FrancophonIA/ELRC3.0 huggingface dataset:
English: Dosing by means of the measuring device remains accurate even when crystals are observed.
Croatian: Doziranje pomoću mjerne naprave ostaje precizno, čak i kad se primijete kristali.
English: Previous ADI*
Croatian: Prethodni ADI*
English: Other medicines and Aptivus
Croatian: Drugi lijekovi i Aptivus
English: Number of Patients Age-Median (years) Gender
Croatian: Broj bolesnika Dob-medijan (godine) Spol
English: Tipranavir is extensively bound to plasma proteins (>99.9%).
Croatian: Tipranavir se ekstenzivno veže na proteine plazme (>99,9%).
English: It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Croatian: Smatra se da ovi simptomi nastaju zbog poboljšanja imunološke reakcije tijela, omogućujući tijelu da se bori protiv infekcija koje mogu biti prisutne bez vidljivih simptoma.
English: Administration of activated charcoal may also be used to aid in removal of unabsorbed substance.
Croatian: Primjena aktivnog ugljena je također moguća kao pomoć u uklanjanju neapsorbirane tvari.
English: Date of first opening of the bottle:
Croatian: Datum prvog otvaranja boce:
English: In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
Croatian: U više od polovine prijavljenih slučajeva, liječenje inhibitorima proteaze nastavljeno je ili ponovno uvedeno ukoliko je terapija bila prekinuta.
English: No specific signs and symptoms of overdose are known.
Croatian: Nisu poznati specifični znakovi i simptomi predoziranja.
English: Alpha 1-adrenoreceptor antagonists Alfuzosin
Croatian: Antagonisti alfa 1-adrenoreceptora Alfuzosin
English: Tipranavir: ↔ Valaciclovir: ↔
Croatian: Tipranavir: ↔ Valaciklovir: ↔
English: This adverse reaction was identified through post-marketing surveillance but not observed in randomised controlled clinical trials (n=6300).
Croatian: Ova nuspojava je bila prepoznata putem postmarketinškog nadzora, ali nije bila primijećena u randomiziranim kontroliranim kliničkim ispitivanjima (n=6300).
English: The trial evaluated pharmacokinetics, safety and tolerability, as well as virologic and immunologic responses through 48 weeks.
Croatian: Ispitivanje je ocjenjivalo farmakokinetiku, sigurnost i podnošljivost, kao i virusne i imunološke odgovore tijekom 48 tjedana.
English: Halofantrine, lumefantrine
Croatian: Halofantrin, lumefantrin
English: Mechanism unknown
Croatian: Mehanizam nepoznat
English: Harmful for those suffering from alcoholism.
Croatian: Štetno za alkoholičare.
English: Tipranavir should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Croatian: Tipranavir se primjenjuje tijekom trudnoće samo ako potencijalna korist opravdava potencijalni rizik za fetus.
English: Aptivus contains very small amounts of alcohol (see Aptivus capsules contain ethanol).
Croatian: Aptivus sadrži vrlo male količine alkohola (pogledajte Aptivus kapsule sadrže etanol).
English: It is not known whether Aptivus may be used safely during pregnancy.
Croatian: Nije poznato može li se Aptivus primjenjivati sigurno tijekom trudnoće.
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down the infection.
Croatian: Kada je enzim blokiran, virus se ne razmnožava normalnim putem, čime se usporava infekcija.
English: However, in some cases the role of tipranavir cannot be excluded.
Croatian: Međutim, u nekim slučajevima uloga tipranavira se ne može isključiti.
English: % Male
Croatian: % muški
English: Additional changes included bleeding in rats at high doses (rodents specific).
Croatian: Dodatne promjene su uključivale krvarenja u štakora pri visokim dozama (specifično za glodavce).
English: Data on the 29 patients who switched to capsules during the first 48 weeks are presented.
Croatian: Prikazani su podaci za 29 bolesnika koji su se prebacili na kapsule tijekom prvih 48 tjedana.
English: Patients should be instructed accordingly.
Croatian: Bolesnike je potrebno savjetovati u skladu s time.
English: For this reason it is very important that you tell your doctor about any changes in your health.
Croatian: Iz tog razloga je važno obavijestiti liječnika o svakoj promjeni Vašeg zdravlja.
English: If you are older than 65 years your doctor will exercise caution when prescribing Aptivus soft capsules to you and will closely monitor your therapy.
Croatian: Ako ste stariji od 65 godina, liječnik će Vam s oprezom propisati Aptivus meke kapsule te će pažljivo pratiti Vašu terapiju.
English: A small amount of crystals does not affect the strength or safety of your child's medicine.
Croatian: Malena količina kristala ne utječe na jačinu ili sigurnost lijeka Vašeg djeteta.
English: A total of 10% of patients had previously used enfuvirtide.
Croatian: Ukupno 10% bolesnika je prethodno rabilo enfuvirtid.
English: Total plasma tipranavir concentrations for these samples ranged from 9 to 82 M.
Croatian: Ukupne koncentracije tipranavira u plazmi za ove uzorke varirale su od 9 do 82 M.
English: Once the bottle is opened your child should use the medicine within 60 days.
Croatian: Nakon prvog otvaranja boce, Vaše dijete treba primijeniti lijek u roku 60 dana.
English: Itraconazole or ketoconazole should be used with caution (doses 200 mg/day are not recommended).
Croatian: Itrakonazol ili ketokonazol se primjenjuju s oprezom (doze 200 mg/dan se ne preporučuju).
English: Since currently only limited efficacy and safety data are available for adolescents (see section 5.1) close monitoring of virologic response and tolerance is particularly warranted in this patient group.
Croatian: S obzirom da su podaci o djelotvornosti i sigurnosti u adolescenata ograničeni (vidjeti dio 5.1), posebno se zahtijeva pažljivo praćenje virološkog odgovora i podnošljivosti u ovoj skupini bolesnika.
English: Recommendations for maximal doses of omeprazole or esomeprazole are found in the corresponding product information.
Croatian: Preporuke za maksimalne doze omeprazola ili esomeprazola se nalaze u odgovarajućim informacijama o tim proizvodima.
English: The increase of tipranavir Cmin may be clinically relevant.
Croatian: Povećanje Cmin tipranavira može biti klinički relevantno.
English: Treatment of overdose should consist of general supportive measures, including monitoring of vital signs and observation of the patient's clinical status.
Croatian: Liječenje predoziranja sastoji se od općih suportivnih mjera, uključujući praćenje vitalnih znakova i promatranje kliničkog statusa.
English: Aptivus is supplied in bottles containing 120 capsules.
Croatian: Aptivus je dostupan u bocama sa 120 kapsula.
English: One patient in the tipranavir arm had four mutations.
Croatian: Jedan bolesnik na tipranaviru je imao četiri mutacije.
English: No clinically significant interaction is observed.
Croatian: Nije primijećena klinički značajna interakcija.
English: The clinical implications of these findings are not known.
Croatian: Kliničke implikacije ovih nalaza nisu poznate.
English: If a rash occurs, it is usually mild to moderate.
Croatian: Ako se osip pojavi, obično je blag do umjeren.
English: Aptivus may lead to a loss of effectiveness of some medicines including: - methadone, meperidine (pethidine), used as morphine substitutes
Croatian: Aptivus može dovesti do gubitka učinkovitosti nekih lijekova uključujući: - metadon, meperidin (petidin), primjenjuju se kao zamjena za morfin
English: Do not store below 15°C.
Croatian: Ne čuvati na temperaturi ispod 15°C.
English: Make sure the oral syringe is tightly inserted.
Croatian: Uvjerite se da je oralna štrcaljka čvrsto umetnuta.
English: New ENF No New ENF*
Croatian: Novi ENF Bez novog ENF*
English: No information is available for the parameters AUC and Cmax.
Croatian: Nisu dostupni podaci o AUC i Cmax.
English: Aptivus is not a cure for HIV infection:
Croatian: Aptivus nije lijek za izlječenje infekcije HIV-om:
English: Your doctor will test for these changes.
Croatian: Liječnik će Vas uputiti na testiranja za ove promjene.
English: Monitoring of hepatic tests should be done prior to initiation of therapy, after two, four and then every four weeks until 24 weeks, and then every eight to twelve weeks thereafter.
Croatian: Testove jetrene funkcije potrebno je učiniti prije početka liječenja, nakon dva, četiri i zatim svaka četiri tjedna do 24. tjedna, a nakon toga svakih osam do dvanaest tjedana.
English: Therefore, it is important that you continue taking Aptivus correctly, as described above.
Croatian: Stoga je važno nastaviti s ispravnom primjenom Aptivusa, kako je prethodno opisano.
English: UNIQUE IDENTIFIER --- 2D BARCODE
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
English: The limited data available from a phase IIa study in HIV-infected patients suggest that no significant interaction is expected between nevirapine and TPV/r.
Croatian: Ograničeni podaci dostupni iz ispitivanja faze IIa na bolesnicima zaraženim HIV-om ukazuju da se ne očekuje značajna interakcija između nevirapina i TPV/r.
English: Dosage of methadone may need to be increased.
Croatian: Doze metadona će se možda morati povisiti.
English: Despite an almost half reduction of C12, previous clinical studies with this combination did not evidence an impaired outcome.
Croatian: Usprkos gotovo upola nižim vrijednostima C12, prethodna klinička ispitivanja s ovom kombinacijom nisu ukazala na promjene djelotvornosti.
English: Until you exchange the bottle, please continue to give your child their usual doses of Aptivus oral solution.
Croatian: Dok ne zamijenite bocu, molimo, nastavite davati svom djetetu uobičajene doze Aptivus oralne otopine.
English: Once the bottle is opened the contents must be used within 60 days (stored below 25°C).
Croatian: Nakon otvaranja boce, sadržaj se mora iskoristiti u roku od 60 dana (čuvan na temperaturi ispod 25°C).
English: Further information on possible side effects related to combination antiretroviral treatment: - Bleeding - Increased bleeding.
Croatian: Dodatne informacije o mogućim nuspojavama povezanima s kombiniranim antiretrovirusnim liječenjem: - Krvarenje - pojačano krvarenje.
English: Greater effects may be expected when fluticasone propionate is inhaled.
Croatian: Veći učinak se može očekivati kad se flutikazonpropionat inhalira.
English: Effects of food on oral absorption
Croatian: Učinci hrane na oralnu apsorpciju
English: Tipranavir Cmin ↓ 61% (compared to historical data)
Croatian: Tipranavir Cmin ↓ 61% (u usporedbi s podacima u anamnezi)
English: Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Croatian: Znakovi osteonekroze su ukočenost i bolovi zglobova (osobito kuka, koljena i ramena) i poteškoće u kretanju.
English: In cases where co-administration is necessary, the dose of 10 mg atorvastatin daily should not be exceeded.
Croatian: U slučajevima kada je nužna istodobna primjena, ne smije se prekoračiti dnevna doza od 10 mg atorvastatina.
English: A pharmacokinetic interaction is mechanistically unexpected and the interaction has not been confirmed in a controlled interaction study.
Croatian: Farmakokinetička interakcija je mehanistički neočekivana te nije potvrđena u kontroliranom ispitivanju interakcija.
English: Aptivus capsules should be taken with food.
Croatian: Aptivus kapsule se moraju uzeti s hranom.
English: Before taking Aptivus it should be checked that the oral solution is clear and whether there are crystals or other particles at the bottom of the bottle.
Croatian: Prije uzimanja Aptivusa potrebno je provjeriti da li je oralna otopina bistra, te da li ima kristala ili drugih čestica na dnu boce.
English: Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors, ATC code: J05AE09
Croatian: Farmakoterapijska skupina: antivirusni lijekovi za sistemsku primjenu, inhibitori proteaze, ATK oznaka: J05AE09
English: Interaction Geometric mean change (%)
Croatian: Geometrijska srednja vrijednost promjene (%)
English: It is advisable that the patient writes the date of opening the bottle on the label and/or carton.
Croatian: Savjetuje se da bolesnik zabilježi datum otvaranja boce na naljepnici i/ili kutiji.
English: Phosphodiesterase 5 (PDE5) inhibitors Sildenafil
Croatian: Inhibitori fosfodiesteraze 5 (PDE5) Sildenafil
English: Known and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in the table below.
Croatian: Poznate i teoretske interakcije s odabranim antiretrovirusnim lijekovima i neantiretrovirusnim lijekovima navedene su u tablici u nastavku teksta.
English: Therefore, a modification of Aptivus exposure cannot be ruled out.
Croatian: Stoga se ne može isključiti modifikacija izloženosti Aptivusu.
English: Disulfiram/metronidazole
Croatian: Disulfiram/metronidazol
English: Practical recommendations deriving from this study are displayed below.
Croatian: Praktične preporuke izvedene iz ovog ispitivanja prikazane su u nastavku teksta.
English: You should follow the instructions for these medicines within the supplied Package Leaflets.
Croatian: Potrebno je pratiti upute o tim lijekovima koje se nalaze u priloženim Uputama o lijeku.
English: Do not use this medicine after the expiry date which is stated on the bottle after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci iza oznake „EXP“.
English: UNIQUE IDENTIFIER --- 2D BARCODE 2D barcode carrying the unique identifier included.
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
English: Keep the container in the outer carton.
Croatian: Čuvati spremnik u vanjskoj kutiji.
English: Check with your child's doctor or pharmacist if you are not sure.
Croatian: Provjerite s djetetovim liječnikom ili ljekarnikom ako niste sigurni.
English: Very common (≥ 1/10), common (≥ 1/100 to 1/10), uncommon (≥1/1,000 to 1/100), rare (≥1/10,000 to 1/1,000)
Croatian: Vrlo često (≥ 1/10), često (≥ 1/100 i 1/10), manje često (≥1/1 000 i 1/100), rijetko (≥1/10 000 i 1/1
English: This difference in concentrations does not warrant a dose adjustment.
Croatian: Razlika u koncentracijama ne zahtijeva podešavanje doze.
English: Aptivustreatment is therefore appropriate for your child.
Croatian: Stoga je liječenje Aptivusom odgovarajuće za Vaše dijete.
English: Consistent with the recommendation that HIV-infected mothers should not breast-feed their infants under any circumstances to avoid risking postnatal transmission of HIV, mothers should discontinue breast-feeding if they are receiving Aptivus.
Croatian: U skladu s preporukama da majke zaražene HIV-om ne smiju dojiti svoju dojenčad niti pod jednim uvjetom radi izbjegavanja rizika postnatalnog prijenosa HIV-a, majke moraju prekinuti s dojenjem ako primaju Aptivus.
English: ENF Enfuvirtide; FAS Full Analysis Set; PP Per Protocol; APV/rtv Amprenavir/ritonavir; IDV/rtv Indinavir/ritonavir; LPV/rtv Lopinavir/ritonavir; SQV/rtv Saquinavir/ritonavir
Croatian: ENF enfuvirtid; PP prema protokolu; APV/rtv amprenavir/ritonavir; IDV/rtv indinavir/ritonavir; LPV/rtv lopinavir/ritonavir; SQV/rtv sakvinavir/ritonavir
English: UNIQUE IDENTIFIER --- HUMAN READABLE DATA
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM
English: p-value n (%)
Croatian: p-vrijednost n (%)
English: Women using oestrogens may have an increased risk of non serious rash.
Croatian: Žene koje primjenjuju estrogene mogu imati povećan rizik osipa (ne ozbiljnog).
English: Oral contraceptives and oestrogens
Croatian: Oralni kontraceptivi i estrogeni
English: Dosage reduction and concentration monitoring of desipramine is recommended.
Croatian: Preporučuje se sniženje doza i praćenje koncentracije dezipramina.
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Croatian: Duljina kombinirane antiretrovirusne terapije, primjena kortikosteroida, konzumiranje alkohola, teška imunosupresija, povišeni indeks tjelesne mase, među ostalim, mogu biti neki od mnogih rizičnih faktora za razvoj ove bolesti.
English: Do not give a double dose to make up for a forgotten dose.
Croatian: Nemojte dati dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: At present there are no results from controlled trials evaluating the effect of tipranavir on clinical progression of HIV.
Croatian: Trenutno ne postoje rezultati iz kontroliranih ispitivanja o učinku tipranavira na kliničku progresiju HIV infekcije.
English: In preclinical studies of tipranavir in dogs, an effect on coagulation parameters was not seen.
Croatian: U pretkliničkim ispitivanjima tipranavira na psima, učinak na parametre koagulacije nije bio primijećen.
English: Inhaled beta agonists Salmeterol
Croatian: Inhalacijski beta-agonisti Salmeterol
English: All patients initially received Aptivus oral solution.
Croatian: Svi bolesnici su prvotno dobivali Aptivus oralnu otopinu.
English: The dose for children should not exceed 5 ml (500 mg) twice a day.
Croatian: Dječja doza ne smije prekoračivati 5 ml (500 mg) dvaput dnevno.
English: Each bottle contains 120 soft capsules.
Croatian: Svaka boca sadrži 120 mekih kapsula.
English: It is recommended to start with the lowest dose and careful clinical monitoring is necessary (see section 4.4).
Croatian: Preporučuje se početi s najnižom dozom te je potrebno pažljivo kliničko praćenje (vidjeti dio 4.4).
English: Ask your child's pharmacist how to throw away medicines you no longer use.
Croatian: Pitajte djetetovog ljekarnika kako baciti lijekove koje više ne koristite.
English: Patients using clarithromycin at doses higher than 500 mg twice daily should be carefully monitored for signs of toxicity of clarithromycin and tipranavir.
Croatian: Bolesnici koji primjenjuju klaritromicin u dozama višima od 500 mg dvaput dnevno moraju se pažljivo pratiti radi znakova toksičnosti klaritromicina i tipranavira.
English: Although data available at this stage are currently limited to allow a definitive analysis, they suggest that the pharmacokinetic profile is unchanged in older people and comparable between races.
Croatian: Iako su dostupni podaci trenutno ograničeni, ukazuju da je farmakokinetički profil nepromijenjen u starijih osoba te usporediv među rasama.
English: Fluconazole doses 200 mg/day are not recommended.
Croatian: Doze flukonazola 200 mg/dan se ne preporučuju.
English: Agents that are contraindicated specifically due to the expected magnitude of interaction and potential for serious adverse reactions are detailed in this section, and listed in section 4.3.
Croatian: Lijekovi koji su kontraindicirani specifično zbog očekivane magnitude interakcija i potencijala za teške nuspojave su detaljno prikazani u ovom dijelu, te su navedeni i u dijelu 4.3.
English: In patients less than 12 years of age, however, the oral solution is the only available option for treatment with tipranavir, as no data are available on the efficacy and safety of Aptivus capsules in children less than 12 years of age.
Croatian: Međutim, za bolesnike mlađe od 12 godina oralna otopina je jedina dostupna opcija liječenja tipranavirom s obzirom da ne postoje podaci o učinkovitosti i sigurnosti Aptivus kapsula za mlađe od 12 godina.
English: Turn the bottle upside down and gently withdraw the required amount of Aptivus oral solution.
Croatian: Okrenite bocu naopačke te nježno izvucite potrebnu količinu Aptivus oralne otopine.
English: Serious side effects associated with Aptivus:
Croatian: Ozbiljne nuspojave povezane s Aptivusom:
English: Omeprazole AUC ↓ 70%
Croatian: Omeprazol AUC ↓ 70%
English: You should therefore remain in regular contact with your child's doctor.
Croatian: Stoga mora biti u redovnom kontaktu s djetetovim liječnikom.
English: Primary PI mutations
Croatian: Primarne mutacije IP
English: Interactions between Aptivus and co-administered medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”,once daily as “QD”, twice daily as “BID”).
Croatian: Interakcije između Aptivusa i istodobno primjenjivanih lijekova navedene su u tablici (povećanje je naznačeno kao “↑”, smanjenje kao “↓”, odsustvo promjene kao “↔”, jedanput dnevno kao “QD”, dvaput dnevno kao “BID”).
English: Carcinogenicity studies of tipranavir in mice and rats revealed tumourigenic potential specific for these species, which are regarded as of no clinical relevance.
Croatian: Ispitivanja kancerogenosti tipranavira na miševima i štakorima otkrila su tumorogeni potencijal specifičan za ove vrste, koji se ne smatra klinički značajnim.
English: The paediatric dose should not exceed the 500 mg/200 mg dose.
Croatian: Pedijatrijska doza ne smije prekoračiti 500 mg/200 mg.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Aptivus.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Aptivus.
English: Always give your child this medicine exactly as the doctor has advised.
Croatian: Uvijek svom djetetu dajte ovaj lijek točno onako kako Vam je rekao liječnik.
English: Rarely these muscle disorders have been serious, involving breakdown of muscle tissue (rhabdomyolysis).
Croatian: Rijetko su ovakvi poremećaji mišića teški, uključujući poremećaj mišićnog tkiva (rabdomioliza).
English: Recombinant viruses showing ≥ 3fold resistance to tipranavir grow at less than 1% of the rate detected for wild type HIV-1 in the same conditions.
Croatian: Rekombinantni virusi koji pokazuju ≥ 3-struku rezistenciju na tipranavir rastu stopom koja iznosi manje od 1% stope rasta divljeg tipa HIV-1 u istim uvjetima.
English: However, if atorvastatin is specifically required for patient management, it should be started with the lowest dose and careful monitoring is necessary.
Croatian: Međutim, ako se za zbrinjavanje bolesnika posebno zahtijeva atorvastatin, potrebno je početi s najnižom dozom te bolesnika pažljivo pratiti.
English: Protein binding studies have shown that the antiviral activity of tipranavir decreases on average 3.75fold in conditions where human serum is present.
Croatian: Ispitivanja vezanja na proteine pokazala su da se antivirusna aktivnost tipranavira smanjuje u prosjeku 3,75 puta u prisustvu ljudskog seruma.
English: You should return the bottle to your child's pharmacist or doctor for a replacement as soon as possible if: - there is more than a thin layer of crystals at the bottom of the bottle, or - you are uncertain about the amount of crystals you see or - any other particles are visible.
Croatian: Potrebno je vratiti bocu djetetovom ljekarniku ili liječniku i zamijeniti ju, što je prije moguće, ako: - je na dnu boce uočljivo više od tankog sloja kristala, ili - niste sigurni o količini kristala koju vidite ili - su vidljive neke druge čestice.
English: The clinical significance of these observations has not been fully explored.
Croatian: Klinički značaj ovih opservacija nije u potpunosti istražen.
English: Due to Aptivus containing small amounts of sorbitol, patients with rare hereditary problems of fructose intolerance should not take this medicine.
Croatian: Aptivus sadrži male količine sorbitola, pa bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze ne bi trebali uzimati ovaj lijek.
English: If affected, your child should not drive or operate machinery.
Croatian: Ako utječu, Vaše dijete ne smije upravljati vozilima ili strojevima.
English: If you notice more than a thin layer of crystals at the bottom of the bottle you should: - give the next dose - return the bottle to the pharmacist or doctor as soon as possible for a fresh supply.
Croatian: Ako primijetite sloj kristala deblji od lista papira na dnu boce, potrebno je: - dati sljedeću dozu - vratiti bocu ljekarniku ili liječniku što je prije moguće radi novog izdavanja.
English: Value
Croatian: Vrijednost