FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: • 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.
English: Children and adolescents Optimark is not recommended in children who are below the age of two years.
Slovenian: Otroci in mladostniki Uporaba zdravila Optimark pri otrocih, mlajših od dveh let, se ne priporoča.
English: It is unknown whether gadoversetamide is excreted in human milk.
Slovenian: Ni znano, ali se gadoversetamide izloča v materino mleko.
English: The agent should be administered as a bolus peripheral intravenous injection at a dose of 0.2 ml/kg (100 micromol/kg) body weight.
Slovenian: Sredstvo je treba uporabiti v obliki bolusne periferne intravenske injekcije z odmerkom 0,2 ml/kg (100 mikromolov/kg) telesne mase.
English: In patients with compromised renal function, clearance of gadoversetamide will be slowed and the interference with calcium determination by OCP prolonged.
Slovenian: Pri bolnikih z okvarjenim delovanjem ledvic je očistek gadoversetamida upočasnjen, motnja meritev kalcija z metodo OCP pa dolgotrajnejša.
English: Nasal congestion, Throat irritation
Slovenian: Nosna kongestija, draženje grla
English: In patients with baseline renal impairment, acute kidney injury requiring dialysis has occurred with the use of Optimark.
Slovenian: Pri bolnikih z izhodiščno okvaro ledvic je pri uporabi zdravila Optimark prišlo do akutne poškodbe ledvic, ki je zahtevala dializo.
English: 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).
Slovenian: 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).
English: • The active substance is gadoversetamide.
Slovenian: • Zdravilna učinkovina je gadoversetamid.
English: • Hypersensitivity to gadoversetamide or to other gadolinium containing products or to any of the excipients.
Slovenian: • Preobčutljivost za gadoversetamid, za druga zdravila, ki vsebujejo gadolinij, ali katero koli pomožno snov.
English: 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.
Slovenian: Zaradi pomanjkanja podatkov o ponavljajočem odmerjanju je ponovno injiciranje zdravila Optimark dovoljeno šele po poteku časovnega presledka 7 dni.
English: • you suffer from allergies (e.g. medicinal products, seafood, hay fever, hives) or asthma
Slovenian: • imate alergijo (npr. na zdravila, morsko hrano, seneni nahod ali koprivnico) ali astmo;
English: Not all package sizes may be marketed.
Slovenian: Na trgu morda ni vseh navedenih pakiranj.
English: Syringe tip cap and piston are made of bromobutyl rubber.
Slovenian: Zaporka konice in bat brizge sta izdelana iz bromobutilne gume.
English: Neonates and infants
Slovenian: Novorojenčki in dojenčki
English: In patients with moderate kidney problems, more than one dose of Optimark should not be used during a scan.
Slovenian: Pri bolnikih z zmernimi težavami z ledvicami med slikanjem ni dovoljeno uporabiti več kot enega odmerka zdravila Optimark.
English: Serum iron and zinc
Slovenian: Železo in cink v serumu
English: Optimark should not be used in children below the age of two years.
Slovenian: Zdravilo Optimark se ne sme uporabljati pri otrocih, mlajših od dveh let.
English: Optimark contains sodium
Slovenian: Zdravilo Optimark vsebuje natrij
English: swelling around the eyes, abnormal ECG heart tracing, fainting, vomiting
Slovenian: otekanje okrog oči, nenormalni izvidi EKG, omedlevica, bruhanje
English: 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.
Slovenian: 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
English: Inspect the syringe for signs of leakage.
Slovenian: Preverite, ali obstajajo kakršnikoli znaki uhajanja raztopine iz brizge.
English: 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
Slovenian: - 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.
English: Optimark is contraindicated in neonates up to 4 weeks of age.
Slovenian: Zdravilo Optimark je kontraindicirano pri novorojencih do starosti 4 tednov.
English: 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.
Slovenian: 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.
English: Chest discomfort, Chest pain, Feeling cold (including peripheral coldness), Administration site reactions
Slovenian: Občutek neugodja v prsnem košu, bolečina v prsnem košu, občutek mraza (vključno s hladnimi okončinami, reakcije na mestu aplikacije
English: Optimark has been shown to cause interference in the measurement of serum calcium using the orthocresolphthalein complexone (OCP) colorimetric method.
