natgillin/translations-raw huggingface dataset:
The results from the in vitro CYP450 inhibition study indicate amifampridine is unlikely to play a role in metabolic-based clinical drug-drug interactions related to inhibition of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4 metabolism of co-administered medicinal products. 
Rezultati in vitro studije s inhibicijom CYP450 ukazuju da je malo vjerojatno da amifampridin ima ulogu u metaboličkim kliničkim interakcijama lijekova povezanim s inhibicijom CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 i CYP3A4 metaboliziranja istodobno primijenjenih lijekova.
The most commonly reported adverse reactions are paraesthesias (such as peripheral and peribucal paraesthesias) and gastro-intestinal disorders (such as epigastralgia, diarrhoea, nausea and abdominal pain). 
Najčešće zabilježene nuspojave su parestezije (poput periferne i peribukalne parestezije) i poremećaji probavnog sustava (poput epigastralgije, proljeva, mučnine i boli u abdomenu).
• Medicines for malaria (e.g. halofantrine and mefloquine) 
• lijekove za malariju (primjerice, halofantrin i meflokin)
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Perforated unit dose thermoformed blisters 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Termoformirani perforirani blister s jediničnim dozama
• Chorea (movement disorder), myoclonia (muscle spasm or twitching) 
• koreja (poremećaj pokreta), mioklonija (grčevi ili trzanje mišića)
Medicinal products with atropinic effects 
Lijekovi s atropinskim učincima
Assessment 
Ocjena
No impairment of fertility has been observed in non-clinical studies with amifampridine (see section 5.3). 
Nije uočeno smanjenje plodnosti u nekliničkim ispitivanjima amifampridina (vidjeti dio 5.3).
Available reproductive data in animals have shown presence of amifampridine in milk of breast-feeding mothers. 
Dostupni podaci o reproduktivnosti u životinja pokazali su prisutnost amifampridina u mlijeku životinja koje doje.
Cardiac disorders Cardiac rhythm disorders, palpitations 
Poremećaji srčanog ritma, palpitacije
FIRDAPSE works by increasing the release of acetylcholine and helps the muscle to receive the nerve signals. 
FIRDAPSE djeluje tako da povećava oslobađanje acetilkolina te pomaže da mišić primi živčane signale.
The 3-N-acetyl metabolite exposure by AUC0-∞ was up to 6.8-fold higher in slow acetylators and up to 4-fold higher in fast acetylators with severe renal impairment compared to subjects with normal renal function. 
Izloženost 3-N-acetil metabolitu prema AUC0-∞ bila je do 6,8 puta veća u sporih acetilatora i do 4 puta veća u brzih acetilatora s teškim oštećenjem funkcije bubrega u usporedbi s ispitanicima s normalnom funkcijom bubrega.
Bioavailability is approximately 93-100% based on recoveries of unmetabolised amifampridine and a major 3-N-acetylated amifampridine metabolite in urine. 
Bioraspoloživost iznosi približno 93-100% na temelju izlučenog nemetaboliziranog amifampridina i glavnog metabolita 3-N-acetiliranog amifampridina u mokraći.
Store in the original blister in order to protect from light and moisture. 
Čuvati u originalnom blisteru radi zaštite od svjetlosti i vlage.
In view of the risk of markedly increased exposure to medicinal product, patients with renal or hepatic impairment must be carefully monitored. 
Imajući u vidu rizik od značajne izloženosti lijeku, bolesnike s oštećenjem funkcije bubrega ili jetre mora se pomno pratiti.
• Medicines to treat allergies - antihistamines (e.g. terfenadine, astemizole, cimetidine) 
• lijekove za liječenje alergija - antihistaminike (primjerice, terfenadin, astemizol, cimetidin)
A 2-fold increase in the time to reach Cmax (Tmax) was observed in the presence of food. 
U prisutnosti hrane uočeno je dvostruko produljenje vremena do postizanja Cmax (Tmax).
• Anxiety, sleep disorders, drowsiness 
• tjeskoba, poremećaji spavanja, omamljenost
If any side effects occur, please consult your doctor as you may need to stop increasing the dose. 
U slučaju nuspojava obratite se svom liječniku jer će morati prekinuti povećavanje doze.
Fast 
Brzi
In a 2-year dietary carcinogenicity study, benign and malignant Schwannomas have been observed in rats treated with amifampridine (see section 5.3). 
