natgillin/translations-raw huggingface dataset:
This means that it is similar to a ‘reference medicine' containing the same active substance, but Zalviso is available in a different form. 
To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje isto zdravilno učinkovino, vendar je zdravilo Zalviso na voljo v drugačni obliki.
The most serious side effect is respiratory depression (impaired breathing) which could potentially lead to the patient stopping breathing altogether. 
Najresnejši neželeni učinek je respiratorna depresija (težave pri dihanju), ki bi lahko povzročila, da bi bolnik prenehal dihati.
What measures are being taken to ensure the safe and effective use of Zalviso? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila
What benefits of Zalviso have been shown in studies? 
Kakšne koristi je zdravilo Zalviso izkazalo v študijah?
It is not intended to provide practical advice on how to use Zalviso. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
This allows the medicine to be transported to receptors in the brain and spinal cord where sufentanil acts to relieve pain. 
To omogoči prenos zdravila do receptorjev v možganih in hrbtenjači, kjer sufentanil deluje tako, da ublaži bolečino.
Because Zalviso is a hybrid generic, the applicant presented data on the reference medicine in addition to results from its own studies. 
Ker je zdravilo Zalviso hibridno generično zdravilo, je predlagatelj poleg rezultatov svojih študij predložil tudi podatke o referenčnem zdravilu.
Other information about Zalviso 
Druge informacije o zdravilu Zalviso
The most common side effects with Zalviso (which may affect more than 1 in 10 people) are nausea (feeling sick) and vomiting. 
Najpogostejša neželena učinka zdravila Zalviso (ki lahko prizadeneta več kot 1 osebo od 10) sta navzeja (slabost) in bruhanje.
Of 177 patients using Zalviso, 139 rated their pain control as excellent or good (79%), compared with 118 of 180 (66%) using morphine. 
Izmed 177 bolnikov, ki so uporabljali zdravilo Zalviso, jih je 139 način obvladovanja bolečine ocenilo kot odličen ali dober (79 %), medtem ko jih je od 180, ki so uporabljali morfin, tako oceno podalo 118 (66 %).
Zalviso is available as sublingual tablets containing 15 micrograms of sufentanil. 
Zdravilo Zalviso je na voljo v obliki podjezičnih tablet, ki vsebujejo 15 mikrogramov sufentanila.
When the patient places a Zalviso tablet under the tongue, a dose of sufentanil is rapidly absorbed into the blood stream through the blood vessels in the lining of the mouth. 
Ko si bolnik položi tableto Zalviso pod jezik, se odmerek sufentanila skozi krvne žile v ustni sluznici hitro absorbira v krvni obtok.
One main study involved 178 patients who had abdominal surgery (surgery on the belly) and another involved 426 patients who had surgery on the knee or hip. 
V eno glavno študijo je bilo vključenih 178 bolnikov, ki so imeli abdominalno operacijo (operacijo na trebuhu), v drugo pa 426 bolnikov z operacijo kolena ali kolka.
The reference medicine for Zalviso is called Sufenta Forte, and is available as a solution for injection, whereas Zalviso is available as sublingual tablets (tablets to be dissolved under the tongue). 
Referenčno zdravilo za zdravilo Zalviso se imenuje Sufenta Forte in je na voljo kot raztopina za injiciranje, medtem ko je zdravilo Zalviso na voljo v obliki podjezičnih tablet (tablet, ki se raztopijo pod jezikom).
For more information about treatment with Zalviso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Zalviso preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For abdominal surgery, the average decrease in pain intensity was 50 points greater with Zalviso than with placebo (106 versus 56). 
Pri abdominalnih operacijah je bilo povprečno zmanjšanje intenzivnosti bolečine pri uporabi zdravila Zalviso za 50 točk večje kot pri uporabi placeba (106 proti 56).
The device also uses an identifier so that only the patient who has been given a special thumb tag can release tablets. 
Na pripomočku je tudi identifikator, tako da lahko tablete uporabi le bolnik, ki je prejel posebno palčno oznako.
The active substance in Zalviso, sufentanil, is an opioid. 
Zdravilna učinkovina v zdravilu Zalviso, sufentanil, je opioid.
A third main study compared Zalviso with a patient-controlled pain relief system using morphine, another opioid, and involved 359 patients who had undergone major abdominal, knee or hip surgery. 
V tretji glavni študiji so zdravilo Zalviso primerjali s sistemom za blaženje bolečine, ki ga nadzira bolnik in uporablja drug opioid morfin; vanjo je bilo vključenih 359 bolnikov, ki so imeli veliko abominalno operacijo oziroma operacijo kolena ali kolka.
It contains the active substance sufentanil. 
Vsebuje zdravilno učinkovino sufentanil.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zalviso, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Zalviso in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The device locks for 20 minutes after the patient has taken a tablet and does not allow the patient to take more than 3 doses in one hour. 
Ko vzame tableto, se pripomoček za 20 minut zaklene in mu tako prepreči, da bi vzel več kot tri odmerke v eni uri.
How is Zalviso used? 
Kako se zdravilo Zalviso uporablja?
For practical information about using Zalviso, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Zalviso naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Zalviso is an opioid (a strong painkiller) that is used to treat pain occurring in adults after an operation. 
Zdravilo Zalviso je opioid (močno zdravilo za lajšanje bolečin), ki se uporablja za zdravljenje pooperativne bolečine pri odraslih.
In both cases Zalviso was compared with placebo (a dummy treatment). 
Zdravilo Zalviso so v obeh primerih primerjali s placebom (zdravilom brez zdravilne učinkovine).
For knee and hip surgery the decrease in pain intensity was around 88 points greater with Zalviso (76 versus -11) than with placebo. 
Pri operacijah kolena in kolka je bilo zmanjšanje intenzivnosti bolečine pri uporabi zdravila Zalviso za približno 88 točk večje kot pri uporabi placeba (76 proti -11).
The tablets are only for use in hospital and can only be obtained with a prescription from a doctor experienced in treating patients with opioids. 
Tablete so namenjene za uporabo le v bolnišnicah, njihova izdaja je le na recept, predpisati pa jih mora zdravnik z izkušnjami z zdravljenjem z opioidi.
For the full list of side effects and restrictions with Zalviso, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Zalviso glejte navodilo za uporabo.
EPAR summary for the public 
Povzetek EPAR za javnost sufentanil
The patient places the Zalviso tablets under their tongue when needed using a special device. 
Bolnik si tablete Zalvis, ko je to potrebno, s posebnim pripomočkom položi pod jezik.
How does Zalviso work? 
Kako zdravilo Zalviso deluje?
These side effects were normally mild or moderate. 
Ti neželeni učinki so bili običajno blagi ali zmerni.
The women were followed up for around three and a half years after the third dose of the vaccine. 
Ženske so spremljali približno tri leta in pol po prejemu tretjega odmerka cepiva.
These virus-like particles are not capable of causing infection or disease. 
Ti virusu podobni delci ne morejo povzročiti okužb ali bolezni.
The vaccine also contains an ‘adjuvant', a compound containing aluminium to stimulate a better response. 
Cepivo vsebuje tudi adjuvans (spojino, ki vsebuje aluminij) za spodbujanje boljšega odziva.
This is a summary of the European public assessment report (EPAR) for Gardasil 9. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Gardasil 9.
The European Commission granted a marketing authorisation valid throughout the European Union for Gardasil 9 on 10 June 2015. 
Evropska komisija je dovoljenje za promet z zdravilom Gardasil 9, veljavno po vsej Evropski uniji, izdala 10. junija 2015.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Gardasil 9'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 Gardasil 9 večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The full EPAR and risk management plan summary for Gardasil 9 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) in povzetek načrta obvladovanja tveganj za zdravilo Gardasil 9 sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
For the full list of all restrictions, see the package leaflet. 
Za celoten seznam omejitev glejte navodilo za uporabo.
The vaccine is given as an injection into a muscle, preferably in the shoulder or the thigh. 
Cepivo se daje v obliki injekcije v mišico, po možnosti v rame ali stegno.
There are more than 100 types of papillomavirus, some of which are associated with anogenital cancers in both men and women. 
Obstaja več kot 100 tipov papilomavirusov, od katerih nekatere povezujejo z rakavimi obolenji na spolovilih in zadnjiku pri moških in ženskah.
What measures are being taken to ensure the safe and effective use of Gardasil 9? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Gardasil 9?
A further 5 HPV types (31, 33, 45, 52, and 58) also carry a high risk for developing cancer (they cause around 20% of cervical cancers). 
Pet dodatnih tipov (31, 33, 45, 52 in 58) prav tako prinaša večje tveganje za razvoj raka (ti tipi povzročajo približno 20 % rakavih obolenj materničnega vratu).
Gardasil 9 is given according to official recommendations. 
Cepivo Gardasil 9 se daje v skladu z uradnimi priporočili.
In Europe, approximately 90% of anal cancers, 15% of vulvar cancers, 70% of vaginal cancers, and 30 to 40% of penile cancers are estimated to be caused by HPV infection. 
V Evropi je po ocenah 90 % rakavih obolenj zadnjika, 15 % rakavih obolenj vulve, 70 % rakavih obolenj nožnice in od 30 do 40 % rakavih obolenj penisa posledica okužbe s humanim papilomavirusom.
This study also showed that antibody levels against types 6, 11, 16 and 18 were adequate to protect against these four types of HPV infection. 
Študija je prav tako pokazala, da so ravni protiteles proti tipom 6, 11, 16 in 18 zadoščale za zaščito pred okužbo s temi štirimi tipi humanega papilomavirusa.
Regarding side effects, although a large proportion of subjects develop injection site reactions, these are only slightly more than for Gardasil. 
Kar zadeva neželene učinke, se pri velikem deležu oseb pojavijo reakcije na mestu injiciranja, vendar je njihova pojavnost le nekoliko višja kot pri zdravilu Gardasil.
In studies, the most common side effects with Gardasil 9 (seen in more than 1 patient in 10) were reactions at the site of the injection (redness, pain and swelling) and headache. 
V študijah so bili najpogostejši neželeni učinki zdravila Gardasil 9 (opaženi pri več kot 1 osebi od 10) reakcije na mestu injiciranja (rdečina, bolečina in oteklina) in glavobol.
Other information about Gardasil 9 
Druge informacije o zdravilu Gardasil 9
A risk management plan has been developed to ensure that Gardasil 9 is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Gardasil 9 je bil pripravljen načrt obvladovanja tveganj.
For more information about treatment with Gardasil 9, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Gardasil 9 preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The main measure of effectiveness was the development of antibodies against HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 one month after the third dose. 
Glavno merilo učinkovitosti je bil razvoj protiteles proti humanim papilomavirusom tipov 6, 11, 16, 18, 31, 33, 45, 52 in 58 mesec dni po tretjem odmerku.
Gardasil 9 is a suspension for injection available in vials or prefilled syringes. 
Zdravilo Gardasil 9 je suspenzija za injiciranje, ki je na voljo v vialah ali napolnjenih injekcijskih brizgah.
The fifth main study involving 1,518 subjects compared the effect of a two-dose schedule of Gardasil 9 with a three-dose schedule. 
V okviru pete glavne študije, v katero je bilo vključenih 1 518 oseb, so primerjali učinke sheme z dvema odmerkoma zdravila Gardasil 9 s shemo s tremi odmerki.
What are the risks associated with Gardasil 9? 
Kakšna tveganja so povezana z zdravilom Gardasil 9?
What is Gardasil 9 and what is it used for? 
Kaj je zdravilo Gardasil 9 in za kaj se uporablja?
• precancerous lesions (growths) and cancers in the cervix, vulva or vagina and anus; 
• predrakavimi lezijami (nenormalno rastjo celic) in rakom materničnega vratu, vulve, nožnice in zadnjika,
For practical information about using Gardasil 9, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Gardasil 9 naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
It contains purified proteins from the nine types of HPV listed above. 
Vsebuje prečiščene beljakovine devetih tipov humanih papilomavirusov, navedenih zgoraj.
Thus Gardasil 9 is expected to prevent the majority of cervical, vaginal and vulvar cancers and premalignant lesions, as well as genital warts associated with HPV. 
Za zdravilo Gardasil 9 se pričakuje, da bo preprečilo večino rakavih obolenj materničnega vratu, nožnice in vulve ter predrakavih lezij ter tudi bradavic na spolovilih, ki so povezane s humanim papilomavirusom.
Gardasil 9 contains the purified L1 proteins for the nine HPV types above, produced by a method known as ‘recombinant DNA technology'. 
Zdravilo Gardasil 9 vsebuje prečiščene beljakovine L1 za devet zgoraj navedenih tipov humanega papilomavirusa, ki so pridobljene z metodo, imenovano tehnologija rekombinantne DNK.
For a three-dose schedule, the second dose should be given two months after the first and the third given four months after the second. 
Pri shemi s tremi odmerki je treba dati drugi odmerek dva meseca po prvem, tretjega pa štiri mesece po drugem.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Gardasil 9, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What benefits of Gardasil 9 have been shown in studies? 
Kakšne koristi je zdravilo Gardasil 9 izkazalo v študijah?
Patients who show signs of an allergy after a dose of Gardasil 9 (or of its precursor vaccines Gardasil or Silgard) should stop the vaccination course or should not receive Gardasil 9 at all. 
Osebe, ki po odmerku zdravila Gardasil 9 (ali cepiv Gardasil oziroma Silgard, ki sta njegova predhodnika) kažejo znake alergijske reakcije, morajo cepljenje prekiniti oziroma zdravila Gardasil 9 sploh ne smejo prejeti.
Gardasil 9 can provide protection against all nine types of HPV infection, as seen in five main studies. 
Zdravilo Gardasil 9 ščiti pred okužbo z vsemi devetimi tipi humanega papilomavirusa, kot je bilo dokazano v petih glavnih študijah.
The first study looked at the effectiveness of Gardasil 9 in over 14,000 women aged between 16 and 26 years. 
V okviru prve študije so raziskovali učinkovitost zdravila Gardasil 9 pri več kot 14 000 ženskah, starih od 16 do 26 let.
Nearly 100% of cervical cancers are caused by HPV infection. 
Skoraj 100 % rakavih obolenj materničnega vratu povzroči okužba s humanim papilomavirusom.
Why is Gardasil 9 approved? 
Zakaj je bilo zdravilo Gardasil 9 odobreno?
For a twodose schedule, the second dose should be given between five and thirteen months after the first dose. 
Pri shemi z dvema odmerkoma je treba dati drugi odmerek v petih do trinajstih mesecih po prvem.
Gardasil 9 is a vaccine used in males and females from the age of nine years to protect against the following conditions caused by nine types of the human papillomavirus (HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58): 
Zdravilo Gardasil 9 je cepivo, ki se uporablja pri moških in ženskah, starejših od devet let, za zaščito pred naslednjimi vrstami obolenj, ki jih povzroča devet tipov humanih papilomavirusov (tipi HPV 6, 11, 16, 18, 31, 33, 45, 52 in 58):
For the full list of all side effects reported with Gardasil 9, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Gardasil 9, glejte navodilo za uporabo.
The fourth main study compared the levels of antibodies against all nine HPV types one month after the third dose in around 1,419 young men aged 16 to 26 with those in 1,101 women aged 16 to 26. 
V okviru četrte glavne študije so mesec dni po tretjem odmerku primerjali ravni protiteles proti vsem devetim tipom humanega papilomavirusa pri 1 419 moških, starih od 16 do 26 let, in pri 1 101 ženski, stari od 16 do 26 let.
HPV types 16 and 18 cause a large majority of cervical and anal cancers, while HPV types 6 and 11 cause most of genital warts. 
Tipa 16 in 18 humanega papilomavirusa povzročata večino rakavih obolenj nožnice in zadnjika, tipa 6 in 11 pa večino bradavic na spolovilih.
It is recommended that individuals who receive the first dose of Gardasil 9 should complete the dosing regimen using this medicine. 
Priporočljivo je, da osebe, ki so prejele prvi odmerek zdravila Gardasil 9, celotno shemo cepljenja opravijo z istim cepivom.
There should always be at least one month between the first and the second doses, and at least three months between the second and the third, and all doses should be given within a year. 
Med prvim in drugim odmerkom mora vedno preteči vsaj en mesec, med drugim in tretjim pa vsaj trije meseci.
human papillomavirus 9-valent vaccine (recombinant, adsorbed) 
devetvalentno cepivo (rekombinantno, adsorbirano) proti humanim papilomavirusom
Gardasil 9 is normally given according to a either a two-dose schedule or a three-dose schedule for males and females from 9 to 14 years old and a three-dose schedule for males and females 15 years old and over. 
Običajno se daje po shemi cepljenja z dvema odmerkoma ali tremi odmerki za moške in ženske, stare od 9 do 14 let ter shemi cepljenja s tremi odmerki za moške in ženske, starejše od 15 let.
The second study in 3066 subjects compared the effect of Gardasil 9 in girls and boys aged nine to 15 years with the effect of Gardasil 9 in young women aged 16 to 26 years. 
V drugi študiji, v katero je bilo vključenih 3 066 oseb, so učinek zdravila Gardasil 9 pri dekletih in fantih, starih od 9 do 15 let, primerjali z učinkom zdravila Gardasil 9 pri mladih ženskah, starih od 16 od 26 let.
This study looked at the development of antibodies one month after the last dose, and it showed that boys and girls given two doses of Gardasil 9 have similar levels of protection against all nine virus types to girls and women given three doses of Gardasil 9. 
Ta študija, v kateri so proučevali razvoj protiteles mesec dni po zadnjem odmerku, je pokazala, da so imeli dečki in deklice, ki so prejeli dva odmerka zdravila Gardasil 9 podobne ravni zaščite proti vsem devetim tipom virusa kot dekleta in ženske, ki so prejele tri odmerke zdravila Gardasil 9.
The CHMP considered that Gardasil 9 offers a broader protection against cancer than its precursor Gardasil, since it protects against additional 5 new types of HPV (31, 33, 45, 52 and 58), which although less common than types 16 and 18, are also considered high-risk HPV types. 
Menil je, da zdravilo Gardasil 9 zagotavlja širšo zaščito pred rakavimi obolenji kot zdravilo Gardasil, ki je njegov predhodnik, saj ščiti pred dodatnimi petimi tipi HPV (31, 33, 45, 52 in 58), ki so sicer manj razširjeni kot tipa 16 in 18, vendar prav tako spadajo med tipe humanega papilomavirusa z visokim tveganjem.
This study showed that 1 out of 6,016 women vaccinated with 3 doses of Gardasil 9 developed disease related to HPV types 31, 33, 45, 52 and 58, compared with 30 out of 6,017 women vaccinated with 3 doses of Gardasil. 
Študija je pokazala, da je od 6 016 žensk, cepljenih s tremi odmerki zdravila Gardasil 9, za boleznijo, povezano s humanim papilomavirusom tipov 31, 33, 45, 52 ali 58, zbolela ena, od 6 017 žensk, cepljenih s tremi odmerki zdravila Gardasil, pa jih je zbolelo 30.
It is not intended to provide practical advice on how to use Gardasil 9. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
This study found that Gardasil 9 stimulates similar levels of protection against all nine virus types in young men and women. 
Študija je pokazala, da pri mladih moških in ženskah zdravilo Gardasil 9 spodbudi podobne ravni zaščite proti vsem devetim tipom virusa.
The study looked at how many women given Gardasil 9 developed disease (growths or cancer) due to HPV infection caused by HPV types 31, 33, 45, 52 and 58 when compared with Gardasil vaccine (a previously approved vaccine which protects against types 6, 11, 16 and 18). 
V študiji so proučevali, pri koliko ženskah, ki so prejele zdravilo Gardasil 9, se je pojavila bolezen (nenormalna rast celic ali rakavo obolenje) zaradi okužbe s humanim papilomavirusom tipov 31, 33, 45, 52 in 58 v primerjavi s cepivom Gardasil (že odobrenim cepivom, ki ščiti pred okužbami s to boleznijo tipov 6, 11, 16 in 18).
The study looked at the development of antibodies one month after the third dose, and it showed that girls vaccinated with Gardasil 9 have similar levels of protection against types 6, 11, 16 and 18 as girls vaccinated with Gardasil. 
Študija, v kateri so proučevali razvoj protiteles mesec dni po tretjem odmerku, je pokazala, da je raven zaščite proti tipom 6, 11, 16 in 18 pri deklicah, cepljenih z zdravilom Gardasil 9, podobna kot pri deklicah, cepljenih z zdravilom Gardasil.
How is Gardasil 9 used? 
Kako se zdravilo Gardasil 9 uporablja?
How does Gardasil 9 work? 
Kako zdravilo Gardasil 9 deluje?
The study showed that the vaccine stimulates the production of adequate levels of antibodies against HPV of all nine types in girls and boys aged between nine and 15 years when compared with women 16-26 years of age, for whom protection against disease was demonstrated in the first study. 
Študija je pokazala, da v primerjavi z ženskami, starimi od 16 do 26 let, pri katerih je bila učinkovitost zaščite pred boleznimi dokazana v prvi študiji, cepivo pri dekletih in fantih, starih od 9 do 15 let, spodbuja razvoj zadostnih ravni protiteles proti vsem devetim tipom HPV.
The third study compared the effect of Gardasil 9 with the effect of Gardasil in 600 girls aged 9 to 15 years. 
V okviru tretje študije so pri 600 deklicah, starih od 9 do 15 let, učinkovitost zdravila Gardasil 9 primerjali z učinkovitostjo zdravila Gardasil.
The study should be conducted in more than one Member State. 
Študija mora biti izvedena v več kot eni državi članici.
The protocol shall be submitted in accordance with Article 107n (1) of Directive 2001/83/EC: 
Protokol je treba predložiti v skladu s členom 107n (1) Direktive 2001/83/ES:
Within 6 months of the Coordination group agreement. 
v 6 mesecih od sporazuma usklajevalne skupine
Further interim reports should be submitted to the PRAC 6-monthly thereafter for the first 2 years. 
Preostala vmesna poročila je treba nato odboru PRAC predložiti vsakih 6 mesecev prvi 2 leti.