FrancophonIA/ELRC3.0 huggingface dataset:
English: Premature discontinuation of filgrastim therapy, prior to the time of the expected neutrophil nadir, is not recommended.
Danish: Det anbefales ikke at stoppe behandlingen med filgrastim før, tidspunktet for det forventede neutrofile nadir er nået.
English: Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
Danish: Der er ikke foretaget kliniske studier om eventuelle interaktioner med andre hæmatopoietiske vækstfaktorer og cytokiner.
English: Nivestim 30 MU/0.5 ml
Danish: Nivestim 30 ME/ 0,5 ml
English: Special precautions in SCN patients
Danish: Særlige forholdsregler hos patienter med SCN
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: Ved gentagne rutineundersøgelser blev der senere fundet abnormaliteter, herunder monosomi 7, hos en undergruppe på ca. 12 % af de patienter, som havde normal cytogenetik ved baseline.
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 10
Danish: Patienter, som tidligere har fået omfattende myelosuppressiv kemoterapi, vil ikke altid opnå tilstrækkelig mobilisering af PBPC til at opnå den anbefalede minimumshøst (≥ 2,0 x 10 6/CD34 + celler/kg) eller den anbefalede acceleration i øgningen af trombocytter.
English: Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive chemotherapy.
Danish: Behandling med filgrastim alene forhindrer ikke trombocytopeni og anæmi fremkaldt af myelosuppressiv kemoterapi.
English: The first dose of filgrastim should be administered at least 24 hours following cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.
Danish: Den første filgrastimdosis bør gives mindst 24 timer efter den cytotoksiske kemoterapi og mindst 24 timer efter knoglemarvsinfusionen.
English: Special precautions in sickle cell trait and sickle cell disease
Danish: Særlige forsigtighedsregler ved seglcelletræk og seglcelleanæmi
English: • swelling and/or fluid in the lungs (pulmonary oedema)
Danish: • Hævelse og/eller væske i lungerne (lungeødem)
English: Some cases of splenic rupture were fatal (see section 4.4).
Danish: I nogle tilfælde var miltruptur dødeligt (se pkt.
English: • severe pain in the bones, chest, gut or joints (sickle cell anaemia with crisis)
Danish: • Kraftige smerter i knogler, bryst, mave-tarm-kanalen eller led (seglcellekrise)
English: The stem cells will then go back into the bone marrow and produce blood cells; - to increase the number of white blood cells if you suffer from severe chronic neutropenia to help prevent infections; - in patients with advanced HIV infection which will help reduce the risk of infections.
Danish: - til at øge antallet af hvide blodlegemer, hvis du lider af svær kronisk neutropeni for at hjælpe med at forhindre infektion - til patienter med fremskreden hiv-infektion for at hjælpe med at mindske risikoen for infektion.
English: Idiopathic or cyclic neutropenia: the recommended starting dose is 0.5 MU (5 µg)/kg/day as a single dose or in divided doses.
Danish: Idiopatisk eller cyklisk neutropeni: Den anbefalede startdosis er 0,5 ME (5 µg)/kg/dag.
English: Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive medications.
Danish: Behandling med filgrastim alene forhindrer ikke trombocytopeni og anæmi fremkaldt af den myelosuppressive behandling.
English: If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.
Danish: Hvis du har flere spørgsmål om dette produkt, skal du kontakte din læge, sygeplejersken eller apoteket.
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: • A sharps container (puncture proof container) for disposing of used syringes safely.
Danish: • En beholder, som ikke kan punkteres til sikker bortskaffelse af brugte sprøjter
English: Example: In a final injection volume of 20 ml, total doses of filgrastim less than 30 MU (300 g) should be given with 0.2 ml of 200 mg/ml (20%) human albumin solution added.
Danish: Eksempel: Hvis det endelige volumen er 20 ml, bør totaldoser af filgrastim på mindre end 30 ME (300 µg) gives med tilsætning af 0,2 ml 200 mg/ml human serumalbuminopløsning (20 %).
English: Epistaxis
Danish: Epistaksi
English: • inflammation of the lungs (interstitial lung disease)
Danish: • Inflammation af lungerne (interstitiel lungesygdom)
English: There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section c).
Danish: Der er indberettet GvHD og dødsfald hos patienter efter allogen knoglemarvstransplantation (se afsnit c).
English: What Nivestim contains
Danish: Nivestim indeholder:
English: Following induction and consolidation treatment for acute myeloid leukaemia the duration of treatment may be substantially longer (up to 38 days) depending on the type, dose and schedule of cytotoxic chemotherapy used.
Danish: Behandlingsvarigheden kan være væsentlig længere (op til 38 dage) efter induktion og konsoliderende behandling for akut myeloid leukæmi afhængig af hvilken cytotoksisk kemoterapi og hvilket doseringsskema, der bruges.
English: Assessment of progenitor cell yields
Danish: Vurdering af udbyttet af progenitorceller
English: Dysuria Haematuria
Danish: Dysuri Hæmaturi
English: Special care should be taken when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia.
Danish: Der skal iagttages særlig forsigtighed, når der gives kemoterapeutiske stoffer, som er kendt for at forårsage svær trombocytopeni, som enkeltstof eller i kombination.
English: Filgrastim acts primarily on neutrophil precursors to exert its effect in elevating neutrophil counts.
Danish: Filgrastim virker primært på neutrofile prækursorer.
English: There is no evidence that patients with HIV infection treated with filgrastim show an increase in HIV replication.
Danish: Der er ikke tegn på øget HIV-replikation hos patienter i filgrastimbehandling.
English: • bleeding from the lung (pulmonary haemorrhage)
Danish: • Blødning fra lungerne (pulmonal hæmoragi)
English: In normal stem cell donors, an increase in white blood cells (leucocytosis) and a decrease of platelets may be seen.
Danish: Hos raske stamcelledonorer kan der observeres en stigning i antallet af hvide blodlegemer (leukocytose) og et fald i antal blodplader, hvilket nedsætter blodets evne til at størkne (thrombocytopeni).
English: Tabulated summary of adverse reactions
Danish: Tabelinddelt resumé af bivirkninger
English: Neutrophils produced in response to filgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Danish: De neutrofile blodlegemer, som er dannet som respons på filgrastim, viser normal eller forstærket funktion.
English: Acetic acid, glacial Sodium hydroxide Sorbitol (E420) Polysorbate 80
Danish: Natriumhydroxid Sorbitol (E420) Polysorbat 80
English: Data from clinical studies in paediatric patients indicate that the safety and efficacy of filgrastim are similar in both adults and children receiving cytotoxic chemotherapy.
Danish: Data fra de kliniske studier hos børn tyder på, at filgrastims sikkerhed og effekt er ens hos voksne og børn, som får cytotoksisk kemoterapi.
English: Filgrastim should be diluted in 20 ml of 5% glucose solution (see section 6.6).
Danish: Filgrastim skal fortyndes i 20 ml 5 % glucoseopløsning (se pkt.
English: For the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation
Danish: Mobilisering af PBPC'er hos raske donorer før allogen transplantation af PBPC
English: Oropharyngeal pain a,e
Danish: Orofaryngeale smerter a,e
English: • urinary tract infection
Danish: • Urinvejsinfektion
English: The recommended dose of filgrastim is 0.5 MU (5 µg)/kg/day.
Danish: Den anbefalede filgrastimdosis er 0,5 ME (5 µg)/kg/dag.
English: Hypersensitivity-type reactions including anaphylaxis, rash, urticaria, angioedema, dyspnoea and hypotension occurring on initial or subsequent treatment have been reported in clinical studies and in post-marketing experience.
Danish: Der er i kliniske forsøg og efter markedsføring af produktet rapporteret om overfølsomhedslignende reaktioner, herunder anafylaksi, udslæt, urticaria, angioødem, dyspnø og hypotension, der opstod ved første behandling eller efterfølgende behandlinger.
