natgillin/translations-raw huggingface dataset:
2 vials of 0.6 ml 2 sterile 1 ml injection syringes with retractable injection needle 4 alcohol swabs
2 viali po 0, 6 ml 2 sterilni 1- mililitrski injekcijski brizgi z vskočno injekcijsko iglo 4 alkoholni zloženci
7 vials of 0.6 ml 7 sterile 1 ml injection syringes with retractable injection needle 14 alcohol swabs
7 vial po 0, 6 ml 7 sterilnih 1- mililitrskih injekcijskih brizg z vskočno injekcijsko iglo 14 alkoholnih zložencev
Wyeth Europa Limited Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 0PH United Kingdom Tel:
Wyeth Europa Limited Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 0PH Velika Britanija Tel:
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
17 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
0.6 ml of solution (12 mg methylnaltrexone bromide)
0, 6 ml raztopine (12 mg metilnaltreksonijevega bromida)
16 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
18 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
LABEL TEXT FOR TRAY LIDDING
BESEDILO NA NALEPKI PREKRIVNE FOLIJE LEŽIŠČA
18 PACKAGE LEAFLET:
20 NAVODILO ZA UPORABO:
RELISTOR 12 mg/ 0.6 ml solution for injection Methylnaltrexone bromide
RELISTOR 12 mg/ 0, 6 ml raztopina za injiciranje Metilnaltreksonijev bromid
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem
tell your doctor or pharmacist.
navodilu, obvestite svojega zdravnika ali farmacevta.
What RELISTOR is and what it is used for 2.
Kaj je zdravilo RELISTOR in za kaj ga uporabljamo 2.
Before you use RELISTOR 3.
Kaj morate vedeti, preden boste uporabili zdravilo RELISTOR 3.
How to use RELISTOR 4.
Kako uporabljati zdravilo RELISTOR 4.
How to store RELISTOR 6.
Shranjevanje zdravila RELISTOR 6.
WHAT RELISTOR IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO RELISTOR IN ZA KAJ GA UPORABLJAMO
RELISTOR treats constipation that is caused by medicines for moderate to severe pain called opioids (for example morphine, codeine).
Zdravilo RELISTOR se uporablja za zdravljenje zaprtja, ki ga povzročajo zdravila za lajšanje zmerne do hude bolečine, ki se imenujejo opioidi (na primer morfin in kodein).
RELISTOR is given on top of your usual laxatives.
Zdravilo RELISTOR boste jemali poleg svojih običajnih odvajal.
RELISTOR is for use in adults (aged 18 and over).
Zdravilo RELISTOR je namenjeno za uporabo pri odraslih (starih vsaj 18 let).
BEFORE YOU USE RELISTOR
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO RELISTOR
Do not use RELISTOR
Ne uporabljajte zdravila RELISTOR
- If you are allergic (hypersensitive) to methylnaltrexone bromide or any of the other ingredients.
- če ste alergični na (preobčutljivi za) metilnaltreksonijev bromid ali katerokoli od drugih sestavin,
- If you or your doctor know that your bowels are obstructed or your bowels are in a state where
- če vi sami veste ali če vaš zdravnik ve, da imate zaporo črevesa, ali če je vaše črevo v takšnem stanju, da je
there is an immediate need for surgical intervention (which has to be diagnosed by your doctor).
potreben takojšen kirurški poseg (diagnozo takega stanja pa mora postaviti vaš zdravnik).
Take special care with RELISTOR
Bodite posebno pozorni pri zdravilu RELISTOR
- If you have severe liver or kidney disease.
- če imate težko bolezen jeter ali ledvic.
- If you develop severe or persistent diarrhoea (passing of frequent watery stools) discontinue
- Če se pri vas razvije težka ali trdovratna driska (pogosto odvajanje vodenega blata), prenehajte jemati
therapy and contact your doctor immediately.
zdravilo RELISTOR in se takoj obrnite na svojega zdravnika.
- It is important to be near a toilet with assistance available if necessary, since bowel movement
- Pomembno je, da ste blizu stranišča in da je na voljo pomoč, če je to potrebno, ker lahko pride do
may happen within 30 minutes after injection of the medicine.
iztrebljanja že v 30 minutah po vbrizganju zdravila.
- Please talk to your doctor if you experience persistent stomach pain, nausea, (feeling sick in the
- Pogovorite se s svojim zdravnikom, če se pojavijo ali se vam poslabšajo trdovratne bolečine v trebuhu,
stomach) or vomiting that is new or worsened.
navzea (slabost s siljenjem na bruhanje) ali bruhanje.
- Please also talk to your doctor if you have a colostomy, a peritoneal catheter, or already known
- Pogovorite se s svojim zdravnikom tudi, če imate kolostomijo, peritonealni kateter ali če veste, da imate
disease called diverticular disease or faecal impaction.
divertikularno bolezen ali impaktacijo blata.
- If you have suffered from constipation before you had to take opioids (for pain), please also talk to
- Pogovorite se z zdravnikom tudi, če ste bili zaprti, še preden ste morali začeti jemati opioide (zaradi
your doctor.
bolečine).
19 Using other medicines
Jemanje drugih zdravil
Using RELISTOR with food and drink
Uporaba zdravila RELISTOR skupaj s hrano in pijačo
RELISTOR can be taken with or without food.
Zdravilo RELISTOR lahko uporabljate skupaj s hrano ali brez nje.
The effects of methylnaltrexone bromide in pregnant women are not known, and so the use of RELISTOR during pregnancy is not recommended.
Učinkov metilnaltreksonijevega bromida pri nosečnicah ne poznamo, zato uporaba zdravila RELISTOR med nosečnostjo ni priporočljiva.
Women using RELISTOR should not breast-feed, since it is not known if methylnaltrexone bromide passes into human breast milk.
Ženske, ki uporabljajo zdravilo RELISTOR, ne smejo dojiti, ker ni znano, ali metilnaltreksonijev bromid pri ljudeh prehaja v materino mleko.
RELISTOR may cause dizziness, and this may have an effect on driving and use of machines.
Zdravilo RELISTOR lahko povzroči vrtoglavost, kar lahko vpliva na upravljanje vozil in strojev.
Important information about some of the ingredients of RELISTOR
Pomembne informacije o nekaterih sestavinah zdravila RELISTOR
This medicine contains less than 1 mmol sodium (23 mg) per dose i. e., essentially “ sodium free .”
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘ brez natrija ’.
HOW TO USE RELISTOR
KAKO UPORABLJATI ZDRAVILO RELISTOR
Always use RELISTOR exactly as your doctor has told you.
Pri uporabi zdravila RELISTOR natančno upoštevajte zdravnikova navodila.
The usual dose is 8 mg methylnaltrexone bromide (0.4 ml RELISTOR) for patients weighing 38-61 kg or 12 mg (0.6 ml RELISTOR) for patients weighing 62-114 kg.
Običajni odmerek je 8 mg metilnaltreksonijevega bromida (0, 4 ml zdravila RELISTOR) za bolnike, ki tehtajo 38- 61 kg, ali 12 mg (0, 6 ml zdravila RELISTOR) za bolnike, ki tehtajo 62- 114 kg.
RELISTOR is given by an injection under the skin (by subcutaneous injection) in either (1) your upper legs (thighs), (2) your abdomen (stomach), and (3) your upper arm (if not self-injecting).
Zdravilo RELISTOR se daje kot podkožna injekcija (s subkutano injekcijo) v (1) stegno ali (2) trebuh ali (3) nadlaket (če si zdravila ne injicirate sami).
(See INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF RELISTOR AT THE END OF THIS LEAFLET.)
(Glejte NAVODILA ZA PRIPRAVO IN DAJANJE INJEKCIJE ZDRAVILA RELISTOR na koncu tega navodila za uporabo zdravila).
If you use more RELISTOR than you should
22 Če ste uporabili večji odmerek zdravila RELISTOR, kot bi smeli
If you have used more RELISTOR than you should (either by injecting too much on a single occasion or by using more than one injection in 24 hours), talk to a doctor or pharmacist immediately.
Če ste uporabili več zdravila RELISTOR, kot bi smeli (bodisi z enkratnim vbrizganjem prevelikega odmerka bodisi tako, da ste si dali več kot eno injekcijo v 24 urah), se takoj posvetujte z zdravnikom ali s farmacevtom.
20 If you forget to use RELISTOR
Če ste pozabili uporabiti zdravilo RELISTOR
If you stop using RELISTOR
Če ste prenehali uporabljati zdravilo RELISTOR
If you stop using RELISTOR, talk to a doctor or pharmacist.
Če ste prenehali uporabljati zdravilo RELISTOR, se posvetujte z zdravnikom ali s farmacevtom.
Like all medicines, RELISTOR can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo RELISTOR neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The most common side effects likely to occur in more than 1 in 10 patients:
Najpogostejši neželeni učinki, ki se utegnejo pojaviti pri več kot enem od desetih bolnikov, ki prejemajo zdravilo RELISTOR, so:
• Abdominal pain (belly ache)
• abdominalna bolečina (bolečina v trebuhu),
• Nausea (feeling sick in the stomach)
• navzea (želodčna slabost s siljenjem na bruhanje),
• Flatulence (passing wind)
• vetrovi,
• Diarrhoea (passing of frequent watery stools)
• driska (pogosto odvajanje vodenega blata).
Common side effects reported in more than one in 100 patients, but in less than one in ten patients receiving RELISTOR are:
Pogosta neželena učinka, o katerih poročajo pri več kot enem od sto bolnikov, vendar pri manj kot enem od desetih bolnikov, ki prejemajo zdravilo RELISTOR, sta:
• Dizziness (light-headed)
• vrtoglavost (omotičnost),
• Reaction at the site of injection (e. g., stinging, burning, pain redness, oedema)
• reakcija na mestu injiciranja (npr. zbadanje, pekoč občutek, bolečina, rdečica, oteklina).
HOW TO STORE RELISTOR
SHRANJEVANJE ZDRAVILA RELISTOR
Do not use RELISTOR after the expiry date, which is stated on the carton and vial.
Zdravila RELISTOR ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali.
Only use RELISTOR if the solution is clear, colourless to pale yellow, and does not contain flakes or particles.
23 Uporabljajte zdravilo RELISTOR le, če je raztopina bistra, brezbarvna do svetlo rumena in ne vsebuje kosmičev ali delcev.
The syringe and needle should NEVER be reused.
NIKOLI ne smete brizge in igle uporabiti še enkrat.
Dispose the needle and syringe as instructed by your doctor, nurse or pharmacist.
Zavrzite iglo in brizgo po navodilih svojega zdravnika, medicinske sestre ali farmacevta.
What RELISTOR contains
Kaj vsebuje zdravilo RELISTOR
The other ingredients are sodium chloride, sodium calcium edetate, glycine hydrochloride, water for injections, hydrochloric acid (to adjust pH) and sodium hydroxide (to adjust pH).
Pomožne snovi so natrijev klorid, natrijev kalcijev edetat, glicinklorid, voda za injekcije, klorovodikova kislina (za popravek pH) in natrijev hidroksid (za popravek pH).
What RELISTOR looks like and contents of the pack
Izgled zdravila RELISTOR in vsebina pakiranja
RELISTOR is a solution for injection.
Zdravilo RELISTOR je raztopina za injiciranje.
Each vial contains 0.6 ml of solution.
Ena viala vsebuje 0, 6 ml raztopine.
Packs of more than one vial contain trays consisting of: one vial, one 1 ml injection syringe with retractable injection needle, and two alcohol swabs:
Pakiranja, ki vsebujejo več kot eno vialo, vsebujejo ležišča, ki jih sestavljajo: ena viala, ena 1- mililitrska injekcijska brizga z vskočno injekcijsko iglo in dva alkoholna zloženca.
Single vial
Ena viala.
Pack containing 2 vials, 2 injection syringes with retractable injection needle, and 4 alcohol swabs (i. e.
Škatla, ki vsebuje 2 viali, 2 injekcijski brizgi z vskočno injekcijsko iglo in 4 alkoholne zložence (t. j.
2 trays).
2 ležišči).
Pack containing 7 vials, 7 injection syringes with retractable injection needle, and 14 alcohol swabs (i. e.7 trays).
7 ležišč).
Wyeth Europa Limited Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH United Kingdom Tel:
Wyeth Europa Limited Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH Velika Britanija Tel:
Manufacturer:
24 Izdelovalec:
Via Franco Gorgone Zona Industriale 95030 Catania Italy
Via Franco Gorgone Zona Industriale 95030 Catania Italija
This leaflet was last approved in {MM/ YYYY}.
Navodilo je bilo odobreno {MM / LLLL}.
There are also links to other web sites about rare diseases and treatments.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /, kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
24 INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF RELISTOR
26 NAVODILA ZA PRIPRAVO IN DAJANJE INJEKCIJE ZDRAVILA RELISTOR
Preparing the injection syringe Step 3:
Priprava injekcijske brizge Korak 3:
Choosing and preparing an injection site Step 4a:
Izbira in priprava mesta za injiciranje Korak 4a:
Injecting RELISTOR using a pack containing injection syringe with retractable injection needle Step 4b:
Injiciranje zdravila RELISTOR s pakiranjem, ki vsebuje injekcijsko brizgo z vskočno injekcijsko iglo Korak 4b:
Injecting RELISTOR using a standard injection syringe and injection needle
Injiciranje zdravila RELISTOR s standardno injekcijsko brizgo in injekcijsko iglo
The following instructions explain how to inject RELISTOR.
V teh navodilih boste našli razlago, kako si vbrizgavajte zdravilo RELISTOR.
You will be instructed by your healthcare professional on the techniques of self-administration.
Vaš zdravstveni delavec vas bo naučil metode samoinjiciranja.
You may receive either a pack containing a tray with everything needed for the injection, or a single vial only.
Na voljo imate bodisi škatlo z ležiščem, ki vsebuje vse, kar potrebujete za injiciranje, ali samo eno vialo.
Select a flat, clean, well-lit working surface.
Izberite čisto, dobro osvetljeno ravno delovno površino.
These include the RELISTOR vial, a 1 ml injection syringe (with or without retractable needle), 2 alcohol swabs, and a cotton ball or gauze.
To so viala zdravila RELISTOR, 1- mililitrska injekcijska brizga (z vskočno iglo ali brez nje), 2 alkoholna zloženca in kosem vate ali gaza.
Contact your pharmacist, nurse or physician for assistance.
Obrnite se za pomoč na svojega zdravnika, medicinsko sestro ali farmacevta.
Preparing the injection syringe
Priprava injekcijske brizge
Remove the protective cap from the vial.
Odstranite zaščitno zaporko z viale.
Wipe the vial’ s rubber stopper with an alcohol swab and place it on your flat work surface.
Obrišite gumijasti zamašek viale z alkoholnim zložencem in položite vialo na ravno delovno površino.
Carefully pull the syringe plunger back until the end of the plunger is at the line that represents your dose.
Previdno potegnite bat brizge nazaj, dokler ne bo konec bata pri črtici, ki pomeni vaš odmerek.
If you push the plunger completely, you will hear a ‘ click’ sound.
Če boste potisnili bat do konca navzdol, boste zaslišali klik.
Hold the syringe at eye level and make sure the tip of the needle is in the fluid all of the time.
Držite brizgo v višini oči in se prepričajte, da je konica igle povsem potopljena v tekočini.
Slowly pull the plunger down to the dosage marking on the syringe that matches your dose.
Počasi povlecite bat navzdol do označbe za odmerek na brizgi, ki ustreza vašemu odmerku.
26 Step 3:
28 Korak 3:
Choosing and preparing an injection site
Izbira in priprava mesta injiciranja
The three areas of the body recommended for injection of RELISTOR are:
Za injiciranje zdravila RELISTOR so priporočljiva tri mesta:
(1) your upper legs (thighs), (2) your abdomen (stomach), and (3) your upper arm (if not self injecting).
(1) stegno, (2) trebuh in (3) nadlaket (če si zdravila ne injicirate sami).
To prepare the area of skin where RELISTOR is to be injected, wipe the injection site with an alcohol swab.
Pripravite predel kože, kamor boste injicirali zdravilo RELISTOR, tako da mesto injiciranja obrišete z alkoholnim zložencem.
DO NOT TOUCH THIS AREA AGAIN BEFORE GIVING THE INJECTION.
Nato se ne dotikajte več tega predela, dokler ne boste dali injekcije.
Step 4a:
Korak 4a:
Injecting RELISTOR using a pack containing injection syringe with retractable injection needle
Injiciranje zdravila RELISTOR s pakiranjem, ki vsebuje injekcijsko brizgo z vskočno injekcijsko iglo
Holding the filled syringe with the needle pointing up, recheck the syringe for air bubbles.
Če 1. vidite mehurčke, rahlo potrkajte s prstom po brizgi, da se zračni mehurčki dvignejo na vrh brizge.
Use the other hand to gently pinch the cleaned area of skin and hold it firmly.
Z drugo roko na očiščenem predelu kože nežno naredite 2. kožno gubo in jo čvrsto držite.
Push the needle into the skin at a slight angle (45 degrees) with a quick, short motion.
S hitrim in kratkim gibom potisnite iglo v koži pod rahlim kotom (45 stopinj).
After the needle is inserted, let go of the skin and slowly push the plunger all the way down to inject RELISTOR.
Potem ko ste iglo zabodli, kožo spustite in injicirajte zdravilo RELISTOR, tako da bat previdno potisnete do konca navzdol.
Dispose the syringe in a closable puncture-resistant container as instructed by your healthcare professional.
Zavrzite injekcijsko brizgo v zaprt vsebnik za ostre odpadke, kot vam je naročil vaš zdravstveni delavec.
Step 4b:
29 Korak 4b:
Injecting RELISTOR using a standard injection syringe and injection needle
Injiciranje raztopine zdravila RELISTOR s standardno injekcijsko brizgo in injekcijsko iglo
If there are bubbles, gently tap the syringe with your finger until the air bubbles rise to the top of the syringe.
Če 1. vidite mehurčke, rahlo potrkajte s prstom po brizgi, da se zračni mehurčki dvignejo na vrh brizge.
If needed, you may cover the injection site with a bandage.
Če je treba, ga lahko pokrijete z obvezo.
Remicade is a vial containing a powder to be made up into a solution for infusion.
Zdravilo Remicade je v obliki viale, ki vsebuje prašek za pripravo raztopine za infundiranje.
It contains the active substance infliximab.
Remicade vsebuje zdravilno učinkovino infliksimab.
It is used, most often when other medicines or treatments have failed, in adults with the following diseases: • rheumatoid arthritis (an immune system disease causing inflammation of the joints).
Najpogosteje se uporablja, kadar druga zdravila ali zdravljenja niso bila učinkovita, in sicer pri odraslih z naslednjimi obolenji: • revmatoidnim artritisom (obolenje imunskega sistema, ki povzroča vnetja sklepov).
Remicade is used with methotrexate (a medicine that acts on the immune system), • Crohn’ s disease (a disease causing inflammation of the digestive tract), when the disease is severe or fistulising(with the formation of fistulae, abnormal passageways between the gut and other organs), • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut), • ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine), • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints), • psoriasis (a disease causing red, scaly patches on the skin).
Zdravilo Remicade se uporablja skupaj z metotreksatom (zdravilom, ki učinkuje na imunski sistem). • Crohnovo boleznijo (obolenje, ki povzroča vnetje prebavnega trakta), kadar je obolenje močno izraženo ali pa prihaja do fistulizacije (s pojavljanjem fistul, nenormalnih prehodov med črevesjem in drugimi organi), • ulceroznim kolitisom (obolenje, ki povzroča vnetje in pojavljanje razjed v oblogah, ki obdajajo črevesje), • ankilozirajočim spondilitisom (obolenje, ki povzroča vnetje in bolečine v sklepih v hrbtenici), • psoriatičnim artritisom (obolenje, ki povzroča rdeče, luskaste zaplate na koži in vnetje sklepov), • psoriazo (obolenje, ki povzroča rdeče, luskaste zaplate na koži).
See the Summary of Products Characteristics (also part of the EPAR) for full details.
Za vse podrobnosti glejte Povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
Remicade must be given under the supervision and monitoring of a specialised doctor who has experience in the diagnosis and treatment of the diseases Remicade can be used to treat.
Dajanje zdravila Remicade mora nadzirati in spremljati specializirani zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem obolenj, za zdravljenje katerih se lahko uporablja zdravilo Remicade.
Remicade is usually given as 3 mg per kilogram bodyweight in rheumatoid arthritis, although the dose can be increased if necessary.
Zdravilo Remicade se pri revmatoidnem artritisu običajno daje v odmerku 3 mg na kilogram telesne mase, vendar pa se odmerek lahko poveča, če je to potrebno.
How often the treatment is repeated depends on the disease being treated, and on the patient’ s response to the medicine.
Kako pogosto je treba zdravljenje ponavljati, je odvisno od obolenja, ki se ga zdravi, in od bolnikovega odziva na zdravilo.
Remicade is given by intravenous infusion (drip into a vein) over 2 hours.
Zdravilo Remicade se daje z intravenskim infundiranjem (kapalno infuzijo v veno) v trajanju dveh ur.
All patients are monitored for any reactions during the infusion and for at least 1 to 2 hours afterwards.
Pri vseh bolnikih je treba preverjati, ali med infundiranjem in še najmanj 1 do 2 uri po njem morebiti ni prišlo do pojava kakršnih koli reakcij.
They may be given other medicines before or during treatment with Remicade to reduce the risk of infusion-related reactions.
Pred ali med zdravljenjem z zdravilom Remicade je bolnikom mogoče dati druga zdravila za zmanjšanje tveganja za pojav reakcij, povezanih z infundiranjem.
For more information, see the Package Leaflet.
Za več informacij glejte Navodilo za uporabo zdravila.
Patients who take Remicade must be given the special alert card that summarises the safety information about the medicine.
Bolnikom, ki prejemajo zdravilo Remicade, je treba dati posebno opozorilno kartico, v kateri so zbrani podatki o varni uporabi zdravila.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How does Remicade work?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako zdravilo Remicade deluje?
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind 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 in se veže na posebno strukturo (imenovano antigen), ki se nahaja v telesu.
Infliximab has been designed to bind to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha).
Infliksimab je bil zasnovan tako, da se v telesu veže na kemijski prenašalec, imenovan tumorski nekrozni faktor (TNF- alfa).
By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of the diseases.
Z blokiranjem faktorja TNF- alfa infliksimab izboljša stanje, kar zadeva vnetje, in druge simptome obolenj.
Remicade has been studied in a total of 1,432 patients in two studies for the treatment of rheumatoid arthritis.
Zdravilo Remicade so pri zdravljenju revmatoidnega artritisa raziskovali v dveh študijah pri skupno 1432 bolnikih.
Remicade was given with methotrexate and compared with methotrexate alone.
Zdravilo Remicade so dajali skupaj z metotreksatom, primerjali pa so ga z metotreksatom kot samostojnim zdravilom.
The main measure of effectiveness was the improvement in the signs and symptoms of rheumatoid arthritis, joint damage and the patients’ physical function after up to 54 weeks.
Najpomembnejše merilo učinkovitosti je bilo izboljšanje znakov in simptomov revmatoidnega artritisa, izboljšanje v zvezi z poškodbami sklepov in izboljšanje bolnikovih fizičnih zmogljivosti po obdobju, ki je trajalo do 54 tednov.
For Crohn’ s disease, Remicade has been compared with placebo (a dummy treatment) in 1,090 patients in four studies.
Pri Crohnovi bolezni so zdravilo Remicade primerjali s placebom (zdravilom brez zdravilne učinkovine) pri 1090 bolnikih v štirih študijah.
The main measures of effectiveness were the improvement in the severity of symptoms or the healing of fistulae.
Najpomembnejše merilo učinkovitosti je bilo izboljšanje v zvezi z izraženostjo simptomov ali pa ozdravitev fistule.