natgillin/translations-raw huggingface dataset:
• • • • •
Method of administration
Administrationsmåde Gemcitabin er veltolereret under infusion og kan indgives ambulant.
Gemzar is tolerated well during infusion and may be administered ambulant.
6. 6
Special populations
4. 4 og 5. 2).
Patients with renal or hepatic impairment 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).
Ældre (> 65 år) Gemcitabin er veltolereret af patienter over 65 år.
Elderly population( > 65 years) Gemcitabine has been well tolerated in patients over the age of 65.
5. 2).
There is no evidence to suggest that dose adjustments, other than those already recommended for all patients, are necessary in the elderly (see section 5.2).
Børn (< 18 år) Gemcitabin anbefales ikke til brug til børn under 18 år på grund af utilstrækkelig dokumentation for sikkerhed og virkning.
Paediatric population (< 18 years) Gemcitabine is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.
4. 6).
Breast-feeding (see section 4.6).
Hæmatologisk toksicitet Gemcitabin kan undertrykke knoglemarvsfunktionen, som viser sig ved leukopeni, trombocytopeni og anæmi.
Haematological toxicity Gemcitabine can suppress bone marrow function as manifested by leucopaenia, thrombocytopaenia and anaemia.
21 Perifere blodværdier kan fortsat forværres efter ophør med gemcitabinbehandling.
Peripheral blood counts may continue to deteriorate after gemcitabine administration has been stopped.
Leverinsufficiens Administration af gemcitabin til patienter, som samtidig har levermetastaser eller tidligere har haft hepatitis, alkoholisme eller levercirrose, kan føre til forværring af den tilgrundliggende leverinsufficiens.
21 Hepatic insufficiency Administration of gemcitabine in patients with concurrent liver metastases or a pre-existing medical history of hepatitis, alcoholism or liver cirrhosis may lead to exacerbation of the underlying hepatic insufficiency.
Laboratoriemåling af nyre - og leverfunktion (inklusive virologiske tests) bør foretages regelmæssigt.
Laboratory evaluation of renal and hepatic function (including virological tests) should be performed periodically.
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).
Samtidig røntgenbehandling Samtidig røntgenbehandling (givet samtidig eller ≤ 7 dage derfra):
Concomitant radiotherapy Concomitant radiotherapy (given together or ≤7 days apart):
4. 5 for detaljer og anbefaling vedrørende brugen).
Toxicity has been reported (see section 4.5 for details and recommendations for use).
4. 5).
Live vaccinations Yellow fever vaccine and other live attenuated vaccines are not recommended in patients treated with gemcitabine (see section 4.5).
Kardiovaskulært På grund af risikoen for hjerte og/ eller vaskulære lidelser ved brug af gemcitabin, skal der tages særlige forholdsregler ved behandling af patienter med kardiovaskulære tilfælde i anmnesen.
Cardiovascular 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.
Pulmonært Pulmonære virkninger, som kan være alvorlige (såsom pulmonalt ødem, interstitiel pneumoni og Adult Respiratory Distress Syndrome (ARDS), er set i forbindelse med gemcitabinbehandling.
Pulmonary Pulmonary effects, sometimes severe (such as pulmonary oedema, interstitial pneumonitis or adult respiratory distress syndrome (ARDS)) have been reported in association with gemcitabine therapy.
4. 8).
Renal Clinical findings consistent with the haemolytic uraemic syndrome (HUS) were rarely reported in patients receiving gemcitabine (see section 4.8).
Fertilitet I fertilitetsstudier har gemcitabin forårsaget hypospermatogenese hos hanmus (se pkt.
Fertility In fertility studies gemcitabine caused hypospermatogenesis in male mice (see section 5.3).
Det anbefales også at søge yderligere rådgivning angående kryokonservering af sæd før behandling, på grund af muligheden for infertilitet som følge af behandling med gemcitabin (se pkt 4. 6).
Therefore, men being treated with gemcitabine are advised not to father a child during and up to 6 months after treatment and to seek further advice regarding cryoconservation of sperm prior to treatment because of the possibility of infertility due to therapy with gemcitabine (see section 4.6).
Natrium Gemzar 200 mg indeholder 3, 5 mg (< 1 mmol) natrium pr. hætteglas.