Slovenian: Pokazalo se je, da zdravilo Optimark povzroča motnje pri merjenju kalcija v serumu s kolorimetrično metodo s kompleksonom orto-krezolftaleina (OCP).
English: The most common adverse reactions were dysgeusia, feeling hot, headache and dizziness.
Slovenian: Najpogostejši neželeni učinki so bili disgevzija, občutek vročine, glavobol in omotica.
English: Optimark is contraindicated in neonates up to 4 weeks of age (see section 4.3).
Slovenian: Zdravilo Optimark je kontraindicirano pri novorojencih do starosti 4 tednov (glejte poglavje 4.3).
English: Gadoversetamide is used as a ‘contrast agent' in magnetic resonance imaging.
Slovenian: Gadoversetamid se uporablja kot kontrastno sredstvo pri magnetnoresonančnem slikanju.
English: 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).
Slovenian: Te reakcije se lahko pokažejo v obliki kardiovaskularnih, respiratornih ali kožnih reakcij (glejte poglavje 4.8).
English: • 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.
Slovenian: • 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.
English: • neonates up to 4 weeks of age.
Slovenian: • pri novorojenčkih, starih do 4 tedne.
English: Special precautions for disposal and other handling Optimark is intended for single use only; any unused portions should be discarded.
Slovenian: Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravilo Optimark je namenjeno enkratni uporabi; neuporabljeno zdravilo zavrzite.
English: Palpitations, AV block first Tachycardia, Arrhythmia
Slovenian: Palpitacije, AV-blok prve stopnje, ekstrasistole, tahikardija, aritmija
English: Optimark must not be administered with an autoinjector to children of 2 to 11 years (see section 4.4).
Slovenian: Otrokom, starih od 2 do 11 let, se zdravila Optimark ne sme dati z avtoinjektorjem (glejte poglavje 4.4).
English: 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.
Slovenian: Za takojšnje ukrepanje v nujnih primerih morajo biti na voljo nujna zdravila (npr. epinefrin/adrenalin, teofilin, antihistaminiki, kortikosteroidi in atropini), endotrahealni tubus in respirator.
English: Blood calcium abnormal
Slovenian: Nenormalne vrednosti kalcija v krvi
English: Especially in patients with serious heart diseases (e.g. severe heart failure, coronary artery disease) cardiovascular reactions may deteriorate.
Slovenian: Kardiovaskularne reakcije se lahko poslabšajo zlasti pri bolnikih z resnimi srčnimi boleznimi (npr. hudo srčno popuščanje, koronarna srčna bolezen).
English: The MAH shall submit annual cumulative reviews on nephrogenic systemic fibrosis (NSF) cases.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo predložil letne kumulativne preglede primerov nefrogene sistemske fibroze (NFS).
English: June 2018
Slovenian: Končno poročilo o študiji: junija 2018
English: 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
Slovenian: 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
English: The vials are fitted with bromobutyl rubber closures, aluminium cap seals, and plastic flip caps.
Slovenian: Na vialah so pokrovi iz bromobutilne gume, aluminijasta tesnila in plastični pokrovčki.
English: What Optimark looks like and contents of the pack Optimark syringes contain a clear, colourless to pale yellow solution.
Slovenian: Izgled zdravila Optimark in vsebina pakiranja Viale zdravila Optimark vsebujejo prozorno, brezbarvno do svetlo rumeno raztopino.
English: Effects of Age:
Slovenian: Vpliv starosti:
English: Most of the side effects observed after the use of Optimark were of mild to moderate intensity and transient in nature.
Slovenian: Neželeni učinki, ki so jih opazili po uporabi zdravila Optimark, so bili večinoma blagi do zmerni in prehodni.
English: 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.
Slovenian: 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.
English: Do not use if leakage is observed.
Slovenian: Če opazite uhajanje, brizge ne uporabite.
English: decreased appetite, feeling anxious, sleep disorder, drowsy feeling, burning sensation, a sensation of movement or spinning, ringing in the ears, eyelid redness, eye pain, vision blurred, bloodshot eyes, awareness of the heartbeat, irregular heartbeats, extra heartbeats, low blood pressure, shortness of breath, hoarseness, runny nose, throat constriction, mouth watering, abdominal pain, constipation, dry mouth, hives, cold sweat, redness, higher blood level of a substance (creatinine) usually eliminated by the kidneys, blood in urine, face swollen, weakness and similar symptoms like fatigue and general feeling of being unwell, fever, swelling in limbs, chill, pain, cold feeling in extremities, liver enzyme increased, urine analysis abnormal, mineral values in urine increased, protein in urine, heart and muscle enzyme increased, decreased haemoglobin, feeling confused and disoriented, shaking, convulsion, pink eye, fast heart beat, high blood pressure, tightening of the airways, swollen throat or voice box, raw throat, cough, itchy nose, sneezing, sweating
Slovenian: zmanjšan apetit, občutek tesnobe, motnje spanja, dremavost, pekoč občutek, občutek gibanja ali vrtenja, zvenenje v ušesih, rdečica vek, bolečine v očeh, zamegljen vid, krvave oči, zavedanje bitja srca, nepravilen srčni utrip, dodatni srčni utripi, nizek krvni tlak, kratka sapa, hripavost, izcedek iz nosu, stiskanje grla, povečano izločanje sline, bolečina v trebuhu, zaprtje, suha usta, koprivnica, hladen pot, rdečica, zvišana raven snovi, ki se po navadi izloča skozi ledvice
English: It provides contrast enhancement and facilitates visualization and helps with the characterization of focal lesions and abnormal structures in the CNS and liver in adult patients and in children of two years and older with known or highly suspected pathology.
Slovenian: Omogoča krepitev kontrasta ter izboljša prikaz in pomaga pri karakterizaciji fokalnih lezij in nenormalnih struktur v osrednjem živčevju in jetrih odraslih bolnikov in otrok, starih dve leti ali več, z znano patologijo ali močnim sumom nanjo.
English: Use of Optimark is not recommended in children less than 2 years of age because the safety, efficacy, and impact of immature kidney function have not been studied in this age group.
Slovenian: Optimark ni priporočena pri otrocih, mlajših od dveh let, saj varnosti, učinkovitosti in vpliva na delovanje nerazvitih ledvic pri tej starostni skupini niso raziskovali.
English: Gadoversetamide has been shown to cause interference in the measurement of serum calcium using the ortho-cresolphthalein complexone (OCP) colorimetric method.
Slovenian: Pokazalo se je, da gadoversetamid povzroča motnje pri merjenju kalcija v serumu s kolorimetrično metodo s kompleksonom orto-krezolftaleina (OCP).
English: Cases of gadolinium associated skin plaques, with demonstrated sclerotic bodies on histology, have been reported with some gadolinium-containing contrast agents in patients who do not otherwise have symptoms or signs of nephrogenic systemic fibrosis.
Slovenian: Pri nekaterih kontrastnih sredstvih, ki vsebujejo gadolinij, so pri bolnikih, ki drugače nimajo simptomov ali znakov nefrogene sistemske fibroze, poročali o primerih z gadolinijem povezanih kožnih plakov s histološkimi dokazi skleroznih teles.
English: Solution for injection in pre-filled syringe 10 ml (1, 10 syringes)
Slovenian: raztopina za injiciranje v napolnjeni injekcijski brizgi 10 ml (1, 10 brizg)
English: • in patients with severe renal impairment (GFR <30ml/min/1.73m2) and/or acute kidney injury,
Slovenian: • pri bolnikih s hudo ledvično okvaro (GFR < 30 ml/min/1,73m²) in/ali akutno poškodbo ledvic,
English: Treatment should be symptomatic and immediate access to necessary medicinal products and emergency equipment should be available should a serious event occur.
Slovenian: Če pride do resnega neželenega učinka, mora biti zdravljenje simptomatsko, na voljo pa morajo biti nujna zdravila in oprema za nujno ukrepanje.
