natgillin/translations-raw huggingface dataset:
Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml of solvent, both closed with a butyl elastomer closure and sealed with an aluminium cap. 
Prebodna steklenička iz stekla tipa 1, ki vsebuje 1 odmerek liofilizata, in prebodna steklenička iz stekla tipa I, ki vsebuje vehikel; obe zaprti z gumijastim zamaškom in zaščiteni z aluminijasto zaporko.
This vaccine should not be handled by persons who are immunodeficient or taking immunosuppressive medicinal products. 
Oseba, ki daje zdravilo živalim, ne sme imeti oslabljenega imunskega sistema ali uživati zdravila, ki slabijo imunski sistem.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administrated with Merial non-adjuvanted vaccine against feline leukaemia 
Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša in daje z Merialovim neadjuviranim cepivom proti levkemiji mačk.
PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. 
FARMACEVTSKA OBLIKA Liofilizat in vehikel za suspenzijo za injiciranje.
ROUTE(S) OF ADMINISTRATION Subcutaneous use 
POT(I) UPORABE ZDRAVILA Subkutana uporaba
Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus and Chlamydophila felis. 
Vzpodbuja aktivno imunost proti herpesvirusu kužnega rinotraheitisa, kalicivirusu in Chlamydophila felis.
EXPIRY DATE EXP (mm/yyyy) 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP (mesec/leto)
2: egg infective dose 50% 
2: 50% infektivni odmerek za embrionirana kokošja jajca
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies. 
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno mešati z Merialovim neadjuviranim cepivom proti levkemiji mačk in/ali dati isti dan, vendar ne zmešano z Merialovim cepivom proti steklini.
Lyophilisate and solvent for suspension for injection. 
Liofilizat in vehikel za suspenzijo za injiciranje
Manufacturer for the batch release: MERIAL 
Izdelovalec, odgovoren za sprostitev serije MERIAL
Inject by subcutaneous route one dose (1ml) of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination scheme: 
Po rekonstituciji liofilizirane sestavine z vehiklom injicirajte odmerek (1-ml) cepiva v podkožje, po naslednjem razporedu:
Inject by subcutaneous route one dose (1 ml) of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination scheme: 
Po rekonstituciji liofilizirane sestavine z vehiklom injicirajte 1 ml odmerek (1 ml) cepiva v podkožje, po naslednjem razporedu:
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE 
POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE
Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml) 
Liofilizat (10 stekleničk z 1 odmerkom) in vehikel (10 stekleničk po 1 ml) Liofilizat (50 stekleničk z 1 odmerkom) in vehikel (50 stekleničk po 1 ml)
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products 
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi Odpadne snovi odstranite s prekuhavanjem, sežigom ali potopitvijo v ustreznem dezinfekcijskem sredstvu, katerega uporabo odobrijo pristojni organi.
CONTRAINDICATIONS Do not use in pregnant animals. 
KONTRAINDIKACIJE Ne uporabite v obdobju brejosti.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administrated with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies. 
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno mešati z Merialovim neadjuviranim cepivom proti levkemiji mačk in/ali dati isti dan, vendar ne zmešano z
Vaccine against feline viral rhinotracheitis, feline calicivirosis and chlamydiosis. 
Cepivo proti virusnemu rinotraheitisu, kalicivirusu in klamidiozi.
Pack containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent Pack containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent 
Vsebnik z10 stekleničkami z 1 odmerkom liofilizata in 10 stekleničkami po 1 ml vehikla Vsebnik s 50 stekleničkami z 1 odmerkom liofilizata in 50 stekleničkami po 1 ml vehikla
NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCCh lyophilisate and solvent for suspension for injection 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Purevax RCCh liofilizat in vehikel za suspenzijo za injiciranje
NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCCh 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Purevax RCCh
Marketing authorisation holder: MERIAL 
Imetnik dovoljenja za promet z zdravilom MERIAL
D. STATEMENT OF THE MRLs Not applicable 
D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL)
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Pack of 10 bottles of lyophilisate and 10 bottles of solvent Pack of 50 bottles of lyophilisate and 50 bottles of solvent 
Vsebnik z10 stekleničkami liofilizata in 10 stekleničkami vehikla Vsebnik s 50 stekleničkami liofilizata in 50 stekleničkami vehikla
29, avenue Tony Garnier 69007 LYON FRANCE 
29 avenue Tony Garnier 69007 LYON FRANCIJA
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No effect other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days. 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), če je potrebno
NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCCh lyophilisate for injection 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Purevax RCCh liofilizat za injiciranje.
29, avenue Tony Garnier F-69007 LYON FRANCE 
29 avenue Tony Garnier F-69007 LYON FRANCIJA
Special precautions for use in animals 
Posebni previdnostni ukrepi za uporabo pri živalih Cepite le zdrave živali.
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ...................................... ≥ 104.9 CCID50 Inactivated feline Calicivirosis antigens (FCV 431 and G1 strains) .............................. ≥ 2.0 ELISA U. Attenuated Chlamydophila felis (905 strain) .................................................................... ≥ 103.0 EID50 Excipient: 
Inaktivirani antigeni kalici virusa mačk (sev FCV 431 in G1) ......................... ≥ 2,0 enot v testu ELISA
Per dose of 1ml: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50 
Atenuirani herpes virus rinotraheitisa mačk (sev FHV F2) ............................................ ≥ 104,9 CCID50
Laboratoire Porte des Alpes Rue de l'Aviation F-69800 Saint Priest France 
F-69800 Saint Priest
Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and Chlamydophila felis components. 
Imunost proti kužnemu rinotraheitisu, kalicivirusu mačk in Chlamydophila felis nastopi 1 teden po osnovnem cepljenju.
Special precautions for storage 
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA
Gentamicin, at most.......................................................................................................................... 28 µg Solvent: 
Pomožna snov: Gentamicin, največ ........................................................................................................................... 28 µg
Keep out of the reach and sight of children. 
Zaščitite pred svetlobo.
The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure. 
Veljavna različica povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo so končne različice, ki so bile sestavljene med postopkom koordinacijske skupine.
Your doctor will want to monitor you closely for at least 16 weeks. 
Zdravnik vas bo želel natančneje spremljati vsaj 16 tednov.
40 to less than 60 60 to less than 100 above 100 
40 do manj kot 60 60 do manj kot 100 več kot 100
Do not give this medicine to children under 18 years of age as no data are available on its safety and effectiveness in this group. 
Ne dajajte tega zdravila otrokom, mlajšim od 18 let, ker podatki o njegovi varnosti in učinkovitosti v tej skupini niso na voljo.
Elderly population (> 65 years old) 
Starejši (> 65 let)
In accordance with national recommendations, your doctor might consider that you need supplementary measures to prevent infection. 
V skladu z nacionalnimi priporočili utegne vaš zdravnik presoditi, da potrebujete dodatne ukrepe za preprečevanje okužbe.
The infusion will take approximately 2 hours. 
Infuzija traja približno 2 uri.
Minimum infusion duration minutes (hours) 
Najkrajše trajanje infuzije minute (ure)
Vaccination may further activate complement. 
Cepljenje lahko še bolj aktivira komplement.
Your first dose is called the loading dose. 
Vaš prvi odmerek se imenuje polnilni odmerek.
Other systemic infections 
Druge sistemske okužbe
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 July 2019 
Datum prve odobritve: 02. julij 2019
Aseptic technique must be used. 
Uporabljena naj bo aseptična tehnika.
Pack size of one vial. 
Pakiranje z eno vialo.
The effects of the medicine on an unborn child are not known. 
Učinki zdravila na nerojenega otroka niso znani.
By reporting side effects, you can help provide more information on the safety of this medicine. 
S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
A risk to infants cannot be excluded. 
Tveganja za dojenega otroka ne moremo izključiti.
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1371/001 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1371/001
The patient should be monitored for one hour following infusion. 
Bolnikovo stanje je treba spremljati eno uro po infuziji.
Ravulizumab should be given to a pregnant woman only if clearly needed. 
Ravulizumab je dovoljeno dati nosečnici samo, če je to nedvomno potrebno.
Male Female 
moški ženski
You should also be aware that vaccination may not always prevent this type of infection. 
Zavedati se morate tudi, da cepljenje ne prepreči tovrstnih okužb.
The safety and efficacy of ravulizumab in children with PNH aged 0 to < 18 years have not been established. 
Varnost in učinkovitost ravulizumaba pri otrocih s PNH, starih od 0 do < 18 let, nista bili dokazani.
You should take this into consideration if you are on a controlled sodium diet. 
To morate upoštevati, če ste na dieti z nadzorovanim vnosom natrija.
Treatment with any therapeutic protein may induce an immune response. 
Zdravljenje s katero koli terapevtsko beljakovino lahko sproži imunski odziv.
Consideration should be given to official guidance on the appropriate use of antibacterial agents. 
Upoštevati je potrebno uradne smernice za pravilno uporabo antibiotikov.
Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines. 
Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
Please refer to section 4.4 for information on prevention and treatment of suspected meningococcal infection. 
Glejte poglavje 4.4 za informacije o preprečevanju in zdravljenju domnevnih meningokoknih okužb.
The time to maximum observed concentration (tmax) is expected at the end of infusion (EOI) or soon after EOI. 
Pričakovani čas največje ugotovljene koncentracije (tmax) je ob koncu infuzije (end of infusion - EOI) ali kratek čas po EOI.
The following requirements need to be fulfilled before the product is dispensed: 
Pred izdajo zdravila morajo biti izpolnjene naslednje zahteve:
Each vial is intended for single use only. 
Ena viala je namenjena samo za enkratno uporabo.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 
Za izboljšanje sledljivosti bioloških zdravil morata biti jasno dokumentirana ime in številka serije prejetega zdravila.
All 3 recovered while continuing treatment with ravulizumab. 
Vsi trije so okrevali med nadaljevanjem zdravljenja z ravulizumabom.
Adult patients with PNH 
Odrasli bolniki s PNH
This is equivalent to 133 % of the recommended maximum daily dietary intake of sodium for an adult. 
To je enako 133 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
If you experience any of the symptoms described above, you should take the course of antibiotics as prescribed. 
Če opazite katerega izmed zgoraj opisanih simptomov, vzemite antibiotike, kot vam je bilo predpisano.
Patheon Biologics LLC 4766 La Guardia Drive St. Louis, Missouri 63134 UNITED STATES 
Patheon Biologics LLC 4766 La Guardia Drive St. Louis, Missouri 63134 ZDRUŽENE DRŽAVE
This medicine has been prescribed for you only. 
- Zdravilo je bilo predpisano vam osebno.
In case of infusion reaction, infusion of ravulizumab should be interrupted and appropriate supportive measures should be instituted if signs of cardiovascular instability or respiratory compromise occur. 
V primeru infuzijske reakcije je potrebno infuzijo ravulizumaba prekiniti in uvesti ustrezne podporne ukrepe, če nastopijo znaki kardiovaskularne nestabilnosti ali kompromitiranega dihanja.
No animal studies have been conducted to evaluate the genotoxic and carcinogenic potential of ravulizumab. 
Študij na živalih za oceno genotoksičnega in kancerogenega potenciala ravulizumaba niso izvedli.
This anti-drug antibody was transient in nature with low titre and did not correlate with clinical response or adverse events. 
To protitelo proti zdravilu je bilo po naravi prehodno z nizkim titrom in ni bilo v korelaciji s kliničnim odzivom ali neželenimi dogodki.
Patients must be vaccinated or revaccinated according to current national guidelines for vaccination use. 
Bolnike je treba cepiti ali ponovno cepiti v skladu z veljavnimi nacionalnimi smernicami za cepljenje.
There is no evidence indicating any special precautions are required for treating a geriatric population - although experience with ravulizumab in elderly patients is limited. 
Ni dokazov, ki bi kazali, da so pri zdravljenju geriatrične populacije potrebni kakšni posebni previdnostni ukrepi - čeprav je izkušenj z ravulizumabom pri starejših bolnikih malo.
The following information is intended for healthcare professionals only: Instructions for Use for Healthcare Professionals Handling Ultomiris 
Naslednje informacije so namenjene samo zdravstvenemu osebju: Navodila za uporabo za zdravstveno osebje Ravnanje z zdravilom Ultomiris
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden uporabite to zdravilo.
In pregnant women the use of ravulizumab may be considered following an assessment of the risks and benefits. 
Pri nosečnicah se uporaba ravulizumaba ocenjuje na podlagi razmerja med tveganjem in koristjo.
This medicine contains sodium (see section 2 “Ultomiris contains sodium”). 
To zdravilo vsebuje natrij (glejte poglavje 2 “Zdravilo Ultomiris vsebuje natrij”).
Adverse reactions are listed by MedDRA system organ class (SOC) and frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from available data). 
Neželeni učinki so navedeni po organskem sistemu MedDRA (system organ class - SOC) in pogostnosti z uporabo naslednjega dogovora: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
If you experience any of the meningococcal infection symptoms (see section 2 Meningococcal infection symptoms), you should immediately inform your doctor. 
Če opazite simptome meningokokne okužbe (glejte poglavje 2 Simptomi meningokokne okužbe), nemudoma obvestite svojega zdravnika.
Vaccination may not be sufficient to prevent meningococcal infection. 
Cepljenje mogoče ne bo zadostovalo za preprečitev meningokokne okužbe.
The prepared solution should be administered immediately following preparation unless it is stored at 2-8°C. 
Pripravljeno raztopino je treba uporabiti takoj po pripravi, razen če je shranjena pri 2-8 °C.
Transfer the recommended dose to an infusion bag. 
• Prenesite priporočeni odmerek v infuzijsko vrečko.
No case of overdose has been reported to date. 
Doslej niso poročali o primerih prevelikega odmerjanja.
The educational and controlled distribution programme is aimed at education and instruction of healthcare professionals/patients about the detection, careful monitoring, and/or proper management of selected safety concerns associated with Ultomiris. 
Cilj izobraževalnega programa in sistema nadzorovane distribucije je izobraževanje in poučevanje zdravstvenih delavcev/bolnikov o odkrivanju, skrbnem spremljanju in/ali primernem obvladovanju določenih varnostnih tveganj, povezanih z zdravilom Ultomiris.
Patients should be provided with information from the Package Leaflet to increase their awareness of potential serious infections and their signs and symptoms. 
Bolnike je treba seznaniti z informacijami iz navodila za uporabo zdravila, da bi povečali njihovo pozornost za možnost pojava resnih okužb ter njihovih znakov in simptomov.
Very common (may affect more than 1 in 10 people): Headache 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
Physicians should advise patients about gonorrhoea prevention. 
Zdravniki morajo bolnikom svetovati glede preprečevanja okužbe z gonorejo.
If you have any of these symptoms, contact your doctor. 
Če imate katerega od teh simptomov, se posvetujte z zdravnikom.
FUJIFILM Diosynth Biotechnologies U.S.A., Inc. 6051 George Watts Hill Drive Research Triangle Park, North Carolina 27709 UNITED STATES 
FUJIFILM Diosynth Biotechnologies U.S.A., Inc. 6051 George Watts Hill Drive Research Triangle Park, North Carolina 27709 ZDRUŽENE DRŽAVE
More than 80 % of patients in both treatment groups had a history of transfusion within 12 months of study entry. 
Več kot 80 % bolnikov v obeh zdravljenih skupinah je imelo anamnezo transfuzije v zadnjih 12 mesecih od vključitve v študijo.
Mean (SD) Median Min, max 
povprečje (SD) mediana min, maks
However, chemical and physical stability of the diluted product have been demonstrated for up to 24 hours at 2°C-8°C and up to 6 hours at room temperature. 
Vendar pa so dokazali kemijsko in fizikalno stabilnost razredčenega zdravila za največ 24 ur pri 2 °C-8 °C in za največ 6 ur pri sobni temperaturi.
Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA43 
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AA43
Ultomiris is not recommended during pregnancy and in women of childbearing potential not using contraception. 
Zdravila Ultomiris ni priporočljivo uporabljati med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
Infections Before starting Ultomiris, inform your doctor if you have any infections. 
Okužbe Preden se začnete zdraviti z zdravilom Ultomiris, obvestite zdravnika, če imate katero koli okužbo.
Ravulizumab preserves the early components of complement activation that are essential for opsonisation of microorganisms and clearance of immune complexes. 
Ravulizumab ohranja zgodnje komponente aktivacije komplementa, ki so bistvene za opsonizacijo mikroorganizmov in očistek imunskih kompleksov.
Your dose will be worked out by your doctor, based on your body weight, as shown in Table 1. 
Vaš odmerek bo določil vaš zdravnik na podlagi vaše telesne mase, kot kaže preglednica 1.
After dilution, the medicinal product should be used immediately. 
Po redčenju je treba zdravilo uporabiti takoj.
Any patient who discontinues ravulizumab should be monitored for at least 16 weeks to detect haemolysis and other reactions. 
Vsakega bolnika, ki se preneha zdraviti z ravulizumabom, je treba spremljati najmanj 16 tednov, da odkrijemo hemolizo in druge reakcije.
Dosing schedule is allowed to occasionally vary by ± 7 days of the scheduled infusion day (except for the first maintenance dose of ravulizumab) but the subsequent dose should be administered according to the original schedule. 
Shema odmerjanja sme občasno variirati za ± 7 dni od načrtovanega dne infuzije (razen pri prvem vzdrževalnem odmerku ravulizumaba), vendar je treba naslednji odmerek dati v skladu z originalno shemo.
You should bear in mind that you should still see a doctor as soon as possible, even if you feel better after having taken the antibiotics. 
Kljub temu je potrebno obiskati zdravnika, takoj ko je to mogoče, tudi v primeru boljšega počutja po jemanju antibiotikov.
The mean total PNH RBC clone size was 60.05 %, mean total PNH granulocyte clone size was 83.30 %, and the mean total PNH monocyte clone size was 85.86 %. 
Povprečna skupna velikost klona RBC PNH je bila 60,05 %, povprečna skupna velikost klona granulocitov PNH je bila 83,30 %, povprečna skupna velikost klona monocitov PNH pa je bila 85,86 %.
If the patient is being switched from eculizumab treatment, physicians should verify that meningococcal vaccination is current according to national guidelines for vaccination use. 
Če bolnik prehaja iz zdravljenja z ekulizumabom, morajo zdravniki preveriti, ali je meningokokno cepljenje glede na nacionalne smernice za uporabo cepiv veljavno.
Ultomiris should be prepared for administration by a qualified healthcare professional using aseptic technique. 
Zdravilo Ultomiris mora pripraviti za uporabo usposobljen zdravstveni delavec z uporabo aseptične tehnike.
Prior to launch of Ultomiris in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational and controlled distribution programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority. 
Pred prihodom zdravila Ultomiris na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega programa in sistema nadzorovane distribucije, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi drugimi vidiki programa.
Two weeks after receiving your loading dose, you will be given a maintenance dose of Ultomiris, and this will then be repeated once every 8 weeks. 
Dva tedna po prejemu polnilnega odmerka boste prejeli vzdrževalni odmerek zdravila Ultomiris, nato boste tak odmerek prejemali enkrat na 8 tednov.
Vaccination reduces, but does not eliminate, the risk of meningococcal infections. 
Cepljenje zmanjša, vendar pa ne odpravi tveganja za pojav meningokoknih okužb.
Note: LDH = lactate dehydrogenase; CI = Confidence Interval. 
Opomba: LDH = laktat dehidrogenaza; IZ = interval zaupanja.
The safety and efficacy of ravulizumab have not been studied in patients with hepatic impairment; however pharmacokinetic data suggest that no dose adjustment is required in patients with hepatic impairment. 
Varnosti in učinkovitosti ravulizumaba pri bolnikih z okvaro jeter niso raziskovali; vendar farmakokinetični podatki kažejo, da pri bolnikih z okvaro jeter prilagajanje odmerka ni potrebno.
Age (years) at PNH diagnosis 
Starost (leta) ob postavitvi diagnoze PNH