FrancophonIA/ELRC3.0 huggingface dataset:
English: Epivir also contains preservatives (parahydroxybenzoates) which may cause allergic reactions (possibly delayed).
Croatian: Epivir također sadrži i konzervanse (parahidroksibenzoati) koji mogu izazvati alergijske reakcije (moguće i reakcije odgođene preosjetljivosti).
English: This difference in suppression rates between tablets and solutions remained through Week 96 with once daily dosing.
Croatian: Ta razlika u stopama supresije između tableta i otopina održala se sve do 96. tjedna uz doziranje jedanput na dan.
English: • a low red blood cell count (anaemia) or low white blood cell count (neutropenia)
Croatian: • nizak broj crvenih krvnih stanica (anemija) ili bijelih krvnih stanica (neutropenija)
English: You may still develop other infections and illnesses linked to HIV infection.
Croatian: Ipak, mogu se javiti infekcije i bolesti povezane s infekcijom HIV-om.
English: Some people taking medicines for HIV infection develop other conditions, which can be serious.
Croatian: U nekih se ljudi koji uzimaju lijekove za infekciju HIV-om mogu razviti i druga stanja, koja mogu biti ozbiljna.
English: HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Croatian: Infekcija HIV-om širi se spolnim putem s nekim tko ima infekciju ili putem zaražene krvi (primjerice korištenjem zaraženih injekcijskih igala).
English: Epivir is not recommended for use as monotherapy.
Croatian: Epivir se ne preporučuje koristiti u monoterapiji.
English: If you forget to take Epivir
Croatian: Ako ste zaboravili uzeti Epivir
English: Turn the bottle the correct way up.
Croatian: Okrenite bočicu u ispravan položaj prema gore.
English: Put the syringe into your mouth, placing the tip of the syringe against the inside of your cheek.
Croatian: Stavite štrcaljku u usta, tako da vrh štrcaljke dodiruje unutrašnju stranu Vašeg obraza.
English: Important information about some of the ingredients of Epivir
Croatian: Važne informacije o nekim sastojcima Epivir oralne otopine
English: Children from three months of age: As an accurate dosage cannot be achieved with the 300 mg nonscored tablet formulation in this patient population, it is recommended that the Epivir 150 mg scored tablet formulation is used and the corresponding recommended dosage instructions are followed.
Croatian: Djeca od navršena 3 mjeseca: Budući da se u ovoj populaciji bolesnika točna doza ne može postići tabletom od 300 mg bez razdjelnog ureza, preporučuje se koristiti Epivir tabletu od 150 mg s razdjelnom crtom i slijediti odgovarajuće upute za preporučeno doziranje.
English: Close the bottle tightly with the cap, leaving the adaptor in place.
Croatian: Zatvorite bočicu čvrsto sa zatvaračem, ostavljajući nastavak na mjestu.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Croatian: Ovakve reakcije su tipično zabilježene u prvih nekoliko tjedana ili mjeseci nakon uvođenja kombinacijskog antiretrovirusnog liječenja.
English: Pregnancy: Following oral administration, lamivudine pharmacokinetics in late-pregnancy were similar to non-pregnant women.
Croatian: Trudnoća: Nakon peroralne primjene farmakokinetika lamivudina u kasnoj trudnoći bila je slična kao i u žena koje nisu bile trudne.
English: Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV).
Croatian: Lamivudin je analog nukleozida koji djeluje protiv virusa humane imunodeficijencije (HIV) i virusa hepatitisa B (HBV).
English: Date of first authorisation: 8 August 1996 Date of last renewal: 28 July 2006
Croatian: Datum posljednje obnove odobrenja: 28. srpnja 2006.
English: The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when the main route of elimination is active renal secretion via the organic cationic transport system e.g. trimethoprim.
Croatian: Treba razmotriti moguće interakcije s drugim istodobno primijenjenim lijekovima, osobito onima čiji je glavni put eliminacije aktivna renalna sekrecija putem organskog kationskog transportnog sustava, kao što je trimetoprim.
English: If you take more Epivir than you should
Croatian: Ako ste uzeli više lijeka Epivir nego što ste trebali
English: The mean (CV) AUC over a dosing interval of 12 hours is 4.7 µg.h/ml (18%).
Croatian: Srednja vrijednost (CV) AUC tijekom intervala doziranja od 12 sati je 4,7 µg.h/ml (18%).
English: The active moiety, intracellular lamivudine triphosphate, has a prolonged terminal half-life in the cell (16 to 19 hours) compared to the plasma lamivudine half-life (5 to 7 hours).
Croatian: Aktivni metabolit, intracelularni lamivudin trifosfat, ima produljeni poluživot u stanici (16 do 19 sati) u usporedbi s poluživotom lamivudina u plazmi (5 do 7 sati).
English: 3 years
Croatian: 3 godina
English: Due to similarities, Epivir should not be administered concomitantly with other cytidine analogues, such as emtricitabine.
Croatian: Epivir se zbog sličnosti ne smije primjenjivati istodobno s drugim citidinskim analozima, poput emtricitabina.
English: This is not considered to be of significance to patient safety and therefore no dosage adjustments are necessary.
Croatian: Budući da se smatra da to nije značajno za sigurnost bolesnika, nije potrebna prilagodba doze.
English: The tablets also contain the following other ingredients:
Croatian: Tablete također sadrže sljedeće pomoćne tvari:
English: • Lactic acidosis (excess lactic acid in the blood)
Croatian: • laktacidoza (nakupljanje mliječne kiseline u krvi)
English: Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Epivir.
Croatian: Ne zaboravite liječniku ili ljekarniku reći da ste počeli uzimati neki novi lijek za vrijeme terapije lijekom Epivir.
English: Epivir may be administered with or without food.
Croatian: Epivir se može primjenjivati s hranom ili bez nje.
English: Pull out syringe plunger until the syringe contains the first part of your full dose.
Croatian: Izvucite klip štrcaljke dok štrcaljka ne sadrži prvu polovicu
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: Ne očekuje se da bi primjena zdrobljenih tableta s malom količinom polutekuće hrane ili tekućine mogla utjecati na farmaceutsku kvalitetu pa se stoga ne očekuje da bi mogla promijeniti klinički učinak.
English: There are no data available on the safety of lamivudine when administered to babies less than three months old.
Croatian: Nisu dostupni podaci o sigurnosti lamivudina primijenjenog bebama mlađim od tri mjeseca.
English: When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Epivir or other medicines you are taking, or an effect of the HIV disease itself.
Croatian: Ako lijek uzimate zbog infekcije HIV-om, teško je reći je li neki simptom nuspojava lijeka Epivir ili drugih lijekova koje uzimate ili se radi o simptomu same bolesti.
English: When concomitant administration is warranted, patients should be monitored clinically.
Croatian: Kad je istodobna primjena tih lijekova neophodna, bolesnike treba klinički pratiti.
English: Patients changing from the twice daily dosing regimen to the once daily dosing regimen should take the recommended once daily dose (as described above) approximately 12 hours after the last twice daily dose, and then continue to take the recommended once daily dose (as described above) approximately every 24 hours.
Croatian: Bolesnici koji prelaze s režima doziranja dvaput na dan na režim doziranja jedanput na dan trebaju uzeti preporučenu dozu za primjenu jedanput na dan (kako je prethodno opisano) približno 12 sati nakon posljednje doze koja se primjenjuje dvaput na dan, a zatim nastaviti uzimati preporučenu dozu za primjenu jedanput na dan (kako je prethodno opisano) približno svaka 24 sata.
English: Other medicinal products (e.g. ranitidine, cimetidine) are eliminated only in part by this mechanism and were shown not to interact with lamivudine.
Croatian: Neki drugi lijekovi (npr. ranitidin, cimetidin) samo se djelomično eliminiraju tim mehanizmom i ne ulaze u interakcije s lamivudinom.
English: When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation.
Croatian: Kad ti ljudi započnu liječenje, mogu se ponovo javiti stare prikrivene infekcije i uzrokovati simptome upale.
English: What Epivir contains
Croatian: Što Epivir sadrži
English: Children from 3 months of age weighing less than 25 kg The dose depends on the child's body weight.
Croatian: Djeca od navršena 3 mjeseca i tjelesne težine manje od 25 kg Doza ovisi o tjelesnoj težini djeteta.
English: If you get any symptoms of infection while you are taking Epivir:
Croatian: Ako zadobijete bilo koji od ovih simptoma infekcije prilikom uzimanja lijeka Epivir:
English: A very rare side effect that may show up in blood tests is: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
Croatian: Vrlo rijetka nuspojava koja se može otkriti krvnim pretragama je: • zatajenje koštane srži u stvaranju novih crvenih krvnih stanica (aplazija crvenih krvnih stanica).
English: Its main mode of action is as a chain terminator of viral reverse transcription.
Croatian: Njegov glavni način djelovanja ogleda se u destrukciji lanca reverzne transkriptaze virusa.
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, alkohola, tešku imunosupresiju, visoki indeks tjelesne mase), opisani su slučajevi osteonekroze, naročito u bolesnika s uznapredovalom HIV bolešću i/ili dugotrajnom izloženošću kombiniranom antiretrovirusnom liječenju.
English: An oral dosing syringe and a plastic adapter for the bottle is included in the pack.
Croatian: Štrcaljka za oralno doziranje i plastični nastavak za bočicu su uključeni u pakiranje.
English: Epivir oral solution given concomitantly with sorbitol-containing medicines should be used only when an all-tablet regimen cannot be used and the benefits of treatment outweigh possible risks including lower virological suppression.
Croatian: Epivir oralnu otopinu koja se daje istodobno s lijekovima koji sadrže sorbitol treba koristiti samo kada se ne mogu koristiti samo tablete tijekom cjelokupnog liječenja i kada koristi liječenja nadilaze moguće rizike, uključujući nižu stopu virusne supresije.
English: Glomerular filtration estimates suggests that to achieve similar adult and paediatric exposure, an appropriate dose for children aged six weeks and older could be 8 mg/kg/day.
Croatian: Procjene glomerularne filtracije ukazuju da u cilju postizanja izloženosti slične onoj u odraslih i starije djece, prikladna doza za djecu u dobi od 6 tjedana i više može iznositi 8 mg/kg/dan.
English: Frequencies are defined as 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), very rare (<1/10,000).
Croatian: Nuspojave za koje se smatra da mogu biti povezane s liječenjem navedene su prema klasifikaciji organskih sustava i klasificirane prema učestalosti pojavljivanja kao: vrlo česte (≥ 1/10), česte (≥ 1/100 i < 1/10), manje česte (≥ 1/1000 i <1/100), rijetke (≥ 1/10 000 i < 1/1000), vrlo rijetke (< 1/10 000).
English: Bottle contents: 240 ml oral solution
Croatian: Sadržaj bočice: 240 ml oralne otopine
English: It is important to read the information later in this section under ‘Other possible side effects of combination therapy for HIV'.
Croatian: Važno je pročitati informacije u nastavku teksta pod naslovom „Druge moguće nuspojave kombinirane terapije za HIV“.
English: As the in vitro mutagenic activity of lamivudine could not be confirmed in in vivo tests, it is concluded that lamivudine should not represent a genotoxic hazard to patients undergoing treatment.
Croatian: Budući da se mutageni učinak in vitro ne može potvrditi in vivo testovima, zaključeno je da lamivudin ne bi trebao predstavljati genotoksičnu opasnost za bolesnika.
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 je pravilo da se pri donošenju odluke o primjeni antiretrovirusnih lijekova za liječenje HIV infekcije u trudnica, a time i za smanjenje rizika od vertikalnog prijenosa HIV-a na novorođenče, moraju uzeti u obzir i podaci prikupljeni u ispitivanjima na životinjama i kliničko iskustvo s trudnicama.
English: Treatment with Epivir should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur.
Croatian: Primjenu lijeka Epivir treba odmah prekinuti ako nastupe klinički znaci, simptomi ili poremećaji laboratorijskih vrijednosti koje upućuju na pankreatitis.
English: Opportunistic infections: Patients receiving Epivir or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with associated HIV diseases.
Croatian: Oportunističke infekcije: Bolesnici koji dobivaju Epivir ili bilo koji drugi antiretrovirusni lijek mogu i dalje biti skloni razvoju oportunističkih infekcija kao i ostalih komplikacija infekcije HIV-om te stoga trebaju ostati pod strogim nadzorom liječnika s iskustvom u liječenju bolesti povezanih s HIV-om.
English: If you cannot swallow the tablet whole, you may crush and combine it with a small amount of food or drink, and take all the dose immediately.
Croatian: Ako tabletu ne možete progutati cijelu, možete je zdrobiti i pomiješati s manjom količinom hrane ili pića te odmah uzeti cijelu dozu.
English: Lamivudine has no effect on the pharmacokinetics of trimethoprim or sulfamethoxazole.
Croatian: Lamivudin ne utječe na farmakokinetiku trimetoprima ili sulfametoksazola.
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: Ako bolesnik istodobno prima neki protuvirusni lijek za liječenje hepatitisa B ili C, molimo proučite odgovarajuće informacije i za te lijekove.
English: Co-administration of lamivudine with high doses of co-trimoxazole for the treatment of Pneumocystis jirovecii pneumonia (PCP) and toxoplasmosis should be avoided.
Croatian: Treba izbjegavati istodobnu primjenu lamivudina s visokim dozama kotrimoksazola u liječenju pneumonije uzrokovane Pneumocystis jirovecii (PJP) i toksoplazmoze.
English: Each 15 ml dose contains 44.1 mg sodium.
Croatian: Jedna doza od 15 ml sadrži 44,1 mg natrija.
English: The nucleoside analogues (e.g. didanosine) like zidovudine, are not eliminated by this mechanism and are unlikely to interact with lamivudine.
Croatian: Analozi nukleozida kao što je zidovudin (npr. didanozin ) ne eliminiraju se putem tog mehanizma i nisu vjerojatne njihove interakcije s lamivudinom.
English: Talk to your doctor if this applies to you or your child.
Croatian: Razgovarajte sa svojim liječnikom ako se to odnosi na Vas ili Vaše dijete.
English: Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.
Croatian: Obavijestite svog liječnika ili ljekarnika ako neka nuspojava postane teža ili zabrinjavajuća ili primijetite neku nuspojavu koja nije navedena u ovoj uputi.
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: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP).
Croatian: Relevantni primjeri uključuju citomegalovirusom izazvani retinitis, generalizirane i/ili fokalne infekcije mikobakterijama i pneumoniju izazvanu s Pneumocystis jirovecii (često se naziva PJP).
English: If you are a diabetic, please note that each dose (150 mg = 15 ml) contains 3 g sugar.
Croatian: Ako ste dijabetičar, imajte na umu da svaka doza (150 mg=15 ml) sadrži 3 g šećera.
English: Although not studied, the same effect would be expected with other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol (see section 4.5)).
Croatian: Iako nije ispitivano, isti učinak se očekuje s drugim poliolima osmotskog djelovanja ili monosaharidnim alkoholima (npr. ksilitol, manitol, laktitol, maltitol (vidjeti dio 4.5)).
English: If overdosage occurs the patient should be monitored, and standard supportive treatment applied as required.
Croatian: U slučaju predoziranja potrebno je pratiti bolesnika i primjenjivati standardne suportivne mjere.
English: PVC/aluminium foil blister packs:
Croatian: Blister pakiranja od PVC/aluminijske folije:
English: • irritated or runny nose
Croatian: • nadražen nos ili curenje iz nosa
English: • other medicines containing lamivudine, (used to treat HIV infection or hepatitis B infection)
Croatian: • drugi lijekovi koji sadrže lamivudin (koji se primjenjuju za liječenje infekcija HIV-om ili hepatitisom B)
English: Pharmacotherapeutic group: nucleoside analogue, ATC Code: J05AF05.
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: analog nukleozida, ATK oznaka: J05AF05.
English: HDPE bottles :
Croatian: HDPE bočice:
English: Epivir is also available as an oral solution for children over three months of age and who weigh less than 14 kg or for patients who are unable to swallow tablets (see section 4.4).
Croatian: Epivir je dostupan i u obliku oralne otopine za djecu stariju od tri mjeseca i tjelesne težine manje od 14 kg ili za bolesnike koji ne mogu progutati tablete (vidjeti dio 4.4).
English: The clinical significance of these findings is unknown.
Croatian: Klinički značaj tih nalaza nije poznat.
English: Weight and metabolic parameters: An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Croatian: Tjelesna težina i metabolički parametri: Povećanje tjelesne težine i povišene razine lipida i glukoze u krvi mogu se pojaviti tijekom antiretrovirusne terapije.
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited binding to the major plasma protein albumin (< 16% - 36% to serum albumin in in vitro studies).
Croatian: U terapijskom rasponu doziranja lamivudin ima linearnu farmakokinetiku i slabo se veže na albumin, glavni protein u plazmi (<16 - 36% na serumski albumin u in vitro ispitivanjima).
English: Lamivudine metabolism does not involve CYP3A, making interactions with medicinal products metabolised by this system (e.g. PIs) unlikely.
Croatian: Metabolizam lamivudina ne uključuje CYP3A te stoga nisu vjerojatne interakcije s lijekovima koji se metaboliziraju putem tog sustava (npr. inhibitori proteaze).
English: Take special care with Epivir
Croatian: Budite posebno oprezni s lijekom Epivir
English: It is recommended that HIV infected women 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 kom slučaju ne doje kako bi se izbjegao prijenos HIV-a.
English: • liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis).
Croatian: • jetreni poremećaji, poput žutice, povećane ili masne jetre, upale (hepatitis).
English: The 300 mg tablet is only suitable for the once a day regimen.
Croatian: Tableta od 300 mg prikladna je samo za doziranje jednom na dan.
English: In vitro studies indicate that zidovudine-resistant virus isolates can become zidovudine sensitive when they simultaneously acquire resistance to lamivudine.
Croatian: In vitro studije pokazuju da zidovudin-rezistentni izolati virusa mogu postati osjetljivi na zidovudin istodobno kada postanu rezistentni na lamivudin.
English: The 150 mg tablet is bioequivalent and dose proportional to the 300 mg tablet with respect to AUC, Cmax, and tmax.
Croatian: Tableta od 150 mg je bioekvivalentna i proporcionalna dozi tablete od 300 mg s obzirom na AUC∞, Cmax i tmax.
English: Clinical trial evidence from paediatric patients receiving lamivudine with other antiretroviral drugs (abacavir, nevirapine/efavirenz or zidovudine) has shown that the resistance profile observed in paediatric patients is similar to that observed in adults, in terms of the genotypic substitutions detected and their relative frequency.
Croatian: Dokazi iz kliničkih ispitivanja s pedijatrijskim bolesnicima koji su primali lamivudin zajedno s drugim antiretrovirusnim lijekovima (abakavirom, nevirapinom/efavirenzom ili zidovudinom) pokazali su da je profil rezistencije primijećen u pedijatrijskih bolesnika sličan onome zabilježenome u odraslih s obzirom na otkrivene genotipske supstitucije i njihovu relativnu učestalost.
English: At the time of randomization to once daily vs twice daily dosing (Week 0), those patients who had received tablet formulations had a higher rate of viral load suppression than those who had received any solution formulations at any time.
Croatian: U vrijeme randomizacije za primjenu lijeka jedanput odnosno dvaput na dan (0. tjedan), bolesnici koji su primali lijek u obliku tableta imali su višu stopu supresije virusnog opterećenja od onih koji su u bilo kojem trenutku primali bilo koju otopinu.
English: Lamivudine at a dose of 100 mg once daily has also been shown to be effective for the treatment of adult patients with chronic HBV infection (for details of clinical studies, see the prescribing information for Zeffix).
Croatian: Lamivudin u dozi od 100 mg jedanput na dan pokazao se učinkovitim u liječenju odraslih bolesnika s kroničnom hepatitis B infekcijom (za detalje o kliničkim ispitivanjima, vidjeti upute za propisivanje lijeka Zeffix).
English: However, for the treatment of HIV infection, only a 300 mg daily dose of lamivudine (in combination with other antiretroviral agents) has been shown to be efficacious.
Croatian: Međutim, za liječenje HIV infekcije djelotvorna je jedino doza od 300 mg na dan (u kombinaciji s drugim antiretrovirusnim lijekovima).
English: Genotypic resistance analyses were conducted on samples with plasma HIV-1 RNA >1000 copies/ml.
Croatian: Provedene su analize genotipske rezistencije na uzorcima s količinom HIV-1 RNK u plazmi > 1000 kopija/ml.
English: In clinical trials, lamivudine in combination with zidovudine has been shown to reduce HIV-1 viral load and increase CD4 cell count.
Croatian: U kliničkim ispitivanjima lamivudin je u kombinaciji sa zidovudinom smanjio broj kopija HIV-1 virusa i povećao broj CD4 stanica.
English: • medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol,
Croatian: • lijekovi koji sadrže sorbitol (obično tekućine) i druge šećerne alkohole (poput ksilitola,
English: A fertility study in rats has shown that lamivudine had no effect on male or female fertility.
Croatian: Ispitivanje plodnosti na štakorima pokazalo je da lamivudin ne utječe na plodnost mužjaka ni ženki.