natgillin/translations-raw huggingface dataset:
The Committee decided that Zerit’ s benefits are greater than its risks in combination with other antiretroviral medicinal products for the treatment of HIV infected patients.
Odbor meni, da so koristi zdravila Zerit v kombinaciji z drugimi protiretrovirusnimi zdravili pri zdravljenju bolnikov, okuženih s HIV- 1, večje od z njim povezanih tveganj.
It recommended that Zerit be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Zerit.
Other information about Zerit:
Druge informacije o zdravilu Zerit:
The European Commission granted a marketing authorisation valid throughout the European Union for Zerit to BRISTOL-MYERS SQUIBB PHARMA EEIG on 8 May 1996.
Evropska komisija je dovoljenje za promet z zdravilom Zerit, veljavno po vsej Evropski uniji, odobrila družbi BRISTOL- MYERS SQUIBB PHARMA EEIG dne 8. maja 1996.
The marketing authorisation was renewed on 8 May 2001 and 8 May 2006.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 8. maja 2001 in 8. maja 2006.
The full EPAR for Zerit is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zerit je na voljo tukaj.
Invented name
pot uporabe
Route of administration Packaging
EU/ 1/ 96/ 009/ 001 EU/ 1/ 96/ 009/ 002
Content (concentration)
plastenka (HDPE) pretisni omot (aclar/ alu)
EU/ 1/ 96/ 009/ 001 EU/ 1/ 96/ 009/ 002 EU/ 1/ 96/ 009/ 003 EU/ 1/ 96/ 009/ 004 EU/ 1/ 96/ 009/ 005 EU/ 1/ 96/ 009/ 006 EU/ 1/ 96/ 009/ 007 EU/ 1/ 96/ 009/ 008
EU/ 1/ 96/ 009/ 005 EU/ 1/ 96/ 009/ 006
15 mg 15 mg 20 mg 20 mg 30 mg 30 mg 40 mg 40 mg
30 mg 30 mg
Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
kapsula, trda kapsula, trda
Oral use Bottle (HDPE) Oral use Blister (aclar/ alu) Oral use Bottle (HDPE) Oral use Blister (aclar/ alu) Oral use Bottle (HDPE) Oral use Blister (aclar/ alu) Oral use Bottle (HDPE) Oral use Blister (aclar/ alu)
plastenka (HDPE) pretisni omot (aclar/ alu)
60 capsules 56 capsules 60 capsules 56 capsules 60 capsules 56 capsules 60 capsules 56 capsules
60 kapsul 56 kapsul
200 mg (1 mg/ ml) 1 Bottle after reconstitution
200 mg (1 mg/ ml) 1 plastenka po rekonstituciji
Zerit 15 mg hard capsule
Zerit 15 mg trde kapsule
Each hard capsule contains 15 mg of stavudine.
Vsaka trda kapsula vsebuje 15 mg stavudina.
The hard capsule is red and yellow, opaque and imprinted with “ BMS” over a BMS code “ 1964” on one side and “ 15” on the other side.
Trda kapsula je rdeča in rumena, neprozorna, z oznako "BMS" nad BMS kodo “ 1964 ” na eni strani in “ 15 ” na drugi strani.
Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV infected patients.
Zdravilo Zerit je indicirano za zdravljenje bolnikov, okuženih s HIV, v kombinaciji z drugimi protiretrovirusnimi zdravili.
The therapy should be initiated by a doctor experienced in the management of HIV infection (see also section 4.4).
Zdravljenje mora začeti zdravnik, ki ima izkušnje z zdravljenjem okužbe s HIV (glejte tudi poglavje 4. 4).
Adults: the recommended dosage is:
Priporočeno odmerjanje je:
Patient weight < 60 kg ≥ 60 kg
< 60 kg ≥ 60 kg
Zerit dosage 30 mg twice daily (every 12 hours) 40 mg twice daily
30 mg dvakrat na dan (na 12 ur) 40 mg dvakrat na dan
Adolescents, children and infants over the age of 3 months: the recommended dosage is:
Priporočeno odmerjanje je:
Patient weight < 30 kg ≥ 30 kg
< 30 kg ≥ 30 kg
Zerit dosage 1 mg/ kg twice daily (every 12 hours) adult dosing
1 mg/ kg dvakrat na dan (na 12 ur) odmerjanje je enako kot za odrasle
For optimal absorption, Zerit should be taken on an empty stomach (i. e. at least 1 hour prior to meals) but, if this is not possible, it may be taken with a light meal.
Za optimalno absorpcijo je treba zdravilo Zerit vzeti na prazen želodec (tj. vsaj 1 uro pred obroki); če to ni mogoče, ga je mogoče vzeti tudi z lahkim obrokom.
Zerit may also be administered by carefully opening the hard capsule and mixing the contents with food.
Zdravilo Zerit je mogoče uporabiti tudi tako, da se trdo kapsulo previdno odpre in njeno vsebino zmeša s hrano.
Infants under the age of 3 months: please refer to the Summary of Product Characteristics of the powder formulation.
Glejte povzetek glavnih značilnosti zdravila za prašek.
Zerit has not been specifically investigated in patients over the age of 65.
Zdravila Zerit niso posebej preučevali pri bolnikih, starejših od 65 let.
Peripheral neuropathy: if symptoms of peripheral neuropathy develop (usually characterised by persistent numbness, tingling, or pain in the feet and/ or hands) (see section 4.4) patients should be switched to an alternative treatment regimen, if appropriate.
Če se pojavijo simptomi periferne nevropatije (njena značilnost so ponavadi dolgotrajna omrtvelost, mravljinčenje ali bolečine v stopalih in/ ali dlaneh) (glejte poglavje 4. 4), je treba zdravljenje zamenjati z alternativnim, če je to primerno.
In the rare cases when this is
V redkih primerih, v katerih to ni
2 inappropriate, dose reduction of stavudine may be considered, while the symptoms of peripheral neuropathy are under close monitoring and satisfactory virological suppression is maintained.
2 primerno, se lahko razmisli o zmanjšanju odmerka stavudina, pri čemer je treba zagotoviti skrben nadzor nad simptomi periferne nevropatije in zagotoviti zadovoljivo zaviranje razmnoževanja virusa.
Hepatic impairment: no initial dosage adjustment is necessary.
Začetnega odmerka ni treba prilagajati.
Renal impairment: the following dosages are recommended:
Priporočeni so naslednji odmerki:
≤ 25 ml/ min (including dialysis dependence*)
≤ 25 ml/ min (vključno z odvisnimi od dialize *)
15 mg twice daily 20 mg twice daily
15 mg dvakrat na dan 20 mg dvakrat na dan
15 mg every 24 hours 20 mg every 24 hours
15 mg na 24 ur 20 mg na 24 ur
* Patients on haemodialysis should take Zerit after the completion of haemodialysis, and at the same time on non-dialysis days.
* Bolniki na hemodializi naj zdravilo Zerit vzamejo po koncu hemodialize, v dneh ko nimajo dialize, pa ob istem času.
Although there are insufficient data to recommend a specific dosage adjustment of Zerit in this patient population, a reduction in the dose and/ or an increase in the interval between doses proportional to the reduction for adults should be considered.
Priporočil za specifično prilagoditev odmerkov zdravila Zerit pri tej populaciji bolnikov zaradi pomanjkanja podatkov sicer ni mogoče dati, vendar je treba razmisliti o zmanjšanju odmerka in/ ali podaljšanju intervala med odmerki, sorazmerno zmanjšanju pri odraslih.
Hypersensitivity to stavudine or to any of the excipients.
Preobčutljivost za stavudin ali katero koli pomožno snov.
Peripheral neuropathy: patients with a history of peripheral neuropathy are at increased risk for development of neuropathy.
Bolnike z anamnezo periferne nevropatije bolj ogroža pojav nevropatije.
If Zerit must be administered in this setting, careful clinical monitoring is essential.
Če je v takšnih primerih treba uporabiti zdravilo Zerit, je nujno skrbno klinično nadziranje.
Symptoms of peripheral neuropathy are characterised by persistent numbness, tingling, or pain in the feet and/ or hands.
Značilni simptomi periferne nevropatije so dolgotrajna omrtvelost, mravljinčenje ali bolečine v stopalih in/ ali dlaneh.
Pancreatitis: patients with a history of pancreatitis had an incidence of approximately 5% on Zerit, as compared to approximately 2% in patients without such a history.
Pri bolnikih z anamnezo pankreatitisa je incidenca med uporabo zdravila Zerit približno 5%, pri bolnikih brez takšne anamneze pa približno 2%.
Patients with a high risk of pancreatitis or those receiving products known to be associated with pancreatitis should be closely followed for symptoms of this condition.
Skrbno je treba nadzorovati bolnike, ki jih pankreatitis posebno ogroža in tiste, ki jemljejo zdravila, ki lahko povzročajo pankreatitis.
Lactic acidosis: lactic acidosis, usually associated with hepatomegaly and hepatic steatosis has been reported with the use of nucleoside reverse transcriptase inhibitors (NRTIs).
Med uporabo zaviralcev nukleozidne in nukleotidne reverzne transkriptaze je bila opisana laktacidoza, ponavadi skupaj s hepatomegalijo in steatozo jeter.
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).
Zgodnji simptomi (simptomatska hiperlaktatemija) vključujejo blage prebavne težave (navzeo, bruhanje in bolečine v trebuhu), nespecifično splošno slabo počutje, izgubo teka, hujšanje, respiratorne simptome (hitro in/ ali globoko dihanje) ali nevrološke simptome (vključno z motorično šibkostjo).
Lactic acidosis generally occurred after a few or several months of treatment.
Praviloma se laktacidoza pojavi po nekajtedenskem ali večtedenskem zdravljenju.
Treatment with NRTIs should be discontinued if there is symptomatic hyperlactatemia and metabolic/ lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Če se pojavijo simptomatska hiperlaktatemija in metabolična acidoza/ laktacidoza, napredujoča hepatomegalija ali hitro zviševanje aminotransferaz, je treba zdravljenje z nukleozidnimi in nukleotidnimi zaviralci reverzne transkriptaze prekiniti.
Caution should be exercised when administering NRTIs 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).
Previdnost je potrebna med uporabo zaviralcev nukleozidne in nukleotidne reverzne transkriptaze pri bolnikih (predvsem pri ženskah s prekomerno telesno težo) s hepatomegalijo, hepatitisom ali drugimi znanimi dejavniki tveganja za bolezni jeter ali steatozo jeter (vključno z določenimi zdravili in alkoholom).
Patients at increased risk should be followed closely (see also section 4.6).
Bolj ogrožene bolnike je treba natančno spremljati (glejte tudi poglavje 4. 6).
3 disorders.
3 Bolezni jeter:
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse events.
Bolnike s kroničnim hepatitisom B ali C, ki dobivajo kombinirano protiretrovirusno zdravljenje, bolj ogrožajo hudi in potencialno usodni neželeni učinki na jetrih.
In the event of rapidly elevating transaminase levels (ALT/ AST, > 5 times upper limit of normal, ULN), discontinuation of Zerit and any potentially hepatotoxic medicinal products should be considered.
Če raven transaminaz hitro poraste (ALT/ AST > 5- kratna zgornja normalna meja, (ZNM)), je treba razmisliti o prenehanju uporabe zdravila Zerit in morebitnih drugih hepatotoksičnih zdravil.
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.
Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - "combination antiretroviral therapy") nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične patogene in povzroči resna klinična stanja ali poslabšanje simptomov.
Lipodystrophy and metabolic abnormalities: combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
Kombinirana protiretrovirusna terapija je bila pri bolnikih, okuženih s HIV, povezana s prerazporeditvijo telesnega maščevja (lipodistrofijo).
A connection between visceral lipomatosis and Protease Inhibitors and lipoatrophy and NRTIs has been hypothesised.
Domnevajo, da obstaja povezava med visceralno lipomatozo in zaviralci proteaz ter lipoatrofijo in nukleozidni in nukleotidni zaviralci reverzne transkriptaze.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Motnje lipidov je treba obravnavati kot je klinično ustrezno (glejte poglavje 4. 8).
There is evidence that mitochondrial DNA toxicity may be associated with specific features of lipoatrophy in patients using stavudine.
Obstajajo dokazi, da je pri bolnikih, ki uporabljajo stavudin toksičnost za mitohondrijsko DNA lahko povezana s specifičnimi značilnostmi lipoatrofije.
This should be taken into account when considering initiation of combination antiretroviral therapy with stavudine.
Slednje je treba upoštevati pri načrtovanju začetka kombiniranega protiretrovirusnega zdravljenja s stavudinom.
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).
Osteonekroza: čeprav je vzrokov verjetno več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo imunosupresijo, višjim indeksom telesne mase), so o primerih osteonekroze poročali zlasti pri bolnikih z napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART – combination antiretroviral therapy) ali obojim.
Zerit has not been specifically investigated in patients over the age of 65.
Zdravilo Zerit ni posebej raziskano pri bolnikih, starejših od 65 let.
Infants under the age of 3 months: safety data is available from clinical trials up to 6 weeks of treatment in 179 newborns and infants < 3 months of age (see section 4.8).
Na voljo so podatki o varnosti iz kliničnih preskušanj, ki so zajele do 6- tedensko zdravljenje pri 179 novorojenčkih in dojenčkih, mlajših od 3 mesecev (glejte poglavje 4. 8).
There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/ or post-natally to nucleoside analogues (see also section 4.8).
Obstajajo poročila o mitohondrijski disfunkciji pri HIV- negativnih dojenčkih, ki so bili in utero in/ ali postnatalno izpostavljeni nukleozidnim analogom (glejte tudi poglavje 4. 8).
These events are often transitory.
Ti neželeni učinki so pogosto
4 have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in case of relevant signs or symptoms.
4 prehodni.
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Trenutno ni znano, ali so te nevrološke motnje prehodne ali trajne.
Not recommended combinations: pancreatitis (fatal and nonfatal) and peripheral neuropathy (severe in some cases) have been reported in HIV infected patients receiving stavudine in association with hydroxyurea and didanosine.
Pri bolnikih, okuženih s HIV, ki so dobivali stavudin skupaj s hidroksisečnino in didanozinom so bili opisani usodni in neusodni pankreatitis in periferna nevropatija (ki je bila v nekaterih primerih huda).
Hepatotoxicity and hepatic failure resulting in death were reported during postmarketing surveillance in HIV infected patients treated with antiretroviral agents and hydroxyurea; fatal hepatic events were reported most often in patients treated with stavudine, hydroxyurea and didanosine.
V obdobju spremljanja zdravila na tržišču so bili pri bolnikih, okuženih s HIV, ki so dobivali protiretrovirusna zdravila in hidroksisečnino, opisani hepatotoksični učinki in odpoved jeter s smrtnim izidom; usodni jetrni dogodki so bili najpogosteje opisani pri bolnikih, zdravljenih s stavudinom, hidroksisečnino in didanozinom.
Lactose intolerance: the hard capsule contains lactose (120 mg).
Trda kapsula vsebuje laktozo (120 mg).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšanja aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze ne smejo jemati tega zdravila.
Interaction studies have only been performed in adults
Študije o medsebojnem delovanju z drugimi zdravili so bile izvedene le pri odraslih.
Since stavudine is actively secreted by the renal tubules, interactions with other actively secreted medicinal products are possible, e. g. with trimethoprim.
Stavudin se aktivno izloča v ledvičnih tubulih, zato so možne interakcije z drugimi zdravili, ki se tudi aktivno izločajo, npr. s trimetoprimom.
Zidovudine and stavudine are phosphorylated by the cellular enzyme (thymidine kinase), which preferentially phosphorylates zidovudine, thereby decreasing the phosphorylation of stavudine to its active triphosphate form.
Fosforilacija zidovudina in stavudina poteka s celičnim encimom (timidin- kinazo), ki prednostno fosforilira zidovudin, tako da se zmanjša fosforilacija stavudina v njegovo aktivno trifosfatno obliko.
In vitro studies indicate that the activation of stavudine is inhibited by doxorubicin and ribavirin but not by other medicinal products used in HIV infection which are similarly phosphorylated, (e. g. didanosine, zalcitabine, ganciclovir and foscarnet) therefore, coadministration of stavudine with either doxorubicin or ribavirin should be undertaken with caution.
Študije in vitro kažejo, da aktiviranje stavudina zavirata doksorubicin in ribavirin, ne pa druga zdravila, ki se uporabljajo proti okužbi s HIV in se podobno fosforilirajo (npr. didanozin, zalcitabin, ganciklovir in foskarnet), zato je pri sočasnem dajanju stavudina in bodisi doksorubicina ali ribavirina potrebna previdnost.
Stavudine’ s influence on the phosphorylation kinetics of nucleoside analogues other than zidovudine has not been investigated.
Vpliv stavudina na fosforilacijsko kinetiko drugih nukleozidnih analogov razen zidovudina ni raziskan.
Stavudine does not inhibit the major cytochrome P450 isoforms CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4; therefore, it is unlikely that clinically significant drug interactions will occur with drugs metabolised through these pathways.
Stavudin ne zavira glavnih izooblik citokroma P450, CYP1A2, CYP2C9, CYP2C19, CYP2D6 in CYP3A4, zato ni verjetno, da bi se pojavile klinično pomembne interakcije z zdravili, ki se presnavljajo po teh poteh.
Because stavudine is not protein-bound, it is not expected to affect the pharmacokinetics of protein-bound drugs.
Ker se stavudin ne veže na beljakovine, ni pričakovati, da bi spremenil farmakokinetiko zdravil, vezanih na beljakovine.
In study AI455-094, performed in South-Africa, 362 mother-infant pairs were included in a prevention of mother-to-child-transmission study.
V raziskavi AI455- 094, opravljeni v Južni Afriki, so pri 362 parih mater in dojenčkov proučevali preprečevanje prenosa z matere na otroka.
Antiretroviral prophylaxis,
V raziskavo so vključili nosečnice v obdobju od 34. do 36. gestacijskega tedna, ki še niso bile zdravljene s protiretrovirusnimi zdravili in so do poroda dobivale
5 the same medications as given to the mother, was given to the new-born infant within 36 hours of delivery and continued for 6 weeks.
Novorojenčki so dobivali protiretrovirusno profilakso z istim zdravilom, kot ga je jemala mati; prvič so ga dobili v 36 urah po rojstvu in so ga prejemali 6 tednov.
In the stavudine containing arms, the neonates were treated for 6 weeks with stavudine 1 mg/ kg BID.
V kraku s stavudinom so novorojenčke 6 tednov zdravili z 1 mg stavudina/ kg dvakrat na dan.
The follow-up time was up to 24 weeks of age.
Spremljali so jih do 24- tega tedna starosti.
95% Confidence intervals for the mother-to-child-transmission rates were 5.4-19.3% (stavudine), 5.2-18.7% (didanosine); 1.3-11.2% (stavudine + didanosine); and 1.9-12.6% for zidovudine.
95% intervali zaupanja za prenos z matere na otroka so bili 5, 4– 19, 3% (stavudin), 5, 2– 18, 7% (didanozin), 1, 3– 11, 2% (stavudin in didanozin) in 1, 9– 12, 6% za zidovudin.
Preliminary safety data from this study (see also section 4.8), showed an increased infant mortality in the stavudine + didanosine (10%) treatment group compared to the stavudine (2%), didanosine (3%) or zidovudine (6%) groups, with a higher incidence of stillbirths in the stavudine + didanosine group.
Kažejo tudi večjo incidenco mrtvorojenosti v skupini s stavudinom in didanozinom.
However, lactic acidosis (see section 4.4), sometimes fatal, has been reported in pregnant women who received the combination of didanosine and stavudine with or without other anti-retroviral treatment.
Vendar je bila pri nosečnicah, ki so dobivale kombinacijo didanozina in stavudina – z drugimi protiretrovirusnimi zdravili ali brez njih – opisana laktacidoza (glejte poglavje 4. 4), ki je bila včasih usodna.
Embryo-foetal toxicities were seen only at high exposure levels in animals.
Embrio- fetalne toksične učinke so pri živalih ugotavljali le pri visoki ravni izpostavljenosti.
Preclinical studies showed placental transfer of stavudine (see section 5.3).
Predklinične raziskave kažejo, da stavudin prehaja skozi placento (glejte poglavje 5. 3).
Furthermore, the combination of stavudine and didanosine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk.
Poleg tega je treba kombinacijo stavudina in didanozina med nosečnostjo uporabljati previdno; priporočljiva je le, če možne koristi jasno pretehtajo v primerjavi z možnimi tveganji.
No studies on the effects on the ability to drive and use machines have been performed.
Študije o vplivih na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
Based on the pharmacodynamic properties of stavudine it is unlikely that Zerit affects the ability to drive or operate machinery.
Glede na farmakodinamične lastnosti stavudina ni verjetno, da bi zdravilo Zerit poslabšalo sposobnost vožnje ali upravljanja s stroji.
Adults: extensive safety experience is available for Zerit used as monotherapy and in combination regimens.
Na voljo so obširne izkušnje o varnosti zdravila Zerit, uporabljenega v monoterapiji in kombiniranih shemah.
Many of the serious undesirable effects with stavudine were consistent with the course of HIV infection or with the side effects of concomitant therapies.
Številni resni neželeni učinki med uporabo stavudina so se skladali s potekom okužbe s HIV ali z neželenimi učinki sočasno uporabljenih terapij.
In combination studies of Zerit with lamivudine plus efavirenz, the frequency of peripheral neurologic symptoms was 19% (6% for moderate to severe) with a rate of discontinuation due to neuropathy of 2%.
V študijah, v katerih so zdravilo Zerit uporabljali v kombinaciji z lamivudinom in efavirenzem, je bila pogostnost perifernih nevroloških simptomov 19% (6% zmernih do hudih); delež prekinitev zaradi nevropatije je bil 2%.
Dose-related peripheral neuropathy occurred in monotherapy trials with Zerit (see sections 4.2 and 4.4).
Vpreskušanjih, v katerih so zdravilo Zerit uporabljali v monoterapiji, se je pojavila od odmerka odvisna periferna nevropatija (glejte poglavji 4. 2 in 4. 4).
The patients usually experienced resolution of symptoms after dose reduction or interruption.
Po zmanjšanju odmerka ali prekinitvi uporabe so simptomi ponavadi izzveneli.
Pancreatitis: pancreatitis, occasionally fatal, has been reported in up to 2-3% of patients enrolled in monotherapy clinical studies (see section 4.4).
Pankreatitis, ki je bil občasno usoden, so opisali pri 2 do 3% bolnikov, vključenih v klinične študije z monoterapijo (glejte poglavje 4. 4).
Lactic acidosis: cases of lactic acidosis, sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of nucleoside analogues (see section 4.4).
Med uporabo nukleozidnih analogov so poročali o primerih laktacidoze, ki je bila včasih usodna in je bila ponavadi povezana s hudo hepatomegalijo in steatozo jeter (glejte poglavje 4. 4).