FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of romiplostim involved target-mediated disposition, which is presumably mediated by TPO receptors on platelets and other cells of the thrombopoietic lineage such as megakaryocytes.
Maltese: Il-farmakokinetika ta' romiplostim involviet dispożizzjoni medjata mit-targit, li preżumibbilment hija medjata minn riċetturi ta' TPO fuq plejtlits u ċelluli oħra ta' nisel trombopoetiku bħal megakarjoċiti.
English: All clinically significant (≥ grade 3) bleeding events occurred at platelet counts < 30 x 109/L.
Maltese: L-avvenimenti ta' fsada ta' sinifikanza klinika (≥ grad 3) kollha seħħew meta lgħadd tal-plejtlits kien ta' < 30 x 10
English: Oropharyngeal pain, upper abdominal pain, rhinitis, pharyngitis, conjunctivitis, ear infection, sinusitis and peripheral swelling were additional adverse reactions observed in paediatric studies compared to those seen in adult studies.
Maltese: Uġigħ fil-ħalq u fil-farinġi, uġigħ fil-part ta' fuq tal-addome, rinite, farinġite, konġuntivite, infezzjoni fil-widna, sinużite u nefħa periferali kienu reazzjonijiet avversi addizzjonali osservati fi studji pedjatriċi meta mqabbel ma' dawk osservati fi studji fl-adulti.
English: Pack size:
Maltese: Pakkett fih:
English: Thrombophlebitis superficial Thrombosis
Maltese: Tromboflebite superfiċjali Tromobożi
English: Do ensure that the plunger remains in the syringe.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: Overall, a significant greater proportion of subjects in the romiplostim arm achieved the primary endpoint compared with subjects in the placebo arm (p = 0.0018).
Maltese: B'mod globali, proporzjon akbar b'mod sinifikanti ta' individwu fil-grupp ta' romiplostim laħaq il-punt finali primarju meta mqabbel ma' individwi fil-grupp tal-plaċebo (p = 0.0018).
English: Eye pruritus
Maltese: Mhux korrett
English: • itching of the skin (pruritis);
Maltese: • ħakk fil-ġilda (prurite);
English: Preservative-free, sterile, sodium chloride 9 mg/mL (0.9%) solution for injection only must be used for dilution.
Maltese: Għad-dilwizzjoni għandha tintuża biss soluzzjoni għall-injezzjoni mingħajr preservattivi u sterili ta' 9 mg/mL (0.9%) sodium chloride.
English: The safety and efficacy of romiplostim was evaluated in two placebo-controlled, double-blind studies in adults with ITP who had completed at least one treatment prior to study entry and are representative of the entire spectrum of such ITP patients.
Maltese: Is-sigurtà u l-effikaċja ta' romiplostim kienu evalwati f'żewġ studji double-blind, ikkontrollati bilplaċebo f'adulti b'ITP li kienu temmew għall-inqas trattamenta wieħed qabel ma daħlu fl-istudju u huma rappreżentattivi tal-firxa kollha ta' pazjenti bħal dawn b'ITP.
English: Nplate 250 micrograms powder for solution for injection
Maltese: Nplate 250 mikrogramma trab għal soluzzjoni għall-injezzjoni
English: Weight* in kg x Dose in mcg/kg = Individual patient dose in mcg
Maltese: Piż* f'kg x Doża f'mcg/kg = Doża individwali tal-pazjent f'mcg
English: • Do ensure that the plunger remains in the syringe.
Maltese: • Terġax tuża oġġetti użati.
English: The potential interactions of romiplostim with co-administered medicinal products due to binding to plasma proteins remain unknown.
Maltese: L-interazzjonijiet potenzjali ta' romiplostim ma' prodotti mediċinali mogħtija fl-istess waqt minħabba rbit mal-proteini fil-plażma għadhom mhux magħrufa.
English: In adult clinical trials, romiplostim treatment was discontinued in 4 of the 271 patients because of bone marrow reticulin deposition.
Maltese: Fi provi kliniċi fl-adulti, trattament b'romiplostim twaqqaf f'4 mill-271 pazjent minħabba depożizzjoni ta' reticulin fil-mudullun tal-għadam.
English: Of the cases of MDS disease progression to AML that were observed, patients with RAEB-1 classification of MDS at baseline were more likely to have disease progression to AML compared to lower risk MDS.
