FrancophonIA/ELRC3.0 huggingface dataset:
English: Discontinuation of necitumumab in patients who experience a VTE or ATE should be considered after a thorough benefit risk assessment for the individual patient.
Croatian: Prekid liječenja necitumumabom u bolesnika koji imaju venske ili arterijske tromboembolijske događaje treba razmotriti nakon detaljne ocjene omjera koristi i rizika u pojedinog bolesnika.
English: Women of childbearing potential should be advised to avoid becoming pregnant while on necitumumab.
Croatian: Ženama reproduktivne dobi treba savjetovati da izbjegavaju trudnoću tijekom liječenja necitumumabom.
English: How you are given Portrazza 4.
Croatian: Kako ćete primati lijek Portrazza 4. Moguće nuspojave
English: Based on the results of the population pharamacokinetic analysis, there was no impact of age on necitumumab exposure.
Croatian: Rezultati populacijske farmakokinetičke analize pokazali su da dob nije utjecala na izloženost necitumumabu.
English: Table 1 - Management recommendations for hypersensitivity/infusion-related reactions
Croatian: Tablica 1 - Preporuke za zbrinjavanje reakcija preosjetljivosti/reakcija na infuziju
English: Following the dose regimen of 800 mg necitumumab on day 1 and day 8 of a 21 day schedule, the geometric mean of necitumumab Cmin was 98.5 μg/mL (Coefficient of Variation 80 %) in serum from patients with squamous NSCLC after five cycles of treatment in combination with gemcitabine and cisplatin.
Croatian: Nakon režima primjene necitumumaba u dozi od 800 mg 1. i 8. dana 21-dnevnog rasporeda, geometrijska srednja vrijednost Cmin necitumumaba u serumu bolesnika s planocelularnim NSCLC-om nakon pet ciklusa liječenja u kombinaciji s gemcitabinom i cisplatinom iznosila je 98,5 μg/ml
English: Effective contraception has to be used during necitumumab treatment and up to 3 months after last administration of necitumumab treatment.
Croatian: Potrebno je koristiti učinkovitu kontracepciju tijekom liječenja i do 3 mjeseca nakon posljednje primjene necitumumaba.
English: Portrazza is administered in addition to gemcitabine and cisplatin-based chemotherapy for up to 6 cycles of treatment followed by Portrazza as a single agent in patients whose disease has not progressed, until disease progression or unacceptable toxicity.
Croatian: Portrazza se primjenjuje kao dodatak kemoterapiji utemeljenoj na gemcitabinu i cisplatinu tijekom najviše 6 ciklusa liječenja, nakon čega se u bolesnika kojima bolest nije progredirala Portrazza primjenjuje kao monoterapija do progresije bolesti ili nastupa neprihvatljive toksičnosti.
English: Blood clots in the veins
Croatian: Krvni ugrušci u venama
English: There are no data on the effect of necitumumab on human fertility.
Croatian: Nema podataka o učinku necitumumaba na plodnost u ljudi.
English: Symptoms may include swelling, pain and tenderness of the limb, difficulty breathing, chest pain, or an abnormal heartbeat and discomfort.
Croatian: Simptomi mogu uključivati oticanje, bol i osjetljivost udova na dodir, otežano disanje, bolove u prsnom košu ili poremećene otkucaje srca i nelagodu.
English: Activation of EGFR has been correlated with malignant progression, induction of angiogenesis and inhibition of apoptosis or cell death.
Croatian: indukcijom angiogeneze i inhibicijom apoptoze ili stanične smrti.
English: Patients with significant coronary artery disease, myocardial infarction within 6 months, uncontrolled hypertension, and uncontrolled congestive heart failure were not enrolled in the pivotal study.
Croatian: U pivotalno ispitivanje nisu bili uključeni bolesnici sa značajnom bolešću koronarnih arterija, infarktom miokarda unutar prethodnih 6 mjeseci, nekontroliranom hipertenzijom i nekontroliranim kongestivnim zatajenjem srca.
English: In a phase 2 clinical trial investigating necitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone as the first-line therapy in patients with Stage IV metastatic squamous NSCLC, an increased rate of infections was observed early after start of treatment, which led to subsequent infectious complications such as pneumonia and/or sepsis.
