FrancophonIA/ELRC3.0 huggingface dataset:
English: You must stop breast-feeding if you are to be given Simponi.
Slovenian: Če boste začeli prejemati zdravilo Simponi, morate nehati dojiti.
English: Simponi 50 mg solution for injection in pre-filled syringe 0.5 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex).
Slovenian: Simponi 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi 0,5 ml raztopine v napolnjeni injekcijski brizgi (brizga iz stekla tipa 1) s pritrjeno iglo (iz nerjavečega jekla) in ščitnikom igle (iz gume, ki vsebuje lateks).
English: Simponi 50 mg solution for injection in pre-filled syringe golimumab
Slovenian: Simponi 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku golimumab
English: Simponi 100 mg solution for injection in pre-filled pen Each 1 mL pre-filled pen contains 100 mg of golimumab*.
Slovenian: Simponi 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku En 1 ml napolnjen injekcijski peresnik vsebuje 100 mg golimumaba*.
English: EU/1/09/546/008 (3 packs, each containing 1 pre-filled syringe)
Slovenian: EU/1/09/546/008 (3 zavojčki, vsak z 1 napolnjeno injekcijsko brizgo)
English: Simponi 100 mg solution for injection in pre-filled syringe 1 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex).
Slovenian: Simponi 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi 1 ml raztopine v napolnjeni injekcijski brizgi (brizga iz stekla tipa 1) s pritrjeno iglo (iz nerjavečega jekla) in ščitnikom igle (iz gume, ki vsebuje lateks).
English: Very common: Upper respiratory tract infection (nasopharyngitis, pharyngitis, laryngitis and rhinitis) Common: Bacterial infections (such as cellulitis), lower respiratory tract infection (such as pneumonia), viral infections (such as influenza and herpes), bronchitis, sinusitis, superficial fungal infections, abscess
Slovenian: Preglednica 1 Seznam neželenih učinkov v preglednici Infekcijske in parazitske bolezni Zelo pogosti: okužbe zgornjih dihal (nazofaringitis, faringitis, laringitis in rinitis) Pogosti: bakterijske okužbe (npr. celulitis), okužba spodnjih dihal (npr. pljučnica), virusne okužbe (npr. gripa in herpes), bronhitis, sinusitis, površinske glivične okužbe, absces Občasni: sepsa, vključno s septičnim šokom, pielonefritis Redki: tuberkuloza, oportunistične okužbe (npr. invazivne glivne okužbe [histoplazmoza, kokcidioidomikoza, pnevmocitoza], bakterijske, atipične mikobakterijske okužbe ter okužbe s protozoji), reaktivacija hepatitisa B, bakterijski artritis, infekcijski bursitis
English: Among patients who remained on the Simponi treatment to which they were randomised at study start, DAS28 responses were maintained through week 104.
Slovenian: Med bolniki, na začetku študije naključno razporejenimi v skupino, ki je prejemala zdravilo Simponi, so se pri tistih, ki so se še naprej zdravili z zdravilom Simponi, odzivi DAS 28 ohranili vse do 104. tedna.
English: Do not remove the pre-filled syringe's needle cover while allowing it to reach room temperature.
Slovenian: Med čakanjem, da se napolnjena injekcijska brizga segreje na sobno temperaturo, z nje ne smete sneti pokrovčka.
English: Simponi 50 mg solution for injection in pre-filled pen 0.5 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex) in a pre-filled pen.
Slovenian: Simponi 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku 0,5 ml raztopine v napolnjeni injekcijski brizgi (brizga iz stekla tipa 1) s pritrjeno iglo (iz nerjavečega jekla) in ščitnikom igle (iz gume, ki vsebuje lateks) v napolnjenem injekcijskem peresniku.
English: before you begin using Simponi.
Slovenian: Če ste prenehali uporabljati zdravilo Simponi
English: Simponi 50 mg administered once a month, on the same date each month, for children with a body weight of at least 40 kg. A 45 mg/0.45 mL pre-filled pen is available for administration to children with polyarticular juvenile idiopathic arthritis weighing less than 40 kg.
