FrancophonIA/ELRC3.0 huggingface dataset:
English: Reconstituted solution is a clear colourless to light straw-coloured solution.
Slovenian: Rekonstituirana raztopina je bistra, brezbarvna do rahlo slamnato-obarvana raztopina.
English: This yields a gemcitabine concentration of 38 mg/ml, which includes accounting for the displacement volume of the lyophilised powder.
Slovenian: To daje koncentracijo gemcitabina 38 mg/ml, kar vključuje upoštevanje nadomestitve volumna liofiliziranega praška.
English: Suspension or modification of therapy should be considered when drug-induced bone marrow depression is detected (see section 4.2).
Slovenian: Ob zaznavi depresije kostnega mozga je potrebno razmisliti o prekinitvi ali spremembi terapije (glejte poglavje 4.2).
English: Pain, redness, swelling or sores in the mouth Itching
Slovenian: Bolečina, rdečina, otekline ali rane v ustih Srbenje
English: Peak plasma concentrations (3-15 minutes after end of 30-minute infusion, 1000 mg/m2): 28-52 µg/ml.
Slovenian: Farmakokinetika dFdU Najvišje plazemske koncentracije (3-15 minut po koncu 30-minutne infuzije, 1.000 mg/m površine telesa): 28-52 µg/ml.
English: Also, the use of Gemcitabine as a single agent in NSCLC was justified in specific situations.
Slovenian: Uspešno je zagovarjal tudi uporabo gemcitabina kot samostojnega sredstva pri zdravljenju NSCLC v posebnih primerih.
English: Lithuania Eli Lilly Holdings Limited Kingsclere Road, Basingstoke, Hampshire RG21 6XA United Kingdom
Slovenian: Eli Lilly Holdings Limited Kingsclere Road, Basingstoke, Hampshire RG21 6XA Velika Britanija
English: Fluid in the lungs
Slovenian: Tekočina v pljučih
English: Gemcitabine in combination with paclitaxel is recommended using paclitaxel (175 mg/m2) administered on Day 1 over approximately 3-hours as an intravenous infusion, followed by gemcitabine (1250 mg/m2) as a 30-minute intravenous infusion on Days 1 and 8 of each 21-day cycle.
Slovenian: Priporočamo gemcitabin v kombinaciji s paklitakselom, z uporabo paklitaksela (175 mg/m površine telesa) 1. dan, v obliki približno 3 urne kot intravenske infuzije, ki mu sledi gemcitabin (1.250 mg/m površine telesa) kot 30-minutna intravenska infuzija 1. in 8. dan vsakega 21-dnevnega ciklusa.
English: Grade 3 and 4 Adverse Events Carboplatin versus Gemcitabine plus carboplatin Number (%) of Patients Carboplatin arm (N=174)
Slovenian: Kombinirana uporaba za karcinom jajčnika Neželeni učinki 3. in 4. stopnje Karboplatin proti gemcitabinu s karboplatinom Število (%) bolnikov Veja s karboplatinom (N=174)
English: • very common: affects more than 1 user in 10
Slovenian: • zelo pogosti: pri več kot 1 od 10 bolnikov
English: For all indications, the patient must be monitored before each dose for platelet and granulocyte counts.
Slovenian: Pri vseh indikacijah je pred vsakim odmerkom potreben nadzor bolnika glede koncentracije trombocitov in granulocitov.
English: This dilution yields a gemcitabine concentration of 38 mg/ml, which includes accounting for the displacement volume of the lyophilised powder.
Slovenian: Ta razredčitev daje koncentracijo gemcitabina 38 mg/ml, kar vključuje upoštevanje nadomestitve volumna liofiliziranega praška.
English: If you are pregnant, or thinking about becoming pregnant, tell your doctor.
Slovenian: Obvestite svojega zdravnika, če ste noseči ali nameravate zanositi.
English: Sweating
Slovenian: Znojenje
English: Shake to dissolve.
Slovenian: Raztopite s pretresanjem.
