FrancophonIA/ELRC3.0 huggingface dataset:
English: The elimination of Optimark in dogs younger than 3 months of age was significantly delayed because of immature renal function and resulted in a high systemic exposure to Optimark.
Maltese: L-eliminazzjoni ta' Optimark fi klieb iżgħar minn 3 xhur ġiet ittardjata b'mod sinifikanti minħabba funzjoni immatura tal-kliewi u rriżultat f'espożizzjoni għolja sistemika għal Optimark.
English: Insertion of a flexible in-dwelling venous catheter is recommended.
Maltese: L-inserzjoni ta' kateter venuż in-dwelling flessibbli hu rakkomandat.
English: Therefore, a rapid imaging sequence should be initiated 20 seconds after bolus injection of the contrast agent when the agent is predominately in the hepatic arteries and then again at 60 seconds after injection during the dominant portal venous phase.
Maltese: Għalhekk, sekwenza rapida ta' l-immaġni għandha tinbeda 20 sekonda wara injezzjoni bolus tas-sustanza tal-kuntrast meta s-sustanza tkun fil biċċa l-kbira tagħha fl-arterji epatiċi u mbagħad mill-ġdid, 60 sekonda wara l-injezzjoni waqt il-fażi venuża portali dominanti.
English: Each 20 ml syringe contains 6618 mg gadoversetamide.
Maltese: Kull siringa ta' 20 ml fiha 6618 mg ta' gadoversetamide.
English: 10 ml vials and 15 ml vials contain less than 1 mmol sodium; i.e. they are essentially ‘sodium free‘.
Maltese: Siringi ta' 10 ml u ta' 15 ml fihom anqas minn 1 mmol sodium, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: 30 ml (1, 10 syringes)
Maltese: 10 ml (1, 10 siringi) 15 ml (1, 10 siringi) 20 ml (1, 10 siringi) 30 ml (1, 10 siringi)
English: Optimark is contraindicated in these patients (see section Contraindications).
Maltese: Optimark huwa kontraindikat f'dawn ilpazjenti (ara sezzjoni Kontraindikazzjonijiet).
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute toxicity, reproductive toxicity, local tolerance, antigenicity, and genotoxicity.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, tossiċità akuta, effett tossiku fuq is-sistema riproduttiva, tolleranza lokali, antiġeneċità, u effett tossiku fuq il-ġeni, ma juri l ebda periklu speċjali għall-bnedmin.
English: To enable immediate action in emergencies, the necessary medicinal products (e.g. epinephrine/ adrenaline, theophylline, antihistamines, corticosteroids and atropines), endotracheal tube and ventilator must be immediately available.
Maltese: Biex tkun tista' tittieħed azzjoni immedjata f'emerġenzi, il-prodotti mediċinali meħtieġa (eż. epinephrine/adrenaline, theophylline, antistamini, kortikosterojdi u atropini), tubu endotrakeali u ventilatur għandhom ikunu disponibbli immedjatament.
English: Each 10 ml syringe contains 3309 mg gadoversetamide.
Maltese: Kull siringa ta' 10 ml fiha 3309 mg ta' gadoversetamide.
English: 1 x 20 ml 10 x 20 ml
Maltese: 10 x 20 ml
English: There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs).
Maltese: Kien hemm rapporti ta' fibrożi sistemika nefroġenika (li tikkawża ebusija tal-ġilda u tista' taffettwa wkoll it-tessut artab u l-organi interni).
English: ml/h/kg) and the two adult populations (82.1 ± 16.8 and 56.5 ± 9.7 ml/h/kg in the 19 to 64 and ≥ 65
Maltese: bejn 12 u 18-il sena (117 ± 26.1 ml/siegħa/kg) u ż-żewġ popolazzjonijiet adulti (82.1 ± 16.8 u
English: 1 x 30 ml 10 x 30 ml
Maltese: 10 x 30 ml
English: Cardiac Disorders
Maltese: Konfużjoni u disorjentament
English: Feeling hot
Maltese: Tqala u treddigħ
English: Pre-filled syringes:
Maltese: L-Effett tas-Sess:
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use CHMP.
Maltese: farmakovigilanza kif deskrit fil-Pjan ta' Farmakoviġilanza kif inhu maqbul fil-RMP ppreżentat f'Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti tal-RMP kif maqbul mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill
English: Acute toxicity symptoms are unlikely to occur in patients with normal renal function.
Maltese: tossiċità akuti mhumiex mistennija li jseħħu f'pazjenti b'funzjoni normali tal-kliewi.
English: Serious adverse reactions have been reported and include anaphylactic reactions, cardiovascular reactions, and allergic respiratory disorders.
Maltese: Reazzjonijiet avversi serji kienu rrappurtati u jinkludu reazzjonijiet anafilattiċi, reazzjonijiet kardjovaskulari u disturbi respiratorji allerġiċi.
English: Each 15 ml syringe contains 4963.5 mg gadoversetamide.
Maltese: Kull siringa ta' 15 ml fiha 4963.5 mg ta' gadoversetamide.
English: 30 ml of the solution contain 43.13 mg sodium.
Maltese: 20 ml tas-soluzzjoni fihom 28.75 mg sodium. 30 ml tas-soluzzjoni fihom 43.13 mg sodium.
English: 1 x 10 ml 10 x 10 ml
Maltese: 1 x 10 ml
English: • Hypersensitivity to gadoversetamide or to other gadolinium containing products or to any of the excipients.
Maltese: • Sensittività eċċessiva għal gadoversetamide jew għal prodotti oħra li fihom gadolinium jew għal kwalunkwe wieћed mill-eċċipjenti.
English: Vial 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Maltese: Kunjett 1 ml fih 330.9 mg ta' gadoversetamide, ekwivalenti għal 500 mikromol.
English: Nausea, Diarrhoea
Maltese: Dardir, Dijarea
English: The risk of hypersensitivity reactions is increased in the following cases: - patients with allergic predisposition - patients with bronchial asthma; in these patients it is especially the risk of bronchospasm which is increased - patients with a history of reactions to contrast agents, including a previous history of reaction to iodine-based contrast agents
Maltese: Ir-riskju ta' reazzjonijiet ta' sensittività eċċessiva jiżdied fil-każijiet li ġejjin: - pazjenti bi predispożizzjoni allerġika - pazjenti b'ażżma tal-bronki; f'dawn il-pazjenti, hu r-riskju ta' bronkospażmu li jiżdied b'mod partikulari;
English: What is in this leaflet:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Each 10 ml syringe contains 3309 mg gadoversetamide equivalent to 5 millimol.
Maltese: Kull siringa ta' 10 ml fiha 3309 mg ta' gadoversetamide, ekwivalenti għal 5 millimol.
English: Elderly (aged 65 years and above)
Maltese: Anzjani (li għandhom 65 sena jew iżjed)
English: Optimark must not be administered with an autoinjector to children of 2 to 11 years (see section 4.4).
Maltese: Optimark m'għandux jingħata b'awtoinjettatur lil tfal ta' minn sentejn sa 11-il sena (ara sezzjoni 4.4).
English: Optimark should only be used after careful risk/benefit evaluation in patients with moderate renal impairment (GFR 30-59 ml/min/1.73m2) at a dose not exceeding 100 micromol/kg body weight (see section 4.4).
Maltese: Optimark għandu jintuża biss wara evalwazzjoni bl-attenzjoni tar-riskju/benefiċċju f'pazjenti b'indeboliment moderat tal-kliewi (GFR 30-59 ml/min/1.73 m2) b'doża li ma taqbiżx 100 mikromol/kg ta' piż tal-ġisem (ara sezzjoni 4.4).
English: Lesion conspicuity of hypo- and hypervascular lesions may be reduced if imaging is delayed more than 3 minutes due to the diffusion of the contrast agent into the interstitial spaces of both the liver parenchyma and lesion (e.g. metastasis) making the lesion isointense with the normal liver parenchyma.
Maltese: Id-dehra tal-leżjonijiet ipo u ipervaskulari tista' titnaqqas jekk it-teħid ta' l-immaġni jiġi ttardjat b'iktar minn 3 minuti minħabba d-diffużjoni tas-sustanza tal-kuntrast fl-ispazji interstizjali kemm tal-parenchyma kif ukoll tal-leżjoni tal-fwied (eż. metastasi), u b'hekk il-leżjoni ssir isointensa mal-parenchyma normali tal-fwied.
English: Do not use this medicine after the expiry date which is stated on the carton and on the syringe label after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u fuq it-tikketta tas-siringa wara EXP.
English: The agent should be administered as a bolus peripheral intravenous injection.
Maltese: Metodu ta' kif għandu jingħata Il-mediċina għandha tingħata bħala injezzjoni bolus ġol-vini periferali.
English: Optimark 500 micromol/ml solution for injection in vial Gadoversetamide
Maltese: Optimark 500 mikromol/ml soluzzjoni għall-injezzjoni f'kunjett Gadoversetamide
English: Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period (see section 4.3).
Maltese: Optimark hu kontraindikat f'pazjenti b'indeboliment sever tal-kliewi (GFR < 30 ml/min/1.73 m2) u/jew ħsara akuta fil-kliewi u f'pazjenti li kellhom trapjant tal-fwied jew f'pazjenti fil-perjodu perioperattiv ta' trapjant tal-fwied (ara sezzjoni 4.3).
English: Optimark is contraindicated in neonates up to 4 weeks of age (see section 4.3).
Maltese: Optimark huwa kontraindikat f'dawn il pazjenti (ara sezzjoni 4.3).
English: Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73 m²) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period.
Maltese: Optimark hu kontraindikat f'pazjenti b'indeboliment sever tal-kliewi (GFR < 30 ml/min/1.73 m2) u/jew ħsara akuta fil-kliewi u f'pazjenti li kellhom trapjant tal-fwied jew f'pazjenti fil-perjodu perioperattiv ta' trapjant tal-fwied.
English: Optimark should only be used after careful risk/benefit evaluation in patients with moderate renal impairment (GFR 30-59 ml/min/1.73 m2) at a dose not exceeding 100 micromol/kg body weight.
Maltese: Optimark għandu jintuża biss wara evalwazzjoni bl-attenzjoni tar riskju/benefiċċju f'pazjenti b'indeboliment moderat tal-kliewi (GFR 30-59 ml/min/1.73 m2) b'doża li ma taqbiżx 100 mikromol/kg ta' piż tal-ġisem.
English: Allergoid and other idiosyncratic reactions also may occur with gadoversetamide, which could become manifest in form of cardiovascular, respiratory and skin reactions (see section 4.8).
Maltese: Sensittività eċċessiva Reazzjonijiet allerġojdi u reazzjonijiet idjosinkratiċi oħrajn jistgħu jseħħu wkoll b'gadoversetamide, li jistgħu jidhru taħt is-sura ta' reazzjonijiet kardjovaskulari, respiratorji u tal-ġilda (ara sezzjoni 4.8).
English: Caution should be exercised because transient decreases in serum iron and zinc parameters have been observed in clinical trials.
Maltese: Għandha tingħata attenzjoni minħabba li tnaqqis li jgħaddi malajr fil-parametri ta' l-iron u taż-zinc fisserum kien osservat fi provi kliniċi.
English: The usual dose of 0.2 ml/kg body weight is the same in adults and children of 2 years and older.
Maltese: Id-doża normali ta' 0.2 ml/kg ta' piż tal-ġisem hi l-istess fl-adulti u tfal li għandhom sentejn u aktar.
English: Pre-filled syringe 1 x 10 ml: EU/1/07/398/007 10 x 10 ml: EU/1/07/398/008 1 x 15 ml: EU/1/07/398/009 10 x 15 ml: EU/1/07/398/010 1 x 20 ml: EU/1/07/398/011 10 x 20 ml: EU/1/07/398/012
Maltese: 1 x 10 ml: EU/1/07/398/007 10 x 10 ml: EU/1/07/398/008 1 x 15 ml: EU/1/07/398/009 10 x 15 ml: EU/1/07/398/010 1 x 20 ml: EU/1/07/398/011
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Text for the outer packaging of 10 ml, 15 ml and 20 ml vials
Maltese: Kliem għal fuq il-pakkett ta' barra tas-siringi mimlijin għal-lest ta' 10 ml, 15 ml, 20 ml u 30 ml
English: The risk for development of NSF in patients with moderate renal impairment (GFR 30-59 ml/min/1.73 m²) is unknown; therefore Optimark should only be used after careful risk-benefit evaluation in patients with moderate renal impairment.
Maltese: Ir-riskju għall-iżvilupp ta' NSF f'pazjenti b'indeboliment moderat tal-kliewi (GFR 30-59 ml/min/1.73 m²) mhuwiex magħruf, u għalhekk Optimark għandu jintuża biss wara evalwazzjoni bl-attenzjoni tar-riskju/benefiċċju f'pazjenti b'indeboliment moderat tal-kliewi.
English: The majority of adverse reactions observed after the use of gadoversetamide were found to be adverse reactions of the nervous system, followed by general adverse reactions, gastrointestinal disorders/skin and subcutaneous tissue disorders.
Maltese: Il-maġġoranza tar-reazzjonijiet avversi li kienu osservati wara l-użu ta' gadoversetamide instabu li kienu reazzjonijiet avversi tas-sistema nervuża, segwiti minn reazzjonijiet avversi ġenerali, disturbi gastro-intestinali/disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda.
English: In cranial MRI, if a strong clinical suspicion of a lesion persists despite a single dose contrastenhanced MRI or when more accurate information on the number, size or extent of lesions might influence management or therapy of the patient, in subjects with normal renal function, a second bolus injection of 0.2ml/kg (100 micromol/kg) may be administered within 30 minutes of the first injection as it may increase the diagnostic yield of the examination.
Maltese: F'MRI kranjali, jekk jippersisti suspett kliniku qawwi ta' leżjoni, minkejja doża waħda ta' MRI bilkuntrast imtejjeb, jew fejn informazzjoni aktar preċiża dwar in-numru, id-daqs jew il-firxa tal leżjonijiet tista' tinfluwenza l-immanniġġjar jew it-terapija tal-pazjent, f'persuni b'funzjoni normali tal-kliewi, tista' tingħata t-tieni injezzjoni bolus ta' 0.2 ml/kg (100 mikromol/kg) sa 30 minuta millewwel injezzjoni peress li dan jista' jtejjeb ir-riżultat dijanjostiku ta' l-eżami.
English: Still, after 72 hours even in patients with severe renal impairment nearly the whole dose is recovered in the urine and in healthy populations up to 500 micromol/kg doses were administered without safety issues.
Maltese: Madankollu, xorta waħda wara 72 siegħa, anke f'pazjenti b'indeboliment serju tal-kliewi, kważi d-doża kollha tkun irkuprata fl-awrina, u f'popolazzjonijiet f'saħħithom ingħataw dożi sa 500 mikromol/kg mingħajr ma kien hemm problemi ta' sigurtà.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad
English: Prior to the launch, the MAA shall provide to all potential prescribers a copy of the SPC with a cover letter highlighting the safety information included in Sections 4.3 and 4.4.
Maltese: Qabel jitpoġġa fuq is-suq, l-MAA għandu jipprovdi kopja tas-Sommarju tal-Karatteristiċi tal-Prodott lil dawk kollha li potenzjalment jistgħu jagħtu riċetta għal din il-mediċina, b'ittra li tenfasizza linformazzjoni tas-sigurtà inkluża f'sezzjonijiet 4.3 u 4.4.
English: Blood creatinine increased, Haematuria
Maltese: Żieda fil-kreatinina tad-demm, Ematurja
English: Each 10 ml vial contains 3309 mg gadoversetamide.
Maltese: Kull kunjett ta' 10 ml fih 3309 mg ta' gadoversetamide.
English: Pre-filled syringe
Maltese: TAL-PRODOTT MEDIĊINALI
English: If you think you have been injected with too much Optimark, tell the doctor or nurse/technologist immediately.
Maltese: Jekk taħseb li kien injettat wisq Optimark, għid lit-tabib jew lin-ners/teknoloġista immedjatament.
English: In general, the addition of contrast to MRI, at the standard clinical dose of 100 micromol/kg, has led to a significantly improved lesion detection, sensitivity and diagnostic accuracy.
Maltese: B'mod ġenerali, iż-żieda tal-kuntrast mal-MRI, fid-doża klinika standard ta' 100 mikromol/kg, wasslet għal titjib sinifikanti fl osservazzjoni tal-leżjonijiet, fis-sensittività u fil-preċiżjoni dijanjostika.
English: Cases of gadolinium associated skin plaques, with demonstrated sclerotic bodies on histology, have been reported with some gadolinium-containing contrast agents in patients who do not otherwise have symptoms or signs of nephrogenic systemic fibrosis.
Maltese: Każijiet ta' plakek tal-ġilda assoċjati ma' gadolinium, b'korpi sklerotiċi li ntwerew fl-istoloġija, ġew irrappurtati b'xi aġenti tal-kuntrast li kien fihom gadolinium f'pazjenti li ma jkollhomx sintomi jew sinjali ta' fibrożi sistemika nefroġenika b'xi mod ieħor.
English: No formal interaction studies have been performed.
Maltese: Ma twettaq l-ebda studju formali ta' interazzjoni.
English: The risk for development of NSF in patients with moderate renal impairment (GFR 30-59 ml/min/1.73 m2) is unknown; therefore, Optimark should only be used after careful risk-benefit evaluation in patients with moderate renal impairment.
Maltese: Ir-riskju għall-iżvilupp ta' NSF f'pazjenti b'indeboliment moderat tal-kliewi (GFR 30-59 ml/min/1.73 m2) mhuwiex magħruf; u għalhekk Optimark għandu jintuża biss wara evalwazzjoni bl-attenzjoni tar-riskju/benefiċċju f'pazjenti b'indeboliment moderat tal-kliewi.
English: Each 10 ml vial contains 3309 mg gadoversetamide equivalent to 5 millimol.
Maltese: Kull kunjett ta' 10 ml fih 3309 mg ta' gadoversetamide, ekwivalenti għal 5 millimol.
English: In adults, a second dose may be given within 30 minutes of the first injection.
Maltese: Fl-adulti, tista' tingħata t-tieni doża fi żmien 30 minuta mill-ewwel injezzjoni.
English: hardening of the skin which may affect also soft tissue and internal organs (nephrogenic systemic fibrosis), feeling unwell
Maltese: ebusija tal-ġilda li tista' taffettwa wkoll lit-tessut artab u l-organi interni (fibrożi sistemika nefroġenika), tħossok ma tiflaħx
English: Gadoversetamide is used as a ‘contrast agent' in magnetic resonance imaging.
Maltese: Optimark għandu jinġibed ġos-siringa u jintuża immedjatament.
English: Nasal congestion, Throat irritation
Maltese: Disturbi fl-għajnejn
English: For liver metastases, the signal difference between the tumour and surrounding liver tissue is significantly improved during the first 90 seconds after an extracellular gadolinium contrast agent is administered.
Maltese: Għall-metastasi tal-fwied, id-differenza fis-sinjal bejn it-tumur u ttessut tal-madwar tal-fwied jitjieb b'mod sinifikanti matul l-ewwel 90 sekonda wara li tkun ingħatat is sustanza tal-kuntrast ta' gadolinium ekstraċellulari.
English: Erythema of eyelid, Eye pain, Vision blurred, Conjunctivitis,
Maltese: Nefħa madwar l-għajnejn, intraċċar anormali tal-qalb fuq ECG, ħass ħażin,
English: Because of the lack of information on repeated administration, Optimark injections should not be repeated unless the interval between injections is at least 7 days.
Maltese: L-injezzjonijiet ta' Optimark m'għandhomx jiġu ripetuti ħlief jekk l-intervall bejn l injezzjonijiet ikun ta' mill-inqas 7 ijiem.
English: A risk to the suckling child cannot be excluded.
Maltese: Ir-riskju gћat-trabi tat-twelid mhux eskluż.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in vial 15 ml
Maltese: Soluzzjoni għall-injezzjoni f'kunjett 15 ml
English: NSF may result in debilitating joint immobility, muscle weakness or may affect the normal working of internal organs which may potentially be life-threatening.
Maltese: NSF tista' tirriżulta f'immobilità li ddgħajjef il-ġogi, dgħjufija fil-muskoli jew tista' taffettwa l-operat normali ta' l-organi interni li potenzjalment jista' jkun ta' periklu għall-ħajja.
English: Limited data with other gadolinium contrast agents suggests that for the exclusion of additional cranial metastases in a patient with a known solitary resectable metastasis, an MR exam with the injection of the dose of 300 micromol/kg body weight of Optimark may lead to higher diagnostic confidence.
Maltese: Informazzjoni limitata dwar sustanzi oħrajn tal-kuntrast ta' gadolinium tissuġġerixxi li għallesklużjoni ta' metastasi kranjali addizzjonali f'pazjent b'metastasi solitarja magħrufa li tista' tinqata', eżami ta' MR b'injezzjoni tad-doża ta' 300 mikromol/kg piż tal-ġisem ta' Optimark, jista' jwassal għal kunfidenza dijanjostika ogħla.
English: Optimark is supplied in vials, fitted with bromobutyl rubber closures and aluminium cap seals.
Maltese: Optimark hu għal użu dijanjostiku biss.
English: Since the hepatic artery and portal venous system supply approximately 20% and 80% of the hepatic blood supply, respectively, the earlier (hepatic arterial phase) images provide optimal lesion conspicuity for hypervascular lesions and the portal venous phase images are useful for hypovascular lesions (most metastatic lesions are relatively hypovascular and are better demonstrated during the portal venous phase, manifesting as areas of lower signal intensity compared with the markedly enhanced liver).
Maltese: u 80% rispettivament tal-provvista tad-demm epatika, l-immaġni li jittieħdu iktar kmieni (fażi arterjali epatika) jipprovdu l-aħjar dehra tal-leżjonijiet ipervaskulari u l-immaġni tal-fażi venuża portali huma utli għal-leżjonijiet ipovaskulari (il-biċċa l-kbira tal-leżjonijiet metastatiċi huma relattivament ipovaskulari u jidhru aħjar waqt il-fażi venuża portali.
English: Hypersensitivity to gadoversetamide or to other gadolinium containing products, or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal gadoversetamide jew għal prodotti oħrajn li fihom gadolinium jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: • you suffer from epilepsy or brain lesions
Maltese: • tbati minn epilessija jew leżjonijiet fil-moħħ
English: The vials are fitted with bromobutyl rubber closures, aluminium cap seals, and plastic flip caps.
Maltese: tipproduċi figura baxxa żbaljata għall-calcium fil-plażma.
English: Clinical studies on fertility have not been performed.
Maltese: Ma sarux studji kliniċi dwar il-fertilità.
English: Haemodialysis shortly after Optimark administration may be useful at removing Optimark from the body.
Maltese: X'għandek tkun taf qabel ma tingħata Optimark Tużax Optimark jekk inti allerġiku
English: Renal and Urinary Disorders
Maltese: Disturbi fil-kliewi u fissistema urinarja
English: Inspect the syringe for signs of leakage.
Maltese: U INDIRIZZ TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: Prior to administration of Optimark, all patients should be screened for renal dysfunction by obtaining laboratory tests.
Maltese: Qabel l-għoti ta' Optimark, il-pazjenti kollha għandhom jiġu ċċekkjati għal disfunzjoni tal-kliewi billi jsirulhom testijiet tal-laboratorju.
English: Gadoversetamide plasma levels increase linearly with decreasing renal function; in patients with severe renal impairment (CrCl<30 ml/min) this even leads to a six-fold decreased gadoversetamide clearance and a corresponding six-fold increased extent of exposure AUC and t½.
Maltese: f'pazjenti b'indeboliment serju tal-kliewi (CrCl<30 ml/min) dan saħansitra jwassal għal tnaqqis ta' sitt darbiet fit-tneħħija ta' gadoversetamide u żieda korrispondenti ta' sitt darbiet fil-livell ta' espożizzjoni ta' l-AUC u t½.
English: Ear and Labyrinth Disorders
Maltese: Disturbi fil-widnejn u fissistema labirintika
English: Optimark 500 micromol/ml solution for injection in pre-filled syringe Gadoversetamide
Maltese: Optimark 500 mikromol/ml soluzzjoni għall-injezzjoni, f'siringa mimlija għal-lest
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: Pazjenti b'mard kardjovaskulari
English: No significant differences in pharmacokinetics based on gender were identified.
Maltese: Ma kienu identifikati l-ebda differenzi sinifikanti fil-farmakokinetiċi bbażati fuq is-sess.
English: 2, Aftokratoros Nikolaou str. 17671 Athens Greece
Maltese: Nikolaou str. 17671 Athens Greece
English: Alapis Romania SRL, Romania, Leordeni nr.13 Street, Bragadiru, IIfov County, 077025
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħataw, l-applikanti fl-istati membri
English: Levotiroxina Alapis
Maltese: Il-Greċja
English: Levothyroxine sodium
Maltese: Il-Belġju
English: The cumulative ketosis rate was 11.5% in the Kexxtone group compared with 25.6% in the placebo group.
Maltese: Ir-rata ta' ketożi kumulattiva kienet 11.5% fil-grupp ta' Kexxtone, meta mqabbel ma' 25.6% fil-grupp tal-plaċebo.