natgillin/translations-raw huggingface dataset:
Therefore, it is reasonable to expect that cardiac lopinavir levels would not be significantly higher than plasma levels. 
Stoga ima razloga očekivati da razine lopinavira u srcu neće biti znatno više od onih u plazmi.
Hypersensitivity to the active substances or to any of the excipients. 
Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari.
Use in children 
Primjena u djece
Mean (%CV) Steady-State Pharmacokinetic Parameters of Lopinavir in HIV-Infected Pregnant Women 
Srednja vrijednost (%CV) farmakokinetičkih parametara lopinavira u stanju dinamičke ravnoteže u trudnica s HIV infekcijom
BSA (m2) = √ (Height (cm) X Weight (kg) / 3600) 
PT (m2) = √ (visina (cm) X težina (kg) / 3600)
Tissue distribution studies conducted in the rat did not suggest significant cardiac retention of the active substance; 72-hour AUC in heart was approximately 50% of measured plasma AUC. 
Ispitivanja distribucije u tkivima, provedena u štakora, nisu uputila na znatnije zadržavanje lijeka u srcu; AUC u srcu nakon 72 sata bio je otprilike 50 % od AUC-a izmjerenog u plazmi.
Do not shake the bottle - this is because air bubbles can form which will affect how well you can measure the dose. 
Nemojte tresti bocu jer tako mogu nastati mjehurići zraka koji će otežati precizno odmjeravanje doze.
It is unknown whether the combination of Kaletra causes a similar increase in trazodone exposure. 
Nije poznato uzrokuje li Kaletra sličan porast izloženosti trazodonu.
EU/1/01/172/005 - multipack: 120 (3 packs of 40) film-coated tablets EU/1/01/172/008 - carton of 120 film-coated tablets 
EU/1/01/172/005 - višestruko pakiranje: 120 (3 pakiranja od 40) filmom obloženih tableta EU/1/01/172/008 - kutija sa 120 filmom obloženih tableta
• Taking Kaletra as recommended should give you the best chance of delaying the development of resistance to the product. 
• Uzimanje lijeka Kaletra sukladno preporukama daje najveće šanse za odgađanjem razvoja otpornosti na lijek.
Kaletra contains 42% v/v alcohol. 
Kaletra sadrži 42% V/V alkohola.
Lamotrigine and Valproate 
Lamotrigin i valproat
Like all medicines, Kaletra can cause side effects, although not everybody gets them. 
Kao i svi lijekovi, Kaletra može izazvati nuspojave, iako se one neće javiti kod svakoga.
Other medicines and Kaletra); 
Drugi lijekovi i Kaletra);
These medicinal products include: 
Ti lijekovi uključuju:
− Keep this leaflet. 
- Sačuvajte ovu uputu.
• Keep this medicine out of the sight and reach of children. 
• Lijek čuvajte izvan pogleda i dohvata djece.
Events noted as having frequency “Not known” were identified via post-marketing surveillance. 
“Nepoznato” su zabilježeni u postmarketinškom praćenju.
Ergot alkaloids 
Ergot alkaloidi
• Once-daily administration of lopinavir/ritonavir is not recommended for pregnant women due to the lack of pharmacokinetic and clinical data. 
• Kod trudnica se primjena lopinavira/ritonavira jednom dnevno ne preporučuje zbog nedostatka farmakokinetičkih i kliničkih podataka.
Alcohol and propylene glycol are potentially harmful for those suffering from liver disease, kidney disease, alcoholism, epilepsy, brain injury or disease, as well as for pregnant women and children. 
Alkohol i propilenglikol su potencijalno štetni za osobe s bolestima jetre, bolestima bubrega, alkoholizmom, epilepsijom, ozljedama i bolestima mozga, kao i za trudnice i djecu.
Lack of resistance to lopinavir was confirmed by phenotypic analysis. 
Nepostojanje rezistencije na lopinavir je potvrđeno fenotipskom analizom.
• Muscle pain, tenderness or weakness, particularly in combination with these medicines. 
• Mišićnu bol, osjetljivost ili slabost, osobito prilikom uzimanja ovih lijekova.
For volumes greater than 2 ml. 
Za volumene veće od 2 ml.
Tell your doctor if you or your child have/had 
Kažite svome liječniku ako ste Vi ili Vaše dijete imali/imate
Lopinavir/ritonavir has been shown to cause modest asymptomatic prolongation of the PR interval in some healthy adult subjects. 
Pokazalo se da lopinavir/ritonavir uzrokuje umjerenu asimptomatsku prolongaciju PR intervala u nekih zdravih odraslih osoba.
Healthcare professionals should be aware that Kaletra oral solution is highly concentrated and contains 42.4% alcohol (v/v) and 15.3% propylene glycol (w/v). 
Zdravstveni radnici moraju biti svjesni da je Kaletra oralna otopina visoko koncentrirana i da sadrži 42,4% alkohola (V/V) i 15,3% propilenglikola (m/V).
At steady state, lopinavir is approximately 98 − 99% bound to serum proteins. 
U stanju dinamičke ravnoteže, oko 98 - 99% lopinavira vezano je na serumske proteine.
Uncommon Weight increased, increased appetite 
Manje često Povećanje tjelesne težine, povećanje apetita
*Body surface area can be calculated with the following equation 
*Površina tijela može se izračunati sljedećom formulom
See further the detailed description of the clinical studies. 
Vidjeti detaljan opis kliničkih ispitivanja u nastavku.
• decreased ability of the body to handle sugar including diabetes mellitus, weight loss; 
• smanjena sposobnost tijela da regulira šećer uključujući šećernu bolest (diabetes mellitus), gubitak tjelesne težine;
• yellowing of the skin or whites of eyes (jaundice); 
• žutilo kože ili bjeloočnica (žutica);
Fournier Laboratories Ireland Limited, Carrigtwohill Business Park, Anngrove, Carrigtwohill, Co. Cork, Ireland 
Fournier Laboratories Ireland Limited, Carrigtwohill Business Park, Anngrove, Carrigtwohill, Co.
60 ml oral solution 
60 ml oralne otopine
Do not drive a car or operate machinery if you experience any side effects (e.g. nausea) that impact your ability to do so safely. 
Ne vozite i ne upravljate strojem ukoliko primijetite bilo koju nuspojavu (npr. mučninu) koja može utjecati na Vašu sposobnost sigurne vožnje vozila ili upravljanje strojem.
Kaletra pharmacokinetics have not been studied in older people. 
Farmakokinetika lijeka Kaletra u starijih ljudi nije ispitana.
Anxiety Uncommon Abnormal dreams, libido decreased 
Neuobičajeni snovi, smanjeni libido
There is no specific antidote for overdose with Kaletra. 
Nema specifičnog antidota za predoziranje lijekom Kaletra.
Since these patients had not previously been exposed to either Kaletra or efavirenz, part of the response may be attributed to the antiviral activity of efavirenz, particularly in patients harbouring highly lopinavir resistant virus. 
Budući da bolesnici dotad nisu primali ni lijek Kaletra ni efavirenz, odgovor se djelomice može pripisati i protuvirusnoj aktivnosti efavirenza, osobito u bolesnika zaraženih virusom izrazito rezistentnim na lopinavir.
Within this panel, the following mutations in HIV protease were associated with reduced in vitro susceptibility to lopinavir: L10F/I/R/V, K20M/R, L24I, M46I/L, F53L, I54L/T/V, L63P, A71I/L/T/V, V82A/F/T, I84V and L90M. 
U tom rasponu virusnih izolata sljedeće su mutacije HIV proteaze bile povezane sa smanjenom osjetljivošću na lopinavir in vitro: L10F/I/R/V, K20M/R, L24I, M46I/L, F53L, I54L/T/V, L63P, A71I/L/T/V, V82A/F/T, I84V i L90M.
See section 4.4 and section 4.5 for co-administration of sildenafil in patients with erectile dysfunction. 
Vidjeti dijelove 4.4 i 4.5 za istodobnu primjenu sildenafila kod bolesnika s erektilnom disfunkcijom.
BSA (m2) = √ (Height (cm) X Weight (kg) / 3600) It is recommended that Kaletra not be administered in combination with efavirenz or nevirapine in patients less than 6 months of age. 
PT (m2) = √ (visina (cm) X težina (kg) / 3600) Preporučuje se da se Kaletra ne primjenjuje u kombinaciji s efavirenzom ili nevirapinom u bolesnika mlađih od 6 mjeseci.
Outcomes at Week 24: Study P1060 Cohort I 
Rezultati u 24. tjednu: studija P1060 Kohorta
In vitro experiments with human hepatic microsomes indicate that lopinavir primarily undergoes oxidative metabolism. 
In vitro pokusi s ljudskim mikrosomima iz jetre pokazuju da se lopinavir metabolizira prvenstveno oksidacijskim metabolizmom.
• sedatives (e.g. midazolam administered by injection); 
• sedativi (npr. midazolam primijenjen putem injekcije);
• anti-tuberculosis medicine (bedaquiline, delamanid); 
• lijek za liječenje tuberkuloze (bedakilin, delamanid);
Kaletra contains polyoxyl 40 hydrogenated castor oil. 
Kaletra sadrži polioksil 40 hidrogenirano ricinusovo ulje.
High doses of ketoconazole and itraconazole (> 200 mg/day) are not recommended. 
Ne preporučuju se velike doze ketokonazola ni itrakonazola (> 200 mg/dan).
*Proportion of subjects who had HIV-1 < 400 copies/ml and had remained on study treatment 
*udio ispitanika kojima je razina HIV-1 iznosila < 400 kopija/ml i koji su nastavili primati ispitivano liječenje
CYP3A4 inhibitors increase the exposure of lomitapide, with strong inhibitors increasing exposure approximately 27-fold. 
Inhibitori CYP3A4 povećavaju izloženost lomitapidu, s tim da snažni inhibitori povećavaju izloženost približno 27 puta.
Due to the risk of bedaquiline related adverse events, the combination of bedaquiline and Kaletra should be avoided. 
Zbog rizika od štetnih događaja povezanih s bedakilinom, kombinacija bedakilina i lijeka Kaletra se mora izbjegavati.
For caution on parenterally administered midazolam, see section 4.5. 
Za oprez pri parenteralnoj primjeni midazolama vidjeti dio 4.5.
Based on known metabolic profiles, clinically significant interactions are not expected between Kaletra and dapsone, trimethoprim/sulfamethoxazole, azithromycin or fluconazole. 
Na temelju saznanja o metaboličkim profilima, ne očekuju se klinički značajne interakcije između lijeka Kaletra i dapsona, trimetoprima/sulfametoksazola, azitromicina ili flukonazola.
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: 
KG, Knollstrasse, 67061 Ludwigshafen, Njemačka Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
Based on weight (mg/kg) 
Na temelju težine (mg/kg)
Fluvastatin or Pravastatin 
Fluvastatin ili pravastatin
Uncommon Cerebrovascular accident, convulsion, dysgeusia, ageusia, tremor 
Manje često Cerebrovaskularni incident, konvulzije, disgeuzija, ageuzija, tremor
Rifabutin, 150 mg QD Rifabutin (parent drug and active 25-O-desacetyl metabolite): 
Rifabutin, 150 mg QD Rifabutin (matični lijek i djelatni 25-O-dezacetilni metabolit):
More frequent therapeutic concentration monitoring is recommended until plasma levels of these products have been stabilised. 
Preporučuju se češće kontrole terapijskih koncentracija, sve dok se koncentracije tih pripravaka u plazmi ne stabiliziraju.
Diarrhoea, nausea and vomiting may occur at the beginning of the treatment while hypertriglyceridaemia and hypercholesterolemia may occur later. 
Proljev, mučnina i povraćanje mogu se pojaviti na početku liječenja dok se hipertrigliceridemija i hiperkolesterolemija mogu javiti kasnije.
The effects of Kaletra (in combination with other antiretroviral agents) on biological markers (plasma HIV RNA levels and CD4+ T-cell counts) have been investigated in controlled studies of Kaletra of 48 to 360 weeks duration. 
Učinci lijeka Kaletra (u kombinaciji s ostalim antiretrovirusnim lijekovima) na biološke biljege (razinu HIV RNK u plazmi i broj CD4+ T stanica) ispitivani su u kontroliranim ispitivanjima lijeka Kaletra u trajanju od 48 do 360 tjedana.
The recommended dose of 533/133 mg or 6.5 ml twice daily should not be exceeded. 
Ne smije se premašiti preporučena doza od 533/133 mg ili 6,5 ml dvaput na dan.
• Joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement as some patients taking these medicines may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). 
• Ukočenost zglobova, tupi bolovi i probadanja (osobito u kuku, koljenu i ramenu) i teškoće u kretanju jer neki bolesnici koji uzimaju ove lijekove mogu razviti bolest kostiju koja se naziva osteonekroza (odumiranje tkiva kostiju zbog gubitka opskrbe krvlju).
If you or your child take more Kaletra than you should 
Ako Vi ili Vaše dijete uzmete više lijeka Kaletra nego što ste trebali
If the benefit is considered to outweigh the risk and Kaletra must be used, patients should be carefully monitored for safety. 
Ukoliko se smatra da korist nadmašuje rizik i lijek Kaletra se mora koristiti, bolesnike treba pažljivo nadzirati zbog sigurnosti.
Total amounts of alcohol and propylene glycol from all medicines that are to be given to infants should be taken into account in order to avoid toxicity from these excipients. 
Moraju se uzeti u obzir ukupne količine alkohola i propilenglikola svih lijekova koji će se dati maloj djeci kako bi se izbjegla toksičnost ovih pomoćnih tvari.
The extent of increase depends on the timing of ritonavir administration. 
Opseg povećanja ovisi o vremenu primjene ritonavira.
Interactions with medicinal products 
Interakcije s lijekovima
Astemizole, terfenadine 
Astemizol, terfenadin
Driving or using machines 
Upravljanje vozilima i strojevima
Volume of oral solution twice daily taken with food (80 mg lopinavir/20 mg ritonavir per ml)** 
Volumen oralne otopine za primjenu dvaput na dan s hranom (80 mg lopinavira/ 20 mg ritonavira po ml)**
Weight (kg) 
Tjelesna težina (kg)
• an abnormality in your electrocardiogram (ECG) called atrioventricular block; 
• promjene na elektrokardiogramu (EKG) koje se zovu atrioventrikularni blok;
• avanafil or vardenafil (used to treat erectile dysfunction); 
• avanafil ili vardenafil (lijek za liječenje erektilne disfunkcije);
• elbasvir/grazoprevir (used to treat chronic hepatitis C virus [HCV]); 
• elbasvir/grazoprevir (za liječenje kronične infekcije virusom hepatitisa C [HCV]);
Dosage recommendation for paediatric patients aged from 14 days to 6 months 
Preporuke za doziranje u pedijatrijskih bolesnika u dobi od 14 dana do 6 mjeseci
The systemic exposure to lopinavir/ritonavir at the maternal and developmental toxic dosages was lower than the intended therapeutic exposure in humans. 
Sistemska izloženost lopinaviru/ritonaviru pri dozama koje su izazvale materinsku i razvojnu toksičnost, bila je manja od one koja se pri terapijskim dozama očekuje u ljudi.
Based on the findings in a paediatric study (observed exposures were approximately 35% AUC12 and 75% lower Cmin than in adults), young children from 14 days to 3 months could have sub-optimal exposure with a potential risk of inadequate virologic suppression and emergence of resistance (see section 5.2). 
Temeljem nalaza iz jednog pedijatrijskog ispitivanja (opažene izloženosti bile su približno 35% niža vrijednost AUC12 i 75% niži Cmin nego u odraslih), u male djece u dobi od 14 dana do 3 mjeseca izloženost bi mogla biti manja od optimalne, uz mogući rizik od nedovoljne supresije virusa i razvoja rezistencije (vidjeti dio 5.2).
Kaletra has been shown in vivo to induce its own metabolism and to increase the biotransformation of some medicinal products metabolised by cytochrome P450 enzymes (including CYP2C9 and CYP2C19) and by glucuronidation. 
Utvrđeno je da Kaletra in vivo inducira vlastiti metabolizam i povećava biotransformaciju nekih lijekova koji se metaboliziraju putem enzima citokroma P450 (uključujući CYP2C9 i CYP2C19) i putem glukuronidacije.
4 tablets (400/100 mg) 5 tablets (500/125 mg) 
4 tablete (400/100 mg) 5 tableta (500/125 mg)
Kaletra is likely to increase plasma concentrations of medicinal products that are primarily metabolised by CYP3A. 
Kaletra će vjerojatno povisiti plazmatske koncentracije lijekova koji se prvenstveno metaboliziraju putem CYP3A.
Benzodiazepines Midazolam 
Benzodiazepini Midazolam
It should be kept in mind that the twice weekly dosage of 150 mg may not provide an optimal exposure to rifabutin thus leading to a risk of rifamycin resistance and a treatment failure. 
Mora se imati na umu da doza od 150 mg dvaput na tjedan možda neće omogućiti optimalnu izloženost rifabutinu što može voditi do rezistencije na rifampicin i neuspjeha terapije.
Besides propylene glycol as described above, Kaletra oral solution contains alcohol (42% v/v) which is potentially harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children. 
Osim propilenglikola, kao što je gore navedeno, Kaletra oralna otopina sadrži i alkohol (42% V/V), koji je potencijalno štetan za osobe s bolestima jetre, alkoholizmom, epilepsijom, ozljedama i bolestima mozga, kao i za trudnice i djecu.
• night sweats, itching, rash including raised bumps on the skin, infection of the skin, inflammation of skin or hair pores, accumulation of fluid in the cells or tissues. 
• noćno znojenje, svrbež, osip uključujući ispupčenja na koži, kožne infekcije, upalu kože ili pora dlačica, nakupljanje tekućine u stanicama ili tkivima.
Buproprion and its active metabolite, hydroxybupropion: 
Buproprion i njegov aktivni metabolit hidroksibupropion:
Antibiotic 
Antibiotici
Tenofovir disoproxil fumarate (DF), 300 mg QD 
Tenofovirdizoproksilfumarat (DF), 300 mg QD
Kaletra is not a cure for HIV infection or AIDS. 
Kaletra nije lijek za infekciju HIV-om ili AIDS.
It should not be given when intestinal obstruction is present. 
Ne treba ga davati ako postoji crijevna opstrukcija.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary. 
Mora se evaluirati svaki simptom upale i po potrebi uvesti terapiju.
• abnormal dreams; 
• neuobičajeni snovi;
• midazolam taken orally (taken by mouth), triazolam (used to relieve anxiety and/or trouble sleeping); 
• midazolam primijenjen peroralno (uzet kroz usta), triazolam (lijek za liječenje tjeskobe i/ili smetnji spavanja);
Particular caution must be used when prescribing Kaletra and medicinal products known to induce QT interval prolongation such as: chlorpheniramine, quinidine, erythromycin, clarithromycin. 
Nužan je osobit oprez kada se propisuju Kaletra i lijekovi za koje se zna da produžuju QT-interval kao što su: klorfeniramin, kinidin, eritromicin, klaritromicin.
Contraindicated when used for the treatment of pulmonary arterial hypertension (PAH) only. 
Kontraindiciran kada se koristi samo za liječenje plućne arterijske hipertenzije (PAH).
Lopinavir binds to both alpha-1-acid glycoprotein (AAG) and albumin however, it has a higher affinity for AAG. 
Lopinavir se veže i na alfa-1-kiseli glikoprotein (AAG) i na albumin, no ima veći afinitet za AAG.
Severe hepatic insufficiency. 
Teška jetrena insuficijencija.
The frequency category includes all reported events of moderate to severe intensity, regardless of the individual causality assessment. 
Kategorija učestalosti uključuje sve zabilježene događaje, po težini umjerene do teške, neovisno o individualnoj procjeni povezanosti.
Increased plasma concentrations of alfuzosin which may lead to severe hypotension. 
Povišena koncentracija alfuzosina u plazmi koja može dovesti do teške hipotenzije.
Ranitidine (150 mg single dose) 
Ranitidin (150 mg jednokratna doza)
300/75 mg/m2 (corresponding to 3.75 ml/m2) 
300/75 mg/m2 (što odgovara 3,75 ml/m2)
• Haemophilia type A and B as Kaletra might increase the risk of bleeding. 
• Hemofiliju tip A ili tip B jer Kaletra može povećati rizik od krvarenja.
C24: ↑ 20.70-fold 
C24: ↑ 20,70 puta
The following events have been identified as adverse reactions. 
Niže navedeni događaji su zabilježeni kao nuspojave.
Postpartum n = 17** 
Nakon poroda n = 17**
Alpha1 adrenoreceptor antagonist Alfuzosin 
Alfa1-adrenoreceptor antagonisti Alfuzosin
To enhance bioavailability and minimise variability Kaletra is to be taken with food. 
Kako bi se povećala bioraspoloživost i smanjila biološka varijabilnost, lijek Kaletra treba uzimati s hranom.
QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 39 healthy adults, with 10 measurements over 12 hours on Day 3. 
QTcF interval procijenjen je u randomiziranom, placebom i aktivnim lijekom (moksifloksacin 400 mg jednom dnevno) kontroliranom ukriženom ispitivanju u 39 zdravih osoba, s 10 mjerenja kroz 12 sati tijekom trećeg dana ispitivanja.
Parenteral Midazolam: 
Parenteralni midazolam:
Antipsychotics Lurasidone 
Antipsihotici Lurasidon
Lopinavir is an inhibitor of the HIV-1 and HIV-2 proteases. 
Lopinavir je inhibitor HIV 1 i HIV 2
Co-administration is contraindicated. 
Istodobna primjena je kontraindicirana.
As compared to the BID regimen, the once-daily dosing is associated with a reduction in the Cmin/Ctrough values of approximately 50%. 
U usporedbi s BID režimom, doziranje jednom dnevno je povezano sa smanjenjem Cmin/Ctrough vrijednostima za otprilike 50%.
Overdoses with Kaletra oral solution have been reported (including fatal outcome). 
Zabilježeni su slučajevi predoziranja Kaletra oralnom otopinom (uključujući smrtni ishod).
Between week 24 and 48, patients randomised to a dose of 400/100 mg were converted to a dose of 533/133 mg. 
Između 24. i 48. tjedna bolesnici randomizirani u skupinu koja je primala dozu od 400/100 mg prešli su na dozu od 533/133 mg.
In children 14 days of age and older, the nature of the safety profile is similar to that seen in adults (see Table in section b). 
Kod djece u dobi od 14 dana i starije, sigurnosni profil lijeka sličan je kao i kod odraslih bolesnika (vidjeti tablicu u dijelu b).
In children 2 years of age and older, the nature of the safety profile is similar to that seen in adults (see Table in section b). 
Kod djece stare 2 godine ili više, sigurnosni profil lijeka je sličan kao i kod odraslih bolesnika (vidjeti tablicu u dijelu b).
The 230/57.5 mg/m2 dosage might be insufficient in some children when co-administered with nevirapine or efavirenz. 
Doza od 230/57,5 mg/m2 u neke djece možda neće biti dovoljna kada se primjenjuje istodobno s nevirapinom ili efavirenzom.
Monitoring plasma concentrations of methadone is recommended. 
Preporučuje se praćenje plazmatskih koncentracija metadona.
In vitro selection of resistance 
In vitro izdvojena rezistencija
Further dosage reduction of rifabutin to 150 mg twice weekly on set days is recommended for patients in whom the 150 mg dose 3 times per week is not tolerated. 
Daljnje smanjenje doze rifabutina na 150 mg dvaput tjedno u određene dane se preporučuje kod bolesnika koji ne podnose dozu od 150 mg 3 puta tjedno.
Gender, Race and Age 
Spol, rasa i dob
• Symptoms of dizziness, lightheadedness, fainting or sensation of abnormal heartbeats. 
• Simptome omaglice, ošamućenost, nesvjesticu ili osjećaj nepravilnih otkucaja srca.
Sustained virological response to Kaletra (in combination with nucleoside/nucleotide reverse transcriptase inhibitors) has been also observed in a small Phase II study (M97-720) through 360 weeks of treatment. 
Održani virološki odgovor na lijek Kaletra (u kombinaciji s nukleozidnim/nukleotidnim inhibitorima reverzne transkriptaze) zabilježen je i u malom ispitivanju II. faze (M97-720), u kojem su bolesnici primali terapiju 360 tjedana.
The combined effects may lead to increased blood alcohol levels and increase the side effects of alcohol. 
Objedinjeni učinci mogu dovesti do povišenih razina alkohola u krvi i pojačati nuspojave alkohola.
16/4 mg/kg (corresponding to 0.2 ml/kg) 
16/4 mg/kg (što odgovara 0,2 ml/kg)
3rd Trimester n = 23 
3. tromjesečje n = 23
Erectile dysfunction medicines (avanafil, vardenafil, sildenafil, tadalafil) 
Lijekovi za liječenje erektilne disfunkcije (avanafil, vardenafil, sildenafil, tadalafil)
This medicinal product does not require any special storage conditions. 
Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
2nd Trimester n = 17* 
2. tromjesečje n = 17*
* Body surface area can be calculated with the following equation: 
* Površina tijela (PT) može se izračunati sljedećom formulom:
The dose should be administered using a calibrated 2 ml or 5 ml oral dosing syringe best corresponding to the volume prescribed. 
Lijek treba primjenjivati graduiranom štrcaljkom za peroralnu primjenu volumena 2 ml ili 5 ml koja najbolje odgovara propisanom volumenu.
The combination should be used with caution and a lower dose of trazodone should be considered. 
Ta kombinacija se mora primjenjivati s oprezom i razmotriti primjena manje doze trazodona.