FrancophonIA/ELRC3.0 huggingface dataset:
English: Double-blind, randomised, placebo-controlled 24week study evaluating dapoxetine 30 mg and 60 mg p.r.n.
Maltese: Studju bi blindaġġ doppju, randomizzat, ikkontrollat bi plaċebo fuq 24-ġimgħa li evalwa dapoxetine 30 mg u 60 mg p.r.n.
English: All events of syncope observed in the Phase III clinical development program summarized in the MAA occurred before implementation of activities intended to minimize the occurrence of syncope, including the administration of patient instructions and the exclusion of orthostatic manoeuvres from the study designs, suggesting that syncope could be managed through patient and clinician instruction/education.
Maltese: III li tagħhom hemm sommarju fl-MAA seħħew qabel l-implimentazzjoni ta' attivitajiet maħsuba biex jimminimizzaw l-okkorrenza ta' sinkope, inkluż l-għoti ta' istruzzjonijiet għall-pazjenti u l-esklużjoni ta' manuvri ortostatiċi mill-disinji tal-istudju, li jissuġġerixxu li s-sinkope jista' jiġi mmaniġġjat permezz ta' edukazzjoni/struzzjoni tal-pazjent u tal-kliniku.
English: After the sponsor implemented risk minimization measures during the course of the two then-ongoing Phase III studies (R096769-PRE-3001 and R096769-PRE-3003), no further episodes of syncope were reported in those studies.
Maltese: Wara li l-isponsor implimenta miżuri għall-minimizzazzjoni tar-riskju matul il-kors taż-żewġ studji tal-Fażi III (R096769-PRE-3001 u R096769-PRE-3003) li kienu għaddejjin dak iż-żmien, ma kienx hemm rapporti ulterjuri ta' episodji ta' sinkope f'dawk l-istudji.
English: Therefore, the CHMP concluded that the benefit-risk of Priligy 30 mg and 60 mg is considered positive.
Maltese: Għalhekk, is-CHMP ikkonkluda li l-benefiċċju-riskju ta' Priligy 30 mg u 60 mg huwa kkunsidrat pożittiv.
English: More specifically, among responders to treatment (i.e., those subjects that reported at least a 2category increase in Control Over Ejaculation and at least a 1-category decrease in Personal Distress) in Study R096769-PRE-3001, regarding:
Maltese: B'mod aktar speċifiku, fost dawk li rrispondew għall-kura (jiġifieri, dawk is-suġġetti li rrapportaw mill-inqas żieda ta' żewġ kategoriji fuq Kontroll Fuq l-Eġakulazzjoni u mill-inqas tnaqqis ta' kategorija 1 fi Dwejjaq Personali) fl-Istudju R096769-PRE-3001, dwar:
English: It has been granted marketing authorisation in 25 countries worldwide, including 7 countries in the European Union which were part of a decentralised procedure with Sweden acting as reference Member State.
Maltese: Ingħata awtorizzazzjoni għat-tqegħid fis-suq f'25 pajjiż madwar id-dinja, inkluż 7 pajjiżi fl-Unjoni Ewropea li kienu parti minn proċedura deċentralizzata bl-Isvezja taġixxi bħala l-Istat Membru ta' referenza.
English: The objecting Member States pointed out that the increase in response noted for the 60mg strength compared to the 30 mg strength in the clinical studies is counteracted by the dose related increase in adverse events, especially the occurrence of syncope associated with loss of consciousness, bradycardia and asystole.
Maltese: L-Istati Membri li oġġezzjonaw enfasizzaw li ż-żieda fir-rispons innotata għall-qawwa tas-60mg meta mqabbla mal-qawwa tat-30 mg fl-istudji kliniċi ġiet newtralizzata miż-żieda fl-avvenimenti avversi relatata mad-doża, speċjalment l-okkorrenza ta' sinkope assoċjat ma' telf ta' konoxxenza, bradikardija u asystole.
English: Double-blind, randomised, placebo-controlled 9week study evaluating dapoxetine 60 mg p.r.n.
Maltese: Studju bi blindaġġ doppju, randomizzat, ikkontrollat bi plaċebo fuq 9-ġimgħat li evalwa dapoxetine 60 mg p.r.n. u 60 mg q.d.
English: Because of that, the MAH conducted exploratory analyses to compare the effect of dapoxetine 60 mg to that of dapoxetine 30 mg.
Maltese: Minħabba dak, il-MAH wettaq analiżi esploratorja biex iqabbel l-effett ta' dapoxetine 60 mg ma' dak ta' dapoxetine 30 mg.
