FrancophonIA/ELRC3.0 huggingface dataset:
English: There is a heterogeneous effect of telaprevir on ritonavir-boosted protease inhibitor drug plasma levels, depending on the protease inhibitors.
Danish: Telaprevir har en heterogen virkning på plasmakoncentrationen af ritonavir-forstærkede proteasehæmmere, afhængigt af proteasehæmmeren.
English: Absorption of tipranavir, co-administered with low dose ritonavir, is reduced in the presence of antacids (see section 4.5).
Danish: Absorption af tipranavir plus lavdosis ritonavir nedsættes ved tilstedeværelsen af antacida (se pkt.
English: Tell your child's doctor if they have: - type A or B haemophilia - diabetes - liver disease.
Danish: Fortæl det til lægen eller apotekspersonalet, hvis dit barn har nogen af nedenstående sygdomme eller tilstande: - blødersygdom, type A eller B - diabetes - leversygdom.
English: In addition, co-administration of Aptivus with low dose ritonavir, and medicinal products that are highly dependent on CYP2D6 for clearance, such as the antiarrhythmics flecainide, propafenone and metoprolol given in heart failure (see section 4.5).
Danish: Desuden er samtidig behandling med Aptivus plus lavdosis ritonavir og lægemidler, der i udstrakt grad nedbrydes via CYP2D6 såsom følgende antiarytmika flecainid, propafenon og metoprolol anvendt ved hjertesvigt (se pkt.
English: Your child's doctor will carefully consider whether to treat them with combinations of Aptivus and protease inhibitors.
Danish: Lægen vil vurdere, om dit barn skal behandles med en kombination af Aptivus og disse proteasehæmmere.
English: Saquinavir/ritonavir 600/100 mg QD
Danish: Saquinavir/ritonavir 600/100 mg x 1
English: No dosage adjustment necessary.
Danish: Dosisjustering er ikke nødvendig.
English: These active substances include antiarrhythmics (such as amiodarone, bepridil, quinidine), antihistamines (such as astemizole, terfenadine), ergot derivatives (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (such as cisapride), antipsychotics (such as pimozide, sertindole, quetiapine, lurasidone), sedatives/hypnotics (such as orally administered midazolam and triazolam) and HMG-CoA reductase inhibitors (such as simvastatin and lovastatin) (see section 4.5).
Danish: Disse aktive substanser omfatter antiarytmika (såsom amiodaron, bepridil, quinidin), antihistaminer (såsom astemizol, terfenadin), sekalealkaloider (såsom dihydroergotamin, ergonovin, ergotamin, metylergonovin), peristaltikfremmende midler (såsom cisaprid), antipsykotika (såsom pimozid, sertindol, quetiapin, lurasidon), sedativa/hypnotika (såsom oralt administreret midazolam og triazolam og HMG-CoA reduktasehæmmere (såsom simvastatin og lovastatin) (se pkt.
English: Aptivus contains macrogolglycerol ricinoleate which may cause stomach upset and diarrhoea.
Danish: Aptivus indeholder polyoxyleret ricinusolie, som kan forårsage maveproblemer og diarre.
English: Carbamazepine total* Cmax ↑ 13% Carbamazepine total* AUC ↑ 16% Carbamazepine total* Cmin ↑ 23%
Danish: Antikonvulsiva Carbamazepin 200 mg x 2 Carbamazepin total* Cmax ↑ 13% Carbamazepin total* AUC ↑ 16% Carbamazepin total* Cmin ↑ 23%
English: In an open-label, dose-finding study of tipranavir plus ritonavir (Trial 1182.14), 28 children who were 12 years of age or above received Aptivus capsules.
Danish: I studie 1182.14, et åbent dosisbestemmelsesstudie med tipranavir og ritonavir, fik 28 børn på 12 år eller derover Aptivus kapsler.
English: Concomitant administration of Aptivus, co-administered with low dose ritonavir, and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Danish: Samtidig behandling med Aptivus plus lavdosis ritonavir og disse glukokortikoider anbefales derfor ikke, medmindre den potentielle fordel ved behandlingen opvejer risikoen for systemiske kortikosteroid-virkninger (se pkt.
English: Boceprevir exposure was reduced when co-administered with ritonavir-boosted lopinavir or ritonavir-boosted darunavir.
Danish: Boceprevireksponeringen blev reduceret, når det blev administreret sammen med ritonavirforstærket lopinavir eller ritonavirforstærket darunavir.
English: If you take aluminium- and magnesium-based antacid (used to treat dyspepsia/gastrooesophageal reflux), the time interval between Aptivus and antacid should be at least two hours.
Danish: Hvis du tager et aluminium- eller magnesiumholdigt syreneutraliserende middel (anvendes til behandling af for meget mavesyre/sure opstød), skal tidsintervallet mellem indtagelse af Aptivus og det syreneutraliserende middel være mindst to timer.
English: Antihistamines Astemizole Terfenadine No interaction study performed
Danish: Antihistaminer Astemizol Terfenadin Der er ikke udført interaktionsstudier.
English: Didanosine Cmax ↓ 43% Didanosine AUC ↓ 33%
Danish: Didanosin Cmax ↓ 43% Didanosin AUC ↓ 33%
English: What you need to know before you take Aptivus
Danish: Det skal du vide, før du begynder at tage Aptivus
English: Baseline characteristics for patients 2 - <12 years treated with Aptivus oral solution
Danish: Baseline karakteristik for patienter 2 - 12 år, som fik oral opløsning
English: Excipients with known effect: Each soft capsule contains 100.0 mg ethanol, 455.0 mg macrogolglycerol ricinoleate and 12.6 mg sorbitol For the full list of excipients, see section 6.1.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver kaspel indeholder 100,0 mg ethanol, 455,0 mg polyoxyleret ricinusolie og 12,6 mg sorbitol.
English: Aptivus soft capsules co-administered with low dose ritonavir should be taken with food (see section
Danish: Aptivus bløde kapsler plus lavdosis ritonavir bør tages sammen med mad (se pkt.
English: In use storage: 60 days (below 25°C) after first opening of the bottle.
Danish: Opbevaring efter anbrud: 60 dage (under 25ºC).
English: This leaflet was last approved in {MM/YYYY} Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ} Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk.
English: PP * Composite endpoint defined as patients with a confirmed 1 log RNA drop from baseline and without evidence of treatment failure ** Comparator PI/RTV: LPV/r 400 mg/100 mg twice daily (n=358), IDV/r 800 mg/100 mg twice daily (n=23), SQV/r 1000 mg/100 mg twice daily or 800 mg/200 mg twice daily (n=162), APV/r 600 mg/100 mg twice daily (n=194)
Danish: PP *Det endelige respons defineret som patienter med bekræftet 1 log RNA-fald i forhold til baseline og uden tegn på behandlingssvigt ** Komparator proteasehæmmer/RTV: LPV/r 400 mg/100 mg to gange daglig (n=358), IDV/r 800 mg/100 mg to gange daglig (n=23), SQV/r 1000 mg/100 mg to gange daglig eller 800 mg/200 mg to gange daglig (n=162), APV/r 600 mg/100 mg to gange daglig (n=194) ENF: Enfuvittide; FAS: Hele analysemateriale (Full Analysis Set); PP: Per protokol; APV/rtv: Amprenavir/ritonavir; IDA/rtv: Indinavir/ritonavir; LPV/rtv: Lopinavir/ritonavir; SQV/rtv: Saquinavir/ritonavir
English: Your child must take Aptivus together with:
Danish: Dit barn skal tage Aptivus sammen med følgende medicin:
English: Aptivus, co-administered with low dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated children from 2 to 12 years of age with virus resistant to multiple protease inhibitors.
Danish: Aptivus plus lavdosis ritonavir er indiceret som antiretroviral kombinationsbehandling af hiv-1 infektion til børn i alderen fra 2 til 12 år, som tidligere har været i omfattende behandling og med resistens over for mange proteasehæmmere.
English: Etravirine Cmax ↓ 71% Etravirine AUC ↓ 76% Etravirine Cmin ↓ 82%
Danish: Etravirin Cmax ↓ 71 % Etravirin AUC ↓ 76 % Etravirin Cmin ↓ 82 %
English: Steady-state tipranavir/r: S-warfarin Cmax ↓ 17% S-warfarin AUC ↓ 12%
Danish: Steady-statetipranavir/r: S-warfarin Cmax ↓ 17% S-warfarin AUC ↓ 12%
English: Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency (see sections 4.4 and
Danish: Patienter, der tager østrogen som hormonsubstitution, skal monitoreres klinisk for symptomer på østrogenmangel (se pkt.
English: These effects are called interactions, and can lead to serious side effects, or prevent proper control of other conditions you may have.
Danish: Disse virkninger kaldes for interaktioner, og kan i nogle tilfælde medføre alvorlige sygdomstilstande.
English: Unless otherwise stated, studies detailed below have been performed with the recommended dosage of Aptivus/r (i.e. 500/200 mg BID).
Danish: Medmindre andet er anført, er nedenstående studier udført med anbefalet dosis af Aptivus/ritonavir (500/200 mg 2 gange daglig).
English: If you get any side effects, please talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge eller apoteket.
English: If you forget to take Aptivus
Danish: Hvis du har glemt at tage Aptivus
English: You must take Aptivus together with ritonavir.
Danish: Du skal tage Aptivus sammen med ritonavir.
English: NAME OF THE MEDICINAL PRODUCT Aptivus 250 mg soft capsules
Danish: LÆGEMIDLETS NAVN Aptivus 250 mg bløde kapsler
English: What Aptivus looks like and contents of the pack Aptivus oral solution is a clear yellow liquid.
Danish: Aptivus oral opløsning er en klar gullig væske.
English: Rash:
Danish: Udslæt:
English: Mild to moderate rashes including urticarial rash, maculopapular rash, and photosensitivity have been reported in subjects receiving Aptivus, co-administered with low dose ritonavir.
Danish: Mildt til moderat udslæt, herunder urtikardielt udslæt, makulopapuløst udslæt og lysfølsomhed er rapporteret hos patienter, der har fået Aptivus sammen med lavdosis ritonavir.
English: In one particular in vitro resistance experiment, an HIV-1 isolate that was 87-fold resistant to tipranavir was selected after 9 months, and contained 10 mutations in the protease: L10F, I13V, V32I, L33F, M36I, K45I, I54V/T, A71V, V82L, I84V as well as a mutation in the gag polyprotein CA/P2 cleavage site.
Danish: I et bestemt in vitro resistensstudie blev der efter 9 måneder isoleret hiv-1 isolat, som var 87 gange resistent over for tipranavir, hvor det indeholdt 10 mutationer i proteasen: L10F, I13V, V32I, L33F, M36I, K45I, I54V/T, A71V, V82L, I84V samt en mutation på gag-polyprotein CA/P2-spaltningsstedet.
English: Conclusions regarding the relevance of particular mutations or mutational patterns are subject to change with additional data, and it is recommended to always consult current interpretation systems for analysing resistance test results.
Danish: Det anbefales, at man til enhver tid holder sig opdateret omkring de nyeste systemer til fortolkning af testresultater af resistensanalyser.
English: Clear yellow viscous liquid.
Danish: Klar gul viskøs opløsning.
English: A safe and effective dose has not been established when used with Aptivus, co-administered with low dose ritonavir.
Danish: Det har ikke været muligt at fastsætte en sikker og effektiv dosis ved samtidig brug af Aptivus plus lavdosis ritonavir.
English: Lopinavir/ritonavir 400/100 mg BID
Danish: Lopinavir/ritonavir 400/100 mg x 2
English: Gently empty Aptivus oral solution from the syringe into your child's mouth.
Danish: Den udtrukkede Aptivus-dosis sprøjtes med forsigtighed ind i munden på dit barn.
English: Tadalafil 10 mg QD Tadalafil first-dose Cmax ↓ 22% Tadalafil first-dose AUC ↑ 133%
Danish: Tadalafil første-dosis Cmax ↓ 22% Tadalafil første-dosis AUC ↑ 133%
English: The oral clearance of tipranavir decreased after the addition of ritonavir which may represent diminished first-pass clearance of the substance at the gastrointestinal tract as well as the liver.
Danish: Den orale clearance af tipranavir faldt efter tilførsel af ritonavir, hvilket kan skyldes nedsat first-passclearance af lægemidlet i mave/tarm-kanalen og leveren.
English: Metabolic profile of tipranavir
Danish: Tipranavirs metaboliske profil
English: You should therefore carefully read the Package Leaflets of ritonavir and your child's other antiretroviral medicines.
Danish: Du bør derfor læse indlægssedlerne for både ritonavir og for de andre antiretrovirale midler, som dit barn får.
English: Nucleoside analogue DNA polymerase inhibitors Valaciclovir 500 mg single dose
Danish: Nukleosidanalog-DNA-polymerasehæmmere Valaciclovir 500 mg éngangsdosis
English: Tell your doctor if you have: - type A or B haemophilia - diabetes - liver disease.
Danish: Fortæl det til lægen, hvis du har eller har haft nogen af nedenstående sygdomme eller tilstande: - blødersygdom, type A eller B - diabetes - leversygdom.
English: This score (counting the 16 amino acids that have been associated with reduced tipranavir susceptibility and/or reduced viral load response: 10V, 13V, 20M/R/V, 33F, 35G, 36I, 43T, 46L, 47V, 54A/M/V, 58E, 69K, 74P, 82L/T, 83D and 84V) was applied to baseline viral protease sequences.
Danish: Denne score (opgjort ved at tælle de 16 aminosyrer, der er forbundet med nedsat følsomhed over for tipranavir og/eller nedsat virusmængde-respons: 10V, 13V, 20M/R/V, 33F, 35G, 36I, 43T, 46L, 47V, 54A/M/V, 58E, 69K, 74P, 82L/T, 83D og 84V) blev anvendt ved baseline virusproteasesekvenser.
English: High density polyethylene (HDPE) bottle with two-piece child-resistant closure (outer and inner shell polypropylene, with a pulpboard/aluminium liner).
Danish: HDPE-beholder med dobbelt, børnesikret lukke (yderste og inderste skal polypropylen med et indlæg af træpap/aluminium).
English: Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase dihydroergotamine, ergonovine, ergotamine and methylergonovine concentrations.
Danish: Teoretisk forventes det, at tipranavir plus lavdosis ritonavir øger plasmakoncentrationerne af dihydroergotamin, ergonovin, ergotamin og methylergonovin.
English: No data are currently available on interactions of tipranavir, coadministered with low dose ritonavir, with protease inhibitors other than those listed above.
Danish: Der foreligger ingen data om interaktioner af tipranavir plus lavdosis ritonavir med proteasehæmmere ud over dem, der er nævnt ovenfor.
English: In the case of tipranavir co-administered with low dose ritonavir, concomitant use with rifampicin is expected to result in sub-optimal levels of tipranavir which may lead to loss of virologic response and possible resistance to tipranavir.
Danish: Samtidig behandling af rifampicin og tipranavir plus lavdosis ritonavir forventes, at give sub-optimale niveauer af tipranavir, hvilket kan resultere i tab af virologisk respons, og mulig resistensudvikling over for tipranavir.
English: Phenobarbital and phenytoin should be used with caution in combination with Aptivus, co-administered with low dose ritonavir (see section 4.4).
Danish: Der bør udvises forsigtighed ved brug af phenobarbital og phenytoin i kombination med Aptivus og lavdosis ritonavir (se pkt.
English: Fluconazole ↔ Tipranavir Cmax ↑ 32% Tipranavir AUC ↑ 50% Tipranavir Cmin ↑ 69% Mechanism unknown
Danish: Fluconazol ↔ Tipranavir Cmax ↑ 32% Tipranavir AUC ↑ 50% Tipranavir Cmin ↑ 69% Ukendt mekanisme.
English: The baseline characteristics and the key efficacy results at 48 weeks for the paediatric patients receiving Aptivus oral solution are displayed in the tables below.
Danish: I tabellerne nedenfor er angivet baseline-karakteristika og de vigtigste resultater ved uge 48 for de pædiatriske patienter, der modtog Aptivus oral opløsning.
English: Additionally, in one interaction trial, in healthy female volunteers administered a single dose of ethinyl oestradiol followed by Aptivus co-administered with low dose ritonavir, 33% of subjects developed a rash.
Danish: Desuden udviklede 33% af patienternene udslæt i et interaktionsstudie med kvindelige raske frivillige, der fik en enkelt dosis ethinylestradiol efterfulgt af Aptivus plus lavdosis ritonavir.
English: Quinidine No interaction study performed
Danish: Quinidin Der er ikke udført interaktionsstudier.
English: Your child must take Aptivus in combination with low dose ritonavir and other antiretroviral medicines.
Danish: Dit barn skal tage Aptivus sammen med lavdosis ritonavir og andre antiretrovirale midler.
English: Fusion inhibitors Enfuvirtide No interaction study performed
Danish: Fusionshæmmere Enfuvirtid Der er ikke udført interaktionsstudier
English: A cocktail study was conducted in 16 healthy volunteers with twice-daily tipranavir 500 mg with ritonavir 200 mg capsule administration for 10 days to assess the net effect on the activity of hepatic CYP 1A2 (caffeine), 2C9 (warfarin), 2D6 (dextromethorphan), both intestinal/hepatic CYP 3A4 (midazolam) and P-glycoprotein (P-gp) (digoxin).
Danish: Der blev udført et studie med en cocktail af forskellige lægemidler på 16 raske frivillige patienter, som fik 500 mg tipranavir med 200 mg ritonavir kapsler to gange dagligt i 10 dage for at bestemme nettoeffekten på aktiviteten af hepatisk CYP1 A2 (koffein), 2C9 (warfarin), og 2D6 (dextromethorfan), begge intestinal/hepatisk CYP3A4 (midazolam) og P-glykoprotein (P-gp) (digoxin).
English: Before giving Aptivus you should check that the oral solution is clear.
Danish: Før Aptivus oral opløsning doseres skal det tjekkes, om opløsningen er klar.
English: You should not use Aptivusif you have never received antiretroviral therapy or have other antiretroviral options available.
Danish: Aptivus skal ikke ordineres til dig, hvis du ikke tidligere har fået antiretroviral behandling, eller hvis anden antiretroviral behandling kan bruges.
English: Through a series of multiple stepwise regression analyses of baseline and on-treatment genotypes from all clinical studies, 16 amino acids have been associated with reduced tipranavir susceptibility and/or reduced 48-week viral load response: 10V, 13V, 20M/R/V, 33F, 35G, 36I, 43T, 46L, 47V, 54A/M/V, 58E, 69K, 74P, 82L/T, 83D and 84V.
Danish: Ved baseline og under behandlingen i kliniske studier har man gennem en serie multiple, trinvise regressionsanalyser af genotyper sat 16 aminosyrer i forbindelse med nedsat tipranavir-følsomhed og/eller nedsat 48-ugers viralt belastningsrespons: 10V, 13V, 20M/R/V, 33F, 35G, 36I, 43T, 46L, 47V, 54A/M/V, 58E, 69K, 74P, 82L/T, 83D og 84V.
English: Metabolism and nutrition disorders common hypertriglyceridaemia, hyperlipidaemia uncommon anorexia, decreased appetite, weight decreased, hyperamylasaemia, hypercholesterolaemia, diabetes mellitus, hyperglycaemia rare dehydration
Danish: Ikke almindelig anoreksi, nedsat appetit, vægttab, hyperamylasæmi, hyperkolesterolæmi, diabetes mellitus, hyperglykæmi
English: Also, appropriate dose adjustments for children under 12 years cannot be achieved with Aptivus capsules.
Danish: En passende dosisjustering af Aptivus kapsler til børn under 12 år er ikke mulig.
English: Aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options (see sections 4.4 and 5.1).
Danish: Aptivus bør kun anvendes i kombinationsbehandling med antiretroviale lægemidler hos patienter, hvor der ikke er nogen anden terapeutisk mulighed (se pkt.
English: Since currently only limited efficacy and safety data are available for adolescents (see section 5.1) close monitoring of virologic response and tolerance is particularly warranted in this patient group.
Danish: Tæt monitorering af patientens virologiske respons og tolerance er særligt påkrævet hos unge patienter, da der er begrænset data for sikkerhed og virkning for denne patientgruppe (se pkt.
English: The baseline characteristics and the key efficacy results at 48 weeks for the paediatric patients receiving Aptivus capsules are displayed in the tables below.
Danish: I tabellerne nedenfor er angivet baseline-karakteristika og de vigtigste resultater ved uge 48 for de pædiatriske patienter, der modtog Aptivus kapsler.
English: Tipranavir adversely interacts with oral contraceptives.
Danish: Interaktionen mellem tipranavir og orale antikonceptionsmidler er ugunstig.
English: After baseline and placebo adjustment, the maximum mean QTcF change was 3.2 ms (1-sided 95% Upper CI: 5.6 ms) for the 500/200 mg dose and 8.3 ms (1-sided 95% Upper CI: 10.8 ms) for the supra-therapeutic 750/200 mg dose.
Danish: Efter justering for baseline og placebo var den maksimale gennemsnitlige ændring af QTcF 3,2 ms (ensidet 95 % CI øvre grænse: 5,6 ms) for 500/200 mg dosen og 8,3 ms (ensidet 95 % CI øvre grænse: 10,8 ms) for den supraterapeutiske dosis på 750/200 mg. QTc-intervallet blev således ikke forlænget ved terapeutiske doser af tipranavir plus lavdosis ritonavir, men kan blive forlænget ved supraterapeutiske doser.
English: What Aptivus contains - The active substance is tipranavir.
Danish: Aptivus indeholder: - Aktivt stof: Tipranavir.
English: Mint and Butter Toffee flavourings.
Danish: Butter toffee (aroma)
English: Coadministration of Aptivus with ritonavir, with St. John's wort is expected to substantially decrease tipranavir and ritonavir concentrations and may result in sub-optimal levels of tipranavir and lead to loss of virologic response and possible resistance to tipranavir.
Danish: Aptivus med ritonavir plus perikon forventes at give et væsentlig koncentrationsfald af tipranavir og ritonavir, der kan resultere i suboptimale niveauer af tipranavir og fører til tab af virologisk respons og mulig resistens over for tipranavir.
English: The safety and efficacy of Aptivus in children under 2 years of age has not been established.
Danish: Aptivus's sikkerhed og virkning hos børn under 2 år er ikke klarlagt.
English: Digoxin 0.25 mg QD iv
Danish: Digoxin 0,25 mg x 1 i.v.
English: Each capsule contains 250 mg tipranavir.
Danish: En kapsel indeholder 250 mg tipranavir.
English: Blood and lymphatic system disorders uncommon neutropenia, anaemia, thrombocytopenia
Danish: Ikke almindelig neutropeni, anæmi, trombocytopeni
English: Warnings and precautions Talk to your doctor or pharmacist before taking Aptivus.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Aptivus.
English: In general, adverse reactions were similar to those seen in adults, with the exception of vomiting, rash and pyrexia which were reported more frequently in children than in adults.
Danish: Generelt var bivirkningerne de samme, som dem der er set hos voksne med undtagelse af opkastning, udslæt og feber, som var hyppigere hos børn.
English: In a study performed in antiretroviral naïve adult patients, tipranavir 500 mg with ritonavir 200 mg twice daily, as compared to lopinavir/ritonavir, was associated with an excess in the occurrence of significant (grade 3 and 4) transaminase elevations without any advantage in terms of efficacy (trend towards a lower efficacy).
Danish: I et studie med voksne antiretroviral-naive patienter, blev 500 mg tipranavir med 200 mg ritonavir givet to gange dagligt, associeret med en øget forekomst af signifikant aminotransferaseforhøjelse (grad 3 og 4) sammenlignet med lopinavir/ritonavir.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany.
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Boehringer Ingelheim Pharma GmbH & Co.
English: Sertindole Quetiapine Lurasidone No interaction study performed
Danish: Sertindol Quetiapin Lurasidon Der er ikke udført interaktionsstudier.
English: Baseline % CD4+ cells Median (Min - Max)
Danish: Baseline % CD4+ celler
English: The concomitant use of Aptivus, co-administered with low dose ritonavir, with simvastatin or lovastatin are contra-indicated due to an increased risk of myopathy, including rhabdomyolysis (see section 4.3).
Danish: Samtidig anvendelse af Aptivus sammen med lavdosis ritonavir og simvastatin eller lovastatin er kontraindiceret pga. øget risiko for myopati herunder rabdomyolyse (se pkt.