FrancophonIA/ELRC3.0 huggingface dataset:
English: Infants should be monitored closely for toxicity related to Kaletra oral solution including: hyperosmolality, with or without lactic acidosis, renal toxicity, central nervous system (CNS) depression (including stupor, coma, and apnea), seizures, hypotonia, cardiac arrhythmias and ECG changes, and hemolysis.
Slovenian: Dojenčke je treba skrbno spremljati glede toksičnosti zdravila Kaletra peroralna raztopina, vključno s hiperosmolalnostjo (z laktacidozo ali brez nje), nefrotoksičnostjo, depresijo osrednjega živčevja (OŽ) (vključno s stuporjem, komo in apnejo), konvulzijami, hipotonijo, motnjami srčnega ritma in spremembami EKG ter hemolizo.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Slovenian: Bolnike s kroničnim hepatitisom B ali C, ki dobivajo kombinirano protiretrovirusno zdravljenje, bolj ogrožajo hudi in potencialno usodni neželeni učinki na jetrih.
English: Kaletra contains sodium as saccharin sodium, sodium chloride and sodium citrate, which may be harmful to people on a low sodium diet.
Slovenian: Zdravilo Kaletra vsebuje natrij v obliki natrijevega saharinata, natrijevega klorida in natrijevega citrata, kar lahko škoduje ljudem na dieti z malo natrija.
English: Through 360 weeks of treatment, genotypic analysis of viral isolates was successfully conducted in 19 of 28 patients with confirmed HIV RNA above 400 copies/ml revealed no primary or active site mutations in protease (amino acids at positions 8, 30, 32, 46, 47, 48, 50, 82, 84 and 90) or protease inhibitor phenotypic resistance.
Slovenian: Med 360 tedni zdravljenja je bila genotipska analiza virusnih izolatov uspešno izvedena pri 19 od 28 bolnikih s potrjenim HIV RNA nad 400 kopij/ml in ni pokazala nobenih primarnih mutacij ali mutacij aktivnega mesta v proteazi (aminokisline na položajih 8, 30, 32, 46, 47, 48, 50, 82, 84 in 90) ali fenotipske odpornosti proti zaviralcem proteaze.
English: • Symptoms of dizziness, lightheadedness, fainting or sensation of abnormal heartbeats.
Slovenian: - Simptomi omotičnosti, vrtoglavice, omedlevice ali občutek nepravilnosti srčnega ritma.
English: Immunosuppressants Cyclosporin, Sirolimus (rapamycin), and Tacrolimus
Slovenian: Imunosupresivi Ciklosporin, sirolimus (rapamicin) in takrolimus
English: In use storage: If kept outside of the refrigerator, do not store above 25°C and discard any unused contents after 42 days (6 weeks).
Slovenian: Shranjevanje med uporabo: Če zdravila ne hranite v hladilniku, ga shranjujte na temperaturi do 25 °C, vso neporabljeno količino pa zavrzite po 42 dneh (6 tednih).
English: 2nd Trimester n = 17*
Slovenian: 2. trimesečje n = 17*
English: You should tell your doctor promptly about these or any other symptoms.
Slovenian: Zdravnika takoj obvestite o neželenih učinkih ali katerih koli drugih simptomih.
English: The in vitro antiviral activity of lopinavir against laboratory and clinical HIV strains was evaluated in acutely infected lymphoblastic cell lines and peripheral blood lymphocytes, respectively.
Slovenian: Protivirusno delovanje lopinavirja proti laboratorijskim in kliničnim sevom HIV so in vitro ocenili pri akutno okuženih limfoblastnih celičnih linijah (laboratorijski sevi) in limfocitih periferne krvi (klinični sevi).
English: Patients without prior antiretroviral therapy
Slovenian: Bolniki brez predhodnega protiretrovirusnega zdravljenja
English: Monitor for ADRs related to afatinib.
Slovenian: Spremljajte neželene učinke, ki so povezani z afatinibom.
English: If treatment with a HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended (see section 4.5).
Slovenian: Če je indicirano zdravljenje z zaviralcem reduktaze HMG-CoA, sta priporočljiva pravastatin ali fluvastatin (glejte poglavje 4.5).
English: Elevated transaminases with or without elevated bilirubin levels have been reported in HIV-1 mono-infected and in individuals treated for post-exposure prophylaxis as early as 7 days after the initiation of lopinavir/ritonavir in conjunction with other antiretroviral agents.
Slovenian: Poročali so o zvišanih koncentracijah transaminaz z ali brez zvišanja koncentracije bilirubina v plazmi pri bolnikih, okuženih s HIV, in pri posameznikih, zdravljenih po izpostavljenosti okužbi kot profilaksa, že 7 dni po začetku zdravljenja z lopinavirjem/ritonavirjem v kombinaciji z drugimi protivirusnimi zdravili.
English: 2 tablets (200/50 mg)
Slovenian: 2 tableti (200/50 mg)
English: If you or your child forget to take Kaletra
Slovenian: Če ste vi ali vaš otrok pozabili vzeti zdravilo Kaletra
English: The mean changes from baseline in PR interval ranged from 11.6 ms to 24.4 ms in the 12 hour interval post dose.
Slovenian: Povprečna sprememba dolžine intervala PR v primerjavi z izhodiščem je bila med 12-urnim obdobjem po odmerku od 11,6 ms do 24,4 ms. Najdaljši interval PR je bil 286 msec,
English: The steady state pharmacokinetic parameters of lopinavir in HIV-infected patients with mild to moderate hepatic impairment were compared with those of HIV-infected patients with normal hepatic function in a multiple dose study with lopinavir/ritonavir 400/100 mg twice daily.
Slovenian: Farmakokinetične parametre lopinavirja v stanju dinamičnega ravnovesja pri s HIV okuženih bolnikih z blago do zmerno jetrno okvaro so primerjali s tistimi pri s HIV okuženih bolnikih z normalno jetrno funkcijo v študiji z večkratnimi odmerki lopinavirja/ritonavirja 400/100 mg dvakrat dnevno.
English: Most tyrosine kinase inhibitors such as dasatinib and nilotinib, also vincristine and vinblastine: Risk of increased adverse events due to higher serum concentrations because of CYP3A4 inhibition by lopinavir/ritonavir.
Slovenian: Večina zaviralcev tirozin kinaz kot sta dasatinib in nilotinib, tudi vinkristin in vinblastin: tveganje za porast neželenih učinkov zaradi večjih koncentracij v serumu, ki jih povzroči zavrtje CYP3A z lopinavirjem/ritonavirjem.
English: Dosage recommendation for paediatric patients aged from 14 days to 6 months
Slovenian: Priporočila za odmerjanje pri pediatričnih bolnikih, starih od 14 dni do 6 mesecev Smernice za pediatrično odmerjanje od 2 tednov do 6 mesecev
English: • Tell your doctor immediately if you are planning to have a baby, you are pregnant, think you may be pregnant or if you are breast-feeding.
Slovenian: Nosečnost in dojenje - Zdravniku takoj povejte, če nameravate zanositi, če ste ali če mislite, da bi lahko bili noseči, ali če dojite.
English: The in vitro antiviral activity of lopinavir against 112 clinical isolates taken from patients failing therapy with one or more protease inhibitors was assessed.
Slovenian: In vitro so ocenili protivirusno dejavnost lopinavirja proti 112 kliničnim izolatom, vzetih bolnikom, pri katerih zdravljenje z enim ali več zaviralci proteaz ni bilo uspešno.
English: A 14C-lopinavir study in humans showed that 89% of the plasma radioactivity after a single 400/100 mg Kaletra dose was due to parent active substance.
Slovenian: Študija s 14C-lopinavirjem pri ljudeh je pokazala, da gre 89% radioaktivnosti v plazmi po enkratnem odmerku 400/100 mg zdravila Kaletra na račun matične zdravilne učinkovine.
English: In clinical studies with a limited number of isolates analysed, the selection of resistance to lopinavir has not been observed in naïve patients without significant protease inhibitor resistance at baseline.
Slovenian: V kliničnih študijah z omejenim številom analiziranih izolatov niso opazili selekcije odpornosti proti lopinavirju pri naivnih bolnikih brez pomembne odpornosti proti zaviralcem proteaz ob začetku zdravljenja.
English: In another open-label pharmacokinetic study, 19 HIV-infected pregnant women received lopinavir/ritonavir 400/100 mg twice daily as part of combination antiretroviral therapy during pregnancy from before conception.
Slovenian: V drugi odprti farmakokinetični študiji je 19 nosečnic, okuženih s HIV, prejemalo lopinavir/ritonavir 400/100 mg dvakrat dnevno kot del kombinirane protivirusne terapije med nosečnostjo, z začetkom že pred oploditvijo.