Sodium Gemzar 200 mg contains 3.5 mg (< 1 mmol) sodium per vial.
Dette skal der tages hensyn til ved behandling af patienter på en kontrolleret natrium - eller saltdiæt.
This should be taken into consideration by patients on a controlled sodium diet.
Gemzar 1000 mg indeholder 17, 5 mg (< 1 mmol) natrium pr. hætteglas.
Gemzar 1000 mg contains 17.5 mg (< 1 mmol) sodium per vial.
5. 2)
No specific interaction studies have been performed (see section 5.2)
Strålebehandling Samtidig behandling (administreret samtidigt eller ≤ 7 dages mellemrum) - Toksicitet forbundet med denne multimodale behandling afhænger af mange forskellige faktorer, blandt andet dosis af gemcitabin, hyppighed af gemcitabinadministration, stråledosis, planlægningsteknikken for strålebehandlingen, det tumorvæv, som er mål for behandlingen, og tumorstørrelsen.
Radiotherapy Concurrent (given together or ≤ 7 days apart) - Toxicity associated with this multimodality therapy is dependent on many different factors, including dose of gemcitabine, frequency of gemcitabine administration, dose of radiation, radiotherapy planning technique, the target tissue, and target volume.
Dette blev især observeret hos patienter, der fik store mængder strålebehandling [median behandlingsvolumen 4795 cm3].
In a single trial, where gemcitabine at a dose of 1,000 mg/m2 was administered concurrently for up to 6 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].
Senere undersøgelser indikerer, at det er muligt at administrere gemcitabin i lavere doser med samtidig strålebehandling med en forudsigelig toksicitet, som i et fase II studie af ikke- småcellet lungecancer, hvor der blev anvendt torakalbestråling i doser på 66Gy samtidig med gemcitabin (600 mg/ m2 4 gange) og cisplatin (80 mg/ m2, to gange) i løbet af 6 uger.
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.
Ikke samtidig behandling (> 7 dages mellemrum) - Der foreligger ikke data, som indikerer betydelig øget toksicitet, når gemcitabin indgives mere end 7 dage før eller efter strålebehandling, bortset fra en genkaldelse af strålebivirkningerne.
Non-concurrent (given > 7 days apart)- Analysis of the data does not indicate any enhanced toxicity when gemcitabine is administered more than 7 days before or after radiation, other than radiation recall.
Der er rapporteret om stråleskade på det tumorvæv, som er mål for behandlingen (f. eks. øsofagitis, colitis og pneumoni) både i forbindelse med samtidig og ikke- samtidig brug af gemcitabin.
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.
Andre Gul feber vaccine og andre levende, svækkede vacciner anbefales ikke, på grund af risikoen for systemisk sygdom, som kan være fatal, specielt hos patienter med immunosuppression.
Others Yellow fever and other live attenuated vaccines are not recommended due to the risk of systemic, possibly fatal, disease, particularly in immunosuppressed patients.
Graviditet Der foreligger ikke tilstrækkelige data om brugen af gemcitabin til gravide kvinder.
Pregnancy There are no adequate data from the use of gemcitabine in pregnant women.
Amning Det er uvist om gemcitabin udskilles i modermælken, og bivirkninger hos det diende barn kan ikke udelukkes.
Breast-feeding It is not known whether gemcitabine is excreted in human milk and adverse effects on the suckling child cannot be excluded.
5. 3).
Fertility In fertility studies gemcitabine caused hypospermatogenesis in male mice (see section 5.3).
23 4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effects on ability to drive and use machines
Det er dog rapporteret, at gemcitabin kan forårsage mild til moderat somnolens, særligt i kombination med alkoholindtag.
However, gemcitabine has been reported to cause mild to moderate somnolence, especially in combination with 23 alcohol consumption.
Allergiske hududslæt forekommer hos omkring 25% af patienterne og er associeret med kløe hos 10% af patienterne.
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.
4. 4).
The frequency and severity of the adverse reactions are affected by the dose, infusion rate and intervals between doses (see section 4.4).
4. 2).
Dose-limiting adverse reactions are reductions in thrombocyte, leucocyte and granulocyte counts (see section 4.2).
