FrancophonIA/ELRC3.0 huggingface dataset:
English: Ceplene must be injected 1 to 3 minutes later.
Maltese: Ceplene għandu jiġi injettat bejn minuta u 3 minuti wara.
English: • Joint and muscle pain (arthralgia and myalgia)
Maltese: • Uġigħ fil-muskoli u fil-ġogi (artralġija u mijalġija)
English: Patients with all degrees of hepatic impairment may have tachycardia or hypotension for 30-60 minutes after Ceplene+IL-2 administration.
Maltese: Il-pazjenti bil-gradi kollha ta' insuffiċjenza epatika jista' jkollhom takikardija jew ipotensjoni għal 30-60 minuta wara għoti ta' Ceplene+IL-2.
English: (hypothyroidism)
Maltese: (mL)
English: See Figure 6.
Maltese: Ara l-Figura 6.
English: Monoamine oxidase inhibitors, anti-malarial, and anti-trypanosomal active substances may alter the metabolism of Ceplene and should be avoided (see section 4.4).
Maltese: Inibituri ta' monoamine oxidase u sustanzi attivi kontra l-malarja u antitripanosomiċi jistgħu jbiddlu lmetaboliżmu ta' Ceplene u għandhom jiġu evitati (ara sezzjoni 4.4).
English: Ceplene should be used with caution in patients with moderate to severe hepatic impairment (see section 5.2).
Maltese: Ceplene għandu jintuża b'kawtela f'pazjenti b'insuffiċjenza epatika minn moderata għal severa (ara sezzjoni 5.2).
English: to w.30
Maltese: ġ. 28 sa ġ.30
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.
Maltese: Pazjenti b'mard kardijaku għandhom jiġu evalwati għal frazzjoni ta' tfigħ 'il barra (ejection fraction) ventrikolari u l-funzjoni parjetali (wall function) permezz ta' ekokardjografija jew test ta' stress bil-mediċina nukleari u mbagħad ittrattati b'kawtela.
English: • Dry skin
Maltese: U LUŻU
English: 0.5 mL solution is sufficient for a single dose (see section 6.6).
Maltese: Soluzzjoni ta' 0.5 mL hija biżżejjed għal doża waħda (ara sezzjoni 6.6).
English: Studies have shown chemical stability and sterility of diluted aldesleukin (dispensed in capped polypropylene tuberculin syringes) for up to three weeks when prepared in a controlled aseptic environment and stored under refrigeration at 2°C - 8°C.
Maltese: Studji wrew stabbilità u sterilità kimika ta' aldesleukin dilwit (imqassam f'siringi ta' tuberkulin magħmula minn polypropylene u magħluqa b'tapp) sa tliet ġimgħat meta ippreparat f'ambjent asettiku ikkontrollat u maħżun fi friġġ f'temperatura ta' 2°C - 8°C.
English: Other oncology (advanced tumour) studies
Maltese: Studji onkoloġiċi (tumuri avvanzati) oħrajn
English: • Altered taste (dysgeusia)
Maltese: • Bidla fit-togħma (disġewsija)
English: The active substance in Ceplene is histamine dihydrochloride; it is identical to a naturally occurring substance in the body.
Maltese: Is-sustanza attiva f'Ceplene hija l-istamina; dikloridrat, din hija identika għal sustanza li tinstab b'mod naturali fil-ġisem.
English: • Inflammation of the stomach (gastritis)
Maltese: • Infjammazzjoni tal-istonku (gastrite)
English: See Figure 1.
Maltese: Ara lFigura 1.
English: w.40
Maltese: ġ.40
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.
Maltese: Għadd anormali ta' WBC - id-doża ta' IL-2 tista' titnaqqas b'20% għall-kumplament taż-żmien tal-kors ta' trattament u jekk jerġgħu jseħħu għadd ta' WBC anormali waqt iċ-ċiklu li jmiss, huwa rrakkomandat tnaqqis permanenti ta' IL-2.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated-dose toxicity, local tolerance and genotoxicity.
Maltese: Tagħrif mhux kliniku ma juri l-ebda periklu speċjali għall-bnedmin abbażi ta' studji konvenzjonali ta' tossiċità ta' doża ripetuta, tolleranza lokali u ġenotossiċità.
English: IL-2 is administered twice daily as a subcutaneous injection 1 to 3 minutes prior to the administration of Ceplene; each dose of IL-2 is 16,400 IU/kg (1 µg/kg).
Maltese: IL-2 jingħata darbtejn kuljum bħala injezzjoni taħt il-ġilda minn minuta sa 3 minuti qabel l-għoti ta' Ceplene; kull doża ta' IL-2 hija 16,400
English: Metabolism and nutrition disorders decreased appetite
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni tnaqqis fl-aptit
English: • Patients with significantly compromised cardiac function, e.g., NYHA Class III/IV.
Maltese: • Pazjenti b'funzjoni kardijaka kompromessa b'mod sinifikanti, eż.
English: For cycles 1-3, each cycle consists of 3 weeks of treatment, followed by a 3-week treatment free period.
Maltese: Għaċ-ċikli 1-3, kull ċiklu jikkonsisti minn 3 ġimgħat trattament, segwit minn perjodu mingħajr trattament ta' 3 ġimgħat.
English: System organ class
Maltese: NYHA Klassi
English: Patients with a prior history of autoimmune disease (including systemic lupus, inflammatory bowel disease, psoriasis and rheumatoid arthritis) should be treated with caution.
Maltese: Pazjenti bi storja preċedenti ta' mard awtoimmunitarju (inkluż lupus sistemiku, marda infjammatorja intestinali, psorijażi u artrite rewmatojde) għandhom ikunu ttrattati b'kawtela.
English: Adverse reaction
Maltese: MANIFATTUR RESPONSABBLI
English: The usual time for administering a 0.5 mL Ceplene dose is 5 minutes.
Maltese: Il-ħin normalment meħtieġ biex tingħata doża ta' 0.5 mL ta' Ceplene huwa ta' 5 minuti.
English: Other medicines and Ceplene
Maltese: Mediċini oħra u Ceplene
English: Histamine dihydrochloride was not teratogenic in rats or rabbits at doses resulting in several hundredfold greater systemic exposures than the clinical exposure.
Maltese: Histamine dihydrochloride ma kienx teratoġeniku fil-firien jew fniek f'dożi li jirriżultaw f'esponimenti diversi mitt darba ikbar mill-esponiment kliniku.
English: Vascular disorders hot flush
Maltese: Disturbi vaskulari fwawar ta' sħana
English: • Difficulty in sleeping (insomnia)
Maltese: • Diffikultà biex torqod (insonnja)
English: Pick up the sterile syringe.
Maltese: Iġbor is-siringa sterili.
English: The dose reductions can be temporary or permanent.
Maltese: It-tnaqqis fid-doża jista' jkun temporanju jew permanenti.
English: Very common palpitations
Maltese: Komuni ħafna palpitazzjonijiet
English: Histamine concentrations and PK were highly variable across studies, as well as within the normal volunteer and patient groups.
Maltese: Konċentrazzjonijiet ta' istamina u PK huma ferm varjabbli matul l-istudji, kif ukoll fi gruppi ta' voluntiera normali u pazjenti.
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Maltese: Idrossidu tas-sodju (għal aġġustament tal-pH) Aċidu idrokloriku (għal aġġustament tal-pH)
English: The mean half-life was 0.75 to 1.5 hours in patients.
Maltese: Fil-pazjenti, il-half-life medja kienet ta' 0.75 sa 1.5 sigħat.
English: • If you are receiving one of the following medicines: - Steroids such as prednisone and dexamethasone.
Maltese: • Jekk tkun qed tieħu xi waħda minn dawn il-mediċini: - Sterojdi bħal prednisone u dexamethasone.
English: • Rapid heart beat (tachycardia)
Maltese: • Żieda fit-taħbit tal-qalb (takikardija)
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.
Maltese: IL-2 dilwit imqassam f'siringi ta' tuberkulin magħmula minn polypropylene u magħluqa b'tapp għandu jiġi ppreparat mill-ispiżerija f'ambjent asettiku kkontrollat u maħżun fi friġġ f'temperatura ta' 2°C - 8°C.
English: Summary of the safety profile
Maltese: Sommarju tal-profil tas-sikurezza
English: Ceplene/IL-2 is an immunotherapy which aims to induce immune-mediated destruction of residual myeloid leukaemic cells and thereby to prevent relapse of leukaemia.
Maltese: Ceplene/IL-2 huwa immunoterapija li jimmira li jinduċi qerda immuno-medjata ta' ċelloli residwi tallewċemija mjelojde u permezz ta' dan jimpedixxi rikaduta tal-lewċemija.
English: The vials contain 0.70 mL of solution (including overfill) to facilitate the dose extraction of a single 0.5 mL dose.
Maltese: Il-kunjetti fihom 0.70 mL ta' soluzzjoni (inkluża l-parti mfawra) biex tiffaċilita l-estrazzjoni ta' doża singola ta' 0.5 mL.
English: Treatment can be resumed by administering Ceplene at the full dose and IL-2 at 50%.
Maltese: jinbeda bl-għoti ta' Ceplene fid-doża sħiħa u IL-2 f'50%.
English: By inhibiting oxidase function and reducing ROS production, Ceplene protects IL-2-activated NK cells and T cells from oxygen free radical-induced inhibition and apoptosis.
Maltese: Billi jinibixxi lfunzjoni ta' oxidase u jnaqqas il-produzzjoni tar-ROS, Ceplene jipproteġi ċ-ċelloli NK u ċ-ċelloli T attivati minn IL-2 mill-inibizzjoni indotta mir-radikali liberi mill-ossiġenu u mill-apoptożi.
English: H1 receptor blocking antihistamines or neuroleptics (anti-psychotics) with H1 receptor blocking properties that might decrease efficacy of Ceplene should be avoided.
Maltese: Antistaminiċi li jimblokkaw ir-riċettur H1 jew newrolettiċi (antipsikotiċi) b'karatteristiċi li jimblokkaw ir-riċetturi H1 li jistgħu jnaqqsu l-effikaċja ta' Ceplene għandhom jiġu evitati.
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.
Maltese: IL-2 u Ceplene (elenkati f'ordni ta' frekwenza li tonqos) kienu: fwawar, uġigħ ta' ras, għeja, granuloma fis-sit tal-injezzjoni, piressija u eritema fis-sit tal-injezzjoni.
English: Cardiac disorders tachycardia
Maltese: Disturbi fil-qalb takikardija
English: Vial
Maltese: Kunjett
English: • Nasal congestion
Maltese: • Konġestjoni nażali
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Maltese: Peress li din hi approvazzjoni taħt ċirkustanzi eċċezzjonali u skont l-Artikolu 14(8) tar-Regolament (KE) 726/2004, l-MAH għandu jwettaq, fiż-żmien stipulat, il-miżuri li gejjin:
English: They are used to treat depression.
Maltese: Jintużaw fittrattament tad-depressjoni.
English: - H2 blockers such as cimetidine, ranitidine, famotidine or nizatidine which are used to treat stomach ulcers, indigestion (dyspepsia) or heartburn.
Maltese: - Imblokkaturi H2 bħal ċimetidina (cimetidine), ranitidina (ranitidine), famotidina (famotidine) jew nizatidina (nizatidine) li jintużaw biex jittrattaw l-ulċeri fl-istonku, l-indiġestjoni (dispepsija) jew il-ħruq ta' stonku.
English: - for cardiac, hepatic or renal toxicities the dose should be reduced by 20% for both Ceplene and IL-2.
Maltese: - għal tossiċitajiet kardijaċi, epatiċi jew renali, id-doża għandha titnaqqas b'20% kemm għal Ceplene kif ukoll għal IL-2.
English: Plasma Ceplene levels are higher in patients with moderate and severe liver impairment, and these patient groups tend to experience more tachycardia and lower blood pressure after Ceplene dosing than do patients with normal or mildly affected liver function.
Maltese: Il-livelli ta' Ceplene fil-plażma huma ogħla f'pazjenti b'insuffiċjenza epatika moderata u severa, u dawn il-gruppi ta' pazjenti għandhom it-tendenza li jesperjenzaw iktar takikardija u pressjoni tad-demm iktar baxxa wara dożaġġ b'Ceplene milli pazjenti b'funzjoni tal-fwied normali jew affettwata b'mod ħafif.
English: The treatment with IL-2 and Ceplene lasts for 81 weeks and is cyclic.
Maltese: It-trattament b'IL-2 u Ceplene idum 81 ġimgħat u huwa ċikliku.
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.
Maltese: Għall-pazjenti li qegħdin jesperjenzaw dermatite tossika ġeneralizzata minn grad 1 sa 4 - għal tossiċità ta' grad 1, it-trattament għandu jiġi ttardjat bi 48 siegħa jew sakemm jirrisolvu s-sintomi kollha.
