FrancophonIA/ELRC3.0 huggingface dataset:
English: *Historical data from the thorough QT study conducted in healthy volunteers
Danish: *Tidligere data fra det grundige QT-studiet udført med raske frivillige.
English: 20 hours
Danish: 20 timer
English: • electrolyte disturbances, particularly uncorrected hypokalaemia
Danish: • elektrolytforstyrrelser, især ukorrigeret hypokaliæmi
English: Vasodilators (peripheral) Vincamine i.v.
Danish: Vasodilatorer (periferale) Vincamin i.v.
English: Do not take a double dose to make up for a forgotten individual dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte enkeltdosis.
English: It is for the treatment of infection with the human immunodeficiency virus (HIV).
Danish: Det anvendes til behandling af infektion med det humane immundefekt virus (hiv).
English: Distribution studies in these species showed that the placental transfer of saquinavir is low (less than 5% of maternal plasma concentrations).
Danish: Distributionsstudier i disse arter viste at placentaoverførslen af saquinavir er lav (mindre end 5 % af maternelle plasmakoncentrationer).
English: Adverse reactions are presented according to the MedDRA system organ classification.
Danish: Bivirkninger er præsenteret i henhold til MedDRA-systemorganklasser.
English: Diabetes mellitus, anorexia, increased appetite
Danish: Diabetes mellitus, anoreksi, øget appetit
English: If you notice any symptoms of infection, please inform your doctor immediately (see Section 4).
Danish: Hvis du bemærker nogen som helst symptomer på infektion, skal du omgående informere din læge (se afsnit 4).
English: There are certain conditions, which you may have, or have had, which require special care before or while taking Invirase/ritonavir.
Danish: Der er visse tilstande, som du kan lide af eller have haft, som gør det nødvendigt at tage særlige forholdsregler før eller medens du tager Invirase/ritonavir.
English: The serum concentration of digoxin should be monitored and a dose reduction of digoxin should be considered if necessary.
Danish: Serumkoncentrationen af digoxin skal overvåges, og om nødvendigt bør det overvejes at reducere digoxindosis.
English: When treating HIV infection it is not always possible to differentiate between unwanted effects caused by Invirase or by any other medicines you take at the same time or by the complications of the infection.
Danish: Når man behandler hiv-infektion er det ikke altid muligt at skelne imellem uønskede virkninger forårsaget af Invirase, eller forårsaget af anden medicin du indtager samtidig, eller af infektionens komplikationer.
English: • clinically relevant bradycardia
Danish: • klinisk relevant bradykardi
English: This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
Danish: Denne indlægsseddel findes på alle EU-/EØS-sprog på det Europæiske Lægemiddelagenturs hjemmeside.
English: Any of these other medicines:
Danish: Nogen af nedenstående lægemidler:
English: Caution is warranted and clinical monitoring of patients is recommended.
Danish: Forsigtighed er påkrævet og klinisk monitorering af patienterne anbefales.
English: Appropriate doses of combination not established.
Danish: Hensigtsmæssige doser af kombinationen er ikke fastsat.
English: Also, changes in laboratory markers (e.g., blood or urine tests) have been reported very commonly.
Danish: Ændringer i laboratorieværdier (f.eks. blod- og urinundersøgelser) er også meget almindeligt rapporteret.
English: Adults over 60 years: The experience with Invirase in adults over 60 years is limited.
Danish: Voksne over 60 år: Erfaring med Invirase hos voksne over 60 år er begrænset.
English: If signs or symptoms suggesting cardiac arrhythmia occur, continuous monitoring of ECG should be performed.
Danish: Hvis der forekommer tegn eller symptomer, som tyder på hjertearytmier, bør ekg-monitorering udføres løbende.
English: ΔQTcFdense ms (SD)
Danish: ΔQTcFgennemsnit ms (SD)
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Danish: Selvom effektiv viral suppression med antiretroviral behandling er vist at nedsætte risikoen for seksuel overførsel væsentligt, kan en residual risiko ikke udelukkes.
English: Carcinogenesis: There was no evidence of carcinogenic activity after the administration of saquinavir mesilate for 96 to 104 weeks to rats and mice.
Danish: Karcinogenicitet: Der var ingen tegn på Karcinogen aktivitet efter indgift af saquinavirmesilat i 96 til 104 uger t rotter og mus.
English: Invirase is contraindicated in patients with:
Danish: Invirase er kontraindiceret hos patienter med:
English: Digoxin levels may differ over time.
Danish: Digoxinkoncentrationen kan ændre sig over tid.
English: On Day 3 of dosing, ECG measurements were done over a period of 20 hours.
Danish: På dag 3 efter doseringsstart blev ekg-målinger udført over en 20 timers periode.
English: Titanium dioxide (E 171), Talc,
Danish: Titandioxid (E 171) Talcum
English: INFORMATION IN BRAILLE invirase 500 mg
Danish: INFORMATION I BRAILLE-SKRIFT invirase 500 mg
English: Results are based on total concentrations (protein-bound and unbound).
Danish: Resultaterne er baseret på totale koncentrationer (proteinbundet og ubundet).
English: Cmin = the observed plasma concentration at the end of the dose interval.
Danish: Cmin = de observerede plasmakoncentrationer ved slutningen af dosisintervallet.
English: It has been shown that saquinavir is approximately 97 % bound to plasma proteins up to 30 µg/ml.
Danish: Det er vist, at saquinavir er ca. 97 % bundet til plasmaproteiner op til 30 µg/ml.
English: Treatment of overdose with saquinavir should consist of general supportive measures, including monitoring of vital signs and ECG, and observations of the patient's clinical status.
Danish: Behandlingen for overdosering med saquinavir bør bestå af generel støttende behandling, herunder overvågning af vitale tegn og ekg, samt observationer af patientens kliniske situation.
English: Limited data from controlled clinical studies with the approved dosage regimen do not indicate a major difference in the efficacy and safety profile between men and women.
Danish: Begrænsede data fra kontrollerede kliniske studier med godkendte doseringsregimer indikerer ikke en større forskel mellem effekt og sikkerhedsprofilerne for mænd og kvinder.
English: No clinically significant interaction was noted.
Danish: Der er ikke set klinisk signifikant interaktion.
English: Paediatric Patients: Steady state pharmacokinetic information is available from HIV-infected paediatric patients from study NV20911.
Danish: Pædiatriske patienter: Steady state farmakokinetisk information er tilgængelig fra hiv-inficerede pædiatriske patienter fra studie NV20911.
English: TQT Study Day 3* (n=57)
Danish: TQT Studie Dag 3* (n=57)
English: - Physicians should enquire about any known familial history of sudden death at a young age as this may be suggestive of congenital QT prolongation.
Danish: - Lægen skal forhøre sig om ethvert tilfælde af pludselig død i en ung alder i familieanemnesen, da dette kan være tegn på medfødt QT-forlængelse.
English: Decreased libido, sleep disorder
Danish: Nedsat libido, søvnforstyrrelser
English: In combination with ritonavir
Danish: I kombination med ritonavir
English: In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
Danish: I flere end halvdelen af de meddelte tilfælde fortsattes behandlingen med proteasehæmmere eller behandlingen blev genoptaget, hvis behandlingen var seponeret.
English: Clinical results from paediatric studies
Danish: Kliniske resultater fra pædiatriske studier
English: The presence of 3 or more mutations was associated with reduced response to saquinavir/ritonavir.
Danish: Tilstedeværelse af 3 eller flere mutationer var forbundet med nedsat respons af saquinavir/ritonavir.
English: The low bioavailability is thought to be due to a combination of incomplete absorption and extensive firstpass metabolism.
Danish: Den lave biotilgængelighed menes at skyldes en kombination af ufuldstændig absorption og udtalt first pass metabolisme.
English: Should this happen to you, seek immediate advice from your doctor.
Danish: Skulle dette ske for dig, bør du øjeblikkelig kontakte din læge.
English: Ask your doctor or pharmacist for more information about taking Invirase/ritonavir with other medicines.
Danish: Bed din læge eller apoteket om flere oplysninger om, hvordan Invirase/ritonavir skal indtages sammen med andre lægemidler.
English: The Day 3 timepoint was chosen since the pharmacokinetic exposure was maximum on that day in a previous 14-day multiple dose pharmacokinetic study.
Danish: Dag 3 tidspunktet blev valgt, fordi den farmakokinetiske eksponering i et tidligere 14-dages flerdosis farmakokinetisk studie var maksimal på denne dag.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ (E) Oral anvendelse
English: Clinical results from studies with treatment naïve and experienced patients
Danish: Kliniske resultater fra studier med naive og tidligere behandlede patienter
English: Concentrations unbound at steady-state were not assessed.
Danish: Koncentrationerne af ubundet ved steady state blev ikke vurderet.
English: There is limited experience of overdose with saquinavir.
Danish: Der er begrænset erfaring med overdosering med saquinavir.
English: If you forget to take one dose, take this dose as soon as you remember together with some food.
Danish: Hvis du glemmer at indtage en dosis skal du indtage dosis sammen med føde så snart du kommer i tanke om det.
English: Increase not thought to be clinically relevant.
Danish: Stigning anses ikke for at være klinisk relevant.
English: Medicinal product by therapeutic area (dose of Invirase used in study)
Danish: Lægemidler opdelt efter terapeutisk område (dosering af Invirase anvendt i studie)
English: The frequency groupings according to MedDRA convention are: Very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).
Danish: Frekvenserne er inddelt i henhold til MedDRA på følgende måde: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (frekvens kan ikke estimeres ud fra tilgængelige data).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsenvia det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: These events were vomiting (3 patients), abdominal pain (1 patient) and diarrhoea (1 patient).
Danish: Disse bivirkninger var opkastning (3 patienter), abdominalsmerter (1 patient) og diarré (1 patient).
English: Alprazolam Clorazepate Diazepam
Danish: Alprazolam Clorazepat Diazepam
English: Increased concentrations of indinavir may result in nephrolithiasis.
Danish: Øgede koncentrationer af indinavir kan resultere i nephrolithiasis.
English: Also included are serious and non-serious adverse reactions from post-marketing spontaneous reports for which a causal relationship to saquinavir cannot be excluded.
Danish: Tabellen inkluderer også alvorlige og ikke-alvorlige bivirkninger fra spontane rapporter efter markedsføring, hvor en kausal sammenhæng med saquinavir ikke kan udelukkes.
English: Mechanism of action: The HIV protease is an essential viral enzyme required for the specific cleavage of viral gag and gag-pol polyproteins.
Danish: Virkningsmekanisme: Hiv-protease er et essentielt viralt enzym, der er nødvendigt for den specifikke spaltning af virale gag og gag-pol polyproteiner.
English: • certain medicines used to prevent rejection of new organs after a transplant operation such as tacrolimus
Danish: • visse lægemidler som bruges til at forhindre afstødning af nye organer efter en organtransplantation, såsom tacrolimus
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indbrette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V
English: PR intervals of > 200 msec were seen in 3% of subjects in the active control group (moxifloxacin) and 5% in the placebo arm.
Danish: PR-intervaller på > 200 ms blev set hos 3 % af forsøgspersonerne i den aktive kontrolgruppe (moxifloxacin) og hos 5 % i placebo-armen.
English: The CD4 lymphocyte count expressed as percentage mean CD4 increased by a mean of 2.97% over the same 48 week period.
Danish: CD4-lymfocyt-tallet (udtrykt som gennemsnitlig CD4 i procent) steg med gennemsnitlig 2,97 % i løbet af den samme 48 ugers periode.
English: The infants and young children were stratified into 2 groups: Group A “Low Age Group” 4 months to less than 2 years old (n=5) and Group B “High Age Group” children 2 years to less than 6 years old (n=13).
Danish: Spædbørnene og de små børn blev stratificeret til 2 grupper: Gruppe A ”Yngre aldersgruppe” børn i alderen fra 4 måneder til yngre end 2 år (n=5 og gruppe B ”Ældre aldersgruppe” børn i alderen fra 2 år til yngre end 6 år (n=13).
English: This is partly linked to restored health and lifestyle, and in the case of blood lipids sometimes to the HIV medicines themselves.
Danish: Dette er til dels forbundet med forbedret helbredstilstand og med livsstil, og for lipidernes vedkommende sommetider med selve hiv-medicinen.
English: No pharmacokinetic interaction studies have been completed.
Danish: - Der er ikke udført farmakokinetiske interaktionsstudier.
English: The proportion of patients with a reported PR interval prolongation > 200 ms in this study ranged from 3/22 (14%) (day 3) to 8/21 (38%) (day14).
Danish: Andelen af patienter med en rapporteret forlængelse af PRintervallet > 200 ms i dette studie spændte fra 3/22 (14 %) (dag 3) til 8/21 (38 %) (dag 14).
English: High doses of ketoconazole (> 200 mg/day) are not recommended.
Danish: Høje doser af ketoconazol (> 200 mg/dag) anbefales ikke.
English: Invirase is not recommended for use in combination with cobicistat as dosing recommendations for this combination have not been established.
Danish: Det anbefales ikke at bruge Invirase i kombination med cobicistat, da doseringsanbefalinger for denne kombination ikke er fastslået.
English: Pregnancy: Evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the development of the embryo or foetus, the course of gestation and peri- and post-natal development.
Danish: Graviditet: Vurdering af eksperimentelle dyrestudier indicerer ikke nogle direkte eller indirekte skadelige virkninger med hensyn til udviklingen af embryonet eller fostret, forløbet af svangerskabet og den peri- eller postnatale udvikling.
English: An updated RMP should be submitted: - At the request of the European Medicines Agency; - Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: En opdateret RMP skal fremsendes: på anmodning fra Det Europæiske Lægemiddelagentur når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: • clinically relevant heart failure with reduced left-ventricular ejection fraction
Danish: • klinisk relevant hjerteinsufficiens med nedsat ejektionsfraktion fra venstre ventrikel
English: Dose adjustment of bosentan may be required.
Danish: Dosisjustering af bosentan kan være nødvendig.
English: The film-coated tablets should be swallowed whole Read the package leaflet before use
Danish: De filmovertrukne tabletter skal synkes hele Læs indlægssedlen inden brug
English: At present, there is only limited information on the use of Invirase/ritonavir in children and in adults over the age of 60 years.
Danish: På nuværende tidspunkt findes der kun begrænset dokumentation for behandling med Invirase/ritonavir hos børn og hos voksne over 60 år.
English: Careful monitoring of patients with regard to sedative effects is warranted.
Danish: Det anbefales at monitorere patienterne omhyggeligt med hensyn til sedativ effekt.
English: Therefore, before taking this medicine, you should have told your doctor if you suffer from diarrhoea, or if you have allergies (see Section 4) or if you have an intolerance to some sugars (see section “Invirase contains lactose”).
Danish: Før du begynder at tage denne medicin, skal du fortælle din læge, hvis du har diarré eller allergier (se afsnit 4), eller hvis du ikke kan tåle visse sukkerarter (se afsnit “Invirase indeholder lactose”).
English: • lurasidone - used to treat schizophrenia.
Danish: • lurasidon - bruges til at behandle skizofreni
English: The G48V mutation, previously identified in vitro as a saquinavir signature mutation, was present at baseline in virus from three patients, none of whom responded to therapy.
Danish: G48V-mutationen, som tidligere er blevet identificeret in vitro som saquinavirs signaturmutation, var til stede ved baseline i virus fra tre patienter, som ikke reagerede på behandlingen.
English: Date of latest renewal: 04 October 2006
Danish: Dato for første markedsføringstilladelse: 4. oktober 1996 Dato for seneste fornyelse: 4. oktober 2006
English: Saquinavir selectively inhibits the HIV protease, thereby preventing the creation of mature infectious virus particles.
Danish: Saquinavir hæmmer selektivt hiv-proteasen, hvorved dannelsen af modne, infektiøse viruspartikler forhindres.
English: The combination of Invirase/ritonavir with drugs known to increase the exposure of saquinavir is not recommended and should be avoided when alternative treatment options are available.
Danish: Kombination af Invirase/ritonavir med lægemidler kendt for at øge eksponeringen af saquinavir anbefales ikke og bør undgås, hvis der findes alternative behandlingsmuligheder.
English: While the supra-therapeutic dose of Invirase/ritonavir appeared to have a greater effect on the QT interval than the therapeutic dose of Invirase/ritonavir, it is not sure if maximum effect for both doses has been observed.
Danish: Mens den supraterapeutiske dosis af Invirase/ritonavir syntes at have en større effekt på QT-intervallet end den terapeutiske dosis af Invirase/ritonavir, er det ikke sikkert, hvorvidt der for begge doser er observeret maksimal effekt.
English: If no alternative treatment is available, use with careful monitoring (see section
Danish: Hvis ingen alternative behandlingsmuligheder er tilgængelige, skal de anvendes med omhyggelig monitorering (se pkt.
English: Antiviral activity according to baseline genotype and phenotype:
Danish: Antiviral aktivitet i henhold til baseline-genotype og fænotype:
English: Events of syncope/presyncope occurred at a higher than expected rate and were seen more frequently under treatment with saquinavir (11 of 13).
Danish: Tilfælde af synkope/præsynkope forekom oftere end forventet og blev set hyppigere under behandling med saquinavir (11 af 13).
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Danish: Hvis det kan påvises at leversygdommen forværres, bør afbrydelse eller stop af behandlingen overvejes.
English: Baseline saquinavir phenotype (shift in susceptibility relative to reference, PhenoSense Assay) was shown to be a predictive factor of virological outcome.
Danish: Saquinavir-fænotype ved baseline (skift i følsomhed i forhold til reference, PhenoSense Assay) har vist sig at være en forudsigelig faktor for virologisk resultat.
English: Patients on saquinavir treatment must not take garlic capsules due to the risk of decreased plasma concentrations and loss of virological response and possible resistance to one or more components of the antiretroviral regimen.
Danish: Patienter i saquinavirbehandling må ikke indtage hvidløgskapsler på grund af risikoen for fald i plasmakoncentration og tab af virologisk respons samt mulig resistens over for en eller flere af komponenterne i den antiretrovirale regime.
English: There are some medications that must not be taken with Invirase/ritonavir (see section "Do not take Invirase if you are taking any of the following medicines:" above).
Danish: Der er nogle lægemidler, som ikke må indtages sammen med Invirase/ritonavir (se afsnit ”Tag ikke Invirase hvis du tager nogen af følgende lægemidler” ovenfor).
English: Medicines that can interact with saquinavir or ritonavir include:
Danish: Lægemidler, som kan interagere med saquinavir og/eller ritonavir omfatter:
English: Do not take Invirase if you have:
Danish: Tag ikke Invirase:
English: Use of unboosted saquinavir with zalcitabine and/or zidovudine has been studied in adults.
Danish: - Brug af ikke-boostet saquinavir med zalcitabin og/eller zidovudin er blevet undersøgt hos voksne.
English: Acute and chronic toxicity: Saquinavir was well tolerated in oral acute and chronic toxicity studies in mice, rats, dogs and marmosets.
Danish: Akut og kronisk toksicitet: Saquinavir blev udmærket tolereret i orale akutte og kroniske toksicitetsstudier på mus, rotter, hunde og silkeaber.
English: In case of withdrawal of glucocorticoids progressive dose reduction may have to be performed over a longer period.
Danish: Ved seponering af glukokortikoider kan det være nødvendigt at nedtrappe behandlingen gradvist over en længere periode.
English: There is no specific antidote for overdose with saquinavir.
Danish: Der findes ingen specifik antidot mod overdosering med saquinavir.
English: Immunosuppressants Tacrolimus
Danish: Immunosuppressiva Tacrolimus
English: Monitoring of the patient's HIV therapy is also recommended.
Danish: Der anbefales også at monitorere patientens hivbehandling.
English: Invirase contains the active substance saquinavir which is an antiviral agent.
Danish: Invirase indeholder det aktive stof saquinavir, der er et antiviralt stof.
English: Therapy with Invirase should be initiated by a physician experienced in the management of HIV infection.
Danish: Dosering Behandling med Invirase bør påbegyndes af en læge med erfaring i behandling af hiv-infektion.
English: See table 1, section 4.5, for drugs known and/or having the potential to interact with saquinavir and specific recommendations.
Danish: 4.5, tabel 1 for de lægemidler, der er kendt for, og/eller som har potentiale for, at interagere med saquinavir, , samt specifikke anbefalinger.
English: ECG and PK measurements were collected on Days 3, 4, 7, 10, and 14 of treatment with the modified Invirase/ritonavir treatment.
Danish: Ekg og farmakokinetiske data blev indsamlet på dag 3, 4, 7, 10 og 14 i behandlingen med den modificerede Invirase/ritonavir-behandling.
English: • Take Invirase at the same time as your ritonavir (Norvir) capsules.
Danish: • Tag Invirase samtidig med dine ritonavir (Norvir) kapsler
English: Do not take Invirase with any other drug unless you have talked to your doctor first.
Danish: Du må ikke tage Invirase sammen med andre lægemidler uden først at have talt med din læge.
English: Since the magnitude of QT and PR prolongation increases with increasing concentrations of saquinavir, the recommended dose of ritonavir-boosted Invirase should not be exceeded.
Danish: Da QT- og PR-forlængelsen øges med stigende koncentrationer af saquinavir, bør den anbefalede dosis af ritonavirboostet Invirase ikke overskrides.