qanastek/EMEA-V3 huggingface dataset:
12  Renal impairment and liver transplant patients There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with severe renal impairment (GFR < 30ml/ min/ 1.73m2) and those who have had or are undergoing liver transplantation.
Il- prekawzjonijiet huma meħtieġa meta jiġu eżaminati dawn il- pazjenti (eż. monitoraġġ tal- pazjent) u t- tagħmir u l- prodotti mediċinali meħtieġa għall- kura fil- pront ta ’ konvulżjonijiet possibbli għandhom ikunu disponibbli.  Indeboliment tal- kliewi u pazjenti li jkollhom trapjant tal- fwied Kien hemm rapporti ta ’ fibrożi sistemika nefroġenika (NSF) assoċjata ma ’ l- użu ta ’ xi sustanzi tal - kuntrast li fihom gadolinium f’ pazjenti b’ indeboliment sever tal- kliewi (GFR < 30ml/ min/ 1. 73m2) u dawk li kellhom, jew li bħalissa għaddejjin minn trapjant tal- fwied.
There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.  Children Optimark must not be administered with an autoinjector.
M' hemm l- ebda evidenza li tappoġġja l- bidu ta 'l- emodijalisi għall- prevenzjoni jew il- kura ta' NSF f' pazjenti li mhux qegħdin diġà fuq l- emodijalisi.  Tfal Optimark m’ għandux jingħata permezz ta ’ awto- injettatur.
The required dose should be administered by hand to children to avoid overdosage by mistake.  Neonates and infants Optimark should not be used in children below the age of two years.
Id- doża meħtieġa għandha tingħata lit- tfal bl- idejn biex ikun evitat l- għoti ta ’ doża eċċessiva bi żball.  Trabi tat- twelid żgħar Optimark m’ għandux jintuża fi tfal li għandhom inqas minn sentejn.
The degree of excretion of gadoversetamide in breast milk has not been studied in humans.
14 Il- livell ta ’ tneħħija ta ’ gadoversetamide fil- ħalib tas- sider ma kienx studjat fil- bniedem.
13 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
System Organ
Rari Ħafna
Rare
Rari ((≥1/ 10, 000,
Very Rare
Organi (MedDra)
< 1/ 100) Anaphylactic reaction
< 1/ 100)
Nutrition Disorders
Disturbi fis - sistema immuni Disturbi fil -
Decreased appetite
Reazzjoni anafilattika
Anxiety, Sleep
metaboliżmu u n - nutrizzjoni
Confusional state
Nuqqas t’ aptit
Disorders
Disturbi
disorder
Ansjetà, Problemi biex
Nervous System
Stat ta ’ konfużjoni
Dizziness,
psikjatriċi
Hypoaesthesia,
Sturdament, Uġigħ ta ’
Syncope, Tremor,
torqod
Disorders
Disturbi fis -
Eye Disorders
sistema nervuża
Eye pain, Vision blurred
Indeboliment fis- sens tat - togħma
Ocular hyperaemia
Parestesija, Parosmija
Ear and Labyrinth Tinnitus Disorders Tachycardia, Palpitations, AV block Cardiac Disorders
Ngħas, Sensazzjoni ta ’ ħruq Eritema ta ’ tebqet il -
Hypotension,
Konvulzjoni
Disorders Respiratory,
Disturbi fl - għajnejn Disturbi fil - widnejn u fis - sistema labirintika
Hypertension Dyspnoea, Dysphonia,
għajn, Uġigħ fl - għajnejn, Vista mċajpra Żarżir fil- widnejn Takikardja, Palpitazzjonijiet,
Thoracic and
Iperimija ta ’ l - għajnejn
Disorders
Disturbi fil- qalb
Disorders Skin and
Imbokk AV ta ’ l - ewwel grad, Extrasystoles
Diarrhoea
Arritmija
pain, Constipation, Dry mouth
15 Klassi tas -
14
Komuni
Uncommon
Rari Ħafna
System Organ
sistema ’ ta ’ l -
(≥ 1/ 10,000, < 1/ 1,000) Blood creatinine increased, Hematuria Pain, Chest pain, Face
< 1/ 1, 000) Pressjoni tad- demm
General Disorders
Disturbi vaskulari
Chest discomfort,
Disturbi
oedema, Fatigue,
Bronkospażmu,
and
nażali,
Feeling hot
Irritazzjoni fil - gerżuma
Feeling cold,
likwidu mill- imnieħer, Dwejjaq fil- gerżuma Żieda fil- produzzjoni
Fever, Oedema
Farinġite, Rinite, Għatis
Malaise, Feeling
Disturbi gastro - intestinali Disturbi fil- ġilda
Administration
Dardir, Dijarea
peripheral, Peripheral
Disturbi ġenerali
abnormal,
sider, Tħoss il -
Site Conditions
u kondizzjonijiet
coldness ALT increased, Urine analysis abnormal, Urine electrolytes
kbira, Deni, Edema
Investigations
Telqa, Ma tħossokx
abnormal CPK
sħana
Electrocardiogram
Reazzjonijiet fis - sit ta ’ l- għoti
Paramagnetic MRI contrast media, ATC code:
Kategorija farmakoterapewtikaMezz tal- kuntrast paramanjetiku MRI, Kodici ATC:
Gadoversetamide is a chelate containing gadolinium - which has paramagnetic properties and is responsible for the contrast enhancement effect in MRI - and the ligand versetamide.
16 Gadoversetamide hu kelat li fih gadolinium - li għandu proprjetajiet paramanjetiċi u hu responsabbli għall- effett tat- titjib tal- kuntrast fl- MRI – u l- ligand versetamide.
As a result of these characteristics, the timing of the image acquisition after contrast administration is critical in liver imaging.
Bħala riżultat ta ’ dawn il- karatteristiċi, il- ħin tal- kisba ta ’ l- immaġni wara l- għoti tal- mezz tal- kuntrast hu kritiku fl- immaġni tal- fwied.
For liver metastases, the signal difference between the tumour and surrounding liver tissue is significantly improved during the first 90 seconds after an extracellular
Għall- metastasi tal- fwied, id- differenza fis- sinjal bejn it- tumur u t - tessut tal- madwar tal- fwied jitjieb b’ mod sinifikanti matul l- ewwel 90 sekonda wara li tkun ingħatat is - sustanza tal- kuntrast ta ’ gadolinium ekstraċellulari.
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).
Dawn jidhru bħala żoni b’ intensità tas- sinjal iktar baxxa meta mqabbla mal- fwied li li jkun jidher aktar, b’ mod notevoli).
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.
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.
Delayed post-contrast or equilibrium images (> 5 minutes after dosing) assist in the characterization of lesions, e. g. the centre of a metastasis may accumulate contrast in the interstitial space of the lesion and become hyperintense to the normal liver.
It- teħid iktar tard ta ’ l- immaġni wara l- kuntrast jew l- ekwilibriju (> 5 minuti wara l- għoti tad - doża), jgħin fil- karatterizzazzjoni tal- leżjonijiet, eż. iċ- ċentru tal- metastasi jista ’ jakkumula l- kuntrast fl- ispazju interstizjali tal- leżjoni u jsir iperintensiv għall- fwied normali.
Elimination 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).
17 Tneħħija 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).
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.
Il- medja tat- tneħħija ta ’ gadoversetamide mill- plażma f’ persuni b’ saħħithom (111. 0 ± 14. 1 ml/ min/ 1. 73m² BSA) mhijiex differenti b’ mod sinifikanti mill- medja tat- tneħħija mill- kliewi.
Such results (ratio renal clearance/ total plasma clearance close to 1) indicate that gadoversetamide is essentially cleared through the kidneys.
Dawn ir- riżultati (proporzjon tat- tneħħija mill- kliewi/ tneħħija totali mill- plażma li jkun qrib ta ’ 1) jindikaw li gadoversetamide ikun essenzjalment imneħħi mill- kliewi.
16 Special Populations
Popolazzjonijiet Speċjali L- Effett tas- Sess:
When corrected for body weight, the total body clearance of gadoversetamide is greater in the 2 to 11 year age group (143 ± 27.9 ml/ h/ kg) than that observed in the 12 to 18 year age group (117 ± 26.1 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 year of age groups, respectively).
Meta tkun ikkoreġuta għall- piż tal- ġisem, it- tneħħija totali ta ’ gadoversetamide mill- ġisem hi akbar fil - grupp ta ’ età ta ’ bejn 2 u 11- il sena (143 ± 27. 9 ml/ siegħa/ kg) milli dik osservata fil- grupp ta ’ età ta ’ bejn 12 u 18- il sena (117 ± 26. 1 ml/ siegħa/ kg) u ż- żewġ popolazzjonijiet adulti (82. 1 ± 16. 8 u 56. 5 ± 9. 7 ml/ siegħa/ kg fil- gruppi ta ’ età ta ’ 19 sa 64 sena u ta ’ ≥ 65, rispettivament).
Repeated-dose toxicity studies in rats and dogs revealed vacuolation of the tubular cells of the kidneys, with strong evidence for reversibility of the effect.
18 Studji dwar it- tossiċità meta jingħataw dożi ripetuti fil- firien u fil- klieb, żvelaw il- vakwolazzjoni taċ - ċelluli tubulari tal- kliewi, b’ evidenza qawwija għar- riversibbiltà ta ’ l- effett.
17 From a microbiological point of view, the product should be used immediately.
Mill- aspett mikrobijoloġiku, il- prodott għandu jintuża immedjatament.
Optimark is filled in vials made of colourless highly resistant borosilicate glass (EP Type I).
Optimark hu mimli f' kunjetti magħmulin minn ħġieġ bla kulur tal- borosilicate (EP Tip I) li huma reżistenti ħafna.
The vials are fitted with bromobutyl rubber closures, aluminium cap seals, and plastic flip caps.
Il- kunjetti huma mgħammra b’ għatjien tal- lastku tal- bromobutyl, siġilli ta ’ l- għatu ta ’ l- aluminju, u għatjien tal- plastik li jinfetħu b’ daqqa ta ’ saba ’.
Optimark is also available in pre-filled syringes of 10 ml, 15 ml, 20 ml and 30 ml.
Optimark hu wkoll disponibbli f’ siringi mimlijin għal- lest ta ’ 10 ml, 15 ml, 20 ml u 30 ml.
6.6 Special precautions for disposal and other handling
19 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Optimark should be drawn into the syringe and used immediately.
Optimark għandu jinġibed ġos- siringa u jintuża immedjatament.
If frozen, presentations of gadoversetamide in glass containers may be warmed to room temperature and shaken vigorously.
Jekk iffriżat, il- preżentazzjonijiet ta ’ gadoversetamide fil- kontenituri tal- ħġieġ jistgħu jissaħħnu sat - temperatura tal- kamra u jiġu mċaqilqa bis- saħħa.
The product must be examined before use to confirm that all solids are dissolved and that the container and closure are undamaged.
Il- prodott irid ikun eżaminat qabel l- użu biex tikkonferma li s- solidi kollha jkunu nħallu u li l- kontenitur u l- għatu ma jkunx fihom ħsara.
If solids remain, the vial must be discarded.
Jekk ikun baqa ’ xi solidi, il- kunjett għandu jintrema.
Discard syringe and unused portion of the solution after use.
Armi s- siringa u l- porzjon tas- soluzzjoni mhux użat wara l- użu.
Covidien Deutschland GmbH Gewerbepark 1 93333 Neustadt/ Donau Germany
Covidien Deutschland GmbH Gewerbepark 1 93333 Neustadt/ Donau Il- Ġermanja
Mallinckrodt Medical Imaging Ireland Damastown Mulhuddart Dublin 15 Ireland
Mallinckrodt Medical Imaging Ireland Damastown Mulhuddart Dublin 15 L- Irlanda
(See Annex I:
Ara Anness I:
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.
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 l - informazzjoni tas- sigurtà inkluża f’ sezzjonijiet 4. 3 u 4. 4.
The text shall be agreed by the CHMP and shall also contain the following key element:
Il- kliem għandu jiġi maqbul mis- CHMP u għandu jkun fih ukoll l- element importanti li ġej:
 Optimark is not recommended for use in children below the age of two years because the safety, efficacy, and impact of immature kidney function have not been studied in this age group.
Optimark mhux irrakkomandat għall- użu fit- tfal ta ’ taħt l- età ta ’ sentejn minħabba li s- sigurtà, effikaċja u l- impatt ta ’ funzjoni immatura tal- kliewi ma kinitx studjata fil - grupp ta ’ din l- età.
Optimark has been studied in children of 2 years and older with a similar safety profile as shown in the adult population.
Optimark kien studjat fit- tfal ta ’ sentejn u akbar bi profil tas - sigurtà simili għal dak muri fil- popolazzjoni adulta.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2009/ 02 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza L- MAH irid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 2009/ 02, ippreżentata f’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun implimentata u taħdem qabel u waqt li l- prodott jkun qiegħed fuq is- suq
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version dated 22 May 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan dwar l- Immaniġġjar tar- Riskju L- MAH irid jikkommetti ruħu li jwettaq l- istudji u attivitajiet addizzjonali ta ’ farmakoviġilanza deskritti fil- Pjan tal- Farmakoviġilanza, kif maqbul fil- verżjoni bid- data tat- 22 ta ’ Mejju, 2007, tal- Pjan dwar l- Immaniġġjar tar- Riskju (RMP) ippreżentat f’ Modulu 1. 8. 2. ta ’ l- Applikazzjoni ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq, u kwalunkwe aġġornamenti sussegwenti tal- RMP li kienu maqbula mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida tas- CHPM dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskji għal prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jkun sottomess fl- istess ħin mar- Rapport Perjodiku dwar l - Aġġornament tas- Sigurtà (PSUR) li jkun imiss.
In addition, an updated RMP should be submitted  When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities  Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached  At the request of the EMEA
Flimkien ma ’ dan, RMP aġġornat għandu jkun sottomess  Meta informazzjoni ġdida tkun irċevuta li jista ’ jkollha jkollha impatt fuq l- Ispeċifazzjoni tas - Sigurtà kurrenti, fuq il- Pjan tal- Farmakoviġilanza jew fuq attivitajiet li jnaqqsu r- riskju.
Text for the outer packaging of 10 ml, 15 ml, 20 ml and 30 ml pre-filled syringes
Kliem għal fuq il- pakkett ta ’ barra tas- siringi mimlijin għal- lest ta ’ 10 ml, 15 ml, 20 ml u 30 ml
Optimark 500 micromol/ ml solution for injection in a pre-filled syringe Gadoversetamide
Optimark 500 mikromol/ ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Gadoversetamide
Excipients: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/ or hydrochloric acid, water for injections.
Sustanzi mhux attivi: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide u/ jew hydrochloric acid, ilma għall- injezzjonijiet.
Solution for injection 10 ml (1, 10 syringes) 15 ml (1, 10 syringes) 20 ml (1, 10 syringes) 30 ml (1, 10 syringes)
Soluzzjoni għall- injezzjoni 10 ml (1, 10 siringi) 15 ml (1, 10 siringi) 20 ml (1, 10 siringi) 30 ml (1, 10 siringi)
Contrast medium for magnetic resonance imaging
Medjum tal- kuntrast għall- immaġni bir- riżonanza manjetika
Discard any remaining solution after first use.
Armi kwalunkwe fdal tas- soluzzjoni wara l- ewwel użu.
Covidien Deutschland GmbH, Gewerbepark 1, 93333 Neustadt/ Donau, Germany
Covidien Deutschland GmbH, Gewerbepark 1, 93333 Neustadt/ Donau, il- Ġermanja
MARKETING AUTHORISATION NUMBER(S)
NUMRU (/ I) TA’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Subject to medical prescription.
Prodott mediċinali jingħata bir- riċetta tat- tabib.
Justification for not including Braille accepted
Il- Gustifikazzjoni biex ma jkunx inkluż il- Braille hija aċċetta
25 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
27 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Text for the immediate packaging of 15 ml, 20 ml and 30 ml pre-filled syringes
Kliem għal fuq il- pakkett li jmiss mal- prodott tas- siringi mimlijin għal- lest ta ’ 15 ml, 20 ml u 30 ml
Optimark 500 micromol/ ml solution for injection in a pre-filled syringe Gadoversetamide
Optimark 500 mikromol/ ml soluzzjoni għall- injezzjoni, f’ siringa mimlija għal- lest Gadoversetamide
Solution for injection 15 ml 20 ml 30 ml
Soluzzjoni għall- injezzjoni 15 ml 20 ml 30 ml
Text for the immediate packaging of the 10 ml pre-filled syringe
Kliem għal fuq il- pakkett li jmiss mal- prodott tas- siringi mimlija għal- lest ta ’ 10 ml
Optimark 500 micromol/ ml solution for injection in a pre-filled syringe Gadoversetamide IV use.
Optimark 500 mikromol/ ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Gadoversetamide Użu għal ġol- vini.
Text for the outer packaging of 10 ml, 15 ml and 20 ml vials
Kliem għal fuq il- pakkett ta ’ barra tal- kunjetti ta ’ 10 ml, 15 ml u 20 ml
Optimark 500 micromol/ ml solution for injection in a vial Gadoversetamide
Optimark 500 mikromol/ ml soluzzjoni għall- injezzjoni f’ kunjett Gadoversetamide
Solution for injection 10 ml (1, 10 vials) 15 ml (1, 10 vials) 20 ml (1, 10 vials)
Soluzzjoni għall- injezzjoni 10 ml (1, 10 kunjetti) 15 ml (1, 10 kunjetti) 20 ml (1, 10 kunjetti
30 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Text for the immediate packaging of 15 ml and 20 ml vials
Kliem għal fuq il- pakkett li jmiss mal- prodott tal- kunjetti ta ’ 15 ml u 20 ml
Excipients: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/ or hydrochloric acid, water for injections.
Sustanzi mhux attivi: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide / jew hydrochloric acid, ilma għall- injezzjonijiet.
Solution for injection 15 ml 20 ml
Soluzzjoni għall- injezzjoni 15 ml 20 ml
32 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
34 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Text for the immediate packaging of the 10 ml vial
Kliem għal fuq il- pakkett li jmiss mal- prodott tal- kunjett ta ’ 10 ml
Optimark 500 micromol/ ml solution for injection in a vial Gadoversetamide IV use.
Optimark 500 mikromol/ ml soluzzjoni għall- injezzjoni f’ kunjett Gadoversetamide Użu għal ġol- vini.
Keep the vial in the outer carton in order to protect from light.
Żomm il- kunjett fil- kartuna ta ’ barra biex tipproteġiha mid- dawl.
34 PACKAGE LEAFLET:
36 FULJETT TA ’ TAGĦRIF:
Read all of this leaflet carefully before you are being given this medicine.
Aqra sew dan il- fuljett kollu qabel ma tingħata din il- mediċina.
What Optimark is and what it is used for 2.
X’ inhu Optimark u għalxiex jintuża 2.
Before you are given Optimark 3.
Qabel ma tingħata Optimark 3.
How Optimark is given 4.
Kif jingħata Optimark 4.
How to store Optimark 6.
Kif taħżen Optimark 6.
WHAT Optimark IS AND WHAT IT IS USED FOR
X’ INHU Optimark U GĦALXIEX JINTUŻA 1.
Optimark is an injectable contrast medium.
Optimark hu mezz tal- kuntrast li jista ’ jiġi injettat.
It is used to make clearer diagnostic images of the brain, spine and of the liver, in adults and children.
Jintuża biex jagħmel l- immaġni dijanjostiċi tal - moħħ, tas- sinsla tad- dahar u tal- fwied, fl- adulti u fit- tfal, iktar ċari.
As a result, it helps to clearly show abnormalities in the brain and spine, and in the liver.
Bħal riżultat, dan jgħin biex juri l - anormalitajiet b’ mod ċar fil- moħħ u fis- sinsla tad- dahar, u fil- fwied.
BEFORE YOU ARE GIVEN Optimark
QABEL MA TINGĦATA Optimark
Do not use Optimark if you are allergic (hypersensitive)  to the active substance gadoversetamide or  to any of the other ingredients of Optimark, or  to other gadolinium contrast agents
Tużax Optimark jekk inti allerġiku/ a (tbati minn sensittività eċċessiva)  għas- sustanza attiva gadoversetamide jew  għal xi sustanza oħra ta ’ Optimark, jew  għal sustanzi oħrajn ta ’ sustanzi tal- kuntrast ta ’ gadolinium
You should not be given Optimark if you suffer from severe kidney impairment, or if you are a liver transplant patient as use of Optimark in patients with these conditions has been associated with a disease called Nephrogenic Systemic fibrosis (NSF).
M’ għandekx tingħata Optimark jekk tbati minn indeboliment sever tal- kliewi, jew jekk inti pazjent/ a li kellek trapjant tal- fwied, għax l- użu ta ’ Optimark f’ pazjenti b’ dawn il- kundizzjonijiet kien assoċjat ma ’ marda msejħa Fibrożi Sistemika Nefroġenika (NSF).
NSF is a disease involving thickening of the skin and connective tissues.
NSF hi marda li tinvolvi li l- ġilda u t- tessut konnettiv jeħxienu.
NSF may result in debilitating joint immobility, muscle weakness or impairment of the function of internal organs which may potentially be life threatening.
NSF tista ’ tirriżulta f’ immobilità li ddgħajjef il- ġogi, dgħjufija fil- muskoli jew indeboliment tal- funzjoni ta ’ l- organi interni li potenzjalment jista ’ jkun ta ’ periklu għall- ħajja.
Take special care with Optimark Diagnostic procedures involving the use of contrast agents should be conducted under supervision of a physician with the prerequisite training and a thorough knowledge of the procedure to be performed.
Oqgħod attent ħafna b’ Optimark Proċeduri dijanjostiċi li jinvolvu l- użu ta ’ sustanzi tal- kuntrast għandhom jitwettqu taħt is- sorveljanza ta ’ tabib li jkollu t- taħriġ prerekwiżit u għarfien komprensiv tal- proċedura li tkun ser titwettaq.
Tell your doctor, if:  you suffer from allergies (e. g. medicinal products, seafood, hay fever, hives) or asthma  you had any reactions to previous injections of a contrast agent, including a previous history of reaction to iodine-based contrast agents  your kidneys do not work properly  Optimark is planned to be used in your child which is below the age of two years
Għid lit- tabib tiegħek, jekk:  tbati minn allerġiji (eż. prodotti mediċinali, frott tal- baħar, hay fever, urtikarja) jew ażżma  kellek xi reazzjonijiet għal injezzjonijiet ta ’ sustanza tal- kuntrast fil- passat, li tinkludi passat mediku ta ’ reazzjoni għal sustanzi tal- kuntrast ibbażati fuq l- iodine  il- kliewi tiegħek ma jiffunzjonawx tajjeb  Optimark hu ppjanat li jintuża fit- tifel/ tifla tiegħek li għandu/ għandha inqas minn sentejn
35 Tell your doctor, if:  you are feeling thirsty and/ or if you have only had small quantities or nothing to drink before the examination  you have a cardiac pacemaker or any ferromagnetic implant (vascular clips, etc.) or a metallic stent in your body  you are taking a special kind of antihypertensive medicine, i. e. a beta-blocker  you have heart disease  you suffer from epilepsy or brain lesions  you are or your child is on a controlled sodium diet If any of these apply to you, your doctor will decide whether the intended examination is possible or not.
37  tħossok bil- għatx u/ jew jekk kellek biss kwantitajiet żgħar jew xejn x’ tixrob qabel l- eżami  għandek pacemaker kardijaku jew kwalunkwe impjant ferromanjetiku (klipps vaskulari, eċċ.) jew stent tal- metall f’ ġismek  qed tieħu tip speċjali ta ’ mediċina kontra l- pressjoni għolja, i. e. imblokkatur tar- riċetturi beta  għandek mard tal- qalb  tbati minn epilessija jew leżjonijiet fil- moħħ  int jew it- tifel/ tifla tkun fuq dieta kkontrollata tas- sodium Jekk xi waħda minn dawn tapplika għalik, it- tabib tiegħek ser jiddeċiedi jekk l- eżami ppjanat huwiex possibbli jew le.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Pregnancy and breast-feeding Tell your doctor if you are pregnant and ask your doctor or pharmacist for advice before you are given Optimark.
Tqala u treddigħ Għid lit- tabib tiegħek jekk inti tqila u staqsi it- tabib tiegħek jew l- ispiżjar għal parir qabel ma tingħata Optimark.
Driving and using machines If you are an ambulant patient and plan to drive or use tools or machines, take into acount that dizziness may incidentally occur after you undergo a procedure involving the injection of Optimark.
Sewqan u tħaddim ta ’ magni Jekk inti pazjent ambulanti u qed tippjana li ssuq jew tuża għodda jew magni, ikkunsidra l- fatt li l - isturdament jista ’ jseħħ wara li jkollok proċedura li tinvolvi l- injezzjoni ta ’ Optimark.
Important information about some of the ingredients of Optimark This medicine contains less than 1 mmol sodium (23 mg) per dose of up to 17 ml, i. e. essentially ‘ sodium- free’.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Optimark Din il- mediċina fiha inqas minn 1 mmol ta ’ sodium (23 mg) f’ kull doża sa massimu ta ’ 17 ml, jiġifieri, hu essenzjalment ‘ ħieles mis- sodium ’.
Higher doses contain 1 mmol of sodium or more, which have to be taken into consideration if you are or your child is on a controlled sodium diet.
Dożi ogħla fihom 1 mmol ta ’ sodium jew iktar, li jridu jiġu kkunsidrati jekk int jew it- tifel/ tifla tiegħek qegħdin fuq dieta kkontrollata ta ’ sodium.
HOW Optimark IS GIVEN
KIF JINGĦATA Optimark
The usual dose The usual dose is about 14 ml injected over about 7 -14 seconds into a vein, usually a vein in an arm.
Id- doża normali Id- doża normali hi ta ’ madwar 14 ml injettati fuq perjodu ta ’ madwar 7 - 14- il sekonda ġo vina, normalment vina fid- driegħ.
The injection is then flushed through with a saline injection to make sure none is left in the needle or tube used for the injection.
L- injezzjoni tkun imbagħad segwita b’ injezzjoni ta ’ salina biex tiżgura li ma jibqa ’ xejn fil- labra jew it- tubu li jintużaw għall- injezzjoni.
A second dose may be given within 30 minutes of the first injection.
Tista ’ tingħata t- tieni doża fi żmien 30 minuta mill- ewwel injezzjoni.
Certain questions regarding treatment of a brain disease may require the injection of three times the usual dose in one injection.
Ċerti mistoqsijiet dwar il- kura ta ’ mard fil- moħħ jista ’ jkollhom bżonn l- injezzjoni ta ’ tliet darbiet l- ammont ta ’ doża normali li jkun hemm f’ injezzjoni waħda.
The doctor will decide how much Optimark is needed for your examination.
It- tabib ser jiddeċiedi l- ammont ta ’ Optimark li hemm bżonn għall- eżami tiegħek.
You must tell the doctor or nurse/ technologist immediately if you feel pain around the area where the needle is placed.
Int trid tgħid lit- tabib jew lin- ners/ teknoloġista tiegħek immedjatament jekk tħoss l- uġigħ madwar iż- żona fejn titpoġġa l- labra.
If you are given more Optimark than you should have been If too much Optimark was injected it is unlikely that it will do you much harm, as much higher doses did not lead to any problems when some people received them.
Jekk tingħata Optimark aktar milli suppost Jekk ikun injettat wisq Optimark, mhux mistenni li jagħmillek wisq ħsara, għax dożi bil- wisq ogħla ma kkawżaw l- ebda problemi meta xi nies irċivewhom.
If your kidneys are working normally it is unlikely you will have any problems.
Jekk il- kliewi tiegħek qed jaħdmu normali, x’ aktarx li mhux ser ikollok l- ebda problema.
Optimark can be removed using dialysis.
Optimark jista ’ jitneħħa bl- użu tad- dijalisi.
If you think you have been injected with too much Optimark, tell the doctor or nurse/ technologist immediately.
Jekk taħseb li kien injettat wisq Optimark, għid lit- tabib jew lin- ners/ teknoloġista immedjatament.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Jekk ikollok aktar mistoqsijiet dwar l- użu ta ’ din il- mediċina, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicinal products, Optimark can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Optimark jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Most of the undesirable effects observed after the use of Optimark were of mild to moderate intensity and transient in nature.
Il- biċċa l- kbira ta ’ l- effetti mhux mixtieqa osservati wara l- użu ta ’ Optimark kienu ta ’ intensità ħafifa sa moderata u kienu ta ’ natura li jgħaddu malajr.
The most common undesirable effects were a strange taste in the mouth, feeling hot, headache and dizziness.
L- iktar effetti mhux mixtieqa komuni kienu: togħma stramba fil- ħalq, tħoss is- sħana, uġigħ ta ’ ras u sturdament.
Immediately tell the doctor or nurse/ technologist who is giving you the injection, if you feel unwell, especially if you feel any tightness, pain or discomfort in your chest, face or throat, or you have difficulty breathing.
Immedjatament għid lit- tabib jew ners/ teknoloġista li tkun qed tagħtik l- injezzjoni, jekk ma tħossokx tajjeb/ tajba, speċjalment jekk tħoss kwalunkwe tagħfis, uġigħ jew skonfort f’ sidrek, f’ wiċċek jew fil - gerżuma, jew jekk ikollok diffikultà biex tieħu n- nifs.
Possible side effects are described in greater detail below.
L- effetti sekondarji possibbli huma deskritti f’ aktar dettall hawn taħt.
The majority of adverse reactions observed after the use of Optimark were found to be adverse reactions of the nervous system, followed by general adverse reactions, digestive tract disorders/ skin disorders.
Il- maġġoranza tar- reazzjonijiet avversi li kienu osservati wara l- użu ta ’ Optimark instabu li kienu reazzjonijiet avversi tas- sistema nervuża, segwiti minn reazzjonijiet avversi ġenerali, disturbi fil - passaġġ tad- digestjoni/ disturbi tal- ġilda.
The frequencies below and the following symptoms are based on clinical trials, and on the experience in using Optimark after it was on the market:
Il- frekwenzi t’ hawn taħt u s- sintomi li ġejjin huma bbażati fuq provi kliniċi, u fuq l- esperjenza bl- użu ta ’ Optimark wara t- tqegħid fis- suq:
very common: common: uncommon: rare: very rare:
komuni ħafna: komuni: mhux komuni: rari:
In more than 1 of 10 treated patients In less than 1 of 10, but more than 1 of 100 treated patients In less than 1 of 100, but more than 1 of 1,000 treated patients In less than 1 of 1,000, but more than 1 of 10,000 treated patients In 1 case or less of 10,000 treated patients including isolated reports
f’ iktar minn 1 minn kull 10 pazjenti kkurati f’ inqas minn 1 minn kull 10, iżda f’ iktar minn 1 minn kull 100 pazjent ikkurat f’ inqas minn 1 minn kull 100, iżda f’ iktar minn 1 minn kull 1, 000 pazjent ikkurat f’ inqas minn 1 minn kull 1, 000, iżda f’ iktar minn 1 minn kull 10, 000 pazjent ikkurat
Frequency common uncommon
rari ħafna:
Possible side effects dizziness, headache, strange taste in the mouth, feeling hot allergic/ hypersensitivity reaction, tingling sensation, numbness, reduced sense of smell, skin red and warm, nasal congestion, sore throat, nausea, diarrhoea, hives, itching, rash, chest discomfort, feeling cold, administration site reactions
F’ każ 1 jew f’ inqas minn 10, 000 pazjenti kkurati, li jinkludu rapporti iżolati
rare
Frekwenza komuni mhux komuni rari
decreased appetite, feeling anxious, sleep disorder, fainting, shaking, drowsy feeling, burning sensation, ringing in the ears, eyelid redness, eye pain, vision blurred, fast heart beat, awareness of the heartbeat, irregular heartbeats, extra heartbeats, low blood pressure, high blood pressure, shortness of breath, hoarseness, cough, runny nose, throat constriction, mouth watering, vomiting, abdominal pain, constipation, dry mouth, cold sweat, redness, sweating, higher blood level of a substance (creatinine) usually eliminated by the kidneys, blood in urine, chest pain, face swollen, fatigue, fever, swelling in limbs, pain, cold feeling in extremities, liver enzyme increased, urine analysis abnormal, mineral values in urine increased, heart and muscle enzyme increased, decreased haemoglobin, changes in blood calcium levels
Effetti sekondarji li jista ’ jkollu sturdament, uġigħ ta ’ ras, togħma stramba f’ ħalqek, tħoss is- sħana reazzjoni allerġika/ sensittività eċċessiva, sensazzjoni ta ’ tingiż, tnemnim, sens tax - xamm imnaqqas, il- ġilda tkun ħamra u taħraq, konġestjoni nażali, uġigħ fil- griżmejn, dardir, dijarea, urtikarja, ħakk, raxx, skonfort fis- sider, tħoss il- bard, reazzjonijiet fis- sit ta ’ l- għoti nuqqas t’ aptit, tħossok anzjuż, problemi biex torqod, iħossok ħażin, rogħda, tħossok bi ngħas, sensazzjoni ta ’ ħruq, tisfir fil- widnejn, ħmura f’ tebqet il- għajn, uġigħ fl - għajnejn, vista mċajpra, taħbit tal- qalb mgħaġġel, tħossok konxju tat- taħbit tal- qalb, taħbit tal- qalb irregolari, taħbit tal- qalb addizzjonali, pressjoni tad- demm baxxa, pressjoni tad- demm għolja, qtugħ ta ’ nifs, tinħanaq, sogħla, imnieħer inixxi, restrizzjoni fil- gerżuma, żieda tal- bżieq fil- ħalq, rimettar, uġigħ ta ’ żaqq, stitikezza, ħalq xott, għaraq kiesaħ, ħmura, għaraq, livell ogħla fid- demm ta ’ sustanza (kreatinina) li normalment tkun eliminata mill- kliewi, demm fl- awrina, uġigħ fis- sider, wiċċ minfuħ, għeja kbira, deni, nefħa fid- dirgħajn/ riġlejn, uġigħ, sensazzjoni ta ’ kesħa fl - estremitajiet, żieda fl- enzimi fil- fwied, analiżi anormali ta ’ l- awrina, żieda fil- figuri tal - minerali fl- awrina, żieda fl- enzimi fil- qalb u fil- muskoli, tnaqqis fl- emoglobina, bidliet fil- livelli tal- calcium fid- demm
very rare
rari ħafna
Feeling confused, convulsion, bloodshot eyes, heart beat irregularities, tightening of the airways, swollen throat or vocal cords, raw throat, itchy nose, sneezing, swelling around the eyes, flu-like symptoms, feeling unwell, problems with the electrical rhythm of the heart (long QT)
Tħossok konfuż, konvulżjoni, għajnejn ħomor, taħbit tal- qalb irregolari, il- passaġġi tan - nifs jidjiequ, gerżuma jew kordi vokali minfuħin, brix fil- gerżuma, ħakk fl- imnieħer, għatis. nefħa madwar l- għajnejn, sintomi bħal ta ’ l- influwenza, ma tħossokx tajjeb, problemi fir- rittmu elettriku tal- qalb (QT twil)
Cases of abnormalities of the skin including thickening/ inflammation or fibrosis (NSF) have been reported.
Każijiet ta 'anormalitajiet tal- ġilda li jinkludu li l- ġilda teħxien/ tinfjamma jew fibrożi (NSF) kienu rrappurtati.
When Optimark was used in children aged 2 or older they had similar side effects as in adults.
Meta Optimark intuża fit- tfal ta ’ sentejn jew iktar, dawn kellhom effetti sekondarji simili bħala dawk ta ’ l- adulti.
You must report any of the following symptoms immediately to the doctor or nurse/ technologist, and get immediate treatment as they can be or can become very serious: side effects affecting the heart (fainting, extra heart beats, chest pain) or the respiratory system (shortness of breath, tightening of the airways, swollen or tight throat, itchy or runny nose, sneezing).
39 Għandek tirrapporta kwalunkwe wieħed minn dawn is- sintomi li ġejjin immedjatament lit- tabib jew lin- ners/ teknoloġista, u tikseb kura immedjata, għax dawn jistgħu jkunu serji ħafna, jew jistgħu jsiru serji ħafna. effetti sekondarji li jaffettwaw il- qalb (ħass ħażin, taħbit tal- qalb addizzjonali, uġigħ fis - sider) jew is- sistema respiratorja (qtugħ ta 'nifs, il- passaġġi tan- nifs jidjiequ, gerżuma minfuħa jew tħossha dejqa, ħakk fl- imnieħer jew imnieħer inixxi, għatis).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Għandek tirrapporta kwalunkwe wieħed minn dawn is- sintomi immedjatament lit- tabib jew lin - ners/ teknoloġista, u tikseb kura immedjata, għax dawn jistgħu jkunu serji ħafna.
HOW TO STORE Optimark
KIF TAĦŻEN Optimark
Do not use Optimark after the expiry date which is stated on the label.
Tużax Optimark wara d- data ta ’ skadenza li tidher fuq it- tikketta.
Keep the syringe in the outer carton in order to protect from light.
Żomm is- siringi fil- kartuna ta ’ barra biex tilqa ’ mid- dawl.
Medicinal products should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Optimark contains  The active substance is gadoversetamide.
X’ fih Optimark  Is- sustanza attiva hi gadoversetamide.
1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.  The other ingredients are: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/ or hydrochloric acid, water for injections.
1 ml fih 330. 9 mg ta ’ gadoversetamide, ekwivalenti għal 500 mikromol.  Is- sustanzi l- oħra huma: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide u/ jew hydrochloric acid, ilma għall- injezzjonijiet.
What Optimark looks like and contents of the pack Optimark syringes contain a clear, colourless to pale yellow solution.
Id- dehra ta ’ Optimark u d- daqs tal- pakkett Is- siringi Optimark fihom soluzzjoni ċara, bla kulur jew ta ’ kulur isfar ċar.
Optimark is supplied in pre-filled syringes made of polypropylene.
Optimark hu fornut f’ siringi mimlijin għal- lest magħmulin mill- polypropylene.
Optimark pre-filled syringes are supplied in the following package sizes:
Optimark siringi mimlijin għal- lest huma fornuti fid- daqsijiet tal- pakkett li ġejjin:
1 x 10 ml 10 x 10 ml 1 x 15 ml 10 x 15 ml 1 x 20 ml 10 x 20 ml 1 x 30 ml 10 x 30 ml Not all package sizes may be marketed.
1 x 10 ml 10 x 10 ml 1 x 15 ml 10 x 15 ml 1 x 20 ml 10 x 20 ml 1 x 30 ml 10 x 30 ml Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Do not use the solution if it is discoloured or particulate matter is present.
Tużax is- soluzzjoni jekk tkun biddlet il- kulur jew jekk ikun hemm xi frak.
Marketing Authorisation Holder For any information about this medicine, please contact the Marketing Authorisation Holder:
40 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lid- detentur ta ’ l - awtorizzazzjoni għat- tqegħid fis- suq:
Manufacturer Mallinckrodt Medical Imaging Ireland Damastown Mulhuddart, Dublin 15 Ireland
Manifattur Mallinckrodt Medical Imaging Ireland Damastown Mulhuddart, Dublin 15 L- Irlanda
{MM/ YYYY}
Dan il- fuljett kien approvat l- aħħar fi
Detailed information on this product is available on the European Medicines Agency (EMEA) web site http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - mediċini (EMEA) http: // www. emea. europa. eu
38 The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
Therapeutic indications Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver.
Indikazzjonijiet terapewtiċi Optimark hu indikat għall- użu ma ’ l- istrument ta ’ l- immaġni bir- riżonanza manjetika (MRI) tas - sistema nervuża ċentrali (CNS) u l- fwied.
It provides contrast enhancement and facilitates visualization and helps with characterization of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology.
Jipprovdi titjib tal- kuntrast u jiffaċilita l- viżwalizzazzjoni u jgħin fil- karatterizzazzjoni tal- leżjonijiet fokali u strutturi anormali fis- CNS u fil- fwied f’ pazjenti b’ patoloġija magħrufa jew issuspettata b’ mod qawwi.
Special warnings and precautions for use As with any paramagnetic contrast agent, enhancement of MRI with Optimark may impair the visualization of existing lesions.
Twissijiet speċjali u prekawzjonijiet għall- użu Bħal fil- każ ta ’ kull sustanza tal- kuntrast paramanjetika, it- titjib tal- MRI b’ Optimark jista ’ jillimita l - viżwalizzazzjoni ta ’ leżjonijiet eżistenti.
Therefore, caution should be exercised when contrast enhanced scan interpretation is made in the absence of a companion unenhanced MRI.
Għalhekk, għandha tingħata attenzjoni meta ssir interpretazzjoni ta ’ skan mtejba bil- kuntrast fl- assenza ta ’ MRI oħra mhux imtejba.
The usual contraindications of MR examinations must be applied, such as exclusion of patients with infusion pumps, pacemakers, ferro-magnetic clips etc.  Hypersensitivity Allergoid and other idiosyncratic reactions may occur with all contrast media for intravenous application, also with gadoversetamide, which could become manifest in form of cardiovascular, respiratory and skin reactions.
 Sensittività eċċessiva Reazzjonijiet allerġojdi u reazzjonijiet idjosinkratiċi oħrajn jistgħu jseħħu b’ kull mezz tal- kuntrast għall- għoti ġol- vina, anke b’ gadoversetamide, li jistgħu jidhru taħt is- sura ta ’ reazzjonijiet kardjovaskulari, respiratorji u tal- ġilda.
As with all other contrast media of the same class, late reactions may occur (after hours or days) in rare cases; however, none were reported in the completed clinical trials.
Bħal fil- każ tal- mezzi tal- kuntrast l- oħrajn kollha ta ’ l- istess klassi, jistgħu jseħħu reazzjonijiet aktar tard (wara sigħat jew jiem) f’ każijiet rari; madankollu, dawn ma kienux irrappurtati fil- provi kliniċi li tlestew.
iodine-based contrast agents Before the injection of contrast media, patients should be asked whether they have any allergies (e. g. allergies to seafood or medicinal products, hay fever, urticaria), whether they are hypersensitive to contrast media and whether they have bronchial asthma.
Qabel l- injezzjoni ta ’ mezz tal- kuntrast, il- pazjenti għandhom jiġu mistoqsija jekk għandhomx xi allerġiji (eż. allerġiji għall- frott tal- baħar jew prodotti mediċinali, hay fever, urtikarja), jekk 41 għandhomx sensittività eċċessiva għall- mezz tal- kuntrast u jekk għandhomx ażżma tal- bronki.
Premedication with antihistamines and/ or glucocorticoids may be considered.  Patients taking beta-blockers It should be noted that patients using beta-blockers do not necessarily respond to the beta-agonists usually used for the treatment of hypersensitivity reactions.  Patients with cardiovascular disease In this group of patients hypersensitivity reactions may be severe.
Tista ’ tiġi kkunsidrata l- medikazzjoni minn qabel b’ antistamini u/ jew glukokortikojdi.  Pazjenti li qed jieħdu imblokkaturi tar- riċetturi beta Wieħed għandu jkun jaf li pazjenti li jkunu qed jużaw imblokkaturi tar- riċetturi beta mhux neċessarjament li jirrispondu għal agonisti beta li normalment jintużaw għall- kura ta ’ reazzjonijiet ta ’ sensittività eċċessiva.  Pazjenti b’ mard kardjovaskulari F’ dan il- grupp ta ’ pazjenti, ir- reazzjonijiet ta ’ sensittività eċċessiva jistgħu jkunu severi.
Especially in patients with serious heart diseases (e. g. severe heart failure, coronary artery disease) cardiovascular reactions may deteriorate.
B’ mod speċjalment f’ pazjenti b’ mard serju tal- qalb (eż. kollass serju tal- qalb, mard ta ’ l- arterja koronarja), ir - reazzjonijiet kardjovaskulari jistgħu jmorru għall- agħar.
However, these were not evident from clinical trials with Optimark.  Central nervous system disorders In patients suffering from epilepsy or brain lesions the likelihood of convulsions during the examination may be increased.
Madankollu, dawn ma kienux evidenti fi provi kliniċi b’ Optimark.  Disturbi tas- sistema nervuża ċentrali F’ pazjenti li jbatu minn epilessija jew leżjonijiet fil- moħħ, il- possibbiltà ta ’ konvulżjonijiet matul l - eżami tista ’ tiżdied.
Precautions are necessary when examining these patients (e. g. monitoring of the patient) and the equipment and medicinal products needed for the rapid treatment of possible convulsions should be available.  Renal impairment and liver transplant patients There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with severe renal impairment (GFR < 30ml/ min/ 1.73m2), and in those who have had or are undergoing liver transplantation.
Il- prekawzjonijiet huma meħtieġa meta jiġu eżaminati dawn il- pazjenti (eż. monitoraġġ tal- pazjent) u t- tagħmir u l- prodotti mediċinali meħtieġa għall- kura fil- pront ta ’ konvulżjonijiet possibbli għandhom ikunu disponibbli.  Indeboliment tal- kliewi u pazjenti li jkollhom trapjant tal- fwied Kien hemm rapporti ta ’ fibrożi sistemika nefroġenika (NSF) assoċjata ma ’ l- użu ta ’ xi sustanzi tal - kuntrast li fihom gadolinium f’ pazjenti b’ indeboliment sever tal- kliewi (GFR < 30ml/ min/ 1. 73m2) u dawk li kellhom, jew li bħalissa għaddejjin minn trapjant tal- fwied.
Cases of NSF have also been reported in patients
Għalhekk Optimark m’ għandux jintuża f’ dawn il- popolazzjonijiet.
39 with moderate renal impairment (GFR < 60ml/ min/ 1.73m2) with use of gadolinium-containing contrast agents.
Każijiet ta ’ NSF kienu wkoll irrappurtati f’ pazjenti b’ indeboliment moderat tal- kliewi (GFR < 60ml/ min/ 1. 73m2) bl- użu ta ’ sustanzi tal- kuntrast li fihom gadolinium.
Optimark should be used in these patients with caution.
Optimark għandu jintuża bl- attenzjoni f’ dawn il- pazjenti.
Higher doses contain 1 mmol of sodium or more, which should be taken into consideration for patients on a controlled sodium diet.  Serum iron and zinc Caution should be exercised because transient decreases in serum iron and zinc parameters have been observed in clinical trials.
Dożi ogħla fihom 1 mmol ta ’ sodium jew iktar, li għandhom ikunu kkunsidrati għal pazjenti fuq dieta kkontrollata ta ’ sodium.  Ħadid fis- serum u zinc Għandha tingħata attenzjoni minħabba li tnaqqis li jgħaddi malajr fil- parametri tal- ħadid u taż- zinc fis - serum kien osservat fi provi kliniċi.
Pregnancy and Lactation There is no clinical experience with the use of gadoversetamide during pregnancy.
Tqala u Treddigħ M’ hemm l- ebda esperjenza klinika bl- użu ta ’ gadoversetamide waqt it- tqala.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Studji fuq il- bhejjem ma jurux effetti ħżiena diretti jew indiretti fir- rigward tat- tossiċità fis- sistema riproduttiva (ara sezzjoni 5. 3).
The degree of excretion of gadoversetamide in breast milk has not been studied in humans.
Il- livell ta ’ tneħħija ta ’ gadoversetamide fil- ħalib tas- sider ma kienx studjat fil- bniedem.
Posology and method of administration The agent should be administered as a bolus peripheral intravenous injection at a dose of 0.2 ml/ kg (0.1 mmol/ kg) body weight.
Pożoloġija u metodu ta ’ kif għandu jingħata Is- sustanza għandha tingħata bħala injezzjoni ġol- vina periferali bolus f’ doża ta ’ 0. 2 ml/ kg (100 mikromol/ kg) ta ’ piż tal- ġisem.
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%) injection.
42 injezzjoni għandha tkun segwita minn injezzjoni flush ta ’ 5 ml ta ’ sodium chloride 9 mg/ ml (0. 9%).
In cranial MRI, if a strong clinical suspicion of a lesion persists despite a single dose contrast- enhanced 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 0.1 mmol/ kg may be administered within 30 minutes of the first injection as it may increase the diagnostic yield of the examination.
F’ MRI kranjali, jekk jippersisti suspett kliniku qawwi b’ saħħtu ta ’ leżjoni, minkejja doża waħda ta ’ MRI bil- kuntrast 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 ’ 100 mikromol/ kg sa 30 minuta mill- ewwel injezzjoni peress li dan jista ’ jtejjeb ir- riżultat dijanjostiku ta ’ l- eżami.