natgillin/translations-raw huggingface dataset:
- Changes in personality and behaviour such as confusion, delirium or loss of consciousness, seizures (fits), headache, nausea / vomiting, stiff neck, extreme sensitivity to bright light, fever, rash (anywhere on the body).
- spremembami osebnosti in vedenja, kot so zmedenost, delirij ali izguba zavesti, napadi (krči), glavobol, slabost/bruhanje, trd vrat, pretirana občutljivost na močno svetlobo, zvišana telesna temperatura, izpuščaj (kjer koli na telesu).
Initiating treatment with TYSABRI after alemtuzumab is generally not recommended.
Uvedbe zdravljenja z zdravilom TYSABRI po alemtuzumabu na splošno ni priporočljivo.
Within this analysis, a limited subset of patients with data available prior to treatment (158 of the 621 patients) demonstrated a reduction in ARR from 1.466 (95% CI 1.337, 1.604) prior to treatment to 0.110 (95% CI 0.094, 0.128).
Znotraj te analize je omejena podskupina bolnikov s podatki, ki so bili na voljo pred zdravljenjem (158 od 621 bolnikov), pokazala zmanjšanje ARR z 1,466 (95-% IZ: 1,337; 1,604) pred zdravljenjem na 0,110 (95-% IZ: 0,094; 0,128).
A post-marketing meta-analysis was conducted using data from 621 paediatric MS patients treated with TYSABRI (median age 17 years, range was 7-18 years, 91% aged ≥14 years).
Opravili so metaanalizo obdobja trženja zdravila, za katero so uporabili podatke 621 pediatričnih bolnikov z MS, zdravljenih z zdravilom TYSABRI (mediana starost 17 let, razpon je bil 7-18 let, 91 % jih je bilo starih ≥14 let).
If further deterioration occurs during steroid taper and this is judged to be due to continuing or new inflammatory reactions a further course of higher dose steroids may be necessary.
Če se med postopnim zmanjševanjem odmerka steroidov pojavi nadaljnje poslabšanje, ki naj bi bilo posledica dolgotrajne ali nove vnetne reakcije, bodo morda še naprej potrebni višji odmerki steroidov.
You will also find this information in the Patient Alert Card you have been given by your doctor.
To informacijo najdete tudi na opozorilni kartici za bolnika, ki vam jo je dal vaš zdravnik.
• If you have been treated for more than 2 years and you have a lower level of JCV antibodies in your blood.
• če se zdravite dlje kot 2 leti in imate nižje ravni protiteles proti virusu JC v krvi.
TYSABRI is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups:
Zdravilo TYSABRI je indicirano kot terapija, ki spreminja potek bolezni pri odraslih z zelo aktivno recidivno remitentno multiplo sklerozo, za sledeči skupini bolnikov:
For those with a lower risk of PML, your doctor may repeat the test regularly to check if anything has changed if:
Zdravnik lahko teste pri bolnikih, pri katerih je tveganje za PML manjše, redno ponavlja, da ugotovi, ali se je kaj spremenilo, če:
In order to improve traceability of biological medicinal products, the product name (Tysabri) and batch number of the administered product should be clearly recorded.
Za izboljšanje sledljivosti bioloških zdravil je treba jasno zabeležiti ime zdravila (Tysabri) in številko serije uporabljenega zdravila.
• Reminder to show the card to patients and caregivers and provides a list of symptoms that may be associated with the development of PML
• Navodilo, da je treba kartico pokazati partnerjem in skrbnikom, skupaj s seznamom simptomov, ki so lahko povezani s pojavom PML.
• Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
• bolniki s hitro razvijajočo se hudo recidivno remitentno multiplo sklerozo, ki se kaže z 2 ali več recidivi prizadetosti v enem letu ter z 1 ali več lezijami, vidnimi z gadolinijem pri MRS možganov ali znatnim povečanjem površine lezij T2 v primerjavi s predhodnim nedavnim
However, if you experience dizziness, a common side effect, then you should not drive or use machines.
Če se pojavi omotica, ki je pogost neželeni učinek, ne smete voziti ali upravljati strojev.
MRI (0-2 years) Median % change in T2hyperintense lesion volume
MRS (0-2 leti) Mediana % sprememba v obsegu hiperintenzivne lezije T2 (mm3)
− A patient alert card including a core text agreed by the CHMP
− opozorilno kartico za bolnika, vključno z osrednjim besedilom, ki ga je potrdil Odbor za zdravila za uporabo v humani medicini (CHMP).
The patients were randomised with a 2:1 ratio to receive TYSABRI 300 mg (n = 627) or placebo (n = 315) every 4 weeks for up to 30 infusions.
Bolnike so randomizirali v razmerju 2 : 1 za dajanje zdravila TYSABRI 300 mg (n = 627) ali placeba (n = 315) vsake 4 tedne do 30 infuzij.
If you have been treated with alemtuzumab, a thorough evaluation and discussion with your doctor is required to decide if a switch to TYSABRI is appropriate for you.
Če ste se zdravili z alemtuzumabom, bosta za odločitev o tem, ali je za vas prehod na zdravilo TYSABRI primeren, potrebna temeljita ocena in pogovor z zdravnikom.
If herpes encephalitis or meningitis occurs, the medicinal product should be discontinued, and appropriate treatment for herpes encephalitis or meningitis should be administered.
Če pride do herpetičnega encefalitisa ali meningitisa, je treba zdravljenje z zdravilom prekiniti in začeti ustrezno zdravljenje herpetičnega encefalitisa ali meningitisa.
Adverse reactions reported with natalizumab with an incidence of 0.5% greater than reported with placebo are shown below.
Neželeni učinki zdravila, o katerih so poročali pri natalizumabu z 0,5 % višjo incidenco, kot je bila poročana pri placebu, so prikazani spodaj.
• Confirmation of patient understanding of the risks of PML and that they have received a copy of the form and a patient alert card
• potrditev, da bolniki razumejo tveganje PML in so prejeli kopijo obrazca in opozorilno kartico za bolnika,
Short courses of corticosteroids can be used in combination with TYSABRI.
Kratkoročno dajanje kortikosteroidov se lahko uporablja v kombinaciji z zdravilom TYSABRI.
The decision to suspend TYSABRI at any stage may be based on the initial clinical presentation, MRI findings, the evolution of symptoms or signs and/or the response to corticosteroid treatment.
Odločitev o prekinitvi zdravljenja z zdravilom TYSABRI v kateri koli fazi lahko temelji na začetni klinični sliki, ugotovitvah na podlagi slikanja z magnetno resonanco, razvoju simptomov ali znakov in/ali odzivu na zdravljenje s kortikosteroidi.
If you have any further questions on TYSABRI, ask your doctor.
Če imate dodatna vprašanja o uporabi zdravila TYSABRI, se posvetujte z zdravnikom.
No recommendation on a posology can be made.
Priporočil o odmerjanju ni mogoče dati.
Based on how patients treated with TYSABRI are currently monitored at national level, the Marketing Authorisation Holder (MAH) shall discuss and agree with the National Competent Authorities measures to enhance further this monitoring (e.g. registries, post-marketing surveillance studies) as appropriate.
Glede na trenutno spremljanje bolnikov na nacionalni ravni, ki se zdravijo z zdravilom TYSABRI, se mora imetnik dovoljenja za promet z zdravilom dogovoriti in uskladiti s pristojnimi nacionalnimi organi glede ukrepov za nadaljnje povečanje tega spremljanja (npr. registri in študije v obdobju trženja zdravila), kot je primerno.
All changes in haematological variables returned to pre-treatment values, usually within 16 weeks of last dose of the medicinal product and the changes were not associated with clinical symptoms.
Vse spremenjene vrednosti hematoloških spremenljivk so se vrnile na raven pred zdravljenjem, običajno 16 tednov po zadnjem odmerku zdravila.
Some patients may have been exposed to immunosuppressive medicinal products (e.g. mitoxantrone, cyclophosphamide, azathioprine).
Nekateri bolniki so bili morda zdravljeni z imunosupresivi (npr. mitoksantron, ciklofosfamid, azatioprin).
Disease exacerbations or infusion related events may indicate the development of antibodies against natalizumab.
Poslabšanje bolezni ali z infuzijo povezani dogodki lahko kažejo na razvoj protiteles proti natalizumabu.
Clinical neurologic deterioration in patients with PML and/or JCV GCN may be caused by JCVmediated destruction of CNS tissue, or upon restoration of immune function, by an intracerebral immune inflammatory reaction known as immune reconstitution inflammatory syndrome (IRIS).
Do kliničnega nevrološkega poslabšanja pri bolnikih s PML in/ali JCV GCN lahko pride zaradi uničenja tkiva osrednjega živčevja (CNS) zaradi JCV oziroma ob imunski obnovi zaradi intracerebralne vnetne imunske reakcije, znane kot vnetni sindrom imunske obnove (IRIS).
These medicines cannot be used with TYSABRI (see Using other medicines, below).
Ta zdravila se ne smejo uporabljati z zdravilom TYSABRI (glejte Druga zdravila in zdravilo TYSABRI, spodaj).
Severe sequelae can occur including coma and death.
Nastanejo lahko hude posledice, vključno s komo in smrtjo.
Patients treated with TYSABRI must be given the patient alert card and be informed about the risks of the medicinal product (see also package leaflet).
Bolnikom, ki se zdravijo z zdravilom TYSABRI, je treba dati opozorilno kartico za bolnika in jih informirati o tveganjih v zvezi z zdravilom (glejte tudi Navodilo za uporabo).
• Patient details, signature and date
• podatki o bolniku, podpis in datum,
Current pharmacokinetic/pharmacodynamic statistical modelling and simulation indicate that the risk of MS disease activity for patients switching to longer dosing intervals may be higher for patients with body weight >80kg or those with dosing intervals ≥7 weeks.
Trenutno farmakokinetično/farmakodinamično statistično modeliranje in simulacija kažeta, da je tveganje za aktivno multiplo sklerozo pri bolnikih, ki preidejo na daljše intervale odmerjanja, lahko večje pri bolnikih s telesno maso > 80 kg ali tistih, ki imajo intervale odmerjanja ≥ 7 tednov.
In patients treated with TYSABRI, IRIS has occurred within days to several weeks after TYSABRI removal by plasma exchange (PLEX) or immunoabsorption (IA).
Pri bolnikih, ki so jih zdravili z zdravilom TYSABRI, se je IRIS pojavil v nekaj dneh do nekaj tednih po tem, ko je bilo zdravilo TYSABRI odstranjeno zaradi zamenjave plazme (PLEX) ali imunoabsorpcije (IA).
• Confirmation that the doctor has discussed the risks of PML and the risk of IRIS if treatment is discontinued following suspicion of PML
• potrditev da se je zdravnik z bolnikom pogovoril o tveganju PML ter tveganju IRIS, če se zdravljenje prekine zaradi suma na PML,
What TYSABRI is and what it is used for
Kaj je zdravilo TYSABRI in za kaj ga uporabljamo
TYSABRI is contraindicated in combination with other DMTs (see section 4.3).
Zdravilo TYSABRI je kontraindicirano v kombinaciji z drugimi DMT (glejte poglavje 4.3).
Care should be taken with patients who have previously received immunosuppressants to allow sufficient time for immune function recovery to occur.
Pri bolnikih, ki so predhodno prejemali imunosupresive, je treba biti previden in zagotoviti dovolj časa za ponovno vzpostavitev funkcije imunskega sistema.
In a few patients who use TYSABRI, over time the body's natural defence may stop TYSABRI from working properly (the body develops antibodies to TYSABRI).
Pri nekaterih bolnikih, ki se zdravijo z zdravilom TYSABRI, lahko naravni obrambni mehanizem telesa sčasoma prepreči pravilno delovanje zdravila TYSABRI (telo razvije protitelesa na zdravilo
• Reminder not to start Tysabri if there is a serious problem with their immune system
• Opomnik, da se zdravljenja z zdravilom Tysabri ne sme uvesti v primeru resnih težav z imunskim sistemom.
An accelerated elimination procedure as defined in the teriflunomide Summary of Product Characteristics is recommended or alternatively washout period should not be shorter than 3.5 months.
Priporočljiva je uporaba pospešenega postopka izločanja, opredeljenega v povzetku glavnih značilnosti zdravila za teriflunomid, ali pa vmesno obdobje brez zdravljenja ne sme biti krajše od 3,5 meseca.
The following steroid regimens have been reported for the treatment of IRIS in the literature:
Literatura navaja naslednje režime zdravljenja IRIS s steroidi:
No studies have been performed to evaluate the efficacy and safety of TYSABRI when switching patients from DMTs with an immunosuppressant effect.
Študij za oceno učinkovitosti in varnosti zdravila TYSABRI pri prehajanju bolnikov z DMT z imunosupresivnim učinkom niso opravili.
Currently available evidence suggests that the risk of PML is low at an index equal to or below 0.9 and increases substantially above 1.5 for patients who have been on treatment with TYSABRI for longer than 2 years.
Trenutno razpoložljivi dokazi nakazujejo, da je tveganje za PML nizko, če je indeks enak ali nižji od 0,9, vendar se znatno poveča nad 1,5 pri bolnikih, ki so se več kot dve leti zdravili z zdravilom TYSABRI.
The treatment continuation form should contain the elements of the treatment initiation form and, in addition, a statement that the risks of PML increase with duration of treatment and that treatment beyond 24 months carries additional risk.
Obrazec za nadaljevanje zdravljenja mora vsebovati elemente obrazca za uvedbo zdravljenja, poleg tega pa še navedbo, da tveganje PML narašča s trajanjem zdravljenja ter da zdravljenje, ki traja dlje kot 24 mesecev, predstavlja še dodatno tveganje.
• Present the results of the TOUCH analysis which showed clinically and statistically significant reduction in PML risk in patients who are treated with EID (dosing interval 6 weeks) compared to Standard interval dosing (dosing interval 4 weeks).
• Predstavitev rezultatov analize TOUCH, ki je pokazala klinično in statistično pomembno zmanjšanje tveganja za PML pri bolnikih, ki so se zdravili s PIO (šesttedenskim intervalom odmerjanja), v primerjavi z odmerjanjem s standardnim intervalom (štiritedenskim intervalom odmerjanja).
• Details of the patient, treating doctor and date Tysabri was started
• Podrobnosti o bolniku in lečečem zdravniku ter datum uvedbe zdravila Tysabri.
However, given that dizziness has been commonly reported, patients who experience this adverse reaction should be advised not to drive or use machines until it has resolved.
Ker pa se pogosto pojavi omotica, je treba bolnikom, ki doživijo neželene učinke, svetovati, naj ne vozijo ali upravljajo strojev, dokler ta neželeni učinek ne mine.
In clinical trials, herpes infections (Varicella-Zoster virus, Herpes-simplex virus) occurred slightly more frequently in natalizumab-treated patients than in placebo-treated patients.
V kliničnih preskušanjih so bile okužbe s herpesom (virus varicella zoster, virus herpes simplex) pri bolnikih, zdravljenih z natalizumabom nekoliko bolj pogoste kot pri bolnikih, zdravljenih s placebom.
• Information that atypical/opportunistic infections, in particular PML, may occur with TYSABRI and include: o Opportunistic infections (other than PML):
• Informacije, da se lahko pri uporabi zdravila TYSABRI pojavijo atipične/oportunistične okužbe, zlasti PML, vključujejo: o Oportunistične okužbe (razen progresivne multifokalne levkoencefalopatije - PML):
The efficacy of TYSABRI when administered with EID has not been established, and therefore the benefit/risk balance of EID is unknown (see section 4.4).
Učinkovitost zdravila TYSABRI pri uporabi s PIO ni bila ugotovljena, zato je razmerje med koristmi in tveganji PIO neznano (glejte poglavje 4.4).
Patients can switch directly from beta interferon or glatiramer acetate to TYSABRI providing there are no signs of relevant treatment-related abnormalities e.g. neutropenia and, lymphopenia.
Bolniki lahko direktno preidejo z interferona beta ali glatiramer acetata na zdravilo TYSABRI, če ne kažejo znakov pomembnih bolezenskih sprememb, povezanih z zdravljenjem, npr. nevtropenije in limfopenije.
In placebo-controlled trials in 1,617 MS patients treated with natalizumab for up to 2 years (placebo: 1,135), adverse events leading to discontinuation of therapy occurred in 5.8% of patients treated with natalizumab (placebo: 4.8%).
V s placebom kontroliranih preskušanjih pri 1.617 obolelih za MS, zdravljenih z natalizumabom do 2 leti (placebo: 1.135) je prišlo do neželenih učinkov, zaradi katerih je bilo zdravljenje prekinjeno, pri 5,8 % bolnikov, zdravljenih z natalizumabom (placebo: 4,8 %).
Cases of PML have been reported from clinical trials, post-marketing observational studies and postmarketing passive surveillance.
O primerih PML so poročali iz kliničnih preskušanj in iz opazovalnih študij ter pasivnega opazovanja v obdobju trženja zdravila.
After dilution, immediate use is recommended.
Priporoča se, da razredčeno raztopino takoj uporabite.
Use of TYSABRI has been associated with an increased risk of PML, an opportunistic infection caused by JC virus, which may be fatal or result in severe disability.
Z jemanjem zdravila TYSABRI je povezano povečanje tveganja za PML, oportunistično okužbo, ki jo povzroča JCV, ki lahko povzroči smrt ali hudo prizadetost.
• That the aim of the treatment initiation form is to provide patients with information on PML
• da je namen obrazca za uvedbo zdravljenja posredovati bolnikom informacije o PML in IRIS,
Efficacy has been modelled for patients who switch to longer dosing after ≥1 year of approved TYSABRI dosing and who did not experience a relapse in the year prior to switching.
Učinkovitost temelji na bolnikih, ki so prešli na daljše intervale odmerjanja po ≥ 1 letu odobrenega odmerjanja zdravila TYSABRI in pri katerih v letu pred prehodom na daljše intervale odmerjanja ni prišlo do recidiva.
o Patients, their partners and care givers are advised of symptoms that may be indicative of early PML and the need for counseling on the need to be vigilant for these symptoms while on TYSABRI treatment, and also for approximately 6 months after the last dose of TYSABRI (PML has also been reported up to 6 months following the last dose of TYSABRI in patients who did not have findings suggestive of PML at the time of discontinuation).
o Bolnike, njihove partnerje in skrbnike je treba seznaniti s simptomi, ki lahko kažejo na zgodnji stadij PML, in jih opozoriti na potrebo po pozornem spremljanju morebitnega pojava teh simptomov med zdravljenjem z zdravilom TYSABRI ter še približno šest mesecev po zadnjem odmerku zdravila TYSABRI (pri bolnikih, ki niso imeli znakov, ki bi ob času prekinitve zdravljenja kazali na PML, so o PML poročali še do šest mesecev po zadnjem odmerku zdravila TYSABRI).
Contents of the pack and other information What TYSABRI contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo TYSABRI
The pharmacokinetics of natalizumab in patients with renal or hepatic insufficiency has not been studied.
Farmakokinetike natalizumaba pri bolnikih z ledvično ali jetrno insuficienco niso raziskovali.
In a pre-specified, retrospective analysis of US anti-JCV antibody positive TYSABRI patients (TOUCH registry), the risk of PML was compared between patients treated with the approved dosing interval and patients treated with extended interval dosing as identified in the last 18 months of exposure (EID, average dosing intervals of approximately 6 weeks).
V vnaprej opredeljeni, retrospektivni analizi bolnikov iz ZDA, ki so pozitivni na protitelesa proti JCV in ki so bili zdravljeni z zdravilom TYSABRI (register TOUCH), so primerjali tveganje za PML pri bolnikih, zdravljenih z odobrenim intervalom odmerjanja, in bolnikih, zdravljenih s podaljšanim intervalom odmerjanja, kot je bilo ugotovljeno v obdobju zadnjih 18 mesecev izpostavljenosti (PIO, povprečni interval odmerjanja je bil približno 6 tednov).
Anti-JCV antibody prevalence in the EU was reported as ranging from 48.8% to 69.5% in the EU in a cross sectional study of MS patients irrespective of treatment.
V EU so v presečni študiji bolnikov z MS ne glede na način zdravljenja poročali o prevalenci protiteles proti JCV v razponu od 48,8 % do 69,5
• Information on PML and IRIS including the risk of developing PML during TYSABRI
• informacije o PML in IRIS, vključno s tveganjem za razvoj PML med zdravljenjem z zdravilom
ARN has been observed in patients being administered TYSABRI and can be potentially blinding.
ARN so ugotavljali pri bolnikih, zdravljenih z zdravilom TYSABRI, in lahko povzroči slepoto.
In general, anti-JCV antibody prevalence did not appear to be affected by prior immunosuppressant use, prior exposure to TYSABRI, or duration of TYSABRI exposure.
JCV večinoma niso vplivali predhodna uporaba imunosupresivov, predhodna izpostavljenost zdravilu TYSABRI ali trajanje izpostavljenosti zdravilu TYSABRI.
o Confirmation that TYSABRI should be permanently discontinued if PML is confirmed.
o Potrditev trajne ukinitve zdravljenja z zdravilom TYSABRI, če je potrjena PML.
• A reminder of where to report side effects
• Opomnik o naslovu za poročanje neželenih učinkov.
Keep the leaflet and Alert Card with you during treatment and for six months after the last dose of TYSABRI, since side effects may occur even after you have stopped treatment.
Opozorilno kartico za bolnika shranite med zdravljenjem in šest mesecev po zadnjem odmerku zdravila TYSABRI, ker se lahko neželeni učinki pojavijo celo po končanem zdravljenju.
No data are available in MS patients regarding concomitant exposure with immunosuppressant medication.
Za MS bolnike ni podatkov v zvezi s sočasno izpostavljenostjo zdravilom, ki zavirajo imunski odziv.
In addition to this leaflet you will be given a Patient Alert Card, which contains important safety information that you need to know before you are given TYSABRI (pronounced tie-SA-bree) and during treatment with TYSABRI.
Poleg teh navodil boste prejeli tudi opozorilno kartico za bolnika, ki vsebuje pomembne informacije v zvezi z varnostjo, za katere morate vedeti, preden začnete z zdravljenjem z zdravilom TYSABRI
No cases of PML were identified in the meta-analysis, however, PML has been reported in natalizumab treated paediatric patients in the post-marketing setting.
V metaanalizi niso ugotovili nobenega primera PML, vendar so o PML poročali pri pediatričnih bolnikih, zdravljenih z natalizumabom, v obdobju trženja zdravila.
No studies on the effects on the ability to drive and use machines have been performed with TYSABRI.
Študij vpliva na sposobnost vožnje in upravljanja strojev za zdravilo TYSABRI niso izvedli.
Although JC viral load in the CSF might be expected to decline in the setting of IRIS, it is also possible that due to the breakdown of the blood brain barrier (BBB) and release of JCV from cells lysed during IRIS, it can be increased.
Čeprav naj bi se ob pojavu IRIS v CSF virusno breme JC po pričakovanjih zmanjšalo, se lahko kljub vsemu poveča zaradi razgradnje hematoencefalne pregrade (BBB) in sproščanja JCV iz celic, liziranih med IRIS.
TYSABRI contains the active substance (natalizumab).
Zdravilo TYSABRI vsebuje učinkovino (natalizumab).
15 ml concentrate in a vial (type I glass) with a stopper (chlorobutyl rubber) and a seal (aluminium) with a flip-off cap.
15 ml koncentrat v viali (steklo vrste I) s klorobutilnim gumijastim zamaškom in aluminijastim zapiralom z dvižno zaporko.
What you need to know before you use TYSABRI
Kaj morate vedeti, preden boste uporabili zdravilo TYSABRI
If not used immediately, the diluted solution must be stored at 2˚C - 8˚C and infused within 8 hours of dilution.
Razredčeno raztopino, ki je ne porabite takoj, morate shraniti pri temperaturi med 2 ˚C in 8 ˚C in infundirati v roku 8 ur po razredčitvi.
• Present data from PK/PD/efficacy modelling from the RESTORE study which indicates that risk of return of MS disease activity more likely with increased body weight (>80kg) or longer dosing intervals (>7 weeks).
• Trenutni podatki modeliranja FK/FD ter modeliranja učinkovitosti na podlagi študije RESTORE kažejo, da je tveganje za ponovitev MS bolj verjetno v primeru povečane telesne mase (> 80 kg) ali daljših intervalov odmerjanja (> 7 tednov).
• If you do not have antibodies to the JC virus in your blood OR
• nimate protiteles proti virusu JC v krvi ALI
Side effects are listed below by how commonly they have been reported in clinical trials:
V nadaljevanju so po pogostnosti našteti neželeni učinki, o katerih so poročali v kliničnih preskušanjih: