FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of naltrexone / bupropion with inhibitors or inducers of UGT 1A2 and 2B7 should be undertaken with caution as these may alter the exposure of naltrexone.
Maltese: UGT, 1A2 u 2B7 għandu jsir b'kawtela peress li dawn jistgħu jibdlu l-esponiment ta' naltrexone.
English: Although not metabolised by the CYP2D6 isoenzyme, bupropion and its main metabolite, hydroxybupropion, inhibit the CYP2D6 pathway and the potential exists to affect medicinal products metabolised by CYP2D6.
Maltese: CYP2D6 u teżisti l-possibilità li jiġu affettwati prodotti mediċinali meabolizzati b'CYP2D6.
English: • Some medicines used to treat high blood pressure (beta-blockers such as metoprolol, and clonidine, a centrally acting antihypertensive);
Maltese: • Xi mediċini użati biex jittrattaw il-pressjoni għolja tad-demm (imblokkaturi beta bħal metoprolol, u clonidine, mediċina li taġixxi kontra l-pressjoni għolja b'mod ċentrali);
English: Uncommon Postural hypotension (B), Vasodilatation (B)
Maltese: Mhux komuni Delużjonijiet (B), Depersonalizzazzjoni
English: Although in placebo-controlled clinical trials with naltrexone / bupropion for the treatment of obesity in adult subjects, no suicides or suicide attempts were reported in studies up to 56 weeks duration with naltrexone / bupropion, suicidality events (including suicidal ideation) have been reported in subjects of all ages treated with naltrexone / bupropion post-marketing.
Maltese: Għalkemm fi provi kliniċi bi plaċebo bħala kontroll b'naltrexone / bupropion għat-trattament talobeżità f'individwi adulti, l-ebda suwiċidju jew tentattiv ta' suwiċidju ma ġie rapportat fi studji wara 56 ġimgħa b'naltrexone / bupropion, avvenimenti ta' suwiċidalità (li jinkludu l-ħsieb ta' suwiċidju) ġew irrappurtati f'individwi ta' kull età ttrattati b'naltrexone / bupropion wara t-tqefħid fis suq.
English: Naltrexone/bupropion is not recommended in patients over 75 years of age.
Maltese: Naltrexone/bupropion mhux irrakkomandat għal pazjenti li għandhom aktar minn 75 sena.
English: As NB is a fixed combination of two active ingredients, in addition to the terms listed in Table 1, additional adverse reactions seen with one of the active substances may potentially occur.
Maltese: Peress li NB huwa kombinazzjoni fissa ta' żewġ ingredjenti attivi, minbarra t-termini elenkati f'Tabella 1, jistgħu potenzjalment iseħħu reazzjonijiet avversi addizzjonali li dehru b'waħda mis sustanzi attivi.
English: Lymphadenopathy
Maltese: Trigliċeridi
English: The most frequent adverse reactions for naltrexone / bupropion are nausea, constipation, vomiting, dizziness, and dry mouth.
Maltese: L-aktar reazzjonijiet avversi frekwenti għal naltrexone / bupropion kienu dardir, stitikezza, remettar, sturdament u ħalq xott.
English: • Patients with uncontrolled hypertension (see section 4.4)
Maltese: • Pazjenti bi pressjoni għolja mhix ikkontrollata (ara sezzjoni 4.4)
English: The safety and efficacy of naltrexone / bupropion in children and adolescents below 18 have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' naltrexone / bupropion fit-tfal u adolexxenti li għadhom m'għalqux it-18-il sena ma ġewx determinati s'issa.
English: Although clinical data do not identify a pharmacokinetic interaction between bupropion and alcohol, there have been rare reports of adverse neuropsychiatric events or reduced alcohol tolerance in patients drinking alcohol during bupropion treatment.
Maltese: Għalkemm it-tagħrif kliniku ma jidentifikax interazzjoni farmakokinetika bejn bupropion u alkoħol, kien hemm rapporti rari ta' każijiet newropsikjatriċi avversi jew tolleranza mnaqqsa għall-alkoħol f'pazjenti li jixorbu l-alkoħol waqt it-trattament bi bupropion.
English: The percentages of subjects with ≥ 5% or ≥ 10% body weight loss from baseline were greater with naltrexone / bupropion compared to placebo in all four Phase 3 obesity trials (Table 4).
Maltese: Il-perċentwali ta' individwi b'telf fil-piż tal-ġisem ta' ≥5% jew ≥10% mil-linja bażi kien akbar b'naltrexone / bupropion meta mqabbel ma' plaċebo fl-erba' provi ta' Fażi 3 dwar l-obeżità (Tabella 4)
English: In patients with mild hepatic impairment, the maximum recommended daily dose for naltrexone / bupropion is two tablets (one tablet in the morning and one tablet in the evening) (see sections 4.4 and 5.2).
Maltese: F'pazjenti b'indeboliment tal-fwied ħafif, id-doża massima ta' kuljum rakkomandata għal naltrexone / bupropion hija ta' żewġ pilloli (pillola waħda filgħodu u pillola waħda filgħaxija) (ara sezzjonijiet 4.4 u 5.2).
English: • Patients receiving any concomitant treatment containing bupropion or naltrexone
Maltese: • Pazjenti li jirċievu kull trattament konkomittanti li fih bupropion jew naltrexone
English: Dystonia, Memory impairment, Parkinsonism, Restlessness
Maltese: Sturdament, Rogħda, Disgewsja, Letarġija, Ngħas
English: Drugs which require metabolic activation by CYP2D6 in order to be effective (e.g., tamoxifen), may have reduced efficacy when administered concomitantly with inhibitors of CYP2D6 such as bupropion.
Maltese: Mediċini li jeħtieġu attivazzjoni metabolika b'CYP2D6 sabiex ikunu effettivi (eż. tamoxifen), jista' jkollhom effikaċja mnaqqsa meta jingħataw flimkien ma' impedituri ta' CYP2D6 bħal bupropion.
English: Lactose Anhydrous
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: NB-303 NB PBO NB PBO NB PBO NB PBO Intent-to-Treat Analysis Set+ N Baseline (kg) LS Mean (95% CI)
Maltese: Riżultati komparabbli ġew osservati fl-istudju NB-303, li kien ippjannat b'mod simili, b'telf fil-piż sinifikanti osservat f'individwi trattati b'naltrexone / bupropion meta mqabbla ma' plaċebo fil-punt aħħari prinċipali ta' riferiment ta' Ġimgħa 28, u sostnut għal tul 56 ġimgħa mil-linja bażi (Tabella 3).
English: Elderly patients may be more sensitive to some of the central nervous system-related adverse reactions of naltrexone / bupropion (primarily dizziness and tremor).
Maltese: Pazjenti anzjani jistgħu jkunu aktar sensittivi għal xi reazzjonijiet avversi ta' naltrexone / bupropion marbuta mas-sistema nervuża ċentrali (prinċipalment sturdament u rogħda).
English: If serum sickness is suspected, naltrexone / bupropion should be discontinued.
Maltese: Jekk mard tas-serum hu suspettat, naltrexone / bupropion għandu jitwaqqaf.
English: Effects on glycaemic control in obese subjects with type 2 diabetes After 56 weeks of treatment in subjects with type 2 diabetes (NB-304), naltrexone / bupropion exhibited improvements in glycaemic control parameters compared to placebo (Table 5).
Maltese: Wara 56 ġimgħa ta' trattament f'individwi b'dijabete ta' tip 2 (NB-304), naltrexone / bupropion urew titjib fil-parametri ta' kontroll gliċemiku meta mqabbla ma' plaċebo (Tabella 5).
English: Pharmacotherapeutic group: A08AA Centrally acting antiobesity products, ATC code: A08AA62 bupropion and naltrexone.
Maltese: A08AA62 bupropion u naltrexone.
English: Renal and Urinary Disorders
Maltese: Disturbi fil-Kliewi u fis-Sistema Urinarja
English: Following oral administration of a single 150 mg dose of bupropion hydrochloride, there was no statistically significant difference in Cmax, half-life, Tmax, AUC, or clearance of bupropion or its active metabolites between smokers and nonsmokers.
Maltese: Wara l-għoti mill-ħalq ta' doża waħda ta' 150 mg bupropion hydrochloride, ma kienx hemm differenza statistikament sinifikanti fil-half-life ta' Cmax, Tmax, AUC, jew tneħħija ta'
English: As it is unknown whether the risk for seizure with bupropion is related to bupropion or a metabolite of bupropion, and there are no data demonstrating comparability of plasma concentrations with repeated dosing, there is uncertainty whether repeated-dose administration naltrexone / bupropion may be associated with a similar rate of seizures as bupropion SR 300 mg.
Maltese: Peress li mhux magħruf jekk ir-riskju ta' attakk pupletiku b'bupropion hux relatat ma' bupropion jew ma' xi metabolit ta' bupropion, u m'hemmx tagħrif dwar il-komparabilità murija ta' konċentrazzjonijiet fil-plażma ta' dożi ripetuti, hemm inċertezza jekk lgħoti ripetut ta' naltrexone / bupropion jistax ikun assoċjat ma' rata simili ta' puplesiji bħal bupropion SR 300 mg.
English: For individuals who are at elevated risk for renal impairment, in particular patients with diabetes or elderly individuals, estimated glomerular filtration rate (eGFR) should be assessed prior to initiating therapy with naltrexone / bupropion.
Maltese: filtrazzjoni glomerulari (estimated glomerular filtration rate) għandha tiġi assessjata qabel ma tibda tingħata t-terapija b'naltrexone / bupropion.
English: Mean Weight Loss (% Change) from Baseline to Week 56 in Naltrexone / Bupropion (NB) Phase 3 Studies NB-301, NB-302, and NB-304 and from Baseline to Week 28 in Phase 3 Study NB-303
Maltese: NB-301, NB-302 u NB-304 fi studji ta' Fażi 3 b'Naltrexone / Bupropion u mil-Linja Bażi sa Ġimgħa 26 fl-Istudju ta' Fażi 3 NB-303
English: Uncommon Sputum increased (N)
Maltese: Tnaqqis fl-aptit (N)
English: Renal impairment: A single-dosepharmacokinetic study has been conducted for naltrexone / bupropion in subjects with mild, moderate, and severe renal impairment, compared with subjects with normal renal function.
Maltese: Indeboliment tal-kliewi: Sar studju farmakokinetiku dwar dożi waħidhom għal naltrexone / bupropion f'individwi b'indeboliment ħafifa, moderat, u sever tal-kliewi, meta mqabbla ma' individwi b'funzjoni normali tal-kliewi.
English: • Week 4 and onwards: Two tablets in the morning and two tablets in the evening The maximum recommended daily dose of Mysimba is two tablets taken twice daily for a total dose of 32 mg naltrexone hydrochloride and 360 mg bupropion hydrochloride.
Maltese: Id-doża massima rakkomandata għal kuljum ta' Mysimba hi ta' żewġ pilloli kuljum għal doża totali ta' 32 mg naltrexone hydrochloride u 360 mg bupropion hydrochloride.
English: Studies NB-301, NB-302, and NB-303 were conducted in subjects who were obese, or overweight or obese with comorbidities.
Maltese: NB-301, NB-302, u NB-303 saru f'individwi li kienu obeżi, jew ta' piż żejjed jew obeżi b'komorbiditajiet.
English: Naltrexone / bupropion should be used with caution in patients over 65 years of age and is not recommended in patients over 75 years of age (see sections 4.4, 4.8 and 5.2).
Maltese: Naltrexone / bupropion għandu jintuża b'kawtela f'pazjenti li għandhom 65 sena u aktar u mhux rakkomandat għal pazjenti li għandhom 75 sena u aktar (ara sezzjonijiet 4.4, 4.8 and 5.2).
English: Effect on cardiovascular and metabolic parameters Improvements were observed for waist circumference (including subjects with type 2 diabetes), triglycerides, HDL-C and LDL-C/HDL-C ratio for subjects treated with naltrexone / bupropion vs. placebo in all Phase 3 studies (Table 5).
Maltese: HDL-C u l-proporzjon LDL-C/HDL.C għal individwi trattati b'naltrexone / bupropion vs plaċebo flistudji kollha ta' Fażi 3 (Tabella 5).
English: Acute ingestion of doses in excess of 10 times the maximum therapeutic dose of bupropion (equivalent to approximately in excess of 8 times the recommended daily dose of naltrexone / bupropion) has been reported.
Maltese: Ġiet irrapportata inġestjoni akuta għal dożi akbar minn 10 darbiet id-doża terapewtika massima ta' bupropion (ekwivalenti għal madwar aktar minn 8 darbiet id-doża rakkomandata ta' kuljum ta' naltrexone / bupropion).
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal gallatosju, id-defiċjenza ta' Lactase totali jew malassorbiment tal-glukosju-gallatosju m'għandhomx jieħdu dan il-prodott mediċinali.
English: 6.4 Special precautions for storage Do not store above 30°C.
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Taħżinx f'temperatura ‘l fuq minn 30ºC.
English: Increases of ~2- and ~4-fold for the area under the curve for bupropion were observed for patients with moderate and severe impairment respectively.
Maltese: Ġew osservati żidiet ta' ~2 u ~4 darbiet għall-erja taħt il-kurva għal bupropion għal pazjenti b'indeboliment moderat u sever rispettivament.
English: Cardiovascular disease
Maltese: Disturbi gastro-intestinali
English: Mysimba contains 2 active substances: naltrexone hydrochloride and bupropion hydrochloride and is used in obese or overweight adults to manage weight together with a reduced calorie diet and physical exercise.
Maltese: Mysimba fih 2 sustanzi attivi, naltrexone hydrochloride u bupropion hydrochloride u jintuża minn adulti obeżi jew b'piż żejjed biex jiġġestixxu l-piż flimkien ma' dieta b'ammont imnaqqas ta' kaloriji u b'eżerċizzju fiżiku.
English: (angioedema) - Excessive loss of body water (dehydration) - Hallucinations - Fainting, almost fainting (presyncope), loss of consciousness - Fits - Passage of fresh blood through the anus usually in or with stool (haematochezia) - Projection of an organ or the tissue encompassing an organ through the wall of the cavity that normally contains it (hernia) - Toothache - Dental caries, cavities - Pain in the lower part of the abdomen - Injury to the liver due to drug toxicity - Jaw pain - A disorder characterised by a sudden compelling urge to urinate (micturition urgency) - Irregular menstrual cycle, vaginal bleeding, dryness of the female vulva and vagina
Maltese: - Uġigħ fil-parti t'isfel taż-żaqq - Korriment fil-fwied minħabba tossiċità tal-mediċina - Uġigħ fix-xedaq - Disturb karaterizzat minn xenqa irresistibbli f'daqqa biex tgħaddi l-awrina (urġenza minzjonali) - Ċiklu menstruwali irregolari, emorraġija vaġinali, il-vulva u l-vaġina xotti
English: Summaries of the proportion of subjects achieving ≥5% or ≥10% reduction in body weight utilize a baseline observation carried forward (BOCF) analysis of all randomized subjects.
Maltese: Sommarji tal-proporzjon ta' individwi li kisbu tnaqqis ta' ≥5% jew ≥10% fil-piż tal-ġisem permezz ta' analiżi dwar ta' osservazzjoni ta' riferiment immexxija ‘l quddiem
English: Elderly people: The pharmacokinetics of naltrexone / bupropion have not been evaluated in the elderly population.
