FrancophonIA/ELRC3.0 huggingface dataset:
English: Thus, the concomitant use of medicinal products that have been associated with renal toxicity and those eliminated by tubular secretion such as NSAIDs, amphotericin B, methotrexate, aminosides, organoplatines, foscarnet, pentamidine, cyclosporin, tacrolimus, acyclovir and valganciclovir, should be avoided particularly during the 5 day clofarabine administration period (see sections 4.4, 4.8 and 5.2).
Danish: Samtidig brug af lægemidler, som er sat i forbindelse med nyretoksicitet, eller som udskilles ved tubulær sekretion som for eksempel NSAID, amphotericin B, methotrexat, aminoglykosider, organoplatiner, foscarnet, pentamidin, ciclosporin, tacrolimus, aciclovir og valganciclovir bør derfor undgås specielt under de fem dages aktiv behandling med clofarabin (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Ivozall 1 mg/ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Ivozall 1 mg/ml koncentrat til infusionsvæske, opløsning
English: (9.1 to -)
Danish: (9,1 til -)
English: Pharmacokinetic data indicate that clofarabine may accumulate in patients with decreased creatinine clearance (see section 5.2).
Danish: Farmakokinetiske data indikerer imidlertid, at clofarabin akkumuleres hos patienter med nedsat kreatininclearance (se pkt.
English: Enterocolitis may lead to necrosis, perforation or sepsis complications and may be associated with fatal outcome (see section 4.4).
Danish: Enterocolitis kan medføre komplikationer i form af nekrose, perforation eller sepsis og kan have letalt udfald (se pkt.
English: A 25% dose reduction may be warranted in patients experiencing significant toxicities (see below).
Danish: Hos patienter med signifikant toksicitet (se nedenfor) kan 25 % dosisreduktion være påkrævet.
English: Overall remission (OR) Rate
Danish: Total remission (TR)
English: Common (may affect up to 1 in 10 people): - infections of the blood, pneumonia, shingles, implant infections, infections of the mouth such as thrush and cold sores; - changes in blood chemistry, changes in white blood cells; - allergic reactions; - feeling thirsty and producing darker or less urine than normal, decreased or loss of appetite,
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 patienter): - infektioner i blodet, lungebetændelse, helvedesild, infektioner omkring implantater, infektioner i munden såsom trøske og forkølelsessår; - forandringer i blodbilledet, forandringer i de hvide blodlegemer; - allergiske reaktioner; - tørst og mørkfarvet urin eller mindre urin end normalt, nedsat eller manglende appetit, vægttab; - ophidselse, irritabilitet eller rastløshed; - følelsesløshed eller svækkelse i arme og ben, følelsesløshed i huden, søvnighed, svimmelhed,
English: Ivozall 1 mg/ml concentrate for solution for infusion clofarabine
Danish: Ivozall 1 mg/ml koncentrat til infusionsvæske, opløsning clofarabin
English: Each vial of Ivozall contains 70.77 mg of sodium.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Et hætteglas Ivozall indeholder 70,77 mg natrium.
English: Your doctor will work out the dose that is right for you depending on your height, weight and how well you are.
Danish: Ud fra din højde, vægt og tilstand beregner din læge hvor stor en dosis du skal have.
English: Nephrotoxic medicinal products, tumour lysis, and tumour lysis with hyperuricemia may contribute to renal toxicity (see sections 4.3 and 4.4).
Danish: Nefrotoksiske præparater, tumorlyse og tumorlyse med hyperurikæmi kan bidrage til nyretoksicitet (se pkt.
English: How to use Ivozall
Danish: Sådan får du Ivozall
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 20 ml vial contains 20 mg of clofarabine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et 20 ml hætteglas indeholder 20 mg clofarabin.
English: There are currently insufficient data to establish the safety and efficacy of clofarabine in adult patients (see section 5.2).
Danish: Erfaringsgrundlaget er endnu utilstrækkeligt til at påvise clofarabins sikkerhed og effekt hos voksne patienter (se pkt.
English: 10.8 l/h/m2
Danish: 10,8 l/time/m2
English: Dose related toxicities on male reproductive organs have been observed in mice, rats and dogs, and toxicities on female reproductive organs have been observed in mice (see section 5.3).
Danish: Dosisrelateret toksisk påvirkning af kønsorganerne er observeret hos hanmus, hanrotter og hanhunde, og der er observeret toksisk påvirkning af kønsorganerne hos hunmus (se pkt.
English: The concomitant use of medicinal products that have been associated with hepatic toxicity should be avoided wherever possible (see sections 4.5 and 4.8).
Danish: Samtidig anvendelse af lægemidler, der er sat i forbindelse med levertoksicitet, bør så vidt muligt undgås (se pkt.
English: - feeling numb or weak in the arms and legs, numbness of the skin, sleepiness, dizziness, tremor; - hearing problems; - water collecting around the heart, fast heartbeat; - low blood pressure, lump due to bad bruising; - leaking from tiny blood vessels, rapid breathing, nosebleeds, breathing difficulties,
Danish: skælven; - problemer med hørelsen; - væskeansamlinger omkring hjertet, hurtig hjertebanken; - lavt blodtryk, buler ved større blå mærker; - små punktformede blødninger, hurtig vejrtrækning, næseblod, åndedrætsbesvær, åndenød,
English: (6.1 to -)
Danish: (6,1 til -)
English: Discard unused contents appropriately.
Danish: Ikke-anvendt produkt bortskaffes på en hensigtsmæssig måde.
English: Further treatment with clofarabine, generally at a lower dose, can be considered when patients are stabilised and organ function has returned to baseline.
Danish: Når patienten er stabiliseret, og organfunktionen atter er som ved baseline, kan det overvejes at fortsætte behandlingen med clofarabin, dog generelt i en lavere dosis.
English: Tell your doctor or carer immediately if you experience any of the following as you may need to stop treatment: - if you get a fever or high temperature - because clofarabine reduces the number of blood cells made in the bone marrow, you may be more likely to catch infections; - if you have breathing difficulties, rapid breathing, or breathlessness; - if you feel a change in your heart rate; - if you suffer from dizziness (light-headedness) or fainting - it may be a symptom of low blood pressure; - if you feel sick or have diarrhoea (loose bowels); - if your urine is darker than usual - it is important to drink plenty of water to avoid dehydration; - if you get a rash with blisters or mouth ulcers; - if you lose your appetite, have nausea (feeling sick), vomiting, diarrhea, dark-colored urine and light-coloured stools, stomach pain, jaundice (yellowing of the skin and eyes), or if you feel generally unwell, these could be symptoms of an inflammation of the liver (hepatitis), or liver damage (hepatic failure); - if you pass little or no urine, or experience drowsiness, nausea, vomiting, breathlessness, loss of appetite and / or weakness (these may be signs of acute kidney failure / kidney failure).
Danish: Da clofarabin nedsætter dannelsen af blodlegemer i knoglemarven, har du en øget risiko for at få en infektion; - hvis du har vejrtrækningsbesvær, hurtig vejrtrækning eller åndenød; - hvis du mærker forandringer i hjertets banken; - hvis du lider af svimmelhed (uklarhed) eller besvimelsesanfald, da det kan være et symptom på lavt blodtryk; - hvis du får kvalme eller diarré (tynd mave); - hvis urinen er mørkere end sædvanligt - det er vigtigt at drikke rigeligt med vand for at undgå væskemangel; - hvis du får udslæt med blærer eller sår i munden; - hvis du mister appetitten, har kvalme (føler dig syg), kaster op, diarré, mørk urin og lys afføring,
English: Treatment cycles should be repeated every 2 to 6 weeks (from the starting day of the previous cycle) following recovery of normal haematopoiesis (i.e. ANC ≥ 0.75 × 109/l) and return to baseline organ function.
Danish: - 6. uge (beregnet fra første dag i den foregående cyklus), når normal hæmatopoiese er genoprettet (ANC
English: Common: Respiratory distress, epistaxis, dyspnoea, tachypnoea, cough
Danish: Luftveje, thorax og mediastinum Almindelig: Respirationshæmning, epistaxis, dyspnø, takypnø, hoste
English: Neoplasms benign and malignant (including cysts and polyps)
Danish: cyster og polypper)
English: Each 20 ml vial contains 70.77 mg of sodium .
Danish: Hjælpestof, som behandleren skal være opmærksom på Et 20 ml hætteglas indeholder 70,77 mg natrium.
English: The excretion of clofarabine in milk has not been studied in animals.
Danish: Det er ikke undersøgt hos dyr, om clofarabin udskilles i mælken.
English: Warnings and precautions Tell your doctor if any of these apply to you.
Danish: Fortæl det til din læge, hvis et af disse punkter passer på dig.
English: What you need to know before you use Ivozall 3.
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du begynder at få Ivozall Sådan får du Ivozall
English: *Each ml of concentrate contains 1 mg of clofarabine.
Danish: *1 ml koncentrat indeholder 1 mg clofarabin.
English: If you are pregnant or you become pregnant during treatment with clofarabine, get medical advice immediately.
Danish: Søg omgående lægehjælp, hvis du er gravid, eller hvis du bliver gravid under behandlingen.
English: VOD cases reported during the post-marketing period in paediatric and adult patients have been associated with a fatal outcome (see section 4.4).
Danish: Efter markedsføring er der indberettet tilfælde af VOD forbundet med letalt udfald hos pædiatriske og voksne patienter (se pkt.
English: Median overall survival (weeks) (95% CI)
Danish: Median total overlevelse (uger)
English: Each ml contains 1 mg of clofarabine.
Danish: Hver ml koncentrat indeholder 1 mg clofarabin.
English: The limited data available indicate that clofarabine may accumulate in patients with decreased creatinine clearance (see sections 4.4 and 5.2).
Danish: De begrænsede data, der foreligger, tyder på, at clofarabin akkumuleres hos patienter med nedsat kreatininclearance (se pkt.
English: What Ivozall looks like and contents of the pack Ivozall is a concentrate for solution for infusion.
Danish: Ivozall er et koncentrat til infusion, opløsning.
English: It works best against cells which are multiplying quickly - such as cancer cells.
Danish: Clofarabin virker ved at hindre væksten af disse abnorme hvide blodlegemer og i sidste ende dræbe dem. Lægemidlet virker bedst på celler, der formerer sig hurtigt, såsom kræftceller.
English: If a patient experiences a hematologic toxicity of Grade 4 neutropaenia (ANC < 0.5 x 10
Danish: Hvis en patient får hæmatologisk toksicitet i form af neutropeni grad 4 (ANC < 0,5 x 109/l), som varer ≥ 4 uger, skal dosis nedsættes med 25 % i den næste cyklus.
English: Your doctor will carry out regular blood tests to check whether your body is working properly; - liver damage (liver failure).
Danish: Din læge vil regelmæssigt tage blodprøver for at checke, om din organisme fungerer ordentligt; - leverskade (leversvigt) som kan være dødelig; - afgiver lidt eller ingen urin, døsighed, kvalme, opkastning, åndenød, tab af appetit og/eller svaghed (mulige tegn på akut nyresvigt eller nyresvigt).
English: Common: Pain in extremity, myalgia, bone pain, chest wall pain, arthralgia, neck and back pain
Danish: Almindelig: Smerter i ekstremiteter, myalgi, knoglesmerter, smerter i thoraxvæg, artralgi, nakke- og rygsmerter
English: This means that due to the rarity of the disease it has not been possible to obtain complete information on the reference medicinal product.The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary accordingly to the reference medicinal product SmPC.
Danish: Det Europæiske Lægemiddelagentur vil hvert år vurdere nye oplysninger om referencelægemidlet, og produktresuméet vil om nødvendigt blive ajourført i overensstemmelse med produktresuméet for referencelægemidlet.
English: Therefore, clofarabine should be used with caution in patients with mild to moderate renal insufficiency (see section 4.2 for dose adjustments).
Danish: Derfor bør clofarabin anvendes med forsigtighed til patienter med mild til moderat nedsættelse af leverfunktionen (se pkt.
English: Breast-feeding
Danish: Clofarabin
English: OTHER
Danish: Hjerte
English: 200 ml *Each ml of concentrate contains 1 mg of clofarabine.
Danish: Total fortyndingsvolumen 100 ml 150 ml 200 ml *1 ml koncentrat indeholder 1 mg clofarabin.
English: - little or no urine, drowsiness, nausea, vomiting, breathlessness, loss of appetite and /or weakness (possible signs of acute kidney failure or kidney failure).
Danish: mavesmerter, gulsot (gulfarvning af hud og øjne) eller hvis du generelt føler dig utilpas, dette kan være symptomer på en inflammation i leveren (hepatitis) eller leverskade (leversvigt); - hvis du afgiver lidt eller ingen urin, eller oplever døsighed, kvalme, opkastning, åndenød, tab af appetit og/eller svaghed (disse symptomer kan være tegn på akut nyresvigt/nyresvigt).
English: Common: Weight decreased
Danish: Almindelig: Vægttab
English: weight loss; - agitation, irritability, or restlessness;
Danish: • angst, hovedpine, feber, træthed;
English: Therefore, clofarabine should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2 and 4.3).
Danish: 4.3) og bør anvendes med forsigtighed til patienter med mild til moderat leverfunktionsnedsættelse (se pkt.
English: What information is still awaited?
Danish: Hvilke oplysninger afventes stadig?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Adjupanrix on 19 October 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Adjupanrix den 19. oktober 2009.
English: The vaccine has been authorised under ‘exceptional circumstances'.
Danish: Vaccinen er blevet godkendt under ‘særlige omstændigheder'.
English: The full EPAR for Adjupanrix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Adjupanrix find s på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Adjupanrix.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Adjupanrix.
English: These patients needed double doses of the vaccine for protection.
Danish: Disse patienter havde behov for dobbelte doser af vaccinen for at opnå beskyttelse.
English: There are some data supporting the use of half-doses (0.25 ml) in children three to nine years of age.
Danish: Der foreligger visse data, som underbygger brugen af halve doser (0,25 ml) til børn i alderen tre til ni år.
English: For more information about treatment with this vaccine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med denne vaccine, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The vaccine contains a flu strain called ‘A/VietNam/1194/2004 NIBRG 14' (H5N1).
Danish: Vaccinen indeholder en influenzavirusstamme kaldet ‘A/VietNam/1194/2004 NIBRG 14' (H5N1).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Adjupanrix.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Adjupanrix.
English: The company that made the Pandemrix H5N1 mock-up vaccine has agreed that its scientific data can be used for this vaccine.
Danish: Virksomheden, som fremstiller Pandemrix H5N1-mockup-vaccinen, har indvilget i, at dens videnskabelige data kan anvendes til denne vaccine.
English: Why has Adjupanrix been approved?
Danish: Hvorfor blev Adjupanrix godkendt?
English: In elderly people, single doses also met the CHMP's criteria, except for in the small number of patients aged over 80 years who did not have any protection against the virus at the start of the study.
Danish: Hos ældre opfyldte enkeltdoserne også CHMP's kriterier, bortset fra det lille antal patienter over 80 år, som ikke havde nogen beskyttelse mod virusset ved undersøgelsens begyndelse.
English: At 21 days after the second injection, 84% of the people receiving the vaccine had levels of antibodies that would protect them against H5N1.
Danish: 21 dage efter den anden injektion havde 84 % af de personer, der havde fået vaccinen, antistofniveauer, som kunne beskytte dem mod H5N1.
English: The CHMP decided that the vaccine's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved vaccinen opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: This vaccine is the same as the Pandemrix H5N1 mock-up vaccine, which was previously authorised in the European Union (EU).
Danish: Denne vaccine er den samme som Pandemrix H5N1-mockup-vaccinen, der tidligere er godkendt i Den Europæiske Union (EU).
English: The vaccine is given by injection into the shoulder or thigh muscle.
Danish: Vaccinen gives ved injektion i skulder- eller lårmusklen.
English: Adults over 80 years of age may need a double dose of the vaccine (one injection into each shoulder) with a second double dose three weeks later.
Danish: Voksne over 80 år kan have behov for en dobbelt dosis af vaccinen (en injektion i hver skulder) med endnu en dobbelt dosis igen tre uger senere.
English: The vaccine must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at very low levels in the vaccine, such as eggs, chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate.
Danish: Vaccinen må ikke gives til personer, der har haft en anafylaktisk reaktion (svær allergisk reaktion) over for en af vaccinens komponenter eller over for et af de sporstoffer, den indeholder (meget lavt), f.eks. æg, kyllingeprotein, ovalbumin (et protein i æggehvide), formaldehyd, gentamicinsulfat (et antibiotikum) og natriumdeoxycholat.
English: The main measures of effectiveness were the levels of antibodies against the flu virus in the blood at three different times: before vaccination, on the day of the second injection (day 21) and 21 days later (day 42).
Danish: Virkningen blev hovedsagelig bedømt på mængden af antistoffer mod influenzavirusset i blodet på tre forskellige tidspunkter: inden vaccination, på dagen for anden injektion (dag 21) og 21 dage senere (dag 42).
English: What is Adjupanrix?
Danish: Hvad er Adjupanrix?
English: According to criteria laid down by the CHMP, a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Danish: Ifølge de kriterier, der er fastsat af CHMP, skal en mockup-vaccine frembringe en beskyttende mængde antistoffer hos mindst 70 % af personerne for at kunne anses for egnet.
English: When the company that makes the vaccine includes the flu strain responsible for a pandemic in the vaccine, it will collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.
Danish: Når virksomheden, som fremstiller vaccinen, inkluderer den influenzastamme, som er ansvarlig for pandemien, i vaccinen, skal den indsamle oplysninger om sikkerhed og virkning af den endelige pandemivaccine og forelægge disse for CHMP til evaluering.
English: Other information about Adjupanrix
Danish: Andre oplysninger om Adjupanrix:
English: Before use, the vaccine will be made up by mixing together a suspension that contains the virus particles with a solvent.
Danish: Inden brug skal vaccinen gøres klar ved at blande en suspension, der indeholder viruspartiklerne, med en solvens.
English: The participants received two injections of the vaccine containing one of four different doses of haemagglutinin.
Danish: Deltagerne fik to injektioner med vaccinen, som indeholdt en af fire forskellige doser af hæmagglutinin.
English: What is the risk associated with this vaccine?
Danish: Hvilken risiko er der forbundet med denne vaccine?
English: Adjupanrix is a vaccine that is given by injection.
Danish: Adjupanrix er en vaccine, som gives ved injektion.
English: For the full list of all side effects reported with this vaccine, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved denne vaccine fremgår af indlægssedlen.
English: It should only be used once a flu pandemic has been officially declared by the World Health Organization (WHO) or European Union (EU).
Danish: Det er en vaccine, der kun må bruges, når Verdenssundhedsorganisationen (WHO) eller Den Europæiske Union (EU) officielt har erklæret, at der er udbrudt en pandemi.
English: People who have previously been vaccinated with a prepandemic vaccine that contains a similar flu strain to the one causing the pandemic will only need one single dose.
Danish: Personer, som tidligere er blevet vaccineret med en præpandemisk vaccine, der indeholder en influenzastamme, som ligner den, der forårsager pandemien, har kun behov for en enkelt dosis.
English: Adjupanrix is a vaccine for use in adults to protect against ‘pandemic' flu.
Danish: Adjupanrix er en vaccine til beskyttelse af voksne mod ‘pandemisk' influenza.
English: During a pandemic, the virus strain in the vaccine will have to be replaced by the strain causing the pandemic before the vaccine can be used.
Danish: Under en pandemi skal virusstammen i vaccinen erstattes med den stamme, der forårsager pandemien, inden vaccinen kan bruges.
English: The most common side effects with the vaccine (seen with more than 1 in 10 doses of the vaccine) are headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (hardening, swelling, pain and redness), fever and fatigue (tiredness).
Danish: De hyppigste bivirkninger ved vaccinen (som optræder hos flere end 1 ud af 10 doser af vaccinen) er hovedpine, ledsmerter, muskelsmerter, reaktioner på injektionsstedet (hårdhed, hævelse, smerte og rødme), feber og træthed.
English: The main study of the vaccine included 400 healthy adults aged between 18 and 60 years and compared the ability of different doses of the vaccine, with or without the adjuvant, to trigger the production of antibodies (‘immunogenicity').
Danish: Hovedundersøgelsen af vaccinen omfattede 400 raske voksne i alderen 18-60 år og sammenlignede vaccinens evne i forskellige doser med eller uden adjuvans til at udløse dannelse af antistoffer (‘immunogenicitet').
English: People who have not previously been vaccinated against the pandemic flu with a ‘prepandemic' vaccine should receive two single 0.5 ml doses of the vaccine at least three weeks apart.
Danish: Personer, som ikke tidligere er blevet vaccineret mod den pandemiske influenza med en ‘præpandemisk' vaccine, skal have to enkeltdoser af vaccinen med mindst tre ugers mellemrum.
English: The main study showed that the 3.75 microgram dose of the adjuvanted vaccine produced an antibody response that met these criteria.
Danish: Hovedundersøgelsen viste, en 3,75 mikrograms dosis af den adjuverede vaccine udløste en antistofrespons, der opfyldte disse kriterier.
English: The final two studies in adults showed that a single dose of the vaccine was sufficient to bring about protective levels of antibodies in people who had previously been vaccinated with a prepandemic vaccine containing a related flu strain.
Danish: De sidste to undersøgelser af voksne viste, at en enkelt dosis af vaccinen var tilstrækkelig til at sikre beskyttende antistofmængder hos personer, som tidligere var blevet vaccineret med en præpandemisk vaccine, der indeholdt en beslægtet influenzastamme.