natgillin/translations-raw huggingface dataset:
Rash developed as an adverse reaction in 1.2% of total population treated with Zebinix in clinical studies in epileptic patients.
U 1,2% ukupne populacije liječene Zebinixom u kliničkim ispitivanjima u epileptičkih bolesnika kao nuspojava se pojavio osip.
zebinix 50 mg/ml (outer pack only)
zebinix 50 mg/ml (samo vanjsko pakiranje)
Risk related to epilepsy and antiepileptic medicinal products in general
4.6 Plodnost, trudnoća i dojenje Rizici vezani za epilepsiju i antiepileptičke lijekove općenito
Do not use this medicine after the expiry date, which is stated on the blister, bottle and the carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru, boci i kutiji iza „Rok valjanosti“.
• if you have blistering or peeling of the skin and/or mucous membranes, rash, swallowing or breathing problems, swelling of your lips, face, eyelids, throat or tongue.
• imate mjehuriće po koži ili Vam se ljušti koža i/ili sluznice, imate osip, smetnje gutanja ili smetnje disanja, oticanje usana, lica, vjeđa, grla ili jezika.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka,, obratite se svom liječniku ili ljekarniku.
Toxic epidermal necrolysis, StevensJohnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), angioedema, urticaria
Johnsonov sindrom, osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (DRESS) angioedem, urtikarija
How to store Zebinix
Kako čuvati Zebinix
Blood pressure decreased, weight decreased, blood pressure increased, blood sodium decreased, blood chloride decreased, osteocalcin increased, haematocrit decreased, haemoglobin decreased, transaminases increased
smanjeni natrij u krvi, smanjeni kloridi u krvi, povišeni osteokalcin, smanjeni hematokrit, smanjeni hemoglobin,
Forty-one patients (30.6%) in the eslicarbazepine acetate group compared to 40 patients (31.0%) in the placebo group were responders (≥50% reduction of standardised seizure frequency), resulting in a non-significant difference (p=0.9017).
bolesnika (31,0%) u skupini placeba odgovorilo je na liječenje (≥ 50% smanjenja standarizirane učestalosti napadaja), što je rezultiralo ne značajnom razlikom (p=0,9017).
• Feeling low in energy or tired;
• Osjećaj nedostatka energije ili umora;
The adverse reaction profile of eslicarbazepine acetate is generally similar across age goups.
Profil nuspojava eslikarbazepinacetata općenito je bio sličan u svim dobnim skupinama.
Each ml of oral suspension contains 50 mg of eslicarbazepine acetate.
Jedna ml oralne suspenzije sadrži 50 mg eslikarbazepinacetata.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 30 or 60 tablets
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija s 30 ili 60 tableta
The tablets are packaged in blisters in cardboard boxes containing 20 or 60 tablets, and in HDPE bottles with child resistant closure in cardboard boxes containing 60 tablets.
Tablete su pakirane u blistere u kartonskim kutijama, koje sadrže 20 ili 60 tableta i u HDPE boce sa zatvaračem sigurnim za djecu, u kartonskim kutijama koje sadrže 60 tableta.
The tablets are packaged in blisters in cardboard boxes containing 30 or 60 tablets, and in HDPE bottles with child resistant closure in cardboard boxes containing 90 tablets.
Tablete su pakirane u blistere u kartonskim kutijama, koje sadrže 30 ili 60 tableta i u HDPE boce sa zatvaračem sigurnim za djecu, u kartonskim kutijama koje sadrže 90 tableta.
Zebinix 400 mg tablets are white, circular and biconvex.
Zebinix 400 mg tablete su bijele, okrugle i bikonveksne.
Insert the bottle adapter in the bottle neck opening.
3. korak: Umetnite nastavak u otvor grla boce.
Coordination abnormal, memory impairment, amnesia, hypersomnia, sedation, aphasia, dysaesthesia, dystonia, lethargy, parosmia, cerebellar syndrome, convulsion, peripheral neuropathy, nystagmus, speech disorder, dysarthria, burning sensation, paraesthesia, migraine
hipersomnija, sedacija, afazija, disestezija, distonija, letargija, parosmija, cerebelarni sindrom, konvulzije, periferna neuropatija,
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U
Severe cutaneous adverse reactions (SCARS), including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in post-marketing experience with Zebinix treatment (see section 4.4).
Teške kožne nuspojave (SCARS), uključujući Stevens-Johnsonov sindrom (SJS) / toksičnu epidermalnu nekrolizu (TEN) i osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (DRESS) zabilježene su kod liječenja Zebinixom nakon stavljanja lijeka na tržište (vidjeti dio 4.4).
Zebinix is for oral use.
Zebinix se uzima kroz usta.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 20 or 60 tablets
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija sa 20 ili 60 tableta
• Hearing difficulty;
• Poteškoće sa sluhom;
From the 815 randomized patients, 401 patients were treated with eslicarbazepine acetate once-daily [271 patients (67.6%) remained at dose of 800 mg, 70 patients (17.5%) remained at dose of 1,200 mg and 60 patients (15.0%) were treated with 1,600 mg].
Od 815 randomiziranih bolesnika, 401 bolesnik je liječen eslikarbazepinacetatom jednom dnevno [271 bolesnik (67,6%) ostao je pri dozi od 800 mg, 70 bolesnika (17,5%) ostalo je pri dozi od 1200 mg i 60 bolesnika (15,0%) liječeno je dozom od 1600 mg]. U primarnoj analizi djelotvornosti, u kojoj su ispitanici koji su napustili ispitivanje smatrani ispitanicima bez odgovora, 71,1% ispitanika klasificirano je kao „bez napadaja“ u skupini s eslikarbazepinacetatom, a 75,6% u skupini s karbamazepinom s kontroliranim oslobađanjem, tijekom razdoblja evaluacije od 26 tjedana
The most common treatment-emergent adverse reactions reported, in placebo controlled adjunctive therapy studies with adult epileptic patients and in an active controlled monotherapy study comparing eslicarbazepine acetate with carbamazepine controlled release, were dizziness, somnolence, headache, and nausea.
Najčešće prijavljene nuspojave, tijekom placebom kontroliranih ispitivanja dodatne terapije u odraslih bolesnika s epilepsijom, i u aktivno kontroliranom ispitivanju monoterapije u kojem se eslikarbazepinacetat uspoređivao s karbamazepinom s kontroliranim oslobađanjem, bile su omaglica,
• Muscle pain, pain in limbs, muscular weakness;
• Bolovi u mišićima, bol u udovima, slabost u mišićima; • Poremećaj metabolizma kostiju;
Serious and potentially life-threatening skin reactions including Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in post-marketing experience in patients treated with Zebinix.
Ozbiljne i potencijalno po život opasne kožne nuspojave uključujući Stevens-Johnsonov sindrom / toksičnu epidermalnu nekrolizu i osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (DRESS), zabilježene su u bolesnika liječenih Zebinixom nakon stavljanja lijeka na tržište.
Eisai S.r.l.
Eisai B.V.
The prevalence of HLA-B*1502 carrier is about 10% in Han Chinese and Thai populations.
Prevalencija nositelja HLA-B*1502 u populacijama pripadnika kineskog naroda
À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal tel: +351 22 986 61 00 fax: +351 22 986 61 99 e-mail: info@bial.com
Mamede do Coronado - Portugal tel: +351 22 986 61 00 fax: +351 22 986 61 99 e-mail: info@bial.com
Do not use this medicine after the expiry date, which is stated on the bottle and the carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kutiji iza „Rok valjanosti“.
There are some data that suggest HLA-A*3101 is associated with an increased risk of carbamazepine induced cutaneous adverse drug reactions including SJS, TEN, Drug rash with eosinophilia (DRESS), or less severe acute generalized exanthematous pustulosis (AGEP) and maculopapular rash in people of European descent and the Japanese.
Postoje podaci koji upućuju da je HLA-A*3101 udružen s povećanim rizikom za nastanak kožnih nuspojava induciranih karbamazepinom, uključujući SJS, TEN, osip s eozinofilijom izazvan lijekom
HLA-B* 1502 in individuals of Han Chinese and Thai origin has been shown to be strongly associated with the risk of developing the severe cutaneous reactions known as Stevens Johnson syndrome (SJS) when treated with carbamazepine.
Tai snažno je povezan s rizikom od razvoja teške kožne reakcije poznate kao Stevens-Johnsonov sindrom (SJS), kada se oni liječe karbamazepinom.
Eisai B.V. Tél/Tel: + 31 (0) 900 575 3340
Tel: + 31 (0) 900 575 3340
The tablets have ‘ESL 600'engraved on one side and are scored on the other side, with a length of 17.3 mm.
Tablete imaju utisnuto "ESL 600" na jednoj strani i urez na drugoj strani, dužine su 17,3 mm.
In the double-blind period of the phase III study, the least square mean reduction in standardised seizure frequency with eslicarbazepine acetate (-18.1% versus baseline) was different to placebo (8.6% versus baseline) but not statistically significant (p=0.2490).
U dvostruko slijepom razdoblju ispitivanja faze III smanjenje srednje vrijednosti dobivene metodom najmanjih kvadrata za standardiziranu učestalost napadaja za eslikarbazepinacetat (-18,1% u odnosu na početne vrijednosti) razlikovalo se od placeba (-8,6% u odnosu na početne vrijednosti), ali nije bilo statistički značajno (p=0,2490). 41 bolesnik (30,6%) u skupini eslikarbazepinacetata u usporedbi s 40
Do not use this medicine after the expiry date, which is stated on the blister and the carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza „Rok valjanosti“.
Zebinix oral suspension contains methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed) and sulphites which may rarely cause severe hypersensitivity reactions and bronchospasm.
Oralna suspenzija Zebinix sadrži metilparahidroksibenzoat (E218) koji može izazvati alergijske reakcije
Step 1.
K1.
Eslicarbazepine acetate is extensively converted to eslicarbazepine.
Apsorpcija Eslikarbazepinacetat se opsežno pretvara u eslikarbazepin.
• Urticaria (skin rash with itching).
• Koprivnjača (kožni osip praćen svrbežom)
HDPE bottles with polypropylene child resistant closure, placed into cardboard boxes, containing 90 tablets.
HDPE bočice s polipropilenskim zatvaračem sigurnim za djecu, smještene u kartonske kutije koje sadrže 90 tableta.
In patients with pre-existing renal disease leading to hyponatraemia, or in patients concomitantly treated with medicinal products which may themselves lead to hyponatraemia (e.g. diuretics, desmopressin, carbamazepine), serum sodium levels should be examined before and during treatment with eslicarbazepine acetate.
(npr. diuretici, dezmopresin, karbamazepin), serumska razina natrija treba biti ispitana prije i tijekom liječenja eslikarbazepinacetatom.
HDPE bottles with polypropylene child resistant closure, inside a cardboard box, containing 60 tablets.
HDPE boce s polipropilenskim zatvaračem sigurnim za djecu, u kartonskim kutijama koje sadrže 60 tableta.
Forty-two patients (50.6%) in the eslicarbazepine acetate group compared to 10 patients (25.0%) in the placebo group were responders (≥50% reduction of standardised seizure frequency), resulting in a significant difference (p=0.009).
42 bolesnika (50,6%) u skupini eslikarbazepinacetata u usporedbi s 10 bolesnika (25,0%) u skupini placeba imalo je odgovor na liječenje
White oblong tablets, engraved ‘ESL 600'on one side and scored on the other side, with a length of 17.3 mm.
Bijele duguljaste tablete s utisnutim "ESL 600" na jednoj strani i urezom na drugoj strani, dužine 17,3 mm.
The tablets have ‘ESL 800'engraved on one side and are scored on the other side, with a length of 19 mm.
Tablete imaju utisnuto "ESL 800" na jednoj strani i urez na drugoj strani, dužine su 19 mm.
• Thermal burn;
• Toplinske opekline;
Contact a doctor or go to a hospital immediately if you experience any of the above symptoms.
Ako iskusite neki od gore navedenih simptoma odmah se obratite liječniku ili otiđite u hitni odjel bolnice.
Adult population
Doziranje Odrasli
EU/1/09/514/001 7 tablets - ALU/ALU blister EU/1/09/514/002 14 tablets - ALU/ALU blister EU/1/09/514/003 28 tablets - ALU/ALU blister EU/1/09/514/004 7 tablets - PVC/ALU blister EU/1/09/514/005 14 tablets - PVC/ALU blister EU/1/09/514/006 28 tablets - PVC/ALU blister
- Al/Al blister EU/1/09/514/003 28 tableta - Al/Al blister EU/1/09/514/004 7 tableta - PVC/Al blister EU/1/09/514/005 14 tableta - PVC/Al blister EU/1/09/514/006 28 tableta - PVC/Al blister
White oblong tablets, engraved 'ESL 200' on one side and scored on the other side, with a length of 11 mm.
Bijele duguljaste tablete s utisnutim "ESL 200" na jednoj strani i urezom na drugoj strani, dužine 11 mm.
2 What you need to know before you take Zebinix Do not take Zebinix:
Što je Zebinix i za što se koristi Što morate znati prije nego počnete uzimati Zebinix Kako uzimati Zebinix
Administration of eslicarbazepine acetate 1,200 mg once daily to female subjects using a combined oral contraceptive showed an average decrease of 37% and 42% in systemic exposure to levonorgestrel and ethinylestradiol, respectively, most likely caused by an induction of CYP3A4.
Primjena eslikarbazepinacetata 1200 mg jednom dnevno kod ženskih ispitanica koje koriste kombinirane oralne kontraceptive, pokazala je prosječno smanjenje od 37% u sistemskoj izloženosti levonorgestrelu i
Croscarmellose sodium Magnesium stearate
Toksična epidermalna nekroliza, Stevens
• Swelling in your legs and arms;
• Otekline nogu ili ruku;
• Severe pain in the back and stomach (caused by inflamation of the pancreas);
• Smanjenje broja krvnih pločica što povećava opasnost od krvarenja ili stvaranja modrica; • Jaki bolovi u leđima i trbuhu (uzrokovani upalom gušterače);
Eslicarbazepine acetate
poremećaji hoda, astenija
Nausea, vomiting, diarrhoea
diazepama, digoksina, fenitoina i tolbutamida.
• Abnormal sense of touch;
• Poremećaj osjeta dodira;
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing eslicarbazepine acetate were warranted.
smatra da su promjene u informacijama o lijeku lijekova koji sadrže eslikarbazepinacetat opravdane.
White circular biconvex tablets, engraved ‘ESL 400'on one side and scored on the other side, with a diameter of 11 mm..
Bijele okrugle bikonveksne tablete s utisnutim "ESL 400" na jednoj strani i urezom na drugoj strani, promjera 11 mm.
zebinix 200 mg (outer pack only)
zebinix 200 mg (samo vanjsko pakiranje)
• Seizures;
• Napadaji;
White oblong tablets, engraved ‘ESL 800'on one side and scored on the other side, with a length of 19 mm.
Bijele duguljaste tablete s utisnutim "ESL 800" na jednoj strani i urezom na drugoj strani, dužine 19 mm.
In the newborn child
Novorođenčad
Eslicarbazepine acetate was tested at doses of 1,200 mg and 1,600 mg once-daily.
Eslikarbazepinacetat ispitivan je u dozama od 1200 mg i 1600 mg jednom dnevno.
zebinix 800 mg (outer pack only)
zebinix 800 mg (samo vanjsko pakiranje)
In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 1,200 mg once daily and phenytoin resulted in an average decrease of 31-33% in exposure to the active metabolite, eslicarbazepine, most likely caused by an induction of glucuronidation, and an average increase of 31-35% in exposure to phenytoin, most likely caused by an inhibition of CYP2C19.
U ispitivanju u zdravih ispitanika, istodobna primjena eslikarbazepinacetata 1200 mg jednom dnevno i fenitoina rezultirala je u prosjeku padom od 31-33% u izloženosti aktivnom metabolitu eslikarbazepinu,
The tablets have ‘ESL 200'engraved on one side and are scored on the other side, with a length of 11 mm.
Tablete imaju utisnuto "ESL 200" na jednoj strani i urez na drugoj strani, dužine su 11 mm.
Flavour Tutti-Frutti artificial (contains maltodextrin, propylene glycol, natural and artificial flavouring, and gum acacia (E414)
saharinnatrij (E954), umjetna aroma tutti-frutti (sadrži maltodekstrin, propilenglikol, prirodne i umjetne arome i arapsku gumu (E414), maskirajuću aromu (sadrži propilenglikol, vodu i prirodne i umjetne arome) i pročišćena voda.
The tablets have ‘ESL 400'engraved on one side and are scored on the other side, with a diameter of 11 mm.
Tablete imaju utisnuto "ESL 400" na jednoj strani i urez na drugoj strani, promjera su 11 mm.
zebinix 600 mg (outer pack only)
zebinix 600 mg (samo vanjsko pakiranje)
• Sedation;
• Sedacija;
Zebinix 200 mg tablets
Zebinix 200 mg tablete
Zebinix 800 mg tablets
Zebinix 800 mg tablete
Zebinix 800 mg tablets are white and oblong.
Zebinix 800 mg tablete su bijele i duguljaste.
Zebinix 400 mg tablets
Zebinix 400 mg tablete
Each tablet contains 200 mg of eslicarbazepine acetate.
Jedna tableta sadrži 200 mg eslikarbazepinacetata.
Zebinix 600 mg tablets
Zebinix 600 mg tablete
• if you have kidney problems.
• imate problema sa bubrezima.
Severe cutaneous adverse reactions (SCARS) including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported in post-marketing experience with Zebinix treatment.
severe cutaneous adverse reactions, SCARS) uključujući Stevens-Johnsonov sindrom (SJS) / toksičnu epidermalnu nekrolizu (TEN) i kožni osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (engl. drug reaction with eosinophilia and systemic symptoms, DRESS), koji mogu biti opasni po život ili imati smrtni ishod.
Eslicarbazepine acetate was tested at once-daily doses of 800 mg, 1,200 mg and 1,600 mg.
Eslikarbazepinacetat ispitivan je u dozama od 800 mg, 1200 mg i 1600 mg primjenjivanim jednom dnevno.
Zebinix 800 mg tablets Eslicarbazepine acetate
Zebinix 800 mg tablete eslikarbazepinacetat
Zebinix 200 mg tablets are white and oblong.
Zebinix 200 mg tablete su bijele i duguljaste.
Each tablet contains 400 mg of eslicarbazepine acetate.
Jedna tableta sadrži 400 mg eslikarbazepinacetata.
• Headache;
• Padovi;
Each tablet contains 800 mg of eslicarbazepine acetate.
Jedna tableta sadrži 800 mg eslikarbazepinacetata.
Contains methyl parahydroxybenzoate (E218) and sulphites See leaflet for further information
Sadrži metilparahidroksibenzoat (E218) i sulfite.
• Medicine toxicity; • Anxiety.
psihomotorna retardacija; anksioznost
Zebinix 200 mg tablets Eslicarbazepine acetate
Zebinix 200 mg tablete eslikarbazepinacetat
• Diarrhoea;
• Migrena;
Package leaflet: Information for the user Zebinix 200 mg tablets
Uputa o lijeku: Informacije za korisnika Zebinix 200 mg tabletе eslikarbazepinacetat
Each tablet contains 600 mg of eslicarbazepine acetate.
Jedna tableta sadrži 600 mg eslikarbazepinacetata.
Package leaflet: Information for the user Zebinix 800 mg tablets
Uputa o lijeku: Informacije za korisnika Zebinix 800 mg tabletе eslikarbazepinacetat
Zebinix 600 mg tablets are white and oblong.
Zebinix 600 mg tablete su bijele i duguljaste.
• Feeling generally weak, unwell or having chills;
• Infekcija mokraćnih putova; • Osjećaj opće slabosti, loše osjećanje ili zimica;
Zebinix 400 mg tablets Eslicarbazepine acetate
Zebinix 400 mg tablete eslikarbazepinacetat
• Bone metabolism disorder;
Mijalgija, poremećaj metabolizma kostiju,
Zebinix 600 mg tablets Eslicarbazepine acetate
Zebinix 600 mg tablete eslikarbazepinacetat
In the age group from 6 to 11 years of age, the most common adverse reactions observed in more than two patients treated with eslicarbazepine acetate were diplopia (9.5%), somnolence (7.4%), diziness (6.3%), convulsion (6.3%) and nausea (3.2%); in the age group from 12 to 18 years were somnolence (7.4%), vomiting (4.2%), diplopia (3.2%) and fatigue (3.2%).
U dobnoj skupini od 6 do 11 godina najčešće nuspojave primijećene u više od dva bolesnika liječena eslikarbazepinacetatom bile su diplopija (9,5%), somnolencija (7,4%), omaglica (6,3%), konvulzije
Remove the bottle, the oral syringe and the bottle adapter from the box Step 2.
1. korak: Izvadite iz kutije bocu, štrcaljku za usta i nastavak
Package leaflet: Information for the user Zebinix 400 mg tablets
Uputa o lijeku: Informacije za korisnika Zebinix 400 mg tabletе eslikarbazepinacetat
EU/1/09/514/007 30 tablets - ALU/ALU blister EU/1/09/514/008 60 tablets - ALU/ALU blister EU/1/09/514/009 30 tablets - PVC/ALU blister EU/1/09/514/010 60 tablets - PVC/ALU blister
- Al/Al blister EU/1/09/514/009 30 tableta - PVC/Al blister EU/1/09/514/010 60 tableta - PVC/Al blister
Package leaflet: Information for the user Zebinix 600 mg tablets
Uputa o lijeku: Informacije za korisnika Zebinix 600 mg tabletе eslikarbazepinacetat
• Itching;
• Drhtavica;
The oral suspension is packaged in amber glass bottles with HDPE child resistant closures containing 200 ml oral suspension, inside a cardboard box.
Oralna suspenzija je pakirana u bocama od smeđeg stakla s HDPE zatvaračem sigurnim za djecu i sadrže
Epistaxis, chest pain
Epistaksa, bol u prsištu
(increase of ≥25%) compared to Baseline Parts III-V was 25.7%.
(9,2 %) je liječeno ESL-om do kraja otvorenog dijela V.
• Shaking;
• Proljev;
The National Competent Authorities of Member States or Reference Member States if applicable, shall ensure that the following condition is fulfilled by the MAH(s):
Nacionalna nadležna tijela država članica ili referentnih država članica, ako je primjenljivo, osiguravaju da nositelj(i) odobrenja ispune sljedeći uvjet:
Suspension of the marketing authorisations should be lifted when bioequivalence to an EU Reference Medicinal Product has been established based on a bioequivalence study conducted visà-vis the EU Reference Medicinal Product.
Privremeno oduzimanje odobrenja za stavljanje u promet lijeka treba se ukinuti nakon što je utvrđena bioekvivalencija s referentnim lijekom odobrenim unutar EU-a na temelju ispitivanja bioekvivalencije u odnosu na referentni lijek odobren unutar EU-a.
Conditions for lifting the suspension of the Marketing Authorisations
Uvjeti za ukidanje privremenog oduzimanja odobrenja za stavljanje lijeka u promet
Annex III Condition for lifting the suspension of the Marketing Authorisations
Uvjet za ukidanje privremenog oduzimanja odobrenja za stavljanje lijeka u promet
The recommended dose is 10 mg per kilogram bodyweight.
Preporučena je doza 10 mg po kilogramu tjelesne težine.
The full EPAR for Zinplava can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Zinplava nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Zinplava bezlotoxumab
Zinplava bezlotoksumab
It is given as a single infusion lasting around 1 hour.
Lijek se daje jednokratnom infuzijom u trajanju od približno sat vremena.
What is Zinplava and what is it used for?
Što je Zinplava i za što se koristi?
A new episode of diarrhoea was defined as 3 or more loose stools in 24 or fewer hours.
Nova epizoda proljeva definirana je kao tri ili više mekanih stolica u 24 sata ili u kraćem razdoblju.
What measures are being taken to ensure the safe and effective use of Zinplava?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zinplava?
This is a summary of the European public assessment report (EPAR) for Zinplava.
Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Zinplava.
The most common side effects with Zinplava (seen in more than 4 in 100 patients) are nausea (feeling sick), diarrhoea, fever and headache.
Najčešće nuspojave lijeka Zinplava (zabilježene u više od 4 na 100 bolesnika) jesu mučnina, proljev, vrućica i glavobolja.
What are the risks associated with Zinplava?
Koji su rizici povezani s lijekom Zinplava?
After an initial infection, some dormant forms of the bacteria (spores) may persist in the body and eventually produce further toxins, causing the symptoms to return.
Nakon prvotne infekcije neki oblici bakterija u mirovanju (spore) mogu se zadržati u tijelu i s vremenom opet proizvoditi toksine te tako prouzročiti povratak simptoma.