Slovenian: Zdravilo Simponi 50 mg se uporablja enkrat na mesec, vsak mesec na isti datum, pri otrocih s telesno maso vsaj 40 kg.
English: One 0.5 mL pre-filled syringe contains 50 mg of golimumab.
Slovenian: Ena 0,5 ml napolnjena injekcijska brizga vsebuje 50 mg golimumaba.
English: Solution for injection in pre-filled syringe (injection)
Slovenian: raztopina za injiciranje v napolnjenem injekcijskem peresniku (injekcija), SmartJect raztopina za injiciranje v napolnjeni injekcijski brizgi (injekcija)
English: Statistically significant improvements in signs and symptoms of severe active nr-Axial SpA were demonstrated in patients treated with Simponi 50 mg compared to placebo at week 16 (Table 6).
Slovenian: Pri bolnikih, zdravljenih z zdravilom Simponi 50 mg, so v primerjavi s tistimi, ki so prejemali placebo, v 16. tednu ugotovili statistično značilno izboljšanje znakov in simptomov hudega aktivnega nr-aksialnega SpA (preglednica 6).
English: EU/1/09/546/003 1 pre-filled syringe EU/1/09/546/004 3 pre-filled syringes
Slovenian: EU/1/09/546/003 1 napolnjena injekcijska brizga EU/1/09/546/004 3 napolnjene injekcijske brizge
English: Simponi has minor influence on your ability to drive and use tools or machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Simponi ima majhen vpliv na sposobnost vožnje in uporabe orodij ali strojev.
English: A starting dose of 200 mg (the contents of 4 pre-filled syringes) followed by 100 mg (the contents of 2 pre-filled syringes) 2 weeks later.
Slovenian: Začetni odmerek 200 mg (vsebina 4 napolnjenih injekcijskih brizg), ki mu sledi 100 mg (vsebina 2 napolnjenih injekcijskih brizg) 2 tedna kasneje.
English: In general, no clinically meaningful differences in measures of efficacy were observed between the Simponi 50 mg and 100 mg dosing regimens with concomitant MTX, through week 104 in GO-FORWARD and GO-BEFORE and through week 24 in GO-AFTER.
Slovenian: V 104. tednu študij GO-FORWARD in GO-BEFORE ter 24. tednu študije GO-AFTER na splošno niso opazili nikakršnih klinično pomembnih razlik v merilih učinkovitosti med shemama odmerjanja zdravila Simponi s 50 mg ali 100 mg ob sočasnem jemanju MTX.
English: Check the liquid in the viewing window.
Slovenian: Skozi prikazovalno okence preverite tekočino.
English: One 0.45 mL pre-filled pen contains 45 mg of golimumab.
Slovenian: En 0,45-ml napolnjeni injekcijski peresnik vsebuje 45 mg golimumaba.
English: Solution for injection in pre-filled pen (SmartJect) 1 pre-filled pen
Slovenian: raztopina za injiciranje v napolnjenem injekcijskem peresniku (SmartJect) 1 napolnjen injekcijski peresnik
English: EU/1/09/546/004 (3 packs, each containing 1 pre-filled syringe)
Slovenian: EU/1/09/546/004 (3 zavojčki, vsak z 1 napolnjeno injekcijsko brizgo)
English: Prepare for your injection
Slovenian: Priprava za injiciranje
English: One 1 mL pre-filled syringe contains 100 mg of golimumab.
Slovenian: Ena 1 ml napolnjena injekcijska brizga vsebuje 100 mg golimumaba.
English: Uncommon: Breast disorders, menstrual disorders
Slovenian: Občasni: bolezni dojk, menstrualne motnje Splošne težave in spremembe na mestu aplikacije
English: One 0.5 mL pre-filled pen contains 50 mg of golimumab.
Slovenian: En 0,5 ml napolnjen napolnjen peresnik vsebuje 50 mg golimumaba.
