natgillin/translations-raw huggingface dataset:
Frequent bowel movements Upper abdominal pain* Gastroesophageal reflux disease 
pogosti bruhanje* dispepsija pogosto iztrebljanje bolečina v zgornjem delu trebuha* gastroezofagealna refluksna bolezen občasni krvavitev v prebavilih
In a combined female mouse fertility and embryo-foetal developmental toxicity study with oral dosages of 10, 20, 40, and 80 mg/kg/day, a prolongation of oestrous cycles and increased time to mating were observed at 20 mg/kg/day and above; despite this, all mice mated and pregnancy rates were unaffected. 
V združeni študiji toksičnosti za plodnost mišjih samic in razvoj zarodka in plodu s peroralnimi odmerki 10, 20, 40 in 80 mg/kg/dan so ugotovili podaljšanje estrusnih ciklov in podaljšanje časa do parjenja pri 20 mg/kg/dan in večjih odmerkih; kljub temu so se vse miši parile in pogostnost brejosti ni bila prizadeta.
Respiratory, thoracic, and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti kašelj
Each film-coated tablet contains 57 mg of lactose (as lactose monohydrate). 
Ena filmsko obložena tableta vsebuje 57 mg laktoze (v obliki laktoze monohidrata).
Each film-coated tablet contains 171 mg of lactose (as lactose monohydrate). 
Ena filmsko obložena tableta vsebuje 171 mg laktoze (v obliki laktoze monohidrata).
The pharmacokinetics of apremilast and its major metabolite M12 are not affected by moderate or severe hepatic impairment. 
Zmerna ali huda okvara jeter ne vpliva na farmakokinetiko apremilasta in njegovega glavnega presnovka M12.
Each film-coated tablet contains 114 mg of lactose (as lactose monohydrate). 
Ena filmsko obložena tableta vsebuje 114 mg laktoze (v obliki laktoze monohidrata).
In both studies, the mean percent improvement in PASI from baseline remained stable during the Randomised Treatment Withdrawal Phase for patients re-randomised to apremilast at week 32 (Table 5). 
V obeh študijah je pri bolnikih, ki so jih ponovno randomizirali na apremilast po 32 tednih, povprečno odstotno izboljšanje PASI od izhodišča v fazi odtegnitve randomiziranega zdravljenja ostalo stabilno (preglednica 5).
Of the patients with at least a PASI-50 response who were re-randomised to placebo at week 32, 24.2% were PASI-50 responders at week 52. 
Od bolnikov z odzivom vsaj PASI 50, ki so jih po 32 tednih ponovno randomizirali na placebo, jih je po 52 tednih 24,2 % imelo odziv PASI 50.
The dose of apremilast should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance of less than 30 mL per minute estimated by the Cockcroft-Gault equation). 
Pri bolnikih s hudo okvaro ledvic (očistek kreatinina manjši od 30 ml/min, ocenjen s Cockcroft-Gaultovo enačbo) je treba zmanjšati odmerek apremilasta na 30 mg enkrat dnevno.
Otezla 10 mg film-coated tablets Otezla 20 mg film-coated tablets Otezla 30 mg film-coated tablets apremilast 
Otezla 10 mg filmsko obložene tablete Otezla 20 mg filmsko obložene tablete Otezla 30 mg filmsko obložene tablete apremilast
Common 
ZDRUŽENE
Patients who were re-randomised to placebo and who lost PASI-75 response (ESTEEM 1) or lost 50% of the PASI improvement at week 32 compared to baseline (ESTEEM 2) were retreated with apremilast 30 mg twice daily. 
Bolnike, ki so bili ponovno randomizirani na placebo in ki so izgubili odziv PASI 75 (ESTEEM 1) ali ki so izgubili odziv PASI 50 (ESTEEM 2) v 32. tednu v primerjavi z izhodiščem, so še enkrat zdravili z apremilastom 30 mg dvakrat dnevno.
20 mg (brown) 
20 mg (rjava)
In Study ESTEEM 1, approximately 61% of patients re-randomised to apremilast at week 32 had a PASI-75 response at week 52. 
V študiji ESTEEM 1 je imelo približno 61 % bolnikov, ki so jih po 32 tednih ponovno randomizirali na apremilast, po 52 tednih odziv PASI 75.
• Otezla is for oral use. 
• Zdravilo Otezla je namenjeno za peroralno uporabo.
Proportion of patients with ACR responses in studies PALACE 1, PALACE 2 and PALACE 3 and pooled studies at week 16 
Delež bolnikov z odzivi po ACR v 16. tednu v študijah PALACE 1, PALACE 2 in PALACE 3 ločeno in združeni iz vseh treh študij.
Of the patients with at least a PASI-75 response who were re-randomised to placebo at week 32 during a Randomised Treatment Withdrawal Phase, 11.7% were PASI-75 responders at week 52. 
Od bolnikov z odzivom vsaj PASI 75, ki so jih po 32 tednih med fazo odtegnitve randomiziranega zdravljenja ponovno randomizirali na placebo, jih je po 52 tednih 11,7 % imelo odziv PASI 75.
• The treatment initiation pack is a folding wallet containing 27 film-coated tablets: 4 x 10 mg tablets, 4 
• Pakiranje za začetek zdravljenja je zgibanka, ki vsebuje 27 filmsko obloženih tablet: 4 x 10 mg tablete, 4 x 20 mg tablete in 19 x 30 mg tablet.
• The 20 mg film-coated tablet also contains iron oxide yellow (E172). 
• 20-miligramska filmsko obložena tableta vsebuje tudi rumeni železov oksid (E172).
Otezla has also been shown to improve the quality of life in patients with psoriasis or psoriatic arthritis. 
Prav tako se je izkazalo, da zdravilo Otezla pri bolnikih s psoriazo ali psoriatičnim artritisom izboljšuje kakovost življenja.
There was no pharmacokinetic interaction between apremilast and methotrexate in psoriatic arthritis patients. 
Pri bolnikih s psoriatičnim artritisom ni bilo farmakokinetičnih interakcij med apremilastom in metotreksatom.
Upper respiratory tract infection Nasopharyngitis* 
Infekcijske in parazitske bolezni pogosti bronhitis okužba zgornjih dihal nazofaringitis*
• Otezla 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast. 
• Otezla 20 mg filmsko obložene tablete: ena filmsko obložena tableta vsebuje 20 mg apremilasta.
The 30 mg tablets also contain iron oxide yellow (E172) and iron oxide black (E172). 
30-miligramske tablete vsebujejo tudi rumeni železov oksid (E172) in črni železov oksid (E172).
Diarrhoea, nausea, and vomiting 
Driska, navzea in bruhanje
Among patients who were initially randomised to apremilast 30 mg twice daily treatment, ACR 20/50/70 response rates were maintained through week 52 in the pooled studies PALACE 1, PALACE 2 and PALACE 3 (Figure 1). 
Med bolniki, ki so bili v začetku randomizirani na zdravljenje z apremilastom 30 mg dvakrat dnevno, so odzivi ACR 20/50/70 v združenih študijah PALACE 1, PALACE 2 in PALACE 3 trajali do 52. tedna zdravljenja (slika 1).
Clinical improvement measured by sPGA, PASI-50 and PASI-90 responses were also demonstrated at week 16. 
Po 16 tednih zdravljenja je bilo dokazano tudi klinično izboljšanje, merjeno z odzivi sPGA, PASI 50 in PASI 90.
Week ACR 50 Week ACR 70 Week 
Endpoint ACR 50 ACR 70
In Studies ESTEEM 1 and ESTEEM 2, significant improvements in scalp psoriasis of at least moderate severity (≥3), measured by the proportion of patients achieving Scalp Psoriasis Physician's Global Assessment (ScPGA) of clear (0) or minimal (1) at week 16, were observed in patients receiving apremilast compared to placebo-treated patients (p< 0.0001 for both studies). 
V študijah ESTEEM 1 in ESTEEM 2 so pri bolnikih, ki so prejemali apremilast, v primerjavi z bolniki, ki so prejemali placebo, opazili pomembno izboljšanje psoriaze lasišča vsaj zmerne izraženosti (≥3), izmerjene z deležem bolnikov, ki so po 16 tednih dosegli zdravnikovo globalno oceno psoriaze lasišča (ScPGA) brez vidnih bolezenskih sprememb (0) ali skoraj brez vidnih bolezenskih sprememb (1) (p< 0,0001 v obeh študijah).
• The 30 mg film-coated tablet also contains iron oxide yellow (E172) and iron oxide black (E172). 
• 30-miligramska filmsko obložena tableta vsebuje tudi rumeni železov oksid (E172) in črni železov oksid (E172).
• Otezla 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast. 
• Otezla 30 mg filmsko obložene tablete: ena filmsko obložena tableta vsebuje 30 mg apremilasta.
• This is a total daily dose of 60 mg. By the end of day 6 you will have reached this recommended dose. 
Ta priporočeni odmerek boste dosegli ob koncu 6. dne.
In addition, at week 32, subjects who did not achieve a PASI-75 response in ESTEEM 1, or a PASI-50 response in ESTEEM 2, were permitted to use topical psoriasis therapies and/or phototherapy in addition to apremilast 30 mg twice daily treatment. 
Preskušanci, ki do 32. tedna niso dosegli odziva PASI 75 v študiji ESTEEM 1 ali odziva PASI 50 v študiji ESTEEM 2, so smeli poleg zdravljenja z apremilastom 30 mg dvakrat dnevno uporabljati lokalna zdravila za psoriazo in/ali fototerapijo.
Accumulation is minimal when apremilast is administered once daily and approximately 53% in healthy subjects and 68% in patients with psoriasis when administered twice daily. 
Kopičenje je minimalno, če dajemo apremilast enkrat na dan, in približno 53 % pri zdravih preskušancih in 68 % pri bolnikih s psoriazo, kadar ga dajemo dvakrat na dan. Sočasno dajanje apremilasta s hrano ne spreminja njegove biološke uporabnosti, zato lahko apremilast dajemo s hrano ali brez nje.
Each film-coated tablet contains 20 mg of apremilast. 
Ena filmsko obložena tableta vsebuje 20 mg apremilasta.
• Otezla 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast. 
• Otezla 10 mg filmsko obložene tablete: ena filmsko obložena tableta vsebuje 10 mg apremilasta.
bN is based on subjects with moderate or greater scalp psoriasis at baseline who were re-randomised to APR 30 twice daily at week 32. 
bN temelji na preskušancih z zmerno ali hudo psoriazo lasišča v izhodišču, ki so jih po 32 tednih ponovno randomizirali na APR 30 dvakrat na dan. Preskušance z manjkajočimi podatki so upoštevali, kot da se niso odzvali na zdravljenje.
The 20 mg tablets also contain iron oxide yellow (E172). 
20-miligramske tablete vsebujejo tudi rumeni železov oksid (E172).
Bronchitis 
ZDRAVILOM
Each film-coated tablet contains 30 mg of apremilast. 
Ena filmsko obložena tableta vsebuje 30 mg apremilasta.
*p ≤ 0.01 for apremilast vs. placebo **p ≤ 0.001 for apremilast vs. placebo a N is the number of patients as randomised and treated 
**p ≤ 0,001 za apremilast proti placebu.
In studies PALACE 1, PALACE 2 and PALACE 3, significant improvements were demonstrated in healthrelated quality of life, as measured by the changes from baseline in the physical functioning (PF) domain of the Short Form Health Survey version 2 (SF-36v2), and in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-fatigue) scores in patients treated with apremilast compared to placebo at weeks 16 and 24. 
Merili so spremembe v telesnem delovanju (PF - Physical Functioning) s pomočjo kratkega vprašalnika o zdravstvenem stanju, verzija 2 (SF-36v2), in funkcijsko oceno zdravljenja kronične bolezni - utrujenost (FACIT - utrujenost; Functional Assessment of Chronic Illness Therapy - Fatigue) pri bolnikih, zdravljenih z apremilastom v primerjavi s placebom, od izhodišča do 16. in 24. tedna.
Each film-coated tablet contains 10 mg of apremilast. 
Ena filmsko obložena tableta vsebuje 10 mg apremilasta.
NAME OF THE MEDICINAL PRODUCT Otezla 30 mg tablets apremilast 
IME ZDRAVILA Otezla 30 mg tablete apremilast
No dose adjustment is necessary for patients with hepatic impairment. 
Pri bolnikih z okvaro jeter prilagajanje odmerka ni potrebno.
• frequent bowel movements 
• pogosto iztrebljanje blata,
Nervous system disorders 
Načrt titriranja odmerka
Otezla 10 mg film-coated tablets 
Otezla 10 mg filmsko obložene tablete
The proportion of patients with ACR 20/50/70 (responses in studies PALACE 1, PALACE 2 and PALACE 3, and the pooled data for studies PALACE 1, PALACE 2 and PALACE 3) for apremilast 30 mg twice daily at week 16 are shown in Table 3. 
