pljuč, pri katerih se rakavo obolenje ponovi.
English: Topotecan Actavis is a ‘generic medicine'.
Slovenian: Zdravilo Topotecan Actavis je „generično zdravilo“.
English: The active substance in Topotecan Actavis, topotecan, is an anticancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Slovenian: Zdravilna učinkovina v zdravilu Topotecan Activis, topotekan, je zdravilo proti raku, ki spada v skupino zaviralcev topoizomeraze.
English: Topotecan Actavis is an anticancer medicine.
Slovenian: Topotecan Actavis je zdravilo proti raku.
English: Topotecan Actavis is a powder to be made up into a solution for infusion (drip into a vein).
Slovenian: Zdravilo Topotecan Actavis je prašek za pripravo raztopine za infundiranje (kapalno infuzijo v veno).
English: Why has Topotecan Actavis been approved?
Slovenian: Zakaj je bilo zdravilo Topotecan Acatvis odobreno?
English: The full EPAR for Topotecan Actavis can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Topotecan Actavis je na voljo tukaj.
English: The doses may need to be adjusted or other medicines given to the patients, when the level of white blood cells remains particularly low.
Slovenian: Če je raven belih krvnih celic še posebej nizka, moramo odmerke prilagoditi ali bolniku začeti dajati druga zdravila.
English: No additional studies were needed as Topotecan Actavis is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Slovenian: Ker je zdravilo Topotecan Actavis generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Hycamtin, niso bile potrebne nobene dodatne študije.
English: What is Topotecan Actavis?
Slovenian: Kaj je zdravilo Topotecan Actavis?
English: What is Topotecan Actavis used for?
Slovenian: Za kaj se zdravilo Topotecan Actavis uporablja?
English: How is Topotecan Actavis used?
Slovenian: Kako se zdravilo Topotecan Actavis uporablja?
English: How has Topotecan Actavis been studied?
Slovenian: Kako je bilo zdravilo Topotecan Acatvis raziskano?
English: How does Topotecan Actavis work?
Slovenian: Kako zdravilo Topotecan Activis deluje?
English: It is usually confined to a single limb.
Slovenian: Običajno je omejen na eno okončino.
English: The final stage of the review procedure was the adoption by the European Commission of a legally binding decision applicable in all EU Member States on 12/01/2016.
Slovenian: Končna faza postopka pregleda je bilo sprejetje pravno zavezujoče odločbe s strani Evropske komisije, ki stopi v veljavo v vseh državah članicah EU dne 12/01/2016.
English: The review of HPV vaccines was initiated on 9 July 2015 by the European Commission at the request of Denmark, under Article 20 of Regulation (EC) No 726/2004.
Slovenian: Pregled cepiv proti virusu HPV je Evropska komisija pričela 9. julija 2015 na zahtevo Danske v skladu z 20. členom Uredbe (ES) št. 726/2004.
English: In some patients they can severely affect the quality of life.
Slovenian: Pri nekaterih bolnikih lahko resno vplivata na kakovost življenja.
English: The assessment report containing the evidence supporting the Agency's review is available on EMA's website.
Slovenian: Poročilo o oceni z dokazi, ki podpirajo pregled agencije, je na voljo na spletni strani agencije EMA.
English: • Patients or families who have any concerns should consult their healthcare professional.
Slovenian: • Bolniki ali družine, ki jih kar koli skrbi, naj se posvetujejo z zdravnikom.
English: Following their approval, the vaccines have been introduced in national immunisation programs in many countries.
Slovenian: Po odobritvi so cepiva uvedli v državne programe cepljenja v številnih državah.
English: The syndromes are recognised to occur in the general population, including adolescents, regardless of vaccination.
Slovenian: Znano je, da se sindroma pojavljata med splošnim prebivalstvom, vključno z mladostniki, ne glede na cepljenje.