FrancophonIA/ELRC3.0 huggingface dataset:
English: Common Common Common Uncommon Uncommon Very rare Not known
Danish: Almindelig Almindelig Almindelig Almindelig Ikke almindelig Ikke almindelig Meget sjælden Ikke kendt
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelig (kan ramme op til 1 patient ud af 100)
English: Each Rivastigmine Sandoz 4.5 mg capsule contains 4.5 mg of rivastigmine.
Danish: Hver Rivastigmine Sandoz 4,5 mg kapsel indeholder 4,5 mg rivastigmin.
English: Only for carton box: Rivastigmine Sandoz 2 mg/ml
Danish: Kun for kartonæske: Rivastigmine Sandoz 2 mg/ml
English: Common (may affect up to 1 in 10 people)
Danish: Almindelig (kan ramme op til 1 patient ud af 10)
English: Rivastigmine Sandoz 4.5 mg hard capsules:
Danish: Rivastigmine Sandoz 4,5 mg hårde kapsler:
English: Only for carton box: Rivastigmine Sandoz 1.5 mg
Danish: Kun for kartonæske: Rivastigmine Sandoz 1,5 mg
English: How to take Rivastigmine Sandoz
Danish: Sådan skal du tage Rivastigmine Sandoz
English: Each ml contains rivastigmine hydrogen tartrate corresponding to 2 mg rivastigmine.
Danish: Hver ml indeholder rivastigmin-hydrogentartrat svarende til 2 mg rivastigmin.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 6mg rivastigmine.
Danish: Hver kapsel indeholder rivastigminhydrogentartrat svarende til 6 mg rivastigmin.
English: - Magnesium stearate - Hypromellose - Silica, colloidal anhydrous
Danish: Kapselindhold: - Mikrokrystallinsk cellulose - Magnesiumstearat - Hypromellose - Silica, colloid vandfri
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 4,5mg rivastigmine.
Danish: Hver kapsel indeholder rivastigminhydrogentartrat svarende til 4,5 mg rivastigmin.
English: Only for carton box: Rivastigmine Sandoz 4.5 mg
Danish: Kun for kartonæske: Rivastigmine Sandoz 4,5 mg
English: - Rivastigmine Sandoz 3 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “RIV 3 mg” on the body.
Danish: - Rivastigmine Sandoz 3 mg hårde kapsler, som indeholder et råhvidt til svagt gulligt pulver, har en orange hætte og en orange skal med "RIV 3 mg" præget med rødt på kapselskallen.
English: Only for carton box: Rivastigmine Sandoz 6 mg
Danish: Kun for kartonæske: Rivastigmine Sandoz 6 mg
English: - Rivastigmine Sandoz 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with a red imprint “RIV 1.5 mg” on the body.
Danish: - Rivastigmine Sandoz 1,5 mg hårde kapsler, som indeholder et råhvidt til svagt gulligt pulver, har en gul hætte og en gul skal med "RIV 1,5 mg" præget med rødt på kapselskallen.
English: Only for carton box: Rivastigmine Sandoz 3 mg
Danish: Kun for kartonæske: Rivastigmine Sandoz 3 mg
English: - Rivastigmine Sandoz 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint “RIV 4.5 mg” on the body.
Danish: - Rivastigmine Sandoz 4,5 mg hårde kapsler, som indeholder et råhvidt til svagt gulligt pulver, har en rød hætte og en rød skal med "RIV 4,5 mg" præget med hvidt på kapselskallen.
English: - if you have, or have ever had an active stomach ulcer.
Danish: - hvis du har eller har haft mavesår.
English: Rivastigmine Sandoz 6 mg hard capsules rivastigmine (as hydrogen tartrate)
Danish: Rivastigmine Sandoz 6 mg hårde kapsler rivastigmin (som hydrogentartrat)
English: Rivastigmine Sandoz 1.5 mg hard capsules rivastigmine (as hydrogen tartrate)
Danish: Rivastigmine Sandoz 1,5 mg hårde kapsler rivastigmin (som hydrogentartrat)
English: What Rivastigmine Sandoz looks like and contents of the pack
Danish: Rivastigmine Sandoz' udseende og pakningstørrelse
English: Agitation Confusion Anxiety Nightmares Insomnia Depression Hallucinations
Danish: Træthed- eller svaghedsfornemmelse Generel utilpashed Rysten eller følelse af forvirring Nedsat appetit
English: Rivastigmine Sandoz 3 mg hard capsules rivastigmine (as hydrogen tartrate)
Danish: Rivastigmine Sandoz 3 mg hårde kapsler rivastigmin (som hydrogentartrat)
English: Rivastigmine Sandoz 4.5 mg hard capsules rivastigmine (as hydrogen tartrate)
Danish: Rivastigmine Sandoz 4,5 mg hårde kapsler rivastigmin (som hydrogentartrat)
English: - Rivastigmine Sandoz 6 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “RIV 6 mg” on the body.
Danish: - Rivastigmine Sandoz 6 mg hårde kapsler, som indeholder et råhvidt til svagt gulligt pulver, har en rød hætte og en orange skal med "RIV 6 mg" præget med rødt på kapselskallen.
English: Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “RIV 4.5 mg” on the body.
Danish: Råhvidt til svagt gulligt pulver i en kapsel med rød hætte og rød skal, med ”RIV 4,5 mg” præget med hvidtt på kapselskallen.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 3mg rivastigmine.
Danish: Hver kapsel indeholder rivastigminhydrogentartrat svarende til 3 mg rivastigmin.
English: Sandoz Pharmaceuticals GmbH
Danish: Sandoz Pharmaceuticals DD
English: How to store Rivastigmine Sandoz
Danish: opbevaring af Rivastigmine Sandoz
English: If you take more Rivastigmine Sandoz than you should
Danish: Hvis du har taget for meget Rivastigmine Sandoz
English: A.
Danish: S.A.
English: • Nightmares
Danish: • Svedtendens
English: If you accidentally take more Rivastigmine Sandoz than you should, inform your doctor.
Danish: Hvis du vil have yderligere oplysninger om Rivastigmine Sandoz, skal du henvende dig til den lokale repræsentant:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Inlyta on 3 September 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Inlyta den 3. september 2012.
English: It is available as tablets (1, 3, 5 and 7 mg).
Danish: Det leveres som tabletter (1, 3, 5 og 7 mg).
English: This is a summary of the European public assessment report (EPAR) for Inlyta.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Inlyta.
English: The full EPAR for Inlyta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Inlyta findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In patients taking certain other medicines, the doctor may need to adjust the dose of Inlyta.
Danish: Hos patienter, der tager visse andre lægemidler, kan lægen være nødt til at justere dosis af Inlyta.
English: A risk management plan has been developed to ensure that Inlyta is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Inlyta anvendes så sikkert som muligt.
English: Regarding its safety, the side effects of the medicine are similar to other medicines in the same class and are considered to be acceptable and manageable.
Danish: Hvad sikkerheden angår, svarer lægemidlets bivirkninger til bivirkningerne af andre lægemidler i samme klasse og anses for at være acceptable og behandlelige.
English: The most common side effects with Inlyta (seen in more than 20% of patients) are diarrhoea, hypertension (high blood pressure), fatigue (tiredness), dysphonia (speech disturbance), nausea (feeling sick), vomiting, decreased appetite, weight loss, palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms of the hands and soles of the feet), haemorrhage (bleeding), hypothyroidism (an underactive thyroid gland), protein in urine, cough and constipation.
Danish: De mest almindelige bivirkninger med Inlyta (som forekommer hos mere end 20 % af patienterne) er diarré, hypertension (forhøjet blodtryk), træthed, dysfoni (taleforstyrrelser), kvalme, opkastninger, nedsat appetit, vægttab, palmar-plantar erytrodysæstesi (udslæt og følelsesløshed af håndflader og fodsåler), hæmoragi (blødning), hypothyreose (lavt stofskifte ), protein i urinen, hoste og forstoppelse.
English: ‘Advanced' means that the cancer has started to spread.
Danish: Fremskreden betyder, at kræften er begyndt at brede sig.
English: Other information about Inlyta
Danish: Andre oplysninger om Inlyta
English: Patients taking Inlyta lived for an average of 6.7 months without the disease getting worse, compared with 4.7 months in the patients taking sorafenib.
Danish: De patienter, der fik Inlyta, levede i gennemsnit 6,7 måneder, uden at sygdommen blev værre, sammenholdt med 4,7 måneder for dem, der fik sorafenib.
English: For more information about treatment with Inlyta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Inlyta, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The recommended starting dose is 5 mg twice a day, taken approximately 12 hours apart.
Danish: Den anbefalede startdosis er 5 mg to gange dagligt, der skal tages med cirka 12 timers mellemrum.
English: In patients who tolerate the 5 mg dose well, who do not have high blood pressure and are not taking blood pressure medicines, the dose may be increased first to 7 mg then to a maximum of 10 mg twice a day.
Danish: Hos patienter, der tåler en dosis på 5 mg uden problemer, og som ikke har højt blodtryk og ikke får blodtrykssænkende lægemidler, kan dosis øges, først til 7 mg og derefter til højst 10 mg to gange dagligt.
English: What measures are being taken to ensure the safe and effective use of Inlyta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Inlyta?
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 Inlyta.
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, hvordan Inlyta skal anvendes.
English: Treatment with Inlyta should be started by doctors who have experience in using cancer medicines.
Danish: Behandling med Inlyta bør indledes af en læge med erfaring i brug af lægemidler mod kræft.
English: Inlyta is a medicine that contains the active substance axitinib.
Danish: Inlyta er et lægemiddel, der indeholder det aktive stof axitinib.
English: Patients with moderately reduced liver function should receive a starting dose of 2 mg twice a day.
Danish: Hos patienter med moderat nedsat leverfunktion bør startdosis være 2 mg to gange dagligt.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Inlyta, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Inlyta, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The CHMP therefore decided that Inlyta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede derfor, at fordelene ved Inlyta opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Inlyta.
English: Inlyta should not be used in patients with severely reduced liver function.
Danish: Inlyta bør ikke anvendes ved svært nedsat leverfunktion.
English: The active substance in Inlyta, axitinib, works by blocking some enzymes known as tyrosine kinases that are found in ‘vascular endothelial growth factor' (VEGF) receptors on the surface of cancer cells.
Danish: Det aktive stof i Inlyta, axitinib, virker ved at blokere tyrosinkinaser, der er enzymer i receptorerne for "vaskulær endotelial vækstfaktor" (VEGF) på kræftcellernes overflade.
English: Why has Inlyta been approved?
Danish: Hvorfor blev Inlyta godkendt?
English: The main measure of effectiveness was how long the patients lived without their tumour getting worse.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor længe patienterne overlevede, uden at kræftsygdommen forværredes.
English: Inlyta is used when treatment with Sutent (sunitinib) or ‘cytokines' (other cancer medicines) has failed.
Danish: Inlyta anvendes, når behandlingen med Sutent (sunitinib) eller "cytokiner" (andre lægemidler mod kræft) har slået fejl.
English: What is the risk associated with Inlyta?
Danish: Hvilken risiko er der forbundet med Inlyta?
English: It may be necessary to reduce the dose or interrupt treatment to manage certain side effects.
Danish: Visse bivirkninger kan gøre det nødvendigt at sætte dosis ned eller afbryde behandlingen.
English: For the full list of all side effects and restrictions with Inlyta, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger og begrænsninger ved Inlyta fremgår af indlægssedlen.
English: VEGF receptors are involved in the growth and spread of cancer cells and in the development of blood vessels that supply the tumours.
Danish: VEGF-receptorerne medvirker til kræftcellers vækst og spredning og til udvikling af de blodkar, der forsyner svulsterne.
English: Effects were better for those patients who were previously treated with cytokines rather than sunitinib.
Danish: Virkningen var bedre hos dem, der i forvejen var blevet behandlet med cytokiner, end hos dem, der var blevet behandlet med sunitinib.
English: By blocking these receptors, Inlyta helps to reduce the growth and spread of the cancer and cut off the blood supply that keeps the cancer cells growing.
Danish: Ved at blokere disse receptorer bremser Inlyta kræftens vækst og spredning og afskærer den blodforsyning, som sætter kræftcellerne i stand til at vokse.
English: Inlyta was more effective than sorafenib in treating advanced renal cell carcinoma.
Danish: Inlyta var mere effektivt end sorafenib til behandling af fremskredent renalcellecarcinom.
English: What is Inlyta?
Danish: Hvad er Inlyta?
English: The dose can be adjusted according to the patient's response.
Danish: Dosis kan tilpasses efter behandlingens virkning.
English: The CHMP concluded that the effectiveness of Inlyta in treating patients with advanced renal cell carcinoma for whom treatment with Sutent or a cytokine failed has been demonstrated.
Danish: CHMP konkluderede, at Inlytas virkning er bevist til behandling af fremskredent renalcellecarcinom, hvor behandling med Sutent eller et cytokin er slået fejl.
English: What is Inlyta used for?
Danish: Hvad anvendes Inlyta til?
English: Inlyta is used to treat adults with advanced renal cell carcinoma, a type of kidney cancer.
Danish: Inlyta anvendes til behandling af voksne patienter med fremskredent renalcellecarcinom, der er en form for nyrekræft.
English: Inlyta has been compared with sorafenib (another cancer medicine) in one main study involving 723 patients with advanced renal cell carcinoma whose previous treatment with other cancer medicines such as sunitinib or cytokines had failed.
Danish: Inlyta er blevet sammenlignet med sorafenib (et andet lægemiddel mod kræft) i én hovedundersøgelse, der omfattede 723 patienter med fremskredent renalcellecarcinom.
English: How is Inlyta used?
Danish: Hvordan anvendes Inlyta?
English: What benefit has Inlyta shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Inlyta?
English: How has Inlyta been studied?
Danish: Hvordan blev Inlyta undersøgt?
English: It involved 366 adults and children 2 years of age and over.
Danish: Den omfattede 366 voksne og børn på 2 år og derover.
English: This was switched to a full marketing authorisation on 16 November 2015.
Danish: Den blev ændret til en fuldgyldig markedsføringstilladelse den 16. november 2015.
English: Partial onset seizures
Danish: Partielle anfald
English: Other information about Votubia
Danish: Andre oplysninger om Votubia
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full authorisation.
Danish: Da virksomheden har indsendt de fornødne supplerende oplysninger, er godkendelsen ændret fra en betinget godkendelse til en fuldgyldig godkendelse.
English: Votubia received a conditional marketing authorisation valid throughout the EU on 2 September 2011.
Danish: Votubia fik markedsføringstilladelse med gyldighed i hele EU den 2. september 2011.
English: The side effects of the medicine were considered to be manageable and were generally mild or moderate.
Danish: Bivirkningerne ved lægemidlet blev anset for at være håndterbare og var generelt milde eller moderate.
English: As for all medicines, data on the use of Votubia are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Votubia løbende overvåget.
English: If patients experience severe side effects the doctor may need to reduce the dose or interrupt treatment temporarily.
Danish: Hvis patienten oplever svære bivirkninger, kan det være nødvendigt, at lægen nedsætter dosis eller afbryder behandlingen midlertidigt.
English: An overview of Votubia and why it is authorised in the EU
Danish: En oversigt over Votubia, og hvorfor det er godkendt i EU
English: Tuberous sclerosis is rare, and Votubia was designated an ‘orphan medicine' (a medicine used in rare diseases) on 4 August 2010.
Danish: Tuberøs sklerose er sjælden, og Votubia blev udpeget som "lægemiddel til sjældne sygdomme" den 4. august 2010.
English: Votubia contains the active substance everolimus.
Danish: Votubia indeholder det aktive stof everolimus.
English: What measures are being taken to ensure the safe and effective use of Votubia?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Votubia?
English: The Agency therefore concluded that the benefits of Votubia outweigh its risks and recommended that it be given marketing authorisation.
Danish: Agenturet konkluderede derfor, at fordelene opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Votubia.
English: It is available as tablets (2.5, 5 and 10 mg) and as dispersible tablets (1, 2, 3 and 5 mg) and is taken by mouth once a day at the same time every day, consistently either with or without food.
Danish: Det fås som tabletter (2,5 mg, 5 mg og 10 mg) og som dispergible tabletter (2 mg, 3 mg og 5 mg) og indtages gennem munden én gang om dagen på samme tid hver dag, konsekvent enten sammen med eller uden mad.
English: Votubia was originally given ‘conditional authorisation' because there was more evidence to come about the medicine, in particular its long-term effects.
Danish: Votubia blev oprindeligt godkendt under "særlige omstændigheder", da der afventedes yderligere dokumentation om lægemidlet, navnlig vedrørende dets langsigtede virkninger.
English: Side effects reported with Votubia are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Votubia vurderes omhyggeligt, og der tages de nødvendig forholdsregler for at beskytte patienterne.
English: When used together with other medicines, e.g. as an add-on treatment for seizures, the dosage may also be affected by the other medicines being taken.
Danish: Ved brug sammen med andre lægemidler, f.eks. som tillægsbehandling for anfald, kan doseringen også blive påvirket af de andre lægemidler, der tages.
English: In patients with renal angiomyolipoma, the recommended dose is 10 mg once a day.
Danish: Hos patienter med renal angiomyolipoma er den anbefalede dosis 10 mg én gang dagligt.
English: It has also shown to be effective at reducing partial-onset seizures associated with tuberous sclerosis.
Danish: Det har også vist sig effektivt til at mindske partielle anfald forbundet med tuberøs sklerose.
English: What is Votubia and what is it used for?
Danish: Hvad er Votubia, og hvad anvendes det til?
English: Further information on Votubia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere information om Votubia findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: In the body, everolimus first attaches to a protein called FKBP-12 that is found inside cells to make a ‘complex'.
Danish: Everolimus binder sig i kroppen først til et protein kaldet FKBP-12, der findes i cellerne, hvorved det danner et "kompleks".
English: Votubia is a medicine used to treat the following benign (non-cancerous) tumours caused by the genetic disease tuberous sclerosis:
Danish: Votubia er et lægemiddel til behandling af følgende godartede (ikkekankrøse) tumorer forårsaget af den genetiske sygdom tuberøs sklerose:
English: Two different dosage regimens of add-on treatment with Votubia (tailored to give lower or higher levels in the blood) were compared with placebo.
Danish: To forskellige doseringer som led i tillægsbehandling med Votubia (tilrettelagt med henblik på højere eller lavere indhold i blodet) blev sammenlignet med placebo.
English: Votubia treatment should be started by a doctor experienced in treating tuberous sclerosis and in monitoring levels of medicine in the blood.
Danish: Behandlingen med Votubia skal indledes af en læge med erfaring i behandling af tuberøs sklerose og overvågning af lægemiddelindholdet i blodet.
English: The most common side effects with Votubia (seen in more than 1 in 10 patients) are acne, stomatitis (inflammation of the lining of the mouth), upper respiratory tract infections (colds), nasopharyngitis (inflammation of the nose and throat), sinusitis (inflammation of the sinuses), cough, pneumonia (infection of the lung), urinary tract infection, increased blood levels of cholesterol, irregular menstruation (periods), amenorrhoea (absence of periods), headache, diarrhoea, vomiting, rash, tiredness, fever and decreased appetite.
Danish: De hyppigste bivirkninger ved Votubia (som optræder hos flere end 1 ud af 10 patienter) er akne, inflammation af mundslimhinden (stomatitis), infektioner i de øvre luftveje (forkølelser), betændelse i næse og hals (nasopharyngitis), bihulebetændelse (sinusitis), forkølelse, lungebetændelse (pneumoni), urinvejsinfektion, øgede mængder kolesterol i blodet, uregelmæssig menstruation, udeblivende menstruation (amenoré), hovedpine, diarré, opkastning, udslæt, træthed, feber og nedsat appetit.
English: For SEGA, and for use as add-on treatment of seizures, the starting dose depends on the body surface area (calculated using the patient's height and weight) and the patient's age, but the doctor will adjust the dose based on the patient's blood levels of the medicine and how well the patient tolerates the medicine.
Danish: I forbindelse med SEGA og brug som tillægsbehandling for anfald afhænger startdosen af legemsoverfladen (beregnet ud fra patientens højde og vægt) og patientens alder, men lægen vil tilpasse dosen på grundlag af indholdet af lægemidlet i patientens blod, og alt efter hvor godt patienten tolererer lægemidlet.
English: In renal angiomyolipoma caused by tuberous sclerosis, Votubia has been compared with placebo in one study involving 118 adults.
Danish: Til behandling af renal angiomyolipoma forårsaget af tuberøs sklerose er Votubia blevet sammenlignet med placebo i et studie, der omfattede 118 voksne.
English: Why is Votubia authorised in the EU?
Danish: Hvorfor blev Votubia godkendt i EU?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Votubia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Votubia findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.