FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, indications in treatment of hepatoma/hepatocellular carcinoma, pain relief in patients with advanced, hormone-resistant prostate cancer (in combination with corticosteroids), reduction of neurologic disability and clinical relapses in secondary (chronic) progressive multiple sclerosis, treatment of blast crisis in (chronic) myeloid leukaemia and treatment of acute lymphocytic leukaemia are included in some of the MSs where Novantrone has a MA.
Maltese: Barra minn hekk, indikazzjonijiet fil-kura tal-karċinoma talepatoma/epatoċellulari, serħan mill-uġigħ f'pazjenti b'kanċer tal-prostata reżistenti għall-ormoni, avvanzat (f'kombinazzjoni mal-kortikosterojdi), tnaqqis ta' diżabilità newroloġika u rkadar kliniku fi sklerożi multipla progressiva sekondarja (kroniku), kura tal-blast crisis f'lewkimja majelojde (kronika) jew lewkimja limfotika akuta huma inklużi f'xi SM fejn Novantrone għandu MA.
English: In some member states, additional information was included on absence of interactions or pharmacokinetic and pharmacodynamic interactions without clinical relevance, this was not considered relevant to be included in the harmonised PI.
Maltese: F'xi Stati Membri, ġiet inkluża informazzjoni addizzjonali dwar in-nuqqas ta' interazzjonijiet jew interazzjonijiet farmakokinetiċi u farmakodinamiċi mingħajr rilevanza klinika, din ma kinitx meqjusa rilevanti li tkun inkluża fil-PI armonizzata.
English: Remission-induction treatment of blast crisis in chronic myeloid leukaemia, in combination regimen
Maltese: Kura ta' remissjoni-induzzjoni tal-blast crisis f'lewkimja majelojde kronika, fi skeda ta' kombinazzjoni
English: Treatment of acute lymphocytic leukaemia
Maltese: Kura ta' lewkimja limfotika akuta
English: In addition, due to the dose dependent risk of cardiotoxicity, the maximum lifetime cumulative dose was limited to 72 mg/m2.
Maltese: Barra minn hekk, minħabba r-riskju ta' dipendenza fuq id-doża ta' kardjotossiċità, id-doża kumulattiva tal-ħajja massima kienet limitata għal 72 mg/m2.
English: However, no benefit in overall survival or other clinically relevant endpoints has been reported.
Maltese: Madankollu, ma ġiex irrapportat benefiċċju fissopravivenza globali jew punti aħħarija klinikament rilevanti.
English: • The Committee considered that additional risk minimisation measures in the form of educational materials for the use of Novantrone and associated names in multiple sclerosis were necessary.
Maltese: • Il-Kumitat qies li kien hemm bżonn ta' miżuri ta' minimizzazzjoni tar-riskju addizzjonali fil-forma ta' materjal edukattiv għall-użu ta' Novantrone u ismijiet assoċjati fi sklerożi multipla.
English: Finally, warnings relative to the mutagenic potential, to the potential discoloration of urine and other tissues, to the risk of tumour lysis syndrome and contraception recommendations, risk of transient or persistent amenorrhea, present in some members states were considered relevant.
Maltese: Fl-aħħar nett, twissijiet relatati mal-potenzjal mutaġeniku, mat-telf tal-kulur potenzjali tal-awrina u ta' tessuti oħrajn, mar-riskju tas-sindrome tal-lysis tat-tumur u rakkomandazzjonijiet tal-kontraċezzjoni, riskju ta' amenorreja temporanja jew persistenti, li jinstabu f'xi Stati Membri tqiesu rilevanti.
English: Relevant information available on risks of infertility was also harmonised.
Maltese: Linformazzjoni rilevanti disponibbli dwar ir-riskji tal-infertilità kienet ukoll armonizzata.
English: This was accepted by the MAH which therefore withdrew it from the proposed harmonised PI.
Maltese: Din kienet aċċettata mill-MAH li għaldaqstant irtiraha mill-PI armonizzata proposta.
English: The data indicate an effect of mitoxantrone, in combination with corticosteroids, for the palliation (e.g. pain relief) of patients with advanced castrate-resistant prostate cancer (CRPC).
Maltese: Id-data tindika effett fuq mitoxantrone, f'kombinazzjoni ma' kortikosterojdi, għas-serħan mill-uġigħ ta' pazjenti b'kanċer tal-prostata reżistenti għall-kastrazzjoni (CRPC).
English: Other sections of the SmPC
Maltese: F'xi SM
English: There are currently three main indications, approved in all member states where Novantrone has a marketing authorisation (MA), with however divergences in their exact wording: treatment of metastatic breast cancer, treatment of non-Hodgkin's lymphoma, treatment of acute myeloid leukaemia (acute non-lymphocytic leukaemia).
Maltese: Bħalissa hemm tliet indikazzjonijiet ewlenin, approvati fl-Istati Membri kollha fejn Novantrone għandu awtorizzazzjoni għat-tqegħid fis-suq (MA), madankollu b'diverġenzi fil-formulazzjoni eżatta tal-kliem: kura kontra kanċer metastatiku tas-sider, kura tal-linfoma mhux ta' Hodgkin, kura ta' lewkimja majelojde akuta (lewkimja mhux limfotika akuta).
English: The MAH was asked to discuss the relevance of including four ADRs, which have been reported and are listed in the PI of other mitoxantrone-containing products.
Maltese: L-MAH intalab jiddiskuti r-rilevanza tal-inklużjoni tal-erba' ADRs, li kienu rrapportati u huma elenkati bil-PI ta' prodotti oħrajn li fihom mitoxantrone.
English: The CMHP followed the advice of the SAG and agreed on an operational definition for the indication in the harmonised product information.
Maltese: Is-CHMP segwa l-parir tasSAG u qabel dwardefinizzjoni operazzjonali għall-indikazzjoni fl-informazzjoni dwar il-prodott armonizzata.
English: The CHMP concluded that the level of evidence provided is limited.
Maltese: Is-CHMP ikkonkluda li l-livell tal-evidenza pprovduta huwa limitat.
English: Further it was considered that the interaction with immunosuppressive medicines should be mentioned.
Maltese: Barra minn hekk kien meqjus li l-interazzjoni mal-mediċini immunosuppressivi għandha tissemma'.
English: The standard contraindication in case of hypersensitivity to the active substance or any of the excipients (including sulphite, as already mentioned in some member states) was kept in the harmonised text.
Maltese: Il-kontraindikazzjoni standard f'każ ta' sensittività eċċessiva għas-sustanza attiva jew xi wħud milleċċipjenti (inkluż sulfit, kif imsemmi diġà f'xi stati membri) kienet miżmuma fit-test armonizzat.
English: The CHMP considered the clinical benefit of mitoxantrone demonstrated in adults and recommended the use of the term acute myeloid leukaemia rather than acute non-lymphocytic leukaemia.
Maltese: Is-CHMP qies il-benefiċċju kliniku ta' mitoxantrone muri fl-adulti u rrakkomanda l-użu tat-terminu lewkimja majelojde akuta minflok lewkimja mhux limfotika akuta.
English: For acute myeloid leukaemia dosing recommendations were proposed as a single agent in relapses and in combination as induction, consolidation and salvage therapy.
Maltese: Għal lewkimja majelojde akuta kienu proposti rakkomandazzjonijiet tad-doża bħala aġent waħdu fl-irkadar u f'kombinazzjoni bħala induzzjoni, konsolidazzjoni u terapija tas-salvataġġ.
English: As the harmonised indication is in the treatment of metastatic breast cancer, a warning in section 4.4 informing of the small risk of leukaemia and of the paucity of efficacy data in the adjuvant treatment of breast cancer was considered sufficient.
Maltese: Peress li l-indikazzjoni armonizzata hija fil-kura tal-kanċer metastatiku tas-sider, twissija fis-sezzjoni 4.4 li tinforma dwar ir-riskju żgħir ta' lewkimja u tan-nuqqas ta' data dwar l-effikaċja fil-kura awżiljarja tal-kanċer tas-sider kienet meqjusa biżżejjed.
English: Based on the data provided, the MAH was asked to add dysgeusia in the table listing the ARDs reported in oncology.
Maltese: Abbażi tad-data pprovduta, l-MAH intalab sabiex iżid id-disgewsja fit-tabella li telenka lARDs irrapportati fl-onkoloġija.
English: The CHMP also considered that in the table of ADR in multiple sclerosis the footnote specifying that the events amenorrhea may be consistent with premature menopause and that the causal relationship between the cases of sudden death and mitoxantrone administration is uncertain should be left in the harmonised PI.
Maltese: IsCHMP qies ukoll li fit-tabella tal-ADR fi sklerożi multipla, in-nota f'qiegħ il-paġna li tispeċifika li lavvenimenti ta' amenorreja jistgħu jkunu konsistenti ma' menopawża prematura u li r-relazzjoni kawżali bejn il-każijiet ta' mewt għall-għarrieda u l-għoti ta' mitoxantrone hija inċerta għandha titħalla fil-PI armonizzata.
English: These studies demonstrate the efficacy of mitoxantrone, in combination therapy, in the treatment of NHL.
Maltese: Dawn l-istudji juru l-effikaċja ta' mitoxantrone, f'terapija ta' kombinazzjoni, filkura tal-NHL.
English: The MAH recalculated the frequencies as per the SmPC guideline and included details of the most important adverse reactions.
Maltese: L-MAH reġa' kkalkula l-frekwenzi skont il-linja gwida tal-SmPC u inkluda dettalji tar-reazzjonijiet avversi l-aktar importanti.
English: In multiple sclerosis a flexible dosing schedule was agreed in order to reflect those used in clinical trials and practices in the different member states.
Maltese: Fl-isklerożi multipla kien hemm qbil dwar skeda ta' dożaġġ flessibbli sabiex tirrifletti dawk użati fil-provi u prattiki kliniċi fl-istati membri differenti.
English: Treatment of acute myeloid leukaemia
Maltese: L-MAH ipprovda diversi studji tal-fażi
English: These should be included in a risk management plan (RMP) with a particular focus on the use in multiple sclerosis to ensure a consistent minimum standard of management of the risks across MSs.
Maltese: Dawn għandhom ikunu inklużi fi pjan ta' ġestjoni tar-riskju (RMP) b'enfasi partikolari fuq l-użu fi sklerożi multipla sabiex jiżguraw standard minimu konsistenti ta' ġestjoni tar-riskji fl-Istati Membri kollha.
English: The CMHP followed this advice and considered that given their importance for the safe use of the product, the RMP and educational materials should be imposed as a condition to the MA while the study should be included in the RMP as a category 3.
Maltese: Is-CHMP segwa dan il-parir u qies li minħabba l-importanza tagħhom għall-użu sigur talprodott, l-RMP u l-materjali edukattivi għandhom ikunu imposti bħala kundizzjoni lill-MA filwaqt li listudju għandu jkun inkluż fl-RMP bħala kategorija 3.
English: The MAH provided a phase III study and several uncontrolled phase II studies in induction therapy as well as studies of mitoxantrone in combination regimens in relapsed/refractory ALL (including a study in children).
Maltese: II mhux ikkontrollati fit-terapija tal-induzzjoni kif ukoll studji ta' mitoxantrone fi skedi ta' kombinazzjoni f'ALL rikaduta/refrattarja (inkluż studju fit-tfal).
English: In addition, the increased thrombotic or haemorrhage risk with concomitant Vitamin K antagonists with tumoural disease, widely described in the literature was considered relevant to be added by the CHMP.
Maltese: Barra minn hekk, iżżieda fir-riskju trombotiku jew tal-emorraġija b'antagonisti tal-Vitamina K konkomittanti mal-mard tattumur, deskritt b'mod wiesa' fil-letteratura kienet meqjusa rilevanti għaż-żieda mis-CHMP.
English: In addition to those described above, warnings related to incorrect route of administration, to cardiac risks, risk of leukaemia and bone marrow/haematological monitoring recommendations, reduced immunological response to infection, secondary AML and MDS were considered acceptable with some amendments.
Maltese: Minbarra dawk deskritti hawn fuq, twissijiet relatati mal-modi mhux korretti ta' għoti, mar-riskji tal-qalb, mar-riskju tal-lewkimja u rakkomandazzjonijiet tal-monitoraġġ tal-mudullun/ematoloġiku, mar-rispons immunoloġiku mnaqqas għall-infezzjoni, mal-AML sekondarja u l-MDS kienu meqjusa aċċettabbli b'xi emendi.
English: The MAH's proposal including the fatal cases reported with overdosage was accepted with the addition of the types of toxicities observed and general recommended actions.
Maltese: Il-proposta talMAH inkluż il-każijiet fatali rrapportati b'doża eċċessiva kienet aċċettata biż-żieda tat-tipi ta' tossiċitajiet osservati u azzjonijiet irrakkomandati ġenerali.
English: Current guidelines for treatment of AML recommend an induction therapy with regimens containing an anthracycline (such as mitoxantrone) administered for 3 days and cytarabine administered for 7 days.
Maltese: Il-linji gwida attwali għall-kura tal-AML jirrakkomandaw terapija tal-induzzjoni bi skedi li fihom anthracycline (bħal mitoxantrone) mogħti għal 3 ijiem u cytarabine mogħti għal 7 ijiem.
English: • The Committee considered the identified divergences for Novantrone and associated names, for the indications, posology, contraindications, special warnings and precaution for use, as well as the remaining sections of the SmPC, labelling and package leaflet.
Maltese: • Il-Kumitat ikkunsidra d-diverġenzi identifikati għal Novantrone u ismijiet assoċjati, għallindikazzjonijiet, il-pożoloġija, il-kontraindikazzjonijiet, it-twissijiet speċjali u l-prekawzjoni għallużu, kif ukoll is-sezzjonijiet li jifdal tal-SmPC, it-tikkettar u l-fuljett ta' tagħrif.
English: Common dosing recommendations were proposed for metastatic breast cancer and non-Hodgkin's lymphoma including dose reduction guidance for use in combination therapy and in case of myelosuppression.
Maltese: Kienu proposti rakkomandazzjonijiet tad-doża komuni għal kanċer metastatiku tas-sider u limfoma mhux ta' Hodgkin inkluż gwida dwar it-tnaqqis fid-doża għall-użu f'terapija tal-kombinazzjoni u f'każ ta' majelosuppressjoni.
English: The MAH presented an overview of studies of mitoxantrone, mainly in patients with relapsing remitting and secondary progressive multiple sclerosis.
Maltese: L-MAH ippreżenta ħarsa ġenerali tal-istudji dwar mitoxantrone, prinċipalment f'pazjenti bi sklerożi multipla li tirkadi u tbatti u progressiva sekondarja.
English: Novantrone contains mitoxantrone, a synthetic anthracenedione antineoplastic agent that has a cytocidal effect on both proliferating and non-proliferating cultured human cells, suggesting activity against rapidly proliferating and slow-growing neoplasms.
Maltese: Bidliet introdotti fl-SmPC kienu riflessi b'mod konsistenti fit-tikkettar, madankollu ħafna mis-sezzjonijiet tħallew biex jimtlew fuq livell nazzjonali.
English: Although mitoxantrone is not one of the most frequently used chemotherapy regimens in NHL, the CHMP acknowledged that it could represent an alternative treatment option and considered the proposed harmonised wording acceptable.
Maltese: Għalkemm mitoxantrone mhuwiex waħda mill-iskedi ta' kimoterapija użata bl-aktar mod frekwenti fl-NHL, is-CHMP għaraf li jista' jirrapreżenta għażla tal-kura alternattiva u qies il-kliem armonizzat propost bħala aċċettabbli.
English: The CHMP was of the view that the scientific basis for this recommendation was weak and that information regarding vaccination schedule should rather be included in section 4.4 and 4.5, in line with clinical practice guidelines recommendations.
Maltese: Is-CHMP kien talfehma li l-bażi xjentifika għal din ir-rakkomandazzjoni kienet dgħajfa u li l-informazzjoni fir-rigward taliskeda tat-tilqima għandha tkun inkluż minflok fis-sezzjoni 4.4 u 4.5, skont ir-rakkomandazzjonijiet tallinji gwida tal-prattika klinika.
English: In order to effectively minimise these risk the CMHP considered that in addition to the MAH proposal to evaluate the LVEF prior to each dose of mitoxantrone in multiple sclerosis patients, it should also be monitored yearly for up to 5 years after the end of therapy and the maximum cumulative dose should not be exceeded.
Maltese: Sabiex jitnaqqsu dawn ir-riskji b'mod effettiv is-CHMP qies li flimkien mal-proposta tal-MAH sabiex jevalwa l-LVEF qabel kull doża ta' mitoxantrone f'pazjenti li jbatu minn sklerożi multipla, għandu jkun immonitorjat kull sena sa 5 snin wara t-tmiem tat-terapija u d-doża kumulattiva massima m'għandiex tinqabeż.
English: In the studies presented, albeit, limited in number and in heterogeneous populations, mitoxantrone demonstrated a consistent effect on relapses as well as disability.
Maltese: Fl-istudji ppreżentati, għalkemm limitati fin-numru u f'popolazzjonijiet eteroġenji, mitoxantrone wera effett konsistenti fuq l-irkadar kif ukoll id-diżabilità.
English: Palliation of non-resectable primary hepatocellular carcinoma
Maltese: Kura kontra kanċer metastatiku tas-sider
English: Pain relief in patients with advanced, castrate-resistant prostate cancer, in combination with corticosteroids
Maltese: Serħan mill-uġigħ f'pazjenti b'kanċer tal-prostata reżistenti għall-kastrazzjoni, avvanzat, f'kombinazzjoni mal-kortijosterojdi
English: The MAH presented four studies of mitoxantrone administered in combination with other cytostatic agents in the treatment of a blast crisis in chronic myeloid leukaemia.
Maltese: L-MAH ippreżenta erba' studji ta' mitoxantrone mogħti f'kombinazzjoni ma' aġenti ċitostatiċi oħrajn filkura ta' blast crisis f'lewkimja majelojde kronika.
English: EU/1/09/528/002 1 ml ampoules EU/1/09/528/001 3 ml ampoules
Maltese: EU/1/09/528/002 ampulli ta' 1 ml EU/1/09/528/001 ampulli ta' 3 ml
English: The active substance is caffeine citrate.
Maltese: Is-sustanza attiva hi caffeine citrate.
English: Alfasigma S.p.A., Via Enrico Fermi 1, Alanno (PE) Italy
Maltese: Alfasigma S.p.A., Via Enrico Fermi 1, Alanno (PE) L-Italja
English: 1.32 (0.81 to 2.14)
Maltese: 1.32 (0.81 sa 2.14)
English: 0.73 (0.57 to 0.94)
Maltese: 0.73 (0.57 sa 0.94)
English: This method is also known as “a drip”.
Maltese: Dan il-metodu huwa magħruf bħala “dripp”.
English: Caffeine is structurally related to the methylxanthines theophylline and theobromine.
Maltese: Caffeine huwa strutturalment relatat mal-methylxanthines theophylline u theobromine.
English: Each carton contains 10 ampoules.
Maltese: Kull kartuna fiha 10 ampulli.
English: Peyona contains sodium
Maltese: Peyona fih sodium
English: Solution for infusion Oral solution 10 ampoules
Maltese: Soluzzjoni orali 10 ampulli
English: 0.73 (0.52 to 1.03)
Maltese: 0.73 (0.52 sa 1.03)
English: Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, A-1010 Wien
Maltese: Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, A-1010
English: Date of first authorisation: 02/07/2009 Date of latest renewal: 03/03/2014
Maltese: Data tal-ewwel awtorizzazzjoni: 02/07/2009 Data tal-aħħar tiġdid: 03/03/2014
English: Chiesi S.A.S Tél: + 33 1 47688899
Maltese: Chiesi S.A. Tél: + 33 1 47688899
English: Via Enrico Fermi IT-65020 Alanno (PE) Italy
Maltese: Via Enrico Fermi IT-65020
English: Providens d.o.o.
Maltese: Providens d.o.o. Tel.:
English: Endotracheal tube
Maltese: Tubu endotrakejali
English: Dose of caffeine citrate (Volume)
Maltese: Doża ta'caffeine citrate (Volum)
English: Frequency is 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) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenza hija definita 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) u mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Gastrointestinal disorders Regurgitation, increased gastric aspirate, necrotising enterocolitis
Maltese: Regurġitazzjoni, gastric aspirate miżjud, enterokolite nekrotika
English: Irritability, jitteriness, restlessness, brain injury
Maltese: Irritabilità, nervożiżmu, aġitazzjoni,
English: Chemical and physical compatibility of the diluted solution has been demonstrated for 24 hours at 25ºC and at 2-8ºC.
Maltese: Il-kompatibilità kimika u fiżika tas-soluzzjoni dilwita ntweriet għal 24 siegħa f'temperatura ta' 25ºC u f'
English: Peyona contains the active substance caffeine citrate, which is a stimulant of the central nervous system, belonging to a group of medicines called methylxanthines.
Maltese: Peyona fih is-sustanza attiva caffeine citrate, li huwa stimulant tas-sistema nervuża ċentrali, u jagħmel parti minn grupp ta' mediċini msejħa methylxanthines.
English: Nervous system disorders Convulsion
Maltese: Disturbi fis-sistema nervuża Konvulżjoni
English: Cytochrome P450 1A2 (CYP1A2) is the major enzyme involved in the metabolism of caffeine in humans.
Maltese: Iċ-ċitokromju P450 1A2 (CYP1A2) huwa l-enżima prinċipali involuta fil-metaboliżmu ta' caffeine filbnedmin.
English: For storage conditions of the diluted medicinal product see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: There were more days without any apnoea under caffeine citrate treatment (3.0 days, versus 1.2 days for placebo; p=0.005); also, there was a higher percentage of patients with no apnoeas for > 8 days (caffeine 22% versus placebo 0%).
Maltese: Kien hemm aktar ġranet mingħajr l-ebda apneja taħt kura b'caffeine citrate (3.0 ijiem, kontra 1.2 jiem għall-plaċebo; p=0.005); barra dan, kien hemm persentaġġ ogħla ta' pazjenti bl-ebda apneja għal > 8 ijiem (caffeine 22% kontra plaċebo 0%).
English: CHIESI Farmaceutici SpA Via Palermo 26/A 43122 PARMA-ITALY
Maltese: CHIESI Farmaceutici SpA Via Palermo 26/A 43122 PARMA-ITALJA
English: Chiesi Farmaceutici S.p.A, Via Palermo 26/A, 43122 Parma, Italy
Maltese: Chiesi Farmaceutici S.p.A, Via Palermo 26/A, 43122 Parma, L-Italja
English: − very premature infants (< 28 weeks gestational age and/or body weight <1000 g) particularly when receiving parenteral nutrition
Maltese: − trabi prematuri ħafna (età ta' ġestazzjoni ta' < 28 ġimgħa u/jew piz tal-ġisem ta' <1000 g)
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol sodium (23 mg) f'kull doża, i.e. essenzjalment ‘mingħajr sodium'.
English: Inter-conversion between caffeine and theophylline has been reported in preterm newborn infants; caffeine levels are approximately 25% of theophylline levels after theophylline administration and approximately 3-8% of caffeine administered would be expected to convert to theophylline.
Maltese: Inter-konversjoni bejn caffeine u theophylline kienet irrapportata fi trabi tat-twelid li twieldu qabel iżżmien; livelli ta' caffeine huma madwar 25% tal-livelli ta' theophylline wara l-għoti ta' theophylline u madwar 3-8% ta' caffeine mogħti huwa mistenni li jinbidel f'theophylline.
English: This is the basis of caffeine's effect in apnoea of prematurity, for which several mechanisms have been proposed for its actions including: (1) respiratory centre stimulation, (2) increased minute ventilation, (3) decreased threshold to hypercapnia, (4) increased response to hypercapnia, (5) increased skeletal muscle tone, (6) decreased diaphragmatic fatigue, (7) increased metabolic rate, and (8) increased oxygen consumption.
Maltese: stimulazzjoni taċ-ċentru respiratorju, (2) żjieda fil-ventilazzjoni ta' kull minuta, (3) tnaqqis fil-limitu għal iperkapnija, (4) żjieda fir-rispons għal iperkapnija, (5) żjieda fit-ton tal-muskoli skeletriċi, (6) tnaqqis flgħeja tad-dijaframma, (7) żjieda fir-rata metabolika, u (8) żjieda fil-konsum ta' l-ossiġnu.
English: Route
Maltese: Rotta
English: In newborn infants, the t1/2 is approximately 3-4 days and the Ae is approximately 86% (within 6 days).
Maltese: Fi trabi tat-twelid, t1/2 hija madwar 3-4 ijiem u Ae hija madwar 86% (fi żmien 6 ijiem).
English: Citric acid monohydrate Sodium citrate Water for injections.
Maltese: Citric acid monohydrate Sodium citrate Ilma għall-injezzjonijiet.
English: Immune system disorders Hypersensitivity reaction
Maltese: Disturbi fis-sistema immuni Reazzjoni ta' sensittività eċċessiva
English: Caffeine's main action is as a CNS stimulant.
Maltese: L-azzjoni prinċipali ta' caffeine huwa bħala stimulant tas-CNS.
English: A recent large placebo-controlled multicentre study (n=2006) investigated short-term and long-term (18-21 months) outcomes of premature infants treated with caffeine citrate.
Maltese: Studju reċenti kbir ikkontrollat bil-plaċebo u multicentre (n=2006) investiga r-riżultati fuq perijodu qasir u fit-tul (18-21-il xahar) ta' trabi prematuri kkurati b'caffeine citrate.