FrancophonIA/ELRC3.0 huggingface dataset:
English: 50 vials (suspension) 2 x 25 vials (emulsion)
Danish: 50 hætteglas (suspension) 2 x 25 hætteglas (emulsion)
English: Intramuscular use suspension (H5N1): vial (glass) emulsion (adjuvant): vial (glass)
Danish: Intramuskulær anvendelse suspension (H5N1): hætteglas (glas) emulsion (adjuvans): hætteglas (glas)
English: 3.75 µg HA Suspension and Emulsion for emulsion for injection
Danish: Suspension og emulsion til injektionsvæske, emulsion.
English: This is of particular concern, as these patients and patients with renal impaired are already particularly prone to developing hyperkalaemia.
Danish: Dette er særlig betænkeligt, fordi disse patienter og patienter med nedsat nyrefunktion i forvejen har tendens til hyperkaliæmi.
English: RAS-acting agents include angiotensinconverting enzyme inhibitors (ACE-inhibitors) such as benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril and zofenopril), angiotensin receptor blockers (ARBs) such as candesartan, telmisartan, valsartan, irbesartan, eprosartan, olmesartan, losartan and azilsartan and direct renin inhibitors such as aliskiren.
Danish: RAS-aktive stoffer omfatter angiotensin-konverteringsenzymhæmmere (ACE-hæmmere) såsom benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril og zofenopril), angiotensinreceptorantagonister (ARB) såsom candesartan, telmisartan, valsartan, irbesartan, eprosartan, olmesartan, losartan og azilsartan samt direkte reninhæmmere såsom aliskiren.
English: The PRAC therefore concluded that the product information of all RAS-acting agents should be revised to reflect the identified risks and provide guidance to prescribers and patients.
Danish: PRAC konkluderede derfor, at produktinformationen for alle RAS-aktive stoffer burde revideres i henhold til de konstaterede risici og burde indeholde vejledning til ordinerende læger og patienter.
English: In addition, the metaanalysis suggested that using multiple RAS-acting agents may not be more beneficial than using a single RAS-acting agent in terms of reducing overall mortality.
Danish: Desuden tyder metaanalyser på, at brug af flere RAS-aktive stoffer ikke nødvendigvis har fordele fremfor brug af et enkelt RAS-aktivt stof hvad angår reduktion af den samlede dødelighed.
English: The PRAC was also of the opinion that the contraindication based on the ALTITUDE5 study data regarding the concomitant use of ACEinhibitors or ARBs with aliskiren-containing products in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m2) was confirmed by the additional data reviewed and that it should also be implemented in the product information of ARBs and ACE-inhibitors.
Danish: PRAC var endvidere af den opfattelse, at de gennemgåede yderligere data bekræftede den kontraindikation, der byggede på ALTITUDE5-undersøgelsens data om anvendelse af ACE-hæmmere eller ARB sammen med aliskiren hos patienter med diabetes mellitus eller nedsat nyrefunktion (glomerulær filtrationshastighed (GFR) < 60 ml/min/1,73 m2), og at den også burde indgå i produktinformationen for ARB og ACE-hæmmere.
English: renal failure compared to monotherapy, in particular in patients with diabetic nephropathy.
Danish: hyperkaliæmi og nyresvigt, navnlig hos patienter med diabetisk nefropati.
English: In particular, a number of trials in heart failure patients have shown that the addition of a second RAS-acting agent may reduce hospital admissions for heart failure in patients with heart failure, which is considered a meaningful clinical endpoint.
Danish: En række undersøgelser hos patienter med hjerteinsufficiens har således vist, at tillæg af endnu et RAS-aktivt stof kan reducere indlæggelser af sådanne patienter, hvilket anses for et meningsfuldt klinisk endepunkt.
