FrancophonIA/ELRC3.0 huggingface dataset:
English: Ratiograstim 30 MIU/0.5 mL solution for injection/ infusion Ratiograstim 48 MIU/0.8 mL solution for injection/infusion
Danish: Ratiograstim 30 mio. IE/0,5 ml injektions-/infusionsvæske, opløsning Ratiograstim 48 mio. IE/0,8 ml injektions-/infusionsvæske, opløsning
English: Infections and
Danish: Infektioner og parasitære sygdomme
English: Prior to allogeneic PBPC transplantation, use of filgrastim for the mobilisation of PBPC in normal donors allows a collection of ≥ 4 x 10
Danish: Behandling med filgrastim før allogen PBPC-transplantation til mobilisering af PBPC hos raske donorer gør det muligt at høste ≥ 4 x 106 CD34+-celler/kg legemsvægt hos recipienten hos de fleste af donorerne efter to leukafereser.
English: Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Danish: Indehaver af markedsføringstilladelsen ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Tyskland
English: Drug hypersensiti vitya
Danish: Lægemiddel overfølsom heda
English: - sickle cell anaemia, as this medicine may cause sickle cell crisis - osteoporosis (bone disease).
Danish: Fortæl det til lægen, inden De starter på behandlingen, hvis De har - seglcelleanæmi, da dette lægemiddel kan forårsage seglcellekrise - osteoporose (knoglesygdom).
English: Transient thrombocytopenia (platelets < 100 x 109/L) following filgrastim administration and leukapheresis was observed in 35 % of subjects studied.
Danish: Efter administration af filgrastim og leukaferese blev der set forbigående trombocytopeni (trombocyttal < 100 x 109/l) hos 35 % af donorerne.
English: Ratiograstim 48 MIU/0.8 mL solution for injection/ infusion Filgrastim
Danish: Ratiograstim 48 mio. IE/0,8 ml injektions-/infusionsvæske, opløsning Filgrastim
English: Astheniaa Malaisee Oedema peripherale
Danish: Smertera Astenia Utilpashede Perifert ødeme
English: The use of filgrastim mobilised PBPCs has been shown to reduce the depth and duration of thrombocytopenia following myelosuppressive or myeloablative chemotherapy.
Danish: Det har vist sig, at sværhedsgraden og varigheden af trombocytopeni efter myelosuppressiv eller myeloablativ kemoterapi nedsættes ved brug af PBPC, som er mobiliseret af filgrastim.
English: Cutaneous vasculitisa
Danish: Kutan vaskulitis
English: In patients undergoing a stem cell or bone marrow transplant, Graft versus host disease (GvHD) may occur- this is a reaction of the donor cells against the patient receiving the transplant; signs and symptoms include rash on the palms of your hands or soles of your feet and ulcer and sores in your mouth, gut, liver, skin, or your eyes, lungs, vagina and joints.
Danish: Tegn og symptomer omfatter udslæt i håndfladerne eller under fødderne og sår i munden, tarmene, leveren, huden eller i øjne, lunger, skede og led.
English: Splenic rupturea Sickle cell anaemia with crisisa
Danish: Miltruptura Seglcellean æmi med seglcellekris ea
English: What Ratiograstim is and what it is used for What you need to know before you use Ratiograstim How to use Ratiograstim
Danish: Det skal De vide, før De begynder at bruge Ratiograstim Sådan skal De bruge Ratiograstim Bivirkninger
English: Ratiograstim 30 MIU/0.5 mL: Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 mL solution.
Danish: Hver ml af opløsning til injektion/infusion indeholder 60 millioner internationale enheder [mio. IE] (600 mikrogram) filgrastim Ratiograstim 30 mio. IE/0,5 ml: En fyldt injektionssprøjte indeholder 30 millioner internationale enheder [mio. IE] (300 mikrogram) filgrastim i 0,5 ml.
English: Acute respiratory distress syndromea
Danish: Acute respiratory distress syndromea Respirations smertera,e Epistaksi svigta Lungeødem a
English: ● Periodic Safety Update Reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Diarrhoeaa, e Vomitinga,e Nauseaa
Danish: Knogler, led, muskler og bindevæv
English: • injection site reaction
Danish: • Smerter på indsprøjtningsstedet
English: Splenomegaly and Splenic rupture
Danish: Splenomegali og miltruptur
English: Psychiatic diorders
Danish: Psykiske forstyrrelser
English: Posology
Danish: Eddikesyre
English: How do I inject Ratiograstim myself?
Danish: Sådan injicerer De Ratiograstim
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Danish: Opbevares i køleskab (2 °C-8 °C) Opbevaringsforhold efter fortynding af lægemidlet, se pkt.
English: Because of the potential of receiving higher doses of chemotherapy (e.g., full doses on the prescribed schedule) the patient may be at greater risk of thrombocytopenia and anaemia.
Danish: Patienterne kan have større risiko for at udvikle trombocytopeni og anæmi på grund af muligheden for at få højere kemoterapidoser (f. eks. de højeste doser i det foreskrevne doseringsskema).
English: Haemoptysi s
Danish: Svimmelhe d
English: If you use more Ratiograstim than you should
Danish: Hvis De har brugt for meget Ratiograstim
English: Paina
Danish: Hovedpinea
English: Osteoporosi s
Danish: Osteoporose Nedsat knogletæthe d
English: Urine abnormality
Danish: Urinanorma litet
English: Infestations
Danish: Mobilisering
English: The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and white blood cell count).
Danish: Symptomerne omfattede feber, mavesmerter, utilpashed, rygsmerter og øgede inflammationsmarkører
English: Hold the syringe and gently take the cover from the needle without twisting.
Danish: Hold i sprøjten og træk forsigtigt beskyttelseshætten af kanylen uden at vride den. Hiv den ligeud som vist på figur 1 og 2.
English: UAB "Sicor Biotech" filiāle Latvijā
Danish: България Тева Фармасютикълс България ЕООД
English: Dizziness Hypoaesthe sia
Danish: Hypoæstesi Paræstesi
English: Lung infiltrationa
Danish: Lungeinfiltr ationa
English: Anaphylacti c reaction
Danish: Forstyrrelse r i væskebalan ce
English: - in patients with advanced HIV infection which will help reduce the risk of infections.
Danish: Hos patienter med et nedsat antal forstadier kan effekten være nedsat.
English: Belgium on 14/11/2006.
Danish: Belgien den 14/11/2006.
English: Page 2/2©EMEA 2006
Danish: Side 2/2©EMEA 2006
English: This summary was last updated in September 2006.
Danish: Dette sammendrag blev sidst ajourført i 09-2006.
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Danish: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the
English: This document cannot replace a face-to-face discussion with your veterinarian.
Danish: Dette dokument må ikke erstatte en drøftelse ansigt til ansigt med din dyrlæge.
English: In most cases, these effects are mild and stop without any treatment.
Danish: I de fleste tilfælde er disse bivirkninger milde og ophører uden nogen behandling.
English: This is related to the mode of action of the product.
Danish: Dette er forbundet med produktets virkemåde.
English: It is used as part of a programme that also includes controlling the dog's intake of food.
Danish: Det anvendes som en del af et program, der også omfatter kontrol af hundens fødeindtagelse.
English: A reduced appetite may also occur during treatment.
Danish: Der kan også opstå nedsat appetit under behandlingen.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om baggrunden for CVMP's anbefalinger, kan du læse den videnskabelige diskussion (også en del af EPAR).
English: This veterinary medicine has been developed especially for dogs and is not for use in humans.
Danish: Dette veterinærlægemiddel er udviklet specielt til hunde og er ikke beregnet til brug i mennesker.
English: It is available in three pack sizes; 55 ml or 120 ml bottles for dogs weighing up to 36 kg and a 210 ml bottle for dogs weighing up to 48 kg.
Danish: Den fås i tre pakningsstørrelser: flasker med 55 ml eller 120 ml til hunde på op til 36 kg og en flaske med 210 ml til hunde på over 48 kg.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Yarvitan to Janssen Animal Health B.V.B.A.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Yarvitan til Janssen Animal Health B.V.B.A.
English: The weight lowering effect was relatively moderate (in the range of 6-7 % of the weight before treatment).
Danish: Den vægtmindskende effekt var relativt moderat (i området på 6-7 % af hundens vægt før påbegyndelse af behandlingen).
English: Two large field trials were conducted, one in Europe and one in the USA, in healthy dogs which had a bodyweight 20% higher than recommended.
Danish: Der blev foretaget to store feltundersøgelser, en i Europa og en i USA, af raske hunde med en kropsvægt på 20 % over den anbefalede vægt.
English: Information on the prescription status of this product may be found on the label/outer package.
Danish: Oplysninger om udleveringsbestemmelser for dette produkt findes på æskens etiket/ydre emballage.
English: The treatment is an initial measure in an obesity management programme; it has to be combined with changes in diet, which must be continued after treatment is finished.
Danish: Behandlingen udgør et første tiltag i et fedmestyringsprogram; den skal kombineres med ændringer i kosten, som skal fortsætte efter behandlingsafslutningen.
English: Other information about Yarvitan:
Danish: Øvrige oplysninger om Yarvitan:
English: The dogs also received other medicines during the study as required, such as vaccines, worming tablets, anti-flea or anti-tick treatments, antibiotics and anti-inflammatory medicines.
Danish: Hundene fik også anden medicin i løbet af undersøgelsen, såsom vacciner, ormetabletter, midler mod lopper eller skovflåt, antibiotika og antiinflammatoriske lægemidler.
English: If accidental eye contact occurs, flush immediately with lots of water.
Danish: Ved utilsigtet kontakt med øjnene skylles straks med rigeligt vand.
English: The benefit-risk balance may be found in module 6 of this EPAR.
Danish: Risk/benefit-forholdet fremgår af afsnit 6 af denne EPAR.
English: If a person accidentally takes the medicine, seek medical advice immediately and show the package leaflet or the label to a doctor.
Danish: Hvis en person utilsigtet kommer til at tage medicinen, skal der straks søges læge, og indlægssedlen eller etiketten skal medbringes og vises til lægen.
English: Yarvitan has been studied in dogs in both laboratory and field trials.
Danish: Yarvitan blev undersøgt i hunde i både laboratorie- og feltundersøgelser.
English: The dog then receives the medicine for a further 3 weeks, at the same time as the adjusted diet.
Danish: Hunden får derefter medicinen igen i yderligere 3 uger kombineret med den justerede kost.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Yarvitan exceed its risks for the management of overweight and obesity in dogs and recommended that Yarvitan be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) har konkluderet, at Yarvitans gavnlige virkninger er større end de mulige risici ved behandling af overvægt og fedme hos hunde, og anbefalede udstedelse af markedsføringstilladelse for Yarvitan.
English: The active substance in Yarvitan, mitratapide, works in the gut by blocking a protein (the microsomal triglyceride transfer protein).
Danish: Det aktive stof i Yarvitan, mitratapid, virker i tarmen ved at blokere et protein (mikrosomalt triglycerid-transportprotein).
English: The medicine is administered to the dog for 3 weeks, followed by a 2-week medicine-free interval, when the veterinarian will adjust the dog's feeding according to its energy requirements.
Danish: Medicinen indgives til hunden i 3 uger efterfulgt af et medicinfrit 2ugersinterval, hvor dyrlægen justerer hundens fødemængde, så den svarer til hundens energibehov.
English: About three-quarters received Yarvitan while the remainder received the medicine with the active substance removed (control group).
Danish: Cirka tre fjerdedele af hundene fik Yarvitan, mens resten fik medicinen i en formulering, hvor det aktive stof var fjernet (kontrolgruppen).
English: The dose to use is calculated according to the weight of the dog and the Yarvitan solution is given with the animal's food.
Danish: Dosen beregnes ud fra hundens vægt, og Yarvitan-opløsningen indgives sammen med dyrets føde.
English: Yarvitan at the recommended dose and using the 3-2-3 week treatment schedule reduced body weight in obese dogs when compared to the control group.
Danish: Ved den anbefalede dosis og ved brug af et 3-2-3-ugebehandlingsskema reducerede Yarvitan kropsvægten hos fede hunde sammenlignet med kontrolgruppen.
English: Yarvitan contains the active substance mitratapide which helps to reduce weight in dogs.
Danish: Yarvitan indeholder det aktive stof mitratapid, som er med til at fremkalde vægttab hos hunde.
English: Why has Yarvitan been approved?
Danish: Hvorfor blev Yarvitan godkendt?
English: What is the risk associated with Yarvitan?
Danish: Hvilken risiko er der forbundet med Yarvitan?
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) YARVITAN EPAR summary for the public
Danish: EMEA/V/C/0113 EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) YARVITAN EPAR - sammendrag for offentligheden
English: Yarvitan is used in adult dogs that are overweight or obese, to help them lose weight.
Danish: Yarvitan anvendes til fuldvoksne hunde, som er overvægtige eller fede, for at hjælpe dem til et vægttab.
English: What is Yarvitan?
Danish: Hvad er Yarvitan?
English: Vomiting, diarrhoea or softened faeces may occur during treatment.
Danish: Under behandlingen kan der forekomme opkastning, diaré og blød afføring.
English: For a full list of all side-effects reported with Yarvitan, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Yarvitan fremgår af indlægssedlen.
English: Yarvitan is an oral solution, colourless to slightly yellow in colour.
Danish: Yarvitan er en oral opløsning, der er farveløs eller let gullig.
English: Yarvitan also has a slight appetite decreasing effect due to its mode of action.
Danish: På grund af dets virkemåde har Yarvitan også en let appetitmindskende effekt.
English: How has Yarvitan been studied?
Danish: Hvordan blev Yarvitan undersøgt?
English: What is Yarvitan used for?
Danish: Hvad anvendes Yarvitan til?
English: This protein is normally involved in the absorption of fats from the diet. By blocking the protein Yarvitan decreases the absorption of fats from the gut.
Danish: Ved at blokere dette protein mindsker Yarvitan absorptionen af fedtsyrer fra tarmen.
English: What benefit has Yarvitan shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Yarvitan?
English: 1 bottle + 10 ml dosing syringe
Danish: 1 flaske + 10 ml doseringssprøjte
English: Invented name Strength Pharmaceutical form Route of administration Packaging Content
Danish: EU-nummer Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage
English: Bottle (HDPE) 225 ml
Danish: Oral anvendelse Flaske (HDPE) 225 ml
English: EU number
Danish: Indhold
English: 700 mg Film-coated tablets
Danish: 700 mg Filmovertrukne tabletter Oral anvendelse Flaske (HDPE)
English: Pharmaceutical Form Route of Administration Packaging Package size l t o r
Danish: Paknings-størrelse r l
English: (Invented) name Strength
Danish: Særnavn Navn
English: --1 Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ≥ 5.3 log10 FAID50*/ml Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) ≥ 5.3 log10 FAID50*/ml * vCP content checked by global FAID50 (fluorescent assay infectious dose 50%) and qPCR ratio between vCP.
Danish: --1 Influenza A/ eq/Ohio/03 [H3N8] rekombinant canarypox virus (vCP2242) ≥ 5,3 log10 FAID50*/ml Influenza A/eq/Richmond/1/07 [H3N8] rekombinant canarypox virus -vCP3011 ≥ 5,3 log10 FAID50*/ml * vCP indhold kontrolleret ved global FAID50(fluorescent assay" infektiøs dosis 50 %) og qPCR rate mellem vCP.
English: Packaging Content Package Size
Danish: Indgivelsesvej Emballage Indhold Pakningsstørrelse
English: 10 vials Zero days
Danish: Zero dage
English: Horses Intramuscular use Vial (glass) 1 ml
Danish: 1 ml hætteglas
English: Target Species
Danish: Særnavn Styrke
English: Patients can inject themselves if they have been trained appropriately.
Danish: Patienterne kan injicere sig selv, hvis de er blevet behørigt instrueret heri.
English: Neutropenia lasted 1 day on average with both medicines.
Danish: Neutropenien varede i gennemsnit én dag ved begge lægemidler.
English: Filgrastim has been available in other medicines in the European Union (EU) for a number of years.
Danish: Filgrastim har været markedsført i andre lægemidler i Den Europæiske Union (EU) i en årrække.
English: Further information on Fulphila can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/fulphila.
Danish: Yderligere information om Fulphila findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/fulphila.
English: Other information about Fulphila
Danish: Andre oplysninger om Fulphila
English: This means that Fulphila is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Fulphila i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: What measures are being taken to ensure the safe and effective use of Fulphila?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Fulphila?
English: The most common side effect with Fulphila (which may affect more than 1 in 10 people) is pain in the bones.
Danish: Den hyppigste bivirkning ved Fulphila (som optræder hos mere end 1 ud af 10 patienter) er knoglesmerter.
English: Side effects reported with Fulphila are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Fulphila vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: As for all medicines, data on the use of Fulphila are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Fulphila løbende overvåget.
English: Fulphila is a ‘biosimilar medicine'.
Danish: Fulphila er et "biosimilært lægemiddel".
English: An overview of Fulphila and why it is authorised in the EU
Danish: En oversigt over Fulphila, og hvorfor det er godkendt i EU
English: For more information about using Fulphila, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Fulphila, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: This slows down the removal of filgrastim from the body, allowing the medicine to be given less often.
Danish: Derved fjernes filgrastim langsommere fra kroppen, så lægemidlet ikke skal indgives så ofte.
English: Fulphila can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Danish: Fulphila udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af kræft eller blodforstyrrelser.
English: The reference medicine for Fulphila is Neulasta.
Danish: Referencelægemidlet for Fulphila er Neulasta.
English: It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever).
Danish: Det gives specifikt for at reducere varigheden af neutropeni og forebygge såkaldt febril neutropeni, dvs. neutropeni ledsaget af feber.
English: Fulphila is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Danish: Fulphila gives som en enkeltdosis på 6 mg, der injiceres under huden mindst 24 timer efter afslutningen af hver behandlingsserie med kemoterapi (behandling med kræftlægemidler).
English: Pain in muscles is also common.
Danish: Muskelsmerter er også en almindelig bivirkning.
English: Why is Fulphila authorised in the EU?
Danish: Hvorfor blev Fulphila godkendt i EU?
English: The safety of Fulphila has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta.
Danish: Sikkerheden ved Fulphila er blevet vurderet, og på grundlag af alle de gennemførte studier anses bivirkningerne ved lægemidlet for at være sammenlignelige med bivirkningerne af referencelægemidlet Neulasta.
English: Because Fulphila is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Fulphila.
Danish: Da Fulphila er et biosimilært lægemiddel, behøver de studier af pegfilgrastims virkning og sikkerhed, der er udført for Neulasta, ikke alle at blive gentaget for Fulphila.
English: What is Fulphila and what is it used for?
Danish: Hvad er Fulphila, og hvad anvendes det til?
English: The active substance in Fulphila, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Danish: Det aktive stof i Fulphila, pegfilgrastim, er en form for filgrastim, der minder meget om det menneskelige protein granulocyt-kolonistimulerende faktor (G-CSF).
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Fulphila has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Fulphila har en struktur, renhed og biologisk aktivitet, der svarer til Neulastas, og at det fordeles i kroppen på samme måde.
English: Therefore, the Agency's view was that, as for Neulasta, the benefit of Fulphila outweighs the identified risk and it can be authorised for use in the EU.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Fulphila opvejer de identificerede risici som for Neulasta, og at det kan godkendes til anvendelse i EU.
English: Fulphila is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Danish: Fulphila er ikke beregnet til brug hos patienter med blodkræfttypen kronisk myeloid leukæmi eller myelodysplastisk syndrom (tilstand, hvor der produceres et stort antal blodlegemer, som kan udvikle sig til leukæmi).
English: What are the risks associated with Fulphila?
Danish: Hvilke risici er der forbundet med Fulphila?
English: In addition, a study involving 194 patients who had chemotherapy before or after surgery for breast cancer showed that Fulphila was as effective as Neulasta in reducing the duration of neutropenia.
Danish: Desuden fremgik det af to studier med 194 patienter, der var i behandling med kemoterapi før eller efter brystkræftoperation, at Fulphila var lige så effektivt som Neulasta til at reducere varigheden af neutropeni.
English: All these data were considered sufficient to conclude that Fulphila will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses.
Danish: Disse oplysninger blev anset for tilstrækkelige til at konkludere, at Fulphila vil have de samme egenskaber som Neulasta, hvad angår sikkerhed og virkning ved de godkendte anvendelser.