natgillin/translations-raw huggingface dataset:
If necessary, the dose of follitropin alfa can be increased by adding it as a separate medicine, with 7 to 14 days between each dose increase. 
Po potrebi se lahko odmerek folitropina alfa poveča z dodajanjem te učinkovine v ločenem zdravilu, pri čemer mora biti med vsakokratnim povečanjem odmerka od sedem do 14 dni premora.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Pergoveris's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Pergoveris večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Pergoveris. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pergoveris.
Other information about Pergoveris 
Druge informacije o zdravilu Pergoveris
The first injection must be given under direct supervision of a doctor who has experience in the treatment of fertility problems, but the patient can inject herself if she wants to, provided she has been properly trained and has access to expert advice. 
Prva injekcija se daje pod neposrednim nadzorom zdravnika, ki ima izkušnje z zdravljenjem težav s plodnostjo, zdravilo pa si lahko injicira tudi bolnica sama, če je bila za to predhodno ustrezno usposobljena in ji je na voljo strokovno svetovanje.
It must also not be used in women who have malformations of the sexual organs or fibroid tumours of the womb that would stop them from becoming pregnant. 
Prav tako se ne sme uporabljati pri ženskah z malformacijo spolnih organov ali fibroidnimi tumorji maternice, ki bi preprečili zanositev.
• enlarged ovaries or a cyst on the ovary that is not due to polycystic ovarian disease and is of unknown origin, 
• povečanje jajčnikov ali cisto jajčnika, ki ni povezana s policistično boleznijo jajčnikov in je neznanega izvora;
The company also carried out bioequivalence studies to establish whether the combined injection produced the same levels of the active substances in the body as the two medicines given separately. 
Družba je prav tako izvedla študije biološke enakovrednosti, da bi proučila, ali kombinirana injekcija ustvari enake ravni zdravilnih učinkovin v telesu kot injiciranje teh učinkovin ločeno.
The recommended starting dose is 150 International Units (IU) of follitropin alfa and 75 IU of lutropin alfa once a day, but this should be tailored to the patient's response. 
Priporočeni začetni odmerek je 150 mednarodnih enot (i.e.) folitropina alfa in 75 i.e. lutropina alfa enkrat na dan, ki pa ga je treba prilagoditi odzivu bolnice.
It is not intended to provide practical advice on how to use Pergoveris. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For further information see the package leaflet. 
Za več informacij glejte navodilo za uporabo.
• cancer of the ovary, womb or breast. 
• rak jajčnikov, maternice ali dojke.
The most common side effects reported with Pergoveris (seen in more than 1 patient in 10) are headache, ovarian cysts and injection site reactions (e.g. pain, itching, redness, bruising, swelling or irritation at the site of injection). 
Najpogostejši neželeni učinki zdravila Pergoveris (opaženi pri več kot 1 bolnici od 10) so glavobol, ciste na jajčnikih in reakcije na mestu injiciranja (npr. bolečina, srbenje, rdečina, podplutba, oteklina ali vzdraženost na mestu injiciranja).
The medicine can only be obtained with a prescription. 
Predpisovanje in izdaja zdravila je le na recept.
Pergoveris must not be used when a benefit cannot be obtained, such as in women with primary ovarian failure (when the ovaries stop working before the menopause). 
Zdravilo Pergoveris se ne sme uporabljati, če ne more prinesti koristi, kot na primer pri ženskah s primarno odpovedjo jajčnikov (ko jajčniki prenehajo delovati pred nastopom menopavze).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pergoveris have been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Pergoveris upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about treatment with Pergoveris, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Pergoveris preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
EPAR summary for the public follitropin alfa / lutropin alfa 
Povzetek EPAR za javnost folitropin alfa/lutropin alfa
Treatment can cause overstimulation of the ovaries (known as ovarian hyperstimulation syndrome, OHSS), which can lead to serious medical problems. 
Zdravljenje s tem zdravilom lahko povzroči prekomerno stimulacijo jajčnikov (znano kot sindrom hiperstimulacije jajčnikov, OHSS), ki lahko povzroči resne zdravstvene težave.
What is Pergoveris and what is it used for? 
Kaj je zdravilo Pergoveris in za kaj se uporablja?
• bleeding from the genital region whose cause is unknown, 
• ginekološke krvavitve neznanega izvora,
Why is Pergoveris approved? 
Zakaj je bilo zdravilo Pergoveris odobreno?
What benefits of Pergoveris have been shown in studies? 
Kakšne koristi je zdravilo Pergoveris izkazalo v študijah?
What are the risks associated with Pergoveris? 
Kakšna tveganja so povezana z zdravilom Pergoveris?
For practical information about using Pergoveris, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Pergoveris naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
For the full list of all side effects and restrictions with Pergoveris, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Pergoveris glejte navodilo za uporabo.
Pergoveris is injected under the skin once a day until the patient has developed a suitable follicle, as assessed using ultrasound scans and by measuring blood oestrogen levels. 
Zdravilo Pergoveris se injicira v podkožje enkrat na dan, dokler se pri bolnici ne razvije ustrezen folikel, kar se oceni z ultrazvočnim pregledom in merjenjem ravni estrogena v krvi.
Both active substances have already been authorised in the European Union (EU), follitropin alfa as GONAL-f and lutropin alfa as Luveris. 
Obe zdravilni učinkovini sta že bili odobreni v Evropski uniji (EU), folitropin alfa kot zdravilo GONAL-f, lutropin alfa pa kot zdravilo Luveris.
The full EPAR for Pergoveris 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 Pergoveris je na voljo na spletni strani agencije: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004085/human_ med_002074.jsp.
Therefore, the company presented information from studies carried out during the development of Luveris to support the use of Pergoveris. 
Zato je družba v podporo zdravilu Pergoveris predstavila podatke iz študij, izvedenih v času razvoja zdravila Luveris.
• tumours of the hypothalamus or pituitary gland, 
• tumor hipotalamusa ali hipofize,
Pergoveris is a fertility medicine used in women to stimulate the development of follicles, the structures inside the ovaries that contain an egg. 
Pergoveris je zdravilo za zdravljenje plodnosti pri ženskah za stimulacijo razvoja foliklov, tj. mešičkov v jajčnikih, ki vsebujejo jajčece.
Pergoveris is available as a solution for injection in a pre-filled pen or as a powder and solvent to be made up into a solution for injection. 
Zdravilo Pergoveris je na voljo v obliki raztopine za injiciranje v napolnjenem injekcijskem peresniku ali praška in vehikla za pripravo raztopine za injiciranje.
Pergoveris is for adult women who have low levels of two hormones that stimulate the ovariesfollicle-stimulating hormone (FSH) and luteinising hormone (LH). 
Namenjeno je ženskam v odrasli dobi, ki imajo nizko raven dveh hormonov, ki stimulirata jajčnike: folikle stimulirajočega hormona (FSH) and luteinizirajočega hormona (LH).
By replacing the missing hormones, Pergoveris allows women with FSH and LH deficiency to develop a follicle, which will release an egg after an injection of the hormone human chorionic gonadotrophin (hCG). 
Zdravilo Pergoveris z nadomeščanjem manjkajočih hormonov ženskam s pomanjkanjem folikle stimulirajočega hormona in luteinizirajočega hormona omogoča nastanek folikla, iz katerega se bo po injiciranju hormona, imenovanega humani horionski gonadotropin (hCG), sprostilo jajčece.
In these studies, the combination of follitropin alfa and lutropin alfa at the same doses as in Pergoveris produced active follicles. 
V teh študijah je kombinacija folitropina alfa in lutropina lafa v enakih odmerkih kot v zdravilu Pergoveris spodbudila nastanek aktivnih foliklov.
These studies confirmed that Pergoveris produced similar blood levels of follitropin alfa and lutropin alfa as when the two medicines are given separately. 
Študije so potrdile, da zdravilo Pergoveris ustvari podobne ravni folitropina alfa in lutropina alfa v krvi kot dajanje teh učinkovin ločeno.
The active substances in Pergoveris, follitropin alfa and lutropin alfa, are copies of the natural hormones FSH and LH. 
Zdravilni učinkovini v zdravilu Pergoveris, folitropin alfa in lutropin alfa, sta kopiji naravnega folikle stimulirajočega hormona (FSH) in naravnega luteinizirajočega hormona (LH).
The medicine contains the active substances follitropin alfa and lutropin alfa. 
Zdravilo vsebuje zdravilni učinkovini folitropin alfa in lutropin alfa.
Thromboembolism (clots in the blood vessels) may occur very rarely, usually associated with severe OHSS. 
Trombembolizem (strdki v krvnih žilah) se pojavi zelo redko, navadno pa je značilen za hudo obliko sindroma hiperstimulacije jajčnikov.
In the body, FSH stimulates the production of eggs, and LH stimulates their release. 
Folikle stimulirajoči hormon v telesu spodbuja tvorbo jajčec, luteinizirajoči hormon pa spodbudi njihovo sprostitev.
How is Pergoveris used? 
Kako se zdravilo Pergoveris uporablja?
Mild or moderate OHSS is common, while severe OHSS is uncommon. 
Blag ali zmeren sindrom hiperstimulacije jajčnikov je pogost, huda oblika tega sindroma pa redka.
How does Pergoveris work? 
Kako zdravilo Pergoveris deluje?
It is intended for short-term use. 
Namenjeno je kratkotrajni uporabi.
Ref.: EMEA/644240/2009 EMEA/H/C/396 
: EMEA/644240/2009 EMEA/H/C/396
After five years, the marketing authorisation was renewed for a further five years. 
Po petih letih je bilo dovoljenje za promet z zdravilom podaljšano za nadaljnjih pet let.
Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary. 
Evropska agencija za zdravila bo vsako leto pregledala vse razpoložljive nove podatke in po potrebi posodobila ta povzetek.
All the studies looked at the number of patients who had died after 28 days. 
V vseh študijah so beležili število bolnikov, ki so umrli po 28 dneh.
If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR). 
Če želite več informacij, ki temeljijo na priporočilih CHMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
Xigris has been authorised under ‘Exceptional Circumstances'. 
Zdravilo Xigris je bilo odobreno v „izjemnih okoliščinah“.
The recommended dose of Xigris is 24 micrograms per kilogram body weight per hour, given as a continuous infusion for 96 hours. 
Priporočeni odmerek zdravila Xigris je 24 mikrogramov na kilogram telesne mase na uro, ki se daje kot neprekinjena infuzija v skupnem trajanju 96 ur.
The European Commission granted a marketing authorisation valid throughout the European Union for Xigris to Eli Lilly Nederland B.V. on 22 August 2002. 
Evropska komisija je dovoljenje za promet z zdravilom Xigris, veljavno po vsej Evropski uniji, odobrila družbi Eli Lilly Nederland B.V.
It must not be used in patients below 18 years of age, in patients who have long-term liver disease, a brain tumour or pressure on the brain, in patients also receiving high-dose heparin (another medicine used to prevent blood clots) or in patients who currently have internal bleeding or are at risk of bleeding. 
Ne sme se uporabljati pri bolnikih, mlajših od 18 let, pri bolnikih, ki imajo dolgotrajno obolenje jeter, možganski tumor ali pritisk v možganih, pri bolnikih, ki prejemajo heparin v visokih odmerkih (drugo zdravilo za preprečevanje krvnih strdkov), ali pri bolnikih, ki imajo notranjo krvavitev ali so v nevarnosti, da bodo krvaveli.
The toxins cause the patient's organs to fail, such as the heart, lungs and kidneys. 
Toksini povzročajo odpoved organov bolnika, kot so srce, pljuča, ledvice.
The Committee for Medicinal Products for Human Use (CHMP) decided that Xigris'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 Xigris večje od z njim povezanih tveganj, in priporočil, da se za zdravilo odobri dovoljenje za promet.
For the full list of restrictions, see the Package Leaflet. 
Za celoten seznam omejitev glejte navodilo za uporabo.
This means that it has not been possible to obtain complete information about Xigris. 
To pomeni, da o zdravilu ni bilo mogoče pridobiti vseh informacij.
Xigris is used when the patient has two or more organs failing, in addition to best standard care such as antibiotics, medicines to support the organs and treatment in a specialised unit. 
Zdravilo Xigris se uporablja, ko bolniku odpovedujeta dva organa ali več, kot dodatek najboljšemu standardnemu zdravljenju, kot so antibiotiki, zdravila za podporo organom in zdravljenje na specializiranem oddelku.
Other information about Xigris: 
Druge informacije o zdravilu Xigris:
Sepsis is a condition when bacteria get into the bloodstream and produce harmful substances (toxins). 
Sepsa je stanje, ko bakterije vstopijo v krvni obtok in tvorijo škodljive snovi (toksine).
Excessive blood clotting is a problem during severe sepsis, because blood clots can block the blood supply to important parts of the body such as the kidneys and lungs. 
Pri hudi sepsi je težava čezmerno strjevanje krvi, ker lahko krvni strdki ovirajo oskrbo pomembnih delov telesa s krvjo, kot so ledvice in pljuča.
The company that makes Xigris will conduct an additional study looking at the safety and effectiveness of Xigris in patients with severe sepsis. 
Družba, ki izdeluje zdravilo Xigris, bo opravila dodatno študijo, v kateri bo proučila varnost in učinkovitost zdravila pri bolnikih s hudo sepso.
• in the ADDRESS study, Xigris was compared with placebo in almost 3,000 patients who were at a lower risk of death than in the first two studies. 
• v študiji ADRESS so zdravilo Xigris primerjali s placebom pri skoraj 3 000 bolnikih, ki so bili manj življenjsko ogroženi kot v prvih dveh študijah.
In the body, drotrecogin alfa limits how much thrombin (one of the factors involved in blood clotting) is produced, and also reduces the inflammation caused by the infection. 
V telesu drotrekogin alfa omeji nastajanje trombina (enega od dejavnikov pri strjevanju krvi) ter zmanjša vnetje, ki ga povzroča okužba.
• in the ENHANCE study, over 2,000 patients received Xigris; 
• v študiji ENHANCE je zdravilo Xigris prejelo več kot 2 000 bolnikov;
The active substance in Xigris, drotrecogin alfa (activated), is very similar to a natural anticoagulant found in the body called activated protein C. Drotrecogin alfa is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce drotrecogin alfa. 
Zdravilna učinkovina zdravila Xigris, drotrekogin alfa (aktiviran), je zelo podobna naravnemu antikoagulacijskemu sredstvu v telesu, ki se imenuje aktiviran protein C. Drotrekogin alfa je izdelan z metodo, znano kot „tehnologija rekombinantne DNK“.
It contains the active substance drotrecogin alfa (activated). 
Vsebuje zdravilno učinkovino drotrekogin alfa (aktiviran).
Xigris should not be used in people who may be hypersensitive (allergic) to drotrecogin alfa (activated), any of the other ingredients or bovine thrombin (a cow protein). 
Zdravila Xigris ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) drotrekogin alfa (aktiviran), katero koli drugo sestavino zdravila ali na goveji trombin (kravjo beljakovino).
Xigris is an anticoagulant, which means that it stops the blood coagulating (clotting). 
Zdravilo Xigris je antikoagulant, kar pomeni, da preprečuje koagulacijo (strjevanje) krvi.
Fewer patients treated with Xigris had died at 28 days than patients treated with placebo. 
V 28 dneh je umrlo manj bolnikov, ki so prejemali zdravilo Xigris, kot bolnikov, ki so dobivali placebo.
What benefit has Xigris shown during the studies? 
Kakšne koristi je zdravilo Xigris izkazalo med študijami?
As with other anticoagulants, the most common side effect with Xigris is bleeding. 
Kot pri vseh antikoagulacijskih sredstvih je tudi pri zdravilu Xigris najpogostejši neželeni učinek krvavitev.
What is the risk associated with Xigris? 
Kakšna tveganja so povezana z zdravilom Xigris?
Xigris should be used by experienced doctors in institutions skilled in the care of patients with severe sepsis. 
Zdravilo Xigris morajo uporabljati izkušeni zdravniki v ustanovah z usposobljenim osebjem za zdravljenje bolnikov s hudo sepso.
The full EPAR for Xigris is available here. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Xigris je na voljo tukaj.
The effect of Xigris was more marked when it was given within 24 hours of the start of organ failure, and in patients who had more than one organ failing. 
Učinek zdravila Xigris je bil izrazitejši, če je bilo vzeto v 24 urah od pojava odpovedovanja organov, in pri bolnikih, ki jim je odpovedovalo več organov.
For the full list of all side effects reported with Xigris, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Xigris, glejte navodilo za uporabo.
• in the PROWESS study, Xigris was compared with placebo (dummy treatment) in 1,690 patients; 
• v študiji PROWESS so zdravilo Xigris pri 1 690 bolnikih primerjali s placebom (zdravilom brez zdravilne učinkovine);
What information is still awaited for Xigris? 
Katere informacije o zdravilu Xigris še pričakujemo?
By using Xigris during sepsis, the risk of blood clots forming and damaging the organs is reduced. 
Uporaba zdravila Xigris med sepso zmanjša nevarnost nastajanja krvnih strdkov, ki lahko poškodujejo organe.
Xigris drotrecogin alfa (activated) EPAR summary for the public 
drotrekogin alfa (aktiviran)
Why has Xigris been approved? 
Zakaj je bilo zdravilo Xigris odobreno?
Xigris should be used mainly when it can be started within 24 hours of the organ failure. 
Zdravilo Xigris je treba uporabiti zlasti, ko je mogoče zdravljenje začeti v 24 urah od pojava odpovedovanja organov.
Xigris has been studied in three studies in severe sepsis: 
Zdravilo Xigris so proučevali v treh študijah hude sepse:
Xigris is a powder that is made up into a solution for infusion (drip into a vein). 
Zdravilo Xigris je prašek za pripravo raztopine za infundiranje (kapalne infuzije v veno).
Xigris is used in adult patients with severe sepsis. 
Zdravilo Xigris se uporablja za zdravljenje bolnikov s hudo sepso.
Xigris should be started within 48 hours, and preferably within 24 hours, after the start of organ failure. 
Zdravljenje z zdravilom Xigris se mora začeti v 48 urah od pojava odpovedovanja organov, najbolje pa v 24 urah.
How does Xigris work? 
Kako zdravilo Xigris deluje?
Giving Xigris using an infusion pump is the recommended way to ensure that infusion rates are well controlled. 
Za natančen nadzor hitrosti infundiranja se za odmerjanje zdravila Xigris priporoča uporaba infuzijske črpalke.
How has Xigris been studied? 
Kako je bilo zdravilo Xigris raziskano?
What is Xigris used for? 
Za kaj se zdravilo Xigris uporablja?
What is Xigris? 
Kaj je zdravilo Xigris?
How is Xigris used? 
Kako se zdravilo Xigris uporablja?
Risk minimisation measures 
Ukrepi za zmanjšanje tveganja
The European Commission requested the Agency to give its opinion on whether the marketing authorisation for these products should be maintained, varied, suspended or withdrawn. 
Evropska komisija je agencijo zaprosila, naj poda svoje mnenje, ali naj se dovoljenje za promet s tema zdraviloma ohrani, spremeni, začasno umakne ali prekliče.
Treatment should be discontinued if the symptoms of angina do not improve within 3 months. 
Zdravljenje je treba prekiniti, če se simptomi angine ne izboljšajo v 3 mesecih;
Applying such a cut-off based on data from the BEAUTIFUL study is a reasonable measure to exclude patients who are likely to be at higher risk. 
Uporaba take omejitve, ki temelji na podatkih iz študije BEAUTIFUL, je razumen ukrep za izključitev bolnikov, ki bodo verjetno izpostavljeni večjemu tveganju.
As the absolute risk is based on 69 events, the possibilities for further analysis to identify the contributing risk factors are limited. 
Ker absolutno tveganje temelji na 69 dogodkih, so možnosti za nadaljnjo analizo za ugotavljanje sočasnih dejavnikov tveganja omejene.
CHMP opinion 
Mnenje odbora CHMP
The results of the SIGNIFY study were published4 while this review was ongoing and are discussed below. 
Rezultati študije SIGNIFY so bili objavljeni4, medtem ko je potekal pregled, in so opisani spodaj.
This highlights the need to comply with the currently authorized posology. 
To je poudarilo potrebo po upoštevanju trenutno odobrenega odmerjanja.
No significant differences were also observed in any of the secondary endpoints. 
Tudi pri sekundarnih opazovanih dogodkih niso opazili nobenih pomembnih razlik.
The frequency of atrium fibrillation (AF) was higher than currently described in the product information. 
Pogostnost atrijske fibrilacije (AF) je bila večja, kot je trenutno opisano v informacijah o zdravilu.
• The PRAC considered Procoralan and Corlentor (ivabradine) in the procedure under Article 20 of Regulation (EC) No 726/2004, initiated by the European Commission. 
• odbor PRAC je proučil zdravili Procoralan in Corlentor (ivabradin) v okviru postopka v skladu s členom 20 Uredbe (ES) št. 726/2004, ki ga je sprožila Evropska komisija;
• Reinforcement of the recommendation not to exceed the authorised posology. 
• okrepiti je treba priporočila, naj se ne preseže odobreno odmerjanje;
Ivabradine was also associated with a significantly higher risk of bradycardia. 
Ivabradin je bil prav tako povezan s pomembno večjim tveganjem bradikardije.
After three to four weeks of treatment, the dose may be increased to 7.5 mg twice daily depending on the therapeutic response. 
Po treh do štirih tednih zdravljenja je mogoče odmerek povečati na 7,5 mg dvakrat na dan, kar je odvisno od terapevtskega odziva.
2 - Detailed explanation of the scientific differences from PRAC recommendation 
- Podrobna obrazložitev znanstvenih odstopanj od priporočila PRAC
Nevertheless information monitoring of patients for AF needs to be reinforced. 
Kljub temu pa je treba informacije o spremljanju bolnikov za atrijsko fibrilacijo okrepiti.
The Product Information for Corlentor and Procoralan was revised to include the following: 
Informacije o zdravilih Corlentor in Procorlan so bile spremenjene, tako da vključujejo naslednje:
The individual components of the endpoint were not significantly increased. 
Posamezni komponenti opazovanega dogodka nista bili pomembno povečani.
Having reviewed the PRAC recommendation, the CHMP agreed with the overall scientific conclusions and grounds for recommendation. 
Po pregledu priporočila odbora PRAC se je odbor CHMP strinjal s splošnimi znanstvenimi zaključki in razlogi za priporočilo.
An additional risk minimisation activity was required by the PRAC. 
Odbor PRAC je zahteval dodatno ukrepanje za zmanjševanje tveganja.