FrancophonIA/ELRC3.0 huggingface dataset:
English: Use an alcohol wipe to clean the rubber part of the stopper.
Slovenian: Z alkoholno krpico očistite gumijasti del zaporke.
English: The usual time for administering a 0.5 mL Ceplene dose is 5 minutes.
Slovenian: Običajni čas za injiciranje 0,5 mL zdravila Ceplene je 5 minut.
English: This is to be returned to the pharmacist for disposal.
Slovenian: To vrnite farmacevtu, ki bo zdravilo varno odstranil.
English: For further instructions on how to inject this medicine yourself, please read the section “INSTRUCTIONS FOR SELF-INJECTION OF CEPLENE” at the end of this leaflet.
Slovenian: Nadaljnja navodila za samoinjiciranje zdravila preberite v poglavju „NAVODILA ZA SAMOINJICIRANJE ZDRAVILA CEPLENE“ na koncu teh navodil za uporabo.
English: Subcutaneous use only.
Slovenian: Samo za subkutano uporabo.
English: Patients with all degrees of hepatic impairment may have tachycardia or hypotension for 30-60 minutes after Ceplene+IL-2 administration.
Slovenian: Pri bolnikih z različnimi stopnjami jetrnih okvar se lahko za 30-60 minut po uporabi zdravila Ceplene+IL-2 pojavi tahikardija ali hipotenzija.
English: • Inflammation of the stomach (gastritis)
Slovenian: • vnetje želodca (gastritis)
English: Ceplene should not be injected into the same anatomic region as IL-2.
Slovenian: Zdravilo Ceplene ne sme biti injicirano na isto anatomsko mesto kot IL-2.
English: If not, use another vial and inform your doctor or pharmacist.
Slovenian: Če ni, uporabite drugo vialo in o tem obvestite zdravnika ali farmacevta.
English: In the peri-post natal development study, high doses of histamine dihydrochloride caused maternal toxicity, and the offspring showed toxicity during lactation (fewer live pups at day 21 compared to lactation at day 4) but not after weaning.
Slovenian: Razvojne med- in postnatalne študije so pokazale, da visoki odmerki histaminijevega diklorida povzročajo toksičnost pri materi ter da se pri potomcih v obdobju sesanja kažejo znaki toksičnosti (manj živih mladičev v 21. dnevu sesanja, v primerjavi s 4 dnevom), vendar ne več v obdobju, ko nehajo sesati.
English: • If you are receiving one of the following medicines: - Steroids such as prednisone and dexamethasone.
Slovenian: • če jemljete katero od navedenih zdravil: - steroide, kot je prednizon in deksametazon.
English: Do not drive or use machines within one hour after receiving a Ceplene injection as it may reduce blood pressure causing dizziness, light-headedness and blurred vision.
Slovenian: Ne vozite in ne upravljajte strojev v času ene ure po uporabi zdravila Ceplene, saj lahko to povzroči znižanje krvnega tlaka in omotičnost, lahko glavo ter zamegljen vid, kar lahko vpliva na vašo sposobnost upravljanja vozil in strojev.
English: Injections should be preferably administered in a supervised setting in the presence of an adult family member, friend, or other care provider who is capable of responding appropriately should signs or symptoms of hypotension occur.
Slovenian: Injiciranje zdravila naj poteka v nadzorovanem okolju, v prisotnosti odraslega družinskega člana, prijatelja ali drugega skrbnika, sposobnega ustrezno reagirati v primeru pojava znakov ali simptomov hipotenzije pri bolniku.
English: Place the pre-prepared syringes containing IL-2, Ceplene and an opened alcohol wipe where you can reach them.
Slovenian: Pripravljeni brizgi z IL-2 in zdravilom Ceplene ter odprto alkoholno krpico položite tako, da jih lahko dosežete.
English: Interleukin-2 (IL-2) is commercially available as a recombinant IL-2; aldesleukin.
Slovenian: Interlevkin-2 (IL-2) je komercialno dostopen kot rekombinantni IL-2; aldeslevkin.
English: • Pain in limbs and back pain
Slovenian: • bolečine v okončinah in v hrbtu
English: Use only clear and colourless solution.
Slovenian: Uporabite samo bistro in brezbarvno raztopino.
English: Make sure that the area of the skin you select is exposed.
Slovenian: Prepričajte se, da je izbrano mesto dovolj razkrito.
English: They are used to inhibit activity of the immune system (immunosuppressant) and to reduce inflammation (see above “Do not use Ceplene”).
