natgillin/translations-raw huggingface dataset:
Rare side effects (may affect up to 1 in 1,000 people): - loss of vision which may be caused by damage to the retina (such as obstruction of the blood vessels in the eye) or the optic nerve
- gubitak vida koji može biti uzrokovan oštećenjem mrežnice (poput začepljenja krvnih žila oka)
It should not be injected into an area of the body where the skin is irritated, reddened, bruised, infected or scarred.
Ne smije se injicirati u područje u kojem je koža iritirana, crvena, s modricama,
Besremi 250 mcg/0.5 mL injection ropeginterferon alfa-2b SC
Besremi 250 μg/0,5 ml injekcija ropeginterferon alfa-2b s.c.
Patients with 24 months of ropeginterferon alfa-2b treatment1
Bolesnici s 24-mjesečnim liječenjem ropeginterferenomom alfa-2b1
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen 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.
Besremi 250 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica od 0,5 ml otopine sadrži 250 mikrograma ropeginterferona alfa-2b mjereno na bazi proteina što odgovara 500 mikrograma/ml.
CTCAE intensity grade ≥3 N (%)
CTCAE stupanj intenziteta
• Raise a fold of skin between the thumb and forefinger.
• Palcom i kažiprstom uhvatite kožu u nabor.
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen 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.
Besremi 500 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica od 0,5 ml otopine sadrži 500 mikrograma ropeginterferona alfa-2b mjereno na bazi proteina što odgovara 1000 mikrograma/ml.
PT
Dob
Gastrointestinal disorders common diarrhoea, nausea, abdominal pain, constipation, abdominal distension, dry mouth uncommon gastritis, abdominal wall disorder, flatulence, frequent bowel movements, odynophagia, gingival bleeding not known tooth disorder#, periodontal disease#
Poremećaji probavnog sustava često proljev, mučnina, bol u trbuhu, konstipacija, abdominalna distenzija, suhoća usta manje često gastritis, poremećaj abdominalne stijenke, flatulencija,
Very rare side effects (may affect up to 1 in 10,000 people): - idiopathic or thrombotic thrombocytopenic purpura (increased bruising, bleeding, decreased platelets, anaemia and extreme weakness) - myocardial ischemia (reduced blood flow to your heart muscle)
smanjen broj trombocita, anemija i ekstremna slabost) - ishemija miokarda (smanjen dotok krvi u srčani mišić)
The absolute bioavailability of subcutaneous administered ropeginterferon alfa-2b was not investigated in humans.
Apsolutna bioraspoloživost supkutano primijenjenog ropeginterferon alfa-2b nije ispitivana u ljudi pa se stoga nije mogla provesti valjana procjena apsolutne bioraspoloživosti.
Uncommon side effects (may affect up to 1 in 100 people): - infection and re-infection with herpes, bacterial infections - increase in the number of platelets - autoimmune disorder of the thyroid gland, sarcoidosis (areas of inflamed tissue in different parts of the body) - diabetes - panic attack, hallucination (seeing, hearing or feeling things that are not there), feeling stressed, feeling nervous, lack of interest in activities, nightmare, irritability, confusion - damage to the nervous system, migraine, mental disorder (health condition involving changes in thinking, emotion or behaviour), visual or sensory disturbances, shaky hands - eye discomfort, eyelid eczema - hearing loss, ringing in ears (tinnitus), spinning feeling (vertigo) - heart disorders such as heart block (a disorder in the heart´s electrical activity), blood clots in the blood vessels of the heart, leakage of the aortic valve - high blood pressure, reduced blood supply to certain parts of the body, haematoma (collection of blood under the skin), flushing - inflammation of lung tissue, coughing, nosebleed, sore throat - inflammation of the stomach, abdominal wall disorder, intestinal gas, indigestion, painful swallowing, bleeding gums - inflammation of the liver, damage to the liver, enlarged liver - sensitivity to sunlight, peeling of the skin, nail disorder - muscle weakness, neck pain, groin pain - inflammation of the bladder, painful urination, increased need to urinate, inability to urinate - sexual problems - pain or itching at the site of injection, sensitivity to weather change - loss of weight - in blood tests: increase of uric acid, antibodies produced by the body´s immune system against red blood cells
- upala jetre, oštećenje jetre, uvećana jetra - osjetljivost na sunčevu svjetlost, ljuštenje kože, poremećaj noktiju - mišićna slabost, bol u vratu, bol u preponama - upala mokraćnog mjehura, bolno mokrenje, pojačana potreba za mokrenjem, nemogućnost mokrenja - problemi spolnog sustava - bol ili svrbež na mjestu primjene injekcije, osjetljivost na promjenu vremena - gubitak tjelesne težine
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b
Besremi 500 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici ropeginterferon alfa-2b
Ropeginterferon alfa-2b treatment arm
Ropeginterferon alfa
Each cartridge contains 0.5 mL of solution.
