natgillin/translations-raw huggingface dataset:
Det kan også anvendes til patienter, som har fået behandling mod ITP, som stadig har milten i behold og ikke er egnet til at gennemgå en operation.
It can also be considered for use in patients who have been treated for ITP who have a spleen and cannot have surgery.
Milten er det organ, som medvirker i den proces, hvor blodpladerne ødelægges.
The spleen is an organ that is involved in the destruction of platelets.
Da antallet af patienter med ITP er lavt, betragtes sygdommen som "sjælden", og Nplate blev udpeget som "lægemiddel til sjældne sygdomme" den 27. maj 2005.
Because the number of patients with ITP is low, the disease is considered ‘ rare’, and Nplate was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 27 May 2005.
Nplate gives én gang om ugen som en injektion under huden.
Nplate is given once a week as an injection under the skin.
Startdosen afhænger af patientens vægt og justeres efterfølgende en gang om ugen for at holde antallet af blodplader på målniveauerne.
The starting dose depends on the patient’ s weight, and is then adjusted every week to maintain platelet counts at target levels.
Behandling med Nplate skal afbrydes efter fire ugers behandling med maksimumdosen af Nplate, hvis antallet af blodplader ikke når op på et tilstrækkeligt niveau til, at risikoen for blødning mindskes.
Treatment with Nplate should be stopped after four weeks of treatment with the maximum dose of Nplate if the platelet count does not reach levels that are high enough to reduce the risk of bleeding.
Nplate skal anvendes med forsigtighed til patienter med lever - eller nyreproblemer, eftersom brug af lægemidlet til denne gruppe endnu ikke er blevet formelt undersøgt.
Nplate should be used with caution in patients who have problems with their liver or kidneys because it has not been formally studied in this group.
I kroppen stimulerer et hormon kaldet "trombopoietin" produktionen af blodplader i knoglemarven.
In the body, a hormone called ‘ thrombopoietin ’ stimulates the production of platelets in the bone marrow.
Romiplostim er et protein, som er blevet "designet" (specielt udviklet), så det kan binde sig til og stimulere de samme receptorer som trombopoietin.
Reproduction is authorised provided the source is acknowledged. attach to and stimulate the same receptors as thrombopoietin.
Ved at efterligne trombopoietins virkemåde stimulerer romiplostim produktionen af blodplader og øger derved antallet af dem.
By mimicking the action of thrombopoietin, romiplostim stimulates the production of platelets, increasing blood platelet counts.
Romiplostim fremstilles ved en metode kaldet "rekombinant DNA- teknologi", hvorved en bakterie får indsat et gen (DNA), som gør den i stand til at producere romiplostim.
Romiplostim is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce romiplostim.
Virkningerne af Nplate blev først testet i forsøgsmodeller, inden de blev undersøgt i mennesker.
The effects of Nplate were first tested in experimental models before being studied in humans.
Nplate blev sammenlignet med placebo (en virkningsløs behandling) i to hovedundersøgelser med voksne patienter med kronisk ITP.
Nplate has been compared with placebo (a dummy treatment) in two main studies involving adults with long-term ITP.
I begge undersøgelserne var det primære mål for virkningen antallet af patienter med vedvarende respons på behandlingen, defineret ved, at antallet af blodplader var over 50 mio. pr. ml i mindst seks af de sidste 8 uger af 24- ugersbehandlingen, og uden at der var behov for yderligere lægemidler mod ITP.
This was classified as the patient ’ s platelet counts being above 50 million per millilitre for at least six of the last eight weeks of the 24-week treatment period, without the need for any other medicines for ITP.
Det normale antal er mellem 150 og 400 mio. pr. ml.
Platelet counts below 30 million per millilitre are considered to put ITP patients at risk of bleeding, while normal counts are between 150 and 400 million per millilitre.
I undersøgelsen med patienter, som havde fået fjernet milten, viste 38% af patienterne vedvarende respons på behandling med Nplate (16 ud af 42), sammenlignet med ingen af de 21 patienter, som fik placebo.
In the study of patients whose spleen had been removed, 38% of the patients had a lasting response to treatment with Nplate (16 out of 42), compared with none of the 21 patients receiving placebo.
I undersøgelsen med patienter, som ikke havde fået fjernet milten, viste 61% af patienterne vedvarende respons på behandlingen med Nplate (25 ud af 41), sammenlignet med 5% af de patienter, som fik placebo (1 ud af 21).
In the study of patients with a spleen, 61% of the patients had a lasting response to treatment with Nplate (25 out of 41), compared with 5% of the patients receiving placebo (1 out of 21).
Hvilke risici er der forbundet med Nplate?
What is the risk associated with Nplate?
Den mest almindelige bivirkning ved Nplate (der ses hos mere end 1 ud af 10 patienter) er hovedpine.
The most common side effect with Nplate (seen in more than 1 patient in 10) is headache.
Den fuldstændige liste over alle de indberettede bivirkninger ved Nplate fremgår af indlægssedlen.
For the full list of all side effects reported with Nplate, see the Package Leaflet.
Nplate bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for romiplostim, andre af indholdsstofferne eller proteiner, der produceres af bakterien Escherichia coli.
Nplate should not be used in people who may be hypersensitive (allergic) to romiplostim, any of the other ingredients, or proteins produced by Escherichia coli (a bacterium).
Udvalget for Humanmedicinske Lægemidler (CHMP) noterede sig, at virkningen af Nplate var blevet påvist hos patienter, som havde fået fjernet milten, og hos patienter, som stadig havde milten i behold.
The Committee for Medicinal Products for Human Use (CHMP) noted that the effectiveness of Nplate had been shown in patients whose spleens had been removed, as well as in patients who still had their spleens.
Da fjernelse af milten potentielt kan helbrede ITP, konkluderede udvalget dog, at Nplate kun må anvendes til de patienter, som har milten i behold, hvis disse ikke er egnet til at gennemgå en operation.
However, because removal of the spleen is a potential cure for ITP, the Committee concluded that Nplate should only be used in these patients with a spleen if they are not able to undergo surgery.
CHMP konkluderede derfor, at fordelene ved Nplate er større end risiciene til behandling af voksne med kronisk immun (idiopatisk) trombocytopenisk purpura, som har fået fjernet milten, og som er resistente over for andre behandlinger, og at Nplate kan betragtes som andetvalgsbehandling til voksne patienter med milten i behold, som ikke er egnet til at gennemgå en operation.
Therefore, the CHMP decided that Nplate’ s benefits are greater than its risks for adult chronic immune (idiopathic) thrombocytopenic purpura splenectomised patients who are refractory to other treatments, and that it may be considered as second-line treatment for adult non-splenectomised patients where surgery is contra-indicated.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Nplate.
The Committee recommended that Nplate be given marketing authorisation.
Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Nplate?
Which measures are being taken to ensure the safe use of Nplate?
Virksomheden, der fremstiller Nplate, sørger for, at der udleveres informationsmateriale til læger i hver enkelt medlemsstat.
The company that makes Nplate will provide educational packs for doctors in each Member State.
Materialet vil indeholde oplysninger om Nplates sikkerhed og virkning.
The packs will include information on the safety and effectiveness of Nplate.
Det vil desuden indeholde påmindelser til lægerne om, hvordan lægemidlet skal anvendes, og om at fordelene og risiciene ved Nplate skal drøftes med patienterne.
They will also remind doctors how to use the medicine and to discuss the benefits and risks of Nplate with patients.
Lægerne vil også modtage en "dosisberegner", som gør det lettere for dem at beregne, hvor meget Nplate der skal injiceres.
Doctors will also receive a ‘ dosing calculator’ to help them calculate the volumes of Nplate that need to be injected.
Disse mængder kan nogle gange være meget små.
These volumes can sometimes be very small.
Andre oplysninger om Nplate:
Other information about Nplate:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nplate til Amgen Europe B. V. den 04. februar 2009.
The European Commission granted a marketing authorisation valid throughout the European Union for Nplate to Amgen Europe B. V. on 04 February 2009.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Nplate findes her.
The summary of opinion of the Committee for Orphan Medicinal Products for Nplate is available here.
2/ 3 Den fuldstændige EPAR for Nplate findes her.
The full EPAR for Nplate can be found here.
EU- nummer
EMEA Number
Efter rekonstitution indeholder et volumen på 0, 5 ml opløsning, som er klar til injektion, 250 µg romiplostim (500 µg/ ml).
After reconstitution, a deliverable volume of 0.5 ml solution contains 250 µg of romiplostim (500 µg/ ml).
Romiplostim fremstilles ved hjælp af rekombinant DNA- teknologi i Escherichia coli (E. coli).
Romiplostim is produced by recombinant DNA technology in Escherichia coli (E. coli).
Dette pulver er hvidt.
This powder is white.
Nplate er indiceret til voksne splenektomerede patienter med kronisk immun (idiopatisk) trombocytopenisk purpura (ITP), som er refraktære over for andre behandlinger (fx kortikosteroider, immunglobuliner).
Nplate is indicated for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e. g. corticosteroids, immunoglobulins).
Nplate kan overvejes som andenvalgs- behandling til voksne ikke- splenektomerede patienter, hvis kirurgisk indgreb er kontraindiceret.
Nplate may be considered as second line treatment for adult non-splenectomised patients where surgery is contra-indicated.
Behandling skal foretages under opsyn af en læge med erfaring i behandling af hæmatologiske sygdomme.
Treatment should remain under the supervision of a physician who is experienced in the treatment of haematological diseases.
Begyndelsesdosis
Initial dose
Begyndelsesdosen for romiplostim er 1 µg/ kg baseret på aktuel legemsvægt.
The initial dose of romiplostim is 1 µg/ kg based on actual body weight.
Begyndelses - eller efterfølgende ugentlig dosis:
Weight* in kg x Dose in µg/ kg = Individual patient dose in µg
Vægt * i kg x dosis i µg/ kg = Individuel patientdosis i µg Dosis i µg x 1 ml = Mængde, som skal injiceres, i ml 500 µg
Dose in µg x 1 ml 500 µg = Amount to inject in ml
2 Eksempel:
Example:
En patient på 75 kg begynder med en dosis på 1 µg/ kg romiplostim.
75 kg patient is initiated at 1 µg/ kg of romiplostim.
Patientens individuelle dosis = 75 kg x 1 µg = 75 µg Det tilsvarende volumen Nplate- opløsning, som skal injiceres = 75 µg x 1 ml = 0, 15 ml 500 µg
The individual patient dose = 75 kg x 1 µg = 75 µg The corresponding amount of Nplate solution to inject = 75 µg x 1 ml = 0.15 ml 500 µg
* Anvend altid den aktuelle legemsvægt ved behandlingsstart ved beregning af romiplostim- dosis.
2 *Actual body weight at initiation of treatment should always be used when calculating dose of romiplostim.
Justeringer af dosis baseres derefter udelukkende på ændringer i trombocyttal og foretages i trin på 1 µg (se tabel nedenfor).
Future dose adjustments are based on changes in platelet counts only and made in 1 µg increments (see Table below).
Patientens aktuelle legemsvægt ved behandlingsstart bruges til beregning af dosis.
A subject’ s actual body weight at initiation of therapy should be used to calculate dose.
Den ugentlige dosis romiplostim øges i trin på 1 μg/ kg, indtil patientens trombocyttal når ≥ 50 x 109/ l.
The once weekly dose of romiplostim should be increased by increments of 1 μ g/ kg until the patient achieves a platelet count ≥ 50 x 109/ l.
Patientens trombocyttal skal kontrolleres ugentligt, indtil det stabiliseres (≥ 50 x 109/ l i mindst 4 uger uden justering af dosis).
Platelet counts should be assessed weekly until a stable platelet count (≥ 50 x 109/ l for at least 4 weeks without dose adjustment) has been achieved.
En maksimal ugentlig dosis på 10 µg/ kg må ikke overskrides.
Do not exceed a maximum once weekly dose of 10 μ g/ kg.
Trombocyttal Handling (x 109/ l) < 50 Dosis én gang ugentligt forøges med 1 μg/ kg > 200 i to uger i Dosis én gang ugentligt reduceres med 1 μg/ kg træk Ingen dosering; trombocyttal kontrolleres fortsat hver uge > 400 Når trombocyttallet er faldet til < 200 x 109/ l genoptages indgivelsen med dosis én gang ugentligt, der er reduceret med 1 μg/ kg
Platelet count Action (x 109/ l )< 50 Increase once weekly dose by 1 μg/kg > 200 for two Decrease once weekly dose by 1 μg/kg consecutive weeks Do not administer, continue to assess the platelet count weekly > 400 After the platelet count has fallen to < 200 x 109/l, resume dosing with once weekly dose reduced by 1 μg/kg
4. 4, Tab af respons på romiplostim).
A loss of response or failure to maintain a platelet response with romiplostim within the recommended dosing range should prompt a search for causative factors (see section 4.4, loss of response to romiplostim).
Nplate injektionsvæske indgives subkutant efter rekonstitution af pulveret.
After reconstitution of the powder, Nplate solution for injection is administered subcutaneously.
Injektionsvolumenet kan være meget lille.
The injection volume may be very small.
Der bør anvendes en sprøjte med inddelinger på 0, 01 ml.
A syringe with graduations of 0.01 ml should be used.
6. 6.
For instructions on reconstitution of Nplate, see section 6.6.
Behandlingen med romiplostim bør seponeres, hvis trombocyttallet ikke stiger til et niveau, der er tilstrækkeligt til at undgå klinisk betydende blødning efter 4 ugers behandling med romiplostim ved den højeste ugentlige dosis på 10 µg/ kg.
Treatment with romiplostim should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after four weeks of romiplostim therapy at the highest weekly dose of 10 μ g/ kg.
Patienterne bør jævnligt undersøges klinisk, og fortsættelse af behandlingen skal fastlægges individuelt af den behandlende læge.
Patients should be clinically evaluated periodically and continuation of treatment should be decided on an individual basis by the treating physician.
4. 4).
The reoccurrence of thrombocytopenia is likely upon discontinuation of treatment (see section 4.4).
5. 1).
No overall differences in safety or efficacy have been observed in patients < 65 and ≥ 65 years of age (see section 5.1).
3 henblik på behandling af ældre patienter, tilrådes det dog at være forsigtig i betragtning af det lille antal ældre patienter, der har været inkluderet i kliniske undersøgelser indtil nu.
Although based on these data no adjustment of the dosing regimen is required for older patients, care is advised considering the small number of elderly patients included in the clinical trials so far.
Børn og unge (< 18 år)
3 Children and adolescents (< 18 years)
Nplate bør ikke anvendes til børn under 18 år pga. utilstrækkelig dokumentation for sikkerhed eller virkning.
Nplate is not recommended for use in children below age 18 due to insufficient data on safety or efficacy.
Der findes ingen dosisanbefalinger til børn og unge.
No dose advice in this population can be provided.
Nedsat lever - og nyrefunktion
Hepatic and renal impairment
Der er ikke udført formelle kliniske undersøgelser for disse patientgrupper.
No formal clinical studies have been conducted in these patient populations.
Overfølsomhed over for det aktive stof, et eller flere af hjælpestofferne eller E. coli- afledte proteiner.
Hypersensitivity to the active substance, to any of the excipients or to E. coli derived proteins.
Følgende særlige advarsler og forsigtighedsregler er baseret på faktiske observationer eller på potentielle virkninger forbundet med de farmakologiske virkningsmekanismer for trombopoietin (TPO) - receptorstimulatorer.
The following special warnings and precautions have been actually observed or are potential class effects based on the pharmacological mechanism of action of thrombopoietin (TPO) receptor stimulators.
Der er en større blødningsrisiko, hvis behandlingen med romiplostim seponeres under brug af koagulations - hæmmende midler eller midler, som hæmmer trombocytfunktioner.
There is an increased risk of bleeding if romiplostim treatment is discontinued in the presence of anticoagulants or anti-platelet agents.
Ved seponering af behandling med romiplostim tilrådes det, at ITP- behandlingen genoptages i henhold til de aktuelle retningslinjer for behandling.
It is recommended that, if treatment with romiplostim is discontinued, ITP treatment be restarted according to current treatment guidelines.
Yderligere medicinsk behandling kan omfatte seponering af koagulationshæmmende og/ eller trombocytfunktionshæmmende behandling, ophævelse af den antikoagulerende virkning, eller støtte af trombocytfunktion.
Additional medical management may include cessation of anticoagulant and/ or antiplatelet therapy, reversal of anticoagulation, or platelet support.
Øget knoglemarvsretikulin menes at være et resultat af stimulering af TPO- receptorerne, hvilket resulterer i et øget antal megakaryocytter i knoglemarven, som efterfølgende kan afgive cytokiner.
Increased bone marrow reticulin is believed to be a result of TPO receptor stimulation, leading to an increased number of megakaryocytes in the bone marrow, which may subsequently release cytokines.
Pkt.
Therefore, examinations for cellular morphological abnormalities using peripheral blood smear and complete blood count (CBC) prior to and during treatment with romiplostim are recommended.
4. 8 indeholder information om stigninger i retikulin, der er observeret i kliniske undersøgelser med romiplostim.
See Section 4.8 for information on the increases of reticulin observed in romiplostim clinical trials.
Hvis der hos patienter ses en reduceret virkning og en abnorm perifer blodudstrygning, skal indgivelsen af romiplostim seponeres, og der skal foretages en helbredsundersøgelse, og en knoglemarvsbiopsi med relevant retikulin- farvning skal overvejes.
If a loss of efficacy and abnormal peripheral blood smear is observed in patients, administration of romiplostim should be discontinued, a physical examination should be performed, and a bone marrow biopsy with appropriate staining for reticulin should be considered.
Endvidere skal lægen på ny vurdere fordele/ ulemper ved behandling med romiplostim og alternative ITP- behandlinger.
If efficacy is maintained and abnormal peripheral blood smear is observed in patients, the physician should follow appropriate clinical judgment, including consideration of a bone marrow biopsy, and the risk-benefit of romiplostim and alternative ITP treatment options should be re-assessed.
Trombotiske/ tromboemboliske komplikationer
Thrombotic/ thromboembolic complications
Trombocyttal over det normale værdiområde udgør en teoretisk risiko for trombotiske / tromboemboliske komplikationer.
Platelet counts above the normal range present a theoretical risk for thrombotic/ thromboembolic complications.
Antallet af trombotiske/ tromboemboliske hændelser, som blev set i kliniske undersøgelser, var ens for romiplostim og placebo, og der sås ikke en forbindelse mellem
The incidence of thrombotic/ thromboembolic events observed in clinical trials was similar between romiplostim and placebo, and an association between these events and elevated platelet counts was not observed.
4. 2).
Dose adjustment guidelines should be followed (see section 4.2).
Progression af eksisterende hæmatopoietiske maligniteter eller myelodysplastiske syndromer (MDS)
4 Progression of existing haematopoietic malignancies or Myelodysplastic Syndromes (MDS)
TPO- receptorstimulatorer er vækstfaktorer, som fører til trombopoietisk progenitorcelle- tilvækst, differentiering og trombocytproduktion.
TPO receptor stimulators are growth factors that lead to thrombopoietic progenitor cell expansion, differentiation, and platelet production.
TPO- receptoren udtrykkes hovedsagligt på overfladen af celler af myeloid afstamning.
The TPO receptor is predominantly expressed on the surface of cells of the myeloid lineage.
TPO- receptorstimulatorer kan i teorien stimulere progression af eksisterende hæmatopoietiske maligniteter eller MDS.
For TPO receptor stimulators there is a theoretical concern that they may stimulate the progression of existing haematopoietic malignancies or MDS.
Romiplostim bør ikke anvendes til behandling af trombocytopeni, der skyldes MDS eller andre årsager end trombocytopeni bortset fra ITP uden for kliniske undersøgelser.
Romiplostim should not be used for the treatment of thrombocytopenia due to MDS or any other cause of thrombocytopenia other than ITP outside of clinical trials.
Risiko - / fordelsprofilen for romiplostim er endnu ikke fastlagt for patienter med MDS eller andre patientpopulationer uden ITP.
The risk-benefit profile for romiplostim has not been established in MDS or other non-ITP patient populations.
I en åben klinisk undersøgelse med en enkelt behandlingsarm med romiplostim til patienter med MDS blev der indberettet tilfælde af progression til akut myeloid leukæmi (AML); dette er dog et forventet klinisk udfald af MDS, og sammenhængen med behandling med romiplostim er ikke tydelig.
In a single-arm, open-label clinical study of treatment with romiplostim in patients with MDS, there were reported cases of progression to acute myeloid leukaemia (AML), however this is an expected clinical outcome of MDS and the relationship to romiplostim treatment is unclear.
Desuden blev der i denne undersøgelse observeret tilfælde af forbigående stigninger i blastceller.
In addition, cases of transient blast cell increases were observed in this study.
De forbigående stigninger i blastceller var reversible efter seponering af romiplostim.
The transient blast cell increases were reversible upon discontinuation of romiplostim.
Denne observation stemmer derfor ikke overens med progression til AML.
Therefore this observation is inconsistent with progression to AML.
Det er ikke muligt at skelne mellem leukæmiske blaster og normale blaster.
It is not possible to distinguish leukaemic blasts from normal blasts.
4. 8) og øget knoglemarvsretikulin (se ovenfor).
A loss of response or failure to maintain a platelet response with romiplostim treatment within the recommended dosing range should prompt a search for causative factors, including immunogenicity (see section 4.8) and increased bone marrow reticulin (see above).
Ændringer i parametrene for røde (et fald) og hvide (en stigning) blodlegemer er observeret i ikke - kliniske toksikologiske undersøgelser (rotter og aber), men ikke hos ITP- patienter.
Alterations in red (decrease) and white (increase) blood cell parameters have been observed in non- clinical toxicology studies (rat and monkey) but not in ITP patients.
Monitorering af disse parametre skal overvejes for patienter, der behandles med romiplostim.
Monitoring of these parameters should be considered in patients treated with romiplostim.
De potentielle interaktioner mellem romiplostim og samtidig anvendte præparater som følge af bindingen til plasmaproteiner kendes endnu ikke.
The potential interactions of romiplostim with co- administered drugs due to binding to plasma proteins remain unknown.
Lægemidler, der er brugt til behandling af ITP i kombination med romiplostim i kliniske undersøgelser, inkluderede kortikosteroider, danazol og/ eller azathioprin, intravenøst immunglobulin (IVIG) og anti- D immunglobulin.
Medicinal products used in the treatment of ITP in combination with romiplostim in clinical studies included corticosteroids, danazol, and/ or azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin.