natgillin/translations-raw huggingface dataset:
Behandling med Binocrit kan være forbundet med en øget risiko for blodprop efter operationen (postoperativ blodpropdannelse/ vaskulære sygdomme), hvis koncentrationen af rød blodpigment er for høj.
Treatment with Binocrit may be associated with an increased risk of blood clotting after the surgery (postoperative thrombotic/ vascular disorders) if your levels of the red blood pigment are too high.
OPBEVARING
HOW TO STORE BINOCRIT
- Du må gerne tage Binocrit ud af køleskabet og opbevare det ved rumtemperatur (op til 25°C),
- You may take Binocrit out of the refrigerator and keep it at room temperature (up to 25°C) for
Binocrit indeholder
What Binocrit contains
- Det aktive stof er binocrit.
- The active substance is epoetin alfa.
En fyldt
Binocrit 1000 IU/ 0.5 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 0.5 ml solution for injection contains 1000 international units (IU) corresponding to 8.4 micrograms epoetin alfa Binocrit 2000 IU/ 1 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 1 ml solution for injection contains 2000 international units (IU) corresponding to 16.8 micrograms epoetin alfa Binocrit 3000 IU/ 0.3 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 0.3 ml solution for injection contains 3000 international units (IU) corresponding to 25.2 micrograms epoetin alfa Binocrit 4000 IU/ 0.4 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 0.4 ml solution for injection contains 4000 international units (IU) corresponding to 33.6 micrograms epoetin alfa Binocrit 5000 IU/ 0.5 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 0.5 ml solution for injection contains 5000 international units (IU) corresponding to 42.0 micrograms epoetin alfa Binocrit 6000 IU/ 0.6 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 0.6 ml solution for injection contains 6000 international units (IU) corresponding to 50.4 micrograms epoetin alfa Binocrit 7000 IU/ 0.7 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 0.7 ml solution for injection contains 7000 international units (IU) corresponding to 58.8 micrograms epoetin alfa Binocrit 8000 IU/ 0.8 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 0.8 ml solution for injection contains 8000 international units (IU) corresponding to 67.2 micrograms epoetin alfa Binocrit 9000 IU/ 0.9 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 0.9 ml solution for injection contains 9000 international units (IU) corresponding to 75.6 micrograms epoetin alfa Binocrit 10 000 IU/ 1 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 1 ml solution for injection contains 10 000 international units (IU) corresponding to 84.0 micrograms epoetin alfa
Udseende og pakningsstørrelser
195 What Binocrit looks like and contents of the pack
Sprøjterne indeholder 0, 5 ml (1000 IE) opløsning.
Binocrit 1000 IU/ 0.5 ml solution for injection in a pre-filled syringe The syringes contain 0.5 ml (1000 IU) of solution.
Sprøjterne indeholder 1 ml (2000 IE) opløsning.
Binocrit 2000 IU/ 1 ml solution for injection in a pre-filled syringe The syringes contain 1 ml (2000 IU) of solution.
Sprøjterne indeholder 0, 3 ml (3000 IE) opløsning.
Binocrit 3000 IU/ 0.3 ml solution for injection in a pre-filled syringe The syringes contain 0.3 ml (3000 IU) of solution.
Sprøjterne indeholder 0, 4 ml (4000 IE) opløsning.
Binocrit 4000 IU/ 0.4 ml solution for injection in a pre-filled syringe The syringes contain 0.4 ml (4000 IU) of solution.
Sprøjterne indeholder 0, 5 ml (5000 IE) opløsning.
Binocrit 5000 IU/ 0.5 ml solution for injection in a pre-filled syringe The syringes contain 0.5 ml (5000 IU) of solution.
Sprøjterne indeholder 0, 6 ml (6000 IE) opløsning.
Binocrit 6000 IU/ 0.6 ml solution for injection in a pre-filled syringe The syringes contain 0.6 ml (6000 IU) of solution.
Sprøjterne indeholder 0, 7 ml (7000 IE) opløsning.
Binocrit 7000 IU/ 0.7 ml solution for injection in a pre-filled syringe The syringes contain 0.7 ml (7000 IU) of solution.
Sprøjterne indeholder 0, 8 ml (8000 IE) opløsning.
Binocrit 8000 IU/ 0.8 ml solution for injection in a pre-filled syringe The syringes contain 0.8 ml (8000 IU) of solution.
Sprøjterne indeholder 0, 9 ml (9000 IE) opløsning.
Binocrit 9000 IU/ 0.9 ml solution for injection in a pre-filled syringe The syringes contain 0.9 ml (9000 IU) of solution.
