FrancophonIA/ELRC3.0 huggingface dataset:
English: Glustin must not be used in patients who have problems with their liver, patients who have had heart failure (when the heart does not work as well as it should) or patients with diabetic ketoacidosis (a complication of diabetes).
Slovenian: Prav tako ga ne smejo uporabljati bolniki, ki imajo težave z jetri, bolniki s srčnim popuščanjem (pri katerih srce ne deluje, kot bi moralo) ali bolniki z diabetično ketoacidozo (zapletom pri sladkorni bolezni).
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 Glustin.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Glustin, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Glustin is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Slovenian: Zdravilo Glustin se uporablja za zdravljenje sladkorne bolezni tipa 2 pri odraslih (starejših od 18 let), zlasti tistih s prekomerno telesno maso.
English: The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Slovenian: V študijah so merili raven snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako dobro je raven glukoze v krvi uravnana.
English: The company that markets Glustin will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Slovenian: V njem bodo opisani možna tveganja za srčno popuščanje in raka sečnega mehurja pri zdravljenju s pioglitazonom, merila za izbiro bolnikov in potrebe po redni oceni zdravljenja ter prekinitev zdravljenja, če bolnikom ne koristi več.
English: This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed.
Slovenian: Priporočeni začetni odmerek zdravila Glustin je 15 ali 30 mg enkrat na dan. Odmerek bo po enem ali dveh tednih morda treba povečati do 45 mg enkrat na dan, če je potrebno boljše uravnavanje glukoze (sladkorja) v krvi.
English: • on its own in patients for whom metformin (another diabetes medicine) is not suitable;
Slovenian: • kot samostojno zdravilo pri bolnikih, za katere metformin (drugo zdravilo za zdravljenje sladkorne bolezni) ni primeren;
English: Glustin also improved the glucose control obtained in type 2 diabetes when it was added to existing treatment with a sulphonylurea, insulin or metformin, or the combination of metformin and a sulphonylurea.
Slovenian: Zdravilo Glustin je izboljšalo tudi uravnavanje glukoze pri sladkorni bolezni tipa 2, če je bilo dodano obstoječemu zdravljenju s sulfonilsečnino, insulinom ali metforminom ali kombinaciji metformina in sulfonilsečnine.
English: • together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite treatment with two medicines by mouth;
Slovenian: • skupaj z metforminom in sulfonilsečnino pri bolnikih, pri katerih kljub peroralnemu zdravljenju z obema zdraviloma ni vzpostavljeno zadovoljivo uravnavanje;
English: Why has Glustin been approved?
Slovenian: Zakaj je bilo zdravilo Glustin odobreno?
English: Some studies also looked at combining Glustin with a sulphonylurea, insulin or metformin, or with the combination of metformin and a sulphonylurea.
Slovenian: V nekaterih študijah so proučevali tudi kombiniranje zdravila Glustin s sulfonilsečnino, insulinom ali metforminom ali s kombinacijo metformina in sulfonilsečnine.
English: For the full list of all side effects reported with Glustin, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Glustin, glejte navodilo za uporabo.
English: • in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of diabetes medicine) when metformin is not suitable in patients who are not satisfactorily controlled on a sulphonylurea alone;
Slovenian: • v kombinaciji z metforminom pri bolnikih, pri katerih zgolj z metforminom ni mogoče doseči zadovoljivega uravnavanja ali s sulfonilsečnino (drugo vrsto zdravila za zdravljenje sladkorne bolezni), če metformin ni primeren, pri bolnikih, pri katerih zgolj s sulfonilsečnino ni mogoče doseči zadovoljivega uravnavanja;
English: • together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Slovenian: • skupaj z insulinom pri bolnikih, pri katerih bolezen ni zadostno uravnavana zgolj z insulinom in za katere metformin ni primeren.
English: At subsequent reviews prescribers should confirm that benefits to patients are maintained.
Slovenian: Pri nadaljnjih pregledih morajo zdravniki, ki zdravilo predpisujejo, preveriti, ali zdravilo še vedno zagotavlja enake koristi.
English: Glustin led to a decrease in the level of HbA1c, indicating that blood glucose levels had been reduced at doses of 15, 30 and 45 mg. Glustin on its own was shown to be as effective as metformin and gliclazide.
Slovenian: Zdravilo Glustin je povzročilo znižanje ravni HbA1c, kar pomeni, da so je raven glukoze v krvi znižala pri odmerkih 15 mg, 30 mg in 45 mg.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Glustin have also been included in the summary of product characteristics and the package leaflet.
