FrancophonIA/ELRC3.0 huggingface dataset:
English: How has Caspofungin Accord been studied?
Slovenian: Kako je bilo zdravilo Caspofungin Accord raziskano?
English: No additional studies in humans were needed as Caspofungin Accord is a generic medicine that is given by infusion and contains the same active substance as Cancidas.
Slovenian: Ker je zdravilo Caspofungin Accord generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot zdravilo Cancidas, niso bile potrebne nobene dodatne študije pri ljudeh.
English: How does Caspofungin Accord work?
Slovenian: Kako zdravilo Caspofungin Accord deluje?
English: How is Caspofungin Accord used?
Slovenian: Kako se zdravilo Caspofungin Accord uporablja?
English: l t o r
Slovenian: Jakos t
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmith Kline
Slovenian: Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals
English: 2.5 ml (suspension) 2.5 ml (emulsion)
Slovenian: 2,5 ml (suspenzija) 2,5 ml (emulzija)
English: Intramuscular use suspension (H5N1): vial (glass) emulsion (adjuvant): vial (glass)
Slovenian: Intramuskularna uporaba suspenzija (H5N1): viala (steklo) emulzija (adjuvans): viala (steklo)
English: 3.75 µg HA Suspension and Emulsion for emulsion for injection
Slovenian: Suspenzija in emulzija za emulzijo za injiciranje
English: This is of particular concern, as these patients and patients with renal impaired are already particularly prone to developing hyperkalaemia.
Slovenian: To je zlasti zaskrbljujoče, saj so ti bolniki in bolniki z ledvično okvaro še posebej nagnjeni k razvoju hiperkaliemije.
English: RAS-acting agents include angiotensinconverting enzyme inhibitors (ACE-inhibitors) such as benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril and zofenopril), angiotensin receptor blockers (ARBs) such as candesartan, telmisartan, valsartan, irbesartan, eprosartan, olmesartan, losartan and azilsartan and direct renin inhibitors such as aliskiren.
Slovenian: Med snovi, ki delujejo na renin-angiotenzinski sistem, spadajo zaviralci angiotenzin konvertirajočega encima (zaviralci ACE), kot so benazepril, kaptopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moeksipril, perindopril, kvinapril, ramipril, spirapril, trandolapril in zofenopril, zaviralci angiotenzinskih receptorjev (ARB-ji), kot so kandesartan, telmisartan, valsartan, irbesartan, eprosartan, olmesartan, losartan in azilsartan, in neposredni zaviralci renina, kot je aliskiren.
English: In addition, the metaanalysis suggested that using multiple RAS-acting agents may not be more beneficial than using a single RAS-acting agent in terms of reducing overall mortality.
Slovenian: Poleg tega je metaanaliza pokazala, da uporaba več snovi, ki delujejo na reninangiotenzinski sistem, morda ni koristnejša od uporabe ene snovi, ki deluje na renin-angiotenzinski sistem, kar zadeva zmanjšanje celokupne smrtnosti.
English: Having considered the new available evidence from the scientific literature and given the seriousness of the identified safety concerns, the Italian Medicines Agency (AIFA) decided to initiate a review under Article 31 of Council Directive 2001/83/EC on 17 April 2013, referring the matter to the Pharmacovigilance Risk Assessment Committee (PRAC) and requesting the PRAC to issue a recommendation on the benefit-risk of dual RAS blockade therapy through the combined use of ACE-inhibitors, ARBs or aliskiren and whether any regulatory measures should be taken on the marketing authorisations of the products involved in this procedure.
Slovenian: Po preučitvi novih razpoložljivih dokazov iz znanstvene literature in glede na resnost ugotovljenih zadržkov v zvezi z varnostjo je italijanska agencija za zdravila (AIFA) 17. aprila 2013 sprožila pregled v skladu s členom 31 Direktive Sveta 2001/83/ES in zadevo napotila na Odbor za oceno tveganja na področju farmakovigilance (PRAC) ter od njega zahtevala, da izda priporočilo o razmerju med tveganji in koristmi zdravljenja z dvojnim zaviranjem renin-angiotenzinskega sistema s kombinirano uporabo zaviralcev ACE, zaviralcev angiotenzinskih receptorjev ali aliskirena in navede, ali bi bilo treba sprejeti kakršne koli regulativne ukrepe za dovoljenja za promet z zdravili, ki so predmet tega postopka.
