natgillin/translations-raw huggingface dataset:
- 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).
First, dFdCDP inhibits ribonucleotide reductase, which is uniquely responsible for catalysing the reactions that produce deoxynucleoside triphosphates (dCTP) for DNA synthesis.
Najprej dFdCDP zavira ribonukleotidno reduktazo, ki je katalizira samo reakcije, ki tvorijo dezoksinukleozidne trifosfate (dCTP) za sintezo DNK.
Skin rash- allergic skin rash, frequently itchy Hair loss
Kožni izpuščaj - alergisjki kožni izpuščaj, pogosto srbeč Izguba las
In general, for severe (Grade 3 or 4) nonhaematological toxicity, except nausea/vomiting, therapy with gemcitabine should be withheld or decreased depending on the judgement of the treating physician.
Na splošno bi moral lečeči zdravnik pri hudi (Stopnja 3 ali 4) nehematološki toksičnosti, razen pri navzei/bruhanju, glede na oceno, prekiniti ali znižati odmerek gemcitabina.
PHARMACEUTICAL FORM AND CONTENTS 1 vial, powder for solution for infusion
FARMACEVTSKA OBLIKA IN VSEBINA 1 viala, prašek za raztopino za infundiranje
Tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).
Utrujenost, občutek omedlevice, se hitro zadihate ali izgledate bledi (ker imate morda manj hemoglobina kot bi morali, kar je zelo pogosto).
• Anaemia
• Anemija
OTHER SPECIAL WARNING(S), IF NECESSARY Do not refrigerate the reconstituted solution
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Rekonstituirane raztopine ne shranjujte v hladilniku.
Each vial contains 200 or 1000 mg of gemcitabine.
Vsaka viala vsebuje 200 ali 1.000 mg gemcitabina.
The MAH agreed to delete the indication in superficial bladder cancer and the CHMP accordingly proposed the following revised wording:
Imetnik dovoljenja za promet z zdravilom se je strinjal glede izbrisa indikacije površinskega raka sečnega mehurja, CHMP pa je skladno s tem predlagal spodnje popravljeno besedilo:
Gemcitabine plus Paclitaxel arm (N=262) Grade 3 Grade 4 Grade 3 Grade 4
Veja z gemcitabinom in paklitakselom (N=262) 3. stopnja 4. stopnja 3. stopnja 4. stopnja
Prior chemotherapy should have included an anthracycline unless clinically contraindicated.
Predhodna kemoterapija mora vključevati antracikline, razen če so klinično kontraindicirani.
Heart attack (myocardial infarction) Low blood pressure
Redki neželeni učinki Srčni napad (miokardni infarkt) Nizek krvni tlak
Laboratory Anaemia Thrombocytopaenia Neutropaenia Non-laboratory Febrile neutropaenia Fatigue Diarrhoea Motor neuropathy Sensory neuropathy *Grade 4 neutropaenia lasting for more than 7 days occurred in 12.6% of patients in the combination arm and 5.0% of patients in the paclitaxel arm.
Laboratorijski Anemija Trombocitopenija Nevtropenija Ne-laboratorijski Febrilna nevtropenija Utrujenost Diareja Motorična nevtropenija 2 (0,8) Senzorna nevtropenija *Nevtropenija 4. stopnje, ki je trajala več kot 7 dni, se je pojavila pri 12,6 % bolnikov v veji s kombinacijo in pri 5,0 % bolnikov v veji z paklitakselom.
The MAH provided an updated posology taking into account the CHMP comments.
Imetnik dovoljenja za promet z zdravilom je predložil posodobljene podatke o odmerjanju, pri tem pa upošteval pripombe CHMP.
Periodically you will have samples of your blood taken to evaluate your kidney and liver function.
Redno vam bodo jemali vzorce vaše krvi, da preverijo delovanje vaših ledvic in jeter.
Gemcitabine is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.
Zaradi pomanjkanja podatkov glede varnosti in učinkovitosti, uporabe gemcitabina pri otrocih mlajših od 18 let ne priporočamo.
The CHMP reviewed the MAH responses and agreed that as a single agent, gemcitabine has a specific role in patients with a borderline performance status and elderly patients and that gemcitabine is an option between other treatments, although no specific agent has been identified to be better than others.
