FrancophonIA/ELRC3.0 huggingface dataset:
English: Pregabalin Zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Croatian: Pregabalin Zentiva indiciran je kao dodatna terapija u odraslih osoba s parcijalnim napadajima, sa ili bez sekundarne generalizacije.
English: Do not stop taking Pregabalin Zentiva unless your doctor tells you to.
Croatian: Nemojte prestati uzimati Pregabalin Zentiva ako Vam to ne kaže liječnik.
English: Pregabalin Zentiva is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
Croatian: Pregabalin Zentiva se koristi za liječenje nekih oblika epilepsije (parcijalnih napadaja sa ili bez sekundarne generalizacije) u odraslih osoba.
English: If you stop taking Pregabalin Zentiva
Croatian: Ako prestanete uzimati Pregabalin Zentiva
English: For three times a day take Pregabalin Zentiva once in the morning, once in the afternoon and once in the evening, at about the same time each day.
Croatian: Ako Pregabalin Zentiva uzimate tri puta na dan, uzmite jednu dozu ujutro, jednu dozu poslijepodne te jednu navečer, svakoga dana otprilike u isto vrijeme.
English: Results of a 12-week placebo controlled study of 295 paediatric patients aged 4 to 16 years and a 14-day placebo-controlled study of 175 paediatric patients aged 1 month to younger than 4 years of age performed to evaluate the efficacy and safety of pregabalin as adjunctive therapy for the treatment of partial onset seizures and a 1 year open label safety study in 54 paediatric patients from 3 months to 16 years of age with epilepsy indicate that the adverse events of pyrexia and upper respiratory infections were observed more frequently than in adult studies of patients with epilepsy (see sections 4.2, 4.8 and 5.2).
Croatian: Rezultati 12-tjednog placebom kontroliranog ispitivanja koje je provedeno u 295 pedijatrijskih bolesnika u dobi od 4 do 16 godina i 14-dnevnog placebom kontroliranog ispitivanja koje je provedeno u 175 pedijatrijskih bolesnika u dobi od 1 mjeseca do manje od 4 godine radi procjene djelotvornosti i sigurnosti pregabalina kao dodatne terapije za liječenje parcijalnih napadaja i jednogodišnjeg otvorenog ispitivanja sigurnosti u 54 pedijatrijska bolesnika u dobi od 3 mjeseca do 16 godina s epilepsijom ukazuju na to da su štetni događaji pireksija i infekcija gornjih dišnih putova zabilježeni češće nego u ispitivanjima u odraslih bolesnika s epilepsijom (vidjeti dijelove 4.2, 4.8 i 5.2).
English: Adjunctive treatment
Croatian: Dodatna terapija
English: What Pregabalin Zentiva contains
Croatian: Što Pregabalin Zentiva sadrži
English: is used to treat long lasting pain caused by damage to the nerves.
Croatian: Pregabalin Zentiva koristi se za liječenje dugotrajne boli uzrokovane oštećenjem živaca.
English: Central nervous system influencing medical products
Croatian: Lijekovi koji utječu na središnji živčani sustav
English: If you forget to take Pregabalin Zentiva
Croatian: Ako ste zaboravili uzeti Pregabalin Zentiva
English: For twice a day take Pregabalin Zentiva once in the morning and once in the evening, at about the same time each day.
Croatian: Ako Pregabalin Zentiva uzimate dva puta na dan, uzmite jednu dozu ujutro te jednu navečer, svakoga dana otprilike u isto vrijeme.
English: Hepatic failure, hepatitis
Croatian: Vrlo rijetko zatajenje jetre, hepatitis
English: Pregabalin Zentiva belongs to a group of medicines used to treat epilepsy, neuropathic pain and generalised anxiety disorder (GAD) in adults.
Croatian: Pregabalin Zentiva pripada skupini lijekova koji se koriste za liječenja epilepsije, neuropatske boli i generaliziranog anksioznog poremećaja (GAP) u odraslih osoba.
English: The pregabalin safety profile observed in four paediatric studies in patients with partial seizures with or without secondary generalisation (12-week efficacy and safety study in patients 4 to 16 years of age, n = 295; 14-day efficacy and safety study in patients 1 month to younger than 4 years of age, n = 175; pharmacokinetic and tolerability study, n = 65; and 1 year open label follow on safety study, n = 54) was similar to that observed in the adult studies of patients with epilepsy.
Croatian: Sigurnosni profil pregabalina zabilježen u četiri pedijatrijska ispitivanja u bolesnika s parcijalnim napadajima sa sekundarnom generalizacijom ili bez nje (12-tjedno ispitivanje djelotvornosti i sigurnosti u bolesnika u dobi od 4 do 16 godina, n=295, 14-dnevno ispitivanje djelotvornosti i sigurnosti u bolesnika u dobi od 1 mjeseca do manje od 4 godine, n=175, s parcijalnim napadajima, n=295, ispitivanje farmakokinetike i podnošljivosti, n=65 i jednogodišnje otvoreno ispitivanje praćenja sigurnosti, n=54) bio je sličan onome zapaženom u ispitivanjima u odraslih bolesnika s epilepsijom.
English: The percentage of subjects with at least a 50% reduction in partial onset seizures as compared to baseline was 40.6% of subjects treated with pregabalin 10 mg/kg/day (p = 0.0068 versus placebo), 29.1% of subjects treated with pregabalin 2.5 mg/kg/day (p = 0.2600 versus placebo) and 22.6% of those receiving placebo.
Croatian: Najmanje 50%-tno smanjenje parcijalnih napadaja od početka ispitivanja imalo je 40,6% ispitanika liječenih pregabalinom u dozi od 10 mg/kg na dan (p=0,0068 naspram placeba), 29,1% ispitanika liječenih pregabalinom u dozi od 2,5 mg/kg na dan (p=0,2600 naspram placeba ) i 22,6% onih koji su primali placebo.
English: Pregabalin Dose Adjustment Based on Renal Function
Croatian: Prilagodba doze pregabalina na temelju funkcije bubrega
English: Single dose +
Croatian: jedna doza
English: At therapeutic exposures, there was evidence of CNS clinical signs of hyperactivity and bruxism and some changes in growth (transient body weight gain suppression).
Croatian: SŽS u smislu hiperaktivnosti i bruksizma te neke promjene u rastu (prolazna supresija porasta tjelesne mase).
English: Shellac
Croatian: − šelak
English: In the 12-week placebo controlled study, paediatric patients (4 to 16 years of age) were assigned to pregabalin 2.5 mg/kg/day (maximum, 150 mg/day), pregabalin 10 mg/kg/day (maximum, 600 mg/day), or placebo.
Croatian: U 12-tjednom placebom kontroliranom ispitivanju pedijatrijski su bolesnici (u dobi od 4 do 16 godina) dobivali pregabalin u dozi od 2,5 mg/kg na dan (maksimalno 150 mg na dan), pregabalin 10 mg/kg na dan (maksimalno 600 mg na dan) ili placebo.
English: Very rare: may affect up to 1 in 10,000 people
Croatian: Vrlo rijetke : mogu se javiti u do 1 na 10 000 osoba
English: In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, central nervous system adverse reactions and especially somnolence was increased.
Croatian: Liječenje centralne neuropatske boli uzrokovane ozljedom leđne moždine U liječenju centralne neuropatske boli uzrokovane ozljedom leđne moždine zabilježena je povećana incidencija nuspojava općenito te nuspojava središnjeg živčanog sustava, a osobito somnolencije.
English: How to take Pregabalin Zentiva
Croatian: Kako uzimati Pregabalin Zentiva
English: Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol.
Croatian: Ispitivanja in vivo i analiza populacijske farmakokinetike Sukladno tome, u ispitivanjima in vivo nisu opažene klinički značajne farmakokinetičke interakcije između pregabalina i fenitoina, karbamazepina, valproične kiseline, lamotrigina, gabapentina, lorazepama, oksikodona ili etanola.
English: You should take Pregabalin Zentiva in addition to your current treatment.
Croatian: Pregabalin Zentiva morate uzimati kao dodatak postojećim lijekovima.
English: Oedema peripheral, oedema, gait abnormal, fall, feeling drunk, feeling abnormal, fatigue
Croatian: Često periferni edem, edem, neuobičajen hod, pad, osjećaj pijanosti, neuobičajeno osjećanje, umor
English: Pregabalin Zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults.
Croatian: Neuropatska bol Pregabalin Zentiva indiciran je za liječenje periferne i centralne neuropatske boli u odraslih osoba.
English: Capsules content Lactose monohydrate, Pregelatinized maize starch, Talc.
Croatian: Sadržaj kapsula laktoza hidrat kukuruzni škrob, prethodno geliran talk
English: Pregabalin Zentiva contains lactose monohydrate.
Croatian: Pregabalin Zentiva sadrži laktozu hidrat.
English: Hallucination, panic attack, restlessness, agitation, depression, depressed mood, elevated mood, aggression, mood swings, depersonalisation, word finding difficulty, abnormal dreams, libido increased, anorgasmia, apathy
Croatian: Manje često halucinacije, napadaj panike, nemir, agitacija, depresija, depresivno raspoloženje, povišeno raspoloženje, agresija, promjene raspoloženja, depersonalizacija, poteškoće u pronalaženju riječi, neuobičajeni snovi, pojačan libido, anorgazmija, apatija
English: Pregabalin Zentiva is for oral use only.
Croatian: Pregabalin Zentiva namijenjen je samo za peroralnu primjenu.
English: Pregabalin Zentiva is used to treat generalised anxiety disorder (GAD).
Croatian: Pregabalin Zentiva se koristi za liječenje generaliziranog anksioznog poremećaja (GAP).
English: Pregabalin Zentiva 25 mg hard capsules Pregabalin Zentiva 50 mg hard capsules Pregabalin Zentiva 75 mg hard capsules Pregabalin Zentiva 100 mg hard capsules Pregabalin Zentiva 150 mg hard capsules Pregabalin Zentiva 200 mg hard capsules Pregabalin Zentiva 225 mg hard capsules Pregabalin Zentiva 300 mg hard capsules Pregabalin
Croatian: Pregabalin Zentiva 25 mg tvrde kapsule Pregabalin Zentiva 50 mg tvrde kapsule Pregabalin Zentiva 75 mg tvrde kapsule Pregabalin Zentiva 100 mg tvrde kapsule Pregabalin Zentiva 150 mg tvrde kapsule Pregabalin Zentiva 200 mg tvrde kapsule Pregabalin Zentiva 225 mg tvrde kapsule Pregabalin Zentiva 300 mg tvrde kapsule pregabalin
English: How to store Pregabalin Zentiva
Croatian: Kako čuvati Pregabalin Zentiva
English: Pregabalin Zentiva 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg hard capsules are packed into PVC/alu blisters as primary packaging.
Croatian: Pregabalin Zentiva 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg i 300 mg tvrde kapsule zapakirane su u PVC/alu blistere kao primarno pakiranje.
English: • Changes in eyesight, unusual eye movement, changes in vision including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness on standing, sensitive skin, loss of taste, burning sensation, tremor on movement, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling unwell.
Croatian: • promjene vida, neuobičajeni pokreti očiju, promjene vida uključujući gubitak perifernog vida (kao da gledate kroz cijev), bljeskovi svjetla, trzajni pokreti, smanjeni refleksi, pojačana aktivnost, omaglica pri ustajanju, osjetljivost kože, gubitak osjeta okusa, osjećaj pečenja,
English: Renal failure, oliguria, urinary retention
Croatian: Rijetko zatajenje bubrega, oligurija, retencija mokraće
English: 14 hard capsules 21 hard capsules 56 hard capsules 84 hard capsules 98 hard capsules 100 hard capsules
Croatian: 14 tvrdih kapsula 21 tvrda kapsula 56 tvrdih kapsula 84 tvrde kapsule 98 tvrdih kapsula 100 tvrdih kapsula
English: 150 mg capsules
Croatian: Kapsule od 150 mg
English: 21 hard capsules 84 hard capsules 98 hard capsules 100 hard capsules
Croatian: 21 tvrda kapsula 84 tvrde kapsule 98 tvrdih kapsula 100 tvrdih kapsula
English: Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.
Croatian: Jedna tvrda kapsula sadrži 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg ili 300 mg pregabalina.
English: Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm
Croatian: Često grčevi u mišićima, artralgija, bol u leđima, bol u udovima, cervikalni spazam
English: Manufacturer Zentiva, k.s.
Croatian: Proizvođač Zentiva, k.s.
English: Pregabalin Zentiva 100 mg, 200 mg is available in pack of 21, 84, 98 and 100 hard capsules.
Croatian: Pregabalin Zentiva 100 mg i 200 mg su dostupni u pakiranju od 21, 84, 98 i 100 tvrdih kapsula.
English: Pregabalin Zentiva 75 mg, 150 mg, 225 mg and 300 mg is available in pack of 14, 56, 98 and 100 hard capsules.
Croatian: Pregabalin Zentiva 75 mg, 150 mg, 225 mg i 300 mg su dostupni u pakiranju od 14, 56, 98 i 100 tvrdih kapsula.
English: Generalised anxiety disorder Pregabalin Zentiva is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
Croatian: Pregabalin Zentiva indiciran je za liječenje generaliziranog anksioznog poremećaja (GAP) u odraslih osoba.
English: Pregabalin Zentiva 25 mg and 50 mg is available in pack of 14, 21, 56, 84, 98 and 100 hard capsules.
Croatian: Pregabalin Zentiva 25 mg i 50 mg su dostupni u pakiranju od 14, 21, 56, 84, 98 i 100 tvrdih kapsula.
English: Table 2: Pregabalin Adverse Drug Reactions
Croatian: Tablica 2: Nuspojave pregabalina
English: Black iron oxide (E172) Titanium dioxide (E171) Gelatin
Croatian: − titanijev dioksid (E171)
English: België/Belgique/Belgien Zentiva, k.s.
Croatian: België/Belgique/Belgien
English: Pregabalin Zentiva 150 mg hard capsules: EU/1/15/1021/017
Croatian: Pregabalin Zentiva 150 mg tvrde kapsule EU/1/15/1021/017
English: Rhabdomyolysis
Croatian: • grlobolja
English: Pregabalin Zentiva contains lactose monohydrate If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
English: Pregabalin Zentiva 300 mg hard capsules: EU/1/15/1021/026
Croatian: Pregabalin Zentiva 300 mg tvrde kapsule EU/1/15/1021/026
English: Pregabalin Zentiva 225 mg hard capsules: EU/1/15/1021/023
Croatian: Pregabalin Zentiva 225 mg tvrde kapsule EU/1/15/1021/023
English: Pregabalin Zentiva 50 mg hard capsules: EU/1/15/1021/006
Croatian: Pregabalin Zentiva 50 mg tvrde kapsule EU/1/15/1021/006
English: Pregabalin Zentiva 225 mg hard capsules Capsule cap
Croatian: Pregabalin Zentiva 225 mg tvrde kapsule Kapica kapsule
English: Pregabalin Zentiva 25 mg hard capsules Capsule cap and body
Croatian: Pregabalin Zentiva 25 mg tvrde kapsule Kapica i tijelo kapsule
English: Pregabalin Zentiva 75 mg hard capsules: EU/1/15/1021/011
Croatian: Pregabalin Zentiva 75 mg tvrde kapsule EU/1/15/1021/011
English: Pregabalin Zentiva 75 mg
Croatian: Kapsule od 75 mg
English: Pregabalin Zentiva 150 mg hard capsules
Croatian: Pregabalin Zentiva 150 mg tvrde kapsule
English: Pregabalin Zentiva 75 mg hard capsules Capsule cap
Croatian: Pregabalin Zentiva 75 mg tvrde kapsule Kapica kapsule
English: Pregabalin Zentiva 300 mg hard capsules Capsule cap
Croatian: Pregabalin Zentiva 300 mg tvrde kapsule Kapica kapsule
English: Pregabalin Zentiva 100 mg hard capsules: EU/1/15/1021/014
Croatian: Pregabalin Zentiva 100 mg tvrde kapsule EU/1/15/1021/014
English: Dizziness, somnolence, loss of consciousness, confusion, and mental impairment
Croatian: • poremećaj pažnje, nespretnost, poremećaj pamćenja, gubitak pamćenja, nevoljno drhtanje
English: Pregabalin Zentiva 200 mg hard capsules: EU/1/15/1021/020
Croatian: Pregabalin Zentiva 200 mg tvrde kapsule EU/1/15/1021/020
English: Pregabalin Zentiva 50 mg hard capsules
Croatian: Pregabalin Zentiva 50 mg tvrde kapsule
English: Pregabalin Zentiva 25 mg hard capsules: EU/1/15/1021/001
Croatian: Pregabalin Zentiva 25 mg tvrde kapsule EU/1/15/1021/001
English: Pregabalin Zentiva 300 mg hard capsules
Croatian: Pregabalin Zentiva 300 mg tvrde kapsule
English: Pregabalin Zentiva 225 mg hard capsules
Croatian: Pregabalin Zentiva 225 mg tvrde kapsule
English: 300 mg capsules Red cap and light grey body; approx. 21,7 mm in length, hard gelatin capsule with imprinting “300”, containing almost white powder.
Croatian: Tvrda želatinska kapsula duljine približno 21,7 mm, s crvenom kapicom, svjetlosivim tijelom i otisnutom oznakom “300”, koja sadrži gotovo bijeli prašak.
English: Pregabalin Zentiva 200 mg hard capsules Each hard capsule contains 200 mg of pregabalin.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tvrda kapsula sadrži 200 mg pregabalina.
English: Pregabalin Zentiva 75 mg hard capsules
Croatian: Pregabalin Zentiva 75 mg tvrde kapsule
English: Pregabalin Zentiva 225 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Zentiva 225 mg
English: Black iron oxide (E172) Propylene glycol
Croatian: − željezov oksid, crni (E172)
English: Pregabalin Zentiva 300 mg hard capsules Pregabalin
Croatian: Pregabalin Zentiva 300 mg tvrde kapsule pregabalin
English: Pregabalin Zentiva 200 mg hard capsules Pregabalin
Croatian: Pregabalin Zentiva 200 mg tvrde kapsule pregabalin
English: Pregabalin Zentiva 225 mg hard capsules Pregabalin
Croatian: Pregabalin Zentiva 225 mg tvrde kapsule pregabalin
English: Pregabalin Zentiva 200 mg hard capsules
Croatian: Pregabalin Zentiva 200 mg tvrde kapsule
English: Pregabalin Zentiva 150 mg hard capsules Pregabalin
Croatian: Pregabalin Zentiva 150 mg tvrde kapsule pregabalin
English: Pregabalin Zentiva 100 mg hard capsules Pregabalin
Croatian: Pregabalin Zentiva 100 mg tvrde kapsule pregabalin
English: Pregabalin Zentiva 50 mg hard capsules Pregabalin
Croatian: Pregabalin Zentiva 50 mg tvrde kapsule pregabalin
English: Pregabalin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in the elderly population.
Croatian: Omaglica, somnolencija, gubitak svijesti, konfuzija i slabljenje mentalnih sposobnosti Liječenje pregabalinom povezuje se s pojavom omaglice i somnolencije, što može povećati broj slučajnih ozljeda (padova) u starijoj populaciji.
English: Pregabalin Zentiva 100 mg hard capsules
Croatian: Pregabalin Zentiva 100 mg tvrde kapsule
English: Pregabalin Zentiva 300 mg hard capsules Each hard capsule contains 300 mg of pregabalin.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tvrda kapsula sadrži 300 mg pregabalina.
English: Pregabalin Zentiva 100 mg hard capsules Each hard capsule contains 100 mg of pregabalin.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tvrda kapsula sadrži 100 mg pregabalina.
English: • Breast pain.
Croatian: • bol u dojkama
English: Pregabalin Zentiva 225 mg hard capsules Each hard capsule contains 225 mg of pregabalin.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tvrda kapsula sadrži 225 mg pregabalina.
English: The following events have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and dizziness, suggestive of physical dependence.
Croatian: proljev, sindrom nalik gripi, nervoza, depresija, bol, konvulzije, hiperhidroza i omaglica, koji upućuju na fizičku ovisnost.
English: Pregabalin Zentiva 50 mg hard capsules Each hard capsule contains 50 mg of pregabalin.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tvrda kapsula sadrži 50 mg pregabalina.
English: Pregabalin Zentiva 25 mg hard capsules Pregabalin
Croatian: Pregabalin Zentiva 25 mg tvrde kapsule pregabalin
English: Amenorrhoea, breast discharge, breast enlargement, gynaecomastia General disorders and administration site conditions Common
Croatian: Rijetko amenoreja, iscjedak iz dojke, povećanje dojki, ginekomastija
English: Pregabalin Zentiva 150 mg hard capsules Each hard capsule contains 150 mg of pregabalin.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tvrda kapsula sadrži 150 mg pregabalina.
English: Pregabalin Zentiva 25 mg hard capsules
Croatian: Pregabalin Zentiva 25 mg tvrde kapsule
English: 25 mg capsules Light grey cap and light grey body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “25”, containing almost white powder.
Croatian: Tvrda želatinska kapsula duljine približno 15,9 mm, sa svjetlosivom kapicom, svjetlosivim tijelom i otisnutom oznakom “25”, koja sadrži gotovo bijeli prašak.
English: Pregabalin Zentiva 75 mg hard capsules Each hard capsule contains 75 mg of pregabalin.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tvrda kapsula sadrži 75 mg pregabalina.
English: Pregabalin Zentiva 75 mg hard capsules Pregabalin
Croatian: Pregabalin Zentiva 75 mg tvrde kapsule pregabalin
English: Pregabalin Zentiva 25 mg hard capsules Each hard capsule contains 25 mg of pregabalin.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tvrda kapsula sadrži 25 mg pregabalina.
English: Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin.
Croatian: − željezov oksid, crveni (E172)
English: Pregabalin Zentiva 200 mg
Croatian: Kapsule od 200 mg
English: Pregabalin Zentiva 100 mg
Croatian: Kapsule od 100 mg
English: • Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal.
Croatian: (tremor), poteškoće pri govoru, osjećaj trnaca, utrnulost, sedacija, letargija, nesanica, umor,
English: Pregabalin Zentiva 50 mg
Croatian: Kapsule od 50 mg
English: Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin
Croatian: − željezov oksid, žuti (E172)
English: PV-Lithuania@zentiva.com
Croatian: PV-Belgium@zentiva.com
English: Pregabalin Zentiva 25 mg
Croatian: Kapsule od 25 mg
English: Czech Republic Krka d.d., Novo mesto
Croatian: Češka Republika Krka d.d., Novo mesto
English: Czech Republic Alkem Pharma GmbH
Croatian: Češka Republika Alkem Pharma
English: Marketing Authorisatio n Holder
Croatian: Nositelj odobrenja
English: Active Substance
Croatian: Djelatna tvar
English: Ricefan 500 mg Cefuroxime 500 mg Film-coated tablet
Croatian: Ricefan 500 mg Cefuroksim 500 mg Filmom obložena tableta
English: Cefuroxime 500mg film-coated tablets
Croatian: Cefuroxime 500mg filmcoated tablets
English: Ricefan 250 mg Cefuroxime 250 mg Film-coated tablet
Croatian: Ricefan 250 mg Cefuroksim 250 mg Filmom obložena tableta
English: Cefuroxime 250 mg Tablet
Croatian: Cefuroksim 250 mg Tableta
English: Cefuroxime 500 mg Tablet
Croatian: Cefuroksim 500 mg Tableta
English: Cefuroxime 250mg film-coated tablets
Croatian: Cefuroxime 250mg filmcoated tablets
English: 14 October 2016 EMA/659373/2016 EMEA/H/C/004306
Croatian: EMA/659373/2016 EMEA/H/C/004306
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing its application because of a change in commercial strategy.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da povlači zahtjev zbog izmjene komercijalne strategije.
English: Based on the review of the data at the time of the withdrawal, the CHMP had asked the company to provide clarification on some aspects of manufacturing, storage and plans to monitor safety and effectiveness of the medicine after authorisation.
Croatian: Na temelju pregleda podataka, u trenutku povlačenja, CHMP je zatražio od tvrtke da pruži pojašnjenja u pogledu nekih aspekata proizvodnje, skladištenja i planova za nadzor sigurnosti i djelotvornosti lijeka nakon davanja odobrenja.
English: This means that it was intended to be similar to a ‘reference medicine' already authorised in the European Union called Alimta.
Croatian: To znači da je trebao biti sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Alimta.
English: The active substance in both medicines, pemetrexed, is changed in the body into an active form that blocks enzymes needed to make genetic material (DNA and RNA).
Croatian: Djelatna tvar obaju lijekova, pemetreksed, mijenja se u tijelu u djelatni oblik koji blokira enzime potrebne za stvaranje genetskog materijala (DNK i RNK).
English: This prevents the cancer cells from growing and dividing, while normal cells are only slightly affected.
Croatian: To sprečava rast i diobu stanica raka, pri čemu je utjecaj na normalne stanice tek neznatan.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for this product.
Croatian: Tvrtka je obavijestila CHMP da nema kliničkih ispitivanja ili programa milosrdnog davanja ovog lijeka koji su u tijeku.
English: active form happens more readily in cancer cells than in normal cells.
Croatian: Do promjene u djelatni oblik dolazi prije u stanicama raka nego u normalnim stanicama.