Maltese: Minn dawk il-każijiet ta' MDS li pprogressaw għal AML, li kienu osservati, pazjenti bi klassifikazzjoni RAEB-1 ta' MDS fil-linja bażi kellhom aktar ċans li jkollhom progressjoni tal-marda għal AML meta mqabbla ma' MDS b'riskju anqas.
English: • muscle tightness; muscular weakness; shoulder pain; muscle twitching;
Maltese: • sintomi li jixbħu lill-influwenza (marda li tixbaħ lill-influwenza);
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Nplate in one or more subsets of the paediatric population in the treatment of immune thrombocytopenia (idiopathic thrombocytopenic purpura) (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddifferiet l-obbligu li jiġu ppresentati riżultati tal-istudji b'Nplate f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fil-kura ta' tromboċitopenija immuni (purpura tromboċitopenika idjopatika) (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku). 5.2 Tagħrif farmakokinetiku
English: Erythromelalgia
Maltese: Anġjoedima
English: Treatment with romiplostim resulted in statistically significantly greater incidence of platelet response compared with placebo (p = 0.0147).
Maltese: It-trattament b'romiplostim wassal għal inċidenza akbar statistikament sinifikanti ta' rispons tal-plejtlets meta mqabbel ma' plaċebo (p = 0.
English: Nplate 500 micrograms powder for solution for injection
Maltese: Nplate 500 mikrogramma trab għal soluzzjoni għall-injezzjoni
English: 9/L for 4 or more times during study weeks 2-25 but without durable platelet response.
Maltese: 9/L waqt ġimgħat 2-25 tal-istudju.
English: • bone marrow failure; disorder of the bone marrow that causes scarring (myelofibrosis); enlarged spleen (splenomegaly); bleeding of the vagina (vaginal haemorrhage), bleeding in the rectum (rectal haemorrhage); bleeding mouth (mouth haemorrhage); injection site bleeding (injection site haemorrhage);
Maltese: • insuffiċjenza tal-mudullun; disturb tal-mudullun li jikkawża ċikatriċi (mijelofibrożi); milsa kbira (splenomegalija); fsada mill-vaġina (emorraġija mill-vaġina), fsada mir-rektum (emorraġija mir-rektum); fsada mill-ħalq (emorraġija mill-ħalq); fsada mil-lok tal-injezzjoni fsada (emorraġija mil-lok tal-injezzjoni);
English: • abdominal pain;
Maltese: • spażmi fil-muskoli;
English: Nplate 250 micrograms powder for solution for injection should be reconstituted with 0.72 mL sterile water for injections, yielding a deliverable volume of 0.5 mL.
Maltese: Nplate 250 mikrogramma trab għal soluzzjoni għall-injezzjoni għandu jiġi rrikostitwit b'0.72 mL ilma sterili għall-injezzjonijiet, li jirriżulta f'volum li jista' jingħata ta' 0.5 mL.
English: For the storage condition after dilution of the reconstituted medicinal product see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: If individual patient dose is ≥ 23 mcg
Maltese: Jekk id-doża individwali tal-pazjent hija ≥ 23 mcg
English: There was also a stimulatory effect on leukocyte production, as peripheral blood counts for neutrophils, lymphocytes, monocytes, and eosinophils were mildly increased.
Maltese: Kien hemm ukoll effett stimulanti fuq ilproduzzjoni tal-lewkoċiti, peress li fid-demm fil-periferiji l-għadd ta' newtrofili, limfoċiti, monoċiti u esinofili kien kemxejn miżjud.
English: After dilution: Chemical and physical in-use stability has been demonstrated for 4 hours at 25ºC when the diluted product was held in a disposable syringe, or 4 hours in a refrigerator (2ºC - 8ºC) when the diluted product was held in the original vial.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu intweriet għal 4 sigħat f'temperatura ta' 25°C meta l-prodott dilwit kien miżmum f'siringa li tintuża darba u tintrema, jew 4 sigħat fi friġġ (2ºC - 8ºC) meta l-prodott dilwit kien miżmum fil-kunjett oriġinali.
English: Nplate 250 micrograms powder and solvent for solution for injection
Maltese: Nplate 250 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni
English: • raised white blood cell count (leucocytosis);
Maltese: • għadd miżjud taċ-ċelluli tad-demm bojod (lewkoċitosi);
English: The carcinogenic potential of romiplostim has not been evaluated.
Maltese: Il-potenzjal karċinoġeniku ta' romiplostim ma ġiex evalwat.
English: Nplate singleuse vial
Maltese: Jekk tieqaf tuża Nplate
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 4 hours at 25ºC in disposable syringes, or 4 hours in a refrigerator (2ºC - 8ºC) in the original vials, protected from light.
Maltese: Jekk ma jintużax immedjatament, iż-żminijiet ta' ħażna waqt l-użu u l-kondizzjonijiet qabel l-użu huma r responsabbiltà tal-utent u normalment ma jkunux itwal minn 4 sigħat f'temperatura ta' 25ºC f'siringi lijintużaw darba u jintremew, jew 4 sigħat fil-friġġ (2ºC - 8ºC) fil-kunjetti oriġinali, protetti mid-dawl.
English: • bone marrow disorder, including increased bone marrow fibres (reticulin);
Maltese: • disturb fil-mudullun tal-għadam, inkluż żieda fil-fibri tal-mudullun tal-għadam (reticulin);
English: • trouble sleeping (insomnia);
Maltese: • diffikultà biex torqod (insomnja);
English: • depression; abnormal dreams;
Maltese: • dipressjoni; ħolm mhux normali;
English: Skin odour abnormal Urticaria
Maltese: Bidla fil-kulur tas-snien
English: Vomiting
Maltese: Tromboċitosi
English: The subject prevalence of concurrent ITP medication use showed a trend towards a reduction over the course of the study: from 30.8% (weeks 1 to 12) to < 20.0% (weeks 13 to 240), and then 0% from week 240 to the end of the study.
Maltese: Il-prevalenza fl-individwi ta' użu ta' medikazzjoni għal ITP flistess waqt uriet tendenza lejn tnaqqis matul il-kors tal-istudju: minn 30.8% (ġimgħat 1 sa 12) għal < 20.
English: Pulmonary embolism* Cough Rhinorrhoea
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Hypoaesthesia Hypogeusia
Maltese: Kalculatur tal-pożoloġija
English: In the post-marketing registry study, 19 confirmed paediatric patients were included.
Maltese: Fl-istudju ta' reġistru wara t-tqegħid fis-suq, ġew inklużi 19-il pazjent pedjatriku ikkonfermat.
English: Injection site haemorrhage Chest pain
Maltese: Emorraġija fis-sit tal-injezzjoni Uġigħ fis-sider
English: Subject incidence was 1 (0.4%) for either grade ≥ 3 or serious thrombocytosis.
Maltese: L-inċidenza fl-individwi kienet ta' 1 (0.4%) għal tromboċitosi ta' grad ≥ 3 jew serja.
English: EU/1/08/497/006 - 1 pack
Maltese: EU/1/08/497/006 - pakkett wieħed
English: After subcutaneous administration of 3 to 15 mcg/kg romiplostim, maximum romiplostim serum levels in ITP patients were obtained after 7-50 hours (median 14 hours).
Maltese: Wara għoti taħt il-ġilda ta' 3 mcg/kg sa 15 mcg/kg ta' romiplostim, il-livelli massimi ta' romiplostim fis-serum f'pazjenti b'ITP intlaħqu wara 7-50 siegħa (medjan 14-il siegħa).
English: Across all subjects, the median (Q1, Q3) number of months with platelet response was 30.0 months (13.0 months, 43.0 months) and the median (Q1, Q3) time on study was 34.0 months
Maltese: Fost l-individwu kollha, in-numru medjan (Q1, Q3) ta' xhur b'rispons tal-plejtlets kien ta' 30.0 xahar (13.0-il xahar, 43.0 xahar) u ż-żmien medjan (Q1, Q3) tal-istudju kien ta' 34.0 xahar (24.0 xahar, 46.0 xahar).
English: Blood pressure increased Blood lactate dehydrogenase increased
Maltese: Żieda fil-pressjoni Żieda fil-lactate dehydrogenase fiddemm
English: Romiplostim is known to cross the placental barrier in rats and may be transmitted from the mother to the developing foetus and stimulate foetal platelet production.
Maltese: Romiplostim huwa magħruf li jgħaddi mill-barriera tal-plaċenta fil-firien u jista' jiġi trasferit mill-omm għall-fetu li qed jiżviluppa u jistimula l-produzzjoni tal-plejtlits fil-fetu.
English: • or cancer of white blood cells (multiple myeloma);
Maltese: • uġigħ jew debbulizza fil-muskoli (majalġja);
English: • Note: If your healthcare professional has instructed you that your Nplate dose requires more than one injection of Nplate, you will need to use more than one self injection kit.
