FrancophonIA/ELRC3.0 huggingface dataset:
English: The percentage of patients with confirmed viral rebound >50 copies/ml during 48 weeks of follow-up was higher in the paediatric patients receiving lopinavir/ritonavir tablets once daily (12%) than in patients receiving the twice-daily dosing (8%, p = 0.19), mainly due to lower adherence in the once-daily group.
Danish: I løbet af 48 ugers opfølgning var andelen af patienter med bekræftet viral rebound > 50 kopier/ml, højere hos de pædiatriske patienter, som fik lopinavir/ritonavir tabletter én gang dagligt (12%), end hos de patienter, som fik dosering to gange dagligt (8 %, p = 0,19), hovedsagligt på grund af lavere komplians i en-gang-dagligt gruppen.
English: The EC50 of lopinavir against the 56 baseline viral isolates ranged from 0.6 to 96-fold higher than the EC50 against wild type HIV.
Danish: EC50 af lopinavir mod de 56 virale isolater ved baseline var fra 0,6 til 96 gange højere end EC50 mod vildtype hiv.
English: The active substances are lopinavir and ritonavir.
Danish: Aktive stoffer: lopinavir og ritonavir.
English: Concomitant use of avanafil or vardenafil and lopinavir/ritonavir is contraindicated (see section 4.3).
Danish: Samtidig brug af avanafil eller vardenafil og lopinavir/ritonavir er kontraindiceret (se pkt.
English: Since increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis, the combination of these agents with Kaletra is contraindicated (see section 4.3).
Danish: Da øgede koncentrationer af HMG-CoA-reduktase-hæmmere kan forårsage myopati, inklusive rhabdomyolyse, er kombinationen af disse stoffer med Kaletra kontraindiceret (se pkt.
English: The following table contains dosing guidelines for Kaletra 100/25 mg tablets based on BSA when used in combination with efavirenz or nevirapine in children.
Danish: Følgende tabel indeholder doseringsvejledning for Kaletra 100/25 mg tabletter baseret på BSA, når det anvendes til børn i kombination med efavirenz eller nevirapin.
English: Higher tenofovir concentrations could potentiate tenofovir associated adverse events, including renal disorders.
Danish: Højere tenofovir-koncentrationer kan forstærke tenofovir-associerede bivirkninger, herunder nyrelidelser.
English: Fusidic acid used to treat long-term infections of the bones and joints may be taken under doctor's supervision (see Other medicines and Kaletra section);
Danish: Fusidinsyre brugt til behandling af langvarige infektioner i knogler og led kan tages med rådgivning fra lægen (se Brug af anden medicin sammen med Kaletra);
English: • Kaletra tablets can be taken with or without food.
Danish: • Kaletra-tabletter kan tages sammen med eller uden mad.
English: Hypersensitivity to the active substances or to any of the excipients.
Danish: Allergi over for de aktive indholdsstoffer og over for eller ét eller flere af hjælpestofferne.
English: Resistance to lopinavir, defined as the presence of any primary or active site mutations in protease (see above), was observed in 0/51 (0%) patients.
Danish: Resistens overfor lopinavir, defineret som tilstedeværelse af enhver primær eller mutation i det aktive site i protease (se ovenfor), blev observeret hos 0/51 (0%) patienter.
English: Postmarketing life-threatening cases of cardiac toxicity (including complete atrioventricular (AV) block, bradycardia, and cardiomyopathy), lactic acidosis, acute renal failure, CNS depression and respiratory complications leading to death have been reported, predominantly in preterm neonates receiving Kaletra oral solution (see sections 4.3 and 4.9).
Danish: Der er postmarketing rapporteret om livstruende tilfælde af kardiotoksicitet (inklusive komplet atrioventrikulært (AV) blok, bradykardi og kardiomyopati), laktatacidose, akut nyresvigt, CNS-depression og respirationskomplikationer med døden til følge, hovedsageligt hos præmature nyfødte, som fik Kaletra oral opløsning (se pkt.
English: The median fold IC50 of lopinavir for these 18 isolates at baseline and rebound was 6.9- and 63-fold, respectively, compared to wild type virus.
Danish: Den gennemsnitlige sammenlægning af IC50 for lopinavir for disse 18 isolater ved baseline og rebound var henholdsvis 6,9- og 63-gange sammenlignet med vildtype-virus.