CHMP je pregledal odgovore imetnika dovoljenja za promet z zdravilom in se strinjal, da ima gemcitabin kot samostojno sredstvo posebno vlogo pri bolnikih z mejnim statusom učinkovitosti ter starostnih bolnikih, in da je gemcitabin eno od možnih zdravljenj, čeprav ni bilo točno določeno nobeno sredstvo, ki bi bilo boljše od drugih.
In addition, the use of gemcitabine for the treatment of recurrent ovarian cancer has been widely recognized and the MAH therefore believes that carboplatin plus gemcitabine represents a valuable option for treating patients with recurrent ovarian cancer.
Poleg tega je uporaba gemcitabina za zdravljenje ponovljenega raka jajčnikov široko priznana, tako da imetnik dovoljenja za promet z zdravilom verjame, da kombinacija karboplatina in gemcitabina predstavlja dragoceno možnost zdravljenja bolnic s ponovljenim rakom jajčnikov.
Skin scaling, ulceration or blister formation Injection site reactions
Luščenje kože, gnojenje ali tvorba mehurjev Reakcije na mestu injiciranja
Studies done subsequently have suggested that it is feasible to administer gemcitabine at lower doses with concurrent radiotherapy with predictable toxicity, such as a phase II study in non-small cell lung cancer, where thoracic radiation doses of 66 Gy were applied concomitantly with an administration with gemcitabine (600 mg/m2, four times) and cisplatin (80 mg/m2 twice) during 6 weeks.
Študije, ki so jih opravili naknadno, kažejo, da je možno dati gemcitabin v nižjih odmerkih s sočasno radioterapijo s predvidljivo toksičnostjo, kot v študiji faze II pri bolnikih z nedrobnoceličnim karcinomom pljuč, ki so v 6 tednih prejemali odmerke obsevanja prsnega koša 66 Gy sočasno z dajanjem gemcitabina (600 mg/m površine telesa, štirikrat) in cisplatina (80 mg/m površine telesa, dvakrat).
The CHMP retained the conservative age of 18 and also noted that information regarding hepatic impairment was included and therefore requested the MAH to further discuss patients with renal or hepatic impairment and whether severe impairment had significant effect on gemcitabine pharmacokinetics.
CHMP je obdržal konzervativno starost 18 let, poleg tega pa opazil, da so prisotne tudi informacije o okvarjenih jetrih, zaradi česar je od imetnika dovoljenja za promet z zdravilom zahteval nadaljnjo razpravo o bolnikih z okvaro jeter ali ledvic in odgovor na vprašanje, ali je imela huda okvara vpliv na farmakokinetiko gemcitabina.
Gemcitabine is rapidly metabolised by cytidine deaminase in the liver, kidney, blood and other tissues.
Gemcitabin se hitro presnavlja s citidinsko aminazo v jetrih, ledvicah, krvi in drugih tkivih.
Grade 3 and 4 Adverse Events Paclitaxel versus gemcitabine plus paclitaxel Number (%) of Patients Paclitaxel arm (N=259)
Neželeni učinki 3. in 4. stopnje Paklitaksel proti gemcitabinu s paklitakselom Število (%) bolnikov Veja s paklitakselom (N=259)
Finally, a number of additional minor comments, including comments to remaining sections of the SPC, were made by the CHMP and implemented directly in the SPC text.
CHMP je na koncu imel še številne majhne pripombe, ki so vključevale pripombe na ostala poglavja povzetka glavnih značilnosti zdravila in ki jih je vnesel naravnost v besedilo povzetka glavnih značilnosti zdravila.
Triphasic plasma concentration versus time curve, mean half-life of terminal phase - 65 hours (range 33-84 hr).
Na trofaznem grafu plazemskih koncentracij v odvisnosti od časa je povprečni končni razpolovni čas - 65 ur (razpon 33-84 ur).
Regarding ovarian cancer, the MAH proposed a wording for combination use in this indication, although activity is shown by gemcitabine as a single agent, and provided a clinical expert report and supplementary information to support the indication.
Glede raka jajčnikov je imetnik dovoljenja za promet z zdravilom predlagal besedilo, ki pri tej indikaciji narekuje kombinacijsko uporabo gemcitabina, čeprav je ta učinkoval tudi kot samostojno sredstvo, in je v podporo indikaciji predložil poročilo kliničnih specialistov ter dodatne informacije.
Cisplatin is given at a recommended dose of 70 mg/m2 on Day 1 following gemcitabine or day 2 of each 28-day cycle.
Cisplatin dajemo v priporočenem odmerku 70 mg/m površine telesa 1. dan po gemcitabinu ali 2. dan vsakega 28-dnevnega ciklusa.
Gemcitabine can suppress bone marrow function as manifested by leucopaenia, thrombocytopaenia and anaemia.
Gemcitabin lahko zavre delovanje kostnega mozga, kar se izrazi kot levkopenija, trombocitopenija in anemija.
The other ingredients are mannitol (E421), sodium acetate, hydrochloric acid and sodium hydroxide.
Pomožni snovi so manitol (E421), natrijev acetat, klorovodikova kislina in natrijev hidroksid.
Radiation injury has been reported on targeted tissues (e.g. oesophagitis, colitis, and pneumonitis) in association with both concurrent and non-concurrent use of gemcitabine.
O obsevalnih poškodbah so poročali na ciljnih tkivih (npr. ezofagitis, kolitis in pnevmonitis) v povezavi s sočasno in ne-sočasno uporabo gemcitabina.
Overall, the MAH therefore considered gemcitabine plus paclitaxel combination chemotherapy to be an effective regimen in patients with metastatic breast cancer, with an expected and manageable toxicity and a favourable risk-benefit profile.
Imetnik dovoljenja za promet z zdravilom je tako v splošnem menil, da je kombinacijska kemoterapija z gemcitabinom in paklitakselom učinkovita terapija za bolnike z metastatskim rakom dojk, ki ima pričakovano in obvladljivo toksičnost in ugoden profil tveganj in koristnih učinkov.
Dose-limiting adverse reactions are reductions in thrombocyte, leucocyte and granulocyte counts (see section 4.2).
Neželeni učinki, zaradi katerih je treba odmerek omejiti, so znižanja koncentracij trombocitov, levkocitov in granulocitov (glejte poglavje 4.2).
Gemcitabine should be used with caution in patients with hepatic insufficiency or with impaired renal function as there is insufficient information from clinical studies to allow clear dose recommendation for this patient population (see section 4.2).
Gemcitabin moramo uporabljati previdno pri bolnikih z jetrnim popuščanjem ali z okvarjenim delovanjem ledvic, ker je premalo podatkov iz kliničnih študij, ki bi omogočali jasna priporočila za odmerjanje pri teh skupinah bolnikov (glejte poglavje 4.2).
Instructions for reconstitution (and further dilution, if performed) The only approved diluent for reconstitution of gemcitabine sterile powder is sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative).
Navodila za rekonstitucijo (in nadaljnjo razredčitev, če je opravljena) Edini odobreni vehikel za rekonstitucijo sterilnega praška gemcitabina je natrijev klorid 9 mg/ml (0,9 %) raztopina za injiciranje (brez konzervansa).
Gemzar 1000 mg contains:
Gemzar 1.000 mg vsebuje:
In a randomised phase III study, 356 patients with advanced epithelial ovarian carcinoma who had relapsed at least 6 months after completing platinum based therapy were randomised to therapy with gemcitabine and carboplatin (GCb), or carboplatin (Cb).
Karcinom jajčnika V randomizirani študiji faze III s 365 bolniki z napredovalim epitelijskim karcinomom jajčnika, ki so imeli relaps najmanj 6 mesecev po zaključeni terapiji na osnovi platine, so bili randomizirani na terapijo z gemcitabinom in karboplatinom (GCb) ali karboplatinom (Cb).
Do not use after the expiry date (EXP) which is stated on the carton.
Zdravila Gemzar ne smete uporabljati po datumu izteka roka uporabnosti (Uporabno do:), ki je naveden na škatli.
Bone-marrow suppression is usually mild to moderate and mostly affects the granulocyte count (see section 4.2)
Zaviranje kostnega mozga je običajno blago do zmerno in prizadane zlasti koncentracijo granulocitov (glejte poglavje 4.2)
For Section 4.4, the MAH addressed impaired renal and hepatic function, paediatric recommendations and concomitant administration of gemcitabine and radiotherapy.
Za poglavje 4.4 je imetnik dovoljenja za promet z zdravilom obravnaval okvaro jetrne in ledvične funkcije, priporočila za pediatrične bolnike in sočasno uporabo gemcitabina ter zdravljenja z obsevanjem.
• ovarian cancer, together with carboplatin.
• rak jajčnika, skupaj s karboplatinom
Gemzar (gemcitabine) is a pyrimidine antagonist (an antimetabolite) that is metabolised intracellularly to active diphosphate and triphosphate nucleosides which inhibit DNA synthesis.
Zdravilo Gemzar (gemcitabin) je antagonist pirimidina (antimetabolit), ki se metabolizira znotraj celic v aktivni difosfat in trifosfat nukleozid, ki zavirata sintezo DNK.
The MAH agreed that platinum-based combination therapies are the standard of care but defended the use of gemcitabine monotherapy in the treatment of elderly patients and patients with a Performance Status of 2, as these groups are at higher risk for chemotherapy-related morbidities or in cases where platinum-based combinations cannot be tolerated.
Imetnik dovoljenja za promet z zdravilom se je strinjal, da so kombinacijske terapije na osnovi platine standardna nega, vendar je zagovarjal uporabo monoterapije z gemcitabinom pri zdravljenju starostnih bolnikov in bolnikov s statusom učinkovitosti 2, ker sta ti skupini bolj izpostavljeni tveganju s kemoterapijo povezane obolevnosti, ali v primerih, ko bolniki kombinacij na osnovi platine ne morejo prenašati.
Adult respiratory distress syndrome (see section 4.4)
Sindrom dihalne stiske pri odraslem (glejte poglavje 4.4)
The total volume after reconstitution is 5.26 ml (200 mg vial) or 26.3 ml (1000 mg vial) respectively.
Celotni volumen po rekonstituciji je 5,26 ml (200 mg viala) ali 26,3 ml (1.000 mg viala).
The CHMP reviewed the information regarding the use of Gemcitabine in ovarian cancer and was of the opinion that the combination gemcitabine/carboplatin is an option in second line therapy in patients with sensitive platinum disease and an alternative in patients with previous paclitaxel/carboplatin toxicity (Therefore the CHMP retained the indication in ovarian cancer in the harmonised SPC, with the wording:
CHMP je pregledal informacije o uporabi gemcitabina pri raku jajčnikov in je bil mnenja, da je kombinacija gemcitabina/karboplatina možnost za zdravljenje druge izbire pri bolnicah, katerih bolezen je občutljiva na platino, in alternativa za bolnice, ki so predhodno pokazale toksične reakcije na paklitaksel/karboplatin (zaradi tega je CHMP v usklajenem povzetku glavnih značilnosti zdravila obdržal indikacijo za raka jajčnikov, izraženo z besedilom:
Renal clearance was 2 to 7 l/hr/m2.
Ledvični očistek je bil 2 do 7 l/h/m površine telesa.
Renal failure may not be reversible with discontinuation of therapy and dialysis may be required.
Ob prekinitvi zdravljenja ledvično popuščanje morda ne bo povratno in bo bolnik potreboval dializo.
Before the first infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function.
Pred prvo infuzijo vam bodo vzeli vzorce vaše krvi, da preverijo, če imate ustrezno delovanje ledvic.
Cellular metabolism and mechanism of action: Gemcitabine (dFdC), which is a pyrimidine antimetabolite, is metabolised intracellularly by nucleoside kinase to the active diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides.
Celična presnova in mehanizem delovanja: Gemcitabin (dFdC), ki je pirimidinski antipresnovek, znotrajcelično presnavlja nukleozidna kinaza do aktivnih difosfatnih (dFdCDP)- in trifosfatnih (dFdCTP) nukleozidov.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mg gemcitabine
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 200 mg gemcitabina