English: Eli Lilly Holdings Linited, Kingsclere Road, Basingstoke,
Slovenian: Eli Lilly Holdings Limited Kingsclere Road, Basingstoke,
English: Promising data in advanced bladder cancer and the need for other treatments for superficial bladder cancer led to the study of gemcitabine by intravesical administration in superficial bladder cancer but although the CHMP acknowledged that gemcitabine has shown activity in non-muscle invasive bladder cancer in intermediate and high risk patients, no actual data from Phase III trials has been submitted.
Slovenian: Obetajoči podatki glede napredovalega raka sečnega mehurja in potreba po drugih zdravljenjih površinskega raka sečnega mehurja so privedli do študije gemcitabina z intravezikalnim dajanjem pri površinskemu raku sečnega mehurja, vendar imetnik dovoljenja za promet z zdravilom ni predložil dejanskih podatkov iz preskušanj III. faze, čeprav je CHMP potrdil, da je gemcitabin aktiven pri nemišičnem invazivnem raku sečnega mehurja bolnikov s srednje visokim in visokim tveganjem.
English: In a randomised phase III study of 126 patients with advanced or metastatic pancreatic cancer, gemcitabine showed a statistically significant higher clinical benefit response rate than 5-fluorouracil (23.8% and 4.8% respectively, p=0.0022).
Slovenian: V randomizirani študiji faze III s 126 bolniki z napredovalim ali metastatskim karcinomom trebušne slinavke, je gemcitabin pokazal značilno višjo stopnjo odziva klinične koristi kot 5-fluorouracil (23,8 % in oziroma 4,8 %, p=0,0022).
English: Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first-line therapy.
Slovenian: Gemcitabin je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim epitelijskim karcinomom jajčnika, v kombinaciji s karboplatinom, pri bolnicah z relapsom bolezni po vsaj 6-mesečnem obdobju brez relapsa, po zdravljenju prvega izbora s osnovi platino.
English: Grade 3 and 4 Adverse Events MVAC versus Gemcitabine plus cisplatin
Slovenian: Neželeni učinki 3. in 4. stopnje MVAC proti gemcitabinu s cisplatinom
English: Renal and urinary disorders Renal failure (see section 4.4) Haemolytic uraemic syndrome (see section 4.4)
Slovenian: Ledvično popuščanje (glejte poglavje 4.4) Hemolitično uremični sindrom (glejte poglavje 4.4)
English: Omit dose * *Treatment omitted will not be re-instated within a cycle before the absolute granulocyte count reaches at least 500 (x106/l) and the platelet count reaches 50,000 (x106/l).
Slovenian: Izpuščen odmerek* *Zdravljenje med ciklusom ne bo ponovno uvedeno, dokler ne bo absolutna koncentracija granulocitov dosegla vsaj 500 (x10
English: Dose modification due to haematological toxicity
Slovenian: Sprememba odmerka zaradi hematološke toksičnosti Uvedba ciklusa
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains gemcitabine hydrochloride equivalent to 200 mg gemcitabine.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje gemcitabinijev klorid, kar ustreza 200 mg gemcitabina.
English: Hepatobiliary disorders Serious hepatotoxicity, including liver failure and death
Slovenian: Bolezni jeter, žolčnika in žolčevodov Resna hepatotoksičnost, vključno z jetrnim popuščanjem in smrtjo
English: The normal safety precautions for cytostatic agents must be observed when preparing and disposing of the infusion solution.
Slovenian: Pri pripravi in odstranjevanju raztopine za infundiranje moramo upoštevati običajne varnostne ukrepe za citostatike.
English: Very Rare • Anaphylactoid reaction
Slovenian: Zelo redko • Anafilaktoidna reakcija
English: Lilly France S.A.S., rue du Colonel Lilly, F-67640, Fegersheim, France This leaflet was last approved in
Slovenian: Izdelovalec: Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, Francija Navodilo je bilo odobreno
English: Pulmonary effects, sometimes severe (such as pulmonary oedema, interstitial pneumonitis or adult respiratory distress syndrome (ARDS)) have been reported in association with gemcitabine therapy.
Slovenian: V povezavi s terapijo z gemcitabinom so poročali o učinkih na pljuča, včasih hudih (kot so pljučni edem, intersticijski pnevmonitis ali sindrom dihalne stiske pri odraslih (ARDS - Adult Respiratory Distress Syndrome)).
English: Disposal Any unused product should be disposed of in accordance with local requirements.
Slovenian: Odstranjevanje Neuporabljeno zdravilo zavrzite v skladu z lokalnimi predpisi.
English: If there is lasting irritation, a doctor should be consulted.
Slovenian: Če draženje še traja, se posvetujte z zdravnikom.
English: For the indication in bladder cancer, the MAH provided data from two Phase 2 studies and from a pivotal Phase 3, showing that gemcitabine chemotherapy is active, tolerable, displays manageable toxicity and superiority to MVAC (methotrexate, vinblastine, adriamycin and cisplatin) chemotherapy in the treatment of patients with advanced or metastatic transitional cell carcinoma of the urothelium.
Slovenian: faze in iz ključne študije III. faze, ter tako pokazal, da je kemoterapija z gemcitabinom aktivna, jo bolniki lahko prenašajo, kaže obvladljivo toksičnost ter učinkuje bolje kot kemoterapija z MVAC (metotreksat, vinblastin, adriamicin in cisplantin) pri zdravljenju bolnikov z napredovalim ali metastatskim karcinomom prehodnih celic urotelija.
English: Breast-feeding must be discontinued during gemcitabine therapy.
Slovenian: Med terapijo z gemcitabinom mora biti dojenje prekinjeno.
English: Eli Lilly Netherlands BV Grootslag 1-5
Slovenian: Nizozemska Eli Lilly Netherlands BV Grootslag 1-5
English: Intravenous gemcitabine has become widely accepted as the standard of chemotherapy care for advanced pancreatic cancer but has yielded disappointing results as combination treatment in patients with locally advanced (nonresectable) or metastatic pancreatic cancer and the MAH considered that gemcitabine monotherapy remains the standard of chemotherapy care for advanced/metastatic, nonresectable pancreatic adenocarcinoma.
Slovenian: Intravenska uporaba gemcitabina je postala široko sprejeta kot standard kemoterapijske nege bolnikov z napredovalim rakom trebušne slinavke, vendar so rezultati take uporabe pri kombinacijskemu zdravljenju bolnikov z lokalno napredovalim (ki ga ni mogoče odstraniti kirurško) ali metastatskim rakom trebušne slinavke razočarali, tako da je imetnik dovoljenja za promet z zdravilom upošteval, da bo ostala monoterapija z gemcitabinom standard za kemoterapijsko nego bolnikov z napredovalim/metastatskim adenokarcinomom trebušne slinavke, ki ga ni mogoče odstraniti kirurško.
English: Gemcitabine and carboplatin combination therapy When given in combination with carboplatin the pharmacokinetics of gemcitabine were not altered
Slovenian: Kombinirana terapija z gemcitabinom in karboplatinom Farmakokinetika gemcitabina se ni spremenila, kadar so ga dali sočasno s karboplatinom.
English: The CHMP required the MAH to reflect the target population (patients with advanced/metastatic bladder cancer) and the combination treatment with cisplatin in the harmonized indication.
Slovenian: CHMP je imetniku dovoljenja za promet z zdravilom naložil, naj usklajena indikacija odraža ciljno populacijo (bolniki z napredovalim/metastatskim rakom sečnega mehurja) in kombinacijsko zdravljenje s cisplatinom.
English: To reconstitute, add 5 ml of sterile sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, to the 200 mg vial or 25 ml sterile sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, to the 1000 mg vial.
Slovenian: Za rekonstitucijo dodajte 5 ml natrijevega klorida 9 mg/ml (0,9 %) sterilne raztopine za injiciranje, brez konzervansa v 200 mg vialo ali 25 ml natrijevega klorida 9 mg/ml (0,9 %) sterilne raztopine za injiciranje, brez konzervansa v 1.000 mg vialo.
English: HOW TO STORE GEMZAR
Slovenian: KAKO UPORABLJATI ZDRAVILO GEMZAR
English: Lilly France S.A.S 2 Rue du Colonel Lilly 6740 Fegersheim France
Slovenian: Romunija Lilly France S.A.S 2 Rue du Colonel Lilly 6740 Fegersheim
English: • very rare: affects less than 1 user in 10,000
Slovenian: • zelo redki: pri manj kot 1 od 10.000 bolnikov,
English: The CHMP assessed the SPC wording proposed by the MAH and the submitted rationales for the proposal.
Slovenian: CHMP je ocenil besedilo povzetka glavnih značilnosti zdravila, ki ga je predlagal imetnik dovoljenja za promet z zdravilom, in predložene razloge za predlog.
English: Eli Lilly Nederland BV Grootslag 1-5
Slovenian: Nizozemska Eli Lilly Nederland BV Grootslag 1-5
English: In another randomised phase III study of 135 patients with stage IIIB or IV NSCLC, a combination of gemcitabine and cisplatin showed a statistically significant higher response rate than a combination of cisplatin and etoposide (40.6% and 21.2%, respectively, p=0.025).
Slovenian: V drugi randomizirani študiji faze III s 135 bolniki s stopnjo IIIB ali IV nedrobnoceličnega karcinoma pljuč je kombinacija gemcitabina in cisplatina pokazala statistično značilno višjo stopnjo odziva kot kombinacija cisplatina in etopozida (40,6 % in oziroma 21,2 %, p=0,025).
English: Unopened vial: Store below 30°C.
Slovenian: Neodprte viale: Shranjujte pri temperaturi do 30 °C.
English: Gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy.
Slovenian: Gemcitabin je v kombinaciji s paklitakselom indiciran za zdravljenje bolnikov z neresektabilnim, lokalno ponovljenim ali metastatskim karcinomom dojke, pri katerih je prišlo do relapsa bolezni po dopolnilni/novi dopolnilni kemoterapiji.
English: Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally]
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec <[Glejte Dodatek I - Izpolni država članica]>
English: • common: affects 1 to 10 users in 100
Slovenian: • pogosti: pri 1 do 10 od 100 bolnikov
English: What Gemzar contains
Slovenian: Kaj vsebuje zdravilo Gemzar
English: SPECIAL STORAGE CONDITIONS Unopened vial: Store below 30°C Read the leaflet for the shelf life of the reconstituted product
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Neodprta viala: Shranjujte pri temperaturi do 30 °C.
English: Gemcitabine in combination with carboplatin is recommended using gemcitabine 1000 mg/m2 administered on Days 1 and 8 of each 21-day cycle as a 30-minute intravenous infusion.
Slovenian: Priporočamo gemcitabin v kombinaciji s karboplatinom, z uporabo 1.000 mg/m površine telesa gemcitabina 1. in 8. dan vsakega 21-dnevnega ciklusa, kot 30-minutna intravenska infuzija.
English: In a randomised phase III study of 529 patients with inoperable, locally recurrent or metastatic breast cancer with relapse after adjuvant/neoadjuvant chemotherapy, gemcitabine in combination with paclitaxel showed a statistically significant prolongation of time to documented disease progression from 3.98 to 6.14 months (log-rank p=0.0002) in patients treated with gemcitabine/paclitaxel compared to patients treated with paclitaxel.
Slovenian: V randomizirani študiji faze III s 529 bolniki z neoperabilnim, lokalno ponavljajočim ali metastatskim karcinomom dojke z relapsom po dopolnilni/novi dopolnilni kemoterapiji je gemcitabin v kombinaciji s paklitakselom pri bolnikih zdravljenih s gemcitabin/paklitaksel v primerjavi z bolniki, zdravljenimi s paklitakselom pokazal statistično značilno podaljšanje časa do dokumentiranega napredovanja bolezni od 3,98 do 6,14 mesecev (logaritemska stopnja p=0,0002).
English: The MAH concluded that the studies demonstrated that gemcitabine plus carboplatin is superior to carboplatin in terms of time to disease progression (TtDP) and response rate in patients with platinumsensitive recurrent ovarian cancer.
Slovenian: Imetnik dovoljenja za promet z zdravilom je zaključil, da so v študijah dokazali boljši učinek za gemcitabin in karboplatin kot karboplatin v pogledu časa do napredovanja bolezni (TtDP) in mere odziva pri ponovnem pojavu na platino občutljivega raka jajčnikov.
English: Further dilution by a healthcare provider may be done.
Slovenian: Zdravstveni delavec lahko zdravilo še nadalje redči.
