FrancophonIA/ELRC3.0 huggingface dataset:
English: Denmark Omrix Biopharmaceuticals S.A., Chaussee de Waterloo 200, B-1640 Rhode-St-Genese Belgium
Maltese: Ir-Renju Unit Omrix Biopharmaceuticals S.A., Chaussee de Waterloo 200, B-1640
English: United Kingdom
Maltese: Franza
English: Thrombin: 800 IU/ml -1,200 IU/ml Calcium Chloride: 5.6 mg/ml - 6.2 mg/ml
Maltese: Fibrinoġen u Fibronektina: 40 mg/ml-60 mg/ml Tranexamic acid: 85 mg/ml-105 mg/ml Thrombin: 800 IU/ml-1200 IU/ml Klorur tal-Kalċju: 5.6 mg/ml-6.2 mg/ml
English: Tranexamic acid: 85 mg/ml -105 mg/ml
Maltese: 95mg/ml
English: Invented name Name
Maltese: Isem ivvintat Isem
English: CL = clearance; Vd = distribution volume; t½ = half life
Maltese: CL = tneħħija; Vd = distribuzzjoni tal-volum; t½ = half life
English: It is an N-type calcium channel blocker (NCCB).
Maltese: Hu N-type calcium channel blocker (NCCB).
English: Plasma 21
Maltese: Plażma 21
English: Date of latest renewal: 18 September 2014
Maltese: Data tal-aħħar tiġdid: 18 ta' Settembru, 2014
English: Respondera n (%)
Maltese: Pazjenti li rrispondewa n (%)
English: What Prialt contains - The active substance is ziconotide.
Maltese: X'fih Prialt - Is-sustanza attiva hi ziconotide.
English: 17493 Greifswald-Insel Riems Germany
Maltese: 17493 Greifswald-Insel Riems Il-Ġermanja
English: t½ (hr)
Maltese: t½ (sigħat)
English: 44b 17489 Greifswald Germany
Maltese: 44b 17489 Greifswald Il-Ġermanja
English: Depression of Central Nervous System (CNS)
Maltese: Dipressjoni tas-Sistema Nervuza Ċentrali (SNĊ)
English: The maximum dose is 21.6 micrograms/day.
Maltese: Id-doża massima hi ta' 21.6 mikrogramma/kuljum.
English: hydrochloric acid and sodium hydroxide.
Maltese: hydrochloric acid u sodium hydroxide.
English: SD - Standard Deviation.
Maltese: SD = Standard Deviation - Devjazzjoni Standard
English: In clinical trials, 88% of patients experienced adverse reactions.
Maltese: Fi provi kliniċi, 88% tal-pazjenti kellhom reazzjonijiet avversi tal-mediċina.
English: Respiratory, thoracic and mediastinal disorders dyspnoea respiratory distress
Maltese: Disturbi respiratorji, toraċiċi u medjastinali dispnea problemi respiratorji
English: Sodium chloride Water for injections Hydrochloric acid (pH adjuster) Sodium hydroxide (pH adjuster)
Maltese: Sodium chloride Ilma għall-injezzjonijiet Hydrochloric acid (pH adjuster) Sodium hydroxide (pH adjuster)
English: The most common adverse reactions reported in long-term clinical trials were dizziness (42%), nausea (30%), nystagmus (23%), confusional state (25%), gait abnormal (16%), memory impairment (13%), vision blurred (14%), headache (12%), asthenia (13%), vomiting (11%), and somnolence (10%).
Maltese: L-iktar reazzjonijiet avversi li kienu rrappurtati b'mod komuni fi studji kliniċi fit-tul kienu sturdament (42%), tqallih (30%), nystagmus (23%), stat ta' konfużjoni (25%), mixi anormali (16%), indeboliment tal-memorja (13%), vista mċajpra (14%), uġigħ ta' ras (12%), astenja (13%), rimettar (11%), u ngħas (10%).
