FrancophonIA/ELRC3.0 huggingface dataset:
English: Urinary recovery of the parent medicinal product is limited to less than 1% within the 24 hours post dose.
Slovenian: 24 ur po odmerku je v urinu prisotno manj kot 1 % izhodiščnega zdravila.
English: Platelet counts returned to normal when treatment was stopped but dropped to even lower levels when inotersen aministration was resumed.
Slovenian: Število trombocitov se je ob prekinitvi zdravljenja vrnilo v normalno območje, vendar se je po ponovnem odmerjanju inotersena zmanjšalo na še nižje vrednosti.
English: If the solution is cloudy or contains visible particulate matter, the contents must not be injected.
Slovenian: Raztopine, ki je motna ali vsebuje vidne delce, se ne sme injicirati.
English: There are no or limited amount of data from the use of inotersen in pregnant women.
Slovenian: Podatkov o uporabi inotersena pri nosečnicah ni oziroma so omejeni.
English: However, increasing vitamin A supplementation to above 3000 IU per day during pregnancy is unlikely to correct plasma retinol levels due to the mechanism of action of inotersen and may be harmful to the mother and foetus.
Slovenian: Vendar pa zaradi mehanizma delovanja inotersena ni verjetno, da bi povečanje vnosa vitamina A nad 3000 i.e. dnevno med nosečnostjo popravilo koncentracijo retinola v plazmi, poleg tega je lahko škodljivo za mater in zarodek.
English: A population pharmacokinetic analysis suggests that mild and moderate renal impairment has no clinically relevant effect on the systemic exposure of inotersen.
Slovenian: Populacijska farmakokinetična analiza kaže, da blaga ali zmerna okvara ledvic nima klinično pomembnega vpliva na sistemsko izpostavljenost inotersenu.
English: If you stop taking Tegsedi then your blood levels should be checked 8 weeks after discontinuation.
Slovenian: Če prenehate jemati zdravilo Tegsedi, je treba ravni v krvi preveriti 8 tednov po prekinitvi zdravljenja.
English: Orthostatic hypotension Hypotension Haematoma
Slovenian: Žilne bolezni ortostatska hipotenzija hipotenzija hematom
English: Inotersen should not be used in patients with a urine protein to creatinine ratio (UPCR) ≥ 113 mg/mmol (1 g/g) or estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m2 (see section 4.3).
Slovenian: Inotersena se ne sme uporabljati pri bolnikih z razmerjem med beljakovinami in kreatininom v urinu (UPCR) ≥ 113 mg/mmol (1 g/g) ali ocenjeno hitrostjo glomerulne filtracije (eGFR) < 45 ml/min/1,73 m
English: Three (3%) patients developed platelet counts < 25 x 10
Slovenian: Trije (3 %) bolniki so imeli število trombocitov < 25 x 10
English: • To carry the card with them at all times during the treatment and up to 8 weeks following treatment discontinuation;
Slovenian: • da morajo ves čas zdravljenja in do 8 tednov po prekinitvi zdravljenja imeti to kartico pri sebi;
English: Pack sizes of 1 or 4 pre-filled syringes.
Slovenian: Pakiranja z 1 ali 4 napolnjenimi injekcijskimi brizgami.
English: Hepatic enzymes should be measured 4 months after initiation of treatment with inotersen and annually thereafter or more frequently as clinically indicated, in order to detect cases of hepatic impairment (see section 4.8).
Slovenian: Za odkrivanje primerov okvare jeter je treba preveriti ravni jetrnih encimov 4 mesece po začetku zdravljenja z zdravilom Tegsedi, pozneje pa letno ali pogosteje, če je klinično indicirano (glejte poglavje 4.8).
English: If you are a woman of child-bearing age, you should practise effective contraception and any pregnancy should be excluded before starting the treatment with Tegsedi.
Slovenian: Če ste ženska v rodni dobi, morate uporabljati učinkovito kontracepcijo, pred začetkom zdravljenja z zdravilom Tegsedi pa je treba izključiti nosečnost.
English: Read the Instructions for Use before you start using your pre-filled syringe and each time you get a repeat prescription.
Slovenian: Preden začnete uporabljati napolnjeno injekcijsko brizgo in vsakič, ko prejmete ponoven recept, preberite navodilo za uporabo.
English: Therefore, pregnancy should be excluded before treatment initiation and women of childbearing potential should practise effective contraception (see section 4.6).
Slovenian: Zato je treba pred začetkom zdravljenja nosečnost izključiti, ženske v rodni dobi pa morajo uporabljati učinkovito kontracepcijo (glejte poglavje 4.6).
English: The high volume of distribution suggests inotersen extensively distributes into tissues following SC administration.
Slovenian: Velik volumen porazdelitve nakazuje, da se inotersen po subkutanem dajanju obsežno porazdeli v tkiva.
English: Hold the pre-filled syringe by the body, with the needle facing away from you.
Slovenian: Držite telo napolnjene injekcijske brizge, tako da je igla obrnjena proč od vas.
English: Call for immediate help if you have stiffness of the neck or an unusual and severe headache because these symptoms may be caused by bleeding in the brain.
Slovenian: Če imate tog vrat ali nenavadne in hude glavobole, potrebujete takojšnjo zdravniško pomoč, ker lahko te simptome povzroči krvavitev v možganih.
English: If you forget to use Tegsedi
Slovenian: Če ste pozabili uporabiti zdravilo Tegsedi
English: If you are planning to become pregnant you should stop taking inotersen including vitamin A supplementation and ensure that your vitamin A levels have returned to normal before conception is attempted.
Slovenian: Če nameravate zanositi, morate prenehati jemati inotersen ter z dodatke vitamina A ter se prepričati, da so se ravni vitamina A vrnile na normalno raven, preden poskusite zanositi.
English: INFORMATION IN BRAILLE Tegsedi
Slovenian: PODATKI V BRAILLOVI PISAVI Tegsedi
English: There is no information available on the effects of inotersen on human fertility.
Slovenian: Podatkov o vplivu inotersena na plodnost pri ljudeh ni na voljo.
English: Inotersen is not primarily cleared by metabolism in the liver, not a substrate for CYP450 oxidation, and metabolized broadly by nucleases in all tissues of distribution.
Slovenian: Jetrna presnova ni glavna pot očistka inotersena, inotersen ni substrat za oksidacijo s citokromom CYP450 in v vseh tkivih, kamor se porazdeli, ga večinoma presnavljajo nukleaze.
English: Patients should be instructed to report to their physician immediately if they experience any signs of unusual or prolonged bleeding (e.g. petechia, spontaneous bruising, subconjunctival bleeding, nosebleeds), neck stiffness or atypical severe headache.
Slovenian: Bolnikom je treba naročiti, naj nemudoma obvestijo svojega zdravnika, če se pojavijo nenavadne ali dolgotrajne krvavitve (npr. petehije, spontane podplutbe, subkonjuktivalna krvavitev, krvavitve iz nosu), togost vratu ali atipičen močan glavobol.
English: If any of the above happens, throw away the pre-filled syringe in a puncture-resistant (sharps) container and use a new pre-filled syringe.
Slovenian: Če se zgodi kaj od naštetega, zavrzite napolnjeno injekcijsko brizgo v vsebnik za ostre predmete (odporen proti vbodom), in uporabite novo napolnjeno injekcijsko brizgo.
English: You should consult your doctor if you should either stop breastfeeding or stop the treatment with Tegsedi.
Slovenian: Morate se posvetovati z zdravnikom o tem, ali boste prenehali dojiti ali prenehali uporabljati zdravilo Tegsedi.
English: You should either gently pinch the skin at the injection site or give the injection without pinching the skin.
Slovenian: Kožo na mestu injiciranja lahko nežno uščipnete ali pa injicirate zdravilo, ne da bi opravili ta korak.
English: Tegsedi is indicated for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).
Slovenian: Zdravilo Tegsedi je indicirano za zdravljenje polinevropatije 1. ali 2. stopnje pri odraslih bolnikih z dedno transtiretinsko amiloidozo (hATTR - hereditary Trasnthyretin Amyloidosis).
English: You should not use Tegsedi if you are pregnant, unless explicitly advised by your doctor.
Slovenian: Če ste noseči, ne smete uporabljati zdravila Tegsedi, razen če vam to izrecno svetuje zdravnik.
English: Start the injection
Slovenian: Začnite injiciranje
English: If you miss your dose of Tegsedi, then you should have your next dose as soon as possible, unless the next scheduled dose is within two days, in which case the missed dose should be skipped and the next dose given at the scheduled time.
Slovenian: Če ste pozabili uporabiti odmerek zdravila Tegsedi, morate uporabiti naslednji odmerek čim prej, razen če je naslednji odmerek načrtovan v naslednjih dveh dneh - v tem primeru izpustite pozabljeni odmerek in uporabite naslednjega ob predvidenem času.
English: Choose an injection site on your abdomen (belly) or the front of your thigh.
Slovenian: Izberite mesto injiciranja na trebuhu ali sprednji strani stegna.
English: Special caution should be used in elderly patients, in patients taking anithrombotic medicinal products, antiplatelet medicinal products, or medicinal products that may lower platelet count (see section 4.5), and in patients with prior history of major bleeding events.
Slovenian: Posebna previdnost je potrebna pri starejših bolnikih, bolnikih, ki jemljejo antitrombotična zdravila, antiagregacijska zdravila in zdravila, ki lahko zmanjšajo število trombocitov (glejte poglavje 4.5), ter bolnikih z večjimi krvavitvami v anamnezi.
English: Stage 2
Slovenian: 2. stadij
English: If you are using any medicines that damage the kidney or affect kidney function, for example sulfonamides, aldosterone antagonists, and some types of painkillers, you should tell your doctor.
Slovenian: Če uporabljate katero koli zdravilo, ki poškoduje ledvice ali vpliva na delovanje ledvic, na primer sulfonamide, antagoniste aldosterona in nekatere vrste zdravil za lajšanje bolečin, morate o tem obvestiti svojega zdravnika.
English: Prepare to use your pre-filled syringe
Slovenian: Pripravite se na uporabo napolnjene injekcijske brizge
English: No recommendation can be given whether to continue or discontinue vitamin A supplementation during the first trimester of an unplanned pregnancy.
Slovenian: Ni mogoče dati priporočila, ali je treba v prvem trimesečju nenačrtovane nosečnosti dodajanje vitamina A prekiniti ali nadaljevati.
English: Inotersen must not be used in patients with severe hepatic impairment (see section 4.3).
Slovenian: Inotersena se ne sme uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
English: Baseline demographics
Slovenian: Izhodiščni demografski podatki
English: If you have problems with your sight or any other eye problems when you are using Tegsedi, you should speak to your doctor.
Slovenian: Če imate med uporabo zdravila Tegsedi težave z vidom ali kakšne druge težave z očmi, se posvetujte s svojim zdravnikom.
English: Transient increases of CRP and platelet levels may occur in some patients after initiation of inotersen.
Slovenian: Pri nekaterih bolnikih se lahko po uvedbi inotersena pojavijo prehodna zvišanja ravni CRP in trombocitov.
English: P-value n (Placebo, Inotersen)
Slovenian: Vrednost P n (placebo, inotersen)
English: Slowly lift up on the plunger and let the safety spring push the plunger up automatically.
Slovenian: Počasi dvignite prst, s katerim pritiskate bat, in pustite, da varnostna vzmet samodejno potisne bat navzgor.
English: Contact your doctor or pharmacist, or go to a hospital emergency department immediately, even if you have no symptoms.
Slovenian: Če ste uporabili večji odmerek zdravila Tegsedi, kot bi smeli Nemudoma se posvetujte z zdravnikom ali farmacevtom ali pojdite do ambulante za nujno medicinsko pomoč, tudi če nimate nikakršnih simptomov.
English: The kidney accumulation of inotersen was associated with proteinuria in rats at 13.4-fold the human AUC at the recommended therapeutic inotersen dose.
Slovenian: Kopičenje inotersena v ledvicah je bilo pri podganah povezano s proteinurijo pri 13,4-krat višji vrednosti AUC, kot bi jo pri ljudeh dosegli s priporočenim terapevtskim odmerkom inotersena.
English: Choose the injection site
Slovenian: Izberite mesto injiciranja
English: Caution should be exercised with concomitant use of nephrotoxic medicinal products and other medicines that may impair renal function, such as sulfonamides, aldosterone antagonists, anilides, natural opium alkaloids and other opiods (see section 4.4).
Slovenian: Previdno je treba sočasno uporabljati tudi nefrotoksična zdravila in druga zdravila, ki lahko poslabšajo delovanje ledvic, kot so sulfonamidi, antagonisti aldosterona, anilidi, naravni alkaloidi opija in drugi opiati (glejte poglavje 4.4).
English: How to store Tegsedi 6.
Slovenian: Kako uporabljati zdravilo Tegsedi 4.
English: • Advise HCPs that if the platelet count falls below 25 x 109/L, Tegsedi treatment should be permanently discontinued and corticosteroid therapy is recommended;
Slovenian: • svetovati zdravstvenim delavcem, da je treba, če se število trombocitov zmanjša pod 25 x 109/l, zdravljenje z zdravilom Tegsedi trajno prekiniti in da se v takem primeru svetuje zdravljenje s kortikosteroidi;
English: If a woman intends to become pregnant, inotersen and vitamin A supplementation should be discontinued and plasma vitamin A levels should be monitored and have returned to normal before conception is attempted.
Slovenian: Če ženska želi zanositi, je treba zdravljenje z inotersenom in dodajanje vitamina A prekineti, ravni vitamina A v plazmi pa spremljati in počakati, da se vrnejo v normalni razpon pred poskusom zanositve.
English: If a dose of inotersen is missed, then the next dose should be administered as soon as possible, unless the next scheduled dose is within two days, in which case the missed dose should be skipped and the next dose administered as scheduled.
Slovenian: Ob izpustitvi odmerka inotersena je treba naslednji odmerek uporabiti čim prej, razen če je naslednji odmerek načrtovan v dveh dneh - v tem primeru je treba izpuščeni odmerek preskočiti in uporabiti naslednji odmerek skladno z načrtovanim odmerjanjem.
English: If acute glomerulonephritis is confirmed, permanent discontinuation of the treatment should be considered.
Slovenian: Če se potrdi akutni glomerulonefritis, je treba razmisliti o trajni opustitvi zdravljenja.
English: Patients and/or caregivers should be trained in the subcutaneous administration of Tegsedi.
Slovenian: Bolniki in/ali negovalci morajo biti usposobljeni za subkutano dajanje zdravila Tegsedi.
English: In the event of an unplanned pregnancy, inotersen should be discontinued.
Slovenian: Če pride do nenačrtovane nosečnosti, je treba zdravljenje z inotersenom prekiniti.
English: 1.5 mL solution in a clear Type 1 glass pre-filled syringe.
Slovenian: 1,5 ml raztopine v napolnjeni injekcijski brizgi iz prosojnega stekla tipa 1.
English: NAME OF THE MEDICINAL PRODUCT Tegsedi 284 mg solution for injection in pre-filled syringe inotersen NAME OF THE MARKETING AUTHORIZATION HOLDER Akcea Therapeutics EXPIRY DATE
Slovenian: IME ZDRAVILA Tegsedi 284 mg raztopina za injiciranje v napolnjeni injekcijski brizgi inotersen IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Akcea Therapeutics DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: For this reason, pregnancy should be excluded before initiation of inotersen therapy and women of child-bearing potential should practise effective contraception.
Slovenian: Zato je treba nosečnost izključiti začetkom zdravljenja z inotersenom, ženske v rodni dobi pa morajo uporabljati učinkovito kontracepcijo.
English: Clean the injection site with an alcohol wipe in a circular motion.
Slovenian: S krožnimi gibi očistite mesto injiciranja z alkoholnim robčkom.
English: DISPOSAL AND CARE Dispose of the used pre-filled syringe
Slovenian: ODLAGANJE PRIPOMOČKA IN SKRB ZANJ Uporabljeno napolnjeno injekcijsko brizgo zavrzite
English: Extensive and persistent uptake of inotersen was observed by various cell types in multiple organs of all tested animal species including monocytes/macrophages, kidney proximal tubular epithelia, Kupffer cells of the liver, and histiocytic cell infiltrates in lymph nodes and injection sites.
Slovenian: Pri različnih vrstah celic v več organih vseh preskušanih živalskih vrst, vključno z monociti/makrofagi, proksimalnim epitelijem ledvičnih tubulov, Kupfferjevimi celicami v jetrih in histiocitnimi celičnimi infiltrati v bezgavkah in na mestih injiciranja, so opazili obsežen in persistenten privzem inotersena.
English: • Advise HCPs that if glomerulonephritis is confirmed, Tegsedi treatment should be permanently discontinued and early initiation of immunosuppressive therapy should be considered.
Slovenian: • svetovati zdravstvenim delavcem, da je treba, če se potrdi glomerulonefritis, zdravljenje z zdravilom Tegsedi trajno prekiniti in razmisliti o zgodnji uvedbi zdravljenja z imunosupresivnimi zdravili.
English: Platelet count should be monitored every 2 weeks during treatment with inotersen and for 8 weeks following discontinuation of treatment.
Slovenian: Število trombocitov je treba spremljati na vsaka 2 tedna med zdravljenjem in še 8 tednov po prekinitvi zdravljenja.
English: Do not remove the needle cap until right before you inject.
Slovenian: Pokrovček igle odstranite šele tik pred injiciranjem.
English: Consider more frequent monitoring if additional risk factors for bleeding are present.
Slovenian: Če so prisotni dodatni dejavniki tveganja za krvavitev, bo morda potrebno pogostejše spremljanje.
English: If you let go of the plunger too quickly, you may lose some of the medicine.
Slovenian: Če bat prehitro spustite, se morda ne bo injicirala celotna količina zdravila.
English: Percent Change from Baseline in Serum TTR Over Time
Slovenian: Slika 1 Odstotna sprememba serumskih ravni TTR glede na izhodišče skozi čas
English: • Let the pre-filled syringe reach room temperature (20 °C to 25 °C) for 30 minutes before injecting it. Do not warm the pre-filled syringe in any other way.
Slovenian: • Pred injiciranjem počakajte 30 minut, da napolnjena injekcijska brizga doseže sobno temperaturo (od 20 do 25 °C).
English: Driving and using machines Use of Tegsedi has not been shown to affect ability to drive or use machinery.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni bilo videti, da bi uporaba zdravila Tegsedi vplivala na sposobnost vožnje ali upravljanja strojev.
English: Pull to open
Slovenian: Odprite s potegom
English: The plunger will start to lift automatically which means that the plunger has been pushed fully down.
Slovenian: Ko se bat samodejno začne dvigati, to pomeni, da ste ga pritisnili do konca navzdol.
English: Glomerulonephritis has occurred in patients treated with inotersen (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z inotersenom, se je pojavil glomerulonefritis (glejte poglavje 4.8).
English: What Tegsedi is and what it is used for
Slovenian: Kaj je zdravilo Tegsedi in za kaj ga uporabljamo
English: If you are taking any medicines that can lower platelet count or stop blood from clotting, for example acetylsalicylic acid, clopidogrel, warfarin, heparin, rivoraxaban and dabigatran, you must tell your doctor before you use Tegsedi.
Slovenian: Če jemljete katero koli zdravilo, ki lahko zmanjša število trombocitov ali preprečuje strjevanje krvi, na primer acetilsalicilno kislino, klopidogrel, varfarin, heparin, rivoraksaban in dabigatran, morate o tem obvestiti svojega zdravnika, preden uporabite zdravilo Tegsedi.
English: Tabulated summary of adverse reactions
Slovenian: Preglednica s povzetkom neželenih učinkov
English: It is, therefore, recommended that dosing of inotersen should be discontinued in subjects undergoing liver transplantation.
Slovenian: Zato je priporočljivo, da se odmerjanje inotersena opusti pri ljudeh, ki morajo prestati presaditev jeter.
English: It is important to rotate sites for injection.
Slovenian: Pomembno je, da se mesta injiciranja menjava.
English: What Tegsedi contains - The active substance is inotersen.
Slovenian: Kaj vsebuje zdravilo Tegsedi - Učinkovina je inotersen.
English: Liver Transplant Rejection
Slovenian: Zavrnitev presajenih jeter
English: It is normal to see air bubbles in the solution.
Slovenian: Prisotnost zračnih mehurčkov v raztopini je normalna.
English: In monkeys, perivascular cell infiltration by lymphohistiocytic cells in multiple organs was noted.
Slovenian: Pri opicah so v več organih opazili prodiranje limfohistiocitnih celic v perivaskularne celice.
English: Do not hold the pre-filled syringe by the plunger or push against the plunger to insert the needle.
Slovenian: Pri tem ne držite bata napolnjene injekcijske brizge in ne pritiskajte bata, da bi vstavili iglo.
English: Decreased platelet counts were observed in chronic toxicity studies in mice, rats and monkeys at 1.4 to 2-fold the human AUC at the recommended therapeutic inotersen dose.
Slovenian: V študijah toksičnosti kroničnega odmerjanja pri miših, podganah in opicah so opazili zmanjšano število trombocitov pri vrednosti AUC, ki ustreza od 1,4- do 2-kratni vrednosti AUC pri ljudeh, doseženi s priporočenim terapevtskim odmerkom inotersena.
English: Caution should be used with nephrotoxic medicinal products and other medicinal products that may impair renal function (see section 4.5).
Slovenian: Pri uporabi nefrotoksičnih zdravil in drugih zdravil, ki lahko poslabšajo delovanje ledvic, je potrebna previdnost (glejte poglavje 4.5).
English: Dose adjustment in case of reduction in platelet count Inotersen is associated with reductions in platelet count, which may result in thrombocytopenia.
Slovenian: Prilagoditev odmerka pri zmanjšanem številu trombocitov Inotersen je povezan z zmanjšanjem števila trombocitov, kar lahko povzroči trombocitopenijo.
English: Do not pull the plunger up by hand.
Slovenian: Bata ne skušajte povleči navzgor.
English: Plasma vitamin A (retinol) levels below lower limit of normal should be corrected and any ocular symptoms or signs of vitamin A deficiency should have resolved prior to initiation of inotersen.
Slovenian: Pred uvedbo zdravljenja z inotersenom je treba popraviti plazemske ravni vitamina A (retinola), ki so pod spodnjo normalno mejo, in vse morebitne očesne simptome ali znake pomanjkanja vitamina A.
English: Tegsedi is available in pack sizes of either 1 or 4 pre-filled syringes.
Slovenian: Zdravilo Tegsedi je na voljo v pakiranjih po 1 ali 4 napolnjene injekcijske brizge.
English: Inotersen has not been evaluated in patients undergoing liver transplant.
Slovenian: Inotersena niso ocenili pri bolnikih, ki so prestali presaditev jeter.
English: Consider corticosteroids if additional risk factors for bleeding are present.
Slovenian: Če so prisotni dodatni dejavniki tveganja za krvavitev, razmislite o uporabi kortikosteroidov.
English: • Remove the pre-filled syringe from the tray by holding onto the syringe body.
Slovenian: • Napolnjeno injekcijsko brizgo vzemite s podstavka tako, da primete telo brizge.
English: Tegsedi may reduce cells in the blood responsible for clotting of the blood (platelets), which may result in a condition called thrombocytopenia (see section 4).
Slovenian: Zdravilo Tegsedi lahko zmanjša število krvnih celic, odgovornih za strjevanje krvi (trombociti), kar lahko povzroči trombocitopenijo (glejte poglavje 4).
English: Table 2 presents the adverse reactions (ADRs) listed by MedDRA system organ class.
Slovenian: V preglednici 2 so neželeni učinki, razvrščeni po organskih sistemih glede na sistem MedDRA.
English: Still, no effect on embryo-foetal development was noted with a mouse-specific analogue of inotersen in mice, which was associated with ~60% inhibition (individual range up to 90% reduction) of TTR mRNA expression.
Slovenian: Toda tudi pri uporabi analoga inotersena, specifičnega za miši, ki je bil povezan s ~60odstotnim zaviranjem (individualno tudi do 90-odstotnim zmanjšanjem) izražanja mRNK za TTR še vedno ni bilo mogoče opaziti nobenih učinkov na embrio-fetalni razvoj pri miših.
English: Due to the prolonged activity of Tegsedi, however, your reduced vitamin A levels may persist.
Slovenian: Zaradi dolgotrajnega delovanja zdravila Tegsedi lahko zmanjšane ravni vitamina A vztrajajo.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Tegsedi 284 mg injection inotersen
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Tegsedi 284 mg, injekcija inotersen s.c.
English: Check medicine in the pre-filled syringe
Slovenian: Preverite zdravilo v napolnjeni injekcijski brizgi