FrancophonIA/ELRC3.0 huggingface dataset:
English: These antibodies have been shown to cross-react with all epoetins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to epoetin theta (see section 4.8).
Danish: Disse antistoffer har vist sig at give krydsreaktion med alle epoetiner, og patienter med mistænkte eller påviste neutraliserende antistoffer mod erytropoietin bør ikke skifte behandling til epoetin theta (se pkt.
English: If you forget to use Biopoin
Danish: Hvis du har glemt at bruge Biopoin
English: For the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at a temperature not above 25 °C for a single period of up to 7 days without exceeding the expiry date.
Danish: Til ambulant brug kan patienten tage præparatet ud af køleskabet og opbevare det ved en temperatur, der ikke må overstige 25 °C, i en enkelt periode på op til 7 dage uden at overskride udløbsdatoen.
English: Following subcutaneous injection of 40 IU/kg body weight epoetin theta at three different sites (upper arm, abdomen, thigh) in healthy volunteers, similar plasma level profiles were observed.
Danish: Efter subkutan injektion af 40 IE epoetin theta pr. kg legemsvægt tre forskellige steder (overarm, abdomen, lår) hos raske forsøgspersoner sås omtrent samme profil for plasmakoncentrationen.
English: Allergic reactions such as skin rash, raised areas of the skin that itch and severe allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported (not known, frequency cannot be estimated from the available data).
Danish: Der er indberettet allergiske reaktioner i form af hududslæt, hævede hudområder med kløe og alvorlige allergiske reaktioner med svækkelse, blodtryksfald, vejrtrækningsbesvær og hævelser i ansigtet (ikke kendt, hyppigheden kan ikke estimeres ud fra forhåndenværende data).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Biopoin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med Biopoin skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: These may be signs of severely elevated blood pressure (common in patients with chronic renal failure, may affect up to 1 in 10 people), even if your blood pressure is usually normal or low.
Danish: Det kan være tegn på stærkt forhøjet blodtryk (det sker hyppigt hos patienter med kronisk nyresvigt, kan forekomme hos op til 1 ud af 10 personer), selv om du plejer at have normalt eller lavt blodtryk.
English: Non-clinical data with epoetin theta reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Danish: Prækliniske data for epoetin theta viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi og toksicitet efter gentagne doser.
English: Symptomatic anaemia associated chronic renal failure Data from correction phase studies in 284 chronic renal failure patients show that the haemoglobin response rates (defined as haemoglobin levels above 11 g/dl at two consecutive measurements) in the epoetin theta group (88.4% and 89.4% in studies in patients on dialysis and not yet undergoing dialysis, respectively) were comparable to epoetin beta (86.2% and 81.0%, respectively).
Danish: Symptomatisk anæmi i forbindelse med kronisk nyresvigt Data fra studier af korrektionsfasen hos 284 patienter med kronisk nyresvigt viser, at hæmoglobins responsrate (defineret som hæmoglobinniveauer over 11 g/dl ved to fortløbende målinger) i epoetin theta-gruppen (hhv. 88,4 % og 89,4 % i studier med patienter, som var i dialyse eller endnu ikke var i dialyse) var sammenlignelig med epoetin beta (hhv. 86,2 % og 81,0 %).
English: Symptoms of influenza-like illness such as fever, chills and asthenic conditions have been reported.
Danish: Der er rapporteret symptomer på influenzalignende sygdom i form af feber, kuldegysninger og asteniske tilstande.
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på den ydre karton og på den fyldte injektionssprøjte efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Put the needle fully into the skin as shown by your doctor or nurse.
Danish: Stik kanylen helt ind i huden, sådan som lægen eller sygeplejersken har vist dig.
English: Other medicines and Biopoin
Danish: Brug af anden medicin sammen med Biopoin
English: PRCA means that the body has stopped or reduced the production of red blood cells which causes severe anaemia.
Danish: Ved PRCA er kroppen holdt op med at danne eller danner færre røde blodlegemer, og det kan give alvorlig anæmi.
English: In patients with chronic renal failure, the maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
Danish: Hos patienter med kronisk nyresvigt bør hæmoglobin-koncentrationen under vedligeholdelsesbehandling ikke overstige den øvre grænse for hæmoglobin, som er anbefalet i pkt.
English: Do not touch the needle or push the plunger.
Danish: Pas på ikke at røre ved kanylen eller skubbe til stemplet.
English: In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
Danish: Der var ingen forskel i det åbne studie mellem total overlevelse blandt patienter, der fik rekombinant humant erytropoietin og kontrolpersoner.
English: Some of the information required for using the pre-filled syringe can be found at the end of this package leaflet (see section “7.
Danish: Du kan finde nogle oplysninger om, hvordan du skal bruge den fyldte injektionssprøjte, sidst i indlægssedlen (se punkt “7.
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI: 0.99, 1.18; 42 trials and 8,167 patients).
Danish: En metaanalyse af data for total overlevelse gav en hazard ratio af risikoforholdet på 1,08 til fordel for kontrolpersonerne (95 % KI: 0,99 - 1,18; 42 studier og 8167 patienter).
English: If necessary, your doctor will increase your dose at monthly intervals.
Danish: Om nødvendigt kan lægen øge dosis en gang om måneden.
English: These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Danish: I disse studier sås en vedvarende uafklaret signifikant højere mortalitet hos patienter, som havde anæmi i forbindelse med en række almindelige cancerformer, og som fik rekombinant erytropoietin, sammenlignet med kontrolpersoner.
English: Do not remove the needle cover from the syringe until you are ready to inject.
Danish: Fjern først kanylehylsteret fra sprøjten, når du er parat til at give injektionen.
English: A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin and perform anti-erythropoietin antibody testing.
Danish: En paradoks reduktion i hæmoglobin og udvikling af svær anæmi i forbindelse med lavt retikulocyttal bør medføre seponering af epoetin og bestemmelse af anti-erytropoietin-antistoffer.
English: If you are a patient with chronic renal failure, and particularly if you do not respond properly to Biopoin, your doctor will check your dose of Biopoin because repeatedly increasing your dose of Biopoin if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
Danish: Hvis du har kronisk nyresvigt, og især hvis du ikke reagerer godt på Biopoin, vil lægen kontrollere din Biopoin-dosis, da du har større risiko for at få problemer med hjertet eller blodårerne, hvis din Biopoin-dosis skal øges gentagne gange, fordi du ikke reagerer på behandlingen.
English: Patients should be monitored closely to ensure that the lowest approved effective dose of epoetin theta is used to provide adequate control of the symptoms of anaemia whilst maintaining a haemoglobin concentration below or at 12 g/dl (7.45 mmol/l).
Danish: Patienterne bør monitoreres nøje for at sikre, at den laveste godkendte, effektive dosis epoetin theta, der kan kontrollere symptomerne på anæmi i tilstrækkelig grad, anvendes, mens der opretholdes en hæmoglobinkoncentration under eller på 12 g/dl (7,45 mmol/l).
English: Therefore, in patients treated with epoetin theta, special care should be taken to monitor closely and control blood pressure.
Danish: Derfor er det vigtigt, at patienter i behandling med epoetin theta monitoreres nøje og får målt deres blodtryk.
English: Patients on epoetin theta therapy can experience an increase in blood pressure or aggravation of existing hypertension particularly during the initial treatment phase.
Danish: Patienter, der får epoetin theta, kan opleve blodtryksstigning eller forværring af eksisterende hypertension, navnlig i den indledende fase af behandlingen.
English: Do not touch the needle or needle shield or push the plunger (see picture 5).
Danish: Pas på ikke at røre ved kanylen eller kanylebeskytteren eller skubbe til stemplet (se figur 5).
English: Not known in patients with chronic renal failure (frequency cannot be estimated from the available data) - Cases of a condition called pure red cell aplasia (PRCA) have been reported.
Danish: Ikke kendt hos patienter med kronisk nyresvigt (hyppigheden kan ikke estimeres ud fra forhåndenværende data) - Der er indberettet tilfælde af en tilstand, som kaldes aplasi, med umodne røde blodlegemer (pure red cell aplasia eller PRCA).
English: Non-clinical data with other epoetins reveal no special hazard for humans based on conventional studies of genotoxicity and toxicity to reproduction.
Danish: Prækliniske data for andre epoetiner viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af genotoksicitet og reproduktionstoksicitet.
English: Treatment with epoetin theta should be temporarily discontinued if haemoglobin levels exceed 13 g/dl (8.07 mmol/l).
Danish: Behandling med epoetin theta bør midlertidigt indstilles, hvis hæmoglobinkoncentrationen overstiger 13 g/dl (8,07 mmol/l).
English: Therefore, your doctor may decide that you should not use this medicine if you are breast-feeding.
Danish: Lægen kan derfor vurdere, at du ikke må bruge medicinen, mens du ammer.
English: Shunt thrombosis may occur, especially in patients who have a tendency to hypotension or whose arterio-venous fistulae exhibit complications (e.g. stenoses, aneurisms) (see section 4.4).
Danish: Der kan dannes shunttrombose, især hos patienter med tendens til hypotension, eller hos hvem en arteriovenøs fistel medfører komplikationer (fx stenoser, aneurismer) (se pkt.
English: The maximum dose should not exceed 60,000 IU.
Danish: Den maksimale dosis bør ikke overstige 60.000 IE.
English: Once hypertension has been controlled with more intensified therapy, epoetin theta therapy should be re-started at a reduced dose.
Danish: Når blodtrykket er bragt under kontrol med en mere intensiv behandling, kan behandlingen med epoetin theta genoptages med en lavere dosis.
English: If this blood parameter becomes too high, heart or vascular problems might occur, increasing the risk of death.
Danish: Hvis dit hæmoglobintal er for højt, kan der opstå hjerte- eller karproblemer og dermed en øget risiko for dødsfald.
English: Patients on haemodialysis will usually receive the injection at the end of dialysis via an arterio-venous fistula.
Danish: Patienter i hæmodialyse får sædvanligvis indsprøjtningen efter dialysen i en arteriovenøs fistel.
English: Misuse of epoetin theta by healthy persons may lead to an excessive increase in haemoglobin and haematocrit.
Danish: Raske personers misbrug af epoetin theta kan føre til en voldsom stigning i hæmoglobin- og hæmatokritværdier.
English: Blood pressure should be controlled adequately before initiation and during therapy to avoid acute complications, such as hypertensive crisis with encephalopathy-like symptoms (e.g. headaches, confused state, speech disturbances, impaired gait) and related complications (seizures, stroke), which may also occur in individual patients with otherwise normal or low blood pressure.
Danish: Der bør udføres passende blodtrykskontrol før indledning af behandlingen og i løbet af behandlingen for at undgå akutte komplikationer i form af hypertensiv krise med encefalopatilignende symptomer (fx hovedpine, forvirring, taleforstyrrelser, gangbesvær) og beslægtede komplikationer (krampeanfald, slagtilfælde), hvilket også kan forekomme hos individer, som ellers har normalt eller lavt blodtryk.
English: The pharmacokinetics of epoetin theta have been examined in healthy volunteers, in patients with chronic renal failure and in cancer patients receiving chemotherapy.
Danish: Epoetin thetas farmakokinetik er undersøgt hos raske forsøgspersoner, hos patienter med kronisk nyresvigt og hos cancerpatienter, der fik kemoterapi.
English: Skin reactions such as rash, pruritus or injection site reactions may occur.
Danish: Der kan forekomme hudreaktioner så som udslæt, pruritus eller reaktioner ved injektionsstedet.
English: The use of this medicine by healthy people can excessively increase certain blood parameters and in so doing cause problems with the heart or blood vessels that can be life threatening.
Danish: Hvis raske får dette lægemiddel, kan deres blodværdier stige alt for voldsomt, hvilket kan give problemer med hjertet eller blodkarrene og være livstruende.
English: Press the injection site with a piece of gauze bandage or a sterile gauze swab for several seconds.
Danish: Pres et stykke gazebind eller nogle stykker steril gaze mod injektionsstedet i flere sekunder.
English: Caution should be exercised with escalation of epoetin theta doses in patients with chronic renal failure.
Danish: Der skal udvises forsigtighed, når dosis af epoetin theta optrappes hos patienter med kronisk nyresvigt.
English: Treatment for anaemia is given to adult patients with chronic renal failure or to adult patients with non-myeloid cancer (cancer not originating in the bone marrow) who at the same time are receiving chemotherapy (medicines to treat cancer).
Danish: Behandlingen for anæmi gives til voksne patienter med kronisk nyresvigt eller voksne patienter med non-myeloid kræft (kræft, som ikke udspringer af knoglemarven), som samtidig får kemoterapi (kræftmedicin).
English: Erythropoietin is a growth factor that primarily stimulates red cell production.
Danish: Erytropoietin er en vækstfaktor, der primært stimulerer dannelse af røde blodlegemer.
English: ≥ 1/100 to < 1/10;
Danish: ≥1/100 til <1/10
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10,441 patients).
Danish: En metaanalyse af data for samlet overlevelse gav et estimat af hazard ratio på 1,06 til fordel for kontrolgruppen (95% KI: 1,00 - 1,12; 53 studier og 13.933 patienter); for de cancerpatienter, der fik kemoterapi, var hazard ratio for samlet overlevelse 1,04 (95% KI: 0,97 - 1,11; 38 studier og 10.441 patienter).
English: A rise in haemoglobin of greater than 2 g/dl (1.24 mmol/l) over a four week period should be avoided.
Danish: En stigning i hæmoglobin på over 2 g/dl (1,24 mmol/l) i løbet af 4 uger bør undgås.
English: The needle shield will retract completely when you insert the needle into the skin (see picture 10).
Danish: Kanylebeskytteren trækkes automatisk helt tilbage, når du sætter kanylen i huden (se figur 10).
English: If typical causes of non-response are excluded, and the patient has a sudden drop in haemoglobin associated with reticulocytopenia, an examination of anti-erythropoietin antibodies and the bone marrow for diagnosis of pure red cell aplasia should be considered.
Danish: Hvis de typiske årsager til manglende respons er udelukket, og patienten får et pludseligt fald i hæmoglobin forbundet med reticulocytopeni, bør det overvejes at undersøge patienten for antistoffer mod erytropoietin og undersøge knoglemarven for at afklare, om der er tale om aplasi med umodne røde blodlegemer (pure red cell aplasia - PRCA).
English: In patients with chronic renal failure undergoing haemodialysis, the elimination half-life of epoetin theta is 6 hours after single dosing and 4 hours in steady state after repeated intravenous administration of 40 IU/kg body weight epoetin theta three times weekly.
Danish: Hos patienter med kronisk nyresvigt, der er i hæmodialyse, er epoetin thetas halveringstid 6 timer efter en enkelt dosis og 4 timer ved steady state efter gentagen intravenøs administration af 40 IE/kg legemsvægt tre gange ugentligt.
English: This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, i.e. essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. fyldt injektionssprøjte, d.v.s. den er i det væsentlige natriumfri.
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Hudreaktioner*
English: There is a cap at the end of the needle container.
Danish: Der sidder en hætte for enden af kanylebeholderen.
English: Very rare: Not known:
Danish: Meget sjældne: Ikke kendt: kan ikke estimeres ud fra forhåndenværende data
English: If you are being treated with Biopoin, the dose of the anticoagulant medicine may have to be increased.
Danish: Hvis du får Biopoin, kan det være nødvendigt at øge din dosis af den blodfortyndende medicin.
English: The recommended initial dose is 20,000 IU, independent of bodyweight, given once-weekly.
Danish: Den rekommanderede initialdosis er 20.000 IE uanset legemsvægt, som gives en gang ugentligt.
English: Patients who do not have to undergo dialysis are usally given the injections under the skin.
Danish: Patienter, som ikke er i dialyse, får sædvanligvis indsprøjtningerne i underhuden.
English: Biopoin is a clear and colourless solution for injection in pre-filled syringe along with an injection needle.
Danish: Biopoin er en klar og farveløs injektionsvæske i fyldt injektionssprøjte med kanyle.
English: Not known in cancer patients (frequency cannot be estimated from the available data) - Thromboembolic events, e.g. increase in blood clots.
Danish: Ikke kendt hos kræftpatienter (hyppigheden kan ikke estimeres ud fra forhåndenværende data) - (Øget) forekomst af blodpropper.
English: This medicine is given as an injection using a pre-filled syringe.
Danish: Medicinen gives som en indsprøjtning ved hjælp af en fyldt injektionssprøjte.
English: In the case of overdose, polycythaemia can occur.
Danish: Der kan forekomme polycytæmi i forbindelse med overdosering.
English: In clinical trials, an increased risk of death and serious cardiovascular events was observed when epoetins were administered to target a haemoglobin level in excess of 12 g/dl (7.45 mmol/l).
Danish: I kliniske studier sås en øget risiko for dødsfald og alvorlige kardiovaskulære hændelser, når epoetin blev anvendt til behandling af hæmoglobinværdier over 12 g/dl (7,45 mmol/l).
