FrancophonIA/ELRC3.0 huggingface dataset:
English: Dafiro 5 mg/80 mg film-coated tablets Dafiro 5 mg/160 mg film-coated tablets Dafiro 10 mg/160 mg film-coated tablets
Danish: Dafiro 5 mg/80 mg filmovertrukne tabletter Dafiro 5 mg/160 mg filmovertrukne tabletter Dafiro 10 mg/160 mg filmovertrukne tabletter
English: Very rare (may affect up to 1 in 10,000 people): Decreased number of white blood cells, decrease in blood platelets which may result in unusual brusing or easy bleeding (red blood cell damage); excess sugar in blood (hyperglycaemia); swelling of the gums, abdominal bloating (gastritis); abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests; increased muscle tension; inflammation of blood vessels often with skin rash, sensitivity to light; disorders combining rigidity, tremor and/or movement disorders.
Danish: Meget sjælden (kan forekomme hos op til 1 ud af 10.000 personer): Nedsat antal hvide blodlegemer, nedsat antal blodplader, som kan medføre blå mærker og tendens til blødning; forhøjet blodsukker; hævede gummer, mavekatar; påvirket leverfunktion, leverbetændelse, gul hud, forhøjede leverenzymer (ses ved blodprøver); øget muskelspænding; årebetændelse, oftest med hududslæt; øget lysfølsomhed; en tilstand med stivhed, rysten og/eller bevægelsesforstyrrelser.
English: Dafiro can be used with or without food.
Danish: Dafiro kan tages uden hensyn til fødeindtagelse.
English: Dermatitis bullous
Danish: Bulløs dermatit
English: Uncommon (may affect up to 1 in 100 people): 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.
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer): Svimmelhed; kvalme og mavesmerter; mundtørhed; sløvhed; prikken og følelsesløshed i hænder eller fødder; svimmelhed; hurtigt hjerteslag inklusive hjertebanken; svimmelhed ved skift til stående stilling; hoste; diarré; forstoppelse; hududslæt; rødme af huden; hævelse af led, rygsmerter; ledsmerter.
English: Change of bowel habit
Danish: Ændring i afføringsvaner
English: Uncommon (may affect up to 1 in 100 people): Mood changes, anxiety, depression, sleeplessness, trembling, taste abnormalities, fainting, loss of pain sensation; visual disturbances, visual impairment, ringing in the ears; low blood pressure; sneezing/runny nose caused by inflammation of the lining of the nose (rhinitis); indigestion, vomiting (being sick); hair loss, increased sweating, itchy skin, skin discolouration; disorder in passing urine, increased need to urinate at night, increased number of times of passing urine; inability to obtain an erection, discomfort or enlargement of the breasts in men, pain, feeling unwell, muscle pain, muscle cramps; weight increase or decrease.
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer): Humørsvingninger, angst, depression, søvnløshed, rysten, smagsforstyrrelser, besvimelse, manglende smertefølelse; synsforstyrrelser, nedsat syn, tinnitus; lavt blodtryk; nysen/snue pga. en betændelseslignende reaktion i næseslimhinden; fordøjelsesbesvær, opkastning; hårtab, øget svedtendens, hudkløe, misfarvninger af huden; vandladningsforstyrrelser, hyppigere vandladning, også om natten; erektionsproblemer, udvikling af bryster hos mænd, smerter, utilpashed, muskelsmerter, muskelkramper; vægtændring.
English: Dark yellow, oval film-coated tablet, imprinted with “NVR” on one side and “ECE” on the other side.
Danish: Mørkegul, oval filmovertrukket tablet, præget med ”NVR” på den ene side og ”ECE” på den anden side.
English: Uncommon Very rare Uncommon
Danish: Almindelig Almindelig Ikke almindelig
English: Light yellow, oval film-coated tablet, imprinted with “NVR” on one side and “UIC” on the other side.
Danish: Lysegul, oval filmovertrukket tablet, præget med ”NVR” på den ene side og ”UIC” på den anden side.
English: What Dafiro is and what it is used for What you need to know before you take Dafiro How to take Dafiro
Danish: Det skal du vide, før du begynder at tage Dafiro Sådan skal du tage Dafiro Bivirkninger
English: Dafiro 5 mg/80 mg film-coated tablets
Danish: Dafiro 5 mg/80 mg filmovertrukne tabletter
English: Dark yellow, round film-coated tablet with bevelled edges, imprinted with “NVR” on one side and “NV” on the other side.
Danish: Mørkegul, rund filmovertrukket tablet med facetslebne kanter, præget med ”NVR” på den ene side og ”NV” på den anden side.
English: Uncommon Not known
Danish: Valsartan Ikke kendt
English: Visual disturbance
Danish: Synsforstyrrelser
English: Your doctor may also check your kidney function; anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone); St. John's wort; nitroglycerin and other nitrates, or other substances called “vasodilators”; medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir); medicines used to treat fungal infections (e.g. ketoconazole, itraconazole); medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, talithromycin); verapamil, diltiazem (heart medicines); simvastatin (a medicine used to control high cholesterol levels); dantrolene (infusion for severe body temperature abnormalities); medicines used to protect against transplant rejection (ciclosporin).
Danish: primidon); - perikon; - glyceryltrinitrat (nitroglycerin) og andre nitrater eller andre stoffer, som kaldes ”vasodilatorer”; - medicin mod hiv/aids (f.eks. ritonavir, indinavir, nelfinavir); - medicin til behandling af svampeinfektioner (f.eks. ketoconazol, itraconazol); - medicin til behandling af bakterieinfektioner (f.eks. rifampicin, erythromycin, clarithromycin,
English: EU/1/06/371/034 280 film-coated tablets (4x70) EU/1/06/371/037 280 film-coated tablets (20x14)
Danish: EU/1/06/371/034 280 filmovertrukne tabletter (4x70) EU/1/06/371/037 280 filmovertrukne tabletter (20x14)
English: Dafiro 10 mg/160 mg film-coated tablets
Danish: Dafiro 10 mg/160 mg filmovertrukne tabletter
English: Weight decrease
Danish: Nedsat leverfunktion
English: Dafiro 5 mg/80 mg film-coated tablets Dafiro 5 mg/160 mg film-coated tablets Dafiro 10 mg/160 mg film-coated tablets amlodipine/valsartan
Danish: Dafiro 5 mg/80 mg filmovertrukne tabletter Dafiro 5 mg/160 mg filmovertrukne tabletter Dafiro 10 mg/160 mg filmovertrukne tabletter amlodipin/valsartan
English: EU/1/06/371/035 280 film-coated tablets (4x70) EU/1/06/371/038 280 film-coated tablets (20x14)
Danish: EU/1/06/371/035 280 filmovertrukne tabletter (4x70) EU/1/06/371/038 280 filmovertrukne tabletter (20x14)
English: Photosensitivity reaction
Danish: Lysfølsomhed
English: EU/1/06/371/036 280 film-coated tablets (4x70) EU/1/06/371/039 280 film-coated tablets (20x14)
Danish: EU/1/06/371/036 280 filmovertrukne tabletter (4x70) EU/1/06/371/039 280 filmovertrukne tabletter (20x14)
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen.
English: Dafiro 10 mg/160 mg film-coated tablets amlodipine/valsartan
Danish: Dafiro 10 mg/160 mg filmovertrukne tabletter amlodipin/valsartan
English: A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure <90 mmHg at the end of the trial) in patients not adequately controlled on amlodipine 10 mg in 78% of patients treated with amlodipine/valsartan 10 mg/160 mg, compared to 67% of patients remaining on amlodipine 10 mg.
Danish: Et multicenter, randomiseret, dobbeltblindet, aktivt kontrolleret, parallelgruppestudie undersøgte patienter, der ikke var tilstrækkeligt kontrolleret med amlodipin 10 mg, med henblik på en normalisering af blodtrykket (defineret som middel siddende diastolisk blodtryk <90 mmHg ved slutningen af studiet).
English: Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Danish: Det anbefales at udføre ultralydsscanning for at tjekke nyrefunktionen og kraniet, hvis fosteret har været udsat for AIIA fra andet trimester.
English: Each tablet contains 5 mg amlodipine and 80 mg valsartan.
Danish: Hver tablet indeholder 5 mg amlodipin og 80 mg valsartan.
English: Active-controlled trials in patients who were non-responders to monotherapy A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure <90 mmHg at the end of the trial) in patients not adequately controlled on valsartan 160 mg in 75% of patients treated with amlodipine/valsartan 10 mg/160 mg and 62% of patients treated with amlodipine/valsartan 5 mg/160 mg, compared to 53% of patients remaining on valsartan 160 mg.
Danish: Aktivt kontrollerede studier med patienter, som ikke responderer på monoterapi Et multicenter, randomiseret, dobbeltblindet, aktivt kontrolleret, parallelgruppestudie undersøgte patienter, der ikke var tilstrækkeligt kontrolleret med valsartan 160 mg, med henblik på en normalisering af blodtrykket (defineret som middel siddende diastolisk blodtryk <90 mmHg ved slutningen af studiet).
English: Common (may affect up to 1 in 10 people): Dizziness, sleepiness; palpitations (awareness of your heart beat); flushing, ankle swelling (oedema); abdominal pain, feeling sick (nausea).
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer): Svimmelhed, døsighed; hjertebanken; ansigtsrødme, hævede ankler (ødemer); mavesmerter, kvalme.
English: Dafiro 5 mg/160 mg film-coated tablets
Danish: Dafiro 5 mg/160 mg filmovertrukne tabletter
English: What Dafiro looks like and contents of the pack Dafiro 5 mg/80 mg tablets are round and dark yellow with “NVR” on one side and “NV” on the other side.
Danish: Dafiro 5 mg/80 mg tabletter er runde og mørkegule, præget med ”NVR” på den ene side og ”NV” på den anden side.
English: if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).
Danish: (en tilstand, hvor hjertet ikke er i stand til at opretholde tilstrækkelig blodforsyning til kroppen).
English: Coordination abnormal
Danish: Koordinationsbesvær
English: Apontis Pharma GmbH & Co. KG Tel: +49 2173 48 4949
Danish: KG Tel: +49 2173 48 4949
English: No information is available regarding the use of Dafiro during breast-feeding, therefore Dafiro is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Danish: I stedet foretrækkes alternative behandlinger med bedre dokumenterede sikkerhedsprofiler ved amning, især ved amning af et nyfødt spædbarn eller et for tidligt født spædbarn.
English: Dafiro 5 mg/80 mg film-coated tablets amlodipine/valsartan
Danish: Dafiro 5 mg/80 mg filmovertrukne tabletter amlodipin/valsartan
English: Headache
Danish: Smerte
English: Renal failure and impairment
Danish: Nyresvigt og nedsat nyrefunktion
English: Each tablet contains 5 mg amlodipine and 160 mg valsartan.
Danish: Hver tablet indeholder 5 mg amlodipin og 160 mg valsartan.
English: Dafiro 5 mg/160 mg film-coated tablets amlodipine/valsartan
Danish: Dafiro 5 mg/160 mg filmovertrukne tabletter amlodipin/valsartan
English: Pharyngolaryngeal pain Uncommon Rhinitis
Danish: Faryngolaryngeale smerter
English: Blood potassium increased
Danish: Forhøjet kalium i blodet
English: EU/1/06/371/001 7 film-coated tablets EU/1/06/371/002 14 film-coated tablets EU/1/06/371/003 28 film-coated tablets EU/1/06/371/004 30 film-coated tablets EU/1/06/371/005 56 film-coated tablets EU/1/06/371/006 90 film-coated tablets EU/1/06/371/007 98 film-coated tablets EU/1/06/371/008 280 film-coated tablets EU/1/06/371/025 56x1 film-coated tablet (unit dose) EU/1/06/371/026 98x1 film-coated tablet (unit dose) EU/1/06/371/027 280x1 film-coated tablet (unit dose)
Danish: EU/1/06/371/001 7 filmovertrukne tabletter EU/1/06/371/002 14 filmovertrukne tabletter EU/1/06/371/003 28 filmovertrukne tabletter EU/1/06/371/004 30 filmovertrukne tabletter EU/1/06/371/005 56 filmovertrukne tabletter EU/1/06/371/006 90 filmovertrukne tabletter EU/1/06/371/007 98 filmovertrukne tabletter EU/1/06/371/008 280 filmovertrukne tabletter EU/1/06/371/025 56x1 filmovertrukket tablet (enhedsdosis) EU/1/06/371/026 98x1 filmovertrukket tablet (enhedsdosis) EU/1/06/371/027 280x1 filmovertrukket tablet (enhedsdosis)
English: Each tablet contains 10 mg amlodipine and 160 mg valsartan.
Danish: Hver tablet indeholder 10 mg amlodipin og 160 mg valsartan..
English: EU/1/06/371/017 7 film-coated tablets EU/1/06/371/018 14 film-coated tablets EU/1/06/371/019 28 film-coated tablets EU/1/06/371/020 30 film-coated tablets EU/1/06/371/021 56 film-coated tablets EU/1/06/371/022 90 film-coated tablets EU/1/06/371/023 98 film-coated tablets EU/1/06/371/024 280 film-coated tablets EU/1/06/371/031 56x1 film-coated tablet (unit dose) EU/1/06/371/032 98x1 film-coated tablet (unit dose) EU/1/06/371/033 280x1 film-coated tablet (unit dose)
Danish: EU/1/06/371/017 7 filmovertrukne tabletter EU/1/06/371/018 14 filmovertrukne tabletter EU/1/06/371/019 28 filmovertrukne tabletter EU/1/06/371/020 30 filmovertrukne tabletter EU/1/06/371/021 56 filmovertrukne tabletter EU/1/06/371/022 90 filmovertrukne tabletter EU/1/06/371/023 98 filmovertrukne tabletter EU/1/06/371/024 280 filmovertrukne tabletter EU/1/06/371/031 56x1 filmovertrukket tablet (enhedsdosis) EU/1/06/371/032 98x1 filmovertrukket tablet (enhedsdosis) EU/1/06/371/033 280x1 filmovertrukket tablet (enhedsdosis)
English: Common Uncommon
Danish: Almindelig Ikke almindelig
English: EU/1/06/371/009 7 film-coated tablets EU/1/06/371/010 14 film-coated tablets EU/1/06/371/011 28 film-coated tablets EU/1/06/371/012 30 film-coated tablets EU/1/06/371/013 56 film-coated tablets EU/1/06/371/014 90 film-coated tablets EU/1/06/371/015 98 film-coated tablets EU/1/06/371/016 280 film-coated tablets EU/1/06/371/028 56x1 film-coated tablet (unit dose) EU/1/06/371/029 98x1 film-coated tablet (unit dose) EU/1/06/371/030 280x1 film-coated tablet (unit dose)
Danish: EU/1/06/371/009 7 filmovertrukne tabletter EU/1/06/371/010 14 filmovertrukne tabletter EU/1/06/371/011 28 filmovertrukne tabletter EU/1/06/371/012 30 filmovertrukne tabletter EU/1/06/371/013 56 filmovertrukne tabletter EU/1/06/371/014 90 filmovertrukne tabletter EU/1/06/371/015 98 filmovertrukne tabletter EU/1/06/371/016 280 filmovertrukne tabletter EU/1/06/371/028 56x1 filmovertrukket tablet (enhedsdosis) EU/1/06/371/029 98x1 filmovertrukket tablet (enhedsdosis) EU/1/06/371/030 280x1 filmovertrukket tablet (enhedsdosis)
English: Each tablet contains 10 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.
Danish: Hver tablet indeholder 10 mg amlodipin (som amlodipinbesylat) og 160 mg valsartan.
English: Hyperuricaemia
Danish: Hyperurikæmi
English: Very rare* Not known
Danish: Meget sjælden*
English: Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 80 mg of valsartan.
Danish: Hver filmovertrukket tablet indeholder 5 mg amlodipin (som amlodipinbesylat) og 80 mg valsartan.
English: Each tablet contains 5 mg amlodipine (as amlodipine besylate) and 80 mg valsartan.
Danish: Hver tablet indeholder 5 mg amlodipin (som amlodipinbesylat) og 80 mg valsartan.
English: Tabulated list of adverse reactions
Danish: Skematisk oversigt over bivirkninger
English: Dizziness
Danish: Gynækomasti
English: Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan.
Danish: Hver filmovertrukket tablet indeholder 10 mg amlodipin (som amlodipinbesylat) og 160 mg valsartan.
English: Each tablet contains 5 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.
Danish: Hver tablet indeholder 5 mg amlodipin (som amlodipinbesylat) og 160 mg valsartan.
English: Visual impairment
Danish: Nedsat nyrefunktion
English: Muscle spasm
Danish: Mave-tarmkanalen
English: Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan.
Danish: Hver filmovertrukket tablet indeholder 5 mg amlodipin (som amlodipinbesylat) og 160 mg valsartan.
English: Exanthema
Danish: Eksantem
English: Flushing, hot flush
Danish: Rødme, hedeture
English: Anxiety
Danish: Palpitationer
English: Pain
Danish: Asteni
English: Gynaecomastia
Danish: Nyrearteriestenose
English: Paraesthesia
Danish: Obstipation
English: 100 x 1 tablets
Danish: 100x1 tabletter
English: Strength Pharmaceutical Form Route of Administration Packaging
Danish: Lægemiddelform
English: The recommended dose is one tablet daily.
Danish: Den anbefalede dosis er én tablet dagligt.
English: How does it work?
Danish: Hvordan virker det?
English: If patients need to stop taking one of the active substances in the medicine, or need to take different doses, they will need to change to separate individual medicines.
Danish: Hvis patienterne er nødt til at stoppe med at tage et af de aktive stoffer i lægemidlet, eller de er nødt til at tage forskellige doser, skal de skifte til separate individuelle lægemidler.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Danish: To lægemidler er bioækvivalente, når de danner den samme mængde af det aktive stof i kroppen og derfor forventes at have samme virkning.
English: It is recommended that the medicine is taken on an empty stomach, preferably at bedtime.
Danish: Det anbefales, at lægemidlet tages på tom mave og helst ved sengetid.
English: What are the benefits and risks of this medicine?
Danish: Hvilke fordele og risici er der forbundet med lægemidlet?
English: What measures are being taken to ensure the safe and effective use of this medicine?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af dette lægemiddel?
English: Treatment should be started by a doctor who has experience in the management of HIV infection.
Danish: Behandlingen bør indledes af en læge med erfaring i behandling af hivinfektion.
English: It is only used in patients whose levels of HIV in the blood (viral load) have been below 50 copies/ml for more than 3 months on their current HIV treatment combination.
Danish: Det anvendes kun til patienter, hvis koncentration af hiv i blodet (virusbelastning) har været under 50 kopier/ml i mere end tre måneder med deres nuværende hivbehandlingskombination.
English: This means that it contains the same active substances and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Atripla.
Danish: Det betyder, at det indeholder de samme aktive stoffer og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Atripla.
English: Why is the medicine approved?
Danish: Hvorfor blev lægemidlet godkendt?
English: As for every medicine, the company provided studies on its quality.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af lægemidlets kvalitet.
English: Patients should take the medicine regularly and not miss any doses.
Danish: Patienterne skal tage lægemidlet regelmæssigt og ikke springe doser over.
English: The Agency recommended that it be approved for use in the EU.
Danish: Agenturet anbefalede, at lægemidlet godkendes til anvendelse i EU.
English: It does not cure HIV infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Lægemidlet helbreder ikke hivinfektion eller aids, men kan bremse den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: It must not be used in patients in whom any previous HIV treatment combinations have not worked or have stopped working.
Danish: Det må ikke anvendes til patienter, hvor tidligere hivbehandlingskombinationer ikke har virket eller er ophørt med at virke.
English: This medicine is available as tablets and can only be obtained with a prescription.
Danish: Lægemidlet fås som tabletter og udleveres kun efter recept.
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Danish: Virksomheden gennemførte også en undersøgelse, der viste, at lægemidlet er "bioækvivalent" med referencelægemidlet.
English: The European Medicines Agency concluded that, in accordance with EU requirements, the medicine has been shown to have comparable quality and to be bioequivalent to Atripla.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at lægemidlet er af sammenlignelig kvalitet og er bioækvivalent med Atripla.
English: Also, it must not be started in patients who have ever been infected with HIV that is resistant to any of the three active substances in the medicine.
Danish: Det må heller ikke anvendes til patienter, som tidligere har været inficeret med hiv, som er resistent over for et eller flere af de tre aktive stoffer i lægemidlet.
English: All three active substances block the activity of reverse transcriptase, an enzyme that allows HIV to reproduce itself in the cells it has infected.
Danish: De tre aktivstoffer virker ved at blokere aktiviteten af revers transkriptase, som er et enzym, der gør det muligt for hivvirusset at formere sig i de celler, det har inficeret.
English: The company that markets the medicine will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with medicines containing tenofovir disoproxil such as this one.
Danish: Virksomhed, der markedsfører lægemidlet, skal sikre, at alle læger, som forventes at ordinere lægemidlet, får udleveret informationsmateriale om den øgede risiko for nyresygdom, der er forbundet med lægemidler, som indeholder tenofovirdisoproxil, herunder dette lægemiddel.
English: The educational pack also contains recommendations for monitoring kidney function in patients taking the medicine.
Danish: Informationsmaterialet skal også indeholde anbefalinger om overvågning af nyrefunktionen hos patienter, der tager lægemidlet.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
English: Therefore, the Agency's view was that, as for Atripla, the benefit outweighs the identified risk.
Danish: Det var derfor agenturets opfattelse, at fordelene opvejer de identificerede risici som for Atripla.
English: The full EPAR for Efavirenz/Emtricitabine/Tenofovir disoproxil Krka can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Efavirenz/Emtricitabine/Tenofovir disoproxil Krka findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tenofovir is a nucleotide reverse transcriptase inhibitor.
Danish: Tenofovir er en nukleotid revers transkriptasehæmmer.
English: How is the medicine used?
Danish: Hvordan anvendes lægemidlet?
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Atripla, and do not need to be repeated for Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved de aktive stoffer i den godkendte anvendelse med referencelægemidlet, Atripla, og det er ikke nødvendigt at gentage disse med Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
English: Both nucleoside and nucleotide reverse transcriptase inhibitors are commonly known as NRTIs.
Danish: Både nukleoside og nukleotide revers transkriptasehæmmere betegnes som NRTI'er.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka keeps the amount of HIV in the blood at a low level.
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka holder mængden af hiv i blodet på et lavt niveau.