FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med XELJANZ Fortæl lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg film-coated tablets tofacitinib
Danish: LÆGEMIDLETS NAVN XELJANZ 5 mg filmovertrukne tabletter tofacitinib
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/001 60 film-coated tablets EU/1/17/1178/002 180 film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1178/001 60 filmovertrukne tabletter EU/1/17/1178/002 180 filmovertrukne tabletter
English: Tofacitinib 5 mg Twice Daily Monotherapy N=370
Danish: Tofacitinib som monoterapi 5 mg 2 gange dagligt N= 370
English: NAME OF THE MEDICINAL PRODUCT XELJANZ 10 mg film-coated tablets tofacitinib
Danish: LÆGEMIDLETS NAVN XELJANZ 10 mg filmovertrukne tabletter tofacitinib
English: Women of childbearing potential should be advised to use effective contraception during treatment with tofacitinib and for at least 4 weeks after the last dose.
Danish: Kvinder i den fertile alder skal rådes til at bruge effektiv prævention under behandling med tofacitinib
English: Tofacitinib 10 mg Twice Daily Monotherapy N=394
Danish: Tofacitinib som monoterapi 10 mg 2 gange dagligt N= 394
English: Your doctor will test you for tuberculosis before starting XELJANZ and may retest during treatment - if you have any chronic lung disease - if you have liver problems - if you have or had hepatitis B or hepatitis C (viruses that affect the liver).
Danish: - hvis du har eller har haft hepatitis B eller hepatitis C (virus, som påvirker leveren).
English: Paraesthesia
Danish: Hypertension
English: Tofacitinib 10 mg twice daily is contraindicated in patients who are at high risk for pulmonary embolism (see also section 4.3).
Danish: I kliniske studier og i rapporter efter markedsføring er der observeret pulmonal emboli (PE) hos patienter, som tager tofacitinib, Tofacitinib 10 mg 2 gange dagligt er kontraindiceret til patienter, som har høj risiko for pulmonal emboli (se også pkt.
English: d. Clinical response was defined as a decrease from baseline in Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the subscore for rectal bleeding of ≥ 1 point or absolute subscore for rectal bleeding of 0 or 1.
Danish: med en ledsagende reduktion af subscoren for rektal blødning på ≥ 1 point eller en absolut subscore for rektal blødning på 0 eller 1.
English: a. Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0. b. Included TNF Inhibitor naïve patients c. Improvement of endoscopic appearance of the mucosa was defined as Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern).
Danish: Omfattede TNF-hæmmer-naive patienter c. Forbedring af endoskopisk udseende af slimhinden blev defineret som en Mayo-endoskopisk subscore på 0 (normal eller inaktiv sygdom) eller 1 (erythema, nedsat vaskulært mønster).
English: Renal impairment
Danish: Nervesyste met
English: 6 months
Danish: 6 måneder 1 år
English: Dose Adjustment
Danish: Dosisjustering
English: g
Danish: f
English: • swelling of the lips, tongue or throat
Danish: Knogler, led, muskler og bindevæv
English: In the controlled portion of the RA Phase 3 studies on background DMARDs (0-3 months) (studies II-V, see section 5.1), ALT elevations greater than 3x ULN were observed in 0.9%, 1.24% and 1.14% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
Danish: 5.1), blev der observeret stigninger i ALAT > 3 x ULN hos 0,9 %, 1,24 % og 1,14 % af de patienter, der fik henholdsvis placebo, 5 mg og 10 mg tofacitinib 2 gange dagligt.
English: With prior TNF inhibitor failure Without prior TNF inhibitor failureb
Danish: Uden tidligere svigt af TNFhæmmerb
English: • Once only.
Danish: • Kun én gang.
English: Note: This may take up to 5 minutes.
Danish: Bemærk: Dette kan tage op til 5 minutter.
English: Is this OK?
Danish: Er det OK?
English: You will also need:
Danish: Du har desuden brug for:
English: The maximum dose should not exceed 30 mg/day.
