FrancophonIA/ELRC3.0 huggingface dataset:
English: Zerit 30 mg hard capsules Each hard capsule contains 30 mg of stavudine.
Danish: Hver hård kapsel indeholder 30 mg stavudin.
English: The active substance is stavudine (40 mg).
Danish: Zerit indeholder: - Aktivt stof: stavudin (40 mg).
English: INFORMATION IN BRAILLE Outer carton: Zerit 40 mg
Danish: INFORMATION I BRAILLESKRIFT Ydre karton: Zerit 40 mg
English: INFORMATION IN BRAILLE Outer carton: Zerit 30 mg
Danish: INFORMATION I BRAILLESKRIFT Ydre karton: Zerit 30 mg
English: Zerit 20 mg hard capsules Stavudine
Danish: Zerit 20 mg hårde kapsler Stavudin
English: INFORMATION IN BRAILLE Outer carton: Zerit 20 mg
Danish: INFORMATION I BRAILLESKRIFT Ydre karton: Zerit 20 mg
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Du skal diskutere beslutningen om at stoppe behandlingen med din læge Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: The active substance is stavudine (30 mg).
Danish: Zerit indeholder: - Aktivt stof: stavudin (30 mg).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 15 mg stavudine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 15 mg stavudin.
English: NAME OF THE MEDICINAL PRODUCT Zerit 20 mg hard capsules
Danish: LÆGEMIDLETS NAVN Zerit 20 mg hårde kapsler Stavudin
English: 15 mg twice daily
Danish: 30 mg 2 gange dagligt.
English: Zerit 40 mg hard capsules Stavudine
Danish: Zerit 40 mg hårde kapsler Stavudin
English: Zerit 30 mg hard capsules Stavudine
Danish: Zerit 30 mg hårde kapsler Stavudin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 20 mg stavudine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 20 mg stavudin.
English: common: fatigue uncommon: asthenia
Danish: Almindelig: træthed Ikke almindelig: asteni
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 40 mg stavudine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 40 mg stavudin.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/008
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/96/009/008
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 30 mg stavudine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 30 mg stavudin.
English: Zerit 20 mg hard capsules are supplied in blister packs of 56 hard capsules or bottles of 60 hard capsules.
Danish: Zerit 20 mg hårde kapsler leveres i blisterpakninger med 56 hårde kapsler eller glas med 60 hårde kapsler.
English: Zerit contains sucrose and preservatives
Danish: Sort prægeblæk, der indeholder Shellac
English: NAME OF THE MEDICINAL PRODUCT Zerit 15 mg hard capsules
Danish: LÆGEMIDLETS NAVN Zerit 15 mg hårde kapsler Stavudin
English: NAME OF THE MEDICINAL PRODUCT Zerit 30 mg hard capsules
Danish: LÆGEMIDLETS NAVN Zerit 30 mg hårde kapsler Stavudin
English: Zerit 15 mg hard capsules are supplied in blister packs of 56 hard capsules or bottles of 60 hard capsules.
Danish: Zerit 15 mg hårde kapsler leveres i blisterpakninger med 56 hårde kapsler eller glas med 60 hårde kapsler.
English: Lipoatrophy: stavudine has been shown to cause loss of subcutaneous fat, which is most evident in the face, limbs and buttocks.
Danish: Lipoatrofi: Det er vist, at stavudin medfører tab af subkutant fedt.
English: Titanium dioxide (E171)
Danish: Jernoxid farvestof (E172) Kolloid silica Natriumlaurilsulfat Titandioxid (E171)
English: Zerit 40 mg hard capsules are supplied in blister packs of 56 hard capsules or bottles of 60 hard capsules.
Danish: Zerit 40 mg hårde kapsler leveres i blisterpakninger med 56 hårde kapsler eller glas med 60 hårde kapsler.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/96/009/007
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/96/009/005
English: Zerit 30 mg hard capsules are supplied in blister packs of 56 hard capsules or bottles of 60 hard capsules.
Danish: Zerit 30 mg hårde kapsler leveres i blisterpakninger med 56 hårde kapsler eller glas med 60 hårde kapsler.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/96/009/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/006
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/96/009/006
English: NAME OF THE MEDICINAL PRODUCT Zerit 40 mg hard capsules
Danish: LÆGEMIDLETS NAVN Zerit 40 mg hårde kapsler Stavudin
English: Tell your doctor if you are taking any of the following medicines, as undesirable interactions may occur:
Danish: Fortæl det til lægen, hvis du tager en eller flere af følgende typer medicin, da der kan forekomme uønskede interaktioner: zidovudin til behandling af hiv-infektion doxorubicin til behandling af kræft ribavirin til behandling af leverbetændelse type C
English: The activity of stavudine is also affected by multi-drug resistance associated mutations such as Q151M.
Danish: Aktiviteten af stavudin påvirkes også af multiresistensassocierede mutationer såsom Q151 M. Ydermere er der blevet rapporteret om K65R hos patienter, der fik stavudin/didanosin eller stavudin/lamivudin, men ikke hos patienter, der fik stavudinmonoterapi.
English: Potassium Hydroxide
Danish: Kapselindhold Lactose
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/96/009/003
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/009
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/96/009/009
English: Stavudine
Danish: Sorbinsyre
English: This summary was last updated in 05-2014.
Danish: Dette sammendrag blev senest ajourført i 05-2014.
English: The recommended dose is one tablet taken twice a day.
Danish: Den anbefalede dosis er én tablet to gange dagligt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vokanamet on 23 April 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vokanamet den 23. april 2014.
English: Vokanamet must not be used in:
Danish: Vokanamet må ikke anvendes til:
English: Other information about Vokanamet
Danish: Andre oplysninger om Vokanamet
English: This is a summary of the European public assessment report (EPAR) for Vokanamet.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vokanamet.
English: The full EPAR and risk management plan summary for Vokanamet can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Vokanamet findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The dose of canagliflozin can then be increased if needed.
Danish: Derefter kan dosen af canagliflozin sættes op, hvis det er nødvendigt.
English: A risk management plan has been developed to ensure that Vokanamet is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Vokanamet anvendes så sikkert som muligt.
English: Vokanamet contains two different active substances, which work in different ways:
Danish: Vokanamet indeholder to forskellige aktive stoffer, der virker på hver sin måde:
English: It also leads to weight loss, which is considered beneficial in patients with diabetes.
Danish: Det giver desuden vægttab, der anses for gavnligt hos diabetespatienter.
English: What is Vokanamet and what is it used for?
Danish: Hvad er Vokanamet, og hvad anvendes det til?
English: Canagliflozin as separate tablets has been authorised in the EU under the brand name Invokana since 15 November 2013.
Danish: Canagliflozin har været godkendt i EU som separate tabletter under handelsnavnet Invokana siden den 15. november 2013.
English: What measures are being taken to ensure the safe and effective use of Vokanamet?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vokanamet?
English: The tablet strength depends on the patient's treatment before starting Vokanamet.
Danish: Tabletstyrken afhænger af, hvilken behandling patienten har modtaget før behandlingen med Vokanamet.
English: Why is Vokanamet approved?
Danish: Hvorfor blev Vokanamet godkendt?
English: It is not intended to provide practical advice on how to use Vokanamet.
Danish: Det er ikke en praktisk vejledning i, hvordan Vokanamet bør anvendes.
English: Concerning its safety, the CHMP considered that the side effects seen with Vokanamet are acceptable and can be managed in clinical practice.
Danish: Vedrørende sikkerheden fandt CHMP, at bivirkningerne med Vokanamet, er acceptable og kan behandles i klinisk praksis.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vokanamet, 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 Vokanamet, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vokanamet's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Vokanamet opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What are the risks associated with Vokanamet?
Danish: Hvilke risici er der forbundet med Vokanamet?
English: Vokanamet is available as tablets containing canagliflozin and metformin in various strengths (50/850 mg, 150/850 mg, 50/1000 mg and 150/1000 mg) and can only be obtained with a prescription.
Danish: Vokanamet leveres som tabletter, der indeholder canagliflozin og metformin i forskellige styrker (50/850 mg, 150/850 mg, 50/1000 mg og 150/1000 mg).
English: • patients with diabetic ketoacidosis or pre-coma (dangerous complications of diabetes),
Danish: • patienter med diabetisk ketoacidose eller prækoma (farlige komplikationer af diabetes)
English: Vokanamet can also be used to replace canagliflozin and metformin given separately.
Danish: Vokanamet kan derudover bruges som erstatning for canagliflozin og metformin givet hver for sig.
English: For more information about treatment with Vokanamet, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Vokanamet, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Patients should start Vokanamet at a strength that provides 50 mg canagliflozin and the dose of metformin they were previously taking (or a close approximation of it).
Danish: Patienten skal begynde med Vokanamet i en styrke, der giver 50 mg canagliflozin og den dosis metformin, patienten fik i forvejen (eller den, der er tættest på).
English: • patients who have liver impairment or are suffering from alcoholism or are intoxicated.
Danish: • patienter med nedsat leverfunktion, eller som lider af alkoholisme eller er berusede.
English: Vokanamet is a diabetes medicine that contains the active substances canagliflozin and metformin.
Danish: Vokanamet er et lægemiddel mod diabetes, der indeholder de aktive stoffer canagliflozin og metformin.
English: • Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Danish: • Metformin virker hovedsagelig ved at hæmme sukkerproduktionen og mindske sukkeroptagelsen fra tarmen.
English: The CHMP also noted that giving the combination of canagliflozin and metformin as a single tablet could provide an additional treatment option for patients with type 2 diabetes, and may improve adherence to treatment.
Danish: CHMP bemærkede derudover, at kombinationen af canagliflozin og metformin i én enkelt tablet kan betyde en ekstra behandlingsmulighed for patienter med type 2-diabetes og kan gøre det lettere for dem at følge behandlingen.
English: When Vokanamet is used as an add-on to insulin or medicines that stimulate the secretion of insulin (e.g. sulphonylureas) the dose of these other medicines may need to be reduced to lower the risk of the patient's blood glucose becoming too low.
Danish: Når Vokanamet bruges som tillægsbehandling til insulin eller lægemidler, der stimulerer insulinudskillelsen (f.eks. sulfonylurinstoffer), kan det være nødvendigt at bruge mindre af disse andre lægemidler, for at blodsukkeret ikke skal blive for lavt.
English: Type-2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Danish: Type 2-diabetes er en tilstand, hvor bugspytkirtlen ikke producerer nok insulin til at regulere blodsukkeret, eller hvor kroppen ikke kan udnytte insulinet tilstrækkeligt.
English: As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes.
Danish: Tilsammen nedsætter de to aktive stoffer blodsukkeret og forbedrer derved reguleringen af type 2-diabetes.
English: The most common side effects with Vokanamet (which may affect more than 1 in 10 people) are hypoglycaemia (low blood glucose levels) when used in combination with insulin or a sulphonylurea and vulvovaginal candidiasis (thrush, a fungal infection of the female genital area caused by Candida).
Danish: De hyppigste bivirkninger ved Vokanamet (som optræder hos mere end 1 ud af 10 patienter), er for lavt blodsukker (hypoglykæmi), når det bruges sammen med insulin eller et sulfonylurinstof, og trøske i skeden og på venusbjerget (vulvovaginal candidiasis, en svampeinfektion med Candida).
English: • patients with moderately or severely reduced kidney function or with severe conditions that could affect the kidneys such as dehydration or severe infection.
Danish: • patienter med middelsvært eller svært nedsat nyrefunktion eller med svære tilstande, der kan ændre nyrefunktionen, såsom væskemangel (dehydrering) eller svær infektion
English: For practical information about using Vokanamet, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Vokanamet, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: SGLT2 absorbs glucose back into the bloodstream as the blood is filtered in the kidneys.
Danish: SGLT2 transporterer sukker tilbage fra urinen til blodbanen, når blodet filtreres i nyrerne.
English: The benefits of metformin are well established and the added advantage of adding canagliflozin to metformin to control blood sugar has been shown in the studies.
Danish: Fordelene ved metformin er velkendt, og undersøgelserne viser, at der er ekstra fordel ved at tilføje canagliflozin til metformin for at regulere blodsukkeret.
English: Canagliflozin was also studied as an add-on treatment in patients who were taking insulin alone, or insulin in combination with other diabetes medicines including metformin and in patients who were taking a sulphonylurea.
Danish: Canagliflozin blev undersøgt som tillægsbehandling hos patienter, der kun fik insulin, eller som fik insulin kombineret med andre diabeteslægemidler, herunder metformin, og hos patienter, der fik et sulfonylurinstof.
English: • patients with a condition that could lead to body tissues being deprived of oxygen (e.g. heart or respiratory failure)
Danish: • patienter med en tilstand, der kan give iltmangel i vævene (f.eks. hjertesvigt eller vejrtrækningssvigt)
English: Three further studies evaluated canagliflozin as an add-on to combined treatment with metformin and either a sulphonylurea or pioglitazone.
Danish: I tre andre undersøgelser blev canagliflozin vurderet som tillægsbehandling til metformin kombineret enten med et sulfonylurinstof eller pioglitazon.
English: The benefits of canagliflozin used in combination with metformin have been shown in several main studies that were evaluated at the time of the authorisation of Invokana.
Danish: Fordelene ved at bruge canagliflozin sammen med metformin er blevet påvist i flere hovedundersøgelser.
English: How is Vokanamet used?
Danish: Hvordan anvendes Vokanamet?
English: What benefits of Vokanamet have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Vokanamet?
English: • canagliflozin works by blocking a protein in the kidneys called sodium glucose co-transporter 2
Danish: • Canagliflozin virker ved at blokere proteinet natrium-glukose-kotransportør 2 (SGLT2) i nyrerne.
English: How does Vokanamet work?
Danish: Hvordan virker Vokanamet?
English: It is used, together with diet and exercise, to control the blood glucose (sugar) levels in adults with type 2 diabetes whose disease is not satisfactorily controlled with metformin alone, or in combination with other diabetes medicines, including insulin, when these medicines together with metformin are not providing adequate control of the diabetes.
Danish: Det bruges sammen med diæt og motion til at regulere blodsukkeret (glukose) hos voksne med type 2diabetes, når sygdommen ikke kan reguleres tilfredsstillende med metformin alene.
English: Adding canagliflozin to treatment was shown to be effective at reducing HbA1c compared with placebo by 0.65 to 0.73 points after 18 weeks in patients receiving insulin and by 0.74 to 0.83 points in patients receiving a sulphonylurea.
Danish: 18 ugers tillægsbehandling med canagliflozin gav en 0,65-0,73 procentpoint større nedsættelse af HbA1c end placebo hos patienter, der fik insulin, og 0,74-0,83 procentpoint større end placebo hos dem, der fik et sulfonylurinstof.
English: Added to metformin and pioglitazone, canagliflozin was also superior to placebo, leading to HbA1c reductions that were 0.62 and 0.76 points more than was seen by adding placebo.
Danish: Også som tillægsbehandling til metformin og pioglitazon var canagliflozin bedre end placebo: Det gav en 0,62 og 0,76 procentpoint større nedsættelse af HbA1c end tillægsbehandling med placebo.
English: By blocking the action of SGLT2, canagliflozin causes more glucose to be removed via the urine,
Danish: Ved at blokere SGLT2 øger canagliflozin sukkerudskillelsen i urinen, så sukkerindholdet i blodet mindskes.
English: The studies, involving over 5,000 adults with type 2 diabetes, studied canagliflozin at daily doses of 100 and 300 mg and looked mainly at how they reduced the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Danish: Over 5 000 voksne med type 2-diabetes deltog i undersøgelserne, hvor canagliflozin blev brugt i en dosis på 100 og 300 mg dagligt.
English: This leads to high levels of glucose in the blood.
Danish: Derfor bliver blodsukkeret for højt.
English: In two studies evaluating canagliflozin as an add-on to metformin, the reductions in HbA1c levels after 26 weeks was 0.91 to 1.16 percentage points higher with canagliflozin than with placebo (a dummy treatment) when added to metformin and canagliflozin achieved similar reductions to two other diabetes medicines, glimepiride and sitagliptin, after 52 weeks of treatment.
Danish: I to undersøgelser, hvor canagliflozin blev brugt som tillægsbehandling til metformin, var HbA1c efter 26 uger nedsat 0,91-1,16 procentpoint mere med canagliflozin end med placebo (en virkningsløs behandling).
English: MA (EU) number (Invented) name
Danish: MF (EU)-nummer (Særnav n) Navn
English: EMA/324406/2015 Corr.1
Danish: EMA/324406/2015
English: Bleeding such as bleeding in the eye, nose, brain or gut has also been reported.
Danish: Der er også blevet indberettet tilfælde af blødning som f.eks. blødning i øjne, næse, hjerne eller mave-tarm system.
English: This means that there are bibliographic data providing scientific evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.
Danish: Det betyder, at der foreligger bibliografiske data der danner videnskabelig dokumentation for lægemidlernes sikkerhed og virkning, når de anvendes på denne måde, omfattende en periode på mindst 10 år i EU.
English: For the treatment of minor circulation problems, a doctor or a qualified healthcare practitioner should be consulted if symptoms persist for longer than 2 weeks.
Danish: Ved behandling af lette kredsløbsproblemer bør du kontakte en læge eller kvalificeret sundhedsmedarbejder, hvis symptomerne varer ved i mere end 2 uger.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Danish: Det betyder, at selvom der ikke foreligger tilstrækkelig dokumentation fra kliniske undersøgelser, kan det antages, at disse plantelægemidler har en virkning, og der er dokumentation for, at de har været anvendt sikkert på denne måde i mindst 30 år (herunder mindst 15 år inden for EU).
English: The exact way ginkgo leaf works in dementia is not fully understood but it is thought to protect brain cells from damage either directly or indirectly by regulating blood flow or by neutralising toxic forms of oxygen molecules (called oxygen free radicals).
Danish: Den præcise virkningsmekanisme bag demens kendes ikke, men menes at beskytte hjernecellerne mod skader enten ved direkte eller indirekte at regulere blodtilstrømningen, eller ved at neutralisere skadelige iltforbindelser (de såkaldte frie radikaler).
English: Ginkgo leaf medicines should only be used in adults.
Danish: Lægemidler med ginkgoblad bør kun anvendes til voksne.
English: Any applications for the licensing of medicines containing ginkgo leaf have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder ginkgoblad, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: In its assessment, the HMPC considered a number of clinical studies with ginkgo leaf looking at its effectiveness in improving memory.
Danish: I sin vurdering tog HMPC højde for en række kliniske undersøgelser med ginkgoblad, hvor der blev set nærmere på forbedring af hukommelsen.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing ginkgo leaf.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder ginkgoblad.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of ginkgo leaf.
Danish: Dette er et sammendrag af Komiteen Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af ginkgoblad.
English: Ginkgo leaf
Danish: Ginkgoblad
English: The dry extract is prepared using a technique to extract compounds from plant material by dissolving them in acetone which is then evaporated to obtain the dry extract.
Danish: Det tørre ekstrakt fremstilles ved at lave et udtræk med acetone, som derefter fordampes for at få det tørre ekstrakt.
English: These ginkgo leaf preparations can also be found in combination with other herbal substances in some herbal medicines.
Danish: Ginkgoblad findes desuden kombineret med andre droger i visse plantelægemidler.