natgillin/translations-raw huggingface dataset:
In TRIUMPH, study patients treated with Soliris had significantly reduced (p < 0.001) haemolysis resulting in improvements in anaemia as indicated by increased haemoglobin stabilization and reduced need for RBC transfusions compared to placebo treated patients (see table 3).
V študiji TRIUMPH so imeli sodelujoči bolniki, zdravljeni z zdravilom Soliris pomembno zmanjšano (p < 0, 001) hemolizo, kar je privedlo do izboljšanja slabokrvnosti, kakor to kaže večja stabilizacija hemoglobina in zmanjšanje potrebe po transfuziji eritrocitov v primerjavi z bolniki, zdravljenimi s placebom (glejte tabelo 3).
These effects were seen among patients within each of the three pre-study RBC transfusion strata (4 - 14 units; 15 - 25 units; > 25 units).
Ti učinki so bili opaženi pri bolnikih iz vseh treh stratumov, opredeljenih glede na število transfuzij eritrocitov pred študijo (4 - 14 enot; 15 - 25 enot; > 25 enot).
After 3 weeks of Soliris treatment, patients reported less fatigue and improved health- related quality of life.
Po 3 tednih zdravljenja z zdravilom Soliris so bolniki poročali o manjši utrujenosti in izboljšanju z zdravjem povezane kakovosti življenja.
A reduction in intravascular haemolysis as measured by serum LDH levels was sustained for the treatment period and resulted in increased transfusion avoidance, a reduced need for RBC transfusion and less fatigue.
Doseženo je bilo vzdrževano zmanjšanje intravaskularne hemolize, merjene z ravnjo LDH v serumu, v času zdravljenja, kar je privedlo do povečane nepotrebnosti transfuzije, zmanjšanja potrebe po transfuziji eritrocitov in zmanjšanja utrujenosti.
See Table 3.
Glejte tabelo 3.
Efficacy Outcomes in C04-001 and C04-002
Rezultati učinkovitosti v študijah C04- 001 in C04- 002
Soliris
Odstotek
Percentage of patients with
bolnikov
P
vrednost
– Value
stabiliziranimi
stabilized Hemoglobin levels at end of study PRBC transfused during
ravnmi
treatment (median) Transfusion Avoidance during
hemoglobina ob koncu študije Koncentrirani eritrociti, prejeti s transfuzijo med zdravljenjem (mediana)
<
0 0
treatment (%) LDH levels at end of study
Nepotrebnost transfuzije
(median, U/L) LDH AUC at end of study
8 Ravni LDH ob koncu študije (mediana, e. / l) LDH AUC ob koncu študije
(median, U/L x Day) Free Hemoglobin at end of study
(mediana, e. / l x dan) Prosti hemoglobin ob koncu
411,822
411. 822
58,587
58. 587
-632,264
- 632. 264
(median, mg/dL)
študije (mediana, mg/ dl) Utrujenost po FACIT (velikost
FACIT-Fatigue (effect size)
učinka)
* Results from study C04-002 refer to pre- versus post-treatment comparisons.
* Rezultati za študijo C04- 002 se nanašajo na primerjavo stanja pred zdravljenjem napram stanju po zdravljenju.
8 From the 195 patients that originated in C04-001, C04-002 and other initial studies, Soliris-treated PNH patients were enrolled in a long term extension study (E05-001).
Od 195 bolnikov iz študij C04- 001 in C04- 002 ter drugih izhodiščnih študij so bili tisti bolniki s PNH, ki so bili zdravljeni z zdravilom Soliris, vključeni v dolgoročno razširitveno študijo (E05- 001).
All patients sustained a reduction in intravascular haemolysis over a total Soliris exposure time ranging from 10 to 54 months.
Pri vseh bolnikih je bilo ohranjeno zmanjšanje intravaskularne hemolize v celotnem obdobju izpostavljenosti zdravilu Soliris, trajajočemu od 10 do 54 mesecev.
There were fewer thrombotic events with Soliris treatment than during the same period of time prior to treatment.
Pri zdravljenju z zdravilom Soliris je prišlo do manjšega števila trombotičnih zapletov kot v enako dolgem obdobju pred zdravljenjem.
Pharmacokinetics and Drug Metabolism:
Farmakokinetika in presnova zdravila:
No specific studies have been performed to evaluate the hepatic, renal, lung, or gastrointestinal routes of excretion/elimination for Soliris.
Izvedena ni bila nobena specifična študija, s katero bi ocenili poti izločanja zdravila Soliris preko jeter, ledvic, pljuč ali prebavil.
Pharmacokinetic Parameters:
Farmakokinetični parametri:
Mean clearance was 0.31 ± 0.12 ml/hr/kg, mean volume of distribution was 110.3 ± 17.9 ml/kg, and mean elimination half-live was 11.3 ± 3.4 days.
Povprečni očistek je bil 0, 31 ± 0, 12 ml/ h/ kg, povprečni volumen porazdelitve 110, 3 ± 17, 9 ml/ kg in razpolovni čas izločanja 11, 3 ± 3, 4 dni.
Based on these data, the onset of steady state is predicted to be approximately 49 – 56 days..
Na podlagi teh podatkov je predviden čas do nastopa stanja dinamičnega ravnovesja približno 49 – 56 dni.
Pharmacodynamic activity correlates directly with eculizumab serum concentrations and maintenance of trough levels above ≥ 35 microgram/ml results in essentially complete blockade of haemolytic activity in the majority of patients.
Med farmakodinamično aktivnostjo in koncentracijami ekulizumaba v serumu obstaja neposredna korelacija; vzdrževanje minimalne koncentracije nad ≥ 35 mikrogramov/ ml pri večini bolnikov povzroči dejansko popolno zaustavitev hemolize.
Formal studies have not been conducted to evaluate the pharmacokinetics of Soliris administration in special patient populations based on gender, race, age (paediatric or geriatric), or renal or hepatic impairment.
Formalne študije za oceno farmakokinetike zdravila Soliris pri posebnih skupinah bolnikov na podlagi spola, rase, starosti (pediatrične ali geriatrične) ali okvare ledvic ali jeter niso bile izvedene.
C5 expression in the human tissue panel examined in this study is consistent with published reports of C5 expression, as C5 has been reported in smooth muscle, striated muscle, and renal proximal tubular epithelium.
Izražanje C5 na panelu človeških tkiv, ki je bilo preučevano v tej študiji, je v skladu z objavljenimi poročili o izražanju C5, saj so o C5 poročali v gladkih mišicah, prečno progastih
No unexpected tissue cross-reactivity was observed.
9 mišicah in ledvičnem proksimalnem tubulnem epiteliju.
In a 26 week toxicity study performed in mice with a surrogate antibody directed against murine C5, treatment did not affect any of the toxicity parameters examined.
V 26- tedenski toksikološki študiji na miših z nadomestnim protitelesom, usmerjenim proti mišjemu C5, zdravljenje ni imelo vpliva na preučevane toksikološke parametre.
When maternal exposure to the antibody occurred during organogenesis, two cases of retinal dysplasia and one case of umbilical hernia were observed among 230 offspring born to mothers exposed to the higher antibody dose (approximately 4 times the
Pri maternalni izpostavitvi protitelesom v času organogeneze so opazili dva primera displazije retine in en primer umbilikalne hernije med 230 potomci, rojenimi materam, izpostavljenim večjim odmerkom protiteles (enakim približno štirikratniku največjega priporočenega odmerka zdravila Soliris za ljudi z ozirom na primerjavo telesne mase), vendar pa izpostavitev ni povečala izgube ploda ali neonatalne smrtnosti.
Sodium phosphate monobasic Sodium phosphate dibasic Sodium chloride Polysorbate 80 Water for injections
natrijev dihidrogenfosfat natrijev hidrogenfosfat natrijev klorid polisorbat 80 voda za injekcije
After dilution, the medicinal product should be used immediately.
Po razredčenju je treba zdravilo takoj uporabiti.
However, chemical and physical stability has been demonstrated for 24 hours at 2 – 8 °C.
Vendar pa je bila dokazana kemična in fizikalna stabilnost za čas 24 ur pri temperaturi med 2 in 8 °C.
Store in a refrigerator (2°C - 8º C) Do not freeze.
Shranjujte v hladilniku (2 °C – 8 ºC) Ne zamrzujte.
30 ml of concentrate in a vial (Type I glass) with a stopper (butyl, siliconised), and a seal (aluminium) with flip-off cap (polypropylene),.
30 ml koncentrata v viali (steklo tipa I) z zamaškom (iz silikonizirane butilne gume) in obročkom (iz aluminija) s pokrovčkom tipa » flip- off « (iz polipropilena).
Soliris should be administered by a health care professional.
Zdravilo Soliris mora dajati zdravstveni delavec.
Soliris therapy must not be initiated without prior vaccination against Neisseria meningitidis at least 2 weeks prior to initial administration.
Vsem
All patients should be administered a meningococcal vaccine at least two weeks prior to the first dose of Soliris (see section 4.4).
10 bolnikom je treba dati meningokokno cepivo najmanj dva tedna pred prvim odmerkom zdravila Soliris (glejte poglavje 4. 4).
10 Transfer the recommended dose to an infusion bag.
Priporočeni odmerek prenesite v infuzijsko vrečko.
Dilute Soliris to a final concentration of 5 mg/ml by addition to the infusion bag using 0.9% sodium chloride, 0.45% sodium chloride, or 5% Dextrose in water, as the diluent.
Zdravilo Soliris razredčite do končne koncentracije 5 mg/ ml z dodajanjem 0, 9% raztopine natrijevega klorida, 0, 45% raztopine natrijevega klorida ali 5% raztopine dekstroze v vodi kot vehikla za redčenje v infuzijsko vrečko.
The final volume of a 5 mg/ml diluted solution is 120 ml for 600 mg doses or 180 ml for 900 mg doses.
Končni volumen 5 mg/ ml razredčene raztopine je 120 ml za 600 mg odmerke ali 180 ml za 900 mg odmerke.
Alexion Europe SAS 54-56 avenue Hoche 75008 Paris FRANCE
Alexion Europe SAS 54- 56 avenue Hoche 75008 Pariz FRANCIJA
20 June 2007
20 Junij 2007
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
< Podrobne informacije o tem zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu >
101 International Drive Pease International Tradeport Portsmouth, New Hampshire 03801 U.S.A.
101 International Drive Pease International Tradeport Portsmouth, New Hampshire 03801 ZDA
228 Bath Road Slough Berkshire SL1 4DX United Kingdom
228 Bath Road Slough Berkshire SL1 4DX Velika Britanija
352 Knotter Drive Cheshire, Connecticut 06410 U.S.A.
352 Knotter Drive Cheshire, Connecticut 06410 ZDA
Almac Pharma Services 22 Seagoe Industrial Estate Craigavon BT63 5QD United Kingdom
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• 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:
bo predpisovanje zdravila možno le po preverjanju, da je bolnik dejansko prejel cepljenje • proti meningokokom 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
13
13 o imunogenost o okvara ledvic in jeter.
Prior to launch, the MAH shall agree on the implementation of a patient card system in each Member State.
Pred pričetkom trženja bo imetnik dovoljenja za promet z zdravilom v vsaki državi članici uskladil izvedbo sistema bolnikove kartice.
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 Marketing Authorisation Holder must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti obstoj in delovanje sistema farmakovigilance pred pričetkom trženja izdelka, in sicer za tako dolgo, dokler se izdelek uporablja na tržišču.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Imetnik dovoljenja za promet z zdravilom se zavezuje k izvajanju študij in dodatnih farmakovigilančnih aktivnosti, kot so podrobno navedene v farmakovigilančnem načrtu.
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management Systems for medicinal products for human use.
Predložiti je treba posodobljeni načrt za obvladovanje tveganj v skladu s smernico CHMP o sistemih za ob
15 A.LABELLING
OZNAČEVANJE
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING Carton Label
16 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Oznaka na škatli
NAME OF THE MEDICINAL PRODUCT Soliris 300 mg concentrate for solution for infusion Eculizumab
Soliris 300 mg koncentrat za pripravo raztopine za infundiranje ekulizumab
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 30 ml contains 300 mg of eculizumab (10mg/ml)
Ena 30 ml viala vsebuje 300 mg ekulizumaba (10mg/ ml)
Eculizumab is a humanised monoclonal IgG2/4 k antibody produced in NS0 cell line by recombinant DNA technology.
Ekulizumab je humanizirano monoklonsko protitelo IgG2/ 4k, pridobljeno s tehnologijo rekombinantne DNA iz celične linije NS0.
After dilution, the final concentration of the solution to be infused is 5 mg/ml.
Po razredčenju je končna koncentracija raztopine, pripravljene za infundiranje, enaka 5 mg/ ml.
LIST OF EXCIPIENTS Sodium as chloride, phosphate dibasic, phosphate monobasic, polysorbate 80 and water for injections.
Natrij v obliki klorida, hidrogenfosfat, dihidrogenfosfat, polisorbat 80 in voda za injekcije.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 x 30 ml (10 mg/ml)
koncentrat za pripravo raztopine za infundiranje 1 x 30 ml (10 mg/ ml)
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use.
POSTOPEK IN POT( I) UPORABE ZDRAVILA
Must be diluted before use.
Za intravensko uporabo.
Read the package leaflet before use.
Pred uporabo je treba izdelek razredčiti.
OTHER SPECIAL WARNING(S), IF NECESSARY
Zdravilo shranjujte nedosegljivo otrokom!
After dilution, the medicinal product should be used immediately within 24 hours.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C – 8°C).
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Do not Freeze.
Uporabno do:
Store in the original package in order to protect from light.
Po razredčenju je treba zdravilo uporabiti takoj v roku 24 ur.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Any unused product or waste material should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Alexion Europe SAS 54-56 Avenue Hoche 75008 PARIS France
Alexion Europe SAS 54- 56 avenue Hoche 75008 Pariz Francija
MARKETING AUTHORISATION NUMBER(S) EU/1/07/393/001
ŠTEVILKA( E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
BATCH NUMBER LOT:
ŠTEVILKA SERIJE
18 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
18 PODATKI, KI OVOJNINAH
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Soliris 300 mg concentrate for solution for infusion Eculizumab For intravenous use
Soliris 300 mg koncentrat za pripravo raztopine za infundiranje Ekulizumab Za intravensko uporabo
METHOD OF ADMINISTRATION To be diluted before use.
Pred uporabo zdravilo razredčite.
EXPIRY DATE EXP:
Uporabno do:
20 PACKAGE LEAFLET:
20 NAVODILO ZA UPORABO:
Soliris 300 mg, concentrate for solution for infusion Eculizumab
Soliris 300 mg, koncentrat za pripravo raztopine za infundiranje Ekulizumab
Read all of this leaflet carefully before you start using this medicine.
Pred uporabo tega zdravila natančno preberite navodilo!
- If you have any further questions, ask your doctor or pharmacist
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v
What Soliris is and what it is used for 2.
Kaj je zdravilo Soliris in za kaj ga uporabljamo 2.
Before you use Soliris 3.
Kaj morate vedeti, preden boste uporabili zdravilo Soliris 3.
How to use Soliris 4.
Kako uporabljati zdravilo Soliris 4.
How to store Soliris 6.
Shranjevanje zdravila Soliris 6.