Slovenian: Ti se uporabljajo za zaviranje delovanja imunskega sistema (imunosupresiv) in za zmanjšanje vnetja (glejte poglavje zgoraj „Ne uporabljajte zdravila Ceplene“).
English: Caution should be used for patients with any of the following: symptomatic peripheral arterial disease, past or present peptic or oesophageal ulcer disease with a history of bleeding, clinically significant renal disease and stroke within the last 12 months.
Slovenian: Posebna previdnost je potrebna pri bolnikih, pri katerih se pojavlja simptomatska periferna arterijska bolezen, ki so imeli ali imajo peptično razjedo ali razjede požiralnika s krvavitvami v anamnezi, klinično pomembne ledvične bolezni in kap v zadnjih 12 mesecih.
English: • Infections of the upper breathing (respiratory) tract
Slovenian: • okužbe zgornjih dihalnih (respiratornih) poti
English: Patients with cardiac disease should be evaluated for ventricular ejection fraction and wall function by echocardiography or nuclear medicine stress test and then treated with caution.
Slovenian: Pri bolnikih s srčnimi boleznimi je treba ustrezno oceniti iztisni delež levega prekata in delovanje srčne stene z elektrokardiografom ali stresnim testom nuklearne medicine, pri zdravljenju pa je potrebna previdnost.
English: Tricyclic anti-depressants may have H1 and H2 receptor blocking properties and should be avoided.
Slovenian: Triciklični antidepresivi lahko imajo lastnosti antagonistov receptorjev H1 in H2 in se jim je zato treba izogibati.
English: Ceplene must be injected 1 to 3 minutes later.
Slovenian: Zdravilo Ceplene se injicira 1 do 3 minute kasneje.
English: Women of childbearing potential and sexually active men must use effective methods of contraception during treatment with Ceplene and IL-2.
Slovenian: Ženske v rodni dobi in spolno aktivni moški morajo med zdravljenjem z zdravilom Ceplene in IL-2 uporabljati učinkovito kontracepcijo.
English: Dispose of the syringe in the puncture-proof container as instructed.
Slovenian: Brizgo odvrzite v poseben zabojnik v skladu z navodili.
English: It is not known whether Ceplene appears in breast milk.
Slovenian: Ni znano, ali se zdravilo Ceplene pojavlja v mleku doječe matere.
English: They are used for angina and heart beat disorders.
Slovenian: Uporabljajo se za zdravljenje angine pektoris in motenj srčnega utripa.
English: Administration of Ceplene or IL-2 by rapid infusion or into vascular spaces, at higher doses than the approved ones, may exaggerate the adverse reactions associated with Ceplene.
Slovenian: Uporaba zdravila Ceplene ali IL-2 po hitrem injiciranju ali injiciranju v žilni prostor v višjih odmerkih kot so priporočeni, lahko stopnjuje neželene učinke, povezane z uporabo zdravila Ceplene.
English: For patients experiencing grade 3 and 4 (including hypotension, arrhythmia) toxicities - treatment should be discontinued until the event is resolved.
Slovenian: Za bolnike, pri katerih se pojavlja 3. in 4. stopnja toksičnosti (vključno s hipotenzijo, aritmijo) - zdravljenje je treba prekiniti, dokler dogodki ne izzvenijo.
English: • Joint and muscle pain (arthralgia and myalgia)
Slovenian: • bolečine v sklepih in mišicah (artralgija in mialgija)
English: • Headache and dizziness
Slovenian: • glavobol in omotičnost
English: • Decrease in the number of red blood cells (anaemia)
Slovenian: • upad števila rdečih krvnih celic (anemija)
English: It is unknown whether histamine is excreted in human breast milk.
Slovenian: Ni znano ali se histamin med dojenjem izloča v materino mleko.
English: Ceplene can be administered via an ambulatory infusion syringe pump or by controlled manual subcutaneous injection by syringe with a timer.
Slovenian: Zdravilo Ceplene se lahko daje z ambulantno infuzijo s črpalno injekcijo ali z nadzorovanim ročnim subkutanim injiciranjem z injekcijo z merilnikom časa.
English: For CR1 patients, the median duration of leukaemia-free survival increased from 291 days (9.7 months) to 450 days (15 months) after Ceplene/IL-2 versus no maintenance treatment (Intention to Treat [ITT], p=0.01.
Slovenian: Pri CR1 bolnikih se je po zdravljenju s kombinacijo zdravila Ceplene in IL-2 mediana trajanja preživetja brez levkemije podaljšala z 291 dni (9,7 meseca) na 450 dni (15 mesecev) v primerjavi z bolniki, ki niso prejemali vzdrževalnega zdravljenja (Intention to treat - z namenom zdravljenja [ITT], p=0,01, n=261).
English: The excretion of histamine in milk has not been studied in animals, but at maternotoxic doses in rats, offspring showed slight toxicity during early lactation (see section 5.3).
Slovenian: Izločanje histamina v mleko pri živalih ni bilo preučeno, pri podganah pa se je pri uporabi odmerkov, toksičnih za mater, pri potomcih pokazala rahla toksičnost med zgodnjo fazo dojenja (glejte poglavje 5.3).
English: For patients experiencing grade 1-4 generalised toxic dermatitis -for grade 1 toxicity, the treatment should be delayed for 48 hours or until all symptoms have been resolved.
Slovenian: Za bolnike, pri katerih se pojavlja 1.-4. stopnja generaliziranega toksičnega dermatitisa - pri 1. stopnji toksičnosti je treba zdravljenje prekiniti za 48 ur ali dokler simptomi ne izginejo.
English: The number of CR1 patients remaining leukaemia-free for 3 years was 40% after Ceplene+IL-2 versus 26% in patients not receiving this treatment (p=0.01).
Slovenian: Delež bolnikov iz skupine CR1, ki po zdravljenju z zdravilom Ceplene+IL-2 tri leta niso ponovno oboleli za levkemijo, je bil 40 % v primerjavi s 26 % bolnikov, ki niso prejemali tega zdravljenja (p=0,01).
English: • Any treatment for high blood pressure (for example thiazide diuretics [bendrofluazide], ACE inhibitors [captopril], calcium antagonists [nifedipine] and alpha-blockers [prazosin]).
Slovenian: • Katero koli drugo zdravilo za povišan krvni tlak (na primer tiazidni diuretiki [bendrofluazid], zaviralci ACE [kaptopril], kalcijevi antagonisti [nifedipin] ali zaviralci alfa [prazosin].
English: Table 2: For treatment cycles 4-10 with Ceplene and IL-2, same as for Table 1 above, with the exception of number of cycles and duration of rest periods
Slovenian: Preglednica 2: Za zdravljenje z zdravilom Ceplene in IL-2 v ciklih 4-10 velja enako, kot je navedeno v zgornji preglednici 1, z izjemo števila ciklov in trajanja obdobja brez zdravljenja.
English: Cycles w.19
Slovenian: Cikli t. 19
English: Doses of Ceplene and IL-2 should be modified as necessary based on individual patient tolerance to treatment.
Slovenian: Odmerke zdravila Ceplene in IL-2 po potrebi prilagodite toleranci na zdravljenje vsakega posameznega bolnika.
English: Ceplene with IL-2 will help your immune system attack any remaining cancer cells after a previous cancer treatment.
Slovenian: Zdravljenje z zdravilom Ceplene v kombinaciji z IL-2 bo vašemu imunskemu sistemu pomagalo napasti preostale rakave celice po predhodnem zdravljenju raka.
English: • The active substance is histamine dihydrochloride.
Slovenian: • Učinkovina je histaminijev diklorid.
English: ROS are known to limit the anti-leukaemic effects of lymphocyte activators such as IL-2, by triggering dysfunction and death by apoptosis in NK cells and T cells.
Slovenian: Znano je, da kisikove reaktivne vrste (ROS) omejujejo protilevkemične vplive limfocitnih aktivatorjev, kot je IL-2, s sprožanjem disfunkcije in smrti z apoptozo pri celicah ubijalkah (NK) in T celicah.
English: Should Ceplene related toxicities occur (such as hypotension, headache), the injection time can be increased from 5 minutes to a maximum duration of 15 minutes.
Slovenian: V primeru pojava toksičnih dogodkov zaradi uporabe zdravila Ceplene (kot je na primer hipotenzija, glavobol) se lahko čas trajanja injiciranja zdravila podaljša od 5 minut na največ 15 minut.
English: • For the first 18 weeks: you will use IL-2 and Ceplene daily for 3 weeks, followed by a 3 week break (no treatment at all).
Slovenian: • Prvih 18 tednov: IL-2 in zdravilo Ceplene boste uporabljali vsak dan 3 tedne, obdobju zdravljenja pa bodo sledili 3 tedni premora (brez kakršnega koli zdravljenja).
English: The usual dose of Ceplene is 0.5 mL of solution twice a day given as a slow subcutaneous injection (in the layer of tissue just under the skin).
Slovenian: Običajni odmerek zdravila Ceplene je 0,5 mL raztopine dvakrat na dan, dan s počasnim subkutanim injiciranjem (v plast tkiva neposredno pod kožo).
English: The diluted IL-2 (aldesleukin) is aseptically drawn up into sterile polypropylene tuberculin syringes and capped for each patient at 1 µg/kg dose, with a minimum standard dosage volume of 0.25 mL (50 µg) and a maximum dose of 0.5 mL (100 µg).
Slovenian: Razredčeni IL-2 (aldeslevkin) aseptično izvlecite v sterilne polipropilenske tuberkulinske brizge s pokrovčkom, za vsakega bolnika v odmerku 1 µg/kg telesne mase, z najmanjšim standardnim odmernim volumnom 0,25 mL (50 µg) in največjim odmerkom 0,5 mL (100 µg).
English: In subjects with severe renal impairment, there were decreases in systolic and diastolic blood pressure at plasma histamine concentrations which caused no appreciable decrease in blood pressure in other subjects.
Slovenian: Pri preiskovancih s hudo ledvično okvaro je pri plazemskih koncentracijah histamina prišlo do znižanja sistoličnega in diastoličnega krvnega tlaka, pri drugih preiskovancih pa znižanje krvnega tlaka ni bilo opazno.
English: Sodium chloride, water for injections, and sodium hydroxide and/or hydrochloric acid to adjust the pH.
Slovenian: Natrijev klorid, voda za injekcije in natrijev hidroksid in/ali klorovodikova kislina za uravnavanje pH.
English: Concurrent administration of medicinal products with cardiotoxicity or blood pressure lowering effects may increase the toxicity of Ceplene.
Slovenian: Sočasno zdravljenje s kardiotoksičnimi zdravili ali zdravili, ki znižujejo krvni tlak, lahko poveča toksičnost zdravila Ceplene.
English: Your doctor may decide that it would be more convenient for you to inject IL-2 and Ceplene yourself.
Slovenian: Zdravnik se lahko odloči, da si lahko IL-2 in zdravilo Ceplene injicirate sami.
English: IL-2 has to be injected first.
Slovenian: Najprej je treba injicirati IL-2.
English: Ceplene and IL-2 are administered for 10 treatment cycles: each cycle consists of a treatment period of 21 days (3 weeks) followed by a three-week or six-week treatment-free period.
Slovenian: Zdravili Ceplene in IL-2 se uporabljata v 10 ciklih zdravljenja: vsak cikel predstavlja 21-dnevno obdobje zdravljenja (3 tedni), temu pa sledi obdobje treh ali šestih tednov brez zdravljenja.
English: Vial
Slovenian: Viala
English: NOTE: The vial of Ceplene contains an overfill to facilitate the dose extraction of a single 0.5 mL dose.
Slovenian: OPOMBA: Viala zdravila Ceplene vsebuje presežek za lažji izvlek enkratnega 0,5 mL odmerka.
English: w.58
Slovenian: t. 58
English: With the needle cover on, pull back the plunger and draw air into the syringe to the level (number of millilitres) instructed by your doctor.
Slovenian: S pokrovčkom na igli potegnite bat brizge nazaj in v brizgo potegnite zrak do ravni (število mililitrov) v skladu z navodili zdravnika.
English: The adverse reactions considered at least possibly related to the treatment of low-dose IL-2 with Ceplene in AML studies (n=280 for the IL-2 and Ceplene treatment arm) are listed below by body system organ, class and frequency.
Slovenian: Neželeni učinki za katere se ocenjuje, da so vsaj verjetno povezani z zdravljenjem z majhnim odmerkom IL-2 skupaj z zdravilom Ceplene v študijah z bolniki z akutno mieloično levkemijo (n=280 za skupino, zdravljeno z IL-2 in zdravilom Ceplene), so navedeni spodaj glede na razrede organskih sistemov in pogostnost.
English: It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Slovenian: Zelo pomembno je, da si ne poskušate zdravila injicirati sami, preden vas zdravnik ali medicinska sestra o tem ustrezno ne pouči.
English: Table 1: For treatment cycles 1-3 with Ceplene and IL-2
Slovenian: Preglednica 1: Za cikle zdravljenja 1-3 z zdravilom Ceplene in IL-2.
