qanastek/EMEA-V3 huggingface dataset:
1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
1 ml fih 330. 9 mg ta ’ gadoversetamide, ekwivalenti għal 500 mikromol.
6.0 – 7.5 Osmolality (37°C):
Soluzzjoni ċara, bla kulur jew ta ’ kulur isfar ċar. pH 6. 0 – 7. 5 Osmolalità (37°C):
Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver.
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 the 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.
Optimark should only be administered by physicians experienced in clinical MRI practice.
Optimark għandu jingħata biss minn tobba li għandhom esperjenza fil- prattika klinika tal- MRI.
The agent should be administered as a bolus peripheral intravenous injection at a dose of 0.2 ml/ kg (100 micromol/ kg) body weight.
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.
Sabiex tkun żgurata l- injezzjoni sħiħa tal- mezz tal- kuntrast, l - injezzjoni għandha tkun segwita minn injezzjoni flush ta ’ 5 ml ta ’ sodium chloride 9 mg/ ml (0. 9%).
The imaging procedure should be completed within 1 hour of administration of the contrast medium.
Il- proċedura ta ’ l- immaġni għandha titlesta fi żmien siegħa mill- għoti tal- mezz tal- kuntrast.
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 100 micromol/ 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 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.
The safety of repeat doses has not been established in children and adolescents, in patients with renal impairment, or the elderly.
Is- sigurtà ta ’ dożi ripetuti ma kienitx stabbilita fit- tfal u fl- adeloxxenti, f’ pazjenti b’ indeboliment tal- kliewi, jew fl- anzjani.
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.
Informazzjoni limitata dwar sustanzi oħrajn tal- kuntrast ta ’ gadolinium tissuġġerixxi li għall - esklużjoni ta ’ metastasi kranjali addizzjonali f’ pazjent b’ metastasi solitarja magħrufa li tista ’ tinqata ’, eżami ta ’ MR b’ injezzjoni tad- doża ta ’ 300 mikromol/ kg ta ’ piż tal- ġisem ta ’ Optimark, jista ’ jwassal għal kunfidenza dijanjostika ogħla.
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 kienitx 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.
2 Insertion of a flexible in-dwelling venous catheter is recommended, see section 4.4.
2 L- inserzjoni ta ’ kateter venuż in- dwelling flessibbli hu rakkomandat, ara sezzjoni 4. 4.
Hypersensitivity to gadoversetamide or to any of the excipients or to other gadolinium containing products.
Sensittività eċċessiva għal gadoversetamide jew għal xi sustanzi mhux attivi jew għal prodotti oħrajn li fihom gadolinium.
Optimark is contraindicated in patients with severe renal impairment (GFR < 30ml/ min/ 1.73m2), and those who have had or are undergoing liver transplantation (see section 4.4).
Optimark hu kontra- indikat f’ pazjenti b’ indeboliment sever tal- kliewi (GFR < 30ml/ min/ 1. 73m2), u dawk li kellhom jew li jkun qed isirilhom trapjant tal- fwied (are sezzjoni 4. 4).
As with any paramagnetic contrast agent, enhancement of MRI with gadoversetamide may impair the visualization of existing lesions.
Bħal fil- każ ta ’ kull sustanza tal- kuntrast paramanjetika, it- titjib tal- MRI b’ gadoversetamide jista ’ jillimita l- viżwalizzazzjoni ta ’ leżjonijiet eżistenti.
Some of these lesions may be seen on unenhanced, non-contrast MRI.
Uħud minn dawn il- leżjonijiet jistgħu jidhru fuq MRI mhux imtejba u bla kuntrast.
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.
Before the examination, care must be taken that patients are sufficiently hydrated.
Qabel l- eżami, għandha tingħata attenzjoni li l- pazjenti jkunu idratati b’ mod suffiċjenti.
The usual contraindications of MR examinations must be applied, such as exclusion of patients with infusion pumps, pacemakers, ferro-magnetic clips etc.
