FrancophonIA/ELRC3.0 huggingface dataset:
English: a The starting dose is the dose at which treatment should be initiated b Higher vandetanib doses than 150 mg/m2 have not been used in clinical studies in paediatric patients c Patients with an adverse reaction requiring a dose reduction should stop taking vandetanib for at least a week.
Danish: a Startdosis er den dosis, som behandlingen bør indledes med. b I kliniske studier med pædiatriske patienter er der ikke anvendt vandetanib-doser over 150 mg/m2.
English: • methadone (used to treat addiction), haloperidol, chlorpromazine, sulpiride, amisulpride, and zuclopenthixol, (used to treat mental illness)
Danish: • metadon (mod stofmisbrug), haloperidol, chlorpromazin, sulpirid, amisulprid og zuclopenthixol
English: • vitamin K antagonists and dabigatran often referred to as ‘blood thinners'
Danish: • såkaldte 'blodfortyndende midler' såsom vitamin K-antagonister og dabigatran
English: The concomitant use of vandetanib with ondansetron is not recommended (see section 4.5)
Danish: Vandetanib bør ikke anvendes samtidig med ondansetron (se pkt.
English: Therefore, no change in dose of vandetanib is required when vandetanib is given with either omeprazole or ranitidine.
Danish: Justering af vandetanibdosis er ikke nødvendig ved samtidig administration af hverken omeprazol eller ranitidin.
English: • Before starting Caprelsa
Danish: • Før du begynder at tage Caprelsa
English: Only one supply per prescription is allowed.
Danish: Lægemidlet må kun udleveres én gang efter samme recept.
English: The median PFS for patients randomised to vandetanib has not been reached; however, based on statistical modelling of data observed up to the 43rd percentile, the median PFS is predicted to be
Danish: Den mediane PFS for patienter randomiseret til vandetanib er ikke blevet nået; den mediane PFS prædikteres på basis af statistisk modellering af data observeret op til den 43 percentil at være 30,5 måneder med et 95 % konfidens-interval på 25,5 til 36,5 måneder.
English: Each tablet contains 100 or 300 mg of vandetanib.
Danish: Hver tablet indeholder 100 mg eller 300 mg vandetanib.
English: België/Belgique/Belgien/ Luxembourg/Luxemburg Sanofi Belgium Tél/Tel: + 32 (0)2 710 54 00
Danish: Sanofi Belgium Tél/Tel: + 32 (0)-2 710 54 00
English: A value > 1 favors vandetanib.
Danish: En værdi <1 i vandetanibs favør.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines that you buy without a prescription and herbal medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: • Swelling of the brain.
Danish: • Hævelser i hjernen.
English: Asthenia, fatigue, pain, oedema
Danish: Asteni, træthed, smerter, ødem
English: Due to the 19-day half-life, adverse reactions including a prolonged QTc interval may not resolve quickly (see section 4.4).
Danish: Patienten skal overvåges på passende vis. Som følge af den 19 dages halveringstid vil bivirkninger, herunder et forlænget QTc-interval, muligvis ikke forsvinde hurtigt (se pkt.
English: Vandetanib is not recommended for use in adult and paediatric patients with moderate or severe renal impairment since there is limited data, and safety and efficacy have not been established (see sections 4.2, 5.1, and 5.2).
Danish: Vandetanib anbefales ikke til voksne og pædiatriske patienter med moderat eller svært nedsat nyrefunktion, da der er begrænsede data, og sikkerhed og virkning ikke er klarlagt (se pkt.
English: Caprelsa 300 mg tablets
Danish: Caprelsa 300 mg tabletter
English: Teeth and bone development abnormalities in pediatric patients
Danish: Abnormiteter i udviklingen af tænder og knogler hos den pædiatriske population
English: Caprelsa 100 mg tablets
Danish: Caprelsa 100 mg tabletter
English: Respiratory failure, pneumonia aspiration
Danish: Respirationssvigt, bronkopneumoni
English: • In the event of CTCAE grade 3 or higher toxicity or prolongation of the ECG QTc interval, dosing with vandetanib should be at least temporarily stopped and resumed at a reduced dose when toxicity has resolved or improved to CTCAE grade 1.
Danish: • I tilfælde af CTCAE-grad 3 eller højere toksicitet eller forlænget QTc-interval i EKG skal indgift af vandetanib som minimum afbrydes midlertidigt og genoptages med en reduceret dosis, når toksiciteten er forsvundet eller bedret til CTCAE-grad 1.
English: 100 daily
Danish: 100 dagligt
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 February 2012
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Visual impairment, halo vision, photopsia, glaucoma, conjunctivitis, dry eye, keratopathy
Danish: Nedsat syn, aura, fotopsi, glaukom, conjunctivitis, tørre øjne, keratopati
English: Tlf: +45 45 16 70 00
Danish: Sanofi A/S Tlf: +45 45 16 70 00
English: • Feeling sick (nausea).
Danish: • Sygdomsfornemmelse (kvalme).
English: There is limited data with 300 mg in patients with moderate renal impairment: the dose needed to be lowered to 200 mg in 5 out of 6 patients.
Danish: Dosis skulle reduceres til 200 mg hos 5 ud af 6 patienter.
English: • If QTc increases markedly but stays below 500 msec, the advice of a cardiologist should be sought;
Danish: • En kardiolog bør konsulteres, hvis QTc forlænges markant, men holder sig under 500 ms;
English: • Pneumonia that happens when you breathe in foreign matter into your lungs.
Danish: • Lungebetændelse grundet indånding af fremmedlegemer.
English: • Feeling unsteady.
Danish: • Usikker fornemmelse.
English: • cyclosporine and tacrolimus (used to treat transplant rejection), digoxin (used to treat irregular heart rate), and metformin (used to control your blood sugar)
Danish: • ciclosporin og tacrolimus (til at forhindre afstødning af et organ efter transplantation), digoxin
English: Vandetanib doses higher than 150 mg/m2 have not been used in clinical studies in paediatric patients.
Danish: I kliniske studier med pædiatriske patienter er der ikke anvendt vandetanib-doser over 150 mg/m2.
English: Common (affects less than 1 in 10 people)
Danish: Almindelig (ses hos mindre end 1 ud af 10 personer):
English: • Decreased levels of calcium in your blood.
Danish: • Nedsat niveau af calcium i blodet.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/749/002
Danish: EU/1/11/749/001 EU/1/11/749/002
English: • Inability to control your bowel movements.
Danish: • Manglende evne til at styre tarmfunktionen.
English: • Urinary tract infections.
Danish: • Urinvejsinfektioner.
English: • Coughing up of blood.
Danish: • Hoste med blodigt opspyt.
English: Posology for MTC in adult patients
Danish: Dosering ved MTC hos voksne patienter
English: In the event of common terminology criteria for adverse events (CTCAE) grade 3 or higher toxicity or prolongation of the ECG QTc interval, dosing with vandetanib should be at least temporarily stopped and resumed at a reduced dose when toxicity has resolved or improved to CTCAE grade 1 (see section 4.4).
Danish: I tilfælde af grad 3 bivirkning, vurderet ud fra common terminology criteria for adverse events (CTCAE) eller højere toksicitet eller forlænget QTc-interval i EKG skal indgift af vandetanib som minimum afbrydes midlertidigt og genoptages med en reduceret dosis, når toksiciteten er forsvundet eller bedret til CTCAE-grad 1 (se pkt.
English: • Disorder of the cornea of the eye (keratopathy).
Danish: • Forandring af øjets hornhinde (keratopati).
English: If QTc increases markedly but stays below 500 msec, cardiologist advice should be sought.
Danish: En kardiolog bør konsulteres, hvis QTc stiger markant, men holder sig under 500 ms.
English: • Inflammation of the lung tissue.
Danish: • Betændelse i lungevævet.
English: Headache, paraesthesia, dysaesthesia, dizziness
Danish: Hovedpine, paræstesi, dysæstesi, svimmelhed
English: - Keep this leaflet and the patient alert card. You may need to read it again.
Danish: - Gem indlægssedlen og patientinformationskortet.
English: If another event of common terminology criteria for adverse events (CTCAE) grade 3 or higher toxicity or prolongation of the ECG QTc interval occurs, dosing with Caprelsa should be at least temporarily stopped and resumed at a reduced dose (c in Table 1) when toxicity has resolved or improved to CTCAE grade 1.
Danish: I tilfælde af yderligere CTCAE-grad 3 eller højere toksicitet eller forlænget QTcinterval i EKG skal indgift af Caprelsa som minimum afbrydes midlertidigt og genoptages med en reduceret dosis (c i tabel 1), når toksiciteten er forsvundet eller bedret til CTCAE-grad 1.
English: Convulsion, clonus, brain oedema
Danish: Kramper, klonus, hjerneødem
English: • Fungal infection.
Danish: • Svampeinfektion.
English: • Decrease in thyroid function.
Danish: • Nedsat funktion af skjoldbruskkirtlen.
English: Haemorrhage
Danish: Nedsat heling
English: The Caprelsa 100 mg tablet is a round, biconvex, white film-coated tablet with ‘Z100' impressed on one side.
Danish: Caprelsa 100 mg tabletten er en rund, bikonveks, hvid filmovertrukket tablet mærket med "Z100" på den ene side.
English: What you need to know before you take Caprelsa
Danish: Det skal du vide før du begynder at tage Caprelsa Tag ikke Caprelsa:
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrationsstede t
English: Caprelsa 300 mg is a white oval-shaped film-coated tablet with “Z300” imprinted on one side.
Danish: Caprelsa 300 mg er en oval, hvid filmovertrukket tablet mærket med ”Z300” på den ene side.
English: • The Patient Leaflet;
Danish: • Indlægsseddel;
English: The Caprelsa 300 mg tablet is an oval-shaped, biconvex, white film-coated tablet with ‘Z300' impressed on one side.
Danish: Caprelsa 300 mg tabletten er en oval, bikonveks, hvid filmovertrukket tablet mærket med "Z300" på den ene side.
English: • If you may become pregnant you must use effective contraception when you are taking Caprelsa and for at least four months after the last dose of Caprelsa.
Danish: Caprelsa, og i mindst fire måneder efter den seneste dosis af Caprelsa.
English: A brain MRI should be performed in any patient presenting with seizures, confusion or altered mental status;
Danish: MR-skanning af hjernen hos alle patienter, der lider af krampeanfald, konfusion eller ændret mental status;
English: • Decreased levels of sodium in your blood.
Danish: • Nedsat niveau af natrium i blodet.
English: NAME OF THE MEDICINAL PRODUCT Caprelsa 100 mg tablets vandetanib
Danish: Caprelsa 100 mg tabletter vandetanib
English: • Visual impairment.
Danish: • Manglende evne til sårheling.
English: INFORMATION IN BRAILLE Caprelsa 300 mg
Danish: BLISTER FOR CAPRELSA 300 mg
English: • Loss of hair from the head or body (alopecia).
Danish: • Hårtab på hovedet eller kroppen.
English: • Boil.
Danish: • Bylder.
English: Uncommon (affects less than 1 in 100 people)
Danish: Ikke almindelig (ses hos mindre end 1 ud af 100 personer):
English: Brain MRI should be performed in any patient presenting with seizures, confusion or altered mental status.
Danish: Der bør udføres en MR-skanning af hjernen hos enhver patient, med krampeanfald, konfusion eller ændret mental status.
English: Dose adjustments in adult patients with MTC
Danish: Dosisjusteringer ved MTC hos voksne patienter
English: If you take more Caprelsa than you should
Danish: Hvis du har taget for meget Caprelsa
English: NAME OF THE MEDICINAL PRODUCT Caprelsa 300 mg tablets vandetanib
Danish: Caprelsa 300 mg tabletter vandetanib
English: INFORMATION IN BRAILLE Caprelsa 100 mg
Danish: BLISTER FOR CAPRELSA 100 mg
English: The starting dose could be reduced to 200 mg in patients with moderate renal impairment; safety and efficacy have however not been established with 200 mg (see section 4.4).
Danish: Sikkerhed og virkning er dog ikke klarlagt for styrken på 200 mg (se pkt.
English: • Combinations contraindicated (see section 4.3): Cisapride, erythromycin intravenous (IV), toremifene, mizolastine, moxifloxacin, arsenic, Class IA and III antiarrhythmics
Danish: ), toremifen, mizolastin, moxifloxacin, arsenik, klasse IA- og III-antiarytmika
English: How to take Caprelsa
Danish: Sådan skal du tage Caprelsa Voksne
English: Caprelsa 300 mg film-coated tablets
Danish: Caprelsa 300 mg filmovertrukne tabletter vandetanib
English: Dose adjustments in paediatric patients with MTC
Danish: Dosisjusteringer ved MTC hos pædiatriske patienter
English: Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Danish: Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irland Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: • Tiredness.
Danish: • Vægttab.
English: • Drowsiness.
Danish: • Træthed.
English: Caprelsa 300 mg tablets Each film-coated tablet contains 300 mg of vandetanib.
Danish: Hver filmovertrukket tablet indeholder 300 mg vandetanib.
English: • Dizziness.
Danish: • Nyresvigt.
English: Caprelsa 100 mg tablets Each film-coated tablet contains 100 mg of vandetanib.
Danish: Hver filmovertrukket tablet indeholder 100 mg vandetanib.
English: Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
Danish: Norge sanofi-aventis Norge AS Tlf: + 47 67 10 71 00
English: Effects on reproduction in paediatric patients treated with vandetanib are not known.
Danish: Der foreligger ingen data om vandetanibs indvirkning på reproduktionen hos pædiatriske patienter.
English: • Fatigue.
Danish: • Udmattelse.
English: • Increased levels of glucose in your blood.
Danish: • Øget blodsukkerniveau (glucose).
English: Vistor hf.
Danish: • Hul i tarmene.
English: • Kidney infection.
Danish: • Nyreinfektion.
English: NAME OF THE MEDICINAL PRODUCT Caprelsa 100 mg film-coated tablets vandetanib
Danish: Caprelsa 100 mg filmovertrukne tabletter vandetanib
English: What Caprelsa is and what it is used for What you need to know before you take Caprelsa How to take Caprelsa
Danish: Det skal du vide, før du begynder at tage Caprelsa Sådan skal du tage Caprelsa Bivirkninger
English: Or
Danish: Øjne
English: • Contact details of the CAPRELSA prescriber.
Danish: Pakningsstørrelser og yderligere oplysninger Caprelsa indeholder
English: • Decreased levels of potassium in your blood.
Danish: • Nedsat niveau af kalium i blodet.
English: Dysuria, hematuria, renal failure, pollakiuria, micturition urgency
Danish: Nyrer og urinveje Proteinuri, nyresten Vandladningsbesvær, hæmaturi, nyresvigt, pollakisuri, imperiøs vandladningstrang
English: What Caprelsa looks like and contents of the pack Caprelsa 100 mg is a white round film-coated tablet with “Z100” imprinted on one side.
Danish: Caprelsa 100 mg er en rund, hvid filmovertrukket tablet mærket med ”Z100” på den ene side.
English: Medicinal products known to prolong QTc interval Vandetanib has been shown to prolong the ECG QTc interval; Torsades de pointes have been uncommonly reported.
Danish: Det er påvist, at vandetanib kan forlænge QTc-intervallet i EKG.
English: Use in children
Danish: Børn
English: • Weight loss.
Danish: • Kraftig vandladningstrang.
English: • Pain.
Danish: • Smerte.
English: • Vandetanib was found not to impair linear growth in clinical trials conducted in children and adolescents;
Danish: • Kliniske studier med børn og unge har vist, at vandetanib ikke hæmmer lineær vækst;
English: Class
Danish: Hjerte
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist straight away.
Danish: Kontakt straks lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: Some of this increase may be due to other risk factors.
Danish: Noget af denne stigning kan skyldes andre risikofaktorer.
English: An excessive increase, however, occurs only in isolated cases.
Danish: En usædvanlig stor forøgelse forekommer imidlertid kun i enkeltstående tilfælde.
English: Date of first authorisation: 12 June 2009 Date of latest renewal: 21 February 2014
Danish: Dato for første markedsføringstilladelse: 12. juni 2009 Dato for sidste fornyelse: 21. februar 2014
English: HIV-infection).
Danish: HIV-infektion).
English: The following additional risks are considered relevant for long-term use:
Danish: Nedenstående yderligere risici anses for relevante i forbindelse med langvarig anvendelse:
English: • They are aged over 55 years with new or recently changed symptoms.
Danish: • de er over 55 år med nye eller nyligt ændrede symptomer.
English: Patients should be instructed to consult a doctor if:
Danish: Patienter bør instrueres i at kontakte lægen, hvis:
English: The increase in gastrin is reversible.
Danish: Øgningen af gastrin er reversibel.
English: Pantoprazole is completely and rapidly absorbed after oral administration.
Danish: Pantoprazol absorberes hurtigt og fuldstændigt efter oral administration.
English: In these cases, malignancy should be excluded.
Danish: I disse tilfælde bør malign sygdom udelukkes.
English: • They have any other serious disease affecting general well-being.
Danish: • de lider af en anden alvorlig sygdom, som generelt påvirker deres velbefindende.
English: The effect is the same whether the active substance is given orally or intravenously.
Danish: Virkningen er den samme, uanset om det aktive stof gives oralt eller intravenøst.
English: The absolute bioavailability from the tablet was found to be about 77%.
Danish: Den absolutte biotilgængelighed for en tablet er omkring 77%.
English: Do not take a double dose to make up for the forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
Danish: Din læge kan beslutte at tage regelmæssige blodprøver for at overvåge dine magnesiumniveauer.
English: The most commonly reported adverse reactions are diarrhoea and headache, both occuring in approximately 1% of patients.
Danish: De hyppigst rapporterede bivirkninger er diaré og hovedpine, som begge forekommer hos ca. 1% af patienterne.
English: You should talk to your doctor if you have been using this product for more than 4 weeks.
Danish: Du skal tale med din læge om det, hvis du har brugt dette produkt i mere end 4 uger.
English: Do not chew or break the tablet.
Danish: Du må ikke tygge eller knuse tabletten.
English: The relevance of this finding to the paediatric population is unclear.
Danish: Relevansen af dette fund for den pædiatriske population er uklar.
English: However, an interaction of pantoprazole with other substances which are metabolised by the same enzyme system cannot be excluded.
Danish: Dog kan interaktion af pantoprazol med andre stoffer, som metaboliseres via det samme enzymsystem, ikke udelukkes.
English: Take your next, normal dose, the next day, at your usual time.
Danish: Tag den næste dosis næste dag til sædvanlig tid.
English: Patients should not take pantoprazole as a preventive medicinal product.
Danish: Patienterne bør ikke tage pantoprazol som et forebyggende lægemiddel.
English: Pantoprazole/metabolites have been identified in human milk.
Danish: Pantoprazol/metabolitter er blevet identificeret i human mælk.
English: Interference with Laboratory Tests
Danish: Interferens med laboratorieprøver
English: Tell your doctor immediately or contact the casualty department at your nearest hospital, if you get any of the following serious side effects.
Danish: Fortæl det straks til lægen eller kontakt skadestuen på det nærmeste hospital, hvis du får nogle af følgende alvorlige bivirkninger.
English: In the case of overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.
Danish: I tilfælde af overdosering med kliniske tegn på forgiftning, bortset fra symptomatisk og understøttende behandling, kan der ikke gives nogle særlige terapeutiske anbefalinger.
English: If you take PANTOLOC Control for longer periods, this may cause additional risks, such as:
Danish: Hvis du tager PANTOLOC Control i længere perioder, kan det medføre yderligere risici i form af:
English: The recommended dose is one tablet a day.
Danish: Den anbefalede dosis er en tablet daglig.
English: Patients should be advised that the tablets are not intended to provide immediate relief.
Danish: Patienterne bør rådgives om, at tabletterne ikke er beregnet til at give øjeblikkelig lindring.
English: HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice.
Danish: HIV-infektion) samtidig med pantoprazole, skal du spørge din læge specifikt om råd.
English: Take the tablet before a meal, at the same time every day.
Danish: Tag tabletten på samme tid hver dag før et måltid.
English: GORD diagnosis in these studies was based on endoscopic assessment, with the exception of one study in which the inclusion of the patients was based on symptomatology alone.
Danish: GORD-diagnosen i disse studier er baseret på endoskopisk vurdering, med undtagelse af et enkelt studie, hvor inkluderingen af patienter alene var baseret på symptomatologi.
English: Take one tablet (20 mg) per day.
Danish: Tag en tablet (20 mg) daglig.
English: There are no adequate data from the use of pantoprazole in pregnant women.
Danish: Der er utilstrækkelige data for anvendelse af pantoprazol til gravide kvinder.
English: Once complete relief of symptoms has occurred, treatment should be discontinued.
Danish: Når fuldstændig symptomlindring er opnået, bør behandlingen ophøre.
English: Distribution Volume of distribution is about 0.15 l/kg and serum protein binding is about 98%.
Danish: Fordeling Fordelingsvolumet er på omkring 0,15 l/kg og serumproteinbindingen er ca. 98%.
English: Povidone K90
Danish: Povidon K90
English: You should not take this medicine if you are pregnant or while-breastfeeding.
Danish: Du skal ikke tage dette lægemiddel hvis du er gravid eller ammer.
English: Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.
Danish: Patienter med risiko for osteoporose skal have behandling i henhold til gældende kliniske retningslinjer, og de skal have et tilstrækkeligt indtag af vitamin D og calcium.
English: Hence it reduces the amount of acid in your stomach.
Danish: Dermed reduceres mængden af syre i din mave.
English: Povidone K25
Danish: Povidon K25
English: The effect of pantoprazole on newborns/infants is unknown.
Danish: Pantoprazols virkning på nyfødte/spædbørn kendes ikke.
English: Studies in animals have shown reproductive toxicity.
Danish: Dyrestudier har påvist reproduktionstoksicitet.
English: If possible take your medicine and this leaflet with you.
Danish: Tag om muligt din medicin og denne indlægsseddel med.
English: Patients should be warned about additional risks with long-term use of the medicinal products and the need for prescription and regular surveillance should be emphasized.
Danish: Patienter skal advares om yderligere risici ved langvarig anvendelse af de medicinske produkter, og behovet for ordination og regelmæssig kontrol skal understreges.
English: Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test.
Danish: Patienterne bør konsultere deres læge inden de tager dette lægemiddel, hvis de skal have foretaget en endoskopi eller urea udåndingstest.
English: Other side effects include: - Common (may affect up to 1 in 10 people): Benign polyps in the stomach
Danish: Andre bivirkninger omfatter: - Almindelig (kan påvirke op til 1 ud af 10 personer): Godartede polypper i maven.
English: Approximately 5% of patients can be expected to experience adverse reactions.
Danish: Det forventes, at der i gennemsnit er 5% af patienterne, som oplever bivirkninger.
English: Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood.
Danish: Lave magnesiumniveauer kan også medføre en reduktion af kalium- eller calciumniveauerne i blodet.