FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients having received carmustine in childhood or adolescence, cases of extremely delayedonset pulmonary fibrosis (up to 17 years after treatment) have been described.
Danish: Hos patienter, der har fået carmustin i barndommen eller som unge, er der beskrevet tilfælde af ekstremt sent indsættende lungefibrose (op til 17 år efter behandlingen).
English: Pulmonary fibrosis (with fatal outcome), pulmonary infiltration
Danish: Pulmonal fibrose (med dødeligt udfald), pulmonal infiltration
English: Pulmonary toxicity also manifested in the post-marketing phase as pneumonitis and interstitial lung disease.
Danish: Den pulmonale toksicitet manifesterede sig i post-marketingfasen også som pneumonitis og interstitiel lungesygdom.
English: Therefore your doctor will monitor blood counts weekly for at least 6 weeks after a dose.
Danish: Din læge vil derfor overvåge blodtællingen en gang om ugen i mindst 6 uger efter en dosis.
English: This corresponds to 11.2 ml of beer or 4.65 ml wine, per dose.
Danish: Dette svarer til 11,2 ml øl eller 4,65 ml vin pr. dosis.
English: Myelosuppression is very common and begins 7-14 days of administration with recovery 4256 days of administration.
Danish: Myelosuppression er meget almindelig og begynder 7-14 dage efter administration, med restitution 42-56 dage efter administration.
English: During treatment, lung function tests (FVC, DLCO) should be performed regularly.
Danish: Under behandlingen bør der regelmæssigt foretages lungefunktionstests (FVC, DLCO).
English: The dry frozen product does not contain any preservatives and is suitable only for one use.
Danish: Det frysetørrede produkt indeholder ikke konserveringsstof og er kun egnet til engangsanvendelse.
English: Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed may not reflect the rates observed in clinical practice.
Danish: Da de kliniske undersøgelser er udført under meget specifikke betingelser, afspejler de observerede bivirkningsfrekvenser ikke nødvendigvis de hyppigheder, der ses i klinisk praksis.
English: The myelosuppression is dose and cumulative dose related, and often biphasic.
Danish: Myelosuppressionen er afhængig af dosis og kumulativ dosis, og er ofte bifasisk.
English: The intravenous solution is unstable in polyvinyl chloride containers.
Danish: Den intravenøse opløsning er ustabil i beholdere af polyvinylchlorid.
English: The kinetic of carmustine in humans is characterised by a two-chamber model.
Danish: Kinetikken af carmustin hos mennesker kan beskrives ved en to-compartment model.
English: Carmustine Obvius must be administered only by specialists experienced in the field of chemotherapy and under appropriate medical supervision
Danish: Carmustine Obvius må kun administreres af specialister i kemoterapi og under tilbørligt medicinsk opsyn
English: Powder: white to almost white powder or lyophilisate.
Danish: Pulver: hvidt til næsten hvidt pulver eller lyofilisat.
English: All patients younger than 5 years of age at the time of treatment died from pulmonary fibrosis; neither the carmustine dose nor an additional vincristine dose or spinal radiation had any influence on the fatal outcome.
Danish: der på behandlingstidspunktet var yngre end 5 år, døde af lungefibrose; hverken dosis af carmustin eller en supplerende vincristindosis eller spinal bestråling havde betydning for det dødelige udfald.
English: Interstitial fibrosis (with lower doses).
Danish: Interstitiel fibrose (ved lavere doser).
English: Carmustine Obvius has no or negligible influence on the ability to drive and use machines.
Danish: Carmustine Obvius påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Dermatitis with topical use improves with reduced concentration of compounded product, hyperpigmentation, transient, with accidental skin contact.
Danish: Dermatitis ved topikal anvendelse bedres ved nedsat koncentration af tilberedt produkt, hyperpigmentering, forbigående, ved accidentiel hudkontakt.
English: You must check with your doctor before driving or operating any tools or machines because the amount of alcohol in this medicine may impair your ability to drive or use machines.
