FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
Danish: Lægemidler, der kan udløse hyperkaliæmi er kaliumholdige salterstatninger, kaliumbesparende diuretika, ACE-hæmmere, angiotensin IIreceptorantagonister, nonsteroide antiinflammatoriske lægemidler (NSAIDere, herunder selektive COX-2-hæmmere), heparin, immunosuppressiva (ciclosporin eller tacrolimus) og trimethoprim.
English: In preclinical studies, no effects of Tolura on male and female fertility were observed.
Danish: I prækliniske studier blev der ikke påvist nedsat fertilitet hos hunner eller hanner ved brug af telmisartan.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP
English: What Tolura looks like and contents of the pack Tolura 80 mg tablets are white to almost white, biconvex, capsule shape tablets.
Danish: Udseende og pakningsstørrelser Tolura 80 mg tabletter er hvide til næsten hvide, hvælvede, kapselformede tabletter.
English: When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy such as Tolura.
Danish: Man bør dog være opmærksom på, at der ved antihypertensiv behandling, som for eksempel med Tolura, lejlighedsvis kan forekomme svimmelhed eller døsighed.
English: - Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
Danish: - nedsat blodtilførsel til én eller til begge nyrer (nyrearteriestenose).
English: Eye disorders Rare:
Danish: Øjne Sjælden:
English: Tolura 40 mg tablets
Danish: Tolura 40 mg tabletter
English: The blood pressure lowering effects of two doses of telmisartan were assessed in 76 hypertensive, largely overweight patients aged 6 to < 18 years (body weight ≥ 20 kg and ≤ 120 kg, mean 74.6 kg), after taking telmisartan 1 mg/kg (n = 29 treated) or 2 mg/kg (n = 31 treated) over a four-week treatment period.
Danish: Den blodtrykssænkende virkning af henholdsvis telmisartan 1 mg/kg (n = 29) og 2 mg/kg (n = 31) blev undersøgt hos 76 hypertensive, stærkt overvægtige patienter i alderen 6 til <18 år over en fireugers behandlingsperiode.
English: Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may result in volume depletion and in a risk of hypotension when initiating therapy with telmisartan.
Danish: Der kan opstå volumendepletion og risiko for hypotension ved initiering af behandling med telmisartan, hvis patienten forudgående har modtaget behandling med høje doser af diuretika såsom furosemid (loop-diuretika) og hydrochlorthiazid (thiazid-diuretika).
English: Treatment: Telmisartan is not removed by haemodialysis.
Danish: Telmisartan kan ikke fjernes ved hæmodialyse.
English: Some patients may already benefit at a daily dose of 20 mg.
Danish: Hos nogle patienter kan blodtrykket kontrolleres tilfredsstillende med blot 20 mg én gang dagligt.
English: Concomitant use not recommended
Danish: Nedenstående kombinationer frarådes
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Second and third trimester of pregnancy (see sections 4.4 and 4.6) - Biliary obstructive disorders - Severe hepatic impairment
Danish: 6.1 - Andet og tredje trimester af graviditeten (se pkt.
English: ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on cardiovascular outcomes in 25620 patients aged 55 years or older with a history of coronary artery disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at risk for cardiovascular events.
Danish: Patienterne var 55 år eller ældre og havde en anamnese med koronararteriesygdom, apopleksi, transitorisk cerebral iskæmi (TCI), perifer arteriel sygdom eller diabetes mellitus type 2 med en organpåvirkning (f.eks. retinopati, venstre ventrikel hypertrofi, makro- eller mikroalbuminuri).
English: Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or antidepressants.
Danish: Desuden kan alkohol, barbiturater, morfinlignende smertestillende medicin, og medicin mod depression yderligere forværre et lavt blodtryk.
English: Tolura 20 mg tablets
Danish: Tolura 20 mg tabletter
English: Symptoms: The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia, dizziness, increase in serum creatinine, and acute renal failure have also been reported.
Danish: Bradykardi, svimmelhed, øget serumkreatinin og akut nyresvigt er også set.
English: Tolura 80 mg tablets
Danish: Tolura 80 mg tabletter
English: The use of angiotensin II receptor antagonists is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Danish: I andet og tredje trimester er behandling med angiotensin II-receptorantagonister kontraindiceret (se pkt.
English: Back pain (e.g. sciatica), muscle spasms, myalgia Arthralgia, pain in extremity, tendon pain (tendinitis like symptoms)
Danish: artralgi, smerter i ekstremiteter, senesmerter (tendinitislignende symptomer)
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Tolura til dig personligt.
English: Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Patienter, som planlægger graviditet, bør skifte til en alternativ antihypertensiv behandling, der er sikker at anvende for gravide, med mindre fortsat behandling med angiotensin II-receptorantagonist er påkrævet.
English: Tolura 40 mg tablets Telmisartan
Danish: Tolura 40 mg tabletter telmisartan
English: Tolura 40 mg tablets telmisartan
Danish: Tolura 40 mg tabletter Telmisartan
English: In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the co-administration of angiotensin II receptor antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Danish: Samtidig behandling med angiotensin II-receptorantagonister og stoffer, der hæmmer cyclooxygenasen kan medføre en yderligere svækkelse af nyrefunktionen hos nogle patienter, der har nedsat nyrefunktion (f.eks. dehydrerede patienter eller ældre patienter med nedsat nyrefunktion).
English: Tolura 80 mg tablets Telmisartan
Danish: Tolura 80 mg tabletter Telmisartan
English: Tolura 20 mg tablets telmisartan
Danish: Tolura 20 mg tabletter telmisartan
English: Chest pain, asthenia (weakness) Influenza-like illness
Danish: brystsmerter, asteni (træthed)
English: Gastrointestinal disorders Uncommon:
Danish: mundtørhed, gastrointestinalt ubehag, dysgeusi
English: Investigations Uncommon: Rare:
Danish: Lever og galdeveje Sjælden:
English: The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy (see section 4.4).
Danish: I første trimester frarådes behandling med angiotensin II-receptorantagonister (se pkt.
English: Patients with hepatic impairment
Danish: influenzalignende symptomer
English: FRI
Danish: LØ
English: SUN
Danish: TI
English: Posology
Danish: ÆSKE
English: London, 21 February 2008 Doc.
Danish: London, den 21. februar 2008 Dok.
English: International non-proprietary name (INN): somatropin
Danish: Internationalt fællesnavn (INN): somatropin
English: In total, the children received the medicine for up to ten years.
Danish: Børnene blev behandlet med lægemidlet i op til 10 år i alt.
English: This must be confirmed by chromosome analysis (DNA testing);
Danish: Dette skal bekræftes ved en kromosomanalyse (dna-test),
English: In addition, a benefit of the medicine in improving the child's psychological or social wellbeing had not been shown.
Danish: Det var heller ikke blevet påvist, at lægemidlet kunne forbedre barnets psykologiske eller sociale velbefindende.
English: The main measure of effectiveness was the increase in adult height.
Danish: Det primære mål for virkning var stigningen i voksenhøjde.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Danish: Brevet fra virksomheden, hvori EMEA underrettes om tilbagetrækningen af ansøgningen, kan ses her.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE APPLICATION FOR A CHANGE TO THE MARKETING AUTHORISATION for NUTROPINAQ
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM ÆNDRING AF MARKEDSFØRINGSTILLADELSEN for NUTROPINAQ
English: The company had requested a re-examination of the negative opinion, but this had not yet finished when the company withdrew.
Danish: Virksomheden havde anmodet om en revurdering af den negative udtalelse, men revurderingen var endnu ikke afsluttet, da virksomheden trak ansøgningen tilbage.
English: • when they fail to grow because of a lack of growth hormone;
Danish: • når de ikke vokser på grund af mangel på væksthormon,
English: It promotes growth during childhood and adolescence, and also acts on the way the body handles proteins, fat and carbohydrates.
Danish: Det fremmer væksten under barndommen og ungdommen og har også betydning for den måde, som proteiner, fedt og kulhydrater håndteres på i kroppen.
English: NutropinAq is already used to treat children in the following situations:
Danish: NutropinAq anvendes i forvejen til behandling af børn i følgende situationer:
English: What was NutropinAq expected to be used for?
Danish: Hvad forventedes NutropinAq anvendt til?
English: There are no consequences on the use of NutropinAq in the authorised indications, for which the balance of benefits and risks remains unchanged.
Danish: Det får ingen konsekvenser at anvende NutropinAq til de godkendte indikationer, for hvilke benefit/risk-forholdet forbliver uændret.
English: It is produced by a method known as ‘recombinant DNA technology': the hormone is made by a bacterium that has received a gene (DNA) that makes it able to produce human growth hormone.
Danish: Det fremstilles ved hjælp af en metode kaldet rekombinant dna-teknologi: Hormonet produceres af en bakterie, der har fået indsat et gen (dna), som gør den i stand til at producere humant væksthormon.
English: What were the major concerns of the CHMP?
Danish: Hvori bestod CHMP's vigtigste betænkeligheder?
English: • if they are short because of Turner syndrome (a rare genetic disorder affecting girls).
Danish: • hvis de er lave på grund af Turners syndrom, der er en sjælden genetisk sygdom, som rammer piger.
English: The deficiency can have started in adulthood or childhood, and needs to be confirmed by testing before treatment begins.
Danish: Væksthormonmanglen kan være debuteret i barndommen eller i voksenalderen og skal bekræftes gennem test, før behandlingen påbegyndes.
English: The active ingredient in NutropinAq, somatropin, is identical to the human growth hormone.
Danish: Det aktive stof i NutropinAq, somatropin, er identisk med det humane væksthormon.
English: It was to be used if all possible causes of the child's short height had been excluded, such as low growth hormone levels.
Danish: Det skulle have været anvendt, når alle mulige årsager til barnets lave højde, f.eks. lav mængde af væksthormoner, var blevet udelukket.
English: NutropinAq is used until the child receives a kidney transplant.
Danish: NutropinAq anvendes, indtil barnet får en nyretransplantation.
English: On 24 January 2008, Ipsen Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for NutropinAq, for the long-term treatment of children with severe idiopathic short stature.
Danish: Den 24. januar 2008 meddelte Ipsen Ltd officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønskede at tilbagetrække sin ansøgning om en ny indikation for NutropinAq til langtidsbehandling af børn med svær idiopatisk lav højdevækst.
English: What is happening for NutropinAq for treatment of failure to grow due to growth hormone deficiency, Turner syndrome or chronic renal insufficiency?
Danish: Hvad sker der med NutropinAq til behandling af manglende evne til at vokse på grund af væksthormonmangel, Turners syndrom eller kronisk nyreinsufficiens?
English: For the first year, the study compared the effectiveness of NutropinAq given three times a week with that of no treatment.
Danish: I det første år af undersøgelsen blev virkningen af NutropinAq givet tre gange ugentligt sammenlignet med virkningen af ingen behandling.
English: The CHMP was concerned that only a modest benefit of NutropinAq in severe idiopathic short stature had been demonstrated, with an average gain in final adult height of around 6 to 7 cm in the main study.
Danish: CHMP var betænkelig ved, at der kun var påvist en lille fordel ved NutropinAq hos børn med svær idiopatisk lav højdevækst med en gennemsnitlig stigning i den endelige voksenhøjde på ca. 6-7 cm i hovedundersøgelsen.
English: It is given by injection under the skin, using the injection pen specially designed for the cartridge.
Danish: Det gives som en injektion under huden ved hjælp af en injektionspen, der er specielt designet til cylinderampullen.
English: It was to be used as long-term treatment in children who were predicted to be short, in comparison with their parents' height, once they had reached adulthood.
Danish: Det skulle have været anvendt til langtidsbehandling af børn, der forventedes at have en lav sluthøjde sammenlignet med deres forældres højde, når de nåede voksenalderen.
English: The company presented the results of one main study looking at the effectiveness of NutropinAq in 118 children with short stature who did not have growth hormone deficiency or any other identifiable condition that could cause their growth impairment.
Danish: Virksomheden fremlagde resultater fra én hovedundersøgelse, hvori forskerne så nærmere på virkningen af NutropinAq hos 118 børn med lav højde, der ikke led af væksthormonmangel eller anden identificerbar sygdom, der kunne være årsag til deres vækstforstyrrelse.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using NutropinAq?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med NutropinAq eller i programmer for anvendelse af NutropinAq med særlig udleveringstilladelse?
English: Based on the review of the data and the company's response to the CHMP's list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend the approval of NutropinAq for the long-term treatment of children with severe idiopathic short stature.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP afgivet en negativ udtalelse og anbefalede ikke udstedelse af markedsføringstilladelse for NutropinAq til langtidsbehandling af børn med svær idiopatisk lav højdevækst.
English: The Committee raised a concern that the use of NutropinAq for the long periods necessary to treat severe idiopathic short stature might increase the risk of the development of tumours or diabetes later in life.
Danish: Udvalget var betænkelig ved, at anvendelsen af NutropinAq i så lang tid, som det var nødvendigt for at behandle den svære idiopatiske lave højdevækst, kunne øge risikoen for udvikling af tumorer eller diabetes senere i livet.
English: NutropinAq is a solution for injection in a cartridge, which contains the active substance somatropin.
Danish: NutropinAq er en opløsning til injektion, der leveres i en cylinderampul, og som indeholder det aktive stof somatropin.
English: Therefore, at the time of the withdrawal, the CHMP's view was that that the benefits of NutropinAq in the long-term treatment of children with severe idiopathic short stature did not outweigh its possible risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved NutropinAq til langtidsbehandling af svær idiopatisk lav højdevækst ikke opvejede de mulige risici.
English: • before puberty, when they fail to grow because of longstanding kidney disease (chronic renal insufficiency).
Danish: • når de i førpubertetsalderen ikke vokser på grund af langvarig nyresygdom (kronisk nyreinsufficiens).
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes in Europe with NutropinAq in this indication.
Danish: Virksomheden har informeret CHMP om, at der på nuværende tidspunkt ikke gennemføres kliniske undersøgelser med NutropinAq eller programmer for anvendelse af NutropinAq med særlig udleveringstilladelse, der omfatter denne indikation, i Europa.
English: difference between the height that each child was predicted to reach based on their height and bone maturity before they started to receive NutropinAq, and their actual height when they had reached adulthood.
Danish: Målingen blev baseret på forskellen mellem den højde, børnene blev beregnet til at opnå på baggrund af deres højde og knoglemodenhed, før de påbegyndte behandlingen med NutropinAq, og deres sluthøjde, når de nåede voksenalderen.
English: NutropinAq is also used to treat adults with growth hormone deficiency, as replacement therapy.
Danish: NutropinAq anvendes også som substitutionsbehandling ved væksthormonmangel hos voksne.
English: In the new indication, NutropinAq was expected to be used to treat children with ‘severe idiopathic short stature' (severe growth impairment with no identifiable cause).
Danish: NutropinAq skulle i den nye indikation have været anvendt til behandling af børn med svær idiopatisk lav højdevækst, dvs. en alvorlig forstyrrelse af højdevæksten uden identificeret årsag.
English: After this, the design of the study was changed so that the patients received NutropinAq given either three times a week or once a day.
Danish: Derefter blev undersøgelsesdesignet ændret, så patienterne fik NutropinAq enten
English: Growth hormone is a substance secreted by a gland located at the base of the brain called the pituitary gland.
Danish: Et væksthormon er et stof, der udskilles af en kirtel, der befinder sig i bunden af hjernen, nemlig hypofysen.
English: ATC code: A16AB15.
Danish: ATC-kode: A16AB15.
English: Patients n=33
Danish: Patienter N = 33
English: This may improve the symptoms of the disease.
Danish: Dette kan forbedre symptomerne på sygdommen.
English: (1) MCID: minimal clinically important difference
Danish: (1) MCID: minimal klinisk vigtig forskel (minimal clinically important difference)
English: Annual reports to be submitted as part of the annual reassessment
Danish: Årlige rapporter skal indsendes som en del af den årlige genvurdering.
English: Lamzede Last Observation
Danish: Lamzede Sidste observation
English: White to off-white powder.
Danish: Hvidt til off-white pulver.
English: Example:
Danish: Eksempel:
English: Only the volume corresponding to the recommended dose should be administered.
Danish: Kun det volumen, der svarer til den anbefalede dosis, må administreres.
English: Date of first authorisation: 23/03/2018
Danish: Dato for første markedsføringstilladelse: 23/03/2018
English: The reconstituted vials should stand on the table for about 5-10 minutes.
Danish: De rekonstituerede hætteglas skal stå på bordet i ca. 5-10 minutter.
English: Lamzede 12 months
Danish: Lamzede 12 måneder
English: Linearity/(Non)linearity
Danish: Linearitet/non-linearitet
English: The infusion time can be calculated from the following table:
Danish: Infusionstiden kan beregnes ud fra den følgende tabel:
English: There is a potential for immunogenicity.
Danish: Der er mulighed for immunogenicitet.
English: While under treatment with Lamzede, you may experience some of the following reactions:
Danish: Mens du er i behandling med Lamzede, kan du opleve nogle af de følgende reaktioner:
English: This is known as an infusion-related reaction and can sometimes be severe.
Danish: Dette kaldes en infusionsrelateret reaktion, og sådan en reaktion kan til tider være svær.
English: Lamzede may be given to children and adolescents at the same dose and frequency as in adults.
Danish: Lamzede kan gives til børn og unge med den samme dosis og med samme hyppighed som hos voksne.
English: No treatment was administered.
Danish: Der blev ikke givet nogen behandling.
English: In the most severe cases, the current medical standards for emergency treatment are to be observed.
Danish: I de sværeste tilfælde skal de gældende medicinske standarder for nødbehandling følges.
English: - Most of the time you can still be given Lamzede even if you experience an infusion-related reaction.
Danish: - Du kan i de fleste tilfælde stadig få Lamzede, selv hvis du oplever en infusionsrelateret reaktion.
English: a) The number of vials to be used should be calculated based on the individual patient's weight.
Danish: a) Det antal hætteglas, der skal bruges, skal beregnes ud fra den individuelle patients vægt.
English: It is given for the treatment of non-neurological symptoms of the disease.
Danish: Det gives til behandling af de ikke-neurologiske symptomer på sygdommen.
English: See sections 4.4 and 5.1.
Danish: 4.4 og 5.1.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Danish: Dette er en godkendelse under særlige vilkår, og i henhold til artikel 14, stk. 8, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: Patient weight (kg)
Danish: Patientvægt (kg)
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before this medicine is used.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før dette lægemiddel bruges.
English: Patients with the most severe rapidly progressing phenotype (with a deterioration within one year and central nervous system involvement) were excluded.
Danish: Patienter med den sværeste fænotype med hurtig progression (med en forværring inden for et år og involvering af centralnervesystemet) blev ekskluderet.
English: The results observed in patients below 18 years of age showed an improvement.
Danish: De observerede resultater hos patienter under 18 år viste en forbedring.
English: Patients were diagnosed based on alpha-mannosidase activity <10% of normal activity in blood leukocytes.
Danish: Patienter blev diagnosticeret baseret på alfa-mannosidase-aktivitet <10 % af normal aktivitet i leukocytterne i blodet.
English: Lamzede should be used during pregnancy only when medically necessary.
Danish: Lamzede bør kun anvendes under graviditeten, når det er medicinsk nødvendigt.
English: The effects of velmanase alfa were more evident in patients younger than 18 years.
Danish: Virkningen af velmanase alfa var mere evident hos patienter under 18 år.
English: Approximately 30 minutes prior to reconstitution, the required number of vials should be removed from the refrigerator.
Danish: Ca. 30 minutter før rekonstitution skal det nødvendige antal hætteglas fjernes fra køleskabet.
English: All were mild or moderate in severity and none were reported as a serious adverse event.
Danish: De var alle lette eller moderate i sværhedsgrad, og ingen blev rapporteret som alvorlige bivirkninger.