natgillin/translations-raw huggingface dataset:
There should be no noticeable effects if you stop taking Rapinyl, but possible symptoms of withdrawal are anxiety, tremor, sweating, paleness, nausea and vomiting. 
Pri ukinitvi zdravljenja z Rapinylom ne bi smelo biti opaznejših učinkov, kljub temu so možni odtegnitveni simptomi kot so strah, tremor, potenje, bledica, slabost in bruhanje.
You may need to try different strengths of Rapinyl sublingual tablets over a number of episodes of breakthrough pain to find the most appropriate dose. 
Morda bo potrebno tekom zdravljenja več epizod prebijajoče bolečine uporabiti različne jakosti, preden se določi odmerek, ki je za vas najprimernejši.
Applicant for analyzing only SAEs at this stage are endorsed, and the absence of new important safety issues was considered re-assuring by the CHMP, a full safety analysis should be provided by the Applicant. 
Odbor za zdravila za uporabo v humani medicini sicer sprejema razloge predlagatelja za analiziranje le resnih neželenih dogodkov v tej fazi in pozitivno ocenjuje dejstvo, da se niso pojavila nobena nova varnostna vprašanja, hkrati pa meni, da mora predlagatelj predložiti tudi popolno varnostno analizo.
Fentanyl is excreted into breast milk and may cause sedation and respiratory depression in the breastfed child. Fentanyl should only be used by breast-feeding women if the benefits clearly outweigh the potential risks for both mother and child. 
Fentanil naj bi se doječim ženskam predpisoval samo, če koristi jasno odtehtajo potencialne nevarnosti tako za mater kot za otroka.
Rapinyl is intended for the treatment of breakthrough pain in patients using opioid therapy for chronic cancer pain. 
Zdravilo Rapinyl je namenjeno lajšanju prebijajočih bolečin pri bolnikih s kroničnimi bolečinami zaradi raka, ki se zdravijo z opioidnimi terapijami.
Each sublingual tablet contains 50 micrograms fentanyl (as citrate) 100 micrograms fentanyl (as citrate) 
Vsaka sublingvalna tableta vsebuje 50 mikrogramov fentanila v obliki fentanilijevega citrata 100 mikrogramov fentanila v obliki fentanilijevega citrata
Similarly, the Applicant considered the clinical safety of fentanyl products to be well established and well tolerated in both volunteers and the target population and that the pattern of side effects was consistent with other fentanyl products, including those used for treating BTP. 
Predlagatelj je nadalje menil, da je klinična varnost zdravil s fentanilom ustrezno dokazana, da jih tako prostovoljci kot tudi ciljna populacija dobro prenašajo in da so vzorci neželenih učinkov podobni kot pri drugih zdravilih s fentanilom, vključno s tistimi za zdravljenje prebijajočih bolečin pri raku.
ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET 
DODATEK III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA OZNAČEVANJE IN NAVODILO ZA UPORABO
If you take more Rapinyl than you should 
Če ste uporabili večji odmerek zdravila Rapinyl, kot bi smeli:
Therefore, the CHMP was unable to agree that the safety and efficacy profile of Rapinyl could be anticipated from the provided documentation. 
Tako CHMP ni mogel potrditi, da se lahko na osnovi podatkov, predloženih v dokumentaciji, sklepa o profilu varnosti in učinkovitosti zdravila Rapinyl.
What Rapinyl is and what it is used for Before you take Rapinyl How to take Rapinyl Possible side effects How to store Rapinyl Further information 
Kaj je Rapinyl in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Rapinyl Kako jemati Rapinyl
Repeated administration of the opioid antagonist may be necessary if the duration of respiratory depression is prolonged. 
Če depresija dihanja traja dalj časa, bo morda potrebno antagonist opioida dati večkrat.
Ask your doctor or pharmacist for advice before taking any medicine when pregnant or breast-feeding. 
Če ste noseči ali če dojite, se posvetujte s svojim zdravnikom, preden začnete jemati kakršnokoli zdravilo.
Rapinyl is a rapidly disintegrating sublingual tablet designed to rapidly and predictably deliver fentanyl through the oral mucosa. 
Zdravilo Rapinyl je hitro topljiva sublingvalna tableta, oblikovana tako, da fentanil hitro in načrtno pronica skozi oralno sluznico.
- the dose range of Rapinyl and the dose proportionalilty between Actiq and Rapinyl was considered as established 
- sta razpon odmerkov zdravila Rapinyl in sorazmernost odmerkov med zdravilom Actiq in zdravilom Rapinyl ustrezno dokazana,
Whereas 
Ob upoštevanju, da
Pharmacotherapeutic group: Phenylpiperidine derivatives, ATC code: N02ABO3 
Farmakoterapevtska skupina: Derivati fenilpiperidina.
You should only stop taking Rapinyl sublingual tablets on the advice of your doctor. 
Z jemanjem Rapinyl podjezičnih tablet smete prenehati samo, če vam je tako naročil vaš zdravnik.
Common: Vomiting, abdominal pain, diarrhoea, constipation, stomach discomfort, dyspepsia, dry mouth 
Pogosti: bruhanje, bolečine v trebuhu, driska, zaprtost, neprijeten občutek v želodcu, dispepsija, suha usta
Rapinyl is not recommended for use in patients who have received monoamine oxidase (MAO) inhibitors within 14 days because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics. 
Pri sočasni uporabi zaviralcev MAO in opioidnih analgetikov so poročali o resnem in nepredvidljivem potenciranju učinkov opioidnih analgetikov, zato se uporaba Rapinyla ne priporoča pri bolnikih, ki so v obdobju 14 dni prejemali zaviralce monoaminooksidaze (MAO).
What Rapinyl contains 
Kaj vsebuje zdravilo Rapinyl
Spain 
¨Španija
Taking the medicine 
Uporaba zdravila:
The packaging is colour-coded for each Rapinyl sublingual tablet strength. 
Barva ovojnine se razlikuje glede na jakost Rapinyl sublingvalnih tablet.
Orally administered fentanyl undergoes pronounced hepatic and intestinal first pass effects. 
Peroralno odmerjen fentanil je izrazito podvržen predsistemskemu metabolizmu v jetrih in prebavilih.
The pain-relieving medicine in Rapinyl is very strong and could be life-threatening if taken accidentally by a child. Rapinyl must be kept out of the reach and sight of children. 
Učinkovina za lajšanje bolečin v zdravilu Rapinyl je zelo močna in lahko ogrozi življenje, če ga po nesreči vzame otrok.
Renal/hepatic impairment 
Okvara ledvic/jeter
HOW TO TAKE RAPINYL 
KAKO JEMATI ZDRAVILO RAPINYL
Up to this date there were no reports of any SAEs assessed as being related to Rapinyl in either study. 
Do danes ni nobenih poročil o resnih neželenih učinkih pri kateri koli od navedenih študij, ki bi bili posledica uporabe zdravila Rapinyl.
Driving and using machines 
Vpliv na vožnjo in sposobnost upravljanja strojev:
Common: Gastro-intestinal occlusion, dysphagia, mouth ulcers/stomatitis, tongue disorder Uncommon: Enlarged abdomen, flatulence, thirst Rare: Hiccups 
Pogosti: gastrointestinalna okluzija, disfagija, razjede v ustih/stomatitis, spremembe na jeziku Občasni: povečan trebuh, flatulenca, žeja
An extrapolation of the PID at 10 and 15 minutes to responder rates has been provided by the Applicant. 
Predlagatelj je predložil tudi ekstrapolacijo razlik v jakosti bolečine pri sodelujočih v 10 in 15 minutah.
Rapinyl should only be administered to patients who are considered tolerant to their opioid therapy for persistent cancer pain. 
Rapinyl se naj daje samo bolnikom, za katere velja, da so razvili toleranco na opioide pri zdravljenju kronične bolečine pri raku.
The safety of fentanyl in pregnancy has not been established. 
Za uporabo fentanila med nosečnostjo niso ugotovili, ali je varna.
Carton Label 
Oznaka na ovojnini
The 100 microgram tablet is a white round tablet The 200 microgram tablet is a white oval-shaped tablet The 300 microgram tablet is a white triangle-shaped tablet The 400 microgram tablet is a white diamond-shaped tablet The 600 microgram tablet is a white “D”-shaped tablet The 800 microgram tablet is a white capsule-shaped tablet 
600 mikrogramska Podjezična tableta je bela tableta v obliki črke D. 800 mikrogramska Podjezična tableta je bela tableta v obliki kapsule.
Due to the low number of patients exposed for a long time, the final results of the studies EN3267-005 and EN3267-007 should be provided as conditions to the Marketing Authorisations. 
Zaradi majhnega števila bolnikov, ki so bili zdravilu izpostavljeni dalj časa, je kot pogoj za pridobitev dovoljenja za promet z zdravilom potrebno predložiti tudi končne rezultate študij En3267
Rapinyl 800 µg sublingual tablets 
Rapinyl 800 µg podjezične tablete
• You should not drink or eat anything until the tablet has completely dissolved under your tongue. 
• Dokler se tableta ni do konca raztopila pod vašim jezikom, ne smete ne jesti ne piti.
One sublingual tablet contains 50 micrograms fentanyl (as citrate) 100 micrograms fentanyl (as citrate) 
Ena podjezična tableta vsebuje: 50 mikrogramov fentanila v obliki fentanilijevega citrata
Rapinyl 400 µg sublingual tablets 
Rapinyl 400 µg podjezične tablete
Rapinyl 300 µg sublingual tablets 
Rapinyl 300 µg podjezične tablete
Rapinyl 100 µg sublingual tablets 
Rapinyl 100 µg podjezične tablete
800 micrograms fentanyl (as citrate) 
800 mikrogramov fentanila v obliki fentanilijevega citrata
Muscle rigidity interfering with respiration has been reported with fentanyl and other opioids. 
Pri fentanilu in drugih opioidih so poročali o mišični otrplosti, ki otežuje dihanje.
600 micrograms fentanyl (as citrate) 
600 mikrogramov fentanila v obliki fentanilijevega citrata
200 micrograms fentanyl (as citrate) 
200 mikrogramov fentanila v obliki fentanilijevega citrata
400 micrograms fentanyl (as citrate) 
400 mikrogramov fentanila v obliki fentanilijevega citrata
Rapinyl 200 µg sublingual tablets 
Rapinyl 200 µg podjezične tablete
Rapinyl 600 µg sublingual tablets 
Rapinyl 600 µg podjezične tablete
300 micrograms fentanyl (as citrate) 
300 mikrogramov fentanila v obliki fentanilijevega citrata
Silicified microcrystalline cellulose Croscarmellose sodium 
6.1 Seznam pomožnih snovi manitol (E421) silicirana mikrokristalna celuloza natrijev karmelozat, premreženi magnezijev stearat
Rapinyl 800 microgram sublingual tablets 
Rapinyl 800 mikrogramske podjezične tablete
Opioid-naïve patients because of the risk of life-threatening respiratory depression. 
Uporaba Rapinyla je zaradi tveganja življenjsko nevarne depresije dihanja kontraindicirana pri bolnikih, ki še niso prejemali opioidov.
Rapinyl 400 microgram sublingual tablets 
Rapinyl 400 mikrogramske podjezične tablete
50 microgram sublingual tablet is a white pentagon-shaped tablet 100 microgram sublingual tablet is a white round tablet 200 microgram sublingual tablet is a white oval-shaped tablet 300 microgram sublingual tablet is a white triangle-shaped tablet 400 microgram sublingual tablet is a white diamond-shaped tablet 600 microgram sublingual tablet is a white “D”-shaped tablet 800 microgram sublingual tablet is a white capsule-shaped tablet 
600 mikrogramska podjezična tableta je bela tableta v obliki črke D. 800 mikrogramska podjezična tableta je bela tableta v obliki kapsule.
STATEMENT OF ACTIVE SUBSTANCE(S) 
Sklep o seznamu vprašanj
EU (MA) Number 
Številka (EU) dovoljenja za promet z zdravilom
Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States 
Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
Five main studies were carried out. 
Opravljenih je bilo pet glavnih študij.
Further information on Imvanex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/imvanex. 
Nadaljnje informacije za zdravilo Imvanex so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/imvanex.
It is not yet known how long the protection will last. 
Ni pa znano, kako dolgo zaščita traja.
Smallpox was officially declared eradicated in 1980 with the last known case of the disease occurring in 1977. 
Črne koze so bile leta 1980 uradno razglašene za izkoreninjeno bolezen, zadnji znani primer bolezni pa je iz leta 1977.
This vaccine will be used when it is considered necessary to protect against smallpox in accordance with official recommendations. 
To cepivo se bo uporabljalo, ko se bo ocenilo, da je potrebna zaščita pred črnimi kozami v skladu z uradnimi priporočili.
Imvanex (live modified vaccinia ankara virus) 
Imvanex (živ modificiran virus vakcinija Ankara)
Vaccines work by ‘teaching' the immune system how to defend itself against a disease. 
Cepiva delujejo tako, da imunski sistem „naučijo“, kako naj se brani pred boleznijo.
The most common side effects with Imvanex (which may affect more than 1 in 10 people) are headache, nausea, myalgia (muscle pain), tiredness and injection site reactions (pain, redness, swelling, hardening and itching). 
Najpogostejši neželeni učinki zdravila Imvanex (ki se lahko pojavijo pri več kot 1 od 10 oseb) so glavobol, siljenje na bruhanje, mialgija (bolečine v mišicah), utrujenost in reakcije na mestu injiciranja (bolečina, rdečina, oteklina, zatrdlina in srbečica).
When the person comes into contact again with this or a similar virus, these antibodies together with other components of the immune system will be able to kill the viruses and help protect against the disease. 
Ko je oseba ponovno izpostavljena temu ali podobnemu virusu, ta protitelesa skupaj z drugimi mehanizmi imunskega sistema uničijo virus in pripomorejo k zaščiti pred boleznijo.
What measures are being taken to ensure the safe and effective use of Imvanex? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Imvanex?
Imvanex received a marketing authorisation valid throughout the EU on 31 July 2013. 
Za zdravilo Imvanex je bilo 31. julija 2013 izdano dovoljenje za promet, veljavno po vsej EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imvanex have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Imvanex upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Since Imvanex has been authorised under exceptional circumstances, the company that markets Imvanex will provide data on the vaccine's benefits and risks from observational studies in patients who are given the vaccine, and if ever there is an outbreak of the disease in the future. 
Ker je zdravilo Imvanex pridobilo dovoljenje za promet v izjemnih okoliščinah, bo podjetje, ki ga trži, zagotovilo podatke o koristih in tveganjih cepiva, pridobljene z opazovalnimi študijami pri bolnikih, ki so prejeli cepivo, in ob morebitnem izbruhu bolezni v prihodnosti.
As for all medicines, data on the use of Imvanex are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Imvanex stalno spremljajo.
The studies involved over 2,000 adults, including patients with HIV and atopic dermatitis (an itchy skin condition caused by an overactive immune system) and people who had been vaccinated against smallpox in the past. 
V teh študijah je sodelovalo več kot 2 000 odraslih, med katerimi so bili bolniki z virusom HIV in atopijskim dermatitisom (srbečimi kožnimi izpuščaji zaradi čezmerno dejavnega imunskega sistema) ter posamezniki, ki so v preteklosti že bili cepljeni proti črnim kozam.
Imvanex has been authorised under ‘exceptional circumstances'. 
Zdravilo Imvanex je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
For more information about using Imvanex, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Imvanex glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
An overview of Imvanex and why it is authorised in the EU 
Pregled zdravila Imvanex in zakaj je odobreno v EU
When a person is given the vaccine, the immune system recognises the virus in the vaccine as ‘foreign' and makes antibodies against it. 
Ko oseba prejme cepivo, imunski sistem prepozna virus v cepivu kot „tujek“ in začne proti njemu tvoriti protitelesa.
Imvanex must not be used in patients who are hypersensitive (allergic) to the active substance or any of the substances found at trace levels, such as chicken protein, benzonase and gentamicin. 
Zdravilo Imvanex se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) učinkovino ali katero koli drugo sestavino, ki je prisotna v sledeh, na primer na piščančje beljakovine, benzonazo in gentamicin.
Other information about Imvanex 
Druge informacije o zdravilu Imvanex
Side effects reported with Imvanex are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Imvanex, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Imvanex would therefore be beneficial for people who cannot be given vaccines containing replicating viruses, such as patients with a weakened immune system. 
Zdravilo Imvanex bi bilo zato koristno za osebe, pri katerih se ne smejo uporabiti cepiva z virusi, ki se podvajajo, na primer za bolnike z oslabljenim imunskim sistemom.
Vaccines containing vaccinia viruses were effective in the campaign to eradicate smallpox. 
Cepiva, ki vsebujejo viruse vakcinija, so bila učinkovita v okviru prizadevanj za izkoreninjenje črnih koz.
A subsequent study in 433 people who had not been vaccinated before found that the level of protective antibodies after vaccination with Imvanex was at least as high as with a conventional smallpox vaccine. 
Naknadna študija pri 433 ljudeh, ki pred tem niso bili cepljeni, je pokazala, da je bila po cepljenju z zdravilom Imvanex koncentracija zaščitnih protiteles vsaj tako visoka kot pri običajnem cepivu proti črnim kozam.
Why is Imvanex authorised in the EU? 
Zakaj je bilo zdravilo Imvanex odobreno v EU?
What is Imvanex and what is it used for? 
Kaj je zdravilo Imvanex in za kaj se uporablja?
What benefits of Imvanex have been shown in studies? 
Kakšne koristi zdravila Imvanex so se pokazale v študijah?
It contains a live modified form of the vaccinia virus called ‘vaccinia Ankara', which is related to the smallpox virus. 
Vsebuje živo modificirano obliko virusa vakcinija, ki se imenuje „vakcinija Ankara“ in je soroden virusu črnih koz.
Two of the studies specifically looked at the effectiveness of Imvanex as a booster. 
V dveh študijah so se osredotočili predvsem na učinkovitost zdravila Imvanex kot poživitvenega cepljenja.
Imvanex contains a modified form of the vaccinia virus called vaccinia Ankara, which does not cause disease in humans and cannot replicate (reproduce) in human cells. 
Zdravilo Imvanex vsebuje modificirano obliko virusa vakcinija, imenovanega vakcinija Ankara, ki ne povzroča bolezni pri ljudeh in se v človeških celicah ne more podvajati.
The vaccinia virus in Imvanex cannot replicate in human cells and hence is less likely to cause side effects than conventional smallpox vaccines. 
Virus vakcinija v zdravilu Imvanex se v človeških celicah ne more podvajati, zato je manj možnosti za neželene učinke kot pri običajnih cepivih proti črnim kozam.
If a booster dose is necessary for those who have been vaccinated against smallpox in the past, a single 0.5 ml dose should be given except for patients with a weakened immune system (the body's natural defences) who should receive two booster doses, with the second dose given at least 28 days after the first. 
Če je pri posameznikih, ki so v preteklosti že bili cepljeni proti črnim kozam, potreben poživitveni odmerek, je treba dati en 0,5-mililitrski odmerek oziroma dva poživitvena odmerka, kadar gre za bolnike z oslabljenim imunskim sistemom (naravnim obrambnim mehanizmom telesa), pri čemer je drugi odmerek treba dati najmanj 28 dni po prvem.
What are the risks associated with Imvanex? 
Kakšna tveganja so povezana z zdravilom Imvanex?
Imvanex is a vaccine used to protect against smallpox in adults. 
Zdravilo Imvanex je cepivo, ki se uporablja za zaščito odraslih pred črnimi kozami.
What information is still awaited for Imvanex? 
Katere informacije o zdravilu Imvanex še pričakujemo?
The European Medicines Agency considered that Imvanex is effective at triggering the production of antibodies against smallpox to a level that provides protection at least as high as that from conventional smallpox vaccines. 
Evropska agencija za zdravila je menila, da zdravilo Imvanex učinkovito sproži tvorjenje protiteles proti črnim kozam in da je njihova koncentracija dovolj visoka, da zagotavlja vsaj tolikšno zaščito kot običajna cepiva proti črnim kozam.
Imvanex was shown in studies to be effective at triggering the production of antibodies to a level expected to provide protection against smallpox. 
Študije so pokazale, da zdravilo Imvanex učinkovito sproži tvorjenje protiteles v koncentracijah, ki naj bi zagotavljale zaščito pred črnimi kozami.
How does Imvanex work? 
Kako zdravilo Imvanex deluje?
Because of its similarity to the smallpox virus, antibodies produced against this virus are also expected to protect against smallpox. 
Ker je podoben virusu črnih koz, naj bi protitelesa, ki se tvorijo proti virusu vakcinija Ankara, ščitila tudi pred virusom črnih koz.
This is because it has not been possible to obtain complete information about Imvanex due to the rarity of the disease. 
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
Imvanex is given by injection under the skin, preferably in the upper arm. People who have not been previously vaccinated against smallpox should receive two 0.5 ml doses, with the second dose given at least 28 days after the first. 
Posamezniki, ki še niso bili cepljeni proti črnim kozam, morajo prejeti dva odmerka po 0,5 ml, pri čemer je drugi odmerek treba dati najmanj 28 dni po prvem.
How is Imvanex used? 
Kako se zdravilo Imvanex uporablja?
• Bioequivalence vis-à-vis an EU reference medicinal product has been demonstrated, based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product). 
• Biološka enakovrednost z referenčnim zdravilom, odobrenim v EU, je bila dokazana z ustreznimi podatki v skladu z zahtevami člena 10 Direktive 2001/83/ES (npr. primerjalne študije biološke enakovrednosti z referenčnim zdravilom, odobrenim v EU).
For the suspension of the marketing authorisations referred to in annex IB to be lifted, the competent authorities of the EU Member States shall ensure that the below condition has been completed by the marketing authorisation holder(s) 
Za preklic začasnega umika dovoljenj za promet z zdravilom, navedenih v Prilogi IB, morajo pristojni organi držav članic Evropske unije zagotoviti, da je/so imetnik(-i) dovoljenj(a) za promet z zdravilom izpolnil(-i) naslednji pogoj:
Annex III Condition for lifting the suspension of the marketing authorisations 
Priloga III
It is available as tablets (15, 30 and 45 mg). 
Na voljo je v obliki tablet (15, 30 in 45 mg).
The tablets should be swallowed with water. 
Tablete je treba pogoltniti z vodo.
The European Commission granted a marketing authorisation valid throughout the European Union for Sepioglin on 9 March 2012. 
Evropska komisija je dovoljenje za promet z zdravilom Sepioglin, veljavno po vsej Evropski uniji, odobrila dne 9. marca 2012.
The full EPAR for Sepioglin 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 Sepioglin je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What are the benefits and risks of Sepioglin? 
Kakšne so koristi in tveganja, povezani z zdravilom Sepioglin?
Treatment with Sepioglin should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit. 
Zdravljenje z zdravilom Sepioglin je treba ponovno oceniti po treh do šest mesecih in ga pri bolnikih, ki od njega nimajo zadostne koristi, prekiniti.
This means that Sepioglin is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Actos.