English: Fluid matrix
Maltese: Matriċi talfluwidu
English: Metabolism and nutrition disorders appetite decreased, anorexia
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni nuqqas t'aptit, anoreksja
English: Infections and infestations sepsis, meningitis
Maltese: Infezzjonijiet u infestazzjonijiet sepsis, meninġite
English: Elevations in creatine kinase
Maltese: Żidiet fi creatine kinase
English: Efficacy results from study 95-001
Maltese: Riżultati ta' l-effikaċja minn studju 95-001
English: Efficacy results from study 96-002
Maltese: Riżultati ta' l-effikaċja minn studju 96-002
English: Elevations in creatine phosphokinase were usually asymptomatic.
Maltese: Żidiet fil-livelli ta' creatine phosphokinase kienu normalment asintomatiċi.
English: Mean ziconotide CL (0.38 ml/min) approximates adult human CSF turnover rate (0.3 - 0.4 ml/min).
Maltese: Il-medja ta' ziconotide CL (0.38 ml/min) toqrob ir-rata ta' l-ammont tas-CSF ta' bniedem adult (0.3 - 0.4 ml/min).
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali wrew tossiċità riproduttiva (ara 5.3).
English: Cardiac disorders atrial fibrillation
Maltese: Disturbi fil-qalb fibrillazzjoni atrijali
English: Eye disorders vision blurred diplopia, visual disturbance, photophobia
Maltese: Disturbi fl-għajnejn vista mċajpra diplopja, disturb tal-vista, fotofobija
English: Dose at end of titration (μg/hr)
Maltese: Doża fit-tmiem tat-titrazzjoni (μg/siegħa)
English: Elevations of creatine phosphokinase
Maltese: Żidiet fil-livelli ta' creatine phosphokinase
English: Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to <1/1,000) Very rare (<1/10,000)
Maltese: Rari (≥ 1/10,000 sa <1/1,000)
English: 500 micrograms/20ml
Maltese: 500 mikrogramma/20ml
English: Clinical studies 201 and 202 indicate that the combination of IT ziconotide and IT morphine may effectively reduce pain and decrease systemic opioid use over a sustained period of time for patients whose pain was inadequately controlled with their maximum tolerated dose of IT ziconotide (median 8.7 μg/day, mean 25.7 μg/day - study 201) or with IT morphine (study 202) alone.
Maltese: Studji kliniċi 201 u 202 jindikaw li l-kumbinazzjoni ta' ziconotide IT u morphine IT tista' tnaqqas luġigħ b'mod effettiv u tnaqqas l-użu ta' l-opioid sistemiku fuq perijodu sostnut ta' żmien għallpazjenti li l-uġigħ tagħhom ma kienx ikkontrollat b'mod adegwat, bid-doża massima ttollerata tagħhom ta' ziconotide IT (medjan 8.7 μg/kuljum, medja 25.7 μg/kuljum - studju 201) jew b'morphine IT (studju 202) waħdu.
English: Intrathecal use.
Maltese: Jintuża darba biss.
English: CSF and Plasma Pharmacokinetics of Ziconotide [mean ± SD (median)]
Maltese: Il-Farmakokinetiċi ta' CSF u tal-Plażma ta' Ziconotide [medja ± SD (medjan)]
English: 1 vial of 5 ml 5ml
Maltese: 1 kunjett ta' 5 ml 5ml
English: Placebo (n = 40)
Maltese: Plaċebo (n = 40)
English: Placebo (n = 108)
Maltese: Plaċebo (n = 108)
English: There is no evidence of the development of pharmacological tolerance to ziconotide in patients.
Maltese: M'hemm l-ebda evidenza ta' l-iżvilupp ta' tolleranza farmakoloġika għal ziconotide fil-pazjenti.
English: There was no indication of respiratory depression.
Maltese: Ma kien hemm l-ebda indikazzjoni ta' depressjoni respiratorja.
English: The infusion dose rate ranged from 0.03 - 912 μg/day, with a median final dose rate of 7.2 μg/day.
Maltese: Ir-rata ta' l-infużjoni varjat minn 0.03 - 912 μg/kuljum, b'medjan tar-rata tad-doża finali ta' 7.2 μg/kuljum.
English: 200 micrograms/2ml
Maltese: 200 mikrogramma/2ml
English: 100 micrograms /1ml
Maltese: 100 mikrogramma/1ml
English: Other medicines and Prialt
Maltese: Mediċini oħra u Prialt
English: Placebo (n = 86)
Maltese: Plaċebo (n = 86)
English: Clinical efficacy and safety There were three placebo-controlled clinical trials of IT ziconotide.
Maltese: Effikaċja klinika u sigurtà Kien hemm tliet provi kliniċi ta' ziconotide IT ikkontrollati bil-plaċebo.
English: The CSF pharmacokinetics of ziconotide have been studied following one-hour IT infusions of 1 - 10 μg of ziconotide in patients with chronic pain.
Maltese: Il-farmakokinetiċi tas-CSF ta' ziconotide kienu studjati wara infużjonijiet IT ta' siegħa ta' 1 - 10 μg ta' ziconotide f'pazjenti b'uġigħ kroniku.
English: 500 micrograms/5ml
Maltese: 500 mikrogramma/5ml
English: Stability has been demonstrated for 21 days at room temperature in the CADD-Micro pump.
Maltese: L-istabbiltà ntweriet għal 21 jum fit-temperatura tal-kamra filCADD-Micro pump.
English: • Rhabdomyolysis (may affect up to 1 in 100 people) - is breakdown of muscle fibres that can lead to kidney damage.
Maltese: • Rabdomijolosi (tista' taffettwa sa 1 minn kull 100 persuna) - hi t-tkissir tal-fibri tal-muskoli li jista' jwassal għal ħsara fil-kliewi.
English: Median ziconotide CSF volume of distribution (Vd: 99 ml) is between the spinal cord CSF volume (approximately 75 ml) and total CSF volume (approximately 130 ml).
Maltese: Il-medjan tal-volum tad-distribuzzjoni tas-CSF ta' ziconotide (Vd: 99 ml) hu bejn il-volum tas-CSF fis-sinsla (ta' madwar 75 ml) u l-volum totali tas-CSF (madwar 130 ml).
English: The safety and efficacy of ziconotide in children aged 0 to 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' ziconotide fit-tfal minn età ta' 0 sa 18-il sena ma ġewx determinati s'issa.
English: - Each 1 ml vial contains 100 micrograms; each 2 ml vial contains 200 micrograms; each 5 ml vial contains 500 micrograms.
Maltese: - Kull kunjett ta' 1 ml fih 100 mikrogramma; kull kunjett ta' 2 ml fih 200 mikrogramma; kull kunjett ta' 5 ml fih 500 mikrogramma.
English: Prialt was stable for 60 days at 37°C in the Synchromed pump previously exposed to the medicinal product.
Maltese: Prialt kien stabbli għal 60 jum f'temperatura ta' 37°C fil-pompa Synchromed li kienet esposta minn qabel għall-prodott mediċinali.
English: Combination studies with IT Morphine
Maltese: Studji kkumbinati bil-Morphine IT
English: The maximum intended intrathecal dose of ziconotide in clinical trials was 912 μg/day following upward titration over 7 days.
Maltese: Id-doża massima intenzjonata ta' ziconotide għal ġot-teka fi provi kliniċi kienet ta' 912 μg/kuljum wara żieda fit-titrazzjoni fuq perijodu ta' 7 ijiem.
English: PHARMACEUTICAL FORM Solution for infusion (infusion).
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-infużjoni (infużjoni).
English: 1 vial of 2 ml 2ml
Maltese: 1 kunjett ta' 2 ml 2ml
English: Ziconotide is a peptide consisting of 25 naturally-occurring amino acids of the L-configuration, and does not appear to be appreciably metabolised in the CSF.
Maltese: Ziconotide hu peptide li jikkonsisti minn 25 amino acids li jseħħu b'mod naturali li għandhom konfigurazzjoni L, u ma jidhirx li hu metabolat b'mod apprezzabbli fis-CSF.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 February 2005
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 21 ta' Frar, 2005
English: Patients should be titrated in dose increments of ≤ 2.4 μg/day, up to a maximum dose of 21.6 μg/day.
Maltese: Il-pazjenti għandhom ikunu ttitrati f'inkrementi tad-doża ta' ≤ 2.4 μg/kuljum, sa doża massima ta' 21.6 μg/kuljum.
English: The long-term consequences to neuronal function of continuous N-type calcium-channel block have not been demonstrated in experimental animals.
Maltese: Il-konsegwenzi fit-tul lill-funzjoni newronali ta' N-type calcium-channel block kontinwu ma ntwerewx f'esperimenti fuq l-annimali.
English: Combination with IT chemotherapy (see section 4.5).
Maltese: Użu flimkien ma' kimoterapija IT (ara sezzjoni 4.5).
English: Each vial contains 1, 2 or 5 ml solution for infusion.
Maltese: Kull kunjett fih 1, 2 jew 5 ml soluzzjoni għall-infużjoni.
English: Episodes of acute psychiatric disturbances, such as hallucinations, paranoid reactions, hostility, aggressiveness, delirium, psychosis and manic reactions have been reported in patients treated with ziconotide.
Maltese: Episodji ta' disturbi psikjatriċi akuti, bħal alluċinazzjonijiet, reazzjonijiet paranojde, ostilità, aggressività, delirju, psikosi u reazzjonijiet manijaċi kienu rrappurtati f'pazjenti kkurati b'ziconotide.
English: In one clinical study a male cancer patient received an accidental IT ziconotide overdose of 744 μg over a 24-hour period (31 μg/hour) and resumed treatment at the intended dose after experiencing a reduction in Visual Analog Scale of Pain Intensity (VASPI) from 82 to 2.5 mm.
Maltese: Fi studju kliniku, pazjent raġel bil-kanċer, irċieva doża eċċessiva ta' 744 μg ta' ziconotide IT b'mod aċċidentali fuq perijodu ta' 24 siegħa (31 μg/siegħa) u kompla l-kura bid-doża intenzjonata wara li ġarrab tnaqqis fil-Visual Analog Scale of Pain Intensity (VASPI) minn 82 għal 2.5 mm.
English: EU/1/04/302/003 - 5 ml solution for infusion.
Maltese: EU/1/04/302/003 - 5 ml soluzzjoni għall-infużjoni.
English: LIST OF EXCIPIENTS methionine, sodium chloride, water for injections, hydrochloric acid and sodium hydroxide.
Maltese: TA' EĊĊIPJENTI methionine, sodium chloride, ilma għall-injezzjonijiet, hydrochloric acid u sodium hydroxide.
English: Two short-term studies, 95-001 (malignant pain) and 96-002 (non malignant pain), involving 366 patients, demonstrated the efficacy of IT ziconotide in severe chronic pain using the percent change in Visual Analog Scale of Pain Intensity (VASPI) as the primary efficacy measure.
Maltese: Żewġ studji li damu ftit, 95-001 (uġigħ malinn) u 96-002 (uġigħ mhux malinn), li kienu jinvolvu 366 pazjent, urew l-effikaċja ta' ziconotide IT f'uġigħ kroniku sever bl-użu tal-bidla perċentwali fil-Visual Analog Scale of Pain Intensity (VASPI) bħala l-kejl ta' l-effikaċja primarja.
English: Prialt is supplied in packs containing a single vial of either 1 ml, 2 ml or 5 ml.
Maltese: Prialt hu fornut f'pakketti li fihom kunjett wieħed ta' jew 1 ml, 2 ml jew 5 ml.
English: Following one-hour IT administration (1 - 10 μg), both cumulative exposure (AUC; range: 83.6608 ng/h/ml) and peak exposure (Cmax; range: 16.4 - 132 ng/ml) values were variable and dose-dependent, but appeared only approximately dose-proportional.
Maltese: Wara l-għoti IT ta' siegħa (1 - 10 μg), kemm l-espożizzjoni kumulattiva (AUC; medda: 83.6608 ng/siegħa/ml) kif ukoll l-espożizzjoni massima (Cmax; medda: 16.4 - 132 ng/ml) il-valuri kienu varjabbli u jiddependu mid-doża, iżda dehru biss li kienu biss bejn wieħed u ieħor proporzjonali għaddoża.
English: Based on very limited clinical investigations, both angiotensin converting enzyme inhibitors (e.g., benazepril, lisinopril and moexipril) and HIV protease inhibitors (e.g., ritonavir, saquinavir, indinavir), have no readily apparent effect on plasma ziconotide exposure.
Maltese: Fuq bażi ta' investigazzjonijiet limitati ħafna, kemm linibituri ta' l-enzimi li jibdlu angiotensin (eż., benazepril, lisinopril u moexipril) u inibituri ta' l-HIV protease (eż., ritonavir, saquinavir, indinavir), m'għandhom l-ebda effett apparenti fil-pront fuq lespożizzjoni ta' ziconotide fuq il-plażma.
English: Type I glass vials with butyl rubber stoppers coated with fluorinated polymer.
Maltese: Kunjetti singoli tal-ħġieġ ta' Tip I, b'tappijiet tal-lastku tal-butyl miksija bil-fluorinated polymer.
English: Investigations blood creatine phosphokina se increased, weight decreased electrocardiogram abnormal, aspartate aminotransferase increased, blood creatine phosphokinase MM increased, body temperature increased a. From spontaneous reporting
Maltese: Investigazzjonijiet żieda fil-creatine phosphokinase fid-demm, tnaqqis fil-piż elettrokardjogramma anormali, żieda f'aspartate aminotransferase, żieda fil-creatine phosphokinase MM fid-demm, żieda fittemperatura tal-ġisem a.
English: 1 vial of 1 ml 1ml
Maltese: 1 kunjett ta' 1 ml 1ml
English: However, ziconotide did not induce cell transformation in the in vitro Syrian hamster embryo (SHE) assay and did not increase cell proliferation (pre-neoplastic lesion formation) or apoptosis after subchronic intrathecal exposure in dogs.
Maltese: Madankollu, ziconotide ma kkawżax it-trasformazzjoni taċ-ċelluli fl-assaġġ in vitro tas-Syrian hamster embryo (SHE) u ma żiedx il-proliferazzjoni taċ-ċelluli (formazzjoni tal-leżjoni pre-neoplastika) jew apoptosi wara espożizzjoni sotto-kronika għal ġot-teka fil-klieb.
English: Very Common (≥ 1/10)
Maltese: Komuni ħafna (≥ 1/10)
English: Plasma concentrations following continuous (≥ 48 h) IT infusion (≤ 21.6 μg/day) appear to be relatively low and typically undetectable (i.e., about 80% of plasma samples collected from pain patients contain no quantifiable medicinal product; < 0.04 ng/ml).
Maltese: Il-konċentrazzjonijiet fil-plażma wara infużjoni IT kontinwa (≥ 48 sigħat) (≤ 21.6 μg/kuljum) jidhru li jkunu relattivament baxxi u tipikament ma jkunux jistgħu jiġu osservati (i.e., madwar 80% tal-kampjuni tal-plażma miġbura minn pazjenti li kellhom uġigħ ma fihom l-ebda prodott mediċinali li seta' jiġi kkwantifikat; < 0.04 ng/ml ).
English: Dose at end of titration (μg/hr) Mean Median Range aResponders were defined as those who experienced a ≥ 30% drop in VASPI score compared to baseline.
Maltese: Medja Medjan Medda aDawk li rrispondew kienu definiti bħala dawk li kellhom tnaqqis ta' ≥ 30% fil-punteġġ VASPI meta mqabbel mal-linja bażi.
English: The mean plasma elimination half-life (t½) is 1.3 hr. Ziconotide is a relatively small molecular weight peptide (MW = 2,639) and is filtered by the kidney glomerulus, but only minimal amounts of ziconotide (< 1%) are recovered in human urine following intravenous infusion.
Maltese: Ziconotide hu peptide li għandu piż molekulari relattivament żgħir (MW = 2,639) u hu ffiltrat mill-glomerulus tal-kliewi, iżda ammonti minimi biss ta' ziconotide (< 1%) huma rkuprati fl-awrina tal-bniedem wara infużjoni fil-vina.
English: Hence, ziconotide appears to be mainly eliminated from the CSF (mean t½ = 4.6 hr) by bulk flow of CSF out of the CNS through the arachnoid villi with subsequent transfer into the systemic circulation.
Maltese: Ghalhekk, ziconotide jidher li jkun primarjament eliminat mis-CSF (medja t½ = 4.6 siegħa) mill-fluss bulk ta' CSF ‘il barra mis-CNS mill-arachnoid villi bi trasferiment sussegwenti fiċ-ċirkolazzjoni sistemika.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per maximum recommended intrathecal dose (21.6 μg/day), i.e. essentially ‘sodium- free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża massima rakkomandata għal ġot-teka (21.6 μg/kuljum), jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Common (may affect 1 to 10 users in 100)
Maltese: Komuni (jistgħu jaffettwaw minn 1 sa 10 utenti minn kull 100)
English: Anaphylactic reactiona
Maltese: Reazzjoni anafilattikaa
English: The aetiologies of pain in studies 95-001 (malignant pain) and 96-002 (non-malignant pain) were varied and included bone pain (n = 38) mostly due to bone metastases (n = 34), myelopathy (n = 38), half of whom had spinal cord injury with paralysis (n = 19), neuropathy (n = 79), radiculopathy (n = 24), spinal pain (n = 91) mostly due to failed back surgery (n = 82), and other aetiologies (n = 82).
Maltese: L-etjoloġiji ta' l-uġigħ fi studji 95-001 (uġigħ malinn) u 96-002 (uġigħ mhux malinn) kienu varji u inkludew uġigħ fl-għadam (n = 38) l-iktar minħabba metastasi ta' l-għadam (n = 34), mjelopatija (n = 38), li nofshom kellhom korriment tas-sinsla flimkien ma' paralisi
English: In-use shelf-life (diluted product) Chemical and physical in use stability has been demonstrated for 60 days at 37°C.
Maltese: L-istabbiltà kimika u fisika waqt l-użu kienet murija għal 60 jum f'temperatura ta' 37°C.
English: EU/1/04/302/002 - 2 ml solution for infusion.
Maltese: EU/1/04/302/002 - 2 ml soluzzjoni għall-infużjoni.
English: Progressive elevation of the creatine kinase is uncommon.
Maltese: Elevazzjoni progressiva tal-creatine kinase mhix komuni.
English: CSF 23 0.38 ± 0.56
Maltese: N02BG08
English: The concentration of the solution used in the infusion pump must be no lower than 5 μg/ml ziconotide in an external pump and 25 μg/ml in an internal pump.
Maltese: Il-konċentrazzjoni tas-soluzzjoni użata fil-pompa ta' l-infużjoni trid tkun ta' mhux inqas minn 5 μg/ml ta' ziconotide f'pompa esterna u ta' 25 μg/ml f'pompa interna.
English: The plasma pharmacokinetics following intravenous doses (0.3 - 10 μg/kg/24 hr) were also studied.
Maltese: Il-farmakokinetiċi tal-plażma wara dożi fil-vina (0.3 - 10 μg/kg/24 siegħa) kienu studjati wkoll.
English: Prialt has been shown to be chemically and physically compatible with the implantable Synchromed pump and the external CADD-Micro pump at the concentration levels indicated above.
Maltese: Intwera li Prialt kien kimikament u fiżikament kompatibbli mal-pompa Synchromed li tista' tkun impjantata u l-CADD-Micro pump esterna fil-livelli ta' konċentrazzjoni indikati hawn fuq.
English: Each 2 ml vial contains 200 μg ziconotide (as acetate).
Maltese: Kull kunjett ta' 2 ml fih 200 μg ta' ziconotide (bħala acetate).
English: Prialt is supplied in packs containing a single vial of 20 ml.
Maltese: Prialt hu fornut f'pakketti li fihom kunjett wieħed ta' 20 ml.
English: - One ml solution contains 25 micrograms ziconotide (as acetate).
Maltese: - Soluzzjoni ta' 1 ml fiha 25 mikrogramma ta' ziconotide (bħala acetate).
English: Prialt contains the active substance ziconotide which belongs to a group of medicines, called analgesics or ‘painkillers'.
Maltese: Prialt fih is-sistanza attiva ziconotide li tappartjeni għal grupp ta' mediċini, imsejħa analġeżiċi jew ‘painkillers'.
English: Pharmacotherapeutic group: Analgesics, other analgesics and antipyretics, ATC code: N02BG08
Maltese: Analġesiċi, analġesiċi u mediċini oħrajn kontra d-deni, Kodiċi ATC:
English: Medicinal products that affect specific peptidases/proteases would not be expected to impact upon ziconotide plasma exposure.
Maltese: Prodotti mediċinali li jaffettwaw peptidases/proteases speċifiċi mhumiex mistennija li jkollhom impatt fuq l-espożizzjoni tal-plażma ta' ziconotide.
English: Caution should be exercised when ziconotide is administered to patients who are receiving systemic chemotherapy (see section 4.5).
Maltese: Għandha tingħata attenzjoni meta ziconotide jingħata lil pazjenti li jkunu qegħdin jirċievu kimoterapija sistemika (ara sezzjoni 4.5).
English: Nervous system disorders dizziness, nystagmus, memory impairment, headache, somnolence dysarthria, amnesia, dysgeusia, tremor, balance impaired, ataxia, aphasia, burning sensation, sedation, paraesthesia, hypoaesthesia, disturbance in attenti on, speech disorder, areflexia, coordination abnorm al, dizziness postural, cognitive disorder, hyperaesthesia, hyporeflexia, ageusia, depressed level of consciousness, dysaesthesia, parosmia, mental impairment incoherence, loss of consciousness, coma, stupor, convulsions, cerebrovascular accident, encephalopathy
Maltese: Disturbi fis-sistema nervuża sturdament, nistagmus, indeboliment talmemorja, uġigħ ta' ras, ngħas disartrija, amnesija, disgewżja, rogħda, indeboliment fil-bilanċ, atassja, afasja, sensazzjoni ta' ħruq, sedazzjoni, parestesija, ipoestesija, disturb fl-attenzjoni, taħwid fid-diskors, assenza ta' riflessi, koordinazzjoni anormali, sturdament li jiddependi mill-qagħda, disturb konjittiv, iperestesija, hyporeflexia, telf tas-sens tat-togħma, livell baxx ta' koxjenza, disestesija, parosmija, indeboliment mentali inkoerenza, tintilef minn sensik, koma, sturdament, konvulżjonijiet, inċident ċerebrovaskulari, enċefalopatija
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 25 micrograms ziconotide (as acetate) Each vial contains 500 micrograms ziconotide (as acetate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull 1 ml fih 25 mikrogramma ta' ziconotide (bħala acetate)
English: Symptoms of rhabdomyolysis are abnormal urine colour (brown coloured), reduced urine production, muscle weakness, muscle aching and muscle tenderness.
Maltese: Sintomi ta' rabdomijolosi huma kulur mhux normali tal-awrina (lewn kannella), nuqqas ta' produzzjoni ta' awrina dgħufija fil-muskoli, uġigħ fil-muskoli u sensittività tal-muskoli.
English: If dilution is required, Prialt must be diluted aseptically with preservative-free sodium chloride 9 mg/ml (0.9%) solution for injection before use.
Maltese: Jekk id-dilwizzjoni tkun meħtieġa, Prialt irid jiġi dilwit b'mod asettiku b'sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni mingħajr preservattivi qabel l-użu.
English: Each 5 ml vial contains 500 μg ziconotide (as acetate).
Maltese: Kull kunjett ta' 5 ml fih 500 μg ta' ziconotide (bħala acetate).
English: The biological activity of the various expected proteolytic degradation products has not been assessed.
Maltese: L-attività bijoloġika mistennija tal-prodotti proteolitiċi varji taddegradazzjoni ma kienitx evalwata.
English: The maximum recommended intrathecal dose is 21.6 μg/day.
Maltese: Id-doża massima rakkomandata ġot-teka hi ta' 21.6 μg/kuljum.