FrancophonIA/ELRC3.0 huggingface dataset:
English: There are some case reports of reduced efficacy of antiretroviral HIV medicines, antidepressants antipsychotics (including lithium) and benzodiazepines coincidental to the initiation of orlistat treatment in previously well-controlled patients.
Maltese: antidepressanti, antipsikotiċi (inkluż lithium) u benzodiazepines li seħħew meta nbdiet kura b'orlistat f'pazjenti li qabel kienu kkontrollati tajjeb.
English: NAME OF THE MEDICINAL PRODUCT Xenical 120 mg hard capsules
Maltese: Xenical 120 mg kapsuli iebsa
English: The disposition of orlistat appeared to be similar between normal weight and obese volunteers.
Maltese: Iddispożizzjoni ta' orlistat dehret li kienet simili bejn voluntiera b'piż normali u dawk ħoxnin iżżejjed.
English: NAME OF THE MEDICINAL PRODUCT Xenical 120 mg hard capsules Orlistat
Maltese: Xenical 120 mg kapsuli ibsin Orlistat
English: NAME OF THE MARKETING AUTHORISATION HOLDER CHEPLAPHARM Arzneimittel GmbH
Maltese: PREKAWZJONIJIET SPEĊJALI GĦAR-RIMI TA' PRODOTTI MEDIĊINALI MHUX
English: Both populations received multivitamin supplements.
Maltese: milli f'pazjenti li mhumiex dijabetiċi.
English: Common: Fatigue
Maltese: Komuni: Għeja
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u rriskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: The cumulative renal excretion of total orlistat-related materials was < 2 % of the given dose.
Maltese: It-tneħħija kumulattiva mill-kliewi tal-materjal kollu relatat ma' orlistat kienet ta' < 2 % tad-doża mogħtija.
English: Very common: Headache Respiratory, thoracic and mediastinal disorders Very common:
Maltese: Komuni ħafna: Uġigħ ta' ras Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna:
English: The mechanism, although not proven, may involve a decreased absorption of iodine salts and/or levothyroxine (see section 4.5).
Maltese: Il mekkaniżmu, għalkemm mhux ipprovat, jista' jinvolvi assorbiment imnaqqas ta' mluħa ta' iodine u/jew ta' levothyroxine (ara sezzjoni 4.5).
English: Lack of interactions
Maltese: Nuqqas ta' interazzjonijiet
English: As it is not known whether orlistat is secreted into human milk, orlistat is contra-indicated during breast-feeding.
Maltese: Peress li mhuwiex magħruf jekk orlistat jgħaddix fil-ħalib tas-sider uman, orlistat huwa kontraindikat waqt it-treddigħ.
English: Rare occurrence of hypothyroidism and/or reduced control of hypothyroidism may occur.
Maltese: il-possibiltà ta' effetti gastro-intestinali tista' tiżdied.
English: The time to reach complete excretion (faecal plus urinary) was 3 to 5 days.
Maltese: Iż-żmien biex tintlaħaq tneħħija totali (purgar u awrina) kien ta' 3 sa 5 ijiem.
English: Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (A, D, E and K).
Maltese: Kura b'orlistat għandu mnejn iddgħajjef l-assorbiment ta' vitamini li jinħallu fix-xaħam (A, D, E u K).
English: Rectal pain/discomfort, soft stools, incontinence (stools), bloating (experienced by some people with type 2 diabetes), tooth/gum disorder, irregularity of menstrual cycle, tiredness.
Maltese: Uġigħ/skonfort fir-rektum, purgar artab, purgar mhux ikkontrollat, nefħa addominali (esperjenzati minn xi persuni b'dijabete tip 2), disturb fis-snien/ħanek, irregolarità fiċ-ċiklu mestrwali, għeja.
English: Store in original package and keep the blister in the outer carton in order to protect from light and moisture.
Maltese: Lammont ta' xaħmijiet, karboidrati u proteini kkunsmati kuljum għandu jitqassam fuq tliet ikliet prinċipali.
English: The side effects were generally similar to those observed in adults.
Maltese: L-effetti sekondarji ġeneralment kienu bħal dawk osservati f'adulti.
English: The difference was driven by the outcome in the group of patients with ≥ 5 % weight loss after 12 weeks of treatment with orlistat representing 19 % of the initial population.
Maltese: Id-differenza kienet aċċentwata bir-riżultat tal-grupp ta' pazjenti bi tnaqqis ta' ≥ 5 % tal-piż wara 12-il ġimgħa ta' kura b'orlistat li jirrappreżenta 19 % tal-popolazzjoni tal-bidu.
English: Of these, 49 % of orlistat treated patients and 40 % of placebo treated patients went on to lose ≥ 10 % of their baseline body weight at one year.
Maltese: Minn dawn, 49 % tal-pazjenti kkurati b'orlistat u 40 % tal-pazjenti kkurati bil-plaċebo komplew biex naqqsu ≥ 10 % tal-piż tal-ġisem tagħhom fil-linja bażi wara sena waħda.
English: Abdominal pain/discomfort Oily spotting from the rectum Flatus with discharge Faecal urgency Fatty/oily stool Flatulence
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali mniżżla f'Appendiċi V*.
English: Adverse reactions to orlistat are largely gastrointestinal in nature.
Maltese: Reazzjonijiet avversi għal orlistat fil-biċċa l-kbira huma ta' natura gastro-intestinali.
English: Headache, abdominal pain/discomfort, urgent or increased need to open the bowels, flatulence (wind) with discharge, oily discharge, oily or fatty stools, liquid stools, low blood sugar levels (experienced by some people with type 2 diabetes).
Maltese: Uġigħ ta' ras, uġigħ/skonfort addominali, bżonn urġenti jew akbar biex tipporga, gass bil-ħruġ ta' purgar, ħruġ ta' likwidu żejtni, purgar żejtni jew xaħmi, purgar likwidu, livelli baxxi ta' zokkor fid demm (esperjenzati minn xi persuni b'dijabete tip 2).
English: Blisters: Do not store above 25 °C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25 °C.
English: Glass bottles with desiccant containing 21, 42 and 84 hard capsules.
Maltese: Fliexken tal-ħġieġ b'desikkant li fihom 21, 42 u 84 kapsula iebsa.
English: The results were significantly superior in the orlistat group (difference in BMI of 0.86 kg/m2 in favour of orlistat).
Maltese: Ir-riżultati kienu sostanzjalment aħjar fil-grupp ta' orlistat (differenza fil-BMI ta' 0.86 kg/m2 favur orlistat). 9.5 % tal-pazjenti kkurati b'orlistat kontra 3.3 % tal-pazjenti li ħadu plaċebo naqqsu ≥ 10 %
English: 84 hard capsules
Maltese: 21 kapsula iebsa 42 kapsula iebsa 84 kapsula iebsa
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Your doctor may suggest you take a multivitamin supplement.
Maltese: Iż-żewġ popolazzjonijiet irċevew supplimenti ta' multivitamini.
English: After 1 year of treatment, 41 % of the orlistat treated patients versus 21 % of placebo treated patients lost ≥ 10 % of body weight with a mean difference of 4.4 kg between the two groups.
Maltese: kura, 41 % tal-pazjenti kkurati b'orlistat kontra 21 % tal-pazjenti kkurati bil-plaċebo naqqsu ≥ 10 %
English: The mean difference in weight loss with the drug compared to placebo was 3.2 kg.
Maltese: piż bil-mediċina meta mqabbel mal-plaċebo kienet ta' 3.2 kg.
English: The great majority of diabetes cases came from the subgroup of patients with impaired glucose tolerance at baseline, which represented 21 % of the randomised patients.
Maltese: Il-parti l-kbira tal-każijiet ta' dijabete ġew mis-sottogrupp ta' pazjenti b'tolleranza mnaqqsa ta' glukosju fil-linja bażi, li rrappreżentaw 21 % tal-pazjenti randomised.
English: Pooled data from five 2 year studies with orlistat and a hypocaloric diet showed that 37 % of orlistat patients and 19 % of placebo patients demonstrated a loss of at least 5 % of their baseline body weight after 12 weeks of treatment.
Maltese: 37 % tal-pazjenti fuq orlistat u 19 % 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: A slight decrease in plasma levels of amiodarone, when given as a single dose, has been observed in a limited number of healthy volunteers who received orlistat concomitantly.
Maltese: F'numru limitat ta' voluntiera f'saħħithom li ħadu orlistat fl-istess waqt, kien osservat tnaqqis ħafif fillivelli tal-plażma ta' amiodarone, meta ngħata bħala doża waħda.
English: Faecal incontinence Abdominal distension* Tooth disorder Gingival disorder
Maltese: • jekk inti allerġiku (tbati minn sensittività eċċessiva) għal orlistat jew għal xi sustanza oħra ta'
English: The mechanism, although not proven, may involve a decreased absorption of iodine salts and/or levothyroxine (see section 4.4).
Maltese: Ilmekkaniżmu, għalkemm mhux ipprovat, jista' jinvolvi assorbiment imnaqqas ta' mluħa ta' iodine u/jew ta' levothyroxine (ara sezzjoni 4.4).
English: Xenical is indicated in the treatment of obesity in conjunction with a low calorie intake diet.
Maltese: Xenical huwa indikat fil-kura ta' ħxuna żejda flimkien ma' dieta ta' kaloriji baxxi.
English: The possibility of this happening may increase if Xenical is taken with a diet high in fat.
Maltese: Kienu rrappurtati xi każijiet fatali jew każijiet li jeħtieġu trapjant tal-fwied.
English: In patients receiving amiodarone treatment, the clinical relevance of this effect remains unknown but may become clinically relevant in some cases.
Maltese: F'pazjenti li jkunu qed jirċievu kura b'amiodarone, ir-rilevanza klinika ta' dan l-effett għad mhix magħrufa iżda f'xi każijiet tista' ssir klinikament rilevanti.
English: Conversely, of patients failing to demonstrate a loss of 5 % of their baseline body weight after 12 weeks of treatment, only 5 % of orlistat treated patients and 4 % of placebo treated patients went on to lose ≥ 10 % of their baseline body weight at one year.
Maltese: Għall kuntrarju, mill-pazjenti li ma rnexxilhomx juru tnaqqis ta' 5 % tal-piż tal-ġisem tagħhom fil-linja bażi wara 12-il ġimgħa ta' kura, 5 % biss tal-pazjenti kkurati b'orlistat u 4 % biss tal-pazjenti kkurati bil plaċebo spiċċaw biex naqqsu ≥ 10 % tal-piż tal-ġisem tagħhom fil-linja bażi wara sena.
English: The effect of orlistat results in an increase in faecal fat as early as 24 to 48 hours after dosing.
Maltese: L-effett ta' orlistat jirriżulta f'żieda ta' xaħam fl-ippurgar sa minn 24 sa 48 siegħa wara li tittieħed iddoża.
English: The primary endpoint was the change in body mass index (BMI) from baseline to the end of the study.
Maltese: Il-punt finali primarju kien il-bidla fl-indiċi tal-massa tal-ġisem (BMI - body mass index) mil-linja bażi sa l-aħħar tal-istudju.
English: What XENICAL looks like and contents of the pack
Maltese: Kif jidher XENICAL u l-kontenut tal-pakkett
English: 8 August 2012
Maltese: 8 ta' Awwissu 2012
English: What is Flolan?
Maltese: X'inhu Flolan?
English: Flolan is marketed in the following EU Member States: Austria, Belgium, Czech Republic, Denmark, Estonia, France, Ireland, Italy, Luxembourg, Malta, the Netherlands, Spain, United Kingdom, as well as Norway.
Maltese: Flolan jitqiegħed fis-suq fl-Istati Membri tal-UE li ġejjin: l-Awstrija, il-Belġju, ir-Repubblika Ċeka, idDanimarka, l-Estonja, Franza, l-Irlanda, l-Italja, il-Lussemburgu, Malta, il-Pajjiżi l-Baxxi, Spanja, irRenju Unit, kif ukoll in-Norveġja.
English: Flolan is a medicine that contains the active substance epoprostenol.
Maltese: Flolan huwa mediċina li fiha s-sustanza attiva l-epoprostenol.
English: • treatment of pulmonary arterial hypertension (PAH) (idiopathic or heritable PAH and PAH
Maltese: • kura ta' pressjoni arterjali pulmonari għolja (PAH) (PAH idjopatika jew ereditarja u PAH
English: The CHMP also harmonised other sections of the SmPC including sections 4.6 (pregnancy and lactation), 4.5 (Interaction with Other Medicinal Products and Other Forms of Interaction) and 4.8 (side effects).
Maltese: Is-CHMP armonizza wkoll sezzjonijiet oħra tal-SmPC inkluż sezzjonijiet 4.6 (Tqala u treddigħ), 4.5 (Interazzjoni ma' Prodotti Mediċinali Oħra u Forom Oħra ta' Interazzjoni) u 4.8 (Effetti mhux mixtieqa).
English: On 24 May 2012, the European Medicines Agency completed a review of Flolan.
Maltese: Fl-24 ta' Mejju 2012, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni ta' Flolan.
English: associated with connective tissue diseases) in patients with WHO functional class III-IV
Maltese: assoċjata ma' mard tat-tessut konnettiv) f'pazjenti b'sintomi tal-klassi funzjonali III-IV tad
English: Flolan was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Flolan ġie identifikat li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni dwar il-Proċeduri Reċiproċi u Deċentralizzati - Umani (CMD(h)).
English: Flolan is authorised in the EU via national procedures.
Maltese: Flolan huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: In harmonising the contraindications, the CHMP decided to remove three contraindications that were in the SmPCs of some EU countries: pulmonary veno-occlusive disease, hypotension and angina.
Maltese: Fl-armonizzazzjoni tal-kontra-indikazzjonijiet, is-CHMP iddeċieda li jneħħi tliet kontra-indikazzjonijiet li kienu fl-SmPCs ta' xi pajjiżi tal-UE: mard pulmonari veno-okklussiv, pressjoni baxxa u anġina.
English: Flolan is also used to treat a lung condition called ‘pulmonary arterial hypertension' (high blood pressure in the lungs).
Maltese: Flolan jintuża wkoll fil-kura ta' kundizzjoni tal-pulmun magħrufa bħala ‘pressjoni arterjali pulmonari għolja' (pressjoni għolja tad-demm fil-pulmuni).
English: On 15 June 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Flolan in the EU.
Maltese: Fil-15 ta' Ġunju 2011, il-Kummissjoni Ewropea rriferiet il-kwistjoni lis-CHMP biex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Flolan fl-UE.
English: Why was Flolan reviewed?
Maltese: Għaliex ġie rivedut Flolan?
English: Having harmonised the indications, the CHMP also harmonised the recommendations on the use of Flolan in the elderly and patients with reduced kidney and liver function.
Maltese: Wara li armonizza l-indikazzjonijiet, is-CHMP armonizza wkoll ir-rakkomandazzjonijiet dwar l-użu ta' Flolan fl-anzjani u fuq pazjenti b'funzjoni indebolita tal-kliewi u tal-fwied.
English: The CHMP was of the view that patients with pulmonary veno-occlusive disease could benefit from treatment with Flolan and that for hypotension and angina it was more appropriate to include relevant warnings in section 4.4.
Maltese: Is-CHMP kien tal-fehma li pazjenti b'mard pulmonari veno-okklussiv jistgħu jibbenefikaw minn kura bi Flolan u li għall-pressjoni baxxa u għall-anġina kien aktar xieraq li twissijiet rilevanti jiġu nklużi fis-sezzjoni 4.4.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Flolan in the European Union (EU).
Maltese: Il-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li jeħtieġ li l-informazzjoni tal-preskrizzjoni għal Flolan tiġi armonizzata fl-Unjoni Ewropea (UE).
English: The active substance in Flolan, epoprostenol, is a natural occurring prostaglandin that works by stopping the blood from clotting.
Maltese: Is-sustanza attiva fi Flolan, l-epoprostenol, hija prostaglandin li sseħħ b'mod naturali li taħdem billi twaqqaf id-demm milli jagħqad.
English: • haemodialysis in emergency situations when the use of heparin carries a high risk of causing or exacerbating bleeding, or when heparin is otherwise contraindicated.
Maltese: • emodijaliżi f'sitwazzjonijiet ta' emerġenza fejn l-użu tal-eparina jġorr riskju għoli li jikkawża jew jaggrava l-fsada, jew inkella fejn l-eparina hija kontraindikata.
English: It is also available under the trade name Epoprostenol.
Maltese: Jiġi wkoll taħt l-isem kummerċjali Epoprostenol.
English: - The active substance is imiglucerase.
Maltese: - Is-sustanza attiva hi imiglucerase.
English: • thrombocytopenia
Maltese: • tromboċitopenija
English: MedDRA System Organ Class
Maltese: Sistema tal-Klassifka tal-Organi
English: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Maltese: Genzyme Ltd, 37 Hollands Road, Haverhill, Suffolk, CB9 8PU, Renju Unit Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, L-Irlanda
English: Date of first authorisation: 17 November 1997 Date of latest renewal: 17 September 2007
Maltese: Data tal-ewwel awtorizzazzjoni: 17 ta' Novembru 1997 Data tal-aħħar tiġdid:17/09/2007
English: STATEMENT OF ACTIVE SUBSTANCE
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA
English: Plasma clearance ranged from 9.8 to 20.3 ml/min/kg, (mean ± S.D, 14.5 ± 4.0 ml/min/kg).
Maltese: Ir-rata tat-tneħħija mill-plażma kienet ta' bejn 9.8 sa 20.3 ml/min/kg, (medja ± S.D, 14.5 ± 4.0 ml/min/kg).
English: Adverse reactions are listed by system organ class and frequency (common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000)) in the table below.
Maltese: (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa 1/100) u rari (≥1/10,000 sa <1/1,000)) fil-lista hawn taħt.
English: Clinically, Gaucher disease is a heterogeneous phenotypic spectrum.
Maltese: Klinikament, il-marda ta' Gaucher hi spectrum fenotipiku eteroġenu.
English: Gaucher disease is a rare recessively inherited metabolic disorder that results from a deficiency of the lysosomal enzyme acid β-glucosidase.
Maltese: Il-marda ta' Gaucher hi marda ereditarja rari riċessiva li tiriżultata minn defiċjenza ta' lysosomal enzyme acid β-glucosidase.
English: Imiglucerase is a modified form of the human enzyme acid β-glucosidase produced by recombinant DNA technology.
Maltese: Imiglucerase hi forma modifikata ta' enżima umana acid β-glucosidase prodott mit-teknoloġija rikombinanti tad-DNA.
English: Contents of the pack and other information.
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Pack sizes: 1, 5 or 25 vials per carton.
Maltese: Kunjett 1, 5 jew 25 kunjett kull kartuna.
English: Cerezyme is a white to off-white powder.
Maltese: Cerezyme hu trab ta' kulur bejn bajdani u off-white.
English: The natural history of Gaucher disease usually shows progression, with the risk of irreversible complications arising in various organs over time.
Maltese: L-istorja medika naturali tal-marda ta' Gaucher normalment turi progressjoni, bir-riskju ta' kumplikazzjonijiet irriversibbli li jseħħu f'diversi organi maż-żmien.
English: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP, Amsterdam, the Netherlands
Maltese: Genzyme Europe B.V, Paasheuvelweg 25, 1105 BP Amsterdam, l-Olanda
English: The ICGG Gaucher Registry
Maltese: Ir-Reġistru ta' l-ICGG Gaucher
English: Then dilute the combined volumes with 0.9% sodium chloride intravenous solution to a total volume of 100 to 200 ml.
Maltese: Imbagħad iddilwa l-volumi mħallta b' soluzzjoni ta' 0.9% ta' sodium chloride li tingħata ġol-vina għal volum totali ta' 100 sa 200 ml.
English: Patients with antibody to imiglucerase have a higher risk of hypersensitivity reactions (see section 4.8).
Maltese: Pazjenti b'anti-korpi għal imiglucerase għandhom riskju ogħla ta' reazzjonijiet ta' sensittività eċċessiva (ara sezzjoni 4.8).
English: • hepatomegaly or splenomegaly
Maltese: • epatomegalija jew splenomegalija
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu skeletriċi u tat-tessut konnettiv
English: Excipients: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: Following infusion, plasma enzymatic activity declined rapidly with a half-life ranging from 3.6 to 10.4 minutes.
Maltese: Wara l-infużjoni, l-attività enzimatika tal-plażma naqset malajr b'half-life ta' bejn 3.6 sa 10.4 minuti.
English: Excipients: mannitol, sodium citrate, citric acid monohydrate and polysorbate 80.
Maltese: Eċċipjenti: mannitol, sodium citrate, citric acid monohydrate u polysorbate 80.
English: Cerezyme contains sodium
Maltese: Cerezyme fih is-sodium
English: Sixty-three percent of Q4- and 81% of Q2treated patients met the composite endpoint at Month 24; the difference was not statistically significant based on the 95% CI (-0.357, 0.058).
Maltese: Tlieta u sittin fil-mija tal-pazjenti kkurati fi Q4, u 81% ta' dawk ikkurati fi Q2, issodisfaw l-endpoint kompost f'Xahar 24; id-differenza ma kinitx statistikament sinifikanti bbażat fuq il-95% CI (-0.357, 0.058).
English: Name and address of the manufacturer of the biological active substance Genzyme Corporation, 500 Soldiers Field Road, Allston, MA 02134, USA Lonza Biologics Inc., 101 International Drive, Portsmouth, NH 03801-2815, USA Name and address of the manufacturers responsible for batch release Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Maltese: Soldiers Field Road, Allston, MA 02134, USA Lonza Biologics Inc., 101 International Drive, Portsmouth, NH 03801-2815, USA Isem u indirizz tal-manifatturi responsabbli mill-ħruġ tal-lott.
English: Limited experience from 150 pregnancy outcomes (primarily based on spontaneous reporting and literature review) is available suggesting that use of Cerezyme is beneficial to control the underlying Gaucher disease in pregnancy.
Maltese: Esperjenza limitata minn 150 każ ta' tqala (ibbażati prinċipalment minn rapporti spontanji u reviżjoni tal-letteratura medika) hi disponibbli li tissuġerixxi li l-użu ta' Cerezyme hu ta' siwi biex jikkontrolla l-marda ta' Gaucher fl-isfond fit-tqala.
English: Other medicines and Cerezyme
Maltese: Mediċini oħra u Cerezyme
English: 1105 BP Amsterdam The Netherlands
Maltese: BP Amsterdam, l-Olanda.
English: Pharmacotherapeutic group: Enzymes-Imiglucerase (recombinant macrophage targeted βglucocerebrosidase), ATC code: A16AB02.
Maltese: Enżimi-Imiglucerase (β-glukocerebrosidase rikombinanta u mmirata lejn il-makrofagi), Kodiċi ATC:
English: Use Aseptic Technique
Maltese: Użu ta' Teknika Asettika
English: The usual frequency of infusion is once every 2 weeks (see section 4.2).
Maltese: Il-frekwenza tas-soltu tal-infużjoni hi darba kull ġimagħtejn (ara sezzjoni 4.2).
English: In addition, Gaucher disease has been associated with an increased risk of immunoglobulin abnormalities such as hyperimmunoglobulinemia, polyclonal gammopathy, monoclonal gammopathy of undetermined significance (MGUS) and multiple myeloma.
Maltese: Flimkien ma' dan, il-marda ta' Gaucher kienet assoċjata ma' żieda fir-riskju ta' anormalitajiet fl-immunoglobulina bħal iperimmunoglobulinemija, gammopatija poliklonali, gammopatija monoklonali ta' sinifikat mhux stabbilit (MGUS) u majeloma multipla.
English: After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase per ml (200 U/5 ml).
Maltese: Wara r-rikonstituzzjoni, is-soluzzjoni fiha 40 unità (madwar 1.0 mg) ta' imiglucerase kull ml, (200 U/5 ml).
English: A Q4 infusion regimen may be a therapeutic option for some adult patients with stable residual Gaucher disease type 1, but clinical data are limited.
Maltese: Kors ta' infużjoni fi Q4 jista' jkun għażla terapewtika għal xi pazjenti adulti b'marda stabbli ta' Gaucher residwa ta' tip 1, iżda dejta klinika hi limitata.
English: Vomiting, nausea, abdominal cramping, diarrhoea
Maltese: Remettar, dardir, brim addominali, dijarea
English: Cerezyme should not be given as a mixture with other medicinal products in the same infusion (drip).
Maltese: Cerezyme m'għandux jingħata bħala taħlita ma' prodotti mediċinali oħra fl-istess infużjoni (dripp).
English: - The other ingredients are: mannitol, sodium citrate, citric acid monohydrate and polysorbate 80.
Maltese: TA' EĊĊIPJENTI Eċċipjenti: mannitol, sodium citrate, citric acid monohydrate u polysorbate 80.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu/,.