natgillin/translations-raw huggingface dataset:
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Myderison do not outweigh its risks, and the marketing authorisation granted in Hungary cannot be recognised in other Member States of the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje znotraj agencije, je zaključil, da koristi zdravila Myderison ne odtehtajo z njim povezana tveganja in da se dovoljenje za promet z zdravilom, ki je bilo odobreno na Madžarskem, ne more priznati v drugih državah članicah Evropske unije.
Dr Ondřej Slanař (Czech Republic)
dr. Ondřej Slanař (Češka republika) Datum začetka napotitvenega postopka: 22. januar 2009 Odgovori družbe, poslani dne:
Further information on Tovanor Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Tovanor Breezhaler so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Therefore, the Agency decided that Tovanor Breezhaler's benefits are greater than its risks and it can be authorised for use in the EU.
Zato je agencija zaključila, da so koristi zdravila Tovanor Breezhaler večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The most common side effects with Tovanor Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting).
Najpogostejši neželeni učinki zdravila Tovanor Breezhaler (opaženi pri več kot 1 bolniku od 100) so suha usta, nazofaringitis (vnetje nosu in žrela), nespečnost (težave s spanjem), bolečine v mišicah in kosteh ter gastroenteritis (driska in bruhanje).
After 12 weeks of treatment, Tovanor Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.
Po 12 tednih zdravljenja je bilo povečanje vrednosti FEV1 pri uporabi zdravila Tovanor Breezhaler v prvi študiji za 97 ml večje kot pri uporabi placeba, v drugi pa za 108 ml.
Tovanor Breezhaler (glycopyrronium bromide) EMA/326862/2018
Tovanor Breezhaler(glikopironijev bromid) EMA/326862/2018
The European Medicines Agency noted that Tovanor Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and also improved the symptoms of COPD.
Evropska agencija za zdravila je menila, da ima zdravilo Tovanor Breezhaler zmerno vendar pomembno korist za bolnike v smislu izboljšanja delovanja pljuč in da izboljšuje simptome KOPB.
Side effects reported with Tovanor Breezhaler are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Tovanor Breezhaler, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What measures are being taken to ensure the safe and effective use of Tovanor Breezhaler?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tovanor Breezhaler?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tovanor Breezhaler have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Tovanor Breezhaler upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about using Tovanor Breezhaler, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Tovanor Breezhaler glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Tovanor Breezhaler capsules, which contain a powder for inhalation, are only used with the Tovanor Breezhaler inhaler and must not be swallowed.
Kapsule zdravila Tovanor Breezhaler, ki vsebujejo prašek za inhaliranje, je treba uporabljati izključno z inhalatorjem za zdravilo Tovanor Breezhaler in se jih ne sme pogoltniti.
As for all medicines, data on the use of Tovanor Breezhaler are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Tovanor Breezhaler stalno spremljajo.
Tovanor Breezhaler is used for maintenance (regular) treatment.
Zdravilo Tovanor Breezhaler se uporablja za vzdrževalno (redno) zdravljenje
Tovanor Breezhaler received a marketing authorisation valid throughout the EU on 28 September
Za zdravilo Tovanor Breezhaler je bilo 28. septembra 2012 izdano dovoljenje za promet, veljavno po vsej EU.
Tovanor Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD.
Zdravilo Tovanor Breezhaler je bilo učinkovitejše od placeba (zdravila brez zdravilne učinkovine) pri lajšanju simptomov KOPB v dveh glavnih študijah, v kateri je sodelovalo skupno 1 888 bolnikov s
Why is Tovanor Breezhaler authorised in the EU?
Zakaj je bilo zdravilo Tovanor Breezhaler odobreno v EU?
An overview of Tovanor Breezhaler and why it is authorised in the EU
Pregled zdravila Tovanor Breezhaler in zakaj je odobreno v EU
Tovanor Breezhaler is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Zdravilo Tovanor Breezhaler se uporablja za lajšanje simptomov kronične obstruktivne pljučne bolezni (KOPB) pri odraslih.
In addition, there were no major safety concerns with Tovanor Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines.
Poleg tega ni ugotovila nobenih zadržkov glede varnosti zdravila Tovanor Breezhaler, njegovi neželeni učinki pa so podobni tistim, ki so značilni za ostale antagoniste muskarinskih receptorjev.
Other information about Tovanor Breezhaler
Druge informacije o zdravilu Tovanor Breezhaler
Tovanor Breezhaler (glycopyrronium bromide)
Tovanor Breezhaler(glikopironijev bromid)
What is Tovanor Breezhaler and what is it used for?
Kaj je zdravilo Tovanor Breezhaler in za kaj se uporablja?
What benefits of Tovanor Breezhaler have been shown in studies?
Kakšne koristi je zdravilo Tovanor Breezhaler izkazalo v študijah?
The active substance in Tovanor Breezhaler, glycopyrronium bromide, is a muscarinic receptor antagonist.
Zdravilna učinkovina v zdravilu Tovanor Breezhaler, glikopironijev bromid, je antagonist muskarinskih receptorjev.
What are the risks associated with Tovanor Breezhaler?
Kakšna tveganja so povezana z zdravilom Tovanor Breezhaler?
For the full list of all side effects and restrictions with Tovanor Breezhaler, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Tovanor Breezhaler glejte navodilo za uporabo.
Muscarinic receptors control the contraction of muscles and when glycopyrronium bromide is inhaled, it relaxes the muscles of the airways.
Muskarinski receptorji nadzirajo krčenje mišic in ob vdihu glikopironijevega bromida se mišice dihalnih poti sprostijo, zaradi česar ostanejo dihalne poti odprte, kar bolniku omogoča lažje dihanje.
Tovanor Breezhaler can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Tovanor Breezhaler je le na recept.
How does Tovanor Breezhaler work?
Kako zdravilo Tovanor Breezhaler deluje?
How is Tovanor Breezhaler used?
Kako se zdravilo Tovanor Breezhaler uporablja?
Tovanor Breezhaler contains the active substance glycopyrronium bromide.
Vsebuje zdravilno učinkovino glikopironijev bromid.
In some circumstances, it can be given by injection into a vein.
V nekaterih primerih ga je mogoče v veno dati tudi z injekcijo.
What measures are being taken to ensure the safe and effective use of Parsabiv?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Parsabiv?
The full EPAR for Parsabiv can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Parsabiv je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The main measure of effectiveness was a reduction in parathyroid hormone by more than 30% after at least 20 weeks of treatment.
Glavno merilo učinkovitosti je bilo znižanje ravni paratiroidnega hormona za več kot 30 % po vsaj 20 tednih zdravljenja.
This is a summary of the European public assessment report (EPAR) for Parsabiv.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Parsabiv.
Other information about Parsabiv
Druge informacije o zdravilu Parsabiv
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Parsabiv's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Parsabiv večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
In all three studies, Parsabiv was given for 26 weeks.
V vseh treh študijah je bilo zdravilo Parsabiv dajano 26 tednov.
What is Parsabiv and what is it used for?
Kaj je zdravilo Parsabiv in za kaj se uporablja?
It is not intended to provide practical advice on how to use Parsabiv.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Treatment is started at a dose of 5 mg three times a week and the dose is then adjusted according to the patient's parathyroid hormone level or calcium level.
Začetni odmerek pri zdravljenju znaša 5 mg trikrat na teden, odmerek pa je nato prilagojen glede na bolnikovo raven paratiroidnega hormona ali raven kalcija.
The most common side effects with Parsabiv (which may affect more than 1 in 10 people) are low calcium level in the blood, muscle spasm, diarrhoea, nausea (feeling sick) and vomiting.
Najpogostejši neželeni učinki zdravila Parsabiv (ki se lahko pojavijo pri več kot 1 bolniku od 10) so nizka raven kalcija v krvi, mišični krči, driska, navzeja (slabost) in bruhanje.
What are the risks associated with Parsabiv?
Kakšna tveganja so povezana z zdravilom Parsabiv?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Parsabiv have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Parsabiv upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about treatment with Parsabiv, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Parsabiv preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What benefits of Parsabiv have been shown in studies?
Kakšne koristi je zdravilo Parsabiv izkazalo v študijah?
For practical information about using Parsabiv, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Parsabiv naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
It is given at the end of a haemodialysis session into the line that leads back from the dialysis machine to the patient's vein.
Dan je ob koncu hemodializnega postopka, prek linije, ki od dializnega aparata vodi nazaj v bolnikovo veno.
It contains the active substance etelcalcetide.
Vsebuje zdravilno učinkovino etelkalcetid.
In the third study, Parsabiv was found to be at least as effective as cinacalcet: in 68% (232 out of 340) patients given Parsabiv compared with 58% (198 out of 343) patients given cinacalcet.
V tretji študiji je bilo ugotovljeno, da je zdravilo Parsabiv vsaj tako učinkovito kot cinakalcet: v primerjavi z 58 % (198 od 343) bolnikov, ki so prejemali placebo, je bilo učinkovito pri 68 % (232 od 340) bolnikov.
Why is Parsabiv approved?
Zakaj je bilo zdravilo Parsabiv odobreno?
In the first two studies, Parsabiv was effective in 75% (380 out of 509) of patients compared with 9% (46 out of 514) of patients given placebo.
V prvih dveh študijah je bilo zdravilo Parsabiv v primerjavi z 9 % (46 od 514) bolnikov, ki so prejemali placebo, učinkovito pri 75 % (380 od 509) bolnikov.
High levels of parathyroid hormone can cause loss of calcium from the bones, bone pain and fractures, and heart and circulation problems.
Zaradi visokih vrednosti paratiroidnega hormona lahko pride do izgube kalcija iz kosti, bolečin v kosteh in zlomov kosti ter do težav s srcem in krvnim obtokom.
The active substance in Parsabiv, etelcalcetide, is a calcimimetic.
Zdravilna učinkovina v zdravilu Parsabiv, etelkalcetid, je kalcimimetik.
Parsabiv is available as a solution for injection.
Zdravilo Parsabiv je na voljo v obliki raztopine za injiciranje.
Parsabiv has been investigated in three main studies involving 1,706 patients on haemodialysis who had long-term kidney disease and secondary hyperparathyroidism.
Zdravilo Parsabiv je bilo proučeno v treh glavnih študijah, v katere je bilo vključenih 1706 bolnikov z dolgotrajno ledvično boleznijo in sekundarnim hiperparatiroidizmom, ki so prejemali hemodializo.
The first two studies compared Parsabiv with placebo (a dummy treatment), and the third study compared it with cinacalcet, another calcimimetic medicine.
V prvih dveh študijah je bilo zdravilo Parsabiv primerjano s placebom (zdravilom brez zdravilne učinkovine), v tretji pa s cinakalcetom, še enim kalcimimetičnim zdravilom.
Parsabiv is a medicine used to reduce the levels of parathyroid hormone in adults who have high levels of this hormone because of their long-term kidney disease (secondary hyperparathyroidism).
Parsabiv je zdravilo za zniževanje ravni paratiroidnega hormona pri odraslih, pri katerih je zaradi dolgotrajne ledvične bolezni raven tega hormona visoka (sekundarni hiperparatiroidizem).
For the full list of Parsabiv's side effects and restrictions, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Parsabiv glejte navodilo za uporabo.
The medicine has been found effective for reducing parathyroid hormone in the blood in patients with kidney disease being treated with haemodialysis and its side effects are those expected of a calcimimetic substance.
Zdravilo se je izkazalo za učinkovito pri zniževanju ravni paratiroidnega hormona v krvi pri bolnikih z ledvično boleznijo, ki so zdravljeni s hemodializo, njegovi neželeni učinki pa so pričakovani za kalcimimetično snov.
This means that it mimics the action of calcium on these cells and in this way, it reduces the parathyroid hormone levels in the blood.
To pomeni, da posnema učinek kalcija na te celice in tako zmanjšuje raven paratiroidnega hormona v krvi.
Parsabiv is used in patients on haemodialysis (a technique for removing waste products from the blood using a blood filtration machine).
Zdravilo Parsabiv se uporablja pri bolnikih, ki prejemajo hemodializo (postopek, pri katerem se z napravo za filtriranje krvi odstranijo odpadni produkti iz krvi).
When cells in the parathyroid gland detect high levels of calcium in the blood, they reduce the amount of parathyroid hormone entering the blood.
Ko celice v obščitnici zaznajo visoko raven kalcija v krvi, znižajo količino paratiroidnega hormona, ki vstopa v kri.
Reduced parathyroid hormone decreases the levels of calcium in the blood.
Zaradi manjše količine paratiroidnega hormona se zniža raven kalcija v krvi.
How is Parsabiv used?
Kako se zdravilo Parsabiv uporablja?
How does Parsabiv work?
Kako zdravilo Parsabiv deluje?
Parsabiv must not be started if the patient's blood calcium level is below the normal range.
Če je raven kalcija v bolnikovi krvi pod spodnjo mejo normalne vrednosti, zdravljenja z zdravilom Parsabiv ni dovoljeno začeti.
Parathyroid hormone is produced by the parathyroid glands in the neck and regulates calcium and phosphate levels.
Paratiroidni hormon, ki uravnava raven kalcija in fosfata, proizvajajo obščitnice v vratu.
Parsabiv can only be obtained with a prescription.
Predpisovanje in izdaja zdravila je le na recept.
The other concerns remained.
Drugi pomisleki so ostali nespremenjeni.
London, 19 March 2008 Doc.
London, 19. marca 2008 Sklic dok.
Ref. EMEA/CHMP/145497/2008
EMEA/224475/2008
In addition, the Committee was concerned that the company had not demonstrated that it would have been able to monitor the quality of the medicine to an acceptable level.
Nadalje je Odbor izrazil skrb, da družba ni dokazala, da bi bila zmožna nadzirati kakovost zdravila na sprejemljivi ravni.
This decreases the rate at which the substance is removed from the body and allows the medicine to be given less often.
To zmanjšuje hitrost izločanja snovi iz telesa in omogoča manj pogosto dajanje zdravila.
In addition, the study of maintenance treatment did not last long enough to give meaningful information on the medicine's long-term effects.
Nadalje študija vzdrževalnega zdravljenja ni trajala dovolj dolgo, da bi lahko nudila merodajne informacije o dolgoročnih učinkih zdravila.
The main measure of effectiveness was the proportion of patients whose symptoms had improved or disappeared after six and 26 weeks.
Glavno merilo učinkovitosti je bil delež bolnikov, katerih simptomi so se izboljšali ali izginili po šestih in 26 tednih.
In March 2008, following the re-examination, the CHMP removed its concern regarding the ability to monitor the medicine's quality.
Marca 2008, po ponovni presoji, je CHMP odpravil svoje pomisleke glede zmožnosti nadziranja kakovosti zdravila.
International non-proprietary name (INN): certolizumab pegol
Mednarodno nelastniško ime (INN): certolizumab pegol
QUESTIONS AND ANSWERS ON RECOMMENDATION FOR THE REFUSAL OF THE MARKETING AUTHORISATION for CIMZIA
VPRAŠANJA IN ODGOVORI V ZVEZI S PRIPOROČILOM ZA ZAVRNITEV VLOGE ZA DOVOLJENJE ZA PROMET z zdravilom CIMZIA
After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the recommendation for the refusal of the marketing authorisation on 19 March 2008.
Po preučitvi podlage za to zahtevo je CHMP ponovno pregledal prvotno mnenje in dne 19.marca 2008 potrdil zavrnitev vloge za dovoljenje za promet.
It also removed its concern over the possible increased risk of bleeding, but maintained a general concern over CIMZIA's safety.
Prav tako je odpravil pomislek glede morebiti povečanega tveganja za krvavitve, vendar pa je vztrajal pri splošni zaskrbljenosti glede varnosti zdravila CIMZIA.
The effects of CIMZIA were first tested in experimental models before being studied in humans.
Učinki zdravila CIMZIA so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
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 zasnovano tako, da prepozna in se veže na specifično strukturo (imenovano antigen), ki se nahaja v telesu.
The main measure of effectiveness was the proportion of the patients who were still responding to treatment after 26 weeks.
Glavno merilo učinkovitosti je bil delež bolnikov, ki so se po 26 tednih še vedno odzivali na zdravljenje.
It was to be used in patients who had not responded to a full and adequate course of therapy with a corticosteroid or an immunosuppressant medicine (a medicine that reduces the activity of the immune system) or who cannot take these therapies.
Uporabljalo bi se naj pri bolnikih, ki se niso odzvali na celotno in ustrezno zdravljenje s kortikosteroidom ali imunosupresivom (zdravilom, ki zmanjša aktivnost imunskega sistema), ali pri bolnikih, pri katerih tovrstno zdravljenje ni mogoče.
The Committee was also concerned over CIMZIA's safety: although generally comparable with the safety of other medicines in the same class, there was also some concern over a possible increased risk of bleeding in patients receiving CIMZIA.
Odbor je imel tudi pomisleke o varnosti zdravila CIMZIA: čeprav je bila varnost v splošnem primerljiva z varnostjo drugih zdravil istega razreda, so se pojavili tudi nekateri pomisleki glede morebitnega povečanega tveganja za krvavitve pri bolnikih, prejemajočih zdravilo CIMZIA.
In the study of induction treatment, CIMZIA showed only marginal effectiveness, which was too low to be relevant for patients.
V študiji indukcijskega zdravljenja je zdravilo CIMZIA izkazalo le majhno učinkovitost, ki je bila prenizka, da bi lahko bila pomembna za bolnike.
The first study looked at the reduction of symptoms during ‘induction treatment' in 660 patients who had not received CIMZIA before.
Prva študija je preučevala zmanjšanje simptomov med „indukcijskim zdravljenjem“ pri 660 bolnikih, ki predhodno niso prejemali zdravila CIMZIA.
In November 2007, the CHMP was concerned that there was insufficient evidence to show a benefit of CIMZIA.
Novembra 2007 je bil CHMP mnenja, da ni zadostnih dokazov, ki bi izkazovali koristi zdravila CIMZIA.
The company that applied for authorisation is UCB Pharma SA.
Vlogo za dovoljenje za promet z zdravilom je podala družba UCB Pharma SA.
What is CIMZIA?
Kaj je zdravilo CIMZIA?
The second study looked at the maintenance of the medicine's effects in 428 patients who had responded to an initial six-week course of CIMZIA.
Druga študija je preučevala vzdrževanje učinkov zdravila pri 428 bolnikih, ki so se odzvali na začetno šesttedensko zdravljenje z zdravilom CIMZIA.
On 15 November 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product CIMZIA 200 mg powder and solvent for solution for injection, intended for the treatment of severe, active Crohn's disease.
Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 15. novembra 2007 priporočil zavrnitev vloge za dovoljenje za promet z zdravilom CIMZIA, 200 mg, praškom in vehiklom za pripravo raztopine za infundiranje, namenjenim za zdravljenje hude, aktivne Crohnove bolezni.
The effectiveness of adding CIMZIA to existing treatment was compared with that of placebo (a dummy treatment) in two main studies involving adults with moderate to severe Crohn's disease.
Učinkovitost dodajanja zdravila CIMZIA k obstoječemu zdravljenju so primerjali z učinkovitostjo dodajanja placeba v dveh glavnih študijah, ki sta vključevali odrasle z zmerno do hudo Crohnovo boleznijo.
This messenger is involved in causing inflammation and is found at high levels in patients with active Crohn's disease.
Ta prenašalec sodeluje pri nastanku vnetja in ga pri bolnikih z aktivno Crohnovo boleznijo najdemo v visokih koncentracijah.
What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using CIMZIA?
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila CIMZIA?
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with CIMZIA.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila CIMZIA.
Therefore, at that point in time, the CHMP was of the opinion that the benefits of CIMZIA in the treatment of severe, active Crohn's disease did not outweigh its risks.
Posledično je CHMP tedaj menil, da koristi zdravila CIMZIA pri zdravljenju hude, aktivne Crohnove bolezni ne odtehtajo z njim povezanih tveganj.
CIMZIA was expected to be used to treat severe, active Crohn's disease (a disease causing inflammation of the digestive tract).
Zdravilo CIMZIA bi se naj uporabljalo za zdravljenje hude, aktivne Crohnove bolezni (bolezni, ki povzroča vnetje prebavnega trakta).
It includes certolizumab, which is part of a monoclonal antibody.
Vključuje certolizumab, ki je del monoklonskega protitelesa.