natgillin/translations-raw huggingface dataset:
For subsequent cycles, the recommended total dose of BESPONSA is 1.5 mg/m2 per cycle given as 3 divided doses on Days 1 (0.5 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2) for patients who achieve a CR/CRi or 1.8 mg/m2 per cycle given as 3 divided doses on Days 1 (0.8 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2) for patients who do not achieve a CR/CRi. 
(0,5 mg/m 2) in 15. dan (0,5 mg/m 2), pri bolnikih, ki dosežejo CR/CRi, ali 1,8 mg/m 2 na cikel, ki ga dajemo v 3 deljenih odmerkih 1.
Increased alkaline phosphatase 
Preiskave zvečanje vrednosti alkalne fosfataze (13 %)
SN: 
IZ]
Potential hepatobiliary disease should be evaluated and treated according to standard medical practice. 
Bolnike je treba spremljati glede zvečanih vrednosti amilaze in lipaze, ocenjevati možnost za bolezni jeter, žolčnika in žolčevodov in jih zdraviti v skladu z običajno medicinsko prakso.
Median PFSe; months [95% CI] 
Mediano OS; meseci [95 % IZ]
Special populations Elderly 
Posebne skupine bolnikov
The active ingredient in BESPONSA is inotuzumab ozogamicin. 
Učinkovina v zdravilu BESPONSA je inotuzumab ozogamicin.
a CR, per EAC, was defined as < 5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts, full recovery of peripheral blood counts (platelets ≥ 100 × 109/L and ANC ≥ 1 × 109/L) and resolution of any extramedullary disease. 
CR je odbor EAC opredelil kot < 5 % blastov v kostnem mozgu in odsotnost levkemičnih blastov v periferni krvi, popolno izboljšanje periferne krvne slike (trombociti ≥ 100 × 10
c CR is defined as < 5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts, full recovery of peripheral blood counts (platelets ≥ 100 × 109/L and ANC ≥ 1 × 109/L) and resolution of any extramedullary disease. 
CR je opredeljen kot < 5 % blastov v kostnem mozgu in odsotnost levkemičnih blastov v periferni krvi, popolno izboljšanje periferne krvne slike (trombociti ≥ 100 × 10
Median OS; months [95% CI] 
; meseci [95 % IZ]
4 hours between reconstitution and dilution. 
Čas med rekonstitucijo in redčenjem mora biti ≤ 4 ure.
Median DoRg; months [95% CI] 
Mediano DoR g; meseci [95 % IZ]
The OS improvement for BESPONSA versus Investigator's choice of chemotherapy arm was seen in patients who underwent HSCT. 
Pri bolnikih, ki so jim opravili PKMC, so opazili izboljšanje OS za zdravilo BESPONSA v primerjavi s skupino s kemoterapijo po izbiri raziskovalca.
b CRi, per EAC, was defined as < 5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts, partial recovery of peripheral blood counts (platelets < 100 × 109/L and/or ANC < 1 × 109/L) and resolution of any extramedullary disease. 
CRi je odbor EAC opredelil kot < 5 % blastov v kostnem mozgu in odsotnost levkemičnih blastov v periferni krvi, delno izboljšanje periferne krvne slike (trombociti < 100 × 10
Dose (mg/m2) 
(0,8 mg/m
For the first cycle, the recommended total dose of BESPONSA for all patients is 1.8 mg/m2 per cycle, given as 3 divided doses on Days 1 (0.8 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2). 
Pri prvem ciklu je priporočeni celokupni odmerek zdravila BESPONSA za vse bolnike 1,8 mg/m 2 na cikel, ki ga dajemo v 3 deljenih odmerkih 1.
Women should use effective contraception during treatment with BESPONSA and for at least 
Ženske morajo med zdravljenjem z zdravilom BESPONSA in vsaj 8 mesecev po zadnjem odmerku uporabljati učinkovito metodo kontracepcije.
Careful consideration is required before administering BESPONSA to patients who have had a prior HSCT. 
Pri bolnikih s predhodnim PKMC je pred dajanjem zdravila BESPONSA potreben skrben razmislek.
These will require specific and sometimes preventive treatment. 
Te zahtevajo specifično in včasih preventivno zdravljenje.
Date of last renewal: 20 April 2011 
Datum zadnjega podaljšanja: 20. april 2011
Your doctor will therefore be monitoring the effectiveness of your treatment. 
Zdravnik bo zato spremljal učinkovitost vašega zdravljenja.
Do not change the dose on your own. 
Odmerka ne spreminjajte sami.
It also increases CD4 cell counts. 
Zvečuje tudi število celic CD4.
For this reason, it is important that you inform your doctor of any change in your health. 
Zato je pomembno, da svojega zdravnika obvestite o vsaki spremembi svojega zdravstvenega stanja.
The absolute bioavailability is 86±18%. 
Absolutna biološka uporabnost je 86 ± 18%.
a Number of patients evaluable. 
a Število ovrednotenih bolnikov.
Do not worry if the solution remains slightly hazy after mixing with water; this is normal. 
Naj vas ne skrbi, če ostane raztopina po mešanju z vodo rahlo motna; to je normalno.
Please follow these recommendations closely as they will give you the best chance to delay development of a resistance to the medicinal product. 
Natančno upoštevajte ta priporočila, ker boste tako imeli najboljšo možnost, da odložite razvoj odpornosti proti zdravilu.
Your doctor has defined your daily dose based on your weight and individual characteristics. 
Zdravnik je vaš dnevni odmerek določil glede na vašo telesno maso in individualne značilnosti.
Stavudine distributes equally between red blood cells and plasma. 
Stavudin se enakomerno razporedi med rdečimi krvnimi celicami in plazmo.
≤ 25 ml/min (including dialysis dependence*) 
≤ 25 ml/min (vključno z odvisnimi od dialize*)
These events have often been transitory. 
Ti neželeni učinki so bili pogosto prehodni.
Zerit with food and drink 
Zdravilo Zerit skupaj s hrano in pijačo
The mechanism and clinical significance of this difference are unknown. 
Mehanizem in klinični pomen te razlike nista znana.
The contribution of this to the total elimination in an overdose situation is unknown. 
Prispevek tega k celotni eliminaciji v primeru prevelikega odmerjanja ni znan.
Continue to take this medicine until your doctor tells you otherwise. 
Zdravilo jemljite, dokler vam zdravnik ne naroči drugače.
This rare, but very serious side effect occurs more often in women, particularly if very overweight. 
Ta redki, a zelo resni neželeni učinek je pogostejši pri ženskah, zlasti tistih, ki imajo čezmerno telesno maso.
Similar effects have been observed with other nucleoside analogues. 
Podobne učinke so opažali pri drugih nukleozidnih analogih.
These CD4 cells play an important role in maintaining a healthy immune system to help fight infection. 
Celice CD4 imajo pomembno vlogo pri vzdrževanju zdravega imunskega sistema, ki sodeluje pri premagovanju okužb.
Zerit should not be used during pregnancy unless clearly necessary. 
Zdravila Zerit se med nosečnostjo ne sme uporabljati, če to ni nujno potrebno.
Tell your doctor if you notice any loss of fat from your legs, arms, and face. 
Povejte svojemu zdravniku, če opazite kakršnokoli izgubo maščevja na nogah, rokah in obrazu.
Renal impairment: the following dosages are recommended 
Okvara ledvic: Priporočeni so naslednji odmerki
If needed, consult your pharmacist for help with this procedure. 
Če je potrebno, za pomoč pri tem postopku prosite farmacevta.
Instructions for preparation, see section 6.6. 
Za navodila za pripravo glejte poglavje 6.6.
It is not known whether stavudine is removed by peritoneal dialysis. 
Ni znano, ali se stavudin odstranjuje s peritonealno dializo.
The follow-up time was up to 24 weeks of age. 
Spremljali so jih do 24-tega tedna starosti.
Symptoms may continue or worsen following discontinuation of therapy. 
Simptomi se lahko nadaljujejo ali poslabšajo po prekinitvi zdravljenja.
If you have taken Zerit during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. 
Če ste zdravilo Zerit jemali med nosečnostjo, vas lahko vaš zdravnik naroča na redne preiskave krvi in druge diagnostične preiskave, da bo spremljal razvoj vašega otroka.
Stavudine may cause dizziness and/or somnolence. 
Stavudin lahko povzroči omotico in/ali zaspanost.
The frequency of adverse reactions listed below is defined using the following convention: 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). 
Pogostnost spodaj naštetih neželenih učinkov je opredeljena upoštevaje naslednji dogovor: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000).
The AUC(inf) for stavudine was 61% of the AUC(inf) of the total circulating radioactivity. 
Vrednost AUC(inf) za stavudin je znašala 61% vrednosti AUC(inf) skupne radioaktivnosti v obtoku.
Table 1: Efficacy Outcomes at Week 48 (Studies AI455-099 and AI455-096) 
Preglednica 1: Izidi učinkovitosti v 48. tednu (Študiji AI455-099 in AI455-096)
Experience in adults treated with up to 12 times the recommended daily dosage revealed no acute toxicity. 
Izkušnje pri odraslih, ki so dobivali do 12-kratne priporočene dnevne odmerke, niso odkrile akutnih toksičnih učinkov.
Because stavudine is not protein-bound, it is not expected to affect the pharmacokinetics of protein-bound medicines. 
Ker se stavudin ne veže na beljakovine, ni pričakovati, da bi spremenil farmakokinetiko zdravil, vezanih na beljakovine.
There have been no formal interaction studies with other medicinal products. 
Formalnih raziskav interakcij z drugimi zdravili ni bilo.
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.
Clinical experience in pregnant women is limited, but congenital anomalies and abortions have been reported. 
Klinične izkušnje pri nosečnicah so omejene, vendar pa so poročali o prirojenih hibah in splavih.
The safety and efficacy of stavudine has not been established in patients with significant underlying liver disorders. 
Varnost in učinkovitost stavudina nista ugotovljeni pri bolnikih s pomembno osnovno boleznijo jeter.
These capsules contain lactose. 
Kapsule vsebujejo laktozo.
However, clinically significant peripheral neuropathy is less frequent. 
Toda klinično pomembna periferna nevropatija je bila manj pogosta.
The number of reports in older infants was too small to identify a pattern. 
Pri starejših dojenčkih je bilo premalo poročil, da bi bilo mogoče ugotoviti vzorec.
Patient age and/or weight 
Bolnikova starost in/ali telesna masa
The use of stavudine in adolescents, children and infants is supported by pharmacokinetic and safety data in paediatric patients (see also sections 4.8 and 5.2). 
Uporabo stavudina pri mladostnikih, otrocih in dojenčkih podpirajo podatki o farmakokinetiki in varnosti pri pediatričnih bolnikih (glejte tudi poglavji 4.8 in 5.2).
Stable for 30 days after reconstitution, when stored in a refrigerator. 
Raztopina je stabilna 30 dni po pripravi, če se jo shranjujte v hladilniku.
Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machinery. 
Bolnikom je treba naročiti, da v primeru pojava tovrstnih simptomov ne smejo opravljati potencialno nevarnih opravil, kot sta vožnja vozil ali upravljanje strojev.
Dosing recommendations are not available for neonates with a gestational age < 37 weeks. 
Priporočil za odmerjanje pri novorojenčkih z gestacijsko starostjo < 37 tednov ni.
The possible benefits of a dose reduction should be balanced in each case against the risks - which may result from this measure (lower intracellular concentrations). 
Možne koristi zmanjšanja odmerka je v vsakem primeru treba primerjati s tveganji, ki so lahko posledica tovrstnega ukrepa (znižanje znotrajceličnih koncentracij).
Zidovudine is therefore not recommended to be used in combination with stavudine. 
Zato zidovudina ni priporočljivo uporabljati hkrati s stavudinom.
Special consideration should be given to the antiretroviral treatment history and the resistance profile of the HIV strain of the mother. 
Posebno pozornost je treba nameniti anamnezi o protiretrovirusnem zdravljenju in profilu odpornosti seva HIV pri materi.
What Zerit is and what it is used for 2. 
Kaj je zdravilo Zerit in za kaj ga uporabljamo 2.
Lactose intolerance: the hard capsule contains lactose. 
Intoleranca za laktozo: trda kapsula vsebuje laktozo.
If you accidentally miss a dose, then simply take your normal dose when the next one is due. 
Če pomotoma izpustite odmerek, preprosto vzemite normalen odmerek, ko je naslednjič čas za zdravilo.
What you need to know before you take Zerit 3. 
Kaj morate vedeti, preden boste vzeli zdravilo Zerit 3.
Patients with a history of neuropathy, or with other risk factors (for example alcohol, medicines such as isoniazid) are at particular risk. 
Bolniki z anamnezo periferne nevropatije ali z drugimi dejavniki tveganja (npr. alkohol, zdravila kot je izoniazid) so še posebej ogroženi.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika ali farmacevta, če jemljete,ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
However, you should contact your doctor or the nearest hospital for advice. 
Kljub temu se morate posvetovati s svojim zdravnikom ali najbližjo bolnišnico.
Hepatic impairment: no initial dosage adjustment is necessary. 
Okvara jeter: Začetnega odmerka ni treba prilagajati.
Studies in lactating rats showed that stavudine is excreted in breast milk. 
Raziskave pri doječih podganah so pokazale, da se stavudin izloča v materinem mleku.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products. 
V primeru sočasne protivirusne terapije proti hepatitisu B in C je treba upoštevati tudi relevantne informacije o teh zdravilih.
These are used to treat Human Immunodeficiency Virus (HIV) infection. 
Uporabljajo se za zdravljenje okužbe z virusom človeške imunske pomanjkljivosti (HIV).
The results of AI455-099 and AI455-096 are presented in Table 1. 
Rezultati študij AI455-099 in AI455-096 so prikazani v Preglednici 1.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered. 
Če se bolezen jeter pri takšnih bolnikih poslabša, je treba razmisliti o prekinitvi ali prenehanju zdravljenja.
Your doctor should monitor for signs of lipoatrophy. 
Zdravnik bo moral spremljati znake lipoatrofije.
Other medicines and Zerit 
Druga zdravila in zdravilo Zerit
In study AI455-094 (see also section 4.6), the safety follow-up period was restricted to only six months, which may be insufficient to capture long-term data on neurological adverse events and mitochondrial toxicity. 
V raziskavi AI455-094 (glejte tudi poglavje 4.6) so varnost spremljali le šest mesecev, kar je morda premalo, da bi zajeli dolgoročne podatke o nevroloških neželenih učinkih in toksičnosti za mitohondrije.
The data available on stavudine excretion into human breast milk are insufficient to assess the risk to the infant. 
Podatkov o izločanju stavudina v materinem mleku pri človeku ni dovolj, da bi omogočali oceno ogroženosti dojenčka.
It also inhibits viral DNA synthesis by causing DNA chain termination due to a lack of the 3'-hydroxyl group necessary for DNA elongation. 
Zavira tudi sintezo virusne DNA, ker povzroči zaključitev verige DNA zaradi pomanjkanja 3'-hidroksilne skupine, potrebne za podaljševanje DNA.
This medicinal product, in combination with other antiretrovirals, reduces the HIV viral load and keeps it at a low level. 
To zdravilo v kombinaciji z drugimi protiretrovirusnimi zdravili zmanjšuje virusno breme HIV in ga ohranja majhnega.
Infants under the age of 3 months: safety data are available from clinical trials up to 6 weeks of treatment in 179 newborns and infants < 3 months of age (see section 4.8). 
Dojenčki, mlajši od treh mesecev: 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).
Peripheral neuropathy: up to 20% of patients treated with Zerit will develop peripheral neuropathy, often starting after some months of treatment. 
Periferna nevropatija: Pri do 20% bolnikov, ki se zdravijo z zdravilom Zerit, se bo razvila periferna nevropatija, ki se bo najverjetneje pojavila po nekajmesečnem zdravljenju.
If you forget to take Zerit 
Če ste pozabili vzeti zdravilo Zerit
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).
The combination of stavudine with didanosine is contraindicated given that both drugs exhibits high risk of mitochondrial toxicity (see sections 4.3 and 4.4). 
Kombinacija stavudina z didanozinom je kontraindicirana, saj obe zdravili predstavljata veliko tveganje za mitohondrijsko toksičnost (glejte poglavji 4.3 in 4.4).
Elderly: Zerit has not been specifically investigated in patients over the age of 65. 
Starostniki: Zdravilo Zerit ni posebej raziskano pri bolnikih, starejših od 65 let.
The evolution of motor weakness may mimic the clinical presentation of Guillain-Barré syndrome (including respiratory failure). 
Razvoj motorične oslabelosti lahko posnema klinično sliko Guillain-Barréjevega sindroma (vključno z odpovedjo dihanja).
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.
For infants who require a dose less than 10 ml, ask your pharmacist for a syringe to use to accurately measure the oral dose. 
Za dojenčke, ki potrebujejo odmerke, manjše od 10 ml, prosite farmacevta za brizgo, s katero boste natančno odmerili peroralni odmerek.
Lactic acidosis generally occurred after a few or several months of treatment. 
Praviloma se laktacidoza pojavi po nekajmesečnem ali večmesečnem zdravljenju.
Adolescents, children and infants: total exposure to stavudine was comparable between adolescents, children and infants ≥ 14 days receiving the 2 mg/kg/day dose and adults receiving 1 mg/kg/day. 
Mladostniki, otroci in dojenčki: Celotna izpostavljenost stavudinu je bila primerljiva pri mladostnikih, otrocih in dojenčkih ≥ 14 dni, ki so dobivali odmerek 2 mg/kg/dan, in odraslimi, ki so dobivali 1 mg/kg/dan.
LIST OF EXCIPIENTS Sucrose and preservatives (E218 and E216) 
SEZNAM POMOŽNIH SNOVI Saharoza in konzervansa (E218 in E216).
The mother-infant pairs were randomised to receive either stavudine (N= 91), didanosine (N= 94), stavudine + didanosine (N= 88) or zidovudine (N= 89). 
Pare mater in dojenčkov so randomizirali tako, da so dobile bodisi stavudin (n = 91), didanozin (n = 94), stavudin in didanozin (n = 88) ali zidovudin (n = 89).
Binding of stavudine to serum proteins was negligible over the concentration range of 0.01 to 11.4 µg/ml. 
Vezava stavudina na beljakovine v serumu je bila v koncentracijskem območju od 0,01 do 11,4 µg/ml zanemarljiva.
After intravenous administration, 42% (range: 13% to 87%) of dose is excreted unchanged in the urine. 
Po intravenski aplikaciji se 42% (razpon: od 13% do 87%) odmerka izloči z urinom v nespremenjeni obliki.
Mean renal clearance of the parent compound is approximately 272 ml/min, accounting for approximately 67% of the apparent oral clearance, indicating active tubular secretion in addition to glomerular filtration. 
Srednji ledvični očistek izvorne učinkovine je približno 272 ml/min, kar je približno 67% navideznega peroralnega očistka, kar kaže na aktivno tubulno sekrecijo poleg glomerulne filtracije.
Only the data from the marketed formulation are presented. 
Prikazani so le podatki, ki se nanašajo na obliko, ki je dostopna na tržišču.
Most of these cases occurred in the setting of symptomatic hyperlactatemia or lactic acidosis syndrome (see section 4.4). 
Večina teh primerov se je pojavila v okviru simptomatske hiperlaktatemije ali sindroma laktacidoze (glejte poglavje 4.4).
An ex vivo study using a term human placenta model demonstrated that stavudine reaches the foetal circulation by simple diffusion. 
Raziskava ex vivo z uporabo modela človeške placente je pokazala, da pride stavudin v plodov obtok s preprosto difuzijo.
Patients treated with Zerit have reported the following side effects: 
Pri bolnikih, ki se zdravijo z zdravilom Zerit, so poročali o naslednjih neželenih učinkih:
Hence, hydroxyurea should not be used in the treatment of HIV infection. 
Hidroksisečnine zato ne smemo uporabljati pri zdravljenju okužb s HIV.
Response to treatment with Zerit varies between patients. 
Odziv na zdravljenje z zdravilom Zerit se od bolnika do bolnika razlikuje.
The pharmacokinetics of stavudine was independent of time, since the ratio between AUC(ss) at steady state and the AUC(0-t) after the first dose was approximately 1. 
Farmakokinetika stavudina ni odvisna od časa, ker je razmerje med AUC(ss) v stanju dinamičnega ravnovesja in AUC(0-t) po prvem odmerku približno 1.
The prepared oral solution is stable for 30 days in a refrigerator (2°C -8°C). 
Pripravljena peroralna raztopina je stabilna 30 dni, če se jo shranjuje v hladilniku (2 °C - 8 °C).
What Zerit is and what it is used for 
Kaj je zdravilo Zerit in za kaj ga uporabljamo
Zerit dosage (according to creatinine clearance) 
Odmerek zdravila Zerit (glede na očistek kreatinina)
Pharmacotherapeutic group: antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF04 
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, nukleozidni in nukleotidni zaviralci reverzne transkriptaze, oznaka ATC: J05AF04
Approximately 70% of the orally administered stavudine dose was excreted as an unchanged drug in urine. 
Približno 70% peroralno danega odmerka stavudina se je izločilo z urinom v nespremenjeni obliki.
Stavudine treatment can select for and/or maintain thymidine analogue mutations (TAMs) associated with zidovudine resistance. 
Zdravljenje s stavudinom lahko selekcionira in/ali ohrani mutacije timidinskih analogov (TAMthymidine analogue mutations), ki so povezane z odpornostjo proti zidovudinu.
Since urinary excretion is also a major route of elimination of stavudine in paediatric patients, the clearance of stavudine may be altered in paediatric patients with renal impairment. 
Izločanje stavudina v urinu je tudi ena glavnih poti eliminacije pri pediatričnih bolnikih, zato se lahko očistek stavudina pri pediatričnih bolnikih z okvaro ledvic spremeni.
This loss of body fat has been shown to be not fully reversible after discontinuation of stavudine. 
Kaže, da takšna izguba telesnega maščevja ni v celoti reverzibilna po prekinitvi zdravljenja s stavudinom.
Therefore, mothers should be instructed to discontinue breast-feeding prior to receiving Zerit. 
Zato je materam treba naročiti, naj nehajo dojiti, preden začnejo jemati zdravilo Zerit.
Animal data showed embryo-foetal toxicity at very high exposure levels. 
Pri živalih dobljeni podatki so pri zelo visoki ravni izpostavljenosti pokazali embrio-fetalne toksične učinke.
Interaction studies have only been performed in adults. 
Študije o medsebojnem delovanju z drugimi zdravili so bile izvedene le pri odraslih.
Data on lactic acid in serum were not collected. 
Podatkov o mlečni kislini v serumu niso zbirali.
When treating HIV infection, it is not always possible to differentiate between unwanted effects caused by Zerit, or those caused by any other medicines you may be taking at the same time, or by the complications of the infection. 
Pri zdravljenju okužbe s HIV ni vedno mogoče razlikovati med neželenimi učinki, ki jih povzroči zdravilo Zerit, ter med neželenimi učinki drugih zdravil, ki jih morda jemljete hkrati, in zapleti same okužbe.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08 May 1996 
Datum prve odobritve: 8. maj 1996