English: Dilute IL-2 dispensed in capped polypropylene tuberculin syringes is to be prepared by the pharmacy in a controlled aseptic environment and stored in a refrigerator at 2°C - 8°C.
Slovenian: Razredčeni IL-2, odmerjen v polipropilenske tuberkulinske brizge s pokrovčkom, mora pripraviti farmacevt v kontroliranih aseptičnih pogojih in hraniti v hladilniku pri temperaturi 2°C - 8°C.
English: A study was performed to measure the PK of histamine in normal volunteers compared to patients with mild, moderate, and severe hepatic impairment.
Slovenian: Izvedena je bila študija za primerjavo farmakokinetike histamina pri zdravih prostovoljcih v primerjavi z bolniki z blagimi, zmernimi ali hudimi jetrnimi okvarami.
English: The most common adverse reactions experienced by 30% or more of patients receiving IL-2 and Ceplene (listed in descending order of frequency) were: flushing, headache, fatigue, injection site granuloma, pyrexia and injection site erythema.
Slovenian: Najpogostejši neželeni učinki, ki so se pojavili pri 30 % bolnikov ali več, zdravljenih z IL-2 in zdravilom Ceplene (padajoče navedeni glede na pogostnost), so bili: zardevanje, glavobol, utrujenost, granulom na mestu injiciranja, povišana telesna temperatura in eritem na mestu injiciranja.
English: The vials contain 0.70 mL of solution (including overfill) to facilitate the dose extraction of a single 0.5 mL dose.
Slovenian: Viale vsebujejo 0,70 mL raztopine (vključno s presežkom), kar omogoča izvlek odmerka za enkraten 0,5 mL odmerek.
English: Ceplene should be used with caution in patients with moderate to severe hepatic impairment (see section 5.2).
Slovenian: Pri bolnikih z zmerno do hudo jetrno okvaro je treba zdravilo Ceplene uporabljati previdno (glejte poglavje 5.2).
English: 2 mL type I glass vial, with bromobutyl rubber stopper and flip-off aluminium over seal, containing 0.5 mL of solution (0.70 mL including overfill).
Slovenian: 2 mL steklena viala tipa I, z bromobutilnim gumijastim zamaškom in odstranljivo aluminijasto zaporko, ki vsebuje 0,5 mL raztopine (0,70 mL vključno s presežkom).
English: The pharmacokinetics of histamine are similar in healthy volunteers with normal renal function compared to volunteers with mild, moderate, or severe renal impairment.
Slovenian: Farmakokinetika histamina je podobna pri zdravih prostovoljcih z normalnim delovanjem ledvic in pri prostovoljcih z blago, zmerno ali hudo ledvično okvaro.
English: Your doctor will let you know how much it is and how to inject it.
Slovenian: Zdravnik vam bo predpisal količino odmerka in način injiciranja.
English: • If you have received a stem cell transplant (a kind of bone marrow transplant) from a donor.
Slovenian: • če so vam presadili matične celice (vrsta presaditve kostnega mozga).
English: to w.81
Slovenian: do t. 81
English: • Altered taste (dysgeusia)
Slovenian: • spremenjen okus (disgevzija)
English: Histamine dihydrochloride was not teratogenic in rats or rabbits at doses resulting in several hundredfold greater systemic exposures than the clinical exposure.
Slovenian: Histaminijev diklorid pri podganah ali kuncih v odmerkih z nekaj stokrat večjo sistemsko izpostavljenostjo kot pri klinični izpostavljenosti ni bil teratogen.
English: If you feel faint or dizzy during or after the injections, tell your doctor before injecting your next dose.
Slovenian: Če med ali po injiciranju občutite omedlevico ali vrtoglavico, pred naslednjim injiciranjem o tem obvestite zdravnika.
English: Ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia (AML) in first remission concomitantly treated with interleukin-2 (IL-2).
Slovenian: Vzdrževalno zdravljenje z zdravilom Ceplene je indicirano pri odraslih bolnikih z akutno mieloično levkemijo (AML) ob prvi remisiji, ob sočasnem zdravljenju z interlevkinom-2 (IL-2).
English: 12 Take the needle out of the vial.
Slovenian: Iglo vzemite iz viale.
English: Beta-blockers and other anti-hypertensive agents should be used with caution during treatment with Ceplene.
Slovenian: Antagoniste adrenergičnih receptorjev beta in druga antihipertenzivna zdravila je treba v času zdravljenja z zdravilom Ceplene uporabljati previdno.
English: Apply gentle pressure with the alcohol wipe over the injection site without rubbing it. 14.
Slovenian: Nežno pritisnite na mesto injiciranja z alkoholno krpico, vendar ga pri tem ne drgnite.
English: w.13 to w.15 (Days 1-21)
Slovenian: t. 13 do t. 15 (dnevi 1-21)
English: What Ceplene looks like and contents of the pack
Slovenian: Izgled zdravila Ceplene in vsebina pakiranja
English: Blood and lymphatic system disorders anaemia
Slovenian: Bolezni krvi in limfatičnega sistema anemija pogosti
English: The MAH shall provide yearly updates on any new information concerning efficacy and safety of the product in patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (IL-2).
Slovenian: Imetnik dovoljenja za promet z zdravilom mora letno predložiti posodobitev vseh novih podatkov o učinkovitosti in varnosti zdravila pri bolnikih z akutno mieloično levkemijo ob prvi remisiji, ob sočasnem zdravljenju z interlevkinom-2 (IL-2).
English: The first dose of Ceplene and IL-2 on day 1 of the initiation of the first cycle of treatment should be administered in the clinic under direct supervision by a physician.
Slovenian: Prvo injiciranje odmerka zdravila Ceplene in IL-2 na prvi dan prvega cikla zdravljenja naj poteka na kliniki pod neposrednim nadzorom zdravnika.
English: Side effects observed when Ceplene is used as described in this package leaflet:
Slovenian: Neželeni učinki, ki so jih opazili pri uporabi zdravila Ceplene, kot je navedena v tem navodilu za uporabo:
English: to w.48
Slovenian: do t. 48
English: Slowly pull back the plunger to draw the solution into the syringe, filling it to the level (number of millilitres) instructed by your doctor.
Slovenian: Počasi potegnite bat nazaj in v brizgo potegnite raztopino do ravni (število mililitrov), kot vam je naročil vaš zdravnik.
English: • Certain anti-psychotics such as chlorpromazine, flupenthixol, thoridazine, clozapine and risperidone.
Slovenian: • Določeni antipsihotiki, kot so klorpromazin, flupentiksol, tioridazin, klozapin in risperidon.
English: Abnormal WBC counts - the dose of IL-2 can be reduced by 20% for the remaining duration of the treatment course and if abnormal WBC counts re-occur during the following cycle a permanent IL-2 reduction is recommended.
Slovenian: Nenormalno število belih krvnih telesc - odmerek IL-2 lahko za preostali čas zdravljenja zmanjšate za 20 %, če pa se nenormalno število belih krvnih telesc med naslednjim ciklom zdravljenja ponovno pojavi, je priporočeno trajno zmanjšanje odmerka IL-2.
English: If you want to stop taking Ceplene you should try to consult your doctor in advance.
Slovenian: Če ste prenehali uporabljati zdravilo Ceplene Če želite prenehati z jemanjem zdravila Ceplene, se prej posvetujte z zdravnikom.
English: Clear, colourless aqueous solution.
Slovenian: Bistra, brezbarvna vodna raztopina.
English: Nervous system disorders headache, dizziness, dysgeusia Very common
Slovenian: Bolezni živčevja glavobol, omotičnost, disgevzija zelo pogosti
English: IL-2 (aldesleukin) should be aseptically reconstituted, diluted and dispensed in capped polypropylene tuberculin syringes by the pharmacy based on the individual patient's weight (see administration chart for aldesleukin below) at the recommended dose of 16 400 IU/kg (1 µg/kg).
Slovenian: IL-2 (aldeslevkin) farmacevt v aseptičnih pogojih rekonstituira, razredči in odmeri v polipropilenske tuberkulinske brizge s pokrovčkom glede na telesno maso posameznega bolnika (glejte tabelo odmerjanja aldeslevkina, spodaj) v priporočenem odmerku 16.400 i.e./kg telesne mase (1 µg/kg).
English: Ceplene is for subcutaneous use only.
Slovenian: Način uporabe Zdravilo Ceplene je samo za subkutano uporabo.
English: Histamine concentrations and PK were highly variable across studies, as well as within the normal volunteer and patient groups.
Slovenian: Koncentracije histamina in farmakokinetika so se med študijami zelo spreminjale, tako pri skupinah zdravih prostovoljcev kot pri bolnikih.