FrancophonIA/ELRC3.0 huggingface dataset:
English: In the tenofovir disoproxil treatment arm, 7% of patients discontinued treatment due to an adverse event; 9% of patients experienced a confirmed increase in serum creatinine of ≥ 0.5 mg/dl or confirmed serum phosphate of < 2 mg/dl through week 48; there were no statistically significant differences between the combined tenofovir-containing arms and the entecavir arm. After 168 weeks, 16% (7/45) of the tenofovir disoproxil group, 4% (2/45) of the emtricitabine plus tenofovir disoproxil group, and 14% (3/22) of the entecavir group experienced tolerability failure.
Danish: I behandlingsarmen med tenofovirdisoproxil seponerede 7 % af patienterne behandlingen på grund af en bivirkning, 9 % af patienterne fik bekræftet forhøjelse i serumkreatinin på ≥ 0,5 mg/dl eller bekræftet serumphosphat på < 2 mg/dl til og med uge 48.
English: Tenofovir disoproxil phosphate is the phosphate salt of the prodrug tenofovir disoproxil.
Danish: Virkningsmekanisme og farmakodynamisk virkning Tenofovirdisoproxilfumarat er fumaratsaltet af et prodrug af tenofovirdisoproxil.
English: What Tenofovir disoproxil Zentiva contains
Danish: Tenofovir disoproxil Zentiva.
English: Increased plasma concentrations of tenofovir resulting from coadministration of tenofovir disoproxil, sofosbuvir/velpatasvir/voxil aprevir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovirdisoproxil, sofosbuvir/velpatasvir/voxil aprevir og darunavir/ritonavir kan øge risikoen for bivirkninger relateret til tenofovirdisoproxil, herunder nyrerelaterede bivirkninger.
English: + Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.
Danish: + Emtricitabin/tenofovirdisoprox il (200 mg/245 mg q.d.
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and lopinavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovirdisoproxil, sofosbuvir/velpatasvir og lopinavir/ritonavir kan øge risikoen for bivirkninger relaterede til tenofovirdisoproxil, herunder nyrerelaterede bivirkninger.
English: + Efavirenz/Emtricitabine/Tenofo vir disoproxil (600 mg/200 mg/245 mg q.d.)
Danish: + Efavirenz/emtricitabin/tenofov irdisoproxil (600 mg/200 mg/245 mg q.d.)
English: Increased plasma concentrations of tenofovir resulting from coadministration of tenofovir disoproxil, ledipasvir/sofosbuvir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovirdisoproxil, ledipasvir/sofosbuvir og darunavir/ritonavir kan øge risikoen for bivirkninger relaterede til tenofovirdisoproxil, herunder nyrerelaterede bivirkninger.
English: Normal ALT ≥ 2 point decrease in CPT from baseline n (%)
Danish: Gennemsnitlig stigning (%) i BMD for columna lumbalis
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and atazanavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovirdisoproxil, sofosbuvir/velpatasvir og atazanavir/ritonavir kan øge risikoen for bivirkninger relaterede til tenofovirdisoproxil, herunder nyrerelaterede bivirkninger.
English: • feeling sick (nausea), being sick (vomiting) and stomach pain.
Danish: • kvalme, opkastning og mavesmerter
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovirdisoproxil, sofosbuvir/velpatasvir og darunavir/ritonavir kan øge risikoen for bivirkninger relaterede til tenofovirdisoproxil, herunder nyrerelaterede bivirkninger.
English: + Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
Danish: + Emtricitabin/tenofovirdisoprox il (200 mg/245 mg q.d.)
English: Renal impairment
Danish: Påvirkning af nyrer
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Tenofovir disoproxil Zentiva indeholder lactosemonohydrat Kontakt lægen, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: These symptoms generally develop in a rapid fashion.
Danish: Disse symptomer udvikles som regel hurtigt.
English: You can use:
Danish: Du kan bruge:
English: There is no evidence that such an interaction would be harmful.
Danish: Der er ingen evidens for, at en sådan interaktion ville være skadelig.
English: These elevations are transient and return to baseline.
