natgillin/translations-raw huggingface dataset:
The concomitant use of Entresto with aliskiren-containing products is contraindicated in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73 m2) (see section 4.3).
Istodobna primjena Entresta i lijekova koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolesti ili u bolesnika s oštećenjem bubrega (eGFR <60 ml/min/1,73 m2) (vidjeti dio 4.3).
Entresto 24 mg/26 mg film-coated tablets Hypromellose, substitution type 2910 (3 mPa·s) Titanium dioxide (E171) Macrogol 4000
Entresto 24 mg/26 mg filmom obložene tablete Hipromeloza, supstitucijski tip 2910 (3 mPa s) Titanijev dioksid (E171) Makrogol 4000
Entresto 97 mg/103 mg tablets sacubitril/valsartan
Entresto 97 mg/103 mg tablete sakubitril/valsartan
Entresto 24 mg/26 mg tablets sacubitril/valsartan
Entresto 24 mg/26 mg tablete sakubitril/valsartan
Approximate tablet dimensions 13.1 mm x 5.2 mm Entresto 97 mg/103 mg film-coated tablets are light pink oval tablets with “NVR” on one side and “L11” on the other side.
Entresto 97 mg/103 mg filmom obložene tablete su svijetlo ružičaste ovalne tablete s oznakom „NVR“ s jedne strane i „L11“ s druge strane.
Entresto 24 mg/26 mg film-coated tablets sacubitril/valsartan
Entresto 24 mg/26 mg filmom obložene tablete sakubitril/valsartan
Entresto 97 mg/103 mg film-coated tablets sacubitril/valsartan
Entresto 97 mg/103 mg filmom obložene tablete sakubitril/valsartan
Entresto 49 mg/51 mg tablets sacubitril/valsartan
Entresto 49 mg/51 mg tablete sakubitril/valsartan
If you stop taking Entresto, wait 36 hours after taking your last dose of Entresto before starting an ACE inhibitor.
Ako prestanete uzimate Entresto, pričekajte 36 sati nakon uzimanja posljednje doze Entresta prije nego počnete uzimati ACE inhibitor (vidjeti „Uzimanje drugih lijekova“).
Entresto 49 mg/51 mg film-coated tablets sacubitril/valsartan
Entresto 49 mg/51 mg filmom obložene tablete sakubitril/valsartan
A slight increase in two foetal skeletal variations (misshapen sternebra, sternebra bipartite ossification) was observed in rabbits at an Entresto dose of
Blago povećanje dviju varijacija fetusnog skeleta (deformirana sternebra, dvostrana osifikacija sternebre) bilo je uočeno u zečeva pri dozi Entresta od 4,9 mg sakubitrila/5,1 mg valsartana/kg/dan.
The infusion lasts 2 hours.
Infuzija mora trajati 2 sata.
This reduces bone loss.
Time se smanjuje gubitak kostiju.
Patients should also take vitamin D and calcium supplements.
Bolesnici također moraju uzimati vitamin D i dodatke kalcija.
It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Objašnjava kako je Agencija procijenila lijek da bi preporučila njegovo odobrenje u EU-u te uvjete za njegovu primjenu.
The full EPAR for Ibandronic acid Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Ibandronatna kiselina Accord nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for the reference medicines can also be found on the Agency's website.
Cjeloviti EPAR za referentne lijekove nalazi se i na internetskim stranicama Agencije.
This will normally bring the blood calcium level down to normal levels within a week.
To u pravilu razine kalcija u krvi vraća u normalu unutar tjedan dana.
This means that Ibandronic acid Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU).
To znači da Ibandronatna kiselina Accord sadržava istu djelatnu tvar i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU).
For the prevention of skeletal events or the treatment of hypercalcaemia in cancer patients, treatment with this medicine should only be started by a doctor who has experience in the treatment of cancer.
Za sprječavanje koštanih problema ili liječenje hiperkalcemije u oboljelih od raka, terapiju ovim lijekom može započeti samo liječnik s iskustvom u liječenju raka.
• prevent ‘skeletal events' (fractures or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone);
• sprječavanje „koštanih problema” (fraktura ili komplikacija s kostima koje zahtijevaju liječenje u bolesnika s rakom dojke i metastazama u kostima (kad se rak proširio na kosti);
• treat hypercalcaemia (high levels of calcium in the blood) caused by tumours.
• liječenje hiperkalcemije (visoke razine kalcija u krvi) koju uzrokuju tumori.
Its effect in reducing the risk of spine fractures has been shown in studies, but its effect on the risk of fractures of the neck of the femur (the top of the thighbone) has not been established.
Njegov učinak na smanjenje rizika od fraktura kralježnice utvrđen je u ispitivanjima, no učinak dotičnog lijeka na rizik od fraktura vrha femura (bedrene kosti) nije utvrđen.
Patients with tumours can have high levels of calcium in their blood, released from the bones.
Bolesnici s tumorima mogu imati visoke količine kalcija u krvi koji se izlučuje iz kostiju.
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicines, Bondronat and Bonviva, and do not need to be repeated for Ibandronic acid Accord.
Ispitivanja o koristima i rizicima djelatne tvari pri odobrenoj primjeni već su provedena za referentne lijekove, Bondronat i Bonviva, te ih ne treba ponavljati za lijek Ibandronatna kiselina Accord.
As for every medicine, the company provided studies on the quality of Ibandronic acid Accord.
Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Ibandronatna kiselina Accord.
Because Ibandronic acid Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicines'.
Budući da je Ibandronatna kiselina Accord generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnih lijekova.
The European Medicines Agency concluded that, in accordance with EU requirements, Ibandronic acid Accord has been shown to be comparable to Bondronat and Bonviva.
Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, potvrđeno da je lijek Ibandronatna kiselina Accord usporediv s lijekovima Bondronat i Bonviva.
Osteonecrosis of the jaw is a condition affecting the bones of the jaw, which could lead to pain, sores in the mouth or loose teeth.
Osteonekroza čeljusti poremećaj je koji utječe na čeljusne kosti, što može uzrokovati bolove, rane u ustima ili klimanje zubi.
It stops the action of osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Zaustavlja aktivnost osteoklasta, stanica u tijelu koje su uključene u razgradnju koštanog tkiva.
There was no need for ‘bioequivalence' studies to investigate whether Ibandronic acid Accord is absorbed similarly to the reference medicines to produce the same level of the active substance in the blood.
Nije bilo potrebe za ispitivanjima bioekvivalencije kako bi se istražilo apsorbira li se Ibandronatna kiselina Accord na sličan način kao i referentni lijekovi radi proizvodnje jednake razine djelatne tvari u krvi.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ibandronic acid Accord have also been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Ibandronatna kiselina Accord također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
For the treatment of osteoporosis, Ibandronic acid Accord is given as an injection into a vein once every three months.
Za liječenje osteoporoze, Ibandronatna kiselina Accord daje se kao injekcija u venu jednom svaka tri mjeseca.
By preventing the breakdown of bones, Ibandronic acid Accord also helps to reduce the amount of calcium released into the blood.
Sprječavanjem razgradnje kostiju, ibandronatna kiselina također doprinosi smanjenju količine kalcija koji se izlučuje u krv.
Ibandronic acid Accord is available as a solution for injection (3 mg) in a pre-filled syringe and as a concentrate (2 mg and 6 mg) to be made up into a solution for infusion (drip) into a vein.
Lijek Ibandronatna kiselina Accord dostupan je u obliku otopine za injekciju (3 mg) u napunjenoj brizgalici i kao koncentrat (2 mg i 6 mg) za pripremu otopine za infuziju (drip) u venu.
The European Commission granted a marketing authorisation valid throughout the European Union for Ibandronic acid Accord on 19 November 2012.
Europska komisija izdala je odobrenje za stavljanje u promet lijeka Ibandronatna kiselina Accord koje vrijedi na prostoru Europske unije od 19. studenoga 2012.
Ibandronic acid Accord concentrate for solution for infusion (drip) is used in adults to:
Koncentrat za otopinu za infuziju (drip) Ibandronatna kiselina Accord koristi se u odraslih za:
The company that markets Ibandronic acid Accord will provide a card to inform patients receiving Ibandronic acid Accord infusion about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they get symptoms.
Tvrtka koja lijek Ibandronatna kiselina Accord stavlja u promet osigurat će karticu s informacijama za bolesnike koji primaju infuziju lijeka Ibandronatna kiselina Accord o rizicima osteonekroze čeljusti te s uputama da kontaktiraju svojeg liječnika u slučaju pojave simptoma.
This is a summary of the European public assessment report (EPAR) for Ibandronic acid Accord.
Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Ibandronatna kiselina Accord.
Ibandronic acid Accord solution for injection is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures (breaks).
Otopina za injekciju Ibandronatna kiselina Accord koristi se za liječenje osteoporoze (bolesti koja kosti čini krhkima) u žena koje su prošle menopauzu i izložene su riziku razvoja fraktura (lomova) kostiju.
In the treatment of hypercalcaemia caused by tumours, Ibandronic acid Accord is given into a vein as an infusion of 2 or 4 mg, depending on how severe the hypercalcaemia is.
U liječenju hiperkalcemije uzrokovane tumorima, Ibandronatna kiselina Accord daje se u venu kao infuzija od 2 mg ili 4 mg, ovisno o težini hiperkalcemije.
This is because Ibandronic acid Accord is given by infusion or injection into a vein, so the active substance is delivered straight into the bloodstream.
Razlog tome je činjenica da se Ibandronatna kiselina Accord daje infuzijom ili injekcijom u venu te djelatna tvar odmah ulazi u krvotok.
In the prevention of skeletal events in patients with breast cancer and bone metastases, Ibandronic acid Accord is given into a vein as a 6 mg infusion lasting at least 15 minutes every three to four weeks.
Za sprječavanje koštanih problema u bolesnika s rakom dojke i metastazama u kostima, Ibandronatna kiselina Accord daje se u venu kao infuzija od 6 mg u trajanju od barem 15 minuta svaka tri do četiri tjedna.
What measures are being taken to ensure the safe and effective use of Ibandronic acid Accord?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ibandronatna kiselina Accord?
For more information about treatment with Ibandronic acid Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Ibandronatna kiselina Accord pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
Other information about Ibandronic acid Accord
Ostale informacije o lijeku Ibandronatna kiselina Accord
It is not intended to provide practical advice on how to use Ibandronic acid Accord.
Svrha sažetka nije davati praktične savjete o korištenju lijeka Ibandronatna kiselina Accord.
Ibandronic acid Accord is a medicine used to treat certain conditions affecting bones and blood calcium.
Ibandronatna kiselina Accord lijek je kojim se liječe određena stanja koja utječu na kalcij u kostima i krvi.
The Agency recommended that Ibandronic acid Accord be approved for use in the EU.
Agencija je preporučila izdavanje odobrenja za stavljanje u promet lijeka Ibandronatna kiselina Accord u EU-u.
What is Ibandronic acid Accord and what is it used for?
Što je Ibandronatna kiselina Accord i za što se koristi?
What are the benefits and risks of Ibandronic acid Accord?
Koje su koristi i rizici od lijeka Ibandronatna kiselina Accord?
The reduction of bone loss helps to make bones less likely to break in cancer patients with bone metastases and in women with osteoporosis.
Smanjenje gubitka kostiju umanjuje i mogućnost lomova kostiju u oboljelih od raka s metastazama u kostima te u žena s osteoporozom.
Ibandronic acid Accord contains the active substance ibandronic acid and is a ‘generic medicine'.
