natgillin/translations-raw huggingface dataset:
Values for Test and Reference are mean (% coefficient of variation). 
Vrednosti za test in referenco so srednje vrednosti (odstotek koeficienta variabilnosti).
Any inflammatory symptoms should be evaluated and treatment instituted when necessary. 
Kakršne koli vnetne simptome je treba oceniti in po potrebi uvesti zdravljenje.
Tenofovir concentrations not measured, no effect is expected. 
Koncentracij tenofovirja niso merili, učinki niso pričakovani.
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. 
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
The incidence of erythema multiforme or Stevens-Johnson syndrome was approximately 0.1%. 
Pojavnost multiformnega eritema ali Stevens-Johnsonovega sindroma je bila približno 0,1-odstotna.
This decrease in atazanavir Cmin might negatively impact the efficacy of atazanavir. 
To zmanjšanje atazanavirja Cmin lahko negativno vpliva na učinkovitost atazanavirja.
Table 3: Development of resistance in study GS-01-934 through week 144 
Tabela 3: Razvoj odpornosti v študiji GS-01-934 do 144. tedna
Use within 60 days after first opening. 
Porabite v 60 dneh po odprtju.
Similar results were found by other investigators, although the MPA plasma levels were more variable in the second study. 
Do podobnih rezultatov so prišli tudi drugi raziskovalci, čeprav so bile koncentracije MPA v plazmi v drugi študiji bolj spremenljive.
- if you have severe liver disease. 
- če imate hudo jetrno bolezen,
Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection. 
Zdravnika takoj obvestite o kakršnih koli novih ali nenavadnih simptomih po prenehanju zdravljenja, zlasti o simptomih, ki jih povezujete z okužbo z virusom hepatitisa B.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05 September 2017 
Datum prve odobritve: 05 September 2017
HORMONAL CONTRACEPTIVES Oral: 
HORMONSKA KONTRACEPCIJSKA SREDSTVA Peroralno:
You can also report side effects directly via the national reporting system listed in Appendix V By reporting side effects you can help provide more information on the safety of this medicine. 
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
Based on the different elimination pathways, no interaction is expected. 
Glede na različne poti izločanja medsebojno delovanje ni pričakovano.
*lower than recommended doses; similar findings are expected with recommended doses. 
* nižji od priporočenih odmerkov, podobno se pričakuje pri priporočenih odmerkih.
- if you have or have had kidney disease, or if tests have shown problems with your kidneys. 
- če imate ali ste imeli bolezen ledvic ali če so testi pokazali, da imate bolezni ledvic.
[To appear on outer carton only] 
[Navesti samo na zunanji ovojnini]
Write the date the bottle was opened on the label and/or carton in the space provided. 
Napišite datum odprtja plastenke na nalepko in/ali škatlo, v za to predviden prostor.
- if you have a history of mental illness, including depression, or of substance or alcohol abuse. 
- če ste kdaj imeli duševne bolezni, vključno z depresijo ali zlorabo alkohola in drugih substanc.
Antibiotics 
Antibiotiki
Mean percent change in AUC, Cmax, Cmin with 90% confidence intervals if available 
Povprečna sprememba odstotka pričakovane izpostavljenosti (AUC), Cmax, Cmin z 90-odstotnimi intervali zaupanja, če so na voljo
The incidence of neural tube defects in the general population ranges from 0.5-1 case per 1,000 live births. 
Pojavnost okvar nevralne cevi pri prebivalstvu na splošno je od 0,5 do 1 primera na 1000 živorojenih otrok.
It is important to tell your doctor or pharmacist if you are taking any of the following: 
Pomembno je, da zdravniku ali farmacevtu poveste, če jemljete katero koli izmed naslednjih zdravil:
Do not use this medicine after the expiry date which is stated on the bottle and carton after ‘EXP'. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake „EXP“.
Substitutions at RT positions 98, 100, 101, 108, 138, 188, 190 or 225 were also observed, but at lower frequencies, and often only in combination with K103N. 
Opazili so tudi substitucije pri RT na položajih 98, 100, 101, 108, 138, 188, 190 ali 225, vendar redkeje in pogosto le v kombinaciji s K103N.
Lopinavir concentrations: ↓ 30 
Koncentracije lopinavirja: ↓ 30
Open date: 
Datum odprtja:
Tell your doctor if you are taking other medicines which may damage your kidneys. 
Obvestite zdravnika, če jemljete druga zdravila, ki lahko škodijo ledvicam.
<for carton only> Open date: 
<samo za škatlo> Datum odprtja:
- if you have a history of liver disease, including chronic active hepatitis. 
- če ste v preteklosti imeli bolezen jeter, vključno s kroničnim aktivnim hepatitisom.
A risk to the infants cannot be excluded. 
Tveganja za dojenega novorojenčka/otroka ne moremo izključiti.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000). 
Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) ali redki (≥ 1/10.000 do < 1/1.000).
No effect (↔) equals a decrease in mean ratio estimate of ≤ 20% or increase in mean ratio estimate of ≤ 25%. 
Brez učinka (↔) je enako zmanjšanju ocene razmerja srednje vrednosti ≤ 20 % ali zvišanju ocene razmerja srednje vrednosti ≤ 25 %.
See ritonavir row below. 
Glejte vrstico o ritonavirju spodaj.
- any signs of skin rash. 
- kakršne koli znake kožnega izpuščaja.
These metabolites are essentially inactive against HIV-1. 
Ti presnovki so večinoma neaktivni proti virusu HIV1.
Confirmatory testing by a more specific method such as gas chromatography/mass spectrometry is recommended in such cases. 
V teh primerih je priporočeno izvesti potrjevalne preskuse z bolj specifično metodo, kot je plinska kromatografija/masna spektrometrija.
Some patients accidentally taking 600 mg efavirenz twice daily have reported increased nervous system symptoms. 
Nekateri bolniki, ki so pomotoma vzeli 600 mg efavirenza dvakrat na dan, so poročali o povečanju simptomov živčevja.
Efavirenz is an NNRTI of HIV-1. 
Efavirenz je NNRTI za HIV-1.
hepatic steatosis, hepatitis 
jetrna steatoza, hepatitis
Interaction not studied. 
Medsebojnega delovanja niso preučevali.
These tumours are unlikely to be of relevance to humans. 
Ni verjetno, da bi bili ti tumorji pomembni za človeka.
- Lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in every 1,000 patients) but serious side effect that can be fatal. 
- Laktacidoza (čezmerna količina mlečne kisline v krvi) je redek (pojavi se lahko pri največ 1 od 1.000 bolnikov), vendar resen neželeni učinek, ki je lahko smrten.
Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving and operating machinery. 
Bolnike je treba poučiti, naj se v primeru teh simptomov izogibajo potencialno nevarnim opravilom, kakršna sta vožnja ali upravljanje strojev.
Expected: Voxilaprevir:↓ 
Pričakovano: voksilaprevir:↓
- if your doctor has told you that you have high or low levels of electrolytes such as potassium or magnesium in your blood. 
če vam je zdravnik povedal, da imate v krvi visok ali nizek nivo elektrolitov, kot sta kalij ali magnezij,
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products. 
V primeru sočasnega protivirusnega zdravljenja hepatitisa B ali C glejte tudi ustrezne Povzetke glavnih značilnosti teh zdravil.
However, as would be expected in this patient population, elevations in AST and ALT occurred more frequently than in the general HIV infected population. 
Vendar so se po pričakovanju zvišanja AST in ALT pri tej skupini bolnikov pojavila pogosteje kot pri splošni populaciji bolnikov, okuženih z virusom HIV.
Pharmacotherapeutic group: Antiviral for systemic use, antivirals for treatment of HIV infections, combinations, ATC code: J05AR06. 
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, protivirusna zdravila za zdravljenje infekcij s HIV, kombinacije, oznaka ATC: J05AR06.
Stayed on original treatment regimen (N=97) n/N (%) 
Bolniki, ki so ostali na prvotnem zdravljenju (N = 97) n/N (%)
Refer to the Summary of Product Characteristics for the medicinal product containing maraviroc. 
Glejte Povzetke glavnih značilnosti zdravila, ki vsebuje maravirok.
Cross-resistance profiles for efavirenz, nevirapine and delavirdine in vitro demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs. 
Profili navzkrižne odpornosti na efavirenz, nevirapin in delavirdin in vitro so pokazali, da substitucija K103N povzroči izgubo občutljivosti za vse tri NNRTI.
As a general rule, it is recommended that HIV infected women do not breast-feed their infants in order to avoid transmission of HIV to the infant. 
Na splošno je priporočljivo, da ženske, okužene z virusom HIV, ne dojijo, da se prepreči prenos virusa HIV na dojenčka.
As neural tube defects occur within the first 4 weeks of foetal development (at which time neural tubes are sealed), this potential risk would concern women exposed to efavirenz during the first trimester of pregnancy. 
Ker do okvar nevralne cevi pride samo v prvih 4 tednih razvoja plodu (ko se nevralne cevi zaprejo), bi to potencialno tveganje zadevalo ženske, izpostavljene efavirenzu v prvem trimesečju nosečnosti.
In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects. 
Pri otrocih, katerih matere so med nosečnostjo jemale nukleozidne zaviralce reverzne transkriptaze (NRTI), je korist zaščite pred virusom HIV odtehtala tveganje za neželene učinke.
Both the K65R and M184V/I mutation remain fully susceptible to efavirenz. 
Tako mutacija K65R kot M184V/I pa ostajata popolnoma občutljivi za efavirenz.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement. 
Bolnikom je treba svetovati, naj poiščejo zdravniško pomoč, če se pojavijo bolečine v sklepih, togost sklepov ali težave pri gibanju.
Tenofovir is primarily excreted by the kidneys by both filtration and an active tubular transport system with approximately 70 to 80% of the dose excreted unchanged in urine following intravenous administration. 
Tenofovir se primarno izloča skozi ledvici tako z glomerulno filtracijo kot z aktivnim tubularnim transportnim sistemom, pri čemer se po intravenskem vnosu približno 70 do 80 % odmerka izloči nespremenjenega z urinom.
The oral bioavailability of tenofovir from tenofovir disoproxil in fasted patients was approximately 25%. 
Peroralna biološka uporabnost tenofovirja iz dizoproksiltenofovirata pri teščih bolnikih je bila približno 25 %.
One tablet taken each day by mouth. 
Priporočeni odmerek je: ena tableta na dan, ki jo zaužijete skozi usta.
The clinical outcome of this observed reduction of boceprevir trough concentrations has not been directly assessed. 
Klinični izid tega opazovanega zmanjšanja najmanjše koncentracije boceprevira še ni bil neposredno ovrednoten.
117 Allée Des Parcs, 69 800 Saint-Priest, France 
117 Allée Des Parcs, 69 800 Saint-Priest, Francija
- Independent of a history of liver disease, your doctor will consider regular blood tests to check how your liver is working. 
- Neodvisno od tega, ali ste prej kdaj imeli jetrno bolezen, bo vaš zdravnik razmislil o rednih krvnih preiskavah, da preveri, kako delujejo vaša jetra.
Verapamil, Felodipine, Nifedipine and Nicardipine 
Verapamil, felodipin, nifedipin in nikardipin
It is not considered to be causally associated with tenofovir disoproxil in the absence of this condition. 
Ne obravnava se, kot da je vzročno povezana s dizoproksiltenofoviratom v odsotnosti tega stanja.
abnormal dreams, insomnia 
nenormalne sanje, nespečnost
There were insufficient data to determine whether moderate or severe hepatic impairment (Child-Pugh-Turcotte Class B or C) affects efavirenz pharmacokinetics. 
Ni bilo dovolj podatkov, da bi ugotovili, ali zmerna ali huda jetrna okvara (razreda B ali C po Child- PughTurcotteovi lestvici) vpliva na farmakokinetiko efavirenza.
These problems tend to occur more often in those who have a history of mental illness. 
Te težave se pogosteje pojavijo pri bolnikih, ki so v preteklosti imeli duševno bolezen.
Patients should be advised that if they experience symptoms such as severe depression, psychosis or suicidal ideation, they should contact their doctor immediately to assess the possibility that the symptoms may be related to the use of efavirenz, and if so, to determine whether the risk of continued therapy outweighs the benefits (see section 4.8). 
Bolnikom je treba svetovati, naj se v primeru pojava simptomov, kot so huda oblika depresije, psihoza ali misel na samomor, nemudoma posvetujejo s svojim zdravnikom, ki bo ocenil, ali so simptomi povezani z jemanjem efavirenza, in če je tako, odločil, ali je tveganje nadaljevanja zdravljenja z efavirenzom večje od koristi (glejte poglavje 4.8).
In other studies (prospective and cross-sectional), the most pronounced decreases in BMD were seen in patients treated with tenofovir disoproxil as part of a regimen containing a boosted protease inhibitor. 
V drugih študijah (prospektivne in presečne) so najbolj izrazito zmanjšanje MGK opazili pri bolnikih, zdravljenih z dizoproksiltenofoviratom kot delom režima, ki je vseboval okrepljenega zaviralca proteaze.
• itchy rash to the skin caused by a reaction to sunlight 
• srbeč kožni izpuščaj, ki ga povzroči reakcija na sončno svetlobo.
This medicine is available in plastic bottles containing a desiccant labelled ‘DO NOT EAT' and 30 tablets and in multipacks of 90 tablets comprising 3 bottles, each containing 30 tablets. 
To zdravilo je na voljo v plastenkah s sušilnim sredstvom z oznako „DO NOT EAT“, ki vsebujejo 30 filmsko obloženih tablet in v skupnih pakiranjih z 90 filmsko obloženimi tabletami, ki vsebujejo 3 plastenke s 30 filmsko obloženimi tabletami.
Dihydroartemisinin (active metabolite): 
Dihidroartemizinin (aktivni presnovek):
It contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'. 
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘'brez natrija''.
Rare completed suicide3,4, delusion3,4, neurosis3,4 
Redki storjen samomor3,4, deluzija3,4, nevroza3,4
If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment. 
Če opazite kakršne koli simptome okužbe ali druge simptome, na primer mišično oslabelost, oslabelost, ki se najprej pojavi v dlaneh in stopalih in nato širi proti trupu, palpitacije, tremor ali hiperaktivnost, zaradi potrebnega zdravljenja nemudoma obvestite zdravnika.
- signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating or abnormal dreaming. 
- znake omotice, težave pri spanju, zaspanost, težave s koncentracijo ali nenormalne sanje.
Most cases occurred in patients who already had liver disease, but there have been a few reports in patients without any existing liver disease 
Ta učinek se je pojavil večinoma pri bolnikih, ki so že imeli jetrno bolezen, vendar pa je bilo nekaj poročanj o pojavu pri bolnikih, ki prej niso imeli jetrne bolezni;
Skin and subcutaneous tissue disorders: Very common rash (moderate-severe, 11.6%, all grades, 18%)3 
Bolezni kože in podkožja: Zelo pogosti izpuščaj (zmeren-hud, 11,6 %, vse stopnje, 18 %)3
Emtricitabine is primarily excreted by the kidneys with complete recovery of the dose achieved in urine (approximately 86%) and faeces (approximately 14%). 
Emtricitabin se primarno izloča skozi ledvici - celoten odmerek se izloči z urinom (približno 86 %) in blatom (približno 14 %).
- Medicines used to lower blood fats (also called statins): Atorvastatin, pravastatin, simvastatin. 
- Zdravila za znižanje količine maščob v krvi (imenovana tudi statini): atorvastatin, pravastatin, simvastatin.
These drugs include: - antiarrhythmics of classes IA and III, - neuroleptics, antidepressive agents, - certain antibiotics including some agents of the following classes: macrolides, 
Med taka zdravila sodijo: - antiaritmiki razreda IA in III, - nevroleptiki, antidepresivi, - določeni antibiotiki, vključno z učinkovinami iz naslednjih razredov: makrolidi,
Rare osteomalacia (manifested as bone pain and infrequently contributing to fractures)2,4, myopathy2 
Redki alacija (ki se kaže kot bolečine v kosteh in redko prispeva k zlomom)2,4, miopatija2
If you think you may have lactic acidosis, contact your doctor immediately. 
Če menite, da imate laktacidozo, se takoj posvetujte s svojim zdravnikom.
In uninfected volunteers, multiple doses of 200 to 400 mg per day for 10 days resulted in a lower than predicted extent of accumulation (22 to 42% lower) and a shorter terminal half-life of 40 to 55 hours (single dose half-life 52 to 76 hours). 
Pri neokuženih prostovoljcih so 10-dnevni večkratni odmerki 200-400 mg dnevno povzročili manjšo akumulacijo zdravila od pričakovane (za 22-42 % manjšo) in krajši končni razpolovni čas 40-55 ur (razpolovni čas enkratnega odmerka je 52-76 ur).
This medicinal product contains 7.5 mg of sodium metabisulfite per dose, which may rarely cause severe hypersensitivity reactions and bronchospasm. 
To zdravilo vsebuje 7,5 mg natrijevega metabisulfita na odmerek, kar lahko redko povzroči hude preobčutljivostne reakcije in bronhospazem.
Mylan Hungary Kft Mylan utca 1, Komárom 2900, Hungary 
Mylan Hungary Kft Mylan utca 1, Komárom 2900, Madžarska
- Medicines used to prevent organ transplant rejection (also called immunosuppressants), such as cyclosporine, sirolimus or tacrolimus. 
- Zdravila za preprečevanje zavrnitve presajenih organov (imenovana tudi imunosupresivi), kakršna so ciklosporin, sirolimus ali takrolimus.
Laboratory tests should be performed to evaluate their liver disease at periodic intervals (see section 4.2). 
Za ocenjevanje njihove jetrne bolezni je treba redno opravljati laboratorijske preiskave (glejte poglavje 4.2).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Approximately 14 to 34% of a radiolabelled dose of efavirenz was recovered in the urine and less than 1% of the dose was excreted in urine as unchanged efavirenz. 
Približno 14 do 34 % radioaktivno označenega odmerka efavirenza se je izločilo z urinom, manj kot 1 % odmerka pa se je z urinom izločilo v obliki nespremenjenega efavirenza.
- if you have a heart disorder, such as abnormal electrical signal called prolongation of the QT interval. 
če imate bolezen srca, kot je nenormalen električni signal, kar se imenuje podaljšanje intervala QT.
- dry mouth - incoherent speech - increased appetite - libido decreased - myalgia 
- suha usta - nepovezano govorjenje - povečan tek - zmanjšanje spolne sle - mialgija
Carbamazepine plasma levels should be monitored periodically. 
Redno je treba spremljati koncentracije karbamazepina v plazmi.
Findings in the rat and monkey studies indicated that there was a substance-related decrease in intestinal absorption of phosphate with potential secondary reduction in BMD. 
Ugotovitve študij pri podganah in opicah so pokazale, da je prišlo do z učinkovino povezanega zmanjšanja črevesne absorpcije fosfata s potencialnim sekundarnim zmanjšanjem BMD.
Reproductive toxicity studies in rats and rabbits showed no effects on mating, fertility, pregnancy or foetal parameters. 
Študije vpliva na sposobnost razmnoževanja pri podganah in kuncih niso pokazale učinka na parjenje, plodnost, nosečnost ali parametre zarodka.
Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucosegalactose malabsorption should not take this medicine. 
Bolniki z redkimi dednimi težavami, kot so intoleranca za galaktozo, skupno zmanjšanje aktivnosti laktaze ali malabsorpcija glukoze/galaktoze tega zdravila ne smejo jemati.
Genotoxicity studies revealed positive results in the in vitro mouse lymphoma assay, equivocal results in one of the strains used in the Ames test, and weakly positive results in an UDS test in primary rat hepatocytes. 
Študije genotoksičnosti so pokazale pozitivne rezultate pri testu mišjega limfoma in vitro, dvoumne rezultate pri enem od sevov, ki so ga uporabili pri Amesovem testu, in šibko pozitivne rezultate pri testu UDS pri primarnih podganjih hepatocitih.
This may stop your medicines from working properly, or may make any side effects worse. 
Zdravilu lahko preneha pravilno delovati ali pa se okrepijo neželeni učinki.
Interrupting treatment with efavirenz/emtricitabine/tenofovir disoproxil should also be considered in case of progressive decline of renal function when no other cause has been identified. 
O prekinitvi zdravljenja z efavirenzom/emtricitabinom/dizoproksiltenofoviratom je treba razmisliti tudi v primeru progresivnega upada ledvične funkcije, če ni bil ugotovljen noben drug razlog.
EXP: Once opened use within 60 days. 
EXP: Po odprtju porabiti v 60 dneh.
Cmin: ↑ 51% (↑ 37 to ↑ 66) Higher tenofovir concentrations could potentiate tenofovirassociated adverse events, including renal disorders. 
Cmin: ↑ 51 % (↑ 37 do ↑ 66) Višje koncentracije tenofovirja bi lahko okrepile neželene učinke, povezane s tenofovirjem, vključno z motnjami delovanja ledvic.
This loss is due to significant decreases in elbasvir/grazoprevir plasma concentrations caused by CYP3A4 or P gp induction. 
Ta izguba je posledica pomembnega zmanjšanja koncentracij elbasvirja/grazoprevirja v plazmi, ki jih povzroči indukcija CYP3A4 ali P-gp.
1 Other efavirenz resistance mutations included A98G (n=1), K103E (n=1), V179D (n=1), and M230L (n=1). 
1 Druge mutacije za odpornost na efavirenz so vključevale A98G (n = 1), K103E (n = 1), V179D (n = 1) in M230L (n = 1).
Monitoring of renal function may be indicated, particularly in patients with underlying systemic or renal disease, or in patients taking nephrotoxic agents. 
Spremljanje ledvične funkcije je lahko indicirano, zlasti pri blonikih z že obstoječo sistemsko ali ledvično boleznijo ali pri bolnikih, ki jemljejo nefrotoksična zdravila.
These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, who present with severe clinical findings of unknown etiology, particularly neurologic findings. 
Te ugotovitve je treba upoštevati pri vseh otrocih, ki so bili in utero izpostavljeni nukleozidnim in nukleotidnim analogom, pri katerih se pojavijo resne klinične ugotovitve neznanega vzroka, zlasti nevrološke.