English: • Kaletra should always be taken every day to help control your HIV infection, no matter how much better you feel.
Slovenian: - Da bo zdravilo Kaletra pomagalo obvladovati okužbo s HIV, jo morate vzeti vsak dan, ne glede na to, koliko bolje se počutite.
English: 96 week arm (N=13)
Slovenian: Skupina s 96-tedenskim zdravljenjem (N=13)
English: (inhibition of CYP3A enzymes)
Slovenian: (zavrtje encimov CYP3A)
English: Apalutamide is a moderate to strong CYP3A4 inducer and this may lead to a decreased exposure of lopinavir/ritonavir.
Slovenian: Apalutamid je zmeren do močen induktor CYP3A4, kar lahko vodi v zmanjšanje izpostavljenosti lopinavirju/ritonavirju.
English: Kaletra is likely to increase plasma concentrations of medicinal products that are primarily metabolised by CYP3A.
Slovenian: Zdravilo Kaletra pogosto zveča plazemsko koncentracijo zdravil, ki se v prvi vrsti presnavljajo s CYP3A.
English: In rats, embryofoetotoxicity (pregnancy loss, decreased foetal viability, decreased foetal body weights, increased frequency of skeletal variations) and postnatal developmental toxicity (decreased survival of pups) was observed at maternally toxic dosages.
Slovenian: Med uporabo odmerkov, toksičnih za mater, so pri podganah opažali embriofetotoksičnost (izgubo brejosti, manjšo viabilnost plodov, manjšo telesno maso plodov, pogostejše skeletne spremembe) in postnatalno razvojno toksičnost (manjše preživetje mladičev).
English: Kaletra soft capsules and liquid have been shown to be bioequivalent under nonfasting conditions (moderate fat meal).
Slovenian: Dokazano je, da so mehke kapsule zdravila Kaletra in raztopina zdravila Kaletra v neteščih pogojih (zmerno masten obrok) bioekvivalentne.
English: If the co-administration of Kaletra with bupropion is judged unavoidable, this should be done under close clinical monitoring for bupropion efficacy, without exceeding the recommended dosage, despite the observed induction.
Slovenian: Če se sočasni uporabi zdravila Kaletra in bupropiona ni mogoče izogniti, je treba med hkratno uporabo teh zdravil natančno klinično spremljati učinkovitost bupropiona; priporočenega odmerka se kljub opaženi indukciji ne sme preseči.
English: However, such a dose adjustment might be associated with ALT/AST elevations and with increase in gastrointestinal disorders.
Slovenian: Toda takšno prilagoditev odmerka lahko spremlja zvišanje ALT/AST in več prebavnih motenj.
English: Carbamazepine and Phenobarbital
Slovenian: Karbamazepin in fenobarbital
English: The syringe has two main parts, a ‘plunger' and a ‘barrel'.
Slovenian: Brizga ima dva bistvena dela: bat in cev.
English: Bepridil, Systemic Lidocaine, Quinidine:
Slovenian: Bepridil, sistemski lidokain in kinidin:
English: There is no specific antidote for overdose with Kaletra.
Slovenian: Za preveliko odmerjanje zdravila Kaletra ni specifičnega antidota.
English: • medicines used to treat asthma and other lung-related problems such as chronic obstructive pulmonary disease (COPD) (e.g. salmeterol);
Slovenian: - zdravila za zdravljenje astme in drugih pljučnih bolezni, npr. kronične obstruktivne pljučne bolezni (KOPB) (npr. salmeterol);
English: If a patient is already taking St John's wort, stop St John's wort and if possible check viral levels.
Slovenian: Če bolnik že jemlje šentjanževko, jo mora nehati jemati in kontrolirati mu je treba raven virusov, če je mogoče.
English: (Lopinavir/ritonavir 533/133 mg BID)
Slovenian: (Lopinavir/ritonavir 533/133 mg dvakrat na dan)
English: • The usual adult dose is 5 ml of the oral solution twice a day i.e. every 12 hours, in combination with other anti-HIV medicines.
Slovenian: - Običajni odmerek je 5 ml peroralne raztopine dvakrat na dan (tj. vsakih 12 ur) v kombinaciji z drugimi zdravili proti HIV.
English: • levothyroxine (used to treat thyroid problems);
Slovenian: - levotiroksin (za zdravljenje težav s ščitnico);
English: • non-nucleoside reverse transcriptase inhibitors (NNRTIs) (e.g. efavirenz, nevirapine);
Slovenian: - nenukleozidni zaviralci reverzne transkriptaze (NNRTI - Non-nucleoside reverse transcriptase inhibitors) (npr. efavirenz, nevirapin);
English: The 230/57.5 mg/m2 dosage might be insufficient in some children when co-administered with nevirapine or efavirenz.
Slovenian: Sočasno zdravljenje z efavirenzom ali nevirapinom Odmerjanje 230/57,5 mg/m2 utegne biti pri nekaterih otrocih nezadostno, če sta sočasno uporabljena nevirapin ali efavirenz.
English: Methadone: ↓
Slovenian: Metadon: ↓
English: • Kaletra should always be taken twice every day to help control your HIV infection, no matter how much better you feel.
Slovenian: - Da bo zdravilo Kaletra pomagala obvladovati okužbo s HIV, jo morate vzeti vsak dan dvakrat, ne glede na to, koliko bolje se počutite.
English: How to take Kaletra
Slovenian: Kako jemati zdravilo Kaletra
English: Other medicines and Kaletra
Slovenian: Druga zdravila in zdravilo Kaletra
English: Body weight (kg) Twice daily oral solution dose (dose in mg/kg)
Slovenian: Telesna masa (kg) Odmerek peroralne raztopine dvakrat na dan (odmerek v mg/kg)
English: It may be difficult to tell which side effects have been caused by Kaletra and which may occur due to other medicines you take at the same time or by the complications of the HIV infection.
Slovenian: Včasih je težko ločiti neželene učinke zaradi zdravila Kaletra od neželenih učinkov zaradi drugih sočasno uporabljanih zdravil ali od zapletov okužbe HIV.
English: Postmarketing life-threatening cases of cardiac toxicity (including complete atrioventricular (AV) block, bradycardia, and cardiomyopathy), lactic acidosis, acute renal failure, CNS depression and respiratory complications leading to death have been reported, predominantly in preterm neonates receiving Kaletra oral solution (see sections 4.3 and 4.9).
Slovenian: Med obdobjem trženja so bili opisani smrtno nevarni primeri kardiotoksičnosti (vključno s popolnim atrioventrikularnim (AV) blokom, bradikardijo in kardiomiopatijo), laktacidoze, akutne odpovedi ledvic, depresije OŽ in dihalnih zapletov, ki so povzročili smrt, predvsem pri nedonošenih novorojenčkih, ki so prejemali zdravilo Kaletra peroralna raztopina (glejte poglavji 4.3 in 4.9).
English: Undesirable effects in clinical studies and post-marketing in adult patients System organ class
Slovenian: Neželeni učinki v kliničnih študijah in iz obdobja trženja zdravila pri odraslih bolnikih
English: − This medicine has been prescribed for you or your child only.
Slovenian: - Zdravilo je bilo predpisano vam osebno ali vašemu otroku in ga ne smete dajati drugim.
English: • If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom) as Kaletra may reduce the effectiveness of oral and patch contraceptives.
Slovenian: - Če za preprečevanje nosečnosti jemljete peroralne kontraceptive ali kontraceptive v obližu, morate uporabiti dodatno ali drugačno kontracepcijsko zaščito (npr. kondom), kajti zdravilo Kaletra lahko zmanjša učinkovitost peroralnih kontraceptivov ali kontraceptivov v obližu.
English: Ranitidine (150 mg single dose)
Slovenian: Ranitidin (enkratni odmerek 150 mg)
English: For Kaletra oral solution, the corresponding increases in lopinavir AUC and Cmax were 80% and 54%, respectively.
Slovenian: Pri peroralni raztopini Kaletra je bilo ustrezno zvečanje AUC lopinavirja 80 %, Cmax pa 54 %.
English: nevirapine
Slovenian: nevirapin
English: Co-administration of rivaroxaban and Kaletra may increase rivaroxaban exposure which may increase the risk of bleeding.
Slovenian: Sočasna uporaba rivaroksabana in zdravila Kaletra lahko poveča izpostavljenost rivaroksabanu, kar lahko poveča tveganje za krvavitev.
English: • products that contain St John's wort (Hypericum perforatum).
Slovenian: - izdelke, ki vsebujejo šentjanževko (Hypericum perforatum).
English: Therefore, if co-administration of delamanid with lopinavir/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 SmPC).
Slovenian: Zato se v primeru, če se sočasno dajanje delamanida z lopinavirjem/ritonavirjem smatra za potrebno, skozi celotno obdobje zdravljenja z delamanidom priporoča zelo pogosto spremljanje EKG-ja (glejte poglavje 4.5 in glejte povzetek glavnih značilnosti zdravila za delamanid).
English: Adult patients who have not previously taken other antiviral medicines can also take Kaletra tablets once daily as an 800 mg/200 mg dose.
Slovenian: Odrasli bolniki, ki predhodno še niso dobivali drugih protiretrovirusnih zdravil, lahko tablete zdravila Kaletra jemljejo tudi enkrat na dan v odmerku 800 mg/200 mg.
English: • amiodarone, dronedarone (used to treat abnormal heart beat);
Slovenian: - amiodaron, dronedaron (uporablja se za zdravljenje motenj srčnega ritma);
English: Rifampicin in combination with Kaletra causes large decreases in lopinavir concentrations which may in turn significantly decrease the lopinavir therapeutic effect.
Slovenian: Rifampicin v kombinaciji z zdravilom Kaletra povzroči veliko znižanje koncentracij lopinavirja s posledičnim pomembnim zmanjšanjem terapevtskega učinka lopinavirja.
English: However, if it is judged necessary to resort to solid oral dosage form for children weighing less than 40 kg or with a BSA between 0.5 and 1.4 m2 and able to swallow tablets, Kaletra 100 mg/25 mg tablets may be used.
Slovenian: Če pa je treba uporabiti trdno peroralno odmerno obliko za otroke s telesno maso manj kot 40 kg ali s telesno površino od 0,5 do 1,4 m2, ki zmorejo zaužiti tablete, je mogoče uporabiti tablete zdravila Kaletra 100 mg/25 mg.
English: People taking Kaletra may still develop infections or other illnesses associated with HIV disease and AIDS.
Slovenian: Osebe, ki jemljejo zdravilo Kaletra, lahko še vedno zbolijo za okužbami ali drugimi boleznimi, povezanimi z boleznijo HIV in aidsom.
English: adverse events, including renal disorders.
Slovenian: vključno s konvulzivnimi napadi.
English: M06-802 was a randomised open-label study comparing the safety, tolerability and antiviral activity of once-daily and twice-daily dosing of lopinavir/ritonavir tablets in 599 subjects with detectable viral loads while receiving their current antiviral therapy.
Slovenian: M06-802 je bila randomizirana, odprta študija, ki je primerjala varnost, prenašanje in protivirusno delovanje tablet lopinavirja/ritonavirja enkrat in dvakrat na dan pri 599 preiskovancih z ugotovljivim virusnim bremenom med njihovim trenutnim protivirusnim zdravljenjem.
English: • In use storage: If kept outside of the refrigerator, do not store above 25°C and discard any unused contents after 42 days (6 weeks).
Slovenian: - Shranjevanje med uporabo: Če zdravila ne hranite v hladilniku, ga shranjujte pri temperaturi do 25°C, vso neporabljeno količino pa zavrzite po 42 dneh (6 tednih).
English: * Kaletra tablets must not be chewed, broken or crushed.
Slovenian: * Tablet zdravila Kaletra se ne sme žvečiti, lomiti ali drobiti.
English: Phosphodiesterase(PDE5) inhibitors Avanafil (ritonavir 600 mg BID)
Slovenian: Zaviralci fosfodiesteraze (PDE5) Avanafil (ritonavir 600 mg 2x dnevno)
English: The mean steady-state trough concentration prior to the morning dose was 5.5 ± 5.4 µg/ml.
Slovenian: Povprečna najmanjša koncentracija v stanju dinamičnega ravnovesja pred jutranjim odmerkom je bila 5,5 ± 5,4 µg/ml.
English: One hundred patients were originally treated with Kaletra in the study (including 51 patients receiving 400/100 mg twice daily and 49 patients at either 200/100 mg twice daily or 400/200 mg twice daily).
Slovenian: Uvodoma je zdravilo Kaletra v študiji dobivalo 100 bolnikov (51 bolnikov je dobivalo odmerek 400/100 mg dvakrat na dan, 49 bolnikov pa bodisi 200/100 mg dvakrat na dan ali 400/200 mg dvakrat na dan).
English: Herbal preparations containing St John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of lopinavir and ritonavir (see section 4.5).
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum)) zaradi tveganja za znižanje plazemske koncentracije in zmanjšanje kliničnih učinkov lopinavirja in ritonavirja (glejte poglavje 4.5).
English: In the absence and presence of 50% human serum, the mean IC50 of lopinavir against HIV-1IIIB in MT4 cells was 17 nM and 102 nM, respectively.
Slovenian: V odsotnosti oz. prisotnosti 50 % človeškega seruma je bila povprečna IC50 lopinavirja proti HIV-1IIIB v celicah MT4 17 nM oz. 102 nM.
English: Kaletra must not be given to these patients (see section 4.3).
Slovenian: Ti bolniki ne smejo prejeti zdravila Kaletra (glejte poglavje 4.3).
English: Kaletra should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life threatening events.
Slovenian: Zato se je ne sme uporabljati sočasno z zdravili, katerih očistek je močno odvisen od CYP3A in pri katerih je zvečana koncentracija v plazmi povezana z resnimi in/ali smrtno nevarnimi učinki.
English: Once-daily dosing: the pharmacokinetics of once daily Kaletra have been evaluated in HIV-infected subjects naïve to antiretroviral treatment.
Slovenian: Odmerjanje enkrat na dan: Farmakokinetiko zdravila Kaletra enkrat na dan so ocenili pri preiskovancih, okuženih s HIV, ki še niso dobivali protiretrovirusnega zdravljenja.
English: Microsomal triglyceride transfer protein (MTTP) inhibitor
Slovenian: Zaviralci mikrosomskega transportnega proteina trigliceridov (MTTP)
English: Rifabutin, 150 mg QD Rifabutin (parent drug and active 25-O-desacetyl metabolite):
Slovenian: Rifabutin (matično zdravilo in aktivni 25-O-dezacetilni presnovek):
English: Lopinavir AUC over a 24 hour dosing interval averaged 206.5 ± 89.7 µg•h/ml.
Slovenian: AUC lopinavirja med 24-urnim odmernim intervalom je bila v povprečju 206,5 ± 89,7 µg·h/ml.
English: Along with nucleoside reverse transcriptase inhibitors (NRTIs), in some studies, Kaletra was used in combination with efavirenz or nevirapine.
Slovenian: V nekaterih študijah so skupaj z nukleozidnimi zaviralci reverzne transkriptaze (NRTI) uporabili zdravilo Kaletra v kombinaciji z efavirenzem ali nevirapinom.
English: Children less than 14 days of age and premature neonates Kaletra oral solution should not be administered to neonates before a postmenstrual age (first day of the mother's last menstrual period to birth plus the time elapsed after birth) of 42 weeks and a postnatal age of at least 14 days has been reached (see section 4.4).
Slovenian: (obdobje od prvega dneva zadnjega menstrualnega cikla matere do rojstva ter čas po rojstvu) 42 tednov in postnatalne starosti vsaj 14 dni (glejte poglavje 4.4).
English: Furthermore, rare increases in PR interval have been reported during Kaletra therapy (see section 4.4).
Slovenian: Poleg tega so med zdravljenjem z zdravilom Kaletra opisani redki primeri podaljšanja intervala PR (glejte poglavje 4.4).
English: Patients should be informed that nausea has been reported during treatment with Kaletra (see section 4.8).
Slovenian: Bolnikom morate povedati, da so poročali o navzeji med zdravljenjem z zdravilom Kaletra (glejte poglavje 4.8).
English: Using the 5 ml oral dosing syringe for doses more than 2 ml
Slovenian: Uporaba 5 ml brizge za peroralno dajanje za odmerke, večje od 2 ml
English: Each 1 ml contains 356.3 mg of alcohol (42.4% v/v), 168.6 mg of high fructose corn syrup, 152.7 mg of propylene glycol (15.3% w/v) (see section 4.3), 10.2 mg of polyoxyl 40 hydrogenated castor oil and 4.1 mg of acesulfame potassium (see section 4.4).
Slovenian: En ml raztopine vsebuje 356,3 mg alkohola (42,4 % v/v), 168,6 mg koruznega sirupa z visoko vsebnostjo fruktoze, 152,7 mg propilenglikola (15,3 % m/v) (glejte poglavje 4.3), 10,2 mg makrogolglicerol 40 hidrogeniranega ricinusovega olja in 4,1 mg kalijevega acesulfamata (glejte poglavje 4.4).