natgillin/translations-raw huggingface dataset:
Studies in animals showed that lamivudine had no effect on fertility (see section 5.3).
Ispitivanja na životinjama pokazala su da lamivudin ne utječe na plodnost (vidjeti dio 5.3).
Lamivudine 4 mg/kg TwiceDaily Dosing Geometric Mean (95% Cl)
Lamivudin 4 mg/kg dvaput na dan -geometrijska srednja vrijednost (95% Cl)
Co-administration of lamivudine with food results in a delay of tmax and a lower C max (decreased by 47%).
Istovremena primjena lamivudina s hranom odgađa tmax i smanjuje Cmax (smanjuje se do 47%).
Cartons containing 240 ml oral solution in a white high density polyethylene (HDPE) bottle, with a child resistant closure.
Kutije sadrže 240 ml oralne otopine u bijeloj bočici od polietilena visoke gustoće (HDPE) sa sigurnosnim zatvaračem za djecu.
The malformative risk is unlikely in humans based on those data.
Na temelju tih podataka može se zaključiti da rizik od malformacija u ljudi nije vjerojatan.
At a therapeutic dose of 300 mg once daily, the mean (CV) steady-state Cmax, Cmin and 24h AUC are 2.0 µg/ml (26%), 0.04 µg/ml (34%) and 8.9 µg.h/ml (21%), respectively.
Pri terapijskoj dozi od 300 mg jedanput na dan, srednja vrijednost (CV) Cmax (u stanju dinamičke ravnoteže) iznosi 2,0 µg/ml (26%), Cmin iznosi 0,04 µg/ml (34%), a 24 satni AUC 8,9 µg.h/ml (21%).
BOTTLE LABEL FOR ORAL SOLUTION
NALJEPNICA ZA BOČICU S ORALNOM OTOPINOM
Excipients: Diabetic patients should be advised that each dose (150 mg = 15 ml) contains 3 g of sucrose.
Pomoćne tvari: Bolesnici s dijabetesom trebaju biti upoznati da svaka doza (150 mg= 15 ml) sadrži 3 g saharoze.
Lamivudine has not been specifically investigated in HIV patients co-infected with HBV.
Nisu provedena posebna ispitivanja lamivudina u bolesnika koji su istodobno zaraženi i HIV-om i HBV-om.
Mitochondrial dysfunction: Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Analozi nukleozida i nukleotida su u in vitro i in vivo uvjetima pokazali sposobnost uzrokovanja različitih stupnjeva mitohondrijskih oštećenja.
Each 300 mg tablet contains 0.756 mg sodium.
Jedna tableta od 300 mg sadrži 0,756 mg natrija.
• cladribine (used to treat hairy cell leukaemia).
• kladribin (koji se primjenjuje za liječenje leukemije srpastih stanica).
Week 0 (after 36 weeks on Treatment) Any solution regimen at any time All tablet based regimen throughouts Week 96
0. tjedan (nakon 36 tjedana liječenja) Bilo koja otopina u bilo kojem trenutku 14/26 (54) Samo tablete tijekom cjelokupnog liječenja
Paediatric population: In a study performed in paediatric patients (see section 5.1 ARROW study), lower rates of virologic suppression and more frequent viral resistance were reported in children receiving the oral solution of Epivir as compared to those receiving the tablet formulation.
Pedijatrijska populacija: U ispitivanju provedenom u pedijatrijskih bolesnika (vidjeti dio 5.1, ispitivanje ARROW), prijavljene su niže stope virusne supresije i češća rezistencija virusa u djece koja su primala Epivir oralnu otopinu u usporedbi s djecom koja su primala tablete.
Children receiving lamivudine oral tablets according to the recommended dosage regimen achieve higher plasma lamivudine exposure than children receiving oral solution because higher mg/kg doses are administered with the tablet formulation and the tablet formulation has higher bioavailability (see section 4.2).
Djeca koja primaju tablete lamivudina za peroralnu primjenu sukladno preporučenom režimu doziranja postižu više razine izloženosti lamivudinu u plazmi nego djeca koja primaju oralnu otopinu jer se tabletama primjenjuju veće doze u mg/kg, a uz to tablete imaju i veću bioraspoloživost (vidjeti dio 4.2).
Week 0 (After ≥36 Weeks on Treatment) Plasma HIV-1 RNA <80 c/ml Risk difference (once daily-twice daily)
0. tjedan (nakon ≥ 36 tjedana liječenja) HIV-1 RNK u plazmi <80 kopija/ml Razlika u riziku (jedanput na dan-dvaput na dan)
Date of first authorisation: 15 November 2001 Date of last renewal: 28 July 2006
Datum prvog odobrenja: 15. studeni 2001.
Children from one year of age: The recommended dose is 0.5 mL/kg (5 mg/kg) twice daily, or 1 mL/kg (10 mg/kg) once daily (see sections 4.4 and 4.5).
Djeca od navršenih godinu dana: Preporučena doza je 0,5 ml/kg (5 mg/kg) dvaput na dan ili 1 ml/kg (10 mg/kg) jedanput na dan (vidjeti dijelove 4.4 i 4.5).
There are no data available on the use of lamivudine in children with renal impairment.
Nema podataka o primjeni lamivudina u djece s bubrežnim oštećenjem.
5 to <15
5 do <15
Based on the assumption that creatinine clearance and lamivudine clearance are correlated similarly in children as in adults; it is recommended that the dosage in children with renal impairment be reduced according to their creatinine clearance by the same proportion as in adults.
Pod pretpostavkom da klirens kreatinina i klirens lamivudina u djece koreliraju s vrijednostima u odraslih; preporučuje se dozu lijeka u djece s oštećenjem bubrega smanjiti shodno njihovom klirensu kreatinina, a proporcionalno smanjenju doze u odraslih bolesnika.
It is metabolised intracellularly to the active moiety, lamivudine 5'- triphosphate.
Lamivudin se intracelularno metabolizira u aktivni lamivudin 5'-trifosfat.
Limited data show that lamivudine penetrates the central nervous system and reaches the cerebrospinal fluid (CSF).
Oskudni podaci pokazuju da lamivudin prodire u SŽS i ulazi u cerebrospinalnu tekućinu.
Skin and subcutaneous tissue disorders Common: Rash, alopecia Rare: Angioedema
Poremećaji kože i potkožnog tkiva Često: osip, alopecija Rijetko: angioedem
The clinical relevance of such findings remains, however, not well defined.
Međutim kliničko značenje ovog nalaza nije definirano.
For patients co-infected with hepatitis who are being treated with lamivudine and subsequently become pregnant, consideration should be given to the possibility of a recurrence of hepatitis on discontinuation of lamivudine.
Za bolesnice s istodobnom infekcijom virusom hepatitisa koje su liječene lamivudinom te su u međuvremenu zatrudnjele, mora se svakako uzeti u obzir mogućnost rekurentne pojave hepatitisa po obustavi liječenja lamivudinom.
Tablet core: microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate Film-coat: hypromellose, titanium dioxide, black iron oxide (E172), macrogol, polysorbate 80 This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Jezgra tablete: mikrokristalična celuloza, natrijev škroboglikolat (bez glutena), magnezijev stearat Film ovojnica: hipromeloza, titanijev dioksid, crni željezov oksid (E172), makrogol, polisorbat 80 Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po doznoj jedinici, tj. zanemarive količine natrija.
In PENTA 15 study, the geometric mean plasma lamivudine AUC(0-24) (95% CI) of the four subjects under 12 months of age who switch from a twice daily to a once daily regimen (see section 5.1) are 10.31 (6.26, 17.0) µg.h/ml in the once-daily dosing and 9.24 (4.66, 18.3) µg.h/ml in the twice-daily dosing.
U ispitivanju PENTA 15, geometrijska srednja vrijednost AUC(0-24) lamivudina u plazmi (95% CI) u četiri ispitanika mlađa od 12 mjeseci koja su s režima primjene dvaput na dan prešla na režim primjene jedanput na dan (vidjeti dio 5.1) iznosila je 10,31 (6,26; 17,0) µg.h/ml uz doziranje jedanput na dan te 9,24 (4,66; 18,3) µg.h/ml uz doziranje dvaput na dan.
Lamivudine is predominately cleared unchanged by renal excretion.
Lamivudin se pretežno izlučuje u nepromijenjenom obliku putem bubrega.
The active ingredient in Epivir is lamivudine.
Djelatna tvar u lijeku Epivir je lamivudin.
The usual dose of Epivir is 0.5 mL/kg (5 mg/kg) twice daily (leaving approximately 12 hours between each dose), or 1 mL/kg (10 mg/kg) once daily.
Uobičajena doza lijeka Epivir je 0,5 ml/kg (5 mg/kg) dvaput na dan (s razmakom od približno 12 sati između doza) ili 1 ml/kg (10 mg/kg) jedanput na dan.
Consider more frequent monitoring of HIV-1 viral load when Epivir is used with chronically-administered, sorbitol-containing medicines [e.g. Ziagen oral solution].
Razmotrite češće praćenje opterećenja virusom HIV-1 kada se lijek Epivir primjenjuje uz kroničnu primjenu lijekova koji sadrže sorbitol [npr.
Epivir contains sucrose.
Epivir sadrži saharozu.
Children weighing 14 to < 20 kg: The recommended dose is 150 mg daily.
Djeca tjelesne težine od 14 kg do < 20 kg: Preporučena doza je 150 mg na dan.
A transplacental genotoxicity study conducted in monkeys compared zidovudine alone with the combination of zidovudine and lamivudine at human-equivalent exposures.
U ispitivanjima transplacentarne genotoksičnosti na majmunima uspoređivan je zidovudin sam i u kombinaciji s lamivudinom i to u dozama izloženosti koje su bile ekvivalentne humanim dozama.
Patients changing between lamivudine tablets and lamivudine oral solution should follow the dosing recommendations that are specific for the formulation (see section 5.2).
Bolesnici koji zamjenjuju lamivudin tablete s lamivudin oralnom otopinom trebali bi slijediti preporuke o doziranju koje su specifične za formulaciju (vidjeti dio 5.2).
No studies on the effects on the ability to drive and use machines have been performed.
Nisu provedena ispitivanja o utjecaju lamivudina na sposobnost upravljanja vozilima i rada sa strojevima.
How to store Epivir
Kako čuvati Epivir
The following adverse reactions have been reported during therapy for HIV disease with Epivir.
Sljedeće su nuspojave zabilježene tijekom liječenja HIV-infekcije lijekom Epivir:
Lamivudine was not genotoxic in vivo at doses that gave plasma concentrations around 40-50 times higher than the anticipated clinical plasma levels.
U in vivo ispitivanjima u dozama koje dovode do koncentracija u plazmi koje su 40 -50 puta više nego predviđene kliničke koncentracije lamivudin nije pokazao genotoksičnost.
Immune Reactivation Syndrome: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Sindrom imunološke reaktivacije: U bolesnika zaraženih HIV-om koji u trenutku započinjanja kombinacijskog antiretrovirusnog liječenja (CART) imaju teški imunološki deficit, može se razviti upalna reakcija na asimptomatske ili rezidualne oportunističke patogene te izazvati ozbiljna klinička stanja ili pogoršanje simptoma.
However it is not clear whether these cases were due to the antiretroviral treatment or to the underlying HIV disease.
Nije utvrđeno je li u tim slučajevima pankreatitis bio posljedica antiretrovirusne terapije ili primarne bolesti.
Whenever possible in children, an all-tablet regimen should preferably be used.
Kad god je to moguće, kod djece treba dati prednost primjeni lijeka u obliku tableta.
Patients changing between lamivudine oral solution and lamivudine tablets should follow the dosing recommendations that are specific for the formulation (see section 5.2)
Bolesnici koji zamjenjuju lamivudin oralnu otopinu s lamivudin tabletama trebali bi slijediti preporuke o doziranju koje su specifične za formulaciju (vidjeti dio 5.2)
Other possible side effects of combination therapy for HIV Combination therapy including Epivir may cause other conditions to develop during HIV treatment.
Druge moguće nuspojave kombinirane terapije za HIV Kombinirana terapija koja sadrži Epivir može uzrokovati razvoj drugih bolesti i stanja tijekom liječenja HIV-a.
Epivir is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children.
Epivir je indiciran u kombinaciji s drugim antiretrovirusnim lijekovima za liječenje odraslih osoba i djece zaraženih virusom humane imunodeficijencije (HIV).
Hepatic impairment: Data obtained in patients with moderate to severe hepatic impairment shows that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.
Bolesnici s oštećenjem jetre: Podaci u bolesnika s umjerenim do teškim oštećenjem jetre pokazuju da oštećenje jetre ne utječe značajno na farmakokinetiku lamivudina.
• if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection,
• ako ste ikad imali neku bolest jetre, uključujući hepatitis B ili C (ako imate infekciju hepatitisom B, nemojte prestati uzimati Epivir prije nego što Vam to savjetuje liječnik jer se hepatitis može vratiti)
The usual dose of Epivir is 225 mg a day.
Uobičajena doza lijeka Epivir je 225 mg na dan.
Microcrystalline cellulose (E460), Sodium starch glycollate Magnesium stearate
Jezgra tablete: celuloza, mikrokristalična (E460), natrijev škroboglikolat, magnezijev stearat
10 mg/kg or
10 mg/kg ili
Indeed, the available clinical data are very limited and preclude any reliable conclusion in the field.
Klinički značaj navedenog nalaza nije utvrđen; klinički podaci su oskudni i onemogućavaju pouzdane zaključke.
30 to<50
30 do <50
Sucrose 20 % w/v (3 g/15 ml) Methyl parahydroxybenzoate Propyl parahydroxybenzoate Citric acid Anhydrous Propylene glycol Sodium citrate
6.1 Popis pomoćnih tvari saharoza 20% w/v (3 g/15ml) metilparahidroksibenzoat propilparahidroksibenzoat citratna kiselina, bezvodna propilenglikol natrijev citrat umjetna aroma jagode umjetna aroma banane pročišćena voda
What you need to know before you take Epivir
Što morate znati prije nego počnete uzimati Epivir Nemojte uzimati Epivir:
Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations), Harmire Road, Barnard Castle, Co. Durham DL12 8DT, United Kingdom
Glaxo Operations UK Ltd (posluje kao GlaxoWellcome Operations) Harmire Road, Barnard Castle Co.
Epivir helps to control your condition.
Budite u redovnom kontaktu sa svojim liječnikom Epivir pomaže u kontroli Vašeg stanja.
Dosing according to weight bands is recommended for Epivir tablets.
Preporučuje se dozirati Epivir tablete prema tjelesnoj težini.
Children weighing at least 14 kg and less than 20 kg:
Djeca tjelesne težine najmanje 14 kg, ali manje od 20 kg:
What Epivir looks like and the contents of the pack Epivir 300 mg film-coated tablets are supplied in white polyethylene bottles or blister packs containing 30 tablets.
Epivir 300 mg filmom obložene tablete su dostupne u bijelim polietilenskim bočicama ili blister pakiranjima koje sadrže 30 tableta.
Lamivudine demonstrates low cytotoxicity to peripheral blood lymphocytes, to established lymphocyte and monocyte-macrophage cell lines, and to a variety of bone marrow progenitor cells in vitro.
Lamivudin pokazuje nisku citotoksičnost prema perifernim limfocitima, prema diferenciranim linijama limfocita i monocita - makrofaga i prema brojnim pretečama stanica koštane srži u in vitro uvjetima.
Renal impairment: In patients with moderate to severe renal impairment, the terminal plasma half-life of lamivudine is increased due to decreased clearance, therefore the dose should be adjusted (see section 4.2).
Oštećenje bubrežne funkcije: U bolesnika s umjerenim do teškim oštećenjem funkcije bubrega poluvrijeme izlučivanja lamivudina u plazmi produljeno je zbog smanjenog klirensa te je stoga potrebno prilagoditi dozu (vidjeti dio 4.2.).
Musculoskeletal and connective tissue disorders Common: Arthralgia, muscle disorders Rare: Rhabdomyolysis
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često: artralgija, mišićni poremećaji Rijetko: rabdomioliza
Dosing recommendations - Adults, adolescents and children (weighing at least 25 kg):
Preporuke za doziranje u odraslih, adolescenata i djece (težine najmanje 25 kg):
Hypromellose (E464) Titanium dioxide (E171), Macrogol,
Film ovojnica tablete: hipromeloza (E464), titanijev dioksid (E171), makrogol, polisorbat 80
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Nuspojave su u svakoj skupini navedene od ozbiljnih prema manje ozbiljnima.
Child resistant HDPE bottles or PVC/aluminium foil blister packs each containing 60 tablets.
HDPE bočice sa sigurnosnim zatvaračem za djecu ili blister pakiranja od PVC/aluminijske folije koja sadrže 60 tableta.
What Epivir looks like and the contents of the pack Epivir 150 mg film-coated tablets are supplied in white polyethylene bottles or blister packs containing 60 tablets.
Epivir 150 mg filmom obložene tablete su dostupne u bijelim polietilenskim bočicama ili blister pakiranjima koje sadrže 60 tableta.
These may affect up to 1 in 1000 people:
Mogu se javiti kod do 1 na 1000 ljudi:
15 to <30
15 do <30
As well as the side effects listed below for Epivir, other conditions can develop during combination therapy for HIV.
Uz nuspojave lijeka Epivir spomenute u daljnjem tekstu mogu se razviti i druga stanja tijekom primjene kombinirane terapije za HIV.
10 mg/kg once daily or
10 mg/kg jedanput na dan ili
Lamivudine 8mg/kg OnceDaily Dosing Geometric Mean (95% Cl)
Lamivudin 8 mg/kg jedanput na dan - geometrijska srednja vrijednost (95% Cl)
This can be taken either as 15 ml (150 mg) twice a day (leaving approximately 12 hours between each dose), or as 30 ml (300 mg) once a day.
Može se uzeti kao 15 ml (150 mg) dvaput na dan (s razmakom od približno 12 sati između doza) ili kao 30 ml (300 mg) jedanput na dan.
In any case, initiation of susceptible NRTI's should always be preferred to maintenance of lamivudine therapy.
U svakom slučaju, preferira se započinjanje liječenja osjetljivim inhibitorima nukleozidne reverzne transkriptaze u odnosu na nastavak liječenja lamivudinom.
Twice Daily Plasma HIV-1 RNA <80 c/ml: n/N (%)
Dvaput na dan HIV-1 RNK u plazmi < 80 kopija/ml: n/N (%)
Child resistant HDPE bottles or PVC/aluminium foil blister packs each containing 30 tablets
HDPE bočice sa sigurnosnim zatvaračem za djecu ili blister pakiranja od PVC/aluminijske folije koja sadrže 30 tableta.
Tell your doctor if you are being treated with any of these.
Obavijestite svog liječnika ako uzimate neki od tih lijekova.
Film-coated tablets:
Filmom obložene tablete:
Administration of lamivudine in animal toxicity studies at high doses was not associated with any major organ toxicity.
U toksikološkim studijama na životinjama lamivudin primijenjen u visokim dozama nije uzrokovao oštećenja niti jednog organa.
Administration of lamivudine at very high dose levels in acute animal studies did not result in any organ toxicity.
U pokusima na životinjama primjena lamivudina u vrlo visokim dozama nije dovela do oštećenja organa.
300 mg (30 ml) once daily or
300 mg (30 ml) jedanput na dan ili
If you get side effects
Ako primijetite nuspojave
Adults, adolescents and children who weigh at least 25 kg:
Odrasli, adolescenti i djeca tjelesne težine najmanje 25 kg:
Epivir contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
Epivir sadrži metilparahidroksibenzoat i propilparahidroksibenzoat.
Each ml of oral solution contains 10 mg of lamivudine.
Jedan ml oralne otopine sadrži 10 mg lamivudina.
Consider more frequent monitoring of HIV-1 viral load when chronic coadministration cannot be avoided (see section 4.4).
Razmotrite češće praćenje opterećenja virusom HIV-1 kada se kronična istodobna primjena ne može izbjeći (vidjeti dio
Once Daily Plasma HIV-1 RNA <80 c/ml: n/N (%)
Jedanput na dan HIV-1 RNK u plazmi < 80 kopija/ml: n/N (%)
What Epivir looks like and the contents of the pack Epivir oral solution is supplied in a white polyethylene bottle containing 240 ml of solution.
Epivir oralna otopina je dostupna u bijeloj bočici od polietilena koja sadrži 240 ml otopine.
300 mg once daily or
300 mg jedanput na dan ili
Read the information ‘Other possible side effects of combination therapy for HIV' in
Pročitajte „Druge moguće nuspojave kombinirane terapije za bolesnike s HIV-om“ u dijelu 4
The triphosphate has selective inhibitory activity against HIV-1 and HIV-2 replication in vitro, it is also active against zidovudine-resistant clinical isolates of HIV.
Trifosfat je selektivni inhibitor replikacije HIV-1 i HIV-2 in vitro.
• high doses of co-trimoxazole, an antibiotic
• visoke doze antibiotika kotrimoksazola
Children weighing at least 20 kg and less than 25 kg:
Djeca tjelesne težine najmanje 20 kg, ali manje od 25 kg:
EU/1/96/015/003 (Bottle) EU/1/96/015/005 (Blister pack)
Epivir 300 mg filmom obložene tablete EU/1/96/015/003 (bočica) EU/1/96/015/005 (blister pakiranje)
BOTTLE CARTON FOR ORAL SOLUTION
KUTIJA ZA BOČICU S ORALNOM OTOPINOM
EU/1/96/015/001 (Bottle) EU/1/96/015/004 (Blister pack)
Epivir 150 mg filmom obložene tablete EU/1/96/015/001 (bočica) EU/1/96/015/004 (blister pakiranje)
• high doses of co-trimoxazole, an antibiotic.
• visoke doze antibiotika kotrimoksazola.
These may affect up to 1 in 10,000 people:
Mogu se javiti kod do 1 na 10 000 ljudi:
They are white, diamond shaped, scored, film-coated tablets, marked with the code ‘GXCJ7' on both sides.
Filmom obložene tablete su bijele, u obliku dijamanta, s razdjelnom crtom i s utisnutom oznakom „GXCJ7“ na obje strane.
Studies in patients with renal impairment show lamivudine elimination is affected by renal dysfunction.
Ispitivanja na bolesnicima s oštećenjem bubrega pokazuju da poremećaj u funkciji bubrega utječe na eliminaciju lamivudina.
If you have a kidney problem, your dose may be altered.
Ako imate problema s bubrezima, može biti potrebno promijeniti dozu.
The usual dose of Epivir is 150 mg a day.
Uobičajena doza lijeka Epivir je 150 mg na dan.
100 mg (10 ml) once daily
100 mg (10 ml) jedanput na dan
Respiratory, Thoracic and mediastinal disorders Common: Cough, nasal symptoms
Poremećaji dišnog sustava, prsišta i sredoprsja Često: kašalj, nazalni simptomi.
Hypromellose (E464), Titanium dioxide (E171), Black iron oxide (E172),
Film ovojnica tablete: hipromeloza (E464), titanijev dioksid (E171), željezov oksid, crni (E172), makrogol, polisorbat 80
Alternatively, for patients who are unable to swallow tablets, the tablet(s) 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).
Druga mogućnost za bolesnike koji ne mogu progutati tablete jest da ih zdrobe i pomiješaju s manjom količinom kašaste hrane ili tekućine te odmah progutaju (vidjeti dio 5.2).
However, unless the patient has renal impairment, no dosage adjustment of lamivudine is necessary (see section 4.2).
Međutim prilagodba doze nije potrebna osim ako bolesnik nema i oštećenu funkciju bubrega (vidjeti dio 4.2).
Paediatric population:a randomised comparison of a regimen including once daily vs twice daily dosing of abacavir and lamivudine was undertaken within a randomised, multicentre, controlled study of HIV-infected, paediatric patients.
Pedijatrijska populacija: U sklopu randomiziranog, multicentričnog, kontroliranog ispitivanja s pedijatrijskim bolesnicima zaraženima HIV-om provedena je randomizirana usporedba režima primjene abakavira i lamivudina jedanput na dan u odnosu na režim primjene dvaput na dan.
If you or your child has a kidney problem, the dose may be altered.
Ako imate ili ako Vaše dijete ima problema s bubrezima, može biti potrebno promijeniti dozu.
The observed half-life of elimination is 5 to 7 hours.
U ispitivanjima je dokazano da je pri intravenoznoj primjeni srednji volumen raspodjele 1,3 l/kg i da je poluvrijeme eliminacije 5 -7 sati.
The usual dose of Epivir is 300 mg a day.
Uobičajena doza lijeka Epivir je 300 mg na dan.
300 mg (30 ml)
300 mg (30 ml) ili
• if you or your child has a kidney problem, your dose may be altered.
• ako imate ili ako Vaše dijete ima problema s bubrezima, liječnik može promijeniti dozu lijeka.
150 mg (15 ml) twice daily
150 mg (15 ml) dvaput na dan
Do not store above 25°C
Ne čuvati na temperaturi iznad 25°C
Administration of co-trimoxazole with lamivudine in patients with renal impairment should be carefully assessed.
Treba pažljivo procijeniti potrebu istodobnog liječenja lamivudinom i kotrimoksazolom u bolesnika s oštećenom funkcijom bubrega.
This medicine has been prescribed for you or for your child. Do not pass it on to others.
- Ovaj je lijek propisan Vama ili Vašem djetetu.
They are grey, diamond shaped film-coated tablets, marked with the code ‘GXEJ7' on one side.
Filmom obložene tablete su sive, u obliku dijamanta s utisnutom oznakom „GXEJ7“ na jednoj strani.