FrancophonIA/ELRC3.0 huggingface dataset:
English: • Segluromet 7.5 mg/850 mg film-coated tablets (tablets) are dark brown, 18 x 10 mm oval, film-coated tablets debossed with “7.5/850” on one side and plain on the other side.
Danish: • Segluromet 7,5 mg/850 mg filmovertrukne tabletter (tabletter) er mørkebrune, 18 x 10 mm, ovale, filmovertrukne tabletter præget med “7.5/850” på den ene side og uden prægning på den anden side.
English: Segluromet 2.5 mg/850 mg film-coated tablets Segluromet 2.5 mg/1,000 mg film-coated tablets Segluromet 7.5 mg/850 mg film-coated tablets Segluromet 7.5 mg/1,000 mg film-coated tablets
Danish: Segluromet 2,5 mg/850 mg filmovertrukne tabletter Segluromet 2,5 mg/1.000 mg filmovertrukne tabletter Segluromet 7,5 mg/850 mg filmovertrukne tabletter Segluromet 7,5 mg/1.000 mg filmovertrukne tabletter
English: • Segluromet 7.5 mg/1,000 mg film-coated tablets (tablets) are red, 19.1 x 10.6 mm oval, film-coated tablets debossed with “7.5/1000” on one side and plain on the other side.
Danish: • Segluromet 7,5 mg/1.000 mg filmovertrukne tabletter (tabletter) er røde, 19,1 x 10,6 mm, ovale, filmovertrukne tabletter præget med “7.5/1000” på den ene side og uden prægning på den anden side.
English: • Segluromet 2.5 mg/1,000 mg film-coated tablets (tablets) are pink, 19.1 x 10.6 mm oval, film-coated tablets debossed with “2.5/1000” on one side and plain on the other side.
Danish: • Segluromet 2,5 mg/1.000 mg filmovertrukne tabletter (tabletter) er lyserøde, 19,1 x 10,6 mm, ovale, filmovertrukne tabletter præget med “2.5/1000” på den ene side og uden prægning på den anden side.
English: Difference from Sitagliptin (LS mean
Danish: Forskel fra sitagliptin
English: In the study of patients inadequately controlled on metformin with baseline HbA1c from 7.5-11.0%, among the subgroup of patients with a baseline HbA1c ≥ 10%, the combination of ertugliflozin 5 mg or 15 mg with sitagliptin resulted in reductions of HbA1c of 2.35% and 2.66%, respectively, compared to 2.10%, 1.30%, and 1.82% for ertugliflozin 5 mg, ertugliflozin 15 mg, and sitagliptin alone, respectively.
Danish: 5 mg eller 15 mg med sitagliptin fald i HbA1c på henholdsvis 2,35% og 2,66% sammenlignet med 2,10%; 1,30% og 1,82% for henholdsvis ertugliflozin 5 mg, ertugliflozin 15 mg og sitagliptin alene.
English: - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1; - any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis [DKA]); - diabetic pre coma;
Danish: - enhver type af akut metabolisk acidose (såsom laktacidose, diabetisk ketoacidose.
English: BLISTER FOR SEGLUROMET 2.5 mg/1000 mg
Danish: BLISTER TIL SEGLUROMET 2,5 mg/1.000 mg
English: BLISTER FOR SEGLUROMET 7.5 mg/1000 mg
Danish: BLISTER TIL SEGLUROMET 7,5 mg/1.000 mg
English: BLISTER FOR SEGLUROMET 2.5 mg/850 mg
Danish: BLISTER TIL SEGLUROMET 2,5 mg/850 mg
English: What you need to know before you take Segluromet 3.
Danish: Det skal du vide, før du begynder at tage Segluromet Sådan skal du tage Segluromet Bivirkninger
English: BLISTER FOR SEGLUROMET 7.5 mg/850 mg
Danish: BLISTER TIL SEGLUROMET 7,5 mg/850 mg
English: In patients where DKA is suspected or diagnosed, treatment with Segluromet should be discontinued immediately.
Danish: Behandlingen med Segluromet skal straks seponeres hos patienter med formodet eller diagnosticeret diabetisk ketoacidose.
