FrancophonIA/ELRC3.0 huggingface dataset:
English: Vistide is used to treat an eye infection called CMV retinitis in patients with AIDS (Acquired Immunodeficiency Syndrome).
Danish: Vistide anvendes til at behandle en øjeninfektion, der hedder CMV-nethindebetændelse, hos patienter med aids (erhvervet immundefektsyndrom).
English: Prevention of nephrotoxicity
Danish: Nefrotoksicitet
English: To reduce the risk of nausea and/or vomiting associated with taking probenecid, you should eat food before each dose.
Danish: Du kan nedsætte risikoen for kvalme og/eller opkastning forbundet med behandling med probenecid, hvis du spiser inden hver dosis.
English: The safety and efficacy of Vistide has not been demonstrated in diseases other than CMV retinitis in patients with AIDS.
Danish: Vistides sikkerhed og virkning er ikke blevet påvist ved andre sygdomme end CMV-retinitis hos
English: In vivo activity against HCMV was confirmed with controlled clinical studies of cidofovir for the treatment of CMV retinitis in patients with AIDS, which demonstrated statistically significant delays in time to CMV retinitis progression for patients on cidofovir when compared to control patients.
Danish: In vivo-aktivitet over for HCMV blev bekræftet i kontrollerede kliniske undersøgelser af cidofovir, hvor aids-patienter med CMV-retinitis blev behandlet.
English: • Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as these may interact with
Danish: • Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: Vistide 75 mg/ml concentrate for solution for infusion Cidofovir
Danish: Vistide 75 mg/ml koncentrat til infusionsvæske, opløsning Cidofovir
English: 6 weeks prior to mating and for 2 weeks post mating had decreased litter sizes and live births per litter and increased early resorptions per litter.
Danish: Hunrotter, der blev doseret intravenøst 1 gang om ugen med 1,2 mg/kg/uge eller mere i op til 6 uger forud for parring og i 2 uger efter parring, havde reducerede kuldstørrelser, færre levendefødte pr. kuld og forøget tidlig resorption pr. kuld.
English: You should receive a total of one litre of 0.9% (normal) saline solution intravenously (as a drip into a vein) before each Vistide dose.
Danish: Du skal i alt have 1 liter 0,9 % saltvandsopløsning ved hjælp af et drop i en blodåre (intravenøst) før hver Vistide-infusion.
English: Vistide vials should be visually inspected for particulate matter and discolouration prior to administration.
Danish: Vistide hætteglas skal efterses for partikler og misfarvning forud for indgivelse.
English: The appropriate dose of Vistide should be transferred from the vial to an infusion bag containing 100 ml 0.9% (normal) saline solution.
Danish: Den relevante Vistide-dosis overføres fra hætteglasset til en infusionspose, der indeholder 100 ml 0,9 % (normal) saltvandsopløsning.
English: Evidence for a nephroprotective effect for probenecid was shown in a 52-week study conducted in cynomolgus monkeys administered cidofovir 2.5 mg/kg once weekly intravenously with 1 g of probenecid given orally.
Danish: Bevis på probenecids nefrobeskyttende virkning blev vist i et 52 ugers studie på cynomolgus aber, der fik cidofovir 2,5 mg/kg i.v.
English: To minimise potential nephrotoxicity, oral probenecid and intravenous saline prehydration must be administered with each Vistide infusion (see section 4.4).
Danish: For at minimere den potentielle nefrotoksicitet skal der gives oral probenecid og præhydrering med natriumchlorid-infusionsvæske i forbindelse med hver Vistide-infusion (se pkt.
English: particular attention should be paid to assessing renal function before and during administration of Vistide.
Danish: Da ældre mennesker ofte har nedsat glomerulær funktion, skal man være specielt opmærksom på, at vurdere nyrefunktionen før og under administration af Vistide.
English: Interruption, and possibly discontinuation, is required for changes in renal function.
Danish: Ved ændring i nyrefunktion er det nødvendigt midlertidigt at afbryde og muligvis helt at seponere behandlingen.
English: There is a risk that concomitant treatment of Vistide with products containing tenofovir disoproxil fumarate may give rise to a pharmacodynamic interaction and increase the risk of Fanconi syndrome (see section 4.4).
Danish: Der er en risiko for, at samtidig behandling med Vistide og præparater, der indeholder tenofovirdisoproxilfumarat, kan forårsage en farmakodynamisk interaktion og øge risikoen for
English: Reports of renal failure (plus events possibly caused by renal failure, e.g. blood creatinine increased, proteinuria, glycosuria) received during post-marketing surveillance include some which were fatal.
Danish: Der er modtaget rapporter om nyresvigt (samt hændelser, der muligvis er forårsaget af nyresvigt, f.eks. forhøjet kreatinin, proteinuri og glykosuri).
English: Each vial contains approximately 2.5 mmol (or 57 mg) sodium per vial (5 ml) as a constituent of the excipients.
Danish: Hvert hætteglas (5 ml) indeholder ca. 2,5 mmol (svarende til 57 mg) natrium som en del af
English: The entire volume should be infused intravenously into the patient at a constant rate over a period of 1 hour by use of a standard infusion pump.
Danish: Hele mængden skal infunderes intravenøst til patienten med konstant hastighed i løbet af 1 time ved hjælp af en standard-infusionspumpe.
English: For those patients who fully recover from cidofovir associated renal toxicity, the benefits-risk balance of reintroducing cidofovir has not yet been evaluated.
Danish: Fordele og ulemper ved at genoptage cidofovirbehandlingen af patienter, der er fuldt restituerede efter cidofovirrelateret nefrotoksicitet, er endnu ikke blevet vurderet.
English: Normal saline is given to lower the risk of kidney damage.
Danish: Der gives saltvandsopløsning for at nedsætte risikoen for nyreskader.
English: Refrigerated infusion bags should be allowed to warm to room temperature prior to use.
Danish: Afkølede poser skal have tid til at opnå stuetemperatur, før de bruges.
English: Vistide is supplied in single-use vials.
Danish: Vistide leveres i hætteglas til engangsbrug.
English: In addition probenecid may also cause other adverse reactions including anorexia, gingival pain, flushing, alopecia, dizziness, anaemia, and pollakiuria.
Danish: Ud over de her anførte bivirkninger kan probenecid også give andre bivirkninger herunder anoreksi, tandkødssmerter, rødmen, alopeci, svimmelhed, anæmi og pollakiuri.
English: No tumours were observed in cynomolgus monkeys administered cidofovir intravenously once weekly for 52 weeks at doses up to 2.5 mg/kg/week.
Danish: Der blev ikke iagttaget tumorer i cynomolgus-aber, der fik cidofovir intravenøst 1 gang ugentlig i 52 uger ved doser op til
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter begrænset recept (Jf. bilag I: Produktresumé, pkt.
English: The first litre of saline solution should be infused over a 1 hour period immediately before the cidofovir infusion, and the second litre, if given, infused over a 1-3 hour period beginning simultaneously with the cidofovir infusion or starting immediately after the infusion of cidofovir.
Danish: Denne anden liter saltvandsopløsning skal indgives i løbet af 1 til 3 timer, og infusionen påbegyndes enten samtidig med Vistide-infusionen, eller umiddelbart efter infusionen er afsluttet.
English: • aminoglycosides, pentamidine or vancomycin (for bacterial infections)
Danish: • Medicin, som indeholder tenofovir, der anvendes til at behandle HIV 1-infektion og/eller • aminoglykosider, pentamidin eller vancomycin (imod bakterielle infektioner)
English: 2 g probenecid
Danish: 2 g probenecid 1 g probenecid 1 g probenecid 4 g probenecid
English: Pharmacotherapeutic group: Antivirals for systemic use, nucleosides and nucleotides excluding reverse transcriptase inhibitors, ATC code: J05AB12
Danish: Farmakoterapeutisk klassifikation: Antiviralt middel til systemisk brug, nukleosider og nukleotider ekskl.
English: Renal insufficiency:
Danish: Leverinsufficiens:
English: Compatibility of Vistide with Ringer's Solution, Lactated Ringer's Solution or bacteriostatic infusion fluids has not been evaluated.
Danish: Vistides forligelighed med Ringer-opløsning, Ringer-laktat eller bakteriostatiske infusionsvæsker er
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: - Spørg lægen eller på apoteket, hvis der er mere du vil vide.
English: Beginning two weeks after the completion of induction treatment, the recommended maintenance dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hour) administered once every two weeks.
Danish: Den anbefalede cidofovir-vedligeholdelsesdosis er 5 mg/kg legemsvægt (givet som intravenøs infusion med konstant hastighed i løbet af 1 time) 1 gang hver anden uge.
English: NAME OF THE MEDICINAL PRODUCT Vistide 75 mg/ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Vistide 75 mg/ml koncentrat til infusionsvæske, opløsning
English: Each ml contains 75 mg cidofovir anhydrous.
Danish: 1 ml indeholder 75 mg vandfrit cidofovir.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vistide 75 mg/ml concentrate for solution for infusion Cidofovir
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Vistide 75 mg/ml koncentrat til infusionsvæske, opløsning
English: Concomitant administration of Vistide and other potentially nephrotoxic agents is contraindicated (see section 4.4).
Danish: Samtidig behandling med Vistide og andre potentielt nefrotoksiske lægemidler er kontraindiceret (se
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs
English: You should also read the probenecid package leaflet.
Danish: Du bør også læse indlægssedlen for
English: Adverse reactions possibly or probably related to cidofovir based on clinical trial experience and post-marketing surveillance
Danish: Bivirkninger, der formodentlig eller sandsynligvis er forbundet med cidofovir, baseret på
English: Each vial contains 375 mg/5 ml cidofovir anhydrous.
Danish: Hvert hætteglas indeholder 375 mg/5 ml vandfrit cidofovir.
English: General disorders and administration site conditions Very common
Danish: Almene symptomer og reaktioner på administrationsstedet
English: With a syringe, transfer under aseptic conditions the appropriate dose of Vistide from the vial to an infusion bag containing 100 ml 0.9% (normal) saline solution, and mix thoroughly.
Danish: Træk den korrekte mængde Vistide op af hætteglasset med en sprøjte og overfør den under aseptiske forhold til en infusionspose indeholdende 100 ml 0,9 % (normal) natriumchlorid-infusionsvæske og bland grundigt.
English: Excipients
Danish: Pancreatitis
English: The entire volume of the bag should be infused into the patient's vein at a constant rate over a period of 1 hour using a standard infusion pump.
Danish: Hele posens indhold infunderes i patientens vene med en konstant hastighed i løbet af en 1 time ved hjælp af en standardinfusionspumpe.
English: Excipients:
Danish: Nyreinsufficiens:
English: Therapy must be accompanied by administration of oral probenecid and adequate intravenous saline prehydration (see section 6.6 for information on obtaining probenecid) with each cidofovir dose.
Danish: I behandlingen skal hver cidofovirdosis suppleres med oral indgift af probenecid og tilstrækkelig præhydrering med natriumchlorid-infusionsvæske (se pkt.
English: 2 hours after end of Vistide infusion
Danish: Vedligeholdelsesbehandling startes 2 uger efter afslutning af induktionsbehandlingen.
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Danish: Hvis du vil have yderligere oplysninger om Vistide, skal du henvende dig til den lokale repræsentant.
English: Iritis, uveitis, hypotony of the eye (see section 4.4)
Danish: Iritis, uveitis, nedsat intraokulært tryk (se pkt.
English: The entire volume of the bag will be infused into your vein at a constant rate over a period of 1 hour using a standard infusion pump.
Danish: Du får hele posens indhold via et drop i en blodåre med en konstant hastighed i løbet af en 1 time ved hjælp af en standardinfusionspumpe.
English: Nervous system disorders Very common
Danish: Mave-tarm-kanalen Meget almindelig
English: Men should practice barrier birth control methods during and for 3 months
Danish: Mænd bør anvende kondom under og i
English: Dilute before use.
Danish: Vistide hætteglas skal efterses før brug.
English: This leaflet was last approved in
Danish: Udløbsdatoen (EXP) er den sidste dag i den nævnte måned.
English: For other NRTI drugs administered concomitantly with probenecid, reference should be made to their respective prescribing information for any appropriate recommendations.
Danish: For beskrivelse af andre nukleosidanalog-reverstranskriptase-inhibitorer (NRTI) anvendt sammen med probenecid henvises til de relevante produktbeskrivelser.
English: Vistide must be administered with oral probenecid and intravenous saline as described below (see section 4.4 for appropriate recommendations, and under section 6.6 for information on obtaining probenecid).
Danish: Vistide skal administreres sammen med oral probenecid og natriumchlorid-infusionsvæske som beskrevet nedenfor (se pkt.
English: Neutropenia
Danish: Diarré
English: The following information is intended for medical or healthcare professionals only: Vistide vials should be inspected visually prior to use.
Danish: Følgende oplysninger er tiltænkt læger og sundhedspersonale:
English: IC50 (µM)
Danish: Cidofovirhæmning af virus-multiplikation i celle kultur IC50 (µM)
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.
Danish: Tal omgående med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: Gilead Sciences S.r.l.
Danish: Gilead Sciences Netherlands B.V.
English: Possible side effects of taking probenecid
Danish: 6.6 vedrørende information om hvordan man får fat i probenecid).
English: Headache
Danish: Vistide
English: 1 g probenecid
Danish: 1 gang ugentligt med 1 g oral probenecid.
English: (Invented) name Strength Pharmaceutical form Route of administration
Danish: (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Paknings-størrelse
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Danish: MF (EU)-nummer (Særnavn) Navn Styrke
English: You may need urgent medical treatment.
Danish: Du kan have brug for øjeblikkelig lægehjælp.
English: Adopted at the 6-9 July 2015 PRAC
Danish: Vedtaget 6.-9. juli 2015 PRAC
English: You must tell your doctor immediately if you notice these serious side effects mentioned.
Danish: Du skal straks sige det til lægen, hvis du bemærker nogen af de nævnte alvorlige bivirkninger.
English: Talk to your doctor before taking {Drug name}:
Danish: Kontakt lægen, før du tager {lægemidlets navn}:
English: Donepezil - Rhabdomyolysis (EPITT no 18261)
Danish: Donepezil - rhabdomyolyse (EPITT nr. 18261)
English: Remember to also mention any other ill-effects like pain in your joints.
Danish: Husk også at nævne andre negative virkninger såsom ledsmerter.
English: • Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine.
Danish: • Svaghed, ømhed eller smerter i musklerne, navnlig, hvis du samtidig føler dig utilpas eller har feber eller mørkfarvet urin.
English: SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Danish: SCLE efter tidligere behandling med en protonpumpehæmmer kan øge risikoen for SCLE med andre protonpumpehæmmere.
English: Proton pump inhibitors are associated with very infrequent cases of SCLE.
Danish: Protonpumpehæmmere er forbundet med meget sjældne tilfælde af SCLE.
English: They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis).
Danish: Dette kan skyldes en abnorm nedbrydning af muskelvæv, som kan være livstruende og medføre nyreproblemer (en tilstand kaldet rhabdomyolyse).
English: • if you have ever had a skin reaction after treatment with a medicine similar to {Drug name} that reduces stomach acid.
Danish: • hvis du nogensinde har fået hudreaktioner efter at have taget et lægemiddel af samme slags som {lægemidlets navn}, der nedsætter syreindholdet i maven.
English: New product information wording - Extracts from PRAC recommendations on signals
Danish: Ny ordlyd til produktinformation - uddrag af PRAC's anbefalinger om signaler
English: Dexlansoprazole; esomeprazole; lansoprazole; omeprazole; pantoprazole; rabeprazole - Subacute cutaneous lupus erythematosus (EPITT no 18119)
Danish: Dexlansoprazol, esomeprazol, lansoprazol, omeprazol, pantoprazol, rabeprazol - subakut kutan lupus erythematosus (EPITT nr. 18119)
English: Subacute cutaneous lupus erythematosus (SCLE)
Danish: Subakut kutan lupus erythematosus (SCLE)
English: Section 4: Possible side effects • Frequency 'not known': rash, possibly with pain in the joints
Danish: Afsnit 4: Bivirkninger • Hyppighed "ikke kendt": Udslæt, eventuelt med ledsmerter
English: If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with {Drug name}.
Danish: Hvis du får udslæt, især på de dele af huden, der er udsat for sol, skal du snarest muligt sige det til lægen, da du kan være nødt til at holde op med at tage {lægemidlets navn}.
English: Section 4: Possible side effects
Danish: Afsnit 4: Bivirkninger
English: If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping {Drug name}.
Danish: Hvis sådanne hudreaktioner optræder, navnlig på hudområder udsat for sol, og er ledsaget af artralgi, bør patienten straks søge læge, og lægen bør overveje at seponere {lægemidlets navn}.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/450962/2015
Danish: Ny ordlyd til produktinformation - uddrag af PRAC's anbefalinger om signaler EMA/PRAC/522617/2015
English: Musculoskeletal, connective tissue and bone disorders Frequency ‘very rare': Rhabdomyolysis* (To be inserted in the table footnote): * Rhabdomyolysis has been reported to occur independently of neuroleptic malignant syndrome and in close temporal association with donepezil initiation or dose increase.
Danish: Hyppighed "meget sjælden": Rhabdomyolyse* (Indsættes i fodnoten til tabellen): * Der er indberettet rhabdomyolyse, som optræder uafhængigt af malignt neuroleptikasyndrom og med tidsmæssig sammenhæng med opstart af donepezil behandling eller ved dosisforøgelse af donepezil.
English: Frequency 'not known': Subacute cutaneous lupus erythematosus (see section 4.4).
Danish: Hyppighed "ikke kendt": Subakut kutan lupus erythematosus (se pkt.
English: Section 2: What you need to know before you take {Drug name}
Danish: Afsnit 2: Det skal du vide, før du begynder at tage {lægemidlets navn} Advarsler og forsigtighedsregler
English: Package Leaflet (both prescription and non-prescription)
Danish: Indlægsseddel (både receptpligtig og håndkøbsmedicin)
English: Summary of Product Characteristics (both prescription and non-prescription)
Danish: Produktresumé (både receptpligtig og Håndkøbsmedicin)
English: The European Commission granted a marketing authorisation valid throughout the EU for Pantozol Control on 12 June 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pantozol Control den 12. juni 2009.
English: The full EPAR for Pantozol Control can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Pantozol Control findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Pantozol Control.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pantozol Control.
English: The recommended dose of Pantozol Control is one tablet once a day until symptoms have stopped.
Danish: Den anbefalede dosis Pantozol Control er én tablet én gang dagligt, indtil symptomerne forsvinder.
English: It is used for long-term treatments and is also used to treat a wider range of gastrointestinal diseases (conditions affecting the gut) than Pantozol Control.
Danish: Det anvendes til langtidsbehandling og anvendes desuden til behandling af et større felt af gastrointestinale sygdomme (lidelser i tarmene) end Pantozol Control.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pantozol Control.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Pantozol Control.
English: The most common side effects with Pantozol Control (seen in around 1 patient in 100) are diarrhoea and headache.
Danish: De hyppigste bivirkninger ved Pantozol Control (som optræder hos omkring 1 ud af 100 patienter) er diarré og hovedpine.
English: For more information about treatment with Pantozol Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pantozol Control, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Pantozol Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients.
Danish: Pantozol Control må ikke anvendes af patienter, der er overfølsomme (allergiske) over for pantoprazol, soja eller andre af indholdsstofferne.
English: Pantozol Control is used for the short-term treatment of the symptoms of acid reflux in adults.
Danish: Pantozol Control anvendes til korttidsbehandling af symptomer på syrerefluks hos voksne.
English: The CHMP therefore decided that Pantozol Control's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede derfor, at fordelene ved Pantozol Control er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Pantozol Control.
English: Pantozol Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Pantozol.
Danish: Pantozol Control svarer til et referencelægemiddel ved navn Pantozol, som allerede er godkendt i Den Europæiske Union (EU).
English: Pantozol Control is a medicine that contains the active substance pantoprazole.
Danish: Pantozol Control er et lægemiddel, der indeholder det aktive stof pantoprazol.
English: Pantozol Control pantoprazole
Danish: Pantozol Control pantoprazol
English: The active substance in Pantozol Control, pantoprazole, is a proton pump inhibitor.
Danish: Det aktive stof i Pantozol Control, pantoprazol, er en protonpumpehæmmer.
English: For the full list of all side effects reported with pantoprazole, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved pantoprazol fremgår af indlægssedlen.
English: The reference medicine, Pantozol, is only available with a prescription.
Danish: Referencelægemidlet Pantozol udleveres kun efter recept.