natgillin/translations-raw huggingface dataset:
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label bottle 10 and 30 ml
Z nalepko označiti stekleničke po 10 in 30 ml
30 ml: amber glass bottle (type III) with polypropylene child resistant closure, polyethylene insert and amber polypropylene dosing syringe.
30 ml: rjava steklena steklenička (tip III) s polipropilensko, za otroke varno zaporko, polietilenskim zamaškom in rumeno rjavo polipropilensko odmerno brizgalko.
10 ml: amber glass bottle (type III) with polyethylene child resistant closure, polyethylene insert and amber polypropylene dosing syringe.
10 ml: rjava steklena steklenička (tip III) s polietilensko, za otroke varno zaporko, polietilenskim zamaškom in rumeno rjavo polipropilensko odmerno brizgalko.
30 ml presentation: amber glass bottle (type III) with polypropylene child resistant closure, polyethylene insert and an amber polypropylene dosing syringe.
30 ml različica: rjava steklena steklenička (tip III) s polipropilensko, za otroke varno zaporko, polietilenskim zamaškom in rumeno rjavo polipropilensko odmerno brizgalko.
Excipient: Sodium benzoate
Pomožna (e) snov (i) Natrijev benzoat
10 ml presentation: amber glass bottle (type III) with polyethylene child resistant closure, polyethylene insert and clear polypropylene dosing syringe.
10 ml različica: rjava steklena steklenička (tip III) s polietilensko, za otroke varno zaporko, polietilenskim zamaškom in dvema prozornima polipropilenskima odmernima brizgalkama.
10 ml presentation: amber glass bottle (type III) with polyethylene child resistant closure, polyethylene insert and an amber polypropylenedosing syringe.
10 ml različica: rjava steklena steklenička (tip III) s polietilensko, za otroke varno zaporko, polietilenskim zamaškom in priloženima dvema prozornima polipropilenskima brizgalkama.
Glycerol
4.11 Karenca
1 Article 29(4) of Directive 2001/83/EC, as amended.
1 Člen 29(4) of Direktive 2001/83/ES, kakor je bila spremenjena.
The Reference Member State was Czech Republic and the Concerned Member States were Austria, Denmark, Germany, Estonia, Greece, France, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Sweden, Slovenia, Slovak Republic and the United Kingdom.
Referenčna država članica je bila Češka republika, zadevne države članice pa so bile Avstrija, Danska, Nemčija, Estonija, Grčija, Francija, Madžarska, Italija, Latvija, Litva, Nizozemska, Norveška, Poljska, Portugalska, Švedska, Slovenija, Slovaška republika in Združeno kraljestvo.
The Rapporteur was Dr Ondrej Slanar and Co-Rapporteur was Dr Matthew Thatcher.
Poročevalec je bil dr. Ondrej Slanar, soporočevalec pa dr. Matthew Thatcher.
The final opinion was converted into a Decision by the European Commission on 22 November 2007.
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 22. novembra 2007.
The Mutual Recognition Procedure started on 21 September 2006.
Postopek medsebojnega priznavanja se je začel 21. septembra 2006.
Czech Republic referred the reasons for disagreement to the EMEA on 30 March 2007.
Češka republika je agenciji EMEA posredovala razloge za nesoglasje dne 30. marca 2007.
A positive opinion was adopted by consensus on 20 September
Pozitivno mnenje je bilo soglasno sprejeto dne 20. septembra 2007.
Significant differences have been identified with regard to the benefit/risk ratio of the product.
V zvezi z razmerjem med koristmi in tveganji zdravila so bile ugotovljene znatne razlike.
The Marketing Authorisation Holder provided written explanations on 20 July 2007.
Imetnik dovoljenja za promet z zdravilom je podal pisna pojasnila 20. julija 2007.
The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, Povzetek glavnih značilnosti zdravila pa v Dodatku III.
This refers to two indications (treatment of locally advanced prostatic carcinoma without metastases, for which surgical castration or other type of medical intervention is not indicated or unacceptable; and as monotherapy in early treatment or as an adjunct to treatment with radiotherapy or radical prostatectomy in patients with prostatic carcinoma (T3-T4, any Stage N, M0) and this was considered to be of serious public health concern.
