FrancophonIA/ELRC3.0 huggingface dataset:
English: You will usually inject two doses of 0.5 mL in a day, unless your doctor has prescribed a lower dose for you.
Danish: Du skal i reglen injicere to doser á 0,5 ml om dagen, medmindre din læge har ordineret en lavere dosis til dig.
English: Hold the needle either vertically (90°) or at a 45° angle to the skin and insert it under the skin as far as it will go in one quick motion.
Danish: Hold kanylen enten lodret (90°) eller i en 45° vinkel i forhold til huden og før den så langt ind under huden, den kan komme, i én hurtig bevægelse.
English: For further instructions on how to inject this medicine yourself, please read the section “INSTRUCTIONS FOR SELF-INJECTION OF CEPLENE” at the end of this leaflet.
Danish: For yderligere oplysninger om, hvordan du skal injicere lægemidlet, kan du læse afsnittet “VEJLEDNING I SELVINJEKTION AF CEPLENE” sidst i indlægssedlen.
English: If the patient experiences a significant change in vital signs, the physician should evaluate the status of the patient and continue to monitor vital signs; these patients should be monitored during subsequent treatments.
Danish: Hvis der forekommer signifikant ændring i en patients vitale tegn, bør lægen vurdere patientens tilstand og fortsætte overvågningen, og under efterfølgende behandlinger bør disse patienter fortsat overvåges.
English: In the absence of compatibility studies this medicinal product should not be mixed with other medicinal products, diluents or infusion solutions.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette lægemiddel ikke blandes med andre lægemidler, diluenter eller infusionsopløsninger.
English: If you have had an infection within 14 days of starting this treatment which required you to take medicines to treat infections (antibiotics, antifungals or antivirals), your doctor will closely monitor you.
Danish: Hvis du har haft en infektion inden for de sidste 14 dage før denne behandling påbegyndtes, som indebar, at du var nødt til at tage medicin for at behandle infektionerne (antibiotika, svampemidler eller virusbekæmpende medicin), vil din læge ligeledes overvåge dig omhyggeligt.
English: Treatment cycles
Danish: Behandlingscyklusser
English: • If you are allergic (hypersensitive) to histamine or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis du er overfølsom (allergisk) over for histamin eller et af de øvrige indholdsstoffer i Ceplene (angivet i afsnit 6).
English: Your doctor will check your blood pressure, pulse rate and lung function.
Danish: Lægen kontrollerer dit blodtryk, din puls og lungefunktionen.
English: There have been 2 clinical studies to evaluate the use of Ceplene in the maintenance of remission in adult AML patients.
Danish: Der er gennemført 2 kliniske undersøgelser for at vurdere brugen af Ceplene til fastholdelse af remission hos voksne AML-patienter.
English: Your doctor may advise you that it is appropriate to use a syringe pump to regulate the injection of Ceplene.
Danish: Din læge kan tilråde, at du bruger en sprøjtepumpe for at regulere indsprøjtningen af Ceplene.
English: If you want to stop taking Ceplene you should try to consult your doctor in advance.
Danish: Hvis du ønsker at stoppe med at tage Ceplene skal du kontakte din læge på forhånd.
English: Localised toxic dermatitis - treatment should be discontinued until symptoms resolved.
Danish: Lokaliseret toksisk dermatitis - Behandlingen bør seponeres, indtil symptomerne er forsvundet.
English: Do not use if the date has passed the last day of the month shown.
Danish: Produktet må ikke anvendes, hvis den sidste dag i den måned, der er angivet, er overskredet.
English: -for grade 2 toxicity, the IL-2 dose should be reduced 50% and only increased to full dose if the symptoms do not reappear.
Danish: - Ved grad 2-toksicitet bør IL-2-dosis reduceres med 50 % og kun øges til fuld dosis, hvis symptomerne ikke opstår igen.
English: If you feel faint or dizzy during or after the injections, tell your doctor before injecting your next dose.
