FrancophonIA/ELRC3.0 huggingface dataset:
English: In subchronic continuous intrathecal infusion studies in rats and dogs, behavioural effects were seen at doses ≥ 8-fold the maximum recommended clinical intrathecal infusion dose of 21.6 μg/day (on a mg/kg basis).
Maltese: Fi studji dwar l-infużjoni sotto-kronika kontinwa għal ġot-teka fil-firien u klieb, l-effetti fuq l-imġiba kienu osservati f'dożi ta' ≥ 8 darbiet iktar mill-massimu rakkomandat tad-doża ta' l-infużjoni klinika għal ġot-teka ta' 21.6 μg/kuljum (fuq bażi ta' mg/kg).
English: The majority had spinal pain (n = 134), especially failed back surgery (n = 110); a lower proportion had neuropathy (n = 36).
Maltese: (n = 134), speċjalment operazzjoni fid-dahar li ma rnexxietx (n = 110); proporzjon iktar baxx kellhom newropatija (n = 36).
English: Decreased appetite, anxiety or worsened anxiety, hallucinations, inability to fall or stay asleep, agitation, disorientation, depression or worsened depression, nervousness, mood swings, mental status changes (thinking abnormal, confusion), paranoia, irritability, worsened confusion, difficulty with learning, memory or thinking, reflexes absent or impaired, problems expressing or understanding words, slurred speech, difficulty with speech or loss of ability to speak, sluggishness, balance or coordination impaired, burning sensation, increased abnormal sensation, reduced level of consciousness (unresponsive or almost unconscious), sedation, difficulty in concentrating, problems with the sense of smell, odd or no sense of taste, shaking, pins and needles, double vision, visual disturbance, intolerance to light, tinnitus (ringing in the ears), dizziness or spinning sensation, lightheadedness or dizziness when standing, low blood pressure, shortness of breath, dry mouth, abdominal pain, worsened nausea, diarrhoea, constipation, sweating, itching, muscle weakness, muscle spasms, muscle cramp, muscle or joint pain, difficult or painful urination, difficulty starting or controlling urination, feeling jittery, falling, pain or pain exacerbated, fatigue, feeling cold, swelling of the face, legs or feet, chest pain, blood chemistry changes, mental impairment and weight decreased.
Maltese: Nuqqas t'aptit, ansjetà jew ansjetà li tmur għall-agħar, alluċinazzjonijiet, ma tkunx tista' torqod jew tkompli torqod, aġitazzjoni, diżorjentament, depressjoni jew depressjoni li tmur għall-agħar, nervożità, tibdil fil-burdata, tibdil fl-istat mentali (taħseb b'mod anormali, konfużjoni), paranojja, irritabilità, konfużjoni li tmur għall-agħar, diffikultà biex titgħallem, fil-memorja jew biex taħseb, assenza jew indeboliment ta' riflessi, problemi biex tesprimi jew tifhem il-kliem, diskors li ma jiftiehemx, diffikultà biex titkellem jew titlef il-ħila li titkellem, indolenza, indeboliment fil-bilanċ jew filkoordinazzjoni, sensazzjoni ta' ħruq, żieda f'sensazzjonijiet mhux normali, livell imnaqqas ta' koxjenza (ma jkollok rispons jew kważi mitluf minn sensik), sedazzjoni, diffikultà biex tikkonċentra, problemi fis-sens tat-togħma, ittiegħem b'mod stramb jew l-ebda sens ta' togħma, rogħda, sensazzjoni bħal qisu xi ħadd qed iniggżek bil-labar, tara doppju, disturbi tal-vista, intolleranza għad-dawl, żanżin fil-widnejn (tisfir fil-widnejn), sturdament jew sensazzjoni ta' tidwir, sturdament jew tistordi meta tkun bilwieqfa, pressjoni tad-demm baxxa, qtugħ ta' nifs, ħalq xott, uġigħ addominali, tqallih li jmur għall-agħar, dijarea, stitikezza, għaraq, ħakk, dgħjufija fil-muskoli, spażmi tal-muskoli, bugħawwieġ fil-muskoli, uġigħ fil-muskoli jew fil-gogi, diffikultà jew uġigħ meta tagħmel l-awrina, diffikultà biex tibda jew tikkontrolla meta tagħmel l-awrina, tħossok nervuż/a, taqa', uġigħ jew uġigħ li jiħrax, għeja kbira, tħoss il-bard, nefħa tal-wiċċ, riġlejn jew saqajn, uġigħ fis-sider, tibdil fil-kimika tad-demm, indeboliment mentali u tnaqqis fil-piż.
