natgillin/translations-raw huggingface dataset:
Hvis du vil have yderligere oplysninger om Potactasol, skal du henvende dig til den lokale repræsentant:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Tilsat 39 ml giver 40 ml
1 ml of 1 mg/ml topotecan solution Add 39 ml to give 40 ml
Sådan bruges Potactasol
How to use Potactasol
Potactasol 1 mg pulver til koncentrat til infusionsvæske, opløsning Potactasol 4 mg pulver til koncentrat til infusionsvæske, opløsning
Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 4 mg powder for concentrate for solution for infusion
Neutropenisk colitis, herunder letal neutropenisk colitis, er set som en komplikation til topotecaninduceret neutropeni (se pkt.
1 Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4) 2 Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4).
Luftveje, thorax og mediastinum Sjælden:
anorexia (which may be severe) Respiratory, thoracic and mediastinal disorders Rare:
Hud og subkutane væv Meget almindelig: alopeci Almindelig:
hyperbilirubinaemia Skin and subcutaneous tissue disorders Very common:
Potactasol 1 mg pulver til koncentrat til infusionsvæske, opløsning Potactasol 4 mg pulver til koncentrat til infusionsvæske, opløsning topotecan
Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 4 mg powder for concentrate for solution for infusion topotecan
trombocyttallet er ≥ 100 x 109/l og hæmoglobinniveauet er ≥ 9 g/dl (om nødvendigt efter transfusion).
Topotecan should not be re-administered unless the neutrophil count is ≥ 1 x 109/l, the platelet count is ≥ 100 x 109/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary).
anafylaktisk reaktion angioødem urticaria
anaphylactic reaction angioedema urticaria
Potactasol 4 mg pulver til koncentrat til infusionsvæske, opløsning topotecan
Potactasol 4 mg powder for concentrate for solution for infusion topotecan
Potactasol 1 mg pulver til koncentrat til infusionsvæske, opløsning topotecan
Potactasol 1 mg powder for concentrate for solution for infusion topotecan
Disse bivirkninger er dog tidligere set som følge af behandling med cisplatin-monoterapi og skyldes ikke topotecan.
Additional adverse events were seen when topotecan was given in combination with cisplatin, however, these events were seen with cisplatin monotherapy and were not attributable to topotecan.
• patienter med recidiverende småcellet lungecancer (SCLC) for hvem gentagelse af 1. linje behandling ikke anses for hensigtsmæssig (se pkt.
Topotecan monotherapy is indicated for the treatment of: - patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy - patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
Sådan får du Potactasol
How to store Potactasol
Metabolisme og ernæring Meget almindelig: anoreksi (muligvis alvorlig)
Metabolism and nutrition disorders Very common:
Blod og lymfesystem
Blood and lymphatic system disorders Very common:
For patienter (n = 39) med recidiv inden for 180 dage efter kemo/stråleterapi med cisplatin, var medianoverlevelsen i den gruppe, der fik topotecan + cisplatin 4,6 mdr.
In patients (n = 39) with recurrence within 180 days after chemoradiotherapy with cisplatin, the median survival in the topotecan plus cisplatin arm was 4.6 months (95 % CI: 2.6, 6.1) versus 4.5 months (95 % CI: 2.9, 9.6) for the cisplatin arm with a hazard ratio of 1.15 (0.59, 2.23).
Almene symptomer og reaktioner på administrationsstedet Meget almindelig: pyreksi asteni træthed
General disorders and administration site conditions Very common:
1 ml af 1 mg/ml topotecan opløsning
1 x 1 mg vial
Dosering
mucositis
utilpashed
infection
Efter denne periode kan produktet sættes tilbage i køleskabet.
At the end of this period the product can be put back in the refrigerator.
5 Wald konfidensinterval.
5 Wald confidence interval.
Som for alle proteiner er der et potentiale for immunogenicitet.
As with all proteins there is a potential for immunogenicity.
Der skal inkluderes praktisk rådgivning for at nedsætte risikoen.
Practical advice should be included to mitigate the risk.
Hovedparten (90,9 %) af patienterne var kvinder.
The majority (90.9%) of patients were female.
Denne vil lægen beregne.
Your doctor will calculate this.
Se tabel 3.
See Table 3.
På grund af de manglende velkontrollerede studier er der imidlertid fortsat usikkerhed.
However, due to the lack of wellcontrolled studies, uncertainties remain.
Min; Maks
Min, Max
Voksne patienter:
Adult Patients:
Ingen betydelig forskel blev observeret i sikkerhed og virkning i forhold til alderen.
No substantial differences were seen in safety and efficacy related to age.
Sikkerhedsdata fra andre kliniske studier
Safety Data from Other Clinical Studies
Patienterne rapporterede om forbedret helbredsrelateret livskvalitet (QoL).
Patients reported improved health-related quality of life (QoL).
Der er også links til andre websteder om sjældne sygdomme og om,hvordan de behandles.
There are also links to other websites about rare diseases and treatments.
Alle effektendepunkter blev forbedret eller opretholdt gennem 2 års behandling.
All rates of efficacy endpoints improved or were maintained through 2 years of treatment.
• advarsel om straks at søge lægehjælp hvis ovenstående er tilstede.
• Warning to seek immediate medical care if above are present.
Vær opmærksom på, at du skal gå til læge hurtigst muligt, selv om du føler dig bedre efter at have taget antibiotika.
You should bear in mind that you should see a doctor as soon as possible, even if you feel better after having taken the antibiotics.
Vaccination kan forårsage yderligere komplementaktivering.
Vaccination may further activate complement.
Sikkerhedsprofilerne hos de forskellige pædiatriske aldersundergrupper forekommer at være de samme.
The safety profiles in the different paediatric subsets of age appear similar.
Positiv Coombs test c
Coombs test positive c
Efter hver infusion vil du blive overvåget i ca. en time.
Following each infusion, you will be monitored for about one hour.
*Se afsnittet Beskrivelse af udvalgte bivirkninger.
*See paragraph Description of selected adverse reactions.
• kontaktinformationer hvor sundhedspersonale kan modtage yderligere informationer.
• Contact details where a health care practitioner can receive further information.
Afhængigt af nationale retningslinjer kan lægen finde det nødvendigt med supplerende foranstaltninger til at forebygge infektion.
In accordance with national recommendations, your doctor might consider that you need supplementary measures to prevent infection.
p-værdi (fra analyse af gentagne målinger)
p-value (using repeated measures analysis)
Type af plasmaintervention
Type of Plasma Intervention
Patienter med andre sygdomme
Patients with other diseases
Efter 26 uger
At 26-weeks
Det førte også til en markant reduktion af eller ophør med blodtransfusioner og en tendens til en samlet forbedring i den almene funktion.
It also resulted in a marked decrease or elimination of blood transfusions, and a trend towards an overall improvement in general function.
Soliris bør derfor kun anvendes til gravide, hvis der er klart behov for det.
Therefore, Soliris should be given to a pregnant woman only if clearly needed.
Kortet kaldes: ”Patientsikkerhedskort”.
This card is named: “Patient Safety Card”.
Andre systemiske infektioner
Other Systemic Infections
Hvis en sådan behandling anses for at være nødvendig under graviditet, anbefales en nøje overvågning af moder og foster i henhold til lokale retningslinjer.
Should such a treatment be considered necessary during pregnancy, a close maternal and foetal monitoring according to local guidelines is recommended.
Hvis du kommer ud for nogen af ovenstående symptomer, skal du tage antibiotika som foreskrevet.
If you experience any of the symptoms amongst those cited above, you should take the antibiotics as prescribed.
Der bør tages hensyn til officielle retningslinjer for hensigtsmæssig brug af antibiotika.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
1.Ved data-afslutning (20. april 2012)
At data cut off (20 April 2012)
Begge patienter var negative med hensyn til neutraliserende antistoffer.
Both patients were negative for neutralizing antibodies.
I dette regi blev der observeret en reduktion af den daglige dosis på mindst 1 immunsuppressivt middel hos 47 % af patienterne.
In this setting, a decrease of the daily dose of at least 1 immunosuppressant was observed in 47% of patients.
Efter fortynding skal produktet anvendes inden for 24 timer.
After dilution, the product should be used within 24 hours.
• tegn og symptomer på infektion og sepsis.
• Signs and symptoms of infection and sepsis.
1/100 (1 %) aHUS-patienter havde lave positive værdier for neutraliserende antistoffer.
1/100 (1%) aHUS patients had low positive values for neutralizing antibodies.
Kemisk og fysisk stabilitet i indtil 24 timer ved 2 °C til 8 °C er dog påvist.
However, chemical and physical stability has been demonstrated for 24 hours at 2°C - 8°C.
Der foreligger ingen velkontrollerede studier af gravide kvinder behandlet med eculizumab.
There are no well-controlled studies in pregnant women treated with eculizumab.
4 Baseret på en stratificeret Cox-proportional hazards-model.
4 Based on a stratified Cox proportional hazards model.
Patheon Italia S.p.A Viale G. B. Stucchi, 110 20900 Monza (MB) Italien
Patheon Italia S.p.A Viale G. B. Stucchi, 110 20900 Monza (MB) Italy
Derfor bør patienterne monitoreres tæt for sygdomssymptomer efter anbefalet vaccination.
Therefore, patients should be closely monitored for disease symptoms after recommended vaccination.
Anvisninger for korrekt brug
Instructions for proper use
Undgåelse af transfusion under behandlingen (%)
Transfusion Avoidance during treatment (%)
• irritation i øjet
• irritation of eye
Effektresultater for analyser af de præspecificerede gentagne målinger af primære og sekundære endepunkter kan ses i tabel 10.
Efficacy outcomes for the pre-specified repeated measures analyses of the primary and secondary endpoints are provided in Table 10.
Soliris kan anvendes til patienter på 65 år og derover.
Soliris may be administered to patients aged 65 years and over.
Antal patientår i alt i studieperioden n
Total number of patient-years in study period n
Dette resultat blev imidlertid opnået i ikke-kontrollerede kliniske studier.
However, this finding was shown in non-controlled clinical trials.
Medianalderen for den første dosis studielægemiddel var 45 år.
The median age at first dose of study drug was 45 years.
Soliris Ingen transfusion
Soliris No transfusion
Bemærk: Patienter, som ikke oplevede et adjudikeret recidiv i løbet af studiet, blev censureret ved slutningen af studieperioden.
Note: Patients who did not experience an adjudicated On-trial Relapse were censored at the end of the Study Period.
Du skal vide, at vaccination ikke nødvendigvis beskytter mod denne type infektion.
You should also be aware that vaccination may not prevent this type of infection.
Disse studier omfattede en vurdering af fertilitet og tidlig embryonisk udvikling, udviklingstoksicitet og præ- og postnatal udvikling.
These studies included assessment of fertility and early embryonic development, developmental toxicity, and pre and post-natal development.
Historisk annualiseret recidivrate inden for 24 måneder før screening
Historical Annualized Relapse Rate within 24 months prior to Screening
maks)
max)
Efter fortynding skal lægemidlet anvendes straks.
After dilution, the medicinal product should be used immediately.
Berkshire SL1 4DX Storbritannien
Berkshire SL1 4DX United Kingdom
3 Baseret på en stratificeret log-rank-test.
3 Based on a stratified log-rank test.
Refraktær generaliseret myasthenia gravis
Refractory Generalized Myasthenia Gravis
Humane antistoffer nedbrydes hovedsagelig af lysosomale enzymer til små peptider og aminosyrer.
Human antibodies are predominately catabolized by lysosomal enzymes to small peptides and amino acids.
Tabel 11 viser en oversigt over patienter, der rapporterede klinisk forværring, og patienter, der havde behov for nødbehandling, i løbet af de 26 uger.
Table 11 presents an overview of the patients reporting clinical deterioration and patients requiring rescue therapy over the 26 weeks.
2 Baseret på den komplementære log-log-transformation.
2 Based on the complementary log-log transformation.
• detaljer omkring PNH og aHUS registrene og hvordan man indskriver patienter.
• Details of the PNH and aHUS registries and how to enter patients.
Alle patienter, der behandles med eculizumab, modtager et patientsikkerhedskort
All patients being treated with eculizumab receive a patient safety card.
Din læge vil da ønske at holde dig under nøje observation i mindst 8 uger.
Your doctor will want to monitor you closely for at least 8 weeks.
Parret t-test
Paired t-test
Ca. halvdelen var kaukasere (49,0 %).
Approximately half were White (49.0%).
Uddannelsesmaterialet skal aftales med den ansvarlige nationale myndighed og skal indeholde følgende elementer:
The educational material should be agreed with the National Competent Authority and should contain the following:
4- Særlig håndtering og opbevaring
4- Special Handling and Storage
• tegn og symptomer på svær infektion og behovet for at modtage akut lægehjælp.
• Signs and symptoms of severe infection and the need to obtain urgent medical care.
TMAintervention blev defineret som PE/PI-behandling eller ny dialyse.
TMA interventions were defined as PE/PI or new dialysis.
Hvis du ikke helt forstår, hvad nedenstående bivirkninger er, kan du bede lægen forklare dem.
If you are not sure what the side effects below are, ask your doctor to explain them to you.
Steady state opnås efter 4 uger med dosisregimet for PNH hos voksne.
The steady state is achieved by 4 weeks using the PNH adult dosing regimen.
Eculizumabs clearance og halveringstid blev også evalueret ved plasmaudskiftnings-interventioner.
The clearance and half-life of eculizumab were also evaluated during plasma exchange interventions.
Humane antistoffer undergår endocytotisk nedbrydning i cellerne i det retikuloendotelielle system.
Human antibodies undergo endocytotic digestion in the cells of the reticuloendothelial system.
Derfor anbefales en individuel benefit/risk-analyse før og under behandlingen med eculizumab hos gravide kvinder.
Therefore, an individual risk benefit analysis is recommended before starting and during treatment with eculizumab in pregnant women.
Pædiatriske patienter med PNH og aHUS:
Paediatric patients in PNH and aHUS:
• alle patienter skal monitoreres for tegn på meningokokinfektion.
• All patients must be monitored for signs of meningococcal infection.
Plasmaudskiftning resulterede i et fald på ca. 50 % i eculizumabkoncentrationen efter en intervention på 1 time, og eliminationshalveringstiden af eculizumab blev reduceret til 1,3 timer.
Plasma exchange resulted in an approximately 50% decline in eculizumab concentrations following a 1 hour intervention and the elimination half-life of eculizumab was reduced to 1.3 hours.
Malignt melanom, myelodysplastisk syndrom
Malignant melanoma, Myelodysplastic syndrome
Eculizumab indeholder kun naturligt forekommende aminosyrer og har ingen kendte aktive metabolitter.
Eculizumab contains only naturally occurring amino acids and has no known active metabolites.
Lægerne bør rådgive patienterne om, hvordan gonorré undgås.
Physicians should advise patients about gonorrhoea prevention.
Patienterne kan have øget følsomhed for infektioner, især med Neisseria og indkapslede bakterier.
Patients may have increased susceptibility to infections, especially with Neisseria and encapsulated bacteria.
Det anbefales, at din behandling indledes med en startfase på 4 uger, efterfulgt af en vedligeholdelsesfase.
It is recommended that the beginning of your treatments, called the initial phase, will extend over 4 weeks, followed by a maintenance phase.
Indenfor hver frekvensgruppe præsenteres bivirkninger ordnet efter faldende alvorlighed.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Alle patienter, der blev inkluderet i studiet, var patienter med refraktær gMG, som opfyldte de følgende prædefinerede kriterier:
All patients included in the trial were refractory gMG patients and met the following predefined criteria:
På grund af begrænsningerne i de tilgængelige data skal de udviklings- og sundhedsmæssige fordele ved amningen dog afvejes i forhold til moderens kliniske behov for eculizumab og mulige bivirkninger for det ammede barn fra eculizumab eller fra moderens underliggende tilstand.
However, due to the limitations of the available data, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for eculizumab and any potential adverse effects on the breastfed child from eculizumab or from the underlying maternal condition.
I SHEPHERD-studiet fuldførte 96 af de 97 patienter, der indgik i studiet (én patient døde efter en trombotisk hændelse).
In SHEPHERD study, 96 of the 97 enrolled patients completed the study (one patient died following a thrombotic event).
• gulfarvning af huden og/eller øjnene (gulsot)
• yellowing of the skin and/or eyes (jaundice)
Eculizumab bevarer de tidlige komponenter af komplementaktiveringen, der er essentiel for opsonisering af mikroorganismer og elimination af immunkomplekser.
Eculizumab preserves the early components of complement activation that are essential for opsonization of microorganisms and clearance of immune complexes.
Hætteglassene med Soliris i den originale emballage må kun opbevares uden for køleskabet i en enkelt periode på op til 3 dage.
Soliris vials in the original package may be removed from refrigerated storage for only one single period of up to 3 days.
Fremstillingsprocessen for lægemiddelstoffet omfatter desuden specifikke trin til inaktivering og fjernelse af virus.
The bulk drug substance manufacturing process also includes specific viral inactivation and removal steps.
Inkluderede studier: Astma (C07-002), aHUS (C08-002, C08-003, C10-003, C10-004), dermatomyositis (C99006), gMG (C08-001, ECU-MG-301, ECU-MG-302 dataafskæring den 31. dec 2017), neuromyelitis optica spektrumsygdom (ECU-NMO-301), IMG (C99-004, E99-004), PNH (C02-001, C04-001, C04-002, C06-002, C07-001, E02-001, E05-001, E07-001, M07-005, X03-001, X03-001A), psoriasis (C99-007), RA (C01-004, C97-001, C99-001, E01-004, E99-001), STEC-HUS (C11-001), SLE (C97-002).
Included Studies: Asthma (C07-002), aHUS(C08-002, C08-003, C10-003, C10-004), Dermatomyositis (C99-006), gMG (C08-001, ECU-MG-301, ECU-MG-302 data cut as of 31Dec2017), Neuromyelitis Optica Spectrum Disorder (ECU-NMO-301), IMG (C99-004, E99-004), PNH (C02-001, C04-001, C04-002, C06-002, C07-001, E02-001, E05001, E07-001, M07-005, X03-001, X03-001A), Psoriasis (C99-007), RA (C01-004, C97-001, C99-001, E01-004, E99-001), STEC-HUS (C11-001), SLE (C97-002).
På grund af forudgående irreversible nyreskader ændredes nyrefunktionen dog ikke (tabel 16).
However, renal function was not changed due to prior irreversible kidney damage (Table 16).
• indskrivning i PNH og aHUS registrene.
• Enrolment in the PNH and aHUS registries.
Patienten skal vaccineres i henhold til den gældende nationale vaccinationsvejledning.
Patients must receive vaccination according to current national vaccination guidelines for vaccination use.
Farmakoterapeutisk klassifikation: Selektive immunsuppressive midler, ATC-kode: L04AA25
Pharmacotherapeutic group: Selective immunosuppressants, ATC code: L04AA25
Positive ADA-prøver havde lavt titer, som var forbigående.
Positive ADA samples were low titer and transient.
Komplet TMA-respons blev opretholdt hos alle responderende patienter.
Complete TMA response was maintained by all responders.
Sundhedspersonalet bør rådes til at være på udkig efter risikofaktorer og tegn og symptomer på Aspergillus-infektion.
The healthcare professionals should be advised to look for risk factors and signs and symptoms of Aspergillus infection.
DATO FOR ÆNDRING AF TEKSTEN Dato:
DATE OF REVISION OF THE TEXT
Vedligeholdelsesfase
Maintenance Phase
Det bør kun overvejes at afbryde behandlingen, hvis det er medicinsk indiceret.
Discontinuation of treatment should only be considered if medically justified.
• der er en vigtig risiko for Aspergillus-infektion hos patienter i behandling med eculizumab.
• There is an important risk of Aspergillus infection in patients treated with eculizumab.
• Vedligeholdelsesfase:
• Maintenance Phase:
Klar, farveløs opløsning med pH 7,0.
Clear, colorless, pH 7.0 solution.
Intet tyder på, at særlige sikkerhedsregler skulle være nødvendige ved behandling af ældre, men erfaringerne med Soliris til denne patientpopulation er stadig begrænsede.
There is no evidence to suggest that any special precautions are needed when older people are treated - although experience with Soliris in this patient population is still limited.
Andre tilfælde af Neisseria-arter er blevet indberettet, herunder sepsis med Neisseria gonorrhoeae, Neisseria sicca/subflava, Neisseria spp ikke specificeret.
Other cases of Neisseria species have been reported including sepsis with Neisseria gonorrhoeae, Neisseria sicca/subflava, Neisseria spp unspecified.
Hvis du har risiko for gonorré, skal du spørge lægen eller apotekspersonalet til råds, før du bruger dette lægemiddel.
If you are at risk of gonorrhoea, ask your doctor or pharmacist for advice before using this medicine.
1 Baseret på Kaplan-Meier-estimatormetoden.
1 Based on the Kaplan-Meier product limit method.
Sammenlignelige responser blev observeret i alle aldersgrupper fra 5 måneder til 17 år.
Responses were similar across all ages from 5 months to 17 years of age.
De vigtigste baseline-karakteristika blev afbalanceret (se tabel 2).
Major baseline characteristics were balanced (see Table 2).
Baseret på den mulige hæmmende virkning af eculizumab på den komplementafhængige cytotoksicitet af rituximab, kan eculizuab reducere de forventede farmakodyaniske virkninger af rituximab.
Based on the potential inhibitory effect of eculizumab on complement-dependent cytotoxicity of rituximab, eculizumab may reduce the expected pharmacodynamic effects of rituximab.
Der fremkom ingen specielle bivirkninger i forbindelse med disse kliniske studier.
No specific adverse reactions have emerged from these clinical studies.
Der forventes ingen påvirkning af ammede nyfødte/spædbørn, da tilgængelige begrænsede data tyder på, at eculizumab ikke udskilles i human brystmælk.
No effects on the breastfed newborn / infant are anticipated as limited data available suggest that eculizumab is not excreted in human breast milk.
• Den fortyndede opløsning må ikke opvarmes i mikroovn eller anden varmekilde end den forekommende rumtemperatur.
• The diluted solution must not be heated in a microwave or with any heat source other than the prevailing room temperature.
Infektioner Inden du starter med at få Soliris, skal du fortælle det til lægen, hvis du har en infektion
Infections Before starting Soliris, inform your doctor if you have any infections.
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Engangshætteglas, glas type I
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Single use Type I glass vial
Der er ikke udført dyreforsøg til vurdering af eculizumabs genotoksiske potentiale og karcinogenicitet.
No animal studies have been conducted to evaluate the genotoxic and carcinogenic potential of eculizumab.
Den mest almindelige årsag til at ændre behandling med immunsuppressive midler var forbedring af MG-symptomer, mens de var i behandling med eculizumab.
The most common reason for change in immunosuppressant therapy was improvement in MG symptoms while on eculizumab treatment.
Krydsreaktiviteten af eculizumab over for andre væv blev vurderet ved bestemmelse af bindingen til et panel på 38 humane væv.
The tissue cross-reactivity of eculizumab was evaluated by assessing binding to a panel of 38 human tissues.