FrancophonIA/ELRC3.0 huggingface dataset:
English: Halimatoz is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Danish: Halimatoz er indiceret til behandling af moderat til svær aktiv Crohns sygdom hos pædiatriske patienter (fra 6 år), som har haft utilstrækkeligt respons på konventionel behandling inklusive primær ernæringsbehandling og kortikosteroidbehandling og/eller immunmodulerende behandling, eller som er intolerante over for eller har kontraindikationer mod sådanne behandlinger.
English: The recommended dose of Halimatoz for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Danish: Den anbefalede dosis af Halimatoz til patienter med ankyloserende spondylitis, aksial spondyloartritis uden radiografiske tegn på AS og til patienter med psoriasisartrit er 40 mg adalimumab givet som enkeltdosis subkutan injektion hver anden uge.
English: Halimatoz dose for paediatric patients with plaque psoriasis Patient weight
Danish: Halimatoz-dosis til pædiatriske patienter med plaque-psoriasis Patientvægt
English: Halimatoz is used in adults to treat these conditions.
Danish: Halimatoz bruges til at behandle disse sygdomme hos voksne.
English: Halimatoz 40 mg solution for injection in a single-use pre-filled syringe Halimatoz is supplied in a single-use clear type I glass syringe with a rubber stopper and a stainless steel needle with an automatic needle guard with finger flange, rubber needle cap and plastic plunger, containing 0.8 ml solution.
Danish: Halimatoz, 40 mg injektionsvæske, opløsning i fyldt engangssprøjte Halimatoz leveres i fyldt type 1-glas engangssprøjte med gummiprop og en kanyle i rustfrit stål med en automatisk beskyttelseshætte med fingerstøtte, kanylehætte i gummi og plastikstempel med 0,8 ml injektionsvæske.
English: Halimatoz is indicated for treatment of moderately to severely active Crohn's disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Danish: Halimatoz er indiceret til behandling af moderat til svær aktiv Crohns sygdom hos voksne patienter, som på trods af et fuldt og adækvat behandlingsforløb med kortikosteroid og/eller immunsuppressivum ikke har responderet tilfredsstillende, eller som er intolerante over for eller har kontraindikationer mod sådanne behandlinger.
English: Multipack cartons contain 6 (3 packs of 2) pre-filled pens of Halimatoz.
Danish: Multipakninger indeholder 6 (3 pakninger a 2) fyldte penne med Halimatoz.
English: Halimatoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Danish: Halimatoz er indiceret til behandling af aktiv entesopatirelateret artrit hos patienter fra 6 år, som har haft et utilstrækkeligt respons på, eller som er intolerante over for konventionel behandling (se pkt.
English: The recommended Halimatoz dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (table 3).
Danish: Den anbefalede Halimatoz-dosis til patienter med plaque-psoriasis fra 4 til 17 år er baseret på legemsvægt (tabel 3).
English: Cartons contain 1 and 2 pre-filled syringes of Halimatoz.
Danish: Pakningerne indeholder 1 og 2 fyldte injektionssprøjter med Halimatoz.
English: If these medicines do not work well enough, you will be given Halimatoz to reduce the signs and symptoms of your disease.
Danish: Hvis denne anden medicin ikke virker godt nok, kan du få Halimatoz for at mindske symptomerne på din sygdom.
English: Halimatoz is only available as 40 mg pre-filled syringe and 40 mg pre-filled pen.
Danish: Halimatoz er kun tilgængelig som 40 mg fyldt injektionssprøjte og 40 mg fyldt pen.
English: EU/1/18/1288/001 1 pre-filled syringe EU/1/18/1288/002 2 pre-filled syringes
Danish: EU/1/18/1288/001 1 fyldt injektionssprøjte EU/1/18/1288/002 2 fyldte injektionssprøjter
English: Halimatoz is administered by injection under the skin (by subcutaneous injection).
Danish: Halimatoz indgives ved injektion under huden (subkutan injektion).
English: Neurologic evaluation should be performed in patients with noninfectious intermediate uveitis prior to the initiation of Halimatoz therapy and regularly during treatment to assess for pre-existing or developing central demyelinating disorders.
