natgillin/translations-raw huggingface dataset:
The overall incidence of adverse events (AEs) in patients treated with Prometax 9.5 mg/ 24 h transdermal patches was lower than the rate in patients who received 3 to 12 mg/ day Prometax capsule treatment (50.5% with Prometax 9.5 mg/ 24 h transdermal patches vs 63.3% with Prometax capsules; 46.0% of patients on placebo reported AEs).
Pri bolnikih, zdravljenih s transdermalnimi obliži Prometax 9, 5 mg/ 24 h, je bila skupna incidenca neželenih dogodkov nižja kot pri bolnikih, ki so prejemali Prometax v kapsulah v odmerku 3 do 12 mg/ dan (50, 5% s transdermalnimi obliži Prometax 9, 5 mg/ 24 h v primerjavi s 63, 3% s kapsulami Prometax; pri tem je 46, 0% bolnikov s placebom poročalo o neželenih učinkih).
Gastrointestinal adverse reactions, including nausea and vomiting, were the most common adverse reactions in patients who received active treatment, and occurred at a substantially lower rate in the Prometax 9.5 mg/ 24 h transdermal patch group compared to the Prometax capsule group (7.2% vs 23.1% for nausea and 6.2% vs 17.0% for vomiting; 5.0% and 3.3% of patients on placebo reported nausea and vomiting, respectively).
Pri bolnikih, ki so prejemali aktivno zdravljenje, so bili med neželenimi učinki najpogostejši gastrointestinalni, vključno z navzeo in bruhanjem, pojavljali pa so se v precej manjši meri v skupini s transdermalnimi obliži Prometax 9, 5 mg/ 24 h v primerjavi s skupino s kapsulami Prometax (navzea v 7, 2% v primerjavi s 23, 1% in bruhanje v 6, 2% v primerjavi s 17, 0%; pri tem je 5, 0% bolnikov s placebom poročalo o navzei, 3, 3% pa o bruhanju).
Table 1 displays the adverse reactions (events reasonably believed to be causally related to the medicinal product) reported in 291 patients with Alzheimer’ s dementia treated in a specific 24-week double-blind, placebo and active-controlled clinical study with Prometax transdermal patches at target dose of 9.5 mg/ 24 h (4.6 mg/ 24 h titrated to 9.5 mg/ 24 h).
V preglednici 1 so navedeni neželeni učinki (dogodki, za katere upravičeno velja, da so vzročno povezani z zdravilom), o katerih so poročali pri 291 bolnikih z Alzheimerjevo demenco, zdravljenih v okviru specifične 24- tedenske dvojno slepe, s placebom in aktivno kontrolirane klinične študije s transdermalnimi obliži Prometax, v kateri je bil ciljni odmerek 9, 5 mg/ 24 h (titracija z odmerka 4, 6 mg/ 24 h na 9, 5 mg/ 24 h).
Common
pogosti:
Cardiac disorders
glavobol, sinkopa ekstrapiramidni simptomi bradikardija
Bradycardia
Bolezni prebavil
General disorders and administration site conditions
61 Splošne težave in spremembe na mestu aplikacije
60 When doses higher than 9.5 mg/ 24 h were used in the above-mentioned study, dizziness, insomnia, agitation, decreased appetite, atrial fibrillation and cardiac failure were observed more frequently than with 9.5 mg/ 24 h or placebo, suggesting a dose effect relationship.
Kadar so v zgoraj navedeni študiji uporabljali odmerke, ki so bili višji od 9, 5 mg/ 24 h, so opažali vrtoglavost, nespečnost, agitiranost, izgubo teka, atrijsko fibrilacijo in popuščanje srca pogosteje kot pri odmerku 9, 5 mg/ 24 h ali pri placebu, kar nakazuje odvisnost od velikosti odmerka.
However, these events did not occur at a higher frequency with Prometax 9.5 mg/ 24 h transdermal patches than with placebo.
Vendar pa se ti dogodki niso pojavljali pogosteje pri uporabi transdermalnega obliža Prometax 9, 5 mg/ 24 h v primerjavi s placebom.
Dizziness (very common); agitation, somnolence, malaise, tremor, confusion, sweating increased (common); insomnia, accidental fall, elevated liver function tests (uncommon); seizures, duodenal ulcers, angina pectoris (rare); cardiac arrhythmia (e. g. atrio-ventricular block, atrial fibrillation and tachycardia), hypertension, pancreatitis, gastrointestinal haemorrhage, hallucination (very rare); and some cases of severe vomiting were associated with oesophageal rupture (unknown).
Naslednje neželene učinke so opažali samo pri uporabi kapsul in peroralne raztopine Prometax, ne pa v kliničnih študijah s transdermalnimi obliži Prometax 9, 5 mg/ 24 h: vrtoglavost (zelo pogosto); agitacijo, somnolenco, splošno slabo počutje, tremor, zmedenost, povečano potenje (pogosto); nespečnost, nezgodne padce, zvišane jetrne funkcijske teste (občasno); napade krčev, razjede dvanajstnika, angino pektoris (redko); srčne aritmije (na primer atrioventrikularni blok, atrijsko fibrilacijo in tahikardijo), hipertenzijo, pankreatitis, krvavitev v prebavila, halucinacije (zelo redko); in nekaj primerov hudega bruhanja, ki je bilo povezano z rupturo požiralnika (pogostnost ni znana).
In a 24-week double-blind study, the most commonly observed symptoms (skin irritation rating scale) with Prometax 9.5 mg/ 24 h transdermal patches were very slight (21.8%), mild (12.5%) or moderate (6.5%) erythema or very slight (11.9%), mild (7.3%) or moderate (5.0%) pruritus.
V 24- tedenski dvojno slepi študiji so bili najbolj pogosto opaženi simptomi (po lestvici ocene draženja kože) s transdermalnimi obliži Prometax 9, 5 mg/ 24 h zelo blaga (21, 8%), blaga (12, 5%) ali zmerna (6, 5%) rdečina ali zelo blago (11, 9%), blago (7, 3%) ali zmerno (5, 0%) srbenje.
The most commonly observed severe symptoms with Prometax 9.5 mg/ 24 h transdermal patches were pruritus (1.7%) and erythema (1.1%).
Najpogosteje opažena huda simptoma s transdermalnimi obliži Prometax 9, 5 mg/ 24 h sta bila srbenje (1, 7%) in rdečina (1, 1%).
Most skin reactions were limited to the application site and resulted in discontinuation in only 2.4% of the patients in the Prometax 9.5 mg/ 24 h transdermal patch group.
Zaradi kožnih reakcij je zdravljenje prekinilo le 2, 4% bolnikov v skupini s transdermalnimi obliži Prometax 9, 5 mg/ 24 h.
There are currently no data on overdose with Prometax transdermal patches.
O prekomernem odmerjanju s transdermalnimi obliži Prometax trenutno ni podatkov.
Treatment As rivastigmine has a plasma half-life of about 3.4 hours and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose all Prometax transdermal patches should be removed immediately and no further transdermal patch should be applied for the next 24 hours.
Bolniku se v naslednjih 24 urah ne sme namestiti novih transdermalnih obližev.
An initial dose of 0.03 mg/ kg intravenous atropine sulphate is recommended, with subsequent doses based on clinical response.
Uporabe
Use of scopolamine as an antidote is not recommended.
62 skopolamina kot protistrupa ne priporočamo.
61 facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact cholinergic neurones.
Rivastigmin je zaviralec acetilholinesteraze in butirilholinesteraze karbamatne vrste, za katerega velja, da izboljšuje holinergični živčni prenos tako, da upočasnjuje razgradnjo acetilholina, ki ga sproščajo funkcionalno intaktni holinergični nevroni.
Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer’ s disease.
Zato bi lahko rivastigmin izboljšal stanje holinergično posredovanega upada kognitivnih funkcij pri demenci, povezani z Alzheimerjevo boleznijo.
Clinical studies in Alzheimer’ s dementia The efficacy of Prometax transdermal patches in patients with Alzheimer’ s dementia has been demonstrated in a 24-week double-blind core study and its open-label extension phase.
Klinične študije pri Alzheimerjevi demenci Učinkovitost transdermalnih obližev Prometax pri bolnikih z Alzheimerjevo demenco so dokazali v 24- tedenski dvojno slepi osnovni študiji in njenem odprtem podaljšku.
These include the ADAS-Cog (a performance-based measure of cognition) and the ADCS-CGIC (a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the ADCS-ADL (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).
Med njimi so ADAS- Cog (merilo za kognicijo, ki temelji na storilnosti), ADCS- CGIC (vsestranska globalna ocena bolnika, ki jo poda zdravnik ob upoštevanju negovalčeve ocene) in ADCS- ADL (negovalčeva ocena vsakodnevnih aktivnosti, med drugim osebne higiene, hranjenja, oblačenja, gospodinjskih opravil, na primer nakupovanja, ohranjanja zmožnosti orientacije v okolju kot tudi ukvarjanja z denarnimi zadevami).
The 24-week results for the three assessment tools are summarised in Table 2.
24- tedenski rezultati teh treh metod ocenjevanja so zbrani v preglednici 2.
transdermal patches
transdermalni
capsules
kapsule
9.5 mg/ 24 h
obliži
12 mg/ day
12 mg/ dan
ITT-LOCF population ADAS-Cog
9, 5 mg/ 24 h Skupina ITT- LOCF ADAS- Cog
Mean baseline ± SD Mean change at week 24 ± SD p-value versus placebo * p≤ 0.05 versus placebo
Povprečje ob izhodišču ± SD
50.1 ± 16.3 -0.1 ± 9.1 0.013*1
49, 2 ± 16, 0
49.3 ± 15.8 49.2 ± 16.0 -0.5 ± 9.5 -2.3 ± 9.4 0.039*1
63 Povprečna sprememba po 24 tednih ± SD
ITT:
Vrednost p proti placebu * p≤0, 05 proti placebu
Last Observation Carried Forward 1 Based on ANCOVA with treatment and country as factors and baseline value as a covariate.
ITT: namen zdraviti (Intent- To- Treat); LOCF: zadnje opazovanje preneseno naprej (Last Observation Carried Forward) 1 Na podlagi ANCOVA z zdravljenjem in državo kot faktorjema in izhodiščno vrednostjo kot sospremenljivko.
Negative ADAS-Cog changes indicate improvement.
Ocena < 4 na lestvici ADCS- CGIC pomeni izboljšanje.
ADCS-CGIC scores < 4 indicate improvement.
Klinično pomembno izboljšanje je bilo opredeljeno a priori kot izboljšanje na ADAS- Cog lestvici za vsaj 4 točke, brez poslabšanja v razvrstitvi ADCS- CGIC in brez poslabšanja na lestvici ADCS- ADL.
Patients with clinically significant response (%)
Bolniki s klinično pomembnim odzivom (%) Placebo Prometax Prometax kapsule transdermalni 12 mg/ dan obliži 9, 5 mg/ 24 h
Prometax Prometax
Skupina ITT- LOCF
= 251 17.4
= 251
N = 256 19.0
= 256
Absorption Absorption of rivastigmine from Prometax transdermal patches is slow.
Absorpcija Rivastigmin se iz transdermalnih obližev Prometax absorbira počasi.
The fluctuation index (FI), a measure of the relative difference between peak and trough concentrations((Cmax-Cmin)/ Cavg), was 0.58 for Prometax 4.6 mg/ 24 h transdermal patches and 0.77 for Prometax 9.5 mg/ 24 h transdermal patches, thus demonstrating a much smaller fluctuation between trough and peak concentrations than for the oral formulation (FI = 3.96 (6 mg/ day) and 4.15 (12 mg/ day)).
Fluktuacijska indeksa (FI), ki izražata relativno razliko med najvišjimi in najnižjimi koncentracijami ((Cmax- Cmin) / Cavg; pri tem je Cavg povprečna koncentracija v obdobju odmerjanja), sta bila 0, 58 pri transdermalnih obližih Prometax 4, 6 mg/ 24 h in 0, 77 pri transdermalnih obližih Prometax 9. 5 mg/ 24 h, kar kaže na veliko manjšo fluktuacijo od najnižjih do najvišjih koncentracij kot pri peroralnem odmerjanju (FI = 3, 96 za odmerjanje 6 mg/ dan in 4, 15 za odmerjanje
63 Exposure (AUC∞) to rivastigmine (and metabolite NAP266-90) was highest when the transdermal patch was applied to the upper back, chest, or upper arm and approximately 20– 30% lower when applied to the abdomen or thigh.
Izpostavljenost (AUC∞) rivastigminu (in presnovku NAP266- 90) je bila največja pri aplikaciji transdermalnega obliža na zgornji del hrbta, prsi ali nadlaket ter približno 20- 30% manjša pri aplikaciji na trebuh ali stegno.
Elderly subjects Age had no impact on the exposure to rivastigmine in Alzheimer’ s disease patients treated with Prometax transdermal patches.
65 Starejše osebe Pri bolnikih z Alzheimerjevo boleznijo, ki so jih zdravili s transdermalnimi obliži Prometax, starost ni vplivala na izpostavljenost rivastigminu.
Subjects with hepatic impairment No study was conducted with Prometax transdermal patches in subjects with hepatic impairment.
Osebe z okvaro jeter Pri osebah z okvaro jeter niso opravili nobene študije s transdermalnimi obliži Prometax.
Subjects with renal impairment No study was conducted with Prometax transdermal patches in subjects with renal impairment.
Osebe z okvaro ledvic Pri osebah z okvaro ledvic niso opravili nobene študije s transdermalnimi obliži Prometax.
64 Oral and topical dosing in animal studies was limited due to the sensitivity of the animal models used.
Peroralno in lokalno odmerjanje je bilo v raziskavah na živalih omejeno zaradi občutljivosti uporabljenih živalskih modelov.
Rivastigmine was not mutagenic in a standard battery of in vitro and in vivo tests, except in a chromosomal aberration test in human peripheral lymphocytes at a dose exceeding 104 times the foreseen clinical exposure.
V standardni bateriji testov in vitro in in vivo rivastigmin ni bil mutagen, razen v testu kromosomskih aberacij v človeških perifernih levkocitih v odmerku, ki je 104- krat presegal dotedanjo klinično izpostavljenost.
Prometax 9.5 mg/ 24 h transdermal patch
Prometax 9, 5 mg/ 24 h transdermalni obliž
The outside of the backing layer is beige and labelled with “ Prometax”, “ 9.5 mg/ 24 h” and “ BHDI”.
Zunanji del krovne plasti je rjavkasto bele (beige) barve z oznakami “ Prometax ”, “ 9. 5 mg/ 24 h ” in “ BHDI ”.
67 Switching from capsules or oral solution to transdermal patches Based on comparable exposure between oral and transdermal rivastigmine (see section 5.2), patients treated with Prometax capsules or oral solution can be switched to Prometax transdermal patches as follows: • A patient on a dose of 3 mg/ day oral rivastigmine can be switched to 4.6 mg/ 24 h transdermal patches. • A patient on a dose of 6 mg/ day oral rivastigmine can be switched to 4.6 mg/ 24 h transdermal patches. • A patient on a stable and well tolerated dose of 9 mg/ day oral rivastigmine can be switched to 9.5 mg/ 24 h transdermal patches.
69 Prehod z zdravljenja s kapsulami ali peroralno raztopino na zdravljenje z obliži Glede na to, da je izpostavljenost rivastigminu primerljiva pri peroralni in transdermalni aplikaciji (glejte poglavje 5. 2), lahko bolniki, ki se zdravijo s kapsulami ali peroralno raztopino Prometax, preidejo na zdravljenje s transdermalnimi obliži Prometax na naslednji način: • Bolnik, ki jemlje rivastigmin peroralno v odmerku 3 mg/ dan, lahko preide na zdravljenje s transdermalnimi obliži 4, 6 mg/ 24 h. • Bolnik, ki jemlje rivastigmin peroralno v odmerku 6 mg/ dan, lahko preide na zdravljenje s transdermalnimi obliži 4, 6 mg/ 24 h. • Bolnik, ki dobro prenaša rivastigmin peroralno v odmerku 9 mg/ dan in odmerka ne spreminja, lahko preide na zdravljenje s transdermalnimi obliži 9, 5 mg/ 24 h.
68 Patients with Alzheimer’ s disease may lose weight whilst taking cholinesterase inhibitors, including rivastigmine.
Bolniki z Alzheimerjevo boleznijo lahko hujšajo v času jemanja zaviralcev holinesteraze, tudi rivastigmina.
In peri/ postnatal studies in rats, an increased gestation time was observed.
71 opazili podaljšano obdobje brejosti.
General disorders and administration site conditions
72 Splošne težave in spremembe na mestu aplikacije
70 When doses higher than 9.5 mg/ 24 h were used in the above-mentioned study, dizziness, insomnia, agitation, decreased appetite, atrial fibrillation and cardiac failure were observed more frequently than with 9.5 mg/ 24 h or placebo, suggesting a dose effect relationship.
Kadar so v zgoraj navedeni študiji uporabljali odmerke, ki so bili višji od 9, 5 mg/ 24 h, so opažali vrtoglavost, nespečnost, agitiranost, izgubo teka, atrijsko fibrilacijo in popuščanje srca pogosteje kot pri odmerku 9, 5 mg/ 24 h ali pri placebu, kar nakazuje odvisnost od velikosti odmerka.
Use of scopolamine as an antidote is not recommended.
73 skopolamina kot protistrupa ne priporočamo.
71 facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact cholinergic neurones.
Rivastigmin je zaviralec acetilholinesteraze in butirilholinesteraze karbamatne vrste, za katerega velja, da izboljšuje holinergični živčni prenos tako, da upočasnjuje razgradnjo acetilholina, ki ga sproščajo funkcionalno intaktni holinergični nevroni.
49.3 ± 15.8 49.2 ± 16.0 -0.5 ± 9.5 -2.3 ± 9.4 0.039*1
74 Povprečna sprememba po 24 tednih ± SD
73 Exposure (AUC∞) to rivastigmine (and metabolite NAP266-90) was highest when the transdermal patch was applied to the upper back, chest, or upper arm and approximately 20– 30% lower when applied to the abdomen or thigh.
Izpostavljenost (AUC∞) rivastigminu (in presnovku NAP266- 90) je bila največja pri aplikaciji transdermalnega obliža na zgornji del hrbta, prsi ali nadlaket ter približno 20- 30% manjša pri aplikaciji na trebuh ali stegno.
Elderly subjects Age had no impact on the exposure to rivastigmine in Alzheimer’ s disease patients treated with Prometax transdermal patches.
76 Starejše osebe Pri bolnikih z Alzheimerjevo boleznijo, ki so jih zdravili s transdermalnimi obliži Prometax, starost ni vplivala na izpostavljenost rivastigminu.
74 Oral and topical dosing in animal studies was limited due to the sensitivity of the animal models used.
Peroralno in lokalno odmerjanje je bilo v raziskavah na živalih omejeno zaradi občutljivosti uporabljenih živalskih modelov.
76 ANNEX II
79 DODATEK II
The Marketing Authorization Holder ensures that the system of pharmacovigilance, as described in version 2 dated 22 July 2008 presented in Module 1.8.1. of the Marketing Authorization, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora vzpostaviti in zagotoviti delovanje sistema farmakovigilance, kot je navedeno v 1. verziji dovoljenja za promet z zdravilom v modulu 1. 8. 1, preden je zdravilo dostopno na tržišču in dokler je trženo zdravilo v uporabi.
78 ANNEX III
81 DODATEK III
Prometax 1.5 mg hard capsules Rivastigmine
Prometax 1, 5 mg trde kapsule rivastigmin
83 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
86 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Prometax 1.5 mg [folding box only]
Prometax 1, 5 mg [samo na škatli]
85 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
88 PODATKI NA ZUNANJI OVOJNINI
Prometax 3.0 mg hard capsules Rivastigmine
Prometax 3, 0 mg trde kapsule rivastigmin
87 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
90 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
88 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
91 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Prometax 3.0 mg [folding box only]
Prometax 3, 0 mg [samo na škatli]
90 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
93 PODATKI NA ZUNANJI OVOJNINI
Prometax 4.5 mg hard capsules Rivastigmine
Prometax 4, 5 mg trde kapsule rivastigmin
92 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
95 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
93 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
96 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
11.
97 11.
Prometax 4.5 mg [folding box only]
Prometax 4, 5 mg [samo na škatli]
95 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
98 PODATKI NA ZUNANJI OVOJNINI
Prometax 6.0 mg hard capsules Rivastigmine
Prometax 6, 0 mg trde kapsule rivastigmin
97 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
100 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
98 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
101 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Prometax 6.0 mg [folding box only]
Prometax 6, 0 mg [samo na škatli]
100 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
103 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Prometax 2 mg/ ml oral solution Rivastigmine
Prometax 2 mg/ ml peroralna raztopina rivastigmin
Prometax 2 mg/ ml [folding box only]
Prometax 2 mg/ ml [samo na škatli]
102 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
105 PODATKI NA ZUNANJI OVOJNINI
Prometax 4.6 mg/ 24 h transdermal patch rivastigmine
Prometax 4, 6 mg/ 24 h transdermalni obliž rivastigmin
104 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
107 PODATKI NA ZUNANJI OVOJNINI
106 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
109 PODATKI NA ZUNANJI OVOJNINI
108 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
111 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
109 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
112 PODATKI NA ZUNANJI OVOJNINI
Prometax 9.5 mg/ 24 h transdermal patch rivastigmine
Prometax 9, 5 mg/ 24 h transdermalni obliž rivastigmin
111 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
114 PODATKI NA ZUNANJI OVOJNINI
113 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
116 PODATKI NA ZUNANJI OVOJNINI
115 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
118 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
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 trde kapsule Prometax 3, 0 mg trde kapsule Prometax 4, 5 mg trde kapsule Prometax 6, 0 mg trde kapsule rivastigmin
What Prometax is and what it is used for 2.
Kaj je zdravilo Prometax in za kaj ga uporabljamo 2.
Before you take Prometax 3.
Kaj morate vedeti, preden boste vzeli zdravilo Prometax 3.
How to take Prometax 4.
Kako jemati zdravilo Prometax 4.
How to store Prometax 6.
Shranjevanje zdravila Prometax 6.
WHAT PROMETAX IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO PROMETAX IN ZA KAJ GA UPORABLJAMO
Prometax belongs to a class of substances called cholinesterase inhibitors.
Prometax pripada skupini snovi, ki se imenujejo zaviralci holinesteraze.
Prometax is used for the treatment of memory disorders in patients with Alzheimer’ s disease.
Prometax uporabljamo za zdravljenje motenj spomina pri bolnikih z Alzheimerjevo boleznijo.
Prometax is used for the treatment of dementia in patients with Parkinson’ s disease.
Prometax uporabljamo za zdravljenje demence pri bolnikih s Parkinsonovo boleznijo.
BEFORE YOU TAKE PROMETAX
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO PROMETAX
Before taking Prometax it is important that you read the following section and discuss any questions you might have with your doctor.
Preden vzamete Prometax, je pomembno, da preberete naslednje poglavje in se o vseh morebitnih vprašanjih pogovorite s svojim zdravnikom.
Do not take Prometax
Ne jemljite zdravila Prometax
- if you are allergic (hypersensitive) to rivastigmine or any of the other ingredients of Prometax.
- če ste alergični na (preobčutljivi za) rivastigmin ali katerokoli sestavino zdravila Prometax.
Take special care with Prometax
Bodite posebno pozorni pri uporabi zdravila Prometax
stomach ulcer, asthma or severe respiratory disease, difficulties in passing urine, or seizures (fits or convulsions).
nepravilen srčni utrip, aktivno želodčno razjedo, astmo ali hudo bolezen dihal, težave pri odvajanju vode ali epileptične napade (napade krčev), če zdravila Prometax več dni niste jemali, ne vzemite naslednjega odmerka, dokler se ne
- if you have not taken Prometax for several days, do not take the next dose until you have talked
-
to your doctor.
pogovorite s svojim zdravnikom,
118 The use of Prometax in children and adolescents (age below 18 years) is not recommended.
Pri otrocih in mladostnikih (starih manj kot 18 let) uporaba zdravila Prometax ni priporočena.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
121 Jemanje drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
If you have to undergo surgery whilst taking Prometax, you should inform the doctor before you are given any anaesthetics, because Prometax may exaggerate the effects of some muscle relaxants during anaesthesia.
Če morate v času jemanja zdravila Prometax na operacijo, morate obvestiti zdravnika, da jemljete Prometax, preden dobite kakršnokoli anestezijo, ker lahko Prometax med anestezijo poveča učinke nekaterih mišičnih relaksantov.