English: OUTER CARTON FOR SEGLUROMET 7.5 mg/1000 mg
Danish: YDRE KARTON TIL SEGLUROMET 7,5 mg/1.000 mg
English: OUTER CARTON FOR SEGLUROMET 2.5 mg/1000 mg
Danish: YDRE KARTON TIL SEGLUROMET 2,5 mg/1.000 mg
English: Urine glucose
Danish: Sukker i urinen
English: Segluromet 7.5 mg/1,000 mg film-coated tablets EU/1/18/1265/022
Danish: Segluromet 7,5 mg/1.000 mg filmovertrukne tabletter EU/1/18/1265/022
English: Segluromet 2.5 mg/850 mg film-coated tablets EU/1/18/1265/001
Danish: Segluromet 2,5 mg/850 mg filmovertrukne tabletter EU/1/18/1265/001
English: INTERMEDIATE CARTON WITHOUT BLUE BOX - MULTIPACKS - SEGLUROMET 7.5 mg/850 mg
Danish: INDRE KARTON UDEN BLUE BOX - MULTIPAKNINGER - SEGLUROMET 7,5 mg/850 mg
English: OUTER CARTON FOR SEGLUROMET 7.5 mg/850 mg
Danish: YDRE KARTON TIL SEGLUROMET 7,5 mg/850 mg
English: INTERMEDIATE CARTON WITHOUT BLUE BOX - MULTIPACKS - SEGLUROMET 2.5 mg/850 mg
Danish: INDRE KARTON UDEN BLUE BOX - MULTIPAKNINGER - SEGLUROMET 2,5 mg/850 mg
English: INTERMEDIATE CARTON WITHOUT BLUE BOX - MULTIPACKS - SEGLUROMET 7.5 mg/1000 mg
Danish: INDRE KARTON UDEN BLUE BOX - MULTIPAKNINGER - SEGLUROMET 7,5 mg/1.000 mg
English: OUTER CARTON FOR SEGLUROMET 2.5 mg/850 mg
Danish: YDRE KARTON TIL SEGLUROMET 2,5 mg/850 mg
English: Segluromet 2.5 mg/1,000 mg film-coated tablets EU/1/18/1265/008
Danish: Segluromet 2,5 mg/1.000 mg filmovertrukne tabletter EU/1/18/1265/008
English: Segluromet 7.5 mg/850 mg film-coated tablets EU/1/18/1265/015
Danish: Segluromet 7,5 mg/850 mg filmovertrukne tabletter EU/1/18/1265/015
English: INTERMEDIATE CARTON WITHOUT BLUE BOX - MULTIPACKS - SEGLUROMET 2.5 mg/1000 mg
Danish: INDRE KARTON UDEN BLUE BOX - MULTIPAKNINGER - SEGLUROMET 2,5 mg/1.000 mg
English: Each tablet contains 7.5 mg of ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1000 mg of metformin hydrochloride.
Danish: Hver tablet indeholder 7,5 mg ertugliflozin (som ertugliflozin L-pyroglutaminsyre) og 1.000 mg metforminhydrochlorid.
English: Therefore, symptomatic hypotension may occur after initiating Segluromet (see section 4.8), particularly in patients with impaired renal function (eGFR less than 60 ml/min/1.73 m or a CrCl less than 60 ml/min), elderly patients (≥ 65 years), patients on diuretics, or patients on anti-hypertensive therapy with a history of hypotension.
Danish: 4.8), især hos patienter med nedsat nyrefunktion (eGFR under 60 ml/min/1,73 m2 eller CrCl under
English: o Each Segluromet 2.5 mg/850 mg film-coated tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 850 mg of metformin hydrochloride.
Danish: o Hver Segluromet 2,5 mg/850 mg filmovertrukken tablet indeholder 2,5 mg ertugliflozin (som ertugliflozin L-pyroglutaminsyre) og 850 mg metforminhydrochlorid.
English: Segluromet 2.5 mg/1,000 mg film-coated tablets and Segluromet 7.5 mg/1,000 mg film-coated tablets Hypromellose (E464)
Danish: Segluromet 2,5 mg/1.000 mg filmovertrukne tabletter og Segluromet 7,5 mg/1.000 mg filmovertrukne tabletter
English: o Each Segluromet 7.5 mg/850 mg film-coated tablet contains 7.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 850 mg of metformin hydrochloride.
Danish: o Hver Segluromet 7,5 mg/850 mg filmovertrukken tablet indeholder 7,5 mg ertugliflozin (som ertugliflozin L-pyroglutaminsyre) og 850 mg metforminhydrochlorid.
English: Segluromet 2.5 mg/1,000 mg film-coated tablets Each tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg of metformin hydrochloride.
Danish: Segluromet 2,5 mg/1.000 mg filmovertrukne tabletter Hver tablet indeholder 2,5 mg ertugliflozin (som ertugliflozin L-pyroglutaminsyre) og 1.000 mg metforminhydrochlorid.
English: Each tablet contains 2.5 mg of ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1000 mg of metformin hydrochloride.
Danish: Hver tablet indeholder 2,5 mg ertugliflozin (som ertugliflozin L-pyroglutaminsyre) og 1.000 mg metforminhydrochlorid.
English: Segluromet 7.5 mg/1,000 mg film-coated tablets Each tablet contains 7.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg metformin hydrochloride.
Danish: Segluromet 7,5 mg/1.000 mg filmovertrukne tabletter Hver tablet indeholder 7,5 mg ertugliflozin (som ertugliflozin L-pyroglutaminsyre) og 1.000 mg metforminhydrochlorid.
English: Segluromet 2.5 mg/850 mg film-coated tablets and Segluromet 7.5 mg/850 mg film-coated tablets Hypromellose (E464)
Danish: Segluromet 2,5 mg/850 mg filmovertrukne tabletter og Segluromet 7,5 mg/850 mg filmovertrukne tabletter
English: Change from baseline (LS mean Difference from glimepiride (LS mean
Danish: Baseline (gennemsnit) Ændring fra baseline Forskel fra placebo
English: Segluromet 7.5 mg/1000 mg tablets ertugliflozin/metformin hydrochloride
Danish: Segluromet 7,5 mg/1.000 mg tabletter ertugliflozin/metforminhydrochlorid
English: Segluromet 7.5 mg/850 mg tablets ertugliflozin/metformin hydrochloride
Danish: Segluromet 7,5 mg/850 mg tabletter ertugliflozin/metforminhydrochlorid
English: Segluromet 2.5 mg/850 mg tablets ertugliflozin/metformin hydrochloride
Danish: Segluromet 2,5 mg/850 mg tabletter ertugliflozin/metforminhydrochlorid
English: Each tablet contains 7.5 mg of ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 850 mg of metformin hydrochloride.
Danish: Hver tablet indeholder 7,5 mg ertugliflozin (som ertugliflozin L-pyroglutaminsyre) og 850 mg metforminhydrochlorid.
English: • painful urination
Danish: • smerter ved vandladning
English: o Each Segluromet 7.5 mg/1,000 mg film-coated tablet contains 7.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg of metformin hydrochloride.
Danish: o Hver Segluromet 7,5 mg/1.000 mg filmovertrukken tablet indeholder 7,5 mg ertugliflozin (som ertugliflozin L-pyroglutaminsyre) og 1.000 mg metforminhydrochlorid.
English: Segluromet 2.5 mg/1000 mg tablets ertugliflozin/metformin hydrochloride
Danish: Segluromet 2,5 mg/1.000 mg tabletter ertugliflozin/metforminhydrochlorid
English: Each tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 850 mg of metformin hydrochloride.
Danish: Hver tablet indeholder 2,5 mg ertugliflozin (som ertugliflozin L-pyroglutaminsyre) og 850 mg metforminhydrochlorid.
English: o Each Segluromet 2.5 mg/1,000 mg film-coated tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg of metformin hydrochloride.
Danish: o Hver Segluromet 2,5 mg/1.000 mg filmovertrukken tablet indeholder 2,5 mg ertugliflozin (som ertugliflozin L-pyroglutaminsyre) og 1.000 mg metforminhydrochlorid.
English: Segluromet 7.5 mg/1000 mg film-coated tablets ertugliflozin/metformin hydrochloride
Danish: Segluromet 7,5 mg/1.000 mg filmovertrukne tabletter ertugliflozin/metforminhydrochlorid
English: Segluromet 2.5 mg/850 mg film-coated tablets ertugliflozin/metformin hydrochloride
Danish: Segluromet 2,5 mg/850 mg filmovertrukne tabletter ertugliflozin/metforminhydrochlorid
English: Segluromet 2.5 mg/1000 mg film-coated tablets ertugliflozin/metformin hydrochloride
Danish: Segluromet 2,5 mg/1.000 mg filmovertrukne tabletter ertugliflozin/metforminhydrochlorid
English: Segluromet 7.5 mg/850 mg film-coated tablets ertugliflozin/metformin hydrochloride
Danish: Segluromet 7,5 mg/850 mg filmovertrukne tabletter ertugliflozin/metforminhydrochlorid
English: EU/1/18/1265/022 (14 film-coated tablets) EU/1/18/1265/023 (28 film-coated tablets) EU/1/18/1265/024 (30x1 film-coated tablets) EU/1/18/1265/025 (56 film-coated tablets) EU/1/18/1265/026 (60 film-coated tablets) EU/1/18/1265/027 (168 film-coated tablets) EU/1/18/1265/028 (180 film-coated tablets) EU/1/18/1265/032 (196 (4 x 49) film-coated tablets)
Danish: EU/1/18/1265/022 (14 filmovertrukne tabletter) EU/1/18/1265/023 (28 filmovertrukne tabletter) EU/1/18/1265/024 (30x1 filmovertrukne tabletter) EU/1/18/1265/025 (56 filmovertrukne tabletter) EU/1/18/1265/026 (60 filmovertrukne tabletter) EU/1/18/1265/027 (168 filmovertrukne tabletter) EU/1/18/1265/028 (180 filmovertrukne tabletter) EU/1/18/1265/032 (196 (4 x 49) filmovertrukne tabletter)
English: EU/1/18/1265/008 (14 film-coated tablets) EU/1/18/1265/009 (28 film-coated tablets) EU/1/18/1265/010 (30x1 film-coated tablets) EU/1/18/1265/011 (56 film-coated tablets) EU/1/18/1265/012 (60 film-coated tablets) EU/1/18/1265/013 (168 film-coated tablets) EU/1/18/1265/014 (180 film-coated tablets) EU/1/18/1265/030 (196 (4 x 49) film-coated tablets)
Danish: EU/1/18/1265/008 (14 filmovertrukne tabletter) EU/1/18/1265/009 (28 filmovertrukne tabletter) EU/1/18/1265/010 (30x1 filmovertrukne tabletter) EU/1/18/1265/011 (56 filmovertrukne tabletter) EU/1/18/1265/012 (60 filmovertrukne tabletter) EU/1/18/1265/013 (168 filmovertrukne tabletter) EU/1/18/1265/014 (180 filmovertrukne tabletter) EU/1/18/1265/030 (196 (4 x 49) filmovertrukne tabletter)
English: EU/1/18/1265/001 (14 film-coated tablets) EU/1/18/1265/002 (28 film-coated tablets) EU/1/18/1265/003 (30x1 film-coated tablets) EU/1/18/1265/004 (56 film-coated tablets) EU/1/18/1265/005 (60 film-coated tablets) EU/1/18/1265/006 (168 film-coated tablets) EU/1/18/1265/007 (180 film-coated tablets) EU/1/18/1265/029 (196 (4 x 49) film-coated tablets)
Danish: EU/1/18/1265/001 (14 filmovertrukne tabletter) EU/1/18/1265/002 (28 filmovertrukne tabletter) EU/1/18/1265/003 (30x1 filmovertrukne tabletter) EU/1/18/1265/004 (56 filmovertrukne tabletter) EU/1/18/1265/005 (60 filmovertrukne tabletter) EU/1/18/1265/006 (168 filmovertrukne tabletter) EU/1/18/1265/007 (180 filmovertrukne tabletter) EU/1/18/1265/029 (196 (4 x 49) filmovertrukne tabletter)
English: EU/1/18/1265/015 (14 film-coated tablets) EU/1/18/1265/016 (28 film-coated tablets) EU/1/18/1265/017 (30x1 film-coated tablets) EU/1/18/1265/018 (56 film-coated tablets) EU/1/18/1265/019 (60 film-coated tablets) EU/1/18/1265/020 (168 film-coated tablets) EU/1/18/1265/021 (180 film-coated tablets) EU/1/18/1265/031 (196 (4 x 49) film-coated tablets)
Danish: EU/1/18/1265/015 (14 filmovertrukne tabletter) EU/1/18/1265/016 (28 filmovertrukne tabletter) EU/1/18/1265/017 (30x1 filmovertrukne tabletter) EU/1/18/1265/018 (56 filmovertrukne tabletter) EU/1/18/1265/019 (60 filmovertrukne tabletter) EU/1/18/1265/020 (168 filmovertrukne tabletter) EU/1/18/1265/021 (180 filmovertrukne tabletter) EU/1/18/1265/031 (196 (4 x 49) filmovertrukne tabletter)
English: • feeling sick or being sick
Danish: • kvalme eller opkastning
English: Fasting plasma glucose
Danish: Forskel fra glimepirid
English: • vaginal yeast infection (thrush)
Danish: • svampeinfektion i skeden (trøske)
English: • dizziness
Danish: • kløe
English: • fainting
Danish: • svedtendens
English: Dark brown, 18 x 10 mm oval, film-coated tablet debossed with “7.5/850” on one side and plain on the other side.
Danish: Segluromet 7,5 mg/850 mg filmovertrukne tabletter Mørkebrune, 18 x 10 mm, ovale, filmovertrukne tabletter præget med “7.5/850” på den ene side og uden prægning på den anden side.
English: Red, 19.1 x 10.6 mm oval, film-coated tablet debossed with “7.5/1000” on one side and plain on the other side.
Danish: Segluromet 7,5 mg/1.000 mg filmovertrukne tabletter Røde, 19,1 x 10,6 mm, ovale, filmovertrukne tabletter præget med “7.5/1000” på den ene side og uden prægning på den anden side.
English: Beige, 18 x 10 mm oval, film-coated tablet debossed with “2.5/850” on one side and plain on the other side.
Danish: Segluromet 2,5 mg/850 mg filmovertrukne tabletter Beige, 18 x 10 mm, ovale, filmovertrukne tabletter præget med “2.5/850” på den ene side og uden prægning på den anden side.
English: Liver function test abnormal 2, Hepatitis
Danish: 2, hepatitis
English: Pink, 19.1 x 10.6 mm oval, film-coated tablet debossed with “2.5/1000” on one side and plain on the other side.
Danish: Segluromet 2,5 mg/1.000 mg filmovertrukne tabletter Lyserøde, 19,1 x 10,6 mm, ovale, filmovertrukne tabletter præget med “2.5/1000” på den ene side og uden prægning på den anden side.
English: Iron oxide yellow (E172)
Danish: Gul jernoxid E172
English: For the full list of excipients, see section 6.1.
Danish: Segluromet (angivet i punkt 6).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Epivir on 8 August 1996.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Epivir den 8. august 1996.
English: This can be taken either as a single daily dose or divided into 150 mg twice a day.
Danish: Det kan enten tages som en enkelt daglig dosis eller opdelt i 150 mg to gange dagligt.
English: This document is a summary of the European Public Assessment Report (EPAR) for Epivir.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Epivir.
English: It is available as tablets (150 and 300 mg) and as an oral solution (10 mg/ml).
Danish: Det leveres som tabletter (150 og 300 mg) og som en oral opløsning (10 mg/ml).
English: The study measured how long the patients lived without their disease getting worse.
Danish: I undersøgelsen måltes det, hvor lang tid patienterne levede uden en forværring af deres sygdom.
English: The oral solution can be used to achieve the appropriate dose.
Danish: Den orale opløsning kan anvendes til at opnå en passende dosis.
English: Similar results were seen in HIV-infected patients aged under 15 years.
Danish: Tilsvarende resultater blev set hos hiv-smittede patienter under 15 år.
English: Epivir lamivudine
Danish: Epivir lamivudin
English: A risk management plan has been developed to ensure that Epivir is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Epivir anvendes så sikkert som muligt.
English: The full EPAR for Epivir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Epivir findes ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The combination also reduced viral loads in all studies after two to four weeks of treatment, but this effect was temporary.
Danish: Kombinationen reducerede endvidere virusmængden i blodet i alle undersøgelserne efter to til fire ugers behandling, men denne virkning var forbigående.
English: It does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Danish: Det helbreder ikke HIV-infektion eller AIDS, men det kan forhale den beskadigelse af immunsystemet og hindre udvikling af infektioner og sygdomme, som er forbundet med AIDS.
English: Epivir has also been studied in 615 patients aged between nine months and 15 years.
Danish: Epivir er også blevet undersøgt hos 615 patienter i alderen fra ni måneder til 15 år.
English: Treatment with Epivir should be started by a doctor who has experience in the management of HIV infection.
Danish: Behandlingen med Epivir bør igangsættes af en læge, der har erfaring i behandling af HIV-infektion.
English: Patients who cannot swallow tablets should use the oral solution, or alternatively they may crush the tablets and add them to a small amount of food or drink immediately before swallowing it.
Danish: Patienter, der ikke kan sluge tabletter, bør anvende den orale opløsning, eller alternativt knuse tabletterne og komme dem i lidt mad eller drikke, umiddelbart inden de synker det.
English: Epivir is a medicine containing the active substance lamivudine.
Danish: Epivir er et lægemiddel, der indeholder det aktive stof lamivudin.
English: This study looked at how many patients had developed an illness associated with AIDS or had died after a year's treatment.
Danish: I denne undersøgelse så man nærmere på, hvor mange patienter der udviklede en sygdom forbundet med AIDS, eller som døde efter et års behandling.
English: Other information about Epivir
Danish: Andre oplysninger om Epivir
English: Epivir has been studied in five main studies involving almost 3,000 adults (aged 18 years or over).
Danish: Epivir blev undersøgt i fem hovedundersøgelser, der omfattede næsten 3 000 voksne (på 18 år eller derover).
English: In children weighing less than 25 kg the recommended dose depends on their weight.
Danish: Hos børn på under 25 kg afhænger den anbefalede dosis af legemsvægten.
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 Epivir.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Epivir.
English: The recommended dose of Epivir for adults and children weighing at least 25 kg is 300 mg a day.
Danish: Den anbefalede dosis af Epivir til voksne og børn over 25 kg er 300 mg dagligt.
English: The CHMP decided that Epivir's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Epivir er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Epivir.
English: CD4 T-cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Danish: CD4 T-celler er hvide blodlegemer, som er vigtige for, at kroppen kan bekæmpe infektioner, men som dræbes af HIV.
English: What measures are being taken to ensure the safe and effective use of Epivir?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Epivir?
English: Epivir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Når Epivir tages i kombination med andre antiretrovirale lægemidler, reducerer det mængden af HIV i blodet og holder det på et lavt niveau.
English: For more information about treatment with Epivir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Epivir, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In the fifth adult study, adding Epivir to existing treatment reduced the risk of disease progression or death: after a year, 9% of the patients taking Epivir had developed an AIDS-related illness or died (128 out of 1,369), compared with 20% of those taking placebo (95 out of 471).
Danish: I den femte undersøgelse af voksne, hvor Epivir blev føjet til en eksisterende behandling, blev risikoen for sygdomsprogression eller død reduceret: Efter et år var 9 % af de patienter, der tog Epivir, døde eller havde udviklet en AIDS-relateret sygdom (128 af 1 369), mod 20 % af de patienter, der havde taget placebo (95 af 471).
English: The studies examined the effects of Epivir on the levels of HIV in the blood (viral load) and the number of CD4 T-cells in the blood (CD4 cell count).
Danish: I undersøgelserne så man nærmere på Epivirs virkning på niveauerne af HIV i blodet (virusindhold) og på antallet af CD4 T-celler i blodet (CD4-celletallet).
English: The most common side effects with Epivir (seen in between 1 and 10 patients in 100) are diarrhoea, nausea (feeling sick), vomiting, headache, insomnia (difficulty sleeping), cough, nasal symptoms, rash, muscle disorders, arthralgia (joint pain), alopecia (hair loss), fever, abdominal pain (stomach ache) or cramps, malaise (feeling unwell) and fatigue (tiredness).
Danish: De mest almindelige bivirkninger ved Epivir (set hos mellem 1 og 10 ud af 100 patienter) er diarré, kvalme, opkastning, hovedpine, søvnløshed (søvnbesvær), hoste, næsesymptomer, udslæt, muskelgener, ledsmerter, alopeci (hårtab), feber, mavesmerter eller -kramper, utilpashed og træthed.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Epivir, 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 Epivir, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The fifth study compared the effects of adding Epivir or placebo (a dummy treatment) to existing treatment for HIV infection in 1,895 adults who had been taking antiviral medicines for at least four weeks.
Danish: I den femte undersøgelse sammenlignedes virkningen af at tilføje Epivir eller placebo (en uvirksom behandling) til eksisterende behandling af HIV-infektion hos 1 895 voksne, som havde taget antiretrovirale lægemidler i mindst fire uger.