FrancophonIA/ELRC3.0 huggingface dataset:
English: Growth and metabolism of epiphyseal plate cells are directly stimulated by GH and IGF-1.
Danish: Vækst og metabolisme i epifyseskivernes celler stimuleres direkte af GH og IGF-1.
English: Intracranial hypertension/increased intracranial pressure occurred in 4 (0.96%) of patients from the clinical trials and occurred in 7 - 9 year old treatment naïve subjects.
Danish: Intrakraniel hypertension/forhøjet intrakranielt tryk forekom hos 4 (0,96 %) af patienterne i de kliniske forsøg og forekom hos behandlingsnaive forsøgspersoner på 7-9 år.
English: Stop INCRELEX immediately and seek urgent medical advice if you develop a serious allergic reaction.
Danish: Du skal øjeblikkeligt stoppe med at tage INCRELEX og straks søge læge, hvis du får en alvorlig allergisk reaktion.
English: Typically these were pruritus and urticaria.
Danish: Disse var typisk pruritus og urticaria.
English: Such containers should be sealed and disposed of properly in the way your doctor described.
Danish: Disse beholdere skal lukkes og kasseres på korrekt vis, som lægen har vist dig.
English: Doses greater than 0.12 mg/kg given twice daily have not been evaluated in children with severe Primary IGFD.
Danish: Doser på mere end 0,12 mg/kg to gange daglig er ikke blevet evalueret hos børn med svær primær IGFD.
English: Before beginning treatment with INCRELEX the doctor or nurse will explain to you how to treat hypoglycaemia.
Danish: Inden du begynder behandlingen med INCRELEX, vil lægen eller sygeplejersken forklare dig, hvordan du skal behandle lavt blodsukker.
English: Mecasermin, like insulin, may lower blood sugar levels (see hypoglycaemia in section 4).
Danish: Mecasermin kan, ligesom insulin, sænke sukkerniveauet i blodet (se hypoglykæmi i afsnit 4).
English: The most frequently reported adverse reactions from the clinical trials were headache (44%), hypoglycaemia (28%), vomiting (26%), injection site hypertrophy (17%), and otitis media (17%).
Danish: De oftest rapporterede bivirkninger i de kliniske forsøg var hovedpine (44 %), hypoglykæmi (28 %), opkastning (26 %), hypertrofi på injektionsstedet (17 %) og otitis media (17 %).
English: See the ‘Instructions for Use' at the end of this leaflet.
Danish: Se ‘Brugsanvisning' sidst i indlægssedlen.
English: • Instructions to change and rotate the site of injection for each injection to avoid the development of lipohypertrophy.
Danish: • Vejledning i at skifte og rotere injektionssted for hver injektion for at undgå udvikling af lipohypertrofi.
English: - if you have finished growing (the bone growth plates are closed).
Danish: - Hvis du er færdigudvokset (knoglevækstskiverne er lukkede).
English: Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment.
Danish: Svær primær IGFD omfatter patienter med mutationer i GH-receptoren (GHR), post-GHR signalsti og IGF-1-gendefekter; disse er ikke GH-insufficiente og kan derfor ikke forventes at reagere tilstrækkeligt på eksogen GH-behandling.
English: No studies have been conducted to determine the effect of hepatic impairment on the pharmacokinetics of mecasermin.
Danish: Der er ikke gennemført studier med henblik på at fastslå effekt af nedsat leverfunktion på de farmakokinetiske egenskaber ved mecasermin.
English: Inject INCRELEX just under your skin shortly before or after a meal or snack because it may have insulinlike hypoglycaemic effects and so it may decrease blood sugar levels (see hypoglycaemia in section 4).
Danish: Indsprøjt INCRELEX lige under din hud umiddelbart inden eller efter et måltid eller mellemmåltid, da det kan have insulinlignende hypoglykæmiske virkninger og derfor kan sænke sukkerniveauet i blodet (se hypoglykæmi i afsnit 4).
English: Patients with abnormal echocardiogram findings or cardiovascular symptoms should be followed regularly with echocardiogram procedures.
Danish: Patienter med et abnormt ekkokardiogram eller kardiovaskulære symptomer bør følges regelmæssigt med optagelse af ekkokardiogram.
English: Pre-treatment height velocity data were available for 75 subjects.
Danish: Der var væksthastighedsdata fra før behandlingen til rådighed for 75 patienter.
English: Very common (may affect more than 1 in 10 people) Low blood sugar (hypoglycaemia)
Danish: Meget almindelige (forekommer hos flere end 1 ud af 10 patienter) Lavt blodsukker (hypoglykæmi)
English: • The signs and symptoms of hypoglycaemia.
Danish: • Tegn og symptomer på hypoglykæmi.
English: A small number of cases indicative of anaphylaxis requiring hospitalisation have been reported.
Danish: Et lille antal tilfælde, der indikerede anafylaksi og krævede hospitalsindlæggelse, er rapporteret.
English: Do not use after the expiry date (which is stated on the label after EXP and it refers to the last day of the month) or if it is cloudy or if you see bits.
Danish: Den må ikke bruges efter udløbsdatoen (som står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned), eller hvis den er uklar, eller du kan se små korn i den.
English: Breast-feeding while taking INCRELEX is not recommended, because there is insufficient information on the excretion of mecasermin in human milk.
Danish: Amning anbefales ikke ved indtagelse af INCRELEX, da data for udskillelse af mecasermin i human mælk er utilstrækkelige.
English: Persons who have allergic reactions to injected IGF-1, who have unexpectedly high blood values of IGF-1 after injection, or who fail to show a growth response without any identified cause may be having an antibody response to injected IGF-1.
Danish: Personer, der får allergiske reaktioner mod injiceret IGF-1, der har uventede høje blodværdier af IGF1 efter injektion, eller der ikke udviser et respons i vækst, kan have en antistofrespons på injiceret IGF-1.
English: Doses of insulin and/or other hypoglycaemic medicinal products may need to be reduced for diabetic subjects using this medicinal product.
Danish: Insulindoser og/eller andre doser af hypoglykæmiske lægemidler skal muligvis reduceres hos diabetikere, der får dette lægemiddel.
English: Thyroid and nutritional deficiencies should be corrected before initiating mecasermin treatment.
Danish: Thyroid- og ernæringsforstyrrelser skal afhjælpes, inden en behandling med mecasermin indledes.
English: Mecasermin was administered subcutaneously to Sprague Dawley rats at doses of 0, 0.25, 1, 4, and 10 mg/kg/day for up to 2 years.
Danish: Mecasermin blev indgivet subkutant til Sprague Dawley-rotter ved doser på 0, 0,25, 1, 4 og 10 mg/kg/dag i op til 2 år.
English: - if you have a localised reaction at the injection site or generalised allergic reaction with INCRELEX.
Danish: - Hvis du får en lokal reaktion på injektionsstedet eller en allergisk reaktion, der breder sig til hele kroppen med INCRELEX.
English: Figure B: Press (don't rub) with gauze or cotton
Danish: Figur B: Tryk med gaze eller vat (må ikke gnides)
English: A disruption or early ending of treatment with mecasermin may impair the success of the growth therapy.
Danish: Afbrydelse eller for tidligt ophør med behandlingen med mercasermin kan påvirke vækstbehandlingens udfald.
English: P-value for change from pre-Tx [1]
Danish: P-værdi for ændring fra pre-Tx [1]
English: During clinical trials in other indications totalling approximately 300 patients, reports of local and/or systemic hypersensitivity were received for 8% of patients.
Danish: I kliniske forsøg med andre indikationer, der inkluderede ca. 300 patienter, blev der rapporteret lokal og/eller systemisk hypersensivitet hos 8% af patienterne.
English: INCRELEX contains benzyl alcohol and sodium
Danish: INCRELEX indeholder benzylalkohol og natrium
English: The metabolic actions of IGF-1 are in part directed at stimulating the uptake of glucose, fatty acids, and amino acids so that metabolism supports growing tissues.
Danish: De metaboliske virkninger af IGF-1 er delvist rettet mod stimulering af optagelsen af glukose, fedtsyrer og aminosyrer, således at metabolismen understøtter vævsvæksten.
English: Instructions on the treatment of hypoglycaemia.
Danish: Vejledning i behandling af hypoglykæmi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/402/001
Danish: EU/1/07/402/001
English: Talk to your doctor or pharmacist before using INCRELEX - if you have a curved spine (scoliosis).
Danish: Kontakt lægen eller apotekspersonalet, før du tager INCRELEX - Hvis du har en krum rygsøjle (skoliose).
English: You should always have a source of sugar such as orange juice, glucose gel, sweets, or milk available in case symptoms of hypoglycaemia occur.
Danish: Du skal altid have en sukkerkilde, såsom appelsinjuice, glukosegel, slik eller mælk, på dig, hvis der skulle opstå symptomer på lavt blodsukker.
English: Hypoglycaemia was the most frequently reported adverse event and a proper attention has to be given to meals in relation to dosing.
Danish: Hypoglykæmi var den hyppigst rapporterede bivirkning, og det er nødvendigt at være opmærksom på måltider i forhold til dosering.
English: If it is present, your doctor may decide to temporarily reduce or discontinue mecasermin therapy.
Danish: Hvis dette er tilfældet, kan lægen eventuelt beslutte midlertidigt at nedsætte dosis eller afbryde behandlingen med mecasermin.
English: If a person with severe hypoglycemia is unconscious or otherwise unable to ingest food normally, an injection of glucagon may be required.
Danish: Hvis en person med svær hypoglykæmi er bevidstløs eller på anden måde er ude af stand til at indtage føden normalt, kan en injektion af glukagon være påkrævet.
English: An enlarged thymus (a specialized organ of the immune system) has been observed with mecasermin treatment.
Danish: Der er rapporteret om forstørret thymus (et specialiseret organ i immunsystemet) ved behandling med mercasermin.
English: Insulin-like growth factor-1 (IGF-1) is the principal hormonal mediator of statural growth.
Danish: Insulinlignende vækstfaktor-1 (IGF-1) er den primære hormonelle mediator for højdevækst.
English: IGFBP-3 is reduced in subjects with severe Primary IGFD, resulting in increased clearance of IGF-1 in these subjects relative to healthy subjects.
Danish: IGFBP-3 reduceres hos patienter med svær primær IGFD, hvilket resulterer i en øget IGF-1-clearance hos disse personer i forhold til raske personer.
English: Patients should have examinations periodically and at the occurrence of clinical symptoms to rule out such potential complications or to initiate appropriate treatment.
Danish: Patienter skal undersøges med regelmæssige mellemrum og ved forekomst af kliniske symptomer for at udelukke sådanne potentielle komplikationer eller for at iværksætte en passende behandling.
English: Never share needles and syringes.
Danish: Del aldrig kanyler og sprøjter med andre.
English: For subjects with bone age available for at least 6 years after treatment initiation, the mean increase in bone age was comparable to the mean increase in chronological age; for these subjects, there does not appear to be any clinically significant advance of bone age relative to chronological age.
Danish: For patienter med tilgængelig knoglealder i mindst 6 år efter iværksættelse af behandling var middeløgningen i knoglealder sammenlignelig med middeløgningen i kronologisk alder. For disse patienter så der ikke ud til at være noget klinisk signifikant fremrykning i knoglealder i forhold til kronologisk alder.
English: SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSEN AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER SÆRLIGE OMSTÆNDIGHEDER
English: In blood, IGF-1 is bound to six IGF binding proteins (IGFBPs), with ~80% bound as a complex with IGFBP-3 and an acid-labile subunit.
Danish: IGF-1 bindes i blod til seks IGF-bindende proteiner (IGFBP'er) med ~80 % bundet som et kompleks med IGFBP-3 og en syrelabil underenhed.
English: Get medical help immediately if you have a generalised allergic reaction (hives, trouble breathing, faintness or collapse and feeling generally unwell).
Danish: Søg straks lægehjælp, hvis du får en allergisk reaktion, der involverer hele kroppen (nældefeber, problemer med at trække vejret, besvimelse eller kollaps og en generel følelse af utilpashed).
English: Check the liquid to make sure it is clear and colourless.
Danish: Kontrollér, om væsken er klar og farveløs.
English: Adverse reaction data was taken from a total of 413 clinical trial patients with severe Primary IGFD.
Danish: Data vedrørende bivirkninger blev taget fra kliniske forsøg med i alt 413 patienter med svær primær IGFD.
English: IGF-1 suppresses hepatic glucose production, stimulates peripheral glucose utilization, and can reduce blood glucose and cause hypoglycaemia.
Danish: IGF-1 undertrykker glukoseproduktion i leveren, stimulerer perifer glukoseudnyttelse og kan reducere blodglukose og medføre hypoglykæmi.
English: Please ask the doctor for advice before stopping the treatment.
Danish: Tal med lægen, inden du holder op med behandlingen.
English: Tell the doctor if you develop hearing problems.
Danish: Fortæl det til lægen, hvis du får problemer med hørelsen.
English: If no significant adverse reactions occur for at least one week, the dose may be raised in increments of 0.04 mg/kg to the maximum dose of 0.12 mg/kg given twice daily.
Danish: Hvis der ikke forekommer signifikante bivirkninger i mindst en uge, kan dosis øges i trin på 0,04 mg/kg op til den maksimale dosis på 0,12 mg/kg to gange daglig.
English: A negative pregnancy test and adequate contraception is required in all pre-menopausal women receiving INCRELEX.
Danish: En negativ graviditetstest og passende prævention er påkrævet hos alle præ-menopausale kvinder, som får INCRELEX.
English: The syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy.
Danish: Sprøjterne skal have et tilstrækkeligt lille volumen til, at den ordinerede dosis kan trækkes op af hætteglasset med rimelig nøjagtighed.
English: Therefore, this medicinal product is not recommended in children below age of 2.
Danish: Dette lægemiddel frarådes derfor til børn under 2 år.
English: It is recommended that the dose be individualised for each patient as described under posology
Danish: Det anbefales, at dosis tilpasses individuelt for hver patient som beskrevet under dosering
English: Slowly push in the plunger of the syringe all the way, making sure you have injected all the liquid.
Danish: Skub forsigtigt sprøjtestemplet helt ind, og sørg for, at du har indsprøjtet al væsken.
English: Any patient with the onset of a limp or complaint of hip or knee pain should be evaluated.
Danish: Enhver patient, der begynder at halte eller klager over smerter i hofte eller knæ, skal evalueres.
English: • Slipped capital femoral epiphysis and progression of scoliosis can occur in patients who experience rapid growth.
Danish: • Forskudt caput femoralis epifyser og udvikling af skoliose kan forekomme hos patienter, som oplever hurtig vækst.
English: There were also reports of local allergic reactions at the injection site.
Danish: Der var også tilfælde af lokale allergiske reaktioner på injektionsstedet.
English: The amino acid sequence of the product is identical to that of endogenous human IGF-1.
Danish: Aminosyresekvensen i produktet er identisk med endogen human IGF-1.
English: The lowest dose that was associated with substantial growth increases on an individual basis was 0.04 mg/kg twice daily (BID).
Danish: Den laveste dosis, der blev associeret med væsentlig individuel vækstforøgelse, var 0,04 mg/kg to gange daglig (BID).
English: INCRELEX should be administered by subcutaneous injection shortly before or after a meal or snack.
Danish: INCRELEX skal indgives ved subkutan injektion umiddelbart inden eller efter et måltid eller mellemmåltid.
English: If hypoglycaemia occurs with recommended doses, despite adequate food intake, the dose should be reduced.
Danish: Hvis der trods passende fødeindtag opstår hypoglykæmi ved de anbefalede doseringer, skal dosis reduceres.
English: During clinical trials in other indications (totaling approximately 300 patients) 8% of patients reported a local and/or systemic hypersensitivity reactions.
Danish: I kliniske forsøg med andre indikationer (i alt ca. 300 patienter) rapporterede 8% af patienterne en lokal og/eller systemisk hypensensivitets reaktion.
English: • To perform a routine funduscopic examination prior to beginning treatment and periodically during treatment or at the occurrence of clinical symptoms.
Danish: • Der skal udføres en rutinemæssig fundoskopi inden behandlingsstart og med regelmæssige mellemrum under behandlingen eller ved forekomst af kliniske symptomer.
English: Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Danish: Benzylalkohol kan medføre toksiske reaktioner og anafylaktoide reaktioner hos spædbørn og børn under 3 år.
English: The absolute subcutaneous bioavailability of mecasermin in severe Primary IGFD subjects has not been determined.
Danish: Den absolutte subkutane biotilgængelighed af mecasermin hos patienter med svær primær IGFD er ikke blevet fastlagt.
English: Hypoglycaemia is a very common adverse reaction.
Danish: Hypoglykæmi er en meget almindelig bivirkning.
English: Elderly The pharmacokinetics of INCRELEX have not been studied in subjects greater than 65 years of age.
Danish: Ældre De farmakokinetiske egenskaber ved INCRELEX er ikke undersøgt hos patienter over 65 år.
English: Pharmacodynamic effects The following actions have been demonstrated for endogenous human IGF-1:
Danish: Farmakodynamisk virkning Følgende virkninger er påvist for endogen, human IGF-1:
English: Mean (SD) for change from pre-Tx
Danish: Middel (SD) for ændring fra pre-Tx
English: - The other ingredients are: benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate and water for injections (see section 2 "INCRELEX contains benzyl alcohol and sodium").
Danish: - Øvrige indholdsstoffer: Benzylalkohol, natriumchlorid, polysorbat 20, koncentreret eddikesyre, natriumacetat og vand til injektionsvæsker (se punkt 2 ”INCRELEX indeholder benzylalkohol og natrium”).
English: Excipients INCRELEX contains 9 mg/ml benzyl alcohol as a preservative.
Danish: Hjælpestoffer INCRELEX indeholder 9 mg/ml benzylalkohol som konserveringsmiddel.
English: Funduscopic examination is recommended at the initiation, periodically during the course of mecasermin therapy and at the occurrence of clinical symptoms.
Danish: Fundoskopi anbefales ved behandlingsstart, med regelmæssige mellemrum i løbet af behandlingen med mecasermin og ved forekomst af kliniske symptomer.
English: It is also recommended that all women of childbearing potential use adequate contraception during treatment.
Danish: Det anbefales også, at alle kvinder i den fødedygtige alder bruger passende prævention under behandlingen.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03 August 2007
Danish: Dato for første markedsføringstilladelse: 3. august 2007 Dato for seneste fornyelse: 3. august 2012
English: Follow the doctor's instructions for throwing away the needle and syringe.
Danish: Følg din læges anvisninger for bortskaffelse af kanyle og sprøjte.
English: Other uncommon side effects seen with mecasermin treatment include depression, nervousness.
Danish: Andre ikke almindelige bivirkninger under behandling med mercasermin omfatter depression og nervøsitet.
English: If bubbles are in the syringe, hold the vial and syringe with needle straight up and tap the side of the syringe until the bubbles float to the top.
Danish: Hvis der er bobler i sprøjten, skal du holde hætteglasset og sprøjten med nålen helt lodret og banke let på siden af sprøjten, indtil boblerne flyder op til overfladen.
English: The recommended starting dose of mecasermin is 0.04 mg/kg of body weight twice daily by subcutaneous injection.
Danish: Den anbefalede startdosis af mecasermin er 0,04 mg pr. kg legemsvægt to gange daglig ved subkutan injektion.
English: Insert the needle in the way the doctor showed you.
Danish: Indfør kanylen, som lægen har vist dig.
English: Table 2: Annual Height Results by Number of Years Treated with INCRELEX Pre-Tx Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8
Danish: Pre-Tx År 1 År 2 År 3 År 4 År 5 År 6 År 7 År 8
English: INCRELEX contains benzyl alcohol as a preservative which may cause toxic reactions and allergic reactions in infants and children up to 3 years old.
Danish: INCRELEX indeholder benzylalkohol, som konserveringsmiddel, hvilket kan medføre forgiftning og allergiske reaktioner hos spædbørn og børn under 3 år.
English: Not known: Systemic hypersensitivity (anaphylaxis, generalized urticaria, angioedema, dyspnoea), local allergic reactions at the injection site (pruritus, urticaria)
Danish: Ikke kendt: Systemisk hypersensitivitet (anafylaksi, generaliseret urticaria, angioødem, dyspnø), lokale allergiske reaktioner ved injektionsstedet (pruritus, urticaria)
English: The dose of 120 μg/kg given subcutaneously (SC) and twice daily (BID) was associated with the greatest growth responses.
Danish: En dosis på 120 μg/kg subkutant (s.c.) to gange daglig (BID) var forbundet med det største vækstrespons.
English: Subcutaneous doses of mecasermin, generally ranging from 60 to 120 g/kg given twice daily (BID), were administered to 92 paediatric subjects with severe Primary IGFD.
Danish: Subkutane doser af mecasermin, generelt varierende fra 60 til 120 g/kg indgivet to gange daglig, blev indgivet til 92 pædiatriske patienter med svær primær IGFD.
English: If the overdose results in loss of consciousness, intravenous glucose or parenteral glucagon may be required to reverse the hypoglycaemic effects.
Danish: Hvis overdoseringen medfører bevidstløshed, kan det være nødvendigt at indgive intravenøs glukose eller parenteral glukagon for at modvirke de hypoglykæmiske effekter.
English: The dose of mecasermin should never be increased to make up for one or more omitted doses.
Danish: Mecasermin-dosis må aldrig øges for at erstatte en eller flere glemte doser.
English: Patients should avoid engaging in any high-risk activities within 2-3 hours after dosing, particularly at the initiation of mecasermin treatment, until a welltolerated dose of INCRELEX has been established.
Danish: Patienter skal undgå høj-risiko-aktiviteter i 2-3 timer efter doseringen, især i begyndelsen af mecasermin-behandlingen, indtil en veltolereret INCRELEX dosis er fastlagt.
English: Clearance of total IGF-1 is inversely proportional to serum IGFBP-3 levels and total IGF-1 systemic clearance (CL/F) is estimated to be 0.04 l/hr/kg at 3 mg/l IGFBP-3 in 12 subjects.
Danish: Clearance af total IGF-1 er omvendt proportional med serum IGFBP-3-niveauer, og total systemisk IGF-1-clearance (CL/F) anslås til at være 0,04 l/t/kg ved 3 mg/l IGFBP-3 hos 12 patienter.
English: 65, quai Georges Gorse 92100 Boulogne-Billancourt France
Danish: 65, quai Georges Gorse 92100 Boulogne-Billancourt Frankrig
English: Mecasermin may enlarge your tonsils/adenoids.
Danish: Mercasermin kan forstørre dine mandler/polypper.
English: What you need to know before you use INCRELEX 3.
Danish: Det skal du vide, før du begynder at tage INCRELEX 3.
English: • To report the onset of severe headache, blurred vision and associated nausea and vomiting to their physician.
Danish: • Rapportering af alvorlig hovedpine, sløret syn og dermed forbundet kvalme og opkastning til lægen.
English: Push the bubbles out with the plunger and draw liquid back in until you have the correct dose (see Figure 6).
Danish: Skub boblerne ud med stemplet, og træk væske tilbage, indtil du har den korrekte dosis (se figur 6).
English: Mecasermin may be started again after the episode is over.
Danish: Behandlingen med mecasermin kan startes igen, når bivirkningen er overstået.