Ibandronatna kiselina Accord sadržava djelatnu tvar ibandronatnu kiselinu te je „generički lijek”.
Patients with moderate or severe kidney problems should receive Ibandronic acid Accord infusions at a lower dose over an hour.
Bolesnici s umjerenim do teškim bubrežnim problemima trebaju primiti infuzije lijeka u manjim dozama u trajanju od preko sat vremena.
For practical information about using Ibandronic acid Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Praktične informacije o primjeni lijeka Ibandronatna kiselina Accord bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
The active substance in Ibandronic acid Accord, ibandronic acid, is a bisphosphonate.
Djelatna tvar lijeka Ibandronatna kiselina Accord, ibandronatna kiselina, je biofosfonat.
The reference medicines for Ibandronic acid Accord are Bondronat and Bonviva.
Referentni lijekovi za lijek Ibandronatna kiselina Accord su Bondronat i Bonviva.
Therefore, the Agency's view was that, as for Bondronat and Bonviva, the benefit outweighs the identified risk.
Stoga je stav Agencije da korist nadmašuje identificirani rizik, kao i za lijekove Bondronat i Bonviva.
Ibandronic acid Accord ibandronic acid
Ibandronatna kiselina Accord ibandronatna kiselina
Why is Ibandronic acid Accord approved?
Zašto je lijek Ibandronatna kiselina Accord odobren?
How is Ibandronic acid Accord used?
Kako se Ibandronatna kiselina Accord koristi?
How does Ibandronic acid Accord work?
Kako djeluje Ibandronatna kiselina Accord?
How has Ibandronic acid Accord been studied?
Kako je Ibandronatna kiselina Accord ispitivan?
Concentrate: 1.5ml Solvent: 4.5 ml
koncentrat: 1,5 ml; otapalo: 4,5 ml
EU/1/11/676/001Jevtana 60 mg Concentrate and solvent for solution for infusion
EU/1/11/676/001 Jevtana
Strength Pharmaceutical Form Route of Administration
Doza Farmaceutski oblik Način primjene Unutarnje pakovanje
Intravenous use Concentrate: vial (glass) Solvent: vial (glass)
Za primjenu u venu koncentrat: bočica (staklo); otapalo: bočica (staklo)
(Invented) name
EU broj odobrenja (Zaštićeni) naziv lijeka
Date of first authorisation: 26 July 2017
Datum prvog odobrenja: 26 srpanj 2017
What Vosevi is and what it is used for
Što je Vosevi i za što se koristi
• Your doctor can decide if you should take Vosevi and for how long;
• Vaš liječnik može odlučiti trebate li uzimati lijek Vosevi i koliko dugo;
STIMULANTS Modafinil
STIMULANSI Modafinil
d. These are medicinal products within class where similar interactions could be predicted.
d. Ovo su lijekovi iz skupine u kojoj se mogu predvidjeti slične interakcije.
f. Data obtained from transiently transfected replicons.
f. Podaci dobiveni iz prolazno transficiranih replikona.
The human relevance of this finding is not known.
Značajnost tog otkrića za ljude nije poznata.
If you take more Vosevi than you should
Ako uzmete više lijeka Vosevi nego što ste trebali
Total bilirubin
Ukupni bilirubin
No effect = 1.00. b. All interaction studies conducted in healthy volunteers.
b. Sva ispitivanja interakcija provedena su u zdravih dobrovoljaca.
e. Bioequivalence/Equivalence boundary 80-125%.
e. Granica bioekvivalencije/ekvivalencije 80 %-125 %.
Contact your doctor or nearest emergency department immediately for advice.
Odmah se obratite svom liječniku ili otiđite u najbližu hitnu službu po savjet.
Swallow the tablet whole with food.
Tabletu progutajte cijelu s hranom.
Recommended dose The recommended dose is one tablet once a day for 8 or 12 weeks.
Preporučena doza Preporučena doza je jedna tableta jedanput na dan tijekom 8 ili 12 tjedana.