English: • quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder);
Danish: • quetiapin (bruges til behandling af skizofreni, bipolær lidelse (manio-depressiv lidelse) og depression);
English: Marketing Authorisation Holder:
Danish: Indehaveren af markedsføringstilladelsen:
English: Adultc a. Kaletra oral solution 230/57.5 mg/m2 twice daily regimen without nevirapine b. Kaletra oral solution 300/75 mg/m2 twice daily regimen with nevirapine c. Kaletra film-coated tablets 400/100 mg twice daily at steady state
Danish: Voksnec a. Kaletra oral opløsning 230/57,5 mg/m2 to gange dagligt uden nevirapin b. Kaletra oral opløsning 300/75 mg/m2 to gange dagligt med nevirapin c. Kaletra filmovertrukne tabletter 400/100 mg to gange dagligt ved steady-state
English: Important to open
Danish: Åbnes her
English: or
Danish: eller
English: Gastrointestinal disorders
Danish: Gastrointestinal motilitetsmiddel
English: Aesica Queenborough Ltd, Queenborough, Kent ME11 5EL, United Kingdom AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, The Netherlands AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Danish: Aesica Queenborough Ltd, Queenborough, Kent ME11 5EL, Storbritannien AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, Holland AbbVie Deutschland GmbH & Co.
English: When co-administered with carbamazepine or phenobarbital, an increase of Kaletra dosage may be envisaged.
Danish: Ved samtidig administration med carbamazepin eller phenobarbital, må en øgning af Kaletra-dosis overvejes.
English: • lomitapide (used to lower blood cholesterol);
Danish: • lomitapid (bruges til at sænke kolesterol i blodet);
English: Concentrations may be affected when co-administered with lopinavir/ritonavir due to CYP2C9 induction.
Danish: Koncentrationerne kan påvirkes ved samtidig administration med lopinavir/ritonavir på grund af CYP2C9-induktion.
English: Children were eligible when they were aged <18 years, ≥15 kg in weight, receiving cART that included lopinavir/ritonavir, HIV-1 ribonucleic acid (RNA) <50 copies/ml for at least 24 weeks and able to swallow tablets.
Danish: Børnene kunne inkluderes, når de var <18 år, vejede > 15 kg, fik cART, der omfattede lopinavir/ritonavir, havde hiv-1-ribonukleinsyre (RNA) < 50 kopier/ml i mindst 24 uger og var i stand til at synke tabletter.
English: Consequently, concomitant administration of Kaletra and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Danish: Som konsekvens heraf anbefales samtidig administration af Kaletra og disse glukokortikoider ikke, medmindre de potentielle fordele ved behandlingen opvejer risikoen for systemiske virkninger af kortikosteroid (se pkt.
English: Mean increase from baseline in CD4+ T-cell count (cells/mm3) * intent to treat analysis where patients with missing values are considered virologic failures
Danish: Gennemsnitlig stigning i CD4+ T-celletal (celler/mm3) fra baseline * intent-to-treat-analyse, hvor patienter med manglende værdier anses for at have virologisk svigt
English: Cases of pancreatitis have been reported in patients receiving Kaletra, including those who developed hypertriglyceridaemia.
Danish: Tilfælde af pankreatitis er blevet rapporteret hos patienter i behandling med Kaletra, deriblandt patienter, der udviklede hypertriglyceridæmi.
English: The treatment regimen was zidovudine plus lamivudine plus 300 mg lopinavir/75 mg ritonavir per m2 twice daily until 6 months of age, then 230 mg lopinavir/57.5 mg ritonavir per m2 twice daily.
Danish: Behandlingsregimet var zidovudin plus lamivudin plus 300 mg lopinavir/75 mg ritonavir pr. m2 to gange dagligt indtil en alder på 6 måneder, derefter 230 mg lopinavir/57,5 mg ritonavir pr. m2 to gange dagligt.
English: Refer to the ceritinib SmPC for dosage adjustment recommendations.
Danish: Se produktresuméet for ceritinib vedrørende anbefalinger for dosisjustering.
English: Kaletra 100 mg/25 mg film-coated tablets are supplied in plastic bottles containing 60 tablets.
Danish: Kaletra 100 mg/25 mg filmovertrukne tabletter findes i en plastik beholder, som indeholder 60 tabletter.
English: 40 film-coated tablets.
Danish: 40 filmovertrukne tabletter.
English: In addition, co-administration of apalutamide and Kaletra may lead to serious adverse events including seizure due to higher apalutamide levels.
Danish: Derudover kan samtidig administration af apalutamid og Kaletra føre til alvorlige bivirkninger inklusive krampeanfald på grund af højere niveauer af apalutamid.
English: Carbamazepine:
Danish: Carbamazepin:
English: When used for osteo-articular infections, where the coadministration is unavoidable, close clinical monitoring for muscular adverse events is strongly recommended (see section
Danish: Hvis samtidig administration er uundgåelig ved osteo-artikulære infektioner, anbefales tæt klinisk overvågning for muskulære bivirkninger kraftigt (se pkt.
English: Blisters packs - polyvinyl chloride (PVC) blisters with fluoropolymer foil backing Two pack sizes are available: - carton containing 120 film-coated tablets - multipack containing 120 (3 cartons of 40) film-coated tablets
Danish: Blisterpakninger - Polyvinylchlorid (PVC)-blister med fluoropolymer-folie bagside To pakningsstørrelser er tilgængelige: Karton, som indeholder 120 filmovertrukne tabletter Multipakning som indeholder 120 (3 beholdere á 40) filmovertrukne tabletter.
English: • levothyroxine (used to treat thyroid problems);
Danish: • levothyroxin (bruges til at behandle problemer med skjoldbruskkirtlen);
English: Increased risk of alanine transaminase (ALT) elevations (see section 4.5).
Danish: Øget risiko for alanintransaminase (ALT) forhøjelser (se pkt.
English: Large decreases in lopinavir concentrations may be observed due to CYP3A induction by rifampicin.
Danish: Store fald i lopinavirkoncentrationerne kan observeres på grund af CYP3A-induktion af rifampicin.
English: The lopinavir mean steadystate AUC, Cmax, and Cmin were 72.6 ± 31.1 µg•h/ml, 8.2 ± 2.9 µg/ml and 3.4 ± 2.1 µg/ml, respectively after Kaletra oral solution 230/57.5 mg/m2 twice daily without nevirapine (n=12), and were 85.8 ± 36.9 µg•h/ml, 10.0 ± 3.3 µg/ml and 3.6 ± 3.5 µg/ml, respectively after 300/75 mg/m2 twice daily with nevirapine (n=12).
Danish: Lopinavir gennemsnitlig steady-state AUC, Cmax og Cmin var henholdsvis 72,6 ± 31,1 µg•h/ml, 8,2 ± 2,9 µg/ml og 3,4 ± 2,1 µg/ml efter Kaletra 230/57,5 mg/m2 to gange dagligt uden nevirapin (n=12) og var henholdsvis 85,8 ± 36,9 µg•h/ml, 10,0 ± 3,3 µg/ml og 3,6 ± 3,5 µg/ml efter 300/75 mg/m2 to gange dagligt med nevirapin (n=12).
English: Particular caution must be used when prescribing sildenafil or tadalafil in patients receiving Kaletra with increased monitoring for adverse events including hypotension, syncope, visual changes and prolonged erection (see section 4.4).
Danish: Der må udvises særlig forsigtighed, når sildenafil eller tadalafil ordineres til patienter, som får Kaletra med øget overvågning af bivirkninger inklusive hypotension, synkope, synsændringer og forlænget erektion (se pkt.
English: Lower respiratory tract infection, skin infections including cellulitis, folliculitis and furuncle
Danish: Nedre luftvejsinfektioner, hudinfektioner inklusive cellulit, follikulit og furunkler
English: They were randomised in a 1:1 ratio to receive either lopinavir/ritonavir 800/200 mg once daily (n = 300) or lopinavir/ritonavir 400/100 mg twice daily (n = 299).
Danish: De blev randomiseret i forholdet 1:1 til at få enten lopinavir/ritonavir 800/200 mg en gang dagligt (n = 300) eller lopinavir/ritonavir 400/100 mg to gange dagligt (n = 299).
English: At entry, median age was 0.7 years, median CD4 T-cell count was 1147 cells/mm3, median CD4 T-cell was 19%, and median HIV-1 RNA was > 750,000 copies/ml.
Danish: Ved start var den mediane alder 0,7 år, median CD4 Tcelletal var 1147 celler/mm3, median CD4% T-celle var 19% og median hiv-1 RNA var > 750.000 kopier/ml.
English: Polyvinyl alcohol, talc, titanium dioxide, macrogols type 3350, yellow ferric oxide E172.
Danish: Polyvinylalkohol, talkum, titandioxid, macrogoler type 3350 og gul jernoxid E172.
English: • vertigo (spinning feeling);
Danish: • svimmelhed (følelse af rotation);
English: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany Fournier Laboratories Ireland Limited, Carrigtwohill Business Park, Anngrove, Carrigtwohill, Co. Cork, Ireland
Danish: KG, Knollstrasse, 67061 Ludwigshafen, Tyskland Fournier Laboratories Ireland Limited, Carrigtwohill Business Park, Anngrove, Carrigtwohill, Co. Cork, Irland
English: • Kaletra is not a cure for HIV infection or AIDS.
Danish: • Kaletra helbreder ikke hiv-infektion eller AIDS.
English: The inducing effect may persist for at least 2 weeks after cessation of treatment with St John's wort (see section 4.3).
Danish: Den inducerende effekt kan vare ved i mindst 2 uger efter ophør med behandling med perikon (se pkt.
English: to < 1/10), uncommon (≥ 1/1000 to < 1/100) and not known (cannot be estimated from the available data).
Danish: De alvorligste er anført først: meget almindelig (≥ 1/10), almindelig ((≥ 1/100 til < 1/10), ikke almindelig (≥1/1000 til< 1/100) og ikke kendt (kan ikke estimeres ud fra de forhåndenværende data).
English: Kaletra contains 42% v/v alcohol and 15% propylene glycol w/v. Each 1 ml of Kaletra oral solution contains 356.3 mg of alcohol and 152.7 mg of propylene glycol.
Danish: Kaletra indeholder 42 % v/v alkohol og 15 % propylenglykol w/v. 1 ml Kaletra oral opløsning indeholder 356,3 mg alkohol og 152,7 mg propylenglykol.
English: Clinical monitoring of antiviral efficacy is recommended when these medicines are concomitantly administered with Kaletra.
Danish: Klinisk overvågning af terapeutisk effekt anbefales, når disse lægemidler administreres samtidig med Kaletra.
English: • medicines affecting the immune system (e.g. cyclosporin, sirolimus (rapamycin), tacrolimus);
Danish: • lægemidler, som påvirker immunsystemet (f.eks. ciclosporin, sirolimus (rapamycin),
English: AUC: ↑ 5.9-fold
Danish: AUC: ↑ 5,9-gange
English: Phosphodiesterase(PDE5) inhibitors Avanafil (ritonavir 600 mg BID)
Danish: Phosphordiesterase-5 (PDE5)-hæmmere Avanafil (ritonavir 600 mg to gange dagligt)
English: Increased risk of side-effects (respiratory depression, sedation) due to higher plasma concentrations because of CYP3A4 inhibition by lopinavir/ritonavir.
Danish: Forøget risiko for bivirkninger (respirationsdepression, sedation) på grund af højere plasmakoncentrationer, som skyldes lopinavir/ritonavirs hæmning af CYP3A4.
English: Caution should be exercised and reduced doses should be considered when Kaletra is co-administered with rosuvastatin (see section 4.4).
Danish: Der bør udvises forsigtighed og nedsat dosis bør overvejes, når Kaletra administreres sammen med rosuvastatin (se pkt.
English: QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 39 healthy adults, with 10 measurements over 12 hours on Day 3.
Danish: QTcF-intervallet blev evalueret i et randomiseret, placebo og aktiv (moxifloxacin 400 mg en gang dagligt) kontrolleret overkrydsningsstudier hos 39 raske voksne, med 10 målinger over 12 timer på dag 3.
English: Concomitant use of Kaletra with rilpivirine causes an increase in the plasma concentrations of rilpivirine, but no dose adjustment is required.
Danish: Samtidig administration af Kaletra og rilpivirin øger rilpivirin-plasmakoncentrationen, men dosisjustering er ikke nødvendig.
English: • Kaletra is used by children 2 years of age or older, adolescents and adults who are infected with HIV, the virus which causes AIDS.