English: For candesartan- and valsartan-containing products, which are also authorised in the treatment of heart failure, additional information was agreed upon to reflect the fact that dual RAS blockade therapy in combination with an ACE-inhibitor may be of benefit in certain patients who cannot use other heart failure treatments, provided that they are used under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Danish: For produkter indeholdende candesartan og valsartan, der også er godkendt til behandling af hjerteinsufficiens, blev der vedtaget supplerende oplysninger om, at behandling med dobbelt RAS-blokering i kombination med end ACE-hæmmere kan være til fordel for visse patienter, som ikke kan få anden behandling for hjerteinsufficiens, forudsat at det sker under opsyn af speciallæge og hyppig tæt overvågning af nyrefunktion, elektrolytter og blodtryk.
English: A warning was introduced to state that dual RAS blockade therapy through the combined use of ACE-inhibitors, ARBs or aliskiren is not recommended and, if considered absolutely necessary, should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Danish: Der blev indsat en advarsel om, at behandling med dobbelt RAS-blokering gennem kombineret brug af ACE-hæmmere og ARB eller aliskiren frarådes og, hvis den anses for ubetinget nødvendig, kun må ske under opsyn af speciallæge og hyppig tæt overvågning af nyrefunktion, elektrolytter og blodtryk.
English: In particular, the publication of a metaanalysis by Makani et al1 involving over 68,000 patients raised concerns that combining several RAS-acting agents may be associated with an increased risk of hyperkalaemia, hypotension and kidney failure, compared with the single use of one RAS-acting agent.
Danish: En metaanalyse foretaget af Makani et al1 med over 68 000 patienter medførte således betænkelighed ved, at kombination af flere RAS-aktive stoffer kan tænkes at medføre større risiko for hyperkaliæmi, hypotension og nyresvigt end monoterapi med et RASaktivt stof.
English: Having considered the new available evidence from the scientific literature and given the seriousness of the identified safety concerns, the Italian Medicines Agency (AIFA) decided to initiate a review under Article 31 of Council Directive 2001/83/EC on 17 April 2013, referring the matter to the Pharmacovigilance Risk Assessment Committee (PRAC) and requesting the PRAC to issue a recommendation on the benefit-risk of dual RAS blockade therapy through the combined use of ACE-inhibitors, ARBs or aliskiren and whether any regulatory measures should be taken on the marketing authorisations of the products involved in this procedure.
Danish: Efter gennemgang af den foreliggende nye evidens fra den videnskabelige litteratur og på baggrund af alvorligheden af de fundne sikkerhedsproblemer indledte den italienske lægemiddelstyrelse (AIFA) en gennemgang i henhold til artikel 31 i Rådets direktiv 2001/83/EF af 17. april 2013 ved at indbringe sagen for Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC).
English: The PRAC was of the opinion that there is considerable evidence from large clinical trials and meta-analyses which conclusively demonstrates that dual RAS blockade therapy through the combined use of ACE-inhibitors, ARBs or aliskiren is associated with an increased risk of adverse events, including hypotension, hyperkalaemia and
Danish: PRAC fandt, at omfattende evidens fra store kliniske undersøgelser og metaanalyser konklusivt viser, at behandling med dobbelt RAS-blokering gennem kombineret brug af ACE-hæmmere og ARB eller aliskiren medfører større risiko end monoterapi for bivirkninger, herunder hypotension,
English: Annex I Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Danish: Videnskabelige konklusioner og begrundelse for ændring af betingelserne for markedsføringstilladelserne samt detaljeret redegørelse for den videnskabelige begrundelse for afvigelserne fra anbefalingen fra PRAC (Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for Lægemiddelvurdering)
English: Whereas
Danish: Bilag I
English: What is PREZISTA?
Danish: Hvad er PREZISTA?
English: Date of first authorisation: 12 February 2007 Date of latest renewal: 19 September 2013
Danish: Dato for første markedsføringstilladelse: 12. februar 2007 Dato for seneste fornyelse: 19. september 2013
English: Recommendations concerning co-administration
Danish: Anbefalinger vedrørende co-administration
English: based upon non dose normalised values
Danish: baseret på ikke-dosisnormaliserede værdier
English: These are mentioned above under the heading ‘Do not combine PREZISTA with any of the following medicines:'
Danish: Disse er nævnt ovenfor under overskriften "Du må ikke tage PREZISTA sammen med følgende medicin:"
English: Other corticosteroids: interaction not studied.
Danish: Andre kortikosteroider: Interaktion er ikke undersøgt.
English: Several of the interaction studies (indicated by
Danish: Adskillige af interaktionsstudierne (markeret med
English: PREZISTA works by reducing the amount of HIV in your body.
Danish: PREZISTA virker ved at reducere mængden af hiv i kroppen.
English: - Take PREZISTA with food.
Danish: - Tag PREZISTA sammen med mad.
English: Number of baseline mutations
Danish: Antal af baseline-mutationer
English: People taking PREZISTA may still develop infections or other illnesses associated with HIV infection.
Danish: Personer, der tager PREZISTA, kan stadig udvikle infektioner eller andre sygdomme forbundet med hiv-infektion.
English: Your doctor should do blood tests before you start PREZISTA.
Danish: Din læge bør udføre nogle blodprøver, før du starter på PREZISTA.
English: If you forget to take PREZISTA
Danish: Hvis du har glemt at tage PREZISTA
English: PREZISTA with food and drink See section 3 ‘How to take PREZISTA.'
Danish: Brug af PREZISTA sammen med mad og drikke Se punkt 3 "Sådan skal du tage PREZISTA".
English: PREZISTA/ritonavir may be considered as an alternative.
Danish: PREZISTA/ritonavir kan overvejes som et alternativ.
English: The effects of PREZISTA might be reduced if you take any of the following products.
Danish: Virkningen af PREZISTA kan blive nedsat, hvis du tager et eller flere af følgende produkter.
English: Even when you feel better, do not stop taking PREZISTA.
Danish: Selvom du har det bedre, må du ikke stoppe med at tage PREZISTA.
English: The clinical relevance of this increase is unknown therefore, PREZISTA should be used with caution.
Danish: Den kliniske relevans af denne stigning kendes ikke, og PREZISTA bør derfor anvendes med forsigtighed.
English: PREZISTA might reduce its effectiveness.
Danish: PREZISTA kan nedsætte virkningen af disse.
English: If you belong to this age group, please discuss with your doctor if you can use PREZISTA.
Danish: Hvis du tilhører denne aldersgruppe, skal du spørge din læge, om du kan anvende PREZISTA.
English: - Tell your doctor if you have had problems with your liver before, including hepatitis B or C infection.
Danish: - Fortæl din læge, hvis du tidligere har haft problemer med leveren, herunder hepatitis B- eller C-infektion.
English: Treatment of overdose with PREZISTA consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Danish: Behandling ved overdosering af PREZISTA består i generelle supportive foranstaltninger, herunder monitorering af vitaltegn og observation af patientens kliniske tilstand.
English: The effects of other medicines might be influenced if you take PREZISTA.
Danish: Virkningen af anden medicin kan blive påvirket, hvis du tager PREZISTA.
English: R(-) methadone AUC ↓ 16% R(-) methadone Cmin ↓ 15% R(-) methadone Cmax ↓ 24%
Danish: R(-) methadon AUC ↓ 16 % R(-) methadon Cmin ↓ 15 % R(-) methadon Cmax ↓ 24 %
English: Tell your doctor immediately if you are pregnant, planning to become pregnant or if you are breast-feeding.
Danish: Fortæl straks din læge, hvis du er gravid, planlægger at blive gravid eller ammer.
English: PREZISTA oral suspension can be used in patients unable to swallow PREZISTA tablets.
Danish: PREZISTA oral suspension kan anvendes til patienter, der ikke kan synke PREZISTA tabletter.
English: Some side effects are typical for anti-HIV medicines in the same family as PREZISTA.
Danish: Nogle bivirkninger er typiske for hiv-medicin i samme gruppe som PREZISTA.
English: The most frequent adverse reactions reported were diarrhoea (28%), nausea (23%), and rash (16%).
Danish: De hyppigst rapporterede bivirkninger var diarré (28 %), kvalme (23 %) og udslæt (16 %).
English: (not applicable for PREZISTA co-administered with ritonavir)
Danish: (Gælder ikke for PREZISTA coadministreret med ritonavir)
English: Close the bottle with the cap after use, and store PREZISTA oral suspension as directed in section 5 below.
Danish: Sæt låget på flasken efter brug og opbevar PREZISTA oral suspension som anvist under punkt 5 nedenfor.
English: Shake the bottle vigorously prior to each dose.
Danish: Ryst flasken kraftigt før hver dosis.
English: 90 film-coated tablets (3 bottles containing 30 tablets each) The bottles are not to be distributed individually.
Danish: 90 filmovertrukne tabletter (3 beholdere a 30 tabletter) Tabletbeholderne må ikke udleveres enkeltvist.
English: The dosage of other medicines might need to be changed since either their own or PREZISTA's therapeutic effect or side effects may be influenced when combined.
Danish: Doseringen af anden medicin skal muligvis ændres, da behandlingsvirkningen eller bivirkninger af enten denne eller PREZISTA kan blive påvirket, når de kombineres.
English: However, unbound darunavir concentrations were approximately 55% (Child-Pugh Class A) and 100% (Child-Pugh Class B) higher, respectively.
Danish: Dog var koncentrationer af ubundet darunavir henholdsvis ca. 55 % (ChildPugh klasse A) og 100 % (Child-Pugh klasse B) højere.
English: PREZISTA is not a cure for HIV infection.
Danish: PREZISTA kan ikke helbrede hiv-infektion.
English: Do not combine PREZISTA with any of the following medicines If you are taking any of these, ask your doctor about switching to another medicine.
Danish: Du må ikke tage PREZISTA sammen med følgende medicin Hvis du tager et af disse lægemidler, skal du tale med din læge om at skifte til en anden medicin.
English: Your doctor may evaluate how severe your liver disease is before deciding if you can take PREZISTA.
Danish: Din læge kan vurdere, hvor alvorlig din leversygdom er, inden han eller hun beslutter, om du kan tage PREZISTA.
English: The combination product lopinavir/ritonavir this anti-HIV medicine belongs to the same class as PREZISTA
Danish: Kombinationsproduktet lopinavir/ritonavir denne medicin mod hiv tilhører samme gruppe som PREZISTA
English: According to the TLOVR non-virologic failure censored algorithm 24 (30.0%) patients experienced virological failure, of which 17 (21.3%) patients were rebounders and 7 (8.8%) patients were non-responders.
Danish: Ifølge den TLOVR non-virologisk svigt censorerede algoritme oplevede 24 (30,0 %) patienter virologisk svigt, af hvilke 17 (21,3 %) patienter fik tilbagefald, og 7 (8,8 %) patienter ikke responderede på behandlingen.
English: These are: - muscle pain, tenderness or weakness.
Danish: Disse omfatter: - muskelsmerter, -ømhed eller svaghed.
English: - This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Danish: - Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosisenhed, dvs. det er i det væsentlige natriumfrit.
English: There are some medicines that you must not combine with PREZISTA.
Danish: Nogle typer medicin må du ikke tage sammen med PREZISTA.
English: There is no specific antidote for overdose with PREZISTA.
Danish: Der findes ingen specifik antidot mod PREZISTA.
English: One PREZISTA dose is
Danish: En dosis PREZISTA er
English: * Using cross-study comparisons to historical pharmacokinetic data
Danish: * Ved brug af historiske farmakokinetiske data på tværs af studier.
English: Hence, the use of creatinine clearance as an estimate of renal elimination capacity may be misleading.
Danish: Brug af kreatinin-clearance til vurdering af renal elimineringsevne kan således være misvisende.
English: The safety and efficacy of PREZISTA have not been established in patients with severe underlying liver disorders and PREZISTA is therefore contraindicated in patients with severe hepatic impairment.
Danish: Sikkerheden og virkningen af PREZISTA er ikke blevet fastslået hos patienter med alvorlige, underliggende leversygdomme, og PREZISTA er derfor kontraindiceret til patienter med svært nedsat leverfunktion.
English: Your doctor will advise you how to deal with your symptoms or whether PREZISTA must be stopped.
Danish: Din læge vil rådgive dig om, hvad du skal gøre ved symptomerne, eller om du skal holde op med at tage PREZISTA.
English: PREZISTA has only been used in limited numbers of patients 65 years or older.
Danish: PREZISTA har kun været anvendt til et begrænset antal patienter over 65 år.
English: Imputations according to the TLOVR algorithm Based on a normal approximation of the difference in % response NC=F
Danish: I henhold til TLOVR-algoritmen (time to loss of viral response) Baseret på en normal approksimation af forskellen i % respons NC=F
English: Due to uncertainties regarding the rate of development of the human blood brain barrier and liver enzymes, PREZISTA with low dose ritonavir should not be used in paediatric patients below 3 years of age.
Danish: På grund af usikkerheden omkring udviklingshastigheden af den humane blod-hjerne-barriere og leverenzymer bør PREZISTA plus lavdosis ritonavir ikke bruges til pædiatriske patienter under 3 år.
English: Pull the plunger until the top of the barrel meets the line that matches the dose prescribed by your health care provider.
Danish: Træk stemplet ud, indtil stempelpladen er ud for den streg, der svarer til den dosis, din læge har foreskrevet.
English: PREZISTA might increase the risk of bleeding.
Danish: PREZISTA kan øge risikoen for blødning.
English: PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of erectile dysfunction Avanafil Sildenafil Tadalafil Vardenafil
Danish: PHOSPHODIESTERASE-TYPE 5 (PDE-5)-HÆMMERE Til behandling af erektil dysfunktion Avanafil Sildenafil Tadalafil Vardenafil
English: PREZISTA oral suspension is available in packs of one bottle.
Danish: PREZISTA oral suspension fås i pakninger med en flaske.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: BOTTLE LABEL FOR ORAL SUSPENSION
Danish: ETIKET PÅ FLASKEN MED ORAL SUSPENSION
English: Because of both the potential for HIV transmission and the potential for adverse reactions in breast-fed infants, mothers should be instructed not to breast-feed under any circumstances if they are receiving PREZISTA.
Danish: Både på grund af risiko for overførsel af hiv og risiko for bivirkninger hos de ammede spædbørn, skal mødre instrueres i, at de under ingen omstændigheder må amme, hvis de behandles med PREZISTA.
English: PREZISTA/ritonavir 10 kg to < 15 kg N=5
Danish: PREZISTA/ritonavir 10 kg til < 15 kg N=5
English: PREZISTA does not require any special storage conditions.
Danish: PREZISTA kræver ingen særlige forholdsregler vedrørende opbevaring.
English: Take the dose of PREZISTA.
Danish: Udtag din dosis PREZISTA.
English: • In ART-experienced patients with no darunavir resistance associated mutations (DRV-RAMs)*
Danish: ● Hos ART-erfarne patienter uden mutationer associeret med darunavirresistens (DRV-RAMs)*,
English: - Tell your doctor if you have diabetes.
Danish: - Fortæl din læge, hvis du har sukkersyge (diabetes).