Maltese: • Nota: Jekk il-professjonist fil-qasam mediku tiegħek għarfek li d-doża ta' Nplate tiegħek teħtieġ aktar minn injezzjoni waħda ta' Nplate, se jkollok bżonn tuża aktar minn kit waħda biex tinjetta lilek innifsek.
English: Bone marrow changes (increased reticulin and possible bone marrow fibrosis)
Maltese: Bidliet fil-mudullun tal-għadam (żieda f'reticulin u possibbilità ta' fibrożi fil-mudullun tal-għadam)
English: • Common: may affect up to 1 in 10 people
Maltese: • Komuni: jistgħu jaffettwaw sa persuna waħda minn kull 10
English: Romiplostim serum levels appear inversely related to platelet counts.
Maltese: Livelli ta' romiplostim fis-serum jidhru li huma relatati b'mod invers mal-għadd tal-plejtlits.
English: Gastro-oesophageal reflux disease
Maltese: Żbalji fl-Għoti tal-Mediċina
English: Transient platelet response was defined as weekly platelet count ≥ 50 x 10
Maltese: Rispons temporanju tal-plejtlits kien definit bħala għadd tal-plejtlits ta' kull ġimgħa ta' ≥ 50 x 10
English: • tingling or numbness of the hands or feet (paraesthesia);
Maltese: • tingiż jew tnemnim fl-idejn u s-saqajn (parasteżija);
English: Nplate is not recommended for use in children below age 18.
Maltese: Nplate mhux rakkomandat għall-użu fi tfal b'età inqas minn 18-il sena.
English: Reinitiate treatment with Nplate in accordance with dosing and administration recommendations (see sections 4.2 and 4.4).
Maltese: Erġa' ibda t-trattament b'Nplate skont irrakkomandazzjonijiet ta' dożaġġ u għoti (ara sezzjonijiet 4.2 u 4.4).
English: e Stable dose defined as dose maintained within ± 1 mcg/kg during the last 8 weeks of treatment.
Maltese: Doża stabbli hija definita bħala doża miżmuma f' ± 1 mcg/kg waqt l-aħħar 8 ġimgħat ta' trattament.
English: In a randomised placebo-controlled trial in MDS subjects, treatment with romiplostim was prematurely stopped due to a numerical excess of disease progression to AML and an increase in circulating blasts greater than 10% in patients receiving romiplostim.
Maltese: Fi prova randomised, ikkontrollata bilplaċebo, f'individwi b'MDS, trattament b'romiplostim kien imwaqqaf minn qabel minħabba numru eċċessiv ta' progressjoni tal-marda għal AML u żieda fi blasts li jiċċirkulaw ta' aktar minn 10% f'pazjenti li kienu qed jirċievu romiplostim.
English: No statistically significant differences in the overall incidence of bleeding events were observed between Nplate and placebo treated patients.
Maltese: Ma ġew osservati l-ebda differenzi statistikament sinifikanti flinċidenza globali ta' avvenimenti ta' fsada bejn pazjenti ttrattati bi Nplate u pazjenti ttrattati bilplaċebo.
English: Platelet count abnormal
Maltese: Newropatija periferali
English: Attach plunger rod to the pre-filled syringe of water for injections by twisting the plunger rod clockwise onto the syringe plunger, until you feel a slight resistance.
Maltese: Jekk it-tabib tiegħek ippermetta li tinjetta inti stess u tinsa tagħti l-injezzjoni lilek innifsek, għandek tgħarraf lit-tabib tiegħek immedjatament.
English: The initial dose of romiplostim is 1 mcg/kg based on actual body weight.
Maltese: Id-doża tal-bidu ta' romiplostim hija 1 mcg/kg abbażi tal-piż reali tal-ġisem.
English: For the storage condition after reconstitution of the product see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott, ara sezzjoni 6.3.
English: 9/L in between 50% to 70% of patients during the
Maltese: 9/L f'bejn 50% sa 70% tal-pazjenti waqt il-perjodu ta' trattament ta' 6 xhur fl-istudji kkontrollati bil-plaċebo.
English: • Step 3a: Attach clear plastic plunger rod to pre-filled sterile water syringe by placing the threaded end of the plunger rod into the syringe and carefully twisting the rod clockwise onto the grey syringe plunger, until you feel a slight resistance.
Maltese: • Kun ċert li l-parti ta' fuq tar-ras talplanġer tasal eżatt sal-marka fuq issiringa li taqbel mad-doża preskritta tiegħek.
English: Solvent for Nplate Water for injections
Maltese: Solvent għal Nplate Ilma għall-injezzjonijiet
English: • Withdraw the full amount of liquid into the syringe.
Maltese: • Għażel sit għall-injezzjoni.
English: A positive benefit/risk for romiplostim is only established for the treatment of thrombocytopenia associated with chronic ITP and romiplostim must not be used in other clinical conditions associated with thrombocytopenia.
Maltese: Mhux magħruf jekk romiplostim/metaboliti jiġix eliminat fil-ħalib tas-sider tal-bniedem.
English: EMEA/H/C/691
Maltese: EMEA/H/C/691 RAPPORT TA' VALUTAZZJONI
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00, Fax (44-20) 74 18 86 13 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged.
Maltese: (44-20) 74 18 84 00, Fax (44-20) 74 18 86 13 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged.
English: Other information about ZIMULTI:
Maltese: Informazzjoni oħra dwar ZIMULTI:
English: ZIMULTI is a medicine containing the active substance rimonabant.
Maltese: ZIMULTI hija mediċina li fiha s-sustanza attiva rimonbant.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ZIMULTI EPAR summary for the public
Maltese: PUBBLIKA EWROPEW (EPAR) ZIMULTI
English: The active substance in ZIMULTI, rimonabant, is a cannabinoid receptor antagonist.
Maltese: Is-sustanza attiva f'ZIMULTI rimonabant, hija antagonist tar-riċettur kannabinojde.
English: Caution should be used when taking ZIMULTI with some medicines, such as ketoconazole or itraconazole (anti-fungal medicines), ritonavir (used in HIV infection), or telithromycin or clarithromycin (antibiotics).
Maltese: Meta ŻIMULTI tittieħed ma' xi mediċini, bħalma huma, ketoconazole jew itraconazole (mediċini anti-fungali), ritonavir (użat f'infezzjoni HIV), jew telithromycin jew clarithromycin (antibijotiċi), għandha tintuża l-kawtela.
English: Why has ZIMULTI been approved?
Maltese: Għaliex ġiet approvata ZIMULTI?
English: • who are obese (very overweight) with a body mass index (BMI) greater than or equal to 30 kg/m²,
Maltese: • Li għandhom piż eċċessiv (ħafna piż żejjed) b'indiċi tal-massa korporja (BMI) akbar minn jew daqs 30kg/m²,
English: ZIMULTI is used together with diet and exercise to treat adult patients:
Maltese: ZIMULTI tintuża flimkien ma' dieta u eżerċizzju biex tikkura pazjenti adulti:
English: ©EMEA 2007
Maltese: Prodott mediċinali li m'għadux awtorizzat©EMEA 2007
English: What is the risk associated with ZIMULTI?
Maltese: X'inhu r-riskju assoċjat ma' ZIMULTI?
English: Patients who experience symptoms of depression should speak to their doctor and may need to stop treatment.
Maltese: Pazjenti li jesperjenzaw sintomi ta' depressjoni għandhom ikellmu lit-tabib tagħhom u jistgħu jeħtieġu li jwaqqfu lkura.
English: The effects of ZIMULTI were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' ZIMULTI għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma' ġew studjati filbniedem.
English: The company will use specific databases to monitor the side effects, especially those linked to the nervous system.
Maltese: Il-kumpanija se tuża databases speċifiċi biex tissorvelja l-effetti sekondarji ta' ZIMULTI, speċjalment dawk marbuta mas-sistema nervuża.
English: Four studies of ZIMULTI in overweight and obese patients were carried out, involving almost 7,000 patients, whose weight at the start of the studies was on average 94 to 104 kg. One study looked more particularly at patients with abnormal levels of blood fat, and one at patients with type 2 diabetes.
Maltese: Saru erba' studji ta' ZIMULTI f'pazjenti b'piż żejjed u piż eċċessiv, li involvew kważi 7,000 pazjent, li lpiż tagħhom fil-bidu ta' l-istudji kien medja ta' 94 sa 104kg.
English: This summary was last updated in 10-2007.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fl-10-2007.
English: The European Commission granted a marketing authorisation valid throughout the European Union for ZIMULTI to sanofi-aventis on 19 June 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni valida madwar l-Unjoni Ewropea kollha għal ZIMULTI lil sanofi aventis fid-19 ta' Ġunju 2006.
