FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temozolomide Sandoz is being used alone or with other treatments, and how the patient responds to treatment.
Danish: Dosis og antallet af doser afhænger af, hvilken kræfttype der skal behandles, om patienten er blevet behandlet før, om Temozolomide Sandoz anvendes alene eller sammen med andre behandlinger, og hvordan patienten responderer på behandlingen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Temozolomide Sandoz on 15 March 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Temozolomide Sandoz den 15. marts 2010.
English: The dose of Temozolomide Sandoz depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Danish: Dosis af Temozolomide Sandoz afhænger af kropsoverfladen (beregnet ud fra patientens højde og vægt) og ligger på mellem 75 mg og 200 mg pr. kvadratmeter en gang dagligt.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Temozolomide Sandoz.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Temozolomide Sandoz.
English: This is a summary of the European Public Assessment Report (EPAR) for Temozolomide Sandoz.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Temozolomide Sandoz.
English: For more information about treatment with Temozolomide Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Temozolomide Sandoz, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Temozolomide Sandoz should be taken without food.
Danish: Temozolomide Sandoz skal tages uden mad.
English: This means that Temozolomide Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Danish: Det betyder, at Temozolomide Sandoz er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Temodal.
English: The CHMP concluded that, in accordance with EU requirements, Temozolomide Sandoz has been shown to have comparable quality and to be bioequivalent to Temodal.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Temozolomide Sandoz er af sammenlignelig kvalitet og er bioækvivalent med Temodal.
English: Temozolomide Sandoz is used on its own in these patients.
Danish: Temozolomide Sandoz anvendes alene hos disse patienter.
English: Patients may also need to take medicines to prevent vomiting before taking Temozolomide Sandoz.
Danish: Det kan ligeledes være nødvendigt at give patienten et middel mod opkastninger inden indtagelsen af Temozolomide Sandoz.
English: Treatment with Temozolomide Sandoz should be prescribed by a doctor with experience in the treatment of brain tumours.
Danish: Behandling med Temozolomide Sandoz skal ordineres af en læge, som har erfaring med behandling af hjernesvulster.
English: Temozolomide Sandoz is used first with radiotherapy and then on its own;
Danish: Temozolomide Sandoz bruges først sammen med strålebehandling og herefter alene.
English: Because Temozolomide Sandoz is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Temozolomide Sandoz er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses risk/benefit-forholdet for at være det samme som for referencelægemidlet.
English: The active substance in Temozolomide Sandoz, temozolomide, belongs to a group of anticancer medicines called alkylating agents.
Danish: Det aktive stof i Temozolomide Sandoz, temozolomid, tilhører en gruppe lægemidler mod kræft kaldet alkylerende midler.
English: The Committee recommended that Temozolomide Sandoz be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Temozolomide Sandoz.
English: Other information about Temozolomide Sandoz
Danish: Andre oplysninger om Temozolomide Sandoz
English: Temozolomide Sandoz is a ‘generic medicine'.
Danish: Temozolomide Sandoz er et "generisk lægemiddel".
English: Because Temozolomide Sandoz is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Danish: Da Temozolomide Sandoz er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Temodal.
English: Temozolomide Sandoz is a medicine that contains the active substance temozolomide.
Danish: Temozolomide Sandoz er et lægemiddel, der indeholder det aktive stof temozolomid.
English: What are the benefit and risk of Temozolomide Sandoz?
Danish: Hvilken fordel og risiko er der forbundet med Temozolomide Sandoz?
English: Temozolomide Sandoz is an anticancer medicine.
Danish: Temozolomide Sandoz er et lægemiddel mod kræft.
English: Temozolomide Sandoz temozolomide
Danish: Temozolomide Sandoz temozolomid
English: Why has Temozolomide Sandoz been approved?
Danish: Hvorfor blev Temozolomide Sandoz godkendt?
English: What is Temozolomide Sandoz?
Danish: Hvad er Temozolomide Sandoz?
English: How has Temozolomide Sandoz been studied?
Danish: Hvordan blev Temozolomide Sandoz undersøgt?
English: What is Temozolomide Sandoz used for?
Danish: Hvad anvendes Temozolomide Sandoz til?
English: How is Temozolomide Sandoz used?
Danish: Hvordan anvendes Temozolomide Sandoz?
English: How does Temozolomide Sandoz work?
