natgillin/translations-raw huggingface dataset:
Målt fra starttidspunktet for pemetrexed plus cisplatin førstelinje-induktionsbehandling var den mediane overlevelse 16,9 måneder for pemetrexed-armen og 14,0 måneder for placebo-armen (hazard ratio= 0,78, 95 % CI= 0,64-0,96).
From the start of pemetrexed plus cisplatin first line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio=0.78, 95 % CI=0.64-0.96).
Armisarte 25 mg/ml Koncentrat, sterilt pemetrexedum i.v.
Armisarte 25 mg/ml sterile concentrate pemetrexed
Mænd rådes til ikke at gøre en kvinde gravid hverken under eller i op til 6 måneder efter behandlingen med Armisarte.
Men are advised not to father a child during and up to 6 months following treatment with Armisarte and should therefore use effective contraception during treatment with Armisarte and for up to 6 months afterwards.
50 % af tidligere dosis
50% of previous dose a
Ikke almindelig (forekommer hos op til 1 ud af 100 patienter) - Akut nyresvigt - Hurtig ler uregelmæssig puls - Betændelse i spiserørets overflade er forekommet med pemetrexed i kombination med strålebehandling.
Uncommon (may affect up to 1 in 100 people) - Acute renal failure - Fast or irregular heart rate - Inflammation of the lining of the oesophagus (gullet) has been experienced with pemetrexed/
Tabel 1 - Dosisjustering for pemetrexed (som enkeltstof eller i kombination) og cisplatinhæmatologisk toksicitet
Table 1 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin - Haematologic toxicities
Tabel 2 - Dosisjustering for pemetrexed (som enkeltstof eller i kombination) og cisplatinikke-hæmatologisk toksicitet a, b
Table 2 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin- Non-haematologic toxicitiesa,b
For patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller (n = 430), uafhængig overvåget population) var middel PFS 4,4 måneder for pemetrexed-delen og 1,8 måneder for placebodelen, hazard ratio = 0,47, 95% CI = 0,37-0,60; p=0,00001.
For patients with NSCLC other than predominantly squamous cell histology (n=430, independently reviewed population) median PFS was 4.4 months for the pemetrexed arm and 1.8 months for the placebo arm, hazard ratio=0.47 (95% CI=0.37-0.60, p=0.00001).
- Allergisk reaktion: Hvis De udvikler udslæt (meget almindelig)/en brændende eller prikkende fornemmelse (almindelig) eller feber (almindelig).
Infection (sepsis) may be severe and could lead to death - If you start feeling chest pain (common) or having a fast heart rate (uncommon) - If you have pain, redness, swelling or sores in your mouth (very common) - Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common).
Incidensen af bivirkninger blev evalueret for de patienter, som fik ≤6 serier af pemetrexed vedligeholdelsesbehandling (N=519), og sammenlignet med de patienter, som fik >6 serierpemetrexed (N=281).
(N=519), and compared to patients who received > 6 cycles of pemetrexed (N=281).
Cytotoksisk stof.
Cytotoxic
Den anbefalede dosis af pemetrexed er 500 mg/m2 legemesoverflade indgivet som intravenøs infusion over 10 minutter på den første dag i hver 21-dages-serie.
Pemetrexed in combination with cisplatin The recommended dose of pemetrexed is 500 mg/m2 of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Pemetrexed er indiceret til behandling sammen med cisplatin, som 1. linje-behandling til patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer, bortset fra cancer hovedsageligt bestående af pladeepitelceller (se pkt.
Pemetrexed in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Pemetrexed er indiceret som 2. linjes monoterapi til behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer, bortset fra cancer hovedsageligt bestående af pladeepitelceller (se pkt.
Pemetrexed is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Tabel 3 - Dosisjustering for pemetrexed (som enkeltstof eller i kombination) og cisplatinneurotoksicitet
Table 3 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin - Neurotoxicity
- Betændelse i huden, hovedsagligt i underbenet med hævelse, smerte og rødme - Øget urinproduktion - Tørst og øget vandforbrug - Øget koncentration af natrium i blodet (hypernatriæmi)
Not known (frequency cannot be estimated from the available data) - Lower limb swelling with pain and redness - Inflammation of the skin, mainly of the lower limb with swelling, pain and redness - Increased urine output - Thirst and increased water consumption - Hypernatraemia - increased sodium in blood
Armisarte 25 mg/ml koncentrat til infusionsvæske, opløsning pemetrexed
Armisarte 25 mg/ml concentrate for solution for infusion pemetrexed
Ved at inkludere induktionsfasen blev middel OS for patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller 18,6 måneder for pemetrexed-delen og 13,6 måneder for placebodelen (hazard ratio=0,71, 95% CI = 0,56 - 0,88, p=0,002).
Including the induction phase the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio=0.71 (95 % CI=0.56-0.88, p=0.002).
Bivirkningerne blev rapporteret hos > 5 % af de 800 patienter, som var randomiseret til enkeltstofbehandling med pemetrexed, og de 402 patienter, som var randomiseret til placebo i studiet med pemetrexed vedligeholdelsesbehandling (JMEN: N=663) og studiet med pemetrexed induktionsbehandling efterfulgt af pemetrexed vedligeholdelsesbehandling (PARAMOUNT: N=539).
The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5 % of 800 patients randomly assigned to receive single agent pemetrexed and 402 patients randomly assigned to receive placebo in the single-agent pemetrexed maintenance (JMEN: N=663) and continuation pemetrexed maintenance (PARAMOUNT: N=539) studies.
- Hvis De bløder fra gummer, næse eller mund eller anden blødning, som ikke vil stoppe, rødlig eller lyserødlig urin, uventede blå mærker (fordi De muligvis har færre blodplader end normalt, hvilket er meget almindeligt).
Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis) - If you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common) - If you experience bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common) - If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (uncommon)(may indicate a blood clot in the blood vessels of the lungs)
Den gennemsnitlige OS for patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller (n = 481) var 15,5 måneder for pemetrexed-delen og 10,3 måneder for placeboarmen (hazard ratio = 0,70, 95% CI = 0,56 - 0,88, p = 0,002).
The median OS for patients with NSCLC other than predominantly squamous cell histology (n=481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio=0.70 (95 % CI = 0.56-0.88, p = 0.002).
- Ødemer (væskeophobning i væv, som medfører hævelse) - Nogle patienter har oplevet et hjertetilfælde, et slagtilfælde eller et ”mini-slagtilfælde”, mens de har fået pemetrexed, sædvanligvis i kombination med anden kræftbehandling.
radiation therapy - Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding) - Interstitial pneumonitis (scarring of the air sacs of the lung) - Oedema (excess fluid in body tissue, causing swelling) - Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving pemetrexed usually in combination with another anticancer therapy - Pancytopenia- combined low counts of white cells, red cells and platelets - Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy)
Kvamle
Stomatitis/
100 % af tidligere dosis a National Cancer Institute Common Toxicity Criteria (CTC v 2.0; NCI 1998) b Undtagen neurotoksicitet
National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Forsigtighedsregler i forbindelse med forberedelse og indgivelse
Preparation and administration precautions
- Smerter i arme og ben, lav temperatur og misfarvning er indberettet - Blodpropper i lungernes blodårer (lungeemboli)
may occur in patients who are also treated with radiation before, during or after their pemetrexed therapy - Extremity pain, low temperature and discolouration have been reported - Blood clots in the lung blood vessels (pulmonary embolism)
Et 34 ml hætteglas indeholder 850 mg pemetrexed (som pemetrexeddiacid).
One vial of 34 ml contains 850 mg pemetrexed (as pemetrexed diacid).
Dosis er baseret på Deres højde og vægt (som anvendes til beregning af legemsoverfladearealet), idet der indgives, hvad der svarer til 500 mg Armisarte per kvadratmeter legemsoverflade.
The dose of Armisarte is 500 milligrams for every square metre of your body's surface area.
Et 40 ml hætteglas indeholder 1000 mg pemetrexed (som pemetrexeddiacid).
One vial of 40 ml contains 1000 mg pemetrexed (as pemetrexed diacid).
Median (m) 95 %-CI for median
Survival Time (months) Median (m) 95 % CI for median HR 95 % CI for HR Non-inferiority p-value (HR)
Et 4 ml hætteglas indeholder 100 mg pemetrexed (som pemetrexeddiacid).
One vial of 4 ml contains 100 mg pemetrexed (as pemetrexed diacid).
Et 20 ml hætteglas indeholder 500 mg pemetrexed (som pemetrexeddiacid).
One vial of 20 ml contains 500 mg pemetrexed (as pemetrexed diacid).
1 ml koncentrat indeholder 25 mg pemetrexed (som pemetrexeddiacid).
One ml of concentrate contains 25 mg pemetrexed (as pemetrexed diacid).
1 ml indeholder 25 mg pemetrexed (som pemetrexeddiacid).
One ml contains 25 mg pemetrexed (as pemetrexed diacid).
Et multi-center, randomiseret, dobbeltblindet, placebokontrolleret fase 3-studie (PARAMOUNT) sammenlignede virkningen og sikkerheden af fortsat vedligeholdelsesbehandling med pemetrexed plus bedste understøttende pleje (BSC, Best Supportive Care) (n=359) med placebo plus BSC (n=180) hos
A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (PARAMOUNT), compared the efficacy and safety of continuation maintenance treatment with pemetrexed plus BSC (n=359) with that of placebo plus BSC (n=180) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC other than predominantly squamous cell histology who did not progress after 4 cycles of first line doublet therapy of pemetrexed in combination with cisplatin.
Det skal De vide, før De begynder at bruge Armisarte Sådan skal De bruge Armisarte Bivirkninger
What Armisarte is and what it is used for What you need to know before you use Armisarte How to use Armisarte
Det er ikke relevant at bruge Armisarte til børn og teenagere.
There is no relevant use of Armisarte in the paediatric population
Nedsat hæmoglobin Almindelig Nedsat trombocytter
Common Leukocytes decreased
(n = 222)
Cisplatin (N=222)
Patienter med nedsat leverfunktion
Patient with hepatic impairment
Den 14. maj 2013
14 May 2013
CHMP bekræftede ovenstående konklusioner efter fornyet gennemgang af sin udtalelse.
The CHMP confirmed the above conclusions after re-examining its opinion.
Efter fornyet gennemgang bekræftede udvalget disse anbefalinger den 18. februar 2013.
After re-examination, the Committee confirmed these recommendations on 18 February 2013.
Europa-Kommissionen traf en afgørelse den 14. maj 2013.
The European Commission issued a decision on 14 May 2013.
Det skulle have været leveret som tabletter (40 mg).
It was to be available as tablets (40 mg).
Det virker i nyrerne ved at øge urinproduktionen, nedsætte blodets væskeindhold og sænke blodtrykket.
It works in the kidneys by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.
Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den polske lægemiddelstyrelse indbragte sagen for CHMP med henblik på voldgift den 30. maj 2011.
However, the Member States were not able to reach an agreement and the Polish medicines regulatory agency referred the matter to the CHMP for arbitration on 30 May 2011.
Den 18. oktober 2012 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) vedrørende godkendelsen af lægemidlet Furosemid Vitabalans.
On 18 October 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Furosemide Vitabalans.
Ved denne procedure vurderer én medlemsstat (“referencemedlemsstaten”, her Estland) et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, der er gyldig i det pågældende land foruden i andre medlemsstater (de “berørte medlemsstater”, her Danmark, Finland, Letland, Litauen, Polen, Slovakiet, Slovenien, Sverige, Tjekkiet og Ungarn, samt Norge.
This is a procedure where one Member State (the ‘reference Member State', in this instance Estonia) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Czech Republic, Denmark, Finland, Hungary, Latvia, Lithuania, Norway, Poland, Slovakia, Slovenia and Sweden).
• let til moderat hypertension (forhøjet blodtryk).
• mild to moderate hypertension (high blood pressure).
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Furosemid Vitabalans ikke opvejer risiciene, og at der ikke kan udstedes markedsføringstilladelse i Estland og i følgende EU-medlemsstater: Danmark, Finland, Letland, Litauen, Polen, Slovakiet, Slovenien, Sverige, Tjekkiet og Ungarn, samt Norge.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Furosemide Vitabalans do not outweigh its risks, and the marketing authorisation cannot be granted in Estonia and in the following Member States of the EU: Czech Republic, Denmark, Finland, Hungary, Latvia, Lithuania, Poland, Slovakia, Slovenia and Sweden, as well as Norway.
Spørgsmål og svar om Furosemid Vitabalans (tabletter, 40 mg)
Questions and answers on Furosemide Vitabalans (tablet, 40 mg)
Spørgsmål og svar om Furosemid Vitabalans (tabletter, 40 mg) EMA/107842/2013
Questions and answers on Furosemide Vitabalans (tablet, 40 mg) EMA/423459/2013
• levercirrose (skrumpelever) og nyresygdom, herunder nefrotisk syndrom
• cirrhosis of the liver (a type of liver disease) and renal disease, including nephrotic syndrome;
Det var hensigten, at Furosemid Vitabalans skulle anvendes til behandling af følgende:
Furosemide Vitabalans was intended to be used to treat the following conditions:
Ansøgningen blev dokumenteret med publiceret litteratur fremfor undersøgelser udført med Furosemid Vitabalans, fordi furosemid har haft almindeligt anerkendt anvendelse i EU i mindst ti år.
The application was supported by published literature rather than studies carried out with Furosemide Vitabalans, because furosemide has a history of well-established use in the EU for at least 10 years.
Furosemid Vitabalans er et lægemiddel, der indeholder det aktive stof furosemid.
Furosemide Vitabalans is a medicine that contains the active substance furosemide.
Hvad er Furosemid Vitabalans?
What is Furosemide Vitabalans?
Vitabalans Oy ansøgte om godkendelse af Furosemid Vitabalans hos den estiske lægemiddelstyrelse ved en decentral procedure.
Vitabalans Oy submitted an application for Furosemide Vitabalans to the Estonian medicines regulatory agency for a decentralised procedure.
CHMP konkluderede, at benefit/risk-forholdet for Furosemid Vitabalans ikke kunne fastlægges, og at der derfor ikke burde udstedes markedsføringstilladelse for Furosemid Vitabalans i nogen af de berørte medlemsstater.
The CHMP concluded that the balance of the benefits and risks of Furosemide Vitabalans could not be established, and therefore the marketing authorisation for Furosemide Vitabalans should not be granted in all concerned Member States.
Hvorfor blev Furosemid Vitabalans vurderet igen?
Why was Furosemide Vitabalans reviewed?
Det aktive stof i Furosemid Vitabalans, furosemid, tilhører en gruppe lægemidler, der kaldes diuretika.
The active substance in Furosemide Vitabalans, furosemide, belongs to a group of medicines known as diuretics.
Den polske og den litauiske lægemiddelstyrelse var af den opfattelse, at de data, der er forelagt som dokumentation for ansøgningen, ikke gav tilstrækkeligt bevis for sikkerheden og virkningen af Furosemid Vitabalans.
The Polish and Lithuanian agencies were of the opinion that the data submitted to support the application did not provide sufficient evidence to demonstrate the safety and effectiveness of Furosemide Vitabalans.
Efter vurderingen af de foreliggende data og den videnskabelige drøftelse i udvalget fandt CHMP, at de indsendte oplysninger ikke var tilstrækkelige til at vise, at Furosemid Vitabalans kunne anvendes sikkert og effektivt på grundlag af den almindeligt anerkendte anvendelse af furosemid.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the data submitted were not sufficient to show that Furosemide Vitabalans could be used safely and effectively based on the well established use of furosemide.
Begrundelsen for indbringelsen var, at de oplysninger fra litteraturen, der var forelagt som dokumentation for ansøgningen, ikke kunne anvendes på Furosemid Vitabalans, og at de forelagte oplysninger til “brobygning” ikke blev anset for tilstrækkelige til at drage konklusioner om benefit/riskforholdet for Furosemid Vitabalans.
The grounds for the referral were that the data from the literature submitted to support this application could not be applied to Furosemide Vitabalans and the bridging data provided were not considered adequate to conclude on the benefit-risk profile of Furosemide Vitabalans.
• ødem (hævelse) ved kongestivt hjertesvigt med væskeophobning
• oedema (swelling) associated with congestive heart failure (a type of heart disease);
Resultaterne af de tre studier efter 12 ugers behandling er som følger:
The results of the three studies after 12 weeks of treatment are as follows:
Olumiant fik en markedsføringstilladelse med gyldighed i hele EU den 13. februar 2017.
Olumiant received a marketing authorisation valid throughout the EU on 13 February 2017.
Den sædvanlige dosis er 4 mg én gang dagligt, men den kan nedsættes til 2 mg én gang dagligt, når sygdommen er under kontrol.
The usual dose is 4 mg once a day but this can be reduced to 2 mg once a day when the disease is under control.
Olumiant må ikke anvendes under graviditet.
Olumiant must not be used during pregnancy.
Yderligere information om Olumiant findes på agenturets websted under: ema.europa.eu/en/medicines/human/EPAR/olumiant.
Further information on Olumiant can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/olumiant.
Patienterne skal have udleveret et særligt informationskort, der sammenfatter sikkerhedsoplysningerne om lægemidlet.
Patients will be given a special alert card that summarises the safety information about the medicine.
Andre oplysninger om Olumiant
Other information about Olumiant
Der mangler dog langtidssikkerhedsdata, og derfor er disse resultater i sig selv ikke tilstrækkelige til at underbygge brugen af Olumiant hos tidligere ubehandlede patienter.
However, long-term safety data are missing and these results alone are therefore not sufficient to support Olumiant use in previously untreated patients.
I et studie, der omfattede 584 patienter, var Olumiant mere effektivt end methotrexat.
In one study involving 584 patients, Olumiant was more effective than methotrexate.
Olumiant er også blevet undersøgt hos patienter, som ikke tidligere har modtaget behandling.
Olumiant has also been studied in patients who had not received previous treatment.
Som for alle lægemidler bliver data vedrørende brug af Olumiant løbende overvåget.
As for all medicines, data on the use of Olumiant is continuously monitored.
Det virker ved at blokere aktiviteten af enzymer, der kaldes Janus-kinaser.
It works by blocking the action of enzymes known as Janus kinases.
Alt i alt betragtes lægemidlets bivirkninger som overskuelige, og der er truffet adskillige foranstaltninger for at minimere risiciene ved dette lægemiddel, navnlig infektion.
Overall, its side effects are considered manageable and several measures have been put in place to minimise the risks with this medicine, particularly infection.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Olumiant?
What measures are being taken to ensure the safe and effective use of Olumiant?
For mere information om brug af Olumiant, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
For more information about using Olumiant, see the package leaflet or contact your doctor or pharmacist.
Ved at blokere enzymerne mindsker baricitinib betændelsen og andre symptomer på sygdommen.
By blocking the enzymes, baricitinib reduces the inflammation and other symptoms of the disease.
Hvad er Olumiant, og hvad anvendes det til?
What is Olumiant and what is it used for?
Hvorfor er Olumiant godkendt i EU?
Why is Olumiant authorised in the EU?
Det kan ligeledes være nødvendigt at nedsætte dosis hos patienter med nedsat nyrefunktion, patienter med øget risiko for infektioner og hos patienter over 75 år, eller hos patienter, der tager visse andre lægemidler.
The dose may also need to be reduced in patients who have impaired kidney function, who have an increased risk of infections and in those aged over 75 years or who are taking certain other medicines.
Bivirkninger rapporteret for Olumiant vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Olumiant are carefully evaluated and any necessary action taken to protect patients.
En oversigt over Olumiant, og hvorfor det er godkendt i EU
An overview of Olumiant and why it is authorised in the EU
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Olumiant opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency decided that Olumiant's benefits are greater than its risks and it can be authorised for use in the EU.
Behandling med Olumiant skal indledes af en læge med erfaring i diagnosticering og behandling af rheumatoid arthritis.
Treatment with Olumiant must be started by a doctor who has experience in the diagnosis and treatment of rheumatoid arthritis.
De hyppigste bivirkninger ved Olumiant anvendt alene eller i kombination med methotrexat var øgede kolesterolniveauer i blodet, næse- og halsinfektioner samt kvalme (som kan forekomme hos mere end 2 ud af 100 patienter).
The most common side effects with Olumiant used alone or in combination with methotrexate were increased blood cholesterol levels, nose and throat infections and nausea (which may affect 2 or more people in 100).