FrancophonIA/ELRC3.0 huggingface dataset:
English: Median time to onset of moderate to severe anaemia was day 12 with a median duration of 7 days.
Danish: Mediantiden til indtræden af moderat til alvorlig anæmi var dag 12 med en medianvarighed på 7 dage.
English: The mean metabolite:parent AUC ratio was <10% for both total topotecan and topotecan lactone.
Danish: Det gennemsnitlige forhold mellem hovedmetabolitten og lægemiddelstoffets AUC var < 10 % for såvel topotecan som topotecanlakton.
English: If reconstitution and dilution is performed under strict aseptic conditions (e.g. an LAF bench) the product should be used (infusion completed) within 12 hours at room temperature or 24 hours if stored at 2-8
Danish: Hvis opløsning og fortynding udføres under strikt aseptisk teknik (f.eks. i LAFbænk), skal produktet anvendes (infusion afsluttes) inden for 12 timer ved opbevaring ved stuetemperatur eller inden for 24timer, hvis det opbevares ved 2-8
English: The contents of HYCAMTIN 4 mg vials must be reconstituted with 4 ml water for injections.
Danish: Indholdet af HYCAMTIN 4 mg hætteglas skal rekonstitueres med 4 ml vand til injektionsvæske.
English: Thrombocytopenia Severe thrombocytopenia (Grade 4 - platelets <10 x 10
Danish: Trombocytopeni Alvorlig trombocytopeni (grad 4 - trombocyttal < 10 x 10
English: Hycamtin capsules must not be opened or crushed.
Danish: Hycamtin kapsler må ikke åbnes eller knuses.
English: The total content of active substance in the vial provides 1 mg per ml of active substance when reconstituted as recommended.
Danish: Det totale indhold af aktivt lægemiddelstof i hætteglasset giver 1 mg pr. ml aktivt lægemiddelstof, når det rekonstitueres som anbefalet.
English: ITT population Cisplatin 50 mg/m on day 1, every 21 days
Danish: ITT-population cisplatin 50 mg/m på dag 1, hver 21. dag cisplatin 50 mg/m på dag 1 + topotecan
English: If reconstitution and dilution are performed under strict aseptic conditions (e.g. an LAF bench) the product should be used (infusion completed) within 24 hours if stored at 2ºC - 8ºC after the first puncture of the vial.
Danish: Hvis rekonstitution og fortynding udføres under strenge aseptiske forhold (fx i en LAF-bænk), skal lægemidlet anvendes (infusion fuldført) inden for 24 timer, hvis lægemidlet opbevares ved 2 °C - 8 °C efter den første åbning.
English: Geometric mean topotecan lactone dose-normalised AUC(0-) values were 9.4, 11.1 and 12.0 ng*h/ml in subjects with creatinine clearance values of more than 80 ml/min, 50 to 80 ml/min and 30 to 49 ml/min, respectively.
Danish: Det geometriske gennemsnit af topotecanlacton dosisnormaliseret AUC(0-∞) var hhv. 9,4; 11,1 og 12,0 ng∙time/ml hos patienter med kreatinin-clearance over 80 ml/min, 50-80 ml/min og 30-49 ml/min.
English: 9/l) occurred in 6% of patients in 2% of courses.
Danish: 9/l) sås hos 6 % af patienterne i 2 % af serierne.
English: Growth factors were administered to 19% of patients in 8% of courses.
Danish: Der blev givet vækstfaktorer til 19 % af patienterne i 8 % af serierne (se pkt.
English: The capsule(s) must be swallowed whole, and must not be chewed crushed or divided.
Danish: Kapslen/kapslerne skal synkes hele og må ikke tygges, knuses eller deles.
English: • Ovarian and small cell lung cancer: 1.5 mg per square metre of body surface area per day.
Danish: Den sædvanlige dosis er • Ovariecancer eller småcellet lungecancer: 1,5 mg/m af kroppens overfladeareal pr. dag.
English: Geometric mean topotecan lactone dose-normalised AUC(0-) values for Korean patients were 7.9, 12.9 and 19.7 ng*h/ml in subjects with creatinine clearance values of more than 80 ml/min, 50 to 80 ml/min and 30 to 49 ml/min, respectively (see section 4.2 and 4.4).