English: Since lithium promotes the release of neutrophils, lithium is likely to potentiate the effect of filgrastim.
Danish: Lithium øger sandsynligvis filgrastims virkning, da det øger frigivelsen af neutrofile granulocytter.
English: added.
Danish: indgift.
English: Pre-filled syringe (type I glass), with injection needle (stainless steel) with a needle guard, containing 0.5 ml solution for injection/infusion
Danish: Fyldt sprøjte (type I glas) med kanyle (rustfrit stål) med kanylebeskytter, som indeholder 0,5 ml opløsning til injektion/infusion.
English: The recommended dose of filgrastim for PBPC mobilisation when used alone is 1.0 MU (10 µg)/kg/day for 5 to 7 consecutive days.
Danish: Den anbefalede filgrastimdosis til PBPC-mobilisering er 1,0 ME (10 µg)/kg/dag, i 5 til 7 konsekutive dage.
English: Special precautions in normal donors undergoing PBPC mobilisation
Danish: Særlige forholdsregler hos raske donorer, som får foretaget mobilisering af PBPC
English: In some SCN patients filgrastim can also induce a minor increase in the number of circulating eosinophils and basophils relative to baseline; some of these patients may present with eosinophilia or basophilia already prior to treatment.
Danish: Hos nogle patienter med SCN kan filgrastim også inducere en mindre øgning af antallet af cirkulerende eosinofile og basofile hvide blodlegemer i forhold til udgangsværdierne.
English: Pre-filled syringe (type I glass), with injection needle (stainless steel) with a needle guard, containing 0.2 ml solution for injection/infusion.
Danish: Fyldt sprøjte (type I glas) med kanyle (rustfrit stål) med kanylebeskytter, som indeholder 0,2 ml opløsning til injektion-/infusion.
English: Slowly push down the plunger until all the contents of the syringe have been emptied.
Danish: Tryk langsomt stemplet ned, indtil sprøjten er tom.
English: In clinical studies, dosing with
Danish: I de kliniske studier var det nødvendigt at give 30
English: The recommended starting dose of filgrastim is 1.0 MU (10 µg)/kg/day.
Danish: Den anbefalede initialdosis af filgrastim er 1,0 ME (10 µg)/kg/dag.
English: • bone density decreased
Danish: • Formindsket knogletæthed
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Vomiting a,e
Danish: Opkastning a,e
English: • have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing as these could be signs of a severe allergic reaction (hypersensitivity).
Danish: Fortæl det straks til lægen under behandling med Nivestim, hvis du: - får pludselige tegn på allergi, såsom udslæt, kløe eller nældefeber på huden, hævelse i ansigt, læber, tunge eller andre dele af kroppen, stakåndethed, hvæsende vejrtrækning eller vejrtrækningsbesvær, da det kan være tegn på en alvorlig allergisk reaktion (overfølsomhed).
English: Hyperuricaemia Blood uric acid increased
Danish: Hyperurikæmi Forhøjet urinsyre i blodet
English: Use of Active UltraSafe Needle Guard for Nivestim 12 MU/0.2 ml solution for injection/infusion
Danish: Brug af aktiv kanylebeskytter til Nivestim 12 ME/0,2 ml injektions-/infusionsvæske, opløsning
English: Regular monitoring of platelet count and haematocrit is recommended.
Danish: Det anbefales at monitorere trombocyttallet og hæmatokritværdien regelmæssigt.
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 scheduled dosing with filgrastim.
Danish: Det anbefales at tage blodprøver til bestemmelse af ANC umiddelbart før, der gives en ny filgrastimdosis for at kontrollere patientens trough og nadir ANC.
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrationssted et
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om Nivestim findes på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: For infusions filgrastim should be diluted in 20 ml of 5% glucose solution (see section 6.6).
Danish: Ved infusion skal filgrastim fortyndes i 20 ml 5 % glucose-opløsning (se pkt.
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 et separat, retrospektivt internationalt studie med patienter med akutte og kroniske myelogene leukæmier, blev der ikke observeret nogen virkning på risikoen for GvHD, BRM og mortalitet.Der blev ikke påvist nogen virkning på risikoen for akut GvHD, kronisk GvHD eller tidlig behandlingsrelateret mortalitet i en metaanalyse af allogene transplantationsstudier, som omfattede resultaterne fra ni prospektive randomiserede studier, otte retrospektive studier og et case-kontrolleret studie.
English: Splenomegaly and splenic rupture
Danish: Splenomegali Lavt hæmoglobin
English: • pain when passing urine (dysuria)
Danish: • Smerter ved vandladning (dysuri)
English: Hold the syringe with the needle pointing upwards.
Danish: Hold sprøjten med kanylen opad.
English: There are reports in the literature where the transplacental passage of filgrastim in pregnant women has been demonstrated.
Danish: Der er rapporter i litteraturen, som har påvist, at filgrastim passerer placenta.
English: Patients with a recent history of lung infiltrates or pneumonia may be at higher risk.
Danish: Risikoen kan være højere hos patienter, som tidligere har haft lungeinfiltrater eller pneumoni.
English: Respiratory failure a
Danish: Transfusionsreaktion a
English: Paediatric use in the SCN and cancer settings
Danish: Børn med SCN og cancer
English: 1 pre-filled syringe with 0.2 ml.
Danish: 1 fyldt sprøjte med 0,2 ml.
English: • inflammation of the lung (bronchitis)
Danish: • Betændelse i lungerne (bronkitis)
English: - if you get left upper belly (abdominal) pain, pain below the left rib cage or pain at the tip of your shoulder, as there may be a problem with your spleen (enlargement of the spleen (splenomegaly) or rupture of the spleen).
Danish: - hvis du får smerter i øverste venstre del af maven, smerter under brystkassen i venstre side eller yderst på skulderen, da der kan være et problem med din milt (forstørret milt (splenomegali) eller milten kan briste) - hvis du er i behandling for svær kronisk neutropeni og du har blod i urinen (hæmaturi).
English: Remove the Nivestim syringe from the fridge and allow it to reach room temperature (approximately 25 C).
Danish: Foretag indsprøjtningen på omtrent samme tid hver dag Tag Nivestim sprøjten ud af køleskabet og lad den stå i 15 - 30 minutter, indtil den har nået stuetemperatur (ca. 25 C).
English: The pre-filled syringe has an UltraSafe Needle Guard attached in order to protect from needle stick injury.
Danish: Den fyldte sprøjte er forsynet med en kanylebeskytter, som skal forhindre nålestiksskader.
English: Diarrhoea a,e
Danish: Mave-tarm-kanalen Diarré a,e
English: How to use Nivestim
Danish: Sådan skal du bruge Nivestim
English: Needle guard is attached to the pre-filled syringe in order to protect from needle stick injury.
Danish: Den fyldte sprøjte er forsynet med en beskyttelseshætte for at beskytte kanylen mod stikskader.
English: In patients receiving cytotoxic chemotherapy, a transient increase in neutrophil counts is typically seen 1 to 2 days after initiation of filgrastim therapy.
Danish: Der blev typisk set en forbigående stigning i neutrofiltallet 1-2 dage efter, at behandlingen med filgrastim var påbegyndt hos de patienter, som fik cytotoksisk kemoterapi.
English: Kidney injury has been seen in patients who received filgrastim.
Danish: Der er set nyreskade hos patienter, der får filgrastim.
English: Blood lactate dehydrogenase increased
Danish: Nedsat appetit Forhøjet lactatdehydrogenase i blodet
English: Sickle cell anaemia with crisis
Danish: Miltruptur Seglcelleanæmi med seglcellekrise
English: Congenital neutropenia: the recommended starting dose is 1.2 MU (12 µg)/kg/day as a single dose or in divided doses.
Danish: Medfødt neutropeni: Den anbefalede startdosis er 1,2 ME (12 µg)/kg/dag.
English: The clinical relevance of this finding to multiple dose administration is not clear.
Danish: administration af flere doser er ikke klarlagt.
English: Dizziness Hypoaesthesia Paraesthesia
Danish: Svimmelhed Hypoæstesi Paræstesi
English: • nausea
Danish: • Kvalme
English: Rare side effects (may affect up to 1 in 1,000 people):
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer)
English: Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain.
Danish: Inkluderer knoglesmerter, rygsmerter, artralgi, myalgi, smerter i ekstremiteter, muskel- og knoglesmerter, muskel- og knoglesmerter i brystet, nakkesmerter.
English: • constipation
Danish: • Træthed
English: If you use more Nivestim than you should
Danish: Hvis du har brugt for meget Nivestim
English: Remove the protective cap from the injection needle.
Danish: Træk kanylen ud af huden efter indsprøjtningen.
English: Dilution to a final concentration less than 0.2 MU (2 µg) per ml is not recommended at any time.
Danish: Nivestim bør ikke fortyndes til en slutkoncentration under 0,2 mio E (2 µg) pr. ml.
English: Upper respiratory tract infection
Danish: Infektion i øvre luftvejUrinvejsinfek tion
English: Nivestim 48 MU/0.5 ml solution for injection/infusion Each ml of solution for injection or infusion contains 96 million units [MU] (960 micrograms [µg]) of filgrastim*.
Danish: Nivestim 48 ME/0,5 ml injektions-/infusionsvæske, opløsning Hver ml injektions- eller infusionsvæske indeholder 96 mio enheder [ME] (960 mikrogram [µg]) filgrastim*.
English: • Nivestim 48 MU/0.5 ml solution for injection/infusion: each pre-filled syringe contains 48 million units (MU), 480 g of filgrastim in 0.5 ml (corresponding to 0.96 mg/ml).
Danish: - Nivestim 48 ME/0,5 ml injektions-/infusionsvæske, hver fyldt sprøjte indeholder 48 millioner enheder (ME), 480 µg filgrastim i 0,5 ml (det svarer til 0,96 mg/ml).
English: When handling the pre-filled syringe, keep hands behind the needle.
Danish: Hold hænderne bag kanylen, når du skal bruge den fyldte sprøjte.
English: • upper respiratory tract infection
Danish: • Infektion i de øvre luftveje
English: 9/L) following filgrastim administration and leukapheresis was observed in 35% of subjects studied.
Danish: 9/l) hos 35 % af donorerne efter filigrastimbehandling og leukaferese (se pkt.
English: • Nivestim 12 MU/0.2 ml solution for injection/infusion: each pre-filled syringe contains 12 million units (MU), 120 g of filgrastim in 0.2 ml (corresponding to 0.6 mg/ml).
Danish: - Nivestim 12 ME/0,2 ml injektions-/infusionsvæske, hver fyldt sprøjte indeholder 12 millioner enheder (ME), 120 µg filgrastim i 0,2 ml (det svarer til 0,6 mg/ml).
English: a Analysis includes studies involving BM transplant during this period; some studies used GM-CSF.
Danish: I nogle studier blev der brugt GM-CSF.
English: (Chondrocalcinosis Pyrophosphate) Fluid volume disturbances
Danish: Nedsat blodglucose Pseudopodagra (chondrocalcino se pyrophosphat) Forstyrrelser i væskebalancen
English: Thrombocytopenia Anaemia e
Danish: Blod og lymfesystem Trombocytopeni Anæmi
English: Nivestim 12 MU/0.2 ml solution for injection/infusion Each ml of solution for injection or infusion contains 60 million units [MU] (600 micrograms [µg]) of filgrastim*.
Danish: Nivestim 12 ME/0,2 ml injektions-/infusionsvæske, opløsning Hver ml opløsning til injektion eller infusion indeholder 60 millioner enheder [ME] (600 mikrogram [µg]) filgrastim*.
English: Thrombocytopenia has been reported in patients receiving filgrastim.
Danish: Der er indberettet trombocytopeni hos patienter, der får filgrastim.
English: Keep this medicine out of the sight and reach of children.
Danish: Opbevares dette lægemiddel utilgængeligt for børn.
English: Neutrophil count
Danish: Neutrofiltal
English: Information on self administration by the patient
Danish: Information om, hvordan patienten giver sig selv en indsprøjtning
English: There have been reports of graft versus host disease (GvHD) and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see sections 4.8 and 5.1).
Danish: Der er indberettet tilfælde af graft versus host sygdom (GvHD) og dødsfald blandt patienter, der fik G-CSF efter allogen knoglemarvstransplantation (se pkt.
English: After injecting the solution remove the needle from the skin.
Danish: Træk kanylen ud af huden.
English: • Nivestim 30 MU/0.5 ml solution for injection/infusion: each pre-filled syringe contains 30 million units (MU), 300 g of filgrastim in 0.5 ml (corresponding to 0.6 mg/ml).
Danish: - Nivestim 30 ME/0,5 ml injektions-/infusionsvæske, hver fyldt sprøjte indeholder 30 millioner enheder (ME), 300 µg filgrastim i 0,5 ml (det svarer til 0,6 mg/ml).
English: Pre-filled syringe
Danish: Fyldte sprøjter
English: • dizziness
Danish: • Udslæt
English: Each pre-filled syringe contains 48 million units (MU) (480 micrograms [µg]) of filgrastim in 0.5 ml (0.96 mg/ml).
Danish: Hver fyldt sprøjte indeholder 48 mio enheder (ME) (480 mikrogram [µg]) filgrastim i 0,5 ml (0,96 mg/ml).
English: What Nivestim is and what it is used for What you need to know before you use Nivestim How to use Nivestim
Danish: Det skal du vide, før du begynder at bruge Nivestim Sådan skal du bruge Nivestim Bivirkninger
English: Each pre-filled syringe contains 48 million units (MU) (480 g) of filgrastim in 0.5 ml (0.96 mg/ml)
Danish: Hver fyldt sprøjte indeholder 48 mio enheder (ME) (480 µg) filgrastim i 0,5 ml (0,96 mg/ml)
English: Blood cell counts
Danish: Blodcelletal
English: Nivestim 30 MU/0.5 ml solution for injection/infusion Each ml of solution for injection or infusion contains 60 million units [MU] (600 micrograms [µg]) of filgrastim*.
Danish: Nivestim 30 ME/0,5 ml injektions-/infusionsvæske, opløsning Hver ml injektions- eller infusionsvæske indeholder 60 mio enheder [ME] (600 mikrogram [µg]) filgrastim*.
English: Check with your doctor, nurse or pharmacist if you are not sure.
Danish: • Spørg lægen, apoteketspersonalet eller sygeplejersken, hvis der er mere, du vil vide.
English: Posology
Danish: Publikation
English: See package leaflet for direction for use of the needle safe device.
Danish: Se indlægssedlen vedrørende vejledning i brugen af hætten.
English: Use of UltraSafe Passive Needle Guard for Nivestim 30 MU/0.5 ml solution for injection/infusion and Nivestim 48 MU/0.5 ml solution for injection/infusion
Danish: Brug af passiv kanylebeskytter til Nivestim 30 ME/0,5 ml ml injektions-/infusionsvæske, opløsning og Nivestim 48 ME/0,5 ml injektions-/infusionsvæske, opløsning
English: • nose bleeds (epistaxis)
Danish: • Næseblod (epistaksi)
English: There have been reports of GvHD and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see sections 4.4 and 5.1).
Danish: Der har været rapporter om GvHD og fataliteter hos patienter, der fik G-CSF efter allogen knoglemarvstransplantation (se pkt.