FrancophonIA/ELRC3.0 huggingface dataset:
English: protease inhibitors used in the treatment of Human Immunodeficiency Virus (HIV) antibiotics (including rifampicin) or antifungal medicines (including itraconazole, ketoconazole and voriconazole) used to treat infections nefazodone or selective serotonin re-uptake inhibitors used to treat depression anti-epileptic medicines, including carbamazepine, phenytoin and phenobarbital rifabutin used to treat infection in people with HIV and other diseases herbal medicines or natural remedies containing St. John's wort (Hypericum perforatum) used to treat mild depression angiotensin converting enzyme (ACE) inhibitors (such as enalapril, ramipril, lisinopril) or a calcium channel blocker (such as amlodipine) used to treat high blood pressure or other cardiovascular problems amphiphilic medicines used to treat heart arrhythmias (such as amiodarone), or statins used to treat high cholesterol sunitinib used to treat cancer of the kidney medicines which are P-gp substrates (such as digoxin, vincristine, colchicine, dabigatran, lenalidomide, paclitaxel)
Norwegian Bokmål: - proteasehemmere som brukes i behandling av humant immunsviktvirus (HIV) - antibiotika (inkludert rifampicin) eller soppmidler (inkludert itrakonazol, ketokonazol og vorikonazol) som brukes til å behandle infeksjoner - nefazodon eller selektive serotoninreopptakshemmere som brukes til å behandle depresjon - antiepileptika, inkludert karbamazepin, fenytoin og fenobarbital - rifabutin som brukes til å behandle infeksjon hos personer med HIV og andre sykdommer - plantebaserte legemidler eller naturmidler som inneholder johannesurt (Hypericum perforatum)
English: Dose reduction level
Norwegian Bokmål: Dosereduksjonsnivå
English: The solvent contains: polysorbate 80 (E 433), macrogol 400 and anhydrous ethanol.
Norwegian Bokmål: Væsken inneholder: polysorbat 80 (E 433), makrogol 400 og vannfri etanol.
English: Constipation
Norwegian Bokmål: Frysninger
English: In 36 patients with MCL, including 4 poor metabolisers, the effect of CYP2D6 inhibition after administration of single doses of 175 mg and 75 mg temsirolimus was investigated.
Norwegian Bokmål: Effekten av CYP2D6-hemming etter administrering av enkeltdoser på 175 mg og 75 mg temsirolimus ble undersøkt hos 36 pasienter med MCL, inklusiv 4 langsomme omsettere (‘poor metabolisers').
English: The required amount of concentrate--solvent mixture from each vial must be combined in one syringe for rapid injection into 250 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (see section 4.2).
Norwegian Bokmål: Den nødvendige mengden av konsentrat-væskeblanding fra hvert hetteglass må overføres til en sprøyte for rask injeksjon inn i 250 ml natriumklorid 9 mg/ml (0,9 %) injeksjonsvæske, oppløsning (se pkt.
English: Co-administration of temsirolimus 5 mg with ketoconazole, a potent CYP3A4 inhibitor, had no significant effect on temsirolimus Cmax or AUC; however, sirolimus AUC increased 3.1-fold, and AUCsum (temsirolimus + sirolimus) increased 2.3-fold compared to temsirolimus alone.
Norwegian Bokmål: Samtidig administrering av temsirolimus og rifampicin, en potent CYP3A4/5-induktor, hadde ingen signifikant effekt på maksimal konsentrasjon (Cmax) av temsirolimus og areal under konsentrasjon vs. tid-kurven (AUC) etter intravenøs administrering, men reduserte Cmax med 65 % og AUC med 56 % for sirolimus, sammenlignet med behandling med temsirolimus alene.
English: For patients with RCC and severe hepatic impairment, the recommended dose for patients who have baseline platelets 100 x 109/l is 10 mg intravenous once a week infused over a 30-60 minute period (see section 5.2).
Norwegian Bokmål: For pasienter med RCC og alvorlig nedsatt leverfunksjon er den anbefalte dosen 10 mg intravenøst én gang i uken infundert over en periode på 30-60 minutter hos pasienter som har antall blodplater ved baseline på ≥ 100 × 10
English: DATE OF REVISION OF THE TEXT
Norwegian Bokmål: Sammensetning av Torisel
English: The concentrate-solvent mixture may only be administered in sodium chloride 9 mg/ml (0.9%) solution for injection.
Norwegian Bokmål: Konsentrat-væskeblandingen skal kun gis sammen med natriumklorid 9 mg/ml (0,9 %) injeksjonsvæske, oppløsning.
English: 150 mg/m2.
Norwegian Bokmål: (50 000 celler/mm 3).
English: Very common Arthralgia Back pain
Norwegian Bokmål: Svært vanlige Artralgi Ryggsmerter
English: Temsirolimus is not recommended for use in paediatric patients (see sections 4.2, 4.8 and 5.1).
Norwegian Bokmål: Temsirolimus er ikke anbefalt til bruk hos pediatriske pasienter (se pkt.
English: Thrombophlebitis
Norwegian Bokmål: Mantelcellelymfom
English: Uncommon side effects (may affect up to 1 in 100 people):
Norwegian Bokmål: Mindre vanlige bivirkninger (kan berøre opptil 1 av 100 personer):
English: STEP 2: ADMINISTRATION OF CONCENTRATE FOR SOLUTION FOR INFUSION SOLVENT MIXTURE IN SODIUM CHLORIDE 9 MG/ML (0.9%) SOLUTION FOR INJECTION
Norwegian Bokmål: TRINN 2: ADMINISTRERING AV KONSENTRAT-VÆSKEBLANDINGEN TIL INFUSJONSVÆSKE, OPPLØSNING I NATRIUMKLORID 9 MG/ML (0,9 %) INJEKSJONSVÆSKE, OPPLØSNING
English: Co-administration of temsirolimus with rifampicin, a potent CYP3A4/5 inducer, had no significant effect on temsirolimus maximum concentration (Cmax) and area under the concentration vs. time curve
Norwegian Bokmål: Samtidig administrering av temsirolimus 5 mg og ketokonazol, en potent CYP3A4-hemmer, hadde ingen signifikant effekt på Cmax eller AUC for temsirolimus.
English: Excipients
Norwegian Bokmål: Parestesier
English: STEP 2: ADMINISTRATION OF CONCENTRATE FOR SOLUTION FOR INFUSION-SOLVENT MIXTURE IN SODIUM CHLORIDE 9MG/ML (0.9%) SOLUTION FOR INJECTION
Norwegian Bokmål: TRINN 2: ADMINISTRERING AV KONSENTRAT TIL INFUSJONSVÆSKE/VÆSKEBLANDING I NATRIUMKLORID 9 MG/ML (0,9 %) INJEKSJONSVÆSKE, OPPLØSNING
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of concentrate for solution for infusion contains 30 mg temsirolimus.
Norwegian Bokmål: Hvert hetteglass med konsentrat til infusjonsvæske, oppløsning inneholder 30 mg temsirolimus.
English: Promptly tell your doctor of any new or worsening respiratory symptoms such as shortness of breath or difficulty breathing.
Norwegian Bokmål: Si ifra til legen din med én gang dersom du får nye luftveissymptomer, eller forverring av eksisterende symptomer, for eksempel om du er tungpusten eller har pusteproblemer.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Torisel 30 mg sterile concentrate temsirolimus
Norwegian Bokmål: Torisel 30 mg sterilt konsentrat temsirolimus
English: Uncommon Impaired wound healing
Norwegian Bokmål: Mindre vanlige Svekket sårtilheling
English: Anhydrous ethanol all-rac-α-Tocopherol (E 307) Propylene glycol Citric acid (E 330)
Norwegian Bokmål: Alfa-tokoferol, helracemisk (E 307) Propylenglykol
English: If the patient cannot maintain ANC 1.0 x 109/l and platelets 50 x 109/l on the new dose reduction level, then the next lower dose should be given once the counts have recovered.
