natgillin/translations-raw huggingface dataset:
Symptoms of infection - inform your doctor immediately.
simptomi okužbe - nemudoma obvestite svojega zdravnika.
Children (2 - 12 years of age) will start with a dose smaller than this and continue up to the maximum allowed for their size.
Otroci (stari od 2 do 12 let) začnejo z manjšim odmerkom od navedenega in nadaljujejo do največjega dovoljenega odmerka za svojo velikost.
AUC12 or 24
AUC12 ali 24
Tell your doctor as soon as possible if this applies to you.
Zdravniku čim prej povejte, če se vam to zgodi.
Currently available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.
Podatki, ki so trenutno na razpolago, so opisani v poglavjih 5.1 in 5.2, toda priporočil glede odmerjanja ni mogoče postaviti.
A causal relationship has been evoked, although the mechanism of action has not been elucidated.
Izkazalo se je, da gre za vzročno razmerje, čeprav mehanizem delovanja ni razjasnjen.
Discuss with your physician the precautions needed to avoid infecting other people.
Posvetujte se s svojim zdravnikom o ukrepih, ki so potrebni, da se izognete okužbi drugih ljudi.
This was consistent with the observations in animal studies.
To se sklada z opažanji študij na živalih.
Therefore, an alternative, effective and safe method of contraception should be used during treatment.
Zato je treba med zdravljenjem uporabiti drug, učinkovit in varen način kontracepcije.
Digoxin (heart medicine).
Digoksin (zdravilo za srce).
Currently, there are no data specific to this patient population and therefore specific dosage recommendations cannot be made.
Specifičnih podatkov za to skupino bolnikov trenutno ni, zato ni mogoče dati specifičnih priporočil za odmerjanje.
Therefore concomitant use is not recommended.
Sočasna uporaba zato ni priporočljiva.
Ritonavir can be used during pregnancy if clinically needed.
Ritonavir se lahko uporabi med nosečnostjo, če je to klinično potrebno.
The mechanism of this interaction is not clear, but may be the result of transporter inhibition.
Mehanizem tega medsebojnega delovanja ni jasen, vendar je možno, da gre za posledico zaviranja transporterja.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness: 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); not known (cannot be estimated from the available data).
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti: 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; neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Your doctor will discuss with you the best combination of medicines for you.
Zdravnik se bo z vami pogovoril o tem, katera kombinacija zdravil je za vas najboljša.
Sildenafil or tadalafil for impotence (erectile dysfunction).
Sildenafil ali tadalafil za impotenco (erektilno disfunkcijo).
The time to maximum concentration (Tmax) remained constant at approximately 4 hours with increasing dose.
Čas do maksimalne koncentracije (tmax) je z naraščajočimi odmerki ostal stalen, približno 4 ure.
Regular blood tests may be required to check your liver is working properly.
Morda bodo potrebne redne preiskave krvi za preverjanje, ali vam jetra delujejo normalno.
Ritonavir was the first protease inhibitor (approved in 1996) for which efficacy was proven in a study with clinical endpoints.
Ritonavir je bil prvi zaviralec proteaz (odobren leta 1996), katerega učinkovitost je bila dokazana v študiji s kliničnimi končnimi točkami.
Cl/F (L/h) 1 Values expressed as geometric means.
Oč/F (l/uro) 1 Vrednosti so izražene kot geometrične sredine.
Moreover, in case of withdrawal of glucocorticoids progressive dose reduction may be required over a longer period.
Poleg tega utegne biti v primeru opustitve glukokortikoidov potrebno postopno zmanjševanje odmerka v daljšem obdobju.
It is believed that this happens because the body's immune response improves and helps the body to fight these infections.
Domnevno se to zgodi, ker si imunski sistem opomore in telesu pomaga premagovati te okužbe.
Reduction in the antiretroviral activity of ritonavir is primarily associated with the protease mutations V82A/F/T/S and I84V.
Zmanjšanje protiretrovirusnega delovanja ritonavirja je v prvi vrsti povezano z mutacijami proteaz V82A/F/T/S in I84V.
Consideration should be given to official guidance on the appropriate treatment of tuberculosis in HIV-infected patients.
Upoštevati je treba uradne smernice za ustrezno zdravljenje tuberkuloze pri bolnikih, okuženih s HIV.
There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production.
Ni podatkov o učinkih ritonavirja na dojenega otroka ali o učinkih zdravila na proizvodnjo mleka.
These interactions are noted in the medicinal product interaction tables below.
Ta medsebojna delovanja so navedena v spodnjih tabelah interakcij.
Tell your doctor if you are taking tadalafil for pulmonary arterial hypertension.
Povejte svojemu zdravniku, če jemljete tadalafil za pljučno arterijsko hipertenzijo.
Talk to your doctor or pharmacist if you need five or more tablets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.
Posvetujte se z zdravnikom ali farmacevtom, če potrebujete pet ali več tablet dnevno daljše časovno obdobje, še zlasti, če so vam svetovali dieto z majhnim vnosom soli (natrija).
You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Še vedno lahko prenašate HIV medtem, ko jemljete to zdravilo, čeprav je tveganje zmanjšano z učinkovitim protivirusnim zdravljenjem.
On rare occasions these muscle disorders have been serious (rhabdomyolysis).
V redkih primerih so bile te mišične motnje resne (rabdomioliza).
If you miss a dose, take the missed dose as soon as possible.
Če ste pozabili vzeti odmerek, izpuščeni odmerek vzemite čimprej.
In more than a half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
V več kot polovici opisanih primerov so zdravljenje z zaviralci proteaz nadaljevali oz. ga znova vpeljali, če je bilo pred tem prekinjeno.
Should this happen to you, seek immediate advice from your doctor.
Če se to zgodi vam, morate svojega zdravnika nemudoma vprašati za nasvet.
Some patients with advanced HIV infection (AIDS) who then start anti-HIV treatment may develop the symptoms of infections they have had in the past even if they didn't know they had had them.
Nekaterim bolnikom, ki imajo napredovalo okužbo s HIV (AIDS) in začnejo jemati zdravila proti HIV, se lahko pojavijo simptomi okužb, ki so jih imeli kdaj v preteklosti, tudi če sploh ne vedo, da so jih imeli.
Do not use this medicine after the expiry date on the carton or bottle label after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali steklenici poleg oznake »EXP«.
Tell your doctor if you have/had:
Povejte svojemu zdravniku, če imate ali ste kdaj imeli:
This should be particularly taken into account for those on a low sodium diet.
To je treba še posebej upoštevati pri tistih, ki so na dieti z majhno vsebnostjo natrija.
Treatment of overdose with ritonavir should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Zdravljenje prevelikega odmerjanja ritonavirja mora obsegati splošne podporne ukrepe, vključno z nadziranjem vitalnih znakov in opazovanjem bolnikovega kliničnega stanja.
Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
V poštev pride prilagoditev odmerjanja midazolama, zlasti če je uporabljen več kot en sam odmerek midazolama.
Component of a multipack can't be sold separately.
Sestavni deli skupnega pakiranja niso v prodaji ločeno.
If you have any other health concerns, discuss these with your doctor as soon as you can.
če imate kakšne druge zdravstvene pomisleke, se o njih čimprej posvetujte z zdravnikom.
During episodes of diarrhoea your doctor may decide that extra monitoring is needed.
Med obdobji driske bo zdravnik morda presodil, da potrebujete dodatno spremljanje.
This is equivalent to 4.4% of the recommended maximum daily dietary intake of sodium for an adult.
To ustreza 4,4 % priporočenega največjega dnevnega vnosa natrija s hrano za odraslega.
The dose and/or frequency of use of these medicines may need to be reduced to avoid hypotension and prolonged erection.
Odmerek in/ali pogostnost uporabe teh zdravil bo morda treba zmanjšati, da bi preprečili hipotenzijo in dolgotrajno erekcijo.
Some patients taking ritonavir may experience changes in the electrocardiogram (ECG).
Nekaterim bolnikom, ki jemljejo ritonavir, se lahko pojavijo spremembe na elektrokardiogramu (EKG).
A large amount (6100 live births) of pregnant women were exposed to ritonavir during pregnancy; of these, 2800 live births were exposed during the first trimester.
Med nosečnostjo je bilo ritonavirju izpostavljeno veliko število (6100 živorojenih) nosečnic; od tega je bilo 2800 živorojenih izpostavljenih v prvem trimesečju.
In this instance, close clinical monitoring is warranted.
V tem primeru je potrebno skrbno klinično spremljanje.
ND: Not determined.
ND: Ni določeno.
Renal clearance averaged less than 0.1 l/h and was relatively constant throughout the dosage range.
Ledvični očistek je bil v povprečju manj kot 0,1 l/uro in je bil v vsem odmernem območju razmeroma stalen.
Your doctor may wish to reduce the steroid dose or monitor your side effects more closely.
Zdravnik vam bo morda zmanjšal odmerek steroida ali pa bo natančneje spremljal vaše neželene učinke.
Tissue distribution studies with
Raziskave porazdelitve v tkivih s
There is no parenteral formulation of ritonavir, therefore the extent of absorption and absolute bioavailability have not been determined.
Parenteralnega pripravka ritonavirja ni, zato delež absorpcije in absolutna biološka uporabnost nista ugotovljeni.
ND: Not determined
ND: ni določeno
Response was similar in both dosing regimens and across patient age.
Odziv je bil podoben pri obeh shemah odmerjanja in ne glede na starost bolnika.
Ritonavir penetrates minimally into the brain.
Ritonavir minimalno prodira v možgane.
Also read the list of medicines under ‘Other medicines and Ritonavir Mylan' for use with certain other medicines which require special care.
Preberite tudi seznam zdravil pod naslovom ''Druga zdravila in zdravilo Ritonavir Mylan'' glede uporabe z nekaterimi drugimi zdravili, ki zahtevajo posebno pozornost.
Even if you feel better, do not stop taking Ritonavir Mylan without talking to your doctor.
Tudi če se počutite bolje, ne prenehajte jemati zdravila Ritonavir Mylan, ne da bi se posvetovali s svojim zdravnikom.
To avoid transmitting the infection, mothers with HIV must not breast-feed their babies.
Da bi preprečili prenos okužbe, matere, ki so okužene s HIV, ne smejo dojiti.
Other pharmaceutical forms/strengths may be more appropriate for administration to this population.
Za to populacijo so morda bolj primerne druge farmacevtske oblike/jakosti.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Če se bolezen jeter pri takšnih bolnikih poslabša, pride v poštev prekinitev ali prenehanje zdravljenja.
It is recommended that a condom or other non-hormonal method of contraception is used instead.
Priporočljivo je, da namesto tega uporabljate kondome ali druge nehormonske načine kontracepcije.
This medicine contains 87.75 mg of sodium in each tablet.
To zdravilo vsebuje 87,75 mg natrija v vsaki tableti.
Accumulation of other mutations in the protease gene (including at positions 20, 33, 36, 46, 54, 71, and 90) can also contribute to ritonavir resistance.
K odpornosti proti ritonavirju lahko pripomore tudi kopičenje drugih mutacij na proteaznem genu (vključno s položaji 20, 33, 36, 46, 54, 71 in 90).
Erectile dysfunction, as the medicines used to treat erectile dysfunction can cause hypotension and prolonged erection.
erektilno disfunkcijo, saj zdravila, ki se uporabljajo za zdravljenje erektilne disfunkcije lahko povzročijo hipotenzijo in dolgotrajno erekcijo.
In general, pregnant mothers received ritonavir after the first three months of pregnancy at a lower dose (booster) along with other protease inhibitors.
Na splošno so nosečnice dobivale ritonavir po prvih treh mesecih nosečnosti v manjšem (spodbujevalnem) odmerku skupaj z drugimi zaviralci proteaz.
The extent of increase in AUC and Cmax depends on the timing of ritonavir administration.
Obseg povečanja AUC in Cmax je odvisen od časa uporabe ritonavirja.
If you are affected do not drive or use machinery.
Če se vam to zgodi, ne upravljajte vozil in strojev.
Food slightly decreases the bioavailability of the ritonavir tablet.
Hrana nekoliko zmanjša biološko uporabnost tablet ritonavirja.
Dizziness is a known undesirable effect that should be taken into account when driving or using machinery.
Omotica je znan neželeni učinek, ki ga je treba upoštevati, kadar naj bi bolnik vozil oz. upravljal s stroji.
Contraindicated when used for the treatment of pulmonary arterial hypertension (PAH) only.
Kontraindiciran je le, kadar se uporablja za zdravljenje pljučne arterijske hipertenzije (PAH).
(μg•h/ml) t1/2 (h)
(μg•uro/ml) t1/2 (ure)
The effect of ritonavir on rifampicin is not known.
Vpliv ritonavirja na rifampcin ni znan.
When ritonavir is used as a pharmacokinetic enhancer at the 100 mg and 200 mg level it cannot be assumed that the following warnings and precautions will also apply.
Če je ritonavir uporabljen kot farmakokinetični stopnjevalec v odmerkih 100 mg in 200 mg, ni mogoče domnevati, da prav tako veljajo naslednja opozorila in previdnostni ukrepi.
Patients with chronic diarrhoea or malabsorption
Bolniki s kronično drisko ali malabsorpcijo
This medicinal product contains 87.75 mg sodium per tablet, equivalent to 4.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
To zdravilo vsebuje 87,75 mg natrija na tableto, kar ustreza 4,4 % priporočenega največjega dnevnega vnosa s strani Svetovne zdravstvene organizacije (WHO), ki je 2 g natrija za odrasle.
In some cases fatalities have been observed.
Opisanih je bilo nekaj smrtnih primerov.
1 Based on parallel group comparison.
Na podlagi primerjave vzporednih skupin.
S-Warfarin R-Warfarin
Varfarin S-varfarin R-varfarin
However, the AUC of the M-2 metabolite was approximately 3% of the AUC of parent compound.
Vendar je AUC presnovka M-2 le približno 3 % AUC matične učinkovine.
Ritonavir Mylan is used by children 2 years of age or older, adolescents and adults who are infected with HIV, the virus which causes AIDS.
Zdravilo Ritonavir Mylan se uporablja pri otrocih, starih 2 leti ali več, mladostnikih in odraslih, ki so okuženi s HIV, virusom, ki povzroča AIDS.
Long term carcinogenicity studies of ritonavir in mice and rats revealed tumourigenic potential specific for these species, but are regarded as of no relevance for humans.
Dolgotrajne raziskave kancerogenosti ritonavirja na miših in podganah so odkrile tumorogeni potencial, specifičen za ti živalski vrsti, ki pa velja za nepomembnega pri ljudeh.
There may be additional information in those leaflets about situations when ritonavir should be avoided.
V teh navodilih so morda dodatne informacije o okoliščinah, v katerih ne smete jemati ritonavirja.
If you have any further questions about Ritonavir Mylan (ritonavir) or the other medicines prescribed, please ask your doctor or pharmacist.
Če imate dodatna vprašanja o zdravilu Ritonavir Mylan (ritonavirju) ali drugih predpisanih zdravilih, se posvetujte z zdravnikom ali s farmacevtom.
If you are currently taking any of these medicines, ask your doctor about switching to a different medicine while you are taking Ritonavir Mylan.
Če trenutno jemljete katero od teh zdravil, se z zdravnikom pogovorite o zamenjavi s kakšnim drugačnim zdravilom, medtem ko uporabljate zdravilo Ritonavir Mylan.
Do not take Ritonavir Mylan if you are allergic to ritonavir or any of the other ingredients of this medicine (see section 6).
Ne jemljite zdravila Ritonavir Mylan če ste alergični na ritonavir ali katerokoli sestavino tega zdravila (glejte poglavje 6).
Kidney (renal) disease, since your doctor may need to check the dose of your other medicines (such as protease inhibitors).
bolezen ledvic, ker bo zdravnik morda moral preveriti odmerek vaših drugih zdravil (npr. zaviralcev proteaz).
Dose adjustment should be considered based on the patient's clinical response to methadone therapy.
Odmerek je treba prilagoditi glede na bolnikov klinični odziv na zdravljenje z metadonom.
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1242/001 30 film-coated tablets EU/1/17/1242/002 90 film-coated tablets EU/1/17/1242/003 100 film-coated tablets
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/17/1242/001 30 filmsko obloženih tablet EU/1/17/1242/002 90 filmsko obloženih tablet EU/1/17/1242/003 100 filmsko obloženih tablet
Dose alterations should not be necessary.
Spreminjanje odmerka praviloma ni potrebno.
Ritonavir did not appear to increase the chance of developing birth defects compared to the general population.
Glede na izkušnje ritonavir ni povečal možnosti za pojav prirojenih hib v primerjavi s splošno populacijo.
The maximum daily dose of this product is equivalent to 53% of the WHO recommended maximum daily intake for sodium.
Največji dnevni odmerek tega zdravila ustreza 53 % priporočenega največjega dnevnega vnosa za natrij s strani Svetovne zdravstvene organizacije (WHO).
So it is important that you carefully read the side effects section of the leaflets that are provided with these other medicines.
Zato je pomembno, da natančno preberete poglavje o neželenih učinkih v navodilih, priloženih tem drugim zdravilom.
• serious allergic reaction (anaphylaxis) • high levels of sugar in the blood
- resna alergijska reakcija (anafilaksija), - visoka koncentracija sladkorja v krvi.
The most frequently used nucleosides in this study were zidovudine, stavudine, didanosine and zalcitabine.
Najpogosteje uporabljani nukleozidi v tej študiji so bili zidovudin, stavudin, didanozin in zalcitabin.
The increases of plasma levels of buprenorphine and its active metabolite did not lead to clinically significant pharmacodynamic changes in a population of opioid tolerant patients.
Višja koncentracija buprenorfina in njegovega aktivnega presnovka v plazmi ni povzročila klinično pomembnih farmakodinamičnih sprememb v populaciji bolnikov s toleranco za opioide.
No clinically significant differences in AUC or Cmax were noted between males and females.
Med ženskami in moškimi niso ugotovili klinično pomembnih razlik v AUC ali Cmax.
The safety and efficacy of ritonavir in children aged below 2 years has not been established.
Varnost in učinkovitost ritonavirja pri otrocih, mlajših od 2 let ni bila ugotovljena.
Limited published data reports that ritonavir is present in human milk.
Dojenje Omejeni objavljeni podatki poročajo, da je ritonavir prisoten v materinem mleku.
Sulfamethoxazole/Trimethoprim2
Sulfametoksazol/Trimetoprim2
Maraviroc may be given with ritonavir to increase the maraviroc exposure.
Maravirok je mogoče uporabiti z ritonavirjem, da bi dosegli večjo izpostavljenost maraviroku.
You may need additional medicine to help your blood clot (factor VIII), in order to control any bleeding.
Morda boste za obvladanje krvavitev potrebovali dodatno zdravilo za strjevanje krvi (faktor VIII).
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
The AUC of the metabolite prednisolone increased by 37 and 28% after 4 and 14 days ritonavir, respectively.
AUC presnovka prednizolona se je povečala za 37 % po 4 dneh in za 28 % po 14 dneh sočasnega jemanja z ritonavirjem.
After ritonavir use for 10 days, no inhibitory effect of ritonavir was observed.
Po 10-dnevni uporabi ritonavirja niso opazili nobenega zaviralnega učinka ritonavirja.
Dasatinib, nilotinib, vincristine, vinblastine
Dasatinib, nilotinib , vinkristin, vinblastin
If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Če opazite kakšne znake okužbe ali druge simptome, kot so mišična šibkost, šibkost, ki se začenja v dlaneh in stopalih in se premika proti trupu, močno bitje srca (palpitacije), tresavica (tremor) ali hiperaktivnost, nemudoma obvestite vašega zdravnika, da vas bo ustrezno zdravil.
Ritonavir concentrations in this study were highly variable and somewhat lower than those obtained in adults receiving 600 mg (approximately 330 mg/m2) twice daily.
Koncentracije ritonavirja so bile v tej študiji zelo spremenljive in nekoliko nižje kot pri odraslih, ki so dobivali 600 mg (približno 330 mg/m2) dvakrat na dan.
The use of higher ritonavir doses might alter the safety profile of the combination and therefore is not recommended.
Uporaba večjih odmerkov ritonavirja lahko spremeni varnostne značilnosti kombinacije, zato ni priporočljiva.
Post-marketing cases have been reported indicating a potential interaction between ritonavir containing products and levothyroxine.
V obdobju trženja so poročali o primerih, ki kažejo na potencialno interakcijo med zdravili, ki vsebujejo ritonavir, in levotiroksinom.
If the benefit is considered to outweigh the risk and ritonavir must be used, reduce the ibrutinib dose to 140 mg and monitor patient closely for toxicity.
Če korist odtehta tveganje in je treba ritonavir uporabiti, zmanjšajte odmerek ibrutiniba na 140 mg in pozorno spremljate bolnika za toksičnost.
For a description of the mechanisms and potential mechanisms contributing to the interaction profile of the PIs, see section 4.5.
Za opis mehanizmov in možnih mehanizmov, ki prispevajo k medsebojnemu delovanju zaviralcev proteaz, glejte poglavje 4.5.
Taking Ritonavir Mylan as recommended should give you the best chance of delaying resistance to the medicines.
Jemanje zdravila Ritonavir Mylan v skladu s priporočili vam zagotavlja najboljšo možnost za odložitev odpornosti proti zdravilom.
SPECIAL STORAGE CONDITIONS Do not store above 30C.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30°C.
Trough concentrations of ritonavir decrease over time, possibly due to enzyme induction, but appeared to stabilise by the end of 2 weeks.
Minimalne koncentracije ritonavirja v stanju dinamičnega ravnovesja se sčasoma zmanjšajo, morda zaradi indukcije encimov, a se ob koncu 2. tedna stabilizirajo.
Paediatric populations The safety profile of ritonavir in children 2 years of age and older is similar to that seen in adults.
Pediatrična populacija Varnostni profil ritonavirja pri otrocih, starejših od 2 let, je podoben varnostnemu profilu pri odraslih.
Ritonavir Mylan film-coated tablets are available in plastic bottles with screw caps containing 30, 90 or 100 tablets and in multipacks of 90 tablets comprising 3 bottles, each containing 30 tablets.
Filmsko obložene tablete Ritonavir Mylan so na voljo v plastenkah z navojnim pokrovčkom, ki vsebujejo 30, 90 ali 100 tablet in v skupnem pakiranju po 90 tablet, ki je sestavljeno iz treh plastenk, od katerih vsaka vsebuje 30 tablet.
People with liver disease or hepatitis may have worsening of liver disease.
Bolnikom z boleznijo jeter ali hepatitisom se bolezen jeter lahko poslabša.
Events noted as having frequency not known were identified via post-marketing surveillance.
Učinke, ki imajo navedeno pogostnost "neznana", so ugotovili med spremljanjem po začetku trženja zdravila.