natgillin/translations-raw huggingface dataset:
Abbreviations: ALL=acute lymphoblastic leukaemia; ANC=absolute neutrophil counts; Ara-C=cytarabine; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete haematological recovery; DoR=duration of remission; EAC=Endpoint Adjudication Committee; FLAG=fludarabine + cytarabine + granulocyte colony-stimulating factor; HIDAC=high dose cytarabine; HSCT=haematopoietic stem cell transplant; ITT=intent-to-treat; MRD=minimal residual disease; MXN=mitoxantrone; N/n=number of patients; OS=overall survival; PFS=progression-free survival. 
CI=interval pouzdanosti; CR=potpuna remisija; CRi=potpuna remisija s nepotpunim oporavkom krvne slike; DoR=trajanje remisije; EAC=Odbor za odlučivanje o mjerama ishoda; FLAG=fludarabin + citarabin
Headache (28%) 
Infekcija (48%)
28 dayse 
28 dana
In patients receiving inotuzumab ozogamicin, infusion related reactions were reported (see section 4.8). 
Reakcije povezane s infuzijom su prijavljene u bolesnika koji primaju inotuzumab ozogamicin (vidjeti dio 4.8).
Inotuzumab is a humanised immunoglobulin class G subtype 4 (IgG4) antibody that specifically recognises human CD22. 
Inotuzumab je humanizirani imunoglobulin razreda G podtipa 4
The OS improvement for BESPONSA versus Investigator's choice of chemotherapy arm was seen in patients who underwent HSCT. 
U bolesnika koji su podvrgnuti HSCT-u zabilježeno je poboljšanje ukupnog preživljenja u skupini s lijekom BESPONSA u odnosu na one koji su primali kemoterapiju po izboru ispitivača.
- Use immediately or store at room temperature (20 °C-25 °C) or in a refrigerator (2 °C-8 °C). 
- Iskoristiti odmah ili čuvati na sobnoj temperaturi (20°C - 25°C) ili u hladnjaku (2°C - 8°C).
Eligible patients were ≥ 18 years of age with Philadelphia chromosome negative (Ph-) or Ph+ relapsed or refractory B-cell CD22-positive precursor ALL. 
Bolesnici podobni za uključivanje u ispitivanje su imali ≥ 18 godina i CD22-pozitivnu akutnu limfoblastičnu leukemiju prekursora B limfocita s Philadephia negativnim (Ph
4 hours between reconstitution and dilution. 
Između rekonstitucije i razrjeđivanja smije proći ≤ 4 sata.
Increased alkaline phosphatase 
Povećane razine alkalne fosfataze (13%)
• Fatigue 
• Mučnina
For the first cycle, the recommended total dose for all patients is 1.8 mg/m2 per cycle, administered as 3 divided doses on Days 1 (0.8 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2). 
Za prvi ciklus, preporučena ukupna doza u svih bolesnika je 1,8 mg/m 2 po ciklusu te se daje podijeljena u 3 doze: 1. dana (0,8 mg/m 2), 8. dana (0,5 mg/m 2) i 15. dana (0,5 mg/m 2).
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). 
Za prvi ciklus, preporučena ukupna doza lijeka BESPONSA u svih bolesnika je 1,8 mg/m 2 po ciklusu te se daje podijeljena u 3 doze: 1. dana (0,8 mg/m 2), 8. dana (0,5 mg/m 2) i 15. dana (0,5 mg/m 2).
For subsequent cycles, the recommended total dose is 1.5 mg/m2 per cycle administered 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. 
Za sljedeće cikluse, preporučena ukupna doza lijeka BESPONSA je 1,5 mg/m 2 po ciklusu te se daje podijeljena u 3 doze: 1. dana (0,5 mg/m 2), 8. dana (0,5 mg/m 2) i 15. dana (0,5 mg/m 2) u bolesnika u kojih je postignut CR/CRi, odnosno 1,8 mg/m 2 po ciklusu podijeljeno u 3 doze: 1. dana (0,8 mg/m
The maximum time from reconstitution through the end of administration should be ≤ 8 hours, with ≤ 
Maksimalno vrijeme od rekonstitucije do kraja primjene treba biti ≤ 8 sati, s tim da između rekonstitucije i razrjeđivanja smiju proći ≤ 4 sata.
Haemorrhagec (33%) (includes Central nervous system haemorrhage [1%], Upper gastrointestinal haemorrhage [6%], Lower gastrointestinal haemorrhage [4%], Epistaxis 
Hemoragija c (33%) (uključujući krvarenje u središnjem živčanom sustavu [1%], krvarenje iz gornjeg dijela gastrointestinalnog sustava [6%], krvarenje iz donjeg dijela gastrointestinalnog sustava [4%], epistaksa [15%] Poremećaji probavnog sustava Bol u abdomenu (23%) Povraćanje (15%) Proljev (17%) Mučnina (31%) Stomatitis (13%) Zatvor (17%)
s r.o. 
9/l.
• Inspect the reconstituted solution for particulates and discolouration. 
• Pregledajte rekonstituiranu otopinu kako bi se utvrdilo da ne sadrži čestice i nije promijenila boju.
• Chills 
• Proljev
In patients receiving inotuzumab ozogamicin, increases in amylase and lipase have been reported (see section 4.8). 
Povišene razine amilaze i lipaze prijavljene su u bolesnika koji primaju inotuzumab ozogamicin (vidjeti dio 4.8).
In patients receiving inotuzumab ozogamicin, prolonged QT interval was observed (see section 4.4). 
Produljenje QT-intervala je primijećeno u bolesnika koji primaju inotuzumab ozogamicin (vidjeti dio 4.4).
Median PFSe; months [95% CI] 
Medijan OS-a; mjeseci [95% CI]
After reconstitution each vial contains 0.25 mg/mL of inotuzumab ozogamicin. 
Nakon rekonstitucije jedna bočica sadrži 0,25 mg/ml inotuzumab ozogamicina.
and/or vincristine to a peripheral blast count ≤ 10,000/mm3 is recommended prior to the first dose. 
Citoredukcija s primjenom kombinacije hidroksiureje, steroida i/ili vinkristina do broja perifernih blasta od ≤ 10 000/mm
There are no data in pregnant women using inotuzumab ozogamicin. 
Nema podataka o primjeni inotuzumab ozogamicina u trudnica.
• The diluted solution must be used immediately, stored at room temperature (20 °C-25 °C) or in a refrigerator (2 °C-8 °C). 
• Razrijeđena otopina se mora odmah iskoristiti, čuvati na sobnoj temperaturi (20°C - 25°C) ili u hladnjaku (2°C - 8°C).
Median PFSe, f; months [95% CI] 
Medijan DoR-a g; mjeseci [95% CI]
Patients with mixed-lineage leukaemia (MLL) gene rearrangements, including t (4;11), that generally have lower 
Bolesnici s restrukturiranjem gena kod mješovite leukemije (engl. mixed-lineage leukaemia, MLL), uključujući t(4;11), koji uglavnom imaju manju ekspresiju CD22 prije liječenja, imali su lošije rezultate OS-a nakon liječenja s lijekom BESPONSA ili kemoterapijom po izboru ispitivača.
• Bleeding 
• Krvarenje
Use diluted solution immediately or after being stored at room temperature (20 °C-25 °C) or in a refrigerator (2 °C-8 °C). 
Iskoristite razrijeđenu otopinu odmah ili nakon što je bila čuvana na sobnoj temperaturi (20°C25°C) ili u hladnjaku (2°C8°C).
You must avoid becoming pregnant or fathering a child. Women must use effective contraception during treatment and for at least 8 months after the last dose of treatment. 
Žene trebaju koristiti učinkovitu kontracepciju tijekom liječenja lijekom BESPONSA i najmanje 8 mjeseci nakon zadnje doze.
The diluted solution must be used immediately or stored at room temperature (20 °C-25 °C) or in a refrigerator (2 °C-8 °C). 
Razrijeđena otopina se mora odmah iskoristiti ili pohraniti na sobnoj temperaturi (20°C - 25°C) ili u hladnjaku (2°C - 8°C).
• Gently swirl the vial to aid dissolution. 
• Nježno vrtite bočicu kako biste pospješili otapanje.
No patients had an increase in QTcF interval > 500 msec. Grade 2 QT interval prolongation was reported in 2/164 (1%) patients. 
Nijedan bolesnik nije imao povećanje QTcF-intervala na > 500 ms.
The recommended BESPONSA dose was determined to be 1.8 mg/m2/cycle administered at a dose of 0.8 mg/m2 on Day 1 and 0.5 mg/m2 on Days 8 and 15 of a 28-day cycle with a dose reduction upon achieving CR/CRi. 
1,8 mg/m 2/ciklusu primijenjena u dozi od 0,8 mg/m 2 1. dana, te 0,5 mg/m 2 8. dana i 15. dana 28
Median OS; months [95% CI] 
; mjeseci [95% CI]
(NCI CTCAE) version 3.0. 
National Cancer Institute Common Terminology Criteria for Adverse Events, NCI CTCAE), verzija
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 definiran kao < 5% blasta u koštanoj srži i odsutnost leukemijskih blasta u perifernoj krvi, puni oporavak broja krvnih stanica u perifernoj krvi (trombociti ≥ 100 x 10
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. 
Prema EAC-u se CR definira kao < 5% blasta u koštanoj srži i odsutnost leukemičnih blasta u perifernoj krvi, potpuno obnavljanje broja krvnih stanica u perifernoj krvi (trombociti ≥ 100 × 10
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. 
Prema EAC-u se CRi definira kao < 5% blasta u koštanoj srži i odsutnost leukemičnih blasta u perifernoj krvi, djelomično obnavljanje broja krvnih stanica u perifernoj krvi (trombociti < 100 × 10
Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI). 
+), koje su prethodno neuspješno liječene barem jednim inhibitorom tirozin-kinaze (engl. tyrosine kinase inhibitor, TKI).
For patients with a high tumour burden, pre-medication to reduce uric acid levels and hydration is recommended prior to dosing (see section 4.4). 
Premedikacija u svrhu smanjenja razine mokraćne kiseline i hidratacija preporučuju se prije doziranja u bolesnika s velikim tumorskim opterećenjem (vidjeti dio 4.4).
Platelet count was ≥ 50 × 109/La 
9/l i broj trombocita se vrati na ≥ 50 × 10
The active ingredient in BESPONSA is inotuzumab ozogamicin. 
Djelatna tvar lijeka BESPONSA je inotuzumab ozogamicin.
PC: 
c
May be harmful to the teeth. 
Može biti štetno za zube.
These will require specific and sometimes preventive treatment. 
To zahtjeva specifično i ponekad preventivno liječenje.
From birth* to 13 days old 
Od rođenja* do 13 dana starosti
These events have often been transitory. 
Navedeni događaji su često bili prolazni.
The follow-up time was up to 24 weeks of age. 
Razdoblje praćenja bilo je do 24 tjedna starosti.
It also increases CD4 cell counts. 
Također povećava broj CD4 stanica.
Do not change the dose on your own. 
Ne mijenjajte sami dozu.
Your doctor will therefore be monitoring the effectiveness of your treatment. 
Vaš će liječnik nadzirati učinkovitost Vašeg liječenja.
The absolute bioavailability is 86±18%. 
Apsolutna bioraspoloživost je 86±18%.
Interaction studies have only been performed in adults. 
Ispitivanja interakcija provedena su samo u odraslih
Other medicines and Zerit 
Drugi lijekovi i Zerit
This rare, but very serious side effect occurs more often in women, particularly if very overweight. 
Ova rijetka, ali vrlo ozbiljna nuspojava javlja se češće u žena, naročito s prekomjernom težinom.
Zerit with food and drink 
Zerit s hranom i pićem
For this reason, it is important that you inform your doctor of any change in your health. 
Zbog toga je važno da obavijestite Vašeg liječnika o svim promjenama Vašeg zdravstvenog stanja.
a Number of patients evaluable. 
a broj evaluiranih bolesnika.
≤ 25 ml/min (including dialysis dependence*) 
≤ 25 ml/min (uključujući ovisnost o dijalizi *)
Do not worry if the solution remains slightly hazy after mixing with water; this is normal. 
Nemojte se brinuti ako otopina nakon miješanja s vodom ostane lagano magličasta; 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. 
Molimo Vas da slijedite strogo ove preporuke jer one Vam omogućuju najveću šansu da odgodite razvoj rezistencije na ovaj lijek.
Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machinery. 
Bolesnike bi trebalo uputiti da ako osjete ove simptome izbjegavaju potencijalno opasne zadatke kao što je vožnja ili upravljanje strojevima.
Date of last renewal: 20 April 2011 
Datum posljednje obnove odobrenja: 20 travnja 2011
If you are affected, do not drive and do not use any tools or machines. 
Ukoliko to primijetite, nemojte voziti niti rukovati alatom ili strojevima.
Similar effects have been observed with other nucleoside analogues. 
Slični učinci opaženi su i kod drugih analoga nukleozida.
Contact your doctor if you notice such changes. 
Obratite se svom liječniku ako primijetite takve promjene.
Instructions for preparation, see section 6.6. 
Za uputu o pripremi, vidjeti dio 6.6.
Continue to take this medicine until your doctor tells you otherwise. 
Nastavite uzimati lijek sve dok Vam Vaš liječnik ne kaže drugačije.
The mechanism and clinical significance of this difference are unknown. 
Mehanizam i klinička značajnost ove razlike nije poznat.
Stable for 30 days after reconstitution, when stored in a refrigerator. 
Stabilno 30 dana nakon pripreme za primjenu, kada se čuva u hladnjaku.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART. 
Tipično se takve reakcije pojavljuju tijekom prvih nekoliko tjedana ili mjeseci liječenja CART-om.
The AUC(inf) for stavudine was 61% of the AUC(inf) of the total circulating radioactivity. 
AUC(inf) stavudina iznosila je 61% AUC(inf) ukupne cirkulirajuće radioaktivnosti.
This should be taken into account in patients with diabetes mellitus. 
Ovo treba uzeti u obzir kod bolesnika sa šećernom bolesti.
Check with your doctor if you are not sure. 
Provjerite s Vašim liječnikom ili ljekarnikom ako niste sigurni.
Dosing recommendations are not available for neonates with a gestational age < 37 weeks. 
Preporuke za doziranje nisu dostupne za novorođenčad s gestacijskom dobi < 37 tjedana.
What Zerit looks like and content of the pack 
Kako Zerit izgleda i sadržaj pakiranja
It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms. 
Vjeruje se da su ti simptomi posljedica poboljšanja tjelesnog imunološkog odgovora, koje omogućava tijelu da se bori protiv infekcija koje mogu biti prisutne bez jasnih simptoma.
These CD4 cells play an important role in maintaining a healthy immune system to help fight infection. 
Ove CD4 stanice imaju važnu ulogu u održanju zdravog imunološkog sustava kojim se organizam brani od infekcije.
Zidovudine is therefore not recommended to be used in combination with stavudine. 
Stoga se ne preporuča upotreba zidovudina u kombinaciji sa stavudinom.
OTHER SPECIAL WARNING(S), IF NECESSARY Shake well before use. 
DRUGA POSEBNA UPOZORENJA AKO JE POTREBNO Dobro protresite prije uporabe.
If you accidentally miss a dose, then simply take your normal dose when the next one is due. 
Ako ste slučajno propustili dozu, onda jednostavno uzmite normalnu dozu kada je njeno vrijeme.
Aesica Queenborough Limited North Road, Queenborough Kent, ME11 5EL United Kingdom 
Aesica Queenborough Limited North Road, Queenborough Kent, ME11 5EL Ujedinjeno Kraljevstvo
Table 1: Efficacy Outcomes at Week 48 (Studies AI455-099 and AI455-096) 
Tablica 1: Rezultati djelotvornosti u 48. tjednu (ispitivanja AI455-099 i AI455-096)
It is not known whether stavudine is removed by peritoneal dialysis. 
Nije poznato da li se stavudin uklanja peritonealnom dijalizom.
Zerit should not be used during pregnancy unless clearly necessary. 
Zerit se ne treba davati tijekom trudnoće, osim ukoliko to nije nužno potrebno.
The patient should be instructed to shake the bottle well prior to measuring each dose. 
Bolesnika je potrebno uputiti da dobro protrese bocu prije odmjeravanja svake doze.
The prepared oral solution is stable for 30 days in a refrigerator (2°C -8°C). 
Pripremljena oralna otopina je stabilna 30 dana u hladnjaku (2°C -8°C).
Clinical experience in pregnant women is limited, but congenital anomalies and abortions have been reported. 
Kliničko iskustvo u trudnica je ograničeno, ali opisane su kongenitalne anomalije i pobačaji.
Patient weight 26-50 ml/min 
26-50 ml/min
The bottle should be shaken well, until the powder dissolves completely. 
Boca se mora dobro protresti, sve dok se prašak u potpunosti ne otopi.
What Zerit contains 
Što Zerit sadrži
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107c stavkom 7 Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenim na europskom internetskom portalu za lijekove.
Lactose intolerance: the hard capsule contains lactose. 
Intolerancija na laktozu: tvrda kapsula sadrži laktozu.
These capsules contain lactose. 
Ove kapsule sadrže laktozu.
The mother-infant pairs were randomised to receive either stavudine (N= 91), didanosine (N= 94), stavudine + didanosine (N= 88) or zidovudine (N= 89). 
Parovi majka-dojenče randomizirani su prema primanju stavudina (n= 91), didanozina (n= 94), stavudina + didanozina (n= 88) ili zidovudina (n= 89).
Peripheral neuropathy: up to 20% of patients treated with Zerit will develop peripheral neuropathy, often starting after some months of treatment. 
Periferna neuropatija: do 20% bolesnika liječenih lijekom Zerit razvit će perifernu neuropatiju, koja često počinje nakon nekoliko mjeseci liječenja.
Therefore, mothers should be instructed to discontinue breast-feeding prior to receiving Zerit. 
Stoga, majke treba uputiti da prekinu dojenje prije nego počnu primati Zerit.
Stavudine may cause dizziness and/or somnolence. 
Stavudin može uzrokovati omaglicu i/ili somnolenciju.
The number of reports in older infants was too small to identify a pattern. 
Broj opisanih slučajeva u starije dojenčadi bio je premalen za identifikaciju sličnog uzorka.
OTHER SPECIAL WARNING(S), IF NECESSARY 
DRUGA POSEBNA UPOZORENJA AKO JE POTREBNO
Because stavudine is not protein-bound, it is not expected to affect the pharmacokinetics of protein-bound medicines. 
Budući da se stavudin ne veže na proteine, ne očekuje se njegov učinak na farmakokinetiku lijekova koji se vežu na proteine.
Patient weight 
Težina bolesnika
This condition usually does not occur until a few months after onset of treatment. 
Ovo stanje se obično ne pojavljuje sve dok ne prođe nekoliko mjeseci nakon početka liječenja.
Lactic acidosis generally occurred after a few or several months of treatment. 
Laktična acidoza se općenito javljala nakon nekoliko mjeseci liječenja.
The clinical relevance of these findings suggest that stavudine should be generally avoided in the presence of TAMs, especially M41L and T215Y. 
Klinička važnost ovog nalaza ukazuje na to da bi se stavudin općenito morao izbjegavati kad su prisutne TAM, osobito M41L i T215Y.
If you take more Zerit than you should 
Ako uzmete više lijeka Zerit nego što ste trebali
Experience in adults treated with up to 12 times the recommended daily dosage revealed no acute toxicity. 
Na temelju iskustva s odraslima, doze do 12 puta veće od preporuče dnevne doze nisu izazvale nikakvu akutnu toksičnost.
Patients treated with Zerit have reported the following side effects: 
Bolesnici liječeni lijekom Zerit prijavili su sljedeće nuspojave:
What Zerit is and what it is used for 2. 
Što je Zerit i za što se koristi 2.
At least 14 days old and < 30 kg ≥ 30 kg 
Najmanje 14 dana starosti i < 30 kg ≥ 30 kg
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). 
Kod svakog slučaja zasebno treba uravnotežiti moguće dobrobiti smanjenja doze s mogućim rizicima - koji mogu proizaći iz ove mjere (niže intracelularne koncentracije).
If you have taken too many capsules or if someone accidentally swallows some, there is no immediate danger. 
Ako ste uzeli previše kapsula ili ako je netko slučajno progutao nekoliko, nema neposredne opasnosti.
If you stop taking Zerit The decision to stop using Zerit should be discussed with your doctor. 
Ako prestanete uzimati Zerit Odluka o prestanku uzimanja lijeka Zerit treba biti raspravljena s Vašim liječnikom.
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV. 
Navedeni nalazi ne utječu na trenutno važeće nacionalne preporuke o upotrebi antiretrovirusne terapije u trudnica u smislu prevencije vertikalnog prenošenja HIV-a.
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. 
Iako ne postoji dovoljno podataka za preporuku specifične doze lijeka Zerit u ovoj populaciji bolesnika, treba razmotriti smanjenje doze i/ili produženje razmaka među dozama razmjerno smanjenju u odraslih.
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). 
Dojenčad mlađa od 3 mjeseca: podaci o sigurnosti dostupni su iz kliničkih ispitivanja s trajanjem liječenja do 6 tjedana u 179 novorođenčadi i dojenčadi < 3 mjeseca (vidjeti dio 4.8).
Zerit may also be administered by carefully opening the hard capsule and mixing the contents with food. 
Zerit se također može uzimati tako da se tvrdu kapsulu pažljivo otvori i sadržaj kapsule pomiješa s hranom.
In addition, K65R has been reported in patients receiving stavudine/didanosine or stavudine/lamivudine, but not in patients receiving stavudine monotherapy. 
Osim toga, K65R je bila zabilježena u bolesnika koji su primali stavudin/didanozin ili stavudin/lamivudin, ali ne i u bolesnika koji su primali monoterapiju stavudinom.
The clinical significance of this is unknown. 
Klinički značaj navedenog nije poznat.
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. 
Ako ste uzeli Zerit za vrijeme trudnoće, Vaš liječnik može zatražiti redovite pretrage krvi i druge dijagnostičke pretrage, kako bi pratio razvoj Vašeg djeteta.
The safety and efficacy of stavudine has not been established in patients with significant underlying liver disorders. 
Sigurnost i djelotvornost stavudina nije potvrđena u bolesnika s postojećim značajnim poremećajima jetre.
In study AI455-094, performed in South-Africa, 362 mother-infant pairs were included in a prevention of mother-to-child-transmission study. 
Ispitivanje AI455-094, koje je provedeno u Južnoafričkoj Republici, uključilo je 362 para majkadojenče u ispitivanje prevencije prijenosa s majke na dijete.
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. 
U ispitivanju AI455-094 (vidjeti dio 4.6) razdoblje sigurnosnog praćenja bilo je ograničeno na samo šest mjeseci, što može biti nedovoljno za uočavanje dugoročnih podataka o neurološkim nuspojavama i mitohondrijalnoj toksičnosti.
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). 
Učestalost nuspojava definira se prema slijedećem prikazu učestalosti nuspojava: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10000 i < 1/1000); vrlo rijetko (< 1/10000).
Hepatic impairment: no initial dosage adjustment is necessary. 
Oštećenje jetre: početnu dozu nije potrebno prilagođavati.