Danish: Før initiering af Halimatoz og regelmæssigt under behandlingen bør der foretages en neurologisk udredning for at vurdere allerede eksisterende eller udvikling af demyeliniserende sygdomme hos patienter med non-infektiøs intermediær uveitis.
English: Multipack cartons contain 6 (3 packs of 2) pre-filled syringes of Halimatoz.
Danish: Multipakninger indeholder 6 (3 pakninger a 2) fyldte injektionssprøjter med Halimatoz.
English: Systemic infections (including sepsis, candidiasis and influenza), intestinal infections (including gastroenteritis viral), skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), ear infections, oral infections (including herpes simplex, oral herpes and tooth infections), reproductive tract infections (including vulvovaginal mycotic infection), urinary tract infections (including pyelonephritis), fungal infections, joint infections
Danish: Bivirkning øreinfektioner, orale infektioner (inklusive herpes simplex, oral herpes og tandinfektioner), infektioner i reproduktionsvejene (inklusive vulvovaginal svampeinfektion), urinvejsinfektioner (inklusive pylonephritis), svampeinfektioner, ledinfektioner Ikke almindelig Neurologiske infektioner (inklusive viral meningitis), opportunistiske infektioner og tuberkulose (inklusive kokcidioidomycose, histoplasmose og mycobakterium avium complex-infektion), bakterielle infektioner, øjeninfektioner, diverticulitis1)
English: You should not take Halimatoz with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection.
Danish: På grund af øget risiko for alvorlig infektion, må du ikke tage Halimatoz sammen med medicin, der indeholder de aktive stoffer anakinra eller abatacept.
English: Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), autoantibody test positive (including double stranded DNA antibody), blood lactate dehydrogenase increased
Danish: Positiv auto-antistoftest (inklusive dobbeltstrenget DNA-antistof), forhøjet
English: Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg adalimumab given every other week as a single dose.
Danish: Den almindelige dosis til voksne med reumatoid artrit, ankyloserende spondylitis, aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis og til patienter med psoriasisartrit er 40 mg adalimumab hver anden uge som enkeltdosis.
English: The recommended dose of Halimatoz for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (table 1).
Danish: Den anbefalede Halimatoz-dosis til patienter fra 2 år med polyartikulær juvenil idiopatisk artrit er baseret på legemsvægt (tabel 1).
English: Halimatoz is administered by subcutaneous injection.
Danish: Halimatoz administreres ved subkutan injektion.
English: Halimatoz 40 mg solution for injection (injection) in pre-filled pen is supplied as a 0.8 ml clear to slightly opalescent, colourless to slightly yellowish solution.
Danish: Halimatoz 40 mg injektionsvæske, opløsning (injektion) i fyldt pen leveres som en 0,8 ml klar til lettere opaliserende, farveløs til let gullig injektionsvæske.
English: Halimatoz is supplied in a single-use clear type I glass syringe with a stainless steel needle with a needle guard with finger flange, rubber needle cap and plastic plunger rod, containing 0.8 ml of solution.
Danish: Halimatoz leveres i en type 1-glas-engangssprøjte med en kanyle i rustfrit stål med en kanylebeskyttelse med fingerstøtte, kanylehætte i gummi og plastikstempel med 0,8 ml injektionsvæske.
English: There is no relevant use of Halimatoz in children aged less than 2 years in this indication.
Danish: Det er ikke relevant at bruge Halimatoz til patienter under 2 år til denne indikation.
English: Halimatoz 40 mg solution for injection in pre-filled syringe Halimatoz 40 mg solution for injection in pre-filled pen
Danish: Halimatoz 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte Halimatoz 40 mg injektionsvæske, opløsning i fyldt pen
English: Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Halimatoz (see section 4.4).
Danish: Før initiering af behandling med Halimatoz rådes øjenlæger til at rådføre sig med en passende specialist (se pkt.
English: Some patients who experience decrease in their response to Halimatoz 40 mg every other week may benefit from an increase in dosage to 40 mg Halimatoz every week or 80 mg every other week.
Danish: Nogle patienter, som oplever, at deres respons på Halimatoz 40 mg hver anden uge bliver dårligere, kan have fordel af at øge dosis til 40 mg Halimatoz hver uge eller 80 mg hver anden uge.
English: Package leaflet: Information for the patient Halimatoz 40 mg solution for injection in pre-filled pen adalimumab
Danish: Indlægsseddel: Information til brugeren Halimatoz 40 mg injektionsvæske, opløsning i fyldt pen
English: Halimatoz 40 mg solution for injection (injection) in pre-filled syringe is supplied as a 0.8 ml clear to slightly opalescent, colourless to slightly yellowish solution.
Danish: Halimatoz 40 mg injektionsvæske, opløsning (injektion) i fyldt injektionssprøjte leveres som en 0,8 ml klar til lettere opaliserende, farveløs til let gullig injektionsvæske.
English: The recommended dose of Halimatoz for paediatric patients with uveitis from 2 years of age is based on body weight (table 5).
Danish: Den anbefalede Halimatoz-dosis til pædiatriske patienter med uveitis fra 2 år er baseret på legemsvægt (tabel 5).
English: The recommended dose of Halimatoz for patients with enthesitis-related arthritis from 6 years of age is based on body weight (table 2).
Danish: Den anbefalede Halimatoz-dosis til patienter fra 6 år med entesopatirelateret artrit er baseret på legemsvægt (tabel 2).
English: Halimatoz is used to treat psoriatic arthritis in adults.
Danish: Halimatoz bruges til at behandle psoriasisartrit hos voksne.
English: In monotherapy, some patients who experience a decrease in their response to Halimatoz 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Danish: Ved behandling med Halimatoz alene kan det være en fordel for visse patienter, der oplever faldende respons på Halimatoz 40 mg hver anden uge, at øge dosis til 40 mg adalimumab hver uge eller 80 mg hver anden uge.
English: The recommended Halimatoz induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Danish: Det anbefalede Halimatoz dosis-induktionsregime til voksne patienter med moderat til svær colitis ulcerosa er 160 mg i uge 0 (givet som fire 40 mg injektioner på en dag eller som to 40 mg injektioner pr. dag i to på hinanden følgende dage) og 80 mg i uge 2 (givet som to 40 mg injektioner på en dag).
English: The recommended Halimatoz dose is 80 mg at week 0 followed by 40 mg every other week starting at week 1 via subcutaneous injection.
Danish: Den anbefalede Halimatoz-dosis er 80 mg subkutant i uge 0, efterfulgt af 40 mg subkutant hver anden uge med start 1 uge efter den første dosis.
English: Halimatoz 40 mg injection adalimumab
Danish: Halimatoz 40 mg injektion adalimumab s.c.
English: The recommended Halimatoz dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day).
Danish: Det anbefalede Halimatoz dosisregime til voksne patienter med hidrosadenitis suppurativa (HS) er 160 mg på dag 1 (givet som fire injektioner af 40 mg på en dag eller som to injektioner af 40 mg pr. dag i to på hinanden følgende dage), efterfulgt af 80 mg to uger senere på dag 15 (givet som to injektioner af 40 mg på en dag).
English: In Figure A, the pen is shown with the cap removed.
Danish: Figur A: Delene i Halimatoz SensoReady pen I Figur A er pennen vist med hætten fjernet.
English: The recommended dose of Halimatoz for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Danish: Den anbefalede Halimatoz-dosis til voksne patienter med uveitis er en startdosis på 80 mg efterfulgt af 40 mg hver anden uge med start en uge efter den første dosis.
English: Consequently, Halimatoz can be used during breastfeeding..
Danish: Halimatoz kan som konsekvens heraf anvendes ved amning.
English: How to use Halimatoz
Danish: Sådan skal du tage Halimatoz
English: Beyond 16 weeks, patients with inadequate response to Halimatoz 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week.
Danish: Patienter med utilstrækkeligt respons på Halimatoz 40 mg hver anden uge efter 16 ugers behandling eller mere kan have fordel af en stigning i dosis til 40 mg hver uge eller 80 mg hver anden uge.
English: Discontinuation of Halimatoz therapy should be considered in patients with confirmed significant haematologic abnormalities.
Danish: Hos patienter med bekræftede signifikante hæmatologiske abnormiteter bør det overvejes at afbryde behandlingen med Halimatoz.
English: The recommended dose of Halimatoz for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Danish: Den anbefalede Halimatoz-dosis til voksne patienter er en startdosis på 80 mg subkutant, efterfulgt af 40 mg subkutant hver anden uge med start en uge efter den første dosis.
English: The recommended dose of Halimatoz is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting one week later.
Danish: Den anbefalede startdosis af Halimatoz er 80 mg (som to 40 mg injektioner på en dag), efterfulgt af 40 mg hver anden uge startende en uge efter den første dosis.
English: Halimatoz 40 mg solution for injection in pre-filled syringe adalimumab
Danish: Halimatoz 40 mg injektionsvæske, opløsning i fyldt sprøjte adalimumab
English: Halimatoz 40 mg solution for injection in pre-filled pen adalimumab
Danish: Halimatoz 40 mg injektionsvæske, opløsning i fyldt pen adalimumab
English: The usual Halimatoz dose for adults with ulcerative colitis is 160 mg initially (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), then 80 mg (as two 40 mg injections) two weeks later, and then 40 mg every other week.
Danish: Den anbefalede startdosis Halimatoz til voksne med colitis ulcerosa er 160 mg (som fire 40 mg injektioner på en dag eller to 40 mg injektioner pr. dag i to på hinanden følgende dage), derefter 80 mg (som to 40 mg injektioner) to uger senere, og herefter 40 mg hver anden uge.
English: − The other ingredients are adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid, sodium hydroxide and water for injections.
Danish: - Øvrige indholdsstoffer: adipinsyre, citronsyremonohydrat, natriumchlorid, mannitol,
English: Halimatoz dose for paediatric patients with uveitis Patient weight
Danish: Halimatoz-dosis til pædiatriske patienter med uveitis Patientvægt
English: What Halimatoz is and what it is used for What you need to know before you use Halimatoz How to use Halimatoz Possible side effects 5 How to store Halimatoz Contents of the pack and other information Instructions for use
Danish: Det skal du vide, før du begynder at tage Halimatoz Sådan skal du tage Halimatoz Bivirkninger
English: How should you store Halimatoz?
Danish: Sådan skal du opbevare Halimatoz:
English: If you use more Halimatoz than you should
Danish: Hvis du har taget for meget Halimatoz
English: 5 How to store Halimatoz Contents of the pack and other information Instructions for use
Danish: Pakningsstørrelser og yderligere oplysninger Brugsvejledning
English: Each syringe contains 40 mg/0.8 ml of Halimatoz.
Danish: Hver sprøjte indeholder 40 mg/0,8 ml
English: Each 0.8 ml single-dose pre-filled pen contains 40 mg of adalimumab.
Danish: Halimatoz 40 mg injektionsvæske, opløsning i fyldt pen Hver fyldt 0,8 ml enkeltdosis pen indeholder 40 mg adalimumab.
English: Long-term safety evaluations are ongoing.
Danish: Langsigtede sikkerhedsvurderinger pågår løbende.
English: 1 Up to 30 minutes are allowed for reconstitution
Danish: 1 Op til 30 minutter er tilladt til rekonstitution.
English: The reasons for this are not fully known and are possibly related to the mechanism of action.
Danish: Årsagerne dertil kendes ikke helt og er muligvis relateret til virkningsmekanismen.
English: and CD8
Danish: og CD8
English: Date of first authorisation: 22 May 2014 Date of latest renewal: 12 December 2018
Danish: Dato for første markedsføringstilladelse: 22. maj 2014 Dato for seneste fornyelse: 12. december 2018
English: There is insufficient information on what effect this may have on your baby.
Danish: Der er utilstrækkelige oplysninger om, hvilken virkning det kan have på dit barn.
English: Over time, there was no significant increase in the rate of serious infections.
Danish: Over tid var der ingen signifikant stigning i raten af alvorlige infektioner.
English: Entyvio may affect the way you respond to a vaccination.
Danish: Entyvio kan påvirke den måde, du reagerer på en vaccination på.
English: You must not be given Entyvio:
Danish: Du må ikke få Entyvio:
English: • if you are going to receive any vaccination or have recently had a vaccination.
Danish: • hvis du skal have en vaccination eller for nylig er blevet vaccineret.
English: Entyvio is used to treat the signs and symptoms in adults of:
Danish: Entyvio anvendes til at behandle tegn og symptomer hos voksne af:
English: Entyvio is not recommended for use in children or adolescents (under 18 years of age) due to the lack of information regarding the use of this medicine in this age group.
Danish: Entyvio anbefales ikke til børn og unge (under 18 år) på grund af manglende oplysninger om brugen af dette lægemiddel hos denne aldersgruppe.
English: Reconstituted and diluted solutions: Use immediately.
Danish: Rekonstituerede og fortyndede opløsninger: Anvendes omgående.
English: Some infections may become serious and possibly even life-threatening if left untreated.
Danish: Nogle infektioner kan blive alvorlige og muligvis endda livstruende, hvis de ikke behandles.
English: For more detailed information, see infusion and allergic reactions in section 4.
Danish: For nærmere oplysninger, se infusion og allergiske reaktioner i punkt 4.
English: If not fully dissolved after 20 minutes, allow another 10 minutes for dissolution.
Danish: Hvis det ikke er helt opløst efter 20 minutter, skal det stå endnu 10 minutter, indtil det er helt opløst.
English: If you do not respond well enough or are intolerant to these medicines, your doctor may give you Entyvio to reduce the signs and symptoms of your disease.
Danish: Hvis du ikke reagerer godt nok på eller er intolerant over for disse lægemidler, kan din læge give dig Entyvio for at reducere tegn og symptomer på sygdommen.
English: Other side effects that you may experience while taking Entyvio are listed below.
Danish: Andre bivirkninger, som du kan opleve, mens du får Entyvio, er anført nedenfor.
English: The majority of IRRs were mild or moderate in intensity and < 1% resulted in discontinuation of study treatment.
Danish: De fleste IRR'er var milde eller moderate i intensitet, og < 1 % resulterede i seponering af studiebehandlingen.
English: Your doctor may decide to alter this treatment schedule depending on how well Entyvio works for you.
Danish: Din læge kan beslutte at ændre denne behandlingsplan afhængigt af, hvor god effekt du har af Entyvio.
English: Patients should be monitored closely for infections before, during and after treatment.
Danish: Patienter bør monitoreres nøje for infektioner før, under og efter behandling.
English: No individual Preferred Term reported as an IRR occurred at a rate above 1%.
Danish: Ingen foretrukken term, rapporteret som en IRR, forekom ved en hyppighed over 1 %.
English: Appropriate monitoring and medical support measures should be available for immediate use when administering vedolizumab.
Danish: Passende overvågning og medicinske støtteforanstaltninger skal være tilgængelige til øjeblikkelig brug ved administration af vedolizumab.
English: Live and oral vaccines
Danish: Levende og orale vacciner
English: Exploratory analyses provide additional data on key subpopulations studied.
Danish: Eksploratoriske analyser giver yderligere data om de vigtigste subpopulationer, der er undersøgt.
English: The impact on other oral and nasal vaccines is unknown.
Danish: Virkningen på andre orale og nasale vacciner er ukendt.
English: It is to be reconstituted and further diluted prior to intravenous administration
Danish: Det skal rekonstitueres og yderligere fortyndes inden intravenøs administration.
English: All patients should be observed continuously during each infusion.
Danish: Alle patienter skal observeres kontinuerligt under hver infusion.
English: Induction of remission in Crohn's disease may take up to 14 weeks in some patients.
Danish: Induktion af remission af Crohns sygdom kan tage op til 14 uger hos nogle patienter.
English: Tell your doctor or nurse immediately when you first receive this medicine, during treatment, and between doses:
Danish: Fortæl det omgående til din læge eller sundhedspersonalet, når du første gang får dette lægemiddel, under behandlingen samt mellem doserne:
English: As noted in Table 4, although the primary endpoint was not met, exploratory analyses show that clinically meaningful results were observed.
Danish: Som nævnt i Tabel 4, selv om det primære endepunkt ikke blev opfyldt, viser eksploratoriske analyser, at der blev observeret klinisk betydningsfulde resultater.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/923/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/923/001
English: Administration of the influenza vaccine should be by injection in line with routine clinical practice.
Danish: Administration af influenzavaccine skal ske med injektion på linje med rutinemæssig klinisk praksis.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: These could occur during or after the infusion.
Danish: Disse reaktioner kan forekomme under eller efter infusionen.