Danish: Hvordan virker Temozolomide Sandoz?
English: From a microbiological point of view the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør produktet anvendes straks.
English: Ideal body weight can be determined using the following equations:
Danish: Den ideelle legemsvægt kan fastlægges med anvendelse af følgende ligninger:
English: • if you have or have had any heart problems.
Danish: • hvis du har eller har haft hjerteproblemer.
English: Elderly patients (> 65 years old)
Danish: Ældre personer (> 65 år)
English: Date of first authorisation: 31 July 2009 Date of latest renewal: 11 April 2014
Danish: Dato for første markedsføringstilladelse: 31. juli 2009 Dato for seneste fornyelse: 11. april 2014
English: Appropriate precautions should be taken because of the potential for these reactions.
Danish: Der skal udvises forsigtighed på grund af risikoen for disse reaktioner.
English: Please tell your doctor immediately if
Danish: Fortæl det straks til lægen, hvis
English: In a few cases, enough stem cells may not be collected, and the collection attempt will be stopped.
Danish: I nogle få tilfælde kan der muligvis ikke indsamles nok stamceller, og forsøget på at indsamle dem vil blive afbrudt.
English: Your medicine will be injected by a doctor or a nurse.
Danish: Din medicin vil blive injiceret af en læge eller sygeplejerske.
English: The elimination rate from tissues was slow.
Danish: Elimineringsraten fra væv var langsom.
English: Your doctor may adjust the dose.
Danish: Lægen vil muligvis justere din dosis.
English: The clinical relevance of these findings is not known.
Danish: Den kliniske relevans af disse fund kendes ikke.
English: About one in five patients suffered from these feelings.
Danish: Cirka én ud af fem patienter får disse bivirkninger.
English: This teratogenic potential is likely due to its pharmacodynamic mechanism of action.
Danish: Dette teratogene potentiale skyldes sandsynligvis dets farmakodynamiske virkningsmekanisme.
English: ** From post-marketing experience
Danish: ** Erfaring efter markedsføring
English: It is important to tell your doctor if you are, think you may be or are planning to become pregnant.
Danish: Det er vigtigt, at du fortæller det til lægen, hvis du er gravid, kan være gravid, eller planlægger at blive gravid.
English: * The frequency of allergic reactions presented is based on adverse reactions that occurred in the oncology studies (679 patients).
Danish: * Hyppigheden af de anførte allergiske reaktioner er baseret på bivirkninger, der opstod i onkologistudier (679 patienter).
English: • low red blood cell count by laboratory test (anaemia in children)
Danish: • lavt antal røde blodlegemer påvist i laboratorieprøve (anæmi hos børn)
English: G-CSF will help Mozobil to work properly in your body.
Danish: G-CSF hjælper Mozobil med at virke rigtigt i din krop.
English: The safety profile in this paediatric study was consistent with what has been observed in adults.
Danish: Sikkerhedsprofilen i dette pædiatriske studie var i overensstemmelse med den, der blev observeret hos voksne.
English: Do not use this medicine after the expiry date which is stated on the carton and vial.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på kartonen og hætteglasset.
English: It is recommended to use contraception if you are of child-bearing age.
Danish: Det anbefales at anvende prævention, hvis du er i den fødedygtige alder.
English: The elimination half-life (t1/2) in plasma is 3-5 hours.
Danish: Halveringstiden (t1/2) i plasma er 3-5 timer.
English: Treatment lasts 2 to 4 consecutive days (in some cases up to 7 days), until enough stem cells have been collected for your transplant.
Danish: Behandlingen varer 2 til 4 dage i træk (i nogle tilfælde i op til 7 dage), indtil der er indsamlet nok stamceller til din transplantation.
English: Plerixafor is moderately bound to human plasma proteins up to 58%.
Danish: Plerixafor binder moderat til humane plasmaproteiner med op til 58 %.
English: Recommended concomitant medicinal products
Danish: Anbefalede samtidige lægemidler
English: Your dose will depend on your body weight, which should be measured the week before you receive your first dose.
Danish: Din dosis afhænger af din legemsvægt, som skal måles, i ugen før du får din første dosis.
English: • if you have high white blood cell counts.
Danish: • hvis du har et højt antal hvide blodlegemer.
English: The potential risk associated with this effect is expected to be low for the intended short term duration of dosing plerixafor in humans.
Danish: Den potentielle risiko, der er forbundet med denne effekt, forventes at være lav i den tilsigtede, korte varighed af doseringen af plerixafor til mennesker.
English: Your doctor may perform regular blood tests to monitor your blood cell count.
Danish: Din læge vil muligvis tage regelmæssige blodprøver for at kontrollere dit blodcelletal.
English: Percents determined by Kaplan Meier method b n includes all patients who received at least one day of apheresis
Danish: a Procentdele fastlagt efter Kaplan Meier-metoden b n omfatter alle patienter, som har fået mindst én dags aferese
English: In some instances, these patients experienced an increase in the number of circulating leukaemia cells.
Danish: I nogle tilfælde oplevede disse patienter en stigning i antallet af cirkulerende leukæmiceller.
English: Tell your doctor:
Danish: Kontakt lægen:
English: In the two placebo-controlled clinical studies of plerixafor, 24% of patients were ≥ 65 years old.
Danish: I de to placebokontrollerede kliniske studier med plerixafor var 24 % af patienterne ≥ 65 år.
English: Mozobil contains the active substance plerixafor which blocks a protein on the surface of blood stem cells.
Danish: Mozobil indeholder det aktive stof plerixafor, der blokerer for et protein på overfladen af blodstamceller.
English: female (kg):
Danish: kvinde (kg):
English: Frequencies are defined according to the following convention: 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 (cannot be estimated from the available data).
Danish: Frekvenserne defineres i henhold til følgende regel: Meget almindelig (≥ 1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: It is unknown whether plerixafor is excreted in human milk.
Danish: Det vides ikke, om plerixafor udskilles i human mælk.
English: Therefore, you should avoid driving if you feel dizzy, tired or unwell.
Danish: Kør derfor ikke, hvis du føler dig svimmel, træt eller utilpas.
English: No notable differences in the incidence of adverse reactions were observed in these elderly patients when compared with younger ones.
Danish: Der blev ikke observeret nogen bemærkelsesværdige forskelle i forekomsten af bivirkninger hos disse ældre personer sammenlignet med yngre patienter.
English: These findings suggest that plerixafor has a low potential for involvement in P450-dependent drug-drug interactions.
Danish: Disse fund tyder på, at plerixafor har ringe potentiale for P450-afhængige lægemiddel-lægemiddel-interaktioner.
English: Systemic Exposure (AUC0-10h) comparisons of fixed and weight based regimens
Danish: Sammenligning af systemisk eksponering (AUC0-10t) ved fastdosis-regime og vægtbaseret regime
English: There are no adequate data on the use of plerixafor in pregnant women.
Danish: Der er ingen eller utilstrækkelige data for anvendelse af plerixafor til gravide kvinder.
English: No complications or clinical symptoms of leukostasis were observed.
Danish: Der blev ikke observeret nogen komplikationer eller kliniske symptomer på leukostase.
English: Renal impairment had no effect on Cmax..
Danish: Nyreinsufficiens havde ingen effekt på Cmax.
English: You may also have an increase in white blood cells count (leucocytosis), in your blood tests.
Danish: Du kan også have et øget antal hvide blodlegemer (leukocytose) i dine blodprøver.
English: When is Mozobil given for the first time?
Danish: Hvornår gives Mozobil første gang?
English: Hyperleukocytosis
Danish: Hyperleukocytose
English: Mozobil should not be used during pregnancy unless the clinical condition of the woman requires treatment with plerixafor.
Danish: Mozobil må ikke anvendes under graviditet, medmindre kvindens kliniske tilstand nødvendiggør behandling med plerixafor.
English: Plerixafor improves the release of stem cells into the blood stream (mobilisation).
Danish: Plerixafor forbedrer frigivelsen af stamceller ud i blodbanen (mobilisering).
English: Plerixafor is rapidly absorbed following subcutaneous injection, reaching peak concentrations in approximately 30-60 minutes (tmax).
Danish: Plerixafor absorberes hurtigt efter subkutan injektion og når maksimumkoncentration inden for cirka 30-60 minutter (tmax).
English: Only one patient aged less than 2 years old was randomized to the plerixafor treatment arm.
Danish: Kun en patient under 2 år blev randomiseret til behandlingsarmen med plerixafor.
English: Studies in animals have shown teratogenicity (see section 5.3).
Danish: Dyrestudier har påvist teratogenicitet (se pkt.
English: If mobilisation is poor, Mozobil is used to help collect blood stem cells from the patient, for collection, storage and reintroduction (transplantation),
Danish: Hvis det er vanskeligt at mobilisere, anvendes Mozobil til at hjælpe med at opsamle blodstamceller fra patienten med henblik på indsamling, opbevaring og genindførelse (transplantation),
English: The exposure to plerixafor in these studies ranged from 1 to 7 consecutive days (median = 2 days).
Danish: Eksponeringen for plerixafor i disse studier var fra 1 til 7 dage i træk (median = 2 dage).
English: Common Insomnia Uncommon Abnormal dreams, nightmares
Danish: Almindelig Insomni Ikke almindelig Unormale drømme, mareridt
English: Plerixafor dose and treatment of patients weighing more than 175% of ideal body weight have not been investigated.
Danish: Dosis af plerixafor til behandling af patienter, der vejer mere end 175 % af den ideelle legemsvægt, er ikke undersøgt.
English: Pharmacotherapeutic group: Other immunostimulants; ATC code: L03AX16
Danish: Farmakoterapeutisk klassifikation: Andre immunstimulerende midler, ATC-kode: L03AX16.
English: Clinical data with this dose adjustment are limited.
Danish: Der findes kun begrænsede kliniske data vedrørende denne dosisjustering.
English: Please inform your doctor immediately if you experience chest discomfort.
Danish: Kontakt straks lægen, hvis du mærker ubehag i brystet.
English: These events were generally mild or moderate and occurred within approximately 30 min after Mozobil administration.
Danish: Bivirkningerne var generelt lette eller moderate og opstod inden for cirka 30 min efter indgivelse af Mozobil.
English: Rescue patients
Danish: Rescue-patienter
English: CD34+ cells mobilised by plerixafor are functional and capable of engraftment with long-term repopulating capacity.
Danish: CD34+ celler, der er mobiliseret af plerixafor, er funktionelle og kan transplanteres med langsigtet repopulation.
English: The dose of haematopoietic stem cells used for each transplant was determined by the investigator and all haematopoietic stem cells that were collected were not necessarily transplanted.
Danish: Den dosis hæmatopoietiske stamceller, der blev brugt til hver transplantation, blev fastlagt af investigator, og det var ikke nødvendigvis alle de opsamlede hæmatopoietiske stamceller, der blev transplanteret.
English: The stem cells can then be collected by a machine that separates blood constituents (apheresis machine), and subsequently frozen and stored until your transplant.
Danish: Stamcellerne kan indsamles ved hjælp af en maskine, der adskiller blodets indholdsstoffer (aferese-maskine), og derefter nedfryses og opbevares indtil transplantationen.
English: Mozobil may influence the ability to drive and use machines.
Danish: Mozobil kan muligvis påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Carcinogenicity studies with plerixafor have not been conducted.
Danish: Der er ikke udført studier af karcinogeniciteten af plerixafor.
English: However, mobilization of PB CD34+ count was observed in stage 2 of the trial.
Danish: Der blev imidlertid observeret mobilisering af PB CD34+ tal i 2. stadie af studiet.
English: One or more of these findings were usually observed at systemic exposures in the same order of magnitude or slightly higher than the human clinical exposure.
Danish: Et eller flere af disse fund blev normalt observeret ved systemiske eksponeringer, der var af samme størrelsesorden som eller en anelse højere end den humane kliniske eksponering.
English: • In adults who have lymphoma (a cancer of the white blood cells) or multiple myeloma (a cancer that affects plasma cells in the bone marrow).
Danish: • Hos voksne, der har lymfom (kræft i de hvide blodlegemer) eller multipelt myelom (en kræftform, som påvirker plasmacellerne i knoglemarven).
English: An increase of nonHodgkin's lymphoma growth was noted after a continuous administration of plerixafor for 28 days.
Danish: En stigning i væksten af non-Hodgkins lymfom blev noteret efter kontinuerlig indgivelse af plerixafor i 28 dage.
English: The mobilisation and apheresis procedures should be performed in collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
Danish: Mobiliserings- og aferese-procedurerne skal udføres i samarbejde med et onkologisk-hæmatologisk center, som har tilstrækkelig erfaring inden for dette område, og hvor overvågningen af de hæmatopoietiske progenitorceller kan gennemføres på korrekt vis.