Data fra kliniske undersøgelser Frekvenser er defineret som: meget almindelig (1/ 10), almindelig (1/ 100 til < 1/ 10), ikke almindelig (1/ 1. 000 til 1/ 100), sjælden (1/ 10. 000 til 1/ 1. 000), meget sjælden (< 1/ 10. 000).
Very common (≥1/10), Common (≥1/100 to < 1/10), Uncommon (≥1/1000 to < 1/100), Rare (≥1/10,000 to < 1/1000), Very Rare (< 1/10,000).
Hjerte Sjælden (1/ 10. 000 til
Frequency grouping Very common • Leucopaenia (Neutropaenia Grade 3 = 19.3%; Grade 4 = 6%).
1/ 1. 000)
Common • Febrile neutropaenia Very rare • Thrombocytosis
Hjerteinfarkt
Immune system disorders
Blod og lymfesystem Meget almindelig (1/ 10)
Very Rare • Anaphylactoid reaction
Leukopeni (Neutropeni: hyppigheden for hhv.
Metabolism and nutrition disorders
Grade 3 og Grade 4 er 19. 3% og 6%)
Common • Anorexia
4. 2) Thrombocytopeni Anæmi
Nervous system disorders
Almindelig (1/ 100 til < 1/ 10)
Common • Headache • Insomnia • Somnolence
Febril neutropeni
Cardiac disorders
Meget sjælden (< 1/ 10. 000)
Rare • Myocardial infarct
Thrombocytose
Vascular disorders
Nervesystemet Almindelig (1/ 100 til < 1/ 10)
Rare • Hypotension
24 Luftveje, thorax og mediastinum Meget almindelig (1/ 10)
24 System Organ Class Respiratory, thoracic and mediastinal disorders
Dyspnø – sædvanligvis mild og ophører hurtigt uden behandling
Frequency grouping Very common • Dyspnoea –usually mild and passes rapidly without treatment
Almindelig (1/ 100 til < 1/ 10)
Common • Cough • Rhinitis
4. 4), bronkospasme – sædvanligvis mild og kortvarig, men kan kræve parenteral behandling
Uncommon • Interstitial pneumonitis (see section 4.4) • Bronchospasm –usually mild and transient but may require parenteral treatment Gastrointestinal disorders
Meget almindelig (1/ 10)
Very common • Vomiting • Nausea
Almindelig (1/ 100 til < 1/ 10)
Common • Diarrhoea • Stomatitis and ulceration of the mouth • Constipation
Hæmaturi og mild proteinuri
Hepatobiliary disorders
Hud og subkutane væv Meget almindelig (1/ 10)
Very common • Elevation of liver transaminases (AST and ALT) and alkaline phosphatase
Almindelig (1/ 100 til < 1/ 10)
Common • Increased bilirubin
Kløe, svedtendens
Rare
1/ 1. 000)
•
Ulceration, blære - og sårdannelse, eksfoliation
Increased gamma-glutamyl transferase (GGT)
Alvorlige hudreaktioner, herunder udbredt
Skin and subcutaneous tissue disorders
Meget sjælden (< 1/ 10. 000)
Very common • Allergic skin rash frequently associated with pruritus • Alopecia
Almindelig (1/ 100 til < 1/ 10)
Common • Itching • Sweating
Rygsmerter, myalgi
Rare
Almindelig (1/ 100 til < 1/ 10)
• • •
Traumer, forgiftninger og behandlingskomplikationer
Ulceration Vesicle and sore formation Scaling
Frekvens ikke kendt (kan ikke estimeres fra tilgængelige data)
Very rare • Severe skin reactions, including desquamation and bullous skin eruptions Musculoskeletal and connective tissue disorders
Vaskulære sygdomme Sjælden (1/ 10. 000 til 1/ 1. 000)
Common • Back pain • Myalgia
25 Almene symptomer og reaktioner på administrationsstedet Meget almindelig (1/ 10)
25
Ødemer/ perifere ødemer inklusive ansigtsødem.
System Organ Class Renal and urinary disorders
Ødemer er sædvanligvis reversible efter behandlingsophør
Frequency grouping Very Common • Haematuria • Mild proteinuria
Feber, asteni, kulderystelser
General disorders and administration site conditions
Almindelig (1/ 100 til < 1/ 10) Reaktioner på administrationsstedet – hovedsageligt milde af natur Sjælden (≥1/ 10. 000 til < 1/ 1. 000)
Very common • Influenza-like symptoms - the most common symptoms are fever, headache, chills, myalgia, asthenia and anorexia.