Sprøjterne indeholder 1 ml (10. 000 IE) opløsning.
Binocrit 10 000 IU/ 1 ml solution for injection in a pre-filled syringe The syringes contain 1 ml (10 000 IU) of solution.
10 A- 6250 Kundl Østrig.
10 A-6250 Kundl Austria
Hexal AG Industriestraße 25 D- 83607 Holzkirchen Tyskland.
Hexal AG Industriestraße 25 D-83607 Holzkirchen Germany
206 Hvis du vil have yderligere oplysninger om Binocrit, skal du henvende dig til den lokale repræsentant:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
207 France Sandoz SAS Direction Scientifique et Marketing Biotech 49, avenue Georges Pompidou F- 92593 Levallois- Perret Cedex Tél: +33 1 49 64 48 00
France Sandoz SAS Direction Scientifique et Marketing Biotech 49, avenue Georges Pompidou F-92593 Levallois-Perret Cedex
Livezeni, Nr 7A Târgu Mureş, 540472 - HO Tel: +40 265 208 120
Livezeni, Nr 7A Târgu Mureş, 540472 - RO Tel: +40 265 208 120
Denne indlægsseddel blev senest godkendt den {MM/ ÅÅÅÅ}.
This leaflet was last approved in {MM/ YYYY}.
Biograstim er et ‘ biosimilært ’ lægemiddel.
Biograstim is a ‘ biosimilar’ medicine.
Det betyder, at Biograstim svarer til et biologisk lægemiddel, som allerede er godkendt i Den Europæiske Union (EU), og som indeholder det samme aktive stof (også kendt som "referencelægemidlet").
This means that Biograstim is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘ reference medicine’).
Biograstim anvendes til at stimulere dannelsen af hvide blodlegemer i følgende tilfælde: • til at reducere varigheden af neutropeni (lavt antal af neutrofiler, en type hvide blodlegemer) og forekomsten af febril neutropeni (neutropeni med feber) hos patienter, der får kemoterapi (cancerbehandling), som er cytotoksisk (celledræbende) • til at reducere varigheden af neutropeni hos patienter, der er under behandling, for at tilintetgøre knoglemarvsceller inden en knoglemarvstransplantation (som for eksempel hos visse patienter med leukæmi), hvis der er risiko for, at de får langvarig svær neutropeni • til at øge neutrofiltallet og reducere risikoen for infektion (betændelse) hos patienter med neutropeni, der gentagne gange tidligere har haft alvorlige infektioner • til at behandle vedvarende neutropeni hos patienter med fremskreden hiv- infektion for at reducere risikoen for bakterielle infektioner, når andre behandlingsmuligheder ikke er hensigtsmæssige.
Biograstim is used to stimulate the production of white blood cells in the following situations: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing); • to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at a risk of long-term, severe neutropenia; • to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections; • to treat persistent neutropenia in patients with advanced human immunodeficiency virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Hvordan lægemidlet gives, doseres og hvor længe behandlingen skal vare, afhænger af, hvorfor lægemidlet anvendes, hvor meget patienten vejer, og hvordan patienten reagerer på behandlingen.
How it is given, the dose and the duration of treatment depend on why it is being used, the patient’ s body weight and the response to treatment.
Det aktive stof i Biograstim, filgrastim, svarer i høj grad til et humant protein kaldet granulocyt kolonistimulerende faktor (G- CSF).
The active substance in Biograstim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Det produceres af en bakterie, der har modtaget et gen (DNA), som gør den i stand til at producere filgrastim.
Filgrastim is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce filgrastim.
Det kunstigt fremstillede middel virker på samme måde som det naturligt fremstillede G- CSF ved at tilskynde knoglemarven til at producere flere hvide blodlegemer.
The replacement acts in same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
For at undersøge sikkerheden af Biograstim blev der gennemført to undersøgelser af patienter med lungecancer og non- Hodgkin' s lymfom (en form for lymfekræft).
To study the safety of Biograstim, two further studies were carried out in patients with lung cancer and with non-Hodgkin’ s lymphoma.
I løbet af deres første kemoterapicyklus på 21 dage havde patienter behandlet med Biograstim eller Neupogen svær neutropeni i gennemsnitligt 1, 1 dag sammenlignet med 3, 8 dage hos dem, der fik placebo.
During the first 21-day chemotherapy cycle, patients treated with either Biograstim or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo.
Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at Biograstim i overensstemmelse med EU’ s krav har en profil med hensyn til kvalitet, sikkerhed og virkning, som svarer til Neupogen.
