natgillin/translations-raw huggingface dataset:
Intravenøs administration af elektrolytter og væske kan være nødvendig hos patienter, som bliver dehydrerede.
Patients who become dehydrated may require administration of intravenous electrolytes and fluids.
Hazard ratio for PFS for patienter med Del 19-mutationer og L858R-mutationer var hhv. 0,76 (95 %-CI [0,55; 1,06]; p = 0,1071) og 0,71 (95 %-CI [0,47; 1,06]; p = 0,0856) for afatinib vs. gefitinib.
The PFS hazard ratio for patients with DEL 19 mutations and L858R mutations was 0.76 (95% CI [0.55, 1.06]; p=0.1071), and 0.71 (95% CI [0.47, 1.06]; p=0.0856) respectively for afatinib vs gefitinib.
Blandt de randomiserede patienter var 62 % kvinder, gennemsnitsalderen var 63 år, 16 % havde hjernemetastaser, baseline-ECOG-performancestatus var 0 (31 %) eller 1 (69 %), 57 % var af asiatisk oprindelse, og 43 % var af ikke-asiatisk oprindelse.
Among the patients randomised, 62% were female, the median age was 63 years, 16% of patients had brain metastases, the baseline ECOG performance status was 0 (31%) or 1 (69%), 57% were Asian and 43% were non-Asian.
Tabel 9: Effektresultater for Giotrif vs. gefitinib (LUX-Lung 7) på grundlag af den primære analyse fra august 2015.
Table 9: Efficacy results of GIOTRIF vs. gefitinib (LUX-Lung 7) based on primary analysis as of August
DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Tabel 7: PFS og OS effektresultater for Giotrif vs. pemetrexed/cisplatin (LUX-Lung 3) og vs. gemcitabin/cisplatin (LUX-Lung 6) i de foruddefinerede EGFR-mutationundergrupper Del 19 og L858R (uafhængig vurdering)
Table 7: PFS and OS efficacy results of GIOTRIF vs pemetrexed/cisplatin (LUX-Lung 3) gemcitabine/cisplatin (LUX-Lung 6) in the pre-defined EGFR mutation subgroups Del 19 and L858R (Independent review)
Opslæmningen kan også gives gennem en ventrikelsonde.
The dispersion can also be administered through a gastric tube.
• Appetitløshed
• Decreased appetite
Analyse af GIOTRIFs virkning hos EGFR TKI-naive patienter med tumorer, der indeholder ikkealmindelige EGFR-mutationer (LUX-Lung 2, -3og -6) I tre kliniske studier af GIOTRIF med prospektiv tumor-genotyping (fase III-studierne LUX Lung 3 og -6, og fase II-enkeltgruppestudiet LUX-Lung 2) blev der udført en analyse af data fra i alt 75 TKI-naive patienter med fremskredne (trin IIIb-IV) lungeadenokarcinomer, der indeholdt ikkealmindelige EGFR-mutationer, der blev defineret som alle andre mutationer end Del 19- og L858R-mutationer.
In three clinical trials of GIOTRIF with prospective tumour genotyping (Phase 3 trials LUX-Lung 3 and -6, and single arm Phase 2 trial LUX-Lung 2), an analysis was conducted of data from a total of 75 TKI-naïve patients with advanced (stage IIIb-IV) lung adenocarcinomas harbouring uncommon EGFR mutations, which were defined as all mutations other than Del 19 and L858R mutations.
Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines and medicines obtained without a prescription.
• hvis du pludselig får røde øjne og ondt i øjet (eller forværring af dette), oplever, at øjnene løber mere i vand eller får uklart syn og/eller lysfølsomhed.
• if you develop acute or worsening redness and pain in the eye, increased eye watering, blurred vision and/or sensitivity to light.
Dette betyder helst 6 timer (for P-gp-hæmmere, der doseres to gange daglig) eller 12 timer (for P-gp-hæmmere, der doseres en gang daglig) fra Giotrif (se pkt.
This means preferably 6 hours (for P-gp inhibitors dosed twice daily) or 12 hours (for P-gp inhibitors dosed once daily) apart from GIOTRIF (see section 4.5).
Grad 2 (> 2,5 til 5,0 gange øvre normalgrænse (ULN)) ALAT-forhøjelser forekom hos < 8 % af patienter, og grad 3 (> 5,0 til 20,0 gange ULN) forhøjelser forekom hos < 4 % af patienterne (se pkt.
Grade 2 (> 2.5 to 5.0 times upper limit of normal (ULN)) ALT elevations occurred in < 8% of patients treated with this medicinal product.
Eksponeringen for afatinib er vist at være forøget hos patienter med moderat eller svært nedsat nyrefunktion (se pkt.
Exposure to afatinib was found to be increased in patients with moderate or severe renal impairment (see section 5.2).
Dette lægemiddel skal tages uden mad (se pkt.
This medicinal product should be administered without food (see sections 4.2 and 5.2).
In vitro data viser, at afatinib er en moderat P-gp-hæmmer.
Based on in vitro data, afatinib is a moderate inhibitor of P-gp.
Forhøjet alanin-aminotransferase Hud og subkutane væv
Alanine aminotransferase increased Skin and subcutaneous tissue disorders Rash
Eksponeringen for afatinib hos patienter med nedsat nyrefunktion blev sammenlignet med eksponeringen hos raske forsøgspersoner efter administration af en enkeltdosis på 40 mg Giotrif.
Exposure to afatinib in subjects with renal impairment was compared to healthy volunteers following a single dose of 40 mg GIOTRIF.
Forhøjet alanin-aminotransferase Forhøjet aspartat-aminotransferase
Aspartate aminotransferase increased
Hos patienter med svær diarré kan midlertidig seponering og dosisreduktion eller permanent seponering af Giotrif være nødvendig (se pkt.
Patients with severe diarrhoea may require interruption and dose reduction or discontinuation of therapy with GIOTRIF (see section 4.2).
Patienterne blev screenet for tilstedeværelse af 29 forskellige EGFR-mutationer ved hjælp af en polymerasekædereaktions (PCR) -baseret metode (TheraScreen®: EGFR29 Mutation Kit, Qiagen Manchester Ltd).
Patients were screened for the presence of 29 different EGFR mutations using a polymerase chain reaction (PCR)-based method (TheraScreen
Den samlede hazard ratio for overlevelse var 0,68 (95 % CI: 0,55-0,85) for patienter under 65 år og 0,95 (95 % CI: 0,76-1,19) for patienter på 65 år og derover.
The overall survival hazard ratio in patients < 65 years of age was 0.68 (95% CI 0.55, 0.85) and in patients 65 years of age and older it was 0.95 (95% CI 0.76, 1.19).
4.4) samt stomatitis og paronykie (se også Tabel 3, 4 og 5).
The most frequent ADRs were diarrhoea and skin related adverse events (see section 4.4) as well as stomatitis and paronychia (see also Table 3, 4 and 5).
Virkningen af og sikkerheden ved Giotrif som andenlinjebehandling hos patienter med fremskreden planocellulær NSCLC blev undersøgt i et randomiseret, åbent, globalt fase 3-studie (LUX-Lung 8).
The efficacy and safety of GIOTRIF as second-line treatment for patients with advanced NSCLC of squamous histology was investigated in a randomized open-label global Phase III trial LUX-Lung 8.
28 x 1 filmovertrukne tabletter
28 x 1 film-coated tablets
De væsentligste cirkulerende afatinibmetabolitter var kovalente addukter med proteiner.
Covalent adducts to proteins were the major circulating metabolites of afatinib.
Amning Du må ikke amme, mens du tager Giotrif, da det ikke kan udelukkes, at der er en risiko for barnet.
Breast-feeding Do not breast-feed while taking this medicine as a risk to the breast-fed child cannot be excluded.
• hvis du får et udslæt på huden.
• if you develop skin rash.
Mødre skal frarådes at amme, mens de får Giotrif.
Mothers should be advised against breast-feeding while receiving this medicinal product.
Afatinibs farmakokinetik er ikke undersøgt hos personer med svær (Child-Pugh C) leverdysfunktion (se pkt.
The pharmacokinetics of afatinib have not been studied in subjects with severe (Child Pugh C) hepatic dysfunction (see section 4.4).
Du skal undgå at blive gravid, mens du tager Giotrif.
You should avoid becoming pregnant while taking this medicine.
Responsvarighed Måneder (median)
Duration of response Months (median)
Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 patienter):
Rare side effects (may affect up to 1 in 1,000 people):
Andenlinjebehandling med Giotrif medførte signifikant forbedret PFS og OS for patienter med planocellulær NSCLC sammenlignet med erlotinib.
Second-line GIOTRIF significantly improved PFS and OS of patients with squamous NSCLC compared to erlotinib.
Omfatter akne, pustuløs akne, akneiform dermatitis.
Includes Acne, Acne pustular, Dermatitis acneiform
Ved de første tegn på diarré skal du drikke rigeligt med væske og kontakte lægen med det samme.
At the first signs of diarrhoea drink plenty of fluids.
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).
Eye irritation or inflammation may occur (conjunctivitis/keratoconjunctivitis occurs commonly and keratitis uncommonly).
Giotrif forbedrede signifikant PFS og OS hos EGFR-mutationspositive patienter sammenlignet med gefitinib.
GIOTRIF significantly improved PFS and ORR in EGFR mutation positive patients compared to gefitinib.
Lactosemonohydrat Mikrokrystallinsk cellulose (E460) Kolloid vandfri silica (E551) Crospovidon (type A) Magnesiumstearat (E470b)
Lactose monohydrate Cellulose, microcrystalline (E460) Silica, colloidal anhydrous (E551) Crospovidone (type A) Magnesium stearate (E470b)
ErbB-familiemedlemmerne EGFR (ErbB1), HER2 (ErbB2), ErbB3 og ErbB4.
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.
- 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.
- 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.
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.
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.
Hazard ratio/ Oddsratio (95 %-CI)
Hazard Ratio/ Odds Ratio (95%CI)
Tabel 3: Meget almindelige bivirkninger i LUX-Lung 3-forsøget
Table 3: Very common ADRs in trial LUX-Lung 3
Tabel 11: Resultater for Giotrif vs. erlotinib for symptomer i LUX-Lung 8-studiet (EORTC QLQ-C30 & QLQ-LC13)
Table 11: Symptom outcomes for GIOTRIF vs. erlotinib in trial LUX-Lung 8 (EORTC QLQ-C30 & QLQ-LC13)
Anbefalet dosering
Recommended dosing
Giotrif er ikke undersøgt hos patienter med eGFT < 15 ml/min/1,73 m2 eller patienter i dialyse.
GIOTRIF has not been studied in patients with eGFR <15 mL/min/1.73m² or on dialysis.
Giotrif hos patienter med planocellulær NSCLC
GIOTRIF in patients with NSCLC of squamous histology
Omfatter kløe, generaliseret kløe.
Includes Pruritus, Pruritus generalised
Akneiform dermatitis Tør hud
Dermatitis acneiform Pruritus Dry skin
Lægen kan ændre din dosis (sætte den op eller ned).
Your doctor may adjust (increase or decrease) your dose depending on how well you tolerate this medicine.
Tabel 6: Effektresultater for Giotrif vs.pemetrexed/cisplatin (LUX-Lung 3) og vs. gemcitabin/cisplatin (LUX-Lung 6) (uafhængig vurdering)
Table 6: Efficacy results of GIOTRIF vs. pemetrexed/cisplatin (LUX-Lung 3) gemcitabine/cisplatin (LUX-Lung 6) (Independent review)
Dette lægemiddel indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
Patients with rare hereditary conditions of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Generelt var typen af bivirkninger relateret til afatinibs virkningsmekanisme i form af hæmning af EGFR.
The types of adverse reactions (ADRs) were generally associated with the EGFR inhibitory mode of action of afatinib.
Oddsratio (OR) (95 % CI) p-værdi
Odds Ratio (OR) (95%CI) p-value
Hvornår skal du tage Giotrif
When to take GIOTRIF
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).