English: Four studies of ZIMULTI as a help to stop smoking were also carried out in over 7,000 patients, comparing it with placebo, and measuring the effect of the medicine given for 10 weeks (one year in one of the studies) on smoking cessation, and on relapses in the following year.
Maltese: Saru ukoll erba' studji ta' ZIMULTI bħala għajnuna biex jieqaf it-tipjip f'aktar minn 7,000 pazjent, u qabbluha ma' plaċebo, u kejlu l-effett tal-mediċina mogħtija għal 10 ġimgħat (sena f'wieħed mill-istudji) fuq it-twaqqif tat-tipjip, u fuq rikaduti fis-sena segwenti.
English: It must also not be used in patients with ongoing major depression or who are being treated with antidepressants, since it can increase the risk of depression, including thoughts about suicide in a small minority of patients.
Maltese: Ma tistax tintuża f'pazjenti b'depressjoni maġġura li għada fuqhom jew li jkunu qed jiġu ikkurati b' antidepressanti, peress li tista' żżid ir-riskju ta' depressjoni, inklużi ħsibijiet dwar suwiċidju f'minoranza żgħira ta' pazjenti.
English: What is ZIMULTI?
Maltese: X'inhi ZIMULTI?
English: During the studies, the most common side effects with ZIMULTI (seen in more than 1 patient in 10) were nausea (feeling sick) and infections of the upper respiratory tract.
Maltese: Waqt l-istudji, l-aktar effetti sekondarji komuni b'ZIMULTI (dehru f'aktar minn pazjent 1 minn kull 10) kienu nawżja (dardir) u infezzjonijiet tal-passaġġ respiratorju tan-naħa ta' fuq.
English: It is available as white, teardropshaped tablets.
Maltese: Tiġi bħala pilloli bojod, f'forma ovali.
English: After one year, all patients who received ZIMULTI lost more weight than those who received placebo: they lost on average 4.9 kg more than placebo, except in the study in diabetic patients, where the difference in the weight loss was 3.9 kg.
Maltese: Wara sena, il-pazjenti kollha li rċievew ZIMULTI tilfu aktar piż milli dawk li rċievew plaċebo: tilfu medja ta' 4.9kg aktar minn plaċebo, ħlief fl-istudju f'pazjenti dijabetiċi, fejn id-differenza fit-telf tal-piż kienet 3.9kg.
English: For the full list of all side effects reported with ZIMULTI, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji rrapportati b' ZIMULTI, ara l-Fuljett ta' Tagħrif.
English: It acts by blocking a specific type of receptors, the cannabinoid type 1 (CB1) receptors.
Maltese: Hija taħdem billi timblokka tip speċifiku ta' riċettur, ir-riċetturi kannabinojde (CBP) tip 1.
English: The medicine also reduced the risk of regaining weight.
Maltese: Il-mediċina naqqset ukoll ir-riskju ta' żieda ta' piż mill-ġdid.
English: The Committee decided that ZIMULTI's benefits are greater than its risks when used, in addition to diet and exercise, to treat obese patients and overweight patients with risk factors such as type 2 diabetes or dyslipidaemia.
Maltese: Il-Kumitat iddeċieda li l-benefiċċji ta' ZIMULTI huma akbar mir-riskji tagħha meta wżata, flimkien ma' dieta u eżerċizzju, biex tikkura f'pazjenti b'piż eċċessiv jew b'piż żejjed b' fatturi ta' riskju bħalma huma dijabete tip 2 jew dislipidimja.
English: How does ZIMULTI work?
Maltese: Kif taħdem ZIMULTI?
English: The company decided to withdraw its application for smoking cessation.
Maltese: Il-kumpanija iddeċiediet li tirtira l-applikazzjoni tagħha għal twaqqif tat-tipjip.
English: − Photosensitivity can only be prevented by avoiding exposure to the sun for 90 days after receiving the PhotoBarr injection
Maltese: − Fotosensittività tista' tiġi evitata billi ma jkunx hemm espożizzjoni għaxxemx għal 90 jum wara li tirċievi injezzjoni ta' PhotoBarr
English: − Brief background and introduction to Barrett's oesophagus and high grade dysplasia
Maltese: Gwida tal-pazjent − Sfont fil-qosor u introduzzjoni dwar l-esofagu ta' Barrett u displasja ta'