WHAT SOLIRIS IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO SOLIRIS IN ZA KAJ GA UPORABLJAMO
The active substance of Soliris is eculizumab and it belongs to a class of medicines called monoclonal antibodies.
Učinkovina zdravila Soliris je ekulizumab, ki spada v razred zdravil, imenovan monoklonska protitelesa.
Eculizumab binds to and inhibits a specific protein in the body that causes inflammation.
Ekulizumab se veže na in zavira specifično beljakovino v telesu, ki povzroča vnetje.
Soliris is used for the treatment of patients with a certain type of disease affecting the blood system called Paroxysmal Nocturnal Haemoglobinuria (PNH).
Zdravilo Soliris se uporablja za zdravljenje bolnikov z določeno vrsto bolezni, ki prizadene krvni sistem, imenovano paroksizmalna nočna hemoglobinurija (PNH).
Eculizumab can block the body’s inflammatory response, and its ability to attack and destroy its own vulnerable PNH blood cells.
Ekulizumab lahko blokira vnetni odziv telesa in njegovo zmožnost, da napade in uniči svoje lastne občutljive krvne celice PNH.
There is only experience in the treatment of patients with previous history of transfusions.
Obstajajo izključno izkušnje z zdravljenjem bolnikov, ki so v preteklosti prejeli transfuzije.
BEFORE YOU USE SOLIRIS
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO SOLIRIS
Do not use Soliris
Ne uporabljajte zdravila Soliris,
- if you are allergic (hypersensitive) to eculizumab, proteins derived from mouse products, have
- če ste alergični na (preobčutljivi za) ekulizumab, beljakovine, pridobljene iz mišjih produktov,
(See Section 6, What Soliris contains).
ste imeli alergijsko reakcijo na druga monoklonska protitelesa ali katero drugo sestavino zdravila Soliris (glejte poglavje 6 Kaj vsebuje zdravilo Soliris);
- If you have not been vaccinated against meningitis infection.
- če niste bili cepljeni proti okužbi z meningitisom;
- If you have a meningitis infection.
- če ste okuženi z meningitisom;
- If you have a disease that alters your immune system.
- če imate bolezen, ki vpliva na vaš imunski sistem.
Take special care with Soliris
Bodite posebno pozorni pri uporabi zdravila Soliris
Meningitis alert:
Opozorilo v zvezi z meningitisom:
Soliris treatment may reduce your natural resistance to infections, especially against certain organisms that cause meningitis.
Zdravljenje z zdravilom Soliris lahko zmanjša vašo naravno odpornost na okužbe, še posebno proti določenim organizmom, ki povzročajo meningitis.
Consult your doctor before you take Soliris to be sure that you receive vaccination against Neisseria meningitidis, an organism that causes meningitis, at least 2 weeks before beginning therapy, or that your current meningitis vaccination is up to date.
Pred jemanjem zdravila Soliris se posvetujte z zdravnikom, da bi tako najmanj dva tedna pred začetkom zdravljenja zanesljivo prejeli cepivo proti Neisseria meningitidis, t. j. organizmu, ki povzroča meningitis, oziroma da vam potrdi, da je vaše cepljenje proti meningitisu še učinkovito.
You should also be aware that vaccination may not
Vendar pa se
21 prevent this type of infection.
21 morate zavedati dejstva, da cepljenje morda ne bo preprečilo tovrstne okužbe.
Meningitis symptoms Because of the importance of rapidly identifying and treating certain types of infection in patients who receive Soliris, you will be provided a card to carry with you, listing specific trigger symptoms.
Simptomi meningitisa Zaradi pomembnosti hitre identifikacije in zdravljenja določenih vrst okužb pri bolnikih, ki prejemajo zdravilo Soliris, boste prejeli kartico, ki jo boste nosili s seboj in na kateri bodo navedeni specifični simptomi, ki jih zdravilo lahko sproži.
This card is named: “Patient Safety Card”..
„ Bolnikova varnostna kartica “.
- bothersome headache with nausea or vomiting
- moteč glavobol s slabostjo ali bruhanjem;
- bothersome headache with a stiff neck or back
- moteč glavobol z otrdelim vratom ali hrbtom;
- fever
- vročina;
- fever and a rash
- vročina in izpuščaji;
- confusion
- zmedenost;
- severe muscle aches combined with flu-like symptoms
- hude bolečine v mišicah v kombinaciji z gripi podobnimi simptomi;
- sensitivity to light
- občutljivost na svetlobo.
Treatment for meningitis while travelling If you are travelling in a remote region where you are unable to contact your doctor or in which you find yourself temporarily unable to receive medical treatment, your doctor can make arrangements to issue, as a preventive measure, a prescription for an antibiotic to counter Neisseria meningitidis that you keep with you.
Zdravljenje meningitisa med potovanjem Če potujete na odročno območje, kjer se ne boste mogli posvetovati s svojim zdravnikom ali kjer začasno ne boste imeli možnosti zdravljenja, vam lahko vaš zdravnik kot preventivni ukrep izda recept za antibiotik proti meningokoku Neisseria meningitidis, ki ga imejte ves čas pri sebi.
If you experience any of the symptoms amongst those cited above, you should take a tablet of antibiotic.
Če se pri vas pojavi kateri od zgoraj navedenih simptomov, vzemite antibiotik v obliki tablete.
You should bear in mind that you should see a doctor as soon as possible, even if you feel better after having taken the antibiotic tablets.
Vendar pojdite čimprej k zdravniku, tudi če se po zaužitju antibiotika v obliki tablet počutite bolje.
Infections Inform your doctor before you take Soliris if you have any infections.
Okužbe Pred pričetkom jemanja zdravila Soliris povejte svojemu zdravniku, če imate katerokoli okužbo.
Allergic reactions Soliris contains a protein and proteins can cause allergic reactions in some people.
Alergijske reakcije Zdravilo Soliris vsebuje beljakovino, beljakovine pa lahko pri nekaterih ljudeh povzročijo alergijske reakcije.
Using Soliris with other medicines:
Uporaba zdravila Soliris z drugimi zdravili:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali druga zdravila, tudi če ste jih dobili brez recepta.
Using Soliris with food and drink:
Uporaba zdravila Soliris s hrano in pijačo:
Interactions between your treatment with Soliris and food or drink are unlikely.
Interakcije med vašim zdravljenjem z zdravilom Soliris ter hrano ali pijačo niso verjetne.
Woman of childbearing potential:
Ženske v rodni dobi:
Women who are able to get pregnant should use adequate contraception methods during treatment and up to 5 months after treatment.
Ženske, ki lahko zanosijo, morajo med zdravljenjem in do 5 mesecev po zdravljenju uporabljati ustrezne kontracepcijske metode.
Ask your doctor or pharmacist for advice before using any medicine.
Pred jemanjem kateregakoli zdravila se posvetujte z zdravnikom ali s farmacevtom.
Pregnancy Tell your doctor before starting treatment with Soliris if you are pregnant or plan to become pregnant..
Nosečnost Pred začetkom zdravljenja z zdravilom Soliris obvestite zdravnika o tem, ali ste noseči oziroma ali nameravate zanositi.
Breast-feeding Soliris may pass through your breast milk to your baby.
Dojenje Zdravilo Soliris lahko z materinim mlekom dobi vaš dojenček.
22 The effects on the ability to drive and to use machines have not been studied.
22 Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
As with all medicines, you should ask for advice from your doctor.
Kot pri vseh zdravilih, se posvetujte s svojim zdravnikom.
Elderly people There is no evidence to suggest that any special precautions are needed when older people (65 years and over) are treated – although experience is still limited.
Starejše osebe Ni dokazov, da bi bili pri zdravljenju starejših ljudi (starih 65 let in več) potrebni posebni previdnostni ukrepi – čeprav so izkušnje v zvezi s tem še vedno omejene.