natgillin/translations-raw huggingface dataset:
Votubia may be reinitiated at a daily dose approximately 50% lower than the dose previously administered depending on the individual clinical circumstances.
Zdravilo Votubia je glede na klinično stanje posameznika mogoče ponovno uvesti v dnevnem odmerku, ki je za približno 50 % nižji od odmerka pred prekinitvijo.
If the patient does not drink it within 30 minutes if an oral syringe has been used or within 60 minutes if a small glass has been used, throw it away and prepare a new suspension.
Če bolnik suspenzije ne zaužije v 30 minutah po pripravi, kadar uporablja brizgo za peroralno dajanje, ali v 60 minutah po pripravi, kadar uporablja majhen kozarec, jo je treba zavreči in pripraviti novo suspenzijo.
Votubia 2 mg dispersible tablets are available in packs containing 10 x 1, 30 x 1 or 100 x 1 dispersible tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Zdravilo Votubia 2 mg disperzibilne tablete je na voljo v pakiranjih, ki vsebujejo 10 x 1, 30 x 1 ali 100 x 1 disperzibilno tableto v perforiranih enoodmernih pretisnih omotih po 10 x 1 tableto.
Votubia 3 mg dispersible tablets are white to slightly yellowish, round, flat tablets with a bevelled edge and no score.
Votubia 3 mg disperzibilne tablete so okrogle ploščate tablete, bele do nekoliko rumenkaste barve, z zaobljenim robom in brez razdelilne zareze.
There are currently not sufficient data to allow dosing recommendations in this situation.
Zaenkrat ni dovolj podatkov, da bi lahko oblikovali priporočila za odmerjanje v takem primeru, zato sočasna uporaba zdravila Votubia in močnih zaviralcev ni priporočena.
Votubia 5 mg tablets are available in packs containing 30 x 1 or 100 x 1 tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Zdravilo Votubia 5 mg tablete je na voljo v pakiranjih, ki vsebujejo 30 x 1 ali 100 x 1 tableto v perforiranih enoodmernih pretisnih omotih po 10 x 1 tableto.
Cmax is dose-proportional between 5 and 10 mg. Everolimus is a substrate and moderate inhibitor of PgP.
Everolimus je substrat in zmeren zaviralec P-glikoproteina.
Votubia 5 mg dispersible tablets
Votubia 5 mg disperzibilne tablete
Respiratory, thoracic and mediastinal disorders Very common Cough
Bolezni dihal, prsnega koša in mediastinalnega prostora zelo pogosti kašelj pogosti krvavitev iz nosu, pljučnica
Votubia 10 mg tablets are available in packs containing 10 x 1, 30 x 1 or 100 x 1 tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Zdravilo Votubia 10 mg tablete je na voljo v pakiranjih, ki vsebujejo 10 x 1, 30 x 1 ali 100 x 1 tableto v perforiranih enoodmernih pretisnih omotih po 10 x 1 tableto.
SEGA patients receiving concomitant potent CYP3A4 inducers may require an increased Votubia dose to achieve
Za bolnike s SEGA v povezavi s TSC: Pri bolnikih, ki sočasno prejemajo močne induktorje CYP3A4, so lahko potrebni višji odmerki zdravila Votubia za enako izpostavljenost zdravilu kot pri bolnikih, ki ne prejemajo močnih induktorjev.
They are engraved with “D3” on one side and “NVR” on the other.
Na eni strani imajo vtisnjeno oznako “D3”, na drugi pa “NVR”.
Insomnia, aggression, irritability Nervous system disorders Very common Headache Uncommon Dysgeusia Vascular disorders Very common Hypertension Common
Bolezni živčevja zelo pogosti glavobol občasni motnje okušanja
Votubia 2.5 mg tablets are available in packs containing 10 x 1, 30 x 1 or 100 x 1 tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Zdravilo Votubia 2,5 mg tablete je na voljo v pakiranjih, ki vsebujejo 10 x 1, 30 x 1 ali 100 x 1 tableto v perforiranih enoodmernih pretisnih omotih po 10 x 1 tableto.
White to slightly yellow, elongated tablets of approximately 15.1 x 6.0 mm, with a bevelled edge and no score, engraved with “UHE” on one side and “NVR” on the other.
Podolgovate tablete, velikosti približno 15,1 x 6,0 mm, bele do nekoliko rumenkaste barve, z zaobljenim robom in brez razdelilne zareze, z vtisnjenima oznakama “UHE” na eni strani in “NVR” na drugi.
Renal failure events
Primeri ledvične odpovedi
White to slightly yellow, elongated tablets of approximately 12.1 x 4.9 mm, with a bevelled edge and no score, engraved with “5” on one side and “NVR” on the other.
Podolgovate tablete, velikosti približno 12,1 x 4,9 mm, bele do nekoliko rumenkaste barve, z zaobljenim robom in brez razdelilne zareze, z vtisnjenima oznakama “5” na eni strani in “NVR” na drugi.
They are engraved with “D1” on one side and “NVR” on the other.
Na eni strani imajo vtisnjeno oznako “D1”, na drugi pa “NVR”.
They are engraved with “D2” on one side and “NVR” on the other.
Na eni strani imajo vtisnjeno oznako “D2”, na drugi pa “NVR”.
Impaired wound healing is a class effect of rapamycin derivatives, including Votubia.
Slabo celjenje ran je značilnost celotne skupine derivatov rapamicina, vključno z zdravilom Votubia, zato je potrebna previdnost pri uporabi zdravila Votubia v obdobju po operaciji.
Open the blister just before taking Votubia dispersible tablets.
Disperzibilne tablete Votubia vzemite iz pretisnega omota tik pred uporabo.
While taking Votubia, be vigilant for symptoms and signs of infection; if a diagnosis of infection is made, institute appropriate treatment promptly and consider interruption or discontinuation of Votubia.
Če ugotovijo okužbo, morajo takoj začeti z ustreznim zdravljenjem in razmisliti o prekinitvi zdravljenja z zdravilom Votubia.
Baseline n=28
Votubia n=79
Stomatitis, including mouth ulcerations and oral mucositis, is the most commonly reported adverse reaction in patients treated with Votubia (see section 4.8).
Pri bolnikih, ki jemljejo zdravilo Votubia, je najpogosteje poročan neželeni učinek stomatitis, ki vključuje razjede v ustni votlini in vnetje ustne sluznice (glejte poglavje 4.8).
Open the blister just before taking the Votubia tablets.
Tablete Votubia vzemite iz pretisnega omota tik pred uporabo.
Votubia 5 mg dispersible tablets everolimus
Votubia 5 mg disperzibilne tablete everolimus
Reduction from baseline in seizure frequency (%)
brez napadov ni podatka zmanjšanje pogostnosti napadov od izhodiščne vrednosti (%)
General disorders and administration site conditions Very common Pyrexia, fatigue Investigations
Splošne težave in spremembe na mestu aplikacije zelo pogosti zvišana telesna temperatura, utrujenost
White to slightly yellowish, round, flat tablets of approximately 12.1 mm in diameter, with a bevelled edge and no score, engraved with “D5” on one side and “NVR” on the other.
Okrogle ploščate tablete, premera približno 12,1 mm, bele do nekoliko rumenkaste barve, z zaobljenim robom in brez razdelilne zareze, z vtisnjenima oznakama “D5” na eni strani in “NVR” na drugi.
Uncommon side effects (may affect up to 1 in 100 people) Muscle spasms, fever, red-brown urine which may be symptoms of a muscle disorder (rhabdomyolysis)
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) mišični krči, zvišana telesna temperatura, rdeče rjavo obarvan urin, kar so lahko simptomi motenj v delovanju mišic (rabdomioliza) kašelj z izmečkom, bolečine v prsnem košu, zvišana telesna temperatura (znaki vnetja dihalnih poti, ki ga imenujemo virusni bronhitis) motnje v zaznavanju okusa (disgevzija) motnje menstruacije, kot npr. zapoznele menstruacije zvišana raven ženskega reproduktivnega hormona (zvišana vrednost folikle stimulirajočega hormona v krvi)
White to slightly yellowish, round, flat tablets of approximately 7.1 mm in diameter, with a bevelled edge and no score, engraved with “D1” on one side and “NVR” on the other.
Okrogle ploščate tablete, premera približno 7,1 mm, bele do nekoliko rumenkaste barve, z zaobljenim robom in brez razdelilne zareze, z vtisnjenima oznakama “D1” na eni strani in “NVR” na drugi.
White to slightly yellowish, round, flat tablets of approximately 9.1 mm in diameter, with a bevelled edge and no score, engraved with “D2” on one side and “NVR” on the other.
Okrogle ploščate tablete, premera približno 9,1 mm, bele do nekoliko rumenkaste barve, z zaobljenim robom in brez razdelilne zareze, z vtisnjenima oznakama “D2” na eni strani in “NVR” na drugi.
White to slightly yellowish, round, flat tablets of approximately 10.1 mm in diameter, with a bevelled edge and no score, engraved with “D3” on one side and “NVR” on the other.
Okrogle ploščate tablete, premera približno 10,1 mm, bele do nekoliko rumenkaste barve, z zaobljenim robom in brez razdelilne zareze, z vtisnjenima oznakama “D3” na eni strani in “NVR” na drugi.
Independent central review
Po presoji neodvisnega centralnega pregledovalca radioloških izvidov.
The following may increase the risk of side effects with Votubia: ketoconazole, itraconazole, voriconazole, or fluconazole and other antifungals used to treat fungal infections.
Naslednja zdravila lahko povečajo tveganje za neželene učinke ob uporabi zdravila Votubia: ketokonazol, itrakonazol, vorikonazol, flukonazol ali druga protiglivična zdravila, ki jih uporabljamo za zdravljenje glivičnih okužb, klaritromicin, telitromicin ali eritromicin, antibiotiki za zdravljenje bakterijskih okužb, ritonavir in druga zdravila, ki se uporabljajo za zdravljenje okužbe s HIV/AIDSa, verapamil ali diltiazem za zdravljenje bolezni srca ali visokega krvnega tlaka, dronedaron, zdravilo, ki pomaga uravnavati srčni utrip, ciklosporin, zdravilo za preprečevanje zavrnitve presadka, imatinib za zaviranje razmnoževanja nenormalnih celic.
The syringe should be gently inverted 5 times immediately prior to administration.
Tik pred zaužitjem je treba brizgo petkrat nežno obrniti navzgor in navzdol.
Metabolism and nutrition disorders Very common Decreased appetite, hypercholesterolaemia Common
Žilne bolezni pogosti hipertenzija, limfedem
Exacerbation
Napredovanje
Place them into the barrel of the oral syringe straight away.
Disperzibilne tablete vzemite iz pretisnega omota in jih takoj položite v telo brizge za peroralno dajanje.
• 2 clean glasses • Approximately 30 ml of water
• približno 30 ml vode bat telo brizge merilne oznake vrh
Infections and infestations Very common Nasopharyngitis, upper respiratory tract infection, pneumonia a, urinary tract infection, sinusitis, pharyngitis
Presnovne in prehranske motnje zelo pogosti zmanjšan apetit, hiperholesterolemija pogosti hipertrigliceridemija, hiperlipidemija, hipofosfatemija, hiperglikemija Psihiatrične motnje pogosti insomnija, agresivnost, razdražljivost
Includes (very common) stomatitis, mouth ulceration, aphthous ulcer; (common) tongue ulceration, lip ulceration and (uncommon) gingival pain, glossitis c
Vključuje stomatitis, razjede v ustih in aftozne razjede (zelo pogosti), razjede na jeziku in razjede na ustnicah (pogosti) ter boleče dlesni in vnetje jezika (občasni).
These signs are listed at the beginning of section 4.
Ti znaki so navedeni na začetku poglavja 4.
• This can help to reduce the effects of this illness.
• To pomaga zmanjšati učinke bolezni.
This causes the symptoms of the illness.
To povzroča simptome bolezni.
From a microbiological point of view, it is recommended that the product should be used immediately.
Z mikrobiološkega stališča se priporoča takojšnja uporaba zdravila.
• Amyloid can build up around the nerves, heart, and other places in the body, preventing them from working normally.
• Amiloid se lahko nalaga okoli živcev, srca in drugih mest v telesu ter preprečuje njihovo normalno delovanje.
Your doctor may refer you to an eye specialist for a check-up if it is necessary.
Zdravnik vas bo morda napotil na pregled k specialistu za oči, če bo to potrebno.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 August 2018
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 27. avgust 2018
Your doctor will tell you whether your condition allows you to drive vehicles and use machines safely.
Vaš zdravnik vam bo povedal, ali vam vaše stanje dovoljuje varno upravljanje vozil in strojev.
The frequency of the adverse reactions is expressed according to the following categories:
Pogostnost neželenih učinkov je izražena z naslednjimi kategorijami:
Symptoms of vitamin A deficiency may include:
Simptomi pomanjkanja vitamina A lahko vključujejo:
• Low or high blood pressure
• nizek ali visok krvni tlak
• Efavirenz, a medicine used to treat HIV infection and AIDS
• efavirenz, ki se uporablja za zdravljenje okužbe z virusom HIV in aidsa
• The active substance is patisiran.
• Učinkovina je patisiran.
Gender and race
Spol in rasa
Greater than 95% of patisiran in the circulation is associated with lipid nanoparticles.
Več kot 95 % patisirana v obtoku je povezanega z lipidnimi nanodelci.
No formal clinical drug interaction studies have been performed.
Formalnih kliničnih študij medsebojnega delovanja zdravil niso izvedli.
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1320/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1320/001
• if you have ever had a severe allergic reaction to patisiran, or any of the other ingredients of this medicine (listed in section 6).
• če ste kadar koli imeli resno alergijsko reakcijo na patisiran ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Secondary Norfolk QoL-DNb
Sekundarni Norfolk QoL-DNb
Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake »EXP«.
Children and adolescents Onpattro is not recommended in children and adolescents under 18 years of age.
Otroci in mladostniki Zdravilo Onpattro se ne priporoča pri otrocih in mladostnikih, starih manj kot 18 let.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Onpattro N=148
Zdravilo Onpattro n = 148
Table 2: Clinical Efficacy Results from the Placebo-Controlled Study
Preglednica 2: Rezultati klinične učinkovitosti iz študij, nadzorovanih s placebom
• Very common (≥ 1/10)
• zelo pogosti (≥ 1/10)
All events were mild or moderate in severity and did not lead to treatment discontinuation.
Vsi učinki so bili blagi ali zmerni in niso vodili v prekinitev zdravljenja.
• It is given as a drip into a vein (‘intravenous infusion') usually over about 80 minutes.
• Daje se s kapanjem v veno (»intravensko infundiranje«), ki običajno traja približno 80 minut.
The educational material for patients (a home infusion guide detailing the steps to undertake during home infusion) should include information about:
Izobraževalno gradivo za bolnike (vodnik za prejemanje infuzij na domu, v katerem so navedeni vsi koraki, ki jih je treba izvesti med prejemanjem infuzije na domu) mora vsebovati informacije o:
• Requirements for home infusion, including availability and timely administration of the appropriate premedication;
• zahtevah za dajanje infuzij na domu, vključno z razpoložljivostjo in pravočasno uporabo ustreznih zdravil za premedikacijo;
Improvement was observed at 9 months, the first post-baseline assessment in the study.
Izboljšanje so opazili tudi v 9. mesecu, ob prvi oceni v študiji po izhodišču.
Infusion-related reactions Infusion-related reactions are very common (may affect more than 1 in 10 people).
Reakcije, povezane z infuzijo Reakcije, povezane z infuzijo, so zelo pogoste (pojavijo se lahko pri več kot 1 od 10 bolnikov).
Women of child-bearing age
Ženske v rodni dobi
Onpattro is used in adults only.
Zdravilo Onpattro se uporablja samo pri odraslih.
Benefits relative to placebo were also observed across all mNIS+7 components.
Koristi v primerjavi s placebom so opazili tudi v vseh komponentah mNIS+7.
One additional patient had pre-existing anti-drug antibodies.
En dodaten bolnik je imel že obstoječa protitelesa proti zdravilu.
Chemical and physical in-use stability has been demonstrated for 16 hours at room temperature (up to 30°C).
Kemična in fizikalna stabilnost med uporabo sta bili dokazani za 16 ur pri sobni temperaturi (do 30 °C).
Approximately 10% of patients had the V30M mutation and early onset of symptoms (< 50 years of age).
Približno 10 % bolnikov je imelo mutacijo V30M in zgodnji nastop simptomov (starost < 50 let).
INFORMATION IN BRAILLE Onpattro
PODATKI V BRAILLOVI PISAVI Onpattro
For patients weighing ≥ 100 kg, the maximum recommended dose is 30 mg.
Za bolnike, ki tehtajo ≥ 100 kg, je največji priporočeni odmerek 30 mg.
• Bupropion, a medicine used to treat depression or to help you to stop smoking
• bupropion, ki se uporablja za zdravljenje depresije in kot pomoč pri odvajanju od kajenja
Patisiran is metabolized by nucleases to nucleotides of various lengths.
Patisiran se z nukleazami presnavlja v nukleotide različnih dolžin.
• Suitability of the patient for home infusion;
• primernosti bolnika za prejemanje infuzij na domu;
• Remove Onpattro from the refrigerator.
• Zdravilo Onpattro vzemite iz hladilnika.
In general, all findings observed at the end of dosing in the rat and monkey toxicity studies had either a full recovery or were observed with reduced severity at the end of the 60-90 day recovery period, indicating at least partial reversibility.
Na splošno so vsi izsledki, ki so jih ob koncu odmerjanja opazili v študijah toksičnosti pri podganah in opicah, pokazali popolno okrevanje po koncu 60- do 90-dnevnega obdobja okrevanja, ali pa so opazili njihovo zmanjšanje, kar kaže vsaj delno reverzibilnost.
Liver and spleen were the primary target organs of toxicity in both rats and monkeys.
Jetra in vranica sta bila primarna ciljna organa toksičnosti pri podganah in opicah.
White to off-white, opalescent, homogeneous solution (pH: 6.3 - 7.5).
Bela do belkasta, opalescentna, homogena raztopina (pH: 6,3-7,5).
Pharmacotherapeutic group: Other nervous System Drugs; ATC code: N07XX12.
Farmakoterapevtska skupina: Druga zdravila z delovanjem na živčevje, oznaka ATC: N07XX12
Talk to your doctor or nurse about suitable methods of contraception.
Z zdravnikom ali medicinsko sestro se pogovorite o primernih načinih kontracepcije.
The net effect on CYP2B6 substrates (e.g., bupropion and efavirenz) in vivo is unknown.
Neto učinek zdravila na substrate CYP2B6 (npr. bupropion in efavirenz) in vivo ni znan.
• This protein is made mostly in the liver and carries vitamin A and other substances around the body.
• Ta beljakovina nastaja pretežno v jetrih in po telesu prenaša vitamin A in druge snovi.
When these reactions stop, or get better, your doctor or nurse may decide to start the infusion again.
Ko se te reakcije ustavijo ali izboljšajo, se lahko zdravnik ali medicinska sestra odloči za ponovno uvedbo infundiranja.
The diluted solution for infusion should be prepared by a healthcare professional using aseptic technique as follows:
Razredčeno raztopino za infundiranje mora pripraviti zdravstveni delavec z aseptično tehniko, kot sledi:
• Oral paracetamol (500 mg)
• peroralni paracetamol (500 mg)
Your doctor will tell you how long you need to receive Onpattro.
Zdravnik vam bo povedal, kako dolgo boste morali prejemati zdravilo Onpattro.
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 starting this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden začnete zdravljenje s tem zdravilom.
This is 0.2% of the recommended maximum daily dietary intake of sodium for an adult.
To je enako 0,2 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
In the study, 148 patients received Onpattro and 77 patients received placebo.
V študiji je 148 bolnikov prejemalo zdravilo Onpattro in 77 bolnikov placebo.
bA lower number indicates less impairment/fewer symptoms.
bManjša številka pomeni manjšo prizadetost/manj simptomov.
Due to the potential teratogenic risk arising from unbalanced vitamin A levels, Onpattro should not be used during pregnancy, unless the clinical condition of the woman requires treatment.
Zaradi možnosti tveganja za teratogenost, ki izhaja iz neuravnoteženih ravni vitamina A zdravila Onpattro ne smete uporabljati pri nosečnicah, razen če klinično stanje nosečnice zahteva zdravljenje.
Onpattro is for intravenous use.
Zdravilo Onpattro je za intravensko uporabo.
Patients experienced benefit across all TTR mutations and the full range of disease severity studied.
Koristi so imeli bolniki z vsemi mutacijami TTR in pri vseh stopnjah bolezni, ki so jih preučevali.
Onpattro has not been studied in patients with prior liver transplant; however, no dose adjustments are considered necessary.
Zdravila Onpattro niso preučili pri bolnikih s predhodno presaditvijo jeter; kljub temu se upošteva, da prilagoditve odmerkov niso potrebne.
• Withdraw the entire contents of one or more vials into a single sterile syringe.
• Celotno vsebino ene ali več vial izvlecite v eno sterilno injekcijsko brizgo.
The mean ± SD terminal elimination half-life (t1/2β) of patisiran was 3.2 ± 1.8 days.
Povprečna končna razpolovna doba izločanja patisirana ± SN (t1/2β) je bila 3,2 ± 1,8 dni.
Onpattro will reduce the level of vitamin A in your blood, which is important for normal development of your unborn child.
Zdravilo Onpattro bo v vaši krvi zmanjšalo raven vitamina A, ki je pomemben za normalen razvoj vašega nerojenega otroka.
• This means there is less TTR protein in the blood that can form amyloid.
• To pomeni, da je v telesu manj beljakovine TTR, ki lahko oblikuje amiloid.
• Leakage of the drug into the surrounding tissue at the site of infusion, which may cause swelling or redness
• iztekanje zdravila v okolno tkivo na mestu infundiranja, kar lahko povzroči oteklino ali pordelost
If you do not have problems with your infusions in the clinic, your doctor may talk with you about a healthcare professional giving you your infusions at home.
Če nimate težav z infuzijami v bolnišnici, se lahko zdravnik z zdravstvenim delavcem dogovori, da vam bo infuzije dajal doma.
Antidrug antibody titres were low and transient with no evidence of an effect on clinical efficacy, the safety profile, or the pharmacokinetic or pharmacodynamic profiles of Onpattro.
Titri protiteles proti zdravilu so bili nizki in prehodni, brez dokazanih učinkov na klinično učinkovitost, profil varnosti ali farmakokinetične ali farmakodinamične profile zdravila Onpattro.
How long to use Onpattro
Kako dolgo uporabljati zdravilo Onpattro
In the unlikely event that you are given too much (an overdose) your doctor or nurse will check you for side effects.
V malo verjetnem primeru, da boste prejeli preveč zdravila (prevelik odmerek), bosta zdravnik ali medicinska sestra preverila, ali imate neželene učinke.
Pregnancy, breast-feeding and contraception
Nosečnost, dojenje in kontracepcija
It is important to tell your doctor or nurse if you are taking any of the following medicines as your doctor may need to change the dose:
Pomembno je, da obvestite zdravnika ali medicinsko sestro, če jemljete katero od naslednjih zdravil, saj vam bo zdravnik morda moral zmanjšati odmerek:
Uncommon: may occur in up to 1 in 100 infusions
Občasni: pojavijo se lahko pri največ 1 od 100 infuzij
aAll endpoints analysed using the mixed-effect model repeated measures (MMRM) method.
aVsi opazovani dogodki so bili analizirani z uporabo metod modela mešanega učinka ponovljenih meritev (MMRM - Mixed-Effect Model Repeated Measures).
Dosing is based on actual body weight.
Odmerjanje mora temeljiti na dejanski telesni masi.
Extravasation was observed in < 0.5% of infusions in clinical studies.
Ekstravazacijo so v kliničnih študijah opazili pri < 0,5 % infuzij.
Ingredients of Onpattro may pass into breast milk.
Sestavine zdravila Onpattro lahko prehajajo v materino mleko.
The median patient age at baseline was 62 (range, 24 to 83) years and 74% of patients were male, 26% were female.
Mediana starosti bolnikov ob izhodišču je bila 62 (razpon 24 do 83) let; 74 % bolnikov je bilo moških in 26 % žensk.
• Body aches or pain, including pain in the back, neck, or joints
• telesne bolečine, vključno z bolečino v hrbtu, vratu ali sklepih
Ninetythree percent (93%) of Onpattro-treated and 62% of placebo-treated patients completed 18 months of the assigned treatment.
Triindevetdeset odstotkov (93 %) bolnikov, zdravljenih z zdravilom Onpattro, in 62 % bolnikov, ki je prejemalo placebo, je dokončalo 18 mesecev dodeljenega zdravljenja.