FrancophonIA/ELRC3.0 huggingface dataset:
English: Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Lamivudine/Zidovudine Teva.
Croatian: Zapamtite da svakako obavijestite svog liječnika ili ljekarnika ako započnete uzimati nove lijekove dok uzimate istodobno Lamivudin/Zidovudin Teva.
English: Do not use this medicine after the expiry date which is stated on the container or carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na spremniku ili kutiji i blisteru iza oznake „EXP“.
English: Haematological parameters should therefore be carefully monitored (see section 4.3) in patients receiving Lamivudine/Zidovudine Teva.
Croatian: Stoga treba pažljivo pratiti hematološke parametre (vidjeti dio 4.3) u bolesnika koji dobivaju Lamivudin/Zidovudin Teva.
English: If you cannot swallow the tablet(s), you may crush and combine them with a small amount of food or drink and take all the dose immediately.
Croatian: Ako ne možete progutati tabletu, možete je izdrobiti i pomiješati s malom količinom hrane ili tekućine, te cijelu dozu odmah progutati.
English: • feeling depressed or anxious, not being able to concentrate, feeling drowsy
Croatian: • osjećaj depresije ili anksioznosti, nemogućnost koncentracije, pospanost
English: Exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated.
Croatian: Egzacerbacija anemije zbog ribavirina bila je uočena kada je zidovudin bio dio terapijskog režima kojim se liječio HIV iako se točan mehanizam još treba ustanoviti.
English: If you have taken Lamivudine/Zidovudine Teva during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Croatian: Ako ste Lamivudin/Zidovudin Teva uzimali tijekom trudnoće, postoji mogućnost da liječnik zatraži redovito provođenje pretraga krvi i drugih dijagnostičkih pretraga kako bi pratio razvoj vašega djeteta.
English: Administration of crushed tablets with a small amount of semi-solid food or liquid would not be expected to have an impact on the pharmaceutical quality, and would therefore not be expected to alter the clinical effect.
Croatian: Primjena drobljene tablete s malom količinom kašaste hrane ili tekućine, ne bi trebala utjecati na farmakološku djelotvornost lijeka, pa se n e očekuje niti promjena kliničkog učinka.
English: Viruses acquire phenotypic resistance to thymidine analogues through the combination of mutations at codons 41 and 215 or by the accumulation of at least four of the six mutations.
Croatian: Virusi posjeduju fenotipsku rezistenciju na analoge timidina putem kombinacije mutacija na kodonima 41 i 215 ili akumulacije najmanje 4 od 6 mutacija.
English: In a second study, mice were administered zidovudine at doses up to 40 mg/kg for 24 months, with exposure beginning prenatally on gestation day 10.
Croatian: U drugom ispitivanju su miševima u razdoblju od 24 mjeseca davali zidovudim u dozama do 40 mg/kg, počevši prenatalno od 10. dana gestacije.
English: Lamivudine: AUC ↑40% Trimethoprim: AUC ↔ Sulfamethoxazole: AUC ↔ (organic cation transporter inhibition)
Croatian: lamivudin: AUC ↑40% trimetoprim: AUC ↔ sulfametoksazol: AUC ↔ (inhibicija transportera organskog kationa)
English: To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing.
Croatian: Kako bi se uzela cijela propisana doza, tabletu (tablete) treba progutati bez drobljenja.
English: In one study, by the US National Cancer Institute, zidovudine was administered at maximum tolerated doses to pregnant mice from day 12 to 18 of gestation.
Croatian: U jednom ispitivanju koje je proveo američki Nacionalni institut za rak, zidovudin je primijenjen u najvećoj podnošljivoj dozi skotnim ženkama od 12. do 18. dana gestacije.
English: • medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly.
Croatian: • lijekove (obično u tekućem obliku) koji sadrže sorbitol i druge šećerne alkohole (poput ksilitola, manitola, laktitola ili maltitola), ako se uzimaju redovito.
English: 80 Mogilska St.
Croatian: Zaklady Farmaceutyczne S.A. 80 Mogilska St.
English: OPA/Alu/PVC Aluminium blisters
Croatian: Blisteri: OPA/Alu/PVC aluminij blisteri
English: Children who weigh between 14 and 21 kg
Croatian: Djeca s tjelesnom težinom između 14 kg i 21 kg
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Podrobnije informacije o ovom lijeku dostupne su na web stranicama Europske agencije za lijekove http://www.ema.europa.eu.
English: It is important to read the information later in this section under ‘Other possible side effects of combination therapy for HIV'.
Croatian: Vrlo je važno pročitati informacije u dijelu “Ostale moguće nuspojave u kombiniranoj terapiji za HIV”.
English: Lamivudine/Zidovudine Teva tablets should not be used for children weighing less than 14 kg, since doses cannot be appropriately adjusted for the weight of the child.
Croatian: Lamivudin/Zidovudin Teva tablete ne bi trebalo primjenjivati u djece s tjelesnom težinom manjom od 14 kg zbog nemogućnosti odgovarajuće prilagodbe doze prema tjelesnoj težini djeteta.
English: For these patients and for patients, who are unable to swallow tablets, oral solutions of lamivudine and zidovudine are available.
Croatian: Za ove bolesnike i one koji ne mogu progutati tabletu, dostupne su oralne otopine lamivudina i zidovudina.
English: In vitro lamivudine inhibits the intracellular phosphorylation of cladribine leading to a potential risk of cladribine loss of efficacy in case of combination in the clinical setting.
Croatian: In vitro lamivudin inhibira unutarstaničnu fosforilaciju kladribina što dovodi do potencijalne opasnosti gubitka djelotvornosti kladribina u slučaju kombinacije u kliničkom okruženju.
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.
Croatian: Opće pravilo je, da se kod odluke za primjenom antiretrovirusnih lijekova za liječenje infekcije HIV-a u trudnica i posljedično za smanjenje rizika vertikalnog prijenosa HIV-a na novorođenčad, trebaju uzeti u obzir i podaci dobiveni na životinjama kao i kliničko iskustvo kod trudnica.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Croatian: U slučaju da bolesnik istodobno prima neku antivirusnu terapiju za hepatitis B ili C, molimo pogledajte također odgovarajuće Sažetke opisa svojstava lijeka za te lijekove.
English: For patients who are unable to swallow tablets, tablets may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see section 5.2).
Croatian: Bolesnicima koji tablete ne mogu progutati, dozvoljeno je tabletu zdrobiti i pomiješati s malom količinom kašaste hrane ili tekućine, te sve zajedno odmah progutati (vidjeti dio 5.2).
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Croatian: Liječenje treba započeti liječnik s iskustvom u liječenju HIV infekcije.
English: Lamivudine was not teratogenic in animal studies.
Croatian: Lamivudin nije pokazao teratogeni učinak u ispitivanjima na životinjama.
English: Zidovudine is well absorbed from the gut and at all dose levels studied in adults and children, the bioavailability was between 60-74 % with a mean of 65 %.
Croatian: Zidovudin se dobro apsorbira iz crijeva i u svim ispitivanim dozama, u djece i odraslih, bioraspoloživost se kretala između 60 i 74%, sa srednjom vrijednosti od 65%.
English: Lactic acidosis is a rare but serious side effect
Croatian: Laktacidoza je rijetka, ali ozbiljna nuspojava
English: Their main modes of action are as chain terminators of viral reverse transcription.
Croatian: Njihov glavni način djelovanja je prekidanje lanca reverzne transkripcije virusa.
English: • probenecid, to treat gout and similar conditions, and given with some antibiotics to make them more effective
Croatian: • probenecid, za liječenje gihta i sličnih stanja, uz terapiju antibioticima radi bolje efikasnosti
English: The frequency of this is unknown (see section 4.4).
Croatian: Učestalost navedenog nije poznata (vidjeti dio 4.4).
English: • other medicinal products containing lamivudine, to treat HIV infection or hepatitis B infection
Croatian: • drugi lijekovi koji sadrže lamivudin, za liječenje infekcija HIV-om ili infekcije hepatitisa B
English: The carcinogenic potential of a combination of lamivudine and zidovudine has not been tested.
Croatian: Kancerogeni potencijal kombinacije lamivudina i zidovudina nije ispitivan.
English: HIV-1 resistance to lamivudine involves the development of a M184V amino acid change close to the active site of the viral reverse transcriptase (RT).
Croatian: Rezistencija HIV-1 na lamivudin uključuje promjenu aminokiseline M184V u blizini aktivnog mjesta virusne reverzne transkriptaze (RT).
English: People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections).
Croatian: Bolesnici s uznapredovalom HIV infekcijom (SIDA) imaju oslabljeni imunološki sustav, te su skloniji razvoju ozbiljnih infekcija (oportunističkih infekcija).
English: High doses of trimethoprim/ sulfamethoxazole for the treatment of Pneumocystis jirovecii pneumonia (PCP) and toxoplasmosis have not been studied and should be avoided.
Croatian: Visoke doze trimetoprima/ sulfametoksazola za liječenje Pneumocystis jirovecii pneumonije i toksoplazmoze nisu proučavane, te bi ih trebalo izbjegavati
English: In addition, two transplacental carcinogenicity studies have been conducted in mice.
Croatian: Dodatno, u miševa su provedena dva ispitivanja transplacentarne kancerogenosti.
English: Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products (e.g. systemic pentamidine, dapsone, pyrimethamine, co-trimoxazole, amphotericin, flucytosine, ganciclovir, interferon, vincristine, vinblastine and doxorubicin) may also increase the risk of adverse reactions to zidovudine.
Croatian: Istodobna terapija, osobito akutna terapija s potencijalno nefrotoksičnim ili mijelosupresivnim lijekovima (npr. sistemski pentamidin, dapson, pirimetamin, kotrimoksazol, amfotericin, flucitozin, ganciklovir, interferon, vinkristin, vinblastin i doksorubicin) mogu također povisiti rizik za razvoj nuspojava na zidovudin.
English: There is no evidence of added toxicity following concurrent administration of the two compounds.
Croatian: Nema dokaza o dodatnoj toksičnosti uslijed istodobne primjene ova dva lijeka.
English: • if you have kidney disease
Croatian: • ako imate bubrežnu bolest
English: If you forget to take a dose, take it as soon as you remember.
Croatian: Ako ste zaboravili uzeti Lamivudin/Zidovudin Teva Ako zaboravite jednu dozu, uzmite je čim se sjetite i nastavite sa terapijom kao prije.
English: Pharmacokinetics in children: In children over the age of 5-6 months, the pharmacokinetic profile of zidovudine is similar to that in adults.
Croatian: Farmakokinetika u djece: Farmakokinetički profil zidovudina u djece starije od 5-6 mjeseci života je sličan onome u odraslih.
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Croatian: Bolesnike treba uputiti da potraže savjet liječnika u slučaju pojave bolova ili ukočenosti zglobova ili otežane pokretljivosti.
English: Metabolism of lamivudine is a minor route of elimination.
Croatian: Metabolizam predstavlja manje važan put eliminacije lamivudina.
English: Dosages of 180 mg/m2 four times daily in children produced similar systemic exposure (24 hour AUC 40.0 h μM or 10.7 h μg/ml) as doses of 200 mg six times daily in adults (40.7 h μM or 10.9 h μg/ml).
Croatian: 180 mg/m četiri puta dnevno imao je sličnu sistemsku izloženost (24-satna ukupna bioraspoloživost AUC 40,0 h μM ili 10,7 h μg/ml), kao i doza od 200 mg šest puta dnevno primijenjene u odraslih (40,7 h μM ili 10,9 h μg/ml).
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited binding to the major plasma protein albumin (<36 % serum albumin in vitro).
Croatian: Lamivudin pokazuje linearnu farmakokinetiku u rasponu terapijskih doza i ograničeno se veže za glavni protein u plazmi-albumin (<36% serumskog albumina in vitro).
English: • enlarged breasts in men.
Croatian: • povećanje dojki u muškaraca
English: Consider more frequent monitoring of HIV-1 viral load when chronic coadministration cannot be avoided.
Croatian: Razmotrite češće praćenje virusnog opterećenja HIV-1 u slučaju kada se dugotrajna istodobna primjena ne može izbjeći
English: Children who weigh between 21 and 30 kg
Croatian: Djeca s tjelesnom težinom između 21 kg i 30 kg
English: The active ingredients of Lamivudine/Zidovudine Teva may inhibit cellular DNA replication and zidovudine has been shown to be transplacental carcinogen in one animal study (see section 5.3).
Croatian: Djelatne tvari Lamivudina/Zidovudina Teva mogu inhibirati replikaciju stanične DNK i zidovudin se pokazao transplacentalno kancerogen u jednoj studiji na životinjama (vidjeti dio 5.3).
English: Read the information ‘Other possible side effects of combination therapy for HIV' in Section 4 of this leaflet.
Croatian: Pozorno pročitajte informacije “Ostale moguće nuspojave kombinirane terapije HIV-a” u dijelu 4 ove upute.
English: Osteonecrosis: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Croatian: Osteonekroza: Iako se smatra da je etiologija multifaktorijalna (uključujući primjenu kortikosteroida, konzumiranje alkohola, tešku imunosupresiju, visoki indeks tjelesne mase), opisani su slučajevi osteonekroze naročito u bolesnika s uznapredovalom HIV bolešću i/ili dugotrajnom izloženošću kombiniranoj antiretrovirusnoj terapiji.
English: This fat loss, which is most evident in the face, limbs and buttocks, may not be reversible when switching to a zidovudine-free regimen.
Croatian: Taj gubitak masnog tkiva koji je najočitiji na licu, udovima i stražnjici ne mora biti reverzibilan se kad se prijeđe na režim liječenja bez zidovudina.
English: Haemodialysis and peritoneal dialysis appear to have a limited effect on elimination of zidovudine, but enhance the elimination of the glucuronide metabolite.
Croatian: Čini se da hemodijaliza i peritonealna dijaliza imaju ograničen učinak na eliminaciju zidovudina, ali pospješuju eliminaciju metabolita glukuronida.
English: The mean systemic clearance of lamivudine is approximately 0.32 l/h/kg, with predominantly renal clearance (>70 %) via the organic cationic transport system.
Croatian: Prosječna vrijednost sistemskog klirensa lamivudina iznosi oko 0,32 l/h/kg, s predominantnim bubrežnim klirensom (>70%) putem organskog kationskog transportnog sistema.
English: • liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis)
Croatian: • poremećaji jetre, kao što je žutica, povećana ili masna jetra, upala (hepatitis)
English: It is recommended that mothers infected by HIV do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Croatian: Preporučuje se da majke zaražene HIV-om ni u kojem slučaju ne doje, kako bi se izbjegao prijenos virusa HIV-a.
English: Both medicinal products are metabolised intracellularly to their active moieties, lamivudine 5'-triphosphate (TP) and zidovudine 5'-TP respectively.
Croatian: Oba se lijeka u stanicama metaboliziraju u svoje aktivne oblike, lamivudin 5'-trifosfat (TP) i zidovudin 5'-TP.
English: The incidence of neutropenia was also increased in those patients whose neutrophil counts, haemoglobin levels and serum vitamin B12 levels were low at the start of zidovudine therapy.
Croatian: Incidencija n eutropenije b ila je također povećana u onih bolesnika čiji su broj neutrofila, razina hemoglobina i razina vitamina B12 u serumu bili niski na početku liječenja zidovudinom.
English: The available data from both placebo-controlled and open-label studies indicate that the incidence of nausea and other frequently reported clinical adverse events consistently decreases over time during the first few weeks of therapy with zidovudine.
Croatian: Podaci dostupni iz placebom kontroliranih i otvorenih ispitivanja upućuju da se incidencija mučnine i ostalih čestih nuspojava konzistentno smanjuje s vremenom tijekom prvih nekoliko tjedana terapije zidovudinom.
English: Cimetidine eliminated only in part by renal organic cation transport system.
Croatian: Cimetidin se samo djelomično eliminira putem renalnog organsko kationskog transportnog sustava.
English: These include: • clarithromycin, an antibiotic if you are taking clarithromycin, take your dose at least 2 hours before or after you take your Lamivudine/Zidovudine Teva.
Croatian: • klaritromicin, antibiotik ako uzimate klaritromicin, uzmite Vašu dozu 2 sata prije ili poslije uzimanja
English: Rare: Insomnia, paraesthesiae, somnolence, loss of mental acuity, convulsions
Croatian: Rijetko: nesanica, parestezije, somnolencija, gubitak mentalne oštrine, konvulzije
English: • pyrimethamine, to treat malaria and other parasitic infections
Croatian: • pirimetamin, za liječenje malarije i ostalih infekcija parazitima
English: • an increase in the level of liver enzymes
Croatian: • porast razine jetrenih enzima
English: A subsequent intravaginal carcinogenicity study confirmed the hypothesis that the vaginal tumours were the result of long term local exposure of the rodent vaginal epithelium to high concentrations of unmetabolised zidovudine in urine.
Croatian: Daljnje ispitivanje intravaginalne kancerogeneze potvrdila su hipotezu da su vaginalni tumori posljedica dugotrajne lokalne izloženosti vaginalnog epitela glodavaca visokim koncentracijama n emetaboliziranog z idovudina u ur inu.
English: Treatment with zidovudine should be discontinued if there is symptomatic hyperlactatemia and metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Croatian: Liječenje zidovudinom treba prekinuti u slučaju simptomatske hiperlaktatemije i metaboličke acidoze/laktacidoze, progresivne hepatomegalije, ili naglog povećanja razine aminotransferaza.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP).
Croatian: Relevantni primjeri uključuju citomegalovirusni retinitis, generalizirane i/ili fokalne infekcije mikobakterijama i pneumoniju izazvanu s Pneumocystis jiroveci (koja se često naziva PCP).
English: There are no data on their affect on human female fertility.
Croatian: Nema podataka koji govore u prilog takvog oštećenja fertiliteta kod ljudi u žena.
English: These findings should be considered for any child exposed in utero to nucleoside and nucleotide analogues, who presents with severe clinical findings of unknown etiology particularly neurologic findings.
Croatian: Te nalaze treba uzeti u obzir u svakog djeteta koje je in utero bilo izloženo analozima nukleozida i nukleotida, a koje je imalo tešku kliničku sliku nepoznate etiologije, osobito neurološke nalaze.
English: The likelihood of metabolic drug interactions with lamivudine is low due to the small extent of hepatic metabolism (5-10 %) and low plasma binding.
Croatian: Vjerojatnost metaboličkih interakcija lamivudina s drugim lijekovima je vrlo mala zbog niskog opsega metabolizma u jetri (510%) i slabog vezanja za proteine plazme.
English: Dose reduction is required for patients with creatinine clearance ≤50 ml/min (see section 4.2).
Croatian: Preporučuje se smanjenje doze lamivudina u bolesnika s klirensom kreatinina ≤50 ml/min (vidjeti dio 4.2).
English: If you get side effects
Croatian: Ako dobijete nuspojave
English: You need to know about important signs and symptoms to look out for while you are taking Lamivudine/Zidovudine Teva.
Croatian: Zbog toga morate biti upoznati s važnim znakovima i simptomima na koje treba obratiti pozornost za vrijeme uzimanja Lamivudina/Zidovudina Teva.
English: • chest pain; disease of the heart muscle (cardiomyopathy)
Croatian: • bol u prsištu, bolest srčanog mišića (kardiomiopatija)
English: Caution should be exercised when administering zidovudine to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
Croatian: Zidovudin se mora primjenjivati s oprezom u svih bolesnika (osobito u gojaznih žena), u kojih postoje hepatomegalija, hepatitis ili drugi poznati faktori rizika za bolest jetre i steatozu jetre (uključujući neke lijekove i uživanje alkohola).
English: Signs of lactic acidosis include:
Croatian: Znakovi laktacidoze uključuju:
English: The M184V RT mutant shows a <4-fold decrease in susceptibility to didanosine; the clinical significance of these findings is unknown.
Croatian: Mutant M184V RT pokazuje gotovo četverostruko smanjenje osjetljivosti na didanozin, ali kliničko značenje tog nalaza nije poznato.
English: Your doctor will decide if the active substances are suitable for you.
Croatian: Liječnik će odlučiti da li je ovaj lijek pogodan za Vas.
English: In general, lamivudine pharmacokinetics in paediatric patients are similar to adults.
Croatian: Općenito, farmakokinetika lamivudina u pedijatrijskih bolesnika i odraslih je podjednaka.
English: White, capsule shaped, biconvex, film-coated scored tablet - engraved with “L/Z” on one side and “150/300” on the other side.
Croatian: Bijele, bikonveksne filmom obložene tablete oblika kapsule s razdjelnom crtom i utisnutim natpisom „L/Z“ na jednoj strani i „150/300“ na drugoj strani tablete.
English: Some people taking Lamivudine/Zidovudine Teva develop a condition called lactic acidosis, together with an enlarged liver.
Croatian: Pojedine osobe koje uzimaju Lamivudin/Zidovudin Teva, razviju stanje koje se zove laktacidoza, zajedno s povećanjem jetre.
English: For many of these events, it is unclear whether they are related to lamivudine, zidovudine, the wide range of medicinal products used in the management of HIV disease, or as a result of the underlying disease process.
Croatian: U mnogim slučajevima, nije sasvim jasno jesu li one povezane s lamivudinom, zidovudinom, velikim brojem lijekova koji se koriste u liječenju HIV infekcije ili su posljedica same bolesti.
English: The clinically relevant effects of lamivudine and zidovudine in combination are anaemia, neutropenia and leucopenia.
Croatian: Klinički značajni učinci kombinacije lamivudina i zidovudina su anemija, neutropenija i leukopenija.
English: It is recommended that separate preparations of lamivudine and zidovudine should be administered in cases where dosage adjustment is necessary (see section 4.2).
Croatian: Preporučuje se odvojena primjena pripravaka lamivudina i zidovudina u slučajevima kada je potrebno prilagođavanje doze (vidjeti dio 4.2).
English: Early symptoms (symptomatic hyperlactatemia) include benign digestive symptoms (nausea, vomiting and abdominal pain) non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/or deep breathing) or neurological symptoms (including motor weakness).
Croatian: Rani simptomi (simptomatska hiperlaktatemija), uključuju benigne probavne simptome (mučninu, povraćanje i bol u abdomenu), nespecifičnu slabost, gubitak teka, gubitak na tjelesnoj težini, respiratorne simptome (ubrzano i/ili duboko disanje) ili neurološke simptome (uključujući motoričku slabost).