natgillin/translations-raw huggingface dataset:
Do not use the 5-centimetre area around your belly-button.
Ne uporabite 5-centimetrskega predela okrog popka.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Zaradi boljše sledljivosti bioloških zdravil morata biti jasno zabeležena ime in serijska številka prejetega zdravila.
• allergic reactions which may be serious, or rarely, life-threatening (rare).
• alergijske reakcije, ki so lahko resne ali v redkih primerih življenjsko nevarne (redko).
In this case you will get training on how to inject Simponi.
V tem primeru boste deležni usposabljanja o tem, kako injicirati zdravilo Simponi.
Tell your doctor straight away if you notice any of the above symptoms.
Nemudoma obvestite zdravnika, če opazite katerega koli od zgoraj navedenih simptomov.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Znotraj vsake skupine pogostnosti so neželeni učinki razvrščeni po padajoči resnosti.
• Reduce the signs and symptoms of your disease.
• za ublažitev znakov in simptomov bolezni,
There are no adequate data on the use of golimumab in pregnant women.
Ni zadostnih podatkov o uporabi golimumaba pri nosečnicah.
N = number of patients ** p ≤ 0.001 * p ≤ 0.01
N = število bolnikov ** p ≤ 0,001 * p ≤ 0,01
The systemic clearance of golimumab was estimated to be 6.9  2.0 mL/day/kg.
Sistemski očistek golimumaba so ocenili na 6,9 ± 2,0 ml/dan/kg.
• Provision to record the type, date, and result of TB screenings.
• Prostor za beleženje vrste, datuma in rezultata presejalnih testov na TB.
If the yellow indicator is not shown in the window, the plunger has not advanced adequately, and the injection has not occurred.
Če rumeni kazalnik ni viden v okencu, se bat ni ustrezno sprožil in do injiciranja ni prišlo.
• You usually inject the medicine into the front of the middle thighs.
• Zdravilo si običajno injicirate v sprednji srednji del stegna.
Patients taking TNF-blockers are more susceptible to serious infections.
Bolniki, ki jemljejo zaviralce TNF, so bolj občutljivi za resne okužbe.
You must not be treated with Simponi if you have tuberculosis (TB) or any other severe infection.
Zdravila Simponi ne smete prejemati, če imate tuberkulozo (TB) ali katero koli drugo hudo okužbo.
Concurrent use with other biological therapeutics
Sočasna uporaba z drugimi biološkimi zdravili
At week 14, 28% of these patients achieved response defined by partial Mayo score (decreased by ≥ 3 points compared with start of induction).
V 14. tednu je 28 % teh bolnikov doseglo odziv, opredeljen z delno oceno Mayo (znižanje za ≥ 3 točke v primerjavi z začetkom indukcije).
Simponi must be discarded if not used within the 30 days of room temperature storage.
Zdravilo Simponi je treba zavreči, če se ga ne uporabi znotraj 30 dni shranjevanja na sobni temperaturi.
All patients had a history of heavy smoking.
Vsi ti bolniki so imeli v anamnezi strastno kajenje.
• You are pregnant or are planning to become pregnant while using Simponi.
• če ste noseči ali načrtujete nosečnost med uporabo zdravila Simponi.
Infections may progress more rapidly and may be more severe.
Okužbe lahko napredujejo hitreje in so lahko hujše.
Injecting without pinching the skin is recommended (Figure 5a).
Priporočeno je injiciranje brez stiskanja kože (slika 5a).
Studies in animals do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Študije pri živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na nosečnost, razvoj zarodka ali ploda, porod ali poporodni razvoj (glejte poglavje 5.3).
Active tuberculosis (TB) or other severe infections such as sepsis, and opportunistic infections (see section 4.4).
Aktivna tuberkuloza (TB) ali druge hude okužbe, kot je sepsa, ter oportunistične okužbe (glejte poglavje 4.4).
• Infections may progress more rapidly and may be more severe.
• Okužbe lahko napredujejo hitreje in so lahko hujše.
Neurological events
Nevrološki dogodki
In case of an overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment be instituted immediately.
V primeru prevelikega odmerjanja se priporoča, da se bolnika spremlja glede kakršnih koli znakov ali simptomov neželenih učinkov in se mu nemudoma uvede ustrezno simptomatično zdravljenje.
• Wash your hands thoroughly with soap and warm water.
• Temeljito si umijte roke z milom in toplo vodo.
After proper training in subcutaneous injection technique, patients may self-inject if their physician determines that this is appropriate, with medical follow-up as necessary.
Po ustreznem usposabljanju o tehniki subkutanega injiciranja, si lahko bolniki zdravilo injicirajo sami, če njihov zdravnik presodi, da je to primerno, po potrebi tudi pod zdravniškim nadzorom.
Because latex may cause severe allergic reactions, talk to your doctor before using Simponi if you or your carer are allergic to latex.
Ker lahko lateks povzroči hude alergijske reakcije, se pred uporabo zdravila Simponi posvetujte z zdravnikom, če ste vi ali vaš skrbnik alergični na lateks.
• While you are waiting you can get the rest of your equipment ready, including an alcohol swab,
• Med čakanjem si lahko pripravite vse ostale potrebščine, vključno z alkoholnim zložencem,
This protein is involved in inflammatory processes of the body, and blocking it can reduce the inflammation in your body.
Ta beljakovina sodeluje pri vnetnih procesih v telesu in lahko z njenim zaviranjem zmanjšamo vnetje v telesu.
The concomitant use of golimumab with these biologics is not recommended because of the possibility of an increased risk of infection, and other potential pharmacological interactions.
Sočasna uporaba golimumaba s temi biološkimi zdravili ni priporočljiva zaradi možnosti povečanega tveganja za okužbe in drugih potencialnih farmakoloških interakcij.
If this happens, do not drive or use any tools or machines.
Če se vam to zgodi, ne vozite ali uporabljajte orodij ali strojev.
At week 54, the clinical outcomes observed in these patients were similar to the clinical outcomes reported for the patients achieving clinical response at week 6.
V 54. tednu so bili klinični izidi, ki so jih opazili pri teh bolnikih, podobni kliničnim izidom, ki so jih poročali pri bolnikih, ki so dosegli klinični odziv v 6. tednu.
• Tell your doctor or pharmacist if you are taking any other medicines that affect your immune system.
• Obvestite zdravnika ali farmacevta, če jemljete katera koli druga zdravila, ki vplivajo na vaš imunski sistem.
ASAS Partial Remission ASDAS-C
ASAS delna remisija ASDAS-C
The orange priming band will disappear.
Oranžen pas bo izginil.
The radiographic effects observed at week 52 were maintained through week 104.
Tudi radiografski učinki, ki so jih ugotovili v 52. tednu, so se ohranili do 104. tedna.
Talk to your child's doctor regarding vaccinations for your child.
O cepljenjih vašega otroka se posvetujte z otrokovim zdravnikom.
It is not known if golimumab treatment influences the risk for developing dysplasia or colon cancer.
Ni znano, ali zdravljenje z golimumabom vpliva na tveganje za nastanek displazije ali raka kolona.
The results of the maintenance study (PURSUIT-Maintenance) were based on evaluation of 456 patients who achieved clinical response from previous induction with Simponi.
Rezultati vzdrževalne študije (PURSUIT-Maintenance) so temeljili na oceni 456 bolnikov, ki so med predhodno indukcijo z zdravilom Simponi dosegli klinični odziv.
An effect on serum golimumab concentrations was seen at titres of > 1:100 while an effect on efficacy was not seen until titres of > 1:1000, though the numbers of children with titres of > 1:1000 were low (N = 8).
Vpliv na serumske koncentracije golimumaba je bil viden pri titrih > 1:100, medtem ko vpliva na učinkovitost ni bilo opaziti do titrov > 1:1.000, čeprav je bilo število otrok s titri > 1:1.000 majhno (N = 8).
Patients should be instructed not to inject a double dose to make up for the forgotten dose.
Bolnikom je treba naročiti, naj si ne injicirajo dvojnega odmerka, da bi nadomestili pozabljeni odmerek.
Tell your doctor if you develop symptoms of a disease called lupus.
Obvestite zdravnika, če se vam pojavijo simptomi bolezni, imenovane lupus.
The role of golimumab as a contributing or aggravation factor cannot be excluded.
Vloge golimumaba kot dejavnika, ki dodatno prispeva k takemu stanju ali ga poslabša, pri tem dogodku ni mogoče izključiti.
Call your doctor, nurse or pharmacist to talk about any questions you may have.
Pokličite zdravnika, medicinsko sestro ali farmacevta, da se boste pogovorili o morebitnih vprašanjih.
Table 7 Key efficacy outcomes from PURSUIT - Induction and PURSUIT - Maintenance PURSUIT-Induction
Preglednica 7 Ključni izidi učinkovitosti iz študij PURSUIT - Induction in PURSUIT - Maintenance PURSUIT-Induction
Some patients may experience serious side effects and may require treatment.
Pri nekaterih bolnikih se lahko pojavijo resni neželeni učinki, ki lahko potrebujejo zdravljenje.
Remove air bubbles*
Odstranite zračne mehurčke*
Vaccinations Talk to your doctor if you have had, or are due to have a vaccine.
Cepljenja Posvetujte se z zdravnikom, če ste bili ali morate biti cepljeni.
• Once the button is pressed, it will remain pressed in so you do not need to keep pressure on it.
• Ko ste enkrat pritisnili na ta gumb, ga ne bo treba več pritiskati, ker bo ostal v takem položaju.
• Tell your doctor if you have an infection.
• Zdravniku povejte, če imate okužbo.
• Children weighing less than 40 kg: The recommended dose of Simponi for children weighing less than 40 kg depends on their weight and height.
• Otroci, ki tehtajo manj kot 40 kg: Priporočeni odmerek zdravila Simponi za otroke, ki tehtajo manj kot 40 kg, je odvisen od njihove telesne mase in višine.
In addition to the primary endpoint(s), additional assessments of the impact of Simponi treatment on the signs and symptoms of arthritis, radiographic response, physical function and health-related quality of life were performed.
Poleg določitve primarnega končnega rezultata(ov) so opravili tudi dodatne ocene vpliva zdravljenja z zdravilom Simponi na znake in simptome artritisa, radiografski odziv, telesno funkcijo in z zdravjem povezano kakovost življenja.
For more information on sorbitol (E420), see Section 2.
Za več informacij glede sorbitola (E420) glejte poglavje 2.
• Abnormal liver tests (increased liver enzymes) found during blood tests done by your doctor
• nenormalni izvidi jetrnih testov (zvišanje vrednosti jetrnih encimov), ugotovljeni s krvnimi preiskavami, ki jih opravi zdravnik,
Throughout this section, median duration of follow-up (approximately 4 years) is generally presented for all golimumab use.
V tem poglavju je mediano trajanje spremljanja bolnikov (približno 4 leta) na splošno predstavljeno za vse načine uporabe golimumaba.
The combination of golimumab and abatacept is not recommended.
Kombiniranje golimumaba in abatacepta ni priporočljivo.
Each pre-filled pen is for single use in a single patient, and should be discarded immediately after use.
Vsak napolnjen injekcijski peresnik je namenjen za enkratno uporabo pri enem samem bolniku in ga je treba zavreči takoj po uporabi.
• Your doctor should test you for HBV
• Zdravnik vas mora testirati za HBV.
Because the elimination of golimumab may take up to 5 months, monitoring should be continued throughout this period.
Ker lahko izločanje golimumaba iz telesa traja do 5 mesecev, je treba v tem času bolnika še naprej spremljati.
• You should not take Simponi with medicines containing the active substance anakinra or abatacept.
• Zdravila Simponi ne smete jemati hkrati z zdravili, ki vsebujejo učinkovini anakinra ali abatacept.
Approximately forty-eight percent of patients continued on stable doses of methotrexate (≤ 25 mg/week).
