FrancophonIA/ELRC3.0 huggingface dataset:
English: These hypoglycaemic episodes associated with the taking of propranolol may present exceptionally in the form of seizures and/or coma.
Danish: Disse hypoglykæmiske episoder kombineret med indtagelse af propranolol kan undtagelsesvist vise sig i form af krampeanfald og/eller koma.
English: This educational pack is aimed at increasing awareness about the potential risk of hypotension, bradycardia, and bronchospasm, after taking HEMANGIOL, and providing guidance on how to monitor/manage that risk.
Danish: Denne undervisningspakke har til hensigt at øge bevidstheden om den potentielle risiko for hypotension, bradykardi og bronchospasme efter indtagelse af HEMANGIOL og give vejledning om, hvordan denne risiko skal monitereres/håndteres.
English: In animals, after an acute dosing, propranolol is considered as a moderately toxic drug with an oral LD50 of about 600 mg/kg.
Danish: Hos dyr, efter en akut dosis, betragtes propranolol som et moderat toksisk præparat med en oral LD50 på omkring 600 mg/kg.
English: • This medicine has been prescribed for your child only.
Danish: • Lægen har ordineret dette lægemiddel til dit barn personligt.
English: Digitalis glycosides
Danish: Digitalis Glycosid
English: Potential mechanisms of action of propranolol in proliferating infantile haemangioma described in the literature could include various mechanisms all in close relationship:
Danish: Virkningsmekanisme Potentielle virkningsmekanismer for propranolol i prolifererende infantil hæmangiom beskrevet i litteraturen kunne omfatte forskellige mekanismer, som alle er tæt forbundet med hinanden:
English: A close clinical surveillance of any impaired tolerance of propranolol is requested.
Danish: En tæt klinisk overvågning af enhver svækket tolerance over for propranolol er påkrævet.
English: If your child should undergo a general anaesthesia
Danish: Hvis dit barn skal gennemgå en generel anæstesi
English: Patients (71.3% female; 37% aged 35-90 days old and 63% aged 91-150 days old) presented a target haemangioma on the head in 70% and majority of the infantile haemangiomas were localized (89%).
Danish: Patienterne (71,3 % piger; 37 % i alderen 35-90 dage gamle og 63 % i alderen 91-150 dage gamle) havde et mål-hæmangiom i hovedet i 70 % af tilfældene og størstedelen af de infantile hæmangiomer var lokaliserede (89 %).
English: None of cases was of severe intensity and led to treatment discontinuation.
Danish: Ingen af tilfældene var af alvorlig karakter eller førte til afbrydelse af behandlingen.
English: After the first intake and each dose increase, a clinical monitoring, including blood pressure and heart rate must be performed at least hourly for at least 2 hours.
Danish: Efter første indtagelse og ved hver forøgelse af dosis, skal der foretages en klinisk monitorering, inklusiv blodtryk og hjertefrekvens mindst en gang i timen i mindst to timer.
English: • Medicines used to lower lipids in the blood,
Danish: • Medicin til sænkning af lipider i blodet,
English: In children with cardiac failure, the treatment should be managed by the cardiologist.
Danish: Hos børn med hjerteinsufficiens bør behandlingen forestås af kardiologen.
English: 0-3 months
Danish: 0-3 måneder
English: • Moreover, if you are breastfeeding your child, it is important to tell your doctor, pharmacist or nurse which medicines you are yourself taking, as they may pass into your breast-milk and interfere with the treatment of your child.
Danish: • Derudover er det vigtigt, hvis du ammer dit barn, at fortælle det til lægen eller på apoteket hvilken anden medicin, du selv tager, da den kan passere over i din brystmælk og forstyrre behandlingen af dit barn.
English: Once corrected by the body weight, primary pharmacokinetic parameters for propranolol (such as plasma clearance) determined in infants were similar to those reported in the literature for adults.
Danish: Efter korrektion for kropsvægt var de primære farmakokinetiske parametre for propranolol (såsom plasma-clearance) bestemt for spædbørn lignende dem, der er rapporteret om i litteraturen for voksne.