Danish: Den maksimale dosis bør ikke overstige 30 mg/dag.
English: It may take more effort to snap off than you might expect.
Danish: Det kan kræve flere kræfter at knække hætten af, end du måske forventer.
English: Some patients required hospitalization.
Danish: Hos nogle patienter krævede dette hospitalsindlæggelse.
English: There is also a risk you may lose some of the medicine.
Danish: Der er desuden risiko for, at du mister noget af lægemidlet.
English: • Abnormal dreams.
Danish: • Unormale drømme.
English: Contact your doctor immediately if you develop any of these symptoms.
Danish: Kontakt straks lægen, hvis du får nogle af disse symptomer
English: Serum IGF-1 monitoring
Danish: Serum-IGF-1-monitorering
English: As part of your treatment you may be given other medicines.
Danish: Som en del af din behandling får du muligvis andre lægemidler.
English: Things you need
Danish: Dette har du brug for
English: • Blood in the urine.
Danish: • Blod i urinen.
English: • If the decision is to treat, LTs and clinical symptoms should be monitored very closely.
Danish: • Hvis det besluttes at behandle, bør LTs og kliniske symptomer monitoreres nøje.
English: Upon re-administration, symptoms did not re-occur in all patients.
Danish: Ved readministration vendte symptomerne ikke tilbage hos alle patienter.
English: What should I do if I have any doubts about my medicine?
Danish: Hvad gør jeg, hvis jeg er i tvivl om noget vedrørende lægemidlet?
English: The clinical significance of these antibodies is unknown.
Danish: Den kliniske betydning af disse antistoffer er ukendt.
English: These can be seen in the results of blood tests.
Danish: Disse kan ses ved blodprøvetagning.
English: 1/1,000 to <1/100 Not known (cannot be estimated from the available data)
Danish:  1/1.000 til < 1/100 Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: The apparent volume of distribution of pegvisomant is relatively small (7-12 L).
Danish: Pegvisomants tilsyneladende fordelingsvolumen er relativt lille (7-12 l).
English: • Choose a different location within an area for each injection.
Danish: • Vælg et nyt sted inden for hvert område til hver injektion.
English: SOMAVERT is injected under the skin.
Danish: SOMAVERT indsprøjtes under huden.
English: This medicine must be dissolved before use.
Danish: Dette lægemiddel skal opløses inden brug.
English: Renal clearance of pegvisomant is negligible and accounts for less than 1% of total body clearance.
Danish: Den renale clearance af pegvisomant er ubetydelig og udgør mindre end 1% af den totale clearance.
English: *produced in Escherichia coli cells by recombinant DNA technology.
Danish: *produceret i Escherichia coli-celler ved hjælp af rekombinant DNA-teknologi.
English: EU/1/02/240/001 10 mg 30 vials EU/1/02/240/002 15 mg 30 vials EU/1/02/240/004 20 mg 1 vial EU/1/02/240/003 20 mg 30 vials EU/1/02/240/009 25 mg 1 vial EU/1/02/240/010 25 mg 30 vials EU/1/02/240/011 30 mg 1 vial EU/1/02/240/012 30 mg 30 vials
Danish: EU/1/02/240/001 10 mg 30 hætteglas EU/1/02/240/002 15 mg 30 hætteglas EU/1/02/240/004 20 mg 1 hætteglas EU/1/02/240/003 20 mg 30 hætteglas EU/1/02/240/009 25 mg 1 hætteglas EU/1/02/240/010 25 mg 30 hætteglas EU/1/02/240/011 30 mg 1 hætteglas EU/1/02/240/012 30 mg 30 hætteglas
English: • Wash your hands with soap and water, and dry thoroughly.
Danish: • Vask dine hænder med vand og sæbe og tør dem grundigt.
English: The colour of the protective plastic cap is specific to the strength of the product.
Danish: Farven på plastik-beskyttelseslåget er specifik for lægemidlets styrke.