If this applies to you, do not take Vosevi and tell your doctor immediately.
Ako se ovo odnosi na Vas, nemojte uzimati lijek Vosevi i odmah obavijestite svog liječnika.
The overall SVR12 rate was 100% (31/31).
Ukupna SVR12 stopa bila je 100 % (31/31).
The median time to re-treatment was 414 days (range 1981271).
Medijan vremena do ponovnog liječenja bio je 414 dana (raspon od 198 do 1271).
Alternative methods of contraception (e.g. progestin only contraception or non-hormonal methods) should be considered.
Treba razmotriti alternativne metode kontracepcije (npr. kontracepcija samo progestinom ili nehormonska kontracepcija).
• Your doctor can confirm that your treatment has worked and you are free of the hepatitis C virus.
• Vaš liječnik može potvrditi da Vam liječenje djeluje i da više nemate virus hepatitisa C.
Titanium dioxide (E171)
talk titanijev dioksid (E171)
Use with certain HIV antiretroviral regimens
Primjena s određenim antiretrovirusnim režimima za HIV
Other medicines and Vosevi
Drugi lijekovi i Vosevi
If you are pregnant, think you may be pregnant, are breast-feeding your baby, or are planning to have a baby ask your doctor for advice before taking this medicine.
Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
NA: Not available
ND = nije dostupno
If you do miss a dose, work out how long it is since you last took your Vosevi:
Ako propustite uzeti dozu, izračunajte koliko je vremena prošlo otkad ste zadnji put uzeli lijek Vosevi:
Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); or uncommon (≥ 1/1000 to < 1/100).
Učestalosti se definiraju na sljedeći način: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10), ili manje često (≥ 1/1000 do
These medicines can decrease the amount of Vosevi in your blood.
Ovi lijekovi mogu smanjiti količinu lijeka Vosevi u Vašoj krvi.
What Vosevi looks like and contents of the pack
Kako Vosevi izgleda i sadržaj pakiranja
Treatment of overdose with Vosevi consists of general supportive measures including monitoring of vital signs, as well as observation of the clinical status of the patient.
Liječenje predoziranja lijekom Vosevi sastoji se od općih potpornih mjera uključujući praćenje vitalnih znakova kao i promatranje kliničkog stanja bolesnika.
Patients should be instructed not to take a double dose of Vosevi.
Bolesnike treba uputiti da ne uzimaju dvostruku dozu lijeka Vosevi.
Your doctor will test your blood before, during and after your treatment with Vosevi.
Liječnik će Vam napraviti krvne pretrage prije, tijekom i nakon liječenja lijekom Vosevi.
Study arms and duration (Number of patients treated)
Skupine u ispitivanju i trajanje (Broj liječenih bolesnika)
In this limited clinical safety data set, the rate of adverse events and deaths was not clearly elevated from what is expected in ESRD patients.
U tom ograničenom skupu sigurnosnih podataka, stopa štetnih događaja i smrti nije bila očito viša od one kakva se očekuje u bolesnika s ESRD-om.
Voxilaprevi r
Voksilaprevi r
Contents of the pack and other information What Vosevi contains
Sadržaj pakiranja i druge informacije Što sadrži Vosevi
Observed: Elvitegravir ↔ ↔ ↑
Elvitegravir ↔ ↔ ↑
Clinical studies of Vosevi included 189 patients aged 65 and over (17% of total number of patients in the Phase 2 and 3 clinical studies).
Klinička ispitivanja lijeka Vosevi uključila su 189 bolesnika u dobi od 65 godina i više (17 % ukupnog broja bolesnika u kliničkim ispitivanjima faze 2 i 3).
In order to evaluate the recurrence of hepatocellular carcinoma associated with Vosevi, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Kako bi se procijenilo ponovno pojavljivanje hepatocelularnog karcinoma povezanog s primjenom lijeka Vosevi, nositelj odobrenja mora provesti i dostaviti rezultate prospektivnog ispitivanja sigurnosti, koristeći podatake koji proizlaze iz kohorte dobro definirane skupine bolesnika, na temelju dogovorenog protokola.
It is given to adults of 18 years and older to treat a chronic (long-term) viral infection of the liver called hepatitis C.
Daje se odraslima u dobi od 18 i više godina za liječenje kronične (dugotrajne) virusne infekcije jetre koja se naziva hepatitis C.
No patients in the placebo group achieved SVR4.
Nijedan bolesnik u skupini s placebom nije postigao SVR4.
• are taking treatment for human immunodeficiency virus (HIV) infection, since your doctor may want to monitor you more closely.
• ako se liječite protiv infekcije virusom humane imunodeficijencije (HIV), budući da bi Vas liječnik možda htio pažljivije pratiti.
If you are taking an antacid, take it at least 4 hours before or at least 4 hours after Vosevi.
Ako uzimate antacid, uzmite ga najmanje 4 sata prije ili najmanje 4 sata poslije lijeka Vosevi.
These are shown in Table 7.
Prikazane su u tablici 7.
HBV screening should be performed in all patients before initiation of treatment.
Probir na HBV potrebno je provesti u svih bolesnika prije početka liječenja.
• ethinylestradiol containing medicines, including many contraceptives.
• lijekove koji sadrže etinilestradiol, uključujući mnoge kontraceptive.
Use only if no other alternative is available.
Primijeniti samo ako nije dostupno niti jedno zamjensko liječenje.
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Moguće nuspojave Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
These should be taken at least 4 hours before or 4 hours after Vosevi;
Njih treba uzeti najmanje 4 sata prije ili 4 sata poslije lijeka Vosevi;
Lansoprazoled Rabeprazoled Pantoprazoled Esomeprazoled
Lanzoprazold Rabeprazold Pantoprazold Esomeprazold
Skin disorders Frequency not known: Stevens-Johnson syndrome
Nepoznata učestalost: Stevens-Johnsonov sindrom
• rosuvastatin (a medicine used to treat high blood cholesterol or decrease the risk of certain cardiovascular events);
• rosuvastatin (lijek koji se primjenjuje za liječenje visoke razine kolesterola u krvi ili za smanjenje rizika od nekih kardiovaskularnih događaja);
The safety and efficacy of Vosevi in children and adolescents aged less than 18 years have not yet been established.
Sigurnost i djelotvornost lijeka Vosevi u djece i adolescenata u dobi manjoj od 18 godina nisu još ustanovljene.
8 weeks may be considered in genotype 3 infected patients (see section 5.1)
8 tjedana može se razmotriti u bolesnika zaraženih genotipom 3 (vidjeti dio 5.1)
The active substances in this medicine work together by blocking three different proteins that the hepatitis C virus needs to grow and reproduce itself, causing the infection to be eliminated from the body.
Djelatne tvari u ovom lijeku djeluju zajedno tako što blokiraju tri različita proteina koja su virusu hepatitisa C potrebna za rast i umnažanje i time dovode do uklanjanja infekcije iz tijela.
Caution is warranted and therapeutic concentration monitoring of digoxin is recommended.
Potreban je oprez i preporučuje se praćenje terapijskih koncentracija digoksina.
Patients should be instructed to swallow the tablet whole with food (see section 5.2).
Bolesnike treba uputiti da tabletu progutaju cijelu s hranom (vidjeti dio 5.2).
1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.8-fold↑ GS-331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~7-fold↑ 18-fold↑
1,6 puta ↑ 2,1 puta↑ 2,7 puta↑ 1,3 puta↑ 1,6 puta↑ ~2 puta↑ 1,8 puta↑ GS-331007 1,6 puta ↑ 1,9 puta↑ 5,5 puta↑ ≥ 10 puta↑ ≥ 20 puta↑ ~7 puta↑ 18 puta↑ Velpatasvir