Danish: Disse stigninger er forbigående og vender tilbage til baseline.
English: The youngest age group (0-5
Danish: Den yngste aldersgruppe (0-5 år)
English: The experience in children is limited.
Danish: Der er begrænset erfaring hos børn.
English: Wash your hands thoroughly.
Danish: Vask hænderne grundigt.
English: You should talk to your doctor about your risks of developing cancers of the blood.
Danish: Du bør tale med lægen om din risiko for at udvikle blodkræft.
English: The relevance of these findings for humans is not known.
Danish: Relevansen af disse fund for mennesker er ukendt.
English: These could be signs of a severe allergic reaction.
Danish: Det kan være tegn på en alvorlig allergisk reaktion.
English: • some changes may occur in your blood, but these will be detected by routine blood tests.
Danish: • visse forandringer i blodet kan forekomme, men de vil blive opdaget i forbindelse med de rutinemæssige blodprøver.
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Danish: Som det er tilfældet med alle terapeutiske proteiner, er der risiko for immunogenicitet.
English: Tell your doctor if you experience those symptoms.
Danish: Kontakt lægen, hvis du oplever disse symptomer.
English: MedDRA system organ class
Danish: MedDRA systemorganKlasse
English: It is important to tell your doctor if you:
Danish: Det er vigtigt, at du fortæller det til lægen, hvis du
English: Date of first authorisation: Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: Dato for seneste fornyelse:
English: • It is important that you do not try to give yourself the injection unless you have received training from your doctor or healthcare provider.
Danish: • Det er vigtigt, at du ikke forsøger at give dig selv en injektion, hvis du ikke er blevet oplært i det af lægen eller sundhedspersonalet.
English: • Outer area of upper arm (only if someone else is giving you the injection).
Danish: • Ydersiden af overarmen (hvis en anden giver dig injektionen).
English: If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days.
Danish: I tilfælde af en alvorlig allergisk reaktion skal der administreres passende behandling, og patienten skal følges tæt i flere dage.
English: The concentration is 10 mg/ml based on protein only**.
Danish: Koncentrationen er 10 mg/ml baseret på protein alene**.
English: Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present.
Danish: Bindende antistoffer forekommer, som det er forventeligt med alle biologiske lægemidler; til dato har de imidlertid ikke været forbundet med neutraliserende aktivitet.
English: Your white blood cell count may become high for a short period of time.
Danish: Antallet af hvide blodlegemer kan blive højt i en kort periode.
English: Your doctor will tell you what you can take to ease the bone pain.
Danish: Lægen vil fortælle dig, hvad du kan tage for at lindre knoglesmerterne.
English: If white blood cells fall to a low level there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.
Danish: Hvis antallet af hvide blodlegemer falder til et lavt niveau, vil der eventuelt ikke være nok af dem tilbage i kroppen til at bekæmpe bakterier, og du kan have større risiko for at få en infektion.
English: Do not try to warm the syringe by using a heat source such as hot water or microwave.
Danish: Forsøg ikke at opvarme sprøjten ved hjælp af en varmekilde, f.eks. under varmt vand eller i mikrobølgeovnen.
English: Median time to recovery from severe neutropenia was estimated as 22 days in both treatment groups.
Danish: Mediantiden til restitution efter svær neutropeni blev estimeret til 22 dage i begge behandlingsgrupper.
English: (≥ 1/1,000 to
Danish: (≥ 1/1.000 til
English: Your doctor or nurse will show you how to inject yourself.
Danish: Lægen eller sundhedspersonalet vil vise dig, hvordan du giver dig selv en injektion.
English: Grasustek is for use in adults aged 18 and over.
Danish: Grasustek er beregnet til brug hos voksne over 18 år.
English: Medicines should be disposed of in accordance with local requirements.
Danish: Medicin skal bortskaffes i henhold til de lokale retningslinjer.
English: White blood cells are important as they help your body fight infection.
Danish: Hvide blodlegemer er vigtige, fordi de hjælper kroppen med at bekæmpe infektioner.
English: This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler, i særdeleshed natriumchloridopløsninger.
English: • Grasustek is given as an injection into the tissue just under the skin (subcutaneous use).
Danish: • Grasustek gives som en injektion i vævet lige under huden (subkutan anvendelse).
English: The potency of this product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class.
Danish: Dette lægemiddels potens bør ikke sammenlignes med potensen af andre pegylerede eller ikke-pegylerede proteiner i samme terapeutiske klasse.
English: The frequency category was estimated from a statistical calculation based upon 1,576 patients receiving pegfilgrastim in nine randomised clinical trials.
Danish: Hyppighedskategorien er blevet estimeret ud fra en statistisk beregning baseret på 1.576 patienter, der fik pegfilgrastim i ni randomiserede kliniske forsøg.
English: There is insufficient information on the excretion of pegfilgrastim / metabolites in human milk, a risk to the newborns/infants cannot be excluded.
Danish: Der er utilstrækkelige oplysninger om udskillelsen af pegfilgrastim/metabolitter i human mælk; en risiko for nyfødte/spædbørn kan ikke udelukkes.
English: If leukocyte counts exceed 50 x 109/L after the expected nadir, this medicinal product should be discontinued immediately.
Danish: Hvis leukocyttallet overstiger 50 x 109/l efter det forventede nadir, bør dette lægemiddel omgående seponeres.
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Danish: Derfor bør miltstørrelsen monitoreres nøje (f.eks. klinisk undersøgelse, ultralyd).
English: This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dose regimens.
Danish: Dette lægemiddel bør ikke anvendes til at øge dosen af cytotoksisk kemoterapi ud over de etablerede doseringsregimer.
English: Store in a refrigerator (2°C-8°C).
Danish: Opbevares i køleskab (2 °C-8 °C).
English: USV Private Limited D-115, TTC Industrial Area, Shirvane Navi Mumbai - 400706, Maharashtra, INDIA
Danish: USV Private Limited D-115, TTC Industrial Area, Shirvane Navi Mumbai - 400706, Maharashtra, INDIEN
English: If you have forgotten a dose of Grasustek, contact your doctor to discuss when you should inject the next dose.
Danish: Hvis du har glemt en dosis Grasustek, skal du kontakte lægen for at spørge, hvornår du skal tage den næste dosis.
English: ** The concentration is 20 mg/ml if the PEG moiety is included.
Danish: ** Koncentrationen er 20 mg/ml, hvis PEG-delen inkluderes.
English: Avoid vigorous shaking.
Danish: Undgå kraftig omrysten.
English: If you develop or are likely to develop cancers of the blood, you should not use Grasustek, unless instructed by your doctor.
Danish: Hvis du udvikler eller har sandsynlighed for at udvikle blodkræft, bør du ikke bruge Grasustek, medmindre lægen anviser det.
English: This may be a sign of a problem with your spleen (splenomegaly)
Danish: Det kan være et tegn på problemer med milten (splenomegali).
English: Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30 °C) it must either be used within 3 days or disposed of.
Danish: Når sprøjten er taget ud af køleskabet og har opnået rumtemperatur (ikke over 30 °C), skal den enten anvendes inden for 3 dage eller bortskaffes.
English: No adverse events directly attributable to this degree of leukocytosis have been reported.
Danish: Der er ikke rapporteret om nogen bivirkninger, der direkte kan tilskrives denne grad af leukocytose.
English: Polska Alvogen Pharma Sp. Z o.o.
Danish: Alvogen Pharma Sp. Z o.o.
English: The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and musculoskeletal pain (common).
Danish: De hyppigst indberettede bivirkninger var knoglesmerter (meget almindelig [≥ 1/10]) og muskuloskeletale smerter (almindelig).
English: Your doctor may decide that it would be more convenient for you to inject Grasustek yourself.
Danish: Lægen kan vurdere, at det er mere belejligt for dig, hvis du giver dig selv injektionerne med Grasustek.
English: Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow.
Danish: Human granulocytkolonistimulerende faktor (G-CSF) er et glykoprotein, der regulerer produktionen og frigivelsen af neutrofiler fra knoglemarven.
English: Long term outcome was not studied (see section 4.4).
Danish: Udfaldet på lang sigt blev ikke undersøgt (se pkt.
English: Such elevation in white blood cells is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of this medicinal product.
Danish: En sådan stigning i leukocyttallet er forbigående og ses typisk 24 til 48 timer efter administration og er i overensstemmelse med lægemidlets farmakodynamiske virkninger.
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 til Lægemiddelstyrelsen via det national rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: In animal models concomitant administration of pegfilgrastim and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Danish: dyremodeller har samtidig administration af pegfilgrastim og 5-fluorouracil (5-FU) eller andre antimetabolitter vist sig af potensere myelosuppression.
English: It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.
Danish: Det tilhører en gruppe proteiner, der kaldes for cytokiner, og minder meget om et naturligt protein (granulocytkolonistimulerende faktor), som kroppen selv producerer.
English: Step 3: Inject
Danish: Trin 3: Injektion
English: • The medicine is cloudy or there are particles in it.
Danish: • Medicinen er uklar eller indeholder partikler.
English: Pharmacotherapeutic group: immunostimulants, colony stimulating factors; ATC Code: L03AA13.
Danish: Farmakoterapeutisk klassifikation: immunmodulerende midler, kolonistimulerende faktorer; ATCkode: L03AA13.
English: Grasustek is a biosimilar medicinal product.
Danish: Grasustek er et biosimilært lægemiddel.
English: The needle has flexible, rigid needle shield.
Danish: Kanylen har et fleksibelt, rigidt kanylehylster.
English: Please tell your doctor immediately if you have any of the following or combination of the following side effects:
Danish: Kontakt omgående lægen, hvis du får en eller flere af følgende bivirkninger:
English: • breathing problems.
Danish: • vejrtrækningsproblemer.
English: Clean the injection site with an alcohol wipe.
Danish: Rengør injektionsstedet med en alkoholserviet.
English: • if you are allergic to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for pegfilgrastim, filgrastim, E. coli-deriverede proteiner eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Danish: 4.8, 5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering Administration
English: INSERT the needle into skin.
Danish: INDSÆT kanylen i huden.
English: The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who received
Danish: Pegfilgrastims farmakokinetik blev undersøgt hos 37 pædiatriske patienter med sarkom, som fik
English: Prepare and clean your injection site.
Danish: Klargør og rengør dit injektionssted.
English: Do not try to inject yourself if you have not been trained.
Danish: Du må ikke forsøge at indsprøjte lægemidlet selv, hvis du ikke er blevet oplært i det.
English: Do not inject into areas where the skin is tender, bruised, red, or hard.
Danish: Giv ikke injektionen på områder, hvor huden er øm, rød eller hård eller har blå mærker.
English: In clinical trials, pegfilgrastim has been safely administered 14 days before chemotherapy.
Danish: I kliniske forsøg er pegfilgrastim blevet administreret i sikkerhed 14 dage før kemoterapi.
English: Instructions for use: Guide to parts Syringe before administration
Danish: Brugsanvisning: Oversigt over dele: Injektionssprøjte inden administration
English: 2 This adverse reaction was identified through post-marketing surveillance of pegfilgrastim but not observed in randomised, controlled clinical trials in adults.
Danish: 2 Denne bivirkning er identificeret efter markedsføringen af pegfilgrastim, men blev ikke set i randomiserede, kontrollerede kliniske forsøg hos voksne.
English: Injection site pain Non-cardiac chest pain
Danish: Smerte på injektionsstedet Ikke-kardielle brystsmerter
English: The entire dose has to be administered to trigger the guard.
Danish: Hele dosen skal indgives for at aktivere sikringen.
English: Do not shake Grasustek vigorously as this may affect its activity.
Danish: Du må ikke omryste Grasustek kraftigt, da det kan påvirke lægemidlets virkning.
English: Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli.
Danish: Pegfilgrastim er et protein, der bliver fremstillet ved hjælp af bioteknologi i en bakterie, der hedder E.coli.
English: Your doctor has given you Grasustek to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
Danish: Lægen har givet dig Grasustek for at få knoglemarven (en bestanddel i knoglerne, der producerer blodlegemer) til at producere flere hvide blodlegemer, som hjælper kroppen med at bekæmpe infektion.
English: Healthcare professionals only The trade name of the medicine should be clearly recorded in the patient file.
Danish: Til læger og sundhedspersonale Lægemidlets handelsnavn skal registreres tydeligt i patientjournalen.
English: Single doses of 300 μg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions.
Danish: Der er blevet administreret enkeltdoser på 300 μg/kg subkutant til et begrænset antal raske frivillige og patienter med ikke-småcellet lungecancer uden alvorlige bivirkninger.
English: In rat studies, it was shown that pegfilgrastim may cross the placenta.
Danish: I rottestudier blev det påvist, at pegfilgrastim kan krydse placenta.
English: This should be considered when interpreting bone-imaging results.
Danish: Dette bør tages i betragtning ved tolkning af billeddiagnostik af knoglerne.
English: See the end of section 4 for how to report side effects
Danish: Se sidst i punkt 4, hvordan du indberetter bivirkninger.>
English: Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Grasustek.
Danish: Utilsigtet nedfrysning i en enkeltperiode på højst 24 timer påvirker ikke stabiliteten af Grasustek.
English: INFORMATION IN BRAILLE Grasustek 6 mg
Danish: INFORMATION I BRAILLESKRIFT Grasustek 6 mg
English: However, the long-term effects of pegfilgrastim have not been established in AML; therefore, it should be used with caution in this patient population.
Danish: Pegfilgrastims langsigtede virkninger hos patienter med AML er imidlertid ikke klarlagt; derfor bør det anvendes med forsigtighed i denne patientpopulation.
English: Turn the plunger to move the label into a position where you can remove the syringe label.
Danish: Drej på stemplet for at flytte etiketten til et sted, hvor du kan tage sprøjteetiketten af.
English: Splenomegaly, generally asymptomatic, is uncommon.
Danish: Splenomegali forekommer med hyppigheden ikke almindelig og er som regel asymptomatisk.
English: (≥ 1/100 to < 1/10)
Danish: (≥ 1/100 til <
English: Uncommon cases of Sweet's syndrome have been reported, although in some cases underlying haematological malignancies may play a role.
Danish: Sweets syndrom er blevet indberettet med hyppigheden ikke almindelig, men i nogle tilfælde kan underliggende hæmatologiske maligniteter spille en rolle.
English: Limited data indicate that the pharmacokinetics of pegfilgrastim in elderly subjects (> 65 years) is similar to that in adults.
Danish: Begrænsede data viser, at pegfilgrastims farmakokinetik er den samme hos ældre personer (> 65 år) som hos voksne.
English: Always use Grasustek exactly as your doctor has told you.
Danish: Brug altid Grasustek nøjagtigt efter lægens anvisning.
English: This leaflet was last revised in {MM/YYYY}
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}
English: Grasustek left at room temperature for more than 72 hours should be discarded.
Danish: Hvis Grasustek efterlades ved rumtemperatur i mere end 72 timer, skal det bortskaffes.
English: Therefore, physicians should use caution when prescribing pegfilgrastim in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicinal product with splenic enlargement and vaso-occlusive crisis.
Danish: Læger bør derfor udvise forsigtighed ved ordination af pegfilgrastim hos patienter med seglcelletræk eller seglcellesygdom og monitorere relevante kliniske parametre og laboratoriestatus og være opmærksomme på den mulige sammenhæng mellem dette lægemiddel og miltforstørrelse og vaso-okklusiv krise.
English: These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease.
Danish: Disse blodlegemer er meget følsomme over for virkningen af kemoterapi, som kan få antallet af disse blodlegemer til at falde.
English: Grasustek contains the active substance pegfilgrastim.
Danish: Grasustek indeholder det aktive stof pegfilgrastim.
English: Similarly to filgrastim, neutrophils produced in response to pegfilgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Danish: På samme måde som med filgrastim udviste neutrofiler, der blev produceret som respons på pegfilgrastim, normal eller øget funktion, påvist ved tests af kemotaktisk og fagocytisk funktion.