FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Imatinib Teva 400 mg hard capsules imatinib
Danish: Indlægsseddel: Information til brugeren Imatinib Teva 400 mg hårde kapsler imatinib
English: NAME OF THE MEDICINAL PRODUCT Imatinib Teva 100 mg film-coated tablets imatinib
Danish: Indlægsseddel: Information til brugeren Imatinib Teva 100 mg filmovertrukne tabletter imatinib
English: NAME OF THE MEDICINAL PRODUCT Imatinib Teva 400 mg film-coated tablets imatinib
Danish: Indlægsseddel: Information til brugeren Imatinib Teva 400 mg filmovertrukne tabletter imatinib
English: The starting dose is 100 mg, to be taken as 1 tablet once a day.
Danish: Startdosis er 100 mg, som skal tages som 1 tablet én gang daglig.
English: Complete (Confirmed3) [95% CI]
Danish: Cytogenetisk hovedrespons2 Fuldstændigt (Bekræftet3) [95% CI]
English: Imatinib Teva 100 mg film-coated tablets
Danish: Imatinib Teva 100 mg filmovertrukne tabletter
English: NAME OF THE MEDICINAL PRODUCT Imatinib Teva 100 mg hard capsules imatinib
Danish: Indlægsseddel: Information til brugeren Imatinib Teva 100 mg hårde kapsler imatinib
English: 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.
Danish: 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.
English: Imatinib Teva 400 mg film-coated tablets
Danish: Imatinib Teva 400 mg filmovertrukne tabletter
English: 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.
Danish: 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.
English: 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
Danish: = 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
English: 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.
Danish: 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.
English: IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
Danish: Tredobbelt i.t.-terapi (aldersjusteret): dag 8, 15
English: 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).
Danish: 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.
English: Liver dysfunction classification:
Danish: Klassificering af nedsat leverfunktion: Nedsat leverfunktion
English: - Each film-coated tablet of Imatinib Teva contains 400 mg imatinib (as mesilate).
Danish: - Hver Imatinib Teva-filmovertrukken tablet indeholder 400 mg imatinib (som mesilat).
English: 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.
Danish: 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.
English: 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.
Danish: 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).
English: CPM (250 mg/m2/dose q12h x 4 doses, iv): Days 3 and 4 PEG-ASP (2500 IUnits/m2, IM): day 4
Danish: CPM (250 mg/m2/dosis q12h x 4 doser, i.v.
English: During treatment with Imatinib Teva, tell your doctor straight away if you put on weight very quickly.
Danish: Du skal straks fortælle din læge, hvis du meget hurtigt tager på i vægt, mens du er i behandling med Imatinib Teva.
English: 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.
Danish: 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.
English: What you need to know before you take Imatinib Teva 3.
Danish: Det skal du vide, før du begynder at tage Imatinib Teva Sådan skal tage Imatinib Teva Bivirkninger
English: Of a panel of potential comedications (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin,
Danish: 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.
English: - 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.
Danish: - 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.
English: Hepatic insufficiency
Danish: Brystsmerter, utilpashed
English: (1 h), days 26, 46;
Danish: ): dag 43, 44
English: (0.5 h), days 7, 8, 14, 15;
Danish: ): dag 1, 8, og 15
English: PHARMACEUTICAL FORM AND CONTENTS
Danish: LISTE OVER HJÆLPESTOFFER LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE)
English: Vincristine 2 mg i.v., days 4, 11; Doxorubicine 50 mg/m2 i.v.
Danish: (3 timer, q 12 timer), dag 1-3; vinkristin 2 mg i.v., dag 4, 11; doxorubicin 50 mg/m2 i.v.
English: - Each film-coated tablet of Imatinib Teva contains 100 mg imatinib (as mesilate).
Danish: - Hver Imatinib Teva filmovertrukken tablet indeholder 100 mg imatinib (som mesilat).
English: България Актавис ЕАД
Danish: BN22 9AG Storbritannien
English: - Each hard capsule of Imatinib Teva contains 100 mg imatinib (as mesilate).
Danish: - Hver kapsel indeholder 100 mg imatinib (som mesilat).
English: Very common (may affect more than 1 in 10 people):
Danish: Andre bivirkninger kan omfatte: Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter):
English: DEX 10 mg/m2 oral, days 1-5;
Danish: DEX 10 mg/m2 oral, dag 1-5; VCR 2 mg i.v.,
English: MTX 15 mg intrathecal, days 1, 8, 15, 22;
Danish: 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,
English: Triple IT therapy (age-adjusted): days 1, 29 VCR (1.5 mg/m2, IV): days 1, 29
Danish: Tredobbelt i.t.-terapi (aldersjusteret): dag 1, 29
English: Printing ink Shellac
Danish: Leversvigt8, levernekrose
English: (24 h), day 4;
Danish: timer), dag 5
English: Nederland Teva Nederland B.V. Tel: +31 8000228400
Danish: Tel: +31 8000228400
English: Partial CyR n (%)
Danish: CHR rate n (%) [95% CI]
English: Capsule content Mannitol
Danish: Mave-tarm-kanalen
English: 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
Danish: ): dag 1-5 G-CSF (5 μg/kg, s.c.): dag 6-15, eller indtil ANC > 1500 post nadir I.t.
English: Tablet coat
Danish: Tabletkerne:
English: VCR (1.5 mg/m2/day, IV): days 1, 8 and 15
Danish: Methotrexate (5 g/m2 over 24 hours, IV): days 1 and 15
English: VCR (1.5 mg/m2/day, IV): days 1, 8, and 15
Danish: VCR (1,5 mg/m2/dag, i.v.
English: Anaphylactic shock* Blood and lymphatic system disorders Very common
Danish: Blod og lymfesystem
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Danish: Hver filmovertrukken tablet indeholder 100 mg imatinib (som mesilat).
English: Contents of the pack and other information What Imatinib Teva contains - The active substance is imatinib (as mesilate).
Danish: Pakningsstørrelser og yderligere oplysninger Imatinib Teva indeholder:
English: - Each hard capsule of Imatinib Teva contains 400 mg imatinib (as mesilate).
Danish: Hver kapsel indeholder 400 mg imatinib (som mesilat).
English: doses)iii: days 2 and 3
Danish: eller p.o. q6h x 6 doses)iii: dag 2 og 3
English: (q 12 h), days 2-3, for 4 cycles
Danish: 2-3, i 4 cyklus
English: NAME OF THE MEDICINAL PRODUCT Imatinib Teva 100 mg film-coated tablets Imatinib Teva 400 mg film-coated tablets
Danish: Imatinib Teva 100 mg filmovertrukne tabletter Imatinib Teva 400 mg filmovertrukne tabletter
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 400 mg of imatinib (as mesilate).
Danish: Hver filmovertrukken tablet indeholder 400 mg imatinib (som mesilat).
English: This summary was last updated on 22/04/2013.
Danish: Dette sammendrag blev sidst ajourført den 22/04/2013.
English: In very rare cases they may be serious or fatal.
Danish: I meget sjældne tilfælde kan bivirkningerne være alvorlige eller dødelige.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Meloxidolor on 22/04/2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Meloxidolor den 22/04/2013.
English: It must not be used in cats weighing less than 2 kg.
Danish: Det må ikke anvendes til katte, der vejer under 2 kg.
English: In dogs, these generally occur within the first week of treatment and usually disappear once treatment has stopped.
Danish: Hos hunde optræder bivirkningerne normalt i den første uge af behandlingen og svinder sædvanligvis, når behandlingen ophører.
English: The product is not authorised for use in horses producing milk for human consumption.
Danish: Produktet bør ikke anvendes til heste, der producerer mælk til konsum.
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Meloxidolor.
Danish: Personer, som er overfølsomme (allergiske) over for NSAID, bør undgå kontakt med Meloxidolor.
English: It must not be used in animals which are hypersensitive (allergic) to the active substance or to any of the other ingredients.
Danish: Det må ikke anvendes hos dyr, der er overfølsomme (allergiske) over for det aktive stof eller andre af indholdsstofferne.
English: 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.
Danish: 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.
English: Other information about Meloxidolor:
Danish: Andre oplysninger om Meloxidolor:
English: Meloxidolor is a medicine that contains the active substance meloxicam.
Danish: Meloxidolor er et lægemiddel, der indeholder det aktive stof meloxicam.
English: 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.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter lægemidlets indgivelse, før dyret kan slagtes, og kødet kan anvendes til konsum.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Danish: Forholdet mellem fordele og risici fremgår af afsnittet med den videnskabelige drøftelse i denne EPAR.
English: 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.
Danish: Udvalget for Lægemidler til Dyr (CVMP) vurderede, at det i overensstemmelse med EU-kravene er blevet påvist, at Meloxidolor er bioækvivalent med Metacam.
English: 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.
Danish: Det vil sige, at det svarer til et veterinært “referencelægemiddel”, der indeholder samme aktive stof, men det fås også i en højere styrke.
English: Meloxidolor contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Danish: Meloxidolor indeholder meloxicam, som tilhører lægemiddelgruppen ikke-steroide antiinflammatoriske lægemidler (NSAID).
English: For intravenous use no studies in animals were needed as Meloxidolor contains the same active substance as the reference medicine Metacam.
Danish: Til intravenøs anvendelse var det ikke nødvendigt med undersøgelser hos dyr, da Meloxidolor indeholder det samme aktive stof som referencelægemidlet Metacam.
English: Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
Danish: Meloxicam virker ved at blokere enzymet cyclooxygenase, der medvirker ved produktionen af prostaglandiner.
English: 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.
Danish: Da Meloxidolor anses for bioækvivalent med referencelægemidlet, forventes det at have de samme fordele som referencelægemidlet.
English: In horses, a temporary swelling at the injection site can occur but resolves without intervention.
Danish: Hos heste kan der på injektionsstedet forekomme midlertidig hævelse, som svinder uden behandling.
English: Meloxidolor is a 'generic'.
Danish: Meloxidolor er et “generisk lægemiddel”.
English: It is also the time allowed after administration of the medicine before the milk can be used for human consumption.
Danish: Det er desuden den tid, der skal gå, efter at dyret har fået lægemidlet, før mælken kan anvendes til konsum.
English: Pregnant women and women of child-bearing potential should not administer Meloxidolor as meloxicam may be harmful for the foetus and unborn child.
Danish: Meloxidolor bør ikke indgives af kvinder, der er gravide eller muligvis er gravide, da meloxicam kan være skadeligt for fosteret og det ufødte barn.
English: It is available as a solution for injection (5 mg/ml, 20 mg/ml and 40 mg/ml).
Danish: Det leveres som en injektionsvæske, opløsning (5 mg/ml, 20 mg/ml og 40 mg/ml).
English: 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.
Danish: 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.
English: What is the risk associated with Meloxidolor?
Danish: Hvilken risiko er der forbundet med Meloxidolor?
English: 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.
Danish: Det kan sammen med oral rehydreringsbehandling anvendes til behandling af diarré hos kalve over en uge gamle og hos ungkvæg, der ikke er diegivende.
English: 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.
Danish: Meloxidolor bør ikke anvendes til drægtige eller diegivende hunde, katte eller heste, men hos kvæg og svin kan det anvendes under drægtighed og diegivning.
English: 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.
Danish: 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.
English: Why has Meloxidolor been approved?
Danish: Hvorfor blev Meloxidolor godkendt?
English: 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.
Danish: I meget sjældne tilfælde kan der optræde anafylaktoide reaktioner (svarende til svær allergi) efter indgift af injektionsvæsken.
English: 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.
Danish: Meloxidolor må ikke anvendes til dyr med lever-, hjerte- eller nyrelidelser, blødningsforstyrrelser eller irritation eller sår i mave-tarmkanalen.
English: 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.
Danish: Da prostaglandiner er stoffer, der udløser irritation af vævet, smerte, væskeudskillelse og feber, mindsker meloxicam disse reaktioner.
English: A slight temporary swelling at the injection site following injection under the skin was observed in cattle and pigs.
Danish: Efter injektion under huden hos kvæg og svin sås en midlertidig let hævelse på injektionsstedet.
English: What is Meloxidolor?
Danish: Hvad er Meloxidolor?
English: What is Meloxidolor used for?
Danish: Hvad anvendes Meloxidolor til?
English: How has Meloxidolor been studied?
Danish: Hvordan blev Meloxidolor undersøgt?
English: 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).
Danish: Injektionsvæsken i styrkerne 20 mg/ml og 40 mg/ml anvendes desuden i kombination med antibiotika til behandling af akut mastitis (yverbetændelse).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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).
Danish: 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.
English: What benefit has Meloxidolor shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Meloxidolor?
English: 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).
Danish: 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).
English: 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.
Danish: Hos hunde og katte medfører Meloxidolor lejlighedsvis bivirkninger svarende til andre NSAID, dvs. appetitløshed, opkastning, diarré, synligt blod i afføringen, nyresvigt og sløvhed.
English: How does Meloxidolor work?
Danish: Hvordan virker Meloxidolor?
English: 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).
Danish: 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.
English: − thirst and increased water consumption
Danish: − Tørst og øget vandforbrug
English: Not known (frequency cannot be estimated from the available data)
Danish: Ikke kendt (hyppigheden kan ikke vurderes udfra forhåndenværende data)
English: You must contact your doctor immediately if you notice any of the following:
Danish: Du skal omgående kontakte din læge, hvis du mærker nogen af følgende bivirkninger:
English: − if you have recently received or are about to receive a vaccine against yellow fever.
Danish: − hvis du for nylig er blevet eller snart skal vaccineres mod gul feber.
English: In the absence of other compatibility studies this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger andre studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: PFS data were partially confirmed by an independent review (400/1,725 patients were randomly selected for review).
Danish: PFS data blev delvist bekræftet af en uafhængig undersøgelse (400/1.725 patienter blev randomiseret og udvalgt til undersøgelsen).
English: There are many sorts of NSAIDs with different durations of activity.
Danish: Der findes mange slags NSAIDpræparater med forskellig varighed af det aktive stof.
English: • Non-inferiority p-value (HR) Progression free survival (months)
Danish: • P-værdi for non-inferioritet (HR) Progressionsfri overlevelse (måneder)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 November 2015
Danish: Dato for første markedsføringstilladelse: 27 november 2015