FrancophonIA/ELRC3.0 huggingface dataset:
English: • the CVMP considered that, taking into account the high variation observed, a single harmonised withdrawal period based on all available residue intake data should be established for all products concerned that contain ivermectin as the only active substance;
Maltese: • is-CVMP kkunsidra, meta wieħed iqis il-varjazzjoni kbira osservata, għandu jiġi stabbilit perjodu ta' rtirar uniku armonizzat ibbażat fuq id-dejta kollha disponibbli dwar it-teħid ta' residwi għall-prodotti kollha kkonċernati li fihom ivermectin bħala l-unika sustanza attiva;
English: 2.1 Calculation of a harmonised withdrawal period for ivermectin containing injectable products for use in cattle
Maltese: 2.1 Kalkolu ta' perjodu ta' rtirar armonizzat għall-prodotti injettabbli li fihom ivermectin għallużu fl-ifrat
English: IVERTIN Ivermectin 10 mg/ml
Maltese: Evomec Ivermectin 10 mg/ml
English: Recommended administration dose
Maltese: Doża rakkomandata
English: It was noted that some of the studies were identical but were submitted by different MAHs.
Maltese: Ġie nnutat li xi wħud mill-istudji kienu identiċi iżda ġew sottomessi minn MAHs differenti.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF INJECTABLE VETERINARY MEDICINAL PRODUCTS CONTAINING IVERMECTIN
Maltese: (2004) Pharmacokinetic evaluation of four ivermectin generic formulations in calves.
English: S.C. ROMVAC COMPANY S.A. Şos.
Maltese: Ir-Rumanija FARMAVET S.A. Str.
English: FROMMECTIN Ivermectin 10 mg/ml
Maltese: Intermectin Ivermectin 10 mg/ml
English: CEVA SANTE ANIMALE Str. Chindiei, nr. 5
Maltese: Ir-Rumanija CEVA SANTE ANIMALE Str.
English: Ivomec F
Maltese: Xaħam Fwied
English: Virbamec Inektionslösung
Maltese: Virbamec Inektionslösu ng
English: In the figure below, all available data for the total intake of ivermectin residues is plotted and compared to the ADI.
Maltese: Fil-figura ta' hawn taħt, id-dejta kollha disponibbli għad-doża totali ta' residwi ta' ivermectin hija ppreżentata fi grafiku u mqabbla mal-ADI.
English: Subcutaneous Cattle, Sheep, Reindeer: 200 μg ivermectin/kg bw
Maltese: Subkutanju Frat, Ċriev: 200 μg ivermectin/kg bw
English: Sumex Injektion für Rinder
Maltese: Injektion für Rinder
English: Alstomec
Maltese: Pesthera
English: United Kingdom ECO Animal Health Ltd 78 Coombe Road
Maltese: Il-Ġermanja ECO Animal Health Ltd 78 Coombe Road
English: Norway
Maltese: Bielawa
English: • the CVMP assessed the original data provided during this referral and concluded that, based on these data, an impact of formulation on residue depletion could not be demonstrated and that the variability in the data was such that an effect of formulation on residue depletion could have been masked;
Maltese: • is-CVMP evalwa d-dejta oriġinali pprovduta matul din ir-referenza u kkonkluda li, fuq il-bażi ta' din id-dejta, ma setax jintwera l-impatt tal-formulazzjoni fuq it-tnaqqis tar-residwi u li lvarjabilità fid-dejta kienet tali li effett ta' formulazzjoni fuq it-tnaqqis tar-residwi seta' ġie moħbi;
English: Based on these MRLs, the daily intake of total residues will represent about 15% of the ADI.
Maltese: Ibbażata fuq dawn il-MRLs, id-doża ta' kuljum tar-residwi totali tikkorrispondi għal madwar 15% talADI.
English: Jylamvo (methotrexate)
Maltese: Jylamvo (metotreksat)
English: Further information on Jylamvo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/jylamvo.
Maltese: Aktar informazzjoni dwar Jylamvo tinstab fis-sit web tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/jylamvo.
English: Jylamvo received a marketing authorisation valid throughout the EU on 29 March 2017.
Maltese: Jylamvo rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fid-29 ta' Marzu 2017.
English: Jylamvo is a ‘hybrid medicine'.
Maltese: Jylamvo huwa “mediċina ibrida”.
English: Jylamvo is an anti-inflammatory and cancer medicine used to treat the following conditions:
Maltese: Jylamvo huwa mediċina anti-infjammatorja u mediċina kontra l-kanċer użata fil-kura ta' dawn ilkundizzjonijiet li ġejjin:
English: Jylamvo contains the active substance methotrexate.
Maltese: Jylamvo fih is-sustanza attiva metotreksat.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Jylamvo is given in a different way.
Maltese: Dan ifisser li huwa simili għal "mediċina ta' referenza" li fiha l-istess sustanza attiva, iżda Jylamvo jingħata b'mod differenti.
English: The company provided data from the published literature on the benefits and risks of methotrexate in the approved uses.
Maltese: Il-kumpanija pprovdiet data mil-letteratura ppubblikata dwar il-benefiċċji u r-riskji ta' metotreksat flużijiet approvati.
English: • active rheumatoid arthritis (a disease causing inflammation in joints) in adults;
Maltese: • artrite rewmatojde attiva (marda li tikkawża infjammazzjoni fil-ġogi) fl-adulti;
English: What are the risks associated with Jylamvo?
Maltese: X'inhuma r-riskji assoċjati ma' Jylamvo?
English: Other information about Jylamvo
Maltese: Informazzjoni oħra dwar Jylamvo
English: Jylamo must not be used in patients who abuse alcohol or those with liver or severe kidney problems, blood disorders, weakened immune system (body defences), severe or long-term infections such as tuberculosis and HIV infection, mouth ulcers, inflammation in the mouth, and ulcers in the digestive system.
Maltese: Jylamvo m'għandux jintuża f'pazjenti li jabbużaw mill-alkoħol jew dawk bi problemi fil-fwied jew problemi serveri fil-kliewi, disturbi tad-demm, sistemi immunitarji mdgħajfa (difiżi tal-ġisem), infezzjonijiet severi jew fit-tul bħat-tuberkulożi u l-infezzjoni tal-HIV, ulċeri fil-ħalq, infjammazzjoni filħalq, u ulċeri fis-sistema diġestiva.
English: The most serious side effects include reduced production of blood cells, damage to the lung, liver, kidneys and nerves, thromboembolism (problems caused by clots in blood vessels), and severe allergic and skin reactions.
Maltese: L-effetti sekondarji laktar serji jinkludu produzzjoni mnaqqsa ta' ċelloli tad-demm, ħsara lill-pulmun, il-fwied, il-kliewi u nnervituri, tromboemboliżmu (problemi kkawżati minn emboli fil-vażi tad-demm), u reazzjonijiet allerġiċi u tal-ġilda severi.
English: • severe psoriatic arthritis (inflammation of joints that occurs in patients with psoriasis) in adults;
Maltese: • artrite psorjatika severa (infjammazzjoni tal-ġogi li sseħħ fil-pazjenti bi psorjasi) fl-adulti;
English: The European Medicines Agency decided that Jylamvo was of comparable quality and was bioequivalent to the methotrexate-containing medicines Methotrexat Lederle and Ebetrexat.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li Jylamvo kien ta' kwalità komparabbli u kien bijoekwivalenti għall-mediċini Methotrexat Lederle u Ebetrexat li fihom il-metotressat.
English: The reference medicine for Jylamvo is Methotrexat Lederle injection.
Maltese: Il-mediċina ta' referenza għal Jylamvo hija linjezzjoni Methotrexat Lederle.
English: The way methotrexate works in patients with arthritis and psoriasis is not completely understood, but the benefits of methotrexate are thought to be due to its ability to reduce inflammation and suppress an overactive immune system.
Maltese: Il-mod kif il-metotreksat taħdem f'pazjenti bl-artrite u l-psorjasi mhuwiex mifhum għal kollox, iżda lbenefiċċji tal-metotreksat huma maħsuba li huma dovuti għall-ħila tagħha li tnaqqas l-infjammazzjoni u trażżan sistema immunitarja attiva żżejjed.
English: The most common side effects with Jylamvo (which may affect more than 1 in 10 people) are effects in the digestive system (such as inflammation of the lining of the mouth, indigestion, belly pain, feeling sick and loss of appetite) and blood tests showing changes in the liver.
Maltese: L-effetti sekondarji l-aktar komuni b'Jylamvo (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma effetti fis-sistema diġestiva (bħal infjammazzjoni tal-kisja tal-ħalq, indiġestjoni, uġigħ ta' żaqq, tħossok ma tiflaħx u telf ta' aptit) u testijiet tad-demm li juru bidliet fil-fwied.
English: For the full list of side effects and restrictions of Jylamvo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Jylamvo, ara l-fuljett ta' tagħrif.
English: Why is Jylamvo authorised in the EU?
Maltese: Għaliex Jylamvo ġie awtorizzat fl-UE?
English: • acute lymphoblastic leukaemia (ALL), a cancer of white blood cells, in adults and children over the age of 3 years.
Maltese: • lewkimja limfoblastika akuta (ALL), kanċer taċ-ċelloli bojod tad-demm, fl-adulti u fit-tfal li għandhom aktar minn tliet snin.
English: • severe juvenile idiopathic arthritis (inflammation of joints in children) in patients from 3 years of age when NSAIDs (non-steroidal anti-inflammatory drugs) have not worked well enough;
Maltese: • artrite idjopatika ġuvenili severa (infjammazzjoni tal-ġogi fit-tfal) f'pazjenti minn tliet snin 'il fuq meta l-NSAIDs (prodott antinfjammatorju nonsterojdali) ma jkunux ħadmu tajjeb biżżejjed;
English: As for all medicines, data on the use of Jylamvo are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Jylamvo hija ssorveljata kontinwament.
English: The active substance in Jylamvo, methotrexate, stops cells from growing by interfering with the production of DNA.
Maltese: Is-sustanza attiva f'Jylamvo, il-metotreksat, twaqqaf iċ-ċelloli milli jikbru billi tinterferixxi malproduzzjoni tad-DNA.
English: The Agency therefore decided that Jylamvo's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: Għaldaqstant, lAġenzija ddeċidiet li l-benefiċċji ta' Jylamvo huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għallużu fl-UE.
English: The company also carried out studies that showed that it is bioequivalent to other methotrexate medicines used to treat inflammatory conditions and ALL (Methotrexat Lederle and Ebetrexat tablets).
Maltese: Il-kumpanija wettqet ukoll studji li wrew li huwa bijoekwivalenti għal mediċini oħrajn li fihom il-metotreksat li jintużaw għall-kura ta' infjammazzjonijiet u tal-ALL (Methotrexat Lederle u l-pilloli Ebetrexat).
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 web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi ta' aġġornament dwar is-sikurezza għal dan il-prodott skont ir-rekwiżiti stabbiliti fil-lista ta' dati ta' referenza tal-Unjoni (lista EURD) prevista fl-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikata fuq il-web-portal tal-mediċini Ewropej.
English: National Competent Authorities (NCAs) of Member State(s) or Reference Member State(s) (RMS) where applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Maltese: L-awtoritajiet nazzjonali kompetenti (NCAs) tal-Istat(i) Membru(i) jew l-Istat(i) Membru(i) ta' referenza jekk applikabbli, għandhom jiżguraw li l-kondizzjonijiet li ġejjin jiġu sodisfatti mill-MAH(s):
English: Annex IV Condition to the marketing authorisations
Maltese: Anness IV
English: It may harm them,
Maltese: Ġeneru sesswali u razza:
English: The study is to be monitored regularly by a Data Monitoring Committee (DMC).
Maltese: The study għandu be monitored regularly by a Data Monitoring Committee (DMC).
English: CI, Confidence Interval; LS, Least Squares.
Maltese: CI, (Confidence Interval) Intervall ta' Kunfidenza; LS, Least Squares.
English: This leaflet was last revised in {month YYYY}.
Maltese: Šī lietošanas instrukcija pēdējo reizi pārskatīta {GGGG. mēnesis}.
English: Suite 2 Stafford House, Strand Road, Portmarnock, Co. Dublin, Ireland
Maltese: Suite 2 Stafford House, Strand Road, Portmarnock, Co.
English: Reproduction toxicity:
Maltese: Tossiċità riproduttiva:
English: Uncommon Oral herpes (N), Tinea pedis (N)
Maltese: Mhux komuni Herpes orali (N), Tinea pedis (N)
English: Anxiety, Insomnia
Maltese: Ansjetà, Insomnija
English: • ≥ 30 kg/m2 (obese), or
Maltese: • ≥ 30 kg/m2 (obeżi), jew
English: OCT2 substrates
Maltese: Sottostrati ta' OCT2
English: * Difference from placebo, p<0.001 ** Difference from placebo, p<0.01
Maltese: * Differenza mill-plaċebo, p<0.001 ** Differenza mill-plaċebo, p<0.01
English: M.S. Jacovides & Co Ltd Tel: 800 90 819
Maltese: Jacovides & Co Ltd Tel: 800 90 819
English: INFORMATION IN BRAILLE mysimba
Maltese: INFORMAZZJONI BIL-BRAILLE mysimba
English: HbA1c, % Not applicable
Maltese: HbA1c, % Mhux applikabbli
English: The MAH should conduct and submit results of a multicentre, randomised, doubleblind, placebo-controlled, phase 4 study to assess the effect of naltrexone extended release (ER) /bupropion ER on the occurrence of major adverse cardiovascular events (MACE) in overweight and obese subjects.
Maltese: Id-Detentur al-Awtorizzazzjoni għat Tqegħid fis-Suq għandu jissottometti riżultati ta' multicentre, randomised, double-blind, placebo-controlled, phase 4 study to assess the effect of naltrexone extended release (ER) /bupropion ER on the occurrence of major adverse cardiovascular events (MACE) in overweight and obese subjects.
English: Uncommon Ataxia (B), Incoordination (B)
Maltese: Mhux komuni Atassija (B), Inkoordinazzjoni (B)
English: Naltrexone / bupropion contains bupropion.
Maltese: Naltrexone / bupropion fih bupropion.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Tablet core:
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti
English: * Difference from placebo, p<0.001.
Maltese: * Differenza mill-plaċebo, p<0.001
English: Naltrexone is primarily metabolized to 6-beta-naltrexol by the dihydrodiol dehydrogenases (DD1, DD2 and DD4).
Maltese: Naltrexone jiġi metabolizzat prinċipalment minn 6-beta naltrexol mid-dihydrodiol dehydrogenases (DD1, DD2 u DD4).
English: Film-coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc and indigo carmine aluminium lake (E132).
Maltese: Kisi tar-rita: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc u indigo carmine aluminium lake (E132).
English: CYP2D6 substrates
Maltese: Sottostrati ta' CYP2D6
English: Tablet core: microcrystalline cellulose, hydroxypropyl cellulose, lactose anhydrous, lactose monohydrate (see section 2 “Mysimba contains lactose”), cysteine hydrochloride, crospovidone, magnesium stearate, hypromellose, edetate disodium, colloidal silicon dioxide, and indigo carmine aluminium lake (E132).
Maltese: Il-qalba tal-pillola: microcrystalline cellulose, hydroxypropyl cellulose, lactose anhydrous, lactose monohydrate (ara sezzjoni 2 “Mysimba fih lactose”), cysteine hydrochloride, crospovidone, magnesium stearate, hypromellose, edetate disodium, colloidal silicon dioxide, u indigo carmine aluminium lake (E132).
English: Electrocardiogram change (N)
Maltese: Bidla fl-elettrokardjogramma (N)
English: LDL-C/HDL-C ratio
Maltese: Proporzjon LDL-C/HDLC
English: CYP2B6 inducers, inhibitors and substrates
Maltese: Indutturi ta' CYP2B6, impedituri u sottostrati
English: Monoamine oxidase inhibitors (MAOI)
Maltese: Impedituri ta' monoamine oxidase (MAOI)
English: CHEPLAPHARM Arzneimittel GmbH Tel. 0800-183-2002
Maltese: Arzneimittel GmbH Tel. 0800-183-2002
English: Bupropion is extensively metabolised with three active metabolites: hydroxybupropion, threohydrobupropion and erythrohydrobupropion.
Maltese: Bupropion huwa metabolizzat b'mod estensiv bi tliet metaboliti attivi: hydroxybupropion, threohydrobupropion u erythrohydrobupropion.
English: 95% confidence intervals calculated as LS Mean ± 1.96 × Standard Error.
Maltese: Intervalli ta' kunfidenza ta' 95% kkalkulati bħala Medja ta' LS ±1.96 x Errur Standard
English: • theophylline (used in the treatment of asthma);
Maltese: • theophylline (użat fit-trattament ta' ażma);
English: Acne, Erythema multiforme and Stevens Johnson syndrome
Maltese: Akne, Eritema multiforme u s-sindromu ta' Stevens-Johnson
English: Submission of the protocol by 31 March
Maltese: Sottomissjoni tal-protokoll sal-31 ta' Marzu 2015
English: EU/1/14/988/002 28 tablets
Maltese: EU/1/14/988/001-002
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 March 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 26 Marzu 2015
English: Pack sizes: 28, 112 tablets.
Maltese: Mysimba jiġi f'pakketti li jkun fihom 28, 112-il pillola.
English: CHEPLAPHARM Arzneimittel GmbH Tel. 0800-298403
Maltese: Arzneimittel GmbH Tel. 0800-298403
English: The mean volume of distribution at steady state of oral naltrexone and bupropion given as naltrexgone / bupropion, Vss/F, was 5697 liters and 880 liters, respectively.
Maltese: Il-volum medju ta' distribuzzjoni fl-istadju fiss ta' naltrexone u bupropion orali mogħtija bħala naltrexone / bupropion, VssF, kien ta' 5697 litru u 880 litru, rispettivament.
English: ** The incidence of seizures is approximately 0.1% (1/1,000).
Maltese: ** L-inċidenza ta' puplesiji hi madwar 0.1% (1/1,000).
English: Treatment adherence rates for the integrated Phase 3 studies were: 67% NB vs. 74% Placebo at 16 weeks, 63% NB vs. 65% Placebo at 26 Weeks, 55% NB vs. 55% Placebo at 52Weeks.
Maltese: Ir-rati ta' aderenza għall-kura għall-istudji integrati ta' Fażi 3 kienu: 67% NB vs. 74% Plaċebo wara 16-il ġimgħa, 63% NB vs. 65% Plaċebo wara 26 Ġimgħa, 55% NB vs. 55% Plaċebo wara 52 Ġimgħa.
English: In vitro findings suggest that CYP2B6 is the principal isozyme involved in the formation of hydroxybupropion, while CYP1A2, 2A6, 2C9, 3A4 and 2E1 are less involved.
Maltese: CYP2B6 huwa l-isoenzim prinċipali involut fil-formazzjoni ta' hydroxybupropion waqt li CYP1A2, 2A6, 2C9, 3A4 u 2E1 huma involuti inqas.
English: Mysimba with alcohol
Maltese: Mysimba mal-alkoħol
English: The types of tolerability events were similar to the events observed in patients with normal renal function (see sections 4.2, 4.4, and 5.2).
Maltese: It-tipi ta' każijiet ta' tollerabilità kienu simili għall-każijiet osservati f'pazjenti b'funzjoni tal-kliewi normali (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: The combination has not been tested in reproductive toxicity studies.
Maltese: Ilkombinazzjoni ma ġietx ittestjata fi studji ta' tossiċità riproduttiva.
English: Irregular menstruation, Vaginal haemorrhage, Vulvovaginal dryness
Maltese: Menstruwazzjoni irregolari, Emorraġija vaġinali, Nixfa vulvovaġinali
English: In clinical studies, 23.8% of subjects receiving naltrexone / bupropion and 11.9% of subjects receiving placebo discontinued treatment due to an adverse event.
Maltese: Fi studji kliniċi, 23.8% ta' individwi li ħadu naltrexone / bupropion u 11.9% tal-individwi li ħadu l-plaċebo waqqfu t-trattament minħabba reazzjoni avversa.
English: Colloidal Silicon Dioxide Film-coating:
Maltese: Colloidal Silicon Dioxide
English: Mysimba contains lactose (a type of sugar)
Maltese: Mysimba fih lactose (tip ta' zokkor)
English: Hyperhidrosis, Pruritus, Alopecia, Rash
Maltese: Iperidrosi, Ħakk, Alopeċja, Raxx
English: Adverse reactions of the individual components Naltrexone and Bupropion identified in the respective approved SmPCs.
Maltese: Ir-reazzjonijiet avversi tal-komponenti individwali Naltrexone u Bupropion identifikati fl-SmPCs approvati rispettivi.
English: Fasting glucose, mg/dL
Maltese: HDL-C, mg/dL
English: Accumulation:
Maltese: Akkumulazzjoni:
English: * P-value <0.05 (nominal values) compared to placebo group.
Maltese: * valur-p <0.05 (valuri nominala) meta mqabbel mal-grupp ta' plaċebo
English: Loss of consciousness, Paraesthesia, Presyncope, Seizure**, Syncope
Maltese: Tintilef minn sensik, Paraestesija, Presinkope, Puplesija**, Sinkope
English: The effects of cigarette smoking on the pharmacokinetics of bupropion were studied in 34 healthy male and female volunteers; 17 were chronic cigarette smokers and 17 were nonsmokers.
Maltese: L-effetti ta' tipjip tas-sigaretti fuq il-farmakokinetiċi ta' bupropion ġew studjati fi f'34 voluntier raġel u mara b'saħħithom, 17 kienu jpejpu s-sigaretti b'mod kroniku u 17 ma kinux ipejpu.
English: Table 4.
Maltese: Tabella 4:
English: The frequencies of adverse reactions are ranked according to the following: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: 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); mhux magħruf (ma jistax jiġi stmat mit-tagħrif disponibbli).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/988/001 112 tablets
Maltese: EU/1/14/988/001 112 -il pillola EU/1/14/988/002 28-il pillola
English: Uncommon Exacerbation of psoriasis (B), Seborrhea (N)
Maltese: Mhux komuni Aggravar ta' psorjasi (B), Seborrea (N)
English: Naltrexone was negative in the following in vitro genotoxicity studies: bacterial reverse mutation assay (Ames test), the heritable translocation assay, CHO cell sister chromatid exchange assay, and the mouse lymphoma gene mutation assay.
Maltese: Naltrexone ta' riżultat negattiv fl-istudji ġenotossiċi in vitro li ġejjin: assaġġ batteriku dwar mutazjoni riversabbli (Test ta' Ames), assaġġ ta' translok li jintiret, CHO cell sister chromatid exchange assay, u l-assaġġ ta' ġene ta' mutazzjoni ta' limfoma tal-ġurdien.
English: • Medicines used in the treatment of HIV infection and AIDS, such as efavirenz and ritonavir;
Maltese: • Mediċini użati fil-kura ta' infezzjoni tal-HIV u AIDS bħal efavirenz u ritonavir;
English: In a clinical study, naltrexone / bupropion (32 mg naltrexone hydrochloride /360 mg bupropion hydrochloride daily) was co-administered with a 50 mg dose of metoprolol (a CYP2D6 substrate).
Maltese: Fi studju kliniku, naltrexone / bupropion (32 mg naltrexone hydrochloride /360 mg bupropion hydrochloride kuljum) ingħataw fl-istess waqt b'doża ta' 50 mg ta' metoprolol (sottostrat ta' CYP2D6).
English: The fraction of the oral dose of bupropion excreted unchanged was 0.5%, a finding consistent with the extensive metabolism of bupropion.
Maltese: Il-porzjon tad-doża orali ta' bupropion eliminat mhux mibdul kien ta' 0.5%, riżultat konsistenti mal-metaboliżmu estensiv ta' bupropion.
English: More severe hypersensitivity reactions including angioedema, dyspnoea/ bronchospasm and anaphylactic shock.
Maltese: Reazzjonijiet ta' sensittività eċċessiva aktar severi inkluż anġjoedema, dispnea/ bronkospażmu u xokk anafilattiku.
English: In the combined Phase 3 studies, the mean age was 46 years, 83% were female, and 77% were White, 18% were Black and 5% were other races.
Maltese: Fl-istudji kombinati ta' Fażi 3, l-età medja kienet ta' 46 sena, 83% kienu nisa, u 77% kienu Bojod, 18% kienu Suwed u 5% kienu minn razez oħra.
English: Concentration disturbance (B)
Maltese: Disturb fil-konċentrazzjoni (B)
English: Blue, biconvex, round tablet of 12.0-12.2 mm diameter debossed with “NB-890” on one side.
Maltese: Pillola tonda, ta' lewn blu, bikonvessa b'dijametru ta' 12.0-12.2 mm b'”NB-890” intaljati fuq naħa waħda.
English: PharmaSwiss Hellas A.E. Τηλ: 008001 612 2030 465
Maltese: Τηλ: 008001 612 2030 465
English: ≥10% Weight
Maltese: Bidla %
English: Mysimba 8 mg/90 mg prolonged-release tablets naltrexone hydrochloride / bupropion hydrochloride
Maltese: Mysimba 8 mg/90 mg pilloli li jerħu l-mediċina bil-mod naltrexone hydrochloride / bupropion hydrochloride
English: Mean (95% CI)
Maltese: Bidla % Medja LS (95% CI) Mil-Linja
English: The incidence of these common gastrointestinal adverse reactions in naltrexone / bupropion versus placebo was as follows: nausea (31.8% vs. 6.7%), constipation (18.1% vs. 7.2%), and vomiting (9.9% vs. 2.9%).
Maltese: L-inċidenza ta' dawn ir-reazzjonijiet gastrointestinali komuni diversi meta mqabbla bejn naltrexone / bupropion mal-plaċebo kienu kif ġej: dardir (31.8 % vs 6.7 %), stitikezza (18.1 % vs 7.2 %) u remettar (9.9 % vs 2.9 %).