Danish: Hvis du føler dig svag eller svimmel under eller efter injektionerne, bør du fortælle din læge det, før du injicerer næste dosis.
English: Histamine dihydrochloride was not teratogenic in rats or rabbits at doses resulting in several hundredfold greater systemic exposures than the clinical exposure.
Danish: Histamindihydrochlorid var hverken teratogent hos rotter eller kaniner ved doser, der resulterede i flere hundrede gange højere systemisk eksponering end klinisk eksponering.
English: This table also provides the volume required if a 20% dose reduction is prescribed.
Danish: Tabellen indeholder ligeledes volumenangivelser, hvis 20 % dosisreduktion ordineres.
English: Each carton contains 14 vials.
Danish: Hver æske indeholder 14 hætteglas.
English: Please inform your doctor immediately if you have stopped taking Ceplene by your own decision.
Danish: Kontakt straks din læge hvis, du på egen beslutning, er stoppet med at tage Ceplene.
English: There are no significant effects of age or weight on the pharmacokinetic properties of histamine.
Danish: Der er ingen signifikante virkninger med hensyn til alder og vægt på histaminets farmakokinetiske egenskaber.
English: Beta-blockers and other anti-hypertensive agents should be used with caution during treatment with Ceplene.
Danish: Beta-blokkere og andre antihypertensiva bør anvendes med forsigtighed ved behandling med Ceplene.
English: It is used together with low doses of interleukin-2 (IL-2), another medicine which helps the immune system to fight diseases like cancer.
Danish: Det anvendes sammen med lave doser af interleukin-2 (IL-2), som er et andet lægemiddel, der hjælper immunsystemet til at bekæmpe sygdomme som kræft.
English: Remain seated or lying down for 20 minutes after injecting Ceplene.
Danish: Bliv siddende eller liggende i 20 minutter efter injektion af Ceplene.
English: It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Danish: Det er vigtigt, at du ikke forsøger at give dig selv injektioner, medmindre du har fået særlig instruktion heri af din læge eller sygeplejerske.
English: Histamine concentrations and PK were highly variable across studies, as well as within the normal volunteer and patient groups.
Danish: Histaminkoncentrationer og PK varierede meget på tværs af undersøgelserne samt inden for grupperne af raske frivillige og patientgrupper.
English: You will start your treatment with Ceplene in the clinic under supervision of a doctor.
Danish: Du påbegynder behandlingen med Ceplene på hospitalet under overvågning af en læge.
English: Patient monitoring during subsequent treatment days or cycles should be performed as long as the patient continues to experience significant changes in vital signs during administration of Ceplene.
Danish: På de efterfølgende behandlingsdage eller -cyklusser bør overvågningen fortsættes, så længe patienten oplever signifikante ændringer i vitale tegn under behandlingen med Ceplene.
English: Your doctor may decide that it would be more convenient for you to inject IL-2 and Ceplene yourself.
Danish: Din læge kan beslutte, at det vil være mere praktisk for dig at injicere IL-2 og Ceplene selv.
English: Obtain new supplies and start the procedure over again, even if 3 minutes have passed after injection of IL-2.
Danish: Tag nye forsyninger frem og start forfra igen, selvom der er gået 3 minutter efter injektion af IL-2.
English: Where appropriate, consideration should be made to providing concomitant treatment with a proton pump inhibitor.
Danish: Hvor det er relevant, bør samtidig behandling med en protonpumpehæmmer overvejes.
English: Also, if you are to have an operation or special X-ray investigation requiring an injection, first make sure that your doctor knows that you are receiving Ceplene.
Danish: Hvis du skal gennemgå en operation eller speciel røntgenundersøgelse, som kræver injektion, skal du først sikre dig, at din læge ved, at du får Ceplene.
English: Rapid subcutaneous injection or injection into a vascular space may result in severe hypotension, tachycardia, or syncope.
Danish: Hurtig subkutan injektion eller injektion i et vaskulært område kan forårsage alvorlig hypotension, takykardi eller synkope.
English: • Patients receiving systemic steroid therapy, clonidine and H2 blocking agents.
Danish: • Patienter i behandling med systemisk steroidbehandling, clonidin og H2-blokkere.
English: Additional side effects observed when Ceplene was used in other types of treatment:
Danish: Yderligere bivirkninger, der er observeret, når Ceplene blev brugt til andre typer behandling
English: Ceplene is for subcutaneous use only.
Danish: Ceplene er kun til subkutan anvendelse.
English: - IL-2 can be discontinued for 24 hours and then restarted at a 20% dose reduction level.
Danish: - IL-2-indgift kan seponeres i 24 timer og derefter genoptages ved et 20 % reduceret dosisniveau.
English: Patients should remain at rest for 20 minutes after injection of Ceplene.
Danish: Patienter bør forholde sig i ro i 20 minutter efter injektion af Ceplene.
English: • Pain and formation of extra tissue in the skin around the injection site
Danish: • Smerter og ekstra vævsdannelse omkring injektionsstedet.
English: Cycles w.19
Danish: Cyklusser u.19
English: • Drying-out of the body (dehydration)
Danish: • Udtørring af kroppen (dehydrering)
English: - Neuromuscular blocking agents, narcotic analgesics, and various contrast media.
Danish: - Neuromuskulære blokkere, narkotiske analgetika og forskellige kontrastmedier.
English: Subsequent injections of Ceplene may be self-administered at home by a patient who demonstrates a good understanding of necessary precautions and who has demonstrated adequate injection skills.
Danish: Efterfølgende Ceplene-injektioner kan foretages i hjemmet af patienten selv, hvis denne udviser god forståelse for de nødvendige forholdsregler og har vist tilstrækkelig færdighed til at foretage injektionen.
English: • Feeling of general discomfort or unease
Danish: • Følelse af alment ubehag eller gener
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald heraf bør bortskaffes i henhold til lokale retningslinjer.
English: Side effects observed when Ceplene is used as described in this package leaflet:
Danish: Bivirkninger, der er observeret, når Ceplene anvendes som beskrevet i denne indlægsseddel
English: Patients with clinically significant infection requiring the use of antibiotics, antifungals, or antivirals, or who have completed prior anti-infectious therapy within 14 days of starting treatment should be treated with caution unless the use of antibiotics and antivirals were for prophylaxis purposes.
Danish: Patienter med klinisk signifikant infektion, som kræver behandling med antibiotika, antimykotika eller antivirale midler, eller patienter, som inden for 14 dage før initiering af behandling har gennemgået behandling mod infektion, bør behandles med forsigtighed, medmindre brugen af antibiotika og antivirale midler havde profylaktiske formål.
English: Patients should be provided with capped polypropylene syringes and instructed to extract 0.5 mL of solution into the syringe.
Danish: Patienterne bør forsynes med polypropylensprøjter med hætte og få besked på at trække 0,5 ml opløsning op i sprøjten.
English: Very common dehydration
Danish: Meget almindelig dehydrering
English: Decide where you will inject Ceplene.
Danish: Beslut, hvor du vil injicere Ceplene.
English: Notice the numbered marks on it. Each mark (0.1, 0.2, 0.3, etc.) represents one-tenth of a millilitre (0.1 mL).
Danish: Bemærk de nummererede markeringer på den. Hver markering (0,1, 0,2, 0,3 osv.) udgør en tiendedel milliliter (0,1 ml).
English: When the syringe is empty, remove the needle from your skin.
Danish: Når sprøjten er tom, tager du kanylen ud af huden.
English: There are no data available on pharmacodynamic properties in children below 18 years of age.
Danish: Der foreligger ingen data for dens farmakodynamiske virkning hos børn og unge under 18 år.