Te se nanašajo na dve indikaciji (zdravljenje lokalno napredovalega karcinoma prostate brez metastaz, pri katerem kirurška kastracija ali druga vrsta zdravstvenega posega ni indicirana ali sprejemljiva, ter kot monoterapija pri zgodnjem zdravljenju ali kot dopolnilo k zdravljenju z obsevanjem ali radikalno prostatektomijo pri bolnikih s karcinomom prostate (T3-T4, katerikoli stadij N, M0)) in predstavljajo resen zadržek glede javnega zdravja.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Bicaluplex and associated names International Non-Proprietary Name (INN): bicalutamide
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29(4)1 ZA Bicaluplex in z njim povezana imena Mednarodno nelastniško ime (INN): bikalutamid
During their September 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Bicaluplex and associated names, that the objections raised by Germany should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Med svojim zasedanjem septembra 2007 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med koristmi in tveganji za zdravilo Bicaluplex in z njim povezana imena ugodno, ter da ugovori, ki jih je podala Nemčija, ne bi smeli preprečiti podelitve dovoljenja za promet z zdravilom, ter da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodilo za uporabo referenčne države članice dopolniti.
Bicaluplex and associated names, 150 mg, film-coated tablet, is an oral anti-androgen used in the management of prostate cancer.
Bicaluplex in z njim povezana imena, 150 mg, filmsko obložene tablete, je peroralni antiandrogen, ki se uporablja za zdravljenje raka na prostati.
Ingers Industrials Solutions s.r.o submitted applications for mutual recognition of Bicaluplex and associated names, 150 mg, film-coated tablet on the basis of the marketing authorisation granted by Czech Republic on 30 November 2005.
Podjetje Ingers Industrials Solutions s.r.o je predložilo vloge za medsebojno priznavanje zdravila Bicaluplex in z njim povezanih imen, 150 mg, filmsko obložene tablete na osnovi dovoljenja za promet z zdravilom, ki ga je odobrila Češka republika dne 30. novembra 2005.
Pack size bottle (HDPE) 30 tablets bottle (HDPE) 90 (3 x 30) tablets
Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja filmsko obložena tableta peroralna uporaba plastenka (HDPE) 30 tablet filmsko obložena tableta peroralna uporaba plastenka (HDPE) 90 (3 x 30) tablet
Route of Administration
Številka (EU) dovoljenja za promet
• a more frequent need to pass water, even at night.
• pogostejša potreba po odvajanju vode, celo ponoči.
03410 Saint Victor France
03410 Saint Victor Francija
Tell your doctor in particular, if you take:
Še zlasti povejte svojemu zdravniku, če jemljete:
The absolute bioavailability is approximately 32%.
Absolutna biološka uporabnost je približno 32%.
It does not distribute into blood cells.
Ne prehaja v krvne celice.
Do not give this medicine to children and adolescents below 18 years since there is no relevant indication for this age group.
Tega zdravila ne dajajte otrokom in mladostnikom, mlajšim od 18 let, ker v tej starostni skupini ni ustrezne indikacije.
This makes it easier for you to pass water and relieves your symptoms.
S tem olajša odvajanje vode in ublaži vaše simptome.
• Fainting/ Loss of consciousness
• omedlevica/izguba zavesti
• Difficulties in getting or keeping an erection
• težave pri doseganju in ohranjanju erekcije
This change is clinically not relevant and no dose adjustment is required.
Ta sprememba klinično ni pomembna in prilagoditev odmerka ni potrebna.
The expiry date refers to the last day of that month.
Rok uporabnosti zdravila se izteèe na zadnji dan navedenega meseca.
Food decreases Cmax by approximately 30%, increases tmax by approximately 1 hour and has little effect on AUC.
Hrana zniža Cmax za približno 30%, podaljša tmax za približno 1 uro in ima le majhen vpliv na AUC.
* p < 0.001 vs Placebo; ° p = 0.002 vs Placebo
* p < 0,001 v primerjavi s placebom; p = 0,002 v primerjavi s placebom
Take the capsule always with food, preferably at the same time every day.
Kapsulo vedno vzemite s hrano, najbolje vsak dan ob istem času.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke !
The capsule should be taken with food, preferably at the same time every day.
Kapsulo je treba vzeti s hrano, najbolje vsak dan ob istem času.
If this occurs, make sure you sit or lie down straight away until the symptoms have disappeared and inform your doctor as soon as possible (see also section “Driving and using machines”).
Če pride do tega, takoj sedite ali lezite, dokler simptomi ne izginejo in čimprej obvestite svojega zdravnika (glejte poglavje »Vpliv na sposobnost upravljanja vozil in strojev«).
The observed effect was reversible.
Opaženi učinek je bil reverzibilen.
Contact your doctor immediately if you notice any of the following allergic reactions: swelling of the face or throat, difficulty in breathing, feeling faint, itchy skin or hives since the consequences could become serious.
Takoj se posvetujte z zdravnikom, če opazite katere od naslednjih alergijskih reakcij: oteklost obraza ali žrela, težave z dihanjem, omotičnost, srbeča koža ali koprivnica, saj lahko njihove posledice postanejo resne.
• a feeling of not completely emptying the bladder,
• občutek, da mehur ni popolnoma izpraznjen
Baseline value (± SD)
Izhodiščna vrednost ( ± SD)
Packs of 10, 20, 30, 50, 90, 100 capsules.
Pakiranja po 10, 20, 30, 50, 90, 100 kapsul.
In total, 1,581 patients have received silodosin at a dose of 8 mg once daily, including 961 patients exposed for at least 6 months and 384 patients exposed for 1 year.
Skupno je 1.581 bolnikov prejemalo silodozin v odmerku 8 mg enkrat na dan, vključno z 961 bolniki, ki so bili zdravilu izpostavljeni najmanj 6 mesecev in 384 bolniki, ki so bili zdravilu izpostavljeni 1 leto.
It is reversible within a few days upon discontinuation of treatment (see section 4.4).
Učinek je reverzibilen v nekaj dneh po prekinitvi zdravljenja (glejte poglavje 4.4).
Do not use this medicine if you notice that is damaged or shows signs of tampering.
Ne uporabljajte tega zdravila, če opazite, da je pakiranje poškodovano ali kaže znake nepooblaščenega odpiranja.
The possible side effects are listed below:
Spodaj so navedeni možni neželeni učinki:
Minimal pharmacodynamic interactions have been observed between silodosin and maximum doses of sildenafil or tadalafil.
Minimalne farmakodinamske interakcije so opazili med silodozinom in največjimi odmerki sildenafila ali tadalafila.
1 - adverse reactions from spontaneous reporting in the worldwide post-marketing experience (frequencies calculated from events reported in Phase I-IV clinical trials and non-interventional studies).
1 - neželeni učinki iz spontanih poročil iz globalnih izkušenj po začetku trženja (pogostnosti so izračunane iz dogodkov, o katerih so poročali iz kliničnih preskušanj Faze I-IV in neintervencijskih študij).
• Decreased sexual drive
• zmanjšana želja po spolnosti
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Datum prve odobritve: Datum zadnjega podaljšanja:
In vitro data indicate that silodosin does not have the potential to inhibit or induce cytochrome P450 enzyme systems.
In vitro podatki kažejo, da silodozin nima potenciala za zaviranje ali vzpodbujanje citokrom P450 encimskih sistemov.
Silodosin Placebo
silodozin placebo
Positive orthostatic tests were only slightly more common during co-administration; however, no symptomatic orthostasis or dizziness occurred.
Pozitivni ortostatski testi so bili ob sočasni uporabi le nekoliko bolj pogosti, vendar ni prišlo do simptomatske ortostaze ali omotičnosti.
Before starting treatment, the patient should be informed that this effect may occur, temporarily affecting male fertility.
Pred pričetkom zdravljenja je treba bolnika opozoriti, da lahko pride do tega učinka, ki začasno lahko prizadene moško plodnost.
Consequently, the concomitant use of other α-adrenoreceptor antagonists is not recommended.
Zaradi tega sočasna uporaba drugih antagonistov α-adrenergičnih receptorjev ni priporočljiva.
The terminal half-life of parent drug and its glucuronide is approximately 11 hours and 18 hours, respectively.
Končna razpolovna doba izhodiščne spojine in njenega glukuronida znaša približno 11 oziroma 18 ur.
If you do feel weak or dizzy, make sure you sit or lie down straight away until the symptoms have disappeared.
Če občutite šibkost ali omotico, takoj sedite ali lezite, dokler simptomi ne izginejo.
Difference (95% CI) vs placebo
Razlika (95% CI) v primerjavi s placebom
• difficulty in starting to pass water,
• težaven začetek odvajanja vode
The specialist can take appropriate precautions with respect to medicine and surgical techniques to be used.
Zdravnik specialist bo tako z ozirom na zdravilo in uporabljene kirurške tehnike lahko izpeljal posebne previdnostne ukrepe.
Exposure to silodosin and its main metabolites does not change significantly with age, even in subjects of age over 75 years.
Izpostavitev silodozinu in njegovim glavnim presnovkom se celo pri bolnikih, ki so starejši od 75 let, s starostjo bistveno ne spreminja.
It has been demonstrated in vitro that the α1A:α1B binding ratio of silodosin (162:1) is extremely high.
In vitro je bilo dokazano, da je α1A:α1B vezavno razmerje silodozina (162:1)
This may temporarily affect male fertility.
Ta učinek lahko začasno prizadene moško plodnost.
However, a reduction in blood pressure can occur in individual patients, leading in rare cases to syncope.
Vendar pa se pri posameznih bolnikih lahko pojavi znižanje krvnega tlaka, ki v redkih primerih lahko vodi do sinkope (omedlevice).
• If you have problems with your kidneys, please ask your doctor for advice.
• Če imate težave z ledvicami, prosite za nasvet svojega zdravnika.
Patients taking PDE-5 inhibitors concomitantly with silodosin should be monitored for possible adverse reactions.
Bolnike, ki jemljejo zaviralce PDE-5 sočasno s silodozinom, je treba zaradi možnih neželenih učinkov nadzorovati.
At the first signs of orthostatic hypotension (such as postural dizziness), the patient should sit or lie down until the symptoms have disappeared.
Ob prvih znakih ortostatske hipotenzije (kot je posturalna omotičnost) naj bolnik sede ali leže, dokler simptomi ne izginejo.
The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing silodosin in all subsets of the paediatric population in BPH (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje silodozin, za vse podskupine pediatrične populacije z BHP (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Obstructive symptoms
Obstrukcijski simptomi
Silodosin has a volume of distribution of 0.81 L/kg and is 96.6% bound to plasma proteins.
Silodozin ima volumen porazdelitve 0,81 l/kg, vezava na beljakovine plazme je 96,6%.
ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET
Do not drive or operate machines if you feel faint, dizzy, drowsy or have blurred vision.
Ne vozite avtomobila in ne upravljajte strojev, če občutite omedlevico, omotico, zaspanost ali če imate motnje vida.
Since only limited experience exists in patients with moderate renal impairment (n = 35), a lower starting dose of 4 mg is recommended.
Ker so izkušnje pri bolnikih z zmerno okvaro delovanja ledvic le omejene (n = 35), je priporočljiv nižji začetni odmerek 4 mg.
Concomitant use with potent CYP3A4 inhibitors (such as ketoconazole, itraconazole, ritonavir or cyclosporine) is not recommended.
Sočasna uporaba z močnimi zaviralci CYP3A4 (kot so ketokonazol, itrakonazol, ritonavir ali ciklosporin) ni priporočljiva.
Blockade of these α1A-adrenoreceptors causes smooth muscle in these tissues to relax, thus decreasing bladder outlet resistance, without affecting detrusor smooth muscle contractility.
Blokada α1A adrenergičnih receptorjev povzroči sprostitev gladkih mišic v teh tkivih, s čimer se zmanjša izpustni odpor mehurja, ne da bi vplivala na krčljivost gladkih mišic detruzorja.
In the clinical study program, many patients were on concomitant antihypertensive therapy (mostly agents acting on the renin-angiotensin system, beta-blockers, calcium antagonists and diuretics) without experiencing an increase in the incidence of orthostatic hypotension.
V kliničnem študijskem programu so se številni bolniki sočasno zdravili z antihipertenzivi (večinoma z učinkovinami, ki delujejo na sistem renin-angiotenzin, beta-blokatorji, kalcijevimi antagonisti in diuretiki), ne da bi prišlo do porasta pojavnosti ortostatske hipotenzije.
Effects in animals (affecting the thyroid gland in rodents) were observed only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to clinical use.
Učinke na živalih (na žlezi ščitnici pri glodalcih) so opazili samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
Silodosin is also a substrate for P-glycoprotein.
Silodozin je tudi substrat za P-glikoprotein.
If you have moderate kidney problems, your doctor may prescribe a different dose.
Če imate zmerne težave z delovanjem ledvic, vam bo zdravnik morda predpisal drugačen odmerek.
Data observed in the Intent-to-treat populations of each study are shown below:
Prikazani so podatki za populacijo vseh vključenih bolnikov, za vse študije:
Results from this study should be interpreted with caution, since enrolled patients had normal biochemistry values, indicating normal metabolic function, and they were classified as having moderate liver impairment based on ascites and hepatic encephalopathy.
Rezultate te študije je treba interpretirati previdno, saj so bile vrednosti biokemijskih preiskav pri vključenih bolnikih normalne, kar kaže na normalno delovanje presnove, kot bolnike z zmerno okvarjenim delovanjem jeter pa so jih opredelili na podlagi ascitesa in protokavalne encefalopatije.
If you are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če načrtujete otroka, se pred začetkom jemanja tega zdravila posvetujte z zdravnikom ali farmacevtom.
Patients should be informed about the possible occurrence of symptoms related to postural hypotension (such as dizziness) and should be cautioned about driving or operating machines until they know how silodosin will affect them.
Vseeno je treba bolnike opozoriti na možne simptome, povezane s posturalno hipotenzijo (kot je omotičnost) in na potrebno previdnost pri vožnji ali upravljanju strojev, dokler ne ugotovijo, kako bo silodozin vplival nanje.
Silodosin Recordati has minor or moderate influence on the ability to drive and use machines.
Zdravilo Silodosin Recordati ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
Titanium dioxide (E171) Yellow iron oxide (E172) (4 mg capsules only)
Ovojnica kapsule želatina titanov dioksid (E171) rumeni železov oksid (E172) (samo 4 mg kapsula)
Irritative symptoms
Iritacijski simptomi
Silodosin has a substantially lower affinity for the α1B-adrenoreceptors that are primarily located in the cardiovascular system.
Silodozin ima znatno manjšo afinitieto za α1B adrenergične receptorje, ki se prvenstveno nahajajo v srčno-žilnem sistemu.
By blocking these receptors, it causes smooth muscle in these tissues to relax.
Z blokado teh receptorjev povzroči sprostitev gladkih mišic v teh tkivih.
In male rats, decreased fertility was observed from exposures which were approximately twice the exposure at the maximum recommended human dose.
Pri podganjih samčkih so od izpostavitve, ki je približno dvakrat presegala najvišji priporočeni odmerek za človeka, opazili zmanjšano plodnost.
Exposure to the main metabolites, silodosin glucuronide and KMD3293, was also increased.
Povečana je bila tudi izpostavitev glavnima presnovkoma, glukuronidni konjugat silodozina in KMD-3293.
Approximately half of the patients reported an improvement in the most bothersome symptoms complained at baseline by the patients (i.e. nocturia, frequency, decreased stream, urgency, terminal dribbling and incomplete emptying), as assessed by the ICS-male questionnaire.
Približno polovica bolnikov je poročala o izboljšanju najbolj nadležnih simptomov, nad katerimi so se bolniki pritoževali ob izhodišču (tj. nokturija, pogostnost, manjši curek, nuja, končno kapljanje in nepopolna izpraznitev), kot je bilo ocenjeno z vprašalnikom za moške Mednarodnega združenja za inkontinenco (ICS, International Continence Society).
This medicine contains less than 1 mmoL sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na kapsulo, kar v bistvu pomeni ‘brez natrija'.
Silodosin Recordati is available in packs containing 10, 20, 30, 50, 90, 100 capsules.
Zdravilo Silodosin Recordati je na voljo v pakiranjih po 10, 20, 30, 50, 90, 100 kapsul.
This causes an improvement of both storage (irritative) and voiding (obstructive) symptoms (Lower urinary tract symptoms, LUTS) associated with benign prostatic hyperplasia.
To povzroči izboljšanje tako iritacijskih kot tudi obstrukcijskih simptomov (neprijetnih simptomov mokrenja; LUTS - Lower urinary tract symptoms), povezanih z benigno hiperplazijo prostate.
What Silodosin Recordati is and what it is used for What you need to know before you take Silodosin Recordati How to take Silodosin Recordati Possible side effects
Kaj je zdravilo Silodosin Recordati in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Silodosin Recordati Kako jemati zdravilo Silodosin Recordati Možni neželeni učinki
If it is almost time for the next dose, skip the dose you missed.
Če se že bliža čas, ko bi morali vzeti naslednji odmerek, izpuščeni odmerek izpustite.
An in vitro study with Caco-2 cells showed that silodosin is a substrate for P-glycoprotein.
In vitro študija s Caco-2 celicami je pokazala, da je silodozin substrat P-glikoproteina.
Digital rectal examination and, when necessary, determination of prostate specific antigen (PSA) should be performed before treatment and at regular intervals afterwards.
Pred zdravljenjem in nato v rednih intervalih je treba opraviti digitalni pregled rektuma in po potrebi določiti za prostato specifični antigen (PSA).
Within each frequency grouping the observed adverse reactions are presented in order of decreasing seriousness.
V razvrstitvah pogostnosti so opaženi neželeni učinki navedeni po padajoči resnosti.