Jedan uložak sadrži 0,5 ml otopine.
Interaction studies of other pegylated interferon alfa medicinal products Co-administration of pegylated interferon alfa-2a with telbivudine in patients with hepatitis B increased the risk of developing peripheral neuropathy.
Ispitivanja interakcija drugih pegiliranih interferona alfa Istodobna primjena pegiliranog ropeginterferona alfa-2a s telbivudinom u bolesnika s hepatitisom B
Most common adverse reactions during ropeginterferon alfa-2b treatment.
Najčešće nuspojave tijekom liječenja ropeginterferonom alfa-2b Klinička ispitivanja s ropeginterferonom alfa-2b
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b
Besremi 250 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici ropeginterferon alfa-2b
- diarrhoea, nausea, abdominal pain or stomach discomfort, constipation, dry mouth - liver disorder, increase in certain liver enzymes (shown in blood tests) - itching, hair loss, rash, redness of skin, psoriasis, dry and scaly skin, acne, thickening of the outer layer of the skin, increased sweating - a disorder called Sjogren's syndrome where the body's immune system attacks glands that produce fluid (such as the tear and saliva glands), arthritis, pain in arms and legs, bone pain, painful sudden tightening of a muscle - fever, weakness, chills, general health problems, irritation or redness at the site of injection - in blood tests: antibodies which are produced by the body´s immune system, increase of an enzyme called lactate dehydrogenase
- proljev, mučnina, bol u trbuhu ili nelagoda, zatvor, suha usta - poremećaj jetre, porast određenih jetrenih enzima (što se vidi u krvnim pretragama) - svrbež, gubitak kose, osip, crvenilo kože, psorijaza, suha i ljušteća koža, akne, zadebljanje vanjskog sloja kože, pojačano znojenje
Complete haematological responsea Complete haematological responsea and improvement in disease burdenb
Potpuni hematološki odgovora Potpuni hematološki odgovora i poboljšanje u opterećenju bolešćub 52,6 (50/95)
Once a droplet of liquid appears at the needle tip, the pre-filled pen and the needle are working properly.
napunjena brizgalica i igla rade ispravno.
The dose will be set individually for you by your doctor for your condition.
Vaš liječnik će na temelju procjene Vaše bolesti odrediti dozu koja je prikladna baš.
No dose adjustment for ropeginterferon alfa-2b is required for adult patients with mild (GFR 6089 mL/min) or moderate (GFR 30-59 mL/min) renal impairment.
89 ml/min) ili umjerenim oštećenjem (GFR 30-59 ml/min) bubrega.
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.
Jedna napunjena brizgalica od 0,5 ml otopine sadrži 500 mikrograma ropeginterferona alfa-2b izmjerenog na bazi proteina što odgovara 1000 mikrograma/ml.
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.
Jedna napunjena brizgalica od 0,5 ml otopine sadrži 250 mikrograma ropeginterferona alfa-2b izmjerenog na bazi proteina što odgovara 500 mikrograma/ml.
Package leaflet: Information for the user Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b This medicine is subject to additional monitoring.