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.
Maltese: Tintuża flimkien ma' dożi baxxi ta' interleukin-2 (IL-2), mediċina oħra li tgħin lis-sistema immunitarja tikkumbatti mard bħall-kanċer.
English: Concurrent administration of medicinal products with cardiotoxicity or blood pressure lowering effects may increase the toxicity of Ceplene.
Maltese: Għoti komkomitanti ta' prodotti mediċinali b'effetti ta' kardjotossiċità jew li jbaxxu l-pressjoni taddemm jistgħu jżidu t-tossiċità ta' Ceplene.
English: Psychiatric disorders anxiety
Maltese: Disturbi psikjatriċi ansjetà
English: Recommended dose
Maltese: Doża rakkomandata
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
Maltese: Kunjett ta' soluzzjoni ta' Ceplene (0.5 mL) Siringa sterili mmarkata b'marki tal-kejl b'labra Biċċa mbilla fl-alkoħol biex timsaħ (alcohol wipe[s])
English: One vial of 0.5 mL of solution contains 0.5 mg of histamine dihydrochloride.
Maltese: Kunjett wieħed ta' 0.5 mL ta' soluzzjoni fiha 0.5 mg ta' histamine dihydrochloride.
English: • Anxiety
Maltese: • Ansjetà
English: Ceplene 0.5 mg/0.5 mL solution for injection histamine dihydrochloride Subcutaneous use only
Maltese: Ceplene 0.5 mg/0.5 mL soluzzjoni għall-injezzjoni histamine dihydrochloride Użu taħt il-ġilda biss
English: Respiratory, thoracic, and mediastinal disorders wheezing
Maltese: Disturbi respiratorji, toraċiċi u medjastinali tħarħir
English: See Figure 3.
Maltese: Ara lFigura 3.
English: Nervous system disorders headache, dizziness, dysgeusia Very common
Maltese: Disturbi fis-sistema nervuża uġigħ ta' ras, sturdament, disġewżja
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.
Maltese: Jekk iseħħu tossiċitajiet relatati ma' Ceplene (bħalma huma ipotensjoni, uġigħ ta' ras), il-ħin għallinjezzjoni jista' jiżdied minn 5 minuti sa tul massimu ta' 15-il minuta.
English: One vial of 0.5 mL of solution contains 0.5 mg histamine dihydrochloride.
Maltese: Kunjett ta' 0.5 ml tas-soluzzjoni fiha 0.5 mg ta' histamine dihydrochloride.
English: For patients experiencing grade 1 toxicity events
Maltese: Għall-pazjenti li qegħdin jesperjenzaw episodju ta' tossiċità ta' grad 1
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).
Maltese: Ġie nnotat li aġenti imblokkaturi newromuskolari, analġeżiċi narkotiċi, u diversi mezzi ta' kuntrast jistgħu jinduċu t-tnixxija ta' istamina endoġena; għaldaqstant f'pazjenti li qegħdin isirulhom proċeduri dijanjostiċi jew kirurġiċi, l-effett addittiv tat-trattament b'Ceplene għandu jkun ikkunsidrat qabel ilproċedura (ara sezzjoni 4.4).
English: General disorders and administration site conditions malaise, oedema peripheral
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata telqa, edima periferali
English: General disorders and administration site conditions injection site granuloma, fatigue, pyrexia, injection site erythema, feeling hot, injection site reaction, injection site pruritus, influenza like illness, chills, injection site inflammation, injection site pain
Maltese: Studji fl-annimali juru tossiċità riproduttiva biss f'dożi maternotossiċi, u ma jindikawx effetti ta' ħsara diretta fir-rigward tattqala, żvilupp embrijonali, fetali, ħlas jew żvilupp ta' wara t-twelid (ara sezzjoni 5.3). Ceplene flimkien ma' IL-2 ma għandhiex tintuża waqt it-tqala.
English: Each 0.5 mL Ceplene dose is injected slowly, over 5-15 minutes.
Maltese: Kull doża ta' 0.5 mL ta' Ceplene tiġi injettata bil-mod, fuq perjodu minn 5 sa 15-il minuta.
English: • Keep this leaflet.
Maltese: • Waqt it-tqala.
English: Ceplene belongs to a group of medicines called immunomodulatory medicines.
Maltese: Ceplene jagħmel parti minn grupp ta' mediċini magħrufa bħala mediċini immunomodulatorji.
English: Ceplene should be administered 1 to 3 minutes after IL-2 administration, and not concomitantly.
Maltese: Ceplene għandu jingħata minn minuta sa 3 minuti wara għoti ta' IL-2, u mhux b'mod konkomittanti.
English: Adverse reactions were reported to be at least possibly related to IL-2 and Ceplene treatment in almost all patients in studies in AML.
Maltese: Reazzjonijiet avversi li kienu tal-inqas possibbilment relatati mat-trattament b'IL-2 u Ceplene kienu rrapportati kważi fil-pazjenti kollha fi studji dwar AML.
English: Ceplene maintenance therapy should be administered following completion of consolidation therapy in patients concomitantly treated with IL-2 under the supervision of a physician experienced in the management of acute myeloid leukaemia.
Maltese: Terapija ta' manteniment ta' Ceplene għandha tingħata wara t-tmiem ta' terapija ta' konsolidament f'pazjenti kkurati wkoll b'IL-2 taħt is-sorveljanza ta' tabib b'esperjenza fil-ġestjoni ta' lewkimja mjelojde akuta.
English: There were no clinically significant differences in safety parameters or in pharmacodynamics.
Maltese: Ma kien hemm l-ebda differenza sinifikanti filparametri ta' sigurtà jew fil-farmakodinamika.
English: Cycle 1 Cycle 2 Cycle 3 w.1 to w.3 (Days 1-21)
Maltese: ġ.1 sa ġ.3 (Jiem 1-21)
English: The two medicines, IL-2 and Ceplene, are both injected twice a day, with a minimum of 6 hours between injections.
Maltese: Iż-żewġ mediċini, IL-2 u Ceplene, jiġu injettati darbtejn kuljum, b'intervall ta' mill-inqas 6 sigħat bejn iż-żewġ injezzjonijiet.
English: Blood and lymphatic system disorders eosinophilia, thrombocytopenia Very common leucopenia, neutropenia
Maltese: Disturbi tad-demm u tassistema limfatika esinofilja, tromboċitopenija
English: A study was performed to measure the PK of histamine in normal volunteers compared to patients with mild, moderate, and severe hepatic impairment.
Maltese: Sar studju biex ikejjel il-PK tal-istamina f'voluntiera normali meta mqabbla ma' pazjenti b'insuffiċjenza epatika ħafifa, moderata jew gravi.
English: No altered dose recommendations with the exception of grade 1 neurologic toxicity and grade 1 generalised toxic dermatitis.
Maltese: L-ebda tibdil fir-rakkomandazzjonijiet tad-doża ħlief għal tossiċità newroloġika ta' grad 1 u dermatite tossika ġeneralizzata ta' grad 1.
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.
Maltese: L-injezzjonijiet għandhom preferibbilment jingħataw f'sitwazzjoni sorveljata fil-preżenza ta' membru tal-familja adult, ħabib, jew xi ħaddieħor li jagħti t-trattament li huwa kapaċi jirreaġixxi b'mod adegwat jekk iseħħu sinjali jew sintomi ta' ipotensjoni.
English: Sodium chloride, water for injections, and sodium hydroxide and/or hydrochloric acid to adjust the pH.
Maltese: Klorur tas-sodju, ilma għall-injezzjonijiet, u idrossidu tas-sodju u/jew aċidu idrokloriku għallaġġustament tal-pH.
English: OTHER
Maltese: Figura
English: Posology
Maltese: Deskrizzjoni
English: 6 week break (no treatment at all).
Maltese: 6 ġimgħat (mingħajr ebda trattament).
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).
Maltese: • storja ta' mard awtoimmuni (marda fejn is-sistema immunitarja tattakka ċ-ċelloli jew it-tessuti tal-ġisem stess, bħal lupus sistemiku, artrite rewmatojde, mard infjammatorju intestinali jew psorijażi).
English: For patients experiencing grade 3 and 4 (including hypotension, arrhythmia) toxicities - treatment should be discontinued until the event is resolved.
Maltese: Għal pazjenti li qegħdin jesperjenzaw tossiċitajiet ta' grad 3 u 4 (inklużi ipotensjoni, aritmija) - it-trattament għandu jieqaf sakemm l-episodju jkun ġie solvut.
English: For persistent hypotension, headache, arrhythmia, cardiac, hepatic and renal toxicities - the time of injection of the dose of Ceplene should be extended to a maximum of 15 minutes.
Maltese: Għall-ipotensjoni persistenti, l-uġigħ ta' ras, l-aritmija, it-tossiċitajiet kardijaċi, epatiċi u renali - il-perjodu tal-injezzjoni tad-doża ta' Ceplene għandu jittawwal sa massimu ta' 15-il minuta.
English: Women of childbearing potential and sexually active men must use effective methods of contraception during treatment with Ceplene and IL-2.
Maltese: Nisa li jistgħu joħorġu tqal u rġiel attivi sesswalment għandhom jużaw metodi effettivi ta' kontraċezzjoni waqt il-kura b'Ceplene u IL-2.
English: For instructions on reconstitution and dilution of Interleukin-2 (aldesleukin) before administration, see commercially available IL-2 SmPC.
Maltese: Għal istruzzjonijiet fuq ir-rikostituzzjoni u d-dilwizzjoni ta' Interleukin-2 (aldesleukin) qabel lamministrazzjoni, ara IL-2 SmPC disponibbli b'mod kummerċjali.
English: Each carton contains 14 vials.
Maltese: Kull pakkett fih 14-il kunjett.
English: Blood and lymphatic system disorders anaemia
Maltese: Disturbi tad-demm u tassistema limfatika anemija
English: Very common injection site urticaria, injection site bruising, injection site rash, injection site swelling, asthenia, chest pain
Maltese: Komuni ħafna urtikarja fis-sit tal-injezzjoni, tbenġil fis-sit tal-injezzjoni, raxx fis-sit tal-injezzjoni, nefħa fis-sit tal-injezzjoni, astenja, uġigħ fis-sider
English: For instructions on the initial reconstitution and subsequent dilution to 200 µg/mL of Interleukin-2 (aldesleukin) before administration, see commercially available IL-2 SmPC.
Maltese: Għal istruzzjonijiet dwar ir-rikostituzzjoni tal-bidu u d-dilwizzjoni sussegwenti sa 200 µg/mL ta' Interleukin-2 (aldesleukin) qabel ma jingħata, ara l-SmPC
English: Figure 2
Maltese: Ċiklu 2
English: Rapid subcutaneous injection or injection into a vascular space may result in severe hypotension, tachycardia, or syncope.
Maltese: Injezzjoni taħt il-ġilda rapida jew injezzjoni ġewwa spazju vaskulari tista' tirriżulta f'ipotensjoni severa, takikardija, jew sinkope.
English: The dispensing and storage directions in the section 6.6 are specific to aldesleukin.
Maltese: Ittqassim u struzzjonijiet dwar il-ħażna fis-sezzjoni 6.6 huma speċifiċi għal aldesleukin.
English: - H1 blocking agents and neuroleptics (anti-psychotics) with H1 receptor blocking properties.
Maltese: - Mediċini li jimbokkaw H1 u newrolettiċi (antipsikotiċi) b'karatteristiċi li jimblokkaw ir-riċetturi
English: • If you are breast-feeding.
Maltese: • Jekk tkun tqila.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I : Sommarju tal- Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: Treatment cycles
Maltese: TAL-PRODOTT MEDIĊINALI
English: Ceplene and IL-2 must not be injected into the same region.
Maltese: Ceplene u IL-2 ma għandhomx jiġu injettati fl-istess ħin.
English: Obtain new supplies and start the procedure over again, even if 3 minutes have passed after injection of IL-2.
Maltese: Iġbed il-mediċina mill-ġdid u erġa' ibda l-proċedura mill-ġdid, anke jekk ikunu għaddew 3 minuti mill-ewwel injezzjoni ta' IL-2.
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).
Maltese: L-MAH tipprovdi aġġornament ta' kull sena dwar kwalunkwe informazzjoni ġdida dwar l-effikaċja u s-sikurezza tal-prodott f'pazjenti b'lewkimja mjelojde akuta fl-ewwel remissjoni ttrattata b'mod konkomitanti bl-interleukin-2 (IL-2).
English: 6.3 Shelf life
Maltese: 5.3 Tagħrif prekliniku tas-sigurtà
English: The recommended dosing regimen is presented in Tables 1 and 2.
Maltese: Ir-reġim tad-dożaġġ irrakkomandat huwa ppreżentat fit-Tabelli 1 u 2.