natgillin/translations-raw huggingface dataset:
This study is still ongoing and aims to show that Epostim has the same effect on maintaining haemoglobin levels as Eprex.
Ta študija še poteka, z njo pa želijo pokazati, da ima zdravilo Epostim enak učinek na vzdrževanje ravni hemoglobina kot zdravilo Eprex.
The epoetin alfa in Epostim is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce it.
Epoetin alfa v zdravilu Epostim se proizvaja z metodo, znano kot „tehnologija rekombinantne DNA“: tvori ga celica, ki je prejela gen (DNA), s katerim lahko tvori eritropoetin.
• to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce their need for blood transfusions;
• za zdravljenje anemije pri odraslih, ki prejemajo kemoterapijo za določene vrste raka, in zmanjševanje njihove potrebe po transfuziji krvi;
In these cases, erythropoietin is used to replace the missing hormone or to increase red blood cell counts.
V teh primerih se eritropoetin uporablja, da nadomesti manjkajoči hormon ali zviša raven rdečih krvnih celic.
• to treat anaemia (low red blood cell counts) that is causing symptoms in adults and children with ‘chronic renal failure' (long-term, progressive decrease in the ability of the kidneys to work properly);
• za zdravljenje anemije (nizko število rdečih krvnih celic), ki povzroča simptome pri odraslih in otrocih s „kronično odpovedjo ledvic“ (dolgotrajno, napredujoče upadanje sposobnosti ledvic za pravilno delovanje);
On 15 March 2011, Reliance GeneMedix Plc officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Epostim to be used to treat anaemia and stimulate red blood cell production.
Družba Reliance GeneMedix Plc je dne 15. marca 2011 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Epostim, namenjenim zdravljenju anemije in spodbujanju tvorjenja rdečih krvnih celic.
A second main study in 188 kidney patients compared Epostim with the reference medicine Eprex.
V drugi glavni študiji so pri 188 bolnikih s težami z ledvicami primerjali zdravilo Epostim z referenčnim zdravilom Eprex.
• to increase the amount of blood that can be taken from patients who are going to need the blood after surgery (autologous blood transfusion);
• za povečanje količine krvi, ki se lahko odvzame bolnikom, ki bodo potrebovali kri po operaciji (avtologna transfuzija krvi);
Withdrawal of the marketing authorisation application for Epostim (epoetin alfa)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Epostim (epoetin alfa)
In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin.
Pri bolnikih, ki prejemajo kemoterapijo, ali pri bolnikih s težavami z ledvicami lahko pomanjkanje eritropoetina ali nezadostna odzivnost telesa na eritropoetin povzroči anemijo.
Erythropoietin is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.
Eritropoetin se uporablja tudi pred operacijami za povečanje števila rdečih krvnih celic in kot pomoč pri zmanjševanju posledic izgube krvi.
Epostim is a solution for injection that contains the active substance epoetin alfa.
Zdravilo Epostim je raztopina za injiciranje, ki vsebuje zdravilno učinkovino epoetin alfa.
Epostim was developed as a ‘biosimilar' medicine.
Zdravilo Epostim je bilo razvito kot „podobno biološko“zdravilo.
In a main study in 75 adults with anaemia caused by kidney problems, patients were treated with Epostim and their blood levels of haemoglobin (a protein in red blood cells) measured to see how much their anaemia improved.
V glavni študiji je sodelovalo 75 odraslih bolnikov z anemijo zaradi težav z ledvicami, ki so jih zdravili z zdravilom Epostim in pri katerih so merili raven hemoglobina v krvi (beljakovina v rdečih krvnih celicah), da bi ugotovili, v kolikšni meri se je anemija pri njih pozdravila.
Erythropoietin is produced by the kidneys.
Eritropoetin tvorijo ledvice.
The reference medicine for Epostim is Eprex.
Referenčno zdravilo za zdravilo Epostim je zdravilo Eprex.
• to reduce the need for blood transfusions in non-iron deficient patients who are about to undergo major orthopaedic (bone) surgery.
• za zmanjšanje potrebe po transfuziji krvi pri odraslih bolnikih brez pomanjkanja železa pred večjo ortopedsko operacijo (operacijo na kosteh).
A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.
Hormon, imenovan eritropoetin, spodbuja tvorjenje rdečih krvnih celic v kostnem mozgu.
The active substance in Epostim, epoetin alfa, is a copy of human erythropoietin and was expected to work in exactly the same way as the natural hormone to stimulate red blood cell production.
Zdravilna učinkovina v zdravilu Epostim, epoetin alfa, je kopija človeškega eritropoetina in naj bi pri spodbujanju tvorjenja rdečih krvnih celic delovala povsem enako kot naravni hormon.
What is Epostim?
Kaj je zdravilo Epostim?
What was Epostim expected to be used for?
Za kaj naj bi se zdravilo Epostim uporabljalo?
How is Epostim expected to work?
Kako naj bi zdravilo Epostim delovalo?
Pharmaceutical Form Route of Administration
Farmacevtska oblika pot uporabe
Invented name Strength
Številka EU Izmišljeno ime Jakost
Packaging
Subkutano
10 vials + 10 vials
0,65 ml 10 vial + 10 vial
1 vial + 1 vial
0,65 ml 1 viala + 1 viala
10 vials + 10 pre-filled syringes with attached needle
0,65 ml 10 vial + 10 napolnjenih injekcijskih brizg z nameščenimi iglami
1 vial + 1 pre-filled syringe + 2 separate needles
0,65 ml 1 viala + 1 napolnjena injekcijska brizga +2 nepritrjeni igli
1 vial + 1 pre-filled syringe + 1 separate needle
0,65 ml 1 viala + 1 napolnjena injekcijska brizga + 1 nepritrjena igla
1 vial + 1 pre-filled syringe without needle
0,65 ml 1 viala + 1 napolnjena injekcijska brizga brez igle
1 vial + 1 pre-filled syringe with attached needle
0,65 ml 1 viala + 1 napolnjena injekcijska brizga z nameščeno iglo
06 March 2012
6. marec 2012
The European Commission issued a decision on 06 March 2012.
Evropska komisija je sklep izdala dne 6. marca 2012.
On 20 April 2011, Denmark referred the matter to the CHMP for arbitration.
Dne 20. aprila 2011 je Danska zadevo napotila na CHMP v arbitražo.
Why was Norditropin reviewed?
Zakaj je bilo zdravilo Norditropin pregledano?
The Committee looked at the study presented by the company to support the new indication.
Odbor je pregledal študijo, ki jo je družba predložila v podporo novi indikaciji.
In May 2010, the company applied for an additional indication in Denmark and in the following Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Maja 2010 je družba predložila vlogo za dodatno indikacijo na Danskem in v naslednjih državah članicah: Avstrija, Belgija, Bolgarija, Ciper, Češka republika, Estonija, Finska, Francija, Nemčija, Grčija, Madžarska, Irska, Italija, Latvija, Litva,
Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom1.
Luksemburg, Malta, Nizozemska, Poljska, Portugalska, Romunija, Slovaška, Slovenija, Španija, Švedska in Združeno kraljestvo1.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP agreed that the data were insufficient and that the study presented, which was an observational study, did not meet required methodological standards.
CHMP se je po vrednotenju trenutno razpoložljivih podatkov in znanstveni razpravi v Odboru strinjal, da so podatki nezadostni in da predložena študija, ki je bila opazovalna, ne izpolnjuje zahtevanih metodoloških standardov.
The Member States cited methodological weaknesses in the study presented, the wide range of doses used and insufficient data (e.g. missing data on body composition measurements).
Države članice so se sklicevale na metodološke pomanjkljivosti v predstavljeni študiji, širok razpon uporabljenih odmerkov in nezadostne podatke (npr. manjkajoče podatke o meritvah telesne sestave).
The company that makes the medicine is NovoNordisk.
Družba, ki izdeluje zdravilo, je NovoNordisk.
1 In May 2011 the marketing authorisations of the concerned products were withdrawn in Estonia, and in June 2011 the marketing authorisations of the concerned products were withdrawn in Latvia.
Dovoljenja za promet z zadevnimi zdravili so bila maja 2011 umaknjena v Estoniji in junija 2011 v Latviji.
Growth hormone promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fat and carbohydrates.
Rastni hormon spodbuja rast v obdobju otroštva in adolescence ter vpliva na način, kako telo presnavlja beljakovine, maščobo in ogljikove hidrate.
The European Medicines Agency has completed an arbitration procedure for Norditropin and associated names.
Evropska agencija za zdravila je zaključila arbitražni postopek za zdravilo Norditropin in povezana imena.
The CHMP therefore recommended that the new indication for Norditropin and associated names should not be granted in Denmark or in the concerned Member States.
CHMP je zato priporočil, naj se nova indikacija za zdravilo Norditropin in povezana imena na Danskem ali v zadevnih državah članicah ne odobri.
Norditropin is authorised under a mutual recognition procedure based on an initial authorisation granted by Denmark.
Zdravilo Norditropin je bilo odobreno v postopku z medsebojnim priznavanjem na podlagi prvotnega dovoljenja za promet, ki je bilo odobreno na Danskem.
Although somatropin medicines are already approved in EU Member States for use in Prader-Willi syndrome, the Member States were unable to reach agreement on whether to accept this indication for Norditropin.
Čeprav so zdravila s somatropinom v državah članicah EU že odobrena za uporabo pri zdravljenju Prader-Willijevega sindroma, se države članice niso uspele dogovoriti glede tega, ali naj sprejmejo to indikacijo za zdravilo Norditropin.
What is Norditropin?
Kaj je zdravilo Norditropin?
The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on a requested change to the marketing authorisation for these medicines to include a new indication for use in children with Prader-Willi syndrome.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je bil pozvan, naj sprejme odločitev o zahtevani spremembi dovoljenja za promet za ta zdravila, ki se nanaša na vključitev nove indikacije za uporabo pri otrocih s Prader-Willijevim sindromom.
It is also used to correct short height in girls who have the genetic disease called Turner syndrome, in children who have long-standing kidney problems, and in children born small for their gestational age and who have not caught up by the age of four.
Uporablja se tudi za uravnavanje nizke rasti pri deklicah z genetsko boleznijo, imenovano Turnerjev sindrom, pri otrocih, ki imajo dolgotrajne težave z ledvicami, ter otrocih, ki so se rodili majhni za svojo gestacijsko starost in do četrtega leta niso nadomestili zaostanka.
The new indication was for the use of Norditropin in children with Prader-Willi syndrome, a rare genetic disease that affects children's growth and development.
Nova indikacija je zajemala uporabo zdravila Norditropin pri otrocih s Prader-Willijevim sindromom, redko genetsko boleznijo, ki vpliva na rast otrok in njihov razvoj.
Norditropin is a medicine that contains somatropin, which is a copy of naturally occurring human growth hormone.
Norditropin je zdravilo, ki vsebuje somatropin, kopijo naravnega humanega rastnega hormona.
The grounds for the referral were the concerns of some Member States that the data on Norditropin submitted in the application were not sufficient to demonstrate its effectiveness in Prader-Willi syndrome.
Podlaga za napotitev so bili pomisleki nekaterih držav članic, da podatki o zdravilu Norditropin, predloženi v vlogi, niso zadostni, da bi dokazovali njegovo učinkovitost pri zdravljenju Prader-Willijevega sindroma.
Norditropin is used as replacement therapy in children and adults who have a growth hormone deficiency.
Zdravilo Norditropin se uporablja kot nadomestna terapija pri zdravljenju otrok in odraslih s pomanjkanjem rastnega hormona.
The somatropin in Norditropin is produced by a method known as ‘recombinant DNA technology': it is made by an organism that has received a gene (DNA), which makes the organism able to produce it. Norditropin is marketed in the EU Member States under the names Norditropin FlexPro, Norditropin NordiFlex, Norditropin SimpleXx and associated names.
Zdravilo Norditropin se v državah članicah EU trži pod imeni Norditropin FlexPro, Norditropin NordiFlex, Norditropin SimpleXx in povezanimi imeni.
The Reference Member State (RMS) for the decentralised procedure for Pantoprazole Olinka application was UK and the Concerned Member States (CMS) were: Germany and Poland.
Referenčna država članica decentraliziranega postopka za uporabo zdravila Pantoprazole Olinka je bila Združeno kraljestvo, zadevne države članice pa so bile Češka republika, Nemčija, Poljska in Slovaška.
Other concerns LoOI-Q1: The Applicant was requested to clarify the origin and name of the reference product used in the new bioequivalence study.
Drugi zadržki s seznama izrazitih zadržkov - V1: Predlagatelj je bil pozvan, naj pojasni izvor in ime referenčnega zdravila, uporabljenega v novi bioekvivalenčni študiji.
It is only used in patients who have responded well to their current HIV treatment and who do not have an HIV infection that is resistant to treatment or not likely to respond to any of the active substances in the medicine.
Uporablja se le pri bolnikih, ki so se dobro odzvali na dosedanje zdravljenje okužbe z virusom HIV in ki niso okuženi z virusom HIV, odpornim proti zdravljenju ali verjetno neodzivnim na katero koli od zdravilnih učinkovin v zdravilu.
It does not cure HIV infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa podaljša čas do nastopa poškodb imunskega sistema in razvoja okužb in bolezni, povezanih z aidsom.
The company that markets the medicine will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with medicines containing tenofovir disoproxil such as this one.
Družba, ki trži zdravilo, bo zagotovila, da bodo vsi zdravniki, ki naj bi predpisovali zdravilo, prejeli izobraževalno gradivo, ki bo vsebovalo informacije o povečanem tveganju ledvične bolezni pri zdravilih, ki vsebujejo dizoproksiltenofovirat, kot ga tudi to zdravilo.
The company also carried out a study that showed that the medicine is ‘bioequivalent' to the reference medicine.
Opravila je tudi študijo, ki je pokazala, da je zdravilo biološko enakovredno referenčnemu zdravilu.
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is an antiviral medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan je protivirusno zdravilo, ki se uporablja za zdravljenje odraslih, okuženih z virusom humane imunske pomanjkljivosti-1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Atripla, and do not need to be repeated for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih uporabah so že bile izvedene z referenčnim zdravilom Atripla, zato jih ni treba ponoviti za zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan.
Because Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan keeps the amount of HIV in the blood at a low level.
Zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan ohranja nizko raven virusa HIV v krvi.
For practical information about using Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
This is a summary of the European public assessment report (EPAR) for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan.
This medicine should not be taken at the same time as other medicines that contain efavirenz, emtricitabine or tenofovir disoproxil, or lamivudine (another antiviral medicine).
To zdravilo se ne sme jemati sočasno z drugimi zdravili, ki vsebujejo efavirenz, emtricitabin, dizoproksiltenofovirat ali lamivudin (drugo protivirusno zdravilo).
What is Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan and what is it used for?
Kaj je zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan in za kaj se uporablja?
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan efavirenz / emtricitabine / tenofovir disoproxil
Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan efavirenz/emtricitabin/dizoproksiltenofovirat
Other information about Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
Druge informacije o zdravilu Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan
Inactivated poliomyelitis virus (IPV): type 1
Inaktivirane polioviruse (IPV): tipa 1
Recombinant hepatitis B surface antigen, S (HBsAg)
Površinski antigen virusa hepatitisa B (HbsAg)
EU Number Invented name Strength Pharmaceutical formRoute of administration Packaging
Zaščiteno ime Jakost Farmacevtska oblika Pot uporabe Ovojnina
1 Monodose preparation of 0.5 ml contains: Purified diptheria toxoid, adsorbed (PDT)
Posamezni odmerek 0,5 ml vsebuje: Prečiščen davični toksoid, adsorbiran (PDT)
Purified tetanus toxoid, adsorbed (PTT)
Prečiščen tetanusni toksoid, adsorbiran (PTT)
Purified pertussis toxoid, adsorbed (PTxd)
Prečiščen toksoid bordetele pertusis, adsorbiran (PTxd)
Purified filamentous haemagglutinin adsorbed (FHA)
Prečiščen filamentozni hemaglutinin bordetele pertusis,adsorbiran (FHA)
1 syringe with attached needle
1 injekcijska brizga s priloženo iglo
10 syringes without attached needle with 1 separate needle
10 injekcijskih brizg brez pritrjeneigle z 1 ločeno iglo
1 syringe without attached needle with 1 separate needle
1 injekcijska brizga brez pritrjene igle z 1 ločeno iglo
10 syringes without attached needle with 2 separate needles
10 injekcijskih brizg brez pritrjeneigle z 2 priloženima iglama
1 syringe without attached needle with 2 separate needles
1 injekcijska brizga brez pritrjene igle z 2 priloženima iglama
Haemophilus influenzae polysaccharide type b conjugated to tetanus protein (PRP-T)
Polisaharid Haemophilus influenzae tipa B
1 syringe without attached needle
1 injekcijska brizga brez priložene igle
The European Commission granted a marketing authorisation valid throughout the European Union for Ruconest on 28 October 2010.
Evropska komisija je dovoljenje za promet z zdravilom Ruconest, veljavno po vsej Evropski uniji, izdala 28. oktobra 2010.
Patients may be able to inject the medicine themselves after they have been properly trained.
Bolniki si lahko zdravilo injicirajo sami, potem ko so bili za to ustrezno usposobljeni.
What measures are being taken to ensure the safe and effective use of Ruconest?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ruconest?
One injection is usually enough to treat an attack, but a second injection may be given if the patient does not improve enough after the first one.
Ena injekcija navadno zadošča za zdravljenje napada, vendar se lahko vbrizga drugi odmerek, če se bolnikovo stanje po prvi injekciji ne izboljša dovolj.
Improvement was measured by the patients rating the severity of their symptoms on a scale from 0 to 100.
Izboljšanje so merili bolniki, ki so ocenjevali resnost simptomov na lestvici od 0 do 100.
It is given by slow injection into a vein lasting around five minutes.
Zdravilo se daje s počasnim injiciranjem v veno, ki traja približno pet minut.
The main measure of effectiveness was how long it took for the symptoms to start to improve.
Glavno merilo učinkovitosti je bil čas do začetka izboljšanja simptomov.
A patient should not be given more than two injections within any 24-hour period.
Bolnik v 24-urnem obdobju ne sme prejeti več kot dve injekciji.
Patients with angioedema have attacks of swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain.
Bolniki z angioedemom imajo napade otekanja, ki se lahko pojavijo kjer koli v telesu, na primer na obrazu, okončinah ali okoli črevesja, in povzročajo nelagodje in bolečino.
Patients receiving placebo started to improve after four hours in one study and after over eight hours in the other.
Pri bolnikih, ki so prejeli placebo, je bilo v eni študiji opaziti izboljšanje po štirih urah, v drugi študiji pa po več kot osmih urah.
In this case the powder that comes with the solvent should be used.
V tem primeru je treba uporabiti prašek s priloženim vehiklom.
The most common side effect with Ruconest (seen in between 1 and 10 patients in 100) is headache.
Najpogostejši neželeni učinek zdravila Ruconest (opažen pri 1 do 10 bolnikih od 100) je glavobol.
Other information about Ruconest
Druge informacije o zdravilu Ruconest
The full EPAR for Ruconest can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ruconest je na voljo na spletni strani agencije EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Patients receiving Ruconest at doses of 50 units/kg and 100 units/kg started to improve after one and two hours.
Pri bolnikih, ki so prejeli zdravilo Ruconest v odmerku 50 enot/kg in 100 enot/kg, je bilo opaziti izboljšanje po eni ali dveh urah.
What benefits of Ruconest have been shown in studies?
Kakšne koristi je zdravilo Ruconest izkazalo v študijah?
For more information about treatment with Ruconest, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Ruconest preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ruconest have also 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 Ruconest upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
What is Ruconest and what is it used for?
Kaj je zdravilo Ruconest in za kaj se uporablja?
Why is Ruconest approved?
Zakaj je bilo zdravilo Ruconest odobreno?
Ruconest must not be used in patients with known or suspected allergy to rabbits.
Zdravilo Ruconest se ne sme uporabljati pri bolnikih z znano ali domnevno alergijo na zajce.
This is a summary of the European public assessment report (EPAR) for Ruconest.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ruconest.
What is the risk associated with Ruconest?
Kakšna tveganja so povezana z zdravilom Ruconest?