natgillin/translations-raw huggingface dataset:
• you had any reactions to previous injections of a contrast agent, including a previous history of reaction to iodine-based contrast agents
• ste v preteklosti imeli reakcijo pri injiciranju kontrastnih sredstev, vključno z reakcijami na kontrastna sredstva na osnovi joda;
• Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the following measures: Description
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okvirju izvesti naslednje ukrepe: Opis
headache, strange taste in the mouth, feeling hot
glavobol, nenavaden občutek v ustih, občutek vročine
Optimark must not be administered with an autoinjector.
Zdravilo Optimark se ne sme dajati z avtoinjektorjem.
Cases of nephrogenic systemic fibrosis (NSF) have been reported with Optimark (see section 4.4).
Z uporabo zdravila Optimark so poročali o primerih nefrogene sistemske fibroze (NSF) (glejte poglavje 4.4).
Optimark has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Optimark nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription.
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom.
• if you are a patient who is about to have or has had a liver transplant as use of Optimark in patients with these conditions has been associated with a disease called nephrogenic systemic fibrosis (NSF).
• boste ali ste imeli presaditev jeter, saj je njegova uporaba pri bolnikih s temi boleznimi povezana z boleznijo, imenovano nefrogena sistemska fibroza (NSF).
Caution should be exercised in elderly patients (see section 4.4).
Pri starejših bolnikih je potrebna previdnost (glejte poglavje 4.4).
Electrocardiogram QT prolonged
Podaljšan interval QT pri elektrokardiogramu
Talk to your doctor before Optimark is used, if:
Pred začetkom uporabe zdravila Optimarku se pogovorite z zdravnikom, če:
Gadoversetamide plasma levels increase linearly with decreasing renal function; in patients with severe renal impairment (CrCl<30 ml/min) this even leads to a six-fold decreased gadoversetamide clearance and a corresponding six-fold increased extent of exposure AUC and t½.
Ravni gadoversetamida v plazmi se linearno večajo z zmanjšanjem ledvične funkcije; pri bolnikih s hudo ledvično okvaro (CrCl < 30 ml/min) to lahko povzroči tudi šestkratno zmanjšanje očistka gadoversetamida in ustrezno šestkratno povečanje izpostavljenosti AUC in t½.
If electronic patient records are used, the name of the product, the batch number and the dose should be entered into the patient record.
Če se uporablja elektronska kartoteka bolnika, je treba v kartoteko bolnika vnesti ime zdravila, številko serije in odmerek.
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.
Pred injiciranjem kontrastnega sredstva je treba bolnike vprašati, ali imajo kakršnekoli alergije (npr. alergije na morsko hrano ali zdravila, seneni nahod, urtikarijo) ali so preobčutljivi za kontrastna sredstva ali imajo bronhialno astmo.
Therefore, caution should be exercised when contrast enhanced scan interpretation is made in the absence of a companion unenhanced MRI.
Zato je treba biti previden pri interpretaciji slike z okrepljenim kontrastom brez spremljajoče slike MRI z neokrepljenim kontrastom.
Since gadoversetamide is only administered as a single dose this will lead to a longer and higher exposure for a limited duration.
Gadoversetamid se uporablja v obliki enkratnega odmerka, zato je trajanje te podaljšane in večje izpostavljenosti omejeno.
Optimark is contraindicated in these patients (see section Contraindications).
Zdravilo Optimark je pri teh bolnikih kontraindicirano (glejte poglavje Kontraindikacije).
Patients who have had or are undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group.
Pri bolnikih, pri katerih so opravili ali opravljajo presaditev jeter je tveganje še zlasti veliko, saj je v tej skupini incidenca akutne ledvične odpovedi visoka.
Do not use the solution if it is discoloured or particulate matter is present.
Raztopine ne uporabljajte, če je obarvana ali če so v njej delci.
Gadolinium containing MRI contrast agents (gadolinium-based chelates) are designed to act indirectly on the local magnetic environment by altering proton T1 (spin-lattice) and T2 (spin-spin) relaxation times and at the usual concentration of 100 micromol/kg, the T1 shortening predominates, and the T2 shortening is not significant using T1-weighted sequences.
Kontrastna sredstva za slikanje MRI, ki vsebujejo gadolinij (kelati na osnovi gadolinija), delujejo neposredno na lokalno magnetno okolje, tako da spremenijo protonski relaksacijski čas T1 (spinsko mrežni) in T2 (spinsko spinski) ter pri običajni koncentraciji 100 mikromolov/kg prevladuje krajšanje časa T1, krajšanje časa T2 pa ni tako pomembno pri poudarjenih zaporedjih T1.
Clinical studies on fertility have not been performed.
Kliničnih študij plodnosti niso izvajali.
Optimark should not be used during pregnancy unless strictly necessary.
Uporaba zdravila Optimark med nosečnostjo ni dovoljena, razen če je nujno potrebna.
Therefore, within this dose range, the kinetics of gadoversetamide appear to be linear.
Zato je videti, da je v tem intervalu odmerkov kinetika gadoversetamida linearna.
However, these were not evident from clinical trials with Optimark.
Vendar pa teh reakcij v kliničnih preskušanjih z zdravilom Optimark ni bilo.
The most common side effects were a strange taste in the mouth, feeling hot, headache and dizziness.
Najpogostejši neželeni učinki so bili nenavaden okus v ustih, občutek vročine, glavobol in omotica.
The agent should be administered as a bolus peripheral intravenous injection.
Kontrastno sredstvo se daje v obliki bolusne periferne intravenske injekcije.
To ensure complete injection of the contrast medium, the injection should be followed by a 5 ml flush of sodium chloride 9 mg/ml (0.9 %) solution for injection.
Da se zagotovi injiciranje celotne količine kontrastnega sredstva, mora injekciji slediti spiranje s 5 ml 0,9-odstotne raztopine natrijevega klorida (9 mg/ml) za injiciranje.
Gadoversetamide is dialysable.
Gadoversetamid se lahko dializira.
Hypersensitivity to gadoversetamide or to other gadolinium containing products, or to any of the excipients listed in section 6.1.
Preobčutljivost na gadoversetamid, druga zdravila, ki vsebujejo gadolinij, ali katero koli pomožno snov, navedeno v poglavju 6.1 .
When Optimark was used in children aged 2 or older they had similar side effects as in adults.
Pri uporabi zdravila Optimark pri otrocih, starih 2 leti ali več, so bili neželeni učinki podobni kot pri odraslih.
In adults, a second dose may be given within 30 minutes of the first injection.
V 30 minutah po prvem odmerku lahko odraslim dajo drugega.
For electronic records: enter product name, batch no. and dose.
Za elektronske kartoteke: vnesite ime zdravila, št. serije in odmerek.
Gadoversetamide is a chelate containing gadolinium - which has paramagnetic properties and is responsible for the contrast enhancement effect in MRI - and the ligand versetamide.
Gadoversetamid je gadolinij, ki vsebuje kelat, ki ima paramagnetne lastnosti in povzroča krepitev kontrasta pri slikanju MRI, in ligand versetamid.
This volume of distribution (approximately 10-15 l for a body weight of 70 kg) is consistent with a medicinal product which distributes into the extracellular fluid.
Ta volumen porazdelitve (približno 10-15 l pri telesni masi 70 kg) je skladen z zdravili,
Optimark should only be administered by physicians experienced in clinical MRI practice.
Zdravilo Optimark smejo uporabljati le zdravniki, izkušeni v klinični praksi magnetnoresonančnega slikanja.
The enhancement of brain tumours using a gadolinium (or iodine) containing contrast agent depends on the disruption of the blood brain barrier (BBB).
Krepitev vidnosti možganskih tumorjev s kontrastnimi sredstvi, ki vsebujejo gadolinij (ali jod), je odvisna od okvar krvno-možganske pregrade.
The high accountability for the dose as intact complex in urine suggests that no significant metabolism of gadoversetamide occurs in humans.
Velik del odmerka se izloči kot nedotaknjen kompleks v urinu, kar kaže na to, da pri človeku ne prihaja do pomembne presnove gadoversetamida.
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute toxicity, reproductive toxicity, local tolerance, antigenicity, and genotoxicity.
Neklinični podatki na osnovi običajnih študij farmakološke varnosti, akutne toksičnosti, sposobnosti razmnoževanja, lokalne tolerance, antigenosti in genotoksičnosti ne kažejo posebnega tveganja za ljudi.
The elimination half life at the 100 micromol/kg dose ranges from 1.49 ± 0.15 h in healthy volunteers to 2.11 ± 0.62 h in non-renally impaired patients (including normal subjects and patients with CNS or liver pathology).
Razpolovni čas izločanja pri odmerku 100 mikromolov/kg je od 1,49 ± 0,15 h pri zdravih prostovoljcih do 2,11 ± 0,62 h pri bolnikih brez ledvične okvare (vključno z normalnimi osebami in bolniki z boleznijo osrednjega živčevja ali jeter).
Discard syringe and unused portion of the solution after use.
Brizgo in neuporabljeno raztopino po uporabi zavrzite.
6.6 Special precautions for disposal and other handling Optimark is intended for single use only; any unused portions should be discarded.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravilo Optimark je namenjeno enkratni uporabi; neuporabljeno zdravilo zavrzite.
If non-disposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.
Pri uporabi opreme za večkratno uporabo morate biti izjemno previdni, da preprečite kontaminacijo z ostanki čistil.
• in patients in the perioperative liver transplantation period and
• pri bolnikih v perioperativen obdobju presaditve jeter in
Do not use this medicine after the expiry date which is stated on the carton and on the syringe label after EXP.
Tega zdravila ne smete uporabljati po izteku roka uporabnosti, ki je naveden na nalepki škatle in injekcijske brizge poleg oznaki EXP.
Before you receive Optimark, you will need to have a blood test to check how well your kidneys are working.
Preden pri vas uporabijo zdravilo Optimark, morate opraviti krvne preiskave, s katerimi ugotavljajo delovanje vaših ledvic.
Optimark is for diagnostic use, only.
Zdravilo Optimark je samo za diagnostične namene.
Psychiatric Disorders
Psihiatrične motnje
10 ml vials and 15 ml vials contain less than 1 mmol sodium; i.e. they are essentially ‘sodium free‘.
10 ml viale in 15 ml viale vsebujejo manj kot 1 mmol natrija, kar v bistvu pomeni "brez natrija".
Blood creatinine increased, Haematuria
Zvišanje kreatinina v krvi, hematurija
Precautions to be taken before handling or administering the medicinal product The container and the solution should be inspected prior to use.
Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila Vsebnik in raztopino je treba pred uporabo pregledati.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Formalnih študij medsebojnega delovanja niso izvedli.
Therefore, Optimark must not be used in patients who have had or are undergoing liver transplantation and in neonates (see section 4.3).
Zato se zdravilo Optimark pri bolnikih, pri katerih so opravili ali opravljajo presaditev jeter in pri novorojenčkih ne sme uporabljati (glejte poglavje 4.3).
Therefore, Optimark must not be used in patients who have had or are undergoing liver transplantation and in neonates.
Zato uporaba zdravila Optimark ni dovoljena pri bolnikih, pri katerih so opravili ali opravljajo presaditev jeter in pri novorojencih.
The required dose should be administered by hand to children of 2 to 11 years to avoid overdosage by mistake.
Otrokom, starim 2 do 11 let, je treba potrebni odmerek injicirati ročno, da se tako prepreči nenamerno preveliko odmerjanje.
Prior to the launch, the MAA shall provide to all potential prescribers a copy of the SPC with a cover letter highlighting the safety information included in Sections 4.3 and 4.4.
• Dodatni ukrepi za zmanjševanje tveganj Pred začetkom trženja zdravila mora imetnik dovoljenja za promet z zdravilom vsem morebitnim predpisovalcem predložiti kopijo povzetka glavnih značilnosti zdravila in spremno pismo, v katerem so poudarjene varnostne informacije iz poglavij 4.3 in 4.4.
Children and adolescents Optimark is not recommended in children who are below the age of two years.
Otroci in mladostniki Uporaba zdravila Optimark pri otrocih, mlajših od dveh let, se ne priporoča.
It is unknown whether gadoversetamide is excreted in human milk.
Ni znano, ali se gadoversetamide izloča v materino mleko.
The agent should be administered as a bolus peripheral intravenous injection at a dose of 0.2 ml/kg (100 micromol/kg) body weight.
Sredstvo je treba uporabiti v obliki bolusne periferne intravenske injekcije z odmerkom 0,2 ml/kg (100 mikromolov/kg) telesne mase.
In patients with compromised renal function, clearance of gadoversetamide will be slowed and the interference with calcium determination by OCP prolonged.
Pri bolnikih z okvarjenim delovanjem ledvic je očistek gadoversetamida upočasnjen, motnja meritev kalcija z metodo OCP pa dolgotrajnejša.
Nasal congestion, Throat irritation
Nosna kongestija, draženje grla
In patients with baseline renal impairment, acute kidney injury requiring dialysis has occurred with the use of Optimark.
Pri bolnikih z izhodiščno okvaro ledvic je pri uporabi zdravila Optimark prišlo do akutne poškodbe ledvic, ki je zahtevala dializo.
The elimination half life in the 2 to 11 and 12 to 18 year age groups (1.4 ± 0.3 and 1.6± 0.3 h-1, respectively) is shorter than that observed in the two adult populations (1.9 ± 0.5 and 2.5± 0.5 h-1 in the 19 to 64 and ≥ 65 year of age groups, respectively).
Razpolovni čas izločanja v starostnih skupinah od 2 do 11 let in od 12 do 18 let (1,4 ± 0,3 h-1 pri skupini od 2 do 11 let in 1,6 ± 0,3 h-1 pri skupini od 12 do 18 let) je krajši kakor pri dveh skupinah odraslih (1,9 ± 0,5 h 1 pri skupini od 19 do 64 let in 2,5 ± 0,5 h-1 pri skupini ≥ 65 let).
• The active substance is gadoversetamide.
• Zdravilna učinkovina je gadoversetamid.
• Hypersensitivity to gadoversetamide or to other gadolinium containing products or to any of the excipients.
• Preobčutljivost za gadoversetamid, za druga zdravila, ki vsebujejo gadolinij, ali katero koli pomožno snov.
Because of the lack of information on repeated administration, Optimark injections should not be repeated unless the interval between injections is at least 7 days.
Zaradi pomanjkanja podatkov o ponavljajočem odmerjanju je ponovno injiciranje zdravila Optimark dovoljeno šele po poteku časovnega presledka 7 dni.
• you suffer from allergies (e.g. medicinal products, seafood, hay fever, hives) or asthma
• imate alergijo (npr. na zdravila, morsko hrano, seneni nahod ali koprivnico) ali astmo;
Not all package sizes may be marketed.
Na trgu morda ni vseh navedenih pakiranj.
Syringe tip cap and piston are made of bromobutyl rubber.
Zaporka konice in bat brizge sta izdelana iz bromobutilne gume.
Neonates and infants
Novorojenčki in dojenčki
In patients with moderate kidney problems, more than one dose of Optimark should not be used during a scan.
Pri bolnikih z zmernimi težavami z ledvicami med slikanjem ni dovoljeno uporabiti več kot enega odmerka zdravila Optimark.
Serum iron and zinc
Železo in cink v serumu
Optimark should not be used in children below the age of two years.
Zdravilo Optimark se ne sme uporabljati pri otrocih, mlajših od dveh let.
Optimark contains sodium
Zdravilo Optimark vsebuje natrij
swelling around the eyes, abnormal ECG heart tracing, fainting, vomiting
otekanje okrog oči, nenormalni izvidi EKG, omedlevica, bruhanje
Mean volume of distribution at the 100 micromol/kg dose in non-renally impaired patients (including both normal subjects and patients with CNS or liver pathology) was 158.7 ± 29.0 to 214.3 (range 116.4 to 295.0) ml/kg.
Povprečni volumen porazdelitve pri odmerku 100 mikromolov/kg pri bolnikih brez ledvične okvare (vključno z normalnimi osebami in bolniki z boleznijo osrednjega živčevja ali jeter) je od 158,7 ± 29,0 do 214,3 (interval od 116,4 do
Inspect the syringe for signs of leakage.
Preverite, ali obstajajo kakršnikoli znaki uhajanja raztopine iz brizge.
The risk of hypersensitivity reactions is increased in the following cases: - patients with allergic predisposition - patients with bronchial asthma; in these patients it is especially the risk of bronchospasm which is increased - patients with a history of reactions to contrast agents, including a previous history of reaction to iodine-based contrast agents
- bolnikih z bronhialno astmo; pri teh bolnikih je zlasti povečano tveganje za pojav bronhospazmov; - bolnikih z reakcijami na kontrastna sredstva v anamnezi, vključno z reakcijami na kontrastna sredstva na osnovi joda.
Optimark is contraindicated in neonates up to 4 weeks of age.
Zdravilo Optimark je kontraindicirano pri novorojencih do starosti 4 tednov.
The majority of adverse reactions observed after the use of gadoversetamide were found to be adverse reactions of the nervous system, followed by general adverse reactions, gastrointestinal disorders/skin and subcutaneous tissue disorders.
Ugotovili so, da je bila večina neželenih učinkov, ki so jih opazili po uporabi gadoversetamida, učinkov na živčevje, sledile so jim splošne neželene reakcije, bolezni prebavil in bolezni kože in podkožja.
Chest discomfort, Chest pain, Feeling cold (including peripheral coldness), Administration site reactions
Občutek neugodja v prsnem košu, bolečina v prsnem košu, občutek mraza (vključno s hladnimi okončinami, reakcije na mestu aplikacije
Optimark has been shown to cause interference in the measurement of serum calcium using the orthocresolphthalein complexone (OCP) colorimetric method.
Pokazalo se je, da zdravilo Optimark povzroča motnje pri merjenju kalcija v serumu s kolorimetrično metodo s kompleksonom orto-krezolftaleina (OCP).
The most common adverse reactions were dysgeusia, feeling hot, headache and dizziness.
Najpogostejši neželeni učinki so bili disgevzija, občutek vročine, glavobol in omotica.
Optimark is contraindicated in neonates up to 4 weeks of age (see section 4.3).
Zdravilo Optimark je kontraindicirano pri novorojencih do starosti 4 tednov (glejte poglavje 4.3).
Gadoversetamide is used as a ‘contrast agent' in magnetic resonance imaging.
Gadoversetamid se uporablja kot kontrastno sredstvo pri magnetnoresonančnem slikanju.
Allergoid and other idiosyncratic reactions also may occur with gadoversetamide, which could become manifest in form of cardiovascular, respiratory and skin reactions (see section 4.8).
Te reakcije se lahko pokažejo v obliki kardiovaskularnih, respiratornih ali kožnih reakcij (glejte poglavje 4.8).
• 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.
• Uporaba zdravila Optimark ni priporočena pri otrocih, mlajših od dveh let, saj varnosti, učinkovitosti in vpliva na delovanje nerazvitih ledvic pri tej starostni skupini niso raziskovali.
• neonates up to 4 weeks of age.
• pri novorojenčkih, starih do 4 tedne.
Special precautions for disposal and other handling Optimark is intended for single use only; any unused portions should be discarded.
Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravilo Optimark je namenjeno enkratni uporabi; neuporabljeno zdravilo zavrzite.
Palpitations, AV block first Tachycardia, Arrhythmia
Palpitacije, AV-blok prve stopnje, ekstrasistole, tahikardija, aritmija
Optimark must not be administered with an autoinjector to children of 2 to 11 years (see section 4.4).
Otrokom, starih od 2 do 11 let, se zdravila Optimark ne sme dati z avtoinjektorjem (glejte poglavje 4.4).
To enable immediate action in emergencies, the necessary medicinal products (e.g. epinephrine/ adrenaline, theophylline, antihistamines, corticosteroids and atropines), endotracheal tube and ventilator must be immediately available.
Za takojšnje ukrepanje v nujnih primerih morajo biti na voljo nujna zdravila (npr. epinefrin/adrenalin, teofilin, antihistaminiki, kortikosteroidi in atropini), endotrahealni tubus in respirator.
Blood calcium abnormal
Nenormalne vrednosti kalcija v krvi
Especially in patients with serious heart diseases (e.g. severe heart failure, coronary artery disease) cardiovascular reactions may deteriorate.
Kardiovaskularne reakcije se lahko poslabšajo zlasti pri bolnikih z resnimi srčnimi boleznimi (npr. hudo srčno popuščanje, koronarna srčna bolezen).
The MAH shall submit annual cumulative reviews on nephrogenic systemic fibrosis (NSF) cases.
Imetnik dovoljenja za promet z zdravilom bo predložil letne kumulativne preglede primerov nefrogene sistemske fibroze (NFS).
June 2018
Končno poročilo o študiji: junija 2018
allergic/hypersensitivity reaction, dizziness, tingling sensation, numbness, reduced sense of smell, skin red and warm, nasal congestion, sore throat, nausea, diarrhoea, itching, rash, chest discomfort, chest pain, feeling cold including cold feeling in extremities, administration site reactions, changes in blood calcium levels
alergijske/preobčutljivostne reakcije, omotica, mravljinčenje, otrplost, oslabljen voh, rdeča in topla koža, zamašen nos, boleče grlo, slabost, driska, srbenje, izpuščaj, neprijeten občutek v prsnem košu, bolečine v prsnem košu, občutek mraza, vključno z občutkom mraza v okončinah, reakcije na mestu injiciranja, spremembe ravni kalcija v krvi
The vials are fitted with bromobutyl rubber closures, aluminium cap seals, and plastic flip caps.
Na vialah so pokrovi iz bromobutilne gume, aluminijasta tesnila in plastični pokrovčki.
What Optimark looks like and contents of the pack Optimark syringes contain a clear, colourless to pale yellow solution.
Izgled zdravila Optimark in vsebina pakiranja Viale zdravila Optimark vsebujejo prozorno, brezbarvno do svetlo rumeno raztopino.
Effects of Age:
Vpliv starosti:
Most of the side effects observed after the use of Optimark were of mild to moderate intensity and transient in nature.
Neželeni učinki, ki so jih opazili po uporabi zdravila Optimark, so bili večinoma blagi do zmerni in prehodni.
Limited data with other gadolinium contrast agents suggests that for the exclusion of additional cranial metastases in a patient with a known solitary resectable metastasis, an MR exam with the injection of the dose of 300 micromol/kg body weight of Optimark may lead to higher diagnostic confidence.
Omejeni podatki z drugimi kontrastnimi sredstvi, ki vsebujejo gadolinij, kažejo, da lahko pri izločanju kranialnih metastaz pri bolnikih z znano posamezno resektabilno metastazo magnetnoresonančno slikanje z injiciranjem odmerka 300 mikromolov/kg telesne mase zdravila Optimark poveča zanesljivost diagnoze.
Do not use if leakage is observed.
Če opazite uhajanje, brizge ne uporabite.