natgillin/translations-raw huggingface dataset:
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.).
ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, Lestvica za oceno kognitivnih sposobnosti bolnikov z Alzheimerjevo boleznijo, merilo za kognicijo, ki temelji na storilnosti), CIBIC-Plus (Clinician's Interview Based Impression of Change-Plus, 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
One of the excipients in Rivastigmine HEXAL oral solution is sodium benzoate.
Ena od pomožnih snovi peroralne raztopine zdravila Rivastigmin HEXAL je natrijev benzoat.
Table 1 Infections and infestations
Preglednica 1 Infekcijske in parazitske bolezni zelo redki okužba sečil
- This medicine has been prescribed for you only .
- Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
Rivastigmine should be administered twice a day, with morning and evening meals.
Rivastigmin mora bolnik jemati dvakrat na dan, z jutranjim in večernim obrokom.
Rare (may affect up to 1 in 1,000 people)
Redki (pojavijo se pri do 1 bolniku od 1.000)
• Ulcers in your stomach or intestine
• bolečine v trebuhu,
Re-initiation of therapy
Ponoven začetek zdravljenja
• Fainting or accidentally falling
• omedlevica ali občasni padci,
Package leaflet: Information for the patient Rivastigmine HEXAL 2 mg/ml oral solution
Navodilo za uporabo: Informacije za bolnika Rivastigmin HEXAL 2 mg/ml peroralna raztopina rivastigmin
If you are pregnant, the benefits of using Rivastigmine HEXAL must be assessed against the possible effects on your unborn child. Rivastigmine HEXAL should not be used during pregnancy unless clearly necessary.
V primeru, da ste noseči, je treba pretehtati koristi uporabe zdravila Rivastigmin HEXAL in možne učinke na nerojenega otroka.
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).
delirij, zvišano telesno temperaturo, zmanjšan apetit, urinska inkontinenca (pogosti), psihomotorična hiperaktivnost (občasni), eritem, urtukarija, vezikli, alergijski dermatitis (neznana).
The active substance of Rivastigmine HEXAL is rivastigmine.
Zdravilna učinkovina v zdravilu Rivastigmin HEXAL je rivastigmin.
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).
V študiji pri bolnikih, ki so imeli demenco v povezavi s Parkinsonovo boleznijo in so bili zdravljeni s transdermalnimi obliži z rivastigminom, so opazili naslednji neželeni učinek: agitiranost (pogosti).
No dose adjustment is necessary for patients with mild to moderate renal or hepatic impairment.
Pri bolnikih z blago do zmerno okvaro ledvic ali jeter ni potrebno prilagajati odmerjanja.
These patients have some side effects more often.
Pri teh bolnikih so nekateri neželeni učinki bolj pogosti, poleg tega pa se pri njih pojavljajo nekateri dodatni neželeni učinki:
• Feeling restless
• občutek nemira
Movement disorder Bradykinesia
Diskinezija Parkinsonizem Hipokinezija Gibalne motnje Bradikinezija Distonija
Parkinson's disease (worsening) Bradykinesia
Parkinsonova bolezen (poslabšanje)
Each Rivastigmine HEXAL 4.5 mg capsule contains 4.5 mg of rivastigmine.
Ena kapsula Rivastigmin HEXAL 4,5 mg vsebuje 4,5 mg rivastigmina.
See section 4
Glejte poglavje 4
Some people who have accidentally taken too much Rivastigmine HEXAL have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations.
Rivastigmin HEXAL je prišlo do navzee (slabosti s siljenjem na bruhanje), bruhanja, driske, visokega krvnega tlaka in halucinacij.
Each Rivastigmine HEXAL 6 mg capsule contains 6 mg of rivastigmine.
Ena kapsula Rivastigmin HEXAL 6 mg vsebuje 6 mg rivastigmina.
Each Rivastigmine HEXAL 1.5 mg capsule contains 1.5 mg of rivastigmine.
Ena kapsula Rivastigmin HEXAL 1,5 mg vsebuje 1,5 mg rivastigmina.
The major metabolite NAP226-90 also did not show a genotoxic potential.
Tudi poglavitni presnovek NAP226-90
Hyperhydrosis Allergic dermatitis (disseminated)
Bolezni kože in podkožja pogosti neznana hiperhidroza alergijski dermatitis (diseminiran)
Rivastigmine HEXAL 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.
To je napredujoča bolezen možganov, ki postopoma prizadene spomin in intelektualne sposobnosti ter vpliva na vedenje bolnika.
- The active substance is rivastigmine hydrogen tartrate.
- Zdravilna učinkovina je rivastigminijev hidrogentartrat.
CARTON FOR HDPE BOTTLE LABEL FOR HDPE BOTTLE
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA ZA PLASTENKO IZ HDPE NALEPKA ZA PLASTENKO IZ HDPE
Each Rivastigmine HEXAL 3 mg capsule contains 3 mg of rivastigmine.
Ena kapsula Rivastigmin HEXAL 3 mg vsebuje 3 mg rivastigmina.
Only for carton box: Rivastigmine HEXAL 2 mg/ml
Samo za kartonsko škatlo: Rivastigmin HEXAL 2 mg/ml
The mean actual daily dose for responders in the 6-12 mg group, corresponding to this definition, was 9.3 mg.
Povprečni dejanski dnevni odmerek za bolnike z odzivom na zdravljenje po navedeni opredelitvi je bil 9,3 mg v skupini s 6-12 mg. Pomembno je omeniti, da se lestvice, ki se uporabljajo pri tej indikaciji, razlikujejo in neposredne primerjave rezultatov za različna zdravilna sredstva niso možne.
Rivastigmine HEXAL 1.5 mg hard capsules:
Rivastigmin HEXAL 1,5 mg trde kapsule:
Adverse reactions in Table 1 and Table 2 are listed according to MedDRA system organ class and frequency category.
Preglednica neželenih učinkov V preglednici 1 in preglednici 2 so neželeni učinki navedeni glede na organski sistem po MedDRA
Only for carton box: Rivastigmine HEXAL 1.5 mg
Samo za kartonsko škatlo: Rivastigmin HEXAL 1,5 mg
Cholinesterase inhibitors, including rivastigmine, have been associated with weight loss in these patients.
Hujšanje pri teh bolnikih povezujejo z zaviralci holinesteraze, med drugim z rivastigminom.
- If you get any side effects , talk to your doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Rivastigmine oral solution should be administered twice a day, with morning and evening meals.
Peroralno raztopno rivastigmina mora bolnik jemati dvakrat na dan, z jutranjim in večernim obrokom.
Adjusted treatment difference p-value versus placebo
Vrednost p proti placebu
Uncommon (may affect up to 1 in 100 people) • Hyperactivity (high level of activity, restlessness)
Občasni (pojavijo se pri do 1 bolniku od 100) • depresija,
Gastrointestinal disorders
Elternovim testom
• Stomach pain
• bolečine v trebuhu
• Fits (seizures)
• napadi krčev (epileptični napadi),
• Fainting
• omedlevica
However, due to increased exposure in these populations dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant renal or hepatic impairment might experience more dose-dependent adverse reactions.
naj se odmerjanje titrira glede na individualno prenašanje, saj je pri bolnikih s klinično pomembno okvaro ledvic ali jeter lahko število neželenih učinkov bolj odvisno od odmerka.
If treatment is interrupted for more than three days, it should be re-initiated at 1.5 mg twice daily.
Ponoven začetek zdravljenja Če je zdravljenje prekinjeno za več kot tri dni, ga moramo spet začeti z odmerkom 1,5 mg dvakrat na dan. Nato moramo opraviti titriranje odmerka, kot je opisano zgoraj.
Rivastigmine HEXAL 2 mg/ml oral solution
Rivastigmin HEXAL 2 mg/ml peroralna raztopina
• Changes in how well your liver is working
• spremembe v delovanju jeter.
Only for carton box: Rivastigmine HEXAL 4.5 mg
Samo za kartonsko škatlo: Rivastigmin HEXAL 4,5 mg
Only for carton box: Rivastigmine HEXAL 6 mg
Samo za kartonsko škatlo: Rivastigmin HEXAL 6 mg
Rivastigmine HEXAL 4.5 mg hard capsules:
Rivastigmin HEXAL 4,5 mg trde kapsule:
Parkinsonism
Parkinsonove bolezni)
Dose titration: Adverse reactions (e.g. hypertension and hallucinations in patients with Alzheimer's dementia and worsening of extrapyramidal symptoms, in particular tremor, in patients with dementia associated with Parkinson's disease) have been observed shortly after dose increase.
hipertenzijo in halucinacije pri bolnikih z Alzheimerjevo demenco in poslabšanje ekstrapiramidnih simptomov pri bolnikih z demenco v povezavi s Parkinsonovo boleznijo).
difficulty in carrying out movements and muscle weakness
Motnje ravnotežja Otrdelost mišic in skeleta Rigor
Nightmares
• nočne more.
Only for carton box: 2D barcode carrying the unique identifier included.
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
Each capsule contains rivastigmine hydrogen tartrate corresponding to 4,5 mg rivastigmine.
Ena kapsula vsebuje rivastigminijev hidrogentartrat, ki ustreza 4,5 mg rivastigmina.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ALU/PVC BLISTER
PRETISNI OMOT IZ ALU/PVC
Only for carton box: Rivastigmine HEXAL 3 mg
Samo za kartonsko škatlo: Rivastigmin HEXAL 3 mg
Rivastigmine HEXAL 1.5 mg hard capsules rivastigmine (as hydrogen tartrate)
Rivastigmin HEXAL 1,5 mg trde kapsule rivastigmin (v obliki hidrogentartrata)
Each capsule contains 6 mg of rivastigmine (as hydrogen tartrate).
Ena kapsula vsebuje 6 mg rivastigmina (v obliki hidrogentartrata).
- if you have, or have ever had, asthma or severe respiratory disease.
- če imate ali ste imeli epileptične napade, - če imate ali ste imeli astmo ali hudo bolezen dihal - če imate ali ste imeli poslabšano delovanje ledvic; - če imate ali ste imeli poslabšano delovanje jeter;
Each capsule contains rivastigmine hydrogen tartrate corresponding to 1,5mg rivastigmine.
Ena kapsula vsebuje rivastigminijev hidrogentartrat, ki ustreza 1,5 mg rivastigmina.
Each capsule contains rivastigmine hydrogen tartrate corresponding to 6 mg rivastigmine.
Ena kapsula vsebuje rivastigminijev hidrogentartrat, ki ustreza 6 mg rivastigmina.
Rivastigmine HEXAL 2 mg/ml oral solution rivastigmine (as hydrogen tartrate)
Rivastigmin HEXAL 2 mg/ml peroralna raztopina rivastigmin (v obliki hidrogentartrata)
Parkinson's disease (worsening) Salivary hypersecretion Dyskinesia
Parkinsonova bolezen (poslabšanje) bradikinezija diskinezija hipokinezija rigidnost s fenomenom zobatega kolesa distonija
Gait abnormality
Nenormalnosti hoje
Each capsule contains 4.5 mg of rivastigmine (as hydrogen tartrate).
Ena kapsula vsebuje 4,5 mg rivastigmina (v obliki hidrogentartrata).
- if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea.
- če imate majhno telesno maso, - če imate prebavne težave, kot so slabost s siljenjem na bruhanje (navzea), bruhanje in driska.
Type III amber glass bottle with a child-resistant cap, dip tube and self aligning plug.
Steklenica iz temno obarvanega stekla tipa III, z za otroke varno zaporko, in kapalnim vložkom, vstavljenim v vrat steklenice.
There is no relevant use of Rivastigmine HEXAL in the paediatric population in the treatment of Alzheimer's disease.
V pediatrični populaciji ni ustrezne uporabe zdravila Rivastigmin HEXAL za zdravljenje
Each ml contains rivastigmine hydrogen tartrate corresponding to 2g rivastigmine.
En ml vsebuje rivastigminijev hidrogentartrat, ki ustreza 2 mg rivastigmina.
Uncommon (may affect up to 1 in 100 people)
Občasni (pojavijo se pri do 1 bolniku od 100)
• Put the child resistant cap back on the bottle to close it.
• Steklenico zaprite z za otroke varno zaporko.
Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “RIV 4.5 mg” on the body.
Belkast do rahlo rumen prašek v kapsuli z rdečim pokrovčkom in rdečim telesom kapsule z belim napisom “RIV 4,5 mg”.
- Printing ink: - Shellac - Red iron oxide (E172)
- rdeči železov oksid (E172)
• Chest pain
• bolečina v prsih
Each capsule contains 3 mg of rivastigmine (as hydrogen tartrate).
Ena kapsula vsebuje 3 mg rivastigmina (v obliki hidrogentartrata).
Rivastigmine HEXAL 4.5 mg hard capsules rivastigmine (as hydrogen tartrate)
Rivastigmin HEXAL 4,5 mg trde kapsule rivastigmin (v obliki hidrogentartrata)
Each ml contains 2.0 mg of rivastigmine (as hydrogen tartrate).
1 ml vsebuje 2 mg rivastigmina (v obliki hidrogentartrata).
Each capsule contains rivastigmine hydrogen tartrate corresponding to 3 mg rivastigmine.
Ena kapsula vsebuje rivastigminijev hidrogentartrat, ki ustreza 3 mg rivastigmina.
Each capsule contains 1.5 mg of rivastigmine (as hydrogen tartrate).
Ena kapsula vsebuje 1,5 mg rivastigmina (v obliki hidrogentartrata).
- Rivastigmine HEXAL 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint “RIV 4.5 mg” on the body.
- Rivastigmin HEXAL 4,5 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rdeč pokrovček in rdeče telo kapsule z belim napisom “RIV 4,5 mg”.
- Rivastigmine HEXAL 3 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “RIV 3 mg” on the body.
- Rivastigmin HEXAL 3 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo oranžen pokrovček in oranžno telo kapsule z rdečim napisom “RIV 3 mg”.
Urinary infection
• okužbe sečil
- Rivastigmine HEXAL 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with a red imprint “RIV 1.5 mg” on the body.
- Rivastigmin HEXAL 1,5 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rumen pokrovček in rumeno telo kapsule z rdečim napisom “RIV 1,5 mg”.
Rivastigmine HEXAL 6 mg hard capsules rivastigmine (as hydrogen tartrate)
Rivastigmin HEXAL 6 mg trde kapsule rivastigmin (v obliki hidrogentartrata)
Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint “RIV 3 mg” on the body.
Belkast do rahlo rumen prašek v kapsuli z oranžnim pokrovčkom in oranžnim telesom kapsule z rdečim napisom “RIV 3 mg”.
HOW TO STORE RIVASTIGMINE HEXAL
Shranjevanje zdravila Rivastigmin HEXAL
- Rivastigmine HEXAL 6 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “RIV 6 mg” on the body.
- Rivastigmin HEXAL 6 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rdeč pokrovček in oranžno telo kapsule z rdečim napisom “RIV 6 mg”.
Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “RIV 6 mg” on the body.
Belkast do rahlo rumen prašek v kapsuli z rdečim pokrovčkom in oranžnim telesom kapsule z rdečim napisom “RIV 6 mg”.
Hypertension Hypotension
Žilne bolezni pogosti občasni hipertenzija hipotenzija
Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “RIV 1.5 mg” on the body.
Belkast do rahlo rumen prašek v kapsuli z rumenim pokrovčkom in rumenim telesom kapsule z rdečim napisom “RIV 1,5 mg”.
Rivastigmine HEXAL 3 mg hard capsules rivastigmine (as hydrogen tartrate)
Rivastigmin HEXAL 3 mg trde kapsule rivastigmin (v obliki hidrogentartrata)
Restlessness Hallucination, visual Depression Aggression
Psihiatrične motnje pogosti pogosti pogosti pogosti pogosti pogostnost neznana nespečnost tesnoba nemir halucinacije, vizualne depresija agresivnost
• Unusually slow movements or movements you cannot control
• neobičajno počasni gibi ali nehoteni gibi
(n=289) n/a
(n=289)
Common (may affect up to 1 in 10 people)
Pogosti (pojavijo se pri do 1 bolniku od 10)
Bradycardia Arial fibrillation Atrioventricular block Sick sinus syndrome
Srčne bolezni pogosti občasni občasni pogostnost neznana bradikardija atrijska fibrilacija atrioventrikularni blok bolezen sinusnega vozla
Mean baseline ± SD Mean change at 24 weeks ± SD
24 tednih ± SD
Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists.
Priporočeni največji dnevni odmerek je 6 mg dvakrat na dan. Vzdrževalno zdravljenje lahko nadaljujemo, dokler ima bolnik od njega terapevtske koristi.
Cardiac arrhythmia (e.g. bradycardia, atrioventricular block, atrial fibrillation and tachycardia)
Srčne bolezni redki zelo redki pogostnost neznana angina pektoris srčne aritmije (npr. bradikardija, atrioventrikularni blok,
• Urinary tract infection
• okužba sečil,
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
ODGOVOREN ZA SPROŠČANJE SERIJE
Worsening (including bradykinesia, dyskinesia, gait abnormality) and an increased incidence or severity of tremor have been observed in patients with dementia associated with Parkinson's disease (see section 4.8).
Pri bolnikih z demenco v povezavi s Parkinsonovo boleznijo so opazili poslabšanje (ki vključuje bradikinezijo, diskinezijo in motnje drže) in povečano pojavnost in intenzivnost tremorja
Attaching the syringe to the bottle • Push the nozzle of the syringe into the hole in the white stopper.
• • Nastavek brizge vstavite v odprtino belega zamaška.
Frequency categories are defined using the following convention: very common
klasifikaciji in glede na kategorijo pogostnosti.
Weight loss
Polnjenje brizge
• Sweating
• hujšanje
Elevated liver function tests Hepatitis
Bolezni jeter, žolčnika in žolčevodov občasni pogostnost neznana zvišani jetrni funkcijski testi hepatitis
• Uneven heartbeat
• neredno bitje srca
According to its metabolism, metabolic interactions with other medicinal products appear unlikely, although rivastigmine may inhibit the butyrylcholinesterase mediated metabolism of other substances.
Glede na njegovo presnovo se zdi presnovno medsebojno delovanje z drugimi zdravili malo verjetno,
(n=165) n/a
(N=165)
Sodium benzoate Citric acid
- Pomožne snovi so natrijev benzoat, citronska kislina, natrijev citrat, kinolinsko rumeno WS
Uncommon Not known
ni podatka ni podatka
• Weight loss
• vrtoglavost
A mild eye/mucosal irritation potential of rivastigmine was identified in a rabbit study.
V študiji pri kuncih so ugotovili, da ima rivastigmin potencial za blago draženje oči/sluznic.
EMA/760429/2012 corr. EMEA/H/C/001048
EMA/799912/2012 EMEA/H/C/001048
The European Commission granted a marketing authorisation valid throughout the European Union for Jalra on 19 November 2008.
Evropska komisija je dovoljenje za promet z zdravilom Jalra, veljavno po vsej Evropski uniji, odobrila dne 19. novembra 2008.
Its use in patients with heart disease should be limited to patients with mild disease.
Njegova uporaba pri bolnikih z obolenjem srca mora biti omejena na bolnike z blagim obolenjem.
The full EPAR for Jalra can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Jalra je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This is a summary of the European public assessment report (EPAR) for Jalra.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Jalra.
In adults, the recommended dose of Jalra is:
Pri odraslih priporočeni odmerek zdravila Jalra znaša:
What benefit has Jalra shown during the studies?
Kakšne koristi je zdravilo Jalra izkazalo med študijami?
For more information about treatment with Jalra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Jalra si preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujete z zdravnikom ali farmacevtom.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Jalra.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Jalra, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The active substance in Jalra, vildagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Zdravilna učinkovina v zdravilu Jalra, vildagliptin, je zaviralec dipeptidil peptidaze 4 (DPP-4).
The most common side effect with Jalra (seen in between 1 and 10 patients in 100) is dizziness.
Najpogostejši neželeni učinek zdravila Jalra (opažen pri 1 do 10 bolnikih izmed 100) je omotica.
Other information about Jalra
Druge informacije o zdravilu Jalra
Jalra is a medicine that contains the active substance vildagliptin.
Jalra je zdravilo, ki vsebuje zdravilno učinkovino vildagliptin.
Jalra must not be used in people who are hypersensitive (allergic) to vildagliptin or any of the other ingredients.
Zdravila Jalra ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) vildagliptin ali katero koli drugo sestavino zdravila.
Jalra is not recommended for patients who have moderate or severe problems with their kidneys, including those on haemodialysis (a blood clearance technique) with end-stage renal disease.
Zdravilo Jalra ni priporočljivo za bolnike, ki imajo zmerne ali hude težave z ledvicami, vključno z bolniki na hemodializi (tehniki čiščenja krvi) s končno ledvično odpovedjo.
Jalra should therefore be used only in patients for whom metformin is inappropriate either because of side effects occurring with metformin or because they have a condition that makes metformin unsuitable for them.
Zdravilo Jalra naj bi torej uporabljali samo bolniki, za katere metformin ni primeren bodisi zaradi neželenih učinkov, ki se pojavijo zaradi jemanja metformina, bodisi ker imajo bolezen, pri kateri jemanje metformina zanje ni ustrezno.
Jalra has been studied in eleven main studies involving a total of over 5,000 patients with type 2 diabetes and insufficient control of blood glucose levels.
Zdravilo Jalra so proučevali v 11 glavnih študijah, v katere je bilo vključenih skupno več kot 5 000 bolnikov s sladkorno boleznijo tipa 2, pri katerih koncentracija glukoze v krvi ni bila zadostno uravnana.
Why has Jalra been approved?
Zakaj je bilo zdravilo Jalra odobreno?
Because vildagliptin has been associated with liver problems, patients should have tests to check their liver function before treatment with Jalra and at regular intervals during treatment.
Ker vildagliptin povezujejo z okvaro jeter, morajo bolniki pred začetkom zdravljenja z zdravilom Jalra opraviti preiskave jeter in nato v rednih presledkih med zdravljenjem.
The CHMP also considered the use of Jalra on its own and concluded that it was effective in reducing blood glucose but was less effective than metformin.
CHMP je proučil tudi samostojno uporabo zdravila Jalra in zaključil, da je sicer učinkovito pri zniževanju glukoze v krvi, a manj kot metformin.
Jalra is not recommended for patients with liver problems.
Zdravilo Jalra ni priporočljivo za bolnike z okvaro jeter.
What is the risk associated with Jalra?
Kakšna tveganja so povezana z zdravilom Jalra?
For the full list of all side effects reported with Jalra, including side effects occurring when Jalra is taken with other antidiabetes medicines, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Jalra, vključno z neželenimi učinki, ki se pojavijo, kadar se zdravilo Jalra jemlje z drugimi zdravili proti sladkorni bolezni, glejte navodilo za uporabo.