FrancophonIA/ELRC3.0 huggingface dataset:
English: • serious, potentially life-threatening allergic reaction (see section 2).
Danish: Det kan være tegn på skader på knoglerne i øret.• alvorlig, eventuelt livstruende, allergisk reaktion (se punkt 2).
English: At two years, 87.1 % (p<0.001) and 70.5 %,of patients met this criterion in the 150 mg monthly and 2.5 mg daily arms respectively.
Danish: (p<0,001) og 70,5 % af patienterne dette kriterie i armene for henholdsvis 150 mg én gang om måneden og 2,5 mg daglig.
English: Due to the limited clinical experience, Bonviva is not recommended in patients with severe renal impairment (see section 4.2 and section 4.4).
Danish: På grund af begrænsede erfaringer, kan Bonviva ikke anbefales til patienter med svært nedsat nyrefunktion (se pkt.
English: At two years 93.4 % (p<0.001) of patients receiving Bonviva 150 mg once monthly and 78.4 %, of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline.
Danish: Efter to år havde 93,4 % (p<0,001) af patienterne, som fik henholdsvis Bonviva 150 mg én gang om måneden og 78,4 % af patienterne, som fik ibandronsyre 2,5 mg daglig, stigninger i hofte BMD over eller lig baseline.
English: Hypocalcaemia
Danish: - Hypokalcæmi.
English: NAME OF THE MEDICINAL PRODUCT Bonviva 3 mg solution for injection
Danish: LÆGEMIDLETS NAVN Bonviva 3 mg injektionsvæske, opløsning
English: Gastritis, Dyspepsia, Diarrhoea,
Danish: Mave-tarmkanalen Gastritis, dyspepsi, diarré, mavesmerter, kvalme, forstoppelse
English: (see section 4.5).
Danish: 4.4 og 4.5).
English: Patients must receive supplemental calcium and vitamin D (see section 4.4 and section 4.5),
Danish: Patienten skal have et calcium- og vitamin D-tilskud (se pkt.
English: ibandronic acid 2.5 mg daily (N=318)
Danish: ibandronsyre 2,5 mg daglig (N=318)
English: • not smoking; and not drinking too much alcohol.
Danish: • at undgå rygning og for meget alkohol.
English: (see 3.
Danish: Tabel 3:
English: How to take Bonviva
Danish: Sådan skal du tage Bonviva
English: How to receive Bonviva
Danish: Sådan får du Bonviva
English: The dose of Bonviva is one tablet once a month.
Danish: PLANLÆGNING AF HVORNÅR BONVIVA SKAL INDTAGES Doseringen af Bonviva er én tablet om måneden.
English: Planning when to take Bonviva with peel-off stickers for your personal calendar What Bonviva is and what it is used for What you need to know before you take Bonviva How to take Bonviva
Danish: Planlæg indtagelsen af Bonviva med de aftagelige klistermærker i din personlige kalender 1 Virkning og anvendelse
English: How to take Bonviva).
Danish: (Se punkt 3 ”Sådan skal du tage Bonviva”).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as sodium monohydrate).
Danish: En fyldt injektionssprøjte med 3 ml opløsning, indeholder 3 mg ibandronsyre (som natriummonohydrat).
English: Bonviva injection is not recommended for use in patients who have a serum creatinine above 200 μmol/l (2.3 mg/dl) or who have a creatinine clearance (measured or estimated) below 30 ml/min, because of limited clinical data available from studies including such patients (see section 4.4 and section 5.2).
Danish: behandling med Bonviva ikke anbefales til patienter med serumkreatinin højere end 200 μmol/l (2,3 mg/dl) eller med en kreatininclearance mindre end 30 ml/min (se pkt.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen, apotekspersonalet eller sundhedsspersonalet, hvis der er mere, du vil vide.
English: • bone pain
Danish: • nældefeber
English: What Bonviva looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: PLANNING WHEN TO TAKE BONVIVA
Danish: Når du fortsat får Bonviva
English: Sodium chloride solution (0.9%)
Danish: Natriumchloridopløsning (0.9 %)
English: PROHIBITION OF SALE; SUPPLY AND/OR USE Not applicable.
Danish: FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG Ikke relevant.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: adjuvans) anført under punkt 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Keep the bottle in the outer carton in order to protect from light.
Danish: Hætteglasset opbevares i den ydre karton for at beskytte mod lys.
English: For intramuscular use.
Danish: Intramuskulær anvendelse.
English: 0.21 mg For the full list of excipients, see section 6.1.
Danish: 0,21 mg Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection only a minor injection site reaction is expected.
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: I tilfælde af selvinjektion ved hændeligt uheld forventes kun en mindre lokal reaktion på injektionsstedet.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu/).
English: Strains of inactivated Influenza A virus/swine/
Danish: Stammer af inaktiveret Influenza A virus/svin/
English: On very rare occasions, a slight transient rectal temperature increase might occur after vaccination (“very rare” corresponds to a frequency of adverse reactions less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Meget sjældent ses en forbigående, let stigning i legemstemperatur efter vaccination (”Meget sjælden” svarer til bivirkninger hos færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: DATE OF FIRST AUTHORISATION Date of first authorisation: 14/01/2010 Date of last renewal: 04/12/2014
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 04/12/2014
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu/).
English: Adjuvant: Carbomer 971 P NF
Danish: Adjuvans: Carbomer 971 P NF
English: 1GMNU = Geometric mean of neutralizing units induced in Guinea pigs after twice immunisation with 0.5 ml of this vaccine
Danish: 1GMNU = Geometrisk gennemsnit af neutraliserende enheder induceret i marsvin efter to gange immunisering med 0,5 ml af denne vaccine
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Strains of inactivated Influenza A virus/swine
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Stammer af inaktiveret Influenza A virus/svin/
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 dosis på 2 ml indeholder:
English: WITHDRAWAL PERIOD Withdrawal period: zero days
Danish: TILBAGEHOLDELSESTID Tilbageholdelsestid: 0 dage
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/103/003
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/09/103/003
English: Pharmacotherapeutic group: Immunologicals, Inactivated viral vaccines ATCvet code: QI09AA03
Danish: IMMUNOLOGISKE EGENSKABER Farmakoterapeutisk gruppe: Immunologica, Inaktiverede virale vacciner ATCvet-kode:
English: STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS Each dose of 2 ml contains:
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER 1 dosis på 2 ml indeholder:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box for 20ml, 50 ml, 100 ml, 8 x 500 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske med 20 ml, 50 ml, 100 ml eller 8 x 500 ml
English: 20 ml vials, glass type I 50 ml vials, glass type II 100 ml vials, glass type II
Danish: Glas hætteglas: 20 ml hætteglas, glas type I 50 ml hætteglas, glas type II 100 ml hætteglas, glas type II
English: PHARMACEUTICAL FORM Clear, yellowish orange to pink coloured suspension for injection.
Danish: LÆGEMIDDELFORM Klar, gul/orange til pinkfarvet suspension til injektion
English: PACKAGE SIZE 100 ml (50 doses) 500 ml (250 doses)
Danish: PAKNINGSSTØRRELSE 100 ml (50 doser) 500 ml (250 doser)
English: EXP {month/year} Once opened, use within 10 hours.
Danish: Efter anbrud anvendes inden for 10 timer.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Major incompatibilities
Danish: 6.2 Væsentlige uforligeligheder
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Respiporc FLU3 suspension for injection for pigs
Danish: VETERINÆRLÆGEMIDLETS NAVN Respiporc FLU3 injektionsvæske, suspension, til svin
English: 20 ml (10 doses) 50 ml (25 doses) 100 ml (50 doses) 8 x 500 ml (250 doses)
Danish: 20 ml (10 doser), 50 ml (25 doser), 100 ml (50 doser), 8 x 500 ml (250 doser)
English: 20 ml Polyethylene terephthalate (PET) vials, clear 50 ml PET vials, clear
Danish: PET-hætteglas: 20 ml polyethylenterephthalat (PET)-hætteglas, klare 50 ml PET hætteglas, klare
English: Special warnings for each target species
Danish: 4.4 Særlige advarsler for hver enkelt dyreart, som lægemidlet er beregnet til
English: PACKAGE LEAFLET: Respiporc FLU3 Suspension for injection for pigs
Danish: INDLÆGSSEDDEL: Respiporc FLU3 Injektionsvæske, suspension, til svin
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER
English: 500 ml PET vials, clear
Danish: 500 ml PET hætteglas, klare
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial of 100 ml and 500 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Hætteglas á 100 ml og 500 ml
English: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above.
Danish: 4 måneder hos grise, der blev vaccineret i alderen mellem 56 og 96 dage.
English: 0.21 mg Clear, yellowish orange to pink coloured suspension for injection.
Danish: Klar, gul/orange til pinkfarvet injektionsvæske til suspension.
English: Special precautions for use in animals Not applicable.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr
English: EXPIRY DATE EXP {month/year} Once opened, use within 10 hours.
Danish: Efter anbrud/åbning anvendes inden for 10 timer.
English: Indication for use, specifying the target species Active immunisation of pigs from the age of 56 days onwards including pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Aktiv immunisering af svin fra de er 56 dage gamle samt drægtige søer mod svineinfluenza forårsaget af subtyperne H1N1, H3N2 og H1N2 for at reducere kliniske symptomer og spredning af virus til lungerne efter infektion.
English: Withdrawal period
Danish: 4.11 Tilbageholdelsestid
English: STATEMENT OF ACTIVE SUBSTANCES Each dose of 2 ml contains:
Danish: 1 dosis på 2 ml indeholder:
English: Cardboard box with 8 PET vials of 250 doses (500 ml) with a rubber stopper and flanged cap.
Danish: Æske med 8 PET-hætteglas á 250 doser (500 ml) med gummiprop og ombøjet hætte.
English: Keep the vial in the outer carton in order to protect from light.
Danish: Beskyttes mod lys.
English: Adjuvant:
Danish: Prop:
English: Nature and composition of immediate packaging Glass vial:
Danish: 6.5 Den indre emballages art og indhold
English: Oral use sachet (PET/alu/LLDPE)
Danish: Oral anvendelse Brev (PET/alu/LLDPE) 30 breve
English: 50 mg
Danish: 50 mg Oralt pulver
English: You will need to have your injections at about the same time every day.
Danish: Du skal tage indsprøjtningerne på omtrent samme tidspunkt hver dag.
English: Not known: cannot be estimated from the available data.
Danish: Ikke kendt: kan ikke estimeres ud fra forhåndenværende data
English: AT / BE / BG / CY / CZ / DE / DK / EE / EL / FI / HR / HU / IS / LT / LV / LX/ MT / NL / NO / PT / PL / RO / SE / SI / SK / UK/ ES Accord Healthcare S.L.U.
Danish: AT / BE / BG / CY / CZ / DE / DK / EE / EL / FI / HR / HU / IS / LT / LV / LX/ MT / NL / NO / PT / PL / RO / SE / SI / SK / UK/ ES
English: The syringe may contain more liquid than you need.
Danish: Sprøjten kan indeholde mere væske, end du skal bruge.
English: Tell your doctor immediately during treatment:
Danish: Fortæl straks din læge under behandlingen:
English: Accofil is useful in several different conditions which are:
Danish: Accofil er anvendelig ved flere forskellige tilstande som:
English: Pull straight as shown in pictures 1 and 2.
Danish: Hiv den ligeud som vist på figur 1 og 2.
English: It is quite normal to have a number of courses of treatment with Accofil.
Danish: Det er helt normalt at have en række behandlingsforløb med Accofil.
English: Your healthcare professional should always record the exact product you are using.
Danish: Lægen skal altid registrere det nøjagtige produkt, som du anvender.
English: The needle guard will not activate unless the entire dose has been given.
Danish: Kanylebeskytteren aktiveres ikke, medmindre hele dosen er givet.
English: Use each syringe only for one injection.
Danish: Hver sprøjte må kun anvendes til én indsprøjtning.
English: Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present.
Danish: Bindende antistoffer optræder, som det kan forventes med alle biologiske lægemidler, men for nuværende har de ikke været forbundet med neutraliserende aktivitet.
English: Decreased Appetitee
Danish: Nedsat appetita
English: Your doctor or nurse will give you instructions on how to do this (see information below on instructions for injecting Accofil).
Danish: Din læge eller sygeplejerske vil give dig instruktioner om, hvordan du gør dette (se nedenfor om vejledning til injektion af Accofil).
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Hvis fristerne for indgivelse af en PSUR og opdatering af en RMP sammenfaldende, kan de indsendes på samme tid.
English: Accofil has not been tested in pregnant women.
Danish: Accofil er ikke blevet testet til gravide kvinder.
English: You do not have to remove the air bubble before injecting.
Danish: Du behøver ikke at fjerne luftboblen inden injektionen.
English: The marketing authorisation holder shall submit PSURs for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk.7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Manufacturer Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow,
Danish: Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow,
English: Your doctor will tell you why you are being treated with Accofil.
Danish: Din læge vil fortælle dig, hvorfor du bliver behandlet med Accofil.
English: There were no differences in the safety profiles for paediatric patients treated for SCN.
Danish: Der fandtes ingen forskelle med hensyn til sikkerhedsprofilen for pædiatriske patienter behandlet for SCN.
English: FR Accord Healthcare France SAS
Danish: Accord Healthcare France SAS
English: Spleen size should be evaluated regularly.
Danish: Miltstørrelsen bør vurderes regelmæssigt.
English: It is advisable to wait and see how you feel after taking Accofil and before driving or operating machinery.
Danish: Du tilrådes at vente og se, hvordan du har det, efter at have taget Accofil og inden kørsel eller betjening af maskiner.
English: Filgrastim is not recommended during pregnancy.
Danish: Filgrastim anbefales ikke under graviditet.
English: Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
Danish: Mulige interaktioner med andre hæmatopoietiske vækstfaktorer og cytokiner er endnu ikke blevet undersøgt i kliniske forsøg.
English: Effects of filgrastim on prenatal development have been studied in rats and rabbits.
Danish: Virkningerne af filgrastim på den prænatale udvikling er undersøgt hos rotter og kaniner.
English: Sixty-five percent of patients studied in a SCN trial program were under 18 years of age.
Danish: 65 procent af patienterne undersøgt i et SCN forsøgsprogram var under 18 år.
English: It belongs to a group of proteins called cytokines and is very similar to a natural protein (granulocyte-colony stimulating factor [G-CSF]) produced by your own body.
Danish: Det tilhører en gruppe af proteiner kaldet cytokiner og minder meget om et naturligt protein (granulocytkolonistimulerende faktor [G-CSF]), som produceres af din egen krop.
English: The timing of leukapheresis: 1 or 2 leukaphereses on days 5 and 6 which is often sufficient.
Danish: Timing af leukaferese:1 eller 2 leukafereser på dag 5 og 6, hvilket ofte er tilstrækkeligt.
English: You can also report side effects directly via the national reporting system listed in Appendix V By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Particular attention should be paid to haematological values and infectious diseases.
Danish: Opmærksomheden skal specielt været rettet mod hæmatologiske værdier og smittefarlige sygdomme.
English: This medicinal product must not be mixed with other medicinal products except those mentioned below.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, som er nævnt nedenfor.
English: Therefore, your doctor may decide that you should not use this medicine if you are breast-feeding.
Danish: Din læge kan derfor beslutte, at du ikke skal bruge denne medicin, hvis du ammer.
English: Your doctor will tell you when to stop using Accofil.
Danish: Din læge vil fortælle dig, hvornår du skal stoppe med at bruge Accofil.
English: If you are a stem cell donor, you must be aged between16 and 60 years.
Danish: Hvis du er stamcelledonor, skal du være i alderen 16 til 60 år.
English: Long-term treatment with Accofil is required for reduction in neutropenia.
Danish: Langvarig behandling med Accofil er nødvendig for en reduktion af neutropeni.
English: Splenomegaly is a direct effect of treatment with filgrastim.
Danish: Splenomegali er en direkte virkning af behandlingen med filgrastim.
English: Accofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).
Danish: Accofil er indiceret til mobilisering af perifere blodprogenitorceller (PBPC).
English: If there are particles in it, you must not use it. d.
Danish: Hvis den indeholder partikler, må du ikke bruge den.
English: Check the appearance of Accofil.
Danish: Kontroller Accofils udseende.
English: The amount of Accofil you need will depend on the condition you are taking Accofil for and on your bodyweight.
Danish: Den dosis Accofil, som du har brug for, vil afhænge af den tilstand, du tager Accofil for og af din kropsvægt.
English: Do not warm Accofil in any other way (for example, do not warm it in a microwave or in hot water).
Danish: Du må ikke opvarme Accofil på anden vis (for eksempel hverken i mikroovn eller i varmt vand).
English: The assessment of undesirable effects is based on the following frequency data:
Danish: Vurderingen af bivirkninger er baseret på følgende frekvens data:
English: Long term treatment with Accofil may be required to maintain a normal number of white cells in your blood.
Danish: Langvarig behandling med Accofil kan være nødvendig for at opretholde et normalt antal hvide blodlegemer i blodet.
English: The only consistently reported adverse event was musculoskeletal pain which is no different from the experience in the adult population.
Danish: Den eneste bivirkning, der vedvarende blev rapporteret, var muskel- og ledsmerter, hvilket ikke er forskelligt fra erfaringen hos den voksne population.
English: Abdominal palpation should be sufficient to detect abnormal increases in splenic volume.
Danish: Palpation af abdomen bør være tilstrækkelig til at detektere abnorme forstørrelser af milten.
English: These changes all reversed after discontinuation of treatment.
Danish: Alle disse ændringer svandt efter seponering.
English: This medicine is given by injection, either through an intravenous (IV) infusion (drip) or by a subcutaneous (SC) injection into the tissue just under the skin.
Danish: Dette lægemiddel gives som en injektion, enten som en intravenøs (IV) infusion (drop) eller som en subkutan (SC) injektion i vævet lige under huden.
English: Your doctor has prescribed Accofil for you to help your body make more white blood cells.
Danish: Lægen har ordineret Accofil til dig at hjælpe din krop med at producere flere hvide blodlegemer.
English: It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Danish: Det er vigtigt, at du ikke forsøger at tage en indsprøjtning selv, før du har fået den fornødne vejledning af en læge eller sygeplejerske.
English: This section contains information on how to give yourself an injection of Accofil.
Danish: Dette afsnit indeholder oplysninger om, hvordan du kan give dig selv indsprøjtninger med Accofil.
English: The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation (see picture 8).
Danish: Kanylebeskytteren vil automatisk dække kanylen, og der vil kunne høres et ”klik”, der bekræfter, at kanylebeskytteren er aktiveret (se billede 8).
English: In clinical trials in cancer patients musculoskeletal pain was mild or moderate in 10%, and severe in 3% of patients.
Danish: I kliniske forsøg hos kræftpatienter var muskuloskeletale smerter milde eller moderate hos 10 % og alvorlige hos 3 % af patienterne.
English: Accofil treatment will last for 4 to 5 days.
Danish: Accofil behandlingen vil fortsætte i 4 til 5 dage.
English: The effects of Accofil overdose have not been established.
Danish: Virkningerne efter overdosering af Accofil er ikke klarlagt.
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Danish: Derfor bør størrelsen af milten monitoreres nøje (f.eks. ved en klinisk undersøgelse eller ultralyd).
English: There are no or limited data from the use of filgrastim in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af filgrastim til gravide kvinder.
English: Special warnings and precautions across indications
Danish: Særlige advarsler og forsigtighedsregler på tværs af indikationer
English: Contact your doctor to discuss when you should inject the next dose.
Danish: Kontakt din læge for at diskutere, hvonår du skal injicere den næste dosis.