natgillin/translations-raw huggingface dataset:
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠ ANJE SERIJE
Name and address of the manufacturers responsible for batch release
Ime in naslov izdelovalca, odgovornega za sproš anje serije
• CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN U INKOVITO UPORABO ZDRAVILA
LABELLING
OZNA EVANJE IN NAVODILO ZA UPORABO
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
OZNA EVANJE
BOTTLE LABEL, BOTTLE CARTON:
OZNAKA NA STEKLENI KI, ŠKATLA STEKLENI KE:
EU/ 1/ 98/ 074/ 001 14 film coated tablets EU/ 1/ 98/ 074/ 002 28 film coated tablets EU/ 1/ 98/ 074/ 003 84 film coated tablets
EU/ 1/ 98/ 074/ 001 14 filmsko obloženih tablet EU/ 1/ 98/ 074/ 002 28 filmsko obloženih tablet EU/ 1/ 98/ 074/ 003 84 filmsko obloženih tablet
20 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (ALL BLISTER PACKS):
21 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU PRETISNI OMOT (VSE VELIKOSTI PAKIRANJ PRETISNIH OMOTOV):
OPTRUMA 60 mg film coated tablets raloxifene hydrochloride
OPTRUMA 60 mg filmsko obložene tablete (raloksifenijev klorid)
Read all of this leaflet carefully before you start taking your medicine. • Keep this leaflet.
Pred za etkom jemanja natan no preberete navodilo! • Navodilo shranite.
Do not pass it on to others.
Morda ga boste želeli ponovno prebrati. • e imate dodatna vprašanja se posvetujte z zdravnikom ali s farmacevtom. • Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Njim bi lahko celo škodovalo, eprav imajo znake bolezni, podobne vašim. • e katerikoli neželeni u inek postane resen ali e opazite katerikoli neželeni u inek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
What OPTRUMA is and what it is used for 2.
Kaj je zdravilo OPTRUMA in za kaj ga uporabljamo 2.
Before you take OPTRUMA 3.
Kaj morate vedeti, preden boste vzeli zdravilo OPTRUMA 3.
How to take OPTRUMA 4.
Kako jemati zdravilo OPTRUMA 4.
Possible side effects 5.
Možni neželeni u inki 5.
How to store OPTRUMA 6.
Shranjevanje zdravila OPTRUMA 6.
WHAT OPTRUMA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO OPTRUMA IN ZA KAJ GA UPORABLJAMO
OPTRUMA belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs).
Zdravilo OPTRUMA sodi v skupino nehormonskih zdravil, imenovano selektivni modulatorji estrogenskega receptorja.
OPTRUMA mimics some of the helpful effects of oestrogen after the menopause.
Po menopavzi zdravilo OPTRUMA posnema nekatere koristne u inke estrogena.
OPTRUMA is used to treat and prevent osteoporosis in postmenopausal women.
Zdravilo OPTRUMA se uporablja za zdravljenje in prepre evanje osteoporoze pri ženskah po menopavzi.
OPTRUMA reduces the risk of vertebral fractures in women with postmenopausal osteoporosis.
Pri ženskah s postmenopavzalno osteoporozo zdravilo OPTRUMA zmanjša tveganje za zlome vretenc.
Although it may have no symptoms at first, osteoporosis makes you more likely to break bones, especially in your spine, hips and wrists and may cause back pain, loss of height and a curved back.
Še posebej pogosta je pri ženskah po menopavzi. etudi morda sprva ni nobenih simptomov, se zaradi osteoporoze pove a verjetnost zlomov kosti, še posebej v hrbtenici, kolku in zapestju, lahko pa povzro i tudi bole ine v hrbtu, zmanjšanje telesne višine in upognjenost hrbta.
BEFORE YOU TAKE OPTRUMA
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO OPTRUMA
Do not take OPTRUMA:
Ne jemljite zdravila OPTRUMA
• If you are allergic (hypersensitive) to raloxifene or any of the ingredients of OPTRUMA. • If there is still a possibility that you can get pregnant, OPTRUMA could harm your unborn child. • If you are being treated or have been treated for blood clots (deep vein thrombosis, pulmonary embolism or retinal vein thrombosis). • If you have liver disease (examples of liver disease include cirrhosis, mild hepatic impairment or cholestatic jaundice). • If you have any unexplained vaginal bleeding.
• e ste alergi ni na (preob utljivi za) raloksifen ali katerokoli sestavino zdravila OPTRUMA. • e je še vedno možnost, da lahko zanosite, saj zdravilo OPTRUMA lahko poškoduje vašega nerojenega otroka. • e vas trenutno zdravijo zaradi krvnih strdkov ali so vas v preteklosti zdravili zaradi teh motenj (tromboza globokih ven, plju na embolija ali tromboza retinalnih ven). • e imate bolezen jeter (jetrne bolezni so na primer ciroza, blaga okvara jeter ali holestatska zlatenica). • e imate kakršnokoli nerazložljivo krvavitev iz nožnice.
This must be investigated by your doctor. • If you have active uterine cancer, as there is insufficient experience of OPTRUMA use in women with this disease. • If you have severe kidney problems.
V tem primeru vas mora pregledati vaš zdravnik. • e imate aktivni rak maternice, saj pri ženskah s to boleznijo ni zadostnih izkušenj z uporabo zdravila OPTRUMA. • e imate hude težave z ledvicami.
23 Take special care with OPTRUMA
24 Bodite posebno pozorni pri jemanju zdravila OPTRUMA
If any of them apply to you, talk to your doctor before you take the medicine.
V nadaljevanju navajamo nekaj možnih razlogov, zaradi katerih zdravljenje s tem zdravilom ne bi bilo primerno za vas. e katerikoli od njih velja za vas, se morate pogovoriti s svojim zdravnikom, še preden za nete jemati zdravilo.
• If you are immobilised for some time such as being wheel-chair bound, needing to be admitted to a hospital or having to stay in bed while recovering from an operation or an unexpected illness. • If you are receiving oral oestrogen therapy • If you are suffering from breast cancer, as there is insufficient experience of OPTRUMA use in women with this disease. • If you have had a cerebrovascular accident (e. g. stroke), or if your doctor has told you that you are at high risk of having one.
• e ste dalj asa nepokretni, denimo uporabljate invalidski vozi ek, ste bili sprejeti v bolnišnico ali ležite v postelji pri okrevanju po operaciji ali zaradi nepri akovane bolezni. • e prejemate peroralno estrogensko terapijo. • e imate raka dojke, ker ni zadosti izkušenj z uporabo zdravila OPTRUMA pri ženskah s to boleznijo. • e ste že imeli cerebrovaskularni dogodek (npr. kap) ali e vam je vaš zdravnik povedal, da imate visoko tveganje za tak dogodek.
You should have this investigated by your doctor.
Malo verjetno je, da bi zdravilo OPTRUMA povzro ilo krvavitev iz nožnice, zato je vsaka krvavitev iz nožnice v asu jemanja zdravila OPTRUMA nepri akovana in morate prositi svojega zdravnika, naj vas pregleda.
OPTRUMA does not treat postmenopausal symptoms, such as hot flushes.
Zdravilo OPTRUMA ne zdravi postmenopavzalnih simptomov, kakor so navali vro ine.
OPTRUMA lowers total cholesterol and LDL ("bad") cholesterol.
Zdravilo OPTRUMA znižuje vrednost celokupnega holesterola in LDL ('splošno ne vpliva na trigliceride ali HDL ('
In general, it does not change triglycerides or HDL ("good") cholesterol.
Na)
However, if you have taken oestrogen in the past and had extreme elevations in triglycerides, you should talk to your doctor before taking OPTRUMA.
dobri' holesterol. e ste v preteklosti že jemali estrogene) in ob tem imeli mo no povišane vrednosti trigliceridov, se pred jemanjem zdravila OPTRUMA pogovorite s svojim zdravnikom.
If you are taking digitalis medicines for your heart or anticoagulants like warfarin to thin your blood, your doctor may need to adjust your dose of these medicines.
e jemljete zdravila za srce, ki vsebujejo digitalis, ali antikoagulante za red enje krvi, kakor je npr. varfarin, vam bo vaš zdravnik morda moral prilagoditi odmerek teh zdravil.
Tell your doctor if you are taking cholestyramine which is mainly used as lipid-lowering medicine.
Obvestite svojega zdravnika, e jemljete holestiramin, ki se uporablja predvsem kot zdravilo za zniževanje koncentracij lipidov v krvi.
Pregnancy and breast-feeding OPTRUMA is for use only by postmenopausal women and must not be taken by women who could still have a baby.
Nose nost in dojenje Zdravilo OPTRUMA je namenjena le ženskam po menopavzi in je ne smejo jemati ženske, ki bi še lahko zanosile.
Optruma could harm your unborn child.
Zdravilo OPTRUMA lahko poškoduje vašega nerojenega otroka.
Do not take OPTRUMA if you are breast-feeding as it might be excreted in mother 'milk. s
Ne jemljite zdravila OPTRUMA, e dojite, saj lahko zdravilo prehaja v materino mleko.
OPTRUMA has no known effects on driving or using machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo OPTRUMA nima znanih u inkov na vožnjo ali upravljanje s stroji.
If you have been told by your doctor that you have an intolerance to lactose, a type of sugar, contact your doctor before taking this medicinal product..
Pomembne informacije o nekaterih sestavinah zdravila OPTRUMA e vam je vaš zdravnik povedal, da imate netoleranco za laktozo, ki je vrsta sladkorja, obvestite zdravnika, preden za nete jemati ta medicinski proizvod.
HOW TO TAKE OPTRUMA
KAKO JEMATI ZDRAVILO OPTRUMA
You should check with your doctor or pharmacist if you are not sure.
Pri jemanju tega zdravila natan no upoštevajte zdravnikova navodila. e ste negotovi, se posvetujte z zdravnikom ali s farmacevtom.
The dose is one tablet a day.
25 Obi ajen odmerek zdravila je ena tableta na dan.
It does not matter what time of day you take your tablet but taking the tablet at the same time each day will help you remember to take it.
Ni pomembno, ob katerem asu jo vzamete, vendar vam bo jemanje vsak dan ob istem asu pomagalo, da se spomnite, da morate vzeti zdravilo.
If you wish you may take a glass of water with it.
Tableto pogoltnite celo. e želite, jo lahko popijete s teko ino.
Your doctor will tell you how long you should continue to take OPTRUMA.
Vaš zdravnik vam bo povedal, kako dolgo naj bi jemali zdravilo OPTRUMA.
You should talk to your doctor first.
e ste prenehali jemati zdravilo OPTRUMA Predhodno se posvetujte s svojim zdravnikom.
If you have the impression that the effect of this product is too strong or too weak, talk to your doctor or pharmacist.
e menite, da je u inek tega zdravila premo an ali prešibak, se posvetujte s svojim zdravnikom ali farmacevtom.
Take a tablet as soon as you remember and then continue as before.
e ste pozabili vzeti zdravilo OPTRUMA Vzemite eno tableto takoj, ko se spomnite, in potem nadaljujte enako kot prej.
Tell your doctor or pharmacist.
e ste vzeli ve ji odmerek zdravila OPTRUMA, kot bi smeli Povejte svojemu zdravniku ali farmacevtu.
Like all medicines, OPTRUMA can cause side effects although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo OPTRUMA neželene u inke, ki pa se ne pojavijo pri vseh bolnikih.
The majority of side effects seen with OPTRUMA have been mild.
Neželeni u inki, ki so jih opažali pri zdravilu OPTRUMA, so bili ve inoma blagi.
