FrancophonIA/ELRC3.0 huggingface dataset:
English: Each transdermal patch of 10 cm contains 18 mg of rivastigmine.
Croatian: Svaki transdermalni flaster površine 10 cm sadrži 18 mg rivastigmina.
English: Each Prometax 1.5 mg capsule contains 1.5 mg of rivastigmine.
Croatian: Svaka Prometax 1,5 mg kapsula sadrži 1,5 mg rivastigmina.
English: Fall
Croatian: Pad
English: • Push down and turn the child resistant cap to open bottle.
Croatian: • Kako biste otvorili bocu, sigurnosni zatvarač za djecu stisnite prema dolje i zakrenite.
English: No study was conducted with Prometax transdermal patches in subjects with hepatic impairment.
Croatian: Nije provedeno nikakvo ispitivnaje s Prometax transdermalnim flasterima u ispitanika s oštećenjem jetre.
English: You should not breast-feed during treatment with Prometax.
Croatian: Ne smijete dojiti tijekom liječenja Prometaxom.
English: • Renal impairment: No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Croatian: • Oštećenje bubrega: U bolesnika s blagim do umjerenim oštećenjem bubrega (vidjeti dio 5.2).
English: Each transdermal patch of 5 cm contains 9 mg of rivastigmine.
Croatian: Svaki transdermalni flaster površine 5 cm sadrži 9 mg rivastigmina.
English: Each transdermal patch releases 9.5 mg of rivastigmine per 24 hours.
Croatian: Svaki transdermalni flaster oslobađa 9,5 mg rivastigmina u 24 sata.
English: How to remove your Prometax transdermal patch Gently pull at one edge of the patch to remove it slowly from the skin.
Croatian: Lagano povucite jedan kraj flastera kako biste ga polako skinuli s kože.
English: - Prometax 9.5 mg/24 h transdermal patches: Each patch releasing 9.5 mg of rivastigmine per 24 hours is 10 cm and contains 18 mg of rivastigmine.
Croatian: Prometax 9,5 mg/24 h transdermalni flasteri: Svaki flaster koji oslobađa 9,5 mg rivastigmina tijekom 24 sata ima površinu 10 cm i sadrži 18 mg rivastigmina.
English: The outside of the backing layer is beige and labelled with “Prometax”, “13.3 mg/24 h” and “CNFU”.
Croatian: Vanjski dio potpornog sloja je bež boje s oznakama „Prometax“, „13.3 mg/24 h“ i „CNFU“.
English: Mean baseline  SD Mean change at week 24  SD -0.1  9.1 p-value versus placebo * p≤0.05 versus placebo ITT: Intent-To-Treat; LOCF: Last Observation Carried Forward Based on ANCOVA with treatment and country as factors and baseline value as a covariate.
Croatian: Srednja početna vrijednost  SD Srednja promjena nakon 24 tjedna  SD -0,1  9,1 p-vrijednost u odnosu na placebo * p≤0,05 u odnosu na placebo ITT: eng.
English: Each Prometax 3.0 mg capsule contains 3.0 mg of rivastigmine.
Croatian: Svaka Prometax 3,0 mg kapsula sadrži 3,0 mg rivastigmina.
English: - Prometax 4.6 mg/24 h transdermal patches: Each patch releasing 4.6 mg of rivastigmine per 24 hours is 5 cm and contains 9 mg of rivastigmine.
Croatian: Prometax 4,6 mg/24 h transdermalni flasteri: Svaki flaster koji oslobađa 4,6 mg rivastigmina tijekom 24 sata ima površinu 5 cm i sadrži 9 mg rivastigmina.
English: What Prometax contains - The active substance is rivastigmine.
Croatian: Sadržaj pakiranja i druge informacije Što Prometax sadrži - Djelatna tvar je rivastigmin.
English: Rare (may affect up to 1 in 1,000 people)
Croatian: Rijetko (mogu se javiti u do 1 na 1000 ljudi)
English: Where to apply your Prometax transdermal patch
Croatian: Gdje treba postaviti Prometax transdermalni flaster
English: LOCF - Last Observation Carried Forward.
Croatian: Zadnje zapažanje preneseno dalje (LOCF)
English: Each transdermal patch releases 13.3 mg of rivastigmine per 24 hours.
Croatian: Svaki transdermalni flaster oslobađa 13,3 mg rivastigmina u 24 sata.
English: Polyester film, fluoropolymer-coated
Croatian: Zaštitni sloj Poliesterski film, obložen fluoropolimerom.
English: Each Prometax 4.5 mg capsule contains 4.5 mg of rivastigmine.
Croatian: Svaka Prometax 4,5 mg kapsula sadrži 4,5 mg rivastigmina.
English: Prometax 2 mg/ml oral solution
Croatian: Prometax 2 mg/ml oralna otopina
English: 1 transdermal patch per sachet
Croatian: 1 transdermalni flaster po vrećici
English: Oral solution Novartis Pharma GmbH Roonstraße 25
Croatian: Oralna otopina Novartis Pharma GmbH Roonstraße 25
English: Prometax 4.6 mg/24 h transdermal patch Prometax 9.5 mg/24 h transdermal patch Prometax 13.3 mg/24 h transdermal patch
Croatian: Prometax 4,6 mg/24 h transdermalni flaster Prometax 9,5 mg/24 h transdermalni flaster Prometax 13,3 mg/24 h transdermalni flaster
English: Patients and caregivers should be instructed on important administration instructions:
Croatian: O tome bolesnici i njegovatelji trebaju dobiti odgovarajuće upute.
English: Prometax 4.6 mg/24 h transdermal patch Prometax 9.5 mg/24 h transdermal patch Prometax 13.3 mg/24 h transdermal patch rivastigmine
Croatian: Prometax 4,6 mg/24 h transdermalni flaster Prometax 9,5 mg/24 h transdermalni flaster Prometax 13,3 mg/24 h transdermalni flaster rivastigmin
English: The outside of the backing layer is beige and labelled with “Prometax”, “9.5 mg/24 h” and “BHDI”.
Croatian: Vanjski dio potpornog sloja je bež boje s oznakama „Prometax“, „9.5 mg/24 h“ i „BHDI“.
English: Prometax transdermal patches 9.5 mg/24 h
Croatian: Prometax transdermalni flasteri 9,5 mg/24 h
English: They may experience more adverse reactions and may be more likely to discontinue due to adverse reactions.
Croatian: Mogli bi osjetiti više nuspojava te uslijed toga biti skloniji prekidu liječenja zbog nuspojava.
English: • Ulcer in the intestine
Croatian: • Čir u crijevima
English: Transdermal patches
Croatian: Transdermalni flaster
English: • Feeling restless
Croatian: • Osjećaj nemira
English: Keep the patch in the sachet until use.
Croatian: Čuvati flaster u vrećici sve do primjene.
English: At least 4 points improvement on ADAS-Cog with no worsening on ADCSCGIC and ADCS-ADL
Croatian: Poboljšanje od najmanje 4 boda na ADAS-Cog bez pogoršanja na
English: Type III amber glass bottle with a child-resistant cap, dip tube and self aligning plug.
Croatian: Smeđa staklena boca tipa III sa sigurnosnim zatvaračem za djecu i umetnutom cjevčicom s čepom utisnutim u grlo boce.
English: Hepatitis, elevated liver function tests Skin and subcutaneous tissue disorders Common
Croatian: Hepatitis, povišeni rezultati testova funkcije jetre
English: • Use Prometax oral solution within 1 month of opening the bottle.
Croatian: • Prometax oralnu otopinu treba primijeniti unutar mjesec dana od prvog otvaranja bočice.
English: 112 capsules.
Croatian: 56 ili 112 kapsula.
English: Total patients studied Total patients with pre-defined AE(s) Tremor
Croatian: Ukupan broj bolesnika s unaprijed određenom štetnim događajem (događajima)
English: Pruritus, allergic dermatitis (disseminated) General disorders and administration site conditions Common
Croatian: Svrbež, alergijski dermatitis (diseminirani) Opći poremećaji i reakcije na mjestu primjene Često
English: Patients involved in the placebo-controlled study had an MMSE (Mini-Mental State Examination) score of 10-20.
Croatian: Bolesnici uključeni u placebom kontrolirano ispitivanje imali su rezultat na MMSE-u (eng.
English: Female patients in clinical studies were found to be more susceptible than male patients to gastrointestinal adverse reactions and weight loss.
Croatian: Utvrđeno je da su na gastrointestinalne nuspojave i gubitak tjelesne težine bolesnice u kliničkim ispitivanjima bile osjetljivije od muških bolesnika.
English: No study was conducted with Prometax transdermal patches in subjects with renal impairment.
Croatian: Nije provedeno nikakvo ispitivanje s Prometax transdermalnim flasterima u ispitanika s oštećenjem bubrega.
English: • Take off the previous patch before putting ONE new patch on.
Croatian: • Uklonite prethodni flaster prije stavljanja JEDNOG novog flastera.
English: - Prometax 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint “ENA 713 4,5 mg” on the body.
Croatian: - Prometax 4,5 mg tvrde kapsule, sadrže bjelkasti do blago žuti prašak, imaju crvenu kapicu i crveno tijelo, s bijelom oznakom „ENA 713 4,5 mg“ na tijelu kapsule.
English: How to store Prometax
Croatian: Kako čuvati Prometax
English: • Feeling agitated
Croatian: • Osjećaj omaglice
English: Hallucinations, restlessness, nightmares
Croatian: Halucinacije, nemir, noćne more Poremećaji živčanog sustava Često
English: Prometax 2 mg/ml oral solution rivastigmine
Croatian: Prometax 2 mg/ml oralna otopina rivastigmin
English: Children and adolescents There is no relevant use of Prometax in the paediatric population in the treatment of Alzheimer's disease.
Croatian: Pedijatrijska populacija Nema relevantne primjene Prometaxa u pedijatrijskoj populaciji u liječenju Alzheimerove bolesti.
English: organizačná zložka Tel: + 421 2 4820 0600
Croatian: Slovenská republika Sandoz d.d. organizačná zložka Tel: + 421 2 4820 0600
English: • to patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8);
Croatian: • u bolesnika s bolešću sinusnog čvora ili smetnjama provođenja (sinus-atrijski blok,
English: • Uneven heartbeat and poor control of movements Other side effects seen with Prometax transdermal patches and which may occur with the hard capsules:
Croatian: Ostale nuspojave zabilježene s Prometax transdermalnim flasterima a koje se mogu pojaviti s tvrdim kapsulama:
English: • A patient on a dose of 12 mg/day oral rivastigmine can be switched to 9.5 mg/24 h transdermal patches.
Croatian: • Bolesnik koji primjenjuje oralni rivastigmin u dozi od 12 mg/dan može prijeći na transdermalni flaster u dozi od 9,5 mg/24 h.
English: • Do not store above 30°C.
Croatian: • Ne čuvati na temperaturi iznad 30 C.
English: • Rash, itching
Croatian: • Osip, svrbež
English: Filling the syringe
Croatian: Punjenje štrcaljke
English: - Prometax 6.0 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “ENA 713 6 mg” on the body.
Croatian: - Prometax 6,0 mg tvrde kapsule, sadrže bjelkasti do blago žuti prašak, imaju crvenu kapicu i narančasto tijelo, s crvenom oznakom „ENA 713 6 mg“ na tijelu kapsule.
English: • A patient on a dose of 3 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.
Croatian: • Bolesnik koji primjenjuje oralni rivastigmin u dozi od 3 mg/dan može prijeći na transdermalni flaster u dozi od 4,6 mg/24 h.
English: Last Observation Carried Forward
Croatian: Last Observation Carried Forwardprijenos posljednjeg provedenog opažanja
English: Prometax 1.5 mg hard capsules
Croatian: Prometax 1,5 mg tvrde kapsule
English: • Swallow your medicine straight from the syringe.
Croatian: • Progutajte Prometax oralnu otopinu izravno iz štrcaljke.
English: Therefore, the ability of patients with dementia on rivastigmine to continue driving or operating complex machines should be routinely evaluated by the treating physician.
Croatian: Zbog toga odgovorni liječnik treba rutinski procijeniti sposobnost bolesnika s demencijom koji uzimaju rivastigmin, da nastave upravljati vozilima ili raditi na složenim strojevima.
English: The patients studied had an MMSE (Mini-Mental State Examination) score of 10-24.
Croatian: MiniMental State Examination - Skraćeni pregled mentalnog stanja) od 10-20.
English: Prometax 3.0 mg hard capsules
Croatian: Prometax 3,0 mg tvrde kapsule
English: • A patient on a dose of 6 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.
Croatian: • Bolesnik koji primjenjuje oralni rivastigmin u dozi od 6 mg/dan može prijeći na transdermalni flaster u dozi od 4,6 mg/24 h.
English: Common (may affect up to 1 in 10 people)
Croatian: Često (mogu se javiti u do 1 na 10 ljudi)
English: Prometax 1.5 mg hard capsules rivastigmine
Croatian: Prometax 1,5 mg tvrde kapsule rivastigmin
English: Prometax 6.0 mg hard capsules rivastigmine
Croatian: Prometax 6,0 mg tvrde kapsule rivastigmin
English: Prometax 3.0 mg hard capsules rivastigmine
Croatian: Prometax 3,0 mg tvrde kapsule rivastigmin
English: Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “ENA 713 1,5 mg” on body.
Croatian: Bjelkasti do blago žuti prašak u kapsuli sa žutom kapicom i žutim tijelom, s crvenom oznakom „ENA 713 1,5 mg“ na tijelu kapsule.
English: Prometax 4.6 mg/24 h transdermal patch rivastigmine
Croatian: Prometax 4,6 mg/24 h transdermalni flaster rivastigmin
English: Prometax 6.0 mg hard capsules
Croatian: Prometax 6,0 mg tvrde kapsule
English: - Prometax 3.0 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “ENA 713 3 mg” on the body.
Croatian: - Prometax 3,0 mg tvrde kapsule, sadrže bjelkasti do blago žuti prašak, imaju narančastu kapicu i narančasto tijelo, s crvenom oznakom „ENA 713 3 mg“ na tijelu kapsule.
English: Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “ENA 713 4,5 mg” on body.
Croatian: Bjelkasti do blago žuti prašak u kapsuli s crvenom kapicom i crvenim tijelom, s bijelom oznakom „ENA 713 4,5 mg“ na tijelu kapsule.
English: • Uneven heartbeat
Croatian: • Nepravilni otkucaji srca
English: Prometax 4.5 mg hard capsules rivastigmine
Croatian: Prometax 4,5 mg tvrde kapsule rivastigmin
English: ITT: Intent-To-Treat; RDO: Retrieved Drop Outs
Croatian: Retrieved Drop Outs - slučajevi koji su ispali, a uzeti su u obzir); LOCF (eng.
English: 1 capsule contains 1.5 mg rivastigmine present as rivastigmine hydrogen tartrate.
Croatian: 1 kapsula sadrži 1,5 mg rivastigmina u obliku rivastigminhidrogentartarata.
English: Prometax 4.5 mg hard capsules
Croatian: Prometax 4,5 mg tvrde kapsule
English: Malaise
Croatian: Nemir
English: 1 capsule contains 6.0 mg rivastigmine present as rivastigmine hydrogen tartrate.
Croatian: 1 kapsula sadrži 6,0 mg rivastigmina u obliku rivastigminhidrogentartarata.
English: Dizziness
Croatian: Malaksalost
English: 1 capsule contains 4.5 mg rivastigmine present as rivastigmine hydrogen tartrate.
Croatian: 1 kapsula sadrži 4,5 mg rivastigmina u obliku rivastigminhidrogentartarata.
English: Prometax 4.6 mg/24 h transdermal patch
Croatian: Prometax 4,6 mg/24 h transdermalni flaster
English: Prometax 9.5 mg/24 h transdermal patch rivastigmine
Croatian: Prometax 9,5 mg/24 h transdermalni flaster rivastigmin
English: Prometax 13.3 mg/24 h transdermal patch
Croatian: Prometax 13.3 mg/24 h transdermalni flaster
English: Patients involved in this study had an MMSE (Mini-Mental State Examination) score of 10-24.
Croatian: Ispitivani bolesnici imali su broj bodova od 10 do 24 na MMSE ljestvici (eng.
English: 1 capsule contains 3.0 mg rivastigmine present as rivastigmine hydrogen tartrate.
Croatian: 1 kapsula sadrži 3,0 mg rivastigmina u obliku rivastigminhidrogentartarata.
English: Prometax 9.5 mg/24 h transdermal patch
Croatian: Prometax 9.5 mg/24 h transdermalni flaster
English: Prometax 13.3 mg/24 h transdermal patch rivastigmine
Croatian: Prometax 13,3 mg/24 h transdermalni flaster rivastigmin
English: Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “ENA 713 6 mg” on body.
Croatian: Bjelkasti do blago žuti prašak u kapsuli s crvenom kapicom i narančastim tijelom, s crvenom oznakom „ENA 713 6 mg“ na tijelu kapsule.
English: - if you have, or have ever had, impaired liver function.
Croatian: - ako imate ili ste imali poremećaj funkcije jetre. - ako imate drhtavicu.
English: • Heartburn
Croatian: • Tjeskoba
English: • Too much saliva
Croatian: • Prekomjerno stvaranje sline
English: Gait disturbance
Croatian: Poremećaj hoda
English: • The previous day's patch must be removed before applying a new one every day (see section 4.9).
Croatian: Bolesnici i njegovatelji trebaju dobiti važne upute o primjeni: • Flaster od prethodnog dana mora se ukloniti prije primjene novog flastera svakog dana (vidjeti dio
English: Quinoline yellow WS dye (E104) Purified water
Croatian: 6.1 Popis pomoćnih tvari natrijev benzoat citratna kiselina natrijev citrat boja kinolin žuta WS (E104) pročišćena voda
English: • Put the child resistant cap back on the bottle to close it.
Croatian: • Zatvorite bocu pomoću sigurnosnog zatvarača za djecu.
English: The active substance of Prometax is rivastigmine.
Croatian: Prometaxa je rivastigmin.
English: • Uneven heartbeat and poor control of movements Other side effects seen with Prometax transdermal patches and which may occur with the oral solution:
Croatian: Ostale nuspojave zabilježene s Prometax transdermalnim flasterima a koje se mogu pojaviti s oralnom otopinom:
English: Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Croatian: Lek Pharmaceuticals d.d. Tel: +386 1 580 33 27
English: Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint “ENA 713 3 mg” on body.
Croatian: Bjelkasti do blago žuti prašak u kapsuli s narančastom kapicom i narančastim tijelom, s crvenom oznakom „ENA 713 3 mg“ na tijelu kapsule.
English: 48-week active comparator controlled study
Croatian: Tjedan 48 početne vrijednosti
English: EU/1/98/092/029 60 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/030 90 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/041 60 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/042 90 transdermal patches (sachet: paper/PET/PE/alu/PA)
Croatian: EU/1/98/092/029 60 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/030 90 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/041 60 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA)
English: EU/1/98/092/023 7 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/024 30 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/035 7 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/036 30 transdermal patches (sachet: paper/PET/PE/alu/PA)
Croatian: EU/1/98/092/023 7 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/024 30 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/035 7 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA) EU/1/98/092/036 30 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA)
English: EU/1/98/092/019 7 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/020 30 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/031 7 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/032 30 transdermal patches (sachet: paper/PET/PE/alu/PA)
Croatian: EU/1/98/092/019 7 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/020 30 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/031 7 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA) EU/1/98/092/032 30 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA)
English: • A patient on a stable and well tolerated dose of 9 mg/day oral rivastigmine can be switched to
Croatian: • Bolesnik na stabilnoj dozi od 9 mg/dan oralnog rivastigmina koju dobro podnosi može prijeći na transdermalni flaster u dozi od 9,5 mg/24 h.
English: EU/1/98/092/027 7 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/028 30 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/039 7 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/040 30 transdermal patches (sachet: paper/PET/PE/alu/PA)
Croatian: EU/1/98/092/027 7 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/028 30 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/039 7 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA) EU/1/98/092/040 30 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA)
English: Mean data shown for convenience, categorical analysis performed using van Elteren test ITT: Intent-To-Treat; RDO: Retrieved Drop Outs; LOCF: Last Observation Carried Forward
Croatian: Zbog prikladnosti su prikazani prosječni podaci, analiza po kategorijama provedena je primjenom van Elterenovog testa.
English: EU/1/98/092/021 60 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/022 90 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/033 60 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/034 90 transdermal patches (sachet: paper/PET/PE/alu/PA)
Croatian: EU/1/98/092/021 60 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/022 90 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/033 60 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA) EU/1/98/092/034 90 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA)
English: EU/1/98/092/025 60 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/026 90 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/037 60 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/038 90 transdermal patches (sachet: paper/PET/PE/alu/PA)
Croatian: EU/1/98/092/025 60 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/026 90 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/037 60 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA)
English: Each ml contains rivastigmine hydrogen tartrate corresponding to 2 mg rivastigmine.
Croatian: Što Prometax sadrži - Djelatna tvar je rivastigminhidrogentartarat Svaki ml sadrži rivastigminhidrogentartarat u količini koja odgovara 2,0 mg baze rivastigmina.
English: Dose escalation
Croatian: Potporni sloj
English: • Some people who have been violently sick have had tearing of the tube that connects your mouth with your stomach (oesophagus)
Croatian: • U nekih je bolesnika koji su imali izrazitu mučninu došlo do pucanja cijevi koja povezuje
English: • Fainting
Croatian: • Drhtanje
English: • The recommended usual daily dose is Prometax 9.5 mg/24 h. If well tolerated, the treating physician may consider increasing the dose to 13.3 mg/24 h.
Croatian: • Preporučena uobičajena dnevna doza je Prometax 9,5 mg/24 h.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 1.5 mg rivastigmine.
Croatian: Svaka kapsula sadrži 1,5 mg rivastigmina u obliku rivastigminhidrogentartarata.
English: • Nightmares
Croatian: • Noćne more
English: Following administration of
Croatian: Srednja promjena nakon
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 3.0 mg rivastigmine.
Croatian: Svaka kapsula sadrži 3,0 mg rivastigmina u obliku rivastigminhidrogentartarata.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 4.5 mg rivastigmine.
Croatian: Svaka kapsula sadrži 4,5 mg rivastigmina u obliku rivastigminhidrogentartarata.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 6.0 mg rivastigmine.
Croatian: Svaka kapsula sadrži 6,0 mg rivastigmina u obliku rivastigminhidrogentartarata.
English: It is not for use in women and must not be given to women who are or who may be pregnant.
Croatian: Nije za primjenu u žena i ne smije se davati ženama koje su trudne ili bi mogle biti trudne.
English: The full EPAR for Zytiga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Zytiga nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The recommended dose of Zytiga is 1,000 mg taken once a day at least two hours after eating and at least one hour before further food.
Croatian: Preporučena doza lijeka Zytiga je 1 000 mg jedanput na dan najmanje dva sata nakon jela i najmanje jedan sat prije sljedećeg obroka.
English: Treatment may be resumed at a reduced dose if liver function returns to normal.
Croatian: Liječenje se može nastaviti uz manju dozu ako se funkcija jetre vrati na normalnu razinu.
English: Other information about Zytiga
Croatian: Ostale informacije o lijeku Zytiga
English: Zytiga abiraterone acetate
Croatian: Zytiga abirateronacetat
English: Zytiga is available as tablets (250 and 500 mg) and can only be obtained with a prescription.
Croatian: Lijek Zytiga dostupan je u obliku tableta (od 250 i 500 mg) te se izdaje samo na liječnički recept.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zytiga on 5 September 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet lijeka Zytigakoje vrijedi na prostoru Europske unije od 5. rujna 2011.