English: • Cardiac symptoms of mild to moderate poisoning are decreased heart rate and hypotension.
Danish: • Hjerterelaterede symptomer på mild til moderat forgiftning er nedsat hjertefrekvens og hypotension.
English: HEMANGIOL is indicated in the treatment of proliferating infantile haemangioma requiring systemic therapy:
Danish: HEMANGIOL er indiceret til behandling af prolifererende infantil hæmangiom, som kræver systemisk behandling:
English: After first opening, the medicine should be used within 2 months.
Danish: Efter første åbning, skal lægemidlet anvendes inden for 2 måneder.
English: Insert the syringe into your baby's mouth and place it against the inside of the cheek.
Danish: Før sprøjten ind i barnets mund, og placér den mod indersiden af kinden.
English: Clinical monitoring of the child condition, and dose readjustment, need to be performed at least monthly.
Danish: Der skal udføres klinisk overvågning af barnets tilstand og justering af dosis mindst hver måned.
English: • Severe peripheral arterial circulatory disturbances (Raynaud's phenomenon)
Danish: • Alvorlige perifere kredsløbsforstyrrelser (Raynauds syndrom)
English: If you see air bubbles in the syringe, hold the syringe upright, push the plunger upwards just far enough to completely push out any large air bubbles and then readjust to the dose prescribed by your doctor.
Danish: Hvis du observerer luftbobler i sprøjten, hold sprøjten oprejst, tryk stemplet så meget opad som muligt for at fjerne alle store luftbobler helt, og justér derefter dosis i forhold til det, din læge har ordineret.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Detaljeret information om dette medicinalprodukt er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Wipe the outside dry.
Danish: Tør ydersiden af.
English: • Ulcerated haemangioma with pain and/or lack of response to simple wound care measures,
Danish: • Ulcereret hæmangiom med smerter og/eller manglende reaktion på enkle sårplejetiltag,
English: The regimen 3 mg/kg/day during 6 months (selected at the end of the phase II part of the study) presented 60.4% of success versus 3.6% in the placebo arm (p value < 0.0001).
Danish: Behandlingsregimet med 3 mg/kg/dag over 6 måneder (udvalgt i slutningen af studiets fase II) svarede til 60,4 % succes mod 3,6 % i placeboarmen (p værdi < 0,0001).
English: • Breastfed infants, if the mother is treated with medicinal products contraindicated with propranolol
Danish: • Børn som ammes, hvis moderen behandles med lægemidler kontraindiceret med propranolol
English: Both agents may induce hypotension and/or heart failure in patients whose cardiac function is partially controlled because of additive inotropic effects.
Danish: Begge stoffer kan fremkalde hypotension og/eller hjerteinsufficiens hos patienter med en hjertefunktion, der er delvist er kontrolleret på grund af en forstærkende inotrop virkning.
English: In case of symptomatic bradycardia or bradycardia under 80 bpm, immediate specialist advice must be sought.
Danish: I tilfælde af symptomatisk bradykardi eller bradykardi under 80 slag/min, skal der øjeblikkeligt søges råd hos en specialist.
English: • Medicines to treat pain and inflammation,
Danish: • Medicin, der behandler smerter og inflammation,
English: This medicine is used to treat a disease called haemangioma.
Danish: Dette lægemiddel anvendes til behandling af en sygdom kaldet hæmangiom.
English: In case of suspected cardiac abnormality, a specialist advice must be sought before treatment initiation to determine any subjacent contra-indication.
Danish: Hvis der er mistanke om hjerteanomali, skal en specialist rådspørges før iværksættelse af behandling, for at bestemme en mulig underliggende kontraindikation.
English: The active ingredient is propranolol.
Danish: Den aktive ingrediens er propranolol.
English: When a patient is scheduled for surgery, beta-blocker therapy should be discontinued at least 48 hours prior to the procedure.
Danish: Når en patient skal gennemgå en planlagt operation, skal behandlingen med betablokkere afbrydes i mindst 48 timer forud for operationen.
English: • Low blood pressure below the following limits:
Danish: • Lavt blodtryk under følgende grænser:
English: Intravenous fluids for hypotension and atropine for bradycardia should be given.
Danish: Der bør gives intravenøs væske for hypotension og atropin for bradykardi.
English: Blood sugar decreases observed during clinical studies were asymptomatic.
Danish: Blodsukkerfald observeret under kliniske studier var asymptomatiske.
English: Propranolol is a substrate for the intestinal efflux transporter, P-glycoprotein (P-gp).
Danish: Propranolol er et substrat for den intestinale effluxtransportør, P-glycoprotein (P-gp).
English: Metabolism and nutrition disorders
Danish: Metabolisme og ernæringslidelser
English: • Agitation, nightmares, irritability,
Danish: • Ophidselse, mareridt, pirrelighed,
English: Treatment was administered to 456 subjects (401 Propranolol at a dose of 1 or 3 mg/kg/day for 3 or 6 months; 55 Placebo), including a titration phase over 3 weeks.
Danish: Behandlingen blev administreret til 456 personer (401 propranolol ved en dosis på 1 eller 3 mg/kg/dag i 3 eller 6 måneder; 55 placebo), som omfattede en titreringsfase på 3 uger.
English: Concomitant treatment with systemic corticosteroids may increase the risk of hypoglycemia (see section 4.5).
Danish: Samtidig behandling med systemiske kortikosteroider kan forhøje risikoen for hypoglykæmi (se pkt.
English: • Tell your doctor, pharmacist or nurse if you are giving, have recently given or might give any other medicines to your child.
Danish: • Fortæl det altid til lægen eller på apoteket, hvis du giver, eller for nylig har givet eller måske vil give dit barn anden medicin.
English: Approximately 90% of circulating propranolol is bound to plasma proteins (albumin and alpha1 acid glycoprotein).
Danish: Omkring 90 % af cirkulerende propranolol er bundet til plasmaproteiner (albumin og alfa1-syreglykoprotein).
English: • If your child spits up a dose or if you are uncertain whether he/she got all of the medicine, do not give another dose, just wait until the next scheduled dose.
Danish: • Hvis dit barn gylper en dosis op, eller hvis du er usikker på om han/hun har fået al medicinen, så giv ikke endnu en dosis, men vent til den næste planlagte dosis.
English: These effects were completely reversible when treatment was discontinued.
Danish: Disse effekter var fuldstændig reversible efter afbrydelse af behandlingen.
English: It is to be initiated in infants aged 5 weeks to 5 months (see section 4.2).
Danish: Behandlingen skal initieres hos spædbørn i alderen 5 uger til 5 måneder (se pkt.
English: During the titration phase, each dose increase must be managed and monitored by a physician in the same conditions as the administration of the initial dose.
Danish: Hver forøgelse af dosen under titreringsfasen skal administreres og overvåges under lægeligt tilsyn under samme forhold som administrationen af den første dosis.
English: Specialised advice should be sought.
Danish: Der bør indhentes råd fra en specialist.
English: • Step 10: Clean the syringe.
Danish: • Trin 10: Rengør sprøjten.
English: The recommended starting dose is 1 mg/kg/day which is divided into two separate doses of 0.5 mg/kg.
Danish: Den anbefalede startdosis er 1 mg/kg/dag, som deles i to separate doser på 0,5 mg/kg.
English: If you are breastfeeding your child, and if you are taking medicines that must not be used with HEMANGIOL (see ‘‘If you are breastfeeding your child'' and “Other medicines and HEMANGIOL”) do not give this medicine to your child.
Danish: Hvis du ammer dit barn, og hvis du tager lægemidler, der ikke må anvendes sammen med HEMANGIOL (se ‘‘Hvis du ammer dit barn'' og “Brug af anden medicin sammen med HEMANGIOL”), må du ikke give dette lægemiddel til dit barn.
English: Co-administration of cholestyramine or colestipol with propranolol resulted in up to 50% decrease in propranolol concentrations.
Danish: Administration af cholestyramin eller colestipol sammen med propranolol har resulteret i et fald på op til 50 % af propranolol-koncentrationen.
English: 5 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Danish: 5 FARMAKOLOGISKE EGENSKABER 5.1 Farmakodynamiske egenskaber
English: 3-6 months
Danish: 3-6 måneder
English: Sleep disorders corresponded to insomnia, poor quality of sleep and hypersomnia.
Danish: Søvnforstyrrelser svarede til søvnløshed, dårlig søvnkvalitet og hypersomni.
English: Do not shake the bottle before use.
Danish: Omryst ikke flasken før brug.
English: • Purified water
Danish: • Destilleret vand
English: The name of your medicine is HEMANGIOL.
Danish: Lægemidlets navn er HEMANGIOL.
English: This medicine will not be recommended in case of liver or kidneys impairment.
Danish: Dette lægemiddel vil ikke blive anbefalet i tilfælde af nedsat lever- eller nyrefunktion.
English: One case of second degree atrioventricular heart block in a patient with underlying conduction disorder led to definitive treatment discontinuation.
Danish: Et tilfælde af andengrads atrioventrikulær hjerteblok hos en patient med underliggende ledningslidelse har ført til en definitiv afbrydelse af behandlingen.
English: Pack size: carton containing 1 bottle and 1 oral syringe.
Danish: Pakningsstørrelse: æske indeholdende 1 flaske og 1 oral sprøjte.
English: • Sleep disorders (insomnia, poor quality of sleep and difficulties to wake-up),
Danish: • Søvnforstyrrelser (søvnløshed, dårlig søvnkvalitet og svært ved at vågne),
English: If you are breastfeeding your child
Danish: Hvis du ammer dit barn
English: It can aggravate hypoglycaemia in children, especially in case of fasting, vomiting or overdose.
Danish: Det kan forværre hypoglykæmi hos børn, især i tilfælde af faste, opkast eller overdosering.
English: The medicine should not be put in the full filled bottle.
Danish: Medicinen bør ikke hældes i den helt fyldte sutteflaske.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTLIGÆNGELIGT FOR BØRN
English: In terms of reproductive development, growth and neurological development there were no propranolol-related effects or toxicologically significant findings at 40 mg/kg/day, correlating to safety margins of 1.2 in females and 2.9 in males, based on mean propranolol exposures on PND 21.
Danish: Hvad angår reproduktiv udvikling, vækst og neurologisk udvikling var der ingen propranololrelaterede effekter eller toksikologisk signifikante fund ved 40 mg/kg/dag, hvilket svarer til sikkerhedsmargener på 1,2 for hunrotter og 2,9 for hanrotter på basis af en gennemsnitlig propranolol eksponering på PND 21.
English: • Medicines for diabetes,
Danish: • Medicin for diabetes,
English: In case of large ulcerated haemangioma,, your child's blood potassium level should be measured.
Danish: I tilfælde af et stort ulcereret hæmangiom skal dit barns kaliumniveau i blodet måles.
English: The occurrence of diarrhea seems to be dose-dependent between 1 and 3 mg/kg/day.
Danish: Forekomsten af diarré synes at være dosisafhængig mellem 1 og 3 mg/kg/dag.
English: In dietary administration studies in which mice and rats were treated with propranolol hydrochloride for up to 18 months at doses of up to 150 mg/kg/day, there was no evidence of drug-related tumorigenesis.
Danish: I studier med administration via kosten, hvor mus og rotter blev behandlet med propranolol hydroklorid i op til 18 måneder med doser på op til 150 mg/kg/dag, var der intet bevis på stofrelateret tumorigenese.
English: The treatment of your child has been initiated by a physician who has expertise in the diagnosis, treatment and management of infantile haemangioma.
Danish: Dit barns behandling er blevet startet af en læge, der har erfaring med at stille diagnose, behandle og varetage infantil hæmangiom.
English: Non-cardiovascular medicinal products
Danish: Non-kardiovaskulære lægemidler
English: • If your child has psoriasis (a skin condition that produces red, dry plaques of thickened skin), as this medicine may worsen the symptoms of this condition.
Danish: • Hvis dit barn har psoriases (en hudlidelse, der giver røde, tørre pletter af fortykket hud), da dette lægemiddel kan forværre symptomerne på denne tilstand.
English: 1 bottle of 120 mL and 1 oral syringe.
Danish: 1 flaske à 120 ml og 1 oral sprøjte.
English: • The active substance is propranolol.
Danish: • Det aktive stof er propranolol.
English: • has asthma or history of breathing difficulties.
Danish: • har astma eller en sygehistorie med åndedrætsbesvær.
English: Caution should be taken into account in babies less than 4 weeks old, in particular if the baby is given other medicines that contain propylene glycol or alcohol.
Danish: Der skal udvises forsigtighed hos spædbørn under 4 uger, især hvis spædbarnet får andre lægemidler, der indeholder propylenglycol eller alkohol.
English: Propranolol is a beta-blocker that is characterised by three pharmacological properties:
Danish: Propranolol er en betablokker der karakteriseres af tre farmakologiske egenskaber:
English: It is also aimed to instruct caregivers to correctly feed the children during treatment in order to avoid the risk of hypoglycaemia.
Danish: Den har ligeledes til hensigt at instruere plejepersonalet om, hvordan de skal give barnet mad under behandlingen for at undgå risikoen for hypoglykæmi.
English: • Cardiogenic shock
Danish: • Kardiogent shock
English: Hemangiol is started in infants aged 5 weeks to 5 months, when: - the localisation and/or extend of the lesions are life- or function threatening (might impair vital organs or senses such as vision or hearing); - the haemangioma is ulcerated (i.e. with sore on the skin which fails to heal) and painful, and/or does not respond to simple wound care measures; - there is a risk of permanent scars or disfigurement.
Danish: Hemangiol startes hos spædbørn i alderen 5 uger til 5 måneder, når: - lokaliseringen og / eller læsionerne er livs- eller funktionstruende (kan svække vitale organer eller sanser, såsom syn eller hørelse); - hæmangiomet er sårdannende (dvs. med sår i huden, som ikke heler) og smertefuldt og / eller ikke reagerer på enkel sårplejebehandling; - når der er risiko for varige ar eller vansiring.
English: Mean apparent oral clearance was 2.71 L/h/kg in infants aged 65- 120 days and 3.27 L/h/kg in infant aged 181- 240 days.
Danish: Middel oral clearance var 2,71 l/t/kg hos børn i alderen 65- 120 dage og 3,27 l/t/kg hos spædbørn i alderen 181- 240 dage.
English: Evidence of the efficacy of propranolol in patients with highrisk haemangioma is available both in literature and in a specific compassionate use program performed with Hemangiol.
Danish: Beviset på virkningen af propranolol hos patienter med højrisiko hæmangiom er tilgængeligt både i litteraturen og i specifikke programmer for anvendelse med særlig udleveringstilladelse med Hemangiol.
English: • has a heart problem (such as disorders of the heart rhythm and heart failure.
Danish: • har et hjerteproblem (såsom forstyrrelser i hjerterytme og hjertesvigt).
English: Propranolol is metabolized through three primary routes: aromatic hydroxylation (mainly 4hydroxylation), N-dealkylation followed by further side-chain oxidation, and direct glucuronidation.
Danish: Propranolol metaboliseres gennem tre primære ruter: aromatisk hydroxylation (hovedsagelig 4hydroxylation), N-dealkylation efterfulgt af yderligere sidekæde-oxidation og direkte glukuronidation.
English: It is recommended to increase the dose up to the therapeutic dose under medical supervision as follows: 1 mg/kg/day for 1 week, then 2 mg/kg/day for 1 week and then 3 mg/kg/day as a maintenance dose.
Danish: Det anbefales at øge dosis til den terapeutiske dosis under medicinsk overvågning som følger: 1 mg/kg/dag i 1 uge, derefter 2 mg/kg/dag i 1 uge og derefter 3 mg/kg/dag som vedligeholdelsesdosis.
English: In this case, inform the caregiver, and increase monitoring of blood glucose levels, particularly at the start of treatment.
Danish: I sådanne tilfælde skal plejepersonalet informeres og monitoreringen af blodsukkerniveauet øges, især i starten af behandlingen.
English: HEMANGIOL contains sodium and propylene glycol
Danish: HEMANGIOL indeholder natrium og propylenglycol
English: • Decreased blood sugar levels,
Danish: • Nedsat blodsukkerniveau,
English: 3- Discard the water into your sink
Danish: 3- Hæld vandet ud i vasken
English: Blood levels of propranolol may be decreased by co-administration of enzyme inducers like rifampicin or phenobarbital.
Danish: Blodets indhold af propranolol kan nedsættes ved samtidig administration af enzyminduktorer, såsom rifampicin eller phenobarbital.
English: • has a high blood pressure caused by a tumour on the adrenal gland.
Danish: • har et højt blodtryk på grund af en tumor på binyren.
English: In the context of the 4 hours cardiovascular monitoring during the titration days, it was observed a decrease of heart rate (about 7 bpm) and of systolic blood pressure (less than 3 mmHg) following drug administration.
Danish: I forbindelse med de 4 timers kardiovaskulær monitorering i løbet af titreringsdagene, blev der observeret et fald i hjertefrekvens (omkring 7 slag/min) og af systolisk blodtryk (mindre end 3 mmHg) efter administration af præparatet.
English: Here is how to open it: push down the plastic cap while turning the cap counter-clockwise (to the left).
Danish: Sådan åbnes den: Tryk ned på plastiklåget, mens du drejer det mod uret (mod venstre).
English: The patient should be placed on a cardiac monitor, monitor vital signs, mental status and blood glucose.
Danish: Patienten bør kobles til en hjertemonitor, vitale tegn, mental status og blodsukker bør monitoreres.
English: • Give HEMANGIOL directly into your child's mouth using the oral syringe supplied with the bottle.
Danish: • Giv HEMANGIOL direkte i barnets mund ved hjælp af den orale sprøjte, der leveres sammen med flasken.
English: The pharmacokinetics of repeated administrations of HEMANGIOL at 3 mg/kg/day given in 2 intakes has been investigated in 19 infants aged 35 to 150 days at the beginning of treatment.
Danish: Farmakokinetikken ved gentagne administrationer af HEMANGIOL med 3 mg/kg/dag givet i 2 indtag er blevet undersøgt hos 19 børn i alderen 35 til 150 dage i behandlingens start.
English: This medicine can mask the warning signs of hypoglycaemia (also known as low blood sugar level), especially if the baby is fasting, vomiting or in case of overdose.
Danish: Dette lægemiddel kan maskere advarselssignalerne for hypoglykæmi (også kaldet lavt blodsukkerniveau), især hvis babyen faster, kaster op eller i tilfælde af overdosering.
English: Use the mixture within 2 hours of preparation.
Danish: Brug blandingen senest 2 timer efter klargøring.
English: If clinical signs of hypoglycaemia occur, it is necessary to make the child drink a sugary liquid solution and to temporarily stop the treatment.
Danish: Hvis der opstår kliniske tegn på hypoglykæmi, er det nødvendigt at få barnet til at drikke en sukkerholdig opløsning og afbryde behandlingen midlertidigt.
English: Clinical efficacy and safety in the paediatric population The efficacy of propranolol in infants (aged 5 weeks to 5 months at treatment initiation) with proliferating infantile haemangioma requiring systemic therapy has been demonstrated in a pivotal randomised, controlled, multicentre, multidose, adaptive phase II/III study aimed to compare four regimens of propranolol (1 or 3 mg/kg/day for 3 or 6 months) to placebo (double blind).
Danish: Klinisk virkning og sikkerhed i den pædiatriske population Effektiviteten af propranolol hos spædbørn (i alderen 5 uger til 5 måneder ved behandlingens start) med prolifererende infantil hæmangiom, som påkræver systemisk behandling, er demonstreret i et randomiseret, kontrolleret, multicenter, multidosis, adaptiv fase II/III studie i den hensigt at sammenligne fire kure med propranolol (1 eller 3 mg/kg/dag i 3 eller 6 måneder) mod placebo (dobbelt blind).