FrancophonIA/ELRC3.0 huggingface dataset:
English: KONCERT/PENTA 18 is a prospective multicentre, randomised, open-label study that evaluated the pharmacokinetic profile, efficacy and safety of twice-daily versus once-daily dosing of lopinavir/ritonavir 100 mg/25 mg tablets dosed by weight as part of combination antiretroviral therapy (cART) in virologically suppressed HIV-1 infected children (n=173).
Danish: KONCERT/PENTA18 er et prospektivt, randomiseret, åbent, multicenter studie, som evaluerede farmakokinetisk profil, virkning og sikkerhed af vægtbaseret dosering af lopinavir/ritonavir100 mg/25 mg tabletter to gange dagligt versus en gang dagligt som en del af antiretroviral kombinationsbehandling (CART) hos virologisk supprimerede hiv-1-inficerede børn (n=173).
English: Lopinavir/ritonavir plasma concentrations may decrease due to CYP3A4 induction by bosentan.
Danish: Lopinavir/ritonavirs plasmakoncentrationer kan falde på grund af bosentans induktion af CYP3A4.
English: Co-administration of rivaroxaban and Kaletra may increase rivaroxaban exposure which may increase the risk of bleeding.
Danish: Samtidig administration af rivaroxaban og Kaletra kan øge rivaroxaban-eksponeringen, hvilket kan øge risikoen for blødning.
English: Rifampicin in combination with Kaletra causes large decreases in lopinavir concentrations which may in turn significantly decrease the lopinavir therapeutic effect.
Danish: Rifampicin i kombination med Kaletra forårsager stor reduktion i lopinavir-koncentrationer, hvilket kan resultere i et signifikant fald i lopinavirs terapeutiske effekt.
English: Quetiapine
Danish: Quetiapin
English: Read the list of medicines below under ‘Other medicines and Kaletra' for information on certain other medicines which require special care.
Danish: Se listen med lægemidler nedenfor, under ‘Brug af anden medicin sammen med Kaletra' for at få oplysninger om visse andre lægemidler, som kræver, at der udvises særlig forsigtighed.
English: Antihistamines
Danish: Antihistaminer
English: The recommended dosage of Kaletra is 5 ml of oral solution (400/100 mg) twice daily taken with food.
Danish: Den anbefalede dosis af Kaletra er 5 ml oral opløsning (400/100 mg) to gange dagligt i forbindelse med et måltid.
English: • You must not take Kaletra with sildenafil used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery) (see also Do not take Kaletra section above).
Danish: • Du må ikke tage Kaletra, hvis du tager sildenafil for at behandle unormalt forhøjet blodtryk i lungernes blodkar (pulmonal arteriel hypertension) (se også punktet Tag ikke Kaletra ovenfor).
English: Each 1 ml of Kaletra oral solution contains 356.3 mg of alcohol and 152.7 mg of propylene glycol.
Danish: 1 ml Kaletra oral opløsning indeholder 356,3 mg ethanol og 152,7 mg propylenglycol.
English: • inability to control your bowels;
Danish: • manglende evne til at kontrollere afføring;
English: Pancreatitis1, vomiting, gastrooesophageal reflux disease, gastroenteritis and colitis, abdominal pain (upper and lower), abdominal distension, dyspepsia, haemorrhoids, flatulence
Danish: Pankreatit1, opkastning, gastroøsofageal reflukssygdom, gastroenterit og colitis, mavesmerter (øvre og nedre), abdominal distension, dyspepsi, hæmorider, flatulens
English: Erectile dysfunction, menstrual disordersamenorrhoea, menorrhagia
Danish: Erektil dysfunktion, menstruationsforstyrrelser -amenoré, menoragi
English: Administration of a single 400/100 mg dose of Kaletra soft capsules with a moderate fat meal (500 - 682 kcal, 22.7 -25.1% from fat) was associated with a mean increase of 48% and 23% in lopinavir AUC and Cmax, respectively, relative to fasting.
Danish: Indtag af en enkelt 400/100 mg dosis af Kaletra bløde kapsler og et måltid med moderat fedtindhold (500 - 682 kcal, 22,7-25,1 % fra fedt) var forbundet med en gennemsnitlig stigning på 48 % og 23 % for henholdsvis lopinavir AUC og Cmax i forhold til fastende betingelser.
English: How should I dispose of any unused Kaletra?
Danish: Sådan bortskaffer du ubrugt Kaletra
English: Colchicine
Danish: Colchicin
English: These increases of plasma concentrations of co-administered medicinal products could increase or prolong their therapeutic effect and adverse events (see sections 4.3 and
Danish: Disse stigninger i plasmakoncentrationer af lægemidler, der anvendes samtidig med Kaletra, kan øge eller forlænge deres terapeutiske virkninger og bivirkninger (se pkt.
English: Contents of the pack and other information What Kaletra contains
Danish: Pakningsstørrelser og yderligere oplysninger Kaletra indeholder
English: The adult dose of Kaletra tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m2. Kaletra tablets are administered orally and must be swallowed whole and not chewed, broken or crushed.
Danish: Voksendosis af Kaletra-tabletter (400/100 mg to gange dagligt) kan bruges til børn, som vejer 40 kg eller mere eller har et legemsoverfladeareal (BSA)* større end 1,4 m2. Kaletra-tabletter indgives oralt, skal synkes hele og ikke tygges, brækkes eller knuses.
English: When co-administered with phenytoin, an increase of Kaletra dosage may be envisaged.
Danish: Ved samtidig administration med phenytoin, må en øgning af Kaletradosis overvejes.
English: Caution should be exercised in administering carbamazepine or phenobarbital with Kaletra.
Danish: Der bør udvises forsigtighed ved samtidig administration af carbamazepin eller phenobarbital med Kaletra.
English: A dose adjustment of Kaletra 400 mg/400 mg (i.e. Kaletra 400/100 mg + ritonavir 300 mg) twice daily has allowed compensating for the CYP 3A4 inducer effect of rifampicin.
Danish: En dosisjustering af Kaletra 400 mg/400 mg (dvs. Kaletra 400/100 mg + ritonavir 300 mg) to gange dagligt har gjort det muligt at kompensere for rifampicins CYP 3A4-inducerende effekt.
English: Study M05-730 was a randomised, open-label, multicentre trial comparing treatment with Kaletra 800/200 mg once daily plus tenofovir DF and emtricitabine versus Kaletra 400/100 mg twice daily plus tenofovir DF and emtricitabine in 664 antiretroviral treatment-naïve patients.
Danish: Studie M05-730 var et randomiseret, åbent, multicenter studie, som sammenlignede behandling med Kaletra 800/200 mg en gang dagligt plus tenofovir DF og emtricitabin mod Kaletra 400/100 mg to gange dagligt plus tenofovir DF og emtricitabin hos 664 antiretroviral-behandlingsnaive patienter.
English: The standard recommended dosage of Kaletra tablets is 400/100 mg (two 200/50 mg) tablets twice daily taken with or without food.
Danish: Den anbefalede standarddosis af Kaletra-tabletter er 400/100 mg (to 200/50 mg) tabletter to gange dagligt taget med eller uden føde.
English: • inflammation of the liver including increased liver enzymes;
Danish: • leverbetændelse inklusive forhøjede leverenzymer;
English: Increased plasma concentrations of paritaprevir; thereby, increasing the risk of alanine transaminase (ALT) elevations (see section 4.5).
Danish: Forhøjede plasmakoncentrationer af paritaprevir; derved øges risikoen for alanintransaminase (ALT) forhøjelser (se pkt.
English: Smoking cessation aids Bupropion
Danish: Midler til rygeophør Bupropion
English: Across studies, administration of Kaletra 400/100 mg twice daily yields mean steady-state lopinavir plasma concentrations 15 to 20-fold higher than those of ritonavir in HIV-infected patients.
Danish: I forskellige afprøvninger af hiv-smittede patienter ses det, at Kaletra 400/100 mg to gange dagligt forårsager gennemsnitlige steady-state lopinavir plasmakoncentrationer, der er 15 til 20 gange højere end ritonavir.
English: Recommended lopinavir/ritonavir dosing (mg) twice daily.
Danish: Anbefalet lopinavir/ritonavir dosis (mg) 2 gange dagligt.
