qanastek/EMEA-V3 huggingface dataset:
Experience with other contrast media shows that the risk of hypersensitivity reactions is higher in those patients.
L- esperjenza b’ sustanzi oħrajn tal- kuntrast uriet li r- riskju ta ’ reazzjonijiet minħabba sensittività eċċessiva hu ogħla f’ dawk il- pazjenti.
Delayed reactions may occur (after hours to days).
Reazzjonijiet li jseħħu wara ċertu żmien huma possibbli (wara numru ta ’ sigħat jew ġranet).
Caution should also be exercised in the following cases:
Għandha tingħata attenzjoni wkoll f’ dawn il- każijiet li ġejjin:
Hypersensitivity reactions If hypersensitivity reactions occur (See Section 4.8), administration of the contrast medium must be discontinued immediately and - if necessary - specific therapy instituted via a venous access.
Jekk iseħħu reazzjonijiet ta ’ sensittività eċċessiva (Ara Sezzjoni 4. 8), l- għoti tas- sustanza tal- kuntrast għandu jitwaqqaf minnufih u - jekk ikun meħtieġ - tinbeda terapija speċifika minn aċċess venuż.
It is therefore advisable to use a flexible indwelling cannula for intravenous contrast medium administration.
Għalhekk hu rakkomandat li tintuża kannula indwelling flessibbli permanenti għall- għoti tas- sustanza tal- kuntrast ġol- vini.
Due to the possibility of severe hypersensitivity reactions after intravenous contrast administration, preparedness for institution of emergency measures is necessary, e. g., appropriate medicinal products, an endotracheal tube, and a respirator should be at hand.
Minħabba l- possibbiltà ta ’ reazzjonijiet severi minħabba sensittività eċċessiva wara l- għoti tal- sustanza tal- kuntrast ġol- vini, l- istat ta ’ preparazzjoni biex jinbdew miżuri ta ’ emerġenza hu meħtieġ, eż., prodotti mediċinali adattati, tubu endotrakeali, u respiratur għandhom ikunu disponibbli.
Impaired renal function Since gadofosveset is cleared from the body primarily by urinary excretion, caution should be exercised in patients with impaired renal function (See Section 5.2).
Indeboliment tal- funzjoni tal- kliewi Minħabba li gadofosveset jitneħħa mill- ġisem primarjament permezz ta ’ l- eskrezzjoni mill- awrina, għandha tingħata attenzjoni lil dawk il- pazjenti li jkollhom indeboliment fil- funzjoni tal- kliewi (Ara Sezzjoni 5. 2).
Dose adjustment in renal impairment is not necessary.
Aġġustament fid- doża minħabba indeboliment tal- kliewi mhuwiex meħtieġ.
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with
Kien hemm rapporti ta ’ fibrożi sistemika nefroġenika (NSF) assoċjata ma ’ l- użu ta ’ xi sustanzi tal - kuntrast li fihom gadolinium f’ pazjenti b ’
- acute or chronic severe renal impairment (GFR < 30ml/ min / 1.73 m2) or
- indeboliment severi tal- kliewi akut jew kroniku (GFR < 30ml/ min / 1. 73 m2) jew
- acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative
- insuffiċjenza tal- kliewi akuta ta ’ kull severità minħabba sindrome epato- renali jew fil- perjodu
liver transplantation period.
postoperattiv tat- trapjant tal- fwied.
As there is a possibility that NSF may occur with Vasovist, it should therefore only be used in these patients after careful risk/ benefit assessment, and if the diagnostic information cannot be obtained by other means.
Billi hemm possibbiltà li l- NSF tista ’ sseħħ b’ Vasovist, għalhekk dan għandu jintuża biss f’ dawn il - pazjenti wara li ssir analiżi bir- reqqa tar- riskju/ benefiċċju u jekk informazzjoni dianjostika ma tistax tinkiseb bl- ebda mezz ieħor.
All patients should be screened, in particular patients over the age of 65, for renal dysfunction by obtaining a history and/ or laboratory tests.
Il- pazjenti kollha għandhom jiġu ttestjati, speċjalment pazjenti ta ’ età ‘ l fuq minn 65, għal meta l - kliewi ma jaħdmux normali billi jinkiseb il- passat tal- pazjent u/ jew testijiet tal- laboratorju.
Haemodialysis shortly after Vasovist administration in patients currently receiving haemodialysis may be useful at removing Vasovist from the body.
3 Emodijaliżi ftit wara għoti ta ’ Vasovist f’ pazjenti li bħalissa qed jirċievu emodijaliżi tista ’ tkun utli biex tneħħi Vasovist mill- ġisem.
In a clinical trial it was shown that gadofosveset can effectively be removed from the body by dialysis using high flux filters.
Fi prova klinika ntwera li gadofosveset jista ’ jitneħħa effettivament mill- ġisem b’ dijaliżi bl- użu ta ’ filtri high flux.
There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.
M’ hemmx evidenza li ssostni l- bidu ta ’ emodijaliżi għall- prevenzjoni jew kura ta ’ NSF f’ pazjenti li mhux lesti jagħmlu emodijaliżi.
3 Electrocardiographic Changes Elevated levels of gadofosveset (e. g. repeated use in the short term [within 6-8 hours], or an inadvertent overdose > 0.05 mmol/ kg) may be associated with mild QT prolongation (8.5 msec by Fridericia correction).
Bidliet Elettrokardjografiċi Livelli għolja ta ’ gadofosveset (eż. użu ripetut fi żmien qasir [f’ ħin ta ’ 6- 8 sigħat], jew doża eċċessiva li tingħata b’ mod aċċidentali ta ’ > 0. 05 mmol/ kg) tista ’ tkun marbuta ma ’ titwil ħafif tal- QT (8. 5 msec bil- korrezzjoni ta ’ Fridericia).
In the situation of elevated levels of gadofosveset or underlying QT prolongation the patient should be carefully observed including cardiac monitoring.
F’ sitwazzjoni ta ’ livelli għolja ta ’ gadofosveset jew titwil tal- QT bażiku, il- pazjent għandu jiġi osservat bl- attenzjoni, inkluż il- monitoraġġ kardijaku.
Vascular stents It has been shown in published studies that MRA in the presence of metallic stents causes artifacts.
Stents vaskulari Fi studji li kienu ppubblikati, intwera li l- MRA, fil- preżenza ta ’ stents tal- metall, tikkawża artifacts.
The reliability of lumen visualization in a stented vessel with VASOVIST has not been evaluated.
L - affidabilità ta ’ viżwalizzazzjoni lumen f’ vina/ arterja stented b’ VASOVIST ma kinitx evalwata.
4.5 Interaction with other medicinal products and other forms of interaction
Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu 4. 5 l- effett farmaċewtiku tal- prodott
Because gadofosveset is bound to albumin, an interaction with other plasma protein bound active substances (e. g., ibuprofen and warfarin) is generally possible, i. e., a competition for the protein binding site can occur.
Minħabba li gadofosveset jeħel ma ’ l- albumina, interazzjoni ma ’ sustanzi attivi oħrajn imwaħħlin mal - proteina tal- plażma (eż. ibuprofen u warfarin) hi ġeneralment possibbli, i. e., tista ’ sseħħ kompetizzjoni għas- sit fejn dawn jeħlu mal- proteina.
