qanastek/EMEA-V3 huggingface dataset:
The safety of repeat doses has not been established in children and adolescents, in patients with impaired renal function, 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 0.3 mmol/ 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 ’ 0. 3 mmol/ kg 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 kinitx studjata fil- grupp ta ’ din l- età.
Insertion of a flexible in-dwelling venous catheter is recommended.
L- inserzjoni ta ’ kateter venuż in- dwelling flessibbli hu rakkomandat.
40 Interaction with other medicinal products and other forms of interaction No formal interaction studies have been performed.
Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l - effett farmaċewtiku tal- prodott Ma sarux l- ebda studji formali dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott.
Gadoversetamide has been shown to cause interference in the measurement of serum calcium using the ortho-cresolphthalein complexone (OCP) colorimetric method.
Intwera li Gadoversetamide jikkawża interferenza fil- kejl tal- calcium fis- serum bl- użu tal- metodu kolorimetriku ortho- cresolphthalein complexone (OCP).
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 żbaljata għall- calcium fil- plażma.
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.
Special precautions for disposal and other handling Optimark is intended for single use only; any unused portions should be discarded.
Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor Optimark hu intenzjonat biex jintuża darba biss; kwalunkwe porzjonijiet li ma jintużawx għandhom jintremew.
Optimark pre-filled syringes should be used immediately.
Optimark siringi mimlijin għal- lest għandhom jintużaw immedjatament.
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 ikun idur b’ mod ħieles.
Prior to using the syringe, twist off grey tip cap and discard.
43 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 mat- tubu ta ’ l - infużjoni.
41 PACKAGE LEAFLET:
44 FULJETT TA ’ TAGĦRIF:
WHAT Optimark IS AND WHAT IT IS USED FOR
X’ INHU Optimark U GĦALXIEX JINTUŻA
This medicine is for diagnostic use only.
Din il- mediċina hi għall- użu dijanjostiku biss.
Tell your doctor, if:  you suffer from allergies (e. g. medicinal products, seafood, hay fever, hives) or asthma  you had any reactions to previous injections of a contrast agent, including a previous history of reaction to iodine-based contrast agents  your kidneys do not work properly  Optimark is planned to be used in your child which is below the age of two years
Prodotti mediċinali, frott tal- baħar, hay fever, urtikarja) jew ażżma  kellek xi reazzjonijiet għal injezzjonijiet ta ’ sustanza tal- kuntrast fil- passat, li tinkludi b’ passat mediku medika ta ’ reazzjoni għal sustanzi tal- kuntrast ibbażati fuq l- iodine  il- kliewi tieghek ma jiffunzjonawx tajjeb  Optimark hu ppjanat li jintuża fit- tifel/ tifla tiegħek li għandu/ għandha inqas minn sentejn
42 Tell your doctor, if:  you are feeling thirsty and/ or if you have only had small quantities or nothing to drink before the examination  you have a cardiac pacemaker or any ferromagnetic implant (vascular clips, etc.) or a metallic stent in your body  you are taking a special kind of antihypertensive medicine, i. e. a beta-blocker  you have heart disease  you suffer from epilepsy or brain lesions  you are or your child is on a controlled sodium diet If any of these apply to you, your doctor will decide whether the intended examination is possible or not.
45 Għid lit- tabib tiegħek jekk:  tħossok bil- għatx u/ jew jekk kellek biss kwantitajiet żgħar jew xejn x’ tixrob qabel l- eżami  għandek pacemaker kardijaku jew kwalunkwe impjant ferromanjetiku (klipps vaskulari, eċċ.) jew stent tal- metall f’ ġismek  qed tieħu tip speċjali ta ’ mediċina kontra l- pressjoni għolja, i. e. imblokkatur tar- riċetturi beta  għandek mard tal- qalb  tbati minn epilessija jew leżjonijiet fil- moħħ  int jew it- tifel/ tifla tkun fuq dieta kkontrollata tas- sodium Jekk xi waħda minn dawn tapplika għalik, it- tabib tiegħek ser jiddeċiedi jekk l- eżami ppjanat huwiex possibbli jew le.
Important information about some of the ingredients of Optimark This medicine contains less than 1 mmol sodium (23 mg) per dose of up to 17 ml, i. e. essentially ‘ sodium- free’.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Optimark Din il- mediċina fiha inqas minn 1 mmol ta ’ sodium (23 mg) f’ kull doża sa massimu ta ’ 17 ml, jiġifieri hu essenzjalment ‘ ħieles mis- sodium ’.
The usual dose The usual dose is about 14 ml injected over about 7 -14 seconds into a vein, usually a vein in an arm.
Id- doża normali Id- doża normali hi ta ’ madwar 14 ml injettati fuq perjodu ta ’ madwar 7 – 14- il sekonda ġo vina, normalment vina fid- driegħ.
The injection is then flushed through with a saline injection to make sure none is left in the needle or tube used for the injection.
L- injezzjoni tkun imbagħad segwita b’ injezzjoni ta ’ salina biex tiżgura li ma jibqa ’ xejn fil- labra jew it- tubu li jintużaw għal- injezzjoni.
Certain questions regarding treatment of a brain disease may require the injection of three times the usual dose in one injection.
Ċerti mistoqsijiet dwar il- kura ta ’ mard fil- moħħ jista ’ jkollhom bżonn l- injezzjoni ta ’ tliet darbiet l- ammont ta ’ doża normali li jkun hemm injezzjoni waħda.
Immediately tell the doctor or nurse/ technologist who is giving you the injection, if you feel unwell, especially if you feel any tightness, pain or discomfort in your chest, face or throat, or you have difficulty breathing.
Immedjatament għid lit- tabib jew ners/ teknoloġista li jkunu qed jagħtuk l- injezzjoni, jekk ma tħossokx tajjeb/ tajba, speċjalment jekk tħoss kwalunkwe tagħfis, uġigħ jew skonfort f’ sidrek, f’ wiċċek jew fil - gerżuma, jew jekk ikollok diffikultà biex tieħu n- nifs.
Possible side effects are described in greater detail below.
