FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with Lutetium (177Lu) may cause tumour lysis syndrome, due to the rapid breakdown of tumour cells.
Maltese: Trattament b'Lutetium (177Lu) jista' jikkawża sindrome tal-liżi tat-tumur, minħabba t-tkissir rapidu ta' ċelluli tat-tumur.
English: The complete Summary of Product Characteristics (SmPC) of Lumark is provided as a separate document in the pack of the medicinal product, with the objective to provide healthcare professionals with other additional scientific and practical information about the use of this product.
Maltese: Is-Sommarju sħiħ tal-Karatteristiċi tal-Prodott (SmPC) ta' Lumark huwa pprovdut bħala dokument separat fil-pakkett tal-prodott mediċinali, bl-għan li jipprovdi lill-professjonisti tas-saħħa b'aktar informazzjoni xjentifika u prattika dwar l-użu ta' dan il-prodott.
English: Dry mouth has been reported among patients with prostate cancer receiving treatment with Lutetium (177Lu)
Maltese: Ħalq xott ġoe rapportat fost pazjenti b'kanċer tal-prostata li kienu qed jirċievu trattament b'Lutetium (177Lu)
English: Lumark is a type of product called a radiopharmaceutical precursor.
Maltese: Lumark huwa tip ta' prodott imsejjaħ prekursur radjufarmaċewtiku.
English: Lu)-chloride.
Maltese: U L-UŻU
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1. - Tqala stabbilita jew suspettata jew meta t-tqala ma tkunx ġiet eskluża (ara s-sezzjoni 4.6).
English: Hormone release syndromes:
Maltese: Mhux magħruf:
English: The presence of free Lutetium (177Lu) chloride in the body after an inadvertent administration of Lumark will lead to increased bone marrow toxicity and haematopoetic stem cell damage.
Maltese: Il-preżenza ta' klorur tal-Lutezju (177Lu) ħieles fil-ġisem wara għoti involontarju ta' Lumark sejra twassal għal żieda fit-tossiċità tal-mudullun u ħsara liċ-ċelloli stimali ematopojetiċi.
English: With respect to the distribution pattern in blood it appeared that 2 h after administration 15% of the Lutetium as being present in blood, had entered the blood cells with the remaining 85% still being present in the serum.
Maltese: Lutezju kien preżenti fid-demm, kien daħal fiċ-ċelloli tad-demm u l-85% l-ieħor kien għadu fis-serum.
English: If the administration is considered necessary, breastfeeding should be interrupted and the expressed feeds discarded.
Maltese: Jekk lamministrazzjoni tkun ikkunsidrata neċessarja, it-treddigħ għandu jitwaqqaf u l-alimentazzjoni espressa għandha tintrema.
English: Pancreas Red Marrow Osteogenic Cells Skin
Maltese: .8 Effetti mhux mixtieqa
English: Most of these events are mild and only temporary.
Maltese: Ħafna mill-każijiet kienu ħfief u temporanji.
English: What Lumark contains - The active substance is Lutetium (177Lu) chloride.
Maltese: Klorur tal-Lutezju (177Lu) DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: System Organ Class (MedDRA)
Maltese: Klassi tas-sistema ta' lOrgani (MedDra)
English: Osmolality (37°C): 1000 - 1200 mOsm/kg
Maltese: Osmolalità (37°C): 1000 - 1200 mOsm/kg
English: Final Study Report:
Maltese: Studju Finali Rapport:
English: Date of latest renewal: 15 June 2012
Maltese: Data tal-aħħar tiġdid: 15 ta' Ġunju 2012
English: Effects of Age:
Maltese: L-Effetti ta' l-Età:
English: Repeat dose
Maltese: Doża ripetuta
English: Nephrogenic systemic fibrosis (NSF)
Maltese: Fibrożi sistemika nefroġenika (NSF)
English: 15, rue des Vanesses 93420 Villepinte France
Maltese: 15, rue des Vanesses 93420
English: Calcium chloride dihydrate
Maltese: Calcium hydroxide Calcium chloride dihydrate
English: Optimark contains the active substance gadoversetamide.
Maltese: Optimark fih is-sustanza attiva gadoversetamide.
English: Contraindications
Maltese: Kontraindikazzjonijiet
English: Gadoversetamide is dialysable.
Maltese: Gadoversetamide hu dijalizabbli.
English: (≥1/100 to
Maltese: (≥1/1,000 sa
English: (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: (Ara Anness I: Sommarju tal- Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: Periorbital oedema
Maltese: Edema periorbitali
English: Cases of nephrogenic systemic fibrosis (NSF) have been reported with Optimark (see section 4.4).
Maltese: Każijiet ta' fibrożi sistemika nefroġenika (NSF) kienu rrappurtati b'Optimark (ara sezzjoni 4.4).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Guerbet, 15, rue des Vanesses, 93420 Villepinte, France
Maltese: Guerbet, 15, rue des Vanesses, 93420
English: • to the active substance gadoversetamide or
Maltese: • għas-sustanza attiva gadoversetamide jew
English: Serum iron and zinc
Maltese: Ħadid fis-serum u zinc
English: Gastrointestinal Disorders
Maltese: Disturbi gastro-intestinali
English: • to any of the other ingredients of Optimark (see section 6), or
Maltese: • għal xi sustanza oħra ta' Optimark (ara sezzjoni 6), jew
English: Gadoversetamide does not affect other methods of measuring serum calcium, such as the arsenazo III colorimetric method, atomic absorption spectroscopy, and inductively coupled plasma mass spectroscopy.
Maltese: Gadoversetamide ma jaffettwax metodi oħra ta' kejl tal-calcium fis serum, bħall-metodu kolorimetriku arsenazo III, l-ispettroskopija b'assorbiment atomiku, u linductively coupled plasma mass spectroscopy.
English: Ambulant patients while driving vehicles or operating machinery should take into account that acute dizziness may uncommonly (≥1/1,000 to <1/100) occur (see section 4.8).
Maltese: Pazjenti ambulanti waqt li jkunu qed isuqu l-vetturi jew iħaddmu l-makkinarju, għandhom jikkunsidraw li l-isturdament akut jista' jseħħ b'mod mhux komuni (≥1/1,000 sa <1/100) (ara sezzjoni 4.8).
English: • you are taking a special kind of antihypertensive medicine, i.e. a beta-blocker
Maltese: • qed tieħu tip speċjali ta' mediċina kontra l-pressjoni għolja, i.e. imblokkatur tar-riċetturi beta
English: Immune System Disorders
Maltese: Disturbi fis-sistema immuni
English: Central nervous system disorders
Maltese: Disturbi fis-sistema nervuza
English: Adult male and female subjects were enrolled in two pharmacokinetic studies.
Maltese: Irġiel u nisa adulti kienu rreġistrati f'żewġ studji farmakokinetiċi.
English: • in patients with severe renal impairment (GFR <30ml/min/1.73m2) and/or acute kidney injury,
Maltese: • f'pazjenti b'indeboliment sever tal-kliewi (GFR <30ml/min/1.73m2) u/jew ħsara akuta fil-kliewi,
English: At the 100 micromol/kg dose, the mean distribution half life in normal subjects calculated by the method of residuals in 12 normal volunteers is 13.3 ± 6.8 min.
Maltese: Fid-doża ta' 100 mikromol/kg, il-medja tal-half-life tad-distribuzzjoni f'persuni normali kkalkulata bil-metodu tar-residwi fi 12-il voluntier normali hi ta' 13.3 ± 6.8 min.
English: Gadoversetamide has been tested in humans in doses up to 700 micromol/kg (seven times the standard dose).
Maltese: Gadoversetamide kien ittestjat fil-bnedmin f'dożi sa massimu ta' 700 mikromol/kg (seba' darbiet iktar mid-doża standard).
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 July 2007
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23 ta' Lulju, 2007
English: 20 ml of the solution contain 28.75 mg sodium.
Maltese: 20 ml tas-soluzzjoni fihom 28.75 mg sodium.
English: Gadolinium containing MRI contrast agents (gadolinium-based chelates) are designed to act indirectly on the local magnetic environment by altering proton T1 (spin-lattice) and T2 (spin-spin) relaxation times and at the usual concentration of 100 micromol/kg, the T1 shortening predominates, and the T2 shortening is not significant using T1-weighted sequences.
Maltese: Sustanzi tal-kuntrast tal-MRI li fihom gadolinium (kelati bbażati fuq gadolinium) huma maħsuba biex jaġixxu indirettament fuq l-ambjent manjetiku lokali billi jibdlu l-ħinijiet tar-rilassament tal-proton T1 (spin-lattice) u T2 (spin-spin) u fil-konċentrazzjoni normali ta' 100 mikromol/kg, it-tnaqqis ta' T1 hu predominanti u t-tnaqqis tat-T2 mhuwiex sinifikanti bl-użu ta' sekwenzi weighted T1.
English: Patients with impaired renal function
Maltese: Pazjenti b'indeboliment fil-funzjoni renali
English: Mean volume of distribution at the 100 micromol/kg dose in non-renally impaired patients (including both normal subjects and patients with CNS or liver pathology) was 158.7 ± 29.0 to 214.3 (range 116.4 to 295.0) ml/kg.
Maltese: Il-medja tal-volum tad distribuzzjoni fid-doża ta' 100 mikromol/kg f'pazjenti mingħajr indeboliment fil-kliewi (inklużi kemm persuni normali kif ukoll pazjenti b'patoloġija fis-CNS jew fil-fwied) kienet ta' 158.7 ± 29.0 sa 214.3 (firxa minn 116.4 sa 295.0) ml/kg.
English: decreased appetite, feeling anxious, sleep disorder, drowsy feeling, burning sensation, a sensation of movement or spinning, ringing in the ears, eyelid redness, eye pain, vision blurred, bloodshot eyes, awareness of the heartbeat, irregular heartbeats, extra heartbeats, low blood pressure, shortness of breath, hoarseness, runny nose, throat constriction, mouth watering, abdominal pain, constipation, dry mouth, hives, cold sweat, redness, higher blood level of a substance (creatinine) usually eliminated by the kidneys, blood in urine, face swollen, weakness and similar symptoms like fatigue and general feeling of being unwell, fever, swelling in limbs, chill, pain, cold feeling in extremities, liver enzyme increased, urine analysis abnormal, mineral values in urine increased, protein in urine, heart and muscle enzyme increased, decreased haemoglobin, feeling confused and disoriented, shaking, convulsion, pink eye, fast heart beat, high blood pressure, tightening of the airways, swollen throat or voice box, raw throat, cough, itchy nose, sneezing, sweating
Maltese: (kreatinina) li normalment tkun eliminata mill-kliewi, demm fl-awrina, wiċċ minfuħ, dgħufija u sintomi simili bħal għeja kbira u sensazzjoni ġenerali li tħossok ma tiflaħx, deni, nefħa fid-dirgħajn/riġlejn, uġigħ, tkexkix ta' bard, sensazzjoni ta' kesħa fl-estremitajiet, żieda fl-enzimi fil-fwied, analiżi anormali ta' l-awrina, żieda fil-figuri tal-minerali fl-awrina, proteina fl-awrina, żieda fl enzimi fil-qalb u fil-muskoli, tnaqqis fl-emoglobina, tħossok konfuż u diżorjentat, rogħda, konvulżjoni, għajnejn roża, taħbit tal-qalb mgħaġel, pressjoni tad-demm għolja, il-passaġġi tan-nifs jidjiequ, gerżuma jew kordi vokali minfuħin, brix filgerżuma, sogħla, ħakk fl-imnieħer, għatis. għaraq
English: Decreased appetite
Maltese: Nuqqas t'aptit
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Maltese: Studji f'annimali ma urewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva.
English: Intravenous use.
Maltese: Mhux applikabbli.
English: Sodium hydroxide and/or hydrochloric acid for pH adjustment Water for injections
Maltese: Sodium hydroxide u/jew hydrochloric acid għal aġġustament tal-pH.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose of up to 17 ml, i.e. it is essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża ta' sa 17 ml, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: The usual dose
Maltese: Id-doża normali
English: Excipients: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/or hydrochloric acid, water for injections.
Maltese: Sustanzi mhux attivi: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide u/jew hydrochloric acid, ilma għall-injezzjonijiet.
English: Other medicines and Optimark
Maltese: Mediċini oħra u Optimark
English: 1 x 30 ml: EU/1/07/398/013 10 x 30 ml EU/1/07/398/014
Maltese: 10 x 30 ml EU/1/07/398/014
English: Chemical and physical in-use stability has been demonstrated for 24 hours at up to 25°C.
Maltese: L-istabbiltà kimika u dik fiżika waqt l-użu intweriet għal 24 siegħa f'temperaturi ta', u sa, 25°C.
English: However, there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).
Maltese: Madankollu, m'hemm l-ebda evidenza li l-emodijalisi hi adattata għall prevenzjoni ta' fibrożi sistemika nefroġenika (NSF).
English: There was no systematic difference in any of the kinetic parameters as a function of dose level (100 to 700 micromol/kg).
Maltese: Ma kien hemm ebda differenza sistematika fl-ebda wieħed mill-parametri kinetiċi bħala funzjoni tallivell tad-doża (100 sa 700 mikromol/kg).
English: Pharmacotherapeutic Group: MRI contrast media, ATC code: V08CA06
Maltese: Mezz tal-kuntrast MRI, Kodici ATC:
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini (EMA) http://www.ema.europa.eu/.
English: Most of the side effects observed after the use of Optimark were of mild to moderate intensity and transient in nature.
Maltese: Il-biċċa l-kbira tal-effetti sekondarji wara l-użu ta' Optimark kienu ta' intensità ħafifa sa moderata u ta' natura temporanja.
English: Rhinorrhoea, Throat tightness, Laryngeal/pharyngeal oedema, Pharyngitis, Rhinitis, Sneezing
Maltese: likwidu mill-imnieħer, Dwejjaq fil-gerżuma, Bronkospażmu, Sogħla, Edema talfarinġi/larinġi, Farinġite, Rinite, Għatis
English: Headache, Dysgeusia
Maltese: Villepinte, Franza
English: Breast-feeding should be discontinued for at least 24 hours after the administration of Optimark.
Maltese: It-treddigħ għandu jitwaqqaf għal mill-inqas 24 siegħa wara li tirċievi Optimark.
English: Each 30 ml syringe contains 9927 mg gadoversetamide.
Maltese: Kull siringa ta' 30 ml fiha 9927 mg ta' gadoversetamide.
English: The elimination half life at the 100 micromol/kg dose ranges from 1.49 ± 0.15 h in healthy volunteers to 2.11 ± 0.62 h in non-renally impaired patients (including normal subjects and patients with CNS or liver pathology).
Maltese: Eliminazzjoni Il-half-life tat-tneħħija fid-doża ta' 100 mikromol/kg tvarja bejn 1.49 ± 0.15 ta' siegħa f'voluntiera b'saħħithom sa 2.11 ± 0.62 ta' siegħa f'pazjenti mingħajr indeboliment tal-kliewi (inklużi kemm persuni normali kif ukoll pazjenti b'patoloġija fis-CNS jew fil-fwied).
English: Metabolism and Nutrition Disorders
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni
English: ALT increased, Urine analysis abnormal, Urine electrolytes abnormal, albumin in urine, CPK Increased, Haemoglobin
Maltese: Żieda fl-ALT, Analiżi anormali ta' l-awrina, Elettroliti anormali fl-awrina, albumina fl-awrina, Żieda fis-CPK, Tnaqqis flemoglobina
English: Optimark is contraindicated
Maltese: Optimark hu kontra-indikat
English: Each 20 ml syringe contains 6618 mg gadoversetamide equivalent to 10 millimol.
Maltese: Kull siringa ta' 20 ml fiha 6618 mg ta' gadoversetamide, ekwivalenti għal 10 millimol.
English: The agent should be administered as a bolus peripheral intravenous injection at a dose of 0.2 ml/kg (100 micromol/kg) body weight.
Maltese: Is-sustanza għandha tingħata bħala injezzjoni ġol-vina periferali bolus f'doża ta' 0.2 ml/kg (100 mikromol/kg) ta' piż tal-ġisem.
English: • you suffer from allergies (e.g. medicinal products, seafood, hay fever, hives) or asthma
Maltese: • tbati minn allerġiji (eż. prodotti mediċinali, frott tal-baħar, hay fever, urtikarja) jew ażżma
English: Insertion of a flexible in-dwelling venous catheter is recommended, see section 4.4.
Maltese: L-inserzjoni ta' kateter venuż in-dwelling flessibbli hu rakkomandat, ara sezzjoni 4.4.
English: The mean plasma clearance of gadoversetamide in healthy subjects (111.0 ± 14.1 ml/min/1.73m² BSA) is not significantly different from the mean renal clearance.
Maltese: (111.0 ± 14.1 ml/min/1.73m² BSA) mhijiex differenti b'mod sinifikanti mill-medja tat-tneħħija mill kliewi.
English: < 30ml/min/1.73 m2) and/or acute kidney injury, in
Maltese: GFR < 30 ml/min/1.73 m2), u/jew ħsara akuta fil-kliewi, f'
English: Optimark has been studied in children of 2 years and older with a similar safety profile as shown in the adult population.
Maltese: Optimark ġie studjat fi tfal ta' sentejn u akbar bi profil tas-sigurtà simili kif muri fil-popolazzjoni adulta.
English: Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver.
Maltese: Optimark hu indikat għall-użu ma' l-istrument ta' l-immaġni bir-riżonanza manjetika (MRI) tassistema nervuża ċentrali (CNS) u l-fwied.
English: Gadoversetamide does not undergo protein binding in vitro.
Maltese: Gadoversetamide ma jgħaddix minn fażi ta' twaħħil mal-proteini in vitro.
English: Gadoversetamide has been shown to cause interference in the measurement of serum calcium using the ortho-cresolphthalein complexone (OCP) colorimetric method.
Maltese: Intwera li Gadoversetamide jikkawża interferenza fil-kejl tal-calcium fis-serum bl-użu tal-metodu kolorimetriku ortho-cresolphthalein complexone (OCP). Madankollu, l-għoti ta' gadoversetamide ma jikkawżax tnaqqis veru tal-calcium fis-serum.
English: When the BBB is disrupted, the gadoversetamide molecules diffuse into the interstitial compartment thereby producing the characteristic paramagnetic effect of T1 and T2 shortening.
Maltese: Meta l-BBB ikun interrott, il-molekuli ta' gadoversetamide jinxterdu fil-kompartiment interstizjali u b'hekk jipproduċu l-effett paramanjetiku karatteristiku tat-taqsir ta' T1 u T2.
English: There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of Optimark and some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR <30ml/min/1.73m2) and/or acute kidney injury.
Maltese: Kien hemm rapporti ta' fibrożi sistemika nefroġenika (NSF) assoċjata ma' l-użu ta' Optimark u xi sustanzi tal-kuntrast li fihom gadolinium f'pazjenti b'indeboliment sever tal-kliewi akut jew kroniku (GFR <30ml/min/1.
English: • The other ingredients are: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/or hydrochloric acid, water for injections.
Maltese: • Is-sustanzi l-oħra huma: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide u/jew hydrochloric acid, ilma għall-injezzjonijiet.
English: Each 30 ml syringe contains 9927 mg gadoversetamide equivalent to 15 millimol.
Maltese: Kull siringa ta' 30 ml fiha 9927 mg ta' gadoversetamide, ekwivalenti għal 15 millimol.
English: Optimark contains sodium
Maltese: Optimark fih is-sodium
English: Uncommon (≥1/1,000
Maltese: Komuni (≥1/100 sa <1/10)
English: To ensure complete injection of the contrast medium, the injection should be followed by a 5 ml flush of sodium chloride 9 mg/ml (0.9 %) solution for injection.
Maltese: Biex tkun żgurata l-injezzjoni sħiħa tal-mezz tal-kuntrast, l-injezzjoni għandha tiġi segwita minn flush ta' 5 ml ta' sodium chloride 9 mg/ml (0.9 %) soluzzjoni għall-injezzjoni.
English: allergic/hypersensitivity reaction, dizziness, tingling sensation, numbness, reduced sense of smell, skin red and warm, nasal congestion, sore throat, nausea, diarrhoea, itching, rash, chest discomfort, chest pain, feeling cold including cold feeling in extremities, administration site reactions, changes in blood calcium levels
Maltese: reazzjoni allerġika/sensittività eċċessiva, sturdament, sensazzjoni ta' tingiż, tnemnim, sens tax-xamm imnaqqas, il-ġilda tkun ħamra u taħraq, konġestjoni nażali, uġigħ fil-griżmejn, dardir, dijarea, ħakk, raxx, skonfort fis-sider, uġigħ fis sider, tħoss il-bard inkluż sensazzjoni ta' bard fl-estremitajiet, reazzjonijiet fis-sit ta' l-għoti, bidliet fil-livelli tal-kalċju fid-demm
English: The elimination half life in the 2 to 11 and 12 to 18 year age groups (1.4 ± 0.3 and 1.6± 0.3 h-1, respectively) is shorter than that observed in the two adult populations (1.9 ± 0.5 and 2.5± 0.5 h-1 in the 19 to 64 and ≥ 65 year of age groups, respectively).
Maltese: (1.9 ± 0.5 u 2.5 ± 0.5 siegħa-1 fil-gruppi ta' età ta' 19 sa 64 sena u ta' ≥ 65 sena, rispettivament).
English: This volume of distribution (approximately 10-15 l for a body weight of 70 kg) is consistent with a medicinal product which distributes into the extracellular fluid.
Maltese: Dan il-volum ta' distribuzzjoni (madwar 10-15 l għal piż tal-ġisem ta' 70 kg) hu konsistenti ma' prodott mediċinali li jiddistribwixxi fil-fluwidu ekstraċellulari.
English: Each 20 ml vial contains 6618 mg gadoversetamide equivalent to 10 millimol.
Maltese: Kull kunjett ta' 20 ml fih 6618 mg ta' gadoversetamide, ekwivalenti għal 10 millimol.
English: Optimark pre-filled syringes are supplied in the following package sizes: 1 x 10 ml 10 x 10 ml
Maltese: Il-kunjetti Optimark huma fornuti fid-daqsijiet tal-pakkett li ġejjin: 1 x 10 ml
English: Psychiatric Disorders
Maltese: Disturbi psikjatriċi
English: The MAH shall submit annual cumulative reviews on nephrogenic systemic fibrosis (NSF) cases.
Maltese: L-MAH għandu jissottometti reviżjonijiet kumulattivi annwali dwar każijiet ta' fibrożi sistemika nefronġenika (NSF).
English: Each 15 ml syringe contains 4963.5 mg gadoversetamide equivalent to 7.5 millimol.
Maltese: Kull kunjett ta' 15 ml fih 4963.5 mg ta' gadoversetamide, ekwivalenti għal 7.5 millimol.
English: Optimark has been shown to cause interference in the measurement of serum calcium using the orthocresolphthalein complexone (OCP) colorimetric method.
Maltese: Intwera li Optimark jikkawża interferenza fil-kejl tal-calcium fis-serum bl-użu tal-metodu kolorimetriku ortho-cresolphthalein complexone (OCP). Madankollu, l-għoti ta' gadoversetamide ma jikkawżax tnaqqis veru tal-calcium fis-serum.
English: • Optimark is contraindicated in patients with severe renal impairment (GFR
Maltese: • Optimark huwa kontraindikat fuq pazjenti b'indeboliment renali sever
English: Dizziness,
Maltese: TA' EĊĊIPJENTI
English: 1 x 10 ml 10 x 10 ml 1 x 15 ml 10 x 15 ml 1 x 20 ml 10 x 20 ml
Maltese: Soluzzjoni għall-injezzjoni f'kunjett 10 ml (1, 10 kunjetti) 15 ml (1, 10 kunjetti) 20 ml (1, 10 kunjetti
English: 1 x 15 ml 10 x 15 ml
Maltese: 1 x 15 ml
English: 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Maltese: 1 ml fih 330.9 mg ta' gadoversetamide, ekwivalenti għal 500 mikromol.
English: Vascular Disorders
Maltese: Disturbi vaskulari
English: The enhancement of brain tumours using a gadolinium (or iodine) containing contrast agent depends on the disruption of the blood brain barrier (BBB).
Maltese: It-titjib ta' l-osservazzjoni ta' tumuri tal-moħħ bl-użu ta' sustanza tal-kuntrast li fiha gadolinium (jew iodine) tiddependi fuq l-interruzzjoni tal-barriera tad-demm fil-moħħ (blood brain barrier - BBB).
English: Weekly repeated dosing of two to twenty times the clinical dose from one week of age through maturation resulted in extensive mineralization of tissues, which produced localized effects, such as ulcerative dermatitis, compromised circulation and hepatic dysfunction.
Maltese: Dożaġġ ripetut kull ġimgħa ta' minn tnejn sa għoxrin darba tad-doża klinika sa mill-età ta' ġimgħa sal-maturazzjoni, irriżulta f'mineralizzazzjonii estensiva tat-tessut, li pproduċiet effetti lokalizzati, bħal dermatite ulċerattiva, ċirkolazzjoni kompromessa u disfunzjoni tal-fwied.
English: The pharmacokinetics of gadoversetamide conforms to a two compartment open-model.
Maltese: Il-farmakokinetiċi ta' gadoversetamide huma konformi ma' mudell miftuħ b'żewġ kompartimenti.
English: Palpitations, AV block first Tachycardia, Arrhythmia
Maltese: Palpitazzjonijiet, Imbokk AV ta' l-ewwel grad, Extrasystoles, Takikardija, Arritmija
English: Gadoversetamide, an extracellular gadolinium chelate, after intravenous administration, equilibrates rapidly within the extracellular fluid/space and is eliminated primarily by glomerular filtration.
Maltese: Gadoversetamide, bħala kelat ekstraċellulari ta' gadolinium, wara li jingħata ġol-vina, isir ekwilibrat malajr fil-fluwidu/spazju ekstraċellulari u jitneħħa primarjament permezz tal-filtrazzjoni glomerulari.
English: Optimark vials are supplied in the following package sizes: 1 x 10 ml 10 x 10 ml
Maltese: Daqsijiet tal-pakketti: 1 x 10 ml