natgillin/translations-raw huggingface dataset:
Any part-used tablets should be returned to the blister pack and then to the original carton to keep them out of the reach of children.
Vse delno uporabljene tablete je treba vrniti v pretisni omot, nato pa v originalno embalažo, da se hranijo zunaj dosega otrok.
What is Isemid and what is it used for?
Kaj je zdravilo Isemid in za kaj se uporablja?
Why is Isemid authorised in the EU?
Zakaj je zdravilo Isemid odobreno v EU?
Congestive heart failure is a condition when the heart cannot pump enough blood around the body.
Kongestivno srčno popuščanje je stanje, pri katerem telo ne more črpati dovolj krvi po telesu.
This can lead to exercise intolerance (inability to carry out physical activity), difficulty breathing and fluid retention.
To lahko povzroči intoleranco za telesno dejavnost (nezmožnost za fizične aktivnosti), težave z dihanjem in zastajanje vode v telesu.
Isemid (torasemide) EMA/790616/2018
Isemid (torasemid) EMA/15628/2019
The main measure of effectiveness was a reduction in scores for lung fluid and cough (both are signs of congestive heart failure) after 14 days of treatment and no worsening of difficulty in breathing or exercise intolerance scores.
Glavno merilo učinkovitosti je bilo zmanjšanje števila primerov tekočine v pljučih in kašlja (oba sta znamenje kongestivnega srčnega popuščanja) po 14 dneh zdravljenja in brez poslabšanja težav pri dihanju ali pri oceni intolerance za telesno dejavnost.
What benefits of Isemid have been shown in studies?
Kakšne koristi je zdravilo Isemid izkazalo v študijah?
People who are hypersensitive to torasemide, sulfonamides or to any of the other ingredients in Isemid should avoid contact with the medicine.
Osebe, ki so preobčutljive za torasemid, sulfonamide ali katero koli drugo sestavino zdravila Isemid, se morajo izogibati stiku z njim.
What are the risks associated with Isemid?
Kakšna tveganja so povezana z zdravilom Isemid?
In a field study involving 321 dogs with congestive heart failure, treatment with Isemid was compared with another established diuretic medicine, furosemide.
V terenski študiji, ki je zajela 321 psov s kongestivnim srčnim popuščanjem, so zdravljenje z zdravilom Isemid primerjali z drugim uveljavljenim diuretikom, furosemidom.
An overview of Isemid and why it is authorised in the EU
Pregled zdravila Isemid in zakaj je odobreno v EU
This decreases the overall blood volume, reducing the effort needed for the heart to pump blood and thereby improving its function.
S tem se zmanjša skupna krvna prostornina in posledično napor srca, potreben za črpanje krvi, kar izboljša njegovo delovanje.
Isemid is a veterinary medicine used to treat signs related to congestive heart failure in dogs.
Isemid je veterinarsko zdravilo, ki se uporablja za zdravljenje znakov, povezanih s kongestivnim srčnim popuščanjem pri psih.
For more information about using Isemid, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe zdravila Isemid glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
Isemid must not be given in cases of kidney failure, dehydration, a decrease in circulating blood volume or low blood pressure.
Zdravilo Isemid se ne sme dajati v primeru odpovedi ledvic, dehidracije, zmanjšanja prostornine krvi v obtoku ali nizkega krvnega tlaka.
Isemid to be as least as effective as furosemide for the treatment of signs related to congestive heart failure with 74% of dogs in each group being successfully treated.
furosemid za zdravljenje znakov, povezanih s kongestivnim srčnim popuščanjem, saj je bilo uspešno zdravljenih 74 % psov v vsaki skupini.
Isemid is available as tablets and can only be obtained with a prescription.
Zdravilo Isemid je na voljo v obliki tablet, predpisovanje in izdaja zdravila pa je le na recept.
If the product is accidentally swallowed by a person, particularly by a child, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.
Če človek, zlasti otrok, zdravilo nenamerno zaužije, se je treba nemudoma posvetovati z zdravnikom in mu pokazati navodilo za uporabo ali nalepko.
For the full list of side effects and restrictions of Isemid, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Isemid glejte navodilo za uporabo.
Isemid may increase urination, and lead to thirst, gut disturbances, low blood pressure and dehydration if ingested.
Če se zdravilo Isemid zaužije, lahko poveča uriniranje in povzroči žejo, motnje prebavil, nizek krvni tlak in dehidracijo.
If symptoms of allergy occur, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.
Če se na koži pojavijo simptomi alergije, se je treba nemudoma posvetovati z zdravnikom in mu pokazati navodilo za uporabo ali nalepko.
Isemid contains the active substance torasemide.
Zdravilo Isemid vsebuje učinkovino torasemid.
How is Isemid used?
Kako se zdravilo Isemid uporablja?
How does Isemid work?
Kako zdravilo Isemid deluje?
If you notice any of the above symptoms:
Če opazite katerega od naštetih simptomov:
It is usually given into your arm over about 30 minutes.
Po navadi se daje v roko v trajanju približno 30 minut.
Risk of bacterial infections
Tveganje za bakterijske okužbe
Eligible patients were not to have had >3 days of prior antiviral treatment.
Primerni bolniki niso smeli imeti > 3 dni predhodnega protivirusnega zdravljenja.
• confused thinking
• zmedeno razmišljanje,
It is used when other flu treatments are not suitable.
Uporablja se, kadar druga zdravila za gripo niso primerna.
Your dose may be increased or decreased depending on how well you respond to treatment.
Zdravnik vam lahko odmerek poveča ali zmanjša glede na to, kako dobro se odzovete na zdravljenje.
Influenza can be associated with a variety of neurological and behavioural symptoms.
Gripa je lahko povezana z različnimi nevrološkimi in vedenjskimi simptomi.
The initial 5 day treatment course could be extended for up to 5 additional days if clinical symptoms or patient characteristics warranted further treatment.
Uvodnih 5 dni ciklusa zdravljenja je bilo mogoče podaljšati za do 5 dodatnih dni, če so klinični simptomi ali bolnikove značilnosti zahtevali nadaljnje zdravljenje.
• Each vial is for single use only; once the seal has been broken, the remaining volume must be discarded.
• Posamezna viala je le za enkratno uporabo; ko je zapora pretrgana, je treba preostalo količino zavreči.
• if you are allergic to zanamivir or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na zanamivir ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
This means that for scientific reasons it has not been possible to get complete information on this medicine.
To pomeni, da iz znanstvenih razlogov ni bilo mogoče pridobiti vseh podatkov o zdravilu.
Therefore, patients should be closely monitored for behavioural changes and the benefits and risks of continuing treatment should be carefully evaluated for each patient (see section 4.8).
Zato je treba bolnike natančno nadzirati glede vedenjskih sprememb, koristi in tveganja nadaljevanja zdravljenja pa je treba pri vsakem bolniku skrbno oceniti (glejte poglavje 4.8).
➔ Tell a doctor or nurse immediately.
Takoj obvestite zdravnika ali medicinsko sestro.
If your kidneys are not working as well as they should, your doctor will decide on the reduced dose for you.
Če vam ledvice ne delujejo, kot bi morale, se bo zdravnik odločil, kolikšen naj bo vaš zmanjšani odmerek.
Phase III study in patients with complicated influenza
Študija III. faze pri bolnikih z zapleteno gripo
Dectova should be used in accordance with official guidance.
Zdravilo Dectova je treba uporabljati v skladu z uradnimi smernicami.
Contact your doctor or nurse straight away if you notice any of the following serious side effects:
Nemudoma se posvetujte z zdravnikom ali medicinsko sestro, če opazite katerega od naslednjih resnih neželenih učinkov:
Dectova must not be mixed with other medicinal products except those mentioned in section 6.6.
Zdravila Dectova se ne sme mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6.
The primary analysis was performed on the Influenza Positive Population (IPP) comprised of 488 patients.
Primarno analizo so izvedli v populaciji, pozitivni za gripo, ki je obsegala 488 bolnikov.
Date of first authorisation: 26 April 2019
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 26. april 2019
The median patient age was 57 years and 35% (218/615) of patients were ≥65 years, of which 17% (n=103) were 65 to <75; 14% (n=84) were 75 to <85, and 5% (n=31) were ≥85 years of age.
Mediana starost bolnikov je bila 57 let in 35 % (218/615) bolnikov je bilo starih ≥ 65 let, od katerih je bilo 17 % (n = 103) starih 65 do < 75 let, 14 % (n = 84) 75 do < 85 let in 5 % (n = 31) ≥ 85 let.
6 months to < 6 years
6 mesecev do < 6 let
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Patients were stratified at randomisation based on time from onset of symptoms to initiation of treatment (≤4 days and 5 to 6 days).
Bolnike so ob randomizaciji stratificirali glede na čas od pojava simptomov do uvedbe zdravljenja (≤ 4 dni in 5 do 6 dni).
All patients must have their renal function assessed before and regularly during treatment.
Pri vseh bolnikih je treba ledvično funkcijo oceniti pred zdravljenjem in redno med zdravljenjem.
• seeing, hearing or feeling things which are not there
• prividi, prisluhi ali občutenje stvari, ki jih ni,
Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake EXP.
In adults with normal renal function, the elimination half-life is approximately 2-3 hours.
Pri odraslih z normalnim delovanjem ledvic je eliminacijski razpolovni čas približno 2-3 ure.
Serious skin or allergic reactions
Resne kožne ali alergijske reakcije
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2ºC to 8ºC, unless dilution has taken place in controlled and validated aseptic conditions.
Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas ne sme presegati 24 ur na temperaturi od 2 °C do 8 °C, razen če sta priprava/razredčenje opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
Overall, the safety profile in paediatric patients was similar to that observed in adults in the clinical studies.
Varnostni profil pri pediatričnih bolnikih je bil v splošnem podoben, kot so ga opazili v kliničnih študijah pri odraslih.
Dectova is used to treat severe flu (influenza virus infection).
Zdravilo Dectova se uporablja za zdravljenje hude gripe (okužbe z virusom influence).
• Calculate the required dose and volume of Dectova.
• Izračunajte potrebni odmerek in količino zdravila Dectova.
• If refrigerated, the infusion bag should be removed from the refrigerator and brought up to room temperature before use.
• Če je vrečka za infundiranje shranjena v hladilniku, jo je treba pred uporabo vzeti iz hladilnika in ogreti na sobno temperaturo.
The plasma protein binding of zanamivir is very low (less than 10%).
Porazdelitev Vezava zanamivirja na beljakovine v plazmi je zelo majhna (manj kot 10 %).
Any unused solution should be discarded.
Vso neporabljeno raztopino je treba zavreči.
Q3 2025
3. kvartal 2025
Table 7: Pharmacokinetic parameters in paediatric and adult subjects
Preglednica 7: Farmakokinetični parametri pri pediatričnih in odraslih preiskovancih
During treatment with Dectova, changes in behaviour such as confusion and unresponsiveness may occur.
Med zdravljenjem z zdravilom Dectova se lahko pojavijo spremembe vedenja, na primer zmedenost in neodzivnost.
Some people may also have hallucinations (seeing, hearing, or feeling things that are not there) or fits (seizures) which can lead to loss of consciousness.
Nekaterim ljudem se lahko pojavijo halucinacije (prividi, prisluhi ali občutenje stvari, ki jih ni) ali napadi krčev (konvulzije), ki lahko povzročijo izgubo zavesti.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom,
The pharmacokinetics in elderly subjects was similar to young adult subjects.
Starejše osebe Farmakokinetika pri starejših osebah je bila podobna kot pri mladih odraslih.
Zanamivir is eliminated unchanged in urine by glomerular filtration.
Zanamivir se nespremenjen izloča v urinu z glomerularno filtracijo.
The safety and efficacy of Dectova in children aged under 6 months have not been established.
Varnost in učinkovitost zdravila Dectova pri otrocih do 6. meseca starosti nista ugotovljeni.
Dectova has not been shown to reduce the risk of bacterial complications associated with influenza infection.
Ni dokazano, da bi zdravilo Dectova zmanjšalo tveganje za bakterijske zaplete, povezane z okužbo z gripo.
Vials of Dectova are for single use only.
Viale zdravila Dectova so namenjene samo za enkratno uporabo.
Nervous system disorders convulsions depressed level of consciousness not known
Bolezni živčevja konvulzije deprimirana raven zavesti ni znano
The most important serious adverse reaction was hepatocellular injury, observed in two patients (<1%).
Najpomembnejši resni neželeni učinek je bila okvara jetrnih celic, ki je bila opažena pri dveh bolnikih (< 1%).
The amount you are given is based on your age, body weight, and the results of your blood tests (to check how well your kidneys are working).
Količina, ki jo boste dobili, je odvisna od vaše starosti, telesne teže in izvidov preiskav krvi (za preverjanje delovanja ledvic).
• The patient's influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or
• je bolnikov virus influence znano ali domnevno odporen proti drugim zdravilom proti gripi razen zanamivirja in/ali
If any hypersensitivity reaction occurs during infusion of Dectova, the infusion must be stopped immediately and appropriate management should be instituted.
Če se med infundiranjem zdravila Dectova pojavi kakršna koli preobčutljivostna reakcija, je treba infundiranje takoj končati in uvesti ustrezno zdravljenje.
Elderly No dose adjustment is required based on age.
Prilagoditev odmerka glede na starost ni potrebna.
Resistance selection during zanamivir treatment is rare.
Selekcija odpornosti med zdravljenjem z zanamivirjem je redka.
The European Medicines Agency has deferred the obligation to submit the results of studies with Dectova in one or more subsets of the paediatric population in the treatment and prevention of influenza (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Dectova za eno ali več podskupin pediatrične populacije za zdravljenje in preprečevanje gripe (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
• being less alert or not responding to loud sounds or being shaken
• zmanjšana pozornost ali neodzivnost na glasne zvoke ali tresenje
Serious skin and allergic reactions may occur with Dectova, but there isn't enough information to estimate how likely they are.
Med uporabo zdravila Dectova se lahko pojavijo resne kožne in alergijske reakcije, vendar ni na voljo dovolj podatkov za oceno, kako verjetne so.
Symptoms may include skin or throat swelling, difficulty breathing, blistering rash or peeling skin (see also ‘Serious skin or allergic reactions' in section 4).
Med simptomi so lahko otekanje kože ali žrela, težko dihanje, izpuščaj z mehurji ali lupljenje kože (glejte tudi "Resne kožne ali alergijske reakcije" v poglavju 4).
The volume of distribution of zanamivir in adults is approximately 16 litres, which approximates the volume of extracellular water.
Volumen porazdelitve zanamivirja pri odraslih je približno 16 litrov; to je približno enako volumnu zunajcelične vode.
Pharmacokinetic studies in Thai, Chinese and Japanese healthy subjects did not identify any clinically relevant differences in the pharmacokinetics of zanamivir in these populations compared with Caucasians.
Farmakokinetične študije pri zdravih tajskih, kitajskih in japonskih preiskovancih niso pokazale klinično pomembnih razlik v farmakokinetiki zanamivirja v teh populacijah v primerjavi z belci.
The primary endpoint was time to clinical response (TTCR); clinical response was defined as a composite of vital sign stabilisation (temperature, oxygen saturation, respiratory status, heart rate and systolic blood pressure) or hospital discharge.
Primarni opazovani dogodek je bil čas do kliničnega odziva (TTCR - time to clinical response); klinični odziv je bil opredeljen kot sestavljeni dogodek stabilizacije vitalnih znakov (temperatura, saturacija s kisikom, respiratorno stanje, srčna frekvenca in sistolični krvni tlak) ali odpust iz bolnišnice.
6 months - <1 year mg/kg
mesecev - < 1 leto mg/kg
• Other anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient.
• druga protivirusna zdravila za zdravljenje influence (vključno z zanamivirjem za inhaliranje) za konkretnega bolnika niso primerna.
This substitution has no effect on zanamivir; therefore, viruses with the H275Y substitution retain full susceptibility to zanamivir.
Ta substitucija ne vpliva na zanamivir, zato ostanejo virusi s substitucijo H275Y v polni meri občutljivi na zanamivir.
The clinical impact of reduced susceptibility in these viruses is unknown, and the effects of specific substitutions on virus susceptibility to zanamivir may be strain-dependent.
Klinični vpliv zmanjšane občutljivosti pri teh virusih ni znan in učinki specifičnih substitucij na občutljivost virusa za zanamivir so lahko odvisni od seva.
• severe allergic reactions, including features such as itchy rash, swelling of the face, throat or tongue, breathing difficulty, light headedness and vomiting.
• hude alergijske reakcije, vključno s srbečim izpuščajem, otekanjem obraza, žrela ali jezika, težave z dihanjem, omotica in bruhanje.
The H275Y substitution is the most common neuraminidase resistance substitution and is associated with reduced susceptibility to peramivir and oseltamivir.
Substitucija H275Y je najpogostejša substitucija odpornosti proti nevraminidazi in je povezana z manjšo občutljivostjo za peramivir in oseltamivir.
In the rat embryofoetal study, there was an increase in the incidence rates of a variety of minor skeletal and visceral alterations, most of which remained within the background rates of the historical occurrence in the strain studied.
V embrio-fetalni študiji pri podganah so ugotovili povečanje incidenčnih deležev različnih manjših skeletnih in visceralnih sprememb, toda večina jih je ostala v okviru izhodiščnih deležev pojavljanja pri proučevanem sevu v preteklosti.
Side effects where it is not known how likely they are to happen There isn't enough information to estimate how likely these side effects are:
Neželeni učinki, katerih verjetnost ni znana Za oceno tega, kako verjetni so naslednji neželeni učinki, ni dovolj podatkov:
A doctor or nurse will give you Dectova as an infusion (drip) into a vein.
Zdravnik ali medicinska sestra vam bo dal zdravilo Dectova v infuziji (kapalni) v veno.
Resistance in immunocompromised patients
Odpornost pri imunsko oslabelih bolnikih
• The infusion bag should be gently manipulated by hand to ensure it is mixed thoroughly.
• Vrečko za infundiranje je treba obzirno stiskati z rokami, da se vsebina dobro premeša.
The most commonly reported adverse reactions considered possibly or probably related to Dectova are alanine aminotransferase increased (2%), aspartate aminotransferase increased (1%), hepatocellular injury (1%), diarrhoea (1%) and rash (1%).
Najpogosteje poročani neželeni učinki, ki so morda ali verjetno povezani z zdravilom Dectova, so povišana raven alanin-aminotransferaze (2 %), povišana raven aspartat-aminotransferaze (1 %), okvara jetrnih celic (1 %), driska (1 %) in izpuščaj (1 %).
Psychiatric disorders abnormal behaviour hallucinations delirium not known
Psihiatrične motnje nenormalno vedenje halucinacije delirij ni znano
Dectova should not be administered simultaneously with other intravenous medicinal products or prepared in solutions containing glucose or other electrolytes (see section 6.6).
Zdravila Dectova se ne sme uporabljati sočasno z drugimi intravenskimi zdravili, prav tako se ga ne sme pripravljati v raztopinah, ki vsebujejo glukozo ali elektrolite (glejte poglavje 6.6).
Human challenge study
Provokacijska študija pri človeku
• clinical and virological activity of zanamivir compared to placebo in a human influenza challenge study;
• klinične in virološke aktivnosti zanamivirja v primerjavi s placebom v provokacijski študiji gripe pri človeku,
In vitro studies indicate that zanamivir is not an inhibitor or substrate of Breast Cancer Resistant Protein (BCRP), P-glycoprotein, Multidrug And Toxin Extrusion protein (MATE)1, MATE2-K, Organic Anion Transporter (OAT)1, OAT3, Organic Anion Transporting Polypeptide (OATP)1B1, OATP1B3 and Organic Cation Transporter (OCT)2 transporters, nor is it an inhibitor of cytochrome P450 (CYP) enzymes CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4.
Študije in vitro kažejo, da zanamivir ni zaviralec ali substrat BCRP (Breast Cancer Resistant Protein), P-glikoproteina, prenašalcev MATE (Multidrug And Toxin Extrusion protein)1, MATE2-K, OAT (Organic Anion Transporter)1, OAT3, OATP (Organic Anion Transporting Polypeptide)1B1, OATP1B3 ali OCT (Organic Cation Transporter)2 , niti ni zaviralec encimov citokroma P450 (CYP) CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 ali 3A4.
Dectova is administered by intravenous infusion over 30 minutes.
Intravenska uporaba Zdravilo Dectova se daje v 30-minutni intravenski infuziji.
As experience is limited, the use of zanamivir in breast-feeding mothers should be considered only if the possible benefit to the mother is thought to outweigh any possible risk to the child.
Ker je izkušenj malo, je treba o uporabi zanamivirja pri doječih ženskah razmišljati le, če možne koristi za mater domnevno odtehtajo vsa možna tveganja za otroka.
It is unlikely that you will be given too much, but if you think you have been given too much Dectova, tell your doctor or nurse immediately.
Če ste dobili večji odmerek zdravila Dectova, kot bi smeli Ni verjetno, da bi dobili preveč zdravila, toda če menite, da ste dobili preveč zdravila Dectova, o tem nemudoma obvestite zdravnika ali medicinsko sestro.
For patients on intermittent haemodialysis or intermittent peritoneal dialysis, the dose should be given after completion of the dialysis session.
Bolniki na intermitentni hemodializi ali intermitentni peritonealni dializi morajo odmerek dobiti po dokončanem dializiranju.
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR
E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA
Treatment of an overdose should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Specifičnega antidota za zdravljenje prevelikega odmerjanja tega zdravila ni. Zdravljenje prevelikega odmerjanja mora obsegati splošne podporne ukrepe, vključno z nadziranjem vitalnih znakov in opazovanjem bolnikovega kliničnega stanja.
In rats, zanamivir has been shown to be secreted in low amounts into milk.
Pri podganah je dokazano, da se zanamivir v majhni količini izloča v mleko.