FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of Vectibix has not been studied in patients with renal or hepatic impairment.
Danish: Sikkerheden ved Vectibix er ikke undersøgt hos patienter med nedsat nyre- eller leverfunktion.
English: If you develop acute or worsening redness and pain in the eye, increased eye watering, blurred vision and/or sensitivity to light, please tell your doctor or nurse immediately as you may need urgent treatment (see “Possible side effects” below).
Danish: Fortæl straks lægen eller en sygeplejerske, hvis De akut udvikler eller får forværring af rødmen og smerter i øjnene, øget tåreflåd, sløret syn og/eller lysfølsomhed, da De kan have brug for akut behandling (se ”Bivirkninger” nedenfor).
English: • as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Danish: • som monoterapi, når kemoterapi-regimer, der indeholder fluorpyrimidin, oxaliplatin og irinotecan, har fejlet.
English: Mutant KRAS (exon 2) population
Danish: Muteret KRAS-population (exon 2)
English: Skin and subcutaneous tissue disorders1
Danish: Hud og subkutane væv1
English: Life-threatening and fatal infectious complications including necrotising fasciitis and sepsis have been observed in patients treated with Vectibix (see section 4.4).
Danish: Der er observeret livstruende og letale infektiøse komplikationer, herunder nekrotiserende fasciitis og sepsis, hos patienter, der blev behandlet med Vectibix (se pkt.
English: It is recommended that women do not breast-feed during treatment with Vectibix and for 2 months after the last dose.
Danish: Det anbefales, at kvinder ikke ammer under behandling med Vectibix og i 2 måneder efter den sidste dosis.
English: Severe (NCI-CTC grade 3) skin reactions were reported in 23% and life-threatening (NCI-CTC grade 4) skin reactions in < 1% of patients who received Vectibix monotherapy and in combination with chemotherapy (n = 2,224) (see section 4.8).
Danish: Alvorlige (NCI-CTC grad 3) hudreaktioner blev indberettet for 23 %, og livstruende (NCI-CTC grad 4) hudreaktioner for < 1 % af patienterne, som fik Vectibix som monoterapi kombineret med kemoterapi (n = 2.224) (se pkt.
English: Doses higher than 1,000 mg should be diluted in 150 mL sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: Doser, der er højere end 1.000 mg, skal fortyndes i 150 ml 9 mg/ml (0,9 %) natriumchloridinjektionsvæske, opløsning.
English: For patients whose sera tested positive in either screening immunoassay, an in vitro biological assay was performed to detect neutralising antibodies.
Danish: Med henblik på at påvise neutraliserende antistoffer blev der udført en biologisk analyse in vitro hos de patienter, som var testet positive i en af screenings-immunanalyserne.
English: Not recovered
Danish: Ikke svundet
English: In the post-marketing setting, rare cases of skin necrosis, Stevens-Johnson syndrome and toxic epidermal necrolysis (see section 4.4) have been reported.
Danish: Der er indberettet sjældne tilfælde af hudnekrose, Stevens-Johnsons syndrom og toksisk epidermal nekrolyse (se pkt.
English: When prepared according to the instructions given in section 6.6, the final panitumumab concentration should not exceed 10 mg/mL.
Danish: 6.6 bør den endelige panitumumab-koncentration ikke overstige 10 mg/ml.
English: Across monotherapy and combination mCRC clinical studies (n = 2,224), infusion-related reactions (occurring within 24 hours of any infusion), which may include symptoms/signs such as chills, fever or dyspnoea, were reported in approximately 5% of Vectibix-treated patients, of which 1% were severe (NCI-CTC grade 3 and grade 4).
Danish: På tværs af kliniske mCRC-studier med monoterapi og kombinationsbehandling (n = 2.224) blev der indberettet infusionsrelaterede reaktioner (opstået inden for 24 timer efter infusion), som kan omfatte symptomer/tegn såsom kulderystelser, feber eller dyspnø, hos cirka 5 % af de Vectibix-behandlede patienter.
English: If a severe or life-threatening reaction occurs during an infusion or at any time post-infusion [e.g. presence of bronchospasm, angioedema, hypotension, need for parenteral treatment, or anaphylaxis], Vectibix should be permanently discontinued (see sections 4.3 and 4.8).
Danish: Vectibix bør seponeres permanent, hvis en alvorlig eller livstruende reaktion opstår under en infusion eller når som helst efter en infusion (f.eks. bronkospasme, angioødem, hypotension, behov for parenteral behandling eller anafylaksi) (se pkt.
English: Results in patients with wild-type RAS mCRC and mutant RAS mCRC from the primary analysis are presented in the table below.
Danish: Resultaterne fra patienter med vildtype-RAS-mCRC og muteret RAS-mCRC fra den primære analyse vises i nedenstående tabel.
English: If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered.
Danish: Fordele og risici ved fortsat behandling skal overvejes nøje, hvis diagnosen keratitis stilles.
English: 20 mL of concentrate for solution for infusion.
Danish: 20 ml koncentrat til infusionsvæske, opløsning.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg of panitumumab.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 100 mg panitumumab.
English: Each vial contains 400 mg of panitumumab.
Danish: Hvert hætteglas indeholder 400 mg panitumumab.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Danish: INFORMATION I BRAILLESKRIFT Fritaget fra krav om blindeskrift.
English: What Vectibix contains
Danish: Vectibix indeholder:
English: 1 See section “Description of selected adverse reactions” below 2 See section 4.4 Infusion-related reactions
Danish: 1 Se nedenstående afsnit "Beskrivelse af udvalgte bivirkninger" 2 Se pkt.
English: • growth of eyelashes; flow of tears (lacrimation increased); redness of the eye (ocular hyperaemia); dry eye; itchy eyes (eye pruritus); eye irritation; eyelid inflammation (blepharitis);
Danish: • vækst af øjenvipper, øget tåreflåd, røde øjne (okulær hyperæmi), øjentørhed, øjenkløe, øjenirritation, øjenlågsinflammation (blefarit)
English: For clinical management of skin reactions, including dose modification recommendations, see section 4.4.
Danish: 4.4 vedrørende håndtering af hudreaktioner, herunder anbefalinger vedrørende dosisændring.
English: Vectibix should be diluted in sodium chloride 9 mg/mL (0.9%) solution for injection by healthcare professional using aseptic technique.
Danish: Vectibix skal fortyndes med 9 mg/ml (0,9 %) natriumchloridinjektionsvæske, opløsning, af en læge eller sygeplejerske vha. aseptisk teknik.
English: Doses higher than 1,000 mg should be diluted in 150 mL sodium chloride 9 mg/mL (0.9%) solution for injection (see section 4.2).
Danish: Doser, der er højere end 1.000 mg, skal fortyndes i en 150 ml 9 mg/ml (0,9 %) natriumchloridinjektionsvæske, opløsning (se pkt.
English: It is not recommended to breast-feed your baby during treatment with Vectibix and for 2 months after the last dose.
Danish: Det anbefales, at De ikke ammer Deres barn under behandling med Vectibix og i 2 måneder efter den sidste dosis.
English: • extreme tiredness (fatigue); fever or high temperature (pyrexia); lack or loss of strength
Danish: • ekstrem træthed (udmattelse), feber eller forhøjet temperatur (pyreksi), mangel på eller tab af styrke (asteni), ophobning af væske i ekstremiteter (hævede arme/ben og hænder/fødder)
English: Based on your age (older than 65 years) or general health, your doctor will discuss with you your ability to tolerate taking Vectibix with your chemotherapy treatment.
Danish: Deres læge vil drøfte med Dem, om De kan tåle Vectibix samtidig med kemoterapi på baggrund af Deres alder (ældre end 65 år) eller Deres generelle helbred.
English: Skin exfoliation Exfoliative rash Dermatitis
Danish: Hudeksfoliation Eksfoliativt udslæt Dermatitis
English: Acetic acid, glacial (for pH-adjustment)
Danish: Iseddikesyre (til regulering af pH)
English: Vomiting Abdominal pain Stomatitis Constipation
Danish: Opkastning Abdominalsmerter Stomatitis Obstipation
English: Hypersensitivity reactions occurring more than 24 hours after infusion have also been reported in the post-marketing setting.
Danish: Der er efter markedsføring desuden indberettet overfølsomhedsreaktioner, som er opstået mere end 24 timer efter infusionen.
English: • dry mouth; indigestion (dyspepsia); rectal bleeding (rectal haemorrhage); lip inflammation (cheilitis); heartburn (gastroesophageal reflux);
Danish: • mundtørhed, fordøjelsesbesvær (dyspepsi), blødning fra endetarmen, læbebetændelse (cheilitis), halsbrand (gastroøsofageal refluks)
English: • eyelid irritation; chapped lips and/or dry lips; eye infection; eyelid infection; nasal dryness;
Danish: • øjenlågsirritation, sprukne læber og/eller tørre læber, øjeninfektion, øjenlågsinfektion,
English: Gastro-oesophageal reflux disease
Danish: Gastroøsofageal refluks
English: • severe skin reaction with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome);
Danish: • alvorlig hudreaktion med blærer på huden, i munden, øjnene samt på kønsorganer
English: Vectibix in combination with oxaliplatin-based chemotherapy in patients with mutant RAS mCRC or for whom RAS tumour status is unknown
Danish: Vectibix i kombination med oxaliplatin-baseret kemoterapi til patienter med muteret RAS-mCRC eller patienter, hvor RAS-tumorstatus er ukendt
English: Doses higher than 1,000 mg should be infused over approximately 90 minutes (for handling instructions, see section 6.6).
Danish: Doser, der er højere end 1.000 mg, bør infunderes over ca. 90 minutter (se pkt.
English: Dermatological reactions (including nail effects), observed in patients treated with Vectibix or other EGFR inhibitors, are known to be associated with the pharmacologic effects of therapy (with crossreference to sections 4.2 and 4.8).
Danish: De dermatologiske reaktioner (herunder neglebivirkninger), der er observeret hos patienter, som behandles med Vectibix eller andre EGFR-hæmmere, vides at være relateret til den farmakologiske virkning af behandlingen (med krydsreference til pkt.
English: • nail disorder; breaking of the nails (onychoclasis);
Danish: • neglesygdom, flækkede negle (onychoclasis)
English: ORR (%)
Danish: ORR (%) (95 % CI)
English: Patients with a history of severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Danish: Patienter med en anamnestisk alvorlig eller livstruende overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Mucosal inflammation Oedema peripheral
Danish: Slimhinde-inflammation Perifert ødem
English: • skin cell death (skin necrosis);
Danish: • død af hudceller (hudnekrose)
English: In women of childbearing potential, appropriate contraceptive measures must be used during treatment with Vectibix, and for 2 months following the last dose.
Danish: Kvinder i den fødedygtige alder skal anvende effektive antikonceptionsmidler under behandlingen med Vectibix og i 2 måneder efter den sidste dosis.
English: Efficacy results in patients with wild-type RAS mCRC and mutant RAS mCRC are shown in the below table.
Danish: Effektresultaterne hos patienter med vildtype-RAS-mCRC og muteret RAS-mCRC vises i nedenstående tabel.
English: loosening of the nails (onycholysis); ingrowing nail; excessive hair growth (hirsutism);
Danish: næsetørhed, løsning af neglene (onykolyse), nedgroede negle, kraftig hårvækst (hirsutisme)
English: Type I glass vial with an elastomeric stopper, aluminium seal and flip-off plastic cap. One vial contains either 100 mg of panitumumab in 5 mL, or 400 mg panitumumab in 20 mL of concentrate for solution for infusion.
Danish: Ét hætteglas indeholder enten 100 mg panitumumab i 5 ml eller 400 mg panitumumab i 20 ml koncentrat til infusionsvæske, opløsning.
English: NAME OF THE MEDICINAL PRODUCT Vectibix 20 mg/mL concentrate for solution for infusion.
Danish: LÆGEMIDLETS NAVN Vectibix 20 mg/ml koncentrat til infusionsvæske, opløsning.
English: Rare cases of Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in patients treated with Vectibix in the post-marketing setting.
Danish: Efter markedsføring af præparatet er der indberettet sjældne tilfælde af Stevens-Johnsons syndrom og toksisk epidermal nekrolyse hos patienter, der blev behandlet med Vectibix.
English: What Vectibix is and what it is used for What you need to know before you use Vectibix How to use Vectibix
Danish: Det skal De vide, før De begynder at bruge Vectibix Sådan skal De bruge Vectibix Bivirkninger
English: Results in patients with wild-type RAS mCRC and mutant RAS mCRC are presented in the table below.
Danish: Resultaterne fra patienter med vildtype-RAS-mCRC og muteret RAS-mCRC vises i nedenstående tabel.
English: Nail disorder
Danish: Fortyndet opløsning
English: Allergic reactions
Danish: Overfølsomhedsreaktioner
English: Skin toxicity
Danish: Okulær toksicitet
English: A shortened progression-free survival and overall survival time were observed in a clinical study in patients with mutant RAS tumours who received panitumumab and FOLFOX (see sections 4.4 and 5.1).
Danish: I et klinisk studie med patienter med tumorer med muteret RAS, der fik panitumumab og FOLFOX (se pkt.
English: Your doctor will check your blood levels of several substances such as magnesium, calcium and potassium in your blood before you start Vectibix treatment.
Danish: Før De får behandling med Vectibix, vil lægen kontrollere indholdet af bestemte stoffer i blodet, herunder magnesium, calcium og kalium.
English: Vectibix should not be administered in combination with bevacizumab containing chemotherapy (see sections 4.5 and 5.1).
Danish: Vectibix bør ikke indgives sammen med kemoterapi indeholdende bevacizumab (se pkt.
English: You may experience skin reactions or severe swelling and tissue damage, if these worsen or become intolerable please tell your doctor or nurse immediately.
Danish: Hvis disse forværres eller bliver utålelige, skal De straks informere Deres læge eller sygeplejerske herom.
English: Skin necrosis4
Danish: Hudnekrose4
English: A high incidence of severe diarrhoea was observed when panitumumab was administered in combination with IFL (see section 4.4), and increased toxicity and deaths were seen when panitumumab was combined with bevacizumab and chemotherapy (see sections 4.4 and 5.1).
Danish: 4.4), og der observeredes forøget toksicitet og forøget antal dødsfald, når panitumumab blev kombineret med bevacizumab og kemoterapi (se pkt.
English: Headache Dizziness
Danish: Hovedpine Svimmelhed
English: Dermatitis acneiform Rash
Danish: Dermatitis acneiform Udslæt
English: Hypertrichosis
Danish: Natriumacetattrihydrat
English: NAME OF THE MEDICINAL PRODUCT Vectibix 20 mg/mL concentrate for solution for infusion panitumumab
Danish: Vectibix 20 mg/ml koncentrat til infusionsvæske, opløsning panitumumab
English: Metabolism and nutrition disorders
Danish: Metabolisme og ernæring Hypokaliæmi Hypomagnesiæmi
English: The combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status is unknown.
Danish: Kombination af Vectibix og kemoterapi, der indeholder oxaliplatin, er kontraindiceret til patienter med mCRC med muteret RAS eller med ukendt RAS-status.
English: Using only a 21-gauge or smaller diameter hypodermic needle, withdraw the necessary amount of Vectibix for a dose of 6 mg/kg.
Danish: Udtag den nødvendige mængde Vectibix til en dosis på 6 mg/kg, men kun med anvendelse af en subkutan kanyle med en diameter på 21 gauge (G) eller derunder.
English: Dry skin
Danish: Aftøst sår
English: Vectibix plus FOLFOX (months) Median (95% CI)
Danish: Vectibix plus FOLFOX (mdr.)
English: • The incidence of binding antibodies (excluding predose and transient positive patients) was
Danish: • Hyppigheden af neutraliserende antistoffer (eksklusive patienter, der var positive inden dosering eller forbigående positive) var < 1 %;
English: FOLFIRI (months) Median (95% CI)
Danish: Median (95 % CI)
English: Interstitial lung disease3
Danish: Interstitiel lungesygdom3 Bronkospasme Næsetørhed
English: • keratitis (inflammation of the front part of the eye (cornea));
Danish: • keratitis (betændelse i øjets hornhinde)
English: The combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status is unknown (see section 4.4).
Danish: Kombinationen af Vectibix og kemoterapi, der indeholder oxaliplatin, er kontraindiceret til patienter med muteret RAS-mCRC og til patienter med mCRC med ukendt RAS-status (se pkt.
English: What Vectibix looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: If you experience any of these symptoms, you should notify your doctor immediately.
Danish: Fortæl det straks til lægen, hvis De får et eller flere af disse symptomer.
English: The combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status is unknown (see sections 4.3 and 5.1).
Danish: Kombination af Vectibix og kemoterapi, der indeholder oxaliplatin, er kontraindiceret hos patienter med muteret RAS-mCRC og hos patienter med mCRC, hvor RAS-status er ukendt (se pkt.
English: Localised infection
Danish: Psykiske forstyrrelser
English: Eye disorders
Danish: Øjenlågsirritation
English: Dyspepsia
Danish: Hudtørhed
English: Asthenia
Danish: Søvnløshed
English: < 1% as detected by the acid-dissociation ELISA and 3.8% as detected by the Biacore assay;
Danish: • Hyppigheden af bindende antistoffer (eksklusive patienter, der var positive inden dosering eller forbigående positive) var < 1 % påvist ved syredissociations-ELISA og 3,8 % påvist ved Biacore-analysen;
English: Adverse reactions
Danish: Hudreaktioner
English: • References to authoritative international guidelines relevant for uterine surveillance.
Danish: • Referencer til myndighedernes internationale guidelines, der er relevante for kontrol af uterus.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemslandene skal sikre, at alle betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet beskrevet herunder er implementeret:
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET DER SKAL IMPLEMENTERES AF MEDLEMSLANDENE
English: • The need to stop treatment with FABLYN and investigate when unexplained uterine bleeding
Danish: • Behovet for at stoppe behandlingen med FABLYN og foretage undersøgelse, hvis der opstår
English: • Based on the clinical trials, the morphologic changes caused by FABLYN are benign and do not require further investigation unless vaginal bleeding occurs.
Danish: • På baggrund af kliniske studier er de morfologiske forandringer, forårsaget af FABLYN,
English: SmPC, including contraindication of FABLYN in patients with active or past history of VTE.
Danish: • De anbefalede tiltag for at nedsætte risikoen for venøs tromboemboli baseret på produktresuméet, herunder kontraindikationen vedrørende patienter med aktiv eller tidligere
English: (Invented) name Strength Pharmaceutical form Route of administration
Danish: Styrke LægemiddelformAdministration Emballage
English: 28 x 1 tablets (calendar pack)
Danish: 28 x 1 tabletter (kalenderpakning)
English: 50 tablet
Danish: 100 x 1 tablets
English: 26 February 2015
Danish: 26 februar 2015
English: Pharmacovigilance Risk Assessment Committee
Danish: Udvalget for Risikovurdering inden for Lægemiddelvurdering
English: Adopted at the 9-12 February 2015 PRAC
Danish: Vedtaget 9.-12. februar 2015 PRAC
English: Endocrine disorders:
Danish: Endokrine sygdomme:
English: Following the variations of the marketing authorisations for these products, the MAH for any product with the same active substance should submit a respective variation application.
Danish: Efter ændring af markedsføringstilladelserne for disse produkter skal indehavere af markedsføringstilladelse for alle produkter med samme aktive stof indsende en tilsvarende ændringsansøgning.
English: Aripiprazole - Hyperprolactinaemia (EPITT no 18086)
Danish: Aripiprazol - Hyperprolaktinæmi (EPITT nr. 18086)
English: PRAC recommendations on signals for update of the product information EMA/PRAC/118045/2015
Danish: PRAC's anbefalinger om signaler til ajourføring af produktinformationen EMA/PRAC/149191/2015
English: In clinical trials for the approved indication(s) and post-marketing, both increase and decrease in serum prolactin as compared to baseline was observed with aripiprazole (section 5.1).
Danish: I de kliniske undersøgelser for de(n) godkendte indikation(er) og efter markedsføring er der med aripiprazol iagttaget både stigning og fald i serumprolaktin i forhold til baseline (pkt.
English: Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable.
Danish: Meget sjælden (forekommer hos færre end 1 person ud af 10 000) Utilpashed, forvirring eller svaghed, kvalme, nedsat appetit, irritabilitet.
English: Having considered the available evidence in EudraVigilance, the MAH's clinical trials and pharmacovigilance databases and the literature, the PRAC has agreed that the MAH of Abilify and Abilify Maintena should submit variations within 2 months, to amend the product information as described below (new text underlined).
Danish: Efter gennemgang af de foreliggende oplysninger i EudraVigilance, markedsføringstilladelsesindehaverens kliniske undersøgelser, databaser over lægemiddelovervågning samt litteraturen afgjorde PRAC, at indehaveren af markedsføringstilladelse for Abilify og Abilify Maintena inden 2 måneder skal indsende en ændringsansøgning med henblik på ændring af produktinformationen som beskrevet nedenfor (ny tekst understreget).
English: Having considered the available evidence the PRAC has agreed that the MAHs of amiodarone for intravenous administration should submit a variation within 2 months, to amend the product information as described below (new text underlined).
Danish: Efter gennemgang af de foreliggende oplysninger har PRAC vedtaget, at indehaverne af markedsføringstilladelse for amiodaron til intravenøs administration inden 2 måneder skal indsende en ansøgning om ændring af produktinformationen som beskrevet i det følgende (ny tekst er understreget).
English: In addition, the MAH should describe the data on hyper- and hypoprolactinaemia in the SmPCs' sections 5.1.
Danish: Desuden skal indehaveren af markedsføringstilladelse beskrive oplysningerne om hyper- og hypoprolaktinæmi i produktresuméets punkt 5.1.
English: Section 4: Possible side effects Uncommon side effects (may affect up to 1 in 100 people): Increased blood levels of the hormone prolactin.
Danish: Ikke almindelige bivirkninger (forekommer hos op til 1 ud af 100 behandlede): Øget indhold i blodet af hormonet prolaktin
English: Frequency ‘uncommon': Hyperprolactinaemia
Danish: Endokrine sygdomme “Ukendt” hyppighed: Hyperprolaktinæmi
English: Amiodarone - Syndrome of inappropriate antidiuretic hormone secretion (SIADH) (EPITT no 18091)
Danish: Amiodaron - SIADH (syndrom med uhensigtsmæssig produktion af antidiuretisk hormon) (EPITT nr. 18091)
English: This could be an illness called ‘syndrome of inappropriate anti-diuretic hormone secretion' (SIADH).
Danish: Årsagen kan være sygdommen SIADH (syndrom med uhensigtsmæssig produktion af antidiuretisk hormon).
English: Very rare: Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Danish: Meget sjælden: SIADH (syndrom med uhensigtsmæssig produktion af antidiuretisk hormon)
English: Summary of product characteristics (SmPC) Section 4.8:
Danish: Punkt 4.8 - Bivirkninger:
English: This compared with 61% and 65% of those given Humira.
Danish: Dette skal sammenholdes med 61 % og 65 % af dem, der fik Humira.
English: These packs will include information on the safety of the medicine.
Danish: Disse pakker skal indeholde oplysninger om lægemidlets sikkerhed.