FrancophonIA/ELRC3.0 huggingface dataset:
English: • Attach the syringe with the vial adapter or transfer needle to the powder vial.
Danish: • Sæt sprøjten med hætteglasadapteren fast på eller stik nålen til overførsel ind i hætteglasset med pulveret.
English: If you use a vial adapter, tip the syringe to remove it from the vial.
Danish: Hvis du anvender en hætteglasadapter, vip da sprøjten for at fjerne den fra hætteglasset.
English: If using a vial adapter, tip the syringe to remove it from the vial.
Danish: Hvis der anvendes en hætteglasadapter, vippes sprøjten for at fjerne den fra hætteglasset.
English: Healthy subjects
Danish: Raske personer
English: If using a transfer needle, insert the transfer needle into the rubber stopper of the solvent vial.
Danish: Hvis der anvendes en nål til overførsel, stikkes nålen ind i gummiproppen på hætteglasset med solvens.
English: Posology
Danish: Dosisinterval
English: Remove the protective cap from the vial adapter.
Danish: Fjern beskyttelsespapiret fra hætteglasadapteren.
English: Turn over the protective cap, and snap the vial adapter onto the vial.
Danish: • Drej beskyttelseshætten på og klik hætteglasadaptoren fast på hætteglasset.
English: • 1 vial adapter
Danish: • 1 hætteglasadaptor
English: If the protective paper is not fully sealed or if it is broken, do not use the vial adapter.
Danish: Brug ikke hætteglasadaptoren, hvis beskyttelsespapiret ikke er helt forseglet, eller hvis det er i stykker.
English: Hold the syringe slightly tilted with the vial facing downwards.
Danish: Hold sprøjten let på skrå med hætteglasset nedad.
English: The usual dose is 90 micrograms for every 1 kilogram you weigh; you can repeat the injection every 2-3 hours until bleeding is controlled.
Danish: Du kan gentage injektionen hver 2. til 3. time, indtil blødningen er kontrolleret.
English: • Screw the syringe tightly onto the vial adapter on the solvent vial.
Danish: • Skru sprøjten godt fast på hætteglasadapteren på hætteglasset med solvens.
English: Attach the plunger rod and the syringe
Danish: Klargøring af hætteglasset og sprøjten
English: Hold the syringe with the vial upside down and pull the plunger to draw all the solution into the syringe.
Danish: Hold sprøjten med hætteglasset opad og træk stemplet ud, til al opløsningen er i sprøjten
English: NovoSeven is now ready for injection.
Danish: NovoSeven kan nu injiceres.
English: If using a transfer needle, screw the transfer needle tightly onto the syringe.
Danish: Hvis der anvendes en nål til overførsel, skrues nålen fast på sprøjten.
English: • Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.
Danish: • Træk stempelstangen en smule ned for at trække den opblandede injektionsvæske ind i sprøjten.
English: Screw the syringe securely onto the vial adapter until resistance is felt.
Danish: Skru sprøjten godt fast på hætteglasadapteren indtil du mærker modstand.
English: If you use a transfer needle, make sure to penetrate the centre of the rubber stopper.
Danish: Hvis der anvendes en nål til overførsel, sørg da for at stikke igennem midten af gummiproppen.
English: If you inject too much NovoSeven, get medical advice at once.
Danish: Kontakt omgående lægen, hvis du kommer til at injicere for meget NovoSeven.
English: Push the plunger rod to inject all the solvent into the vial.
Danish: Pres stempelstangen ned for at injicere alt solvensen ind i hætteglasset.
English: • 1 pre-filled syringe with solvent for reconstitution
Danish: • 1 fyldt sprøjte med solvens til opblanding (rekonstitution)
English: Eptacog alfa (activated) 8 mg/vial (400 KIU/vial), 1 mg/ml after reconstitution
Danish: Eptacog alfa (aktiveret) 8 mg/hætteglas (400 KIE/hætteglas), 1 mg/ml efter opblanding
English: • 1 vial with solvent for reconstitution
Danish: • 1 hætteglas med solvens til opblanding (rekonstitution)
English: Eptacog alfa (activated) 5 mg/vial (250 KIU/vial), 1 mg/ml after reconstitution
Danish: Eptacog alfa (aktiveret) 5 mg/hætteglas (250 KIE/hætteglas), 1 mg/ml efter opblanding
English: If you touch the spike on the vial adapter germs from your fingers can be transferred.
Danish: Hvis du rører spidsen af hætteglasadaptoren, kan det overføre bakterier fra dine fingre.
English: NovoSeven is presented as powder and solvent for solution for injection containing 5 mg eptacog alfa (activated) per vial (corresponds to 250 KIU/vial).
Danish: NovoSeven markedsføres som pulver og solvens til injektionsvæske, opløsning og indeholder 5 mg eptacog alfa (aktiveret) per hætteglas (svarende til 250 KIE/hætteglas).
English: If the protective paper is not fully sealed or it is broken do not use the vial adapter.
Danish: Brug ikke hætteglasadaptoren, hvis beskyttelsespapiret ikke er helt forseglet eller er ødelagt.
English: If using a transfer needle, make sure the transfer needle tip is in the solvent.
Danish: Hvis der anvendes en nål til overførsel, sørg da for at nålens spids er helt nede i solvensen.
English: Eptacog alfa (activated) 2 mg/vial (100 KIU/vial), 1 mg/ml after reconstitution
Danish: Eptacog alfa (aktiveret) 2 mg/hætteglas (100 KIE/hætteglas), 1 mg/ml efter opblanding
English: site, pulmonary embolism, thromboembolic events of the liver
Danish: området, lungeemboli, tromboemboliske hændelser i leveren herunder vena portaetrombose, trombose i nyrevene, tromboflebit, overfladisk
English: NovoSeven is presented as powder and solvent for solution for injection containing 8 mg eptacog alfa (activated) per vial (corresponds to 400 KIU/vial).
Danish: NovoSeven markedsføres som pulver og solvens til injektionsvæske, opløsning og indeholder 8 mg eptacog alfa (aktiveret) per hætteglas (svarende til 400 KIE/hætteglas).
English: If you are using a transfer needle, make sure that the transfer needle tip is in the solvent.
Danish: Hvis du anvender en nål til overførsel sørg da for, at nålens spids er helt nede i solvensen.
English: Once attached, remove the protective cap. Take care not to touch the spike on the vial adapter.
Danish: Vær forsigtig med ikke at røre toppen af adapteren.
English: NovoSeven powder and solvent vials should be at room temperature at reconstitution.
Danish: NovoSeven hætteglassene med pulver og solvens tempereres til stuetemperatur inden opblanding.
English: NovoSeven is presented as powder and solvent for solution for injection containing 1 mg eptacog alfa (activated) per vial (corresponds to 50 KIU/vial).
Danish: NovoSeven markedsføres som pulver og solvens til injektionsvæske, opløsning og indeholder 1 mg eptacog alfa (aktiveret) per hætteglas (svarende til 50 KIE/hætteglas).
English: Eptacog alfa (activated) 1 mg/vial (50 KIU/vial), 1 mg/ml after reconstitution
Danish: Eptacog alfa (aktiveret) 1 mg/hætteglas (50 KIE/hætteglas), 1 mg/ml efter opblanding
English: • Screw the pre-filled syringe securely onto the vial adapter until resistance is felt.
Danish: • Skru den fyldte sprøjte fast på hætteglasadaptoren, indtil der mærkes modstand.
English: NovoSeven is presented as powder and solvent for solution for injection containing 2 mg eptacog alfa (activated) per vial (corresponds to 100 KIU/vial).
Danish: NovoSeven markedsføres som pulver og solvens til injektionsvæske, opløsning og indeholder 2 mg eptacog alfa (aktiveret) per hætteglas (svarende til 100 KIE/hætteglas).
English: When to treat yourself
Danish: Ved egenbehandling
English: Powder vial
Danish: Mave-tarmkanalen
English: If you inject more NovoSeven than you should
Danish: Hvis du har brugt for meget NovoSeven
English: NovoSeven 8 mg Powder for injection Eptacog alfa (activated) IV
Danish: NovoSeven 8 mg Pulver til injektionsvæske Eptacog alfa (aktiveret) i.v.
English: Pre-filled syringe with solvent Syringe tip (under syringe cap)
Danish: Sprøjtespids (under sprøjtehætte)
English: Patients with acquired haemophilia
Danish: Patienter med erhvervet hæmofili
English: If the syringe cap is loose or missing, do not use the pre-filled syringe.
Danish: Brug ikke sprøjten, hvis sprøjtehætten er løs eller mangler.
English: NovoSeven 5 mg Powder for injection Eptacog alfa (activated) IV
Danish: NovoSeven 5 mg Pulver til injektionsvæske Eptacog alfa (aktiveret) i.v.
English: NovoSeven 2 mg Powder for injection Eptacog alfa (activated) IV
Danish: NovoSeven 2 mg Pulver til injektionsvæske Eptacog alfa (aktiveret) i.v.
English: NovoSeven 1 mg Powder for injection Eptacog alfa (activated) IV
Danish: NovoSeven 1mg Pulver til injektionsvæske Eptacog alfa (aktiveret) i.v.
English: Do not store the reconstituted solution without advice from your doctor or nurse.
Danish: Du må kun opbevare opløsningen, hvis du har rådført dig med en læge eller sygeplejerske.
English: If you use a transfer needle, make sure that the transfer needle tip is in the solution.
Danish: Hvis der anvendes en nål til overførsel, sørg da for, at nålens spids er helt nede i opløsningen.
English: Once attached, do not remove the vial adapter from the vial.
Danish: Når den er sat på, fjernes beskyttelseshætten fra hætteglasadapteren.
English: Turn the syringe with the vial upside down and withdraw the contents of the vial into the syringe.
Danish: Vend sprøjten med hætteglasset på hovedet og træk indholdet i hætteglasset ind i sprøjten.
English: Safely dispose of the syringe, vials and any unused product.
Danish: Sprøjte, hætteglas samt ikke anvendt lægemiddel kasseres på en forsvarlig måde.
English: Gently swirl the vial until all the powder is dissolved.
Danish: Sving hætteglasset forsigtigt til alt pulveret er opløst.
English: Do not lift the vial adapter from the vial when removing the protective cap.
Danish: Løft ikke hætteglasadaptoren op fra hætteglasset,
English: • Hold the syringe with the solvent vial upside down.
Danish: • Sæt hætteglasadapteren fast på hætteglasset med solvens.
English: Hold the prefilled syringe slightly tilted with the vial pointing downwards.
Danish: Hold sprøjten let skråt med hætteglasset nedad.
English: Pull the plunger rod slightly downwards to draw the mixed solution into the syringe.
Danish: Træk stempelstangen en smule ned for at trække injektionsvæsken ind i sprøjten.
English: • If you get any side effects, talk to your doctor.
Danish: • Tal med lægen, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: If you notice visible particles or discolouration, do not use it. Use a new package instead.
Danish: Brug den ikke, hvis der er visuelle partikler eller misfarvning.
English: If you use a transfer needle, remove the transfer needle from the vial, replace the transfer needle cap, and twist the transfer needle off the syringe.
Danish: Hvis du bruger en nål til overførsel, skal du fjerne nålen fra hætteglasset.
English: Contact your doctor who will decide on continuing the treatment or not.
Danish: Kontakt din læge, der vil beslutte om behandlingen skal fortsætte eller ej.
English: Date of first authorisation: 28 January 2000 Date of latest renewal: 28 January 2015
Danish: Dato for første markedsføringstilladelse: 28. januar 2000 Dato for seneste fornyelse: 28. januar 2015
English: This was not confirmed in a dog study or in clinical trials.
Danish: Dette blev ikke bekræftet ved studie på hunde eller ved kliniske studier.
English: Renagel must be taken three times per day with meals.
Danish: Renagel skal tages tre gange dagligt i forbindelse med måltider.
English: In the event of a possible overdose you should contact your doctor immediately.
Danish: I tilfælde af en eventuel overdosis, skal du straks søge læge.
English: • if you have low levels of phosphate in your blood (your doctor will check this for you).
Danish: • Hvis du har lavt fosfatindhold i blodet (din læge vil måle dette for dig)
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen, hvis du tager eller for nylig har taget eller måske skal tage anden medicin.
English: Your doctor will check for interactions between Renagel and other medicines on a regular basis.
Danish: Lægen vil jævnligt kontrollere for interaktioner mellem Renagel og anden medicin.
English: Efficacy and safety of Renagel has not been studied in patients with:
Danish: Renagels sikkerhed og effekt er ikke undersøgt hos patienter med:
English: • if you are not on dialysis
Danish: • Hvis du er ikke i dialyse
English: Common Uncommon Very Rare
Danish: Ikke almindelig Meget sjælden Ikke kendt
English: Renagel is not absorbed and may affect the bioavailability of other medicinal products.
Danish: Renagel absorberes ikke, men kan påvirke biotilgængeligheden af andre lægemidler.
English: The average actual daily dose used in the chronic phase of a one year clinical study was 7 grams of sevelamer.
Danish: Den gennemsnitlige, faktiske daglige dosis i den kroniske fase i et klinisk studie over 1 år var 7 g sevelamer.
English: Serum phosphate should be tested every two to three weeks until a stable serum phosphate level is reached and on a regular basis thereafter.
Danish: Serumphosphat skal testes hver anden eller tredje uge, indtil der er opnået et stabilt serumphosphatniveau, og derefter jævnligt.
English: ATC code: V03AE02.
Danish: ATC-kode: V03AE02.
English: In clinical trials mean total and LDL cholesterol declined by 15-31%.
Danish: Ved kliniske studier blev middel total og LDL kolesterol reduceret med 15-31%.
English: There is at present insufficient data to exclude the possibility of folate deficiency during long term Renagel treatment.
Danish: Der er i øjeblikket utilstrækkelige data til at udelukke muligheden for folatmangel ved langtidsbehandling med Renagel.
English: The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10),
Danish: Indberetningsfrekvensen klassificeres som meget almindelig (≥ 1/10), almindelig (≥1/100 til <1/10),
English: It cannot be excluded that Renagel can bind fat-soluble vitamins contained in ingested food.
Danish: Det kan ikke udelukkes, at Renagel kan binde fedtopløselige vitaminer i indtaget mad.
English: However, in vitro and in vivo studies have indicated that Renagel does not have genotoxic potential.
Danish: Dog har in vitro og in vivo studier antydet, at Renagel ikke har noget genotoksisk potentiale.
English: Name and address of the manufacturer responsible for batch release Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Danish: Navn og adresse på fremstilleren (fremstillerne) ansvarlig(e) for batchfrigivelse Genzyme Ireland Limited., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
English: As data on the chronic use of sevelamer for over one year are not yet available, potential absorption and accumulation of sevelamer during long-term chronic treatment cannot be totally excluded (see section 5.2).
Danish: Da der ikke foreligger data om kronisk anvendelse af sevelamer i over et år, kan potentiel absorption og akkumulation af sevelamer under langvarig kronisk behandling ikke helt udelukkes (se pkt.
English: Adverse reactions from these studies (299 patients), from uncontrolled clinical trials (384 patients), and that were spontaneously reported from post-marketing experience are listed by frequency in the table below.
Danish: Bivirkninger fra disse studier (299 patienter), fra ukontrollerede kliniske studier (384 patienter) og fra spontane indberetninger post-marketing, er anført efter hyppighed i nedenstående tabel.
English: Renagel does not contain calcium.
Danish: Renagel indeholder ikke calcium.
English: Renagel alone is not indicated for the control of hyperparathyroidism.
Danish: Renagel alene er ikke indiceret til kontrol af hyperparathyreose.
English: The following side effects have been reported in patients taking Renagel: Very common (may affect more than 1 in 10 people): nausea, vomiting.
Danish: Følgende bivirkninger er rapporteret hos patienter, der tager Renagel: Meget almindelig (kan påvirke flere end 1 ud af 10 personer): kvalme, opkastning
English: Talk to your doctor while taking Renagel:
Danish: Tal med din læge, mens du tager Renegal:
English: One gram of Renagel contains approximately 180 mg (5.1 mEq) chloride.
Danish: Et gram Renagel indeholder cirka 180 mg (5,1 mEq) chlorid.
English: • Renagel should not be taken at the same time as ciprofloxacin (an antibiotic).
Danish: • Renagel må ikke tages samtidig med ciprofloxacin (et antibiotikum).
English: Renagel is unlikely to affect your ability to drive or to use machines.
Danish: Det er usandsynligt, at Renagel påvirker din evne til at køre bil eller betjene maskiner.
English: Acidosis, increased serum chloride levels
Danish: Acidose, forhøjede chloridniveauer i serum
English: Renagel contains sevelamer as the active ingredient.
Danish: Renagel indeholder sevelamer som er det aktive stof.
English: uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated form the available data).
Danish: ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • gastrointestinal motility disorders including untreated or severe gastroparesis, diverticulosis retention of gastric contents and abnormal or irregular bowel motion
Danish: • gastrointestinale motilitetsproblemer, inklusive ubehandlet eller svær gastroparese, retention af ventrikelindhold pga. divertikulose, unormal eller uregelmæssig tarmbevægelse
English: Consequently, Renagel should not be taken simultaneously with ciprofloxacin.
Danish: Derfor bør Renagel ikke tages samtidig med ciprofloxacin.
English: The most frequently occurring (≥5% of patients) adverse reactions were all in the gastrointestinal disorders system organ class.
Danish: De hyppigst forekommende (≥ 5 % af patienterne) bivirkninger var alle i systemorganklassen mavetarm-kanalen.
English: Package sizes are:
Danish: Der findes følgende pakningsstørrelser:
English: Peritonitis is a known complication in patients receiving peritoneal dialysis (PD) and in a clinical study with Renagel, a number of peritonitis cases were reported.
Danish: Peritonitis er en kendt komplikation hos patienter i peritonealdialyse (PD), og i et klinisk studie med Renagel blev et antal peritonitistilfælde rapporteret.
English: Sevelamer decreases the incidence of hypercalcaemic episodes as compared to patients using calcium based phosphate binders alone, probably because the product itself does not contain calcium.
Danish: Sevelamer nedsætter forekomsten af hyperkalcæmi-tilfælde sammenlignet med patienter, der alene indtager calcium-baserede phosphatbindemidler, formentlig fordi selve præparatet ikke indeholder calcium.
English: Since Renagel does not contain calcium your doctor might prescribe additional calcium tablets.
Danish: Da Renagel ikke indeholder calcium, kan lægen ordinere supplerende calciumtabletter.
English: The dose range may vary between 1 and 10 tablets per meal.
Danish: Doseringsområdet kan variere mellem 1 og 10 tabletter pr. måltid.
English: You should expect to be monitored more carefully for problems with low levels of vitamins A, D, E, K and folic acid.
Danish: Desuden skal du forvente at blive overvåget nøjere for problemer med lave niveauer af vitamin A, D, E, K og folinsyre.
English: If you forget to take Renagel
Danish: Hvis du har glemt at tage Renagel
English: Although no clinically significant serum chloride increase has been observed in the clinical studies, serum chloride should be monitored as is done in the routine follow-up of a dialysis patient.
Danish: Selv om der ikke er observeret nogen klinisk signifikant forøgelse af serumchlorid i de kliniske studier, bør serumchlorid monitoreres, som det sker ved rutinemæssig opfølgning hos en dialysepatient.
English: Renagel contains sevelamer, a non-absorbed phosphate binding poly (allylamine hydrochloride) polymer, free of metal and calcium.
Danish: Renagel indeholder sevelamer, en ikke-absorberet phosphatbindende poly (allylamin hydrochlorid) polymer, der er fri for metal og calcium.
English: • The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used in transplant patients) may be reduced by Renagel.
Danish: • Effekten af medicin såsom ciclosporin, mycophenolatmofetil og tacrolimus (medicin, som anvendes til transplantationspatienter) kan reduceres af Renagel.
English: In reproduction studies there was no evidence that sevelamer induced embryolethality, foetotoxicity or teratogenicity at the doses tested (up to 1 g/kg/day in rabbits and up to 4.5 g/kg/day in rats).
Danish: Ved reproduktionsstudier var der intet tegn på, at sevelamer medførte fosterdødelighed, fostertoksicitet eller teratogenitet ved de testede doser (op til 1 g/kg/dag hos kaniner og op til 4,5 g/kg/dag hos rotter).
English: In interaction studies in healthy volunteers, Renagel had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol.
Danish: Ved interaktionsstudier med raske frivillige havde Renagel ingen virkning på biotilgængeligheden af digoxin, warfarin, enalapril eller metoprolol.
English: Serum chloride may increase during Renagel treatment as chloride may be exchanged for phosphorus in the intestinal lumen.
Danish: Serumchlorid kan blive forøget under behandling med Renagel, idet chlorid kan udveksles med phosphor i det intestinale lumen.
English: • Hypophosphataemia
Danish: • Hypophosphatæmi
English: Renagel should only be given to pregnant or breast-feeding women if clearly needed.
Danish: Renagel må kun gives til gravide eller ammende kvinder, hvis der er et klart behov.
English: Patients should take Renagel with meals and adhere to their prescribed diets.
Danish: Patienterne skal indtage Renagel sammen med måltider og holde sig til deres foreskrevne diæter.
English: In a clinical trial of one-year duration, Renagel had no adverse effect on bone turnover or mineralisation compared to calcium carbonate.
Danish: I et klinisk studie af et års varighed viste Renagel ingen negativ påvirkning af knogleomsætning eller mineralisering sammenlignet med calciumcarbonat.
English: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, the Netherlands
Danish: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Holland
English: • patients with a history of major gastrointestinal surgery Therefore caution should be exercised when Renagel is used in patients with these disorders.
Danish: • patienter med større gastrointestinale kirurgiske indgreb i anamnesen Der skal derfor udvises forsigtighed, når Renagel anvendes hos patienter med disse problemer.
English: For patients previously on phosphate binders, Renagel should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.
Danish: Patienter, der tidligere har taget phosphatbindere, bør have Renagel på gram til gram basis under monitorering af serumphosphatniveauet for at sikre en optimal daglig dosis.
English: If you do not take multivitamin supplements you may also develop low levels of vitamins A, E, K and folic acid in your blood and therefore your doctor may monitor these levels and prescribe supplemental vitamins as necessary.
Danish: Hvis du ikke tager multivitamintilskud, kan du også udvikle lave niveauer af vitamin A, E, K og folinsyre i blodet, og lægen kan derfor holde øje med disse niveauer og ordinere vitamintilskud om nødvendigt.
English: When you switch from another phosphate binder to Renagel, your doctor might consider monitoring the levels of bicarbonate in your blood more closely because Renagel may decrease the levels of bicarbonate.
Danish: Ved skift fra en anden fosfatbinder til Renagel vil lægen måske overveje at overvåge bikarbonatniveauet i dit blod nøjere, fordi Renagel kan reducere bikarbonatniveauerne.
English: In the clinical studies in haemodialysis patients, sevelamer alone did not have a consistent and clinically significant effect on serum intact parathyroid hormone (iPTH).
Danish: Ved kliniske studier med hæmodialysepatienter havde sevelamer givet alene ikke nogen vedvarende og klinisk signifikant virkning på serumintakt parathyroideahormon (iPTH).
English: What you need to know before you take Renagel Do not take Renagel:
Danish: Det skal du vide, før du begynder at tage Renagel Tag ikke Renagel: