natgillin/translations-raw huggingface dataset:
The pharmacokinetics of selexipag and its active metabolite are not affected by warfarin.
Varfarin ne utječe na farmakokinetiku seleksipaga i njegovog aktivnog metabolita.
Uptravi 800 microgram film-coated tablets: Round, green, film-coated tablets with “8” marked on one side.
Uptravi 800 mikrograma filmom obložene tablete: Okrugle, zelene, filmom obložene tablete, s oznakom “8” na jednoj strani.
Uptravi 400 microgram film-coated tablets Round, red, film-coated tablets with “4” debossed on one side.
Uptravi 400 mikrograma filmom obložene tablete Okrugle, crvene, filmom obložene tablete s utisnutim “4” na jednoj strani.
Uptravi 200 microgram film-coated tablets Round, light-yellow, film-coated tablets with “2” debossed on one side.
Uptravi 200 mikrograma filmom obložene tablete Okrugle, svijetlo žute, filmom obložene tablete s utisnutim “2” na jednoj strani.
The most common side effects (may affect more than 1 in 10 people) you may experience while taking Uptravi are:
Najčešće nuspojave (mogu se javiti u više od 1 na 10
Hypromellose, propylene glycol, titanium dioxide (E171), carnauba wax and iron oxides (see below).
Hipromeloza, propilenglikol, titanijev dioksid (E171), karnauba vosak i željezovi oksidi (pogledajte niže).
Uptravi 800 microgram film-coated tablet
Uptravi 800 mikrograma filmom obložena tableta
Uptravi 1,000 microgram film-coated tablets: Round, orange, film-coated tablets with “10” marked on one side.
Uptravi 1000 mikrograma filmom obložene tablete: Okrugle, narančaste, filmom obložene tablete, s oznakom “10” na jednoj strani.
Uptravi 400 microgram film-coated tablets contain iron oxide red (E172).
Uptravi 400 mikrograma filmom obložene tablete sadrže crveni željezov oksid (E172).
Uptravi 1,600 microgram film-coated tablets: Round, brown, film-coated tablets with “16” marked on one side.
Uptravi 1600 mikrograma filmom obložene tablete: Okrugle, smeđe, filmom obložene tablete, s oznakom “16” na jednoj strani.
Uptravi 800 microgram film-coated tablets contain iron oxide yellow and iron oxide black (E172).
Uptravi 800 mikrograma filmom obložene tablete sadrže žuti i crni željezov oksid (E172).
Uptravi 400 microgram film-coated tablets: Round, red, film-coated tablets with “4” marked on one side.
Uptravi 400 mikrograma filmom obložene tablete: Okrugle, crvene, filmom obložene tablete, s oznakom “4” na jednoj strani.
There is no clinical experience with selexipag in patients with severe liver impairment (Child-Pugh class C), therefore Uptravi should not be administered in these patients.
(Child-Pugh stadij C), stoga se Uptravi ne treba primjenjivati u tih bolesnika.
Uptravi 1,400 microgram film-coated tablets: Round, dark-yellow, film-coated tablets with “14” marked on one side.
Uptravi 1400 mikrograma filmom obložene tablete: Okrugle, tamno žute, filmom obložene tablete, s oznakom “14” na jednoj strani.
Uptravi 200 microgram film-coated tablets: Round, light-yellow, film-coated tablets with “2” marked on one side.
Uptravi 200 mikrograma filmom obložene tablete: Okrugle, svijetlo žute, filmom obložene tablete, s oznakom “2” na jednoj strani.
In the Phase 3 placebo-controlled study in patients with PAH, no increased risk of bleeding was detected with selexipag compared to placebo, including when selexipag was administered with anticoagulants (such as heparin, coumarin-type anticoagulants) or inhibitors of platelet aggregation.
U placebom kontroliranom ispitivanju faze 3 u bolesnika s PAH-om nije zabilježen povećan rizik od krvarenja uz seleksipag u usporedbi s placebom,
Uptravi 200 microgram film-coated tablets Each film-coated tablet contains 200 micrograms of selexipag.
Uptravi 200 mikrograma filmom obložene tablete Svaka filmom obložena tableta sadrži 200 mikrograma seleksipaga.
Uptravi 200 microgram film-coated tablets contain iron oxide yellow (E172).
Uptravi 200 mikrograma filmom obložene tablete sadrže žuti željezov oksid (E172).
Selexipag reduced the risk of hospitalisation for PAH as a first outcome event compared to placebo (HR 0.67, 99% CI: 0.46, 0.98; one-sided log-rank p = 0.04).
kao događaja prvog ishoda (HR 0,67; 99% CI: 0,46; 0,98; jednostrana p-vrijednost dobivena log-rank testom = 0,04).
Uptravi 1,400 microgram film-coated tablets contain iron oxide yellow (E172).
Uptravi 1400 mikrograma filmom obložene tablete sadrže žuti željezov oksid (E172).
Uptravi 800 microgram film-coated tablets.
Uptravi 800 mikrograma filmom obložene tablete.
Uptravi 400 microgram film-coated tablets Each film-coated tablet contains 400 micrograms of selexipag.
Uptravi 400 mikrograma filmom obložene tablete Svaka filmom obložena tableta sadrži 400 mikrograma seleksipaga.
Uptravi 600 microgram film-coated tablets: Round, light-violet, film-coated tablets with “6” marked on one side.
Uptravi 600 mikrograma filmom obložene tablete: Okrugle, svijetlo ljubičaste, filmom obložene tablete, s oznakom “6” na jednoj strani.
Uptravi 400 microgram film-coated tablet
Uptravi 400 mikrograma filmom obložena tableta
No accumulation in plasma, either of parent compound or active metabolite, occurred after multiple-dose administration.
Nakon višekratne primjene doze nije bilo nakupljanja ni izvornog oblika lijeka ni aktivnog metabolita u plazmi.
Uptravi 1,200 microgram film-coated tablets: Round, dark-violet, film-coated tablets with “12” marked on one side.
Uptravi 1200 mikrograma filmom obložene tablete: Okrugle, tamno ljubičaste, filmom obložene tablete, s oznakom “12” na jednoj strani.
Uptravi 1,200 microgram film-coated tablets contain iron oxide black and iron oxide red (E172).
Uptravi 1200 mikrograma filmom obložene tablete sadrže crni i crveni željezov oksid (E172).
Uptravi 1,200 microgram film-coated tablet
Uptravi 1200 mikrograma filmom obložena tableta
Uptravi 600 microgram film-coated tablets Each film-coated tablet contains 600 micrograms of selexipag.
Uptravi 600 mikrograma filmom obložene tablete Svaka filmom obložena tableta sadrži 600 mikrograma seleksipaga.
Uptravi 1,000 microgram film-coated tablet
Uptravi 1000 mikrograma filmom obložena tableta
Uptravi 1,200 microgram film-coated tablets Each film-coated tablet contains 1,200 micrograms of selexipag.
Uptravi 1200 mikrograma filmom obložene tablete Svaka filmom obložena tableta sadrži 1200 mikrograma seleksipaga.
Uptravi 1,000 microgram film-coated tablets contain iron oxide red and iron oxide yellow (E172).
Uptravi 1000 mikrograma filmom obložene tablete sadrže crveni i žuti željezov oksid (E172).
Uptravi 600 microgram film-coated tablets contain iron oxide red and iron oxide black (E172).
Uptravi 600 mikrograma filmom obložene tablete sadrže crveni i crni željezov oksid (E172).
Uptravi 200 microgram film-coated tablets.
Uptravi 200 mikrograma filmom obložene tablete.
Uptravi 1,000 microgram film-coated tablets Each film-coated tablet contains 1,000 micrograms of selexipag.
Uptravi 1000 mikrograma filmom obložene tablete Svaka filmom obložena tableta sadrži 1000 mikrograma seleksipaga.
Uptravi 400 microgram film-coated tablets.
Uptravi 400 mikrograma filmom obložene tablete.
Uptravi 1,200 microgram film-coated tablets.
Uptravi 1200 mikrograma filmom obložene tablete.
Uptravi 1,000 microgram film-coated tablets.
Uptravi 1000 mikrograma filmom obložene tablete.
Common side effects (may affect up to 1 in 10 people) - Anaemia (low red blood cell levels) - Hyperthyroidism (overactive thyroid gland) - Decreased appetite - Weight loss - Hypotension (low blood pressure) - Stomach pain - Pain - Changes in some blood test results including those measuring blood cell counts or your thyroid function - Rashes, including hives, may cause a burning or stinging sensation and skin redness
- promjene nalaza testova krvi, uključujući mjerenja broja krvnih stanica ili funkcije štitnjače - osipi, uključujući koprivnjaču, mogu uzrokovati osjećaj pečenja ili bockanja te crvenilo kože
Pain in extremity Vomiting Flushing Arthralgia
bol u ekstremitetima, artralgija i crvenilo uz osjećaj vrućine.
Both in healthy subjects and PAH patients, after oral administration, exposure at steady state to the active metabolite is approximately 3- to 4-fold higher than to the parent compound.
nakon peroralne primjene, izloženost aktivnom metabolitu u stanju dinamičke ravnoteže je približno 3
Uptravi 600 microgram film-coated tablets
Uptravi 600 mikrograma filmom obložena tableta
Uptravi 1,400 microgram film-coated tablet
Uptravi 1400 mikrograma filmom obložena tableta
If you have any side effects, talk to your doctor.
Ako primijetite bilo koju nuspojavu potrebno je obavijestiti liječnika.
• Patient Leaflet.
• Uputu o lijeku.
Uptravi 1,400 microgram film-coated tablets Each film-coated tablet contains 1,400 micrograms of selexipag.
Uptravi 1400 mikrograma filmom obložene tablete Svaka filmom obložena tableta sadrži 1400 mikrograma seleksipaga.
Uptravi 1,600 microgram film-coated tablets contain iron oxide black, iron oxide red and iron oxide yellow (E172).
Uptravi 1600 mikrograma filmom obložene tablete sadrže crni, crveni i žuti željezov oksid (E172).
Uptravi 200 microgram film-coated tablets selexipag
Uptravi 200 mikrograma filmom obložene tablete seleksipag
Musculoskeletal and connective tissue disorders
Poremećaji mišićno koštanog sustava i vezivnog tkiva bol u čeljusti*
Uptravi 200 microgram film-coated tablet
Uptravi 200 mikrograma filmom obložena tableta
Uptravi 600 microgram film-coated tablets.
Uptravi 600 mikrograma filmom obložene tablete.
Uptravi 1,400 microgram film-coated tablets.
Uptravi 1400 mikrograma filmom obložene tablete.
iron oxide red (E172), iron oxide black (E172), carnauba wax.
željezov oksid, žuti (E172), karnauba vosak.
Uptravi 1,600 microgram film-coated tablets Each film-coated tablet contains 1,600 micrograms of selexipag.
Uptravi 1600 mikrograma filmom obložene tablete Svaka filmom obložena tableta sadrži 1600 mikrograma seleksipaga.
In the presence of 400/100 mg lopinavir/ritonavir twice daily, a strong OATP (OATP1B1 and OATP1B3) and P-gp inhibitor, exposure to selexipag increased approximately 2-fold, whereas the exposure to the active metabolite of selexipag did not change.
Pri primjeni 400/100 mg lopinavira/ritonavira, jakog inhibitora OATP (OATP1B1 i OATP1B3) i
Uptravi 1,600 microgram film-coated tablet
Uptravi 1600 mikrograma filmom obložena tableta
Uptravi 1,600 microgram film-coated tablets.
Uptravi 1600 mikrograma filmom obložene tablete.
Clinical efficacy and safety
Klinička djelotvornost i sigurnost Djelotvornost u bolesnika s PAH-om
Hypromellose, propylene glycol, titanium dioxide (E171), iron oxide red (E172), carnauba wax.
Hipromeloza, propilenglikol, titanijev dioksid (E171), željezov oksid, crveni (E172), karnauba vosak.
Uptravi 200 microgram film-coated tablets
Uptravi 200 mikrograma filmom obložene tablete
Hypromellose, propylene glycol, titanium dioxide (E171), iron oxide yellow (E172), carnauba wax.
Hipromeloza, propilenglikol, titanijev dioksid (E171), željezov oksid, žuti (E172), karnauba vosak.
Pain
Dojenje
Hypromellose, propylene glycol, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), carnauba wax.
Hipromeloza, propilenglikol, titanijev dioksid (E171), željezov oksid, crveni (E172), željezov oksid, žuti (E172), karnauba vosak.
Hypromellose, propylene glycol, titanium dioxide (E171), iron oxide black (E172), iron oxide red (E172), carnauba wax.
Hipromeloza, propilenglikol, titanijev dioksid (E171), željezov oksid, crni (E172), željezov oksid, crveni (E172), karnauba vosak.
Hypromellose, propylene glycol, titanium dioxide (E171), iron oxide yellow (E172), iron oxide black (E172), carnauba wax.
Hipromeloza, propilenglikol, titanijev dioksid (E171), željezov oksid, žuti (E172), željezov oksid, crni (E172), karnauba vosak.
Hyperthyroidism Thyroid-stimulating Hormone decreased (see section 4.4)
Endokrini poremećaji hipertireoza smanjena razina hormona koji stimulira štitnjaču
What it is used for?
Za što se koristi?
Date of opening:___________
Datum otvaranja:___________
Date of first authorisation: 26 January 2018
Datum prvog odobrenja: 26. siječnja 2018.
The same recommendations apply, unless specifically indicated.
Primjenjive su iste preporuke, osim ako nije posebno navedeno.
This difference is not clinically relevant.
Ta razlika nije klinički značajna.
ARTEMIS Week 192
ARTEMIS 192. tjedan
On rare occasions, these muscle disorders have been serious.
U rijetkim slučajevima ovi su poremećaji mišića bili ozbiljni.
In some patients additional factor VIII was given.
U nekih je bolesnika primijenjen dodatni faktor VIII.
Interaction studies have only been performed in adults.
Ispitivanja interakcija bila su provedena samo u odraslih.
Examples are: increase in some white blood cells.
Primjer je porast broja nekih bijelih krvnih stanica.
A skin rash might also be a symptom of a rare severe situation.
Osip na koži može biti i simptom rijetkog teškog stanja.
Your doctor will explain these to you.
Vaš će Vam liječnik to pojasniti.
Primary (major) PI mutations
Primarne (velike) PI mutacije
Treatment difference (95% CI of difference)
Razlika liječenja (95% CI razlike)
Several of the interaction studies (indicated by
Nekoliko ispitivanja interakcija (označeno s
Typically, such reactions have been observed within the first weeks or months of initiation of CART.
Takve su reakcije obično zamijećene unutar prvih tjedana ili mjeseci od uvođenja KART-a.
Tell your doctor immediately if you are pregnant, planning to become pregnant or if you are breastfeeding.
Odmah upozorite liječnika ako ste trudni, planirate trudnoću ili ako dojite.
Keep the bottle tightly closed in order to protect from moisture.
Držite bočicu čvrsto zatvorenu radi zaštite od vlage.
Your child's doctor will determine the appropriate dosing regimen for your child.
Liječnik Vašeg djeteta će odrediti prikladni režim doziranja za Vaše dijete.
Overall, the safety profile in these paediatric patients was similar to that observed in the adult population.
Općenito, sigurnosni profil primjene u ovih pedijatrijskih bolesnika bio je sličan onom opaženom u odrasloj populaciji.
Ask your doctor if you are unsure about the severity of your liver disease.
Pitajte svog liječnika ako niste sigurni u težinu bolesti jetre.
LABEL for bottle
NALJEPNICA za bočicu
Infrequently a rash may become severe or potentially life-threatening.
Rijetko, ovaj osip može postati težak ili potencijalno opasan po život.
These interactions are described in the interaction table below.
Ove interakcije su opisane u donjoj tablici interakcija.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
Uvijek uzmite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako Vam je rekao liječnik, ljekarnik ili medicinska sestra.
Your doctor might want to do some additional tests.
Liječnik će možda htjeti učiniti neke dodatne pretrage.
Other corticosteroids: interaction not studied.
Ostali kortikosteroidi: interakcija nije ispitana.
In cases of severe skin reaction see the warning in section 4.4.
U slučajevima teške kožne reakcije vidjeti upozorenje u dijelu 4.4.
Tell your doctor if you take:
Upozorite svog liječnika ako uzimate:
If you notice any of these symptoms please inform your doctor.
Primijetite li bilo koji od ovih simptoma, molimo Vas obavijestite svog liječnika.
Talk to your doctor about the signs and symptoms of liver problems.
Razgovarajte sa svojim liječnikom o znakovima i simptomima tegoba s jetrom.
Regular assessment of virological response is advised.
Preporučuje se redovita procjena virološkog odgovora.
In some cases dosage of other medicines might need to be changed.
U nekim slučajevima možda će biti potrebno promijeniti doziranje drugih lijekova.
The mean treatment duration was 58.4 weeks.
Srednje trajanje liječenja bilo je 58,4 tjedna.
The unbound fraction was also substantially reduced, including around 90% reductions of Cmin levels.
Nevezana frakcija je bila također značajno snižena, uključujući oko 90%-tno smanjenje razina Cmin.
For full information on interactions with other medicinal products see section 4.5.
Za potpune informacije o interakcijama s drugim lijekovima vidjeti dio 4.5.
After day 23 of life, the exposure was comparable to that in adult rats.
Nakon 23. dana života izloženost je usporediva s onom u odraslih štakora.
You must keep in regular contact with your doctor.
Morate se redovito javljati svom liječniku.
It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Vjeruje se da ti simptomi nastaju zbog poboljšanja imunološkog odgovora organizma koje omogućava da se tijelo bori s infekcijama koje su mogle biti prisutne bez vidljivih simptoma.
Therefore always tell your doctor if you take other anti-HIV medicines and follow your doctor's instruction carefully on which medicines can be combined.
Stoga uvijek obavijestite liječnika ako uzimate druge lijekove protiv HIV-a i pažljivo slijedite upute liječnika o tome koji se lijekovi mogu kombinirati.
Clarithromycin (antibiotic)
- klaritromicin (antibiotik)
Darunavir should be discontinued immediately if signs or symptoms of severe skin reactions develop.
Darunavir se mora odmah prestati uzimati ako se razviju znakovi ili simptomi teških kožnih reakcija.
It belongs to a group of medicines called protease inhibitors.
Pripada skupini lijekova nazvanih inhibitori proteaze.
If you have chronic hepatitis B or C infection, your doctor should check your blood tests more often because you have an increased chance of developing liver problems.
Ako imate infekciju kroničnim hepatitisom B ili C, liječnik Vam češće treba provjeravati krvnu sliku, jer imate povećanu mogućnost razvoja tegoba s jetrom.
Tell your healthcare provider about all medicines that you are taking.
Recite svom liječniku za sve lijekove koje uzimate.
With HIV-1 clade Type B
S podtipom HIV-1 Tip B
In the setting of lack or loss of virological response, resistance testing should be performed.
U slučaju nepostojanja ili gubitka virološkog odgovora moraju se provesti pretrage na rezistenciju.
Tell your doctor about your situation BEFORE and DURING your treatment Make sure that you check the following points and tell your doctor if any of these apply to you.
Objasnite liječniku svoje stanje PRIJE i TIJEKOM liječenja Svakako provjerite sljedeće točke i upozorite liječnika odnosi li se neka od njih na Vas.
These effects may be secondary to pup exposure to the active substance via the milk and/or maternal toxicity.
Ti učinci mogu biti sekundarni na izloženost mladunčadi djelatnoj tvari putem mlijeka i/ili materinske toksičnosti.
Analyses of data through 96 weeks of treatment in the POWER trials demonstrated sustained antiretroviral efficacy and immunologic benefit.
Analize podataka liječenja od 96 tjedana u ispitivanjima POWER pokazale su održanu antiretrovirusnu djelotvornost i imunološku korist.
Greater effects may be expected when fluticasone is inhaled.
Veći učinci mogu se očekivati kada se flutikazon inhalira.
This is not a complete list of medicines.
Ovaj popis lijekova nije potpun.
These EC50 values are well below the 50% cellular toxicity concentration range of 87 µM to > 100 µM.
Te vrijednosti EC50 prilično su ispod 50% raspona koncentracija stanične toksičnosti od 87 μM do > 100 µM.
Virologic response was preserved throughout the study period in both arms.
Virološki odgovor je očuvan tijekom trajanja ispitivanja u obje skupine.
Tell your doctor if you have had problems with your liver before, including hepatitis B or C infection.
- Upozorite liječnika ako ste prije imali tegobe s jetrom, uključujući infekciju hepatitisom B ili C.
Frequency categories are defined as follows: 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) and not known (frequency cannot be estimated from the available data).
Kategorije učestalosti definirane su kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
SEDATIVES/HYPNOTICS
SEDATIVI/HIPNOTICI
Cobicistat levels decrease and may not provide sufficient boosting.
Razine kobicistata se smanjuju i možda neće pružiti dovoljno pojačanje.
Shelf life after first opening: 3 months.
Rok valjanosti nakon prvog otvaranja: 3 mjeseca.
Instructions for adults
Upute za odrasle
For storage conditions after first opening of the medicinal product, see section 6.3.
Za uvjete čuvanja nakon prvog otvaranja lijeka vidjeti dio 6.3.
Limited efficacy data are available in paediatric patients below 15 kg and no recommendation on a posology can be made.
Dostupni su ograničeni podaci o djelotvornosti u pedijatrijskih bolesnika ispod 15 kg i nije moguće dati preporuke za doziranje.
Instructions for children
Upute za djecu
The most frequent adverse reactions reported were diarrhoea (28%), nausea (23%), and rash (16%).
Najčešće prijavljene nuspojave bile su proljev (28%), mučnina (23%) i osip (16%).
The exposure levels were lower than those with the recommended clinical dose in humans.
Razine izloženosti su bile niže od onih s klinički preporučenom dozom za ljude.
(MATE1 inhibition)
(MATE1 inhibicija)
Exposure in plasma, liver and brain was considerably higher than in adult rats after comparable doses in mg/kg between days 5 and 11 of age.
Izloženost u plazmi, jetri i mozgu, bila je značajno viša nego u odraslih štakora, nakon usporedivih doza u mg/kg između 5. i 11. dana starosti.
Control n=124
Kontrolna skupina n=124
Due to a decrease in the exposure (AUC) of darunavir by 40%, appropriate doses of the combination have not been established.
Zbog smanjene izloženosti (AUC) darunaviru za 40%, primjerene kombinirane doze nisu ustanovljene.
Tell your doctor immediately if you notice any symptoms of infection (for example enlarged lymph nodes and fever).
- Odmah upozorite liječnika ako uočite bilo kakve simptome infekcije (na primjer, povećane limfne čvorove i vrućicu).
Based upon the findings, the carbamazepine dose may need to be reduced by 25% to 50% in the presence of darunavir/ritonavir.
Na temelju tih nalaza, dozu karbamazepina može biti potrebno smanjiti za 25% do 50% u prisustvu darunavira/ritonavira.
The main cause of these low exposures is a marked reduction in cobicistat exposure as a consequence of pregnancy-associated enzyme induction (see below).
Glavni uzrok ovih niskih izloženosti je znatno smanjenje izloženosti kobicistatu što je posljedica indukcije enzima povezane s trudnoćom (vidjeti niže).
At least 3 oxidative metabolites of darunavir have been identified in humans; all showed activity that was at least 10-fold less than the activity of darunavir against wild type HIV.
Ustanovljena su najmanje 3 oksidativna metabolita darunavira u ljudi; svi su pokazali aktivnost koja je bila najmanje 10 puta manja od aktivnosti darunavira protiv divljeg tipa HIV-a.
Some additional tests might be necessary.
Možda će biti potrebno učiniti neke dodatne pretrage.
800 milligram
800 miligrama
The child must swallow the tablets with a drink such as water or milk.
- Dijete mora progutati tablete s pićem poput vode ili mlijeka.
This cannot be administered with these 600 milligram tablets.
To se ne može primijeniti s ovim tabletama od 600 miligrama.
Swallow the tablets with a drink such as water or milk.
- Progutajte tablete s pićem poput vode ili mlijeka.
In vitro selection of darunavir-resistant virus from wild type HIV-1 was lengthy (> 3 years).
In vitro selekcija virusa rezistentnog na darunavir iz divljeg tipa HIV-1 bila je dugotrajna (> 3 godine).
If prescribed Darunavir Krka twice daily the child must take one dose in the morning, and one dose in the evening.
Ako je Darunavir Krka propisan dvaput na dan dijete mora uzeti jednu dozu ujutro, a jednu dozu navečer.
The safety assessment in paediatric patients is based on the 48-week analysis of safety data from three Phase II trials.
Procjena sigurnosti u pedijatrijskih bolesnika temelji se na 48-tjednoj analizi podataka o sigurnosti dobivenim u tri ispitivanja faze II.
Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake EXP.