natgillin/translations-raw huggingface dataset:
Dehydrering, Vægttab 
Dehydration, Weight decreased
Behandling med brivudin kan initieres 24 timer efter sidste dosis af capecitabin (se pkt. 
Treatment with brivudine can be started 24 hours after the last dose of capecitabine (see section 4.3 and 4.5).
Et studie om kombination af capecitabin og folinsyre tyder på, at folinsyre ikke har væsentlig effekt på farmakokinetikken af capecitabin og dets metabolitter. 
Folinic acid/folic acid: a combination study with capecitabine and folinic acid indicated that folinic acid has no major effect on the pharmacokinetics of capecitabine and its metabolites.
Ved kombinationsbehandling skal den anbefalede initialdosis af capecitabin reduceres til 8001.000 mg/m2, når det administreres to gange daglig i 14 dage efterfulgt af en pause på 7 dage eller til 625 mg/m2 to gange daglig, når det gives kontinuerligt (se pkt. 
In combination treatment, the recommended starting dose of capecitabine should be reduced to 800 - 1000 mg/m2 when administered twice daily for 14 days followed by a 7-day rest period, or to 625 mg/m2 twice daily when administered continuously (see section 5.1).
Data fra et randomiseret, kontrolleret fase II-multicenterstudie (AIO KRK 0604) støtter anvendelsen af en initial capecitabin-dosis på 800 mg/m2 i 2 uger hver 3. uge i kombination med irinotecan og bevacizumab som 1. linjebehandling af patienter med metastatisk kolorektalkræft. 
Data from a multicentre, randomised, controlled phase II study (AIO KRK 0604) supports the use of capecitabine at a starting dose of 800 mg/m2 for 2 weeks every 3 weeks in combination with irinotecan and bevacizumab for the first-line treatment of patients with metastatic colorectal cancer.
4.2, 4.4 og 5.2) 
Renal impairment (see section 4.2, 4.4, and 5.2):
En metaanalyse af 14 kliniske studier med data fra mere end 4.700 patienter, som er blevet behandlet med capecitabin-monoterapi eller capecitabin i kombination med forskellige kemoterapiregimer indenfor flere indikationer (kolonkræft, kolorektalkræft, ventrikelkræft og brystkræft) viste, at patienter behandlet med capecitabin, som udviklede hånd- og fodsyndrom, havde en længere samlet overlevelse sammenlignet med patienter, som ikke udviklede hånd- og fodsyndrom: gennemsnitlige samlede overlevelse var 1.100 dage (95 % konfidensinterval 1.007; 1.200) versus 691 dage (95 % konfidensinterval 638; 754). 
A meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications (colon, colorectal, gastric and breast cancer) showed that patients on capecitabine who developed hand-foot syndrome (HFS) had a longer overall survival compared to patients who did not develop HFS: median overall survival 1100 days (95% CI 1007;1200) vs 691 days (95% CI 638;754) with a hazard ratio of 0.61 (95% CI 0.56; 0.66).
Tabel 1 Standard og reducerede dosisberegninger ud fra legemsoverfladeareal for en initialdosis af capecitabin på 1.250 mg/m 
Table 1 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1250 mg/m
Almenesymptomer og reaktioner på administrationsstedet 
General disorders and administration site conditions
Konfusion, Panikanfald, Nedtrykthed, Nedsat libido 
Confusional state, Panic attack, Depressed mood, Libido decreased
Data fra et randomiseret fase III-multicenterstudie, der sammenlignede capecitabin med 5-FU og i kombination med enten oxaliplatin eller cisplatin til patienter med fremskreden ventrikelkræft, støtter anvendelse af capecitabin til 1. linjebehandling af fremskreden ventrikelkræft (REAL-2). 
Data from a randomised multicentre, phase III study comparing capecitabine to 5-FU and oxaliplatin to cisplatin in patients with advanced gastric cancer supports the use of capecitabine for the first-line treatment of advanced gastric cancer (REAL-2).
Hos patienter, som samtidig får behandling med capecitabin og orale antikoagulantia af coumarintypen, skal antikoagulansresponset (INR eller protrombintiden) monitoreres tæt, og antikoagulansdosis justeres, om nødvendigt (se pkt. 
Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored closely and the anticoagulant dose adjusted accordingly (see section 4.5).
Kolonkræft, kolorektalkræft og brystkræft 
Colon, colorectal and breast cancer
uger efterfulgt af en uges pause og behandling med docetaxel 75 mg/m2 som 1 times intravøs infusion hver 3. uge). 
weeks followed by 1-week rest period and docetaxel 75 mg/m2 as a 1 hour intravenous infusion every
En metaanalyse af 14 kliniske studier med data fra mere end 4.700 patienter, som er blevet behandlet med capecitabin-monoterapi eller capecitabin i kombination med forskellige kemoterapiregimer indenfor flere indikationer (kolonkræft, kolorektalkræft, ventrikelkræft og brystkræft) viste, at håndog fodsyndrom (alle grader) forekom hos 2.066 (43 %) patienter gennemsnitligt 239 [95 % konfidensinterval 201, 288] dage efter behandlingsstart med capecitabin. 
A meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications (colon, colorectal, gastric and breast cancer) showed that HFS (all grades) occurred in 2066 (43%) patients after a median time of 239 [95% CI 201, 288] days after starting treatment with capecitabine.
Fluorouracil 400 mg/m intravenøs bolus, efterfulgt af 
5-Fluorouracil 400 mg/m intravenous bolus, followed by 600 mg/ 2 intravenous 22 hr
Dosisniveau på 1.000 mg/m 2 (to gange dagligt) 
Dose level 1000 mg/m 2 (twice daily)
Øvre gastrointestinal blødning, Sår i munden, Gastritis, Abdominal distension, Gastroøsofageal refluxsygdom, Smerter i munden, Dysfagi, Rektal blødning, Nedre abdominalsmerter, Oral dysæstesi, Oral paræstesi, Oral hypoæstesi, Abdominal ubehag 
Constipation, Dyspepsia Upper gastrointestinal haemorrhage, Mouth ulceration, Gastritis, Abdominal distension, Gastroesophageal reflux disease, Oral pain, Dysphagia, Rectal haemorrhage, Abdominal pain lower, Oral dysaesthesia, Paraesthesia oral, Hypoaesthesia oral, Abdominal discomfort
(95% KI) 
95% CI
Sammenligningen viste, at XELOX plus bevacizumab svarede til FOLFOX-4 plus bevacizumab med hensyn til progressionsfri overlevelse (hazard ratio 1,01; 97,5 % konfidensinterval 0,84 - 1,22). 
In this treatment subgroup comparison, XELOX plus bevacizumab was similar compared to FOLFOX-4 plus bevacizumab in terms of progression-free survival (hazard ratio 1.01; 97.5% CI 0.84 - 1.22).
Hikke, Faryngolaryngeal smerte, Dysfoni 
Hiccups, Pharyngolaryngeal pain, Dysphonia
Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin, har brugt anden medicin eller planlægger at bruge anden medicin. 
Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Øget tåresekretion Synsforstyrrelser, Tørre øjne, Øjensmerter, Synsnedsættelse, Sløret syn 
Lacrimation increased Visual disorders, Dry eye, Eye pain, Visual impairment, Vision blurred
I den primære analyse af sygdomsfri overlevelse hos ITT-populationen, viste XELOX sig at være signifikant superior i forhold til 5-FU/LV (hazard ratio = 0,80, 95 % konfidensinterval = [0,69; 0,93], p = 0,0045). 
In the primary analysis for DFS in the ITT population, XELOX was shown to be significantly superior to 5-FU/LV (HR=0.80, 95% CI=[0.69; 0.93]; p=0.0045).
Dosisændring på grund af toksicitet, når capecitabin anvendes kontinuerligt i kombination med andre lægemidler, skal foretages efter tabel 3 ovenfor for capecitabin og efter det pågældende produktresumé for det andet lægemiddel/de andre lægemidler. 
Dose modifications for toxicity when capecitabine is used continuously in combination with other medicinal products should be made according to table 3 above for capecitabine and according to the appropriate summary of product characteristics for the other medicinal product(s).
