natgillin/translations-raw huggingface dataset:
In animal tumour models, antitumoural activity of gemcitabine is schedule-dependent. 
V živalskih modelih tumorjev je protitumorska aktivnost gemcitabina odvisna od sheme zdravljenja.
The CHMP was of the opinion that the MAH proposal was acceptable, but considered that interactions and conditions relevant for all cytotoxics are expected for gemcitabine and that adequate warning should therefore be provided in section 4.4 and 4.5. 
CHMP je menil, da je bil predlog imetnika dovoljenja za promet z zdravilom sprejemljiv, vendar je menil, da se za gemcitabin pričakujejo medsebojna delovanja in pogoji, ki so pomembni za vse citotoksike, in da je treba poglavji 4.4 in 4.5 opremiti s primernimi opozorili.
Type I flint glass vials, stoppered with a grey bromobutyl rubber stopper and sealed with an aluminium seal, combined with a polypropylene cap. 
Viale iz kristalnega stekla tipa I, zaprte s sivimi brombutilnimi gumijastimi zaporkami in zapečatene z aluminijastim obročkom, kombiniranim s polipropilenskim pokrovčkom.
Via Gramsci 731/733 - 50019 Sesto Fiorentino, Florence Italy 
ELI LILLY ITALIA S.P.A.. Via Gramsci 731/733 - 50019 Sesto Fiorentino, Florence Italija
In general, the CHMP considered the proposed wording to be adequate, but implemented a number of revisions, including sections on impaired bone-marrow function, combination with carboplatin and cisplatin, live attenuated vaccines and Pharmacovigilance reports on cardiovascular events and viral hepatitis reactivation. 
CHMP je v splošnem menil, da je predloženo besedilo primerno, vendar je vnesel številne spremembe, vključno s podpoglavji o okvarjeni funkciji kostnega mozga, kombinaciji s karboplatinom in cisplatinom, živimi cepivi in poročili farmakovigilance o kardiovaskularnih dogodkih in ponovni aktivaciji virusnega hepatitisa.
This should be repeated once weekly for 3 weeks, followed by a 1-week rest period. 
To ponavljamo enkrat tedensko v obdobju do 3 tednov, ki mu sledi 1-tedenska prekinitev.
As with other cytotoxic treatments, the risk of cumulative bone-marrow suppression must be considered when gemcitabine treatment is given together with other chemotherapy 
Kot pri drugih citotoksičnih zdravljenjih, je potrebno upoštevati tveganje za kumulativno zaviranje kostnega mozga, kadar zdravljenje z gemcitabinon dajemo skupaj z drugo kemoterapijo.
Very rare 
Zelo redko
Gemcitabine has been well tolerated in patients over the age of 65. 
Bolniki, starejši od 65 let so dobro prenašali gemcitabin.
Nervous system disorders Cerebrovascular accident 
Bolezni živčevja Cerebrovaskularni dogodek
Based on the responses, the CHMP revised the text in section 4.2. 
CHMP je besedilo v poglavju 4.2 pregledal na osnovi teh odgovorov.
dFdCTP kinetics 
Farmakokinetika dFdCTP
Due to the risk of cardiac and/or vascular disorders with gemcitabine, particular caution must be exercised with patients presenting a history of cardiovascular events. 
Zaradi tveganja za srčne ali žilne motnje ali oboje z gemcitabinom, je potrebno izvajati posebno pozornost pri bolnikih, ki so imeli kardiovaskularne dogodke v anamnezi.
If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at room temperature, unless reconstitution(and further dilution, if applicable) has taken place in controlled and validated aseptic conditions. 
Če ga ne uporabimo takoj, sta čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika in naj običajno ne presegata 24 ur pri sobni temperaturi, razen če je bila rekonstitucija (in nadaljnja razredčitev, če je potrebno) izvedena v nadzorovanih in validiranih aseptičnih pogojih.
The cytotoxic effect of gemcitabine is due to inhibition of DNA synthesis by two mechanisms of action by dFdCDP and dFdCTP. 
Citotoksični učinek gemcitabina je posledica zaviranja sinteze DNK z dvema mehanizmoma delovanja dFdCDP in dFdCTP.
If you have further questions on the use of this product ask your doctor or pharmacist. 
Če imate dodatna vprašanja o uporabi vašega zdravila, se posvetujte z zdravnikom ali s farmacevtom.
Differences in response rate of 47.2% in the GCb arm versus 30.9% in the Cb arm (p=0.0016) and median survival 18 months (GCb) versus 17.3 (Cb) (p=0.73) favoured the GCb arm. 
Razlike v stopnji odziva v veji GCb 47,2 % proti veji Cb 30,9 % (p=0,0016) ter povprečnega preživetja 18 mesecev (GCb) proti 17,3 (Cb) (p=0,73) so bile v korist veje GCb.
• Platelets < 25,000 x 106/l 
• trombociti < 25.000 x 10
• Severe skin reactions, including desquamation and bullous skin eruptions 
• Hude kožne reakcije, vključno z luščenjem in buloznimi kožnimi vzbrstmi
The CHMP therefore adopted the remaining five indications for Gemzar, as worded in the revised SPC. 
CHMP je zato sprejel ostalih pet indikacij za zdravilo Gemzar, kot so bile ubesedene v popravljenem povzetku glavnih značilnosti zdravila.
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution Read the package leaflet before use. 
POSTOPEK IN POT UPORABE ZDRAVILA Za intravensko uporabo po rekonstituciji Pred uporabo preberite priloženo navodilo.
Second, dFdCTP competes with dCTP for incorporation into DNA (self-potentiation). 
Nato dFdCTP tekmuje z dCTP za vgrajevanje v DNK (samo-ojačitev).
Hungary Eli Lilly Nederland BV PO Box 379 
Madžarska Eli Lilly Nederland BV PO Box 379
The frequency and severity of the adverse reactions are affected by the dose, infusion rate and intervals between doses (see section 4.4). 
Na pogostnost in hudost neželenih učinkov vplivajo odmerek, hitrost infuzije in intervali med odmerki (glejte poglavje 4.4).
Before each infusion you will have samples of your blood taken to evaluate if you have enough blood cells to receive Gemzar. 
Pred vsako infuzijo vam bodo vzeli vzorce vaše krvi, da preverijo, če imate dovolj krvnih celih za prejem zdravila Gemzar.
Like all medicines, Gemzar can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi zdravilo Gemzar neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Intracellular metabolism of gemcitabine produces the gemcitabine mono, di and triphosphates (dFdCMP, dFdCDP and dFdCTP) of which dFdCDP and dFdCTP are considered active. 
Znotrajcelična presnova gemcitabina tvori gemcitabin mono, di in trifosfate (dFdCMP, dFdCDP in dFdCTP), od katerih dFdCDP in dFdCTP veljata za aktivna.
Combination use 
Kombinirana uporaba
The most commonly reported adverse drug reactions associated with Gemzar treatment include: nausea with or without vomiting, raised liver transaminases (AST/ALT) and alkaline phosphatase, reported in approximately 60% of patients; proteinuria and haematuria reported in approximately 50% patients; dyspnoea reported in 10-40% of patients (highest incidence in lung cancer patients); allergic skin rashes occur in approximately 25% of patients and are associated with itching in 10% of patients. 
Najpogosteje poročani neželeni učinki povezani z zdravilom Gemzar vključujejo: navzeo z ali brez bruhanja, zvišane jetrne transaminaze (AST/ALT) in alkalna fosfataza, o katerih so poročali pri približno 60 % bolnikov; proteinurija in hematurija, o katerih so poročali pri približno 50 % bolnikov; dispneja, o kateri so poročali pri 10-40 % bolnikov (z najvišjo incidenco pri bolnikih s karcinomom pljuč); alergijski izpuščaji so se pojavili pri približno 25 % bolnikov, pri 10 % bolnikov so ti izpuščaji srbeči.
Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C. 
Dokazali so kemijsko in fizikalno stabilnost med uporabo za 24 ur pri 30 °C.
Hampshire RG24 9NL United Kingdom 
Hampshire RG24 9NL Velika Britanija
The use of Gemzar should be avoided during pregnancy. 
Med nosečnostjo se moramo izogibati uporabi zdravila Gemzar.
In fertility studies, gemcitabine caused reversible hypospermatogenesis in male mice. 
V študijah plodnosti je gemcitabin povzročil povratno hipospermatogenezo pri mišjih samcih.
After gemcitabine, carboplatin will be given on Day 1 consistent with a target Area under curve (AUC) of 4.0 mg/ml·min. 
Po gemcitabinu na 1. dan damo karboplatin, da dosežemo ciljno AUC (Area Under the Curve) 4,0 mg/ml x minuto.
Adult Respiratory Distress Syndrome (severe lung inflammation causing respiratory failure) Radiation recall-(a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy. 
Sindrom dihalne stiske pri odraslih (hudo vnetje pljuč, ki povzroči pljučno popuščanje) Povratna radiacija (kožni izpuščaj v obliki hude sončne opekline), ki se lahko pojavi na koži, ki je bila predhodno izpostavljena radioterapiji.
Other sections of the SPC: While the full harmonisation of the quality dossier was not part of the scope of the referral, the sections of the SPC (in particular sections 2 and 6) and the corresponding Package Leaflet sections relating to Quality were assessed and harmonised. 
Druga poglavja povzetka glavnih značilnosti zdravila: Čeprav popolna uskladitev dosjeja o kakovosti ni bila del napotitvenega postopka, so bila ovrednotena in usklajena poglavja povzetka glavnih značilnosti zdravila (še posebej 2. in 6. poglavje) in ustrezna poglavja navodila za uporabo, ki se nanašajo na kakovost.
Laboratory Anaemia Neutropaenia Thrombocytopaenia Leucopaenia Non-laboratory Haemorrhage Febrile neutropaenia Infection without neutropaenia Sensory neuropathy was also more frequent in the combination arm than with single agent carboplatin 
Laboratorijski Anemija Nevtropenija Trombocitopenija Levkopenija Ne-laboratorijski Hemoragija Febrilna nevtropenija Infekcija brez nevtropenije Senzorna nevropatija je bila tudi bolj pogosta v veji kombinacije kot pri samostojnemu karboplatinu.
Peak plasma concentrations (obtained within 5 minutes of the end of the infusion) were 3.2 to 45.5 µg/ml. 
Najvišje plazemske koncentracije (dosežene v 5 minutah po koncu infuzije) so bile 3,2 in 45,5 µg/ml.
Side effects with Gemzar may include: 
Neželeni učinki pri zdravilu Gemzar lahko vključujejo:
Platelet count (x 106/l) 
Koncentracija trombocitov (x 106/l)
The usual dose of Gemzar is 1000-1250 mg for every square metre of your body's surface area. 
Običajen odmerek zdravila Gemzar je 1.000-1.250 mg na vsak kvadratni meter vaše telesne površine.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
DNA polymerase epsilon lacks the ability to eliminate gemcitabine and to repair the growing DNA strands. 
DNK polimeraza epsilon nima sposobnosti za izločanje gemcitabina in popravljanje DNK vijačnice, ki se tvori.
Inhibition of this enzyme by dFdCDP reduces the concentration of deoxynucleosides in general and, in particular, dCTP. 
Zaviranje tega encima z dFdCDP na splošno zniža koncentracijo dezoksinukleozidov in še zlasti dCTP.
Due to solubility considerations, the maximum concentration for gemcitabine upon reconstitution is 40 mg/ml. 
Glede na topnost je najvišja koncentracija gemcitabina po rekonstituciji 40 mg/ml.
The active substance is gemcitabine. 
Zdravilna učinkovina je gemcitabin.
Systemic clearance ranged from 29.2 l/hr/m2 to 92.2 /hr/m2 depending on gender and age (inter-individual variability was 52.2%). 
Izločanje Sistemski očistek je bil v razponu od 29,2 l/h/m površine telesa do 92,2 l/h/m površine telesa, odvisno od spola in starosti (variabilnost med posamezniki je bila 52,2 %).
Laboratory Anaemia Thrombocytopaenia Non-laboratory Nausea and vomiting Diarrhoea Infection Stomatitis 
Laboratorijski Anemija Trombocitopenija Ne-laboratorijski Navzea in bruhanje Diareja Vnetje Stomatitis
• Influenza-like symptoms - the most common symptoms are fever, headache, chills, myalgia, asthenia and anorexia. 
• Gripi podobni simptominajpogostejši simptomi so zvišana telesna temperatura, glavobol, mrzlica, mialgija, astenija in anoreksija.
The MAH supported its position by providing guidelines from major oncology societies and review of the literature and proposed a new wording for the single agent in NSCLC indication. 
Imetnik dovoljenja za promet z zdravilom je svoje mnenje podprl tako, da je predložil smernice največjih onkoloških zvez in pregled literature, ter predlagal novo besedilo za uporabo zdravila kot samostojnega sredstva pri indikaciji NSCLC.
Gemcitabine shows significant cytotoxic effects against a variety of cultured murine and human tumour cells. 
Gemcitabin kaže značilne citotoksične učinke proti številnim kulturam glodalskih in humanih tumorskih celic.
After reconstitution, the solution contains 38 mg/ml of gemcitabine. 
Po rekonstituciji raztopina vsebuje 38 mg/ml gemcitabina.
Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA Houten The Netherlands 
Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA Houten Nizozemska
What Gemzar is and what it is used for Before you are given Gemzar How Gemzar is given Possible side effects How to store Gemzar Further information 
Kaj je zdravilo Gemzar in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Gemzar Kako uporabljati zdravilo Gemzar Možni neželeni učinki
Because no studies have been made in patients with renal or hepatic impaired, the CHMP did not consider there to be a need for an absolute contraindication, nor did it consider radiotherapy to be an absolute contra-indication. 
Ker pri bolnikih z ledvično ali jetrno okvaro niso izvedli nobenih študij, je CHMP menil, da ni potrebe po absolutni kontraindikaciji, kar je menil tudi za zdravljenje z obsevanjem.
Bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common). 
Krvavitve iz dlesni, nosa ali ust ali imate kakršnakoli krvavitev, ki se ne ustavi, rdečkast ali rozast urin, nepričakovane modrice (ker imate morda manj krvnih ploščic kot bi morali, kar je zelo pogosto).
and or and or 
in ali ali
The patient should be monitored carefully after the administration. 
Po dajanju je potrebno bolnike skrbno nadzorovati.
Rare • Hypotension 
Redko • Hipotenzija
Gemcitabine should be discontinued at the first signs of any evidence of microangiopathic haemolytic anaemia, such as rapidly falling haemoglobin with concomitant thrombocytopaenia, elevation of serum bilirubin, serum creatinine, blood urea nitrogen, or LDH. 
Pri prvih znakih kakršnegakoli dokaza o mikroangiopatski hemolitični anemiji, kot je hiter padec hemoglobina s sočasno trombocitopenijo, zvišan serumski bilirubin, serumski kreatinin, dušik sečnine v krvi ali LDH, je treba prekiniti z gemcitabinom.
For cisplatin, carboplatin, and paclitaxel dosage adjustment in combination therapy, please refer to the corresponding Summary of Product Characteristics. 
Za prilagoditev odmerka cisplatina, karboplatina in paklitaksela, se prosimo obrnite na ustrezne Povzetke glavnih značilnosti zdravil.
Rare • Myocardial infarct 
Redko • Miokardni infarkt
As no studies were available to support the use of gemcitabine as single agent neither in first or second line, the CHMP requested the MAH to further discuss the indication of Gemzar in ovarian cancer. 
Ker ni bilo študij v podporo uporabi gemcitabina kot samostojnega sredstva prve niti druge izbire, je CHMP od imetnika dovoljenja za promet z zdravilom zahteval nadaljnjo razpravo o indikaciji zdravila Gemzar za rak jajčnikov.
Back pain 
Boleč hrbet
- If you have further questions, please ask your doctor, nurse or pharmacist. 
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
Take special care with Gemzar: 
Bodite posebno pozorni pri uporabi zdravila Gemzar:
The MAH also considered that the limited data available does not permit any dose modifications to be suggested in the SPC for patients with renal or hepatic impairment and that the precautions already adequately reflect the information available. 
Imetnik dovoljenja za promet z zdravilom je tudi menil, da omejena količina podatkov ne dovoljuje predlaganja sprememb odmerkov v povzetku glavnih značilnosti zdravila za bolnike z okvaro ledvic ali jeter in da varnostni ukrepi že primerno odražajo razpoložljive informacije.
• Elevation of liver transaminases (AST and ALT) and alkaline phosphatase 
• Zvišane jetrne transaminaze (AST in ALT) in alkalna fosfataza
For Section 4.3, the MAH proposal retained only two of the existing 8 contraindications (relating to hypersensitivity and breast feeding) and removed 6 (hepatic or renal impairment, cisplatin for patients with severe renal failure, pregnancy and lactation, combination with yellow fever, usage in children and concomitant administration of gemcitabine and radiotherapy). 
Predlog imetnika dovoljenja za promet glede poglavja 4.3 je obdržal le dve od obstoječih osmih kontraindikacij (glede preobčutljivosti in dojenja) ter umaknil ostalih šest (okvara jeter ali ledvic, cisplatin za bolnike s hudo odpovedjo ledvic, nosečnost in dojenje, uporaba pri rumeni mrzlici, uporaba pri otrocih in sočasna uporaba gemcitabina in zdravljenja z obsevanjem).
The CHMP was of the opinion that gemcitabine has shown activity as single agent in MBC but the lack of Phase III trials in this setting makes it difficult to give a specific recommendation about the precise place of gemcitabine in the treatment of advance breast cancer. 
CHMP je bil mnenja, da je gemcitabin izkazal učinkovitost kot samostojno sredstvo proti MBC, vendar pa je pomanjkanje preskusov III. faze otežilo navedbo točno določenih priporočil o natančni vlogi gemcitabina pri zdravljenju napredovalega raka dojk.
Doses as high as 5700 mg/m2 have been administered by intravenous infusion over 30-minutes every 2 weeks with clinically acceptable toxicity. 
Odmerki do 5.700 mg/m površine telesa dani z intravensko infuzijo v 30 minutah vsake 2 tedna imajo klinično sprejemljivo toksičnostjo.
This should be taken into consideration by patients on a controlled sodium diet. 
To morajo upoštevati bolniki, ki so na dieti z nadzorovanim vnosem natrija.
Pain, redness, swelling or sores in your mouth (common). 
Bolečina, rdečina, oteklina ali rane v vaših ustih (pogosto).
Denmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby Denmark 
Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby Danska
Gemzar is tolerated well during infusion and may be administered ambulant. 
Gemzar bolniki med infuzijo dobro prenašajo in ga lahko dajemo ambulantno.
Cough, rhinitis, malaise, perspiration and sleeping difficulties have also been reported. 
Poročali so tudi o kašlju, rinitisu, bolehnosti, znojenju in motnjah spanja.
The CHMP noted the pivotal study JHQJ was powered to detect differences in TtDP in overall survival and that the pivotal study for the ovarian cancer had a specific population consisting of platinum sensitive patients with a very poor prognosis and the CHMP was of the opinion that the proposed wording was in accordance with the submitted study for the marketing authorisation in this indication. 
CHMP je opazil, da je bila ključna študija JHQJ zasnovana tako, da je zaznavala razlike v TtDP za celotno preživetje in da je bila v ključno študijo za raka jajčnikov vključena posebna populacija, ki so jo sestavljale na platino občutljive bolnice z zelo slabo napovedjo poteka bolezni, tako da je bil CHMP mnenja, da je predlagano besedilo za to indikacijo skladno s predloženo študijo za dovoljenje za promet z zdravilom.
Patients receiving gemcitabine should be monitored prior to each dose for platelet, leucocyte and granulocyte counts. 
Bolnike, ki prejemajo gemcitabin je potrebno pred vsakim odmerjanjem nadzorovati glede koncentracije trombocitov, levkocitov in granulocitov.
Mean volume of distribution of central compartment: 18 l/m2 (range 11-22 l/m2). 
Povprečni volumen porazdelitve osrednjega dela: 18 l/m površine telesa (razpon 11-22 l/m površine telesa).
For instructions on reconstitution, see section 6.6 
Za navodila glede rekonstitucije glejte poglavje 6.6.
Thus, the reduced intracellular concentration of dCTP potentiates the incorporation of dFdCTP into DNA. 
Tako znižana znotrajcelična koncentracija dCTP ojača vgrajevanje dFdCTP v DNK.
Mannitol (E421), sodium acetate, hydrochloric acid and sodium hydroxide. 
Manitol (E421), natrijev acetat, klorovodikova kislina in natrijev hidroksid.
The MAH also defended the use of gemcitabine by intravesical administration, based on the proven activity in advanced bladder cancer, on the pharmacokinetic attributes of gemcitabine and on its high total body clearance. 
Imetnik dovoljenja za promet z zdravilom je zagovarjal tudi uporabo gemcitabina z intravezikalnim dajanjem, kar temelji na dokazani aktivnosti pri napredovalemu raku sečnega mehurja, na farmakokinetičnih lastnostih gemcitabina in na njegovem visokem celotnem telesnem očistku.
• Rhinitis 
• Rinitis
Prior chemotherapy should have included an anthracycline unless clinically contraindicated.” 
Predhodna kemoterapija mora vključevati antraciklin, razen če to ni klinično kontraindicirano."
Gemcitabine plus carboplatin arm (N=175) Grade 3 Grade 4 Grade 3 Grade 4 
Veja z gemcitabinom in karboplatinom (N=175) 3. stopnja 4. stopnja 3. stopnja 4. stopnja
The MAH defended the use of gemcitabine for the ovarian cancer indication based on a number of guidelines, considering that based on the demonstrated significant benefits of gemcitabine in combination with carboplatin, the acceptable toxicity profile and the tolerability of the treatment, this combination presents a favourable risk/benefit relationship in the treatment of recurrent ovarian cancer patients. 
Imetnik dovoljenja za promet z zdravilom je uporabo gemcitabina pri indikaciji raka jajčnikov zagovarjal na temelju številnih smernic ob upoštevanju tega, da zaradi dokazanih pomembnih koristi gemcitabina v kombinaciji s karboplatinom in profila toksičnosti ter sprejemljivega prenašanja zdravila, ta kombinacija predstavlja ugodno razmerje med tveganji in koristmi pri zdravljenju bolnikov s ponovitvijo raka jajčnikov.
• Stomatitis and ulceration of the mouth 
• Stomatitis in razjede v ustih
6.6 Special precautions for disposal and other handling 
6.6 Posebni varnostni ukrepi za odstranjevaje in ravnanje z zdravilom
Gemcitabine should only be prescribed by a physician qualified in the use of anti-cancer chemotherapy. 
Gemcitabin lahko predpiše samo zdravnik z izkušnjami pri uporabi kemoterapevtikov za zdravljenje karcinomov.
• Oedema/peripheral oedemaincluding facial oedema. 
• Edem/periferni edem - vključno z edemom obraza.
Gemcitabine and paclitaxel combination therapy Combination therapy did not alter the pharmacokinetics of either gemcitabine or paclitaxel. 
Kombinirana terapija z gemcitabinom in paklitakselom Kombinirana terapija ni spremenila farmakokinetike gemcitabina ali paklitaksela.
The MAH therefore considered the positive benefit-risk ratio to be established for the use of gemcitabine/cisplatin in the treatment of NSCLC. 
Imetnik dovoljenja za promet z zdravilom je zaradi tega menil, da je bilo pozitivno razmerje koristi in tveganj uporabe gemcitabina/cisplatina pri zdravljenju NSCLC dokazano.
Dose modification due to non haematological toxicity Periodic physical examination and checks of renal and hepatic function should be made to detect non haematological toxicity. 
Sprememba odmerka zaradi ne-hematološke toksičnosti Za odkritje ne-hematološke toksičnosti so potrebni redni telesni pregled in preverjanje ledvičnega in jetrnega delovanja.
Gemcitabine should be used with caution in patients with hepatic or renal insufficiency as there is insufficient information from clinical studies to allow for clear dose recommendations for these patient populations (see sections 4.4 and 5.2). 
Gemcitabin moramo uporabljati previdno pri bolnikih z jetrnim ali ledvičnim popuščanjem, ker je premalo podatkov iz kliničnih študij, ki bi omogočali jasna priporočila za odmerjanje pri teh skupinah bolnikov (glejte poglavji 4.4 in 5.2).