Delež bolnikov, pri katerih je prišlo v 16. tednu zdravljenja z apremilastom 30 mg dvakrat dnevno do odzivov ACR 20/50/70 (odzivi v študijah PALACE 1, PALACE 2 in PALACE 3 ločeno ter združeni podatki za študije PALACE 1, PALACE 2 in PALACE 3), je prikazan v preglednici 3.
DMARDs N=162 
N=162
Among patients who were initially randomised to apremilast 30 mg twice daily treatment, the change from baseline in the HAQ-DI score at week 52 was -0.333 in the apremilast 30 mg twice daily group in a pooled analysis of the open label phase of studies PALACE 1, PALACE 2 and PALACE 3. 
Pri bolnikih, ki so bili v začetku randomizirani na zdravljenje z apremilastom 30 mg dvakrat dnevno, je bila v 52. tednu v združeni analizi odprte faze študij PALACE 1, PALACE 2 in PALACE 3 v tej skupini sprememba rezultata HAQ-DI od izhodišča -0,333.
DMARDs N=168 
N=168
DMARDs N=169 
N=169
Otezla 20 mg film-coated tablets 
Otezla 20 mg filmsko obložene tablete
Reductions in maternal body weight and weight gain, and one death associated with difficulty in delivering pups were observed at 300 mg/kg/day. 
Pri odmerku 300 mg/kg/dan so opazili zmanjšanje in zvečanje materine telesne mase in en primer smrti, povezan z oteženo skotitvijo mladičev.
croscarmellose sodium and magnesium stearate. 
Jedro tablete mikrokristalna celuloza laktoza monohidrat premreženi natrijev karmelozat magnezijev stearat
What plaque psoriasis is 
Kaj je psoriaza v plakih
DMARDs N=167 
N=167
Otezla 30 mg film-coated tablets 
Otezla 30 mg filmsko obložene tablete
Otezla 30 mg tablets apremilast 
Otezla 30 mg filmsko obložene tablete apremilast
Change in Pruritus VASf (mm), mean± SD Change in DLQIg, mean± SD 
PASI 90, n (%) odstotna sprememba BSAe povprečje± SD sprememba pruritusa VASf (mm), povprečje ±
No dose adjustment is needed in patients with mild and moderate renal impairment. 
Pri bolnikih z blago in zmerno okvaro ledvic prilagajanje odmerka ni potrebno.
• hives (urticaria) 
• koprivnica (urtikarija),
The Otezla 20 mg film-coated tablet is a brown, diamond shaped film-coated tablet with “APR” engraved on one side and “20” on the opposite side. 
Otezla 20 mg filmsko obložena tableta je rjava filmsko obložena tableta v obliki romba z vtisnjenim napisom “APR” na eni strani in “20” na drugi strani.
Pink, diamond shaped 10 mg film-coated tablet of 8 mm length with “APR” engraved on one side and “10” on the opposite side. 
Rožnata 10 mg filmsko obložena tableta v obliki romba, dolžine 8 mm, z vtisnjenim napisom “APR” na eni strani in “10” na drugi strani.
The Otezla 10 mg film-coated tablet is a pink, diamond shaped film-coated tablet with “APR” engraved on one side and “10” on the opposite side. 
Otezla 10 mg filmsko obložena tableta je rožnata filmsko obložena tableta v obliki romba z vtisnjenim napisom “APR” na eni strani in “10” na drugi strani.
• stomach pain 
• bolečina v želodcu,
Decreased appetite* 
Presnovne in prehranske motnje pogosti zmanjšan apetit*
Brown, diamond shaped 20 mg film-coated tablet of 10 mm length with “APR” engraved on one side and “20” on the opposite side. 
Rjava 20 mg filmsko obložena tableta v obliki romba, dolžine 10 mm, z vtisnjenim napisom “APR” na eni strani in “20” na drugi strani.
PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet 
FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta 56 filmsko obloženih tablet 168 filmsko obloženih tablet
The Otezla 30 mg film-coated tablet is a beige, diamond shaped film-coated tablet with “APR” engraved on one side and “30” on the opposite side. 
Otezla 30 mg filmsko obložena tableta je bež filmsko obložena tableta v obliki romba z vtisnjenim napisom “APR” na eni strani in “30” na drugi strani.
Cyclic AMP also modulates levels of anti-inflammatory cytokines such as IL-10.These pro- and anti-inflammatory mediators have been implicated in psoriatic arthritis and psoriasis. 
Ciklični AMP tudi modulira koncentracije protivnetnih citokinov, npr. IL-10.
Titanium dioxide (E171) 
Filmska obloga polivinilalkohol titanov dioksid (E171) makrogol (3350) smukec rdeči železov oksid (E172)
Placebo 
placebo DMARDs
Beige, diamond shaped 30 mg film-coated tablet of 12 mm length with “APR” engraved on one side and “30” on the opposite side. 
Bež 30 mg filmsko obložena tableta v obliki romba, dolžine 12 mm, z vtisnjenim napisom “APR” na eni strani in “30” na drugi strani.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg of apremilast. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 30 mg apremilasta.
Musculoskeletal and connective tissue disorders 
Bolezni mišičnoskeletnega sistema in vezivnega tkiva pogosti bolečina v hrbtu*
How to store Otezla 
Kako jemati zdravilo Otezla
• weight loss 
• izguba telesne mase,
Underweight patients 
Bolniki s premajhno telesno maso
PASIc 75, n (%) sPGAd of Clear or Almost Clear, n (%) PASI 50, n (%) PASI 90, n (%) Percent Change BSAe (%) mean± SD 
N PASIc 75, n (%)
Infections and infestations 
Razvoj zarodka in plodu
In Studies ESTEEM 1 and ESTEEM 2, significant improvements (reductions) in nail psoriasis, as measured by the mean percent change in Nail Psoriasis Severity Index (NAPSI) from baseline, were observed in patients receiving apremilast compared to placebo-treated patients at week 16 (p< 0.0001 and p=0.0052, respectively). 
izmerjene s povprečno odstotno spremembo indeksa izraženosti psoriaze nohtov (Nail Psoriasis Severity Index (NAPSI)) od izhodišča (p< 0,0001 oziroma p=0,0052).
• nausea 
• bruhanje,
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja občasni izpuščaj urtikarija neznana angioedem
Otezla contains lactose 
Zdravilo Otezla vsebuje laktozo
Diarrhoea* Nausea* 
Bolezni prebavil zelo pogosti driska*
• diarrhoea 
• driska,
Dyspepsia 
Odmerjanje
General disorders and administration site conditions 
Splošne težave in spremembe na mestu aplikacije pogosti utrujenost
Protect other people 
Zaščitite druge ljudi
These reactions have often been transitory. 
Ti učinki so bili pogosto prehodni.
• if they drink alcohol 
• ki pijejo alkohol,
Then continue your treatment as before. 
Nadaljujte z zdravljenjem tako, kot prej.
Assessed using a non-inferiority margin of 10%. 
Ocenjeno z uporabo meje neinferiornosti 10 %.
This helps maintain the number of CD4 cells in your blood. 
To pomaga ohranjati število celic CD4 v vaši krvi.
→ Tell your doctor immediately. 
→ Takoj obvestite svojega zdravnika.
Individual components have been investigated in adolescents (12 to 17 years). 
Posamezne komponente so raziskovali pri mladostnikih (starih od 12 do 17 let).
→ If you think this applies to you, tell your doctor. 
→ Če menite, da to velja za vas, povejte svojemu zdravniku.
The clinical relevance of these findings is unknown. 
Klinična pomembnost teh ugotovitev ni znana.
Use in adolescents 
Uporaba pri mladostnikih
This medicine is not for use in children under 12 years of age, because it has not been studied in these patients. 
Otroci To zdravilo ni namenjeno otrokom, mlajšim od 12 let, ker njegova uporaba pri teh bolnikih ni bila raziskana.
Your doctor will monitor the effectiveness of your treatment. 
Zdravnik bo spremljal učinkovitost vašega zdravljenja.
• weakness beginning in the hands and feet and moving up towards the trunk of the body. 
• oslabelost, ki se začne v rokah in stopalih in se širi navzgor proti trupu
If you miss a dose, take it as soon as you remember. 
Če ste pozabili na odmerek, ga vzemite, kakor hitro se spomnite.
Symptoms may include: 
Simptomi lahko vključujejo:
You need to be aware of the extra risks: 
Zavedati se morate, da je tveganje večje:
• if you have moderate or severe liver disease 
• če imate zmerno ali hudo bolezen jeter
Tell your doctor if you are taking any of the medicines in the following list: 
Povejte svojemu zdravniku, če jemljete katero od zdravil z naslednjega seznama:
A similar effect was not seen in rats even at very high systemic exposure. 
Pri podganah podobnega učinka niso opazili, tudi pri zelo visoki sistemski izpostavljenosti ne.
Effect of human serum 
Vpliv humanega seruma
Gender Male Female Race White African-American/African Heritage/Other Age (years) 
Spol moški ženske Rasa belci afroameričani/afriško poreklo/drugo Starost (leta)
N = Number of subjects in each treatment group 
N = število preiskovancev v vsaki terapevtski skupini.
• The recommended dose of Dovato is one tablet once a day. 
• Priporočeni odmerek zdravila Dovato je ena tableta enkrat na dan.
Do not take Dovato: 
Ne jemljite zdravila Dovato:
If you are pregnant, think you may be pregnant, or if you are planning to have a baby: 
Če ste noseči, mislite, da bi lahko bili noseči ali načrtujete zanositev:
Such infections may have been “silent” and not detected by the weak immune system before treatment was started. 
Takšne okužbe lahko potekajo »tiho« in jih oslabljeni imunski sistem pred začetkom zdravljenja ne zazna.
The absolute bioavailability of oral lamivudine in adults is approximately 80-85%. 
Absolutna biološka razpoložljivost lamivudina po peroralnem dajanju pri odraslih znaša približno 80 - 85 %.
Like all medicines, this medicine can cause side effects, although not everybody gets them, so it is very important to talk to your doctor about any changes in your health. 
Kot vsa zdravila, ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih, zato je zelo pomembno, da se z zdravnikom pogovorite o vseh spremembah, ki jih opazite glede vašega zdravja.
Component of a multipack, can't be sold separately. 
Sestavni del pakiranja po več enot, ki se ne prodaja ločeno.
CD4 cells are a type of white blood cells that are important in helping your body to fight infection. 
Celice CD4 so vrsta belih krvnih celic, ki so v telesu pomembne za boj proti okužbi.
Reference should be made to treatment guidelines. 
Upoštevati je treba smernice za zdravljenje.
Pooled analysis also stratified by study. 
Združena analiza je bila stratificirana tudi glede na študijo.
Pharmacokinetic parameters are comparable to those reported in adults. 
Farmakokinetični parametri so primerljivi s tistimi pri odraslih.
If possible, show them the Dovato pack. 
Po možnosti jima pokažite ovojnino zdravila Dovato.
Do not stop taking Dovato without consulting your doctor, as this may harm you and your unborn child. 
Brez posvetovanja z zdravnikom ne prenehajte jemati zdravila Dovato, ker to lahko škoduje vam in vašemu nerojenemu otroku.
• abnormal dreams 
• nenormalne sanje
The table should not be considered exhaustive but is representative of the classes studied. 
Preglednice ne gre jemati, kot da je dokončna, je pa reprezentativna za preučevane skupine.
Dovato should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus. 
Zdravilo Dovato se lahko uporablja v nosečnosti samo, če pričakovana korist upravičuje morebitno tveganje za plod.
Frequencies are defined as 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), not known (cannot be estimated from the available data). 
Pogostnosti so opredeljene kot: 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), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Not everyone responds to treatment with Dovato in the same way. 
Na zdravljenje z zdravilom Dovato se vsi ne odzivajo enako.
Transmission of HIV 
Prenašanje virusa HIV
Interaction geometric mean change (%) 
Geometrijsko povprečje spremembe (%)
Double blind therapy will continue up to week 96, followed by open label therapy up to week 148. 
Dvojno slepo zdravljenje se bo nadaljevalo do 96. tedna, sledilo bo odprto zdravljenje do 148. tedna.
→ Don't drive or operate machinery unless you are sure you're not affected. 
→ Ne vozite ali upravljajte strojev, če niste prepričani, da zdravilo na vas tako ne vpliva.
Swallow the tablet with some liquid. 
Tableto pogoltnite z nekaj tekočine.
If you get any symptoms of infection or if you notice any of the symptoms above: 
Če se pri vas pojavijo simptomi okužbe in vnetja ali če opazite katerega od zgoraj naštetih simptomov:
Your doctor may decide to adjust your dose or that you need extra check ups. 
Zdravnik se lahko odloči, da vam prilagodi odmerek ali da potrebujete dodatne kontrolne preglede.
What you need to know before you take Dovato 3. 
Kaj morate vedeti, preden boste vzeli zdravilo Dovato 3.
• if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, don't stop Dovato without your doctor's advice, as your hepatitis may come back) 
• če ste kdaj imeli bolezen jeter, vključno s hepatitisom B ali C (če imate okužbo s hepatitisom B, ne prenehajte jemati zdravila Dovato brez posveta z vašim zdravnikom, saj se lahko hepatitis ponovi)