English: Belgium ELI LILLY Benelux s.a. Rue De L'Etuve 52
Slovenian: ELI LILLY Benelux s.a. Rue De L'Etuve 52 B-1000 Brussels Belgija
English: The indication in non-small cell lung cancer is based on data from Phase II and Phase III trials and indicated that gemcitabine has been shown to be active in the treatment of non-small cell lung cancer (NSCLC) and that in addition to gemcitabine single-agent activity, a preponderance of data supports the activity and safety of its combination with cisplatin in the treatment of NSCLC, irrespective of the different doses and schedules.
Slovenian: in III. faze in kaže, da so dokazali aktivnost gemcitabina pri zdravljenju nedrobnoceličnega pljučnega raka (NSCLC), poleg aktivnosti samostojnega gemcitabina pa obstaja veliko število podatkov, ki podpirajo aktivnost in varnost kombinacije gemcitabina in cisplatina pri zdravljenju NSCLC, ne glede na različne odmerke in urnike odmerjanja.
English: Respiratory, thoracic and mediastinal disorders Pulmonary oedema
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Pljučni edem
English: Dosage reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient.
Slovenian: Odmerek lahko z vsakim ciklusom ali med ciklusom znižamo glede na stopnjo toksičnosti, izraženo pri bolniku.
English: In a randomised phase III study of 522 patients with inoperable, locally advanced or metastatic NSCLC, gemcitabine in combination with cisplatin showed a statistically significant higher response rate than cisplatin alone (31.0% and 12.0%, respectively, p<0.0001).
Slovenian: V randimizirani študiji faze III s 522 bolnikov z neoperabilnim, lokalno napredovalim ali metastatskim nedrobnoceličnim karcinomom pljuč, je gemcitabin s cisplatinom pokazal statistično značilno višjo stopnjo odziva kot sam cisplatin (31,0 % in oziroma 12,0 %, p<0,0001).
English: Dose modification of gemcitabine within a cycle for ovarian cancer, given in combination with carboplatin Absolute granulocyte count (x 106/l)
Slovenian: Sprememba odmerka gemcitabina med ciklusom pri zdravljenju karcinoma jajčnika, dan v kombinaciji s karboplatinom Absolutna koncentracija granulocitov (x 106/l)
English: The volume of distribution of the central compartment was 12.4 l/m2 for women and 17.5 l/m2 for men (inter-individual variability was 91.9%).
Slovenian: Porazdelitev Volumen porazdelitve osrednjega dela je bil 12,4 l/m površine telesa za ženske in 17,5 l/m površine telesa za moške.
English: “Gemcitabine is indicated in locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence free interval of at least 6 months after-platinum based, first-line therapy”
Slovenian: „Gemcitabin je indiciran za lokalno napredovali ali metastatski karcinom jajčnikov v kombinaciji s karboplatinom pri bolnicah s ponovitvijo bolezni po obdobju brez bolezni, ki je trajalo vsaj šest mesecev po zdravljenju prve izbire, ki je temeljilo na platini“.
English: One vial contains gemcitabine hydrochloride equivalent to 1000 mg gemcitabine.
Slovenian: Ena viala vsebuje gemcitabinijevega klorida, kar ustreza 1.000 mg gemcitabina.
English: - the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee, the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Gemzar.
Slovenian: - so bili povzetki glavnih značilnosti zdravila, označevanje in navodila za uporabo, ki so jih predlagali imetniki dovoljenja za promet z zdravilom, ovrednoteni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora,
English: • non-small cell lung cancer (NSCLC), alone or together with cisplatin
Slovenian: • nedrobnocelični rak pljuč, samostojno ali s cisplatinom
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Slovenian: IMETNIK DOVOLJENJA ZA PROMET <[Glejte Dodatek I - Izpolni država članica]>
English: • rare: affects 1 to 10 users in 10,000
Slovenian: • redki: pri 1 do 10 od 10.000 bolnikov
English: consecutive weeks with therapeutic thoracic radiation to patients with non-small cell lung cancer, significant toxicity in the form of severe, and potentially life threatening mucositis, especially oesophagitis, and pneumonitis was observed, particularly in patients receiving large volumes of radiotherapy [median treatment volumes 4,795 cm3].