English: Histamine is eliminated by metabolism in kidney, liver and other tissues.
Danish: Histamin udskilles ved metabolisme i nyrerne, leveren og andre væv.
English: For example, if you inject IL-2 in the left arm, you could inject Ceplene into the left or right thigh, the stomach, or the right arm.
Danish: Hvis du f.eks. injicerer IL-2 i venstre arm, kan du injicere Ceplene i venstre eller højre lår, maven eller højre arm. Sørg for altid at skifte injektionssted.
English: The randomised phase 3 trial (0201) compared Ceplene+IL-2 treatment to no treatment in 261 patients in first remission (CR1) and in another 59 patients in subsequent remission after relapse (CR>1).
Danish: Den randomiserede fase III-undersøgelse (0201) sammenlignede Ceplene plus IL-2-behandling med ingen behandling hos 261 patienter i første remission (CR1) og hos yderligere 59 patienter i efterfølgende remission efter recidiv (CR>1).
English: Notice the numbered marks on each syringe.
Danish: Bemærk de nummererede markeringer på sprøjten.
English: The needle must be inserted under the skin, but not into any blood vessels below the skin.
Danish: Kanylen skal indsættes i huden, men må ikke ramme blodkar under huden.
English: IL-2 has to be injected first.
Danish: IL-2 skal injiceres først.
English: A maximum delay of one treatment cycle can be considered for the resolution of grade 3 and 4 events.
Danish: Det kan overvejes at udsætte behandlingen med maksimalt én behandlingscyklus for at bringe grad 3- og 4hændelserne til ophør.
English: If you have had one of the following conditions you will be monitored in the hospital during the next treatment days or the next cycles of treatment:
Danish: Hvis du har haft nogen af følgende lidelser, vil du blive overvåget på hospitalet under de næste behandlingsdage eller de næste omgange af behandlingen: blødende sår,
English: Since you will be using both IL-2 and Ceplene in a combined treatment, information about both dosages is provided:
Danish: Da du skal bruge både IL-2 og Ceplene i en kombineret behandling, får du information om begge doser:
English: Patients with all degrees of hepatic impairment may have tachycardia or hypotension for 30-60 minutes after Ceplene+IL-2 administration.
Danish: Patienter med alle grader af leverinsufficiens kan opleve takykardi eller hypotension i 30-60 minutter efter indgivelsen af Ceplene+IL-2.
English: If you are taking any other medicines mentioned under “Other medicines and Ceplene” or if you are to have an operation or special X-ray investigation requiring an injection, talk to your doctor.
Danish: Hvis du tager anden medicin, som er nævnt under “Anvendelse af anden medicin sammen med Ceplene”, eller hvis du skal gennemgå en operation eller speciel røntgenundersøgelse, som kræver en injektion, så tal med lægen om det.
English: Animal studies showed reproductive toxicity but only at maternotoxic doses, and did not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyrestudie har vist reproduktionstoksicitet, men kun ved maternotoksiske doser, og der er ikke indikeret direkte skadelige virkninger hvad angår graviditet, embryonal/føtal udvikling, fødselsproces eller postnatal udvikling (se punkt 5.3).
English: Clearance of Ceplene is almost twice as high in females resulting in considerably lower systemic exposure than in males.
Danish: Clearance af Ceplene er næsten dobbelt så høj hos kvinder som hos mænd, hvilket betyder en væsentlig lavere eksponering end hos mænd.
English: Treatment should only be resumed after consideration of risk - benefit to the patient.
Danish: Behandling bør ikke genoptages, før der er foretaget en risk/benefit-vurdering for patienten.
English: Do not lay the syringe down or let the needle touch anything.
Danish: Læg ikke sprøjten fra dig, og lad ikke kanylen berøre noget.
English: The main enzymes involved in the metabolism of histamine are HNMT (histamine-N-methyltransferase) and DAO (diamine oxidase).
Danish: De vigtigste enzymer, som medvirker ved nedbrydning af histamin, er HNMT (histamin-N-metyltransferase) og DAO (diaminoxidase).
English: Dosing volumes based on patient weight are provided in Table 3 below.
Danish: Doseringsvoluminet skal baseres på patientens vægt og fremgår af nedenstående tabel 3.
English: • The active substance is histamine dihydrochloride.
Danish: • Aktivt stof: histamindihydrochlorid.
English: Detailed information on this medicine is available on the European Medicine Agency website: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Overall systemic exposure of Ceplene was greater in patients versus healthy subjects.
Danish: Samlet systemisk eksponering for Ceplene var større hos patienter end de raske personer.
English: Content of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger
English: Metabolism and nutrition disorders decreased appetite
Danish: Metabolisme og ernæring nedsat appetit
English: It is unknown whether histamine is excreted in human breast milk.
Danish: Det vides ikke, hvorvidt histamin udskilles i human modermælk.
English: For CR1 patients, the median duration of leukaemia-free survival increased from 291 days (9.7 months) to 450 days (15 months) after Ceplene/IL-2 versus no maintenance treatment (Intention to Treat [ITT], p=0.01.
Danish: For CR1-patienter øgedes den gennemsnitlige varighed af leukæmifri overlevelse fra 291 dage (9,7 måneder) til 450 dage (15 måneder) efter Ceplene/IL-2 i forhold til ingen vedligeholdelsesbehandling (Intention to Treat [ITT], p=0,01.
English: Plasma drug levels were not predictive of adverse effects, however, and effects did not correlate closely with drug exposure.
Danish: Lægemiddelniveauerne i plasma var dog ikke prædiktiv for bivirkninger, og virkningen af lægemidlet korrelerede ikke fuldt ud med eksponeringen for lægemidlet.
English: No carcinogenicity studies have been performed on Ceplene.
Danish: Der er ikke udført karcinogenicitetsundersøgelser for Ceplene.
English: Ceplene with IL-2 will help your immune system attack any remaining cancer cells after a previous cancer treatment.
Danish: Ceplene med IL-2 vil hjælpe dit immunsystem med at angribe resterende kræftceller efter en forudgående behandling mod kræft.
English: -for grade 4 toxicity, discontinuation of treatment should be considered.
Danish: - Ved grad 4-toksicitet bør seponering af behandlingen overvejes.
English: • Pain in limbs and back pain
Danish: • Smerter i lemmer og ryg
English: Each mark (0.1, 0.2, 0.3, etc.) represents one-tenth of a millilitre (0.1 mL).
Danish: Hver markering (0,1, 0,2, 0,3 osv.) udgør en tiendedel milliliter (0,1 ml).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: Ceplene must be injected slowly in the layer of tissue just under the skin (subcutaneously), over a period of approximately 5 to 15 minutes.
Danish: Ceplene skal injiceres langsomt i vævslaget lige under huden (subkutant) over en periode på cirka 5 til 15 minutter.
English: Injections should be preferably administered in a supervised setting in the presence of an adult family member, friend, or other care provider who is capable of responding appropriately should signs or symptoms of hypotension occur.
Danish: Injektioner skal helst foretages i overvågede omgivelser under tilstedeværelse af et voksent familiemedlem, en ven eller anden omsorgsperson, som er i stand til at reagere korrekt, hvis der skulle vise sig tegn eller symptomer på hypotension.
English: Doses of Ceplene and IL-2 should be modified as necessary based on individual patient tolerance to treatment.
Danish: Ceplene og IL-2-doserne bør justeres efter behov på grundlag af den enkelte patients tolerance over for behandlingen.
English: Patients with renal impairment may be more sensitive to the blood pressure lowering effects of Ceplene.
Danish: Patienter med nyreinsufficiens kan være mere følsomme over for den blodtrykssænkende virkning af Ceplene.
English: This section contains information on how to give yourself an injection of Ceplene.
Danish: Dette afsnit indeholder oplysninger om, hvordan du selv injicerer Ceplene.
English: In subjects with severe renal impairment, there were decreases in systolic and diastolic blood pressure at plasma histamine concentrations which caused no appreciable decrease in blood pressure in other subjects.
Danish: Hos personer med svær nyreinsufficiens blev der observeret fald i det systoliske og diastoliske blodtryk ved histamin-plasmakoncentrationer, som ikke forårsagede nævneværdigt blodtryksfald hos andre personer.
English: Always inject IL-2 first.
Danish: Injicér altid IL-2 først.
English: Monoamine oxidase inhibitors, anti-malarial, and anti-trypanosomal active substances may alter the metabolism of Ceplene and should be avoided (see section 4.4).
Danish: Monoaminoxidasehæmmere, malariamedicin og antitrypanosomalt aktive stoffer kan ændre metabolismen af Ceplene og bør undgås (se punkt 4.4).
English: Plasma histamine concentrations were highly variable and were considerably higher in the groups of patients with moderate or severe hepatic impairment (medians 10 and 5 times the normal volunteers respectively).
Danish: Histaminkoncentrationerne i plasma varierede meget og var betydeligt højere hos patientgrupper med moderat eller svær leverinsufficiens (henholdsvis 10 og 5 gange i gennemsnit sammenlignet med raske frivillige).
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppering er bivirkningerne ordnet efter faldende sværhedsgrad.
English: Ceplene should be used with caution in patients with moderate to severe hepatic impairment (see section 5.2).
Danish: Ceplene bør anvendes med forsigtighed til patienter med moderat til svær leverinsufficiens (se punkt 5.2).
English: Patients showed a higher degree of variability with respect to systemic exposure as compared to healthy subjects.
Danish: Patienterne udviste større forskellighed med hensyn til systemisk eksponering end de raske personer.
English: Cycle 1 Cycle 2 Cycle 3 w.1 to w.3 (Days 1-21)
Danish: Cyklus 1 Cyklus 2 Cyklus 3 u.1 til u.3 (Dag 1-21)
English: Certain medicines used for an operation (for example neuromuscular blocking medicines and narcotic pain-killers) or dyes used for certain Xrays may interfere with this medicine.
Danish: Visse lægemidler, der bruges ved en operation (for eksempel neuromuskulært blokerende lægemidler og narkotiske smertestillende midler) eller kontraststoffer, der bruges til visse røntgenundersøgelser, kan påvirke virkningen af dette lægemiddel.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg din læge eller dit apotek til råds, inden du tager nogen form for medicin.
English: Healthcare professionals are asked to report any suspected adverse reactions.
Danish: Læger og sundhedspersonale anmodes om at indberette alle mistænkte bivirkninger.
English: Ceplene inhibits NAPDH oxidase which initiates the formation and release of ROS from phagocytes.
Danish: Ceplene hæmmer NAPDH-oxidase, som initierer dannelse og frigørelse af ROS ud fra fagocytter.
English: For general information about the dosage and how to use Ceplene and IL-2, please see section 3, “How to use Ceplene”.
Danish: For generelle oplysninger om dosering og anvendelse af Ceplene og IL-2 henvises til afsnit 3, “Sådan skal du tage Ceplene”.
English: Each 0.5 mL Ceplene dose is injected slowly, over 5-15 minutes.
Danish: Hver dosis 0,5 ml Ceplene injiceres langsomt over 5-15 minutter.
English: Table 1: For treatment cycles 1-3 with Ceplene and IL-2
Danish: Tabel 1: Behandlingscyklus 1-3 med Ceplene og IL-2
English: If you accidentally inject more than you were told to, contact your doctor or pharmacist immediately.
Danish: Hvis du kommer til at injicere mere, end du har fået besked om, skal du kontakte din læge eller apoteket med det samme.