Približno 48 % bolnikov je še naprej jemalo stalne odmerke metotreksata (≤ 25 mg/teden).
Patients had at least 4 swollen and 4 tender joints.
Ti bolniki so imeli najmanj 4 otekle in 4 boleče sklepe.
ACR 70 Week 14 4% 14% p = 0.008
ACR 70 14. teden 4 % 14 % p = 0,008
• nervous system disease such as multiple sclerosis (rare).
• bolezni živčevja, kot je multipla skleroza (redko).
The higher incidence of antibodies with the drug-tolerant EIA method, because they were mainly low titre antibodies, did not have an apparent impact on drug levels, efficacy and safety and therefore does not represent any new safety signal.
Večja pojavnost protiteles pri metodi EIA, ki je tolerantna za zdravilo, zaradi večinoma nizkega titra protiteles ni imela opaznega vpliva na koncentracije zdravila, učinkovitost in varnost, zato ne predstavlja novega varnostnega signala.
If a small dose is set, the plunger will only move a short distance.
Če imate nastavljen majhen odmerek, se bo bat premaknil le malo.
Radiographic response:
Radiografski odziv
• The second ‘click' means that the injection is finished and the needle has gone back into the pre-filled pen.
• Drugi ‘klik' pomeni, da je injiciranje končano in se je igla vrnila nazaj v napolnjeni injekcijski peresnik.
In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding.
Pri nekaterih bolnikih telo morda ne tvori dovolj krvnih celic, ki se borijo proti okužbam ali ustavijo krvavitve.
Wipe your chosen injection site with an alcohol swab and allow it to dry.
Izbrano mesto injiciranja obrišite z alkoholnim zložencem in pustite, da se posuši.
Additional analyses were performed in subsets representative of the indicated population of patients with severe, active and progressive RA.
Izvedene so bile tudi dodatne analize pri podskupinah, ki so reprezentativne za navedeno populacijo bolnikov s hudim, aktivnim in napredujočim revmatoidnim artritisom.
Therefore, a patient who maintained response was in a state of continuous clinical response at each evaluation through week 54.
Zato je bolnik, ki je ohranil odziv, imel kontinuirano klinični odgovor ob vsakem ocenjevanju do 54. tedna.
Patients in this study had a diagnosis of PsA for at least 6 months and had at least mild psoriatic disease.
Bolniki v tej študiji so imeli diagnozo psoriatičnega artritisa najmanj 6 mesecev in so imeli najmanj blago psoriatično bolezen.
Golimumab should not be given to patients with a clinically important, active infection.
Golimumaba se ne sme dajati bolnikom s klinično pomembno aktivno okužbo.
Children and adolescents Simponi 100 mg is not recommended for children and adolescents (younger than 18 years).
Otroci in mladostniki Zdravilo Simponi 100 mg ni priporočljivo za otroke in mladostnike (mlajše od 18 let).
Moderate or severe heart failure (NYHA class III/IV) (see section 4.4).
Zmerno ali hudo srčno popuščanje (razredov III/IV po klasifikaciji NYHA) (glejte poglavje 4.4).
Push the pre-filled pen firmly against the skin (see figures 5 and 6) • Hold the pre-filled pen comfortably in your hand.
Napolnjeni injekcijski peresnik močno pritisnite na kožo (glejte sliki 5 in 6) • Napolnjeni injekcijski peresnik udobno držite v roki.
• Talk to your doctor if you are going to have any operations or dental procedures.
• Posvetujte se z zdravnikom, če boste imeli kakršno koli operacijo ali zobozdravstven poseg.
Do not use Simponi:
Ne uporabljajte zdravila Simponi:
This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Ta redka vrsta T-celičnega limfoma poteka zelo agresivno in se po navadi konča s smrtnim izidom.
• Front of thighs (recommended)
• sprednjo stran stegen (priporočeno)
Common: Depression, insomnia
Pogosti: depresija, nespečnost
• 1 Sharps container (See Step 3)
• 1 vsebnik za ostre odpadke (glejte 3. korak)
Key results are shown in Table 6 and described below.
Ključni rezultati so prikazani v preglednici 6 in opisani spodaj.
The printed expiration date refers to the last day of the month.
Natisnjeni datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Simponi contains latex and sorbitol
Zdravilo Simponi vsebuje lateks in sorbitol
The small number of patients positive for antibodies to golimumab limits the ability to draw definitive conclusions regarding the relationship between antibodies to golimumab and clinical efficacy or safety measures.
Majhno število bolnikov s pozitivnimi testi protiteles proti golimumabu omejuje možnost oblikovanja dokončnih zaključkov glede povezave med nastankom protiteles proti golimumabu in klinično učinkovitostjo zdravila ter varnostnimi ukrepi.
• If your doctor feels that you are at risk of TB, you may be treated with medicines for TB before you begin using Simponi.
• Če zdravnik presodi, da obstaja pri vas tveganje za TB, vas bo morda zdravil z zdravili proti TB preden začnete uporabljati zdravilo Simponi.
In case you have received Simponi while you were pregnant, it is important that you inform your baby's doctor about it before your baby receives any vaccine.
Če ste med nosečnostjo prejeli zdravilo Simponi, je pomembno, da o tem obvestite zdravnika vašega dojenčka, preden dojenček prejme katero koli cepivo.
What Simponi is and what it is used for
Kaj je zdravilo Simponi in za kaj ga uporabljamo
Similar rates were shown across rheumatologic indications.
Podobne pogostnosti so dobili za vse revmatološke indikacije.
Plan ahead
Načrtujte vnaprej
The baseline median number of active joints was 12, and median CRP was 0.17 mg/dL.
Izhodiščno mediano število aktivno prizadetih sklepov je bilo 12, mediana vrednost CRP pa 0,17 mg/dl.
The use of golimumab in pregnant women is not recommended; golimumab should be given to a pregnant woman only if clearly needed.
Uporaba golimumaba pri nosečih ženskah ni priporočljiva; nosečnici se ga sme predpisati le, če je nujno potrebno.
Do not put the cap back on, this may damage the hidden needle.
Pokrovčka ne nameščajte nazaj, saj lahko to poškoduje skrito iglo.
• 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 or has TB.
• Zelo pomembno je, da zdravniku poveste, če ste kdaj imeli TB oziroma če ste bili v tesnem stiku z osebo, ki je imela ali ima TB.
Golimumab was shown to pass over to breast milk in monkeys, and because human immunoglobulins are excreted in milk, women must not breast feed during and for at least 6 months after golimumab treatment.
Pokazalo se je, da golimumab pri opicah prehaja v materino mleko, in ker se tudi humani imunoglobulini izločajo v materino mleko, ženske med zdravljenjem z golimumabom in še najmanj 6 mesecev po njem ne smejo dojiti.
Marketing Authorisation Holder and Manufacturer Janssen Biologics B.V.
Imetnik dovoljenja za promet z zdravilom in izdelovalec Janssen Biologics B.V.
For administration instructions, see section 6.6.
Za navodila glede injiciranja glejte poglavje 6.6.
Health-related quality of life as measured by the physical component score of the SF-36 was also improved significantly at weeks 14 and 24.
Tudi z zdravjem povezana kakovost življenja, merjena s telesno komponento rezultata SF-36, se je bistveno izboljšala v 14. in 24. tednu.
• You should be screened for TB.
• Opraviti morate presejalne preiskave za TB.
Eight malignancies in the combined golimumab treatment group (n = 230) and none in the placebo treatment group (n = 79) were reported.
Poročali so o osmih malignomih v skupinah, zdravljenih z golimumabom (n = 230), in nobenem v skupini, ki je prejemala placebo (n = 79).
In patients with rare hereditary problems of fructose intolerance, the additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account (see section 2).
Pri bolnikih z redko dedno intoleranco za fruktozo je treba upoštevati aditivni učinek sočasno prejetih zdravil, ki vsebujejo sorbitol (ali fruktozo), ter zaužito količino sorbitola (ali fruktoze) (glejte poglavje 2).
If you have severe persistent asthma, COPD or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.
Če imate hudo trdovratno astmo, KOPB ali veliko kadite, se morate posvetovati z zdravnikom, ali je zdravljenje z zaviralcem TNF za vas primerno.
• signs of immune system disorders called: lupus (rare).
• znake bolezni imunskega sistema, imenovane: lupus (redko).
The orange needle guard will extend and lock.
Oranžen ščitnik igle se bo pomaknil in zaklenil.
Operations or dental procedures
Operacije ali zobozdravstveni posegi
• Keep this card with you for 6 months after the last Simponi dose, since side effects may occur a long time after your last dose of Simponi.
• To kartico nosite s seboj še 6 mesecev po zadnjem odmerku zdravila Simponi, ker se lahko neželeni učinki zdravila pojavijo še dolgo časa po prejemu zadnjega odmerka.
• Simponi is given by injection under the skin (subcutaneously).
• Zdravilo Simponi je treba injicirati pod kožo (subkutano).
• Some patients treated with golimumab have developed certain kinds of skin cancer.
• Pri nekaterih bolnikih, zdravljenih z golimumabom, so se pojavile določene vrste kožnega raka.
Injection site reactions generally did not necessitate discontinuation of the medicinal product.
Pojav reakcije na mestu injiciranja običajno ne zahteva ukinitve zdravljenja.
Some cases have had fatal outcome.
Nekateri primeri so se končali s smrtnim izidom.
In patients receiving anti-TNF therapy, limited data are available on the response to vaccination with live vaccines or on the secondary transmission of infection by live vaccines.
Pri bolnikih, ki prejemajo anti-TNF terapijo, je na voljo malo podatkov o odzivu na cepljenje z živimi cepivi ali o sekundarnem prenosu okužbe, povzročene z živimi cepivi.
Table 6 Key efficacy outcomes from GO-AHEAD at week 16 Improvements in signs and symptoms
Preglednica 6 Ključni izidi učinkovitosti v študiji GO-AHEAD v 16. tednu Izboljšanje znakov in simptomov
For information regarding the polyarticular juvenile idiopathic arthritis indication, please see the Simponi 50 mg SmPC.
Za informacije glede indikacije poliartikularni juvenilni idiopatski artritis, prosimo, glejte SmPC za zdravilo Simponi 50 mg.
Some of these serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections.
Nekatere od teh resnih okužb so se pojavile pri bolnikih na sočasni imunosupresivni terapiji, ki poleg osnovne bolezni prav tako lahko prispeva k povečani občutljivosti za okužbe.
No mutagenicity studies, animal fertility studies nor long-term carcinogenic studies have been conducted with golimumab.
Študije mutagenosti, študije plodnosti pri živalih in dolgoročne študije kancerogenosti z golimumabom niso bile opravljene.
Physical function and health-related quality of life Physical function and disability were assessed as a separate endpoint in GO-FORWARD and GO-AFTER using the disability index of the HAQ DI.
Telesna funkcija in z zdravjem povezana kakovost življenja Telesno funkcijo in stopnjo invalidnosti so v študijah GO-FORWARD in GO-AFTER ocenjevali kot ločena končna rezultata s pomočjo indeksa invalidnosti HAQ DI.
Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of conditions for which Simponi is indicated.
Zdravljenje morajo uvesti in nadzorovati usposobljeni zdravniki, ki imajo izkušnje s področja diagnostike in zdravljenja bolezni, za katere je zdravilo Simponi indicirano.
Your doctor will record these tests on your Patient Reminder Card.
Zdravnik bo te preiskave zabeležil na vašo opozorilno kartico za bolnika.
Lymphoma was reported in 1 patient, non-melanoma skin cancer in 2 patients, and other malignancies in 5 patients.
O limfomu so poročali pri 1 bolniku, o nemelanomskem kožnem raku pri 2 bolnikih in o drugih malignomih pri 5 bolnikih.
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin.
Psoriatični artritis je vnetna bolezen sklepov, ki jo običajno spremlja psoriaza, vnetna bolezen kože.