natgillin/translations-raw huggingface dataset:
- hvis du tager anden medicin eller andre stoffer, som øger mængden af kalium i dit blod (f. eks.
70 Take special care with Exforge − if you have been sick (vomiting or diarrhoea). − if you are taking diuretics (a type of medicine also called “ water tablets” which increases the amount of urine you produce). − if you are taking other medicines or substances that increase the level of potassium in your blood (e. g. some types of diuretics, potassium supplements or salt substitutes containing potassium). − if you have liver or kidney problems. − if you have a condition affecting the renal glands called “ primary hyperaldosteronism”. − if you have had heart failure. − if your doctor has told you that you have a narrowing of the valves in your heart (called “ aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “ obstructive hypertrophic cardiomyopathy”).
74 Hvis du bliver gravid, mens du er i behandling med Exforge, skal du konsultere din læge med det samme.
If you become pregnant during therapy with Exforge, please inform and see your doctor without delay.
Giv din læge besked, hvis du ammer.
71 Tell your doctor if you are breast-feeding.
76 6.
6.
indeholder 5 mg amlodipin og 160 mg valsartan.
Each tablet contains 5 mg amlodipine and 160 mg valsartan.
magnesiumstearat; hypromellose; macrogol 4000; talcum; titandioxid (E171); gul jernoxid (E172).
73 − The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
Exforges udseende og pakningstørrelse Exforge 5 mg/ 160 mg tabletter er ovale og mørkegule, præget med ” NVR ” på den ene side og ” ECE ” på den anden side.
What Exforge looks like and contents of the pack Exforge 5 mg/ 160 mg tablets are oval and dark yellow “ NVR” on one side and “ ECE” on the other side.
77 Ελλάδα Novartis (Hellas) A. E. B. E.
Ελλάδα Novartis (Hellas) A. E. B. E.
- hvis du tager anden medicin eller andre stoffer, som øger mængden af kalium i dit blod (f. eks.
Take special care with Exforge − if you have been sick (vomiting or diarrhoea).
nogle typer diuretika, kaliumtilskud eller salterstatninger, som indeholder kalium).
76 − if you are taking diuretics (a type of medicine also called “ water tablets” which increases the amount of urine you produce). − if you are taking other medicines or substances that increase the level of potassium in your blood (e. g. some types of diuretics, potassium supplements or salt substitutes containing potassium). − if you have liver or kidney problems. − if you have a condition affecting the renal glands called “ primary hyperaldosteronism”. − if you have had heart failure. − if your doctor has told you that you have a narrowing of the valves in your heart (called “ aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “ obstructive hypertrophic cardiomyopathy”).
80 Hvis du bliver gravid, mens du er i behandling med Exforge, skal du konsultere din læge med det samme.
If you become pregnant during therapy with Exforge, please inform and see your doctor without delay.
Spørg din læge eller apoteket til råds, før du tager nogen form for medicin.
77 Ask your doctor or pharmacist for advice before taking any medicine.
81 hurtigt hjerteslag inklusive hjertebanken; svimmelhed ved skift til stående stilling; hoste; diarré; forstoppelse; hududslæt; rødme af huden; hævelse af led, rygsmerter; ledsmerter.
Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness of the hands or feet; vertigo; fast heart beat including palpitations; dizziness on standing up; cough; diarrhoea; constipation; skin rash, redness of the skin; joint swelling, back pain; pain in joints.
Hvis nogle af disse bivirkninger påvirker dig i alvorlig grad, skal du tale med din læge.
78 If any of these affect you severely, tell your doctor.
82 6.
6.
Exforges udseende og pakningstørrelse Exforge 10 mg/ 160 mg tabletter er ovale og lysegule, præget med ” NVR ” på den ene side og ” UIC ” på den anden side.
79 What Exforge looks like and contents of the pack Exforge 10 mg/ 160 mg tablets are oval and light yellow with “ NVR” on one side and “ UIC” on the other side.
83 Ελλάδα Novartis (Hellas) A. E. B. E.
Ελλάδα Novartis (Hellas) A. E. B. E.
BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET TIL IMPLEMENTERING I MEDLEMSLANDENE
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET TIL IMPLEMENTERING I MEDLEMSLANDENE
1 • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
I deres medlemsland skal medlemslandene sikre at:
The Member States shall ensure that in their Member State:
Produktinformation Information til lægen om Exjade (brochure og pocket card) Informationspakke til patienten
Product information Physician information about Exjade (brochure and pocket card) Patient information pack
• Nødvendigheden af at monitorere serum- ferritin månedligt
• The need to monitor serum ferritin monthly
Voksne: > 33% over baseline og kreatinin- clearance < LLN (90 ml/ min) Børn: enten > ULN eller kreatinin- clearance falder til < LLN
• That Exjade causes rises in serum creatinine in some patients o The need to monitor serum creatinine • On two occasions prior to initiation of treatment • Every week during the first month of initiation of treatment or after modification of therapy • Monthly thereafter o The need to reduce by 10 mg/ kg the dose if serum creatinine rises: • Adults: > 33% above baseline and creatinine clearance< LLN (90 ml/min) • Paediatrics: either > ULN or creatinine clearance falls to < LLN o The need to interrupt treatment if serum creatinine rises: • Adults and paediatrics: > 33% above baseline or creatinine clearance < LLN (90 ml/min) o The need to consider renal biopsy: • When serum creatinine is elevated and if another abnormality has been detected (eg. proteinuria, signs of Fanconi’s Syndrome).
• Vigtigheden af at måle kreatinin- clearance • Kort oversigt over metoder til måling af kreatinin- clearance • At stigninger i transaminaser forekommer hos patienter, der er blevet behandlet med Exjade o Nødvendigheden af at foretage leverfunktionstests før udskrivning, og derefter med månedlige intervaller eller hyppigere hvis klinisk indiceret o Ikke at udskrive Exjade til patienter med allerede eksisterende alvorlig leversygdom o Nødvendigheden af at afbryde behandlingen, hvis der ses vedvarende og progressiv stigning i leverenzym. • Nødvendigheden af årligt at teste hørelsen og synet
• The importance of measuring creatinine clearance • Brief overview of methods of measuring creatinine clearance • That rises in serum transaminases occur in patients treated with Exjade o The need for liver function tests prior to prescription, then at monthly intervals or more often if clinically indicated o Not to prescribe to patients with pre-existing severe hepatic disease o The need to interrupt treatment if persistent or progressive increase in liver enzymes were noted. • The need for annual auditory and ophthalmic testing • The need for a guidance table highlighting pre-treatment measurements of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin, such as:
• Nødvendigheden af et vejledende skema der fremhæver målinger før behandling af serum - kreatinin, kreatinin- clearance, proteinuri, leverenzymer, ferritin, som f. eks.:
Before initiating treatment,
Før påbegyndelse af behandling Serum- kreatinin ved Dag X Serum- kreatinin ved Dag Y X og Y er dagene (skal fastsættes), hvor målingerne
Serum creatinine at Day - X Serum creatinine at Day - Y
Værdi 1 Værdi 2 før behandling skal udføres.
Value 1 Value 2
• Uddannelsesprogrammet bør opfordre læger til at indrapportere alvorlige utilsigtede hændelser og visse udvalgte utilsigtede hændelser som nedenfor: • Alle alvorlige bivirkninger
• The educational programme should prompt doctors to report serious ADRs and certain selected ADRs as below: • All serious ADRs • Persistent and progressive increase in hepatic enzymes • Increase in serum creatinine levels (> 33% above baseline) or decrease of creatinine clearance (< 90 ml/ min).
Vedholdende og progressive stigninger i leverenzymer Stigninger i serum- kreatinin (> 33% over baseline) eller fald i kreatinin- clearance (< 90 ml/ kg)
Significant changes found in auditory or ophthalmological testing Gallstones Unexpected ADRs according to the SPC.
• • •
o o
Signifikante ændringer fundet ved test af hørelse eller syn Galdesten Uventede bivirkninger i henhold til SPC
Patient b ooklet where the physician can record the results of the above along with the dose of Exjade
Informationspakken til patienter bør indeholde følgende: o Indlægssedlen o Information om nødvendigheden af regelmæssig monitorering af serum- kreatinin, kreatinin- clearance, proteinuri, leverenzymer, ferritin, og hvornår denne skal udføres o Information om, at man vil overveje at udføre nyrebiopsi, hvis der opstår signifikante nyreabnormaliteter o Patientfolder hvor lægen kan notere resultaterne af ovenstående sammen med Exjade - dosis o Besøgskort til datoer for undersøgelser
Reminder card for dates of tests
Hvis du ønsker yderligere oplysninger om grundlaget for CHMP’ s anbefalinger, kan du læse den faglige drøftelse (der ligeledes er en del af denne EPAR).
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Exjade er et lægemiddel, som indeholder det aktive stof deferasirox.
Exjade is a medicine that contains the active substance deferasirox.
Det fås som runde, hvide dispergible tabletter, som blandes med væske og bliver til en suspension, som patienten kan drikke.
It is available as round, white dispersible tablets that are mixed with a liquid to make up a suspension that the patient can drink.
Hver tablet indeholder 125 mg, 250 mg eller 500 mg deferasirox.
Each tablet contains 125 mg, 250 mg or 500 mg of deferasirox.
Beta- thalassæmi er en arvelig sygdom, som kræver behandling med hyppige blodtransfusioner.
Exjade is used to treat a condition called chronic iron overload (an excess of iron in the body), which results from having repeated blood transfusions. • Exjade is used to reduce the amount of iron in the body of patients from six years of age who suffer from an inherited disease called beta thalassaemia major and who receive frequent blood transfusions to treat it.
Patienter med svær beta- thalassæmi producerer ikke nok hæmoglobin (det protein i røde blodlegemer, der transporterer ilt rundt i kroppen) og må derfor regelmæssigt have blodtransfusioner.
Patients suffering from beta thalassaemia major are unable to make enough haemoglobin (the protein found in red blood cells that carries oxygen around the body), and they need regular blood transfusions.
Dette gælder således patienter med andre former for blodmangel, børn fra to til fem år, og patienter, der har svær beta- thalassæmi, men som får mindre hyppige blodtransfusioner.
Frequent transfusions are defined as at least 7 ml of packed (concentrated) red blood cells per kilogram body weight in a month. • Exjade is also used when deferoxamine (another medicine used to treat iron overload) cannot be used or is inadequate, in patients who suffer from other types of anaemia, in children aged from two to five years, and in patients with beta thalassaemia major who receive less frequent transfusions.
Exjade blev udpeget som "lægemiddel til sjældne sygdomme" den 13. marts 2002.
Because the number of patients with chronic iron overload is low, the disease is considered ‘ rare’, and Exjade was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 13 March 2002.
Behandlingen med Exjade bør indledes og overvåges af en læge med erfaring i behandling af kronisk jernophobning forårsaget af hyppige transfusioner.
Treatment with Exjade should be started and supervised by a doctor who is experienced in the treatment of chronic iron overload due to frequent transfusions.
Kun patienter uden nyresygdomme kan behandles med Exjade.
Only patients who have no problems with their kidneys can be treated with Exjade.
Behandlingen påbegyndes, når patienten har fået omkring 100 ml pakkede røde blodlegemer pr. kilogram kropsvægt, eller når der er tegn på jernophobning (dvs. når blodet indeholder over 1 mg/ l ferritin, som er det protein, der opbevarer jern i kroppen).
The treatment starts once the patient has received about 100 ml of packed red blood cells per kilogram body weight, or once there are signs of iron overload (when the levels in the blood of ferritin, the protein in the body that stores iron, are over 1 mg per litre).
Behandlingen indledes sædvanligvis med en dosis på 20 mg/ kg kropsvægt.
The treatment usually starts using a dose of 20 mg per kilogram body weight.
En startdosis på 10 mg eller 30 mg/ kg
Starting doses of 10 or 30 mg/ kg can also be used, depending on the frequency of the patient ’ s transfusions.
Reproduction is authorised provided the source is acknowledged. kan også anvendes, afhængigt af hyppigheden af patientens transfusioner.
Reproduction is authorised provided the source is acknowledged.
Exjade skal tages en gang dagligt, helst samme klokkeslæt hver dag, på tom mave (mindst 30 minutter inden fødeindtagelse).
Exjade is taken every day, preferably at the same time each day, on an empty stomach (at least 30 minutes before food).
Ud fra patientens kropsvægt beregner man, hvor mange tabletter af de forskellige styrker, der tilsammen udgør patientens dosis.
The number of tablets of each strength that make up a dose is calculated based on the patient’ s weight.
Tabletterne udrøres i et glas vand eller frugtjuice, så der dannes en suspension, patienten skal drikke.
The tablets are dispersed by stirring them in a glass of water or fruit juice to make a suspension for the patient to drink.
Når man får gentagne transfusioner for at rette op på blodmangel, vil de transfunderede blodlegemer tilføre jern til kroppen.
When patients receive repeated transfusions to correct anaemia, the transfused red cells bring iron into the body.
Da kroppen imidlertid ikke kan fjerne overskydende jern selv, kan jernet blive ophobet og med tiden beskadige vitale organer som hjerte og lever.
As the body does not have a natural way of removing excess iron, it can build up and, over time, damage important organs such as the heart or liver.
Det aktive stof i Exjade, deferasirox, er et "jernkelaterende" stof.
The active substance in Exjade, deferasirox, is an ‘ iron chelator’.
Det bindes til jernet i kroppen og danner derved en forbindelse kaldet et "kelat", som kroppen kan udskille, hovedsagelig i afføringen.
It binds to iron in the body to form a compound called a ‘ chelate ’ that can be excreted by the body, mainly in the stools.
Dette medvirker til at afhjælpe jernophobningen og forhindre skade på grund af overskud af jern.
This helps to correct the iron overload and prevent damage due to excess iron.
Virkningerne af Exjade blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Exjade were first tested in experimental models before being studied in humans.
I hovedundersøgelsen blev virkningen af Exjade sammenlignet med virkningen af deferoxamin hos 591 patienter med svær beta- thalassæmi.
The main study of effectiveness compared Exjade with deferoxamine in 591 patients with beta thalassaemia major.
Ca. halvdelen af patienterne var under 16 år, og 56 var under seks år.
About half of the patients were under the age of 16, and 56 were less than six years old.
Dette skyldes, at mens Exjade gives oralt, gives deferoxamin ved subkutan indsprøjtning (meget langsom infusion under huden) natten over.
The doctor and patients knew which medicine they were using because Exjade is given by mouth but deferoxamine is given by subcutaneous infusion (very slow injection under the skin) overnight.
Virkningen blev målt ved at undersøge jernindholdet i leveren før og efter et års behandling med de to lægemidler.
The effectiveness was measured by looking at the level of iron contained in the liver before and after one year of treatment with the medicines.
I en yderligere undersøgelse så man nærmere på Exjades virkning hos 184 patienter, som ikke kunne behandles med deferoxamin, herunder patienter med svær beta- thalassæmi og andre typer anæmi.
An additional study looked at the effectiveness of Exjade in 184 patients who could not be treated with deferoxamine, including patients with beta thalassaemia major and with other types of anaemia.
Ved hovedundersøgelsens slutning havde behandlingen haft tilstrækkelig virkning hos 53% af de patienter, der fik Exjade, sammenlignet med 66% af de patienter, der fik deferoxamin.
At the end of the main study, 53% of the patients receiving Exjade had shown a sufficient response to treatment, compared with 66% of the patients receiving deferoxamine.
Dog havde de to lægemidler samme virkning, når man specielt ser på de 381 patienter, der havde særlig højt indhold af jern i leveren ved undersøgelsens begyndelse og som havde fået Exjade eller deferoxamin i doser svarende til hinanden.
However, when looking at the 381 patients who had particularly high levels of iron in their liver at the beginning of the study and who received comparable amounts of Exjade or deferoxamine, the two medicines were as effective as each other.
Antallet af patienter under seks år var ikke tilstrækkeligt til, at Exjades sikkerhed og virkning kunne påvises for denne aldersgruppe.
There were too few patients in this study aged below six years to demonstrate the safety and effectiveness of Exjade in this age group.
I den yderligere undersøgelse havde over halvdelen af de patienter, som ikke kunne behandles med deferoxamin, responderet på behandlingen med Exjade efter et år, herunder patienterne på mellem to og fem år.
In the additional study, more than half of the patients who could not be treated with deferoxamine had responded to treatment with Exjade after a year, including patients aged between two and five years.
Den mest almindelige bivirkning ved Exjade (som ses hos flere end 1 ud af 10 patienter) er forhøjede kreatininniveauer (et tegn på nyreproblemer).
The most common side effect with Exjade (seen in more than 1 patient in 10) is increased blood creatinine (a marker of kidney problems).
Den fuldstændige liste over de indberettede bivirkninger for Exjade fremgår af indlægssedlen.
For the full list of all side effects reported with Exjade, see the Package Leaflet.
Exjade må ikke anvendes af patienter, der kan være overfølsomme (allergiske) over for deferasirox eller andre af indholdsstofferne, eller af patienter, hvis kreatininclearance (kreatininclearance er et mål for nyrernes evne til at fjerne kreatinin fra blodet) er under 60 ml/ minut.
Exjade should not be used in people who may be hypersensitive (allergic) to deferasirox or any of the other ingredients, or in people whose creatinine clearance (a measure of the ability of the kidney to remove creatinine from the blood) is below 60 ml per minute.
Det må ikke anvendes sammen med andre jernkelaterende midler.
It should not be used in combination with other iron chelators.
Det er meget vigtigt, at patientens nyrer og lever kontrolleres ved hjælp af blodprøver, både inden behandlingen med Exjade indledes og regelmæssigt under behandlingen.
It is very important that the patient ’ s kidneys and liver are checked with blood tests before treatment with Exjade is started, and regularly during treatment.
Dosen skal nedsættes eller behandlingen skal afbrydes, hvis patienten får nyre - eller leverproblemer.
The dose should be reduced or treatment interrupted if a patient develops kidney or liver problems.
Det anbefales ikke at anvende Exjade til patienter med leversygdomme, da det ikke er blevet undersøgt hos denne gruppe.
Exjade is not recommended for patients with severe liver problems as it has not been tested in this group.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Exjade er større end risiciene ved behandling af kronisk jernophobning som følge af gentagne blodtransfusioner hos
The Committee for Medicinal Products for Human Use (CHMP) decided that Exjade’ s benefits are greater than its risks for the treatment of chronic iron overload due to frequent blood transfusions in patients with beta thalassaemia major, and due to blood transfusions when deferoxamine therapy is contraindicated or inadequate.
2/ 3 patienter med svær beta- thalassæmi, når behandling med deferoxamin ikke kan anvendes eller ikke virker tilstrækkeligt.
2/ 3 Which measures are being taken to ensure the safe use of Exjade?
Udvalget anbefalede udstedelse af markedsføringstilladelse for Exjade.
The company responsible for making Exjade available must prepare an education pack for doctors, which is distributed whenever the medicine is launched.
Formålet med pakken er at sikre, at lægerne ved ordinering af lægemidlet er klar over, at det er nødvendigt at overvåge patientens helbred, specielt nyrefunktionen.
This pack will ensure that doctors know about the need to monitor the patient ’ s health, especially kidney function, when they prescribe the medicine.
Virksomheden skal udarbejde en tilsvarende informationspakke til patienterne.
The company will also prepare a similar pack for patients.
Andre oplysninger om Exjade Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Exjade til Novartis Europharm Limited den 28. august 2006.
Other information about Exjade The European Commission granted a marketing authorisation valid throughout the European Union for Exjade to Novartis Europharm Limited on 28 August 2006.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme for Exjade kan ses her.
The summary of opinion of the Committee for Orphan Medicinal Products for Exjade is available here.
Den fuldstændige EPAR for Exjade findes her
The full EPAR for Exjade can be found here.
84 tabletter
Invented name
Dispergibel tablet
Pharmaceutical Form
Dispergibel tablet
Route of Administration
84 tabletter
Packaging
28 tabletter
Package size
EU/ 1/ 06/ 356/ 006
EU/ 1/ 06/ 356/ 001 EU/ 1/ 06/ 356/ 002 EU/ 1/ 06/ 356/ 003 EU/ 1/ 06/ 356/ 004 EU/ 1/ 06/ 356/ 005 EU/ 1/ 06/ 356/ 006 EU/ 1/ 06/ 356/ 007 EU/ 1/ 06/ 356/ 008 EU/ 1/ 06/ 356/ 009
PVC/ PE/ PCDC/ Aluminium blisterpakninger
Exjade Exjade Exjade Exjade Exjade Exjade Exjade Exjade Exjade
125 mg
125 mg 125 mg 250 mg 250 mg 500 mg 500 mg 125 mg 250 mg 500 mg
Dispergibel tablet
Dispersible tablet Dispersible tablet Dispersible tablet Dispersible tablet Dispersible tablet Dispersible tablet Dispersible tablet Dispersible tablet Dispersible tablet
PVC/ PE/ PCDC/ Aluminium blisterpakninger
Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu)
PVC/ PE/ PCDC/ Aluminium blisterpakninger
28 tablets 84 tablets 28 tablets 84 tablets 28 tablets 84 tablets 252 tablets 252 tablets 252 tablets
Dette præparat indeholder lactose.
This product contains lactose.
Råhvide, runde, flade tabletter med skrå kanter og prægning (NVR på den ene side og J 125 på den anden).
Off-white, round, flat tablets with bevelled edges and imprints (NVR on one face and J 125 on the other).
EXJADE er indiceret til behandling af kronisk jernophobning forårsaget af hyppige blodtransfusioner (≥ 7 ml/ kg/ måned pakkede røde blodceller) hos patienter i alderen 6 år og ældre, der har beta - thallasæmi major.
EXJADE is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥ 7 ml/ kg/ month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.