English: It is used in adult patients and children of two years and older, who are undergoing magnetic resonance imaging (MRI), a type of scan where images of the internal organs are taken.
Slovenian: Uporablja se pri odraslih in otrocih, starih dve leti ali več, ki bodo slikani z magnetno resonanco (MR).
English: • you have recently had, or soon expect to have, a liver transplant
Slovenian: • če so vam pred kratkim presadili jetra ali vam jih v kratkem bodo;
English: Solution for injection in vial 10 ml (1, 10 vials)
Slovenian: raztopina za injiciranje v viali 10 ml (1, 10 vial)
English: Optimark can be removed using dialysis.
Slovenian: Zdravilo Optimark je mogoče odstraniti iz krvi z dializo.
English: 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
Slovenian: Ko palico za potiskanje navijete na bat brizge, morate palico za potiskanje zaviti še za polovico obrata, tako da se sivi bat prosto obrača.
English: Most of the adverse reactions were of mild to moderate intensity and transient in nature.
Slovenian: Neželeni učinki so bili večinoma blagi do zmerni in prehodni.
English: Lesion conspicuity of hypo- and hypervascular lesions may be reduced if imaging is delayed more than 3 minutes due to the diffusion of the contrast agent into the interstitial spaces of both the liver parenchyma and lesion (e.g. metastasis) making the lesion isointense with the normal liver parenchyma.
Slovenian: Vidnost hipo- in hipervaskularnih lezij je lahko zaradi difuzije kontrastnega sredstva v intersticijski prostor jetrnega parenhima in lezij (npr. metastaz) zmanjšana, če slikanje zamuja več kot tri minute, zaradi česar so lezije enako krepke kot normalni jetrni parenhim.
English: • The other ingredients are: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/or hydrochloric acid, water for injections.
Slovenian: • Druge sestavine zdravila so: versetamid, kalcijev hidroksid, kalcijev klorid dihidrat, natrijev hidroksid in/ali klorovodikova kislina, voda za injekcije.
English: Assembly and Inspection
Slovenian: Sestava in pregled:
English: 30 ml of the solution contain 43.13 mg sodium.
Slovenian: 30 ml raztopine vsebuje 43,13 mg natrija.
English: Syringe is now ready for needle or infusion tubing attachment.
Slovenian: Na brizgo lahko sedaj namestite iglo ali cev za infundiranje.
English: Skin and Subcutaneous Tissue Disorders
Slovenian: Bolezni kože in podkožja
English: How to store Optimark
Slovenian: Kako se daje zdravilo Optimark
English: < 30ml/min/1.73 m2) and/or acute kidney injury, in
Slovenian: 30 ml/min/1,73m2) in/ali akutno poškodbo ledvic,
English: Pre-filled syringe Solution for injection in pre-filled syringe.
Slovenian: Napolnjena injekcijska brizga raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Optimark Vsebina pakiranja in dodatne informacije
English: Respiratory, Thoracic and Mediastinal Disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora
English: Prior to administration of Optimark, all patients should be screened for renal dysfunction by obtaining laboratory tests.
Slovenian: Bolniki z okvarjenim delovanjem ledvic Pred apliciranjem zdravila Optimark je treba pri vseh bolnikih z laboratorijskimi preiskavami ugotoviti morebitno ledvično disfunkcijo.
English: Optimark pre-filled syringes are supplied in the following package sizes: 1 x 10 ml 10 x 10 ml
Slovenian: Napolnjene brizge zdravila Optimark so na voljo v naslednjih velikostih pakiranja: 1 x 10 ml
English: Very rare (may affect up to 1 in 10,000 people)
Slovenian: Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):
English: In cranial MRI, if a strong clinical suspicion of a lesion persists despite a single dose contrastenhanced 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 0.2 ml/kg (100 micromol/kg) may be administered within 30 minutes of the first injection as it may increase the diagnostic yield of the examination.
Slovenian: Pri magnetnoresonančnem slikanju lobanje se lahko, če močan klinični sum na lezijo ne izgine kljub enkratnem odmerku kontrastnega sredstva ali kadar lahko natančnejša informacija o številu, velikosti ali obsegu lezij vpliva na obravnavanje ali zdravljenje bolnika, pri osebah z normalnim delovanjem ledvic v 30 minutah po prvem injiciranju uporabi druga bolusna injekcija z odmerkom 0,2 ml/kg
English: Caution should be exercised because transient decreases in serum iron and zinc parameters have been observed in clinical trials.
Slovenian: V kliničnih preskušanjih so opazili prehodno znižanje parametrov železa in cinka, zato je treba biti previden.
English: Vial Solution for injection in vial.
Slovenian: Viala raztopina za injiciranje v viali
English: Optimark is supplied in vials, fitted with bromobutyl rubber closures and aluminium cap seals.
Slovenian: Zdravilo Optimark je na voljo v vialah, na katerih so pokrovi iz bromobutilne gume in aluminijasta tesnila.
English: Nausea, Diarrhoea
Slovenian: Navzea, diareja
English: Excipients: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/or hydrochloric acid, water for injections.
Slovenian: Pomožne snovi: versetamid, kalcijev hidroksid, kalcijev klorid dihidrat, natrijev hidroksid in/ali klorovodikova kislina, voda za injekcije.
English: Optimark vials are supplied in the following package sizes: 1 x 10 ml 10 x 10 ml
Slovenian: Viale zdravila Optimark so na voljo v naslednjih velikostih pakiranja: 1 x 10 ml
English: Salivary hypersecretion,, Abdominal pain, Constipation, Dry mouth
Slovenian: Prekomerno izločanje sline, bolečina v trebuhu, obstipacija, suha usta
English: GENERAL CLASSIFICATION FOR SUPPLY Subject to medical prescription.
Slovenian: Predpisovanje in izdaja zdravila je le na recept.
English: Effect of Renal Impairment
Slovenian: Vpliv ledvične okvare:
English: 20 ml of the solution contain 28.75 mg sodium.
Slovenian: 20 ml raztopine vsebuje 28,75 mg natrija.
English: Rhinorrhoea, Throat tightness, Laryngeal/pharyngeal oedema, Pharyngitis, Rhinitis, Sneezing
Slovenian: Dispneja, disfonija, , rinoreja, stiskanje v grlu, bronhospazem, kašelj, edem larinksa/farinksa, faringitis, rinitis,
English: Pruritus, Rash
Slovenian: Pruritus, izpuščaj
English: Headache, Dysgeusia
Slovenian: Glavoboli, disgevzija
English: • you suffer from epilepsy or brain lesions
Slovenian: • imate epilepsijo ali lezije v možganih; • ste na dieti z malo natrija
English: The following adverse reactions have been reported from clinical trials and from post-marketing use of gadoversetamide.
Slovenian: V kliničnih preskušanjih in ob uporabi gadoversetamida v obdobju trženja so poročali o naslednjih neželenih učinkih.
English: • in patients who have had liver transplantation or
Slovenian: • pri bolnikih, pri katerih so opravili presaditev jeter ali
English: Breast-feeding should be discontinued for at least 24 hours after the administration of Optimark.
Slovenian: Po uporabi zdravila Optimark je treba prenehati z dojenjem za vsaj 24 ur.
English: General Disorders and Administration Site Conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije
English: As a result, these agents have been referred to as markers for sites of abnormal BBB breakdown.
Slovenian: Zato so ta sredstva označevalci mest nenormalnega razkroja krvno-možganske pregrade.
English: No dose adjustment is considered necessary in children more than 2 years of age.
Slovenian: Prilagoditev odmerka pri otrocih, starih več kot 2 leti, ni potrebna.
English: Vial 20 ml of the solution contain 28.75 mg sodium.
Slovenian: Viala 20 ml raztopine vsebuje 28,75 mg natrija.
English: Metabolism and Nutrition Disorders
Slovenian: Presnovne in prehranske motnje
English: Nonclinical data did not reveal special hazards for humans based on conventional studies of reproductive toxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.