natgillin/translations-raw huggingface dataset:
• behandling af moderat til svært aktiv Crohns sygdom hos voksne patienter, som ikke har responderet på trods af en fuldstændig og adækvat behandling med et kortikosteroid og/eller et immunsuppressivum, eller som er intolerante over for eller har kliniske kontraindikationer for sådanne behandlinger.
Adult Crohn's disease Flixabi is indicated for:  treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
≤ 3 års sygdomsvarighed, median 0,6 år) aktiv reumatoid arthritis (median antallet af hævede og ømme led var henholdsvis 19 og 31).
The ASPIRE study evaluated responses at 54 weeks in 1,004 methotrexate naive patients with early (≤ 3 years disease duration, median 0.6 years) active rheumatoid arthritis (median swollen and tender joint count of 19 and 31, respectively).
• Fornyet indgift: Doser på 5 mg/kg, hvis sygdomstegn og symptomer på sygdommen kommer igen, efterfulgt af infusionsdoser på 5 mg/kg hver 8. uge (se "Fornyet indgift" nedenfor samt pkt.
In responding patients, the alternative strategies for continued treatment are:  Maintenance: Additional infusions of 5 mg/kg every 8 weeks or  Re-administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur followed by infusions of 5 mg/kg every 8 weeks (see ‘Re-administration' below and section 4.4).
Terapeutiske smitstoffer bør ikke gives samtidig med Flixabi.
It is recommended that therapeutic infectious agents not be given concurrently with Flixabi.
Vedvarende respons (klinisk respons både i uge 8 og uge 30)a
Sustained response (clinical response at both week
Det drejede sig om 4 ud af 22 (18,2 %) i 8-ugers vedligeholdelsesbehandlingsgruppen og 3 ud af 23 (13,0 %) i 12-ugers vedligeholdelsesbehandlingsgruppen.
Overall, 8 (13.3%) of 60 treated patients experienced one or more infusion reactions, with 4 of 22 (18.2%) in the q8 week and 3 of 23 (13.0%) in the q12 week treatment maintenance group.
Hvert Flixabi-hætteglas indeholder 100 mg infliximab.
Each Flixabi vial contains 100 mg infliximab.
Fortæl straks din læge, hvis du får tegn på TB under behandlingen med Flixabi.
Tell your doctor straight away if you get signs of TB during treatment with Flixabi.
Et hætteglas indeholder 100 mg infliximab*.
One vial contains 100 mg of infliximab*.
Der er ikke tilgængelige data om antiviral behandling profylaktisk mod HBV-reaktivering i forbindelse med TNF-antagonist-behandling hos patienter, som er bærere af HBV. Flixabi bør seponeres hos patienter, hvor HBV reaktiveres, og effektiv antiviral behandling med passende understøttende behandling bør igangsættes.
In patients who develop HBV reactivation, Flixabi should be stopped and effective antiviral therapy with appropriate supportive treatment should be initiated.
Psykiske forstyrrelser Almindelig:
Nervous system disorders Very common:
Kortvarigt synstab under infusionen eller inden for 2 timer efter infusionen.
Transient visual loss occurring during or within 2 hours of infusion.
DANMARK
DENMARK
Fortæl straks din læge, hvis du får tegn på infektion under behandling med Flixabi.
Tell your doctor straight away if you get signs of infection during treatment with Flixabi.
• Kulderystelser, hævelse på grund af ophobning af væske under huden
• Chills, a build up of fluid under the skin causing swelling
Infliximabs sikkerhed og virkning blev vurderet i et multicenter, randomiseret, open-label, parallelgruppe klinisk studie (C0168T72) hos 60 pædiatriske patienter i alderen 6 til 17 år (medianalder
The safety and efficacy of infliximab were assessed in a multicentre, randomised, open-label, parallel-group clinical study (C0168T72) in 60 paediatric patients aged 6 through 17 years (median age 14.5 years) with moderately to severely active ulcerative colitis (Mayo score of 6 to 12; endoscopic subscore ≥ 2) with an inadequate response to conventional therapies.
Fornyet indgift ved ankyloserende spondylitis Sikkerhed og virkning ved fornyet indgift, udover hver 6. til 8. uge, er ikke klarlagt (se pkt.
The safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established (see sections 4.4 and 4.8).
Fortæl det straks til lægen, hvis du får symptomer på lave blodtal under behandlingen med Flixabi.
Tell your doctor straight away if you get symptoms of low blood counts during treatment with Flixabi.
Efter rekonstitution indeholder hver ml 10 mg infliximab.
After reconstitution, each ml contains 10 mg of infliximab.
Efter klargøring indeholder hver ml 10 mg infliximab.
After preparation each mL contains 10 mg of infliximab.
Terapeutiske smitstoffer bør ikke gives samtidig med Flixabi (se pkt.
It is recommended that therapeutic infectious agents not be given concurrently with Flixabi (see section 4.4).
Lever- og galdevejshændelser I kliniske studier er let til moderate stigninger i ALAT og ASAT set hos patienter, der fik infliximab,
In clinical studies, mild or moderate elevations of ALT and AST have been observed in patients receiving infliximab without progression to severe hepatic injury.
Det er vigtigt, at du fortæller dit barns læger og andet sundhedspersonale, at du har fået Flixabi, før barnet bliver vaccineret (for mere information, se afsnit om vaccination).
• It is important that you tell your baby's doctors and other healthcare professionals about your Flixabi use before your baby is given any vaccine.
Slimhindeheling i uge 30a a p < 0,001 for hver infliximab-behandlingsgruppe mod placebo.
a a p < 0.001, for each infliximab treatment group vs. placebo
Fortæl straks din læge, hvis du får symptomer på en nervesygdom under behandlingen med Flixabi.
Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Flixabi.
Gennemsnit ± SDa
Mean ± SD
Så meget Flixabi vil du få
How much Flixabi is given
Efter rekonstitution indeholder 1 ml 10 mg infliximab.
After reconstitution one mL contains 10 mg infliximab.
Gennemsnit ± SDd a p < 0,001, for hver infliximab-behandlingsgruppe mod kontrol.
Mean ± SDd a p < 0.001, for each infliximab treatment group vs control b greater values indicate more joint damage.
Hvis patienten ikke responderer efter 2 doser, bør der ikke behandles yderligere med Flixabi.
If a patient does not respond after 2 doses, no additional treatment with Flixabi should be given.
Icepharma hf Sími: + 354 800 9836
Sími: + 354 800 9836
• voksne patienter med aktiv sygdom, når responset til sygdomsmodulerende antireumatiske lægemidler (DMARDs), inklusive methotrexat, har været utilstrækkeligt.
(DMARDs), including methotrexate, has been inadequate.
Fortæl det straks til lægen, hvis du får symptomer på lupus under behandlingen med Flixabi.
Tell your doctor straight away if you develop symptoms of lupus during treatment with Flixabi.
** PASI 75 respons for IMPACT ikke inkluderet som følge af lav N; p < 0,001 for infliximab vs. placebo i uge 24 for IMPACT 2.
* ITT-analysis where subjects with missing data were included as non-responders a Week 98 data for IMPACT includes combined placebo crossover and infliximab patients who entered the open-label extension b Based on patients with PASI ≥ 2.5 at baseline for IMPACT, and patients with ≥ 3% BSA psoriasis skin involvement at baseline in IMPACT 2 ** PASI 75 response for IMPACT not included due to low N; p < 0.001 for infliximab vs. placebo at week 24 for IMPACT 2
Almindelig: kan forekomme hos op til 1 ud af 10 personer
Common: may affect up to 1 10 people
I det andet kliniske studie (IMPACT 2) blev effekt og sikkerhed af infliximab undersøgt hos 200
In the second clinical study (IMPACT 2), efficacy and safety of infliximab were studied in 200 patients with active psoriatic arthritis (≥ 5 swollen joints and ≥ 5 tender joints).
Luftveje, thorax og mediastinum Meget almindelig: Øvre luftvejsinfektion, sinuitis.
Respiratory, thoracic and mediastinal disorders Very common:
• Leversvigt
(furunculosis)
Før behandlingen med Flixabi påbegyndes, skal patienten testes for HBV-infektion.
Patients should be tested for HBV infection before initiating treatment with Flixabi.
Du må ikke få Flixabi og Kineret samtidig.
Flixabi and Kineret should not be used together.
Brug ikke Flixabi
AZA Monotherapy
Fortæl det straks til lægen, hvis du får symptomer på leverproblemer under behandlingen med Flixabi.
Tell your doctor straight away if you get symptoms of liver problems during treatment with Flixabi.
Patientinformationskortet skal udleveres til patienter, som er i behandling med Flixabi.
Patients treated with Flixabi should be given the patient reminder card.
Ikke almindelig: kan forekomme hos op til 1 ud af 100 personas
Uncommon: may affect up to1 in 100 people
Mave-tarm-kanalen
Olof Palmestraat 10
Keratitis, periorbitalt ødem, bygkorn.
Keratitis, periorbital oedema, hordeolum.
Flixabi bør administreres
How Flixabi is given
drænet ved forsigtigt tryk, ved mindst to på hinanden følgende besøg (med 4 ugers mellemrum) uden øget brug af lægemidler eller kirurgisk indgreb for Crohns sygdom.
The primary endpoint was the proportion of patients who experienced a clinical response, defined as ≥ 50% reduction from baseline in the number of fistulae draining upon gentle compression on at least two consecutive visits (4 weeks apart), without an increase in the use of medicinal products or surgery for Crohn's disease.
HAQ ændring fra baseline over tiden e
HAQ change from baseline over timee (patients evaluated) Mean ± SD
Fornyet indgift ved psoriasis arthritis Sikkerhed og virkning ved fornyet indgift, udover hver 8. uge, er ikke klarlagt (se pkt.
The safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8).
Kontrol a 3 mg/kg hver 8. uge
3 mg/kg q 8 wks
(van der Heijdemodified Sharp score) Ændring fra baseline (Gennemsnit ± SD
Patients with ACR20 response/ Patients evaluated (%) Total scored (van der Heijde-modified Sharp score) Change from baseline (Mean ± SD
Procent forsøgspersoner med slimhindeheling Slimhindeheling i uge 8a
Percentage of subjects with mucosal healing Mucosal healing at week 8
Flixabi.
Apathy.
Sådan skal du bruge Flixabi
How to store Flixabi
Opbevaring
Indication
(hepatosplenisk T-celle- lymfom)
(anaphylactic shock)
Ydermere er der efter markedsføring blevet rapporteret tilfælde af hepatosplenisk T-celle- lymfom hos patienter i behandling med infliximab.
Post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with TNFblocking agents including infliximab.
Artralgi, myalgi, rygsmerter.
Arthralgia, myalgia, back pain.
Hos patienter, som fik infliximab, er langt de fleste tilfælde forekommet hos patienter med Crohns sygdom eller colitis ulcerosa, og de fleste blev rapporteret hos unge og unge voksne mænd.
In addition, post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with infliximab with the vast majority of cases occurring in Crohn's disease and ulcerative colitis, and most of whom were adolescent or young adult males (see section 4.4).
Instruktion i anvendelse og håndtering - rekonstitution, fortynding og administration
Instructions for use and handling - reconstitution, dilution and administration In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered medicinal product should be clearly recorded.
5 mg/kg (i uge 24)
5 mg/kg
behandlet med 3 infusioner infliximab 5 mg/kg, 10 mg/kg eller placebo i løbet af 6 uger.
In this study 150 patients with NYHA Class III-IV CHF (left ventricular ejection fraction ≤ 35%) were treated with 3 infusions of infliximab 5 mg/kg, 10 mg/kg, or placebo over 6 weeks.
Patienterne fik placebo, 3 mg/kg eller 10 mg/kg infliximab i ugerne 0, 2 og 6, samt hver 4. eller 8. uge herefter.
Patients received placebo, 3 mg/kg or 10 mg/kg infliximab at weeks 0, 2
Reumatoid arthritis Crohns sygdom2
Rheumatoid arthritis1
Lever- og galdevejshændelser
Autoimmune processes
(anafylaktisk shock) • Hævelse af små blodkar (blodkarbetændelse)
• Swelling of small blood vessels (vasculitis)
Analysen var baseret på patienter med neglepsoriasis ved baseline (81,8 % af patienterne).
a p < 0.001, for each infliximab treatment group vs. control b n = 292 c Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
1 glas med 180 tabletter uden ydre pakning
Bottle (HDPE) 1 bottle of 180 tablets without outer carton
Pakningsstørrelse
Package sizes
Lægemiddelform Indgivelsesvej
Invented name Strengths Pharmaceutical Forms Route of Administration Packaging
Tal med Deres læge, hvis De er over 65 år.
Talk to your doctor if you are over 65.
Hvis De glemmer en dosis
If you miss a dose
Dato for åbning: ___________
Date of opening:___________
Dato for første markedsføringstilladelse: 8. december 2016
Date of first authorisation: 8 December 2016
- Risikostyringsplan (RMP)
- Risk Management Plan (RMP)
Bliv testet for HIV regelmæssigt.
Get tested for HIV regularly.
- Påmindelser om evaluering/rådgivning ved det indledende besøg og ved opfølgning.
- Reminders for evaluations/counselling at the initial visit and follow-up.
- Øvrige indholdsstoffer er:
- The other ingredients are:
Anbefales ikke til brug i denne population.
Not recommended for use in this population.
IB = ikke beregnet.
NC = not calculated.
Tag altid den dosis, Deres læge har anbefalet.
Always take the dose recommended by your doctor.
→ Fortæl Deres læge, hvis De tager nogen af disse lægemidler.
→ Tell your doctor if you are taking any of these medicines.
- Påmindelse om, hvad den pågældende skal vide før og under indtagelse af
- Reminders on what the individual should know before and while taking
Forsøgspersonerne blev fulgt i 4.237 personår.
Subjects were followed for 4,237 personyears.
- Yderligere risikominimerende foranstaltninger
- Additional risk minimisation measures
- Påmindelse om at overholde doseringsplanen - Påmindelse om at møde frem til planlagte klinikbesøg.
- Reminders to adhere to the dosing schedule - Reminder to attend scheduled clinic visits.
→ Hvis dette gælder for Dem, skal De omgående fortælle Deres læge det.
→ If this applies to you, tell your doctor immediately.
Bliv testet for andre seksuelt overførbare infektioner, såsom syfilis og gonorré.
- Get tested for other sexually transmitted infections such as syphilis and gonorrhoea.
De må ikke ændre Deres dosis medmindre De har fået besked på det af Deres læge.
Do not change the dose unless your doctor tells you to.
Overførsel af HIV
Transmission of HIV
På den trykte indlægsseddel for lægemidlet skal der anføres navn og adresse på fremstilleren ansvarlig for frigivelsen af den pågældende batch.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
For at sikre, at medicinen er fuldt ud effektiv, og for at reducere udviklingen af resistens mod behandlingen.
This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment.
Begge disse aktive stoffer er antiretroviral medicin, som anvendes til behandling af hiv-infektion.
Both of these active substances are antiretroviral medicines which are used to treat HIV infection.
OPA/Alu/PE+DES/ - Aluminium blistere.
OPA/Alu/PE+DES/ - Aluminium blisters.
Profylaktisk brug af før eksponering hos personer med ukendt eller positiv hiv 1-status.
Use for pre exposure prophylaxis in individuals with unknown or positive HIV 1 status.
Serokonverteringer / N
Seroconversions / N
Lad være med at dele eller genbruge nåle og andet injektions- eller lægemiddeludstyr.
- Do not share or re-use needles or other injection or drug equipment.
Personer, der er hiv-positive, kan stadig overføre hiv, når De tager denne medicin, selvom risikoen sænkes ved effektiv antiretroviral behandling.
People who are HIV positive can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
3, nefrogen diabetes insipidus
3, nephrogenic diabetes insipidus
- på anmodning fra Det Europæiske Lægemiddelagentur; - når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
- At the request of the European Medicines Agency; - Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Hvis De mener, at De blev smittet med HIV, skal De straks fortælle Deres læge om det.
If you think you were infected with HIV, tell your doctor straight away.
P-værdier efter logrank test. P-værdien for URAI henviser til den nulhypotese, at virkningen var forskellig mellem undergruppestrata (URAI, ingen URAI).
P-values by logrank test. P-values for URAI refer to the null hypothesis that efficacy differed between subgroup strata (URAI, no URAI).
For lipider er der i visse tilfælde evidens for en behandlingsrelateret virkning, mens der for vægtstigning ikke er nogen stærk evidens, som relaterer dette til en bestemt behandling.
For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
Som det kunne forventes, forekom stigninger i ASAT og ALAT dog hyppigere hos denne patientpopulation end i den generelle hiv-inficerede population.
However, as would be expected in this patient population, elevations in AST and ALT occurred more frequently than in the general HIV infected population.
** p-værdien baseret på Cochran-Mantel-Haenszel-testen stratificeret til CD4-celletal ved baseline TLOVR = Time to Loss of Virologic Response (tiden til tab af virologisk respons) a:
** The p-value based on the Cochran-Mantel-Haenszel Test stratified for baseline CD4 cell count TLOVR = Time to Loss of Virologic Response a: Van Elteren Test
Antal med Detekteret Tenofovir/ Samlet Prøveantal (%)
Number with Tenofovir Detected/ Total Samples (%)
Anæmi var almindelig og misfarvning af huden (øget pigmentering) var meget almindelig, når emtricitabin blev administreret til pædiatriske patienter.
Anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients.
- Ingen analyseret virus indeholdt K65R- eller K70E-mutationen.
- No virus analysed contained the K65R or K70E mutation.
Køn, N (%)
Race, N (%)
Deltagerne i delstudiet modtog aktiv adhærensmonitorering, f.eks. uanmeldt hjemmebesøg og pilletælling, samt rådgivning i at forbedre komplians med studiemedicinen.
Substudy participants received active adherence monitoring, e.g. unannounced home visits and pill counts, and counselling to improve compliance with study drug.
Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug; antivirale midler til behandling af hiv-infektioner, kombinationer.
Pharmacotherapeutic group: Antiviral for systemic use; antivirals for treatment of HIV infections, combinations.
Hvis De er en kvinde med hiv, anbefales det, at De ikke ammer for at undgå at overføre virus til barnet via mælken.
If you are a woman with HIV it is recommended that you do not breast-feed, to avoid passing the virus to the baby in breast milk.
Forekomsten af HIV-serokonvertering samlet set og i den delmængde, som rapporterede ubeskyttet receptivt analt samleje, er vist i Tabel 6.
The incidences of HIV seroconversion overall and in the subset reporting unprotected receptive anal intercourse are shown in Table 6.
Mange HIV-test kan have svært ved at måle en nyligt opstået infektion.
Many HIV tests can miss a recent infection.
Voksne: En tablet om dagen, så vidt muligt sammen med mad.
Adults: one tablet each day, whenever possible with food.
Efter oral administration er tenofovirs eliminationshalveringstid ca. 12 til 18 timer.
Following oral administration, the elimination half-life of tenofovir is approximately 12 to 18 hours.
Data genereret fra samtidig dosering af ledipasvir/sofosbuvir.
Data generated from simultaneous dosing with ledipasvir/sofosbuvir.
Autoimmune sygdomme (når immunsystemet angriber sunde væv i kroppen), kan også opstå, efter at De begynder at tage medicin for at behandle hiv-infektion.
Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after you start taking medicines to treat HIV infection.
Patienter med hereditaer galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption bør ikke indtage dette lægemiddel.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Dette skyldes dels forbedret sundhedstilstand og livsstil og med hensyn til lipider i blodet undertiden selve hiv-medicinen.
This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves.
Hvis De har taget Emtricitabine/Tenofovir disoproxil Krka under Deres graviditet, kan lægen anmode om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
If you have taken Emtricitabine/Tenofovir disoproxil Krka during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Både emtricitabin og tenofovir har aktivitet, som er specifik mod human immundefekt virus (hiv 1 og hiv 2) og hepatitis B-virus.
Both emtricitabine and tenofovir have activity that is specific to human immunodeficiency virus (HIV-1 and HIV-2) and hepatitis B virus.
Relativ risikoreduktion beregnet for hændelsen (post-baseline) serokonvertering fra den dobbeltblinde behandlingsperiode og igennem den otte uger lange opfølgningsperiode.
Relative risk reduction calculated on incident (post-baseline) seroconversion from the double-blind treatment period and through the 8-week follow-up period.
BLISTERE (OPA/Alu/PE+DES-Alu FOLIE)
BLISTER (OPA/Alu/PE+DES-Alu FOIL)
Med hensyn til monitorering af blodlipider og blodglucose henvises til relevante retningslinjer for hiv-behandling.
For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Antal år klar over diskordant status
Years living with study partner Years aware of discordant status
Hold tabletbeholderen tæt tillukket for at beskytte mod fugt og lys.
Keep the bottle tightly closed in order to protect from moisture and light.
→ Hvis De bemærker nogen af de ovenfor anførte bivirkninger, eller hvis nogen af bivirkningerne bliver alvorlige, skal De tale med lægen eller apotekspersonalet.
→ If you notice any of the side effects listed above or if any of the side effects get serious, talk to your doctor or pharmacist.
nyresvigt (akut og kronisk), akut tubulær nekrose, nefritis (herunder akut interstitiel nefritis)
renal failure (acute and chronic), acute tubular necrosis, nephritis (including acute interstitial nephritis)
Grupper med aktiv forsøgsmedicin er sammenlignet med placebo.
Comparisons for active study groups are made versus placebo.
Brug kondom for at reducere kontakten med sæd, vaginalvæsker og blod.
- Always practice safer sex. Use condoms to reduce contact with semen, vaginal fluids, or blood.
Emtricitabins binding in vitro til humane plasmaproteiner var < 4% og uafhængig af koncentrationsområdet på 0,02-200 µg/mL.
In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02 to 200 µg/mL.
forhøjet serum-aspartataminotransferase (ASAT) og/eller forhøjet serum-alanin-aminotransferase (ALAT), hyperbilirubinæmi forhøjede aminotransferaser
elevated serum aspartate aminotransferase (AST) and/or elevated serum alanine aminotransferase (ALT), hyperbilirubinaemia increased transaminases
Hvis samtidig brug af med nefrotoksiske lægemidler ikke kan undgås, bør nyrefunktionen monitoreres ugentligt.
If concomitant use with nephrotoxic agents is unavoidable, renal function should be monitored weekly.