natgillin/translations-raw huggingface dataset:
• Do not expose the patch to any external heat sources (e.g. excessive sunlight, saunas, solarium)
- Obliža ne izpostavljajte zunanjim virom toplote (na primer prekomernemu sončenju, savni,
ADAS-Cog: improvement of at least 4 points CIBIC-Plus: improvement PDS: improvement of at least 10%
CIBIC-Plus: izboljšanje PDS: izboljšanje za najmanj
Following a single 3 mg or 6 mg oral dose, the mean oral clearance of rivastigmine was approximately 46-63% lower in patients with mild to moderate hepatic impairment (n=10, Child-Pugh score 5-12, biopsy proven) than in healthy subjects (n=10).
Po odmerjanju enkratnih peroralnih odmerkov 3 mg ali 6 mg je bil povprečni peroralni očistek rivastigmina pri bolnikih z blago do zmerno okvaro jeter (n=10, z oceno 5-12 na Child-Pughovi lestvici in s potrditvijo z biopsijo) približno za 46-63 % manjši kot pri zdravih osebah (n=10).
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, 0.77 for Prometax 9.5 mg/24 h transdermal patches and 0.72 for Prometax 13.3 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)).
Fluktuacijski indeks(FI), ki izraža relativno razliko med najvišjimi in najnižjimi koncentracijami ((Cmax-Cmin)/Cavg; pri tem je Cavg povprečna koncentracija v obdobju odmerjanja), je bil 0,58 pri transdermalnih obližih Prometax 4,6 mg/24 h, 0,77 pri transdermalnih obližih Prometax 9,5 mg/24 h in 0,72 pri transdermalnih obližih Prometax 13,3 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 12 mg/dan).
Infections and infestations Very rare
Infekcijske in parazitske bolezni zelo redki okužba sečil
The inter-patient variability in a steady-state study in Alzheimer's dementia was at most 45% (Cmax) and 43% (AUC0-24h) after use of the transdermal patch, and 71% and 73%, respectively, after administration of the oral form.
Interindividualna variabilnost v študiji dinamičnega ravnovesja pri bolnikih z Alzheimerjevo demenco je bila največ 45 % za Cmax in 43 % za AUC0-24h po uporabi transdermalnega obliža v primerjavi z 71 % za Cmax in 73 % za AUC0-24h po aplikaciji peroralne oblike.
Used transdermal patches should be folded in half, with the adhesive side inwards, placed in the original sachet and discarded safely and out of the reach and sight of children.
Po uporabi transdermalni obliž prepognite na pol z lepljivo stranjo navznoter, vložite v originalno vrečko in varno zavrzite nedosegljivo otrokom.
If treatment is interrupted for more than three days, it should be re-initiated with 4.6 mg/24 h.
Če zdravljenje prekinemo za več kot tri dni, ga moramo spet začeti z odmerkom 4,6 mg/24 h.
Taking the two medicines together could cause problems such as such as stiff limbs and trembling hands.
Sočasno jemanje obeh navedenih zdravil lahko povzroči težave, kot sta okorelost okončin in tresenje rok.
C-rivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours.
C, je bilo ledvično izločanje hitro, saj se je dejansko ves (>90 %) izločil v 24 urah.
By blocking these enzymes, Prometax 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.
Zdravilo Prometax z zaviranjem navedenih encimov omogoča zvišanje koncentracije acetilholina v možganih in s tem pomaga pri zmanjševanju simptomov Alzheimerjeve bolezni in demence v povezavi s Parkinsonovo boleznijo.
Prometax contains sodium benzoate
Zdravilo Prometax vsebuje natrijev benzoat
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.
Učinkovitost transdermalnih obližev Prometax pri bolnikih z Alzheimerjevo demenco so dokazali v 24-tedenski dvojno slepi, s placebom kontrolirani osnovni študiji in njenem odprtem podaljšku ter v 48-tedenski dvojno slepi primerjalni študiji.
If you accidentally take more Prometax than you should, inform your doctor.
Če ste vzeli večji odmerek zdravila Prometax, kot bi smeli Če nehote vzamete več zdravila Prometax, kot bi smeli, obvestite svojega zdravnika.
Patients with clinically significant hepatic impairment may experience more dose-dependent adverse reactions.
Pri bolnikih s klinično pomembno okvaro jeter lahko število od odmerka odvisnih neželenih učinkov večje.
If it helps you, you may write, for example, the day of the week, on the patch with a thin ball point pen.
Na obliž lahko s tankim kemičnim svinčnikom napišete na primer dan v tednu, če vam je to v pomoč.
• to patients with active gastric or duodenal ulcers or patients predisposed to these conditions because rivastigmine may cause increased gastric secretions (see section 4.8);
• bolnikom z aktivnimi razjedami želodca ali dvanajstnika ali bolnikom z nagnjenostjo k tem boleznim, ker rivastigmin lahko povzroči povečano izločanje želodčne kisline (glejte poglavje 4.8);
Cut the sachet along the dotted line with scissors and remove the patch from the sachet.
Vrečko s škarjami prerežite po črtkani črti in izvlecite obliž iz vrečke.
Prometax oral solution should be used within 1 month of opening the bottle.
Peroralno raztopino Prometax je treba porabiti v enem mesecu po prvem odprtju steklenice.
n Mean n Mean DLS M
n povpre čje n povpre čje
Prometax 2 mg/ml [folding box only]
Prometax 2 mg/ml [samo na škatli]
When observed in patients treated with Prometax transdermal patches, skin irritation was mostly slight or mild in severity.
Pri bolnikih, ki so se zdravili s transdermalnimi obliži Prometax, so večinoma opažali le rahlo ali blago izraženo vnetje.
• Patient reminder card
• opozorilno kartico za bolnika,
• Paediatric population: There is no relevant use of Prometax in the paediatric population in the treatment of Alzheimer's disease.
• Pediatrična populacija: Zdravilo Prometax ni namenjeno za uporabo pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
Particular caution should be exercised in titrating these patients (see sections 4.4 and 5.2).
Pri titriranju odmerka tem bolnikom je potrebna posebna previdnost (glejte poglavji 4.4 in 5.2).
If you forget to use Prometax
Če ste pozabili uporabiti zdravilo Prometax
The incidence of application site skin reactions leading to discontinuation was ≤2.3% in patients treated with Prometax transdermal patches.
Do reakcij na mestu aplikacije, zaradi katerih je bilo treba zdravljenje prekiniti, je prišlo pri ≤2,3 % bolnikov, ki so se zdravili s transdermalnimi obliži Prometax.
A relationship between active substance exposure at steady state (rivastigmine and metabolite NAP226-90) and bodyweight was observed in Alzheimer's dementia patients.
Pri bolnikih z Alzheimerjevo demenco so opazovali razmerje med telesno maso in izpostavljenostjo zdravilni učinkovini (rivastigminu in presnovku NAP226-90) v stanju dinamičnega ravnovesja.
Crivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours.
C, je bilo ledvično izločanje hitro, saj se je dejansko ves (> 90 %) izločil v 24 urah.
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 10
V standardni bateriji testov in vitro in in vivo rivastigmin ni bil mutagen, razen v testu kromosomskih aberacij v človeških perifernih levkocitih v odmerku, za 10
• The patch should be pressed down firmly for at least 30 seconds using the palm of the hand until the edges stick well.
• Obliž je treba z dlanjo čvrsto pritiskati na kožo najmanj 30 sekund, dokler se robovi dobro ne prilepijo.
28 hard capsules
28 trdih kapsul
Particular caution must be exercised in titrating these patients (see sections 4.2 and 5.2).
Pri titriranju odmerka tem bolnikom je potrebna posebna previdnost (glejte poglavji 4.2 in 5.2)
Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
V preglednici 1 so neželeni učinki navedeni glede na organski sistem po MedDRA klasifikaciji in glede na kategorijo pogostnosti.
EXP Use Prometax oral solution within 1 month of opening the bottle.
EXP Peroralno raztopino Prometax porabite v 1 mesecu po prvem odprtju steklenice.
• Patients with body weight below 50 kg may experience more adverse reactions and may be more likely to discontinue due to adverse reactions (see section 4.2).
• Pri bolnikih s telesno maso manjšo od 50 kg je lahko število neželenih učinkov večje, obstaja pa tudi večja verjetnost, da bodo zaradi neželenih učinkov zdravljenje prekinili (glejte poglavje 4.2).
The following adverse reactions have only been observed with Prometax capsules and oral solution and not in clinical studies with Prometax transdermal patches: malaise, confusion, sweating increased (common); duodenal ulcers, angina pectoris (rare); gastrointestinal haemorrhage (very rare); and some cases of severe vomiting were associated with oesophageal rupture (not known).
Naslednje neželene učinke so opažali samo pri uporabi kapsul in peroralne raztopine Prometax, ne pa v kliničnih študijah s transdermalnimi obliži Prometax: splošno slabo počutje, zmedenost, povečano potenje (pogosto); razjede dvanajstnika, angino pektoris (redko); krvavitev v prebavila (zelo redko); in nekaj primerov hudega bruhanja, ki je bilo povezano z rupturo požiralnika (pogostnost neznana).
• Do not use this medicine after the expiry date which is stated on the carton after EXP.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Contact with the eyes should be avoided after handling Prometax transdermal patches (see section 5.3).
Po rokovanju s transdermalnimi obliži Prometax se ne sme dotikati oči (glejte poglavje 5.3).
Then press the patch firmly in place for at least 30 seconds using the palm of the hand to make sure that the edges stick well.
Nato obliž z dlanjo čvrsto pritiskajte na kožo najmanj 30 sekund, da se robovi obliža dobro prilepijo.
If you forget to take Prometax
Če ste pozabili vzeti zdravilo Prometax
You should not breast-feed during treatment with Prometax.
Med zdravljenjem z zdravilom Prometax ne smete dojiti.
• The highest dose that should be taken is 6.0 mg twice a day.
• Najvišji dovoljeni odmerek je 6,0 mg dvakrat na dan.
Carefully remove the existing patch before putting on a new one.
Previdno odstranite obliž, ki je že na koži, in šele potem namestite novega.
• Use Prometax oral solution within 1 month of opening the bottle.
• Peroralno raztopino Prometax porabite v 1 mesecu po prvem odprtju steklenice.
Rare (may affect up to 1 in 1,000 people) • Falling
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) • padci
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
ITT: namen zdraviti (Intent-To-Treat); RDO: upoštevani izpadli primeri (Retrieved Drop Outs); LOCF: zadnje opazovanje preneseno naprej (Last Observation Carried Forward)
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.
Ker ima rivastigmin plazemski razpolovni čas okrog 3,4 ure in trajanje zaviranja acetilholinesteraze okrog 9 ur, v primeru asimptomatičnega prevelikega odmerka priporočamo takojšnjo odstranitev vseh transdermalnih obližev Prometax.
112 hard capsules
112 trdih kapsul
Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer's disease and Parkinson's disease.
Zato bi lahko rivastigmin izboljšal stanje holinergično posredovanega upada kognitivnih funkcij pri demenci, povezani z Alzheimerjevo boleznijo in s Parkinsonovo boleznijo.
Similarly a larger effect was observed in Parkinson's disease patients with visual hallucinations (see section 5.1).
Prav tako so boljši učinek opazili pri tistih bolnikih s Parkinsonovo boleznijo, ki so imeli vidne halucinacije (glejte poglavje
The outer layer is beige and labelled with the following: - “Prometax”, “4.6 mg/24 h” and “AMCX”, - “Prometax”, “9.5 mg/24 h” and “BHDI”, - “Prometax”, “13.3 mg/24 h” and “CNFU”.
Zunanja plast je rjavkasto bele barve z eno od naslednjih oznak: - “Prometax”, “4.6 mg/24 h” in “AMCX”, - “Prometax”, “9.5 mg/24 h” in “BHDI”, - “Prometax”, “13.3 mg/24 h” in “CNFU”.
56 hard capsules
56 trdih kapsul
FOLDING BOX AND BOTTLE LABEL
NALEPKA NA ŠKATLI IN STEKLENICI
What you need to know before you use Prometax
Kaj morate vedeti, preden boste uporabili zdravilo Prometax
95% CI p-value
DLSM 95% IZ
7 transdermal patches 30 transdermal patches
7 transdermalnih obližev 30 transdermalnih obližev
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.
V primeru, da ste noseči, je treba pretehtati koristi uporabe zdravila Prometax in možne učinke na nerojenega otroka.
Alpha-tocopherol Silicone oil Dimethicone
Adhezivni matriks zdravila α-tokoferol silikonsko olje dimetikon
Attaching the syringe to the bottle
Nameščanje brizge na steklenico
Each patch is sealed in a sachet that protects it until you are ready to put it on. Do not open the sachet or remove a patch until just before you apply it.
Vsak obliž je zaprt v vrečki, ki ga ščiti, dokler ga ne želite namestiti.
• Fainting or accidentally falling
• omedlevica ali nezgodni padci
What you need to know before you take Prometax
Kaj morate vedeti, preden boste vzeli zdravilo Prometax
No dose adjustment is necessary in patients with renal impairment (see section 4.2).
Pri bolnikih z okvaro ledvic prilagajanje odmerkov ni potrebno (glejte poglavje 4.2).
• Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vrečki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
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 10
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.
Your doctor will also monitor your weight whilst you are taking this medicine.
V času jemanja tega zdravila bo zdravnik spremljal tudi vašo telesno maso.
Patients with severe hepatic impairment have not been studied, however, Prometax capsules may be used in this patient population provided close monitoring is exercised (see sections 4.4 and 5.2).
Uporabe zdravila pri bolnikih s težko jetrno okvaro niso proučili, bolniki iz te populacije lahko kljub temu uporabljajo zdravilo Prometax v obliki kapsul, vendar jih je treba skrbno spremljati (glejte poglavji 4.4 in 5.2).
ITT + RDO population (n=87)
Skupina ITT + RDO (n=87)
After switching to 4.6 mg/24 h transdermal patches, provided these are well tolerated after a minimum of four weeks of treatment, the dose of 4.6 mg/24 h should be increased to 9.5 mg/24 h, which is the recommended effective dose.
Če bolnik po prehodu na zdravljenje s transdermalnimi obliži 4,6 mg/24 h ta odmerek dobro prenaša, je treba po najmanj štirih tednih zvišati odmerek s 4,6 mg/24 h na 9,5 mg/24 h, kar je priporočeni učinkoviti odmerek.
One of the inactive ingredients in Prometax oral solution is sodium benzoate.
Ena od neaktivnih sestavin peroralne raztopine Prometax je natrijev benzoat.
These include the ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, a performance based measure of cognition), the CIBIC-Plus (Clinician's Interview Based Impression of Change-Plus, a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the PDS (Progressive Deterioration Scale, 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 relating to finances, etc.).
Med njimi so ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, Lestvica za oceno kognitivnih sposobnosti bolnikov z Alzheimerjevo boleznijo, merilo kognitivne zmogljivosti, ki temelji na izvrševanju aktivnosti), CIBIC-Plus (Clinician's Interview Based Impression of ChangePlus, Zdravnikova ocena spremembe bolezni na podlagi pogovora, celostno globalno ocenjevanje bolnika, ki ga opravlja zdravnik in ki zajema tudi podatke, ki jih daje/-jo negovalec/-ci) in PDS (Progressive Deterioration Scale, Lestvica progresivnega slabšanja, negovalčeva ocena vsakodnevnih aktivnosti, na primer osebne higiene, hranjenja, oblačenja, gospodinjskih opravil, na primer nakupovanja, ohranjanje zmožnosti orientacije v okolju, pa tudi ukvarjanje z denarnimi zadevami itn.).
• Keep the transdermal patch in the sachet until use.
• Pred uporabo shranjujte transdermalni obliž v vrečki.
• Renal impairment: No dose adjustment is necessary for patients with renal impairment (see section 5.2).
• Okvara ledvic: Pri bolnikih z okvaro ledvic ni potrebno prilagajati odmerjanja (glejte poglavje
Cardiac arrhythmia (e.g. bradycardia, atrio-ventricular block, atrial fibrillation and tachycardia)
Srčne bolezni redki angina pektoris zelo redki srčne aritmije (npr. bradikardija, atrioventrikularni blok, atrijska fibrilacija in tahikardija)
The following additional adverse reactions have been observed with Prometax transdermal patches: delirium, pyrexia, decreased appetite, urinary incontinence (common), psychomotor hyperactivity (uncommon), erythema, urticaria, vesicles, allergic dermatitis (not known).
Pri uporabi transdermalnih obližev Prometax so dodatno opažali še naslednje neželene učinke: delirij, zvišano telesno temperaturo, zmanjšan apetit, urinska inkontinenca (pogosto), psihomotorična hiperaktivnost (občasno), eritem, urtikarija, mehurčki, alergijski dermatitis (pogostnost neznana).
ADCS-CGIC scores <4 indicate improvement.
Ocena <4 na lestvici ADCS-CGIC pomeni izboljšanje.
Administration of rivastigmine oral solution with food delays absorption (tmax) by 74 min and lowers Cmax by 43% and increases AUC by approximately
Jemanje peroralne raztopine rivastigmina skupaj s hrano upočasni absorpcijo (tmax) za 74 minut, zmanjša Cmax za 43 % ter poveča AUC za okrog 9 %.
Also contains: polyethylene terephthalate film lacquered, alpha-tocopherol, poly(butylmethacrylate, methylmethacrylate), acrylic copolymer, silicone oil, dimethicone, polyester film fluoropolymercoated.
Vsebuje tudi: lakiran polietilentereftalatni film, α-tokoferol, polimer (butilmetakrilat, metilmetakrilat), akrilni kopolimer, silikonsko olje, dimetikon, poliestrski film obložen s fluoro-polimerom.
Overdose with Prometax transdermal patch resulting from misuse/dosing errors (application of multiple patches at a time) has been reported in the post-marketing setting and rarely in clinical trials.
V obdobju trženja zdravila so poročali o prevelikem odmerjanju s transdermalnimi obliži Prometax, do česar je prišlo zaradi nepravilne uporabe/odmerjanja (nameščenih več obližev hkrati) , v kliničnih študijah pa so o takih primerih poročali le redko.
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.
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.
• Fits (seizures)
• napadi krčev (epileptični napadi)
PC: [folding box only] SN: [folding box only] NN: [folding box only]
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PC: [samo na škatli]
Parkinson's disease (worsening) Salivary hypersecretion Dyskinesia
Parkinsonova bolezen (poslabšanje) Čezmerno izločanje sline
What Prometax is and what it is used for What you need to know before you use Prometax How to use Prometax
Kaj je zdravilo Prometax in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Prometax Kako uporabljati zdravilo Prometax Možni neželeni učinki
Filling the syringe
Polnjenje brizge
Patients with severe hepatic impairment have not been studied, however, Prometax oral solution may be used in this patient population provided close monitoring is exercised (see sections 4.4 and 5.2).
Uporabe zdravila pri bolnikih s težko jetrno okvaro niso proučili, bolniki iz te populacije lahko kljub temu uporabljajo zdravilo Prometax peroralno raztopino, vendar jih je treba skrbno spremljati (glejte poglavji 4.4 in 5.2).
• Push the nozzle of the syringe into the hole in the white stopper.
• Nastavek brizge vstavite v odprtino belega zamaška.
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.
Peroralna raztopina Prometax je na voljo v obliki 50 ml ali 120 ml bistre rumene raztopine (2,0 mg/ml baze), v jantarno obarvani steklenici z za otroke varno zaporko, oblogo iz penaste gume, s kapalnim vložkom in s prilegajočim se zamaškom.
There is no relevant use of Prometax in the paediatric population in the treatment of Alzheimer's disease.
Zdravila Prometax ni smiselno uporabljati pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
What Prometax is and what it is used for What you need to know before you take Prometax How to take Prometax
Kaj je zdravilo Prometax in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Prometax Kako jemati zdravilo Prometax Možni neželeni učinki
Prometax transdermal patches 9.5 mg/24 h N = 251
Prometax transdermalni obliži 9,5 mg/24 h N = 251
ADAS-Cog LOCF
ADAS-Cog metoda LOCF
In pregnant animals, rivastigmine and/or metabolites crossed the placenta.
Pri brejih živalih so rivastigmin in/ali njegovi presnovki prehajali skozi posteljico.
colloidal anhydrous silica, gelatin, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171) and shellac.
- Druge sestavine zdravila so hipromeloza, magnezijev stearat, mikrokristalna celuloza, koloidni silicijev dioksid, želatina, rumeni železov oksid (E172), rdeči železov oksid (E172), titanov dioksid (E171) in šelak.
• Feeling agitated
• občutek vznemirjenosti
ITT + RDO population (n=329)
Skupina ITT + RDO (n=329)
The active substance of Prometax is rivastigmine.
Zdravilna učinkovina v zdravilu Prometax je rivastigmin.
Nightmares
• nočne more
No pharmacokinetic interaction was observed between rivastigmine and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers.
Med peroralnim rivastigminom in digoksinom, varfarinom, diazepamom ali fluoksetinom v študijah na zdravih prostovoljcih niso opazili farmakokinetičnega medsebojnega delovanja.
How to use Prometax
Kako uporabljati zdravilo Prometax
Each ml contains 2 mg rivastigmine present as rivastigmine hydrogen tartrate.
Vsak ml vsebuje 2 mg rivastigmina v obliki rivastigminijevega hidrogentartrata.
You may have side effects more often when you start your medicine or when your dose is increased.
Neželeni učinki bodo morda pogostejši na začetku jemanja zdravila in ob zviševanju odmerka.
OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
ŠKATLICA ZA SKUPNO PAKIRANJE (VKLJUČNO Z "BLUE BOX" PODATKI)
Where to apply your Prometax transdermal patch
Kam namestiti transdermalni obliž Prometax