natgillin/translations-raw huggingface dataset:
APTIVUS bør ikke anvendes til børn p. g. a. utilstrækkelig dokumentation for sikkerhed og virkning.
APTIVUS is not recommended for use in children due to insufficient data on safety and efficacy.
Kliniske forsøg med APTIVUS omfattede ikke et tilstrækkeligt antal forsøgspersoner på 65 år eller mere til at kunne vurdere, om de responderer anderledes end yngre patienter.
Clinical studies of APTIVUS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects (see section 5.2).
5. 2).
APTIVUS soft capsules co-administered with low dose ritonavir should be taken with food (see section 5.2).
Leverinsufficiens:
Liver impairment:
APTIVUS bør derfor anvendes med forsigtighed og med øget monitoreringsfrekvens hos patienter med mild leverinsufficiens (Child- Pugh A).
Therefore, APTIVUS should be used with caution, and with increased monitoring frequency, in patients with mild hepatic impairment (Child- Pugh Class A).
4. 3, 4. 4 og 5. 2).
APTIVUS should not be used in patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) (see sections 4.3, 4.4 and 5.2).
Nyreinsufficiens:
Renal impairment:
4. 4 og 5. 2).
No dosage adjustment is required in patients with renal impairment (see sections 4.4 and 5.2).
Patienter med moderat til svær leverinsufficiens (Child- Pugh B eller C).
Patients with moderate or severe (Child-Pugh B or C) hepatic impairment.
4. 5).
Combination of rifampicin with APTIVUS with concomitant low dose ritonavir is contraindicated (see section 4.5).
4. 5).
Herbal preparations containing St John’ s wort (Hypericum perforatum) must not be used while taking APTIVUS due to the risk of decreased plasma concentrations and reduced clinical effects of tipranavir (see section 4.5).
Samtidig behandling med APTIVUS plus lavdosis ritonavir og aktive substanser, der nedbrydes via CYP3A, og hvor forhøjede plasmakoncentrationer medfører alvorlige og/ eller livstruende hændelser, er kontraindiceret.
Co-administration of APTIVUS with low dose ritonavir, with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/ or life-threatening events is contraindicated.
Disse aktive substanser omfatter antiarytmika (amiodaron, bepridil, quinidin), antihistaminer (astemizol, terfenadin), ergot- derivater (dihydroergotamin, ergonovin, ergotamin, metylergonovin), motilitetsfremmende midler til gastrointestinal- kanalen (cisaprid), neuroleptika (pimozid, sertindol), sedativer/ hypnotika (peroralt administreret midazolam og triazolam.
These active substances include antiarrhythmics (amiodarone, bepridil, quinidine), antihistamines (astemizole, terfenadine), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/ hypnotics (orally administered midazolam and triazolam.
4. 5) og HMG- CoA reduktasehæmmere (simvastatin og lovastatin).
For caution on parenterally administered midazolam see section 4.5) and HMG-CoA reductase inhibitors (simvastatin and lovastatin).
4. 2).
APTIVUS must be administered with low dose ritonavir to ensure its therapeutic effect (see section 4.2).
Hvis tipranavir og ritonavir ikke gives korrekt sammen, resulterer det i nedsatte plasmaniveauer for tipranavir, som kan være utilstrækkelige til at opnå den ønskede antivirale effekt.
Failure to correctly co-administer tipranavir with ritonavir will result in reduced plasma levels of tipranavir that may be insufficient to achieve the desired antiviral effect.
Der bør ikke ordineres ritonavir i doser mindre end 200 mg to gange daglig da det kan ændre effekt - profilen ved kombinationsbehandlingen.
Doses of ritonavir lower than 200 mg twice daily should not be used as they might alter the efficacy profile of the combination.
3 APTIVUS helbreder ikke HIV- 1- infektion eller AIDS.
3 APTIVUS is not a cure for HIV-1 infection or AIDS.
Patienter, der får APTIVUS eller enhver anden antiretroviral- behandling kan fortsat få opportunistiske infektioner og andre komplikationer til HIV- 1 - infektion.
Patients receiving APTIVUS or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV-1 infection.
Patienterne skal vejledes om, at det ikke er vist, at den nuværende antiretrovirale- behandling kan forhindre risikoen for at overføre hiv til andre via blod eller seksuel kontakt.
Patients should be advised that current antiretroviral therapy has not been proven to prevent the risk of transmission of HIV to others through blood or sexual contact.
