FrancophonIA/ELRC3.0 huggingface dataset:
English: In healthy subjects, no difference was observed between CYP2D6 extensive metabolizers and poor metabolizers with respect to oral clearance or elimination half-life.
Danish: Hos sunde personer blev der ikke observeret forskelle mellem hurtige og langsomme CYP2D6omsættere, hvad angår oral clearance eller halveringstid ved eliminering.
English: • infants breastfed by mothers taking any other medicinal products, notably those mentioned below.
Danish: • børn der ammes af mødre, som indtager andre lægemidler, især dem nævnt nedenfor.
English: If your child gets any side effects, talk to your doctor or pharmacist.
Danish: Hvis dit barn får bivirkninger, bør du tale med din læge eller apoteket.
English: In case of severe and/or symptomatic bradycardia or hypotension occurring at any time during treatment, treatment must be discontinued and a specialist advice should be sought.
Danish: Hvis der opstår alvorlig og/eller symptomatisk bradykardi eller hypotension på et vilkårligt tidspunkt under behandlingen, skal behandlingen afbrydes, og en specialist skal rådspørges.
English: An analysis of the medical history and a full clinical examination must be performed including heart rate, cardiac and pulmonary auscultation.
Danish: Der skal udføres en analyse af sygehistorien og en komplet klinisk undersøgelse, inklusiv hjertefrekvens og auskultation af hjerte og lunger.
English: Treatment with HEMANGIOL should be initiated by physicians who have expertise in the diagnosis, treatment and management of infantile haemangioma, in a controlled clinical setting where adequate facilities for handling of adverse reactions, including those requiring urgent measures, are available.
Danish: Behandling med HEMANGIOL bør initieres af læger, som har ekspertise i diagnosticering, behandling og håndtering af infantil hæmangiom i et kontrolleret klinisk miljø, hvor der findes passende faciliteter til håndtering af bivirkninger/uønskede hændelser, inklusive dem der kræver uopsættelige foranstaltninger.
English: Bradycardia should be diagnosed if the heart rate declines by more than 30 bpm from baseline.
Danish: Bradykardi bør diagnosticeres, hvis hjertefrekvensen falder mere end 30 slag/min fra udgangsværdien.
English: This is because your child can get low blood pressure if given certain anaesthetics while taking this medicine (see “Other medicines and HEMANGIOL”).
Danish: Det skal du gøre, fordi dit barn kan få lavt blodtryk, hvis han/hun modtager visse narkosemidler, mens dette lægemiddel indtages (se “Brug af anden medicin sammen med HEMANGIOL”).
English: Propranolol belongs to a group of medicines known as beta-blockers.
Danish: Propranolol tilhører gruppen af lægemidler kendt som betablokkere.
English: It masks the adrenergic warning signs of hypoglycaemia, particularly tachycardia, shakiness, anxiety and hunger.
Danish: Det maskerer de adrenerge advarselssignaler på hypoglykæmi, specielt takykardi, rystelser, angst og sult.
English: • has very low blood pressure.
Danish: • har meget lavt blodtryk.
English: Do not remove the syringe adapter from the neck of the bottle.
Danish: Tag ikke sprøjteadapteren af flaskehalsen.
English: Beta-blockers will result in an attenuation of reflex tachycardia and an increased risk of hypotension.
Danish: Betablokkere resulterer i en svækkelse af refleks-takykardi og en øget risiko for hypotension.
English: Propranolol may increase the risk of stroke in PHACE syndrome patients with severe cerebrovascular anomalies by dropping blood pressure and attenuating flow through occluded, narrow, or stenotic vessels.
Danish: Propranolol kan øge risikoen for slagtilfælde hos patienter med PHACE-syndrom med alvorlige cerebrovaskulære anomalier, ved at sænke blodtrykket og svække gennemstrømningen gennem okkluderede, snævre eller stenotiske kar.
English: Concerning the lower respiratory tract infections like bronchitis or bronchiolitis, an aggravation of symptoms (including bronchospasm) has been observed in patients treated with HEMANGIOL due to the bronchoconstrictive effect of propranolol.
