FrancophonIA/ELRC3.0 huggingface dataset:
English: • Continue to take this medicine until your doctor tells you otherwise.
Croatian: • Uzimajte ovaj lijek dok Vam liječnik ne kaže suprotno.
English: • If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine because it contains propylene glycol and alcohol.
Croatian: • Ako ste trudni ili dojite, razgovarajte sa svojim liječnikom ili ljekarnikom prije nego što uzmete ovaj lijek jer on sadrži propilenglikol i alkohol.
English: Cohort II
Croatian: Kohorta II
English: Due to the possibility of undetected fructose intolerance, this medicinal product should only be given to babies and infants after consultation with a doctor.
Croatian: Zbog mogućnosti postojanja neotkrivenog nepodnošenja fruktoze, ovaj se lijek smije davati djeci i dojenčadi samo nakon konzultacije s liječnikom.
English: 15 to 25
Croatian: 15 do 25
English: There are limited pharmacokinetic data in children below 2 years of age.
Croatian: Ograničeni su farmakokinetički podaci u djece mlađe od 2 godine.
English: Date of first authorisation: 20 March 2001 Date of latest renewal: 20 March 2011
Croatian: Datum prvog odobrenja: 20. ožujka 2001.
English: For erectile dysfunction:
Croatian: Za erektilnu disfunkciju:
English: After removing the air bubbles, look at the dose mark.
Croatian: 5. Nakon uklanjanja mjehurića zraka, pogledajte oznaku za dozu.
English: Based on the data mentioned, the malformative risk is unlikely in humans.
Croatian: Na osnovu spomenutih podataka, rizik malformacija kod čovjeka nije vjerojatan.
English: • You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Croatian: • HIV virus možete prenijeti čak i dok uzimate ovaj lijek, iako je tada rizik od prijenosa manji zbog učinkovite antiretrovirusne terapije.
English: How should I store Kaletra and for how long?
Croatian: Kako trebam čuvati lijek Kaletra i koliko dugo?
English: • increased appetite;
Croatian: • povećan apetit;
English: Effects on the electrocardiogram
Croatian: Utjecaji na elektrokardiogram
English: If an erection lasts longer than 4 hours, you should get medical help immediately to avoid permanent damage to your penis.
Croatian: Ukoliko erekcija traje dulje od 4 sata, odmah potražite pomoć liječnika kako bi izbjegli trajno oštećenje penisa.
English: Autoimmune disorders may occur many months after the start of treatment.
Croatian: Autoimuni poremećaji se mogu pojaviti više mjeseci nakon početka liječenja.
English: No clinical relevant interaction expected.
Croatian: Ne očekuje se klinički značajna interakcija.
English: Two pack sizes are available:
Croatian: Dostupne su dvije veličine pakiranja:
English: Administration of activated charcoal may also be used to aid in removal of unabsorbed active substance.
Croatian: Može se dati i aktivni ugljen, kao pomoć pri uklanjanju neapsorbirane djelatne tvari.
English: Your doctor will advise on the number of tablets to be taken.
Croatian: Liječnik će Vam savjetovati broj tableta koje trebate uzimati.
English: Rinse the syringe and plunger with clean water.
Croatian: Isperite štrcaljku i klip čistom vodom.
English: to < 1/10), uncommon (≥ 1/1000 to < 1/100) and not known (cannot be estimated from the available data).
Croatian: i < 1/100) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Contents of the pack and other information What Kaletra contains
Croatian: Sadržaj pakiranja i druge informacije Što Kaletra sadrži
English: For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
Croatian: Za lipide, u nekim slučajevima postoji dokaz o učinku liječenja, dok za debljanje nema čvrstog dokaza o povezanosti s bilo kojim posebnim liječenjem.
English: Conclusions regarding the relevance of particular mutations or mutational patterns are subject to change with additional data, and it is recommended to always consult current interpretation systems for analysing resistance test results.
Croatian: Zaključci o važnosti pojedinih mutacija ili mutacijskih uzoraka mijenjaju se s pojavom dodatnih podataka i preporučuje se uvijek u analizi rezultata testa rezistencije konzultirati sustav interpretacije koji je u tom trenutku u uporabi.
English: Contraceptives);
Croatian: Kontraceptivi);
English: Antipsychotics/ Neuroleptics
Croatian: Antipsihotici/ neuroleptici
English: • decreased sexual desire;
Croatian: • smanjena seksualna želja;
English: This may be unsuitable in hereditary fructose intolerance.
Croatian: To može biti neprikladno u slučajevima nasljedne netolerancije fruktoze.