Der skal stadig tages relevante forholdsregler.
Appropriate precautions should continue to be employed.
Generelt skal der udvises forsigtighed, når der gives APTIVUS til ældre patienter, pga. den højere frekvens af nedsat lever -, nyre - og hjertefunktion, og andre sygdomme eller anden behandling.
In general, caution should be exercised in the administration and monitoring of APTIVUS in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other therapy.
Leversygdom:
Liver Disease:
APTIVUS er kontraindiceret til patienter med moderat eller svær leverinsufficiens (Child- Pugh B eller C).
APTIVUS is contraindicated in patients with moderate or severe (Child-Pugh Class B or C) hepatic insufficiency.
Der foreligger på nuværende tidspunkt begrænsede data vedrørende brugen af APTIVUS givet sammen med lavdosis ritonavir til patienter smittede med hepatitis B eller C.
Limited data are currently available for the use of APTIVUS, co- administered with low dose ritonavir, in patients co-infected with hepatitis B or C.
Patienter med kronisk hepatitis B eller C, som behandles med antiretroviral kombinationsbehandling, har øget risiko for svære og potentielt fatale leverbivirkninger.
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse events.
APTIVUS bør kun anvendes til denne patientpopulation, hvis den potentielle fordel opvejer den potentielle risiko, og med øget klinisk monitorering og laboratoriemonitorering.
APTIVUS should be used in this patient population only if the potential benefit outweighs the potential risk, and with increased clinical and laboratory monitoring.
Hvis der samtidig gives antiviral- behandling pga. hepatitis B eller C henvises til de pågældende produktresuméer for disse lægemidler.
In the case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Patienter med mild leverinsufficiens (Child- Pugh A) bør monitoreres nøje.
Patients with mild hepatic impairment (Child-Pugh Class A) should be closely monitored.
Patienter med leverdysfunktion inkl. kronisk aktiv hepatitis har en øget forekomst af leverfunktionsabnormiteter ved kombinationsbehandling og bør monitoreres iht almindelig praksis.
Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination therapy and should be monitored according to standard practice.
Behandlingen med APTIVUS/ ritonavir bør afbrydes, hvis der ses tegn på forværring af leverfunktionen hos patienter, der tidligere har fået diagnosticeret en leversygdom.
APTIVUS/ ritonavir should be discontinued once signs of worsening liver function occur in patients with pre-existing liver disease.
APTIVUS givet sammen med lavdosis ritonavir har været kodet sammen med rapporter om klinisk hepatitis og hepatisk dekompensering inkl. med dødelig udgang.
APTIVUS co-administered with low dose ritonavir, has been associated with reports of clinical hepatitis and hepatic decompensation, including some fatalities.
Disse tilfælde er generelt forekommet hos patienter med fremskreden HIV- sygdom og i multi- medicinsk behandling.
These have generally occurred in patients with advanced HIV disease taking multiple concomitant medicinal products.
Der skal udvises forsigtighed, når der gives APTIVUS/ ritonavir til patienter med abnorme leverenzymer eller tidligere hepatitis.
Caution should be exercised when administering APTIVUS, to patients with liver enzyme abnormalities or history of hepatitis.
Det skal overvejes at øge monitorering af ALAT/ ASAT hos disse patienter.
Increased ALAT/ ASAT monitoring should be considered in these patients.
Behandling med APTIVUS bør ikke initieres hos patienter, der før behandlingen har ASAT - eller ALAT- værdier, som er mere end 5 gange ULN (Upper Limit Normal), før ASAT/ ALAT ved baseline er stabiliseret til mindre end 5 gange ULN, medmindre den potentielle fordel opvejer den potentielle risiko.
APTIVUS therapy should not be initiated in patients with pre-treatment ASAT or ALAT greater than 5 times the Upper Limit Normal (ULN) until baseline ASAT/ ALAT is stabilised at less than 5X ULN, unless the potential benefit justifies the potential risk.
Behandling med APTIVUS bør derfor seponeres hos patienter, der får forhøjede værdier af ASAT eller ALAT på mere end 10 gange ULN, eller som udvikler tegn eller symptomer på klinisk hepatitis under behandlingen.
APTIVUS therapy should be discontinued in patients experiencing ASAT or ALAT elevations greater than 10X ULN, or developing signs or symptoms of clinical hepatitis during therapy.
Såfremt der identificeres en anden årsag (f. eks. akut hepatitis A, B eller C virus, sygdom i galdeblæren eller anden medicin), kan det overvejes om behandlingen med APTIVUS skal genoptages, når patientens ASAT/ ALAT værdier er på samme niveau som før behandlingen startede.
If another cause is identified (eg acute hepatitis A, B or C virus, gallbladder disease, other medicinal products), then rechallenge with APTIVUS may be considered when ASAT/ ALAT have returned to the patient ’ s baseline levels.
Levermonitorering:
Liver monitoring:
Monitorering af levertests bør ske før initiering af behandling, efter to og fire uger og sidenhen hver fjerde uge indtil 24. uge og derefter hver ottende til tolvte uge.
Monitoring of hepatic tests should be done prior to initiation of therapy, after two, four and then every four weeks until 24 weeks, and then every eight to twelve weeks thereafter.
Øget monitorering (dvs. inden behandlingen påbegyndes, hveranden uge i de første tre måneder med behandling og derefter hver måned intil 48 uger og derefter hver ottende til tolvte uge) er indiceret, når APTIVUS og lavdosis ritonavir gives til patienter med forhøjede værdier af ASAT og ALAT, mild leverinsufficiens, kronisk hepatitis B eller C eller anden tilgrundliggende leversygdom.
Increased monitoring (i. e. prior to initiation of therapy, every two weeks during the first three months of treatment, then monthly until 48 weeks, and then every eight to twelve weeks thereafter) is warranted when APTIVUS and low dose ritonavir are administered to patients with elevated ASAT and ALAT levels, mild hepatic impairment, chronic hepatitis-B or – C or other underlying liver disease.
Behandlingsnaive patienter:
Treatment-naïve patients:
Der var ingen fordele med hensyn til effekt (trend imod lavere effekt).
In a study performed in antiretroviral naïve patients, APTIVUS/ ritonavir 500/ 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).
Dette forsøg blev derfor stoppet tidligere end planlagt, efter 60 uger.
Therefore, this study was prematurely stopped after 60 weeks.
4 Nyreinsufficiens:
4 Renal impairment:
Hæmofili:
Haemophilia:
Der har været rapporteret øget blødning inkl. spontane hudhæmatomer og hæmartrose hos patienter med hæmofili type A og B, som behandles med proteasehæmmere.
There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with protease inhibitors.
I mere end halvdelen af de rapporterede tilfælde blev behandlingen med proteasehæmmere videreført eller påbegyndt igen, hvis den havde været seponeret.
In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
Formodning om en kausal sammenhæng foreligger, selvom virkningsmekanismen ikke er blevet forklaret.
A causal relationship has been evoked, although the mechanism of action had not been elucidated.
Hæmofilipatienter skal derfor gøres opmærksom på risikoen for øget blødning.
Haemaophiliac patients should therefore be made aware of the possibility of increased bleeding.
RESIST deltagere der blev behandlet med APTIVUS/ ritonavir tenderede til at have en øget risiko for blødning; efter 24 uger var den relative risiko 1, 98 (95% CI=1, 03; 3, 80).
RESIST participants receiving APTIVUS/ ritonavir tended to have an increased risk of bleeding; at 24 weeks the relative risk was 1.98 (95% CI=1.03, 3.80).
Ved 48 uger var den relative risiko faldet til 1, 27 (95% CI=0, 76; 2, 12).
At 48-weeks the relative risk decreased to 1.27 (95% CI=0.76, 2.12).
Betydningen af disse resultater undersøges nærmere.
The significance of this finding is being further studied.
Af disse patienter havde mange andre sygdomme eller fik samtidigt anden medicin, der kunne have forårsaget eller medvirket til disse hændelser.
Fatal and non-fatal intracranial haemorrhage (ICH) have been reported in patients receiving APTIVUS, many of whom had other medical conditions or were receiving concomitant medicinal products that may have caused or contributed to these events.
Imidlertid kan man i visse tilfælde ikke udelukke APTIVUS ’ rolle.
However, in some cases the role of APTIVUS cannot be excluded.
Der er ikke set noget unormalt mønster ved hæmatologiske eller koagulations - parametre hos patienter i al almindelighed, ej heller forudgående for udvikling af ICH.
No pattern of abnormal haematological or coagulation parameters has been observed in patients in general, or preceding the development of ICH.
Derfor er rutinemæssige målinger af koagulationsparametre ikke indiceret i behandlingen af patienter med APTIVUS.
Therefore, routine measurement of coagulation parameters is not currently indicated in the management of patients on APTIVUS.
Man har tidligere observeret øget risiko for ICH hos patienter med fremskreden HIV/ AIDS svarende til dem i behandling i de kliniske afprøvninger af APTIVUS.
An increased risk of ICH has previously been observed in patients with advanced HIV disease/ AIDS such as those treated in the APTIVUS clinical trials.
I in vitro- forøg har man set, at tipranavir hæmmer trombocytaggregationen ved koncentrationer på niveau med de koncentrationer, der ses hos patienter i APTIVUS/ ritonavir behandling.
In in vitro experiments, tipranavir was observed to inhibit human platelet aggregation at levels consistent with exposures observed in patients receiving APTIVUS/ ritonavir.
5. 3 Prækliniske sikkerhedsdata).
In rats, co-administration with vitamin E increased the bleeding effects of tipranavir (see section 5.3 Preclinical safety data).
Når APTIVUS anvendes samtidigt med lavdosis ritonavir bør det gives med forsigtighed til patienter, med risiko for øget blødning efter trauma, operation eller andre lægelige forhold, eller indtager lægemidler som er kendt for at øge blødningstendensen såsom antitrombocyt og antikoagulans - behandling eller som tager supplerende E- vitamin.
APTIVUS, co-administered with low dose ritonavir, should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other medical conditions, or who are receiving medicinal products known to increase the risk of bleeding such as antiplatelet agents and anticoagulants or who are taking supplemental vitamin E.
Baseret på et begrænset patientmateriale fra kliniske forsøg anbefales det højst at administrere 1200 IU E- vitamin per dag til voksne.
Based on the limits of exposure available from observation in clinical trials, it is recommended not to co-administer to adults more than 1200 IU vitamin E per day.
Diabetes mellitus/ hyperglykæmi:
Diabetes mellitus/ hyperglycaemia:
Der er rapporteret om fremkomst af diabetes mellitus, hyperglykæmi eller forværringer af eksisterende diabetes mellitus hos patienter, der fik antiretroviral behandling inkl. proteasehæmmere.
New onset of diabetes mellitus, hyperglycaemia or exacerbations of existing diabetes mellitus has been reported in patients receiving antiretroviral therapy, including protease inhibitors.
Hos nogle af patienterne var hyperglykæmien svær og i nogle tilfælde også forbundet med ketoacidose.
In some of these the hyperglycaemia was severe and in some cases also associated with ketoacidosis.
Mange af patienterne havde andre medicinske lidelser, hvoraf nogle blev behandlet med midler, som har været forbundet med udviklingen af diabetes mellitus eller hyperglykæmi.
Many of the patients had confounding medical conditions, some of which required therapy with agents that have been associated with the development of diabetes mellitus or hyperglycaemia.
Forhøjede lipider:
Lipid elevations:
Behandling med APTIVUS givet sammen med lavdosis ritonavir og andre antiretrovirale midler har resulteret i stigning af total triglycerider og kolesterol.
Treatment with APTIVUS co-administered with low dose ritonavir and other antiretroviral agents has resulted in increased plasma total triglycerides and cholesterol.
Måling af triglycerider og kolesterol bør udføres før initiering af tipranavir- behandlingen og under behandlingen.
Triglyceride and cholesterol testing should be performed prior to initiating tipranavir therapy and during therapy.
Behandlingsrelaterede lipidstigninger skal behandles på klinisk passende måde.
Treatment-related lipid elevations should be managed as clinically appropriate.
Fedtomfordeling:
Fat redistribution:
Antiretroviral kombinationsbehandling har været forbundet med omfordeling af legemsfedt (lipodystrofi) hos HIV- smittede patienter.
Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV infected patients.
Langtidsvirkningerne af disse hændelser kendes ikke på nuværende tidspunkt.
The long-term consequences of these events are currently unknown.
Mekanismen kendes ikke i sin fulde udstrækning.
Knowledge about the mechanism is incomplete.
Der er fremsat en hypotese om en forbindelse mellem visceral- lipomatose og proteasehæmmere og lipoatrofi og nukleosid reverse transcriptase- hæmmere.
A connection between visceral lipomatosis and protease inhibitors and lipoatrophy and nucleoside reverse transcriptase inhibitors has
5 individuelle faktorer som f. eks. alder, og med lægemiddelrelaterede faktorer som f. eks. længere varende antiretroviral- behandling og dermed forbundne metaboliske forstyrrelser.
