FrancophonIA/ELRC3.0 huggingface dataset:
English: What is Restaysis?
Maltese: Kif jaħdem Restaysis?
English: Restaysis is a medicine that contains the active substance ciclosporin.
Maltese: Restaysis huwa mediċina li fih is-sustanza attiva ċiklosporina.
English: On 25 April 2018, Allergan Pharmaceuticals International Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Restaysis, for the treatment of moderate dry eye disease.
Maltese: Fil-25 ta' April 2018, Allergan Pharmaceuticals International Limited għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Restaysis, għall-kura tal-marda moderata tal-għajnejn xotti.
English: The active substance in Restaysis, ciclosporin, reduces the activity of cells of the immune system (the body's natural defences) that are involved in the processes that cause inflammation.
Maltese: Is-sustanza attiva f'Restaysis, iċ-ċiklosporina, tnaqqas l-attività fuq iċ-ċelloli tas-sistema immunitarja (id-difiżi naturali tal-ġisem) li huma involuti fil-proċessi li jikkawżaw infjammazzjoni.
English: What was Restaysis expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Restaysis?
English: Restaysis was expected to be used in adults with moderate dry eye disease that was inadequately controlled despite treatment with tear substitutes or eye lubricants.
Maltese: Restaysis kien mistenni li jintuża f'adulti b'marda moderata tal-għajnejn xotti li kienet ikkontrollata b'mod inadegwat minkejja t-trattament b'mediċina li tgħin fil-produzzjoni tad-dmugħ artifiċjali jew b'lubrikanti tal-għajnejn.
English: The company presented an analysis of the results from three studies with ciclosporin conducted in the 1990s in patients with moderate to severe dry eye disease, where Restaysis was compared with placebo (a dummy treatment).
Maltese: Is-CHMP ikkonkluda li r-riżultati ppreżentati mill-kumpanija ma kinux b'saħħithom biżżejjed biex juru li Restaysis huwa effettiv.
English: The analysis focused on a subgroup of patients with moderate dry eye disease.
Maltese: L-analiżi ffukat fuq sottogrupp ta' pazjenti bil-marda moderata tal-għajnejn xotti.
English: Applying it directly to the eye was expected to reduce inflammation and the symptoms of the disease.
Maltese: L-applikazzjoni tiegħu direttament fl-għajn kienet mistennija li tnaqqas l-infjammazzjoni u s-sintomi tal-marda.
English: Withdrawal of the marketing authorisation application for Restaysis (ciclosporin)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Restaysis (ċiklosporina)
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Restaysis could not have been approved for the treatment of moderate dry eye disease.
Maltese: Għalhekk, fiż-żmien tal-irtirar, is-CHMP kien tal-opinjoni li, minħabba n-nuqqas ta' effikaċja mixhuda, il-benefiċċji ta' Restaysis ma kinux jegħlbu r-riskji tiegħu.
English: The main measures of effectiveness were the number of patients with damaged eye surface and with blurred vision, after 6 months of treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien n-numru ta' pazjenti li kellhom ħsara fis-superfiċje tal-għajn u vista mċajpra, wara 6 xhur ta' kura.
English: In particular, the way the results were analysed in patients with moderate dry eye disease could have introduced a bias in favour of Restaysis.
Maltese: B'mod partikolari, il-mod ta' kif ġew analizzati r-riżultati f'pazjenti bil-marda moderata tal-għajnejn xotti jista' jkun li introduċa preferenza favur Restaysis.
English: 08757 Corbera de Llobregat (Barcelona) Spain
Maltese: 08757 Corbera de Llobregat (Barcelona) Spanja
English: Noventia Pharma srl Via Carlo PISACANE 31 I-47121 Forli (FC) Italy
Maltese: Noventia Pharma srl Via Carlo PISACANE 31 I-47121 Forli (FC)
English: Treatment*
Maltese: Trattament*
English: • Depression
Maltese: • Depressjoni
English: Method
Maltese: Metodu
English: • The active substance is histamine dihydrochloride.
Maltese: • Is-sustanza attiva hija histamine dihydrochloride.
English: Biotransformation/Elimination
Maltese: Bijotrasformazzjoni/Eliminazzjoni
English: IL-2 16 400 IU/kg followed by 0.5 mL Ceplene.
Maltese: IL-2 16 400 IU/kg segwit b'0.5 mL Ceplene.
English: For possible injection sites, see Figure 4.
Maltese: Għal punti tal-injezzjoni possibbli, ara l-Figura 4.
English: • Loss of appetite (anorexia)
Maltese: • Nuqqas ta' aptit (anoreksja)
English: w.4 to w.6 w.10 to w.12 w.16 to w.18
Maltese: ġ. 4 sa ġ.6 ġ.10 sa ġ.12 ġ.16 sa ġ.18
English: Week number (w)*
Maltese: Ġimgħa numru (ġ)*
English: • Beta-blockers, such as propranolol, metoprolol, atenolol.
Maltese: • Imblokkaturi Beta, bħal propranolol, metoprolol, atenolol.
English: Standard dosage (µg)
Maltese: Dożaġġ stàndard (µg)
English: C/ Casanova, 27-31
Maltese: Labiana Pharmaceuticals, S.L.U. C/ Casanova, 27-31
English: w.58
Maltese: ġ.58
English: 20% dose reduction injection volume (mL)**
Maltese: Volum tal-injezzjoni bi tnaqqis ta' 20% fid-doża (mL)**
English: • Steroids such as prednisone and dexamethasone.
Maltese: • Sterojdi bħal prednisone u dexamethasone.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Maltese: IDENTIFIKATUR UNIKU - DEJTA LI TISTA' TINQARA MILL-BNEDMIN
English: Frequencies are defined as very common ( 1/10), common ( 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), or not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma ddefiniti bħala komuni ħafna ( 1/10), komuni ( 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), jew mhux magħrufa (ma jistgħux jiġu stmati mid-data disponibbli).
English: • narrowing of the arteries (systemic peripheral arterial disease),
Maltese: • tidjiq tal-arterji (mard arterjuż periferiku sistemiku),
English: The main enzymes involved in the metabolism of histamine are HNMT (histamine-N-methyltransferase) and DAO (diamine oxidase).
Maltese: L-enzimi ewlenin involuti fil-metaboliżmu ta' histamine huma HNMT (histamine-N-methyltransferase) u DAO (diamine-oxidase).
English: Very common depression
Maltese: Komuni ħafna depressjoni
English: However, this difference was not statistically significant.
Maltese: Madankollu, din id-differenza ma kinitx statistikament sinifikanti.
English: Content of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: • Certain anti-psychotics such as chlorpromazine, flupenthixol, thoridazine, clozapine and risperidone.
Maltese: • Ċerti antipsikotiċi bħal chlorpromazine, flupenthixol, thoridazine, clozapine u risperidone.
English: Metabolism and nutrition disorders anorexia
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni anoreksja
English: to w.81
Maltese: sa ġ.81
English: w.31
Maltese: ġ.31
English: to w.48
Maltese: sa ġ.48
English: w.7 to w.9 (Days 1-21)
Maltese: ġ.7 sa ġ.9 (Jiem 1-21)
English: 1 prepared syringe containing Ceplene.
Maltese: Iddeċiedi fejn se tinjetta Ceplene.
English: w.13 to w.15 (Days 1-21)
Maltese: ġ.13 sa ġ.15 (Jiem 1-21)
English: • bleeding ulcers,
Maltese: • ulċeri bid-demm,
English: • Tricyclic antidepressant medicines such as amitryptiline, imipramine, or monoamine oxidase inhibitors, such as phenelzine, isocarboxazide, tranylcypromine or moclobemide.
Maltese: • Antidepressivi triċikliċi bħal amitryptiline, imipramine, jew inibituri ta' monoamine oxidase, bħal phenelzine, isocarboxazide, tranylcypromine jew moclobemide.
