natgillin/translations-raw huggingface dataset:
Your doctor will examine you and review your full medical history.
Zdravnik vas bo pregledal in se seznanil z vašo celotno zdravstveno zgodovino.
Each pack contains 1 vial.
Vsako pakiranje vsebuje 1 vialo.
Remove vial from refrigerator just prior to use.
Vialo vzemite iz hladilnika tik pred uporabo.
Proper aseptic technique must be observed.
Upoštevati morate pravilno aseptično tehniko.
18.7 (15.6, NE)
18,7 (15,6, NO)
The median follow-up was approximately 37 months.
Mediani čas spremljanja je bil približno 37 mesecev.
Elderly patients (≥ 75 years)
Starejši bolniki (≥ 75 let)
Each 28-day period is one treatment cycle.
Vsako 28-dnevno obdobje predstavlja en ciklus zdravljenja.
Some of these events have been fatal.
Nekateri od teh dogodkov so bili smrtni.
• Any other major disease for which you were hospitalised or received any medicine.
• Kakršno koli drugo pomembno bolezen, zaradi katere ste se zdravili v bolnišnici ali ste zaradi nje dobivali kakršna koli zdravila.
Most patients will receive treatment for as long as their disease improves or remains stable.
Večina bolnikov bo prejemala zdravljenje tako dolgo, dokler se njihova bolezen ne izboljša ali postane stabilna.
a. Study PX-171-009
a. Študija PX-171-009
Tell your doctor straight away if you get notice any of the following symptoms:
Zdravniku morate takoj povedati, če opazite katerega od naslednjih simptomov:
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 November 2015
Datum prve odobritve: 19. november 2015
The proteasome is a system within the cells that breaks down proteins when they are damaged or no longer needed.
Proteasom je sistem znotraj celic, ki razgrajuje beljakovine, kadar so le-te poškodovane ali niso več potrebne.
Some of these events have been fatal (see section 4.8).
Nekateri od teh dogodkov so bili smrtni (glejte poglavje 4.8).
The elapsed time from reconstitution to administration should not exceed 24 hours.
Čas od rekonstitucije do uporabe ne sme preseči 24 ur.
Oral and/or intravenous hydration should be continued, as needed, in subsequent cycles.
S peroralno in/ali intravensko hidracijo je potrebno v nadaljnjih ciklusih nadaljevati, kot je potrebno.
Recommended action
Priporočeno ukrepanje
In addition and according to the agreed case definition by Mentzer et al., two cases of level 1, one case of level 2 and one case of level 3 were identified.
Poleg tega in v skladu z dogovorjeno opredelitvijo primerov po Mentzerju in drugih, sta bila ugotovljena dva primera 1. stopnje in en primer 2. stopnje ter en primer 3. stopnje.
Dose level reductions are presented in table 4.
Ravni zmanjšanja odmerka so predstavljena v tabeli 4.
Subsequently patients should be treated with caution and remain under close follow-up.
V nadaljevanju je treba bolnike zdraviti previdno in jih natančno spremljati.
This study did not evaluate the benefit/risk ratio in the broader refractory population.
Ta študija ni raziskala razmerja koristi in tveganja v širši populaciji odpornih bolnikov.
There is currently insufficient information to draw conclusions about the safety of doses higher than those evaluated in clinical studies.
Trenutno ni dovolj podatkov za sklepanje o varnosti odmerkov, večjih od tistih, ocenjenih v kliničnih študijah.
• Reduced blood flow to the heart
• zmanjšan dotok krvi v srce,
If not used immediately, in-use storage times and conditions are the responsibility of the user and should not be longer than 24 hours at 2°C - 8°C.
Če ni uporabljeno takoj, so čas in pogoji shranjevanja med uporabo odgovornost uporabnika in čas običajno ne sme presegati 24 ur na temperaturi 2 °C - 8 °C.
• Difficulty sleeping (insomnia)
• težave s spanjem (nespečnost),
Special attention should be paid to patients with moderate and severe hepatic impairment in view of the very limited efficacy and safety data on this population.
Bolnikom z zmerno in hudo okvaro jeter je treba nameniti posebno pozornost glede na zelo maloštevilne podatke o učinkovitosti in varnosti v tej populaciji.
This can indicate you have low numbers of platelets (cells that help the blood to clot)
To lahko pomeni, da imate nizko število krvnih ploščic (celic, ki pomagajo, da se kri strdi).
The dose will be calculated based on your height and weight (body surface area).
Odmerek vam bodo izračunali na podlagi vaše telesne višine in teže (tj. na podlagi telesne površine).
* Frequency is calculated based on data from clinical trials in which most patients used prophylaxis
* Pogostost je izračunana na podlagi podatkov iz kliničnih študij, v katerih je večina bolnikov prejela profilakso
• Ringing in the ears (tinnitus)
• zvenenje v ušesih (tinitus),
The results of study 2011-003 are summarised in table 7.
Rezultati študije 2011-003 so povzeti v tabeli 7.
As this medicine is being given by a doctor or nurse, it is unlikely that you will be given too much.
Zdravilo vam bo dal zdravnik ali medicinska sestra, zato ni zelo verjetno, da bi ga dobili preveč.
Action should be taken to try to minimise all modifiable risk factors (e.g. smoking, hypertension and hyperlipidaemia).
Ukrepati je treba, da bi čim bolj zmanjšali vse dejavnike tveganja, na katere je mogoče vplivati (npr. kajenje, hipertenzija in hiperlipidemija).
Your doctor or nurse will check if you are getting enough fluids.
Zdravnik ali medicinska sestra bosta preverila, da boste dobivali dovolj tekočine.
Based on its pharmacological properties, a risk to the suckling child cannot be excluded.
Na podlagi njegovih farmakoloških značilnosti, tveganja za dojenega otroka ne moremo izključiti.
Read the complete preparation instructions prior to reconstitution.
Pred rekonstituiranjem preberite celotna navodila za pripravo.
If you had these symptoms prior to treatment with carfilzomib, tell your doctor about any change in these symptoms.
Če ste navedene simptome imeli že pred zdravljenjem s karfilzomibom, povejte zdravniku o vsaki morebitni spremembi teh simptomov.
You will be monitored closely during treatment.
Med zdravljenjem vas bo skrbno nadzoroval.
This assessment should optimise the patient's status, with particular attention to blood pressure control and fluid management.
Ocena mora optimizirati bolnikovo stanje, posebno pozornost pa je treba nameniti ureditvi krvnega tlaka in uravnavanju tekočin.
Do not take Kyprolis if you are pregnant, think you may be pregnant or are planning to have a baby.
Ne jemljite zdravila Kyprolis, če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev.
• Serum creatinine equal to or greater than 2 × baseline; or
• Kreatinin v serumu enak ali večji 2-kratni izhodiščni vrednosti; ali
This is to check that you have enough blood cells and your liver and kidneys are working properly.
Tako bodo preverili, da imate dovolj krvnih celic ter da vam jetra in ledvice ustrezno delujejo.
Consequently, as a precautionary measure, breast-feeding is contra-indicated during and for at least 2 days after treatment with Kyprolis.
Posledično, kot previdnostni ukrep, je dojenje kontraindicirano med zdravljenjem in še vsaj 2 dneva po zdravljenju z zdravilom Kyprolis.
Recommended actions and dose modifications are presented in table 3.
Priporočeno ukrepanje in prilagoditve odmerka so prikazani v tabeli 3.
Kd (black) Vd (grey)
Kd (črno) Vd (sivo)
These may all be symptoms of a serious and potentially fatal brain condition known as Progressive Multifocal Leukoencephalopathy (PML).
Vse to so lahko simptomi hude, smrtno nevarne možganske bolezni, imenovane progresivna multifokalna levkoencefalopatija (PML).
The safety of resuming carfilzomib, after HBV reactivation is adequately controlled, is not known.
Varnost ponovne uporabe karfilzomiba, potem ko je ponovna aktivacija HBV ustrezno obvladana, ni znana.
Enrolled subjects were defined as refractory to a therapy if they met any of the following 3 criteria: nonresponsive (< minimal response) to any regimen; progression during any regimen; or progression within 60 days of completion of any regimen.
Zajete preiskovance so opredelili kot odporne proti zdravljenju, če so izpolnjevali katero od naslednjih 3 meril: neodzivni (< minimalni odziv) na katero koli shemo, napredovanje med katero koli shemo ali napredovanje v 60 dneh po končanju katere koli sheme.
Kyprolis is given 2 days in a row each week, for 3 weeks, followed by one week without treatment.
Zdravilo Kyprolis boste dobili 2 dni zapored vsak teden 3 tedne zapored; temu bo sledil en teden brez zdravljenja.
• Increased sweating
• močnejše znojenje,
a. Infusion time is 30 minutes and remains consistent throughout the regimen
a. Čas infundiranja je 30 minut in ostane stalen med celotno shemo
• A general feeling of illness or discomfort
• splošen občutek obolelosti ali nelagodja.
For potential dose-related effects, see section 4.8.
Za možne učinke, povezane z odmerkom, glejte poglavje 4.8.
Hypertension including hypertensive crises
Hipertenzija vključno s hipertenzivnimi krizami
This includes any medicines obtained without a prescription, such as vitamins or herbal remedies.
To velja tudi za vsa zdravila, ki ste jih dobili brez recepta, na primer za vitamine in zeliščne pripravke.
If lenalidomide is taken during pregnancy, a teratogenic effect of lenalidomide in humans is expected.
Če je lenalidomid uporabljen med nosečnostjo, je pri človeku pričakovan njegov teratogeni učinek.
• Women who are breast-feeding (see section 4.6).
• Ženske, ki dojijo (glejte poglavje 4.6).
The marketing authorisation holder shall submit the first PSUR for this product within 6 months following authorisation.
Imetnik dovoljenja za promet z zdravilom mora prvo PSUR za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.
Creatinine clearance was stable over time for the majority of patients.
Pri večini bolnikov je bil očistek kreatinina stabilen skozi čas.
Patients with known risk factors for thromboembolism - including prior thrombosis - should be closely monitored.
Bolnike z znanimi dejavniki tveganja za tromboembolijo - vključno s predhodno trombozo - je treba natančno spremljati.
Dexamethasone should be administered 30 minutes to 4 hours before Kyprolis.
Deksametazon je treba uporabiti od 30 minut do 4 ure pred zdravilom Kyprolis.
If PML is suspected, further administration must be suspended until PML has been excluded by a specialist with appropriate diagnostic testing.
Če obstaja sum na PML, je treba nadaljnjo uporabo začasno prekiniti, dokler strokovnjak ne izključi bolezni PML z ustreznim diagnostičnim testiranjem.
Proportion Surviving without Progression
Delež preživelih brez napredovanja
Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism.
Bolnikom in zdravnikom je treba svetovati, naj bodo pozorni na znake in simptome tromboembolije.
Gently swirl and/or invert the vial slowly for approximately 1 minute, or until complete dissolution.
Vialo previdno vrtite in/ali obračajte približno 1 minuto oziroma dokler se prašek povsem ne raztopi.
These events typically occurred early in the course of Kyprolis therapy (< 5 cycles).
Ti dogodki so se praviloma pojavili zgodaj med zdravljenjem z zdravilom Kyprolis (< 5 ciklusov).
These reactions can occur immediately following or up to 24 hours after administration of Kyprolis.
Te reakcije se lahko pojavijo takoj po uporabi zdravila Kyprolis ali do 24 ur po njegovi uporabi.
If PML is confirmed, carfilzomib must be discontinued.
Če je bolezen PML potrjena, je treba prenehati uporabljati karfilzomib.
These patients may be at greater risk for cardiac complications.
Ti bolniki imajo lahko večje tveganje za zaplete.
If you have ever had hepatitis B infection, treatment with this medicine may cause the hepatitis B infection to become active again.
Če ste kdaj imeli okužbo s hepatitisom B, lahko zdravljenje s tem zdravilom povzroči ponovno aktivacijo okužbe s hepatitisom B.
Kyprolis treatment was administered for a maximum of 18 cycles unless discontinued early for disease progression or unacceptable toxicity.
Zdravilo Kyprolis so za zdravljenje uporabljali največ 18 ciklusov, razen če ni bilo predčasno prekinjeno zaradi napredovanja bolezni ali nesprejemljivih toksičnih učinkov.
Treatment may be continued until disease progression or until unacceptable toxicity occurs.
Zdravljenje se lahko nadaljuje do napredovanja bolezni ali do pojava nesprejemljivih toksičnih učinkov.
Tell your doctor or nurse if you are taking medicines used to prevent pregnancy such as oral contraceptives or other hormonal contraceptives, as these may not be suitable for use with Kyprolis.
Zdravniku ali medicinski sestri morate povedati, če uporabljate zdravila za preprečevanje nosečnosti, kot so kontracepcijske tablete ali drugi hormonski kontraceptivi, ker lahko niso primerni za uporabo skupaj z zdravilom Kyprolis.
Results from both studies show that renal function status had no marked effect on the exposure of carfilzomib following single or repeat-dose administration.
Rezultati obeh študij kažejo, da stanje delovanja ledvic ne vpliva izrazito na izpostavljenost karfilzomibu po uporabi enkratnega in ponavljajočih se odmerkov.
You must read the package leaflet of all medicines that you take in combination with Kyprolis so that you understand the information related to those medicines.
Prebrati morate navodila za uporabo vseh zdravil, ki jih prejemate v kombinaciji z zdravilom Kyprolis, da boste razumeli z njimi povezane informacije.
There are no data from the use of carfilzomib in pregnant women.
Podatkov o uporabi karfilzomiba pri nosečnicah ni.
Appropriate dose modifications based on toxicity should be made (see table 3).
Odmerek je treba ustrezno prilagoditi glede na toksičnost (glejte tabelo 3).
Do not use Kyprolis if you are allergic to carfilzomib or any of the other ingredients of this medicine (listed in section 6).
Zdravila Kyprolis ne smete dobiti, če ste alergični na karfilzomib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The conditions of the Pregnancy Prevention Programme for lenalidomide must be fulfilled for all patients unless there is reliable evidence that the patient does not have child bearing potential.
Pri vseh bolnicah morajo biti izpolnjeni pogoji programa za preprečevanje nosečnosti v zvezi z lenalidomidom, razen če obstajajo zanesljivi dokazi, da bolnica ne more zanositi.
If the hypertension cannot be controlled, the Kyprolis dose should be reduced.
Če hipertenzije ni mogoče obvladati, je treba odmerek zdravila Kyprolis zmanjšati.
• Change in voice or hoarseness
• sprememba glasu ali hripavost,
• Flu-like symptoms (influenza)
• gripi podobni simptomi (gripa),
Patients being treated with Kyprolis should be advised not to drive or operate machines in the event that they experience any of these symptoms.
Bolnikom, zdravljenim z zdravilom Kyprolis, je treba naročiti, naj ne vozijo in ne upravljajo s stroji, če se jim pojavi kateri od teh simptomov.
Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Talidomid je pri človeku znana teratogena učinkovina, ki povzroča hude življenjsko ogrožujoče napake pri rojstvu.
Your doctor or nurse will determine the dose of Kyprolis that you receive.
Zdravnik ali medicinska sestra bo določil(a) odmerek zdravila Kyprolis, ki ga boste dobili.
Number of Subjects at Risk:
Število preiskovancev, izpostavljenih tveganju:
What you need to know before you use Kyprolis
Kaj morate vedeti, preden boste uporabili zdravilo Kyprolis
The results of study PX-171-009 are summarised in table 6 and in figure 1 and figure 2.
Rezultati študije PX-171-009 so povzeti v tabeli 6 ter na sliki 1 in sliki 2.
• Serious infection including infection in the blood (sepsis)
• resne okužbe, vključno z okužbo krvi (sepso),
Chemical and physical in-use stability of reconstituted solutions in the vial, syringe or intravenous bag has been demonstrated for 24 hours at 2°C - 8°C or for 4 hours at 25°C.
Kemična in fizikalna stabilnost med uporabo rekonstituiranih raztopin v viali, brizgi ali intravenski vrečki je dokazana za 24 ur pri 2 °C - 8 °C ali za 4 ure pri 25 °C.
Kyprolis treatment should be supervised by a physician experienced in the use of anti-cancer therapy.
Zdravljenje z zdravilom Kyprolis mora nadzirati zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
Kyprolis will be stored in the pharmacy.
Zdravilo Kyprolis bodo shranjevali v lekarni.
• Liver problems including an increase in liver enzymes in the blood
• težave z jetri, vključno z zvišanjem jetrnih encimov v krvi,
Frequency categories were determined from the crude incidence rate reported for each adverse reaction in a dataset of pooled clinical studies (n = 2,944).
Kategorije pogostnosti so določene na podlagi grobe incidenčne stopnje, poročane za vsak neželeni učinek v kumulativnem naboru podatkov kliničnih študij (n = 2.944).
Electrocardiographic changes
Spremembe na elektrokardiogramu
• Consider restarting the next scheduled treatment at 1 dose level reductiona a. See table 4 for dose level reductions
• Razmislite o ponovnem začetku naslednjega predvidenega zdravljenja z zmanjšanim odmerkom za 1 ravena a. Za ravni zmanjšanja odmerka glejte tabelo 4
An effect of Kyprolis on QT interval cannot be excluded (see section 5.1).
Učinka zdravila Kyprolis na interval QT ne moremo izključiti (glejte poglavje 5.1).
All patients should be screened for HBV before initiation of treatment with carfilzomib.
Vse bolnike je treba pred uvedbo zdravljenja s karfilzomibom pregledati za HBV.
Hydration, fluid and electrolyte monitoring
Hidracija, nadzor tekočine in elektrolitov
Population pharmacokinetic analyses indicate there are no effects of age, gender or race on the pharmacokinetics of carfilzomib.
Populacijske farmakokinetične analize kažejo, da starost, spol ali rasa ne vplivajo na farmakokinetiko karfilzomiba.
Doses of ≥ 15 mg/m2 consistently induced an (≥ 80%) inhibition of the CT-L activity of the proteasome.
Odmerki ≥ 15 mg/m2 so dosledno povzročili (≥ 80 %) zavrtje proteasomske aktivnosti CT-L.
In the event of an overdose, the patient should be monitored, specifically for the adverse reactions to Kyprolis listed in section 4.8.
V primeru prevelikega odmerjanja je treba bolnika spremljati, še posebej za neželene reakcije na zdravilo Kyprolis, navedene v poglavju 4.8.
If you are given too much Kyprolis
Če ste dobili preveč zdravila Kyprolis
Carfilzomib does not inhibit human UGT2B7 but inhibits human UGT1A1 with an IC50 of 5.5 µM.
Karfilzomib ne zavira humanega UGT2B7, vendar pa zavira humani UGT1A1 z IC50 5,5 µM.
Kyprolis will be given to you by a doctor or nurse.
Zdravilo Kyprolis vam bo dal zdravnik ali medicinska sestra.
The risk of cardiac failure is also increased in Asian patients.
Tveganje za srčno popuščanje je večje tudi pri azijskih bolnikih.
25 mg daily a. Infusion time is 10 minutes and remains consistent throughout the regimen
25 mg na dan a. Čas infundiranja je 10 minut in ostane stalen med celotno shemo
This metabolite has no known biological activities.
Ta presnovek nima znanih bioloških aktivnosti.
Fertility studies with carfilzomib have not been conducted.
Študij plodnosti s karfilzomibom niso izvedli.
Tell your doctor right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes.
Zdravniku morate takoj povedati, če opazite poslabšanje utrujenosti ali porumenelost kože ali belih delov oči.
• Allergic reaction to Kyprolis
• alergijska reakcija na zdravilo Kyprolis,
Lenalidomide and dexamethasone administration could continue until progression or unacceptable toxicity.
Uporaba lenalidomida in deksametazona se je lahko nadaljevala do napredovanja ali nesprejemljivih toksičnih učinkov.
Kyprolis vials contain no antimicrobial preservatives and are intended for single use only.
Viale zdravila Kyprolis ne vsebujejo antimikrobnih konzervansov in so namenjene samo za enkratno uporabo.
Reduce or stop dose as appropriate (see section 4.2).
Zmanjšajte odmerek ali prekinite uporabo, kot je ustrezno (glejte poglavje 4.2).
Proportion Surviving
Delež preživelih
What Kyprolis is and what it is used for
Kaj je zdravilo Kyprolis in za kaj ga uporabljamo
Adverse reactions are presented below by system organ class and frequency category (table 5).
Neželeni učinki so prikazani spodaj po organskih sistemih in pogostnosti (tabela 5).
Within each system organ class and frequency category, adverse reactions are presented in order of decreasing seriousness.
Pri vsakem organskem sistemu in v vsaki kategoriji pogostnosti so neželeni učinki navedeni v padajočem zaporedju resnosti.
However, if you are given too much Kyprolis your doctor will monitor you for side effects.
Če bi vseeno dobili preveč zdravila Kyprolis, vas bo zdravnik spremljal glede neželenih učinkov.
Pack size of one vial.
Velikost pakiranja z eno vialo.
Note: Kyprolis infusion times remain unchanged during dose reduction(s) a. If symptoms do not resolve, discontinue Kyprolis treatment
Opomba: Čas infundiranja zdravila Kyprolis se med zmanjšanjem/zmanjšanji odmerka ne spremeni a. Če simptomi ne minejo, prenehajte z zdravljenjem z zdravilom Kyprolis
• Creatinine clearance < 15 mL/min (or creatinine clearance decreases to ≤ 50% of baseline) or need for dialysis (see section 4.4)
• Očistek kreatinina < 15 ml/min (ali zmanjšanje očistka kreatinina na ≤ 50 % izhodiščnega) ali potreba po dializi (glejte poglavje 4.4)
Kyprolis powder for solution for infusion must not be mixed with sodium chloride 9 mg/mL (0.9%) solution for injection.
Zdravila Kyprolis prašek za raztopino za infundiranje se ne sme mešati z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje.
Before starting Kyprolis, and during treatment, you will undergo blood testing.
Pred začetkom zdravljenja z zdravilom Kyprolis in med zdravljenjem vam bodo opravljali preiskave krvi.
Caution should be observed when carfilzomib is combined with medicinal products that are substrates of these enzymes, such as oral contraceptives.
Previdnost je potrebna, če je karfilzomib uporabljen skupaj z zdravili, ki so substrati teh encimov, npr. s peroralnimi kontraceptivi.
For patients with positive HBV serology, prophylaxis with antivirals should be considered.
Pri bolnikih s pozitivno serologijo HBV je treba razmisliti o protivirusni profilaksi.
Caution should be used in the concomitant administration of other agents that may increase the risk of thrombosis (e.g. erythropoietic agents or hormone replacement therapy).
Previdnost je potrebna v primeru sočasne uporabe drugih zdravil, ki lahko povečajo tveganje za trombozo (npr. eritropoetičnih zdravil ali hormonskega nadomestnega zdravljenja).
You may need extra tests to check that your heart, kidneys and liver are working properly.
Morda boste morali opraviti dodatne preiskave za preverjanje pravilnega delovanja srca, ledvic in jeter.
Dosing should be modified based on Kyprolis toxicity.
Odmerjanje je treba prilagoditi glede na toksičnost zdravila Kyprolis.
The European Medicines Agency has waived the obligation to submit the results of studies with Kyprolis in all subsets of the paediatric population in multiple myeloma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Kyprolis za vse podskupine pediatrične populacije pri diseminiranem plazmocitomu (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
As lenalidomide may be used in combination with Kyprolis, particular attention to the lenalidomide pregnancy testing and prevention requirements is needed (see section 4.6).
Ker se lenalidomid lahko uporablja v kombinaciji z zdravilom Kyprolis, je treba posebno pozornost nameniti testiranju nosečnosti in zahtevam za preprečevanje nosečnosti, povezanih z lenalidomidom (glejte poglavje 4.6).
Combination dosing with lenalidomide and dexamethasone did not affect proteasome inhibition.
Kombinirana uporaba z lenalidomidom in deksametazonom ni vplivala na zavrtje proteasomov.
• Infection of the stomach and intestine (gastroenteritis)
• okužba želodca in črevesa (gastroenteritis),