English: From chemotherapy/ablative treatment in preparation of transplantation through 12 months post-transplantation, no significant differences in the incidence of adverse reactions were observed across treatment groups.
Danish: Fra tidspunktet for den tranplantationsforberedende kemoterapi/ablativ behandling til og med 12 måneder efter transplantationen blev der ikke observeret nogen signifikante forskelle i forekomsten af bivirkninger på tværs af behandlingsgrupperne.
English: No dose modifications are necessary in elderly patients with normal renal function.
Danish: Det er ikke nødvendigt at ændre dosis til ældre personer med normal nyrefunktion.
English: Genzyme Ireland Ltd. IDA Industrial Park Old Kilmeaden Road Waterford, Ireland
Danish: Genzyme Ireland Ltd. IDA Industrial Park Old Kilmeaden Road Waterford, Irland
English: The weight used to calculate the dose of plerixafor should be obtained within 1 week before the first dose of plerixafor.
Danish: Den vægt, der anvendes til beregning af dosis af plerixafor, skal måles inden for 1 uge inden den første dosis plerixafor.
English: Cases of splenic enlargement and/or rupture have been reported following the administration of Mozobil in conjunction with growth factor G-CSF.
Danish: Tilfælde af forstørrelse af milten og/eller ruptur er rapporteret efter administration af Mozobil sammen med vækstfaktor G-CSF.
English: • if you are allergic to plerixafor or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for plerixafor eller et af de øvrige indholdsstoffer i Mozobil (angivet i punkt 6).
English: You will receive your first dose 6 to 11 hours before apheresis (collection of your blood stem cells).
Danish: Du får din første dosis 6 til 11 timer inden opsamling af dine blodstamceller (aferesen).
English: Patients with leukemia, persistent high percentage marrow involvement prior to mobilization, or previous stem cell transplantation were excluded.
Danish: Patienter med leukæmi, vedvarende høj procentdel af knoglemarvpåvirkning forud for mobilisering eller med tidligere stamcelletransplantation blev ekskluderet.
English: SDF-1α and CXCR4 play major roles in embryo-foetal development.
Danish: SDF-1α og CXCR4 spiller en vigtig rolle i embryoets/fosterets udvikling.
English: Systemic exposure at No Observed Adverse Effect Level for teratogenic effects in rats and rabbits was of the same magnitude or lower as found at therapeutic doses in patients.
Danish: Den systemiske eksponering ved No Observed Adverse Effect Level for teratogene effekter hos rotter og kaniner var af samme omfang eller lavere end det, der er konstateret ved terapeutiske doser til patienter.
English: The effect of plerixafor on spleen size in patients has not been specifically evaluated in clinical studies.
Danish: Effekten af plerixafor på patienternes miltstørrelse er ikke blevet undersøgt specifikt i kliniske studier.
English: Median age was 5.3 years (min: max 1:18) in the Mozobil arm versus 4.7 years (min:max 1:17) in the control arm.
Danish: Medianalder var 5,3 år (min:max 1:18) i Mozobil-armen versus 4,7 år (min:max 1:17) i kontrolarmen.
English: Based on increasing exposure with increasing body weight, the plerixafor dose should not exceed 40 mg/day.
Danish: Baseret på øget eksponering med stigende legemsvægt bør dosis af plerixafor ikke overstige 40 mg/dag.
English: Method of administration Mozobil is for subcutaneous injection.
Danish: Administration Mozobil er til subkutan injektion.
English: All events occurred at least 14 days after last Mozobil administration.
Danish: Alle hændelser opstod mindst 14 dage efter sidste indgivelse af Mozobil.
English: The apparent volume of distribution of plerixafor in humans is 0.3 l/kg demonstrating that plerixafor is largely confined to, but not limited to, the extravascular fluid space.
Danish: Det synlige distributionsvolumen af plerixafor hos mennesker er 0,3 l/kg, hvilket viser, at plerixaflor overvejende er afgrænset men ikke begrænset til det ekstravaskulære væskerum.
English: In clinical trials, Mozobil has been commonly used for 2 to 4 (and up to 7) consecutive days.
Danish: I kliniske studier har Mozobil sædvanligvis været anvendt i 2-4 (og op til 7) dage i træk.