English: golimumab 100 mg-treated subjects with an incidence (95% CI) per 100 subject-years of follow-up of 0.36 (0.26, 0.49) for combined golimumab and 0.87 (0.28, 2.04) for placebo.
Slovenian: Incidenca (95 % IZ) na 100 preiskovanec-let spremljanja je bila 0,03 dogodka (0,00, 0,15) za zdravljenje s 50 mg golimumaba, 0,13 dogodka (0,06, 0,24) za zdravljenje s 100 mg golimumaba in 0,00 dogodka (0,00, 0,57) za placebo.
English: A starting dose of 200 mg (the contents of 2 pre-filled syringes) followed by 100 mg (the contents of 1 pre-filled syringe) 2 weeks later.
Slovenian: Začetni odmerek 200 mg (vsebina 2 napolnjenih injekcijskih brizg), ki mu sledi 100 mg (vsebina 1 napolnjene injekcijske brizge) 2 tedna kasneje.
English: Your doctor may decide to prescribe 100 mg (the contents of 2 pre-filled syringes), depending on how well Simponi works for you.
Slovenian: Zdravnik se lahko odloči za odmerek 100 mg (vsebino 2 napolnjenih injekcijskih brizg), odvisno od tega, kako dobro deluje zdravilo Simponi pri vas.
English: Simponi 100 mg solution for injection in pre-filled pen 1 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex) in a pre-filled pen.
Slovenian: Simponi 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku 1 ml raztopine v napolnjeni injekcijski brizgi (brizga iz stekla tipa 1) s pritrjeno iglo (iz nerjavečega jekla) in ščitnikom igle (iz gume, ki vsebuje lateks) v napolnjenem injekcijskem peresniku.
English: 0.25 mL 0.3 mL
Slovenian: 0,25 ml
English: EU/1/09/546/005 1 pre-filled pen EU/1/09/546/006 3 pre-filled pens
Slovenian: EU/1/09/546/005 1 napolnjen injekcijski peresnik EU/1/09/546/006 3 napolnjeni injekcijski peresniki
English: Your doctor may decide to prescribe 100 mg (the contents of 1 pre-filled syringe) depending on how well Simponi works for you.
Slovenian: Zdravnik se lahko odloči za odmerek 100 mg (vsebino 1 napolnjene injekcijske brizge), odvisno od tega, kako dobro deluje zdravilo Simponi pri vas.
English: • Keep the pre-filled pen in the outer carton in order to protect it from light.
Slovenian: • Napolnjen injekcijski peresnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: SINGLE-USE
Slovenian: Način uporabe
English: Keep holding the pre-filled pen upright.
Slovenian: Trdno primite kožno gubo.
English: Talk to your doctor if you have any questions about giving yourself an injection.
Slovenian: Če imate kakršna koli vprašanja o injiciranju zdravila, se posvetujte z zdravnikom.
English: • In patients weighing less than 80 kg, 50 mg (the contents of 1 pre-filled syringe) 4 weeks after your last treatment, then every 4 weeks thereafter.
Slovenian: Vzdrževalno zdravljenje • Pri bolnikih, ki tehtajo manj kot 80 kg, 50 mg (vsebina 1 napolnjene injekcijske brizge) 4 tedne po zadnjem zdravljenju, nato vsake 4 tedne.
English: One 1 mL pre-filled pen contains 100 mg of golimumab.
Slovenian: En 1 ml napolnjen napolnjen peresnik vsebuje 100 mg golimumaba.
English: The incidence per 100 subject-years of all serious infections was 4.1; 95% CI: 3.6, 4.5, in patients receiving golimumab 100 mg and 2.5; 95% CI: 2.0, 3.1, in patients receiving golimumab 50 mg.
