natgillin/translations-raw huggingface dataset:
Hvert hætteglas indeholder 100 mg paclitaxel. • Efter rekonstituering indeholder hver ml suspension 5 mg paclitaxel. • Det andet indholdsstof er menneskealbumin (indeholder natrium, natriumcaprylat og N- acetyl DL tryptofanat).
Each vial contains 100 mg of paclitaxel. • After reconstitution, each ml of suspension contains 5 mg of paclitaxel. • The other ingredient is human albumin (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Abraxanes udseende og pakningsstørrelse
What Abraxane looks like and contents of the pack
Abraxane er et hvidt til gult pulver til tilførsel via suspension, som kan fås i hætteglas, der indeholder 100 mg paclitaxel.
Abraxane is a white to yellow powder for suspension for infusion available in glass vials containing 100 mg paclitaxel.
Indehaveren af markedsføringstilladelsen og fremstiller Abraxis BioScience Limited West Forest Gate Wellington Road Wokingham Berkshire RG40 2AQ Storbritannien
Marketing Authorisation Holder Abraxis BioScience Limited West Forest Gate Wellington Road Wokingham Berkshire RG40 2AQ United Kingdom
Fabrikant Catalent UK Packaging Ltd Lancaster Way Wingates Industrial Park Westhoughton BL5 3XX Storbritannien
Manufacturer Catalent UK Packaging Ltd Lancaster Way Wingates Industrial Park Westhoughton BL5 3XX United Kingdom
Denne indlægsseddel blev senest godkendt {MM/ ÅÅÅÅ}
This leaflet was last approved in {MM/YYYY}
Forsigtighedsregler ved klargøring og indgift
Preparation and administration precautions
24 Paclitaxel er et cytotoksisk, anticancer lægemiddel og, som ved andre potentielt toksiske forbindelser, bør der udvises forsigtighed ved håndtering af Abraxane.
23 Paclitaxel is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Abraxane.
Hvis Abraxanopløsningen kommer i kontakt med huden, skal du straks vaske huden grundigt med vand og sæbe.
If Abraxane suspension contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Rekonstituering af produktet og administration
Reconstitution of the product and administration
Abraxane bør gives under overvågning af en kvalificeret onkolog på afdelinger, der er specialiseret i administration af cytotoksiske midler.
Abraxane should be admin istered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Ved brug af en steril sprøjte injiceres 20 ml natriumklorid 9 mg/ ml (0, 9%) opløsning til infusion langsomt ind i et hætteglas med Abraxane i mindst et minut.
Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should be injected into a vial of Abraxane over a minimum of 1 minute.
Derefter bør hætteglasset forsigtigt og langsomt hvirvles og/ eller vendes på hovedet i mindst to minutter, indtil alt pulver er helt opløst.
The n, the vial should gently and slowly be swirled and/or inverted for at least 2 minutes until complete resuspension of any powder occurs.
Total gensuspension skal sikres vha. mild opblanding inden brug.
Complete resuspension should be ensured by mild agitation of the vial before use.
Hvis der observeres bundfald, bør den rekonstituerede suspension kasseres.
If precipitates are observed, the reconstituted suspension should be discarded.
Beregn den nøjagtige totale dosisvolumen på 5 mg/ ml suspension, der kræves for patienten.
The exact total dosing volume of 5 mg/ml suspension required for the patient should be calculated and the appropriate amount of reconstituted Abraxane should be injected into an empty, sterile, polyvinyl chloride (PVC) type IV bag.
Srøjt derefter den rigtige mængde rekonstitueret Abraxane ind i en tom, steril, polyvinylklorid (PVC) type IV pose.
The use of specialized DEHP-free solution containers or administration sets is not necessary to prepare or administer Abraxane infusions.
Anvendelsen af specialiserede DEHP- frie opløsningsbeholdere eller administrationssæt er ikke nødvendigt for at klargøre eller administrere Abraxane tilførsler In- line filtre bør ikke anvendes.
In-line filters should not be used.
Parenterale lægemidler bør efterses visuelt for småpartikler og misfarvning forud for administration, når som helst opløsning og beholder giver mulighed for det.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Stabilitet Uåbnede hætteglas med Abraxane er stabile, indtil den dato der er angivet på emballagen, så længe hætteglasset opbevares i den ydre emballage for beskyttelse mod lys.
Stability Unopened vials of Abraxane are stable until the date indicated on the package when the vial is kept in the outer carton in order to protect from light.
Hverken frost eller nedkøling påvirker stabiliteten ved produktet negativt.
Neither freezing nor refrigeration adversely affects the stability of the product.
Stabilitet af den rekonstituerede suspension i hætteglasset Når den først er rekonstitueret, bør suspensionen straks fyldes i en infusionspose.
Stability of the reconstituted suspension in the vial After first reconstitution, the suspension should be filled into an infusion bag immediately.
Imidlertid er kemisk og fysisk stabilitet under brugen blevet påvist i 8 timer ved 2°C - 8°C i den originale emballage og beskyttet mod kraftigt lys.
However, chemical and physical in use stability has been demonstrated for 8 hours at 2°C - 8°C in the original carton, and protected from bright light.
Stabilitet af den rekonstituerede suspension i infusionsposen Efter rekonstitution bør den rekonstituerede suspension i infusionsposen anvendes med det samme.
Stability of the reconstituted suspension in the infusion bag After reconstitution, the reconstituted suspension in the infusion bag should be used immediately.
BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET SOM SKAL IMPLEMENTERES I HVERT MEDLEMSLAND
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET SOM SKAL IMPLEMENTERES I HVERT MEDLEMSLAND
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
• brochure med informationer • produktresumé og indlægsseddel og etikettering • kølebokse til patienterne som er tydeligt mærket med en visuel angivelse af, hvordan produktet skal bruges.
• Educational leaflet • Summary of product characteristics (SPC) and Package Leaflet and Labelling • Cool boxes for patients clearly labelled with a visual aid indicating correct use of product.
Brochuren med informationer bør indeholde følgende nøgleelementer: • information om, at anvendelse af epoetin alfaprodukter kan forårsage immunogenicitet, hvilket i sjældne tilfælde kan føre sygdommen Pure Red Cell Aplasia (PRCA) • information om, at der, som det er tilfældet med andre epoetinprodukter, er øget risiko for immunogenicitet ved kronisk nyresygdom (CKD) ved subkutan (sc) indgivelse. • information om, at der ikke findes tilstrækkelig data om Abseamed til at kunne fastslå størrelse af den øgede risiko for immunogenicitet ved subkutan anvendelse • Subkutan indgivelse frarådes til patienter med CKD • Tab af effekt eller andre symptomer på udvikling af immunogenicitet skal undersøges • Ethvert mistænkt tilfælde af sygdommen Pure Red Cell Aplasia eller udvikling af immunogenicitet skal rapporteres til indehaveren af markedsføringstilladelsen.
The educational leaflet shall contain the following key elements: • That the use of epoetin alfa products can cause immunogenicity which in rare cases may lead to Pure Red Cell Aplasia (PRCA) • That with other epoetin products, the risk of immunogenicity in Chronic Kidney Disease (CKD) is increased with the subcutaneous (sc) route. • There is insufficient data on Abseamed to know the size of any increased immunogenicity risk with sc use • Therefore, the sc route is not recommended for patients with CKD • The loss of efficacy or other symptoms of the development of immunogenicity should be investigated • Any suspected case of Pure Red Cell Aplasia or development of immunogenicity should be reported to the MAH
Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede de gennem - førte undersøgelser og nåede frem til sine anbefalinger om, hvordan lægemidlet skal anvendes.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Hvis du ønsker yderligere oplysninger om din sygdomstilstand eller behandling, kan du læse ind - lægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Hvis du ønsker yderligere oplysninger om baggrunden for CHMP' s anbefalinger, kan du læse den faglige drøftel - se (også en del af denne EPAR).
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Det leveres i fyldte sprøjter, der indeholder mellem 1 000 og 10 000 internationale enheder (IE) af det aktive stof, epoetin alfa.
It is available in pre-filled syringes containing between 1,000 and 10,000 international units (IU) of the active substance, epoetin alfa.
Abseamed er et "biosimilært lægemiddel".
Abseamed is a ‘ biosimilar’ medicine.
Det vil sige, at Abseamed svarer til et biologisk lægemid - del, der allerede er godkendt i EU, og indeholder samme aktive stof (dette kaldes "referencelægemid - let").
This means that Abseamed is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘ reference medicine’).
Referencelægemidlet for Abseamed er Eprex/ Erypo.
The reference medicine for Abseamed is Eprex/ Erypo.
Yderligere oplysninger om biosimilære lægemidler med spørgsmål og svar findes her.
For more information on biosimilar medicines, see the question-and-answer document here.
Abseamed anvendes i følgende situationer: • til behandling af anæmi (for få røde blodlegemer) som giver symptomer hos patienter med kronisk nyresvigt (langvarig, fremadskridende nedsættelse af nyrefunktionen) eller andre nyresygdomme • til behandling af anæmi hos voksne patienter, der får kemoterapi for visse kræftformer, og til at mindske behovet for blodtransfusioner • til at øge mængden af blod, der kan tages hos voksne patienter med moderat anæmi, som skal ope - reres og som inden operationen donerer blod til brug under operationen (autolog blodtransfusion) • til at mindske behovet for blodtransfusioner hos voksne med let anæmi, som skal have foretaget større ortopædkirurgiske indgreb, f. eks. hofteoperationer.
Abseamed is used in the following situations: • to treat anaemia (low red blood cell counts) that is causing symptoms in patients with ‘ chronic renal failure’ (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems; • to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce the need for blood transfusions; • to increase the amount of blood that can be take in adult patients with moderate anaemia who are going to have an operation and donate their own blood before surgery (autologous blood transfusion); • to reduce the need for blood transfusions in adults with mild anaemia who are about to undergo major orthopaedic (bone) surgery, such as hip surgery.
Det anvendes hos patienter med normalt jernindhold i blodet, og hos hvem der vil kunne opstå komplikationer, hvis de får blodtransfusion, medmindre de inden operationen har mulighed for at donere blod til eget brug, og som forventes at miste 900 til 1 800 ml blod.
It is used in patients with normal blood iron levels who could experience complications if they were to receive a blood transfusion, if they do not have the opportunity to donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood.
Behandling med Abseamed skal påbegyndes under opsyn af en læge med erfaring i behandling af de sygdomme, lægemidlet er beregnet til.
Treatment with Abseamed must be started under the supervision of a doctor who has experience in the management of patients with the conditions that the medicine is used for.
Til patienter med nyresygdomme og patienter, som donerer blod til eget brug, skal Abseamed gives ved indsprøjtning i en vene.
For patients with kidney problems and patients who are going to donate their own blood, Abseamed must be injected into a vein.
Til patienter, der er i kemoterapi eller som skal opereres, skal indsprøjtningen gives under huden.
Patients receiving chemotherapy or about to undergo orthopaedic surgery receive it under the skin.
Abseamed kan indsprøjtes under hu - den af patienten eller behandleren, hvis de er behørigt instrueret heri.
Abseamed can be injected under the skin by the patient or their carer if they
For patienter med kronisk nyresvigt eller i kemoterapi, skal hæmoglobinniveauet holdes inden for det anbefalede interval (mellem 10 og 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. have been trained appropriately.
12 gram per deciliter hos voksne og mellem 9, 5 og 11 g/ dl hos børn).
For patients with chronic renal failure or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/ dl in children).
Haemoglobin er det protein, der findes i røde blodlegemer, som transporterer ilt rundt i kroppen.
Haemoglobin is the protein in red blood cells that carries oxygen around the body.
Til disse patienter skal den laveste dosis, der giver tilstrækkelig kontrol med symptomerne, anvendes.
For these patients, the lowest dose that provides adequate control of symptoms should be used.
Der bør gives jerntilskud i hele behandlingsperioden.
The iron levels of all patients should be checked before treatment to make sure that they are not too low, and iron supplements should be used throughout treatment.
Yderligere oplysninger fremgår af indlægssedlen.
For full details, see the Package Leaflet.
Et hormon kaldet erytropoietin stimulerer knoglemarven til at øge produktionen af røde blodlegemer.
A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.
Patienter i kemoterapi og patienter med nyresygdomme kan få anæmi, fordi de mangler erytropoietin, eller fordi kroppen ikke reagerer tilstrækkeligt på det naturligt dannede erytropoietin.
In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
Erytropoietin anvendes desuden inden operationer til at øge antallet af røde blodlegemer og afbøde virkningerne af blodtab.
Erythropoietin is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.
Det aktive stof i Abseamed, epoetin alfa, er en kopi af det menneskelige erytropoietin og har nøjagtigt samme stimulerende virkning på produktionen af røde blodlegemer som det naturlige hormon.
The active substance in Abseamed, epoetin alfa, is a copy of human erythropoietin and works in exactly the same way as the natural hormone to stimulate red blood cell production.
Det produceres af en celle, der har fået indsat et gen (dna), som gør den i stand til at producere epoetin alfa.
The epoetin alfa in Abseamed is produced by ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce epoetin alfa.
Forsøgsmodeller og undersøgelser hos mennesker har vist, at Abseamed er sammenligneligt med refe - rencelægemidlet, Eprex/ Erypo.
Abseamed was studied to show that it is comparable with the reference medicine, Eprex/ Erypo, in experimental models and in humans.
Det blev her givet ved indsprøjtning i en vene.
Abseamed, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems.
Alle pati - enterne havde fået Eprex/ Erypo, givet ved indsprøjtning i en vene, i mindst otte uger, før de enten skiftede til Abseamed eller fortsatte med Eprex/ Erypo.
All of the patients had been taking Eprex/ Erypo injected into a vein for at least eight weeks before they were either switched to Abseamed or remained on Eprex/ Erypo.
Behandlingens virkning blev hovedsagelig bedømt på ændringen i blodets indhold af hæmoglobin (det protein i de røde blodlegemer, der trans - porterer ilt rundt i kroppen) fra undersøgelsens start til vurderingsperioden i uge 25 til 29.
The main measure of effectiveness was the change in the levels of haemoglobin between the start of the study and the evaluation period, between weeks 25 and 29.
Firmaet forelagde desuden resultaterne af en undersøgelse, der sammenlignede virkningen af Absea - med, indgivet ved indsprøjtning under huden, med virkningen af Eprex/ Erypo hos 114 kræftpatienter, der fik kemoterapi.
The company also presented the results of a study comparing the effects of Abseamed injected under the skin with those of Eprex/ Erypo in 114 cancer patients who were receiving chemotherapy.
Abseamed var lige så effektivt som Eprex/ Erypo til at øge antallet af røde blodlegemer og holde det oppe.
Abseamed was as effective as Eprex/ Erypo in increasing and maintaining red blood cell counts.
I undersøgelsen hos patienter med anæmi forårsaget af nyresygdom holdt hæmoglobinindholdet hos de patienter, der skiftede til Abseamed, sig lige så godt som hos dem, der fortsatte på Eprex/ Erypo.
In the study of patients with anaemia caused by kidney problems, patients switching to Abseamed maintained haemoglobin levels to the same extent as those continuing to take Eprex/ Erypo.
Abseamed fik hæmoglobinindholdet til at stige med gennemsnitligt 0, 147 g/ dl fra en startværdi på 11, 7 g/ dl.
On average, the levels of the patients taking Abseamed increased by 0.147 g/ dl from a starting value of 11.7 g/ dl.
Hos de patienter, der fortsatte med Eprex/ Erypo, steg hæmoglobinindholdet til sammenligning gennemsnitligt med 0, 063 g/ dl fra en startværdi på 12, 0 g/ dl.
In comparison, those continuing to take Eprex/ Erypo had an increase of 0.063 g/ dl from a starting value of 12.0 g/ dl.
Undersøgelsen hos patienter i kemoterapi viste, at Abseamed også var lige så effektivt som Eprex/ Erypo, når det blev givet ved indsprøjtning under huden.
The study in patients receiving chemotherapy showed that Abseamed was also as effective as Eprex/ Erypo when it was injected under the skin.
Undertiden kan der herved opstå symptomer på hjernesygdom som pludselig, borende, migrænelignende hovedpine og omtågethed.
The most common side effect with Abseamed is an increase in blood pressure, which can sometimes lead to symptoms of encephalopathy (brain problems) such as sudden, stabbing migraine-like headache and confusion.
Abseamed kan desuden give hududslæt og influenzalignende symptomer.
Abseamed can also lead to skin rash and flu-like symptoms.
Den fuldstændige liste over de indberettede bivirkninger for Abseamed fremgår af indlægssedlen.
For the full list of all side effects reported with Abseamed, see the Package Leaflet.
Abseamed bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for epoetin alfa eller nogen af indholdsstofferne.
Abseamed should not be used in people who may be hypersensitive (allergic) to epoetin alfa or any of the other ingredients.
Det bør desuden ikke anvendes hos følgende grupper: • patienter, der har fået "pure red cell aplasi" (nedsat eller ophørt produktion af røde blodlegemer) efter behandling med erytropoietin af enhver art, • patienter med for højt blodtryk, der ikke er velreguleret • patienter, som skal donere deres eget blod, og som har haft et hjerte - eller slagtilfælde inden for den seneste måned, patienter med angina pectoris (en svær form for brystsmerter) eller patienter, som har risiko for dyb venetrombose (DVT: dannelse af blodpropper i kroppens dybtliggende ve - ner, sædvanligvis i benet) • patienter, der ikke må få blodfortyndende medicin, 2/ 3 • patienter, der skal have foretaget større ortopædkirurgiske indgreb og har svære hjer - te- karproblemer, herunder nyligt hjerteanfald eller slagtilfælde.
It must not be used in the following groups: • patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin; • patients with high blood pressure that is not controlled; • patients who are going to donate their own blood who have had a heart attack or stroke within the last month, who have angina pectoris (a severe type of chest pain) or who are at risk of deep 2/ 3 venous thrombosis (DVT: formation of blood clots in the deep veins of the body, usually in the leg); • patients who cannot receive medicines for the prevention of blood clots; • patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
Til behandling af nyreproblemer anbefales det ikke at give Abseamed ved indsprøjtning under huden, da der mangler yderligere undersøgelser, der skal sikre, at man ikke herved får overfølsomhedsreakti - oner.
Abseamed is not recommended for injection under the skin in the treatment of kidney problems because further studies are needed to make sure that this does not cause allergic reactions.
Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at Abseamed i overensstemmelse med EU- kravene er påvist at have en kvalitet, sikkerhed og virkning, der svarer til Eprex/ Erypo.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Abseamed has been shown to have a comparable quality, safety and efficacy profile to Eprex/ Erypo.
CHMP fandt derfor, at de gavnlige virkninger opvejer de identificerede risici, ligesom det er tilfældet for Eprex/ Erypo.
Therefore, the CHMP’ s view was that, as for Eprex/ Erypo, the benefit outweighs the identified risks.
Hvilke foranstaltninger træffes der for at sikre en risikofri anvendelse af Abseamed?
Which measures are being taken to ensure the safe use of Abseamed?
Det firma, der fremstiller Abseamed, skal udarbejde informationsmateriale til det medicinske persona - le i alle EU- medlemsstater, herunder sikkerhedsinformation om lægemidlet.
The company that makes Abseamed will provide information packs for healthcare workers in all Member States, including information on the safety of the medicine.
De vil være forsynet med illustrationer, der viser, hvordan medici - nen skal bruges.
The company will also provide cool boxes for patients, which will include illustrations showing how the medicine should be used.
Andre oplysninger om Abseamed:
Other information about Abseamed:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Abseamed til Medice Arzneimittel Pütter GmbH & Co KG den 28. august 2007.
The European Commission granted a marketing authorisation valid throughout the EU for Abseamed to Medice Arzneimittel Pütter GmbH & Co KG on 28 August 2007.
Den fuldstændige EPAR om Abseamed findes her.
The full EPAR for Abseamed can be found here.
Dette sammendrag blev sidst ajourført i 12- 2008.
This summary was last updated in 12-2008.
1000 IE /
1000 IU/ 0.5 ml
Injektionsvæske, opløsning i en fyldt injektionssprøjte
Solution for injection in a pre-filled syringe
Subkutan eller intravenøs anvendelse.
Subcutaneous or intravenous use
fyldt sprøjte (glas)
pre-filled syringe (glass)
0, 5 ml (2000 IE/ ml)
0.5 ml (2000 IU/ ml)
2000 IE /
2000 IU/ 1.0 ml
1, 0 ml (2000 IE/ ml)
1.0 ml (2000 IU/ ml)
3000 IE /
3000 IU/ 0.3 ml
0, 3 ml (10000 IE/ ml)
0.3 ml (10000 IU/ ml)
4000 IE /
4000 IU/ 0.4 ml
0, 4 ml (10000 IE/ ml)
0.4 ml (10000 IU/ ml)