FrancophonIA/ELRC3.0 huggingface dataset:
English: Biotransformation It is presumed that the metabolites of carmustine cause its antineoplastic and toxic activity.
Danish: Biotransformation Carmustins metabolitter formodes at være årsag til dets antineoplastiske og toksiske aktivitet.
English: The reconstituted and diluted solution (i.e. ready-to-use solution) must be given intravenously and should be administered by intravenous drip over a one- to two-hour period and administration should be finalised within 3 hours from reconstitution/dilution of the medicinal product.
Danish: Den rekonstituerede og fortyndede opløsning (dvs. den brugsklare opløsning) skal gives intravenøst og administreres ved intravenøst drop i løbet af 1-2 timer, og administrationen skal være afsluttet inden for 3 timer fra rekonstitution/fortynding af lægemidlet.
English: The 530 ml diluted solution (i.e. the ready-to-use solution) should be mixed for at least 10 seconds before administration.
Danish: De 530 ml fortyndet opløsning (dvs. den brugsklare opløsning) blandes i mindst 10 sekunder før administration.
English: Reconstitution, as recommended, results in a clear, colourless to light yellow stock solution.
Danish: Ved rekonstitution som anbefalet fås en klar, farveløs til gullig stamopløsning.
English: All plastic coming into contact with the carmustine solution for infusion (e.g. infusion set etc.) should be PVC free polyethylene plastic, otherwise glass ware should be used.
Danish: Al plast, der kommer i kontakt med carmustin infusionsvæske, opløsning (f.eks. infusionssæt mv.), bør være PVC-fri polyethylenplast, ellers bør der anvendes glas.
English: The Ready-to-Use solution should be administered over 1-2 hours and administration should be finalised within 3 hours from reconstitution of the product.
Danish: Den brugsklare opløsning bør administreres i løbet af 1-2 timer, og administrationen bør være afsluttet senest 3 timer efter rekonstitution af produktet.
English: In case of a decreased number of circulating platelets, leucocytes or erythrocytes either from previous chemotherapy or other cause the dose should be adjusted, see Table 1, section 4.2.
Danish: Ved nedsat antal blodplader, leukocytter eller erytrocytter i kredsløbet, enten som resultat af tidligere kemoterapi eller af anden årsag, bør dosis justeres, se tabel 1, pkt.
English: Carmustine is carcinogenic in rats and mice at doses less than the recommended human dose based on body surface area.
Danish: Carmustin er karcinogent hos rotter og mus i doser, der er mindre end den anbefalede humane dosis baseret på legemsoverflade.
English: Baseline pulmonary function studies and chest X-ray should be conducted along with frequent pulmonary function tests during treatment.
Danish: Ved baseline bør der foretages undersøgelse af lungefunktion og røntgen af thorax, og under behandlingen hyppige lungefunktionstests.
English: Guidelines for the safe disposal of antineoplastic agents must be observed.
Danish: Retningslinjer for sikker bortskaffelse af antineoplastiske midler skal overholdes.
English: The duration of infusion should not be less than one hour to avoid burning and pain at the injected area.
Danish: Infusionens varighed bør ikke være mindre end én time for at undgå brændende fornemmelse og smerter på det injicerede område.
English: Carmustine, at clinically relevant dose levels, was carcinogenic in rats and mice.
Danish: Carmustin var ved klinisk relevante dosisniveauer karcinogent hos rotter og mus.
English: For storage conditions after reconstitution and further dilution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution og yderligere fortynding af lægemidlet, se pkt.
English: The lyophilisate can appear as a fine powder, however handling can cause it to appear as a more heavy and lumpy lyophilisate than as a powdery lyophilisate due to the mechanical instability of the freeze drying cake.
Danish: Lyofilisatet kan fremstå som et fint pulver, men håndtering kan få det til at fremstå som et mere tungt, klumpet lyofilisat end som et pulverformigt lyofilisat, hvilket skyldes den mekaniske ustabilitet af det frysetørrede kompakte pulver.
English: Contents of the pack and other information What Carmustine Obvius contains
Danish: Pakningsstørrelser og yderligere oplysninger Carmustine Obvius indeholder:
English: This may occur within 3 years of therapy and appears to be dose related with cumulative doses of 1,200-1,500 mg/m2 being associated with increased likelihood of lung fibrosis.
Danish: Dette kan forekomme inden for 3 års behandling og synes at være dosisrelateret, idet kumulative doser på 1 200-1 500 mg/m2 er forbundet med forhøjet sandsynlighed for lungefibrose.
English: Adverse reactions are generally included if they were reported in more than 1% of patients in the product monograph or pivotal trials,
Danish: Generelt er der medtaget bivirkninger, der er rapporteret hos mere end 1 % af patienterne i studierne vedrørende produktmonografien eller i de pivotale studier og/eller er udpeget som klinisk vigtige.
English: For verification, hold the vial in bright light.
Danish: Til verifikation heraf holdes hætteglasset i kraftigt lys.
English: Not known Muscular pain, status epilepticus, seizure, grand mal seizure.
Danish: Muskelsmerter, status epilepticus, krampeanfald, grand mal anfald.
English: Concomitant use with cimetidine leads to delayed, major, suspected, increased carmustine toxic effect (due to the inhibition of carmustine metabolism).
Danish: Samtidig brug af cimetidin fører til forsinket, kraftig og formodentlig toksisk virkning af carmustin (som følge af hæmningen af metaboliseringen af carmustin).
English: Obvius Investment B.V. De Cuserstraat 93
Danish: De Cuserstraat 93
English: it has been speculated that the carbamoylating species may mediate some of toxic effects of carmustine.
Danish: På den anden side er det blevet foreslået, at den carbamoylerende beskaffenhed kan mediere nogle af de toksiske virkninger af carmustin.
English: Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body), and feeling you are going to faint.
Danish: Pludseligt vejrtrækningsbesvær, hævelse af øjenlåg, ansigt eller læber, udslæt eller kløe (især hvis det er over hele kroppen), og fornemmelse af at være tæt på at besvime.
English: This can result in increased liver enzymes and bilirubin (detected by blood tests); - Alopecia (loss of hair); - Flushing of the skin; - Reactions on the injection site
Danish: Dette kan medføre forhøjelse af leverenzymer og bilirubin (bestemt ved blodprøver) - Hårtab (alopeci) - Rødme af huden - Reaktioner på injektionsstedet
English: Emetogenic potential The emetogenic potential is high at doses >250 mg/m2 and high to moderate in doses
Danish: Emetogent potentiale Det emetogene potentiale er højt i doser >250 mg/m2 og højt til moderat i doser ≤250 mg/m2.
English: Male patients should use adequate contraceptive measures while on treatment with Carmustine Obvius and for at least 6 months after treatment to prevent their partners becoming pregnant.
Danish: Mandlige patienter bør anvende passende prævention, mens de er i behandling med Carmustine Obvius og i mindst 6 måneder efter behandlingen for at undgå, at deres partner bliver gravid.
English: The injected area will be monitored during the administration.
Danish: Det injicerede område vil blive overvåget under indgiften.
English: EXP After reconstitution/dilution: See package leaflet for the shelf life of the reconstituted medicine.
Danish: Efter rekonstitution/fortynding: Se indlægssedlen vedrørende holdbarheden af det rekonstituerede lægemiddel.
English: The resulting ready-to-use solution for infusion should then be administered immediately by intravenous drip over a one- to two-hour period protected from light.
Danish: Den resulterende brugsklare infusionsvæske, opløsning, bør derefter administreres straks med intravenøst drop i løbet af en periode på 1-2 timer, beskyttet mod lys.
English: The solvent is a colourless clear liquid supplied in a clear glass ampule.
Danish: Opløsningsmidlet er en farveløs, klar væske, der leveres i en glasampul.
English: Ataxia, dizziness, headache.
Danish: Ataksi, svimmelhed, hovedpine.
English: Carmustine belongs to a group of anticancer medicines known as nitrosourea that act by slowing the growth of cancer cells.
Danish: Carmustin er et kræftlægemiddel i gruppen nitrosourinstoffer, der virker ved at bremse kræftcellers vækst.
English: If Carmustine Obvius is used during pregnancy, or if the patient becomes pregnant while taking (receiving) Carmustine Obvius, the patient should be apprised of the potential hazard to the foetus.
Danish: Hvis Carmustine obvius anvendes under graviditet, eller hvis patienten bliver gravid under behandlingen, bør patienten advares om den mulige risiko for barnet.
English: Severe (end-stage) renal impairment.
Danish: Svær (terminal) nyrefunktionsnedsættelse
English: On one hand, their carbamoylating activity was reported to contribute to the cytotoxic properties of their parent drugs by inhibiting DNA repair enzymes.
Danish: På den ene side er deres carbamylerende aktivitet beskrevet at bidrage til moderstoffernes cytotoksiske egenskaber ved at hæmme enzymer til
English: Keep the vial and ampoule in the outer carton in order to protect from light.
Danish: Opbevar hætteglasset og ampullen i den ydre karton for at beskytte mod lys.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness:
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Risk factors include smoking, respiratory disease, existing radiographic abnormalities, sequential or concomitant thoracic radiation, as well as combination with other active substances that can cause lung damage.
Danish: Risikofaktorer omfatter rygning, luftvejssygdom, eksisterende radiografiske abnormiteter, sekventiel eller samtidig bestråling af thorax samt kombination med andre aktive stoffer, der kan forårsage lungebeskadigelse.
English: Veno-occlusive disease (high-dose therapy).
Danish: Veno-okklusiv sygdom (højdosisbehandling).
English: Brown type I hydrolytic glass vial (50 ml) with light grey 20 mm bromobutyl rubber stopper and sealed with a dark red aluminium flip-off cap.
Danish: Brunt hætteglas af glas af hydrolysetype I (50 ml) med lysegrå 20 mm prop af brombutylgummi forseglet med en mørkerød afrivningskapsel af aluminium.
English: - Secondary therapy in non-Hodgkin's lymphoma and Hodgkin's disease
Danish: - Non-Hodgkins lymfom og Hodgkins sygdom som sekundær behandling
English: Ocular toxicities, transient conjunctival flushing and blurred vision due to retinal haemorrhages.
Danish: Okulær toksicitet, forbigående rødme af konjunktiva og sløret syn som følge af retinal blødning.
English: The incidence of adverse reactions is probably doserelated; cumulative doses of 1200-1500 mg/m2 have been associated with an increased likelihood of pulmonary fibrosis.
Danish: Incidensen af bivirkninger er sandsynligvis dosisrelateret; kumulative doser på 1 200-1 500 mg/m2 er sat i forbindelse med øget sandsynlighed for pulmonal fibrose.
English: Carmustine may impair male fertility.
Danish: Carmustin kan nedsætte den mandlige fertilitet.
English: Further, the ready-to-use solutions needs to be protected from light (e.g. using alu-foil wrapped around the container of the Ready-to-Use solution) and preferably kept at temperatures below 20-22°C as carmustine degrades faster at higher temperatures.
Danish: Desuden skal den brugsklare opløsning beskyttes mod lys (f.eks. at vikle alufolie omkring beholderen med brugsklar opløsning) og opbevares ved temperaturer fortrinsvis under 20-22 °C, da carmustin nedbrydes hurtigere ved højere temperatur.
English: Other medicines and Carmustine Obvius
Danish: Brug af anden medicin sammen med Carmustine Obvius
English: Paediatric population Carmustine must not be used in children aged <18 years because of safety concerns.
Danish: Carmustin må ikke anvendes hos børn under 18 år på grund af betænkeligheder vedrørende sikkerheden.
English: Secondary therapy in non-Hodgkin's lymphoma and Hodgkin's disease
Danish: Non-Hodgkins lymfom og Hodgkins sygdom som sekundær behandling
English: Bone marrow toxicity is a common and severe toxic adverse reaction of carmustine.
Danish: Knoglemarvstoksicitet er en almindelig, svær toksisk bivirkning af carmustin.
English: Hypersensitivity to the active substance, to other nitrosoureas or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, andre nitrosourinstoffer eller et eller flere af hjælpestofferne anført i pkt.
English: Carmustine is effective in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery):
Danish: Carmustin er effektivt som eneste middel eller i kombination med andre antineoplastiske midler og/eller andre behandlingstiltag (radioterapi, kirurgi) til behandling af følgende maligne neoplasmer:
English: The duration of infusion should not be less than one hour, otherwise it leads to burning and pain in the injected area.
Danish: Infusionsvarigheden bør ikke være mindre end én time, da infusionen ellers medfører brændende fornemmelse og smerter i det injicerede område.
English: - The active substance is carmustine.
Danish: - Aktivt stof: carmustin.
English: However, the possibility will have to be taken into consideration, that the alcohol quantity in these pharmaceutical medicines can impair the ability to drive and use machines.
Danish: Dog må der tages hensyn til, at alkoholindholdet i disse lægemidler kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: - Brain tumours (glioblastoma, Brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases
Danish: - Hjernesvulster (glioblastom, hjernestamme-gliom, medulloblastom, astrocytom og ependymom), hjernemetastaser
English: Women of childbearing potential/contraception in males and females Women should use effective contraception to avoid becoming pregnant while on treatment and for at least 6 months after treatment.
Danish: Kvinder i den fødedygtige alder/antikonception til mænd og kvinder Kvinder bør anvende effektiv prævention for at undgå at blive gravide under behandlingen og i mindst 6 måneder efter behandlingen.
English: Infusion of Carmustine Obvius over shorter periods of time may produce intense pain and burning at the site of injection.
Danish: Hvis Carmustine Obvius infunderes i løbet af kortere tid, kan det medføre intensiv smerte og brændende fornemmelse på injektionsstedet.
English: Paediatric population Carmustine is contraindicated in children and adolescents aged <18 years (see section 4.3)
Danish: Pædiatrisk population Carmustin er kontraindiceret hos børn og unge <18 år (se pkt.
English: Hepatic and renal function should also be checked prior to treatment and regularly monitored during therapy (see section 4.8).
Danish: Lever- og nyrefunktion bør ligeledes kontrolleres før behandling og overvåges regelmæssigt under behandlingen (se pkt.
English: Brain tumours (glioblastoma, Brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases
Danish: Hjernesvulster (glioblastom, hjernestamme-gliom, medulloblastom, astrocytom og ependymom), hjernemetastaser
English: Not known Extravasation hazard: vesicant
Danish: Risiko ved ekstravasation: blæredannende
English: Carmustine was embryotoxic and teratogenic in rats and embryotoxic in rabbits at dose levels equivalent to the human dose.
Danish: Carmustin var embryotoksisk og teratogent hos rotter og embryotoksisk hos kaniner ved dosisniveauer ækvivalente med den humane dosis.
English: if you suffer from suppression of blood cell formation in the bone marrow and the number of your platelets, white blood cells (leucocytes), or red blood cells (erythrocytes) is therefore reduced, either as a result of chemotherapy or other causes.
Danish: hvis du er allergisk over for carmustin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6) hvis du har nedsat dannelse af blodceller i knoglemarven, og antallet af blodplader, hvide blodlegemer (leukocytter) eller røde blodlegemer (erythrocytter) derfor er nedsat, enten som følge af kemoterapi eller af andre årsager.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen refererer til den sidste dag i den nævnte måned.
English: Before treatment, your liver, lung and kidney function will be tested and observed regularly during treatment.
Danish: Din lever-, lunge- og nyrefunktion vil blive testet før behandlingen og vil regelmæssigt blive observeret under behandlingen.
English: After reconstitution and dilution, one mL of solution contains 3.3 mg carmustine.
Danish: Efter rekonstitution og fortynding indeholder én ml opløsning 3,3 mg carmustin.
English: Following reconstitution and dilution Carmustine Obvius is given into a vein by a drip (intravenously) over a one- to two-hour period protected from light.
Danish: Efter rekonstitution og fortynding indgives Carmustine Obvius i en vene med drop (intravenøst) i løbet af 1-2 timer, beskyttet mod lys.
English: Then aseptically add 27 ml of sterile water for injections to the alcohol solution.
Danish: Derefter tilsættes aseptisk 27 ml sterilt vand til injektionsvæsker til den alkoholiske opløsning.
English: Doses subsequent to the initial dose should be adjusted according to the haematologic response of the patient to the preceding dose, in both monotherapy as well as in combination therapy with other myelosuppressive medicinal products.
Danish: Doser efter initialdosis bør justeres i henhold til patientens hæmatologiske respons på den foregående dosis, både ved monoterapi og ved kombinationsbehandling med andre myelosuppressive lægemidler.
English: Women of childbearing potential are advised to use effective contraception to avoid becoming pregnant whilst being treated with this medicine and for at least 6 months after treatment.
Danish: Kvinder i den fødedygtige alder rådes til at anvende effektiv prævention, så de undgår at blive gravide, mens de er i behandling med dette lægemiddel og i mindst 6 måneder efter behandlingen.
English: How to use Carmustine Obvius
Danish: Sådan skal du bruge Carmustine Obvius
English: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dose range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or therapy with other medicinal products.
Danish: Generelt bør der udvises forsigtighed ved valg af dosis til ældre, og der bør sædvanligvis begyndes i den lave ende af dosisområdet som afspejling af den større hyppighed af nedsat lever-, nyre- eller hjertefunktion og af samtidig sygdom eller behandling med andre lægemidler.
English: The following table includes adverse reactions of carmustine listed by MedDRA system organ class and frequency convention presented in order of decreasing seriousness: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to < 1/1,000); very rare (<1/10,000), not known (frequency cannot be estimated from the available data).
Danish: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1 000 til <1/100),
English: Symptoms may include: fluid accumulation in the abdomen, enlargement of spleen, severe bleeding of the oesophgus, yellow-coulouring of skin and whites of the eyes; - Breathing problems caused by interstitial fibrosis (with lower doses); - Kidney problems; - Gynecomastia (breast growth in males)
Danish: Symptomerne kan omfatte: Væskeophobning i maven, forstørret milt, alvorlige blødning i spiserøret, gulfarvning af huden eller det hvide i øjnene - Vejrtrækningsproblemer som følge af interstitiel fibrose (ved lavere doser) - Nyreproblemer - Gynækomasti (vækst af bryster hos mænd)
English: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and the glomerular filtration rate should be monitored and the dose reduced according to this.
Danish: Da ældre patienter har større sandsynlighed for at have nedsat nyrefunktion, bør der udvises forsigtighed ved valg af dosis, og den glomerulære filtreringshastighed bør overvåges, og dosis reduceres i overensstemmelse dermed.
English: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and the glomerular filtration rate should be monitored and dose reduced according to this.
Danish: Da ældre patienter har større sandsynlighed for at have nedsat nyrefunktion, bør der udvises forsigtighed ved valg af dosis, og den glomerulære filtreringshastighed bør overvåges og dosis reduceres i overensstemmelse hermed.
English: Pregnancy and fertility
Danish: Graviditet og frugtbarhed
English: Dexamethasone, used as an anti-inflammatory and immunosuppressive agent Cimetidine, used for stomach problems like indigestion Digoxin, used if you have abnormal heart rhythm Melphalan, an anticancer medicine
Danish: Dette gælder også medicin, som ikke er købt på recept så som: phenytoin, mod epilepsi dexamethason, der anvendes som antiinflammatorisk og immunundertrykkende middel cimetidin, der anvendes mod maveproblemer såsom fordøjelsesbesvær digoxin, der anvendes, hvis du har unormal hjerterytme melphalan, der er et kræftmiddel
English: Solvent for Carmustine Obvius ethanol anhydrous IV
Danish: Solvens til Carmustine Obvius ethanol, vandfri i.v.
English: Reconstitution and dilution of the powder for concentrate for solution for infusion Dissolve the Carmustine (100 mg powder) 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 carmustin (100 mg pulver) med 3 ml af det medfølgende sterile, nedkølede ethanolsolvens i den primære emballage (det brune hætteglas).
English: Carmustine is embryotoxic in rats and rabbits and teratogenic in rats when given in doses equivalent to the human dose.
Danish: Carmustin er embryotoksisk hos rotter og kaniner og teratogent hos rotter i doser ækvivalente med den humane dosis.
English: Liver, kidney and lung function should be checked and monitored regularly during therapy (see section 4.8).
Danish: Lever-, nyre- og lungefunktion bør kontrolleres og overvåges regelmæssigt under behandlingen (se pkt.
English: Then aseptically add 27 ml of sterile water for injection to the alcohol solution.
Danish: Derefter tilsættes aseptisk 27 ml sterilt vand til den alkoholiske opløsning.
English: Male patients should be advised to use adequate contraceptive measures while on treatment with carmustine and for at least 6 months after treatment.
Danish: Mandlige patienter bør tilrådes at anvende tilstrækkelig prævention under behandlingen med carmustin og i mindst 6 måneder efter behandlingen.
English: As a doctor or nurse will be giving you this medicine, it is unlikely that you will receive an incorrect dose.
Danish: Det er derfor ikke sandsynligt, at du får en forkert dosis.
English: Common (may affect up to 1 in 10 people) - Acute leukaemias and bone marrow dysplasias (abnormal development of the bone marrow).Symptoms may include bleeding from the gums, bone pain, fever, frequent infections, frequent or severe nosebleed, lumps caused by swollen lymph nodes in and around the neck, underarm, abdomen or groin, pale skin, shortness of breath, weakness, fatigue or a general decrease in energy; - Anaemia (decrease in the amount of red blood cells in the blood); - Encephalopathy (disorder of brain).
Danish: Symptomerne kan omfatte blødning fra tandkødet, knoglesmerter, feber, hyppige infektioner, hyppige eller svære næseblødninger, knuder forårsaget af hævede lymfeknuder i og omkring nakken, underarme, mave eller lyske, bleg hud, kortåndethed, svækkelse, træthed eller nedsat energiniveau i almindelighed - Anæmi (nedsat antal røde blodlegemer i blodet)