FrancophonIA/ELRC3.0 huggingface dataset:
English: ≥ 12 to < 18 years, n (%) ≥ 18 years, n (%) FEV1 Percent predicted Baseline mean (SD) Primary endpoint:
Danish: Forventet FEV1-procent Baseline-gennemsnit (SD) Primære endepunkt:
English: Renal failure*
Danish: Nyreinsufficiens*
English: - Seizures and convulsions
Danish: Nyrer og urinveje
English: Sachet
Danish: Taprille
English: Cardiac disorders
Danish: - Unormal hjerterytme
English: What Quinsair looks like and contents of the pack Quinsair is a clear, pale yellow nebuliser solution.
Danish: Quinsair er en klar, lysegul inhalationsvæske til nebulisator, opløsning.
English: Sixty-five percent of the patients studied in the SCN trial programme were under 18 years of age.
Danish: 65 % af de patienter, der indgik i SCN-forsøgsprogrammet, var under 18 år.
English: Filgrastim should not be used during pregnancy unless clearly necessary.
Danish: Filgrastim bør ikke anvendes under graviditet, med mindre det er klart nødvendigt.
English: It is also very important that you call your doctor if you think you may have an infection.
Danish: Det er også yderst vigtigt, at De kontakter lægen, hvis De tror, at De har fået en infektion.
English: • At the request of the EMEA
Danish: • på anmodning fra det Europæiske Lægemiddelagentur
English: Not all pack sizes may be marketed.
Danish: Det er ikke alle pakningsstørrelser, som er markedsført.
English: THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE
Danish: FØLGENDE OPLYSNINGER ER TILTÆNKT LÆGER OG SUNDHEDSPERSONALE:
English: The volume of distribution in blood is approximately 150 ml/kg.
Danish: Fordelingsvolumenet i blod er ca. 150 ml/kg.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and local tolerance.
Danish: De ikke-kliniske data viser ingen særlige farer for mennesker på basis af traditionelle studier af sikkerhedsfarmakologi, genotoksicitet og lokal tolerans.
English: Other special precautions Causes of transient neutropenia such as viral infections should be excluded.
Danish: Andre særlige forsigtighedsregler Årsager til forbigående neutropeni såsom virusinfektioner skal udelukkes.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald herfra bør bortskaffes i overensstemmelse med lokale krav.
English: The following frequency conventions are used in the evaluation of side effects:
Danish: Følgende frekvenssystem er brugt ved vurderingen af bivirkningerne:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 September 2008.
Danish: Dato for første markedsføringstilladelse: 15. september 2008 10.
English: Name and address of the manufacturer of the biological active substance SICOR Biotech UAB
Danish: ANSVARLIG FOR BATCHFRIGIVELSE Navn og adresse på fremstilleren af det biologisk aktive stof SICOR Biotech UAB
English: In clinical studies, > 90% of patients responded at these doses, achieving reversal of neutropenia in a median of 2 days.
Danish: I kliniske forsøg responderede > 90 % af patienterne på disse doser og opnåede reversering af neutropeni på 2 dage i gennemsnit.
English: You will find detailed information about the ingredient sorbitol (a sugar) in section 2. under the heading “Important information about some of the ingredients of Filgrastim ratiopharm”.
Danish: Nærmere oplysninger om indholdsstoffet sorbitol (en sukkerart) er angivet i afsnit 2 under "Vigtige oplysninger om visse af indholdsstofferne i Filgrastim ratiopharm".
English: POSSIBLE SIDE EFFECTS”).
Danish: 4 bivirkninger).
English: There are many ways an infection may show itself.
Danish: Infektioner kan vise sig på mange forskellige måder.
English: frequency cannot be estimated from the available data.
Danish: frekvensen kan ikke bestemmes ud fra af eksisterende data
English: The safety and efficacy of filgrastim have not been assessed in normal donors < 16 years or > 60
Danish: Filgrastims sikkerhed og effekt er ikke undersøgt hos raske donorer < 16 år eller > 60 år.
English: It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.
Danish: Det er vigtigt, at De straks kontakter lægen, hvis De får smerter øverst i venstre side af maven eller i venstre skulderparti, da det kan skyldes, at der er noget galt med milten.
English: The most suitable places to inject yourself are: - the abdomen, except for the area around the navel (see picture 3).
Danish: De mest velegnede steder til indsprøjtningen er: - i maven, undtagen i området omkring navlen (se figur 3).
English: During clinical studies 541 cancer patients and 188 healthy volunteers were exposed to Filgrastim ratiopharm.
Danish: I en række kliniske forsøg blev 541 cancerpatienter og 188 raske forsøgspersoner eksponeret for Filgrastim ratiopharm.
English: It is recommended to perform morphologic and cytogenetic bone marrow examinations in patients at regular intervals (approximately every 12 months).
Danish: Det anbefales at udføre regelmæssige morfologiske og cytogenetiske knoglemarvsundersøgelser hos patienterne (ca. hver 12. måned).
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Danish: Derfor bør miltstørrelsen monitoreres nøje (fx klinisk undersøgelse, ultralyd).
English: Pharmacotherapeutic group: Colony stimulating factors, ATC code: L03AA02
Danish: Terapeutisk klassifikation Kolonistimulerende faktorer, ATC-kode: L03AA02
English: Clinical trials with filgrastim have included a small number of elderly patients but special studies have not been performed in this group and therefore specific dosage recommendations cannot be made.
Danish: I kliniske forsøg med filgrastim indgik et mindre antal ældre patienter, men der foreligger ingen studier specielt med denne gruppe, hvorfor der ikke kan gives specifikke dosisanbefalinger.
English: The results of flow cytometric analysis of CD34+ cell numbers vary depending on the precise methodology used and therefore, recommendations of numbers based on studies in other laboratories need to be interpreted with caution.
Danish: Resultaterne af flowcytometrisk analyse af antallet af CD34+-celler afhænger af den anvendte metodik, og derfor bør rekommandationer af celleantal, der baseres på undersøgelser udført i andre laboratorier, fortolkes med forsigtighed.
English: - a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can
Danish: - en beholder til skarpe genstande (plastbeholder, der udleveres af hospitalet eller apoteket), så De
English: Like all medicines, Filgrastim ratiopharm can cause side effects, although not everybody gets them.
Danish: Filgrastim ratiopharm kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: There are no adequate data from the use of filgrastim in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data fra anvendelse af filgrastim til gravide kvinder.
English: Store in a refrigerator (2 °C - 8 °C).
Danish: Opbevares i køleskab (2 C - 8 C).
English: The safety and efficacy of filgrastim administration in de novo AML patients aged < 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.
Danish: Sikkerhed og effekt af filgrastim ved administration til patienter under 55 år med de novo-AML og god cytogenetik [t(8;21), t(15;17) og inv(16)] er ikke fastlagt.
English: Regular monitoring of blood counts is recommended (see
Danish: Regelmæssig monitorering af blodværdier anbefales (se ovenfor).
English: The incidence of these events was similar to that reported in cancer patients.
Danish: Incidensen af disse hændelser var den samme som rapporteret for cancerpatienter.
English: Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/ml for 8 to 16 hours.
Danish: Efter subkutan administration af de anbefalede doser opretholdtes en serumkoncentration på over 10 ng/ml i 8-16 timer.
English: If you forget to use Filgrastim ratiopharm Do not use a double dose to make up for a forgotten injection.
Danish: Hvis De har glemt at tage Filgrastim ratiopharm De må ikke tage en dobbeltdosis som erstatning for den glemte indsprøjtning.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis Deres læge har oplyst Dem om, at De ikke kan tåle visse sukkerarter, bør De kontakte lægen, før De tager dette lægemiddel.
English: Your doctor has prescribed Filgrastim ratiopharm for you to help your body make more white blood cells.
Danish: Deres læge har ordineret Filgrastim ratiopharm til Dem for at hjælpe Deres krop med at producere flere hvide blodceller.
English: It is important to tell your doctor if you are pregnant, think you may be pregnant or plan to get pregnant, as the doctor may decide that you
Danish: Det er vigtigt, at De fortæller det til lægen, hvis De er gravid, tror at De kunne være gravid eller forsøger at blive det. I så fald vil lægen måske beslutte, at De ikke skal have medicinen.
English: less than 1 user in 10,000
Danish: færre end 1 ud af 10.000 patienter)
English: Important information about some of the ingredients of Filgrastim ratiopharm This medicine contains sorbitol (a type of sugar).
Danish: Vigtiginformation om nogle af de øvrige indholdsstoffer i Filgrastim ratiopharm Denne medicin indeholder sorbitol (en sukkerart).
English: Filgrastim ratiopharm treatment will last for up to 2 weeks and in exceptional cases longer.
Danish: Behandlingen med Filgrastim ratiopharm varer i op til 2 uger og kan undtagelsesvis vare længere.
English: Find a comfortable, well-lit place and put everything you need where you can reach them (the Filgrastim ratiopharm pre-filled syringe, alcohol wipes and the puncture-proof container).
Danish: Find et bekvemt og veloplyst sted og anbring udstyret, hvor De let kan nå det (den fyldte sprøjte med Filgrastim ratiopharm, spritservietter og beholderen til affald).
English: The degree of variation between individual patients and between laboratory assays of CD34+ cells mean that direct comparison between different studies is difficult.
Danish: Omfanget af forskelle mellem patienterne og mellem forskellige laboratorieundersøgelser af CD34+-celler gør det vanskeligt at udføre direkte sammenligninger af forskellige afprøvninger.
English: Disinfect your skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 5).
Danish: Desinficer huden med en spritserviet, og tag godt fat i huden mellem tommel- og pegefinger uden at klemme til (se figur 5).
English: After dilution: Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2 °C to 8 °C.
Danish: Efter fortynding: Kemisk og fysisk stabilitet af den fortyndede infusionsopløsning er påvist i 24 timer ved 2 °C - 8 °C.
English: A subset of approximately 12% of patients who had normal cytogenetic evaluations at baseline were subsequently found to have abnormalities, including monosomy 7, on routine repeat evaluation.
Danish: En delgruppe på ca. 12 % af patienterne, som havde normal cytogenetik ved baseline, fik siden konstateret anomalier inklusive monosomi 7 ved en ny rutineundersøgelse.
English: Headache and diarrhoea have been reported shortly after starting filgrastim therapy, typically in less than 10% of patients.
Danish: Der er rapporteret hovedpine og diarré kort tid efter indledning af filgrastimterapi - typisk hos færre end 10 % af patienterne.
English: The safety profile of Filgrastim ratiopharm observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Danish: Sikkerhedsprofilen for Filgrastim ratiopharm i disse kliniske forsøg svarede til profilen for det referenceprodukt, der blev anvendt i forsøgene.
English: Subsequently the dose may be individually adjusted every 1 to 2 weeks to maintain the average neutrophil count between 1.5 x 109/l and 10 x 109/l.
Danish: Efterfølgende kan dosis justeres individuelt hver eller hver anden uge for at opretholde et gennemsnitligt neutrofiltal mellem 1,5 x 109/l og 10 x 109/l.
English: Filgrastim ratiopharm is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
Danish: Filgrastim ratiopharm er indiceret til mobilisering af perifere blodstamceller (PBPC).
English: In order to determine a patient's trough or nadir ANC, it is recommended that blood samples are taken for ANC measurement immediately prior to any
Danish: For at bestemme patientens ANC-minimum eller -nadir anbefales det at tage blodprøver til ANC-måling umiddelbart
English: If yields are inadequate, as measured by the criteria above, alternative forms of treatment not requiring progenitor support should be considered.
Danish: Hvis høsten er utilstrækkelig målt ud fra de ovennævnte kriterier, bør det overvejes at vælge andre behandlingsformer, der ikke kræver supplerende
English: Splenic enlargement was reported to be related to filgrastim therapy in < 3% of patients.
Danish: Forstørrelse af milten rapporteredes at være forbundet med filgrastimterapi hos < 3 % af patienterne.
English: If the patient is experiencing fatigue, caution is advised when driving a car or operating machinery.
Danish: Hvis patienten føler træthed bør forsigtighed udvises ved bilkørsel eller brug af maskiner.
English: As a very common side effect, filgrastim may cause bone and muscle pain.
Danish: Som en meget almindelige bivirkning kan filgrastim give knogle- og muskelsmerter.
English: - if you are allergic (hypersensitive) to filgrastim or to any of the other ingredients of Filgrastim ratiopharm.
Danish: - Hvis De er overfølsom (allergisk) over for filgrastim eller et af de øvrige indholdsstoffer.
English: If you have Sickle Cell Disease, make sure that you tell your doctor before you start taking Filgrastim ratiopharm.
Danish: Hvis De har seglcellesygdom, skal De fortælle det til lægen, før De begynder at få Filgrastim ratiopharm.
English: You will normally receive your first dose of Filgrastim ratiopharm at least 24 hours after your chemotherapy but within 24 hours of receiving your bone marrow transfusion.
Danish: Normalt vil De få den første dosis Filgrastim ratiopharm mindst 24 timer efter Deres kemoterapi, men inden for 24 timer efter at De får knoglemarvstransfusion.
English: Filgrastim ratiopharm has not been tested in pregnant women.
Danish: Filgrastim ratiopharm er ikke undersøgt hos gravide kvinder.
English: Take special care with Filgrastim ratiopharm - if you experience a cough, fever and difficulty breathing.
Danish: Vær ekstra forsigtig med at bruge Filgrastim ratiopharm - Hvis De får hoste, feber og vejrtrækningsbesvær.
English: It is quite normal to have a number of courses of Filgrastim ratiopharm treatment.
Danish: Det er helt normalt at få flere behandlingsforløb med Filgrastim ratiopharm.
English: The safety and efficacy of filgrastim given on the same day as myelosuppressive cytotoxic chemotherapy have not been definitively established.
Danish: Filgrastims sikkerhed og effekt, når det gives på samme dag som myelosuppressiv cytotoksisk kemoterapi, er ikke endeligt fastlagt.
English: 2 leukaphereses on days 5 and 6 are often sufficient.
Danish: Tidsplan for leukaferese: Ofte vil 1-2 leukafereser på dag 5 og 6 være tilstrækkeligt.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis den ikke bruges umiddelbart, har brugeren ansvaret for opbevaringstider og forhold før brug, som normalt ikke bør være mere end 24 timer ved 2 °C - 8 °C, med mindre fortyndingen er foretaget under kontrollerede
English: This section contains information on how to give yourself an injection of Filgrastim ratiopharm.
Danish: Dette afsnit indeholder oplysninger om, hvordan De kan give Dem selv indsprøjtninger med Filgrastim ratiopharm.
English: In cancer patients, the pharmacokinetic profile of Filgrastim ratiopharm and the reference product was comparable after single and repeated subcutaneous administration.
Danish: Hos cancerpatienter var den farmakokinetiske profil af Filgrastim ratiopharm og referenceproduktet sammenlignelige efter en enkelt og gentagne subkutane doser.
English: Relative risk (95% CI) of GvHD and TRM following treatment with G-CSF after bone marrow
Danish: Relativ risiko (95 % CI) for GvHD og BRM efter behandling med G-CSF efter
English: It is also important that you dispose of the syringe in a puncture-proof container.
Danish: Det er ligeledes vigtigt, at De anbringer den brugte sprøjte i en særlig beholder til skarpe genstande.
English: There were no relevant differences between Filgrastim ratiopharm and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Danish: Der sås ingen relevante forskelle mellem Filgrastim ratiopharm og referenceproduktet, hvad angår varighed af svær neutropeni og
English: The recommendation of a minimum yield of 2.0 x 106 CD34+ cells/kg is based on published experience resulting in adequate haematologic reconstitution.
Danish: Anbefalingen af en minimumshøst på 2,0 x 106 CD34+-celler/kg er baseret på publicerede erfaringer,
English: Leukocytosis, thrombocytopenia
Danish: Leukocytose, trombocytopeni
English: For storage conditions of the diluted medicinal product, see section 6.3.
Danish: Vedrørende opbevaringsbetingelser for det fortyndede lægemiddel, se pkt.
English: For patients treated with filgrastim diluted to concentrations below 1.5 MIU (15 μg) per ml, human serum albumin (HSA) should be added to a final concentration of 2 mg/ml.
Danish: Til patienter, der er behandlet med filgrastim, som er fortyndet til en koncentration under 1,5 mio. IE (15 μg) pr. ml, bør der tilføjes humant serumalbumin (HSA) til en slutkoncentration på 2 mg/ml.
English: Dose reductions were noted to slow or stop the progression of splenic enlargement and in 3% of patients a splenectomy was required.
Danish: Det bemærkedes, at dosisreduktioner nedsatte eller standsede progressionen af miltforstørrelse, og hos 3 % af patienterne opstod behov for splenektomi.
English: A meta-analysis of allogeneic transplant studies, including the results of nine prospective randomized trials, 8 retrospective studies and 1 case-controlled study, did not detect an effect on the risks of acute GvHD, chronic GvHD or early treatment-related mortality.
Danish: I en metaanalyse af studier med allogene transplantationer, som omfattede resultaterne fra ni prospektive, randomiserede forsøg, otte retrospektive studier og et case-kontrolleret studie, blev der ikke påvist nogen indflydelse på risikoen for akut GvHD, kronisk GvHD eller tidlig behandlingsrelateret mortalitet.
English: Among these, two cases of platelets < 50 x 109/l were reported and attributed to the leukapheresis procedure.
Danish: Herunder rapporteredes to tilfælde af trombocyttal < 50 x 109/l, som tilskrives leukafereseproceduren.
English: Take your Filgrastim ratiopharm pre-filled syringe out of the refrigerator.
Danish: Tag medicinsprøjten med Filgrastim ratiopharm ud af køleskabet.
English: Although this interaction has not been formally investigated, there is no evidence that such an
Danish: Et specifikt studie af denne interaktion er ikke udført, men der foreligger ingen dokumentation, der viser, at en sådan interaktion skulle være skadelig.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 5 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP
Danish: Indehaveren af markedsføringstilladelsen er forpligtet til at foretage de undersøgelser og supplerende pharmacovigilance-aktiviteter, som er beskrevet i pharmacovigilance-planen (ifølge aftalen i risikostyringsprogrammets (RMP) version 1.3, Modul 1.8.2 i markedsføringsansøgningen), og enhver efterfølgende opdatering af RMP, som er godkendt af CHMP.
English: The safety and efficacy in neonates and patients with autoimmune neutropenia have not been
Danish: Sikkerhed og effekt hos nyfødte og patienter med autoimmun neutropeni er ikke fastlagt.
English: Push the plunger up to the number (ml) on the syringe that matches the dose of Filgrastim ratiopharm that your doctor prescribed.
Danish: Tryk stemplet i til det antal millimeter (ml), der svarer til den ordinerede dosis Filgrastim ratiopharm.
English: The efficacy and safety of Filgrastim ratiopharm has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
Danish: Filgrastim ratiopharms sikkerhed og effekt er undersøgt i randomiserede, kontrollerede fase III-forsøg hos patienter med brystcancer, lungecancer og non-Hodgkin-lymfom.
English: Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established
Danish: Filgrastim bør ikke anvendes til at øge dosis af cytotoksisk kemoterapi ud over de fastlagte
English: Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned below.
Danish: Fortyndet filgrastim kan adsorberes til glas- og plastmaterialer, med mindre det fortyndes som angivet
English: Consideration should be given to intermittent cessation or decreasing the dose of filgrastim in patients who develop thrombocytopenia, i.e. platelets consistently < 100,000/mm3.
Danish: Det bør overvejes at indstille behandlingen midlertidigt eller nedsætte dosis af filgrastim hos patienter, der får trombocytopeni, d.v.s. trombocyttal vedvarende < 100.000/mm3.
English: In view of limited safety and efficacy data in patients with secondary AML, filgrastim should be administered with caution.
Danish: Da der foreligger begrænsede data om sikkerhed og effekt hos patienter med sekundær AML, bør der udvises forsigtighed ved administration af filgrastim.
English: In clinical trials, 97% of patients who responded had a complete response at doses of 2.4 MIU (24 μg)/kg/day.
Danish: I kliniske forsøg opnåede 97 % af respondenterne fuldstændigt respons ved doser på 2,4 mio. IE (24 μg)/kg/døgn.
English: Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Filgrastim ratiopharm was comparable to that of the reference product after subcutaneous and intravenous administration.
Danish: Randomiserede, enkeltblinde, crossover-forsøg med enkeltdosis, der omfattede 196 raske forsøgspersoner, viste, at Filgrastim ratiopharms farmakokinetiske profil var sammenlignelig med profilen af referenceproduktet efter subkutan og intravenøs administration.
English: The amount of Filgrastim ratiopharm you need will depend on the condition you are taking Filgrastim ratiopharm for and on your bodyweight.
Danish: Hvor meget Filgrastim ratiopharm, De skal have, afhænger af, hvorfor De skal have Filgrastim ratiopharm, og hvor meget De vejer.
English: Always use Filgrastim ratiopharm exactly as your doctor has told you.
Danish: Tag altid Filgrastim ratiopharm nøjagtigt efter lægens anvisning.
English: Rare pulmonary undesirable effects, in particular interstitial pneumonia, have been reported after GCSF administration.
Danish: Der er rapporteret sjældne pulmonale bivirkninger, især interstitiel pneumoni, efter administration af G-CSF.
English: Filgrastim ratiopharm containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Danish: Filgrastim ratiopharm indeholder r-metHuG-CSF (filgrastim), og det udvirker markante stigninger i neutrofiltallet i perifert blod i løbet af 24 timer samt mindre stigninger i antallet af monocytter.
English: In some disease types however, longer treatment lasting up to about one month may be required.
Danish: Ved nogle sygdomsformer kan der dog være behov for længere behandling