English: In particular, a number of trials in heart failure patients have shown that the addition of a second RAS-acting agent may reduce hospital admissions for heart failure in patients with heart failure, which is considered a meaningful clinical endpoint.
Slovenian: Zlasti številna preskušanja pri bolnikih s srčnim popuščanjem so pokazala, da lahko dodatek druge snovi, ki deluje na renin-angiotenzinski sistem, zmanjša število sprejemov v bolnišnico zaradi srčnega popuščanja pri bolnikih s srčnim popuščanjem, kar velja za pomembno klinično končno točko.
English: The PRAC was also of the opinion that the contraindication based on the ALTITUDE5 study data regarding the concomitant use of ACEinhibitors or ARBs with aliskiren-containing products in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m2) was confirmed by the additional data reviewed and that it should also be implemented in the product information of ARBs and ACE-inhibitors.
Slovenian: Prav tako je menil, da dodatni pregledani podatki potrjujejo kontraindikacijo na podlagi podatkov iz študije ALTITUDE5 glede sočasne uporabe zaviralcev ACE ali zaviralcev angiotenzinskih receptorjev z zdravili, ki vsebujejo aliskiren, pri bolnikih s sladkorno boleznijo ali ledvično okvaro (stopnja glomerularne filtracije < 60 ml/min/1,73 m2) in da je treba to kontraindikacijo prav tako vključiti v informacije o zdravilu za zaviralce angiotenzinskih receptorjev in zaviralce ACE.
English: For candesartan- and valsartan-containing products, which are also authorised in the treatment of heart failure, additional information was agreed upon to reflect the fact that dual RAS blockade therapy in combination with an ACE-inhibitor may be of benefit in certain patients who cannot use other heart failure treatments, provided that they are used under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Slovenian: Za zdravila, ki vsebujejo kandesartan in valsartan, ki so prav tako odobrena za zdravljenje srčnega popuščanja, so sprejeli dodatne informacije, ki odražajo, da je lahko zdravljenje z dvojno blokado renin-angiotenzinskega sistema v kombinaciji z zaviralci ACE koristno pri določenih bolnikih, pri katerih ni mogoče uporabiti drugih vrst zdravljenja za srčno popuščanje, če so pod nadzorom zdravnika specialista in se pri njih pogosto skrbno spremlja delovanje ledvic, vrednosti elektrolitov in krvni tlak.
English: Annex I Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Slovenian: Znanstveni zaključki, podlaga za spremembo pogojev dovoljenj za promet z zdravilom ter podrobna obrazložitev znanstvenih razlogov za odstopanja od priporočila odbora PRAC
English: The PRAC reviewed the totality of the available data, including clinical trials, meta-analysis and publications, the MAHs' responses as well as the report from the Scientific Advisory Group in Cardiovascular Issues (SAG CVS).
Slovenian: Odbor PRAC je pregledal vse razpoložljive podatke, vključno s kliničnimi preskušanji, metaanalizami in publikacijami, odgovori imetnikov dovoljenj za promet z zdravili ter poročilom znanstveno svetovalne
English: The PRAC was of the opinion that there is considerable evidence from large clinical trials and meta-analyses which conclusively demonstrates that dual RAS blockade therapy through the combined use of ACE-inhibitors, ARBs or aliskiren is associated with an increased risk of adverse events, including hypotension, hyperkalaemia and
Slovenian: Menil je, da obstaja veliko dokazov iz obsežnih kliničnih preskušanj in metaanaliz, ki jasno kažejo, da je zdravljenje z dvojnim zaviranjem reninangiotenzinskega sistema s kombinirano uporabo zaviralcev ACE, zaviralcev angiotenzinskih receptorjev ali aliskirena povezano s povečanim tveganjem za neželene učinke, vključno s hipotenzijo, hiperkaliemijo in ledvično odpovedjo, v primerjavi z monoterapijo, zlasti pri bolnikih z diabetično nefropatijo.
English: In particular, the publication of a metaanalysis by Makani et al1 involving over 68,000 patients raised concerns that combining several RAS-acting agents may be associated with an increased risk of hyperkalaemia, hypotension and kidney failure, compared with the single use of one RAS-acting agent.
Slovenian: Zadržki, da je lahko kombinacija več snovi, ki delujejo na renin-angiotenzinski sistem, povezana s povečanim tveganjem za hiperkaliemijo, hipotenzijo in ledvično odpovedjo v primerjavi z uporabo samo ene snovi, ki deluje na renin-angiotenzinski sistem, so se pojavili predvsem zaradi objave metaanalize, ki so jo izvedli Makani in sod.1 in je vključevala več kot 68 000 bolnikov.
English: Date of first authorisation: 12 February 2007 Date of latest renewal: 19 September 2013
Slovenian: Datum prve pridobitve dovoljenja za promet: 12. februar 2007 Datum zadnjega podaljšanja dovoljenja za promet: 19. september 2013
English: Type AE
Slovenian: Tip AE
English: On rare occasions, these muscle disorders have been serious.
Slovenian: V redkih primerih so bile te mišične težave resne,
English: What PREZISTA is and what it is used for
Slovenian: Kaj je zdravilo PREZISTA in za kaj ga uporabljamo
English: These are mentioned above under the heading ‘Do not combine PREZISTA with any of the following medicines:'
Slovenian: Navedena so zgoraj pod naslovom ‘Zdravila PREZISTA ne smete kombinirati z nobenim od naslednjih zdravil:'.
English: The requirements for submission of periodic safety update reports 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 rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in v vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Treatment difference (95% CI of difference)
Slovenian: Razlika v zdravljenju (95% IZ razlike)
English: Tell your doctor immediately if you are pregnant, planning to become pregnant or if you are breast-feeding.
Slovenian: Takoj obvestite zdravnika, če ste noseči, načrtujete nosečnost ali če dojite.
English: PREZISTA works by reducing the amount of HIV in your body.
Slovenian: PREZISTA deluje tako, da zmanjša količino HIV v telesu.
English: HIV PI darunavir amprenavir atazanavir indinavir lopinavir saquinavir tipranavir
Slovenian: HIV PI darunavir amprenavir atazanavir indinavir lopinavir sakvinavir tipranavir
English: This ingredient may cause allergic reactions (sometimes delayed).
Slovenian: Ta pomožna snov lahko povzroči alergijsko reakcijo (včasih zapoznelo).
English: PREZISTA with food and drink See section 3 ‘How to take PREZISTA.'
Slovenian: Zdravilo PREZISTA skupaj s hrano in pijačo Glejte poglavje 3 «Kako jemati zdravilo PREZISTA«.
English: Type C
Slovenian: Tip C ostali
English: There are some medicines that you must not combine with PREZISTA.
Slovenian: Obstajajo določena zdravila, ki jih ne smete kombinirati z zdravilom PREZISTA.
English: The effects of PREZISTA might be reduced if you take any of the following products.
Slovenian: Učinki zdravila PREZISTA so lahko zmanjšani, če jemljete katerega od naslednjih zdravil.
English: Avoid exposure to excessive heat.
Slovenian: Ne izpostavljajte čezmerni toploti.
English: If you forget to take PREZISTA
Slovenian: Če ste pozabili vzeti zdravilo PREZISTA
English: 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).
Slovenian: Kategorije pogostnosti so opredeljene kot sledi: zelo pogosti ( 1/10), pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1.000, < 1/100), redki (≥ 1/10.000 do < 1/1.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: PREZISTA has only been used in limited numbers of patients 65 years or older.
Slovenian: Zdravilo PREZISTA je bilo uporabljeno le pri majhnem številu bolnikov starih 65 let ali več.
English: R(-) methadone AUC ↓ 16% R(-) methadone Cmin ↓ 15% R(-) methadone Cmax ↓ 24%
Slovenian: R(-) metadon AUC ↓ 16% R(-) metadon Cmin ↓ 15% R(-) metadon Cmax ↓ 24%
English: These EC50 values are well below the 50% cellular toxicity concentration range of 87 µM to > 100 µM.
Slovenian: Te vrednosti EC50 so precej nižje od 50% razpona koncentracij, ki so toksične za celice - od 87 µM do > 100 µM.
English: In an interaction study
Slovenian: V študiji medsebojnih delovanj
English: Your doctor should do blood tests before you start PREZISTA.
Slovenian: Zdravnik bo opravil krvne preiskave, preden začnete jemati zdravilo PREZISTA.
English: darunavir AUC24h ↑ 33% (based on population pharmacokinetic model)
Slovenian: ↑ AUC24h darunavirja za 33% (na osnovi populacijskega farmakokinetičnega modela)
English: People taking PREZISTA may still develop infections or other illnesses associated with HIV infection.
Slovenian: Pri osebah, ki jemljejo zdravilo PREZISTA, se lahko še vedno pojavijo okužbe ali druge bolezni, ki so povezane z okužbo s HIV.
English: The most frequent adverse reactions reported were diarrhoea (28%), nausea (23%), and rash (16%).
Slovenian: Najpogosteje poročani neželeni učinki so bili diareja (28%), navzea (23%) in izpuščaj (16%).
English: Oral suspension
Slovenian: peroralna suspenzija
English: If you belong to this age group, please discuss with your doctor if you can use PREZISTA.
Slovenian: Če sodite v to starostno skupino, se s svojim zdravnikom pogovorite, ali lahko uporabljate zdravilo PREZISTA.
English: Several of the interaction studies (indicated by
Slovenian: Številne interakcijske študije (označene z
English: Very common side effects (may affect more than 1 in 10 people) - diarrhoea.
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) - driska
English: based upon non dose normalised values
Slovenian: na osnovi vrednosti, ki niso bile normalizirane z odmerkom
English: darunavir amprenavir atazanavir indinavir lopinavir saquinavir tipranavir
Slovenian: darunavir amprenavir atazanavir indinavir lopinavir sakvinavir tipranavir
English: Treatment of overdose with PREZISTA consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Slovenian: Zdravljenje prevelikega odmerjanja zdravila PREZISTA sestoji iz splošnih podpornih ukrepov, vključno s spremljanjem vitalnih znakov in opazovanjem kliničnega stanja bolnika.
English: What is PREZISTA?
Slovenian: Kaj je zdravilo PREZISTA?
English: Out of the 59 patients who responded with complete viral suppression (< 50 copies/ml) at week 48, 47 patients (80% of the responders at week 48) remained responders at week 96.
Slovenian: Med 59 bolniki, ki so odgovorili s popolno virusno supresijo (< 50 kopij/ml) v 48. tednu, jih je 47 (80% odzivnih v 48. tednu) ostalo odzivnih ob 96. tednu.
English: What you need to know before you take PREZISTA
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo PREZISTA
English: Oral suspension 200 ml
Slovenian: peroralna suspenzija 200 ml
English: Elbasvir/grazoprevir to treat hepatitis C infection
Slovenian: elbasvir/grazoprevir za zdravljenje okužbe z virusom hepatitisa C
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer to the relevant product information for these medicinal products.
Slovenian: V primeru sočasnega protivirusnega zdravljenja hepatitisa B ali C, upoštevajte tudi navodila za uporabo teh zdravil.
English: * Using cross-study comparisons to historical pharmacokinetic data
Slovenian: *medštudijska primerjava s predhodnimi farmakokinetičnimi podatki
English: The clinical relevance of this increase is unknown therefore, PREZISTA should be used with caution.
Slovenian: Klinični pomen tega povišanja ni znan, zato je potrebna previdnost pri uporabi zdravila PREZISTA.
English: 90 film-coated tablets (3 bottles containing 30 tablets each) The bottles are not to be distributed individually.
Slovenian: 90 filmsko obloženih tablet (3 plastični vsebniki, en vsebnik vsebuje 30 tablet) Plastenk se ne sme izdajati posamezno.
English: (not applicable for PREZISTA co-administered with ritonavir)
Slovenian: (ne velja za uporabo zdravila PREZISTA skupaj z ritonavirjem)
English: However, unbound darunavir concentrations were approximately 55% (Child-Pugh Class A) and 100% (Child-Pugh Class B) higher, respectively.
Slovenian: Koncentracije nevezanega darunavirja pa so bile približno 55 % (razred A po Child-Pughovi lestvici) in 100 % (razred B po Child-Pughovi lestvici) višje.
English: Increasing the dose of ritonavir from that recommended in section 4.2 did not significantly affect darunavir concentrations.
Slovenian: Zvečanje odmerka ritonavirja, nad vrednost priporočeno v poglavju 4.2, ni pomembno vplivalo na koncentracijo darunavirja.
English: Close the bottle with the cap after use, and store PREZISTA oral suspension as directed in section 5 below.
Slovenian: Steklenico po uporabi zaprite z zaporko in zdravilo PREZISTA peroralna suspenzija shranite kot je navedeno spodaj v poglavju 5.
English: Because of both the potential for HIV transmission and the potential for adverse reactions in breast-fed infants, mothers should be instructed not to breast-feed under any circumstances if they are receiving PREZISTA.
Slovenian: Zaradi možnosti za prenos okužbe s HIV in možnosti za neželene učinke pri dojenčkih, je treba materam naročiti, naj v nobenem primeru ne dojijo, če jemljejo zdravilo PREZISTA.
English: PREZISTA/ritonavir 10 kg to < 15 kg N=5
Slovenian: PREZISTA/ritonavir 10 kg do < 15 kg n=5
English: Take the dose of PREZISTA.
Slovenian: Vzemite odmerek zdravila PREZISTA.
English: 6/l (see section 4.2 and 4.4).
Slovenian: 6/l (glejte poglavji 4.2 in 4.4).
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Other medicines and PREZISTA Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo.
English: Paediatric population The safety assessment in paediatric patients is based on the 48-week analysis of safety data from three Phase II trials.
Slovenian: Pediatrična populacija Ocena varnosti pri pediatričnih bolnikih temelji na analizi podatkov o varnosti zdravila po 48 tednih iz treh preskušanj faze II.
English: The unbound fraction was also substantially reduced, including around 90% reductions of
Slovenian: Bistveno manj je bilo tudi nevezane frakcije, vključno s znižanjem Cmin.za približno 90%.
English: Use the dosing pipette supplied with the pack to measure your dose accurately: Shake the bottle well before each use.
Slovenian: Navodila za uporabo Za določitev natančnega odmerka uporabite priloženo odmerno kapalko: Pred vsako uporabo steklenico dobro pretresite.
English: PREZISTA oral suspension Janssen Pharmaceutica NV Turnhoutseweg 30
Slovenian: PREZISTA peroralna suspenzija Janssen Pharmaceutica NV Turnhoutseweg 30
English: Do not combine PREZISTA with any of the following medicines If you are taking any of these, ask your doctor about switching to another medicine.
Slovenian: Zdravila PREZISTA ne smete kombinirati z nobenim od naslednjih zdravil Če jemljete katero od naštetih zdravil, prosite zdravnika, naj vam predpiše drugo zdravilo.
English: • For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.
Slovenian: • za zdravljenje okužbe s HIV-1 pri odraslih bolnikih, ki imajo izkušnje s protiretrovirusnim zdravljenjem (ART - antiretroviral treatment), vključno s tistimi, ki so prejeli že več različnih vrst zdravljenj
English: Darunavir is an inhibitor of the dimerisation and of the catalytic activity of the HIV-1 protease (KD of 4.5 x 10
Slovenian: Mehanizem delovanja Darunavir je zaviralec dimerizacije in katalitične aktivnosti proteaze HIV-1 (KD 4,5 x 10
English: PREZISTA oral suspension can be used in patients unable to swallow PREZISTA tablets.
Slovenian: Zdravilo PREZISTA peroralna suspenzija se lahko uporablja pri bolnikih, ki tablet zdravila PREZISTA ne morejo pogoltniti.
English: Your doctor will advise you how to deal with your symptoms or whether PREZISTA must be stopped.
Slovenian: Zdravnik vam bo povedal, kako glede na vaše simptome ravnati in ali je treba prekiniti zdravljenje z zdravilom PREZISTA.
English: According to current treatment guidelines, dual therapy with protease inhibitors is generally not recommended.
Slovenian: Skladno s trenutno veljavnimi smernicami, sočasno zdravljenje z dvema zaviralcema proteaze večinoma ni priporočljivo.
English: The below list of examples of drug drug interactions is not comprehensive and therefore the label of each drug that is co-administered with PREZISTA should be consulted for information related to the route of metabolism, interaction pathways, potential risks, and specific actions to be taken with regards to co-administration.
Slovenian: Seznam primerov medsebojnega delovanja med posameznimi učinkovinami v spodnji preglednici ni popoln, zato je treba za vsako zdravilo, ki se jemlje sočasno z zdravilom PREZISTA, pregledati podatke o poti presnove, interakcijah, morebitnih tveganjih in posebnih ukrepih ob sočasni uporabi.
English: What PREZISTA is and what it is used for What you need to know before you take PREZISTA How to take PREZISTA
Slovenian: Kaj je zdravilo PREZISTA in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo PREZISTA Kako jemati zdravilo PREZISTA Možni neželeni učinki
English: The direction of the arrow for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range (not determined as “ND”).
Slovenian: Smer puščice je za vsak farmakokinetični parameter določena na osnovi 90% intervala zaupanja geometričnega povprečnega razmerja, ki je znotraj (↔), pod (↓) ali nad (↑) območjem 80-125% spremembe (ni podatka je prikazano z “ND”).
English: based on published data with darunavir/ritonavir rosuvastatin AUC ↑ 93% rosuvastatin Cmax ↑ 277% rosuvastatin Cmin ND
Slovenian: na osnovi objavljenih podatkov s kombinacijo darunavir/ritonavir rosuvastatin AUC ↑ 93% rosuvastatin Cmax ↑ 277% rosuvastatin Cmin ND
English: more than 40 kilograms
Slovenian: več kot 40 kilogramov
English: There is no specific antidote for overdose with PREZISTA.
Slovenian: Za preveliko odmerjanje zdravila PREZISTA ni specifičnega antidota.
English: - Take PREZISTA with food.
Slovenian: - Zdravilo PREZISTA jemljite s hrano.
English: Ethinylestradiol Norethindrone 35 g/1 mg once daily
Slovenian: etinilestradiol noretisteron 35 g/1 mg enkrat na dan
English: TITAN Week 48
Slovenian: TITAN 48. teden
English: If prescribed PREZISTA twice daily the child must take one dose in the morning, and one dose in the evening.
Slovenian: Če se otroku predpiše zdravilo PREZISTA dvakrat na dan, mora vzeti en odmerek zjutraj in enega zvečer.
English: The efficacy and safety of the use of PREZISTA with 100 mg ritonavir and any other HIV PI (e.g. (fos)amprenavir, nelfinavir and tipranavir) has not been established in HIV patients.
Slovenian: Učinkovitost in varnost sočasne uporabe zdravila PREZISTA skupaj s 100 mg ritonavirja in drugimi PI (npr. (fos)amprenavir, nelfinavir in tipranavir) pri bolnikih s HIV nista bili ugotovljeni.