FrancophonIA/ELRC3.0 huggingface dataset:
English: Movymia cartridge and pen pack: 1 Movymia cartridge packed in a plastic tray sealed with lid foil and packed in a carton and 1 Movymia Pen packed into a separate carton.
Danish: Movymia pakke med cylinderampul og pen: 1 Movymia cylinderampul pakket i en plastbakke, forseglet med lågfolie og pakket i en karton og 1 Movymia Pen pakket i en separat karton.
English: Before disposing of the Movymia Pen always remove the pen needle and the cartridge.
Danish: Før du bortskaffer Movymia Pen, skal du altid fjerne penkanylen og cylinderampullen.
English: Movymia must not be transferred to a syringe.
Danish: Movymia må ikke overføres til en injektionssprøjte.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLERAF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Preparing the pen for use - To ensure the correct administration of Movymia always read the Instructions for Use of Movymia Pen, which is included in the carton of the pen.
Danish: Klargøring af pennen til brug - Læs altid brugsanvisningen til Movymia Pen, som følger med i pennens karton, for at garantere korrekt administration af Movymia.
English: Each Movymia cartridge contains 28 doses of fixed 80 microlitres Movymia.
Danish: Hver Movymia cylinderampul indeholder 28 doser á fastsat 80 mikroliter Movymia.
English: Sodium acetate trihydrate Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Danish: Natriumacetat-trihydrat Saltsyre (til pH-justering) Natriumhydroxid (til pH-justering) Vand til injektionsvæske
English: Each cartridge contains 2.4 mL of solution, enough for 28 doses.
Danish: Hver cylinderampul indeholder 2,4 ml opløsning, svarende til 28 doser.
English: The incidence of vertebral fractures was assessed in 448 placebo and 444 teriparatide patients who had baseline and follow-up spine radiographs.
Danish: Forkortelser: N = antal patienter randomiseret til hver behandlingsgruppe; KI = konfidensinterval Hyppigheden af vertebrale frakturer blev vurderet hos 448 placebo- og 444 teriparatid-patienter, der havde fået taget røntgenbillede af rygsøjlen ved baseline og som opfølgning.
English: Administration using the Movymia Pen
Danish: Administration ved hjælp af Movymia Pen
English: You should inject Movymia shortly after you take the pen with inserted cartridge out of the refrigerator.
Danish: Giv Movymia-injektionen umiddelbart efter pennen med cylinderampullen isat tages ud af køleskabet.
English: Glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, water for injections, hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).
Danish: Eddikesyre, natriumacetat-trihydrat, mannitol, metacresol, vand til injektionsvæske, saltsyre (til pHjustering) og natriumhydroxid (til pH-justering).
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om produktet findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: The date of first injection should also be recorded on the outer carton of Movymia (see the provided space on the box: {First use:}) (see section 3.
Danish: Datoen for den første injektion skal også registreres på Movymias yderpakning (se det dertil beregnede felt på kartonen: {Første anvendelse:}) (se afsnit 3).
English: A significant reduction in the incidence of hip fractures has not been demonstrated.
Danish: Der blev ikke påvist nogen signifikant effekt på hyppigheden af frakturer.
English: Your doctor may advise you to take Movymia with calcium and vitamin D. Your doctor will tell you how much you should take each day.
Danish: Deres læge vil muligvis anbefale, at De tager Movymia sammen med calcium og D-vitamin.
English: - The other ingredients are: glacial acetic acid, mannitol, metacresol, sodium acetate trihydrate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
Danish: - Øvrige indholdsstoffer: Eddikesyre, mannitol, metacresol og natriumacetat-trihydrat, saltsyre (til pH-justering), natriumhydroxid (til pH-justering), vand til injektionsvæsker.
English: Removing the pen needle
Danish: Fjernelse af penkanylen
English: The expiry date on the cartridge label must always be checked before inserting the cartridge into Movymia Pen.
Danish: Tjek altid cylinderampullens udløbsdato, inden den indsættes i Movymia Pen.
English: Women of childbearing potential should use effective methods of contraception during use of teriparatide.
Danish: Kvinder i den fertile alder bør anvende en sikker metode præventionsmetode under behandling med teriparatid.
English: Movymia is used to treat osteoporosis in adults.
Danish: Movymia anvendes til behandling af knogleskørhed hos voksne.
English: • increase in blood uric acid level • increase in an enzyme called alkaline phosphatase.
Danish: • stigning i et enzym ved navn basisk fosfatase
English: • Carefully attach the outer needle cap on the pen needle.
Danish: • Sæt forsigtigt den ydre nålehætte fast på penkanylen.
English: Instructions for use Movymia Pen
Danish: Brugsanvisning Movymia Pen
English: Teriparatide has been administered in single doses of up to 100 micrograms and in repeated doses of up to 60 micrograms/day for 6 weeks.
Danish: Teriparatid blev administreret i enkeltdoser på op til 100 mikrogram samt i gentagne doser på op til 60 mikrogram/dag i 6 uger.De bivirkninger, som kan forventes ved overdosering, er forsinket hyperkalcæmi og risiko for ortostatisk hypotension.
English: Movymia should not be used in growing adults.
Danish: Movymia må ikke bruges af patienter, der stadig vokser.
English: Movymia cartridges are designed to be used only with the Movymia Pen reusable, multidose delivery system and compatible pen needles.
Danish: Movymia cylinderampuller er kun beregnet til brug med det genanvendelige Movymia pen-flerdosisadministrationssystem til og kanyler kompatible med pennen.
English: How to use Movymia
Danish: Sådan skal De bruge Movymia
English: Tel: + 356 21337008
Danish: PharmaMt Tel: + 356 21337008
English: Each dose of 80 microliters contains 20 micrograms of teriparatide.
Danish: Hver dosis af 80 mikroliter indeholder 20 mikrogram teriparatid.
English: The date of first injection should also be written on the outer carton of Movymia (see the provided space on the box: {First use:}).
Danish: Datoen for den første injektion skal desuden skrives på Movymias yderpakning (se det dertil beregnede felt på kartonen: {Første anvendelse:}).
English: OUTER CARTON FOR CARTRIDGE
Danish: YDERKARTON TIL CYLINDERAMPUL
English: Each dose of 80 microliters contains 20 micrograms of teriparatide*.
Danish: Hver dosis på 80 mikroliter indeholder 20 mikrogram teriparatid*.
English: • if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness.
Danish: Kontakt lægen, før De tager Movymia: Hvis De lider af vedvarende kvalme, opkastning, forstoppelse, nedsat energi eller muskelsvaghed.
English: Read the patient information leaflet for Movymia cartridge provided separately.
Danish: Læs indlægssedlen til Movymia cylinderampullen, der leveres separat.
English: At baseline, the postmenopausal women had a mean age of 61 years, mean lumbar spine 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 T score of −2.2, median prednisone equivalent dose of 10 mg/day, and 24% had one or more radiographic vertebral fractures.
Danish: Ved baseline havde de postmenopausale kvinder en gennemsnitsalder på 61 år, en gennemsnitlig T-score på -2,7 for BMD i lænderygsøjlen, en middel prednisondosis ækvivalent med 7,5 mg dagligt og 34 % havde en eller flere vertebrale frakturer.
English: Movymia 20 micrograms/80 microliters solution for injection: 1 or 3 cartridges.
Danish: Movymia 20 mikrogram/80 mikloliter injektionsvæske, opløsning: 1 eller 3 cylinderampuller.
English: F: Attach a new pen needle as follows:
Danish: F: Fastgør en ny kanyle i pennen således: • Træk folien af.
English: b p≤0.001 compared with placebo.
Danish: p≤0.001 sammenlignet med placebo Der er ikke set en signifikant nedsættelse af hyppigheden af hoftefrakturer.
English: Movymia is supplied in a cartridge.
Danish: Movymia leveres i en cylinderampul.
English: Not applicable in case of cartridge and pen pack.}
Danish: Ikke relevant for pakke med cylinderampul og pen.}
English: Movymia cartridge and pen
Danish: Movymia cylinderampul og Pen
English: What Movymia looks like and contents of the pack Movymia is a colourless and clear solution.
Danish: Movymia er en farveløs og klar opløsning.
English: Movymia cartridge and pen pack:
Danish: Movymia pakke med cylinderampul og pen:
English: What Movymia is and what it is used for What you need to know before you use Movymia How to use Movymia
Danish: Det skal De vide, før De begynder at bruge Movymia Sådan skal De bruge Movymia Bivirkninger
English: LID FOIL
Danish: FOLIELÅG
English: 1 cartridge 3 cartridges
Danish: 1 cylinderampul 3 cylinderampuller
English: Follow the instructions every time you insert a new Movymia cartridge into your Movymia Pen.
Danish: Klargøring af pennen - Første brug/udskiftning af cylinderampuller Følg vejledningen, hver gang du indsætter en ny Movymia cylinderampul i din Movymia Pen.
English: STADA M&D SRL Tel: + 40 213160640
Danish: Tel: + 40 213160640
English: Movymia is contraindicated for use during breast-feeding.
Danish: Amning Movymia er kontraindiceret ved amning.
English: Movymia cartridge
Danish: Eddikesyre Mannitol Metacresol
English: Movymia 20 micrograms/80 microliters solution for injection Teriparatide
Danish: Movymia 20 mikrogram/80 mikroliter injektionsvæske, opløsning Teriparatid
English: Movymia 20 micrograms/80 microliters solution for injection teriparatide
Danish: Movymia 20 mikrogram/80 mikroliter injektionsvæske, opløsning teriparatid
English: Do not use Movymia if solid particles appear or if the solution is cloudy or coloured.
Danish: Movymia må ikke anvendes, hvis opløsningen er uklar, farvet eller indeholder partikler.
English: Movymia 20 mcg/80 mcL injection teriparatide
Danish: Movymia 20 mikrog/80 mikrol, injektionsvæske teriparatid s.c.
English: Movymia 20 micrograms/80 microliters solution for injection
Danish: Movymia 20 mikrogram/80 mikroliter injektionsvæske, opløsning.
English: If you use more Movymia than you should
Danish: Hvis De har brugt for meget Movymia
English: ANNEX III CONDITIONS OF THE MARKETING AUTHORISATIONS
Danish: BILAG III BETINGELSER FOR MARKEDSFØRINGSTILLADELSERNE
English: For the suspension to be lifted the Marketing Authorisation Holders would need to provide the National Competent Authorities with the following:
Danish: For at få suspenderingen ophævet skal indehaverne af markedsføringstilladelserne forelægge følgende for de kompetente nationale myndigheder:
English: Date of first authorisation: 21 February 2005 Date of latest renewal: 20 January 2010
Danish: Dato for første markedsføringstilladelse: 21. februar 2005 Dato for seneste fornyelse: 20. januar 2010
English: • this may cause the child to be tired or breathless
Danish: • Dette kan forårsage, at barnet blivet træt eller stakåndet
English: No human data on the effect of Truvada are available.
Danish: Der foreligger ingen humane data vedrørende virkningen af Truvada.
English: • weakness beginning in the hands and feet and moving up towards the trunk of the body
Danish: • svaghed, der begynder i hænder og fødder og bevæger sig op mod selve kroppen
English:  Tell your doctor if you are taking any of these medicines.
Danish:  Fortæl Deres læge, hvis De tager nogen af disse lægemidler.
English: Taking Truvada with other medicines that can damage your kidneys: it is especially important to tell your doctor if you are taking any of these medicines, including
Danish: Indtagelse af Truvada samtidig med andre lægemidler, som kan skade Deres nyrer: Det er specielt vigtigt at fortælle Deres læge, hvis De tager nogen af disse lægemidler, herunder
English: • Additional risk minimisation measures
Danish: • Yderligere risikominimerende foranstaltninger
English: Therefore, the same problems may be seen if Truvada is administered with a third nucleoside analogue.
Danish: De samme problemer kan derfor muligvis optræde, hvis Truvada administreres sammen med en tredje nukleosidanalog.
English: • Talk to your doctor if you are intolerant to lactose (see Truvada contains lactose later in this section).
Danish: • Tal med Deres læge, hvis De ikke kan tåle lactose (se Truvada indeholder lactose senere i dette afsnit).
English: Years living with study partner Years aware of discordant status
Danish: Gift med studiepartner Antal år levet sammen med studiepartner Antal år klar over diskordant status
English: and once daily as “q.d.”).
Danish: „b.i.d.“, og en gang dagligt som „q.d.“).
English: Truvada with food and drink
Danish: Brug af Truvada sammen med mad og drikke
English: • Although there are limited clinical data on the use of Truvada in pregnant women, it is not usually used unless absolutely necessary.
Danish: • Selvom der foreligger begrænsede kliniske data om brug af Truvada hos gravide, anvendes Truvada normalt ikke, medmindre det er absolut nødvendigt.
English: o Get tested for other sexually transmitted infections such as syphilis and gonorrhoea.
Danish: o Bliv testet for andre seksuelt overførbare infektioner, såsom syfilis og gonorré.
English: In order to optimise the absorption of tenofovir, it is recommended that Truvada should preferably be taken with food.
Danish: For at optimere tenofovirs absorption anbefales det, at Truvada helst tages sammen med mad.
English: • If you have hepatitis B, it is especially important not to stop your Truvada treatment without talking to your doctor first.
Danish: • Hvis De har hepatitis B, er det særlig vigtigt ikke at ophøre med behandlingen med Truvada uden først at konsultere Deres læge.
English: • Whenever possible, Truvada should be taken with food.
Danish: • Truvada skal så vidt muligt tages sammen med mad.
English: o Do not share or re-use needles or other injection or drug equipment.
Danish: o Lad være med at dele eller genbruge nåle og andet injektions- eller lægemiddeludstyr.
English: • Reminder of the key safety information regarding the use of Truvada for PrEP in adults and adolescents
Danish: • Påmindelse om de vigtigste sikkerhedsoplysninger omkring brugen af Truvada til PrEP hos voksne og unge.
English: Truvada P-valuea, b mITT Analysis
Danish: Truvada P-værdia, b mITT-Analyse
English: The most frequent adverse reaction reported in the Truvada group in the iPrEx study was headache (1%).
Danish: Den hyppigste bivirkning i Truvada-gruppen i iPrEx-studiet var hovedpine (1%).
English: • Know your hepatitis B virus (HBV) infection status before starting Truvada.
Danish: • Kend Deres status for hepatitis B virus (HBV)-infektion inden De begynder at tage Truvada.
English: • If you think you were infected with HIV, tell your doctor straight away.
Danish: • Hvis De mener, at De blev smittet med HIV, skal De straks fortælle Deres læge om det.
English: Table 2 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “b.i.d.”
Danish: nedenfor (stigning er angivet som „↑“, fald som „↓“, ingen ændring som „↔“, to gange dagligt som
English: Number with Tenofovir Detected/Total Samples (%)
Danish: Antal med Detekteret Tenofovir/ Samlet Prøveantal (%)
English: • Children given emtricitabine very commonly experienced changes in skin colour including
Danish: • Hos børn, der får emtricitabin, er det meget almindeligt at opleve ændringer i hudfarven, herunder
English: • If you are being treated for HIV infection your doctor will prescribe Truvada with other antiretroviral medicines.
Danish: • Hvis De bliver behandlet for HIV-infektion vil Deres læge ordinere Truvada sammen med andre antiretrovirale lægemidler.
English: EU/1/04/305/001 30 film-coated tablets EU/1/04/305/002 90 (3 x 30) film-coated tablets
Danish: EU/1/04/305/001 30 filmovertrukne tabletter EU/1/04/305/001 90 (3 x 30) filmovertrukne tabletter
English: If you have taken Truvada during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: Hvis De har taget Truvada under Deres graviditet, kan lægen anmode om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
English: If you accidentally take more than the recommended dose of Truvada, contact your doctor or nearest emergency department for advice.
Danish: Hvis De ved et uheld tager mere end den anbefalede dosis Truvada, skal De kontakte lægen eller den nærmeste skadestue for at få råd.
English: Truvada should only be used in individuals with creatinine clearance (CrCl) < 80 mL/min if the potential benefits are considered to outweigh the potential risks.
Danish: Truvada bør kun anvendes hos personer med kreatininclearance (CrCl) <80 ml/min, hvis de potentielle fordele anses for at opveje de potentielle risici.
English: Table 3: Tabulated summary of adverse reactions associated with the individual components of Truvada based on clinical study and post-marketing experience
Danish: Tabel 3: Resumé af bivirkninger forbundet med de individuelle komponenter af Truvada baseret på erfaringer fra kliniske studier og efter markedsføring
English: • The importance of regular monitoring of renal function during Truvada therapy
Danish: • Vigtigheden af regelmæssig monitorering af nyrefunktionen under Truvada-behandling
English: which may be allergic reactions, itching, changes in skin colour including darkening of the skin in patches
Danish: som kan være allergiske reaktioner, kløe, ændringer i hudfarven, herunder pletvis mørkfarvning af huden
English: Individuals over the age of 65 years are more likely to have decreased renal function, therefore caution should be exercised when administering Truvada to older people.
Danish: Da det er mere sandsynligt, at personer over 65 år har nedsat nyrefunktion, skal der udvises forsigtighed ved administration af Truvada til ældre mennesker.
English:  If you notice these or any symptoms of inflammation or infection, get medical help immediately.
Danish:  Hvis De ser disse eller andre symptomer på inflammation eller infektion, skal De straks søge læge.
English: • If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of therapy with Truvada to you and your child.
Danish: • Hvis De bliver gravid eller planlægger at blive gravid, skal De kontakte Deres læge for at drøfte de potentielle fordele og risici, som behandling med Truvada indebærer for Dem og Deres barn.
English: Table 2: Interactions between Truvada or its individual component(s) and other medicinal products
Danish: Tabel 2: Interaktion mellem Truvada eller dets individuelle komponent(er) og andre lægemidler
English: Truvada is not always effective in preventing the acquisition of HIV-1.
Danish: Truvada er ikke altid effektivt med hensyn til at forebygge smitte med HIV 1.
English: Truvada is not recommended if you have severe kidney disease or are on dialysis.
Danish: Truvada anbefales ikke, hvis De lider af svære nyresygdomme eller er i dialyse.
English: Truvada should not be given to adolescents with existing kidney problems.
Danish: Truvada bør ikke anvendes til unge med eksisterende nyreproblemer.
English: People who do have HIV must take Truvada in combination with other drugs.
Danish: Personer, der har HIV, skal tage Truvada sammen med andre lægemidler.
English: In addition, the clinical response to treatment should be closely monitored in patients receiving Truvada at a prolonged dosing interval.
Danish: Det kliniske respons på behandlingen bør endvidere monitoreres nøje hos patienter, der får Truvada med et forlænget doseringsinterval.
English: Truvada should be initiated by a physician experienced in the management of HIV infection.
Danish: Truvada skal initieres af en læge med erfaring i behandlingen af HIV-infektion.
English: If you have kidney problems, your doctor may advise you to stop taking Truvada or, if you already have HIV, to take Truvada less frequently.
Danish: Hvis De har nyreproblemer, vil Deres læge muligvis råde Dem til at holde op med at tage Truvada, eller, hvis De er inficeret med HIV, til at tage Truvada mindre hyppigt.
English: Truvada can cause dizziness.
Danish: Truvada kan forårsage svimmelhed.
English: The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Danish: Silicagel-tørremidlet er i en separat pose eller beholder og må ikke sluges.
English: Risk Estimate for HIV-1 Protection: Detection Versus No Detection of Tenofovir
Danish: Risikoestimat for HIV 1Beskyttelse: Detektering af vs. ingen detektering af Tenofovir
English: • rashes (including red spots or blotches sometimes with blistering and swelling of the skin),
Danish: • udslæt (inklusive røde pletter eller skjolder, undertiden med blærer eller hævelse af huden),
English: Truvada should only be used for pre-exposure prophylaxis as part of an overall HIV-1 infection prevention strategy including the use of other HIV-1 prevention measures (e.g. consistent and correct condom use, knowledge of HIV-1 status, regular testing for other sexually transmitted infections).
Danish: Truvada bør kun bruges som profylakse før eksponering i forbindelse med en samlet strategi for forebyggelse af HIV 1-infektion, herunder brug af andre HIV 1-forebyggende foranstaltninger (f.eks. konsekvent og korrekt brug af kondom, viden om HIV 1-status, regelmæssig test for andre seksuelt overførte infektioner).
English: Adherence Substudy Participantsb Placebo
Danish: Deltagere i Adhærensdelstudietb Placebo
English: Truvada is not for use in children under 12 years of age.
Danish: Truvada må ikke anvendes til børn under 12 år.
English: (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to
Danish: Frekvens er defineret som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100) eller sjælden (≥ 1/10.000 til < 1/1.000).
English: • Adults: one tablet each day, whenever possible with food.
Danish: • Voksne: En tablet om dagen, så vidt muligt sammen med mad.
English: Truvada can only help reduce your risk of getting HIV before you are infected.
Danish: Truvada kan kun hjælpe med at nedsætte Deres risiko for at få HIV, før De bliver smittet.
English: Administration of Truvada with food resulted in a delay of approximately three quarters of an hour in reaching maximum tenofovir concentrations and increases in tenofovir AUC and Cmax of approximately 35% and 15%, respectively, when administered with a high fat or light meal, compared to administration in the fasted state.
Danish: Administration af Truvada sammen med mad gav en forsinkelse på cirka tre kvarter i forhold til opnåelse af maksimale tenofovirkoncentration og en forøgelse i tenofovirs AUC og Cmax med henholdsvis ca. 35% og 15%, når det blev administreret sammen med et let måltid eller et måltid med højt fedtindhold, sammenlignet med administration i fastende tilstand.
English: If clinical symptoms consistent with acute viral infection are present and recent (< 1 month) exposures to HIV-1 are suspected, use of Truvada should be delayed for at least one month and HIV-1 status reconfirmed before starting Truvada for pre-exposure prophylaxis.
Danish: Hvis der findes kliniske symptomer svarende til akut virusinfektion, og der er mistanke om nylige (< 1 måned) eksponeringer for HIV 1, bør brugen af Truvada udsættes mindst en måned og HIV 1status bekræftes før påbegyndelse af Truvada som profylakse før eksponering.