FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/96/011/001 (1 vial) EU/1/96/011/002 (10 vials)
Danish: EU/1/96/011/001 (1 hætteglas) EU/1/96/011/002 (10 hætteglas)
English: How to use Caelyx
Danish: Sådan skal du bruge Caelyx
English: Pyridoxine (Vitamin B6): - vitamin B6 is available without prescription; - take 50-150 mg daily beginning at the first signs of redness or tingling.
Danish: Pyridoxin (vitamin B6): - vitamin B6 kan fås uden recept.
English: 75,000 - 150,000 Resume treatment with no dose reduction.
Danish: JUSTERING Grad 1 1.500 - 1.900 75.000 - 150.000 Genoptag behandling uden dosisreduktion.
English: 100 out of 929 patients (10.8%) with solid tumours were described as having an infusion-associated reaction during treatment with Caelyx as defined by the following Costart terms: allergic reaction, anaphylactoid reaction, asthma, face oedema, hypotension, vasodilatation, urticaria, back pain, chest pain, chills, fever, hypertension, tachycardia, dyspepsia, nausea, dizziness, dyspnoea, pharyngitis, rash, pruritus, sweating, injection site reaction and medicinal product interaction.
Danish: Hos 100 af 929 patienter (10,8 %) med massive tumorer blev infusionsrelaterede reaktioner beskrevet under behandling med Caelyx, karakteriseret ved følgende Costart termer: allergisk reaktion, anafylaktoid reaktion, astma, ansigtsødem, hypotension, vasodilatation, urticaria, rygsmerter,
English: In a pooled analysis of 4,231 patients receiving Caelyx for breast cancer, ovarian cancer, multiple myeloma, or AIDS-related KS, ventricular arrythmia, palpitations, cardiac failure, cardiac arrest, bundle branch block right, and ejection fraction decreased were reported uncommonly, and atrioventricular block, cyanosis, and conduction disorder were reported rarely.
Danish: I en samlet analyse af 4.231 patienter, som fik Caelyx til behandling af brystcancer, ovariecancer, myelomatose eller AIDS-relateret KS, blev ventrikulær arytmi, palpitationer, hjertesvigt, hjertestop, højresidig grenblok og reduceret uddrivningsfraktion (ejection fraction) rapporteret med hyppigheden ikke almindelig og atrioventrikulært blok, cyanose og ledningsforstyrrelse rapporteret med hyppigheden sjælden.
English: 509 patients with advanced breast cancer who had not received prior chemotherapy for metastatic disease were treated with Caelyx (n=254) at a dose of 50 mg/m2 every 4 weeks, or doxorubicin
Danish: 509 patienter med fremskreden brystcancer, som ikke tidligere havde modtaget kemoterapi for metastaserende sygdom, blev behandlet med Caelyx (n=254) i en dosis på 50 mg/m2 hver 4. uge, eller doxorubicin (n=255) i en dosis på 60 mg/m2 hver 3. uge, i en fase III klinisk undersøgelse (I97-328).
English: Caelyx must not be given by the intramuscular or subcutaneous route (see section 6.6).
Danish: Caelyx må ikke indgives intramuskulært eller subkutant (se pkt.
English: Grade 1 (painless ulcers, erythema, or mild soreness)
Danish: Grad 1 (smertefrie sår, erytem eller let ømhed)
English: Investigations common weight loss
Danish: Undersøgelser almindelig vægttab
English: Excipients: -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)-methoxypoly(oxyethylen)-40 sodium salt, fully hydrogenated soy phosphatidylcholine, cholesterol, ammonium sulphate, sucrose, histidine, water for injections, hydrochloric acid and sodium hydroxide.
Danish: Hjælpestoffer: -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)- methoxypoly(oxyethylen)-40 natriumsalt, helhydrogeneret sojafosfatidylcholin, kolesterol, ammoniumsulfat, saccharose, histidin, vand til injektion, saltsyre og natriumhydroxid.
English: Do not administer Caelyx as a bolus injection or undiluted solution.
Danish: Caelyx må ikke administreres som bolusinjektion eller ufortyndet koncentrat.
English: Cytotoxic
Danish: Cytostatikum
English: One ml of Caelyx contains 2 mg of doxorubicin hydrochloride in a pegylated liposomal formulation.
Danish: En ml Caelyx indeholder 2 mg doxorubicinhydrochlorid i en pegyleret liposomal formulering.
English: The pharmacokinetics of Caelyx determined in 11 patients with ovarian carcinoma were similar to the pharmacokinetics determined in the larger population of 120 patients with various cancers.
Danish: Farmakokinetikken af Caelyx bestemt i 11 patienter med ovariecarcinom svarede til farmakokinetikken bestemt i en større population på 120 patienter med forskellige cancerformer.
English: Grade 2 1,000 - < 1,500 50,000 - < 75,000 Wait until ANC  1,500 and platelets
Danish: Grad 2 1.000 - < 1.500 50.000 - < 75.000 Vent til ANC  1.500 og blodplader  75.000; gendoser uden dosisreduktion.
English: Peripheral sensory neuropathy, neuralgia, headache
Danish: Perifer sanseneuropati, neuralgi, hovedpine
English: Please note that each vial of Caelyx contains sucrose and the dose is administered in 5% (50 mg/ml) glucose solution for infusion.
Danish: Bemærk, at hvert hætteglas Caelyx indeholder saccharose og dosis indgives i glucose 50 mg/ml (5 %) infusionsvæske, opløsning.
English: Pruritus, papular rash, allergic dermatitis, erythema, skin hyperpigmentation, petechiae, alopecia, medicine eruption
Danish: Pruritus, papuløst udslæt, allergisk dermatitis, erytem, hyperpigmentering af hud, petekkier, alopeci, udslæt pga. medicinsk behandling
English: CAELYX CARTON 50 mg/25 ml - 1 vial CAELYX CARTON 50 mg/25 ml - 10 vials
Danish: CAELYX KARTON 50 mg/25 ml - 1 hætteglas CAELYX KARTON 50 mg/25 ml - 10 hætteglas
English: One ml of Caelyx contains 2 mg pegylated liposomal doxorubicin hydrochloride.
Danish: En ml Caelyx indeholder 2 mg pegyleret liposomal doxorubicinhydrochlorid.
English: 73 l/h/m2).
Danish: (24 til 73 liter/time/m2).
English: - The other ingredients are -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)-methoxypoly(oxyethylen)-40 sodium salt (MPEG-DSPE), fully hydrogenated soy phosphatidylcholine (HSPC), cholesterol, ammonium sulphate, sucrose, histidine, water for injections, hydrochloric acid (for pH-adjustment) and sodium hydroxide (for pH-adjustment).
Danish: - Øvrige indholdsstoffer: -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl) - methoxypoly(oxyethylen)-40 natriumsalt (MPEG-DSPE), helhydrogeneret sojafosfatidylcholin (HSPC), kolesterol, ammoniumsulfat, saccharose, histidin, vand til injektion, saltsyre (til justering af pH) og natriumhydroxid (til justering af pH).
English: Gastrointestinal disorders very common nausea common diarrhoea, stomatitis, vomiting, mouth ulceration, abdominal pain, glossitis, constipation, nausea and vomiting
Danish: Mave-tarm-kanalen meget almindelig kvalme almindelig diarre, stomatitis, opkastning, mundsår, abdominalsmerter, glossitis, obstipation, kvalme og opkastning
English: CAELYX CARTON 20 mg/10 ml - 1 vial CAELYX CARTON 20 mg/10 ml - 10 vials
Danish: CAELYX KARTON 20 mg/10 ml - 1 hætteglas CAELYX KARTON 20 mg/10 ml - 10 hætteglas
English: Caelyx should not be used interchangeably with other formulations of doxorubicin hydrochloride.
Danish: Caelyx må ikke ombyttes med andre formuleringer af doxorubicinhydrochlorid.
English: Nausea, stomatitis, vomiting, abdominal pain, diarrhoea
Danish: Kvalme, stomatitis, opkastning, abdominalsmerte, diarre
English: Arthralgia, myalgia, muscle spasms, muscular weakness, musculoskeletal pain, musculoskeletal chest pain
Danish: Artralgi, myalgi, muskelkrampe, muskulær svaghed, smerte i bevægeapparatet, smerte i bevægeapparatet i brystregionen
English: The mean intrinsic clearance was 0.021 l/h/m2 (range 0.009-0.041 l/h/m2), the mean central volume of distribution was 1.95 l/m 2 (range 1.67-2.40 l/m 2).
Danish: Den gennemsnitlige intrinsic clearance var 0,021 liter/time/m2 (interval fra 0,009 - 0,041 liter/time/m2), det gennemsnitlige centrale fordelingsvolumen var 1,95 liter/m 2 (interval fra 1,67 - 2,40 liter/m 2).
English: See Table 6 for undesirable effects reported in Caelyx-treated patients.
Danish: Se tabel 6 for bivirkninger rapporteret hos patienter behandlet med Caelyx.
English: A phase III randomised, parallel-group, open-label, multicentre study comparing the safety and efficacy of Caelyx plus bortezomib combination therapy with bortezomib monotherapy in patients with multiple myeloma who have received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy, was conducted in 646 patients.
Danish: I en randomiseret fase III open-label multicenter-undersøgelse med parallelgruppe, der blev udført hos 646 patienter, blev sikkerhed og effekt af kombinationsbehandling med Caelyx og bortezomib sammenlignet med bortezomib monoterapi hos patienter med myelomatose.
English: Grade 3 500 - < 1,000 25,000 - < 50,000 Wait until ANC  1,500 and platelets
Danish: Grad 3 500 - < 1.000 25.000 - < 50.000 Vent til ANC  1.500 og blodplader  75.000; gendoser uden dosisreduktion.
English: Pharmacokinetic parameters in Caelyx-treated AIDS-KS patients Mean + standard error
Danish: Tabel 10. Farmakokinetiske parametre hos Caelyx-behandlede patienter med AIDSrelateret KS
English: If the patient experiences early symptoms or signs of infusion reaction (see sections 4.4 and 4.8), immediately discontinue the infusion, give appropriate premedications (antihistamine and/or short acting corticosteroid) and restart at a slower rate.
Danish: 4.4 og 4.8), seponer da øjeblikkeligt infusionen, giv hensigtsmæssig præmedicinering (antihistamin og/eller kortvirkende kortikosteroid) og start igen med en langsommere hastighed.
English: Intravenous use, following dilution in 5% (50 mg/ml) glucose solution for infusion.
Danish: Intravenøs anvendelse, efter fortynding med glucose 50 mg/ml (5 %) infusionsvæske, opløsning.
English: Asthenia, mucous membrane disorder
Danish: Asteni, lidelser i mukøse membraner
English: Very rare side effects (may affect up to 1 in 10,000 people) - serious skin reactions such as widespread peeling skin, blisters as well as mucous membrane erosion (Stevens-Johnson syndrome/toxic epidermal necrolysis); - oral cancer may occur when Caelyx is taken for a long time (more than one year).
Danish: Meget sjældne bivirkninger (kan berøre op til 1 ud af 10.000 personer) - alvorlige hudreaktioner såsom udbredt skallende hud, blærer samt slimhindeskader (Stevens
English: Abdominal pain, dyspepsia
Danish: Abdominal smerte, dyspepsi
English: Platelet count < 25,000/mm Haemoglobin < 8 g/dl ANC < 500/mm
Danish: På en hvilken som helst dag med indgivelse af medicin efter dag 1 for hver cyklus: Blodpladetal < 25.000/mm Hæmoglobin < 8 g/dl ANC < 500/mm
English: Prior to Caelyx administration, evaluate hepatic function using conventional clinical laboratory tests such as ALT/AST, alkaline phosphatase, and bilirubin.
Danish: Vurder leverfunktionen ved brug af konventionelle kliniske laboratorieundersøgelser såsom ALAT/ASAT, alkalisk fosfatase og bilirubin før indgift af Caelyx.
English: For doses < 90 mg: dilute Caelyx in 250 ml 5% (50 mg/ml) glucose solution for infusion.
Danish: For doser < 90 mg: fortynd Caelyx i 250 ml glucose 50 mg/ml (5 %) infusionsvæske, opløsning.
English: Pneumonia, nasopharyngitis, upper respiratory tract infection, oral candidiasis
Danish: Pneumoni, nasopharyngitis, infektion i øvre luftveje, svamp i munden
English: The appropriate dose of Caelyx must be diluted in 5% (50 mg/ml) glucose solution for infusion prior to administration.
Danish: Den opsugede dosis af Caelyx skal fortyndes i glucose 50 mg/ml (5 %) infusionsvæske, opløsning før indgivelse.
English: Bullous eruption, dermatitis, erythematous rash, nail disorder, scaly skin
Danish: Bulløs eruption, dermatitis, erytematøst udslæt, neglelidelse, skællende hud
English: For doses  90 mg: dilute Caelyx in 500 ml 5% (50 mg/ml) glucose solution for infusion.
Danish: For doser  90 mg: fortynd Caelyx i 500 ml glucose 50 mg/ml (5 %) infusionsvæske, opløsning.
English: Turnhoutseweg 30 B-2340 Beerse Belgium
Danish: B-2340 Beerse Belgien
English: Ovarian cancer program
Danish: Ovariecancer-program
English: Caelyx is administered at 30 mg/m² on day 4 of the bortezomib 3 week regimen as a 1 hour infusion administered immediately after the bortezomib infusion.
Danish: Caelyx blev givet i en dosis på 30 mg/m2 som intravenøs infusion over en time på 4. dagen efter indgivelsen af bortezomib.
English: What Caelyx is and what it is used for What you need to know before you use Caelyx How to use Caelyx
Danish: Det skal du vide, før du begynder at bruge Caelyx Sådan skal du bruge Caelyx Bivirkninger
English: * for more information on bortezomib dosing and dosage adjustment, see the SPC for bortezomib
Danish: * Der henvises til produktresumeet for bortezomib for mere information om bortezomibdosis og dosisjustering.
English: Lacrimation, blurred vision
Danish: Tåreflåd, sløret syn
English: - taking cool baths during hot weather; - avoiding vigorous exercise that might cause trauma to the feet (e.g., jogging); - avoiding exposure of skin to very hot water (e.g., jacuzzis, saunas); - avoiding tight fitting footwear or high-heeled shoes.
Danish: - undgå at udsætte huden for meget varmt vand (f.eks. i jacuzzi, sauna).
English: DO NOT USE INTERCHANGEABLY WITH OTHER FORMULATIONS OF DOXORUBICIN HYDROCHLORIDE.
Danish: MÅ IKKE OMBYTTES MED ANDRE FORMULERINGER AF DOXORUBICINHYDROCHLORID.
English: It must not be used interchangeably with other formulations of doxorubicin hydrochloride.
Danish: Det må ikke ombyttes med andre formuleringer af doxorubicinhydrochlorid.
English: 5% of the total dose should be infused slowly over the first 15 minutes.
Danish: Hos patienter, som oplever en infusionsreaktion, bør infusionsmetoden modificeres på følgende måde: 5 % af den totale dosis infunderes langsomt i løbet af de første 15 minutter.
English: CAELYX LABEL 20 mg/10 ml
Danish: CAELYX ETIKET 20 mg/10 ml
English: CAELYX LABEL 50 mg/25 ml
Danish: CAELYX ETIKET 50 mg/25 ml
English: The mean apparent half-life was 71.5 hours (range
Danish: Den gennemsnitlige tilsyneladende halveringstid var 75,0 timer (interval fra 36,1 - 125 timer).
English: Dehydration, cachexia
Danish: Dehydrering, kakeksi
English: For more detailed information on bortezomib dosing and dosage adjustments, see the SPC for bortezomib.
Danish: Der henvises til produktresumeet for bortezomib for mere detaljeret information om bortezomibdosis og dosisjustering.
English: Ovarian cancer patients
Danish: Ovariecancerpatienter
English: Abdominal pain, diarrhoea, nausea, stomatitis
Danish: Abdominalsmerte, diarre, kvalme, stomatitis
English: The mean intrinsic clearance of Caelyx was 0.030 l/h/m (range 0.008 to 0.152 l/h/m2) and the mean central volume of distribution was 1.93 l/m
Danish: Den gennemsnitlige intrinsic clearance af Caelyx var 0,030 liter/time/m2 (interval fra 0,008 til 0,152 liter/time/m2) og det gennemsnitlige centrale fordelingsvolumen var 1,93 liter/m2 (interval fra 0,96 - 3,85 liter/m2) nærmende sig plasmavolumen.
English: If you are being treated for multiple myeloma, and have already received at least 1 prior therapy, Caelyx will be administered at a dose of 30 mg per square metre of your body surface area (based on your height and weight) as a 1 hour intravenous infusion on day 4 of the bortezomib 3 week regimen immediately after the bortezomib infusion.
Danish: Hvis du behandles for myelomatose og allerede har modtaget mindst 1 tidligere behandling, vil Caelyx blive givet i en dosis på 30 mg per kvadratmeter af din legemsoverfladeareal (baseret på din højde og vægt).
English: AE by body system Breast cancer All severities n=254
Danish: Brystcancer Alle sværhedsgrader n=254
English: Manufacturer Janssen Pharmaceutica NV
Danish: Janssen Pharmaceutica NV Turnhoutseweg 30
English: Mouth ulceration, esophagitis, nausea and vomiting, gastritis, dysphagia, dry mouth, flatulence, gingivitis, taste perversion
Danish: Mundsår, øsofagitis, kvalme og opkastning, gastritis, dysfagi, mundtørhed, flatulens, tandkødsbetændelse, smagsforandring
English: GRADE
Danish: Vægttab
English: Anaemia, neutropaenia, thrombocytopaenia
Danish: Anæmi, neutropeni, trombocytopeni
English: Leukopaenia, anaemia, neutropaenia, thrombocytopaenia
Danish: Leukopeni, anæmi, neutropeni, trombocytopeni
English: Vesiculobullous rash, pruritus, exfoliative dermatitis, skin disorder, maculopapular rash, sweating, acne, skin ulcer
Danish: Bulløst udslæt med småblærer, pruritus, eksfoliativ dermatitis, hudlidelser, makulopapuløst udslæt, svedtendens, acne, sår på huden
English: Constipation, abdominal pain, dyspepsia
Danish: Obstipation, abdominalsmerter, dyspepsi
English: P-2740-262 Porto Salvo Tel: +351 214 368 600
Danish: P-2740-262 Porto Salvo
English: Peripheral oedema, chills, influenza-like illness, malaise, hyperthermia
Danish: Asteni, træthed Perifert ødem, kulderystelser, influenzalignende sygdom, utilpashed, hypertermi
English: Vasodilatation
Danish: Vasodilation
English: PLATELETS
Danish: BLODPLADER
English: reading, or listening to the radio); - keeping hands and feet uncovered (no gloves, socks, etc.); - staying in cool places;
Danish: - hold hænder og fødder frie (ingen handsker, strømper o.s.v.).
English: Anaemia, leukopaenia Febrile neutropaenia, lymphopaenia
Danish: Febril neutropeni, lymfopeni
English: Upper abdominal pain, mouth ulceration, dry mouth, dysphagia, aphthous stomatitis
Danish: Øvre abdominal smerte, mundsår, mundtørhed, dysfagi, stomatitis med blegner
English: Anaphylactoid response
Danish: Anafylaktoid reaktion
English: Weakness, fever, pain Asthenia, mucositis NOS
Danish: Svaghed, feber, smerte Asteni, ikke specifik mucositis
English: Nausea, stomatitis, vomiting
Danish: Kvalme, stomatitis, opkastning
English: Leukopaenia, anaemia, thrombocytopaenia
Danish: Leukopeni, anæmi, trombocytopeni
English: Cardiovascular disorder
Danish: Kardiovaskulære sygdomme
English: Abdominal pain, constipation, diarrhoea, dyspepsia, mouth ulceration
Danish: Abdominalsmerte, forstoppelse, diarre, dyspepsi, mundsår
English: Asthenia, mucous membrane disorder, pain
Danish: Asteni, lidelser i mucøse membraner, smerte
English: The doctor may wish to delay the start and/or reduce the dose of the next treatment (see Strategies to prevent and treat hand-foot syndrome, below); - pain or sores in mouth or throat, nausea, vomiting, diarrhoea, constipation, loss of appetite, weight loss; - decrease in the number of white blood cells, which can increase the chances of infections.
Danish: Lægen kan ønske at forsinke begyndelsen og/eller reducere dosis af den næste behandling (se Strategier for at modvirke og behandle hånd-fod syndrom, nedenunder).
English: You should tell your doctor about any of the following: - if you are receiving any treatment for heart disease or liver disease; - if you are diabetic, because Caelyx contains sugar which may require an adjustment to the treatment of your diabetes; - if you have Kaposi's sarcoma and have had your spleen removed; - if you notice sores, discolouration or any discomfort in your mouth.
Danish: Fortæl det til lægen eller apotekspersonalet, hvis noget af følgende passer på dig: - hvis du er i nogen form for behandling af hjerte- eller leversygdom.
English: How to store Caelyx
Danish: Sådan vil du få Caelyx
English: If you use more Caelyx than you should
Danish: Hvis du har fået for meget Caelyx
English: Nausea, diarrhoea, vomiting, stomatitis
Danish: Kvalme, diarre, opkastning, stomatitis
English: Lethargy, hypoaesthesia, syncope, dysaesthesia
Danish: Sløvhed, hypæstesi, synkope, dysæstesi
English: Of 646 patients with multiple myeloma who have received at least 1 prior therapy, 318 patients were treated with combination therapy of Caelyx 30 mg/m2 as a one hour intravenous infusion administered on day 4 following bortezomib which is administered at 1.3 mg/m² on days 1, 4, 8, and 11, every three weeks or with bortezomib monotherapy in a phase III clinical trial.
Danish: Bortezomib indgives i en dosis på 1,3 mg/m2 på dag 1, 4, 8 og 11 hver tredje uge eller som bortezomib monoterapi i en fase III klinisk undersøgelse.
English: Back pain, myalgia
Danish: Rygsmerter, myalgi
English: Paresthesia
Danish: Parestesi
English: 45.2-98.5 hours).
Danish: Gennemsnitlig tilsyneladende halveringstid var 71,5 timer (interval fra 45,2 - 98,5 timer).
English: Grade 1 1,500 - 1,900
Danish:  1/10.000 til < 1/1.000
English: Constipation, diarrhoea, nausea, stomatitis, vomiting
Danish: Forstoppelse, diarre, kvalme, stomatitis, opkastning
English: Nausea, diarrhoea, vomiting, constipation, stomatitis
Danish: Kvalme, diarre, opkastning, forstoppelse, stomatitis
English: Treatment related undesirable effects reported in breast cancer clinical trials (50 mg/m2 every 4 weeks) (Caelyx-treated patients) by severity, MedDRA system organ class and preferred term
Danish: Behandlingsrelaterede bivirkninger rapporteret i brystcancer kliniske undersøgelser (50 mg/m2 hver 4. uge) (Caelyx-behandlede patienter) efter sværhedsgrad, systemorganklasser i henhold til MedDRA-databasen og standardterminologi Meget almindelig (≥ 1/10); Almindelig (≥ 1/100 til < 1/10); Ikke almindelig (≥ 1/1.000 til < 1/100)
English: Treatment related undesirable effects reported in ovarian cancer clinical trials (50 mg/m2 every 4 weeks) (Caelyx-treated patients) by severity, MedDRA system organ class and preferred term
Danish: Behandlingsrelaterede bivirkninger rapporteret i ovariecancer kliniske undersøgelser (50 mg/m2 hver 4. uge) (Caelyx-behandlede patienter) efter sværhedsgrad, systemorganklasser i henhold til MedDRA-databasen og standardterminologi Meget almindelig (≥ 1/10); Almindelig (≥ 1/100 til < 1/10); Ikke almindelig (≥ 1/1.000 til
English: Caelyx is an antitumour agent.
Danish: Caelyx er et lægemiddel mod tumorer/svulster.
English: Contact your doctor immediately if: - you get reddening painful skin on your hands and feet; - you get painful reddening of the skin and/or blisters on the body or in the mouth; - you get heart problems; - you get mouth sores; - you develop a fever or any other sign of an infection; - you get sudden shortness of breath or sharp chest pain that may worsen with deep breathing or coughing; - you get swelling, warmth, or tenderness in the soft tissues of your leg, sometimes with pain which gets worse when you stand or walk.
Danish: - du får hævelse, varme eller ømhed i det bløde væv på dine ben, nogle gange med smerter, der bliver værre, når du står eller går.
English: Constipation, dyspepsia, mouth ulceration
Danish: Forstoppelse, dyspepsi, mundsår
English: Abdominal pain, dyspepsia, mouth ulceration
Danish: Abdominalsmerte, dyspepsi, mundsår
English: CIOMS III AE by body system Ovarian cancer All severities n=512
Danish: Ovariecancer Alle sværhedsgrader/ n=512
English: Women of child-bearing potential
Danish: Fertile kvinder
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine Sandoz on 11 December 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rivastigmine Sandoz den 11. december 2009.
English: The full EPAR for Rivastigmine Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Rivastigmine Sandoz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Rivastigmine Sandoz should be given twice a day, with morning and evening meals.
Danish: Rivastigmine Sandoz skal gives to gange dagligt, sammen med morgen- og aftensmåltidet.
English: This is a summary of the European public assessment report (EPAR) for Rivastigmine Sandoz.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rivastigmine Sandoz.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rivastigmine Sandoz.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Rivastigmine Sandoz.