Slovenian: V enem preskušanju, kjer so dajali gemcitabin v odmerku 1.000 mg/m površine telesa do 6 zaporednih tednov sočasno s terapevtskim obsevanjem prsnega koša bolnikom z nedrobnoceličnim karcinomom pljuč, so opazili značilno toksičnost v obliki hudega in potencialno življenje ogrožujočega vnetja sluznic, zlasti ezofagitisa in pnevmonitisa, posebno pri bolnikih, ki so prejemali velike prostornine radioterapije [srednje prostornine zdravljenja 4.795 cm 3].
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally]
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM <[Izpolni država članica]>
English: Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: Pred dajanjem moramo parenteralna zdravila pregledati za prisotnost trdnih delcev in razbarvanje.
English: Reconstitute 200 mg vials with 5 ml of 9 mg/ml (0.9 %) sterile sodium chloride solution for injection, without preservative, or 25 ml sterile sodium chloride solution for injection, without preservative to the 1000 mg vial.
Slovenian: Rekonstituirajte 200 mg vialo z 5 ml natrijevega klorida 9 mg/ml (0,9 %) sterilne raztopine za injiciranje, brez konzervansa ali 25 ml natrijevega klorida 9 mg/ml (0,9 %) sterilne raztopine za injiciranje, brez konzervansa v 1.000 mg vialo.
English: Patients should have an absolute granulocyte count of at least 1,500 (x 106/l) prior to initiation of gemcitabine + paclitaxel combination.
Slovenian: Bolniki morajo imeti pred uvedbo kombinacije gemcitabin + paklitaksel absolutno koncentracijo granulocitov vsaj 1.500 (x 10
English: Each 200 mg vial contains 3.5 mg (<1 mmol) sodium.
Slovenian: Ena 200 mg viala vsebuje 3,5 mg (< 1 mmol) natrija.
English: Yellow fever and other live attenuated vaccines are not recommended due to the risk of systemic, possibly fatal, disease, particularly in immunosuppressed patients.
Slovenian: Zaradi tveganja za sistemsko, lahko tudi smrtno bolezen, zlasti pri bolnikih z oslabljenim imunskim sistemom, ne priporočamo uporabe cepiv za rumeno mrzlico in drugih živih oslabljenih cepiv.
English: “Gemcitabine, in combination with cisplatin is indicated as first line treatment of patients with locally advanced or metastatic non small cell lung cancer.
Slovenian: „Gemcitabin je v kombinaciji s cisplatinom indiciran kot zdravilo v prvi vrsti za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom.
English: • Myalgia
Slovenian: • Mialgija
English: Reconstituted solution:
Slovenian: Rekonstituirana raztopina:
English: Use aseptic techniques during the reconstitution and any further dilution of gemcitabine for intravenous infusion administration.
Slovenian: Med rekonstitucijo in kakršnokoli nadaljno razredčitvijo gemcitabina za dajanje intravenske infuzije uporabljajte aseptične metode.
English: Ovarian cancer
Slovenian: Karcinom jajčnika
English: Dosage reduction with each cycle or within a cycle may be applied basedupon the grade of toxicity experienced by the patient.
Slovenian: Odmerek lahko z vsakim ciklusom ali med ciklusom znižamo glede na stopnjo toksičnosti, izražene pri bolniku.
English: Mean apparent clearance: 2.5 l/hr/m2 (range 1-4 l/hr/m2).
Slovenian: Povprečni navidezni očistek: 2,5 l/h/m površine telesa (razpon 1-4 l/h/m površine telesa).
English: Dose modification of gemcitabine within a cycle for bladder cancer, NSCLC and pancreatic cancer, given in monotherapy or in combination with cisplatin Absolute granulocyte count (x 10
Slovenian: Sprememba odmerka gemcitabina med ciklusom pri zdravljenju karcinoma sečnega mehurja, nedrobnoceličnega karcinoma pljuč in karcinoma trebušne slinavke, danega kot monoterapija ali v kombinaciji s cisplatinom Absolutna koncentracija granulocitov (x 106/l)
English: Constipation
Slovenian: Mrazenje