natgillin/translations-raw huggingface dataset:
If your doctor decides that you or a caregiver may be able to give your injections of Simponi at home, you should receive training on the right way to prepare and inject Simponi.
Če zdravnik presodi, da si lahko injekcije zdravila Simponi dajete doma sami (oziroma vam jih lahko da vaš skrbnik), morate opraviti usposabljanje za pravilno pripravo in injiciranje zdravila Simponi.
It is very important that you tell your doctor if you have ever had TB, or if you have been in close contact with someone who has had TB.
Zelo pomembno je, da poveste zdravniku, če ste imeli kadar koli v preteklosti TB ali ste bili v tesnem stiku s tuberkuloznim bolnikom.
• Flu
• gripa,
Patients in clinical remission at week 6
Bolniki v klinični remisiji v 6. tednu
The solution can be used if it contains a few small translucent or white particles of protein.
Raztopina se lahko uporablja, če vsebuje nekaj majhnih prozornih ali belih delcev beljakovin.
Appropriate screening tests, i.e. tuberculin skin or blood test and chest X-ray, should be performed in all patients (local recommendations may apply).
Pri vseh bolnikih je treba opraviti ustrezne presejalne teste, npr. tuberkulinski kožni test ali krvno preiskavo ter slikanje prsnega koša (v skladu z lokalnimi priporočili).
Use the space above to record your prescribed dose.
Poznati morate svoj odmerek V zgornji prostor vpišite svoj predpisani odmerek.
Children in this study demonstrated ACR Ped 30, 50, 70, and 90 responses from week 4.
V tej študiji so otroci že od 4. tedna pokazali odzive ACR Ped 30, 50, 70 in 90.
Patients enrolled in this study had active disease despite current or previous NSAID or DMARD therapy and had not previously been treated with anti-TNF therapy.
Bolniki, ki so bili vključeni v to študijo, so imeli aktivno bolezen kljub obstoječemu ali prejšnjemu zdravljenju z nesteroidnimi antirevmatiki ali terapijo DMARD in se pred tem niso zdravili z zaviralci TNF.
The majority of cases have occurred in adolescent and young adult males with nearly all on concomitant treatment with azathioprine (AZA) or 6-mercaptopurine (6-MP) for inflammatory bowel disease.
Večina primerov se je pojavila pri mladostnikih in mladih odraslih moškega spola, od katerih so skoraj vsi sočasno prejemali azatioprin (AZA) ali 6-merkaptopurin (6-MP) za zdravljenje vnetne črevesne bolezni.
Each pack is provided with instructions for use that fully describe the use of the pen or the syringe.
V vsakem pakiranju so navodila za uporabo, v katerih je podrobno opisana uporaba peresnika ali brizge.
The safety and efficacy of golimumab have not been established in patients with pJIA below the age of 2 years.
Varnost in učinkovitost golimumaba pri bolnikih s pJIA, mlajših od 2 let, nista bili ugotovljeni.
Patients were allowed to continue concomitant DMARD therapy with MTX, sulfasalazine (SSZ), and/or hydroxychloroquine (HCQ) during the study.
Bolnikom so dovolili, da v času študije nadaljujejo s sočasno DMARD terapijo z MTX, sulfasalazinom (SSZ) in/ali hidroksiklorokvinom (HCQ).
GO-AFTER Active RA, previously treated with one or more anti-TNF agent(s)
GO-AFTER aktiven RA, ki je bil pred tem zdravljen z enim ali več zaviralci TNF
Injection site selection for caregivers if you are not administering the injection yourself (see figure 3)
Izbira mesta za injiciranje za negovalce, če si injekcije ne dajete sami (glejte sliko 3)
The dose should be given once a month, on the same date each month.
Odmerek je treba dati enkrat na mesec, vsak mesec na isti datum.
The pharmacokinetics of golimumab were determined in 173 children with pJIA with an age range from 2 to 17 years of age.
Farmakokinetiko golimumaba so določili pri 173 otrocih s pJIA, starih od 2 do 17 let.
Simponi has not been studied in these patient populations.
