natgillin/translations-raw huggingface dataset:
Anti-tumoraktivitet blev vist primært hos patienter med neuroblastoma. 
Anti-tumour activity was demonstrated primarily in patients with neuroblastoma.
Det er vigtigt med en omhyggelig vurdering af performancestatus ved påbegyndelse af behandling for at sikre, at patienter ikke forværres til PS 3. 
Accurate assessment of performance status at the time therapy is given is important, to ensure that patients have not deteriorated to PS 3.
Recidiverende SCLC 
Relapsed SCLC
Topotecan havde ligeledes et højt distributionsvolumen på omkring 132 l (SD 57), samt en relativ kort halveringstid på 2-3 timer. 
Topotecan also had a high volume of distribution, about 132 l (SD 57), and a relatively short half-life of 2-3 hours.
Instruktion i rekonstitution, opbevaring og bortskaffelse af Hycamtin 
Instructions on how to reconstitute, store and dispose of Hycamtin
Der sås ingen generelle forskelle i effektivitet hos patienter i alderen over 65 år i forhold til yngre voksne patienter. 
No overall differences in effectiveness were observed between patients aged over 65 years and younger adult patients.
• Lette smerter og betændelse på injektionsstedet. 
• Mild pain and inflammation at the site of injection.
Hycamtin indeholder ethanol Dette lægemiddel indeholder små mængder ethanol (alkohol). 
Hycamtin contains ethanol This medicine contains small amounts of ethanol (alcohol).
Kontakt straks lægen, hvis du får nogle af disse symptomer, da indlæggelse på hospital kan være nødvendig. 
Tell your doctor immediately if you get any symptoms of these conditions, as hospitalisation may be necessary.
• Lægen har ordineret dette lægemiddel til dig personligt. 
• This medicine has been prescribed for you.
Total optagelse (AUC) øges omtrent proportionalt med dosis. 
Total exposure (AUC) increases approximately proportionally with dose.
Koreanske patienter med nedsat nyrefunktion havde generelt højere eksponering end ikke-asiatiske patienter med samme grad af nedsat nyrefunktion. 
Korean patients with renal impairment had generally higher exposure than non-Asian patients with the same degree of renal impairment.
Første dosis 
Initial dose
Forsøg ikke at blive gravid før lægen siger, at det er sikkert. 
Do not try to become pregnant until a doctor advises you it is safe to do so.
Medianoverlevelsen for de to grupper var 25,0 henholdsvis 24,7 uger. 
Median survivals for the two groups were 25.0 and 24.7 weeks, respectively.
Camberley, Surrey GU16 7SR Storbritannien 
Camberley, Surrey GU16 7SR United Kingdom
Begrænsede data indikerer, at dosis bør reduceres hos patienter med moderat nedsat nyrefunktion. 
Limited data indicate that the dose should be reduced in patients with moderate renal impairment.
Hvis du får diarré mere end 3 gange på en dag, skal du straks kontakte lægen. 
If you have more than 3 episodes of diarrhoea per day you should contact your doctor immediately.
Overlevelse (mdr.) 
Survival (months)
Topotecan er et substrat for både ABCB1 (P-glycoprotein) og ABCG2 (BCRP). 
Topotecan is a substrate for both ABCB1 (P-glycoprotein) and ABCG2 (BCRP).
Blandt alle patienter, der blev behandlet i de kliniske studier (herunder både dem med alvorlig neutropeni og dem, der ikke udviklede alvorlig neutropeni), udviklede 11 % (4 % af serierne) feber, og 26 % (9 % af serierne) udviklede infektion. 
Among all patients treated in clinical studies (including both those with severe neutropenia and those who did not develop severe neutropenia), 11% (4% of courses) developed fever and 26% (9% of courses) developed infection.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE / FORNYELSE AF TILLADELSEN 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
• din kropsstørrelse (overfladeareal målt i kvadratmeter) 
• your body size (surface area measured in square metres)
• resultaterne af blodprøverne, der er udført inden behandlingens start Det anførte antal kapsler skal tages en gang daglig i 5 dage. 
• the results of blood tests carried out before treatment The prescribed number of capsules should be swallowed whole, once a day for 5 days.
Halveringstiden for topotecan steg med ca. 30 %, men der observeredes ingen åbenbar ændring i distributionsvolumen. 
Topotecan half-life was increased by about 30% but no clear change in volume of distribution was observed.
Den totale forekomst af lægemiddelrelateret diarré var 22 % herunder 4 % af grad 3 og 0,4 % af grad 4. 
The overall incidence of drug-related diarrhoea was 22%, including 4% with Grade 3 and 0.4% with Grade 4.
I et populationsstudie havde et antal faktorer, herunder alder, vægt og ascites ingen signifikant virkning på clearance af total-topotecan (aktiv og inaktiv form). 
In a population study, a number of factors including age, weight and ascites had no significant effect on clearance of total topotecan (active and inactive form).
Pædiatrisk population Sikkerheden og effektiviteten af oral topotecan er ikke fastlagt for pædiatriske patienter. 
Paediatric population The safety and effectiveness of oral topotecan in paediatric patients have not been established.
Som det ville være forventet har patienter med dårlig performancestatus (PS > 1) en lavere responsrate og en øget forekomst af komplikationer såsom feber, infektion og sepsis (se pkt. 
As would be expected, patients with poor performance status (PS >1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Topotecan har også vist sig at forårsage embryo- og fosterdødelighed, når det gives til rotter og kaniner. 
Topotecan was also shown to cause embryo-foetal lethality when given to rats and rabbits.
Intravenøs anvendelse. 
Intravenous use.
Der var i disse studier ikke nogen synlige forskelle i farmakokinetikken af topotecan hos børn, unge og yngre voksne med solide tumorer eller leukæmi, men data er for begrænsede til en definitiv konklusion. 
In these studies there were no apparent differences in the pharmacokinetics of topotecan among children, adolescents and young adult patients with solid tumours or leukaemia, but data are too limited to draw definite conclusions.
Tabel 1 Oversigt over overlevelse, responsrate og tid til progression hos SCLC-patienter, der er behandlet med oral eller intravenøs topotecan 
Table 1 Summary of survival, response rate, and time to progression in SCLC patients treated with oral or intravenous topotecan
Der kan være behov for at justere din dosis af Hycamtin. 
Your dose of Hycamtin may need to be adjusted.
• hvis du har nyre- eller leverproblemer. 
• if you have any kidney or liver problems.
• fremskreden livmoderhalskræft, hvor behandling med kirurgi eller stråleterapi ikke er mulig. 
• advanced cervical cancer if surgery or radiotherapy treatment is not possible.
Bivirkningerne nævnt herunder er opdelt efter systemorganklasse og absolut hyppighed (alle indberettede hændelser). 
Adverse reactions are listed below, by system organ class and absolute frequency (all reported events).
De normale procedurer for korrekt håndtering og bortskaffelse af anticancermedicin skal overholdes, dvs.: 
The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted, namely:
Lægemiddelrelateret diarré var hyppigere hos patienter ≥ 65 år (28 %) sammenlignet med dem, der var yngre end 65 år (19 %). 
Drug-related diarrhoea was more frequent in patients 65 years of age (28%) compared to those less than 65 years of age (19%).
Hvis en kapsel går i stykker, eller åbner sig, skal du straks vaske hænderne grundigt med vand og sæbe. 
If the capsules are punctured or leaking, you should immediately wash your hands thoroughly with soap and water.
Biotilgængeligheden ved oral topotecan (totalt og lakton) hos mennesker er ca. 40 %. 
The bioavailability of oral topotecan (total and lactone) in humans is approximately 40%.
• Personalet skal være uddannet i at rekonstituere lægemidlet. 
• Staff should be trained to reconstitute the medicinal product.
En supplerende retrospektiv analyse blev udført på data fra 523 patienter med recidiverende ovariecancer. 
