FrancophonIA/ELRC3.0 huggingface dataset:
English: • Following a review of the available data, EMA has confirmed the risk of pneumonia with inhaled corticosteroids (ICS) in patients with COPD.
Maltese: • Wara rieżami tad-data disponibbli, l-EMA kkonfermat ir-riskju ta' pulmonite b'kortikosterojdi li jittieħdu man-nifs (ICS) f'pazjenti li jbatu minn COPD. Ma hemm l-ebda evidenza klinika konklussiva għal differenzi ġewwa l-klassi fid-daqs tar-riskju fost prodotti li fihom ICS.
English: • It has been known for some time that inhaled corticosteroid medicines increase the risk of pneumonia (infections of the lungs) in patients taking these medicines for the long-term lung disease COPD (chronic obstructive pulmonary disease).
Maltese: • Ilu magħruf għal xi żmien li l-mediċini kortikosterojdi li jittieħdu man-nifs iżidu r-riskju talpulmonite (infezzjoni tal-pulmun) f'pazjenti li jieħdu dawn il-mediċini għall-marda tal-pulmun fit-tul COPD (marda pulmonari ostruttiva kronika).
English: Diverticulitis.
Maltese: Divertikulite.
English: 17498 Mesekenhagen Germany or
Maltese: 17498 Mesekenhagen
English: • Iodine salts and/or levothyroxine.
Maltese: • Imluħa ta' iodine u/jew levothyroxine.
English: • Anticoagulant drugs (e.g. warfarin).
Maltese: • Mediċini kontra l-koagulazzjoni (eż. warfarin).
English: It may harm them,
Maltese: Distubi ġinġivali
English: For a full list of excipients, see 6.1.
Maltese: Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: - Chronic malabsorption syndrome.
Maltese: - Sindrome kronika ta' assorbiment ħażin.
English: INFORMATION IN BRAILLE xenical
Maltese: INFORMAZZJONI BIL-BRAILLE xenical
English: CHEPLAPHARM Arzneimittel GmbH Bahnhofstr.
Maltese: Arzneimittel GmbH Bahnhofstr.
English: CHEPLAPHARM Arzneimittel GmbH Ziegelhof 23-24
Maltese: Arzneimittel GmbH Ziegelhof 23-24
English: Capsule filling: microcrystalline cellulose (E460) sodium starch glycolate (type A) povidone (E1201) sodium laurilsulfate talc
Maltese: Mili fil-kapsula: microcrystalline cellulose (E460) sodium starch glycolate (tip A) povidone (E1201) sodium laurilsulfate talkum
English: No interactions with amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, phentermine, pravastatin, nifedipine Gastrointestinal Therapeutic System (GITS), nifedipine slow release, sibutramine or alcohol have been observed.
Maltese: Ma ġewx osservati interazzjonijiet ma' amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, phentermine, pravastatin, Sistema Terapewtika Gastro-intestinali (GITS - Gastrointestinal Therapeutic System) ta' nifedipine, nifedipine b'rilaxx bil-mod, sibutramine jew alkoħol.
English: PVC/ PVDC blisters containing 21, 42 and 84 hard capsules.
Maltese: Folji tal-PVC/PVDC li fihom 21, 42 u 84 kapsula iebsa.
English: This can lead to a decrease of immunosuppressive efficacy.
Maltese: Dan jista' jwassal għal tnaqqis ta' effikaċja immunosoppressiva.
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) and very rare (<1/10,000) including isolated reports.
Maltese: (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000) u rari ħafna (<1/10,000) inkluż rapporti iżolati.
English: In orlistat-treated patients, the mean difference from placebo in weight loss was 1.83 kg to 3.06 kg and the mean difference from placebo in HbA1c reduction was 0.18 % to 0.55 %.
Maltese: F'pazjenti kkurati b'orlistat, id-differenza medja mill-plaċebo fit-tnaqqis tal-piż kienet 1.83 kg sa 3.06 kg u d differenza medja mill-plaċebo fit-tnaqqis ta' HbA1c kienet 0.18 % sa 0.55 %.
English: Reproductive system and breast disorders Common: Menstrual irregularity
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Komuni: Mestrwazzjoni irregolari
English: Pharmaco-therapeutic group: Peripherally acting antiobesity agent, ATC code A08AB01.
Maltese: Sustanza kontra l-ħxuna żejda li taħdem fil-periferija, Kodiċi ATC A08AB01.
English: In vitro orlistat is > 99 % bound to plasma proteins (lipoproteins and albumin were the major binding proteins).
Maltese: Orlistat in vitro huwa > 99 % marbut ma' proteini tal-plażma (lipoproteini u albumina kienu l-aktar proteini li jintrabtu).
English: Capsule shell: gelatine indigo carmine (E132) titanium dioxide (E171) edible printing ink (black iron oxide, ammonia solution concentrated, potassium hydroxide, shellac, propylene glycol)
Maltese: Qoxra tal-kapsula: gelatine indigo karminju (E132) titanium dioxide (E171) linka li tista' tittiekel għall-istampar (iron oxide iswed, soluzzjoni konċentrata ta' ammonia, potassium hydroxide, shellac, propylene glycol)
English: See Chapter 2, take special care with Xenical.
Maltese: Ara Kapitlu 2, Oqgħod attent/a ħafna b'Xenical.
English: The following table of undesirable effects is based on post-marketing spontaneous reports, and therefore the frequency remains unknown:
Maltese: It-tabella ta' effetti mhux mixtieqa li ġejja hi bbażata fuq rapporti spontanji wara t-tqegħid fis-suq, u għalhekk il-frekwenza għadha mhix magħrufa:
English: Rectal bleeding Diverticulitis Pancreatitis
Maltese: Fsada mir-rektum Divertikulite Pankreatite
English: In a multi-centre (US, Canada), parallel-group, double-blind, placebo-controlled study, 539 obese adolescent patients were randomised to receive either 120 mg orlistat (n=357) or placebo (n=182) three times daily as an adjunct to a hypocaloric diet and exercise for 52 weeks.
Maltese: Fi studju b'aktar minn ċentru wieħed (US u Kanada), bi grupp parallel, double-blind, ikkontrollat bil plaċebo, 539 pazjenti adolexxenti ħoxnin iżżejjed kienu randomised biex jirċievu 120 mg orlistat (n=357) jew plaċebo (n=182) tliet darbiet kuljum bħala żieda ma' dieta ta' kaloriji baxxi u eżerċizzju għal 52 ġimgħa.
English: Approximately 97 % of the administered dose was excreted in faeces and 83 % of that as unchanged orlistat.
Maltese: Madwar 97 % tad-doża li tkun ingħatat tneħħiet mal-ippurgar u 83 % minn dan kien orlistat mhux mibdul.
English: Increase in liver transaminases and in alkaline phosphatase.
Maltese: Żieda fit-transaminases u fl-alkaline phosphatase tal-fwied.
English: Date of latest renewal: 17 June 2008
Maltese: Data tal-ewwel awtorizzazzjoni: 29 ta' Lulju 1998 Data tal-aħħar tiġdid: 17 ta' Ġunju 2008
English: Orlistat minimally partitions into erythrocytes.
Maltese: Orlistat jinqasam minimament f'eritroċiti.
English: • The active substance is orlistat.
Maltese: X'fih XENICAL • Is-sustanza attiva hi orlistat.
English: • Medicines for depression, psychiatric disorders or anxiousness
Maltese: • Mediċini għad-depressjoni, disturbi psikjatriċi jew ansjetà
English: The possibility of experiencing gastrointestinal adverse reactions (see section 4.8) may increase when orlistat is taken with a diet high in fat (e.g. in a 2000 kcal/day diet, > 30 % of calories from fat equates to > 67 g of fat).
Maltese: Il-possibiltà ta' esperjenza ta' reazzjonijiet avversi gastro-intestinali (ara sezzjoni 4.8) tista' tiżdied meta orlistat jittieħed flimkien ma' dieta b'kontenut għoli ta' xaħam (eż f'dieta ta' 2000 kkal/jum, > 30 % tal-kaloriji mix-xaħam ifissru > 67 g ta' xaħam).
English: The volume of distribution cannot be determined because the drug is minimally absorbed and has no defined systemic pharmacokinetics.
Maltese: Il-volum ta' distribuzzjoni ma jistax jiġi stabbilit għaliex il-mediċina tiġi assorbita minimament u m'għandha l-ebda farmakokinetika sistemika definita.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikata fuq il-portal elettroniku Ewropew tal-mediċini.
English: Allergic reactions.
Maltese: Reazzjonijiet allerġiċi.
English: Common: Anxiety
Maltese: Komuni: Ansjetà
English: Antiretrovirals for HIV: Orlistat may potentially reduce the absorption of antiretroviral medicines for HIV and could negatively affect the efficacy of antiretroviral medications for HIV (see section 4.5).
Maltese: Orlistat potenzjalment jista' jnaqqas l-assorbiment ta' mediċini antiretrovirali għall-HIV u jista' jaffettwa b'mod negattiv l-effikaċja ta' mediċini antiretrovirali għallHIV (ara sezzjoni 4.5).
English: The capsule shell consists of gelatine, indigo carmine (E132), titanium dioxide (E171) and edible printing ink.
Maltese: Il-qoxra tal-kapsula tikkonsisti f'ġelatina, indigo carmine (E132), titanium dioxide (E171) u linka li tista' tittiekel għall-istampar.
English: Hypersensitivity (e.g. pruritus, rash, urticaria, angioedema, bronchospasm and anaphylaxis)
Maltese: Sensittività eċċessiva (eż. ħakk, raxx, urtikarja,
English: Pancreatitis (inflammation of the pancreas).
Maltese: Pankreatite (infjammazzjoni tal-frixa).
English: Based on a study in obese patients, of the minimal fraction of the dose that was absorbed systemically, two major metabolites, M1 (4-member lactone ring hydrolysed) and M3 (M1 with N-formyl leucine moiety cleaved), accounted for approximately 42 % of the total plasma concentration.
Maltese: Fuq il-bażi ta' studju fuq pazjenti ħoxnin iżżejjed, mill-parti żgħira ħafna tad-doża assorbita sistematikament, żewġ metaboliti ewlenin, M1 (4-member lactone ring hydrolysed) u M3 (M1 ma' Nformyl leucine moiety cleaved), ammontaw għal madwar 42 % tal-konċentrazzjoni totali fil-plażma.
English: Overall, after one year of treatment, the percentage of patients taking 120 mg orlistat who lost 10 % or more of their body weight was 20 % with orlistat 120 mg compared to 8 % of patients taking placebo.
Maltese: Meħudin flimkien, wara sena ta' kura, il-perċentwal ta' pazjenti li kienu qed jieħdu 120 mg ta' orlistat li naqqsu 10 % jew aktar mill-piż tal-ġisem tagħhom kien 20 % b'orlistat 120 mg meta mqabbel ma' 8 % tal-pazjenti fuq il-plaċebo.
English: An additional contraceptive method is recommended in case of severe diarrhoea (see section 4.4).
Maltese: Metodu addizzjonali ta' kontraċezzjoni huwa rakkomandat f'każ ta' dijarea severa (ara sezzjoni 4.4).
English: Coagulation parameters should be monitored in patients treated with concomitant oral anticoagulants (see section 4.5 and 4.8).
Maltese: Parametri tal-koagulazzjoni għandhom jiġu sorveljati f'pazjenti kkurati fl-istess waqt b'sustanzi kontra l-koagulazzjoni tad-demm (ara sezzjoni 4.5 u 4.8).
English: Xenical 120mg hard capsules Orlistat
Maltese: Xenical 120mg kapsuli ibsin Orlistat
English: EU/1/98/071/005 42 capsules
Maltese: EU/1/98/071/005 42 kapsula
English: Decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in variations of haemostatic parameters have been reported in patients treated with anticoagulants in association with orlistat (see section 4.4 and 4.5)
Maltese: Tnaqqis fil-prothrombin, żieda fl-INR u kura mhux bilanċjata kontra l-koagulazzjoni li tirriżulta f'varjazzjonijiet tal-parametri emostatiċi kienu rrappurtati f'pazjenti kkurati b'sustanzi kontra l-koagulazzjoni f'assoċjazzjoni ma' orlistat (ara sezzjoni 4.4 u 4.5)
English: EU/1/98/071/006 84 capsules
Maltese: EU/1/98/071/006 84 kapsula
English: In view of this low inhibitory activity and the low plasma levels at therapeutic doses (average of 26 ng/ml and 108 ng/ml respectively), these metabolites are considered to be pharmacologically inconsequential.
Maltese: Minħabba din l-attività inibitorja baxxa u l livelli baxxi fil-plażma f'dożi terapewtiċi (medja ta' 26 ng/ml u 108 ng/ml rispettivament), dawn ilmetaboliti huma kkunsidrati farmakoloġikament bla ebda importanza.
English: MARKETING AUTHORISATION NUMBERS EU/1/98/071/001-006
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/98/071/001-006
English: Do not take XENICAL
Maltese: Tiħux XENICAL
English: Other medicines and Xenical
Maltese: Mediċini oħra u Xenical
English: Liquid stools
Maltese: Gass Purgar likwidu
English: Plasma concentrations of intact orlistat were non-measurable (< 5 ng/ml) eight hours following oral administration of orlistat.
Maltese: Konċentrazzjonijiet fil-plażma ta' orlistat intatt ma setgħux jiġu mkejla (< 5 ng/ml) tmien sigħat wara l-għoti orali ta' orlistat.
English: Bleeding from the back passage (rectum).
Maltese: Fsada mill-passaġġ ta' wara (rektum).
English: Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m², or overweight patients (BMI > 28 kg/m²) with associated risk factors.
Maltese: Xenical huwa indikat flimkien ma' dieta ta' kaloriji kemxejn baxxi għall-kura ta' pazjenti ħoxnin iżżejjed b'indiċi tal-massa tal-ġisem (BMI - body mass index) aktar minn, jew daqs 30 kg/m², jew għall-pazjenti b'piż żejjed (BMI > 28 kg/m²) li għandhom ukoll fatturi ta' riskju assoċjati magħhom.
English: Single doses of 800 mg orlistat and multiple doses of up to 400 mg three times daily for 15 days have been studied in normal weight and obese subjects without significant adverse findings.
Maltese: Dożi waħedhom ta' 800 mg orlistat u dożi multipli sa 400 mg tliet darbiet kuljum għal 15-il ġurnata ġew studjati f'individwi ta' piż normali u f'individwi ħoxnin iżżejjed mingħajr sejbiet avversi sinifikanti.
English: The following table of undesirable effects (first year of treatment) is based on adverse events that occurred at a frequency of > 2 % and with an incidence ≥ 1 % above placebo in clinical trials of 1 and 2 years duration:
Maltese: It-tabella li ġejja ta' effetti mhux mixtieqa (fl-ewwel sena ta' kura) hi bbażata fuq reazzjonijiet avversi li seħħew bi frekwenza ta' > 2 % u b'inċidenza ta' ≥ 1 % aktar mill-plaċebo waqt provi kliniċi li damu sena u sentejn:
English: - Hypersensitivity to the active substance or to any of the excipients.
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva.
English: Data from the 4-year clinical trial also suggested that weight loss achieved with orlistat delayed the development of type 2 diabetes during the study (cumulative diabetes cases incidences: 3.4 % in the orlistat group compared to 5.4 % in the placebo-treated group).
Maltese: Tagħrif mill-prova klinika ta' 4 snin kien jindika wkoll li t-tnaqqis tal-piż miksub b'orlistat ittardja l iżvilupp ta' dijabete tip 2 matul l-istudju (inċidenza kumulattiva ta' każijiet ta' dijabete: 3.4 % fil grupp ta' orlistat meta mqabbel ma' 5.4 % fil-grupp ikkurat bil-plaċebo).
English: Upper respiratory infection Lower respiratory infection
Maltese: Infezzjoni fl-apparat respiratorju ta' fuq Infezzjoni fl-apparat respiratorju t'isfel
English: Doses of orlistat above 120 mg three times daily have not been shown to provide additional benefit.
Maltese: Dożi ta' orlistat aktar minn 120 mg tliet darbiet kuljum ma ntweriex li jipprovdu benefiċċju addizzjonali.
English: After 4 years of treatment 21 % of the orlistat treated patients compared to 10 % of the placebo treated patients had lost ≥ 10 % of body weight, with a mean difference of 2.7 kg.
Maltese: Wara 4 snin ta' kura 21 % tal-pazjenti kkurati b'orlistat imqabbla ma' 10 % tal-pazjenti kkurati bil-plaċebo kienu naqqsu ≥ 10 % tal-piż tal ġisem, b'differenza medja ta' 2.7 kg.
English: Xenical capsules are turquoise with the imprint “XENICAL 120” and are supplied in blister packs and glass bottles, containing 21, 42 and 84 capsules.
Maltese: Il-kapsuli Xenical huma ta' lewn turkważ bil-karattri “XENICAL 120” stampati fuqhom u huma disponibbli f'pakketti bil-folji u fliexken tal-ħġieġ, li jkun fihom 21, 42 u 84 kapsula.
English: The absence of an interaction between oral contraceptives and orlistat has been demonstrated in specific drug-drug interaction studies.
Maltese: In-nuqqas ta' interazzjoni bejn kontraċettivi orali u orlistat intwera fi studji speċifiċi dwar linterazzjoni bejn mediċina u oħra.
English: Adverse reaction/event
Maltese: Reazzjoni/avveniment avvers
English: As with any weight-control program, over-consumption of fat and calories may reduce any weight loss effect.
Maltese: Bħal kull programm ieħor għall-kontroll tal-piż, konsum żejjed ta' xaħmijiet u kaloriji jista' jnaqqas kwalunkwe effett ta' tnaqqis ta' piż.
English: * only unique treatment adverse events that occurred at a frequency of > 2 % and with an incidence ≥ 1 % above placebo in obese type 2 diabetic patients.
Maltese: *Effetti avversi u uniċi tal-kura li seħħew bi frekwenza ta' > 2 % u b'inċidenza ta' ≥ 1 % aktar millplaċebo f'pazjenti ħoxnin iżżejjed b'dijabete tat-tip 2 biss.
English: In general, at therapeutic doses, detection of intact orlistat in plasma was sporadic and concentrations were extremely low (< 10 ng/ml or 0.02 µmol), with no evidence of accumulation, which is consistent with minimal absorption.
Maltese: Ġeneralment, f'dożi terapewtiċi, l-osservazzjoni ta' orlistat intatt fil-plażma kienet sporadika u l konċentrazzjonijiet kienu baxxi ferm (< 10 ng/ml jew 0.02 µmol), bl-ebda sinjal ta' akkumulazzjoni, li hija konsistenti ma' assorbiment minimu.
English: Co-administration of orlistat with ciclosporin is not recommended (see section 4.5).
Maltese: L-għoti ta' orlistat flimkien ma' ciclosporin mhux rakkomandat (ara sezzjoni 4.5).
English: However, there was an unexplained increase in the incidence of bone fractures (6 % versus 2.8 % in the orlistat and placebo groups, respectively).
Maltese: Madankollu, kien hemm żieda li ma setgħetx tiġi spjegata fl-inċidenza ta' ksur ta' għadam (6 % kontra 2.8 % fil-gruppi ta' orlistat u plaċebo, rispettivament).
English: Xenical is not recommended for people taking acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus).
Maltese: Xenical mhux rakkomandat għall-persuni li jieħdu acarbose (mediċina kontra d-dijabete użata biex tikkura dijabete mellitus tat-tip 2).
English: Each capsule contains 120 mg of orlistat.
Maltese: Kull kapsula iebsa fiha 120 mg orlistat.
English: Cholelithiasis
Maltese: Il-Ġermanja
English: • The other ingredients are microcrystalline cellulose (E460), sodium starch glycolate (type A), povidone (E1201), sodium laurilsulfate and talc.
Maltese: • Is-sustanzi l-oħra huma microcrystalline cellulose (E460), sodium starch glycolate (tip A),
English: The vast majority of patients receiving up to four full years of treatment with orlistat in clinical studies had vitamin A, D, E and K and beta-carotene levels that stayed within normal range.
Maltese: Fi studji kliniċi l-biċċa l-kbira tal-pazjenti li rċevew sa erba' snin sħaħ ta' kura b'orlistat kellhom livelli ta' vitamini A, D, E u K u ta' beta-carotene li baqgħu fil-firxa normali.
English: Do not take a double dose.
Maltese: Tiħux doża doppja.
English: Rectal pain/discomfort Soft stools
Maltese: Uġigħ/skonfort addominali
English: Upon discontinuation of therapy, faecal fat content usually returns to pre-treatment levels, within 48 to 72 hours.
Maltese: Kif titwaqqaf it-terapija, il-kontenut ta' xaħam fl-ippurgar normalment jerġa' lura għal-livelli ta' qabel il-kura fi żmien 48 sa 72 siegħa.
English: In a 4 year clinical trial, the general pattern of adverse event distribution was similar to that reported for the 1 and 2 year studies with the total incidence of gastrointestinal related adverse events occurring in year 1 decreasing year on year over the four year period.
Maltese: Fi prova klinika ta' 4 snin, ix-xejra ġenerali f'dak li hu tqassim ta' effetti avversi kienet simili għal dik irrappurtata għall-istudji ta' sena waħda u sentejn bl-inċidenza totali ta' effetti avversi relatati malapparat gastro-intestinali li seħħew fl-ewwel sena jonqsu minn sena għal oħra fil-perjodu ta' erba'
English: Data from the 4-year XENDOS clinical trial showed that 60 % of orlistat patients and 35 % of placebo patients demonstrated a loss of at least 5 % of their baseline body weight after 12 weeks of treatment.
Maltese: Tagħrif mill-prova klinika ta' 4 snin XENDOS wera li 60 % tal-pazjenti fuq orlistat u 35 % tal pazjenti fuq plaċebo wrew tnaqqis ta' mill-inqas 5 % tal-piż tal-ġisem tagħhom fil-linja bażi wara 12-il ġimgħa ta' kura.
English: In patients receiving concomitant amiodarone treatment, reinforcement of clinical and ECG monitoring is warranted.
Maltese: F'pazjenti li jirċievu kura b'amiodarone fl-istess waqt, ir-rinforz ta' monitoraġġ kliniku u ta' ECG huwa ġġustifikat.
English: C.
Maltese: A.
English: In obese type 2 diabetic patients insufficiently controlled by antidiabetic agents, data from four oneyear clinical trials showed that the percentage of responders (≥ 10 % of body weight loss) was 11.3 % with orlistat as compared to 4.5 % with placebo.
Maltese: F'pazjenti ħoxnin iżżejjed u b'dijabete tip 2 mhux ikkontrollati biżżejjed b'sustanzi antidijabetiċi, tagħrif minn erba' provi kliniċi ta' sena wera li l-perċentwal ta' dawk li jirrispondu għall-kura (tnaqqis ta' ≥ 10 % tal-piż tal-ġisem) kien ta' 11.3 % b'orlistat meta mqabbel ma' 4.5 % bil-plaċebo.
English: A decrease in ciclosporin plasma levels has been observed in a drug-drug-interaction study and also reported in several cases, when orlistat was administered concomitantly.
Maltese: Ciclosporin Kien osservat tnaqqis fil-livelli ta' ciclosporin fil-plażma fi studju dwar l-interazzjoni bejn mediċina u oħra u kien ukoll rappurtat f'diversi każijiet meta orlistat ingħata fl-istess waqt.
English: When warfarin or other anticoagulants are given in combination with orlistat, international normalised ratio (INR) values should be monitored (see section 4.4).
Maltese: Sustanzi kontra l-koagulazzjoni li jittieħdu mill-ħalq Meta warfarin jew xi sustanzi oħra kontra l-koagulazzjoni jingħataw flimkien ma' orlistat, il-valuri ta' proporzjon normalizzat internazzjonali (INR - international normalised ratio) għandhom jiġu monitorjati (ara sezzjoni 4.4).
English: Studies in normal weight and obese volunteers have shown that the extent of absorption of orlistat was minimal.
Maltese: Assorbiment Studji fuq voluntiera ta' piż normali u oħrajn ħoxnin iżżejjed urew li l-assorbiment ta' orlistat kien minimu.
English: Xenical has been studied in long-term clinical studies of up to 4 years duration.
Maltese: Xenical ġie studjat fi studji kliniċi fuq tul ta' żmien li damu sa 4 snin.
English: M1 and M3 have an open beta-lactone ring and extremely weak lipase inhibitory activity (1000 and 2500 fold less than orlistat respectively).
Maltese: (1000 u 2500 darba inqas minn orlistat rispettivament).
English: Adverse events are listed below by system organ class and frequency.
Maltese: Avvenimenti avversi huma mniżżla taħt skont il-klassi tas-sistemi u tal-organi u l-frekwenza.
English: - Cholestasis.
Maltese: - Kolestasi
English: Of these, 62 % of orlistat treated patients and 52 % of placebo treated patients went on to lose ≥ 10 % of their baseline body weight at one year.
Maltese: Minn dawn, 62 % tal-pazjenti kkurati b'orlistat u 52 % tal-pazjenti kkurati bil plaċebo komplew biex naqqsu ≥ 10 % tal-piż tal-ġisem tagħhom fil-linja bażi wara sena.
English: The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea.
Maltese: L-użu ta' metodu addizzjonali ta' kontraċezzjoni huwa rakkomandat biex jipprevjeni l-falliment possibbli ta' mediċini kontraċettivi orali li jista' jiġri f'każ ta' dijarea severa.
English: Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs e.g. valproate, lamotrigine, for which a causal relationship to an interaction cannot be excluded.
Maltese: Kienu rrappurtati konvulżjonijiet f'pazjenti kkurati b'orlistat flimkien ma' mediċini kontra l-epilessija eż. valproate, lamotrigine, li għalihom, relazzjoni kawżali għall-interazzjoni ma tistax tiġi eskluża.
English: Hepatitis (inflammation of the liver).
Maltese: Epatite (infjammazzjoni tal-fwied).
English: Common side effects (affects 1 to 10 users in 100)
Maltese: Effetti sekondarji komuni (jaffettwaw minn persuna waħda sa 10 minn kull 100 li qed jużawh)