Slovenian: V povzetek glavnih značilnosti zdravila in navodilo za uporabo so bili vključeni priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki za varno in učinkovito uporabo zdravila Glustin.
English: Glustin has been compared with placebo (a dummy treatment), metformin and gliclazide (a sulphonylurea) in a number of studies.
Slovenian: Zdravilo Glustin so v številnih študijah primerjali s placebom (zdravilom brez zdravilne učinkovine), metforminom ali gliklazidom (sulfonilsečnino).
English: What is Glustin used for?
Slovenian: Za kaj se zdravilo Glustin uporablja?
English: How has Glustin been studied?
Slovenian: Kako je bilo zdravilo Glustin raziskano?
English: What is Glustin?
Slovenian: Kaj je zdravilo Glustin?
English: How is Glustin used?
Slovenian: Kako se zdravilo Glustin uporablja?
English: How does Glustin work?
Slovenian: Kako zdravilo Glustin deluje?
English: 6 Month 20191
Slovenian: 6 May 20191
English: Mean follow-up was 569 days.
Slovenian: Povprečno trajanje spremljanja je bilo 569 dni.
English: Adopted at the 8-11 April 2019 PRAC
Slovenian: Sprejeto na seji odbora PRAC od 8. do 11. aprila 2019
English: It is not known if your medicine may harm your unborn baby.
Slovenian: Ni znano, ali zdravilo škodi nerojenemu otroku.
English: [Product name] should not be used during pregnancy.
Slovenian: Zdravilo [ime zdravila] se ne sme uporabljati med nosečnostjo.
English: These may cause increased blood levels of [active substance].
Slovenian: Povečajo lahko ravni [učinkovine] v krvi.
English: As modafinil may reduce the effectiveness of oral contraception alternative additional methods of contraception are required (see sections 4.4 and 4.5).
Slovenian: Ker lahko modafinil zmanjša učinkovitost peroralne kontracepcije, so zahtevane dodatne alternativne kontracepcijske metode (glejte poglavji 4.4 in 4.5).
English: What you need to know before you take Eliquis/Lixiana/Roteas Warnings and precautions
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Eliquis/Lixiana/Roteas Opozorila in previdnostni ukrepi
English: The trial was terminated prematurely after the enrolment of 120 patients due to an excess of events among patients in the rivaroxaban arm.
Slovenian: Preskušanje so po vključitvi 120 bolnikov predčasno prekinili zaradi prevelikega števila dogodkov pri bolnikih v skupini, ki je prejemala rivaroksaban.
English: 59 patients were randomized to rivaroxaban 20 mg (15 mg for patients with creatinine clearance (CrCl) <50 mL/min) and 61 to warfarin (INR 2.0- 3.0).
Slovenian: 59 bolnikov so randomizirali na rivaroksaban v jakosti 20 mg (15 mg pri bolnikih s kreatininskim očistkom (CrCl) < 50 ml/min), 61 pa na varfarin (INR 2,0-3,0).
English: Women of childbearing potential have to use effective contraception.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem uporabljati učinkovito kontracepcijo.
English: Modafinil is not recommended for use during pregnancy or in women of childbearing potential unless they are using effective contraception.
Slovenian: Uporaba modafinila ni priporočljiva med nosečnostjo ali pri ženskah v rodni dobi, katere ne uporabljajo učinkovite kontracepcije.
English: Modafinil - Evaluation of data on foetal outcomes including congenital anomalies from a single observational study in the US (EPITT no 19367)
Slovenian: Modafinil - ovrednotenje podatkov o izidih pri plodu, vključno s prirojenimi nepravilnostmi, iz opazovalne študije v ZDA (št. EPITT 19367)
English: Based on limited human experience from a pregnancy registry and spontaneous reporting modafinil is suspected to cause congenital malformations when administered during pregnancy.
Slovenian: Na podlagi omejenih izkušenj pri človeku iz registra nosečnosti in spontanih poročil obstaja sum, da modafinil v primeru uporabe med nosečnostjo povzroča prirojene malformacije.
English: A reduction in the dose of [active substance] may be necessary based on monitoring of side-effects during concomitant treatment (see section 4.4).
Slovenian: Morda je na podlagi spremljanja neželenih učinkov med sočasnim zdravljenjem potrebno zmanjšanje odmerka [učinkovine] (glejte poglavje 4.4).
English: What you need to know before you take [product name] Pregnancy and breast-feeding
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo [ime zdravila] Nosečnost in dojenje
English: What you need to know before you take Xarelto/Pradaxa Take special care with Xarelto/Pradaxa - if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Xarelto/Pradaxa Bodite posebno pozorni pri jemanju zdravila Xarelto/Pradaxa - če veste, da imate bolezen, imenovano antifosfolipidni sindrom (bolezen imunskega sistema, zaradi katere imate povečano tveganje za nastanek krvnih strdkov), o tem obvestite zdravnika, ki bo presodil, ali je treba zdravljenje spremeniti.
English: Rivaroxaban/dabigatran etexilate
Slovenian: Rivaroksaban/dabigatran eteksilat
English: Thromboembolic events occurred in 12% of patients randomized to rivaroxaban (4 ischaemic strokes and 3 myocardial infarctions).
Slovenian: Trombembolični dogodki so se pojavili pri 12 % bolnikov, randomiziranih na rivaroksaban (4 ishemične možganske kapi in 3 miokardni infarkti).
English: No events were reported in patients randomized to warfarin.
Slovenian: Pri bolnikih, randomiziranih na varfarin, niso poročali o nobenem dogodku.
English: Modafinil is suspected to cause birth defects if taken during pregnancy.
Slovenian: Obstaja sum, da modafinil povzroča prirojene nepravilnosti, če se jemlje med nosečnostjo.
English: In an investigator sponsored, randomized open-label multicenter study with blinded endpoint adjudication, rivaroxaban was compared to warfarin in patients with a history of thrombosis, diagnosed with antiphospholipid syndrome and at high risk for thromboembolic events (positive for all 3 antiphospholipid tests: lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies).
Slovenian: V randomizirani, odprti multicentrični študiji s slepo presojo opazovanega dogodka, ki so jo sponzorirali raziskovalci, so rivaroksaban primerjali z varfarinom pri bolnikih z anamnezo tromboze in diagnozo antifosfolipidnega sindroma ter z visokim tveganjem za trombembolične dogodke (pozitivnih pri vseh treh antifosfolipidnih preiskavah: za lupusni antikoagulant, protitelesa proti kardiolipinu in protitelesa proti beta 2-glikoproteinu I).
English: What you need to know before you take [Product name] Other medicines and [Product name]
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo [ime zdravila]
English: Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke).
Slovenian: Cimetidin, lansoprazol in omeprazol (ki se uporabljajo za zdravljenje želodčnih razjed), flukonazol (ki se uporablja za zdravljenje glivičnih okužb), fluvoksamin (antidepresiv) in tiklopidin (ki se uporablja za zmanjševanje tveganja za možgansko kap).
English: Major bleeding occurred in 4 patients (7%) of the rivaroxaban group and 2 patients (3%) of the warfarin group.
Slovenian: V skupini, ki je prejemala rivaroksaban, se je večja krvavitev pojavila pri 4 bolnikih (7 %), v skupini, ki je prejemala varfarin, pa pri 2 bolnikih (3 %).
English: In particular for patients that are triple positive (for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies), treatment with DOACs could be associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.
Slovenian: Zlasti pri trojno pozitivnih bolnikih (za lupusni antikoagulant, protitelesa proti kardiolipinu in protitelesa proti beta 2-glikoproteinu I) je zdravljenje s peroralnimi antikoagulanti z neposrednim delovanjem v primerjavi z zdravljenjem z antagonisti vitamina K lahko povezano s povečano pogostnostjo ponavljajočih se trombotičnih dogodkov.
English: Selective serotonin reuptake inhibitors: citalopram; escitalopram - Drug interaction with fluconazole (EPITT no
Slovenian: Selektivni zaviralci ponovnega privzema serotonina: citalopram; escitalopram - medsebojno delovanje s flukonazolom (št. EPITT 19327)
English: 4.5 Interaction with other medicinal products and other forms of interaction Thus, caution should be exercised when used concomitantly with CYP2C19 inhibitors (e.g. omeprazole, esomeprazole, fluconazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine.
Slovenian: Zato je potrebna previdnost, kadar se uporablja sočasno z zaviralci CYP2C19 (npr. omeprazolom, esomeprazolom, flukonazolom, fluvoksaminom, lansoprazolom, tiklopidinom) ali cimetidinom.
English: Direct-acting oral anticoagulants (DOACs): apixaban; dabigatran etexilate; edoxaban; rivaroxaban - Recurrent thrombosis in patients with antiphospholipid syndrome (EPITT no 19320)
Slovenian: Peroralni antikoagulanti z neposrednim delovanjem: apiksaban, dabigatran eteksilat, edoksaban, rivaroksabanponavljajoča se tromboza pri bolnikih z antifosfolipidnim sindromom (št. EPITT 19320)
English: Direct acting Oral Anticoagulants (DOACs) including rivaroxaban/apixaban/edoxaban/dabigatran etexilate are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.
Slovenian: Uporaba peroralnih antikoagulantov z neposrednim delovanjem, vključno z rivaroksabanom/apiksabanom/edoksabanom/dabigatran eteksilatom, pri bolnikih z anamnezo tromboze in diagnozo antifosfolipidnega sindroma ni priporočljiva.
English: There is limited data on the use of modafinil in pregnant women.
Slovenian: Plodnost, nosečnost in dojenje Podatkov o uporabi modafinila pri nosečnicah je malo.
English: If you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.
Slovenian: Bodite posebno pozorni pri jemanju zdravila Eliquis/Lixiana/Roteas Če veste, da imate bolezen, imenovano antifosfolipidni sindrom (bolezen imunskega sistema, zaradi katere imate povečano tveganje za nastanek krvnih strdkov), o tem obvestite zdravnika, ki bo presodil, ali je treba zdravljenje spremeniti.
English: Apixaban/edoxaban
Slovenian: Rivaroksaban
English: Take special care with Eliquis/Lixiana/Roteas
Slovenian: Apiksaban/edoksaban
English: An updated RMP shall be submitted by 31 October 2019.
Slovenian: Posodobljen RMP je treba predložiti do 31. oktobra 2019.
English: Tumour size 2 cm >2 cm
Slovenian: Velikost tumorja  2 cm > 2 cm
English: 75008 Paris
Slovenian: 75008 Pariz
English: (Harbor Park) 1, Campona utca Budapest 1225
Slovenian: (Harbor Park) 1, Campona utca Budimpešta 1225
English: Harmful for those suffering from alcoholism.
Slovenian: Škodljivo je za osebe, ki trpijo za alkoholizmom.
English: • change or absence of menstrual period
Slovenian: • spremembe ali izostanek menstruacije
English: a From the GETUG AFU15 study
Slovenian: a Iz študije GETUG AFU15.
English: (listed in section 6).
Slovenian: (navedeno v poglavju 6).
English: None of these increases in frequency reached 10% difference with the control arm.
Slovenian: Nobeno od teh povečanj pogostnosti ni doseglo 10-odstotne razlike v primerjavi s kontrolno skupino.
English: Each box contains one vial.
Slovenian: Vsaka škatla vsebuje eno vialo.
English: (26.8-ne) TTP = time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
Slovenian: ČDN = čas do napredovanja; “no” pomeni, ni bilo mogoče oceniti ali še ni doseženo.
English: • if the number of white blood cells is too low.
Slovenian: • če imate premajhno število belih krvnih celic.
English: Patients should be informed about the signs and symptoms of serious skin manifestations and closely monitored.
Slovenian: Bolnike je treba seznaniti z znaki in simptomi resnih kožnih manifestacij in jih skrbno spremljati.
English: • 2 years.
Slovenian: • 2 leti.
English: Alopecia (persisting:
Slovenian: Alopecija (persistentna:
English: STAMPEDE study
Slovenian: ŠTUDIJA STAMPEDE
English: The marketing authorisation holder shall submit PSUR for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: Imetnik dovoljenja za promet z zdravilom PSUR za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portal o zdravilih.
English: Other medicines and TAXOTERE
Slovenian: Druga zdravila in zdravilo TAXOTERE
English: The safety and efficacy of TAXOTERE in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila TAXOTERE za zdravljenje nazofaringealnega karcinoma pri otrocih od 1 meseca do manj kot 18 let starosti nista ugotovljeni.
English: You must not be given TAXOTERE:
Slovenian: Zdravila TAXOTERE ne smete dobiti:
English: Before each treatment with TAXOTERE, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive TAXOTERE.
Slovenian: Pred vsako uporabo zdravila TAXOTERE boste opravili preiskave krvi za ugotovitev, ali imate dovolj krvnih celic in zadostno delovanje jeter, da lahko dobite zdravilo TAXOTERE.
English: TAXOTERE will be given by infusion into one of your veins (intravenous use).
Slovenian: Zdravilo TAXOTERE boste dobili v infuziji v eno od ven (intravenska uporaba).
English: What you need to know before you use TAXOTERE
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo TAXOTERE
English: See accompanying preparation guide.
Slovenian: Glejte priložena navodila za pripravo.
English: G-CSF was used for secondary prophylaxis in 19.3% of patients (10.7% of the cycles).
Slovenian: G-CSF so uporabili za sekundarno profilakso pri 19,3 % bolnikov (10,7 % ciklusov).
English: TAXOTERE contains alcohol.
Slovenian: Zdravilo TAXOTERE vsebuje alkohol.
English: • decrease of the potassium, calcium and/or phosphate in your blood.
Slovenian: • znižanje kalija, kalcija in/ali fosfata v krvi.
English: Frequency not known (cannot be estimated from the available data):
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
English: CHAARTED study
Slovenian: ŠTUDIJA CHAARTED
English: • raised liver enzymes (hence the need for regular blood tests)
Slovenian: • zvečanje jetrnih encimov (zato so potrebne redne preiskave krvi)
English: However, the distribution of OS was not significantly different between the 2 groups.
Slovenian: Toda porazdelitev celotnega preživetja se med obema skupinama ni značilno razlikovala
English: Ask your doctor for advice before being given any medicine.
Slovenian: Posvetujte se z zdravnikom preden vzamete katerokoli zdravilo.
English: a Time to event variables: Stratified log-rank test.
Slovenian: a Spremenljivke časa do dogodka: stratificirani log-rang test.
English: Histological grade Grade1 (includes grade not assessed) Grade 2
Slovenian: Histološka stopnja 1. stopnja (vključuje primere z neocenjeno stopnjo)
English: Between infusions of TAXOTERE the following may occur, and the frequency may vary with the combinations of medicines that are received:
Slovenian: Med infuzijami zdravila TAXOTERE se lahko pojavi naslednje in pogostnost se lahko razlikuje glede na kombinacijo zdravil, ki so uporabljena:
English: RECOMMENDATIONS FOR THE SAFE HANDLING
Slovenian: PRIPOROČILA ZA VARNO RAVNANJE
English: Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to TAXOTERE.
Slovenian: Zdravnik bo morda spremenil odmerek in pogostnost odmerjanja glede na izvide vaših preiskav krvi, vaše splošno stanje in vaš odziv na zdravilo TAXOTERE.
English: Sanofi - Produtos Farmacêuticos, Lda.
Slovenian: Portugal Sanofi - Produtos Farmacêuticos, Lda
English: Meeting relative indication for chemotherapy a
Slovenian: Izpolnjena relativna indikacija za kemoterapijo a
English: The name of this medicine is TAXOTERE.
Slovenian: To zdravilo se imenuje TAXOTERE.
English: This is because TAXOTERE or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Slovenian: Bodisi zdravilo TAXOTERE bodisi drugo zdravilo namreč mogoče ne bo delovalo tako dobro, kot bi bilo pričakovati, in verjetneje je, da se bo pri vas pojavil kakšen neželen učinek.
English: Response rate variables: Fisher's Exact test * p-value for descriptive purpose.
Slovenian: Spremenljivke deleža odziva: Fisherjev eksaktni test. *Vrednost p za opisen namen.
English: TAXOTERE will be administered to you by a healthcare professional.
Slovenian: Zdravilo TAXOTERE vam bo dal pristojni zdravstveni delavec.
English: Time to clinical progressionc
Slovenian: Čas do kliničnega napredovanjac
English: Pharmacotherapeutic group: Taxanes, ATC Code: L01CD02
Slovenian: Farmakoterapevtska skupina: Taksani, oznaka ATC: L01CD02
English: TAXOTERE vials should be stored between 2°C and 25°C and protected from light.
Slovenian: Viale zdravila TAXOTERE morajo biti shranjene pri temperaturi med 2°C in 25°C in zaščitene pred svetlobo.
English: • infection of the upper respiratory tract.
Slovenian: • okužba zgornjih dihal.
English: Primary prophylactic G-CSF was made mandatory in TAC arm after 230 patients were randomised.
Slovenian: Primarna profilaktična uporaba G-CSF je postala v kraku TAC obvezna po randomizaciji 230 bolnic.
English: Use immediately the medicine once added into the infusion bag.
Slovenian: Zdravilo uporabite takoj potem, ko je dodano v infuzijsko vrečko.
English: Date of first authorisation: 27 November 1995 Date of latest renewal: 27 November 2005
Slovenian: Datum prve pridobitve dovoljenja za promet z zdravilom: 27 November 1995 Datum zadnjega podaljšanja: 27 November 2005
English: What TAXOTERE is and what it is used for
Slovenian: Kaj je zdravilo TAXOTERE in za kaj ga uporabljamo