FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy, Lonquex should be administered approximately 24 hours after administration of cytotoxic chemotherapy.
Danish: I betragtning af den mulige følsomhed af de hurtigt delende myeloide celler over for cytotoksisk kemoterapi, bør Lonquex administreres ca. 24 timer efter administration af cytotoksisk kemoterapi.
English: The injections should be given into the abdomen, upper arm or thigh.
Danish: Injektionerne bør gives i abdomen, på overarmen eller i låret.
English: Thrombocytopenia and leukocytosis have been reported (see section 4.4).
Danish: Trombocytopeni og leukocytose er blevet rapporteret (se pkt.
English: Regular monitoring of the platelet count and haematocrit is recommended.
Danish: Regelmæssig kontrol af trombocyttallet og hæmatokrit anbefales.
English: Lonquex contains the active substance lipegfilgrastim.
Danish: Lonquex indeholder det aktive stof lipegfilgrastim.
English: Your doctor will also check your urine regularly as other medicines similar to this one (e.g. other granulocyte colony stimulating factors such as filgrastim, lenograstim or pegfilgrastim) can possibly harm the tiny filters inside your kidneys (glomerulonephritis; see section “4.
Danish: Din læge vil også kontrollere din urin regelmæssigt, da andre lægemidler, der ligner dette (f.eks. andre granulocyt-kolonistimulerende faktorer, såsom filgrastim, lenograstim eller pegfilgrastim) muligvis kan beskadige de bittesmå filtre i dine nyrer (glomerulonefritis, se punkt 4 ”Bivirkninger”).
English: Pull straight as shown in pictures 2 and 3.
Danish: Træk lige ud som vist på figur 2 og 3.
English: 0.121 to 1.260
Danish: 0,121 til 1,260
English: • Musculoskeletal pains such as bone pain and pain in the joints, muscles, limbs, chest, neck or back.
Danish: • Knogle- og muskelsmerter, såsom knoglesmerter og smerter i leddene, musklerne, arme og ben, brystet, halsen eller ryggen.
English: • Cough, fever and difficult or painful breathing can be signs of uncommon serious pulmonary side effects, such as pneumonia and acute respiratory distress syndrome, which may be fatal.
Danish: • Hoste, feber og besværlig eller smertefuld vejrtrækning kan være tegn på ikke almindelige alvorlige lungebivirkninger, såsom lungebetændelse og akut lungesvigtsyndrom, som kan være dødeligt.
English: The linear pathway is likely due to extracellular protein degradation by neutrophil elastase and other plasma proteases.
Danish: Den linære rute er sandsynlig på grund af ekstracellulær proteindegradation af neutrofil elastase og andre plasmaproteaser.
English: EU/1/13/856/001 1 pre-filled syringe with safety device EU/1/13/856/002 1 pre-filled syringe
Danish: EU/1/13/856/001 1 fyldt injektionssprøjte med sikkerhedsanordning EU/1/13/856/002 1 fyldt injektionssprøjte
English: Pre-filled syringe (type I glass) with a plunger stopper [poly(ethylene-co-tetrafluoroethylene)-coated bromobutyl rubber] and a fixed injection needle (stainless steel, 29G [0.34 mm] or 27G [0.4 mm] x 0.5 inch [12.7 mm]).
Danish: Fyldt injektionssprøjte (type I-glas) med en stempelprop [poly(ethylen-co-tetrafluorethylen)-belagt brombutylgummi] og en fast kanyle (rustfrit stål, 29G [0,34 mm] eller 27G [0,4 mm] x 0,5 tommer [12,7 mm]).
English: A WBC count should be performed at regular intervals during therapy owing to the clinical effects of lipegfilgrastim and the potential for leukocytosis.
Danish: En kontrol af WBC bør udføres med regelmæssige intervaller i løbet af behandlingen på grund af lipegfilgrastims kliniske virkninger og muligheden for leukocytose.
English: 0.206 to 0.512
Danish: 0,206 til 0,512
English: Patients with myeloid leukaemia or myelodysplastic syndromes
Danish: Patienter med myeloid leukæmi eller myelodysplastiske syndromer
English: For patients with increased risk on hypokalaemia due to underling disease or co-medications, it is recommended to monitor the serum potassium level carefully and to substitute potassium if necessary.
Danish: Hos patienter med øget risiko for hypokaliæmi pga, underliggende sygdom eller samtidigt lægemiddel anbefales det at monitorere serum-kalium nøje og om nødvendigt give kaliumtilskud.
English: Press the injection site with a piece of gauze bandage or a sterile gauze swab for several seconds.
Danish: Tryk ned på injektionsstedet med et stykke gazebind eller en steril gazeserviet i flere sekunder.
English: For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature (not above 25°C) or hold the pre-filled syringe gently in your hand for a few minutes.
Danish: For at gøre injektionen mere bekvem bør du lade den fyldte injektionssprøjte nå til stuetemperatur ved at vente i 30 minutter (ikke ved temperaturer over 25 °C), eller du kan forsigtigt holde den fyldte injektionssprøjte i hånden i nogle få minutter.
English: Pull straight as shown in pictures 1 and 2.
Danish: Træk lige ud som vist på figur 1 og 2.
English: Figure 1: Profile of median serum concentration of lipegfilgrastim and median ANC in chemotherapy-treated patients after a single 6 mg injection of lipegfilgrastim
Danish: Figur 1: Profil af median serumkoncentration af lipegfilgrastim og median ANC hos kemoterapibehandlede patienter efter en enkelt 6 mg injektion af lipegfilgrastim
English: Your doctor has prescribed Lonquex for you in order to reduce the duration of a condition called neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever).
Danish: Din læge har ordineret Lonquex til dig for at reducere varigheden af en tilstand, der kaldes neutropeni (lavt antal hvide blodlegemer) og forekomsten af febril neutropeni (lavt antal hvide blodlegemer med feber).
English: If you use more Lonquex than you should, talk to your doctor.
Danish: Hvis du har brugt for meget Lonquex, skal du tale med lægen.
English: Lipegfilgrastim appears to be mainly eliminated by neutrophil-mediated clearance, which becomes saturated at higher doses.
Danish: Det ser ud som om lipegfilgrastim primært elimineres via en neutrofilmedieret clearance, som mættes ved højere doser.
English: -0.461 to 0.089
Danish: -0,461 til 0,089
English: Splenomegaly, generally asymptomatic, has been reported (see section 4.4).
Danish: Splenomegali, normalt asymptomatisk, er blevet rapporteret (se pkt.
English: Hypersensitivity reactions*
Danish: Overfølsomhedsreaktioner*
English: Currently available data are described in section 5.2, but no recommendation on a posology can be made.
Danish: 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: Reversible, mild to moderate elevations in alkaline phosphatase and lactate dehydrogenase may occur, with no associated clinical effects.
Danish: Reversible, lette til moderate forhøjelser i basisk fosfatase og lactatdehydrogenase kan forekomme, uden forbundne kliniske virkninger.
English: Increased risk of disease progression or death was not observed with lipegfilgrastim.
Danish: Der blev ikke observeret en øget risiko for sygdomsprogression eller død med lipegfilgrastim.
English: Hypokalaemia*
Danish: Hypokaliæmi*
English: The study showed non-inferiority of 6 mg lipegfilgrastim to 6 mg pegfilgrastim for the primary endpoint, duration of severe neutropenia (DSN) in the first cycle of chemotherapy (see table 2).
Danish: Studiet viste non-inferioritet af 6 mg lipegfilgrastim i forhold til 6 mg pegfilgrastim for det primære endepunkt, varighed af svær neutropeni (DSN) i den første kemoterapicyklus (se tabel 2).
English: Skin and subcutaneous tissue disorders - Acute febrile neutrophilic dermatosis (Sweet's syndrome) - Cutaneous vasculitis
Danish: Hud og subkutane væv - Akut febril neutrofil dermatose (Sweets syndrom) - Kutan vaskulitis.
English: The mean terminal half-lives were approximately 29 and 31 hours after a single subcutaneous injection of 6 mg lipegfilgrastim during the first cycle of chemotherapy.
Danish: De gennemsnitlige terminale halveringstider var ca. 29 og 31 timer efter en enkelt subkutan injektion af 6 mg lipegfilgrastim i løbet af den første cyklus af kemoterapi.
English: • Low blood levels of potassium, which can cause muscle weakness, twitching or abnormal heart rhythm.
Danish: • Lavt niveau af kalium i blodet, hvilket kan forårsage muskelsvaghed, trækninger eller unormal hjerterytme.
English: Consistent with a self-regulating clearance mechanism, the serum concentration of lipegfilgrastim declines slowly during the chemotherapy-induced transient neutrophil nadir and rapidly at the following onset of neutrophil recovery (see figure 1).
Danish: I overensstemmelse med en selvregulerende clearancemekanisme falder serumkoncentrationen af lipegfilgrastim langsomt under kemoterapi-induceret forbigående neutrofilnadir, og hurtigt under den følgende forbedring af neutrofiltallet (se figur 1).
English: 2031 GA Haarlem Netherlands
Danish: 2031 GA Haarlem Holland
English: Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8).
Danish: Patienter, der udvikler symptomer på kapillærlækage-syndrom, skal monitoreres nøje og have symptomatisk standardbehandling, inklusive eventuel intensiv behandling (se pkt.
English: • an alcohol wipe,
Danish: • en spritserviet,
English: Do not use any Lonquex that is left in the syringe.
Danish: Brug ikke tiloversbleven Lonquex i sprøjten.
English: Sodium hydroxide (for pH-adjustment) Sorbitol (E420)
Danish: Koncentreret eddikesyre Natriumhydroxid (til justering af pH) Sorbitol (E420)
English: Blood alkaline phosphatase increased*, Blood lactate dehydrogenase increased*
Danish: Forhøjet basisk fosfatase i blodet*, forhøjet lactatdehydrogenase i blodet*
English: • Allergic reactions such as skin rash, raised itchy areas of skin and serious allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported uncommonly (may affect up to 1 in 100 people).
Danish: • Allergiske reaktioner som hududslæt, kløende hævede hudområder og alvorlige allergiske reaktioner med svaghed, blodtryksfald, vejrtrækningsbesvær og hævelse af ansigt er blevet rapporteret med en hyppighed på ikke almindelig (kan forekomme hos op til 1 ud af 100 personer).
English: Treatment-related adverse events were back pain, bone pain and increased neutrophil count (1 event each).
Danish: Behandlingsrelaterede bivirkninger var rygsmerter, knoglesmerter og forhøjet neutrofiltal (1 tilfælde hver).
English: Special care should be taken when administering single or combination chemotherapeutic medicinal products that are known to cause severe thrombocytopenia.
Danish: Der bør udvises særlig forsigtighed ved administration af et enkelt kemoterapi-lægemiddel eller et kombinationspræparat, som er kendte for at kunne medføre svær trombocytopeni.
English: Incidence (%) Odds ratio 95 % CI
Danish: Forekomst (%) Odds ratio 95 % CI
English: Capillary leak syndrome has been reported after administration of G-CSF or derivatives and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
Danish: Der er indberettet kapillærlækage-syndrom efter administration af G-CSF eller derivater, kendetegnet ved hypotension, hypoalbuminæmi, ødem og hæmokoncentration.
English: With the syringe pointing upwards, expel all air from the syringe by pushing the plunger slowly upwards.
Danish: Mens sprøjten peger opad, fjernes al luften fra sprøjten ved langsomt at skubbe stemplet opad.
English: Lipegfilgrastim is internalised by neutrophils (non-linear process), then degraded within the cell by endogenous proteolytic enzymes.
Danish: Lipegfilgrastim optages i neutrofiler (ikke lineær process) og degraderes dernæst i cellen af endogene proteolytiske enzymer.
English: Odds ratio (lipegfilgrastim / placebo), CI and p-value out of multivariate logistic regression analysis
Danish: Odds ratio (lipegfilgrastim/placebo), CI og p-værdi ud af multivariat logistisk regressionsanalyse
English: After injecting the liquid, remove the needle and let go of your skin.
Danish: Efter væsken injiceres, fjernes kanylen, og du kan slippe huden.
English: In the case of overdose, WBC and platelet count should be performed regularly and spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Danish: I tilfælde af en overdosering skal der tages kontroller af WBC og trombocyttal regelmæssigt, og miltstørrelsen bør monitoreres nøje (f.eks. ved klinisk undersøgelse, ultralyd).
English: There is no experience with overdose of lipegfilgrastim.
Danish: Der er ingen erfaring med en overdosis af lipegfilgrastim.
English: • if you are allergic to lipegfilgrastim or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for lipegfilgrastim eller et af de øvrige indholdsstoffer i Lonquex (angivet i punkt 6).
English: You will need to give yourself the injection into the tissue just under the skin.
Danish: Du skal give dig selv injektionen i væv lige under huden.
English: The safety and efficacy of Lonquex have not been investigated in patients receiving high dose chemotherapy.
Danish: Lonquex' sikkerhed og virkning er ikke blevet undersøgt hos patienter, der får højdosis kemoterapi.
English: Lipegfilgrastim is a covalent conjugate of filgrastim with a single methoxy polyethylene glycol (PEG) molecule via a carbohydrate linker consisting of glycine, N-acetylneuraminic acid and N-acetylgalactosamine.
Danish: Lipegfilgrastim er et kovalent konjugat af filgrastim med et enkelt methoxypolyethylenglycol (PEG)molekyle via en kulhydratlinker bestående af glycin, N-acetylneuraminsyre og N-acetylgalactosamin.
English: Concomitant use of lipegfilgrastim with any chemotherapeutic medicinal product has not been evaluated in patients.
Danish: Samtidig brug af lipegfilgrastim og kemoterapeutika er ikke blevet evalueret hos patienter.
English: Lonquex is indicated in adults for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Danish: Lonquez er indiceret til voksne til reduktion af varigheden af neutropeni og forekomsten af febril neutropeni hos patienter i behandling med cytotoksisk kemoterapi for malignitet (med undtagelse af kronisk myeloid leukæmi og myelodysplastiske syndromer).
English: To give yourself an injection into the tissue under the skin you will need:
Danish: For at give dig selv en injektion i vævet under huden, skal du bruge:
English: Thrombocytopenia*
Danish: Trombocytopeni*
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim, lenograstim or pegfilgrastim.
Danish: Generelt gik hændelserne med glomerulonefritis væk efter dosisreduktion eller seponering af filgrastim, lenograstim eller pegfilgrastim.
English: • Rise in white blood cells.
Danish: • Øget antal hvide blodlegemer.
English: Injection site reactions such as injection site induration and injection site pain may occur.
Danish: Reaktioner på injektionsstedet som induration og smerter på injektionsstedet kan forekomme.
English: This medicine should be given approximately 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
Danish: Dette lægemiddel gives ca. 24 timer efter din sidste dosis kemoterapi, ved slutningen af hver kemoterapicyklus.
English: • Sickle cell crises in patients with sickle cell anaemia.
Danish: • Seglcellekriser hos patienter med seglcelleanæmi.
English: • Never put the syringes that you have used into your normal household rubbish bin.
Danish: • Brugte sprøjter må aldrig smides i affaldsspande til normalt husholdningsaffald.
English: Patients were randomised 2:1 to receive either 6 mg lipegfilgrastim or placebo.
Danish: Patienterne blev randomiseret i forholdet 2:1 til at få enten 6 mg lipegfilgrastim eller placebo.
English: Once-per-cycle dosing of lipegfilgrastim was investigated in two pivotal randomised, double-blind clinical studies in patients undergoing myelosuppressive chemotherapy.
Danish: Dosering af lipegfilgrastim én gang pr. cyklus blev undersøgt i to pivotale randomiserede, dobbeltblinde kliniske studier hos patienter, der gennemgik myelosuppressiv kemoterapi.
English: Filgrastim is an un-glycosylated recombinant methionyl human G-CSF.
Danish: Filgrastim er et ikke-glykosyleret rekombinant methionyl humant G-CSF.
English: This medicine contains 30 mg sorbitol in each pre-filled syringe.
Danish: Dette lægemiddel indeholder 30 mg sorbitol i hver fyldt injektionssprøjte.
English: If you forget to use Lonquex
Danish: Hvis du har glemt at bruge Lonquex
English: Glomerulonephritis has been reported in patients receiving filgrastim, lenograstim or pegfilgrastim.
Danish: Der er blevet rapporteret glomerulonefritis hos patienter, der fik filgrastim, lenograstim eller pegfilgrastim.
English: This medicine is given as an injection using a pre-filled syringe.
Danish: Dette lægemiddel gives som en injektion med en fyldt injektionssprøjte.
English: Breast-feeding should be discontinued during treatment with Lonquex.
Danish: Amning skal ophøre under behandling med Lonquex.
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the pre-filled syringe after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på yderkartonen og på etiketten for den fyldte injektionssprøjte efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Lipegfilgrastim is metabolised via intra- or extracellular degradation by proteolytic enzymes.
Danish: Lipegfilgrastim metaboliseres via intra- eller ekstracellulær degradation af proteolytiske enzymer.
English: Contents of the pack and other information What Lonquex contains
Danish: Pakningsstørrelser og yderligere oplysninger Lonquex indeholder:
English: The onset of pulmonary symptoms such as cough, fever and dyspnoea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function together with an increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS) (see section 4.8).
Danish: Debut af lungesymptomer som hoste, feber og dyspnø i forbindelse med radiologiske fund af lungeinfiltrater og forværring af lungefunktionen sammen med et øget neutrofiltal kan være tidlige tegn på akut lungesvigtsyndrom (acute respiratory distress syndrome, ARDS) (se pkt.
English: Vascular disorders - Capillary leak syndrome Cases of capillary leak syndrome have been reported in postmarketing experience after administration of G-CSF or derivatives.
Danish: Vaskulære sygdomme - Kapillærlækage-syndrom Der er indberettet tilfælde af kapillærlækage-syndrom efter administration af G-CSF eller derivater efter markedsføring.
English: Most serious side effects
Danish: De alvorligste bivirkninger
English: A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain.
Danish: Diagnosen miltruptur bør overvejes hos patienter, der klager over smerter i venstre side af øvre abdomen eller under skulderbladet.
English: What you need to know before you use Lonquex Do not use Lonquex:
Danish: Det skal du vide, før du begynder at bruge Lonquex Brug ikke Lonquex:
English: Pulmonary adverse reactions*, Pulmonary Haemorrhage
Danish: Pulmonale bivirkninger*, pulmonal blødning
English: These have generally occurred in patients suffering from advanced malignant diseases, having sepsis, taking multiple chemotherapy medicinal products or undergoing apheresis (see section 4.4).
Danish: Generelt er disse tilfælde set hos patienter med fremskreden malign sygdom, sepsis, der får flere kemoterapeutika, eller som har gennemgået aferese (se pkt.
English: A post-authorisation safety study XM22-ONC-40041 was conducted to collect data of disease progression and mortality in patients with advanced squamous or non-squamous cell lung cancer receiving lipegfilgrastim in addition to the platinum-based chemotherapy.
Danish: Efter markedsføringstilladelsen blev der udført et sikkerhedsstudie, XM22-ONC-40041, for at indsamle data for sygdomsprogression og mortalitet hos patienter med fremskreden planocellulær eller ikke-planocellulær lungecancer, der fik lipegfilgrastim i tillæg til platinbaseret kemoterapi.
English: What the recommended dose is
Danish: Anbefalet dosis
English: These pulmonary adverse reactions may also include pulmonary oedema, pulmonary infiltrates, pulmonary fibrosis, respiratory failure or ARDS (see section 4.4).
Danish: Disse pulmonale bivirkninger kan også omfatte lungeødem, lungeinfiltrater, lungefibrose, åndedrætssvigt eller ARDS (se pkt.
English: The active substance is a covalent conjugate of filgrastim** with methoxy polyethylene glycol (PEG) via a carbohydrate linker.
Danish: Det aktive stof er et kovalent konjugat af filgrastim** med methoxypolyethylenglycol (PEG) via en kulhydratlinker.
English: Open the blister and take the pre-filled syringe out of the blister (see picture 1).
Danish: Åbn blisteret og tag den fyldte injektionssprøjte ud af blisteret (se figur 1).
English: Mean ± SD (d) Δ LS mean 95 % CI
Danish: Gennemsnit ± SD (d) Δ LS gennemsnit 95 % CI
English: No neutralising antibodies against lipegfilgrastim were observed.
Danish: Der blev ikke observeret nogen neutraliserende antistoffer mod lipegfilgrastim.
English: You will normally inject your dose of Lonquex approximately 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
Danish: Du vil normalt injicere din dosis Lonquex ca. 24 timer efter din sidste dosis kemoterapi, og ved slutningen af hver kemoterapicyklus.
English: One 6 mg dose of lipegfilgrastim (a single pre-filled syringe of Lonquex) is recommended for each chemotherapy cycle, given approximately 24 hours after cytotoxic chemotherapy.
Danish: En 6 mg dosis af lipegfilgrastim (en enkelt fyldt injektionssprøjte med Lonquex) anbefales for hver kemoterapicyklus, og gives ca. 24 timer efter cytotoksisk kemoterapi.
English: Merckle GmbH, Graf-Arco-Straße 3 89079 Ulm Germany
Danish: Merckle GmbH Graf-Arco-Straße 3 89079 Ulm Tyskland
English: After a single subcutaneous injection of 6 mg lipegfilgrastim during the fourth cycle, the maximum blood concentrations were lower than observed in the first cycle (mean values 77 and 111 ng/ml) and were reached after median tmax of 8 hours.
Danish: Efter en enkelt subkutan injektion af 6 mg lipegfilgrastim i løbet af den fjerde cyklus, var de maksimale koncentrationer i blodet lavere end observeret i den første cyklus (gennemsnitlige værdier 77 og 111 ng/ml), og de blev nået efter en median tmax på 8 timer.
English: If someone else is injecting you, they can also use the back and side of your upper arms (see grey areas in pictures 5 and 6).
Danish: Hvis injektionen gives af en anden, kan den også gives bag på og på siden af armene (se de grå områder på figur 5 og 6).
English: - Aortitis (see section 4.4)
Danish: - Aortitis (se pkt.
English: Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely with other medicines like this one (e.g. filgrastim, lenograstim or pegfilgrastim of the group of G-CSFs).
Danish: Der er indberettet sjældne tilfælde af betændelse i aorta (den store pulsåre, der transporterer blod fra hjertet ud i kroppen) med andre tilsvarende lægemidler (f.eks. filgrastim, lenograstim eller pegfilgrastim i gruppen G-CSF'er).
English: Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia.
Danish: Det er særligt vigtigt at skelne mellem diagnoserne blasttransformation ved kronisk myeloid leukæmi og akut myeloid leukæmi.
English: Due to the neutrophil-mediated clearance mechanism, the pharmacokinetics of lipegfilgrastim is not expected to be affected by renal or hepatic impairment.
Danish: Grundet den neutrofilmedierede clearancemekanisme forventes lipegfilgrastim ikke at påvirkes af nedsat nyre- eller leverfunktion.