However, in a series of in vitro drug interaction studies (in 4.5% human serum albumin and human plasma), gadofosveset demonstrated no adverse interaction with digitoxin, propranolol, verapamil, warfarin, phenprocoumon, ibuprofen, diazepam, ketoprofen, naproxen, diclofenac and piroxicam at clinically relevant concentrations.
Madankollu, serje ta ’ studji dwar l- interazzjoni tal- mediċinia li saru in vitro (f’ 4. 5% ta ’ l- albumina tas- serum umana u plażma umana), gadofosveset ma wera l- ebda interazzjoni avversa ma ’ digitoxin, propranolol, verapamil, warfarin, phenprocoumon, ibuprofen, diazepam, ketoprofen, naproxen, diclofenac u piroxicam f’ konċentrazzjonijiet klinikament rilevanti.
In vitro studies using human liver microsomes did not indicate any potential to inhibit the cytochrome P 450 enzyme system.
Studji in vitro li użaw mikrosomi tal- fwied uman ma indikaw l- ebda potenzjal li jinibixxi s- sistema ta ’ l- enzima taċ- ċitokromju P 450.
In a clinical study, it was shown that VASOVIST does not affect the unbound fraction of warfarin in plasma.
Fi studju kliniku, intwera li VASOVIST ma jaffettwax il- porzjon mhux imwaħħal ta ’ warfarin fil - plażma.
The anticoagulant activity of warfarin was not altered and the efficacy of the medicinal product was not influenced.
L- attività kontra l- koagulazzjoni ta ’ warfarin ma nbidlitx u l- effikaċja tal- prodott mediċinali ma ġietx influwenzata.
Laboratory Test Interactions In clinical trials using VASOVIST, no specific trends were observed that would signify a potential interaction of the medicinal product with laboratory test methods.
Interazzjonijiet tat- Testijiet tal- Laboratorju Fi studji kliniċi bl- użu ta ’ VASOVIST, ma kienu osservati l- ebda andamenti speċifiċi li kieku kienu jfissru interazzjoni potenzjali tal- prodott mediċinali mal- metodi tat- testijiet tal- laboratorju.
There is no experience with the use of gadofosveset trisodium in pregnant women.
M’ hemmx esperjenza bl- użu ta ’ gadofosveset trisodium f’ nisa tqal.
Animal studies have not provided any evidence for effects on fertility, or perinatal and postnatal development.
Studji fuq l- annimali ma pprovdew l- ebda evidenza dwar l- effetti fuq il- fertilità, jew l- iżvilupp ta ’ qabel jew wara t- twelid.
Embryo-foetal toxicity was observed in the rabbit after repeated administrations (See Section 5.3).
It- tossiċità ta ’ l- embriju u tal- fetu kienet osservata fil- fniek wara dożi għoljin ripetuti (Ara Sezzjoni 5. 3).
VASOVIST should not be used in pregnant women unless strictly necessary, because of lack of experience.
VASOVIST m’ għandux jintuża f’ nisa tqal ħlief jekk ikun strettament meħtieġ, minħabba nuqqas ta ’ tagħrif dwaru.
It is unknown whether gadofosveset trisodium is excreted in human breast milk.
Mhuwiex magħruf jekk gadofosveset trisodium jiġix eskretat fil- ħalib tas- sider uman.
In an animal study, it was shown that less than 1% of the dose of gadofosveset administered enters breast milk.
Fi studju fuq l - annimali, intwera li inqas minn 1% tad- doża mogħtija ta ’ gadofosveset tidħol fil- ħalib tas- sider.
This medicinal product should not be used during breastfeeding, because of lack of experience.
Dan il- prodott mediċinali m’ għandux jintuża waqt it- treddigħ minħabba nuqqas ta ’ tagħrif dwaru.
No studies on the effects on the ability to drive and use machine have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
The most common adverse drug-related reactions were pruritus, paresthesia, headache, nausea, vasodilatation, burning sensation and dysgeusia.
L- aktar reazzjonijiet avversi komuni relatati mal- mediċina kienu ħakk, paresteżija, uġigħ ta ’ ras, dardir, vażodilatazzjoni, sensazzjoni ta ’ ħruq u indeboliment fis- sens tat- togħma.
Most of the undesirable effects were mild to moderate in intensity.
Il- biċċa l- kbira ta ’ l - effetti sekondarji kienu ta ’ intensità minn ħafifa sa moderata.
Most of the adverse reactions (80%) occurred within 2 hours.
Il- biċċa l- kbira tar- reazzjonijiet avversi (80%) seħħew fi żmien sagħtejn.
Delayed reactions (after hours to days) may occur.
Reazzjonijiet li jseħħu wara ċertu żmien (wara numru ta ’ sigħat jew ġranet) huma possibbli.
Clinical trial data Based on clinical trial experience in more than 1,800 patients, the following undesirable effects have been observed.
Tagħrif mill- provi kliniċi Ibbażat fuq esperjenza f’ aktar minn 1, 800 pazjent, l- effetti mhux mixtieqa li ġejjin ġew osservati.
The table below reports adverse reactions by MedDRA system organ classes (MedDRA SOCs).
It- tabella hawn taħt tirrapporta reazzjonijiet avversa bis- sistema tal- klassifika tal- organi MedDRA (MedDRA SOCs).
4 Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà ta ’ tagħhom.
System Organ Class (MedDra)
Sistema tal - Klassifika tal - Organi (MedDra) Infezzjonijiet u infestazzjonijiet Disturbi fis- sistema immuni
Common (≥ 1:100)
Komuni (≥ 1: 100)
Uncommon (≥ 1:
Mhux Komuni (≥ 1:
1,000 to < 1:
1, 000 sa < 1:
100)
100) Nasofarinġite Sensittività eċċessiva
Rare (≥ 1:
Rari (≥ 1:
10,000 to < 1:
10, 000 sa < 1:
Infections and infestations
1, 000) Ċellulite Infezzjoni ta ’ l- apparat ta ’ l- awrina
Nasopharyngitis
Disturbi fil -
Cellulitis Urinary tract infection
Ipergliċemija, Żbilanċ fl -
Immune system disorders
Iperkalimja
Hypersensitivity
metaboliżmu u n -
Metabolism and nutrition disorders
Elektroliti (inkl.
Hypocalcemia)
Ipokalimja
Psychiatric disorders
nutrizzjoni
Anxiety Confusion
Ipoklaċimja)
Hallucination Abnormal dreams
Ipernatrimja Tnaqqis fl- aptit
Headache Paraesthesia Dysgeusia Burning sensation
Ansjetà,
Dizziness (excl.
Alluċinazzjoni
Eye disorders
Konfużjoni
Vision abnormal Lacrimation increased
Ħolm mhux normali
Abnormal sensation in eye Asthenopia
Disturbi fis- sistema nervuża
Ear and labyrinth disorders
Uġigħ ta ’ ras, Paresteżija,
Ear pain
Sturdament (eskl.
Cardiac disorders
Disġewżja, Sensazzjoni ta ’ ħruq
Atrioventricular block first degree, Electrocardiogram QT prolonged, Tachycardia Electrocardiogram abnormal
Ipoesteżija, Parosomja, Aġewżja, Kontrazzjonijiet mhux volontarji tal- muskoli
Cardiac flutter Myocardial ischaemia Bradycardia Atrial fibrillation Palpitations Electrocardiogram ST segment depression, Electrocardiogram T wave amplitude decreased
Disturbi fl -
Vascular disorders
Viżjoni mhux normali
Vasodilatation (incl.
Sensazzjoni mhux
Phlebitis Hypertension Peripheral coldness
għajnejn Disturbi fil - widnejn u fis - sistema labirintika
Anaphylactoid reaction Hypotension Arteriosclerosis
Żjieda fid- dmugħ,
Respiratory, thoracic and mediastinal disorders
normali fl- għajn Astenopatija Uġigħ fil- widnejn
Dyspnea Cough
Disturbi fil- qalb
Respiratory depression
Imblukkar atrijoventrikolari
Gastrointestinal disorders
Flutter tal- qalb
Nausea
ta ’ l- ewwel grad.
Vomiting Retching
Iskemija mijokardjali Bradikardja Fibrillazzjoni atrijali Palpitazzjonijiet Depressjoni tas- segment ST ta ’ l - elettrokardjogramma, Amplitude tal- mewġa T mnaqqsa ta ’ l -
System Organ Class (MedDra)
Sistema tal - Klassifika tal - Organi (MedDra)
1,000)
Fwawar)
Diarrhea Abdominal pain Pharyngolaryngeal pain Abdominal discomfort Flatulence Hypoesthesia lips Salivary hypersecretion Dyspepsia Dry mouth Pruritus ani
Rimettar, Sforz biex tirremetti Dijarea, Uġigħ addominali, Uġigħ faringolarinġali, Skomdu addominali, Gass, Ipoesteżija fix- xuftejn, Sekrezzjoni eċċessiva tas - saliva, Dispepsja, Ħalq xott, Ħakk fl- anus
Skin and subcutaneous tissue disorders
fit- tessuti ta ’ taħt il- ġilda
Pruritus
Twaħħil
Urticaria Rash Erythema Sweating increased
Uġigħ fir- riġlejn,
Swelling face Clamminess
Egħbusija fil- muskoli
Musculoskeletal, connective tissue and bone disorders
skeltrali u tal - connective tissue
Pain in limb Neck pain Muscle cramps Muscle spasms
Uġigħ fl- għonq, Bugħawwieġ fil- muskoli, Spażmi fil- muskoli
Muscle tightness Sensation of heaviness
Sensazzjoni ta ’ toqol
Renal and urinary disorders
Uġigħ fil- kliewi Frekwenza ta ’ l- awrina
Haematuria, Microalbuminuria, Glycosuria
Disturbi fis- sistema riproduttiva u fis - sider
Micturition urgency Renal pain Urinary frequency
Ħakk ġenitali, Sensazzjoni ta ’ ħruq ġenitali
Reproductive system and breast disorders
Uġigħ, Uġigħ fis- sider,
Genital pruritus, Genital burning sensation
Uġigħ taħt żaqqek,
Pelvic pain
Debbulizza
General disorders Feeling cold and administration site conditions
Għeja, Tħosskok mhux normali, Tħoss is- sħana, Uġigħ fis- sit ta ’ l- injezzjoni Eritema fis- sit ta ’ l - injezzjoni Kesħa fis- sit ta ’ l- injezzjoni
Pain, Chest pain Groin pain Fatigue Feeling abnormal Feeling hot Injection site pain, Injection site erythema, Injection site coldness
Sensazzjoni ta ’ pressjoni fis- sider Trombożi fis- sit ta ’ l - injezzjoni Tbenġil fis- sit ta ’ l - injezzjoni Infjammazzjoni fis- sit ta ’ l- injezzjoni Ħruq fis- sit ta ’ l - injezzjoni Ekstravasazzjoni fis- sit
Pyrexia Rigors Weakness Chest pressure sensation Injection site thrombosis Injection site bruising Injection site inflammation Injection site burning Injection site extravasation Injection site haemorrhage Injection site pruritus Sensation of pressure
Sistema tal - Komuni Klassifika tal - (≥ 1: 100)
Injury and poisoning
Mhux Komuni (≥ 1:
Phantom limb pain
10, 000 sa < 1:
As with other intravenous contrast agents, this medicinal product can be associated with anaphylactoid / hypersensitivity reactions characterised by cutaneous, respiratory and/ or cardiovascular manifestations which may lead to shock.
Bħal sustanzi tal- kuntrast oħrajn li jingħataw ġol- vini, dan il- prodott mediċinali jista ’ jkun assoċjat ma ’ reazzjonijiet anafilattojdi / minħabba sensittività eċċessiva, li huma kkaratterizzati minn manifestazzjonijiet fil- ġilda, respiratorji u/ jew kardjovaskulari li jistgħu jwasslu għal xokk.
6 VASOVIST has been tested in humans up to a dose of 0.15 mmol/ kg (5 times the clinical dose).
VASOVIST kien ittestjat fil- bniedem sa doża ta ’ 0. 15 mmol/ kg (5 darbiet tad- doża klinika).
Clinical consequences of overdose with the medicinal product have not been reported.
Il - konsegwenzi kliniċi ta ’ doża eċċessiva bil- prodott mediċinali ma kienux irrappurtati.
Treatment for overdose should be directed toward the support of all vital functions and prompt institution of symptomatic therapy.
Il- kura għal doża eċċessiva għandha tkun diretta lejn l- appoġġ tal- funzjonijiet vitali kollha u bidu immedjat ta ’ terapija sintomatika.
Gadofosveset can effectively be removed from the body with high-flux dialysis (See section 5).
Gadofosveset jista ’ jitneħħa mill- ġisem b’ mod effettiv permezz ta ’ dijaliżi high- flux (Ara sezzjoni 5).
In the event of inadvertent overdose, the patient should be carefully observed including cardiac monitoring (see section 4.4).
F’ każ ta ’ doża eċċessiva li tittieħed bi żball, il- pazjent għandu jkun osservat bl- attenzjoni, inkluż il- monitoraġġ kardijaku (ara sezzjoni 4. 4).
Pharmacotherapeutic group: paramagnetic contrast media, ATC code:
Kategorija farmakoterapewtika: mediċina paramanjetika tal- kuntrast, Kodiċi ATC:
V08 C A VASOVIST is a formulation of a stable gadolinium diethylenetriaminepentaacetic acid (GdDTPA) chelate substituted with a diphenylcyclohexylphosphate group (gadofosveset trisodium), for use in magnetic resonance imaging (MRI).
V08 C A VASOVIST hu formulazzjoni ta ’ gadolinium diethylenetriaminepentaacetic acid (GdDTPA) chelate stabbli, sostitwit b’ grupp diphenylcyclohexylphosphate (gadofosveset trisodium), għall- użu fl - immaġni tar- reżonanza manjetika (MRI).
Gadofosveset binds reversibly to human serum albumin.
Gadofosveset jeħel b’ mod riversibbli ma ’ l- albumina tas- serum umana.
Protein binding enhances T1 relaxivity of gadofosveset up to 10 fold compared to non-protein bound gadolinium chelates.
It- twaħħil mal- proteina jtejjeb ir- rilassament tat- T1 ta ’ gadofosveset sa 10 darbiet iktar meta mqabbel ma ’ gadolinium chelates li mhumiex imwaħħlin mal- proteina.
In human studies, gadofosveset substantially shortens blood T1 values for up to 4 hours after intravenous bolus injection.
Fi studji fuq il- bniedem, gadofosveset iqassar b’ mod sostanzjali l - valuri T1 tad- demm sa 4 sigħat wara injezzjoni bolus ġol- vini.
Relaxivity in plasma was measured to be 33.4 to 45.7 mM-1s-1 over the dose range of up to 0.05 mmol/ kg at 20 MHz.
Ir- rilassament fil- plażma kien imkejjel li hu minn 33. 4 sa 45. 7 mM- 1s- 1 fil- medda tad- doża sa 0. 05 mmol/ kg f’ 20 MHz.
High resolution MRA scans of vascular structures are obtained up to one hour after administration of the medicinal product.
Skanns ta ’ l- MRA ta ’ riżoluzzjoni għolja ta ’ strutturi vaskulari jinkisbu sa siegħa wara l- għoti tal- prodott mediċinali.
The extended vascular imaging window for gadofosveset is attributed to enhanced relaxivity and extended residence in vascular space resulting from its plasma protein binding.
L - estensjoni fil- ħin li fih tista ’ tittieħed l- immaġni għal gadofosveset hi attribwita għar- rilassament imtejjeb u għar- residenza estiża fl- ispazju vaskulari li tirriżulta mit- twaħħil tiegħu mal- proteina tal - plażma.
No comparative studies with extracellular gadolinium contrast agents have been conducted.
Ma saru l- ebda studji komparattivi b’ sustanzi tal- kuntrast b’ gadolinium ekstraċellulari.
• Distribution The plasma concentration-time profile of intravenously administered gadofosveset conforms to a two- compartment open model.
• Distribuzzjoni Il- profil tal- konċentrazzjoni- żmien tal- plażma ta ’ gadofosveset mogħti ġol- vini hu konformi ma ’ mudell miftuħ b’ żewġ kompartimenti.
After intravenous administration of 0.03 mmol/ kg dose the mean half-life of the distribution phase (t1/ 2α) was 0.48 ± 0.11 hours and the volume of distribution at steady state was 148 ± 16 ml/ kg, roughly equivalent to that of extracellular fluid.
Wara l- għoti ġol- vini ta ’ doża ta ’ 0. 03 mmol/ kg, il- medja tal - half- life tal- fażi tad- distribuzzjoni (t1/ 2α) kienet ta ’ 0. 48 ± 0. 11 ta ’ siegħa u l- volum tad- distribuzzjoni fl- istat fiss kien ta ’ 148 ± 16 ml/ kg, bejn wieħed u ieħor ekwivalenti għal dak tal- fluwidu
Plasma protein binding was in a range 80% to 87% for up to the first 4 hours after injection.
It- twaħħil tal- plażma mal- proteina kien fil- medda ta ’ 80% sa 87% sa l- ewwel 4 sigħat wara l- injezzjoni.
• Metabolism The results from various evaluations of plasma and urine samples indicated that gadofosveset does not undergo measurable metabolism.
• Metaboliżmu Ir- riżultati minn evalwazzjonijiet varji ta ’ kampjuni tal- plażma u awrina jindikaw li gadofosveset ma jġarrabx metaboliżmu li jista ’ jitkejjel.
• Elimination In healthy volunteers, gadofosveset was predominantly eliminated in the urine with 84% (range 79 – 94%) of the injected dose (0.03 mmol/ kg) excreted in the urine in 14 days.
• Eliminazzjoni F’ voluntiera f’ saħħithom, gadofosveset kien predominantement eliminat fl- awrina b’ 84% (medda 79 – 94%) tad- doża injettata (0. 03 mmol/ kg) imneħħija fl- awrina f’ 14- il jum.
Ninety-four percent (94%) of the urinary excretion occurred in the first 72 hours.
Erba ’ u disgħin fil- mija (94%) tat- tneħħija urinarja seħħet matul l- ewwel 72 siegħa.
A small portion of gadofosveset dose was recovered in the faeces (4.7%, range 1.1 – 9.3%), indicating a minor role of biliary excretion in the disposition of gadofosveset.
Porzjon żgħir tad- doża ta ’ gadofosveset kien irkuprat fl- ippurgar (4. 7%, medda 1. 1 – 9. 3%), li jindika rwol żgħir tat- tneħħija mill- bila fid - dispożizzjoni ta ’ gadofosveset.
After intravenous administration of 0.03 mmol/ kg dose renal clearance (5.51 ± 0.85 ml/ h/ kg) and total clearance (6.57 ± 0.97 ml/ h/ kg) were similar, and mean terminal elimination half-life was 18.5 ± 3.0 hours.
Wara l- għoti ġol- vini ta ’ doża ta ’ 0. 03 mmol/ kg, it- tneħħija mill- kliewi (5. 51 ± 0. 85 ml/ h/ kg) u t- tneħħija totali (6. 57 ± 0. 97 ml/ h/ kg) kienu simili, u l- medja tal- half- life ta ’ l - eliminazzjoni terminali kienet ta ’ 18. 5 ± 3. 0 sigħat.
• Characteristics in patients
• Karatteristiċi fil- pazjenti Insuffiċjenza tal- kliewi:
In patients with moderate to severe renal impairment the half-life is markedly prolonged and the AUC increased by 2-3fold.
F’ pazjenti b’ indeboliment tal- kliewi minn moderat sa sever, il- half- life titwal b’ mod qawwi u l- AUC tiżdied minn 2 sa 3 darbiet iktar.
Hemodialysis patients:
Pazjenti bl- emodijaliżi:
7 Gadofosveset can be removed from the body by hemodialysis.
Gadofosvese jista ’ jitneħħa mill- ġisem bl- emodijaliżi.
After bolus intravenous administration of 0.05 mmol/ kg dose in patients requiring three times a week haemodialysis using high-flux filter, at the end of third dialysis session, the plasma concentration had declined to less than 15% of the Cmax.
Wara l- għoti ta ’ injezzjoni bolus ġol- vini ta ’ doża ta ’ 0. 05 mmol/ kg f’ pazjenti li jeħtieġu l- emodijaliżi tliet darbiet fil- ġimgħa bl- użu ta ’ filtru high - flux, fit- tmiem tat- tielet sessjoni tad- dijaliżi, il- konċentrazzjoni tal- plażma kienet naqset għal inqas minn 15% tas- Cmax.
During the dialysis sessions the mean half-life of plasma concentration decline was in the range 5-6 hours.
Waqt is- sessjonijiet tad- dijaliżi, il- medja tnaqqis tal- half- life tal- konċentrazzjoni tal- plażma kienet fil- medda ta ’ 5- 6 sigħat.
The mean dialysis clearance was between the range of 16 – 32 ml/ h/ kg.
Il- medja tat- tneħħija tad- dijaliżi kienet fil- medda ta ’ 16 – 32 ml/ h/ kg.
The high-flux dialysis filter was more efficient compared to the low-flux filter, therefore, use of a high-flux dialysis filter is recommended.
Id- dijaliżi permezz ta ’ filtru high- flux kienet aktar effiċjenti meta mqabbla ma ’ filtru low flux, u għalhekk l- użu ta ’ filtru high- flux tad- dijaliżi hu rakkomandat.
Plasma pharmacokinetics and protein binding of gadofosveset were not significantly influenced by moderate hepatic impairment (Child Pugh B).
Il- farmakokinetiċi tal- plażma u t- twaħħil mal- proteina ta ’ gadofosveset ma ’ kienux influwenzati b’ mod sinifikanti minn indeboliment moderat tal- fwied (Child Pugh B).
A slight decrease in faecal elimination of gadofosveset was seen for the hepatic impaired subjects (2.7%) compared to normal subjects (4.8%).
Tnaqqis żgħir fl- eliminazzjoni ta ’ gadofosveset ma ’ l- ippurgar kienet innutata f’ pazjenti b’ indeboliment tal- fwied (2. 7%) meta mqabbla ma ’ persuni normali (4. 8%).
In one subject with moderate hepatic impairment and abnormally low serum albumin, total clearance and half-life of gadofosveset was indicative of faster clearance compared to subjects with moderate hepatic impairment and normal serum albumin levels.
F’ pazjent wieħed li kellu indeboliment moderat tal- fwied u albumina tas- serum li kienet baxxa b’ mod anormali, it- tneħħija totali u l- half- life ta ’ gadofosveset kienu indikattivi ta ’ tneħħija iktar mgħaġġla meta mqabbla ma ’ pazjenti b’ indeboliment moderat tal - fwied u b’ livelli normali ta ’ albumina tas- serum.
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute toxicity, local tolerance, contact-sensitising potential, and genotoxicity.
Tagħrif ta ’ qabel l- użu kliniku bbażat fuq studji konvenzjonali dwar is- sigurtà farmakoloġika, it - tossiċità akuta, it- tolleranza lokali, il- potenzjal tas- sensibilizzazzjoni tal- kuntatt u l- ġenotossiċità, ma żvela l- ebda periklu speċjali għall- bnedmin.
Repeated dose toxicity Repeated-dose toxicity studies revealed vacuolation of the tubular cells of the kidneys, with strong evidence for reversibility of the effect.
Tossiċità ta ’ doża ripetuti Studji dwar it- tossiċità meta jingħataw dożi ripetuti żvelaw il- vakwolazzjoni taċ- ċelluli tubulari tal - kliewi, b’ evidenza qawwija għar- riversibbiltà ta ’ l- effett.
No functional impairment was observed and electron microscopic investigations of the rat kidneys indicated that the observed vacuolation was primarily a storage phenomenon.
L- ebda indeboliment funzjonali ma kien osservat, u investigazzjoni tal- kliewi tal- firien permezz ta ’ mikroskopju ta ’ l- elettroni, indikat li l - vakwolazzjoni osservata kienet primarjament fenomenu tal- ħażna.
Effects were of higher severity in rats than in monkeys, probably because of the higher renal clearance in rats.
L- effetti kienu iktar serji fil- firien milli fix- xadini, probabbilment minħabba t- tneħħija ogħla mill- kliewi fil- firien.
In monkeys, no renal effects were observed after single use even at a dose 100-times higher than the clinical dose.
Fix- xadini, ma kienu osservati l- ebda effetti fil- kliewi wara doża waħda, anki meta ngħatat doża li kienet 100 darba ogħla mid- doża klinika.
Reproduction toxicity In rabbits, an increased number of early resorptions and a slight but significant increase in the number of foetal anomalies (in particular hydrocephalus and malrotated limbs) were observed at dosages at which no or slight maternal toxicity was observed (exposure was 2 and 5 times the expected human exposure, respectively).
8 Tossiċità riproduttiva Fil- fniek, seħħ numru akbar ta ’ assorbimenti mill- ġdid bikrija, u żieda żgħira iżda sinifikanti fin - numru ta ’ anomaliji tal- fetu (b’ mod partikulari, idroċefalu u saqajn mhux imdawrin sewwa) kienu osservati f’ dożaġġi li fihom ma kienet osservata l- ebda tossiċità materna, jew fejn tossiċità materna ħafifa kienet osservata, (l- espożizzjoni kienet ta ’ 2 u 5 darbiet rispettivament ta ’ l- espożizzjoni umana mistennija).
Fosveset Sodium hydroxide Hydrochloric acid Water for injections
Fosveset Sodium hydroxide Hydrochloric acid Ilma għall- injezzjonijiet
After first opening: the medicinal product should be used immediately.
Wara li jinfetaħ għall- ewwel darba: il- prodott mediċinali għandu jintuża immedjatament.
Keep the injection vial in the outer carton in order to protect from light.
Żomm il- kunjett ta ’ l- injezzjoni fil- kartuna ta ’ barra biex tilqa ’ mid- dawl.
10 and 20 ml colourless type I glass vials with chloro- or bromobutyl elastomer stopper and aluminium bordered cap (plastic disk).
Kunjetti ta ’ 10 u 20 ml tal- ħġieġ tip I, mingħajr kulur, b’ għatu chloro - jew bromobutyl elastomer u b’ xifer ta ’ l- aluminju (diska tal- plastik).
1, 5, and 10 vials × 10 ml (in 10-ml glass vial) 1, 5, and 10 vials × 15 ml (in 20-ml glass vial) 1, 5, and 10 vials × 20 ml (in 20-ml glass vial)
Kunjetti ta ’ 1, 5 u 10 ml × 10 ml (f’ kunjett tal- ħġieg ta ’ 10 ml) Kunjetti ta ’ 1, 5 u 10 ml × 15 ml (f’ kunjett tal- ħġieg ta ’ 20 ml) Kunjetti ta ’ 1, 5 u 10 ml × 20 ml (f’ kunjett tal- ħġieg ta ’ 20 ml)
This medicinal product is supplied ready to use as a clear, colourless to pale yellow aqueous solution.
Dan il- prodott mediċinali huwa pprovdut lest għall- użu bħala soluzzjoni ċara, bla kulur sa safra ċara.
Contrast media should not be used in case of severe discolouration, the occurrence of particulate matter, or defective container.
Is- sustanzi tal- kuntrast m’ għandhomx jintużaw f’ każ ta ’ tibdil sever fil- kulur, jekk ikun fihom materjal f’ sura ta ’ partikuli, jew jekk il- kontenitur ikun difettuż.
Vials containing VASOVIST are not intended for the withdrawal of multiple doses.
Kunjetti li fihom VASOVIST mhumiex intenzjonati għall- ġbid ta ’ dożi multipli.
The rubber stopper should never be pierced more than once.
It- tapp tal- lastku m’ għandu qatt jittaqqab iktar minn darba.
After withdrawal of the solution from the vial, it should be used immediately.
Wara li s- soluzzjoni tinġibed mill- kunjett, din għandha tintuża minnufih.
Bayer Schering Pharma AG, D-13342 Berlin, Germany
Bayer Schering Pharma AG, D- 13342 Berlin, Il- Ġermanja
3 October 2005
3 t’ Ottubru, 2005
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DATA TA ’ META ĠIET RIVEDUTA L- KITBA
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS_ SUQ
Bayer Schering Pharma AG D – 13342 Berlin Germany
Bayer Schering Pharma AG D – 13342 Berlin Il- Ġermanja
Medicinal product subject to restricted medicinal prescription (See Annex 1:
Prodott mediċinali jingħata b’ riċetta ristretta tat- tabib (Ara Anness I:
VASOVIST 0.25 mmol/ ml, solution for injection
VASOVIST 0. 25 mmol/ ml soluzzjoni għall- injezzjoni.
1 ml of solution for injection contains 244 mg (0.25 mmol) of gadofosveset trisodium as active substance.
1 ml ta ’ soluzzjoni għall- injezzjoni fiha 244 mg (0. 25 mmol) ta ’ gadofosveset trisodium bħala s - sustanza attiva.
10 ml solution contains 2.44 g of gadofosveset trisodium in a vial.
Soluzzjoni ta ’ 10 ml fiha 2. 44 g ta ’ gadofosveset trisodium f’ kunjett.
20 ml solution contains 4.88 g of gadofosveset trisodium in a vial.
Soluzzjoni ta ’ 15 ml fiha 3. 66 g ta ’ gadofosveset trisodium f’ kunjett Soluzzjoni ta ’ 20 ml fiha 4. 88 g ta ’ gadofosveset trisodium f’ kunjett.
Excipients: fosveset, sodium hydroxide, hydrochloride acid, water for injections
Sustanzi mhux attiva: fosveset, sodium hydroxide, hydrochloride acid, ilma għall- injezzjonijiet
solution for injection 10 ml (1, 5, 10 vials) 15 ml (1, 5, 10 vials) 20 ml (1, 5, 10 vials)
soluzzjoni għll- injezzjoni 10 ml (1, 5, 10 kunjetti) 15 ml (1, 5, 10 kunjetti) 20 ml (1, 5, 10 kunjetti)
Intravenous use and diagnostic use only.
Għall- użu ġol- vini u użu dijanjostiku biss
Keep the injection vial in the outer carton in order to protect from light
Żomm il- kunjett ta ’ l- injezzjoni fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX
14 APPROPRIATE
15 UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
Discard any unused medium after each investigation.
Armi kull soluzzjoni mhux użata wara kull investigazzjoni.
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
EU/ 1/ 05/ 313/ 001 Vasovist-0.25 mmol/ ml-Solution for injection-Intravenous use-Vial (glass)-10 ml-1 vial EU/ 1/ 05/ 313/ 002 Vasovist-0.25 mmol/ ml-Solution for injection-Intravenous use-Vial (glass)-10ml-5 vials EU/ 1/ 05/ 313/ 003 Vasovist-0.25 mmol/ ml-Solution for injection-Intravenous use-Vial (glass)-10ml-10 vials EU/ 1/ 05/ 313/ 004 Vasovist-0.25 mmol/ ml-Solution for injection-Intravenous use-Vial (glass)-15ml-1 vial EU/ 1/ 05/ 313/ 005 Vasovist-0.25 mmol/ ml-Solution for injection-Intravenous use-Vial (glass)-15ml-5 vials EU/ 1/ 05/ 313/ 006 Vasovist-0.25 mmol/ ml-Solution for injection-Intravenous use-Vial (glass)-15ml-10 vials EU/ 1/ 05/ 313/ 007 Vasovist-0.25 mmol/ ml-Solution for injection-Intravenous use-Vial (glass)-20ml-1 vial EU/ 1/ 05/ 313/ 008 Vasovist-0.25 mmol/ ml-Solution for injection-Intravenous use-Vial (glass)-20ml-5 vials EU/ 1/ 05/ 313/ 009 Vasovist-0.25 mmol/ ml-Solution for injection-Intravenous use-Vial (glass)-20ml-10 vials
EU/ 1/ 05/ 313/ 001 Vasovist- 0. 25 mmol/ ml- Soluzzjoni għall- injezzjoni- Użu għal ġol- vini- Kunjett (ħġieġ) - 10 ml- 1 kunjett EU/ 1/ 05/ 313/ 002 Vasovist- 0. 25 mmol/ ml- Soluzzjoni għall- injezzjoni- Użu għal ġol- vini- Kunjett (ħġieġ) - 10 ml- 5 kunjetti EU/ 1/ 05/ 313/ 003 Vasovist- 0. 25 mmol/ ml- Soluzzjoni għall- injezzjoni- Użu għal ġol- vini- Kunjett (ħġieġ) - 10 ml- 10 kunjetti EU/ 1/ 05/ 313/ 004 Vasovist- 0. 25 mmol/ ml- Soluzzjoni għall- injezzjoni- Użu għal ġol- vini- Kunjett (ħġieġ) - 15 ml- 1 kunjett EU/ 1/ 05/ 313/ 005 Vasovist- 0. 25 mmol/ ml- Soluzzjoni għall- injezzjoni- Użu għal ġol- vini- Kunjett (ħġieġ) - 15 ml- 5 kunjetti EU/ 1/ 05/ 313/ 006 Vasovist- 0. 25 mmol/ ml- Soluzzjoni għall- injezzjoni- Użu għal ġol- vini- Kunjett (ħġieġ) - 15 ml- 10 kunjetti EU/ 1/ 05/ 313/ 007 Vasovist- 0. 25 mmol/ ml- Soluzzjoni għall- injezzjoni- Użu għal ġol- vini- Kunjett (ħġieġ) - 20 ml- 1 kunjett EU/ 1/ 05/ 313/ 008 Vasovist- 0. 25 mmol/ ml- Soluzzjoni għall- injezzjoni- Użu għal ġol- vini- Kunjett (ħġieġ) - 20 ml- 5 kunjetti EU/ 1/ 05/ 313/ 009 Vasovist- 0. 25 mmol/ ml- Soluzzjoni għall- injezzjoni- Użu għal ġol- vini- Kunjett (ħġieġ) - 20 ml- 10 kunjetti
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
16 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VASOVIST 0.25 mmol/ ml solution for injection Gadofosveset trisodium
VASOVIST 0. 25 mmol/ ml, soluzzjoni għall- injezzjoni Użu għal ġol- vini
< EXP {MM/YYYY} >
< JIS {XX/ SSSS} >
Lot{number}
Lott{ numru}
Vasovist 0.25 mmol/ ml, solution for injection Gadofosveset trisodium
Vasovist 0. 25 mmol/ ml, soluzzjoni għall- injezzjoni Gadofosveset trisodium
- If you have further questions, please ask the doctor giving you VASOVIST (the radiologist) or
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib li qed jagħtik VASOVIST (ir- radjologu) jew lill -
the hospital/ MRI-centre personnel
istaff ta ’ l- isptar/ ċentru ta ’ l- MRI.
please tell your doctor or radiologist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew radjologu tiegħek.
What VASOVIST is and what it is used for 2.
X’ inhu VASOVIST u għalxiex jintuża 2.
Before you are given VASOVIST 3.
Qabel ma tingħata VASOVIST 3.
How to use VASOVIST 4.
Kif għandek tuża VASOVIST 4.
How to store VASOVIST 6.
Effetti sekondarji li jista ’ jkollu 5 Kif taħżen VASOVIST 6.
WHAT VASOVIST IS AND WHAT IT IS USED FOR
X’ INHU VASOVIST U GĦALXIEX JINTUŻA
VASOVIST is an injectable contrast medium for making a diagnostic image of the body's blood vessels in the abdomen or limb clearer.
VASOVIST hu sustanza tal- kuntrast li tista ’ tkun injettata biex tagħmel immaġni dijanjostika tal- vini u l- arterji tal- ġisem fiż- żaqq jew fid- dirgħajn jew fir- riġlejn iktar ċara.
It is supplied as a ready-to-use solution packaged in a glass vial, in a strength of 250 micromole per millilitre.
Hu fornut bħala soluzzjoni lesta għall- użu ġo kunjett tal- ħġieġ, f’ doża li għandha qawwa ta ’ 250 mikromol għal kull millilitru.
Administration is by rapid injection into a vein (by a medical professional only).
L- għoti hu permezz ta ’ injezzjoni rapida ġo vina (minn biss professjonisti fil- qasam mediku).
VASOVIST is for diagnostic use only.
VASOVIST hu għal użu dijanjostiku biss.
It is used to help detect changes in the blood vessels which are known or suspected to be abnormal.
Jintuża sabiex jgħin jidentifika bidliet fl- arterji u fil- vini li hu magħruf, jew li hemm suspett, li huma anormali.
The diagnosis can be made with greater accuracy than without using this medicinal product.
Id- dijanjosi tista ’ ssir b’ iktar preċiżjoni milli mingħajr l- użu ta ’ dan il- prodott mediċinali.
VASOVIST, a contrast agent with magnetic properties, helps to visualize the passage of blood through the vessels by brightening the blood for an extended period.
VASOVIST, sustanza tal- kuntrast li għandha proprjetajiet manjetiċi, tgħin sabiex it- tnixxija tad- demm minn ġo l- arterji u l- vini tiġi viżwalizzata billi ddawwal id- demm għall- perjodu estiż ta ’ ħin.
This medicinal product is used together with an imaging technique called magnetic resonance imaging (MRI).
VASOVIST jintuża flimkien ma ’ teknika ta ’ l- immaġni li tissejjaħ immaġni tar- reżonanza manjetika (MRI).
If you have any questions or are not sure about something, ask the doctor or MRI-centre personnel.
Jekk ikollok xi mistoqsijiet, jew jekk m’ intix ċert/ a dwar xi ħaġa, staqsi lit- tabib jew lill- istaff taċ - ċentru ta ’ l- MRI.
BEFORE YOU ARE GIVEN VASOVIST
QABEL MA TINGĦATA VASOVIST
You must not be given VASOVIST if you have an allergy (hypersensitivity) to any of the ingredients of this medicinal product (see above).
Tużax VASOVIST: • M’ għandekx tingħata VASOVIST jekk inti allerġiku/ a (għandek sensittività eċċessiva) għal xi waħda mis- sustanzi ta ’ dan il- prodott mediċinali (ara hawn fuq).
You will need special medical attention if allergy-like reactions occur.
19 Oqgħod attent ħafna b’ VASOVIST: • Inti ser ikollok bżonn attenzjoni medika speċjali jekk reazzjonijiet bħal dawk ta ’ l- allerġija jseħħu.
Tell your doctor immediately if you notice itching, a feeling of mild swelling in your throat or tongue, which might be a first sign of some allergy-like reaction.
Għid lit- tabib tiegħek immedjatament jekk tinnota ħakk, tħoss nefħa ħafifa fil- gerżuma jew fl- ilsien, li jistgħu jkunu l- ewwel sinjal ta ’ xi reazzjoni bħal dik ta ’ l- allerġija.
Your doctor will be mindful of other signs as well.
It- tabib tiegħek ser joqgħod attent ukoll għal xi sinjali oħra.
Tell your doctor if: • you have a cardiac pacemaker or any ferromagnetic implant or a metallic stent in your body • you are pregnant or could be pregnant (that is, even if you are n't sure) • you suffer from allergy (e. g. hay fever, hives) or asthma • you had any reactions to previous injections of contrast media • your kidneys do not work properly
Għid lit- tabib tiegħek jekk: • għandek xi pacemaker kardijaku jew kwalunkwe impjant ferromanjetiku jew stent tal- metall f’ ġismek. • inti tqila jew jekk tista ’ tkun tqila (li jfisser, anki jekk m’ intix ċerta) • jekk tbati minn allerġija (eż. hay fever, urtikarja) jew ażżma • fil- passat kellek xi reazzjonijiet għal injezzjonijiet tas- sustanzi tal- kuntrast • il- kliewi tiegħek ma jaħdmux tajjeb
18 If any of these apply to you, your doctor will decide whether the intended examination is possible or not.
Jekk xi waħda minn dawn tapplika għalik, it- tabib tiegħek ser jiddeċiedi jekk l- eżami ppjanat huwiex possibbli jew le.
The safety of Vasovist in persons under 18 has not yet been tested.
Is- sigurtà ta ’ VASOVIST f’ persuni taħt it- 18- il sena għadha ma ġietx ittestjata.
Your doctor will advise you what to do.
It- tabib tiegħek ser jagħtik parir dwar x’ għandek tagħmel.
Pregnancy and breast-feeding Ask your doctor for advice before taking any medicine.
Tqala u Treddigħ Itlob il- parir tat- tabib tiegħek qabel tieħu xi mediċina.
It has not been proven that VASOVIST is safe to use during pregnancy.
Ma ġiex ippruvat li VASOVIST jista ’ jintuża mingħajr periklu waqt it- tqala.
Your doctor or radiologist will consider this with you.
It- tabib jew ir- radjologu tiegħek ser jiddiskutu dan miegħek.
This medicinal product must not be used in pregnant women unless strictly necessary.
Dan il- prodott mediċinali m’ għandux jintuża f’ nisa tqal ħlief jekk ikun strettament meħtieġ.
If you are breast-feeding, VASOVIST must not be used.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ VASOVIST
Important information about some of the ingredients of VASOVIST This medicinal product contains 6.3 mmol sodium (or 145 mg) per dose.
Dan il- prodott mediċinali fih 6. 3 mmol ta ’ sodium (jew 145 mg) kull doża.
To be taken into consideration by patients on a controlled sodium diet.
Biex jittieħed f’ kunsiderazzjoni minn pazjenti b’ dieta kkontrollata ta ’ sodium.
HOW TO USE VASOVIST
KIF JINTUŻA VASOVIST
You will be asked to lie down on the MRI scanning bed.
Inti ser tintalab biex timtedd fuq is- sodda ta ’ l- iskannjar tal- MRI.
This medicinal product is administered by injection into a vein.
Dan il- prodott mediċinali jingħata permezz ta ’ injezzjoni ġo vina.
The usual injection site is the back of your hand or just in front of your elbow.
Il- post normali ta ’ l- injezzjoni huwa n- naħa ta ’ wara ta ’ idejk jew appena fuq quddiem tal- minkeb.
Scanning may start immediately after the VASOVIST injection.
L- iskannjar jista ’ jinbeda immedjatament wara l- injezzjoni ta ’ VASOVIST.
After the injection you will be observed in case there might be any initial side effects.
Wara l- injezzjoni inti ser tkun osservat/ a fil- każ li jkun hemm xi effetti sekondarji inizjali.
The dose of this medicinal product varies depending on your weight.
Id- doża ta ’ dan il- prodott mediċinali tvarja skond il- piż tiegħek.
The doctor will decide how much VASOVIST is needed for your examination. The dosage is:
It- tabib ser jiddeċiedi l- ammont meħtieġ ta ’ VASOVIST għall- eżami tiegħek.
Further information regarding the administration and handling of VASOVIST is given at the end of the leaflet.
0. 12 ml/ kg ta ’ piż tal- ġisem (ekwivalenti għal 0. 03 mmol/ kg ta ’ piż tal- ġisem) Aktar tagħrif dwar l- għoti u l- immaniġġjar ta ’ VASOVIST jingħata fl- aħħar tal- fuljett.
If you receive more VASOVIST than you should have received:
Jekk tirċievi aktar VASOVIST minn dak li suppost irċivejt:
Overdosing is highly unlikely, but your doctor will know what to do if it should occur.
Doża eċċessiva x’ aktarx li mhix ser isseħħ, iżda t- tabib tiegħek ser ikun jaf x’ għandu jagħmel jekk dan iseħħ.
If necessary, VASOVIST can be removed from the body by haemodialysis using high-flux filters.
Jekk ikun meħtieġ, VASOVIST jista ’ jitneħħa mill- ġisem permezz ta ’ emodijaliżi high- flux.
If you have any further questions on the use of this product, please consult your doctor, the radiologist or MRI-centre personnel.
20 Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, jekk jogħġbok staqsi lit- tabib, radjoloġista jew ħaddiem taċ- ċentru MRI tiegħek.
POSSIBLE SIDE EFFECTS
EFFETTI SEKONDARJI LI JISTGĦU JINĦASSU
Like all medicines, VASOVIST can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, VASOVIST jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Itching, tingling or numbness of the hands or feet, headache, nausea, warm feeling (vasodilatation), burning sensation, and change of taste in the mouth (dysgeusia) are the most frequently reported side effects.
Ħakk, tnemnim jew nuqqas fis- sens tal- mess ta ’ l- idejn u s- saqajn, uġigħ ta ’ ras, dardir, tħoss is- sħana (vażodilatazzjoni), sensazzjoni ta ’ ħruq, u tibdil fis- sens tat- togħma fil- ħalq (dysgeusia) huma l- aktar effetti sekondarji li jiġu rrappurtati.
Most of the undesirable effects were mild to moderate in intensity.
Il- biċċa l- kbira ta ’ l- effetti sekondarji kienu ta ’ intensità minn ħafifa sa moderata.
Most of the adverse reactions (80%) occurred within 2 hours.
Il- biċċa l- kbira tar - reazzjonijiet avversi (80%) seħħew fi żmien sagħtejn.
Below we list the reported/ experienced side effects by frequency:
Isfel inniżżlu l- effetti sekondarji rrappurtati/ esperjenzati skond il- frekwenza:
19 Common reported side effects (likely to occur in fewer than 1 in 10 patients).
Effetti sekondarji rrappurtati b’ mod komuni (probabbli li jseħħu f’ inqas minn 1 kull 10 pazjenti).
Uncommon side effects (likely to occur in fewer than 1 in 100 patients).
Effetti sekondarji rrappurtati b’ mod mhux komuni (probabbli li jseħħu f’ inqas minn 1 kull 100 pazjenti).
Rare side effects (likely to occur in fewer than 1 in 1000 patients).
Effetti sekondarji rrappurtati b’ mod rari (probabbli li jseħħu f’ inqas minn 1 kull 1000 pazjenti).
The following is a list of side-effects observed in clinical trials:
Li ġej hija lista ta ’ effetti sekondarji osservati fil- provi kliniċi:
Infections and infestations (no effects were found to be common); uncommon: runny nose, sore throat; rare: inflammation of the skin, urinary tract infection.
Infezzjonijiet u infestazzjonijiet (ma nstabu l- ebda effetti li kienu komuni); mhux komuni: imnieħer inixxi, uġigħ fil- griżmejn, rari: infezzjoni tal- ġilda, infezzjoni fl- apparat urinarju.
Immune system disorders (no effects were found to be common or rare); uncommon: allergy-like reaction.
Disturbi fis- sistema immunitarja (ma nstabu l- ebda effetti li kienu komuni jew rari) mhux komuni: reazzjoni bħal dik ta ’ l- allerġija.
Metabolism and nutrition disorders (no effects were found to be common); uncommon: high sugar levels in the blood, low calcium levels in the blood, unusual amount of salt in the body; rare: low potassium levels in the blood, high potassium levels in the blood, high sodium levels in the blood, appetite decreased.
Disturbi fil- metaboliżmu u n- nutrizzjoni (ma nstabu l- ebda effetti li kienu komuni); mhux komuni: livell għoli ta ’ zokkor fid- demm, livelli baxxi ta ’ kalċju fid- demm, ammont mhux tas- soltu ta ’ melħ fil- ġisem; rari: livelli baxxi ta ’ potassju fid- demm, livelli għolja ta ’ potassju fid- demm, livelli għoli ta ’ sodju fid- demm, nuqqas t’ aptit.
Psychiatric disorders (no effects were found to be common); uncommon: feeling anxious, confusion; rare: seeing, feeling or hearing things that are not there; abnormal dreams.
Disturbi psikjatriċi (ma nstabu l- ebda effetti li kienu komuni); mhux komuni: tħossok ansjuż, konfużjoni; rari: tara, tħoss jew tisma ’ affarijiet li mhumiex hemm; ħolm anormali.
Nervous system; common: headache; tingling or numbness of the hands or feet; change of taste in mouth, burning sensation; uncommon: impairment of taste, dizziness, tremors, decreased feeling or sensitivity (especially of the skin), sense of smell distortion, involuntary muscle contractions.
Sistema nervuża, komuni: uġigħ ta ’ ras, tnemnim jew nuqqas fis- sens tal- mess ta ’ l- idejn u s- saqajn; tibdil fis- sens tat- togħma fil- ħalq, sensazzjoni ta ’ ħruq; mhux komuni: indeboliment fis- sens tat - togħma, sturdament, rogħda, nuqqas fis- sens tal- mess jew fis- sensittività (speċjalment tal- ġilda), tibdil fis- sens tax- xamm, kontrazzjonijiet involuntarji tal- muskoli.
Eye (no effects were found to be common); uncommon: abnormal vision, tear secretion increased; rare: eyesight disorders, abnormal eye sensation.
Għajnejn (ma nstabu l- ebda effetti li kienu komuni); mhux komuni: vista mhux normali, żieda fil - produzzjoni tad- dmugħ; rari: problemi tal- viżta, sensazzjoni anormali fl- għajnejn.
Ear (no effects were found to be common or uncommon); rare: ear pain.
Widnejn (ma nstabu l- ebda effetti li kienu komuni jew mhux komuni); rari: uġigħ fil- widnejn.