Danish: Angående infektion i de nedre luftveje, så som bronkitis eller bronchiolitis, blev der observeret en forværring af symptomerne (inklusive bronchospasme) hos patienter behandlet med HEMANGIOL på grund af propranolols bronchokonstriktive effekter.
English: The therapeutic dose is 3 mg/kg/day, which is to be administered into 2 separate doses of 1.5 mg/kg, one in the morning and one in late afternoon, with a time interval of at least 9 hours between two intakes.
Danish: Den terapeutiske dosis er 3 mg/kg/dag, som skal administreres i 2 separate doser på 1,5 mg/kg, én om morgenen og én sent på eftermiddagen, med et tidsinterval på mindst 9 timer mellem de to indtag.
English: In the event of isolated bronchospasm, treatment must be permanently discontinued.
Danish: I tilfælde af isolerede bronkospasmer, skal behandlingen afbrydes permanent.
English: The four major final metabolites are propranolol glucuronide, naphthyloxylactic acid and glucuronic acid, and sulfate conjugates of 4-hydroxy propranolol.
Danish: De fire største endelige metabolitter er propranolol glukuronid, naphthyloxylaktisk syre og glukuronsyre samt sulfatkonjugater af 4-hydroxy propranolol.
English: • It is supplied in a 120-mL amber glass bottle, with a child resistant screw-cap.
Danish: • Det leveres i en 120 ml brun glasflaske, med børnesikret skruelåg.
English: HEMANGIOL may increase potassium blood level (hyperkaliemia).
Danish: HEMANGIOL kan øge kaliumniveauet i blodet level (hyperkaliæmi).
English: The mixing may be done with one teaspoonful (approximately 5 mL) of milk for children weighing up to 5 kg, or with a tablespoonful (approximately 15 mL) of milk or fruit juice for children weighing more than 5 kg, delivered in a baby's bottle.
Danish: Blandingen kan foretages med en teskefuld (ca. 5 ml) mælk til børn, der vejer op til 5 kg, eller med en spiseskefuld (ca. 15 ml) mælk eller frugtjuice til børn, der vejer mere end 5 kg, i en sutteflaske.
English: • HEMANGIOL is a clear, colourless to slightly yellow oral solution, with a fruity odour.
Danish: • HEMANGIOL er en klar, farveløs til lysegul oral opløsning, med en frugtagtig lugt.
English: Very limited safety data of propranolol in PHACE syndrome patients are available.
Danish: Meget begrænsede data er tilgængelige om propranolol hos patienter med PHACE-syndrom.
English: • Step 5: Remove the dose
Danish: • Trin 5: Opmål dosis
English: • Convulsions (fits) linked to hypoglycaemia (abnormally low blood sugar levels),
Danish: • Kramper (anfald) forbundet med hypoglykæmi (unormalt lave blodsukkerniveauer),
English: However, in the study conducted in juvenile animals treated all over the development period corresponding to infancy, childhood and adolescence, no effect on male and female fertilities was observed (See section 4.6).
Danish: I studiet, som blev kørt med unge dyr behandlet over hele udviklingsperioden svarende til spædbarnsalder, barndom og pubertet, blev der dog ikke observeret effekter på fertiliteten hos hverken hanner eller hunner (pkt.
English: • Prinzmetal's angina
Danish: • Prinzmetals angina
English: Stop treatment and contact your doctor immediately if after giving HEMANGIOL to your child you observe the following symptoms suggestive of a bronchospasm (temporary restriction of the bronchial tubes that leads to difficulty breathing): cough, quick or difficult breathing or wheezing, associated or not with a bluish-coloured skin.
Danish: Stands behandlingen og kontakt øjeblikkeligt din læge, hvis du, efter du har givet dit barn HEMANGIOL, observerer følgende symptomer, som kan være tegn på bronchospasme (kortvarig restriktion af bronkierne, der fører til åndedrætsbesvær): hoste, hurtig eller besværet vejrtrækning eller hiven efter vejret, associeret eller ikke med en blålig hud.
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokalde repræsentant for indehaveren af markedsføringstilladelsen.
English: This also applies when children are breastfed by mothers treated with corticosteroids in case of high dosage or prolonged treatment (see section 4.4 concerning hypoglycaemia).
Danish: Dette gælder også, når børn ammes af mødre, der behandles med kortikosteroider i tilfælde af høj dosis eller forlænget behandling (se pkt.
English: Hypotension Vasoconstriction Raynaud's phenomenon
Danish: Hypotension Vasokonstriktion Raynauds syndrom
English: Atrioventricular blocks, intraventricular conduction delays, and congestive heart failure can occur with more severe poisoning.
Danish: Atrioventrikulær blok, intraventrikulær ledningsforsinkelse og hjerteinsufficiens kan forekomme ved mere alvorlige forgiftninger.
English: Very common side effects (may affect more than 1 in 10 people)
Danish: Meget almindelige bivirkninger (kan påvirke mere end 1 ud af 10 personer)
English: • Hypoglycemia may develop and manifestations of hypoglycemia (tremor, tachycardia) may be masked by other clinical effects of beta-blocker toxicity.
Danish: • Hypoglykæmi kan udvikles og hypoglykæmimanifestationer (rysten, takykardi) kan maskeres af andre kliniske effekter af toksiciteten i betablokkere.
English: In particular, in case you are breastfeeding, tell your doctor or pharmacist if you are or if your child is taking:
Danish: I det tilfælde, hvor du ammer, er det især vigtigt at fortælle lægen eller apotekspersonalet, at du eller dit barn tager:
English: • The dose should always be measured using the oral syringe supplied with the bottle.
Danish: • Dosen bør altid måles ved hjælp af den medfølgende orale sprøjte.
English: Cardiac failure:
Danish: Hjerteinsufficiens:
English: • infants given any other medicinal products, notably those mentioned below.
Danish: • børn der får anden samtidig medicin, især dem nævnt nedenfor.
English: If your child has any signs of hypoglycaemia while taking HEMANGIOL, give if possible oral liquid containing sugar and, if symptoms persist, call your doctor right away or go directly to hospital.
Danish: Hvis dit barn viser tegn på hypoglykæmi, mens han/hun tager HEMANGIOL, skal du give ham/hende en væske med sukker via munden, hvis det er muligt, og hvis symptomerne vedvarer, skal du kontakte din læge med det samme eller tage direkte på hospitalet.
English: • Diarrhoea and vomiting.
Danish: • Diarré og opkast.
English: In adult female rats, propranolol given into the uterus or by intravaginal administration is a powerful anti-implantation agent at dose ≥4 mg per animal, the effects being reversible.
Danish: Hos voksne hunrotter er propranolol givet i uterus eller ved intravaginal administration et kraftigt antiimplantationsstof ved dosen ≥4 mg per dyr, med reversibel effekt.
English: Patients with infantile haemangioma may be at increased risk if they have received or are concomitantly receiving treatment with corticosteroids because adrenal suppression may result in loss of the counterregulatory cortisol response and increase the risk of hypoglycaemia.
Danish: Patienter med infantil hæmangiom kan være yderligere udsatte, hvis de har modtaget eller modtager samtidig behandling med kortikosteroider, da adrenal suppression kan forårsage tab af den modregulerende kortisolrespons og øge risikoen for hypoglykæmi.
English: In case the child spits up a dose or does not take all of the medicinal product no other dose should be given before the next scheduled dose.
Danish: Hvis barnet spytter en dosis ud eller ikke tager al medicinen, skal der ikke gives en ny dosis, før den næste planlagte dosis.
English: The advice of a cardiologist should be sought.
Danish: Der bør konsulteres med en kardiolog.
English: • An oral polypropylene syringe graduated in mg of propranolol, is provided with each bottle.
Danish: • En oral polypropylen sprøjte med måleangivelse i mg propranolol leveres sammen med hver flaske.
English: 6 Contents of the pack and other information What HEMANGIOL contains
Danish: 6 PAKNINGSSTØRRELSER OG YDERLIGERE INFORMATION HEMANGIOL indeholder
English: An allergic reaction can include a rash, itching or shortness of breath.
Danish: En allergisk reaktion kan omfatte udslæt, kløe eller åndenød.
English: During this pharmacokinetic study including infants with function-threatening haemangioma, haemangioma in certain anatomic locations that often leave permanent scars or deformity, large facial haemangioma, smaller haemangioma in exposed areas, severe ulcerated haemangioma, pedunculated haemangioma, efficacy was also studied as a secondary evaluation criteria.
Danish: Under dette farmakokinetiske studie, som omfattede børn med funktionstruende hæmangiom, hæmangiom på bestemte anatomiske placeringer, som ofte efterlader permanente ar eller deformitet, stort ansigtshæmangiom, mindre hæmangiom på udsatte områder, alvorlig ulcereret hæmangiom, pedunkuleret hæmangiom, blev effektiviteten også undersøgt som et sekundært evalueringskriterium.
English: If you have given to your child more HEMANGIOL than you should, please consult your doctor immediately.
Danish: Hvis du har givet dit barn for meget HEMANGIOL, skal du øjeblikkeligt kontakte din læge.
English: Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta blockade may precipitate more severe failure.
Danish: Sympatisk stimulation kan være en livsvigtig komponent for at understøtte kredsløbsfunktionen hos patienter med hjerteinsufficiens, og præparatets hæmning af betablokade kan fremtvinge et mere alvorligt svigt.
English: • Bronchospasm (breathing difficulties),
Danish: • Bronchospasme (vejrtrækningsbesvær),
English: • If necessary, you may mix the medicine with a small quantity of baby-milk or age-adapted apple and/or orange fruit juice and give it to your child in a baby bottle.
Danish: • Om nødvendigt kan du blande medicinen med en lille mængde modermælk/modermælkserstatning eller alderspassende æble- og/eller appelsinjuice og give barnet blandingen i en sutteflaske.
English: Halogenated Anesthetic Agents
Danish: Halogenerede anæstesistoffer
English: • Citric acid monohydrate
Danish: • Citronsyremonohydrat
English: • Bronchitis (inflammation of the bronchi),
Danish: • Bronkitis (inflammation i bronkierne),
English: • Disease of the sinus node (including sinoatrial block)
Danish: • Sygdom i sinusknuden (inklusive sinusblok)
English: Heart rate (beats/min)
Danish: Hjertefrekvens (slag/min)
English: 8 MARKETING AUTHORISATION NUMBER(S)
Danish: 8 MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE)
English: Keep the bottle in the outer carton in order to protect from light.
Danish: Opbevar flasken i den ydre emballage for at beskytte den mod lys.
English: In clinical trials for proliferating infantile haemangioma, the most frequently reported adverse reactions in infant treated with HEMANGIOL were sleep disorders (16.7%), aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever, diarrhoea (16.5%), and vomiting (11.5%).
Danish: I kliniske studier af prolifererende infantil hæmangiom er de oftest rapporterede bivirkninger hos spædbørn behandlet med HEMANGIOL søvnforstyrrelser (16,7 %), forværret infektion i åndedrætsorganerne, så som bronkitis og bronchiolitis forbundet med hoste og feber, diarré (16,5 %) og opkast (11,5 %).
English: Lidocaine toxicity (neurological and cardiac adverse events) has been reported following co-administration with propranolol.
Danish: Der er blevet rapporteret om lidocaintoksicitet (neurologiske og kardiologiske bivirkninger) efter samtidig administration af propranolol.
English: Paediatric populations
Danish: Pædiatriske populationer
English: Call your doctor right away if your child has any signs such as tiredness, coldness, pallor, bluish-coloured skin, or fainting while taking HEMANGIOL.
Danish: Ring straks til din læge, hvis dit barn viser tegn på træthed, kulde, bleghed, blålig hud, eller besvimelse, mens det tager HEMANGIOL.
English: In case of acute broncho-pulmonary abnormality, the initiation of the treatment should be postponed.
Danish: I tilfælde af akut bronkopulmonal anomali, skal igangsættelsen af behandlingen udsættes.
English: If you have any further questions, ask your doctor or pharmacist.
Danish: Hvis du har andre spørgsmål, spørg venligst din læge eller apoteker.
English: Infants with large facial infantile hemangioma should be thoroughly investigated for potential arteriopathy associated with PHACE syndrome, with magnetic resonance angiography of the head and neck and cardiac imaging to include the aortic arch, prior to considering propranolol therapy.
Danish: Børn med stort infantil hæmangiom i ansigtet bør undersøges grundigt for potentiel arteriopati forbundet med PHACE-syndrom, med MR-angiografi af hoved og hals og hjerte-imagografi for at inkludere aortabuen, forud for overvejelser om propranololbehandling.
English: Medicinal products inducing orthostatic hypotension Medicinal products that induce postural hypotension (nitrates derivatives, type 5-phosphodiesterase inhibitors, tricyclic antidepressants, antipsychotics, dopaminergic agonists, levodopa, amifostine, baclofen…) may add their effects to that of beta-blockers.
Danish: Lægemidler, der inducerer ortostatisk hypotension Lægemidler, der inducerer postural hypotension (nitratderivater, type 5-fosfodiesterasehæmmere, tricykliske antidepressiver, antipsykotika, dopaminerge agonister, levodopa, amifostin, baclofen …) kan forstærke beta-blokkerenes virkning.
English: Although some reversible effects on male and female fertilities were reported in adult rats receiving high doses of propranolol in the literature, the study performed in juvenile animals did not show any effect on fertility (see section 5.3).
Danish: Selv om der er blevet rapporteret nogle reversible effekter på hanner og hunners fertilitet hos voksne rotter, som havde modtaget høje doser af propranolol, har et studie udført med unge dyr ikke vist effekter på fertiliteten (se pkt.
English: The MAH shall provide an educational pack for the proposed indication, targeting all caregivers who are expected to prepare and administer HEMANGIOL to children.
Danish: Indehaveren af markedsføringstilladelsen skal udlevere en undervisningspakke til det plejepersonale, som forventes at forberede og administrere HEMANGIOL til børn.
English: The main effects reported after repeated administration of propranolol in adult and juvenile rats were a transient decrease in body weight and body weight gain associated with a transient decrease in organ weight.
Danish: Hovedeffekterne rapporteret efter gentagen administration af propranolol hos voksne og unge rotter, var en kortvarig nedsættelse af kropsvægten og vægtforøgelse forbundet med en kortvarig nedsættelse af organvægt.
English: Use of propranolol alongside hypoglycaemic therapy in diabetic patients should be with caution since it may prolong the hypoglycaemic response to insulin.
Danish: Man bør udvise forsigtighed ved brug af propranolol samtidig med en hypoglykæmisk behandling hos patienter med diabetes, da det kan forlænge den hypoglykæmiske respons over for insulin.
English: Propranolol, due to its pharmacological action, may cause or worsen bradycardia or blood pressure abnormalities.
Danish: På grund af sin farmakologiske virkning, kan propranolol forårsage eller forværre bradykardi eller uregelmæssigt blodtryk.
English: • Asthma or history of bronchospasm
Danish: • Astma eller sygehistorie med bronkospasme
English: Propranolol is highly lipid-soluble and may cross the blood brain barrier and cause seizures.
Danish: Propranolol er særdeles lipid-opløseligt og kan krydse hjernens blodbarriere og forårsage kramper.
English: FRANCE
Danish: Frankrig
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natrium-frit.
English: • If your child has a PHACE syndrome (a condition combining haemangioma and vascular abnormalities including cerebral blood vessels), as this medicine may increase the risk of cerebral stroke.
Danish: • Hvis dit barn har et PHACE syndrom (en tilstand, der kombinerer hæmangiom og vaskulære abnormiteter, som omfatter blodkar i hjernen), da denne medicin kan øge risikoen for hjerneblødning.
English: It is necessary to alert the anaesthetist to the fact that the patient is being treated with beta-blockers.
Danish: Det er nødvendigt at advare narkoselægen om, at patienten behandles med betablokkere.
English: Corticosteroids
Danish: Kortikosteroider
English: Respiratory, thoracic and mediastinal disorders
Danish: Åndedræts-, torakale og mediastinale lidelser
English: The following table gives the adverse reactions, reported whatever dose and treatment duration, in three clinical studies, including 435 patients treated by HEMANGIOL at 1 mg/kg/day or 3 mg/kg/day for a maximum treatment duration of 6 months.
Danish: Nedenstående skema viser de bivirkninger, der er indrapporteret uanset dosis og behandlingstid i tre kliniske studier, som inkluderede 435 patienter behandlet med HEMANGIOL 1 mg/kg/dag eller 3 mg/kg/dag i den maksimale behandlingsperiode på 6 måneder.
English: • Erythema (skin redness),
Danish: • Erytem (rødme i huden),
English: In patients likely to experience severe anaphylactic reaction, regardless of origin, particularly with iodinated contrast agents, beta-blocker treatment may lead to worsening of the reaction and resistance to its treatment with adrenaline at normal doses.
Danish: Hos patienter med tilbøjelighed til at opleve alvorlige anafylaktiske reaktioner, uanset oprindelse og især med jodholdige kontrastvæsker, kan behandling med betablokkere føre til forværring af reaktionen og resistens over for behandlingen af den med adrenalin i normale doser.
English: However, several reports of hypoglycaemia with related hypoglycaemic seizure were reported during the compassionate use program and in literature, especially in case of fasting period during intercurrent illness (see section
Danish: Der foreligger dog adskillige rapporter om hypoglykæmi med relateret hypoglykæmisk krampe under programmet for anvendelse med særlig udleveringstilladelse og i litteraturen, især i tilfælde af fasteperiode under samtidig sygdom (se pkt.
English: This medicinal product contains 2.08 mg of propylene glycol/kg/day.
Danish: Dette lægemiddel indeholder 2,08 mg propylenglycol/kg/dag.
English: • The other ingredients are hydroxyethylcellulose, sodium saccharin, strawberry flavour (contains propylene glycol), vanilla flavour (contains propylene glycol), citric acid monohydrate, purified water.
Danish: • De andre indholdsstoffer er hydroxyethylcellulose, natriumsaccharinat, jordbærsmag (indeholder propylenglycol), vaniljesmag (indeholder propylenglycol), citronsyre monohydrat, destilleret vand.
English: HEMANGIOL can decrease blood pressure (hypotension) and heart rate (bradycardia).
Danish: HEMANGIOL kan sænke blodtrykket (hypotension) og hjertefrekvensen (bradykardi).
English: • an antiangiogenic effect (decrease of vascular endothelial cells proliferation, reduction of the neovascularization and formation of vascular tubules, reduction of the secretion of Matrix
Danish: • en antiangiogenisk virkning (nedgang i vaskulær endotelial celleproliferation, reduktion af neovaskularisation og dannelse af vaskulære tubulus, reduktion af udskillelse af Matrix Metalloproteinase 9);
English: Blood pressure (mmHg) 65/45
Danish: Blodtryk (mmHg)
English: • The metabolism of intravenous lidocaine is inhibited by co-administration of propranolol, resulting in a 25% increase in lidocaine concentrations.
Danish: • Metaboliseringen af lidocain hæmmes ved samtidig administration af propranolol, hvilket resulterer i en stigning på 25 % af lidocainkoncentrationer.
English: Store the bottle and the syringe together in the carton until next use in a safe place where your child can't see or reach it.
Danish: Opbevar flasken og sprøjten sammen i papæsken indtil næste brug et sikkert sted, hvor dit barn ikke kan nå den. Kassér sprøjten, når flaskens indhold er opbrugt.
English: • Medicines to treat tuberculosis,
Danish: • Medicin, der behandler tuberkulose,