Slovenian: V kontroliranih in nekontroliranih delih ključnih preskušanj z medianim trajanjem spremljanja bolnikov do 3 let je bila incidenca resnih okužb, vključno z oportunističnimi okužbami in tuberkulozo, večja med bolniki, ki so prejemali golimumab v odmerku 100 mg, kot med tistimi, ki so prejemali golimumab v odmerku 50 mg. Incidenca vseh resnih okužb na 100 preiskovanec-let je bila 4,1; 95 % IZ: 3,6, 4,5, pri bolnikih, ki so prejemali golimumab v odmerku 100 mg, in 2,5; 95 % IZ: 2,0, 3,1, pri bolnikih, ki so prejemali golimumab v odmerku 50 mg.
English: 0.15 mL 0.2 mL
Slovenian: 0,15 ml
English: • In patients weighing 80 kg or more, 100 mg (the contents of 1 pre-filled syringe) 4 weeks after your last treatment, then every 4 weeks thereafter.
Slovenian: • Pri bolnikih, ki tehtajo 80 kg ali več, 100 mg (vsebina 1 napolnjene injekcijske brizge) 4 tedne po zadnjem zdravljenju, nato vsake 4 tedne
English: Preparing for use of the pre-filled pen
Slovenian: Priprava za uporabo napolnjenega injekcijskega peresnika
English: Use of anti-tuberculosis therapy should also be considered before the initiation of golimumab in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Slovenian: Tudi pri tistih bolnikih, ki so imeli v preteklosti latentno ali aktivno tuberkulozo in pri katerih ni mogoče potrditi ustreznega zdravljenja, je treba pred uvedbo zdravljenja z golimumabom premisliti o uporabi protituberkulozne terapije.
English: • Skin blisters
Slovenian: Kožni raki
English: EU/1/09/546/001 1 pre-filled pen EU/1/09/546/002 3 pre-filled pens
Slovenian: EU/1/09/546/001 1 napolnjen injekcijski peresnik EU/1/09/546/002 3 napolnjeni injekcijski peresniki
English: • In patients weighing 80 kg or more, 100 mg (the contents of 2 pre-filled syringes) 4 weeks after your last treatment, then every 4 weeks thereafter.
Slovenian: • Pri bolnikih, ki tehtajo 80 kg ali več, 100 mg (vsebina 2 napolnjenih injekcijskih brizg) 4 tedne po zadnjem zdravljenju, nato vsake 4 tedne
English: Make sure you dispose of the bin as instructed by your doctor or nurse when the container is full.
Slovenian: Ko je vsebnik poln, ga morate zavreči po navodilih, ki ste jih dobili od zdravnika ali medicinske sestre.
English: There were no patients age 45 and over in the nr-Axial SpA study.
Slovenian: V študiji nr-aksialnega SpA ni bilo bolnikov, starih 45 let ali več.
English: • Thyroid disorders
Slovenian: • bolezni jeter,
English: Viewing Window
Slovenian: Prikazoval no okence
English: Your doctor may decide to prescribe 100 mg (the contents of 1 pre-filled pen), depending on how well Simponi works for you.
Slovenian: Zdravnik se lahko odloči za odmerek 100 mg (vsebino 1 napolnjenega injekcijskega peresnika), odvisno od tega, kako dobro deluje zdravilo Simponi pri vas.
English: Simponi 50 mg solution for injection golimumab
Slovenian: Simponi 50 mg raztopina za injekcije golimumab s.c.
English: Simponi 100 mg solution for injection golimumab
Slovenian: Simponi 100 mg raztopina za injekcije golimumab s.c.
English: EU/1/09/546/006 (3 packs, each containing 1 pre-filled pen)
Slovenian: EU/1/09/546/006 (3 zavojčki, vsak z 1 napolnjenim injekcijskim peresnikom)
English: 0.35 mL 0.4 mL
Slovenian: 0,35 ml
English: Simponi 50 mg solution for injection in pre-filled syringe.