Norwegian Bokmål: 9/l ved det nye dosereduksjonsnivået, skal den neste, lavere dosen først gis når antallet er gjenopprettet.
English: Mucosal inflammation Pyrexia
Norwegian Bokmål: Bihulebetennelse Rhinitt
English: Hypersensitivity reactions / drug hypersensitiviy
Norwegian Bokmål: Overfølsomhetsreaksjoner/ overfølsomhet overfor legemidlet
English: Aphthous stomatitis
Norwegian Bokmål: Nyrecellekarsinom
English: Uncommon Laryngitis
Norwegian Bokmål: Mindre vanlige Laryngitt
English: Folliculitis
Norwegian Bokmål: Temsirolimusdose
English: In 23 healthy subjects the concentration of desipramine, a CYP2D6 substrate, was unaffected when 25 mg of temsirolimus was co-administered.
Norwegian Bokmål: Samtidig administrering av 25 mg temsirolimus til 23 friske frivillige påvirket ikke konsentrasjonen av desipramin, et CYP2D6-substrat.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Torisel
Norwegian Bokmål: LEGEMIDLETS NAVN OG ADMINISTRASJONSVEI
English: Common side effects (may affect up to 1 in 10 people):
Norwegian Bokmål: Vanlige bivirkninger (kan berøre opptil 1 av 10 personer):
English: Rhinitis
Norwegian Bokmål: Follikulitt
English: Temsirolimus should be used with caution in patients with hepatic impairment (see section 4.4).
Norwegian Bokmål: Nedsatt leverfunksjon Temsirolimus bør brukes med forsiktighet hos pasienter med nedsatt leverfunksjon (se pkt.
English: IV use
Norwegian Bokmål: VEDLEGG II
English: The concentrate for solution for infusion must be diluted with the supplied solvent before administration in sodium chloride 9 mg/ml (0.9%) solution for injection.
Norwegian Bokmål: Konsentrat til infusjonsvæske skal fortynnes med medfølgende oppløsningsvæske før det tilsettes i natriumklorid 9 mg/ml (0,9 %) injeksjonsvæske, oppløsning.
English: Upper respiratory tract infection Pharyngitis
Norwegian Bokmål: Øvre luftveisinfeksjoner Faryngitt **
English: Very common Rash (including rash, pruritic rash, maculo-papular rash, rash, generalised rash, macular rash, papular rash) Pruritus (including pruritus generalised)
Norwegian Bokmål: Svært vanlige Utslett (inkludert utslett, kløende utslett, makulopapulært utslett, generalisert utslett, makulært utslett, papuløst utslett) Kløe (inkludert generalisert kløe)
English: 50 x 109/l
Norwegian Bokmål: 9/l og blodplater > 50 × 10
English: 1.0 x 109/l
Norwegian Bokmål: 9/l
English: If you are concerned about this, tell your doctor immediately.
Norwegian Bokmål: Informer legen med én gang dersom du er bekymret for dette.
English: These symptoms might be caused by a perforation in your gut.
Norwegian Bokmål: Disse symptomene kan skyldes at det har gått hull på tarmene dine.
English: NN:
Norwegian Bokmål: SN: <NN:>
English: a Hazard ratio IFN-α n = 207 P-value (95% CI)
Norwegian Bokmål: IFN-alfa n = 207
English: A benefit-risk assessment should be done prior to the continuation of temsirolimus therapy in patients with severe or life-threatening reactions.
Norwegian Bokmål: Hos pasienter med alvorlige eller livstruende reaksjoner, bør en nytte/risiko-analyse utføres før behandling med temsirolimus fortsetter.
English: However, sirolimus, the main metabolite of temsirolimus, is excreted in milk of lactating rats.
Norwegian Bokmål: Utskillelse av temsirolimus i melk er ikke undersøkt hos dyr, men sirolimus, hovedmetabolitten til temsirolimus, utskilles i melk hos lakterende rotter.
English: Dilution
Norwegian Bokmål: Svimmelhet
English: Pack size: 1 vial of concentrate and 1 vial of solvent
Norwegian Bokmål: Pakningsstørrelse: 1 hetteglass med konsentrat og 1 hetteglass med oppløsningsvæske.
English: 0.0009c
Norwegian Bokmål: 1050 Bruxelles
English: You should seek medical advice immediately if you suffer from general swelling, shortness of breath, tiredness.
Norwegian Bokmål: Du bør oppsøke lege øyeblikkelig dersom du opplever at du er generelt opphovnet, andpusten eller trett.
English: Pain
Norwegian Bokmål: ESKE
English: Disposal
Norwegian Bokmål: Fortynning
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate and solvent for solution for infusion
Norwegian Bokmål: Konsentrat og væske til infusjonsvæske, oppløsning
English: Temsirolimus elimination by the kidneys is negligible; studies in patients with varying renal impairment have not been conducted (see sections 4.2 and 5.2).
Norwegian Bokmål: Ingen studier er utført hos pasienter med varierende grad av nedsatt nyrefunksjon (se pkt.
English: Note: For mantle cell lymphoma, multiple vials will be required for each dose over 25 mg. Each vial of Torisel must be diluted according to the instructions below.
Norwegian Bokmål: NB: Ved mantelcellelymfom vil det være behov for flere hetteglass for hver dose over 25 mg.
English: ----------------Study 2--------------- -------------Study 3------------- -------------Study 4------------Placebo
Norwegian Bokmål: --------------------Studju 2----------------- ----------------Studju 3--------
English: The absolute bioavailability is 76%.
Norwegian Bokmål: Il-bijodisponibiltà assoluta hi ta' 76%.
English: 6.2 Incompatibilities
Norwegian Bokmål: 6.2 Inkompatibilitajiet
English: • The risk of opportunistic infections and tuberculosis (TB)
Norwegian Bokmål: • Ir-riskju ta' infezzjonijiet opportunistiċi u tuberkolożi (TB)
English: Sepsis or risk of sepsis.
Norwegian Bokmål: Sepsis jew riskju ta' sepsis.
English: Tuberculosis
Norwegian Bokmål: Tuberkulosi
English: D-88397 Biberach an der Riss
Norwegian Bokmål: D-88397 Biberach an der Riss Il-Ġermanja
English: Clinical efficacy and safety
Norwegian Bokmål: Effettività u sigurtà klinika
English: System Organ Class
Norwegian Bokmål: Sistema talKlassifika talOrgani
English: Adults
Norwegian Bokmål: Adulti
English: TSS Erosions JSN
Norwegian Bokmål: TSS Erozjoni JSN
English: 4.3 Contraindications
Norwegian Bokmål: 4.3 Kontra-indikazzjonijiet
English: PASI 50 14 58* 70 74* 77 9 PASI 75 4 34* 44 49* 59 3
Norwegian Bokmål: PASI 50 14 58* 70 74* 77 9 64* 77* 9 69* 83 PASI 75 4 34* 44 49* 59 3 34* 49* 2 38* 71 DSGA
English: LIFMIOR N=103 to 105*
Norwegian Bokmål: LIFMIOR N=103 sa 105*
English: PASI 75, n (%)
Norwegian Bokmål: PASI 75, n (%) PASI 50, n (%)
English: Rare ≥ 1/10,000 to
Norwegian Bokmål: Rari ≥ 1/10,000 sa
English: Distribution
Norwegian Bokmål: Distribuzzjoni
English: Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgium
Norwegian Bokmål: Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Il-Belġju
English: Hepatitis B reactivation, listeria
Norwegian Bokmål: Riattivazzjoni tal-epatite B, listeria,
English: Patients had previously been treated with NSAIDs (86%), DMARDs (80%), and corticosteroids (24%).
Norwegian Bokmål: Il-pazjenti kienu kkurati qabel b'NSAIDs (86%), DMARDs (80%), u kortikosterojdi (24%).
English: See section 4.4.
Norwegian Bokmål: Ara sezzjoni 4.4.
English: Possible side effects
Norwegian Bokmål: Effetti sekondarji possibbli
English: Uveitis, scleritis
Norwegian Bokmål: Uveite, sklerite
English: Placebo (N = 105)
Norwegian Bokmål: Plaċebo (N = 105)
English: Placebo N=106 to 109*
Norwegian Bokmål: Plaċebo N=106 sa 109*
English: Placebo N = 139
Norwegian Bokmål: Plaċebo N = 139
English: Wegener's granulomatosis
Norwegian Bokmål: Granulomatożi ta' Wegener
English: This is normal.)
Norwegian Bokmål: Dan hu normali.)
English: PFIZER EΛΛAΣ A.E. (CYPRUS BRANCH) Tηλ: +357 22 817690
Norwegian Bokmål: PFIZER EΛΛAΣ A.E. (CYPRUS BRANCH) T : +357 22 817690
English: Hampshire, PO9 2NG United Kingdom
Norwegian Bokmål: Hampshire, PO9 2NG Ir-Renju Unit
English: Manufacturer:
Norwegian Bokmål: Manifattur:
English: The specific activity of etanercept is 1.7 x 106 units/mg.
Norwegian Bokmål: L-attività speċifika ta' etanercept hi 1.7 x 106 unitajiet/mg.
English: 4 years.
Norwegian Bokmål: 4 snin.
English: Double-Blind Clinical Responses at Week 12
Norwegian Bokmål: Risponsi kliniċi double-blind filĠimgħa 12
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors, ATC code: L04AB01
Norwegian Bokmål: Kategorija farmakoterapewtika: Immunosoppressanti, Inibituri alpha tal-Fattur tan-Nekrosi tat-Tumur (TNF-α), Kodiċi ATC: L04AB01
English: LIFMIOR 0.8 mg/kg Once Weekly (N = 106)
Norwegian Bokmål: LIFMIOR 0.8 mg/kg Darba filĠimgħa (N = 106)
English: Malignant melanoma (see section 4.4), lymphoma, leukaemia
Norwegian Bokmål: Melanoma malinna (ara sezzjoni 4.4), limfoma, lewkimja
English: Summary of the safety profile
Norwegian Bokmål: Sommarju tal-profil ta' sigurtà
English: UNIQUE IDENTIFIER-2D BARCODE 2D barcode carrying the unique identifier included.
Norwegian Bokmål: barcode 2D li jkollu l-identifikatur uniku inkluż.
English: Fertility
Norwegian Bokmål: Fertilità
English: Very Rare
Norwegian Bokmål: Rari Ħafna
English: Date of first authorisation: 13 February 2017 Date of last renewal: {DD month YYYY}
Norwegian Bokmål: Data ta' l-ewwel awtorizzazzjoni: 13 ta' Frar 2017 Data ta' l-aħħar tiġdid: {JJ xahar SSSS}
English: Toxic epidermal necrolysis
Norwegian Bokmål: Nekrolisi epidermali tossika
English: c: Remission is defined as DAS <1.6
Norwegian Bokmål: ċ: Tnaqqis fil-mard hu definita bħala DAS <1.6
English: Etanercept contains 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons.
Norwegian Bokmål: Etanercept fih 934 amino aċidi u għandu toqol molekulari apparenti ta' bejn wieħed u ieħor 150 kilodaltons.
English: Elimination
Norwegian Bokmål: Eliminazzjoni
English: Absorption
Norwegian Bokmål: Assorbiment
English: Adult population
Norwegian Bokmål: Popolazzjoni adulta
English: Nervous system disorders
Norwegian Bokmål: Disturbi fissistema nervuża
English: Immunosuppression
Norwegian Bokmål: Immunosoppressjoni
English: For the full list of excipients, see section 6.1.
Norwegian Bokmål: Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: Linearity
Norwegian Bokmål: Linearjetà
English: Serious allergic/anaphylactic reactions (including angioedema, bronchospasm), sarcoidosis
Norwegian Bokmål: Reazzjonijiet allerġiċi/anafilattiċi serji (inklużi anġjoedema, bronkospażmu), sarkojdożi
English: Pancytopenia*
Norwegian Bokmål: Panċitopenja*
English: 3 years.
Norwegian Bokmål: 3 snin.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Norwegian Bokmål: GĦAMLA KWALITATTIVA U KWANTITATTIVA
English: Immune system disorders
Norwegian Bokmål: Disturbi fissistema immuni
English: 4.6 Fertility, pregnancy and lactation
Norwegian Bokmål: 4.6 Fertilità, tqala u treddigħ
English: • Additional risk minimisation measures
Norwegian Bokmål: • Miżuri addizzjonali għall-minimizzazzjoni tar-riskji
English: Pancytopenia and aplastic anaemia
Norwegian Bokmål: Panċitopenja u anemija aplastika
English: Renal impairment
Norwegian Bokmål: Indeboliment renali
English: ACR Responsesa ACR 20
Norwegian Bokmål: Risponsi ACR ACR 20 ACR 50 ACR 70
English: Infections
Norwegian Bokmål: Infezzjonijiet
English: Histiocytosis haematophagic (macrophage activation syndrome)*
Norwegian Bokmål: Istijoċitożi ematofaġika (sindrome ta' attivazzjoni talmakrofagu)*
English: Reporting of side effects
Norwegian Bokmål: Rappurtar tal-effetti sekondarji
English: Name and address of the manufacturers of the biological active substance Boehringer Ingelheim Pharma KG
Norwegian Bokmål: Isem u indirizz tal-manifatturi tas-sustanza bijoloġika attiva Boehringer Ingelheim Pharma KG Birkendorfer Strasse 65
English: Serious infections (including pneumonia, cellulitis, arthritis bacterial, sepsis and parasitic infection)*
Norwegian Bokmål: Infezzjonijiet serji (inkluż pnewmonja, ċellulite, artrite batterjali, sepsis u infezzjoni parasitika)*
English: Stevens-Johnson syndrome, cutaneous vasculitis (including hypersensitivity vasculitis), erythema multiforme, lichenoid reactions
Norwegian Bokmål: Sindrome ta' Stevens-Johnson, vaskulite tal-ġilda (li tinkludi vaskulite b'sensittività eċċessiva), eritema multiforme, reazzjonijiet liċenojdi
English: Tuberculosis, opportunistic infection (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections, and Legionella)*
Norwegian Bokmål: Tuberkulożi, infezzjoni opportunistika (li tinkludi infezzjonijiet fungali invażivi, protożoali, batterjali, mikobatterjali atipiċi, virali u Leġjonella)*
English: 30 months.
Norwegian Bokmål: 30 xahar.
English: Contents of the pack and other information
Norwegian Bokmål: Kontenut tal-pakkett u informazzjoni oħra
English: In a pooled data set of clinical trials, the overall incidence of opportunistic infections was 0.09% for the 15,402 subjects who received LIFMIOR.
Norwegian Bokmål: F'sett ta' dejta miġbura ta' provi kliniċi, l-inċidenza totali ta' infezzjonijiet opportunistiċi kienet ta' 0.09% għal 15,402 persuna li rċivew LIFMIOR.
English: Thrombocytopenia, anaemia, leukopenia, neutropenia
Norwegian Bokmål: Tromboċitopenja, anemija, lewkopenja, newtropenja
English: Aplastic anaemia*
Norwegian Bokmål: Anemija aplastika*
English: This appearance is normal for LIFMIOR.
Norwegian Bokmål: Din id-dehra hi normali għal LIFMIOR.
English: See section 4.
Norwegian Bokmål: Ara sezzjoni 4.
English: 4.9 Overdose
Norwegian Bokmål: 4.9 Doża eċċessiva
English: Cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus, lupus-like syndrome
Norwegian Bokmål: Lupus erythematosus tal-ġilda, lupus erythematosus sottoakut tal-ġilda, sindrome simili għall-lupus
English: 5.2 Pharmacokinetic properties
Norwegian Bokmål: 5.2 Tagħrif farmakokinetiku
English: Musculoskeletal and connective tissue disorders
Norwegian Bokmål: Disturbi muskoluskeletriċi u tattessuti konnettivi
English: Axial spondyloarthritis
Norwegian Bokmål: Spondiloartrite assjali
English: The active substance in LIFMIOR is etanercept.
Norwegian Bokmål: Is-sustanza attiva f'LIFMIOR hi etanercept.
English: Serious allergic reactions are rare.
Norwegian Bokmål: Reazzjonijiet allerġiċi serji huma rari.
English: Powder: Mannitol (E421), sucrose, and trometamol.
Norwegian Bokmål: Trab: Mannitol (E421), sucrose u trometamol
English: Introduction
Norwegian Bokmål: Introduzzjoni
English: Abbreviation: sPGA-static Physician Global Assessment a. p < 0.0001 compared with placebo
Norwegian Bokmål: sPGA “ċara” jew “minima”, n (%) Taqsira: sPGA-static Physician Global Assessment a. p < 0.0001 meta mqabbel mal-plaċebo
English: b: Values for Disease Activity Score (DAS) are means.
Norwegian Bokmål: b: Il-valuri għal Disease Activity Score (DAS) huma medji.
English: 46a
Norwegian Bokmål: ġimgħ a 12
English: At week 104, 8 subjects had progressed to a score of bilateral Grade 2 on spinal X-ray according to the modified New York Radiological Grade, indicative of axial spondyloarthropathy.
Norwegian Bokmål: Fil-ġimgħa 104, 8 individwi avvanzaw għal punteġġ ta' Grad 2 bilaterali fuq Raġġi-X tas-sinsla skont il-Grad Radjoloġiku ta' New York modifikat, indikattiv ta' spondiloartropatija assjali.
English: Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis including ankylosing spondylitis
Norwegian Bokmål: Artrite rewmatojde, artrite psorjatika, u spondiloartrite assjali li tinkludi ankylosing spondylitis
English: MTX LIFMIOR 25 mg
Norwegian Bokmål: MTX Enbrel 25 mg
English: Tabulated list of adverse reactions
Norwegian Bokmål: Tabella b'lista ta' avvenimenti avversi
English: In subjects treated with approved doses of etanercept in clinical trials for up to 12 months, cumulative rates of anti-etanercept antibodies were approximately 6% of subjects with rheumatoid arthritis, 7.5% of subjects with psoriatic arthritis, 2% of subjects with ankylosing spondylitis, 7% of subjects with psoriasis, 9.7% of subjects with paediatric psoriasis, and 4.8% of subjects with juvenile idiopathic arthritis.
Norwegian Bokmål: F'pazjenti kkurati b'dożi approvati ta' etanercept fi provi kliniċi sa 12-il xahar, ir-rati kumulattivi ta' antikorpi għal etanercept kienu ta' madwar 6% tal-pazjenti b'artrite rewmatojde, 7.5% tal-pazjenti b'artrite psorjatika 2% tal-pazjenti bi ankylosing spondylitis, 7% tal-pazjenti bi psorjasi, 9.7% talpazjenti bi psorjasi pedjatrika, u 4.8% tal-pazjenti b'artrite idjopatika taż-żgħażagħ.
English: Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system.
Norwegian Bokmål: Etanercept hu proteina umana b'fattur nekrotiku għat-tumuri b'funzjoni tar-riċettur p75 Fc, prodott b'teknoloġija rikombinanti tad-DNA bis-sistema ta' espressjoni mammifera fl-ovarji ta' ħamster Ċiniż (CHO).
English: Vasculitis (including antineutrophilic cytoplasmic antibody positive vasculitis)
Norwegian Bokmål: Vaskulite (inkluż vaskulite pożittiva tal-antikorpi ċitoplażmika antinewtrofilika)
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Norwegian Bokmål: Għall-kundizzjonijiet ta' ħażna tal-prodott mediċinali rikostitwit, ara sezzjoni 6.3.
English: Diagram 8
Norwegian Bokmål: Dijagramma 8