FrancophonIA/ELRC3.0 huggingface dataset:
English: Use of filgrastim in patients, children or adults, with SCN (severe congenital, cyclic, and idiopathic neutropenia) induces a sustained increase in absolute neutrophil counts in peripheral blood and a reduction of infection and related events.
Danish: Når filgrastim gives til børn eller voksne med SCN (svær medfødt, cyklisk og idiopatisk neutropeni), opnås en vedvarende stigning i det absolutte neutrofiltal i perifert blod og en reduktion af forekomsten
English: Check the appearance of Filgrastim ratiopharm.
Danish: Kontroller Filgrastim ratiopharms udseende.
English: Risks associated with increased doses of chemotherapy Special caution should be used when treating patients with high dose chemotherapy because improved tumour outcome has not been demonstrated and intensified doses of chemotherapeutic agents may lead to increased toxicities including cardiac, pulmonary, neurologic and dermatologic effects (please refer to the Summary of Product Characteristics of the specific chemotherapy agents used).
Danish: Der bør udvises særlig forsigtighed ved behandling af patienter med højdosis kemoterapi, da det ikke er påvist, at dette giver øget tumorrespons, og intensiv kemoterapi kan medføre øget toksicitet i form af påvirkning af hjerte, lunger, nervesystem og hud (se produktresumeet for de respektive
English: If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 x 109/l prior to leukapheresis; in general apheresis should not be performed if platelets < 75 x 109/l.
Danish: Hvis der kræves mere end én leukaferese, er det særlig vigtigt før leukaferesen at være opmærksom på donorer med trombocyttal < 100 x 109/l.
English: Allergic-type reactions to filgrastim, including skin rash, raised areas of the skin that itch and anaphylaxis (weakness, drop in blood pressure, difficulty breathing and swelling of the face) have been reported.
Danish: Der er indberettet allergiske reaktioner på filgrastim, der omfatter hududslæt, hævede hudområder med kløe og anafylaksi (svækkelse, blodtryksfald, vejrtrækningsbesvær og hævelser i ansigtet).
English: Common but generally asymptomatic cases of splenomegaly and very rare cases of splenic rupture have been reported in healthy donors and patients following administration of G-CSFs (see section
Danish: Der er rapporteret om almindelige, men generelt symptomfri tilfælde af splenomegali og meget sjældne tilfælde af miltruptur hos raske donorer og patienter efter administration af G-CSF (se pkt.
English: EU/1/08/449/003 2 x 5 pre-filled syringes
Danish: EU/1/08/449/001 EU/1/08/449/002 EU/1/08/449/003 EU/1/08/449/004
English: Your doctor will tell you why you are being treated with Filgrastim ratiopharm.
Danish: Lægen kan forklare Dem nærmere om, hvorfor De får Filgrastim ratiopharm.
English: Transient thrombocytopenia (platelets < 100 x 109/l) following filgrastim administration and leukapheresis was observed in 35% of subjects studied.
Danish: Der observeredes forbigående trombocytopeni (trombocyttal < 100 x 109/l) efter administration af filgrastim og leukaferese hos 35 % af de undersøgte donorer.
English: Filgrastim ratiopharm does not contain any preservative.
Danish: Filgrastim ratiopharm indeholder ingen konserveringsmidler.
English: Discontinuation of filgrastim therapy usually results in a 50% decrease in circulating neutrophils within 1 to 2 days, with a return to normal levels in 1 to 7 days.
Danish: Afbrydelse af behandlingen medfører sædvanligvis et fald på 50 % i cirkulerende neutrofile granulocytter i løbet af 1-2 døgn, hvorefter værdierne normaliseres i løbet af 1-7 døgn.
English: Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in glucose 50 mg/ml (5%) solution for infusion given over 30 minutes (see section 6.6 for instructions on dilution).
Danish: Filgrastim kan gives som en daglig subkutan injektion eller som en daglig intravenøs infusion efter fortynding med 50 mg/ml (5 %) glucose infusionsvæske over 30 minutter (se fortyndingsvejledningen i pkt.
English: Multipack comprising 2 packs, each containing 5 pre-filled syringes.
Danish: Multipakke bestående af 2 pakker med 5 fyldte injektionssprøjter hver.
English: The duration of fever was not reduced in patients undergoing myeloablative therapy followed
Danish: Feberens varighed blev ikke reduceret hos patienter, der fik myeloablativ terapi efterfulgt af knoglemarvstransplantation.
English: Filgrastim ratiopharm treatment will last for 4 to 5 days.
Danish: Behandlingen med Filgrastim ratiopharm varer i 4-5
English: The dosage recommendations in paediatric patients are the same as those in adults receiving myelosuppressive cytotoxic chemotherapy.
Danish: Dosisrekommandationerne til børn er de samme som til voksne, der får myelosuppressiv cytotoksisk
English: Once the neutrophil nadir has been passed the daily dose of filgrastim should be titrated against the
Danish: Når neutrofiltallets nadir er passeret, bør filgrastims døgndosis atter titreres over for det neutrofile
English: Before you inject Filgrastim ratiopharm you must do the following: Hold the syringe barrel and gently take the cover from the needle without twisting.
Danish: Sådan forbereder De indsprøjtningen af Filgrastim ratiopharm Før injektion af Filgrastim ratiopharm skal De foretage følgende: Hold i sprøjtecylinderen og træk forsigtigt beskyttelseshætten af kanylen uden at vride den. Hiv den ligeud som vist på figur 1 og 2.
English: The recommended starting dose of filgrastim is 0.1 MIU (1 μg)/kg/day given daily by subcutaneous injection with titration up to a maximum of 0.4 MIU (4 μg)/kg/day until a normal neutrophil count is reached and can be maintained (ANC > 2.0 x109/l).
Danish: Den anbefalede initialdosis filgrastim er 0,1 mio. IE (1 μg)/kg/døgn, der gives dagligt som subkutan injektion med optitrering til maksimalt 0,4 mio. IE (4 μg)/kg/døgn, indtil neutrofiltallet atter er normalt og kan fastholdes på dette niveau (ANC > 2,0 x109/l).
English: Infusion of PBPCs accelerates haematopoietic recovery reducing the duration of risk for haemorrhagic complications and
Danish: Infusion af PBPC accelererer hæmatopoietisk bedring med reduktion af varigheden for risiko for hæmoragiske komplikationer og behov for trombocyttransfusion.
English: Do not use it if the date has passed
Danish: Brug ikke sprøjten, hvis den sidste dato i den nævnte måned er overskredet.
English: Filgrastim ratiopharm is useful in several different conditions which are:
Danish: Filgrastim ratiopharm kan bruges ved følgende lidelser:
English: Sickle cells crises, in some cases fatal, have been reported with the use of filgrastim in subjects with sickle cell disease.
Danish: Der er rapporteret seglcellekriser, der kan være letale, ved brug af filgrastim hos patienter med seglcellesygdom.
English: Regular urinanalysis should be
Danish: Der bør udføres regelmæssige urinanalyser for at monitorere denne hændelse.
English: 6.6 Special precautions for disposal and other handling If required, Filgrastim ratiopharm may be diluted in glucose 50 mg/ml (5%) solution for infusion .
Danish: 6.6 Regler for destruktion og anden håndtering Filgrastim ratiopharm kan fortyndes efter behov med 50 mg/ml (5 %) glucose infusionsvæske.
English: Transient decreases in blood pressure, not requiring clinical treatment, have been reported
Danish: Der er lejlighedsvist rapporteret om forbigående, ikke behandlingskrævende blodtryksfald.
English: Special precautions in patients undergoing peripheral blood progenitor cell mobilisation
Danish: Særlige forsigtighedsregler hos patienter, der får foretaget mobilisering af perifere blodstamceller
English: However, during the period of administration of filgrastim for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leukocyte
Danish: Ved administration af filgrastim til perifer blodstamcellemobilisering skal filgrastim seponeres eller doseringen af filgrastim reduceres, hvis
English: Filgrastim ratiopharm and bone marrow transplantation The usual starting dose is 1 million international units (MIU) per kilogram of bodyweight each day.
