natgillin/translations-raw huggingface dataset:
For schizophrenia, the recommended starting dose is 10 or 15 mg per day in adults, followed by a ‘maintenance' dose of 15 mg once a day.
Pri shizofreniji je priporočeni začetni odmerek pri odraslih 10 ali 15 mg na dan, ki mu sledi „vzdrževalni odmerek“ v višini 15 mg enkrat na dan.
Aripiprazole Accord is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.
Zdravilo se uporablja do največ 12 tednov tudi za zdravljenje zmernih do hudih maničnih epizod pri bolnikih, starejših 13 let.
In patients aged between 15 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Pri bolnikih, starih od 15 do 17 let, je začetni odmerek 2 mg na dan (pri čemer se uporablja zdravilo z aripiprazolom v tekoči obliki), postopoma pa se povečuje na priporočeni odmerek 10 mg enkrat na dan.
Why is Aripiprazole Accord approved?
Zakaj je bilo zdravilo Aripiprazol Accord odobreno?
For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Za zdravljenje maničnih epizod pri bolnikih, starih od 13 do 17 let, je začetni odmerek 2 mg na dan (pri čemer se uporablja zdravilo z aripiprazolom v tekoči obliki), ki se postopoma povečuje na priporočeni odmerek 10 mg enkrat na dan. Zdravljenje ne sme biti daljše od 12 tednov.
How is Aripiprazole Accord used?
Kako se zdravilo Aripiprazol Accord uporablja?
How does Aripiprazole Accord work?
Kako zdravilo Aripiprazol Accord deluje?
How has Aripiprazole Accord been studied?
Kako je bilo zdravilo Aripiprazol Accord raziskano?
Further information on Remicade can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Remicade.
Nadaljnje informacije o zdravilu Remicade so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Remicade.
Remicade received a marketing authorisation valid throughout the EU on 13 August 1999.
Za zdravilo Remicade je bilo 13. avgusta 1999 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
What measures are being taken to ensure the safe and effective use of Remicade?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Remicade?
The European Medicines Agency decided that Remicade's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Remicade večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The effects of adding Remicade to existing treatment have also been studied in 103 children and adolescents with Crohn's disease who were aged between 6 and 17 years.
Učinke dodajanja zdravila Remicade obstoječemu zdravljenju so proučevali tudi pri 103 otrocih in mladostnikih s Crohnovo boleznijo, starih od šest do 17 let.
Other information about Remicade
Druge informacije o zdravilu Remicade
Patients who receive Remicade must be given a special reminder card.
Bolniki, ki prejemajo zdravilo Remicade, morajo prejeti posebno opozorilno izkaznico.
As for all medicines, data on the use of Remicade are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Remicade stalno spremljajo.
Remicade is usually given as 3 mg per kilogram body weight in rheumatoid arthritis, although the dose can be increased if necessary.
Zdravilo Remicade se pri revmatoidnem artritisu običajno daje v odmerku 3 mg na kilogram telesne mase, vendar se odmerek po potrebi lahko poveča.
What benefits of Remicade have been shown in studies?
Kakšne koristi je zdravilo Remicade izkazalo v študijah?
Why is Remicade authorised in the EU?
Zakaj je zdravilo Remicade odobreno v EU?
The dose is 5 mg per kilogram for the other diseases.
Za zdravljenje drugih bolezni znaša odmerek 5 mg na kilogram telesne mase.
A sixth study in 508 adult patients looked at the number of patients whose symptoms improved and who did not need additional treatment with corticosteroids (other medicines used in Crohn's disease).
Šesta študija je pri 508 odraslih bolnikih beležila število bolnikov, pri katerih so se simptomi izboljšali in ki niso potrebovali dodatnega zdravljenja s kortikosteroidi (drugimi zdravili za zdravljenje Crohnove bolezni).
What is Remicade and what is it used for?
Kaj je zdravilo Remicade in za kaj se uporablja?
Remicade is also used in patients aged between 6 and 17 years with severe, active Crohn's disease or severely active ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.
Zdravilo Remicade se uporablja tudi pri bolnikih v starosti med šest in 17 let z resno, aktivno Crohnovo boleznijo ali resnim, aktivnim ulceroznim kolitisom, kadar se na drugo zdravljenje ali zdravila niso odzvali ali kadar jih ne smejo prejemati.
What are the risks associated with Remicade?