60 filmovertrukne tabletter 
60 film-coated tablets
Feber, 
+Fever,
Capecitabin var mindst ækvivalent med 5-FU/LV intravenøs mht. sygdomsfri overlevelse i protokolpopulationen (hazard ratio 0,92; 95 % konfidensinterval 0,80-1,06). 
Capecitabine was at least equivalent to intravenous 5-FU/LV in disease-free survival in per protocol population (hazard ratio 0.92; 95% CI 0.80-1.06).
Analysen for det sekundære endepunkt, relapsfri overlevelse, støtter dissse resultater med en hazard ratio på 0,78 (95 % konfidensinterval = [0,67; 0,92], p = 0,0024) for XELOX versus 5-FU/LV. 
The analysis for the secondary endpoint of RFS supports these results with a HR of 0.78 (95% CI=[0.67; 0.92]; p=0.0024) for XELOX vs. 5-FU/LV.
Interferon-alfa Capecitabins MTD var 2.000 mg/m 2/dag, når det kombineredes med interferon alfa-2a (3 MIE/m 2/dag) 
Interferon alpha: the MTD of capecitabine was 2000 mg/m2 per day when combined with interferon alpha-2a (3 MIU/m2 per day) compared to 3000 mg/m2 per day when capecitabine was used alone.
ved 2. forekomst ved 3. forekomst ved 4. forekomst 
-2nd appearance -3rd appearance -4th appearance
Hæmaturi, Proteinuri, Nedsat renal kreatininclearance, Dysuri 
Haematuria, Proteinuria, Creatinine renal clearance decreased, Dysuria
Efter behandling med capecitabin er der set hudtoksicitet, karakteriseret ved degenerative/regressive forandringer. 
Skin toxicity, characterised by degenerative/regressive changes, was observed with capecitabine.
I dette studie randomiseredes 255 patienter til behandling med capecitabin (1.250 mg/m2 to gange dagligt i 2 
In this trial, 255 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Ecansya 150 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 150 mg capecitabin. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Ecansya 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine.
Resultaterne fra en metaanalyse af 14 kliniske studier med data fra mere end 4.700 patienter, som er blevet behandlet med capecitabin, viste at i alle studier kombineret, var kvindeligt køn statistisk signifikant associeret med en øget risiko for udviklingen af hånd- og fodsyndrom og diarré og med en faldende risiko for at udvikle neutropeni. 
The results of a meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine showed that in all studies combined, female gender was statistically significantly associated with an increased risk of developing HFS and diarrhoea and with a decreased risk of developing neutropenia.
Antikoagulantia af coumarintypen 
Coumarin-derivative anticoagulation.
En metaanalyse af 14 kliniske studier med data fra mere end 4.700 patienter, som er blevet behandlet med capecitabin, viste i alle studier kombineret at følgende kovarianter var statistisk signifikant associeret med en øget risiko for udviklingen af diarré: stigende capecitabin-startdosis (gram), længere behandlingsvarighed (uger), stigende alder (ved 10-års forøgelse) samt kvindeligt køn. 
The results of a meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine showed that in all studies combined, the following covariates were statistically significantly associated with an increased risk of developing diarrhoea: increasing capecitabine starting dose (gram), increasing duration of study treatment (weeks), increasing age (by 10 year increments), and female gender.
Hydronefrose, Urininkontinens, Hæmaturi, Nokturi, Forøget blodkreatinin 
Hydronephrosis, Urinary incontinence, Haematuria, Nocturia, Blood creatinine increased
Ældre patienter ((≥ 65 år) havde, sammenlignet med yngre patienter, flere bivirkninger af grad 3 og 4, inklusiv dem, som førte til seponering, når capecitabin blev anvendt i kombination med andre lægemidler. 
When capecitabine was used in combination with other medicinal products, elderly patients (≥65 years) experienced more grade 3 and grade 4 adverse drug reactions, including those leading to discontinuation, compared to younger patients.
I den samlede randomiseringspopulation blev capecitabin vist at være bedre end 5-FU/LV mht. sygdomsfri overlevelse (hazard ratio 0,849; 95 % konfidensinterval 0,739 - 0,976; p = 0,0212) og mht. samlet overlevelse (hazard ratio 0,828; 95 % konfidensinterval 0,705 - 0,971; p = 0,0203). 
In the allrandomised population, capecitabine was shown to be superior to 5FU/LV for disease-free survival (hazard ratio 0.849; 95% CI 0.739 - 0.976; p = 0.0212), as well as for overall survival (hazard ratio 0.828; 95% CI 0.705 - 0.971; p = 0.0203).
Ecansya forårsage svimmelhed, kvalme og træthed. 
Ecansya may make you feel dizzy, nauseous or tired.
Ecansya 150 mg filmovertrukne tabletter Ecansya 300 mg filmovertrukne tabletter Ecansya 500 mg filmovertrukne tabletter capecitabin 
Ecansya 150 mg film-coated tablets Ecansya 300 mg film-coated tablets Ecansya 500 mg film-coated tablets capecitabine
5.1) til behandling af patienter med lokal fremskreden eller metastatisk brystkræft efter svigt af cytotoksisk kemoterapi. 
- in combination with docetaxel (see section 5.1) for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
1.000 mg/m2 oral 2 gange daglig 
Capecitabine 1000 mg/m 2 oral twice daily
Brivudin må derfor ikke administreres samtidig med capecitabin (se pkt. 
Therefore, brivudine must not be administered concomitantly with capecitabine (see section 4.3 and 4.4).
Grad 1 hånd- og fodsyndrom defineres som følelsesløshed, dysæstesi/paræstesi, prikken, hævelse eller erytem uden smerter af hænderne og/eller fødderne og/eller ubehag der ikke påvirker patienternes daglige aktiviteter. 
Grade 1 hand-foot syndrome is defined as numbness, dysesthesia/paresthesia, tingling, painless swelling or erythema of the hands and/or feet and/or discomfort which does not disrupt the patient's normal activities.
Derfor skal du altid kontakte lægen så snart du får en bivirkning. 
These side effects can become severe; therefore, it is important that you always contact your doctor immediately when you start to experience a side effect.
For capecitabindosis på 1.250 mg/m to gange dagligt på dagene 1 til 14 hver 3. uge blev der observeret hånd- og fodsyndrom i alle grader med en hyppighed på 53 % til 60 % i cabecitabinmonoterapistudierne (bestående af studier i adjuverende behandling af kolonkræft, behandling af metastatisk kolorektalkræft og behandling af brystkræft). 
Hand-foot syndrome (see section 4.4): For the capecitabine dose of 1250 mg/m2 twice daily on days 1 to 14 every 3 weeks, a frequency of 53% to 60% of all-grades HFS was observed in capecitabine monotherapy trials (comprising studies in adjuvant therapy in colon cancer, treatment of metastatic colorectal cancer, and treatment of breast cancer) and a frequency of 63% was observed in the capecitabine/docetaxel arm for the treatment of metastatic breast cancer.
Monoterapi med capecitabin ved metastatisk kolorektalkræft Data fra to identisk designede, randomiserede, kontrollerede, kliniske multicenterstudier i fase III (SO14695; SO14796) støtter anvendelsen af capecitabin til 1. linjebehandling af metastatisk kolorektalkræft. 
Monotherapy with capecitabine in metastatic colorectal cancer Data from two identically-designed, multicentre, randomised, controlled phase III clinical trials (SO14695; SO14796) support the use of capecitabine for first line treatment of metastatic colorectal cancer.
Der er ikke gennemført formelle lægemiddelinteraktionsstudier med capecitabin og andre CYP2C9substrater bortset fra warfarin. 
Cytochrome P-450 2C9 substrates: Other than warfarin, no formal interaction studies between capecitabine and other CYP2C9 substrates have been conducted.
Data fra et randomiseret, kontrolleret, klinisk fase III-multicenterstudie hos patienter med kolonkræft i stadium III (Dukes' stadium C) støtter anvendelsen af capecitabin i kombination med oxaliplatin (XELOX) til adjuverende behandling af patienter med kolonkræft (studie NO16968). 
Data from one multicentre, randomised, controlled phase 3 clinical trial in patients with stage III (Dukes' C) colon cancer supports the use of capecitabine in combination with oxaliplatin (XELOX) for the adjuvant treatment of patients with colon cancer (NO16968 study).
Bivirkningerne er anført i frekvensgruppering ud fra den højeste hyppighed set i en af de store kliniske studier. 
ADRs are added according to the highest incidence seen in any of the major combination trials.
Hyperhidrose, Erytematøst udslæt, Urticaria, Nattesved 
Alopecia, Nail disorder Hyperhidrosis, Rash erythematous, Urticaria, Night sweats
Vandfri lactose Croscarmellosenatrium Hypromellose (E-5) Mikrokrystallinsk cellulose Magnesiumstearat 
Anhydrous lactose Microcrystalline cellulose (E460) Croscarmellose sodium Hypromellose (E-5) Magnesium stearate
Adjuverende monoterapi med capecitabin ved kolonkræft Data fra et randomiseret, kontrolleret, klinisk fase III-multicenterstudie hos patienter med kolonkræft i stadium III (Dukes' stadium C) støtter anvendelsen af capecitabin som adjuverende behandling af patienter med kolonkræft (XACT-Studie; M66001). 
Monotherapy with capecitabine in adjuvant colon cancer Data from one multicentre, randomised, controlled phase III clinical trial in patients with stage III (Dukes' C) colon cancer supports the use of capecitabine for the adjuvant treatment of patients with colon cancer (XACT Study; M66001).
Kombinationsterapi i 1. linjebehandling af metastatisk kolorektalkræft Data fra et multicenter, randomiseret, kontrolleret klinisk fase III-studie (NO16966) understøtter anvendelsen af capecitabin i kombination med oxaliplatin eller i kombination med oxaliplatin og bevacizumab til 1. linjebehandling af metastatisk kolorektalkræft. 
Combination therapy in first-line treatment of metastatic colorectal cancer Data from a multicentre, randomised, controlled phase III clinical study (NO16966) support the use of capecitabine in combination with oxaliplatin or in combination with oxaliplatin and bevacizumab for the first-line treatment of metastatic colorectal cancer.
For henholdsvis FOLFIRI plus bevacizumab og XELIRI plus bevacizumab var den mediane progressionfri overlevelse 10,0 og 8,9 måneder; p = 0,64, samlet overlevelse var 25,7 og 27,5 måneder; p = 0,55, og responsrater 45,5 % og 39,8 %; = 0,32. 
Median progression-free survival (PFS) was 10.0 and 8.9 months; p=0.64, overall survival 25.7 and 27.5 months; p=0.55 and response rates 45.5 and 39.8%; p=0.32 for FOLFIRI-Bev and XELIRI-Bev, respectively.
Urinvejs-infektion, Cellulitis, Tonsillitis, Faryngitis, Oral candidiasis, Influenza, Gastroenteritis, Svampeinfektion, Infektion, Tandbyld 
Pharyngitis, Oral candidiasis, Influenza, Gastroenteritis, Fungal infection, Infection, Tooth abscess
I testene hos den samlede randomiseringspopulation for forskel mellem capecitabin og 5-FU/LV mht. sygdomsfri og samlet overlevelse var hazard ratios hhv. 0,88 (95 % konfidensinterval 0,77 - 1,01; p = 0,068) og 0,86 (95 % konfidensinterval 0,74 - 1,01; p = 0,060). 
In the all-randomised population, tests for difference of capecitabine vs 5-FU/LV in disease-free and overall survival showed hazard ratios of 0.88 (95% CI 0.77 - 1.01; p = 0.068) and 0.86 (95% CI 0.74 - 1.01; p = 0.060), respectively.
I studierne blev 603 patienter randomiserede til behandling med capecitabin (1.250 mg/m2 to gange dagligt i 2 uger, efterfulgt af en uges pause, og givet som 3-ugers serier). 
In these trials, 603 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period and given as 3-week cycles).
Ødem i underekstremiteter, Hypertension, Embolisme og tromboser 
Lower limb oedema, Hypertension, Embolism and thrombosis
Resultaterne fra en metaanalyse af 14 kliniske studier med data fra mere end 4.700 patienter, som er blevet behandlet med capecitabin, viste at i alle studier kombineret, var stigende alder (ved 10-års forøgelse) statistisk signifikant associeret med en øget risiko for udviklingen af hånd- og fodsyndrom og diarré og med en faldende risiko for at udvikle neutropeni. 
The results of a meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine showed that in all studies combined, increasing age (by 10 year increments) was statistically significantly associated with an increased risk of developing HFS and diarrhoea and with a decreased risk of developing neutropenia.
(også i munden), influenza, maveinfluenza, tandbylder - knuder under huden (lipom) - fald i blodtal, inklusive blodplader, fortyndet blod (kan ses i blodprøve) - allergi - sukkersyge, nedsat indhold af kalium i blodet, underernæring, øget niveau af triglycerider i blodet - forvirring, panikanfald, depression, nedsat sexlyst, - talebesvær, dårlig hukommelse, koordinationsforstyrrelser, balanceforstyrrelser, besvimelse, 
fungal infections (including those of the mouth), influenza, gastroenteritis, tooth abscess - lumps under the skin (lipoma) - decreases in blood cells including platelets, thinning of blood (seen in tests) - allergy - diabetes, decrease in blood potassium, malnutrition, increased blood triglycerides - confusional state, panic attacks, depressed mood, decreased libido - difficulty speaking, impaired memory, loss of movement coordination, balance disorder,
Fremstiller: 
Manufacturer
PVC/PVdC/aluminium-blistere: Må ikke opbevares ved temperaturer over 30 °C. 
PVC/PVdC/aluminium blisters Do not store above 30°C.
Tabel 5 viser de bivirkninger, der er forbundet med anvendelsen af capecitabin administreret i kombination med forskellige kemoterapiregimer indenfor flere indikationer. 
Table 5 lists ADRs associated with the use of capecitabine in combination with different chemotherapy regimens in multiple indications based on safety data from over 3000 patients.
Hypokaliæmi, Hyponatriæmi, Hypomagnesiæmi, Hypokalcæmi, Hyperglycæmi 
Hypokalaemia, Hyponatraemia, Hypomagnesaemia,
Erythem, 
Petechiae,
Hvis der forekommer behandlingsrelaterede stigninger af bilirubin > 3,0 x UNL eller af hepatiske aminotransferaser (ALAT og ASAT) > 2,5 x UNL skal behandlingen med capecitabin straks afbrydes. 
Administration of capecitabine should be interrupted if treatment-related elevations in bilirubin of >3.0 x ULN or treatment-related elevations in hepatic aminotransferases (ALT, AST) of >2.5 x ULN occur.
I enkelte tilfælde er der, under samtidig behandling med capecitabin og phenytoin, rapporteret om stigninger i plasmakoncentrationerne af phenytoin, som har medført symptomer på fenytoinintoksikation. 
Phenytoin: increased phenytoin plasma concentrations resulting in symptoms of phenytoin intoxication in single cases have been reported during concomitant use of capecitabine with phenytoin.
Den anbefalede initialdosis ved capecitabin-monoterapi, til adjuverende behandling af kolonkræft, til behandling af metastatisk kolorektalkræft eller af lokalt fremskreden eller metastatisk brystkræft er 1.250 mg/m2 administreret to gange dagligt (morgen og aften, svarende til en daglig dosis på 2.500 mg/m2) i 14 dage, efterfulgt af 7 dages pause. 
Given as monotherapy, the recommended starting dose for capecitabine in the adjuvant treatment of colon cancer, in the treatment of metastatic colorectal cancer or of locally advanced or metastatic breast cancer is 1250 mg/m2 administered twice daily (morning and evening; equivalent to
Patienter bør monitoreres omhyggeligt for oftalmologiske komplikationer såsom keratitis og sygdomme på cornea. 
Ophthalmologic complications: Patients should be carefully monitored for ophthalmological complications such as keratitis and corneal disorders, especially if they have a prior history of eye disorders.