Zdravilo Simponi pri teh populacijah bolnikov ni bilo raziskano.
The pen or the syringe should not be shaken.
Peresnika ali brizge se ne sme stresati.
• Wipe the injection site with an alcohol swab.
• Obrišite mesto injiciranja z alkoholnim zložencem.
• Psoriasis (including on the palms of your hand and/or the soles of your feet and/or in the form of skin blisters)
• luskavica (vključno na dlaneh in/ali podplatih in/ali v obliki mehurjev na koži),
Patients should be advised of, and avoid exposure to, potential risk factors for infection as appropriate.
Bolnike je treba ustrezno poučiti o potencialnih dejavnikih tveganja za okužbe ter o izogibanju izpostavljenosti le-tem.
Cancer and lymphoma Tell your doctor if you have ever been diagnosed with lymphoma (a type of blood cancer) or any other cancer before you use Simponi.
Rak in limfom Preden uporabite zdravilo Simponi, zdravnika obvestite, če ste kdaj imeli limfom (vrsto krvnega raka) ali kakršno koli drugo vrsto raka.
If a patient forgets to inject Simponi on the planned date, the forgotten dose should be injected as soon as the patient remembers.
Če si bolnik pozabi injicirati zdravilo Simponi na načrtovani datum, si mora pozabljeni odmerek injicirati takoj, ko se spomni.
• heart failure (rare).
• srčno popuščanje (redko).
• The yellow indicator is connected to the plunger of the pre-filled pen.
• Rumeni kazalnik je povezan z batom napolnjenega injekcijskega peresnika.
The possibility exists for TNF-blocking agents, including golimumab, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
Obstaja možnost, da bodo zaviralci TNF, vključno z golimumabom, vplivali na obrambo osebe proti okužbam in malignim boleznim, saj je TNF mediator vnetja in spremeni celični imunski odziv.
Each pack is provided with instructions for use that fully describe the use of the pen.
V vsakem pakiranju so navodila za uporabo, v katerih je podrobno opisana uporaba peresnika.
• Merkel cell carcinoma (a type of skin cancer)
• karcinom Merklovih celic (vrsta kožnega raka),
Percentage of patients Patients in clinical response at week 6
Odstotek bolnikov Bolniki s kliničnim odzivom v 6. tednu
Based on the subset of patients with ≥ 3% BSA involvement at baseline, 79 patients (69.9%) in the placebo group and 109 (74.3%) in the Simponi 50 mg group.
Na podlagi podskupine bolnikov z ≥ 3 % prizadete telesne površine (BSA) na začetku študije, 79 bolnikov (69,9 %) v skupini za prejemanje placeba in 109 (74,3 %) v skupini za prejemanje zdravila Simponi v odmerku 50 mg.
Symptoms of skin cancer can include changes in the appearance of your skin or growths on your skin.
Simptomi kožnega raka lahko vključujejo spremembe izgleda kože ali izrastke na koži.
Do not attempt to use any leftover medicine in the pre-filled pen.
Ne poskušajte uporabiti morebitnega preostanka zdravila v napolnjenem injekcijskem peresniku.
The safety and efficacy of Simponi in patients aged less than 18 for indications other than pJIA have not been established.
Varnost in učinkovitost zdravila Simponi pri bolnikih, starih manj kot 18 let, nista bili ugotovljeni za nobeno indikacijo razen za pJIA.
If possible, it is recommended that prior to initiating golimumab therapy, paediatric patients be brought up to date with all immunisations in agreement with current immunisation guidelines (see Vaccinations/therapeutic infectious agents above).
Priporočljivo je, da se pred uvedbo zdravljenja z golimumabom, če je le mogoče, pri pediatričnih bolnikih opravijo vsa cepljenja v skladu s trenutno veljavnimi smernicami za cepljenje (glejte poglavje Cepljenja/povzročitelji okužb v terapevtske namene zgoraj).
If you are not sure what to do, talk to your doctor or pharmacist.
Če niste prepričani, kaj storiti, se posvetujte z zdravnikom ali farmacevtom.
