FrancophonIA/ELRC3.0 huggingface dataset:
English: After intravenous administration of 0.03 mmol/kg dose the mean half-life of the distribution phase (t1/2) was 0.48 ± 0.11 hours and the volume of distribution at steady state was 148 ± 16 ml/kg, roughly equivalent to that of extracellular fluid.
Maltese: Wara l-għoti ġol-vini ta' doża ta' 0.03 mmol/kg, il-medja talhalf-life tal-fażi tad-distribuzzjoni (t1/2α) kienet ta' 0.48 ± 0.11 ta' siegħa u l-volum tad-distribuzzjoni fl-istat fiss kien ta' 148 ± 16 ml/kg, bejn wieħed u ieħor ekwivalenti għal dak tal-fluwidu ekstraċellulari.
English: Stomach pain
Maltese: Spażmi muskolari
English: No functional impairment was observed and electron microscopic investigations of the rat kidneys indicated that the observed vacuolation was primarily a storage phenomenon.
Maltese: L-ebda indeboliment funzjonali ma kien osservat, u investigazzjoni tal-kliewi tal-firien permezz ta' mikroskopju tal-elettroni, indikat li l-vakwolazzjoni osservata kienet primarjament fenomenu tal-ħażna.
English: • breathing difficulties and/or heart/ pulse-rate/ blood pressure disturbances which may lead to consciousness disorders respiratory reactions, and /or cardiovascular manifestations
Maltese: • diffikultajiet respiratorji u/jew tal-qalb/rata tal-polz/pressjoni tad-demm li jistgħu jwasslu għal disturbi li fihom iħossok ħażin, reazzjonijiet respiratorji, u/jew manifestazzjonijiet kardjovaskulari li jistgħu jwasslu għal xokk.
English: Problems with the electrical rhythm of the heart (long QT) High blood pressure
Maltese: Problemi bir-ritmu elettriku tal-qalb (QT twil) Pressjoni għolja tad-demm
English: Atrioventricular block first Electrocardiogram QT
Maltese: Imblukkar atrijoventrikolari tal-elettrokardjogramma
English: In vitro studies using human liver microsomes did not indicate any potential to inhibit the cytochrome P 450 enzyme system.
Maltese: Studji in vitro li użaw mikrosomi tal-fwied uman ma indikaw l-ebda potenzjal li jinibixxi s-sistema talenzima taċ-ċitokromju P 450.
English: The anticoagulant activity of warfarin was not altered and the efficacy of the medicinal product was not influenced.
Maltese: L-attività kontra l-koagulazzjoni ta' warfarin ma nbidlitx u l-effikaċja tal-prodott mediċinali ma ġietx influwenzata.
English: 1, 5 or 10 injection vials with 10 ml solution for injection (in 10-ml glass vial) 1, 5 or 10 injection vials with 15 ml solution for injection (in 20-ml glass vial) 1, 5 or 10 injection vials with 20 ml solution for injection (in 20-ml glass vial) Not all pack sizes may be marketed.
Maltese: Kunjetti ta' 1, 5 jew 10 ml × 10 ml (f'kunjett tal-ħġieg ta' 10 ml) Kunjetti ta' 1, 5 jew 10 ml × 15 ml (f'kunjett tal-ħġieg ta' 20 ml) Kunjetti ta' 1, 5 jew 10 ml × 20 ml (f'kunjett tal-ħġieg ta' 20 ml)
English: The table below reports adverse reactions by MedDRA system organ classes (MedDRA SOCs).
Maltese: It-tabella hawn taħt tirrapporta reazzjonijiet avversa bis-sistema tal-klassifika tal-organi MedDRA (MedDRA SOCs).
English: Hyperglycaemia Electrolyte imbalance (incl.
Maltese: Ipergliċemija, Żbilanċ flElektroliti (inkl.
English: Injection site inflammation
Maltese: Infezzjonijiet u infestazzjonijiet
English: Chest pressure sensation Injection site thrombosis Injection site bruising Injection site inflammation Injection site burning Injection site extravasation Injection site haemorrhage Injection site pruritus Sensation of pressure
Maltese: Uġigħ fantażma fid-driegħ jew ir-riġlejn Livelli baxxi jew għoljin ta' potassju fid-demm Livelli għoljin ta' sodju fid-demm.
English: A small portion of gadofosveset dose was recovered in the faeces (4.7%, range 1.1 - 9.3%), indicating a minor role of biliary excretion in the disposition of gadofosveset.
Maltese: Porzjon żgħir tad-doża ta' gadofosveset kien irkuprat fl-ippurgar (4.7%, medda 1.1 - 9.3%), li jindika rwol żgħir tat-tneħħija mill-bila fid-dispożizzjoni ta' gadofosveset.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropeja dwar ilMediċini http://www.ema.europa.eu
English: Proteins in the urine
Maltese: Proteini fl-awrina
English: Ablavar should be administered as a single intravenous bolus injection, manually, or by magnetic resonance injector over a period of time up to 30 seconds followed by a 25-30 ml normal saline flush.
Maltese: Dan il-prodott mediċinali għandu jingħata bħala injezzjoni ta' bolus ġol-vina, b'mod manwali jew b'injettur tar-reżonanza manjetika (injettur RM) fuq perijodu ta' ħin li jdum sejjer sa 30 sekonda segwit bi flaxx ta' 25 -30 ml ta' salina normali.
English: In a clinical trial it was shown that gadofosveset can effectively be removed from the body by dialysis using high flux filters.
Maltese: Fi prova klinika ntwera li gadofosveset jista' jitneħħa effettivament mill-ġisem b'dijaliżi bl-użu ta' filtri high flux.
English: Excipients: fosveset, sodium hydroxide, hydrochloric acid, water for injections See the leaflet for further information.
Maltese: Sustanzi mhux attiva: fosveset, sodium hydroxide, hydrochloride acid, ilma għall-injezzjonijiet Ara l-fuljett għal aktar tagħrif.
English: Ablavar 0.25 mmol/ml solution for injection
Maltese: Ablavar 0.25 mmol/ml soluzzjoni għall-injezzjoni.
English: 0.05 mmol/kg at 20 MHz.
Maltese: -1s-1 fil-medda tad-doża sa 0.05 mmol/kg f'20
English: The following information is intended for medical or healthcare professionals only:
Maltese: Meta tuża mediċini oħra:
English: Most of the side effects (80%) occurred within 2 hours.
Maltese: Ħafna mill-effetti kollaterali (80 %) seħħew fi żmien sagħtejn.
English: Muscle tightness Sensation of heaviness
Maltese: Twissija dwar sensittività eċċessiva
English: Use of Ablavar should be avoided in patients with severe renal impairment (GFR < 30 ml/min/1.73 m2) and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI) (see section 4.4).
Maltese: L-użu ta' Ablavar għandu jiġi evitat f'pazjenti li għandhom indeboliment renali sever (GFR < 30 ml/min/1.73 m2) u f'pazjenti li qegħdin fil-perijodu perioperattiv ta' trapjant tal-fwied kemm-il darba l-informazzjoni dijanjostika hi essenzjali u mhix disponibbli b'immaġini ta' reżonanza manjetika (MRI) mhux imtejjeb b'kuntrast (ara sezzjoni 4.4).
English: During the dialysis sessions the mean half-life of plasma concentration decline was in the range 5-6 hours.
Maltese: Waqt is-sessjonijiet tad-dijaliżi, il-medja tnaqqis tal-half-life tal-konċentrazzjoni tal-plażma kienet fil-medda ta' 5-6 sigħat.
English: Muscle contractions involuntary
Maltese: Sustanza mhux attiva
English: Anxiety Confusion
Maltese: Ansjetà, Konfużjoni
English: Pain in limb Neck pain Muscle cramps Muscle spasms
Maltese: Tħoss il-kesħa fis-sit tal-injezzjoni Ħmura tal-ġilda fis-sit tal-injezzjoni Demm fl-awrina
English: In a clinical study, it was shown that gadofosveset does not affect the unbound fraction of warfarin in plasma.
Maltese: Fi studju kliniku, intwera li gadofosveset ma jaffettwax il-porzjon mhux imwaħħal ta' warfarin filplażma.
English: Cellulitis Urinary tract infection
Maltese: Ċellulite Infezzjoni tal-apparat
English: The high-flux dialysis filter was more efficient compared to the low-flux filter, therefore, use of a high-flux dialysis filter is recommended.
Maltese: Id-dijaliżi permezz ta' filtru high-flux kienet aktar effiċjenti meta mqabbla ma' filtru low flux, u għalhekk l-użu ta' filtru high-flux tad-dijaliżi hu rakkomandat.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: Each vial of 20 ml solution contains 4.88 g (5.00 mmol) of gadofosveset trisodium equivalent to 4.54g gadofosveset.
Maltese: Kull kunjett ta' soluzzjoni ta' 20 ml fih total ta' 4.88 g (5.00 mmol) ta' gadofosveset trisodium ekwivalenti għal gadofosveset 4.54g.
English: Electrocardiogram ST segment depression, Electrocardiogram T wave amplitude decreased
Maltese: Fibrillazzjoni atrijali Palpitazzjonijiet Depressjoni tas-segment ST tal-elettrokardjogramma, Amplitude tal-mewġa T mnaqqsa talelettrokardjogramma
English: Each vial of 15 ml solution contains a total of 3.66 g (3.75 mmol) of gadofosveset trisodium equivalent to 3.41g of gadofosveset.
Maltese: Kull kunjett ta' soluzzjoni ta' 15 ml fih total ta' 3.66 g (3.75 mmol) ta' gadofosveset trisodium ekwivalenti għal gadofosveset 3.41g.
English: Vials containing Ablavar are not intended for the withdrawal of multiple doses.
Maltese: Kunjetti li fihom Ablavar mhumiex intenzjonati għal ġbid ta' dożi multipli.
English: There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs) associated with use of other gadolinium-containing contrast agents.
Maltese: Kien hemm rapporti ta' fibrosi sistemika nefroġenika (li tikkawża twebbis u tista' taffettwa wkoll it-tessut artab u l-organi interni) li kien assoċjat mal-użu ta' sustanzi oħra ta' kuntrast li fihom gadolinju.
English: Cases of nephrogenic systemic fibrosis (NSF) have been reported with other gadolinium-containing contrast agents (see section 4.4).
Maltese: Każijiet iżolati ta' fibrosi sistemika nefroġenika (NSF) ġew rapportati f'pazjenti li ġew mogħtija wkoll sustanzi ta' kuntrast oħra li fihom gadolinju (ara sezzjoni 4.4).
English: Micturition urgency Renal pain Urinary frequency
Maltese: Uġigħ fil-kliewi Frekwenza tal-awrina
English: This medicine is given as a rapid injection into a vein by a medical professional only.
Maltese: Din il-mediċina tingħata bħala injezzjoni li tingħata malajr ġol-vina minn professjonist mediku biss.
English: What Ablavar contains - The active substance is gadofosveset.
Maltese: Is-sustanza attiva hija gadofosveset.
English: Each vial of 15 ml solution contains 3.66 g (3.75 mmol) of gadofosveset trisodium equivalent to 3.41g gadofosveset .
Maltese: Kull kunjett ta' soluzzjoni ta' 15 ml fih 3.66 g (3.75 mmol) ta' gadofosveset trisodium ekwivalenti għal gadofosveset 3.41g.
English: Due to the possibility of severe hypersensitivity reactions after intravenous contrast administration, preparedness for institution of emergency measures is necessary, e.g., appropriate medicinal products, an endotracheal tube, and a respirator should be at hand.
Maltese: emerġenza hu meħtieġ, eż., prodotti mediċinali adattati, tubu endotrakeali, u respiratur għandhom ikunu disponibbli.
English: This medicine is used together with an imaging technique called magnetic resonance imaging (MRI).
Maltese: Din il-mediċina tintuża flimkien ma' teknika tal-immaġni li tissejjaħ immaġni tar-reżonanza manjetika (MRI).
English: Shivering
Maltese: Sturdament
English: Ablavar 0.25 mmol/ml solution for injection Gadofosveset
Maltese: Ablavar 0.25 mmol/ml soluzzjoni għal użu ġol-vina.
English: - The other ingredients are fosveset, sodium hydroxide, hydrochloric acid, and water for injections.
Maltese: Is-sustanzi l-oħra huma fosveset, sodium hydroxide, hydrochloric acid, u ilma għallinjezzjonijiet.
English: Pruritus
Maltese: PSURs
English: Tiredness
Maltese: Remettar
English: Based on clinical trial experience in more than 1,800 patients, the following adverse reactions have been observed.
Maltese: Tagħrif mill-provi kliniċi Ibbażat fuq esperjenza f'aktar minn 1,800 pazjent, ir-reazzjonijiet avversi li ġejjin ġew osservati.
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Maltese: Tużax Ablavar wara d-data ta' skadenza li tidher fuq it-tikketta wara EXP.
English: In rabbits, an increased number of early resorptions and a slight but significant increase in the number of foetal anomalies (in particular hydrocephalus and malrotated limbs) were observed at doses at which no or slight maternal toxicity was observed (exposure was 2 and 5 times the expected human exposure, respectively).
Maltese: Fil-fniek, seħħ numru akbar ta' assorbimenti mill-ġdid bikrija, u żieda żgħira iżda sinifikanti finnumru ta' anomaliji tal-fetu (b'mod partikulari, idroċefalu u saqajn mhux imdawrin sewwa) kienu osservati f'dożi li fihom ma kienet osservata l-ebda jew ftit li xejn tossiċità materna, (l-espożizzjoni kienet ta' 2 u 5 darbiet rispettivament tal-espożizzjoni umana mistennija).
English: Haematuria, Microalbuminuria, Glycosuria
Maltese: Reazzjoni anafilattojda, Pressjoni baxxa, Arterosklerosi
English: Heartbeat irregularity/disturbed heart-chamber contractions (cardiac flutter, atrial fibrillation) problems with the electrical rhythm of the heart (ST segment/T wave abnormalities) Chest pain
Maltese: Żieda fit-tnixxija ta' dmugħ Disturbi fis-sinjali tan-nervi lejn il-qalb (l-ewwel grad) Qalb tħabbat malajr
English: 1 ml Ablavar solution contains 244 mg (0.25 mmol) gadofosveset trisodium equivalent to 227 mg of gadofosveset.
Maltese: 1 ml ta' soluzzjoni Ablavar fih 244 mg (0.25 mmol) ta' gadofosveset trisodium ekwivalenti għal gadofosveset 227mg.
English: Genital itching
Maltese: Tregħid
English: Pharmacotherapeutic group: Contrast media, paramagnetic contrast media, ATC code: V08CA.
Maltese: Midja ta' kuntrast, midja ta' kuntrast paramanjetiku, Kodiċi ATC:
English: Each vial of 10 ml solution contains a total of 2.44 g (2.50 mmol) of gadofosveset trisodium equivalent to 2.27 g of gadofosveset
Maltese: Kull kunjett ta' soluzzjoni ta' 10 ml fih total ta' 2.44 g (2.50 mmol) ta' gadofosveset trisodium ekwivalenti għal gadofosveset 2.27g.
English: Because of the lack of information on repeated administration, Ablavar injections should not be repeated unless the interval between injections is at least 7 days.
Maltese: Minħabba n-nuqqas ta' informazzjoni f'każ ta' amministrazzjoni ripetuta ta' Ablavar, l-injezzjonijiet m'għandhomx jiġu ripetuti sakemm l-intervall bejn l-injezzjonijiet ikun tal-anqas ta' 7 ijiem.
English: In the situation of elevated levels of gadofosveset or underlying QT prolongation the patient should be carefully observed including cardiac monitoring.
Maltese: F'sitwazzjoni ta' livelli għolja ta' gadofosveset jew titwil tal-QT bażiku, il-pazjent għandu jiġi osservat bl-attenzjoni, inkluż il-monitoraġġ kardijaku.
English: The mean dialysis clearance was between the range of 16-32 ml/h/kg.
Maltese: Il-medja tat-tneħħija tad-dijaliżi kienet fil-medda ta' 16-32 ml/h/kg.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq jimpenja ruħu li jwettaq l-istudji u l-attivitajiet addizzjonali ta' farmakovigilanza kif inhu deskritt fil-Pjan ta' Farmakoviġilanza, kif inhu deciż fl-verżjoni 2.0 tas-Sistema ta' l-Immaniġġar tar-Riskju inkluz f' Modulu 1.8.2 tal-Applikazzjoni għall-awtorizzazzjoni għat-Tqegħid fis-Suq u aġġornamenti sussegwenti tas-Sistema ta' l-Immaniġġar tar-Riskju kif deciż mill-Kumitat ghall-Prodotti Mediċinali għall-Użu Uman tal-Aġenzija Ewropeja dwar il-Mediċini (CHMP).
English: As there is a possibility that NSF may occur with Ablavar, it should therefore be avoided in patients with severe renal impairment and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI.
Maltese: Peress li hemm possibilità li jista' jkun hemm NSF, Ablavar għandu jiġi evitat f'pazjenti b'indeboliment tal-kliewi sever u f'pazjenti fil-perijodu perioperattiv ta' trapjant tal-fwied sakemm l-informazzjoni dijanjostika hija essenzjali u mhix disponibbli b'MRI mhux imtejjeb b'kuntrast.
English: Hypoesthesia Parosmia
Maltese: Ipoklaċimja)
English: As the renal clearance of gadofosveset may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.
Maltese: Peress li t-tneħħija ta' gadofosveset tista' tiġi indebolita fl-anzjani, huwa partikolarment importanti li l-pazjenti li għandhom 65 sena jew aktar jiġu skrinjati għal funzjoni mhux tajba tal-kliewi
English: Gadolinium containing contrast agents are excreted into breast milk in very small amounts (see section 5.3).
Maltese: Sustanzi ta' kuntrast li fihom gadolinium jiġu eliminate fil-ħalib tas-sider fi kwantitajiet żgħar ħafna (ara sezzjoni 5.3).
English: What Ablavar looks like and contents of the pack
Maltese: Id-dehra ta' Ablavar u l-kontenuti tal-pakkett:
English: Lower abdominal pain
Maltese: GĦAMLA KWALITATTIVA
English: Hallucination Abnormal dreams
Maltese: Sensazzjoni mhux normali fl-għajn Astenopatija
English: After first opening, the medicine should be used immediately.
Maltese: Ma ġiex ippruvat li din il-mediċina tista' tintuża mingħajr periklu waqt it-tqala.
English: Since gadofosveset is cleared from the body primarily by urinary excretion, caution should be exercised in patients with impaired renal function (see section 4.2 and 5.2).
Maltese: Minħabba li gadofosveset jitneħħa mill-ġisem primarjament permezz tal-eskrezzjoni mill-awrina, għandha tingħata attenzjoni lil dawk il-pazjenti li jkollhom indeboliment fil-funzjoni tal-kliewi (ara sezzjoni 4.2 u 5.2).
English: EU/1/05/313/009 Ablavar-0.25 mmol/ml-Solution for injection-Intravenous use-Vial (glass)-20ml-10 vials
Maltese: EU/1/05/313/009 Ablavar-0.25 mmol/ml-Soluzzjoni għall-injezzjoni-Użu għal ġol-vini-Kunjett (ħġieġ)-20 ml-10 kunjetti
English: 1, 5, or 10 vials  10 ml (in 10-ml glass vial)
Maltese: 1, 5 jew 10 kunjett għall-injezzjoni b' 10 ml ta' soluzzjoni għall-injezzjoni (f'kunjett tal-ħġieġ ta' 10ml)
English: Each vial of 10 ml solution contains 2.44 g (2.50 mmol) of gadofosveset trisodium equivalent to 2.27g gadofosveset.
Maltese: Kull kunjett ta' soluzzjoni ta' 10 ml fih 2.44 g (2.50 mmol) ta' gadofosveset trisodium ekwivalenti għal gadofosveset 2.27g.
English: EU/1/05/313/008 Ablavar-0.25 mmol/ml-Solution for injection-Intravenous use-Vial (glass)-20ml-5 vials
Maltese: EU/1/05/313/008 Ablavar-0.25 mmol/ml-Soluzzjoni għall-injezzjoni-Użu għal ġol-vini-Kunjett (ħġieġ)-20 ml-5 kunjetti
English: 1, 5, or 10 vials  20 ml (in 20-ml glass vial)
Maltese: 1, 5 jew 10 kunjett għall-injezzjoni b' 20 ml ta' soluzzjoni għall-injezzjoni (f'kunjett tal-ħġieġ ta' 20ml)
English: Dynamic imaging begins immediately upon injection.
Maltese: Immaġni dinamika tibda dritt malli ssir l-injezzjoni.
English: Ablavar is for diagnostic use only.
Maltese: Ablavar jista' jiġi eliminat b'emodijalisi.
English: Electrocardiogram abnormal
Maltese: Elettrokardjogramma mhux
English: EU/1/05/313/007 Ablavar-0.25 mmol/ml-Solution for injection-Intravenous use-Vial (glass)-20ml-1 vial
Maltese: EU/1/05/313/007 Ablavar-0.25 mmol/ml-Soluzzjoni għall-injezzjoni-Użu għal ġol-vini-Kunjett (ħġieġ)-20 ml-1 kunjett
English: Dizziness (excl. Vertigo) Tremor
Maltese: Sturdament (eskl.
English: EU/1/05/313/005 Ablavar-0.25 mmol/ml-Solution for injection-Intravenous use-Vial (glass)-15ml-5 vials
Maltese: EU/1/05/313/005 Ablavar-0.25 mmol/ml-Soluzzjoni għall-injezzjoni-Użu għal ġol-vini-Kunjett (ħġieġ)-15 ml-5 kunjetti
English: Headache Paraesthesia Dysgeusia Burning sensation
Maltese: Reazzjoni bħal ta' allerġija
English: EU/1/05/313/003 Ablavar-0.25 mmol/ml-Solution for injection-Intravenous use-Vial (glass)-10ml-10 vials
Maltese: EU/1/05/313/003 Ablavar-0.25 mmol/ml-Soluzzjoni għall-injezzjoni-Użu għal ġol-vini-Kunjett (ħġieġ)-10 ml-10 kunjetti
English: Swelling and clotting in a vein Coldness in the fingers and toes
Maltese: Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura
English: Most of the adverse reactions were mild to moderate in intensity.
Maltese: Il-biċċa l-kbira taleffetti avversi kienu ta' intensità minn ħafifa sa moderata.
English: The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid, or cardiovascular reactions, or other idiosyncratic reactions should always be considered especially in those patients with a known clinical hypersensitivity, previous reaction of contrast media, a history of asthma, or other allergic disorders.
Maltese: Il-possibbiltà ta' reazzjoni, li tinkludi reazzjonijiet serji, li jkunu ta' periklu għall-ħajja, fatali, anafilattojdi jew kardjovaskulari, jew reazzjonijiet idjosinkratiċi oħrajn, għandhom dejjem jiġu kkunsidrati, speċjalment f'dawk il-pazjenti li hu magħruf li għandhom sensittività eċċessiva klinika, li diġà kellhom reazzjoni għas-sustanza tal-kuntrast, storja medika ta' ażżma, jew mard allerġiku ieħor.
English: EU/1/05/313/002 Ablavar-0.25 mmol/ml-Solution for injection-Intravenous use-Vial (glass)-10ml-5 vials
Maltese: EU/1/05/313/002 Ablavar-0.25 mmol/ml-Soluzzjoni għall-injezzjoni-Użu għal ġol-vini-Kunjett (ħġieġ)-10 ml-5 kunjetti
English: EU/1/05/313/006 Ablavar-0.25 mmol/ml-Solution for injection-Intravenous use-Vial (glass)-15ml-10 vials
Maltese: EU/1/05/313/006 Ablavar-0.25 mmol/ml-Soluzzjoni għall-injezzjoni-Użu għal ġol-vini-Kunjett (ħġieġ)-15 ml-10 kunjetti
English: Pharyngolaryngeal pain Abdominal discomfort
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Itching
Maltese: Tertir
English: Indigestion
Maltese: Indiġestjoni
English: Neck pain
Maltese: TAGĦRIF
English: EU/1/05/313/001 Ablavar-0.25 mmol/ml-Solution for injection-Intravenous use-Vial (glass)-10 ml-1 vial
Maltese: EU/1/05/313/001 Ablavar-0.25 mmol/ml-Soluzzjoni għall-injezzjoni-Użu għal ġol-vini-Kunjett (ħġieġ)-10 ml-1 kunjett
English: 1, 5, or 10 vials  15 ml (in 20-ml glass vial)
Maltese: 1, 5 jew 10 kunjett għall-injezzjoni b' 15 ml ta' soluzzjoni għall-injezzjoni (f'kunjett tal-ħġieġ ta' 20ml)
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute toxicity, local tolerance, contact-sensitising potential, and genotoxicity.
Maltese: Tagħrif ta' qabel l-użu kliniku bbażat fuq studji konvenzjonali dwar is-sigurtà farmakoloġika, it-tossiċità akuta, it-tolleranza lokali, il-potenzjal tas-sensibilizzazzjoni tal-kuntatt u l-ġenotossiċità, ma żvela l-ebda periklu speċjali għall-bnedmin.
English: Your doctor will discuss whether you should continue breast-feeding or interrupt breast-feeding for a period of 24 hours after you receive this medicine.
Maltese: It-tabib tiegħek ser jiddiskuti jekk għandekx tkompli tredda' jew twaqqaf it-treddigħ għal perijodu ta' 24 siegħa wara li tkun ħadt din il-mediċina.
English: In clinical trials using Ablavar, no specific trends were observed that would signify a potential interaction of the medicinal product with laboratory test methods.
Maltese: Fi studji kliniċi bl-użu ta' Ablavar, ma kienu osservati l-ebda andamenti speċifiċi li kieku kienu jfissru interazzjoni potenzjali tal-prodott mediċinali mal-metodi tat-testijiet tal-laboratorju.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml Ablavar solution for injection contains 244 mg (0.25 mmol) gadofosveset trisodium equivalent to 227 mg gadofosveset.
Maltese: 1 ml ta' soluzzjoni għall-injezzjoni Ablavar fih 244 mg (0.25 mmol) ta' gadofosveset trisodium ekwivalenti għal gadofosveset 227mg.
English: The results from various evaluations of plasma and urine samples indicated that gadofosveset does not undergo measurable metabolism.
Maltese: Ir-riżultati minn evalwazzjonijiet varji ta' kampjuni tal-plażma u awrina jindikaw li gadofosveset ma jġarrabx metaboliżmu li jista' jitkejjel.
English: Salivary hypersecretion Dyspepsia
Maltese: Karatteristiċi fil-pazjenti
English: Breast-feeding
Maltese: tal-awrina
English: Take special care with Ablavar
Maltese: Oqgħod attent ħafna b'Ablavar:
English: ATC Code: G04BE03.
Maltese: Kodiċi ATC: G04BE03.
English: 31-546, Krakow, Poland
Maltese: 31-546, Krakow, Il-Polonja
English: Stevens-Johnson Syndrome (SJS),* Toxic Epidermal Necrolysis (TEN)*
Maltese: Sindromu ta' Stevens-Johnson (SJS),* Nekrolisi tossika tal-ġilda (TEN) *