natgillin/translations-raw huggingface dataset:
Hvis du får disse symptomer, når Abseamed injiceres i venen, kan det hjælpe med til at undgå dem, hvis injektionen i fremtiden gives langsommere.
If you have these symptoms during injection into the vein, a slower delivery of the injection may help to avoid them in the future.
Din Abseamed-dosis og hvor ofte, den gives, kan justeres yderligere for at vedligeholde dit respons på behandlingen.
Your Abseamed dose and frequency of administration may be further adjusted to maintain your response to treatment.
Når behandlingen begynder, injiceres Abseamed normalt af en læge eller sygeplejerske.
When treatment starts, Abseamed is usually injected by a medical professional or a nurse.
Abseamed kan nedsætte behovet for blodtransfusion.
Abseamed can reduce the need for a blood transfusion.
Behandling med Abseamed må kun påbegyndes under supervision af en læge med erfaring i behandlingen af patienter, hvor ovenstående indikationer er relevante.
Treatment with Abseamed has to be initiated under the supervision of physicians experienced in the management of patients with the above indications.
Dette afsnit indeholder information om, hvordan du kan give dig selv en indsprøjtning med Abseamed.
This section contains information on how to give yourself an injection of Abseamed.
Hvis du får et andet lægemiddel end Abseamed fra denne gruppe i løbet af din behandling, skal du tale med lægen eller apoteket, før du bruger det.
If you are given a product in this group other than Abseamed during your treatment, speak to your doctor or pharmacist before using it.
• Den normale startdosis af Abseamed til voksne og børn er 50 internationale enheder (IE) pr. kilogram (/kg) kropsvægt, som gives 3 gange om ugen.
• The usual starting dose of Abseamed for adults and children is 50 International Units (IU) per kilogram (/kg) of body weight given three times a week.
Abseamed anvendes til voksne med moderat anæmi, som før en operation donerer noget af deres blod, så det kan gives til dem igen under eller efter operationen.
Abseamed is used in moderately anaemic adults who donate some of their blood before surgery, so that it can be given back to them during or after the operation.
Abseamed kan nedsætte behovet for en blodtransfusion hos disse patienter.
Abseamed can reduce the need for a blood transfusion in these patients.
Hvis du har glemt at tage Abseamed
If you forget to use Abseamed
- hvis væsken er farvet eller du kan se, at der flyder partikler rundt i den, - hvis forseglingen er brudt, - hvis du ved eller tror den utilsigtet har været nedfrosset eller - hvis køleskabet har svigtet.
Abseamed should not be used and discarded - if the liquid is coloured or you can see particles floating in it, - if the seal is broken, - if you know, or think that it may have been accidentally frozen, or - if there has been a refrigerator failure.
Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Abseamed.
Talk to your doctor, pharmacist or nurse before using Abseamed.
• Abseamed gives via indsprøjtning under huden hver uge i tre uger inden operationen og på operationsdagen.
• Abseamed is given by injection under the skin each week for three weeks before surgery and on the day of surgery.
- Patienter, der udvikler pure red cell aplasia (PRCA) efter behandling med erytropoietin, bør ikke få Abseamed eller noget andet erytropoietin-præparat (se pkt.
- Patients who develop pure red cell aplasia (PRCA) following treatment with any erythropoietin should not receive Abseamed or any other erythropoietin (see section 4.4).
• hvis du er blevet diagnosticeret med pure red cell aplasia (knoglemarven kan ikke danne nok røde blodlegemer) efter tidligere behandling med præparater, der stimulerer produktionen af røde blodlegemer (herunder Abseamed).
• if you have been diagnosed with Pure Red Cell Aplasia (the bone marrow cannot produce enough red blood cells) after previous treatment with any product that stimulates red blood cell production (including Abseamed).
• Hvis du har et mere udvidet doseringsinterval (længere end én uge) af Abseamed, vil du måske ikke opretholde tilstrækkelige hæmoglobinniveauer, og du kan have behov for en større dosis Abseamed eller hyppigere indgivelse.
• If you are on a more extended dosing interval (greater than once weekly) of Abseamed, you may not maintain adequate haemoglobin levels and you may require an increase in Abseamed dose or frequency of administration.
• Hvis du ikke responderer tilstrækkeligt på Abseamed, vil din læge kontrollere din dosis og fortælle dig, hvis din Abseamed-dosis skal ændres.
• If you do not respond adequately to Abseamed, your doctor will check your dose and will inform you if you need to change doses of Abseamed.
• Abseamed gives via indsprøjtning i en vene, lige efter du har fået tappet blod i 3 uger før operationen.
• Abseamed is given by injection into a vein immediately after you have donated blood for 3 weeks before your surgery.
• Din læge vil rekvirere blodprøver og kan justere dosis, afhængig af, hvordan din anæmi påvirkes af behandlingen med Abseamed.
• Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Abseamed treatment.
Abseamed kan gives som en indsprøjtning:
Abseamed may be given by injection:
Abseamed leveres med eller uden kanylebeskyttelse, og lægen eller sundhedspersonalet viser dig, hvordan du anvender den.
Abseamed is provided with or without a needle safety guard and you will be shown how to use this by your doctor or nurse.
Fortæl det straks til lægen eller sundhedspersonalet, hvis du bliver opmærksom på nogle af disse bivirkninger, eller hvis du bemærker andre bivirkninger, mens du får behandling med Abseamed.
Tell your doctor or nurse immediately if you are aware of any of these effects, or if you notice any other effects while you are receiving treatment with Abseamed.
Nogle personer, afhængig af hvorfor de behøver behandling med Abseamed, kan senere lære at indsprøjte sig selv under huden: se ”Instruktion i,
Some people, depending on why they need Abseamed treatment, may later learn how to inject themselves under the skin: see Instructions on how to inject Abseamed yourself at the end of the leaflet.
Din læge vil bestemme, hvordan Abseamed skal indsprøjtes.
Your doctor will decide how Abseamed will be injected.
Abseamed og andre præparater, der stimulerer dannelsen af røde blodlegemer, kan øge risikoen for at udvikle blodpropper hos alle patienter.
Abseamed and other products that stimulate red cell production may increase the risk of developing blood clots in all patients.
Abseamed er et sterilt præparat uden konserveringsmiddel og er kun til engangsbrug.
Abseamed is a sterile but unpreserved product and is for single use only.
Vær særligt forsigtig med Abseamed:
Take special care with Abseamed:
Det er muligt, at du stadig kan bruge Abseamed, men du skal først tale med lægen om det:
You may still be able to use Abseamed, but discuss it with your doctor first:
Abseamed ordineres for at stimulere din knoglemarv til at danne flere røde blodlegemer.
Abseamed is prescribed to stimulate your bone marrow to produce more red blood cells.
Hvis du tager på hospitalet, en klinik eller til en praktiserende læge, skal du fortælle dem, at du får behandling med Abseamed.
If you visit a hospital, clinic or family doctor, tell them you are having Abseamed treatment.
Hvis du udvikler et alvorligt udslæt eller får andre af disse hudsymptomer, skal du stoppe med at tage Abseamed og straks kontakte din læge eller søge lægehjælp
If you develop a serious rash or another of these skin symptoms, stop taking Abseamed and contact your doctor or seek medical attention immediately.
Det kan være, at det stadig er muligt at bruge Abseamed, men du skal først tale med lægen om det.
You may still be able to use Abseamed, but discuss it with your doctor first.
Brug af Abseamed hos patienter, der er planlagt til større elektiv ortopædkirurgi, og som ikke deltager i en autolog prædonation af blod, er kontraindiceret, hvis patienten lider af en alvorlig koronar, perifer arteriel, karotid eller cerebrovaskulær lidelse, herunder for nyligt har fået konstateret myokardieinfarkt eller hjerneblødning.
The use of Abseamed in patients scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation programme is contraindicated in patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.
• Brug altid Abseamed nøjagtigt efter lægens eller sundhedspersonalet anvisning.
• Always use Abseamed exactly as instructed by your doctor or nurse.
Det skal du vide, før du begynder at tage Abseamed
What you need to know before you use Abseamed
• Du kan få jerntilskud før og under behandlingen med Abseamed for at gøre det mere effektivt.
• You may be given iron supplements before and during Abseamed treatment to make it more effective.
Hvis intravenøs adgang ikke er umiddelbart tilgængelig (patienter, som endnu ikke er i dialyse, og peritonealdialysepatienter), kan Abseamed administreres som subkutan injektion.
Where intravenous access is not readily available (patients not yet undergoing dialysis and peritoneal dialysis patients) Abseamed may be administered as a subcutaneous injection.
Alternativt kan Abseamed gives med en initialdosis på 450 IE/kg subkutant én gang ugentligt.
Alternatively, Abseamed can be administered at an initial dose of 450 IU/kg subcutaneously once weekly.
Patienter med let anæmi (hæmatokrit på 33 til 39%), som forud skal deponere ≥ 4 enheder blod, skal behandles med Abseamed 600 IE/kg intravenøst 2 gange ugentligt i 3 uger før operationen.
Mildly anaemic patients (haematocrit of 33 to 39%) requiring predeposit of ≥ 4 units of blood should be treated with Abseamed 600 IU/kg intravenously, 2 times per week for 3 weeks prior to surgery.
Der skal udvises forsigtighed, når Abseamed-dosis øges hos patienter med kronisk nyreinsufficiens, da høje kumulative epoetindoser kan være forbundet med en øget risiko for mortalitet samt alvorlige kardiovaskulære og cerebrovaskulære hændelser.
Caution should be exercised with escalation of Abseamed doses in patients with chronic renal failure since high cumulative epoetin doses may be associated with an increased risk of mortality, serious cardiovascular and cerebrovascular events.
Den anbefalede startdosis er Abseamed 450 IE/kg (maksimal samlet dosis er 40.000 IE) administreret subkutant én gang om ugen og med mindst 5 dage mellem hver dosis.
The recommended starting dose is Abseamed 450 IU/kg (maximum total dose is 40,000 IU) administered subcutaneously once every week, with not less than 5 days between doses.
Abseamed bruges til at behandle symptomatisk anæmi forårsaget af nyresygdom:
Abseamed is used to treat symptomatic anaemia caused by kidney disease:
Brug af anden medicin sammen med Abseamed
Other medicines and Abseamed
Den anbefalede Abseamed-dosis er 600 IE/kg subkutant ugentligt i 3 uger (på dag - 21, - 14 og - 7) forud for operationsdagen samt på selve operationsdagen (dag 0).
The recommended dose is Abseamed 600 IU/kg, administered subcutaneously weekly for three weeks (days -21, -14 and -7) prior to surgery and on the day of surgery (day 0).
Abseamed skal administreres intravenøst.
Abseamed should be administered by the intravenous route.
Abseamed anvendes til at behandle anæmi hos voksne med en knoglemarvssygdom, der medfører svære forstyrrelser i dannelsen af blodlegemer (myelodysplastiske syndromer).
Abseamed is used to treat anaemia in adults with a bone marrow disorder that causes a severe disruption in the creation of blood cells (myelodysplastic syndromes).
Abseamed er indiceret hos voksne uden jernmangel forud for større elektive ortopædkirurgiske operationer, der indebærer en risiko for transfusionskomplikationer, til at nedsætte brugen af allogene blodtransfusioner.
Abseamed is indicated for non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions.
Tag kun en dosis af Abseamed fra hver sprøjte.
Only take one dose of Abseamed from each syringe.
Patienter skal monitoreres nøje for at sikre, at der anvendes den laveste godkendte effektive dosis Abseamed til at opnå tilstrækkelig kontrol med anæmi og af anæmisymptomerne under opretholdelse af en hæmoglobinkoncentration under eller på 12 g/dl (7,5 mmol/l).
Patients should be monitored closely to ensure that the lowest approved effective dose of Abseamed is used to provide adequate control of anaemia and of the symptoms of anaemia whilst maintaining a haemoglobin concentration below or at 12 g/dL (7.5 mmol/L).
Abseamed er indiceret hos voksne, der er i behandling med kemoterapi for alvorlige tumorer, malignt lymfom eller myelomatose samt ved risiko ved transfusion pga. patientens almentilstand (f.eks. dennes kardiovaskulære status eller allerede eksisterende anæmi ved start af kemoterapi) til behandling af anæmi og til nedsættelse af transfusionsbehovet.
Abseamed is indicated in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy) for the treatment of anaemia and reduction of transfusion requirements.
(subkutant).
(subcutaneously) yourself.
Abseamed er ikke godkendt til behandling af anæmi forbundet med hepatitis C.
Abseamed is not approved in the management of anaemia associated with hepatitis C.
Vejledninger i, hvordan du selv skal indsprøjte Abseamed
Instructions on how to inject Abseamed yourself
Abseamed anvendes til voksne med moderat anæmi, som skal have foretaget en større ortopædkirurgisk operation (for eksempel udskiftning af hofte eller knæ), for at nedsætte det eventuelle behov for blodtransfusioner.
Abseamed is used in moderately anaemic adults about to have major orthopaedic surgery (for example hip or knee replacement operations), to reduce the potential need for blood transfusions.
Hvis hæmoglobinværdien når 15 g/dl (9,38 mmol/l) eller derover i løbet af den præoperative periode, skal indgiften af Abseamed stoppes og yderligere doser ikke administreres.
If the haemoglobin level reaches 15 g/dL (9.38 mmol/L), or higher, during the preoperative period, administration of Abseamed should be stopped and further dosages should not be administered.
Abseamed anvendes til at behandle anæmi hos voksne, som får kemoterapi for solide svulster, ondartet lymfom eller myelomatose (knoglemarvskræft), og som kan have et behov for en blodtransfusion.
Abseamed is used to treat anaemia in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma (bone marrow cancer) who may have a need for a blood transfusion.
Tal med lægen om det. Nogle personer har behov for medicin for at reducere risikoen for blodpropper, mens de tager Abseamed.
While on Abseamed, some people need medicines to reduce the risk of blood clots.
Abseamed bør administreres for at øge hæmoglobin til ikke over 11 g/dl (6,8 mmol/l).
Abseamed should be administered in order to increase haemoglobin to not greater than 11 g/dL (6.8 mmol/L).
Patienterne skal monitoreres nøje for at sikre, at der anvendes den laveste godkendte Abseamed-dosis til at opnå tilstrækkelig kontrol med anæmi og symptomerne på anæmi.
Patients should be monitored closely to ensure that the lowest approved dose of Abseamed is used to provide adequate control of anaemia and of the symptoms of anaemia.
I tilfælde, hvor der er en klinisk årsag til at afkorte behandlingstiden før operationen til mindre end tre uger, skal Abseamed 300 IE/kg administreres subkutant dagligt i 10 dage før operationen, på selve operationsdagen samt i de 4 første dage umiddelbart efter operationen.
In cases where there is a medical need to shorten the lead time before surgery to less than three weeks, Abseamed 300 IU/kg should be administered subcutaneously daily for 10 consecutive days prior to surgery, on the day of surgery and for four days immediately thereafter.
Hvis du har kronisk nyreinsufficiens, og især hvis du ikke reagerer korrekt på Abseamed, vil din læge kontrollere din Abseamed-dosis, da du har større risiko for at få et problem med hjertet eller blodkarrene, hvis din Abseamed-dosis skal øges gentagne gange, fordi du ikke reagerer på behandlingen.
If you are a patient with chronic renal failure, and particularly if you do not respond properly to Abseamed, your doctor will check your dose of Abseamed because repeatedly increasing your dose of Abseamed 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.
Tag kun en dosis fra hver sprøjte, og fjern den overflødige mængde opløsning før injektion.
Only take one dose of Abseamed from each syringe discarding unwanted solution before injection.
”Instruktion i, hvordan du giver dig selv en indsprøjtning med Abseamed” kan ses sidst i indlægssedlen.
“Instructions on how to inject Abseamed yourself” can be found at the end of the package leaflet.
Tag ikke Abseamed:
Do not use Abseamed:
Abseamed skal administreres subkutant.
Abseamed should be administered as a subcutaneous injection.
Abseamed er en klar, farveløs injektionsvæske, opløsning.
Abseamed is presented as a clear, colourless solution for injection in a pre-filled syringe.
Hos patienter med et dårligt hæmoglobinrespons på Abseamed skal alternative forklaringer på det dårlige respons (se pkt.
In patients with a poor haemoglobin response to Abseamed, alternative explanations for the poor response should be considered (see section 4.4 and 5.1).
hos voksne med primære myelodysplastiske syndromer (MDS) med lav eller intermediær risiko 1, som har lavt serum-erythropoietin (< 200 mE/ml).
Abseamed is indicated for the treatment of symptomatic anaemia (haemoglobin concentration of ≤ 10 g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (< 200 mU/mL).
• Før brug skal kanylen med Abseamed nå stuetemperatur.
• Before use, leave the Abseamed syringe to stand until it reaches room temperature.
Der skal udvises forsigtighed, når Abseamed-dosis øges hos patienter med kronisk nyreinsufficiens.
Caution should be exercised with escalation of Abseamed doses in patients with chronic renal failure.
Indsprøjt Abseamed opløsningen efter lægens anvisning.
Inject the Abseamed solution as you have been shown by your doctor.
Abseamed er indiceret til behandling af symptomatisk anæmi i forbindelse med kronisk nyreinsufficiens (CRF)
Abseamed is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF):
Sådan skal du tage Abseamed
How to use Abseamed
• Du må gerne tage Abseamed ud af køleskabet og opbevare det ved rumtemperatur (op til
• You may take Abseamed out of the refrigerator and keep it at room temperature (up to 25°C) for no longer than 3 days.
Abseamed bør administreres for at øge hæmoglobin til ikke over 12 g/dl (7,5 mmol/l).
Abseamed should be administered in order to increase haemoglobin to not greater than 12 g/dL (7.5 mmol/L).
Abseamed indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, det vil sige, den er i det væsentlige natriumfri.
Abseamed contains less than 1 mmol sodium (23 mg) per dose that is to say essentially “sodium free”.
Abseamed bør administreres til patienter med symptomatisk anæmi (f.eks. hæmoglobinkoncentration ≤ 10 g/dl (6,2 mmol/l)).
Abseamed should be administered to patients with symptomatic anaemia (e.g. haemoglobin concentration ≤ 10 g/dL (6.2 mmol/L)).
Der må kun udtages én dosis Abseamed fra hver injektionssprøjte.
Only one dose of Abseamed from each syringe should be taken.
Hvis hæmoglobin stiger over 2 g/dl (1,25 mmol/l) pr. måned, eller hvis hæmoglobin vedvarende overstiger 12 g/dl (7,5 mmol/l), reduceres Abseamed-dosis med 25%.
If the haemoglobin is rising by more than 2 g/dL (1.25 mmol/L) per month, or if the sustained haemoglobin exceeds 12 g/dL (7.5 mmol/L) reduce the Abseamed dose by 25%.
Abseamed tilhører en gruppe lægemidler, som stimulerer produktionen af røde blodlegemer, ligesom det humane protein erytropoietin gør det. Din læge og sundhedspersonalet vil altid notere præcist det lægemiddel, du får.
Abseamed is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does.
Abseamed skal indgives til patienter med anæmi (f.eks. hæmoglobinkoncentration ≤ 10 g/dl (6,2 mmol/l)).
Abseamed should be administered to patients with anaemia (e.g. haemoglobin concentration ≤ 10 g/dL (6.2 mmol/L)).
