FrancophonIA/ELRC3.0 huggingface dataset:
English: Draw the warm soapy water into the syringe until full and then empty completely.
Danish: Træk det varme sæbevand ind i sprøjten, indtil sprøjten er fuld og tøm den derefter helt.
English: • if you are allergic to efavirenz or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for efavirenz eller et af de øvrige indholdsstoffer i Stocrin (angivet i punkt 6).
English: The net effect of co-administration is not clear.
Danish: Nettoeffekten ved samtidig administration er ikke klarlagt.
English: Tell your doctor immediately if you feel depressed, have suicidal thoughts or have strange thoughts (see section 4, Possible side effects).
Danish: Fortæl det straks til lægen, hvis du føler dig nedtrykt, har selvmordstanker eller mærkelige tanker (se punkt 4 Bivirkninger).
English: HORMONAL CONTRACEPTIVES Oral:
Danish: ORALE KONTRACEPTIVA Oral:
English: • if you have a heart condition, such as changes in the rhythm or rate of the heart beat, a slow heart beat, or severe heart disease.
Danish: • hvis du har en hjertelidelse, såsom ændringer i hjerterytmen eller hastigheden af hjertets slag, langsomt hjerteslag eller alvorlig hjertesygdom.
English: - if you have a history of mental illness, including depression, or of substance or alcohol abuse.
Danish: - hvis du tidligere har haft en mental sygdom, herunder depression, eller stofmisbrug eller alkoholmisbrug.
English: Remove the plunger rod from the barrel and thoroughly rinse both parts with warm running water.
Danish: Fjern stemplet fra sprøjten, og skyl begge dele i varmt, rindende vand.
English: Very common (affects more than 1 user in 10) - skin rash
Danish: Meget almindelige (berører flere end 1 ud af 10 brugere) - Hududslæt
English: In the study of 57 children, 3.5 % of patients experienced nervous system symptoms of moderate intensity, predominantly dizziness.
Danish: I en undersøgelse, der omfattede 57 børn, oplevede 3,5% symptomer fra nervesystemet af moderat intensitet, fortrinsvis svimmelhed.
English: Treatment Regimen
Danish: Behandlingsregime
English: In addition, your doctor may prescribe a higher dose of Stocrin.
Danish: Desuden vil lægen måske ordinere en højere dosis Stocrin.
English: - if you have a history of liver disease, including active chronic hepatitis.
Danish: - hvis du tidligere har haft leversygdom, herunder aktiv kronisk hepatitis.
English: The incidence of erythema multiforme or Stevens-Johnson syndrome was approximately 0.1 %.
Danish: Incidensen af erythema multiforme eller Stevens-Johnsons syndrom var ca. 0,1%.
English: As a result, the amounts of Stocrin or other medicines in your blood may be affected.
Danish: Derfor kan mængden af Stocrin eller anden medicin i blodet blive påvirket.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Hvis din læge har fortalt dig, at du ikke kan tåle visse sukkerarter, skal du kontakte lægen, før du anvender denne medicin.
English: You must not take Stocrin with certain medicines.
Danish: Du må ikke tage Stocrin sammen med visse former for medicin.
English: Pharmacotherapeutic group: Antivirals for systemic use.
Danish: Farmakoterapeutisk klassifikation: Antivirale lægemidler til systemisk brug.
English: • Stocrin must be taken with other medicines that act against the HIV virus.
Danish: • Stocrin skal tages sammen med andre lægemidler, der virker mod hiv-virus.
English: Responder rates (NC = F Plasma HIV-RNA
Danish: Responshyppigheder (NC = F Plasma hiv-RNA
English: If you had a rash while taking another NNRTI, you may be at a higher risk of getting a rash with Stocrin.
Danish: Hvis du får udslæt, mens du tager en anden NNRTI, kan du have større risiko for at få udslæt med Stocrin.
English: The dose of Stocrin oral solution in mg is not the same as for Stocrin film-coated tablets.
Danish: Dosis for Stocrin oral opløsning i mg er ikke den samme som for Stocrin filmovertrukne tabletter.
English: • Separate the syringe from the adapter.
Danish: • Fjern sprøjten fra adapteren.
English: Taking these medicines with Stocrin could create the potential for serious and/or life-threatening side-effects or stop Stocrin from working properly.
Danish: Hvis du tager disse lægemidler sammen med Stocrin, kan der opstå alvorlige og/eller livstruende bivirkninger, eller Stocrin kan holde op med at virke på den rigtige måde.
English: - bone problems.
Danish: - knogleproblemer.
English: If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant medicine in your blood to ensure that it is not affected while taking Stocrin.
Danish: Hvis du får noget af denne medicin, kan det være nødvendigt, at lægen kontrollerer mængden af denne medicin i dit blod for at sikre, at denne ikke påvirkes af, at du tager Stocrin.
English: Lopinavir concentrations:
Danish: Lopinavirkoncentrationer:
English: Non-nucleoside reverse transcriptase inhibitors.
Danish: Non-nukleoside reverse transkriptasehæmmere.
English: cells/mm 3 (S.E.M.
Danish: celler/mm 3 (S.E.M.
English: The starting dose of efavirenz was the equivalent of a 600 mg dose (adjusted from calculated body size based on weight).
Danish: Initialdosis af efavirenz svarede til en dosis på 600 mg (justeret efter kalkuleret kropsstørrelse baseret på vægt).
English: It is an antiretroviral medicine that fights human immunodeficiency virus (HIV) infection by reducing the amount of the virus in blood.
Danish: Det er en antiretroviral medicin, som bekæmper humant immundefektvirus (hiv)-infektion ved at reducere mængden af virus i blodet.
English: Patients should be informed that if they do occur, these common symptoms are likely to improve with continued therapy and are not predictive of subsequent onset of any of the less frequent psychiatric symptoms.
Danish: Patienterne bør informeres om, at disse almindelige bivirkninger sandsynligvis bedres ved fortsat behandling, og at de ikke er indikatorer for, at der efterfølgende vil opstå nogle af de mindre hyppige psykiske symptomer.
English: Consider alternatives to efavirenz for co-administration with a drug with a known risk of Torsade de Pointes or when to be administered to patients at higher risk of Torsade de Pointes.
Danish: Overvej alternativer til efavirenz, når dette administreres sammen med et lægemiddel med kendt risiko for torsade de pointes, eller når det administreres til patienter med høj risiko for at få torsade de pointes.
English: While the carcinogenic potential in humans is unknown, these data suggest that the clinical benefit of efavirenz outweighs the potential carcinogenic risk to humans.
Danish: Selvom karcinogenicitetspotentialet hos mennesker ikke er kendt, antyder disse data at efavirenz' kliniske fordele opvejer den mulige karcinogenicitet hos mennesker.
English: Press the plunger slowly to allow time for the medicine to be swallowed.
Danish: Tryk langsomt på stemplet, så patienten får tid til at synke medicinen.
English: - severe depression - suicidal ideation - non-fatal suicide attempts - aggressive behaviour - paranoid reactions - manic reactions
Danish: - Svær depression - Suicidale tanker - Ikke-dødelige selvmordsforsøg 0,4% - Aggresiv adfærd - Paranoide reaktioner - Maniske reaktioner
English: Efavirenz is a non-competitive inhibitor of HIV-1 reverse transcriptase (RT) and does not significantly inhibit HIV-2 RT or cellular DNA polymerases (, ,  or ).
Danish: Efavirenz er en nonkompetetiv hæmmer af hiv-1 reverse transkriptase (RT) og hæmmer ikke signifikant hiv-2 RT eller cellulære DNA-polymeraser (, ,  eller ).
English: In the analysis of responder rates (the non-completer equals failure analysis [NC = F]), patients who terminated the study early for any reason, or who had a missing HIV-RNA measurement that was either preceded or followed by a measurement above the limit of assay quantification were considered to have HIV-RNA above 50 or above 400 copies/ml at the missing time points.
Danish: I analysen af responsraten (non-completer lig med failure analysen[NC = F]), blev patienter, der udgik af studiet tidligt uanset grund, patienter som manglede en hiv-RNA måling, som enten var forudgået eller blev efterfulgt af en måling over assaygrænsen, formodet at have hiv-RNA over 50 eller over 400 kopier/ml på de manglende tidspunkter.
English: 3 and the mean baseline HIV-RNA level was 60,250 copies/ml.
Danish: 3, og gennemsnitligt hiv-RNA niveau var 60.250 kopier/ml.
English: Your doctor may conduct blood tests in order to check how well your liver is working or may switch you to another medicine.
Danish: Lægen vil måske tage blodprøver for at kontrollere, hvor godt din lever virker eller måske skifte dig til anden medicin.
English: Adults and children aged 5 years or more
Danish: Voksne og børn over 5 år
English: 3, or in PI or NNRTI-experienced patients.
Danish: 3 eller med PI- eller NNRTI-erfarne patienter.
English: Co-administration of higher doses of either efavirenz or carbamazepine has not been studied.
Danish: Samtidig administration af højere doser af enten efavirenz eller carbamazepin er ikke undersøgt.
English: In a single-dose study, half life was doubled in the single patient with severe hepatic impairment (Child-Pugh Class C), indicating a potential for a much greater degree of accumulation.
Danish: I en undersøgelse med enkeltdosering blev halveringstiden fordoblet hos den enkelte patient med svær leverinsufficiens (Child Pugh klasse C), hvilket indikerer en risiko for en langt større grad af akkumulering.
English: Colourless to slightly yellow clear liquid.
Danish: Farveløs til svagt gul, klar væske.
English: Allow the parts to dry completely prior to reassembly.
Danish: Lad delene tørre helt, før sprøjten samles igen.
English: Information regarding post-marketing surveillance These adverse reactions were identified through post-marketing surveillance; however, the frequencies were determined using data from 16 clinical trials (n=3,969).
Danish: Oplysninger vedrørende overvågning efter markedsføring Disse bivirkninger blev identificeret efter markedsføring; hyppigheden er dog bestemt på baggrund af data fra 16 kliniske undersøgelser (n=3.969).
English: Dose (ml)
Danish: Dosis (ml)
English: Turn the bottle the right way up and remove the syringe.
Danish: Vend flasken rigtigt, og fjern sprøjten.
English: Resistant virus emerges rapidly when efavirenz is administered as monotherapy.
Danish: Resistent virus forekommer hurtigt, når efavirenz administreres som monoterapi.
English: If you take too much Stocrin contact your doctor or nearest emergency department for advice.
Danish: Hvis du har taget for meget Stocrin, skal du henvende dig til din læge eller nærmeste skadestue for at få rådgivning.
English: Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI based combination therapy after failure of regimens containing STOCRIN.
Danish: Selvom der ikke er dokumenteret krydsresistens mellem efavirenz og PI'ere, er der i øjeblikket ikke tilstrækkelige data med hensyn til effekten af efterfølgende brug af PI-baseret kombinationsbehandling efter svigtende effekt af regimer, der inkluderer STOCRIN.
English: Currently available data are described in sections 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Danish: 4.8, 5.1 og 5.2, men der kan ikke gives en anbefaling til dosering.
English: The response rate, based on the NC = F analysis of the percentage of patients with plasma HIV-RNA < 400 copies/ml at 48 weeks was 60 % (95 %, C.I.
Danish: Responshyppigheden, der er baseret på NC = F analyse af den procentdel af patienter med plasma hiv-RNA  400 kopier/ml efter 48 uger var 60% (95%, C.I.
English: Antibiotics, including the following types: macrolides, fluoroquinolones or imidazole.
Danish: - Antibiotika herunder følgende typer: makrolider, fluoroquinoloner eller imidazol.
English: • The dose for children weighing less than 40 kg is calculated by body weight and is taken once daily as shown below:
Danish: • Dosis til børn, der vejer mindre end 40 kg, beregnes efter legemsvægt og tages 1 gang dagligt som vist nedenfor:
English: These adverse reactions were identified through post-marketing surveillance but not reported as drug-related events for efavirenz-treated patients in 16 clinical trials.
Danish: Disse bivirkninger blev identificeret efter markedsføring, men blev ikke indberettet som lægemiddelrelaterede hændelser hos efavirenzbehandlede patienter i 16 kliniske undersøgelser.
English: The potential for cross-resistance between efavirenz and NRTIs is low because of the different binding sites on the target and mechanism of action.
Danish: Potentialet for krydsresistens mellem efavirenz og NRTIre er lille på grund af de forskellige bindingssteder på målet og virkningsmekanismen.
English: It contains: lactose monohydrate.
Danish: Den indeholder: Lactosemonohydrat.
English: Although nervous system symptoms are difficult for young children to report, they appear to be less frequent in children and were generally mild.
Danish: Skønt det er svært at vurdere symptomer i nervesystemet hos yngre børn, synes frekvensen at være mindre hos børn, og symptomerne var generelt milde.
English: The durability of the response was similar to that seen in adult patients.
Danish: Varigheden af respons lignede varigheden af respons hos voksne patienter.
English: • To measure the dose accurately, keep the bottle upside down and push the plunger in slowly until the top of the black ring (the edge nearest the syringe tip) lines up with the dose.
Danish: • For nøjagtig dosering holdes flasken med bunden opad, mens stemplet skubbes langsomt ned, indtil toppen af den sorte stempelring (enden tættest på sprøjtens spids) er ud for den ønskede dosis.
English: 40, 66) based on percentage of patients with plasma HIV-RNA < 50 copies/ml.
Danish: 40, 66), der er baseret på procentdelen af patienter med plasma hiv-RNA  50 kopier/ml.
English: Efficacy results for study 006 on a subset of 614 patients who had been enrolled for at least 48 weeks are found in Table 3.
Danish: I Tabel 3 ses effektresultaterne for Undersøgelse 006, for en undergruppe af 614 patienter, som havde været inkluderet i mindst 48 uger.
English: No effect (↔) equals a decrease in mean ratio estimate of ≤20% or increase in mean ratio estimate of
Danish: Ingen indvirkning (↔) svarer til et fald i estimeret gennemsnitsratio på ≤20% eller stigning i estimeret gennemsnitsratio på
English: The methadone dose was increased by a mean of 22 % to alleviate withdrawal symptoms.
Danish: Methadondosis øgedes med gennemsnitligt 22% for at mildne abstinenssymptomerne.
English: 13 to < 15 15 to < 20 20 to < 25 25 to < 32.5 32.5 to < 40
Danish: 13 til < 15 15 til < 20 20 til < 25 25 til < 32,5 32,5 til < 40
English: The pattern of amino acid substitutions in RT associated with resistance to efavirenz was independent of the other antiviral medicinal products used in combination with efavirenz.
Danish: Mønstret for aminosyresubstitutioner i RT, der er forbundet med resistens over for efavirenz, var uafhængigt af de andre antiviralelægemidler, der anvendtes i kombination med efavirenz.
English: If parts of the syringe are not clean, repeat the cleaning instructions.
Danish: Hvis dele af sprøjten ikke er rene, følg da rengøringsinstruktionen forfra igen.
English: This mutation was observed in 90 % of patients receiving efavirenz with virological failure.
Danish: Denne mutation blev observeret hos 90% af de patienter, som fik efavirenz, og som havde virologisk svigt.
English: atovaquone/proguanil: Stocrin may reduce the amount of atovaquone/proguanil in your blood.
Danish: atovaquon/proguanil: Stocrin kan nedsætte mængden af atovaquon/proguanil i blodet.
English: Confirmatory testing by a more specific method such as gas chromatography/mass spectrometry is recommended in such cases.
Danish: I sådanne tilfælde anbefales det at udføre bekræftende analyser med en mere specifik metode, såsom gaskromatografi/massespektrometri.
English: For this reason, efavirenz oral solution should not be given to children less than 3 years of age.
Danish: Af denne grund bør efavirenz oral opløsning ikke gives til børn under 3 år.
English: Effects on drug levels Mean percent change in AUC, Cmax, Cmin with confidence intervals if available (mechanism)
Danish: Indvirkning på lægemiddelkoncentrationen, gennemsnitlig ændring (%) i AUC, Cmax, Cmin med konfidensintervaller hvis muligt a (mekanisme)
English: 90 % confidence intervals unless otherwise noted.
Danish: 90% konfidensinterval med mindre andet er angivet.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med sjældne, arvelige sygdomme som galactoseintolerance, en særlig form for lactasemangel (Lapp Lactase deficiency) eller glucose/galactose malabsorptionssyndrom bør ikke tage dette lægemiddel.
English: Therefore, efavirenz should not be given to children less than 3 years of age.
Danish: Derfor bør efavirenz ikke gives til børn under 3 år.
English: Patients with a prior history of psychiatric disorders appear to be at greater risk of these serious psychiatric adverse reactions.
Danish: Patienter med psykiske lidelser i anamnesen synes at have større risiko for disse alvorlige psykiske bivirkninger.
English: In the long-term study (006), 1 % of patients in each treatment arm discontinued because of liver or biliary system disorders.
Danish: I langtidsundersøgelsen (006) afbrød 1% af patienterne i hver af behandlingsarmene behandlingen pga. problemer fra lever eller galdeveje.
English: With efavirenz, an increase of the lopinavir/ritonavir soft capsule or oral solution doses by 33 % should be considered (4 capsules/~6.5 ml twice daily instead of 3 capsules/5 ml twice daily).
Danish: Sammen med efavirenz bør en øgning af dosis for lopinavir/ritonavir blød kapsel eller oral opløsning på 33% overvejes (4 kapsler/~ 6,5 ml to gange dagligt i stedet for 3 kapsler/5 ml to gange dagligt).
English: Your doctor will give you instructions for proper dosing.
Danish: Din læge vil informere dig om den rette dosering.
English: This may make some side effects (for example, dizziness, drowsiness) less troublesome.
Danish: Dette kan få nogle bivirkninger (fx svimmelhed, døsighed) til at virke mindre generende.
English: - signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating or abnormal dreaming.
Danish: - tegn på svimmelhed, søvnbesvær, døsighed, besvær med at koncentrere sig eller unormale drømme.
English: S.E.M., standard error of the mean.
Danish: S.E.M., Standard afvigelse på middelværdi
English: Outer carton: 2D barcode carrying the unique identifier included.
Danish: Ydre pakning: Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: Put the tip of the syringe just inside the mouth, pointing it towards the cheek.
Danish: Anbring lige akkurat sprøjtens spids inde i patientens mund, således at sprøjten peger mod indersiden af kinden.
English: cells/mm (S.E.M.
Danish: Celler/mm (S.E.M.)
English: If you stop taking Stocrin
Danish: Hvis du holder op med at tage Stocrin
English: In one study, nervous system symptoms often occurred during the first 1-3 hours after taking a dose.
Danish: I en undersøgelse opstod symptomerne fra nervesystemet ofte i løbet af de første 1-3 timer efter indtagelse af en dosis.
English: Table 1 Paediatric dose to be administered once daily
Danish: Tabel 1 Pædiatrisk dosis til indgivelse 1 gang dagligt
English: Telaprevir (relative to 750 mg q8h):
Danish: Telaprevir (i forhold til 750 mg q8h):
English: If you see any signs of a severe rash with blistering or fever, stop taking Stocrin and tell your doctor at once.
Danish: Hvis du har tegn på alvorligt hududslæt med blæredannelse eller feber, skal du stoppe med at tage Stocrin og straks fortælle det til lægen.
English: c) % (95 % C.I.)
Danish: ) % (95% C.I.)
English: *lower than recommended doses, similar findings are expected with recommended doses.
Danish: *lavere end anbefalede doser.
English: Stocrin is not recommended for children under the age of 3 years or weighing less than 13 kg because it has not been adequately studied in these patients.
Danish: Stocrin anbefales ikke til børn under 3 år, eller som vejer mindre end 13 kg, da det ikke er undersøgt i tilstrækkelig grad hos disse patienter.
English: If you forget to take Stocrin
Danish: Hvis du har glemt at tage Stocrin
English: Approximately 14 - 34 % of a radiolabelled dose of efavirenz was recovered in the urine and less than 1 % of the dose was excreted in urine as unchanged efavirenz.
Danish: Ca. 14 - 34% af en isotopmærket dosis af efavirenz blev genfundet i urinen, og mindre end 1% af dosis blev udskilt i urinen som uomdannet efavirenz.
English: • On first use, the bottle adapter must be fitted into the neck of the bottle.
Danish: • Ved anvendelse første gang anbringes flaskeadapteren i flaskens hals.
English: The mean baseline CD4 cell count was 341 cells/mm
Danish: Det gennemsnitlige CD4 celletal ved baseline var 341 celler/mm
English: Stocrin, which contains the active substance efavirenz, belongs to a class of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Danish: Stocrin, der indeholder den aktive substans efavirenz, hører til den antiretrovirale medicingruppe, som kaldes non-nukleoside reverse transkriptasehæmmere (NNRTI).
English: Stocrin must always be taken in combination with other anti-HIV medicines.
Danish: Stocrin skal altid tages sammen med andre anti-hiv-lægemidler.
English: In a 3-month drug interaction study, no significant differences in MPA pharmacokinetic parameters were found between subjects receiving efavirenzcontaining antiretroviral therapy and subjects receiving no antiretroviral therapy.
Danish: I en 3-måneders interaktionsundersøgelse af lægemidlerne sås ingen signifikante forskelle i MPA's farmakokinetiske parametre mellem de forsøgspersoner, der fik antiretroviral behandling indeholdende efavirenz og de forsøgspersoner, der ikke fik antiretroviral behandling.
English: If you have taken Stocrin or the combination tablet containing efavirenz, emtricitabine, and tenofovir during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: Hvis du har taget Stocrin eller kombinationstabletten med efavirenz, emtricitabin og tenofovir under graviditeten, kan lægen bede om regelmæssige blodprøver og andre diagnostiske prøver for at kontrollere barnets udvikling.
English: Two of three delavirdine-resistant clinical isolates examined were cross-resistant to efavirenz and contained the K103N substitution.
Danish: To ud af tre undersøgte delavirdinresistente, kliniske isolater var krydsresistente over for efavirenz og indeholdt K103N-substitutionen.
English: Stocrin 30 mg/ml oral solution is supplied in bottles of 180 ml.
Danish: Stocrin 30 mg/ml oral opløsning fås i flasker med 180 ml.
English: The pharmacokinetics of efavirenz in paediatric patients were similar to adults.
Danish: Efavirenz' farmakokinetik hos pædiatriske patienter var den samme som hos voksne.
English: Rare (affects 1 to 10 users in 10,000) - itchy rash caused by a reaction to sunlight - liver failure, in some cases leading to death or liver transplant, has occurred with efavirenz.
Danish: Sjældne (berører 1 til 10 ud af 10.000 brugere) - Kløende udslæt som en reaktion på sollys - Leversvigt, som i nogle tilfælde kan føre til død eller levertransplantation, er forekommet sammen med efavirenz.
English: It is important to tell your doctor or pharmacist if you are taking any of the following:
Danish: Det er vigtigt, at du fortæller det til lægen eller til apotekspersonalet, hvis du tager følgende:
English: - severe disturbances of electrolyte balance e.g. hypokalaemia or hypomagnesaemia.
Danish: - alvorlig forstyrrelse af elektrolytbalancen, fx hypokaliæmi eller hypomagnesiæmi.