Uputa o lijeku: Informacije za korisnika Besremi 500 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici ropeginterferon alfa-2b
Package leaflet: Information for the user Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b This medicine is subject to additional monitoring.
Uputa o lijeku: Informacije za korisnika Besremi 250 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici ropeginterferon alfa-2b
JAK2V617F allele burden (%)* 41.9±23.49
Trajanje PV-a (mjeseci)* Opterećenje alelom JAK2V617F
Therefore, care should be taken when ropeginterferon alfa-2b is co-administered with CYP1A2 substrates notably those having a narrow therapeutic margin such as theophylline or methadone.
Stoga je potreban oprez kada se ropeginterferon alfa-2b uzima istodobno sa supstratima CYP1A2,
Coombs test positive, weight decreased #Reported as adverse reactions during treatment with other interferon alfa medicinal products.
#Prijavljeno kao nuspojave tijekom liječenja drugim lijekovima koji sadrže interferon alfa.
Vascular disorders common microangiopathy uncommon
Krvožilni poremećaji često mikroangiopatija manje često
• Discard the pen after use as instructed by your doctor or pharmacist.
• Nakon uporabe brizgalicu bacite u skladu s uputama
Dental and periodontal disorders
Poremećaji zubi i parodonta
Acute hypersensitivity
Potpuni hematološki odgovora
Content (concentration)
Sastav (koncentraci ja)
It is used to treat the following diseases:
Primjenjuje se za liječenje sljedećih bolesti:
This overview was last updated in 02-2019.
Ovaj pregled informacija posljednji je put ažuriran u 2. 2019.
Further information on Simponi can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/simponi.
Više informacija o lijeku Simponi nalazi se na internetskim stranicama Agencije: ema.europa.eu/en/medicines/human/EPAR/simponi.
Simponi received a marketing authorisation valid throughout the EU on 1 October 2009.
Simponi je dobio odobrenje za stavljanje u promet koje je na snazi u EU-u od 1. listopada 2009.
This was assessed after 6 weeks in the first study and after 54 weeks in the second study.
Procjena je provedena nakon šest tjedana u prvom ispitivanju te nakon 54 tjedna u drugom ispitivanju.
The main measure of effectiveness was the number of patients who responded to treatment, based on the number and severity of symptoms.
Glavno mjerilo učinkovitosti bio je broj bolesnika koji je reagirao na terapiju, na temelju broja i ozbiljnosti simptoma.
By blocking TNF-α, golimumab reduces the inflammation and other symptoms of these diseases.
Blokadom TNF golimumab smanjuje upalu i druge simptome tih bolesti.
What measures are being taken to ensure the safe and effective use of Simponi?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Simponi?
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.
Ispitivanje je također pokazalo da je u bolesnika koji su primili lijek Simponi došlo do većih poboljšanja pri izvođenju svakodnevnih aktivnosti (poput oblačenja, jedenja i hodanja) nakon 24 tjedna.
Other information about Simponi
Ostale informacije o lijeku Simponi
What is Simponi and what is it used for?
Što je Simponi i za što se primjenjuje?
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).
Najozbiljnije nuspojave uključuju ozbiljne infekcije kao što su sepsa (otrovanje krvi), pneumonija (upalu pluća), tuberkuloza i infekcije uzrokovane raznim vrstama gljivica, demijelinizirajući poremećaji (poremećaji koji upućuju na oštećenje zaštitne ovojnice oko živaca, kao što su poremećaji vida te slabost u rukama ili nogama), ponovno aktiviranje hepatitisa B (bolesti jetre koju uzrokuje virus hepatitisa B), kongestivno zatajenje srca (srčana bolest), sindrom sličan lupusu, krvne reakcije, ozbiljne alergijske reakcije, vaskulitis (upala krvnih žila) te limfom i leukemija (vrste raka bijelih krvnih stanica).
Simponi is an anti-inflammatory medicine.
Simponi je protuupalni lijek.
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.
Zbog povećanja rizika od infekcije, bolesnike koji uzimaju Simponi potrebno je pažljivo nadzirati za slučaj pojave infekcija, uključujući tuberkulozu, tijekom terapije i do pet mjeseci nakon terapije.
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).
Simponi se ne smije primjenjivati u bolesnika s tuberkulozom, drugim teškim infekcijama i umjerenim ili teškim zatajenjem srca (nemogućnost srca da pumpa dovoljne količine krvi u tijelu).
Simponi is used in combination with methotrexate (a medicine that acts on the immune system).
Simponi se primjenjuje u kombinaciji s metotreksatom (lijekom koji djeluje na imunosni sustav).
The most common side effects with Simponi are upper respiratory tract infections such as infections of the nose, throat or voice box.
Najčešće nuspojave lijeka Simponi su infekcije gornjih dišnih putova poput infekcija nosa, grla ili glasnica.
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;
Može se primjenjivati u odraslih bolesnika koji nisu adekvatno reagirali na druge terapije, uključujući i terapiju metotreksatom, čija je bolest umjerena do ozbiljna, te u bolesnika koji prethodno nisu bili liječeni metotreksatom, a čija je bolest ozbiljna i progresivna;
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.
Europska agencija za lijekove zaključila je da koristi od lijeka Simponi nadmašuju s njim povezane rizike te da može biti odobren za primjenu u Europskoj uniji.
What are the risks associated with Simponi?
Koji su rizici povezani s lijekom Simponi?
Treatment with Simponi and methotrexate was not compared with placebo or any other treatment.
Terapija lijekom Simponi i metotreksatom nije uspoređena s placebom ili bilo kojom drugom terapijom.
Golimumab has been designed to attach to and block a substance in the body called tumour necrosis factor alpha (TNF-α).
Golimumab je osmišljen kako bi vezivanjem na nju blokirao tvar u organizmu naziva faktor nekroze tumora alfa (TNF-α-).
Why is Simponi authorised in the EU?
Zašto je lijek Simponi odobren u EU-u?
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.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Simponi također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
As for all medicines, data on the use of Simponi is continuously monitored.
Kao i za sve lijekove, podatci o primjeni lijeka Simponi kontinuirano se prate.
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 protutijelo je protutijelo (vrsta bjelančevine) namijenjeno prepoznavanju određene strukture (nazvane antigen) u organizmu i vezivanju na nju.
An overview of Simponi and why it is authorised in the EU
Pregled informacija o lijeku Simponi i zašto je odobren u EU-u
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.
Lijek Simponi pokazao se djelotvornim u smanjenju broja i težine simptoma u bolesnika s bolestima za čije je liječenje odobren.
Simponi is available as pre-filled pens and syringes containing a solution for injection under the skin.
Simponi je dostupan u obliku napunjenih brizgalica i štrcaljki koje sadrže otopinu za injektiranje pod kožu.
Side effects reported with Simponi are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Simponi pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Simponi is used in combination with methotrexate.
Simponi se primjenjuje u kombinaciji s metotreksatom.
Patients should show this card when seeing a healthcare professional, so that they are aware that the patient is using Simponi.
Bolesnici bi tu karticu trebali pokazati kod svakog liječničkog pregleda, kako bi liječnik znao da bolesnik uzima lijek Simponi.
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.
Podatci iz rendgenskih snimaka napravljenih prije i nakon dvije godine terapije pokazali su manje oštećenje zglobova u bolesnika koji su primali lijek Simponi u odnosu na one koji su primali placebo.
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.
Kod poliartikularnog juvenilnog idiopatskog artritisa, 173 bolesnika u dobi od 2 i 18 godina, koji nisu adekvatno odgovorili na terapiju metotreksatom primilo je terapiju lijekom Simponi i metotreksatom.
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.
Lijek Simponi izdaje se samo na liječnički recept, a liječenje treba započeti i nadzirati liječnik s iskustvom u dijagnosticiranju i liječenju bolesti koje se liječe lijekom Simponi.
• polyarticular juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints).
• poliartikularnog juvenilnog idiopatskog artritisa (rijetke dječje bolesti koja uzrokuje upalu velikog broja zglobova).
The active substance in Simponi, golimumab, is a monoclonal antibody.
Djelatna tvar lijeka Simponi, golimumab, monoklonsko je protutijelo.
How does Simponi work?
Kako djeluje Simponi?
The recommended dose depends on the disease Simponi is used to treat and the response of the patient.
Preporučena doza lijeka Simponi ovisi o bolesti koju treba liječiti i reakciji bolesnika na terapiju.
What benefits of Simponi have been shown in studies?
Koje su koristi od lijeka Simponi utvrđene u ispitivanjima?
Simponi is used in adults who have not responded adequately to other treatments.
Simponi se primjenjuje u odraslih koji nisu adekvatno reagirali na druge terapije.
It is used in children from 2 years of age who have not responded adequately to treatment with methotrexate.
Primjenjuje se u djece od dvije godine i starijih koja nisu adekvatno reagirala na terapiju metotreksatom.
Of these patients, 87% of (151 out of 173) had 30% reduction in the number and severity of symptoms after 16 weeks.
Od tih je bolesnika u njih 87 % (151 od 173) došlo do 30 %-tnog smanjenja broja i težine simptoma nakon 16 tjedana.
For more information about using Simponi, see the package leaflet or contact your doctor or pharmacist.
Više informacija o primjeni lijeka Simponi pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
• active and progressive psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
• aktivnog i progresivnog psorijatičnog artritisa (bolesti koja uzrokuje crvene ljuskave lezije na koži i upalu zglobova).
The first study, involving 1,065 patients, compared different doses of Simponi with placebo as induction treatment.
U prvom ispitivanju na 1 065 bolesnika uspoređivane su različite doze lijeka Simponi s placebom kao indukcijskom terapijom.
Patients treated with Simponi must be given a reminder card that summarises the safety information about the medicine and when to seek medical advice.
Bolesnici na terapiji lijekom Simponi moraju dobiti posebnu karticu u kojoj su sažete informacije o sigurnoj primjeni lijeka te u kojim slučajevima treba potražiti liječničku pomoć.
It can be used alone or in combination with methotrexate;
Može se primjenjivati kao monoterapija ili u kombinaciji s metotreksatom.
Simponi is used in adults who have not responded adequately to, or cannot use, conventional treatment;
Simponi se primjenjuje u odraslih koji nisu adekvatno reagirali na konvencionalnu terapiju ili je ne mogu primiti.
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 je tvar uključena u nastanak upale te se u visokim razinama nalazi u bolesnika oboljelih od bolesti koje se liječe lijekom Simponi.
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.
U trećem ispitivanju u bolesnika koji prethodno nisu bili liječeni ni metotreksatom ni drugim anti-TNF-, nakon 24 tjedna u 40 % bolesnika (64 od 159) koji su primili lijek Simponi s metotreksatom došlo je do 50 %-tnog smanjenja, u usporedbi s 29 % bolesnika (47 od 160) koji su primili placebo i metotreksat.
The second study, involving 1,228 patients, compared Simponi 50 or 100 mg with placebo as maintenance treatment.
U drugom ispitivanju na 1 228 bolesnika, uspoređivane su doze lijeka Simponi od 50 ili 100 mg s placebom kao terapijom održavanja.
After training, patients may inject themselves with Simponi if their doctor agrees.
Nakon obuke i uz suglasnost liječnika, bolesnici si sami mogu injektirati lijek Simponi.
• 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);
- odrasle bolesnike s ozbiljnim aksijalnim spondiloartritisom bez radiografskih dokaza (kada postoje objektivni znakovi upale, ali abnormalnosti nisu uočene na rendgenskoj snimci) koji nisu adekvatno reagirali na protuupalne lijekove naziva nesteroidni protuupalni lijekovi (NSAID-ovi) ili ih ne podnose;