FrancophonIA/ELRC3.0 huggingface dataset:
English: Votubia 3 mg dispersible tablets are white to slightly yellowish, round, flat tablets with a bevelled edge and no score.
Croatian: Votubia 3 mg tablete za oralnu suspenziju su bijele do žućkaste, okrugle, plosnate tablete ukošenoga ruba bez ureza.
English: Tell your doctor if you experience symptoms of hepatitis B during treatment with everolimus.
Croatian: Ukoliko se tijekom liječenja u Vas jave simptomi hepatitisa B, obavijestite o tome svoga liječnika.
English: Using an oral syringe
Croatian: Uporaba štrcaljke za usta
English: Each dispersible tablet contains 1 mg everolimus.
Croatian: Jedna tableta za oralnu suspenziju sadrži 1 mg everolimusa.
English: Each Votubia 5 mg dispersible tablet contains 5 mg of everolimus.
Croatian: Jedna Votubia 5 mg tableta za oralnu suspenziju sadrži 5 mg everolimusa.
English: Epistaxis, pneumonitis Gastrointestinal disorders Very common Stomatitis b, diarrhoea, vomiting
Croatian: Stomatitis b, proljev, povraćanje
English: 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.
Croatian: Bijele do žućkaste, izdužene tablete dimenzija približno 15,1 x 6,0 mm, ukošenoga ruba bez ureza, s utisnutom oznakom „UHE” na jednoj te oznakom „NVR“ na drugoj strani.
English: Constipation
Croatian: Cijepljenja
English: Votubia 1 mg dispersible tablets
Croatian: Votubia 1 mg tablete za oralnu suspenziju
English: Each dispersible tablet contains 2 mg everolimus.
Croatian: Jedna tableta za oralnu suspenziju sadrži 2 mg everolimusa.
English: Temporary dose interruption until recovery to Grade 1.
Croatian: Stupanj 2 Privremeni prekid primjene do oporavka do stupnja 1. Ponovno započeti primjenu Votubie u istoj dozi.
English: Votubia 3 mg and Votubia 5 mg dispersible tablets are available in packs containing 30 x 1 or 100 x1 dispersible tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Croatian: Votubia 3 mg i 5 mg tablete za oralnu suspenziju dostupne su u pakiranjima od 30 x 1 ili 100 x 1 tableta za oralnu suspenziju u perforiranim blisterima s jediničnim dozama koji sadrže 10 x 1 tabletu.
English: Packs containing 10 x 1, 30 x 1 or 100 x 1 dispersible tablets.
Croatian: Pakiranja sadrže 10 x 1, 30 x 1 ili 100 x 1 tabletu za oralnu suspenziju.
English: Votubia 5 mg dispersible tablets, abbreviated form accepted, if required for technical reasons
Croatian: Votubia 5 mg tablete za oralnu suspenziju, skraćena verzija [tbl. za oral. susp.] prihvaćena, ako je potrebno zbog tehničkih razloga
English: Votubia 1 mg dispersible tablets everolimus
Croatian: Votubia 1 mg tablete za oralnu suspenziju everolimus
English: 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.
Croatian: Bijele do žućkaste, izdužene tablete dimenzija približno 12,1 x 4,9 mm, ukošenoga ruba bez ureza, s utisnutom oznakom „5” na jednoj te oznakom „NVR“ na drugoj strani.
English: They are engraved with “D5” on one side and “NVR” on the other.
Croatian: Na jednoj strani utisnuta je oznaka „D5“, a na drugoj oznaka „NVR“.
English: 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.
Croatian: Votubia 10 mg tablete dostupne su u pakiranjima od 10 x 1, 30 x 1 ili 100 x 1 tableta u perforiranim blisterima s jediničnim dozama koji sadrže 10 x 1 tabletu.
English: • 2 clean glasses • Approximately 30 ml of water
Croatian: • Približno 30 ml vode klip trup oznake volumena vrh
English: 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.
Croatian: Votubia 2,5 mg tablete dostupne su u pakiranjima od 10 x 1, 30 x 1 ili 100 x 1 tableta u perforiranim blisterima s jediničnim dozama koji sadrže 10 x 1 tabletu.
English: 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.
Croatian: Votubia 5 mg tablete dostupne su u pakiranjima od 30 x 1 ili 100 x 1 tableta u perforiranim blisterima s jediničnim dozama koji sadrže 10 x 1 tabletu.
English: Each dispersible tablet contains 3 mg everolimus.
Croatian: Jedna tableta za oralnu suspenziju sadrži 3 mg everolimusa.
English: Plasma protein binding is approximately 74% both in healthy subjects and in patients with moderate hepatic impairment.
Croatian: I u zdravih ispitanika i u bolesnika s umjerenim oštećenjem funkcije jetre, postotak vezanja everolimusa za proteine plazme iznosi 74%.
English: Votubia 2 mg dispersible tablets
Croatian: Votubia 2 mg tablete za oralnu suspenziju
English: Votubia 1 mg dispersible tablets, abbreviated form accepted, if required for technical reasons
Croatian: Votubia 1 mg tablete za oralnu suspenziju, skraćena verzija [tbl. za oral. susp.] prihvaćena, ako je potrebno zbog tehničkih razloga
English: Votubia 2 mg dispersible tablets everolimus
Croatian: Votubia 2 mg tablete za oralnu suspenziju everolimus
English: Votubia 2 mg dispersible tablets, abbreviated form accepted, if required for technical reasons
Croatian: Votubia 2 mg tablete za oralnu suspenziju, skraćena verzija [tbl. za oral. susp.] prihvaćena, ako je potrebno zbog tehničkih razloga
English: Votubia 3 mg dispersible tablets everolimus
Croatian: Votubia 3 mg tablete za oralnu suspenziju everolimus
English: Cmax is dose-proportional between 5 and 10 mg. Everolimus is a substrate and moderate inhibitor of PgP.
Croatian: U rasponu doza od 5 do 10 mg, Cmax je razmjeran dozi.
English: They are engraved with “D3” on one side and “NVR” on the other.
Croatian: Na jednoj strani utisnuta je oznaka „D3“, a na drugoj oznaka „NVR“.
English: Votubia 3 mg dispersible tablets, abbreviated form accepted, if required for technical reasons
Croatian: Votubia 3 mg tablete za oralnu suspenziju, skraćena verzija [tbl. za oral. susp.] prihvaćena, ako je potrebno zbog tehničkih razloga
English: They are engraved with “D1” on one side and “NVR” on the other.
Croatian: Na jednoj strani utisnuta je oznaka „D1“, a na drugoj oznaka „NVR“.
English: 10 x 1 dispersible tablets 30 x 1 dispersible tablets 100 x 1 dispersible tablets
Croatian: 10 x 1 tableta za oralnu suspenziju 30 x 1 tableta za oralnu suspenziju 100 x 1 tableta za oralnu suspenziju
English: They are engraved with “D2” on one side and “NVR” on the other.
Croatian: Na jednoj strani utisnuta je oznaka „D2“, a na drugoj oznaka „NVR“.
English: Reduction from baseline
Croatian: Smanjenje od početne vrijednosti
English: 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.
Croatian: Bijele do žućkaste, okrugle, plosnate tablete promjera približno 12,1 mm, ukošenoga ruba bez ureza, s utisnutom oznakom „D5“ na jednoj te oznakom „NVR“ na drugoj strani.
English: Crospovidone type A Mannitol
Croatian: Bjelančevine u mokraći
English: Hepatic impairment
Croatian: A laktoza, bezvodna
English: It is essential to assess everolimus blood levels in cases of suspected overdose.
Croatian: Pri sumnji na predoziranje od ključnog je značaja odrediti razinu everolimusa u krvi.
English: Votubia 3 mg dispersible tablets
Croatian: Votubia 3 mg tablete za oralnu suspenziju
English: Age
Croatian: Progresija
English: If toxicity recurs at Grade 2, interrupt Votubia until recovery to Grade 1.
Croatian: Ako se vrati toksičnost stupnja 2, prekinuti primjenu Votubie do oporavka do stupnja 1. Ponovno započeti primjenu Votubie u dozi koja je otprilike 50% niža od prethodno primjenjivane dnevne doze.
English: 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.
Croatian: Bijele do žućkaste, okrugle, plosnate tablete promjera približno 7,1 mm, ukošenoga ruba bez ureza, s utisnutom oznakom „D1” na jednoj te oznakom „NVR” na drugoj strani.
English: 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.
Croatian: Bijele do žućkaste, okrugle, plosnate tablete promjera približno 10,1 mm, ukošenoga ruba bez ureza, s utisnutom oznakom „D3“ na jednoj te oznakom „NVR“ na drugoj strani.
English: 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.
Croatian: Votubia 2 mg tablete za oralnu suspenziju dostupne su u pakiranjima od 10 x 1, 30 x 1 ili 100 x 1 tabletu za oralnu suspenziju u perforiranim blisterima s jediničnim dozama koji sadrže 10 x 1 tabletu.
English: 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.
Croatian: Bijele do žućkaste, okrugle, plosnate tablete promjera približno 9,1 mm, ukošenoga ruba bez ureza, s utisnutom oznakom „D2“ na jednoj te oznakom „NVR“ na drugoj strani.
English: 30 x 1 dispersible tablets 100 x 1 dispersible tablets
Croatian: 30 x 1 tableta za oralnu suspenziju 100 x 1 tableta za oralnu suspenziju
English: If stomatitis recurs at Grade 2, interrupt dose until recovery to Grade 1.
Croatian: Ako se vrati stomatitis stupnja 2, prekinuti primjenu do oporavka do stupnja 1. Ponovno započeti primjenu Votubie u dozi koja je otprilike 50% niža od prethodno primjenjivane dnevne doze.
English: 100 x 1 dispersible tablets
Croatian: 100 x 1 tableta za oralnu suspenziju
English: Votubia 5 mg dispersible tablets everolimus
Croatian: Votubia 5 mg tablete za oralnu suspenziju everolimus
English: Each dispersible tablet contains 5 mg everolimus.
Croatian: Jedna tableta za oralnu suspenziju sadrži 5 mg everolimusa.
English: 30 x 1 dispersible tablets
Croatian: 30 x 1 tableta za oralnu suspenziju
English: Caution should therefore be exercised with the use of Votubia in the peri-surgical period.
Croatian: Potreban je oprez pri primjeni Votubie neposredno prije i poslije kirurškog zahvata.
English: Lymphoedema
Croatian: gingivitis
English: • Spoon for stirring
Croatian: • Žlica za miješanje
English: The parent substance was not detected in urine or faeces.
Croatian: Ni u mokraći ni u stolici nije nađena ishodišna tvar.
English: The suspension must be administered immediately after preparation.
Croatian: Suspenziju se mora popiti odmah nakon pripreme.
English: 10 x 1 dispersible tablets
Croatian: 10 x 1 tableta za oralnu suspenziju
English: SEGA response rate 95% CI Best overall SEGA response - (%) Response Stable disease Progression Not evaluable according to independent central radiology review SEGA responses were confirmed with a repeat scan.
Croatian: Najbolji ukupni odgovor SEGA-e - (%) Odgovor Stabilna bolest Progresija
English: All medicines listed above should be avoided during your treatment with Votubia.
Croatian: Tijekom liječenja Votubiom, sve gore navedene lijekove potrebno je izbjegavati.
English: SEGA patients receiving concomitant potent CYP3A4 inducers may require an increased Votubia dose to achieve
Croatian: U bolesnika sa SEGA-om koji istodobno uzimaju potentne induktore CYP3A4 može se ukazati potreba za povišenjem doze Votubie u cilju postizanja iste izloženosti kao i u bolesnika koji ne uzimaju potentne induktore.
English: These signs are listed at the beginning of section 4.
Croatian: Ti su znakovi navedeni na početku dijela 4.
English: Gender and race
Croatian: Spol i rasa
English: Primary mNIS+7b
Croatian: Primarna mNIS+7b
English: Your healthcare professional will throw away any medicines that are no longer being used.
Croatian: Vaš će zdravstveni radnik baciti lijekove koji se više ne koriste.
English: • This can help to reduce the effects of this illness.
Croatian: • Na taj način pomaže se ublažavanju učinaka ove bolesti.
English: • Amyloid can build up around the nerves, heart, and other places in the body, preventing them from working normally.
Croatian: • Amiloid se može nakupiti oko živaca, srca i na drugim mjestima u tijelu, sprečavajući njihov normalan rad.
English: What Onpattro is and what it is used for
Croatian: Što je Onpattro i za što se koristi
English: Onpattro is used in adults only.
Croatian: Onpattro se primjenjuje samo u odraslih.
English: Your doctor may refer you to an eye specialist for a check-up if it is necessary.
Croatian: Liječnik Vas može poslati na pregled specijalistu za oči ako je to potrebno.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego što primite ovaj lijek jer sadrži Vama važne podatke.
English: This causes the symptoms of the illness.
Croatian: Na taj način nastaju simptomi bolesti.
English: Do not mix or dilute with other medicinal products.
Croatian: Nemojte miješati ili razrjeđivati s drugim lijekovima.
English: The educational material for patients (a home infusion guide detailing the steps to undertake during home infusion) should include information about:
Croatian: Edukacijski materijal za bolesnike (vodič za davanje infuzije kod kuće s detaljnim opisom koraka koje treba provesti tijekom davanja infuzije kod kuće) treba uključiti informacije o:
English: 1077 ZX Amsterdam Netherlands
Croatian: 1077 ZX Amsterdam Nizozemska
English: • if you have ever had a severe allergic reaction to patisiran, or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste ikad imali tešku alergijsku reakciju na patisiran ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Dosing is based on actual body weight.
Croatian: Doziranje se određuje prema stvarnoj tjelesnoj težini.
English: From a microbiological point of view, it is recommended that the product should be used immediately.
Croatian: S mikrobiološkog stajališta, preporučuje se odmah primijeniti lijek.
English: For patients weighing ≥ 100 kg, the maximum recommended dose is 30 mg.
Croatian: Za bolesnike težine ≥ 100 kg, maksimalna preporučena doza je 30 mg.
English: Children and adolescents Onpattro is not recommended in children and adolescents under 18 years of age.
Croatian: Onpattro se ne preporučuje djeci i adolescentima mlađim od 18 godina.
English: Extravasation was observed in < 0.5% of infusions in clinical studies.
Croatian: Ekstravazacija je opažena kod < 0,5 % infuzija u kliničkim ispitivanjima.
English: The diluted solution for infusion should be prepared by a healthcare professional using aseptic technique as follows:
Croatian: Razrijeđenu otopinu za infuziju treba pripremiti zdravstveni radnik koristeći se aseptičnom tehnikom kako slijedi:
English: The safety and efficacy of Onpattro in children or adolescents < 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Onpattro u djece ili adolescenata u dobi od < 18 godina nije ustanovljena.
English: 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.
Croatian: Ako nemate problema s infuzijama u klinici, Vaš liječnik će s Vama razgovarati o mogućnosti da Vam zdravstveni radnik daje infuzije kod kuće.
English: Table 2: Clinical Efficacy Results from the Placebo-Controlled Study
Croatian: Tablica 2: Rezultati kliničke djelotvornosti iz placebom kontroliranog ispitivanja
English: Your doctor will tell you how long you need to receive Onpattro.
Croatian: Vaš će Vam liječnik objasniti koliko dugo trebate primati Onpattro.
English: No formal clinical drug interaction studies have been performed.
Croatian: Nisu provedena službena klinička ispitivanja interakcija lijekova.
English: • Remove Onpattro from the refrigerator.
Croatian: • Izvadite Onpattro iz hladnjaka.
English: This leaflet was last revised in MM/YYYY.
Croatian: Ova uputa je zadnji put revidirana u MM/GGGG.
English: Infusion-related reactions Infusion-related reactions are very common (may affect more than 1 in 10 people).
Croatian: Reakcije povezane s infuzijom vrlo su česte (mogu se javiti kod više od 1 od 10 osoba).
English: • Requirements for home infusion, including availability and timely administration of the appropriate premedication;
Croatian: • zahtjevima prilikom davanja infuzije kod kuće, uključujući dostupnost i pravovremenu primjenu odgovarajuće premedikacije
English: 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.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego što uzmete ovaj lijek.
English: Benefits relative to placebo were also observed across all mNIS+7 components.
Croatian: Koristi u odnosu na placebo zabilježene su također u svim komponentama mNIS+7.
English: Medicines should not be disposed of via wastewater or household waste.
Croatian: Lijekovi se ne smiju bacati u otpadne vode ili kućni otpad.
English: • It is given as a drip into a vein (‘intravenous infusion') usually over about 80 minutes.
Croatian: • Daje se kapanjem u venu (u obliku‚ intravenske infuzije'), obično tijekom približno 80 minuta.
English: The net effect on CYP2B6 substrates (e.g., bupropion and efavirenz) in vivo is unknown.
Croatian: Neto učinak na supstrate CYP2B6 (npr. bupropion i efavirenz) in vivo nije poznat.
English: • Low or high blood pressure
Croatian: • sniženi ili povišeni krvni tlak
English: Greater than 95% of patisiran in the circulation is associated with lipid nanoparticles.
Croatian: Više od 95 % patisirana u krvotoku povezano je s lipidnim nanočesticama.
English: Patisiran is metabolized by nucleases to nucleotides of various lengths.
Croatian: Patisiran se metabolizira posredstvom nukleaza u nukleotide različitih duljina.
English: This is 0.2% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To je 0,2 % preporučenog maksimalnog dnevnog unosa natrija u prehrani odrasle osobe.
English: Onpattro will reduce the level of vitamin A in your blood, which is important for normal development of your unborn child.
Croatian: Onpattro će Vam smanjiti razinu vitamina A u krvi, što je važno za normalan razvoj Vašeg nerođenog djeteta.
English: If you have problems with your vision or any other eye problems whilst using Onpattro, you should talk to your doctor.
Croatian: Ako imate problema s vidom ili bilo kakve druge probleme s očima dok uzimate lijek Onpattro, morate se obratiti svojem liječniku.
English: What Onpattro looks like and contents of the pack
Croatian: Kako Onpattro izgleda i sadržaj pakiranja
English: ADOH B.V., NIJMEGEN Godfried Bomansstraat 31 6543 JA Nijmegen Netherlands
Croatian: ADOH B.V., NIJMEGEN Godfried Bomansstraat 31 6543 JA Nijmegen Nizozemska
English: Luxembourg/Luxemburg, Magyarország, Malta, Norge, Polska, România, Slovenija, Slovenská republika, Suomi/Finland Alnylam Netherlands B.V.
Croatian: België/Belgique/Belgien, България, Česká republika, Danmark, Eesti, Ελλάδα, Hrvatska, Ireland, Ísland, Κύπρος, Latvija, Lietuva, Luxembourg/Luxemburg, Magyarország, Malta, Norge, Polska, România, Slovenija, Slovenská republika, Suomi/Finland Alnylam Netherlands B.V.
English: Infusion of Onpattro at home may be considered for patients who have tolerated at least 3 infusions well in the clinic.
Croatian: Infuzija lijeka Onpattro kod kuće moguća je za bolesnike koji su u klinici dobro podnijeli najmanje 3 infuzije.
English: • Onpattro does not contain preservatives.
Croatian: • Onpattro ne sadrži konzervanse.
English: Other medicines and Onpattro
Croatian: Ostali lijekovi i Onpattro
English: • Your doctor will work out how much Onpattro to give you - this will depend on your body weight.
Croatian: • Vaš liječnik će odrediti koliko ćete lijeka Onpattro primiti - to će ovisiti o Vašoj tjelesnoj težini.
English: • The active substance is patisiran.
Croatian: • Djelatna tvar je patisiran.
English: Very common: may affect more than 1 in 10 people • Swelling of the arms or legs (peripheral oedema)
Croatian: Vrlo česte: mogu se javiti u više od 1 na 10 osoba • oticanje ruku ili nogu (periferni edem)
English: Onpattro did not exhibit a genotoxic potential in vitro and in vivo and was not carcinogenic in transgenic rasH2 mice.
Croatian: Onpattro nije pokazao genotoksični potencijal in vitro i in vivo i nije bio kancerogen kod transgeničnih miševa RasH2.
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svojeg liječnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Pharmacotherapeutic group: Other nervous System Drugs; ATC code: N07XX12.
Croatian: Farmakoterapijska skupina: Ostali lijekovi koji djeluju na živčani sustav; ATK oznaka:.N07XX12
English: • Risk Management Plan (RMP)
Croatian: PRIMJENU LIJEKA • Plan upravljanja rizikom (RMP)
English: The decision for a patient to receive home infusions should be made after evaluation and recommendation by the treating physician.
Croatian: Odluka da bolesnik prima infuziju kod kuće treba se donijeti nakon procjene i preporuke liječnika.
English: Chemical and physical in-use stability has been demonstrated for 16 hours at room temperature (up to 30°C).
Croatian: Dokazana kemijska i fizička stabilnost lijeka u primjeni je 16 sati na sobnoj temperaturi (do 30 °C).
English: • Very common (≥ 1/10)
Croatian: • Vrlo često (≥ 1/10)
English: • Oral paracetamol (500 mg)
Croatian: • Oralni paracetamol (500 mg)
English: • This means there is less TTR protein in the blood that can form amyloid.
Croatian: • To znači da u krvi ima manje proteina TTR koji mogu stvoriti amiloid.
English: 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:
Croatian: Važno je da se obratite liječniku ili medicinskoj sestri ako uzimate neki od sljedećih lijekova, jer će Vam liječnik možda trebati promijeniti dozu:
English: • Withdraw the entire contents of one or more vials into a single sterile syringe.
Croatian: • Izvucite cjelokupni sadržaj jedne ili više bočica u jednu sterilnu štrcaljku.
English: • Irritation or infection of the airways (sinusitis, bronchitis)
Croatian: • nadraženost ili infekcija dišnih puteva (sinusitis, bronhitis)
English: • Body aches or pain, including pain in the back, neck, or joints
Croatian: • bolovi u tijelu, uključujući bol u leđima, vratu ili zgobovima
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 August 2018
Croatian: Datum prvog odobrenja: 27. kolovoza 2018.
English: Prior to the launch of Onpattro 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).
Croatian: Prije stavljanja lijeka Onpattro u promet u svakoj državi članici, nositelj odobrenja (MAH) mora s nacionalnim nadležnim tijelom dogovoriti sadržaj i oblik edukacijskih materijala uključujući načine priopćavanja, modalitete distribucije i druge aspekte programa.
English: The mean ± SD terminal elimination half-life (t1/2β) of patisiran was 3.2 ± 1.8 days.
Croatian: Srednja vrijednost ± SD terminalnog poluvremena eliminacije (t1/2β) patisirana bila je 3,2 ± 1,8 dana.
English: This medicinal product is for single-use only.
Croatian: Ovaj lijek namijenjen je samo za jednokratnu uporabu.
English: Liver and spleen were the primary target organs of toxicity in both rats and monkeys.
Croatian: Jetra i slezena bile su primarni ciljni organi toksičnosti i kod štakora i kod majmuna.
English: Genotoxicity/Carcinogenicity
Croatian: Genotoksičnost/kancerogenost
English: White to off-white, opalescent, homogeneous solution (pH: 6.3 - 7.5).
Croatian: Bijela do bjelkasta, opalescentna, homogena otopina (pH vrijednosti 6,3 - 7,5).