Immunsystemet Meget sjælden (< 1/ 10. 000)
Oedema is usually reversible after stopping treatment
Anafylaktoide reaktioner.
Common • Fever • Asthenia • Chills
Lever og galdeveje
Rare
Meget almindelig (1/ 10)
•
Forhøjede levertransaminaser (ASAT/ ALAT) og basiske fosfataser
Injection site reactions-mainly mild in nature
Almindelig (≥1/ 100 til < 1/ 10)
Injury, poisoning, and procedural Complications
Forhøjet bilirubin
Radiation toxicity (see section 4.5).
Sjælden (1/ 10. 000 til 1/ 1. 000)
Postmarketing experience (spontaneous reports) frequency not known (can’t be estimated from the available data)
Forhøjet gammaglutamyltransferase (GGT)
Nervous system disorders Cerebrovascular accident
Postmarketing erfaring (spontane indberetninger) ikke kendt frekvens (kan ikke estimeres ud fra forhåndenværende data)
Cardiac disorders Arrythmias, predominantly supraventricular in nature Heart failure
Hjerte Arytmier, hovedsaglig af supraventrikulær karakter Hjerteinsufficiens
Vascular disorders Clinical signs of peripheral vasculitis and gangrene
4. 4)
Respiratory, thoracic and mediastinal disorders Pulmonary oedema Adult respiratory distress syndrome (see section 4.4)
Mave- tarmkanalen Iskæmisk colitis
Gastrointestinal disorders Ischaemic colitis
Vaskulære sygdomme Kliniske tegn på perifer vaskulitis og gangræn
Hepatobiliary disorders Serious hepatotoxicity, including liver failure and death
4. 4)
26 Renal and urinary disorders Renal failure (see section 4.4) Haemolytic uraemic syndrome (see section 4.4)
Kombinationsbehandling ved brystcancer Frekvensen af grad 3 og 4 hæmatologiske toksiciteter, specielt neutropeni, stiger når gemcitabin anvendes i kombination med paclitaxel.
Combination use in breast cancer The frequency of grade 3 and 4 haematological toxicities, particularly neutropaenia, increases when gemcitabine is used in combination with paclitaxel.
Grad 3 og 4 bivirkninger Paclitaxel versus gemcitabin plus paclitaxel Antal (%) patienter
Grade 3 and 4 Adverse Events Paclitaxel versus gemcitabine plus paclitaxel
Paclitaxel arm (N=259)
Number (%) of Patients
Gemcitabin plus paclitaxel arm (N=262)
Paclitaxel arm
Laboratorieværdier
Gemcitabine plus
Grad 4
(N=259)
Grad 3 Grad 4
Paclitaxel arm (N=262)
Anæmi Trombocytopeni
Laboratory
5 (1, 9) 0
Grade 3
1 (0, 4) 0
Grade 4 Grade 3
3 (1, 1) 1 (0, 4)
Grade 4
Neutropeni Ikke - laboratorieværdier
Anaemia Thrombocytopaenia
11 (4, 2)
11 (4.2)
17 (6, 6) *
17 (6.6)*
82 (31, 3)
82 (31.3)
45 (17, 2) *
45 (17.2)*
Febril neutropeni Træthed Diarré Motorisk neuropati Sensorisk neuropati *
Non-laboratory
3 (1, 2) 3 (1, 2) 5 (1, 9) 2 (0, 8) 9 (3, 5)
Febrile neutropaenia
0 1 (0, 4) 0 0 0
3 (1.2)
12 (4, 6) 15 (5, 7) 8 (3, 1) 6 (2, 3) 14 (5, 3)
12 (4.6)
1 (0, 4) 2 (0, 8) 0 1 (0, 4) 1 (0, 4)
3 (1.2) 5 (1.9)
Grad 4 neutropeni, som varer mere end 7 dage, forekom hos 12, 6% af patienterne i kombinationsarmen og hos 5, 0% af patienterne i paclitaxelarmen.
*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.
27 Kombinationsbehandling ved blærecancer
27 Combination use in bladder cancer
Grad 3 og 4 bivirkninger MVAC versus gemcitabin plus cisplatin Antal (%) patienter
Grade 3 and 4 Adverse Events MVAC versus Gemcitabine plus cisplatin
MVAC (methotrexat, vinblastin, doxorubicin og cisplatin) arm (N=196)
MVAC (methotrexate, vinblastine, doxorubicin and cisplatin) arm (N=196)
Laboratorieværdier
Laboratory
Grad 3 Grad 4
Grade 4 Grade 3
Grad 3 Grad 4
Grade 4
Anæmi Trombocytopeni Ikke - laboratorieværdier
Anaemia Thrombocytopaenia Non-laboratory
47( 24) 7( 4) 57( 29) 57( 29)
4(2) 47(24) 25(13) 57(29)
37( 19) 3( 2)
7(4) 57(29)
44( 22) 0( 0)
Nausea and vomiting Diarrhoea Infection Stomatitis
Diarré Infektion Stomatitis
37(19) 15(8) 19(10) 34(18)
15( 8) 1( 1) 19( 10) 10( 5) 34( 18) 8( 4)
3(2) 44(22) 1(1) 6(3) 10(5) 4(2) 8(4) 2(1)
6( 3) 0( 0) 4( 2) 1( 1) 2( 1) 0( 0)
0(0) 0(0) 1(1) 0(0)
Grad 3 og 4 bivirkninger Carboplatin versus gemcitabin plus carboplatin Antal (%) patienter
Grade 3 and 4 Adverse Events Carboplatin versus Gemcitabine plus carboplatin Number (%) of Patients
Carboplatin arm (N=174)
Carboplatin arm (N=174)
plus carboplatin arm (N=175)
Gemcitabine plus carboplatin arm (N=175)
Grad 4 Grad 3
Grade 4 Grade 3
Anæmi
4(2.3)
10( 5, 7)
39(22.3)
4( 2, 3)
9(5.1)
39( 22, 3)
19(10.9)
9( 5, 1)
2(1.1)
Neutropeni Thrombocytopeni Leukopeni Ikke - laboratorieværdier
50(28.6)
19( 10, 9) 18( 10, 3) 11( 6, 3)
Thrombocytopaenia
2( 1, 1) 2( 1, 1) 1( 0, 6)
53(30.3)
73( 41, 7) 53( 30, 3) 84( 48, 0)
Leucopaenia
50( 28, 6) 8( 4, 6) 9( 5, 1)
Non-laboratory
Blødning Febril neutropeni Infektion uden neutropeni
Haemorrhage
0( 0, 0) 0( 0, 0) 0( 0)
0(0.0) 0(0.0)
0( 0, 0) 0( 0, 0) 0( 0, 0)
3 (1.8)
Sensorisk neuropati var også mere hyppigt forekommende ved kombinationsbehandlingen end ved behandling med carboplatin alene.
Sensory neuropathy was also more frequent in the combination arm than with single agent carboplatin
Der findes ingen kendt antidot mod gemcitabin ved overdosering.
There is no known antidote for overdose of gemcitabine.
Enkeltdoser op til 5700 mg/ m2 er blevet givet ved intravenøs infusion over 30 minutter, hver 2. uge, med klinisk acceptabel toksicitet.
Doses as high as 5700 mg/m2 have been administered by intravenous infusion over 30-minutes every 2 weeks with clinically acceptable toxicity.
Farmakoterapeutisk klassifikation: pyrimidin analoger, ATC- kode:
Pharmacotherapeutic group: pyrimidine analogues ATC code:
L 01 BC 05
L01BC05
Cytotoksisk aktivitet i cellekulturer Gemcitabin udviser betydelig cytotoksicitet overfor en række forskellige murine og humane tumorceller i cellekultur.
Cytotoxic activity in cell cultures Gemcitabine shows significant cytotoxic effects against a variety of cultured murine and human tumour cells.
Virkningen er fasespecifik, idet gemcitabin primært dræber celler, der undergår DNA- syntese (S - fase) og under visse forhold blokerer cellecyklus på grænsen mellem G1 og S- fasen.
Its action is phase-specific such that gemcitabine primarily kills cells that are undergoing DNA synthesis (S-phase) and, under certain circumstances, blocks the progression of cells at the junction of the G1/S phase boundary.
In vitro er den cytotoksiske effekt af gemcitabin både koncentrations - og tidsafhængig.
In vitro, the cytotoxic effect of gemcitabine is dependent on both concentration and time.
Antitumoraktivitet i prækliniske modeller I dyremodeller er gemcitabins antitumoraktivitet afhængig af administrationsfrekvensen.
Antitumoral activity in preclinical models In animal tumour models, antitumoural activity of gemcitabine is schedule-dependent.
Gives gemcitabin derimod hver 3. eller 4. dag, kan det gives i ikke- letale doser, med betydelig antitumoraktivitet mod et bredt spektrum af musetumorer.
If, however, gemcitabine is given every third or fourth day, it can be administered in non- lethal doses with substantial antitumoural activity against a broad spectrum of mouse tumours.
Virkningsmekanisme Cellulær metabolisme og virkningsmekanisme Gemcitabin (difluordeoxycytidin DfdC), som er en pyrimidin antimetabolit, metaboliseres intracellulært af nukleosid- kinaser til de aktive difosfat - (dFdCDP) og trifosfat - (dFdCTP) nukleosider.
Gemcitabine (dFdC), which is a pyrimidine antimetabolite, is metabolised intracellularly by nucleoside kinase to the active diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides.
Den cytotoksiske effekt af gemcitabin skyldes en hæmning af DNA- syntesen ved hjælp af to virkningsmekanismer af dFdCDP og dFdCTP.
The cytotoxic effect of gemcitabine is due to inhibition of DNA synthesis by two mechanisms of action by dFdCDP and dFdCTP.
For det første hæmmer dFdCDP ribonukleotid- reduktase, som er den eneste katalysator for produktionen af deoxynukleosid- trifosfater til DNA- syntesen.
First, dFdCDP inhibits ribonucleotide reductase, which is uniquely responsible for catalysing the reactions that produce deoxynucleoside triphosphates (dCTP) for DNA synthesis.
DNA polymerase er ikke i stand til at fjerne gemcitabin og reparere de voksende DNA- strenge.
DNA polymerase epsilon lacks the ability to eliminate gemcitabine and to repair the growing DNA strands.
Efter gemcitabin er optaget i DNA øges de voksende DNA- strenge med et ekstra nukleotid.
After gemcitabine is incorporated into DNA, one additional nucleotide is added to the growing DNA strands.
Denne nukleotidforøgelse betyder i princippet en fuldstændig hæmning af den fortsatte DNA- syntese (maskeret kædeterminering).
After this addition there is essentially a complete inhibition in further DNA synthesis (masked chain termination).
Kliniske data Blærecancer En randomiseret fase III undersøgelse med 405 patienter med fremskreden eller metastatisk urothelialt transitiocellulært karcinom, sås ingen forskel mellem de to behandlingsarme, gemcitabin/ cisplatin versus methotrexat/ vinblastin/ adriamycin/ cisplatin (MVAC), hvad angår median overlevelse (henholdsvis 12, 8 måneder og 14, 8 måneder, p=0, 547), tid til progression i sygdommen (henholdsvis 7, 4 måneder og 7, 6 måneder, p=0, 842) og responsrate (henholdsvis 49, 4% og 45, 7%, p=0, 512).
Clinical data Bladder cancer A randomised phase III study of 405 patients with advanced or metastatic urothelial transitional cell carcinoma showed no difference between the two treatment arms, gemcitabine/cisplatin versus methotrexate/vinblastine/adriamycin/cisplatin (MVAC), in terms of median survival (12.8 and 14.8 months respectively, p=0.547), time to disease progression (7.4 and 7.6 months respectively, p=0.842) and response rate (49.4% and 45.7% respectively, p=0.512).
Pancreascancer I en randomiseret fase III undersøgelse af 126 patienter med fremskreden eller metastatisk pancreascancer viste gemcitabin en statistisk signifikant højere responsrate end 5- fluorouracil udtrykt ved klinisk forbedring (henholdsvis 23, 8% og 4, 8%; p=0, 0022).
Pancreatic cancer 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).