Croatian: Infekcije U kliničkom ispitivanju faze 2 u kojem se ispitivao necitumumab u kombinaciji s paklitakselom i karboplatinom naspram samo paklitaksela i karboplatina u prvoj liniji liječenja bolesnika s metatatskim planocelularnim NSCLC-om stadija IV opažena je povećana stopa infekcija ubrzo nakon početka liječenja, koja je dovela do kasnijih infektivnih komplikacija poput pneumonije i/ili sepse.
English: ADRs reported in ≥ 1 % of necitumumab treated patients in SQUIRE
Croatian: Tablica 3. Nuspojave lijeka prijavljene u ≥ 1 % bolesnika liječenih necitumumabom u ispitivanju SQUIRE
English: - Blood levels of magnesium, calcium, potassium and phosphate During treatment, your doctor will check your blood periodically for levels of several substances such as magnesium, calcium, potassium and phosphate.
Croatian: Liječnik će Vam tijekom liječenja povremeno kontrolirati vrijednosti određenih tvari u krvi, poput magnezija, kalcija, kalija i fosfata.
English: • If symptoms do not worsen at 600 mg for another treatment cycle, the dose may be further increased to 800 mg.
Croatian: • Ako se simptomi ne pogoršaju uz primjenu doze od 600 mg tijekom još jednog ciklusa liječenja, ona se može povećati na
English: Blood clots can also lead to a blockage in the blood vessels of the lung.
Croatian: Krvni ugrušci mogu dovesti i do blokade krvnih žila u plućima.
English: Portrazza contains sodium
Croatian: Portrazza sadrži natrij
English: You must not be given Portrazza - if you have ever had a severe allergic reaction to necitumumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste ikada imali tešku alergičnu reakciju na necitumumab ili neki drugi sastojak ovog lijeka
English: • If symptoms do not worsen at 400 mg for at least 1 treatment cycle, the dose may be increased to 600 mg If symptoms worsen at 600 mg, temporarily withhold, for a maximum of 6 weeks following Day 1 of the most recent treatment cycle, until symptoms resolve to Grade ≤ 2.
Croatian: Ako se simptomi pogoršaju uz primjenu doze od 600 mg, privremeno odgoditi primjenu - za najviše 6 tjedana počevši od 1. dana posljednjeg ciklusa liječenja - dok se simptomi ne ublaže do ≤ 2. stupnja.
English: Vials contain 800 mg as a 16 mg/mL solution of necitumumab; one 50 mL vial contains the complete dose.
Croatian: Bočice sadrže 800 mg necitumumaba u obliku otopine koncentracije 16 mg/ml; jedna bočica od 50 ml sadrži cijelu dozu lijeka.
English: There are no data from the use of necitumumab in pregnant women.
Croatian: Trudnoća Nema podataka o primjeni necitumumaba u trudnica.
English: Severe VTEs were reported in approximately 4 % of patients.
Croatian: Teški VT događaji prijavljeni su u približno 4% bolesnika.
English: Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling.
Croatian: Bolesnike treba uputiti da potraže liječničku pomoć ako se razviju simptomi poput nedostatka zraka, bolova u prsištu te oticanja ruku ili nogu.
English: Patients should be instructed to seek medical care if they develop symptoms of thromboembolism such as shortness of breath, chest pain, arm or leg swelling.
Croatian: Bolesnike treba uputiti da zatraže liječničku skrb ako se razviju simptomi tromboembolije poput nedostatka zraka, bolova u prsištu, oticanja ruku ili nogu.
English: In patients who have experienced a previous Grade 1 or 2 hypersensitivity or infusion related reaction to Portrazza, premedication with a corticosteroid and an antipyretic in addition to an antihistamine is recommended.
Croatian: U bolesnika koji su tijekom prethodne primjene lijeka Portrazza doživjeli reakciju preosjetljivosti ili reakciju na infuziju 1. ili 2. stupnja, preporučuje se premedikacija kortikosteroidom i antipiretikom te antihistaminikom.
English: The incremental risk of cardiopulmonary arrest or sudden death in patients with a history of coronary artery disease, congestive heart failure, or arrhythmias as compared to those without these comorbid conditions is not known.
Croatian: Nije poznat dodatno povećan rizik od kardiopulmonalnog zastoja ili iznenadne smrti u bolesnika koji u anamnezi imaju bolest koronarnih arterija, kongestivno zatajenje srca ili aritmije u odnosu na one koji nemaju ta komorbiditetna stanja.
English: Rare (≥1/10,000 to <1/1,000)
Croatian: manje često (≥ 1/1000 i < 1/100) rijetko (≥ 1/10 000 i < 1/1000) vrlo rijetko (<1/10 000)
English: There are no data regarding necitumumab administration in patients with moderate or severe hepatic impairment (see section 5.2).
Croatian: Nema podataka o primjeni necitumumaba u bolesnika s umjerenim ili teškim oštećenjem jetrene funkcije (vidjeti dio 5.2).
English: The onset of events usually occurred after the first or second administration of necitumumab.
Croatian: One su se obično javljale nakon prve ili druge primjene necitumumaba.
English: Management recommendations (any occurrence)
Croatian: Broj događaja (n)
English: No other formal interaction studies with necitumumab have been performed in humans.
Croatian: Nisu provedena druga formalna ispitivanja interakcija između necitumumaba i drugih lijekova u ljudi.
English: Discard any unused portion of necitumumab left in a vial, as the product contains no antimicrobial preservatives.
Croatian: Bacite sav neupotrijebljen necitumumab preostao u bočici jer lijek ne sadrži antimikrobne konzervanse.
English: A similar observation was made in a clinical trial investigating necitumumab in combination with pemetrexed and cisplatin versus pemetrexed and cisplatin alone as the first-line therapy in patients with advanced non-squamous NSCLC.
Croatian: Slično je opaženo i u kliničkom ispitivanju u kojem se ispitivao necitumumab u kombinaciji s pemetreksedom i cisplatinom naspram samo pemetrekseda i cisplatina u prvoj liniji liječenja bolesnika s uznapredovalim neplanocelularnim NSCLC-om.
English: There is no known antidote for necitumumab overdose.
Croatian: Nema poznatog protulijeka za predoziranje necitumumabom.
English: What Portrazza contains - The active substance is necitumumab.
Croatian: Što Portrazza sadrži - Djelatna tvar je necitumumab.
English: Based on the results of the population pharmacokinetic analysis, there was no impact of renal function as assessed by creatinine clearance [CrCl] on the pharmacokinetics of necitumumab.
Croatian: Rezultati populacijske farmakokinetičke analize pokazali su da bubrežna funkcija ocijenjena na temelju klirensa kreatinina (CrCl) nije utjecala na farmakokinetiku necitumumaba.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial of 50 mL contains 800 mg necitumumab (16 mg/mL).
Croatian: Jedna bočica od 50 ml sadrži 800 mg necitumumaba (16 mg/ml).
English: Severe skin rections were reported in approximately 6 % of patients while 1.7 % of patients discontinued due to skin reactions.
Croatian: dok je 1,7% bolesnika prekinulo liječenje zbog kožnih reakcija.
English: Symptoms may include difficulty breathing, chest pain, or an abnormal heartbeat and discomfort.
Croatian: Simptomi mogu uključivati otežano disanje, bolove u prsnom košu ili poremećene srčane otkucaje i nelagodu.
English: Arterial thromboembolic events (ATEs) were reported in approximately 4 % of patients and mainly present as stroke and myocardial infarction.
Croatian: Arterijski tromboembolijski (AT) događaji prijavljeni su u približno 4% bolesnika, a uglavnom su se manifestirali kao moždani udar i infarkt miokarda.
English: Severe ATEs were reported in 3 % of patients.
Croatian: Teški AT događaji prijavljeni su u 3% bolesnika.
English: In patients with no detectable EGFR protein expression, no improvement in overall survival (hazard ratio [HR] = 1.52 [0.74, 3.12]) or progression free survival (hazard ratio [HR] = 1.33 [0.65, 2.70] was observed.
Croatian: (omjer hazarda [HR] = 1,52 [0,74; 3,12]) niti preživljenja bez progresije bolesti (omjer hazarda [HR] =
English: Distribution of Portrazza follow a biphasic decline.
Croatian: Distribucija lijeka Portrazza slijedi pad u dvije faze.
English: Infusion-related reactions were reported in 1.5 % of patients and mainly present as chills, fever or dyspnoea.
Croatian: Reakcije na infuziju prijavljene su u 1,5% bolesnika, a uglavnom su se manifestirale kao zimica,
English: o Description of cardiorespiratory disorders including incidence rates from clinical trials o Information that the incremental risk of cardiopulmonary arrest or sudden death in patients with a history of coronary artery disease, congestive heart failure, or arrhythmias as compared to those without these comorbid conditions is not known.
Croatian: o Opis kardiorespiratornih poremećaja, uključujući stope incidencije u kliničkim ispitivanjima o Informaciju o tome da nije poznat dodatno povećan rizik od kardiopulmonalnog zastoja ili iznenadne smrti u bolesnika koji u anamnezi imaju bolest koronarnih arterija, kongestivno zatajenje srca ili aritmije u odnosu na one koji nemaju ta komorbiditetna stanja o Naputak zdravstvenim radnicima da te materijale čitaju zajedno sa Sažetkom opisa svojstava lijeka.
English: Necitumumab therapy must be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Croatian: 4.2 Doziranje i način primjene Necitumumab se mora primjenjivati pod nadzorom liječnika koji je kvalificiran za primjenu kemoterapije za liječenje raka.
English: Venous thromboembolic events (VTEs) were reported in approximately 8 % of patients and mainly present as pulmonary embolism and deep vein thrombosis.
Croatian: Venski tromboembolijski (VT) događaji prijavljeni su u približno 8% bolesnika, a uglavnom su se manifestirali kao plućna embolija i duboka venska tromboza.
English: It is unknown whether necitumumab is excreted in human milk.
Croatian: Nije poznato izlučuje li se necitumumab u majčino mlijeko.
English: Any grade
Croatian: Svi stupnjevi stupanj
English: Dose dependent reversible skin toxicity was observed in the 26-week monkey study.
Croatian: U 26-tjednom ispitivanju na majmunima primijećena je reverzibilna toksičnost za kožu ovisna o dozi.
English: In a clinical trial in advanced non-squamous NSCLC, venous thromboembolic events (VTEs) were reported in approximately 11 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 8 % in the pemetrexed and cisplatin alone arm) and mainly presented as pulmonary embolism and deep vein thrombosis.
Croatian: U kliničkom ispitivanju kod uznapredovalog neplanocelularnog NSCLC-a, venski tromboembolijski (VT) događaji prijavljeni su u približno 11% bolesnika liječenih necitumumabom u kombinaciji s pemetreksedom i cisplatinom (naspram 8% onih u skupini liječenoj samo pemetreksedom i cisplatinom), a manifestirali su se uglavnom kao plućna embolija i duboka venska tromboza.
English: Adverse drug reactions (ADRs) which were reported in patients with squamous non-small cell lung cancer are listed below in MedDRA body system organ class, frequency and grade of severity.
Croatian: Nuspojave prijavljene u bolesnika s planocelularnim rakom pluća nemalih stanica navedene su u nastavku prema MedDRA klasifikaciji organskih sustava, učestalosti i stupnju težine.
English: You may be given medicines to reduce the risk of an infusion-related reaction or a skin reaction before you receive Portrazza.
Croatian: Prije nego što primite lijek Portrazza, možda ćete primiti lijekove koji će smanjiti rizik od pojave reakcije na infuziju ili kožne reakcije.
English: System organ class
Croatian: Organski sustav Učestalost
English: Cardiovascular comorbidities, performance status and the likely tolerability to chemotherapy with add-on necitumumab should therefore be thoroughly evaluated prior to the initiation of treatment in patients above 70 years of age.
Croatian: Stoga u bolesnika starijih od 70 godina treba prije početka liječenja temeljito ocijeniti kardiovaskularne komorbiditete, funkcionalni status i vjerojatnu podnošljivost kemoterapije uz dodatak necitumumaba.
English: Appropriate medical resources for the treatment of severe infusion reactions should be available during necitumumab infusions.
Croatian: Tijekom infuzija necitumumaba na raspolaganju trebaju biti odgovarajući medicinski resursi za liječenje teških reakcija na infuziju.
English: Women of childbearing potential/contraception in females Based on its mechanism of action and animal models where EGFR expression is disrupted, necitumumab may cause foetal harm or developmental anomalies.
Croatian: S obzirom na mehanizam djelovanja i životinjske modele u kojima je ekspresija EGFR-a poremećena, necitumumab može naškoditi plodu ili uzrokovati razvojne anomalije.
English: Progression free survival Number of events (n) Median - months (95 % CI) Hazard ratio (95 % CI) b, c Two-sided log-rank p-value c a Abbreviations: CI = confidence interval b Hazard ratio is expressed as treatment/control and estimated from Cox model c Stratified by the randomization strata (ECOG PS [0-1 vs. 2], and geographic region [North
Croatian: Dvostrana log-rang p-vrijednost c a Kratice: CI = interval pouzdanosti b Omjer hazarda izražava se kao omjer između liječene i kontrolne skupine, a procjenjuje se na temelju Coxova modela c Stratificirano prema randomizacijskim stratumima (funkcionalni ECOG status [0 - 1 naspram 2]
English: Each mL of concentrate for solution for infusion contains 16 mg of necitumumab.
Croatian: Jedan ml koncentrata za otopinu za infuziju sadrži 16 mg necitumumaba.
English: Detailed instructions for your doctor or your nurse on how to prepare Portrazza infusion are included at the end of this package leaflet (see ‘Handling instructions').
Croatian: Portrazza nalaze se na kraju ove upute (pogledajte odlomak 'Upute za rukovanje').
English: The pharmacokinetics of gemcitabine/cisplatin were not affected when co-administered with necitumumab and the pharmacokinetics of necitumumab were not affected when co-administered with gemcitabine/cisplatin.
Croatian: Istodobna primjena necitumumaba nije utjecala na farmakokinetiku gemcitabina/cisplatina, jednako kao što ni istodobna primjena gemcitabina/cisplatina nije utjecala na farmakokinetiku necitumumaba.
English: This medicine is given as an intravenous (into a vein) infusion via a drip.
Croatian: Ovaj se lijek primjenjuje kao intravenska infuzija ukapavanjem u venu (drip), a traje približno 60 minuta.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Portrazza 800 mg sterile concentrate necitumumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Portrazza 800 mg sterilni koncentrat necitumumab
English: Symptoms may include swelling, pain and tenderness of the limb.
Croatian: Simptomi mogu uključivati oticanje, bol i osjetljivost udova na dodir.
English: o The need to carefully consider use of necitumumab in patients with a history of thromboembolic events or pre-existing risk factors for thromboembolic events o Information on relative risk of VTE or ATE in patients with a history of VTE or ATE o Advice that necitumumab should not be administered to patients with multiple risk factors for thromboembolic events unless the benefits outweigh the risks to the patient o The need to consider thromboprophylaxis after careful assessment of a patient's risk factors o Discontinuation of necitumumab in patients who experience a VTE or ATE should be considered after a thorough benefit risk assessment for the individual patient.
Croatian: AT događaja o Preporuku da se necitumumab ne smije primjenjivati bolesnicima s višestrukim faktorima rizika za tromboembolijske događaje, osim ako koristi od liječenja nadmašuju rizike za bolesnika o Potrebu da se razmotri tromboprofilaksa nakon pažljive ocjene bolesnikovih faktora rizika o Potrebno je razmotriti prekid liječenja necitumumabom u bolesnika u kojih nastupi VT ili
English: In approximately 5 out of 100 patients these skin reactions are likely to be severe.
Croatian: Te će kožne reakcije vjerojatno biti teške u približno 5 od 100 bolesnika.
English: Very common (may affect more than 1 in 10 people): - itching; dry skin; scaling; nail disorders (skin reactions) - vomiting - fever or high temperature (pyrexia) - decreased weight - mouth ulcers and cold sores (stomatitis)
Croatian: - svrbež, suha koža, ljuskanje kože, poremećaji noktiju (kožne reakcije) - povraćanje - vrućica ili visoka tjelesna temperatura (pireksija)
English: Abbreviations: C = cisplatin; G = gemcitabine; ITT = intent-to-treat.
