FrancophonIA/ELRC3.0 huggingface dataset:
English: There are insufficient data to evaluate Accofil use in geriatric subjects for other approved Accofil indications.
Danish: Der er ikke tilstrækkelige data til at vurdere brug af Accofil til geriatriske patienter hvad angår andre godkendte indikationer for Accofil.
English: Take your Accofil pre-filled syringe out of the refrigerator.
Danish: Tag medicinsprøjten med Accofil ud af køleskabet.
English: Before you inject Accofil you must do the following:
Danish: Før injektion af Accofil skal du gøre følgende:
English: A risk to the breastfeeding child cannot be excluded.
Danish: En risiko for ammede barn kan ikke udelukkes.
English: In pregnant rats, no maternal or fetal toxicity was observed at doses up to 575 µg/kg/day.
Danish: Hos drægtige rotter blev der ikke observeret nogen maternel eller føtal toksicitet i doser på op til 575 µg/kg/dag.
English: Statistical analysis of the relationship between the number of CD34+ cells re-infused and the rate of platelet recovery after high-dose chemotherapy indicates a complex but continuous relationship.
Danish: Den statistiske analyse af forholdet mellem antallet af reinfunderede CD34+ celler og hastigheden af gendannelsen af trombocytter efter højdosis kemoterapi tyder på en kompleks men kontinuerlig relation.
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: Filgrastims sikkerhed og virkning hos de novo AML-patienter, som er < 55 år, og som har god cytogenetik [t (8; 21), t (15; 17), og inv (16)] er ikke klarlagt.
English: Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk.
Danish: Patienter med en nylig anamnese med lungeinfiltrater eller pneumoni kan have en højere risiko.
English: G-CSF can promote growth of myeloid cells in vitro and similar effects may be seen on some nonmyeloid cells in vitro.
Danish: G-CSF kan fremme væksten af myeloide celler in vitro og lignende virkning kan ses på nogle nonmyeloide celler in vitro.
English: For further instructions on dilution prior to infusion see section 6.6.
Danish: For yderligere vejledning vedrørende fortynding før infusion se punkt 6.6.
English: For maintenance of normal neutrophil counts
Danish: Vedligeholdelse af normalt neutrofiltal
English: It is unknown whether filgrastim or its metabolites are excreted in human milk.
Danish: Det er ukendt, om filgrastim/metabolitter udskilles i human mælk.
English: The data in the tables below describe adverse reactions reported from clinical trials and spontaneous reporting.
Danish: Data i tabellerne herunder beskriver bivirkninger rapporteret fra kliniske forsøg og spontane rapporter.
English: Leukapheresis should be performed during the period when the ANC rises from < 0.5 x 109/L to > 5.0 x 109/L.
Danish: Der bør udføres leukaferese i den periode, hvor ANC stiger fra < 0,5 x 109/l til > 5,0 x 109/l.
English: Middlesex, HA1 4HF United Kingdom
Danish: Middlesex HA1 4HF, Storbritannien
English: Always use Accofil exactly as your doctor has told you.
Danish: Brug altid Accofil nøjagtigt efter lægens anvisning.
English: Filgrastim dosing should be maintained until the last leukapheresis.
Danish: Filgrastimdoseringen skal fortsætte indtil den sidste leukaferese.
English: Haematuria was common and proteinuria occurred in a small number of patients.
Danish: Hæmaturi var almindelig, og proteinuri forekom hos et lille antal patienter.
English: If required, Accofil may be diluted in 5% glucose.
Danish: Hvis påkrævet kan Accofil fortyndes i 5 % glucose.
English: Accofil does not contain any preservative.
Danish: Accofil indeholder ingen konserveringsmidler.
English: You will need to give yourself the injection into the tissue just under the skin.
Danish: Du skal give indsprøjtningen i væv lige under huden.
English: 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: Kemisk og fysisk stabilitet af den fortyndede infusionsvæske er påvist i 24 timer ved 2 °C-8 °C.
English: Accofil treatment will last for up to 2 weeks.
Danish: Accofil behandlingen vil fortsætte i op til 2 uger.
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, medmindre fortynding er foretaget under kontrollerede og validerede aseptiske forhold.
English: Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Danish: Filgrastrim må ikke anvendes til at forhøje dosis af cytotoksisk kemoterapi ud over de etablerede dosisregimer.
English: These could be symptoms of a condition called “sepsis” (also called "blood poisoning"), a severe infection with whole-body inflammatory response which can be life threatening and needs urgent medical attention.
Danish: Disse kan være symptomer på en tilstand kaldet blodforgiftning (også kaldet "sepsis"), hvilket er en alvorlig infektion med betændelsesreaktion i hele kroppen, der kan være livstruende og kræver akut lægehjælp.
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 posology recommendations cannot be made.
Danish: I kliniske forsøg med filgrastim indgik et mindre antal ældre patienter, men særlige undersøgelser er ikke udført i denne gruppe, og derfor kan specifikke anbefalinger vedrørende dosering ikke gives.
English: Rates of generation of antibodies against filgrastim is generally low.
Danish: Hyppigheden af antistofdannelse mod filgrastim er generelt lav.
English: Other special precautions Causes of transient neutropenia such as viral infections should be excluded.
Danish: Årsager til forbigående neutropeni, som f.eks. virusinfektioner, skal udelukkes.
English: Special precautions in patients with acute myeloid leukaemia (AML)
Danish: Særlige forsigtighedsregler hos patienter med akut myeloid leukæmi (AML)
English: What Accofil is used for
Danish: Hvad Accofil bruges til
English: During long term use cutaneous vasculitis has been reported in 2% of SCN patients.
Danish: Ved langvarig brug er der indberettet kutan vaskulitis hos 2 % af SCN-patienterne.
English: Continuous infusion with Accofil over a period of up to 28 days, in patients recovering from autologous bone-marrow transplantation, resulted in no evidence of drug accumulation and comparable half-lives.
Danish: Kontinuerlig infusion af Accofil i en periode på op til 28 døgn til patienter, som restituerer efter autolog knoglemarvstransplantation, resulterede i intet tegn på akkumulation og sammenlignelige halveringstider.
English: If you use more Accofil than you should, contact your doctor or pharmacist as soon as possible.
Danish: Hvis du har brugt mere Accofil, end du skal, skal du kontakte din læge eller apotekspersonale så hurtigt som muligt.
English: It is unknown whether filgrastim passes over into the breast milk.
Danish: Det er uvist, om filgrastim passerer over i modermælken.
English: In randomised clinical trials, a subcutaneous dose of 230 microgram/m2/day (4.0 to 8.4 microgram/kg/day) was used.
Danish: I randomiserede kliniske studier blev en subkutan dosis på 230 mikrogram/m2/dag (4,0 til 8,4 mikrogram/kg/dag) anvendt.
English: Your doctor may then test your blood to see how well your treatment with Accofil is working and to find the dose that is best for you.
Danish: Din læge kan derefter teste dit blod for at se, hvor godt behandlingen med Accofil fungerer, og for at finde den dosis, der er bedst for dig.
English: The efficacy of the treatment was clear for this age group, which included most patients with congenital neutropenia.
Danish: Der var en klar behandlingseffekt hos patienter i denne aldersgruppe, hvoraf flertallet havde medfødt neutropeni.
English: Within each frequency grouping undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne opstillet efter faldende alvorlighed.
English: In clinical studies, 97% of patients who responded had a complete response at doses of ≤ 24 µg/kg/day.
Danish: I kliniske studier havde 97 % af de patienter, der responderede, komplet respons efter doser ≤ 24 µg/kg/dag.
English: Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 106 CD34+ cells/kg recipient bodyweight.
Danish: Leukaferese skal startes på dag 5 og fortsættes indtil dag 6, om nødvendigt, for at indsamle 4 x 106 CD34+ celler/kg af modtagerens legemsvægt.
English: Accofil containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Danish: Accofil, som indeholder r-metHuG-CSF (filgrastim) forårsager signifikante stigninger af neutrofiltallet i perifert blod inden for 24 timer med mindre stigninger af monocyttallet.
English: PBPC mobilisation should be considered only in donors who meet normal clinical and laboratory eligibility criteria for stem cell donation.
Danish: Mobilisering af PBPC må kun udføres hos donorer, der opfylder normale kliniske og laboratoriemæssige egnethedskriterier for stamcelledonation.
English: Accofil therapy should only be given in collaboration with an oncology centre which has experience in granulocyte-colony stimulating factor (G-CSF) treatment and haematology and has the necessary diagnostic facilities.
Danish: Der må kun gives behandling med Accofil i samarbejde med et onkologisk center, som har erfaring med behandling med granulocytkolonistimulerende faktor (G-CSF), og som også har hæmatologisk erfaring og de nødvendige diagnostiske faciliteter.
English: It is better to change the injection site every day to avoid the risk of soreness at any one site.
Danish: Det er bedst at give indsprøjtningen et nyt sted hver dag for at nedsætte risikoen for ømhed ved injektionsstedet.
English: Therefore, filgrastim is not indicated for use in these conditions.
Danish: Derfor er filgrastim ikke indiceret ved disse sygdomme.
English: When diluted in 5% glucose, Accofil is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Danish: Ved fortynding i 5 % glucose er Accofil forligeligt med glas og en række plasttyper, herunder PVC, polyolefin (en co-polymer af polypropylen og polyethylen) og polypropylen.
English: Physicians should exercise caution when considering the use of filgrastim in patients with sickle cell trait or sickle cell disease and only after careful evaluation of the potential risks and benefits.
Danish: Læger skal udvise forsigtighed, når de overvejer at behandle med filgrastim hos patienter med seglcelletræk eller seglcellesygdom, og dette bør kun finde sted efter nøje afvejning af mulige risici og fordele.
English: A very frequent side effect of Accofil use is pain in your muscles or bones (musculoskeletal pain), which can be helped by taking standard pain relief medicines (analgesics).
Danish: En meget hyppig bivirkning under brug af Accofil er smerter i dine muskler eller knogler (muskel- og ledsmerter), som kan afhjælpes ved at tage smertestillende lægemidler (analgetika).
English: Once the neutrophil nadir has been passed, the daily dose of filgrastim should be titrated against the neutrophil response as follows:
Danish: Når det neutrofile nadir er passeret, skal den daglige filgrastimdosis titreres i forhold til det neutrofile respons, som følger:
English: If exposure has been greater than 24 hours or frozen more than once then Accofil should NOT be used.
Danish: Hvis eksponeringen overstiger 24 timer, eller hvis opløsningen fryses mere end en gang, må Accofil IKKE anvendes.
English: Very rare: < 1/10,000
Danish: Meget sjælden: < 1/10.000
English: Do not touch the needle or push the plunger.
Danish: Undgå at berøre kanylen og at skubbe til stemplet.
English: Mobilization of PBPC
Danish: Mobilisering af PBPC
English: Accofil must not be diluted with sodium chloride solutions.
Danish: Accofil må ikke fortyndes med natriumchlorid opløsninger.
English: Among these, two cases of platelets < 50 x 109/L were reported and attributed to the leukapheresis procedure.
Danish: Blandt disse blev der indberettet to tilfælde af trombocyttal < 50 x 109/l, som var relateret til leukafereseproceduren.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 18.09.2014
Danish: Dato for første markedsføringstilladelse: 18.09.2014 Dato for seneste fornyelse:
English: Filgrastim should be discontinued and appropriate treatment given in these cases.
Danish: I disse tilfælde skal filgrastim seponeres og en passende behandling gives.
English: Adverse reactions Very common Common Uncommon Rare
Danish: Bivirkninger Meget almindelig Almindelig Ikke almindelig
English: Check again to make sure the correct dose of Accofil is in the syringe.
Danish: Tjek en ekstra gang for at sikre, at sprøjten indeholder den korrekte dosis Accofil.
English: If you develop or are likely to develop cancers of the blood, you should not use Accofil, unless instructed by your doctor.
Danish: Hvis du udvikler kræft i blodet, eller det er sandsynligt, at du vil gøre det, må du kun anvende Accofil efter lægens anvisning.
English: Very common: ≥ 1/10
Danish: Meget almindelig: ≥ 1/10
English: Accofil may have a minor influence on your ability to drive and use machines.
Danish: Accofil kan have en mindre indvirkning på din evne til at køre bil eller håndtere maskiner.
English: The frequency is estimated as uncommon from clinical trial data.
Danish: Hyppigheden skønnes at være ikke almindelig baseret på kliniske forsøgsdata.
English: In normal donors, a 10 micrograms/kg/day dose administered subcutaneously for 4 - 5 consecutive days allows a collection of ≥ 4 x 106 CD34+ cells/kg recipient body weight in the majority of the donors after two leukaphereses.
Danish: Hos normale donorer muliggør en dosis på 10 mikrogram/kg/dag administreret subkutant i 4-5 på hinanden følgende dage en indsamling af ≥ 4 x 106 CD34+ celler/kg af modtagerens kropsvægt hos de fleste donorer efter to leukafereser.
English: It is important to tell your doctor if you: • are pregnant or breast-feeding;
Danish: Det er vigtigt, at du meddeler lægen, hvis du: - er gravid eller ammer - tror at du måske er gravid, eller - planlægger at blive gravid
English: Cases of Sweets syndrome (acute febrile dermatosis) have been reported in the post-marketing setting.
Danish: Tilfælde af Sweets syndrom (akut febril dermatose) er blevet indberettet efter markedsføring.
English: Accofil contains sorbitol and sodium
Danish: Accofil indeholder sorbitol og natrium
English: How Accofil is given
Danish: Hvordan Accofil gives
English: Filgrastim should be administered daily by subcutaneous injection until the neutrophil count has reached and can be maintained at more than 1.5 x 109/L.
Danish: Filgrastim skal gives dagligt som subkutan injektion, indtil neutrofiltallet er nået og kan opretholdes på mere end 1,5 x 109/l.
English: Within its shelf-life and for the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 15 days.
Danish: Inden for opbevaringstiden og ved ambulant brug kan patienterne tage lægemidlet ud af køleskabet og opbevare det ved stuetemperatur (ikke over 25°C) i en enkelt periode på op til 15 dage.
English: In case of suspected or confirmed pulmonary adverse events, discontinuation of treatment with filgrastim should be considered and appropriate medical care given.
Danish: I tilfælde af mistanke om eller bekræftet pulmonale bivirkninger, bør seponering af behandlingen med filgrastim overvejes og passende medicinsk behandling gives.
English: Hypersensitivity-type reactions including anaphylaxis, rash, urticaria, angioedema, dyspnoea and hypotension occurred on initial or subsequent treatment in clinical studies and in post-marketing experience.
Danish: Overfølsomhed-lignende reaktioner, inklusive anafylaksi, udslæt, urticaria, angioødem, dyspnø og hypotension forekom ved den initiale eller efterfølgende behandling i kliniske studier og efter markedsføring.
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 bone marrow transplantation.
Danish: De nuværende data tyder på, at immunologiske interaktioner mellem det allogene PBPC-transplantat og modtageren kan være forbundet med en øget risiko for akut eller kronisk graft versus host-sygdom (GvHD), når der sammenlignes med en knoglemarvstransplantation.
English: Acute respiratory distress syndromea
Danish: Akut respiratorisk distress syndroma
English: Your treatment with Accofil will usually last for about 14 days.
Danish: Din behandling med Accofil vil normalt vare i ca 14 dage.
English: This medicine also contains sodium less than 1mmol sodium (0.035 mg) per dose, i.e. essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol (0,035 mg) pr. dosis, dvs. den er i det væsentlige natriumfri.
English: If you see blood in the syringe, remove the needle and re-insert it in another place.
Danish: Hvis du kan se blod i sprøjten, skal du fjerne kanylen og stikke den ind et andet sted.
English: Accofil contains sorbitol (E420) as an excipient at a concentration of 50 mg/ml.
Danish: Accofil indeholder sorbitol (E420) som et hjælpestof med en koncentration på 50 mg/ml.
English: Talk to your doctor, pharmacist or nurse before using Accofil:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Accofil:
English: Pharmacotherapeutic group: immunostimulants, colony stimulating factors, ATC code: L03AA02 Accofil is a biosimilar medicinal product.
Danish: Farmakoterapeutisk klassifikation: Immunstimulerende midler, kolonistimulerende faktorer, ATC-kode: L03AA02
English: j. Inject only the dose your doctor has told you following the instructions below.
Danish: Injicer kun den dosis, som lægen har ordineret, og følg instruktionerne nedenfor.
English: Dilution to a final concentration less than 0.2 MU (2 µg) per ml is not recommended at any time.
Danish: Fortynding til en slutkoncentration mindre end 0,2 mill (2 mikrogram) pr. ml anbefales ikke på noget tidspunkt.
English: Dizziness may occur following the administration of Accofil (see section 4.8).
Danish: Der kan opstå svimmelhed efter administration af Accofil (se pkt.
English: Accofil contains the active ingredient filgrastim.
Danish: Accofil indeholder det aktive stof filgrastim.
English: Offspring of rats administered filgrastim during the peri-natal and lactation periods, exhibited a delay in external differentiation and growth retardation (≥20 µg/kg/day) and slightly reduced survival rate (100
Danish: Afkom af rotter, der fik filgrastim administreret i den perinatale periode og i laktationsperioden, udviste forsinkelse i ekstern differentiering og væksthæmning (≥20 µg/kg/dag) og let nedsat overlevelsesrate (100 µg/kg/dag).
English: Accofil may have a minor influence on the ability to drive and use machines.
Danish: Accofil kan have en mindre påvirkning på evnen til at føre motorkøretøj eller betjene maskiner.
English: Common but generally asymptomatic cases of splenomegaly and uncommon cases of splenic rupture have been reported in healthy donors and patients following administration of G-CSFs.
Danish: Der er indberettet om almindeligt forekommende, men generelt asymptomatiske tilfælde af splenomegali og om meget sjældne tilfælde af miltruptur hos raske donorer og hos patienter efter administration af G-CSF.
English: The onset of pulmonary signs such as cough, fever and dyspnoea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function may be preliminary signs of Adult Respiratory Distress Syndrome (ARDS).
Danish: Lyngesymptomer som f.eks. hoste, feber og dyspnø i forbindelse med radiologiske tegn på lungeinfiltrater og forværring af lungefunktionen kan være tidlige tegn på Adult Respiratory Distress Syndrome (ARDS).
English: Cases of capillary leak syndrome have been reported in the post marketing setting with granulocyte colony-stimulating factor use.
Danish: Tilfælde af kapillær lækagesyndrom er blevet indberettet efter markedsføring ved brug af granulocytkoloni-stimulerende faktor.
English: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration.
Danish: Der er blevet indberettet pulmonale bivirkninger, særligt interstitiel pneumoni, efter administration af G-CSF.
English: Some cytotoxic agents exhibit particular toxicities to the haematopoietic progenitor pool and may adversely affect progenitor mobilisation.
Danish: Visse cytostatika er særligt toksiske over for den hæmatopoietiske progenitorpool, og kan have en negativ virkning på mobilisering af progenitorceller.
English: Intravenous (80 µg/kg/day) administration of filgrastim to rabbits during the period of organogenesis was maternally toxic and increased spontaneous abortion, post-implantation loss, and decreased mean live litter size and fetal weight were observed.
Danish: Intravenøs administration (80 µg/kg/dag) af filgrastim til kaniner under organogenese var toksisk for moderen, og der blev observeret øget spontan abort, tab efter implantation og reduceret gennemsnitlig levende kuldstørrelse og fostervægt.
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 kapillær lækagesyndrom bør monitoreres nøje og have standard symptomatisk behandling, som kan omfatte behov for intensiv pleje (se pkt.
English: The volume of distribution in blood is approximately 150ml/kg.
Danish: Fordelingsvolumen i blodet er ca. 150 ml/kg.
English: If you stop using Accofil
Danish: Hvis du holder op med at bruge Accofil
English: The no observed adverse effect level for embryo-fetal toxicity in this study was 10 µg/kg/day, which corresponded to a systemic exposure of approximately 3-5 times the exposures observed in patients treated with the clinical dose.
Danish: NOAEL (no observed adverse effect level) for embryoføtal toksicitet i dette studie var 10 µg/kg/dag, hvilket svarede til en systemisk eksponering på ca. 3-5 gange de eksponeringer, der ses hos patienter, som behandles med den kliniske dosis.
English: Ensure the needle cover remains on the syringe until just before you are ready to inject.
Danish: Sørg for, at kanylehætten forbliver på sprøjten, lige indtil du er klar til at tage injektionen.
English: Put the used syringe in the disposal container.
Danish: Anbring den brugte sprøjte i en affaldsbeholder.
English: If the ANC decreases to < 1.0 x 109/L during the treatment period, the dose of filgrastim should be re-escalated according to the above steps
Danish: Hvis ANC falder til < 1,0 x 109/l under behandlingen, skal filgrastimdosis igen øges i henhold til ovenstående skema
English: Your doctor may test your blood at regular intervals to see how well the Accofil treatment is working.
Danish: Din læge kan tage blodprøver med jævne mellemrum for at se, hvor godt Accofil behandlingen virker.
English: In clinical studies, more than 90% of patients responded at these doses, achieving a reversal of neutropenia in a median of 2 days.
Danish: I kliniske studier, responderede mere end 90 % af patienterne på disse doser og opnåede en revertering af neutropeni på 2 dage (median).