Il - kontraindikazzjonijiet normali ta ’ l- eżami ta ’ l- MR għandhom ikunu applikati, bħall- esklużjoni ta ’ pazjenti b’ pompi ta ’ l- infużjoni, pacemakers, klipps ferro- manjetiċi, eċċ.
 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 (see section 4.8).
 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 (ara sezzjoni 4. 8).
Most of these reactions occur within half an hour after administering the contrast medium.
Ħafna minn dawn ir- reazzjonijiet iseħħu sa nofs siegħa wara l- għoti tal- mezz tal- kuntrast.
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 xi sigħat jew jiem) f’ każijiet rari; madankollu, dawn ma kienux irrappurtati fil- provi kliniċi li tlestew.
If hypersensitivity reactions occur, the administration of the contrast medium must be discontinued immediately and intravenous treatment initiated, if necessary.
Jekk iseħħu reazzjonijiet ta ’ sensittività eċċessiva, l- għoti tal- mezz tal- kuntrast għandu jitwaqqaf immedjatament u għandha tinbeda kura ġol- vina, jekk meħtieġ.
During the examination, supervision by a physician is necessary and insertion of a flexible in-dwelling catheter is recommended.
Matul l- eżami, hemm bżonn ta ’ superviżjoni minn tabib, u l- inserzjoni ta ’ kateter in- dwelling flessibbli hi rakkomandata.
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.
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.
The risk of hypersensitivity reactions is increased in the following cases:
Ir- riskju ta ’ reazzjonijiet ta ’ sensittività eċċessiva jiżdied fil- każijiet li ġejjin:
- patients with allergic predisposition
- pazjenti bi predispożizzjoni allerġika
- patients with bronchial asthma; in these patients it is especially the risk of bronchospasm which is
- pazjenti b’ ażżma tal- bronki; f’ dawn il- pazjenti, hu r- riskju ta ’ bronkospażmu li jiżdied b’ mod
increased
partikulari;
- patients with a history of reactions to contrast agents, including a previous history of reaction to
- pazjenti b’ passat mediku ta ’ reazzjonijiet għal sustanzi tal- kuntrast, li tinkludi passat mediku
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 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.
Wieħed għandu jkun jaf li pazjenti li jkunu qed jużaw imblokkaturi tar- riċetturi beta mhux neċessarjament 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 speċjali 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.
3  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.
3  Disturbi tas- sistema nervuża ċentrali F’ pazjenti li jbatu minn epilessija jew leżjonijiet fil- moħħ, il- possibbiltà ta ’ konvulżjonijiet matul l - eżami tista ’ tiżdied.
Therefore Optimark should not be used in these populations (see section 4.3).
Għalhekk Optimark m’ għandux jintuża f’ dawn il- popolazzjonijiet (ara sezzjoni 4. 3).
Cases of NSF have also been reported in patients 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.
Gadoversetamide is dialysable.
Gadoversetamide hu dijalizabbli.
Haemodialysis shortly after Optimark administration in patients currently receiving haemodialysis may be useful at removing Optimark from the body.
L- emodijalisi ftit wara l- għoti ta 'Optimark f' pazjenti li bħalissa jkunu qed jirċievu l- emodijalisi jista' jkun utli biex tneħħi Optimark mill- ġisem.
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.
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 u tfal żgħar Optimark m’ għandux jintuża fi tfal li għandhom inqas minn sentejn.
Safety and efficacy have not been studied in this age group.  Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose of up to 17 ml, i. e. essentially ‘ sodium- free’.
Is- sigurtà u l- effikaċja ma kienux studjati fil- grupp ta ’ din l- età.  Sodium Dan il- prodott mediċinali fih 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 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 ta ’ l- iron u taż- zinc fis - serum kien osservat fi provi kliniċi.
No formal interaction studies have been performed.
Ma sarux l- ebda studji formali dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott.
Optimark has been shown to cause interference in the measurement of serum calcium using the ortho- cresolphthalein complexone (OCP) colorimetric method.
Intwera li Optimark jikkawża interferenza fil- kejl tal- calcium fis- serum bl- użu tal- metodu kolorimetriku ortho- cresolphthalein complexone (OCP).
However, the administration of gadoversetamide does not cause a true decrease in serum calcium.
Madankollu, l- għoti ta ’ gadoversetamide ma jikkawżax tnaqqis veru tal- calcium fis- serum.
In the presence of gadoversetamide, the OCP technique produces an erroneous, low value for plasma calcium.
Fil- preżenza ta ’ gadoversetamide, it- teknika OCP tipproduċi figura baxxa żbaljata għall- calcium fil- plażma.
The magnitude of this measurement artefact is proportional to the concentration of gadoversetamide in the blood, and in patients with normal renal clearance accurate values can be obtained approximately 90 minutes following injection.
Il- kobor ta ’ dan il- artefatt tal- kejl hu proporzjonali għall- konċentrazzjoni ta ’ gadoversetamide fid- demm, u f’ pazjenti bi tneħħija normali mill- kliewi, figuri preċiżi jistgħu jinkisbu madwar 90 minuta wara l- injezzjoni.
In patients with compromised renal function, clearance of gadoversetamide will be slowed and the interference with calcium determination by OCP prolonged.
F’ pazjenti b’ funzjoni tal- kliewi kompromessa, it- tneħħija ta ’ gadoversetamide ser issir aktar bil- mod u l- interferenza fil- kejl tal- calcium bl- OCP ser titwal.
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.
Gadoversetamide ma jaffettwax metodi oħra ta ’ kejl tal- calcium fis - serum, bħall- metodu kolorimetriku arsenazo III, l- ispettroskopija b’ assorbiment atomiku, u l - inductively coupled plasma mass spectroscopy.
4.6 Pregnancy and Lactation
4. 6 Tqala u Treddigħ
There is no clinical experience with the use of gadoversetamide during pregnancy.
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 (see section 5.3).
Studji fuq il- bhejjem ma jurux effetti ħżiena diretti jew indiretti fir- rigward tat- tossiċità fis- sistema riproduttiva (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Ir- riskju potenzjali ghall- bnedmin mhuwiex magħruf.
Optimark should not be used during pregnancy except in cases where a contrast enhanced MR scan is determined to be critical, with no acceptable alternative imaging examination.
Optimark m’ għandux jintuża waqt it- tqala ħlief f’ każijiet fejn l- iskan MR bil- kuntrast imtejjeb ikun stabbilit li hu kritiku, bl- ebda alternattiva aċċettabbli ta ’ l- eżami ta ’ l- immaġni.
The degree of excretion of gadoversetamide in breast milk has not been studied in humans.
4 Il- livell ta ’ tneħħija ta ’ gadoversetamide fil- ħalib tas- sider ma kienx studjat fil- bniedem.
Based on animal studies, the rate of excretion is expected to be low.
Ibbażat fuq studji fl- annimali, ir- rata ta ’ tneħħija hi mistennija li tkun baxxa.
At clinical doses no effects on the suckling child are anticipated.
F’ dożi kliniċi, l- ebda effetti fuq it - tarbija li tkun terda ’ m’ huma mistennija.
Optimark can be used during breast-feeding.
Optimark jista ’ jintuża waqt it- treddigħ.
Ambulant patients while driving vehicles or operating machinery should take into account that dizziness may incidentally occur.
Pazjenti ambulanti waqt li jkunu qed isuqu l- vetturi jew iħaddmu l- makkinarju, għandhom jikkunsidraw li l- isturdament jista ’ jseħħ inċidentalment.
4.8 Undesirable Effects
4. 8 Effetti mhux mixtieqa
Most of the undesirable effects were of mild to moderate intensity and transient in nature.
Il- biċċa l- kbira ta ’ l- effetti mhux mixtieqa kienu ta ’ intensità ħafifa għal moderata u kienu ta ’ natura li jgħaddu malajr.
The most common undesirable effects were dysgeusia, feeling hot, headache and dizziness.
L- aktar effetti komuni mhux mixtieqa kienu indeboliment fis- sens tat- togħma, tħoss is- sħana, uġigħ ta ’ ras u sturdament.
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.
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.
The following drug-related adverse reactions have been reported from clinical trials and from post- marketing use of gadoversetamide.
Ir- reazzjonijiet avversi li ġejjin marbuta mal- mediċina kienu rrappurtati minn provi kliniċi u mill- użu ta ’ wara t- tqegħid fis- suq ta ’ gadoversetamide.
System Organ
Klassi tas- sistema
Rare
Rari (≥1/ 10, 000,
Class
ta ’ l- Organi
(≥ 1/ 1,000,
(≥1/ 1, 000,
(≥ 1/ 10,000, < 1/ 1,000)
< 1/ 1, 000)
(MedDRA) Immune System Disorders Metabolism and
(MedDra) Disturbi fis- sistema immuni Disturbi fil -
< 1/ 100) Anaphylactic reaction
< 1/ 100) Reazzjoni anafilattika
Nutrition Disorders Psychiatric
metaboliżmu u n - nutrizzjoni
Decreased appetite
Nuqqas t’ aptit Ansjetà, Problemi biex
Disorders
Disturbi psikjatriċi
Anxiety, Sleep disorder
Sturdament, Uġigħ ta ’
Dizziness,
torqod
Syncope, Tremor,
Stat ta ’ konfużjoni
Disorders
Disturbi fis- sistema
Headache,
ras,
Paraesthesia,
Ipoestesija,
Somnolence, Burning
Sinkope, Rogħda,
Parosmia
nervuza
sensation Erythema of eyelid,
Indebolime nt fis- sens tat- togħma
Eye Disorders Ear and
Parestesija, Parosmja
Eye pain, Vision blurred
Ngħas, Sensazzjoni ta ’ ħruq Eritema ta ’ tebqet il -
Arrhythmia
Konvulzjoni
Disorders
Disturbi fl- għajnejn
first degree, Extrasystoles
għajn, Uġigħ fl -
Hypotension,
Iperimija ta ’ l -
Nasal congestion, Throat irritation
Disturbi fil- widnejn u fis- sistema labirintika
Bronchospasm, Pharyngeal oedema, Pharyngitis, Rhinitis, Sneezing
għajnejn, Vista mċajpra Żarżir fil- widnejn Takikardja, Palpitazzjonijiet,
Diarrhoea
għajnejn
pain, Constipation, Dry mouth
Disturbi fil- qalb
Cold sweat, Erythema, Hyperhidrosis
Imbokk AV ta ’ l - ewwel grad, Extrasystoles
Periorbital oedema
Arritmja
5
5 Klassi tas- sistema
(MedDRA) Renal and Urinary Disorders
(MedDra)
Blood creatinine increased, Hematuria
Disturbi vaskulari
General
Fwawar
discomfort,
Disturbi
Pain, Chest pain, Face
Irritazzjoni fil -
Disorders and
Farinġite, Rinite,
Feeling hot
gerżuma
Feeling cold,
Dwejjaq fil- gerżuma Żieda fil- produzzjoni
oedema, Fatigue, Fever,
Disturbi gastro - intestinali Disturbi fil- ġilda u
Malaise, Feeling
fit- tessuti ta ’ taħt il - ġilda Disturbi fil- kliewi u
Administration
Urtikarja, Ħakk, Raxx
Administration
Edema periorbitali
Oedema peripheral,
fis- sistema urinarja
abnormal,
Disturbi ġenerali u
Site Conditions
sider, Tħoss il -
site reactions
Tħoss is -
Peripheral coldness ALT increased, Urine analysis abnormal, Urine electrolytes
bard,
Investigations
kbira, Deni, Edema
abnormal CPK
Telqa, Ma tħossokx
Electrocardiogram
Reazzjonijiet fis- sit ta ’ l- għoti
Increased, Haemoglobin decreased, Blood calcium abnormal
periferali, Tħoss il - ksieħ fil- partijiet periferali Żieda fl- ALT, Analiżi anormali ta ’ l- awrina, Elettroliti anormali fl - awrina, Żieda fis- CPK, Tnaqqis fl- emoglobina, Livell ta ’ calcium anormali fid- demm
QT prolonged
normali, Titwil tal- QT fl - elettrokardjogramm
Serious adverse reactions have been reported and include anaphylactic reactions, cardiovascular reactions, and allergic respiratory disorders.
Reazzjonijiet avversi serji kienu rrappurtati u jinkludu reazzjonijiet anafilattiċi, reazzjonijiet kardjovaskulari u disturbi respiratorji allerġiċi.
Treatment should be symptomatic and immediate access to necessary medicinal products and emergency equipment should be available should a serious event occur.
Il- kura għandha tkun sintomatika u aċċess immedjat għall- prodotti mediċinali meħtieġa u tagħmir ta ’ emerġenza għandu jkun disponibbli fil- każ li jseħħ avveniment serju.
Local reactions have occurred at the injection site and may lead to local irritation type reactions.
Reazzjonijiet lokali seħħew fis- sit ta ’ l- injezzjoni u jistgħu jwasslu għal reazzjonijiet tat- tip ta ’ irritazzjoni lokali.
Cases of Nephrogenic Systemic Fibrosis have been reported.
Każijiet ta ’ Fibrożi Sistemika Nefroġenika (NSF) kienu rrappurtati.
Gadoversetamide has been tested in humans in doses up to 700 micromol/ kg (seven times the standard dose).
Gadoversetamide kien ittestjat fil- bnedmin f’ dożi sa massimu ta ’ 700 mikromol/ kg (seba ’ darbiet iktar mid- doża standard).
Clinical consequences of an overdose have not been reported.
Konsegwenzi kliniċi ta ’ doża eċċessiva ma kienux irrappurtati.
Acute toxicity symptoms are unlikely to occur in patients with normal renal function.
Sintomi ta ’ tossiċità akuti mhumiex mistennija li jseħħu f’ pazjenti b’ funzjoni normali tal- kliewi.
Dialysis can be used to remove gadoversetamide from the blood.
Tista ’ ssir dijalisi biex gadoversetamide jitneħħa mid- demm.
Paramagnetic MRI contrast media, ATC code:
Mezz 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.
6 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.
The purpose of an MRI contrast agent is to induce signal intensity changes within the lesion thereby facilitating its recognition from the surrounding normal structures.
L- iskop tas- sustanza tal- kuntrast tal- MRI hu li tipproduċi bidliet fl- intensità tas- sinjal fil- leżjoni u b’ hekk jiġi ffaċilitat l- għarfien tagħha mill- istrutturi normali tal- madwar.
The use of a contrast agent may therefore reduce the threshold for lesion detection and visualization.
L- użu ta ’ sustanza tal - kuntrast jista ’ għalhekk inaqqas il- limitu li fih ikunu jistgħu jiġu osservati u viżwalizzati l- leżjonijiet.
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.
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.
Gadoversetamide, an extracellular gadolinium chelate, after intravenous administration, equilibrates rapidly within the extracellular fluid/ space and is eliminated primarily by glomerular filtration.
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.
For liver metastases, the signal difference between the tumour and
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.
6 surrounding liver tissue is significantly improved during the first 90 seconds after an extracellular gadolinium contrast agent is administered.
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.
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.
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.
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 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.
This difference in enhancement pattern is useful in formulating a differential diagnosis based on lesion characterization and diagnostic confidence.
Din id- differenza fl- iskema ta ’ titjib hi utli biex tkun ifformulata dijanjosi differenzjata bbażata fuq il- karatterizzazzjoni tal- leżjoni u l- kunfidenza dijanjostika.
The enhancement of brain tumours using a gadolinium (or iodine) containing contrast agent depends on the disruption of the blood brain barrier (BBB).
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).
As a result, these agents have been referred to as markers for sites of abnormal BBB breakdown.
Bħala riżultat, dawn is- sustanzi kienu rriferuti bħala markaturi għal siti bi tkissir anormali tal- BBB.
When the BBB is disrupted, the gadoversetamide molecules diffuse into the interstitial compartment thereby producing the characteristic paramagnetic effect of T1 and T2 shortening.
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.
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.
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.
Distribution The pharmacokinetics of gadoversetamide conforms to a two compartment open-model.
Distribuzzjoni Il- farmakokinetiċi ta ’ gadoversetamide huma konformi ma ’ mudell miftuħ b’ żewġ kompartimenti.
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.
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.
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.
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.
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.
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.
Dose level has no consistent effect on the volume of distribution in any of the studies.
Il- livell tad- doża ma kellu l- ebda effett konsistenti fuq il- volum tad- distribuzzjoni fl- ebda wieħed mill- istudji.
Gadoversetamide does not undergo protein binding in vitro.
Gadoversetamide ma jgħaddix minn fażi ta ’ twaħħil mal- proteini in vitro.
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).
7 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 mil- 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.
Similar results are obtained in normal subjects and patients with various combinations of liver, CNS and renal dysfunctions with renal clearance of gadoversetamide being approximately 95% of the total plasma clearance.
Riżultati simili jinkisbu f’ persuni normali u f’ pazjenti b’ kumbinazzjonijiet varji ta ’ disfunzjonijiet tal- fwied, tas- CNS u tal- kliewi, bi tneħħija mill- kliewi ta ’ gadoversetamide li tkun ta ’ madwar 95% tat- tneħħija totali mill- plażma.
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.
There was no systematic difference in any of the kinetic parameters as a function of dose level (100 to 700 micromol/ kg).
Ma kien hemm ebda differenza sistematika fl- ebda wieħed mill- parametri kinetiċi bħala funzjoni tal - livell tad- doża (100 sa 700 mikromol/ kg).
Therefore, within this dose range, the kinetics of gadoversetamide appear to be linear.
Għalhekk, f’ din il- firxa ta ’ dożi, il- kinetiċi ta ’ gadoversetamide jidhru li huma lineari.
Metabolism The high accountability for the dose as intact complex in urine suggests that no significant metabolism of gadoversetamide occurs in humans.
Metaboliżmu Il- kontabilità għolja għad- doża bħala kumpless intatt fl- awrina tissuġġerixxi li ma jseħħ l- ebda metaboliżmu sinifikanti ta ’ gadoversetamide fil- bnedmin.
7 Special Populations
Popolazzjonijiet Speċjali
Effect of Gender:
L- Effett tas- Sess:
Adult male and female subjects were enrolled in two pharmacokinetic studies.
Irġiel u nisa adulti kienu rreġistrati f’ żewġ studji farmakokinetiċi.
No significant differences in pharmacokinetics based on gender were identified.
Ma kienu identifikati l- ebda differenzi sinifikanti fil- farmakokinetiċi bbażati fuq is- sess.
Effects of Age:
L- Effetti ta ’ l- Età:
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 kkoreġuta 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).
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).
Il- half- life tat- tneħħija fil- gruppi ta ’ età ta ’ 2 sa 11- il sena u 12 sa 18- il sena (1. 4 ± 0. 3 u 1. 6 ± 0. 3 siegħa- 1, rispettivament) hi iqsar minn dik osservata fiż- żewġ popolazzjonijiet adulti (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).
The number of elderly patients in whom the pharmacokinetics were determined was limited (over 65 years, N=3).
In - numru ta ’ pazjenti anzjani li fihom il- farmakokinetiċi kienu ddeterminati kien limitat (iktar minn 65 sena, N=3).
Effect of Renal Impairment 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.
L- Effett ta ’ l- Indeboliment tal- Kliewi Il- livelli ta ’ gadoversetamide fil- plażma jiżiedu b’ mod lineari mat- tnaqqis tal- funzjoni tal- kliewi; 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.
Since gadoversetamide is only administered as a single dose this will lead to a longer and higher exposure for a limited duration.
Billi gadoversetamide jingħata biss bħala doża waħda, dan ser iwassal għal espożizzjoni itwal u ogħla għal tul ta ’ ħin limitat.
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.
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.
Nevertheless, because of reported cases of NSF that may be associated with renal impairment for other gadolinium containing contrast agents and for gadoversetamide, Optimark should not be used in these patients.
Madankollu, minħabba l- każijiet irrappurtati ta ’ NSF li jistgħu jkunu assoċjati ma ’ indeboliment tal- kliewi għal sustanzi tal- kuntrast oħra li fihom gadolinium u għal gadoversetamide, Optimark m’ għandux jintuża f’ dawn il- pazjenti.
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute toxicity, reproductive toxicity, local tolerance, antigenicity, and genotoxicity.
Informazzjoni li mhix klinika, magħmula fuq studji konvenzjonali dwar is- sigurtà farmakoloġika, it - tossiċità akuta, it- tossiċità fis- sistema riproduttiva, it- tolleranza lokali, l- antiġeneċità u l- ġenotossiċità, ma turi l- ebda periklu speċjali għall- bnedmin.
No carcinogenicity studies were performed.
Ma saru l- ebda studji dwar il- karċinoġeniċità.
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.
8 Studji dwar it- tossiċità meta ngħataw dożi ripetuti fil- firien u fil- klieb, żvelaw il- vakwolazzjoni taċ - ċelluli tubulari tal- kliewi, b’ evidenza qawwija għar- riversibbiltà ta ’ l- effett.
No functional impairment was observed.
L- ebda indeboliment fil - funzjoni ma kien osservat.
Versetamide Calcium hydroxide Calcium chloride dihydrate Sodium hydroxide and/ or hydrochloric acid for pH adjustment.
Versetamide Calcium hydroxide Calcium chloride dihydrate Sodium hydroxide u/ jew hydrochloric acid għal aġġustament tal- pH.
Water for injections.
Ilma għall- injezzjonijiet.
In the absence of compatibility studies, Optimark should not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, Optimark m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
6.3 Shelf-life
Żmien kemm idum tajjeb il- prodott mediċinali 6. 3
Chemical and physical in-use stability has been demonstrated for 24 hours at up to 25°C.
L- istabbiltà kimika u dik fiżika waqt l- użu intweriet għal 24 siegħa f’ temperaturi ta ’, u sa, 25°C.
8 From a microbiological point of view, the product should be used immediately.
Mill- aspett mikrobijoloġiku, il- prodott għandu jintuża immedjatament.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Jekk ma jintużax immedjatament, iż- żmien tal- ħażna waqt l- użu u l- kundizzjonijiet ta ’ qabel l- użu huma r - responsabbiltà ta ’ min qed jużah.
Optimark is filled in pre-filled syringes made of polypropylene.
Optimark hu mimli f’ siringi mimlija għal- lest magħmulin mill- polypropylene.
Syringe tip cap and piston are made of bromobutyl rubber.
L- għatu tat- tarf tas - siringa u l- pistun huma magħmulin mil- lastku tal- bromobutyl.
1 x 10 ml 1 x 15 ml 1 x 20 ml 1 x 30 ml
Daqsijiet tal- pakketti:
Optimark is also available in glass vials of 10 ml, 15 ml and 20 ml.
Optimark hu wkoll disponibbli f’ kunjetti tal- ħġieġ ta ’ 10 ml, 15 ml u 20 ml.
6.6 Special precautions for disposal and other handling
9 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Optimark is intended for single use only; any unused portions should be discarded.
Optimark hu intenzjonat biex jintuża darba biss; kwalunkwe porzjonijiet li ma jintużawx għandhom jintremew.
Do not use the solution if it is discoloured or particulate matter is present.
Tużax is- soluzzjoni jekk tkun tilfet il- kulur jew jekk ikun hemm xi frak.
If non-disposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.
Jekk jintuża tagħmir li ma jintremiex wara li tużah, għandha tingħata attenzjoni kbira biex tiġi evitata kontaminazzjoni residwa bit- traċċi tas- sustanzi li jnaddfu.
Assembly and Inspection Inspect the syringe for signs of leakage.
Siringi mimlijin għal- lest Immuntar u Spezzjoni Eżamina s- siringa għal sinjali ta ’ tnixxija.
Do not use if leakage is observed.
Tużax jekk ikun hemm xi tnixxija.
After screwing the push rod into the syringe piston, it is important to turn the push rod an additional ½ turn so that the grey piston rotates freely
Wara li tissikka l- push rod ġol- pistun tas- siringa, hu importanti li ddawwar il- push rod ½ dawra addizzjonali biex il- pistun il- griż idur b’ mod ħieles.
Prior to using the syringe, twist off grey tip cap and discard.
Qabel ma tuża s- siringa, ilwi u aqla ’ l- għatu tat- tarf il- griż u armih.
Syringe is now ready for needle or infusion tubing attachment.
Is- siringa issa hi lesta biex titwaħħal mal- parti annessa tal- labra jew tat- tubu ta ’ l - infużjoni.
Discard syringe and unused portion of the solution after use.
Armi s- siringa u l- porzjon mhux użat tas- soluzzjoni wara l- użu.
Covidien Deutschland GmbH Gewerbepark 1 93333 Neustadt/ Donau Germany
Covidien Deutschland Gewerbepark 1 93333 Neustadt/ Donau Il- Ġermanja
DATE OF REVISION OF THE TEXT
10 DATA TA ’ META ĠIET RIVEDUTA L- KITBA 10.
Optimark 500 micromol/ ml solution for injection in a vial
Optimark 500 mikromol/ ml soluzzjoni għall- injezzjoni f’ kunjett
Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver.
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 the 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.
The agent should be administered as a bolus peripheral intravenous injection at a dose of 0.2 ml/ kg (100 micromol/ kg) body weight.
Is- sustanza għandha tingħata bħala injezzjoni ġol- vina periferali bolus f’ doża ta ’ 0. 2 ml/ kg (100 mikromol/ kg) tal- piż tal- ġisem.
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 100 micromol/ 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 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 ’ 0. 1 mmol/ kg sa 30 minuta mill- ewwel injezzjoni peress li dan jista ’ jtejjeb ir- riżultat dijanjostiku ta ’ l- eżami.
The container and the solution should be inspected prior to use as described in section 6.6.
12 Il- kontenitur u s- soluzzjoni għandhom ikunu eżaminati qabel l- użu kif deskritt f’ sezzjoni 6. 6.
11 Insertion of a flexible in-dwelling venous catheter is recommended, see section 4.4.
L- inserzjoni ta ’ kateter venuż in- dwelling flessibbli hu rakkomandat, ara sezzjoni 4. 4.
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 l - iskaninterpretazzjoni ta ’ skan, mtejba bil- kuntrast fl- assenza ta ’ MRI oħra mhux imtejba.
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.
Sabiex 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.
- patients with a history of reactions to contrast agents, including a previous history of reaction to
- pazjenti b’ passat mediku ta ’ reazzjonijiet għal sustanzi tal- kuntrast, li tinkludi b’ passat mediku
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 imblokkatur tar- riċetturi betaimblokkaturi tar- riċetturi beta Għandu jkun innutat li pazjenti li qed jużaw imblokkatur tar- riċetturi betaimblokkaturi tar- riċetturi beta mhux neċessarjament 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.
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
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.
13 F’ pazjenti li jbatu minn epilessija jew leżjonijiet fil- moħħ, il- possibbiltà ta ’ konvulżjonijiet matul l - eżami tista ’ tiżdied.