FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, patients on stable dose of paroxetine who start treatment with Agenerase and ritonavir should be monitored for antidepressant response.
Slovenian: Poleg tega je treba pri bolnikih, ki dobivajo stabilen odmerek paroksetina in začnejo zdravljenje z zdravilom Agenerase in ritonavirjem, kontrolirati antidepresivni odziv.
English: The plasma amprenavir half-life is increased when Agenerase capsules are co-administered with ritonavir.
Slovenian: Plazemski razpolovni čas amprenavirja se poveča, če se kapsule Agenerase dajejo sočasno z ritonavirjem.
English: Efavirenz: efavirenz has been seen to decrease the Cmax, AUC and Cmin,ss of amprenavir by approximately 40 % in adults.
Slovenian: Efavirenz: Pri odraslih je bilo opaženo, da efavirenz zmanjša Cmax, AUC in Cmin,ss amprenavirja za približno 40 %.
English: Nevirapine: The effect of nevirapine on other protease inhibitors and the limited evidence available suggest that nevirapine may decrease the serum concentrations of amprenavir.
Slovenian: Nevirapin: Učinek nevirapina na druge zaviralce proteaz in omejenost razpoložljivih dokazov dopuščata možnost, da lahko nevirapin zniža serumsko koncentracijo amprenavirja.
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Slovenian: Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - "combination antiretroviral therapy") nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične patogene in povzroči resna klinična stanja ali poslabšanje simptomov.
English: Erythromycin: no pharmacokinetic study has been performed with Agenerase in combination with erythromycin, however, plasma levels of both medicinal products may be increased when co-administered.
Slovenian: Eritromicin: Farmakokinetične študije o uporabi zdravila Agenerase v kombinaciji z eritromicinom niso bile izvedene, vendar lahko pride ob sočasni uporabi do porasta plazemskih koncentracij obeh zdravil.
English: You should stop taking Agenerase oral solution as soon as you are able to swallow the Agenerase capsules.
Slovenian: Peroralno raztopino Agenerase morate prenehati jemati takoj, ko lahko pogoltnete kapsule Agenerase.
English: When amprenavir is administered as monotherapy, resistant viruses rapidly emerge (see section 5.1).
Slovenian: V primeru monoterapije z amprenavirjem se hitro pojavijo rezistentni virusi (glejte poglavje 5.1).
English: Hepatic impairment: the principal route of metabolism of amprenavir is via the liver.
Slovenian: Oslabljeno delovanje jeter: Glavna pot presnove amprenavirja poteka preko jeter.
English: Propylene glycol can cause a range of adverse effects including seizures, stupor, rapid heart beat and the breakdown of red blood cells (see also Do not take Agenerase, Take special care with Agenerase).
Slovenian: Propilenglikol lahko povzroči vrsto neželenih učinkov, vključno z epileptičnimi napadi, s stuporjem (nezavestjo), hitrejšim bitjem srca in z razgradnjo rdečih krvničk (glejte tudi Ne jemljite zdravila Agenerase, Previdnost in posebna opozorila pri uporabi).
English: Concomitant low dose ritonavir was not administered and the majority of the PI experienced subjects had prior exposure to at least one (78 %) or two (42 %) of the NRTIs co-administered with Agenerase.
Slovenian: Večina otrok, ki se je že zdravila s PI-ji, je bila predhodno, sočasno z zdravilom Agenerase, izpostavljena vsaj še enemu (78 %) ali dvema (42 %) NRTI-jema.
English: Midazolam: midazolam is extensively metabolized by CYP3A4.
Slovenian: Midazolam: midazolam se intenzivno presnavlja preko CYP3A4.
English: CYP2D6 substrates with narrow therapeutic index Agenerase with ritonavir must not be co-administered with medicinal products containing active substances that are highly dependent on CYP2D6 metabolism and for which elevated plasma concentrations are associated with serious and / or life-threatening adverse reactions.
Slovenian: Substrati za CYP2D6 z ozkim terapevtskim indeksom Zdravilo Agenerase v kombinaciji z ritonavirjem se ne sme dajati sočasno z zdravili, katerih učinkovine so močno odvisne od presnove s CYP2D6 in katerih povečane koncentracije v plazmi so povezane z resnimi in/ali smrtno nevarnimi neželenimi reakcijami.
