FrancophonIA/ELRC3.0 huggingface dataset:
English: If you stop taking Isentress It is important that you take Isentress exactly as your doctor has instructed.
Croatian: Ako prestanete uzimati Isentress Važno je da Isentress uzimate točno onako kako Vas je uputio liječnik.
English: Children and adolescents 2 to 18 years of age
Croatian: Djeca i adolescenti u dobi od 2 do 18 godina
English: • You can ask your doctor or pharmacist for a list of medicines that interact with Isentress.
Croatian: • Od svog liječnika ili ljekarnika možete zatražiti popis lijekova za koje postoji mogućnost interakcije s lijekom Isentress.
English: See section 4.4 regarding the need to administer raltegravir with two other active agents.
Croatian: Vidjeti dio 4.4 za informacije o potrebi da se raltegravir primjenjuje s dva druga aktivna lijeka.
English: If you notice any of these symptoms please inform your doctor.
Croatian: Ako primijetite neki od tih simptoma, obavijestite svog liječnika.
English: Frequencies are defined as common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), and not known (cannot be estimated from the available data).
Croatian: Učestalost pojavljivanja definirana je kao: često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Choose the correct syringe for your child's dose:
Croatian: Odaberite pravu štrcaljku za djetetovu dozu:
English: Date of first authorisation: 20 December 2007 Date of latest renewal: 14 May 2014
Croatian: Datum prvog odobrenja: 20. prosinca 2007.
English: Once absorbed, both formulations of raltegravir exhibit similar systemic pharmacokinetics.
Croatian: Nakon što se apsorbiraju, obje formulacije raltegravira pokazuju sličnu sistemsku farmakokinetiku.
English: The safety and efficacy of raltegravir in preterm (<37 weeks of gestation) and low birth weight (<2000 g) newborns have not been established.
Croatian: Sigurnost i djelotvornost raltegravira u nedonoščadi (< 37 tjedana gestacije) i novorođenčadi male porođajne težine (< 2000 g) nisu ustanovljene.
English: Dose proportionality has not been established in patients.
Croatian: Proporcionalnost doza nije ustanovljena u bolesnika.
English: (Have one of each size ready, but you only need 1 or 2, depending on the size of the dose)
Croatian: 3 štrcaljke (pripremite po jednu štrcaljku svake veličine, iako će Vam trebati samo 1 ili 2, ovisno o veličini doze)
English: • However, if it is time for your next dose, skip the missed dose and go back to your regular schedule.
Croatian: • Međutim, ako je već vrijeme za sljedeću dozu, preskočite propuštenu dozu i nastavite uzimati lijek prema uobičajenom rasporedu.
English: Volume (Dose) of Suspension to be Administered
Croatian: Volumen (doza) suspenzije koji treba primijeniti
English: Number with genotype available One patient had a mutation at the 155 position.
Croatian: Jedan je bolesnik imao mutaciju na položaju 155.
English: Dose for children of 2 through 11 years of age
Croatian: Doza za djecu u dobi od 2 do 11 godina
English: Table 1 displays all available interaction study data along with recommendations for co-administration.
Croatian: Tablica 1 sadrži sve dostupne podatke iz ispitivanja interakcija s preporukama za istodobnu primjenu.
English: The doctor will tell you how many chewable tablets the child must take.
Croatian: Liječnik će Vam reći koliko tableta za žvakanje dijete mora uzimati.
English: • buzzing, hissing, whistling, ringing or other persistent noise in the ears
Croatian: • zujanje, šištanje, pištanje, zvonjenje ili neki drugi neprekidni zvukovi u ušima
English: Your doctor may consider increasing your dose of Isentress if you are taking rifampicin.
Croatian: Liječnik će možda razmisliti o povećanju doze lijeka Isentress ako uzimate rifampicin.
English: • Before you give Isentress to your child, check the expiration date.
Croatian: • Prije nego što date Isentress svome djetetu, provjerite rok valjanosti.
English: DO NOT SHAKE the mixture
Croatian: NEMOJTE TRESTI mješavinu.
English: *Number of patients with intensive pharmacokinetic (PK) results at the final recommended dose.
Croatian: *Broj bolesnika s intenzivnim farmakokinetičkim (PK) rezultatima pri konačnoj preporučenoj dozi.
English: Additional side effects in children and adolescents • hyperactivity
Croatian: Dodatne nuspojave u djece i adolescenata • hiperaktivnost.
English: • The amount of Isentress depends on your child'sage and weight, so it will change over time.
Croatian: • Količina lijeka Isentress ovisi o djetetovoj dobi i tjelesnoj težini, pa će se s vremenom mijenjati.
English: In vitro, raltegravir is a weak inhibitor of organic anion transporter (OAT) 1 (IC50 of 109 µM) and OAT3 (IC50 of 18.8 µM).
Croatian: In vitro, raltegravir je slabi inhibitor transportera organskih aniona (OAT) 1 (IC50 od 109 µM) i OAT3 (IC50 od 18,8 µM).
English: All interaction studies were performed in adults.
Croatian: Ispitivanja interakcija provedena su samo u odraslih.
English: Re-check the amount of water in the syringe.
Croatian: Ponovno provjerite količinu vode u štrcaljki.
English: Then find the mL mark on the syringe barrel that matches your child's dose.
Croatian: Zatim pronađite oznaku za ml na tijelu štrcaljke koja odgovara dozi Vašeg djeteta.
English: If you do take more than you should, contact your doctor.
Croatian: Ako uzmete više nego što ste trebali, javite se liječniku.
English: The tablets should not be chewed, crushed or split due to anticipated changes in the pharmacokinetic profile.
Croatian: Tablete se ne smiju žvakati, drobiti niti lomiti zbog očekivanih promjena u farmakokinetičkom profilu.
English: Granules for oral suspension.
Croatian: Granule za oralnu suspenziju.
English: Patients should be advised that current anti-retroviral therapy does not cure HIV and has not been proven to prevent the transmission of HIV to others through blood contact.
Croatian: Bolesnike treba upozoriti da sadašnja antiretrovirusna terapija neće izliječiti HIV infekciju i nije dokazano da ona sprječava prijenos virusa HIV-a na druge krvlju.
English: • Do not start taking a new medicine without telling your doctor.
Croatian: • Nemojte početi uzimati neki novi lijek ako prethodno niste o tome obavijestili svog liječnika.
English: Use the dose amount in ‘mL' prescribed by the doctor.
Croatian: Odmjerite dozu u ml koju je propisao liječnik.
English: If you are not sure, call your doctor.
Croatian: Ako Vam nešto nije jasno, nazovite svog liječnika.
English: Move this part of the plunger to the correct mark on the syringe
Croatian: Pomaknite ovaj dio klipa do odgovarajuće oznake na štrcaljki
English: Use a clock or timer to time for 45 seconds.
Croatian: Mjerite 45 sekundi satom ili štopericom.
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Croatian: Bilo koje simptome upale treba procijeniti i po potrebi započeti liječenje.
English: (mechanism of interaction unknown)
Croatian: (mehanizam interakcije je nepoznat)
English: Effects at exposure levels sufficiently in excess of clinical exposure levels indicate no special hazard for humans.
Croatian: Učinci lijeka pri razinama izloženosti dovoljno višima od razina u kliničkoj izloženosti ne ukazuju na poseban rizik za ljude.
English: If you do take too many tablets, contact your doctor.
Croatian: Ako uzmete previše tableta, javite se liječniku.
English: Parents and/or caregivers should be instructed to read the instructions for use booklet before preparing and administering ISENTRESS granules for oral suspension to paediatric patients.
Croatian: Roditelje i/ili skrbnike treba uputiti da pročitaju knjižicu s uputama za primjenu prije pripreme i primjene ISENTRESS granula za oralnu suspenziju pedijatrijskim bolesnicima.
English: Geometric coefficient of variation.
Croatian: Geometrijski koeficijent varijacije.
English: Complete details on preparation and administration of the suspension can be found in the instructions for use booklet that is included in the carton.
Croatian: Potpune informacije o pripremi i primjeni suspenzije mogu se naći u knjižici s uputama za primjenu koja se nalazi u kutiji.
English: Read all of this leaflet carefully before you start giving this medicine to your child because it contains important information.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete davati ovaj lijek svom djetetu jer sadrži važne podatke.
English: †Geometric coefficient of variation.
Croatian: †Geometrijski koeficijent varijacije.
English: The types and rates of specific cancers were those expected in a highly immunodeficient population.
Croatian: Vrste i stope pojedinih specifičnih vrsta raka bile su u okviru očekivanih za populaciju s izraženom imunodeficijencijom.
English: If you are the parent or carer of a child taking Isentress, please read this information carefully.
Croatian: Ako ste roditelj ili skrbnik djeteta koje uzima Isentress, pažljivo pročitajte ove informacije.
English: Note: If the mother has taken ISENTRESS 2-24 hours before delivery, the infant's first dose should be given between 24-48 hours after birth.
Croatian: Ako je majka uzela ISENTRESS 2 - 24 sata prije poroda, novorođenčetu prvu dozu treba dati 24 - 48 sati nakon poroda.
English: Recommended Dose for ISENTRESS For Oral Suspension in Full-Term Neonates (Birth to 4 weeks [28 days] of age*
Croatian: Preporučena doza lijeka ISENTRESS za oralnu suspenziju za terminsku novorođenčad (od rođenja do dobi od 4 tjedna [28 dana])*
English: The most frequently reported adverse reactions during treatment were headache, nausea and abdominal pain.
Croatian: Najčešće prijavljivane nuspojave tijekom liječenja bile su glavobolja, mučnina i bol u abdomenu.
English: • NEW Amount of water for mixing the product
Croatian: • NOVA količina vode za miješanje lijeka
English: With twice-daily dosing, pharmacokinetic steady state is achieved rapidly, within approximately the first 2 days of dosing.
Croatian: Primjenom lijeka dvaput na dan farmakokinetičko stanje dinamičke ravnoteže postiže se brzo, otprilike unutar prva 2 dana primjene.
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: Vjeruje se da su ti simptomi posljedica poboljšanog imunološkog odgovora, koji omogućuje da se tijelo bori protiv infekcija koje su možda bile prisutne bez vidljivih simptoma.
English: 1.5 mL (15 mg) twice daily *No data are available in pre-term neonates.
Croatian: 1,5 ml (15 mg) dvaput na dan *Nema dostupnih podataka o primjeni u nedonoščadi.
English: Table 9 displays pharmacokinetic parameters for neonates in Cohort 2 at birth and at 2 weeks of age.
Croatian: Tablica 9 prikazuje farmakokinetičke parametre za novorođenčad u Kohorti 2 nakon rođenja i u dobi od 2 tjedna.
English: Note before adding Isentress:
Croatian: Napomena prije dodavanja lijeka Isentress:
English: For details on preparation and administration of the suspension, see section 6.6.
Croatian: Za pojedinosti o pripremi i primjeni suspenzije vidjeti dio 6.6.
English: This may mean that the HIV virus will develop resistance to Isentress and become harder to treat.
Croatian: To može značiti da je virus HIV-a postao otporan na Isentress i postaje ga teže liječiti.
English: ‡ AUC0-24hr (N = 24); C24hr §AUC0-12hr; C12hr
Croatian: ‡AUC0-24h (N = 24); C24h §AUC0-12h; C12h
English: Dizziness may influence some patients' ability to drive and use machines (see section 4.8).
Croatian: Omaglica može utjecati na sposobnost nekih bolesnika da upravljaju vozilima i rade sa strojevima (vidjeti dio 4.8).
English: What Isentress is and what it is used for
Croatian: Što je Isentress i za što se koristi
English: Keep a list of all your medicines to show your doctor and pharmacist.
Croatian: Napravite popis svih lijekova koje uzimate kako biste ga mogli pokazati svom liječniku ili ljekarniku.
English: Tell your doctor if you have a history of depression or psychiatric illness.
Croatian: Obavijestite liječnika ako ste imali depresiju ili neku psihijatrijsku bolest.
English: Therefore ISENTRESS should be used with caution in this population.
Croatian: Stoga ISENTRESS u ovoj populaciji treba primjenjivati uz oprez.
English: (chelation of metal ions)
Croatian: (kelacija iona metala)
English: Isentress is used to treat adults, adolescents, children, toddlers and infants who are infected by HIV and to treat newborn babies exposed to HIV-1 infection from the mother.
Croatian: Isentress se primjenjuje za liječenje odraslih, adolescenata, djece, male djece i dojenčadi koji su zaraženi HIV-om te za liječenje novorođenčadi izložene infekciji virusom HIV-1 preko majke.
English: Check to make sure the granules are mixed.
Croatian: Provjerite jesu li se granule dobro promiješale.
English: Talk to your doctor, pharmacist or nurse before taking Isentress.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Isentress.
English: When used with other medicines, Isentress may reduce the amount of HIV in your blood (this is called your "viral load") and increase your CD4-cell count (a type of white blood cells that plays an important role in maintaining a healthy immune system to help fight infection).
Croatian: Kada se primjenjuje s drugim lijekovima, Isentress može smanjiti količinu HIV-a u krvi (ta se količina naziva "virusno opterećenje") i povećati broj CD4 stanica (vrste bijelih krvnih stanica koje imaju važnu ulogu u održavanju zdravog imunološkog sustava kako bi se mogao boriti protiv zaraze).
English: You must give to your child within 30 minutes of mixing.
Croatian: Morate ih dati djetetu unutar 30 minuta nakon pripreme (miješanja).
English: • feeling anxious; feeling of confusion; depressed mood; mood changes; panic attack
Croatian: • osjećaj tjeskobnosti; osjećaj smetenosti; depresivno raspoloženje; promjene raspoloženja; napadaj panike
English: If it is less than 10 mL, put the tip back into the water and pull back on the plunger until you get to the 10 mL mark.
Croatian: Ako je manja od 10 ml, ponovno uronite vrh štrcaljke u vodu i povlačite klip dok ne dođete do oznake za 10 ml.
English: Other medicines and Isentress
Croatian: Drugi lijekovi i Isentress
English: • accumulation of fat in the liver
Croatian: • nakupljanje masnoće u jetri
English: Food appears to increase pharmacokinetic variability relative to fasting.
Croatian: Čini se da hrana povećava farmakokinetičku varijabilnost lijeka u odnosu na primjenu natašte.
English: Gently swirl the mixing cup for 45 seconds in a circular motion to mix the granules and water.
Croatian: Nježno vrtite čašu za miješanje kružnim pokretima tijekom 45 sekundi kako bi se granule pomiješale s vodom.
English: It is important that your child takes all of the prescribed dose (a little left in the syringe tip is OK).
Croatian: Važno je da dijete dobije cijelu propisanu dozu (u redu je ako u vrhu štrcaljke preostane mala količina lijeka).
English: Raltegravir may be administered with or without food.
Croatian: Raltegravir se može primijeniti s hranom ili bez nje.
English: • Store in the original package with the bottle tightly closed.
Croatian: • Čuvati u originalnom pakiranju, u čvrsto zatvorenoj boci.
English: 400 mg twice daily 18 14.1 (121 %)
Croatian: 400 mg dvaput na dan 18 14,1 (121%)
English: • When your supply of Isentress starts to run low, get more from your doctor or pharmacy.
Croatian: • Kada se Vaša zaliha lijeka Isentress približi kraju, nabavite novu količinu od svog liječnika ili ljekarnika.
English: HIV genomes that fail to integrate cannot direct the production of new infectious viral particles, so inhibiting integration prevents propagation of the viral infection.
Croatian: Genomi HIV-a koji se ne uspiju integrirati ne mogu upravljati stvaranjem novih infektivnih čestica virusa tako da inhibicija integracije sprječava širenje virusne infekcije.
English: Sensitivity score (GSS)
Croatian: Indeks genotipske osjetljivosti (GSS)
English: • atazanavir (an antiretroviral medication)
Croatian: • atazanavir (antiretrovirusni lijek)
English: These results indicate that raltegravir is not an inducer or inhibitor of CYP3A4, and raltegravir is thus not anticipated to affect the pharmacokinetics of medicinal products which are CYP3A4 substrates.
Croatian: Ovi rezultati pokazuju da raltegravir nije ni induktor ni inhibitor CYP3A4 i stoga se ne očekuje da utječe na farmakokinetiku lijekova koji su supstrati CYP3A4.
English: What Isentress looks like and contents of the pack
Croatian: Kako Isentress izgleda i sadržaj pakiranja
English: Sixteen (16) neonates received 2 doses of ISENTRESS in first 2 weeks of life, and 26 neonates received 6 weeks of daily dosing; all were followed for 24 weeks.
Croatian: Šesnaest (16) novorođenčadi primilo je 2 doze lijeka ISENTRESS u prva 2 tjedna života, dok je 26 novorođenčadi primalo lijek svakodnevno tijekom 6 tjedana; sva je novorođenčad bila praćena 24 tjedna.
English: Available pharmacodynamics/toxicological data in animals have shown excretion of raltegravir/metabolites in milk (for details see section 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci prikupljeni u životinja pokazali su izlučivanje raltegravira/metabolita u mlijeko (za detaljnije informacije vidjeti dio 5.3).
English: HIV-1 Exposed Neonates
Croatian: Novorođenčad izložena virusu HIV-1
English: The kit has an extra cup and set of syringes in case one is lost or damaged.
Croatian: Komplet sadrži i jednu dodatnu čašu te rezervni set štrcaljki za slučaj da se jedna izgubi ili ošteti.
English: Therefore, no dose adjustment is required.
Croatian: Stoga nije potrebno prilagođavati dozu.
English: The dose recommended for neonates less than 4 weeks of age takes into consideration the rapidly increasing UGT1A1 activity and drug clearance from birth to 4 weeks of age.
Croatian: Kod preporučene doze za novorođenčad mlađu od 4 tjedna uzeto je u obzir brzo povećanje aktivnosti enzima UGT1A1 i klirensa lijeka od rođenja do 4. tjedna života.
English: Non-clinical toxicology studies, including conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, developmental toxicity and juvenile toxicity, have been conducted with raltegravir in mice, rats, dogs and rabbits.
Croatian: Neklinička toksikološka ispitivanja raltegravira, uključujući konvencionalna ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, razvojne toksičnosti i juvenilne toksičnosti provedena su na miševima, štakorima, psima i kunićima.
English: Pharmacotherapeutic group: antivirals for systemic use, other antivirals, ATC code: J05AX08.
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje sustavnih virusnih infekcija, ostali antivirotici, ATK oznaka: J05AX08.
English: Sources of variability may include differences in co-administration with food and concomitant medicines.
Croatian: Uzroci varijacija mogu uključivati razlike u istodobnoj primjeni s hranom i drugim lijekovima.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Croatian: Značajni primjeri su retinitis izazvan citomegalovirusom, generalizirane i/ili fokalne infekcije mikobakterijama i pneumonija izazvana s Pneumocystis jirovecii (otprije poznatim kao Pneumocystis carinii).
English: • Granules for oral suspension should be given to the patient within 30 minutes of mixing.
Croatian: • Granule za oralnu suspenziju moraju se dati bolesniku unutar 30 minuta nakon pripreme
English: • Make sure the doctor, pharmacist or nurse explains how to mix and give the right dose to your child.
Croatian: • Pobrinite se da Vam liječnik, ljekarnik ili medicinska sestra objasne kako pripremiti točnu dozu i dati je djetetu.
English: Most viruses isolated from patients failing raltegravir had high-level raltegravir resistance resulting from the appearance of two or more mutations in integrase.
Croatian: Većina virusa izoliranih iz bolesnika koji nisu odgovarali na liječenje raltegravirom imala je visok stupanj rezistencije na raltegravir zbog pojave dvije ili više mutacija u integrazi.
English: Do not wash in the dishwasher.
Croatian: Nemojte ih prati u perilici za posuđe.
English: Similar findings were not observed in rabbits.
Croatian: Slični učinci nisu zapaženi kod kunića.
English: • It is very important that you measure the water and Isentress carefully using the correct syringe.
Croatian: • Vrlo je važno da pažljivo odmjerite količinu vode i lijeka Isentress odgovarajućom štrcaljkom.
English: The tablet may also contain trace amount of carnauba wax.
Croatian: Tableta može sadržavati i karnauba vosak u tragovima.
English: Dosing is weight based from birth as specified in Table 1 and Table 2.
Croatian: Doza se od rođenja određuje na temelju tjelesne težine, kako je prikazano u Tablici 1 i Tablici 2.
English: Adults and paediatric population
Croatian: Odrasli i pedijatrijska populacija
English: • rifampicin (a medicine used to treat some infections such as tuberculosis)
Croatian: • rifampicin (lijek za liječenje nekih zaraznih bolesti poput tuberkuloze)
English: 2 years for unopened sachet.
Croatian: Neotvorena vrećica: 2 godine.
English: Be sure to go to all of your doctor's appointments so your child gets the right dose!
Croatian: Obavezno idite na sve liječničke preglede kako bi Vaše dijete dobivalo točnu dozu!
English: Slowly push in the plunger to give the prepared Isentress.
Croatian: Polako pritišćite klip da biste primijenili pripremljeni Isentress.
English: Choose the syringe you need
Croatian: 9. korak: Odaberite štrcaljku koja Vam je potrebna
English: If unable to swallow a tablet, consider the chewable tablet.
Croatian: Ako bolesnik ne može progutati tabletu, razmotrite primjenu tablete za žvakanje.
English: Do not take more Isentress than the doctor recommends.
Croatian: Nemojte uzeti više lijeka Isentress nego što je preporučio liječnik.
English: If you take more Isentress than you should
Croatian: Ako uzmete više lijeka Isentress nego što ste trebali
English: Slowly push the plunger to make the air come out.
Croatian: Polako pritisnite klip da izbacite zrak.
English: Hand wash the syringes, plungers, and mixing cup with warm water and dishwashing soap.
Croatian: Ručno operite štrcaljke, klipove i čašu za miješanje toplom vodom i deterdžentom za pranje posuđa.
English: The absolute bioavailability of raltegravir has not been established.
Croatian: Apsolutna bioraspoloživost raltegravira nije ustanovljena.
English: Therefore, whenever possible, raltegravir should be administered with two other active ARTs to minimise the potential for virological failure and the development of resistance (see section 5.1).
Croatian: Stoga se, kad god je to moguće, raltegravir mora primjenjivati s još dva druga ART-a kako bi se potencijalni izostanak virološkog odgovora i razvoj rezistencije sveli na najmanju moguću mjeru (vidjeti dio 5.1).
English: Instructions for Use for babies
Croatian: Upute za primjenu za novorođenčad
English: As demonstrated in healthy volunteers administered single oral doses of raltegravir in the fasted state, raltegravir is rapidly absorbed with a tmax of approximately 3 hours postdose.
Croatian: Kako je dokazano u zdravih dobrovoljaca koji su primili jednokratnu oralnu dozu raltegravira natašte, raltegravir se brzo apsorbira, uz tmax od približno 3 sata nakon primjene doze.
English: This dose must not exceed 300 mg twice a day.
Croatian: Ta doza ne smije biti viša od 300 mg, dvaput na dan.
English: Adverse reactions Raltegravir (alone or in combination with other ART)
Croatian: Nuspojave Raltegravir (sam ili u kombinaciji s drugim ART-om)
English: Refer to Table 2 for appropriate dosing (see section 5.1).
Croatian: Pogledajte Tablicu 2 za odgovarajuće doziranje (vidjeti dio 5.1).
English: Your doctor can tell you if it is safe to take Isentress with other medicines.
Croatian: Liječnik će Vam reći je li sigurno primjenjivati lijek Isentress s drugim lijekovima.
English: Isentress stops this enzyme from working.
Croatian: Isentress onemogućuje djelovanje tog enzima.
English: • mental disorder
Croatian: • mentalni poremećaj