A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
En klinisk undersøgelse bør omfatte vurdering af fysiske tegn på omfordeling af legemsfedt.
Clinical examination should include evaluation for physical signs of fat redistribution.
Det skal overvejes at måle fastende serumlipider og blodsukker.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Immunreaktiveringssyndrom:
Immune reactivation syndrome:
Hos HIV- smittede patienter med svær immundefekt på tidspunktet for initieringen af den antiretrovirale kombinationsbehandling, kan der opstå en inflammatorisk reaktion over for asymptomatiske eller residuale opportunistiske patogener og forårsage alvorlige kliniske tilstande eller forværring af symptomerne.
In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Relevante eksempler er cytomegalovirus retinitis, generaliserede og/ eller fokale mykobaketerielle infektioner og pneumocystis pneumonia.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections and Pneumocystis pneumonia.
Desuden er reaktivering af herpes simplex og herpes zoster påvist i kliniske forsøg med APTIVUS givet sammen med lavdosis ritonavir.
In addition, reactivation of herpes simplex and herpes zoster has been observed in clinical studies with APTIVUS, co-administered with low dose ritonavir.
APTIVUS indeholder makrogolglycerol- ricinoleat, som kan forårsage maveproblemer og diarre.
APTIVUS contains macrogolglycerol ricinoleate which may cause stomach upset and diarrhoea.
100 mg pr. kapsel eller 200 mg pr. dosis).
APTIVUS soft capsules contain small amounts of alcohol (7% ethanol, ie 100 mg per capsule or 200 mg per dose).
Mild til moderat udslæt, herunder urtikariel udslæt, makulopapuløst udslæt og lysfølsomhed er rapporteret hos forsøgspersoner, der har fået APTIVUS sammen med lavdosis ritonavir.
Mild to moderate rashes including urticarial rash, maculopapular rash, and photosensitivity have been reported in subjects receiving APTIVUS, co-administered with low dose ritonavir.
I et 48 ugers fase III- forsøg blev udslæt af forskellige typer observeret hos 15, 5% af de mænd og 20, 5% af de kvinder, der modtog APTIVUS sammen med en lav dosis af ritonavir.
At 48-weeks in Phase III trials rash of various types was observed in 15.5% males and 20.5% females receiving APTIVUS, co-administered with low dose ritonavir.
Desuden udviklede 33% af forsøgspersonerne udslæt i et interaktionsforsøg med raske kvindelige frivillige, der fik en enkelt dosis ethinyløstradiol efterfulgt af APTIVUS givet sammen med lavdosis ritonavir.
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.
Udslæt ledsaget af ledsmerter eller - stivhed, sammensnævring i halsen, eller generel pruritus er rapporteret hos både mænd og kvinder, der har fået APTIVUS sammen med lavdosis ritonavir.
Rash accompanied by joint pain or stiffness, throat tightness, or generalized pruritus has been reported in both men and women receiving APTIVUS co-administered with low dose ritonavir.
Osteonekrose:
Osteonecrosis:
Interaktioner:
Interactions:
Interaktionsprofilen for APTIVUS givet sammen med lavdosis ritonavir er kompleks.
The interaction profile of APTIVUS, co-administered with low dose ritonavir, is complex.
4. 5 for en beskrivelse af mekanismerne og de potentielle mekanismer, der bidrager til interaktionsprofilen for APTIVUS.
For a description of the mechanisms and potential mechanisms contributing to the interaction profile of APTIVUS, see section 4.5.
Abacavir og zidovudine:
Abacavir and zidovudine:
Samtidig behandling med APTIVUS givet sammen med lavdosis ritonavir og zidovudin eller abacavir resulterer i et significant fald i plasmakoncentrationen af disse nucleoside reverse transcriptase hæmmere (NRTIs).
The concomitant use of APTIVUS, co-administered with low dose ritonavir, with zidovudine or abacavir, results in a significant decrease in plasma concentration of these nucleoside reverse transcriptase inhibitors (NRTIs).
4. 5).
Therefore, the concomitant use of zidovudine or abacavir with APTIVUS, co-administered with low dose ritonavir, is not-recommended unless there are no other available NRTIs suitable for patient management (see section 4.5).
Proteasehæmmere:
Protease inhibitors: