natgillin/translations-raw huggingface dataset:
Magnesium stearate Hypromellose Microcrystalline cellulose Silica, colloidal anhydrous Yellow iron oxide (E172) Red iron oxide (E172) Titanium dioxide (E171) Shellac
6.1 Popis pomoćnih tvari želatina magnezijev stearat hipromeloza celuloza, mikrokristalična silicijev dioksid, koloidni, bezvodni željezov oksid, žuti (E172) željezov oksid, crveni (E172) titanijev dioksid (E171) šelak
How to apply your Prometax transdermal patch Prometax patches are thin, opaque, plastic patches that stick to the skin.
Prometax flasteri su tanki, neprozirni, plastični flasteri koji se lijepe na kožu.
Alzheimer's disease may cause gradual impairment of driving performance or compromise the ability to use machines.
Alzheimerova bolest može postupno smanjiti sposobnost upravljanja vozilima ili narušiti sposobnost rada na strojevima.
• Fainting or accidentally falling
• Nesvjestica ili nehotično padanje
Benzoic acid is a mild irritant to the skin, eyes and mucous membranes.
Benzojeva kiselina je blagi iritans kože, očiju i sluznica.
Urinary tract infection Metabolism and nutrition disorders Common
Infekcija urinarnog trakta Poremećaji metabolizma i prehrane Često
Prometax oral solution should be used within 1 month of opening the bottle.
Prometax oralna otopina treba se primijeniti unutar mjesec dana od prvog otvaranja bočice.
In patients with Alzheimer's disease, inhibition of AChE in CSF by rivastigmine was dose-dependent up to 6 mg given twice daily, the highest dose tested.
U bolesnika s Alzheimerovom bolešću, inhibicija AChE u cerebrospinalnoj tekućini rivastigminom bila je ovisna o dozi sve do 6 mg dva puta na dan, što je bila najviša ispitivana doza.
However, a greater treatment effect was seen in Parkinson's disease patients with moderate dementia.
No, veći terapijski učinak uočen je u bolesnika s Parkinsonovom bolešću i umjerenom demencijom.
If you stop using Prometax Tell your doctor or pharmacist if you stop using the patch.
Obratite se svom liječniku ili ljekarniku ako prestanete koristiti flaster.
- HDPE bottles with plastic closure with induction innerseal.
- HDPE boce s plastičnim zatvaračem sa zaštitnom folijom.
56 hard capsules
56 tvrdih kapsula
7 transdermal patches 30 transdermal patches
7 transdermalnih flastera 30 transdermalnih flastera
• Stomach ulcer
Ulkus želuca
Care must be taken when prescribing Prometax transdermal patches:
Potreban je oprez kod propisivanja Prometax transdermalnih flastera:
In patients with Alzheimer's disease, inhibition of AChE in CSF by oral rivastigmine was dose-dependent up to 6 mg given twice daily, the highest dose tested.
U bolesnika s Alzheimerovom bolešću inhibicija AChE u cerebrospinalnoj tekućini oralnim rivastigminom bila je ovisna o dozi sve do 6 mg dva puta na dan, što je bila najviša ispitivana doza.
• Difficulty in sleeping
• Poteškoće sa snom
There have been rare post-marketing reports of patients experiencing allergic dermatitis (disseminated) when administered rivastigmine irrespective of the route of administration (oral, transdermal).
Postojala su rijetka iskustva s alergijskim dermatitisom (diseminiranim) u bolesnika nakon stavljanja lijeka u promet kod primjene rivastigmina, bez obzira na put primjene (peroralno, transdermalno).
Particular caution must be exercised in titrating these patients (see sections 4.2 and 5.2).
Potreban je poseban oprez kod titriranja doze u tih bolesnika (vidjeti dijelove 4.2 i 5.2).
• Feeling agitated or sleepy
• Osjećaj nemira ili pospanosti
What Prometax contains - The active substance is rivastigmine hydrogen tartrate.
Što Prometax sadrži - Djelatna tvar je rivastigminhidrogentartarat.
• to patients with a history of asthma or obstructive pulmonary disease.
• u bolesnika koji u anamnezi imaju astmu ili opstruktivnu bolest pluća.
28 hard capsules
28 tvrdih kapsula
Gastrointestinal disorders such as nausea, vomiting and diarrhoea are dose-related, and may occur particularly when initiating treatment and/or increasing the dose (see section 4.8).
Gastrointestinalni poremećaji poput mučnine, povraćanja i proljeva, ovisni su o dozi, te se mogu javiti osobito kod početka liječenja i/ili povećavanja doze (vidjeti dio 4.8).
To prevent interference with the adhesive properties of the transdermal patch, no cream, lotion or powder should be applied to the skin area where the medicinal product is to be applied.
Radi sprečavanja ometanja ljepljivih svojstava transdermalnog flastera, na površinu kože na koju će se primijeniti lijek ne smije se nanositi krema, losion ili puder.
Rivastigmine oral solution should be administered twice a day, with morning and evening meals.
Rivastigmin oralnu otopinu treba primjenjivati dvaput na dan, uz doručak i večeru.
Particular caution should be exercised in titrating these patients (see sections 4.4 and 5.2).
Potreban je poseban oprez kod titriranja doze u tih bolesnika (vidjeti dijelove 4.4 and 5.2).
How to take Prometax
Kako uzimati Prometax
You should not breast-feed during treatment with Prometax transdermal patches.
Ne smijete dojiti tijekom liječenja Prometax transdermalnim flasterima.
Also contains: polyethylene terephthalate film lacquered, alpha-tocopherol, poly(butylmethacrylate, methylmethacrylate), acrylic copolymer, silicone oil, dimethicone, polyester film fluoropolymercoated.
Također sadrži: polietilentereftalatni film lakirani, alfa-tokoferol, poli(butilmetakrilat, metilmetakrilat), akrilni kopolimer, silikonsko ulje, dimetikon, poliesterski film obložen fluoropolimerom.
- Blister of clear PVC tray with blue lidding foil with 14 capsules.
6.5 Vrsta i sadržaj spremnika - Blister od prozirne PVC podloge i plave pokrovne folije s 14 kapsula.
Removing bubbles
Uklanjanje mjehurića
Inhibition of butyrylcholinesterase activity in CSF of 14 Alzheimer patients treated by oral rivastigmine was similar to the inhibition of AChE activity.
Inhibicija aktivnosti butirilkolinesteraze u cerebrospinalnoj tekućini 14 bolesnika s Alzheimerovom bolešću, koji su bili liječeni rivastigminombila je slična inhibiciji aktivnosti AChE -a.
Medicinal product matrix
Matriks s lijekom
Allergic dermatitis (disseminated) General disorders and administration site conditions Very common
Alergijski dermatitis (diseminirani) Opći poremećaji i reakcije na mjestu primjene Vrlo često
Prometax should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting).
Prometax se ne smije davati istodobno s metoklopramidom (lijekom koji se koristi za ublažavanje ili sprječavanje mučnine i povraćanja).
• Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea
• Želučani problemi poput osjećaja mučnine ili povraćanja, proljev
• Stiff arms or legs
• Ukočenost ruku ili nogu
Metabolism and nutrition disorders Very common
Poremećaji metabolizma i prehrane Vrlo često
ITT + RDO population (n=87)
Populacija ITT + RDO (n=87)
Rare (may affect up to 1 in 1,000 people) • Falling
Rijetko (mogu se javiti u do 1 na 1000 ljudi) • Nehotično padanje
If you are pregnant, the benefits of using Prometax must be assessed against the possible effects on your unborn child. Prometax should not be used during pregnancy unless clearly necessary.
Ako ste trudni, potrebno je ocijeniti koristi od uporabe Prometax transdermalnih flastera u usporedbi s mogućim učincima na Vaše nerođeno dijete.
Other side effects seen with Prometax capsules or oral solution and which may occur with the patch:
Ostale nuspojave zabilježene uz primjenu Prometax kapsula ili oralne otopine, a koje se mogu pojaviti s flasterima:
The efficacy of Prometax transdermal patches in patients with Alzheimer's dementia has been demonstrated in a 24-week double-blind, placebo-controlled core study and its open-label extension phase and in a 48-week double-blind comparator study.
Djelotvornost Prometax transdermalnih flastera u bolesnika s Alzheimerovom demencijom dokazana je u 24-tjednom dvostruko slijepom, placebom kontroliranom osnovnom ispitivanju i u njegovom otvorenom produžetku te u 48-tjednom dvostruko slijepom ispitivanju s komparatorom.
Clinically relevant improvement was defined a priori as at least 4-point improvement on the ADAS-Cog, no worsening on the ADCS-CGIC, and no worsening on the ADCS-ADL.
Klinički značajno poboljšanje definirano je unaprijed kao poboljšanje od najmanje 4 boda na ADAS-Cog-u, izostanak pogoršanja na ADCS-CGIC-u, te izostanak pogoršanja na ADCS-ADL-u.
- if you have, or have ever had impaired kidney function.
- ako imate ili ste imali poremećaj funkcije bubrega.
112 hard capsules
112 tvrdih kapsula
Prometax Patch should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting).
Prometax flaster se ne smije davati istodobno s metoklopramidom (lijekom koji se koristi za ublažavanje ili sprječavanje mučnine i povraćanja).
Administration of rivastigmine oral solution with food delays absorption (tmax) by 74 min and lowers Cmax by 43% and increases AUC by approximately
Primjena oralne otopine s hranom odgađa apsorpciju (tmax) za 74 minuta te snižava Cmax za 43% i povećava AUC za otprilike 9%.
FOLDING BOX AND BOTTLE LABEL
NALJEPNICA ZA KUTIJU I BOCU
• Accidental falls
• Slučajni padovi
The results for clinically relevant responders pooled from two flexible dose studies out of the three pivotal 26-week multicentre studies in patients with mild-to-moderately severe Alzheimer's Dementia, are provided in Table 4 below.
U Tablici 4 ispod su prikazani rezultati bolesnika s klinički relevantnim odgovorom, iz udruženih rezultata dva ispitivanja s fleksibilnom dozom, od tri osnovna 26-tjedna multicentrična ispitivanja u bolesnika s blagom do umjereno teškom Alzheimerovom demencijom.
- The other ingredients are polyethylene terephthalate film lacquered, alpha-tocopherol, poly(butylmethacrylate, methylmethacrylate), acrylic copolymer, silicone oil, dimethicone, polyester film fluoropolymer-coated.
- Drugi sastojci su polietilentereftalatni film lakirani, alfa-tokoferol, poli(butilmetakrilat, metilmetakrilat), akrilni kopolimer, silikonsko ulje, dimetikon, poliesterski film obložen fluoropolimerom.
Prometax transdermal patches 9.5 mg/24 h N = 251
Prometax Transdermalni flasteri 9,5 mg/24 h N=251
Otherwise your doctor will restart your treatment on Prometax 4.6 mg/24 h.
U suprotnom, liječnik će ponovno započeti Vaše liječenje Prometaxom 4,6 mg/24 h.
Benzoic acid is a mild irritant to the skin, eyes and mucous membrane.
Benzoatna kiselina je blago nadražuje kožu, oči i sluznice.
• Urinary tract infection
Infekcija urinarnog trakta
Prometax 1.5 mg hard capsules Prometax 3.0 mg hard capsules Prometax 4.5 mg hard capsules Prometax 6.0 mg hard capsules
Prometax 1,5 mg tvrde kapsule Prometax 3,0 mg tvrde kapsule Prometax 4,5 mg tvrde kapsule Prometax 6,0 mg tvrde kapsule
colloidal anhydrous silica, gelatin, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171) and shellac.
- Drugi sastojci su: hipromeloza, magnezijev stearat, mikrokristalična celuloza, koloidni bezvodni silicijev dioksid, želatina, žuti željezov oksid(E172), crveni željezov oksid (E172), titanijev dioksid (E171) i šelak.
These include the ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, a performance-based measure of cognition) and the ADCS-CGIC (Alzheimer's Disease Cooperative Study - Clinician's Global Impression of Change, a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the ADCS-ADL (Alzheimer's Disease Cooperative StudyActivities of Daily Living, a caregiver-rated assessment of the activities of daily living including personal hygiene, feeding, dressing, household chores such as shopping, retention of ability to orient oneself to surroundings as well as involvement in activities related to finances).
Alzheimer's Disease Assessment Scale -kognitivna podljestvica, mjerilo kognitivne sposobnosti koje se temelji na izvedbi) i ADCS-CGIC (sveobuhvatna globalna procjena bolesnika od strane liječnika koja uključuje podatke dobivene od njegovatelja), te ADCS-ADL (njegovateljeva procjena svakodnevnih aktivnosti, uključujući osobnu higijenu, hranjenje, oblačenje, poslove vezane za domaćinstvo kao što su odlazak u kupovinu, očuvanje sposobnosti orijentiranja u okolini, kao i uključivanje u aktivnosti koje se odnose na financije).
ITT + RDO population (n=329)
Populacija ITT + RDO (n=329)
The prescribed amount of solution should be withdrawn from the container using the oral dosing syringe supplied.
Propisanu količinu otopine treba uzeti iz spremnika pomoću priložene dozirne štrcaljke za peroralnu primjenu.
• Keep the transdermal patch in the sachet until use.
• Čuvati transdermalni flaster u vrećici sve do primjene.
There is no relevant use of Prometax in the paediatric population in the treatment of Alzheimer's disease.
Nema relevantne primjene Prometaxa u pedijatrijskoj populaciji u liječenju Alzheimerove bolesti.
Transdermal patch Novartis Pharma GmbH Roonstraße 25
Transdermalni flaster Novartis Pharma GmbH Roonstraße 25
• Push the nozzle of the syringe into the hole in the white stopper.
• Umetnite vrh štrcaljke u bijeli čep utisnut u grlo boce.
• Feeling tired or weak
• Osjećaj umora ili slabosti
Each ml contains 2 mg rivastigmine present as rivastigmine hydrogen tartrate.
Svaki ml sadrži 2 mg rivastigmina u obliku rivastigminhidrogentartarata.
The 24-week results for the three assessment tools are summarised in Table 2.
Rezultati nakon 24 tjedna za tri ocjenske skale sažeti su u Tablici 2.
What Prometax looks like and contents of the pack - Prometax 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with red imprint “ENA 713 1,5 mg” on the body.
Kako Prometax izgleda i sadržaj pakiranja - Prometax 1,5 mg tvrde kapsule, sadrže bjelkasti do blago žuti prašak, imaju žutu kapicu i žuto tijelo, s crvenom oznakom „ENA 713 1,5 mg“ na tijelu kapsule.
What Prometax looks like and contents of the pack Prometax oral solution is supplied as 50 ml or 120 ml of a clear, yellow solution (2.0 mg/ml base) in an amber glass bottle with a child-resistant cap, foam liner, dip tube and self aligning plug.
Prometax oralna otopina isporučuje se kao 50 ml ili 120 ml bistre, žute otopine (2,0 mg/ml baze) u smeđoj staklenoj boci sa sigurnosnim zatvaračem za djecu, pjenastom oblogom, umetnutom cjevčicom i čepom utisnutim u grlo boce.
Very rare (may affect up to 1 in 10,000 people)
Vrlo rijetko (mogu se javiti u do 1 na 10 000 ljudi)
The outside of the backing layer is beige and labelled with “Prometax”, “4.6 mg/24 h” and “AMCX”.
Vanjski dio potpornog sloja je bež boje s oznakama „Prometax“, „4.6 mg/24 h“ i „AMCX“.
Rivastigmine oral solution may be swallowed directly from the syringe.
Rivastigmin oralna otopina može se uštrcati izravno u usta i progutati.
• Do not store above 25°C.
• Ne čuvati na temperaturi iznad 25°C.
Vascular disorders Not known
Krvožilni poremećaji Nepoznato
Very common (may affect more than 1 in 10 people)
Vrlo često (mogu se javiti u više od 1 na 10 ljudi)
After oral administration, 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.
Nakon oralne primjene, 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.
• Push down and pull up the plunger a few times to get rid of any large bubbles.
• Izbacite sve velike mjehuriće istiskivanjem otopine i ponovnim izvlačenjem klipa štrcaljke nekoliko puta.
Prometax 1.5 mg hard capsules Prometax 3.0 mg hard capsules Prometax 4.5 mg hard capsules Prometax 6.0 mg hard capsules rivastigmine
Prometax 1,5 mg tvrde kapsule Prometax 3,0 mg tvrde kapsule Prometax 4,5 mg tvrde kapsule Prometax 6,0 mg tvrde kapsule rivastigmin
• Carefully remove any existing patch before putting on a new one.
• Pažljivo uklonite postojeći flaster (ako ga imate) prije stavljanja novoga.
ITT + RDO population (n=107)
Populacija ITT + RDO (n=107)
Taking your medicine
Uzimanje lijeka
Caution when Prometax is taken together with beta-blockers (medicines such as atenolol used to treat hypertension, angina and other heart conditions).
Potreban je oprez kod uzimanja Prometaxa zajedno s beta blokatorima (lijekovima kao što je atenolol koji se koristi za liječenje hipertenzije, angine i drugih srčanih stanja).
Adjusted treatment difference n/a p-value versus placebo
Prilagođena razlika u liječenju n/p p-vrijednost u odnosu na placebo
Application site skin reactions (e.g. application site erythema*, application site pruritus*, application site oedema*, application site dermatitis, application site irritation), asthenic conditions (e.g. fatigue, asthenia), pyrexia, weight decreased
Kožne reakcije na mjestu primjene (npr. eritem na mjestu primjene*, pruritus na mjestu primjene*, edem na mjestu primjene*, dermatitis na mjestu primjene, nadražaj na mjestu primjene), astenična stanja (e.g. umor i astenija), pireksija, gubitak tjelesne težine
Parkinson's disease (worsening) Salivary hypersecretion Dyskinesia
Parkinsonova bolest (pogoršanje) Prekomjerno lučenje sline
1 transdermal patch of 5 cm contains 9 mg rivastigmine and delivers 4.6 mg/24 h.
1 transdermalni flaster površine 5 cm sadrži 9 mg rivastigmina i oslobađa 4,6 mg/24 h.
Caution when Prometax Patch is given together with beta-blockers (medicines such as atenolol used to treat hypertension, angina, and other heart conditions).
Potreban je oprez kod uzimanja Prometax flastera zajedno s beta blokatorima (lijekovima kao što je atenolol koji se koristi za liječenje hipertenzije, angine i drugih srčanih stanja).
• Changes in how well your liver is working
• Promjene u normalnom radu jetre
• Treatment usually starts with Prometax 4.6 mg/24 h.
• Liječenje obično počinje Prometaxom 4,6 mg/24 h.
Prometax 13.3 mg/24 h transdermal patches: Each patch releasing 13.3 mg of rivastigmine per 24 hours is 15 cm and contains 27 mg of rivastigmine.
Prometax 13,3 mg/24 h transdermalni flasteri: Svaki flaster koji oslobađa 13,3 mg rivastigmina tijekom 24 sata ima površinu 15 cm i sadrži 27 mg rivastigmina.
Keep the transdermal patch in the sachet until use.
Čuvati transdermalni flaster u vrećici sve do primjene.
1 transdermal patch of 15 cm contains 27 mg rivastigmine and delivers 13.3 mg/24 h.
1 transdermalni flaster površine 15 cm2 sadrži 27 mg rivastigmina i oslobađa 13,3 mg/24 h.
• Inflammation of the pancreas - the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)
• Upala gušterače - znakovi uključuju ozbiljnu bol u gornjem dijelu trbuha, često s osjećajem mučnine ili povraćanjem
Therefore, in patients with dementia treated with rivastigmine, the ability to continue driving or operating complex machines should be routinely evaluated by the treating physician.
Zbog toga u bolesnika s demencijom, koji se liječe rivastigminom, liječnik treba rutinski procjenjivati mogu li nastaviti upravljati vozilima ili raditi na složenim strojevima.
Each transdermal patch of 15 cm contains 27 mg of rivastigmine.
Svaki transdermalni flaster površine 15 cm sadrži 27 mg rivastigmina.
Each transdermal patch releases 4.6 mg of rivastigmine per 24 hours.
Svaki transdermalni flaster oslobađa 4,6 mg rivastigmina u 24 sata.
Each Prometax 6.0 mg capsule contains 6.0 mg of rivastigmine.
Svaka Prometax 6,0 mg kapsula sadrži 6,0 mg rivastigmina.
1 transdermal patch of 10 cm contains 18 mg rivastigmine and delivers 9.5 mg/24 h.
1 transdermalni flaster površine 10 cm2 sadrži 18 mg rivastigmina i oslobađa 9,5 mg/24 h.
If adverse reactions (e.g. nausea, vomiting, abdominal pain or loss of appetite), weight decrease or worsening of extrapyramidal symptoms (e.g. tremor) in patients with dementia associated with Parkinson's disease are observed during treatment, these may respond to omitting one or more doses.
Ako se u bolesnika s demencijom koja je povezana s Parkinsonovom bolešću tijekom liječenja uoče nuspojave (npr. mučnina, povraćanje, abdominalna bol ili gubitak teka), smanjenje tjelesne težine ili pogoršanje ekstrapiramidnih simptoma (npr. tremora), oni se mogu izbjeći izostavljanjem jedne ili više doza.
Bradykinesia
Bradikinezija
• Swallow the capsules whole with a drink.
• Kapsule progutajte cijele uz tekućinu.
Nightmares
Noćne more
In pregnant animals, rivastigmine and /or metabolites crossed the placenta.
Rivastigmin i/ili metaboliti prelaze posteljicu u gravidnih životinja.
Each transdermal patch of 10 cm contains 18 mg of rivastigmine.
Svaki transdermalni flaster površine 10 cm sadrži 18 mg rivastigmina.
Each Prometax 1.5 mg capsule contains 1.5 mg of rivastigmine.
Svaka Prometax 1,5 mg kapsula sadrži 1,5 mg rivastigmina.
Fall
Pad
• Push down and turn the child resistant cap to open bottle.
• Kako biste otvorili bocu, sigurnosni zatvarač za djecu stisnite prema dolje i zakrenite.
No study was conducted with Prometax transdermal patches in subjects with hepatic impairment.
Nije provedeno nikakvo ispitivnaje s Prometax transdermalnim flasterima u ispitanika s oštećenjem jetre.
You should not breast-feed during treatment with Prometax.
Ne smijete dojiti tijekom liječenja Prometaxom.
• Renal impairment: No dose adjustment is necessary for patients with renal impairment (see section 5.2).
• Oštećenje bubrega: U bolesnika s blagim do umjerenim oštećenjem bubrega (vidjeti dio 5.2).
Each transdermal patch of 5 cm contains 9 mg of rivastigmine.
Svaki transdermalni flaster površine 5 cm sadrži 9 mg rivastigmina.
Each transdermal patch releases 9.5 mg of rivastigmine per 24 hours.
Svaki transdermalni flaster oslobađa 9,5 mg rivastigmina u 24 sata.
How to remove your Prometax transdermal patch Gently pull at one edge of the patch to remove it slowly from the skin.
Lagano povucite jedan kraj flastera kako biste ga polako skinuli s kože.
- 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.
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.
The outside of the backing layer is beige and labelled with “Prometax”, “13.3 mg/24 h” and “CNFU”.
Vanjski dio potpornog sloja je bež boje s oznakama „Prometax“, „13.3 mg/24 h“ i „CNFU“.
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.
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.
Each Prometax 3.0 mg capsule contains 3.0 mg of rivastigmine.
Svaka Prometax 3,0 mg kapsula sadrži 3,0 mg rivastigmina.
- 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.
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.
What Prometax contains - The active substance is rivastigmine.
Sadržaj pakiranja i druge informacije Što Prometax sadrži - Djelatna tvar je rivastigmin.
Rare (may affect up to 1 in 1,000 people)
Rijetko (mogu se javiti u do 1 na 1000 ljudi)
Where to apply your Prometax transdermal patch
Gdje treba postaviti Prometax transdermalni flaster
LOCF - Last Observation Carried Forward.
Zadnje zapažanje preneseno dalje (LOCF)
Each transdermal patch releases 13.3 mg of rivastigmine per 24 hours.
Svaki transdermalni flaster oslobađa 13,3 mg rivastigmina u 24 sata.
Polyester film, fluoropolymer-coated
Zaštitni sloj Poliesterski film, obložen fluoropolimerom.
Each Prometax 4.5 mg capsule contains 4.5 mg of rivastigmine.
Svaka Prometax 4,5 mg kapsula sadrži 4,5 mg rivastigmina.
Prometax 2 mg/ml oral solution
Prometax 2 mg/ml oralna otopina
1 transdermal patch per sachet
1 transdermalni flaster po vrećici
Oral solution Novartis Pharma GmbH Roonstraße 25
Oralna otopina Novartis Pharma GmbH Roonstraße 25