FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIAPREZA 2.5 mg/mL sterile concentrate angiotensin II
Slovenian: IME ZDRAVILA IN POT(I) UPORABE GIAPREZA 2,5 mg/ml sterilni koncentrat angiotenzin II
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Samo za enkraten odmerek.
English: La Jolla Pharmaceutical II B.V. Herengracht 500
Slovenian: La Jolla Pharmaceutical II B.V.
English: Stopping GIAPREZA treatment
Slovenian: Prekinitev zdravljenja z zdravilom GIAPREZA
English: Down-titrate by gradual decrements of up to 15 ng/kg per minute, as needed, based on blood pressure in order to avoid hypotension due to abrupt withdrawal (see section 4.4).
Slovenian: Odmerek zmanjšujte po korakih največ 15 ng/kg na minuto, kot je potrebno glede na krvi tlak, da bi se izognili hipotenziji zaradi nenadne ukinitve (glejte poglavje 4.4).
English: Down-titration of therapy, careful observation, and initiation of appropriate supportive measures are the indicated treatment of overdose of angiotensin II.
Slovenian: Indicirano zdravljenje prevelikega odmerjanja angiotenzina II je zmanjšanje odmerka zdravila, skrbno opazovanje in uvedba ustreznih podpornih ukrepov.
English: There are no dose adjustments needed for patients with impairment of the function of the liver or kidneys.
Slovenian: Pri bolnikih z okvarjenim delovanjem jeter ali ledvic prilagajanje odmerka ni potrebno.
English: GIAPREZA response rate
Slovenian: Stopnja odziva pri zdravilu GIAPREZA
English: Sodium
Slovenian: Natrij
English: When initiating GIAPREZA, it is important to closely monitor blood pressure response and adjust dose accordingly.
Slovenian: Ob uvedbi zdravila GIAPREZA je pomembno skrbno spremljati odziv krvnega tlaka in odmerek temu ustrezno prilagoditi.
English: - Angiotensin II receptor blockers (medicines used to lower blood pressure, with active substances whose names usually end in -sartan) may lessen the effect of GIAPREZA.
Slovenian: - zaviralci angiotenzinske konvertaze (ACE - angiotensin converting enzyme) (zdravila, ki se uporabljajo za zniževanje krvnega tlaka, imena njihovih učinkovin pa se običajno končajo napril).
English: As for other patient populations, it is important to closely monitor blood pressure response and adjust dose accordingly.
Slovenian: Enako kot pri drugih populacijah bolnikov je pomembno, da se skrbno spremlja odziv krvnega tlaka in odmerek temu ustrezno prilagodi.
English: ≥ 10 mmHg increase in MAP without an increase in baseline vasopressor therapy at 3 hours.
Slovenian: ≥ 75 mmHg ali povečanje MAP za ≥ 10 mmHg brez povečanja odmerka izhodiščnega vazopresorja.
English: For intravenous use only after dilution.
Slovenian: Samo za intravensko uporabo po redčenju.
English: No in vitro metabolism studies have been performed with GIAPREZA.
Slovenian: Z zdravilom GIAPREZA niso izvedli študij presnove in vitro.
English: The most frequent adverse reactions reported more often in the GIAPREZA arm are thromboembolic events (12.9% vs 5.1%) and transient hypertension.
Slovenian: Najpogostejši neželeni učinki, o katerih so pogosteje poročali v skupini, zdravljeni z zdravilom GIAPREZA, so bili trombembolični dogodki (12,9 % v primerjavi s
English: Patients requiring high doses of steroids, patients with a history of asthma or bronchospasm who were not mechanically ventilated, and patients with Raynaud's syndrome were excluded.
Slovenian: Bolniki, ki so potrebovali velike odmerke steroidov, bolniki z astmo ali bronhospazmom v anamnezi,
English: The major imbalance corresponded to venous thromboembolism (10 [6.1%] vs 0 [0%] respectively).
Slovenian: (10 [6,1 %] v primerjavi z 0 [0 %]).
English: Approximately one in every four patients experienced transient hypertension with the angiotensin II 20 ng/kg per minute starting dose in clinical trials (see section 4.8), thus needing dose down-titration.
Slovenian: Pri približno enem od štirih bolnikov se je v kliničnih preskušanjih ob začetnem odmerku angiotenzina II 20 ng/kg na minuto pojavila prehodna hipertenzija (glejte poglavje 4.8) in so zato potrebovali zmanjšanje odmerka.
English: Approximately one in every four patients experienced transient hypertension with the angiotensin II 20 ng/kg/min starting dose in clinical trials (see section 4.8), thus needing dose downtitration.
Slovenian: Pri približno enem od štirih bolnikov se je v kliničnih preskušanjih ob začetnem odmerku angiotenzina II 20 ng/kg/min pojavila prehodna hipertenzija (glejte poglavje 4.8) in so zato potrebovali zmanjšanje odmerka.
English: 2 ml solution in a Type I glass vial with an aluminium over-seal, stopper (elastomeric), and plastic cap.
Slovenian: 2 ml raztopine v viali iz stekla tipa I z aluminijasto zapiralno obrobo, (elastomerno) zaporko in plastičnim pokrovčkom.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: Concurrent venous thromboembolism prophylaxis (VTE) should be used unless contraindicated during treatment with GIAPREZA.
Slovenian: Med zdravljenjem z zdravilom GIAPREZA je treba sočasno uporabljati profilakso za venske trombembolije (VTE), razen če je kontraindicirana.
English: Posology and method of administration
Slovenian: Odmerjanje in način uporabe
English: Peripheral ischaemia a Grouped term to include arterial and venous thrombotic events b Defined as an increase in mean arterial pressure > 100 mmHg
Slovenian: b Opredeljeno kot povečanje povprečnega arterijskega tlaka za > 100 mmHg
English: As for other age groups, it is important to closely monitor blood pressure response and adjust dose accordingly.
Slovenian: Enako kot pri drugih starostnih skupinah je pomembno, da se skrbno spremlja odziv krvnega tlaka in odmerek temu ustrezno prilagodi.
English: Infusion bag size (mL)
Slovenian: Velikost infuzijske vrečke
English: NAME OF THE MEDICINAL PRODUCT GIAPREZA 2.5 mg/ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA GIAPREZA 2,5 mg/ml koncentrat za raztopino za infundiranje
English: Intravenous use only after dilution.
Slovenian: Samo intravenska uporaba po redčenju.
English: Vascular disorders
Slovenian: Razredčena raztopina
English: How GIAPREZA is used
Slovenian: Kako uporabljati zdravilo GIAPREZA
English: vasodilatory shock and associated severe acute kidney injury requiring renal replacement therapy to provide: (1) data on the effect of the product on morbidity events and organ perfusion with and adequate representation of European patients, (2) reassurance that there is no detrimental effect on mortality at day 28, (3) additional safety data about ischemic and thromboembolic events associated with the use of the product and to record clinical global impression of the response to treatment.
Slovenian: Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): Za nadaljnjo preučitev učinkovitosti in varnosti zdravila Giapreza pri zdravljenju neodzivne hipotenzije pri odraslih s septičnim ali drugačnim distribucijskim šokom mora imetnik dovoljenja za promet z zdravilom izvesti randomizirano, dvojno slepo, s placebom nadzorovano multicentrično študijo pri odraslih bolnikih z vazodilatatornim šokom in povezano hudo akutno poškodbo ledvic, zaradi katere je potrebno ledvično nadomestno zdravljenje, in predložiti njene rezultate ter s tem zagotoviti: (1) podatke o učinku zdravila na obolevnost in perfuzijo organov z ustrezno zastopanostjo evropskih bolnikov, (2) jamstvo, da do 28. dneva ne pride do negativnega učinka na smrtnost, (3)
English: GIAPREZA 2.5 mg/ml concentrate for solution for infusion angiotensin II
Slovenian: GIAPREZA 2,5 mg/ml koncentrat za raztopino za infundiranje angiotenzin II
English: One vial of 2 ml concentrate for solution for infusion contains 5 mg of angiotensin II.
Slovenian: Ena viala z 2 ml koncentrata za raztopino za infundiranje vsebuje 5 mg angiotenzina II.
English: Tachycardia
Slovenian: GIAPREZA.
English: Pregnancy, breast-feeding and fertility
Slovenian: terlipresinom, dopaminom in/ali fenilefrinom.
English: Do not exceed 80 ng/kg per minute during the first 3 hours of treatment.
Slovenian: V prvih treh urah zdravljenja se ne sme preseči odmerka 80 ng/kg na minuto.
English: One vial of 1 ml concentrate for solution for infusion contains 2.5 mg of angiotensin II.
Slovenian: Ena viala z 1 ml koncentrata za raztopino za infundiranje vsebuje 2,5 mg angiotenzina II.
English: Instructions for dilution
Slovenian: Navodila za redčenje
English: Each ml contains angiotensin II acetate equivalent to 2.5 mg angiotensin II.
Slovenian: En ml vsebuje angiotenzin II acetat v količini, ki ustreza 2,5 mg angiotenzina II.
English: 1 ml solution in a Type I glass vial with an aluminium over-seal, stopper (elastomeric), and plastic cap.
Slovenian: 6.5 Vrsta ovojnine in vsebina En ml raztopine v viali iz stekla tipa I z aluminijasto zapiralno obrobo, (elastomerno) zaporko in plastičnim pokrovčkom.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 2.5 mg of angiotensin II (as acetate)
Slovenian: En ml vsebuje 2,5 mg angiotenzina II (v obliki acetata).
English: Baseline MAP < 65 mmHg 10/50 patients
Slovenian: < 65 mmHg
English: One or two millilitres of GIAPREZA must be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection to achieve a final concentration of 5,000 ng/mL or 10,000 ng/mL (see Table 1).
Slovenian: Za doseganje končne koncentracije 5.000 ng/ml ali 10.000 ng/ml morate en ali dva mililitra zdravila GIAPREZA razredčiti v raztopini natrijevega klorida 9 mg/ml (0,9%) za injiciranje (glejte preglednico 1).
English: Tell your doctor immediately if you experience: - Pain, redness or pale colour, swelling or coolness to the touch of the skin or limbs, as these may be symptoms of a blood clot in one of your veins.
Slovenian: - bolečino, pordelost ali bledico, otekanje, kožo ali okončine, hladne na dotik, saj so to lahko simptomi krvnega strdka v eni od ven. Ti strdki lahko potujejo po krvnih žilah v pljuča ter povzročijo bolečino v prsnem košu in težave z dihanjem.
English: Marketing Authorisation Holder La Jolla Pharmaceutical II B.V. Herengracht 500
Slovenian: Imetnik dovoljenja za promet z zdravilom La Jolla Pharmaceutical II B.V.
English: Your doctor will gradually decrease the amount of GIAPREZA you are given over time once your blood pressure has increased to appropriate levels.
Slovenian: Ko se bo vaš krvni tlak zvišal na ustrezno raven, bo zdravnik postopoma zmanjševal odmerek zdravila
English: Pharmacotherapeutic group: Cardiac therapy, other cardiac stimulants, ATC code: C01CX09
Slovenian: 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: zdravila za bolezni srca, drugi spodbujevalci srčne funkcije, oznaka
English: Renal or hepatic impairment
Slovenian: Okvara jeter ali ledvic
English: Discard unused portions.
Slovenian: Neuporabljeni del zavrzite.
English: Administer as a diluted solution.
Slovenian: Dajajte v obliki razredčene raztopine.
English: Unopened vial
Slovenian: OVOJNINAH VIALA
English: More patients experienced peripheral ischaemia in the GIAPREZA arm compared to the placebo arm (7 [4.3%] vs 4 [2.5%]).
Slovenian: (7 [4,3 %]) kot v skupini, ki je prejemala placebo (4 [2,5 %]).
English: The primary endpoint was the percentage of subjects who achieved either a MAP ≥ 75 mmHg or a
Slovenian: Primarni opazovani dogodek je bil odstotek preiskovancev, ki so po treh urah dosegli MAP
English: What GIAPREZA contains - The active substance is angiotensin II acetate.
Slovenian: - Učinkovina je angiotenzin II (v obliki acetata).
English: EXP: After dilution, use immediately.
Slovenian: Po redčenju uporabite takoj.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains angiotensin II acetate equivalent to 2.5 mg angiotensin II.
Slovenian: En ml koncentrata vsebuje angiotenzin II acetat v količini, ki ustreza 2,5 mg angiotenzina II.
English: NAME OF THE MEDICINAL PRODUCT GIAPREZA 2.5 mg/ml concentrate for solution for infusion angiotensin II
Slovenian: Navodilo za uporabo GIAPREZA 2,5 mg/ml koncentrat za raztopino za infundiranje angiotenzin II
English: The median dose of GIAPREZA was 10 ng/kg/min at 30 minutes.
Slovenian: 30 minutah je bil 10 ng/kg/min.
English: 6.3 Shelf life
Slovenian: 6.3 Rok uporabnosti Neodprta viala
English: Two (1.2%) patients in the GIAPREZA arm experienced a fatal thromboembolic event compared with no patients in the placebo arm. Concurrent venous thromboembolism prophylaxis should be used unless contraindicated during treatment with GIAPREZA (see section 4.4).
Slovenian: Med zdravljenjem z zdravilom GIAPREZA je treba sočasno uporabljati profilakso za vensko trombembolijo, razen če je kontraindicirana (glejte poglavje 4.4).
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (IZDELOVALCI), ODGOVOREN
English: Posology
Slovenian: Dajanje
English: Withdraw amount (mL)
Slovenian: (ml)
English: Thromboembolic eventsa Transient hypertensionb
Slovenian: Mediani odmerek zdravila GIAPREZA po
English: Elderly
Slovenian: SERIJ
English: Do not use if you notice any signs of visible damage or discolouration.
Slovenian: Zdravila ne uporabljajte, če opazite znake vidne poškodbe ali obarvanje.
English: Preparation of diluted solution
Slovenian: Preglednica 1: Priprava razredčene raztopine
English: The type of food is not important.
Slovenian: Vrsta hrane ni pomembna.
English: It is important that both men and women read the information.
Slovenian: Pomembno je, da informacije preberejo tako moški kot ženske.
English: This is so that your doctor can:
Slovenian: To pa zato, da lahko zdravnik:
English: The final study report shall be submitted by:
Slovenian: Končno poročilo o študiji mora biti predloženo do:
English: Ask your doctor about the best contraception for you.
Slovenian: Vprašajte svojega zdravnika za najboljšo kontracepcijo za vas.
English: It is very important that you complete the full course of treatment.
Slovenian: Zelo pomembno je, da v celoti zaključite postopek zdravljenja.
English: AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Slovenian: Ελλάδα AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
English: Frequency not known: cannot be estimated based on available data
Slovenian: Neznana pogostnost: ne more biti ocenjena na podlagi razpoložljivih podatkov
English: This is not an exclusive list.
Slovenian: To ni izčrpen seznam.
English: Date of first authorisation: 15 January 2015 Date of latest renewal:
Slovenian: Datum prve odobritve: 15.01.2015 Datum zadnjega podaljšanja:
English: Use with caution.
Slovenian: Uporabljajte previdno.
English: - Your urine is darker than normal.
Slovenian: − je vaš urin temnejši kot običajno;
English: Your doctor will tell you how long your treatment will last.
Slovenian: Zdravnik vam bo povedal, kako dolgo bo trajalo zdravljenje.
English: Number of Responders at the End of Treatment
Slovenian: Število odzivnih na koncu zdravljenja
English: • The other ingredients are:
Slovenian: • Druge sestavine zdravila so:
English: Main characteristics are shown below.
Slovenian: Glavne značilnosti so prikazane spodaj.
English: Patients should be instructed not to take a double dose.
Slovenian: Bolnikom je treba naročiti, da ne smejo vzeti dvojnega odmerka.
English: Also see section 4.6.
Slovenian: Glejte tudi poglavje 4.6.
English: The doctor may need to change your dose of these medicines.
Slovenian: Zdravnik bo morda moral spremeniti odmerek teh zdravil.
English: EFFECT Cmax
Slovenian: UČINEK Cmax
English: 3 years
Slovenian: 3 leti
English: Effects of food
Slovenian: Vpliv hrane
English: Keep the medicine pack with you so you can easily describe what you have taken.
Slovenian: Škatlo z zdravilom vzemite s seboj, tako da boste lahko opisali, kaj ste zaužili.
English: This medicine is available without a prescription
Slovenian: To zdravilo je na voljo brez recepta.
English: Efficacy analyses performed on other parts of the study demonstrated similarly high SVR12 rates.
Slovenian: Analize učinkovitosti izvedene na drugih delih študije, so pokazale podobno visoke deleže SVR12.
English: e. Observed in combination in 6% (4/67) of the subjects.
Slovenian: e. Opaženo v kombinaciji pri 6 % (4/67) preiskovancev.
English: You will take Exviera for 8, 12 or 24 weeks.
Slovenian: Zdravilo Exviera boste jemali 8, 12 ali 24 tednov.
English: Two subjects received a blood transfusion.
Slovenian: Dva preiskovanca sta prejela transfuzijo krvi.
English: How much to take
Slovenian: Koliko jemati
English: In cell culture
Slovenian: V celični kulturi
English: • You or your partner must use an effective method of contraception during treatment.
Slovenian: • Vi ali vaš partner morate med zdravljenjem uporabljati učinkovito metodo kontracepcije.
English: Depression or psychiatric illness
Slovenian: Depresija ali psihiatrične bolezni
English: Laboratory parameters
Slovenian: Laboratorijski parametri
English: If you do miss a dose and it is:
Slovenian: Če ste pozabili vzeti odmerek in če je:
English: • Worsening liver problems.
Slovenian: • Poslabšanje težav z jetri.
English: Ribavirin stays for a long time in the body after treatment is stopped, and effective contraception is therefore needed both during treatment and for some time afterwards.
Slovenian: Ribavirin ostane v telesu dolgo časa po prenehanju zdravljenja in učinkovita kontracepcija je zato potrebna tako med zdravljenjem kot tudi še nekaj časa po tem.
English: See also Section 4.8 for discussion of safety information for RUBY-I.
Slovenian: Glejte tudi poglavje 4.8 glede razlage o varnostnih podatkih za RUBY-I.
English: • If you are allergic to dasabuvir or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • Če ste alergični na dasabuvir ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: How to take
Slovenian: Kako jemati
English: Pregnancy and contraception
Slovenian: Nosečnost in kontracepcija
English: 67061 Ludwigshafen GERMANY
Slovenian: 67061 Ludwigshafen
English: Race or ethnicity
Slovenian: Rasa ali etnična pripadnost
English: Persistence of resistance-associated substitutions
Slovenian: Trajnost z odpornostjo povezanih substitucij
English: • If you are taking any of the medicines listed in the following table.
Slovenian: • Če jemljete katero koli od zdravil, navedenih v preglednici v nadaljevanju.
English: • Do not chew, crush or break the tablets as they may have a bitter taste.
Slovenian: • Tablet ne žvečite, drobite ali lomite, ker imajo lahko grenak okus.
English: ANTIBIOTICS (SYSTEMIC ADMINISTRATION)
Slovenian: ANTIBIOTIKI (SISTEMSKA UPORABA)
English: • Decide what other medicines you should take with Exviera and for how long.
Slovenian: • odloči, katera druga zdravila morate jemati z zdravilom Exviera in kako dolgo;
English: The effects of Exviera during pregnancy are not known.
Slovenian: Učinki zdravila Exviera med nosečnostjo niso znani.
English: Therefore, the interaction profile of the compounds must be considered as a combination.
Slovenian: Zato je treba interakcijske značilnosti spojin upoštevati za kombinacijo.
English: 12 weeks
Slovenian: 12 tednov
English: 60 patients were randomized and treated, and 60/60 (100%) achieved SVR12.
Slovenian: 60 bolnikov je bilo randomiziranih in zdravljenih in 60/60 (100 %) jih je doseglo SRV12.
English: Table 16 shows SVR rates for these subjects.
Slovenian: Preglednica 16 prikazuje deleže SVR za te preiskovance.
English: - Notice yellowing of your skin or eyes.
Slovenian: − opazite porumenelost kože ali oči;
English: Dasabuvir has no or negligible influence on the ability to drive and use machines.
Slovenian: Dasabuvir nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Do not take Exviera if any of the above apply to you.
Slovenian: Ne jemljite zdravila Exviera, če kar koli od zgoraj navedenega velja za vas.
English: • Feeling very tired (fatigue)
Slovenian: • občutek hude utrujenosti (utrujenost)
English: • If you or your partner becomes pregnant during treatment with Exviera and ribavirin or in the months that follow, you must contact your doctor immediately.
Slovenian: • Če vi ali vaša partnerica zanosi med zdravljenjem z zdravilom Exviera in ribavirinom ali v naslednjih mesecih po zdravljenju, takoj obvestite svojega zdravnika.
English: No adverse effects on behaviour, reproduction or development of offspring were reported.
Slovenian: Neželenih učinkov na vedenje, reprodukcijo ali razvoj potomstva niso zabeležili.
English: Hepatitis B virus reactivation
Slovenian: Reaktivacija virusa hepatitisa B
English: Early discontinuation may result in drug resistance, but implications for future therapy are not known.
Slovenian: Predčasna prekinitev lahko povzroči odpornost proti zdravilu, a posledice za zdravljenje v prihodnje niso znane.
English: (see also Table 2).
Slovenian: (glejte preglednico 2).
English: Patients should be instructed to swallow the tablets whole (i.e. patients should not chew, break or dissolve the tablet).
Slovenian: Bolnikom je treba naročiti, naj tablete pogoltnejo cele (tj. tablet ne smejo zgristi, prelomiti ali raztopiti).
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah,
English: *Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot.
Slovenian: za redčenje krvi *Vaš zdravnik bo morda moral povečati pogostnost vaših krvnih preiskav, da preveri sposobnost strjevanja vaše krvi.
English: Sirolimus blood concentrations should be monitored every 4 to 7 days until 3 consecutive trough levels have shown stable concentrations of sirolimus.
Slovenian: Koncentracije sirolimusa v krvi je potrebno spremljati vsake 4 do 7 dni, dokler 3 zaporedne najnižje koncentracije ne pokažejo stabilne koncentracije sirolimusa.
English: • Take the tablets with food.
Slovenian: • Tablete vzemite s hrano.
English: • Trouble sleeping (insomnia)
Slovenian: • srbenje • težave s spanjem (insomnija)
English: 95% CIa F0-F1
Slovenian: 95 % IZa F0-F1
English: The use of Exviera in children and adolescents has not yet been studied.
Slovenian: Uporaba zdravila Exviera pri otrocih in mladostnikih še ni bila raziskana.
English: • Swelling of the layers of skin which can affect any part of the body including the face, tongue or throat and may cause difficulty swallowing or breathing (angioedema)
Slovenian: • Otekanje plasti kože, ki lahko prizadane katerikoli del telesa, vključno z obrazom, jezikom ali grlom, in lahko povzroči oteženo požiranje ali dihanje (angioedem).
English: Ribavirin may cause severe birth defects.
Slovenian: Ribavirin lahko povzroči resne prirojene okvare.
English: See sections 4.8 and 5.1 for additional information.
Slovenian: Za dodatne informacije glejte poglavji 4.8 in 5.1.
English: This regimen can be used in the absence of extensive PI resistance (i.e. lack of darunavir associated RAMs), see also section 4.4.
Slovenian: To shemo je mogoče uporabiti, če ni obsežne odpornosti proti PI (tj. odsotnost RAM, povezanih z darunavirjem), glejte tudi poglavje 4.4
English: Most patients with these severe outcomes had evidence of advanced or decompensated cirrhosis prior to initiating therapy.
Slovenian: Pri večini bolnikov s temi hudimi izidi je bila pred začetkom terapije dokazana napredovala ali dekompenzirana ciroza.
English: • More than 6 hours until your next dose - take the missed dose with food as soon as possible.
Slovenian: • več kot 6 ur do naslednjega odmerka - vzemite pozabljeni odmerek s hrano v najkrajšem možnem času;
English: - have diabetes.
Slovenian: - imate sladkorno bolezen.
English: Exviera tablets do not work on their own.
Slovenian: Tablete zdravila Exviera ne delujejo samostojno.
English: For patients with cirrhosis:
Slovenian: Za bolnike s cirozo: