FrancophonIA/ELRC3.0 huggingface dataset:
English: Baseline values are means, changes from baseline at week 56 are estimated means (leastsquares) and treatment contrasts at week 56 are estimated treatment differences.
Danish: Baseline-værdierne er gennemsnitlige, ændringer fra baseline ved uge 56 er anslåede gennemsnit (mindste kvadraters metode), og behandlingskontraster ved uge 56 er anslåede behandlingsforskelle.
English: No dose adjustment is recommended for patients with mild or moderate hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat leverfunktion.
English: After first use: Store below 30°C or store in a refrigerator (2°C-8°C).
Danish: Efter ibrugtagning: Opbevares ved temperaturer under 30°C eller opbevares i køleskab (2°C - 8°C).
English: Lisinopril median tmax was delayed from 6 h to 8 h with liraglutide.
Danish: Medianværdien for tmaks for lisinopril sammen med liraglutid blev forsinket fra 6 timer til 8 timer.
English: Also, in these patients documented symptomatic hypoglycaemia was reported by 43.6% of patients treated with Saxenda and in 27.3% of patients treated with placebo.
Danish: Der blev rapporteret dokumenteret symptomatisk hypoglykæmi hos 43,6% af de patienter, der fik Saxenda, og hos 27,3% af de patienter, der fik placebo.
English: In a clinical trial in overweight or obese patients with type 2 diabetes mellitus treated with Saxenda in combination with diet and exercise, severe hypoglycaemia (requiring third party assistance) was reported by 0.7% of patients treated with Saxenda and only in patients concomitantly treated with sulfonylurea.
Danish: I kliniske studier med overvægtige og adipøse patienter med type 2-diabetes mellitus, der blev behandlet med Saxenda kombineret med diæt og motion, blev der rapporteret alvorlig hypoglykæmi (som krævede assistance fra tredjepart) hos 0,7% af de patienter, der fik Saxenda, og kun af patienter, som samtidig fik sulfonylurinstof.
English: Rare: may affect up to 1 in 1,000 people
Danish: Sjældne: kan forekomme hos op til 1 ud af 1.000 behandlede
English: If no drop appears, repeat step 2 ‘Check the flow' up to 6 times.
Danish: Hvis der ikke kommer en dråbe til syne, gentages trin 2 ‘Klargøring'
English: feeling very hungry, changes in vision, feeling sleepy, feeling weak, being nervous, being anxious, confusion, difficulty concentrating and shaking (tremor).
Danish: usædvanlig stor sultfornemmelse, synsforstyrrelser, døsighed, svaghed, nervøsitet, uro,
English: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients may develop anti-liraglutide antibodies following treatment with liraglutide.
Danish: Patienter kan udvikle anti-liraglutid-antistoffer efter behandling med liraglutid, hvilket er konsistent med de potentielt immunogene egenskaber ved lægemidler indeholdende proteiner og peptider.
English: Neonatal growth was reduced in rats while exposed to liraglutide and persisted in the post-weaning period in the high dose group.
Danish: Den neonatale vækst blev reduceret hos rotter, der blev eksponeret for liraglutid.
English: If you have thyroid disease, including thyroid nodules and enlargement of the thyroid gland, consult your doctor.
Danish: Hvis du har sygdomme i skjoldbruskkirtlen, herunder knuder i skjoldbruskkirtlen eller forstørret skjoldbruskkirtel, skal du kontakte din læge.
English: Table 4 Trial 1: Changes from baseline in body weight, glycaemia and cardiometabolic parameters at week 160
Danish: Tabel 4 Studie 1: Ændringer fra baseline i legemsvægt, glykæmi og kardiometaboliske parametre ved uge 160
English: For body weight, HbA1c, FPG, blood pressure and waist circumference, baseline values are means, changes from baseline at week 160 are estimated means (least-squares) and treatment contrasts at week
Danish: For legemsvægt, HbA1c, FPG, blodtryk og livvidde er baseline-værdierne gennemsnitlige, ændringer fra baseline ved uge 160 er estimerede gennemsnit (mindste kvadraters metode), og behandlingskontraster ved uge 160 er estimerede behandlingsforskelle.
English: This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.
Danish: Dette kan forhindre tilstopning af nålene, urenheder, infektion, at opløsningen siver ud og upræcis dosering.
English: Hypoglycaemia in patients without type 2 diabetes mellitus
Danish: Hypoglykæmi hos patienter uden type 2-diabetes mellitus
English: For body weight, HbA1c, FPG, blood pressure and waist circumference, baseline values are means, changes from baseline at week 56 are estimated means (least-squares) and treatment contrasts at week 56
Danish: For legemsvægt, HbA1c, FPG, blodtryk og livvidde er baseline-værdierne gennemsnitlige, ændringer fra baseline ved uge 56 er anslåede gennemsnit (mindste kvadraters metode), og behandlingskontraster ved uge 56 er anslåede behandlingsforskelle.
English: • Turn the dose selector until the dose counter shows your dose
Danish: • Drej dosisvælgeren indtil dosistælleren viser din dosis (0,6 mg,
English: • Acute kidney failure.
Danish: • Akut nyresvigt.
English: This may prevent blocked needles, contamination, infection and inaccurate dosing.
Danish: Det kan forhindre tilstopning af nålene, urenheder, infektion og upræcis dosering.
English: 2 Check the flow • Before your first injection with each new pen, check the flow.
Danish: 2 Kontrol af gennemløb • Kontrollér altid gennemløbet før du tager en ny pen i brug.
English: Table 6 Trial 3: Changes from baseline in body weight and Apnoea-Hypopnoea Index at week
Danish: Tabel 6 Studie 3: Ændringer fra baseline i legemsvægt og apnø-hypopnø-indeks ved uge 32
English: • Do not wash, soak or lubricate your pen.
Danish: • Pennen må ikke vaskes, sættes i blød eller smøres.
English: For the proportions of patients losing ≥5/>10% body weight, estimated odds ratios are presented.
Danish: For andelene af patienter med et vægttab på ≥5/>10% er de anslåede odds-frekvenser angivet.
English: Hypoglycaemia in patients with type 2 diabetes mellitus treated with insulin
Danish: Hypoglykæmi hos patienter med type 2-diabetes mellitus i behandling med insulin
English: • Feeling generally unwell
Danish: • Generel utilpashed
English: Dose injected
Danish: Injiceret dosis
English: and >10% weight loss with liraglutide than with placebo (tables 3-5).
Danish: På tværs af studiepopulationerne opnåede en større andel af patienterne ≥5% og >10% vægttab med liraglutid end med placebo (tabel 3-5).
English: Acute renal failure Renal impairment
Danish: Akut nyresvigt Nedsat nyrefunktion
English: If you use more Saxenda than you should, talk to a doctor or go to a hospital straight away.
Danish: Hvis du har brugt for meget Saxenda, skal du straks kontakte din læge eller skadestuen.
English: Week 5 onwards
Danish: Uge 5 og fremefter
English: Early responders were defined as patients who achieved ≥5% weight loss after 12 weeks on treatment dose of liraglutide (4 weeks of dose escalation and 12 weeks on treatment dose).
Danish: 12 uger med en behandlingsdosis af liraglutid (4 uger med dosisstigning og 12 uger med behandlingsdosis).
English: One pre-filled pen contains 18 mg liraglutide in 3 ml.
Danish: En fyldt pen indeholder 18 mg liraglutid i 3 ml.
English: • Loss of fluids (dehydration).
Danish: • Væsketab (dehydrering).
English: Table 3 Trial 1: Changes from baseline in body weight, glycaemia and cardiometabolic parameters at week 56
Danish: Tabel 3 Studie 1: Ændringer fra baseline i legemsvægt, glykæmi og kardiometaboliske parametre ved uge 56
English: Cases of inflammation of the pancreas (pancreatitis) have been reported uncommonly in patients using Saxenda.
Danish: Der er indberettet om tilfælde af betændelse i bugspytkirtlen (pankreatitis) hos patienter der bruger Saxenda, med hyppigheden ”ikke almindelig”.
English: Saxenda is not recommended for use in patients with severe renal impairment (creatinine clearance <30 ml/min) including patients with end-stage renal disease (see sections 4.4, 4.8 and 5.2).
Danish: Saxenda anbefales ikke til patienter med svært nedsat nyrefunktion (kreatinin-clearance <30 ml/min), inklusive patienter med terminal nyreinsufficiens (se pkt.
English: (0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg).
Danish: 1,2 mg, 1,8 mg, 2,4 mg eller 3,0 mg).
English: Package leaflet: Information for the patient Saxenda 6 mg/ml solution for injection in pre-filled pen liraglutide
Danish: Indlægsseddel: Information til patienten Saxenda 6 mg/ml injektionsvæske, opløsning, i fyldt pen liraglutid
English: Start by checking your pen to make sure that it contains Saxenda 6 mg/ml,
Danish: Begynd med at kontrollere pennen for at sikre dig, at den indeholder Saxenda 6 mg/ml, og se derefter på nedenstående illustrationer, så du kan lære de forskellige dele af pennen og nålen at kende.
English: Hypersensitivity to liraglutide or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for liraglutid eller over for et eller flere af hjælpestofferne anført i pkt.
English: This may be due to feeling sick (nausea), being sick (vomiting) and diarrhoea.
Danish: Det kan skyldes kvalme, opkastning og diarré.
English: Hypoglycaemia in patients with type 2 diabetes mellitus
Danish: Hypoglykæmi hos patienter med type 2-diabetes mellitus
English: How to use Saxenda
Danish: Sådan skal du bruge Saxenda
English: • Press and hold down the dose button until the dose counter shows 0.
Danish: • Tryk på dosisknappen, og hold den nede, indtil dosistælleren viser 0.
English: 3.0 mg once a day
Danish: 3,0 mg én gang dagligt
English: Common: may affect up to 1 in 10 people
Danish: Almindelige: kan forekomme hos op til 1 ud af 10 behandlede
English: 0.6 mg once a day
Danish: 0,6 mg én gang dagligt
English: 2.4 mg left
Danish: 2,4 mg tilbage
English: 1.8 mg once a day
Danish: 1,8 mg én gang dagligt
English: Malaise
Danish: Træthed
English: 2.4 mg once a day
Danish: 2,4 mg én gang dagligt
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelige: kan forekomme hos op til 1 ud af 100 behandlede
English: Symptoms of hypoglycaemic events were reported by 1.6 % of patients treated with Saxenda and 1.1% of patients treated with placebo; however, these events were not confirmed by blood glucose measurements.
Danish: Symptomer på hypoglykæmiske hændelser blev rapporteret hos 1,6% af de patienter, der fik Saxenda, og hos 1,1% af de patienter, der fik placebo.
English: For patients who experience a clinically relevant sustained increase in resting heart rate, treatment with liraglutide should be discontinued.
Danish: Liraglutid skal seponeres hos patienter, der oplever en klinisk relevant vedvarende stigning i hjertefrekvensen i hvile.
English: This is because it is not known if Saxenda passes into breast milk.
Danish: Du må ikke amme, hvis du bruger Saxenda, da det er ukendt, om Saxenda udskilles i modermælken.
English: • Keep the needle in your skin after the dose counter has returned to 0
Danish: • Lad nålen forblive under huden, når dosistælleren igen viser 0, og tæl langsomt til 6.
English: Press and hold in the dose button until the dose counter returns to 0.
Danish: Tryk på dosisknappen, og hold den nede, indtil dosistælleren igen viser 0.
English: Liraglutide did not change the overall exposure of griseofulvin following administration of a single dose of griseofulvin 500 mg. Griseofulvin Cmax increased by 37% while median tmax did not change.
Danish: Liraglutid ændrede ikke den overordnede eksponering af griseofulvin efter administration af én dosis på 500 mg griseofulvin.
English: Loss of fluid and dehydration
Danish: Væsketab og væskemangel (dehydrering)
English: Paracetamol (Acetaminophen)
Danish: Paracetamol
English: It contains 18 mg of liraglutide and delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg.
Danish: Den indeholder 18 mg liraglutid og giver doser a 0,6 mg, 1,2 mg, 1,8 mg, 2,4 mg og 3,0 mg.
English: Mean change at week 32, % (95% CI) Mean change at week 32, kg (95% CI)
Danish: Gennemsnitlig ændring ved uge 32, kg (95 % CI)
English: If you have kidney disease or are on dialysis, consult your doctor.
Danish: Kontakt din læge, hvis du har nyresygdomme eller er i dialyse.
English: 1.2 mg once a day
Danish: 1,2 mg én gang dagligt
English: 3 Select your dose
Danish: 3 Indstilling af dosis
English: Digoxin median tmax was delayed from 1 h to 1.5 h. No dose adjustment of digoxin is required based on these results.
Danish: Medianværdien for tmaks for digoxin blev forsinket fra 1 time til 1,5 time.
English: The absorption of liraglutide following subcutaneous administration was slow, reaching maximum concentration approximately 11 hours post dosing.
Danish: Liraglutid blev absorberet langsomt efter subkutan administration.
English: One pre-filled pen contains 18 mg liraglutide.
Danish: En fyldt pen indeholder 18 mg liraglutid.
English: In patients treated with GLP-1 receptor agonists, there have been reports of acute renal failure.
Danish: Fra patienter, behandlet med GLP-1-receptoragonister, er der blevet indrapporteret tegn og symptomer på dehydrering, inklusive nedsat nyrefunktion og akut nyresvigt.
English: Saxenda is a weight loss medicine that contains the active substance liraglutide.
Danish: Saxenda er et lægemiddel til at opnå vægttab.
English: Mean change at week 56, % (95% CI) Mean change at week 56, kg (95% CI)
Danish: Gennemsnitlig ændring ved uge 56, kg (95 % CI)
English: Proportion of patients losing ≥5% body weight at week 56, % (95% CI)
Danish: Andel af patienter med vægttab ≥ 5 % ved uge 56, % (95 % CI)
English: The safety and efficacy of liraglutide for weight management have not been established in patients: - aged 75 years or more, - treated with other products for weight management, - with obesity secondary to endocrinological or eating disorders or to treatment with medicinal products that may cause weight gain, - with severe renal impairment, - with severe hepatic impairment.
Danish: - der er i behandling med andre præparater til vægtkontrol - med adipositas som en følge af en endokrin sygdom eller spiseforstyrrelse, eller som er i behandling med et præparat der kan forårsage vægtøgning.
English: Proportion of patients losing >10% body weight at week 56, % (95% CI)
Danish: Andel af patienter med vægttab > 10 % tab af legemsvægt ved uge 56, % (95 % CI)
English: Mean change at week 160, % (95% CI) Mean change at week 160, kg (95% CI)
Danish: Gennemsnitlig ændring ved uge 160, kg (95% CI)
English: Each pen contains 3 ml solution and is able to deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg.
Danish: Hver pen indeholder 3 ml opløsning, og kan give doser på 0,6 mg, 1,2 mg, 1,8 mg, 2,4 mg og 3,0 mg.
English: Saxenda 6 mg/ml solution for injection in pre-filled pen
Danish: Saxenda 6 mg/ml injektionsvæske, opløsning, i fyldt pen
English: Injection site reactions Asthenia Fatigue
Danish: Reaktioner på injektionsstedet Asteni
English: Across the trial populations, greater proportions of the patients achieved ≥5%
Danish: De der tidligt opnåede en effekt, blev defineret som patienter, der opnåede et vægttab på ≥5% efter
English: Nausea Vomiting Diarrhoea Constipation
Danish: Injektionsvæske, opløsning
English: Pen label
Danish: Klargøringssymbol
English: Each pen contains 3 ml solution and is able to deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg
Danish: Hver pen indeholder 3 ml injektionsvæske, opløsning, og kan give doser på 0,6 mg, 1,2 mg, 1,8 mg, 2,4 mg og 3,0 mg
English: Instructions on how to use Saxenda 6 mg/ml solution for injection in prefilled pen
Danish: Brugervejledning til Saxenda 6 mg/ml injektionsvæske, opløsning, i fyldt pen
English: If you have liver problems, consult your doctor.
Danish: Kontakt din læge, hvis du har leverproblemer.
English: If you use more Saxenda than you should
Danish: Hvis du har brugt for meget Saxenda
English: Saxenda 6 mg/ml solution for injection in pre-filled pen liraglutide
Danish: Saxenda 6 mg/ml injektionsvæske, opløsning, i fyldt pen liraglutid
English: Proportion of patients losing ≥5% body weight at week 32, % (95% CI) Proportion of patients losing >10% body weight at week 32 % (95% CI)
Danish: Andel af patienter med vægttab ≥5% ved uge 160, % (95% CI) Andel af patienter med vægttab >10% ved uge 160, % (95% CI)
English: Inflamed gall bladder and gallstones
Danish: Lever og galdeveje
English: Inflammation of the pancreas
Danish: Betændelse i bugspytkirtlen
English: SC use
Danish: Penhætte
English: • Delay in the emptying of the stomach
Danish: • Forsinket mavetømning
English: The frequency is not known.
Danish: Hyppigheden kendes ikke.
English: 31 May 2016 EMA/262389/2016
Danish: 31. maj 2016 EMA/262389/2016
English: However, firm conclusions could not be drawn as these studies did not use a control group.
Danish: Der kunne dog ikke drages endelige konklusioner, da disse undersøgelser ikke omfattede en kontrolgruppe.
English: Some of these combinations may be used in adults and adolescents over 12 years of age, some others may be used also in children over 4 years of age.
Danish: Nogle af disse kombinationer kan anvendes til voksne og børn over 12 år, mens andre kan anvendes til børn over 4 år.
English: Stomach complaints and nausea may occur.
Danish: Der kan forekomme mavegener og kvalme.
English: What are the HMPC conclusions on their medicinal uses?
Danish: Hvad er HMPC's konklusioner vedrørende den medicinske anvendelse?
English: Thymus vulgaris L. or Thymus zygis L., herba and Primula veris L. or Primula elatior (L.) Hill, radix
Danish: Thymus vulgaris L. eller Thymus zygis L., herba, og Primula veris L. eller Primula elatior (L.) Hill, radix
English: In some cases the solvent is then either partially or fully evaporated to obtain a soft or dry extract.
Danish: I nogle tilfælde fordampes opløsningsmidlet helt eller delvist, så der opnås et tørt eller et blødt ekstrakt.
English: Thyme is the common name for the aerial parts of the plants Thymus vulgaris L. or Thymus zygis L., and primula root is the common name for the underground parts of Primula veris L. or Primula elatior (L.) Hill.
Danish: Timian er fællesnavnet for de overjordiske dele af planterne Thymus vulgaris L. eller Thymus zygis L., og primularod er fællesnavnet for de underjordiske dele af Primula veris L. eller Primula elatior (L.) Hill.
English: The way thyme and primula root work is not fully known, but laboratory studies indicate that thyme may have an action against microbes and a muscle relaxant effect while primula root may increase production of sputum in the airways, thereby diluting phlegm and helping to bring it up.
Danish: Virkningsmekanismen for timian og primularod kendes ikke fuldstændigt, men på baggrund af laboratorieundersøgelser mener man, at timian kan have en antimikrobiel og muskelafslappende virkning, mens primularod kan øge produktionen af opspyt i luftvejene, hvorved slimen fortyndes og bliver lettere at hoste op.
English: Any applications for the licensing of medicines containing combinations of thyme and primula root have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder en kombination af timian og primularod, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: Information on the use and licensing of thyme and primula root medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om anvendelse og godkendelse af lægemidler, der indeholder timian og primularod, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: If symptoms last longer than one week during the use of the medicine for coughs associated with colds a doctor or a qualified health care practitioner should be consulted.
Danish: Hvis symptomerne varer længere end én uge under brug af lægemidlet til behandling af hoste i forbindelse med forkølelse, bør der søges råd hos en læge eller en kvalificeret sundhedsperson.
English: Further information on the HMPC assessment of thyme and primula root medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder timian og primularod, herunder detaljerede oplysninger om udvalgets konklusioner, findes under fanebladet "All documents" på det europæiske lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the risks associated with these thyme and primula root medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder timian og primularod, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Detailed instructions on how to take thyme and primula root medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger på, hvordan lægemidler med timian og primularod bør anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing thyme herb and primula root combinations.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder en kombination af timian og primularod.
English: Thyme and primula root
Danish: Timian og primularod
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of thyme and primula root as a combination.
Danish: Dette er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af timian og primularod i kombination.
English: Herbal medicines containing combinations of these thyme and primula root preparations are usually available in liquid or solid forms to be taken by mouth.
Danish: Plantelægemidler i disse tilberedninger med en kombination af timian og primularod fås normalt i flydende eller fast form til anvendelse gennem munden.
English: This summary is not intended to provide practical advice on how to use medicines containing combinations of thyme and primula root.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder en kombination af timian og primularod, skal anvendes.
English: In its assessment, the HMPC considered a number of clinical studies with thyme and primula root showing that these medicines help reduce coughs in adults.
Danish: HMPC har i sin vurdering lagt vægt på en række kliniske undersøgelser af timian og primularod, der viser, at disse plantelægemidler nedsætter hoste hos voksne.
English: Other information about thyme and primula root medicines
Danish: Andre oplysninger om lægemidler, der indeholder timian og primularod
English: What are the risks associated with thyme and primula root medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder timian og primularod?
English: The HMPC conclusions only cover combinations of certain thyme and primula root preparations which are obtained using a technique to extract compounds by putting the plant material in a solvent (such as ethanol or glycerol) to dissolve compounds and form a liquid extract.
Danish: HMPC's konklusioner omfatter kun visse tilberedninger af en kombination af timian og primularod, som fremstilles ved at udtrække stoffer fra plantematerialet i f.eks. ethanol eller glycerol.
English: How are thyme and primula root medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder timian og primularod, i EU?