Dates of Simponi treatment
Datumi zdravljenja z zdravilom Simponi
Patients with body weight less than 80 kg
Bolniki s telesno maso manj kot 80 kg
o If you weigh more than 100 kg, the dose might be increased to 100 mg (the content of
o Če tehtate več kot 100 kg, vam bo zdravnik morda povečal odmerek na 100 mg (vsebina
Patients who completed the maintenance study through week 54 continued treatment in a study extension, with efficacy evaluated through week 216.
Bolniki, ki so do 54. tedna zaključili vzdrževalno študijo, so nadaljevali z zdravljenjem v podaljšanju študije, kjer so ocenili učinkovitost do 216. tedna.
In a developmental toxicity study conducted in mice following administration of the same analogous antibody, and in cynomolgus monkeys using golimumab, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.
V študiji vpliva na razvoj na miših z uporabo istega analognega protitelesa oziroma v študiji na opicah Cynomolgus z uporabo golimumaba ni bilo nobenih znakov toksičnosti zdravila za samice, embriotoksičnosti ali teratogenosti.
In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased mortality due to CHF have been observed.
V kliničnem preskušanju z drugim antagonistom TNF so opazili poslabšanje CHF in povečano umrljivost zaradi CHF.
• Push the open end of the pre-filled pen firmly against the skin at a 90-degree angle until the Safety Sleeve slides fully into the Clear Cover (Figure 6).
• Odprti konec napolnjenega injekcijskega peresnika močno pritisnite na kožo pod kotom 90 stopinj, dokler varnostni ovoj popolnoma ne zdrsne v prozorni ovoj (slika 6).
• Do not use this medicine after the expiry date which is stated on the label and the carton after “EXP”.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in na škatli poleg oznake "EXP".
Specific studies of golimumab have not been conducted in patients with renal or hepatic impairment.
Specifičnih študij golimumaba pri bolnikih z okvaro ledvic ali jeter niso izvedli.
The induction study (PURSUIT-Induction) evaluated patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2) who had an inadequate response to or failed to tolerate conventional therapies, or were corticosteroid dependent.
V indukcijski študiji (PURSUIT-Induction) so ocenili bolnike z zmerno do zelo aktivnim ulceroznim kolitisom (ocena Mayo od 6 do 12; endoskopska delna ocena ≥ 2), ki so se nezadostno odzvali na konvencionalne načine zdravljenja, jih niso prenašali ali so bili odvisni od kortikosteroidov.
The potential role of TNF-blocking therapy in the development of malignancies is not known.
Morebitna vloga zdravljenja z zaviralci TNF pri nastanku malignih bolezni ni znana.
In GO-BEFORE the change from baseline in the vdH-S score, a composite score of structural damage that radiographically measures the number and size of joint erosions and the degree of joint space narrowing in hands/wrists and feet, was used to assess the degree of structural damage.
V študiji GO-BEFORE so uporabili spremembo od začetne vrednosti rezultata vdH-S, ki je sestavljeni rezultat za strukturne okvare in na podlagi katerega radiografsko merimo število in velikost erozij v sklepih ter stopnjo zoženja sklepne špranje v rokah/zapestjih in stopalih za oceno stopnje strukturnih okvar.
• You can also use the lower stomach (abdomen) below the belly button, except for approximately the 5 cm area directly underneath the belly button.
• Za injiciranje lahko uporabite tudi spodnji del trebuha (abdomna) pod popkom, razen približno 5 cm širokega dela tik pod popkom.
• Asthma, shortness of breath, wheezing
• astma, kratka sapa, piskanje v pljučih,
Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Simponi.
Zdravniku morate povedati, če sočasno z zdravilom Simponi jemljete azatioprin ali 6-merkaptopurin.
Other information
DRUGI PODATKI
The diagram below (see figure 1) shows what the “SmartJect” pre-filled pen looks like.
Spodnji diagram (glejte sliko 1) prikazuje, kako izgleda napolnjeni injekcijski peresnik “SmartJect”.
Caution should be exercised when considering the use of golimumab in patients with a chronic infection or a history of recurrent infection.
Pri odločanju glede uporabe golimumaba pri bolnikih s kronično okužbo ali ponavljajočimi se okužbami v anamnezi je potrebna previdnost.
If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor right away.
Ob pojavu zvišane telesne temperature, ki ne mine, hitrim nastankom podplutb ali krvavitev ali zelo bledega videza, nemudoma pokličite zdravnika.
• A statement that the brand name and batch number should be recorded.
• Navedbo glede potrebnega beleženja imena ter številke serije zdravila.
• Check the expiration date printed or written on the carton.
• Preverite rok uporabnosti, ki je natisnjen ali napisan na škatli.
Analyses were performed on both the All Treated (AT, N = 197) and Objective Signs of Inflammation (OSI, N = 158, defined by elevated CRP and/or evidence of sacroiliitis on MRI at baseline) populations.
Analize so bile narejene za obe populaciji: populacijo vseh zdravljenih (All Treated - AT, N = 197) in populacijo z objektivnimi znaki vnetja (Objective Signs of Inflammation - OSI, N = 158, opredeljeni z zvišanjem CRP in/ali dokazi sakroiliitisa na MRI v izhodišču).
Following a single subcutaneous injection of 100 mg, the absorption of golimumab was similar in the upper arm, abdomen, and thigh, with a mean absolute bioavailability of 51%.
Po enkratni subkutani injekciji 100 mg zdravila je bila absorpcija golimumaba podobna ne glede na to, ali je bilo zdravilo injicirano v nadlaht, trebuh ali stegno, srednja vrednost absolutne biološke uporabnosti pa je bila 51 %.
Through approximately 4 years of follow-up, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar to the general population.
V približno 4 letih spremljanja je bila incidenca nelimfomskih malignih bolezni (z izjemo nemelanomskega kožnega raka) podobna kot v splošni populaciji.
• Please make sure you also have a list of all other medicines that you are using with you at any visit to a health care professional.
• Prosimo, da ob vsakem obisku pri zdravniku s seboj prinesete tudi seznam vseh drugih zdravil, ki jih jemljete.
If you do not respond well enough to these medicines, you will be given Simponi to treat your disease.
Če se na ta zdravila ne boste dovolj dobro odzvali, boste dobili za zdravljenje vaše bolezni zdravilo Simponi.
• swelling of small blood vessels (vasculitis) (rare).
• otekanje malih krvnih žil (vaskulitis) (redko).
Psoriatic arthritis (PsA)
Psoriatični artritis (PsA)
Simponi treatment resulted in significant improvement in physical function as assessed by HAQ DI, as well as significant improvements in health-related quality of life as measured by the physical and mental component summary scores of the SF-36.
Zdravljenje z zdravilom Simponi je vodilo do bistvenega izboljšanja telesne funkcije, ki so jo ocenili z vprašalnikom HAQ DI, pa tudi do bistvenega izboljšanja z zdravjem povezane kakovosti življenja, ki so jo izmerili z rezultati za telesno in duševno komponento vprašalnika SF-36.
Simponi should be given concomitantly with MTX.
Zdravilo Simponi uporabljamo skupaj z MTX.
Check security seal
Preverite varnostni pečat
It is used in children 2 years of age and older for the treatment of polyarticular juvenile idiopathic arthritis.
Uporablja se pri otrocih, starih 2 leti ali več, za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa.
The needle cover contains latex rubber.
Ščitnik igle vsebuje lateksno gumo.
The needle cover should not be removed until you are ready to inject the medicine.
Pokrovčka igle ne smete sneti, dokler niste pripravljeni za injiciranje zdravila.
• Bronchitis
• bronhitis,
It may harm them,
mravljinčenjem in draženjem),
What is in this leaflet What Simponi is and what it is used for What you need to know before you use Simponi How to use Simponi Possible side effects How to store Simponi Contents of the pack and other information
Kaj je zdravilo Simponi in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Simponi Kako uporabljati zdravilo Simponi Možni neželeni učinki
Serious infections observed in golimumab-treated patients included tuberculosis, bacterial infections including sepsis and pneumonia, invasive fungal infections and other opportunistic infections.
Resne okužbe, ki so jih opazili pri bolnikih, zdravljenih z golimumabom, so vključevale tuberkulozo, bakterijske okužbe, vključno s sepso in pljučnico, invazivne glivne in ostale oportunistične okužbe.
Press button to inject (see figure 7)
Pritisnite na gumb za injiciranje (glejte sliko 7)
This Patient Reminder Card contains important safety information that you need to be aware of before and during treatment with Simponi.
Ta opozorilna kartica vsebuje pomembne podatke o varnosti, ki jih morate upoštevati pred in med zdravljenjem z zdravilom Simponi.
Patients should be closely monitored and golimumab must be discontinued in patients who develop new or worsening symptoms of heart failure (see section 4.3).
Bolnike je treba skrbno spremljati in pri tistih, ki se jim na novo pojavijo znaki srčnega popuščanja oziroma se ti poslabšajo, golimumab ukiniti (glejte poglavje 4.3).
Remove the needle cover (see figure 5)
Snemite pokrovček igle (slika 5)
• You can also use the stomach (abdomen) below the belly button, except for approximately the 5 cm area directly underneath the belly button.
• Za injiciranje lahko uporabite tudi predel trebuha (abdomna) pod popkom, razen približno 5 cm širokega dela tik pod popkom.
No cases were reported in the controlled and uncontrolled periods of the nr-Axial SpA study (up to 1 year).
V kontroliranih in nekontroliranih obdobjih študije (do 1 leta) pri bolnikih z nr-aksialnim SpA niso poročali o nobenih primerih.
Common: Bone fractures
Pogosti: zlomi kosti
There may be a small amount of blood or liquid at the injection site.
Na mestu injiciranja bo morda majhna količina krvi ali tekočine.
Tell your doctor straight away if you get new or worsening symptoms of heart failure.
Nemudoma obvestite zdravnika, če se vam pojavijo ali poslabšajo simptomi srčnega popuščanja.
Concomitant stable doses of oral aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted.
Dovoljeni so bili sočasni ustaljeni odmerki peroralnih aminosalicilatov, kortikosteroidov in/ali imunomodulatorjev.
Statistically significant responses in DAS28 were also observed at weeks 14 and 24 (p < 0.05).
Statistično značilen odziv na zdravljenje, merjen z DAS28, so opazili tudi v 14. in 24. tednu (p < 0,05).
The pre-filled pen is now ready to use.
Napolnjen injekcijski peresnik je zdaj pripravljen za uporabo.
Use of TNF-blocking agents, including golimumab, has been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis and peripheral demyelinating disorders.
Uporaba zaviralcev TNF, vključno z golimumabom, je bila povezana s primeri novonastalih kliničnih simptomov in/ali rentgenskih znakov demielinizirajočih bolezni osrednjega živčevja, vključno z multiplo sklerozo ali s poslabšanjem teh znakov in simptomov in perifernimi motnjami demielinizacije.
Push and hold the pre-filled pen tip against the skin so the orange needle guard pushes up until it stops.
Konico napolnjenega injekcijskega peresnika pritisnite na kožo in jo držite, da oranžen ščitnik igle zdrsne navzgor, dokler se ne ustavi.
Concomitant stable doses of oral aminosalicylates, and/or immunomodulatory agents were permitted.
Dovoljeni so bili sočasni ustaljeni odmerki peroralnih aminosalicilatov in/ali imunomodulatorjev.
The binding of human TNF by golimumab was shown to neutralise TNF-α-induced cell-surface expression of the adhesion molecules E-selectin, vascular cell adhesion molecule (VCAM)-1 and intercellular adhesion molecule (ICAM)-1 by human endothelial cells.
Vezava humanega TNF na golimumab nevtralizira ekspresijo adhezijskih molekul E-selektina, žilne celične adhezijske molekule (VCAM)-1 in medcelične adhezijske molekule (ICAM)-1 na celični površini človeških endotelijskih celic, ki jo sproži TNF-α.
Ankylosing spondylitis
Ankilozirajoči spondilitis
• Chronic inflammatory condition of the lungs
• kronično vnetje pljuč,
• blood cancer (leukaemia) (rare).
• rak krvi (levkemija) (redko).
• When you are ready to inject, twist the cap slightly to break the security seal.
• Ko ste pripravljeni za injiciranje zdravila, malo obrnite pokrovček, da bo počil varnostni pečat.
Invasive fungal infections
Invazivne glivne okužbe
• Some of these reactions occurred after the first administration of Simponi.
• Nekatere od teh reakcij so se pojavile po prvi uporabi zdravila Simponi.
The needle cover on the pre-filled pen is manufactured from dry natural rubber containing latex, and may cause allergic reactions in individuals sensitive to latex.
Ščitnik igle na napolnjenem injekcijskem peresniku je izdelan iz suhe naravne gume, ki vsebuje lateks, in lahko povzroča alergijske reakcije pri posameznikih, ki so občutljivi za lateks.
Non-radiographic axial spondyloarthritis (nr-Axial SpA) Simponi is indicated for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
Neradiografski aksialni spondiloartritis (nr-aksialni SpA) Zdravilo Simponi je indicirano za zdravljenje odraslih s hudim aktivnim neradiografskim aksialnim spondiloartritisom z objektivnimi znaki vnetja, na katera kažeta zvišana vrednost C-reaktivnega proteina (CRP) in/ali magnetnoresonančno slikanje (MRI), ki se na nesteroidna protivnetna zdravila (NSAID) niso ustrezno odzvali ali jih ne prenašajo.
*CHOKING HAZARD!
*NEVARNOST ZADUŠITVE!
Tell your doctor straight away if you already have or get any symptoms of infection, during or after your treatment with Simponi.
Nemudoma obvestite zdravnika, če že imate simptome okužbe oziroma se vam ti pojavijo med ali po zdravljenju z zdravilom Simponi.
Simponi works by blocking the action of a protein called ‘tumour necrosis factor alpha' (TNF-α).
Zdravilo Simponi deluje tako, da zavira delovanje beljakovine, imenovane tumorje nekrotizirajoči faktor alfa (TNF-α).
For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of golimumab treatment should be carefully considered before initiation of golimumab therapy.
Pri bolnikih, ki so bivali v krajih ali potovali v kraje, kjer so invazivne glivne okužbe, kot so histoplazmoza, kokcidioidomikoza ali blastomikoza, endemske, je treba pred uvedbo zdravljenja z golimumabom skrbno pretehtati koristi in tveganja zdravljenja s tem zdravilom.
Polyarticular juvenile idiopathic arthritis in children 2 years of age and older:
Poliartikularni juvenilni idiopatski artritis pri otrocih, starih 2 leti ali več:
Sixty-eight percent (21/31) of antibody-positive patients had neutralising antibodies in vitro.
Oseminšestdeset odstotkov (21/31) bolnikov s pozitivnim izvidom na protitelesa je imelo nevtralizirajoča protitelesa in vitro.
In at-risk patients treated with golimumab, an invasive fungal infection should be suspected if they develop a serious systemic illness.
Pri bolnikih s tveganjem, ki so zdravljeni z golimumabom, je treba v primeru pojava resne sistemske bolezni posumiti na invazivno glivno okužbo.
Patients should be instructed to inject the prescribed amount of Simponi according to the comprehensive instructions for use provided in the pack.
Bolnikom je treba naročiti, naj si injicirajo predpisano količino zdravila Simponi v skladu z obsežnimi navodili za uporabo, ki so priložena v pakiranju.
Golimumab should be used with caution in patients with mild heart failure (NYHA class I/II).
Golimumab je treba pri bolnikih z blagim srčnim popuščanjem (razreda I ali II po klasifikaciji NYHA) previdno uporabljati.
Before you start using Simponi:
Preden začnete uporabljati zdravilo Simponi: