FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who develop application site reactions suggestive of allergic contact dermatitis to rivastigmine patch and who still require rivastigmine treatment should only be switched to oral rivastigmine after negative allergy testing and under close medical supervision.
Croatian: Bolesnici u kojih se razviju reakcije na mjestu primjene, koje ukazuju na alergijski kontaktni dermatitis na rivastigminski flaster, te koje još treba liječiti rivastigminom, treba samo prebaciti na oralni rivastigmin nakon negativnog testa na alergiju te pod strogim liječničkim nadzorom.
English: These events led to the discontinuation of rivastigmine in some cases (e.g. discontinuations due to tremor 1.7 % on rivastigmine vs. 0 % on placebo).
Croatian: U nekim su slučajevima ti događaji doveli do prekida liječenja rivastigminom (npr. prekidi liječenja zbog tremora u 1,7 % bolesnika na rivastigminu naspram 0 % na placebu).
English: Not known (frequency cannot be estimated from the available data) • Allergic reaction where the patch was used, such as blisters or skin inflammation
Croatian: Nepoznato (učestalost nuspojava ne može se procijeniti iz dostupnih podataka) • Alergijska reakcija na mjestu primjene flastera, kao što su mjehurići ili upala kože
English: If you have to undergo surgery whilst taking Rivastigmine Actavis, tell your doctor before you are given any anaesthetics, because Rivastigmine Actavis may exaggerate the effects of some muscle relaxants during anaesthesia.
Croatian: Ako se, tijekom primjene Rivastigmina Actavis, morate podvrgnuti operaciji, obavijestite liječnika prije nego što Vam primijeni bilo koji anestetik, jer Rivastigmin Actavis može tijekom anestezije pojačati učinke nekih mišićnih relaksansa.
English: Do not take Rivastigmine Actavis
Croatian: Nemojte uzimati Rivastigmin Actavis
English: Patients without visual hallucinations hallucinations
Croatian: Bolesnici bez vidnih halucinacija
English: Rivastigmine Actavis is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Croatian: Rivastigmin Actavis se primjenjuje u liječenju poremećaja pamćenja u odraslih bolesnika s blagom do umjerenom Alzheimerovom bolešću, progresivnim poremećajem mozga koji postupno utječe na pamćenje, intelektualne sposobnosti i ponašanje.
English: The ink may or may not contain potassium hydroxide.
Croatian: Tinta može ili ne mora sadržavati kalijev hidroksid.
English: • if you have a skin reaction spreading beyond the patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve within 48 hours after removal of the transdermal patch.
Croatian: • ako imate kožnu reakciju koja se širi izvan područja pokrivenog flasterom, ako postoji intenzivnija lokalna reakcija (poput mjehurića, pojačane upale kože, oticanja) te ako se one ne povuku unutar 48 sati od uklanjanja transdermalnog flastera.
English: Clinical studies in dementia associated with Parkinson's disease The efficacy of rivastigmine in dementia associated with Parkinson's disease has been demonstrated in a 24-week multicentre, double-blind, placebo-controlled core study and its 24-week open-label extension phase.
Croatian: Klinička ispitivanja u demenciji povezanoj s Parkinsonovom bolešću Djelotvornost rivastigmina u demenciji povezanoj s Parkinsonovom bolešću pokazana je u 24-tjednom multicentričnom, dvostruko slijepom, placebo kontroliranom, osnovnom ispitivanju, te njegovoj 24tjednoj otvorenoj produženoj fazi.
English: - Blisters (Al/PVC): 28, 56 and 112 hard capsules.
Croatian: 6.5 Vrsta i sadržaj spremnika - Blisteri (Al/PVC): 28, 56 i 112 tvrdih kapsula.
English: Rivastigmine Actavis might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson's disease or to prevent travel sickness).
Croatian: Rivastigmin Actavis može utjecati na antikolinergičke lijekove (lijekove koji se koriste za ublažavanje grčeva ili spazama u želucu, za liječenje Parkinsonove bolesti ili za sprječavanje mučnine na putovanju).
English: Contents of the pack and other information What Rivastigmine Actavis contains - The active substance is rivastigmine hydrogen tartrate.
Croatian: Sadržaj pakiranja i druge informacije Što Rivastigmin Actavis sadrži - Djelatna tvar je rivastigminhidrogentartarat.
English: Possible dose adjustments or temporarily stopping treatment can be considered if needed.
Croatian: Ako je potrebno, mogu se razmotriti moguće prilagodbe doze ili privremeni prekid liječenja.
English: Rivastigmine Actavis should not be given at the same time as other medicines with similar effects to Rivastigmine Actavis.
Croatian: Rivastigmin Actavis se ne smije davati istodobno s drugim lijekovima sa sličnim djelovanjem Rivastigmin Actavisu.
English: • The highest dose that should be taken is 6 mg twice a day.
Croatian: • Najviša doza koju smijete uzimati je 6 mg dva puta na dan.
English: By blocking these enzymes, Rivastigmine Actavis allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.
Croatian: Blokiranjem tih enzima, Rivastigmin Actavis omogućava povećavanje koncentracije acetilkolina u mozgu te tako pomaže u smanjivanju simptoma Alzheimerove bolesti i demencije povezane s Parkinsonovom bolešću.
English: If you take more Rivastigmine Actavis than you should If you accidentally take more Rivastigmine Actavis than you should, inform your doctor.
Croatian: Ako slučajno uzmete više Rivastigmina Actavis nego biste trebali, obavijestite svog liječnika.
English: Caution when Rivastigmine Actavis is taken together with beta-blockers (medicines such as atenolol used to treat hypertension, angina and other heart conditions).
Croatian: Potreban je oprez kod uzimanja Rivastagmina Actavis zajedno s beta blokatorima (lijekovima kao što je atenolol koji se koristi za liječenje hipertenzije, angine i drugih srčanih stanja).
English: Rivastigmine Actavis should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting).
Croatian: Rivastigmine Actavis se ne smije davati istodobno s metoklopramidom (lijekom koji se koristi za ublažavanje ili sprječavanje mučnine i povraćanja).
English: Some people who have accidentally taken too much Rivastigmine Actavis have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations.
Croatian: Neki ljudi koji su slučajno uzeli previše Rivastigmina Actavis su osjećali mučninu, povraćali, imali proljev, visoki krvni tlak i halucinacije.
English: • Take Rivastigmine Actavis twice a day, in the morning and evening, with food.
Croatian: • Rivastigmin Actavis morate uzimati dvaput na dan, jednom uz doručak i jednom uz večeru.
English: Do not use this medicine after the expiry date which is stated on the carton, blister or capsule container after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, blisteru ili spremniku s kapsulama iza „Rok valjanosti/EXP“.
English: Clinically relevant improvement in these studies was defined a priori as at least 4-point improvement on the ADAS-Cog, improvement on the CIBIC-Plus, or at least a 10 % improvement on the PDS.
Croatian: Klinički značajno poboljšanje u ovim ispitivanjima definirano je prvenstveno kao poboljšanje od najmanje 4 boda na ADAS-Cog ljestvici, poboljšanje na CIBIC-Plus ili poboljšanje od najmanje 10 % na PDS ljestvici.
English: Inhibition of butyrylcholinesterase activity in CSF of 14 Alzheimer patients treated by rivastigmine was similar to that of AChE.
Croatian: Inhibicija aktivnosti butirilkolinesteraze u cerebrospinalnoj tekućini 14 bolesnika s Alzheimerovom bolešću, koji su bili liječeni rivastigminom, bila je slična inhibiciji aktivnosti AChEa.
English: No safety margins to human exposure were achieved in the animal studies due to the sensitivity of the animal models used.
Croatian: Zbog osjetljivosti korištenih životinjskih modela, u ispitivanjima na životinjama nisu postignute granice sigurnosti za izloženost lijeku kod ljudi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 June 2011
Croatian: Datum prvog odobrenja: 16. lipnja 2011.
English: NAME OF THE MARKETING AUTHORISATION HOLDER [Actavis logo]
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET [Actavis logo]
English: • if you have, or have ever had, irregular or slow heartbeat.
Croatian: • ako imate ili ste imali nepravilne ili spore otkucaje srca.
English: The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer's dementia treated with rivastigmine.
Croatian: Sljedeće nuspojave, navedene u Tablici 1, prikupljene su u bolesnika s Alzheimerovom demencijom liječenih rivastigminom.
English: • if you have, or have ever had, asthma or severe respiratory disease.
Croatian: • ako imate ili ste imali astmu ili tešku bolest dišnih puteva.
English: Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with rivastigmine in patients with dementia associated with Parkinson's disease with predefined adverse events that may reflect worsening of parkinsonian symptoms.
Croatian: Tablica 3 navodi broj i postotak bolesnika iz specifičnog kliničkog ispitivanja u trajanju od 24 tjedna, provedenog rivastigminom u bolesnika s demencijom povezanom s Parkinsonovom bolešću, pri čemu su nuspojave, koje bi mogle odražavati pogoršanje simptoma parkinsonizma, bile unaprijed definirane.
English: PHARMACEUTICAL FORM AND CONTENTS 250 hard capsules
Croatian: OBLIK I SADRŽAJ 250 tvrdih kapsula
English: Based on evidence from animal studies the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.
Croatian: Na temelju dokaza iz i ispitivanja na životinjama, u metabolizam rivastigmina minimalno su uključeni glavni izoenzimi citrokroma P450.
English: You should not breast-feed during treatment with Rivastigmine Actavis.
Croatian: Ne smijete dojiti tijekom liječenja Rivastigminom Actavis.
English: Table 2 shows the adverse reactions reported during clinical studies conducted in patients with dementia associated with Parkinson's disease treated with rivastigmine capsules.
Croatian: Tablica 2 pokazuje nuspojave zabilježene tijekom kliničkih ispitivanja provedenih u bolesnika s demencijom povezanom s Parkinsonovom bolešću, liječenih rivastigmin kapsulama.
English: • Tell your caregiver that you are taking Rivastigmine Actavis.
Croatian: • Recite osobi koja Vas njeguje da uzimate Rivastigmin Actavis.
English: The following additional adverse reactions have been observed with rivastigmine transdermal patches: delirium, pyrexia, decreased appetite, urinary incontinence (common), psychomotor hyperactivity (uncommon), erythema, urticaria, vesicles, allergic dermatitis (not known).
Croatian: Kod primjene rivastigmin transdermalnog flastera zabilježene su sljedeće dodatne nuspojave: delirij, pireksija, smanjeni apetit, inkontinencija mokraće (često), psihomotorička hiperaktivnost (manje često), eritem, urtikarija, vezikule, alergijski dermatitis (nepoznato).
English: Manufacturer Specifar S.A 1, 28 Octovriou str. 123 51 Ag. Varvara Athens
Croatian: Proizvođač Specifar S.A 1, 28 Octovriou str. 123 51 Ag.
English: The Cmax of rivastigmine was approximately 60 % higher and the AUC of rivastigmine was more than twice as high in subjects with mild to moderate hepatic impairment than in healthy subjects.
Croatian: Cmax rivastigmina bio je oko 60 % veći, a AUC rivastigmina bila je više nego dvostruko veća u ispitanika s blagim do umjerenim oštećenjem jetre, nego u zdravih ispitanika.
English: Rivastigmine Actavis may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose.
Croatian: Rivastigmin Actavis može uzrokovati omaglicu i izrazitu pospanost, pogotovo na početku liječenja ili prilikom povećanja doze.
English: The following additional adverse reaction has been observed in a study of patients with dementia associated with Parkinson's disease treated with rivastigmine transdermal patches: agitation (common).
Croatian: Sljedeća dodatna nuspojava zabilježena je u ispitivanju na bolesnicima s demencijom povezanom s Parkinsonovom bolešću, koji su liječeni rivastigmin transdermalnim flasterima: agitiranost (često).
English: Placebo of parkinsonian symptoms in patients with dementia n (%)
Croatian: Placebo odražavati pogoršanje simptoma parkinsonizma u n (%)
English: There is no relevant use of Rivastigmine Actavis in the paediatric population in the treatment of Alzheimer's disease.
Croatian: Nema relevantne primjene Rivastigmina Actavis u pedijatrijskoj populaciji u liječenju Alzheimerove bolesti.
English: 1.5 mg twice a day.
Croatian: Početna doza 1,5 mg dva puta na dan.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristic, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
English: • if you have, or have ever had, an active stomach ulcer.
Croatian: • ako imate ili ste imali aktivni čir želuca.
English: The active substance of Rivastigmine Actavis is rivastigmine.
Croatian: Djelatna tvar Rivastigmina Actavis je rivastigmin.
English: Capsule content: Magnesium stearate, colloidal anhydrous silica, hypromellose and microcrystalline cellulose.
Croatian: magnezijev stearat, koloidni bezvodni silicijev dioksid, hipromeloza i mikrokristalična celuloza.
English: Pre-defined adverse events that may reflect worsening Rivastigmine
Croatian: Unaprijed definirani štetni događaji koji mogu
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [Actavis logo]
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET [Actavis logo]
English: How to take Rivastigmine Actavis
Croatian: Kako uzimati Rivastigmin Actavis
English: There is no relevant use of rivastigmine in the paediatric population in the treatment of Alzheimer's disease.
Croatian: Pedijatrijska populacija Nema relevantne primjene rivastigmina u pedijatrijskoj populaciji u liječenju Alzheimerove bolesti.
English: If you are pregnant, the benefits of using Rivastigmine Actavis must be assessed against the possible effects on your unborn child. Rivastigmine Actavis should not be used during pregnancy, unless clearly necessary.
Croatian: Ako ste trudni, potrebno je ocijeniti koristi od uporabe Rivastigmin Actavis transdermalnih flastera u usporedbi s mogućim učincima na Vaše nerođeno dijete.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR CAPSULE CONTAINER
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA SPREMNIK S KAPSULAMA
English: • if you have, or have ever had, seizures.
Croatian: • ako imate ili ste imali napadaje.
English: 6-12 mg
Croatian: Rivastigmin 6-12 mg N=379
English: • if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea.
Croatian: • ako imate probavne reakcije poput osjećaja mučnine, povraćanje i proljeva.
English: Rivastigmine Actavis 1.5 mg hard capsules Rivastigmine Actavis 3 mg hard capsules Rivastigmine Actavis 4.5 mg hard capsules Rivastigmine Actavis 6 mg hard capsules rivastigmine
Croatian: Rivastigmin Actavis 1,5 mg tvrde kapsule Rivastigmin Actavis 3 mg tvrde kapsule Rivastigmin Actavis 4,5 mg tvrde kapsule Rivastigmin Actavis 6 mg tvrde kapsule rivastigmin
English: Rivastigmine Actavis 1.5 mg hard capsules Rivastigmine Actavis 3 mg hard capsules Rivastigmine Actavis 4.5 mg hard capsules Rivastigmine Actavis 6 mg hard capsules
Croatian: Rivastigmin Actavis 1,5 mg tvrde kapsule Rivastigmin Actavis 3 mg tvrde kapsule Rivastigmin Actavis 4,5 mg tvrde kapsule Rivastigmin Actavis 6 mg tvrde kapsule
English: UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR CAPSULE CONTAINER
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA ZA SPREMNIK S KAPSULAMA
English: • if you have, or have ever had impaired kidney function.
Croatian: • ako imate ili ste imali poremećaj funkcije bubrega.
English: What Rivastigmine Actavis looks like and contents of the pack - Rivastigmine Actavis 1.5 mg hard capsules, which contain off-white to slightly yellow powder, have a yellow cap and yellow body, with red imprint “RIV 1.5mg” on body.
Croatian: Kako Rivastigmin Actavis izgleda i sadržaj pakiranja - Rivastigmin Actavis 1,5 mg tvrde kapsule, sadrže bjelkasti do blago žuti prašak, imaju žutu kapicu i žuto tijelo, s crvenom oznakom „RIV 1.5mg“ na tijelu kapsule.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Actavis Group PTC ehf.
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Actavis Group PTC ehf.
English: Magnesium stearate Silica colloidal, anhydrous Hypromellose Microcrystalline cellulose
Croatian: Sadržaj kapsule: magnezijev stearat silicijev dioksid, koloidni, bezvodni hipromeloza celuloza, mikrokristalična
English: How to store Rivastigmine Actavis
Croatian: Kako čuvati Rivastigmin Actavis
English: België/Belgique/Belgien Actavis Group PTC ehf.
Croatian: België/Belgique/Belgien Actavis Group PTC ehf. IJsland / Islande / Island
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 sa složenim strojevima.
English: Each Rivastigmine Actavis 6 mg capsule contains 6 mg of rivastigmine.
Croatian: Jedna Rivastigmin Actavis 6 mg kapsula sadrži 6 mg rivastigmina.
English: Each Rivastigmine Actavis 1.5 mg capsule contains 1.5 mg of rivastigmine.
Croatian: Jedna Rivastigmin Actavis 1,5 mg kapsula sadrži 1,5 mg rivastigmina.
English: Muscle rigidity
Croatian: Mišićna rigidnost
English: INFORMATION IN BRAILLE Rivastigmine Actavis 4.5 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Rivastigmin Actavis 4,5 mg
English: Dosing recommendations to titrate according to individual tolerability must be closely followed.
Croatian: Moraju se strogo pratiti preporuke za titraciju u skladu s individualnom podnošljivošću.Bolesnici s teškim oštećenjem jetre nisu proučavani.
English: N=444
Croatian: Placebo N=444
English: Each Rivastigmine Actavis 4.5 mg capsule contains 4.5 mg of rivastigmine.
Croatian: Jedna Rivastigmin Actavis 4,5 mg kapsula sadrži 4,5 mg rivastigmina.
English: ITT + RDO population (n=87)
Croatian: Populacija ITT + RDO
English: Nightmares Agitation
Croatian: Noćne more
English: INFORMATION IN BRAILLE Rivastigmine Actavis 1.5 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Rivastigmin Actavis 1,5 mg
English: Each Rivastigmine Actavis 3 mg capsule contains 3 mg of rivastigmine.
Croatian: Jedna Rivastigmin Actavis 3 mg kapsula sadrži 3 mg rivastigmina.
English: Luxembourg/Luxemburg Actavis Group PTC ehf.
Croatian: Luxembourg/Luxemburg Actavis Group PTC ehf. Islande / Island
English: • if you have, or have ever had, impaired liver function.
Croatian: • ako imate ili ste imali poremećaj funkcije jetre.
English: Balance disorder Musculoskeletal stiffness Rigors
Croatian: Muskuloskeletna ukočenost
English: ITT: Intent-To-Treat; RDO: Retrieved Drop Outs
Croatian: ITT: (eng.Intent-To-Treat; namjera liječiti); RDO (eng.
English: Mean change at 24 weeks 2.1 ± 8.2 ± SD
Croatian: Početna srednja vrijednost ± SD Srednja promjena nakon 24 tjedna ± SD
English: INFORMATION IN BRAILLE Rivastigmine Actavis 6 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Rivastigmin Actavis 6 mg
English: (MMSE 18-24)
Croatian: Bolesnici s blagom demencijom (MMSE 18-24)
English: Rivastigmine Actavis 1.5 mg hard capsules Titanium dioxide (E171) Yellow iron oxide (E172) Gelatine
Croatian: Rivastigmine Actavis 1,5 mg tvrde kapsule titanijev dioksid (E171) željezov oksid, žuti (E172) želatina
English: Rivastigmine Actavis 3 mg, 4.5 mg and 6 mg hard capsules: Red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172) and gelatine.
Croatian: Rivastigmine Actavis 3 mg, 4,5 mg i 6 mg tvrde kapsule: crveni željezov oksid (E172), titanijev dioksid (E171), žuti željezov oksid (E172) i želatina Tinta za označavanje: šelak, propilenglikol, crveni željezov oksid (E172).
English: The patients studied 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: INFORMATION IN BRAILLE Rivastigmine Actavis 3 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Rivastigmin Actavis 3 mg
English: - Rivastigmine Actavis 4.5 mg hard capsules, which contain off-white to slightly yellow powder, have a red cap and red body, with white imprint “RIV 4.5mg” on body.
Croatian: - Rivastigmin Actavis 4,5 mg tvrde kapsule, sadrže bjelkasti do blago žuti prašak, imaju crvenu kapicu i crveno tijelo, s bijelom oznakom „RIV 4.5mg“ na tijelu kapsule.
English: Red iron oxide (E172)
Croatian: žuti željezov oksid (E172) i želatina.
English: Deutschland Actavis Group PTC ehf.
Croatian: Deutschland Actavis Group PTC ehf. Island
English: Rivastigmine Actavis 4.5 mg hard capsules
Croatian: Rivastigmin Actavis 4,5 mg tvrde kapsule
English: Anxiety
Croatian: Agitacija
English: Rivastigmine Actavis 1.5 mg hard capsules
Croatian: Rivastigmin Actavis 1,5 mg tvrde kapsule
English: N=472
Croatian: Placebo N=472
English: Rivastigmine Actavis 6 mg hard capsules
Croatian: Rivastigmin Actavis 6 mg tvrde kapsule
English: Rivastigmine Actavis 6 mg hard capsules EU/1/11/693/013
Croatian: Rivastigmine Actavis 6 mg tvrde kapsule EU/1/11/693/013
English: Rivastigmine Actavis 3 mg hard capsules
Croatian: Rivastigmin Actavis 3 mg tvrde kapsule
English: Marketing Authorisation Holder Actavis Group PTC ehf.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Actavis Group PTC ehf.
English: Off-white to slightly yellow powder in a hard capsule with yellow cap and yellow body, with red imprint “RIV 1.5mg” on body.
Croatian: Bjelkasti do blago žuti prašak u tvrdoj kapsuli sa žutom kapicom i žutim tijelom, s crvenom oznakom „RIV 1.5mg“ na tijelu kapsule.
English: - Rivastigmine Actavis 6 mg hard capsules, which contain off -white to slightly yellow powder, have an red cap and orange body, with red imprint “RIV 6mg” on body.
Croatian: - Rivastigmin Actavis 6 mg tvrde kapsule, sadrže bjelkasti do blago žuti prašak, imaju crvenu kapicu i narančasto tijelo, s crvenom oznakom „RIV 6mg“ na tijelu kapsule.
English: Off-white to slightly yellow powder in a hard capsule with red cap and red body, with white imprint “RIV 4.5mg” on body.
Croatian: Bjelkasti do blago žuti prašak u tvrdoj kapsuli s crvenom kapicom i crvenim tijelom, s bijelom oznakom „RIV 4.5mg“ na tijelu kapsule.
English: Reykjavíkurvegur 76 - 78 IS-220 Hafnarfjördur Iceland
Croatian: Reykjavíkurvegur 76 - 78 IS-220 Hafnarfjördur Island
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: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/016
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/693/016
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 4.5 mg rivastigmine (as hydrogen tartrate).
Croatian: TVARI 1 kapsula sadrži 4,5 mg rivastigmina (u obliku rivastagminhidrogentartarata).
English: - Rivastigmine Actavis 3 mg hard capsules, which contain off-white to slightly yellow powder, have an orange cap and orange body, with red imprint “RIV 3mg” on body.
Croatian: - Rivastigmin Actavis 3 mg tvrde kapsule, sadrže bjelkasti do blago žuti prašak, imaju narančastu kapicu i narančasto tijelo, s crvenom oznakom „RIV 3mg“ na tijelu kapsule.