FrancophonIA/ELRC3.0 huggingface dataset:
English: The percentage contributions of these routes to total metabolism are 42%, 41% and 17%, respectively, but with considerable variability between individuals.
Danish: De procentvise bidrag fra disse metaboliseringsveje til total metabolisme er henholdsvis 42 %, 41 % og 17 %, men med betydelig forskel mellem enkeltindivider.
English: • If your child has diabetes: in this case, your child's blood sugar level should be measured more frequently.
Danish: • Hvis dit barn har diabetes: I dette tilfælde bør dit barns blodsukkerniveau måles mere ofte.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Danish: Indberetning af formodede bivirkninger efter godkendelse af lægemidlet er vigtigt.
English: Never change the dose you are giving to your child yourself.
Danish: Du må ikke selv ændre den dosis, du giver dit barn.
English: • Dosing is based on your baby's weight following the scheme below: Weeks (daily dose)
Danish: • Doseringen er baseret på dit barns vægt i henhold til nedenstående skema: Uge (daglig dosis)
English: • Cold extremities,
Danish: • Kolde ekstremiteter,
English: • Information on the conditions for which HEMANGIOL should not be given
Danish: • Information om de omstændigheder, hvor HEMANGIOL ikke bør gives
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger sammenlignende studier, må dette medicinalprodukt ikke blandes med andre medicinalprodukter.
English: Discontinuation of treatment does not require a progressive decrease in the dose.
Danish: Afbrydelse af behandling kræver ikke en gradvis nedtrapning af dosis.
English: Their frequency is defined using the following conventions: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: Frekvensen er defineret ved hjælp af følgende konventioner: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10); ualmindelig (≥ 1/1000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1000); meget sjælden (< 1/10.000); ukendt (kan ikke estimeres ud fra tilgængelige data).
English: Pregnancy Not relevant.
Danish: Graviditet: Ikke relevant.
English: Due to the clinical trial database size rare and very rare categories are not represented.
Danish: På grund af størrelsen af databasen i det kliniske studie er kategorierne sjælden og meget sjælden ikke repræsenteret.
English: The pharmacokinetic evaluation was performed at steady-state, after 1 or 3 months of treatment.
Danish: Den farmakokinetiske evaluering blev udført ved steady-state efter 1 eller 3 måneders behandling.
English: • The medicine is to be given during or straight after a feed.
Danish: • Lægemidlet skal gives under eller lige efter et måltid.
English: • Tell your doctor before giving this medicine.
Danish: • Fortæl det til din læge, før dette lægemiddel gives.
English: 3 PHARMACEUTICAL FORM
Danish: 3 LÆGEMIDDELFORM
English: Read all of this leaflet carefully before your child starts receiving this medicine because it contains important information.
Danish: Læs denne indlægsseddel grundigt, inden dit barn begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: Continue the treatment at the usual frequency: one dose in the morning and one in the late afternoon.
Danish: Fortsæt behandlingen efter den planlagte frekvens: en dosis om morgenen og en sent på eftermiddagen.
English: • Feed your child regularly to avoid prolonged fast.
Danish: • Mad dit barn jævnligt for at undgå længerevarende faste.
English: This is because HEMANGIOL can change the way other medicines work, and some medicines can have an effect on the way HEMANGIOL works.
Danish: Dette er på grund af, at HEMANGIOL kan ændre måden hvorpå anden medicin virker, og noget medicin kan have indflydelse på, hvordan HEMANGIOL virker.
English: Remove the items from the box
Danish: Tag alle elementer ud af æsker
English: Support and treatment:
Danish: Støtte og behandling:
English: This leaflet was last revised in. Other sources of information
Danish: Denne indlægsseddel blev senest ændret Andre informationskilder
English: Your doctor will advise you on whether you need to stop breastfeeding or not.
Danish: Din læge kan rådgive dig om, hvorvidt du har brug for at afbryde amningen eller ej.
English: Initiation of treatment
Danish: Påbegyndelse af behandlingen
English: After first opening: 2 months.
Danish: Efter første åbning: 2 måneder.
English: It is sometimes called ‘strawberry mark' because the surface of a haemangioma looks a bit like a strawberry.
Danish: Det kaldes somme tider et ”jordbærmærke”, fordi hæmangiomets overflade minder lidt om et jordbær.
English: The educational pack must be available for distribution prior to the launch of the new indication (treatment of proliferating infantile haemangioma) in the Member State.
Danish: Uddannelsespakken skal være tilgængelig før lanceringen af den nye indikation (behandling af proliferende infantil hæmangiom) i medlemsstaterne.
English: • Step 6: Check for air bubbles
Danish: • Trin 6: Tjek for luftbobler
English: • the absence of cardioselective beta-1 beta-blocking activity,
Danish: • fraværet af cardioselektive beta-1 betablokerende aktivitet,
English: • Bronchospasm may develop particularly in patients with asthma.
Danish: • Bronchospasme kan udvikles hos patienter med astma.
English: Pull the plunger of the syringe up to the number of mg you need.
Danish: Træk sprøjtens stempel tilbage til det antal mg, du har brug for.
English: The mixing should be used within 2 hours.
Danish: Blandingen bør anvendes inden for 2 timer.
English: • Somnolence,
Danish: • Somnolens,
English: A. LABELLING
Danish: A. ETIKETTERNG
English: Check the HEMANGIOL dose in milligrams (mg) as prescribed by your doctor.
Danish: Kontrollér dosen af HEMANGIOL i milligram (mg), som ordineret af din læge.
English: If different people are involved, good communication is essential in order to ensure the safety of your child.
Danish: Hvis forskellige personer er involveret, er god kommunikation essentiel for dit barns sikkerhed.
English: • is allergic to propranolol or any of the other ingredients of this medicine (listed in section 6).
Danish: • er allergisk over for propranolol eller et af de øvrige indholdsstoffer i lægemidlet (angivet i punkt 6).
English: Haemangioma can be superficial or deep.
Danish: Hæmangiomet kan være overfladisk eller dybt.
English: Then, your doctor will regularly examine your child during treatment.
Danish: Derefter vil din læge undersøge dit barn med jævne mellemrum i hele behandlingsperioden.
English: For ethical reasons related to the use of placebo, the demonstration of the efficacy was not established in patients with high-risk haemangioma.
Danish: Af etiske årsager relateret til brugen af placebo, blev demonstrationen af effektiviteten ikke fastslået hos patienter med højrisiko hæmangiom.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: This includes any possible side effects not listed in this leaflet.
Danish: Dette gælder også mulige bivirkninger, som ikke er nævnt i denne indlægsseddel.
English: The educational materials for caregivers treating children with HEMANGIOL should include the following key safety elements:
Danish: Uddannelsesmaterialet til plejepersonale, som behandler børn med HEMANGIOL, bør omfatte følgende væsentlige sikkerhedselementer:
English: • an antiarrhythmic effect,
Danish: • en antiarytmisk virkning,
English: Automatism and conduction disorders are expected because of the suppression of sympathetic compensative mechanisms.
Danish: Rytmeforstyrrelser og ledningsforstyrrelser kan forventes på grund af undertrykkelsen af de sympatiske kompenserende mekanismer.
English: Interactions requiring precautions for use
Danish: Interaktioner, der kræver forsigtighedsregler vedrørende brugen
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: 9 DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Concomitant use may reduce the reflex sympathetic response involved when excessive distal vasodilatation.
Danish: Samtidig brug kan reducere den refleksive sympatiske respons i tilfælde af overdreven distal vasodilatation.
English: The MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority prior to distribution of the educational pack.
Danish: Indehaveren af markedsføringstilladelsen vedtager uddannelsesmaterialets indhold og format samt en kommunikationsplan sammen med de kompetente nationale myndigheder, før distribution af uddannelsespakken.
English: This combination must only be administered under close clinical and ECG monitoring, particularly at the start of the treatment.
Danish: Denne kombination må kun administreres under tæt klinisk overvågning og EKG monitorering, især i starten af behandlingen.
English: Diarrhea was frequently reported and was not always associated with an infectious gastrointestinal disease.
Danish: Der blev jævnligt rapporteret om diarré, som ikke altid kunne forbindes med en smitsom gastrointestinal sygdom.
English: • an apoptosis-triggering effect on capillary endothelial cells;
Danish: • en apoptose-udløsende virkning på kapillære endotelceller;
English: The volume of distribution of propranolol is approximately 4 L/kg.
Danish: Distributionsvolumenet af propranolol er ca. 4 L/kg.
English: Date of first authorisation: 23 April 2014 Date of latest renewal:
Danish: Dato for første tilladelse: 23 april 2014.
English: Instructions for use: • Step 1.
Danish: Brugsanvisning: • Trin 1.
English: If different people are involved, good communication is essential in order to ensure the safety of the child.
Danish: Hvis flere personer involveres, er god kommunikation afgørende for at sørge for barnets sikkerhed.
English: Infections and infestations
Danish: Infektion og infestation
English: Peak plasma concentrations occur about 1 to 4 hours after an oral dose.
Danish: Peak-plasmakoncentrationer forekommer omkring 1 til 4 timer efter en oral dosis.
English: • Very low levels of white blood cells that fight infection
Danish: • Meget lavt antal hvide blodlegemer, som bekæmper infektion,
English: However, studies suggest that P-gp is not dose-limiting for intestinal absorption of propranolol in the usual therapeutic dose range.
Danish: Studier lader dog formode, at P-gp ikke er dosisbegrænsende for intestinal absorption af propranolol i det sædvanlige terapeutiske dosisinterval.
English: • Urticaria (allergic reaction of the skin), alopecia (loss of hair),
Danish: • Urticaria (allergisk reaktion på huden), alopeci (hårtab),
English: 4 CLINICAL PARTICULARS 4.1 Therapeutic indications
Danish: 4 KLINISKE OPLYSNINGER 4.1 Terapeutiske indikationer
English: However, it undergoes an extensive first-pass metabolism by the liver and on average only about 25% of propranolol reaches the systemic circulation.
Danish: Det undergår dog en omfattende førstepassage-metabolisme via leveren og gennemsnitligt når kun omkring 25 % propranolol den systemiske cirkulation.
English: The readministration of propranolol may be considered when the child has fully recovered; in case of reoccurrence, treatment should be permanently discontinued.
Danish: En genoptagelse af administration af propranolol kan overvejes, når barnet er helt rask; i tilfælde af tilbagefald, skal behandlingen afbrydes permanent.
English: Only use the oral syringe that is supplied with the medicine to measure and administer the dose.
Danish: Brug kun den orale sprøjte der følger med medicinen til at afmåle og administrere dosen.
English: Every increase in dose or any dose adjustment to your baby's weight must be done by your doctor.
Danish: Enhver forøgelse af dosis eller justering efter dit barns vægt skal udføres af lægen.
English: In the minority of patients showing a relapse of symptoms after treatment discontinuation, treatment may be re-initiated under the same conditions with a satisfactory response.
Danish: Hos det fåtal af patienter, der viser tilbagefaldssymptomer efter behandlingens ophør, kan behandlingen genoptages på samme vilkår med en tilfredsstillende respons.
English: Within each system organ class, adverse reactions are presented in order of decreasing seriousness.
Danish: Indenfor hvert organklassesystem præsenteres bivirkninger i faldende orden i forhold til graden af alvor.
English: Concomitant use can increase the risk of bradycardia.
Danish: Samtidig brug kan øge risikoen for bradykardi.
English: • Premature infants, for whom the corrected age of 5 weeks has not been reached (the corrected age being calculated by subtracting the number of weeks of prematurity from the actual age)
Danish: • For tidligt fødte børn, for hvem den korrigerede alder på 5 uger ikke er nået (den korrigerede alder udregnes ved at fratrække antallet af for tidligt fødte uger fra den faktiske alder)
English: This is why your child will be kept under close clinical and heart rate monitoring for 2 hours after the first dose or after a dose increase.
Danish: Derfor skal dit barn derfor holdes under tæt klinisk overvågning og hjertemonitorering i 2 timer efter den første dosis og efter en forøgelse af dosen.
English: • a reduction of both VEGF and bFGF signalling pathways and subsequent angiogenesis /
Danish: • et fald i både VEGF og bFGF signaleringsveje og efterfølgende angiogenese / proliferation.
English: EXP After first opening, the medicine should be used within 2 months.
Danish: EXP Efter første åbning bør lægemidlet anvendes inden for 2 måneder.
English: Similar results were obtained following intra-testicular administration of propranolol and using in vitro models.
Danish: Lignende resultater blev opnået efter intratestikulær administration af propranolol og ved brug af in vitro modeller.
English: Concommitant use not recommended
Danish: Samtidig brug anbefales ikke
English: Locate this number on the oral syringe.
Danish: Find dette tal på den orale sprøjte.
English: • Reduction of the number of white blood cells.
Danish: • Reduktion af antallet af hvide blodlegemer.
English: To avoid risks of hypoglycaemia, your child must be fed regularly during treatment.
Danish: For at undgå risiko for hypoglykæmi, skal dit barn mades jævnligt under behandlingen.
English: Administration of protein-rich foods increases the bioavailability of propranolol by about 50% with no change in time to peak concentration.
Danish: Administration af proteinrige fødevarer øger biotilgængeligheden for propranolol med omkring 50 % uden ændringer i tiden for peak-koncentration.
English: Do not use any other measuring device.
Danish: Brug ikke andre måleredskaber.
English: Box of 1 bottle.
Danish: Æske med 1 flaske.
English: In children with diabetes, blood glucose monitoring should be more frequent and followed by the endocrinologist.
Danish: Hos børn med diabetes skal blodsukkeret monitoreres hyppigere og følges af endokrinologen.
English: Check the dose
Danish: Kontrollér dosis
English: The plasma half-life of propranolol ranges from 3 to 6 hours.
Danish: Plasmaens halveringstid for propranolol spænder fra 3 til 6 timer.
English: • Medicines to treat anxiety and depression as well as more serious mental health problems, and epilepsy,
Danish: • Medicin, der behandler angst og depression, såvel som mere alvorlige mentale problemer og epilepsi,
English: • If your child has ever had an allergic reaction whatever its origin (e.g. medicine or alimentary substance etc.).
Danish: • Hvis dit barn nogensinde har haft en allergisk reaktion, uanset hvad årsagen var (f.eks. et lægemiddel eller en fødevare).
English: After the titration phase, the dose will be readjusted by the physician according to the changes in the child's weight.
Danish: Efter titreringsfasen justeres dosen af lægen i overensstemmelse med ændringer i barnets vægt.
English: With regard to centrally-acting antihypertensives, betablockers may exacerbate the rebound hypertension after clonidine abrupt withdrawal, and propranolol should be stopped several days before discontinuing clonidine.
Danish: Hvad angår centralt virkende antihypertensiva, kan betablokkere forværre hypertension efter brat tilbagetrækning af clonidin, og propranolol bør standses flere dage før afbrydelsen af clonidin.
English: Prior to initiating propranolol therapy, screening for risks associated with propranolol use must be performed.
Danish: Før igangsættelse af propranololbehandling, skal der gennemføres en screening for risici forbundet med brug af propranolol.
English: Although some data were equivocal, based on the overall available in vitro and in vivo data, it can be concluded that propranolol is devoid of genotoxic potential.
Danish: Selvom visse data var tvetydige, kan det på baggrund af de overordnede tilgængelige in vitro og in vivo data konkluderes, at propranolol er blottet for genotoksisk potentiale.
English: Treatment success was defined as a complete or nearly complete resolution of the target haemangioma, which was evaluated by blinded centralized independent assessments made on photographs at Week 24, in the absence of premature treatment discontinuation.
Danish: Behandlingssuccesen blev defineret som en komplet, eller næsten komplet remission af målhæmangiomet, som blev evalueret af en blændet centraliseret uafhængig vurdering foretaget på fotografier ved uge 24, hvis der ikke var indtruffet en for tidlig afbrydelse af behandlingen.
English: These effects rarely led to definitive treatment discontinuation (see section 4.4).
Danish: Disse effekter førte sjældent til endelig afbrydelse af behandlingen (se pkt.
English: Improvement of haemangioma was observed at 5 weeks of treatment by propranolol in 88% of patients.
Danish: Der blev observeret en forbedring af hæmangiom efter 5 ugers behandling med propranolol hos 88 % af patienterne.
English: • is born prematurely and he/she has not reached the corrected age of 5 weeks (the corrected age being the age a premature baby would be if he/she had been born on their due date).
Danish: • er født for tidligt, og han/hun ikke har nået den korrigerede alder på 5 uger (den korrigerede alder er den alder, som en for tidligt født baby ville have, hvis han/hun var født til terminen).
English: Pharmacotherapeutic group: Beta-Blocking agent, non-selective, ATC code: C07AA05
Danish: Farmakoterapeutisk klassifikation: Betablokerende stof, non-selektiv, ATC-kode: C07AA05
English: The 4-hydroxy-propranolol metabolite was quantified, its plasma exposure accounting for less than 7% of the parent drug exposure.
Danish: 4-hydroxy-propranolol metabolitten blev kvantificeret, dens plasmaeksponering udgjorde mindre end 7 % af moderstoffets eksponering.
English: Isoproterenol and aminophylline may be used for bronchospasm.
Danish: Isoproterenol og aminofyllin kan anvendes ved bronchospasme.
English: In the absence of specific studies in children, the drug interactions with propranolol are those known in adults.
Danish: Da der ikke foreligger specifikke studier hos børn, er lægemiddelinteraktioner med propranolol dem, som kendes fra voksne.
English: Absorption and distribution:
Danish: Voksne Absorption og distribution:
English: 6-12 months
Danish: 6-12 måneder
English: HEMANGIOL may be stopped at once at the end of the treatment as decided by the doctor.
Danish: HEMANGIOL kan ophøre umidelbart ved behandlingens afslutning i henhold til lægens anvisning.
English: Please refer to section 2 of this leaflet.
Danish: Se punkt 2 i denne indlægsseddel.
English: Do not use this medicine after the expiry date which is stated on the outer carton and bottle label.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og flaskeetiketten.
English: Now you can slowly squirt HEMANGIOL from the syringe directly into your baby's mouth.
Danish: Nu kan du langsomt sprøjte HEMANGIOL fra sprøjten direkte i barnets mund.
English: Mortality with unknown although unlikely relationship to treatment was observed at 40 mg/kg/day, leading to a NOAEL of 20 mg/kg/day for juvenile toxicity.
Danish: En dødelighed med ukendt skønt usandsynlig forbindelse til behandlingen blev observeret ved 40 mg/kg/dag, hvilket fører til en NOAEL på 20 mg/kg/dag for juvenil toksicitet.
English: The toxicity of beta-blockers is an extension of their therapeutic effects:
Danish: Toksiciteten i betablokkere er en forlængelse af deres terapeutiske effekter:
English: Propranolol was rapidly absorbed, the maximum plasma concentration generally occurring 2 hours after administration with a corresponding mean value around 79 ng/mL whatever the infant age.
Danish: Propranolol blev hurtigt absorberet, idet den maksimale plasmakoncentration som regel opstod 2 timer efter administration, med en tilsvarende middelværdi omkring 79 ng/ml uanset spædbarnets alder.
English: The administration of beta2 agonists and inhaled corticosteroids is possible.
Danish: Det er muligt at administrere beta2 agonister og indhalerede kortikosteroider.
English: Open the bottle
Danish: Åben flasken
English: • Bradycardia below the following limits:
Danish: • Bradykardi under følgende grænser:
English: The bottle should not be shaken before use.
Danish: Flasken bør ikke omrystes før brug.
English: • If your child has problems with his/her liver or kidneys.
Danish: • Hvis dit barn har problemer med lever eller nyrer.
English: A haemangioma is a collection of extra blood vessels that have formed a lump in or under the skin.
Danish: Et hæmangion er en ansamling af ekstra blodkar, som har dannet en knude i eller under huden.
English: Close the bottle.
Danish: Luk flasken.
English: Glucagon then catecholamines should be considered if the patient does not respond appropriately to intravenous fluid.
Danish: Glukagon og derefter katekolaminer bør overvejes, hvis patienten ikke responderer tilstrækkeligt på den intravenøse væske.
English: • Decreased appetite,
Danish: • Nedsat appetit,
English: The potential effects of propranolol on the development of juvenile rats were evaluated following daily oral administration from post-natal Day 4 (PND 4) to PND 21 at dose-levels of 0, 10, 20 or 40 mg/kg/day.
Danish: Den potentielle effekt af propranolol på unge rotters udvikling er blevet evalueret efter en daglig oral administration fra postnatal Dag 4 (PND 4) til PND 21 ved et dosisniveau på 0, 10, 20 eller 40 mg/kg/dag.
English: In vitro studies indicated that CYP2D6 (aromatic hydroxylation), CYP1A2 (chain oxidation) and to a less extent CYP2C19 were involved in propranolol metabolism.
Danish: In vitro studier indikerer, at CYP2D6 (aromatisk hydroxylation), CYP1A2 (kædeoxidation) og i mindre grad CYP2C19 var involveret i propranolol metabolisme.
English: Cardiovascular events reported during clinical studies were asymptomatic.
Danish: Rapporterede kardiovaskulære hændelser under kliniske studier var asymptomatiske.
English: HEMANGIOL might need to be discontinued at least 48h before the anaesthesia.
Danish: Behandlingen med HEMANGIOL skal måske standses mindst 48 timer før anæstesien.
English: Warnings and precautions Before your child receives HEMANGIOL, tell your doctor:
Danish: Advarsler og forsigtighedsregler Før dit barn får HEMANGIOL, tal med lægen:
English: Do not put the syringe through a sterilizer or dishwasher.
Danish: Kør ikke sprøjten gennem en steriliserings- eller opvaskemaskine.
English: Treatment with propranolol resulted in a rapid improvement (within 7-14 days) in all patients and resolution of the target haemangioma was observed in 36.4% of patients by 3 months.
Danish: Behandling med propranolol resulterede i en hurtig forbedring (i løbet af 7-14 dage) hos alle patienter, og en remission af målhæmangiom blev observeret hos 36,4 % af patienterne efter 3 måneder.
English: 1 NAME OF THE MEDICINAL PRODUCT
Danish: 1 LÆGEMIDLETS NAVN