English: MedDRA system organ class Frequency category
Danish: MedDRA- systemorganklasse Hyppighedskategori
English: common angioedema, pruritus, urticaria rare drug reaction with eosinophilia and systemic symptoms*, Stevens-Johnson syndrome*
Danish: almindelig angiødem, pruritus, urticaria sjælden lægemiddelreaktion med eosinofili og systemiske symptomer*, Stevens-Johnson syndrom*
English: If there is a need to combine PREZISTA/ritonavir and carbamazepine, patients should be monitored for potential carbamazepine-related adverse events.
Danish: Hvis der er behov for at kombinere PREZISTA/ritonavir med carbamazepin, skal patienterne monitoreres for potentielle carbamazepinrelaterede bivirkninger.
English: Of the 44 patients taking ritonavir oral solution, 27 switched to the 100 mg capsule formulation and exceeded the weight-based ritonavir dose without changes in observed safety.
Danish: Ud af de 44 patienter, der fik ritonavir oral opløsning, skiftede 27 til 100 mg kapselformuleringen og overskred derved den vægtbaserede ritonavirdosis uden observerede ændringer i sikkerhed.
English: Driving and using machines Do not operate machines or drive if you feel dizzy after taking PREZISTA.
Danish: Trafik- og arbejdssikkerhed Du må ikke betjene maskiner eller køre bil, hvis du føler dig svimmel efter indtagelse af PREZISTA.
English: Pregnant or breast-feeding mothers should not take PREZISTA with cobicistat.
Danish: Gravide eller ammende mødre bør ikke tage PREZISTA sammen med cobicistat.
English: If prescribed PREZISTA twice daily the child must take one dose in the morning, and one dose in the evening.
Danish: Hvis PREZISTA er ordineret to gange dagligt, skal barnet tage en dosis om morgenen og en dosis om aftenen.
English: Paediatric population The safety assessment in paediatric patients is based on the 48-week analysis of safety data from three Phase II trials.
Danish: Pædiatrisk population Sikkerhedsvurderingen for pædiatriske patienter er baseret på analysen af sikkerhedsdata efter 48 uger fra tre fase II-studier.
English: PREZISTA is also available as an oral suspension for use in patients who are unable to swallow PREZISTA tablets (please refer to the Summary of Product Characteristics for PREZISTA oral suspension).
Danish: PREZISTA fås også som oral suspension til anvendelse hos patienter, der ikke kan synke PREZISTA tabletter (se produktresuméet for PREZISTA oral suspension).
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking PREZISTA.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager PREZISTA.
English: 150 mg once every other day rifabutin AUC rifabutin Cmin
Danish: Rifabutin 150 mg hver anden dag rifabutin AUC rifabutin Cmin
English: • For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.
Danish: ● til behandling af hiv-1-infektion hos voksne patienter, som tidligere har været i antiretroviral behandling (ART-erfarne), inklusive patienter, der tidligere har fået omfattende præmedicinering
English: Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
Danish: Tag altid lægemidlet nøjagtigt som beskrevet i denne indlægsseddel eller efter lægens, apotekspersonalets eller sundhedspersonalets anvisning.
English: When the recommendation is the same for PREZISTA when co-administered with a low dose ritonavir or cobicistat, the term “boosted PREZISTA” is used.
Danish: Når anbefalingen er den samme for PREZISTA, uanset om det co-administreres med en lav dosis ritonavir eller cobicistat, anvendes termen ”boostet PREZISTA”.
English: Other severe side effects were diabetes (common) and inflammation of the pancreas (uncommon).
Danish: Andre alvorlige bivirkninger var diabetes (almindelig) og betændelse i bugspytkirtlen (ikke almindelig).
English: Limited information is available in this population, and therefore, PREZISTA should be used with caution in this age group (see sections 4.4 and 5.2).
Danish: Der foreligger kun begrænsede oplysninger om denne population, og PREZISTA skal derfor anvendes med forsigtighed til denne aldersgruppe (se pkt.