natgillin/translations-raw huggingface dataset:
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 Reyataz. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Reyataz, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
For adults (aged 18 years or over), the recommended dose is 300 mg once a day. 
Priporočeni odmerek zdravila za odrasle (starejše od 18 let) je 300 mg enkrat na dan.
The patients also had improvements in their immune systems. 
Pri bolnikih se je izboljšal tudi imunski sistem.
Reyataz is normally given with ritonavir to boost its action but doctors can consider stopping ritonavir in adults in some specific situations. 
Zdravilo Reyataz se običajno daje z ritonavirjem za okrepitev njegovega delovanja, zdravniki pa lahko v nekaterih posebnih primerih razmislijo o prenehanju dajanja ritonavirja pri odraslih.
In all of the studies, the patients also took two nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs, a type of antiviral medicine). 
V vseh študijah so bolniki jemali tudi dva nukleozidna ali nukleotidna zaviralca reverzne transkriptaze (NRTI, vrsta protivirusnega zdravila).
Reyataz does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS. 
Zdravilo Reyataz ne zdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
Reyataz, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. 
Zdravilo Reyataz v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusa HIV v krvi in jo vzdržuje na nizki ravni.
A measure of effectiveness was the viral load after treatment for 48 weeks. 
Merilo učinkovitosti je bilo virusno breme po 48-tedenskem zdravljenju.
The main measure of effectiveness was the change in the levels of HIV in the patients' blood (viral load). 
Glavno merilo učinkovitosti je bila sprememba koncentracije virusa HIV (virusnega bremena) v bolnikovi krvi.
In younger patients, the dose of Reyataz depends on body weight. 
Pri mlajših bolnikih je odmerek zdravila Reyataz odvisen od njihove telesne mase.
In studies, side effects were similar in younger patients. 
V študijah so bili pri mlajših bolnikih ugotovljeni podobni neželeni učinki.
The medicine is not expected to work in patients in whom many medicines in the same class as Reyataz (protease inhibitors) do not work. 
Ni pričakovati, da bi zdravilo učinkovalo pri bolnikih, pri katerih številna zdravila istega razreda kot zdravilo Reyataz (zaviralci proteaze) ne učinkujejo.
The study looked at the effect of the medicine on viral load and on the immune system, among other measures. 
V študiji so med drugim proučevali učinek zdravila na virusno breme in imunski sistem.
In addition, Reyataz must not be given to patients taking rifampicin (used to treat tuberculosis), sildenafil (when this medicine is used to treat pulmonary arterial hypertension), St John's wort (a herbal medicine used to treat depression) or medicines that are broken down in the body in the same way as Reyataz and are harmful at high levels in the blood. 
Prav tako se ga ne sme dajati bolnikom, ki jemljejo rifampicin (zdravilo za zdravljenje tuberkoloze), sildenafil (kadar se uporablja za zdravljenje pljučne arterijske hipertenzije), šentjanževko (zeliščni pripravek za zdravljenje depresije) ali zdravila, ki se v telesu presnavljajo enako kot zdravilo Reyataz in so v velikih količinah v krvi škodljiva.
In adults, the most common side effects with Reyataz (seen in between 1 and 10 patients in 100) are headache, ocular icterus (yellowing of the eyes), vomiting, diarrhoea, abdominal pain (stomach ache), nausea (feeling sick), dyspepsia (heartburn), rash, fatigue (tiredness) and jaundice (yellowing of the skin and eyes because of liver problems). 
Pri odraslih so najpogostejši neželeni učinki zdravila Reyataz (opaženi pri 1 do 10 bolnikov od 100) glavobol, očesni ikterus (rumeno obarvanje oči), bruhanje, driska, bolečine v trebuhu, navzeja (slabost), dispepsija (zgaga), izpuščaji, utrujenost in zlatenica (porumenitev kože in oči zaradi okvare jeter).
What is the risk associated with Reyataz? 
Kakšna tveganja so povezana z zdravilom Reyataz?
Reyataz is used together with low-dose ritonavir and other antiviral medicines to treat adults and children aged 3 months and over and weighing at least 5 kg who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). 
Zdravilo Reyataz se uporablja v kombinaciji z nizkim odmerkom ritonavirja in drugimi protivirusnimi zdravili za zdravljenje odraslih in otrok, starejših od treh mesecev s telesno maso najmanj pet kg, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
Reyataz must not be used in patients who have severe reductions in their liver function; if given with ritonavir it must not be used in patients with moderate reduction in liver function. 
Zdravila Reyataz ne smejo uporabljati bolniki z resnim zmanjšanjem delovanja jeter, če se daje skupaj z ritonavirjem pa ga ne smejo uporabljati bolniki z zmernim zmanjšanjem delovanja jeter.
Reyataz is an antiviral medicine that contains the active substance atazanavir. 
Zdravilo Reyataz je protivirusno zdravilo, ki vsebuje zdravilno učinkovino atazanavir.
Reyataz oral powder can be used for children aged at least 3 months and weighing at least 5 kg, and for patients who cannot swallow capsules. 
Reyataz se lahko uporablja pri otrocih, starih najmanj tri mesece in s telesno maso najmanj pet kg ter pri bolnikih, ki ne morejo pogoltniti kapsul.
It compared continued treatment with either a higher dose of Reyataz without ritonavir or the boosted combination. 
Neprekinjeno zdravljenje so primerjali bodisi z zdravilom Reyataz brez ritonavirja bodisi z okrepljeno kombinacijo.
In the two studies in children aged from 3 months up to 11 years taking boosted Reyataz oral powder, the viral load was undetectable in about half the children after treatment for 48 weeks. 
V dveh študijah pri otrocih, starih od 3 mesece do 11 let; ki so jemali okrepljeni peroralni prašek zdravila Reyataz, je bilo virusno breme nezaznavno pri približno polovici otrok po 48-tedenskem zdravljenju.
Reyataz capsules boosted with ritonavir have also been studied in 41 patients aged between 6 and 18 years. 
Zdravilo Reyataz v kapsulah, okrepljeno z ritonavirjem, so proučevali tudi pri 41 bolnikih, starih od 6 do 18 let.
Treatment with Reyataz should be started by a doctor who has experience in the treatment of HIV infection. 
Zdravljenje z zdravilom Reyataz lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
In the study in patients who already had undetectable viral loads with ritonavir-boosted Reyataz capsules, these were maintained in 68 of 87 patients (78%) who continued treatment with a higher dose of Reyataz without ritonavir, and in 64 of 85 (75%) who continued with the boosted combination. 
V študiji pri bolnikih, ki so že imeli nezaznavno raven virusnega bremena z zdravilom Reyataz v kapsulah, okrepljenim z ritonavirjem, se je ta ohranila pri 78 % (68 od 87) bolnikov, ki so nadaljevali zdravljenje z večjim odmerkom zdravila Reyataz brez ritonavirja, in pri 75 % (64 od 85) tistih, ki so nadaljevali z zdravljenjem z okrepljeno kombinacijo.
The active substance in Reyataz, atazanavir, is a protease inhibitor. 
Zdravilna učinkovina zdravila Reyataz, atazanavir, je zaviralec proteaze.
Other information about Reyataz: 
Druge informacije o zdravilu Reyataz:
Why has Reyataz been approved? 
Zakaj je bilo zdravilo Reyataz odobreno?
Reyataz oral powder with ritonavir has been assessed in two main studies involving 155 children aged from 3 months up to 11 years. 
Peroralni prašek zdravila Reyataz z ritonavirjem so ocenjevali v dveh glavnih študijah pri 155 otrocih starih od 3 mesece do 11 let.
For patients who have received HIV medicines before, doctors should prescribe Reyataz only after they have looked at which medicines the patient has taken and carried out tests to establish that the virus is likely to respond to Reyataz. 
Zdravniki lahko predpišejo zdravilo Reyataz bolnikom, ki so že jemali druga zdravila za zdravljenje okužbe z virusom HIV šele po tem, ko preverijo, katera zdravila je bolnik jemal prej in ko opravijo preiskave za ugotovitev verjetnosti, da se bo virus odzval na to zdravilo.
In the patients aged between 6 and 18 years, 81% of those who had not taken HIV treatment in the past (13 out of 16) and 24% of those who had taken it in the past (6 out of 25) had viral loads below 50 copies/ml after 48 weeks. 
Pri bolnikih, starih od 6 do 18 let, je 81 % (13 od 16) tistih, ki se še niso zdravili zaradi okužbe z virusom HIV, in 24 % (6 od 25) tistih, ki so se proti njej že zdravili, po 48 tednih imelo virusno breme pod 50 kopij/ml.
In patients who had not been treated before, ritonavir-boosted Reyataz capsules were as effective as ritonavir-boosted lopinavir. 
Pri bolnikih, ki predhodno še niso bili zdravljeni, je bilo z ritonavirjem okrepljeno zdravilo Reyataz v kapsulah enako učinkovito kot z ritonavirjem okrepljen lopinavir.
At the start of the study, the patients' viral loads were around 88,100 copies/ml, but after 48 weeks, 78% of the patients taking Reyataz (343 out of 440) had viral loads below 50 copies/ml, compared with 76% of those taking lopinavir (338 out of 443). 
Na začetku študije je bilo virusno breme pri bolnikih okoli 88 100 kopij/ml, po 48 tednih pa je bilo pri 78 % (343 od 400) bolnikov, ki so jemali zdravilo Reyataz nižje od 50 kopij/ml v primerjavi s 76 % (338 od 443) tistih, ki so jemali lopinavir.
Reyataz capsules have been assessed in four main studies involving patients aged 16 years and over. 
Zdravilo Reyataz so proučevali v štirih glavnih študijah, v katere so bili vključeni bolniki, starejši od 16 let.
For the full list of all side effects reported with Reyataz, see the package leaflet. 
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Reyataz, glejte navodilo za uporabo.
In the third study, patients taking ritonavir-boosted Reyataz capsules had similar falls in viral load after 24 and 48 weeks as those taking ritonavir-boosted lopinavir: they had fallen by around 99% after 48 weeks. 
V tretji študiji so imeli bolniki, ki so jemali z ritonavirjem okrepljeno zdravilo Reyataz, po 24 oziroma 48 tednih podobno znižanje virusnega bremena kot bolniki, ki so jemali z ritonavirjem okrepljen lopinavir: po 48 tednih se je zmanjšalo za približno 99 %.
In the second study, ritonavir-boosted lopinavir caused a greater reduction in viral load than Reyataz capsules taken without ritonavir after 24 weeks. 
V drugi študiji je z ritonavirjem okrepljeni lopinavir po 24 tednih povzročil večje zmanjšanje virusnega bremena kot zdravilo Reyataz, jemano brez ritonavirja.
What is Reyataz used for? 
Za kaj se zdravilo Reyataz uporablja?
How does Reyataz work? 
Kako zdravilo Reyataz deluje?
A further main study involved 172 patients who had achieved undetectable viral load (below 50 copies/ml) after treatment with Reyataz capsules and ritonavir. 
V nadaljnjo glavno študijo je bilo vključenih 172 bolnikov, ki so po zdravljenju z zdravilom Reyataz in ritonavirjem imeli nezaznavno raven virusnega bremena (pod 50 kopij na mililiter krvi).
How is Reyataz used? 
Kako se zdravilo Reyataz uporablja?
What is Reyataz? 
Kaj je zdravilo Reyataz?
For the full list of restrictions with Reyataz see the package leaflet. 
Za celoten seznam omejitev pri uporabi zdravila Reyataz glejte navodilo za uporabo.
The final study compared Reyataz plus either ritonavir or saquinavir with ritonavir-boosted lopinavir in 358 patients. 
V zadnji študiji so pri 358 bolnikih zdravilo Reyataz v kombinaciji z ritonavirjem ali sakvinavirjem primerjali z lopinavirjem, okrepljenim z ritonavirjem.
The other three studies involved a total of 743 patients who had taken treatment for HIV infection before: the first two compared Reyataz, taken with saquinavir (another antiviral medicine) but without ritonavir, with ritonavir-boosted saquinavir or ritonavir-boosted lopinavir. 
V prvih dveh študijah so zdravilo Reyataz v kombinaciji s sakvinavirjem (drugim protivirusnim zdravilom) vendar brez ritonavirja primerjali s sakvinavirjem, okrepljenim z ritonavirjem, ali z lopinavirjem, okrepljenim z ritonavirjem.
How has Reyataz been studied? 
Kako je bilo zdravilo Reyataz raziskano?
One study compared ritonavir-boosted Reyataz with ritonavir-boosted lopinavir (another antiviral medicine) in 883 patients who had not taken treatment for HIV infection before. 
V eni študiji so pri 883 bolnikih, ki predhodno še niso bili zdravljeni zaradi okužbe z virusom HIV, z ritonavirjem okrepljeno zdravilo Reyataz primerjali z lopinavirjem (drugim protivirusnim zdravilom), okrepljenim z ritonavirjem.
The CHMP considered that Reyataz's effectiveness had been shown in patients aged at least 3 months and weighing at least 5 kg. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da je bila učinkovitost zdravila Reyataz dokazana pri bolnikih, starih najmanj tri mesece in s telesno maso najmanj pet kg. Zaključil je, da so koristi zdravila Reyataz večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Neonates and children 
Novorojenčki in otroci
A statement on the emergence of resistant organisms was inserted. 
Dodana je bila izjava o pojavu odpornih organizmov.
“Children 2 to 12 years of age - Complicated intra-abdominal infections 
„Otroci, stari od 2 do 12 let - Zapletene intraabdominalne okužbe
Septicaemia, bacteraemia 
Septikemija, bakteriemija
After the initial assessment, a number of lists of outstanding issues were discussed. 
Po prvotnem vrednotenju je odbor razpravljal o številnih nerešenih vprašanjih.
Overall summary of the scientific evaluation of Tazocin and associated names (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Tazocin in povezanih imen (glejte Prilogo I)
Indications have to be infection (site) specific. 
Indikacije morajo biti specifične za (mesto) okužbe.
For all indications, differences in clinical practices and national treatment recommendations are addressed by the sentence “Consideration should be given to official guidance on the appropriate use of antibiotics.” 
Pri vseh indikacijah so razlike v kliničnih praksah in nacionalnih priporočilih za zdravljenje obravnavane s stavkom „Upoštevati je treba uradne smernice o ustrezni rabi antibiotikov“.
Regarding adult and adolescent patients (> 12 years of age), the dosage depends on the severity, location of the infection and the indication. 
Pri odraslih bolnikih in mladostnikih (>12 let starosti) je odmerjanje odvisno od resnosti okužbe, mesta okužbe in indikacije.
Infections in Neutropenic Patients 
Okužbe pri nevtropeničnih bolnikih
Module 2 (QOS) was also updated in line with Module 3. 
V skladu z modulom 3 je bil posodobljen tudi Modul 2 (QOS).
“Complicated intra-abdominal infections” 
„Zapletene intraabdominalne okužbe“
Where an agent may be used in certain patient subpopulations (e.g. immunocompromised patients), it is still required that indications should be as specific as possible based on the available data. 
Če naj se zdravilo uporabi za določene podskupine bolnikov (npr. imunsko kompromitirane bolnike), morajo biti indikacije kolikor je mogoče specifične glede na razpoložljive podatke.
The pooled analysis included patients with positive blood cultures however none of the studies had prospectively defined these patients and therefore it is very likely that most of these patients would not satisfy the criteria for sepsis. 
V združeni analizi so bili vključeni bolniki s pozitivnimi hemokulturami, vendar v nobeni študiji niso prospektivno opredeliti teh bolnikov, zato je zelo verjetno, da večina teh bolnikov ne bi ustrezala merilom za sepso.
However, the wording proposed by the MAH was not in line with the common European terminology or with the wording used in several recently finalised procedures for generics. 
Vendar besedilo, ki ga je predlagal imetnik dovoljenja za promet z zdravilom ni bilo v skladu s skupno evropsko terminologijo ali besedilom v več nedavno končanih postopkih za generična zdravila.
The MAH stated that the contents of the section ‘4.6 Pregnancy and lactation' were the same in all countries although the wording used was slightly different. 
Imetnik dovoljenja za promet z zdravilom je navedel, da je bila vsebina poglavja „4.6 Nosečnost in dojenje“ enaka v vseh državah, čeprav je bilo besedilo nekoliko različno.
Regarding children aged 2-12 years with normal renal function, the CHMP agreed to a dosage of 80/10 mg/kg every 6 hours for neutropenic children and 100/12.5 mg/kg every 8 hours for complicated intra-abdominal infections. 
Pri otrocih, starih od 2 do 12 let, z normalnim delovanjem ledvic se je strinjal z odmerjanjem 80/10 mg/kg vsakih 6 ur za nevtropenične otroke in 100/12,5 mg/kg vsakih 8 ur za zapletene intraabdominalne okužbe.
The CHMP noted the data submitted. 
CHMP je upošteval predložene podatke.
The CHMP assessed the data submitted but noted that the comparative studies were all performed at the initial US-approved regimen of 3.375 g every 6 hours. 
CHMP je ovrednotil predložene podatke in ugotovil, da so bile vse primerjalne študije opravljene z odmerkom 3,375 g vsakih 6 ur, ki je bil prvotno odobren v ZDA.
A CHMP drafting group was convened on two occasions. 
Skupina za osnutke CHMP se je sešla na dveh sejah.
As already stated, piperacillintazobactam should be preserved for situations where a broad-spectrum agent really is required, i.e. not for the treatment of non-severe infections. 
Kot je bilo že omenjeno, je treba piperacilin - tazobaktam ohraniti za primere, ko je širokospektralno zdravilo zares potrebno, tj. ne za zdravljenje blažjih okužb.
The CHMP therefore deleted the indication. 
Zato je CHMP indikacijo izbrisal.
Infections caused by bacteria with higher MIC values will require more frequent dosing, while more sensitive bacteria may be adequately treated with less frequent dosing. 
Okužbe, ki jih povzročijo bakterije z višjimi vrednostmi MIK, zahtevajo pogostejše odmerjanje, občutljivejše bakterije pa se lahko zadostno zdravijo z manj pogostim odmerjanjem.
Specific indications are discussed below by site of infection. 
Razprava o specifičnih indikacijah je v nadaljevanju razdeljena po mestih okužbe.
The CHMP revised the wording of the indication to reflect the study population in the pivotal study and current practice and brought it in line with the indication in adults. 
CHMP je spremenil besedilo indikacije, da odraža proučevano populacijo v ključni študiji in trenutno prakso, ter jo uskladil z indikacijo pri odraslih.
The CHMP noted that the supporting evidence is mainly derived from studies in febrile neutropenia and that only about a quarter of patients across different trials had “bacteraemia”. 
CHMP je ugotovil, da podporni dokazi v glavnem izvirajo iz študij febrilne nevtropenije in da je v raznih preskušanjih le približno četrtina bolnikov imela „bakteriemijo“.
Tazocin was included in the list of products for Summary of Product Characteristics (SPC) harmonisation, due to the divergent national decisions taken by Member States concerning the authorisation of the product. 
Zdravilo Tazocin je bilo vključeno na seznam za usklajevanje povzetkov glavnih značilnosti zdravila zaradi različnih nacionalnih odločitev držav članic glede odobritve zdravila.
"Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above". 
„Zdravljenje bolnikov z bakteriemijo, ki se pojavi v povezavi s katero koli od zgoraj navedenih okužb ali ob sumu povezave z njimi“.
The CHMP agreed on a statement that the usual duration of treatment for most indications is in the range of 5-14 days but that the duration of treatment should be guided by the severity of the infection, the pathogen(s) and the patient's clinical and bacteriological progress. 
CHMP se je strinjal z izjavo, da je običajno trajanje zdravljenja večine indikacij v razponu od 5 do 14 dni, vendar mora biti pri trajanju zdravljenja vodilo resnost okužbe, povzročitelj(i) in bolnikovo klinično in bakteriološko napredovanje.
Similarly, the clinical and pharmacokinetic data from comparative studies in adults and children, as well as wide clinical experience in children aged > 2 years, support the safety and efficacy in the treatment of intra-abdominal infections in paediatric patients. 
Podobno, klinični in farmakokinetični podatki iz primerjalnih študij pri odraslih in otrocih ter obsežne klinične izkušnje pri otrocih, starejših od 2 let, podpirajo varnost in učinkovitost pri zdravljenju intraabdominalnih okužb pri pediatričnih bolnikih.
As clinical data in children are very sparse and will mainly have to be derived by extrapolation from the adult population, the acceptance of indications in this population will be influenced by the indications accepted for the adult population. 
Ker je kliničnih podatkov o otrocih zelo malo in se večinoma ekstrapolirajo iz populacije odraslih bolnikov, bodo na sprejem indikacij v tej populaciji vplivale indikacije, sprejete za populacijo odraslih bolnikov.
The CHMP revised the MAH proposal to bring it in line with the current guidelines and considered that the available evidence sufficiently supports the use of Tazocin 4.5 g every 8 hours for this indication. 
CHMP je popravil predlog imetnika dovoljenja za promet z zdravilom in ga uskladil s trenutnimi smernicami ter menil, da so razpoložljivi podatki zadostni za podporo uporabi zdravila Tazocin 4,5 g vsakih 8 ur za to indikacijo.
These studies used a number of different regimens of Tazocin and a variety of comparators, each administered with or without an aminoglycoside in different studies. 
V teh študijah so uporabili številne različne režime zdravljenja z zdravilom Tazocin in različna primerjalna zdravila, pri čemer so v različnih študijah vsakega uporabili zdravilo z aminoglikozidom ali brez njega.
This is why the drug should not be used in less severe infections, where more appropriate alternatives are available and instead be used in severely ill patients for cases of CAP that require hospitalisation. 
Zdravila se zato ne sme uporabljati za blažje okužbe, za katere so na voljo primernejša alternativna zdravila, ampak samo za hudo bolne bolnike v primerih izvenbolnišnično pridobljene pljučnice, za katere je potrebna hospitalizacija.
“Complicated skin and soft tissue infections (including diabetic foot infections)” 
„Zapletene okužbe kože in mehkih tkiv (vključno z okužbami diabetičnega stopala)“
The CHMP agreed on a dosage of 4 g piperacillin/0.5 g tazobactam given every 6 to 8 hours. 
CHMP se je strinjal glede odmerjanja 4 g piperacilina/0,5 g tazobaktama, ki se dajeta vsakih 6 do 8 ur.
The CHMP agreed with the MAH proposals and adopted harmonised wordings for Section 6.1 - List of excipients, Section 6.2 Incompatibilities, Section 6.3 Shelf life, Section 6.4 - Special precautions for storage, Section 6.5 - Nature and contents of container and Section 6.6 - Special precautions for disposal and other handling. 
CHMP se je strinjal s predlogi imetnika dovoljenja za promet z zdravilom in sprejel usklajeno besedilo poglavja 6.1 - Seznam pomožnih snovi, poglavja 6.2 - Inkompatibilnosti, poglavja 6.3 - Rok uporabnosti, poglavja 6.4 - Posebna navodila za shranjevanje, poglavja 6.5 - Vrsta ovojnine in vsebina ter poglavja 6.6 - Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom.
The CHMP decided to remove the triple combination (intramuscular administration with lidocaine) from the scope of the procedure, in line with the notification. 
CHMP se je v skladu z obvestilom odločil umakniti trojno kombinacijo (intramuskularna uporabo z lidokainom) iz obsega postopka.