English: Push the safety shield towards the needle (see picture 12).
Danish: Skub sikkerhedskappen ned mod kanylen (se figur 12).
English: Frequency groupings are defined according to the following convention:
Danish: Bivirkningerne nedenfor i tabel 1 er inddelt efter systemorganklasse og anført med hyppighed i henhold til følgende konvention:
English: If there are air bubbles present, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe.
Danish: Bank let på sprøjten med fingrene, indtil boblerne stiger til vejrs.
English: In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered (see sections 4.2 and
Danish: Hos patienter med dårligt hæmoglobinrespons på epoetiner bør alternative forklaringer på det dårlige respons overvejes (se pkt.
English: Move the safety shield away from the needle and toward the syringe barrel.
Danish: Flyt sikkerhedskappen væk fra kanylen og hen imod injektionssprøjtens cylinder.
English: What you need to know before you use Biopoin Do NOT use Biopoin
Danish: Det skal du vide, før du begynder at bruge Biopoin Brug IKKE Biopoin:
English: If you are already taking a medicine to reduce your blood pressure, your doctor might increase the dose.
Danish: Hvis du allerede får blodtrykssænkende medicin, kan lægen vælge at øge dosis.
English: In cancer patients with non-myeloid malignancies receiving chemotherapy epoetin theta should be administered by the subcutaneous route only.
Danish: Hos cancerpatienter med nonmyeloid malign sygdom, der får kemoterapi, bør epoetin theta kun indgives subkutant.
English: - Treatment of symptomatic anaemia associated with chronic renal failure in adult patients.
Danish: - Behandling af symptomatisk anæmi i forbindelse med kronisk nyresvigt hos voksne patienter.
English: During haemodialysis, patients treated with epoetin theta may require increased anticoagulation treatment to prevent clotting of the arterio-venous shunt.
Danish: Under hæmodialyse kan patienter, der får epoetin theta, få behov for øget AK-behandling for at forebygge dannelse af blodpropper i den arteriovenøse shunt.
English: Your doctor will carry out regular blood tests in order to monitor various blood components and their levels.
Danish: Du skal løbende have taget blodprøver til kontrol af blodets sammensætning og mængden af bestanddelene.
English: You can now use the pre-filled syringe.
Danish: Nu kan du bruge den fyldte injektionssprøjte.
English: Information for injecting yourself”).
Danish: Sådan giver du dig selv indsprøjtninger”).
English: Subcutaneous administration: The weekly dose can be given as one injection per week or three times per week.
Danish: Subkutan anvendelse: Den ugentlige dosis kan gives som én ugentlig injektion eller fordeles på tre injektioner om ugen.
English: In the case of injections under the skin, the weekly dose can be given either as 1 injection per week or as 3 divided injections per week.
Danish: Hvis du får indsprøjtningerne i underhuden, kan den ugentlige dosis gives enten som 1 ugentlig indsprøjtning eller fordeles på 3 indsprøjtninger i løbet af ugen.
English: - The other ingredients are sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, hydrochloric acid (6 M) (for pH adjustment) and water for injections.
Danish: - Øvrige indholdsstoffer: Natriumdihydrogenphosphatdihydrat, natriumchlorid, polysorbat 20, trometamol, saltsyre (6 M) (til justering af pH), vand til injektionsvæsker.
English: If someone else is injecting you, they can also use the back and side of your upper arms (see grey areas in picture 7).
Danish: Hvis en anden person giver dig injektionen, kan de også bruge bagsiden og siden af overarmene (se de grå områder på figur 7).
English: For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature (not above 25 °C) or hold the pre-filled syringe gently in your hand for a few minutes.
Danish: Lad den fyldte injektionssprøjte stå i en halv time, så den opnår stuetemperatur (ikke over 25 °C), eller hold den forsigtigt i hånden i nogle få minutter, så injektionen bliver mere behagelig.
English: If the haemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l) a doubling of the weekly dose to 40,000 IU should be considered.
Danish: Hvis hæmoglobinværdien ikke er steget med mindst 1 g/dl (0,62 mmol/l), bør det overvejes at fordoble den ugentlige dosis til 40.000 IE.
English: How to prepare for your injection
Danish: Sådan forbereder du indsprøjtningen