FrancophonIA/ELRC3.0 huggingface dataset:
English: The HbA1c change for saxagliptin 5 mg plus metformin (n=31) compared to placebo plus metformin (n=15) was -0.8% at Week 102.
Danish: Ændringen i HbA1c for saxagliptin 5 mg + metformin (n=31) sammenlignet med placebo + metformin (n=15) var -0.8 % i uge 102.
English: Mean change
Danish: Gennemsnitlig ændring
English: printed on one side and “4214” printed on the other side, in blue ink.
Danish: Der er trykt ”2.5” på den ene side og ”4214” på den anden side med blåt tryk.
English: Abdominal pain† Common Common Common
Danish: Urinvejsinfektion Almindelig Almindelig Almindelig Almindelig Gastroenteritis
English: Musculoskeletal and connective tissue disorders Arthralgia
Danish: Knogler,led, muskler og bindevæv Artralgi
English: • Common, (may affect 1 to 10 users in 100): infection of the upper chest or lungs, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), inflamed nose or throat (nasopharyngitis) (signs of this may include a cold or a sore throat), headache, muscle pain (myalgia), vomiting, inflammation of the stomach (gastritis), stomach ache and indigestion (dyspepsia).
Danish: • Almindelig (kan forekomme hos 1 til 10 ud af 100 behandlede): Infektion i øvre bryst eller lunger, urinvejsinfektion, betændelse i mave eller tarm sædvanligvis forårsaget af en infektion (mave-tarm-katar), infektion af bihulerne med en følelse af smerte og hævelse bag kinder og øjne (sinusitis), betændelse i næse eller svælg (nasofaryngit) (symptomerne på dette kan inkludere forkølelse eller ondt i halsen), hovedpine, muskelsmerter (myalgi), opkastning, inflammation i maven (gastrit), mavepine og fordøjelsesbesvær (dyspepsi).
English: Onglyza 2.5 mg film-coated tablets Onglyza 5 mg film-coated tablets
Danish: Onglyza 2,5 mg filmovertrukne tabletter Onglyza 5 mg filmovertrukne tabletter
English: What Onglyza is and what it is used for What you need to know before you take Onglyza How to take Onglyza
Danish: Det skal du vide, før du begynder at tage Onglyza Sådan skal du tage Onglyza Bivirkninger
English: Saxagliptin significantly decreased HbA1c compared with placebo; the HbA1c change for saxagliptin was -0.9% at Week 12 (HbA1c change of -0.4% for placebo).
Danish: HbA1c-ændringen for saxagliptin var -0,9 % i uge 12 (ændringen i HbA1c var -0,4 % for placebo).
English: The HbA1c change for saxagliptin 5 mg (n=82) compared to TZD plus placebo (n=53) was -0.9% at Week 76.
Danish: HbA1c-ændringen for saxagliptin 5 mg (n=82) sammenlignet med TZD + placebo (n=53) var -0,9 % i uge 76.
English: Onglyza should not be used during pregnancy unless clearly necessary.
Danish: Onglyza må kun anvendes på tvingende indikation til gravide.
English: Some patients have had the following side effects while taking Onglyza and metformin and a sulphonylurea:
Danish: Nogle patienter har haft følgende bivirkninger, når de har taget Onglyza og metformin og et sulfonylurinstof:
English: The HbA1c change for saxagliptin 5 mg plus metformin (n=177) compared to metformin plus placebo (n=147) was -0.5% at Week 76.
Danish: HbA1c-ændringen for saxagliptin 5 mg + metformin (n=177) sammenlignet med metformin + placebo (n=147) var -0,5 % i uge 76.
English: Some patients have had the following side effects while taking Onglyza and a thiazolidinedione:
Danish: Nogle patienter har haft følgende bivirkninger mens de har taget Onglyza og et thiazolidindion:
English: In a pooled analysis of 1,681 patients with type 2 diabetes including 882 patients treated with Onglyza 5 mg, randomised in five double-blind, placebo-controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control, the overall incidence of adverse events in patients treated with saxagliptin 5 mg was similar to placebo.
Danish: Den samlede incidens af bivirkninger hos patienter behandlet med saxagliptin 5 mg var sammenlignelig med placebo i en poolet analyse af 1681 patienter med type 2-diabetes, herunder 882 patienter, der var behandlet med Onglyza 5 mg, som blev randomiseret i fem dobbeltblinde, placebokontrollerede kliniske sikkerheds- og virkningsstudier med henblik på at evaluere effekten af saxagliptin på den glykæmiske kontrol.
English: CALENDAR BLISTERS (NON-PERFORATED) for Onglyza 5 mg tablets
Danish: KALENDER BLISTRE (IKKE-PERFOREREDE) Onglyza 5 mg tabletter
English: BLISTERS (PERFORATED/NON-PERFORATED) for Onglyza 2.5 mg tablets
Danish: BLISTRE (PERFOREREDE/IKKE-PERFOREREDE) Onglyza 2,5 mg tabletter
English: BLISTERS (PERFORATED/NON-PERFORATED) for Onglyza 5 mg tablets
Danish: BLISTRE (PERFOREREDE/IKKE-PERFOREREDE) Onglyza 5 mg tabletter
English: Please 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 Onglyza Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: OUTER CARTON Onglyza 2.5 mg film-coated tablets
Danish: YDRE KARTON Onglyza 2,5 mg filmovertrukne tabletter
English: Pack sizes of 14, 28, 56 and 98 film-coated tablets in non-perforated blisters.
Danish: Pakningsstørrelser på 14, 28, 56 og 98 filmovertrukne tabletter i ikke-perforerede blistre.
English: An add-on placebo-controlled study of 24-week duration was conducted to evaluate the efficacy and safety of saxagliptin in combination with glibenclamide in patients with inadequate glycaemic control at enrollment (HbA1c 7.5-10%) on a sub-maximal dose of glibenclamide alone.
Danish: En placebokontrolleret undersøgelse af tillæg til metformin af 24-ugers varighed blev gennemført for at evaluere effekt og sikkerhed af saxagliptin i kombination med glibenclamid hos patienter med utilstrækkelig glykæmisk kontrol på indrulleringstidspunktet (HbA1c7,5-10 %) på en submaksimal dosis af glibenclamid alene.
English: CALENDAR BLISTERS (NON-PERFORATED) for Onglyza 2.5 mg tablets
Danish: KALENDER BLISTRE (IKKE-PERFOREREDE) Onglyza 2,5 mg tabletter
English: Pack sizes of 14, 28, and 98 film-coated tablets in non-perforated calendar blisters.
Danish: Pakningsstørrelser på 14, 28 og 98 filmovertrukne tabletter i ikke-perforerede kalenderblistre.
English: General disorders and administration site conditions Fatigue
Danish: Almene symptomer og reaktioner påadministrationssted et
English: Each film-coated tablet contains 5 mg saxagliptin (as hydrochloride).
Danish: Hver filmovertrukken tablet indeholder 5 mg saxagliptin (som hydrochlorid).
English: Each film-coated tablet contains 2.5 mg saxagliptin (as hydrochloride).
Danish: Hver filmovertrukken tablet indeholder 2,5 mg saxagliptin (som hydrochlorid).
English: An add-on to metformin placebo-controlled study of 24-week duration was conducted to evaluate the efficacy and safety of saxagliptin in combination with metformin in patients with inadequate glycaemic control (HbA1c 7-10%) on metformin alone.
Danish: En placebokontrolleret undersøgelse af tillæg til metformin af 24 ugers varighed blev udført for at vurdere effekt og sikkerhed af saxagliptin i kombination med metformin hos patienter med utilstrækkelig glykæmisk kontrol (HbA1c 7-10 %) på metformin alene.
English: Improvements in HbA1c, PPG, and FPG following treatment with saxagliptin 5 mg plus metformin were sustained up to Week 102.
Danish: Forbedringerne i HbA1c, PPG og FPG efter behandling med saxagliptin 5 mg + metformin blev opretholdt frem til uge 102.
English: Onglyza 5 mg film-coated tablets
Danish: Onglyza 5 mg filmovertrukne tabletter
English: OUTER CARTON Onglyza 5 mg film-coated tablets
Danish: YDRE KARTON Onglyza 5 mg filmovertrukne tabletter
English: See also section 5.1.
Danish: 5.1 og 5.2).
English: Improvements in HbA1c and PPG following treatment with saxagliptin 5 mg were sustained up to Week 76.
Danish: Forbedringerne i HbA1c og PPG efter behandling med saxagliptin 5 mg blev opretholdt frem til uge 76.
English: Onglyza 5 mg tablets saxagliptin
Danish: Onglyza 5 mg tabletter saxagliptin
English: • Common: infection of the upper chest or lungs, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), headache, vomiting, stomach ache and swelling of the hands, ankles or feet (peripheral oedema).
Danish: • Almindelig: Infektion af øvre bryst eller lunger, urinvejsinfektion, betændelse i mave eller tarm sædvanligvis forårsaget af en infektion (mave-tarm-katar), infektion af bihulerne med en følelse af smerte og hævelse bag kinder og øjne (sinusitis), hovedpine, mavepine og opkastning, hævelse af hænder, ankler eller fødder (perifere ødemer).
English: Dyslipidaemia
Danish: Hudlidelser
English: Onglyza 2.5 mg film-coated tablets
Danish: Onglyza 2,5 mg filmovertrukne tabletter
English: Pack sizes of 14, 28, 56 and 98 film-coated tablets in non-perforated calendar blisters.
Danish: Pakningsstørrelser på 14, 28, 56 og 98 filmovertrukne tabletter i ikke-perforerede kalenderblistre.
English: Onglyza 2.5 mg tablets saxagliptin
Danish: Onglyza 2,5 mg tabletter saxagliptin
English: Some patients have had the following side effects while taking Onglyza and a sulphonylurea:
Danish: Nogle patienter har haft følgende bivirkninger, mens de har taget Onglyza og et sulfonylurinstof:
English: Saxagliptin add-on to metformin therapy
Danish: Saxagliptin-tillæg til behandling med metformin
English: If you feel dizzy while taking Onglyza, do not drive or use any tools or machines.
Danish: Kør ikke bil eller motorcykel og lad være med at arbejde med værktøj eller maskiner, hvis du føler dig svimmel, når du tager Onglyza.
English: How to take Onglyza
Danish: Sådan skal du tage Onglyza
English: The HbA1c change for saxagliptin 5 mg (n=56) compared to uptitrated glibenclamide plus placebo (n=27) was -0.7% at Week 76.
Danish: HbA1cændringen for saxagliptin 5 mg (n=56) sammenlignet med optitreret glibenclamid + placebo (n=27) var -0,7 % i uge 76.
English: Improvements in HbA1c, PPG and FPG following initial therapy with saxagliptin 5 mg plus metformin were sustained up to Week 76.
Danish: Forbedringerne i HbA1c, PPG og FPG efter initial behandling med saxagliptin 5 mg + metformin blev opretholdt frem til uge 76.
English: Improvements in HbA1c, PPG and FPG following treatment with saxagliptin 5 mg were sustained up to Week 76.
Danish: Forbedringerne i HbA1c, PPG og FPG efter behandling med saxagliptin 5 mg blev opretholdt frem til uge 76.
English: The recommended dose of Onglyza is 5 mg once daily.
Danish: Den anbefalede dosis er 5 mg én gang dagligt.
English: • Common: infection of the upper chest or lungs, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), headache, stomach ache and vomiting.
Danish: • Almindelig: Infektion af øvre bryst eller lunger, urinvejsinfektion, betændelse i mave eller tarm sædvanligvis forårsaget af en infektion (mave-tarm-katar), infektion af bihulerne med en følelse af smerte og hævelse bag kinder og øjne (sinusitis), hovedpine, mavepine og opkastning.
English: Uncommon Uncommon Uncommon Uncommon
Danish: Linearitet/non-linearitet
English: Erectile dysfunction
Danish: Nedsat leverfunktion
English: A placebo-controlled study of 24-week duration was conducted to evaluate the efficacy and safety of saxagliptin in combination with a thiazolidinedione (TZD) in patients with inadequate glycaemic control (HbA1c 7-10.5%) on TZD alone.
Danish: Saxagliptin-tillæg til behandling med thiazolidindion Et placebokontrolleret studie af 24-ugers varighed blev gennemført for at evaluere effekt og sikkerhed af saxagliptin i kombination med et thiazolidindion (TZD) hos patienter med utilstrækkelig glykæmisk kontrol (HbA1c 7-10,5 %) på TZD alene.
English: They have “2.5”
Danish: 4.2 og 5.2).
English: Change from baseline (adjusted mean (95% Confidence interval [CI])
Danish: (95 % konfidensinterval [CI])
English: Primary composite endpoint: MACE Secondary composite endpoint: MACE plus All-cause mortality
Danish: MACE plus Total mortalitet
English: Onglyza 5 mg film-coated tablets Polyvinyl alcohol Macrogol 3350
Danish: Onglyza 5 mg filmovertrukne tabletter Polyvinylalkohol
English: Onglyza 5 mg film-coated tablets Saxagliptin
Danish: Onglyza 5 mg filmovertrukne tabletter Saxagliptin
English: Tablet core
Danish: Tabel 1
English: Onglyza 2.5 mg film-coated tablets Polyvinyl alcohol Macrogol 3350
Danish: Onglyza 2,5 mg filmovertrukne tabletter Polyvinylalkohol
English: Onglyza 2.5 mg film-coated tablets Saxagliptin
Danish: Onglyza 2,5 mg filmovertrukne tabletter saxagliptin
English: AstraZeneca AB Tel: +46 8 553 26 000
Danish: Tel: +46 8 553 26 000
English: l t o r
Danish: Pakningsstørrelse r
English: Current administrations:
Danish: Nuværende administrationer:
English: Date of first authorisation: 26/05/2016
Danish: Dato for første markedsføringstilladelse: 26/05/2016
English: • Reduce the signs and symptoms of your disease,
Danish: • Reducere tegn og symptomer på din sygdom
English: Write the new expiry date on the carton including day/month/year.
Danish: Skriv den ny udløbsdato på kartonen, herunder dag/måned/år.
English: 4 Median follow-up is based on patients treated.
Danish: 4 Medianopfølgning er baseret på behandlede patienter.
English: The new expiry date must be written on the carton.
Danish: Den nye udløbsdato skal skrives på kartonen.
English: The potential contribution of exposure to inflixumab and/or the severity of the underlying disease in these outcomes remains unclear.
Danish: Den potentielle indflydelse fra eksponering for infliximab og/eller sværhedsgraden af den underliggende sygdom i disse resultater er fortsat uklar.
English: In this situation, Flixabi should be re-initiated as a single dose followed by the maintenance dose recommendations described above.
Danish: I denne situation bør Flixabi initieres igen som en enkelt dosis efterfulgt af vedligeholdelsesdoser som anbefalet ovenfor.
English: This will depend on your disease, weight and how well you respond to Flixabi.
Danish: Dette vil afhænge af din sygdom, vægt og hvor godt, du reagerer på Flixabi.
English: Neurological events
Danish: Neurologiske hændelser
English: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Allow the reconstituted solution to stand for 5 minutes.
Danish: Lad den rekonstituerede opløsning stå i 5 minutter.
English: Foaming of the solution on reconstitution is not unusual.
Danish: Opskumning af opløsningen ved rekonstitution er ikke usædvanligt.
English: • You will be monitored while you are given Flixabi and also for 1 to 2 hours afterwards.
Danish: • Du vil blive overvåget, mens du får Flixabi og i 1-2 timer derefter.
English: Improvement from baseline in HAQ averaged over time from week 30 to week 54
Danish: Forbedring fra baseline i HAQ gennemsnitligt over tid fra uge 30 til uge 54c
English: Worsening of symptoms of dermatomyositis.
