FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients without this disease may use sildenafil for impotence (erectile dysfunction) under their doctor's supervision (see the section on Other medicines and Ritonavir Mylan); avanafil or vardenafil (used to treat erectile dysfunction); colchicine (used to treat gout) if you have kidney and/or liver problems (see the section on Other medicines and Ritonavir Mylan); products containing St John's wort (Hypericum perforatum) as this may stop ritonavir from working properly.
Slovenian: Bolniki brez te bolezni lahko sildenafil uporabljajo za impotenco (erektilno disfunkcijo) pod nadzorom svojega zdravnika (glejte poglavje Druga zdravila in zdravilo Ritonavir Mylan), avanafil ali vardenafil (uporabljata se za zdravljenje erektilne disfunkcije), kolhicin (uporablja se za zdravljenje protina), če imate težave z ledvicami in/ali jetri (glejte poglavje Druga zdravila in zdravilo Ritonavir Mylan), zdravila, ki vsebujejo šentjanževko (Hypericum perforatum), ker ta lahko onemogoči pravilno delovanje ritonavirja.
English: Atorvastatin is less dependent on CYP3A for metabolism.
Slovenian: Presnova atorvastatina je manj odvisna od CYP3A.
English: Increased plasma concentrations of lomitapide (see section 4.5).
Slovenian: Zvišane plazemske koncentracije lomitapida (glejte poglavje 4.5).
English: HMG Co-A reductase inhibitors
Slovenian: Zaviralci reduktaze HMGCoA
English: HCV Direct Acting Antiviral Glecaprevir/pibrentasvir
Slovenian: Glekaprevir/pibrentasvir
English: Life-threatening and fatal drug interactions have been reported in patients treated with colchicine and ritonavir (CYP3A4 and P-gp inhibition) in patients with renal and/or hepatic impairment (see sections 4.3 and 4.4).
Slovenian: Življenjsko ogrožujoče interakcije zdravil in tiste s smrtnim izidom so bile poročane pri bolnikih zdravljenih s kolhicinom in ritonavirjem (zaviranje CYP3A4 in P-gp) pri bolnikih z okvaro ledvic in/ali jeter (glejte poglavji 4.3 in 4.4).
English: Do not store above 30C.
Slovenian: Shranjujte pri temperaturi do 30°C.
English: Rare reports of 2nd or 3rd degree atrioventricular block in patients with underlying structural heart disease and pre-existing conduction system abnormalities or in patients receiving medicinal products known to prolong the PR interval (such as verapamil or atazanavir) have been reported in patients receiving ritonavir.
Slovenian: Med zdravljenjem z ritonavirjem so redko poročali o atrioventrikularnem bloku 2. ali 3. stopnje pri bolnikih, ki so imeli osnovno strukturno bolezen in že obstoječe nepravilnosti prevodnega sistema, in bolnikih, zdravljenih z zdravili, ki podaljšajo interval PR (npr. verapamil ali atazanavir).
English: Since the renal clearance of ritonavir is negligible, the decrease in the total body clearance is not expected in patients with renal impairment (see also section 4.2).
Slovenian: Ker je ledvični očistek ritonavirja zanemarljiv, pri bolnikih z okvaro ledvic ni pričakovati zmanjšanja celotnega telesnega očistka (glejte tudi poglavje 4.2).
English: Human experience of acute overdose with ritonavir is limited.
Slovenian: Izkušenj z akutnim prevelikim odmerjanjem ritonavirja pri ljudeh je malo.
English: Antidepressants Amitriptyline, fluoxetine, imipramine, nortriptyline, paroxetine, sertraline
Slovenian: Amitriptilin, fluoksetin, imipramin, nortriptilin, paroksetin, sertralin
English: Herbal preparations containing St John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of ritonavir (see section 4.5).
Slovenian: Zdravila rastlinskega izvora s šentjanževko (Hypericum perforatum) zaradi tveganja za znižanje plazemske koncentracije in kliničnih učinkov ritonavirja (glejte poglavje 4.5).
English: Increased plasma concentrations of avanafil (see sections 4.4. and 4.5).
Slovenian: Zvišana plazemska koncentracija avanafila (glejte poglavji 4.4 in 4.5).
English: There have been reports of muscle pain, tenderness or weakness, particularly when taking medicines to lower cholesterol in combination with antiretroviral therapy, including protease inhibitors and nucleoside analogues.
Slovenian: Opisane so bile bolečine v mišicah, občutljivost ali šibkost mišic, zlasti med sočasnim jemanjem zdravil za znižanje holesterola in protiretrovirusnih zdravil, vključno z zaviralci proteaz in nukleozidnimi analogi.
English: 3mg/kg q8h 500q12h ↓ 43% ↓ 32% An increased dose of theophyline may be required when co-administered with ritonavir, due to induction of CYP1A2.
Slovenian: 3mg/kg na 8 ur 500 na 12 ur ↓ 43% Zaradi indukcije CYP1A2 utegne biti med sočasno uporabo z ritonavirjem potreben večji odmerek teofilina.
English: Increased plasma concentrations of lovastatin and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (see section 4.5).
Slovenian: Zvišana koncentracija lovastatina in simvastatina v plazmi; s tem se poveča tveganje za miopatijo, vključno z rabdomiolizo (glejte poglavje 4.5).
English: rifabutin (used to prevent/treat certain infections)*; voriconazole (used to treat fungal infections)*; simvastatin, lovastatin (used to lower blood cholesterol); neratinib (used to treat breast cancer); lomitapide (used to lower blood cholesterol); alfuzosin (used to treat enlarged prostate gland); fusidic acid (used to treat bacterial infections); sildenafil if you suffer from a lung disease called pulmonary arterial hypertension that makes breathing difficult.
Slovenian: rifabutin (uporablja se za preprečevanje ali zdravljenje določenih okužb)*, vorikonazol (uporablja se za zdravljenje glivičnih okužb)*, simvastatin, lovastatin (uporabljata se za zniževanje holesterola v krvi), neratinib (uporablja se za zdravljenje raka dojk), lomitapid (uporablja se za zniževanje holesterola v krvi), alfuzosin (uporablja se za zdravljenje povečane žleze prostate), fusidno kislino (uporablja se za zdravljenje bakterijskih okužb), sildenafil, če imate pljučno bolezen, ki jo imenujemo pljučna arterijska hipertenzija, ki oteži dihanje.
English: In a study completed in 2003, 50 HIV-1 infected, protease inhibitor and lamivudine naïve children age 4 weeks to 2 years received ritonavir 350 or 450 mg/m every 12 hours co-administered with zidovudine 160 mg/m every 8 hours and lamivudine 4 mg/kg every 12 hours.
Slovenian: V študiji, dokončani leta 2003, je 50 otrok, starih od 4 tedne do 2 leti, ki so bili okuženi s HIV-1 in še niso dobivali zaviralcev proteaz in lamivudina, dobivalo ritonavir 350 ali 450 mg/m na 12 ur sočasno z zidovudinom 160 mg/m2 na 8 ur in lamivudinom 4 mg/kg na 12 ur.
English: Decreased white blood cells, decreased haemoglobin, decreased neutrophils, increased eosinophils, thrombocytopenia
Slovenian: Bolezni krvi in limfatičnega sistema pogosti zmanjšanje števila levkocitov, znižanje hemoglobina, zmanjšanje števila nevtrofilcev, povečanje števila eozinofilcev, trombocitopenija občasni povečanje števila nevtrofilcev
English: Therefore, if co-administration of delamanid with ritonavir is considered necessary, very frequent ECG monitoring throughout the full delamanid treatment period is recommended (see section 4.5 and refer to the delamanid Summary of Product Characteristics).
Slovenian: Zato se v primeru, če se sočasno dajanje delamanida z ritonavirjem smatra za potrebno, skozi celotno obdobje zdravljenja z delamanidom priporoča zelo pogosto spremljanje z EKG-jem (glejte poglavje 4.5 in poglejte v povzetek glavnih značilnosti zdravila za delamanid).
English: Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection, as these patients have an increased risk of hepatotoxicity.
Slovenian: Posebna pozornost je potrebna pri bolnikih s sočasno okužbo s hepatitisom B ali C, kajti tveganje za toksične učinke na jetrih je pri njih večje.
English: In these studies renal elimination was not found to be a major route of elimination of ritonavir.
Slovenian: V teh raziskavah niso ugotovili, da bi se ritonavir pomembno izločal skozi ledvice.
English: When tadalafil is used concurrently with ritonavir in patients with pulmonary arterial hypertension, refer to the tadalafil Summary of Product Characteristics.
Slovenian: Pri sočasni uporabi tadalafila z ritonavirjem pri bolnikih s pljučno arterijsko hipertenzijo glejte povzetek glavnih značilnosti zdravila za tadalafil.
English: Tissue to plasma ratios of approximately 1 measured in rat lymph nodes suggests that ritonavir distributes into lymphatic tissues.
Slovenian: bezgavkah podgan je bilo izmerjeno razmerje med tkivom in plazmo približno 1, kar kaže, da se ritonavir porazdeljuje v limfno tkivo.
English: Four ritonavir metabolites have been identified in man.
Slovenian: Pri človeku so ugotovili štiri presnovke ritonavirja.
English: Ritonavir should not be given as a pharmacokinetic enhancer or as an antiretroviral agent to patients with decompensated liver disease.
Slovenian: Ritonavirja kot farmakokinetičnega stopnjevalca ali protiretrovirusnega zdravila ne smejo dobiti bolniki z dekompenzirano boleznijo jeter.
English: Mylan S.A.S., 117 Allée des Parcs, Saint-Priest, 69800, France
Slovenian: Mylan S.A.S., 117 Allée des Parcs, Saint-Priest, 69800, Francija Proizvajalci
English: Medicinal product interactions - Ritonavir with antiretroviral agents other than protease inhibitors
Slovenian: Medsebojno delovanje zdravil - ritonavir s protiretrovirusnimi zdravili razen zaviralcev proteaz
English: The tablet coating is composed of: hypromellose, titanium dioxide (E171), macrogols, hydroxypropylcellulose, talc, iron oxide yellow (E172), colloidal anhydrous silica, polysorbate
Slovenian: Sestavine filmske obloge so: hipromeloza, titanov dioksid (E171), makrogoli, hidroksipropilceluloza, smukec, rumeni železov oksid (E172), koloidni brezvodni silicijev dioksid, polisorbat 80.
English: amphetamine or amphetamine derivatives; antibiotics (e.g. erythromycin, clarithromycin); anticancer treatments (e.g. abemaciclib, afatinib, ceritinib, dasatinib, ibrutinib, nilotinib, venetoclax, vincristine, vinblastine); anticoagulants (e.g. rivaroxaban, vorapaxar, warfarin); antidepressants (e.g. amitriptyline, desipramine, fluoxetine, imipramine, nefazodone, nortriptyline, paroxetine, sertraline, trazodone); antifungals (e.g. ketoconazole, itraconazole); antihistamines (e.g. loratadine, fexofenadine); antiretroviral medicines including HIV-protease inhibitors (amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, nelfinavir, saquinavir, tipranavir) non-nucleoside reverse transcriptase inhibitors (NNRTI) (delavirdine, efavirenz, nevirapine), and others (didanosine, maraviroc, raltegravir, zidovudine); anti-tuberculosis medicine (bedaquiline and delamanid); antiviral medicine used to treat chronic hepatitis C virus (HCV) infection in adults (e.g. glecaprevir/pibrentasvir and simeprevir); anxiety medicine, buspirone; asthma medicine, theophylline, salmeterol; atovaquone, a medicine used to treat a certain type of pneumonia and malaria; buprenorphine, a medicine used for the treatment of chronic pain; bupropion, a medicine used to help you stop smoking; epilepsy medicines (e.g. carbamazepine, divalproex, lamotrigine, phenytoin); heart medicines (e.g. disopyramide, mexiletine and calcium channel antagonists such as amlodipine, diltiazem and nifedipine); immune system (e.g. cyclosporine, tacrolimus, everolimus); levothyroxine (used to treat thyroid problems)
Slovenian: amfetamin ali derivate amfetamina; antibiotike (npr. eritromicin, klaritromicin); zdravila proti raku (npr. abemaciklib, afatinib, ceritinib, dasatinib, ibrutinib, nilotinib, venetoklaks, vinkristin, vinblastin); antikoagulanti (npr. rivaroksaban, vorapaksar, varfarin); antidepresive (npr. amitriptilin, dezipramin, fluoksetin, imipramin, nefazodon, nortriptilin, paroksetin, sertralin, trazodon); antimikotike (npr. ketokonazol, itrakonazol); antihistaminike (npr. loratadin, feksofenadin); antiretrovirusna zdravila, vključno z zaviralci proteaz HIV (amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, nelfinavir, sakinavir, tipranavir), zaviralci nenukleozidne reverzne transkriptaze (NNRTI) (delaviridin, efavirenz, nevirapin) in drugi (didanozin, maravirok, raltegravir, zidovudin); zdravilo za zdravljenje tuberkuloze (bedakilin in delamanid); protivirusno zdravilo za zdravljenje kronične okužbe z virusom hepatitisa C (HCV) pri odraslih (npr. glekaprevir/pibrentasvir in simeprevir); zdravila proti tesnobnosti, buspiron; zdravila proti astmi, teofilin, salmeterol; atovakon, zdravilo za zdravljenje določene vrste pljučnice in malarije; buprenorfin, zdravilo za zdravljenje kroničnih bolečin; bupropion, zdravilo, ki se uporablja kot pomoč pri opuščanju kajenja; zdravila proti epilepsiji (npr. karbamazepin, divalproeks, lamotrigin, fenitoin);
English: Hepatitis (including increased AST, ALT, GGT), blood bilirubin increased (including jaundice)
Slovenian: Bolezni jeter, žolčnika in žolčevodov pogosti hepatitis (vključno z zvišanjem AST, ALT, GGT), zvišanje bilirubina v krvi (vključno z zlatenico)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of ritonavir.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 100 mg ritonavirja.
English: 300 q12 h, 3 days
Slovenian: 300 na 12h, 3 dni
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA SKUPNEGA PAKIRANJA (Z MODRIM OKENCEM) 1.
English: Serum concentrations may be increased due to P-glycoprotein, BCRP and OATP1B inhibition by ritonavir.
Slovenian: Serumske koncentracije se lahko zvišajo zaradi zavrtja Pglikoproteina, BCRP in OATP1B z ritonavirjem.
English: Hepatitis B or C and are being treated with a combination of antiretroviral agents, as you are at a greater risk of a severe and potentially life threatening reaction because of the effect on the liver.
Slovenian: hepatitis B ali C in dobivate kombinacijo protiretrovirusnih zdravil: zaradi vpliva na jetra vas namreč v takšnem primeru bolj ogroža huda in lahko smrtno nevarna reakcija.
English: Concomitant use of ritonavir with lomitapide is contraindicated (see prescribing information for lomitapide) (see section 4.3).
Slovenian: Zato je sočasna uporaba ritonavirjem z lomitapidom kontraindicirana (glejte informacije o predpisovanju za lomitapid) (glejte poglavje 4.3).
English: Concomitant medicinal product levels increased or decreased α1-Adrenoreceptor
Slovenian: Zvišanje ali znižanje koncentracije sočasno uporabljenega zdravila ntagonist adrenergičnih receptorjev
English: For additional information on the effect of ritonavir on co-administered protease inhibitor metabolism, see section 4.5 and refer to the Summary of Product Characteristics of the particular co-administered PIs.
Slovenian: Za dodatne informacije o učinku ritonavirja na presnovo sočasno uporabljenega zaviralca proteaz glejte poglavje 4.5 in povzetek glavnih značilnosti za posamezni sočasno uporabljeni zaviralec proteaz.
English: Atorvastatin or rosuvastatin (for high cholesterol) as ritonavir may raise the blood levels of these medicines.
Slovenian: Atorvastatin ali rosuvastatin (zaradi zvišanega holesterola), kajti ritonavir lahko zviša koncentracijo teh zdravil v krvi.
English: Pethidine, piroxicam, propoxyphene
Slovenian: Petidin, piroksikam, propoksifen
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL OF MULTIPACK (WITHOUT BLUE BOX)
Slovenian: NALEPKA ZA PLASTENKO SKUPNEGA PAKIRANJA (BREZ MODREGA OKENCA) 1.
English: Ritonavir Mylan can cause dizziness.
Slovenian: Zdravilo Ritonavir Mylan lahko povzroči omotico.
English: In intent to treat analyses, 72% and 36% of patients achieved reduction in plasma HIV-1 RNA of ≤ 400 copies/ml at Week 16 and 104, respectively.
Slovenian: V analizah z namenom zdravljenja je po 16 tednih 72 % preiskovancev doseglo znižanje plazemskih RNA HIV-1 na ≤ 400 kopij/ml, po 104 tednih pa 36 % preiskovancev.
English: Elderly Pharmacokinetic data indicated that no dose adjustment is necessary for elderly patients (see section
Slovenian: Farmakokinetični podatki kažejo, da prilagoditev odmerka za starejše bolnike ni potrebna (glej poglavje 5.2).
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Slovenian: Potem, ko boste začeli jemati zdravila za zdravljenje okužbe s HIV, se lahko poleg simptomov oportunističnih okužb pojavijo tudi avtoimunske bolezni (stanje, ki se pojavi, ko imunski sistem napade zdravo tkivo).
English: Pancreatitis has been observed in patients receiving ritonavir therapy, including those who developed hypertriglyceridemia.
Slovenian: Pri nekaterih bolnikih, zdravljenih z ritonavirjem, vključno s tistimi, ki so doživeli hipertrigliceridemijo, se je pojavil pankreatitis.
English: Concomitant use of sildenafil with ritonavir is contraindicated in pulmonary arterial hypertension patients (see section 4.3).
Slovenian: Sočasna uporaba sildenafila in ritonavirja je kontraindicirana pri bolnikih s pljučno arterijsko hipertenzijo (glejte poglavje 4.3).
English: ND ND
Slovenian: ND
English: Concomitant administration of glecaprevir/pibrentasvir and ritonavir is not recommended due to an increased risk of ALT elevations associated with increased glecaprevir exposure.
Slovenian: Sočasna uporaba glekaprevirja/pibrentasvirja in ritonavirja ni priporočljiva zaradi povečanega tveganja za povišanje alanin transaminaze (ALT), povezanega s povečano izpostavljenostjo glekaprevirju.
English: Doses of ritonavir less than 200 mg twice daily should not be used with tipranavir as they might alter the efficacy of the combination.
Slovenian: S tipranavirjem ne smete uporabljati odmerkov ritonavirja, manjših od 200 mg dvakrat na dan, ker lahko spremenijo učinkovitost kombinacije.
English: Thereby, increasing the risk of serious respiratory depression or haematologic abnormalities, or other serious adverse effects from these agents.
Slovenian: S tem se poveča tveganje za resno respiratorno depresijo, hematološke nepravilnosti ali druge resne neželene učinke teh zdravil.
English: Ritonavir dosed as an antiretroviral agent is likely to inhibit CYP2D6 and as a result is expected to increase concentrations of imipramine, amitriptyline, nortriptyline, fluoxetine, paroxetine or sertraline.
Slovenian: Ritonavir, odmerjan kot protiretrovirusno zdravilo, verjetno zavira CYP2D6, zato je treba pričakovati, da zviša koncentracijo imipramina, amitriptilina, nortriptilina, fluoksetina, paroksetina in sertralina.
English: It is important that Ritonavir Mylan tablets are swallowed whole and not chewed, broken or crushed.
Slovenian: Pomembno je, da filmsko obložene tablete Ritonavir Mylan pogoltnete cele in jih ne žvečite, prelomite ali zdrobite.
English: Concomitant use of neratinib with ritonavir is contraindicated due to serious and/or life threatening potential reactions including hepatotoxicity (see section 4.3).
Slovenian: Sočasna uporaba neratiniba in ritonavirja je kontraindicirana zaradi možnih resnih in/ali življenje ogrožajočih reakcij, vključno s hepatotoksičnostjo (glejte poglavje 4.3).
English: If the benefit outweighs the risk, co-administration of bedaquiline with ritonavir must be done with caution.
Slovenian: Če je korist večja od tveganja je pri sočasni uporabi bedakilina z ritonavirjem potrebna previdnost.
English: 100q12h↑ 57% ↑ 77%
Slovenian: 100 na 12 ur ↑ 57%
English: A case of renal failure with eosinophilia has been reported.
Slovenian: Opisan je primer ledvične odpovedi z eozinofilijo.
English: Adverse reactions from clinical trials and post-marketing experience in adult patients The most frequently reported adverse drug reactions among patients receiving ritonavir alone or in combination with other antiretroviral drugs were gastrointestinal (including diarrhoea, nausea, vomiting, abdominal pain (upper and lower)), neurological disturbances (including paraesthesia and oral paraesthesia) and fatigue/asthenia.
Slovenian: Najpogostejši neželeni učinki pri bolnikih, ki so prejemali samo ritonavir ali le-tega v kombinaciji z drugimi protivirusnimi zdravili, so bili gastrointestinalne motnje (vključno z diarejo, navzejo, bruhanjem, bolečinami v trebuhu (v spodnjem in zgornjem predelu)), nevrološke motnje (vključno s parestezijo in parestezijo okrog ust) in utrujenost/astenija.
English: 16 q24 h
Slovenian: 16 na 24 ur
English: Acute renal failure
Slovenian: občasni akutna odpoved ledvic
English: The dose of ritonavir may need adjusting.
Slovenian: Potrebna utegne biti prilagoditev odmerka ritonavirja.
English: EU/1/17/1242/001 EU/1/17/1242/002 EU/1/17/1242/003 EU/1/17/1242/004
Slovenian: EU/1/17/1242/004
English: For further dosage recommendations, refer to the product information of other Protease Inhibitors approved for co-administration with ritonavir.
Slovenian: Za nadaljnja priporočila o odmerjanju glejte navodilo za uporabo drugega zaviralca proteaz, odobrenega za sočasno uporabo z ritonavirjem.
English: Increased urination, renal impairment (e.g. oliguria, elevated creatinine)
Slovenian: Bolezni sečil pogosti povečano uriniranje, okvara ledvic (oligurija, zvišanje kreatinina)
English: Ritonavir dosed as an antiretroviral agent is likely to inhibit CYP2D6 and as a result is expected to increase concentrations of amphetamine and its derivatives.
Slovenian: Ritonavir, odmerjan kot protiretrovirusno zdravilo, verjetno zavira CYP2D6, zato je treba pričakovati, da zviša koncentracijo amfetamina in njegovih derivatov.
English: If you forget to take Ritonavir Mylan
Slovenian: Če ste pozabili vzeti zdravilo Ritonavir Mylan
English: If you stop taking Ritonavir Mylan
Slovenian: Če ste prenehali jemati zdravilo Ritonavir Mylan
English: Each film-coated tablet contains 87.75 mg of sodium.
Slovenian: Pomožna snov z znanim učinkom Ena filmsko obložena tableta vsebuje 87,75 mg natrija.
English: Trazodone is a CYP3A4 substrate and co-administration of ritonavir is expected to increase trazodone levels.
Slovenian: Trazodon je substrat CYP3A4 in pričakovati je, da sočasna uporaba ritonavirja zviša koncentracijo trazodona.
English: In a study completed in 2000, 76 HIV-1 infected children aged 6 months to 12 years who were protease inhibitor naive and naive to lamivudine and/or stavudine received ritonavir 350 or 450 mg/m2 every 12 hours co-administered with lamivudine and stavudine.
Slovenian: V študiji, dokončani leta 2000, je 76 s HIV-1 okuženih otrok, starih od 6 mesecev do 12 let, ki pred tem še niso dobivali zaviralcev proteaz, lamivudina in/ali stavudina, dobivalo ritonavir od 350 do 450 mg/m2