FrancophonIA/ELRC3.0 huggingface dataset:
English: • certain medicines (so called tyrosine kinase inhibitors) used to treat different types of cancer such as dasatinib and sunitinib.
Slovenian: • nekatera zdravila (imenovana zaviralci tirozin kinaze), ki se uporabljajo za zdravljenje nekaterih vrst raka - kot sta dasatinib in sunitinib.
English: • The active substance is saquinavir.
Slovenian: • Učinkovina je sakvinavir.
English: Pharmaco-therapeutic group: Antiviral agent, ATC code J05A E01
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, oznaka ATC: J05A E01
English: Other potential interactions Medicinal products that are substrates of CYP3A4 e.g. dapsone, disopyramide, quinine, fentanyl, and alfentanyl
Slovenian: Druge možne interakcije Zdravila, ki so substrati CYP3A4 npr. dapson, disopiramid, kinin, fentanil in alfentanil
English: The mean steady-state volume of distribution following intravenous administration of a 12 mg dose of saquinavir was 700 l (CV 39 %).
Slovenian: Povprečni volumen porazdelitve v stanju dinamičnega ravnovesja po intravenskem dajanju 12 mg odmerka sakvinavirja je bil 700 l (CV 39 %).
English: Infection: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after antiHIV treatment is started.
Slovenian: Okužbe: Pri nekaterih bolnikih z napredovalo okužbo s HIV (AIDS) in z oportunistično okužbo v anamnezi se lahko kmalu po začetku anti-HIV zdravljenja pojavijo znaki in simptomi vnetja, povezani s prejšnjimi okužbami.
English: Safety pharmacology: Cloned human cardiac potassium channel (hERG) trafficking in vitro was inhibited by 75% at 30μM of saquinavir.
Slovenian: Farmakološka varnost: in vitro je bilo prehajanje skozi klonirane človeške kalijeve kanalčke v srcu (hERG) ovirano za 75 % pri koncentraciji 30 µM sakvinavirja.
English: There are some medications that must not be taken with Invirase/ritonavir (see section "Do not take Invirase if you are taking any of the following medicines:" above).
Slovenian: Nekaterih zdravil ne smete jemati skupaj z zdravilom Invirase/ritonavirjem (glejte odstavek ''Ne jemljite zdravila Invirase, če jemljete katero koli izmed naštetih zdravil'' zgoraj).
English: Change in Baseline Plasma HIV-1 RNA at Weeks 12-20
Slovenian: Sprememba v izhodiščnih plazemskih koncentracijah HIV-1 RNA v tednih 12-20
English: Discontinued assigned treatment, n (%)
Slovenian: vpeljano sprejeto zdravljenje, n (%) prekinjeno sprejeto zdravljenje, n (%)
English: • recently taken the HIV medicine rilpivirine.
Slovenian: • ste nedavno uporabili rilpivirin, zdravilo za zdravljenje okužbe z virusom HIV.
English: The pharmacokinetics of saquinavir is stable during long-term treatment.
Slovenian: Med dolgotrajnim zdravljenjem je farmakokinetika sakvinavirja stabilna.
English: • medicines for other severe mental health problems - such as clozapine, haloperidol,
Slovenian: • zdravila proti ostalim hudim duševnim zdravstvenim težavam - kot so klozapin, haloperidol,
English: Maraviroc Cmax: ↑ 3.78
Slovenian: Cmax maraviroka ↑ 3,78
English: Table 10: Pharmacokinetic parameters of saquinavir at steady-state in HIV-infected pediatric patients
Slovenian: Preglednica 10: Farmakokinetični parametri sakvinavirja v stanju dinamičnega ravnovesja pri pediatričnih bolnikih okuženih s HIV
English: Maraviroc AUC12 ↑ 8.77
Slovenian: AUC12 maraviroka ↑ 8,77
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC ODGOVOREN ZA SPROŠČANJE SERIJ
English: Co-administration of saquinavir and ritonavir has led to severe adverse events, mainly diabetic ketoacidosis and liver disorders, especially in patients with preexisting liver disease.
Slovenian: Sočasno dajanje sakvinavirja in ritonavirja je vodilo v resne neželene dogodke, predvsem v diabetično ketoacidozo in motnje jetrnega delovanja, še posebno pri bolnikih s prej obstoječim obolenjem jeter.
English: Saquinavir AUC ↑ 348%.
Slovenian: AUC sakvinavirja ↑ 348 %.
English: Interaction with HMG-CoA reductase inhibitors: Caution must be exercised if Invirase/ritonavir is used concurrently with atorvastatin, which is metabolised to a lesser extent by CYP3A4.
Slovenian: Medsebojno delovanje z zaviralci HMG-CoA reduktaze: previdnost je potrebna, če se zdravilo Invirase/ritonavir uporablja sočasno z atorvastatinom, ki se v manjši meri presnavlja s CYP3A4.
English: • quetiapine - used to treat schizophrenia, bipolar disorder and major depressive disorder
Slovenian: • kvetiapin - za zdravljenje shizofrenije, bipolarne motnje in velike depresije,
English: A decrease in the dose of the benzodiazepine may be required.
Slovenian: Odmerek benzodiazepina bo morda treba zmanjšati.
English: There was no QT prolongation > 500 msec and no torsade de pointes in the study (see also section 4.4).
Slovenian: V študiji ni bilo aritmije vrste torsade de pointes in podaljšanja intervala QT > 500 msek (glejte tudi poglavje 4.4).
English: • decompensated liver disease (see section 4.4)
Slovenian: • dekompenzacijsko ledvično boleznijo (glejte poglavje 4.4),
English: Carcinogenesis: There was no evidence of carcinogenic activity after the administration of saquinavir mesilate for 96 to 104 weeks to rats and mice.
Slovenian: Kancerogeneza: po dajanju sakvinavirjevega mesilata podganam in mišim 96 do 104 tedne ni bilo dokazov kancerogenega delovanja.
English: Invirase/ritonavir may increase concentrations of tricyclic antidepressants.
Slovenian: Zdravilo Invirase/ritonavir lahko zviša koncentracijo tricikličnih antidepresivov.
English: If concomitant use is deemed necessary because the potential benefit to the patient outweighs the risk, particular caution is warranted (see section 4.4; for information on individual drugs, see Table 1).
Slovenian: Potrebna je določena previdnost, če se smatra, da je sočasna uporaba potrebna, ker potencialna korist za bolnika odtehta tveganje (glejte poglavje 4.4, za podatke o posameznih zdravilih glejte preglednico 1).
English: Invirase is indicated for the treatment of HIV-1 infected adult patients.
Slovenian: Zdravilo Invirase je indicirano za zdravljenje odraslih bolnikov, okuženih s HIV-1.
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Slovenian: Bolniki s predhodnimi obolenji jeter, vključno s kroničnim aktivnim hepatitisom, imajo med kombiniranim protiretrovirusnim zdravljenjem povečano pogostnost nepravilnosti delovanja jeter in jih je zato treba spremljati v skladu s standardnimi postopki.
English: In combination with ritonavir, bioequivalence of Invirase hard capsules and film-coated tablets was demonstrated under fed conditions.
Slovenian: V kombinaciji z ritonavirjem je bila bioekvivalenca zdravila Invirase trdih kapsul in filmsko obloženih tablet dokazana pri jemanju s hrano.
English: Invirase is used by HIV-1-infected adults.
Slovenian: Zdravilo Invirase uporabljajo odrasli, okuženi s HIV-1.
English: Monitoring of saquinavir plasma concentration might be indicated.
Slovenian: Zato bo morda potrebno spremljanje koncentracije sakvinavirja v plazmi.
English: • congenital or documented acquired QT prolongation
Slovenian: • prirojenim ali dokumentirano pridobljenim podaljšanjem intervala QT,
English: If the combination is considered necessary, monitoring of the saquinavir plasma levels is strongly encouraged (see section
Slovenian: Če se smatra, da je ta kombinacija potrebna, se spremljanje koncentracije sakvinavirja v plazmi močno priporoča (glejte poglavje
English: The geometric mean ratio (ratio of pharmacokinetic parameters in hepatically impaired patients to patients with normal liver function) (90% confidence interval) was 0.7 (0.3 to 1.6) for both AUC0-12 and Cmax, which suggests approximately 30% reduction in the pharmacokinetic exposure in patients with moderate hepatic impairment.
Slovenian: Povprečno geometrično razmerje (razmerje farmakokinetičnih parametrov med bolniki z jetrno okvaro in bolniki z normalno jetrno funkcijo) (interval zaupanja 90 %) je bilo 0,7 (0,3 do 1,6) za obe AUC0-12 in Cmax, kar kaže na približno 30 % zmanjšanje farmakokinetične izpostavljenosti pri bolnikih z zmerno jetrno okvaro.
English: Plasma concentrations of trazodone may increase.
Slovenian: Plazemske koncentracije trazodona se lahko zvišajo.
English: The G48V mutation, previously identified in vitro as a saquinavir signature mutation, was present at baseline in virus from three patients, none of whom responded to therapy.
Slovenian: Mutacija G48V, ki je bila in vitro prepoznana kot značilna mutacija, povezana s sakvinavirjem, je bila ob začetku zdravljenja prisotna pri virusu treh bolnikov, ki se na zdravljenje niso odzvali.
English: • concurrent therapy with any of the following drugs, which may interact and result in potentially life-threatening undesirable effects (see sections 4.4, 4.5 and 4.8): - drugs that prolong the QT and/or PR interval (see sections 4.4 and 4.5) - midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), triazolam (potential for prolonged or increased sedation, respiratory depression) - simvastatin, lovastatin (increased risk of myopathy including rhabdomyolysis) - ergot alkaloids (e.g. ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (potential for acute ergot toxicity) - rifampicin (risk of severe hepatocellular toxicity) (see sections 4.4, 4.5, and 4.8) - quetiapine (risk of coma, see section 4.5).
Slovenian: • sočasno terapijo s katerim od naslednjih zdravil, ki lahko medsebojno delujejo in povzročijo potencialno življenjsko ogrožajoče neželene učinke, (glejte poglavja 4.4, 4.5 in 4.8): - zdravila, ki podaljšajo interval QT in/ali PR (glejte poglavji 4.4 in 4.5), - midazolam, dan peroralno (za previdnost pri parenteralnih oblikah midazolama glejte poglavje 4.5), triazolam (možnost nastanka podaljšane ali povečane sedacije, respiratorne depresije), - simvastatin in lovastatin (povečano tveganje za miopatijo vključno z rabdomiolizo), - ergot alkaloide (npr. ergotamin, dihidroergotamin, ergonovin in metilergonovin) (možnost akutne ergot toksičnosti), - rifampicin (tveganje za hudo hepatocelularno toksičnost) (glejte poglavja 4.4, 4.5 in 4.8), - kvetiapin (tveganje za nastop kome, glejte poglavje 4.5), - lurasidon (možnost nastanka resnih in/ali življenjsko ogrožajočih reakcij, glejte poglavje 4.5).
English: Liver disease: The safety and efficacy of saquinavir/ritonavir has not been established in patients with significant underlying liver disorders, therefore saquinavir/ritonavir should be used cautiously in this patient population.
Slovenian: Bolezni jeter: varnosti in učinkovitosti sakvinavirja/ritonavirja pri bolnikih z obstoječimi značilnimi motnjami jetrnega delovanja niso raziskali, zato se mora sakvinavir/ritonavir pri tej populaciji bolnikov uporabljati previdno.
English: Breast-feeding: There are no laboratory animal or human data available on secretion of saquinavir in breast milk.
Slovenian: Dojenje: o izločanju sakvinavirja v materino mleko ni na voljo nobenih laboratorijskih podatkov iz raziskav pri živalih ali ljudeh.
English: • If you are taking any medicine that decreases your blood potassium levels talk to your doctor before taking Invirase.
Slovenian: • Če jemljete katero koli zdravilo, ki znižuje raven kalija v krvi, se pred jemanjem zdravila
English: Since saquinavir is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.
Slovenian: Ker se sakvinavir močno veže na krvne proteine, dializa pri znatnem odstranjevanju učinkovine verjetno ne bo koristna.
English: Paediatric population: The safety and activity of saquinavir boosted with ritonavir in HIV-infected patients less than 2 years have not been established.
Slovenian: Pediatrična populacija: varnost in delovanje sakvinavirja s podporno terapijo z ritonavirjem pri bolnikih, okuženih s HIV, starih manj kot 2 leti, nista bili dokazani.
English: Calcium channel blockers Felodipine, nifedipine, nicardipine, diltiazem, nimodipine, verapamil, amlodipine, nisoldipine, isradipine (saquinavir/ritonavir)
Slovenian: Blokatorji kalcijevih kanalov felodipin, nifedipin, nikardipin, diltiazem, nimodipin, verapamil, amlodipin, nisoldipin, isradipin (sakvinavir/ritonavir)
English: Tyrosine kinase inhibitors All tyrosine kinase inhibitors with a risk of QT prolongation e.g. dasatinib, sunitinib
Slovenian: Zaviralci tirozin kinaze Vsi zaviralci tirozin kinaze s tveganjem za podaljšanje intervala QT, npr. dasatinib sunitinib
English: Patients on saquinavir treatment must not take garlic capsules due to the risk of decreased plasma concentrations and loss of virological response and possible resistance to one or more components of the antiretroviral regimen.
Slovenian: Bolniki, ki se zdravijo s sakvinavirjem, zaradi tveganja znižanja plazemskih koncentracij in izgube virološkega odziva ter možne odpornosti proti eni ali več sestavinam protiretrovirusnega zdravljenja ne smejo jemati kapsul s česnom.
English: Median increase in CD4 cell count at week 48 (cells/mm3) * For both studies: For patients entering study with VL < 200 copies/ml, VF defined as > 200 copies/ml.
Slovenian: mediana povečanja števila celic CD4 v 48. tednu (cellic/mm * Za obe študiji: za bolnike, ki so vstopili v študijo z virusnim bremenom (VL - virial load) < 200 kopij/ml, pomanjkanje virološkega odziva (VF - virial failure) je definiran kot > 200 kopij/ml.
English: If you are not sure, talk to your doctor or pharmacist before taking Invirase.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom preden vzamete zdravilo Invirase.
English: Ritonavir can affect the pharmacokinetics of other medicinal products because it is a potent inhibitor of CYP3A4 and P-gp.
Slovenian: Ritonavir lahko vpliva na farmakokinetiko drugih zdravil, ker je močan zaviralec CYP3A4 in P-gp.
English: Other medicines and Invirase Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Biotransformation and elimination in adults: In vitro studies using human liver microsomes have shown that the metabolism of saquinavir is cytochrome P450 mediated with the specific isoenzyme, CYP3A4, responsible for more than 90 % of the hepatic metabolism.
Slovenian: Biotransformacija in izločanje pri odraslih: v in vitro študijah z uporabo človeških jetrnih mikrosomov so pokazali, da presnova sakvinavirja poteka prek citokroma P450, specifični izoencim CYP3A4 pa je odgovoren za več kot 90 % presnove prek jeter.
English: • a salt imbalance in your blood, especially low blood concentrations of potassium (hypokalaemia),
Slovenian: • imate neravnovesje soli v krvi, še zlasti nizke koncentracije kalija v krvi (hipokaliemija), ki ga trenutno ne zdravite,
English: Mean ddQTcS
Slovenian: Povprečna vrednost ddQTcS
English: Change in Baseline Plasma HIV-1 RNA at Week 4
Slovenian: Sprememba v izhodiščnih plazemskih koncentracijah HIV-1 RNA v tednu 4
English: There have been reports of muscle pain, tenderness or weakness, particularly with combination antiretroviral therapy including protease inhibitors and nucleoside analogues.
Slovenian: Poročali so o bolečinah v mišicah, občutljivosti na dotik v mišicah ali šibkosti mišic, posebno pri kombiniranem protiretrovirusnem zdravljenju, ki vključuje zaviralce proteaz in nukleozidne analoge.
English: Ritonavirboosted Invirase at a dose of 2000 mg once daily with ritonavir 100 mg once daily has not been studied with regard to the risk of QT prolongation and is not recommended.
Slovenian: Zdravilo Invirase v odmerku 2000 mg enkrat na dan s podporno terapijo z ritonavirjem 100 mg enkrat na dan ni bilo proučevano glede na tveganje za podaljšanje QT intervala in se zato ne priporoča.
English: If a patient is already taking St. John's wort, stop St. John's wort, check viral levels and if possible saquinavir levels.
Slovenian: Če bolnik že jemlje šentjanževko, naj z jemanjem šentjanževke preneha, nato preverite ravni virusa in, če je mogoče, koncentracije sakvinavirja.
English: If treatment with a HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended with careful monitoring (see section
Slovenian: Če je indicirano zdravljenje z zaviralcem HMG-CoA reduktaze, se priporoča uporaba pravastatina ali fluvastatina s skrbnim spremljanjem (glejte poglavje 4.5).
English: Increased concentrations of simvastatin and lovastatin have been associated with rhabdomyolysis.
Slovenian: Zvišane koncentracije simvastatina in lovastatina so bile povezane z rabdomiolizo.
English: • a weak heart (heart failure)
Slovenian: • imate šibko srce (srčno popuščanje),
English: Caution should be exercised in patients with severe renal impairment (see section 4.4).
Slovenian: Previdnost je potrebna pri bolnikih s hudo ledvično okvaro (glejte poglavje 4.4).
English: • previous history of symptomatic arrhythmias
Slovenian: • anamnezo simptomatske aritmije,
English: Women and elderly patients may be more susceptible to drug-associated effects on the QT and/or PR interval.
Slovenian: Ženske in starejši bolniki so lahko bolj občutljivi na z zdravilom povezane učinke na interval QT in/ali PR.
English: No dose recommendations for paediatric patients ≥2 years of age could be established that are both effective and below thresholds of concern for QT and PR interval prolongation.
Slovenian: Priporočil za odmerjanje pri pediatričnih bolnikih, starih ≥ 2 leti, ki bi omogočilo, da bi bili obe zdravili učinkoviti in pod pragom tveganja za podaljšanje intervala QT in PR, niso mogli določiti.
English: • medicines to treat depression - such as nefazodone, tricyclic antidepressants
Slovenian: • zdravila za zdravljenje depresije - kot so nefazodon, triciklični antidepresivi,
English: There are also some medicines that require dosage reduction of that medicine or Invirase or ritonavir (see section “Medicines that can interact with saquinavir or ritonavir include:” below).
Slovenian: Obstajajo tudi zdravila, katerih odmerek ali odmerek zdravila Invirase ali ritonavirja je treba zmanjšati (glejte odstavek ''Zdravila, ki lahko medsebojno delujejo s sakvinavirjem ali ritonavirjem'' spodaj).
English: • antifungals - ketoconazole, itraconazole, fluconazole, miconazole
Slovenian: • antimikotiki - ketokonazol, itrakonazol, flukonazol, mikonazol,
English: Following intravenous administration 66 % of circulating saquinavir was present as unchanged compound and the remainder as metabolites, suggesting that saquinavir undergoes extensive first pass metabolism.
Slovenian: Po intravenskem dajanju je 66 % sakvinavirja v krvnem obtoku nespremenjenega, ostalo pa v obliki presnovkov, kar kaže, da je sakvinavir podvržen obsežni presnovi prvega prehoda.
English: The plasma exposures (AUC values) in rats (maximum dose 1000 mg/kg/day) and in mice (maximum dose 2500 mg/kg/day) were lower than the expected plasma exposures obtained in humans at the recommended clinical dose of ritonavir boosted Invirase.
Slovenian: Plazemske izpostavitve (vrednosti AUC) v podganah (največji odmerek 1000 mg/kg/dan) in v miših (največji odmerek 2500 mg/kg/dan) so bile nižje od pričakovanih plazemskih izpostavitev, doseženih pri ljudeh ob priporočenem kliničnem odmerku zdravila Invirase s podporno terapijo z ritonavirjem.
English: On Day 3 of dosing, ECG measurements were done over a period of 20 hours.
Slovenian: EKG meritve so bile narejene v času 20 ur na 3 dan odmerjanja.
English: Bone problems: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Slovenian: Težave s kostmi: pri nekaterih bolnikih, ki jemljejo kombinirano protiretrovirusno zdravljenje, se lahko pojavi bolezen kosti, imenovana osteonekroza (odmiranje kostnega tkiva zaradi nezadostne prekrvitve kosti).
English: Endothelin receptor antagonist Bosentan
Slovenian: Zaviralci endotelijskih receptorjev bosentan
English: In vitro studies have shown that saquinavir is a substrate for P-glycoprotein (P-gp).
Slovenian: In vitro študije so pokazale, da je sakvinavir substrat P-glikoproteina (P-gp).
English: • some medicines affecting the immune system - such as ciclosporin, sirolimus (rapamycin),
Slovenian: • nekatera zdravila, ki delujejo na imunski sistem - kot so ciklosporin, sirolimus (rapamicin),
English: Table 1: Interactions and dose recommendations with other medicinal products Medicinal product by therapeutic area (dose of
Slovenian: Preglednica 1: Medsebojno delovanje z drugimi zdravili in priporočila za odmerjanje pri sočasni uporabi drugih zdravil
English: Osteonecrosis: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Slovenian: Osteonekroza: čeprav je vzrokov verjetno več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo imunosupresijo, višjim indeksom telesne mase), so o primerih osteonekroze poročali zlasti pri bolnikih z napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART - combination antiretroviral therapy) ali obojim.
English: Since the magnitude of QT and PR prolongation increases with increasing concentrations of saquinavir, the recommended dose of ritonavir-boosted Invirase should not be exceeded.
Slovenian: Ker se z zvišanjem koncentracij sakvinavirja podaljšata tudi intervala QT in PR, se priporočenega odmerka zdravila Invirase s podporno terapijo z ritonavirjem ne sme preseči.
English: In patients with haemophilia type A and B, there have been reports of increased bleeding while taking this treatment or another protease inhibitor.
Slovenian: Pri bolnikih s hemofilijo tipov A in B so poročali o povečanem krvavenju med jemanjem tega zdravila ali drugega zaviralca proteaz.
English: • a very slow heart rate (bradycardia)
Slovenian: • imate zelo počasen srčni utrip (bradikardijo),
English: Proportion with VL < 50 copies/ml at week 48, On Treatment
Slovenian: razmerje z virusnim bremenom VL < 50 kopij/ml v 48. tednu, na zdravljenju
English: Ritonavir-boosted Invirase should be discontinued if arrhythmias are demonstrated, or if prolongation occurs in the QT or PR interval.
Slovenian: Zdravljenje z zdravilom Invirase s podporno terapijo z ritonavirjem je treba prekiniti, če se pokažejo aritmije ali če se pojavi podaljšanje intervala QT ali PR.
English: • certain medicines that may be used for a variety of things: cisapride, diphemanil, mizolastine,
Slovenian: • nekatera zdravila, ki se lahko uporabljajo za različne stvari: cisaprid, difemanil, mizolastin,
English: Steady state saquinavir exposures observed in paediatric trials were substantially higher than historical data in adults where dose- and exposure-dependent QTc and PR prolongation were observed (see section 4.4).
Slovenian: Opazili so, da je bila v stanju dinamičnega ravnovesja izpostavljenost sakvinavirju v pediatričnih študijah bistveno višja od preteklih podatkov pri odraslih, kjer so opazili od odmerka in izpostavljenosti odvisno podaljšanje intervala QTc in PR (glejte poglavje 4.4).
English: MARKETING AUTHORISATION NUMBER EU/1/96/026/002
Slovenian: EU/1/96/026/002
English: Invirase 500 mg film-coated tablets are light orange to greyish or brownish orange tablets of oval shape with the marking "SQV 500" on one side and "ROCHE" on the other side.
Slovenian: Invirase 500 mg filmsko obložene tablete so svetlo oranžne do sivkasto ali rjavkasto oranžne barve, ovalne oblike z oznako ''SQV 500'' na eni strani in ''ROCHE'' na drugi strani.
English: Increased plasma concentrations of quetiapine may lead to coma (see sectin 4.3).
Slovenian: Zvišane plazemske koncentracije kvetiapina lahko povzročijo komo (glejte poglavje 4.3).