FrancophonIA/ELRC3.0 huggingface dataset:
English: Other information about Hemangiol
Danish: Andre oplysninger om Hemangiol
English: Treatment should be started by a doctor who has experience in the diagnosis, treatment and management of infantile haemangioma.
Danish: Behandlingen bør indledes og overvåges af en læge med erfaring i diagnosticering, behandling og håndtering af infantilt hæmangiom.
English: Treatment with Hemangiol should last for six months and the child should be monitored once a month, in particular for dose adjustments.
Danish: Behandlingen med Hemangiol bør vare mindst seks måneder, og barnet bør overvåges en gang om måneden, navnlig med henblik på dosistilpasning.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Hemangiol's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Hemangiol opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: It will also provide instructions on how to give the medicine correctly, in order to avoid the risk of low blood sugar levels.
Danish: Pakken skal desuden give anvisninger for korrekt anvendelse af lægemidlet med henblik på at undgå risikoen for forhøjet blodsukker.
English: The dose is progressively increased to a maintenance dose of 1.5 mg/kg twice a day.
Danish: Dosis øges gradvis til en vedligeholdelsesdosis på 1,5 mg/kg to gange dagligt.
English: What measures are being taken to ensure the safe and effective use of Hemangiol?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Hemangiol?
English: Hemangiol was investigated in one main study involving 460 children aged from five weeks to five months at the start of treatment and who had proliferative infantile haemangioma that required systemic therapy.
Danish: Hemangiol blev undersøgt i én hovedundersøgelse med 460 børn, som ved behandlingens påbegyndelse var mellem fem uger og fem måneder gamle, og havde proliferativt infantilt hæmangiom, der krævede systemisk behandling.
English: Why is Hemangiol approved?
Danish: Hvorfor blev Hemangiol godkendt?
English: In around 60% (61 out of 101) of children treated with the most effective dose of Hemangiol (3 mg/kg/day for 6 months), haemangiomas disappeared completely or almost completely compared with around 4% (2 out of 55) in children who received placebo.
Danish: Hos ca. 60 % (61 ud af 101) af de børn, der blev behandlet med den mest effektive dosis af Hemangiol (3 mg/kg/dag i 6 måneder), svandt hæmangiomet fuldstændigt eller næsten fuldstændigt, sammenholdt med ca. 4 % (2 ud af 55) af dem, der fik placebo.
English: Hemangiol must not be used in: premature babies who have not reached the corrected age of 5 weeks (the corrected age is the age a premature baby would be if he/she had been born on the due date); breastfed children if the mother is being treated with medicines that must not be used with propranolol; children with asthma or with a history of bronchospasm; children with certain diseases of the heart and blood vessels, such as low blood pressure; and children who tend to have low blood sugar levels.
Danish: Hemangiol må ikke anvendes til: for tidligt fødte spædbørn, der ikke har nået den korrigerede alder 5 uger (den korrigerede alder er den alder, et for tidligt født spædbørn ville have, hvis det var født til det forventede fødselstidspunkt); brystbørn, når moderen er i behandling med lægemidler, som ikke må anvendes sammen med propranolol; børn med astma eller tidligere bronkospasme; børn med visse hjerte-kar-sygdomme såsom for lavt blodtryk, og børn med tendens til for lavt blodsukker.
English: Hemangiol is used in infants with serious complications, such as painful ulcers, scarring and breathing difficulties, who require systemic therapy (treatment which can have an effect on the whole body).
Danish: Hemangiol anvendes hos børn med alvorlige komplikationer såsom smertefulde sår, ardannelse eller vejrtrækningsbesvær, der kræver systemisk behandling (som virker på hele kroppen).
English: What is Hemangiol and what is it used for?
Danish: Hvad er Hemangiol, og hvad anvendes det til?
English: For more information about treatment with Hemangiol, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Hemangiol, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is not intended to provide practical advice on how to use Hemangiol.
Danish: Det er ikke en praktisk vejledning i, hvordan Hemangiol bør anvendes.
English: The active substance in Hemangiol, propranolol, belongs to a group of medicines called beta-blockers, which have been widely used to treat several conditions in adults, including diseases of the heart and high blood pressure.
Danish: Det aktive stof i Hemangiol, propranolol, tilhører lægemiddelgruppen betablokkere, der har haft udbredt anvendelse til behandling af en række lidelser hos voksne, herunder hjertesygdomme og forhøjet blodtryk.
English: What are the risks associated with Hemangiol?
Danish: Hvilke risici er der forbundet med Hemangiol?
English: The most common side effects with Hemangiol (which may affect more than 1 in 10 children) are sleep disorders, respiratory tract infections such as bronchitis (inflammation of the airways in the lungs), diarrhoea and vomiting.
Danish: De hyppigste bivirkninger ved Hemangiol (som optræder hos mere end 1 ud af 10 børn) er søvnforstyrrelser, luftvejsinfektioner såsom bronkitis, diarré og opkastning.
English: Although it is not exactly known how Hemangiol works in proliferative infantile haemangioma, it is thought to do so by several mechanisms including narrowing the blood vessels and so decreasing blood supply to the haemangioma, blocking the formation of new blood vessels in the growth, triggering cell death of the abnormal blood vessel cells and blocking the effect of certain proteins (called VEGF and bFGF), which are important for the growth of blood vessels.
Danish: Det vides ikke nøjagtigt, hvordan Hemangiol virker ved proliferativt infantilt hæmangiom, men virkningen menes at skyldes flere mekanismer, herunder sammentrækning af blodkarrene med deraf følgende nedsat blodforsyning til hæmangiomet, blokering af dannelsen af nye blodkar i svulsten, udløsning af celledød i de abnorme blodkarceller og blokering af virkningen af visse proteiner (VEGF og bFGF), som er vigtige for blodkars vækst.
English: Hemangiol can only be obtained with a prescription.
Danish: Lægemidlet Hemangiol udleveres kun efter recept.
English: The recommended starting dose of Hemangiol is 0.5 mg per kilogram bodyweight (0.5 mg/kg), twice a day (at least 9 hours apart).
Danish: Den anbefalede startdosis af Hemangiol er 0,5 mg/kg legemsvægt (0,5 mg/kg) to gange dagligt, der gives med mindst 9 timers mellemrum.
English: Serious side effects observed with Hemangiol include bronchospasm (temporary narrowing of the airways) and low blood pressure.
Danish: Alvorlige bivirkninger, der er iagttaget med Hemangiol, er midlertidig forsnævring af luftvejene (bronkospasme) og for lavt blodtryk (hypotension).
English: For the full list of all side effects reported with Hemangiol, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Hemangiol fremgår af indlægssedlen.
English: The Company will provide caregivers who will give Hemangiol to children with an educational pack to inform them of the need to monitor children for certain side effects and how to manage them.
Danish: Virksomheden skal udlevere en informationspakke til børnenes plejere, hvor der oplyses om nødvendigheden af, at børnene overvåges for visse bivirkninger, og behandlingen heraf.
English: The Committee concluded that Hemangiol was an effective treatment for haemangioma.
Danish: CHMP konkluderede, at Hemangiol var effektivt til behandling af hæmangiom.
English: For practical information about using Hemangiol, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Hemangiol, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Hemangiol is available as a solution to be taken by mouth.
Danish: Hemangiol leveres som en opløsning, der indgives gennem munden.
English: How is Hemangiol used?
Danish: Hvordan anvendes Hemangiol?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Hemangiol, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Hemangiol anvendes så sikkert som muligt På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Hemangiol, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Hemangiol at a dose of 3 mg/kg per day (given as two separate doses of 1.5 mg/kg) given for 6 months was shown to be more effective than placebo.
Danish: Hemangiol blev påvist at være mere effektivt end placebo, når det blev givet i en dosis på 3 mg/kg/dag (som to separate doser på 1,5 mg/kg) i seks måneder.
English: What benefits of Hemangiol have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Hemangiol?
English: How does Hemangiol work?
Danish: Hvordan virker Hemangiol?
English: It is used to treat children with proliferating infantile haemangioma, which are benign tumours (abnormal non-cancerous growths) of blood vessels.
Danish: Det anvendes til behandling af børn med prolifererende infantilt hæmangiom, som er en godartet karsvulst.
English: The study compared different doses of propranolol with placebo (a dummy treatment) and the main measure of effectiveness was based on whether the haemangiomas disappeared completely or almost completely after 6 months of treatment.
Danish: Virkningen blev hovedsagelig bedømt på, om hæmangiomerne var svundet fuldstændigt eller næsten fuldstændigt efter 6 måneders behandling.
English: Adopted at the 9-12 April 2018 PRAC
Danish: Vedtaget på PRAC's møde 9.-12. april 2018
English: What you need to know before you take <…>
Danish: Det skal du vide, før du begynder at tage <…>
English: Not known: frequency cannot be estimated from available data
Danish: Ikke kendt: hyppigheden kan ikke bedømmes ud fra de forhåndenværende data
English: Therefore, if you are breastfeeding, your child should receive vitamin K1.
Danish: Hvis du ammer, bør dit barn derfor få vitamin K1.
English: Swelling of the face, lips, tongue or throat
Danish: Hævelse af ansigt, læber eller svælg
English: This means taking <...> during pregnancy can lead to malformations and even death of your unborn child.
Danish: Det indebærer, at indtagelse af <...> under graviditet kan føre til misdannelser af dit ufødte barn og endog dets død.
English: Women of childbearing age who are taking <…> have to use effective contraceptive measures during treatment and should continue for 3 months after the last dose.
Danish: Kvinder i den fødedygtige alder, som tager <...>, skal anvende effektiv antikonception under behandlingen og bør fortsætte dermed i 3 måneder efter den sidste dosis.
English: Frequency not known: pulmonary arterial hypertension
Danish: Hyppighed ikke kendt: pulmonal arteriel hypertension
English: As a precaution, however, prophylaxis involving the administration of vitamin K1 to the infant concerned is recommended.
Danish: Som sikkerhedsforanstaltning anbefales dog profylakse med administration af vitamin K1 til brystbarnet.
English: You must not use <…> when you are pregnant, as it passes from mother to child.
Danish: Du må ikke bruge <…>, hvis du er gravid, da det overføres fra moderen til fosteret.
English: You must prevent becoming pregnant by taking effective contraceptive measures during therapy with <…> and in the period of 3 months after completion of the treatment with <…> due to the increased risk of foetal malformations.
Danish: Du skal undgå at blive gravid ved at bruge effektiv prævention under behandlingen med <...> og i 3 måneder efter afslutning af behandlingen med <...> på grund af den øgede risiko for misdannelser af fostret.
English: No information on effects of <…> on fertility is available.
Danish: Der foreligger ingen oplysninger om virkninger af <…> på fertiliteten.
English: If you wish to get pregnant or if you already became pregnant while taking this medicine, talk to your doctor immediately as you should be switched to a safer alternative treatment (e.g. heparin) if you are planning a pregnancy or immediately after recognition of pregnancy.
Danish: Hvis du ønsker at blive gravid eller allerede er gravid, mens du tager dette lægemiddel, skal du straks kontakte lægen, da du skal skifte til en anden, sikrere behandling (f.eks. heparin), hvis du planlægger graviditet eller straks, når du opdager, at du er gravid.
English: Women of childbearing potential planning a pregnancy should be switched to a safer alternative treatment prior to pregnancy.
Danish: Fertile kvinder, der planlægger graviditet, bør overgå til anden, sikrere behandling inden graviditeten.
English: Phenprocoumon is contraindicated during pregnancy (see section 4.3).
Danish: Phenprocoumon er kontraindiceret under graviditet (se pkt.
English: Phenprocoumon - Risk of birth defects and foetal loss following first trimester exposure as a function of the time of withdrawal (EPITT no 18902)
Danish: Phenprocoumon - Risiko for fosterskader og abort efter eksponering i første trimester, som funktion af seponeringstidspunktet (EPITT nr. 18902)
English: In humans phenprocoumon crosses the placental barrier.
Danish: Phenprocoumon passerer placentabarrieren hos mennesker.
English: Table 2: Tabulated summary of adverse reactions
Danish: Tabel 2: Skematisk oversigt over bivirkninger
English: In nursing mothers, the active ingredient passes into the breast milk, though in such small amounts that no adverse reactions are likely to occur in the infant.
Danish: Hos ammende mødre går det aktive indholdsstof over i modermælken, dog i så små mængder, at det ikke forventes at givebivirkninger hos barnet.
English: If the patient becomes pregnant while taking <…>, the patient should immediately be switched to a safer alternative treatment (e.g. heparin) and close follow-up including level II ultrasound should be recommended.
Danish: Hvis patienten bliver gravid, mens hun er i behandling med <...>, skal hun straks skifte til en anden, sikrere behandling (f.eks. heparin), og der bør anbefales tæt opfølgning, herunder med niveau IIultralyd.
English: Frequency not known: pulmonary arterial hypertension (increased blood pressure in the arteries (blood vessels) of the lungs)
Danish: Hyppighed ikke kendt: pulmonal arteriel hypertension (øget blodtryk i arterierne (blodårerne) i lungerne)
English: There is epidemiological evidence suggesting that the risk of birth defects and foetal death increases with the increasing duration of exposure to phenprocoumon during the first trimester of pregnancy, with a steep increase of the rate of major birth defects when phenprocoumon treatment is continued beyond the 5th gestational week.
Danish: Der er epidemiologiske tegn, der tyder på, at risikoen for fosterskader og fosterdød stiger med stigende varighed af eksponeringen for phenprocoumon i første trimestermed en kraftig stigning i andelen af større fødselsdefekter, når behandlingen med phenprocoumon fortsættes ud over femte graviditetsuge.
English: There is also a risk of bleeding in the foetus (foetal hemorrhage).
Danish: Der er desuden risiko for blødning hos fosteret (føtal hæmoragi).
English: Based on human experience phenprocoumon may cause birth defects and foetal death when administered during pregnancy.
Danish: På baggrund af erfaringer med behandling af mennesker kan phenprocoumon forårsage fosterskader og fosterdød, når det administreres under graviditet.
English: Lapatinib - Pulmonary hypertension (EPITT no 19089)
Danish: Lapatinib - Pulmonal hypertension (EPITT nr. 19089)
English: In cases of exposure to phenprocoumon during second and third trimester of pregnancy, the foetus is at an increased risk of intrauterine or parturitional (cerebral) hemorrhage due to foetal anticoagulation.
Danish: I tilfælde af eksponering for phenprocoumon i andet og tredje trimester er der øget risiko for intrauterin eller fødselsbetinget (cerebral) føtal blødning som følge af antikoagulerende virkning på fosteret.
English: Common: pneumonia (including bacterial, viral, and fungal), upper respiratory tract infection/inflammation, herpes virus infection (including cytomegalovirus-CMV), enterocolitis infection, sepsis (including uncommon cases with fatal outcomes)
Danish: Almindelig: pneumoni (herunder bakteriel, viral og mykotisk), øvre luftvejsinfektion/-inflammation, herpesvirusinfektion (herunder cytomegalovirus (CMV)), enterocolitis, sepsis (herunder ikke almindelige tilfælde med fatalt udfald)
English: If you are breastfeeding, <…> passes into the breast milk, though in such small amounts that no adverse reactions are likely to occur to your child.
Danish: Hvis du ammer, går <...> over i modermælken, dog i så små mængder, at det ikke forventes, at dit barn får bivirkninger.
English: Undesirable effects Tabulated list of adverse reactions Skin and subcutaneous tissue disorders Frequency ‘not known': Angioedema, urticaria
Danish: Oversigt over bivirkninger Hud og subkutane væv Hyppighed "ikke kendt": Angioødem, urticaria
English: Amitriptyline - Dry eye (EPITT no 19173)
Danish: Amitriptylin - Øjentørhed (EPITT nr. 19173)
English: No information is available regarding the influence of <…> on fertility.
Danish: Fertilitet Der foreligger ingen oplysninger om virkningen af <…> på frugtbarheden.
English: Possible side effects Frequency ‘not known': Dry eyes
Danish: Hyppighed "ikke kendt": Tørre øjne
English: Women of childbearing potential / Contraception
Danish: Fertile kvinder/antikonception
English: Common side effects (may affect up to 1 in 10 people) Infections: pneumonia, herpes virus infection (including cytomegalovirus-CMV), upper respiratory tract infection, serious infection of the blood or tissues (including uncommon cases with fatal outcomes)
Danish: Infektioner: lungebetændelse (pneumoni), herpesvirusinfektion (herunder cytomegalovirus (CMV)), øvre luftvejsinfektion, alvorlig infektion i blod eller væv (herunder ikke almindelige tilfælde med fatalt udfald)
English: Dasatinib - Cytomegalovirus (CMV) reactivation (EPITT no
Danish: Dasatinib - Reaktivering af Cytomegalovirus (CMV) (EPITT nr. 19111)
English: Undesirable effects Under SOC ‘Eye disorders' Frequency ‘not known': Dry eye
Danish: Under systemorganklasse "Øjne" Hyppighed "ikke kendt": Øjentørhed
English: Vortioxetine - Angioedema and urticaria (EPITT no
Danish: Vortioxetin - Angioødem og urticaria (EPITT nr. 19099)
English: Hives
Danish: Nældefeber
English: Polio is often only a mild illness.
Danish: Polio er oftest kun en mild sygdom.
English: Frequencies per dose are defined as follows:
Danish: Hyppighederne pr. dosis er defineret som:
English: • Experience in co-administration:
Danish: • Erfaringer med co-administration:
English: The clinical relevance of these observations remains unknown.
Danish: Den kliniske relevans af disse observationer kendes ikke.
English: Reconstitute the vaccine as described above.
Danish: Vaccinen rekonstitueres som beskrevet ovenfor.
English: Freezing destroys the vaccine.
Danish: Frysning ødelægger vaccinen.
English: This is a normal observation.
Danish: Dette er et normalt udseende.
English: The results of these clinical studies are summarised in the tables below.
Danish: Resultaterne fra de kliniske studier er opsummeret i tabellen nedenfor.
English: • Make sure your child finishes the complete vaccination course.
Danish: • Sørg for at dit barn færdiggør hele vaccinationsprogrammet.
English: Each individual pack cannot be sold separately
Danish: Hver enkelt pakning må ikke sælges separat
English: Household contact study (prospective blinded)
Danish: Husstandskontaktstudie (prospektiv blindet)
English: These reactions resolve over an average of 4 days.
Danish: Disse hævelser forsvinder efter gennemsnitligt 4 dage.
English: However, sometimes it can be very serious and cause permanent damage or even death.
Danish: I nogle tilfælde kan den dog være meget alvorlig og medføre permanent skade eller endda død.
English: Polio can make the muscles unable to move (paralysis).
Danish: Polio kan medføre, at musklerne ikke kan bevæges (paralyse).
English: There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
Danish: Der kan optræde omstændigheder, såsom en høj incidens af pertussis, hvor de potentielle fordele opvejer mulige risici.
English: 2 adsorbed on AlPO4
Danish: 2 adsorberet på AlPO4
English: As the benefit of the vaccination is high in these infants, vaccination should not be withheld or delayed.
Danish: Da fordelene ved vaccination er stor for disse børn, bør vaccination ikke udelades eller forsinkes.
English: • Both components are mixed together just before your child receives the injection.
Danish: • De to komponenter skal blandes sammmen, lige før dit barn får injektionen.
English: 40, 8, 32 DU
Danish: 40, 8, 32 DE
English: Stability data indicate that the vaccine components are stable at temperatures up to 25°C for 72 hours.
Danish: Holdbarhedsdata indikerer, at vaccinekomponenterne er stabile i 72 timer ved temperaturer op til 25 °C.
English: • if your child has a severe infection with a high temperature (over 38°C).
Danish: • hvis dit barn har en alvorlig infektion med feber (over 38 °C).
English: Evaluation of pharmacokinetic properties is not required for vaccines.
Danish: Vurdering af farmakokinetiske egenskaber kræves ikke for vacciner.
English: Read all of this leaflet carefully before your child receives this vaccine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden dit barn får denne vaccine, da den indeholder vigtige oplysninger.
English: • Safety in preterm infants:
Danish: • Sikkerhed hos præmature spædbørn:
English: This can cause death by suffocation.
Danish: Dette kan medføre død ved kvælning.
English: These data are intended to guide healthcare professionals in case of temporary temperature excursion only.
Danish: Disse data er kun beregnet som vejledende for sundhedspersonalet i tilfælde af et midlertidigt temperaturudsving.
English: • swelling of the eyes and face
Danish: • hævelse af øjne og ansigt
English: • If additional injections (boosters) are necessary, the doctor will tell you.
Danish: • Hvis supplerende injektioner (boostervaccinationer) er nødvendige, vil lægen give dig besked.
English: The following side effects may happen with this vaccine:
Danish: Følgende bivirkninger kan forekomme med denne vaccine.
English: H-2100 Gödöllö
Danish: H-2100 Gödöllös Ungarn
English: Children at 4-5 years of age
Danish: Børn i alderen 4-5 år
English: Shake well before use
Danish: Omrystes godt før brug
English: They usually happen within 2 to 3 days after vaccination.
Danish: Oftest opstår de inden for de første 2-3 dage efter vaccinationen.
English: The cough may last for one to two months or longer.
Danish: Hosteanfaldene kan vare i 1-2 måneder eller længere.
English: These signs usually start very soon after the injection has been given.
Danish: Sådanne tegn vil som regel opstå lige efter, at injektionen er givet.
English: • The vaccine should never be given into a blood vessel or into the skin.
Danish: • Vaccinen må aldrig gives ind i en blodåre eller lige under huden.
English: Locally established immunoprophylactic measures against hepatitis B should be maintained.
Danish: Lokalt etablerede immunprofylaktiske foranstaltninger mod hepatitis B bør opretholdes.
English: Ask your pharmacist how to throw away medicines your child no longer uses.
Danish: • Spørg på apoteket, hvordan du skal bortskaffe medicinrester, som dit barn ikke længere anvender.
English: This will protect your child against these diseases.
Danish: Dette vil beskytte dit barn mod de omtalte sygdomme.