Kakšna tveganja so povezana z zdravilom Remicade?
An overview of Remicade and why it is authorised in the EU
Pregled zdravila Remicade in zakaj je odobreno v EU
In a study with 60 children aged between 6 and 17 years with ulcerative colitis 73% of patients responded to treatment with Remicade at week eight (44 out of 60).
V študiji s 60 otroki, starih od šest do 17 let, z ulceroznim kolitisom se je po osmem tednu na zdravljenje z zdravilom Remicade odzvalo 73 % (44 od 60) bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Remicade have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Remicade upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The most common side effects with Remicade (seen in more than 1 patient in 10) are viral infections (such as flu or cold sores), headache, upper respiratory tract infection (colds), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain.
Najpogostejši neželeni učinki zdravila Remicade (opaženi pri več kot enem bolniku od 10) so virusne okužbe (na primer gripa ali herpes), glavobol, okužbe zgornjih dihal (prehladi), sinusitis (vnetje sinusov), navzeja (slabost), bolečine v trebuhu, reakcije, povezane z infuzijo, in bolečine.
Side effects reported with Remicade are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Remicade, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
For more information about using Remicade, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Remicade glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Most of the patients showed a reduction in symptoms after adding Remicade to their existing treatment.
Pri večini bolnikov je bilo opaziti zmanjšanje simptomov po dodajanju zdravila Remicade obstoječemu zdravljenju.
In Crohn's disease in adults, Remicade was compared with placebo (a dummy treatment) in 1,090 adults in four studies.
Pri Crohnovi bolezni so zdravilo Remicade primerjali s placebom (zdravilom brez zdravilne učinkovine) pri 1 090 odraslih v štirih študijah.
Remicade must not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).
Zdravilo Remicade se ne sme uporabljati pri bolnikih s tuberkulozo, drugimi hudimi okužbami ali zmernim do hudim srčnim popuščanjem (stanjem, pri katerem srce ne zmore prečrpavati dovolj krvi skozi telo).
Remicade has been studied in a total of 1,432 patients with rheumatoid arthritis in two studies.
Zdravilo Remicade so pri zdravljenju revmatoidnega artritisa proučevali v dveh študijah s skupno 1 432 bolniki.
The active substance in Remicade, infliximab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Učinkovina v zdravilu Remicade, infliksimab, je monoklonsko protitelo, tj. vrsta beljakovine, ki je bila zasnovana tako, da prepozna določeno strukturo (imenovano antigen) v telesu in se veže nanjo.
To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Remicade or the infusion time may be slowed down.
Za zmanjšanje tveganja za pojav reakcij, povezanih z infundiranjem, utegnejo bolniki pred zdravljenjem z zdravilom Remicade ali med njim prejemati druga zdravila ali pa se čas infundiranja upočasni.
Remicade must not be used in patients who have experienced hypersensitivity (allergy) to infliximab in the past, or who are hypersensitive (allergic) to mouse proteins or any of the other ingredients of Remicade.
Zdravila Remicade ne smejo uporabljati osebe, pri katerih je v preteklosti prišlo do preobčutljivosti (alergije) na infliksimab, ali pri tistih, ki so preobčutljivi za (alergični na) na mišje beljakovine ali katero koli drugo sestavino zdravila Remicade.
It is usually used when other medicines or treatments have failed, in adults with the following diseases:
Navadno se uporablja pri odraslih z naslednjimi obolenji, kadar druga zdravila ali zdravljenja niso bila učinkovita:
Ulcerative colitis, ankylosing spondylitis and psoriatic arthritis For ulcerative colitis (728 adults), ankylosing spondylitis (70 adults) and psoriatic arthritis (104 adults), Remicade has been compared with placebo.
Pri ulceroznem kolitisu (728 bolnikov), ankilozirajočem spondilitisu (70 bolnikov) in psoriatičnem artritisu (104 bolniki) so zdravilo Remicade primerjali s placebom.
The patients were treated for 6 months with Remicade, another medicine azathioprine, or the combination of Remicade and azathioprine.
Bolnike so šest mesecev zdravili z zdravilom Remicade, azatioprinom (drugim zdravilom) ali s kombinacijo zdravila Remicade in azatioprina.
The card will include safety information about the medicine and a record of the dates and results of specific tests that the patient has had so these can be shared with any treating doctor.
Na njej so povzeti podatki o varnosti zdravila ter evidenca datumov in rezultatov posebnih preizkusov, ki jih je bolnik moral opraviti, ki se lahko dajo na vpogled lečečemu zdravniku.
In these studies Remicade produced a greater improvement in symptoms, led to fistulae healing in more patients and increased the time that patients continued to respond to treatment.
V teh študijah je zdravilo Remicade v primerjavi s placebom privedlo do večjega izboljšanja simptomov, ozdravljenja fistul pri večjem številu bolnikov ter podaljšalo čas odzivanja bolnikov na zdravljenje.
Remicade alone and in combination with azathioprine was more effective than azathioprine alone.
Zdravilo Remicade kot samostojno zdravilo in v kombinaciji z azatioprinom je bilo učinkovitejše od samostojnega zdravljenja z azatioprinom.
In a study in 627 adults with psoriasis, Remicade led to a greater improvement in symptoms than placebo.
V študiji, v katero je bilo vključenh 627 odraslih s psoriazo, je zdravilo Remicade v primerjavi s placebom privedlo do večjega izboljšanja simptomov.
Remicade can only be obtained with a prescription and must be given under the supervision and monitoring of a specialised doctor who has experience in the diagnosis and treatment of the diseases that Remicade can be used to treat.
Predpisovanje in izdaja zdravila Remicade je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolezni, za katere se to zdravilo uporablja.
• Crohn's disease (a disease causing inflammation of the digestive tract), when the disease is moderate to severe or fistulising (with the formation of fistulae, abnormal passageways between the gut and other organs);
• Crohnovo boleznijo (obolenjem, ki povzroča vnetje prebavnega trakta), kadar je obolenje zmerno do močno izraženo ali pa prihaja do fistulizacije (s pojavljanjem fistul, tj. nenormalnih prehodov med črevesjem in drugimi organi);
Remicade is used with methotrexate (a medicine that acts on the immune system);
Zdravilo Remicade se uporablja skupaj z metotreksatom (zdravilom, ki učinkuje na imunski sistem);
In these studies, more patients taking Remicade in combination with methotrexate showed a reduction in symptoms than those taking methotrexate alone, as well as less damage to the joints and greater improvements in physical function.
V teh študijah je do zmanjšanja simptomov prišlo pri večjem številu bolnikov, ki so zdravilo Remicade prejemali skupaj z metotreksatom, kot pri bolnikih, ki so prejemali samo metotreksat, manj je bilo tudi poškodb v sklepih in opaženo večje izboljšanje telesne zmogljivosti.
This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Remicade is used to treat.
Ta prenašalec sodeluje pri povzročanju vnetja in ga je mogoče v velikih koncentracijah najti pri bolnikih z obolenji, za zdravljenje katerih se uporablja zdravilo Remicade.
Remicade is an anti-inflammatory medicine.
Zdravilo Remicade je protivnetno zdravilo.
More adult patients receiving Remicade had a reduction in symptoms than those receiving placebo.
Zmanjšanje simptomov je bilo opaziti pri več odraslih bolnikih, ki so prejemali zdravilo Remicade, kot pri tistih, ki so prejemali placebo.
Remicade is available as a powder that is made up into a solution for infusion (drip into a vein).
Zdravilo Remicade je na voljo je v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije v veno).
For the full list of side effects of Remicade, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Remicade, glejte navodilo za uporabo.
Remicade contains the active substance infliximab.
Zdravilo Remicade vsebuje učinkovino infliksimab.
• psoriasis (a disease causing red, scaly patches on the skin).
• psoriazo (boleznijo, ki povzroča rdeče, luskaste zaplate na koži).
How is Remicade used?
Kako se zdravilo Remicade uporablja?
• rheumatoid arthritis (an immune system disease causing inflammation of the joints).
• revmatoidnim artritisom (boleznijo imunskega sistema, ki povzroča vnetje sklepov).
Remicade is given as an infusion lasting one or two hours.
Zdravilo Remicade se daje v obliki eno- ali dvourne infuzije.
• ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine);
• ankilozirajočim spondilitisom (boleznijo, ki povzroča vnetje in bolečine v sklepih v hrbtenici);
• psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
• psoriatičnim artritisom (boleznijo, ki povzroča nastajanje rdečih in luskinastih zaplat na koži in vnetje sklepov);
(Invented) name Strength
(Izmišljeno) ime
Date of first authorisation: 23 April 2014 Date of latest renewal: 18 December 2018
Datum prve odobritve: 23. april 2014 Datum zadnjega podaljšanja: 18. december 2018
Some patients had more than one amputation.
Nekateri bolniki so imeli več kot eno amputacijo.
The mean age was 63 years and 64% were male.
Povprečna starost je bila 63 let, 64% je bilo moških.
Vital status was obtained for 99.6% of subjects across the studies.
Podatke o vitalnem statusu so v okviru obeh študij pridobili pri 99,6% preiskovancev.
Take the medicine pack with you.
Škatlo z zdravilom vzemite s seboj.
• If you forget to take a dose, take it as soon as you remember.
• Če ste pozabili vzeti odmerek, ga vzemite takoj, ko se spomnite.
Not known (freqency cannot be estimated from the available data)
Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
• if you drink alcohol to excess (either every day or from time to time)
• če prekomerno uživate alkohol (bodisi vsakodnevno ali samo občasno)
Do not store above 30°C.
Shranjujte pri temperaturi do 30C.
The percentage of minor and major amputations is based on the highest level amputation for each patient.
Odstotek manjših in večjih amputacij temelji na največji ravni amputacije pri posameznem bolniku.
• about what you can do to prevent dehydration (see section 4 for signs of dehydration).
• kaj lahko storite, da boste preprečili dehidracijo (glejte poglavje 4 za znake dehidracije).
The mean Vd ranged between 63-276 litres.
Povprečni Vd je znašal 63-276 litrov.
Note: Incidence is based on the number of patients with at least one amputation, and not the total number of amputation events.
Opomba: Incidenca temelji na številu bolnikov z najmaj eno amputacijo in ne na celotnem številu amputacij.
A patient's follow-up is calculated from Day 1 to the first amputation event date.
Trajanje spremljanja bolnika je računano od 1. dne v študiji do datuma prve amputacije.
17% of patients were Hispanic.
17% bolnikov je bilo latinskoameriškega izvora.
In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
Pri bolnikih s povečanim tveganjem dodatnega napredovanja okvare ledvic in pri starejših je treba delovanje ledvic oceniti pogosteje, na primer vsake 3--6 mesecev.
canagliflozin N = 5,790
kanagliflozin N = 5.790
The effect of being homozygote (UGT1A9*3/*3, frequency < 0.1%) is probably more marked, but has not been investigated.
Verjetno je učinek večji, če je posameznik homozigot (UGT1A9*3/*3, pogostnost < 0,1%), vendar tega niso preiskovali.
Severe allergic reaction (rare, may affect up to 1 in 1,000 people) Possible signs of severe allergic reaction may include:
Huda alergijska reakcija (redko, pojavi se lahko pri največ 1 od 1.000 bolnikov) Možni znaki hude alergijske reakcije lahko vključujejo:
The amputation results for the Integrated CANVAS Program are shown in table 2.
Z amputacijami povezani rezultati v integriranem programu CANVAS so prikazani v preglednici 2.
However, if it is time for the next dose, skip the missed dose.
Če pa je že čas za naslednji odmerek, izpustite pozabljeni odmerek.
Vokanamet is not recommended for children and adolescents under 18 years, because data are not available in these patients.
Pri otrocih in mladostnikih, ki so stari manj kot 18 let, uporaba zdravila Vokanamet ni priporočljiva, ker ni razpoložljivih podatkov o uporabi pri teh bolnikih.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking or continuing to take this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo ali preden nadaljujete z jemanjem tega zdravila.
• if you have type 1 diabetes because Vokanamet should not be used to treat this condition.
• če imate sladkorno bolezen tipa 1, saj se za zdravljenje te bolezni zdravila Vokanamet ne sme uporabljati.
Component of a 3 bottle multipack, can not be sold separately.
Sestavni del skupnega pakiranja s 3 škatlami, ki se jih ne sme izdajati posamezno.
What Vokanamet is and what it is used for
Kaj je zdravilo Vokanamet in za kaj ga uporabljamo
An eGFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter.
Vrednost eGFR je treba oceniti pred uvedbo zdravljenja z zdravili, ki vsebujejo metformin, nato pa vsaj enkrat letno.
As an underlying mechanism has not been established, risk factors, apart from general risk factors, for amputation are unknown.
Osnovnega mehanizma niso ugotovili, zato dejavniki tveganja za amputacije (razen splošnih dejavnikov tveganja) niso znani.
• Swallow the tablet whole with water.
• Tableto pogoltnite celo skupaj z vodo.
As precautionary measures, consideration should be given to carefully monitoring patients with a higher risk for amputation events and counselling patients about the importance of routine preventative foot care and maintaining adequate hydration.
Iz previdnosti je treba razmisliti o skrbnem spremljanju bolnikov z večjim tveganjem za dogodke, ki vodijo do amputacije, in opozarjanju bolnikov na pomembnost rutinske preventivne nege stopal in vzdrževanja zadostne hidracije.
Treatment with Vokanamet may be restarted when the ketone values are normal and the patient's condition has stabilised.
Zdravljenje z zdravilom Vokanamet je mogoče ponovno uvesti, ko so vrednosti ketonov normalne is se bolnikovo stanje stabilizira.
Patients in CANVAS and CANVAS-R were followed for an average of 5.7 and 2.1 years, respectively.
Bolnike v študijah CANVAS in CANVAS-R so v povprečju spremljali 5,7 oziroma 2,1 let.
• in muscle, by increasing insulin sensitivity, improving peripheral glucose uptake and utilisation
• v mišicah poveča občutljivost za insulin, izboljša periferni privzem in koriščenje glukoze
• swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing.
• otekanje obraza, ustnic, ust, jezika, grla, zaradi česar je lahko oteženo dihanje ali požiranje.
Patients had an overall mean age of 59.5 years (range 21 years to 96 years), with 3,135 patients ≥ 65 years of age and 513 patients ≥ 75 years of age.
Povprečna starost vseh bolnikov je bila 59,5 let (od 21 do 96 let), pri čemer je bilo 3.135 bolnikov starih najmanj 65 let, 513 bolnikov pa najmanj 75 let.
Secondary endpoints within a sequential conditional hypothesis testing were all-cause mortality and cardiovascular mortality.
Sekundarna opazovana dogodka s sekvenčnim pogojnim testiranjem hipotez sta bila umrljivost iz kateregakoli vzroka in kardiovaskularna umrljivost.
These studies were multicenter, multi-national, randomised, double-blind, parallel group, with similar inclusion and exclusion criteria and patient populations.
Gre za multicentrični, mednarodni, randomizirani, dvojno slepi študiji z vzporedno primerjavo zdravljenih skupin, ki imata med seboj podobne vključitvene in izključitvene kriterije in zajemata podobni populaciji bolnikov.
Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption, which may very rarely result in clinically significant vitamin B12 deficiency (e.g., megaloblastic anaemia).
Dolgotrajno zdravljenje z metforminom je povezano z zmanjšanjem absorpcije vitamina B12, kar pa le zelo redko povzroči klinično pomembno pomanjkanje vitamina B12 (npr. megaloblastno anemijo).
All-cause mortality
Umrljivost iz kateregakoli vzroka
What you need to know before you take Vokanamet
Kaj morate vedeti, preden boste vzeli zdravilo Vokanamet
Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away (see section 2).
Takoj prenehajte jemati to zdravilo in nemudoma obvestite zdravnika ali koga v najbližji bolnišnici (glejte poglavje 2).
Active-controlled studies
Študije nadzorovane z učinkovino
In addition, in such patients greater decreases in eGFR were reported (see sections 4.2 and 4.8).
Poleg tega so pri teh bolnikih poročali tudi o večjem zmanjšanju eGFR (glejte poglavji 4.2 in 4.8).
The maximum daily dose of metformin should preferably be divided into 2-3 daily doses.
Najbolje je, da se največji dnevni odmerek metformina je razdeli v 2-3 dnevne odmerke.
Necrotising fasciitis of the perineum (Fournier's gangrene)
Nekrotizirajoči fasciitis presredka(Fournierova gangrena)
Sixty-six percent of subjects had a history of established cardiovascular disease, with 56% having a history of coronary disease, 19% with cerebrovascular disease, and 21% with peripheral vascular disease; 14% had a history of heart failure.
Šestinšestdeset odstotkov preiskovancev je imelo v anamnezi ugotovljeno kardiovaskularno bolezen, pri čemer jih je imelo 56% v anamnezi koronarno bolezen, 19% cerebrovaskularno bolezen in 21% bolezen perifernega žilja, 14% pa jih je imelo v anamnezi srčno popuščanje.