natgillin/translations-raw huggingface dataset:
Single oral doses of 10 mg and 80 mg of vardenafil have been shown to prolong the QTc interval by a mean of 8 msec and 10 msec, respectively. 
Enkratna peroralna odmerka 10 mg in 80 mg vardenafila podaljšata dobo QT povprečno za 8 oz. 10 msec. Enkratni odmerek 10 mg vardenafila uporabljen sočasno s 400 mg gatifloksacina, učinkovino, ki ima podoben učinek na QT dobo, se doba QT podaljša za 4 msec v primerjavi s posamezno učinkovino.
Tinnitus 
- tesnoba
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja eritem izpuščaj fotosenzitivna reakcija
- Place the entire orodispersible tablet in the mouth, on the tongue, where it will dissolve in seconds, then swallow with saliva. 
Tableta se bo raztopila v nekaj sekundah, pogoltnite jo s slino.
In a clinical trial in post-prostatectomy patients, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg. 
V kliničnem preskušanju pri bolnikih po prostatektomiji, v kateri so primerjali placebo z 10- in 20miligramskimi odmerki vardenafila, je vardenafil pomembno izboljšal erektilno funkcijo, zmožnost doseganja in ohranjanja erekcije (omogočen je bil uspešen spolni odnos), ter otrdelost penisa.
Each tablet contains 10 mg vardenafil (as hydrochloride). 
Ena tableta vsebuje 10 mg vardenafila v obliki vardenafilijevega klorida.
Contents of the pack and other information What Levitra contains 
Shranjevanje zdravila Levitra Vsebina pakiranja in dodatne informacije
In a clinical trial in patients with diabetes mellitus, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg. 
V kliničnem preskušanju, v katerem so sodelovali bolniki s sladkorno boleznijo in v kateri so primerjali placebo z 10- in 20-miligramskimi odmerki vardenafila, se je zaradi uporabe vardenafila pomembno izboljšala erektilna funkcija, zmožnost doseganja in ohranjanja erekcije (omogočen je bil uspešen spolni odnos), ter otrdelost penisa.
EU/1/03/248/001 2 tablets EU/1/03/248/002 4 tablets EU/1/03/248/003 8 tablets EU/1/03/248/004 12 tablets EU/1/03/248/021 20 tablets 
EU/1/03/248/002 4 tablete EU/1/03/248/003 8 tablet EU/1/03/248/004 12 tablet EU/1/03/248/021 20 tablet
With other alpha-blockers a time separation of dosing should be considered when vardenafil is prescribed concomitantly (see section 4.5). 
Pri sočasnem zdravljenju z vardenafilom in drugimi zaviralci adrenergičnih receptorjev alfa je potreben med zaužitjem enega in drugega zdravila časovni presledek (glejte poglavje 4.5).
Talk to a doctor without taking 
Preden začnete jemati zdravilo
In patients with severe renal impairment (creatinine clearance <30 ml/min), a starting dose of 5 mg should be considered. 
Začetni odmerek za bolnike s hudo ledvično okvaro (kreatininski očistek < 30 ml/min) je 5 mg. Glede na učinkovitost zdravila in dejstvo, kako ga bolnik prenaša, se ga lahko poveča na 10 mg in 20 mg.
Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora nosna kongestija dispneja sinusna kongestija epistaksa
Sudden death 
Jetrna okvara
Levitra is not for use by women. 
Nosečnost in dojenje Zdravilo Levitra ni namenjeno ženskam.
Vardenafil dose adjustment might be necessary if moderate CYP3A4 inhibitors such as erythromycin and clarithromycin, are given concomitantly (see sections 4.5 and 4.2). 
Med sočasno uporabo zmernih zaviralcev CYP3A4 (npr. eritromicin in klaritromicin), je treba odmerek vardenafila po potrebi prilagoditi (glejte poglavji 4.5 in 4.2).
Vardenafil dose adjustment might be necessary if moderate CYP3A4 inhibitors such as erythromycin and clarithromycin, are given concomitantly (see section 4.2 and 4.5). 
Med sočasno uporabo zmernih zaviralcev CYP3A4 (npr. eritromicin in klaritromicin), je treba odmerek vardenafila po potrebi prilagoditi (glejte poglavji 4.2 in 4.5).
Each orodispersible tablet contains 10 mg of vardenafil (as hydrochloride). 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena orodisperzibilna tableta vsebuje 10 mg vardenafila v obliki vardenafilijevega klorida.
Do you currently use or take contraceptives? 
Ali trenutno uporabljate ali jemljete kontraceptive?
Date of first authorisation: 24 June 2013 Date of latest renewal: 8 January 2018 
Datum prve odobritve: 24. junij 2013 Datum zadnjega podaljšanja: 08. januar 2018
• primary (with no identified cause or familial); 
• primarna (brez ugotovljenega vzroka ali družinska),
Efficacy has been shown in: 
Učinkovitost je bila ugotovljena pri:
It is especially important to tell your doctor if you are taking: 
Še posebej pomembno je, da obvestite zdravnika, če jemljete:
He recovered completely within 24 hours with blood pressure support. 
V 24 urah si je ob podpori krvnemu tlaku povsem opomogel.
A clinically significant reduction of efficacy cannot be excluded. 
Klinično pomembnega zmanjšanja učinkovitosti ne moremo izključiti.
The results did not indicate an additional benefit of bosentan in this population: 
Rezultati ne kažejo na dodatno korist bosentana pri tej populaciji:
4 These types of reactions can also be related to the underlying disease. 
4 Te vrste reakcij so lahko tudi posledica osnovne bolezni.
This patient recovered within the 60-day follow-up period. 
Ta bolnik je v 60dnevnem obdobju spremljanja okreval.
Date of first monthly test: _________________________________ 
Datum prvega mesečnega testa: _________________________________
Animal models 
Živalski modeli
The table below illustrates the pre-specified protocol analyses. 
Spodnja preglednica kaže predspecificirane analize protokola.
Signs that your liver may not be working properly include: 
Znaki, da morda jetra ne delujejo pravilno, vključujejo:
Appropriate monitoring of the HIV therapy is recommended. 
Priporoča se ustrezno nadziranje zdravljenja HIV.
6-Minute Walk Distance (m) 
Razdalja, prehojena v 6 minutah (m)
The mechanism of this adverse effect is unclear. 
Mehanizem tega neželenega učinka ni jasen.
The primary objective was to show that bosentan did not worsen hypoxaemia. 
Primarni cilj je bil pokazati, da bosentan ni poslabšal hipoksemije.
Invasive haemodynamic parameters were assessed in the first study only. 
Invazivne hemodinamske parametre so ocenjevali samo v prvi študiji.
There was no decrease to below 8 g/dL. 
Znižanj pod vrednost 8 g/dl ni bilo.
It is important that you have these tests as ordered by your doctor. 
Pomembno je, da opravljate te preiskave, ki jih naroči zdravnik.
Your name: __________________________________________________ Prescribing doctor: ________________________________________ If you have questions about STAYVEER ask your doctor. 
Vaše ime: __________________________________________________ Zdravnik, ki je zdravilo predpisal: _______________________________ Če imate kakšna vprašanja o zdravilu STAYVEER, se posvetujte z zdravnikom.
> 8 × ULN 
> 8  ZMN
The patient's response to treatment and need for continued therapy should be re-evaluated on a regular basis. 
Odziv bolnika na zdravljenje in potrebo po nadaljnji terapiji moramo redno ponovno ocenjevati.
• if you are pregnant, or could get pregnant because you are not using reliable contraceptive methods. 
• če ste noseči ali lahko zanosite, ker ne uporabljate zanesljivih kontracepcijskih metod.
Tests your doctor will do during treatment 
Testi, ki jih bo vaš zdravnik opravil med zdravljenjem
The clinical benefit of the combination has not been demonstrated. 
Klinične koristi kombinacije niso dokazali.
The mean treatment duration was 45 weeks. 
Povprečno je zdravljenje trajalo 45 tednov.
Increasing the dose or the dosing frequency will likely not result in additional clinical benefit. 
Povečanje odmerka ali pogostnosti odmerjanja verjetno ne bo imelo za posledico dodatnih kliničnih koristi.
EXP {MM/YYYY} Use within 30 days after the first opening 
EXP: {MM/LLLL} Uporabite v 30 dneh po prvem odprtju.
The majority of patients were diagnosed with idiopathic or heritable PAH (61%). 
Večina bolnikov je bila diagnosticirana z idiopatsko ali podedovano PAH (61 %).
Your doctor will advise you on your dosing. 
Vaš zdravnik vam bo svetoval vaš odmerek.
Less than 3% of an administered oral dose is recovered in urine. 
Manj kot 3 % danega peroralnega odmerka se izloči v urinu.
The consequences of these findings regarding hepatotoxicity are unknown. 
Posledice teh izsledkov glede hepatotoksičnosti niso znane.
However, full induction by bosentan might not have been reached and a further decrease of protease inhibitors cannot be excluded. 
Vendar pa popolna indukcija z bosentanom morda ni bila dosežena, zato nadaljnjega zmanjševanja zaviralcev proteaze ni mogoče izključiti.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 
Obvestite zdravnika ali farmacevta, če jemljete, ali ste pred kratkim jemali katerokoli zdravilo, vključno z zdravili, ki ste jih dobili brez recepta.
In healthy subjects, the absolute bioavailability of bosentan is approximately 50% and is not affected by food. 
Pri zdravih osebah je absolutna biološka uporabnost bosentana približno 50 % in ni odvisna od hrane.
This lowers the blood pressure and relieves the symptoms. 
tem se zniža krvni tlak in lajšajo simptomi.
Blurred vision have also been reported at an unknown frequency (frequency cannot be estimated from the available data). 
Poročali so tudi o zamegljenem vidu, z neznano pogostnostjo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
The plasma concentrations of bosentan were also decreased by 29%. 
Plazemske koncentracije bosentana so se tudi znižale za 29 %.
Based on these findings and preclinical data, it cannot be excluded that bosentan may have a detrimental effect on spermatogenesis in men. 
Na podlagi teh ugotovitev in predkliničnih podatkov ni mogoče izključiti možnosti, da ima lahko bosentan škodljiv učinek na spermatogenezo pri moških.
If you suspect you may be pregnant, tell your doctor or gynaecologist. 
Če sumite, da ste morda noseči, to povejte zdravniku ali ginekologu.
The maximum plasma concentrations are attained within 3-5 hours. 
Maksimalne plazemske koncentracije dosega v 3-5 urah.
Patients could receive additional PAH treatment as required in the open-label extension. 
Bolniki so lahko prejemali dodatno zdravljenje PAH, kot je bilo potrebno v odprtem podaljšku.
Bosentan is highly bound (> 98%) to plasma proteins, mainly albumin. 
Bosentan se v veliki meri veže (> 98 %) na plazemske beljakovine, zlasti na albumine.
Important Safety Alerts for Patients taking STAYVEER (bosentan) 
Pomembna varnostna opozorila za bolnike, ki jemljejo zdravilo STAYVEER (bosentan)
The film-coated tablets are to be swallowed with water. 
Filmsko obložene tablete se zaužijejo z vodo.
The combination is not recommended. 
Te kombinacije ne priporočamo.
ULN = upper limit of normal 
ZMN = Zgornja meja normalnih vrednosti
If you forget to take STAYVEER, take a dose as soon as you remember, then continue to take your tablets at the usual times. 
Če ste pozabili vzeti zdravilo STAYVEER, vzemite odmerek takoj, ko se spomnite, nato nadaljujte z jemanjem tablet ob običajnem času.
This combination should not be used. 
Te kombinacije ne smemo uporabljati.
In both studies, treatment with bosentan resulted in significant increases in exercise capacity. 
V obeh študijah je zdravljenje z bosentanom pripeljalo do pomembnega povečanja fizične zmogljivosti.
Warnings and precautions Tests your doctor will do before treatment 
Opozorila in previdnostni ukrepi Preiskave, ki jih bo vaš zdravnik opravil pred zdravljenjem
These will be done every month for the first 4 months of treatment, then every 3 months after that, as patients taking STAYVEER may get anaemia. 
Opravijo se vsak mesec v prvih 4 mesecih zdravljenja, nato pa vsake 3 mesece, saj lahko bolniki, ki jemljejo zdravilo STAYVEER, postanejo slabokrvni.
Please read the information under “Contraceptives” and “Other medicines and STAYVEER” 
Preberite informacije v poglavju „Kontraceptivi“ in „Druga zdravila in zdravilo STAYVEER“,
This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult. 
To zmanjša količino kisika, ki lahko pride v kri v pljučih, zato je fizična aktivnost otežena.
No clinically relevant differences in adverse reactions were observed between the overall dataset and the approved indications. 
Klinično pomembnih razlik v neželenih učinkih med vsemi podatki in odobrenimi indikacijami niso opazili.
There are no reliable data on the use of STAYVEER in pregnant women. 
Na voljo ni zanesljivih podatkov o uporabi zdravila STAYVEER pri nosečnicah.
Bosentan does not penetrate into erythrocytes. 
Bosentan ne prodre v eritrocite.
If you have the impression that the effect of STAYVEER is too strong or too weak, talk to your doctor in order to find out whether your dose needs to be changed. 
Če menite, da je učinek zdravila STAYVEER premočan ali prešibak, se posvetujte z zdravnikom, da ugotovite, ali je treba spremeniti vaš odmerek.
In this study, the exposure to bosentan decreased with time in a manner consistent with the known auto-induction properties of bosentan. 
V tej študiji se je izpostavljenost bosentanu manjšala s časom na način, ki se je ujemal z znanimi samoindukcijskimi lastnostmi bosentana.
Only one death occurred in each treatment group during the 6-month double-blind study period, therefore no conclusion can be drawn on survival. 
vsaki skupini je v času 6-mesečnega obdobja dvojno slepe študije umrla po ena oseba, zato o preživetju ni mogoče sklepati.
Haemodynamics were measured in 17 patients. 
Hemodinamske kazalce so merili pri 17 bolnikih.
95% CL 
95-% MZ
In the event of late clinical deterioration despite treatment with STAYVEER (i.e., after several months of treatment), the treatment should be re-assessed. 
V primeru kasnejšega poslabšanja kliničnega stanja kljub zdravljenju z zdravilom STAYVEER (tj. po nekaj mesecih zdravljenja) je treba zdravljenje ponovno oceniti.
• Anaemia (low blood value) which may affect up to 1 in 10 people. 
• anemija (nizke krvne vrednosti), ki se lahko pojavi pri največ 1 od 10 bolnikov.
The mechanism for this interaction may be induction of P-glycoprotein. 
Mehanizem tega medsebojnega delovanja je lahko indukcija P-glikoproteina.
For further information see sections 4.5 and 4.6. 
Za več informacij glejte poglavji 4.5 in 4.6.
This card contains important information about STAYVEER. 
Kartica vsebuje pomembne informacije o zdravilu STAYVEER.
Monitoring of aminotransferase levels should be continued at least every 2 weeks. 
Spremljanje ravni aminotransferaz naj se nadaljuje vsaj na vsaka 2 tedna.
STAYVEER reduces the number of new finger and toe ulcers that appear. 
STAYVEER zmanjšuje število novih razjed prstov na rokah in nogah, ki se pojavijo.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after “EXP”. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici in pretisnem omotu poleg oznake „EXP“.
The safety profile of the combination was not different from the one expected with each component and the combination therapy was well tolerated in children and adults. 
Varnostni profil kombinacije se ni razlikoval od profila, ki bi ga pričakovali za vsako posamezno zdravilo, kombinirano zdravljenje pa so dobro prenašali tako otroci kot odrasli.
If you are a woman of childbearing age read this page carefully 
Ženske v rodni dobi naj skrbno preberejo to stran
If a clinically relevant decrease in haemoglobin concentration occurs, further evaluation and investigation should be undertaken to determine the cause and need for specific treatment. 
Če pride do klinično pomembnega znižanja koncentracije hemoglobina, opravimo dodatna vrednotenja in preiskave, da ugotovimo vzrok in potrebo po specifičnem zdravljenju.
• One patient in the bosentan group had treatment failure (need for ECMO as per protocol definition), which was declared based on increasing Oxygenation Index values within 8 h after the first study drug dose. 
• Pri enem bolniku v skupini z bosentanom zdravljenje ni bilo uspešno (potreba po ECMO po opredelitvi v protokolu), kar je bilo ugotovljeno na podlagi naraščajočih vrednosti oksigenacijskega indeksa v 8 urah po prvem odmerku študijskega zdravila.
Due to the potential for interactions related to the inducing effect of bosentan on CYP450 (see section 4.5), which could affect the efficacy of antiretroviral therapy, these patients should also be monitored carefully regarding their HIV infection. 
Zaradi možnosti medsebojnega delovanja v povezavi z učinkom bosentana na indukcijo encima CYP450 (glejte poglavje 4.5), ki bi lahko vplivalo na učinkovitost protiretrovirusnega zdravljenja, moramo te bolnike skrbno spremljati tudi v smislu njihove okužbe s HIV.
Other medicines and STAYVEER 
Druga zdravila in zdravilo STAYVEER
The advice of a hepatologist is recommended. 
Priporočamo posvet s hepatologom.
Due to limited data in children below 2 years of age, pharmacokinetics remain not well characterised in this age category. 
Zaradi pomanjkljivih podatkov pri otrocih, mlajših od 2 let, ostaja farmakokinetika pri tej starostni skupini slabše opredeljena.
Syncope1, 4 
pogosti sinkopa1, 4
What STAYVEER is and what it is used for 
Kaj je zdravilo STAYVEER in za kaj ga uporabljamo
Based on the investigated range of each variable, it is not expected that the pharmacokinetics of bosentan will be influenced by gender, body weight, race, or age in the adult population to any relevant extent. 
Na podlagi raziskanega razpona za vsako spremenljivko ne pričakujemo, da bi na farmakokinetiko bosentana pomembno vplival spol, telesna masa, rasa ali starost odrasle populacije.
You are advised to stop breast-feeding if STAYVEER is prescribed for you, because it is not known whether this medicine passes into breast milk. 
Svetujemo vam, da prenehate dojiti, če ste dobili predpisano zdravilo STAYVEER, saj ni znano, ali se to zdravilo izloča v mleko.
Re-introduction of treatment 
Ponovna uvedba zdravljenja
Some improvements have also been shown in patients with class II PAH. 
Nekatera izboljšanja so opazili tudi pri bolnikih s PAH II.
If there is any doubt about what contraceptive advice should be given to the individual patient, consultation with a gynaecologist is recommended. 
V primeru dvoma v zvezi z načinom kontracepcije, ki se svetuje posamični bolnici, se priporoča posvetovanje z ginekologom.
No dose adjustment is required in patients over the age of 65 years. 
Prilagajanje odmerka pri bolnikih, starejših od 65 let, ni potrebno.
Tadalafil did not affect the exposure (AUC and Cmax) of bosentan or its metabolites. 
Tadalafil ni vplival na izpostavljenost (AUC in Cmax) bosentanu ali njegovim presnovkom.
It is not known whether bosentan is excreted into human breast milk. 
Ni znano, ali se bosentan izloča v materino mleko.
This interaction is unlikely to be of clinical relevance. 
Malo verjetno je, da bi bilo to medsebojno delovanje klinično pomembno.
Your doctor or gynaecologist will advise you about reliable contraceptive methods while taking STAYVEER. 
Vaš zdravnik ali ginekolog vam bo svetoval glede zanesljivih kontracepcijskih metod v času jemanja zdravila STAYVEER.
However, decreases in exposure were as much as 56% and 66%, respectively, in individual subjects. 
Pri posameznicah pa so bila zmanjšanja izpostavljenosti tudi do 56 % oziroma 66 %.
Monitoring of cholesterol levels and subsequent dosage adjustment should be considered. 
Razmislite o spremljanju ravni holesterola in posledično prilagoditvi odmerka.
If you notice any of these signs tell your doctor immediately 
Če opazite katerega od teh znakov, nemudoma obvestite svojega zdravnika.
It is recommended that haemoglobin concentrations be checked prior to initiation of treatment, every month during the first 4 months, and quarterly thereafter. 
Priporočamo, da koncentracije hemoglobina preverite pred začetkom zdravljenja, vsak mesec v prvih štirih mesecih, zatem pa vsako četrtletje.
Your doctor may tell you to reduce the dose over a few days before stopping completely. 
Vaš zdravnik vam bo morda odmerek postopoma zniževal (nekaj dni), preden popolnoma prekinete z zdravljenjem.
Half of the patients in each group were already being treated with intravenous epoprostenol and the dose of epoprostenol remained constant for the duration of the study. 
Polovica bolnikov v vsaki skupini je že prejemala epoprostenol intravensko, odmerek epoprostenola je med trajanjem študije ostal nespremenjen.
• Abnormal liver function which may affect more than 1 in 10 people 
• nenormalno delovanje jeter, ki se lahko pojavi pri več kot 1 od 10 bolnikov
Changes in exercise test parameters at week 12 from baseline were highly variable and none were significant. 
Spremembe parametrov za vadbeni preskus so bile v 12. tednu glede na izhodiščne vrednosti zelo spremenljive in nobena ni bila značilna.
Controlled clinical study experience in this indication is limited to 6 months (see section 5.1). 
Izkušnje iz nadzorovane klinične študije so pri tej indikaciji omejene na 6 mesecev (glejte poglavje
Consequently, it is recommended that patients be monitored for signs of fluid retention (e.g., weight gain), especially if they concomitantly suffer from severe systolic dysfunction. 
Zato priporočamo, da bolnike opazujete glede pojava znakov zadrževanja tekočine (denimo, povečanje telesne mase) in to še zlasti, če imajo sočasno hudo sistolično disfunkcijo.
The safety profile in this pooled analysis of uncontrolled paediatric studies was similar to that observed in the pivotal trials in adult patients with PAH except for infections, which were more frequently reported than in adults (69.0% vs 41.3%). 
Varnostni profil v tej združeni analizi nenadzorovanih pediatričnih študij je bil podoben kot v ključnih preskušanjih pri odraslih bolnikih s PAH, z izjemo okužb, o katerih so poročali pogosteje kot pri odraslih (69,0 % v primerjavi z 41,3 %).
Clearance and volume of distribution decrease with increased intravenous doses and increase with time. 
Očistek in volumen porazdelitve se zmanjšujeta z višanjem intravenskega odmerka in večata s časom.
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
Kot vsa zdravila lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The relative contributions of previous placebo treatment in the double-blind phase and of other medications started during the open-label extension period are unknown. 
Relativni prispevek predhodnega zdravljenja s placebom v dvojno slepi fazi in druga zdravila, uvedena v obdobju odprtega podaljška, niso znani.
1 Data derived from post-marketing experience, frequencies based on statistical modelling of placebo-controlled clinical trial data. 
1 Pogostnosti pri podatkih, pridobljenih iz izkušenj v obdobju trženja, temeljijo na statističnem modelu podatkov s placebom kontroliranih kliničnih preskušanj.
Pharmacotherapeutic group: other antihypertensives, ATC code: C02KX01 
Farmakoterapevtska skupina: drugi antihipertenzivi, oznaka ATC: C02KX01 Mehanizem delovanja
Therefore, if you feel dizzy or that your vision is blurred while taking STAYVEER, do not drive or operate any tools or machines. 
Če ste v času jemanja zdravila STAYVEER omotični ali imate zamegljen vid, ne vozite in ne upravljajte nobenega orodja ali strojev.
No recommendation on a posology can be made (see sections 5.1 and 5.2). 
Priporočil o odmerjanju ni mogoče dati (glejte poglavji 5.1 in 5.2).
• Neutropenia/leukopenia (low number of white blood cells) 
• nevtropenija/levkopenija (nizko število belih krvničk)
Re-introduction must follow the guidelines detailed in section 4.2. 
Pri ponovni uvedbi zdravljenja se ravnamo po smernicah, opisanih v poglavju 4.2.