FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use this medicine after the expiry date, which is stated on the tube label and box after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na tubi in škatli poleg oznake »EXP«.
English: The ratio of response and the 95% confidence interval in the ITT population were 1.226 (0.974-1.552) for CAILS and 1.017 (0.783-1.321) for SWAT and therefore consistent with those in the EE population for both the overall CAILS and SWAT responses.
Slovenian: Razmerje odzivov in 95-% interval zaupanja pri populaciji ITT sta bila 1,226 (0,974-1,552) za CAILS in 1,017 (0,783-1,321) za SWAT, tako da sta konsistentna s tistima pri populaciji EE za celotno vrednost odzivov po CAILS in SWAT.
English: Response rates (%)
Slovenian: Stopnja odziva (v %)
English: If reintroduction of treatment is tolerated for at least 1 week, the frequency of application can be increased to every other day for at least 1 week and then to once-daily application if tolerated.
Slovenian: Če bolnik nadaljevanje zdravljenja prenaša vsaj 1 teden, se lahko pogostnost nanašanja poveča na vsak drugi dan za vsaj 1 teden in nato na enkrat na dan, če bolnik to prenese.
English: • medical care should be obtained immediately (including ophthalmological consultation if there is eye exposure).
Slovenian: • takoj je treba poiskati medicinsko pomoč (vključno s posvetom z oftalmologom v primeru izpostavljenosti očesa).
English: - Contact with your eyes must be avoided.
Slovenian: - Stiku zdravila z očmi se je treba izogniti.
English: - Remove the cap from the tube just before use.
Slovenian: - Pokrovček s tube odstranite tik pred uporabo.
English: In the EE population, the percentage of patients who achieved a confirmed response by CAILS was similar between disease stages IA (79.6 %) and IB-IIA (73.2%).
Slovenian: Pri populaciji EE je bil odstotek bolnikov, ki so dosegli potrjeni odziv po CAILS, za stopnjo IA (79,6 %) in stopnjo IB-IIA (73,2 %) podoben.
English: If you apply more than recommended, talk to your doctor.
Slovenian: Če ste ga nanesli več, kot je priporočeno, se posvetujte z zdravnikom.
English: Study medicinal product was to be applied topically once daily for 12 months.
Slovenian: Zdravilo v preskušanju je bilo treba nanašati lokalno enkrat na dan 12 mesecev.
English: Comparator N=95
Slovenian: N = 95
English: - if you are allergic (hypersensitive) to chlormethine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični (preobčutljivi) na klormetin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: CAILS = Composite Assessment of Index Lesion Severity; CI = confidence interval; CR = Complete Response; PR = Partial Response; SWAT = Severity Weighted Assessment Tool.
Slovenian: CAILS = Sestavljena ocena indeksa resnosti poškodb; IZ = interval zaupanja; PO= popolni odziv; DO = delni odziv; SWAT = Orodje za ocenjevanje ovrednotene resnosti.
English: The tube should be returned to the refrigerator immediately after each use.
Slovenian: Tubo je treba spraviti v hladilnik takoj po vsaki uporabi.
English: Thus, the safety of the concomitant use of Ledaga with topical corticosteroids has not yet been established.
Slovenian: Zato varnost sočasne uporabe zdravila Ledaga in lokalnih kortikosteroidov še ni bila dokazana.
English: - Rash - Difficulty breathing
Slovenian: - težave pri dihanju.
English: The dosing recommendation for elderly patients ( ≥ 65 years old) is the same as for younger adult patients (see section 4.8).
Slovenian: Priporočilo za odmerjanje pri starostnikih (starih ≥ 65 let) je enako kot pri mlajših odraslih bolnikih (glejte poglavje 4.8).
English: The recommended application instructions should be followed (see section 4.2).
Slovenian: Upoštevati je treba priporočena navodila za nanašanje (glejte poglavje 4.2).
English: As the main secondary endpoint, patients were also evaluated using the Severity Weighted Assessment Tool (SWAT), which was based on an assessment of all lesions.
Slovenian: Kot glavni sekundarni opazovani dogodek so bolnike ocenili tudi z Orodjem za ocenjevanje ovrednotene resnosti (v nadaljevanju SWAT - Severity Weighted Assessment Tool), ki je temeljil na oceni vseh poškodb.
English: For dose modification information in case of skin reactions, see section 4.2.
Slovenian: Za informacijo o prilagajanju odmerka v primeru reakcij na koži glejte poglavje 4.2.
English: The CAILS score was adjusted by removal of the pigmentation score and simplification of the plaque elevation scale.
Slovenian: Ocena po CAILS je bila prilagojena z odstranitvijo ocene za pigmentacijo in poenostavitvijo lestvice za povečanje števila plakov.
English: Complete Response (CR) Partial Response (PR)
Slovenian: Popolni odziv (PO) Delni odziv (PR)
English: o Instruction on how to accurately use, open and dispose a plastic bag should be printed on the plastic bag.
Slovenian: o navodila o pravilni uporabi, odpiranju in odstranjevanju plastične vrečke morajo biti natisnjena na plastični vrečki.
English: Rinse the affected area right away for at least 15 minutes with large amounts of water, and seek medical assistance as soon as possible.
Slovenian: Takoj si vsaj 15 minut izpirajte prizadeti del z velikimi količinami vode in čim prej poiščite zdravniško pomoč.
English: - Caregivers must wear disposable nitrile gloves when applying this medicine to patients (this is a special type of glove; ask your doctor or pharmacist if you have questions).
Slovenian: - Negovalci morajo pri nanašanju zdravila Ledaga bolnikom nositi nitrilne rokavice za enkratno uporabo (to so rokavice posebne vrste; če imate vprašanja, se posvetujte z zdravnikom ali farmacevtom).
English: Chlormethine is a bifunctional alkylating agent that inhibits rapidly proliferating cells.
Slovenian: Klormetin je difunkcionalna alkilirajoča učinkovina, ki zavira hitro deleče se celice.
English: Dermal application of chlormethine to mice at a dose of 15 mg/kg for up to 33 weeks resulted in skin tumours (squamous cell carcinomas and skin papilloma).
Slovenian: Dermalna uporaba klormetina pri miših v odmerku 15 mg/kg do 33 tednov je povzročila kožne tumorje (karcinome skvamoznih celic in kožne papilome).
English: Ledaga N=90
Slovenian: Zdravilo Ledaga N = 90
English: Remove and wash contaminated clothing.
Slovenian: Onesnažena oblačila je treba odstraniti in oprati.
English: Upon improvement, treatment with Ledaga can be restarted at a reduced frequency of once every 3 days.
Slovenian: Ko se stanje izboljša, se lahko zdravljenje z zdravilom Ledaga nadaljuje z manjšo pogostnostjo, enkrat vsake 3 dni.
English: Other findings in animals included embryo-lethality and growth retardation when administered as a single injection.
Slovenian: Ostale ugotovitve pri živalih so vključevale smrtnost zarodkov in upočasnitev rasti pri dajanju v obliki enkratne injekcije.
English: The relevance to humans receiving topical chlormethine is unknown.
Slovenian: Pomen tega za ljudi, ki prejemajo lokalni klormetin, ni znan.
English: A complete response was defined as a confirmed CAILS score of 0.
Slovenian: Popolni odziv je bil opredeljen kot potrjena ocena 0 po CAILS.
English: What Ledaga is and what it is used for What you need to know before you use Ledaga How to use Ledaga
Slovenian: Kaj je zdravilo Ledaga in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ledaga Kako uporabljati zdravilo Ledaga
English: For storage conditions after defrosting Ledaga, see section 6.3.
Slovenian: Za pogoje shranjevanja po odmrzovanju zdravila Ledaga glejte poglavje 6.3.
English: Ledaga has no or negligible influence on the ability to drive or use machines.
Slovenian: Zdravilo Ledaga nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Do not apply the medicine near the eyes, to the inside of the nostrils, the inside of the ear or on the lips.
Slovenian: Zdravila ne nanašajte v bližini oči, v nosnicah, v ušesu ali na ustnice.
English: A response was defined as an at least 50% improvement in the baseline CAILS score, confirmed at a subsequent visit at least 4 weeks later.
Slovenian: Odziv je bil opredeljen kot vsaj 50-% izboljšanje glede na izhodiščno oceno po CAILS, potrjeno ob naknadnem obisku po vsaj 4 tednih.
English: This medicine is not expected to have any effect on your ability to drive or to use machines.
Slovenian: Ni pričakovati, da bo to zdravilo imelo kakršen koli vpliv na sposobnost upravljanja vozil in strojev.
English: The primary efficacy endpoint in Study 201 was the Composite Assessment of Index Lesion Severity (CAILS) response rate.
Slovenian: Primarni opazovani dogodek učinkovitosti v študiji 201 je bila stopnja odziva po Sestavljeni oceni indeksa resnosti poškodb (v nadaljevanju CAILS - Composite Assessment of Index Lesion Severity).
English: Blindness and severe irreversible anterior eye injury may occur.
Slovenian: Pride lahko do slepote in nepovratnih poškodb sprednjega dela očesa.
English: Patients should be monitored for development of skin cancers during and after discontinuation of treatment with chlormethine.
Slovenian: Bolnike je treba spremljati glede razvoja kožnega raka med zdravljenjem s klormetinom in po njem.
English: Frequencies were defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Slovenian: Pogostnost je bila opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000),
English: Ledaga is for use in adults only.
Slovenian: Zdravilo Ledaga se uporablja samo pri odraslih.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing severity.
Slovenian: V vsaki skupini pogostnosti so neželeni učinki navedeni po padajočem vrstnem redu resnosti.
English: Other medicines and Ledaga
Slovenian: Druga zdravila in zdravilo Ledaga
English: • The active substance is chlormethine.
Slovenian: • Učinkovina je klormetin.
English: Contents of the pack and other information What Ledaga contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ledaga
English: It is unknown whether chlormethine is excreted in human milk.
Slovenian: Ni znano, ali se klormetin izloča v materino mleko.
English: Table 1 CAILS and SWAT-confirmed response rates by 12 months in Study 201 (efficacy evaluable population)
Slovenian: Stopnje odziva, potrjene s CAILS in SWAT za dvanajst mesecev v študiji 201 (populacija EE)
English: A decision must be made whether to discontinue breast-feeding or to discontinue Ledaga therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the breastfeeding mother.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem zdravljenja z zdravilom Ledaga, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za doječo mater.
English: Chlormethine caused foetal malformations in mice and rats when given as single injections of 1-2.5 mg/kg.
Slovenian: Klormetin je povzročil malformacije plodov pri miših in podganah, ki so prejele enkratno injekcijo z odmerkom 1-2,5 mg/kg.
English: Unused refrigerated Ledaga should be discarded after 60 days, together with the plastic bag.
Slovenian: Neuporabljeno zdravilo Ledaga je treba po 60 dneh zavreči, skupaj s plastično vrečko.
English: It attaches to the DNA of dividing cells, like cancer cells, which stops them from multiplying and growing.
Slovenian: Pritrdi se na DNK delečih se celic, kot so rakave celice, zaradi česar se ne morejo več deliti in razraščati.
English: Patients were stratified based on stage (IA vs IB and IIA) and then randomised to receive either Ledaga (equivalent to 0.02% chlormethine HCl) or the comparator (a petroleum-based 0.02% chlormethine HCl ointment).
Slovenian: Bolniki so bili razdeljeni po stopnjah (IA v primerjavi z IB in IIA) in nato randomizirani za prejemanje zdravila Ledaga (enakovrednega 0,02 % klormetinijevega klorida) ali primerjalnega zdravila (mazila z 0,02 % klormetinijevega klorida na osnovi nafte).
English: Hypersensitivity to chlormethine or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na klormetin ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: After defrosting 60 days in the refrigerator (+2 °C to +8 °C).
Slovenian: Po odmrznjenju 60 dni v hladilniku (od +2 °C do +8 °C).
English: Skin-directed therapies for MF-type CTCL have been associated with secondary skin cancers, although the specific contribution of chlormethine has not been established.
Slovenian: Zdravljenja CTLC vrste MF na koži so povezana s sekundarnimi oblikami kožnega raka, čeprav specifični prispevek klormetina k temu še ni bil dokazan.
English: Get medical help right away if Ledaga gets into your eyes, mouth, or nose.
Slovenian: Takoj poiščite zdravniško pomoč, če zdravilo Ledaga dobite v oči, usta ali nos.
English: Ledaga is a clear, colourless gel.
Slovenian: Zdravilo Ledaga je bister brezbarvni gel.
English: Treatment with Ledaga should be initiated by an appropriately experienced physician.
Slovenian: Zdravljenje z zdravilom Ledaga sme uvesti zdravnik z ustreznimi izkušnjami.
English: Non-inferiority was considered to have been demonstrated if the lower bound of the 95% confidence interval around the ratio of response rates (Ledaga/comparator) was greater than or equal to 0.75.
Slovenian: Neinferiornost zdravljenja je bila opredeljena kot dokazana, če je bila spodnja meja 95-% intervala zaupanja po razmerju stopenj odziva (zdravilo Ledaga/primerjalno zdravilo) 0,75 ali več.
English: Chlormethine was shown to be genotoxic in bacterial, plant, and mammalian cells.
Slovenian: Ugotovljena je bila genotoksičnost klormetina za bakterijske, rastlinske in sesalske celice.
English: Each tube contains 10.5 grams of propylene glycol and 6 micrograms of butylhydroxytoluene.
Slovenian: Ena tuba vsebuje 10,5 gramov propilenglikola in 6 mikrogramov butilhidroksitoluena.
English: o The plastic bag should not be used for any other purposes and must be disposed after 60 days, together with unused refrigerated Ledaga and any waste material, including nitrile gloves in accordance with local requirements.
Slovenian: o Plastične vrečke ni dovoljeno uporabljati za druge namene in jo je treba po 60 dneh zavreči, skupaj z neuporabljenim zdravilom Ledaga, shranjenim v hladilniku, in vsakršnim drugim odpadnim materialom, vključno z nitrilnimi rokavicami, v skladu z lokalnimi predpisi.
English: Caregivers should remove gloves carefully (turning them inside out during the removal to avoid contact with Ledaga) and wash hands thoroughly with soap and water after removal of gloves.
Slovenian: Negovalci morajo rokavice sneti previdno (tako da jih med odstranjevanjem obrnejo navzven, da se izognejo stiku z zdravilom Ledaga) in si po odstranitvi rokavic roke dobro umiti z milom in vodo.
English: • Ledaga should be applied to completely dry skin at least 4 hours before or 30 minutes after showering or washing.
Slovenian: • Zdravilo Ledaga je treba nanesti na povsem suho kožo vsaj 4 ure pred ali 30 minut po tuširanju ali umivanju.
English: Contact with mucous membranes, especially those of the eyes, must be avoided.
Slovenian: Stiku s sluznicami, zlasti očesnimi, se je treba izogniti.
English: - If this medicine gets in your mouth or nose, it can cause pain, redness, and ulcers that may be severe.
Slovenian: - Če dobite to zdravilo v usta ali nos, lahko povzroči bolečino, pordelost in razjede, ki so lahko hude.
English: Ledaga is intended only for use on the skin.
Slovenian: Zdravilo Ledaga je namenjeno le za uporabo na koži.
English: If it is not, ask your pharmacist.
Slovenian: Če ni, se posvetujte s farmacevtom.
English: A partial response was defined as an at least 50% reduction in the baseline CAILS score.
Slovenian: Delni odziv je bil opredeljen kot vsaj 50-% zmanjšanje v izhodiščni oceni po CAILS.
English: If Ledaga gets in your eyes, rinse your eyes right away for at least 15 minutes with large amounts of water, a solution known as “0.9% sodium chloride solution” or an eye-wash solution, and seek medical assistance (including an eye doctor) as soon as possible.
Slovenian: Če dobite zdravilo Ledaga v oči, si jih takoj vsaj 15 minut izpirajte z velikimi količinami vode, raztopino, imenovano »0,9-% raztopina natrijevega klorida« ali z raztopino za izpiranje oči in čim prej poiščite zdravniško pomoč (tudi okulista).
English: Exposure of the eyes to chlormethine causes pain, burns, inflammation, photophobia, and blurred vision.
Slovenian: Izpostavljenost oči klormetinu povzroča bolečino, opekline, vnetje, fotofobijo in zamegljen vid.
English: Apply your next dose when it is due.
Slovenian: Naslednji odmerek uporabite,
English: - Skin cancers (abnormal growth of the cells in the skin) have been reported after application of chlormethine to the skin, although it is not known whether chlormethine causes this.
Slovenian: - Poročali so o pojavu več oblik kožnega raka (nenormalna rast celic v koži) po nanosu klormetina na kožo, čeprav ni znano, ali jih je povzročil klormetin.
English: Risks of secondary exposure may include skin reactions, mucosal injury, and skin cancers.
Slovenian: Tveganja zaradi sekundarne izpostavljenosti lahko vključujejo reakcije na koži, poškodbe sluznice in več oblik kožnega raka.
English: Pharmacotherapeutic group: Antineoplastic agents, nitrogen mustard analogues, ATC code: L01AA05.
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), analogi dušikovih iperitov, oznaka ATC: L01AA05.
English: The medicinal product contains propylene glycol and butylhydroxytoluene, which may cause skin irritation (e.g., contact dermatitis).
Slovenian: Zdravilo vsebuje propilenglikol in butilhidroksitoluen, ki lahko povzročita draženje kože (npr. kontaktni dermatitis).
English: Efficacy was evaluated in the Efficacy Evaluable (EE) population, which included all 185 patients who were treated for at least 6 months with no major protocol deviations [Table 1], and in the IntentTo-Treat (ITT) population, which included all 260 randomised patients.
Slovenian: Učinkovitost so ocenili pri populaciji, primerni za oceno učinkovitosti (v nadaljevanju EE - Efficacy Evaluable), ki je vključevala vseh 185 bolnikov, ki so bili zdravljeni vsaj 6 mesecev brez večjih odstopanj od protokola [Preglednica 1] in pri populaciji z namenom zdravljenja (v nadaljevanju ITT
English: EXP Discard 60 days after defrosting: ../../....
Slovenian: EXP Po 60 dneh po odmrzovanju zdravilo zavrzite.
English: Unopened tube 3 years in the freezer (-15 °C to -25 °C).
Slovenian: Neodprta tuba 3 leta v zamrzovalniku (od -15 °C do -25 °C).
English: Patients and caregivers must wash hands after handling Ledaga.
Slovenian: Bolniki in negovalci si morajo takoj po ravnanju z zdravilom Ledaga umiti roke.
English: Any unused medicinal product or waste material, including the plastic bag and the nitrile gloves used for application, must be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material, vključno s plastično vrečko in nitrilnimi rokavicami, uporabljenimi pri nanašanju, je treba zavreči v skladu z lokalnimi predpisi.
English: In addition, butylhydroxytoluene may also cause irritation to the eyes and mucous membranes (i.e., mouth and nose).
Slovenian: Butilhidroksitoluen lahko povzroči tudi draženje oči in sluznic (tj. ust in nosu).
English: Mucosal or eye exposure
Slovenian: Izpostavljenost sluznic ali oči
English: Risks of direct skin contact include inflammation of the skin (dermatitis), injury to their eyes, mouth, or nose, and skin cancers.
Slovenian: Tveganja zaradi neposrednega stika s kožo vključujejo vnetje kože (dermatitis), poškodbe oči, ust ali nosu in oblike kožnega raka.
English: This is an anti-cancer medicine used on the skin to treat mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL).
Slovenian: To je zdravilo za zdravljenje raka, ki ga uporabljamo na koži za zdravljenje kožnega T-celičnega limfoma vrste mycosis fungoides (CTLC vrste MF).
English: There is limited experience of chlormethine in pregnant women.
Slovenian: Izkušnje z uporabo klormetina pri nosečnicah so omejene.
English: Tell your doctor if you get any new damaged areas or ulcers on your skin.
Slovenian: Zdravniku povejte, če na koži opazite kakršne koli nove poškodovane dele ali razjede.
English: Ledaga contains alcohol and is therefore considered flammable.
Slovenian: Zdravilo Ledaga vsebuje alkohol in je zato vnetljivo.
English: • Ledaga should be supplied with a transparent, sealable, child-resistant plastic bag to prevent secondary exposure and contamination when Ledaga is stored in the refrigerator:
Slovenian: • Zdravilo Ledaga je treba dobaviti v prozorni plastični vrečki, ki jo je mogoče zapreti in je varna za otroke, da se prepreči sekundarna izpostavljenost in onesnaženje ob shranjevanju zdravila v hladilnik:
English: Adverse reactions reported with Ledaga in an active-controlled trial in patients with MF-type CTCL are shown below.
Slovenian: Neželeni učinki zdravila Ledaga, o katerih so poročali v preskušanju, nadzorovanem z učinkovino, pri bolnikih s CTLC vrste MF, so navedeni spodaj.
English: After defrosting, store in a refrigerator.
Slovenian: Po odmrzovanju shranjujte v hladilniku.
English: Recommended application instructions should be followed to prevent secondary exposure (see section 4.2).
Slovenian: Za preprečevanje sekundarne izpostavljenosti je treba upoštevati navodila za nanašanje (glejte poglavje 4.2).
English: The following instructions should be followed by patients or caregivers when applying Ledaga:
Slovenian: Bolniki ali negovalci morajo pri nanašanju zdravila Ledaga upoštevati naslednja navodila.
English: - Apply a thin layer of this medicine to completely dry skin at least 4 hours before or 30 minutes after showering or washing.
Slovenian: - Tanko plast tega zdravila nanesite na povsem suho kožo vsaj 4 ure pred tuširanjem ali umivanju ali 30 minut po tem.
English: Therefore, the use of this medicine is not recommended during pregnancy and in women of childbearing age not using contraception.
Slovenian: Zato uporaba zdravila Ledaga ni priporočljiva pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: There are limited data from the use of chlormethine in pregnant women.
Slovenian: Podatki o uporabi klormetina pri nosečnicah so omejeni.
English: • Ledaga should be applied immediately or within 30 minutes after removal from the refrigerator.
Slovenian: • Zdravilo Ledaga je treba nanesti takoj ali v 30 minutah po odvzemu iz hladilnika.
English: Return it to the refrigerator after each use.
Slovenian: Po vsaki uporabi ga spravite v hladilnik.
English: Dispose of the tube, plastic bag and nitrile gloves in accordance with local requirements.
Slovenian: Tubo, plastično vrečko in nitrilne rokavice je treba zavreči v skladu z lokalnimi predpisi.
English: Patients were not required to be refractory to or intolerant of prior therapies.
Slovenian: Odpornost ali intoleranca na predhodna zdravljenja ni bila zahtevana za vključitev v preskušanje.
English: Store in a refrigerator (+2 °C to +8 °C) at all times, ensuring the tube is in the box inside the childresistant, transparent, sealable, plastic bag.
Slovenian: Shranjujte v hladilniku (+2 °C do +8 °C) ves čas in poskrbite, da bo tuba spravljena v škatli v prozorni, za otroke varni plastični vrečki, ki jo je mogoče zapreti.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of European Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)