Danish: Du skal kontakte din læge, før du fører motorkøretøj eller betjener værktøj eller maskiner, da mængden af alkohol i dette lægemiddel kan påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: It is unknown whether carmustine/metabolites are excreted in human milk.
Danish: Det er ukendt, om pentosanpolysulfatnatrium/metabolitter udskilles i human mælk.
English: If used during pregancy, the patient must be aware of the potential risk to the unborn baby.
Danish: Hvis det anvendes under graviditet, skal patienten være klar over den mulige risiko for det ufødte barn.
English: This information is a short description of preparation and/or handling, incompatibilities, posology of the medicine, overdose or monitoring measures and laboratory investigations based on the current SmPC.
Danish: Disse oplysninger er en kort beskrivelse af klargøring og/eller håndtering, uforligeligheder, lægemidlets dosering, foranstaltninger ved overdosering eller overvågning og laboratorieundersøgelser, baseret på det gældende produktresumé.
English: In cases where pulmonary toxicity started early (within 3 years of treatment), pulmonary infiltrates and/or pulmonary fibrosis occurred, some of which were fatal.
Danish: I tilfælde hvor den pulmonale toksicitet satte ind tidligt (inden for 3 års behandling) forekom der pulmonale infiltrater og/eller pulmonal fibrose, som i nogle tilfælde var dødelig.
English: When you are not clear about the fact whether the product is adequately cooled, then you should immediately inspect each and every vial in the carton.
Danish: Hvis det ikke er klart, om produktet er tilstrækkeligt afkølet, skal hvert eneste hætteglas i kartonen straks inspiceres.
English: Because of the good lipid solubility and the lack of ionisation at the physiological pH, carmustine is very well transferred through the blood-brain barrier.
Danish: Som følge af sin høje lipidopløselighed og manglende ionisering ved fysiologisk pH passerer carmustin meget let blod-hjernebarrieren.
English: Carmustine must be completely dissolved in ethanol before sterile water for injections is added.
Danish: Carmustin skal være fuldstændig opløst i ethanol, før der tilsættes sterilt vand til injektionsvæsker.
English: Administration of the infusion should be performed using a PVC free PE infusion set.
Danish: Administration af infusionen skal foretages med et PVC-frit PE-infusionssæt.
English: Dosage is based on your medical condition, body size and response to treatment.
Danish: Doseringen baseres på din helbredstilstand og legemsstørrelse, og hvordan du reagerer på behandlingen.
English: The 30 ml stock solution needs to be mixed thoroughly.
Danish: De 30 ml stamopløsning skal blandes omhyggeligt.
English: Common Hepatotoxicity, reversible, delayed up to 60 days after administration (high-dose therapy and dose-limiting), manifested by: - bilirubin, reversible increase - alkaline phosphatase, reversible increase - SGOT, reversible increase.
Danish: Hepatotoksicitet, reversibel, forsinket op til 60 dage efter administration (højdosisbehandling og dosisbegrænsende), manifesteret ved: - bilirubin, reversibel stigning - alkalisk fosfatase, reversibel stigning - ASAT, reversibel stigning.
English: In addition, the following serious adverse reactions may occur: liver necrosis, interstitial pneumonitis, encephalomyelitis.
Danish: Derudover kan der forekomme følgende alvorlige bivirkninger: levernekrose, interstitiel pneumonitis, encefalomyelitis.
English: Concomitant use with digoxin leads to delayed, moderate, suspected, decreased effect of digoxin (due to the decreased digoxin absorption).
Danish: Samtidig brug af digoxin medfører forsinket, moderat og formodentlig nedsat virkning af digoxin (som følge af nedsat digoxinabsorption).
English: Carmustine crosses the blood-brain barrier readily because of its lipophilic nature.
Danish: Carmustin krydser let blod-hjernebarrieren på grund af sin lipofile natur.
English: Pharmacotherapeutic group: Antineoplastic agents, alkylating agents, nitrosoureas, ATC code: L01AD01
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, alkyleringsmidler, nitrosoureastoffer; ATC-kode L01AD01
English: After reconstitution Carmustine Obvius is stable for 3 hours, stored in a glass container and protected from light.
Danish: Efter rekonstitution er Carmustine Obvius stabilt i 3 timer ved opbevaring i glasbeholder og beskyttet mod lys.
English: Solvent Clear type I glass ampoule (5 ml).
Danish: Solvens Klar glasampul type I (5 ml).
English: Renal toxicity Renal toxicity is rare, but occurs for cumulative doses < 1,000 mg/m2.
Danish: Renal toksicitet Renal toksicitet er sjælden, men forekommer ved kumulative doser <1 000 mg/m2
English: Pulmonary toxicity characterised by pulmonary infiltrates and/or fibrosis has been reported to occur with a frequency ranging up to 30%.
Danish: Pulmonal toksicitet kendetegnet af lungeinfiltrater og/eller -fibrose er beskrevet at forekomme med en hyppighed på op til 30 %.
English: In cases where the nadir after initial dose does not fall in the same row for leucocytes and platelets (e.g. leucocytes >4,000 and platelets <25,000) the value given the lowest percentage of prior dose should be used (e.g. platelets <25,000 then a maximum of 50% of prior dose should be given).
Danish: I tilfælde, hvor lavpunktet efter den indledende dosis ikke falder i samme række for leukocytter og blodplader (f.eks. leukocytter >4 000 og blodplader <25 000), bør der anvendes den værdi, der giver den laveste procentdel af den tidligere anvendte dosis, (hvis blodplader f.eks. <25 000, bør der højst gives 50 % af den tidligere dosis).
English: Carmustine Obvius must not be used in children and adolescents aged <18 years.
Danish: Carmustine Obvius må ikke anvendes børn eller unge <18 år.
English: The carbamoylating activity of carmustine is generally considered less significant than the alkylating activity in its action on tumors, but carbamoylation may serve to inhibit DNA repair.
Danish: Den carbamoylerende aktivitet af carmustin anses sædvanligvis for at have mindre betydning end den alkylerende aktivitet for dets virkning på tumorer, men carbamoylering kan tjene til at hæmme DNA-reparation.
English: However, opinion is divided over the role of the carbamoylating intermediates as mediators of the biological effects of the nitrosoureas.
Danish: Der er imidlertid delte meninger om de carbamoylerende mellemprodukters rolle som mediatorer af nitrosoureastoffernes biologiske virkninger.
English: Patients with a baseline below 70% of the predicted forced vital capacity (FVC) or carbon monoxide diffusing capacity (DLCO) are particularly at risk.
Danish: Patienter med en baselineværdi på under 70 % af den forventede tvungne vitalkapacitet (FVC) eller carbonmonoxid-diffusionsevne (DLCO) har særlig risiko.
English: What you need to know before you use Carmustine Obvius Do not use Carmustine Obvius:
Danish: Det skal du vide, før du begynder at bruge Carmustine Obvius Brug ikke Carmustine Obvius:
English: Carmustine Obvius contains ethanol (alcohol)
Danish: Carmustine Obvius indeholder alkohol (ethanol)
English: Leucocytes/mm3
Danish: Leukocytter/mm3
English: When Carmustine Obvius is used in combination with other myelosuppressive medicinal products or in patients in whom bone marrow reserve is depleted, the doses should be adjusted according to the haematologic profile of the patient as shown below.
Danish: Når Carmustine Obvius anvendes i kombination med andre myelosuppressive lægemidler eller hos patienter, hvis knoglemarvsreserve er depleteret, bør doserne justeres i henhold til patientens hæmatologiske profil som vist nedenfor.
English: As an alkylating agent, it can alkylate reactive sites on nucleoproteins, thus interfering with DNA and RNA synthesis and DNA repair.
Danish: Som et alkylerende middel kan det alkylere reaktive steder på nukleoproteiner og således interferere med DNA- og RNA-syntesen og DNAreparation.
English: Direct administration of carmustine into the carotid artery is regarded as experimental and has been associated with ocular toxicity.
Danish: Administration af carmustin direkte i arteria carotis anses for eksperimentel og er blevet sat i forbindelse med okulær toksicitet.
English: When placebo-controlled trials are available, adverse reactions are included if the incidence is ≥ 5% higher in the treatment group.
Danish: Når der foreligger placebokontrollerede forsøg, medtages bivirkninger, hvis hyppighed er ≥ 5 % højere i behandlingsgruppen.
English: Repeat doses of Carmustine Obvius should not to be given more frequently than every six weeks.
Danish: Doseringen med Carmustine Obvius bør ikke gentages hyppigere end hver sjette uge.
English: Common Alopecia, flushing (due to alcohol content of solvent; increased with administration times <1-2 h), injection site reaction.
Danish: Alopeci, rødme (som følge af alkoholindholdet i solvenset; øget ved administrationstid <1-2 timer), reaktion på injektionsstedet.
English: Carmustine and related nitrosoureas are unstable in aqueous solutions and degrade spontaneously to reactive intermediates that are capable of alkylation and carbamoylation.
Danish: Carmustin og beslægtede nitrosoureastoffer er ustabile i vandig opløsning og nedbrydes spontant til reaktive mellemprodukter, der er i stand til at alkylere og carbamylere.
English: Since the use of Carmustine Obvius can lead to lung damage, an X-ray of the chest region and lung function tests will be conducted before treatment is started (please also see the section “Possible side effects”).
Danish: Da brug af Carmustine Obvius kan medføre lungeskade, vil der blive taget et røntgenbillede af brystkassen og foretaget lungefunktionstests før påbegyndelse af behandlingen (se også afsnittet "Bivirkninger").
English: Carmustine should not be administered to patients who are pregnant.
Danish: Carmustin bør ikke administreres til gravide patienter.
English: Blood counts should be monitored frequently and repeat courses should not be given before six weeks because of delayed haematologic toxicity.
Danish: Der bør hyppigt foretages blodtælling, og nye behandlingsforløb bør først gives efter seks uger på grund af forsinket hæmatologisk toksicitet.
English: The recommended dose of Carmustine Obvius as a single agent in previously untreated patients is 150 to 200 mg/m2 intravenously every 6 weeks.
Danish: Den anbefalede dosis Carmustine Obvius som eneste behandling hos tidligere ubehandlede patienter er 150 til 200 mg/m2 intravenøst hver 6. uge.
English: In addition, carmustine is known to carbamoylate lysine residues on proteins causing irreversible inactivation of enzymes including glutathione reductase.
Danish: Derudover vides carmustin at bevirke carbamoylering af lysinrester på proteiner, hvilket forårsager irreversibel inaktivering af enzymer, herunder glutathionreduktase.
English: To be taken into account in pregnant or breast-feeding women, children and highrisk groups such as patients with liver disease, or epilepsy.
Danish: Dette skal tages i betragtning hos kvinder, der er gravide eller ammer, samt hos børn og højrisikogrupper, såsom patienter med leversygdom eller epilepsi.
English: Method of administration Carmustine Obvius is for intravenous use after reconstitution and further dilution.
Danish: Administration Carmustine Obvius er til intravenøs anvendelse efter rekonstitution og yderligere fortynding.
English: The alkylating intermediates are believed to be responsible for the antitumor effect of carmustine.
Danish: De alkylerende mellemprodukter menes at være ansvarlige for carmustins antitumorvirkning.
English: Posology and laboratory investigations
Danish: Dosering og laboratorieundersøgelser
English: Each ampoule of solvent contains 3 ml ethanol anhydrous (that is equivalent to 2.37 g).
Danish: Hver ampul med solvens indeholder 3 ml ethanol, vandfri (svarende til 2,37 g).
English: Talk to your doctor, pharmacist or nurse before using Carmustine Obvius.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Carmustine Obvius,
English: The major side effect of this medicine is delayed bone marrow suppression, which may show as tiredness, bleeding from the skin and mucous membranes as well as infections and fever due to changes in the blood.
Danish: Den vigtigste bivirkning af dette lægemiddel er forsinket knoglemarvsundertrykkelse, som kan vise sig som træthed, blødning fra huden og slimhinderne samt infektioner og feber som følge af ændringer i blodet.
English: Common Anorexia, constipation, diarrhoea, stomatitis.
Danish: Anoreksi, konstipation, diarré, stomatitis.
English: Carmustine Obvius is a medicine which contains carmustine.
Danish: Carmustine Obvius er et lægemiddel, der indeholder carmustin.
English: Intravenously administered carmustine is rapidly degraded, with no substance intact detectable after 15 minutes.
Danish: Efter intravenøs administration nedbrydes carmustin hurtigt, så der ikke kan detekteres intakt stof efter 15 minutter.
English: The antineoplastic and toxic activities of carmustine may be due to its metabolites.
Danish: Den antineoplastiske og toksiske aktivitet af carmustin kan skyldes dets metabolitter.
English: This medicine contains 0.57 vol% ethanol (alcohol), which means 7.62 g per dose.
Danish: Dette lægemiddel indeholder 0,57 vol % alkohol (ethanol), dvs. 7,62 g pr. dosis.
English: Carmustine Obvius is contraindicated during breastfeeding and up to seven days post-treatment (see section 4.3).
Danish: Carmustine Obvius er kontraindiceret under amning og i op til syv dage efter behandlingen (se pkt.
English: 3 years.
Danish: 6. uge.
English: The bone marrow toxicity of carmustine is cumulative and therefore the dosage adjustment must be considered on the basis of nadir blood counts from prior doses (see section
Danish: Knoglemarvstoksiciteten af carmustin er kumulativ, hvorfor der skal tages stilling til dosisjustering på basis af lavpunktet af blodtælling ved forudgående doser (se pkt.
English: Carmustine is a cell-cycle phase nonspecific antineoplastic agent of the nitrosourea type, which exerts tumor cytotoxicity via multiple mechanisms.
Danish: Carmustin er et cellecyklusfase-uspecifikt antineoplastisk middel af nitrosoureastof-typen, som udøver tumorcytotoksicitet via flere mekanismer.
English: A repeat course of Carmustine Obvius should not be given until circulating blood elements have returned to acceptable levels (platelets above 100,000/mm3, leukocytes above 4,000/mm3), and this is usually in six weeks.
Danish: Der bør ikke gives en ny cyklus af Carmustine Obvius, før de cirkulerende blodelementer igen har et acceptabelt niveau (blodplader over 100 000/mm3, leukocytter over 4 000/mm3), og det er sædvanligvis i løbet af seks uger.
English: Complete blood count should be monitored frequently for at least six weeks after a dose.
Danish: Komplet blodtælling bør foretages hyppigt i mindst seks uger efter en dosis.
English: Pulmonary toxicity, interstitial fibrosis (with prolonged therapy and cumulative dose)
Danish: Pulmonal toksicitet, interstitiel fibrose (ved langtidsbehandling og ved kumulativ dosis)
English: There are no limits for the period of application of carmustine therapy.
Danish: Der er ingen begrænsninger for varigheden af behandlingen med carmustin.
English: By reconstituting the powder with the solvent provided, a solution has to be prepared by adding additional 27 ml water for injections.
Danish: Ved at rekonstituere pulveret med solvensen skal der fremstilles en opløsning, idet der tilsættes yderligere 27 ml vand til injektionsvæsker.
English: Pneumonitis is seen for doses >450 mg/m2 and interstitial lung disease is seen with prolonged therapy and cumulative dose > 1,400 mg/m2.
Danish: Pneumonitis ses for doser >450 mg/m2, og interstitiel lungesygdom ses ved langvarig behandling og kumulativ dosis >1 400 mg/m2
English: During administration of the medicinal product, the container shall be of suitable glass ware.
Danish: Til administration af lægemidlet anvendes en passende beholder af glas.
English: Nausea and vomiting are severe and begins within 2-4 h of administration and lasts for 4-6 h.
Danish: Kvalme og opkastning er af svær grad, begynder inden for 2-4 timer af administration og varer i 4-6 timer.
English: Not known Infertility, teratogenesis.
Danish: Infertilitet, teratogenese.
English: Solvent: colourless clear liquid.
Danish: Solvens: klar, farveløs væske.
English: Guidelines for the safe handling and disposal of antineoplastic agents must be observed.
Danish: Retningslinjer for sikker håndtering og bortskaffelse af antineoplastiske midler skal overholdes.
English: After reconstitution and dilution
Danish: Efter rekonstitution og fortynding
English: The powder is white to almost white powder supplied in a brown glass vial.
Danish: Pulveret er et hvidt til næsten hvidt pulver, der leveres i et brunt hætteglas.
English: Common Acute leukaemia, bone marrow dysplasia - following long-term use.
Danish: Akut leukæmi, knoglemarvsdysplasi - efter langvarig anvendelse.
English: Not known (frequency cannot be estimated from the available data) - Muscular pain; - Seizures (fits) including status epilepticus; - Tissue damage due to leakage in injection area; - Infertility; - Carmustine has been shown to adversely affect the development of unborn babies
Danish: Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data) - Muskelsmerter - Anfald, herunder status epilepticus - Vævsbeskadigelse som følge af udsivning i injektionsområdet - Infertilitet - Carmustin er påvist at påvirke udviklingen af det ufødte barn negativt
English: In case the tumor remains incurable or some serious or intolerable adverse reactions appear, the carmustine therapy must be terminated.
Danish: Hvis tumoren viser sig at være uhelbredelig, eller der opstår alvorlige eller uacceptable bivirkninger, skal carmustin seponeres.
English: For patients with renal impairment the dose of Carmustine Obvius should be reduced if the glomerular filtration rate is reduced.
Danish: For patienter med nedsat nyrefunktion bør dosis af Carmustine Obvius reduceres, hvis den glomerulære filtreringshastighed er reduceret.
English: Common Encephalopathy (high-dose therapy and dose-limiting).
Danish: Encefalopati (højdosisbehandling og dosisbegrænsende).
English: At the recommended dosage, courses of Carmustine Obvius would not be given more frequently than every 6 weeks.
Danish: Ved den anbefalede dosering gives der ikke behandlingsforløb med Carmustine Obvius oftere end hver 6. uge.
English: The solution should be protected from light until end of administration.
Danish: Opløsningen bør beskyttes mod lys, indtil indgivelsen er afsluttet.
English: This medicinal product contains 0.57 vol% ethanol (alcohol), i.e. up to 7.62 g per dose, equivalent to 11.2 ml beer or 4.65 ml wine per dose.
Danish: Dette lægemiddel indeholder 0,57 vol % ethanol (alkohol), dvs. op til 7,62 g pr. dosis, svarende til 11,2 ml øl eller 4,65 ml vin pr. dosis.
English: The amount of alcohol in this medicinal product may alter the effects of other medicines, and may impair your ability to drive or use machines.
Danish: Mængden af alkohol i dette lægemiddel kan ændre virkningerne af andre lægemidler og kan påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: Patients showing a baseline value of <70% of expected forced vital capacity or carbon monoxide diffusion capacity in these tests are at particular risk.
Danish: Risikoen gælder navnlig patienter med en baselineværdi på <70 % af den forventede tvungne vitalkapacitet eller carbonmonoxiddiffusionskapacitet i disse tests.
English: Nadir after prior dose
Danish: Lavpunkt efter forudgående dosis
English: Rare (may affect up to 1 in 1,000 people) - Veno-occlusive disease (progressive blockage of the veins) where very small (microscopic) veins in the liver are blocked.
Danish: Sjælden (kan forekomme hos 1 ud af 1 000 behandlede): - Venookklusiv sygdom (tiltagende blokering af venerne), hvor meget små (mikroskopiske) vener i leveren blokeres.