Slovenian: Simponi 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Simponi 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: EU/1/09/546/002 (3 packs, each containing 1 pre-filled pen)
Slovenian: EU/1/09/546/002 (3 zavojčki, vsak z 1 napolnjenim injekcijskim peresnikom)
English: • Blood clots
Slovenian: • krvni strdki,
English: Metabolism and nutrition disorders Uncommon: Blood glucose increased, lipids increased
Slovenian: Bolezni endokrinega sistema Občasni: bolezni ščitnice (npr. hipotiroza, hipertiroza in golša) Presnovne in prehranske motnje Občasni: zvečana vrednost glukoze v krvi, zvečana vrednost lipidov
English: Dizziness may however occur after you take Simponi.
Slovenian: Med uporabo zdravila Simponi se lahko vseeno pojavi omotica.
English: Simponi 100 mg solution for injection in pre-filled syringe.
Slovenian: Simponi 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Simponi 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Hold the pre-filled syringe by the body of the pre-filled syringe
Slovenian: Napolnjeno injekcijsko brizgo držite za trup.
English: A starting dose of 200 mg (the contents of 2 pre-filled pens) followed by 100 mg (the contents of 1 pre-filled pen) 2 weeks later.
Slovenian: Začetni odmerek 200 mg (vsebina 2 napolnjenih injekcijskih peresnikov), ki mu sledi 100 mg (vsebina 1 napolnjenega injekcijskega peresnika) 2 tedna kasneje.
English: Treatment may continue until the disease gets worse.
Slovenian: Zdravljenje se lahko nadaljuje, dokler se stanje bolezni ne poslabša.
English: Hycamtin topotecan
Slovenian: Hycamtin topotekan
English: It is used when giving the original treatment again is not recommended.
Slovenian: Uporablja se, kadar ponovna uporaba prvotnega zdravljenja ni priporočena.
English: This is repeated every 21 days for six courses or until the disease gets worse.
Slovenian: To je treba ponavljati vsakih 21 dni, vsega skupaj šestkrat ali dokler se bolezen ne poslabša.
English: The main measure of effectiveness was the number of patients whose tumours responded to treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, katerih tumorji so se odzvali na zdravljenje.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Hycamtin on 12 November 1996.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Hycamtin, veljavno po vsej Evropski uniji, izdala 12. novembra 1996.
English: Three studies were ‘open', meaning that the medicine was not compared to any other treatment and the patients knew that they were receiving Hycamtin.
Slovenian: Tri študije so bile „odprte“, kar pomeni, da zdravila niso primerjali z nobenim drugim zdravljenjem in da so bolniki vedeli, da prejemajo zdravilo Hycamtin.
English: What measures are being taken to ensure the safe and effective use of Hycamtin?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Hycamtin?
English: The full EPAR for Hycamtin 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 Hycamtin je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is used after at least one other treatment has failed;
Slovenian: Uporablja se, če je bil pred tem neučinkovit vsaj en drug način zdravljenja;
English: This is a summary of the European public assessment report (EPAR) for Hycamtin.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Hycamtin.
English: The most common side effects with Hycamtin (seen in more than 1 patient in 10) are neutropenia (low white blood cell counts), febrile neutropenia (neutropenia with fever), thrombocytopenia (low platelet counts), anaemia (low red blood cell counts), leucopenia (low white blood cell counts), nausea (feeling sick), vomiting and diarrhoea (all of which may be severe), constipation, abdominal (tummy) pain, mucositis (mouth sores), alopecia (hair loss), loss of appetite (which may be severe), infections, pyrexia (fever), asthenia (weakness) and fatigue (tiredness).
Slovenian: Najpogostejši neželeni učinki zdravila Hycamtin (opaženi pri več kot 1 bolniku od 10) so nevtropenija (nizke ravni belih krvnih celic), febrilna nevtropenija (nevtropenija, ki povzroča povišano telesno temperaturo), trombocitopenija (nizke ravni trombocitov), anemija (nizke ravni rdečih krvnih celic), levkopenija (nizke ravni belih krvnih celic), navzeja (slabost), bruhanje in driska (ki sta možni v hudi obliki), zaprtje, bolečine v trebuhu, mukozitis (vnetje sluznice v ustni votlini), alopecija (izpadanje las), izguba teka(ki je lahko resna), okužbe, pireksija (povišana telesna temperatura), astenija (šibkost) in utrujenost.
English: When the enzyme is blocked, the DNA strands break.
Slovenian: Ko je encim zavrt, začnejo verige DNK razpadati.
English: The effectiveness was measured by looking at overall survival.
Slovenian: Učinkovitost so merili s spremljanjem celokupne stopnje preživetja.
English: Other information about Hycamtin
Slovenian: Druge informacije o zdravilu Hycamtin
English: It was as effective as the standard combination chemotherapy.
Slovenian: Zdravilo je bilo enako učinkovito kot običajna kombinirana kemoterapija.
English: It is available as a powder to be made up into a solution for infusion (drip) into a vein and as capsules (0.25 and 1 mg).
Slovenian: Na voljo je v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije v veno) in v obliki kapsul (0,25 in 1 mg).
English: • metastatic cancer of the ovary (when the cancer has spread to other parts of the body).
Slovenian: • z metastatskim rakom jajčnikov (rakom, ki se je razširil na druge dele telesa).
English: This prevents the cancer cells from dividing and they eventually die.
Slovenian: To preprečuje delitev rakavih celic in povzroči njihovo postopno odmrtje.
English: The effectiveness was measured by looking at survival or response rates.
Slovenian: Učinkovitost so merili s spremljanjem stopnje preživetja ali odzivnosti.
English: A risk management plan has been developed to ensure that Hycamtin is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Hycamtin je bil pripravljen načrt obvladovanja tveganj.
English: Infusions should be carried out in a specialised cancer ward.
Slovenian: Infundiranje je treba izvajati na specializiranem oddelku za zdravljenje raka.
English: For more information about treatment with Hycamtin read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Hycamtin preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Hycamtin has also been studied in three main studies in 656 patients with relapsed small cell lung cancer.
Slovenian: Zdravilo Hycamtin so raziskovali tudi v treh glavnih študijah, ki so vključevale 656 bolnikov s ponovljenim drobnoceličnim pljučnim rakom.
English: What benefit has Hycamtin shown during the studies?
Slovenian: Kakšne koristi je zdravilo Hycamtin izkazalo med študijami?
English: It is also used together with cisplatin (another cancer 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 (has spread beyond the cervix).
Slovenian: Zdravilo se uporablja tudi skupaj z zdravilom cisplatin (drugo vrsto zdravila za zdravljenje raka) 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 (rak se je razširil zunaj materničnega vratu).
English: In cervical cancer, patients receiving the combination of Hycamtin and cisplatin survived an average of 9.4 months, compared with 6.5 months for the patients who received cisplatin only.
Slovenian: Bolnice z rakom materničnega vratu, ki so prejemale kombinacijo zdravil Hycamtin in cisplatin, so v povprečju preživele 9,4 meseca, v primerjavi s 6,5 meseca pri bolnicah, ki so prejemale le zdravilo cisplatin.
English: In the main study, 21% of the patients who received Hycamtin (23 out of 112) responded to treatment, compared with 14% of the paclitaxel patients (16 out of 114).
Slovenian: V glavni študiji se je 21 % (23 od 112) bolnic, ki so prejemale zdravilo Hycamtin, odzvalo na zdravljenje v primerjavi s 14 % (16 od 114) tistih, ki so se zdravile s paklitakselom.
English: For full details, see the summary of product characteristics, also part of the EPAR.
Slovenian: Za podrobnejše informacije glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: Treatment with Hycamtin should only be given under the supervision of a doctor experienced in the use of chemotherapy.
Slovenian: Zdravljenje z zdravilom Hycamtin lahko poteka samo pod nadzorom zdravnika, ki ima izkušnje z uporabo kemoterapije.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Hycamtin.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: In ovarian cancer, the studies showed the effectiveness of Hycamtin, with an overall response rate of about 16%.
Slovenian: Pri raku jajčnikov so študije pokazale učinkovitost zdravila Hycamtin, saj je bila celokupna odzivnost približno 16 %.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Hycamtin, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.