FrancophonIA/ELRC3.0 huggingface dataset:
English: Paediatric clinical study in relapsed or refractory T-ALL and T-LBL In an open-label, multicenter study carried out by Childrens Oncology Group, nelarabine was administered intravenously over 1 hour for 5 days to 151 patients ≤ 21 years of age, 149 of whom had relapsed or refractory T-cell acute lymphoblastic leukaemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL).
Danish: Pædiatrisk klinisk studie med recidiverende eller refraktær T-ALL og T-LBL I et åbent multicenterstudie udført af Childrens Oncology Group, blev nelarabin givet intravenøst over 1 time i 5 dage til 151 patienter ≤ 21 år, hvoraf 149 havde fået recidiv eller havde refraktær T-celle akut lymfoblastær leukæmi (T-ALL) eller T-celle lymfoblastær lymfom (T-LBL).
English: Data from NCI studies/compassionate use programme and phase I studies
Danish: Data fra studierne fra National Cancer Institute/programmet for udleveringstilladelse og fase I-studier
English: - Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Danish: - Ved uforvarende kontakt med hud eller øjne skal området omgående skylles med rigelige mængder vand.
English: Respiratory, thoracic and mediastinal disorders Pleural effusion
Danish: Luftveje, thorax og mediastinum Pleural effusion
English: 5 every 21 days, 2 patients developed a significant grade 3 ascending sensory neuropathy.
Danish: Ved en dosis på 2.200 mg/m givet på dag 1, 3 og 5 hver 21. dag, udviklede 2 patienter en signifikant grad 3 ascenderende sensorisk neuropati.
English: (25 %) in adult and paediatric patients, respectively.
Danish: (25 %) for voksne og pædiatriske patienter.
English: Symptoms may be mental (e.g. tiredness) or physical (e.g. convulsions, feelings of numbness or tingling, weakness and paralysis).
Danish: Symptomer kan være mentale (fx træthed) eller fysiske (fx kramper, en sovende eller prikkende fornemmelse, svaghed og lammelse).
English: Initial symptoms including nausea and vomiting, shortness of breath, an irregular heartbeat, clouding of urine, lethargy and/or joint discomfort.
Danish: De første symptomer omfatter kvalme og opkastning, åndenød, uregelmæssigt hjerteslag, uklar urin, sløvhed og/eller ledproblemer.
English: Excipients: Sodium chloride, water for injections, hydrochloric acid, sodium hydroxide.
Danish: Hjælpestoffer: Natriumchlorid, vand til injektionsvæsker, saltsyre, natriumhydroxid.
English: • if you (or your child, if he/she is being treated) have any kidney or liver problems.
Danish: • hvis du/dit barn (hvis det er dit barn, der bliver behandlet) har nyre- eller leverproblemer.
English: Each ml of solution contains 1.725 mg (75 micromols) of sodium.
Danish: 1 ml infusionsvæske indeholder 1,725 mg (75 mikromol) natrium.
English: Breast-feeding should be discontinued during treatment with Atriance.
Danish: Amning skal ophøre under behandling med Atriance.
English: Cleft palate was seen in rabbits given a dose approximately 2-fold the adult human dose, absent pollices in rabbits given a dose approximately 79 % of the adult human dose while absent gall bladder, accessory lung lobes, fused or extra sternebrae and delayed ossification was seen at all doses.
Danish: 2 gange human voksendosis, manglende pollex hos kaniner efter en dosis på ca. 79 % af humane voksendosis, mens manglende galdeblære, accessoriske lungelapper, sammensmeltede eller ekstra sternebrae og forsinket knogledannelse blev set for alle doser.
English: Age has no effect on the pharmacokinetics of nelarabine or ara-G.
Danish: Alder har ingen indvirkning på farmakokinetikken for nelarabin eller ara-G.
English: Concomitant administration of nelarabine in combination with adenosine deaminase inhibitors such as pentostatin is not recommended.
Danish: Samtidig administration af nelarabin og adenosindeaminasehæmmere, så som pentostatin frarådes.
English: Very common: 32 (38%)
Danish: Meget almindelig: 32 (38 %)
English: Other medicines and Atriance
Danish: Brug af anden medicin sammen med Atriance
English: No data are available to provide a dose advice for patients with Clcr less than 50 ml/min.
Danish: Der findes ingen data til støtte for dosisvejledning til patienter med clearance mindre end 50 ml/min.
English: In 28 adult patients, 24 hours after nelarabine infusion on day 1, mean urinary excretion of nelarabine and ara-G was 5.3 % and 23.2 % of the administered dose, respectively.
Danish: 24 timer efter nelarabin infusion på dag 1 var den gennemsnitlige urinudskillelse af nelarabin og ara G hos 28 voksne patienter hhv. 5,3 % og 23,2 % af den administrerede dosis.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/ og på Lægemiddelstyrelsens hjemmeside http://laegemiddelstyrelsen.dk.
English: The pharmacokinetics of nelarabine and ara-G have not been specifically studied in renally impaired or haemodialysed patients.
Danish: Farmakokinetikken af nelarabin og ara-G er ikke undersøgt specifikt hos patienter med nedsat nyrefunktion eller hos patienter i hæmodialyse.
English: Very common: 9 (11%)
Danish: Meget almindelig: 9 (11 %)
English: low potassium levels may cause a feeling of weakness low glucose levels, which may cause nausea, sweating, weakness, faintness, confusion or hallucinations.
Danish: lavt sukkerindhold, som kan forårsage kvalme, svedtendens, svaghed, besvimelse, forvirringstilstand eller hallucinationer.
English: Guanine is N-deaminated to form xanthine, which is further oxidized to yield uric acid.
Danish: Guanin N-deamineres og danner xantin, som yderligere oxideres for at give urinsyre.
English: Clinical studies of nelarabine did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
Danish: Antallet af patienter, som er 65 år eller ældre i de kliniske studier med nelarabin er ikke tilstrækkeligt til at kunne fastslå, om de responderer anderledes end yngre patienter.
English: These may affect more than 1 in 10 people treated with Atriance.
Danish: Disse kan forekomme hos flere end 1 ud af 10 patienter, som bliver behandlet med Atriance.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Tumour lysis syndrome (see also data from compassionate use programme and nonpivotal studies)
Danish: cyster og polypper) Tumor-lysis-syndrom (se også data fra programmet for udleveringstilladelse og fra de ikke pivotale-studier)
English: The principal route of metabolism for nelarabine is O-demethylation by adenosine deaminase to form ara-G, which undergoes hydrolysis to form guanine.
Danish: Den primære metabolisering af nelarabin er O-demethylering vha. adenosindeaminase til dannelse af ara-G, som undergår hydrolyse og danner guanin.
English: • Shortness of breath, difficult or laboured breathing; cough.
Danish: • Åndenød, vanskelig eller besværet vejrtrækning (åndedrætsbesvær); hoste.
English: Very common: 89 (86%) Very common: 74 (88%)
Danish: Meget almindelig: 89 (86 %) Meget almindelig: 74 (88 %)
English: Children and adolescents (aged 21 years and younger) The recommended dose is 650 mg/m of body surface area per day.
Danish: Børn og unge (21 år og yngre) Den anbefalede dosis er 650 mg/m af kroppens overfladeareal pr. dag.
English: There have also been reports of reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré Syndrome.
Danish: Der er rapporter om bivirkninger associeret med demyelinisering og ascenderende perifere neuropatier, der ligner Guillain-Barré syndrom.
English: • Weight loss and loss of appetite (anorexia); stomach pains; sore mouth, mouth ulcers or inflammation.
Danish: • Vægttab og manglende appetit (anoreksi); mavesmerter, ondt i munden pga. sår og betændelse.
English: A blood test will be taken to check possible reduction of white blood cells.
Danish: Der tages en blodprøve, der viser, om antallet af hvide blodceller er faldet.
English: Neoplasms benign and malignant (including cysts and polyps) Tumour lysis syndrome - 7 cases (see sections 4.2 and 4.4)
Danish: cyster og polypper) Tumor-lysis-syndrom - 7 tilfælde (se pkt.
English: Very common: 83 (81%) Very common: 79 (94%)
Danish: Meget almindelig: 83 (81 %) Meget almindelig: 79 (94 %)
English: • Build up of fluid around the lungs leading to chest pain and difficulty in breathing (pleural effusion); wheezing
Danish: • Væskeophobning ved lungerne, der fører til brystsmerter og vejrtrækningsbesvær (pleural effusion); pibende åndedræt.
English: This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.
Danish: Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for lægemidlet, fordi det drejer sig om en sjælden sygdom.
English: Infections and infestations Infection (including but not limited to; sepsis, bacteraemia, pneumonia, fungal infection)
Danish: men ikke begænset til; sepsis, bakteriæmi, pneumoni, svampeinfektion)
English: There have been reports of events associated with demyelination and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome.
Danish: Der er rapporteret om bivirkninger associeret med demyelinisering og om ascenderende perifer neuropati, der ligner Guillain-Barré syndrom (se pkt.
English: Neurotoxicity is the dose-limiting toxicity associated with nelarabine therapy (see section 4.4).
Danish: Neurotoksicitet er den dosisbegrænsende toksicitet i forbindelse med nelarabin-behandling (se pkt.
English: Each ml of Atriance solution for infusion contains 5 mg of nelarabine.
Danish: 1 ml Atriance opløsning til infusion indeholder 5 mg nelarabin.
English: Adults and adolescents (aged 16 years and older) The recommended dose of nelarabine for adults and adolescents aged 16 years and older is 1,500 mg/m administered intravenously over two hours on days 1, 3 and 5 and repeated every
Danish: Voksne og unge (16 år og ældre) Den anbefalede dosis nelarabin til voksne og unge i alderen 16 år og ældre er 1.500 mg/m indgivet intravenøst over 2 timer på dag 1, 3 og 5 og gentaget hver 21. dag.
English: Atriance 5 mg/ml solution for infusion
Danish: Atriance 5 mg/ml infusionsvæske, opløsning.
English: It is likely that nelarabine overdose would result in severe neurotoxicity (possibly including paralysis, coma), myelosuppression and potentially death.
Danish: Det er sandsynligt, at en overdosis af nelarabin vil resultere i svær neurotoksicitet (muligvis inkl.
English: Each vial contains 50 ml.
Danish: Hvert hætteglas indeholder 50 ml.
English: What you need to know before you are given Atriance
Danish: Det skal du vide, før du begynder at bruge Atriance
English: Paediatric patients After infusion of 400 or 650 mg/m nelarabine over one hour in 6 paediatric patients, mean (%CV) plasma nelarabine Cmax and AUCinf values, adjusted to a 650 mg/m dose, were 45.0 µM (40 %) and
Danish: Pædiatriske patienter Efter infusion af 400 eller 650 mg/m nelarabin over 1 time til 6 pædiatriske patienter var middelplasma for nelarabin Cmax og AUCinf, justeret til en 650 mg/m dosis, hhv. 45,0 µmol/l (40 %) og 38,0 µmol/l time (39 %).
English: Mean plasma ara-G Cmax and AUCinf values were 115 µM (16 %) and 571 µM.h (30 %), respectively.
Danish: Middelplasma for ara-G Cmax og AUCinf var hhv. 115 µmol/l (16 %) og 571 µmol/l time (30 %).
English: In addition, some nelarabine is hydrolysed to form methylguanine, which is O-demethylated to form guanine.
Danish: Desuden hydrolyseres noget nelarabin og danner methylguanin, som O-demethyleres og danner guanin.
English: Patients treated previously or concurrently with intrathecal chemotherapy or previously with craniospinal irradiation are potentially at increased risk for neurological adverse events (see section 4.2 - dose modification) and therefore concomitant intrathecal therapy and/or craniospinal irradiation is not recommended.
Danish: Patienter, der tidligere er blevet eller sideløbende bliver behandlet med intratekal kemoterapi eller tidligere har modtaget kraniospinal strålebehandling, har potentielt øget risiko for neurologiske bivirkninger (se pkt.
English: What Atriance contains
Danish: Atriance indeholder:
English: Mean (%CV) intracellular araGTP Cmax and AUC values were 95.6 µM (139 %) and 2214 µM.h (263 %) at this dose.
Danish: Middel intracellulær ara-GTP Cmax og AUC-var 95,6 µmol/l (139 %) og 2.214 µmol/l time (263 %) efter denne dosis.
English: • Low blood levels of some substances: low calcium levels, which may cause muscle cramps, abdominal cramps or spasms low magnesium levels, which may cause muscle weakness, confusion, "jerky" movements, high blood pressure, irregular heart rhythms and decreased reflexes with severely low blood magnesium levels.
Danish: lavt magnesiumindhold, som kan forårsage muskelsvaghed, forvirringstilstand, rykvise bevægelser, højt blodtryk, uregelmæssig hjerterytme samt nedsatte reflekser ved alvorligt lavt magnesiumindhold i blodet.
English: The MAH shall provide yearly updates on any new information concerning the efficacy and safety of the product in patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
Danish: Indehaveren af markedsføringstilladelsen er forpligtet til årligt at levere ny information vedrørende produktets effekt og sikkerhed hos patienter med Tcelle akut lymfoblastær leukæmi (T-ALL) og T-celle lymfoblastær lymfom (T-LBL), hvor sygdommen ikke har responderet på eller er recidiveret efter behandling med mindst to kemoterapiregimer.
English: Mean plasma ara-G Cmax and AUCinf values were 60.1 µM (17 %) and 212 µM.h (18 %), respectively.
Danish: Middelplasma ara-G Cmax og AUCinf var hhv. 60,1 µmol/l (17 %) og 212 µmol/l time (18 %).
English: Very common: 40 (39%) Very common: 13 (15%)
Danish: Meget almindelig: 40 (39 %) Meget almindelig: 13 (15 %)
English: Children and adolescents (aged 21 years and younger) The recommended dose of nelarabine for children and adolescents (aged 21 years and younger) is 650 mg/m administered intravenously over one hour daily for 5 consecutive days, repeated every
Danish: Børn og unge (21 år og yngre) Den anbefalede dosis nelarabin til børn og unge (21 år og yngre) er 650 mg/m indgivet intravenøst over 1 time daglig i 5 på hinanden følgende dage og gentaget hver 21. dag.
English: Hepatobiliary disorders Hyperbilirubinaemia
Danish: Lever og galdeveje Hyperbilirubinæmi
English: Very common: 10(12%)
Danish: Meget almindelig: 10 (12 %)
English: Atriance is stable for up to 8 hours at up to 30°C once the vial is opened.
Danish: Atriance er stabil i op til 8 timer ved temperaturer op til 30 °C efter anbrud af hætteglas.
English: Very common: 51 (50%) Common: 1 (1%)
Danish: Meget almindelig: 51 (50 %) Almindelig: 1 (1 %)
English: Breast-feeding must be discontinued while you are taking Atriance.
Danish: Amning skal ophøre, mens du er i behandling med Atriance.
English: • Feeling drowsy and sleepy; headache; dizziness.
Danish: • En følelse af slaphed og træthed; hovedpine; svimmelhed.
English: Most serious side effects
Danish: Alvorlige bivirkninger
English: Hypoesthesia
Danish: Hypoæstesi
English: These may affect up to 1 in 1,000 people treated with Atriance
Danish: Disse kan forekomme hos op til 1 ud af 1.000 patienter, som bliver behandlet med Atriance:
English: Very common: 42 (41%) Common: 2 (2%)
Danish: Meget almindelig: 42 (41 %) Almindelig: 2 (2 %)
English: Stable for up to 8 hours at up to 30ºC once the vial is opened.
Danish: Stabil i op til 8 timer ved temperaturer op til 30 °C efter anbrud af hætteglas.
English: • if you (or your child, if he/she is being treated) have any blood problems (for example anaemia).
Danish: • hvis du/dit barn (hvis det er dit barn, der bliver behandlet) har nogen blodsygdomme (fx anæmi).
English: Storage of Atriance solution for infusion
Danish: Opbevaring af Atriance infusionsvæske, opløsning
English: Nelarabine has not been studied in individuals with renal impairment.
Danish: Nelarabin er ikke undersøgt hos personer med nedsat leverfunktion.
English: Each ml contains 5 mg of nelarabine.
Danish: 1 ml indeholder 5 mg nelarabin.
English: Very common: 18 (17%) Common: 5 (6%)
Danish: Meget almindelig: 18 (17 %) Almindelig: 5 (6 %)
English: Twenty-eight of the 39 adults had relapsed or were refractory to at least two prior induction regimens and aged between 16 to 65 years of age (mean 34 years).
Danish: 28 ud af de 39 voksne, i alderen 16 til 65 år (i gennemsnit 34 år), var recidiverede eller refraktære i mindst to tidligere induktionsregimer.
English: Very common: 15 (15%) Common: 3 (4%)
Danish: Meget almindelig: 15 (15 %) Almindelig: 3 (4 %)
English: How to store Atriance
Danish: Sådan skal du bruge Atriance
English: Very common: 15 (15%) Very common: 14 (17%)
Danish: Meget almindelig: 15 (15 %) Meget almindelig: 14 (17 %)
English: Very common: 26 (25%) N/A
Danish: Meget almindelig: 26 (25 %) Ikke tilgængelig
English: These may affect up to 1 in 10 people treated with Atriance:
Danish: Disse kan forekomme hos mellem 1 og 10 ud af 100 patienter, som bliver behandlet med Atriance:
English: Very common: 12 (12%) Common: 1 (1%)
Danish: Meget almindelig: 12 (12 %) Almindelig: 1 (1 %)
English: Gastrointestinal disorders Diarrhoea
Danish: Mave-tarmkanalen Diarré
English: Gender has no effect on nelarabine or ara-G plasma pharmacokinetics.
Danish: Køn har ingen indflydelse på farmakokinetikken af nelarabin og ara-G i plasma.
English: 6 x 50 ml vials
Danish: 6 x 50 ml hætteglas
English: 2.6 l/h/m
Danish: 10,8 l/time/m
English: • Feeling of an upset stomach (nausea); being sick/throwing up (vomiting); diarrhoea; constipation
Danish: • Følelse af utilpashed i maven (kvalme); sygdomsfornemmelse (opkastning); diarré, forstoppelse.
English: 1 x 50 ml vial
Danish: 1 x 50 ml hætteglas
English: Each vial contains 50 ml of solution.
Danish: Hvert hætteglas indeholder 50 ml opløsning.
English: Musculoskeletal and connective tissue disorders Muscle weakness
Danish: Knogler, led, muskler og bindevæv Muskelsvaghed
English: • the results of blood tests carried out before treatment Adults and adolescents (aged 16 years and older) The usual dose is 1,500 mg/m of body surface area per day.
Danish: Voksne og unge (16 år og ældre) Den sædvanlige dosis er 1.500 mg/m af kroppens overfladeareal pr. dag.
English: Very common: 22 (21%) Very common: 10 (12%)
Danish: Meget almindelig: 22 (21 %) Meget almindelig: 10 (12 %)
English: Each vial contains 250 mg of nelarabine.
Danish: Et hætteglas indeholder 250 mg nelarabin.
English: Very common: 24 (23%) Common: 6 (7%)
Danish: Meget almindelig: 24 (23 %) Almindelig: 6 (7 %)
English: Very common: 22 (21%) Common: 1 (1%)
Danish: Meget almindelig: 22 (21 %) Almindelig: 1 (1 %)
English: What Atriance looks like and contents of the pack Atriance solution for infusion is a clear, colourless solution.
Danish: Atriance infusionsvæske, opløsning er en klar, farveløs opløsning.
English: What Atriance is and what it is used for What you need to know before you are given Atriance How Atriance is given
Danish: Det skal du vide, før du begynder at bruge Atriance Sådan skal du bruge Atriance Bivirkninger
English: Your doctor also needs to know the following before you are given this medicine:
Danish: Før du begynder at få denne medicin, skal du fortælle det til lægen:
English: (%CV) VSS values were 115 l/m
Danish: Specifikt for nelarabin var middel VSS hhv. 115 l/m
English: These reactions have included altered mental states including severe somnolence, confusion and coma, central nervous system effects including convulsions, ataxia and status epilepticus, and peripheral neuropathy including hypoesthesia ranging from numbness and paresthesias to motor weakness and paralysis.
Danish: Disse bivirkninger inkluderer: ændret mental tilstand herunder svær døsighed, konfusion og koma, påvirkning af centralnervesystemet inkl.
English: Very common: 23 (22%) Common: 8 (10%)
Danish: Meget almindelig: 23 (22 %) Almindelig: 8 (10 %)
English: Novartis Bulgaria EOOD Тел: +359 2 489 98 28
Danish: Тел: +359 2 489 98 28
English: Combined Phase 1 pharmacokinetic data at nelarabine doses of 104 to 2,900 mg/m indicate that mean
Danish: Kombineret fase I farmakokinetiske data ved nelarabindoser på 104 - 2.900 mg/m tyder på, at middel clearance-værdier for nelarabin er hhv. 138 l/time/m
English: Supportive care consistent with good clinical practice should be provided.
Danish: Der bør gives støttende behandling iht.
English: Therefore, close monitoring for neurological reactions is strongly recommended, and nelarabine must be discontinued at the first sign of neurological reactions of NCI CTCAE Grade 2 or greater.
Danish: Nelarabin skal seponeres ved første tegn på neurologiske bivirkninger af NCI Common Toxicity Criteria grad 2 eller derover.
English: Very common: 13 (13%) N/A
Danish: Meget almindelig: 13 (13 %) Ikke tilgængelig
English: Talk to your doctor for advice on how to minimize the risk of bleeding.
Danish: hvordan risikoen for blødning kan mindskes.
English: Complete blood counts including platelets must be monitored regularly (see sections 4.4 and 4.8).
Danish: trombocytter skal monitoreres regelmæssigt (se pkt.
English: Plasma ara-G Cmax values generally occurred at the end of the nelarabine infusion and were generally higher than nelarabine Cmax values, suggesting rapid and extensive conversion of nelarabine to ara-G. After infusion of 1,500 mg/m nelarabine over two hours in adult patients, mean (%CV) plasma nelarabine Cmax and AUCinf values were 13.9 µM (81 %) and 13.5 µM.h (56 %) respectively.
Danish: Efter infusion af 1.500 mg/m nelarabin over 2 timer til voksne patienter, var middelplasma for nelarabin Cmax og AUCinf hhv 13,9 µmol/l (81 %) og 13,5 µmol/l time (56 %).
English: Hepatic impairment
Danish: Pibende åndedræt
English: Very common: 24 (23%) Common: 2 (2%)
Danish: Meget almindelig: 24 (23 %) Almindelig: 2 (2 %)
English: Gait abnormal
Danish: Abnormal gangart
English: Very common: 11 (11%) N/A
Danish: Meget almindelig: 11 (11 %) Ikke tilgængelig
English: Very common: 23 (22%) Common: 2 (2%)
Danish: Meget almindelig: 23 (22 %) Almindelig: 2 (2 %)
English: Rare: N/A
Danish: Sjælden: Ikke tilgængelig Sjælden: Ikke tilgængelig
English: Leukopenia, thrombocytopenia, anaemia, and neutropenia, (including febrile neutropenia) have been associated with nelarabine therapy.
Danish: Leukopeni, trombocytopeni, anæmi og neutropeni (inkl.
English: Nervous system disorders Seizures (including convulsions, grand mal convulsions, status epilepticus)
Danish: kramper, grand mal kramper, status epilepticus)
English: Eye disorders Blurred vision
Danish: Øjne Sløret syn
English: Very common: 15 (15%) N/A
Danish: Meget almindelig: 15 (15 %) Ikke tilgængelig
English: Very common: 21 (20%) N/A
Danish: Meget almindelig: 21 (20 %) Ikke tilgængelig
English: Yearly
Danish: nelarabin
English: Very common: 22 (21%) N/A
Danish: Meget almindelig: 22 (21 %) Ikke tilgængelig
English: This includes any herbal products or medicines you have bought without a prescription
Danish: Dette gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler.
English: Consideration to appropriate birth control is recommended to be discussed with your doctor.
Danish: Tal med lægen om hensigtsmæssig svangerskabsforebyggelse og prævention.
English: Tumour size ≤ 2 cm >2 cm
Danish: Tumorstørrelse 2 cm >2 cm
English: Menopausal status Pre-Menopausal Post-Menopausal
Danish: Menopausal status Præ-menopausal Post-menopausal
English: Consideration should be given to possible effects on the central nervous system.
Danish: Mulige påvirkninger af centralnervesystemet bør tages i betragtning.
English: Such information will allow your doctor to decide whether a dose reduction is needed.
Danish: Denne information vil give lægen mulighed for at vurdere om en nedsættelse af dosis er nødvendig.
English: • low blood pressure.
Danish: • lavt blodtryk
English: North Harrow, Middlesex HA1 4HF United Kingdom
Danish: North Harrow, Middlesex HA1 4HF Storbritannien