L- effetti sekondarji possibbli huma deskritti f’ aktar dettall hawn taħt (ara sezzjoni 4).
The majority of adverse reactions observed after the use of Optimark were found to be adverse reactions of the nervous system, followed by general adverse reactions, digestive tract disorders/ skin disorders.
Il- maġġoranza tar- reazzjonijiet avversi li kienu osservati wara l- użu ta ’ Optimark instabu li kienu reazzjonijiet avversi tas- sistema nervuża, segwiti minn reazzjonijiet avversi ġenerali, disturbi fil - passaġġ tad- digestjoni/ disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda.
The frequencies below and the following symptoms are based on clinical trials, and on the experience in using Optimark after it was on the market:
Il- frekwenzi t’ hawn taħt u s- sintomi li ġejjin huma bbażati fuq provi kliniċi, u fuq l- esperjenza bl- użu ta ’ Optimark wara li t- tqegħid fis- suq:
very common: common: uncommon: rare: very rare:
komuni ħafna: komuni: mhux komuni:
In more than 1 of 10 treated patients In less than 1 of 10, but more than 1 of 100 treated patients In less than 1 of 100, but more than 1 of 1,000 treated patients In less than 1 of 1,000, but more than 1 of 10,000 treated patients In 1 case or less of 10,000 treated patients including isolated reports
f’ iktar minn 1 minn kull 10 pazjenti kkurati f’ inqas minn 1 minn kull 10, iżda f’ iktar minn 1 minn kull 100 pazjent ikkurat f’ inqas minn 1 minn kull 100, iżda f’ iktar minn 1 minn kull 1, 000 pazjent ikkurat
decreased appetite, feeling anxious, sleep disorder, fainting, shaking, drowsy feeling, burning sensation, ringing in the ears, eyelid redness, eye pain, vision blurred, fast heart beat, awareness of the heartbeat, irregular heartbeats, extra heartbeats, low blood pressure, high blood pressure, shortness of breath, hoarseness, cough, runny nose, throat constriction, mouth watering, vomiting, abdominal pain, constipation, dry mouth, cold sweat, redness, sweating, higher blood level of a substance (creatinine) usually eliminated by the kidneys, blood in urine, chest pain, face swollen, fatigue, fever, swelling in limbs, pain, cold feeling in extremities, liver enzyme increased, urine analysis abnormal, mineral values in urine increased, heart and muscle enzyme increased, decreased haemoglobin, changes in blood calcium levels
Effetti sekondarji li jista ’ jkollu sturdament, uġigħ ta ’ ras, togħma stramba f’ ħalqek, tħoss is- sħana reazzjoni allerġika/ sensittività eċċessiva, sensazzjoni ta ’ tnemnim, tmewwit, sens tax - xamm imnaqqas, il- ġilda tkun ħamra u taħraq, konġestjoni nażali, uġigħ fil- griżmejn, dardir, dijarea, urtikarja, ħakk, raxx, skonfort fis- sider, tħoss il- bard, reazzjonijiet fis- sit ta ’ l- għoti nuqqas t’ aptit, tħossok anzjuż, problemi biex torqod, iħossok ħażin, rogħda, tħossok bi ngħas, sensazzjoni ta ’ ħruq, tisfir fil- widnejn, ħmura f’ tebqet il- għajn, uġigħ fl - għajnejn, vista mċajpra, taħbit tal- qalb mgħaġġel, tħossok konxju tat- taħbit tal- qalb, taħbit tal- qalb irregolari, taħbit tal- qalb addizzjonali, pressjoni tad- demm baxxa, pressjoni tad- demm għolja, qtugħ ta ’ nifs, tinħanaq, sogħla, imnieħer inixxi, restrizzjoni fil- gerżuma, żieda tal- bżieq fil- ħalq, rimettar, uġigħ ta ’ żaqq, stitikezza, ħalq xott, għaraq kiesaħ, ħmura, għaraq, livell ogħla fid- demm ta ’ sustanza (kreatinina) li normalment tkun eliminata mill- kliewi, demm fl- awrina, uġigħ fis- sider, wiċċ minfuħ, għeja kbira, deni, nefħa fid- dirgħajn/ riġlejn, uġigħ, sensazzjoni ta ’ kesħa fl - estremitajiet, żieda fl- enzimi fil- fwied, analiżi anormali ta ’ l- awrina, żieda fil- figuri tal - minerali fl- awrina, żieda fl- enzimi fil- qalb u fil- muskoli, tnaqqis fl- emoglobina, bidliet fil- livelli tal- calcium fid- demm
Feeling confused, convulsion, bloodshot eyes, heart beat irregularities, tightening of the airways, swollen throat or vocal cords, raw throat, itchy nose, sneezing, swelling around the eyes, flu-like symptoms, feeling unwell, problems with the electrical rhythm of the heart (long QT)
Nefħa madwar l- għajnejn, sintomi bħal ta ’ l- influwenza, ma tħossokx tajjeb, problemi fir- rittmu elettriku tal- qalb (QT twil)
Cases of abnormalities of the skin including thickening/ inflammation or fibrosis (NSF) have been reported.
Każijiet ta ’ anormalitajiet tal- ġilda li jinkludu li l- ġilda teħxien/ tinfjamma jew fibrożi (NSF) kienu rrappurtati.
You must report any of the following symptoms immediately to the doctor or nurse/ technologist, and get immediate treatment as they can be or can become very serious: side effects affecting the heart (fainting, extra heart beats, chest pain) or the respiratory system (shortness of breath, tightening of the airways, swollen or tight throat, itchy or runny nose, sneezing).
Effetti sekondarji li jaffettwaw il- qalb (ħass ħażin, taħbit tal- qalb addizzjonali, uġigħ fis - sider) jew is- sistema respiratorja (qtugħ ta ’ nifs, il- passaġġi tan- nifs jidjiequ, gerżuma minfuħa jew tħossha dejqa, ħakk fl- imnieħer jew imnieħer inixxi, għatis).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Għandek tirrapporta kwalunkwe wieħed minn dawn is- sintomi immedjatament lit- tabib jew lin - ners/ teknoloġista, u tikseb kura immedjata, għax dawn jistgħu jkunu severi ħafna.
Keep the vial in the outer carton in order to protect from light.
Żomm il- kunjetti fil- kartuna ta ’ barra biex tilqa ’ mid- dawl.
 The active substance is gadoversetamide.
X’ fih Optimark  Is- sustanza attiva hi gadoversetamide.
1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromoles.  The other ingredients are: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/ or hydrochloric acid, water for injections.
1 ml fih 330. 9 mg ta ’ gadoversetamide, ekwivalenti għal 500 mikromol.  Is- sustanza l- oħra huma: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide u/ jew hydrochloric acid, ilma għall- injezzjonijiet.
Optimark vials contain a clear, colourless to pale yellow solution.
Id- dehra ta ’ Optimark u d- daqs tal- pakkett Il- kunjetti Optimark fihom soluzzjoni ċara, bla kulur jew ta ’ kulur isfar ċar.
Optimark is supplied in vials, fitted with bromobutyl rubber closures and aluminium cap seals.
Optimark hu fornuti f’ kunjetti, mgħammra b’ għatjien tal- lastku tal- bromobutyl u siġilli ta ’ l- għatu ta ’ l- aluminju.
Optimark vials are supplied in the following package sizes:
Il- kunjetti Optimark huma fornuti fid- daqsijiet tal- pakkett li ġejjin:
1 x 10 ml 10 x 10 ml 1 x 15 ml 10 x 15 ml 1 x 20 ml 10 x 20 ml Not all package sizes may be marketed.
1 x 10 ml 10 x 10 ml 1 x 15 ml 10 x 15 ml 1 x 20 ml 10 x 20 ml Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Optimark is also available in pre-filled syringes of 10 ml, 15 ml, 20 ml and 30 ml.
Optimark hu wkoll disponibbli siringi mimlijin għal- lest ta ’ 10 ml, 15 ml, 20 ml u 30 ml.
Marketing Authorisation Holder For any information about this medicine, please contact the Marketing Authorisation Holder:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lid- detentur ta ’ l - awtorizzazzjoni għat- tqegħid fis- suq:
Covidien Deutschland GmbH Gewerbepark 1 93333 Neustadt/ Donau Germany
48 Covidien Deutschland GmbH Gewerbepark 1 93333 Neustadt/ Donau Il- Ġermanja
Detailed information on this product is available on the European Medicines Agency (EMEA) web site http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - mediċini (EMEA) http: // www. emea. europa. eu
45 The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
Therapeutic indications Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver.
Indikazzjonijiet terapewtiċi Optimark hu indikat għall- użu ma ’ l- istrument ta ’ l- immaġni bir- riżonanza manjetika MRI tas- sistema nervuża ċentrali CNS u l- fwied.
It provides contrast enhancement and facilitates visualization and helps with characterization of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology.
Jipprovdi titjib tal- kuntrast u jiffaċilita l- viżwalizzazzjoni u jgħin fil - karatterizzazzjoni tal- leżjonijiet fokali u strutturi anormali fis- CNS u fil- fwied f’ pazjenti b’ patoloġija magħrufa jew issuspettata b’ mod qawwi.
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, imtejba bil- kuntrast fl- assenza ta ’ MRI oħra mhux imtejba.
The usual contraindications of MR examinations must be applied, such as exclusion of patients with infusion pumps, pacemakers, ferro-magnetic clips etc.  Hypersensitivity Allergoid and other idiosyncratic reactions may occur with all contrast media for intravenous application, also with gadoversetamide, which could become manifest in form of cardiovascular, respiratory and skin reactions.
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.  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.
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.
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
Premedication with antihistamines and/ or glucocorticoids may be considered.  Patients taking beta-blockers It should be noted that patients using beta-blockers do not necessarily respond to the beta-agonists usually used for the treatment of hypersensitivity reactions.  Patients with cardiovascular disease In this group of patients hypersensitivity reactions may be severe.
Tista ’ tiġi kkunsidrata l- medikazzjoni minn qabel b’ antistamini u/ jew glukokortikojdi.  Pazjenti li qed jieħdu imblokkaturi tar- riċetturi beta Għandu jkun innutat li pazjenti li 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.
46 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.
Posology and method of administration The agent should be administered as a bolus peripheral intravenous injection at a dose of 0.2 ml/ kg (0.1 mmol/ kg) body weight.
50 Is- sustanza għandha tingħata bħala injezzjoni ġol- vina periferali bolus f’ doża ta ’ 0. 2 ml/ kg (100 mikromol/ kg) ta ’ 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 0.1 mmol/ kg may be administered within 30 minutes of the first injection as it may increase the diagnostic yield of the examination.
F’ MRI kranjali, jekk jippersisti suspett kliniku qawwi b’ saħħtu ta ’ leżjoni, minkejja doża waħda ta ’ MRI bil- kuntrast imtejjeb, jew fejn informazzjoni aktar preċiża dwar in- numru, id- daqs jew il- firxa tal - leżjonijiet tista ’ tinfluwenza l- immanniġġjar jew it- terapija tal- pazjent, f’ persuni b’ funzjoni normali tal- kliewi, tista ’ tingħata t- tieni injezzjoni bolus ta ’ 0. 1 mmol/ kg sa 30 minuta mill- ewwel injezzjoni peress li dan jista ’ jtejjeb ir- riżultat dijanjostiku ta ’ l- eżami.
Optimark is not recommended for use in children below the age of two years because the safety, efficacy, and impact of immature kidney function have not been studied in this age group.
Optimark mhux irrakkomandat għall- użu fit- tfal ta ’ taħt l- età ta ’ sentejn minħabba li s- sigurtà, effikaċja u l- impatt ta ’ funzjoni immatura tal- kliewi ma kinitx studjata f’ 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.
47 Interaction with other medicinal products and other forms of interaction No formal interaction studies have been performed.
Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l - effett farmaċewtiku tal- prodott Ma sarux l- ebda studji formali dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott.
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.
The product must be examined before use to confirm that all solids are dissolved and that the container and closure are un-damaged.
Il- prodott irid ikun eżaminat qabel l- użu biex tikkonferma li s- solidi kollha jkunu nħallu u li l - kontenitur u l- għatu ma jkunx fihom ħsara.
EU Numbers
Kontenut Numru ta ’ l- EU
Package sizes
Daqs tal- pakkett
EU/ 1/ 98/ 065/ 001
EU/ I/ 98/ 065/ 001
Dispersion for injection
Dispersjoni għall- injezzjoni
Intravenous use
Użu għal - ġol- vini
Vial (glass)
Kunjett (ħafna)
1 vial
1 Kunjett
EU/ 1/ 98/ 065/ 002
EU/ I/ 98/ 065/ 002
OPTISON 0.19 mg/ ml dispersion for injection
OPTISON 0. 19, dispersjoni għall- injezzjoni
OPTISON consists of perflutren-containing microspheres of heat treated human albumin, suspended in human albumin solution, 1%.
OPTISON jikkonsisti f' mikrosferi ta 'l- albumina tal- bniedem ittrattati bis- sħana li fihom perflutren, jgħum f' soluzzjoni ta' albumina tal- bniedem, 1%
Perflutren -containing microspheres, 5-8 x 108/ ml with a mean diameter range of 2.5 - 4.5 µm.
Konċentrazzjoni: mikrosferi li fihom Perflutren, 5- 8 x 108/ ml b' medja ta 'dijametru fil- limiti ta ’ bejn 2. 5 u 4. 5 µm.
The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg.
L- ammont ta 'gass ta' perflutren f' kull ml ta 'OPTISON huwa bejn wieħed u ieħor 0. 19 mg.
Excipient Each ml contains 0.15 mmol (3.45 mg) of sodium.
Sustanza mhux attiva Kull ml fih 0. 15 mmol (3. 45 mg) ta ’ sodium.
Dispersion for injection.
Dispersjoni għall- injezzjoni.
Clear solution with white microsphere layer on top.
Soluzzjoni ċara b’ saff ta ’ mikrosferi bojod fin- naħa ta ’ fuq.
OPTISON is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left ventricular endocardial border delineation with resulting improvement in wall motion visualisation.
OPTISON huwa sustanza għall- kuntrast fl- ekokardjografiji tal- pulmun u jintuża f' pazjenti fejn hemm suspett jew prova ta 'mard tal- qalb biex iċajpar l- kompartimenti tal- qalb, biex toħroġ aktar ċara l - bordura endokardjali ventrikulari tax- xellug u għalhekk iċ- ċaqlieq tal- ħajt ikun jista' jidher aħjar.
OPTISON should only be used in patients where the study without contrast enhancement is inconclusive.
OPTISON għandu jintuża biss f’ pazjenti fejn l- istudju mingħajr it- titjib tal- kuntrast mhux konklussiv.
OPTISON should only be administered by physicians experienced in the field of diagnostic ultrasound imaging.
OPTISON għandu jingħata biss minn tobba b' esperjenza fil- qasam tal- viżjoni bl- ultrasawnd għad - dijanjożi.
Before administering OPTISON, please see section 6.6 for instructions for use/ handling.
Qabel ma jingħata l- OPTISON, jekk jogħġbok ara taqsima 6. 6 għal struzzjonijiet ta 'użu/ maniġġjar.
This medicinal product is intended for left ventricular opacification after intravenous administration.
Dan il- prodott mediċinali huwa maħsub biex iċajpar il- ventrikuli tax- xellug wara li jingħata fil- vina.
Ultrasound imaging must be performed during injection of OPTISON as optimal contrast effect is obtained immediately after administration.
Il- viżjoni bl- ultrasawnd trid issir waqt l- injezzjoni ta 'OPTISON billi l- aħjar effett ta' kuntrast joħroġ eżatt wara li jingħata.
Dosage The recommended dose is 0.5 ml - 3.0 ml per patient.
Dożaġġ Il- doża rakkomandata hija 0. 5 ml - 3. 0 ml għal kull pazjent.
A dose of 3.0 ml is usually sufficient, but some patients may need higher doses.
Ġeneralment, doża ta '3. 0 ml tkun biżżejjed, imma xi pazjenti jista' jkollhom bżonn dożi ogħla.
The duration of
Id- doża totali m' għandhiex tkun iktar minn 8. 7 ml kull pazjent.
2 the useful imaging time is 2.5 - 4.5 minutes for a dose of 0.5 - 3.0 ml.
It- tul ta ’ ħin, li hemm bżonn għal viżjoni huwa 2. 5 - 4. 5 minuti għal doża ta '0. 5 - 3. 0 ml.
OPTISON could be repeatedly administered, however, the clinical experience is limited.
OPTISON jista 'jerġa' jingħata, iżda l- esperjenza klinika hija limitata.
Paediatric patients OPTISON is not recommended for use in children below 18 years due to lack of data on safety and efficacy.
Pazjenti pedjatriċi OPTISON mhux irrakkomandat għall- użu fit- tfal taħt it- 18- il sena minħabba nuqqas ta ’ informazzjoni dwar is- sigurtà u l- effikaċja.
Pulmonary hypertension with a systolic pulmonary artery pressure > 90 mm Hg.
Ipertensjoni pulmonarja bi pressjoni sistolika fl- arterji tal- pulmun > 90 mm Hg.
Hypersensitivity has been reported.
Sensittività eċċessiva kienet irrappurtata.
Care should therefore be exercised.
Għalhekk wieħed għandu joqgħod attent.
A course of action should be planned in advance with necessary drugs and equipment available for immediate treatment, in case a serious reaction should occur.
Għandu jiġi maħsub pjan ta 'azzjoni minn qabel bil- mediċini u l- apparat neċessarju li jkunu disponibbli, fil- każ li jkun hemm reazzjoni serja.
The experience of OPTISON in severely ill patients is limited.
L- esperjenza ta 'OPTISON f' pazjenti morda serjament hija limitata.
There is limited clinical experience with OPTISON in patients with certain severe states of cardiac, pulmonary, renal and hepatic disease.
Hemm esperjenza klinika limitata b' OPTISON f' pazjenti li għandhom ċerti sitwazzjonijiet severi ta 'mard tal- qalb, tal- pulmun, tal- kliewi u tal- fwied.
Such clinical states include adult respiratory distress syndrome, the use of artificial respiration with positive end-expiratory pressure, severe heart failure (NYHA IV), endocarditis, acute myocardial infarction with on-going angina or unstable angina, hearts with prosthetic valves, acute states of systemic inflammation or sepsis, known states of hyperactive coagulation system and/ or recurrent thromboembolism, renal or hepatic end-stage disease.
Dawn is- sitwazzjonijiet kliniċi jinkludu s- sindromu ta 'distress respiratorju fl- adulti, l- użu ta' respirazzjoni artifiċjali bi pressjoni pożittiva wara li joħroġ in- nifs, insuffiċjenza severa tal- qalb (NYHA IV), endokardite, infart mijokardijaku akut b' anġina kontinwa jew angina instabbli, qlub b' valvoli prostetiċi, kondizzjonijiet akuti ta 'infjammazzjoni sistemika jew sepsis, kondizzjonijiet magħrufa tas- sistema tal- koagulazzjoni iperattiva u/ jew tromboëmboliżmu rikorrenti, mard ta ’ l- aħħar fażi fil- kliewi jew fil- fwied.
OPTISON should be used in these categories of patients only after careful consideration, and monitored closely during and after administration.
OPTISON għandu jintuża f' dawn il- kategoriji ta 'pazjenti biss wara ħafna ħsieb, u għandu jiġi monitorjat b' attenzjoni waqt u wara li jingħata.
Other routes of administration not specified in section 4.2 above (e. g. intracoronary injection) are not recommended.
Metodi oħra ta ’ kif jingħata, li mhux speċifikati f' taqsima 4. 2 hawn fuq (bħall- injezzjoni għal ġol- koronarja) mhux rakkomandati.
When medicinal products prepared from human blood or plasma are administered, infectious diseases due to the transmission of infective agents cannot be totally excluded.
Meta jingħataw prodotti mediċinali magħmulin mid- demm jew mil- plażma tal- bniedem, ma jistax jiġi eskluż għal kollox mard infettiv minħabba t- trażmissjoni ta 'sustanzi infettivi.
This applies also to pathogens of hitherto unknown origin.
Dan japplika wkoll għal patoġeni li sa issa ma konniex nafu minn fejn ġew.
To reduce the risk of transmission of infective agents, stringent controls are applied to the selection of blood donors and donations.
Biex jitnaqqas ir- riskju tat- trażmissjoni ta 'sustanzi infettivi, għandu jkun hemm kontrolli stretti fuq l- għażla tad- donaturi tad- demm u tad- donazzjonijiet.
In addition, virus removal and/ or inactivation procedures are included in the production process.
Ukoll, it- tneħħija ta 'virus u/ jew proċeduri ta' inattivazzjoni huma parti mill- proċess tal- produzzjoni.
The current procedures applied in the manufacture of medicinal products derived from human blood or plasma are effective against enveloped viruses such as HIV, hepatitis B and hepatitis C viruses.
Il - proċeduri li hemm bħalissa li jintużaw fil- manifattura ta 'prodotti mediċinali magħmulin mid- demm jew mil- plażma tal- bniedem huma effettivi kontra virus inkapsulat bħall- virus ta' l- HIV, epatite B u epatite C.
These procedures are of limited value against non-enveloped viruses such as hepatitis A virus.
Dawn il- proċeduri għandhom valur limitat kontra virus mhux inkapsulat bħall- virus ta 'l - epatite A.
OPTISON contrast echocardiography should be accompanied by ECG monitoring.
L- ekokardjografija b' kuntrast permezz ta ’ OPTISON għandha tiġi akkumpanjata b' immonitorjar bl - ECG.
In animal studies, the application of echo-contrast agents revealed biological side effects (e. g. endothelial cell injury, capillary rupture) by interaction with the ultrasound beam.
Fi studji fuq l- annimali, l- użu ta ’ sustanzi għall- eku- kuntrast urew effetti sekondarji bijoloġiċi (eżempju, ħsara fiċ- ċelluli endoteljali, tifqiegħ kapillarju) minħabba l- interazzjoni mar- raġġ ta ’ l - ultrasound.
Although these biological side effects have not been reported in humans, the use of a low mechanical index and end- diastolic triggering is recommended.
Għalkemm dawn l- effetti sekondarji bijoloġiċi ma ġewx irrapurtati fil- bnedmin, huwa rakkomandat l- użu ta ’ indiċi mekkaniku baxx u end- diastolic triggering.
Efficacy and safety in patients below 18 years has not been studied.
Ma ġewx studjati l- effikaċja u s- sigurta` f' pazjenti taħt it- 18- il sena.
Use during anaesthesia with halothane and oxygen has not been studied.
Ma ġiex studjat l- użu waqt anesteżija b' halothane u ossignu.
3 The safety of OPTISON for use during human pregnancy has not been established.
Ma ġietx stabbilita s- sigurta` ta 'l- użu ta ’ OPTISON waqt it- tqala fil- bniedem.
In pregnant rabbits exposed to daily doses of 2.5 ml/ kg (approximately 15 x the maximum recommended clinical dose) during organogenesis, maternal toxicity and embryo-foetal toxicity including a slight to extreme dilation of ventricles in the brain of developing rabbit embryos was observed.
Fi fniek tqal li ġew esposti għal dożi ta '2. 5 ml/ kg kuljum (bejn wieħed u ieħor 15- il darba iktar mid- doża massima klinika rakkomandata) waqt l- organoġenesi, ġew osservati tossiċita` fl- omm, tossicita` għall- embriju u l- fetu inkluż ftuħ minn ftit sa estrem tal- ventrikoli tal- moħħ ta' l- embrijI tal- fniek li qed jiżviluppaw.
The clinical relevance of this finding is unknown.
Ir - relevanza klinika ta 'din l- osservazzjoni mhix magħrufa.
Therefore OPTISON should not be used in pregnancy unless benefit outweighs risk and it is considered necessary by the physician.
Għalhekk, OPTISON m' għandux jintuża waqt 3 it- tqala ħlief meta l- benefiċċju jiżboq ir- riskju u jitqies neċessarju mit- tabib.
It is not known whether OPTISON is excreted in human milk.
Mhux magħruf jekk OPTISON joħroġx mal- ħalib ta 'l- omm.
Therefore, caution should be exercised when OPTISON is administered to breast-feeding women.
Għalhekk, trid tittieħed attenzjoni meta OPTISON jingħata lil nisa li qed ireddgħu.
Adverse reactions to OPTISON are rare and usually of a non-serious nature.
Reazzjonijiet avversi ta ’ OPTISON huma rari u s- soltu ma jkunux serji.
In general, the administration of human albumin has been associated with transient altered taste, nausea, flushing, rash, headache, vomiting, chills and fever.
B’ mod ġenerali, l- għoti ta 'l - albumina tal- bniedem ġiet assoċjata ma' bidla li tgħaddi fit- togħma, nawżja, fwawar, raxx, uġigħ ta 'ras, remettar, tkexkix ta ’ bard u deni.
Anaphylactic reactions have been associated with the administration of human albumin products.
Reazzjonijiet anafilattiċi li ġew assoċjati ma 'l- għoti ta' prodotti ta 'l- albumina tal- bniedem.
The reported adverse events following the use of OPTISON in Phase III human clinical studies have been mild to moderate with subsequent full recovery.
L- avvenimenti avversi, li ġew irrapurati wara l- użu ta 'OPTISON fi studji klinici ta' Fażi III fuq il- bniedem kienu minn ħfief sa moderati b' fejqan komplet wara.
In clinical trials with OPTISON, undesirable effects were reported as adverse events with the following frequencies given in the table below (Very common ≥ 1/ 10; Common (≥ 1/ 100 to < 1/ 10); Uncommon (≥ 1/ 1,000 to < 1/ 100); Rare (≥ 1/ 10,000 to < 1/ 1,000); Very rare < 1/ 10,000, not known (cannot be estimated from the available data)).
Fi provi kliniċi b' OPTISON, l- effetti mhux mixtieqa ġew irrapurtati bħala avvenimenti avversi bil - frekwenzi li ġejjin, mogħtija fit- Tabella t’ hawn taħt (Komuni ħafna ≥1/ 10; Komuni (≥1/ 100 sa < 1/ 10); Mhux komuni (≥1/ 1, 000 sa < 1/ 100); Rari (≥1/ 10, 000 sa < 1/ 1, 000); Rari ħafna < 1/ 10, 000, mhux magħrufa (ma jistgħux ikunu stmati mid- dejta disponibbli)).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla f’ ordni li tibda b’ dak l- iżjed serju u tkompli sa dak l- inqas serju.
Undesirable Effects
Effetti mhux mixtieqa
Eosinophilia
Esinofilja
Dysgeusia (altered taste), headache
Disgewsja (togħma differenti), uġigħ ta 'ras
Tinnitus, dizziness, paraesthesia
Tinnitus, parestesija, sturdament.
Eye disorders Respiratory, thoracic and mediastinal disorders
Disturbi respiratorji, toraċiċi medjastinali
Visual disturbances Dyspnoea
u Dispneja
Not known* Uncommon
Mhux komuni
Vascular disorders General disorders and administration site conditions
Disturbi vaskulari Disturbi ġenerali
Flushing Warm sensation
Fwawar u Sensazzjoni ta ’ sħana
Chest pain
mnejn
Allergic type symptoms (e. g. anaphylactoid reaction or -shock, face oedema, urticaria)
Sintomi tat- tip allerġiku (eż. reazzjoni Mhux anafilaktojde jew - xokk, edema tal- wiċċ, magħrufa * ħakk)
* Reactions for which no frequency rate can be provided due to lack of clinical trial data, have been classified as “ Not known”.
* Reazzjonijiet li għalihom ma tista ’ tiġi pprovduta l- ebda rata ta ’ frekwenza minħabba nuqqas ta ’ dejta minn provi kliniċi kienu kklassifikati bħala “ Mhux magħrufa ”.
In the Phase I trial, healthy volunteers have received up to 44.0 ml of OPTISON and experienced no significant adverse events.
Fil- prova ta 'Fażi I, voluntiera f' saħħithom rċevew sa 44. 0 ml ta' OPTISON u ma kellhomx avvenimenti avversi sinifikanti.
5.1 Pharmacodynamic properties
4 5. 1 Tagħrif farmakodinamiku
Ultrasound contrast medium, ATC Code:
Medjum għall- kuntrast fl- ultrasawnd, Kodiċi ATC:
When used in conjunction with diagnostic ultrasound, OPTISON provides opacification of cardiac chambers, improvement in delineation of endocardial borders, enhancement of the Doppler signal, and visualisation of wall motion and blood flow within the heart.
Meta jintuża flimkien ma 'l- ultrasawnd għal skop dijanjostiku, OPTISON iċajpar il- kompartiment tal - qalb, juri b' mod iktar ċar il- borduri endokardjali, iqawwi l- effett ta' Doppler, u jtejjeb il - viżwalizzazzjoni tal- moviment tal- ħajt u tad- demm ġol- qalb.
The ultrasound echoes from blood and biological soft tissues such as fat and muscles are generated at interfaces due to small differences in the ultrasonic properties of the tissues.
L- ekujiet ta 'l- ultrasawnd mid- demm u mit- tessuti bijoloġiċi rotob bħax- xaħam u l- muskoli jiġu ġġenerati fejn jiltaqgħu it- tessuti minħabba differenzi żgħar fil- karatteristiċi ultrasoniċi tat- tessuti.
The ultrasonic properties of microspheres containing perflutren are very different from that of soft tissue and will generate strong echoes.
Il - karatteristiċi ultrasoniċi ta 'mikrosferi li fihom perflutren huma differenti ħafna minn dawk ta' tessuti rotob u jiġġeneraw ekujiet qawwija.
OPTISON consists of perflutren -containing microspheres.
OPTISON jikkonsisti f' mikrosferi li fihom perflutren.
The microspheres have a mean diameter of 2.5 - 4.5 microns and concentrations of 5-8 x 108 microspheres/ ml.
Mikrosferi ta 'dan il- limitu ta' daqs
Microspheres in this size range contribute to the contrast effect by generating strongly enhanced echoes.
jikkontribwixxu għall- effett tal- kuntrast billi jiġġeneraw ekujiet ħafna iktar qawwija.
As OPTISON consists of microspheres that are stable and small enough for transpulmonary passage, it will also give enhanced echo signals in the left heart cavities.
Billi OPTISON jikkonsisti f mikrosferi li huma stabbli u żgħar biżżejjed biex jgħaddu minn ġol - pulmun, jagħti ekujiet iktar qawwija fil- kavitajiet tax- xellug tal- qalb.
As a consequence of the complex relationship between the concentration of the microspheres and the ultrasound signal, data processing within the ultrasound equipment and the fact that each individual responds differently due to variability in cardiac and pulmonary function, a strict dose/ response relationship cannot be defined.
Bħala konsegwenza tar- relazzjoni kumplessa bejn il- konċentrazzjoni tal- mikrosferi u s- sinjal ta 'l - ultrasawnd, l- ipproċessar tat- tagħrif fil- makkinarju ta' l- ultrasawnd u l- fatt li kull individwu jirrispondi b' mod differenti minħabba l- funzjoni differenti tal- qalb u tal- pulmun, ma tistax tiġi definita relazzjoni stretta bejn d- doża u r- rispons.
The dose of OPTISON will therefore have to be adjusted individually, although clinical studies have shown that an initial dose of 0.5 - 3.0 ml per patient can be recommended for left heart opacification.
Għalhekk id- doża ta 'OPTISON trid tinbidel b' mod individwali, għalkemm studji kliniċi wrew li doża inizjali ta' 0. 5 - 3. 0 ml għal kull pazjent tista 'tiġi rakkomandata biex tiċċajpar in- naħa xellugija tal- qalb.
Higher doses produce greater contrast effect of longer duration.
Dożi ogħla jipproduċu effetti ikbar ta 'kuntrast li jdumu iktar.
Duration of useful contrast effect at the recommended dose is adequate to perform a complete echocardiographic examination including Doppler assessment.
It- tul tal- ħin ta 'effett utli ta' kuntrast bid- doża rakkomandata huwa adegwat biex isir eżami ekokardjografiku sħiħ li jinkludi assessjar bid- Doppler.
Use the smallest dose for adequate opacification of cavities since larger doses produce image blocking effects with the possibility of obscuring important information.
Uża l- iżgħar doża biex jiċċajpru l- kavitajiet, billi dożi ikbar jipproduċu effetti li jimblukkaw l - immaġini bil- possibilita` li tinħeba informazzjoni importanti.
Following intravenous injection of 0.21 to 0.33 ml/ kg of OPTISON to healthy volunteers, the perflutren component of OPTISON was rapidly and nearly completely eliminated in less than 10 minutes with a dominating pulmonary elimination half life of 1.3±0.7 minutes.
Wara injezzjoni fil- vina ta '0. 21 sa 0. 33 ml/ kg ta' OPTISON lil voluntiera f' saħħithom, is- sustanza, perflutren ta 'OPTISON tneħħiet malajr u kważi għal kollox f' inqas minn 10 minuti; b’ half- life ta ’ eliminazzjoni mill- pulmun ta ’ 1. 3±0. 7 minuti.
The perflutren levels detected in blood following this dosage were too low and transient to accurately determine pharmacokinetic parameters.
Il- livelli ta 'perflutren li ġew osservati fid- demm wara dan id- dożaġġ kienu baxxi wisq u jgħaddu malajr wisq biex jiġu determinati b' mod preċiż il- parametri farmakokinetiċi.
The disposition and elimination of the albumin microspheres have not been studied in humans.
Id- dispożizzjoni u l- eliminazzjoni tal- mikrosferi ta 'l- albumina ma ġewx studjati fil- bnedmin.
Information obtained from a preclinical study in rats with 125I-labelled albumin microspheres indicated that microspheres were rapidly cleared from the circulation, and radio-labelled microspheres, albumin
L - informazzjoni li nkisbet fi studju prekliniku fil- firien b' mikrosferi ta 'l- albumina ttikkettati b ’ 125I, indikat li l- mikrosferi malajr tneħħew miċ- ċirkolazzjoni, u l- mikrosferi radju- tikkettati, il- qxur ta' l - albumina u 125I ttieħdu l- iktar mill- fwied.
The primary route of elimination of radioactivity was the urine.
Il- metodu primarju ta ’ l- eliminazzjoni tar- radjuattivita` kien permezz ta 'l- urina.
10% of the total dose 40 minutes after dose administration (cf.
Il- pulmuni wkoll żammew livelli għolja ta 'radjuattivita` għal żmien mhux ħażin, bejn wieħed u ieħor 10% tad- doża totali 40 minuta wara li ngħatat id- doża (cf.
35% in liver).
35% fil- fwied).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity and genotoxicity.
Tagħrif ta ’ qabel l- użu kliniku magħmul fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi akuti u ripetuti u effett tossiku fuq il- ġeni, ma juri l- ebda periklu speċjali għall - bnedmin.
In the rabbit embryotoxicity study, a significant increase in the number of fetuses with dilated ventricles in the brain was observed (see section 4.6).
Fi studju dwar it- tossiċita` fl- embriju fil- fniek, ġie osservat tkattir sinifikanti tan- numri ta 'feti li kellhom twessiegħ fil- ventrikoli tal- moħħ (ara taqsima 4. 6).
No such finding was observed in the rat embryotoxicity study.
Ma saret l- ebda osservazzjoni ta 'dan it- tip fl- istudju dwar it- tossiċita` fl- embriju fil- firien.
Human albumin Sodium chloride N-acetyltryptophan Caprylic acid Sodium hydroxide (pH adjustment) Water for injections
Human albumin Sodium chloride N- acetyltryptophan Caprylic acid Sodium hydroxide (aġġustament tal- pH) Ilma għall- injezzjonijiet
Finished product after rubber stopper perforation:
Kunjett mhux miftuħ fil- pakkett ta 'barra: sentejn
Store upright in a refrigerator (2oC - 8ºC).
Aħżen f’ pożizzjoni vertikali fi friġġ (2oC - 8ºC).
Storage at room temperature (up to 25ºC) for 1 day is acceptable.
Il- ħażna f' temperatura tal- kamra (sa 25ºC) għal ġurnata hu aċċettabbli.
Do not freeze.
Tiffirżax.
3 ml type I glass vial, closed with bromobutyl rubber stopper, and sealed with aluminium cap with coloured plastic flip-off top.
Kunjett tal- ħġieġ ta ’ tip I ta ’ 3 ml magħluq b’ tapp tal- gomma tal- bromobutyl, u ssiġillat b' għatu ta 'l - aluminju u b' għatu tal- plastik ikkulurit li jinfetaħ b’ daqqa ta ’ saba ’.
1 vial of 3 ml or 5 vials of 3 ml.
OPTISON hu fornut bħala: kunjett wieħed ta '3 ml jew 5 kunjetti ta' 3 ml.
Not all pack sizes may be marketed.
Mhux id- daqsijiet kollha tal- pakketti jistgħu ikunu fis- suq.
Like all parenteral products, the vials of OPTISON should be inspected visually for integrity of the container.
Bħal kull prodott li jiġi njettat, il- kunjetti ta 'OPTISON għandhom jiġu spezzjonati billi wieħed iħares sewwa lejhom għall- integrita` tal- kontenitur.
6 Vials are intended for single use only.
Il- kunjetti huma intenzjonati għal użu ta ’ darba.
Once the rubber stopper has been penetrated, the contents should be used within 30 minutes and any unused product discarded.
Ladarba t- tapp tal- gomma jittaqqab, il- prodott għandu jintuża fi żmien 30 minuta u kull fdal tal- prodott li ma jiġix użat għandu jintrema.
OPTISON in the non-resuspended form has a white layer of microspheres on top of the liquid phase that requires resuspension before use.
OPTISON, meta mhux mħallat, mill- ġdid għandu saff abjad ta 'mikrosferi fil- wiċċ tal- fażi likwida li għandha bżonn terġa' titħallat qabel tintuża.
Homogenous white suspension after resuspension.
Suspensjoni bajda omoġenja wara s- suspensjoni ssir mill - ġdid.
The following instructions should be followed:
Għandhom jiġu segwiti dawn l- istruzzjonijiet:
- Cold solutions taken directly from the refrigerator should not be injected.
- Soluzzjonijiet kesħin li għadhom ħerġin mill- friġġ m' għandhomx jiġi injettati.
- Allow the vial to reach room temperature and inspect the liquid phase for particulate matter or
- Ħalli l- kunjett jilħaq it- temperatura tal- kamra u spezzjona l- fażi likwida biex tara jekk hemmx xi
precipitates before resuspension.
frak jew biċċiet mhux imdewba qabel it- taħlit mill- ġdid.
Attach a
- Daħħal kannula tal- plastik 20 G f' vina kbira antekubitali, preferibbilment fid- driegħ tal- lemin.
three-way stopcock to the cannula.
6 Waħħal vit ta 'bi tlieta mal- kannula.
- The OPTISON vial must be inverted and gently rotated for approximately three minutes to
- Il- kunjett ta 'OPTISON irid jinqaleb rasu ‘ l isfel u jiddawwar bil- mod għal bejn wieħed u ieħor
completely resuspend the microspheres.
tliet minuti biex il- mikrosferi jerġgħu jitħalltu.
- Complete resuspension is indicated by a uniformly opaque white suspension and absence of any
- It- taħlit mill- ġdid ikun komplut meta s- suspensjoni tkun kollha bajda mċajpra bl- istess mod u
material on stopper and vial surfaces.
ma jkunx hemm traċċi mat- tapp u mal- ġnub tal- kunjett.
- OPTISON should be withdrawn with care into a syringe within 1 minute after resuspension.
- OPTISON għandu jinġibed bil- mod b' siringa fi żmien minuta mit- taħlit mill- ġdid.
- Any pressure instability within the vial should be avoided since it may cause disruption of
- Għandha tiġi evitata kull instabilita` tal- pressa ta 'ġol- kunjett billi dan jista' jiddisturba l -
microspheres and loss of contrast effect.
mikrosferi u jnaqqas mill- effett tal- kuntrast.
Thus, vent the vial with a sterile spike or with a sterile 18 G needle before withdrawing the suspension into the injection syringe.
Għalhekk, taqqab il- kunjett b' niggieża sterili jew b' labra sterili 18 G qabel tiġbed is- suspensjoni fis- siringa għall- injezzjoni.
Do not inject air into the vial as this will damage the product.
Tinjettax arja fil - kunjett għax dan jikkawża ħsara lill- prodott.
- Use the suspension within 30 minutes after withdrawal.
- Uża s- suspensjoni fi żmien 30 minuta minn meta tinġibed.
- OPTISON will segregate in an undisturbed syringe and must be resuspended before use.
- OPTISON jerġa 'jinfired f' siringa li titħalla toqgħod u jrid jerġa' jitħallat qabel jintuża.
- Resuspend the microspheres in the syringe immediately before injection by holding the syringe
- Erġa 'ħallat il- mikrosferi fis- siringa eżatt qabel l- injezzjoni billi żżomm is- siringa minduda bejn
horizontally between the palms of the hands and rolling it quickly back and forth for no less than 10 seconds.
l- uċuh ta 'l- idejn u tirrumblaha malajr lura u' l quddiem għal mhux inqas minn 10 sekondi.
- Inject the suspension through the plastic cannula, no smaller than 20 G at a maximum injection
- Injetta s- suspensjoni permezz tal- kannula tal- plastik, li ma tkunx iżgħar minn 20 G b' rata
rate of 1.0 ml/ s.
massima ta 'injezzjoni ta' 1. 0 ml/ s.
Warning:
Attenzjoni:
Never use any other type of route but the open flow connection.
Qatt tuża mod ieħor jekk mhux il- konnessjoni b' nixxiegħa ħielsa (open flow connection).