FrancophonIA/ELRC3.0 huggingface dataset:
English: Instructions on the administration of glucagon should severe hypoglycaemia occur.
Danish: Vejledning i indgivelse af glukagon, hvis der skulle opstå alvorlig hypoglykæmi.
English: The symptoms in the cases indicative of anaphylaxis included hives, angioedema and dyspnoea.
Danish: Symptomerne i de tilfælde, som tydede på anfylaksi inkluderede udslæt, angioødem og dyspnø.
English: The typical dose is 0.04 to 0.12 mg/kg of patient weight administered twice a day.
Danish: Den sædvanlige dosis er 0,04 til 0,12 mg/kg legemsvægt to gange daglig.
English: Circulating IGF-1 plays an important role in the acquisition and maintenance of bone mass. IGF-1 increases bone density.
Danish: Cirkulerende IGF-1 spiller en vigtig rolle i dannelse og opretholdelse af knoglemasse.
English: In post-marketing experience in patients treated with INCRELEX, cases of hypersensitivity, urticaria, pruritus and erythema have been reported.
Danish: Efter markedsføring er der rapporteret tilfælde af hypersensitivitet, urticaria, pruritus og erytem hos patienter behandlet med INCRELEX.
English: Uncommon: Increased weight
Danish: Ikke almindelig: Vægtøgning
English: Efficacy is dose dependent.
Danish: Effekten er dosisafhængig.
English: Stop INCRELEX immediately and seek urgent medical advice if you develop seizures/fits or become unconscious.
Danish: Du skal straks søge læge og stoppe med at tage INCRELEX, hvis du får kramper/anfald eller bliver bevidstløs.
English: Skin and hair changes Skin thickening, moles and abnormal hair texture have been seen with mecasermin treatment.
Danish: Fortykkelse af huden, modermærker og abnorm hårtekstur er blevet set ved behandling med mercasermin.
English: Ipsen Portugal - Produtos Farmacêuticos S.A. Alameda Fernão Lopes, no 16-11o, Miraflores P-1495 - 190 Algés
Danish: Ipsen Portugal - Produtos Farmacêuticos S.A. Alameda Fernão Lopes, n o o, Miraflores
English: Common (may affect up to 1 in 10 people) Seizures
Danish: Almindelige (forekommer hos op til 1 ud af 10 patienter) Kramper
English: Generalised hives, difficulty in breathing, dizziness, swelling of the face and/or throat have been reported following mecasermin use.
Danish: Der har været rapporteret tilfælde af alment udslæt, besvær med at trække vejret, svimmelhed, hævelse i ansigt og/eller svælg efter brug af mercasermin.
English: Rue d'Ethe Virton
Danish: Beaufour Ipsen Industrie Rue d'Ethe Virton
English: Common: Injection site pain, injection site reaction, injection site haematoma, injection site erythema, injection site induration, injection site haemorrhage, injection site irritation
Danish: Meget almindelig: Hypertrofi ved injektionsstedet, blå mærker ved injektionsstedet Almindelig: Smerter på injektionsstedet, reaktioner på injektionsstedet, hæmatom på injektionsstedet, erytem på injektionsstedet, induration på injektionsstedet, blødning på injektionsstedet, irritation på injektionsstedet Ikke almindelig: Udslæt på injektionsstedet, hævelse på injektionsstedet, lipohypertrofi
English: Clinical Trial
Danish: Klinisk forsøg
English: INCRELEX may have a major influence on the ability to drive or use machines in case of a hypoglycaemic episode.
Danish: I tilfælde af hypoglykæmi kan INCRELEX i væsentlig grad påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: Injection site hypertrophy (tissue at injection site increases in size) and bruising These can be avoided by changing the injection site at each injection (injection site rotation).
Danish: Forstørrelse af vævet (hypertrofi) og blå mærker ved injektionsstedet Dette kan undgås ved at ændre injektionssted ved hver indsprøjtning (rotation af injektionssted).
English: EXP After first opening, use within 30 days.
Danish: Udløbsdato Skal anvendes senest 30 dage efter åbning.
English: Severe hypoglycaemia may cause unconsciousness, seizures/fits or death.
Danish: Meget lavt blodsukker kan medføre bevidstløshed, kramper/anfald eller død.
English: - if you develop a limp or hip or knee pain - if you have enlarged tonsils (tonsillar hypertrophy).
Danish: - Hvis du har forstørrede mandler (hypertrophia tonsillarum).
English: Enlarged thymus
Danish: Forstørret thymus (brissel)
English: The symptoms of intracranial hypertension can include visual changes, headache, nausea and/or vomiting.
Danish: Symptomerne på forhøjet tryk i hjernen kan omfatte synsforstyrrelser, hovedpine, kvalme og/eller opkastning.
English: Very common: Hypoglycaemia Common: Hypoglycaemic seizure, hyperglycaemia
Danish: Almindelig: Hypoglykæmiske kramper, hyperglykæmi
English: Postmarketing reports of local allergic reactions were also received.
Danish: Der var også tilfælde af lokale allergiske reaktioner efter markedsføringen.
English: Injection site reactions can be avoided by changing the injection site at each injection (injection site rotation).
Danish: Reaktioner ved injektionsstedet kan undgås ved at ændre injektionssted ved hver indsprøjtning (rotation af injektionssted).
English: Local allergic reactions at the injection site (itching, hives) have also been reported.
Danish: Der har også været tilfælde af lokale allergiske reaktioner ved injektionsstedet (kløe og udslæt).
English: - if you have symptoms of increased pressure in the brain (intracranial hypertension), such as visual changes, headache, nausea and/or vomiting, contact the doctor for advice.
Danish: - Hvis du har symptomer på forøget tryk i hjernen (intrakranial hypertension), såsom synsforstyrrelser, hovedpine, kvalme og/eller opkastninger.
English: Reactions including pain, irritation, bleeding, bruising, redness and hardening have been reported with INCRELEX treatment.
Danish: Der er rapporteret reaktioner såsom smerter, irritation, blødning, blå mærker, rødme og hårde områder under behandling med INCRELEX.
English: An increased incidence of mammary gland carcinoma in both male and female rats was observed in animals treated with 10 mg/kg/day (7 times the exposure with the MRHD based on AUC).
Danish: En øget forekomst af mælkekirtelkarcinom hos både han- og hunrotter blev observeret hos dyr, der blev behandlet med 10 mg/kg/dag (7 gange eksponeringen med MRHD, baseret på AUC).
English: An increased incidence of keratoacanthoma in the skin was observed in male rats at doses of 4 and 10 mg/kg/day ( 4 times the exposure with the MRHD based on AUC).
Danish: En øget forekomst af keratoacanthom i huden blev observeret hos hanrotter ved doser på 4 og 10 mg/kg/dag ( 4 gange eksponeringen med MRHD, baseret på AUC).
English: If a vial freezes, dispose appropriately.
Danish: Hvis et hætteglas har været frosset, skal det kasseres.
English: A negative pregnancy test is recommended for all women of child bearing potential prior to treatment with mecasermin.
Danish: Det anbefales, at der foreligger en negativ graviditetstest for alle kvinder i den fødedygtige alder forud for behandling med mercasermin.
English: Your doctor can check to see if intracranial hypertension is present.
Danish: Lægen kan kontrollere, om der er et forhøjet tryk i hjernen.
English: You should be monitored for progression of scoliosis.
Danish: Udviklingen af sygdommen skoliose skal overvåges.
English: Common: Cardiac murmur, tachycardia
Danish: Almindelig: Hjertemislyd, takykardi
English: One ml contains 10 mg of mecasermin.
Danish: En ml indeholder 10 mg mecasermin.
English: Do not use INCRELEX - if you are allergic to mecasermin or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis du er allergisk over for mecasermin eller et af de øvrige indholdsstoffer i INCRELEX
English: Echocardiogram is recommended before initiation of mecasermin treatment in all patients.
Danish: Det anbefales, at alle patienter får taget et ekkokardiogram inden behandlingen med mecasermin påbegyndes.
English: Nervous system Headache has occurred with mecasermin treatment.
Danish: Nervesystemet Hovedpine er forekommet under behandling med mercasermin.
English: • To avoid engaging in any high-risk activities (such as vigorous physical activity) within 2 - 3 hours after dosing, particularly at the initiation of INCRELEX treatment, until a well-tolerated dose of INCRELEX has been established.
Danish: • Patienten skal undgå høj-risiko-aktiviteter (såsom voldsom fysisk aktivitet) i 2-3 timer efter doseringen, indtil en veltolereret dosis af INCRELEX er fastlagt.
English: Reactions including rash, swelling and fatty lumps have been reported with INCRELEX treatment.
Danish: Der har været tilfælde af reaktioner såsom udslæt, hævelse og fedtholdige buler ved behandling med INCRELEX.
English: Dizziness and tremor have also been reported with mecasermin treatment.
Danish: Svimmelhed og rysten er også rapporteret under behandling med mercasermin.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Danish: Disse bivirkninger er ikke observeret i kliniske studier, men er formentligt klinisk relevante:
English: Digestive system Vomiting and pain in the upper belly have occurred with mecasermin treatment.
Danish: Fordøjelsessystemet Opkastning og smerter i den øvre del af maven er opstået under behandling med mercasermin.
English: One multi-use vial of 4 ml.
Danish: Et hætteglas med 4 ml til flergangsbrug.
English: 140 00 Praha 4 Tel: + 420 242 481 821
Danish: Evropská 136/810 CZ-160 00 Praha 6 Tel: + 420 242 481 821
English: Pull the needle straight out and gently press on the spot where you injected you with gauze or a cotton ball for a few seconds.
Danish: Træk kanylen lige ud, og tryk forsigtigt et par sekunder på det sted, hvor du sprøjtede dig selv, med gaze eller en tot vat. Du må ikke gnide på stedet (se figur B).
English: Musculoskeletal and connective Very common: Arthralgia, pain in tissue disorders extremity Common: Scoliosis, myalgia
Danish: Meget almindelig: Artralgi, ekstremitetssmerter Almindelig: Skoliose, myalgi
English: If the solution is cloudy, or contains particulate matter, it must not be injected.
Danish: Opløsningen må ikke injiceres, hvis den er uklar eller indeholder partikler.
English: In target tissues the Type 1 IGF-1 receptor, which is homologous to the insulin receptor, is activated by IGF-1, leading to intracellular signaling which stimulates multiple processes leading to statural growth.
Danish: I målvæv aktiveres type 1 IGF-1-receptoren, som er homolog til insulinreceptoren, af IGF-1.
English: In adolescents with Primary IGFD and in healthy adults there were no apparent differences between males and females in the pharmacokinetics of INCRELEX.
Danish: De farmakokinetiske egenskaber ved INCRELEX viste ingen tydelig forskel mellem han- og hunkøn hos unge med primær IGFD og raske voksne.
English: Tel. + 370 37 337854
Danish: LT-48100 Kaunas Tel. + 370 37 337854
English: Glacial acetic acid Sodium acetate Water for injections
Danish: Koncentreret eddikesyre Natriumacetat Vand til injektionsvæsker.
English: Uncommon: Cardiomegaly, ventricular hypertrophy, mitral valve incompetence, tricuspid valve incompetence
Danish: Ikke almindelig: Kardiomegali, ventrikulær hypertrofi, mitralklapinsufficiens, trikuspidalklapinsufficiens
English: If more INCRELEX than recommended was injected, contact your doctor immediately.
Danish: Kontakt straks lægen, hvis du har indsprøjtet mere INCRELEX end anbefalet.
English: When injections were properly dispersed, the condition resolved.
Danish: Tilstanden forsvandt, når injektionerne blev spredt ud.
English: Sleep apnea can cause excessive daytime sleepiness.
Danish: Søvnapnø kan medføre, at du bliver meget søvnig i løbet af dagen.
English: INCRELEX 10 mg/ml solution for injection Mecasermin
Danish: INCRELEX 10 mg/ml injektion mecasermin s.c.
English: The vial contains 4 ml of solution.
Danish: Hætteglasset indeholder 4 ml opløsning.
English: Treatment of acute overdose of mecasermin should be directed at reversing hypoglycaemia.
Danish: Behandlingen af en akut overdosering af mecasermin skal fokusere på at afhjælpe lavt blodsukker (hypoglykæmi).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Bivirkningerne præsenteres efter frekvens med angivelse af de alvorligste bivirkninger først indenfor hver frekvensgruppe.
English: Intracranial hypertension/increased intracranial pressure This occurred in 4 subjects (0.96%); in two subjects INCRELEX was discontinued and not restarted; in two subjects the event did not recur after restarting INCRELEX at a reduced dose.
Danish: Hos to patienter blev INCRELEX seponeret og ikke genstartet, hos to patienter forekom tilstanden ikke igen efter genstart af INCRELEX ved nedsat dosis.
English: Heart abnormalities A fast heart rate and abnormal heart sounds have been reported with mecasermin treatment.
Danish: Der er rapporteret en hurtig hjerterytme (puls) og unormale hjertelyde under behandling med mercasermin.
English: Cardiac disorders
Danish: Afvigelser i hjertefunktionen
English: Very common: Otitis media Common: Hypoacusis, ear pain, middle ear effusion
Danish: Meget almindelig: Otitis media Almindelig: Hypakusi,
English: Each ml contains 10 mg of mecasermin*.
Danish: 1 ml indeholder 10 mg mecasermin*.
English: Figure 3: Prepare for extraction
Danish: Figur 3: Gør klar til at trække væske op
English: From a microbiological point of view, once opened, the medicinal product may be stored for a maximum of 30 days at 2C to 8C.
Danish: Fra et mikrobiologisk synspunkt kan lægemidlet opbevares i maks.
English: SC
Danish: SN:
English: • GH sufficiency.
Danish: • væksthormon (GH)-sufficiens
English: Do not make up the missed dose by giving two doses the next time.
Danish: Du må ikke tage en dobbeltdosis næste gang som erstatning for den glemte dosis.
English: How to store INCRELEX
Danish: Sådan skal du tage INCRELEX
English: Hypoacusis (hearing loss), ear pain and fluid in the middle ear have been observed with mecasermin treatment.
Danish: Høretab, øresmerter og væske i mellemøret er observeret under behandling med mercasermin.
English: Reactions observed from the post-marketing environment
Danish: Bivirkninger rapporteret efter markedsføringen
English: Tel: + 351 - 21 - 412 3550
Danish: P-1495 - 190 Algés Tel: + 351 - 21 - 412 3550
English: Reproductive system Breast enlargement has been observed with mecasermin treatment.
Danish: Forplantningssystemet Der er blevet observeret forstørrelse af brysterne under behandling med mercasermin.
English: 6.6 Special precautions for disposal and other handling INCRELEX is supplied as a multi-dose solution.
Danish: INCRELEX leveres som en opløsning til flergangsbrug.
English: Posology
Danish: Høretab
English: Brodišče 32 SI-1236 Trzin Tel: + 386 1 236 47 00
Danish: Pharmaswiss d.o.o Dolenjska cesta 242c SI-1000 Ljubljana Tel: + 386 1 236 47 00
English: Hold the syringe and vial firmly (see Figure
Danish: Hold godt fast i sprøjten og hætteglasset (se figur 3).
English: Musculoskeletal system Joint pains and pains in the limbs have occurred with mecasermin treatment.
Danish: Musker og knogler Smerter i led og lemmer er opstået under behandling med mercasermin.
English: Papilloedema
Danish: Papilødem
English: Very common: Headache Common: Convulsions, dizziness, tremor
Danish: Meget almindelig: Hovedpine Almindelig: Kramper, svimmelhed, tremor Ikke almindelig: Benign intrakraniel hypertension
English: If you have scoliosis, you will need to be checked often for an increase in the curve of the spine.
Danish: Forværret rygskævhed (skoliose) (på grund af hurtig vækst) Hvis du har en skæv ryg, skal det kontrolleres jævnligt, om din rygsøjle bliver mere krum.
English: You should avoid engaging in any high-risk activities (e.g., driving, etc.) within 2-3 hours after dosing, particularly at the start of INCRELEX treatment, until a dose of INCRELEX has been found which does not cause side effects that make these activities risky.
Danish: Dette gælder især i begyndelsen af INCRELEX-behandlingen og indtil der er fastlagt en INCRELEX-dosis, hvor der ikke forekommer bivirkninger, som gør disse aktiviteter risikable.
English: One ml contains 9 mg of benzyl alcohol.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: 1 ml indeholder 9 mg benzylalkohol.
English: Weight increase Weight increase has been observed with mecasermin treatment.
Danish: Vægtøgning Der er observeret vægtøgning under behandling med mercasermin.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic Safety Update Reports
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Each vial contains 4 ml of solution.
Danish: Hvert hætteglas indeholder 4 ml injektionsvæske.
English: Injection site hypertrophy
Danish: Hypertrofi på injektionsstedet
English: Each vial of 4 ml contains 40 mg of mecasermin*.
Danish: 1 hætteglas indeholder 40 mg mecasermin*.
English: Each vial contains 40 mg of mecasermin.
Danish: Et hætteglas indeholder 40 mg mecasermin.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40mg/4ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: If you use more INCRELEX than you should
Danish: Hvis du har taget for meget INCRELEX
English: After first use, the vial may be stored for up to 30 days at 2C to 8ºC.
Danish: 30 dage ved 2C til 8C efter åbning.
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret INCRELEX til dig personligt.
English: Injection sites should be rotated to a different site with each injection.
Danish: Der skal skiftes injektionssted ved hver injektion.
English: NAME OF THE MEDICINAL PRODUCT INCRELEX 10 mg/ml solution for injection mecasermin
Danish: INCRELEX 10 mg/ml injektionsvæske Mecasermin
English: The injection site should be changed for each injection (rotate the injection site).
Danish: Du skal skifte indgivelsessted, hver gang du indsprøjter (rotér indgivelsesstedet).
English: Enlarged tonsils/adenoids
Danish: Forstørrede mandler/polypper
English: Digestive system Pain in the belly has occurred with mecasermin treatment.
Danish: Fordøjelsessystemet Der er forekommet mavesmerter under behandling med mercasermin.
English: Sugarcontaining fluids or food should be consumed.
Danish: Du/dit barn bør indtage væske eller føde, der indeholder sukker.
English: NAME OF THE MEDICINAL PRODUCT INCRELEX 10 mg/ml solution for injection
Danish: INCRELEX 10 mg/ml injektionsvæske, opløsning
English: It may harm them, even if their signs of illness are the same as yours.
Danish: Bestem, hvor du vil indsprøjte - overarm, lår, baller eller bugen (se nedenfor).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rilutek on 10 June 1996.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rilutek den 10. juni 1996.
English: Rilutek riluzole
Danish: Rilutek riluzol
English: The full EPAR for Rilutek can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Rilutek findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Rilutek.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rilutek.
English: One of these studies was in older patients (over 75) and in patients with advanced disease.
Danish: Den ene undersøgelse omfattede ældre patienter (over 75 år) og patienter med fremskreden sygdom.
English: It is available as 50 mg tablets.
Danish: Det leveres som 50 mg-tabletter.
English: Other information about Rilutek
Danish: Andre oplysninger om Rilutek
English: Rilutek has been compared with placebo (a dummy treatment) in three studies involving a total of 1,282 patients.
Danish: Rilutek blev sammenlignet med placebo (en virkningsløs behandling) i tre undersøgelser med tilsammen 1 282 patienter.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rilutek.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Rilutek skal anvendes.
English: For more information about treatment with Rilutek, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Rilutek, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Riluzole stops the release of glutamate and this may help in preventing the nerve cells being damaged.
Danish: Riluzol standser frigivelsen af glutamat, og dette kan medvirke til at forhindre skade på nervecellerne.
English: Rilutek must also not be given to women who are pregnant or breastfeeding.
Danish: Rilutek må heller ikke gives til gravide eller ammende.
English: EMEA/H/C/000109
Danish: EMA/234576/2016 EMEA/H/C/000109
English: The main measure of effectiveness was the average survival time.
Danish: Behandlingens virkning blev hovedsagelig bedømt på den gennemsnitlige overlevelsestid.
English: The most common side effects seen with Rilutek (in more than 1 patient in 10) are nausea (feeling sick), asthenia (weakness) and abnormal liver tests.
Danish: De hyppigste bivirkninger af Rilutek (som ses hos flere end 1 ud af 10 patienter) er kvalme, kraftesløshed og abnorme leverprøver.
English: Rilutek 50 mg/day was no more effective than placebo and 200 mg/day was no more effective than 100 mg/day.
Danish: 50 mg Rilutek dagligt var ikke mere effektivt end placebo, og 200 mg dagligt var ikke mere effektivt end 100 mg dagligt.
English: The recommended dose is 100 mg per day (given as one 50 mg tablet every 12 hours).
Danish: Den anbefalede dosis er 100 mg dagligt (50 mg hver 12. time).
English: It is thought that the destruction of nerve cells in motor neuron disease may be caused by too much of the neurotransmitter glutamate.
Danish: Det menes, at ødelæggelsen af nervecellerne ved sygdommen kan skyldes en for høj forekomst af neurotransmitteren glutamat.
English: The exact way in which it works in ALS is not known.
Danish: Det vides ikke nøjagtigt, hvordan lægemidlet virker ved ALS.
English: Rilutek is a medicine containing the active substance riluzole.
Danish: Rilutek er et lægemiddel, der indeholder det aktive stof riluzol.
English: Rilutek is used in patients with amyotrophic lateral sclerosis (ALS).
Danish: Rilutek anvendes til behandling af amyotrofisk lateral sklerose (ALS).
English: What is the risk associated with Rilutek?
Danish: Hvilken risiko er der forbundet med Rilutek?
English: The CHMP decided that Rilutek's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Rilutek opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Rilutek.
English: Across the studies, Rilutek was given as 50, 100 or 200 mg per day, and for up to 18 months.
Danish: I undersøgelserne blev Rilutek givet i en dosering på 50, 100 eller 200 mg dagligt i op til 18 måneder.
English: Treatment with Rilutek should only be started by a specialist doctor with experience in the management of motor neuron diseases.
Danish: Behandling med Rilutek bør kun iværksættes af en speciallæge med erfaring i behandling af sygdomme i motorneuronerne.
English: The active substance in Rilutek, riluzole, acts on the nervous system.
Danish: Det aktive stof i Rilutek, riluzol, virker på nervesystemet.
English: The average survival time was significantly longer for patients who received Rilutek compared with patients who received placebo.
Danish: Den gennemsnitlige overlevelsestid for de patienter, der fik Rilutek, var signifikant længere end for dem, der fik placebo.