English: SSRI class-related adverse effects were not apparent with dapoxetine treatment when evaluated with specific instruments in studies that assessed treatment with dapoxetine 60 mg p.r.n.
Maltese: Ma kinux evidenti effetti avversi relatati mal-klassi tal-SSRI permezz tal-kura bi dapoxetine meta evalwati permezz ta' strumenti speċifiċi fi studji li evalwaw kura bi dapoxetine 60 mg p.r.n. u 60 mg q.d. sa 24 u 9 ġimgħat, rispettivament.
English: These findings suggest that syncope associated with the administration of dapoxetine is vasovagal in etiology.
Maltese: Dawn is-sejbiet jissuġġerixxu li sinkope assoċjat mal-għoti ta' dapoxetine huwa vasovagali fl-etjoloġija.
English: The key efficacy endpoints were Intravaginal Ejaculation Latency Time (IELT) and percentage of responders based on Control Over Ejaculation and Personal Distress (at least a 2-category increase in Control Over Ejaculation and at least a 1-category decrease in Personal Distress).
Maltese: Il-punti ta' tmiem ewlenin tal-effikaċja kienu ż-Żmien ta' Dewmien għal Eġakulazzjoni Intravaġinali (IELT) u l-perċentwal ta' dawk li rrispondew abbażi ta' Kontroll Fuq l-Eġakulazzjoni u Dwejjaq Personali (mill-inqas żieda ta' żewġ kategoriji fuq il-Kontroll Fuq l-Eġakulazzjoni u mill-inqas tnaqqis ta' kategorija waħda fi Dwejjaq Personali).
English: Double-blind, randomised, placebo-controlled 12week study evaluating dapoxetine 30 mg and 60 mg p.r.n.
Maltese: Studju bi blindaġġ doppju, randomizzat, ikkontrollat bi plaċebo fuq 12-il ġimgħa li evalwa dapoxetine 30 mg u 60 mg p.r.n.
English: • Satisfaction With Sexual Intercourse, 64.4 % of responders reported "very poor" or "poor" satisfaction at baseline but 71.9% reported "good" or "very good" satisfaction at study end, compared with 91.6% of men without PE who reported "good" or "very good" satisfaction in the EU observational study (R096769-PRE-3004);
Maltese: 1% irrapportaw "lanqas xejn" jew "ftit biss" ta' dwejjaq fit-tmiem tal-istudju, meta mqabbla ma' 91.9% tal-irġiel mingħajr PE li rrapportaw "lanqas xejn" jew "ftit biss" ta' dwejjaq fl-istudju ta' osservazzjoni tal-UE (R096769-PRE-3004);
English: Efficacy and safety were documented in four Phase III studies of 12-24 weeks duration comparing dapoxetine 30 mg p.r.n and 60 mg p.r.n with placebo.
Maltese: L-effikaċja u s-sigurtà ġew dokumentati f'erba' studji tal-Fażi III li damu għaddejjin bejn 1224 ġimgħa li qabblu dapoxetine 30 mg p.r.n u 60 mg p.r.n ma' plaċebo.
English: Considering that PE is not a life-threatening disease, the added benefit of 60 mg compared to 30 mg (5-10% more responders) was considered too modest to outweigh the potentially increased risk for severe cases of syncope.
Maltese: Meta wieħed jikkunsidra li l-PE mhijiex marda ta' periklu għall-ħajja, il-benefiċċju miżjud ta' 60 mg meta mqabbel ma' 30 mg (5-10% aktar ta' dawk li rrispondew) kien ikkunsidrat bħala modest wisq biex jegħleb iż-żieda potenzjali fir-riskju għal każijiet severi ta' sinkope.
English: In the Phase III studies, the treatment benefit was measured in subjects who met the prespecified composite endpoint requiring functional benefit (i.e., improved control over ejaculation) as well as emotional benefit (i.e., decreased levels of distress) related to the latency of their ejaculation.
Maltese: Fl-istudji tal-Fażi III, il-benefiċċju tal-kura tqabbel f'suġġetti li ssodisfaw il-punt ta' tmiem kompost speċifikat minn qabel li kien jeħtieġ benefiċċju funzjonali (jiġifieri, titjib fil-kontroll fuq leġakulazzjoni) kif ukoll benefiċċju emozzjonali (jiġifieri, tnaqqis fil-livelli ta' dwejjaq) marbut maddewmien tal-eġakulazzjoni tagħhom.
English: In the analysis of the pooled data for the CGIC (Clinical Global Impression of Change) PRO (Patient Reported Outcome) measure the percentage of subjects reporting the two highest CGIG ratings of “better” or “much better” was 39.0% in the dapoxetine 60 mg group, 30.7% in the dapoxetine 30 mg group and 14.8% in the placebo group at Week 12.
Maltese: dapoxetine 60 mg, 30.7% fil-grupp ta' dapoxetine 30 mg u ta' 14.8% fil-grupp tal-plaċebo fit-12-il Ġimgħa.
English: It was also noted that the Phase III studies utilized a fixed-dose design, in which subjects who were randomly assigned to treatment with dapoxetine 60 mg were initiated on a 60-mg dose rather than the 30-mg dose, which is recommended in the Summary of Product Characteristics (SmPC).
Maltese: Ġie nnotat ukoll li l-istudji tal-Fażi III użaw disinn ta' doża fissa, li fiha s-suġġetti li kienu assenjati b'mod aleatorju għal kura bi dapoxetine 60 mg ġew mibdija fuq doża ta' 60 mg aktar milli fuq id-doża ta' 30 mg, li hija rakkomandata fis-Sommarju tal-Karatteristiċi tal-Prodott (SmPC).
English: On the basis of the available data the CHMP concluded that patients receiving Priligy 30 mg and 60 mg showed statistically significant response over patients receiving placebo.
Maltese: Abbażi tad-dejta disponibbli, is-CHMP ikkonkluda li l-pazjenti li kienu qegħdin jirċievu Priligy 30 mg u 60 mg urew rispons statistikament sinifikanti fuq il-pazjenti li kienu qegħdin jirċievu plaċebo.
English: Ref. EMEA/2672/2009
Maltese: EMEA/92128/2009
English: International non-proprietary name (INN): paliperidone
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): paliperidone
English: Invega is a medicine containing the active substance paliperidone.
Maltese: Invega hu mediċina li fiha s-sustanza attiva paliperidone.
English: What is Invega?
Maltese: X'inhu Invega?
English: Paliperidone acts mainly by blocking the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin), which are involved in bipolar I disorder.
Maltese: Il-paliperidone jaġixxi billi jimblokka r-riċetturi għad-dopamina u għal 5-idrossitripamina (5-hydroxytryptamine, imsejħa wkoll serotonina), newrotrasmettituri involuti fid-disturb bipolari tat-tip I.
English: The active substance in Invega, paliperidone, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Invega, paliperidone, hija mediċina antipsikotika.
English: On 15 December 2008, Janssen-Cilag International NV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Invega, to add the treatment of acute manic episodes associated with bipolar I disorder.
Maltese: Fil-15 ta' Diċembru 2008, Janssen-Cilag International NV għarrfet uffiċjalment lill-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għall-modifika fl-awtorizzazzjoni għat-tqegħid fis-suq għal Invega, li żżid it-trattament ta' episodji ta' maniji akuti assoċjati mad-disturb bipolari tat-tip I.
English: The CHMP was evaluating the initial documentation provided by the company.
Maltese: Is-CHMP kien qed jevalwa ddokumentazzjoni inizjali pprovduta mill-kumpanija.
English: Two of the studies compared Invega taken alone with placebo (a dummy treatment), one in 469 patients over three weeks and another in 493 patients over 12 weeks.
Maltese: Żewġ studji minnhom qabblu Invega meħud waħdu mal-plaċebo (trattament finta), wieħed f'469 pazjent fuq perjodu ta' tliet ġimgħat u l-ieħor f'493 pazjent fuq perjodu ta' 12-il ġimgħa.
English: The company presented the results of three main studies involving a total of 1,262 adults with bipolar I disorder who were having an acute manic episode.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' tliet studji ewlenin li involvew total ta' 1,262 adult li jbatu middisturb bipolari tat-tip I li kienu qed jesperjenzaw episodju ta' manija akut.
English: Invega was expected to be used to treat acute (sudden) manic episodes.
Maltese: Invega kien mistenni li jintuża fit-trattament ta' episodji ta' maniji akuti (għal għarrieda).
English: How is Invega expected to work?
Maltese: Għal xiex kien mistenni li jintuża Invega?
English: Paliperidone is an active breakdown product (metabolite) of risperidone, another antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s and in the treatment of bipolar I disorder since the early 2000s.
Maltese: Il-paliperidone hu prodott ta' skart (metabolita) attiv tar-risperidone, mediċina antipsikotika oħra li ilha tintuża fit-trattament tal-iskizofrenija sa mis-snin disgħin kif ukoll fit-trattament tad-disturb bipolari tat-tip I sa mill-ewwel snin tal-elfejnijiet.
English: Invega was also expected to be used in adults with bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal or depressed mood.
Maltese: Invega kien ukoll mistenni li jintuża fl-adulti li jbatu minn disturb bipolari tat-tip I, marda mentali li biha l-pazjenti jesperjenzaw episodji ta' maniji (perjodi anomali ta' burdata tajba), alternati b'perjodi ta' burdata normali jew depressa.
English: The third study compared the effects of Invega and placebo when they were taken together with either lithium or sodium valproate (other treatments for bipolar I disorder).
Maltese: It-tielet studju qabbel l-effetti ta' Invega u l-plaċebo meħudin flimkien mal-litju jew valproat tas-sodju (sodium valproate) (trattamenti oħra użati għad-disturb bipolari tat-tip I) Dan l-istudju involva 300 pazjent u dam għal sitt ġimgħat.
English: Invega is already used to treat schizophrenia, a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Maltese: Invega jintuża fit-trattament tal-iskizofrenija, marda mentali kkaratterizzata minn għadd ta' sintomi, fosthom disturbi fil-ħsieb u fid-diskors, alluċinazzjonijiet (il-pazjent jisma' jew jara affarijiet li ma jeżistux), suspetti u delirji (ħsibijiet żbaljati).
English: The 12-week study also included a group of patients treated with quetiapine taken alone (another treatment for bipolar I disorder).
Maltese: Listudju li dam 12-il ġimgħa inkluda wkoll grupp ta' pazjenti ttrattati bil-quetiapine meħuda waħedha (trattament ieħor użat għad-disturb bipolari tat-tip I).
English: In the brain, paliperidone attaches to several different receptors on the surface of nerve cells.
Maltese: Fil-moħħ, il-paliperidone jeħel ma' bosta riċetturi differenti fuq is-superfiċje taċ-ċelloli nervużi.
English: Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Invega
Maltese: Mistoqsija u tweġiba dwar l-irtirar tal-applikazzjoni għal modifika fl-awtorizzazzjoni għat-tqegħid fis-suq għal Invega
English: In all three studies, the main measure of effectiveness was the change in the severity of acute manic episodes, as measured using a standard symptom scale.
Maltese: Fit-tliet studji kollha, il-kejl ewlieni tal-effikaċja kien il-varjazzjoni fil-gravità tal-episodji ta' maniji akuti, imkejla bl-użu ta' skala standard għas-sintomi.
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Maltese: Dan ifixkel is-sinjali trasmessi bejn iċ-ċelloli tal-moħħ permezz ta' ‘newrotrasmettituri', sustanzi kimiċi li jħallu liċ-ċelloli nervużi jikkomunikaw ma' xulxin.
English: System Organ Class (MedDRA)
Maltese: Sistema tal-Klassifika tal-Organi (MedDRa)
English: Bayer Schering Pharma AG D - 13342 Berlin Germany
Maltese: Bayer Schering Pharma AG D - 13342 Berlin Il-Ġermanja
English: Repeated dose toxicity
Maltese: Tossiċità ta' doża ripetuti
English: Vascular stents
Maltese: Stents vaskulari
English: TMC Pharma Services Ltd., Finchampstead, Berkshire RG40 4LJ , UK Tel:01252 842255
Maltese: TMC Pharma Services Ltd., Finchampstead, Berkshire RG40 4LJ, Ir-Renju Unit Tel: 01252 842255
English: However, in a series of in vitro drug interaction studies (in 4.5 % human serum albumin and human plasma), gadofosveset demonstrated no adverse interaction with digitoxin, propranolol, verapamil, warfarin, phenprocoumon, ibuprofen, diazepam, ketoprofen, naproxen, diclofenac and piroxicam at clinically relevant concentrations.
Maltese: Madankollu, serje ta' studji dwar l-interazzjoni tal-mediċinia li saru in vitro (f'4.5 % tal-albumina tas-serum umana u plażma umana), gadofosveset ma wera l-ebda interazzjoni avversa ma' digitoxin, propranolol, verapamil, warfarin, phenprocoumon, ibuprofen, diazepam, ketoprofen, naproxen, diclofenac u piroxicam f'konċentrazzjonijiet klinikament rilevanti.
English: Rare ( 1/10,000 to  1/1,000)
Maltese: Rari (≥ 1/10,000 sa < 1/1,000)
English: Gadofosveset binds reversibly to human serum albumin.
Maltese: Gadofosveset jeħel b'mod riversibbli mal-albumina tas-serum umana.
English: Elderly (aged 65 years and above)
Maltese: Anzjani (65 sena u iżjed)
English: Uncommon ( 1/1,000 to  1/100)
Maltese: Mhux Komuni (≥ 1/1,000 sa < 1/100)
English: However, there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).
Maltese: Madanakollu mhemmx evidenza li l-emodijalisi huwa adattat għal prevenzjoni ta' fibrosi sistemika nefroġenika (NSF).
English: Laboratory test interactions
Maltese: Interazzjonijiet tat-testijiet tal-laboratorju
English: Involuntary muscle contractions Abnormal vision
Maltese: Kontrazzjonijiet involontarji fil-muskolu Vista anormali
English: Cardiac flutter Myocardial ischaemia Bradycardia
Maltese: Flutter tal-qalb Iskemija mijokardjali Bradikardja
English: Ablavar is a formulation of a stable gadolinium diethylenetriaminepentaacetic acid (GdDTPA) chelate substituted with a diphenylcyclohexylphosphate group (gadofosveset trisodium), for use in magnetic resonance imaging (MRI).
Maltese: Ablavar hu formulazzjoni ta' gadolinium diethylenetriaminepentaacetic acid (GdDTPA) chelate stabbli, sostitwit b'grupp ta' diphenylcyclohexylphosphate (gadofosveset trisodium), għall-użu flimmaġni tar-reżonanza manjetika (MRI).
English: TMC Pharma Services Ltd., Finchampstead, Berkshire RG40 4LJ, UK
Maltese: TMC Pharma Services Ltd., Finchampstead, Berkshire, RG40 4LJ, Ir-Renju Unit
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3 October 2005
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 3 t'Ottubru, 2005
English: In healthy volunteers, gadofosveset was predominantly eliminated in the urine with 84% (range 7994%) of the injected dose (0.03 mmol/kg) excreted in the urine in 14 days.
Maltese: F'voluntiera f'saħħithom, gadofosveset kien predominantement eliminat fl-awrina b'84% (medda 79-94%) tad-doża injettata (0.03 mmol/kg) imneħħija fl-awrina f'14-il jum.
English: After intravenous administration of 0.03 mmol/kg dose renal clearance (5.51 ± 0.85 ml/h/kg) and total clearance (6.57 ± 0.97 ml/h/kg) were similar, and mean terminal elimination half-life was 18.5 ± 3.0 hours.
Maltese: Wara l-għoti ġol-vini ta' doża ta' 0.03 mmol/kg, it-tneħħija millkliewi (5.51 ± 0.85 ml/h/kg) u t-tneħħija totali (6.57 ± 0.97 ml/h/kg) kienu simili, u l-medja tal-halflife tal-eliminazzjoni terminali kienet ta' 18.5 ± 3.0 sigħat.
English: Vascular disorders Vasodilatation
Maltese: Disturbi vaskulari Vażoliatazzjoni
English: Posology Adults: 0.12 ml/kg body weight (equivalent to 0.03 mmol/kg)
Maltese: Pożoloġija Adulti: 0.12 ml/kg ta' piż tal-ġisem (ekwivalenti għal 0.03 mmol/kg)
English: Sensation of pressure
Maltese: Sensazzjoni ta' pressjoni
English: 10 and 20 ml colourless type I glass vials with chloro- or bromobutyl elastomer stopper and aluminium bordered cap (plastic disk).
Maltese: Kunjetti ta' 10 u 20 ml tal-ħġieġ tip I, mingħajr kulur, b'għatu chloro- jew bromobutyl elastomer u b'tapp tal-aluminju (diska tal-plastik).
English: Because gadofosveset is bound to albumin, an interaction with other plasma protein bound active substances (e.g., ibuprofen and warfarin) is generally possible, i.e., a competition for the protein binding site can occur.
Maltese: Minħabba li gadofosveset jeħel mal-albumina, interazzjoni ma' sustanzi attivi oħrajn imwaħħlin malproteina tal-plażma (eż. ibuprofen u warfarin) hi ġeneralment possibbli, i.e., tista' sseħħ kompetizzjoni għas-sit fejn dawn jeħlu mal-proteina.
English: OUTER PACKAGING - BOX
Maltese: PAKKETT TA' BARRA - KAXXA
English: 5 vials
Maltese: 5 kunjetti)
English: No clinical experience is yet available for patients younger than 18.
Maltese: Għad m'hemm ebda esperjenza klinika għal pazjenti iżgħar minn 18-il sena.
English: In one subject with moderate hepatic impairment and abnormally low serum albumin, total clearance and half-life of gadofosveset was indicative of faster clearance compared to subjects with moderate hepatic impairment and normal serum albumin levels.
Maltese: F'pazjent wieħed li kellu indeboliment moderat tal-fwied u albumina tas-serum li kienet baxxa b'mod anormali, it-tneħħija totali u l-half-life ta' gadofosveset kienu indikattivi ta' tneħħija iktar mgħaġġla meta mqabbla ma' pazjenti b'indeboliment moderat talfwied u b'livelli normali ta' albumina tas-serum.
English: The usual safety precautions for magnetic resonance imaging must be observed, e.g., exclusion of cardiac pacemakers and ferromagnetic implants.
Maltese: Il-prekawzjonijiet tas-sigurtà tas-soltu għall-immaġni tar-reżonanza manjetika għandhom ikunu osservati, eż. l-esklużjoni ta' pacemakers kardijaċi u impjanti ferromanjetiċi.
English: Plasma pharmacokinetics and protein binding of gadofosveset were not significantly influenced by moderate hepatic impairment (Child Pugh B).
Maltese: Il-farmakokinetiċi tal-plażma u t-twaħħil mal-proteina ta' gadofosveset ma' kienux influwenzati b'mod sinifikanti minn indeboliment moderat tal-fwied (Child Pugh B).
English: A slight decrease in faecal elimination of gadofosveset was seen for the hepatic impaired subjects (2.7%) compared to normal subjects (4.8%).
Maltese: Tnaqqis żgħir fl-eliminazzjoni ta' gadofosveset mal-ippurgar kienet innutata f'pazjenti b'indeboliment tal-fwied (2.7%) meta mqabbla ma' persuni normali (4.8%).
English: Do not use Ablavar
Maltese: Tużax Ablavar:
English: 1 ml contains 227 mg gadofosveset equivalent to 244 mg/ml (0.25 mmol/millilitre) gadofosveset trisodium.
Maltese: 1 ml fih 227 mg gadofosveset ekwivalenti għal 244 mg/ml (0.25 mmol/millilitru) gadofosveset.
English: 10 ml
Maltese: INDIVIDWALI 10 ml
English: This medicine contains 6.3 mmol sodium (or 145 mg) per dose.
Maltese: Dan il-prodott mediċinali fih 6.3 mmol ta' sodium (jew 145 mg) kull doża.
English: Muscle tightness
Maltese: Ħmura tal-ġilda
English: After the injection you will be observed in case there might be any initial side effects.
Maltese: Wara l-injezzjoni inti ser tkun osservat/a fil-każ li jkun hemm xi effetti sekondarji inizjali.
English: Elevated levels of gadofosveset (e.g. repeated use in the short term [within 6-8 hours], or an inadvertent overdose > 0.05 mmol/kg) may be associated with mild QT prolongation (8.5 msec by Fridericia correction).
Maltese: Livelli għolja ta' gadofosveset (eż. użu ripetut fi żmien qasir [f'ħin ta' 6-8 sigħat], jew doża eċċessiva li tingħata b'mod aċċidentali ta' > 0.05 mmol/kg) tista' tkun marbuta ma' titwil ħafif tal-QT (8.5 msec bil-korrezzjoni ta' Fridericia).
English: Sodium hydroxide Hydrochloric acid Water for injection
Maltese: Sodium hydroxide Hydrochloride acid Ilma għall-injezzjonijiet
English: There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR< 30 ml/min /1.73 m2).
Maltese: Kien hemm rapporti ta' fibrożi sistemika nefroġenika (NSF) assoċjata mal-użu ta' xi sustanzi tal-kuntrast li fihom gadolinium f'pazjenti b'indeboliment renali sever akut jew kroniku (GFR < 30 ml/min/1.73 m2).
English: • you suffer from allergy (e.g. hay fever, hives) or asthma
Maltese: • jekk tbati minn allerġija (eż. hay fever, urtikarja) jew ażma
English: 10 ml solution contains 2.27 g, 15 ml solution contains 3.41g and 20 ml solution contains 4.54 g
Maltese: 10 ml ta' soluzzjoni fiha 2.27 g, 15 ml ta' soluzzjoni fiha 3.41 g u 20 ml ta' soluzzjoni fiha 4.54 g ta' gadofosveset f'kunjett.