natgillin/translations-raw huggingface dataset:
Statistical significance in favour of inotersen was demonstrated at all thresholds beyond a 0-point change.
Statistična pomembnost v korist inotersena je bila dokazana pri vseh pragovih, ki presegajo spremembo za 0 točk.
Genotoxicity/ carcinogenicity
Genotoksičnost/karcinogenost
Tell your doctor or pharmacist if you are taking, have recently taken or might use any other medicines.
Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
In addition to a prompt to include the contact details of the patient's physician and a call for reporting, the patient card should also:
Poleg poziva, da se vnesejo podatki za stik z bolnikovim zdravnikom, in poziva za poročanje, mora kartica za bolnika:
The first injection administered by the patient or caregiver should be performed under the guidance of an appropriately qualified health care professional.
Prvo injiciranje, ki ga opravi bolnik ali negovalec, mora potekati pod vodstvom ustrezno usposobljenega zdravstvenega delavca.
Let the skin air dry.
Počakajte, da se koža posuši na zraku.
In the event of an overdose, supportive medical care should be provided including consulting with a healthcare professional and close observation of the clinical status of the patient.
V primeru prevelikega odmerjanja je treba zagotoviti podporno medicinsko oskrbo, vključno s posvetovanjem z zdravstvenim delavcem in natančnim spremljanjem kliničnega stanja bolnika.
Every 2 weeks
Vsaka 2 tedna
Patients were randomised 2:1 to receive either inotersen or placebo.
Bolniki so bili randomizirani v razmerju 2 : 1 za prejemanje bodisi inotersena ali placeba.
Children and adolescents Tegsedi should not be used in children and adolescents under 18 years old.
Otroci in mladostniki Zdravila Tegsedi se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
The disease hATTR-PN is classified into 3 stages such that i) Stage 1 patients do not require assistance with ambulation, ii) Stage 2 patients do require assistance with ambulation, and iii) Stage 3 patients are bound to wheelchair.
Bolezen hATTR-PN je razvrščena v tri stadije, pri čemer i) bolniki v 1. stadiju ne potrebujejo pomoči pri gibanju, ii) bolniki v 2. stadiju potrebujejo pomoč pri gibanju in iii) so bolniki v 3. stadiju vezani na invalidski voziček.
Inotersen did not exhibit genotoxic potential in in vitro and in vivo and was not carcinogenic in transgenic rasH2 mice.
Inotersen ni pokazal genotoksičnega potenciala in vitro in vivo ter ni bil kancerogen pri transgenskih miših rasH2.
For consistency of dosing, patients should be instructed to receive the injection on the same day every week.
Za zagotavljanje doslednosti odmerjanja morajo bolniki vsak teden dobiti injekcijo na isti dan.
During the first 60 days of pregnancy, both too high and too low vitamin A levels may be associated with an increased risk of foetal malformation.
V prvih 60 dneh nosečnosti so lahko prevelike in premajhne ravni vitamina A povezane s povečanim tveganjem malformacij ploda.
Dosing should be paused until 3 successive values > 100.
Odmerjanje je treba prekiniti, dokler niso 3 zaporedne vrednosti > 100.
• Remove the plastic tray from the carton and check the expiry date.
• Vzemite plastični podstavek iz škatle in preverite rok uporabnosti.
In addition, the corresponding frequency category for each ADR is based on 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).
Ustrezna kategorija pogostnosti za vsak neželeni učinek temelji na naslednjem dogovoru: zelo pogosti (≥ 1/10); pogosti (od ≥ 1/100 do < 1/10); občasni (od ≥ 1/1.000 do < 1/100); redki (od ≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000).
UPCR and eGFR should be monitored every 3 months or more frequently, as clinically indicated, based on history of chronic kidney disease and/or renal amyloidosis.
UPCR in eGFR je treba spremljati na vsake 3 mesece ali pogosteje, kot je klinično indicirano glede na zgodovino kronične bolezni ledvic in/ali ledvične amiloidoze.
The most frequently observed adverse reactions during treatment with inotersen were events associated with injection site reactions (50.9%).
Najpogosteje opaženi neželeni učinki med zdravljenjem z inotersenom so bili dogodki, povezani z reakcijami na mestu injiciranja (50,9 %).
In the placebo group, mean serum TTR concentration decreased by 8.50% at Week 3 and then remained fairly constant throughout the treatment period.
V skupini, ki je prejemala placebo, se je povprečna koncentracija TTR v serumu v 3. tednu znižala za 8,50 % in nato ostala dokaj konstantna skozi celotno obdobje zdravljenja.
Pharmacotherapeutic group: Other Nervous System Drugs, ATC code: N07XX15
Farmakoterapevtska skupina: Druga zdravila z delovanjem na živčevje, oznaka ATC: N07XX15
Baseline demographic and disease characteristics are shown in Table 3.
Demografske značilnosti in značilnosti bolezni ob izhodišču so prikazane v preglednici 3.
Hold the pre-filled syringe in 1 hand.
Napolnjeno injekcijsko brizgo držite v eni roki.
Before using your pre-filled syringe, your doctor should show you or your caregiver how to use it the right way.
Preden uporabite napolnjeno injekcijsko brizgo, mora zdravnik vam ali vašemu negovalcu pokazati, kako se brizgo pravilno uporablja.
What you need to know before you use Tegsedi 3.
Kaj morate vedeti, preden boste uporabili zdravilo Tegsedi 3.
If not used within 6 weeks, it should be discarded.
Če se ne uporabi v 6 tednih, ga je treba zavreči.
See Section 4.8 for how to report adverse reactions
Glejte poglavje 4.8, kako poročati o neželenih učinkih.
Subjects that terminate the treatment early irrespective of the reason or have missing week 66 data are considered as non-responders.
Bolniki, ki so prezgodaj prekinil zdravljenje ne glede na vzrok, ali bolniki, za katere ni podatkov za 66. teden, se štejejo kot bolniki, ki se niso odzvali.
UPCR and eGFR should be monitored for 8 weeks following discontinuation of treatment.
UPCR in eGFR je treba spremljati še 8 tednov po prekinitvi zdravljenja.
Due to the long half-life of inotersen (see section 5.2), a vitamin A deficit may even develop after cessation of treatment.
Zaradi dolgega razpolovnega časa izločanja inotersena (glejte poglavje 5.2), se pomanjkanje vitamina A lahko pojavi tudi po prekinitvi zdravljenja.
Due to the potential teratogenic risk arising from unbalanced vitamin A levels, inotersen should not be used during pregnancy, unless the clinical condition of the woman requires treatment with inotersen.
Zaradi morebitnega teratogenega tveganja, ki je posledica neuravnovešenih ravni vitamina A, se inotersena med nosečnostjo ne sme uporabljati, razen če je zaradi kliničnega stanja ženske potrebno zdravljenje z inotersenom.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
You will only be treated with Tegsedi if these are all at acceptable levels and your doctor will repeat these checks regularly during treatment.
Z zdravilom Tegsedi se boste zdravili samo, če je vse našteto na sprejemljivi ravni, in vaš zdravnik bo med zdravljenjem redno ponavljal te preiskave.
Lift here and pull to open
Tukaj dvignite in s potegom odprite
TTR is a carrier protein for retinol binding protein 4 (RBP4) which is the principal carrier of vitamin A (retinol).
TTR je prenašalna beljakovina za beljakovino 4, ki veže retinol (RBP4), ki je glavni prenašalec vitamina A (retinola).
Yes No hATTR-CM2, n (%) hATTR-PN Disease Duration3 (months)
Da Ne hATTR-CM2, n (%) Trajanje bolezni hATTR-PN3 (meseci)
Lift the whole pre-filled syringe straight up.
Celotno napolnjeno injekcijsko brizgo dvignite naravnost navzgor.
6.6 Special precautions for disposal and other handling Tegsedi should be inspected visually prior to administration.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravilo Tegsedi je treba pred uporabo vizualno pregledati.
This suggests an immunologically related mechanism.
To kaže mehanizem z imunološko povezavo.
• Alert HCPs that the patient is taking Tegsedi, its indication and the key safety concerns;
• opozoriti zdravstvene delavce, da bolnik jemlje zdravilo Tegsedi, vsebovati njegove indikacije in ključne skrbi glede varnosti;
Hold the plunger fully down and wait for 5 seconds.
Držite ga pritisnjenega do konca navzdol in počakajte 5 sekund.
• dry eyes, poor vision, decrease in night vision, hazy or cloudy vision
• suhe oči, slab vid, poslabšanje nočnega vida, meglen oz. nejasen vid.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Akcea Therapeutics Ireland Ltd
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Akcea Therapeutics Ireland Ltd
When you do not have enough platelets, like in thrombocytopenia, your blood may not clot quickly enough to stop bleeding.
Če nimate dovolj trombocitov (kot je značilno za trombocitopenijo), se vaša kri morda ne bo strjevala dovolj hitro, da bi ustavila krvavitve.
If you or your caregiver have any questions, ask your doctor.
Če imate vi ali vaš negovalec dodatna vprašanja, se posvetujte z zdravnikom.
Therefore, reduction in plasma TTR is expected to result in reduction of plasma retinol levels to below the lower limit of normal.
Zato se pričakuje, da bo znižanje ravni TTR v plazmi znižalo ravni retinola v plazmi pod spodnjo normalno mejo.
In the case of UPCR ≥ 2 g/g (226 mg/mmol), which is confirmed on repeat testing, dosing of inotersen should be paused while further evaluation for acute glomerulonephritis is performed.
Če je UPCR ≥ 2 g/g (226 mg/mmol) in se vrednost potrdi s ponovnim testiranjem, je treba odmerjanje inotersena prekiniti, medtem ko se opravlja nadaljnja ocena glede akutnega glomerulonefritisa.
Do not inject into tattoos, scars or damaged skin.
Ne injicirajte v tetovaže, brazgotine ali poškodovano kožo.
Look in the inspection area to check that the solution is clear and colourless or pale yellow.
V območju za preverjanje vsebine preverite, ali je raztopina bistra in brezbarvna ali bledo rumena.
Slowly insert the needle into the chosen injection site at a 90° angle until it is fully inserted.
Iglo počasi zabodite na izbrano mesto injiciranja pod kotom 90°, dokler ni vstavljena v celoti.
Patients with UPCR more than or equal to twice the upper limit of normal, or eGFR < 60 ml/min, which is confirmed on repeat testing and in the absence of an alternative explanation, should be monitored every 4 weeks.
Bolnike z vrednostjo UPCR, ki ustreza najmanj dvakratni zgornji normalni vrednosti, ali z vrednostjo eGFR < 60 ml/min, ki se potrdi s ponovnim testiranjem ali če ni drugačnega pojasnila, je treba spremljati na vsake 4 tedne.
Prior to the launch of Tegsedi in each Member State (MS), the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Pred prihodom zdravila Tegsedi na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnih gradiv, vključno z mediji za komunikacijo, načini distribucije in vsemi drugimi vidiki programa.
After use, the safety spring is automatically activated and retracts the needle.
Po uporabi se varnostna vzmet samodejno aktivira in potisne iglo navznoter.
Your doctor may refer you to an eye specialist for a check-up if it is necessary.
Zdravnik vas bo po potrebi napotil na pregled pri specialistu za oči.
Tegsedi is used when the disease is causing symptoms of polyneuropathy (nerve damage).
Zdravilo Tegsedi se uporablja, kadar bolezen povzroča simptome polinevropatije (poškodbe živcev).
It is unknown if vitamin A supplementation can compensate for the risk of vitamin A deficiency that might affect your unborn child (see “Warnings and precautions” above).
Ni znano, ali uporaba dodatkov vitamina A lahko zmanjša tveganje za pomanjkanje vitamina A, ki lahko prizadene vašega nerojenega otroka (glejte poglavje »Opozorila in previdnostni ukrepi« zgoraj).
If the plunger does not rise up automatically when you release the pressure, it means the safety spring did not activate and you should push the plunger again but harder.
Če se bat ne dvigne sam od sebe, ko ga nehate pritiskati, to pomeni, da se varnostna vzmet ni aktivirala; ponovno pritisnite bat, vendar tokrat močneje.
Tegsedi is for injection under the skin (subcutaneous use) only.
Zdravilo Tegsedi je namenjeno samo za injiciranje pod kožo (subkutana uporaba).
Previous use of stabilisers p<0.001
Predhodna uporaba stabilizatorjev p < 0,001
You may need to press a little harder on the plunger to make sure you have pushed it as far as it will go.
Takrat morate uporabiti nekoliko močnejši pritisk, da ga zagotovo pritisnete do konca.
Do not use this medicine after the expiry date, which is stated on the carton, tray and on the pre-filled syringe after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, podstavku in napolnjeni brizgi poleg oznake »EXP«.
Always hold by the body of the syringe.
Vedno držite telo brizge.
Following subcutaneous administration, elimination half-life for inotersen is approximately 1 month.
Po subkutani uporabi je razpolovni čas izločanja inotersena približno 1 mesec.
mean (SD) hATTR-CM Disease Duration
Srednja vrednost (SD) Trajanje bolezni hATTR-CM
Other most commonly reported adverse reactions with inotersen were nausea (31.3%), anaemia (27.7%), headache (23.2%), pyrexia (19.6%), peripheral oedema (18.8%), chills (17.9%), vomiting (15.2%), thrombocytopenia (13.4%) and platelet count decreased (10.7%).
Drugi najpogostejši neželeni učinki, ki so se pojavili pri uporabi inotersena, so bili navzea (31,3 %), anemija (27.7 %), glavobol (23,2 %), pireksija (19,6 %), periferni edem (18,8 %), mrazenje (17,9 %), bruhanje (15,2 %), trombocitopenija (13,4 %) in zmanjšano število trombocitov (10,7 %).
The European Medicines Agency has waived the obligation to submit the results of studies with Tegsedi in all subsets of the paediatric population in transthyretin amyloidosis (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Tegsedi za vse podskupine pediatrične populacije s transtiretinsko amiloidozo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
All subsequent doses should be injected once weekly on the same day each week.
Vse nadaljnje odmerke je treba injicirati enkrat tedensko, vsak teden na isti dan.
Inotersen is highly bound to human plasma protein (> 94%) and the fraction bound is independent of drug concentration.
Inotersen se močno veže na beljakovine v človeški plazmi (> 94 %) in vezani delež je neodvisen od koncentracije zdravila.
Each pre-filled syringe contains one dose and is for one-time use only.
Vsaka napolnjena injekcijska brizga vsebuje en odmerek in je samo za enkratno uporabo.
A responder analysis of mNIS+7 using thresholds ranging from a 0- to 30-point increase from baseline (using the safety set), showed the inotersen group had approximately a 2-fold higher response rate than the placebo group at each threshold tested, demonstrating consistency of response.
Analiza odziva mNIS+7 z uporabo mejnih vrednosti povečanja glede na izhodiščno vrednost, ki se gibljejo med 0 in 30 točkami (uporaba skupine bolnikov za analizo varnosti), je pokazala, da je imela skupina z inotersenom približno dvakrat višjo stopnjo odziva kot skupina s placebom pri vsakem testiranem pragu, kar kaže doslednost odziva.
Hold the plunger fully down and wait 5 seconds
Držite bat pritisnjen do konca navzdol in počakajte 5 sekund
Also contains: hydrochloric acid, sodium hydroxide, water for injections.
Vsebuje tudi: klorovodikovo kislino, natrijev hidroksid, vodo za injekcije.
Defined as all patients with a diagnosis of hereditary transthyretin amyloidosis with cardiomyopathy (hATTR-CM) at study entry or left ventricular wall thickness >1.3 cm on echocardiogram without a known history of persistent hypertension Duration from symptom onset to informed consent date
Opredeljeno kot vsi bolniki z diagnozo dedne transtiretinske amiloidoze s kardiomiopatijo (hATTR-CM) ob vstopu v študijo ali z debelino stene levega prekata > 1,3 cm na ehokardiogramu brez znane zgodovine persistentne hipertenzije.
For single use only
Samo za enkratno uporabo
The solution should be clear and colourless to pale yellow.
Raztopina mora biti bistra in brezbarvna do bledo rumena.
It is not known whether vitamin A supplementation in pregnancy will be sufficient to prevent vitamin A deficiency if the pregnant female continues to receive inotersen.
Ni znano, ali bo dodajanje vitamina A v nosečnosti zadostovalo za preprečevanje pomanjkanja vitamina A, če nosečnica nadaljuje zdravljenje z inotersenom.
- 1 Pre-filled syringe from the refrigerator - 1 Alcohol wipe (not supplied) - 1 Gauze pad or cotton ball (not supplied) - 1 Puncture-resistant (sharps) container (not supplied)
- 1 napolnjena injekcijska brizga iz hladilnika - 1 alkoholni robček (ni priložen) - 1 blazinica iz gaze ali vate (ni priložena) - 1 posoda, odporna proti vbodom (ni priložena)
Tegsedi should not be injected into areas of skin disease or injury.
Zdravila Tegsedi se ne sme injicirati na predelih s kožnimi boleznimi ali poškodbami.
Tegsedi will reduce the level of vitamin A in your body, which is important for normal foetal development during pregnancy.
Zdravilo Tegsedi bo v vašem telesu zmanjšalo raven vitamina A, ki je pomemben za normalen razvoj ploda med nosečnostjo.
Inotersen is a 2′-O-2-methoxyethyl (2′-MOE) phosphorothioate antisense oligonucleotide (ASO) inhibitor of human transthyretin (TTR) production.
Inotersen je 2′-O-2-metoksietilni (2‘-MOE) fosforotioatni protismerni oligonukleotidni (ASO) zaviralec proizvodnje humanega transtiretina (TTR).
Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Znotraj vsake skupine pogostnosti so neželeni učinki zdravila navedeni po padajoči resnosti.
Following distribution to the patient, can be stored 6 weeks below 30°C.
Ko se zdravilo preda bolniku, se lahko shrani za 6 tednov pod 30 °C.
Subgroup Analysis of mNIS+7 and Norfolk QoL-DN mNIS+7
Analiza podskupin mNIS+7 in Norfolk QoL-DN mNIS+7
Results across multiple disease characteristics [TTR mutation (V30M, non-V30M)], disease stage (Stage 1, Stage 2), previous treatment with tafamidis or diflunisal (yes, no), presence of hATTR-CM (yes, no) at Week 66 showed statistically significant benefit in all subgroups based on mNIS+7 composite score and all but one of these subgroups (CM-Echo Set; p=0.067) based on Norfolk QoL-DN total score (Table 5).
Rezultati v zvezi z več značilnostmi bolezni [mutacija TTR (V30M, ne-V30M)], stadij bolezni (1. stadij, 2. stadij), predhodno zdravljenje s tafamidisom ali diflunisalom (da, ne), prisotnost hATTR-CM (da, ne) v 66. tednu so pokazali statistično značilno korist v vseh podskupinah na podlagi sestavljenega rezultata mNIS+7 in v vseh podskupinah razen ene (skupina CM-EhoKG, p = 0,067) na podlagi skupnega rezultata na vprašalniku Norfolk QoL-DN (preglednica 5).
Platelet count < 100 x 10
Število trombocitov < 100 x 10
• The list of signs and symptoms of thrombocytopenia, glomerulonephritis, and ocular toxicity due to vitamin A deficiency, highlighting that these might be severe or life-threatening, and advising patients to call immediately their doctor or attend the emergency room if such signs and symptoms appear;
• na seznam znakov in simptomov trombocitopenije, glomerulonefritisa in očesne toksičnosti zaradi pomanjkanja vitamina A, poudariti, da so ti znaki in simptomi lahko hudi ali smrtno nevarni, ter bolnikom svetovati, naj takoj pokličejo zdravnika ali obiščejo ambulanto za nujno medicinsko pomoč, če se pojavijo ti znaki in simptomi;
Symptoms of glomerulonephritis are foaming urine, pink or brown coloured urine, blood in the urine, and passing less urine than usual.
Simptomi glomerulonefritisa so penjenje urina, rožnato ali rjavo obarvan urin, kri v urinu in manjša količina urina kot običajno.
In the case of a decrease in eGFR >30%, in the absence of an alternative explanation, pausing of inotersen dosing should be considered pending further evaluation of the cause.
Če se eGFR zniža za > 30 % in za to ni mogoče najti drugačnega pojasnila, je treba razmisliti o prekinitvi odmerjanja inotersena, dokler se vzroka nadalje ne razišče.
Do not remove needle cap until you have reached Step 6 of these instructions and are ready to inject Tegsedi;
Ne odstranite pokrovčka igle, dokler ne dosežete 6. koraka teh navodil in ste pripravljeni injicirati zdravilo Tegsedi.
Following subcutaneous administration, inotersen is absorbed rapidly into systemic circulation in a dose-dependent fashion with the median time to maximum plasma concentrations (Cmax) of inotersen typically reached within 2 to 4 hours.
Po subkutani aplikaciji se inotersen hitro absorbira v sistemski obtok v odvisnosti od odmerka, pri čemer je srednji čas do najvišje koncentracije inotersena v plazmi (Cmax) navadno od 2 do 4 ure.
On reinitiation of treatment dose frequency should be reduced to 284 mg every 2 weeks.
Ob ponovni uvedbi zdravljenja je treba pogostnost odmerjanja zmanjšati na 284 mg vsaka 2 tedna.
Hold the skin around at the injection site as your healthcare provider has instructed you.
Držite kožo na mestu injiciranja, kot vas je poučil zdravstveni delavec.
Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first.
Pri vsakem organskem sistemu so neželeni učinki razvrščeni po pogostnosti, pri čemer so najpogostejši učinki navedeni najprej.
Patients undergoing liver transplant
Bolniki s presajenimi jetri
Daily until 2 successive values above 25.
Dnevno, dokler nista 2 zaporedni vrednosti nad 25.
It is important to push the plunger all the way down.
Pomembno je, da pritisnete bat do konca navzdol.
Dosing frequency should be reduced to 284 mg every 2 weeks
Pogostnost odmerjanja je treba zmanjšati na 284 mg vsaka 2 tedna.
The apparent volume of distribution of inotersen at steady-state is 293 L in patients with hATTR.
Navidezni volumen porazdelitve inotersena v stanju dinamičnega ravnovesja je 293 litrov pri bolnikih s hATTR.
Twice weekly until 3 successive values above 75 then weekly monitoring.
Dvakrat tedensko, dokler niso 3 zaporedne vrednosti nad 75, nato tedensko spremljanje.
It works by reducing production of transthyretin by the liver and so lowers the risk of fibres of transthyretin being deposited in body organs and causing symptoms.
Deluje z zaviranjem proizvodnje transtiretina v jetrih ter tako zmanjša tveganje, da bi se vlakna transtiretina nalagala v telesnih organih in povzročala simptome.
P-value
Vrednost P
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1296/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/18/1296/001 EU/1/18/1296/002
Patients were stratified for stage of disease (Stage 1 versus Stage 2), TTR mutation (V30M versus non-V30M) and previous treatment with either tafamidis or diflunisal (yes versus no).
Bolniki so bili stratificirani glede na stadij bolezni (1. stadij ali 2. stadij), mutacijo TTR (V30M ali ne-V30M) in predhodno zdravljenje s tafamidisom ali diflunisalom (da ali ne).
It is unknown if continuation of your vitamin A supplementation with 3000 IU per day will be harmful to your unborn child in the first trimester of your pregnancy, but this dose should not be exceeded.
Ni znano, ali nadaljevanje z uporabo dodatka vitamina A v dnevni količini 3.000 i.e. škoduje nerojenemu otroku v prvem trimesečju nosečnosti, vendar tega odmerka ne smete preseči.
Recommendations for adjustments to monitoring frequency and inotersen dosing are specified in Table 1 (see section 4.2).
Priporočila za prilagajanje pogostosti spremljanja in odmerjanja inotersena so v preglednici 1 (glejte poglavje 4.2).