English: The injection can be self-administered or given by another person, for example your doctor or his/her assistant.
Danish: Indsprøjtningen kan gives af dig selv eller af en anden person, for eksempel din læge eller hans/hendes assistent.
English: Patients should be advised to use adequate contraception if necessary.
Danish: Patienterne bør om nødvendigt rådes til at anvende adækvat antikonception.
English: About 17% of patients will develop antibodies to growth hormone during treatment.
Danish: Omkring 17% af patienterne vil udvikle antistoffer mod væksthormoner under behandlingen.
English: • Perform a comprehensive hepatic workup, including serial LTs, to determine if and when serum levels return to normal.
Danish: • Foretag en omfattende hepatisk udredning, herunder serielle LTs, for at bestemme om og hvornår serumniveauerne vender tilbage til normalt niveau.
English: The therapeutic benefits of a reduction in IGF-I concentration which results in improvement of the patient's clinical condition could potentially increase fertility in female patients.
Danish: De terapeutiske fordele ved en reduktion af IGF-I-koncentrationen, som resulterer i en forbedring af patientens kliniske tilstand, kan muligvis øge fertiliteten hos kvindelige patienter.
English: The safety and efficacy of SOMAVERT in children aged 0 to 17 years have not been established.
Danish: Sikkerhed og effekt af SOMAVERT hos børn i alderen 0-17 år er ikke fastlagt.
English: In cases of overdose, administration of this medicine should be discontinued and not resumed until IGF-I levels return to within or above the normal range.
Danish: I tilfælde af overdosering bør administration af dette lægemiddel seponeres og bør ikke genoptages, før IGF-I-niveauerne igen er indenfor eller over det normale område.
English: Except for one segment II test in the rabbit, no other reproductive toxicity studies were conducted.
Danish: Med undtagelse af en segment II undersøgelse på kaniner, har der ikke været udført andre reproduktions-toksiske undersøgelser.
English: Adverse reactions are listed according to the following categories: Very common: 1/10
Danish: Bivirkninger bliver nævnt i overensstemmelse med følgende kategorier: Meget almindelig:
English: This gives your skin and the area under your skin time to recover from one injection before it receives another one in the same place.
Danish: Det vil give din hud og området under huden, tid til at komme sig efter en injektion, inden en ny injektion gives på samme sted.
English: Why can't I get all of the medicine out of the vial?
Danish: Hvorfor kan jeg ikke få al lægemiddel ud af hætteglasset?
English: This medicine contains less than 1 mg of sodium per dose i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mg natrium pr. dosis, dvs. den er i det væsentlige ”natriumfri”.
English: How many times can I safely insert the needle into the vial stopper?
Danish: Hvor mange gange kan jeg sikkert indføre kanylen i proppen på hætteglasset?
English: SOMAVERT should not be used during pregnancy unless clearly necessary (see section 4.4).
Danish: SOMAVERT bør ikke anvendes under graviditet, medmindre det er klart nødvendigt (se pkt.
English: The use of this medicine in combination with other medicinal products for the treatment of acromegaly has not been extensively investigated.
Danish: Brug af dette lægemiddel i kombination med anden medicin til behandling af akromegali er ikke blevet grundigt undersøgt.
English: However, monitor LTs monthly to determine if further increases occur.
Danish: LTs skal dog monitoreres månedligt for at bestemme, om der sker yderligere stigninger.
English: The mean extent of absorption of a subcutaneous dose was 57% relative to an intravenous dose.
Danish: Den gennemsnitlige absorptionsgrad for en subkutan dosis er 57% i forhold til en intravenøs dosis.
English: The development of isolated low-titre anti-growth hormone antibodies was observed in 16.9% of patients treated with pegvisomant.
Danish: Udviklingen af isolerede lav-titer antivæksthormonantistoffer blev observeret hos 16,9% af patienterne behandlet med pegvisomant.
English: All patients with these tumours should be carefully monitored in order to avoid any eventual progression in tumour size under treatment.
Danish: Alle patienter med disse tumorer bør omhyggeligt overvåges for at undgå eventuel progression af tumorens størrelse under behandlingen.
English: However, monitor LTs weekly to determine if further increases occur (see below).
Danish: LTs skal dog monitoreres ugentligt for at bestemme, om der sker yderligere stigninger (se nedenfor).
English: Dose adjustments should be based on serum IGF-I levels.
Danish: Dosisjusteringer bør baseres på serum-IGF-I-niveauer.
English: Do not inject a double dose to make up for forgotten individual doses.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Do not use SOMAVERT:
Danish: Brug ikke SOMAVERT:
English: (angioedema)
Danish: (angioødem)
English: The powder is white and the solvent is clear and colourless.
Danish: Pulveret er hvidt, og solvens er gennemsigtig og farveløs.
English: However, due to the marked pharmacological response in monkey, systemic exposures higher than those achieved in patients at therapeutic doses have not been studied.
Danish: På grund af det markante farmakologiske respons i aber, har systemisk eksponering, større end den opnået i patienter ved terapeutiske doser, imidlertid ikke været undersøgt.
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of acromegaly.
Danish: Behandlingen bør initieres under overvågning af en læge, der har erfaring med behandling af akromegali.
English: If you are unable to clean the stopper, do not use the vial.
Danish: Hvis du ikke kan rengøre proppen, må du ikke bruge hætteglasset.
English: Greater than 3 times ULN
Danish: Højere end 3x ULN
English: Note: You will hear a click when the needle guard has been locked.
Danish: Bemærk: Du hører et klik, når kanylebeskytteren låser på plads.
English: Approximately linear pharmacokinetics is observed at steady state in the population pharmacokinetic studies.
Danish: Tilnærmet lineær farmakokinetik er observeret ved steady-state i farmakokinetiske populationsundersøgelser.
English: If these test results are not normal, your doctor will discuss treatment options with you.
Danish: Hvis testresultaterne er normale, vil lægen fortælle dig, hvilke behandlingsmuligheder der er.
English: Treatment by pegvisomant does not reduce tumour size.
Danish: Behandling med pegvisomant reducerer ikke tumorens størrelse.
English: If you forget to give yourself an injection you should inject the next dose as soon as you remember and then continue to inject SOMAVERT as prescribed by your doctor.
Danish: Hvis du glemmer at give dig selv en indsprøjtning, skal du indsprøjte den næste dosis så snart du kommer i tanke om det og derefter fortsætte med at indsprøjte SOMAVERT, som ordineret af din læge.
English: After single subcutaneous pegvisomant administration no linearity is observed with rising doses of 10, 15 or 20 mg.
Danish: Efter en enkelt subkutan administration af pegvisomant er der ikke observeret nogen linearitet ved stigende doser af 10, 15 eller 20 mg.
English: • Allow the injection area to dry.
Danish: • Lad injektionsområdet tørre.
English: How can I prevent the medicine from foaming?
Danish: Hvordan forhindrer jeg, at lægemidlet skummer?
English: You should not breast-feed while taking SOMAVERT unless your doctor has discussed this with you.
Danish: Du må ikke amme, mens du tager SOMAVERT, med mindre din læge har talt med dig om dette.
English: 1/100 to <1/10
Danish:  1/100 til < 1/10
English: Absorption of pegvisomant following subcutaneous administration is slow and prolonged, and peak serum pegvisomant concentrations are not generally attained until 33-77 hours after administration.
Danish: Pegvisomants absorption efter subkutan administration er langsom og forlænget, og maksimale serumkoncentrationer af pegvisomant opnås generelt ikke før 33-77 timer efter administration.
English: The list below contains adverse reactions seen in clinical trials or that were spontaneously reported, classified by system organ class and frequency.
Danish: Listen nedenfor indeholder bivirkninger set i kliniske forsøg eller spontant indberettet, inddelt efter organklasse og frekvens.
English: Use immediately after reconstitution.
Danish: Anvendes umiddelbart efter rekonstitution.
English: Increased fertility
Danish: Øget fertilitet
English: There is limited experience of overdose with pegvisomant.
Danish: Der er begrænset erfaring med overdosering af pegvisomant.
English: • If LTs normalize (regardless of whether an alternative cause of the liver dysfunction is discovered), consider cautious reinitiation of therapy with SOMAVERT, with frequent LT monitoring.
Danish: • Hvis LTs normaliseres (uanset om der er fundet en alternativ årsag til leverdysfunktionen), overvej da forsigtig genoptagelse af behandling med SOMAVERT, med hyppig LT-monitorering.
English: Do not shake vigorously, as this might cause denaturation of the active substance.
Danish: Hætteglasset må ikke rystes kraftigt, da dette kan medføre denaturering af det aktive stof.
English: This leaflet was last revised in <{MM/YYYY}>.
Danish: Denne indlægsseddel blev senest ændret i {MM/ÅÅÅÅ}
English: In the one reported incident of acute overdose, where 80 mg/day was administered for 7 days, the patient experienced a slight increase in fatigue and dry mouth.
Danish: Ved den eneste rapporterede hændelse med akut overdosering, hvor der blev administreret 80 mg/dag i 7 dage, oplevede patienten en let forøget træthed og mundtørhed.
English: Non-clinical data revealed no special hazard for humans based on studies of repeated dose toxicity in rat and monkey.
Danish: Ikke-kliniske data viser ingen særlig risiko for mennesker vurderet ud fra forsøg ved gentagen dosistoksicitet hos rotter og aber.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger forsøg af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: Statistically significant differences from placebo (p<0.05) were observed for improvements in the total signs and symptoms score for all dose groups compared to placebo.
Danish: Der ses statistisk signifikante forskelle fra placebo (p0,05) i forbedring af totale symptomer for alle doseringsgrupper sammenlignet med placebo.
English: The detailed instructions on injection procedure provided at the end of this leaflet must be followed.
Danish: Du skal følge den detaljerede vejledning om indsprøjtningsproceduren, som findes sidst i denne indlægsseddel.
English: • Immediately perform a comprehensive hepatic workup.
Danish: • Foretag straks en omfattende hepatisk udredning.
English: Clinical data are too limited (one reported case) to draw any conclusion on the excretion of pegvisomant in human breast milk.
Danish: De kliniske data er for begrænsede (1 tilfælde) til, at der kan drages konklusioner, om pegvisomant udskilles i human mælk.
English: • Increased levels of substances that measure the function of the liver.
Danish: • Forhøjet indhold af stoffer man måler for at bedømme leverfunktionen.
English: The powder may take a few minutes to dissolve fully, so continue swirling the vial gently until the liquid is completely clear.
Danish: Det kan tage et par minutter, inden pulveret opløses fuldstændigt, og du skal derfor fortsætte med at rotere hætteglasset forsigtigt, indtil væsken er helt klar.
English: Growth hormone-secreting pituitary tumours may sometimes expand, causing serious complications (for example, visual field defects).
Danish: Væksthormonsecernerende hypofysetumorer kan sommetider vokse og forårsage alvorlige komplikationer (f.eks. synsfeltsdefekter).
English: - If you experience disturbed vision or headaches while using SOMAVERT you must contact your doctor immediately.
Danish: - Hvis du får synsforstyrrelser eller hovedpine, når du bruger SOMAVERT, skal du øjeblikkeligt kontakte din læge.
English: Two weeks after stopping treatment, leukocytosis and moderate bleeding from injection and vein puncture sites was observed which were considered possibly related to pegvisomant.
Danish: To uger efter behandlingens ophør, blev leucocytose og moderat blødning fra injektions- og venepunktursteder observeret, hvilket blev betragtet som muligvis relateret til pegvisomant.
English: This can cause discomfort and increases risk of skin damage and infection.
Danish: Dette kan gøre injektionen ubehagelig og øger risikoen for skader og betændelse i huden.
English: Acromegalic patients (n=112) have been treated in a 12-week, randomised, double-blind, multicentre study comparing placebo and pegvisomant.
Danish: Patienter med akromegali (n=112) blev behandlet i en 12 ugers randomiseret, dobbelt-blind, multicenterundersøgelse, hvor placebo og pegvisomant blev sammenlignet.
English: • All questions should be handled by a doctor, nurse or pharmacist familiar with SOMAVERT.
Danish: • Alle spørgsmål vedrørende lægemidlet skal rettes til en læge, sygeplejerske eller apotekspersonale, der er bekendt med SOMAVERT.
English: Pfizer Health AB Mariefredsvagen 37 645 41 Strängnäs Sweden
Danish: Pfizer Health AB Mariefredsvägen 37 645 41 Strängnäs Sverige
English: - Your doctor should also monitor your adenoma (benign tumour).
Danish: Lægen bør også følge udviklingen i dit adenom (godartet kræftsvulst).
English: The site of injection should be rotated daily to help prevent lipohypertrophy.
Danish: Injektionssted bør varieres dagligt for at forhindre lipohypertrofi.
English: Foam makes the medicine unusable.
Danish: Skum gør lægemidlet uanvendeligt.
English: Choose injection area
Danish: Vælg injektionsområde
English: • Do not treat with SOMAVERT until a comprehensive workup establishes the cause of the patient's liver dysfunction.
Danish: • Initier ikke behandling med SOMAVERT, før en omfattende udredning har fastslået årsagen til patientens leverdysfunktion.
English: The pharmacokinetics of pegvisomant are similar in normal healthy volunteers and acromegaly patients, although heavier individuals tend to have a higher total body clearance of pegvisomant than lighter individuals, and may thus require greater doses of pegvisomant.
Danish: Pegvisomants farmakokinetik er den samme hos normale raske frivillige forsøgspersoner og hos patienter med akromegali, selvom tungere personer har en tendens til en højere total clearance af pegvisomant end lettere personer, og derfor måske behøver større pegvisomantdoser.
English: Normal
Danish: Normale
English: A growth hormone deficient state may result from administration of this medicinal product, despite the presence of elevated serum growth hormone levels.
Danish: Der kan opstå en væksthormonmangeltilstand efter administration af dette lægemiddel på trods af forhøjede serumniveauer af væksthormon.
English: SOMAVERT contains sodium
Danish: SOMAVERT indeholder natrium
English: • Perform a comprehensive hepatic workup to discern if an alternative cause of liver dysfunction is present.
Danish: • Foretag en omfattende hepatisk udredning for at afgøre, om der er en alternativ årsag til leverdysfunktion til stede.
English: Draw off dose
Danish: Udtræk dosen
English: Somavert comes in a vial as a white block of powder.
Danish: SOMAVERT leveres i et hætteglas som en blok af hvidt pulver.
English: This is achieved by snapping it off.
Danish: Hætten fjernes ved at knække den af.
English: Dispose of the needle and syringe as instructed by your doctor, nurse or pharmacist and in accordance with local health and safety laws.
Danish: Bortskaf kanylen og injektionssprøjten som anvist af lægen, sygeplejersken eller apotekspersonalet og i overensstemmelse med lokale sundheds- og sikkerhedsregler.
English: Pegvisomant is not recommended during pregnancy (see section 4.6).
Danish: Pegvisomant anbefales ikke under graviditet (se pkt.
English: • Slowly pull back the plunger rod to withdraw as much medicine as possible from the vial.
Danish: • Træk langsomt stemplet tilbage for at udtrække så meget lægemiddel som muligt fra hætteglasset.
English: After injection
Danish: Efter indsprøjtning