Danish: Filgrastim ratiopharm og knoglemarvstransplantation Den sædvanlige startdosis er 1 million internationale enheder (mio. IE) pr. kg legemsvægt om dagen.
English: Type I glass pre-filled syringe with a permanently attached stainless steel needle.
Danish: Fyldt injektionssprøjte af type I-glas med fastmonteret kanyle af rustfrit stål.
English: The following undesirable effects and their frequencies have been observed under treatment with filgrastim based on published information.
Danish: Følgende bivirkninger med angivelse af hyppighed som observeret under behandling med filgrastim,
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen, hvis De bruger anden medicin eller har brugt det fornylig.
English: Component of a multipack comprising 2 packs, each containing 5 pre-filled syringes
Danish: Del af multipakke bestående af 2 pakker med 5 fyldte injektionssprøjter hver.
English: Elevated alkaline phosphatase, elevated LDH
Danish: Forhøjet basisk fosfatase, forhøjet LDH
English: Pulmonary infiltrates
Danish: Lungeinfiltrater
English: Filgrastim should not be administered to patients with severe congenital neutropenia (Kostman's syndrome) with abnormal cytogenetics (see below).
Danish: Filgrastim bør ikke gives til patienter med svær medfødt neutropeni (Kostmans syndrom) og anormal
English: Filgrastim has minor or moderate influence on the ability to drive and use machines.
Danish: 4.7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner Filgrastim påvirker i mindre eller ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Reduce to 0.5 MIU (5 µg)/kg/day
Danish: Justering af filgrastimdosis Reducer til 0,5 mio. IE (5 µg)/kg/døgn
English: For the mobilisation of PBPC in normal donors prior to allogeneic peripheral blood progenitor cell
Danish: Mobilisering af PBPC hos raske donorer før allogen perifer blodstamcelletransplantation
English: Filgrastim ratiopharm 48 MIU/0.8 ml: Each pre-filled syringe contains 48 million international units [MIU] (480 microgram) of filgrastim in 0.8 ml solution.
Danish: Filgrastim ratiopharm 48 mio. IE/0,8 ml: En fyldt injektionssprøjte indeholder 48 millioner internationale enheder [mio. IE] (480 mikrogram) filgrastim i 0,8 ml.
English: Following termination of filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 to 2 days, and to normal levels within 1 to 7 days.
Danish: Efter seponering af filgrastimbehandling falder det cirkulerende neutrofiltal med 50 % i løbet af 1-2 dage og
English: You will need to have regular blood tests whilst being treated with Filgrastim ratiopharm to count the number of neutrophils and other white blood cells in your blood.
Danish: Under behandlingen med Filgrastim ratiopharm skal De have regelmæssige blodprøver for at tælle antallet af hvide blodlegemer, blandt andet den type, der hedder neutrofilocytter.
English: Detailed information on this medicinal product is available on the website of the European Medicines
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.eu.int/
English: If you experience fatigue, do not drive or use any tools or machines.
Danish: De må ikke arbejde med værktøjer eller maskiner eller køre bil, hvis De føler Dem træt.
English: Special care should be taken when administering single or combination chemotherapeutic agents which are known to
Danish: Der bør udvises særlig forsigtighed ved administration af et enkelt kemoterapeutisk middel eller et kombinationspræparat, da de er kendt for at kunne medføre svær trombocytopeni.
English: Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia.
Danish: Det er særlig vigtigt at skelne mellem diagnoserne blasttransformation ved kronisk myeloid
English: Filgrastim ratiopharm and severe chronic neutropenia The usual starting dose is between 0.5 million and 1.2 million international units (MIU) per kilogram bodyweight each day in a single or divided dose.
Danish: Filgrastim ratiopharm og alvorlig lav mængde af hvide blodlegemer (kronisk neutropeni) Den sædvanlige startdosis er mellem 0,5 og 1,2 millioner internationale enheder (mio. IE) pr. kg legemsvægt hver dag som enkeltdosis eller fordelt på flere doser.
English: The recommended starting dose is 1.2 MIU (12 μg)/kg/day subcutaneously as a single dose or in
Danish: Den anbefalede initialdosis er 1,2 mio. IE (12 μg)/kg/døgn, der gives subkutant som enkeltdosis eller
English: Current data indicate that immunological interactions between the allogeneic PBPC graft and the recipient may be associated with an increased risk of acute and chronic GvHD when compared with
Danish: Særlige forsigtighedsregler hos recipienter af allogene PBPC mobiliseret med filgrastim Aktuelle data tyder på, at immunologiske interaktioner mellem et allogent transplantat af perifere blodstamceller og recipienten kan være forbundet med en øget risiko for akut og kronisk GvHD
English: Packs containing 1, 5 or 10 pre-filled syringes with 0.5 ml solution for injection or infusion or multipacks containing 10 (2 packs of 5) pre-filled syringes with 0.5 ml solution for injection or
Danish: Pakker indeholdende 1, 5 eller 10 fyldte injektionssprøjter med 0,5 ml injektions- eller infusionsvæske, opløsning eller multipakker indeholdende 10 (2 pakker á 5) fyldte injektionssprøjter med 0,5 ml injektions- eller infusionsvæske.
English: - if you get left upper abdominal pain or pain at the tip of your shoulder.
Danish: - Hvis De har seglcellesygdom, eller - Hvis De får ondt øverst til venstre i maven eller under skulderbladet.
English: - cough, fever and difficulty breathing or coughing up blood (frequency unknown) - feeling sick, vomiting, constipation, diarrhoea, loss of appetite, mucositis (painful inflammation and ulceration of the mucous membranes lining the digestive tract) - pains or difficulties in passing urine (very rare), blood in the urine, protein in the urine
Danish: - hoste, feber og åndedrætsbesvær eller ophosten af blod (hyppighed ukendt) - kvalme, opkastning, forstoppelse, diarré, appetitløshed, mucositis (smertefuld betændelse og
English: Long-term treatment with Filgrastim ratiopharm is required for neutropenia.
Danish: Det er nødvendigt at give langtidsbehandling mod neutropeni.
English: Thrombocytopenia
Danish: Leukocytose
English: If you use more Filgrastim ratiopharm than you should If you use more Filgrastim ratiopharm than you should, contact your doctor or pharmacist as soon as
Danish: Hvis De har taget for meget Filgrastim ratiopharm Kontakt lægen, skadestuen eller apoteket snarest muligt, hvis De har taget for meget Filgrastim
English: Elevated alkaline phosphatase, elevated LDH, elevated uric acid
Danish: Forhøjet basisk fosfatase, forhøjet LDH, forhøjet urinsyre
English: Packs containing 1, 5 or 10 pre-filled syringes with 0.8 ml solution for injection or infusion or multipacks containing 10 (2 packs of 5) pre-filled syringes with 0.8 ml solution for injection or
Danish: Pakker indeholdende 1, 5 eller 10 fyldte injektionssprøjter med 0,8 ml injektions- eller infusionsvæske, opløsning eller multipakker indeholdende 10 (2 pakker á 5) fyldte injektionssprøjter med 0,8 ml injektions- eller infusionsvæske.
English: Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 ml (60 MIU/ml, 600 microgram/ml).
Danish: En fyldt injektionssprøjte indeholder 30 millioner internationale enheder [mio. IE] (300 mikrogram) filgrastim i 0,5 ml (60 mio. IE/ml, 600 mikrogram/ml).
English: The recommended starting dose is 0.5 MIU (5 μg)/kg/day subcutaneously as a single dose or in
Danish: Den anbefalede initialdosis er 0,5 mio. IE (5 μg)/kg/døgn, der gives subkutant som enkeltdosis eller
English: Each pre-filled syringe contains 48 million international units [MIU] (480 microgram) of filgrastim in 0.8 ml (60 MIU/ml, 600 microgram/ml).
Danish: En fyldt injektionssprøjte indeholder 48 millioner internationale enheder [mio. IE] (480 mikrogram) filgrastim i 0,8 ml (60 mio. IE/ml, 600 mikrogram/ml).
English: Patients who have undergone very extensive prior myelosuppressive therapy may not show sufficient mobilisation of PBPC to achieve the recommended minimum yield (2.0 x 106 CD34+ cells/kg) or acceleration of platelet recovery to the same degree.
Danish: Patienter, som tidligere har fået meget omfattende myelosuppressiv kemoterapi, vil ikke altid opnå tilstrækkelig mobilisering af perifere blodstamceller til at opnå den anbefalede mindstehøst (2,0 x 106
English: If required, Filgrastim ratiopharm may be diluted in glucose 50 mg/ml (5%) solution for infusion.
Danish: Filgrastim ratiopharm kan fortyndes efter behov med 50 mg/ml (5 %) glucose infusionsvæske.
English: INFORMATION IN BRAILLE Filgrastim ratiopharm 48 MIU/0.8 ml
Danish: Filgrastim ratiopharm 48 mio. IE/0,8 ml
English: Transient, minor increases in alkaline phosphatase, LDH, SGOT (serum glutamic oxaloacetic transaminase) and uric acid have been reported in normal donors receiving filgrastim; these were
Danish: Forbigående, mindre stigninger i basisk fosfatase, LDH, ALAT (alaninaminotransferase) og urinsyre er rapporteret hos raske donorer, der fik filgrastim, men uden kliniske følger.
English: The assessment of undesirable effects is based on the following frequency data:
Danish: Bivirkningerne opdeles efter hyppighed som følger:
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: Er De i tvivl, så spørg lægen eller på
English: Accidental exposure to freezing temperatures does not adversely affect the stability of Filgrastim
Danish: Utilsigtet opbevaring ved temperaturer under frysepunktet skader ikke Filgrastim ratiopharms
English: Filgrastim ratiopharm 30 MIU/0.5 ml solution for injection or infusion Filgrastim ratiopharm 48 MIU/0.8 ml solution for injection or infusion
Danish: Filgrastim ratiopharm 30 mio. IE/0,5 ml injektions- og infusionsvæske, opløsning Filgrastim ratiopharm 48 mio. IE/0,8 ml injektions- og infusionsvæske, opløsning
English: Long-term administration may be required to maintain the ANC > 2.0 x 109/l.
Danish: For at opretholde et ANC > 2,0 x 109/l kan langtidsbehandling være nødvendig.
English: How do I prepare my Filgrastim ratiopharm injection?
Danish: Sådan injicerer De Filgrastim ratiopharm
English: Rheumatoid arthritis exacerbation Severe allergic reaction
Danish: Alvorlig allergisk reaktion
English: Each pre-filled syringe contains 30 MIU (300 µg) of filgrastim in 0.5 ml solution for injection or
Danish: En fyldt injektionssprøjte indeholder 30 mio. IE (300 µg) filgrastim i 0,5 ml injektions- og
English: In clinical studies, dosing with 30 MIU (300 μg)/day on 1 to 7 days per week was required to maintain the ANC
Danish: I kliniske forsøg var det nødvendigt at give 30 mio. IE (300 μg)/døgn i 1-7 dage om ugen for at opretholde ANC > 2,0 x 109/l, med en gennemsnitlig doseringshyppighed på 3 dage om ugen.
English: Constipation, anorexia, diarrhoea, mucositis Elevated GGT
Danish: Obstipation, anoreksi, diarré, mukosit
English: Undesirable effect
Danish: Bivirkninger
English: Alopecia, cutaneous vasculitis, injection site pain, rash Musculoskeletal pain Osteoporosis
Danish: Alopeci, hududslæt Sweets syndrom, kutan vaskulit Brystsmerter, muskuloskeletale smerter
English: reduction in blood platelets, which increases risk of bleeding or bruising, rise in white blood
Danish: - fald i antallet af røde blodlegemer, som kan give bleghed og svaghed eller åndenød; fald i antallet af blodplader, som øger risikoen for blødning eller buler; øget antal hvide blodlegemer.
English: Each pre-filled syringe contains 48 MIU (480 µg) of filgrastim in 0.8 ml solution for injection or
Danish: En fyldt injektionssprøjte indeholder 48 mio. IE (480 µg) filgrastim i 0,8 ml injektions- og
English: For infusions, filgrastim should be diluted in 20 ml of glucose 50 mg/ml (5%) solution for infusion (see section 6.6 for instructions on dilution).
Danish: Til infusioner skal filgrastim fortyndes med 20 ml af 50 mg/ml (5 %) glucose infusionsvæske (se fortyndingsvejledningen i pkt.
English: If you think you are having this type of reaction, stop your Filgrastim ratiopharm injection and get medical help immediately.
Danish: Stop omgående indsprøjtning af Filgrastim ratiopharm og søg lægehjælp, hvis De mener, at De oplever denne type reaktion.
English: Decreased glucose, elevated alkaline phosphatase, elevated LDH, hyperuricaemia
Danish: Anæmi, splenomegali Trombocytopeni Lidelser i milten Fald i blodglukose, forhøjet basisk fosfatase, forhøjet LDH, hyperurikæmi
English: What Filgrastim ratiopharm looks like and contents of the pack Filgrastim ratiopharm is a solution for injection or infusion in a pre-filled syringe.
Danish: Filgrastim ratiopharm er en injektions- og infusionsvæske i en fyldt injektionssprøjte.
English: Medicines should not be disposed of via wastewater or household waste.
Danish: - Brugte medicinsprøjter må ikke kasseres sammen med husholdningsaffaldet.
English: Rare pulmonary undesirable effects including interstitial pneumonia, pulmonary oedema and pulmonary infiltrates have been reported in some cases with an outcome of respiratory failure or adult respiratory distress syndrome (ARDS) which may be fatal (see section 4.4).
Danish: Der er rapporteret sjældne pulmonale bivirkninger, herunder interstitiel pneumoni, lungeødem og lungeinfiltrater, som i nogle tilfælde førte til respirationssvigt eller adult respiratory stress syndrome,
English: It could be a consequence of a spleen disorder (see section “4.
Danish: Det kan skyldes en lidelse i milten (se pkt.
English: TRM
Danish: BRM
English: If you stop using Filgrastim ratiopharm Before you stop using Filgrastim ratiopharm, talk to your doctor.
Danish: Hvis De holder op med at bruge Filgrastim ratiopharm
English: Water for injections
Danish: Sådan gives indsprøjtningen
English: Filgrastim should be diluted in 20 ml of glucose 50 mg/ml (5%) solution for infusion (see section 6.6 for instructions on dilution).
Danish: Filgrastim skal fortyndes med 20 ml 50 mg/ml (5 %) glucose infusionsvæske (se fortyndingsvejledningen i pkt.
English: The most commonly reported undesirable effect was mild to moderate transient musculo-skeletal pain.
Danish: Ved mobilisering af perifere blodstamceller hos raske donorer De hyppigst rapporterede bivirkninger var lette til moderate forbigående smerter i skeletmuskulaturen.
English: In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of Filgrastim ratiopharm is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Danish: 9/l og svære eller recidiverende infektioner i anamnesen er langtidsbehandling med Filgrastim ratiopharm indiceret for at øge neutrofiltallet og reducere forekomst og varighed af hændelser relateret til infektionen.
English: Normal donors are given a dose of a 10 μg/kg/day, administered subcutaneously for 4 to 5 consecutive days.
Danish: Raske donorer får en dosis på 10 μg/kg/døgn, som administreres
English: Each pre-filled syringe is for single use only.
Danish: Hver fyldt injektionssprøjte må kun bruges en enkelt gang.
English: Filgrastim should be permanently discontinued in patients who experience a serious allergic reaction.
Danish: Filgrastimbehandlingen skal seponeres permanent hos patienter, der
English: Medicinal product subject to medical prescription.
Danish: Det gælder også medicin, som ikke er købt på recept.
English: Special precautions in normal donors undergoing peripheral blood progenitor cell mobilisation
Danish: Særlige forsigtighedsregler hos raske donorer, der får foretaget mobilisering af perifere