natgillin/translations-raw huggingface dataset:
If you notice sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, fast heart beat, dizziness, light headedness, shortness of breath, wheezing or trouble breathing or flu-like symptoms, tell your doctor or nurse immediately.
Če opazite nenadne znake alergije, na primer izpuščaj, srbenje ali koprivnico na koži, otekanje obraza, ustnic, jezika ali drugih delov telesa, hiter srčni utrip, vrtoglavost, omotičnost, kratko sapo, sopenje ali oteženo dihanje ali podobne simptome kot pri gripi, o tem nemudoma obvestite svojega zdravnika ali medicinsko sestro.
In adults, the most commonly reported side effects were constipation, nausea, diarrhoea, weight increase, headache, pain, swelling of hands, ankles or feet, high blood pressure, anaemia, changes in blood chemistry (e. g. potassium, cholesterol, phosphate, creatinine), surgical wound complications, and various kinds of infections.
Pri odraslih so najpogosteje poročani neželeni učinki zapeka, slabost s siljenjem na bruhanje (navzea), driska, povečanje telesne teže, glavobol, bolečine, otekanje dlani, gležnjev ali stopal, zvišan krvni tlak, slabokrvnost, spremembe biokemijskih izvidov krvi (na primer kalija, holesterola, fosfatov, kreatinina), zapleti kirurške rane in različne vrste okužb.
What Simulect contains
Kaj vsebuje zdravilo Simulect
- The active substance is basiliximab.
- Zdravilna učinkovina je baziliksimab.
- The other ingredients are: potassium dihydrogen phosphate; disodium phosphate, anhydrous;
- Pomožne snovi so: kalijev dihidrogenfosfat; natrijev hidrogenfosfat, brezvodni; natrijev klorid;
What Simulect looks like and contents of the pack Simulect comes as a white powder in a colourless glass vial containing 20 mg of basiliximab.
Izgled zdravila Simulect in vsebina pakiranja Simulect je na voljo v obliki praška v prozorni stekleni viali, ki vsebuje 20 mg baziliksimaba.
33 Manufacturer Novartis Pharma S. A. S.
Izdelovalec Novartis Pharma S. A. S.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
33 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
35 INSTRUCTIONS FOR RECONSTITUTION AND ADMINISTRATION
35 NAVODILA ZA PRIPRAVO IN UPORABO
After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C or for 4 hours at room temperature.
24 ur pri temperaturi 2 °C - 8 °C ali 4 ure pri sobni temperaturi.
For infusion, the reconstituted solution should be diluted to a volume of 50 ml or greater with normal saline or dextrose 50 mg/ ml (5%).
Za infuzijo je treba pripravljeno raztopino razredčiti do skupnega volumna 50 ml ali več s fiziološko raztopino ali z raztopino glukoze 50 mg/ ml (5- odstotne).
The first dose should be given within 2 hours before transplantation surgery, and the second dose 4 days after transplantation.
Prvi odmerek damo 2 uri ali manj pred začetkom presaditvene operacije, drugega pa 4 dni po presaditvi.
Since no data are available on the compatibility of Simulect with other intravenous substances, Simulect should not be mixed with other medications/ substances and should always be given through a separate infusion line.
Ker ni podatkov o združljivosti Simulecta z drugimi zdravili za intravensko uporabo, Simulecta ne smemo mešati z drugimi zdravili in ga moramo vedno dajati po ločenem infuzijskem kanalu.
Infusion bag
Infuzijska vrečka
Simulect 10 mg powder and solvent for solution for injection or infusion Basiliximab
Simulect 10 mg prašek in vehikel za raztopino za injiciranje ali infundiranje baziliksimab
- if you have previously been in the operating theatre for a transplantation that in the end was not
- če ste bili kdaj prej že v operacijski dvorani zaradi presaditve, ki na koncu ni bila opravljena.
37 Using other medicines Please tell your doctor, nurse or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
37 Uporaba drugih zdravil Obvestite svojega zdravnika, medicinsko sestro ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Simulect is given twice, in hospital, either slowly through a needle in your vein as an infusion lasting 20– 30 minutes or as an intravenous injection using a syringe.
Simulect boste v bolnišnici dobili samo ob presaditvi nove ledvice, in sicer dvakrat, skozi iglo v veno bodisi v obliki infuzije, trajajoče 20– 30 minut, ali naenkrat v obliki intravenske injekcije z brizgalko.
What Simulect looks like and contents of the pack Simulect comes as a white powder in a colourless glass vial containing 10 mg of basiliximab.
Izgled zdravila Simulect in vsebina pakiranja Simulect je na voljo v obliki praška v prozorni stekleni viali, ki vsebuje 10 mg baziliksimaba.
2.5 ml of the sterile water is used to dissolve the powder before it is given to you.
2, 5 ml sterilne vode se uporabi, da se pred uporabo raztopi prašek.
39 Manufacturer Novartis Pharma S. A. S.
39 Izdelovalec Novartis Pharma S. A. S.
41 INSTRUCTIONS FOR RECONSTITUTION AND ADMINISTRATION
41 NAVODILO ZA PRIPRAVO IN UPORABO
To prepare the solution for infusion or injection, take 2.5 ml water for injections out of the accompanying 5 ml ampoule aseptically and add this 2.5 ml water for injections to the vial containing the Simulect powder, using aseptic technique.
Raztopino za infuzijo pripravimo tako, da aseptično odvzamemo 2, 5 ml vode za injekcije iz priložene 5- mililitrske ampule in aseptično dodamo ta 2, 5 ml vode za injekcije v vialo s Simulectom v prahu.
For infusion, the reconstituted solution should be diluted to a volume of 25 ml or greater with normal saline or dextrose 50 mg/ ml (5%).
Za infuzijo je treba pripravljeno raztopino razredčiti do skupnega volumna 25 ml ali več s fiziološko raztopino ali z raztopino glukoze 50 mg/ ml (5- odstotne).
Since no data are available on the compatibility of Simulect with other intravenous substances, Simulect should not be mixed with other medications/ substances and should always be given through a separate infusion line.
Ker ni podatkov o združljivosti Simulecta z drugimi zdravili za intravensko uporabo, Simulecta ne smemo mešati z drugimi zdravili/ snovmi in ga moramo vedno dajati po ločenem infuzijskem kanalu.
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED TO THE MEMBER STATES
1 POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO UPOŠTEVATI DRŽAVE ČLANICE
The EU Member States shall ensure that:
Države članice EU zagotovijo naslednje:
The MAH shall agree the details of a distribution system with the National Competent Authorities and must implement such programme nationally to ensure that:
Imetnik dovoljenja za promet z zdravilom mora s pristojnimi nacionalnimi organi uskladiti podrobnosti distribucijskega sistema ter na nacionalni ravni izvesti tak program, da bo zagotovil, da:
• drug distribution will only be possible after checking that the patient has effectively received a meningococcal vaccination with a written confirmation • prior to distribution, all health care professionals are provided with information on the following key safety concerns: o Headache o Infusion reaction o Neisseria and general infection o Risk of serious haemolysis following eculizumab discontinuation and proposed management o Pregnancy and need of adequate contraception in women of childbearing potential o Immunogenicity o Renal and hepatic impairment.
bo predpisovanje zdravila možno le po preverjanju, da je bolnik dejansko prejel • meningokokno cepljenje s pisnim potrdilom, so pred predpisovanjem zdravila vsi zdravstveni delavci obveščeni o naslednjih ključnih • varnostnih vidikih: glavobol o reakcija na infuzijo o Neisseria in splošna okužba o tveganje za resno hemolizo po prekinitvi jemanja ekulizumaba in predlagana terapija o nosečnost in potreba po ustrezni kontracepciji pri ženskah v rodni dobi o imunogenost o okvara ledvic in jeter. o
Prior to launch, the MAH shall agree on the implementation of a patient card system in each Member Sate.
Imetnik dovoljenja za promet z zdravilom mora pred pričetkom trženja v vsaki državi članici uskladiti izvedbo sistema bolnikove kartice.
This patient card will provide details of the signs and symptoms of infection as well as instruction for the patient to immediately seek medical care.
Ta bolnikova kartica bo podajala podrobnosti o znakih in simptomih okužbe ter navodilo za bolnika, naj nemudoma poišče zdravniško pomoč.
The card will also provide information to health care professionals that the patient is receiving Soliris treatment.
Kartica bo tudi nudila informacijo zdravstvenemu osebju, da bolnik prejema zdravljenje z zdravilom Soliris.
The MAH shall propose a detailed methodology for the Health Care Professionals and Patient survey.
Imetnik dovoljenja za promet z zdravilom bo predlagal podrobno metodologijo za raziskavo med zdravstvenim osebjem in bolniki.
In addition to the assessment of the satisfaction of eculizumab information provided, the proposed questionnaire will investigate other methods for assessing the effectiveness of the risk minimisation program (e. g. surveys to follow compliance to vaccination).
Poleg ocene zadovoljstva s ponujenimi informacijami o ekulizumabu bo predlagani vprašalnik raziskal tudi druge metode za ocenjevanje učinkovitosti programa minimalizacije tveganj (npr. raziskave za spremljanje izvajanja cepljenja).
The evaluation of the goals for distribution of educational materials should also be considered.
Upoštevati je treba tudi vrednotenje ciljev glede distribucije izobraževalnih gradiv.
Soliris is a concentrate that is made up into a solution for infusion.
Zdravilo Soliris je koncentrat za pripravo raztopine za infudiranje.
Soliris is used to treat patients with paroxysmal nocturnal haemoglobinuria (PNH), a rare, life- threatening genetic disease that causes the red blood cells to be broken down too quickly.
Zdravilo Soliris se uporablja za zdravljenje bolnikov s paroksizmalno nočno hemoglobinurijo (PNH), redko, smrtno nevarno prirojeno boleznijo, ki povzroča prehitro razgradnjo rdečih krvničk.
This results in anaemia (low red blood cell counts), thrombosis (formation of blood clots in the blood vessels) and dark urine.
Posledica tega je slabokrvnost (nizko število rdečih krvničk), tromboza (tvorjenje krvnih strdkov v ožilju) in temen urin.
Because the number of patients with PNH is low, the disease is considered ‘ rare’, and Soliris was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 17 October 2003.
Ker je število bolnikov s PNH majhno, velja ta bolezen za redko, zato je bilo zdravilo Soliris 17. oktobra 2003 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja pri redkih boleznih).
Soliris should be given by a healthcare professional, such as a doctor or nurse, under the supervision of a doctor who has experience in the management of patients with blood disorders.
Zdravilo Soliris mora dajati zdravstveni delavec, kot je denimo zdravnik ali medicinska sestra, in sicer pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov s krvnimi motnjami.
Treatment with Soliris consists of an intravenous infusion (drip into a vein) of 600 mg over 25 to 45 minutes once a week, followed by 900 mg in the fifth week.
Zdravljenje z zdravilom Soliris se izvaja v obliki intravenskega infundiranja (kapalne infuzije v veno) 600 mg odmerka v trajanju 25 do 45 minut enkrat tedensko, čemur sledi infundiranje 900 mg odmerka v petem tednu.
Thereafter, the dose should be maintained at 900 mg, given approximately every two weeks.
V nadaljevanju je treba vzdrževati odmerek 900 mg, ki se daje približno enkrat na dva tedna.
At least two weeks before starting Soliris treatment, patients must be vaccinated against meningitis caused by the bacterium Neisseria meningitidis and revaccinated according to current guidelines.
Bolnike je treba najmanj dva tedna pred začetkom zdravljenja z zdravilom Soliris cepiti proti meningitisu, ki ga povzroča bakterija Neisseria meningitidis, in jih ponovno cepiti v skladu z veljavnimi smernicami.
Soliris has not been studied in children or in patients who have problems with their kidneys or liver.
Zdravilo Soliris ni bilo raziskano na otrocih ali bolnikih, ki imajo težave z ledvicami ali jetri.
Patients who receive Soliris must be given a special card that explains the symptoms of certain types of infection, instructing them to seek medical care immediately if they experience them.
Bolniki, ki prejemajo zdravilo Soliris, morajo dobiti posebno kartico, ki vsebuje razlago simptomov določenih vrst okužb in navodilo za bolnike, naj ob pojavu teh simptomov nemudoma poiščejo medicinsko pomoč.
The active substance in Soliris, eculizumab, is a monoclonal antibody.
Zdravilna učinkovina zdravila Soliris je monoklonsko protitelo ekulizumab.
In PNH, patients have a defect in a protein (called CD59) on the surface of their red blood cells that normally stops complement from attacking the cells.
Ekulizumab je zasnovan tako, da se veže na beljakovino komplementa C5, ki je del obrambnega sistema telesa, imenovan „ komplement “.
(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 red blood cells.
Posledica te napake je, da komplement začne uničevati rdeče krvničke.
By blocking the C5 complement protein, eculizumab prevents complement from attacking the cells, reducing their destruction and improving the symptoms of the disease.
Ekulizumab z blokiranjem beljakovine komplementa C5 preprečuje, da bi komplement napadel celice, zmanjšuje njihovo uničenje in izboljšuje simptome bolezni.
The effects of Soliris were first tested in experimental models before being studied in humans.
Učinki zdravila Soliris so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Soliris has been studied in one main study involving 88 adult patients with PNH who had had at least four blood transfusions for anaemia in the previous year.
Zdravilo Soliris so preučevali v eni glavni študiji z 88 odraslimi bolniki s PNH, ki so imeli v preteklem letu zaradi slabokrvnosti najmanj štiri transfuzije krvi.
The effects of Soliris were compared with those of placebo (a dummy treatment).
Učinke zdravila Soliris so primerjali z učinki placeba (zdravila brez zdravilne učinkovine).
The main measures of effectiveness were the proportion of patients whose levels of haemoglobin (a protein found in red blood cells) remained above their individual target level, and the number of red blood cell transfusions that the patients needed during the first 26 weeks of treatment.
Glavni merili učinkovitosti sta bili delež bolnikov, pri katerih so ravni hemoglobina (beljakovine, ki se nahaja v rdečih krvničkah) ostale nad njihovo individualno ciljno ravnjo, in število transfuzij rdečih krvničk, ki so jih bolniki potrebovali v prvih 26 tednih zdravljenja.
What benefit has Soliris shown during the studies?
Kakšne koristi je zdravilo Soliris izkazalo med raziskavami?
Soliris was more effective than placebo in improving the symptoms of PNH.
Zdravilo Soliris je bilo pri izboljšanju simptomov PNH učinkovitejše od placeba.
In the main study, 21 (49%) of the 43 patients receiving Soliris had stable haemoglobin levels, and, on average, they did not need any transfusions of red blood cells.
V glavni študiji je imelo 21 (49%) od 43 bolnikov, ki so prejemali zdravilo Soliris, stabilne ravni hemoglobina in v povprečju tudi niso potrebovali transfuzij rdečih krvničk.
In comparison, none of the 44 patients receiving placebo had stable haemoglobin levels, and they needed an average of 10 transfusions.
V primerjavi s tem ni imel noben od 44 bolnikov, ki so prejemali placebo, stabilnih ravni hemoglobina, potrebovali pa so tudi povprečno 10 transfuzij.
The most common side effects with Soliris (seen in more than 1 patient in 10) are urinary tract infection (infection of the structures that carry urine), nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infection (colds), dizziness, headache, diarrhoea, nausea (feeling sick), back pain, arthralgia (joint pain), pyrexia (fever) and contusion (bruising).
Najpogostejši neželeni učinki zdravila Soliris (opaženi pri več kot 1 bolniku izmed 10) so okužba sečil (okužba struktur za odvajanje urina), nazofaringitis (vnetje nosu in žrela), okužba zgornjih dihal (prehladi), omotica, glavobol, driska, navzeja (slabost), bolečine v hrbtu, artralgija (bolečine v sklepih), pireksija (vročina) in kontuzija (podplutba).
For the full list of all side effects reported with Soliris, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Soliris, glejte Navodilo za uporabo.
Because of an increased risk of meningitis, Soliris should not be given to people who are infected with Neisseria meningitidis, or who have not been vaccinated against this bacterium.
Zdravila Soliris se zaradi povečanega tveganja za meningitis ne sme dajati osebam, ki so okužene z bakterijo Neisseria meningitidis ali niso bile cepljene proti tej bakteriji.
It should not be used in people who may be hypersensitive (allergic) to eculizumab, mouse proteins or any of the other ingredients, or who have, or are thought to have, inherited deficiencies in complement.
Ne sme se ga uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) ekulizumab, mišje beljakovine ali katerokoli drugo sestavino zdravila oziroma ki imajo ali bi utegnile imeti podedovane pomanjkljivosti komplementa.
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Soliris are greater than its risks for the treatment of patients with PNH, but noted that evidence of the benefit of Soliris is limited to patients who have had blood transfusions in the past.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Soliris pri zdravljenju bolnikov s PNH večje od z njim povezanih tveganj, vendar je opozoril, da so dokazi o koristih zdravila Soliris omejeni zgolj na bolnike, ki so v preteklosti imeli transfuzije krvi.
The Committee recommended that Soliris be given marketing authorisation.
Odbor je zato priporočil odobritev dovoljenja za promet za zdravilo Soliris.
Which measures are being taken to ensure the safe use of Soliris?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Soliris?
The company that makes Soliris will agree the details of a system in each Member State that will ensure that distribution of the medicine only occurs after checking that the patient has been vaccinated appropriately.
Podjetje, ki izdeluje zdravilo Soliris, bo določilo podrobnosti sistema v posamezni državi članici, ki bo zagotavljal, da se distribucija zdravila izvede šele po preverjanju, ali je bil bolnik ustrezno cepljen.
It will also provide prescribers with information on the safety of the medicine.
Zdravnikom, ki predpisujejo zdravila, bo podjetje priskrbelo tudi informacije o varnosti zdravila.
Other information about Soliris:
Druge informacije o zdravilu Soliris:
The European Commission granted a marketing authorisation valid throughout the European Union for Soliris to Alexion Europe SAS on 20 June 2007.
Evropska komisija je dovoljenje za promet z zdravilom Soliris, veljavno po vsej Evropski uniji, odobrila družbi Alexion Europe SAS dne 20. junija 2007.
The summary of opinion of the Committee for Orphan Medicinal Products for Soliris is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Soliris je na voljo tukaj.
The full EPAR for Soliris can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Soliris je na voljo tukaj.
This summary was last updated in 05-2007.
Povzetek je bil nazadnje posodobljen 05- 2007.
Content (concentration)
vsebina
Package size
velikost
EU/ 1/ 07/ 393/ 001
(koncentracija) pakiranja EU/ 1/ 07/ 393/ 001
30 ml (10 mg/ ml)
30 ml (10 mg/ ml) 1 viala
Each vial of 30 ml contains 300 mg of eculizumab (10 mg/ ml).
Ena 30 ml viala vsebuje 300 mg ekulizumaba (10 mg/ ml).
Eculizumab is a humanised monoclonal IgG2/ 4κ antibody produced in NS0 cell line by recombinant DNA technology.
Ekulizumab je humanizirano monoklonsko protitelo IgG2/ 4κ, pridobljeno s tehnologijo rekombinantne DNA iz celične linije NS0.
After dilution, the final concentration of the solution to be infused is 5mg/ ml.
Po razredčenju je končna koncentracija raztopine, pripravljene za infundiranje, enaka 5 mg/ ml.
Excipients:
Pomožne snovi: natrij (5, 00 mmol na odmerek (1 viala))
Sodium (5.00 mmol per dose (1 vial))
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Concentrate for Solution for Infusion.
Koncentrat za pripravo raztopine za infundiranje.
Clear, colorless, pH 7.0 solution.
Bistra, brezbarvna raztopina s pH 7, 0.
Soliris (eculizumab) is indicated for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH).
Zdravilo Soliris (ekulizumab) je indicirano za zdravljenje bolnikov s paroksizmalno nočno hemoglobinurijo (PNH).
Evidence of clinical benefit of Soliris in the treatment of patients with PNH is limited to patients with history of transfusions.
Dokazi o klinični koristi zdravila Soliris pri zdravljenju bolnikov s PNH so omejeni na bolnike s transfuzijsko anamnezo.
To reduce the risk of meningococcal infection (Neisseria meningitidis), all patients must be vaccinated at least 2 weeks prior to receiving Soliris and must be re-vaccinated according to current medical guidelines for vaccination use (see section 4.4).
4. 2 Odmerjanje in način uporabe
Soliris should be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with haematological disorders.
Zdravilo Soliris mora dajati zdravstveni delavec, in sicer pod nadzorom zdravnika z izkušnjami z zdravljenjem bolnikov s hematološkimi motnjami.
The dosing regimen consists of a 5-week initial phase followed by a maintenance phase:
Režim odmerjanja je sestavljen iz 5- tedenske začetne faze, ki ji sledi faza vzdrževanja:
Initial phase:
začetna faza:
600 mg of eculizumab via a 25 - 45 minute intravenous infusion every week for the first 4 weeks, followed by 900 mg of eculizumab for the fifth week of the initial phase.
600 mg ekulizumaba v obliki 25 – 45- minutne intravenske infuzije enkrat na teden prve 4 tedne, čemur sledi 900 mg ekulizumaba v petem tednu začetne faze;
Maintenance phase:
faza vzdrževanja:
900 mg of Soliris administered via a 25 - 45 minute intravenous infusion every 14 ± 2 days (see Section 5.1).
900 mg zdravila Soliris v obliki 25 – 45- minutne intravenske infuzije vsakih 14 ± 2 dni (glejte poglavje 5. 1).
Instructions for preparation of the diluted solutions are described in section 6.6.
Navodila za pripravo razredčenih raztopin so opisana v poglavju 6. 6.
2 Do not administer as an intravenous push or bolus injection.
2 Zdravila ni dovoljeno dajati v obliki hitre intravenske ali bolusne injekcije.
The diluted solution of Soliris should be administered by intravenous infusion over 25 – 45 minutes via gravity feed, a syringe-type pump, or an infusion pump.
Razredčena raztopina ekulizumaba se daje v obliki 25 – 45- minutne intravenske infuzije s pomočjo kapalnega sistema, brizgalne črpalke ali infuzijske črpalke.
If the infusion is slowed, the total infusion time may not exceed two hours.
Če se infuzija upočasni, skupni čas infuzije ne sme presegati dveh ur.
There is no experience in children (see section 5.2) Elderly:
Izkušenj z uporabo pri otrocih ni (glejte poglavje 5. 2).
The safety and efficacy of Soliris have not been studied in patients with renal impairment.
Varnost in učinkovitost zdravila Soliris pri bolnikih z okvaro ledvic ni bila preučena.
Hypersensitivity to eculizumab, murine proteins or to any of the excipients.
Preobčutljivost za ekulizumab, mišje beljakovine ali katerokoli pomožno snov.
Do not initiate Soliris therapy in patients:
Ne uvajajte zdravljenja z zdravilom Soliris pri bolnikih: