natgillin/translations-raw huggingface dataset:
†Other clades included: Complex (43), F1 (32), A1 (18), BF (14), all others <10. 
†Drugi podtipi so vključevali: kompleks (43), F1 (32), A1 (18), BF (14), vse druge < 10.
Children 6 to less than 12 years of age 
Otroci v starosti od 6 do manj kot 12 let
• suicide attempt* 
• poskus samomora*
As a result of that, it also increases the CD4 cell count in your blood. 
Posledica tega je, da se poveča tudi število celic CD4 v krvi.
* particularly in patients who have had depression or mental health problems before 
*zlasti pri bolnikih, ki so že imeli probleme z depresijo ali duševnim zdravjem
It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV. 
Priporočljivo je, da ženske, okužene z virusom HIV, pod nobenim pogojem ne dojijo svojih otrok, da bi se izognile prenosu virusa HIV.
Not everyone responds to treatment with Tivicay in the same way. 
Na zdravljenje z zdravilom Tivicay se vsi ne odzivajo enako.
When Tivicay is taken twice a day, your doctor may advise you to take with food. 
Kadar pa se zdravilo Tivicay jemlje dvakrat na dan, vam bo zdravnik morda svetoval, da ga vzemite med jedjo.
The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection. 
Simptomi avtoimunih bolezni se lahko pojavijo mnogo mesecev po tem, ko ste začeli jemati zdravila za zdravljenje okužbe z virusom HIV.
Food increased the extent and slowed the rate of absorption of dolutegravir. 
Hrana poveča obseg in upočasni hitrost absorpcije dolutegravirja.
‡ Adjusted mean treatment difference was statistically significant (p<0.001) 
‡ Prilagojena srednja razlika v zdravljenju je bila statistično značilna (p < 0,001)
• if you are allergic to dolutegravir or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na dolutegravir ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing 
• oteklino, včasih obraza ali ust (angioedem), ki povzroča oteženo dihanje
These changes are not considered to be clinically relevant since they do not reflect a change in glomerular filtration rate. 
Te spremembe niso klinično pomembne, saj ne odražajo spremembe v hitrosti glomerulne filtracije.
→ If you think any of these apply to you, tell your doctor. 
→ Če menite, da kar koli od navedenega velja za vas, povejte svojemu zdravniku.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available. 
Nadaljnja obravnava mora biti v skladu s kliničnimi indikacijami oziroma priporočili nacionalnega centra za zastrupitve, če so na voljo.
OSS: combined genotypic and phenotypic resistance (Monogram Biosciences Net Assessment) 
OSS: skupaj genotipska in fenotipska odpornost (ocena po Monogram Biosciences Net)
• suicidal thoughts* 
• samomorilne misli*
Approximately one third of the patients were infected with an HIV non-B subtype; these characteristics were similar between treatment groups. 
Približno ena tretjina bolnikov je bila okužena z ne-B podtipom HIV; te značilnosti so bile primerljive med zdravljenimi skupinami.
• rifampicin, to treat tuberculosis (TB) and other bacterial infections 
• rifampicin, za zdravljenje tuberkuloze (TBC) in drugih bakterijskih okužb
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). 
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).
Gender Male Female Race White African-America/African Heritage/Other Age (years) 
Spol moški ženske Rasa belci afroameričani/afriški staroselci/ostali Starost (leta)
Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in Table 2. 
Ugotovljene in hipotetične interakcije z izbranimi protiretrovirusnimi in ne-protiretrovirusnimi zdravili so navedene v Preglednici 2.
Tivicay does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. 
Zdravilo Tivicay ne ozdravi okužbe z virusom HIV, ampak zmanjša količino virusa v telesu in jo vzdržuje na nizki ravni.
Tivicay can be taken with or without food. 
Zdravilo Tivicay se lahko vzame s hrano ali brez nje.
*particularly in patients with a pre-existing history of depression or psychiatric illness. 
*zlasti pri bolnikih z že obstoječo anamnezo depresije ali psihiatrične bolezni
Total blood and plasma drug-related radioactivity concentration ratios averaged between 0.441 to 0.535, indicating minimal association of radioactivity with blood cellular components. 
Celotno razmerje koncentracije z zdravilom povezane radioaktivnosti v krvi in plazmi je povprečno med 0,441 in 0,535; to kaže na minimalno povezanost radioaktivnosti s celičnimi elementi krvi.
HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). 
Okužba s HIV se prenaša s spolnim stikom z nekom, ki ima okužbo, ali z okuženo krvjo (na primer s souporabo injekcijskih igel).
Tivicay can also affect how some other medicines work. 
Zdravilo Tivicay lahko vpliva tudi na delovanje drugih zdravil.
Raltegravir/elvitegravir was part of the current failing regimen in 98/183 patients (part of prior failing therapies in the others). 
Raltegravir/elvitegravir je bil del trenutno neuspešne sheme pri 98/183 bolnikih (del predhodnih neuspešnih terapij pri ostalih).
Adolescents aged 12 and above 
Mladostniki, stari 12 let in več
The R263K mutation was also selected in vitro (see above). 
Mutacija R263K je bila izbrana tudi in vitro (glejte zgoraj).
If you are pregnant, if you become pregnant, or if you are planning to have a baby: 
Nosečnost Če ste noseči, če zanosite ali načrtujete zanositev:
Week 24 (N=161) 
24. teden (N=161)
• difficulty breathing In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders). 
• oteženo dihanje V redkih primerih, ko se imunski sistem okrepi, lahko ta napade tudi zdrava telesna tkiva (avtoimune bolezni).
Tivicay is always used in combination with other anti-retroviral medicines (combination therapy). 
Zdravilo Tivicay se vedno uporablja v kombinaciji z drugimi protiretrovirusnimi zdravili (kombinirano zdravljenje).
Based on data from other CYP3A4 inhibitors, a marked increase is not expected. 
Na podlagi podatkov o drugih zaviralcih CYP3A4 ni pričakovati opaznega povišanja.
Dolutegravir ↔ (Not studied) 
nelfinavir dolutegravir ↔ (ni raziskano)
(cps/mL) 
(kopij/ml)
• increase in the level of enzymes produced in the muscles (creatine phosphokinase). 
• zvišane vrednosti encimov, ki nastajajo v mišicah (kreatin fosfokinaza)
Limited experience of single higher doses (up to 250 mg in healthy subjects) revealed no specific symptoms or signs, apart from those listed as adverse reactions. 
Omejene izkušnje z enkratnim višjim odmerkom (do 250 mg pri zdravih osebah) niso razkrile nobenih specifičnih simptomov ali znakov, razen tistih, naštetih med neželenimi učinki.
Using strain NL432, mutations E92Q (FC 3) and G193E (also FC 3) were selected. 
NL432 so bile izbrane mutacije E92Q (tudi FC 3) in G193E (FC 3).
Co-treatment with atazanavir increases the exposure of dolutegravir markedly, and should not be used in combination with this high dose, since safety with the resulting dolutegravir exposure has not been established. 
Sočasno zdravljenje z atazanavirjem izrazito poveča izpostavljenost dolutegravirju in se ga v kombinaciji s tem visokim odmerkom ne sme uporabljati, ker varnost posledične izpostavljenosti dolutegravirju ni ugotovljena.
Do not use this medicine after the expiry date which is stated after EXP on the carton and bottle. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vsebniku poleg oznake »EXP«.
Week 48 (N=160) 
48. teden (N=160)
Do not discontinue Tivicay without consulting your doctor, as this may harm you and your unborn child. 
Brez posvetovanja z zdravnikom ne prenehajte jemati zdravilo Tivicay, ker to lahko škoduje vam in vašemu nerojenemu otroku.
Creatinine increases were comparable by various background regimens. 
Zvišane vrednosti kreatinina so bile pri različnih osnovnih shemah primerljive.
There is no evidence that elderly patients require a different dose than younger adult patients (see section 5.2). 
Ni dokazov, da bi starejši bolniki potrebovali drugačen odmerek kot mlajši odrasli bolniki (glejte poglavje 5.2).
• etravirine, efavirenz, fosamprenavir/ritonavir, nevirapine or tipranavir/ritonavir, to treat HIV infection 
• etravirin, efavirenz, fosamprenavir/ritonavir, nevirapin ali tipranavir/ritonavir, za zdravljenje okužb z virusom HIV
Because gastrointestinal (GI) intolerance is considered to be due to local active substance administration, mg/kg or mg/m2 metrics are appropriate determinates of safety cover for this toxicity. 
Gastrointestinalna intoleranca (GI) velja za posledico lokalne uporabe učinkovine, zato sta enoti mg/kg ali mg/m2 ustrezni determinanti varnostnega kritja za ta toksični učinek.
Dolutegravir is present in cerebrospinal fluid (CSF). 
Dolutegravir je prisoten v cerebrospinalni tekočini (CSF - cerebrospinal fluid).
Lamivudine and dolutegravir 
Lamivudin in dolutegravir
Over the preweaning treatment period, mean body weight gain was decreased in this group and the decrease persisted throughout the entire study for females during the postweaning period. 
Med obdobjem uporabe zdravila pred odstavitvijo se je povprečno povečanje telesne mase v tej skupini zmanjšalo in zmanjšanje se je ohranilo med celotno študijo pri samicah med obdobjem po odstavitvi.
A clinically relevant phenotypic cut-off value (FC vs wild type virus) has not been determined; genotypic resistance was a better predictor for outcome. 
Klinično pomembna fenotipska izhodiščna vrednost (FC proti virusu divjega tipa) ni bila določena; boljši napovedni dejavnik izida je bila genotipska odpornost.
At week 96, results were consistent with those seen at week 48. 
Rezultati po 96 tednih so se skladali z rezultati po 48 tednih.
• if you are taking another medicine called dofetilide (to treat heart conditions). 
• če jemljete drugo zdravilo, ki se imenuje dofetilid (za zdravljenje bolezni srca).
Your doctor will decide on the correct dose of Tivicay for you. 
Zdravnik bo presodil o pravilnem odmerku zdravila Tivicay za vas.
Tivicay can be taken with or without food (see section 5.2). 
Zdravilo Tivicay se lahko jemlje s hrano ali brez nje (glejte poglavje 5.2).
Your doctor may decide to adjust your dose or that you need extra check ups. 
da vam prilagodi odmerek ali da potrebujete dodatne kontrolne preglede.
The effect of prolonged daily treatment with high doses of dolutegravir has been evaluated in repeat oral dose toxicity studies in rats (up to 26 weeks) and in monkeys (up to 38 weeks). 
Vpliv dolgotrajnega vsakodnevnega zdravljenja z velikimi odmerki dolutegravirja so ocenili v študijah toksičnosti ponavljajočih se peroralnih odmerkov pri podganah (do 26 tednov) in opicah (do 38 tednov).
TIVICAY ~1 mg/kg Once Daily + OBR 
TIVICAY ~1 mg/kg enkrat na dan + OBR
**see below under Description of selected adverse reactions. 
** glejte Opis izbranih neželenih učinkov spodaj Opis izbranih neželenih učinkov
Any inflammatory symptoms should be evaluated and treatment instituted when necessary. 
Vsak simptom vnetja, ki se pojavi, je treba oceniti in uvesti zdravljenje, kadar je potrebno.
Some people taking medicines for HIV infection develop other conditions, which can be serious. 
Pri nekaterih ljudeh, ki jemljejo zdravila za zdravljenje okužbe s HIV, se pojavijo druge zdravstvene težave, ki so lahko resne.
- This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'. 
- To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Tivicay. 
Zdravnik se lahko odloči, da pri vas opravi teste za pregled jeter, ledvic ali krvi in vam naroči, da prenehate z jemanjem zdravila Tivicay.
Bioequivalence has not been unequivocally shown for 1x50 mg tablet compared to 5x10 mg tablets. 
Bioekvivalenca ni bila nedvoumno dokazana za 1x50 mg tablete v primerjavi z 5x10 mg tabletami.
The most commonly seen treatment emergent adverse reactions were nausea (13%), diarrhoea (18%) and headache (13%). 
Najpogosteje opaženi neželeni učinki, povezani z zdravljenjem, so bili: navzea (13%), driska (18%) in glavobol (13%).
• increase in the level of liver enzymes 
• zvišane vrednosti jetrnih encimov
The European Medicines Agency has deferred the obligation to submit the results of studies with Tivicay in paediatric patients aged 4 weeks to below 6 years with HIV infection (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Tivicay pri pediatrični populaciji bolnikov, starih od 4 tednov do manj kot 6 let, okuženih z virusom HIV (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
What you need to know before you take Tivicay 3. 
Kaj morate vedeti, preden boste vzeli zdravilo Tivicay 3.
Oral contraceptives Ethinyl estradiol (EE) and Norelgestromin (NGMN) 
Peroralni kontraceptivi etinilestradiol (EE) in norelgestromin (NGMN)
• abnormal dreams 
• omotica • nenormalne sanje
Resistance in vitro 
Odpornost in vitro
In addition, no antagonistic effects were seen for dolutegravir and adefovir, and ribavirin had no apparent effect on dolutegravir activity. 
Poleg tega ni bilo opaziti antagonističnih učinkov za dolutegravir in adefovir, ribavirin ni imel opaznega vpliva na delovanje dolutegravirja.
Do not give this medicine to children under 6 years of age, weighing less than 15 kg or with HIV infection that is resistant to other medicines similar to Tivicay. 
Ne dajajte tega zdravila otrokom, mlajšim od 6 let, ki tehtajo manj kot 15 kg ali so okuženi z virusom HIV, ki je odporen na druga zdravila, podobna zdravilu Tivicay.
Taking Tivicay at the time of becoming pregnant or during the first twelve weeks of pregnancy, may increase the risk of a type of birth defect, called neural tube defect, such as spina bifida (malformed spinal cord). 
Jemanje zdravila Tivicay ob zanositvi ali v prvih dvanajstih tednih nosečnosti lahko poveča tveganje za prirojeno napako, imenovano okvara nevralne cevi, kot je spina bifida (nepravilno oblikovana hrbtenjača).
This regimen is only suitable for the treatment of HIV-1 infection where there is no known or suspected resistance to the integrase inhibitor class, or to lamivudine. 
Ta shema je primerna le za zdravljenje okužbe s HIV-1, kadar ni znane ali domnevne odpornosti na skupino zaviralcev integraze ali na lamivudin.
The study enrolled 183 patients, 133 with INI-resistance at Screening and 50 with only historical evidence of resistance (and not at Screening). 
V študijo je bilo vključenih 183 bolnikov, 133 z odpornostjo na INI ob presejanju in 50 z zgolj anamnestičnimi podatki o odpornosti (brez odpornosti ob presejanju).
Table 9 Virologic (Snapshot algorithm) and Immunologic Activity of Treatment for Subjects 6 Years and Older in P1093 
Preglednica 9: Virološka (»snapshot« algoritem) in imunološka aktivnost zdravljenja pri preiskovancih, starih 6 let ali več, v študiji P1093
There are limited data available on the use of dolutegravir in patients aged 65 years and over. 
Starostniki Na voljo so omejeni podatki o uporabi dolutegravirja pri bolnikih starih 65 let ali več.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement. 
Bolnikom je treba povedati, da naj se posvetujejo s svojim zdravnikom, če se jim pojavijo bolečine v sklepih, okorelost sklepov ali težave pri gibanju.
Table 7 Virologic response (day 8) after 7 days of functional monotherapy, in patients with RAL/EVG as part of current failing regimen, VIKING 3 
Preglednica 7: Virološki odziv (8. dan) po 7 dneh funkcionalne monoterapije pri bolnikih z RAL/EVG kot delom trenutne neuspešne sheme, VIKING-3
What Tivicay is and what it is used for 2. 
Kaj je zdravilo Tivicay in za kaj ga uporabljamo 2.
People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). 
Osebe z napredovalo okužbo s HIV (AIDS) imajo oslabljen imunski sistem in večjo verjetnost, da se pri njih razvije hujša okužba (oportunistične okužbe).
There were no new target organs identified in juveniles compared to adults. 
Pri mladih živalih v primerjavi z odraslimi niso ugotovili novih tarčnih organov.
It is not known whether the ingredients of Tivicay can pass into your breast milk. 
Ni znano ali sestavine zdravila Tivicay lahko prehajajo v materino mleko.
Week 48 outcomes (including outcomes by key baseline covariates) for SAILING are shown in Table 6. 
Rezultati po 48 tednih (vključno z rezultati po ključnih osnovnih spremenljivkah) študije SAILING so prikazani v Preglednici 6.
Cohort I (12 to <18 years) (n=23) 
Kohorta I (od 12 do < 18 let) (n = 23)
Pharmacotherapeutic group: Antivirals for systemic use, other antivirals, ATC code: J05AX12 
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, druga zdravila za zdravljenje virusnih infekcij, oznaka ATC: J05AX12
Treatment-emergent mutations observed were consistent with those observed in the VIKING-3 study. 
Opažene mutacije, ki so se pojavile med zdravljenjem, so bile skladne z mutacijami, opaženimi v študiji VIKING-3.
In further selection experiments using clinical isolates of subtype B, mutation R263K was seen in all five isolates (after 20 weeks and onwards). 
Pri nadaljnjih preskušanjih selekcije z uporabo kliničnih izolatov podtipa B, so pri vseh petih izolatih opazili mutacijo R263K (po 20 tednih in naprej).
Once the bottle has been opened keep the desiccant in the bottle, do not remove it. 
Potem, ko vsebnik odprete, pustite sušilno sredstvo v njem in ga ne odstranjujte.
→ Talk to your doctor about the risks and benefits of taking Tivicay. 
→ Posvetujte se z zdravnikom o tveganjih in koristih jemanja zdravila Tivicay.
These increases may be clinically relevant in the presence of certain integrase class resistance. 
Ta povečanja so lahko klinično pomembna pri odpornosti na določena zdravila iz skupine zaviralcev integraze.
Treatment-emergent mutations or mixtures of mutations observed were L74I (n=1), N155H (n=2). 
Opažene med zdravljenjem nastale mutacije ali mešanice mutacij so bile L74I (n = 1), N155H (n = 2).
In subtype C (n=2) and A/G (n=2) isolates the integrase substitution R263K was selected in one isolate, and G118R in two isolates. 
Pri izolatih podtipa C (n=2) in A/G (n=2) je bila pri enem izolatu izbrana substitucija integraze R263K, pri dveh pa G118R.
There are no data on the effects of dolutegravir on human male or female fertility. 
Ni podatkov o vplivu dolutegravirja na moško ali žensko plodnost pri ljudeh.
Serial passage is used to study resistance evolution in vitro. 
Za preučevanje razvoja odpornosti in vitro se uporablja zaporedni prehod.
Tivicay should not be used in children and adolescents with HIV infection that is resistant to other medicines similar to Tivicay. 
Zdravilo Tivicay se ne sme uporabljati pri otrocih in mladostnikih z okužbo HIV, ki je odporna na druga zdravila, podobna zdravilu Tivicay.
It is unknown if all or part of this is due to unabsorbed active substance or biliary excretion of the glucuronidate conjugate, which can be further degraded to form the parent compound in the gut lumen. 
Ni znano, ali je vsa ta količina ali pa samo njen del neabsorbirana učinkovina ali pa je posledica biliarnega izločanja glukuronidnega konjugata, ki se v črevesni svetlini razgradi, tako da nastane izhodna spojina.
With 50 mg twice daily, the exposure over 24 hours was approximately doubled compared to 50 mg once daily. 
Pri 50 mg dvakrat na dan se je izpostavljenost v 24 urah v primerjavi s 50 mg enkrat na dan približno podvojila.
The effect by the Q148-mutations (H/R/K) was also verified in passage experiments with site directed mutants. 
Vpliv mutacij Q148 (H/R/K) je bil potrjen tudi v poskusih prehajanja s točkovnimi mutanti.
Co-administration with dofetilide (see section 4.5). 
Sočasna uporaba z dofetilidom (glejte poglavje 4.5).
This is supported by 96 week data from an open-label, randomized and activecontrolled study FLAMINGO (ING114915) and additional data from the open-label phase of SINGLE to 144 weeks. 
To potrjujejo 96-tedenski podatki odprte, randomizirane, z učinkovino kontrolirane študije FLAMINGO (ING114915) in dodatni podatki odprte faze študije SINGLE do 144. tedna.
For children aged between 6 and 12 years your doctor will decide on the correct dose of Tivicay, depending on the weight of your child. 
Za otroke, stare od 6 do 12 let, bo ustrezen odmerek zdravila Tivicay določil zdravnik glede na otrokovo telesno maso.
Response was associated with baseline INI mutation pathway, as shown in Table 7. 
Odziv je bil povezan z osnovnim potekom mutacije INI, kot je prikazano v preglednici 7.
If you could get pregnant while receiving Tivicay, you need to use a reliable method of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection), to prevent pregnancy. 
Če bi lahko med jemanjem zdravila Tivicay zanosili, morate za preprečitev nosečnosti poleg drugih načinov kontracepcije, vključno s peroralnimi (kontracepcijske tablete) ali drugimi hormonskimi kontracepcijskimi sredstvi (na primer vsadki, injekcije), uporabljati zanesljiv način pregradne kontracepcije (na primer kondom).
Resistance in vivo 
Odpornost in vivo
Preliminary data from a surveillance study has suggested an increased incidence of neural tube defects (0.9%) in mothers exposed to dolutegravir at the time of conception compared with mothers exposed to nondolutegravir containing regimens (0.1%). 
Predhodni podatki iz opazovalne študije so pokazali večjo incidenco okvar nevralne cevi (0,9 %) pri materah, ki so bile ob spočetju izpostavljene dolutegravirju, v primerjavi z materami, ki so bile izpostavljene režimom, ki niso vsebovali dolutegravirja (0,1 %).
1 Historical or phenotypic evidence of INI resistance only. 
1 Samo retrospektivni ali fenotipski podatki o odpornost na INI
The effect of severe hepatic impairment on the pharmacokinetics of Tivicay has not been studied. 
Vpliva hude okvare jeter na farmakokinetiko zdravila Tivicay niso raziskali.
The E92Q mutation has been selected in patients with pre-existing raltegravir resistance who were then treated with dolutegravir (listed as a secondary mutation for dolutegravir). 
Mutacija E92Q je bila izbrana pri bolnikih, ki so že bili odporni na raltegravir in so bili nato zdravljeni z dolutegravirjem (navedena kot sekundarna mutacija za dolutegravir).
In contrast, starting with mutants harbouring mutation Q148H (FC 1), a variety of secondary mutations were seen with a consequent increase of FC to values >10. 
Nasprotno pa so pri začetku z mutanti, ki so vključevali mutacijo Q148H (FC 1), opazili vrsto sekundarnih mutacij s posledičnim porastom vrednosti FC >10.
Within-subject variability (CVw%) is lower than between-subject variability. 
Intraindividualna variabilnost (CVw%) je manjša kot interindividualna variabilnost.
Based on limited available data in children and adolescents (6 to less than 18 years of age and weighing at least 15 kg), there were no additional types of adverse reactions beyond those observed in the adult population. 
Na podlagi omejenih razpoložljivih podatkov pri otrocih in mladostnikih (starih od 6 do manj kot 18 let, s telesno maso vsaj 15 kg) ni bilo nobenih dodatnih neželenih učinkov poleg tistih, ki so jih zabeležili pri odraslih.
20 mg once daily (Taken as two 10 mg tablets) 
20 mg enkrat na dan (Uporabljen kot dve 10 mg tableti)