FrancophonIA/ELRC3.0 huggingface dataset:
English: • That patients should have examinations of the ears, nose and throat periodically and at the occurrence of clinical symptoms to rule out such potential complications or to initiate appropriate treatment.
Danish: • Patienterne skal have undersøgt, ører næse og hals undersøgt med regelmæssige mellemrum og ved forekomst af kliniske symptomer for at udelukke sådanne potentielle komplikationer eller for at iværksætte en passende behandling.
English: Signs of low blood sugar are: dizziness, tiredness, restlessness, hunger, irritability, trouble concentrating, sweating, nausea and fast or irregular heartbeats.
Danish: Følgende er tegn på lavt blodsukker: svimmelhed, træthed, rastløshed, sult, irritabilitet, manglende koncentrationsevne, sveden, kvalme og hurtig eller uregelmæssig hjerterytme.
English: These have been observed both as being systemic and/or local to the injection site.
Danish: Der er observeret systemiske reaktioner og/eller lokale reaktioner ved injektionstedet.
English: MARKETING AUTHORISATION HOLDER Ipsen Pharma
Danish: Indehaver af markedsføringstilladelsen: Ipsen Pharma
English: Preparing the dose
Danish: Klargøring af dosis
English: Tonsillar hypertrophy
Danish: Tonsillær hypertrofi
English: Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og etiketten efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Slipped capital femoral epiphysis (with the potential to lead to avascular necrosis) and progression of scoliosis can occur in patients who experience rapid growth.
Danish: Forskudt caput femoralis epifyser (med risiko for at medføre avaskulær nekrose) og udvikling af skoliose kan forekomme hos patienter i hurtig vækst.
English: Before putting the needle into the vial, pull back on plunger to draw air into the syringe equal to the prescribed dose.
Danish: Inden du stikker kanylen i hætteglasset, skal du trække stemplet tilbage for at trække den mængde luft ind i sprøjten, som svarer til den ordinerede dosis.
English: • To educate parents on the signs, symptoms and treatment of hypoglycaemia, including injection of glucagon.
Danish: • Forældrene skal oplyses om tegn, symptomer og behandling af hypoglykæmi, herunder injektion af glukagon.
English: Acute overdose could lead to hypoglycaemia.
Danish: En akut overdosering kan føre til hypoglykæmi.
English: INFORMATION IN BRAILLE INCRELEX
Danish: INFORMATION I BRAILLESKRIFT
English: If you stop using INCRELEX
Danish: Hvis du holder op med at tage INCRELEX
English: • To report any onset of a limp or complaint of hip or knee pain to their physician so it can be evaluated.
Danish: • Rapportering af halthed eller smerter i hofte eller knæ til lægen, så dette kan evalueres.
English: Biotransformation Both the liver and the kidney have been shown to metabolise IGF-1.
Danish: Biotransformation Det er påvist, at både lever og nyrer metaboliserer IGF-1.
English: Studies have not been conducted with mecasermin in breast-feeding mothers.
Danish: Der er ikke gennemført studier med mecasermin hos ammende mødre.
English: Persons with a history of severe hypoglycemia should have glucagon available.
Danish: Personer med en anamnese for svær hypoglykæmi bør have glukagon inden for rækkevidde.
English: 40mg/4ml
Danish: 4 ml
English: No subject discontinued the studies due to adverse events.
Danish: Ingen forsøgspersoner udgik af studierne på grund af bivirkninger.
English: Your doctor or nurse will instruct you how to give the injection of glucagon.
Danish: Lægen eller sygeplejersken vil vise dig, hvordan du skal indsprøjte glukagon.
English: Inject INCRELEX just below the skin in your upper arm, upper leg (thigh), stomach area (abdomen), or buttocks.
Danish: Indsprøjt INCRELEX lige under huden på din overarm, lår, maveområde (bugen) eller balle.
English: Make sure the tip of the needle is in the liquid (see Figure 4).
Danish: Sørg for, at kanylespidsen er nede i væsken (se figur 4).
English: How to use INCRELEX 4.
Danish: Sådan skal du tage INCRELEX 4.
English: The height velocities at a given year of treatment were compared by paired t-tests to the pre-treatment height velocities of the same subjects completing that treatment year.
Danish: Væksthastigheden for et givent år blev sammenlignet med væksthastigheden for de samme patienter, som afsluttede behandlingen det pågældende år, ved hjælp af parvise t-tests.
English: Common: Skin hypertrophy, abnormal hair texture
Danish: Almindelig: Hypertrofi i huden, unormal hårtekstur
English: Wipe the rubber stopper of the vial with an alcohol swab to prevent contamination of the vial by germs that may be introduced by repeated needle insertions (see Figure 1).
Danish: Tør gummiproppen på hætteglasset af med en spritserviet for at forhindre, at glasset forurenes med bakterier, som kan stamme fra flere kanyleindføringer (se figur 1).
English: Children The pharmacokinetics of INCRELEX have not been studied in subjects younger than 12 years of age.
Danish: Børn De farmakokinetiske egenskaber ved INCRELEX er ikke undersøgt hos patienter under 12 år.
English: If you forget to use INCRELEX
Danish: Hvis du har glemt at tage INCRELEX
English: The most frequently occurring side effects with mecasermin are: low blood sugar (hypoglycemia), vomiting, injection site reactions, headache and middle ear infections.
Danish: De hyppigst forekommende bivirkninger ved mercasermin er: Lavt blodsukker (hypoglykæmi), opkastning, reaktioner ved injektionsstedet, hovedpine og mellemørebetændelse.
English: Do not recap the syringe.
Danish: Sæt ikke hætten tilbage på sprøjten.
English: Increased pressure in the brain (intracranial hypertension) INCRELEX can sometimes cause a temporary increase in pressure within the brain.
Danish: INCRELEX kan nogle gange medføre et midlertidigt forhøjet tryk i hjernen.
English: Renal impairment No studies have been conducted in children with renal impairment.
Danish: Nedsat nyrefunktion Der er ikke gennemført studier af børn med nedsat nyrefunktion.
English: • Possible occurrence of malignancies as well as other risks The interim reports will be submitted every two years until the final patient is followed for 5 years.
Danish: De foreløbige rapporter skal indsendes hvert 2. år, indtil den sidste patient har været fulgt i 5 år.
English: Symptomatic hypoglycaemia was generally avoided when a meal or snack was consumed either shortly before or after the administration of INCRELEX.
Danish: Generelt blev symptomatisk hypoglykæmi undgået, hvis patienten indtog et måltid eller et mellemmåltid enten umiddelbart inden eller efter indgivelse af INCRELEX.
English: The mean terminal t1/2 of total IGF-1 after single subcutaneous administration of 0.12 mg/kg in three paediatric subjects with severe Primary IGFD is estimated to be 5.8 hours.
Danish: Den gennemsnitlige terminale halveringstid (t1/2) af total IGF-1 efter en enkelt subkutan indgivelse af 0,12 mg/kg hos tre pædiatriske patienter med svær primær IGFD anslås til at være 5,8 timer.
English: There were also reports of systemic hypersensitivity from post-marketing use, of which some cases were indicative of anaphylaxis.
Danish: Ved brug efter markedsføringen var der også tilfælde af systemisk hypersensitivitet, hvoraf nogle tilfælde tydede på anafylaksi.
English: The doctor should regularly examine your tonsils/adenoids.
Danish: Lægen skal undersøge dine mandler/polypper med regelmæssige mellemrum.
English: Common: Sleep apnoea syndrome, adenoidal hypertrophy, tonsillar hypertrophy, snoring
Danish: Almindelig: Søvnapnø-syndrom, adenoid hypertrofi, tonsillær hypertrofi, snorken
English: Other medicines and INCRELEX
Danish: Brug af anden medicin sammen med INCRELEX
English: Infections Infections of the middle ear have been observed in children with mecasermin treatment.
Danish: Infektioner Mellemørebetændelse er observeret hos børn i behandling med mercasermin.
English: Figure 2: Inject air into vial
Danish: Figur 2: Sprøjt luft i hætteglasset
English: Hair loss has also been reported following mecasermin use.
Danish: Hårtab (alopeci) Hårtab er også rapporteret efter brug af mecasermin.
English: Mecasermin may lower blood sugar levels.
Danish: Mercasermin kan sænke blodsukkeret.
English: The total IGF-1 volume of distribution (mean ± SD) after subcutaneous administration of INCRELEX in 12 subjects with severe Primary IGFD is estimated to be 0.257 (± 0.073) l/kg at a mecasermin dose of 0.045 mg/kg, and is estimated to increase as the dose of mecasermin increases.
Danish: Det samlede IGF-1-fordelingssvolumen (middel ± SD) efter subkutan indgivelse af INCRELEX hos 12 patienter med svær primær IGFD anslås til at være 0,257 (± 0,073) l/kg ved en mecasermindosis på 0,045 mg/kg, og det anslås, at denne værdi øges i takt med, at mecasermin-dosis øges.
English: Therapy should be discontinued if evidence of neoplasia develops.
Danish: Behandlingen skal seponeres, hvis der opstår tegn på neoplasi.
English: Before you take the needle out of the vial, check the syringe for air bubbles.
Danish: Inden du trækker kanylen ud af hætteglasset, skal du kontrollere, om der er luftbobler i sprøjten.
English: - INCRELEX is a liquid that contains mecasermin which is a man-made insulin-like growth factor-1 (IGF-1), which is similar to the IGF-1 made by your body.
Danish: - INCRELEX er en væske, der indeholder mecasermin, som er en menneskeskabt insulinlignende vækstfaktor-1 (IGF-1), som ligner den IGF-1, som din krop selv danner.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere information om INCRELEX findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Use syringes and needles only once.
Danish: Sprøjten og kanylen må kun bruges én gang.
English: Parents and patients should be informed that such reactions are possible and that if a systemic allergic reaction occurs, treatment should be interrupted and prompt medical attention should be sought.
Danish: Forældre og patienter skal informeres om, at sådanne reaktioner kan forekomme, og at behandlingen skal afbrydes og lægen straks kontaktes, hvis en systemisk allergisk reaktion forekommer.
English: • To inform parents and patients that systemic allergic reactions are possible and that if this occurs treatment should be interrupted and prompt medical attention should be sought.
Danish: • Forældre og patienter skal informeres om, at systemiske allergiske reaktioner kan forekomme, og at behandlingen skal afbrydes og lægen straks kontaktes, hvis dette forekommer.
English: Via del Bosco Rinnovato n. 6 Milanofiori Nord Palazzo U7 20090 Assago (Mi) Tel: + 39 - 02 - 39 22 41
Danish: Via del Bosco Rinnovato n. 6 Milanofiori Nord Palazzo U7 20090 Assago (Mi)
English: Mecasermin has been tested in a rat teratology study with no effects on fœtus up to 16 mg/kg (20 fold the maximum recommended human dose (MRHD) based on body surface area) and in a rabbit teratology with no effects on foetus at dose of 0.5 mg/kg (2 fold the MRHD based on body surface area).
Danish: Mecasermin er blevet testet i et teratologistudie med rotter uden påvirkning af fosteret ved doser op til 16 mg/kg (20 gange den maksimalt anbefalede humane dosis [MRHD] baseret på legemsoverfladen) og i et teratologistudie med kaniner uden påvirkning af fosteret ved doser på 0,5 mg/kg (2 gange MRHD baseret på legemsoverfladen).
English: Mecasermin should be administered shortly before or after a meal or snack, because it may have insulin-like hypoglycaemic effects.
Danish: Mecasermin skal indgives umiddelbart inden eller efter et måltid eller mellemmåltid, da midlet kan have insulinlignende hypoglykæmiske effekter.
English: Mecasermin therapy should be discontinued if pregnancy occurs.
Danish: Behandling med mercasermin skal afbrydes i tilfælde af graviditet.
English: Change the injection site for each injection.
Danish: Skift indgivelsessted for hver indsprøjtning.
English: Other adverse reactions have been identified during post approval use of INCRELEX.
Danish: Der er blevet identificeret andre bivirkninger under brug af INCRELEX efter markedsføringen.
English: If you are using a new vial, remove the protective cap. Do not remove the rubber stopper.
Danish: Hvis du tager hul på et nyt hætteglas skal du fjerne beskyttelseshætten.
English: Mecasermin is a human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology.
Danish: Mecasermin er en human, insulinlignende vækstfaktor-1 (rhIGF-1), fremstillet ved hjælp af rekombinant DNA-teknologi.
English: Ipsen SpA
Danish: Italia Ipsen SpA
English: Figure 4: Tip in liquid
Danish: Figur 4: Kanylespidsen i væsken
English: Put the needle through the rubber top of the vial and push the plunger to inject air into the vial (see Figure 2).
Danish: Stik kanylen igennem hætteglassets gummitop, og skub stemplet ind for at sprøjte luft i hætteglasset (se figur 2).
English: Reactions observed in the clinical trials
Danish: Bivirkninger i de kliniske forsøg
English: • Long-term toxicity in patients undergoing developmental changes
Danish: • Toksicitet på langt sigt hos patienter, der ændrer sig udviklingsmæssigt • Eventuel forekomst af maligniteter samt andre risici
English: Lymphoid tissue (e.g., tonsillar) hypertrophy associated with complications, such as snoring, sleep apnoea, and chronic middle-ear effusions have been reported with the use of this medicinal product.
Danish: Hypertrofi i lymfevæv (f.eks. tonsiller) forbundet med komplikationer, såsom snorken, søvnapnø og kronisk mellemøreeffusion, er rapporteret ved anvendelse af dette lægemiddel.
English: INCRELEX should be administered using sterile disposable syringes and injection needles.
Danish: INCRELEX skal indgives med sterile engangssprøjter og injektionskanyler.
English: Common: Papilloedema
Danish: Almindelig: Papilødem
English: For further information ask the doctor.
Danish: Spørg lægen, hvis du ønsker yderligere oplysninger.
English: The use of this medicine has not been studied in children under 2 years of age and is therefore not recommended.
Danish: Anvendelsen af dette lægemiddel er ikke blevet undersøgt hos børn under 2 år, og INCRELEX bør derfor ikke anvendes til denne patientgruppe.
English: There are limited data concerning the pharmacokinetics of mecasermin in children with hepatic impairment, in this specific population of severe primary IGFD patients.
Danish: Der er begrænsede data vedrørende farmakokinetikken for mecasermin hos børn med nedsat leverfunktion i denne specifikke population af patienter med svær primær IGFD.
English: Throw them away properly in a sharps container (such as a biohazard container), hard plastic container (such as a detergent bottle), or metal container (such as an empty coffee can).
Danish: Kassér dem på korrekt vis i en beholder til skarpe genstande (f.eks. en beholder til miljøfarligt affald), en beholder af hård plast (f.eks. en flaske, hvor der har været rengøringsmiddel i) eller en metalbeholder (f.eks. en tom kaffedåse).
English: What INCRELEX looks like and contents of the pack INCRELEX is a clear and colourless solution for injection (injection) supplied in a glass vial closed with a stopper and a seal.
Danish: INCRELEX er en klar og farveløs injektionsvæske, leveret i et hætteglas, der er lukket med en prop og forseglet.
English: Systemic hypersensitivity included symptoms such as anaphylaxis, generalized urticaria, angioedema and dyspnoea.
Danish: Systemisk hypersensitivitet omfatter symptomer så som anafylaksi, generaliseret urticaria, angioødem og dyspnø.
English: At the time of initial prescription, physicians should educate parents on the signs, symptoms and treatment of hypoglycaemia, including injection of glucagon.
Danish: Ved den første ordination skal lægen oplyse patienten om tegn, symptomer og behandling af hypoglykæmi, herunder injektion af glukagon.
English: Aqueous, clear and colourless solution.
Danish: Vandig, klar og farveløs væske.
English: For severe hypoglycaemia, if you are not responsive and cannot drink sugar-containing fluids, you should give an injection of glucagon.
Danish: Ved alvorlige tilfælde af lavt blodsukker, hvor du ikke reagerer og ikke kan drikke sukkerholdig væske, skal du give en indsprøjtning med glukagon.
English: If the patient is not awake or alert enough to drink sugarcontaining fluids, an injection of glucagon into the muscle may be necessary to reverse the low blood sugar.
Danish: Hvis du/dit barn ikke er ved bevidsthed eller ikke er vågen nok til at kunne drikke sukkerholdig væske, kan det være nødvendigt at indsprøjte glukagon i musklen for at afhjælpe det lave blodsukker.
English: • Instructions to report the onset or worsening of snoring that may indicate an increase in growth of tonsils and/or adenoids following the beginning of treatment with INCRELEX.
Danish: • Vejledning i at rapportere en begyndende eller en forværret snorken, efter behandlingsstart med INCRELEX.
English: Common: Thymus hypertrophy
Danish: Almindelig: Thymushypertrofi
English: Other ingredients: benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate and water for injections.
Danish: Hjælpestoffer: benzylalkohol, natriumchlorid, polysorbat 20, eddikesyre, natriumacetat og vand til injektionsvæsker.
English: There are limited data concerning the pharmacokinetics of mecasermin in children with renal impairment, in this specific population of severe primary IGFD patients.
Danish: Der er begrænsede data vedrørende farmakokinetikken for mecasermin hos børn med nedsat nyrefunktion i denne specifikke population af patienter med svær primær IGFD.
English: Pain in muscles has also been seen with mecasermin treatment.
Danish: Smerter i muskler er også blevet set ved behandling med mercasermin.
English: Intracranial hypertension (IH) with papilloedema, visual changes, headache, nausea and/or vomiting has been reported in patients treated with mecasermin, as has been reported with therapeutic GH administration.
Danish: Der er rapporter om intrakraniel hypertension (IH) med papilødem, synsforstyrrelser, hovedpine, kvalme og/eller opkastning hos patienter i behandling med mecasermin, ligesom det også er rapporteret ved terapeutisk GH-indgivelse.
English: *Mecasermin is a recombinant DNA-derived human insulin-like growth factor-1(IGF-1) produced in Escherichia coli.
Danish: *Mecasermin er en rekombinant, DNA-afledt, human, insulinlignende vækstfaktor-1(IGF-1), fremstillet i Escherichia coli.
English: Mecasermin has no effects on fertility in rats using intravenous doses 0.25, 1, and 4 mg/day (up to 4 times the clinical exposure with the MRHD based on AUC).
Danish: Mecasermin har ingen virkning på fetiliteten hos rotter ved brug af intravenøse doser på 0,25, 1 og 4 mg/dag (op til 4 gange den kliniske eksponering med MRHD baseret på AUC).
English: Women of childbearing potential / Contraception in males and females A negative pregnancy test is recommended for all women of child bearing potential prior to treatment with mecasermin.
Danish: Kvinder i den fertile alder/kontraception til mænd og kvinder Det anbefales, at der foreligger en negativ graviditetstest for alle kvinder i den fertile alder forud for behandling med mecasermin.
English: Precaution to be taken before manipulating or administering the medicinal product The solution should be clear immediately after removal from the refrigerator.
Danish: Opløsningen skal være klar umiddelbart efter at den tages ud af køleskabet.
English: Doses of insulin and/or other hypoglycaemic medicinal products may need to be reduced (see section 4.4).
Danish: Insulindoser og/eller doser af andre hypoglykæmiske lægemidler skal muligvis reduceres (se pkt.
English: • That INCRELEX should be administered shortly before or after a meal or snack because it has insulin-like hypoglycaemic effects.
Danish: • INCRELEX skal indgives umiddelbart inden eller efter et måltid eller mellemmåltid, da midlet har insulinlignende hypoglykæmiske effekter.
English: Treatment of acute overdose of mecasermin should be directed at alleviating any hypoglycaemic effects.
Danish: Behandlingen af en akut overdosering af mecasermin skal rettes mod afhjælpning af hypoglykæmiske effekter.
English: If you take INCRELEX, you should avoid participating in high risk activities (such as vigorous physical activity) within 2 to 3 hours after INCRELEX injection, especially at the beginning of INCRELEX treatment.
Danish: Hvis du tager INCRELEX, skal du undgå at deltage i høj-risiko-aktiviteter (såsom voldsom fysisk aktivitet) 2-3 timer efter en INCRELEX-indsprøjtning.
English: The dose of INCRELEX should not be doubled to make up for one or more omitted doses.
Danish: INCRELEX-dosis må aldrig fordobles for at erstatte en eller flere glemte doser.
English: Increased blood sugar (hyperglycaemia) Increased blood sugar has also been observed with mecasermin treatment.
Danish: For højt blodsukker (hyperglykæmi) Der har også været tilfælde af for højt blodsukker under behandling med mercasermin.
English: A swelling at the back of the eye (due to increased pressure within the brain) may be observed by a doctor or optician during mecasermin treatment.
Danish: Lægen eller en optiker kan observere en hævelse bagerst i øjet (på grund af forhøjet tryk i hjernen) under behandling med mercasermin.
English: Used needle and syringe should be placed in a sharps container (such as a biohazard container), hard plastic container (such as a detergent bottle), or metal container (such as an empty coffee can).
Danish: Brugte kanyler og sprøjter skal anbringes i en beholder til skarpe genstande (f.eks. en beholder til miljøfarligt affald), en beholder af hård plast (f.eks. en flaske, hvor der har været rengøringsmiddel i) eller en metalbeholder (f.eks. en tom kaffedåse).
English: Very common: Vomiting, upper abdominal pain
Danish: Meget almindelig: Opkastning, øvre abdominale smerter Almindelig: Abdominalsmerter
English: Mecasermin should not be administered to a breast-feeding mother.
Danish: Mercasermin må ikke gives til en ammende moder.
English: Bone/Mineral Metabolism
Danish: Knogle-/mineralstofskifte
English: Ipsen Farmaceutica B.V. Taurusavenue 33 B NL-2132 LS Hoofddorp Tel: + 31 23 55 41 600
Danish: Taurusavenue 33 B NL-2132 LS Hoofddorp Tel: + 31 23 55 41 600
English: An increased incidence of adrenal medullary hyperplasia and pheochromocytoma was observed in male rats at doses of 1 mg/kg/day and above ( 1 times the clinical exposure with the maximum recommended human dose [MRHD] based on AUC) and female rats at all dose levels ( 0.3 times the clinical exposure with the MRHD based on AUC).
Danish: En øget forekomst af adrenal medullær hyperplasi og pheochromocytom blev observeret hos hanrotter ved doser på 1 mg/kg/dag og derover ( 1 gange den kliniske eksponering med den maksimale anbefalede humane dosis [MRHD], baseret på AUC) og hunrotter ved alle dosisniveauer ( 0,3 gange den kliniske eksponering med MRHD baseret på AUC).
English: Pull the plunger to withdraw the correct dose into the syringe (see Figure 5).
Danish: Træk stemplet tilbage, og træk den korrekte dosis op i sprøjten (se figur 5).
English: What you need to know before you use INCRELEX
Danish: Det skal du vide, før du begynder at tage INCRELEX
English: Leave the syringe in the vial and turn both upside down.
Danish: Lad sprøjten sidde i hætteglasset, og vend bunden i vejret på dem begge.
English: Treatment success should be evaluated based on height velocities.
Danish: Væksthastigheder bør danne grundlag for evaluering af behandlingssucces.
English: Acute overdose could lead to hypoglycaemia (low blood sugar).
Danish: En akut overdosering kan medføre lavt blodsukker (hypoglykæmi).
English: What INCRELEX contains - The active substance is mecasermin.
Danish: - Aktivt stof: mecasermin.
English: Some signs of enlarged tonsils/adenoids include: snoring, difficulty breathing or swallowing, sleep apnoea (a condition where breathing stops briefly during sleep), or fluid in the middle ear, as well as infections of the ear.
Danish: Tegn på forstørrede mandler/polypper kan være snorken, besvær med at trække vejret eller synke, søvnapnø (en tilstand, hvor du kortvarigt holder op med at trække vejret, mens du sover), væske i mellemøret og mellemørebetændelse.