FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will ask you to take a daily vitamin A supplement during treatment with Tegsedi.
Slovenian: Zdravnik vam bo naročil, da morate med zdravljenjem z zdravilom Tegsedi vsak dan jemati dopolnilo vitamina A.
English: Inotersen is associated with reductions in platelet count, which may result in thrombocytopenia (see section 4.8).
Slovenian: Inotersen je povezan z zmanjšanjem števila trombocitov, kar lahko povzroči trombocitopenijo (glejte poglavje 4.8).
English: Patients should be monitored for signs of increased proteinuria and reduction in eGFR during treatment with inotersen (see section 4.4).
Slovenian: Bolnike je treba med zdravljenjem z inotersenom spremljati zaradi znakov povečane proteinurije in zmanjšanja vrednosti eGFR (glejte poglavje 4.4).
English: Therefore women of child-bearing age should exclude any pregnancy, before treatment initiation with Tegsedi and should practise effective contraception (see section “Pregnancy and breast-feeding” below).
Slovenian: Zato morajo ženske v rodni dobi morajo pred začetkom zdravljenja z zdravilom Tegsedi izključiti nosečnost in uporabljato učinkovito kontracepcijo (glejte poglavje »Nosečnost in dojenje« spodaj).
English: OTHER Subcutaneous use
Slovenian: DRUGI PODATKI Subkutana uporaba
English: Acute kidney injury Renal impairment
Slovenian: Pogosti odpoved ledvic akutna poškodba ledvic okvara ledvic
English: If you stop taking Tegsedi then your kidney function should be checked 8 weeks after discontinuation.
Slovenian: Če prenehate jemati zdravilo Tegsedi, je treba delovanje ledvic preveriti 8 tednov po prekinitvi zdravljenja.
English: The injection site may also be on the outer area of the upper arm if Tegsedi is administered by a caregiver.
Slovenian: Mesto injiciranja je lahko tudi na zunanjem delu nadlakti, če vam zdravilo Tegsedi daje negovalec.
English: Cases of liver transplant rejection have been reported in patients treated with Inotersen.
Slovenian: Poročali o primerih zavrnitve presajenih jeter pri bolnikih zdravljenih z inotersenom.
English: (eosinophilia) - Decreased appetite - Feeling faint or dizzy, especially on standing up (low blood pressure,
Slovenian: - povečanje števila belih krvnih celic, imenovanih eozinofilci, v krvi (eozinofilija) - zmanjšan apetit - občutek omotice ali vrtoglavice, zlasti ob vstajanju (nizek krvni tlak,
English: Do not remove any air bubbles from the pre-filled syringe.
Slovenian: Iz napolnjene brizge ne skušajte odstraniti zračnih mehurčkov.
English: If you have an unplanned pregnancy you should stop taking inotersen.
Slovenian: Če nenačrtovano zanosite, morate prenehati jemati inotersen.
English: Elderly No dose adjustment is required in patients aged 65 and over (see section 5.2).
Slovenian: Starejši bolniki Pri bolnikih, starih 65 let ali več, prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
English: Inotersen is associated with reductions in platelet count, which may result in thrombocytopenia.
Slovenian: Inotersen je povezan z zmanjšanjem števila trombocitov, kar lahko povzroči trombocitopenijo.
English: Patients should be monitored for signs and symptoms of transplant rejection during treatment with Inotersen.
Slovenian: Bolnike po presaditvi jeter je treba med zdravljenjem z inotersenom nadzorovati glede znakov in simptomov zavrnitve presadka.
English: Harcourt Centre, Harcourt Road Dublin 2, Ireland
Slovenian: Akcea Therapeutics Ireland Ltd Harcourt Centre, Harcourt Road Dublin 2 D02 HW77
English: In addition, reduced thymus weight due to lymphocyte depletion was observed in mice and rats.
Slovenian: Poleg tega so pri miših in podganah opazili zmanjšano maso timusa zaradi znižanih ravni limfocitov.
English: If the solution looks cloudy, discoloured or has particles, throw the pre-filled syringe away in a puncture resistant (sharps) container, and use a new pre-filled syringe.
Slovenian: Če je raztopina motna, ima drugačno barvo ali vsebuje delce, zavrzite napolnjeno injekcijsko brizgo v vsebnik za ostre predmete in uporabite novo napolnjeno injekcijsko brizgo.
English: Do not pull the cap off while holding the pre-filled syringe by the plunger.
Slovenian: Pokrovčka ne odstranite, medtem ko držite napolnjeno injekcijsko brizgo za bat.
English: Inotersen monitoring and treatment recommendations for platelet count Platelet count (x109/L)
Slovenian: Priporočila za spremljanje in zdravljenje glede na število trombocitov Število trombocitov (x 109/l) Pogostost spremljanja
English: In the Phase 3, NEURO-TTR trial, platelet count reductions to below normal (140 x 109/L ) were observed in 54% of patients treated with inotersen and 13% of placebo patients; reductions to below 100 x 10
Slovenian: V preskušanju 3. faze NEURO-TTR so pri 54 % bolnikov, ki so prejemali inotersen, in pri 13 % bolnikov, ki so dobivali placebo, opazili zmanjšanje števila trombocitov pod normalno mejo (140 x 10
English: Push firmly on the plunger at the end of the injection.
Slovenian: Ob koncu injiciranja močno pritisnite bat.
English: Make sure the needle stays fully inserted in the injection site while you are injecting the medicine.
Slovenian: Med injiciranjem zdravila pazite, da igla ostane popolnoma vstavljena na mesto injiciranja.
English: Tegsedi 284 mg solution for injection in pre-filled syringe inotersen
Slovenian: Tegsedi 284 mg raztopina za injiciranje v napolnjeni injekcijski brizgi inotersen
English: Patients who discontinue therapy with inotersen due to platelet counts below 25 x 10
Slovenian: Bolniki, ki prekinejo zdravljenje z inotersenom zaradi števila trombocitov, manjšega od 25 x 109/l, se ne smejo ponovno začeti zdraviti.
English: Do not pass it on to others.
Slovenian: Brizge ne delite z nikomer drugim in ne uporabite je ponovno.
English: Change from Baseline Inotersen - Placebo
Slovenian: Sprememba glede na izhodišče (inotersen - placebo)
English: Do not touch the area again before injecting.
Slovenian: Očiščenega predela se pred injiciranjem ne dotikajte več.
English: Caution should be used with anithrombotic medicinal products, antiplatelet medicinal products, and medicinal products that may lower platelet count, for example acetylsalicyclic acid, clopidogrel, warfarin, heparin, low-molecular weight heparins, Factor Xa inhibitors such as rivaroxaban and apixaban, and thrombin inhibitors such as dabigatran (see section 4.4).
Slovenian: Pri uporabi antitrombotičnih zdravil, antiagregacijskih zdravil in zdravil, ki lahko zmanjšajo število trombocitov, na primer acetilsalicilne kisline, klopidogrela, varfarina, heparina, heparina z nizko molekulsko maso, zaviralcev faktorja Xa, kot sta rivaroksaban in apiksaban, ter zaviralcev trombina, kot je dabigatran, je potrebna previdnost (glejte poglavje 4.4).
English: Do not throw away the pre-filled syringe in your household waste.
Slovenian: Napolnjene injekcijske brizge ne smete zavreči med navadne gospodinjske odpadke.
English: Your doctor will monitor you regularly for this during treatment with Tegsedi.
Slovenian: Zato vas bo zdravnik redno spremljal med zdravljenjem z zdravilom Tegsedi.
English: Platelet count, estimated glomerular filtration rate (eGFR), urine protein to creatinine ratio (UPCR) and hepatic enzymes should be measured prior to treatment with Tegsedi.
Slovenian: Pred zdravljenjem z zdravilom Tegsedi je treba preveriti število trombocitov, ocenjeno hitrost glomerulne filtracije (eGFR), razmerje med beljakovinami in kreatininom v urinu (UPCR) ter jetrne encime.
English: Do not use if the solution looks cloudy, discoloured, or has particles.
Slovenian: Raztopine ne uporabite, če je videti motna, ima drugačno barvo ali vsebuje delce.
English: Severe platelet declines in association with increased bleeding or bruising were observed in individual monkeys.