English: Study 301 (n = 220) was of longer duration (21 days), involved more cautious up-titration and lower doses of IT ziconotide, and enrolled the most refractory population of patients studied in the three studies.
Maltese: Studju 301 (n = 220) kien ta' żmien itwal (21 jum), involva titrazzjoni ‘l fuq b'iktar kawtela u dożi iktar baxxi ta' ziconotide IT, u rreġistra l-iktar popolazzjoni refrattarja ta' pazjenti studjati fit-tliet studji.
English: Unless otherwise noted the table shows the incidence rates of adverse reactions reported in the intrathecal clinical trials with ziconotide (short- and long-term exposure).
Maltese: Ħlief jekk mhuwiex innutat mod ieħor, it-tabella turi r-rati ta' inċidenza ta' reazzjonijiet avversi rrappurtati fil-provi kliniċi ta' ġot-teka b'ziconotide (espożizzjoni qasira u fit-tul).
English: The recommended starting dose is no more than 2.4 micrograms per day.
Maltese: Id-doża tal-bidu rakkomandata hi ta' mhux iktar minn 2.4 mikrogrammi kuljum.
English: Each vial contains 20 ml solution for infusion.
Maltese: Kull kunjett fih 20 ml ta' soluzzjoni għall-infużjoni.
English: These studies were of short duration, 5 and 6 days respectively, and used a more rapid dose escalation and higher doses than recommended in Section 4.2.
Maltese: Dawn l-istudji damu ftit, 5 u 6 ijiem rispettivament, u użaw żieda fid-doża iktar mgħaġġla, u dożi ogħla minn dawk rakkomandati f'Sezzjoni 4.2.
English: CE marked pumps equivalent to the Synchromed and CADD-Micro pump should be used to deliver Prialt.
Maltese: Pompi mmarkati CE, li huma ekwivalenti għal Synchromed u CADD-Micro pump, għandhom jintużaw biex ifornu Prialt.
English: CE marked pumps equivalent to the Synchromed and CADD-Micro pump should be used to deliver ziconotide.
Maltese: Pompi mmarkati CE, li huma ekwivalenti għal Synchromed u CADD-Micro pump, għandhom jintużaw biex ifornu ziconotide.
English: However, low plasma ziconotide concentrations, metabolism by ubiquitous peptidases and relatively low plasma protein binding (see section 5.2) make metabolic-based interactions or plasma protein displacement type interactions between ziconotide and other medicinal products unlikely.
Maltese: Madankollu, konċentrazzjonijiet baxxi ta' ziconotide fil-plażma, metaboliżmu minn peptidases li huma preżenti kullimkien u twaħħil relattivament baxx tal-proteina fil-plażma (ara sezzjoni 5.2) jagħmlu l-interazzjonijiet ibbażati fuq il-metaboliżmu jew interazzjonijiet tat-tip ta' l-ispostament talproteina fil-plażma bejn ziconotide u prodotti mediċinali oħrajn, mhux mistennija.
English: It is unlikely that the degradation products of ziconotide will have significant biological activity, as peptides consisting of the individual peptide loop structures have been found to have binding affinities for N-type voltage sensitive calcium channels that are several orders of magnitude lower than that of the parent (ziconotide) compound.
Maltese: Mhux mistenni li l-prodotti tad-degradazzjoni ta' ziconotide ser ikollhom attività bijoloġika sinifikanti, għax instab li l-peptides li jikkonsistu minn strutturi loop peptide individwali, għandhom affinitajiet li jwaħħlu għal N-type voltage sensitive calcium channels, li huma ħafna drabi iktar baxxi minn dawk tal-kompost prinċipali (ziconotide).
