FrancophonIA/ELRC3.0 huggingface dataset:
English: Carmustine affected the fertility of male rats at doses higher than the human dose.
Danish: Carmustin påvirkede fertiliteten hos hanrotter ved doser over den humane dosis.
English: Reconstitution and dilution, as recommended, results in a clear, colourless to light yellow stock solution which has to be further diluted with 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection, or glucose 50 mg/ml (5%) solution for injection.
Danish: Ved rekonstitution og fortynding i henhold til det anbefalede fås en klar, farveløs til lysegul stamopløsning, som skal fortyndes yderligere med 500 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, eller glucose 50 mg/ml (5 %) injektionsvæske, opløsning.
English: Risk factors include smoking, the presence of a respiratory condition, pre-existing radiographic abnormalities, sequential or concomitant thoracic irradiation and association with other agents that cause lung damage.
Danish: Til risikofaktorerne hører rygning, luftvejssygdomme, præeksisterende radiografiske abnormiteter, sekventiel eller samtidig thoraxbestråling og sammenhæng med andre stoffer, der forårsager lungebeskadigelse.
English: Reconstitution and dilution of the powder for concentrate for solution for infusion: Dissolve the 100 mg Carmustine powder for concentrate for solution for infusion with 3 ml of the supplied sterile refrigerated ethanol solvent in the primary packaging (brown glass vial).
Danish: Rekonstitution og fortynding af pulveret til koncentrat til infusionsvæske, opløsning: Opløs de 100 mg carmustin pulver til koncentrat til infusionsvæske, opløsning med 3 ml af det medfølgende sterile, nedkølede ethanol-solvens i den primære emballage (det brune hætteglas).
English: Avoid skin contact with concentrate for solution for infusion.
Danish: Undgå hudkontakt med koncentrat til infusionsvæske, opløsning.
English: Severe bone marrow depression.
Danish: Svær knoglemarvsdepression
English: The carmustine powder for concentrate for solution for infusion contains no preservative and is not intended as a multiple dose vial.
Danish: Carmustin pulver til koncentrat til infusionsvæske, opløsning, indeholder intet konserveringsstof og er ikke bestemt til at være et flerdosishætteglas.
English: Phlebitis.
Danish: Flebitis.
English: Infusion of Carmustine Obvius in less than one hour may produce intense pain and burning at the site of injection (see section 4.2).
Danish: Hvis Carmustine Obvius infunderes i et tidsrum på under 1 time, kan det medføre intensiv smerte og brændende fornemmelse på injektionsstedet (se pkt.
English: The Carmustine Obvius powder for concentrate for solution for infusion contains no preservative and is not intended as multiple dose vial.
Danish: Carmustine Obvius, pulver til koncentrat til infusionsvæske, opløsning, indeholder intet konserveringsstof og er ikke bestemt til at være et flerdosishætteglas.
English: The pH and osmolarity of ready-to-use solutions for infusion: pH 4.0 to 5.0 and 385-397 mOsm/l (if diluted in glucose 50 mg/ml [5%] solution for injection) and pH 4.0 to 6.8 and 370-378 mOsm/l (if diluted in sodium chloride 9 mg/ml [0.9%] solution for injection).
Danish: pH og osmolaritet af færdige opløsninger klar til infusion er: pH 4,0 til 5,0 og 385-397 mOsm/l (ved fortynding i glucose 50 mg/ml [5 %] injektionsvæske, opløsning) og pH 4,0 til 6,8 og 370-378 mOsm/l (ved fortynding i natriumchlorid 9 mg/ml [0,9 %] injektionsvæske, opløsning).
English: Carmustine Obvius is a powder and solvent for concentrate for solution for infusion.
Danish: Carmustine Obvius er et pulver og et opløsningsmiddel til koncentrat til infusionsvæske, opløsning.
English: Powder for concentrate for solution for infusion 100 mg
Danish: Pulver til koncentrat til infusionsvæske, opløsning 100 mg
English: One pack contains one vial with 100 mg of powder for concentrate for solution for infusion and one ampoule with 3 ml of solvent.
Danish: En pakning indeholder ét hætteglas med 100 mg pulver til koncentrat til infusionsvæske, opløsning, og én ampul med 3 ml solvens.
English: in children and adolescents if you are breast-feeding.
Danish: hvis du har nedsat nyrefunktion i større grad hos børn og unge hvis du ammer
English: Powder and solvent for concentrate for solution for infusion.
Danish: Pulver og solvens til koncentrat til infusionsvæske, opløsning.
English: In combination with chemotherapeutic medicinal products reduced activity of antiepileptic medicinal products must be anticipated.
Danish: Phenytoin og dexamethason Antiepileptika i kombination med kemoterapeutika må forventes at have reduceret aktivitet.
English: If you use more Carmustine Obvius than you should
Danish: Hvis du har fået for meget Carmustine Obvius
English: Each vial of powder for concentrate for solution for infusion contains 100 mg carmustine.
Danish: Hvert hætteglas med pulver til koncentrat til infusionsvæske, opløsning, indeholder 100 mg carmustin.
English: Powder No excipients.
Danish: Pulver Ingen hjælpestoffer.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING POWDER VIAL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE HÆTTEGLAS MED PULVER
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER AMPUL MED SOLVENS
English: Package leaflet: Information for the user Carmustine Obvius 100 mg powder and solvent for concentrate for solution for infusion carmustine
Danish: Indlægsseddel: Information til brugeren Carmustine Obvius 100 mg pulver og solvens til koncentrat til infusionsvæske, opløsning carmustin
English: The 30 ml stock solution is to be diluted immediately by adding the 30 ml stock solution to either 500 ml 5% glucose or 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection in glass containers.
Danish: De 30 ml stamopløsning skal straks fortyndes ved, at de 30 ml stamopløsning tilsættes enten 500 ml 5 % glucose eller 500 ml NaCl 9 mg/ml (0,9 %) injektionsvæske, opløsning, i glasbeholdere.
English: Tell your doctor immediately if you experience any of the following symptoms: shortness of breath, persistent cough, chest pain, persistent weakness/tiredness.
Danish: Fortæl det straks til lægen, hvis du bemærker nogen af følgende symptomer: åndenød, vedvarende hoste, brystsmerter, vedvarende svaghed/træthed - Svær kvalme og opkastning - Ved anvendelse på huden, betændelse i huden (dermatitis) - Utilsigtet kontakt med huden kan medføre forbigående mørkfarvning af et område af huden eller neglene (hyperpigmentering)
English: The 30 ml stock solution is to be diluted immediately by adding the 30 ml stock solution to either 500 ml glucose 50 mg/ml (5%) solution for injection or 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection in glass containers.
Danish: 30 ml stamopløsningen skal straks fortyndes ved, at 30 ml stamopløsningen tilsættes enten 500 ml glucose 50 mg/ml (5 %) injektionsvæske, opløsning, eller 500 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, i glasbeholdere.
English: 1 ampoule of 3 ml solvent
Danish: 1 hætteglas med 100 mg pulver 1 ampul med 3 ml solvens
English: Nausea and vomiting - severe
Danish: Kvalme og opkastning af svær grad
English: What Carmustine Obvius is and what it is used for What you need to know before Carmustine Obvius is given to you How to use Carmustine Obvius
Danish: Det skal du vide, før du begynder at bruge Carmustine Obvius Sådan skal du bruge Carmustine Obvius Bivirkninger
English: Symptoms may include muscle weakness in one area, poor decision-making or concentration, involuntary twitching, trembling, difficulty speaking or swallowing, seizures; - Anorexia; - Constipation; - Diarrhoea; - Inflammation of the mouth and lips; - Reversible liver toxicity in high-dose therapy.
Danish: Symptomerne kan omfatte muskelsvækkelse inden for et område, svækket dømmekraft eller dårlig koncentration, ufrivillige trækninger, rysten, tale- eller synkebesvær og krampeanfald
English: - Solvent: Ethanol, anhydrous.
Danish: - Opløsningsmiddel: Ethanol, vandfri
English: PC:
Danish: PC: (produktkode):
English: - Excipients: - Powder: No excipients.
Danish: - Øvrige indholdsstoffer: - Pulver: Ingen øvrige indholdsstoffer.
English: Carmustine Obvius 100 mg powder and solvent for concentrate for solution for infusion
Danish: Carmustine Obvius, 100 mg pulver og solvens til koncentrat til infusionsvæske, opløsning
English: After reconstitution and dilution, the solution should be administered within 3 hours after reconstitution and dilution of the product.
Danish: Efter rekonstitution og fortynding bør opløsningen administreres inden for 3 timer.
English: Use of carmustine in children and adolescents < 18 years is contraindicated, see section 4.3.
Danish: Carmustin er kontraindiceret til børn og unge <18 år (se pkt.
English: Posology
Danish: Initialdoser
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription, such as: Phenytoin, used in epilepsy
Danish: Fortæl det til lægen eller apotekspersonalet, hvis du bruger anden medicin, har gjort det for nylig eller måske vil gøre det.
English: Very common (may affect more than 1 in 10 people) - Delayed myelosuppression (decrease in blood cells in bone marrow) which can increase the chance of infections if white blood cells are decreased - Ataxia (lack of voluntary coordination of muscle movements); - Dizziness; - Headache; - Transient redness in the eye, blurred vision due to retinal bleeding; - Hypotension (fall in blood pressure); - Phlebitis (inflammation of the veins) associated with pain, swelling, redness, tenderness; - Respiratory disorders (lung related disorders) with breathing problems;
Danish: - Ataksi (manglende evne til at koordinere muskelbevægelserne) - Svimmelhed - Hovedpine - Forbigående rødme i øjnene, sløret syn som følge af blødning i nethinden - Hypotension (fald i blodtrykket)
English: Carmustine Obvius 100 mg powder for concentrate for solution for infusion carmustine
Danish: Carmustine Obvius, 100 mg pulver til koncentrat til infusionsvæske, opløsning carmustin
English: Carmustine Obvius 100 mg powder and solvent for concentrate for solution for infusion carmustine
Danish: Carmustine Obvius, 100 mg pulver og solvens til koncentrat til infusionsvæske, opløsning carmustin
English: SN:
Danish: SN: (serienummer):
English: SOLVENT AMPOULE
Danish: Mave-tarm-kanalen
English: Solvent Ethanol, anhydrous.
Danish: Opløsningsmiddel Ethanol, vandfri
English: Gynecomastia.
Danish: Gynækomasti.
English: The infusion should last around 1 to 2 hours.
Danish: Infusionen skal vare ca. 1 til 2 timer.
English: Regarding safety, no major issues have been identified and serious side effects were rare or manageable.
Danish: Sikkerhedsmæssigt er der ikke fundet større problemer, og alvorlige bivirkninger var sjældne eller håndterbare.
English: Other information about Kanuma
Danish: Andre oplysninger om Kanuma
English: However, further data are needed on the long-term benefits and safety of the medicine.
Danish: Der behøves dog mere viden om lægemidlets fordele og sikkerhed på lang sigt.
English: If antibodies develop, Kanuma may not work effectively.
Danish: Hvis der dannes antistoffer, vil Kanuma muligvis ikke virke effektivt.
English: This is a summary of the European public assessment report (EPAR) for Kanuma.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Kanuma.
English: The recommended dose is 1 mg per kilogram body weight given once every other week.
Danish: Den anbefalede dosis er 1 mg/kg legemsvægt, der gives én gang hver anden uge.
English: A risk management plan has been developed to ensure that Kanuma is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Kanuma anvendes så sikkert som muligt.
English: The most serious side effects with Kanuma (seen in around 3 patients in 100) are signs and symptoms of severe allergic reactions.
Danish: De alvorligste bivirkninger med Kanuma (der optræder hos ca. 3 ud af 100 patienter) er tegn og symptomer på svære allergiske reaktioner.
English: What is Kanuma and what is it used for?
Danish: Hvad er Kanuma, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Kanuma?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Kanuma?
English: Why is Kanuma approved?
Danish: Hvorfor blev Kanuma godkendt?
English: Growth improvements were also observed in all 6 surviving infants.
Danish: Der var desuden bedring i væksten hos alle de seks overlevende spædbørn.
English: In patients who have rapidly progressing disease before 6 months of age, a dose of 1 mg/kg is given once a week instead of once every other week; in these patients the dose can be increased to 3 mg/kg once a week depending on the response to treatment.
Danish: Hos patienter med hurtigt fremadskridende sygdom inden 6-måneders alderen gives en dosis på 1 mg/kg én gang ugentligt i stedet for én gang hver anden uge; hos sådanne patienter kan dosis sættes op til 3 mg/kg én gang ugentligt afhængigt af behandlingens virkning.
English: Kanuma should be started as early as possible after diagnosis and is intended for long-term use.
Danish: Behandlingen med Kanuma bør påbegyndes snarest muligt efter diagnosen, og lægemidlet er beregnet til langtidsbehandling.
English: These include chest discomfort, red eyes, eyelid swelling, difficulty breathing, itchy rash, hives, flushing, runny nose, rapid heartbeat and rapid breathing.
Danish: Disse består i ubehag i brystet, røde øjne, hævede øjenlåg, vejrtrækningsbesvær, kløende udslæt, nældefeber, rødme, løbende næse, hjertebanken og hurtig vejrtrækning.
English: Treatment should be given by a trained healthcare professional who can manage medical emergencies (such as a severe allergy).
Danish: Behandlingen bør gives af en erfaren sundhedsperson, der kan tage sig af akutte sygdomstilstande (såsom svær allergi).
English: The study showed that 6 out of the 9 infants given Kanuma survived to 1 year of age.
Danish: Undersøgelsen viste, at seks ud af ni spædbørn, der fik Kanuma, overlevede til 1-års-alderen.
English: It is not intended to provide practical advice on how to use Kanuma.
Danish: Det er ikke en praktisk vejledning i, hvordan Kanuma bør anvendes.
English: In this study, 31% of the patients given Kanuma (11 out of 36) achieved normal levels of ALT enzymes, compared with 7% of the patients given placebo (2 out of 30).
Danish: I denne undersøgelse opnåede 31 % af de patienter, der fik Kanuma (11 ud af 36) normale koncentrationer af enzymet ALT, sammenholdt med 7 % af dem, der fik placebo (2 ud af 30).
English: Because the number of patients with lysosomal acid lipase deficiency is low, the disease is considered ‘rare', and Kanuma was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 December 2010.
Danish: Da antallet af patienter med lysosomal sur lipase-mangel er lavt, betragtes sygdommen som "sjælden", og Kanuma blev udpeget som "lægemiddel til sjældne sygdomme" den 17. december 2010.
English: What are the risks associated with Kanuma?
Danish: Hvilke risici er der forbundet med Kanuma?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kanuma'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 Kanuma opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The first study involved 9 infants with growth failure or other evidence of rapidly progressing disease in their first 6 months of life.
Danish: Den første undersøgelse omfattede ni spædbørn med væksthæmning eller andre tegn på hurtigt fremadskridende sygdom i de første seks måneders levetid.
English: Development of antibodies against the medicine has also been reported especially in infants.
Danish: Der er indberettet om dannelse af antistoffer mod lægemidlet, navnlig hos spædbørn.
English: It must also not be used in patients with life-threatening allergy to eggs or any of Kanuma's ingredients.
Danish: Det må heller ikke anvendes hos patienter med livstruende allergi over for æg eller over for nogen af indholdsstofferne i Kanuma.
English: In addition, the company that markets Kanuma is carrying out a study in infants with rapidly progressing disease and will set-up a registry of patients of all ages to obtain further information on the long-term benefits and safety of Kanuma, in particular on the risk of allergic reactions and the development of antibodies against the medicine.
Danish: Desuden er den virksomhed, der markedsfører Kanuma, i færd med at udføre en undersøgelse hos spædbørn med hurtigt fremadskridende sygdom, og virksomheden vil oprette et register over patienter i alle aldre for at skaffe yderligere oplysninger om Kanumas fordele og sikkerhed på lang sigt, navnlig hvad angår risikoen for allergiske reaktioner og dannelse af antistoffer mod lægemidlet.
English: The full EPAR and risk management plan summary for Kanuma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Kanuma findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Kanuma contains the active substance sebelipase alfa.
Danish: Kanuma indeholder det aktive stof sebelipase alfa.
English: The CHMP considered that Kanuma led to significant improvements in survival in infants, and was effective at improving symptoms of the disease in patients of all ages.
Danish: CHMP fandt, at Kanuma væsentligt forbedrede overlevelsen hos spædbørn og gav effektiv bedring i symptomerne på sygdommen hos patienter i alle aldre.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Kanuma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Kanuma findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Kanuma must not be used in patients who have had a life-threatening allergic reaction to the active substance which re-occurred after stopping and starting treatment again.
Danish: Kanuma må ikke anvendes hos patienter, der har haft en livstruende allergisk reaktion over for det aktive stof, og hos hvem reaktionen vendte tilbage, når behandlingen blev genoptaget efter at have være standset.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kanuma, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Kanuma, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: High levels of ALT enzymes are a sign of liver damage.
Danish: Høj koncentration af enzymet ALT er et tegn på leverskade.
English: For more information about treatment with Kanuma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Kanuma, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Sebelipase alfa replaces the missing enzyme, helping to break down fats and stopping them building up in the body's cells.
Danish: Sebelipase alfa erstatter det manglende enzym, medvirker til at nedbryde fedtstoffer og standser ophobningen af dem i kroppens celler.
English: The Committee noted the lack of any effective treatments for lysosomal acid lipase deficiency and the high mortality in infants with rapidly progressing disease.
Danish: Udvalget bemærkede, at der savnes en effektiv behandling af lysosomal sur lipase-mangel, og at dødeligheden er høj hos spædbørn med hurtigt fremadskridende sygdom.
English: The main measure of effectiveness was the proportion of patients who achieved normal levels of a liver enzyme called ALT after 5 months of treatment.
Danish: Virkningen blev hovedsagelig bedømt på andelen af patienterne, der opnåede normal koncentration af leverenzymet ALT efter fem måneders behandling.
English: What benefits of Kanuma have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Kanuma?
English: Treatment with Kanuma should be supervised by a doctor experienced in the treatment of lysosomal acid lipase deficiency, other metabolic diseases or liver diseases.
Danish: Behandlingen med Kanuma bør overvåges af en læge med erfaring i behandling af lysosomal sur lipase-mangel, andre stofskiftesygdomme eller leversygdomme.
English: This is an inherited disease caused by the lack of an enzyme called lysosomal acid lipase, which is needed to break down fats within cells.
Danish: Denne arvelige sygdom skyldes mangel på enzymet lysosomal sur lipase, der er nødvendigt til at nedbryde fedtstofferne i cellerne.
English: How is Kanuma used?
Danish: Hvordan anvendes Kanuma?
English: The active substance in Kanuma, sebelipase alfa, is a copy of the enzyme that is lacking in patients with lysosomal acid lipase deficiency.
Danish: Det aktive stof i Kanuma, sebelipase alfa, er en kopi af det enzym, der mangler hos patienter med lysosomal sur lipase-mangel.
English: For the full list of all side effects reported with Kanuma, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Kanuma fremgår af indlægssedlen.
English: For practical information about using Kanuma, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Kanuma, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How does Kanuma work?
Danish: Hvordan virker Kanuma?
English: Kanuma has been studied in 2 main studies in patients with lysosomal acid lipase deficiency.
Danish: Kanuma er blevet undersøgt i to hovedundersøgelser hos patienter med lysosomal sur lipase-mangel.
English: Kanuma is a medicine used to treat patients of all ages with lysosomal acid lipase deficiency.
Danish: Kanuma er et lægemiddel til behandling af patienter i alle aldre med lysosomal sur lipase-mangel.
English: The company will also provide educational material to all doctors expected to prescribe Kanuma, encouraging them to enroll patients in the registry and informing them of how to monitor patients for antibodies and manage patients who develop severe allergic reactions.
Danish: Heri vil de blive opfordret til at optage patienter i registret, og de vil få information om, hvordan de skal overvåge patienterne for antistoffer og behandle patienter, som får alvorlige allergiske reaktioner
English: When the enzyme is absent or present only in low levels, fats accumulate in the body's cells, causing symptoms such as growth failure and liver damage.
Danish: Når dette enzym mangler eller kun findes i lav koncentration, ophober der sig fedtstoffer i kroppens celler.
English: Kanuma is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Danish: Kanuma fås som et koncentrat, der efter opløsning indgives med drop i en vene (koncentrat til infusionsvæske, opløsning).
English: The second study involved 66 patients (children and adults) and compared Kanuma with placebo (a dummy treatment).
Danish: Den anden undersøgelse omfattede 66 patienter (børn og voksne).
English: --1 Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of Streptococcus uberis, strain 5616 ............................................................................................................. ≥ 1 RPU* *Relative Potency Units (ELISA)
Danish: --1 Lipoteichoinsyre (LTA) fra biofilmadhæsionskomponent (BAC) fra Streptococcus uberis, stamme 5616
English: Cattle Intramuscular Vial (glass) 1 dose (2 ml)
Danish: Hætteglas 1 dosis (2 ml)
English: 20 vials
Danish: 0 dage
English: Before you start
Danish: Før du går i gang