FrancophonIA/ELRC3.0 huggingface dataset:
English: Also read the list of medicines under ‘Other medicines and Norvir' for use with certain other medicines which require special care.
Danish: Læs også listen over lægemidler under punktet ‘Brug af anden medicin sammen med Norvir' til anvendelse sammen med visse andre lægemidler, som kræver, at der udvises særlig forsigtighed.
English: Thyroid-stimulating hormone (TSH) should be monitored in patients treated with levothyroxine at least the first month after starting and/or ending ritonavir treatment.
Danish: Thyroidea-stimulerende hormon (TSH) skal som minimum monitoreres hos patienter i behandling med levothyroxin den første måned efter start og/eller afslutning på ritonavir-behandling.
English: Adverse reactions in clinical studies and post-marketing in adult patients System Order Class
Danish: Bivirkninger i kliniske studier og postmarketing hos voksne patienter Systemorganklasse
English: However, these warnings may also apply when Norvir is used in lower doses (a booster) with other medicines.
Danish: Advarslerne kan dog også gælde i tilfælde, hvor Norvir tages i lavere doser (boosterdoser) sammen med andre lægemidler.
English: There is a large amount of information on the use of ritonavir (the active ingredient in Norvir) during pregnancy.
Danish: Der findes en stor mængdeaf oplysninger om brugen af ritonavir (det aktive stof i Norvir) under graviditet.
English: Be careful not to pull the plunger out.
Danish: Pas på ikke at trække stemplet ud.
English: These data indicate no increase in the rate of birth defects compared to rates observed in population-based birth defect surveillance systems.
Danish: Disse data indikerer ingen øget forekomst af medfødte defekter sammenlignet med forekomsten fundet i populationsbaserede overvågningssystemer af fødselsdefekter.
English: Amlodipine, diltiazem, nifedipine
Danish: Amlodipin, diltiazem, nifedipin
English: Norvir is used by children 2 years of age or older, adolescents and adults who are infected with HIV, the virus which causes AIDS.
Danish: Norvir bruges til børn på 2 år og derover, unge og voksne, som er inficeret med hiv, den virus som forårsager AIDS.
English: Be careful not to spill any powder outside of the mixing cup (see Figure 6).
Danish: Pas på ikke at spilde noget pulver ved siden af blande-koppen (se figur 6).
English: The protein binding of ritonavir in human plasma is approximately 98 - 99% and is constant over the concentration range of 1.0 - 100 µg/ml.
Danish: Ritonavirs binding til humane plasmaproteiner er ca. 98-99% og er konstant inden for koncentrationsområdet 1,0 - 100 µg/ml.
English: • Let the liquid stand for 10 minutes in order for most of the bubbles to disappear.
Danish: • Lad væsken stå i10 minutter for at få de fleste af boblerne til at forsvinde.
English: The dose and/or frequency of use of these medicines may need to be reduced to avoid hypotension and prolonged erection.
Danish: Det kan være nødvendigt at nedsætte dosis og/eller hyppigheden af brugen af disse lægemidler for at undgå hypotension og forlænget erektion.
English: Co-administration with Norvir may cause a large increase in the concentration of this benzodiazepine.
Danish: Samtidig administration af Norvir kan forårsage en stor stigning i koncentrationen af dette benzodiazepin.
English: SPECIAL STORAGE CONDITIONS Store below 30°C 10.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares under 30°C
English: The effect of ritonavir on rifampicin is not known.
Danish: Ritonavirs effekt på rifampicin kendes ikke.
English: Norvir may experience changes in the electrocardiogram (ECG).
Danish: Norvir kan få ændringer i elektrokardiogram (ekg).
English: d. Let the liquid stand for 10 minutes and most of the bubbles will disappear.
Danish: d. Lad væsken stå i 10 minutter, og herefter vil de fleste af boblerne være forsvundet.
English: Clarithromycin 14-OH clarithromycin metabolite
Danish: Clarithromycin 14-OH-clarithromycin metabolit
English: If powder residue is left, add more spoonfuls of food and serve to patient.
Danish: Hvis der er en rest pulver tilbage, tilføjes flere skefulde med mad og det gives til patienten.
English: If you do need more than 1 sachet, repeat all the steps with each sachet.
Danish: Hvis du har brug for mere end 1 brev, gentages alle trin med hvert brev.
English: For doses less than 100 mg amounts or doses between 100 mg amounts, the content of the entire sachet is to be mixed with a liquid and then dosed by the appropriate ml volume as told to you by your doctor using the oral dosing syringe.
Danish: For doser mindre end 100 mg eller doser, som ligger imellem 100 mg mængderne, blandes hele indholdet af hvert brev med en væske og herefter doseres med det relevante ml volumen, som din læge har fortalt dig ved brug af den orale doseringssprøjte.
English: Special attention should be given to the accurate calculation of the dose of Norvir, transcription of the medication order, dispensing information and dosing instructions to minimise the risk for medication errors and underdose.
Danish: Der skal udvises særlig opmærksomhed ved nøjagtig beregning af Norvir-dosis, overførsel af medicinordinationer, information om dispensering og doseringsinstruktioner for at minimerer risikoen for medicineringsfejl og underdosering.
English: The signs of toxicity observed in animals (mice and rats) included decreased activity, ataxia, dyspnoea and tremors.
Danish: De tegn på toksicitet, der blev observeret hos dyr (mus og rotter), omfattede nedsat aktivitet, ataksi, dyspnø og tremor.
English: On rare occasions these muscle disorders have been serious.
Danish: Muskellidelserne har i sjældne tilfælde været alvorlige.
English: Concomitant administration of glecaprevir/pibrentasvir and Norvir is not recommended due to an increased risk of ALT elevations associated with increased glecaprevir exposure.
Danish: Samtidig administration af glecaprevir/pibrentasvir og Norvir anbefales ikke på grund af øget risiko for ALT-stigninger forbundet med øget eksponering for glecaprevir.
English: Due to the risk of severe hepatoxicity, saquinavir/ritonavir should not be given together with rifampicin.
Danish: På grund af risikoen for alvorlig levertoxicitet, bør saquinavir/ritonavir ikke gives sammen med rifampicin.
English: Events noted as having frequency not known were identified via post-marketing surveillance.
Danish: Bivirkninger, der er registreret med ikke kendt hyppighed, blev identificeret i forbindelse med postmarketing overvågning.
English: If Norvir is co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Danish: Hvis Norvir administreres samtidig med parenteral midazolam, bør det gøres på en intensivafdeling (ICU) eller under lignende forhold, der sikrer tæt klinisk monitorering og passende medicinsk behandling i tilfælde af respirationsdepression og/eller forlænget sedation.
English: ENTIRE serving must be eaten (see Figure 6).
Danish: HELE portionen skal spises (se figur 6).
English: Follow the instructions for the feeding tube to administer the medicine.
Danish: Følg instruktionerne for ernæringssonden ved administration af lægemidlet.
English: Trough concentrations of ritonavir decrease over time, possibly due to enzyme induction, but appeared to stabilise by the end of 2 weeks.
Danish: De laveste koncentrationer af ritonavir falder med tiden, muligvis på grund af enzyminduktion, men syntes at stabilisere sig efter 2 uger.
English: - Symptoms of infection - inform your doctor immediately.
Danish: − symptomer på infektion - informér omgående din læge.
English: • you cannot clean the syringe
Danish: • du ikke kan rengøre sprøjten
English: Talk to your doctor before you take any cholesterol-reducing medicines with Norvir (see also ‘Do not take Norvir' above).
Danish: Tal med din læge, inden du tager nogen former for kolesterolsænkende lægemidler sammen med Norvir (se også punktet ‘Tag ikke Norvir' ovenfor).
English: Maraviroc may be given with ritonavir to increase the maraviroc exposure.
Danish: Maraviroc kan gives sammen med ritonavir for at øge ekspositionen af maraviroc.
English: β2-agonist (long acting)
Danish: Beta2-agonister (langtidsvirkende)
English: e. Slowly push the plunger until you see a small amount of liquid at the tip of the syringe.
Danish: e. Tryk langsomt stemple indtil du ser en lille smule væske på spidsen af sprøjten.
English: • Use the provided oral dosing syringe to measure and administer the prescribed ml volume (see section 4.2).
Danish: • Brug den medfølgende orale doseringssprøjte til at afmåle og administrere det foreskrevne ml volumen (se pkt.
English: See section 4.4 and section 4.5 for co-administration of sildenafil in patients with erectile dysfunction.
Danish: Se punkt 4.4 og punkt 4.5 vedrørende samtidig indgift af sildenafil til patienter med erektil dysfunktion.
English: • The entire contents of each sachet is to be poured over a small amount of soft food (e.g. apple sauce or vanilla pudding).
Danish: • Hele indholdet af hvert brev skal hældes på en lille smule blød mad (f.eks. æblemos eller vanille budding).
English: Renal clearance averaged less than 0.1 l/h and was relatively constant throughout the dosage range.
Danish: Nyreclearance udgjorde i gennemsnit mindre end 0,1 l/t og var relativt konstant i doseringsintervallet.
English: Rifabutin1 25-O-desacetyl rifabutin metabolite
Danish: Rifabutin1 25-O-desacetyl-rifabutin metabolit
English: Norvir is not recommended in children below 2 years of age due to lack of data on safety and efficacy.
Danish: Norvir bør ikke anvendes til børn under 2 år pga. utilstrækkelige data vedrørende sikkerhed og virkning.
English: In an interaction study of single-dose bedaquiline and multiple dose lopinavir/ritonavir, the AUC of bedaquiline was increased by 22%.
Danish: I et interaktionsstudie med enkelt-dosis bedaquilin og fler-dosis lopinavir/ritonavir blev AUC for bedaquilin øget med 22%.
English: There are medicines that may not mix with Norvir because their effects could increase or decrease when taken together.
Danish: Der er lægemidler, som helst ikke skal blandes med Norvir, fordi deres virkning kan øges eller falde, når de tages sammen.
English: Rinse and allow to air dry.
Danish: Skyl og lad det lufttørre.
English: After ritonavir use for 10 days, no inhibitory effect of ritonavir was observed.
Danish: Efter anvendelse af ritonavir i 10 dage, blev der ikke set nogen hæmmende effekt på ritonavir.
English: Cyclosporine, tacrolimus, everolimus
Danish: Ciclosporin, tacrolimus, everolimus
English: Ritonavir-resistant isolates of HIV-1 have been selected in vitro and isolated from patients treated with therapeutic doses of ritonavir.
Danish: Ritonavir-resistente isolater af hiv-1 er blevet selekteret in vitro og isoleret fra patienter i behandling med terapeutiske doser af ritonavir.
English: Human studies with radiolabelled ritonavir demonstrated that the elimination of ritonavir was primarily via the hepatobiliary system; approximately 86% of radiolabel was recovered from stool, part of which is expected to be unabsorbed ritonavir.
Danish: Humane studier med radiomærket ritonavir har vist, at udskillelsen af ritonavir hovedsagelig sker via lever-/galdesystemet; ca. 86 % af radiomærkningen blev genfundet i fæces, hvoraf en del anses for at være uabsorberet ritonavir.
English: Norvir contains the active substance ritonavir.
Danish: Norvir indeholder det aktive stof ritonavir.
English: Hormonal contraceptive
Danish: Hormonale kontraceptiva
English: Based on a parallel group comparison
Danish: Baseret på en parallelgruppesammenligning.
English: Packaged with a mixing cup and two 10 ml calibrated oral dosing syringes.
Danish: Pakket med en blandekop og to 10 ml kalibrerede orale doseringssprøjter.
English: − sildenafil if you suffer from a lung disease called pulmonary arterial hypertension that makes breathing difficult.
Danish: − sildenafil, hvis du har en lungesygdom kaldet pulmonal hypertension, der vanskeliggør vejrtrækningen.
English: Contraindicated when used for the treatment of pulmonary arterial hypertension (PAH) only.
Danish: Kontraindiceret, når det anvendes til behandling af pulmonal hypertension (PAH).
English: Breastfeeding Limited published data reports that ritonavir is present in human milk.
Danish: Amning Begrænsede offentliggjorte data rapporterer, at ritonavir er til stede i modermælk.
English: Norvir is used in combination with other anti-HIV medicines (antiretrovirals) to control your HIV infection.
Danish: Norvir anvendes i kombination med andre lægemidler mod hiv (antiretrovirale lægemidler) til at kontrollere hiv-infektion.
English: Ritonavir should be administered by physicians who are experienced in the treatment of HIV infection.
Danish: Ritonavir bør ordineres af en læge, der har erfaring med behandling af hiv-infektioner.
English: The mean changes from baseline in PR interval ranged from 11.0 to 24.0 msec in the 12 hour interval post dose.
Danish: De gennemsnitlige ændringer i PR-interval fra baseline strækker sig fra 11,0 til 24,0 msek i et interval på 12 timer efter dosen.
English: Norvir tablets should be taken with food.
Danish: Norvir-tabletter bør indtages sammen med mad.
English: Inform your doctor as soon as possible if you experience any symptoms that suggest an allergic reaction after taking Norvir such as rash, hives or breathing difficulties.
Danish: Fortæl det straks til din læge, hvis du oplever symptomer, som tyder på en allergisk reaktion, efter indtagelse af Norvir, f.eks. udslæt, nældefeber eller åndedrætsbesvær.
English: No medicinal product interaction study has been performed for the co-administration of Norvir with benzodiazepines.
Danish: Der er ikke udført interaktionsstudier med samtidig administration af Norvir med benzodiazepiner.
English: • Draw up 9.4 ml of liquid using the provided oral dosing syringe, remove the bubbles, and transfer the liquid to the mixing cup.
Danish: • Træk 9,4 ml væske op ved hjælp af den medfølgende orale doseringssprøjte, fjern bobler, og overfør væske til blande-koppen.
English: Alprazolam metabolism was inhibited following the introduction of ritonavir.
Danish: Metabolismen af alprazolam blev hæmmet efter introduction af ritonavir.
English: Body Surface Area (m2)
Danish: Kroppens overflade (m2)*
English: If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Danish: Hvis du bemærker nogen symptomer på infektion eller andre symptomer såsom muskelsvaghed, svaghed som starter i hænder og fødder og bevæger sig op gennem kroppen, hjertebanken, kramper eller hyperaktivitet, skal du omgående kontakte din læge for at få den nødvendige behandling.
English: Norvir should be used with caution in such patients (see section 5.1).
Danish: Norvir bør bruges med forsigtighed til sådanne patienter (se pkt.
English: Norvir is not recommended in children below 2 years of age.
Danish: Norvir anbefales ikke til børn under 2 år.
English: Put a small serving of soft food (applesauce or vanilla pudding) in a cup (see Figure 2).
Danish: Anbring en lille mængde blød mad (æblemos eller vanille budding) i en kop (se figur
English: Norvir film-coated tablets are white debossed with [Abbott logo] and the code “NK”.
Danish: Norvir filmovertrukne tabletter er hvide, præget med [Abbott logo] og koden ‘NK'.
English: Data from concomitant use of parenteral midazolam with other protease inhibitors suggest a possible 3 - 4 fold increase in midazolam plasma levels.
Danish: Data fra samtidig anvendelse af parenteral midazolam med andre protease-hæmmere tyder på en mulig stigning på 3 - 4 gange i plasmaniveauerne for midazolam.
English: Taking Norvir as recommended should give you the best chance of delaying resistance to the medicines.
Danish: Ved at tage Norvir som det er ordineret, har du størst chance for at forsinke udviklingen af resistens mod lægemidlerne.
English: In some cases fatalities have been observed.
Danish: I nogle tilfælde er der observeret letale forløb.
English: Delavirdine1
Danish: Delavirdin1
English: Uncommon Increased glucose, increased magnesium, increased alkaline phosphatase
Danish: Ikke almindelig Forhøjet glucose, forhøjet magnesium, forhøjet alkalisk fosfatase
English: days
Danish: dage
English: • Pour the entire contents of 1 sachet (100 mg) into the mixing cup.
Danish: • Hæld hele indholdet af 1 brev (100 mg) ned i blande-koppen.
English: In this instance, close clinical monitoring is warranted.
Danish: Tæt klinisk overvågning er berrettiget.
English: It is therefore important that you remain under the supervision of your doctor while taking Norvir.
Danish: Det er derfor vigtigt, at din læge følger dig nøje, mens du tager Norvir.
English: Dosage conversion from powder for oral suspension to tablets for children
Danish: Doseringskonvertering fra pulver til oral suspension til tabletter til børn
English: • the syringe is damaged or leaking.
Danish: • sprøjten er beskadiget eller utæt.
English: Therefore, Norvir should not be co-administered with orally administered midazolam (see section 4.3), whereas caution should be used with co-administration of Norvir and parenteral midazolam.
Danish: Norvir bør derfor ikke administreres samtidig med oralt administreret midazolam (se pkt 4.3), hvorimod der bør udvises forsigtighed ved samtidig administration af Norvir og parenteral midazolam.
English: Administering with liquid The entire contents of each sachet should be suspended in 9.4 ml of liquid (water, chocolate milk, or infant formula) giving a final concentration of 10 mg per ml.
Danish: Administration med væske Hele indholdet af hvert brev skal blandes i 9,4 ml væske (vand, kakaomælk eller modermælkerstatning), hvilket giver en endelig koncentration på 10 mg pr. ml.
English: People with liver disease or hepatitis may have worsening of liver disease.
Danish: Patienter med leversygdom eller hepatitis kan opleve en forværring af leversygdommen.
English: 400 single
Danish: 400 enkelt
English: Thereby, increasing the potential for sildenafilassociated adverse events (which include hypotension and syncope).
Danish: Derved stiger den potentielle risiko for sildenafil-associerede bivirkninger (som inkluderer hypotension og synkope).
English: − bupropion, a medicine used to help you stop smoking;
Danish: − bupropion, der er et lægemiddel, som anvendes til at hjælpe dig med at holde op med at ryge;
English: No human data on the effect of ritonavir on fertility are available.
Danish: Der foreligger ingen humandata om ritonavirs indvirkning på fertilitet.
English: For doses of exactly 100 mg amounts (100, 200, 300, 400, 500, or 600 mg) pour the entire content of each sachet over soft food (apple sauce or vanilla pudding) or mix with a small amount of liquid (water, chocolate milk, or infant formula) and consume entire serving.
Danish: For doser på præcis 100 mg (100, 200, 300, 400, 500, eller 600 mg) hældes hele indholdet af hvert brev på blød mad (æblemos eller vanille budding) eller, der blandes med en lille mængde væske (vand, kakaomælk eller modermælkerstatning), og hele portionen indtages.
English: Long term carcinogenicity studies of ritonavir in mice and rats revealed tumourigenic potential specific for these species, but are regarded as of no relevance for humans.
Danish: Langtids-karcinogenicitetsundersøgelser i mus og rotter viste et potentiale for tumorer specifik for disse dyrearter, men dette anses ikke for at være relevant for mennesker.
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Danish: Patienter med allerede eksisterende leverdysfunktion, herunder kronisk aktiv hepatitis, har en øget frekvens af leverfunktionsabnormiteter ved antiretroviral kombinationsbehandling og bør kontrolleres efter gældende praksis.
English: − rifabutin (used to prevent/treat certain infections)*;
Danish: − rifabutin (bruges til forebyggelse og behandling af visse infektioner)*;
English: Do not mix Norvir with anything else without talking to your doctor or pharmacist.
Danish: Bland ikke Norvir med noget andet uden først at tale med din læge eller apotekspersonalet.
English: Theophylline1
Danish: Theophyllin1
English: Modest prolongation of the PR interval was also noted in subjects receiving ritonavir in the same study on Day 3.
Danish: På dag 3 blev også set beskeden forlængelse af PR-intervallet hos individer, som fik ritonavir i det samme studie.
English: − buprenorphine, a medicine used for the treatment of chronic pain;
Danish: − buprenorphin, der er et lægemiddel, som anvendes til behandling af kroniske smerter;
English: Polyethylene/aluminium/polyethylene terephthalate foil sachet.
Danish: Polyetylen/aluminium/polyethylen-tereftalat folie brevet.
English: − You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: − Du kan stadig smitte andre med hiv, selvom du tager dette lægemiddel, selvom risikoen er nedsat ved effektiv antiretroviral terapi.
English: There is no specific antidote for overdose with ritonavir.
Danish: Der er ingen specifik modgift mod en overdosis af ritonavir.
English: Co-administration of saquinavir and ritonavir has led to severe adverse reactions, mainly diabetic ketoacidosis and liver disorders, especially in patients with pre-existing liver disease.
Danish: Samtidig indgift af saquinavir og ritonavir har ført til alvorlige bivirkninger, hovedsagelig diabetisk ketoacidose og leversygdomme, især hos patienter med en allerede eksisterende leversygdom.
English: If the benefit is considered to outweigh the risk and ritonavir must be used, patients should be carefully monitored for safety.
Danish: Hvis fordelen vurderes at opveje risikoen, og ritonavir skal anvendes, skal patienten sikkerhedsovervåges omhyggeligt.
English: Bupropion is primarily metabolised by CYP2B6.
Danish: Bupropion metaboliseres hovedsagelig af CYP2B6.
English: d. Tap the syringe again.
Danish: d. Bank på sprøjten igen.
English: Ritonavir adversely interacts with oral contraceptives (OCs).
Danish: Ritonavir giver alvorlige interaktioner med orale kontraceptiva (OK-er).
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); not known (cannot be estimated from the available data).
Danish: Inden for hver frekvensgruppe er bivirkningerne opstillet efter faldende alvorlighed: meget almindelig( ≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Film-coated tablet.
Danish: Filmovertruken tablet.
English: − cisapride (used to relieve certain stomach problems);
Danish: − cisaprid (bruges mod visse maveproblemer);
English: − People taking Norvir may still develop infections or other illnesses associated with HIV infection or AIDS.
Danish: − Personer, der tager Norvir, kan stadig udvikle infektioner eller andre sygdomme forbundet med hiv-infektion eller AIDS.
English: Plasma concentrations of ritonavir after administration of a single 100 mg dose tablet are similar to the 100 mg soft gelatin capsule under fed conditions.
Danish: Plasmakoncentrationen af ritonavir efter administration af en enkelt 100 mg tablet er den samme som efter en 100 mg blød gelatine kapsel efter fødeindtagelse.
English: Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection, as these patients have an increased risk of hepatotoxicity.
Danish: Der er grund til særlig bevågenhed ved patienter, der samtidig er inficeret med kronisk hepatitis B eller hepatitis C, da disse patienter har øget en risiko for hepatoksicitet.
English: If you stop taking Norvir
Danish: Hvis du holder op med at tage Norvir