Danish: Topotecanlacton dosis-normaliseret AUC(0-∞) for koreanske patienter var hhv. 7,9; 12,9 og 19,7 ng∙time/ml hos patienter med kreatinin-clearance over 80 ml/min, 50-80 ml/min og 30-49 ml/min (se pkt.
English: This rare side effect may affect up to 1 in 1,000 people treated with Hycamtin:
Danish: Denne sjældne bivirkning kan forekomme hos op til 1 ud af 1.000 personer, der får Hycamtin:
English: Median time to onset of severe neutropenia was day 12 with a median duration of 7 days.
Danish: Mediantiden til indtræden af alvorlig neutropeni var dag 12 med en medianvarighed på 7 dage.
English: The contents of HYCAMTIN 1 mg vials must be reconstituted with 1.1 ml water for injections.
Danish: Indholdet af HYCAMTIN 1 mg hætteglas skal rekonstitueres med 1,1 ml vand til injektionsvæske.
English: Patients with renal impairment
Danish: Patienter med nedsat nyrefunktion
English: What you need to know before you take Hycamtin
Danish: Det skal du vide, før du begynder at tage Hycamtin
English: Relapsed ovarian cancer
Danish: Recidiverende ovariecancer
English: The recommended monotherapy dose of oral topotecan in patients with small cell lung carcinoma with creatinine clearance between 30 and 49 ml/min is 1.9 mg/m2/day for five consecutive days.
Danish: Den anbefalede orale dosis af topotecan som monoterapi hos patienter med småcellet lungecancer og kreatinin-clearance mellem 30 og 49 ml/min er 1,9 mg/m2/dag i fem på hinanden følgende dage.
English: Reconstitution
Danish: Rekonstitution
English: Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Danish: Hvis man ved et uheld får medikamentet på huden eller i øjnene, skal der straks skylles med rigelige mængder vand.
English: Each capsule contains topotecan hydrochloride equivalent to 0.25 mg of topotecan.
Danish: Hver kapsel indeholder topotecanhydrochlorid svarende til 0,25 mg topotecan.
English: In clinical studies involving patients with relapsed small cell lung cancer, the dose-limiting toxicity of oral topotecan monotherapy was found to be haematological.
Danish: I kliniske studier af monoterapi med oral topotecan til patienter med recidiverende småcellet lungecancer var den dosisbegrænsende toksicitet hæmatologisk.
English: Neutropenia Severe (neutrophil count <0.5 x 10
Danish: Neutropeni Alvorlig neutropeni (neutrofiltal < 0,5 x 10
English: The pharmacokinetics of oral topotecan have not been studied in patients with hepatic impairment (see section 4.2 and 4.4).
Danish: Farmakokinetikken for oral topotecan er ikke undersøgt hos patienter med nedsat leverfunktion (se pkt.
English: Tartaric acid (E334) Mannitol (E421) Hydrochloric acid (E507) Sodium hydroxide
Danish: Vinsyre (E334) Mannitol (E421) Saltsyre (E507) Natriumhydroxid
English: Thrombocytopenia Severe (platelets <25 x 10
Danish: Trombocytopeni Alvorlig trombocytopeni (trombocyttal < 25 x 10
English: HYCAMTIN 1 mg hard capsules
Danish: HYCAMTIN 1 mg hårde kapsler
English: 9/l) for seven days or more or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 0.25 mg/m 2/day to
Danish: 9/l) i syv dage eller mere, eller alvorlig neutropeni forbundet med feber eller infektion, eller hvis behandling er blevet udskudt på grund af neutropeni, bør dosis reduceres med 0,25 mg/m 2/dag til 1,25 mg/m 2/dag
English: • If you have any further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: 9/l) occurred in 29% of patients in 14% of courses.
Danish: 9/l) sås hos 29 % af patienterne i 14 % af serierne.
English: What Hycamtin looks like and contents of the pack Hycamtin 0.25 mg capsules are white to yellowish white and imprinted with “Hycamtin” and “0.25 mg”.
Danish: Hycamtin 0,25 mg kapsler er hvide til gulligt hvide og præget med “Hycamtin” og “0.25 mg”.
English: Titanium dioxide (E171) Red iron oxide (E172)
Danish: Titandioxid (E171) Jernoxid, rød (E172)
English: Severe bleeding (associated with thrombocytopenia) Immune system disorders Common
Danish: Alvorlig blødning (associeret med trombocytopeni)
English: The powder in the vial provides 1 mg per ml of active substance when reconstituted as recommended.
Danish: Pulveret i hætteglasset giver 1 mg aktivt stof pr. ml, såfremt det fortyndes som anbefalet.
English: There is insufficient experience with the use of topotecan in patients with severely impaired hepatic function (serum bilirubin 10 mg/dl) due to cirrhosis.
Danish: Der er utilstrækkelig erfaring med brugen af topotecan hos patienter med alvorlig nedsat leverfunktion (serum bilirubin 10 mg/dl) på grund af cirrose.
English: HYCAMTIN 4 mg is available in packs containing 1 vial and 5 vials.
Danish: HYCAMTIN 4 mg kan leveres i pakninger indeholdende 1 hætteglas og 5 hætteglas.
English: General disorders and administration site conditions Very common Fatigue Common
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig Træthed
English: Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4).
Danish: Dødsfald på grund af sepsis er rapporteret for patienter i behandling med topotecan (se pkt.
English: OUTER CARTON
Danish: YDRE ÆSKE
English: What Hycamtin contains
Danish: Hycamtin indeholder:
English: Topotecan has been shown to cause embryo-foetal lethality and malformations in preclinical studies (see section 5.3).
Danish: Prækliniske studier har vist, at topotecan medfører embryo/fosterdødelighed og misdannelser (se pkt.
English: HYCAMTIN 1 mg powder for concentrate for solution for infusion Each vial contains 1 mg topotecan (as hydrochloride).
Danish: HYCAMTIN 1 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 1 mg topotecan (som hydrochlorid).
English: HYCAMTIN 4 mg powder for concentrate for solution for infusion Each vial contains 4 mg topotecan (as hydrochloride).
Danish: HYCAMTIN 4 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 4 mg topotecan (som hydrochlorid).
English: HYCAMTIN 1 mg is available in packs containing 1 vial and 5 vials.
Danish: HYCAMTIN 1 mg kan leveres i pakninger indeholdende 1 hætteglas og 5 hætteglas.
English: Hycamtin 1 mg powder for concentrate for solution for infusion should be reconstituted with 1.1 ml of water for injections to provide 1 mg per ml of topotecan.
Danish: Hycamtin 1 mg pulver til koncentrat til infusionsvæske, opløsning skal rekonstitueres med 1,1 ml vand til injektionsvæsker for at få 1 mg pr. ml topotecan.
English: For severe cases (CTC Grade 3/4) reported as related/possibly related to topotecan administration the incidence was diarrhoea 5% (see section 4.4), fatigue 4%, vomiting 3%, nausea 3% and anorexia 2%.
Danish: I alvorlige tilfælde (CTC grad 3/4) rapporteret som relateret/muligvis relateret til administration af topotecan var forekomsten: diarré 5 % (se pkt.
English: HYCAMTIN 0.25 mg hard capsules
Danish: HYCAMTIN 0,25 mg hårde kapsler
English: Anaemia
Danish: Anæmi
English: Hycamtin 4 mg powder for concentrate for solution for infusion should be reconstituted with 4 ml of water for injections to provide 1 mg per ml of topotecan.
Danish: Hycamtin 4 mg pulver til koncentrat til infusionsvæske, opløsning skal rekonstitueres med 4 ml vand til injektionsvæsker for at få 1 mg pr. ml topotecan.
English: There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance <20 ml/min) or severely impaired hepatic function (serum bilirubin 10 mg/dl) due to cirrhosis.
Danish: Der er ikke tilstrækkelig erfaring i brugen af topotecan til patienter med svært nedsat nyrefunktion (kreatinin-clearance < 20 ml/min) eller svært nedsat leverfunktion (serumbilirubin  10 mg/dl) på grund af cirrose.
English: A doctor or a nurse will give you the medicine as an infusion into a vein in hospital.
Danish: Medicinen gives som intravenøs infusion i en vene, på hospitalet af en læge eller en sygeplejerske.
English: • The other ingredients are: tartaric acid (E334), mannitol (E421), hydrochloric acid (E507) and sodium hydroxide.
Danish: • Øvrige indholdsstoffer: vinsyre (E334), mannitol (E421), saltsyre (E507) og natriumhydroxid.
English: 100 x 10
Danish: trombocyttallet er  100 x 10
English: What you need to know before you are given Hycamtin
Danish: Det skal du vide, før du begynder at få Hycamtin
English: Each capsule contains 0.25 mg or 1 mg of topotecan (as hydrochloride).
Danish: Hver kapsel indeholder 0,25 mg eller 1 mg topotecan (som hydrochlorid).
English: Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without GCSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
Danish: På baggrund af den toksiske grænseværdi for myelosuppression blev den maksimalt tolererede dosis (MTD) fastsat til 2,0 mg/m 2/dag med G-CSF og 1,4 mg/m 2/dag uden
English: HYCAMTIN capsules should not be broken or crushed.
Danish: HYCAMTIN kapslerne må ikke deles eller knuses.
English: HYCAMTIN 1 mg hard capsules topotecan
Danish: HYCAMTIN 1 mg hårde kapsler topotecan
English: No effects on male or female fertility have been observed in reproductive toxicity studies in rats (see section 5.3).
Danish: I reproduktionstoksiske studier med rotter er der ikke set påvirkning af fertilitet hos hverken hanner eller hunner (se pkt.
English: Use of topotecan in this group of patients is not recommended (see section 4.4).
Danish: Anvendelse af topotecan i denne gruppe af patienter anbefales ikke (se pkt.
English: Each vial contains 1 mg or 4 mg of topotecan (as hydrochloride).
Danish: Hvert hætteglas indeholder 1 mg eller 4 mg topotecan (som hydrochlorid).
English: Mucosal inflammation Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4).
Danish: Slimhindeinflammation Dødsfald på grund af sepsis er rapporteret for patienter i behandling med topotecan (se pkt.
English: Fatalities due to neutropenic colitis have been reported in clinical studies with topotecan.
Danish: I kliniske studier med topotecan er der set dødsfald på grund af neutropenisk colitis.
English: HYCAMTIN 0.25 mg hard capsules HYCAMTIN 1 mg hard capsules
Danish: HYCAMTIN 0,25 mg hårde kapsler HYCAMTIN 1 mg hårde kapsler
English: There is insufficient experience of the use of topotecan in patients with severely impaired hepatic function (serum bilirubin 10 mg/dl).
Danish: Der er utilstrækkelig erfaring i brugen af topotecan til patienter med svært nedsat leverfunktion (serumbilirubin ≥10 mg/dl).
English: Reports of significant sequelae associated with thrombocytopenia, including fatalities due to tumour bleeds, have been infrequent.
Danish: Signifikante følger af trombocytopeni herunder letal tumorblødning er sjældent rapporteret.
English: Use of topotecan in these patients is not recommended (see section 4.2).
Danish: Anvendelse af topotecan til disse patienter anbefales ikke (se pkt.
English: How to take Hycamtin
Danish: Sådan skal du tage Hycamtin
English: HYCAMTIN 0.25 mg hard capsules topotecan
Danish: HYCAMTIN 0,25 mg hårde kapsler topotecan
English: Each capsule contains 1 mg of topotecan (as hydrochloride).
Danish: En kapsel indeholder 1 mg topotecan (som hydrochlorid).
English: Oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive SCLC in patient selfreports on an unblinded symptom scale assessment in each of these two studies.
Danish: I patienternes egne rapporteringer vha. en ublindet vurdering på en symptomskala i begge studier var oral og intravenøs topotecan forbundet med samme symptomlindring hos patienter med recidiverende, sensitiv SCLC.
English: What Hycamtin looks like and contents of the pack Hycamtin comes as a powder for concentrate for solution for intravenous infusion.
Danish: Hycamtin fås som pulver til koncentrat til opløsning beregnet til intravenøs infusion.
English: Haematological
Danish: Hæmatologisk
English: Also contains: tartaric acid (E334), mannitol (E421), hydrochloric acid (E507), sodium hydroxide.
Danish: Øvrige indholdsstoffer: Vinsyre (E334), mannitol (E421), saltsyre (E507), natriumhydroxid.
English: Check with your doctor or pharmacist if you are not sure.
Danish: • Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: Each capsule contains 0.25 mg of topotecan (as hydrochloride).
Danish: En kapsel indeholder 0,25 mg topotecan (som hydrochlorid).
English: Justification for not including Braille accepted
Danish: Fritaget fra krav om brailleskrift.
English: Powder for concentrate for solution for infusion
Danish: Pulver til koncentrat til infusionsvæske, opløsning
English: Hycamtin 0.25 mg hard capsules Hycamtin 1 mg hard capsules topotecan
Danish: Hycamtin 0,25 mg hårde kapsler Hycamtin 1 mg hårde kapsler topotecan
English: However, there are insufficient data available to make a dose recommendation for this patient group (see section 4.2).
Danish: Der er dog ikke en tilstrækkelig mængde data tilgængelig til at kunne give en anbefaling vedrørende dosering til denne patientgruppe (se pkt.
English: Additional adverse events were seen when topotecan was given in combination with cisplatin; however, these events were seen with cisplatin monotherapy and were not attributable to topotecan.
Danish: Disse bivirkninger er dog tidligere set som følge af behandling med cisplatin-monoterapi og skyldtes ikke topotecan.
English: Powder for concentrate for solution for infusion.
Danish: Pulver til koncentrat til infusionsvæske, opløsning.
English: What Hycamtin is and what it is used for What you need to know before you are given Hycamtin How Hycamtin is used
Danish: Virkning og anvendelse Det skal du vide, før du begynder at tage Hycamtin Sådan skal du tage Hycamtin Bivirkninger Opbevaring Pakningsstørrelser og yderligere oplysninger
English: • Mouth sores, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhoea, bloody stools
Danish: • Kvalme, opkastning, diarré, mavesmerter, forstoppelse.
English: Driving and using machines Hycamtin can make people feel tired.
Danish: Hycamtin kan medføre træthed.
English: Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds have been infrequent.
Danish: Der er kun sjældne rapporter om signifikante følger af trombocytopeni herunder fatal tumorblødning.
English: The elimination of topotecan has only been partly investigated in man. A major route of clearance of topotecan was by hydrolysis of the lactone ring to form the ring-opened carboxylate.
Danish: En vigtig eliminationsvej for topotecan var hydrolyse af laktonringen, så der dannes ringåbnet carboxylat.
English: HYCAMTIN 1 mg powder for concentrate for solution for infusion HYCAMTIN 4 mg powder for concentrate for solution for infusion
Danish: HYCAMTIN 1 mg pulver til koncentrat til infusionsvæske, opløsning HYCAMTIN 4 mg pulver til koncentrat til infusionsvæske, opløsning
English: In reproductive toxicity studies with topotecan in rats there was no effect on male or female fertility; however, in females super-ovulation and slightly increased pre-implantation loss were observed.
Danish: I reproduktionstoksiske studier af topotecan til rotter sås ingen virkning på fertilitet hos hverken hanner eller hunner.
English: These may affect more than 1 in 10 people treated with Hycamtin:
Danish: De kan forekomme hos flere end 1 ud af 10 personer, der får Hycamtin:
English: Plasma clearance in patients with renal impairment (creatinine clearance 41-60 ml/min.)
Danish: Plasmaclearance hos patienter med nedsat nyrefunktion (kreatinin-clearance på 41-60 ml/min) faldt til ca. 67 % sammenlignet med kontrolgruppen.
English: However, there are insufficient data available to make a dose recommendation for this patient group (see section 4.4).
Danish: Der er dog ikke tilstrækkelige data til rådighed til at foretage en dosisanbefaling til denne patientgruppe (se pkt.
English: Hycamtin 1 mg powder for concentrate for solution for infusion Hycamtin 4 mg powder for concentrate for solution for infusion topotecan
Danish: Hycamtin 1 mg pulver til koncentrat til infusionsvæske, opløsning Hycamtin 4 mg pulver til koncentrat til infusionsvæske, opløsning topotecan
English: Medicines should not be disposed of via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: 4 mg vial
Danish: 4 mg hætteglas
English: Topotecan is not recommended to be used in this patient group (see section 4.4).
Danish: Det anbefales ikke at anvende topotecan i denne patientgruppe (se pkt.
English: 9/l) in 25% of patients (8% of courses); moderate (platelets between 25.0 and
Danish: 9/l) hos 25 % af patienterne (8 % af serierne),
English: These may affect up to 1 in 1,000 people treated with Hycamtin:
Danish: De kan forekomme hos op til 1 ud af 1.000 personer, der får Hycamtin:
English: How to store Hycamtin
Danish: Sådan får du Hycamtin
English: These may affect up to 1 in 100 people treated with Hycamtin:
Danish: De kan forekomme hos op til 1 ud af 100 personer, der får Hycamtin:
English: 1 mg vial
Danish: 1 mg hætteglas
English: Very common Nausea, vomiting and diarrhoea (all of which may be severe), constipation,
Danish: Interstitiel lungesygdom (nogle tilfælde har været letale) Mave-tarm-kanalen Meget almindelig Kvalme, opkastning og diarré (alle muligvis alvorlige), forstoppelse, mavesmerter
English: HYCAMTIN 1 mg powder for concentrate for solution for infusion topotecan
Danish: HYCAMTIN 1 mg pulver til koncentrat til infusionsvæske, opløsning topotecan
English: HYCAMTIN 4 mg powder for concentrate for solution for infusion topotecan
Danish: HYCAMTIN 4 mg pulver til koncentrat til infusionsvæske, opløsning topotecan
English: There may be a higher than usual chance of you getting side effects if you are also being treated with cyclosporin A. You will be monitored closely if you are taking both these medicines.
Danish: Hvis du også bliver behandlet med ciclosporin A, kan risikoen for at få bivirkninger være større.
English: 5 x 4 mg vials
Danish: 5 x 4 mg hætteglas
English: Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Danish: Der er rapporteret om myelosuppression, der har ført til sepsis, som igen har ført til dødsfald, efter behandling med topotecan (se pkt.
English: HYCAMTIN 4 mg powder for concentrate for solution for infusion
Danish: HYCAMTIN 4 mg pulver til koncentrat til infusionsvæske, opløsning
English: HYCAMTIN 1 mg powder for concentrate for solution for infusion
Danish: HYCAMTIN 1 mg pulver til koncentrat til infusionsvæske, opløsning
English: 5 x 1 mg vials
Danish: 5 x 1 mg hætteglas
English: 1 x 1 mg vial
Danish: 1 x 1 mg hætteglas
English: • If you get any side effects, talk to your doctor.
Danish: • Kontakt lægen, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: Extravasation
Danish: PRODUKTRESUMÉ
English: These may affect up to 1 in 10 people treated with Hycamtin:
Danish: De kan forekomme hos op til 1 ud af 10 personer, der får Hycamtin:
English: 9/l, the platelet count is
Danish: 9/l ved baseline.
English: 1 x 4 mg vial
Danish: 1 x 4 mg hætteglas
English: Tell your doctor if you are taking, have recently taken, or might take any other medicines, including any herbal products or medicines obtained without a prescription.
Danish: • Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: Breast-feeding (see section 4.6).
Danish: Amning (se pkt.
English: 50.0 x 10
Danish: moderat (trombocyttal mellem 25,0 og 50,0 x 10
English: In patients (n = 39) with recurrence within 180 days after chemoradiotherapy with cisplatin, the median survival in the topotecan plus cisplatin arm was 4.6 months (95% CI: 2.6, 6.1) versus 4.5 months (95% CI: 2.9, 9.6) for the cisplatin arm, with a hazard ratio of 1.15 (0.59, 2.23).
Danish: i gruppen, der fik topotecan + cisplatin (95 % CI: 2,6; 6,1) versus 4,5 mdr.
English: This summary was last updated in April 2017.
Danish: Dette sammendrag blev sidst ajourført i april 2017.
English: The amount of gel given in each dose is adjusted depending on the weight of the animal.
Danish: Mængden af gel i hver dosis tilpasses dyrets vægt.