Croatian: Kratice: C = cisplatin; G = gemcitabin; ITT = populacija koju se namjeravalo liječiti
English: A doctor experienced in the use of anti-cancer medicines will supervise your Portrazza therapy.
Croatian: Kako ćete primati lijek Portrazza Terapiju lijekom Portrazza nadzirat će liječnik s iskustvom u primjeni lijekova za liječenje raka.
English: Hypersensitivity/Infusion-related reactions
Croatian: Reakcije preosjetljivost/reakcije na infuziju
English: Each millilitre of the concentrate for solution for infusion contains 16 mg of necitumumab.
Croatian: Jedan mililitar koncentrata za otopinu za infuziju sadrži 16 mg necitumumaba.
English: Each 50 mL vial contains 800 mg of necitumumab.
Croatian: Jedna bočica od 50 ml sadrži 800 mg necitumumaba.
English: In a clinical trial in advanced non-squamous NSCLC, patients experienced an increased rate of serious thromboembolic events (including fatal events) in the necitumumab plus pemetrexed and cisplatin arm as compared to the pemetrexed and cisplatin arm (see also section 4.8).
Croatian: U kliničkom ispitivanju kod uznapredovalog neplanocelularnog NSCLC-a, bolesnici u skupini liječenoj necitumumabom plus pemetreksedom i cisplatinom imali su veću stopu ozbiljnih tromboembolijskih događaja (uključujući događaje sa smrtnim ishodom) nego oni u skupini liječenoj samo pemetreksedom i cisplatinom (vidjeti i dio 4.8).
English: It is available in packs of: - 1 vial of 50 mL
Croatian: Dostupna je u pakiranjima od:
English: Patients were randomised to receive first-line Portrazza at 800 mg plus chemotherapy consisting of gemcitabine at 1,250 mg/m2 and cisplatin at 75 mg/m2 (Portrazza+GC Arm), or gemcitabine-cisplatin chemotherapy alone (GC Arm).
Croatian: Bolesnici su bili randomizirani u skupine koje su kao prvu liniju terapije primale lijek Portrazza u dozi od 800 mg plus kemoterapiju koja se sastojala od gemcitabina u dozi od 1250 mg/m2 i cisplatina u dozi od 75 mg/m2
English: NAME OF THE MEDICINAL PRODUCT Portrazza 800 mg concentrate for solution for infusion
Croatian: NAZIV LIJEKA Portrazza 800 mg koncentrat za otopinu za infuziju
English: Clinically relevant toxicities with respect to the elderly and those patients with Eastern Cooperative Oncology Group (ECOG) performance status score 2 (ECOG PS2) were similar to the overall population in patients receiving necitumumab plus chemotherapy consisting of gemcitabine and cisplatin.
Croatian: Eastern Cooperative Oncology Group) status 2 bile su slične onima primijećenima u cjelokupnoj populaciji bolesnika liječenih necitumumabom plus kemoterapijom koja se sastojala od gemcitabina i cisplatina.
English: Twelve of the fifteen patients died within 30 days of the last dose of necitumumab and had comorbid conditions including history of coronary artery disease (n=3), hypomagnesemia (n=4), chronic obstructive pulmonary disease (n=7), and hypertension (n=5).
Croatian: Dvanaest od tih 15 bolesnika umrlo je unutar 30 dana nakon posljednje doze necitumumaba, a imalo je komorbiditetna stanja, uključujući bolest koronarnih arterija
English: Venous thromboembolic events (VTE) and arterial thromboembolic events (ATE), including fatal cases, were observed with necitumumab in combination with gemcitabine and cisplatin (see also section 4.8).
Croatian: Kod primjene necitumumaba u kombinaciji s gemcitabinom i cisplatinom prijavljeni su venski tromboembolijski (VT) događaji i arterijski tromboembolijski (AT) događaji, uključujući slučajeve sa smrtnim ishodom (vidjeti i dio 4.8).
English: Vascular disorders Common Venous thromboembolic events
Croatian: Krvožilni poremećaji često venski tromboembolijski događaji često arterijski tromboembolijski događaji često flebitis
English: If symptoms worsen at 400 mg, permanently discontinue.
Croatian: 400 mg, trajno prekinuti liječenje.