FrancophonIA/ELRC3.0 huggingface dataset:
English: Prolonged-release exenatide is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance <30 ml/min) (see section 4.4).
Maltese: Exenatide li jerħi l-mediċina bil-mod mhuwiex irrakkomandat għall-użu f'pazjenti b'mard renali talaħħar stadju jew b'indeboliment renali sever (tneħħija tal-kreatinina ta' <30 ml/min) (ara sezzjoni 4.4).
English: • Bydureon BCise pen • Alcohol swab • A clean, flat surface • Puncture-resistant container (see “disposal” instructions at the end of these instructions) STEP 1: Prepare for injection
Maltese: • Pinna ta' Bydureon BCise • Swab tal-alkoħol • Wiċċ nadif u ċatt • Reċipjent li jiflaħ għat-titqib (ara istruzzjonijiet dwar ir-“rimi” fl-aħħar ta' dawn l-istruzzjonijiet) PASS 1: Ipprepara għall-injezzjoni
English: Patients who developed antibodies to exenatide tend to have more injection site reactions (for example: redness of skin and itching), but otherwise similar rates and types of adverse events as those with no antibodies to exenatide.
Maltese: ħmura fil-ġilda u ħakk), iżda mill-bqija kellhom rati u tipi ta' avvenimenti avversi simili għal dawk li ma kellhomx antikorpi għal exenatide.
English: As blood glucose concentrations decrease, insulin secretion subsides.
Maltese: Kif il-konċentrazzjonijiet tal-glucose fid-demm jonqsu, tonqos is-sekrezzjoni tal-insulina.
English: SE = standard error, CI = confidence interval, * p < 0.05, **p < 0.0001
Maltese: SE = devjazzjoni standard, CI = intervall ta' kunfidenza), * p <0.05, **p <0.
English: UNIQUE IDENTIFIER -HUMAN READABLE DATA
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Test your blood glucose levels regularly.
Maltese: Iċċekkja regolarment il-livelli ta' glucose fid-demm.
English: Dizziness
Maltese: Għatu
English: For prolonged-release exenatide treated patients, the incidence of potentially immunogenic injection site reactions (most commonly pruritus with or without erythema) during the 30-week and the two 26-week studies was 9%.
Maltese: Għall-pazjenti kkurati b'exenatide li jerħi l-mediċina bil-mod, l-inċidenza tar-reazzjonijiet fis-sit talinjezzjoni li potenzjalment huma immunoġeniċi (l-iżjed komuni ħakk b'eritema jew mingħajrha) waqt l-istudju tat-30 ġimgħa u t-tnejn ta' 26 ġimgħa, kienet ta' 9%.
English: HbA1c 7%
Maltese: HbA1c medja (%)
English: In the 30-week immediate-release exenatide comparator study both prolonged-release and immediate-release exenatide significantly reduced systolic blood pressure from baseline (4.7±1.1 mmHg and 3.4±1.1 mmHg, respectively); the difference between the treatments was not significant.
Maltese: Fl-istudju ta' 30 ġimgħa b'exenatide li jerħi l-mediċina b'mod immedjat darbtejn kuljum bħala komparatur, kemm exenatide li jerħi l-mediċina bilmod u exenatide li jerħi l-mediċina b'mod immedjat naqqsu b'mod sinifikanti l-pressjoni sistolika taddemm mil-linja bażi (4.7±1.1 mmHg u 3.4±1.1 mmHg rispettivament).
English: How do I know that the medicine is mixed well?
Maltese: Kif inkun naf li tajt lili nnifsi d-doża sħiħa tal-mediċina?
English: The results of long-term clinical studies of prolonged-release exenatide are presented below; these studies comprised 1356 subjects treated with prolonged-release exenatide, 52% men and 48% women; 230 subjects (17%) were ≥ 65 years of age.
Maltese: Ir-riżultati ta' studji kliniċi fit-tul ta' exenatide li jerħi l-mediċina bil-modhuma murija hawn taħt, dawn l-istudji kienu jikkonsistu minn 1356 individwu kkurati b'exenatide li jerħi l-mediċina bil-mod, 52% irġiel u 48% nisa; 230 individwu (17%) kellhom ≥ 65 sena.
English: The mean apparent clearance of exenatide is 9 l/h.
Maltese: It-tneħħija medja evidenti ta' exenatide hi ta' 9 l/siegħa.
English: During the controlled period of the clinical study comparing Bydureon BCise with immediate-release exenatide, nausea was reported in 9.6% and 20.5% of patients in each group.
Maltese: Waqt il-perjodu kkontrollat tal-istudju kliniku li qabbel Bydureon BCise ma' exenatide li jerħi l-mediċina b'mod imedjat, it tqalligħ ġie rrappurtat f'9.6% u 20.
English: Bydureon 2 mg powder and solvent for prolonged-release suspension for injection
Maltese: Bydureon 2 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod
English: Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjoni 5.2 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: Adverse reactions that have been observed with the prolonged-release exenatide but not in clinical studies with Bydureon BCise are also included in Table 1.
Maltese: Irreazzjonijiet avversi li ġew osservati b'exenatide li jerħi l-mediċina bil-mod iżda mhux fl-istudji kliniċi b'Bydureon BCise huma inklużi wkoll f'Tabella 1.
English: In 30-week placebo-controlled clinical studies with immediate-release exenatide, concomitant use of exenatide and HMG CoA reductase inhibitors was not associated with consistent changes in lipid profiles (see section 5.1).
Maltese: Fi studji kliniċi ta' 30 ġimgħa kkontrollati bi plaċebo b'exenatide li jerħi l-mediċina b'mod immedjat, l-użu flimkien ta' exenatide u l-inibituri ta' HMG CoA reductase ma kienx assoċjat ma' tibdil konsistenti fil-profili tallipidi (ara sezzjoni 5.1).
English: Air bubbles in syringe
Maltese: Żommha dritta u ħoll sew
English: There have been spontaneously reported events of acute pancreatitis with prolonged-release exenatide.
Maltese: B'mod spontanju, ġew irrapportati avvenimenti ta' pankreatite akuta b'exenatide li jerħi l-mediċina bil-mod.
English: Solvent: clear, colourless to pale yellow to pale brown solution.
Maltese: Solvent: soluzzjoni ċara, bla kulur għall-isfar ċar għall-kannella ċar.
English: You may use a biohazard container, another hard plastic container, or a metal container.
Maltese: Tista' tuża reċipjent talbioperiklu, reċipjent tal-plastik iebes ieħor, jew reċipjent tal-metall.
English: Require third-party assistance to resolve because of impairment in consciousness or behaviour and has glucose value of <54 mg/dL (3 mmol/L) OR 3.
Maltese: Jeħtieġu assistenza minn parti terza biex jiġu riżolti minħabba indeboliment fil-koxjenza jew fl-imġiba u għandu valur ta' glukożju ta' <54 mg/dL (3 mmol/L) JEW 3.
English: The prolonged-release exenatide and dapagliflozin treatment group showed superior reductions in HbA1c from baseline compared to prolonged-release exenatide alone and dapagliflozin alone (Table 7).
Maltese: Il-grupp ta' kura b'exenatide li jerħi l-mediċina bil-mod u dapagliflozin wera tnaqqis superjuri fl-HbA1c mil-linja bażi meta mqabbel ma' exenatide li jerħi l-mediċina bil-mod waħdu u dapagliflozin waħdu (Tabella 7).
English: There were no episodes of major hypoglycaemia in the prolonged-release exenatide with insulin group.
Maltese: Neħħih minn idejk biex tużah aktar 'il quddiem.
English: All treatment groups had a reduction in HbA1c compared to baseline.
Maltese: Kull grupp ta' kura kellu tnaqqis sinifikanti fl-fl-HbA1c meta mqabbel mal-linja bażi.
English: Resolution of pancreatitis has been observed with supportive treatment, but very rare cases of necrotising or haemorrhagic pancreatitis and/or death have been reported.
Maltese: Ġie osservat li b'kura ta' sostenn, il-pankreatite tirriżolva ruħha iżda ġew irrapportati każijiet rari ħafna ta' pankreatite nekrotizzanti jew emorraġika u/jew mewt.
English: B. Twist knob to release injection button.
Maltese: L-injezzjoni lesta biex neħodha.
English: The risk of hypoglycaemia was increased when prolonged-release exenatide was used in combination with a sulphonylurea in clinical studies.
Maltese: Sabiex tnaqqas ir-riskju ta' ipogliċemija assoċjata mal-użu ta' xi sulphonylurea, wieħed għandu jikkonsidra jnaqqas id-doża tas-sulphonylurea.
English: Shake Hard
Maltese: Mhux Imħallta
English: Blue cap Needle Needle Cover
Maltese: Tidher kappa ħadra
English: This medicine is available in pack of 4 single-dose pre-filled pens, and a multipack containing 12 (3 packs of 4) single-dose pre-filled pens.
Maltese: Din il-mediċina tiġi f'daqs ta' pakkett ta' 4 pinen mimlijin għal-lest ta' doża waħda u pakkett multiplu li fih 12 (3 pakketti ta' 4)-il pinna mimlijin għal-lest ta' doża waħda.
English: The orange connector will keep it attached to the syringe.
Maltese: Il-konnekter oranġjo jzommu mwaħħal mas-siringa.
English: After the suspension is fully mixed, the preparation steps must be completed immediately and the suspension injected subcutaneously.
Maltese: Wara li s-sospensjoni titħallat sew, għandhom jitkomplew il-passi tal-preparazzjoni immedjatament u s-sospensjoni għandha tiġi injettata taħt il-ġilda.
English: Single-dose kit
Maltese: TIKKETTA TAL-KUNJETT
English: BCise is the name of the pre-filled pen device used to inject your Bydureon medicine.
Maltese: • Aħżen fil-pakkett oriġinali sabiex tilqa' mid-dawl.
English: A. Inject and hold:
Maltese: Injetta u żomm:
English: Change from baseline (± SE) Mean difference in change from baseline versus sitagliptin (95% CI) Mean difference in change from baseline versus placebo (95% CI) Patients (%) achieving HbA1c < 7% Mean body weight (kg)
Maltese: Meta din il-mediċina tintuża ma' mediċina li fiha sulphonylurea, jistgħu jseħħu episodji ta' zokkor baxx fid-demm (ipogliċemija, ġeneralment ħafifa għal moderata).
English: • The pen may be kept for up to 4 weeks below 30°C prior to use.
Maltese: • Il-pinna tista' tinżamm għal mhux aktar minn 4 ġimgħat f'temperatura taħt 30ºC qabel l-użu.
English: There have been spontaneously reported cases of increased INR (International Normalised Ratio), sometimes associated with bleeding, with concomitant use of warfarin and exenatide (see section 4.5).
Maltese: Ġew irrapportati b'mod spontanju każijiet ta' żieda fl-INR (Proporzjon Normalizzat Internazzjonali), xi kultant assoċjat ma' fsada, fil-biċċa l-kbira bl-użu fl-istess ħin ta' warfarin u exenatide (ara sezzjoni 4.5).
English: In clinical studies of prolonged-release exenatide, approximately 45% of patients had low titre antibodies to exenatide at study endpoint.
Maltese: Fl-istudji kliniċi ta' exenatide li jerħi l-mediċina bil-mod, madwar 45% tal-pazjenti kellhom livell baxx ta' antikorpi kontra exenatide fl-aħħar tal-istudju.
English: When exenatide was used in combination with metformin and/or a thiazolidinedione, no increase in the incidence of hypoglycaemia was observed over that of placebo in combination with metformin and/or a thiazolidinedione which may be due to this glucose-dependent insulinotropic mechanism (see section
Maltese: Meta exenatide li jerħi l-mediċina bil-mod jiżdied mat-terapija eżistenti ta' metformin u/jew thiazolidinedione, id-doża attwali ta' metformin u/jew thiazolidinedione tista' tinżamm.
English: SN: NN:
Maltese: Tel.:
English: Prolongedrelease exenatide 2 mg
Maltese: Kull pinna mimlija għal-lest fiha 2 mg exenatide.
English: A complete relief of migraine attacks was achieved in 45% of patients, while a reduction of migraine attacks by at least 50% occurred in 18% patients.
Maltese: 45% tal-pazjenti kisbu solliev komplet mill-attakki tal-emigranja, filwaqt li fi 18% tal-pazjenti kien hemm tnaqqis ta' mill-inqas 50% fl-attakki tal-emigranja.
English: A total of 30 cases related to fibrotic events have been reported.
Maltese: Kienu rrappurtati total ta' 30 każ relatati ma' avvenimenti fibrotiċi.
English: On 18 January 2012, France triggered a referral under Article 31 of Directive 2001/83/EC for the following ergot derivatives containing medicinal products: dihydroergocryptine/caffeine, dihydroergocristine, dihydroergotamine, dihydroergotoxine and nicergoline.
Maltese: Fit-18 ta' Jannar 2012, Franza tat bidu għal riferiment skont l-Artikolu 31 tad-Direttiva 2001/83/KE għall-prodotti mediċinali li ġejjin li fihom derivati tal-ergotina: dihydroergocryptine/kafeina, dihydroergocristine, dihydroergotamine, dihydroergotoxine u nicergoline.
English: Therefore, in accordance with Article 116 of Directive 2001/83/EC, the CHMP recommends:
Maltese: Għalhekk, skont l-Artikolu 116 tad-Direttiva 2001/83/KE s-CHMP jirrakkomanda:
English: Ninety (90) cases were found to contain terms potentially indicative of symptoms or ergotism, such as paraesthesia, formication, tingling, intestinal/cerebrovascular/peripheral/tongue ischaemia, angina pectoris, coronaropathy, thoracic pain, nausea, vomiting, diarrhoea, abdominal pain, cold sensation, thrombosis, stroke, gangrene, necrosis, vasoconstriction/vasospasm, cyanosis, myalgia, muscular cramps, pain in extremities, vertigo, hypoaesthesia, numbness, headache, confusion, hallucinations.
Maltese: Disgħin (90) każ instabu li fihom termini potenzjalment indikattivi ta' sintomi jew ergotiżmu, bħal parasteżija, formikazzjoni, tnemnim, iskemija intestinali/ċerebrovaskulari/periferali/tal-ilsien, anġina pectoris, koronaropatija, uġigħ toraċiku, dardir, rimettar, dijarea, uġigħ addominali , sensazzjoni ta' kesħa, trombożi, puplesija, kankrena, nekrożi, vażokostrizzjoni/vażospażmi, ċijanożi, mijalġja, bugħawwieġ, uġigħ fl-estremitajiet, vertiġini, ipoestesija, tnemnim, uġigħ ta' ras, konfużjoni, alluċinazzjonijiet.
English: The CHMP considered the MAH's proposal for risk minimisation measures: the inclusion of information related to fibrosis and ergotism in section 4.4 of the Summary of Product Characteristics.
Maltese: Is-CHMP ikkunsidra l-proposta tal-MAHs għal miżuri ta' minimizzazzjoni tar-riskji: l-inklużjoni ta' informazzjoni relatata mal-fibrożi u l-ergotiżmu fis-sezzjoni 4.4 tas-Sommarju tal-Karatteristiċi talProdott.
English: − Acute retinopathies of vascular origin.
Maltese: − Retinopatiji akuti ta' oriġini vaskulari.
English: Patients were given 10 mg of nicergoline three times daily for the first 10 days followed by 5 mg three times daily for 3-5 weeks.
Maltese: Il-pazjenti ngħataw 10 mg ta' nicergoline tliet darbiet kuljum għallewwel 10 ijiem segwiti minn 5 mg tliet darbiet kuljum għal 3-5 ġimgħat.
English: Nicergoline was also given to 17 patients with migraines for prevention of attacks (Prusinski, Wiad.Lek, 1984).
Maltese: Nicergoline ngħata wkoll lil 17-il pazjent b'emigranji għall-prevenzjoni talattakki (Prusinski, Wiad.Lek, 1984).
English: Nevertheless, the MAH also provided an analysis regarding all spontaneous reports for the last 40 years (n=390, including 205 medically-confirmed cases).
Maltese: Madankollu, il-MAH ipprovda wkoll analiżi dwar ir-rapporti spontanji kollha għall-aħħar 40 sena (n=390, fosthom 205 każijiet medikament ikkonfermati).
English: The MAHs considers that the most comprehensive review of nicergoline efficacy was completed in a meta-analysis performed in 2008 by Winblad et al.
Maltese: Il-MAHs iħossu li l-aktar reviżjoni komprensiva tal-effikaċja ta' nicergoline saret f'meta-analiżi mwettqa fl-2008 minn Winblad et al.
English: Four cases of fibrotic events were excluded from the analysis.
Maltese: Erba' każijiet ta' avvenimenti fibrotiċi kienu esklużi mill-analiżi.
English: The CHMP noted that an under-notification of the adverse events can also be suspected given that:
Maltese: Is-CHMP innota li jista' jkun hemm ukoll suspett ta' nuqqas ta' rapportar ta' avvenimenti avversi minħabba li:
English: Results show statistically significant difference between nicergoline and placebo in favour of nicergoline.
Maltese: Ir-riżultati juru differenza statistikament sinifikanti bejn nicergoline u plaċebo favur nicergoline.
English: The CHMP has considered the totality of the available data on the safety and efficacy of nicergoline.
Maltese: Is-CHMP ikkunsidra t-totalità tad-dejta disponibbli dwar is-sigurtà u l-effikaċja ta' nicergoline.
English: Indeed, this publication described the metaanalysis of 13 double-blind, placebo-controlled, randomised studies performed by the Cochrane Collaboration in 2001.
Maltese: Fil-fatt, din il-pubblikazzjoni ddeskriviet il-meta-analiżi ta' 13-il studju aleatorju, bi blindaġġ doppju, ikkontrollati bi plaċebo, li saru mill-Cochrane Collaboration fl-2001.
English: Overall, the study designs were adequate (randomised, double-blind, placebo-controlled), diagnoses were established according classification criteria at the time of the studies, primary efficacy scales were defined a priori (MMSE, SCAG, ADAS-Cog).
Maltese: B'mod ġenerali, id-disinji tal-istudji kienu adegwati (aleatorji, bi blindaġġ doppju, ikkontrollati bi plaċebo), id-dijanjosi kienu stabbiliti skont il-kriterji ta' klassifikazzjoni fil-ħin tal-istudji, l-iskali taleffikaċja primarja kienu definit a priori (MMSE, SCAG, ADAS-Cog).
English: Nicergoline is a semisynthetic ergoline derivative that seems to have an action: (i) as an α1adrenoceptor antagonist, it induces vasodilation and increases arterial blood flow; (ii) it enhances cholinergic and catecholaminergic neurotransmitter function; (iii) it inhibits platelet aggregation; (iv) it promotes metabolic activity, resulting in increased utilization of oxygen and glucose; and (v) it has neurotrophic and antioxidant properties.
Maltese: (i) bħala antagonist tal-adrenoċettur α1, jinduċi l-vażodilazzjoni u jżid il-fluss tad-demm arterjali; (ii) itejjeb il-funzjoni tannewrotrasmettituri kolinerġiċi u katekolaminerġiċi; (iii) jinibixxi l-aggregazzjoni tal-plejtlits; (iv) jippromwovi l-attività metabolika, li twassal għal użu akbar tal-ossiġnu u l-glukożju; u (v) għandu karatteristiċi newrotrofiċi u antiossidanti.
English: For the indications “ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin” and “acute retinopathies of vascular origin” the CHMP noted that positive clinical results (in particular regarding the progression of visual acuity) were described mainly in one open long-term study in the context of an ambulatory ophthalmological practice that involved 213 patients with heterogeneous pathologies (e.g. retina degeneration, inflammatory diseases of the retina and of the optic nerve, venous and arterial vessels occlusions, glaucoma, etc) (Hasslinger, 1986).
Maltese: Għall-indikazzjonijiet “kura anċillari ta' tnaqqis fl-akutezza viżwali u disturbi fil-vista preżumibbilment ta' oriġini vaskulari” u “retinopatiji akuti ta' oriġini vaskulari” is-CHMP innota li r-riżultati kliniċi pożittivi (b'mod partikolari fir-rigward tal-progressjoni tal-akutezza viżwali) kienu deskritti prinċipalment fi studju miftuħ fit-tul fil-kuntest ta' prattika oftalmoloġika ambulatorja li fih ħadu sehem 213-il pazjent b'patoloġiji eteroġenji (eż. deġenerazzjoni tar-retina, mard infjammatorju tar-retina u tal-nerv ottiku, sadd tal-vini u l-arterji, glawkoma, eċċ) (Hasslinger, 1986).
English: The main localisation of fibrosis is preferentially pulmonary area and also retroperitoneal and cardiac area.
Maltese: Il-lokalizzazzjoni prinċipali talfibrożi hija b'mod preferenzjali iż-żona pulmonari u wkoll iż-żona retroperitoneali u kardijaka.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for ergot derivatives containing medicinal products.
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal prodotti mediċinali li fihom derivati tal-ergotina fl-indikazzjonijiet ikkonċernati.
English: The Committee concluded that the benefit-risk balance of nicergoline containing products is not favourable pursuant to Article 116 of Directive 2001/83/EC for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia), for ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II), for ancillary treatment of Raynaud's syndrome, for ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin, for acute retinopathies of vascular origin and for prophylaxis of migraine headache.
Maltese: Il-Kumitat ikkonkluda li skont l-Artikolu 116 tad-Direttiva 2001/83/KE, il-bilanċ bejn il-benefiċċju u rriskju tal-prodotti li fihom nicergoline mhuwiex favorevoli għall-kura sintomatika ta' indeboliment konjittiv u newrosensorjali patoloġiku kroniku fl-anzjani (minbarra l-marda ta' Alzheimer u tipi oħra ta' dimenzja), għall-kura anċillari ta' klawdikazzjoni intermittenti f'mard okklużiv sintomatiku tal-arterji periferali (PAOD ta' Stadju II), għall-kura anċillari tas-sindromu ta' Raynaud, għall-kura anċillari ta' tnaqqis fl-akutezza viżwali u disturbi fil-vista preżumibbilment ta' oriġini vaskulari, għal retinopatiji akuti ta' oriġini vaskulari u għall-profilassi tal-uġigħ ta' ras tal-emigranja.
English: On admission to the study, patients were suffering from 1-3 attacks per week.
Maltese: Meta daħlu fl-istudju, il-pazjenti kienu qed ibatu minn 1-3 attakki fil-ġimgħa.
English: Fourty (40) patients with migraine were assessed in an open clinical study that became available after the initial marketing authorisation was granted (Prusinski, Wiad.Lek, 1984).
Maltese: Erbgħin (40) pazjent bl-emigranja kienu vvalutati fi studju kliniku miftuħ li sar disponibbli wara li ngħatat l-awtorizzazzjoni inizjali għat-tqegħid fis-suq (Prusinski, Wiad.Lek, 1984).
English: The MAHs also submitted their own overviews and critical summaries of all spontaneous reports of fibrotic reactions (cardiac with or without pulmonary arterial hypertension, pulmonary, pleural, peritoneal, retroperitoneal, etc) and ergotism with their ergot derivatives-containing medicinal products.
Maltese: Il-MAHs ippreżentaw ukoll il-perspettivi u ssommarji kritiċi tagħhom tar-rapporti spontanji kollha ta' reazzjonijiet fibrotiċi (kardijaċi bi jew mingħajr pressjoni għolja fl-arterji pulmonari, pulmonari, plewrali, peritoneali, retroperitoneali, eċċ) u ergotiżmu bil-prodotti mediċinali tagħhom li fihom derivati tal-ergotina.
English: − Is not favourable for acute retinopathies of vascular origin.
Maltese: − Mhuwiex favorevoli għal retinopatiji akuti ta' oriġini vaskulari.
English: The MAH further provided information on six clinical comparative studies in senile cerebral insufficiency and a short description of a non-comparative study and three observational studies in support of the efficacy of nicergoline in a specific indication “symptomatic treatment of mild cognitive impairment of vascular origin in the elderly”.
Maltese: Il-MAH ipprovda wkoll informazzjoni dwar sitt studji kliniċi komparattivi dwar l-insuffiċjenza ċerebrali senili u deskrizzjoni qasira ta' studju mhux komparattiv u tliet studji ta' osservazzjoni b'appoġġ għalleffikaċja ta' nicergoline f'indikazzjoni speċifika “kura sintomatika ta' indeboliment konjittiv ħafif ta' oriġini vaskulari fl-anzjani”.
English: − Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II).
Maltese: − Kura anċillari ta' klawdikazzjoni intermittenti f'mard okklużiv sintomatiku tal-arterji periferali (PAOD ta' Stadju II).
English: − Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Maltese: − Kura sintomatika ta' indeboliment konjittiv u newrosensorjali patoloġiku kroniku fl-anzjani (minbarra l-marda ta' Alzheimer u tipi oħra ta' dimenzja).
English: − Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin.
Maltese: − Kura anċillari ta' tnaqqis fl-akutezza viżwali u disturbi fil-vista preżumibbilment ta' oriġini vaskulari.
English: The majority of them had been previously treated with various anti-migraine drugs like dihydroergotamine, pizotifen and propranolol with unsatisfactory effects.
Maltese: Il-maġġoranza tagħhom kienu rċevew kura preċedenti b'diversi mediċini kontra l-emigranja bħal dihydroergotamine, pizotifen u propranolol b'effetti li ma kinux sodisfaċenti.