natgillin/translations-raw huggingface dataset:
50016 Zaragoza Spanien 
10000 Zagreb Croatia
Seponer Imatinib Teva indtil ANC ≥ 1,5 x 109/l og trombocytter ≥75 x 10 
Stop imatinib until ANC ≥ 1.5 x 10
Vaskulære sygdomme4 
Vascular disorders4 Common
Startdosis er 100 mg, som skal tages som 1 kapsel én gang daglig. 
The starting dose is 100 mg, to be taken as 1 capsule once a day.
• Kraftige mavesmerter, blod i opkast, afføring eller urin, sortfarvet afføring (tegn på mave-tarm-sygdomme). 
• Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).
Indlægsseddel: Information til brugeren Imatinib Teva 400 mg hårde kapsler imatinib 
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 400 mg hard capsules imatinib
Indlægsseddel: Information til brugeren Imatinib Teva 100 mg filmovertrukne tabletter imatinib 
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 100 mg film-coated tablets imatinib
Indlægsseddel: Information til brugeren Imatinib Teva 400 mg filmovertrukne tabletter imatinib 
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 400 mg film-coated tablets imatinib
Startdosis er 100 mg, som skal tages som 1 tablet én gang daglig. 
The starting dose is 100 mg, to be taken as 1 tablet once a day.
Cytogenetisk hovedrespons2 Fuldstændigt (Bekræftet3) [95% CI] 
Complete (Confirmed3) [95% CI]
Imatinib Teva 100 mg filmovertrukne tabletter 
Imatinib Teva 100 mg film-coated tablets
Indlægsseddel: Information til brugeren Imatinib Teva 100 mg hårde kapsler imatinib 
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 100 mg hard capsules imatinib
I tilfælde af recidiverende ANC <1,0 x 109/l og/eller trombocytter <50 x 109/l, gentag trin 1 og genoptag behandling med Imatinib Teva i en reduceret dosis på 260 mg/m2. 
In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 260 mg/m2.
Imatinib Teva 400 mg filmovertrukne tabletter 
Imatinib Teva 400 mg film-coated tablets
Din læge kan beslutte at øge dosis til 400 mg, som skal tages som 1 tablet á 400 mg én gang daglig afhængig af, hvordan du responderer på behandlingen. 
Your doctor may decide to increase the dose to 400 mg, to be taken as 1 tablet of 400 mg once a day, depending on how you respond to treatment.
= intramuskulær, ARA-C = cytarabin, CPM = cyclophosphamid, VCR = vinkristin, DEX = dexamethason, DAUN = daunorubicin, 6MP = 6-mercaptopurin, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethan-natriumsulfonat, iii= eller indtil MTX-niveauet er <0,1 μM, Gy= Gray 
VCR (1.5 mg/m2/day, IV): days 1, 29 DEX (6 mg/m2/day, PO): days 1-5; 29-33 6-MP (75 mg/m2/day, PO): days 1-56 Methotrexate (20 mg/m2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50 G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG
Din læge kan beslutte at øge dosis til 400 mg, som skal tages som 1 kapsel á 400 mg én gang daglig afhængig af, hvordan du responderer på behandlingen. 
Your doctor may decide to increase the dose to 400 mg, to be taken as 1 capsule of 400 mg once a day, depending on how you respond to treatment.
Tredobbelt i.t.-terapi (aldersjusteret): dag 8, 15 
IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
4.5), CYP3A4 substrater med et snævert terapeutisk vindue (f.eks. ciclosporin, pimozid, tacrolimus, sirolimus, ergotamin, diergotamin, fentanyl, alfentanil, terfenadin, bortezomib, docetaxel, quinidin) eller warfarin og andre coumarin-derivater (se pkt. 
Caution should be used when taking imatinib with protease inhibitors, azole antifungals, certain macrolides, CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) or warfarin and other coumarin derivatives (see section 4.5).
Klassificering af nedsat leverfunktion: Nedsat leverfunktion 
Liver dysfunction classification:
- Hver Imatinib Teva-filmovertrukken tablet indeholder 400 mg imatinib (som mesilat). 
- Each film-coated tablet of Imatinib Teva contains 400 mg imatinib (as mesilate).
I tilfælde af tilbagevenden af ANC <1,0 x 109/l og/eller trombocytter <50 x 109/l, gentages trin 1 og Imatinib Teva reintroduceres med nedsat dosering på 400 mg. 
In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 400 mg.
Hos ca. 2,5% af nyligt diagnosticerede CML-patienter i behandling med imatinib er der rapporteret tilfælde af svær væskeretention (pleuraeksudat, ødem, pulmonært ødem,ascites, perifert ødem). 
Occurrences of severe fluid retention (pleural effusion, oedema, pulmonary oedema, ascites, superficial oedema) have been reported in approximately 2.5% of newly diagnosed CML patients taking imatinib.
CPM (250 mg/m2/dosis q12h x 4 doser, i.v. 
CPM (250 mg/m2/dose q12h x 4 doses, iv): Days 3 and 4 PEG-ASP (2500 IUnits/m2, IM): day 4
Du skal straks fortælle din læge, hvis du meget hurtigt tager på i vægt, mens du er i behandling med Imatinib Teva. 
During treatment with Imatinib Teva, tell your doctor straight away if you put on weight very quickly.
I tilfælde af recidiverende ANC <1,0 x 109/l og/eller trombocytter <50 x 109/l, gentag trin 1 og genoptag behandling med Imatinib Teva i en reduceret dosis på 300 mg. 
In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 300 mg.
Det skal du vide, før du begynder at tage Imatinib Teva Sådan skal tage Imatinib Teva Bivirkninger 
What you need to know before you take Imatinib Teva 3.
Af en række potentielt samtidigt administrerede lægemidler (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabin, erythromycin, fluconazol, hydroxyurea, norfloxacin, phenoxymethylpenicillin) hæmmede kun erythromycin (IC50 50 μm) og fluconazol (IC50 118 μm) imatinib-metabolismen i et omfang, der kunne have klinisk betydning. 
Of a panel of potential comedications (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin,
- Hvis du behandles for Ph-positiv ALL: Startdosis er 600 mg, som skal tages som 1kapsel á 400 mg og 2 kapsler á 100 mg én gang daglig. 
- If you are being treated for CML: Depending on your condition the usual starting dose is either 400 mg or 600 mg: 400 mg to be taken as 1 capsule once a day, 600 mg to be taken as 1 capsule of 400 mg plus 2 capsules of 100 mg once a day.
Brystsmerter, utilpashed 
Hepatic insufficiency
): dag 43, 44 
(1 h), days 26, 46;
): dag 1, 8, og 15 
(0.5 h), days 7, 8, 14, 15;
LISTE OVER HJÆLPESTOFFER LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) 
PHARMACEUTICAL FORM AND CONTENTS
(3 timer, q 12 timer), dag 1-3; vinkristin 2 mg i.v., dag 4, 11; doxorubicin 50 mg/m2 i.v. 
Vincristine 2 mg i.v., days 4, 11; Doxorubicine 50 mg/m2 i.v.
- Hver Imatinib Teva filmovertrukken tablet indeholder 100 mg imatinib (som mesilat). 
- Each film-coated tablet of Imatinib Teva contains 100 mg imatinib (as mesilate).
BN22 9AG Storbritannien 
България Актавис ЕАД
- Hver kapsel indeholder 100 mg imatinib (som mesilat). 
- Each hard capsule of Imatinib Teva contains 100 mg imatinib (as mesilate).
Andre bivirkninger kan omfatte: Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter): 
Very common (may affect more than 1 in 10 people):
DEX 10 mg/m2 oral, dag 1-5; VCR 2 mg i.v., 
DEX 10 mg/m2 oral, days 1-5;
28; MTX 15 mg intrathecal, dag 1, 8, 15, 22; Ara-C 40 mg intrathecal, dag 1, 8, 15, 22; methylprednisolon 40 mg intrathecal, dag 1, 
MTX 15 mg intrathecal, days 1, 8, 15, 22;
Tredobbelt i.t.-terapi (aldersjusteret): dag 1, 29 
Triple IT therapy (age-adjusted): days 1, 29 VCR (1.5 mg/m2, IV): days 1, 29
Leversvigt8, levernekrose 
Printing ink Shellac
timer), dag 5 
(24 h), day 4;
CHR rate n (%) [95% CI] 
Partial CyR n (%)
Mave-tarm-kanalen 
Capsule content Mannitol
): dag 1-5 G-CSF (5 μg/kg, s.c.): dag 6-15, eller indtil ANC > 1500 post nadir I.t. 
MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5 G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir
Tabletkerne: 
Tablet coat
Methotrexate (5 g/m2 over 24 hours, IV): days 1 and 15 
VCR (1.5 mg/m2/day, IV): days 1, 8 and 15
VCR (1,5 mg/m2/dag, i.v. 
VCR (1.5 mg/m2/day, IV): days 1, 8, and 15
Blod og lymfesystem 
Anaphylactic shock* Blood and lymphatic system disorders Very common
Hver filmovertrukken tablet indeholder 100 mg imatinib (som mesilat). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Pakningsstørrelser og yderligere oplysninger Imatinib Teva indeholder: 
Contents of the pack and other information What Imatinib Teva contains - The active substance is imatinib (as mesilate).
Hver kapsel indeholder 400 mg imatinib (som mesilat). 
- Each hard capsule of Imatinib Teva contains 400 mg imatinib (as mesilate).
eller p.o. q6h x 6 doses)iii: dag 2 og 3 
doses)iii: days 2 and 3
2-3, i 4 cyklus 
(q 12 h), days 2-3, for 4 cycles
Imatinib Teva 100 mg filmovertrukne tabletter Imatinib Teva 400 mg filmovertrukne tabletter 
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 100 mg film-coated tablets Imatinib Teva 400 mg film-coated tablets
Hver filmovertrukken tablet indeholder 400 mg imatinib (som mesilat). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 400 mg of imatinib (as mesilate).
Dette sammendrag blev sidst ajourført den 22/04/2013. 
This summary was last updated on 22/04/2013.
I meget sjældne tilfælde kan bivirkningerne være alvorlige eller dødelige. 
In very rare cases they may be serious or fatal.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Meloxidolor den 22/04/2013. 
The European Commission granted a marketing authorisation valid throughout the European Union, for Meloxidolor on 22/04/2013.
Det må ikke anvendes til katte, der vejer under 2 kg. 
It must not be used in cats weighing less than 2 kg.
Hos hunde optræder bivirkningerne normalt i den første uge af behandlingen og svinder sædvanligvis, når behandlingen ophører. 
In dogs, these generally occur within the first week of treatment and usually disappear once treatment has stopped.
Produktet bør ikke anvendes til heste, der producerer mælk til konsum. 
The product is not authorised for use in horses producing milk for human consumption.
Personer, som er overfølsomme (allergiske) over for NSAID, bør undgå kontakt med Meloxidolor. 
People who are hypersensitive (allergic) to NSAIDs should avoid contact with Meloxidolor.
Det må ikke anvendes hos dyr, der er overfølsomme (allergiske) over for det aktive stof eller andre af indholdsstofferne. 
It must not be used in animals which are hypersensitive (allergic) to the active substance or to any of the other ingredients.
CVMP var derfor af den opfattelse, at fordelene ved Meloxidolor ligesom ved Metacam er større end risiciene, når det anvendes til de godkendte indikationer, og anbefalede udstedelse af markedsføringstilladelse for Meloxidolor. 
Therefore the CVMP's view was that, as for Metacam, Meloxidolor's benefits are greater than its risks when used for the approved indications and the Committee recommended that Meloxidolor be given a marketing authorisation.
Andre oplysninger om Meloxidolor: 
Other information about Meloxidolor:
Meloxidolor er et lægemiddel, der indeholder det aktive stof meloxicam. 
Meloxidolor is a medicine that contains the active substance meloxicam.
Tilbageholdelsestiden er den tid, der skal gå efter lægemidlets indgivelse, før dyret kan slagtes, og kødet kan anvendes til konsum. 
The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat used for human consumption.
Forholdet mellem fordele og risici fremgår af afsnittet med den videnskabelige drøftelse i denne EPAR. 
The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Udvalget for Lægemidler til Dyr (CVMP) vurderede, at det i overensstemmelse med EU-kravene er blevet påvist, at Meloxidolor er bioækvivalent med Metacam. 
The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Meloxidolor has been considered to be bioequivalent to Metacam.
Det vil sige, at det svarer til et veterinært “referencelægemiddel”, der indeholder samme aktive stof, men det fås også i en højere styrke. 
This means that Meloxidolor is similar to a ‘reference veterinary medicine' containing the same active substance, but it is also available at a higher strength.
Meloxidolor indeholder meloxicam, som tilhører lægemiddelgruppen ikke-steroide antiinflammatoriske lægemidler (NSAID). 
Meloxidolor contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Til intravenøs anvendelse var det ikke nødvendigt med undersøgelser hos dyr, da Meloxidolor indeholder det samme aktive stof som referencelægemidlet Metacam. 
For intravenous use no studies in animals were needed as Meloxidolor contains the same active substance as the reference medicine Metacam.
Meloxicam virker ved at blokere enzymet cyclooxygenase, der medvirker ved produktionen af prostaglandiner. 
Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
Da Meloxidolor anses for bioækvivalent med referencelægemidlet, forventes det at have de samme fordele som referencelægemidlet. 
As Meloxidolor is considered to be bioequivalent to the reference medicine, its benefit is taken as being the same as that of the reference medicine.
Hos heste kan der på injektionsstedet forekomme midlertidig hævelse, som svinder uden behandling. 
In horses, a temporary swelling at the injection site can occur but resolves without intervention.
Meloxidolor er et “generisk lægemiddel”. 
Meloxidolor is a 'generic'.
Det er desuden den tid, der skal gå, efter at dyret har fået lægemidlet, før mælken kan anvendes til konsum. 
It is also the time allowed after administration of the medicine before the milk can be used for human consumption.
Meloxidolor bør ikke indgives af kvinder, der er gravide eller muligvis er gravide, da meloxicam kan være skadeligt for fosteret og det ufødte barn. 
Pregnant women and women of child-bearing potential should not administer Meloxidolor as meloxicam may be harmful for the foetus and unborn child.
Det leveres som en injektionsvæske, opløsning (5 mg/ml, 20 mg/ml og 40 mg/ml). 
It is available as a solution for injection (5 mg/ml, 20 mg/ml and 40 mg/ml).
Til subkutan og intramuskulær anvendelse var det ikke nødvendigt med undersøgelser vedrørende styrkerne 5 mg/ml og 20 mg/ml, da de indeholder samme koncentration af det aktive stof og har tilsvarende sammensætning som referenceproduktet Metacam. 
For subcutaneous and intramuscular use no studies were need for the 5 mg/ml and 20 mg/ml strengths as they contain the same concentration of active substance and have a similar composition to the reference product Metacam.
Hvilken risiko er der forbundet med Meloxidolor? 
What is the risk associated with Meloxidolor?
Det kan sammen med oral rehydreringsbehandling anvendes til behandling af diarré hos kalve over en uge gamle og hos ungkvæg, der ikke er diegivende. 
It can be used in combination with oral re-hydration therapy for diarrhoea (medicines given by mouth to restore water levels in the body) in calves of over one week of age and in young, non-lactating cattle.
Meloxidolor bør ikke anvendes til drægtige eller diegivende hunde, katte eller heste, men hos kvæg og svin kan det anvendes under drægtighed og diegivning. 
Meloxidolor should not be used in pregnant or lactating dogs, cats and horses, but it can be used during pregnancy and lactation for cattle and pigs.
Meloxidolor må ikke anvendes til hunde, katte eller heste, der er under seks uger gamle, eller til behandling af diarré hos kvæg, der er under en uge gamle. 
Meloxidolor must not be used in dogs, in cats or horses less than six weeks of age, in cattle less than one week of age when used in the treatment of diarrhoea or in pigs less than two days old.
Hvorfor blev Meloxidolor godkendt? 
Why has Meloxidolor been approved?
I meget sjældne tilfælde kan der optræde anafylaktoide reaktioner (svarende til svær allergi) efter indgift af injektionsvæsken. 
In very rare cases, potentially serious or fatal anaphylactoid reactions (similar to severe allergic reactions) may occur following administration of the solution for injection and should be treated symptomatically.
Meloxidolor må ikke anvendes til dyr med lever-, hjerte- eller nyrelidelser, blødningsforstyrrelser eller irritation eller sår i mave-tarmkanalen. 
Meloxidolor must not be used in animals with liver, heart or kidney problems, bleeding disorders, or suffering from irritation or ulcers of the digestive tract.
Da prostaglandiner er stoffer, der udløser irritation af vævet, smerte, væskeudskillelse og feber, mindsker meloxicam disse reaktioner. 
As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Efter injektion under huden hos kvæg og svin sås en midlertidig let hævelse på injektionsstedet. 
A slight temporary swelling at the injection site following injection under the skin was observed in cattle and pigs.
Hvad er Meloxidolor? 
What is Meloxidolor?
Hvad anvendes Meloxidolor til? 
What is Meloxidolor used for?
Hvordan blev Meloxidolor undersøgt? 
How has Meloxidolor been studied?
Injektionsvæsken i styrkerne 20 mg/ml og 40 mg/ml anvendes desuden i kombination med antibiotika til behandling af akut mastitis (yverbetændelse). 
The 20 mg/ml and 40/mg/ml solutions for injection are also used in combination with antibiotic therapy to treat acute mastitis (inflammation of the udder).
Referencelægemidlet Metacam leveres som injektionsvæske i styrkerne 5 mg/ml og 20 mg/ml, mens Meloxidolor også leveres som injektionsvæske i styrken 40 mg/ml. 
While the reference medicine, Metacam, is available as 5 mg/ml and 20 mg/ml solutions for injection, Meloxidolor is also available as a 40 mg/ml solution for injection.
Meloxidolor, injektionsvæske, opløsning, 5 mg/ml, kan anvendes til lindring af betændelse og smerter hos hunde efter operationer på knoglerne og hudens underliggende væv samt hos katte efter ovariohysterektomi (sterilisering) og mindre bløddelsoperationer. 
Meloxidolor solution for injection (5 mg/ml) can be used to relieve inflammation and pain in dogs following surgery involving the bones or soft tissue (tissue just below the skin), and in cats following ovariohysterectomy (spaying) and minor soft tissue surgery.
Meloxidolor, injektionsvæske, opløsning (20 mg/ml og 40 mg/ml) anvendes hos heste til lindring af kolik (mavesmerter) og inflammation og smerter ved lidelser i bevægeapparatet. 
Meloxidolor solution for injection (20 mg/ml and 40 mg/ml) is used in horses to relieve colic (abdominal pain) and the inflammation and pain in musculo-skeletal disorders.
Meloxidolor, injektionsvæske, opløsning (5 mg/ml, 20 mg/ml og 40 mg/ml) anvendes til kvæg sammen med passende antibiotisk behandling til mindskelse af sygdomstegn ved akutte luftvejsinfektioner. 
Meloxidolor solution for injection (5 mg/ml, 20 mg/ml and 40 mg/ml) is used in cattle, together with appropriate antibiotic therapy, to reduce signs of disease in acute respiratory infections (infection of the lungs and airways).
Hvilken fordel viser undersøgelserne, at der er ved Meloxidolor? 
What benefit has Meloxidolor shown during the studies?
Injektionsvæsken i styrken 20 mg/ml kan sammen med passende antibiotisk behandling anvendes til sygdomme efter faring (fødsel) såsom puerperal septikæmi (bakterier i blodet) og toksæmi (en forgiftningstilstand) (mastitis-metritisagalakti-syndrom). 
The 5 mg/ml solution for injection can also be used for the relief of post-operative pain associated with minor soft tissue surgery such as castration (surgical removal of the testicles) and the 20 mg/ml solution for injection can be used together with appropriate antibiotic therapy for the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia (bacteria present in blood) and toxaemia (a toxic state) (mastitis-metritis-agalactia syndrome).
Hos hunde og katte medfører Meloxidolor lejlighedsvis bivirkninger svarende til andre NSAID, dvs. appetitløshed, opkastning, diarré, synligt blod i afføringen, nyresvigt og sløvhed. 
Side effects sometimes seen with other NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools, renal (kidney) failure and apathy (lack of vitality) are occasionally seen with Meloxidolor in dogs and cats.
Hvordan virker Meloxidolor? 
How does Meloxidolor work?
Meloxidolor, injektionsvæske, opløsning, 5 mg/ml og 20 mg/ml, anvendes hos svin til lindring af symptomer på halten og inflammation ved ikke-smitsomme sygdomme i bevægeapparatet. 
Meloxidolor solution for injection (5 mg/ml and 20 mg/ml) is used in pigs to reduce the symptoms of lameness (inability to walk normally) and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move).
− Tørst og øget vandforbrug 
− thirst and increased water consumption
Ikke kendt (hyppigheden kan ikke vurderes udfra forhåndenværende data) 
Not known (frequency cannot be estimated from the available data)
Du skal omgående kontakte din læge, hvis du mærker nogen af følgende bivirkninger: 
You must contact your doctor immediately if you notice any of the following:
− hvis du for nylig er blevet eller snart skal vaccineres mod gul feber. 
− if you have recently received or are about to receive a vaccine against yellow fever.
Da der ikke foreligger andre studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler. 
In the absence of other compatibility studies this medicinal product must not be mixed with other medicinal products.
PFS data blev delvist bekræftet af en uafhængig undersøgelse (400/1.725 patienter blev randomiseret og udvalgt til undersøgelsen). 
PFS data were partially confirmed by an independent review (400/1,725 patients were randomly selected for review).
Der findes mange slags NSAIDpræparater med forskellig varighed af det aktive stof. 
There are many sorts of NSAIDs with different durations of activity.
• P-værdi for non-inferioritet (HR) Progressionsfri overlevelse (måneder) 
• Non-inferiority p-value (HR) Progression free survival (months)
Dato for første markedsføringstilladelse: 27 november 2015 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 November 2015
< 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
< 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000) and not known (cannot be estimated from available data).
Din læge vil sammen med dig drøfte den potentielle risiko ved at tage Pemetrexed medac under graviditet. 
Your doctor will discuss with you the potential risk of taking Pemetrexed medac during pregnancy.
Der blev ikke set statistisk signifikante forskelle i andre individuelle grad 3/4/5-bivirkninger ved længere eksponering. 
No statistically significant differences in any other individual Grade 3/4/5 adverse reactions were seen with longer exposure.
Tid til behandlingssvigt (TTTF - måneder) 
Time to treatment failure (TTTF - months)
Overlevelsestid (måneder) 
Survival Time (months)
− Øget urinproduktion 
− increased urine output
Ud fra den planlagte dato for din infusion af Pemetrexed medac og/eller status for din nyrefunktion skal din læge fortælle dig, hvilke typer medicin du må tage, og hvornår du må tage dem. 
Based on the planned date of your infusion of Pemetrexed medac and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
− Anafylaktisk shock (alvorlig allergisk reaktion) 
− anaphylactic shock (severe allergic reaction)