natgillin/translations-raw huggingface dataset:
Der krævedes ingen supplerende undersøgelser, da Zoledronic acid Teva Pharma er et generisk lægemiddel, der gives ved infusion og indeholder det samme aktive stof som referencelægemidlet Aclasta.
No additional studies were needed as Zoledronic acid Teva Pharma is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Aclasta.
Der er udarbejdet en risikostyringsplan for at sikre, at Zoledronic acid Teva Pharma anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Zoledronic acid Teva Pharma is used as safely as possible.
CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Zoledronic acid Teva Pharma er sammenlignelig med Aclasta.
The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Teva Pharma has been shown to be comparable to Aclasta.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zoledronic acid Teva Pharma.
This is a summary of the European public assessment report (EPAR) for Zoledronic acid Teva Pharma.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Zoledronic acid Teva Pharma, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Teva Pharma, including the appropriate precautions to be followed by healthcare professionals and patients.
Patienter, som har brækket hoften, bør først få Zoledronic acid Teva Pharma to uger efter operationen, hvor bruddet blev repareret.
Patients who have broken their hip should not receive Zoledronic acid Teva Pharma any earlier than two weeks after the operation to repair the fracture.
Zoledronic acid Teva Pharma gives som en infusion, der varer mindst 15 minutter.
Zoledronic acid Teva Pharma is given as an infusion lasting at least 15 minutes.
Zoledronic acid Teva Pharma er en opløsning til infusion (drop) i en vene, der indeholder det aktive stof zoledronsyre (5 mg).
Zoledronic acid Teva Pharma is a solution for infusion (drip) into a vein that contains the active substance zoledronic acid (5 mg).
Ved behandling af Pagets sygdom må Zoledronic acid Teva Pharma kun gives af en læge med erfaring i behandling af sygdommen.
In the treatment of Paget's disease of the bone, Zoledronic acid Teva Pharma must only be used by a doctor who has experience in the treatment of the disease.
Da Zoledronic acid Teva Pharma er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Zoledronic acid Teva Pharma is a generic, its benefits and risks are taken as being the same as the reference medicine's.
Zoledronic acid Teva Pharma bør ikke anvendes til patienter, som har svære nyreproblemer.
Zoledronic acid Teva Pharma should not be used in patients with severe kidney problems.
Det aktive stof i Zoledronic acid Teva Pharma, zoledronsyre, er et bisphosphonat.
The active substance in Zoledronic acid Teva Pharma, zoledronic acid, is a bisphosphonate.
Zoledronic acid Teva Pharma anvendes også til at behandle Pagets knoglesygdom hos voksne.
Zoledronic acid Teva Pharma is also used to treat Paget's disease of the bone in adults.
Zoledronic acid Teva Pharma anvendes til behandling af osteoporose (en sygdom, der gør knoglerne skøre) hos kvinder, der har været gennem overgangsalderen, og hos mænd.
Zoledronic acid Teva Pharma is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zoledronic acid Teva Pharma?
What measures are being taken to ensure the safe and effective use of Zoledronic acid Teva Pharma?
Zoledronic acid Teva Pharma zoledronsyre
Zoledronic acid Teva Pharma zoledronic acid
Andre oplysninger om Zoledronic acid Teva Pharma
Other information about Zoledronic acid Teva Pharma
Hvilke fordele og risici er der forbundet med Zoledronic acid Teva Pharma?
What are the benefits and risks of Zoledronic acid Teva Pharma?
Zoledronic acid Teva Pharma er et ”generisk lægemiddel”.
Zoledronic acid Teva Pharma is a ‘generic medicine'.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Zoledronic acid Teva Pharma.
The Committee recommended that Zoledronic acid Teva Pharma be given marketing authorisation.
Hvorfor blev Zoledronic acid Teva Pharma godkendt?
Why has Zoledronic acid Teva Pharma been approved?
Hvad er Zoledronic acid Teva Pharma?
What is Zoledronic acid Teva Pharma?
Hvordan blev Zoledronic acid Teva Pharma undersøgt?
How has Zoledronic acid Teva Pharma been studied?
Hvordan anvendes Zoledronic acid Teva Pharma?
How is Zoledronic acid Teva Pharma used?
Hvordan virker Zoledronic acid Teva Pharma?
How does Zoledronic acid Teva Pharma work?
Hvad anvendes Zoledronic acid Teva Pharma til?
What is Zoledronic acid Teva Pharma used for?
Det er forventeligt, og du skal ikke været bekymret over det.
This is to be expected and you should not be concerned
Din læge vil fortælle dig, hvis dette gælder for dig.
Your doctor will tell you if this applies to you.
3 parallelle arme:
3 Parallel arms:
Denne forskel anses dog ikke for at være klinisk relevant.
However, this difference is not considered to be clinically relevant.
De maksimale effekter blev generelt observeret inden for 6 uger.
Maximum effects were generally observed within 6 weeks.
• japanske eller koreanske patienter.
• Japanese or Korean patients.
Dato for første markedsføringstilladelse: 22. marts 2017
Date of first authorisation: 22 March 2017
Aktiv kontrol (ADA)
Active control (ADA)
Denne behandlingsforskel var konsistent mellem de to undergrupper (Tabel 16).
This treatment difference was consistent between the 2 subgroups (Table 16).
OPAL BEYOND havde en varighed på 6 måneder.
OPAL BEYOND had a duration of 6 months.
Behandlingen skal være symptomatisk og støttende.
Treatment should be symptomatic and supportive.
Tal med din læge, hvis du ryger.
Talk to your doctor if you smoke.
Der blev observeret stigninger på dette tidspunkt, og de forblev herefter stabile.
Increases were observed at this time point and remained stable thereafter.
Malariamidler var tilladt.
Antimalarials were allowed.
Ikke kendt (kan ikke estimeres ud fra forhåndenværen de data
Not known (cannot be estimated from the available data)
Tag den næste tablet på det sædvanlige tidspunkt og fortsæt som før.
Take your next tablet at the usual time and continue as before.
Der var ingen klar relation mellem neutropeni og forekomst af alvorlige infektioner.
There was no clear relationship between neutropenia and the occurrence of serious infections.
PK Ratio og 90 % CI
PK Ratio and 90% CI
Ratio i forhold til reference
Ratio relative to reference
Der er ikke udført formelle studier af den mulige effekt på human fertilitet.
Formal studies of the potential effect on human fertility have not been conducted.
Seponeringsperioden i kliniske studier strakte sig op til 1 år.
The treatment interruption period in clinical studies extended up to 1 year.
• Hvis din behandling afbrydes, kan din læge beslutte at starte din behandling på ny.
• If your treatment is interrupted, your doctor may decide to restart your treatment.
Genbehandling ved UC
Retreatment in UC
Disse responser var lig det, der blev observeret hos raske frivillige på 50 år og derover.
These responses were similar to those observed in healthy volunteers aged 50 years and older.
Visse patienter viste dissemineret snarere end lokaliseret sygdom.
Some patients have presented with disseminated rather than localised disease.
Child Pugh A Ingen dosisjustering påkrævet.
Child Pugh A No dose adjustment required.
Han/hun vil også tage stilling til om din vægt, alder eller mobilitetsproblemer kan påvirke risikoen for, at du udvikler blodpropper.
He / she will also evaluate whether your body weight, age, or problems being mobile will affect your risk to develop blood clots.
*Spontant rapporterede data.
*Spontaneous reporting data
Du kan tage XELJANZ med eller uden mad.
You can take XELJANZ with or without food.
• som har underliggende tilstande, der kan prædisponere for infektion
• who have underlying conditions that may predispose them to infection.
De tilgængelige data viser også, at der ikke er nogen større forskel i AUC for tofacitinib mellem hvide, sorte og asiatiske patienter.
The available data have also shown that there are no major differences in tofacitinib AUC between White, Black and Asian patients.
Der foreligger ikke tilstrækkelige og velkontrollerede studier med anvendelse af tofacitinib hos gravide kvinder.
There are no adequate and well-controlled studies on the use of tofacitinib in pregnant women.
Din læge vil afgøre, om du har brug for en vaccine mod herpes zoster.
Your doctor will decide whether you need to have herpes zoster vaccination.
Disse ændringer forsvandt generelt inden for 2-6 uger efter seponering.
These changes generally resolved within 2-6 weeks after discontinuation of treatment.
Sørg for at tage tabletten på samme tidspunkt hver dag (en tablet om morgenen og en tablet om aftenen).
Try to take your tablet at the same time every day (one tablet in the morning and one tablet in the evening).
BID = To gange dagligt.
BID=twice daily.
For patienter med en baseline score > 0.
For patients with Baseline score > 0.
Vedligeholdelse (OCTAVE Sustain)
Maintenance (OCTAVE Sustain)
Behandlingsgrupper (Randomiseringsratio)
Treatment groups (randomisation ratio)
Du skal fortælle det til lægen, hvis du bruger medicin (som tages gennem munden), der indeholder et eller flere af følgende aktive stoffer:
You should tell your doctor if you are using medicines (taken by mouth) that contain any of the following active substances:
Det var påkrævet, at patienterne havde aktiv plaque psoriasis ved screeningsbesøget.
Patients were required to have active plaque psoriasis at the screening visit.
Nogle af bivirkningerne kan være alvorlige og kræve lægehjælp.
Some may be serious and need medical attention.
Fortæl det straks til lægen, hvis du føler dig utilpas.
Tell your doctor immediately if you feel unwell.
Brug ikke denne medicin, hvis du opdager, at tabletterne udviser tegn på beskadigelse (for eksempel er gået i stykker eller er misfarvede).
Do not use this medicine if you notice the tablets show visible signs of deterioration (for example, are broken or discoloured).
Bemærk: Reference er administration af tofacitinib alene.
Note: Reference group is administration of tofacitinib alone.
- hvis du har eller har haft hepatitis B eller hepatitis C (virus, som påvirker leveren).
- if you have or had hepatitis B or hepatitis C (viruses that affect the liver).
Fortæl det til lægen, så snart du bemærker tegn eller symptomer på en infektion.
Tell your doctor as soon as you notice any signs or symptoms of infections.
Kombination med andre behandlinger
Combination with other therapies
Måned 6- og Måned 12-data er den gennemsnitlige ændring fra baseline d
Month 6 and month 12 data are mean change from baseline d
Tofacitinib gives oralt med eller uden mad.
Tofacitinib is given orally with or without food.
Én gang dagligt Undlad at synke tørremidlet.
Once daily Do not swallow the desiccant.
Tofacitinib absorberes godt og har en oral biotilgængelighed på 74 %.
Tofacitinib is well-absorbed, with an oral bioavailability of 74%.
Det blev estimeret, at AUC for kvinder er 7 % mindre end for mænd.
Women were estimated to have 7% lower AUC compared to men.
Tofacitinib fordeles ligeligt mellem røde blodlegemer og plasma.
Tofacitinib distributes equally between red blood cells and plasma.
N = Antallet af patienter i analysesættet.
N=number of patients in the analysis set.
SD = Standardafvigelse b
SD = Standard Deviation b
Indholdet af sorbitol i lægemidler til oral brug kan påvirke biotilgængeligheden af andre lægemidler til oral brug ved samtidig administration.
The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
• Patienter, som undergår større operationer
• Patients undergoing major surgery
Helbredsrelateret livskvalitet blev vurderet ved hjælp af Short Form Health Survey (SF-36).
Health-related quality of life was assessed by the Short Form Health Survey (SF-36).
• har været eksponeret for TB
• who have been exposed to TB,
Antallet af patienter med artritis mutilans eller aksial involvering var for lille til at kunne foretage en meningsfuld vurdering.
The number of patients with arthritis mutilans or axial involvement was too small to allow meaningful assessment.
Medianvarighed af PsA var 7,5 år.
The median PsA disease duration was 7.5 years.
Medianvarighed af PsA var 3,8 år.
The median PsA disease duration was 3.8 years.
Behandlingen skal afbrydes, hvis en patient udvikler en alvorlig infektion, en opportunistisk infektion eller sepsis.
Treatment should be interrupted if a patient develops a serious infection, an opportunistic infection, or sepsis.
Effektresultaterne for de vigtige effektmål er vist i tabel 12.
The efficacy results for important endpoints assessed are shown in Table 12.
XELJANZ kan øge din risiko for visse former for kræft.
XELJANZ may increase your risk of certain cancers.
Denne sygdom er en betændelsessygdom i leddene, som ofte er ledsaget af psoriasis.
This condition is an inflammatory disease of the joints, often accompanied by psoriasis.
Nedtrapning af kortikosteroider var også påkrævet ved inklusionen i OCTAVE Open.
Corticosteroid tapering was also required upon entrance into OCTAVE Open.
- hvis du har problemer med hjertet, forhøjet blodtryk eller forhøjet kolesterol.
- if you have heart problems, high blood pressure, or high cholesterol
Tofacitinib bør ikke påbegyndes hos patienter med aktive infektioner, inklusive lokale infektioner.
Tofacitinib should not be initiated in patients with active infections, including localised infections.
Før lancering af XELJANZ i de enkelte EU-lande skal MAH aftale indhold og form af uddannelsesprogrammet, herunder kommunikation med medier, distribution af materialet og andre aspekter af programmet med den nationale lægemiddelmyndighed.
Prior to launch of XELJANZ in each Member State, the MAH must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Yderligere risikofaktorer, som bør tages i betragtning, når patientens risiko for PE skal afgøres, er alder, overvægt, rygerstatus og immobilisering.
Additional risk factors that should be considered in determining the patient's risk for PE are older age, obesity, smoking status, and immobilisation.
Behandlingseffekten var sammenlignelig hos patienterne uafhængigt af status af reumafaktor, alder, køn, race eller sygdomsstatus.
The treatment effect was similar in patients independent of rheumatoid factor status, age, gender, race, or disease status.
Tabel 7 indeholder oplysninger om relevante karakteristika for studiedesign og populationer.
Table 7 provides information regarding the pertinent study design and population characteristics.
Andre bivirkninger, der er blevet observeret med XELJANZ, er anført nedenfor.
Other side effects which have been observed with XELJANZ are listed below.
Alvorlige bivirkninger I sjældne tilfælde kan infektioner være livstruende.
Possible serious side effects In rare cases, infection may be life-threatening.
macrogol og triacetin (E1518).
macrogol, and triacetin (E1518).
For patienter med en baseline BSA på ≥ 3 % og PASI > 0.
For patients with Baseline BSA ≥ 3% and PASI > 0.
• Yderligere risikominimeringstiltag
• Additional risk minimisation measures
Der foreligger ingen data om sekundær transmission af infektion via levende vacciner til patienter, der får tofacitinib.
No data are available on the secondary transmission of infection by live vaccines to patients receiving tofacitinib.
Antal patienter behandlet Samlet studievarighed
Number of patients treated Total study duration
Farmakoterapeutisk klassifikation: Immunsuppresiva, selektive immunsuppressiva, ATC-kode: L04AA29
Pharmacotherapeutic groups: Immunosuppressants, Selective Immunosuppressants; ATC code: L04AA29
Der skal tages højde for den additive effekt af samtidigt administrerede produkter indeholdende sorbitol (eller fruktose) og indtagelse af sorbitol (eller fruktose) gennem kosten.
The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Endvidere blev tofacitinibs sikkerhed og effekt vurderet i et åbent, langvarigt forlængelsesstudie (OCTAVE Open).
In addition, safety and efficacy of tofacitinib were assessed in an open-label long-term extension study (OCTAVE Open).
Lægen kan også udføre andre tests, såsom at tjekke kolesterolindholdet i dit blod eller undersøge, hvor godt din lever fungerer.
Your doctor may also perform other tests, for example to check your blood cholesterol levels or monitor the health of your liver.
man., tir., ons., tor., fre., lør., søn.
Mon., Tue., Wed., Thu., Fri., Sat., Sun.
Farmakokinetiske data hos raske frivillige til og med en enkelt dosis på 100 mg antyder, at mere end 95 % af den administrerede dosis kan forventes at blive elimineret inden for 24 timer.
Pharmacokinetic data up to and including a single dose of 100 mg in healthy volunteers indicate that more than 95% of the administered dose is expected to be eliminated within 24 hours.
Lægen bør undersøge din leverfunktion med jævne mellemrum.
Your doctor should perform liver tests periodically.
Lægen kan nedsætte din dosis, hvis du har problemer med leveren eller nyrerne, eller hvis du får ordineret visse andre lægemidler.
Your doctor may reduce the dose if you have liver or kidney problems or if you are prescribed certain other medicines.
XELJANZ anbefales ikke til børn eller unge under 18 år.
XELJANZ is not recommended for use in children or adolescents under 18 years of age.
Ændringer i antal cirkulerende T-lymfocytter og undergrupper af T-lymfocytter (CD3+, CD4+ og CD8+) var små og inkonsistente.
Changes in circulating T-lymphocyte counts and T-lymphocyte subsets (CD3+, CD4+ and CD8+) were small and inconsistent.
Kan nedsætte effekten
Efficacy may be decreased
Fortæl det straks til lægen, hvis du bliver gravid, mens du tager XELJANZ.
Tell your doctor right away if you become pregnant while taking XELJANZ.
Hos forsøgspersoner med nyresygdom i slutstadium (ESRD) var bidraget fra dialyse til den totale clearance af tofacitinib relativt lille.
In subjects with end-stage renal disease (ESRD), contribution of dialysis to the total clearance of tofacitinib was relatively small.
Tofacitinib bindes hovedsageligt til albumin og synes ikke at binde til surt 1-glykoprotein.
Tofacitinib binds predominantly to albumin and does not appear to bind to 1-acid glycoprotein.
• som har været bosat eller rejst i områder med endemiske mykoser
• who have resided or travelled in areas of endemic mycoses,
• Din læge kan beslutte at stoppebehandlingen med XELJANZ, hvis XELJANZ ikke virker for dig inden for 16 uger.
• Your doctor may decide to stop XELJANZ if XELJANZ does not work for you within 16 weeks.
Clearance-mekanismer for tofacitinib er cirka 70 % hepatisk metabolisme og 30 % renal udskillelse af uomdannet lægemiddel.
Clearance mechanisms for tofacitinib are approximately 70% hepatic metabolism and 30% renal excretion of the parent drug.
Tofacitinib med og uden MTX sammenlignet med ADA med MTX
Tofacitinib with and without MTX in comparison to ADA with MTX
De hyppigst rapporterede infektioner var øvre luftvejsinfektioner og nasofaryngitis (henholdsvis 3,7 % og 3,2 %).
The most commonly reported infections were upper respiratory tract infections and nasopharyngitis (3.7% and 3.2%, respectively).
Patienter skulle have klinisk respons ved baseline i vedligeholdelsesstudiet OCTAVE Sustain.
Patients were to be in clinical response at baseline of the maintenance study OCTAVE Sustain.
Periodisk undersøgelse af huden anbefales for patienter, der har øget risiko for hudkræft (se tabel 6 i pkt.
Periodic skin examination is recommended for patients who are at increased risk for skin cancer (see Table 6 in section 4.8).
Efter intravenøs administration er fordelingsvolumenet 87 l. Cirka 40 % af cirkulerende tofacitinib bindes til plasmaproteiner.
After intravenous administration, the volume of distribution is 87 L. Approximately 40% of circulating tofacitinib is bound to plasma proteins.
Der blev observeret et omtrent lineært forhold mellem kropsvægt og fordelingsvolumen, hvilket resulterer i højere maksimumskoncentrationer (Cmax) og lavere minimumskoncentrationer (Cmin) hos slankere patienter.
An approximate linear relationship between body weight and volume of distribution was observed, resulting in higher peak (Cmax) and lower trough (Cmin) concentrations in lighter patients.
Vaccination med levende vacciner bør ske mindst 2 uger, men helst 4 uger før behandling med tofacitinib initieres eller i overensstemmelse med gældende retningslinjer for vaccination med immunmodulerende lægemidler.
Vaccination with live vaccines should occur at least 2 weeks but preferably 4 weeks prior to initiation of tofacitinib or in accordance with current vaccination guidelines regarding immunomodulatory medicinal products.
Åbent forlængelsesstudie (OCTAVE Open)
Open-label extension study (OCTAVE Open)
Du skal altid have dette patientkort på dig.
Keep this Patient Alert Card with you.
Det vides ikke, om tofacitinib udskilles i human mælk.
It is not known whether tofacitinib is secreted in human milk.
Der er ikke nogen specifik antidot mod en overdosis af tofacitinib.
There is no specific antidote for overdose with tofacitinib.
Den inter-individuelle variation (variationskoefficient i %) i AUC for tofacitinib anslås at være cirka 27 %.
The between-subject variability (percentage coefficient of variation) in AUC of tofacitinib is estimated to be approximately 27%.
Virussen kan blive aktiv, mens du tager XELJANZ.
The virus may become active while you are taking XELJANZ.
Pfizer Europe MA EEIG (som MA logo)
Pfizer Europe MA EEIG (as MA holder logo)
Patienter, der ved screening var positive for hepatitis B eller C, blev ekskluderet fra kliniske studier.
Patients screened positive for hepatitis B or C were excluded from clinical trials.
Patienter i fase 3-studierne havde en gennemsnitlig Disease Activity Score (DAS28-4[ESR]) på 6,1-6,7 ved baseline.
Patients in the phase 3 studies had a mean Disease Activity Score (DAS28-4[ESR]) of 6.1-6.7 at baseline.
Profylaktisk zoster-vaccination bør overvejes i henhold til gældende retningslinjer.
Prophylactic zoster vaccination should be considered in accordance with vaccination guidelines.
Ændringer i lipidparametre i forhold til baseline frem til slutningen (6-24 måneder) af de kontrollerede kliniske RA-studier opsummeres nedenfor:
Changes in lipid parameters from baseline through the end of the study (6-24 months) in the controlled clinical studies in RA are summarised below:
Det er den tomme skal fra depottabletten, der bliver tilbage, når din krop har absorberet lægemidlet.
This is the empty shell from the prolonged-release tablet after the medicine has been absorbed by your body.
• Aktiv tuberkulose (TB), alvorlige infektioner såsom sepsis, opportunistiske infektioner (se pkt.
• Active tuberculosis (TB), serious infections such as sepsis, or opportunistic infections (see section 4.4).
Hvis du har aktiv psoriasisgigt, vil du først få en anden medicin til at behandle din psoriasisgigt.
If you have active psoriatic arthritis you will be first given another medicine to treat your psoriatic arthritis.
En patient uden varicella-infektion i anamnesen og ingen antistoffer mod varicella ved baseline oplevede disseminering af den varicella-stamme, der var i vaccinen, 16 dage efter vaccinationen.
A patient with no previous history of varicella infection and no anti-varicella antibodies at baseline experienced dissemination of the vaccine strain of varicella 16 days after vaccination.
• har boet eller rejst i områder med endemisk TB.
• who have resided or travelled in areas of endemic TB.