Maltese: Il-farmakokinetiċi ta' naltrexone / bupropion me ġewx evalwati fil-popolazzjoni anzjana.
English: Arthralgia, myalgia, and fever with rash and other symptoms suggestive of delayed hypersensitivity have been reported in association with bupropion.
Maltese: Artralġja, mijalġja, u deni bir-raxx huma sintomi oħrajn li jissuġġerixxu sensittività eċċessiva mdewwma li ġew rapportati flimkien ma' bupropion.
English: Each tablet contains 8 milligrams of naltrexone hydrochloride, equivalent to 7.2 milligrams of naltrexone, and 90 milligrams of bupropion hydrochloride, equivalent to 78 milligrams of bupropion.
Maltese: X'fih Mysimba - Is-sustanzi attivi huma naltrexone hydrochloride u bupropion hydrochloride Kull pillola fiha 8 milligrammi naltrexone hydrochloride, ekwivalenti għal 7.2 milligrammi ta' neltrexone, u 90 milligramma bupropion hydrochloride, ekwivalenti għal 78 milligramma ta' bupropion.
English: Naltrexone / bupropion is contraindicated in patients with end-stage renal failure.
Maltese: Naltrexone / bupropion hu kontraindikat f'pazjenti b'falliment tal-kliewi tal-aħħar stadju.
English: Type 2 diabetes
Maltese: Dijabete ta' tip 2
English: Arthralgia, myalgia and fever have also been reported in association with rash and other symptoms suggestive of delayed hypersensitivity.
Maltese: Artralġja, mijalġja u deni ġew ukoll irrappurtati b'rabta ma' raxx u sintomi oħra li jissuġġerixxu sensittività eċċessiva mdewma.
English: Blood and Lymphatic system disorders Uncommon Idiopathic thrombocytopenic purpura (N) Immune system disorders
Maltese: Mhux komuni Purpura tromboċitopenika idjopatika (N)
English: (photophobia) - Ear pain, ear discomfort - Fluctuating blood pressure - Difficulty in breathing - Nasal discomfort, congestion, runny nose, sneezing, sinus disorder - Sore throat, disorder of the voice, cough, yawning - Haemorrhoids, ulcer - Diarrhoea - Passing wind (flatulence) - Hepatitis - Acne - Groin pain - Muscle pain - Joint pain - Abnormally frequent urination, painful urination - Chills - Increased energy
Maltese: - Sensittività eċċessiva - Ħolma abnormali - Tħossok nervuż/a, tħossok distanti, tensjoni, aġitazzjoni, bidliet fil-burdata - Rogħda fir-ras jew driegħ jew riġel li tiżdied meta tipprova twettaq xi funzjoni partikolari
English: • Patients currently dependent on chronic opioids (see sections 4.4 and 4.5) or opiate agonists
Maltese: • Pazjenti b'indeboliment tal-fwied sever (ara sezzjonijiet 4.2 u 5.2)
English: Other side effects include:
Maltese: Persuni anzjani:
English: Naltrexone and bupropion are known to be substantially excreted by the kidney, and the risk of adverse reactions to naltrexone / bupropion may be greater in patients with impaired renal function, a condition that is more common in elderly individuals.
Maltese: Naltrexone u bupropion huma magħrufa li huma eliminati b'mod sostanzjali mill-kliewi, u r-riskju ta' reazzjonijiet avversi għal naltrexone / bupropion jista' jkun ogħla f'pazjenti b'indeboliment fil-funzjoni tal-kliewi, kundizzjoni li hi aktar komuni f'individwi anzjani.
English: ++ Subjects who have a baseline and a post-baseline body weight measurement and completed 56 weeks (Studies NB-301, NB-302, and NB-304) or 28 weeks (NB-303) of treatment.
Maltese: NB-301, NB-302, u NB-304) jew 28 ġimgħa (NB-303) ta' trattament.
English: The clinical consequences of the inhibition of the metabolism of bupropion via CYP2B6 enzyme and the consequent changes in the bupropion-hydroxybupropion ratio are currently unknown, but could potentially lead to reduced efficacy of naltrexone / bupropion.
Maltese: Il-konsegwenzi kliniċi tal-impediment tal-metaboliżmu ta' bupropion permezz tal-enzima CYP2B6 u l-bidliet konsegwenzjali fil-proporzjon bupropion-hydroxybupropion attwalment m'humiex magħrufa,imma potenzjalment jistgħu jwasslu għal effikaċja mnaqqsa ta' naltrexone / bupropion.
English: Plasma protein binding of hydroxybupropion is similar to that of bupropion (84%) whereas the other two metabolites have approximately half the binding.
Maltese: Ir-rabta ta' proteini fil-plażma ta' hydroxybupropion hija simili għal dik ta' bupropion (84%) filwaqt li ż-żewġ metaboliti l-oħra għandhom madwar nofs l-irbit.
English: How to take Mysimba
Maltese: Tiħux Mysimba ma'
English: Uncommon side effects (may affect up to 1 in 100 people): - Hives (uticaria) - Hypersensitivity - Abnormal dreams, - Feeling nervous, feeling spacey, tension, agitation, mood swings, Tremor of the head or a limb which increases when trying to perform a particular function (intention tremor) - Balance disorder - Loss of memory (amnesia), Tingling or numbness of the hands or feet - Motion sickness - Burping - Abdominal discomfort - Indigestion - Inflammation of the gallbladder (cholecystitis) - Increased creatinine levels in the blood (indicating loss of kidney function) - Increased liver enzymes and bilirubin levels, liver disorders - Difficulty in getting or keeping an erection - Feeling abnormal, weakness (asthenia) - Thirst, feeling hot - Chest pain - Increased appetite, weight gain
Maltese: L-aktar tip komuni ta' attakki pupletiċi hija l-attakki toniċi-kloniċi ġeneralizzati, tip ta' attakk pupletiku li jista' jirriżulta f'xi każijiet ta' konfużjoni post-iktali jew indeboliment fil-memorja (ara sezzjoni 4.4) *** Uġigħ fis-snien u karje dentali, filwaqt li ma jissodisfawx il-kriterji għall-inklużjoni f'din it tabella, huma elenkati abbażi tas-subsett ta' pazjenti b'ħalq xott, li fihom ġiet osservata inċidenza ogħla ta' uġigħ fis-snien u karje dentali f'individwi kkurati b'NB kontra plaċebo.
English: Binding of β-endorphin to mu-opioid receptors on POMC neurons mediates a negative feedback loop on POMC neurons leading to a decrease in the release of α-MSH.
Maltese: L-effetti tal-użu kkombinat ta' bupropion u naltrexone ma ġewx studjati fl-annimali.
English: Swallow your tablets whole.
Maltese: Ibla' l-pilloli sħaħ.
English: Studies with naltrexone in animals have shown reproductive toxicity (see section 5.3); animal studies with bupropion show no clear evidence of reproductive harm.
Maltese: Studji b'naltrexone f'annimali wrew effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3): studji f'annimali bi bupropion ma jurux evidenza ċara ta' ħsara fuq is-sistema riproduttiva.
English: Cardiac rhythm and vital signs should be monitored.
Maltese: Ir-rittmu kardijaku u s-sinjali vitali għandhom jiġu monitorati.
English: Genotoxicity:
Maltese: Ġenotossiċità:
English: No specific antidotes for combined use of bupropion and naltrexone are known.
Maltese: M'hemmx antidoti speċifiċi għal użu kombinat ta' bupropion u naltrexone.
English: Hepatobiliary Disorders
Maltese: Mhux applikabbli
English: Based on its half-life, 6-beta-naltrexol is estimated to reach steady state concentrations in approximately 3 days.
Maltese: Abbażi tal-half-life tiegħu, 6-beta-naltrexol huwa stmat li jilħaq konċentrazzjonijiet ta' stadju fiss f'madwar 3 ijiem.
English: • Patients with a current or previous diagnosis of bulimia or anorexia nervosa
Maltese: • Pazjenti b'dijanjosi attwali jew preċedenti ta' bulimja jew anoreksja nervosa.
English: Ear discomfort, Ear pain
Maltese: - Konfużjoni, disorjentament
English: Hepatic impairment
Maltese: Lactose Anidru
English: - Feeling shaky (tremor) - Difficulty in sleeping (make sure you do not take Mysimba near to bedtime) - Changes in the taste of food (dysgeusia), dry mouth - Difficulty concentrating - Feeling of tiredness (fatigue) and sleepiness, drowsiness or lack of energy (lethargy) - Ringing in the ears (tinnitus) - Fast or irregular heartbeat - Hot flush - Increased blood pressure (sometimes severe) - Pain in the upper part of the abdomen - Pain in the abdomen - Excessive sweating (hyperhidrosis) - Rash, itching (pruritus) - Hair loss (alopecia) - Irritability - Feeling jittery
Maltese: - Stordament, tħossok stordut jew tħoss rasek iddur bik (vertiġni) - Tħossok titriegħed (rogħda) - Diffikultà biex torqod (kun żgur li ma tieħux Mysimba qrib il-ħin tal-irqad) - Bidliet fit-togħma tal-ikel (disgewsja), ħalq xott - Diffikultà biex tikkonċentra - Tħossok għajjien (għeja) u ngħas, ħedla jew nuqqas t'enerġija (letarġija)
English: Opioid analgesics
Maltese: - Uġigħ fil-muskoli
English: These symptoms may resemble serum sickness.
Maltese: Dawn is-sintomi jistgħu jixbħu l-mard tas serum.
English: In addition, in subjects who did not have type 2 diabetes, there were reductions in fasting insulin and HOMA-IR, a measure of insulin resistance, in naltrexone / bupropion-treated subjects.
Maltese: Barra minn hekk, f'individwi li ma kellhomx dijabete ta' tip 2, kien hemm tnaqqis fillivelli ta' insulina waqt is-sawm u fl-HOMR-IR, kejl tar-reżistenza tal-insulina, f'individwi trattati b'naltrexone / bupropion.
English: 09 October 2013
Maltese: 09 ta' Ottubru 2013
English: What is Methylphenidate Hexal?
Maltese: X'inhu Methylphenidate Hexal?
English: Questions and answers on Methylphenidate Hexal (methylphenidate hydrochloride, prolonged-release tablet 18, 36 and 54 mg)
Maltese: Mistoqsijiet u tweġibiet dwar Methylphenidate Hexal (methylphenidate hydrochloride, pillola li terħi l-mediċina bil-mod, 18, 36 u 54 mg)
English: Methylphenidate Hexal is a generic medicine based on a ‘reference medicine', Concerta, which is authorised in all the EU Member States.
Maltese: Methylphenidate Hexal huwa mediċina ġenerika bbażata fuq ‘mediċina ta' referenza', Concerta, li hija awtorizzata fl-Istati Membri kollha tal-UE.
English: Hexal A/S submitted Methylphenidate Hexal for mutual recognition on the basis of the initial authorisation granted by Denmark on 29 March 2012 and also valid through a decentralised procedure in Ireland.
Maltese: Hexal A/S ippreżenta Methylphenidate Hexal għal rikonoxximent reċiproku abbażi tal-awtorizzazzjoni inizjali li ngħatat mid-Danimarka fid-29 ta' Marzu 2012 u wkoll valida permezz ta' proċedura deċentralizzata fl-Irlanda.