The most common side effects (affects more than 1 user in 10) are: • Hot flushes (vasodilatation) • Flu syndrome
Najpogostejši neželeni u inki (prizadanejo ve kot 1 uporabnika od 10) so: • Navali vro ine (vazodilatacija) • Sindrom gripe
Common side effects (affects 1 to 10 users in 100) are: • Leg cramps • Swelling of hands, feet and legs (peripheral oedema) • Gallstones
Pogosti neželeni u inki (prizadanejo 1 do 10 uporabnikov od 100) so: • Kr i v nogah • Otekanje dlani, stopal in nog (periferni edem) • Žol ni kamni
Uncommon side effects (affects 1 to 10 users in 1000) are: • Increased risk of blood clots in the legs (deep vein thrombosis) • Increased risk of blood clots in the lungs (pulmonary embolism) • Increased risk of blood clots in the eyes (retinal vein thrombosis) • Skin around the vein is red and painful (superficial vein thrombophlebitis)
Ob asni neželeni u inki (prizadanejo 1 do 10 uporabnikov od 1. 000) so: • Pove ano tveganje krvnih strdkov v nogah (globoka venska tromboza) • Pove ano tveganje krvnih strdkov v plju ih (plju na embolija) • Pove ano tveganje krvnih strdkov v o eh (tromboza retinalnih ven) • Koža okrog ven je rde a in bole a (tromboflebitis povrhnjih ven)
Very rare side effects (affects less than 1 user in 10,000) are: • Rash • Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset • Increased blood pressure • Decrease in the number of the platelets in the blood • Blood clot in an artery (for example stroke) • Headache including migraine • Mild breast symptoms such as pain, enlargement and tenderness
Zelo redki neželeni u inki (prizadanejo manj kot 1 uporabnika od 10. 000) so: • Izpuš aj • Gastrointestinalni simptomi kot so slabost, bruhanje, bole ina v trebuhu in razdražen želodec • Povišan krvni tlak • Zmanjšanje števila krvnih ploš ic v krvi • Krvni strdek v arteriji (na primer kap) • Glavobol vklju no z migreno • Blagi simptomi dojk kot so bole ina, pove anje in ob utljivost
In rare cases, blood levels of liver enzymes may increase during treatment with OPTRUMA.
V redkih primerih se lahko med zdravljenjem z EVISTO zvišajo koncentracije jetrnih encimov v krvi.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
26 e katerikoli neželeni u inek postane resen ali e opazite katerikoli neželeni u inek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE OPTRUMA
SHRANJEVANJE ZDRAVILA OPTRUMA
Medicines should not be disposed of via wastewater or household waste.
Zdravila ne smete odvre i v odpadne vode ali med gospodinjske odpadke.
What OPTRUMA contains
Kaj vsebuje zdravilo OPTRUMA
- The active substance is raloxifene hydrochloride.
- Zdravilna u inkovina je raloksifenijev klorid.
- The other ingredients of OPTRUMA tablets are:
- Pomožne snovi tablet OPTRUMA so:
Shellac, propylene glycol, indigo carmine (E 132).
Obloga tablete: titanov dioksid (E171), polisorbat 80, hipromeloza, makrogol 400, karnauba vosek. rnilo: šelak, propilenglikol, indigotin (E132).
What OPTRUMA looks like and contents of the pack OPTRUMA are white, oval, film coated tablets which are marked with the number 4165.
Izgled zdravila OPTRUMA in vsebina pakiranja OPTRUMA so bele, ovalne, filmsko obložene tablete, ki so ozna ene s številko 4165.
They are packed in blisters or in plastic bottles.
Pakirane so v pretisnih omotih ali plasti nih stekleni kah.
The blister boxes contain 14, 28, or 84 tablets.
Škatle s pretisnimi omoti vsebujejo po 14, 28 ali 84 tablet.
The bottles contain 100 tablets.
Stekleni ke vsebujejo po 100 tablet.
Marketing Authorisation Holder Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
Imetnik dovoljenja za promet Eli Lilly Nederland BV, Grootslag 1- 5, NL- 3991 RA Houten, Nizozemska.
26 For any information about this medicinal product, please contact the representative of Eli Lilly in your country:
27 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo Eli Lilly v vaši državi:
.!. ".!.
...
#$: +30 210 629 4600
!: + 30 2 10 629 4600 "
Italia A Menarini Industrie Farmaceutiche Riunite s. r. l Tel: +39-055 56801
Menarini
Suomi/ Finland Oy Eli Lilly Finland Ab Puh/ Tel: + 358-(0) 9 85 45 250
Suomi/ Finland Oy Eli Lilly Finland Ab
27 Sverige Phadisco Ltd #$: +357 22 715000
Sverige Phadisco Ltd!: +357 22 715000 "
Latvija Eli Lilly Holdings Limited p%rst%vniec & ba Latvij% Tel: +371 67364000
28 Latvija Eli Lilly Holdings Limited p# rst# vniec$ba Latvij # Tel: +371 67364000
Lietuva Eli Lilly Holdings Limited atstovyb 'Tel. +370 (5) 2649600
Lietuva Eli Lilly Holdings Limited atstovyb% Tel. +370 (5) 2649600
London, 26 January 2006 Doc. Ref.
London, 26. januar 2006 Sklic dok.
EMEA/ 282451/ 2008
EMEA/ 604222/ 2007
Rubitecan
Mednarodno nelastniško ime (INN): rubitekan
On 19 January 2006, EuroGen Pharmaceuticals Ltd officially notified the Agency’ s Committee for Medicinal Products for Human Use (CHMP) of its decision to withdraw its application for marketing authorisation for the medicinal product orathecin (rubitecan).
Podjetje EuroGen Pharmaceuticals Ltd je 19. januarja 2006 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji, da so se odločili umakniti vlogo za dovoljenje za promet z zdravilom Orathecin (rubitekan).
Orathecin contains 0.5 or 1.25 of the active substance rubitecan.
Zdravilo Orathecin vsebuje 0, 5 mg ali 1, 25 mg zdravilne učinkovine rubitekan.
This protein is called topoisomerase I.
Tej beljakovini pravimo topoizomeraza I.
By blocking this protein, Orathecin is expected to damage the cancer cells.
Z blokiranjem te beljakovine naj bi zdravilo Orathecin poškodovalo rakave celice.
The studies looked at how long the patients survived after receiving orathecin, compared to those receiving the standard medicines used to treat pancreatic cancer, including 5-fluorouracil (5-FU) or gemcitabine.
V raziskavah so ugotavljali, kako dolgo so bolniki preživeli, če so prejemali zdravilo Orathecin.
Orathecin was given to the patients until their cancer progressed or they could not tolerate the treatment anymore.
Čas preživetja teh bolnikov so primerjali s časom preživetja bolnikov, ki so prejemali zdravila, ki se običajno uporabljajo za zdravljenje raka trebušne slinavke, med drugim 5- fluorouracil (5- FU) ali gemcitabin.
Following CHMP opinion, it usually takes around 2 months to the European Commission to give a licence.
Ko podjetje pripravi odgovore na vprašanja, jih CHMP pregleda in pred izdajo mnenja lahko zaprosi podjetje še za
(44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged The application was at Day 172 days, when the Company withdrew it.
Podjetje je umaknilo vlogo na dan 172.
Based on the review of the data and the Company’ s response to the CHMP list of questions, at the time the withdrawal, the CHMP had concerns and was of the provisional opinion that Orathecin could not be approved for treatment of patients with advanced or metastatic pancretic cancer.
Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj, ki jih je zastavil CHMP, je imel Odbor v času umika vloge zadržke in bil začasnega mnenja, da za zdravilo ni mogoče odobriti dovoljenja za zdravljenje bolnikov z napredovalim ali metastatskim rakom trebušne slinavke.
Therefore, at the time of the withdrawal, the CHMP’ s view was that the benefit had not been sufficiently demonstrated and did not outweigh the identified risks.
Zato je bil v času umika CHMP mnenja, da koristni učinki niso bili zadostno dokazani in niso večji od znanih tveganj.
What is ORENCIA?
Kaj je zdravilo ORENCIA?
ORENCIA is a vial containing a powder to be made up into a solution for infusion.
ORENCIA je zdravilo v obliki viale, ki vsebuje prašek za pripravo raztopine za infudiranje.
Each vial contains 250 mg of the active substance abatacept.
Vsaka viala vsebuje 250 mg zdravilne učinkovine abatacept.
What is ORENCIA used for?
Za kaj se zdravilo ORENCIA uporablja?
ORENCIA is an anti-inflammatory medicine that is used in combination with methotrexate (another medicine that acts on the immune system) to treat adults with moderate to severe active rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints).
Zdravilo ORENCIA je protivnetno zdravilo, ki se uporablja v kombinaciji z metotreksatom (drugim zdravilom, ki učinkuje na imunski sistem) pri zdravljenju odraslih z zmernim do hudim aktivnim revmatoidnim artritisom (boleznijo imunskega sistema, ki povzroča poškodbe in vnetje sklepov).
ORENCIA is used in patients who have not had a sufficient response to other medicines for rheumatoid arthritis including at least one ‘ tumour necrosis factor (TNF) blocker’, or who cannot be given these medicines.
Zdravilo ORENCIA se uporablja pri bolnikih, ki se niso zadostno odzvali na druga zdravila za zdravljenje revmatoidnega artritisa, med drugim na vsaj enega „ zaviralca faktorja tumorske nekroze (TNF) “, ali pri bolnikih, katerim teh zdravil ni mogoče dajati.
How is ORENCIA used?
Kako se zdravilo ORENCIA uporablja?
Treatment with ORENCIA should be initiated and supervised by a specialised doctor who has experience in the diagnosis and treatment of rheumatoid arthritis.
Zdravljenje z zdravilom ORENCIA mora uvesti in nadzorovati zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem revmatoidnega artritisa.
ORENCIA is given as an intravenous infusion (drip into a vein) of 500, 750 or 1,000 mg over 30 minutes.
Zdravilo ORENCIA se daje kot intravenska infuzija (kapalna infuzija v veno) v odmerku 500, 750 ali 1. 000 mg v trajanju 30 minut.
The dose to use depends on the patient’ s weight.
Uporabljeni odmerek je odvisen od bolnikove telesne mase.
It is given every two weeks in the first month (3 doses), then every 4 weeks.
Prvi mesec se zdravilo daje vsaka dva tedna (3 odmerki), nato vsake 4 tedne.
If there is no response within 6 months, doctors should consider the benefits and risks of continuing treatment, and consider alternative treatments.
Če v 6 mesecih ni odziva, mora zdravnik presoditi koristi in tveganja nadaljnjega zdravljenja ter razmisliti o alternativnem zdravljenju.
How does ORENCIA work?
Kako zdravilo ORENCIA deluje?
The active substance in ORENCIA, abatacept, is a protein that has been designed to suppress the activity of ‘ T-cells’, specific cells in the immune system (the body’ s defence system) that are involved in causing inflammation and joint damage in rheumatoid arthritis.
Zdravilna učinkovina zdravila ORENCIA, abatacept, je beljakovina, zasnovana za zaviranje aktivnosti „ T- celic “, specifičnih celic v imunskem sistemu (obrambnem sistemu telesa), ki sodelujejo pri povzročanju vnetja in poškodb sklepov pri revmatoidnem artritisu.
T-cells must be ‘ activated ’ before they work.
T- celice morajo biti „ aktivirane “, preden začnejo učinkovati.
This happens when some molecules (‘ signals’) bind to receptors on the surface of the T-cell.
To se zgodi, ko se nekatere molekule („ signali “) vežejo na receptorje na površini T- celice.
Abatacept has been designed to bind to two of these molecules (CD80 and CD86), preventing them from activating the T-cells.
Abatacept je zasnovan tako, da se veže na dve izmed teh molekul (CD80 in CD86) in jima prepreči, da bi aktivirali T- celice.
This helps to reduce inflammation, improving the joint damage and other symptoms of the disease.
To pomaga zmanjšati vnetje, lajša poškodbe sklepov in druge simptome bolezni.
Abatacept is produced by a method known as ‘ recombinant DNA technology’.
Abatacept se proizvaja po metodi, imenovani „ tehnologija rekombinantne DNA “.
It is made by a cell that has received a gene (DNA), which makes it able to produce abatacept.
Tvori ga celica, ki je prejela gen (DNA), kar ji omogoča tvorjenje abatacepta.
(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 has ORENCIA been studied?
(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 je bilo zdravilo ORENCIA raziskano?
The effects of ORENCIA were first tested in experimental models before being studied in humans.
Učinki zdravila ORENCIA so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
ORENCIA has been studied in three main studies involving 1,382 patients with rheumatoid arthritis.
Zdravilo ORENCIA so preučevali v treh glavnih študijah, ki so zajele 1. 382 bolnikov z revmatoidnim artritisom.