natgillin/translations-raw huggingface dataset:
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 25/04/2016 (Invokana, Jardiance) and 28/04/2016 (Forxiga, XigDuo, Synjardy, Vokanamet). 
Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je dne 25. aprila 2016 (Invokana, Jardiance) in 28. aprila 2016 (Forxiga, XigDuo, Synjardy, Vokanamet) izdala končno pravno zavezujočo odločbo, ki velja za vse države članice EU.
On 25 February 2016, the European Medicines Agency (EMA) confirmed recommendations1 to minimise the risk of diabetic ketoacidosis in patients taking SGLT2 inhibitors (a class of type 2 diabetes medicines). 
Evropska agencija za zdravila (EMA) je 25. februarja 2016 potrdila priporočila1 za zmanjševanje tveganja diabetične ketoacidoze pri bolnikih, ki jemljejo zaviralce SGLT2 (razred zdravil za zdravljenje sladkorne bolezni tipa 2).
The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), which confirmed them and adopted the Agency's final opinion. 
Priporočila odbora PRAC so bila poslana Odboru za zdravila za uporabo v humani medicini (CHMP), ki jih je potrdil in sprejel končno mnenje agencije.
By blocking the action of SGLT2, these medicines cause more glucose to be removed through the urine, thereby reducing the levels of glucose in the blood. 
Ta zdravila z zaviranjem delovanja SGLT2 povzročijo večje izločanje glukoze z urinom in s tem zmanjšajo raven glukoze v krvi.
The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations. 
Pregled je najprej opravil Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj o zdravilih za uporabo v humani medicini, in podal več priporočil.
Healthcare professionals should therefore consider the possibility of ketoacidosis in patients taking SGLT2 inhibitors who have symptoms consistent with the condition even if blood sugar levels are not high. 
Zdravstveni delavci morajo zato pomisliti na možnost diabetične ketociadoze pri bolnikih, ki jemljejo zaviralce SGLT2 in imajo simptome, ki ustrezajo tej bolezni, tudi če ravni krvnega sladkorja pri njih niso visoke.
They block a protein in the kidneys called SGLT2, which absorbs glucose back from the urine into the bloodstream as the blood is filtered in the kidneys. 
Zavirajo beljakovino v ledvicah, imenovano SGLT2, ki pri filtraciji krvi v ledvicah ponovno absorbira glukozo iz urina v krvni obtok.
A number of these cases were atypical with patients having only moderately raised blood sugar levels and some of them occurred during offlabel use and clinical trials in patients with type 1 diabetes. 
Številni od teh primerov so bili atipični, saj so imeli bolniki le zmerno zvišano raven krvnega sladkorja, nekateri primeri pa so se pojavili pri uporabi, ki ni v skladu z odobrenimi indikacijami, in kliničnem preizkušanju pri bolnikih s sladkorno boleznijo tipa 1.
If diabetic ketoacidosis is suspected or confirmed, treatment with SGLT2 inhibitors should be stopped immediately and should not be re-started unless another cause for the ketoacidosis is identified and resolved. 
Če obstaja sum na diabetično ketoacidozo oziroma je ta potrjena, je treba zdravljenje z zaviralci SGLT2 takoj prekiniti in se ne sme ponovno uvesti, razen če se ugotovi in odpravi drug sprožilni dejavnik za ketoacidozo.
Following a review of the cases, EMA recommended updating the product information of SGLT2 inhibitors to list diabetic ketoacidosis as a rare adverse reaction (affecting up to 1 in 1,000 patients). 
Po pregledu primerov je agencija EMA za zaviralce SGLT2 priporočila posodobitev informacij o zdravilu, tako da bi bila diabetična ketoacidoza navedena kot redek neželeni učinek (ki prizadene največ 1 bolnika od 1 000).
Healthcare professionals should exercise caution with SGLT2 inhibitors in patients with risk factors for ketoacidosis and inform patients of these factors. 
Zdravstveni delavci naj zaviralce SGLT2 pri bolnikih z dejavniki tveganja za ketoacidozo uporabljajo previdno in bolnike o teh dejavnikih poučijo.
