natgillin/translations-raw huggingface dataset:
Among these patients, 36 had chronic phase CML and 16 had either accelerated or blast phase CML.
Med temi bolniki jih je 36 imelo kronično mieloično levkemijo v kronični fazi in 16 v pospešeni ali blastni fazi.
A second study in 536 newly diagnosed CML patients in the ‘chronic phase' compared Bosulif with imatinib.
V drugi študiji pri 536 novo diagnosticiranih bolnikih s kronično mieloično levkemijo v „kronični fazi‟ so zdravilo Bosulif primerjali z imatinibom.
It can only be obtained with a prescription and treatment should be started by a doctor who is experienced in the diagnosis and treatment of CML.
Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem kronične mieloične levkemije.
Bosulif is a cancer medicine that is used to treat chronic myeloid leukaemia (CML), a cancer of the white blood cells, in adults with a special chromosome in their cells called the Philadelphia chromosome.
Bosulif je zdravilo proti raku, ki se uporablja za zdravljenje kronične mieloične levkemije (KML), tj. raka belih krvnih celic, pri odraslih s posebnim kromosomom v celicah, imenovanim kromosom Philadelphia.
Of these, 52 patients were considered to have an unmet medical need, because disease resistance or the risk of severe side effects made other tyrosine kinase inhibitors unsuitable.
Od teh bolnikov jih je bilo 52 opredeljenih kot takšnih, pri katerih zdravstvene potrebe večinoma niso bile izpolnjene, ker so drugi zaviralci tirozin-kinaze zaradi odpornosti bolezni ali tveganja za resne neželene učinke zanje neprimerni.
What information is still awaited for Bosulif?
Katere informacije o zdravilu Bosulif še pričakujemo?
Bosulif treatment was effective in patients with an unmet medical need: 18 out of 36 patients with chronic phase CML had a ‘major cytogenetic response', while 7 out of the 16 patients with advanced (accelerated or blast phase) CML also had a sufficient response based on other measurements.
Zdravljenje z zdravilom Bosulif je bilo učinkovito pri bolnikih, katerih zdravstvene potrebe večinoma niso bile izpolnjene: 18 od 36 bolnikov s kronično mieloično levkemijo v kronični fazi je imelo „pomembni citogenetski odziv‟, medtem ko je imelo 7 od 16 bolnikov z napredovalo boleznijo (v pospešeni ali blastni fazi) prav tako zadovoljiv odziv na podlagi drugih meritev.
The main measure of effectiveness was the number of patients who had at least a ‘major cytogenetic response' (where the proportion of white blood cells with the Philadelphia chromosome fell below 35%) after six months of Bosulif treatment.
Glavno merilo učinkovitosti je bilo število bolnikov, ki so imeli najmanj „pomembni citogenetski odziv“ (pri katerih je delež belih krvnih celic s kromosomom Philadelphia padel pod 35 %) po šestih mesecih zdravljenja z zdravilom Bosulif.
For more information about using Bosulif, see the package leaflet or contact a doctor or pharmacist.
Za več informacij glede uporabe zdravila Bosulif glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Studies have shown that Bosulif is effective at reducing the proportion of white blood cells with the Philadelphia chromosome.
Študije so pokazale, da je zdravilo Bosulif učinkovito pri zmanjševanju deleža belih krvnih celic s kromosomom Philadelphia.
It is used to treat three stages of CML called ‘chronic phase', ‘accelerated phase' and ‘blast phase' in patients who have already been treated with one or more tyrosine kinase inhibitors (medicines for CML which work in a similar way to Bosulif), and when the tyrosine kinase inhibitors called dasatinib, imatinib and nilotinib are not suitable.
Uporablja se za zdravljenje treh faz kronične mieloične levkemije, imenovanih „kronična faza‟, „pospešena faza‟ in „blastna faza‟, pri bolnikih, ki so se že zdravili z enim ali več zaviralci tirozin-kinaze (zdravili za zdravljenje kronične mieloične levkemije, ki delujejo podobno kot zdravilo Bosulif), in kadar zaviralci tirozin-kinaze, imenovani dasatinib, imatinib in nilotinib, niso primerni.
The main measure of effectiveness was the number of patients who had a ‘major molecular response' (where the amount in the bone marrow of BCR-ABL, the protein produced by the Philadelphia chromosome, is greatly lowered).
Glavno merilo učinkovitosti je bilo število bolnikov, ki so imeli „pomembni citogenetski odziv‟ (pri katerih je količina beljakovine BCR-ABL v kostnem mozgu, ki jo proizvaja kromosom Philadelphia, bistveno zmanjšana).
The most serious side effects (which may affect more than 1 in 20 people) include thrombocytopenia, anaemia, diarrhoea, rash, neutropenia (low levels of neutrophils, a type of white blood cell) and blood tests suggesting damage to the liver and pancreas.
Najresnejši neželeni učinki (ki se lahko pojavijo pri več kot 1 bolniku od 20) vključujejo trombocitopenijo, anemijo, drisko, izpuščaj, nevtropenijo (nizke vrednosti nevtrofilcev, vrste belih krvnih celic) in izvidi krvnih preiskav, ki kažejo na poškodbo jeter in trebušne slinavke.
For the full list of all side effects reported with Bosulif, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Bosulif, glejte navodilo za uporabo.
Bosulif has been shown to improve the condition of patients with CML, including by reducing the number of cancer cells with the Philadelphia chromosome and returning white blood cell levels to normal.
Zdravilo Bosulif dokazano izboljša stanje bolnikov s kronično mieloično levkemijo, vključno z zmanjšanjem števila rakavih celic s kromosomom Philadelphia in vrnitvijo ravni belih krvnih celic na normalno.
The most common side effects with Bosulif (which may affect more than 1 in 5 people) are diarrhoea, nausea (feeling sick), thrombocytopenia (low blood platelet counts), abdominal pain (belly ache), vomiting, rash, anaemia (low red blood cell counts), tiredness, fever and increased levels of liver enzymes.
Najpogostejši neželeni učinki zdravila Bosulif (ki se lahko pojavijo pri več kot 1 bolniku od 5) so driska, navzeja (siljenje na bruhanje), trombocitopenija (nizko število trombocitov v krvi), bolečine v trebuhu, bruhanje, izpuščaj, anemija (nizko število rdečih krvnih celic), utrujenost, povišana telesna temperatura in povišane vrednosti jetrnih encimov.
By blocking their action, Bosulif helps to control cell division, thereby controlling the growth and spread of the leukaemia cells in CML.
Zdravilo Bosulif z zaviranjem delovanja celic pomaga nadzorovati njihovo delitev, s tem pa nadzira rast in širjenje levkemičnih celic pri kronični mieloični levkemiji.
Since Bosulif has been granted a conditional approval, the company that markets Bosulif will carry out and submit the results of a larger study with Bosulif in patients with Ph+ CML previously treated with one or more tyrosine kinase inhibitors and for whom dasatinib, imatinib and nilotinib are not considered appropriate treatment options.
Ker je zdravilo Bosulif pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, opravila obsežnejšo študijo z zdravilom Bosulif pri bolnikih s KML Ph+, ki so se predhodno že zdravili z enim ali več zaviralci tirozin-kinaze in za katere se dasatinib, imatinib in nilotinib ne štejejo za primerne možnosti, ter predložila njene rezultate.
How is Bosulif used?
Kako se zdravilo Bosulif uporablja?
How does Bosulif work?
Kako zdravilo Bosulif deluje?
Bosulif is also used to treat newly diagnosed patients who are in the ‘chronic phase' of CML.
Zdravilo Bosulif se uporablja tudi pri novo diagnosticiranih bolnikih s kronično mieloično levkemijo kronični fazi.
London, 23 October 2008 Doc.
London, 23. oktobra 2008 Sklic na dok.
International non-proprietary name (INN): lacosamide
Mednarodno nelastniško ime (INN): lakosamid
This withdrawal has no consequences on Vimpat, for which the balance of benefits and risks remains unchanged.
Umik nima nobenih posledic za zdravilo Vimpat, za katerega razmerje med koristmi in tveganji ostaja nespremenjeno.
The main measure of effectiveness was the change in pain levels between the start of the study and the last four weeks on the stable dose.
Glavno merilo učinkovitosti je bila sprememba v ravneh bolečine ob začetku študije ter v zadnjih štirih tednih ob prejemanju stabilnega odmerka.
The effectiveness of three doses of Lacosamide Pain UCB Pharma (200, 400 and 600 mg per day) was compared with that of placebo (a dummy treatment) in a total of 1,724 patients in four main studies.
Učinkovitost treh odmerkov zdravila Lacosamide Pain UCB Pharma (200, 400 in 600 mg na dan) so primerjali s placebom (zdravilom brez zdravilne učinkovine) pri skupaj 1 724 bolnikih v štirih glavnih študijah.
The exact way in which lacosamide works is still unclear, but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells.
Natančen način delovanja lakosamida še vedno ni jasen, vendar se zdi, da zmanjša dejavnost natrijevih kanalov (por na površini živčnih celic), ki omogočajo, da se električni impulzi prenašajo med živčnimi celicami.
Ref. EMEA/522632/2008
EMEA/605943/2008 Error!
Lacosamide has been authorised in the European Union (EU) as an anti-epileptic medicine under the trade name Vimpat since August 2008.
Lakosamid je v Evropski uniji odobren kot antiepileptično zdravilo pod lastniškim imenom Vimpat od avgusta 2008.
Together, these actions are expected to prevent abnormal electrical activity in nerve cells, reducing pain due to nerve damage.
Pričakuje se, da te dejavnosti skupaj preprečujejo električno dejavnost v živčnih celicah in tako zmanjšujejo bolečino zaradi poškodbe živcev.
Pain was measured by the patients on an 11-point scale.
Bolniki so bolečino merili s pomočjo 11-stopenjske lestvice.
In all four studies, the dose of Lacosamide Pain UCB Pharma was increased gradually over a few weeks before being maintained at a stable dose for 12 weeks.
V vseh štirih študijah so odmerek zdravila Lacosamide Pain UCB Pharma postopoma povečevali v obdobju nekaj tednov, nato pa 12 tednov vzdrževali na stabilni ravni.
The application was at day 181 when the company withdrew.
Družba je vlogo umaknila na 181. dan postopka.
The effects of Lacosamide Pain UCB Pharma were first tested in experimental models before being studied in humans.
Učinki zdravila Lacosamide Pain UCB Pharma so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
What is happening with Vimpat used for the treatment of epilepsy?
Kaj to pomeni za nadaljnjo uporabo zdravila Vimpat, ki se uporablja za zdravljenje epilepsije?
Lacosamide Pain UCB Pharma was expected to be used in adults to treat pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
Zdravilo Lacosamide Pain UCB Pharma naj bi se uporabljalo pri odraslih za zdravljenje bolečine, ki jo povzroča diabetična periferna nevropatija (poškodbe živcev v okončinah, ki se lahko pojavijo pri bolnikih z diabetesom).
Lacosamide is also thought to be involved in the development of nerve cells that have been damaged.
Zdi se, da lakosamid sodeluje tudi pri razvoju živčnih celic, ki so bile poškodovane.
On 25 September 2008, UCB Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Lacosamide Pain UCB Pharma, for the treatment of diabetic neuropathic pain in adults.
Družba UCB Pharma S.A. je dne 25. septembra 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Lacosamide Pain UCB Pharma, namenjenim zdravljenju boleče diabetične nevropatije pri odraslih.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Lacosamide Pain UCB Pharma could not have been approved for the treatment of diabetic neuropathic pain in adults.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP v času umika vloge, je imel Odbor zadržke in je začasno menil, da zdravila Lacosamide Pain UCB Pharma ni mogoče odobriti za zdravljenje boleče diabetične nevropatije pri odraslih.
Questions and answers on the withdrawal of the marketing application for Lacosamide Pain UCB Pharma
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Lacosamide Pain UCB Pharma
The medicine can also cause side effects affecting the heart and central nervous system (such as dizziness), which are of concern in patients with diabetes.
Zdravilo lahko povzroči tudi neželene učinke, ki vplivajo na srce in osrednji živčni sistem (kot je omotica).
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Lacosamide Pain UCB Pharma?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Lacosamide Pain UCB Pharma?
The CHMP was concerned that the studies had not shown a meaningful benefit of Lacosamide Pain UCB Pharma.
CHMP je izrazil pomislek, da študije niso dokazale bistvene koristi zdravila Lacosamide Pain UCB Pharma.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Lacosamide Pain UCB Pharma had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
CHMP je zato v času umika menil, da koristi zdravila Lacosamide Pain UCB Pharma niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Lacosamide Pain UCB Pharma.
Družba je obvestila CHMP, da za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe z zdravilom Lacosamide Pain UCB Pharma, ni nobenih posledic.
What is Lacosamide Pain UCB Pharma?
Kaj je zdravilo Lacosamide Pain UCB Pharma?
Lacosamide Pain UCB Pharma contains the active substance lacosamide.
Zdravilo Lacosamide Pain UCB Pharma vsebuje zdravilno učinkovino lakosamid.
How is Lacosamide Pain UCB Pharma expected to work?
Kako naj bi zdravilo Lacosamide Pain UCB Pharma delovalo?
What was Lacosamide Pain UCB Pharma expected to be used for?
Za kaj naj bi se zdravilo Lacosamide Pain UCB Pharma uporabljalo?
Medicinal product no longer authorised
Številka (EU) dovoljenja za promet
Subcutaneous use pre-filled syringe 1.0 ml (150 mg/ml) 3 (3 x 1) pre-filled syringes (multipack)
1,0 ml (150 mg/ml) 3 (3 x 1) napolnjene injekcijske brizge (večkratno pakiranje)
Subcutaneous use pre-filled pen 1.0 ml (150 mg/ml) 3 (3 x 1) pre-filled pens (multipack)
1,0 ml (150 mg/ml) 3 (3 x 1) napolnjeni injekcijski peresniki (večkratno pakiranje)
Subcutaneous use pre-filled syringe 1.0 ml (150 mg/ml) 1 pre-filled syringe
1,0 ml (150 mg/ml) 1 napolnjena injekcijska brizga
Subcutaneous use pre-filled pen 1.0 ml (150 mg/ml) 1 pre-filled pen
1,0 ml (150 mg/ml) 1 napolnjen injekcijski peresnik
Treatment should not be stopped abruptly.
Zdravljenje se ne sme prekiniti nenadoma.
The European Commission granted a marketing authorisation valid throughout the European Union for INOmax on 1 August 2001.
Evropska komisija je dovoljenje za promet z zdravilom INOmax, veljavno po vsej Evropski uniji, odobrila dne 1. avgusta 2001.
In children and adults undergoing heart surgery, treatment usually lasts for 24 to 48 hours.
Pri otrocih in odraslih pred operacijo srca zdravljenje običajno traja od 24 do 48 ur.
INOmax nitric oxide
INOmax dušikov oksid
This should then be reduced to 5 ppm, provided the blood in the arteries contains enough oxygen.
To je treba kasneje zmanjšati na 5 ppm, če kri v arterijah vsebuje dovolj kisika.
The full EPAR for INOmax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo INOmax je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This is a summary of the European public assessment report (EPAR) for INOmax.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo INOmax.
It also helps to decrease inflammation in the lungs.
Pomaga tudi pri zmanjševanju vnetij v pljučih.
The maximum starting dose of INOmax is 20 ppm for children up to 18 years of age, and 40 ppm for adults.
Največji začetni odmerek zdravila INOmax je 20 ppm za otroke do 18. leta starosti in 40 ppm za odrasle.
For more information about treatment with INOmax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist..
Za več informacij o zdravljenju z zdravilom INOmax preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What measures are being taken to ensure the safe use of INOmax?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila INOmax?
• newborn babies (born after 34 weeks of gestation) with breathing problems associated with pulmonary hypertension (high blood pressure in the lungs).
• novorojenčkih (rojeni po 34. tednu nosečnosti) s težavami pri dihanju zaradi pljučne hipertenzije (visok krvni tlak v pljučih).
The company must put in place an educational programme to ensure that doctors who are going to use INOmax for the treatment of patients undergoing heart surgery are aware of the risks and the precautions necessary when using the medicine.
Družba mora pripraviti izobraževalni program za zdravnike, ki bodo zdravilo INOmax uporabljali pri zdravljenju bolnikov pred operacijo srca, ter tako zagotoviti njihovo poznavanje tveganj in previdnostnih ukrepov pri uporabi zdravila.
The main measure of effectiveness was the proportion of neonates who died or needed ECMO over the first 120 days in hospital.
Glavno merilo učinkovitosti je bil delež novorojenčkov, ki so umrli ali so potrebovali zunajtelesno membransko oksigenacijo v prvih 120 dneh v bolnišnici.
INOmax treatment should be supervised by a doctor who has experience in intensive care or neonatal intensive care if the patient is a newborn baby.
Zdravljenje z zdravilom INOmax mora nadzorovati zdravnik, ki ima izkušnje z intenzivno nego ali intenzivno nego novorojenčkov, če je bolnik novorojenček.
The Committee for Medicinal Products for Human Use (CHMP) decided that INOmax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila INOmax večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
• patients of all ages who are undergoing or have undergone heart surgery and develop pulmonary hypertension.
• bolnikih vseh starosti, pri katerih bo ali je bil opravljen kirurški poseg na srcu in pri katerih se je pojavila pljučna hipertenzija.
What benefit has INOmax shown during the studies?
Kakšne koristi je zdravilo INOmax izkazalo med študijami?
It must not be used in babies who have right-to-left or significant left-to-right shunting of blood (abnormal circulation of blood in the heart).
Prav tako se ne sme uporabljati pri dojenčkih, ki imajo obvod krvi z desne na levo ali izrazit obvod krvi z leve na desno (nenormalen obtok krvi v srcu).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for INOmax.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo INOmax, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Other information about INOmax
Druge informacije o zdravilu INOmax:
INOmax is a gas for inhalation that contains the active substance nitric oxide diluted in nitrogen gas at 400 or 800 parts per million (ppm).
Zdravilo INOmax je plin za inhaliranje, ki vsebuje zdravilno učinkovino dušikov oksid, razredčen v plinu dušiku v koncentraciji 400 ali 800 delcev na milijon (ppm).
INOmax is used in combination with artificial ventilation and other medicines to help improve blood oxygen levels in the following groups of patients:
Zdravilo INOmax se uporablja v kombinaciji z umetnim predihavanjem in drugimi zdravili za izboljšanje koncentracije kisika v krvi pri naslednjih skupinah bolnikov:
The most common side effect with INOmax (seen in more than 1 patient in 10) are thrombocytopenia (low blood platelet counts), hypokalaemia (low blood potassium levels), hypotension (low blood pressure), atelectasis (collapse of the whole, or part of a, lung), and hyperbilirubinaemia (high blood levels of bilirubin).
Najpogostejši neželeni učinki zdravila INOmax (opaženi pri več kot 1 bolniku izmed 10) je trombocitopenija (nizka koncentracija trombocitov v krvi), hipokaliemija (nizka raven kalija v krvi), hipotenzija (nizek krvni tlak), atelektaza (kolaps celih pljuč ali dela pljuč) in hiperbilirubinemija (visoka koncentracija bilirubina v krvi).
INOmax should not be used in babies who may be hypersensitive (allergic) to nitric oxide or the other ingredient (nitrogen).
Zdravilo INOmax se ne sme uporabljati pri dojenčkih, ki utegnejo biti preobčutljivi za (alergični na) dušikov oksid ali drugo sestavino zdravila (dušik).
In the second main study, 30 (31%) of the neonates receiving INOmax needed ECMO, compared with 51 (57%) of the 89 receiving placebo.
V drugi glavni študiji je zunajtelesno membransko oksigenacijo potrebovalo 30 (31 %) novorojenčkov, ki so prejemali zdravilo INOmax, v primerjavi z 51 (57 %) izmed 89 novorojenčkov, ki so prejemali placebo.
INOmax is given after being diluted in an oxygen/air mixture supplied to the patient through the ventilator.
Zdravilo INOmax se daje razredčeno v mešanici kisika/zraka, ki se bolniku dovaja skozi ventilator.
In the first main study, 52 (46%) of the 114 neonates receiving INOmax died or needed ECMO, compared with 77 (64%) of the 121 receiving placebo.
V prvi glavni študiji je umrlo ali potrebovalo zunajtelesno membransko oksigenacijo 52 (46 %) izmed 114 novorojenčkov, ki so prejemali zdravilo INOmax, v primerjavi s 77 (64 %) izmed 121 novorojenčkov, ki so prejemali placebo.
INOmax has also been studied in 421 neonates from 34 weeks gestation with pulmonary hypertension in two main studies.
Zdravilo INOmax so proučevali tudi v dveh glavnih študijah s 421 novorojenčki s pljučno hipertenzijo, rojenimi po vsaj 34 tednih nosečnosti.
In the published literature, INOmax treatment was shown to reduce the blood pressure in the lungs and improve heart function when used during or after heart surgery.
V objavljeni literaturi se je izkazalo, da je zdravljenje z zdravilom INOmax znižalo krvni tlak v pljučih in izboljšalo delovanje srca, kadar je bilo uporabljeno med operacijo srca ali po njej.
In these patients INOmax is used to help improve heart function and reduce blood pressure in the lungs.
Pri teh bolnikih se zdravilo INOmax uporablja za izboljšanje delovanje srca in znižanje krvnega tlaka v pljučih.
INOmax should only be used in units where staff have been trained in the use of a nitric oxide delivery system.
Zdravilo INOmax se sme uporabljati samo na oddelkih, katerih osebje je usposobljeno za uporabo sistema za dovajanje dušikovega oksida.
What is the risk associated with INOmax?
Kakšna tveganja so povezana z zdravilom INOmax?
The marketing authorisation holder is Linde Healthcare AB.
Imetnik dovoljenja za promet z zdravilom je družba Linde Healthcare AB.
This was mainly due to a reduction in the need for ECMO, rather than a reduction in death rates.
Razlika je bila pretežno pogojena z zmanjšanjem potrebe po zunajtelesni membranski oksigenaciji in ne zmanjšanjem smrtnosti.