Danish: Forværring af dermatomyositis-symptomer.
English: Additional information on special populations
Danish: Yderligere information om særlige populationer
English: Table 9 Effects on ACR and PASI in IMPACT and IMPACT 2
Danish: Tabel 9 Effekt på ACR og PASI i IMPACT og IMPACT 2 IMPACT
English: Patients who did not respond to infliximab at week 8 (n=15) received no further medicinal product and returned for safety followup.
Danish: Patienter, der ikke havde responderet på infliximab i uge 8 (n = 15), fik ikke yderligere lægemiddel og gik tilbage til sikkerhedsopfølgning.
English: The interval between the last maintenance dose and the first reinduction dose ranged from 35-231 days.
Danish: Intervallet mellem den sidste vedligeholdelsesdosis og den første dosis ved gentagen induktion varierede mellem 35 og 231 dage.
English: Flixabi will be stored by the health professionals at the hospital or clinic.
Danish: Flixabi opbevares af sundhedspersonalet på hospitalet eller klinikken.
English: It should be noted that in the majority of these reports tuberculosis was extrapulmonary, presenting as either local or disseminated disease.
Danish: Det bør bemærkes, at der i størstedelen af disse tilfælde var tale om tuberkulose med ekstrapulmonal placering i form af enten lokal eller dissemineret sygdom.
English: • In some patients receiving infliximab, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
Danish: • Hos nogle patienter, som får infliximab, kan kroppen måske ikke lave nok af de blodlegemer, der skal hjælpe med at bekæmpe infektioner eller stoppe blødning.
English: Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier.
Danish: Kassér lægemidlet, hvis det ikke er anvendt ved den nye udløbsdato eller udløbsdatoen, der er trykt på kartonen, alt efter hvad der kommer først.
English: The majority of the malignancies developed in the lung or head and neck.
Danish: De fleste af de maligne sygdomme udvikledes i lungerne eller hoved og hals.
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: • Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: It should be noted that suppression of TNFα may mask symptoms of infection such as fever.
Danish: Vær opmærksom på, at suppression af TNFα kan maskere symptomer på infektion såsom feber.
English: • Severely decreased numbers of white blood cells have been reported in infants born to women treated with Flixabi during pregnancy.
Danish: • Alvorligt fald i antal hvide blodlegemer er set hos spædbørn født af kvinder, der er blevet behandlet med Flixabi under graviditeten.
English: Infliximab has been studied only in combination with conventional immunosuppressive therapy.
Danish: Infliximab er kun blevet undersøgt i kombination med konventionel immunsuppressiv behandling.
English: Do not use Flixabi if any of the above applies to you.
Danish: Du må ikke få Flixabi, hvis noget af ovenstående passer på dig.
English: • Your doctor or nurse will prepare the medicine for infusion.
Danish: • Din læge eller sygeplejerske vil klargøre medicinen til infusion, opløsningen.
English: Tachycardia, palpitation.
Danish: Takykardi, palpitation.
English: Infliximab crosses the placenta and has been detected in the serum of infants up to 6 months following birth.
Danish: Infliximab passerer placenta og er blevet påvist i serum hos spædbørn op til 6 måneder efter fødslen.
English: Flixabi belongs to a group of medicines called ‘TNF blockers'.
Danish: Flixabi tilhører en medicingruppe kaldet ”TNF-blokkere”.
English: Because human immunoglobulins are excreted in milk, women must not breast-feed for at least 6 months after Flixabi treatment.
Danish: Da humane immunglobuliner udskilles i mælk, må kvinder ikke amme i mindst 6 måneder efter Flixabibehandling.
English: Depression, insomnia.
Danish: Depression, søvnløshed.
English: ≥ 5 x ULN placebo infliximab placebo infliximab placebo infliximab placebo infliximab
Danish: ≥ 3 x ULN ≥ 5 x ULN placebo infliximab placebo Infliximab placebo infliximab placebo infliximab
English: The potential risk with the combination of AZA or 6-MP and Flixabi should be carefully considered.
Danish: Den potentielle risiko ved kombinationen af AZA eller 6-MP og Flixabi skal overvejes omhyggeligt.
English: Instructions for use and handling - storage conditions Store at 2°C - 8°C.
Danish: Instruktioner i anvendelse og håndtering - opbevaringsforhold Opbevares ved 2°C - 8°C.
English: • The doctor will decide your dose and how often you will be given Flixabi.
Danish: • Lægen vil bestemme din dosis og hvor ofte, du skal have Flixabi.
English: It is important that you and your doctor record the brand name and batch number of your medicine.
Danish: Det er vigtigt, at du og din læge noterer produktnavn og lotnummer på din medicin.
English: Upon removal from refrigerated storage, Flixabi must not be returned to refrigerated storage.
Danish: Efter udtagning fra opbevaring på køl må Flixabi ikke sættes tilbage til opbevaring på køl.
English: The moderate number of prospectively collected pregnancies exposed to infliximab resulting in live birth with known outcomes, including approximately 1100 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Danish: Det beskedne antal prospektivt indsamlede graviditeter eksponeret for infliximab, som resulterede i levendefødsel med kendte resultater, inklusive ca. 1100 graviditeter, der blev eksponeret under første trimester, indikerer ikke en stigning i hyppigheden af misdannelser hos den nyfødte.
English: Periodic screening should continue in women treated with infliximab, including those over 60 years of age.
Danish: Periodisk screening bør fortsætte hos kvinder, der er blevet behandlet med infliximab, inklusive kvinder over 60 år.
English: START was a randomised, multicentre, double-blind, 3-arm, parallel-group safety study.
Danish: START var et randomiseret, multicenter, dobbelblindt, 3-armet, parallel- gruppe sikkerhedsstudie.
English: If you feel tired, dizzy, or unwell after having Flixabi, do not drive or use any tools or machines.
Danish: Hvis du føler dig træt, svimmel eller utilpas efter at have fået Flixabi, må du ikke føre motorkøretøj eller betjene nogen form for værktøj eller maskiner.
English: If you forget or miss your Flixabi infusion If you forget or miss an appointment to receive Flixabi, make another appointment as soon as possible.
Danish: Hvis du har glemt eller kommer for sent til din Flixabi-infusion Hvis du glemmer eller kommer for sent til en aftale, hvor Flixabi gives, skal du lave en ny aftale så hurtigt som muligt.
English: Intravenous use <IV>
Danish: Intravenøs anvendelse <i.v.>
English: c HAQ = Health Assessment Questionnaire; greater values indicate less disability.
Danish: c HAQ = Health Assessment Questionnaire; højere værdier indikerer mindre handicap.
English: Flixabi is also used in adults and children 6 years of age or older for:
Danish: Flixabi bruges også til voksne og børn fra 6 år og opefter til behandling af:
English: Allergic respiratory symptom.
Danish: Allergiske luftvejssymptomer.
English: Cerebrovascular accidents in close temporal association with infusion.
Danish: Cerebrovaskulære hændelser i tæt tidsmæssig forbindelse med infusionen.
English:  adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
Danish: • voksne patienter med alvorlig, aktiv og progressiv sygdom, der ikke tidligere er behandlet med methotrexat eller andre DMARD.
English: Flixabi infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues.
Danish: Flixabi-infusioner skal administreres af kvalificeret sundhedspersonale, som er trænet i at detektere infusionsrelaterede problemer.
English: • Your blood not supplying enough oxygen to your body, circulation problems such as narrowing of a blood vessel
Danish: • Dit blod tilfører ikke nok ilt til kroppen, kredsløbsproblemer såsom indsnævring af et blodkar
English: Flixabi is a biosimilar medicinal product.
Danish: Flixabi er et biosimilært lægemiddel.
English: The safety and efficacy of readministration after an infliximab-free interval of more than 16 weeks has not been established.
Danish: Sikkerhed og virkning ved fornyet indgift efter en infliximab-fri periode på over 16 uger er ikke klarlagt.