A supplementary retrospective analysis was conducted on data from 523 patients with relapsed ovarian cancer.
Denne serie gentages hver 21. dag seks gange eller indtil progression af sygdommen. 
This treatment schedule is repeated every 21 days for six courses or until progressive disease.
Hycamtin hjælper med til at ødelægge tumorer. 
Hycamtin helps to destroy tumours.
Det karcinogene potentiale af topotecan er ikke undersøgt. 
The carcinogenic potential of topotecan has not been studied.
Du vil få behandling en gang daglig i 5 dage. 
You will have treatment once a day for 5 days.
En reduktion i topotecan clearance blev observeret. 
A reduction in topotecan clearance was observed.
5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering. 
Currently available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.
Af de patienter, som fik flere end 6 serier kemoterapi, fuldførte 91 % studiet som planlagt eller blev behandlet, indtil sygdommen progredierede, og heraf blev kun 3 % ekskluderet på grund af bivirkninger. 
Of the patients who received more than 6 cycles of therapy, 91% completed the study as planned or were treated until disease progression, with only 3% withdrawn for adverse events.
Hos patienter, som har feber, neutropeni og et kompatibelt mønster med mavesmerter, bør risikoen for neutropenisk colitis overvejes. 
In patients presenting with fever, neutropenia and a compatible pattern of abdominal pain, the possibility of neutropenic colitis should be considered.
Den dosis (og antal kapsler) af Hycamtin, som du vil få, vil blive beregnet af din læge på basis af: 
The dose (and number of capsules) of Hycamtin you are given will be worked out by your doctor, based on:
Patienter med kreatinin-clearance > 60 ml/min er blevet inkluderet i virkning/sikkerheds-studier med topotecan. 
Patients with creatinine clearance >60 ml/min have been included in efficacy/safety studies of topotecan.
Lysegult til grønligt pulver. 
Light yellow to greenish powder.
10 kapsler 
10 capsules
Tilsvarende resultater blev set, når glomerulær filtrationshastighed (ml/min) blev estimeret ved anvendelse af MDRD-formlen korrigeret for patientens vægt. 
Similar results were obtained if glomerular filtration rate (ml/min) was estimated using the MDRD formula corrected for body weight.
Hycamtin bruges til at behandle: 
Hycamtin is used to treat:
Bivirkninger, hvor hyppigheden ikke er kendt 
Side effects with frequency not known
Mediantid til progression var ens i de to grupper (13,3 uger henholdsvis 12,3 uger). 
Median time to progression was similar in the two groups (13.3 weeks and 12.3 weeks, respectively).
Responsraten i hele ovariecancerprogrammet (n = 392, alle tidligere behandlet med cisplatin eller cisplatin og paclitaxel) var 16 %. 
The response rate in the whole ovarian carcinoma programme (n = 392, all previously treated with cisplatin or cisplatin and paclitaxel) was 16%.
Din læge vil sammen med dig beslutte, om behandling med Hycamtin er bedre end at fortsætte med den kemoterapibehandling, du tidligere har fået. 
Your doctor will decide with you whether Hycamtin therapy is better than further treatment with your initial chemotherapy.
Disse data bør evalueres i lyset af den totale sikkerhedsprofil af lægemidlet, specielt den signifikante hæmatologiske toksicitet (se pkt. 
These data should be evaluated in the context of the overall safety profile of the medicinal product, in particular of the significant haematological toxicity (see section 4.8).
Topotecan-monoterapi er indiceret til behandling af: 
Topotecan monotherapy is indicated for the treatment of:
De primære komplikationer forbundet med overdosering er knoglemarvssuppression og mucositis. 
The primary complications of overdose are bone marrow suppression and mucositis.
Som med al cytotoksisk kemoterapi skal patienter, der behandles med topotecan, rådes til, at de eller deres partner skal anvende en effektiv præventionsmetode. 
As with all cytotoxic chemotherapy, patients being treated with topotecan must be advised that they or their partner must use an effective method of contraception.
• Alvorlige allergiske eller anafylaktiske reaktioner. 
• Severe allergic or anaphylactic reactions.
Dødsfald pga. sepsis sås hos 1 % af patienterne. 
Death due to sepsis occurred in 1% of patients.
Håndtering og bortskaffelse 
Handling and disposal
Symptomerne omfatter: feber alvorlig forværring af din generelle tilstand lokale symptomer såsom ondt i halsen eller urinvejsproblemer (f.eks. en brændende følelse, når du tisser, hvilket kan skyldes en urinvejsinfektion). 
Signs include: fever serious deterioration of your general condition local symptoms such as sore throat or urinary problems (for example, a burning sensation when urinating, which may be a urinary infection).
Rekonstituerede og fortyndede opløsninger 
Reconstituted and diluted solutions
Der var ingen tegn på kumulativ hæmatologisk eller non-hæmatologisk toksicitet. 
There were no signs of cumulative haematological or non-haematological toxicity.
Der findes ikke nogen kendt antidot mod topotecan-overdosering. 
There is no known antidote for topotecan overdose.
Topotecan-induceret neutropeni kan medføre neutropenisk colitis. 
Topotecan-induced neutropenia can cause neutropenic colitis.
Hvis du har glemt at tage Hycamtin 
If you forget to take Hycamtin
Tryk kapslen ud ved forsigtigt at trykke den ene ende gennem folien. 
Push out the capsule: gently push one end of the capsule through the foil layer.
Metabolisme udgør < 10 % af topotecans eliminering. 
Metabolism accounts for <10% of the elimination of topotecan.
Den dosis af Hycamtin, som du vil få, vil blive beregnet af din læge på basis af: 
The dose of Hycamtin you are given will be worked out by your doctor, based on:
Diarré, der relateres til oral topotecan, kan forekomme på samme tid som lægemiddelrelateret neutropeni og dets følger. 
Diarrhoea related to oral topotecan can occur at the same time as drug-related neutropenia and its sequelae.
Patienter bør monitoreres for pulmonale symptomer, der indikerer ILD (f.eks. hoste, feber, dyspnø og/eller hypoxia), og topotecan bør seponeres, hvis en ny diagnose af ILD bekræftes. 
Patients should be monitored for pulmonary symptoms indicative of ILD (e.g. cough, fever, dyspnoea and/or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed.
Kommunikation med patienterne vedrørende disse bivirkninger og om proaktiv behandling af tidlige tegn, samt alle tegn og symptomer på diarré, er vigtig før administration af lægemidlet. 
Communication with patients prior to drug administration regarding these side effects and proactive management of early and all signs and symptoms of diarrhoea is important.
Tag altid lægemidlet nøjagtigt efter lægens anvisning. 
Always take this medicine exactly as your doctor has told you.
Sammenligning af farmakokinetiske parametre viste ingen farmakokinetiske ændringer i løbet af de 5 doseringsdage. 
Comparison of pharmacokinetic parameters did not suggest any change in pharmacokinetics over the 5 days of dosing.
Total eller udtalt alopeci blev observeret hos 30 % af patienterne, og partiel alopeci hos 15 % af patienterne. 
Total or pronounced alopecia was observed in 30% of patients and partial alopecia in 15% of patients.
Infektioner og parasitære sygdomme Meget almindelig Infektion Almindelig 
Infections and infestations Very common Infection Common
Et cross-study studie med 217 patienter med fremskredne solide tumorer tyder på, at kønsforskelle ikke påvirkede farmakokinetikken af HYCAMTIN kapsler i et klinisk relevant omfang. 
A cross-study analysis in 217 patients with advanced solid tumours indicated that gender did not affect the pharmacokinetics of HYCAMTIN capsules to a clinically relevant extent.
Indehaver af markedsføringstilladelsen Novartis Europharm Limited Vista Building 
Marketing Authorisation Holder Novartis Europharm Limited Vista Building
Mediantiden til indtræden af diarré af grad 2 eller værre var 9 dage. 
The median time to onset of Grade 2 or worse diarrhoea was 9 days.
Infektion, sepsis og febril neutropeni sås hos henholdsvis 17 %, 2 % og 4 % af patienterne. 
Infection, sepsis and febrile neutropenia occurred in 17%, 2%, and 4% of patients, respectively.
Du vil få behandling en gang daglig i 3 dage. 
You will have treatment once a day for 3 days.
Hård kapsel. 
Hard capsule.
2, forstoppelse, mucositis, dyspepsi 
2, constipation, mucositis, dyspepsia
Proaktiv behandling af diarré med midler mod diarré er vigtig. 
Proactive management of diarrhoea with anti-diarrhoeal agents is important.
In vitro data på humane levermikrosomer indikerer dannelsen af små mængder af N-demethyleret topotecan. 
In vitro data using human liver microsomes indicate the formation of small amounts of Ndemethylated topotecan.
Når topotecan gives sammen med andre kemoterapeutika, kan det være nødvendigt at reducere dosis af de enkelte lægemidler for at forbedre tolerancen. 
When combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
Topotecan hæmmer ikke humane P450-enzymer (se pkt. 
Topotecan does not inhibit human P450 enzymes (see section 5.2).
Hvis du får kapslens indhold i øjet, skal du straks skylle forsigtigt med vand i mindst 15 minutter. 
If you get the capsule contents in your eyes, wash them immediately with gently flowing water for at least 15 minutes.
Eventuelt ubrugt lægemiddel eller affald bør bortskaffes i overensstemmelse med lokale krav til cytotoksisk materiale. 
Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic material.
Selvom det ikke vides, om topotecan udskilles i human brystmælk, skal amning stoppes ved behandlingsstart. 
Although it is not known whether topotecan is excreted in human breast milk, breast-feeding should be discontinued at the start of therapy.
Indhold i kapslen Hydrogeneret vegetabilsk olie Glycerolmonostearat 
Capsule contents Hydrogenated vegetable oil Glyceryl monostearate
Pulveret skal opløses og fortyndes før infusion. 
The powder needs to be reconstituted and diluted before infusion.
Farmakokinetikken for HYCAMTIN kapsler er ikke undersøgt specifikt hos patienter med nedsat leverfunktion. 
Pharmacokinetics of HYCAMTIN capsules have not been specifically studied in patients with impaired hepatic function.
Kombinationsterapi (cervixcancer): 
Combination therapy (cervical carcinoma):
Farmakokinetikken af topotecan givet som intravenøs infusion over 30 minutter i 5 dage er undersøgt i to studier. 
The pharmacokinetics of topotecan given as a 30-minute infusion for 5 days were evaluated in two studies.
Diarré herunder alvorlig diarré, der kræver hospitalsindlæggelse, er set ved behandling med oral topotecan. 
Diarrhoea, including severe diarrhoea requiring hospitalisation, has been reported during treatment with oral topotecan.
• Usædvanlige blå mærker eller blødninger, der er forårsaget af en nedsættelse i antallet af de celler, som får blodet til at størkne. 
• Unusual bruising or bleeding, caused by a decrease in the number of clotting cells in the blood.
Medianoverlevelsen var 30,3 uger (95 % CI: 27,6; 33,4). 
Median survival was 30.3 weeks (95% CI: 27.6, 33.4).
Farmakoterapeutisk klassifikation: antineoplastiske stoffer, andre antineoplastiske stoffer: ATC-kode: L01XX17. 
Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents: ATC code: L01XX17.
Kvinder i den fertile alder/prævention til mænd og kvinder 
Women of childbearing potential / Contraception in males and females
Administration af topotecan til børn er undersøgt, men kun begrænsede data om virkning og sikkerhed er tilgængelige. 
Topotecan was also evaluated in the paediatric population; however, only limited data on efficacy and safety are available.
• Gravide medarbejdere må ikke arbejde med dette lægemiddel. 
• Pregnant staff should be excluded from working with this medicinal product.
Alvorlig overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne. 
Severe hypersensitivity to the active substance or to any of the excipients.
Hvid polyvinylchlorid / polychlorotrifluoroethylen-blister forseglet med aluminium / polyethylenterephtalat (PET) / papir-folie. 
White polyvinyl chloride / polychlorotrifluoroethylene blister sealed with aluminium / Polyethylenterephtalate (PET) / paper foil lidding.
Pancytopeni 
Pancytopenia
Alvorlig neutropeni varede længere end syv dage i 11 % af alle serierne. 
Severe neutropenia lasted beyond seven days in 11% of courses overall.
Prækliniske studier tyder på, at topotecans plasmaproteinbinding er lav (35 %), og fordelingen mellem blodceller og plasma er omtrent homogen. 
Preclinical studies indicate plasma protein binding of topotecan is low (35%) and distribution between blood cells and plasma was fairly homogeneous.
HYCAMTIN kapsler kan tages med eller uden mad (se pkt. 
Hycamtin capsules may be taken with or without food (see section 5.2).
Diarré pga. cancerbehandling forbindes med signifikant morbiditet og kan være livstruende. 
Cancer treatment-induced diarrhoea (CTID) is associated with significant morbidity and may be life-threatening.
• Uforvarende berøring med hud eller øjne skal omgående behandles med rigelige mængder vand. 
• Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Ovariecancer og småcellet lungecancer Første dosis 
Ovarian and small cell lung carcinoma Initial dose
Opbevaringsforhold efter rekonstitution og fortynding af lægemidlet, se pkt. 
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Farmakokinetikken for topotecan var generelt uændret, når det blev givet sammen med ranitidin. 
The pharmacokinetics of topotecan were generally unchanged when co-administered with ranitidine.
Under serie 1 var forekomsten 20 %, under serie4 var forekomsten 8 %. 
In course 1 the incidence was 20%, by course 4 the incidence was 8%.
Standard onkologisk praksis for behandling af neutropeni er enten at administrere topotecan sammen med andre lægemidler (f.eks. G-CSF), eller at reducere dosis for at opretholde neutrofiltallet. 
Standard oncology practice for the management of neutropenia is either to administer topotecan with other medicinal products (e.g. G-CSF) or to reduce the dose to maintain neutrophil counts.
• Aktivt stof: topotecan. 
• The active substance is topotecan.
Husk at fortælle lægen, hvis du starter med at tage anden medicin under behandlingen med Hycamtin. 
Remember to tell your doctor if you start to take any other medicines while you are on Hycamtin.
Hos patienter, der var refraktære eller som fik tilbagefald inden for 3 måneder efter cisplatinbehandling (n = 186), var responsraten 10 %. 
In patients refractory to or relapsing within 3 months after cisplatin therapy (n = 186), the response rate was 10%.
Intravenøs topotecan skal overvejes i følgende kliniske situationer: ukontrolleret emesis, synkeforstyrrelser, ukontrolleret diarré, kliniske tilstande og medicinering, som kan ændre den gastrointestinale motilitet og lægemiddelabsorption. 
Intravenous topotecan should be considered in the following clinical situations: uncontrolled emesis, swallowing disorders, uncontrolled diarrhoea, clinical conditions and medication that may alter gastrointestinal motility and drug absorption.
Kontakt lægen hvis du får noget i øjet eller oplever en forandring i huden. 
Consult your doctor after eye contact or if you experience a skin reaction.
Topotecan skal rekonstitueres og fortyndes yderligere inden anvendelse (se pkt. 
Topotecan must be reconstituted and further diluted before use (see section 6.6).
Dette bør overvejes, når HYCAMTIN ordineres f.eks. i tilfælde, hvor det overvejes at behandle patienter med øget risiko for tumorblødning. 
This should be taken into account when prescribing HYCAMTIN, e.g. if patients at increased risk of tumour bleeds are considered for therapy.