English: - if you are currently taking any products containing St John's wort (Hypericum perforatum) as this may stop Agenerase from working properly (see Taking/using other medicines).
Slovenian: - če trenutno uporabljate kateri koli pripravek s šentjanževko (Hypericum perforatum), ker lahko sočasno jemanje prepreči pravilno delovanje zdravila Agenerase (glejte 'Jemanje/uporaba drugih zdravil').
English: At therapeutic dosages (1200 mg twice daily), the mean maximum steady state concentration (Cmax,ss) of amprenavir capsules is 5.36 μg/ml (0.92-9.81) and the minimum steady state concentration (Cmin,ss) is 0.28 μg/ml (0.12-0.51).
Slovenian: Pri terapevtskih odmerkih (1200 mg dvakrat dnevno) je srednja maksimalna koncentracija v stanju dinamičnega ravnovesja (Cmax,ss) amprenavirja, prejetega v obliki kapsul, znašala 5,36 µg/ml (0,929,81), minimalna koncentracija v stanju dinamičnega ravnovesja (Cmin,ss) pa 0,28 µg/ml (0,12-0,51).
English: Fluticasone propionate (interaction with ritonavir): in a clinical study where ritonavir 100 mg capsules bid were co-administered with 50 µg intranasal fluticasone propionate (4 times daily) for 7 days in healthy subjects, the fluticasone propionate plasma levels increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86 % (90 % confidence interval 82-89 %).
Slovenian: Flutikazonpropionat (interakcija z ritonavirjem): Pri zdravih osebah, ki so med klinično študijo 7 dni sočasno prejemale ritonavir v obliki 100 mg kapsul dvakrat dnevno in flutikazonpropionat v odmerku 50 µg intranazalno (4-krat dnevno) so ugotovili, da so se vrednosti flutikazonpropionata v plazmi znatno povečale, intrinzične vrednosti kortizola pa zmanjšale za približno 86 % (90 % interval zaupanja; 82-89 %).
English: Anticonvulsant active substances: concomitant administration of anticonvulsant active substances known as enzymatic inductors (phenytoin, phenobarbital, carbamazepine) with amprenavir may lead to a decrease in the plasma concentrations of amprenavir.
Slovenian: Antiepileptiki: Zaradi sočasne uporabe antiepileptikov, ki so znani induktorji encimov (fenitoin, fenobarbital, karbamazepin) skupaj z amprenavirjem se lahko zmanjšajo koncentracije amprenavirja v plazmi.
English: Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Slovenian: Kombinirano protiretrovirusno zdravljenje je bilo povezano s presnovnimi motnjami, kot so hipertrigliceridemija, hiperholesterolemija, insulinska rezistenca, hiperglikemija in hiperlaktatemija (glejte poglavje 4.4).
English: Other medicinal products, listed below, including examples of substrates, inhibitors or inducers of CYP3A4, may lead to interactions when administered with Agenerase.
Slovenian: Druga zdravila, navedena spodaj, so primeri substratov, zaviralcev ali induktorjev CYP3A4, s katerimi bi, v primeru sočasne uporabe z zdravilom Agenerase, lahko prišlo do interakcij.
English: On the basis of current pharmacodynamic data, amprenavir should be used in combination with at least two other antiretrovirals.
Slovenian: Na osnovi trenutno razpoložljivih farmakodinamičnih podatkov je potrebno amprenavir uporabljati v kombinaciji s še najmanj dvema drugima protiretrovirusnima zdraviloma.
English: Based on pharmacokinetic data, the dose of Agenerase capsules should be reduced to 450 mg twice a day for adult patients with moderate hepatic impairment and to 300 mg twice a day for adult patients with severe hepatic impairment.
Slovenian: Na osnovi farmakokinetičnih podatkov je potrebno pri odraslih bolnikih z zmerno oslabljenim delovanjem jeter odmerek kapsul Agenerase zmanjšati na 450 mg dvakrat dnevno, pri odraslih bolnikih s hudo oslabljenim delovanjem jeter pa na 300 mg dvakrat dnevno.
