FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH provided data on the above-mentioned observational studies with regards to the risk of inhibitor development in PUPs receiving FVIII products, including KOGENATE Bayer/Helixate NexGen.
Slovenian: Imetnik dovoljenj za promet z zdraviloma je predložil podatke o zgoraj omenjenih opazovalnih študijah, ki so se nanašali na tveganje za nastanek zaviralcev pri predhodno nezdravljenih bolnikih, ki so prejemali zdravila, ki vsebujejo faktor VIII, vključno z zdraviloma Kogenate Bayer in Helixate NexGen.
English: The PRAC considered results from the publication of the RODIN/PedNet study, the preliminary findings from the European Haemophilia Safety Surveillance System (EUHASS) registry and all available data submitted from clinical trials, observational studies, published literature as well as quality data for Kogenate Bayer and Helixate NexGen with regards to its potential risk of inhibitor development in previously untreated patients (PUPs) and minimally treated patients (MTPs).
Slovenian: PRAC je preučil rezultate iz objavljene študije RODIN/PedNet, predhodne ugotovitve iz registra evropskega sistema za spremljanje varnosti zdravil za hemofilijo (EUHASS) in vse razpoložljive predložene podatke iz kliničnih preskušanj, opazovalnih študij in objavljene literature ter podatke o kakovosti zdravil Kogenate Bayer in Helixate NexGen, povezane z možnim tveganjem za nastanek zaviralcev pri predhodno nezdravljenih bolnikih in minimalno zdravljenih bolnikih.
English: Kogenate Bayer and Helixate NexGen are full-length recombinant human antihaemophilic factor VIII (octocog alfa) produced in baby hamster kidney (BHK) cells.
Slovenian: Zdravili Kogenate Bayer in Helixate NexGen vsebujeta humani rekombinantni koagulacijski faktor VIII (oktokog alfa) celotne dolžine, ki nastaja v ledvičnih celicah mladičev hrčkov.
English: The efficacy of Kogenate Bayer/Helixate NexGen is recognised and the PRAC reviewed the data related to inhibitor development in PUPs and MTPs.
Slovenian: Učinkovitost zdravil Kogenate Bayer in Helixate NexGen je priznana, PRAC pa je pregledal podatke v zvezi z nastankom zaviralcev pri predhodno nezdravljenih bolnikih in minimalno zdravljenih bolnikih.
English: Kogenate Bayer/Helixate NexGen are indicated for treatment and prophylaxis of bleeding in patients with hemophilia A (congenital factor VIII deficiency).
Slovenian: Zdravili Kogenate Bayer in Helixate NexGen sta indicirani za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A (prirojenim pomanjkanjem faktorja VIII).
English: In patients given KOGENATE Bayer/Helixate NexGen, 64 out of 183 developed an inhibitor (37.7%), of which 40 had a high-titre inhibitor (25.2%).
Slovenian: Zaviralci so se razvili pri 64 od 183 (37,7 %) bolnikov, ki so prejemali zdravilo Kogenate Bayer ali Helixate NexGen, od tega jih je 40 (25,2 %) razvilo visok titer zaviralcev.
English: The PRAC therefore concluded that the benefit-risk balance of Kogenate Bayer and Helixate NexGen indicated as for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) remains favourable subject to the changes to the product information agreed.
Slovenian: Posledično je PRAC zaključil, da je razmerje med tveganji in koristmi zdravil Kogenate Bayer in Helixate NexGen, indiciranih za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A (prirojenim pomanjkanjem faktorja VIII), še naprej ugodno pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu.
English: Having noted the above, the PRAC concluded that the benefit-risk balance of Kogenate Bayer and Helixate NexGen indicated as for the treatment and prophylaxis of bleeding in patients with hemophilia A (congenital factor VIII deficiency) remains favourable subject to the changes to the product information agreed.
Slovenian: Ob upoštevanju vsega navedenega je PRAC zaključil, da je razmerje med tveganji in koristmi zdravil Kogenate Bayer in Helixate NexGen, indiciranih za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A (prirojenim pomanjkanjem faktorja VIII), še naprej ugodno pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu.
English: Five out of 37 (14%) PUP and 4 out of 23 (17%) MTP patients treated with Helixate NexGen developed inhibitors within 20 ED (exposure days).
Slovenian: Zaviralci so se v 20 dneh izpostavljenosti razvili pri petih od 37 (14 %) predhodno nezdravljenih bolnikov in 4 od 23 (17 %) minimalno zdravljenih bolnikov, ki so prejemali zdravilo Helixate NexGen.
English: Development of inhibitors against FVIII is the most significant complication of replacement therapy for haemophilia A. These antibodies inactivate the pro-coagulant activity of FVIII and inhibit patients' response to FVIII replacement therapy which may result in life-threatening bleedings and sequelae.
Slovenian: Ta protitelesa onemogočijo prokoagulacijsko aktivnost faktorja VIII in poslabšajo odziv bolnikov na nadomestno zdravljenje s faktorjem VIII, kar lahko vodi do smrtno nevarnih krvavitev in posledic.
English: Packaging Content (concentration) Package size
Slovenian: Vsebina (koncentracija) Velikost pakiranja
English: EU Number
Slovenian: Številka EU ime
English: Further information on Cyramza can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/cyramza.
Slovenian: Nadaljnje informacije o zdravilu Cyramza so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/cyramza.
English: Although the effects were modest, the size of the benefit was considered clinically relevant given the normally poor prognosis in these patients.
Slovenian: Čeprav so učinki skromni, je bil obseg koristi ocenjen kot klinično pomemben ob upoštevanju slabe prognoze, ki jo imajo običajno ti bolniki.
English: What measures are being taken to ensure the safe and effective use of Cyramza?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cyramza?
English: The European Medicines Agency decided that Cyramza's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Cyramza večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Cyramza received a marketing authorisation valid throughout the EU on 19 December 2014.
Slovenian: Za zdravilo Cyramza je bilo 19. decembra 2014 izdano dovoljenje za promet, veljavno po vsej EU.
English: It can only be obtained with a prescription and treatment should be started and supervised by a specialist who has experience in the treatment of cancer.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka.
English: As for all medicines, data on the use of Cyramza is continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Cyramza stalno spremljajo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cyramza have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Cyramza upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Other information about Cyramza
Slovenian: Druge informacije o zdravilu Cyramza
English: • non-small cell lung cancer that is advanced or has spread to other parts of the body.
Slovenian: • nedrobnoceličnega pljučnega raka, ki je napredoval ali se je razširil na druge dele telesa.
English: Why is Cyramza authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Cyramza odobreno v EU?
English: Side effects reported with Cyramza are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Cyramza, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Cyramza is a cancer medicine used to treat adult patients with:
Slovenian: Cyramza je zdravilo za zdravljenje raka, ki se uporablja pri odraslih bolnikih:
English: What benefits of Cyramza have been shown in studies?
Slovenian: Kakšne koristi zdravila Cyramza so se pokazale v študijah?
English: • hepatocellular carcinoma (a type of liver cancer) that is advanced or cannot be removed with surgery.
Slovenian: • hepatocelularnim karcinomom (vrsto jetrnega raka), ki je napredoval ali ga ni mogoče odstraniti s kirurškim posegom.
English: An overview of Cyramza and why it is authorised in the EU
Slovenian: Pregled zdravila Cyramza in zakaj je odobreno v EU
English: What is Cyramza and what is it used for?
Slovenian: Kaj je zdravilo Cyramza in za kaj se uporablja?
English: The benefit was smaller when Cyramza was given on its own, but this could still be an option when treatment with paclitaxel is not considered appropriate.
Slovenian: Koristi zdravila Cyramza so bile manjše, ko so ga dajali samostojno, vendar je tovrstna uporaba kljub temu lahko možnost, kadar se oceni, da zdravljenje s paklitakselom ni primerno.
English: VEGFRhelps in the development of new blood vessels that supply the tumours.
Slovenian: Ta receptor pomaga pri nastanku novih krvnih žil, ki oskrbujejo tumorje.
English: What are the risks associated with Cyramza?
Slovenian: Kakšna tveganja so povezana z zdravilom Cyramza?
English: The safety profile of Cyramza is in line with that expected for other medicines blocking VEGFR activity and is considered manageable.
Slovenian: Varnostni profil zdravila Cyramza je skladen s tistim, ki ga je mogoče pričakovati pri drugih zdravilih, ki zavirajo delovanje receptorja za VEGF, in je bil ocenjen kot sprejemljiv.
English: • metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body).
Slovenian: • metastatskega kolorektalnega raka (vrste rakavega obolenja debelega črevesa, ki se je razširil na druge dele telesa).
English: When used for lung cancer, Cyramza must not be used when there is a cavity in the cancer or if the cancer is close to a major blood vessel.
Slovenian: Kadar se zdravilo Cyramza uporablja za zdravljenje pljučnega raka, se ne sme uporabljati, kadar je v tumorju luknja ali če je rak blizu velikih krvnih žil.
English: By attaching to VEGFR, ramucirumab blocks this action, reducing the blood supply to the tumour and so slowing the growth of the cancer.
Slovenian: Ko se ramucirumab veže na ta receptor, zavira njegovo delovanje, s čimer zmanjša dotok krvi v tumor in s tem upočasni rast raka.
English: • advanced gastric cancer (cancer of the stomach) or cancer of the area where the gullet (oesophagus) enters the stomach (known as gastro-oesophageal junction adenocarcinoma).
Slovenian: • z napredovalim rakom želodca ali rakom predela, kjer požiralnik (ezofagus) vstopa v želodec (imenovanim adenokarcinom gastroezofagealnega prehoda).
English: The most common side effects with Cyramza (which may affect more than 1 in 10 people) include tiredness or weakness, leucopenia (low white blood cell counts), neutropenia (low counts of a particular type of white blood cell), diarrhoea, nosebleeds and stomatitis (inflammation of the lining of the mouth).
Slovenian: Najpogostejši neželeni učinki zdravila Cyramza (ki se lahko pojavijo pri več kot 1 bolniku od 10) so utrujenost ali šibkost, levkopenija (nizko število belih krvnih celic), nevtropenija (nizko število določene vrste belih krvnih celic), driska, krvavitve iz nosu in stomatitis (vnetje ustne sluznice).
English: The dose of Cyramza and how often it is given depends on the patient's weight and the condition being treated.
Slovenian: Odmerek zdravila Cyramza in pogostnost dajanja sta odvisna od bolnikove telesne mase in zdravljene bolezni.
English: For the full list of side effects of Cyramza, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov zdravila Cyramza glejte navodilo za uporabo.
English: Cyramza is used in combination with docetaxel in patients whose disease has worsened despite treatment with medicines containing platinum;
Slovenian: Zdravilo Cyramza se uporablja v kombinaciji z docetakselom pri bolnikih, pri katerih se je bolezen poslabšala kljub zdravljenju z zdravili, ki vsebujejo platino;
English: Cyramza also prolonged survival of patients with colorectal cancer, non-small cell lung cancer and hepatocellular carcinoma.
Slovenian: Zdravilo Cyramza je prav tako podaljšalo preživetje bolnikov s kolorektalnim rakom, nedrobnoceličnim pljučnim rakom in hepatocelularnim karcinomom.
English: Similarly, in another study in 355 patients, those treated with Cyramza plus best supportive care lived longer than patients receiving placebo plus best supportive care (an average of 5.2 months versus 3.8 months, respectively).
Slovenian: Podobno so v drugi študiji s 355 bolniki tisti, ki so se zdravili z zdravilom Cyramza v kombinaciji z najboljšo podporno nego, živeli dlje kot bolniki, ki so se zdravili s placebom v kombinaciji z najboljšo podporno nego (v povprečju 5,2 meseca v primerjavi s 3,8 meseca).
English: Cyramza is used in combination with another medicine, paclitaxel, or on its own if the combination with paclitaxel is not appropriate, in patients whose disease has worsened despite treatment with medicines containing platinum or fluoropyrimidines (a class of medicines that includes capecitabine, fluorouracil and tegafur);
Slovenian: Zdravilo Cyramza se uporablja v kombinaciji z drugim zdravilom, paklitakselom, ali samostojno, če kombinacija s paklitakselom ni primerna, pri bolnikih, pri katerih se je bolezen poslabšala kljub zdravljenju z zdravili, ki vsebujejo platino ali fluoropirimidine (razred zdravil, ki vključuje kapecitabin, fluorouracil in tegafur);
English: Cyramza is used on its own in patients with a high blood level of a protein called alpha fetoprotein (AFP) and who have been previously treated with sorafenib.
Slovenian: Zdravilo Cyramza se uporablja samostojno pri bolnikih z visokimi koncentracijami beljakovine, imenovane alfafetoprotein (AFP), v krvi, ki so predhodno že bili zdravljeni s sorafenibom.
English: The most serious adverse effects reported (either of Cyramza alone or in combination with other cancer medicines) included gastrointestinal perforation (a hole that develops in the wall of the gut), severe gastrointestinal haemorrhage (bleeding from the gut) and arterial thromboembolic events
Slovenian: Najresnejši neželeni učinki, o katerih so poročali (bodisi pri uporabi samega zdravila Cyramza ali v kombinaciji z drugimi zdravili za zdravljenje raka), so vključevali predrtje prebavil (luknja, ki nastane v steni črevesja), hudo gastrointestinalno krvavitev (krvavitev iz črevesja) in arterijske trombembolične dogodke (težave, ki jih povzročijo krvni strdki in zamašitev arterij).
English: Treatment should continue for as long as the patient benefits from it. For more information about using Cyramza, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Cyramza glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Cyramza is given by infusion (drip) into a vein.
Slovenian: Zdravilo Cyramza se daje z infundiranjem (kapalno infuzijo) v veno.
English: The active substance in Cyramza, ramucirumab, is a monoclonal antibody (a type of protein) designed to attach to vascular endothelial growth factor receptor (VEGFR), a protein present at high levels in tumours.
Slovenian: Učinkovina v zdravilu Cyramza, ramucirumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da se veže na receptor za žilni endotelijski rastni faktor (VEGF).
English: How does Cyramza work?
Slovenian: Kako zdravilo Cyramza deluje?
English: The Agency noted that Cyramza prolonged the lives of patients with gastric and gastro-oesophageal junction cancer when it was given with paclitaxel.
Slovenian: Ugotovila je, da je zdravilo Cyramza podaljšalo življenje bolnikov z rakom želodca in rakom gastroezofagealnega prehoda, kadar se je uporabljalo skupaj s paklitakselom.
English: Cyramza contains the active substance ramucirumab.
Slovenian: Zdravilo Cyramza vsebuje učinkovino ramucirumab.
English: Cyramza is used with ‘FOLFIRI' chemotherapy (a combination of fluorouracil, folinic acid and irinotecan) in patients whose disease has worsened despite treatment with bevacizumab, oxaliplatin and a fluoropyrimidine;
Slovenian: Zdravilo Cyramza se uporablja skupaj s kemoterapijo FOLFIRI (kombinacijo fluorouracila, folinske kisline in irinotekana) pri bolnikih, pri katerih se je bolezen poslabšala kljub zdravljenju z bevacizumabom, oksaliplatinom in fluoropirimidinom;
English: How is Cyramza used?
Slovenian: Kako se zdravilo Cyramza uporablja?
English: In a study involving 292 patients with hepatocellular carcinoma that is advanced or cannot be removed with surgery and who have high AFP blood level and have been previously treated with sorafenib, patients receiving Cyramza lived longer than those receiving placebo: 8.5 versus 7.3 months, respectively.
Slovenian: V študiji, v katero je bilo vključenih 292 bolnikov s hepatocelularnim karcinomom, ki je napredoval ali ga ni mogoče odstraniti s kirurškim posegom ter so imeli visoke koncentracije alfafetoproteina v krvi in so se predhodno zdravili s sorafenibom, so bolniki, ki so prejemali zdravilo Cyramza, živeli dlje kot tisti, ki so prejemali placebo: 8,5 meseca v primerjavi s 7,3 meseca.
English: Cyramza increased survival of patients with advanced gastric or gastro-oesophageal junction cancer, metastatic colorectal cancer, advanced or metastatic non-small cell lung cancer and hepatocellular carcinoma in 5 main studies.
Slovenian: V petih glavnih študijah je bilo dokazano, da je zdravilo Cyramza podaljšalo preživetje bolnikov z napredovalim rakom želodca ali rakom gastroezofagealnega prehoda, metastatskim kolorektalnim rakom, napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom in hepatocelularnim karcinomom.
English: In one main study involving 665 patients with advanced gastric or gastro-oesophageal junction cancer which worsened despite treatment with medicines containing platinum and a fluoropyrimidine, those treated with Cyramza and paclitaxel lived longer than patients receiving paclitaxel and placebo (a dummy treatment): on average 9.6 months versus 7.4 months respectively.
Slovenian: V eni glavni študiji, v katero je bilo vključenih 665 bolnikov z napredovalim rakom želodca ali rakom gastroezofagealnega prehoda, pri katerih se je bolezen poslabšala kljub zdravljenju z zdravili, ki vsebujejo platino in fluoropirimidin, so bolniki, ki so prejemali zdravilo Cyramza in paklitaksel, živeli dlje kot bolniki, ki so prejemali paklitaksel in placebo (zdravilo brez učinkovine): v povprečju 9,6 meseca v primerjavi s 7,4 meseca.
English: In a main study involving 1,072 patients with metastatic colorectal cancer which worsened despite treatment with bevacizumab, oxaliplatin and a fluoropyrimidine, those treated with Cyramza and FOLFIRI lived longer than patients receiving FOLFIRI and placebo: on average 13.3 months versus 11.7 months respectively.
Slovenian: V eni glavni študiji, v katero je bilo vključenih 1 072 bolnikov z metastatskim kolorektalnim rakom, pri katerih se je bolezen poslabšala kljub zdravljenju z bevacizumabom, oksaliplatinom ali fluoropirimidinom, so bolniki, zdravljeni z zdravilom Cyramza in kemoterapijo FOLFIRI, živeli dlje kot bolniki, ki so prejemali kemoterapijo FOLFIRI in placebo: v povprečju 13,3 meseca v primerjavi z 11,7 meseca.
English: In a main study involving 1,253 patients with advanced or metastatic non-small cell lung cancer which worsened despite treatment with medicines containing platinum, those treated with Cyramza and docetaxel lived longer than patients receiving docetaxel and placebo: on average 10.5 months versus 9.1 months respectively.
Slovenian: V drugi glavni študiji, v katero je bilo vključenih 1 253 bolnikov z napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih se je bolezen poslabšala kljub zdravljenju z zdravili, ki vsebujejo platino, so bolniki, ki so prejemali zdravilo Cyramza in docetaksel, živeli dlje kot bolniki, ki so prejemali docetaksel in placebo: v povprečju 10,5 meseca v primerjavi z 9,1 meseca.
English: Permeability/Absorption
Slovenian: Permeabilnost/absorpcija
English: • The Committee considered the notification of the referral triggered by the United Kingdom under Article 29(4) of Directive 2001/83/EC;
Slovenian: • odbor je upošteval obvestilo o napotitvenem postopku, ki ga je sprožilo Združeno kraljestvo skladno s členom 29(4) Direktive 2001/83/ES;
English: Overall summary of the scientific evaluation of Okrido and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Okrido in povezanih imen (glejte Prilogo I)
English: The rapid resolution of symptoms was comparable to i.v.
Slovenian: Hitro prenehanje simptomov je bilo primerljivo z i.v.
English: Sorbitol is a non-absorbable sugar alcohol that is used in ‘sugar-free' formulations because it does not crystallise around the bottle opening and cap.
Slovenian: Sorbitol je sladkorni alkohol, ki se ne absorbira in se uporablja v pripravkih „brez sladkorja”, saj ne kristalizira okrog odprtine in pokrovčka stekleničke.
English: • The Committee reviewed all the data submitted by the marketing authorisation holder to address the potential serious risk to public health with regard to the efficacy and safety for Okrido 6 mg/ml oral solution.
Slovenian: • odbor je pregledal vse podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom za obravnavo možnega resnega tveganja za javno zdravje v zvezi z učinkovitostjo in varnostjo zdravila Okrido 6 mg/ml peroralna raztopina;
English: Efficacy was measured by patients and physician by rating resolution of symptoms as well as safety and tolerability.
Slovenian: Učinkovitost so merili bolniki in zdravniki, tako da so ocenjevali prenehanje simptomov, kakor tudi varnost in prenašanje zdravila.
English: The data submitted by the MAH in support of this application were assessed, and a summary is provided below:
Slovenian: Ocenili so podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom v podporo tej vlogi, povzetek pa je zapisan v nadaljevanju:
English: • The Committee also noted the literature data that was submitted, which showed that sorbitol in oral prednisolone solutions would not exert a clinically relevant effect in terms of efficacy and safety, although recognised that this literature was less relevant to the consideration of the biowaver.
Slovenian: • odbor je upošteval tudi predložene podatke iz literature, ki so pokazali, da sorbitol v peroralnih raztopinah prednizolona nima klinično pomembnega učinka v smislu učinkovitosti in varnosti, čeprav je odbor upošteval tudi, da je ta literatura manj pomembna za obravnavo izvzetja študij biološke enakovrednosti;
English: Considering that the reference medicinal product and Okrido are oral solutions at the time of administration, the following provision of Appendix II of the Guideline on Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98, Rev.1) is applicable:
Slovenian: Ob upoštevanju dejstva, da sta v času dajanja referenčno zdravilo in zdravilo Okrido peroralni raztopini, velja naslednja določba Dodatka II Smernice o preiskovanju biološke enakovrednosti (CPMP/EWP/QWP/1401/98, Rev. 1):
English: The proposed indications for Okrido oral solution 6mg/ml include a wide range of conditions where symptomatic anti-inflammatory/ immunosuppressive therapy is required.
Slovenian: Predlagane indikacije za zdravilo Okrido peroralna raztopina 6 mg/ml vključujejo širok razpon bolezni, pri katerih je potrebno simptomatsko protivnetno/imunosupresivno zdravljenje.
English: Solubility and dissolution
Slovenian: Topnost in raztapljanje
English: For Okrido, this equates to 0.536 mg/ml for prednisolone phosphate.
Slovenian: Za zdravilo Okrido to ustreza 0,536 mg/ml za prednizolon fosfat.
English: This is in accordance with bioavailability literature data of prednisolone.
Slovenian: To je v skladu s podatki iz literature o biološki uporabnosti prednizolona.