natgillin/translations-raw huggingface dataset:
Tabel 8: Resultater for symptomer for Giotrif vs. kemoterapi i forsøgene LUX-Lung 3 og LUX-Lung 6 (EORTC QLQ-C30 og QLQ-LC13) 
Table 8: Symptom outcomes for GIOTRIF vs. chemotherapy in trials LUX-Lung 3 and LUX-Lung 6 (EORTC QLQ-C30 & QLQ-LC13)
Progressionsfri overlevelse Måneder (median) Hazard ratio (HR) (95 % CI) p-værdi 
Progression-free survival Months (median) Hazard Ratio (HR) (95%CI) p-value
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. 
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.
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). 
® 40 mg orally once daily (N=160) or gefitinib 250 mg orally once daily (N=159).
- Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose (E460), kolloid vandfri silica (E551), crospovidon type A, magnesiumstearat (E470b), hypromellose (E464), macrogol 
- The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), colloidal anhydrous silica (E551), crospovidone type A, magnesium stearate (E470b), hypromellose (E464), macrogol 400,
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. 
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.
4.2), yderligere terapeutisk intervention og henvisning til en specialist med erfaring i behandling af disse dermatologiske bivirkninger. 
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.
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. 
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.
®: EGFR29 Mutation Kit, (Qiagen 
®: EGFR29 Mutation Kit (Qiagen Manchester Ltd).
Grad 1 eller grad 2 
Grade 1 or Grade 2
Nedsat nyrefunktion/ nyreinsufficiens 
Renal impairment/ Renal failure
Gemcitabin/ cisplatin (N=122) 
Gemcitabine/ Cisplatin (N=122)
I live efter 18 mdr. 
Alive at 12 months Alive at 18 months
Stevens-Johnsons syndrom 
Stevens-Johnson syndrome Toxic epidermal necrolysis
Det synes ikke at være nødvendigt at justere startdosis til patienter med let eller moderat nedsat leverfunktion (se pkt. 
No starting dose adjustments appear necessary in patients with mild or moderate hepatic impairment (see section 4.2).
Giotrif er ikke undersøgt hos patienter med svært (Child-Pugh C) nedsat leverfunktion. 
This medicinal product has not been studied in patients with severe (Child Pugh C) hepatic impairment.
Mave-tarm-kanalen Diarré Stomatitis 
Gastrointestinal disorders Diarrhoea Stomatitis
Samlet overlevelse (OS) Måneder (median) Hazard ratio (HR) (95 % CI) p-værdi 
Overall Survival (OS) Months (median) Hazard Ratio (HR) (95%CI) p-value
• Næseblod 
• Bleeding from the nose
Samlet overlevelse (OS) Måneder (median) Hazard ratio (HR) (95 % CI) p-værdi p-værdi for PFS/OS baseret på stratificeret log-rank test 
Hazard Ratio (HR) (95%CI) p-value p-value for PFS/OS based on stratified log-rank test
Behandling med Giotrif frarådes hos patienter med eGFR < 15 ml/min/1,73 m2 og patienter i dialyse. 
GIOTRIF treatment in patients with eGFR <15 mL/min/1.73m² or on dialysis is not recommended.
Der er rapporteret om udslæt/akne hos patienter behandlet med dette lægemiddel (se pkt. 
Rash/acne has been reported in patients treated with this medicinal product (see section 4.8).
Luftveje, thorax og mediastinum Rinoré 
Respiratory, thoracic and mediastinal disorders Rhinorrhoea
Hvert blisterkort indeholder 7 x 1 filmovertrukne tabletter og er pakket i en lamineret foliepose sammen med en pose tørremiddel. 
Each blister is packed together with a desiccant sachet in a laminated aluminium pouch and contains 7 x 1 film-coated tablets.
Under behandlingen er der rapporteret om øjenbivirkninger (conjunctivitis, tørre øjne, keratitis) hos nogle patienter (se pkt. 
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.
Sådan skal du tage Giotrif 
How to take GIOTRIF
Samtidig behandling med kraftige P-gp-induktorer kan reducere eksponeringen for afatinib (se pkt. 
P-glycoprotein (P-gp) interactions Concomitant treatment with strong inducers of P-gp may decrease exposure to afatinib (see section 4.5).
• Det er vigtigt, at du tager Giotrif uden mad 
• It is important to take this medicine without food
Omfatter akneiform dermatitis, akne. 
Includes Dermatitis acneiform, Acne
Omfatter stomatitis, aftøs stomatitis, slimhindeinflammation, ulceration i munden, erosion i mundslimhinden Omfatter gruppen af MedDRA-standardtermer for udslæt. 
Includes Stomatitis, Aphthous stomatitis, Mucosal inflammation, Mouth ulceration, Mucosal erosion Includes group of rash preferred terms
Paronykie 
Paronychia
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. 
However, this medicinal product has not been studied in patients with abnormal left ventricular ejection fraction (LVEF) or those with significant cardiac history.
Når du tager dette lægemiddel, skal du kontakte lægen med det samme: 
Inform your doctor immediately while taking this medicine:
I LUX-Lung 8 sås ingen grad 3-stigninger i ALAT/ASAT hos patienter med unormale leverfunktionsværdier ved baseline (se pkt. 
There were no Grade 3 ALT/AST elevations in patients with abnormal baseline liver tests in LUX-Lung 8 (see section 4.8).
Omfatter rinoré, nasal inflammation. 
Includes Hypokalaemia, Blood potassium decreased Includes Rhinorrhoea, Nasal inflammation
Gemcitabin/ cisplatin (N=62) 
Gemcitabine/ Cisplatin (N=62)
Gemcitabin/ cisplatin (N=46) 
Gemcitabine/ Cisplatin (N=46)
Patienter med svært nedsat nyrefunktion (n = 8; eGFR 15-29 ml/min/1,73 m² iht. 
Subjects with severe renal impairment (n=8; eGFR 15-29 mL/min/1.73m², according to the
Giotrif skal seponeres, indtil disse symptomer er blevet undersøgt. 
Treatment with this medicinal product should be interrupted pending investigation of these symptoms.
Solbeskyttelse med dækkende beklædning og solcreme anbefales. 
Rash may occur or worsen in areas exposed to sun. Sun protection with protective clothing and sunscreen is recommended.
Palmoplantar erytrodysæstesi-syndrom Neglesygdomme 
Palmar-plantar erythrodysaesthesia syndrome
Omfatter stomatitis, aftøs stomatitis, slimhindeinflammation, ulceration i munden, erosion i mundslimhinden, slimhindeerosion, slimhindeulceration. 
Includes Paronychia, Nail infection, Nail bed infection Includes Stomatitis, Aphthous stomatitis, Mucosal inflammation, Mouth ulceration, Oral mucosa erosion, Mucosal erosion, Mucosal ulceration
Hazard ratio/ Oddsratio (95 %-CI) p-værdi 
Hazard Ratio/ Odds Ratio (95%CI) p-value
Omfatter paronykie, negleinfektion, neglelejeinfektion. 
Includes Paronychia, Nail infection, Nail bed infection Includes Cystitis, Urinary tract infection
• Mavesmerter, problemer med fordøjelsen, halsbrand 
• Stomach pain, indigestion, heartburn
Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ. 
This leaflet was last approved in {MM/YYYY} Other sources of information
- Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her. 
Contact your doctor as soon as possible if you suffer from any of the serious side effects listed below.
Hjælpestof, som behandleren skal være opmærksom på Én filmovertrukket tablet indeholder 294 mg lactose (som monohydrat). 
One film-coated tablet contains 294 mg lactose (as monohydrate).
En populationsfarmakokinetisk analyse, der omfattede asiatiske, hvide og sorte patienter, viste, at etnisk oprindelse ikke havde nogen indvirkning på afatinibs farmakokinetik. 
Race had no effect on the pharmacokinetics of afatinib based on a population pharmacokinetic analysis, including patients of Asian, White, and Black racial groups.
Justering af startdosis er ikke nødvendig hos patienter med let nedsat nyrefunktion (eGFR 60-89 ml/min/1,73 m2), moderat nedsat nyrefunktion (eGFR 
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.
Omfatter neglesygdomme, onykolyse, negletoksicitet, onykoklase, nedgroede negle, neglepitting, onykomadese, misfarvede negle, negledystrofi, rillede negle og onykogrypose. 
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
Det skal du vide, før du begynder at tage Giotrif Sådan skal du tage Giotrif Bivirkninger 
What you need to know before you take GIOTRIF
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). 
Body weight Plasma exposure (AUCτ,ss) was increased by 26% for a 42 kg patient (2.5
Giotrif 20 mg filmovertrukne tabletter er hvide til gullige og runde. 
What GIOTRIF looks like and contents of the pack GIOTRIF 20 mg film-coated tablets are white to yellowish and round shaped.
Giotrif 50 mg filmovertrukne tabletter er mørkeblå og ovale. 
What GIOTRIF looks like and contents of the pack GIOTRIF 50 mg film-coated tablets are dark blue and oval shaped.
Hjælpestof, som behandleren skal være opmærksom på En filmovertrukket tablet indeholder 176 mg lactose (som monohydrat). 
One film-coated tablet contains 176 mg lactose (as monohydrate).
Hud og subkutane væv Udslæt 
Skin and subcutaneous tissue disorders Rash
Hjælpestof, som behandleren skal være opmærksom på En filmovertrukket tablet indeholder 118 mg lactose (som monohydrat). 
One film-coated tablet contains 118 mg lactose (as monohydrate).
• 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. 
• Inflammation of the lungs (uncommon, may affect up to 1 in 100 people) called “interstitial lung disease”.
Hjælpestof, som behandleren skal være opmærksom på En filmovertrukket tablet indeholder 235 mg lactose (som monohydrat). 
One film-coated tablet contains 235 mg lactose (as monohydrate).
MedDRA-standardterm 
Progression-free survival
Giotrif 20 mg filmovertrukne tabletter En filmovertrukket tablet indeholder 20 mg afatinib (som dimaleat). 
GIOTRIF 20 mg film-coated tablets One film-coated tablet contains 20 mg afatinib (as dimaleate).
Giotrif 30 mg filmovertrukne tabletter er mørkeblå og runde. 
What GIOTRIF looks like and contents of the pack GIOTRIF 30 mg film-coated tablets are dark blue and round shaped.
Mave-tarm-kanalen Diarré 
Gastrointestinal disorders Diarrhoea
I tilfælde af diarré skal der straks iværksættes behandling med midler mod diarré (f.eks. loperamid). 
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.
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER FOLIEPOSE til 20 mg 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 20 mg
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. 
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.
• Sår og irritation i munden 
• Mouth sores and inflammation
Mørkeblå, oval, bikonveks filmovertrukket tablet præget med koden “T50” på den ene side og Boehringer Ingelheims firmalogo på den anden side. 
Dark blue, oval, biconvex film-coated tablet debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PERFORERET BLISTER til 20 mg 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 20 mg
Giotrif 40 mg filmovertrukne tabletter er lyseblå og runde. 
What GIOTRIF looks like and contents of the pack GIOTRIF 40 mg film-coated tablets are light blue and round shaped.
Giotrif 20 mg filmovertrukne tabletter 
GIOTRIF 20 mg film-coated tablets
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. 
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.
Giotrif 30 mg filmovertrukne tabletter En filmovertrukket tablet indeholder 30 mg afatinib (som dimaleat). 
GIOTRIF 30 mg film-coated tablets One film-coated tablet contains 30 mg afatinib (as dimaleate).
MDRD-formlen (Modification of Diet in Renal Disease) havde en eksponering på 101 % (Cmax) og 122 % (AUC0-tz) i forhold til de raske forsøgspersoner. 
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.
Giotrif 50 mg filmovertrukne tabletter Én filmovertrukket tablet indeholder 50 mg afatinib (som dimaleat). 
GIOTRIF 50 mg film-coated tablets One film-coated tablet contains 50 mg afatinib (as dimaleate).
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER FOLIEPOSE til 30 mg 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 30 mg
Giotrif 40 mg filmovertrukne tabletter En filmovertrukket tablet indeholder 40 mg afatinib (som dimaleat). 
GIOTRIF 40 mg film-coated tablets One film-coated tablet contains 40 mg afatinib (as dimaleate).
Almene symptomer og reaktioner på administrationsstedet Feber 
General disorders and administration site conditions Pyrexia
INFORMATION I BRAILLESKRIFT Giotrif 20 mg 
INFORMATION IN BRAILLE GIOTRIF 20 mg
Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt. 
Hypersensitivity to afatinib or to any of the excipients listed in section 6.1.
Mørkeblå, rund, bikonveks og skråt afskåret filmovertrukket tablet præget med koden “T30” på den ene side og Boehringer Ingelheims firmalogo på den anden side. 
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.
INFORMATION I BRAILLESKRIFT Giotrif 50 mg 
INFORMATION IN BRAILLE GIOTRIF 50 mg
Hver filmovertrukket tablet indeholder 20 mg afatinib (som dimaleat). 
Each film-coated tablet contains 20 mg of afatinib (as dimaleate).
Giotrif 30 mg filmovertrukne tabletter 
GIOTRIF 30 mg film-coated tablets
INFORMATION I BRAILLESKRIFT Giotrif 30 mg 
INFORMATION IN BRAILLE GIOTRIF 30 mg
Giotrif 40 mg filmovertrukne tabletter 
GIOTRIF 40 mg film-coated tablets
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON (FOLDEÆSKE TIL BLISTER til 20 mg) 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 20 mg)
Giotrif 50 mg filmovertrukne tabletter EU/1/13/879/010 
GIOTRIF 50 mg film-coated tablets EU/1/13/879/010
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER FOLIEPOSE til 40 mg 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 40 mg
INFORMATION I BRAILLESKRIFT Giotrif 40 mg 
INFORMATION IN BRAILLE GIOTRIF 40 mg
Omfatter gruppen af MedDRA standardtermer for udslæt. 
Includes group of rash preferred terms
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER FOLIEPOSE til 50 mg 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 50 mg
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PERFORERET BLISTER til 30 mg 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 30 mg
Giotrif 20 mg filmovertrukne tabletter afatinib 
GIOTRIF 20 mg film-coated tablets afatinib
LÆGEMIDLETS NAVN Giotrif 20 mg tabletter afatinib 
NAME OF THE MEDICINAL PRODUCT GIOTRIF 20 mg tablets afatinib
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PERFORERET BLISTER til 50 mg 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 50 mg
værdier vist for Giotrif vs. kemoterapi, p-værdi baseret på logistisk regression b p-værdier for tiden indtil forværring baseret på stratificeret log-rank test 
6.9 vs. 3.4 HR 0.70; p=0.0220 values presented for GIOTRIF vs. chemotherapy, p-value based on logistic regression b p-value for time to deterioration based on stratified log-rank test
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PERFORERET BLISTER til 40 mg 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 40 mg
Lyseblå, rund, bikonveks og skråt afskåret filmovertrukket tablet præget med koden “T40” på den ene side og Boehringer Ingelheims firmalogo på den anden side. 
Light blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T40” on one side and the Boehringer Ingelheim company logo on the other.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 20 mg afatinib (som dimaleat). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg afatinib (as dimaleate).
Hver filmovertrukket tablet indeholder 50 mg afatinib (som dimaleat). 
Each film-coated tablet contains 50 mg of afatinib (as dimaleate).
Giotrif 50 mg filmovertrukne tabletter 
GIOTRIF 50 mg film-coated tablets
Hver filmovertrukket tablet indeholder 40 mg afatinib (som dimaleat). 
Each film-coated tablet contains 40 mg of afatinib (as dimaleate).
Hver filmovertrukket tablet indeholder 30 mg afatinib (som dimaleat). 
Each film-coated tablet contains 30 mg of afatinib (as dimaleate).
LÆGEMIDLETS NAVN Giotrif 50 mg tabletter afatinib 
NAME OF THE MEDICINAL PRODUCT GIOTRIF 50 mg tablets afatinib
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/879/010 
MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/010
Giotrif 30 mg filmovertrukne tabletter EU/1/13/879/004 
GIOTRIF 30 mg film-coated tablets EU/1/13/879/004
Giotrif 20 mg filmovertrukne tabletter EU/1/13/879/001 
GIOTRIF 20 mg film-coated tablets EU/1/13/879/001
Giotrif 30 mg filmovertrukne tabletter afatinib 
GIOTRIF 30 mg film-coated tablets afatinib
Giotrif 40 mg filmovertrukne tabletter afatinib 
GIOTRIF 40 mg film-coated tablets afatinib
LÆGEMIDLETS NAVN Giotrif 40 mg tabletter afatinib 
NAME OF THE MEDICINAL PRODUCT GIOTRIF 40 mg tablets afatinib
LÆGEMIDLETS NAVN Giotrif 30 mg tabletter afatinib 
NAME OF THE MEDICINAL PRODUCT GIOTRIF 30 mg tablets afatinib
De er præget med koden “T20” på den ene side og Boehringer Ingelheim firmalogo på den anden side. 
They are debossed with the code “T20” on one side and the Boehringer Ingelheim company logo on the other.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON (FOLDEÆSKE TIL BLISTER til 30 mg) 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 30 mg)
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON (FOLDEÆSKE TIL BLISTER til 40 mg) 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 40 mg)
LÆGEMIDLETS NAVN Giotrif 20 mg filmovertrukne tabletter afatinib 
NAME OF THE MEDICINAL PRODUCT GIOTRIF 20 mg film-coated tablets afatinib
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 30 mg afatinib (som dimaleat). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg afatinib (as dimaleate).
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON (FOLDEÆSKE TIL BLISTER til 50 mg) 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 50 mg)
Giotrif 40 mg filmovertrukne tabletter EU/1/13/879/007 
GIOTRIF 40 mg film-coated tablets EU/1/13/879/007
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 40 mg afatinib (som dimaleat). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 40 mg afatinib (as dimaleate).
De er præget med koden “T30” på den ene side og Boehringer Ingelheim firmalogo på den anden side. 
They are debossed with the code “T30” on one side and the Boehringer Ingelheim company logo on the other.
Hvis du pludselig får symptomer fra øjnene, som f.eks. smerter, røde eller tørre øjne, eller hvis sådanne symptomer bliver værre, skal du fortælle det til lægen. 
Tell your doctor if you have sudden or worsening of eye symptoms such as pain or redness or dry eye.
Giotrif 50 mg filmovertrukne tabletter afatinib 
GIOTRIF 50 mg film-coated tablets afatinib
De er præget med koden “T50” på den ene side og Boehringer Ingelheim firmalogo på den anden side. 
They are debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other.
LÆGEMIDLETS NAVN Giotrif 40 mg filmovertrukne tabletter afatinib 
NAME OF THE MEDICINAL PRODUCT GIOTRIF 40 mg film-coated tablets afatinib
Dosisøgning 
Epistaxis
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Giotrif 20 mg filmovertrukne tabletter afatinib 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 20 mg film-coated tablets afatinib
LÆGEMIDLETS NAVN Giotrif 30 mg filmovertrukne tabletter afatinib 
NAME OF THE MEDICINAL PRODUCT GIOTRIF 30 mg film-coated tablets afatinib
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 50 mg afatinib (som dimaleat). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 50 mg afatinib (as dimaleate).
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Giotrif 30 mg filmovertrukne tabletter afatinib 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 30 mg film-coated tablets afatinib
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/879/004 
MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/004
LÆGEMIDLETS NAVN Giotrif 50 mg filmovertrukne tabletter afatinib 
NAME OF THE MEDICINAL PRODUCT GIOTRIF 50 mg film-coated tablets afatinib
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/879/001 
MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/001
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Giotrif 40 mg filmovertrukne tabletter afatinib 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 40 mg film-coated tablets afatinib
Næseblod Rinoré 
• Runny nose