FrancophonIA/ELRC3.0 huggingface dataset:
English: Common: Dizziness, headache, sciatica, syncope
Danish: Almindelig: Svimmelhed, hovedpine, iskias, synkope Øre og labyrint
English: What you need to know before you use FORSTEO
Danish: Det skal De vide, før de begynder at tage FORSTEO
English: Put the pen back into the refrigerator immediately after you have used it. Use a new injection needle for each injection and dispose of it after each use.
Danish: De skal anvende en ny nål til hver indsprøjtning og smide den væk efter brug.
English: Boehringer-Ingelheim RCV GmbH & Co KG, Dr.-Boehringer-Gasse 5-11, 1121 Vienna, Austria
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Boehringer-Ingelheim RCV GmbH & Co KG, Dr.-Boehringer-Gasse 5-11, 1121 Wien, Østrig Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Lilly France S.A., rue du colonel Lilly, 67640 Fegersheim, Frankrig
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, because occasionally they may interact (e.g. digoxin/digitalis, a medicine used to treat heart disease).
Danish: Disse kan af og til påvirke hinanden (f.eks. digoxin/digitalis, medicin til behandling af hjertesygdomme).
English: Uncommon: Emphysema
Danish: Ikke almindelig: Emfysem
English: • if you have unexplained high levels of alkaline phosphatase in your blood, which means you might have Paget's disease of bone (disease with abnormal bone changes).
Danish: hvilket betyder, at De kan have Pagets sygdom (en sygdom med unormale knogleforandringer).
English: Each dose of 80 microliters contains 20 micrograms of teriparatide*.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver dosis på 80 mikroliter indeholder 20 mikrogram teriparatid*.
English: FORSTEO is used to treat osteoporosis in adults.
Danish: FORSTEO anvendes til behandling af knogleskørhed hos voksne.
English: Uncommon: Myalgia, arthralgia, back cramp/pain* Renal and urinary disorders
Danish: Ikke almindelig: Myalgi, artralgi, rygkramper/smerter* Nyrer og urinveje
English: Unscrew the needle all the way by giving the needle cover 3 to 5 complete turns.
Danish: Skru nålen helt af ved at give nålehætten 3 til 5 hele omdrejninger.
English: FORSTEO, 20 microgram (µg) 80 microlitres solution for injection, in pre-filled pen
Danish: FORSTEO, 20 mikrogram (µg)/80 mikroliter injektionsvæske, opløsning, i fyldt pen.
English: Musculoskeletal and connective tissue disorders Very common: Pain in limb
Danish: Meget almindelig: Smerter i ekstremiteter Almindelig: Muskelkramper
English: • neuralgic pain in the leg
Danish: • nervesmerter i benene
English: Storing Your FORSTEO
Danish: Opbevaring af Deres FORSTEO-pen
English: Your doctor may advise you to take FORSTEO with calcium and vitamin D. Your doctor will tell you how much you should take each day.
Danish: Deres læge vil måske anbefale Dem at anvende FORSTEO sammen med kalk og D-vitamin.
English: Unscrew the needle all the way by giving the large needle cover 3 to 5 complete turns.
Danish: Skru nålen helt af ved at give den ydre nålehætte 3 til 5 hele omdrejninger.
English: Talk to your doctor or pharmacist before or while using FORSTEO:
Danish: Kontakt lægen eller apotekspersonalet, før De tager FORSTEO:
English: 4) Pull out the black injection button until it stops.
Danish: 4) Træk den sorte indsprøjtningsknap ud, indtil den stopper.
English: If you have a bone disease, tell your doctor.
Danish: Fortæl det til lægen, hvis De har en knoglesygdom.
English: Women of childbearing potential should use effective methods of contraception during use of FORSTEO.
Danish: Kvinder i den fertile alder bør anvende en sikker metode præventionsmetode under behandling med FORSTEO.
English: • increase in blood uric acid level
Danish: • stigning i blodets indhold af urinsyre
English: Eli Lilly Norge A.S Tlf: + 47 22 88 18 00
Danish: Tlf: + 47 22 88 18 00
English: • tiredness
Danish: • hæmorroider
English: 3) Unscrew the needle all the way by giving the large needle cover 3 to 5 complete turns.
Danish: 2) Brug den ydre nålehætte til at skrue nålen af med. 3) Skru nålen fuldstændigt af ved at give den ydre nålehætte 3 til 5 hele omdrejninger.
English: If you become pregnant, FORSTEO should be discontinued.
Danish: Hvis De bliver gravid, skal behandlingen med FORSTEO ophøre.
English: • increased heart rate
Danish: • øget hjertefrekvens (puls)
English: Read the user manual booklet, which is included in the carton for instructions on how to use the FORSTEO pen.
Danish: Læs brugervejledningen, der ligger i pakningen, for oplysninger om, hvordan De bruger FORSTEOpennen.
English: Pull off small needle protector and throw away.
Danish: Træk den indre nålehætte af, og smid den væk.
English: BMD T score of −2.7, median prednisone equivalent dose of 7.5 mg/day, and 34 % had one or more radiographic vertebral fractures; premenopausal women had a mean age of 37 years, mean lumbar spine BMD T score of −2.5, median prednisone equivalent dose of 10 mg/day, and 9 % had one or more radiographic vertebral fractures; and men had a mean age of 57 years, mean lumbar spine BMD
Danish: De præmenopausale kvinder havde en gennemsnitsalder på 37 år, en gennemsnitlig T-score på -2,5 for BMD i lænderygsøjlen, en middel prednisondosis ækvivalent med 10 mg dagligt og 9 % havde en eller flere vertebrale frakturer.
English: Name and address of the manufacturer responsible for batch release
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: m.b.H.
Danish: Icepharma hf.
English: Screw on needle until firmly attached.
Danish: Skru nålen på, indtil den sidder helt fast.
English: ask your doctor.
Danish: Spørg Deres læge, hvis der er noget, De er i tvivl om.
English: • Pregnancy and breast-feeding (see sections 4.4 and 4.6)
Danish: • Graviditet og amning (se pkt.
English: Respiratory, thoracic and mediastinal disorders Common: Dyspnoea
Danish: Luftveje, thorax og mediastinum
English: Patients with hepatic impairment
Danish: Patienter med nedsat leverfunktion:
English: NAME OF THE MEDICINAL PRODUCT FORSTEO 20 micrograms/80 microliters solution for injection in pre-filled pen
Danish: LÆGEMIDLETS NAVN FORSTEO 20 mikrogram/80 mikroliter injektionsvæske, opløsning, i fyldt pen.
English: Male osteoporosis
Danish: Osteoporose hos mænd
English: No special caution is required for patients with mild renal impairment.
Danish: For patienter med let nedsat nyrefunktion er der ingen særlige forbehold.
English: Ask your pharmacist how to throw away medicines you no longer use These measures will help to protect the environment.
Danish: Spørg på apoteket, hvordan De skal bortskaffe medicinrester.
English: Push white cap back on. Place FORSTEO in the refrigerator immediately after use.
Danish: Placer FORSTEO-pennen i køleskabet straks efter brug.
English: T score of −2.2, median prednisone equivalent dose of 10 mg/day, and 24 % had one or more radiographic vertebral fractures.
Danish: Mændene havde en gennemsnitsalder på 57 år, en gennemsnitlig T-score på -2,2 for BMD i lænderygsøjlen, en middel prednisondosis ækvivalent med 10 mg dagligt og 24 % havde en eller flere vertebrale frakturer.
English: • Keep the FORSTEO out of the sight and reach of children.
Danish: • Opbevar FORSTEO utilgængeligt for børn.
English: Following cessation of FORSTEO therapy, patients may be continued on other osteoporosis therapies.
Danish: Patienterne kan fortsætte med andre osteoporosebehandlinger efter afslutning af FORSTEObehandlingen.
English: FORSTEO 20 micrograms (µg)/ 80 microlitres solution for injection, in pre-filled pen Instructions for use
Danish: FORSTEO 20 mikrogram/80 mikroliter injektionsvæske, opløsning, i fyldt pen Teriparatid
English: Pull out black injection button until it stops.
Danish: Træk den sorte indsprøjtningsknap ud, indtil den stopper.
English: Troubleshooting
Danish: Fejlfinding
English: When you have finished, the black injection button should be all the way in. 7) If you still see the yellow shaft showing, please contact your doctor or pharmacist 8) Put the large needle cover on needle.
Danish: 7) Hvis de stadigvæk kan se det gule skaft, skal De kontakte firmaet eller Deres læge, sygeplejerske eller apotekspersonalet.
English: Put large needle cover on needle.
Danish: Sæt den ydre nålehætte over nålen.
English: Do not use FORSTEO if solid particles appear or if the solution is cloudy or coloured.
Danish: FORSTEO må ikke bruges, hvis opløsningen er uklar, farvet eller indeholder partikler.
English: Icepharma hf. Sími: + 354 540 8000
Danish: Sími: + 354 540 80 00
English: Eli Lilly Nederland B.V. Tel: + 31(0) 30 6025800
Danish: Eli Lilly farmacevtska družba, d.o.o Tel: +386 (0)1 580 00 10
English: What FORSTEO looks like and contents of the pack FORSTEO is a colourless and clear solution.
Danish: FORSTEO er en farveløs og klar opløsning.
English: Eli Lilly Ges.
Danish: Eli Lilly Norge A.S.
English: Push in the black injection button until it stops.
Danish: Tryk den sorte indsprøjtningsknap ind, indtil den stopper.
English: In patients with moderate renal impairment, FORSTEO should be used with caution.
Danish: FORSTEO bør anvendes med forsigtighed til patienter med moderat nedsat nyrefunktion.
English: • muscle cramps
Danish: • muskelkramper
English: Eli Lilly Italia S.p.A. Tel: + 39 055 42571
Danish: Tel: + 39- 055 42571
English: FORSTEO is contraindicated for use during breast-feeding.
Danish: Amning FORSTEO er kontraindiceret ved amning.
English: FORSTEO is supplied in a pre-filled pen.
Danish: 6.6 Regler for bortskaffelse og anden håndtering FORSTEO leveres i en fyldt pen.
English: Set dose
Danish: Indstil dosis
English: • a hernia of the tube that carries food to your stomach
Danish: • en udposning på spiserøret
English: In clinical trials the following reactions were reported at a ≥ 1 % difference in frequency from placebo:
Danish: I kliniske forsøg blev følgende reaktioner rapporteret med en frekvensforskel på ≥ 1 % forskel i frekvensen i forhold til placebo: Kvalme, opkastning, smerter i ekstremiteter, svimmelhed, depression og dyspnø.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)
English: The use of an anti-emetic may be necessary.
Danish: Anvendelse af et antiemetikum kan være nødvendigt.
English: Using Vistide with food and drink
Danish: Brug af Vistide sammen med mad og drikke
English: The dose you will need is calculated based on your body weight.
Danish: Den dosis, som du har brug for, beregnes ud fra din legemsvægt.
English: The other ingredients are
Danish: De øvrige indholdsstoffer er
English: Therefore, this medicine should not be used in children.
Danish: Denne medicin bør derfor ikke anvendes til børn.
English: Storage beyond 24 hours or freezing is not recommended.
Danish: Opbevaring i mere end 24 timer eller frysning anbefales ikke.
English: Ear and labyrinth disorders Not known
Danish: Øre og labyrint Ikke kendt
English: Patient monitoring
Danish: Patientmonitorering
English: • If you have ever had kidney disease.
Danish: • Hvis du på noget tidspunkt har haft en nyresygdom.
English: If you have kidney problems, Vistide may not be appropriate treatment for you.
Danish: Hvis du har nyreproblemer, er Vistide måske ikke en hensigtsmæssig behandling for dig.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND Not applicable.
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG
English: Dose in adults
Danish: Dosis til voksne
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or not known (cannot be estimated from the available data).
Danish: Frekvenser er anført: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • You should not be given Vistide if you are pregnant.
Danish: • Du må ikke få Vistide, hvis du er gravid.
English: Appropriate precautions should continue to be employed to prevent transmission of HIV.
Danish: Der bør fortsat anvendes passende prævention for at forhindre overførsel af HIV.
English: • Tell your doctor if you have diabetes mellitus.
Danish: • Fortæl din læge, hvis du har sukkersyge (diabetes).
English: The efficacy and safety of cidofovir in such conditions has not been established.
Danish: Virkning og sikkerhed af cidofovir under disse omstændigheder er ikke fastlagt.
English: Do not use Vistide after the expiry date which is stated on the label.
Danish: Brug ikke Vistide efter den udløbsdato, der står på pakningen.
English: You must take 3 doses of probenecid tablets orally on the same day as Vistide as shown in the following table:
Danish: Du skal tage 3 doser probenecidtabletter oralt på den samme dag som Vistide, som vist i følgende tabel:
English: Gilead Sciences Limited IDA Business & Technology Park Carrigtohill Co. Cork Ireland
Danish: Gilead Sciences Limited IDA Business & Technology Park Carrigtohill Co. Cork Irland
English: The signs of nephrotoxicity were partially reversible in some patients.
Danish: Tegnene på nefrotoksicitet var delvis reversible hos nogle patienter.
English: Like all medicines, Vistide can cause side effects, although not everybody gets them.
Danish: Vistide kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Probenecid is only taken on the same day that Vistide is given.
Danish: Probenecid tages kun den samme dag, som du får Vistide.
English: Both patients were hospitalised and received prophylactic oral probenecid and vigorous hydration for 3 to 7 days.
Danish: Begge patienter blev indlagt og blev behandlet med profylaktisk oral probenecid og kraftig hydrering i 3 til 7 dage.
English: What Vistide contains
Danish: Vistide indeholder
English: Vistide must be administered by a healthcare professional (doctor or nurse) in a hospital setting.
Danish: Vistide skal indgives af sundhedspersonale (en læge eller sygeplejerske) på et hospital.
English: • Vistide is not used for the treatment of HIV infection.
Danish: • Vistide bruges ikke til behandling af HIV-infektion.
English: • Kidney damage is the major side effect of Vistide treatment.
Danish: • Nyreskader er den vigtigste bivirkning ved Vistide-behandling.
English: There are no data from the use of cidofovir in pregnant women.
Danish: Der er ingen data fra anvendelse af cidofovir til gravide kvinder.
English: One patient received a single dose of 16.4 mg/kg and the other patient received a single dose of 17.3 mg/kg.
Danish: En patient fik en enkelt dosis på 16,4 mg/kg, og den anden patient fik en enkelt dosis på 17,3 mg/kg.
English: In both studies, tumours were observed within 3 months of dosing.
Danish: I begge undersøgelser blev der iagttaget tumorer i løbet af 3 måneder efter dosering.
English: Vistide has not been studied in children.
Danish: Vistide er ikke undersøgt hos børn.
English: Vistide should be infused only into veins with adequate blood flow to permit rapid dilution and distribution.
Danish: Vistide bør kun infunderes i vener med tilstrækkelig blodgennemstrømning til at sikre hurtig fortynding og fordeling.
English: Two cases of cidofovir overdose have been reported.
Danish: Der er rapporteret to tilfælde af cidofovir-overdosering.
English: It is unknown whether cidofovir/metabolites are excreted in human milk.
Danish: Det er ukendt, om cidofovir/metabolitter udskilles i human mælk.
English: Vistide will not stop you passing HIV infection onto other people so you should continue to take precautions to avoid infecting
Danish: Vistide forhindrer ikke, at du kan overføre HIV-infektion til andre mennesker, så du skal fortsætte med at tage forholdsregler, så du
English: Your doctor will monitor your kidney function before each dose of Vistide.
Danish: Din læge vil kontrollere din nyrefunktion før hver Vistide-dosis.
English: At the end of this leaflet, there is further information for healthcare professionals on how to administer Vistide.
Danish: I slutningen af denne indlægsseddel findes der yderligere information til sundhedspersonalet om, hvordan Vistide
English: Maintenance treatment
Danish: Vedligeholdelsesbehandling
English: Vistide should be used only when other agents are considered unsuitable.
Danish: Vistide bør kun anvendes, når andre lægemidler findes uegnede.
English: Vistide may cause short-term side effects such as fatigue or weakness.
Danish: Vistide kan medføre kortvarige bivirkninger såsom træthed eller mathed.
English: These side effects usually disappear when treatment with Vistide is stopped.
Danish: De nævnte bivirkninger forsvinder normalt, når behandlingen med Vistide stoppes.
English: Use of cidofovir without concomitant probenecid has not been clinically investigated.
Danish: Brug af cidofovir uden samtidig indgift af probenecid er ikke undersøgt klinisk.
English: Induction treatment.
Danish: Induktionsbehandling.
English: It is very important to tell your doctor if you are receiving other medicines that may damage your kidneys.
Danish: Det er meget vigtigt, at du fortæller din læge, hvis du får anden medicin, der kan beskadige dine
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adressse på fremstilleren ansvarlig for batch frigivelse
English: In study GS-93-107 conducted in patients who had relapsed after treatment with other agents, the median time to retinitis progression was 115 days.
Danish: I studie GS-93-107 udført med patienter, som havde fået tilbagefald efter behandling med andre midler, var mediantiden for retinitis-progression 115 dage.
English: Maintenance treatment.
Danish: Vedligeholdelsesbehandling.
English: Probenecid is not supplied with Vistide and should be obtained via the Marketing Authorisation Holder of probenecid.
Danish: Probenicid leveres ikke sammen med Vistide og bør leveres via indehaveren af markedsføringstilladelsen for probenecid.
English: The in vitro sensitivity to cidofovir is shown in the following table:
Danish: In vitro-følsomheden over for cidofovir er vist i følgende tabel.
English: • If you are allergic (hypersensitive) to cidofovir or any of the other ingredients of Vistide.
Danish: • Hvis du er overfølsom (allergisk) over for cidofovir eller et af de øvrige indholdsstoffer.
English: Probenecid increases the AUC of zidovudine.
Danish: Probenecid øger AUC for zidovudin.
English: • During treatment with Vistide you should receive regular follow-up eye examinations for possible eye irritation, inflammation or swelling.
Danish: • Under behandling med Vistide bør du regelmæssigt få foretaget øjenundersøgelser for mulig øjenirritation, betændelse eller hævelse.
English: Direct intraocular injection of Vistide is contraindicated; direct injection may be associated with significant decreases in intraocular pressure and impairment of vision.
Danish: Direkte intraokulær injektion af Vistide er kontraindiceret; direkte injektion kan være forbundet med væsentlige fald i det intraokulære tryk og synssvækkelse.
English: Cases of acute renal failure have been reported after only one or two doses of cidofovir.
Danish: Der er rapporteret tilfælde af akut nyresvigt efter kun én eller to doser cidofovir.
English: No cross-resistance between foscarnet and cidofovir was seen with foscarnet-selected mutants.
Danish: Der blev ikke iagttaget krydsresistens mellem foscarnet og cidofovir med foscarnet-selekterede mutanter.
English: Adequate precautions including the use of appropriate safety equipment are recommended for the preparation, administration and disposal of Vistide.
Danish: Der bør træffes passende forholdsregler inklusive brug af korrekt sikkerhedsudstyr ved tilberedning, administration og bortskaffelse af Vistide.
English: Any pain, redness or itching of the eye or changes in your vision should be promptly reported to your doctor so that your treatment can be reviewed.
Danish: Smerte, rødme eller kløe i øjet eller ændringer af synet skal straks rapporteres til din læge, således at din behandling kan blive revurderet.
English: If you can tolerate the additional fluid load, your doctor may administer a second litre of fluid.
Danish: Hvis du kan tåle større væskemængde, kan din læge indgive yderligere en liter væske.
English: In both cases, the overdose occurred during the first induction dose and no additional cidofovir therapy was administered.
Danish: I begge tilfælde forekom overdoseringen under den første induktionsdosis, og der blev ikke indgivet yderligere cidofovir.
English: • Vistide caused reduced testes weight and low sperm count (hypospermia) in animals.
Danish: • Vistide har medført nedsat testikelvægt og lavt sædcelleantal (hypospermi) hos dyr.
English: Women of childbearing potential/Contraception in males and females:
Danish: Kvinder i den fertile alder/Kontraception til mænd og kvinder:
English: Cidofovir has negligible influence on the ability to drive and use machines.
Danish: Cidofovir påvirker i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: You are not to be given Vistide.
Danish: I så fald må du ikke få Vistide.
English: Haemolytic anaemia has also occurred, and may be associated with G6DP deficiency.
Danish: Hæmolytisk anæmi er også set og kan være forbundet med G6DP-mangel.
English: If visible particles or discolouration are observed, the vial should not be used.
Danish: Hvis der iagttages synlige partikler eller misfarvning, må hætteglasset ikke anvendes.
English: • Probenecid may interact with other medicines commonly used in the treatment of AIDS and AIDS-related illnesses, such as zidovudine (AZT).
Danish: • Probenecid kan påvirke anden medicin, som normalt bruges i behandlingen af aids og aids-relaterede sygdomme, såsom zidovudin (AZT).
English: Vistide is for intravenous infusion only.
Danish: Vistide er kun til intravenøs infusion.
English: Before each administration of Vistide, serum creatinine and urine protein levels should be investigated.
Danish: Før hver administration af Vistide bør serumkreatinin og proteinindhold i urinen undersøges.
English: If Vistide contacts the skin, wash membranes and flush thoroughly with water.
Danish: Hvis Vistide kommer i kontakt med huden, vaskes og skylles grundigt med vand.
English: (See sub-sections “How to take probenecid with Vistide” and “How IV fluids are given before Vistide” below.)
Danish: (Se underpunkterne “Sådan tages probenecid med Vistide” og “Sådan gives intravenøse væsker før Vistide” nedenunder.)
English: Starting (induction) treatment
Danish: Startbehandling (induktion)
English: Vistide will not cure CMV retinitis but may improve your condition by delaying progression of the disease.
Danish: Vistide helbreder ikke CMV-nethindebetændelse, men kan forbedre din tilstand ved at forsinke sygdommens udvikling.
English: Suspension of maintenance treatment with cidofovir should be considered in accordance with local recommendations for the management of HIV infected patients.
Danish: Ophør af cidofovir-vedligeholdelsesbehandling bør overvejes i overensstemmelse med lokale anbefalinger for kontrol af HIV-inficerede patienter.
English: If you have accidentally been given more Vistide than prescribed for you, tell your doctor immediately.
Danish: Hvis du utilsigtet har fået mere Vistide, end du har fået ordineret, skal du omgående kontakte din
English: Proteinuria appears to be an early and sensitive indicator of cidofovir-induced nephrotoxicity.
Danish: Proteinuri synes at være en tidlig og følsom indikator for cidofovirinduceret nefrotoksicitet.
English: Vistide is formulated for intravenous infusion only and must not be administered by other methods including intraocular injection or topically.
Danish: Vistide er kun formuleret til intravenøs infusion og må ikke administreres på anden måde, herunder intraokulær injektion eller topikalt.
English: The table below lists the adverse reactions identified through clinical trials or post-marketing surveillance by system organ class (SOC) and frequency.
Danish: Tabellen nedenfor viser en oversigt over bivirkninger set i kliniske forsøg eller efter markedsføring opstillet efter systemorganklasser (SOC) og frekvens.