English: to w.66
Maltese: sa ġ.66
English: • Nausea, indigestion (dyspepsia) and diarrhoea
Maltese: • Nawżea, indiġestjoni (dispepsija) u dijarrea
English: *Injection volume rounded up to the nearest 0.05 mL ** Injection volumes based on 20% reductions are rounded thus actual dose reductions vary from 15%-25%
Maltese: *Volum tal-injezzjoni jiġi mnaqqas/miżjud lejn l-eqreb 0.05 mL ** Volumi tal-injezzjoni bbażati fuq tnaqqis ta' 20% jiġu mnaqqsa/miżjuda u għalhekk tnaqqis fid-doża attwali tvarja minn 15% -25%
English: See section 4.
Maltese: Ara sezzjoni 4..
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).
Maltese: IL-2 (aldesleukin) dilwit jiġi miġbud b'mod asettiku f'siringi sterili ta' tuberculin magħmula minn polypropylene u magħluqa b'tapp għal kull pazjent f'doża ta' 1 µg/kg, b'volum ta' dożaġġ stàndard minimu ta' 0.25 mL (50 µg) u doża massima ta' 0.5 mL (100 µg).
English: • Any treatment for high blood pressure (for example thiazide diuretics [bendrofluazide], ACE inhibitors [captopril], calcium antagonists [nifedipine] and alpha-blockers [prazosin]).
Maltese: • Kwalunkwe trattament kontra l-ipertensjoni (pereżempju diuretiċi thiazide [bendrofluazide], ACE-inibituri [captopril], antagonisti tal-kalċju [nifedipine] u imblokkaturi alpha [prazosine].
English: - Clonidine, a medicine used to reduce high blood pressure.
Maltese: - Klonidina (clonidine), mediċina użata għat-tnaqqis tal-pressjoni għolja.
English: w.55to w.57
Maltese: ġ. 55 sa ġ.57
English: - IL-2 can be discontinued for 24 hours and then restarted at a 20% dose reduction level.
Maltese: - IL-2 jista' jiġi sospiż għal 24 siegħa u mbagħad jerġa' jinbeda f'livell ta' tnaqqis ta' 20% tad-doża.
English: Table 3: Administration chart for IL-2 (aldesleukin)
Maltese: Tabella 3: Tabella għall-għoti ta' IL-2 (aldesleukin)
English: Musculoskeletal and connective tissue disorders arthralgia, myalgia
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi artralġja, mijalġja
English: Figure 1
Maltese: Figura 1
English: to w.21
Maltese: sa ġ.21
English: w.49
Maltese: ġ.49
English: to w.75
Maltese: sa ġ.75
English: The pharmacokinetics of histamine are similar in healthy volunteers with normal renal function compared to volunteers with mild, moderate, or severe renal impairment.
Maltese: Il-farmakokinetika tal-istamina hija simili f'voluntiera f'saħħithom b'funzjoni renali normali meta mqabbla ma' voluntiera b'insuffiċjenza renali, ħafifa, moderata, jew severa.
English: Table 1: For treatment cycles 1-3 with Ceplene and IL-2
Maltese: Tabella 1: Għaċ-ċikli ta' trattament b'Ceplene u IL-2
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - 2D BARCODE
English: Each mark (0.1, 0.2, 0.3, etc.) represents one-tenth of a millilitre (0.1 mL).
Maltese: Kull marka (0.1, 0.2, 0.3, etc.) tirrappreżenta wieħed minn kull għaxra ta' millilitru (0.1 mL).
English: w.76
Maltese: ġ.76
English: Cycles w.19
Maltese: Ċikli ġ.19
English: Treatment-free (6 weeks)
Maltese: Mingħajr trattament (6 ġimgħat)
English: to w.54
Maltese: sa ġ.54
English: Endocrine disorders hypothyroidism
Maltese: Disturbi fis-sistema endokrinarja ipotirojdiżmu
English: to w.72
Maltese: sa ġ.72
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
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).
Maltese: Antagonisti tar-riċetturi H2 bi strutturi imidazole simili għall-istamina, pereżempju, ċimetidina (cimetidine), sterojdi sistemiċi u klonidina, ma għandhomx jintużaw waqt trattament b'Ceplene (ara sezzjoni 4.3).
English: • Patients receiving systemic steroid therapy, clonidine and H2 blocking agents.
Maltese: • Pazjenti li qegħdin jirċievu terapija sistemika bi sterojdi, klonidina (clonidine) u mediċini li jimblokkaw H2.
English: to w.39
Maltese: sa ġ.39
English: Ear and labyrinth disorders vertigo
Maltese: Disturbi fil-widnejn u fissistema labirintika vertigo
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.
Maltese: Ceplene u doża baxxa ta' IL-2 ġew investigati fi studji kliniċi oħrajn f'dożi differenti (1 mg ta' histamine dihydrochloride darbtejn kuljum) u b'reġim ta' dożi differenti ta' doża baxxa ta' IL-2 u interferon-alfa.
English: • stroke,
Maltese: • puplesija,
English: Gastrointestinal disorders constipation, abdominal distention, stomatitis
Maltese: Disturbi gastrointestinali stitikezza, nefħa addominali, stomatite
English: - Neuromuscular blocking agents, narcotic analgesics, and various contrast media.
Maltese: - Mediċini imblokkaturi newromuskolari, analġeżiċi narkotiċi, u diversi mezzi ta' kuntrast.
English: • Inflammation of the lung (pneumonia)
Maltese: • Infjammazzjoni tal-pulmun (pulmonite)
English: to w.36
Maltese: sa ġ.36
English: Psychiatric disorders insomnia
Maltese: Disturbi psikjatriċi insomnija
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).
Maltese: Konċentrazzjonijiet tal-istamina fil-plażma kienu ferm varjabbli u kienu konsiderevolment ogħla fi gruppi ta' pazjenti b'insuffiċjenza epatika ħafifa, moderata jew gravi (medjani 10 u 5 darbiet il-voluntiera normali, rispettivament).
English: to w.45
Maltese: sa ġ.45
English: >50 to ≤60 >60 to ≤70 >70 to ≤80 >80 to ≤90 >90 to ≤100
Maltese: >60 sa ≤70
English: to w.63
Maltese: sa ġ.63
English: Figure 5
Maltese: Figura 5
English: w.73
Maltese: ġ.73
English: *see dose modification for provisions for the modification to dose and dosage schedule
Maltese: *ara modifika tad-doża għad-dispożizzjonijiet għall-modifika tad-doża u tal-programm taddożaġġ
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).
Maltese: Il-prova tal-fażi 3 randomizzata (0201) qabblet it-trattament b'Ceplene+IL-2 ma' ebda trattament f'261 pazjent fl-ewwel remissjoni (CR1) u 59 pazjent oħra f'remissjoni wara rikaduta sussegwenti (CR>1).
English: w.67
Maltese: ġ.67
English: One to 3 minutes after the subcutaneous administration of IL-2 has been completed, Ceplene should be administered by slow subcutaneous injection at a rate not to exceed 0.1 mL (0.1 mg histamine dihydrochloride) per minute.
Maltese: Minuta sa 3 minuti wara li jintemm l-għoti taħt il-ġilda ta' IL-2, Ceplene għandu jingħata bil-mod b'injezzjoni taħt il-ġilda f'rata li ma taqbiżx 0.1 mL (0.1 ml ta' histamine dihydrochloride) kull minuta.
English: Ceplene must be injected 1 to 3 minutes after IL-2.
Maltese: Ceplene jingħata minn minuta sa 3 minuti wara kull injezzjoni ta' IL-2.
English: Inject slowly over a period of 5-15 minutes.
Maltese: Injetta bil-mod fuq perjodu ta' 5-15-il minuta.
English: A maximum delay of one treatment cycle can be considered for the resolution of grade 3 and 4 events.
Maltese: Ittardjar massimu ta' ċiklu wieħed ta' trattament jista' jiġi kkunsidrat għar-riżoluzzjoni ta' episodji ta' grad 3 u 4.
English: w.37
Maltese: ġ.37
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.
Maltese: Ir-reazzjonijiet avversi kkunsidrati tal-inqas possibbilment relatati ma' trattament b'IL-2 f'doża baxxa ma' Ceplene fi studji AML (n=280 għall-fergħa tat-trattament IL-2 u Ceplene) huma elenkati hawn taħt skont is-sistema ta' klassifikazzjoni tal-organi tal-ġisem, klassi u frekwenza.
English: Pharmacotherapeutic group: Immunostimulants, other immunostimulants, ATC code: L03AX14.
Maltese: Immunostimulanti, immunostimulanti oħra, Kodiċi ATC:
English: w.64
Maltese: ġ.64
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertilità, tqala u Treddigħ
English: There are no data available on pharmacodynamic properties in children below 18 years of age.
Maltese: M'hemmx dejta disponibbli dwar il-proprjetajiet farmakodinamiċi fi tfal b'età inqas minn 18-il sena.
English: Detailed information on this medicine is available on the European Medicine Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinstab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
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).
Maltese: In-numru ta' pazjenti CR1 li baqgħu mingħajr lewċemija għal 3 snin kien ta' 40% wara Ceplene+IL-2 meta mqabbel 26% f'pazjenti li ma kinux qegħdin jirċievu dan it-trattament (p=0.01).
English: Patient weight (kg)
Maltese: Piż tal-pazjent (kg)
English: Ceplene 0.5 mg/0.5 mL solution for injection
Maltese: Ceplene 0.5 mg/0.5 mL soluzzjoni għall-injezzjoni
English: • Flushing
Maltese: • Fwawar
English: See Figure 2.
Maltese: Ara l-Figura 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).
Maltese: Kunjetti tal-ħġieġ tat-tip I ta' 2 mL, b'tapp ta' lastiku bromobutil u siġill ta' fuqu tal-aluminju li jinqala', li fih 0.5 mL soluzzjoni (0.70 mL inkluża l-parti mfawra).
English: Dose modification
Maltese: Modifika tad-doża
English: Ceplene is indicated for use in adults.
Maltese: Ceplene huwa indikat għall-użu fl-adulti.
English: Nervous system disorders paraesthesia
Maltese: Disturbi fis-sistema nervuża parasteżija
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.
Maltese: Il-mekkaniżmu li bih Ceplene itejjeb il-funzjoni antilewċemika tal-linfoċiti f'AML mhuwiex kompletament stabbilit; huwa kkunsidrat li jsir permezz ta' inibizzjoni ta' speċijiet reattivi tal-ossiġenu (ROS jew "radikali liberi tal-ossiġenu"), li huma sintetizzati mill-monoċiti/makrofaġi u granuloċiti.
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).
Maltese: IL-2 (aldesleukin) għandu jiġi rikostitwit, dilwit u mqassam b'mod asettiku f'siringi ta' tuberculin magħmula minn polypropylene u magħluqa b'tapp mill-ispiżerija bbażat fuq il-piż tal-pazjent individwali (ara t-tabella tal-għoti għal aldesleukin taħt) fid-doża rrakkomandata ta' 16 400 IU/kg (1 μg/kg).
English: How to store Ceplene
Maltese: Tużax Ceplene
English: Ceplene 0.5 mg/0.5 mL solution for injection histamine dihydrochloride
Maltese: Ceplene 0.5 mg/0.5 mL soluzzjoni għall-injezzjoni histamine dihydrochloride
English: No clinical data are available on the effects of Ceplene on fertility.
Maltese: M'hemmx dejta klinika dwar l-effetti ta' Ceplene fuq il-fertilità.
English: Figure 7
Maltese: Figura 7
English: 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.
Maltese: Ir-rekwiżiti għas-sottomissjoni ta' rapporti dwar aġġornamenti perjodiċi tas-sikurezza għal dan ilprodott mediċinali huma stabbiliti fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) stipulati taħt l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku tal-mediċini Ewropej.
English: Wait 1 to 3 minutes.
Maltese: 3. Stenna bejn minuta u 3 minuti.
English: w.46
Maltese: ġ.46
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.
Maltese: Għal pazjenti CR1, it-tul ta' żmien medjan ta' sopravivenza mingħajr lewċemija żdied minn 291 jum (9.7 xhur) għal 450 jum (15-il xahar) wara Ceplene/IL-2 meta mqabbal ma' ebda trattament ta' manteniment (Intenzjoni għat-Trattament [ITT], p=0.01. n=261).
English: to w.27
Maltese: sa ġ.27
English: Ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia (AML) in first remission concomitantly treated with interleukin-2 (IL-2).
Maltese: Ceplene huwa indikat bħala terapija ta' manteniment għall-pazjenti adulti li jbatu minn lewċemija mjelojde akuta (AML - acute myeloid leukaemia) fl-ewwel remissjoni ttrattata fl-istess ħin b'interleukin-2 (IL-2).
English: Histamine is eliminated by metabolism in kidney, liver and other tissues.
Maltese: Histamine huwa eliminat permezz ta' metaboliżmu fil-kliewi, fwied u tessuti oħrajn.
English: • H2 blockers such as cimetidine, ranitidine, famotidine or nizatidine.
Maltese: • Imblokkaturi H2-blockers bħal ċimetidina (cimetidine), ranitidina (ranitidine), famotidina (famotidine) jew nizatidina (nizatidine).
English: Figure 6
Maltese: Figura 6
English: Figure 3
Maltese: Figura 3
English: Interleukin-2 (IL-2) is commercially available as a recombinant IL-2; aldesleukin.
Maltese: Interleukin-2 (IL-2) huwa disponibbli b'mod kummerċjali bħala IL-2 rikombinanti; aldesleukin.
English: Treatment-free (3 weeks) *see dose modification for provisions for the modification to dose and dosage schedule
Maltese: Mingħajr trattament (3 ġimgħat) *ara modifika tad-doża għall-proviżjoni għall-modifika tad-doża u l-iskeda tad-dożaġġ
English: Figure 4
Maltese: Figura 4
English: Remain seated or lying down for 20 minutes after injecting Ceplene.
Maltese: Il-pazjenti għandhom jibqgħu mistrieħa għal 20 minuta wara injezzjoni ta' Ceplene.
English: ANNEX III
Maltese: III/IV.
English: For patients experiencing grade 2 (including cardiac function, renal, hepatic) toxicity - treatment should be discontinued until the event has returned to grade 1 - the time of injection of the dose of Ceplene should be extended to a maximum of 15 minutes.
Maltese: Għal pazjenti li qegħdin jesperjenzaw tossiċità ta' grad 2 (inklużi funzjoni kardijaka, renali, epatika) - it-trattament għandu jieqaf sakemm l-episodju jirritorna għal grad 1 - il-perjodu tal-injezzjoni tad-doża ta' Ceplene għandu jittawwal sa massimu ta' 15-il minuta.
English: This medicine has been authorised under ‘exceptional circumstances'.
Maltese: Dan il-prodott mediċinali kien awtorizzat taħt ‘ċirkustanzi eċċezzjonali'.
English: Slightly pull back the plunger.
Maltese: Iġbed il-plunger ftit lura.
English: Ceplene is available in pack sizes of 14 vials.
Maltese: Ceplene huwa provdut f'pakketti ta' 14-il kunjett.
English: The safety and efficacy of Ceplene in children below 18 years of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Ceplene fi tfal taħt l-età ta' 18-il sena ma ġewx determinati s'issa.
English: Monitoring of laboratory test results is recommended including standard haematological and blood chemistry tests.
Maltese: Hija rrakkomandata sorveljanza ta' riżultati ta' testijiet tal-laboratorju inklużi testijiet standard ematoloġiċi u ematokimiċi.
English: • Sensation of spinning (vertigo)
Maltese: • Rasek iddur bik (vertigo)
English: For cycles 4-10, each cycle consists of 3 weeks of treatment, followed by a 6-week treatment free period.
Maltese: Għaċ-ċikli 4-10, kull ċiklu jikkonsisti minn 3 ġimgħat ta' trattament, segwiti minn perjodu mingħajr trattament ta' 6 ġimgħat.
English: Infections and infestations upper respiratory tract infections
Maltese: Infezzjonijiet u infestazzjonijiet infezzjonijiet fl-apparat respiratorju ta' fuq
English: See Figure 7.
Maltese: Ara l-Figura 7.