Slovenian: Pri posameznih opicah so opazili hudo zmanjšanje števila trombocitov v povezavi s povečanjem krvavitev ali nastajanja podplutb.
English: Glomerulonephritis Proteinuria Renal failure
Slovenian: Bolezni sečil glomerulonefritis proteinurija
English: (haematoma) - Itching - Rash - Kidney damage leading to poor kidney function or kidney failure - Changes to your blood and urine test results (this may indicate infection or liver or kidney damage) - Flu like symptoms, such as high temperature, aches and chills (influenza-like illness) - Injection site swelling or skin discolouration
Slovenian: hipotenzija) - podplutbe - nabiranje krvi v tkivih, kar je lahko podobno hudim podplutbam (hematom) - srbenje - izpuščaj - poškodba ledvic, ki povzroči slabo delovanje ali odpoved ledvic - spremembe rezultatov preiskav krvi in urina (to lahko kaže okužbo ali okvaro jeter ali ledvic) - simptomi, podobni gripi, kot so visoka telesna temperatura, bolečine in mrazenje (bolezen, podobna gripi) - oteklina ali sprememba barve kože na mestu injiciranja
English: Inotersen is not a substrate for CYP450 metabolism, and is metabolised in tissues by endonucleases to form shorter inactive oligonucleotides that are the substrates for additional metabolism by exonucleases.
Slovenian: V tkivih se presnavlja z endonukleazami, pri čemer se oblikujejo krajši neaktivni oligonukleotidi, ki so substrati za dodatno presnovo z eksonukleazami.
English: Renal function decline has also been observed in a number of subjects without signs of glomerulonephritis (see section 4.8).
Slovenian: Opazili so tudi poslabšanje delovanja ledvic pri številnih bolnikih brez znakov glomerulonefritisa (glejte poglavje
English: Some patients treated with inotersen have developed this condition.
Slovenian: Ta bolezen se je razvila pri nekaterih bolnikih, ki so se zdravili z inoteresenom.
English: Do not let go of the plunger.
Slovenian: Pokrovčka ne sukajte.
English: What Tegsedi looks like and contents of the pack
Slovenian: Izgled zdravila Tegsedi in vsebina pakiranja
English: Unchanged inotersen is the predominant circulating component.
Slovenian: Prevladujoča komponenta v obtoku je nespremenjen inotersen.
English: Your doctor will check your blood for levels of platelets before treatment and regularly during treatment with Tegsedi.
Slovenian: Vaš zdravnik bo preveril vašo raven trombocitov pred zdravljenjem z zdravilom Tegsedi in preverjanje redno ponavljal med zdravljenjem.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 284 mg inotersen (as sodium).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 284 mg inotersena (v obliki natrijevega inotersenata).
English: Subjects with Stage 1 and Stage 2 hATTR-PN and an NIS ≥10 and ≤130 were recruited in the pivotal NEURO-TTR study.
Slovenian: V ključni študiji NEURO-TTR so sodelovali preskušanci v 1. in 2. stadiju hATTRPN ter z rezultatom na lestvici NIS ≥ 10 in ≤ 130.
English: - Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia) - Headache - Vomiting, or nausea (feeling sick) - Increase in body temperature - Feeling cold (chills) or shivering - Injection site pain, redness, itching or bruising - Swelling of the ankles, feet or fingers (peripheral oedema)
Slovenian: (anemija) - glavobol - bruhanje ali navzea (občutek slabosti) - zvišanje telesne temperature - mrazenje ali drgetanje - bolečina, rdečina, srbenje ali podplutbe na mestu injiciranja - oteklost gležnjev, stopal ali prstov (periferni edem)
English: - Each pre-filled syringe contains 284mg of inotersen.
Slovenian: - Ena napolnjena injekcijska brizga vsebuje 284 mg inotersena.
English: Both inotersen and its shorter oligonucleotide metabolites are excreted in human urine.
Slovenian: S človeškim urinom se izločajo inotersen in njegovi krajši oligonukleotidni presnovki.
English: Referral for ophthalmological assessment is recommended if patients develop ocular symptoms consistent with vitamin A deficiency, incuding: reduced night vision or night blindness, persistent dry eyes, eye inflammation, corneal inflammation or ulceration, corneal thickening, corneal perforation.
Slovenian: Bolniki, ki prejemajo inotersen, morajo peroralno jemati tudi približno 3.000 i.e. vitamina A dnevno, da se zmanjša potencialno tveganje za očesne toksične učinke zaradi pomanjkanja vitamina A. Bolnika je priporočljivo napotiti na oftalmološki pregled, če se pojavijo očesni simptomi, ki se ujemajo s pomanjkanjem vitamina A, vključno z naslednjimi: poslabšan nočni vid ali nočna slepota, persistentna suhost oči, vnetje oči, vnetje ali razjede roženice, zadebelitev roženice, perforacija roženice.
English: Press down again if the plunger does not start to lift automatically.
Slovenian: Če se bat ne začne samodejno dvigati, ga ponovno pritisnite navzdol.
English: Glomerulonephritis / kidney problems
Slovenian: Glomerulonefritis/težave z ledvicami
English: Tegsedi contains the active substance inotersen.
Slovenian: Zdravilo Tegsedi vsebuje učinkovino inotersen.
English: WARNINGS
Slovenian: OPOZORILA
English: Vomiting Nausea
Slovenian: Bolezni prebavil bruhanje navzea
English: - Any medicines that may alter your kidney function or may damage the kidneys, e.g., sulfonamides (used as an antibacterial), anilides (used to treat fever, aches and pains), aldosterone antagonists (used as a diuretic) and natural opium alkaloids and other opiods (used for treatment of pain).
Slovenian: - zdravila, ki preprečujejo krvne strdke ali zmanjšajo število trombocitov v krvi, npr. acetilsalicilna kislina, heparin, varfarin, klopidogrel, rivoraksaban in dabigatran; - katera koli zdravila, ki lahko spremenijo delovanje ledvic ali poškodujejo ledvice, npr. sulfonamidi (uporabljajo se kot protibakterijske učinkovine), anilidi (uporabljajo se za zdravljenje zvišane telesne temperature in bolečin), antagonisti aldosterona (uporabljajo se kot diuretiki) ter naravni alkaloidi opija in drugi opiati (uporabljajo se za lajšanje bolečin).
English: Inspection Area
Slovenian: Območje za preverjanje vsebine
English: If not used, should be discarded.
Slovenian: Če se zdravila v tem času ne uporabi, ga je treba zavreči.
English: Liver monitoring
Slovenian: Spremljanje delovanja jeter
English: Serious side effects If you get any of the following side effects, stop using Tegsedi and contact your doctor immediately: - Symptoms that could indicate glomerulonephritis, (where your kidneys do not work properly), such as foaming urine, pink or brown coloured urine, blood in the urine, or passing less urine than usual.
Slovenian: Resni neželeni učinki Če se pri vas pojavi kateri koli od naslednjih neželenih učinkov, prenehajte uporabljati zdravilo Tegsedi in se nemudoma posvetujte z zdravnikom: - simptomi, ki bi lahko pomenili glomerulonefritis (pri tej bolezni gre za nepravilno delovanje ledvic), kot so penjenje urina, rožnato ali rjavo obarvan urin, kri v urinu in manjša količina urina kot običajno; - simptomi, ki bi lahko nakazovali trombocitopenijo (pri kateri se kri ne strjuje), kot so nepojasnjene podplutbe ali drobne rdeče kožne lise (imenujejo se petehije), ureznine, ki ne prenehajo krvaveti ali se iz njih izloča tekočina, krvavitev iz dlesni ali nosu, kri v urinu ali blatu ali krvavitev v očesno beločnico.
English: Glomerulonephritis / renal function decline
Slovenian: Glomerulonefritis/poslabšanje delovanja ledvic
English: What you need to know before you use Tegsedi Do not use Tegsedi if: - you are allergic to inotersen or any of the other ingredients of this medicine (listed in section - tests show you have excessively low numbers of platelets, the cells in your blood which stick together helping it clot - tests of kidney function or protein in the urine show signs of severe kidney problems - you have severe reduction in liver function (hepatic impairment) Warnings and precautions Before you begin treatment with Tegsedi, your doctor will measure your blood cells, liver function, kidney function, and protein levels in your urine.
Slovenian: Ne uporabljajte zdravila Tegsedi: - če ste alergični na inotersen ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če preiskave kažejo, da imate izjemno nizko število trombocitov - krvnih celic, ki se zlepijo skupaj in pomagajo pri strjevanju krvi; - če preiskave delovanja ledvic ali beljakovin v urinu kažejo znake hudih težav z ledvicami; - če imate zelo zmanjšano delovanje jeter (okvaro jeter).
English: No dose adjustment is required for patients with mild or moderate renal impairment (see section 5.2).
Slovenian: Pri bolnikih z blago ali zmerno okvaro ledvic prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
English: Patients should be monitored for thrombocytopenia during treatment with inotersen (see section 4.4).
Slovenian: Bolnike je treba med zdravljenjem z inotersenom spremljati zaradi možnosti trombocitopenije (glejte poglavje 4.4).
English: - If you get any side effects, talk to your doctor, pharmacist or or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: The recommended dose is 284 mg inotersen by subcutaneous injection.
Slovenian: Priporočeni odmerek je 284 mg inotersena; zdravilo se daje v obliki subkutane injekcije.
English: Remove needle cap by pulling it straight off. Do not twist it off.
Slovenian: Odstranite pokrovček igle tako, da ga povlečete naravnost stran.
English: Lift thumb slowly back up
Slovenian: Počasi ponovno dvignite palec nádoba na ostré predmety
English: No dose adjustment is required for patients with mild or moderate hepatic impairment (see section 5.2).
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
English: Sites for injection include the abdomen, upper thigh region, or outer area of the upper arm.
Slovenian: Med primernimi mesti injiciranja so trebuh, zgornji del stegna ali zunanji del nadlakti.
English: PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY TEAR-OFF LID
Slovenian: PODATKI NA PRETISNIH OMOTIH ALI TRAKOVIH POKROV PODSTAVKA, KI SE ODTRGA
English: NAME OF THE MEDICINAL PRODUCT Tegsedi 284 mg solution for injection in pre-filled syringe
Slovenian: IME ZDRAVILA Tegsedi 284 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: ‡ Additional risk factors for bleeding include age >60 years, receiving anticoagulant or antiplatelet medicinal products, and /or prior history of major bleeding events † It is strongly recommended that, unless corticosteroids are contraindicated, the patient receives glucocorticoid therapy to reverse the platelet decline.
Slovenian: ‡ Dodatni dejavniki tveganja za krvavitev vključujejo starost > 60 let, jemanje antikoagulansov ali antitrombotikov in/ali večje krvavitve v anamnezi.
English: Your doctor will check your kidney function before treatment and regularly during treatment with Tegsedi.
Slovenian: Vaš zdravnik bo preveril delovanje vaših ledvic pred zdravljenjem z zdravilom Tegsedi in preverjanje redno ponavljal med zdravljenjem.
English: Push the plunger down
Slovenian: Potisnite bat navzdol
English: The pharmacokinetics of inotersen in patients with hepatic impairment has not been studied.
Slovenian: Pri bolnikih z okvaro jeter niso preučili farmakokinetike inotersena.
English: Stage II Disease p<0.001
Slovenian: stadiju p < 0,001
English: Skin and subcutaneous disorders
Slovenian: Bolezni kože in podkožja pruritus izpuščaj
English: Do not put the needle cap back onto the pre-filled syringe.
Slovenian: Pokrovčka igle ne skušajte ponovno natakniti na napolnjeno injekcijsko brizgo.
English: Early initiation of immunosuppressive therapy should be considered if a diagnosis of glomerulonephritis is confirmed.
Slovenian: Če se potrdi diagnoza glomerulonefritisa, je treba razmisliti o zgodnjem začetku zdravljenja z imunosupresivi.
English: Tegsedi has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Tegsedi nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: The recommended dose of Tegsedi is one dose of 284 mg inotersen.
Slovenian: Priporočeni odmerek zdravila Tegsedi je en 284 mg odmerek inotersena.
English: You should see your doctor immediately if you have unexplained bruising or a rash of small patches of red appearing on the skin (called petechiae), bleeding from skin cuts that does not stop or oozes, bleeding from the gums or nose, blood in urine or stools, bleeding in the whites of your eyes.
Slovenian: Če imate nepojasnjene podplutbe ali drobne rdeče kožne izpuščaje (imenujejo se petehije), ureznine, ki ne prenehajo krvaveti ali se iz njih izloča tekočina, krvavitev iz dlesni ali nosu, kri v urinu ali blatu ali krvavitev v očesno beločnico, morate nemudoma obiskati zdravnika.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija anemija zmanjšano število trombocitov eozinofilija
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.5 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
English: Previous treatment with tafamidis or diflunisal
Slovenian: Da Ne Predhodno zdravljenje s tafamidisom ali diflusinalom1, n (%)
English: How to use Tegsedi
Slovenian: Kako uporabljati zdravilo Tegsedi
English: Baseline n
Slovenian: Izhodišče n
English: Women of child-bearing potential
Slovenian: Vpliv na sposobnost razmnoževanja
English: Insert the needle
Slovenian: Vstavite iglo v kožo
English: V30M TTR mutation1, n (%)
Slovenian: Mutacija TTR V30M
English: Thrombocytopenia
Slovenian: Skupina CMEhoKG
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 284 mg inotersen (as sodium).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena napolnjena injekcijska brizga vsebuje 284 mg inotersena (kot natrijev inotersenat).
English: mean (SD) 1 Based on clinical database
Slovenian: Na podlagi klinične podatkovne zbirke.
English: Put the used pre-filled syringe in a sharps disposal container right away after use.
Slovenian: Po uporabi zavrzite napolnjeno injekcijsko brizgo v vsebnik za ostre predmete.
English: Tattoos and scars should also be avoided.
Slovenian: Odsvetuje se tudi injiciranje na predelih s tetovažami in brazgotinami.
English: Your pre-filled syringe may make a click sound as you push the plunger down.
Slovenian: Ko pritisnete bat navzdol, lahko v napolnjeni injekcijski brizgi zaslišite klik.
English: You should resume the vitamin A supplementation during your second and third trimesters of your pregnancy if your vitamin A levels have not yet returned to normal, because of the increased risk of vitamin A deficiency in the third trimester.
Slovenian: Če se vrednosti vitamina A niso vrnile na normalne ravni, morate v drugem in tretjem trimesečju nosečnosti znova začeti uporabljati dodatek z vitaminom A.
English: Consequently, only effects related to the chemistry of inotersen could be captured in these investigations.
Slovenian: Inotersen pri miših in kuncih ni farmakološko aktiven, zato so v teh raziskavah lahko ugotovili samo učinke, povezane s kemijo inotersena.
English: Tray with tear-off lid.
Slovenian: Podstavek s pokrovom, ki se odtrga.
English: Inotersen showed no effects on fertility, embryo-foetal, or postnatal development in mice and rabbits at approximately 3-fold the maximum recommended human equivalent dose.
Slovenian: Inotersen pri odmerku, ki je ustrezal približno 3-kratnemu največjemu priporočenemu odmerku za ljudi, ni pokazal nobenih učinkov na plodnost, embrio-fetalni ali postnatalni razvoj pri miših in kuncih.
English: The study evaluated 284 mg inotersen administered as one subcutaneous injection once per week, for 65 weeks of treatment.
Slovenian: ki se je v 65-tedenskem obdobju zdravljenja uporabljal v obliki ene subkutane injekcije enkrat tedensko.
English: Inotersen should permanently be discontinued if acute glomerulonephritis is confirmed.
Slovenian: Če se potrdi akutni glomerulonefritis, je treba trajno prenehati zdravljenje z inotersenom.
English: Dublin 2, Ireland
Slovenian: Dublin 2 D02 HW77
English: Inotersen was not evaluated in patients undergoing liver transplantation in clinical trials (section 4.2).
Slovenian: Pri bolnikih po presaditvi jeter inotersena v kliničnih preskušanjih niso preučevali.
English: Other medicines and Tegsedi
Slovenian: Druga zdravila in zdravilo Tegsedi
English: The plunger can feel stiff towards the end of the injection.
Slovenian: Ko je bat že blizu konca brizge, je lahko na občutek bolj tog.