FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare side effects (may affect up to 1 in 1,000 people):
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 patienter):
English: Second-line GIOTRIF significantly improved PFS and OS of patients with squamous NSCLC compared to erlotinib.
Danish: Andenlinjebehandling med Giotrif medførte signifikant forbedret PFS og OS for patienter med planocellulær NSCLC sammenlignet med erlotinib.
English: Includes Acne, Acne pustular, Dermatitis acneiform
Danish: Omfatter akne, pustuløs akne, akneiform dermatitis.
English: At the first signs of diarrhoea drink plenty of fluids.
Danish: Ved de første tegn på diarré skal du drikke rigeligt med væske og kontakte lægen med det samme.
English: Eye irritation or inflammation may occur (conjunctivitis/keratoconjunctivitis occurs commonly and keratitis uncommonly).
Danish: Der kan forekomme irritation eller inflammation i øjnene (inflammation i bindehinden/samtidig inflammation i hornhinden og bindehinden er almindeligt, inflammation i hornhinden er ikke almindeligt).
English: GIOTRIF significantly improved PFS and ORR in EGFR mutation positive patients compared to gefitinib.
Danish: Giotrif forbedrede signifikant PFS og OS hos EGFR-mutationspositive patienter sammenlignet med gefitinib.
English: Lactose monohydrate Cellulose, microcrystalline (E460) Silica, colloidal anhydrous (E551) Crospovidone (type A) Magnesium stearate (E470b)
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose (E460) Kolloid vandfri silica (E551) Crospovidon (type A) Magnesiumstearat (E470b)
English: Afatinib covalently binds to and irreversibly blocks signalling from all homo- and heterodimers formed by the ErbB family members EGFR (ErbB1), HER2 (ErbB2), ErbB3 and ErbB4.
Danish: ErbB-familiemedlemmerne EGFR (ErbB1), HER2 (ErbB2), ErbB3 og ErbB4.
English: - The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), colloidal anhydrous silica (E551), crospovidone type A, magnesium stearate (E470b), hypromellose (E464), macrogol 400, titanium dioxide (E171), talc (E553b), polysorbate 80 (E433), indigo carmine (E132) aluminium hydroxide.
Danish: - Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose (E460), kolloid vandfri silica (E551), crospovidon type A, magnesiumstearat (E470b), hypromellose (E464), macrogol 400, titandioxid (E171), talcum (E553b), polysorbat 80 (E433), indigotin (E132)aluminiumhydroxid.
English: The efficacy and safety of GIOTRIF in Asian patients with Stage IIIB/IV EGFR mutation-positive locally advanced or metastatic adenocarcinoma of the lung was evaluated in a randomised, multicentre, open-label trial.
Danish: Giotrifs virkning og sikkerhed hos asiatiske patienter med stadium IIIB/IV EGFR-mutationspositiv, lokalt fremskredent eller metastaserende adenokarcinom i lungen blev evalueret i et randomiseret, ikke-blindet multicenterforsøg.
English: Hazard Ratio/ Odds Ratio (95%CI)
Danish: Hazard ratio/ Oddsratio (95 %-CI)
English: Table 3: Very common ADRs in trial LUX-Lung 3
Danish: Tabel 3: Meget almindelige bivirkninger i LUX-Lung 3-forsøget
English: Table 11: Symptom outcomes for GIOTRIF vs. erlotinib in trial LUX-Lung 8 (EORTC QLQ-C30 & QLQ-LC13)
Danish: Tabel 11: Resultater for Giotrif vs. erlotinib for symptomer i LUX-Lung 8-studiet (EORTC QLQ-C30 & QLQ-LC13)
English: Recommended dosing
Danish: Anbefalet dosering
English: GIOTRIF has not been studied in patients with eGFR <15 mL/min/1.73m² or on dialysis.
Danish: Giotrif er ikke undersøgt hos patienter med eGFT < 15 ml/min/1,73 m2 eller patienter i dialyse.
English: GIOTRIF in patients with NSCLC of squamous histology
Danish: Giotrif hos patienter med planocellulær NSCLC
English: Includes Pruritus, Pruritus generalised
Danish: Omfatter kløe, generaliseret kløe.
English: Dermatitis acneiform Pruritus Dry skin
Danish: Akneiform dermatitis Tør hud
English: Your doctor may adjust (increase or decrease) your dose depending on how well you tolerate this medicine.
Danish: Lægen kan ændre din dosis (sætte den op eller ned).
English: Table 6: Efficacy results of GIOTRIF vs. pemetrexed/cisplatin (LUX-Lung 3) gemcitabine/cisplatin (LUX-Lung 6) (Independent review)
Danish: Tabel 6: Effektresultater for Giotrif vs.pemetrexed/cisplatin (LUX-Lung 3) og vs. gemcitabin/cisplatin (LUX-Lung 6) (uafhængig vurdering)
English: Patients with rare hereditary conditions of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Dette lægemiddel indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
English: The types of adverse reactions (ADRs) were generally associated with the EGFR inhibitory mode of action of afatinib.
Danish: Generelt var typen af bivirkninger relateret til afatinibs virkningsmekanisme i form af hæmning af EGFR.
English: Odds Ratio (OR) (95%CI) p-value
Danish: Oddsratio (OR) (95 % CI) p-værdi
English: When to take GIOTRIF
Danish: Hvornår skal du tage Giotrif
English: Table 8: Symptom outcomes for GIOTRIF vs. chemotherapy in trials LUX-Lung 3 and LUX-Lung 6 (EORTC QLQ-C30 & QLQ-LC13)
Danish: Tabel 8: Resultater for symptomer for Giotrif vs. kemoterapi i forsøgene LUX-Lung 3 og LUX-Lung 6 (EORTC QLQ-C30 og QLQ-LC13)
English: Progression-free survival Months (median) Hazard Ratio (HR) (95%CI) p-value
Danish: Progressionsfri overlevelse Måneder (median) Hazard ratio (HR) (95 % CI) p-værdi
English: In the first-line setting, the efficacy and safety of GIOTRIF in patients with EGFR mutation-positive locally advanced or metastatic NSCLC (stage IIIB or IV) were assessed in a global, randomised, multicentre, open-label trial.
Danish: I forbindelse med førstelinjebehandling blev Giotrifs virkning og sikkerhed hos patienter med EGFR-mutationspositiv, lokalt fremskreden eller metastaserende NSCLC (stadium IIIB eller IV) undersøgt i et globalt, randomiseret, ikke-blindet multicenterforsøg.
English: ® 40 mg orally once daily (N=160) or gefitinib 250 mg orally once daily (N=159).
Danish: Patienterne (N = 319) blev randomiseret (1:1) til at få oral Giotrif 40 mg én gang daglig (N = 160) eller oral gefitinib 250 mg én gang daglig (N = 159).
English: - The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), colloidal anhydrous silica (E551), crospovidone type A, magnesium stearate (E470b), hypromellose (E464), macrogol 400,
Danish: - Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose (E460), kolloid vandfri silica (E551), crospovidon type A, magnesiumstearat (E470b), hypromellose (E464), macrogol
English: In general, rash manifests as a mild or moderate erythematous and acneiform rash, which may occur or worsen in areas exposed to sun. For patients who are exposed to sun, protective clothing, and use of sun screen is advisable.
Danish: Som regel manifesterer et udslæt sig som et let eller moderat erytematøst og aknelignende udslæt, der kan opstå eller blive forværret på områder udsat for sollys.
English: Patients with severe skin reactions may also require temporary interruption of therapy, dose reduction (see section 4.2), additional therapeutic intervention, and referral to a specialist with expertise in managing these dermatologic effects.
Danish: 4.2), yderligere terapeutisk intervention og henvisning til en specialist med erfaring i behandling af disse dermatologiske bivirkninger.
English: There have been reports of ILD or ILD-like adverse reactions (such as lung infiltration, pneumonitis, acute respiratory distress syndrome, allergic alveolitis), including fatalities, in patients receiving GIOTRIF for treatment of NSCLC.
Danish: Hos patienter, der fik Giotrif til behandling af NSCLC, har der været rapporter om ILD eller ILD-lignende bivirkninger (som f.eks. lungeinfiltrat, pneumonitis, akut respiratorisk distress syndrom, allergisk alveolitis), herunder tilfælde med dødelig udgang.
English: ®: EGFR29 Mutation Kit (Qiagen Manchester Ltd).
Danish: ®: EGFR29 Mutation Kit, (Qiagen
English: Grade 1 or Grade 2
Danish: Grad 1 eller grad 2
English: Renal impairment/ Renal failure
Danish: Nedsat nyrefunktion/ nyreinsufficiens
English: Gemcitabine/ Cisplatin (N=122)
Danish: Gemcitabin/ cisplatin (N=122)
English: Alive at 12 months Alive at 18 months
Danish: I live efter 18 mdr.
English: Stevens-Johnson syndrome Toxic epidermal necrolysis
Danish: Stevens-Johnsons syndrom
English: No starting dose adjustments appear necessary in patients with mild or moderate hepatic impairment (see section 4.2).
Danish: Det synes ikke at være nødvendigt at justere startdosis til patienter med let eller moderat nedsat leverfunktion (se pkt.
English: This medicinal product has not been studied in patients with severe (Child Pugh C) hepatic impairment.
Danish: Giotrif er ikke undersøgt hos patienter med svært (Child-Pugh C) nedsat leverfunktion.
English: Gastrointestinal disorders Diarrhoea Stomatitis
Danish: Mave-tarm-kanalen Diarré Stomatitis
English: Overall Survival (OS) Months (median) Hazard Ratio (HR) (95%CI) p-value
Danish: Samlet overlevelse (OS) Måneder (median) Hazard ratio (HR) (95 % CI) p-værdi
English: • Bleeding from the nose
Danish: • Næseblod
English: Hazard Ratio (HR) (95%CI) p-value p-value for PFS/OS based on stratified log-rank test
Danish: Samlet overlevelse (OS) Måneder (median) Hazard ratio (HR) (95 % CI) p-værdi p-værdi for PFS/OS baseret på stratificeret log-rank test
English: GIOTRIF treatment in patients with eGFR <15 mL/min/1.73m² or on dialysis is not recommended.
Danish: Behandling med Giotrif frarådes hos patienter med eGFR < 15 ml/min/1,73 m2 og patienter i dialyse.
English: Rash/acne has been reported in patients treated with this medicinal product (see section 4.8).
Danish: Der er rapporteret om udslæt/akne hos patienter behandlet med dette lægemiddel (se pkt.
English: Respiratory, thoracic and mediastinal disorders Rhinorrhoea
Danish: Luftveje, thorax og mediastinum Rinoré
English: Each blister is packed together with a desiccant sachet in a laminated aluminium pouch and contains 7 x 1 film-coated tablets.
Danish: Hvert blisterkort indeholder 7 x 1 filmovertrukne tabletter og er pakket i en lamineret foliepose sammen med en pose tørremiddel.
English: During treatment, ocular adverse reactions (conjunctivitis, dry eye, keratitis) have been reported in some patients (see section 4.8) which may affect patients ability to drive or use machines.
Danish: Under behandlingen er der rapporteret om øjenbivirkninger (conjunctivitis, tørre øjne, keratitis) hos nogle patienter (se pkt.
English: How to take GIOTRIF
Danish: Sådan skal du tage Giotrif
English: P-glycoprotein (P-gp) interactions Concomitant treatment with strong inducers of P-gp may decrease exposure to afatinib (see section 4.5).
Danish: Samtidig behandling med kraftige P-gp-induktorer kan reducere eksponeringen for afatinib (se pkt.
English: • It is important to take this medicine without food
Danish: • Det er vigtigt, at du tager Giotrif uden mad
English: Includes Dermatitis acneiform, Acne
Danish: Omfatter akneiform dermatitis, akne.
English: Includes Stomatitis, Aphthous stomatitis, Mucosal inflammation, Mouth ulceration, Mucosal erosion Includes group of rash preferred terms
Danish: Omfatter stomatitis, aftøs stomatitis, slimhindeinflammation, ulceration i munden, erosion i mundslimhinden Omfatter gruppen af MedDRA-standardtermer for udslæt.
English: Paronychia
Danish: Paronykie
English: However, this medicinal product has not been studied in patients with abnormal left ventricular ejection fraction (LVEF) or those with significant cardiac history.
Danish: Ud fra de foreliggende data fra kliniske forsøg er der ikke noget, der tyder på, at Giotrif giver bivirkninger med hensyn til hjertets kontraktilitet, men det er ikke undersøgt hos patienter med abnorm venstre ventrikel uddrivningsfraktion (LVEF) eller hos patienter med en betydende hjerteanamnese.
English: Inform your doctor immediately while taking this medicine:
Danish: Når du tager dette lægemiddel, skal du kontakte lægen med det samme:
English: There were no Grade 3 ALT/AST elevations in patients with abnormal baseline liver tests in LUX-Lung 8 (see section 4.8).
Danish: I LUX-Lung 8 sås ingen grad 3-stigninger i ALAT/ASAT hos patienter med unormale leverfunktionsværdier ved baseline (se pkt.
English: Includes Hypokalaemia, Blood potassium decreased Includes Rhinorrhoea, Nasal inflammation
Danish: Omfatter rinoré, nasal inflammation.
English: Gemcitabine/ Cisplatin (N=62)
Danish: Gemcitabin/ cisplatin (N=62)
English: Gemcitabine/ Cisplatin (N=46)
Danish: Gemcitabin/ cisplatin (N=46)
English: Subjects with severe renal impairment (n=8; eGFR 15-29 mL/min/1.73m², according to the
Danish: Patienter med svært nedsat nyrefunktion (n = 8; eGFR 15-29 ml/min/1,73 m² iht.
English: Treatment with this medicinal product should be interrupted pending investigation of these symptoms.
Danish: Giotrif skal seponeres, indtil disse symptomer er blevet undersøgt.
English: Rash may occur or worsen in areas exposed to sun. Sun protection with protective clothing and sunscreen is recommended.
Danish: Solbeskyttelse med dækkende beklædning og solcreme anbefales.
English: Palmar-plantar erythrodysaesthesia syndrome
Danish: Palmoplantar erytrodysæstesi-syndrom Neglesygdomme
English: Includes Paronychia, Nail infection, Nail bed infection Includes Stomatitis, Aphthous stomatitis, Mucosal inflammation, Mouth ulceration, Oral mucosa erosion, Mucosal erosion, Mucosal ulceration
Danish: Omfatter stomatitis, aftøs stomatitis, slimhindeinflammation, ulceration i munden, erosion i mundslimhinden, slimhindeerosion, slimhindeulceration.
English: Hazard Ratio/ Odds Ratio (95%CI) p-value
Danish: Hazard ratio/ Oddsratio (95 %-CI) p-værdi
English: Includes Paronychia, Nail infection, Nail bed infection Includes Cystitis, Urinary tract infection
Danish: Omfatter paronykie, negleinfektion, neglelejeinfektion.
English: • Stomach pain, indigestion, heartburn
Danish: • Mavesmerter, problemer med fordøjelsen, halsbrand
English: This leaflet was last approved in {MM/YYYY} Other sources of information
Danish: Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ.
English: Contact your doctor as soon as possible if you suffer from any of the serious side effects listed below.
Danish: - Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: One film-coated tablet contains 294 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Én filmovertrukket tablet indeholder 294 mg lactose (som monohydrat).
English: Race had no effect on the pharmacokinetics of afatinib based on a population pharmacokinetic analysis, including patients of Asian, White, and Black racial groups.
Danish: En populationsfarmakokinetisk analyse, der omfattede asiatiske, hvide og sorte patienter, viste, at etnisk oprindelse ikke havde nogen indvirkning på afatinibs farmakokinetik.
English: Adjustments to the starting dose are not necessary in patients with mild (eGFR 60-89 mL/min/1.73m²), moderate (eGFR 30-59 mL/min/1.73m²) or severe (eGFR 15-29 mL/min/1.73m²) renal impairment.
Danish: Justering af startdosis er ikke nødvendig hos patienter med let nedsat nyrefunktion (eGFR 60-89 ml/min/1,73 m2), moderat nedsat nyrefunktion (eGFR
English: Weight decreased Includes Paronychia, Nail infection, Nail bed infection Includes Stomatitis, Aphthous stomatitis, Mucosal inflammation, Mouth ulceration, Oral mucosa erosion, Mucosal erosion, Mucosal ulceration Includes group of rash preferred terms Includes Acne, Acne pustular, Dermatitis acneiform Includes Pruritus, Pruritus generalised Includes Dry skin, Skin chapped Based on post-marketing experience Includes Nail disorder, Onycholysis, Nail toxicity, Onychoclasis, Ingrowing nail, Nail pitting, Onychomadesis, Nail discoloration, Nail dystrophy, Nail ridging, and Onychogryphosis
Danish: Omfatter neglesygdomme, onykolyse, negletoksicitet, onykoklase, nedgroede negle, neglepitting, onykomadese, misfarvede negle, negledystrofi, rillede negle og onykogrypose.
English: What you need to know before you take GIOTRIF
Danish: Det skal du vide, før du begynder at tage Giotrif Sådan skal du tage Giotrif Bivirkninger
English: Body weight Plasma exposure (AUCτ,ss) was increased by 26% for a 42 kg patient (2.5
Danish: Plasmaeksponeringen (AUCτ,ss) blev øget med 26 % hos en patient på 42 kg (2,5-percentilen) og reduceret med 22 % hos en patient på 95 kg (97,5-percentilen) sammenlignet med en patient på 62 kg (den mediane legemsvægt for patienterne i den samlede patientpopulation).
English: What GIOTRIF looks like and contents of the pack GIOTRIF 20 mg film-coated tablets are white to yellowish and round shaped.
Danish: Giotrif 20 mg filmovertrukne tabletter er hvide til gullige og runde.
English: What GIOTRIF looks like and contents of the pack GIOTRIF 50 mg film-coated tablets are dark blue and oval shaped.
Danish: Giotrif 50 mg filmovertrukne tabletter er mørkeblå og ovale.
English: One film-coated tablet contains 176 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på En filmovertrukket tablet indeholder 176 mg lactose (som monohydrat).
English: Skin and subcutaneous tissue disorders Rash
Danish: Hud og subkutane væv Udslæt
English: One film-coated tablet contains 118 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på En filmovertrukket tablet indeholder 118 mg lactose (som monohydrat).
English: • Inflammation of the lungs (uncommon, may affect up to 1 in 100 people) called “interstitial lung disease”.
Danish: • Inflammation (betændelseslignende tilstand) i lungerne (ikke almindeligt, kan forekomme hos op til 1 ud af 100 personer) kaldes for “interstitiel lungesygdom” Hvis du får åndenød eller pludselig forværring af åndenød, der måske er ledsaget af hoste eller feber, skal du fortælle det til lægen med det samme.
English: One film-coated tablet contains 235 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på En filmovertrukket tablet indeholder 235 mg lactose (som monohydrat).
English: Progression-free survival
Danish: MedDRA-standardterm
English: GIOTRIF 20 mg film-coated tablets One film-coated tablet contains 20 mg afatinib (as dimaleate).
Danish: Giotrif 20 mg filmovertrukne tabletter En filmovertrukket tablet indeholder 20 mg afatinib (som dimaleat).
English: What GIOTRIF looks like and contents of the pack GIOTRIF 30 mg film-coated tablets are dark blue and round shaped.
Danish: Giotrif 30 mg filmovertrukne tabletter er mørkeblå og runde.
English: Gastrointestinal disorders Diarrhoea
Danish: Mave-tarm-kanalen Diarré
English: NCI Common Terminology Criteria for Adverse Events In case of diarrhoea, anti-diarrhoeal medicinal products (e.g. loperamide) should be taken immediately and continued for persistent diarrhoea until loose bowel movements cease.
Danish: I tilfælde af diarré skal der straks iværksættes behandling med midler mod diarré (f.eks. loperamid).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 20 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER FOLIEPOSE til 20 mg
English: White to yellowish, round, biconvex and bevel-edged film-coated tablet debossed with the code “T20” on one side and the Boehringer Ingelheim company logo on the other.
Danish: Hvid til gullig, rund, bikonveks og skråt afskåret filmovertrukket tablet præget med koden “T20” på den ene side og Boehringer Ingelheims firmalogo på den anden side.
English: • Mouth sores and inflammation
Danish: • Sår og irritation i munden
English: Dark blue, oval, biconvex film-coated tablet debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other.
Danish: Mørkeblå, oval, bikonveks filmovertrukket tablet præget med koden “T50” på den ene side og Boehringer Ingelheims firmalogo på den anden side.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 20 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PERFORERET BLISTER til 20 mg
English: What GIOTRIF looks like and contents of the pack GIOTRIF 40 mg film-coated tablets are light blue and round shaped.
Danish: Giotrif 40 mg filmovertrukne tabletter er lyseblå og runde.
English: GIOTRIF 20 mg film-coated tablets
Danish: Giotrif 20 mg filmovertrukne tabletter
English: Very common ADRs in GIOTRIF-treated patients occurring in at least 10% of patients in trial LUX-Lung 3 and LUX-Lung 7 are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Tables 3 and 4.
Danish: Tabel 3 og 4 giver en oversigt over meget almindelige bivirkninger, der forekom hos mindst 10 % af de Giotrif-behandlede patienter i LUX-Lung 3- og LUX-Lung 7-forsøgene.
English: GIOTRIF 30 mg film-coated tablets One film-coated tablet contains 30 mg afatinib (as dimaleate).
Danish: Giotrif 30 mg filmovertrukne tabletter En filmovertrukket tablet indeholder 30 mg afatinib (som dimaleat).
English: Subjects with moderate renal impairment (n=8; eGFR 30-59 mL/min/1.73m², according to the Modification of Diet in Renal Disease [MDRD] formula) had an exposure of 101% (Cmax) and 122% (AUC0-tz) in comparison to their healthy controls.
Danish: MDRD-formlen (Modification of Diet in Renal Disease) havde en eksponering på 101 % (Cmax) og 122 % (AUC0-tz) i forhold til de raske forsøgspersoner.
English: GIOTRIF 50 mg film-coated tablets One film-coated tablet contains 50 mg afatinib (as dimaleate).
Danish: Giotrif 50 mg filmovertrukne tabletter Én filmovertrukket tablet indeholder 50 mg afatinib (som dimaleat).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 30 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER FOLIEPOSE til 30 mg
English: GIOTRIF 40 mg film-coated tablets One film-coated tablet contains 40 mg afatinib (as dimaleate).
Danish: Giotrif 40 mg filmovertrukne tabletter En filmovertrukket tablet indeholder 40 mg afatinib (som dimaleat).
English: General disorders and administration site conditions Pyrexia
Danish: Almene symptomer og reaktioner på administrationsstedet Feber
English: INFORMATION IN BRAILLE GIOTRIF 20 mg
Danish: INFORMATION I BRAILLESKRIFT Giotrif 20 mg
English: Hypersensitivity to afatinib or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Dark blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T30” on one side and the Boehringer Ingelheim company logo on the other.
Danish: Mørkeblå, rund, bikonveks og skråt afskåret filmovertrukket tablet præget med koden “T30” på den ene side og Boehringer Ingelheims firmalogo på den anden side.
English: INFORMATION IN BRAILLE GIOTRIF 50 mg
Danish: INFORMATION I BRAILLESKRIFT Giotrif 50 mg
English: Each film-coated tablet contains 20 mg of afatinib (as dimaleate).
Danish: Hver filmovertrukket tablet indeholder 20 mg afatinib (som dimaleat).
English: GIOTRIF 30 mg film-coated tablets
Danish: Giotrif 30 mg filmovertrukne tabletter
English: INFORMATION IN BRAILLE GIOTRIF 30 mg
Danish: INFORMATION I BRAILLESKRIFT Giotrif 30 mg
English: GIOTRIF 40 mg film-coated tablets
Danish: Giotrif 40 mg filmovertrukne tabletter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 20 mg)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON (FOLDEÆSKE TIL BLISTER til 20 mg)
English: GIOTRIF 50 mg film-coated tablets EU/1/13/879/010
Danish: Giotrif 50 mg filmovertrukne tabletter EU/1/13/879/010
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 40 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER FOLIEPOSE til 40 mg
English: INFORMATION IN BRAILLE GIOTRIF 40 mg
Danish: INFORMATION I BRAILLESKRIFT Giotrif 40 mg
English: Includes group of rash preferred terms
Danish: Omfatter gruppen af MedDRA standardtermer for udslæt.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 50 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER FOLIEPOSE til 50 mg