English: Mean VASPI score at end of initial titration in mm (SD) % improvement in VASPI score at end of initial titration (SD) Respondera n (%)
Maltese: Medja tal-punteġġ VASPI fittmiem tat-titrazzjoni inizjali f'mm (SD) % titjib fil-punteġġ VASPI fit-tmiem tat-titrazzjoni inizjali f'mm (SD) Pazjenti li rrispondewa n (%)
English: Musculoskeletal and connective tissue disorders pain in limb, myalgia, muscle spasms, muscle cramp, muscle weakness, arthralgia, peripheral swelling rhabdomyolysis, myositis, back pain, muscle twitching, neck pain
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi uġigħ fir-riġlejn jew fiddirgħajn, mijalġja, spażmi tal-muskoli, bugħawwieġ fil-muskoli, dgħufija filmuskoli, artralġja, nefħa periferali rabdomijolosi, mijosite, uġigħ fiddahar, kontrazzjonijiet talmuskoli, uġigħ flgħonq
English: Following passage into the systemic circulation, ziconotide is expected to be primarily susceptible to proteolytic cleavage by various ubiquitous peptidases/proteases present in most organs (e.g., kidney, liver, lung, muscle, etc.), and thus degraded to peptide fragments and its individual constituent free amino acids.
Maltese: Wara li jgħaddi għal ġoċċirkolazzjoni sistemika, ziconotide hu mistenni li jkun primarjament suxxettibbli għal cleavage proteolitiku minn peptidases/proteases varji li huma preżenti kullimkien fil-biċċa l-kbira ta' l-organi (eż., kliewi, fwied, pulmun, muskoli, eċċ.), u għaldaqstant iddegrada għal frak tal-peptides u l-amino acids liberi kostitwenti individwali tiegħu.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 25 μg ziconotide (as acetate).
Maltese: U KWANTITATTIVA 1 ml soluzzjoni fih 25 μg ta' ziconotide (bħala acetate).
English: - The other ingredients (excipients) are methionine, sodium chloride, water for injections,
Maltese: - Is-sustanzi l-oħra (eċċipjenti) huma methionine, sodium chloride, ilma għall-injezzjonijiet,
English: Marketing Authorisation Holder: RIEMSER Pharma GmbH An der Wiek 7
Maltese: Detentur tal-Awtorizazzjoni għat-Tqegħid fis-Suq: RIEMSER Pharma GmbH
English: - Each 20 ml vial contains 500 micrograms ziconotide (as acetate).
Maltese: - Kull kunjett ta' 20 ml fih 500 mikrogramma ta' ziconotide (bħala acetate).
English: Each 20 ml vial contains 500 μg ziconotide (as acetate).
Maltese: Kull kunjett ta' 20 ml fih 500 μg ta' ziconotide (bħala acetate).
English: The cognitive effects of ziconotide are typically reversible within 1 - 4 weeks after discontinuation of the medicinal product, but may persist in some cases.
Maltese: L-effetti konoxxittivi ta' ziconotide huma tipikament riversibbli fi żmien 1 - 4 ġimgħat wara t-twaqqif tal-prodott mediċinali, iżda jistgħu jippersistu f'xi każijiet.
English: Caution should be exercised when ziconotide is administered to patients who are receiving systemic chemotherapy (see section 4.4).
Maltese: Għandha tingħata attenzjoni meta ziconotide jingħata lil pazjenti li jkunu qegħdin jirċievu kimoterapija sistemika (ara sezzjoni 4.4).
English: NAME OF THE MEDICINAL PRODUCT Prialt 25 μg/ml solution for infusion ziconotide
Maltese: Prialt 25 μg/ml soluzzjoni għall-infużjoni ziconotide
English: Mean VASPI score at baseline in mm (SD) Mean VASPI score at end of initial titration in mm (SD) % improvement in VASPI score at end of initial titration (SD)
Maltese: Medja tal-punteġġ VASPI fittmiem tat-titrazzjoni inizjali f'mm (SD) % titjib fil-punteġġ VASPI fittmiem tat-titrazzjoni inizjali (SD)
English: Prior to initiation of therapy, an internal pump must be rinsed three times with 2 ml of Prialt at 25 μg/ml.
Maltese: Qabel il-bidu tat-terapija, pompa interna trid titlaħlaħ tliet darbiet b'2 ml ta' Prialt f'25 μg/ml.
English: NAME OF THE MEDICINAL PRODUCT Prialt 100 micrograms/ml solution for infusion ziconotide
Maltese: Prialt 100 mikrogramma/ml soluzzjoni għall-infużjoni ziconotide
English: In intravenous infusion studies, healthy male volunteers received ziconotide at doses of up to 70,000 μg/day or 3,200 times the maximum recommended daily intrathecal infusion dose.
Maltese: Fi studji dwar l-infużjoni fil-vina, voluntiera rġiel b'saħħithom irċivew ziconotide f'dożi sa 70,000 μg/kuljum jew 3,200 darba tal-massimu rakkomandat tad-doża ta' infużjoni ta' kuljum għal ġot-teka.
English: Ziconotide appears to distribute mainly within the CSF until transferred to the systemic circulation.
Maltese: Ziconotide jidher li jitqassam primarjament ġos-CSF sakemm ikun ittrasferit fiċ-ċirkolazzjoni sistemika.
English: Adding IT ziconotide to stable doses of IT morphine (see section 5.1), is possible but requires special attention, as a high rate of neuropsychiatric adverse reactions (confusion/thinking abnormal, paranoid reactions and hallucinations, and abnormal gait), some of them serious, was observed in Study 202 despite a low dose of ziconotide.
Maltese: Li żżid ziconotide IT ma' dożi stabbli ta' morphine IT (ara sezzjoni 5.1), hu possibbli, iżda dan jeħtieġ attenzjoni speċjali, għax rata għolja ta' reazzjonijiet newropsikjatriċi avversi (konfużjoni/ħsibijiet anormali, reazzjonijiet paranojde u alluċinazzjonijiet, u mixi b'mod anormali), li xi wħud minnhom kienu serji, kienu osservati fi Studju 202 minkejja doża baxxa ta' ziconotide.
English: Mean VASPI score at baseline in mm (SD)
Maltese: Medja tal-punteġġ VASPI fillinja bażi f'mm (SD)
English: In a study on male and female fertility in rats no effects in males while reductions in corpora lutea; implantation sites and number of live embryos were observed in females (see section 5.3).
Maltese: Fi studju dwar il-fertilità f'firien irġiel u nisa, ma kien hemm l-ebda effetti fil-firien irġiel filwaqt li tnaqqis fil-corpora lutea, siti tal-impjantazzjoni u n-numru ta' embriji ħajjin kienu osservati fil-firien nisa (ara sezzjoni 5.3).
English: NAME OF THE MEDICINAL PRODUCT Prialt 25 micrograms/ml solution for infusion ziconotide
Maltese: Prialt 25 mikrogramma/ml soluzzjoni għall-infużjoni Ziconotide
English: Psychiatric disorders confusional state anxiety, auditory hallucination, insomnia, agitation, disorientation, hallucination, visual hallucination, depression, paranoia, irritability, depression aggravated, nervousness, affect lability, mental status changes, anxiety aggravated, confusion aggravated delirium, psychotic disorder, suicidal ideation, suicide attempt, thought blocking, abnormal dreams, aggressiveness
Maltese: Disturbi psikjatriċi stat ta' konfużjoni ansjetà, alluċinazzjoni tassmigħ, nuqqas ta' rqad, aġitazzjoni, diżorjentament, alluċinazzjoni, alluċinazzjoni viżwali, depressjoni, paranojja, irritabilità, depressjoni aggravata, nervożità, daħk/tbissim/biki patoloġiku, tibdil fl-istat mentali, ansjetà aggravata, konfużjoni aggravata delirju, disturb psikotiku, formazzjoni ta' ħsieb biex jitwettaq suwiċidju, attentat ta' suwiċidju, imblukkar tal-ħsibijiet, ħolm anormali, aggressività
English: Mean Median Range aResponders were defined as those patients who 1) experienced a ≥ 30% drop in VASPI score compared to baseline; 2) had stable or decreased concomitant opioid analgesics; and 3) had opiate type unchanged from preinfusion if receiving opiates.
Maltese: Medda aDawk li rrispondew kienu definiti bħala dawk il-pazjenti li 1) kellhom tnaqqis ta' ≥ 30% fil-punteġġ VASPI meta mqabbel mal-linja bażi; 2) kellhom analġeżiċi opioid fl-istess ħin stabbli jew imnaqqsa; u 3) kellhom it-tip ta' opiate mhux mibdul minn dak ta' qabel l-infużjoni, jekk kienu qed jirċievu lopiates.
English: Gastrointestinal disorders nausea, vomiting diarrhoea, dry mouth, constipation, nausea aggravated, upper abdominal pain dyspepsia
Maltese: inkoerenza, tintilef minn sensik, koma, sturdament, konvulżjonijiet, inċident ċerebrovaskulari,
English: If discontinuing opiates when initiating ziconotide therapy, opiate withdrawal should be gradual.
Maltese: Jekk jitwaqqfu l-opiates meta tibda tterapija b'ziconotide, it-twaqqif ta' l-opiate għandu jkun gradwali.
English: Each ml contains 100 micrograms ziconotide (as acetate).
Maltese: Kull 1 ml fih 100 mikrogramma ta' ziconotide (bħala acetate).
English: Approximately 75% of patients who respond satisfactorily to treatment require a dose of ≤ 9.6 μg/day.
Maltese: Madwar 75% tal-pazjenti li jirrispondu b'mod sodisfaċenti għall-kura jeħtieġu doża ta' ≤ 9.6 μg/kuljum.
English: NAME OF THE MEDICINAL PRODUCT Prialt 25 micrograms/ml solution for infusion
Maltese: Prialt 25 mikrogramma/ml soluzzjoni għall-infużjoni
English: Each 1 ml vial contains 100 μg ziconotide (as acetate).
Maltese: Kull kunjett ta' 1 ml fih 100 μg ta' ziconotide (bħala acetate).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Maltese: Jekk ma jintużax immedjatament, iż-żmien tal-ħażna waqt l-użu u lkundizzjonijiet ta' qabel l-użu huma r-responsabbiltà ta' l-utent, u normalment ma jkunux itwal minn 24 siegħa f'temperatura ta' 2°C - 8°C, ħlief jekk dilwizzjoni ma tkunx saret f'kundizzjonijiet asettiċi kkontrollati u vverifikati.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 100 μg ziconotide (as acetate).
Maltese: U KWANTITATTIVA 1 ml soluzzjoni fih 100 μg ta' ziconotide (bħala acetate).
English: As the risk of meningitis secondary to prolonged catheterisation of the intrathecal space is greater with an external catheter infusion system, internal systems are recommended to administer ziconotide for prolonged periods (see section 4.4).
Maltese: Billi r-riskju ta' meninġite sekondarja għal kateterizzazzjoni fit-tul tal-ispazju ġot-teka hu akbar b'sistema tal-infużjoni b'kateter estern, sistemi interni huma rakkomandati biex jingħata ziconotide għal perjodi twal (ara sezzjoni 4.4).
English: Nervous system adverse reactions, particularly dizziness, nausea and abnormal gait appear to be correlated with CSF exposure, though a definitive relationship has not been established.
Maltese: Madankollu, ilpotenzjal għal reazzjonijiet allerġiċi severi ma jistax jiġi eskluż u rapporti spontanji ta' reazzjonijiet anafilattiċi ġew riċevuti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/302/004 - 20 ml solution for infusion
Maltese: EU/1/04/302/004 - 20 ml soluzzjoni għall-infużjoni
English: However, in clinical trials it has been observed that patients who tolerate doses of 21.6 μg/day following slow titration over a 3 to 4-week period, generally tolerate higher doses up to 48.0 μg/day.
Maltese: Madankollu, fi provi kliniċi, kien osservat li l-pazjenti li jittolleraw dożi ta' 21.6 μg/kuljum wara titrazzjoni bil-mod fuq perijodu ta' minn 3 sa 4 ġimgħat, ġeneralment jittolleraw dożi ogħla sa 48.0 μg/kuljum.
English: NAME OF THE MEDICINAL PRODUCT Prialt 100 micrograms/ml solution for infusion
Maltese: Prialt 100 mikrogramma/ml soluzzjoni għall-infużjoni
English: Each vial contains 200 micrograms ziconotide (as acetate).
Maltese: Kull kunjett fih 200 mikrogramma ta' ziconotide (bħala acetate).
English: Ziconotide is contraindicated in combination with IT chemotherapy (see section 4.3).
Maltese: Il-pazjenti u t-tobba jridu jkunu viġilanti għal sintomi u sinjali tipiċi ta' meninġite (ara sezzjoni 4.4).
English: Alternative dosing regimens including initiation of dosing with lower doses of ziconotide and bolus administration have been explored in a limited number of studies available in the literature.
Maltese: Korsijiet ta' dożaġġ alternattivi li jinkludu l-bidu tad-dożaġġ b'dożi iktar baxxi ta' ziconotide u l-għoti bolus ġew esplorati f'numru limitat ta' studji disponibbli fil-letteratura.
English: Infection of the blood stream, delirium (feeling of mental confusion), psychotic disorder (abnormal thinking and perceptions), thought disorders, abnormal dreams, incoherence (inability to make sense), loss of consciousness, stupor (unresponsive/difficult to arouse), stroke, encephalopathy (brain disorder), aggressiveness, abnormal heart rhythm, difficulty breathing, indigestion, rash, muscle inflammation, back pain, muscle twitching, neck pain, acute kidney failure, abnormal heart trace measurements (ECG), raised body temperature, difficulty walking.
Maltese: Mhux komuni (jistgħu jaffettwaw minn 1 sa 10 utenti minn kull 1,000) Infezzjoni tal-fluss tad-demm, delirju (sensazzjoni ta' konfużjoni mentali), disturbi psikotiċi (ħsibijiet u perċezzjonijiet anormali), disturbi fil-ħsibijiet, ħolm anormali, inkoerenza (ma tkunx kapaċi tagħmel sens), tintilef minn sensik, sturdament (ma tirrispondix/diffiċli biex tħoss l-emozzjonijiet), puplesija, enċefalopatija (disturb tal-moħħ), aggressività, rittmu anormali tal-qalb, diffikultà biex tieħu n-nifs, indiġestjoni, raxx, infjammazzjoni tal-muskoli, uġigħ fid-dahar, kontrazzjonijiet tal-muskoli, uġigħ flgħonq, insuffiċjenza akuta tal-kliewi, kejl anormali ta' intraċċar tal-qalb (ECG), temperatura tal-ġisem għolja, diffikultà biex timxi.
English: EXP
Maltese: CSF
English: Renal and urinary disorders urinary retention, urinary hesitation, dysuria, urinary incontinence acute renal failure
Maltese: Disturbi fil-kliewi u fissistema urinarja żamma tal-awrina, eżitazzjoni urinarja, uġigħ u diffikultà biex tagħmel lawrina, inkontinenza flawrina insuffiċjenza akuta tal-kliewi
English: Low plasma exposure occurs during IT infusion due to the low recommended IT infusion rates and relatively rapid plasma clearance (see section 5.2).
Maltese: Espożizzjoni baxxa tal-plażma sseħħ matul l-infużjoni IT minħabba r-rati baxxi rakkomandati tal-infużjoni IT, u minħabba t-tneħħija relattivament mgħaġġla tal-plażma (ara sezzjoni 5.2).
English: The generated free amino acids are expected to be taken up by cellular carrier systems and either subjected to normal intermediary metabolism or used as substrates for constitutive biosynthetic processes.
Maltese: L-amino acids liberi ġġenerati huma mistennija li jittieħdu minn sistemi ċellulari li jġorru u jew ikunu suġġetti għal metaboliżmu intermedjarju normali, jew jintużaw bħala sotto-strati għal proċessi bijosintetiċi kostituttivi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/302/001 - 1 ml solution for infusion.
Maltese: EU/1/04/302/001 - 1 ml soluzzjoni għall-infużjoni.
English: Ziconotide is indicated for the treatment of severe, chronic pain in adults who require intrathecal (IT) analgesia.
Maltese: Ziconotide hu indikat għall-kura ta' uġigħ sever kroniku f'adulti li jeħtieġu analġeżja għal ġot-teka (intrathecal - IT).
English: Each vial contains 100 micrograms ziconotide (as acetate).
Maltese: Kull kunjett fih 100 mikrogramma ta' ziconotide (bħala acetate).
English: No adverse effects on female reproduction and post-natal development in rats were seen at systemic exposures up to 2,300 times human exposures at the maximum recommended intrathecal dose.
Maltese: Ma kienu osservati l-ebda effetti avversi fuq ir-riproduzzjoni tan-nisa u fuq l-iżvilupp ta' wara t-twelid filfirien, f'espożizzjonijiet sistemiċi sa 2,300 darba ta' l-espożizzjoni fil-bniedem fid-doża għal ġot-teka massima rakkomandata.
English: Discontinuation of ziconotide should be considered in the event of progressive or significant elevation of creatine phosphokinase in association with clinical features of myopathy or rhabdomyolysis (see section 4.4).
Maltese: Hu rakkomandat li l-pazjenti ssirilhom evalwazzjoni newropsikjatrika qabel u wara li jibdew ziconotide ġot-teka (ara sezzjoni 4.4).
English: Mean
Maltese: ISEM
English: General disorders and administration site conditions gait abnormal, asthenia fatigue, pyrexia, lethargy, oedema peripheral, rigors, fall, chest pain, feeling cold, pain, feeling jittery, pain exacerbated difficulty in walking
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata mixi anormali, astenja għeja kbira, deni, letarġija, edema periferali, tertir, waqgħat, uġigħ fid-sider, tħoss il-bard, uġigħ, tħossok nervuż, aggravament taluġigħ diffikultà biex timxi
English: The efficacy of IT ziconotide was apparent in all groups.
Maltese: L-effikaċja ta' ziconotide IT kienet apparenti fil-gruppi kollha.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Prialt 100 μg/ml infusion
Maltese: U MNEJN GĦANDU JINGHATA Prialt 100 μg/ml/infużjoni
English: Ziconotide is a synthetic analogue of a ω-conopeptide, MVIIA, found in the venom of the Conus magus marine snail.
Maltese: Ilbiċċa l-kbira tar-reazzjonijiet avversi kienu minn ħfief sa moderati fis-severità u fiequ maż-żmien.
English: Vascular disorders orthostatic hypot ension, hypotension
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI
English: Elevations in creatine kinase, which are usually asymptomatic, are common amongst patients on intrathecal ziconotide.
Maltese: Elevazzjonijiet fil-creatine kinase, li huma normalment asintomatiċi, huma komuni fost il-pazjenti li jingħataw ziconotide għal ġot-teka.
English: To limit the occurrence of serious adverse reactions, a maximum dose of 21.6 μg/day is recommended.
Maltese: Biex tillimita l-okkorrenza ta' reazzjonijiet avversi serji, doża massima ta' 21.6 μg/kuljum hi rakkomandata.
English: Marketing Authorisation Holder RIEMSER Pharma GmbH An der Wiek 7
Maltese: Detentur tal-Awtorizazzjoni għat-Tqegħid fis-Suq RIEMSER Pharma GmbH