FrancophonIA/ELRC3.0 huggingface dataset:
English: The maximum mean PR interval changes relative to the pre-dose baseline value were 25 msec and 34 msec in the two ritonavir-boosted Invirase treatment groups, 1000/100 mg twice daily and 1500/100 mg twice daily, respectively (also see section 4.4).
Danish: De maksimale gennemsnitlige ændringer i PR-intervallet relativt til præ-dosis baselineværdien var 25 ms og 34 ms i de to ritonavirboostede Invirase-behandlingsgrupper; henholdsvis 1.000/100 mg 2 gange daglig og 1.500/100 2 gange daglig (se også pkt.
English: How to take
Danish: Sådan skal du tage
English: No data are available on the concomitant administration of Invirase/ritonavir and other proton pump inhibitors.
Danish: Der er ingen tilgængelig data om samtidig administration af Invirase/ritonavir og andre syrepumpehæmmere.
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.
Danish: Hos patienter, der fik ritonavir og inhaleret eller intranasalt fluticasonpropionat, er der rapporteret om systemiske bivirkninger forårsaget af kortikosteroider, herunder Cushings syndrom og binyrebarksuppression, hvilket også kan forekomme med andre kortikosteroider, som metaboliseres via P450 3A, som f.eks. budesonid.
English: Light orange to greyish or brownish orange film-coated tablet of oval cylindrical biconvex shape with the marking "SQV 500" on the one side and "ROCHE" on the other side.
Danish: Lyseorange til grålig- eller brunligorange filmovertrukne, ovale, cylindriske, bikonvekse tabletter mærket ” SQV 500” på den ene side og ”ROCHE” på den anden side.
English: Antiretroviral naïve (%) PI naïve (%)
Danish: PI-naive (%)
English: Adverse reactions from two pivotal studies of saquinavir soft capsule (1000 mg twice daily) used in combination with low dose ritonavir (100 mg twice daily) for at least 48 weeks are summarised in Table 2.
Danish: Bivirkninger fra to pivotale studier med saquinavir bløde kapsler (1.000 mg 2 gange daglig) anvendt i kombination med lavdosis ritonavir (100 mg 2 gange daglig) i mindst 48 uger er opstillet i tabel 2.
English: Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Danish: Stivhed, ømhed og smerter i leddene (især hofte, knæ og skulder) samt bevægelsesbesvær er tegn på knoglenekrose.
English: Nefazodone inhibits CYP3A4.
Danish: - Nefazodon hæmmer CYP3A4.
English: Virological response was first observed to decrease when the fold shift exceeded 2.3-fold; whereas virological benefit was not observed when the fold shift exceeded 12-fold.
Danish: Det blev først observeret, at virologisk respons faldt, når ændringen var større end 2,3 gange.
English: • certain heart medicines - such as calcium channel blockers, quinidine, digoxin
Danish: • visse former for hjertemedicin - såsom calciumantagonister, kinidin, digoxin
English: Interaction with ritonavir: The recommended dose of Invirase and ritonavir is 1000 mg Invirase plus 100 mg ritonavir twice daily.
Danish: Interaktion med ritonavir: De anbefalede doser af Invirase og ritonavir er 1.000/100 mg 2 gange daglig.
English: Careful therapeutic drug monitoring is necessary for these immunosuppressants when coadministered with Invirase/ritonavir.
Danish: Nøje monitorering af de terapeutiske koncentrationer af de immunsuppressive lægemidler er nødvendig, når de gives sammen med Invirase/ritonavir.
English: Saquinavir ↑ 50% (normal strength grapefruit juice)
Danish: - Saquinavir ↑ 50 % (normal styrke grapefrugtjuice) - Saquinavir ↑ 100 % (dobbelt styrke grapefrugtjuice).
English: Patients initiating therapy with ritonavir-boosted Invirase: - An ECG should be performed on all patients prior to initiation of treatment: patients with a QT interval > 450 msec should not use ritonavir-boosted Invirase.
Danish: Patienter, som starter behandling med ritonavirboostet Invirase: - Før opstart af behandling skal der tages et ekg på alle patienter: Patienter med et QTinterval > 450 ms bør ikke behandles med ritonavirboostet Invirase.For patienter med et QT-interval < 450 ms anbefales det at tage et opfølgende ekg, når behandlingen er påbegyndt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 500 mg of saquinavir as saquinavir mesilate.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En Invirase filmovertrukken tablet indeholder 500 mg saquinavir som saquinavirmesilat.
English: Plasma concentrations highly dependent on CYP3A4 metabolism.
Danish: Plasmakoncentrationen afhænger i høj grad af CYP3A4-metabolisme.
English: Combination not recommended as may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia (see section 4,4).
Danish: Kombinationen anbefales ikke, da den kan øge risikoen for kardiovaskulære bivirkninger associeret med salmeterol, inklusive QTforlængelse, palpitationer og sinustakykardi.
English: Saquinavir does not induce chromosomal damage in vivo in the mouse micronucleus assay or in vitro in human peripheral blood lymphocytes and does not induce primary DNA damage in vitro in the unscheduled DNA synthesis test.
Danish: Saquinavir inducerer ikke kromosomale skader in vivo i en mikronukleus-test på mus eller in vitro i humane perifere blodlymfocytter.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Danish: Særligt hos patienter med generelt anerkendte risikofaktorer, fremskreden hiv-sygdom eller langvarig kombinationsbehandling med antiretrovirale lægemidler (CART) er der rapporteret om tilfælde af osteonekrose.
English: Dexamethasone induces CYP3A4 and may decrease saquinavir concentrations.
Danish: - Dexamethason inducerer CYP3A4 og kan nedsætte koncentrationer af saquinavir.
English: • Take one 500 mg film-coated tablet of Invirase twice a day.
Danish: • Tag én 500 mg filmovertrukken Invirase tablet to gange daglig
English: Dose-dependent prolongations of QT and PR intervals have been observed in healthy volunteers receiving ritonavir-boosted Invirase (see section 5.1).
Danish: Der er observeret dosisafhængige forlængelser af QT- og PR-intervaller hos raske frivillige, som fik ritonavirboostet Invirase (se pkt.
English: • anticonvulsants - such as phenobarbital, phenytoin, carbamazepine
Danish: • epilepsimedicin - såsom phenobarbital, phenytoin og carbamazepin
English: No dose adjustment required for Invirase/ritonavir.
Danish: Dosisjustering ikke nødvendig for Invirase/ritonavir.
English: These medicinal products will induce CYP3A4 and may therefore decrease saquinavir concentrations
Danish: Disse lægemidler inducerer CYP3A4 og kan derfor nedsætte koncentrationen af saquinavir.
English: Contraindicated in combination with saquinavir/ritonavir, due to the risk of potentially prolonged or increased sedation and respiratory depression (see section 4.3).
Danish: Triazolam er kontraindiceret sammen med saquinavir/ritonavir på grund af risikoen for forlænget eller øget sedation og respirationsdepression (se pkt.
English: Invirase/ritonavir is contraindicated in patients with decompensated liver disease (see section 4.3).
Danish: Invirase/ritonavir er kontraindiceret til patienter med dekompenseret leversygdom (se pkt.
English: The following adverse events with an at least possible relationship to ritonavir boosted saquinavir (i.e. adverse reactions) were reported most frequently: nausea, diarrhoea, fatigue, vomiting, flatulence, and abdominal pain.
Danish: Følgende uønskede hændelser med i det mindste en mulig sammenhæng med ritonavir boostet saquinavir (dvs. bivirkninger) og blev rapporteret hyppigst: Kvalme, diarré, træthed, opkastning, flatulens og mavesmerter.
English: Co-administration of fusidic acid and Invirase/ritonavir can cause increased plasma concentration of both fusidic acid and saquinavir/ritonavir.
Danish: Samtidig administration af fusidinsyre og Invirase/ritonavir kan medføre øget plasmakoncentration af både fusidinsyre og saquinavir/ritonavir.
English: For treatment-naive patients initiating treatment with Invirase/ritonavir, the starting recommended dose of Invirase is 500 mg (1 x 500 mg film-coated tablet) two times daily with ritonavir 100 mg two times daily in combination with other antiretroviral agents for the first 7 days of treatment.
Danish: For behandlingsnaive patienter, som skal påbegynde behandling med Invirase/ritonavir, er den anbefalede startdosis af Invirase 500 mg (1 x 500 mg filmovertrukken tablet) 2 gange daglig med 100 mg ritonavir 2 gange daglig i kombination med andre antiretrovirale stoffer i de første 7 dage af behandlingen.
English: Sultopride
Danish: Sultoprid
English: Concomitant use of bosentan and saquinavir/ritonavir may increase plasma levels of bosentan and may decrease plasma levels of saquinavir/ritonavir.
Danish: Samtidig brug af bosentan og saquinavir/ritonavir kan øge plasmakoncentrationen af bosentan og nedsætte plasmakoncentrationen af saquinavir/ritonavir.
English: Antidepressants Tricyclic antidepressants (e.g. amitriptyline, imipramine, clomipramine) (saquinavir/ritonavir)
Danish: Antidepressiva Tricykliske antidepressiva (f.eks. amitriptylin, imipramin, clomipramin) (saquinavir/ritonavir)
English: No dosage adjustment is necessary for patients with mild to moderate renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion.
English: Limited data is available from two clinical studies where the safety of saquinavir soft capsule (1000 mg twice daily) used in combination with low dose ritonavir (100 mg twice daily) for at least 48 weeks was studied in 311 patients.
Danish: Der er begrænset information om sikkerheden fra to kliniske studier, hvor saquinavir bløde kapsler (1000 mg 2 gange daglig) blev anvendt i kombination med lavdosis ritonavir (100 mg 2 gange daglig) i mindst 48 uger hos i 311 patienter.
English: Saquinavir AUC0-12 ↓ 13% (90% CI: 31↓ - 9↑) Saquinavir Cmax ↓ 15% (90% CI: 32↓ - 7↑) Ritonavir AUC0-12 ↔ (90% CI: 10↓ - 9↑) Ritonavir Cmax ↔ (90% CI: 8↓ - 7↑)
Danish: Saquinavir AUC0-12 ↓ 13 % (90 % konfidensinterval: 31 ↓ - 9 ↑) Saquinavir Cmax ↓ 15 % (90 % konfidensinterval: 32 ↓ - 7 ↑) Ritonavir AUC0-12 ↔ (90 % konfidensinterval: 10 ↓ - 9 ↑) Ritonavir Cmax ↔ (90 % konfidensinterval: 8 ↓ - 7 ↑).
English: No dose adjustment of saquinavir/ritonavir is required.
Danish: Dosisjustering ikke nødvendig for saquinavir/ritonavir.
English: (90% CI 146%-193%) Ketoconazole Cmax ↑ 45% (90% CI 32%-59%)
Danish: (90 % konfidensinterval: 146 %-193 %) Ketoconazol Cmax ↑ 45 % (90 % konfidensinterval: 32 %-59 %)
English: • medicines for erectile dysfunction - sildenafil, vardenafil, tadalafil
Danish: • lægemidler til behandling af impotens - sildenafil, vardenafil, tadalafil
English: Concentrations of bepridil, systemic lidocaine, quinidine or hydroquinidine may be increased when co-administered with Invirase/ritonavir.
Danish: Koncentrationen af bepridil, systemisk lidocain kinidin eller hydrokinidin kan være øget ved co-administration med Invirase/ritonavir.
English: These medicinal products are contraindicated for use with Invirase/ritonavir (see section 4.3).
Danish: Disse lægemidler er derfor kontraindiceret til anvendelse sammen med Invirase/ritonavir (se pkt.
English: Day 10
Danish: Dag 10
English: The most frequently (in more than ten in a hundred persons) reported side effects of saquinavir taken with ritonavir concern the gastrointestinal tract, with feeling sick, diarrhoea, tiredness, vomiting, wind and abdominal pain being the most common.
Danish: De hyppigst (hos flere end 10 ud af 100 patienter) rapporterede bivirkninger af saquinavir taget sammen med ritonavir vedrører mave-tarmkanalen såsom utilpashed, diarré, træthed, opkastning, prutten og mavesmerter som de mest almindelige.
English: The recommended dose of Invirase is 1000 mg (2 x 500 mg film-coated tablets) two times daily with ritonavir 100 mg two times daily in combination with other antiretroviral agents.
Danish: Den anbefalede dosis af Invirase er 1.000 mg (2 x 500 mg filmovertrukne tabletter) 2 gange daglig sammen med 100 mg ritonavir 2 gange daglig i kombination med andre antiretrovirale stoffer.
English: Co-administration of Invirase/ritonavir with orally administered midazolam is contraindicated (see section 4.3).
Danish: Samtidig administration af Invirase/ritonavir og oralt administreret midazolam er kontraindiceret (se pkt.
English: Halofantrine Pentamidine Sparfloxacin (saquinavir/ritonavir)
Danish: - Halofantrin Pentadimin Sparfloxacin (saquinavir/ritonavir)
English: • certain strong pain killers (narcotics) - such as alfentanyl, fentanyl, methadone
Danish: • visse lægemidler mod stærke smerter (narkotiske analgetika) - såsom alfentanyl, fentanyl,
English: - Grapefruit juice (saquinavir/ritonavir)
Danish: - Grapefrugtjuice (saquinavir/ritonavir)
English: • Take two 500 mg film-coated tablets of Invirase twice a day.
Danish: • Tag to 500 mg Invirase filmovertrukne tabletter to gange daglig
English: Limited safety data are available from a paediatric study (NV20911, n=18) in which the safety of saquinavir hard capsules (50 mg/kg bid, not to exceed 1000 mg bid) used in combination with low dose ritonavir oral solution (3 mg/kg bid for body weight from 5 to <15 kg, 2.5 mg/kg bid for body weight from 15 to 40 kg and 100 mg bid for body weight >40 kg) has been studied in paediatric patients aged 4 months to 6 years old.
Danish: Begrænsede sikkerhedsdata er tilgængelige fra et pædiatrisk studie (NV20911, n=18), der undersøgte sikkerheden af saquinavir hårde kapsler (50 mg/kg 2 gange daglig, dog højst 1.000 mg 2 gange daglig) i kombination med lavdosis ritonavir oral opløsning (3 mg/kg 2 gange daglig ved legemsvægt fra 5 kg til < 15 kg, 2,5 mg/kg 2 gange daglig ved legemsvægt fra 15 kg til 40 kg og 100 mg 2 gange daglig ved en legemsvægt > 40 kg) hos pædiatriske patienter i alderen 4 måneder til 6 år.
English: NAME OF THE MEDICINAL PRODUCT INVIRASE 500 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN INVIRASE 500 mg filmovertrukne tabletter.
English: No dosage adjustment is necessary for HIV-infected patients with mild hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos hiv-inficerede patienter med let nedsat leverfunktion.
English: John's wort must not be used concomitantly with Invirase.
Danish: Naturlægemidler indeholdende perikon må ikke anvendes samtidig med Invirase.
English: Invirase should only be given in combination with ritonavir (see section 4.2).
Danish: Invirase bør kun gives i kombination med ritonavir (se pkt.
English: Interaction with Invirase/ritonavir not studied.
Danish: Interaktion med Invirase/ritonavir er ikke undersøgt.
English: - Nevirapine (unboosted saquinavir)
Danish: - Nevirapin (ikke-boostet saquinavir)
English: (90% CI 98%-167%) Rifabutin AUC0-72 ↑ 53% (90% CI 36%-73%) Rifabutin Cmax ↑ 86% (90% CI 57%-119%)
Danish: (90 % konfidensinterval: 98 %-167 %) Rifabutin AUC0-72 ↑ 53 % (90 % konfidensinterval: 36 %-73 %) Rifabutin Cmax ↑ 86 % (90 % konfidensinterval: 57 %-119 %).
English: Close monitoring of safety (including signs of cardiac arrhythmia) and of virologic response is recommended due to increased variability of the exposure in this population (see sections 4.2 and 5.2).
Danish: Tæt monitorering af sikkerhed (herunder tegn på hjertearytmi) og virologisk respons anbefales på grund af øget variabilitet i eksponeringen hos denne population (se pkt.
English: Note: QTcS in this study was QT/RR0.319 for males and QT/RR0.337 for females, which are similar to Fridericia's correction (QTcF=QT/RR0.333).
Danish: 4 timer † Afledt ændring fra præ-dosis baseline-korrigeret QTcS mellem aktiv behandlingsarm og placeboarm ^ 400 mg blev kun administreret på dag 3 Bemærk: QTcS var i dette studie QT/RR0,319 for mænd og QT/RR0,337 for kvinder, hvilket svarer til Fridericia's korrektion (QTcF=QT/RR0,333).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 04 October 1996
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Manufacturer Roche Pharma AG, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany.
Danish: Roche Pharma AG, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Tyskland.
English: (90 % CI 44-131 %) Saquinavir Cmax ↑ 75% (90 % CI 38-123 %) Ritonavir ↔
Danish: (90 % konfidensinterval 44 - 131 %) Saquinavir Cmax ↑ 75 % (90 % konfidensinterval 38 - 123 %) Ritonavir ↔
English: Concomitant administration of tipranavir, co-administered with low dose ritonavir, with saquinavir/ritonavir, is not recommended.
Danish: Administration af tripranavir + lavdosis ritonavir, samtidig med saquinavir/ritonavir anbefales ikke.
English: Benzodiazepines Midazolam 7.5 mg single dose (oral) (saquinavir/ritonavir 1000/100 mg bid)
Danish: Benzodiazepiner Midazolam 7,5 mg enkeltdosis (oral) (saquinavir/ritonavir 1.000/100 mg 2 gange daglig)
English: • medicines used to treat asthma or other chest illness such as Chronic Obstructive Pulmonary
Danish: • lægemidler til behandling af astma eller andre lungesygdomme, f.eks. kronisk obstruktiv lungesygdom (KOL) - såsom salmeterol
English: Saquinavir AUC ↑ 4.6-7.2 fold
Danish: - Saquinavir AUC ↑ 4,6-7,2 gange
English: Rilpivirine
Danish: Rilpivirin
English: No dose adjustment of saquinavir recommended.
Danish: Dosisjustering af saquinavir anbefales ikke.
English: SQV Naive Population
Danish: Marcelin et al (2007) SQV Naiv population
English: In treatment-naïve HIV-1 infected patients initiating Invirase/ritonavir treatment with a modified Invirase/ritonavir dosing regimen of Invirase 500 mg two times daily with ritonavir 100 mg two times daily for the first 7 days of treatment and increased to Invirase 1000 mg two times daily with ritonavir 100 mg two times daily in the subsequent 7 days, saquinavir systemic exposures generally approached or exceeded the range of historical steady-state values with the standard Invirase/ritonavir 1000 mg/100 mg bid dosing regimen across study days (see Tables 9 and 8).
Danish: Hos behandlingsnaive hiv-1-inficerede patienter, der påbegyndte Invirase/ritonavir-behandling med et modificeret Invirase/ritonavir-dosisregime bestående af Invirase 500 mg 2 gange daglig med ritonavir 100 mg 2 gange daglig i de første 7 dage af behandlingen og derefter øget til Invirase 1.000 mg 2 gange daglig med ritonavir 100 mg 2 gange daglig i de efterfølgende 7 dage, nærmede eller oversteg saquinavirs systemiske tilgængelighed generelt niveauet af tidligere steady state værdier for standarddosisregimet bestående af Invirase/ritonavir 1.000 mg/ 100 mg to gange daglig hen over forsøgsdagene (se tabel 9 og 8).
English: • a history of an irregular heart beat (arrhythmias)
Danish: • hvis du tidligere har haft uregelmæssig hjerterytme (arytmier)
English: Absorption: In HIV-infected adult patients, Invirase in combination with ritonavir at doses of 1000/100 mg twice daily provides saquinavir systemic exposures over a 24-hour period similar to or greater than those achieved with saquinavir soft capsules 1200 mg tid (see Table 8).
Danish: Absorption: Hos hiv-inficerede voksne patienter giver Invirase i kombination med ritonavir i doser på 1.000/100 mg 2 gange daglig en systemisk tilgængelighed af saquinavir over en 24-timers periode svarende til eller højere end opnåede værdier med saquinavir bløde kapsler 1.200 mg 3 gange daglig (se tabel 8).
English: Amiodarone flecainide propafenone (saquinavir/ritonavir)
Danish: Amiodaron flecainid propafenon (saquinavir/ritonavir)
English: Other medicinal products known to increase the plasma concentration of ritonavir-boosted Invirase should be used with caution.
Danish: Der bør udvises forsigtighed ved anvendelse af andre lægemidler, som er kendt for at øge plasmakoncentrationen af ritonavirboostet Invirase.
English: Maprotiline's metabolism appears to involve the cytochrome P450 isozymes CYP2D6 and CYP 1A2 Associated with a prolongation of QTc intervals.
Danish: Maprotelins metabolisme synes at involvere CYP2D6 og CYP1A2.
English: Concentrations of amiodarone, flecainide or propafenone may be increased when co-administered with Invirase/ritonavir.
Danish: Koncentrationer af amiodaron, flecainid eller propafenon kan være øget ved coadministration med Invirase/ritonavir.
English: Microcrystalline cellulose, Croscarmellose sodium, Povidone,
Danish: Mikrokrystallinsk cellulose Croscarmellosenatrium Povidon
English: In the therapeutic and the supra-therapeutic arm 11% and 18% of subjects, respectively, had a QTcS between 450 and 480 msec.
Danish: I den terapeutiske og den supraterapeutiske arm havde henholdsvis 11 % og 18 % af forsøgspersonerne en QTcS mellem 450 og 480 ms. Der var ingen QT-forlængelse > 500 ms og ingen torsades de pointes-takykardi i studiet (se også pkt.
English: - Garlic capsules (dose approx. equivalent to two 4 g cloves of garlic daily) (unboosted saquinavir 1200 mg tid)
Danish: - Hvidløgskapsler (dosis svarer til ca. to fed hvidløg på 4 g hver daglig) (ikke-boostet saquinavir 1.200 mg 3 gange daglig)
English: Interaction with efavirenz: The combination of saquinavir and ritonavir with efavirenz has been shown to be associated with an increased risk of liver toxicity; liver function should be monitored when saquinavir and ritonavir are co-administered with efavirenz.
Danish: Interaktion med efavirenz: Det har vist sig, at kombinationen af saquinavir og ritonavir med efavirenz er forbundet med en øget risiko for levertoksicitet.
English: One film-coated tablet of Invirase contains 500 mg of saquinavir as saquinavir mesilate.
Danish: En Invirase filmovertrukken tablet indeholder 500 mg saquinavir som saquinavirmesilat.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 500 mg of saquinavir as saquinavir mesilate.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukken tablet indeholder 500 mg saquinavir som saquinavirmesilat.
English: D.
Danish: N
English: In combination with ritonavir, bioequivalence of Invirase hard capsules and film-coated tablets was demonstrated under fed conditions.
Danish: Bioækvivalensen af Invirase hårde kapsler og filmovertrukne tabletter blev undersøgt i kombination med ritonavir hos patienter efter fødeindtagelse.
English: Lopinavir/ritonavir 400/100 mg bid (saquinavir 1000 mg bid in combination with 2 or 3 NRTIs)
Danish: Lopinavir/ritonavir 400/100 mg 2 gange daglig (saquinavir 1.000 mg 2 gange daglig i kombination med 2 eller 3 NRTIs)
English: • severe liver problems such as jaundice, hepatitis or liver failure - where your belly fills with fluid,
Danish: • hvis du lider af en alvorlig leversygdom såsom gulsot, leverbetændelse eller leversvigt - hvor du har væskeophobning i maven, bliver forvirret eller bløder fra spiserøret
English: Since saquinavir is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.
Danish: Det er usandsynligt, at dialyse signifikant kan fjerne det aktive stof, da saquinavir er stærkt proteinbundet.
English: In the MaxCmin1 study, the safety and efficacy of saquinavir soft capsules/ritonavir 1000/100 mg twice daily plus 2 NRTIs/Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) was compared to indinavir/ritonavir 800/100 mg twice daily plus 2 NRTIs/NNRTIs in over 300 (both protease inhibitor treatment naïve and experienced) subjects.
Danish: I MaxCmin1-studiet, blev sikkerhed og effekt af saquinavir bløde kapsler/ritonavir 1.000/100 mg 2 gange daglig plus 2 NRTI/Non-nukleosid reverse transkriptasehæmmere (NNRTI) sammenlignet med indinavir/ritonavir 800/100 mg 2 gange daglig plus 2 NRTI/NNRTI i over 300 patienter (både naive og tidligere proteasehæmmerebehandlede).
English: Saquinavir/ritonavir concentrations not measured, no effect is expected.
Danish: Saquinavir/ritonavir-koncentrationer er ikke målt.
English: • certain medicines that may be used for a variety of things: cisapride, diphemanil, mizolastine,
Danish: • visse andre lægemidler som kan benyttes mod forskellige sygdomme: cisaprid, difemanil,