Hvis hæmoglobinkoncentrationen stiger med mere end 2 g/dl (1,25 mmol/l) pr. måned, eller hvis hæmoglobinkoncentrationen overstiger 12 g/dl (7,5 mmol/l), skal Abseamed-dosis reduceres med ca.
If the haemoglobin concentration is increasing by more than 2 g/dL (1.25 mmol/L) per month, or if the haemoglobin concentration level exceeds 12 g/dL (7.5 mmol/L), reduce the Abseamed dose by about 25 to 50%.
Hvis hæmoglobin overstiger 13 g/dl (8,1 mmol/l), skal behandlingen seponeres, indtil niveauet falder til under 12 g/dl (7,5 mmol/l), hvorefter behandling med Abseamed genstartes ved en dosis, der er 25% under den tidligere dosis.
If the haemoglobin exceeds 13 g/dL (8.1 mmol/L), discontinue therapy until it falls below 12 g/dL (7.5 mmol/L) and then reinstitute Abseamed therapy at a dose 25% below the previous dose.
Hvis hæmoglobinkoncentrationen overstiger 13 g/dl (8,1 mmol/l), skal behandlingen afbrydes, til det falder til under 12 g/dl (7,5 mmol/l), og derefter genoptages med en Abseamed-dosis, som ligger 25% under den tidligere dosis.
If the haemoglobin concentration level exceeds 13 g/dL (8.1 mmol/L), discontinue therapy until it falls below 12 g/dL (7.5 mmol/L) and then reinitiate Abseamed therapy at a dose 25% below the previous dose.
Du kan finde en vejledning om, hvordan du giver dig selv en injektion af Abseamed sidst i denne indlægsseddel.
Instructions on how to inject yourself with Abseamed can be found at the end of this leaflet.
INFORMATION I BRAILLESKRIFT Abseamed 8.000 IE/0,8 ml
INFORMATION IN BRAILLE Abseamed 8,000 IU/0.8 mL
INFORMATION I BRAILLESKRIFT Abseamed 30.000 IE/0,75 ml
INFORMATION IN BRAILLE Abseamed 30,000 IU/0.75 mL
INFORMATION I BRAILLESKRIFT Abseamed 9.000 IE/0,9 ml
INFORMATION IN BRAILLE Abseamed 9,000 IU/0.9 mL
Abseamed indeholder det aktive stof epoetin alfa, et protein som stimulerer knoglemarven til at danne flere røde blodlegemer, der bærer hæmoglobin (et stof, der transporterer oxygen).
What is in this leaflet What Abseamed is and what it is used for What you need to know before you use Abseamed How to use Abseamed Possible side effects How to store Abseamed Contents of the pack and other information What Abseamed is and what it is used for Abseamed contains the active substance epoetin alfa, a protein that stimulates the bone marrow to produce more red blood cells which carry haemoglobin (a substance that transports oxygen).
Abseamed må ikke administreres som intravenøs infusion eller sammen med andre injektionsvæsker, der indeholder et lægemiddel (se pkt.
Do not administer Abseamed by intravenous infusion or in conjunction with other medicinal product solutions (please refer to section 6.6 for further information).
Hos pædiatriske patienter med kronisk nyreinsufficiens, hvor intravenøs adgang normalt er tilgængelig (hæmodialysepatienter), er intravenøs administration af Abseamed at foretrække.
In paediatric patients with chronic renal failure where intravenous access is routinely available (haemodialysis patients) administration of Abseamed by the intravenous route is preferable.
Hos patienter med kronisk nyreinsufficiens, hvor intravenøs adgang normalt er tilgængelig (hæmodialysepatienter), er intravenøs administration af Abseamed at foretrække.
In patients with chronic renal failure where intravenous access is routinely available (haemodialysis patients) administration of Abseamed by the intravenous route is preferable.
INFORMATION I BRAILLESKRIFT Abseamed 7.000 IE/0,7 ml
INFORMATION IN BRAILLE Abseamed 7,000 IU/0.7 mL