U dvogodišnjem ispitivanju kancerogenosti provedenom s djelatnom tvari u hrani, benigni i maligni švanomi uočeni su u štakora liječenih amifampridinom (vidjeti dio 5.3).
Summary of Changes in Primary and Secondary Efficacy Endpoints from Baseline 
Sažetak promjena u primarnim i sekundarnim mjerama ishoda djelotvornosti u odnosu na početnu vrijednost
Observed mean difference in QMG Total and SGI change from baseline score between treatments were -6.54 (95% CI: -9.78, -3.29; p=0.0004) and 2.95 (95% CI: 1.53, 4.38; p=0.0003) respectively, both statistically significant in favour of amifampridine phosphate. 
Zapažena srednja vrijednost razlike u rezultatu ukupnog QMG-a u odnosu na početnu vrijednost, u razdoblju između liječenja, iznosila je -6,54 (95% CI: -9,78, -3,29; p = 0,0004), dok je srednja vrijednost promjene SGI-a u odnosu na početnu vrijednost u razdoblju između liječenja iznosila 2,95 (95% CI: 1,53, 4,38; p = 0,0003).
It is unknown whether amifampridine is excreted in human breast milk. 
Nije poznato izlučuje li se amifampridin u majčino mlijeko u ljudi.
Table 1: Adverse Reactions Reported with FIRDAPSE 
Tablica 1: Nuspojave prijavljene za lijek FIRDAPSE
• Antidepressants - tricyclic antidepressants (e.g. clomipramine, amoxapine), selective serotonin reuptake inhibitors (e.g. citalopram, dapoxetine) and atypical antidepressants (e.g. buproprion) 
• antidepresive - tricikličke antidepresive (primjerice, klomipramin, amoksapin), selektivne inhibitore ponovne pohrane serotonina (primjerice, citalopram, dapoksetin) i atipične antidepresive (primjerice, bupropion)
• Together with medicines that may change the electrical activity of your heart (QT-interval prolongation - detectable in the electrocardiogram), such as:  Sultropride (a medicine prescribed to treat certain behavioural disorders in adults),  Antiarrhythmic medicine (e.g., disopyramide)  Medicines to treat digestive problems (e.g., cisapride, domperidone) 
• zajedno s lijekovima koji mogu promijeniti električnu aktivnost Vašeg srca (produljenje QT intervala - vidljivo na EKG-u), poput:  sultoprida (lijeka koji se propisuje za liječenje nekih poremećaja ponašanja u odraslih osoba),  antiaritmika (npr. dizopiramid)  lijekova za liječenje probavnih smetnji (npr. cisaprid, domperidon)
Fed* (N=46) 
poslije jela* (N=46)
Substances which are potent inducers of enzymes that metabolise medicinal products (see section 5.2) The results from in vitro studies suggest there is low potential for drug-drug interactions due to enzyme induction of CYP1A2, CYP2B6, and CYP3A4 enzymes by amifampridine. 
Tvari koje su potentni induktori enzima koji metaboliziraju lijekove (vidjeti dio 5.2) Rezultati iz in vitro ispitivanja ukazuju da je potencijal za interakcije lijekova nizak zbog indukcije enzima CYP1A2, CYP2B6 i CYP3A4 putem amifampridina.
• Tramadol (a painkiller) 
• tramadol (lijek protiv bolova)
The dose of amifampridine should be titrated more slowly in patients with renal and hepatic impairment than those with normal renal and hepatic function. 
Dozu amifampridina treba titrirati sporije u bolesnika s oštećenjem funkcije bubrega ili jetre nego u onih s normalnom funkcijom bubrega ili jetre.
No adequate clinical data on exposed pregnancies are available for amifampridine. 
Nisu dostupni odgovarajući klinički podaci o izlaganju amifampridinu tijekom trudnoće.
Diarrhoea, epigastralgia 
Proljev, epigastralgija
NAME OF THE MEDICINAL PRODUCT FIRDAPSE 10 mg tablets 
NAZIV LIJEKA FIRDAPSE 10 mg tablete
No studies have been conducted in patients with hepatic impairment. 
Nisu provedena ispitivanja na bolesnicima s oštećenjem funkcije jetre.
There are no data on the pharmacokinetics of amifampridine in paediatric patients (see sections 4.2). 
Nema podataka o farmakokinetici amifampridina u pedijatrijskih bolesnika (vidjeti dio 4.2).
Patients should be titrated more slowly than those without renal or hepatic impairment with doses increased in 5 mg increments every 7 days. 
Bolesnike treba titrirati sporije nego one bez oštećenja funkcije bubrega ili jetre, uz povećavanje doze po 5 mg svakih 7 dana.
The concomitant use of amifampridine and medicinal products with atropinic effects may reduce the effect of both active substances and should be taken into consideration. 
Istodobna uporaba amifampridina i lijekova s atropinskim učincima može smanjiti učinak obje djelatne tvari te to treba uzeti u obzir.
 Medicines to treat infections - antibiotics (e.g., rifampicin) and antifungals (e.g., ketoconazole) 
 lijekova za liječenje infekcija - antibiotici (npr. rifampicin) i antimikotici (npr. ketokonazol)
Abdominal pain 
Bolovi u abdomenu
How to store FIRDAPSE 
Kako čuvati FIRDAPSE
The overall clearance of amifampridine is predominantly due to metabolism by N-acetylation and acetylator phenotype has a greater effect on an individual's metabolism and elimination of amifampridine than does elimination by renal function (See Table 4). 
Ukupan klirens amifampridina najvećim dijelom ovisi o metabolizmu putem N-acetilacije te fenotip acetilatora ima veći utjecaj na metabolizam i eliminaciju amifampridina u pojedinca nego što ima eliminacija putem bubrežne funkcije (vidjeti tablicu 4).
b SGI is a 7-point scale which rates the global impression of the effects of study treatment 
b SGI je ljestvica od 1 do 7 koja ocjenjuje opći dojam o učincima ispitivanog lijeka (1 = izrazito loš do 7 = izrazito dobar).
• Medicines for mental problems (e.g. haloperidol, carbamazapine, chlorpromazine, clozapine) 
• lijekove za psihičke probleme (primjerice haloperidol, karbamazepin, klorpromazin, klozapin)
There are no data on the pharmacokinetics of amifampridine in patients with hepatic impairment (see sections 4.2 and 4.4). 
Nema podataka o farmakokinetici amifampridina u bolesnika s oštećenjem funkcije jetre (vidjeti dijelove 4.2 i 4.4).
Upward dose titration should be discontinued if any adverse reaction or ECG abnormality is observed. 
Povećanje doze treba prekinuti u slučaju nuspojava ili nepravilnosti u EKG-u.
• Medicines to treat Parkinson's disease - anticholinergics (e.g. trihexylphenidyl, mesylate), 
• lijekove za liječenje Parkinsonove bolesti - antikolinergike (primjerice, triheksilfenidil, mesilat),
The concomitant use of amifampridine and medicinal products with cholinergic effects (e.g. direct or indirect cholinesterase inhibitors) may lead to an increased effect of both products and should be taken into consideration. 
Istodobna uporaba amifampridina i lijekova s kolinergičkim učincima (primjerice izravnih ili neizravnih inhibitora kolinesteraze) može uzrokovati pojačani učinak oba lijeka i to treba uzeti u obzir.
In contrast, the 3-N-acetyl metabolite exposure levels were affected to a greater extent by renal impairment than those for amifampridine. 
Nasuprot tome, na razine izloženosti 3-N-acetil metabolitu oštećenje funkcije bubrega imalo je značajniji utjecaj nego na izloženost amifampridinu.
Amifampridine exposure by AUC0-∞ was up to 2-fold higher in slow acetylators and up to 3-fold higher in fast acetylators with severe renal impairment compared to subjects with normal renal function. 
Izloženost amifampridinu prema AUC0-∞ bila je dvostruko veća u sporih acetilatora i do 3 puta veća u brzih acetilatora s teškim oštećenjem bubrežne funkcije u usporedbi s ispitanicima s normalnom funkcijom bubrega.
Table 3: Mean PK Parameters of Amifampridine in Healthy Subjects after Single Oral Doses (5-30mg) in Slow and Fast Acetylator Phenotypes 
Tablica 3: Srednja vrijednost farmakokinetičkih parametara amifampridina u zdravih ispitanika nakon jednokratnih peroralnih doza (5-30 mg) kod fenotipa brzih i sporih acetilatora
Similarly Cmax and AUC0-∞ were greater in the fasted state than in the fed state. 
Slično tome, Cmax i AUC0-∞ bile su veće nakon uzimanja natašte nego poslije jela.
Frequencies were estimated based on a clinical study to evaluate the effects of amifampridine on cardiac repolarization at a single dose of 30 mg or 60 mg in healthy volunteers. 
Učestalosti su procijenjene na temelju kliničkog ispitivanja za procjenu učinaka amifampridina na repolarizaciju srca u jednokratnoj dozi od 30 mg ili 60 mg u zdravih dobrovoljaca.
If you experience any of these symptoms, you should contact your doctor or pharmacist immediately. 
Ako se pojave ovi simptomi, odmah se obratite svom liječniku ili ljekarniku.
Table 2: PK Parameters for Amifampridine in Fed and Fasted Subjects Following Administration of a Single Oral Dose of Amifampridine Phosphate 
Tablica 2: PK parametri za amifampridin kod uzimanja poslije jela ili natašte nakon primjene jednokratne peroralne doze amifampridin fosfata
INFORMATION IN BRAILLE FIRDAPSE 
16. PODACI NA BRAILLEOVOM PISMU FIRDAPSE
Concomitant diseases 
Istodobne bolesti
It is not known whether FIRDAPSE is excreted in human breast milk. 
Nije poznato izlučuje li se FIRDAPSE u majčino mlijeko kod ljudi.
Exposure by Cmax was marginally affected by renal impairment regardless of acetylation status. 
Na izloženost prema Cmax oštećenje funkcije bubrega imalo je neznatan utjecaj, neovisno o statusu acetilatora.
Potent cytochrome P450 (CYP450) enzyme inhibitors e.g. cimetidine, ketoconazole are not likely to inhibit the metabolism of amifampridine by human N-acetyl-transferase enzymes (NATs) giving rise to increased amifampridine exposure. 
Tvari koje su potentni inhibitori enzima koji metaboliziraju lijekove (vidjeti dio 5.2) Nije vjerojatno da će potentni inhibitori enzima P450 (CYP450) poput cimetidina i ketokonazola inhibirati metabolizam amifampridina putem humanih enzima N-acetiltransferaza (NAT) što uzrokuje porast izloženosti amifampridinu.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 10 mg amifampridina u obliku amifampridinfosfata.
The pharmacokinetics of amifampridine has been assessed in a single dose Phase I study in patients with renal impairment (see section 5.2). 
Farmakokinetika amifampridina bila je ocijenjena u ispitivanju faze I primjene jednokratne doze u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2).
• Concomitant use with medicinal products with a narrow therapeutic window (see section 4.5) 
• Istodobna primjena s lijekovima uskog terapijskog raspona (vidjeti dio 4.5).
Psychiatric disorders Sleep disorders, anxiety 
Poremećaji spavanja, anksioznost
1 Adverse reactions reported in a clinical study to evaluate the effects of amifampridine on cardiac repolarization at a single dose of 30 mg or 60 mg in healthy volunteers. 
1Nuspojave zabilježene u kliničkom ispitivanju za procjenu učinka amifampridina na repolarizaciju srca u jednokratnoj dozi od 30 mg ili 60 mg u zdravih dobrovoljaca.
NAME OF THE MEDICINAL PRODUCT FIRDAPSE 10 mg tablets amifampridine 
NAZIV LIJEKA FIRDAPSE 10 mg tablete amifampridin
Concomitant use of medicinal products with a narrow therapeutic window is contraindicated (see section 4.3). 
Istodobna primjena s lijekovima uskog terapijskog raspona (vidjeti dio 4.3) je kontraindicirana.
• Medicines that may change the electrical activity of your heart (QT-interval prolongation detectable in the electrocardiogram) e.g., sultopride, disopyramide, cisapride, domperidone, 
• lijekovi koji mogu promijeniti električnu aktivnost Vašeg srca (produljeni QT-interval - može se otkriti elektrokardiogramom), npr. sultoprid, dizopiramid, cisaprid, domperidon, rifampicin i ketokonazol (pogledajte „Nemojte uzimati FIRDAPSE“)
The primary endpoints were change from baseline (CFB) in Patient Global Impression (SGI) and Quantitative Myasthenia Gravis (QMG) score at Day 4. 
Mjere primarnog ishoda bili su promjena u odnosu na početnu vrijednost (engl. change from baseline, CFB) na ljestvici općeg dojma bolesnika (subject global impression, SGI) i kvantitativnoj ljestvici miastenije gravis (engl. quantitative myasthenia gravis, QMG) na dan 4. Mjera sekundarnog ishoda djelotvornosti bila je promjena u općem kliničkom dojmu poboljšanja u odnosu na početnu vrijednosti (engl. clinical global impression - improvement, CGI-I) na dan 4, koju su odredili nadležni liječnici.
Medicinal products with cholinergic effects 
Lijekovi s kolinergičkim učincima
Medicinal products with atropinic effects include tricyclic anti-depressants, most H1 atropinic anti-histamines, anticholinergic, 
Lijekovi s atropinskim učincima uključuju tricikličke antidepresive, većinu H1 atropinskih antihistaminika, antikolinergika, lijekova protiv Parkinsonove bolesti, atropinskih antispazmodika, dizopiramida, fenotiazinskih neuroleptika i klozapina.
A double-blind, placebo-controlled, randomized withdrawal Study to evaluate the efficacy and safety of amifampridine phosphate in Patients with LEMS was conduct in adult patients 18 years of age or older (n=26). 
Dvostruko slijepo, randomizirano placebom kontrolirano ispitivanje s prekidom uzimanja lijeka bilo je provedeno u odraslih bolesnika s LEMS-om u dobi od 18 i više godina (n = 26) radi ocjene djelotvornosti i sigurnosti amifampridinfosfata.
If you have any doubts, ask your doctor or pharmacist for advice. 
Ako niste sigurni, obratite se za savjet svom liječniku ili ljekarniku.
Table 4: Mean PK Parameters of Amifampridine in Normal and Renal Impaired Subjects after Single Oral Dose Administration (10mg) in Slow and Fast Acetylator Phenotypes 
Tablica 4: Srednje vrijednosti farmakokinetičkih parametara amifampridina u ispitanika s normalnom i oštećenom funkcijom bubrega nakon primjene jednokratne peroralne doze (10 mg) kod fenotipa sporih i brzih acetilatora
• Liver problems 
• poteškoće s jetrom
Upward dose titration should be discontinued if any adverse reaction occurs (see section 4.2). 
Ako se javi bilo koja nuspojava, titriranje doze naviše treba prekinuti (vidjeti dio 4.2).
AUC0-∞ (ng·hr/ml) Mean (S.D.), range 
AUC0-∞ (ng·hr/ml) srednja vrijednost (S.D.), raspon
FIRDAPSE should be used with caution in patients with renal or hepatic impairment. 
FIRDAPSE treba primijeniti s oprezom u bolesnika s oštećenjem funkcije bubrega ili jetre.
For patients with mild impairment of renal or hepatic function, a starting dose of 10 mg amifampridine (5 mg twice a day) per day is recommended. 
U bolesnika s blagim oštećenjem funkcije bubrega ili jetre preporučuje se početna doza od 10 mg (5 mg dvaput na dan) amifampridina dnevno.
(ng/ml) mean (S.D.), range 
(ng/ml) srednja vrijednost (S.D.), raspon
Mean (SD) p-valuee a 
Rezultati CGI-I-ac Srednja vrijednost (SD) p-vrijednoste a
Non depolarising muscle relaxant acting medicinal products The concomitant use of amifampridine and medicinal products with non-depolarising muscle relaxant effects (e.g. mivacurium, pipercurium) may lead to a decreased effect of both products and should be taken into consideration. 
Lijekovi koji djeluju kao nedepolarizirajući miorelaksansi Istodobna primjena amifampridina i lijekova s učincima nedepolarizirajućih miorelaksansa (primjerice mivakurij, piperkurij) može uzrokovati smanjeni učinak oba lijeka i to treba uzeti u obzir.
Patients with recent use of immunomodulatory therapies (e.g., azathioprine, mycophenolate, cyclosporine), rituximab, intravenous immunoglobulin G, and plasmapheresis were excluded from the study. 
ciklosporin), rituksimab, intravenski imunoglobulin G ili bili podvrgnuti plazmaferezi isključeni su iz ispitivanja.
• Medicines to relax your muscles - (e.g. mivacurium, pipercurium, suxamethonium) 
• lijekove za opuštanje mišića - (primjerice, mivakurij, piperkurij, suksametonij)
For patients with mild liver or kidney problems a starting dose of 10 mg (5 mg twice a day) FIRDAPSE daily is recommended. 
U bolesnika s blagim problemima s bubrezima ili jetrom preporučuje se početna doza od 10 mg lijeka FIRDAPSE dnevno (5 mg dvaput na dan).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine. 
NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 10 mg amifampridina u obliku amifampridinfosfata.
CGI-I Scoresc 
I DOHVATA DJECE
Depolarising muscle relaxant acting medicinal products The concomitant use of amifampridine and medicinal products with depolarising muscle relaxant effects (e.g. suxamethonium) may lead to a decreased effect of both products and should be taken into consideration. 
Lijekovi koji djeluju kao depolarizirajući miorelaksansi Istodobna primjena amifampridina i lijekova s učincima depolarizirajućih miorelaksansa (primjerice suksametonij) može uzrokovati smanjeni učinak oba lijeka i to treba uzeti u obzir.
Table 1 below lists the adverse reactions reported with amifampridine. 
Nuspojave prijavljene s amifampridinom navedene su u Tablici 1 u nastavku:
Mean 3-N-acetyl Amifampridine PK Parameters 
Srednje vrijednosti farmakokinetičkih parametara 3-N-acetil amifampridina
Please see section 5.2 for further information about bioavailability of amifampridine in the fed and fasted state. 
Za dodatne informacije o bioraspoloživosti amifampridina nakon jela i natašte vidjeti dio 5.2.
• A history of fits (convulsions) 
• nekada ste imali napadaje (konvulzije)
• Blurred vision 
• zamagljeni vid
Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine. 
Jedna tableta sadrži 10 mg amifampridina u obliku amifampridinfosfata.
Mean Amifampridine PK Parameters 
Srednje vrijednosti farmakokinetičkih parametara amifampridina
Slow 
Spori
BioMarin International Limited Shanbally, Ringaskiddy, Co. Cork, P43 R298 Ireland 
BioMarin International Limited Shanbally, Ringaskiddy, Co.
Tabulated list of adverse reactions 
Tabelarni prikaz nuspojava
Renal Status 
Status funkcije bubrega
Fasted (N=45) 59.1 (34.4), 16-137 117 (76.6), 22.1-271 0.637 (0.247), 0.25-1.5 2.5 (0.73), 1.23-4.31 
Cmax (ng/ml) 7,65 38,6 Tmax (h) t1/2 (h)
FIRDAPSE should be used with caution in patients with liver or kidney problems. 
U bolesnika s oštećenjem bubrega ili jetre FIRDAPSE treba primijeniti s oprezom.
Amifampridi ne Dose (mg) Subjects (N) Acetylator Phenotype 
Srednja vrijednost farmakokinetičkih parametara amifampridina AUC0-t (ng*hr/ml)
Calcium stearate 
Fenotip acetilatora Brzi
Proposed review period: Materials will be reviewed annually. 
Predloženo razdoblje pregleda: Materijali će se pregledavati jednom godišnje.
What are the symptoms? 
Koji su simptomi?
• if you are seriously overweight (especially if you are a woman) 
• ako ste ozbiljno pretili (posebice ako ste žena)
It is very important that you read and understand the information about this serious reaction. 
Vrlo je važno da je pročitate i razumijete informacije o toj ozbiljnoj reakciji.
Who gets these reactions? 
Tko može zadobiti ovakve reakcije?
See sections 4.4 and 4.8. 
Vidjeti dijelove 4.4 i 4.8.
WARNING! 
UPOZORENJE!
If you do, within hours, your blood pressure could fall dangerously low, which could result in death. 
Ako to učinite, već unutar nekoliko sati krvni tlak Vam može pasti opasno nisko, što može uzrokovati smrt.
The remainder is eliminated in the faeces. 
Ostatak se eliminira fecesom.
Week 4 (n = 166) 
4. tjedan (n = 166)
Swallow the tablets whole, with some water. 
Tabletu progutajte cijelu s malo vode.
When do these reactions happen? 
Kada se javljaju ovakve reakcije?
Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on posology can be made. 
Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1. i 5.2, međutim ne mogu se dati preporuke o doziranju.
• if they have been taking combination therapy for a long time 
• ako su uzimali kombiniranu terapiju kroz duže razdoblje
So it is very important to talk to your doctor about any changes in your health. 
Zato je vrlo važno da svog liječnika obavijestite o svim promjenama svog zdravstvenog stanja.
Date of latest renewal: 17 November 2014 
Datum posljednje obnove odobrenja: 17. studenog 2014.
These reactions have often been transitory. 
Ti su događaji često bili prolazni.
• difficulty in sleeping (insomnia) 
• teškoće pri spavanju (nesanica)
Kivexa is not recommended for use during pregnancy. 
Kivexa se ne preporučuje za primjenu tijekom trudnoće.