natgillin/translations-raw huggingface dataset:
General disorders and administration site conditions very common influenza like illness, fatigue common pyrexia, injection site reaction, asthenia, chills, general physical health deterioration, injection site erythema uncommon injection site pain, injection site pruritus, sensitivity to weather change not known:
Splošne težave in spremembe na mestu aplikacije zelo pogosti gripi podobna bolezen, utrujenost pogosti pireksija, reakcija na mestu injiciranja, astenija, mrzlica,
Ropeginterferon alfa-2b treatment arm (n=127)
Značilnosti bolnikov ob presejanju v študiji PROUD-PV Skupina, zdravljenja z ropeginterferonom alfa-2b (n = 127)
Description Besremi 250 micrograms pre-filled pen
Opis napolnjenega injekcijskega peresnika zdravila Besremi 250 mikrogramov
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b
Besremi 250 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku ropeginterferon alfa-2b
The recommended injection site is the abdominal skin around but not within 5 cm of the navel or the thigh.
Priporočeno mesto injiciranja je koža na trebuhu, ki mora biti od popka ali stegna oddaljena najmanj 5 cm. Ne injicirajte v predele, kjer je koža razdražena, pordela, podpluta, okužena ali brazgotinasta.
Please read this leaflet carefully before using the Besremi 250 micrograms pre-filled pen.
Navodila za uporabo Pred uporabo zdravila Besremi 250 mikrogramov napolnjen injekcijski peresnik natančno preberite to navodilo.
Liver enzymes and hepatic function should be regularly controlled in patients with longterm ropeginterferon alfa-2b therapy.
Pri bolnikih na dolgotrajnem zdravljenju z ropeginterferonom alfa-2b je treba redno spremljati jetrne encime in delovanje jeter.
Ask your doctor or pharmacist for advice: - if you are pregnant or breast-feeding.
Zdravnika ali farmacevta vprašajte za nasvet:
Increased liver enzyme levels have been observed in patients treated with ropeginterferon alfa-2b.
Pri bolnikih, ki so jih zdravili z ropeginterferonom alfa-2b, so opazili zvišane ravni jetrnih encimov.
In the clinical development program of ropeginterferon alfa-2b, two cases of serious depression (1.1%; incidence rate: 0.4 events/100 patients per year) occurred.
V programu kliničnega razvoja ropeginterferona alfa-2b je prišlo do 2 primerov resne depresije (1,1
Liver disorders have been reported in patients after long-term ropeginterferon alfa-2b therapy (see section 4.8).
Po dolgotrajnem zdravljenju z ropeginterferonom alfa-2b so pri bolnikih poročali o boleznih jeter (glejte poglavje 4.8).
Each pre-filled pen of 0.5 mL solution contains 500 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 1,000 micrograms/mL.
En napolnjen injekcijski peresnik z 0,5 ml raztopine vsebuje 500 mikrogramov ropeginterferona alfa-2b, merjeno glede na beljakovine, kar ustreza 1.000 mikrogramom/ml.
Patients who develop symptoms indicative of a thyroid dysfunction during ropeginterferon alfa-2b therapy, should evaluate their thyroid stimulating hormone (TSH) levels.
Bolnikom, ki se jim med zdravljenjem z ropeginterferonom alfa-2b pojavijo simptomi, ki kažejo na okvaro delovanja ščitnice,
Enzymes of the protein catabolism are considered to be involved in the metabolism of ropeginterferon alfa-2b.
V presnovo ropeginterferona alfa-2b so domnevno vpleteni encimi, ki opravljajo razgradnjo beljakovin.
OTHER
onihomikoza
Water for injections
Shranjevanje zdravila Besremi
Each pre-filled pen of 0.5 mL solution contains 250 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 500 micrograms/mL.
En napolnjen injekcijski peresnik z 0,5 ml raztopine vsebuje 250 mikrogramov ropeginterferona alfa-2b, merjeno glede na beljakovine, kar ustreza 500 mikrogramom/ml.
The pharmacokinetic profile of other interferon alfa medicinal products (pegylated interferon alfa-2a and pegylated interferon alfa-2b) was evaluated in renal impaired patients (see section 5.2).
(pegilirani interferon alfa-2a in pegilirani interferon alfa-2b) (glejte poglavje 5.2).
Very common side effects (may affect more than 1 in 10 people): - decrease in the number of a type of white blood cells (called leucocytes) and in blood clotting cells (called platelets) - joint or muscle pain - flu-like symptoms, feeling tired - in blood tests: increase of an enzyme called gamma-glutamyltransferase
- zmanjšanje števila vrste belih krvnih celic (imenovanih levkociti) in celic, ki pomagajo pri strjevanju krvi (imenovanih trombociti), - bolečina v sklepih in mišicah,
A reduced starting dose for ropeginterferon alfa-2b of 50 micrograms is recommended for patients with severe (GFR 1529 mL/min) renal impairment.
29 ml/min) je priporočljivo zmanjšanje začetnega odmerka ropeginterferona alfa-2b na 50 mikrogramov.
Other CNS effects,
- suhe oči,
Rare side effects (may affect up to 1 in 1,000 people): - bipolar disorders (mood disorders with episodes of sadness and excitement), mania (extreme excitement or unreasonable enthusiasm) - cardiomyopathy (diseases that affect the heart muscle), angina pectoris (a severe chest pain as a result of blockage of the heart vessels) - liver failure
- bipolarna motnja (spremembe razpoloženja z epizodami žalosti in navdušenja), manija (ekstremno navdušenje ali nerazumljiv entuziazem),
Clear, colourless to pale yellow solution.
raztopina za injiciranje v napolnjenem injekcijskem peresniku (injekcija) Bistra, brezbarvna do bledo rumena raztopina.
The pharmacokinetic profile of ropeginterferon alfa-2b has not been determined in obese and underweighted patients.
Pri prekomerno prehranjenih ali podhranjenih bolnikih farmakokinetičnega profila ropeginterferona alfa-2b niso ovrednotili.
No n (%)
Izboljšanje n (%)
• Remove the cap from the pen.
• S peresnika odstranite pokrovček.
If you use more Besremi than you should
Če ste uporabili večji odmerek zdravila Besremi, kot bi smeli Čim prej obvestite zdravnika.
Comparable exposure and pharmacokinetic profile was reported for another interferon alfa medicinal product (pegylated interferon alfa-2a) in cirrhotic (Child-Pugh A) and non-cirrhotic patients.
Pri drugem zdravilu z interferonom alfa (pegiliran interferon alfa-2a) so pri bolnikih s cirozo (Child
Studies in rats with a similar interferon alfa medicinal product (pegylated interferon alfa-2a) showed a primarily elimination via hepatic metabolism.
(pegiliran interferon alfa-2a) so pokazale primarno izločanje s presnovo v jetrih.
This overview was last updated in 02-2019.
Pregled je bil nazadnje posodobljen 02-2019.
It is used to treat the following diseases:
Uporablja se za zdravljenje naslednjih bolezni:
Further information on Simponi can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/simponi.
Nadaljnje informacije o zdravilu Simponi so na voljo na spletni strani agencije: ema.europa.eu/en/medicines/human/EPAR/simponi.
It can be used alone or in combination with methotrexate;
Lahko se uporablja samostojno ali v kombinaciji z metotreksatom;
This was assessed after 6 weeks in the first study and after 54 weeks in the second study.
To je bilo v prvi študiji ocenjeno po šestih tednih, v drugi pa po 54 tednih.
What measures are being taken to ensure the safe and effective use of Simponi?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Simponi?
Simponi received a marketing authorisation valid throughout the EU on 1 October 2009.
Za zdravilo Simponi je bilo 1. oktobra 2009 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency decided that Simponi's benefits are greater than its risks and that it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Simponi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The main measure of effectiveness was the number of patients who responded to treatment, based on the number and severity of symptoms.
Glavno merilo učinkovitosti je bilo število bolnikov, ki so se odzvali na zdravljenje, in je temeljilo na številu in resnosti simptomov.
Other information about Simponi
Druge informacije o zdravilu Simponi
Why is Simponi authorised in the EU?
Zakaj je zdravilo Simponi odobreno v EU?
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body.
Monoklonsko protitelo je protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna posebno strukturo v telesu (imenovano antigen), in se veže nanjo.
What are the risks associated with Simponi?
Kakšna tveganja so povezana z zdravilom Simponi?
An overview of Simponi and why it is authorised in the EU
Pregled zdravila Simponi in zakaj je odobreno v EU
This study also showed that patients who received Simponi had greater improvements in carrying out everyday tasks (such as dressing, eating and walking) after 24 weeks.
Ta študija je tudi pokazala, da se je pri bolnikih, ki so prejemali zdravilo Simponi, sposobnost opravljanja vsakodnevnih opravil (kot so oblačenje, hranjenje in hoja) znatno izboljšala.
Simponi 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 Simponi se ne sme uporabljati pri bolnikih s tuberkulozo, drugimi hudimi okužbami ali zmernim do hudim srčnim popuščanjem (nezmožnostjo srca, da črpa dovolj krvi po telesu).
As for all medicines, data on the use of Simponi is continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Simponi stalno spremljajo.
Treatment with Simponi and methotrexate was not compared with placebo or any other treatment.
Zdravljenja z zdravilom Simponi in metotreksatom niso primerjali s placebom ali drugim zdravljenjem.
What benefits of Simponi have been shown in studies?
Kakšne koristi je zdravilo Simponi izkazalo v študijah?
The most serious side effects include serious infections, such as sepsis (blood infection), pneumonia (lung infection), tuberculosis and infections due to fungi or yeasts, demyelinating disorders (disorders suggesting damage to the protective sheath around nerves, such as changes to vision and weak arms or legs), re-activation of hepatitis B (a disease of the liver due to infection with the hepatitis B virus), congestive heart failure (a heart disease), lupus-like syndrome, blood reactions, severe allergic reactions, vasculitis (inflammation of the blood vessels), and lymphoma and leukaemia (types of cancer of the white blood cells).
Najpogostejši resni neželeni učinki so hude okužbe, kot je sepsa (okužba krvi), pljučnica (okužba pljuč), tuberkuloza in okužbe zaradi glivic ali kvasovk, demielinizirajoče bolezni (obolenja, ki lahko poškodujejo zaščitno ovojnico okrog živcev, kot so motnje vida in šibke okončine), ponovna aktivacija hepatitisa B (obolenja jeter), kongestivno srčno popuščanje (srčno obolenje), lupusu podoben sindrom, krvne reakcije, hude alergijske reakcije, vaskulitis (vnetje krvnih žil), limfom in levkemija (vrsta raka belih krvnih celic).
By blocking TNF-α, golimumab reduces the inflammation and other symptoms of these diseases.
Golimumab z zaviranjem snovi TNF- zmanjša vnetje in druge simptome teh bolezni.
What is Simponi and what is it used for?
Kaj je zdravilo Simponi in za kaj se uporablja?
It is used in children from 2 years of age who have not responded adequately to treatment with methotrexate.
Uporablja se pri otrocih, starejših od dveh let, ki se niso ustrezno odzvali na zdravljenje z metotreksatom.
For more information about using Simponi, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Simponi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Patients treated with Simponi must be given a reminder card that summarises the safety information about the medicine and when to seek medical advice.
Bolniki, ki se zdravijo z zdravilom Simponi, morajo prejeti opozorilno kartico, na kateri so povzete informacije o varnosti zdravila in nasveti, kdaj poiskati zdravniško pomoč.
For polyarticular juvenile idiopathic arthritis, 173 patients between 2 and 18 years old who had not responded adequately to treatment with methotrexate were treated for 12 weeks with Simponi and methotrexate.
Kar zadeva poliartikularni juvenilni idiopatski artritis, so 173 bolnikov, starih od 2 do 18 let, ki se niso ustrezno odzvali na zdravljenje z metotreksatom, 12 tednov zdravili z zdravilom Simponi in metotreksatom.
Side effects reported with Simponi are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Simponi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
It can be used in adults who have not responded adequately to other treatments including methotrexate whose disease is moderate to severe, and in patients who have not previously been treated with methotrexate whose disease is severe and progressive;
Uporablja se lahko pri odraslih bolnikih, pri katerih je bil odziv na zdravljenje z drugimi zdravili, vključno z metotreksatom, nezadosten in ki imajo zmerno do hudo obliko bolezni, ter pri bolnikih, ki predhodno še niso bili zdravljeni z metotreksatom ter katerih bolezen je huda in napreduje;
The most common side effects with Simponi are upper respiratory tract infections such as infections of the nose, throat or voice box.
Najpogostejši neželeni učinki zdravila Simponi so okužbe zgornjih dihal, kot so okužbe nosu, žrela ali govornega aparata.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Simponi have also been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Simponi upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Simponi has been shown to be effective at reducing the number and severity of symptoms in patients with the conditions for which it is authorised.
Zdravilo Simponi se je izkazalo kot učinkovito pri zmanjševanju števila in resnosti simptomov pri bolnikih z boleznimi, za zdravljenje katerih je bilo odobreno.
Due to an increased risk of infection, patients taking Simponi must be monitored closely for infections, including tuberculosis, during and for up to 5 months after treatment.
Zaradi povečanega tveganja za okužbo je treba bolnike, ki prejemajo zdravilo Simponi, med zdravljenjem in do pet mesecev po njegovem zaključku skrbno opazovati zaradi morebitnih okužb, ki vključujejo tudi tuberkulozo.
Simponi is used in combination with methotrexate (a medicine that acts on the immune system).
Zdravilo Simponi se uporablja skupaj z metotreksatom (zdravilom, ki učinkuje na imunski sistem).
Simponi is available as pre-filled pens and syringes containing a solution for injection under the skin.
Zdravilo Simponi je na voljo v obliki napolnjenih injekcijskih peresnikov in brizg, ki vsebujejo raztopino za injiciranje pod kožo.
The active substance in Simponi, golimumab, is a monoclonal antibody.
Učinkovina v zdravilu Simponi, golimumab, je monoklonsko protitelo.
Simponi is used in combination with methotrexate.
Zdravilo Simponi se uporablja v kombinaciji z metotreksatom.
Data from X-rays taken before and after two years of treatment showed less joint damage in patients receiving Simponi than in those receiving placebo.
Podatki, pridobljeni z rentgenskim slikanjem pred zdravljenjem in dve leti po njem, so pokazali manj poškodb sklepov pri bolnikih, ki so jemali zdravilo Simponi, kot pri tistih, ki so prejemali placebo.
The recommended dose depends on the disease Simponi is used to treat and the response of the patient.
Priporočeni odmerek je odvisen od bolezni, za zdravljenje katere se zdravilo Simponi uporablja, in bolnikovega odziva.
Patients should show this card when seeing a healthcare professional, so that they are aware that the patient is using Simponi.
To kartico morajo pokazati zdravstvenemu delavcu in ga s tem seznanijo, da bolnik uporablja zdravilo Simponi.
Golimumab has been designed to attach to and block a substance in the body called tumour necrosis factor alpha (TNF-α).
Golimumab je bil zasnovan tako, da se v telesu veže na snov, imenovano tumorje nekrozitirajoči faktoralfa (TNF-), in jo zavira.
Simponi can only be obtained with a prescription and treatment must be initiated and supervised by a qualified doctor who has experience in the diagnosis and treatment of the diseases that Simponi is used to treat.
Predpisovanje in izdaja zdravila Simponi 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 zdravilo Simponi uporablja.
Of these patients, 87% of (151 out of 173) had 30% reduction in the number and severity of symptoms after 16 weeks.
Pri 87 % (151 od 173) od teh bolnikov je po 16 tednih prišlo do 30-odstotnega zmanjšanja števila in resnosti simptomov.
This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Simponi is used to treat.
Ta snov sodeluje pri nastanku vnetij in je v visokih koncentracijah prisotna pri bolnikih z boleznimi, za zdravljenje katerih se uporablja zdravilo Simponi.
Simponi is an anti-inflammatory medicine.
Zdravilo Simponi je protivnetno zdravilo.
The first study, involving 1,065 patients, compared different doses of Simponi with placebo as induction treatment.
V prvi študiji, v katero je bilo vključenih 1 065 bolnikov, so primerjali različne odmerke zdravila Simponi s placebom kot uvodnim zdravljenjem.
For non-radiographic axial spondyloarthritis, Simponi was compared with placebo over 16 weeks in one main study involving 198 patients who had the disease without evidence of ankylosing spondylitis but with signs of inflammation and who had not responded adequately to treatment with NSAIDs.
Pri neradiografskem aksialnem spondiloartritisu so zdravilo Simponi 16 tednov primerjali s placebom v eni glavni študiji, v katero je bilo vključenih 198 bolnikov, katerih bolezen je bila brez znakov ankilozirajočega spondilitisa, toda z znaki vnetja, in pri katerih je bil odziv na zdravljenje z NSAID nezadosten.
• polyarticular juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints).
• določenih oblik juvenilnega idiopatskega artritisa (redke otroške bolezni, ki povzroča vnetje več sklepov).
• active and progressive psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
• aktivnega in napredovalega psoriatičnega artritisa (bolezni, ki povzroča nastajanje rdečih in luskinastih zaplat na koži in vnetje sklepov).
How is Simponi used?
Kako se zdravilo Simponi uporablja?
How does Simponi work?
Kako zdravilo Simponi deluje?
After training, patients may inject themselves with Simponi if their doctor agrees.
Ob soglasju zdravnika si lahko bolniki po opravljenem usposabljanju zdravilo Simponi vbrizgavajo sami.
The second study, involving 1,228 patients, compared Simponi 50 or 100 mg with placebo as maintenance treatment.
V drugi študiji, v katero je bilo vključenih 1 228 bolnikov, so 50- ali 100-miligramske odmerke zdravila Simponi primerjali s placebom kot vzdrževalnim zdravljenjem.
Simponi is used in adults who have not responded adequately to other treatments.
Zdravilo Simponi se uporablja pri odraslih, pri katerih je bil odziv na druga zdravljenja neustrezen.
• axial spondyloarthritis (a disease causing inflammation and pain in the joints of the spine), including: - adults with severe active ankylosing spondylitis who have not responded adequately to other treatments; - adults with severe non-radiographic axial spondyloarthritis (when there are objective signs of inflammation but no abnormalities seen on x-ray) who have not responded adequately or are intolerant to anti-inflammatory medicines called non-steroidal anti-inflammatory drugs (NSAIDs);
- odraslih s hudim neradiografskim aksialnim spondiloartritisom (kadar so vidni znaki vnetja, a rentgensko slikanje ni pokazalo nepravilnosti), ki se niso zadovoljivo odzvali na protivnetna zdravila, imenovana nesteroidna protivnetna zdravila (NSAID), ali jih ne prenašajo;
• moderately to severely active ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut).
• zmernega do hudega aktivnega ulceroznega kolitisa (bolezni, ki povzroča vnetje in pojavljanje razjed v črevesni sluznici).
Simponi is used in adults who have not responded adequately to, or cannot use, conventional treatment;
Zdravilo Simponi se uporablja pri odraslih bolnikih, pri katerih je bil odziv na običajno zdravljenje neustrezen ali pri katerih se običajno zdravljenje ne more uporabiti;
For rheumatoid arthritis, Simponi was compared with placebo (a dummy treatment) in three studies involving 1,542 patients with moderate to severe rheumatoid arthritis, including patients who had not received or responded adequately to other treatments.
Pri revmatoidnem artritisu so zdravilo Simponi primerjali s placebom (zdravilom brez učinkovine) v treh študijah, v katere je bilo vključenih 1 542 bolnikov z zmernim do hudim revmatoidnim artritisom, vključno z bolniki, pri katerih je bil odziv na druga zdravljenja neustrezen ali ga niso prejeli.
• active rheumatoid arthritis (a disease causing inflammation of the joints).
• aktivnega revmatoidnega artritisa (bolezni, ki povzroča vnetje sklepov).
For the full list of restrictions with Simponi, see the package leaflet.
Za celoten seznam omejitev pri uporabi zdravila Simponi glejte navodilo za uporabo.
In the first study, in which patients were also given methotrexate, after 14 weeks, 55% patients who received Simponi (49 out of 89) achieved 20% reductions compared with 33% (44 out of 133) of patients who received placebo.
V prvi študiji, v kateri so bolniki prejeli tudi metotreksat, je po 14 tednih prišlo do 20-odstotnega zmanjšanja simptomov pri 55 % (49 od 89) bolnikov, ki so prejemali zdravilo Simponi, v primerjavi s 33 % (44 od 133) bolnikov, ki so prejemali placebo.
In the first study, around 51% of patients receiving induction treatment with Simponi (starting at 200 mg) responded to treatment after 6 weeks, compared with around 30% of patients given placebo.
V prvi študiji se je po šestih tednih na zdravljenje odzvalo približno 51 % bolnikov, ki so prejemali uvodno zdravljenje z zdravilom Simponi (z začetnim 6odmerkom 200 mg), v primerjavi z okrog 30 % bolnikov, ki so prejemali placebo.
Simponi contains the active substance golimumab.
Zdravilo Simponi vsebuje učinkovino golimumab.
In the second study, around 50% of patients receiving maintenance treatment with Simponi 100 mg and around 47% of those given Simponi 50 mg responded to treatment after 54 weeks, compared with around 31% of patients given placebo.
V drugi študiji se je na zdravljenje po 54 tednih odzvalo približno 50 % bolnikov, ki so prejemali vzdrževalno zdravljenje z zdravilom Simponi v odmerku 100 mg, in okrog 47 % tistih, ki so prejemali 50-miligramski odmerek zdravila Simponi, v primerjavi s približno 31 % bolnikov, ki so prejemali placebo.
For the full list of side effects reported with Simponi, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Simponi, glejte navodilo za uporabo.
In the third study, in patients who had not been previously treated with either methotrexate or another anti-TNF-α, after 24 weeks, 40% of patients (64 out of 159) who received Simponi with methotrexate achieved 50% reductions compared with 29% of patients (47 out of 160) who received placebo and methotrexate.
V tretji študiji se je po 24 tednih pojavilo 50-odstotno zmanjšanje simptomov pri 40 % (64 od 159) bolnikov, ki predhodno še niso bili zdravljeni z metotreksatom ali drugim zaviralcem TNF- ter so prejemali zdravilo Simponi skupaj z metotreksatom, v primerjavi z 29 % (47 od 160) bolnikov, ki so prejemali placebo in metotreksat.