English: The studies evaluated Agenerase oral solution and capsules at doses of 15 mg/kg three times daily, 20 mg/kg three times daily, 20 mg/kg twice daily and 22.5 mg/kg twice daily although the majority received 20 mg/kg twice daily.
Slovenian: Študiji sta vrednotili uporabo zdravila Agenerase v obliki peroralne raztopine in v obliki kapsul v odmerkih 15 mg/kg trikrat na dan, 20 mg/kg trikrat na dan, 20 mg/kg dvakrat na dan in 22,5 mg/kg dvakrat na dan.
English: The increase in rifabutin plasma concentration is likely to result from inhibition of rifabutin CYP3A4 mediated metabolism by amprenavir.
Slovenian: Porast plazemske koncentracije rifabutina je verjetno posledica zaviranja presnove rifabutina na CYP3A4 s strani amprenavirja.
English: Based on historical comparison, amprenavir pharmacokinetic parameters were not altered by paroxetine.
Slovenian: Po retrospektivni primerjavi sodeč paroksetin ne spremeni farmakokinetičnih parametrov amprenavirja.
English: Therefore Agenerase should not be co-administered with orally administered midazolam (see section 4.3), whereas caution should be used with co-administration of Agenerase and parenteral midazolam.
Slovenian: Zaradi tega naj se zdravilo Agenerase ne daje sočasno s peroralno apliciranim midazolamom (glejte poglavje 4.3), ob sočasni parenteralni aplikaciji zdravila Agenerase in midazolama pa je potrebna previdnost.
English: Metronidazole: Agenerase oral solution is contraindicated in patients treated with metronidazole (see section 4.3).
Slovenian: Metronidazol: Peroralna raztopina Agenerase je kontraindicirana pri bolnikih, ki se zdravijo z metronidazolom (glejte poglavje 4.3).
English: Approximately 90 % of an orally administered radiolabelled amprenavir dose was recovered in the urine and the faeces, primarily as amprenavir metabolites.
Slovenian: Približno 90 % zaužitega, z radionuklidi označenega odmerka amprenavirja je bilo izoliranega iz urina in blata, zlasti v obliki presnovkov amprenavirja.
English: Oral anticoagulants: a reinforced monitoring of the International Normalised Ratio is recommended in case of administration of Agenerase with warfarin or other oral anticoagulants, due to a possible decrease or increase of their antithrombotic effect (see section 4.4).
Slovenian: Peroralni antitrombotiki: Priporočamo poostreno nadziranje internacionalnega normaliziranega razmerja, če se zdravilo Agenerase uporablja skupaj z varfarinom ali drugimi peroralnimi antitrombotiki, zaradi možnega zmanjšanja ali povečanja njihovega antitrombotičnega učinka (glejte poglavje 4.4).
English: The active substance is amprenavir
Slovenian: Zdravilna učinkovina je amprenavir.
English: The mutational profiles were similar to those described for PI-experienced adults treated with fosamprenavir / ritonavir.
Slovenian: Profili mutacij so bili podobni tistim pri odraslih, ki so se predhodno že zdravili z zaviralci proteaz in so se zdravili s fosamprenavirjem / ritonavirjem.
English: Serum levels of amprenavir can be reduced by concomitant use of the herbal preparation St John's wort (Hypericum perforatum).
Slovenian: Serumske koncentracije amprenavirja se lahko ob sočasni uporabi rastlinskih pripravkov iz šentjanževke (Hypericum perforatum) znižajo.
English: For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder.
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
English: Cross-Resistance
Slovenian: Navzkrižna rezistenca
English: If you stop taking Agenerase You must not stop taking Agenerase without consulting your doctor.
Slovenian: Če ste prenehali jemati zdravilo Agenerase Zdravila Agenerase ne smete prenehati jemati, ne da bi se o tem prej posvetovali s svojim zdravnikom.
English: Your doctor will normally direct that Agenerase capsules should be taken with low doses of ritonavir to boost its efficacy.
Slovenian: Praviloma vam bo vaš zdravnik pojasnil, da se morajo kapsule Agenerase jemati skupaj z nizkimi odmerki ritonavirja, ki okrepi učinek kapsul Agenerase.
English: One resistance mutation was observed in each of 3 isolates: K20K/R, I54I/L and I93I/L respectively.
Slovenian: Pri vsakem od 3 izolatov so poročali o eni rezistenčni mutaciji: K20K/R, I54I/L ali I93I/L.
English: If your doctor has recommended that you take Agenerase capsules together with low doses of ritonavir, used to boost its activity, then please make sure that you carefully read the ritonavir Package Leaflet before starting therapy.
Slovenian: Če vam je zdravnik priporočil jemati kapsule Agenerase skupaj z nizkimi odmerki ritonavirja, kar okrepi učinkovanje kapsul Agenerase, bodite pozorni in pred pričetkom zdravljenja natančno preberite tudi ritonavirju priloženo navodilo za uporabo.
English: During attempts to overcome the decreased exposure by increasing the dose of other protease inhibitors with ritonavir, a high frequency of liver reactions was seen.
Slovenian: Ko so manjšo izpostavljenost poskušali nadomestiti z zvečanjem odmerka drugih zaviralcev proteaz v kombinaciji z ritonavirjem, so poročali o večji pogostnosti jetrnih neželenih učinkov.
English: Elevated transaminases and hyperbilirubinaemia (grade 3-4) were reported primarily in patients with abnormal values at baseline.
Slovenian: O zvišanih vrednostih transaminaz in hiperbilirubinemiji (stopnja 3-4) so poročali predvsem pri bolnikih z nenormalnimi osnovnimi vrednostmi.
English: Additionally, as no dosing recommendations can be made regarding the concomitant use of Agenerase oral solution and low dose ritonavir, the use of this combination must be avoided in these patient populations.
Slovenian: Ker za sočasno uporabo peroralne raztopine Agenerase in nizkega odmerka ritonavirja ne moremo podati priporočenih odmerkov, se je potrebno takšni kombinacije pri tej skupini bolnikov izogibati.
English: The pharmacokinetic interactions between amprenavir and low doses of ritonavir or other protease inhibitors have not yet been evaluated in children.
Slovenian: Farmakokinetične interakcije med amprenavirjem in nizkimi odmerki ritonavirja ali drugimi zaviralci proteaz pri otrocih še niso bile ovrednotene.
English: • Protease inhibitors (PIs):
Slovenian: • Zaviralci proteaz (PI-ji):
English: Events (grade 2-4) reported by study investigators as attributable to study medication and occurring in >1% of patients, are included as well as grade 3-4 treatment emergent laboratory abnormalities.
Slovenian: Vključeni so tako neželeni učinki (stopnje 2-4), ki so se pojavili pri > 1 % bolnikov in so jih raziskovalci, ki so o njih poročali, pripisali preučevanemu zdravilu, kot tudi laboratorijska odstopanja stopnje 3-4, ki so bila povezana z zdravljenjem.
English: Therefore, if paroxetine is co-administered with Agenerase and ritonavir, the recommended approach is a dose titration of paroxetine based on a clinical assessment of antidepressant response.
Slovenian: Če je torej paroksetin uporabljen sočasno z zdravilom Agenerase in ritonavirjem, je priporočljivo prilagoditi odmerek paroksetina na podlagi klinične ocene antidepresivnega odziva.
English: Patients taking the oral solution of Agenerase, particularly those with renal impairment or those with decreased ability to metabolise propylene glycol (e.g. those of Asian origin), should be monitored for adverse reactions potentially related to the high propylene glycol content (550 mg/ml), such as seizures, stupor, tachycardia, hyperosmolarity, lactic acidosis, renal toxicity, haemolysis.
Slovenian: Pri bolnikih, ki jemljejo peroralno raztopino Agenerase, še posebno pri tistih z oslabljenim delovanjem ledvic ali zmanjšano zmožnostjo presnove propilenglikola (npr. azijsko poreklo), je potrebno, zaradi velike vsebnosti propilenglikola (550 mg/ml) nadzirati možne, s tem povezane neželene učinke, kot so: epileptični napadi, stupor, tahikardija, hiperosmolarnost, laktacidoza, toksičnost za ledvice ali hemoliza.
English: However, significant liver toxicity has not been observed in patients treated in clinical studies, either during administration of Agenerase or after discontinuation.
Slovenian: Vendar pri bolnikih, ki so bili zdravljeni v kliničnih študijah, niso opazili znatnejše toksičnosti za jetra niti v času jemanja niti po prekinitvi zdravljenja z zdravilom Agenerase.
English: Analysis of the virological failure samples across these regimens defined four main resistance pathways: V32I+I47V, I50V, I54L/M and I84V.
Slovenian: Analize primerov virusnega neodziva v teh režimih so pokazale štiri glavne mehanizme odpornosti: V32I+I47V, I50V, I54L/M in I84V.
English: Local toxicity and sensitising potential was absent in animal studies, but slight irritating properties to the rabbit eye were identified.
Slovenian: V študijah na živalih ni bilo opaziti lokalne toksičnosti ali potenciala senzitacije, pokazala pa se je rahla iritativnost na očesu kunca.
English: If any of the side ffects gets serious, or you notice any effects not listed in this leaflet, please tell your doctor or pharmacist.
Slovenian: Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: If these medicinal products are used concomitantly care is advised, as delavirdine may be less effective due to decreased and potentially sub-therapeutic plasma concentrations.
Slovenian: Ob hkratni uporabi teh dveh zdravil svetujemo previdnost, saj je zaradi znižanih in potencialno subterapevtskih koncentracij delavirdina v plazmi njegova učinkovitost lahko zmanjšana.
English: It is recommended that antacids and Agenerase should be administered at least one hour apart.
Slovenian: Priporočljivo je, da se antacidi in zdravilo Agenerase uporabljajo vsaj z enournim presledkom.
English: • Glaxo Wellcome GmbH & Co. KG Industrie straße 32-36, 23843 Bad Oldesloe, Germany
Slovenian: Industrie straße 32-36, 23843 Bad Oldesloe, Nemčija
English: • Increases in blood sugar or cholesterol (a type of blood fat)
Slovenian: • Povečane vrednosti holesterola (vrsta maščobe v krvi).
English: The Cmax of amprenavir was decreased by 14 % whilst the AUC and Cmin were increased by 9 % and 189 %, respectively.
Slovenian: Cmax amprenavirja se je znižala za 14 %, medtem ko sta se AUC in Cmin amprenavirja zvečali, in sicer AUC za 9 % ter Cmin za 189 %.
English: Children less than 4 years of age: Agenerase is not recommended in children below 4 years due to lack of data on safety and efficacy (see section 5.2).
Slovenian: Otroci, mlajši od 4 let: Zaradi pomanjkanja podatkov o varnosti in učinkovitosti, uporabe zdravila Agenerase pri otrocih, mlajših od 4 let, ne priporočamo (glejte poglavje 5.2).
English: In patients with haemophilia Type A and B, there have been reports of increased bleeding while taking protease inhibitors.
Slovenian: Pri bolnikih s hemofilijo tipa A in B so poročali o pogostnejših krvavitvah v času jemanja zaviralcev proteaz.
English: Soft capsules
Slovenian: Mehke kapsule
English: Taking Agenerase with food and drink Agenerase oral solution can be taken with or without food.
Slovenian: Jemanje zdravila Agenerase skupaj s hrano in pijačo Peroralno raztopino Agenerase lahko jemljete skupaj s hrano ali brez nje.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse events.
Slovenian: Pri bolnikih s kroničnim hepatitisom B ali C, ki se zdravijo s kombiniranim protiretrovirusnim zdravljenjem, obstaja veliko tveganje za pojav hudih in potencialno usodnih jetrnih neželenih učinkov.
English: Agenerase may interact with certain other medicines.
Slovenian: Učinek zdravila Agenerase se lahko prepleta še z učinki nekaterih drugih zdravil.
English: The bioavailability of the oral solution at equivalent doses is lower than that of the capsules, with an AUC and Cmax approximately 14 % and 19 % lower, respectively (see section 4.2).
Slovenian: Biološka uporabnost peroralne raztopine je pri enakih odmerkih v primerjavi s kapsulami manjša, pri peroralni raztopini je AUC manjša za približno 14 %, Cmax pa za 19 % (glejte poglavje 4.2).
English: Cross resistance between amprenavir and reverse transcriptase inhibitors is unlikely to occur because the enzyme targets are different.
Slovenian: Malo je verjetno, da bi se med amprenavirjem in zaviralci reverzne transkriptaze pojavila navzkrižna rezistenca, saj so njihovi tarčni encimi različni.
English: This medicinal product contains 4 mg sodium per ml.
Slovenian: To zdravilo vsebuje 4 mg natrija na ml.
English: Do not use Agenerase after the expiry date which is stated on the bottle and carton.
Slovenian: Zdravila Agenerase ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatlici.
English: If your doctor decides it is inappropriate for you to take ritonavir, you will need to take increased doses of Agenerase (1200
Slovenian: Če je zdravnik odločil, da jemanje ritonavirja za vas ni primerno, boste morali jemati višje odmerke zdravila Agenerase
English: Agenerase capsules contain vitamin E (109 IU/150 mg capsule), therefore additional vitamin E supplementation is not recommended.
Slovenian: Kapsule Agenerase vsebujejo vitamin E (109 i.e./150 mg kapsulo), zato ni priporočljiva dodatna uporaba vitamina E.
English: A causal relationship has been evoked, although the mechanism of action has not been elucidated.
Slovenian: Mehanizem delovanja ni bil pojasnjen, kljub temu pa se domneva o vzročni povezavi.
English: What Agenerase contains
Slovenian: Kaj vsebuje zdravilo Agenerase
English: Plasma HIV-1 RNA below 400 copies/ml
Slovenian: Plazemska vrednost HIV-1 RNA pod 400 kopij/ml (%)
English: Additional mutations observed which may contribute to resistance were: L10V/F/R, I13V, K20R/T, L33F/V, M36I, M46I/L, I47V/L Q58E, I62V, L63P, V77I, I85V, and I93L.
Slovenian: Dodatne mutacije, ki so jih opazili in lahko pripomorejo k odpornosti, so: L10V/F/R, I13V, K20R/T, L33F/V, M36I, M46I/L, I47V/L Q58E, I62V, L63P, V77I, I85V in I93L.
English: Elevated triglycerides, elevated amylase and hyperglycaemia (grade 3-4) were reported primarily in patients with abnormal values at baseline.
Slovenian: O zvišanih vrednostih trigliceridov, zvišanih vrednostih amilaze in o hiperglikemiji (stopnja 3-4) so poročali predvsem pri bolnikih z nenormalnimi osnovnimi vrednostmi.
English: If you have taken more than the prescribed dose of Agenerase, you should contact your doctor or pharmacist immediately for advice.
Slovenian: Če ste vzeli večji odmerek zdravila Agenerase, kot bi smeli Če ste vzeli večji odmerek zdravila Agenerase od predpisanega, se morate nemudoma posvetovati z zdravnikom ali s farmacevtom.
English: These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘buffalo hump').
Slovenian: Spremembe v porazdelitvi maščevja lahko vključujejo izgubo maščevja nog, rok in obraza, nabiranje maščobe v trebuhu (trebušavost) in drugih notranjih organih, povečanje prsi ter maščobne gmote na zadnji strani vratu (‘bivolja grba').
English: Capsule shell: gelatin, glycerol, d-sorbitol (E420) and sorbitans solution, titanium dioxide, red printing ink.
Slovenian: Ovojnica kapsule: želatina, glicerol, raztopina d-sorbitola (E420) in sorbitanov, titanov dioksid, rdeče črnilo za tisk.
English: No dose recommendation can be made in children with hepatic impairment (see section 5.2).
Slovenian: Za otroke z oslabljenim delovanjem jeter ne moremo podati priporočenega odmerka (glejte poglavje 5.2).
English: The frequency categories used are:
Slovenian: Pogostnost je navedena kot: