FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Faslodex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Faslodex pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: As a result, the cancer cells are not stimulated to grow by oestrogen and this slows down the growth of the tumour.
Croatian: Kao rezultat toga, estrogen ne potiče rast stanica raka te se usporava rast tumora.
English: • postmenopausal women with a type of breast cancer known as ‘oestrogen-receptor positive cancer' who have not previously had hormonal treatment, or whose cancer had come back after treatment with another anti-oestrogen;
Croatian: • u žena u postmenopauzi s vrstom raka dojke poznatim pod nazivom „rak dojke pozitivan na estrogenski receptor” koje prethodno nisu primile nikakvu hormonsku terapiju ili kojima se rak ponovno javio nakon liječenja drugim anti-estrogenom;
English: What are the risks associated with Faslodex?
Croatian: Koji su rizici povezani s lijekom Faslodex?
English: Faslodex can only be obtained with a prescription.
Croatian: Lijek Faslodex izdaje se samo na liječnički recept.
English: Why is Faslodex approved?
Croatian: Zašto je lijek Faslodex odobren?
English: The fourth study, in 462 women with advanced or metastatic breast cancer who had not been treated with hormonal therapy, showed that women treated with Faslodex (500 mg once a month) lived for an average of 16.6 months without their disease getting worse, compared with 13.8 months for women given anastrozole.
Croatian: Četvrto ispitivanje, u kojemu su sudjelovale 462 žene s uznapredovalim ili metastatskim rakom dojke koje nisu liječene hormonskom terapijom, pokazalo je da su žene liječene lijekom Faslodex (500 mg jedanput mjesečno) živjele u prosjeku 16,6 mjeseci bez pogoršanja bolesti, u usporedbi s 13,8 mjeseci u slučaju žena koje su primale anastrozol.
English: For practical information about using Faslodex, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Faslodex bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: When Faslodex is used on its own, the most common side effects (seen in more than 1 patient in 10) are injection-site reactions (such as pain or inflammation), weakness, nausea (feeling sick) and increased liver enzyme levels in the blood (a sign of liver problems).
Croatian: Pri primjeni lijeka Faslodex u monoterapiji najčešće su nuspojave (zabilježene u više od 1 na 10 bolesnica) reakcije na mjestu primjene injekcije (kao što su bol ili upala), slabost, mučnina (osjećaj slabosti) i povišene razine jetrenih enzima u krvi (znak problema s jetrom).
English: Finally, a study investigating the use of Faslodex in combination with palbociclib in 521 women with (HR)-positive (HER2)-negative advanced or metastatic breast cancer showed that women treated with Faslodex plus palbociclib lived for an average of 9.2 months without their disease getting worse, compared with 3.8 months for women given Faslodex on its own.
Croatian: Naposljetku, ispitivanje u kojemu je istraživana primjena lijeka Faslodex u kombinaciji s palbociklibom, u kojemu je sudjelovala 521 žena s HR-pozitivnim i HER2-negativnim uznapredovalim ili metastatskim rakom dojke, pokazalo je da su žene liječene lijekom Faslodex i palbociklibom živjele u prosjeku 9,2 mjeseca bez pogoršanja bolesti, u usporedbi s 3,8 mjeseci u slučaju žena koje su primale lijek Faslodex kao monoterapiju.
English: What benefits of Faslodex have been shown in studies?
Croatian: Koje su koristi lijeka Faslodex dokazane u ispitivanjima?
English: When used in combination with palbociclib, the most common side effects with Faslodex (seen in more than 2 patients in 10) are low levels of white and red blood cells, low blood platelet counts, infections, tiredness, nausea, stomatitis (inflammation of the lining of the mouth) and diarrhoea.
Croatian: Pri primjeni lijeka Faslodex u kombinaciji s palbociklibom najčešće su nuspojave (zabilježene u više od 2 na 10 bolesnica) niske razine bijelih i crvenih krvnih stanica, nizak broj krvnih pločica, infekcije, umor, mučnina, stomatitis (upala sluznice usne šupljine) i proljev.
English: Faslodex contains the active substance fulvestrant.
Croatian: Faslodex sadržava djelatnu tvar fulvestrant.
English: Studies showed that Faslodex, an anti-oestrogen medicine, is effective at prolonging the time patients with oestrogen-receptor positive breast cancer can live without their disease getting worse.
Croatian: Ispitivanja su pokazala da lijek Faslodex, anti-estrogen, učinkovito djeluje na produljenje životnog vijeka bez pogoršanja bolesti u bolesnica s rakom dojke pozitivnim na receptor estrogena.
English: How does Faslodex work?
Croatian: Kako djeluje Faslodex?
English: For the full list of all side effects and restrictions with Faslodex, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Faslodex potražite u uputi o lijeku.
English: How is Faslodex used?
Croatian: Kako se Faslodex koristi?
English: Most types of breast cancer are stimulated to grow when the hormone oestrogen attaches to targets (receptors) on cancer cells.
Croatian: Vezivanje hormona estrogena na ciljeve (receptori) stanica raka potiče rast većine vrsta raka dojke.
English: Five main studies showed that Faslodex is effective at prolonging the length of time patients live without their disease getting worse.
Croatian: Djelotvornost lijeka Faslodex u produljenju životnog vijeka bolesnica bez pogoršanja bolesti dokazana je u pet glavnih ispitivanja.
English: A third study in 736 women showed that the higher dose of 500 mg of Faslodex was more effective than 250 mg: women receiving the higher dose lived for an average of 6.5 months without their disease getting worse, compared with 5.5 months in those receiving the lower dose.
Croatian: Treće ispitivanje, u kojemu je sudjelovalo 736 žena, pokazalo je da je viša doza lijeka Faslodex od 500 mg učinkovitija od doze od 250 mg.
English: Two of these studies in 851 women showed that Faslodex was as effective as another medicine, anastrozole: women receiving Faslodex lived for an average of 5.4 months without their disease getting worse, compared with 4.1 months for those taking anastrozole.
Croatian: Žene koje su primale Faslodex živjele su u prosjeku 5,4 mjeseca bez pogoršanja bolesti, u usporedbi s 4,1 mjesec u slučaju žena koje su primale anastrozol.
English: Ichthyol-Gesellschaft Cordes, Hermanni & Co. (Gmbh & Co.) Kg
Croatian: Ichthyol-Gesellschaft Cordes, Hermanni & Co. (Gmbh & Co.)
English: Teva Magyarország Zrt
Croatian: Teva Magyarország Zrt Isotretinoin Teva
English: Tretinoina Same Savoma Medicinali
Croatian: Savoma Medicinali Spa Tretinoina Same Savoma Medicinali
English: Arrow Generiques Acnetrait
Croatian: Arrow Generiques
English: Genus Pharmaceuticals
Croatian: Acitretin Genus Pharmaceuticals
English: Roche (Magyarország) Kft Roaccutan
Croatian: Roche (Magyarország) Kft
English: Isotretinoin 500µg G Gel
Croatian: Isotretinoin 500 µg/g
English: Ennogen Healthcare Limited
Croatian: Ujedinjeno Kraljevstvo Ennogen Healthcare Limited
English: Laboratorios Galderma SaSucursal Em Portugal
Croatian: Laboratorios Galderma Sa - Sucursal Em Portugal
English: United Kingdom Sandoz Ltd
Croatian: Ujedinjeno Kraljevstvo Sandoz Ltd
English: Galderma (Uk) Limited
Croatian: Galderma (Uk) Limited Differin
English: Mg
Croatian: Kg
English: Laboratoires Bailleul Sa
Croatian: Laboratoires Bailleul Sa Erylik
English: Roche Slovensko S.R.O.
Croatian: Slovačka Republika Roche Slovensko S.R.O.
English: Pharmaceuticals Polska Sp. Z O.O.
Croatian: Teva Pharmaceuticals Polska Sp. Z O.O.
English: Meda Pharma Spol.
Croatian: Slovačka Republika Meda Pharma Spol.
English: Adapalene 0.1%w/W Cream
Croatian: Adapalen 0,1% w/w
English: Societe D'etudes Et De Recherches Pharmaceutiques (Serp)
Croatian: Societe D'etudes Et De Recherches
English: Isotretinoin Generics [uk]
Croatian: Generics [uk] Limited Isotretinoin Generics [uk]
English: United Kingdom Roche Products Ltd Roaccutane
Croatian: Ujedinjeno Kraljevstvo Roche Products Ltd Roaccutane
English: Adapalene 0.1% Gel
Croatian: Adapalen 0,1%
English: Glaxosmithkline Gmbh & Co. Kg
Croatian: Glaxosmithkline Gmbh & Co.
English: Almirall Hermal Gmbh
Croatian: Almirall Hermal Gmbh Aknenormin
English: Dermapharm Ag Keraderm
Croatian: Dermapharm Ag
English: Louis Widmer Gmbh De
Croatian: Louis Widmer Gmbh De Wicaran
English: Isotretinoin Ranbaxy (Uk)
Croatian: Ujedinjeno Kraljevstvo Ranbaxy (Uk) Limited Isotretinoin Ranbaxy (Uk)
English: Dexpanthenol 0.1mg G, Tretinoin 3µg G, Urea 1.2mg G
Croatian: Dekspantenol 0,1 mg/g, tretinoin 3 µg/g, ureja 1,2 mg/g
English: Meda Pharma
Croatian: Meda Pharma Sas
English: Glaxosmithkline Slovakia S.R.O.
Croatian: Slovačka Republika Glaxosmithkline Slovakia S.R.O.
English: Glaxosmithkline Aebe
Croatian: Glaxosmithkline Aebe Cehado
English: Puren Pharma Gmbh & Co. Kg
Croatian: Puren Pharma Gmbh & Co.
English: Galderma International
Croatian: Galderma International Differine
English: Isotretinoin 0.05%w/W Gel
Croatian: Izotretinoin 0,05% w/w Gel
English: Roche Latvija Sia Roaccutane
Croatian: Roche Latvija Sia
English: Isotretinoin Ratiopharm Isotretinoin 20mg
Croatian: Ratiopharm Gmbh Isotretinoin Ratiopharm Izotretinoin 20 mg
English: Laboratório Medinfar - Produtos Farmacêuticos, S.A.
Croatian: Laboratório MedinfarProdutos Farmacêuticos, S.A.
English: Pharmaswiss česká Republika S.R.O.
Croatian: Pharmaswiss česká
English: Erythromycin 4g/100 G, Tretinoin 0.025g/100 G Gel
Croatian: Eritromicin 4 g/100 g, tretinoin 0,025 g/100 g
English: Pharmaceuticals Ireland
Croatian: Ujedinjeno Kraljevstvo Allergan Pharmaceuticals Ireland
English: Ziaja Ltd Zakład Produkcji Leków Sp Z O.O.
Croatian: Produkcji Leków Sp Z O.O.
English: Acitretin 25mg Capsule Capsule
Croatian: Acitretin 25 mg kapsula
English: Galderma Laboratorium Gmbh Differin
Croatian: Galderma Laboratorium Gmbh
English: Actavis Group Ptc Acnenor
Croatian: Actavis Group Ptc Ehf. неотигазон
English: Acitretin 10mg Capsule Capsule
Croatian: Acitretin 10 mg kapsula
English: Sapiens Pharmaceuticals Ltd Rotren
Croatian: Sapiens Pharmaceuticals Ltd
English: Tretinoin 500µg/Ml, DlAlpha Tocopherol Acetate 100µg/Ml
Croatian: Atrederm 0,05% Tretinoin 500 µg/ml, DL-alfa tokoferol acetat 100 µg/ml
English: Galderma Hellas S.A. Epiduo
Croatian: Galderma Hellas S.A.
English: Farmacêuticos, S.A. Acnatac
Croatian: Laboratorios Viñas, S.A. Acnemin
English: Tretinoin 15mg/30 G Cream
Croatian: Tretinoin 15 mg/30 g
English: Tazarotene 0.1mg/100 Gel
Croatian: Tazaroten 0,1 mg/100 mg Gel
English: Tretinoin 250µg/Ml, DlAlpha Tocopherol Acetate 50µg/Ml
Croatian: Atrederm 0.025% Tretinoin 250 µg/ml, DL-alfa tokoferol acetat 50 µg/ml
English: Nexus Medicals S.A. Accuran
Croatian: Nexus Medicals S.A.
English: Glaxosmithkline (Cyprus) Limited Isotrexin
Croatian: Glaxosmithkline (Cyprus) Limited
English: Isotretinoin 20mg
Croatian: Izotretinoin 20 mg/g
English: Adapalene 1mg G
Croatian: Adapalen 1 mg/g
English: Tretinoin 10mg Capsule Capsule, Soft
Croatian: Tretinoin 10 mg kapsula Kapsula, meka
English: Adapalene 1mg G, Benzoyl Peroxide 25mg G
Croatian: Adapalen 1mg/g, benzoilperoksid 25 mg/g
English: Atrederm 0,05%
Croatian: Tretinoin 0,05%
English: Pierre Fabre Italia S.P.A.
Croatian: Pierre Fabre Italia S.P.A. Zorac
English: Tretinoin 0.3mg G, Urea 120mg G
Croatian: Tretinoin 0,3 mg/g, ureja 120 mg/g
English: Hydrocortisone 10mg G, Tretinoin 1mg G,
Croatian: Hidrokortizon 10 mg/g, tretinoin 1 mg/g, hidrokinon 50 mg/g
English: Alliance Pharmaceuticals Ltd
Croatian: Ujedinjeno Kraljevstvo Alliance Pharmaceuticals Ltd
English: Pharmathen Hellas S.A.
Croatian: Pharmathen Hellas S.A. A-Cnotren
English: Isotretinoin Puren
Croatian: Isotretinoina Stiefel
English: Isotretinoin
Croatian: Isotretinoína
English: Clindamycin Phosphate 10mg G, Tretinoin 0.25mg G
Croatian: Klindamicin fosfat 10 mg/g, tretinoin 0,25 mg/g
English: Meda Pharmaceuticals Ltd Atralin
Croatian: Meda Pharmaceuticals Ltd
English: Tretinoin 0.025g/100 G Cream
Croatian: Tretinoin 0,025 g/100 g Krema
English: Glaxosmithkline (Ireland) Limited Isotrexin
Croatian: Glaxosmithkline (Ireland) Limited
English: Tazarotene 0.05g/100 G Gel
Croatian: Tazaroten 0,05 g/100 g Gel
English: Isotretinoin Jenson Isotretinoin 5mg Capsule Capsule, Soft
Croatian: Generics [uk] Limited Isotretinoin Jenson Izotretinoin 5 mg kapsula Kapsula, meka
English: Erythromycin 20mg G, Isotretinoin 0.5mg G Gel
Croatian: Eritromicin 20 mg/g, izotretinoin 0,5 mg/g
English: Carbamid + Vas Creme
Croatian: Ureotop + Vas
English: Pharmaceuticals Limited
Croatian: Ujedinjeno Kraljevstvo Genus Pharmaceuticals Limited
English: Topical Application
Croatian: Topikalna primjena
English: Isotretinoin Teva
Croatian: Adapalene Teva
English: Adapalène Zentiva Adapalene 0.1g/100 G Gel
Croatian: Sanofi-Aventis France Adapalène Zentiva Adapalen 0,1 g/100 g
English: Isotretinoin 0.05g/100 G Gel
Croatian: Izotretinoin 0,05 g/100 g Gel
English: Acitretin Genus Pharmaceuticals Acitretin 25mg Capsule Capsule, Hard
Croatian: Acitretine Aurobindo Acitretin 25 mg komad Kapsula, tvrda
English: Isotretinoin 10mg
Croatian: Izotretinoin 10 mg/g
English: Acitretin 25mg Tablet
Croatian: Acitretin 25mg kapsula
English: Tazarotene 1mg G Gel
Croatian: Tazaroten 1 mg/g
English: Isotretinoin 0.5mg G
Croatian: Izotretinoin 0.5mg/g
English: Meda Pharma Sia Treclinac
Croatian: Meda Pharma Sia
English: Clindamycin 10mg G, Tretinoin 0.025mg G Gel
Croatian: Klindamicin 10 mg/g, tretinoin 0,025 mg/g
English: Erythromycin 20mg G, Isotretinoin 0.05mg G Gel
Croatian: Eritromicin 20 mg/g, izotretinoin 0,05 mg/g
English: Isotretinoin 0.5mg
Croatian: Izotretinoin 0,5 mg
English: Adapalene Zentiva Adapalene 0.1% Cream
Croatian: Sanofi-Aventis France Adapalene Zentiva Adapalen 0,1%
English: Tretinoin 0.5mg/Mg Cream
Croatian: Tretinoin 0,5mg/mg
English: Tretinoin 0.25mg/Mg Cream
Croatian: Tretinoin 0,25 mg/mg
English: Laboratoires Smb S.A.
Croatian: Laboratoires Smb S.A. Isosupra Lidose
English: Clindamycin 10mg G, Tretinoin 0.25mg G Gel
Croatian: Klindamicin 10 mg/g, tretinoin 0,25 mg/g
English: Adapalene Teva Adapalene 0.1g G
Croatian: Adapalen 0,1 g/g
English: Isosupra Lidose Isotretinoin 8mg Capsule Capsule, Hard
Croatian: Isotretinoína Aurovitas Izotretinoin 10 mg kapsula Kapsula, meka
English: Tretinoin 0.05g/100 G Cream
Croatian: Tretinoin 0,05g/100 g
English: Adapalene 0.1g/100 G Gel
Croatian: Adapalen 0,1 g/100 g
English: Aebe
Croatian: Zanea
English: Tazarotene 0.1g/100 G Gel
Croatian: Tazaroten 0,1 g/100 g
English: Acitretin Genus Pharmaceuticals Acitretin 10mg Capsule Capsule, Hard
Croatian: Acitretine Aurobindo Acitretin 10 mg komad Kapsula, tvrda
English: Regiomedica Gmbh Regioderm Acitretin 10mg Capsule Capsule, Hard
Croatian: Ratiopharm Gmbh Isotretinoin Ratiopharm Izotretinoin 10 mg kapsula Kapsula, meka
English: Isotretinoin Alliance Pharmaceuticals Isotretinoin 5mg Capsule Capsule, Soft
Croatian: Pharmachemie B.V Isotretinoïne Pch Izotretinoin 10 mg kapsula Kapsula
English: Adapalene 0.1g/100 G Cream
Croatian: Tazaroten 0,05 g/100 g Krema
English: Panretin
Croatian: Atralin
English: Stiefel Laboratories Toctino
Croatian: Laboratoires Bailleul Sa Contracne
English: A-Cnotren
Croatian: Neotigason
English: Tazarotene 0.5mg G Gel
Croatian: Tazaroten 0,5 mg/g
English: Isotretinoin 5mg Capsule Capsule, Soft
Croatian: Izotretinoin 8 mg kapsula Kapsula, tvrda
English: Meda Pharmaceuticals S.A. Acnatac
Croatian: Meda Pharmaceuticals S.A.
English: It is available as capsules and sachets (250 and 500 mg).
Croatian: Dostupan je kao kapsule i vrećice (250 i 500 mg).
English: The main measure of effectiveness was the number of patients who ‘responded' to treatment.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika koji su „odgovorili” na liječenje.
English: This type of epilepsy first appears in young children during the first year of life.
Croatian: Ovaj se tip epilepsije prvo pojavljuje u mlađe djece tijekom prve godine života.
English: The dose of valproate does not normally need to be adjusted.
Croatian: Doza valproata se normalno ne mora prilagođavati.
English: GABA is the main substance in nerve cells responsible for reducing the electrical activity of the brain.
Croatian: GABA je glavna tvar u živčanim stanicama odgovorna za smanjenje električne aktivnosti mozga.
English: This summary was last updated in 06-2014.
Croatian: Sažetak je posljednji put ažuriran 06.2014.
English: EPAR summary for the public stiripentol
Croatian: EPAR, sažetak za javnost stiripentol
English: The recommended dose is 50 mg per kilogram bodyweight, divided into two or three doses during the day.
Croatian: Preporučena doza iznosi 50 mg po kilogramu tjelesne težine, podijeljeno u dvije ili tri doze tijekom dana.
English: This was switched to a full marketing authorisation on 8 January 2014.
Croatian: Ovo je odobrenje promijenjeno u potpuno odobrenje za stavljanje lijeka u promet 8. siječnja 2014.
English: Diacomit was originally given ‘conditional approval' because there was more evidence to come about the medicine, in particular regarding its short-term and long-term effectiveness and safety.
Croatian: Za lijek Diacomit izdano je „uvjetno odobrenje” jer je bilo potrebno dostaviti dodatni dokazi o lijeku, a posebice o kratkoročnoj i dugoročnoj djelotvornosti i sigurnosti.
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Croatian: Budući da je tvrtka dostavila dodatne potrebne informacije, odobrenje za stavljanje lijeka u promet promijenjeno je iz uvjetnog odobrenja i potpuno odobrenje.
English: Other information about Diacomit
Croatian: Ostale informacije o lijeku Diacomit
English: It has been shown in experimental models to increase the levels of a ‘neurotransmitter' called gamma aminobutyric acid (GABA) in the brain.
Croatian: Na eksperimentalnim modelima pokazalo se povećava razinu „neurotransmitera” naziva gama-aminobutirijska kiselina (GABA) u mozgu.
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Diacomit on 4 January 2007.
Croatian: Europska komisija izdala je uvjetno odobrenje za stavljanje u promet koje za lijek Diacomit vrijedi na prostoru Europske unije od 4. siječnja 2007.
English: After starting Diacomit, the dose of clobazam may need to be reduced.
Croatian: Nakon početka liječenja lijekom Diacomit, doza klobazama će se možda morati smanjiti.
English: Treatment starts with a dose of 20 mg per kg bodyweight, which is gradually increased to the recommended dose over a number of weeks depending on the patient's age.
Croatian: Liječenje započinje s dozom od 20mg po kilogramu tjelesne težine, koja se postepeno povećava do preporučene doze tijekom razdoblja od nekoliko tjedana ovisno o dobi bolesnika.
English: Diacomit has been studied in two main studies involving 65 children between three and 18 years of age.
Croatian: Diacomit se ispitivao u dva glavna ispitivanja koja su obuhvatila 65 djece u dobi od tri do 18 godina.
English: Diacomit should be given at the same time as food, but not with dairy products, carbonated drinks, fruit juice, or food or drinks that contain caffeine or theophylline (a substance found in black and green tea, among other products).
Croatian: Diacomit se treba davati istovremeno s hranom, no ne smije se davati s mliječnim proizvodima, gaziranim pićima, voćnim sokovima ili hranom ili pićima koja sadrži kofein ili teofilin (tvar koja je prisutna u crnom i zelenom čaju, kao i u drugim proizvodima).
English: More patients responded to treatment with Diacomit than to placebo.
Croatian: Više je bolesnika odgovorilo na liječenje lijekom Diacomit nego placebom.
English: The CHMP concluded that Diacomit had shown its effectiveness in SMEI, albeit studies were limited and did not last as long as the Committee expected.
Croatian: CHMP je zaključio da je lijek Diacomit dokazao svoju djelotvornost u liječenju SMEI-a, iako su ispitivanja bila skromna i nisu trajala onoliko dugo koliko bi to Povjerenstvo očekivalo.
English: A patient was classified as a ‘responder' if the number of seizures in the second month of treatment was at least 50% lower than the number in the month before treatment was started.
Croatian: Bolesnici su klasificirani kao „odgovaratelji” ako se broj napadaja u drugom mjesecu smanjio za najmanje 50% i odnosu na broj napadaja u mjesecu kada je započeto liječenje.
English: In the first study, 71% of the patients taking Diacomit responded to treatment (15 out of 21), compared with 5% of the placebo group (1 out of 20).
Croatian: U prvom je ispitivanju 71% bolesnika koji su uzimali lijek Diacomit odgovorilo na liječenje (15 od 21), u usporedbi s 5% u grupi koja je uzimala placebo (1 od 20).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Diacomit.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Diacomit.
English: The main studies of Diacomit were in children over three years of age.
Croatian: Glavna ispitivanja lijeka Diacomit provedena su u djece starije od tri godine života.
English: This is a summary of the European public assessment report (EPAR) for Diacomit.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Diacomit.
English: Care must be taken when Diacomit is used at the same time as other medicines.
Croatian: Potrebno je obratiti pozornost prilikom istovremene primjene lijeka Diacomit s drugim lijekovima.
English: Similar results were seen in the second study, with 67% responding to Diacomit (8 out of 12) and 9% to placebo (1 out of 9).
Croatian: Slični su rezultati uočeni u drugom ispitivanju, u kojem je 67% odgovorilo na liječenje lijekom Diacomit (8 od 12) i 9% na liječenje placebom (1 od 9).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Diacomit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Croatian: Sažetak mišljenja Povjerenstva za lijekove za rijetke i teške bolesti o lijeku Diacomit možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: The sachets contain a powder that is used to make up an oral suspension (a liquid with solid particles in it).
Croatian: Vrećice sadrže prašak koji se koristi za pripremu oralne suspenzije (tekućine sa krutim česticama).
English: Decisions regarding the use of Diacomit in younger children should be made on a patient-by-patient basis: it can only be given to younger children if the diagnosis of SMEI has been confirmed.
Croatian: Odluke u vezi primjene lijeka Diacomit u mlađe djece trebaju se donosi za svakog bolesnika individualno: može se davati samo mlađoj djeci ako je dijagnoza SMEI-a potvrđena.
English: The most common side effects with Diacomit (seen in more than 1 in 10 patients) are loss of appetite, weight loss, insomnia (difficulty sleeping), drowsiness, ataxia (inability to co-ordinate muscle movements), hypotonia (low muscle strength) and dystonia (muscle disorders).
Croatian: Najčešće nuspojave od lijeka Diacomit (kod više od 1 na 10 osoba) su gubitak apetita, nesanica (poteškoće sa spavanjem), pospanost, ataksija (nesposobnost koordinacije mišićnih pokreta), hipotonija (smanjena mišićna snaga) i distonija (mišićni poremećaji).
English: Treatment with Diacomit should only be given under the supervision of a doctor who specialises in the diagnosis and management of epilepsy in children (a paediatrician or paediatric neurologist).
Croatian: Liječenje lijekom Diacomit treba primjenjivati samo pod nadzorom specijaliste koji ima iskustva u dijagnosticiranju i zbrinjavanju epilepsije u djece (pedijatra ili pedijatrijskog neurologa).