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: Pretpostavlja se da se ti simptomi javljaju zbog poboljšanja u odgovoru imunološkog sustava omogućavajući organizmu da se bori protiv infekcije koja je bila prisutna bez jasnih simptoma.
English: Virologic Response of Study Subjects at Week 48 Study 802 QD BID Difference [95% CI]
Croatian: Virološki odgovor ispitanika u 48. tjednu studije 802 QD BID Razlika [95% CI]
English: • Store in a refrigerator (2°C - 8°C).
Croatian: • Čuvati u hladnjaku (2°C - 8°C).
English: Your doctor will discuss with you and determine which medicines are best for you.
Croatian: Liječnik će odrediti koji od tih lijekova su najbolji za Vas.
English: Decreased exposure of Kaletra may result in potential loss of virological response.
Croatian: Smanjena izloženost lijeku Kaletra može rezultirati potencijalnim gubitkom virološkog odgovora.
English: Do not throw away any medicines via wastewater.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: Kaletra tablets have also shown less pharmacokinetic variability under all meal conditions compared to Kaletra soft capsules.
Croatian: Kaletra tablete su također pokazale manju farmakokinetičku varijabilnost u svim uvjetima obroka u odnosu na Kaletra meke kapsule.
English: Sedatives/hypnotics
Croatian: Sedativi/hipnotici
English: Observed data
Croatian: Uočeni podaci
English: A causal relationship had been evoked, although the mechanism of action had not been elucidated.
Croatian: Posumnjalo se na uzročno-posljedičnu vezu, premda mehanizam djelovanja nije rasvijetljen.
English: Talk to your doctor or pharmacist before taking Kaletra.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Kaletra.
English: Body Surface Area (m2)
Croatian: Površina tijela (m2)
English: For larger volumes an alternative pack is available.
Croatian: Za veće volumene dostupno je alternativno pakiranje.
English: Thereby, increasing the risk of extreme sedation and respiratory depression from these agents.
Croatian: Time je povišen rizik od ekstremne sedacije i respiratorne depresije uzrokovane ovim tvarima.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator
Croatian: POSEBNE MJERE ČUVANJA Čuvati u hladnjaku
English: What Kaletra looks like and contents of the pack
Croatian: Kako Kaletra izgleda i sadržaj pakiranja
English: • Kaletra does not reduce the risk of passing HIV to others.
Croatian: • Kaletra ne smanjuje rizik prenošenja HIV-a na druge osobe.
English: For smaller volumes an alternative pack is available.
Croatian: Za manje volumene dostupno je alternativno pakiranje.
English: • abnormal closure of one of the valves (tricuspid valve in your heart);
Croatian: • nepravilno zatvaranje jednog od zalistaka (trikuspidalni zalistak u srcu);
English: (equivalent to 245 mg tenofovir disoproxil)
Croatian: (što odgovara 245 mg tenofovirdizoproksila)
English: Mutations V82A, I54V and M46I emerged most frequently.
Croatian: Najčešće su se pojavljivale mutacije V82A, I54V i M46I.
English: Appropriate precautions (e.g. use of a condom) should be taken to prevent passing on the disease through sexual contact.
Croatian: Moraju se poduzeti odgovarajuće mjere opreza (npr. kondomi) kako bi se spriječilo prenošenje bolesti spolnim putem.
English: 15 to 20 kg > 20 to 25 kg > 25 to 30 kg > 30 to 35 kg > 35 to 40 kg
Croatian: 15 do 20 kg > 20 do 25 kg > 25 do 30 kg > 30 do 35 kg > 35 do 40 kg
English: There were no reported events of failure attributed to therapy limiting toxicity.
Croatian: Nije prijavljen nijedan slučaj neuspjeha zbog toksičnosti koja ograničava liječenje.
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 polovice zabilježenih slučajeva liječenje inhibitorima proteaze je nastavljeno ili je ponovno započeto ako je došlo do prekida.
English: Take care when dosing children.
Croatian: Treba obratiti pažnju kod doziranja u djece.
English: Do not use the dosing syringes supplied with Kaletra oral solution to administer any other medicines you or your child may be taking.
Croatian: Nemojte koristiti štrcaljke za doziranje koje ste dobili s Kaletra oralnom otopinom za primjenu drugih lijekova koje Vi ili Vaše dijete možda uzimate.
English: • uncontrolled shaking of the body;
Croatian: • nekontrolirano drhtanje tijela;
English: Studies in rats revealed that lopinavir is excreted in the milk.
Croatian: Ispitivanja u štakora pokazala su da se lopinavir izlučuje u mlijeko.
English: • astemizole or terfenadine (commonly used to treat allergy symptoms - these medicines may be available without prescription);
Croatian: • astemizol ili terfenadin (lijekovi koji se obično koriste za liječenje simptoma alergija - ovi lijekovi mogu se dobiti bez recepta);
English: PDE5 inhibitors
Croatian: PDE5 inhibitori
English: Dosage adjustment for midazolam should be considered especially if more than a single dose of midazolam is administered.
Croatian: Mora se razmotriti prilagođavanje doze midazolama, osobito ako se daje više od jedne doze midazolama.
English: Paediatric population aged from 14 days and older The oral solution formulation is the recommended option for the most accurate dosing in children based on body surface area or body weight.
Croatian: Pedijatrijska populacija u dobi od 14 dana i starija Oralna otopina preporučena je formulacija za najpreciznije doziranje u djece zasnovano na površini tijela ili tjelesnoj težini.
English: If you are currently taking any of these medicines, ask your doctor about making necessary changes either in the treatment for your other condition(s) or in your antiretroviral treatment.
Croatian: Ako uzimate bilo koji od spomenutih lijekova, zamolite svog liječnika da napravi nužne izmjene u liječenju drugih bolesti ili u antiretrovirusnom liječenju.
English: Let the syringe dry completely before you use that syringe for dosing.
Croatian: Ostavite štrcaljku da se posve osuši prije nego je upotrijebite za doziranje.
English: For volumes up to 2 ml.
Croatian: Za volumene do 2 ml.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja u životinja pokazala su da postoji reproduktivna toksičnost (vidjeti dio 5.3).
English: Further stratification within each group was 1:1 (tablet versus soft capsule).
Croatian: Daljnja podjela svake grupe bila je također u omjeru 1:1 (tablete naspram mekih kapsula).
English: The 16 viruses that displayed > 20-fold change in susceptibility all contained mutations at positions 10, 54, 63 plus 82 and/or 84.
Croatian: Svih 16 virusa koji su pokazali promjenu osjetljivosti za > 20 puta sadržavalo je mutacije na položajima 10, 54, 63 plus 82 i/ili 84.
English: If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Croatian: Ukoliko primijetite bilo koji simptom infekcije ili druge simptome kao što su mišićna slabost, slabost koja započinje u rukama i stopalima te se širi gore prema trupu, lupanje srca, nevoljno drhtanje ili hiperaktivnost, molimo da odmah obavijestite svog liječnika kako bi dobili potrebno liječenje.
English: As a general rule, it is recommended that mothers infected by HIV do not breastfeed their babies under any circumstances in order to avoid transmission of HIV.
Croatian: Kao opće pravilo, ženama zaraženim HIV-om se ne preporučuje dojenje njihove djece ni u kojim okolnostima kako bi se izbjegao prijenos HIV-a.
English: In some cases the hepatic dysfunction was serious.
Croatian: U nekim slučajevima disfunkcija jetre je bila ozbiljna.
English: Integrase inhibitor Raltegravir
Croatian: Inhibitori integraze Raltegravir
English: Do not take a double dose to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili propuštenu.
English: Based on the current data available, Kaletra should not be administered once daily in paediatric patients (see section 5.1).
Croatian: Na temelju trenutno dostupnih podataka, Kaletra se ne smije dozirati jednom dnevno kod pedijatrijskih bolesnika (vidjeti dio 5.1).
English: It is not known whether this medicinal product is excreted in human milk.
Croatian: Nije poznato izlučuje li se ovaj lijek u majčino mlijeko u ljudi.
English: Kaletra contains glycerol which is harmful in high doses.
Croatian: Kaletra sadrži glicerol koji je štetan u visokim dozama.
English: Special attention should be given to accurate calculation of the dose of Kaletra, transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors and overdose.
Croatian: Posebna pozornost se mora pridati točnom izračunu doze lijeka Kaletra, propisivanju redoslijeda liječenja, davanju informacija i uputama za doziranje kako bi se smanjio rizik od pogrešaka pri liječenju i predoziranja.
English: • medicines that cause a reaction with alcohol (e.g. disulfiram).
Croatian: • lijekove koji uzrokuju reakciju s alkoholom (npr. disulfiram).
English: Overall failure rate combining the treatment differences across age strata, weighted by the precision of the estimate within each age stratum p=0.015 (Cohort I); p< 0.001 (Cohort II)
Croatian: Ukupna stopa neuspjeha koja objedinjuje razlike između liječenja u različitim dobnim kategorijama, ponderirana prema preciznosti procjene unutar svake dobne kategorije p = 0,015 (kohorta I); p < 0,001 (kohorta II)
English: HIV CCR5 - antagonist Maraviroc
Croatian: HIV CCR5 antagonisti Maravirok
English: • dizziness, anxiety, difficulty in sleeping;
Croatian: • omaglica, tjeskoba, poteškoće sa spavanjem;
English: After each dose of Kaletra separate the plunger and the syringe.
Croatian: Nakon svake doze lijeka Kaletra razdvojite klip i štrcaljku.
English: The appropriate doses for this combination, with respect to efficacy and safety, have not been established.
Croatian: Odgovarajuće doze, s obzirom na djelotvornost i sigurnost, za tu kombinaciju nisu utvrđene.
English: (see section 4.5); - riociguat is not recommended (see section 4.5); - vorapaxar is not recommended (see section 4.5); - fusidic acid in osteo-articular infections is not recommended (see section 4.5); - salmeterol is not recommended (see section 4.5); - rivaroxaban is not recommended (see section 4.5).
Croatian: - riocigvatom se ne preporučuje (vidjeti dio 4.5); - vorapaksarom se ne preporučuje (vidjeti dio 4.5); - fusidatnom kiselinom kod osteoartikularne infekcije se ne preporučuje (vidjeti dio 4.5); - salmeterolom se ne preporučuje (vidjeti dio 4.5); - rivaroksabanom se ne preporučuje (vidjeti dio 4.5).
English: Antiviral activity in vitro
Croatian: Antivirusna aktivnost in vitro
English: While exposure eliciting these changes were comparable to or below human clinical exposure, dosages in animals were over 6-fold the recommended clinical dose.
Croatian: Dok je izloženost koja je izazvala te promjene bila usporediva s kliničkom izloženošću u ljudi ili je bila manja, doze su u životinja bile više od šest puta veće od preporučenih kliničkih doza.
English: When you travel or need to stay in the hospital make sure you will have enough Kaletra to last until you can get a new supply.
Croatian: Ukoliko putujete ili ostajete neko vrijeme u bolnici, uzmite dovoljnu količinu lijeka Kaletra koja će potrajati dok ne dobijete novu količinu lijeka Kaletra.
English: Cortisol levels ↓ 86%
Croatian: Razine kortizola ↓ 86%
English: • low number of red blood cells, low number of white blood cells which are usually used to fight infection;
Croatian: • nizak broj crvenih krvnih stanica, nizak broj bijelih krvnih stanica koje sudjeluju u obrani organizma od infekcije;
English: The syringe has two main parts, a ‘plunger' and a ‘barrel'.
Croatian: Štrcaljka ima dva glavna dijela, „klip“ i „tijelo“.
English: Fluticasone propionate, 50 µg intranasal 4 times daily:
Croatian: Flutikazonpropionat, 50 µg intranazalno četiri puta na dan:
English: Patients were administered either the tablet or the soft capsule formulation for 8 weeks, after which all patients were administered the tablet formulation once daily or twice daily for the remainder of the study.
Croatian: Bolesnicima je davana ili formulacija tableta ili formulacija mekih kapsula kroz 8 tjedana, nakon čega je svim bolesnicima davana samo formulacija tableta jednom dnevno ili dva puta dnevno u preostalom dijelu studije.
English: The safety and efficacy of Kaletra in children aged less than 2 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Kaletra u djece mlađe od dvije godine nisu još ustanovljene.
English: The dose increase did not result in a significant increase in the plasma lopinavir concentration.
Croatian: Povećanje doze nije dovelo do značajnog povećanja plazmatskih koncentracija lopinavira.
English: Treatment of overdose with Kaletra is to consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Croatian: Liječenje predoziranja lijekom Kaletra treba se sastojati od općih suportivnih mjera, uključivši praćenje vitalnih znakova i kliničkog statusa bolesnika.
English: (relative to indinavir 800 mg TID alone)
Croatian: (u odnosu na indinavir 800 mg TID sam)
English: Antibiotics Clarithromycin
Croatian: Antibiotici Klaritromicin
English: • Do not stop or change the daily dose of Kaletra without first consulting with your doctor.
Croatian: • Ne prekidajte uzimanje i ne mijenjajte dnevnu dozu lijeka Kaletra bez prethodne konzultacije s liječnikom.
English: For the treatment of pulmonary arterial hypertension:
Croatian: Za liječenje plućne arterijske hipertenzije:
English: • It is important to keep Kaletra in the bottle it came in and replace the bottle cap after each dose.
Croatian: • Važno je čuvati lijek Kaletra u originalnoj boci i vratiti zatvarač na bocu nakon svake doze.
English: Pharmaco-therapeutic group: antivirals for systemic use, antivirals for treatment of HIV infections, combinations, ATC code: J05AR10
Croatian: Farmakoterapijska skupina: antivirusni lijekovi za sistemsku primjenu, kombinirani antivirusni lijekovi za liječenje infekcije HIV-om, ATK oznaka: J05AR10
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu
English: If you are not sure how to use the oral dosing syringe ask your doctor, pharmacist or nurse.
Croatian: Ako niste sigurni kako koristiti štrcaljku za primjenu kroz usta, pitajte svog liječnika, ljekarnika ili medicinsku sestru.
English: Your doctor will advise on the amount of Kaletra to be taken.
Croatian: Liječnik će Vam savjetovati količinu lijeka Kaletra koju trebate uzimati.
English: Wash the plunger and the syringe with washing up liquid and warm water as soon as you can; you may soak both in soapy water for up to 15 minutes.
Croatian: Čim budete u mogućnosti operite klip i štrcaljku tekućim deterdžentom i toplom vodom; možete oboje namočiti u vodi sa sredstvom za pranje suđa tijekom 15 minuta.
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Croatian: Bolesnike se mora savjetovati da potraže liječnički savjet ukoliko osjete bol u zglobovima, ukočenost zglobova ili teškoće u kretanju.
English: Particular risk of toxicity in relation to the amount of alcohol and propylene glycol contained in Kaletra oral solution
Croatian: Poseban rizik od toksičnosti s obzirom na količinu alkohola i propilenglikola u Kaletra oralnoj otopini
English: Thirty-nine patients (39%) discontinued the study, including 16 (16%) discontinuations due to adverse events, one of which was associated with a death.
Croatian: 39 bolesnika (39%) je prekinulo ispitivanje uključujući 16 (16%) prekida zbog nuspojava, od kojih je jedna povezana sa smrću.
English: The clinical significance of reduced abacavir and zidovudine concentrations is unknown.
Croatian: Klinički značaj smanjenih koncentracija abakavira i zidovudina nije poznat.
English: • impotence, abnormally heavy or extended menstrual flow or a lack of menstruation;
Croatian: • impotencija, preobilno ili produženo menstrualno krvarenje ili izostanak menstruacije;
English: Known and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in the table below.
Croatian: Poznate i teoretski moguće interakcije s odabranim antiretroviroticima i lijekovima koji nisu antiretrovirotici navedene su u tablici niže.
English: Greater effects may be expected when fluticasone propionate is inhaled.
Croatian: Jači se učinci mogu očekivati kada se flutikazonpropionat inhalira.
English: Lopinavir/ritonavir has been evaluated in over 3000 women during pregnancy, including over 1000 during the first trimester.
Croatian: Lopinavir/ritonavir je ispitivan u više od 3000 žena tijekom trudnoće, uključujući više od njih 1000 tijekom prvog tromjesečja.
English: • Your doctor will decide the right dose based on the child's height and weight.
Croatian: • Liječnik će odlučiti o odgovarajućoj dozi na temelju djetetove težine i visine.
English: It is therefore important that you remain under the supervision of your doctor while taking Kaletra.
Croatian: Stoga je važno da budete pod nadzorom liječnika za vrijeme liječenja lijekom Kaletra.
English: The prevalence of birth defects after any trimester exposure to lopinavir is comparable to the prevalence observed in the general population.
Croatian: Prevalencija kongenitalnih oštećenja nakon izloženosti lopinaviru u bilo kojem tromjesečju je usporediva s prevalencijom zabilježenom kod opće populacije.
English: It is recommended that INR (international normalised ratio) be monitored.
Croatian: Preporučuje se praćenje međunarodnog normaliziranog omjera (INR).
English: Lopinavir: ↔ (relative to historical comparison)
Croatian: Lopinavir: ↔ (u odnosu na prethodne usporedbe)
English: Kaletra is administered orally and should always be taken with food (see section 5.2).
Croatian: Kaletra se primjenjuje peroralno i mora se uvijek uzeti s hranom (vidjeti dio 5.2).
English: As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account in order to characterise the safety for the foetus.
Croatian: Kao opće pravilo, pri donošenju odluke o uporabi antiretrovirusnih lijekova za liječenje HIV infekcije kod trudnih žena i posljedično smanjenje rizika vertikalnog prijenosa HIV-a na novorođenče, moraju se uzeti u obzir podaci dobiveni kod životinja kao i klinička iskustva kod trudnica kako bi se utvrdila sigurnost za fetus.
English: Moreover, in case of withdrawal of glucocorticoids progressive dose reduction may have to be performed over a longer period.
Croatian: Štoviše, u slučaju obustave glukokortikoida možda će dozu trebati progresivno smanjivati tijekom dužeg vremenskog razdoblja.