These include low reserve of insulin-secreting cells, a sudden reduction in insulin dose, an increased requirement for insulin (due to illness, surgery or alcohol abuse) and conditions that restrict food intake or can lead to severe dehydration. 
Mednje spadajo majhna rezerva celic, ki izločajo insulin, nenadno zmanjšanje odmerka insulina, povečana potreba po insulinu (zaradi bolezni, kirurškega posega ali čezmernega uživanja alkohola) in stanja, ki omejijo uživanje hrane ali lahko vodijo v hudo dehidracijo.
• Stop treatment with SGLT2 inhibitors temporarily in patients undergoing major surgical procedures or hospitalised due to acute serious medical illnesses. 
• Zdravljenje z zaviralci SGLT2 začasno prekinite tudi pri bolnikih, ki so imeli večji kirurški poseg ali so bili hospitalizirani zaradi hude akutne bolezni.
• Healthcare professionals are reminded that SGLT2 inhibitors are only authorised for treating type 2 diabetes. 
• Zdravstvene delavce opominjamo, da so zaviralci SGLT2 odobreni le za zdravljenje sladkorne bolezni tipa 2.
In addition, EMA recommended temporarily stopping SGLT2 inhibitors in patients who are undergoing major surgery or are in hospital due to serious illness. 
Poleg tega je agencija EMA priporočila začasno prenehanje uporabe zaviralcev SGLT2 pri bolnikih, ki so imeli večje kirurške posege ali so zaradi bolezni hospitalizirani.
• Exercise caution in patients with risk factors for ketoacidosis and inform patients of these factors. 
• Pri bolnikih z dejavniki tveganja za ketoacidozo bodite previdni in jih poučite o teh dejavnikih.
Finally, EMA reminded healthcare professionals that SGLT2 inhibitors are not authorised for type 1 diabetes, noting that cases of ketoacidosis have also occurred during off-label use and clinical trials in type 1 diabetes. 
Agencija EMA je tudi opomnila zdravstvene delavce, da zaviralci SGLT2 niso odobreni za sladkorno bolezen tipa 1, saj so se primeri ketoacidoze pojavili tudi ob uporabi, ki ni v skladu z odobrenimi indikacijami, in kliničnih preizkušanjih pri sladkorni bolezni tipa 1.
Sodium-glucose co-transporter-2 (SGLT2) inhibitors are medicines used to treat type 2 diabetes. 
Zaviralci natrijevih glukoznih koprenašalcev 2 (SGLT2) so zdravila, ki se uporabljajo za zdravljenje sladkorne bolezni tipa 2.
Patients taking these medicines should be aware of the symptoms of diabetic ketoacidosis, including rapid weight loss, nausea or vomiting, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat. 
Bolniki, ki jemljejo ta zdravila, morajo poznati simptome diabetične ketoacidoze, vključno s hitro izgubo telesne mase, navzejo ali bruhanjem, bolečinami v trebuhu, čezmerno žejo, hitrim in plitvim dihanjem, zmedenostjo, nenavadno zaspanostjo ali utrujenostjo, sladkim zadahom, sladkim ali kovinskim okusom v ustih in spremenjenim vonjem urina ali znoja.
Symptoms include rapid weight loss, nausea or vomiting, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat. 
Simptomi vključujejo hitro izgubo telesne mase, navzejo ali bruhanje, bolečino v trebuhu, čezmerno žejo, hitro in plitvo dihanje, zmedenost, nenavadno zaspanost ali utrujenost, sladek zadah, sladek ali kovinski okus v ustih in spremenjen vonj urina ali znoja.
The benefits of these medicines continue to outweigh the risks in the treatment of type 2 diabetes. 
Pri zdravljenju sladkorne bolezni tipa 2 koristi teh zdravil še vedno odtehtajo tveganja.
• Stop treatment with SGLT2 inhibitors immediately if diabetic ketoacidosis is suspected or confirmed, and do not re-start treatment unless another clear precipitating factor for the condition is identified and resolved. 
• Če obstaja sum na diabetično ketoacidozo oziroma je ta potrjena, je treba zdravljenje z zaviralci SGLT2 takoj prekiniti in se ne sme ponovno uvesti, razen če se ugotovi in odpravi drug sprožilen dejavnik za ketoacidozo.
• Some of the cases of diabetic ketoacidosis in people taking SGLT2 inhibitors did not show the very high sugar levels normally associated with this condition. 
• V nekaterih primerih diabetične ketoacidoze pri ljudeh, ki jemljejo zaviralce SGLT2, raven krvnega sladkorja ni bila zelo visoka, kot je sicer značilno za to stanje.
Patients should contact a doctor or the nearest hospital straightaway if they have any of these symptoms. 
Če imajo bolniki katerega od teh simptomov, naj se takoj posvetujejo z zdravnikom ali najbližjo bolnišnico.
• Always consider the possibility of diabetic ketoacidosis in patients taking SGLT2 inhibitors who have non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness. 
• Pri bolnikih, ki jemljejo zaviralce SGLT2 in imajo neizrazite simptome, kot so navzeja, bruhanje, anoreksija, bolečine v trebuhu, čezmerna žeja, težave z dihanjem, zmedenost, nenavadna utrujenost ali zaspanost, vedno pomislite na možnost diabetične ketoacidoze.
• Rare cases of diabetic ketoacidosis, including life-threatening ones, have occurred in patients taking SGLT2 inhibitors, used to treat type 2 diabetes. 
Redki primeri tega stanja, vključno z življenjsko nevarnimi, so se pojavili pri bolnikih, ki za zdravljenje sladkorne bolezni tipa 2 jemljejo zaviralce SGLT2.
• Rare cases of diabetic ketoacidosis have occurred in people with type 2 diabetes taking diabetes medicines known as SGLT2 inhibitors. 
• Pri bolnikih s sladkorno boleznijo tipa 2, ki so jemali zdravila za sladkorno bolezen, znana kot zaviralci SGLT2, so se pojavili redki primeri diabetične ketoacidoze.
These include low insulin-producing capacity in the pancreas, a sudden drop in a patient's insulin dose, increased insulin requirement (due to illness, surgery or alcohol abuse) or conditions that can restrict food intake or lead to severe dehydration. 
Ti dejavniki so nizka sposobnost trebušne slinavke za tvorbo insulina, nenaden upad bolnikovega odmerka insulina, povečana potreba po insulinu (zaradi
• All unused devices or empty containers should be returned systematically according to the local regulation. 
• Vse neuporabljene pripomočke in prazne vsebnike je treba sistematično vrniti v skladu z nacionalnim predpisom.
• The pharmacist must make use of the checklist for pharmacist 
• farmacevt mora uporabljati kontrolni seznam za farmacevta.
Prior to launch in each member State the MAH shall agree the final educational material with the National Competent Authority. 
Pred prihodom zdravila na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom dogovoriti s pristojnim državnim organom za končno obliko izobraževalnega gradiva.
• The pharmacist must be familiar with the educational material of PecFent nasal spray before using it in his/her organization 
• farmacevt mora natančno poznati izobraževalno gradivo o pršilu za nos PecFent, preden ga začne uporabljati v svoji organizaciji;
The MAH shall ensure that, at launch, all physicians, pharmacists and patients expected to prescribe/use PecFent are provided with educational material informing about the correct and safe use of the product. 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo ob prihodu zdravila na trg vse zdravnike, farmacevte in bolnike, za katere pričakuje, da bodo predpisovali/uporabljali zdravilo PecFent, oskrbel z izobraževalnim gradivom, ki bo nudilo informacije o pravilni in varni uporabi zdravila.
• The pharmacist must inform the patients that in order to prevent theft and misuse of PecFent nasal spray they have to keep it in a safe place to avoid misuse and diversion 
• farmacevt mora obvestiti bolnike, da morajo zaradi preprečevanja kraje in zlorabe pršila nos PecFent to zdravilo hraniti na varnem mestu, da preprečijo zlorabo in krajo;
• Do not use PecFent nasal spray to treat any other short-term pain or pain status 
• ne uporabljajte pršila za nos PecFent za zdravljenje kakšne druge kratkoročne bolečine ali bolečinskega stanja;
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: 
Države članice morajo zagotoviti, da bodo izpolnjeni vsi pogoji ali uveljavljene vse omejitve v zvezi z varno in učinkovito uporabo zdravila, opisane v nadaljevanju:
• The prescribers of PecFent nasal spray must critically select the patients and closely follow o Instructions for use of the nasal spray device o Instructions for opening and closing of the child-resistant box o Information on the correct indication 
• Zdravniki, ki predpisujejo pršilo za nos PecFent, morajo izbirati bolnike po strogih merilih in se natančno ravnati po o navodilih za uporabo pripomočka za razprševanje v nos; o navodilih za odpiranje in zapiranje škatle, varne za otroke; o informacijah o pravilni indikaciji.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES 
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI NAJ JIH IZPOLNIJO ALI UVELJAVIJO DRŽAVE ČLANICE
• PecFent nasal spray is only indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain 
• pršilo za nos PecFent je indicirano le za zdravljenje prebojne bolečine pri odraslih, ki že prejemajo vzdrževalno opioidno zdravljenje za kronično bolečino zaradi raka;
• Do not use PecFent nasal spray for treatment of more than four breakthrough cancer pain episodes a day 
• ne uporabljajte pršila za nos PecFent za zdravljenje več kot štirih epizod prebijajoče bolečine zaradi raka na dan;
• Only use PecFent nasal spray if you have been experiencing breakthrough cancer pain episodes 
• pršilo za nos PecFent uporabljajte le, če doživljate epizode prebojne bolečine zaradi raka;
1 pre-filled syringe 
1 napolnjena injekcijska brizga viala (steklo)
It was therefore suggested to change the content of the paragraph accordingly. 
Zato je bilo predlagano, da se vsebina odstavka ustrezno spremeni.
Therefore, a statement should be added on the use in adolescents and adults. 
Zato je treba dodati navedbo o uporabi pri mladostnikih in odraslih.
The pharmaceutical form and strength is identical in all countries. 
Farmacevtska oblika in jakost sta v vseh državah enaki.
Subjects with immune deficiencies 
Bolniki z imunskimi pomanjkljivostmi
The intramuscular route of administration is approved in all Member States except The Netherlands. 
Intramuskularni način dajanja je odobren v vseh državah članicah, razen na Nizozemskem.
This might need to be reviewed for all concerned products. 
Morda bo potrebna revizija za vsa zadevna zdravila.
In the past decade, several mumps outbreaks have been reported in highly vaccinated populations (two doses). 
V preteklem desetletju so poročali o številnih izbruhih mumpsa pri dobro cepljeni populaciji (dva odmerka).
Vaccine efficacy data should differentiate between one or two doses. 
Podatki o učinkovitosti cepiva pri enem ali dveh odmerkih naj bodo ločeni.
Overall summary of the scientific evaluation of Priorix and associated names (see annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Priorix in povezanih imen (glejte Prilogo I)
Although there are only limited data, it was noted that intramuscular administration is standard practice in many Member States. 
Čeprav podatkov ni veliko, je bilo ugotovljeno, da je v številnih državah članicah intramuskularno dajanje standardna praksa.
During the CHMP discussion it was questioned whether “pregnancy” should continue to be stated under contraindications. 
Med razpravo v okviru CHMP se je pojavilo vprašanje, ali naj bo „nosečnost“ še naprej navedena med kontraindikacijami.
Some vaccines that can be co-administered with Priorix are listed in the SmPC of Belgium, Bulgaria, Cyprus, Denmark, Estonia, France, Luxemburg, Malta, The Netherlands, Poland, Romania and United Kingdom. 
Nekatera cepiva, ki jih je mogoče uporabiti sočasno, so navedena v povzetku glavnih značilnosti zdravila za Belgijo, Bolgarijo, Ciper, Dansko, Estonijo, Francijo, Luksemburg, Malto, Nizozemsko, Poljsko, Romunijo in Združeno kraljestvo.
In addition, the product information (PI) was presented using the latest version of the QRD template, version 2, published on 12 October 2011. 
Predložene so bile tudi informacije o zdravilu v obliki zadnje različice predloge QRD, različice 2, objavljene 12. oktobra 2011.
Section 4.6 - Fertility, pregnancy and lactation Fertility 
Poglavje 4.6 - Plodnost, nosečnost in dojenje Plodnost
In addition it was stated that the advice on breastfeeding should be clearer with respect to the different recommendations for vaccinating mothers with children with or without immunodeficiency. 
Poleg tega je bilo navedeno, da mora biti nasvet o dojenju bolj jasen glede različnih priporočil za cepljeno mater pri otroku z imunsko pomanjkljivostjo ali brez nje.
As regards HIV, there is no common European guidance on the CD4+ classification for % CD4+ or the cell count number. 
Za HIV ni skupnih evropskih smernic o razvrstitvi CD4+ po odstotkih CD4+ ali po številu celic.
As Priorix is contraindicated in pregnant women neither interventional nor active surveillance activities have been set up. 
Ker je cepivo Priorix pri nosečnicah kontraindicirano, niso bile vzpostavljene ne intervencijske ne aktivne dejavnosti spremljanja.
A seropositive response by ELISA may not necessarily represent protection, especially for mumps. 
Seropozitivni odziv, dosežen s testom ELISA, ne pomeni nujno zaščite, zlasti ne za mumps.
Even if vaccine virus is transmitted, the infection is mild and self-limiting (ACIP 2011). 
Tudi če se virus cepiva prenese, je okužba blaga in samoomejujoča (ACIP 2011).
The approved lower age limit indicated for the use of Priorix varied from 9 months to 15 months across the individual EU member states reflecting in some cases the national recommendations for routine MMR vaccination. 
Odobrena spodnja starostna meja, indicirana za uporabo cepiva Priorix, se razlikuje po posameznih državah članicah EU, in sicer znaša od 9 do 15 mesecev, , kar v nekaterih primerih odraža nacionalna priporočila za rutinska cepljenja proti MMR.
The incidence rates among the cases in both these age categories were above 50 and 45 cases per 100,000 respectively. 
Stopnji obolevnosti v obeh starostnih kategorijah sta bili v prvem primeru več kot 50 in v drugem več kot 45 primerov na 100 000 oseb.
This justification was accepted by the CHMP. 
Odbor CHMP je utemeljitev sprejel.
The immunogenicity of Priorix was evaluated in several clinical trials in children aged from 12 to 24 months, 11 to 23 months and 9 to 12 months. 
Imunogenost cepiva Priorix je bila ocenjena v več kliničnih preskušanjih pri otrocih, starih od 12 do 24 mesecev, od 11 do 23 mesecev in od 9 do 12 mesecev.
reduce a long paragraph about the use of epinephrine by a general statement about the availability of appropriate medical treatment and supervision following the administration of the vaccine. 
skrajšanje dolgega odstavka o uporabi epinefrina in vključitev splošne navedbe o razpoložljivosti ustreznega medicinskega zdravljenja in nadzoru po cepljenju,
However, it was noted by the MAH that the data are very limited considering the contraindication currently in the label. 
Vendar pa so opazili, da so podatki imetnika dovoljenja za promet z zdravilom zelo omejeni glede na kontraindikacije, ki so trenutno na oznaki.
However, it was considered necessary to include age specific %CD4+ as per WHO guidance since vaccination of children from the age of 9 months onwards is indicated. 
Vendar pa meni, da je treba vključiti starostno specifični odstotek CD4+ v skladu s smernico SZO, saj je indicirano cepljenje otrok od starosti 9 mesecev naprej.
The CHMP agreed that the dosing recommendations are acceptable, however in order to provide clear instructions to health care professionals a more structured wording was proposed (i.e. to split the recommendations per age group). 
CHMP se strinja, da so priporočila za odmerjanje sprejemljiva, vendar je bilo zaradi večje jasnosti navodil za zdravstveno osebje predlagano bolj strukturirano besedilo (tj. ločena priporočila za vsako starostno skupino).
Moreover the antibody response to measles vaccine decreases as the level of immunosuppression increases. 
Tudi odziv protiteles na cepivo proti ošpicam se manjša z naraščanjem ravni imunosupresije.
For this reason and to reflect the most recent information, the immunogenicity data were differentiated between two groups: “Immune response in children 12 months and older” and “Immune response in children aged 9 to 10 months”. 
Zaradi tega razloga in za prikaz najnovejših informacij so bili podatki o imunogenosti razdeljeni na dve skupini: „Imunski odziv pri otrocih, starih 12 mesecev in več“ in „Imunski odziv pri otrocih, starih 9 do 10 mesecev“.
Priorix is nationally approved in 20 countries and is approved through the mutual recognition procedure (MRP) in 9 countries. 
Cepivo Priorix je v 20 državah odobreno po nacionalnem postopku, v 9 državah pa je odobreno v okviru postopka z medsebojnim priznavanjem.
The theoretical teratogenic risk following rubella vaccination has been estimated to be 0.5% during the first trimester and is up to 1.6%, if the vaccine is given between 1-2 weeks before and 4-6 weeks after conception. 
Teoretično teratogeno tveganje po cepljenju proti rdečkam je bilo ocenjeno na 0,5 % v prvem trimesečju in znaša največ 1,6 %, če se cepivo injicira 1-2 tedna pred spočetjem in 4-6 po njem.
The available data do not suggest that co-administration of these vaccines has an impact on the immunogenicity and safety of the antigens tested. 
Razpoložljivi podatki ne kažejo, da ima sočasna uporaba teh cepiv vpliv na imunogenost in varnost preskušenih antigenov.
This was endorsed by the CHMP following review and assessment of the clinical study report that was submitted to support the coadministration of Priorix with this vaccine. 
CHMP je to odobril, ko je pregledal in ocenil poročilo klinične študije, predloženo v podporo sočasnemu dajanju cepiva Priorix s temi cepivi.
Because of the much higher likelihood of thrombocytopenia after natural infection, the benefits of vaccination most often exceed the risks of severe symptomatic thrombocytopenia caused by immunization. 
Zaradi veliko večje verjetnosti trombocitopenije po naravni okužbi so koristi cepljenja največkrat večje od tveganj hude simptomatske trombocitopenije, ki jih povzroči imunizacija.
The final agreed wording is: “Women who intend to become pregnant should be advised to delay for 1 month following PRIORIX vaccination. 
Dogovorjeno je bilo naslednje končno besedilo: „Ženskam, ki nameravajo zanositi, je treba svetovati, naj zanositev prestavijo na obdobje 1 mesec po cepljenju s cepivom PRIORIX.
The MAH was asked to add some information on this issue. 
Imetnik dovoljenja za promet z zdravilom je bil naprošen, da v zvezi s tem doda nekaj informacij.
Natural rubella infection can have a devastating impact on pregnancy, leading to foetal death, premature delivery and an array of congenital defects. 
Naravna okužba z virusom rdečk ima lahko na nosečnost poguben vpliv in povzroči smrt plodu, prezgodnji porod in vrsto prirojenih okvar.
There is currently no information to conclude that there is a teratogenic risk following vaccination with MMR vaccines however the theoretical concern remains. 
Trenutno ni informacij, po katerih bi lahko sklepali na obstoj teratogenega tveganja po cepljenju, vendar teoretični pomislek ostaja.
The MAH accepted the new text and also added a sentence on the monitoring of those patients which was endorsed by the CHMP. 
Imetnik dovoljenja za promet je novo besedilo sprejel in dodal stavek o spremljanju teh bolnikov, ki ga je CHMP vključil.