FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no data available on pharmacodynamic properties in children below 18 years of age.
Slovenian: Podatkov o farmakodinamičnih lastnosti pri otrocih, mlajših od 18 let, ni na voljo.
English: Medicines must not be disposed of via wastewater or household waste.
Slovenian: Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: In female rats dosed before mating to gestation day 7, slightly reduced numbers of implantations and viable foetuses were found, but without any dose-response and within the range of historical control data.
Slovenian: Pri podganjih samicah, ki so prejemale zdravilo v obdobju pred parjenjem do 7. dneva brejosti, se je nekoliko zmanjšalo število vsaditev in število zarodkov, sposobnih za preživetje, vendar brez kakršnega koli odziva na odmerek in v skladu z zgodovinskimi kontrolnimi podatki.
English: This section contains information on how to give yourself an injection of Ceplene.
Slovenian: V tem poglavju so navedeni podatki o tem, kako si lahko sami date injekcijo zdravila Ceplene.
English: • Patients who have received an allogenic stem cell transplant.
Slovenian: • Bolniki, pri katerih je bila izvedena transplantacija alogenskih izvornih celic.
English: Plasma drug levels were not predictive of adverse effects, however, and effects did not correlate closely with drug exposure.
Slovenian: Plazemska raven zdravila ne nakazuje neželenih učinkov, učinki pa tudi niso v tesni povezavi z izpostavljenostjo zdravilu.
English: Some of them must not be taken during treatment with Ceplene or may need special precautions:
Slovenian: Nekaterih izmed navedenih zdravil ne smete jemati med zdravljenjem z zdravilom Ceplene ali pa je pri tem potrebna posebna previdnost:
English: During your treatment, you will always use IL-2 AND Ceplene.
Slovenian: Med zdravljenjem boste vedno uporabljali IL-2 IN zdravilo Ceplene.
English: Content of the pack and other information
Slovenian: Vsebina pakiranja in dodatne informacije
English: Treatment should only be resumed after consideration of risk - benefit to the patient.
Slovenian: Zdravljenje nadaljujte le po natančni preučitvi razmerja med tveganjem in koristjo za bolnika.
English: Yearly, simultaneously with submission of Periodic Safety Update reports
Slovenian: Letno, sočasno s predložitvijo rednega posodobljenega poročila o varnosti zdravila
English: Adjust the syringe so that the tip of the needle is slightly above the rubber stopper but still within the solution.
Slovenian: Brizgo namestite tako, da bo vrh igle le malo nad gumijasto zaporko, vendar še vedno v raztopini.
English: Do not use Ceplene
Slovenian: Ne uporabljajte zdravila Ceplene
English: Patients with clinically significant infection requiring the use of antibiotics, antifungals, or antivirals, or who have completed prior anti-infectious therapy within 14 days of starting treatment should be treated with caution unless the use of antibiotics and antivirals were for prophylaxis purposes.
Slovenian: Bolniki s klinično pomembnimi okužbami, ki zahtevajo zdravljenje z antibiotiki, antimikotiki ali protivirusnimi zdravili, ali ki so v obdobju 14 dni pred pričetkom zdravljenja z zdravilom Ceplene zaključili z antiinfektivno terapijo, naj bodo posebej nadzorovani, razen če so bili antibiotiki in protivirusna zdravila uporabljeni v preventivne namene.
English: • Feeling of general discomfort or unease
Slovenian: • občutek nelagodja ali neudobja
English: For your safety it is very important that you are sitting where you can lean back or lie flat when you perform the injections.
Slovenian: Zaradi lastne varnosti se usedite na prostor, kjer se lahko tudi naslonite nazaj ali uležete po injiciranju zdravil.
English: It is not known whether histamine crosses the placenta.
Slovenian: Ni znano, ali histamin prehaja skozi placento.
English: You may choose the inner or outer thighs, arms or stomach.
Slovenian: Izberete lahko notranjo ali zunanjo stran stegen, rok ali trebuh.
English: If you are using a syringe pump you must refer to the instructions provided by the pump manufacturer and the training provided by your doctor or nurse.
Slovenian: Če uporabljate črpalko za brizgo, upoštevajte navodila za uporabo, ki jih je predložil proizvajalec, ter navodila za uporabo, ki vam jih je dal vaš zdravnik ali medicinska sestra.
English: Do not take any additional dose to make up for the forgotten doses.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek zdravila.
English: If you are taking any other medicines mentioned under “Other medicines and Ceplene” or if you are to have an operation or special X-ray investigation requiring an injection, talk to your doctor.
Slovenian: Če jemljete katero koli drugo zdravilo, navedeno v poglavju „Druga zdravila in zdravilo Ceplene“, ali če boste v kratkem operirani ali boste imeli rentgensko preiskavo na način, ki zahteva injiciranje, se o tem pogovorite z zdravnikom.
English: If you notice a severe drop in blood pressure after use of Ceplene, please contact your physician immediately or at least prior to administration of further Ceplene injections.
Slovenian: Če opazite hud padec krvnega tlaka po uporabi zdravila Ceplene, se posvetujte z zdravnikom takoj ali vsaj pred dajanjem nadaljnjih injekcij zdravila Ceplene.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to clinical use.
Slovenian: V predkliničnih študijah so učinke opazili samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
English: If you forget to take Ceplene
Slovenian: Če ste pozabili vzeti zdravilo Ceplene
English: There may be a small amount of solution left in the vial.
Slovenian: V viali bo morda ostalo nekoliko raztopine.
English: It is recommended that dose modifications be addressed early in treatment.
Slovenian: Priporočeno je, da se vprašanje prilagajanja odmerkov razreši na začetku zdravljenja.
English: Since you will be using both IL-2 and Ceplene in a combined treatment, information about both dosages is provided:
Slovenian: Ker boste uporabljali IL-2 in zdravilo Ceplene v kombinaciji, so navedene informacije o odmerjanju obeh zdravil:
English: If you have had one of the following conditions you will be monitored in the hospital during the next treatment days or the next cycles of treatment:
Slovenian: Če ste imeli katero od spodaj navedenih bolezni ali stanj, vas bodo nekaj dni zdravljenja ali v naslednjih ciklih zdravljenja spremljali v bolnišnici:
English: Pick up the sterile syringe.
Slovenian: Primite sterilno brizgo.
English: For the dose recommendations for these grade 1 toxicity events refer to the relevant sections below:
Slovenian: Za priporočila glede določanja odmerkov pri 1. stopnji toksičnih dogodkov glejte ustrezne razdelke, navedene v nadaljevanju:
English: Patients should be provided with capped polypropylene syringes and instructed to extract 0.5 mL of solution into the syringe.
Slovenian: Bolnikom je treba preskrbeti polipropilenske brizge z zamaškom in jim dati navodila za izvlek 0,5 mL raztopine v brizgo.
English: The main enzymes involved in the metabolism of histamine are HNMT (histamine-N-methyltransferase) and DAO (diamine oxidase).
Slovenian: Najpomembnejša encima, vključena v presnavljanje histamina, sta HNMT (histamin-N-metiltransferaza in DAO (diamin oksidaza).
English: Do not use Ceplene after the expiry date which is stated on the carton and vial label.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki na viali.
English: Hold the needle either vertically (90°) or at a 45° angle to the skin and insert it under the skin as far as it will go in one quick motion.
Slovenian: Iglo postavite v navpičen položaj (90°) ali pod kotom 45° stopinj glede na kožo in jo z enim hitrim gibom potisnite pod kožo, kolikor globoko lahko.
English: If you have had an infection within 14 days of starting this treatment which required you to take medicines to treat infections (antibiotics, antifungals or antivirals), your doctor will closely monitor you.
Slovenian: Če ste 14 dni pred začetkom zdravljenja imeli kakšno okužbo, ki je zahtevala zdravljenje z zdravili (antibiotiki, antimikotiki ali protivirusnimi zdravili), vas bo zdravnik posebej pozorno spremljal.
English: This treatment must be prescribed and supervised by a physician with knowledge of acute myeloid leukaemia.
Slovenian: Zdravljenje s tem zdravilom mora predpisati in nadzorovati zdravnik z ustreznim poznavanjem akutne mieloične levkemije.
English: For general information about the dosage and how to use Ceplene and IL-2, please see section 3, “How to use Ceplene”.
Slovenian: Za splošne podatke o odmerjanju in uporabi zdravila Ceplene in IL-2 glejte poglavje 3 „Kako uporabljati zdravilo Ceplene“.
English: Overall systemic exposure of Ceplene was greater in patients versus healthy subjects.
Slovenian: Splošna sistemska izpostavljenost zdravilu Ceplene je bila večja pri bolnikih v primerjavi z zdravimi osebami.
English: Continue with the treatment as prescribed.
Slovenian: Nadaljujte zdravljenje v skladu z navodili.
English: Rapid subcutaneous injection or injection into a vascular space may result in severe hypotension, tachycardia, or syncope.
Slovenian: Hitro subkutano injiciranje ali injiciranje v žilo lahko povzroči hudo hipotenzijo, tahikardijo ali sinkopo.
English: Subsequent injections of Ceplene may be self-administered at home by a patient who demonstrates a good understanding of necessary precautions and who has demonstrated adequate injection skills.
Slovenian: Nadaljnje injiciranje zdravila Ceplene lahko izvaja bolnik sam doma, če ustrezno razume potrebne previdnostne ukrepe in izkazuje zadovoljivo spretnost ravnanja z injekcijo.
English: Always inject IL-2 first.
Slovenian: Vedno najprej injicirajte IL-2.
English: It is used together with low doses of interleukin-2 (IL-2), another medicine which helps the immune system to fight diseases like cancer.
Slovenian: Uporablja se skupaj z majhnim odmerkom interlevkina-2 (IL-2), zdravila, ki prav tako pomaga imunskemu sistemu v boju proti bolezni, kot je rak.
English: Hypotension (low blood pressure) may occur very commonly and may lead to light-headedness and fainting.
Slovenian: Hipotenzija (nizek krvni tlak) se lahko pojavi zelo pogosto in lahko povzroči omotičnost in omedlevico.
English: No carcinogenicity studies have been performed on Ceplene.
Slovenian: Študij kancerogenosti z zdravilom Ceplene niso izvedli.
English: Plasma histamine concentrations were highly variable and were considerably higher in the groups of patients with moderate or severe hepatic impairment (medians 10 and 5 times the normal volunteers respectively).
Slovenian: Plazemske koncentracije histamina so se zelo spreminjale in so bile bistveno višje pri skupinah bolnikov z zmernimi ali hudimi jetrnimi okvarami (mediani sta bili 10- oziroma 5-krat višji kot pri zdravih prostovoljcih).
English: Ceplene and low dose IL-2 have been investigated in other clinical studies at different doses (1 mg histamine dihydrochloride twice a day) and with different dose regimens of low-dose IL-2 and interferon-alfa.
Slovenian: Zdravilo Ceplene in majhne odmerke IL-2 so preučevali tudi v drugih kliničnih študijah z različnimi odmerki (1 mg histaminijevega diklorida dvakrat na dan) in z drugimi režimi odmerjanja z majhnimi odmerki IL-2 in interferonom alfa.
English: • Constipation, swollen stomach, inflamed mouth
Slovenian: • zaprtost, otečen trebuh, vneta usta
English: It has been noted that neuromuscular blocking agents, narcotic analgesics, and various contrast media can induce the release of endogenous histamine; therefore in patients undergoing diagnostic or surgical procedures, the additive effect of Ceplene treatment should be considered prior to the procedure (see section 4.4).
Slovenian: Opaženo je bilo, da lahko zaviralci živčno-mišičnega prenosa, narkotični analgetiki in različna kontrastna sredstva inducirajo sproščanje endogenega histamina, zato je pri bolnikih, napotenih na diagnostične ali kirurške postopke, treba upoštevati dodatni učinek zdravljenja z zdravilom Ceplene pred postopkom (glejte poglavje 4.4).
English: The solution must be clear and colourless.
Slovenian: Raztopina mora biti bistra in brezbarvna.
English: IL-2 16 400 IU/kg followed by 0.5 mL Ceplene.
Slovenian: IL-2 16.400 i.e/kg, čemur sledi 0,5 mL zdravila Ceplene.
English: • Drying-out of the body (dehydration)
Slovenian: • izguba vode iz telesa (dehidracija)
English: Treatment cycles
Slovenian: Cikli zdravljenja
English: To prepare a dose of Ceplene you will need the following: 1 vial of Ceplene solution (0.5 mL) 1 sterile graduated syringe with needle 1 alcohol wipe
Slovenian: Za pripravo odmerka zdravila Ceplene boste potrebovali: 1 vialo raztopine zdravila Ceplene (0,5 mL) 1 sterilno kalibrirano brizgo z iglo 1 alkoholno krpico
English: If you are not sure about how to give yourself the injection or you have any questions, please ask your doctor or nurse for help.
Slovenian: Če niste prepričani o tem, kako si samoinjicirati zdravilo, ali imate kakršna koli vprašanja, se po pomoč obrnite na zdravnika ali medicinsko sestro.
English: The needle must be inserted under the skin, but not into any blood vessels below the skin.
Slovenian: Igla mora biti pod kožo, vendar ne v žili v podkožju.
English: Patient monitoring during subsequent treatment days or cycles should be performed as long as the patient continues to experience significant changes in vital signs during administration of Ceplene.
Slovenian: Spremljanje bolnikov med nadaljnjim zdravljenjem v ciklu ali med naslednjimi cikli naj poteka, dokler se pri bolniku pojavljajo bistvene spremembe v življenjskih znakih med uporabo zdravila Ceplene.
English: Recommended dose
Slovenian: Priporočeni odmerek
English: Animal studies showed reproductive toxicity but only at maternotoxic doses, and did not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Slovenian: Študije na živalih so pokazale reproduktivno toksičnost, vendar le pri uporabi odmerkov, toksičnih za mater, in ne nakazujejo neposrednih škodljivih vplivov na nosečnost, razvoj zarodka/ploda, porod ali postnatalni razvoj (glejte poglavje 5.3).
English: Other medicines and Ceplene
Slovenian: Druga zdravila in zdravilo Ceplene
English: Patients with renal impairment may be more sensitive to the blood pressure lowering effects of Ceplene.
Slovenian: Bolniki z ledvično okvaro so lahko bolj občutljivi na zniževanje krvnega tlaka, ki ga povzroči zdravilo Ceplene.
English: • The other ingredients are water for injections and sodium chloride, and it may also contain sodium hydroxide and/or hydrochloric acid for pH adjustment.
Slovenian: • Druge sestavine zdravila so voda za injekcije in natrijev klorid, zdravilo pa lahko vsebuje tudi natrijev hidroksid in/ali klorovodikovo kislino za uravnavanje pH.
English: Histamine is eliminated by metabolism in kidney, liver and other tissues.
Slovenian: Histamin se iz organizma izloča s presnavljanjem v ledvicah, jetrih in drugih tkivih.
English: • Sensation of spinning (vertigo)
Slovenian: • občutek vrtoglavice (vertigo)
English: Certain medicines used for an operation (for example neuromuscular blocking medicines and narcotic pain-killers) or dyes used for certain Xrays may interfere with this medicine.
Slovenian: Določena zdravila, ki se uporabljajo pri operacijah (na primer zdravila za zaviranje živčno-mišičnega prenosa in narkotična protibolečinska zdravila) ali določena barvila za uporabo pri rentgenskem slikanju, lahko vplivajo na delovanje tega zdravila.
English: 1 Take 1 vial out of the carton.
Slovenian: Iz škatle vzemite 1 vialo.
English: The role of Ceplene is to protect lymphocytes, in particular NK cells and T cells, which are responsible for the immune-mediated destruction of residual leukaemic cells.
Slovenian: Vloga zdravila Ceplene je zaščititi limfocite, zlasti celice ubijalke (NK celice) in T celice, ki so odgovorne za imunsko uničevanje preostalih levkemičnih celic.
English: Slightly pull back the plunger.
Slovenian: Bat potegnite rahlo nazaj.
English: Double check the vial label to make sure you are using the correct medicine.
Slovenian: Ponovno preverite nalepko na viali in se prepričajte, ali uporabljate pravo zdravilo.
English: H2 receptor antagonists with imidazole structures similar to histamine, e.g., cimetidine, systemic steroids and clonidine, must not be used during treatment with Ceplene (see section 4.3).
Slovenian: Antagonistov receptorjev H2 z imidazolnimi strukturami, podobnimi histaminu, na primer cimetidina, sistemskih steroidov in klonidina, med zdravljenjem z zdravilom Ceplene ne smemo uporabljati (glejte poglavje 4.3).
English: Ceplene must be injected slowly in the layer of tissue just under the skin (subcutaneously), over a period of approximately 5 to 15 minutes.
Slovenian: Zdravilo Ceplene je treba injicirati počasi, v plast tkiva neposredno pod kožo (subkutano), v času trajanja od približno 5 do 15 minut.
English: Rapid injection can cause a drop in your blood pressure and make you feel faint or even pass out.
Slovenian: Hitro injiciranje lahko povzroči padec krvnega tlaka, zaradi česar lahko občutite omotico ali se celo onesvestite.
English: Each 0.5 mL Ceplene dose is injected slowly, over 5-15 minutes.
Slovenian: Vsak 0,5 mL odmerek zdravila Ceplene se injicira počasi, in sicer v 5-15 minutah.
English: • Accumulation of fluid in the body especially in the legs (oedema)
Slovenian: • zadrževanje tekočine v telesu, zlasti v nogah (edem)
English: What Ceplene is and what it is used for What you need to know before you use Ceplene How to use Ceplene
Slovenian: Kaj je zdravilo Ceplene in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ceplene Kako uporabljati zdravilo Ceplene Možni neželeni učinki
English: Patients showed a higher degree of variability with respect to systemic exposure as compared to healthy subjects.
Slovenian: Pri bolnikih se je pokazala večja stopnja variabilnosti zaradi sistemske izpostavljenosti v primerjavi z zdravimi prostovoljci.
English: Where appropriate, consideration should be made to providing concomitant treatment with a proton pump inhibitor.
Slovenian: Kadar je potrebno, lahko razmislite o sočasnem zdravljenju z zaviralci protonske črpalke.
English: Ceplene is available in pack sizes of 14 vials.
Slovenian: Zdravilo Ceplene je na voljo v škatlah s 14 vialami.
English: You will start your treatment with Ceplene in the clinic under supervision of a doctor.
Slovenian: Zdravljenje z zdravilom Ceplene boste pričeli v bolnišnici pod nadzorom zdravnika.
English: Your doctor may want to increase the time you take to complete your injection, or change your dose.
Slovenian: Morda bo zdravnik podaljšal čas injiciranja ali spremenil odmerek zdravila.
English: • Feeling your own heart beat (palpitations)
Slovenian: • občutenje lastnega srčnega utripa (palpitacije)
English: Patients with a prior history of autoimmune disease (including systemic lupus, inflammatory bowel disease, psoriasis and rheumatoid arthritis) should be treated with caution.
Slovenian: Bolnike z avtoimunimi boleznimi v anamnezi (vključno s sistemskim lupusom, vnetno črevesno boleznijo, psoriazo in revmatoidnim artritisom) je treba zdraviti previdno.
English: • Dry skin
Slovenian: • suha koža
English: There have been 2 clinical studies to evaluate the use of Ceplene in the maintenance of remission in adult AML patients.
Slovenian: Izvedeni sta bili dve klinični študiji za ovrednotenje uporabe zdravila Ceplene pri vzdrževanju remisije pri odraslih bolnikih z akutno mieloično levkemijo.
English: • H2 blockers such as cimetidine, ranitidine, famotidine or nizatidine.
Slovenian: • Antagonisti H2, kot so cimetidin, ranitidin, famotidin ali nizatidin.
English: INSTRUCTIONS FOR INJECTION
Slovenian: NAVODILA ZA INJICIRANJE
English: If significant hypotension or related symptoms are observed in subsequent treatment cycles, dose reduction should be initiated and if required, administered in hospital until responses to treatment allow for home administration.
Slovenian: Če se pri bolniku med zdravljenjem v naslednjih ciklih očitno pojavi hipotenzija ali povezani simptomi, je treba ustrezno zmanjšati odmerek zdravila in po potrebi zdravilo injicirati v bolnišnici, dokler odziv na zdravljenje ne omogoči uporabe zdravila doma.
English: The randomised phase 3 trial (0201) compared Ceplene+IL-2 treatment to no treatment in 261 patients in first remission (CR1) and in another 59 patients in subsequent remission after relapse (CR>1).
Slovenian: V randomiziranem preskušanju faze 3 (0201) so primerjali sočasno zdravljenje z zdravilom Ceplene in IL-2 s stanjem brez zdravljenja pri 261 bolnikih v prvi remisiji (CR1), v drugem preskušanju pa 59 bolnikov v ponovni remisiji po relapsu (CR>1).
English: Your doctor may advise you that it is appropriate to use a syringe pump to regulate the injection of Ceplene.
Slovenian: Zdravnik vam lahko priporoča uporabo črpalke za brizgo za uravnavanje injiciranja zdravila Ceplene.
English: Decide where you will inject Ceplene.
Slovenian: Izberite mesto, kamor boste injicirali zdravilo Ceplene.
English: The mechanism by which Ceplene improves the anti-leukaemic function of lymphocytes in AML is not completely established; it is considered to be by inhibition of reactive oxygen species (ROS or ‘oxygen free radicals'), which are synthesised by monocytes/macrophages and granulocytes.
Slovenian: Mehanizem, s katerim zdravilo Ceplene izboljšuje protilevkemično delovanje limfocitov pri akutni mieloični levkemiji, še ni v celoti dognan, vendar naj bi zaviral reaktivne kisikove vrste (ROSreactive oxygen species ali kisikovi prosti radikali), ki jih sintetizirajo monociti/makrofagi in granulociti.
English: The active substance in Ceplene is histamine dihydrochloride; it is identical to a naturally occurring substance in the body.
Slovenian: Učinkovina v zdravilu Ceplene je histaminijev diklorid, ki je popolnoma enak kot snov, ki je naravno prisotna v človeškem telesu.
English: Ceplene is used in adult patients, together with IL-2, to treat a particular type of leukaemia called acute myeloid leukaemia (AML) which is a cancer of blood forming cells in the bone marrow.
Slovenian: Zdravilo Ceplene se uporablja pri odraslih bolnikih skupaj z IL-2 za zdravljenje specifične vrste levkemije, imenovane akutna mieloična levkemija (AML), ki je rak matičnih krvotvornih celic v kostnem mozgu.
English: Ceplene must not be mixed with any other products and must not be diluted.
Slovenian: Zdravila Ceplene ne smete mešati z nobenim drugim zdravilom in ga ne razredčevati.
English: The European Medicines Agency will review any new information on this medicine every year and this package leaflet will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke o tem zdravilu.
English: If the patient experiences a significant change in vital signs, the physician should evaluate the status of the patient and continue to monitor vital signs; these patients should be monitored during subsequent treatments.
Slovenian: Če se pri bolniku pojavijo bistvene spremembe v življenjskih znakih, mora zdravnik oceniti status bolnika in nadaljevati nadzor življenjskih znakov.
English: Push the plunger of the syringe down to inject air into the vial.
Slovenian: Bat brizge potisnite navzdol, tako da boste zrak iztisnili v vialo.
English: • a history of auto-immune disease (a disease where the immune system attacks the body's own cells or tissues, such as systemic lupus, rheumatoid arthritis, inflammatory bowel disease or psoriasis).
Slovenian: • avtoimunske bolezni v preteklosti (bolezen, pri kateri imunski sistem napada lastne telesne celice ali tkiva, kot je na primer sistemski lupus, revmatoidni artritis, vnetne črevesne bolezni ali psoriaza).
English: Dosing volumes based on patient weight are provided in Table 3 below.
Slovenian: Odmerni volumni, glede na telesno maso bolnika, so navedeni v Preglednici 3 spodaj.
English: Interleukin-2 (IL-2)
Slovenian: Interlevkin-2 (IL-2)