The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Biograstim has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Det var derfor CHMP' s opfattelse, at fordelene opvejer de identificerede risici som for Neupogen.
Therefore, the CHMP’ s view was that, as for Neupogen, the benefit outweighs the identified risk.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Biograstim til CT Arzneimittel GmbH den 15. september 2008.
The European Commission granted a marketing authorisation valid throughout the EU for Biograstim to CT Arzneimittel GmbH on 15 September 2008.
30 MIU (300 µg /
Strength 30 MIU (300 µg/ 0.5 ml)
Injektions - og infusionsvæske
Pharmaceutical Form Solution for injection or infusion
Subkutan eller intravenøs anvendelse
Route of Administration Subcutaneous or intravenous use
Fyldt injektionssprøjte (glas)
Packaging pre-filled syringe (glass)
1 fyldt injektionssprøjte
Package size 1 pre-filled syringe
30 MIU (300 µg /
30 MIU (300 µg/ 0.5 ml)
Injektions - og infusionsvæske
Solution for injection or infusion
Fyldt 0. 5 ml injektionssprøjte (glas)
pre-filled syringe (glass)
2 x 5 fyldte injektionssprøjter
2 x 5 pre-filled syringes
48 MIU (480 µg /
48 MIU (480 µg/ 0.8 ml)
Fyldt 0. 8 ml injektionssprøjte (glas)
pre-filled syringe (glass)
1 pre- filled syringe
1 pre-filled syringe
IE/ 0, 5 ml injektions - og infusionsvæske, opløsning
Biograstim 30 MIU/ 0.5 ml solution for injection or infusion
IE] (600 µg) af filgrastim.
Each ml of solution for injection or infusion contains 60 million international units [MIU] (600 µg) of filgrastim.
IE (300 µg) filgrastim i 0, 5 ml injektions - og infusionsvæske, opløsning.
Each pre-filled syringe contains 30 MIU (300 µg) of filgrastim in 0.5 ml solution for injection or infusion.
Filgrastim (rekombinant methionyl human granulocytkolonistimulerende faktor) fremstilles i Escherichia coli K802 ved hjælp af rekombinant DNA- teknologi.
Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor) is produced in Escherichia coli K802 by recombinant DNA technology.
1 ml opløsning indeholder 50 mg sorbitol.
Each ml of solution contains 50 mg of sorbitol.
Injektions - og infusionsvæske, opløsning
Solution for injection or infusion
Hos patienter, såvel børn som voksne, med svær kongenit cyklisk eller idiopatisk neutropeni med et absolut neutrofiltal (ANC) på 0, 5 x 109/ l og svære eller recidiverende infektioner i anamnesen er langtidsbehandling med Biograstim indiceret for at øge neutrofiltallet og reducere forekomst og varighed af hændelser relateret til infektionen.
In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/ l, and a history of severe or recurrent infections, long term administration of Biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Biograstim er indiceret til behandling af vedvarende neutropeni (ANC ≤ 1, 0 x 109/ l) hos patienter med fremskreden hiv- infektion for at reducere risikoen for bakterielle infektions, når andre behandlingsmuligheder ved neutropeni ikke er hensigtsmæssige..
Biograstim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/ l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Filgrastimterapi må kun gives i samarbejde med et onkologisk center, som har erfaring i at behandle med granulocytkolonistimulerende faktorer (G- CSF) og hæmatologi, og som har det nødvendige diagnostiske udstyr.
Filgrastim 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.
Mobiliserings - og afereseprocedurer bør udføres i samarbejde med et onkologisk
The mobilisation and apheresis procedures should be performed in
2 og hæmatologisk center med tilstrækkelig erfaring inden for dette område og kapacitet til at udføre korrekt monitorering af hæmatopoietiske stamceller.
2 collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
IE (5 μg) / kg/ døgn.
The recommended dose of filgrastim is 0.5 MIU (5 μ g)/ kg/ day.
6. 6).
Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in glucose 50 mg/ ml (5%) solution for infusion given over 30 minutes (see section 6.6 for instructions on dilution).
IE (230 μg) / m2/ døgn (4, 0 til 8, 4 μg/ kg/ døgn)
In randomised clinical trials, a subcutaneous dose of 23 MIU (230 μ g)/ m2/ day (4.0 to 8.4 μ g/ kg/ day) was used.
Hos patienter, der får kemoterapi, vil der typisk opstå en forbigående stigning i neutrofiltallet 1- 2 dage efter indledning af behandling med filgrastim.
In patients receiving cytotoxic chemotherapy, a transient increase in neutrophil counts is typically seen 1 to 2 days after initiation of filgrastim therapy.
Det frarådes at seponere filgrastim præmaturt, d. v. s. før tidspunktet for det forventede nadir er indtruffet.
Premature discontinuation of filgrastim therapy prior to the time of the expected neutrophil nadir is not recommended.
IE (10 μg) / kg/ døgn, der gives som kontinuerlig subkutan infusion over 24 timer.
The recommended starting dose of filgrastim is 1.0 MIU (10 μ g)/ kg/ day given as a 30 minute or 24 hour intravenous infusion or 1.0 MIU (10 μ g)/ kg/ day given by continuous 24 hour subcutaneous infusion.
6. 6).
Filgrastim should be diluted in 20 ml of glucose 50 mg/ ml (5%) solution for infusion (see section 6.6 for instructions on dilution).
Neutrofiltal > 1, 0 x 109/ l i 3 dage i træk Hvis det absolutte neutrofiltal holder sig > 1, 0 x 109/ l i over 3 dage i træk
Neutrophil count > 1.0 x 109/ l for 3 consecutive days Then, if ANC remains > 1.0 x 109/ l for 3 more consecutive days
IE (5 µg) / kg/ døgn Seponer filgrastim
Filgrastim dose adjustment Reduce to 0.5 MIU (5 µg)/ kg/ day Discontinue filgrastim
Hvis det absolutte neutrofiltal falder til < 1, 0 x 109/ l i løbet af behandlingen, bør doseringen af filgrastim øges igen ved at følge ovennævnte procedure i omvendt rækkefølge.
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
Til mobilisering af perifere blodstamceller( PBPC) hos patienter i myelosuppressiv eller myeloablativ terapi efterfulgt af autolog perifer blodstamcelletransfusion
For the mobilisation of PBPC in patients undergoing myelosuppressive or myeloablative therapy followed by autologous peripheral blood progenitor cell transplantation
IE (10 μg) / kg/ døgn, der gives over 24 timer som subkutan kontinuerlig infusion eller som en enkelt daglig subkutan injektion 5- 7 dage i træk.
The recommended dose of filgrastim for PBPC mobilisation when used alone is 1.0 MIU (10 μ g)/ kg/ day as a 24 hour subcutaneous continuous infusion or a single daily subcutaneous injection for 5 to 7 consecutive days.
Tidsplan for
For infusions, filgrastim should be diluted in 20 ml of glucose 50 mg/ ml (5%) solution for infusion (see section 6.6 for instructions on dilution).
3 leukaferese:
Timing of leukapheresis:
Ofte vil 1- 2 leukafereser på dag 5 og 6 være tilstrækkeligt.
1 or
IE (5 μg) / kg/ døgn, der gives dagligt som subkutan injektion fra den første dag efter afslutning af kemoterapien og indtil det forventede neutrofilnadir passeres, og neutrofiltallet atter ligger inden for normalområdet.
The recommended dose of filgrastim for PBPC mobilisation after myelosuppressive chemotherapy is 0.5 MIU (5 μ g)/ kg/ day given daily by subcutaneous injection from the first day after completion of chemotherapy until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Der bør gives leukaferese, mens det absolutte neutrofiltal stiger fra < 0, 5 x 109/ l til > 5, 0 x 109/ l.
Leukapheresis should be performed during the period when the ANC rises from < 0.5 x 109/l to > 5.0 x 109/l.
IE (10 μg) / kg/ døgn i 4- 5 dage i træk.
For PBPC mobilisation in normal donors, filgrastim should be administered at 1.0 MIU (10 μ g)/ kg/ day subcutaneously for 4 to 5 consecutive days.
Leukaferese skal indledes på dag 5 og fortsættes efter behov indtil dag 6, så der kan høstes 4 x 106 CD34+ celler/ kg legemsvægt hos recipienten.
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.
IE (12 μg) / kg/ døgn, der gives subkutant som enkeltdosis eller fordelt på flere doser.
Congenital neutropenia The recommended starting dose is 1.2 MIU (12 μ g)/ kg/ day subcutaneously as a single dose or in divided doses.
IE (5 μg) / kg/ døgn, der gives subkutant som enkeltdosis eller fordelt på flere doser.
Idiopathic or cyclic neutropenia The recommended starting dose is 0.5 MIU (5 μ g)/ kg/ day subcutaneously as a single dose or in divided doses.
Dosisjustering Filgrastim bør administreres dagligt som subkutan injektion, indtil neutrofiltallet er over 1, 5 x 109/ l og kan fastholdes på dette niveau.
Dose adjustment 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.
Efter 1- 2 ugers behandling kan initialdosis fordobles eller halveres afhængigt af patientens respons.
After one to two weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response.
Efterfølgende kan dosis justeres individuelt hver eller hver anden uge for at opretholde et gennemsnitligt neutrofiltal mellem 1, 5 x 109/ l og 10 x 109/ l.
Subsequently the dose may be individually adjusted every 1 to 2 weeks to maintain the average neutrophil count between 1.5 x 109/ l and 10 x 109/ l.
I kliniske forsøg opnåede 97% af respondenterne fuldstændigt respons ved doser på 2, 4 mio.
In clinical trials, 97% of patients who responded had a complete response at doses of 2.4 MIU (24 μ g)/ kg/ day.
IE (24 μg) / kg/ døgn til patienter med SCN.
The long-term safety of filgrastim administration above 2.4 MIU (24 μ g)/ kg/ day in patients with SCN has not been established.
Patienter med hiv- infektion
In patients with HIV infection
IE (4 μg) / kg/ døgn, indtil neutrofiltallet atter er normalt og kan fastholdes på dette niveau (ANC > 2, 0 x109/ l).
For reversal of neutropenia The recommended starting dose of filgrastim is 0.1 MIU (1 μ g)/ kg/ day given daily by subcutaneous injection with titration up to a maximum of 0.4 MIU (4 μ g)/ kg/ day until a normal neutrophil count is reached and can be maintained (ANC > 2.0 x109/ l).
I kliniske forsøg responderede > 90% af patienterne på disse doser og opnåede reversering af neutropeni på 2 dage i gennemsnit.
In clinical studies, > 90% of patients responded at these doses, achieving reversal of neutropenia in a median of 2 days.
IE (10 μg) / kg/ døgn for at reversere neutropeni.
In a small number of patients (< 10%), doses up to 1.0 MIU (10 μ g)/ kg/ day were required to achieve reversal of neutropenia.
Opretholdelse af normalt neutrofiltal Efter reversering af neutropeni fastlægges den mindste effektive dosis, der kan opretholde et normalt neutrofiltal.
For maintaining normal neutrophil counts When reversal of neutropenia has been achieved, the minimal effective dose to maintain a normal neutrophil count should be established.
IE (300 μg) / døgn som subkutan injektion.
Initial dose adjustment to alternate day dosing with 30 MIU (300 μ g)/ day by subcutaneous injection is recommended.
Der kan opstå behov for yderligere dosisjustering afhængigt af patientens ANC for at opretholde et neutrofiltal på > 2. 0 x 109/ l.
Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at > 2.0 x 109/ l.
I kliniske forsøg var det nødvendigt at give 30 mio.
In clinical studies, dosing with 30 MIU (300 μ g)/ day on 1 to 7 days per week was required to maintain the ANC
IE (300 μg) / døgn i 1- 7 dage om ugen for at opretholde ANC > 2, 0 x 109/ l, med en gennemsnitlig doseringshyppighed på 3 dage om ugen.
4 > 2.0 x 109/ l, with the median dose frequency being 3 days per week.
For at opretholde et ANC > 2, 0 x 109/ l kan langtidsbehandling være nødvendig.
Long-term administration may be required to maintain the ANC > 2.0 x 109/ l.
4 Særlige befolkningsgrupper
Special populations
Ældre I kliniske forsøg med filgrastim indgik et mindre antal ældre patienter, men der foreligger ingen undersøgelser specielt med denne gruppe, hvorfor der ikke kan gives specifikke dosisanbefalinger.
Elderly patients 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 dosage recommendations cannot be made.
Nedsat nyre - eller leverfunktion Undersøgelser af filgrastim hos patienter med svært nedsat nyre - eller leverfunktion har vist, at stoffet udviser samme farmakokinetiske og farmakodynamiske profil som hos raske mennesker.
Patients with renal or hepatic impairment Studies of filgrastim in patients with severe impairment of renal or hepatic function demonstrate that it exhibits a similar pharmacokinetic and pharmacodynamic profile to that seen in normal individuals.
Børn med SCN og cancer 65% af de patienter, der indgik i SCN- forsøgsprogrammet, var under 18 år.
Paediatric use in the SCN and cancer settings Sixty-five percent of the patients studied in the SCN trial programme were under 18 years of age.
Ondartet cellevækst Granulocytkolonistimulerende faktor kan fremme væksten af myeloide celler in vitro, og lignende virkninger kan også ses på visse ikke- myeloide celler in vitro.
Malignant cell growth Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may also be seen on some non-myeloid cells in vitro.