Danish: • Kaletra kan anvendes af børn fra 2 år, unge og voksne, der er smittet med hiv, som er den virus, der forårsager aids.
English: • antiviral medicine used to treat chronic hepatitis C virus (HCV) infection in adults (e.g. glecaprevir/pibrentasvir, simeprevir and sofosbuvir/velpatasvir/voxilaprevir);
Danish: • antivirale midler, som bruges til at behandle kronisk hepatitis C-virusinfektion hos voksne (f.eks. glecaprevir/pibrentasvir, simeprevir og sofosbuvir/velpatasvir/voxilaprevir);
English: Method of administration
Danish: Samtidig administration
English: Most tyrosine kinase inhibitors such as dasatinib and nilotinib, also vincristine and vinblastine: Risk of increased adverse events due to higher serum concentrations because of CYP3A4 inhibition by lopinavir/ritonavir.
Danish: De fleste tyrosinkinasehæmmere sådan som dasatinib og nilotinib, også vincristin, vinblastin: Risiko for flere bivirkninger på grund af højere serumkoncentrationer på grund af lopinavir/ritonavirs hæmning af CYP3A4.
English: Increased plasma concentrations of astemizole and terfenadine.
Danish: Forhøjede plasmakoncentrationer af astemizol og terfenadin.
English: Therefore, Kaletra tablets may be taken with or without food.
Danish: Derfor kan Kaletra tabletter tages med eller uden mad.
English: After removing the air bubbles, look at the dose mark.
Danish: Check dosismarkeringen, efter du har fjernet luftbobler.
English: Steady-state concentrations was moderately decreased due to CYP2C9 and CYP2C19 induction by lopinavir/ritonavir.
Danish: Steady-state-koncentrationerne faldt moderat på grund af CYP2C9- og CYP2C19induktion af lopinavir/ritonavir.
English: Antihistamines Astemizole Terfenadine
Danish: Antihistaminer Astemizol Terfenadin
English: Life-threatening and fatal drug interactions have been reported in patients treated with colchicine and strong inhibitors of CYP3A like ritonavir.
Danish: Der er rapporteret om livstruende og dødelige lægemiddelinteraktioner hos patienter behandlet med colchicin og potente CYP3A-hæmmere som ritonavir.
English: Outcomes at Week 48: Study M98-957
Danish: Resultater ved uge 48: Studie M98-957
English: The pharmacokinetics of Kaletra 100/25 mg tablet twice-daily weight-band dosing without nevirapine have been studied in a total of 53 paediatric patients.
Danish: Farmakokinetikken af Kaletra 100/25 mg tablet to gange dagligt baseret på vægt uden nevirapin er undersøgt hos i alt 53 pædiatriske patienter.
English: Ritonavir inhibits the metabolism of lopinavir, thereby increasing the plasma levels of lopinavir.
Danish: Ritonavir hæmmer metabolismen af lopinavir og øger derved plasmaniveauet af lopinavir.
English: The following table contains dosing guidelines for Kaletra 100/25 mg tablets based on body weight and BSA.
Danish: Følgende tabel indeholder doseringsvejledninger for Kaletra 100 mg/25 mg baseret på legemsvægt og BSA.
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Danish: BILAG I PRODUKTRESUMÈ
English: Kaletra contains polyoxyl 40 hydrogenated castor oil.
Danish: Kaletra indeholder polyxol 40 ricinusolie.
English: • If the dose is between 2 ml and 5 ml - use the 5 ml oral dosing syringe to prepare a dose.
Danish: • Hvis dosis er mellem 2 ml og 5 ml - brug den orale doseringssprøjte på 5 ml til at klargøre dosen.
English: Refer to the Summary of Product Characteristics for Kaletra oral solution for dosing instructions.
Danish: Se produktresuméet for Kaletra oral opløsning for doseringsvejledning.
English: • Kaletra is used by children 14 days of age and older, adolescents and adults who are infected with HIV, the virus which causes AIDS.
Danish: • Kaletra kan anvendes af børn fra 14 dage og ældre, unge og voksne, der er smittet med hiv, som er den virus, der forårsager aids.
English: Rare reports of 2nd or 3rd degree atroventricular block in patients with underlying structural heart disease and pre-existing conduction system abnormalities or in patients receiving drugs known to prolong the PR interval (such as verapamil or atazanavir) have been reported in patients receiving lopinavir/ritonavir.
Danish: Hos patienter, der får lopinavir/ritonavir, er der rapporteret om sjældne tilfælde af 2. eller 3. grads atroventrikulær blok hos patienter med underliggende strukturel hjertesygdom og eksisterende overledningsforstyrrelser eller hos patienter, der får lægemidler, der er kendt for at forlænge PR-intervallet (sådan som verapamil eller atazanavir).
English: The combination of Kaletra with: - tadalafil, indicated for the treatment of pulmonary arterial hypertension, is not recommended
Danish: Kombination af Kaletra med: tadalafil til behandling af pulmonal arteriel hypertension anbefales ikke (se pkt.
English: Kaletra tablets can be taken with or without food.
Danish: Kaletra-tabletter kan tages sammen med eller uden mad.
English: Caution should be exercised in administering clarithromycin with Kaletra to patients with impaired hepatic or renal function.
Danish: Der bør udvises forsigtighed ved administration af clarithromycin med Kaletra til patienter med nedsat lever- eller nyrefunktion.
English: Total amounts of alcohol and propylene glycol from all medicines, including Kaletra oral solution, that are to be given to infants should be taken into account in order to avoid toxicity from these excipients (see section 4.4).
Danish: Der bør tages hensyn til den totale mængde ethanol og propylenglycol fra alle lægemidler, inklusive Kaletra oral opløsning som gives til spædbarnet, for at undgå toksicitet fra disse hjælpestoffer (se pkt
English: The lopinavir mean ± standard deviation steady-state AUC, Cmax and C12 were 112.5 ± 37.1 μg•h/ml, 12.4 ± 3.5 μg/ml and 5.71 ± 2.99 μg/ml, respectively.
Danish: Lopinavirs gennemsnitlige + standardafvigelse for AUC, Cmax og C12 ved steady-state var henholdsvis 112,5 + 37,1 µg∙time/ml, 12,4 + 3,5 µg/ml og 5,71 + 2,99 µg/ml.
English: Carbamazepine and phenobarbital levels should be monitored when co-administering with Kaletra.
Danish: Carbamazepin- og phenobarbitalniveauerne bør overvåges ved samtidig administration med Kaletra.
English: • antifungals (e.g. ketoconazole, itraconazole, voriconazole);
Danish: • lægemidler mod svamp (f.eks. ketoconazol, itraconazol, voriconazol);
English: In addition to the mutations described above, mutations V32I and I47A have been observed in rebound isolates with reduced lopinavir susceptibility from protease inhibitor experienced patients receiving Kaletra therapy, and mutations I47A and L76V have been observed in rebound isolates with reduced lopinavir susceptibility from patients receiving Kaletra therapy.
Danish: I tillæg til mutationerne beskrevet ovenfor, er mutation V32I og I47A blevet observeret i rebound-isolater med nedsat lopinavir-følsomhed hos proteasehæmmer-erfarne-patienter, som fik Kaletra-behandling, og mutation I47A og L76V er blevet observeret i rebound-isolater med nedsat lopinavir-følsomhed hos proteasehæmmer-erfarne-patienter, som fik Kaletra-behandling
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Danish: Patienter med kronisk hepatitis B eller C, som har fået antiretroviral kombinationsbehandling, har øget risiko for at få alvorlige bivirkninger og potientielt dødelige leverreaktioner.
English: Kaletra should be used with caution in such patients (see section 5.1).
Danish: Kaletra bør bruges med forsigtighed til sådanne patienter (se pkt.
English: The choice of Kaletra to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients (see sections 4.4 and 5.1).
Danish: Valget af Kaletra til behandling af hiv-1-patienter, der allerede er blevet behandlet med proteasehæmmere, skal baseres på test af individuel viral resistens og patientens anamnese (se pkt.
English: Outcomes at Week 360: Study M97-720
Danish: Resultater ved uge 360: Studie M97-720
English: Blood glucose disorders including diabetes mellitus, hypertriglyceridaemia, hypercholesterolemia, weight decreased, decreased appetite
Danish: Blodglucoseforstyrrelselser inklusive diabetes mellitus, hypertriglyceridæmi, hyperkolesterolæmi, vægttab, nedsat appetit