English: • alfuzosin (used in men to treat symptoms of an enlarged prostate (benign prostatic hyperplasia (BPH));
Danish: • alfuzosin (bruges til at behandle symptomer på forstørret blærehalskirtel hos mænd (godartet prostatahyperplasi);
English: Oral solution contains: alcohol (42.4% v/v), high fructose corn syrup, propylene glycol (15.3% w/v), purified water, glycerol, povidone, magnasweet-110 flavour (mixture of monoammonium glycyrrhizinate and glycerol),
Danish: Oral opløsning indeholder: ethanol (42, 4 % v/v), majssirup (højt fructoseindhold), propylenglycol (15.3% w/v), renset vand, glycerol, povidon, magnasweet-110 aroma (blanding af monoammonium glycyrrhizinat og glycerol),
English: Etravirine:
Danish: Etravirin :
English: When given with Kaletra the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example Monday-WednesdayFriday).
Danish: Ved administration sammen med Kaletra er den anbefalede rifabutin-dosis 150 mg 3 gange om ugen på fastsatte dage (for eksempel mandag-onsdagfredag).
English: • steroids (e.g. budesonide, dexamethasone, fluticasone propionate, ethinyl oestradiol,
Danish: • steroider (f.eks. budesonid, dexamethason, fluticasonpropionat, ethinylestradiol, triamcinolon).
English: Administration of a single 400/100 mg dose of Kaletra tablets under fed conditions (high fat, 872 kcal, 56% from fat) compared to fasted state was associated with no significant changes in Cmax and AUCinf.
Danish: Administration af en enkelt 400/100 mg dosis af Kaletra tabletter og et måltid med højt fedtindhold (872 kcal, 56 % fra fedt) medførte ingen signifikante ændringer i Cmax og AUCinf sammenlignet med fastende betingelser.
English: Increased plasma concentrations of venetoclax.
Danish: Øgede plasmakoncentrationer af venetoclax.
English: • protease inhibitors (e.g. fosamprenavir, indinavir, ritonavir, saquinavir, tipranavir);
Danish: • proteasehæmmere (f.eks. fosamprenavir, indinavir, ritonavir, saquinavir, tipranavir);
English: • medicines used to treat asthma and other lung-related problems such as chronic obstructive pulmonary disease (COPD) (e.g. salmeterol);
Danish: • lægemidler mod astma og andre lungesygdomme såsom kronisk obstruktiv lungesygdom (KOL)
English: Lopinavir/ritonavir has been shown to cause modest asymptomatic prolongation of the PR interval in some healthy adult subjects.
Danish: Hos nogle raske voksne individer har lopinavir/ritonavir vist sig at forårsage beskeden asymptomatisk forlængelse af PR-intervallet.
English: Kaletra must not be administered once daily in combination with carbamazepine and phenobarbital.
Danish: Kaletra må ikke indgives en gang dagligt i kombination med carbamazepin og phenobarbital.
English: Body weight (kg) Twice daily oral solution dose (dose in mg/kg)
Danish: Dosis oral opløsning to gange dagligt (dosis i mg/kg)
English: For children 14 days and older and weighing up to 15 kg
Danish: Til børn på 14 dage og ældre der vejer op til 15 kg
English: HIV RNA < 400 copies/ml* Median change from baseline in CD4+ T-cell count (cells/mm3)
Danish: hiv RNA < 400 kopier/ml* Median ændring fra baseline i CD4+ T-celle tal (celler/mm3)
English: Trazodone: AUC: ↑ 2.4-fold
Danish: Trazodon: AUC: ↑ 2,4-gange
English: A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with Kaletra is required.
Danish: Hvis behandling med Kaletra er nødvendig, anbefales det, at colchicin-dosis nedsættes eller behandlling med colchicin afbrydes hos patienter med normal nyre- eller leverfunktion.
English: The selection of resistance to lopinavir in patients having failed prior protease inhibitor therapy was characterised by analysing the longitudinal isolates from 19 protease inhibitor-experienced subjects in 2 Phase II and one Phase III studies who either experienced incomplete virologic suppression or viral rebound subsequent to initial response to Kaletra and who demonstrated incremental in vitro resistance between baseline and rebound (defined as emergence of new mutations or 2-fold change in phenotypic susceptibility to lopinavir).
Danish: Bedømmelse af resistens mod lopinavir hos patienter, hvor tidligere behandling med proteasehæmmere var mislykkedes, var karakteriseret ved analyse af isolater fra længderetningen fra 19 proteasehæmmer-erfarne forsøgspersoner i 2 fase II- og et fase III-studier, som enten oplevede ufuldstændig virologisk undertrykkelse eller viral rebound efter initial respons på Kaletra, og som udviste trinvis voksende in-vitro-resistens mellem baseline og rebound (defineret som tilsynekomst af nye mutationer eller 2-gange ændring i fænotype-følsomhed for lopinavir).
English: Macrogols type 3350 (Polyethylene glycol 3350) Yellow ferric oxide E172
Danish: Macrogoler type 3350 (polyethylenglycol 3350) Gul jernoxid E172
English: Co-administration of ibrutinib and Kaletra should be avoided.
Danish: Samtidig administration af ibrutinib og Kaletra bør undgås.
English: Concomitant use of Kaletra with lomitapide is contraindicated (see prescribing information for lomitapide) (see section 4.3).
Danish: Samtidig brug af Kaletra med lomitapid er kontraindiceret (se produktresuméet for lomitapid) (se pkt.4.3).
English: Package leaflet: Information for the user Kaletra (80 mg + 20 mg) / ml oral solution
Danish: Indlægsseddel: Information til brugeren Kaletra (80 mg + 20 mg) / ml oral opløsning
English: It is not recommended to co-administer Kaletra and sofosbuvir/velpatasvir/ voxilaprevir.
Danish: Samtidig administration af Kaletra og sofosbuvir/velpatasvir/ voxilaprevir anbefales ikke.
English: Outcomes at Week 48: Study M98-940* Antiretroviral Naïve (N=44)
Danish: Resultater ved uge 48: Studie M98-940* Antiretroviral naive (N=44)
English: An oral solution is available to patients who have difficulty swallowing.
Danish: Der findes en oral opløsning for patienter, der har svært ved at sluge tabletter.
English: • morphine-like medicines (e.g. methadone);
Danish: • morfinlignende lægemidler (f.eks. methadon);
English: In an open-label pharmacokinetic study, 12 HIV-infected pregnant women who were less than 20 weeks of gestation and on combination antiretroviral therapy initially received lopinavir/ritonavir 400 mg/100 mg (two 200/50 mg tablets) twice daily up to a gestational age of 30 weeks.
Danish: I et åbent farmakokinetisk studie, fik 12 hiv-inficerede gravide kvinder, som var under 20. gestationsuge og i antiretroviral kombinationsbehandling, lopinavir/ritonavir 400 mg/100 mg (to 200/50 mg tabletter) to gange dagligt frem til gestationsalder på 30 uger.
English: The Kaletra tablets dosage should be increased to 500/125 mg twice daily when co-administered with efavirenz.
Danish: Kaletra-tablet-dosis bør øges til 500/125 mg to gange dagligt ved samtidig administration med efavirenz.
English: The Kaletra tablets dosage should be increased to 500/125 mg twice daily when co-administered with nevirapine.
Danish: Kaletra-tablet-dosis bør øges til 500/125 mg to gange dagligt ved samtidig administration med nevirapin.
English: AUC: ↔ Cmin: ↑ 3.5-fold Cmax: ↓
Danish: Cmin: ↑ 3.5-fold Cmax: ↓
English: Sixty-one patients completed the study (35 patients received the recommended 400/100 mg twice daily dose throughout the study).
Danish: 61 patienter fuldførte studiet (35 patienter fik den anbefaldede dosis 400/100 mg to gange dagligt gennem hele studiet).
English: Increased plasma concentrations of amiodarone and dronedarone.
Danish: Forhøjede plasmakoncentrationer af amiodaron og dronedaron.
English: Concomitant use of sildenafil prescribed for the treatment of pulmonary arterial hypertension with Kaletra is contraindicated (see section 4.3).
Danish: Samtidig brug af sildenafil ordineret til behandling af pulmonal arteriel hypertension og Kaletra er kontraindiceret (se pkt.
English: Uncommon Cerebrovascular accident, convulsion, dysgeusia, ageusia, tremor
Danish: Ikke almindelig Cerebrovaskulært attak, kramper, dysgeusi, agusi, tremor
English: However, if it is judged necessary to resort to solid oral dosage form for children weighing less than 40 kg or with a BSA between 0.5 and 1.4 m2 and able to swallow tablets, Kaletra 100 mg/25 mg tablets may be used.
Danish: Hvis det findes nødvendigt at anvende tabletter til børn, som vejer mindre end 40 kg eller har et legemsoverfladeareal mellem 0,5 og 1,4 m2, og som er i stand til at synke tabletter, kan Kaletra 100 mg/25 mg tabletter bruges.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 200 mg/50 mg tablets - Blister of 8 film-coated tablets or Blister of 12 film-coated tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS 200/50 mg filmovertrukne tabletter blisterkort med 8 filmovertrukne tabletter eller blisterkort med 12 filmovertrukne tabletter
English: Abacavir, Zidovudine Abacavir, Zidovudine: Concentrations may be reduced due to increased glucuronidation by lopinavir/ritonavir.
Danish: Abacavir, zidovudin Abacavir, zidovudin: Koncentrationerne kan være nedsat på grund af øget glucuronidering af lopinavir/ritonavir.
English: Increased risk of tumor lysis syndrome at the dose initiation and during the ramp-up phase (see section
Danish: Øget risiko for tumorlysesyndrom ved dosisinitiering og under dosistitreringsfasen (se pkt.
English: • fusidic acid used to treat long-term infections of the bones and joints (e.g. osteomyelitis);
Danish: • fusidinsyre brugt til behandling af langvarige infektioner i knogler og led (f.eks.osteomyelitis);
English: Study P1030 was an open-label, dose-finding trial evaluating the pharmacokinetic profile, tolerability, safety and efficacy of Kaletra oral solution at a dose of 300 mg lopinavir/75 mg ritonavir per m2 twice daily plus 2 NRTIs in HIV-1 infected infants ≥ 14 days and < 6 months of age.
Danish: Studie P1030 var et åbent dosis-bestemmelsestudie, hvor den farmakokinetiske profil, tolerabilitet, sikkerhed og virkning af Kaletra oral opløsning blev evalueret ved en dosis på 300 mg lopinavir/75 mg ritonavir pr. m2 to gange dagligt plus 2 nukleosid reverstranskriptasehæmmere i nyfødte ≥ 14 dage til < 6 måneder smittet med hiv-1.
English: Therefore, Kaletra can be started safely 2 weeks after cessation of St John's wort.
Danish: Derfor kan behandling med Kaletra kan startes sikkert 2 uger efter ophør med at behandle med perikon.
English: Phenytoin levels should be monitored when co-administering with Kaletra.
Danish: Phenytoin-niveauerne bør overvåges ved samtidig administration med Kaletra.
English: Data from clinical trials in children below 2 years of age include the pharmacokinetics of Kaletra 300/75 mg/m2 twice daily studied in a total of 31 paediatric patients, ranging in age from 14 days to 6 months.
Danish: Data fra kliniske studier med børn under 2 år inklusive Kaletras farmakokinetik for 300/75 mg/m2 to gange dagligt omfatter i alt 31 pædiatriske patienter i alderen fra 14 dage til 6 måneder.
English: Therefore, if co-administration of delamanid with lopinavir/ritonavir is considered necessary, very frequent ECG monitoring throughout the full delamanid treatment period is recommended (see section 4.5 and refer to the delamanid SmPC).
Danish: Hvis samtidig administration af delamanid og lopinavir/ritonavir anses for nødvendig, anbefales derfor meget hyppig EKG-monitorering under hele behandlingen med delamanid (se pkt.
English: Alcohol, high fructose corn syrup, propylene glycol, purified water, glycerol, povidone, magnasweet110 flavour (mixture of monoammonium glycyrrhizinate and glycerol), vanilla flavour (containing p-hydroxybenzoic acid, p-hydroxybenzaldehyde, vanillic acid, vanillin, heliotropin, ethyl vanillin), polyoxyl 40 hydrogenated castor oil, cotton candy flavour (containing ethyl maltol, ethyl vanillin, acetoin, dihydrocoumarin, propylene glycol), acesulfame potassium, saccharin sodium, sodium chloride, peppermint oil, sodium citrate, citric acid, levomenthol.
Danish: Alkohol, majssirup med højt fruktoseindhold, propylenglykol, renset vand, glycerol, povidon, magnasweet-110 aroma (blanding af monoammonium glycyrrhizinat og glycerol), vaniljearoma (indeholdende p-hydroxybenzoesyre, p-hydroxybenzaldehyd, vanillinsyre, vanillin, heliotropin, ethylvanillin), polyoxyleret (40) hydrogeneret ricinusolie, sukkervataroma (indeholdende ethylmaltol, ethylvanillin, acetoin, dihydrocoumarin, propylenglycol), kaliumacesulfam, saccharinnatrium, natriumchlorid, pebermynteolie, natriumcitrat, citronsyre, levomenthol.
English: Table 5
Danish: Tabel 5
English: Calcium channel blockers Felodipine, Nifedipine, and Nicardipine
Danish: Calcium-antagonister Felodipin, nifedipin og nicardipin
English: The pharmacokinetic properties of lopinavir co-administered with ritonavir have been evaluated in healthy adult volunteers and in HIV-infected patients; no substantial differences were observed between the two groups.
Danish: De farmakokinetiske egenskaber af lopinavir administreret sammen med ritonavir er blevet vurderet i raske, voksne frivillige og i hiv-smittede patienter.
English: Uncommon Gastrointestinal haemorrhage including gastrointestinal ulcer, duodenitis, gastritis and rectal haemorrhage, stomatitis and oral ulcers, faecal incontinence, constipation, dry mouth
Danish: Ikke almindelig Gastrointestinal blødning inklusive gastrointestinal ulcus, duodenit, gastrit og rektalblødning, stomatit og mundsår, fækal inkontinens, obstipation, mundtørhed
English: The adverse reactions are displayed by system organ class.
Danish: Bivirkningerne er opført efter organsystemet.
English: • colchicine (used to treat gout) if you have kidney and/or liver problems (see the section on
Danish: • colchicin (brugt til behandling af urinsyregigt), hvis du har problemer med nyre- og/eller lever (se punktet Brug af anden medicin sammen med Kaletra);
English: • dry mouth;
Danish: • tør mund;
English: When given with Kaletra the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example MondayWednesday-Friday).
Danish: Ved administration sammen med Kaletra er den anbefalede rifabutindosis 150 mg 3 gange om ugen på fastsatte dage (for eksempel mandagonsdag-fredag).
English: Using the 5 ml oral dosing syringe for doses more than 2 ml
Danish: Brug doseringssprøjten på 5 ml til doser på mere end 2 ml
English: Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e.g. budesonide and triamcinolone.
Danish: Systemiske kortikosteroid-virkninger, inklusive Cushings syndrom og adrenal suppression, er rapporteret hos patienter, der fik ritonavir og inhaleret eller intranasalt administreret fluticasonpropionat; dette kan også forekomme med andre kortikosteroider, som metaboliseres via P450 3A, f.eks. budesonid og triamcinolon.
English: Lipid lowering agents Lovastatin and Simvastatin
Danish: Lipidsænkende midler Lovastatin og simvastatin
English: • medicines used to lower blood cholesterol (e.g. atorvastatin, lovastatin, rosuvastatin or simvastatin);
Danish: • lægemidler, der anvendes til at sænke kolesterolniveauet i blodet (f.eks. atorvastatin, lovastatin,
English: Concomitant Therapy: Efavirenz or Nevirapine
Danish: Samtidig behandling: Efavirenz eller nevirapin
English: Potential for serious and/or life-threatening reactions in patients with renal and/or hepatic impairment (see sections 4.4 and 4.5).
Danish: Risiko for alvorlige og/eller livstruende reaktioner hos patienter med nedsat nyre- og/eller leverfunktion (se pkt.
English: Outcomes at Week 48: Study M98-940 Antiretroviral Naïve (N=44)
Danish: Resultater ved uge 48: Studie M98-940 Antiretroviral naive (N=44)
English: Concomitant use of Kaletra and fluticasone or other glucocorticoids that are metabolised by CYP3A4, such as budesonide and triamcinolone, is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
Danish: Samtidig brug af Kaletra og fluticason eller andre glukokorticoider, som metaboliseres af CYP3A4, såsom budesonid og triamcinolon, anbefales ikke, med mindre de mulige fordele ved behandlingen opvejer risikoen for systemiske virkninger af kortikosteroider, inklusive Cushings syndrom og binyrebarksuppression (se punkt 4.5).