FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP recognises that within the high risk group the risk of NSF with gadodiamide and gadoversetamide appears higher than with gadopentetic acid based on physicochemical properties, studies in animals and the number of cases of NSF reported.
Slovenian: CHMP je na osnovi fizikalno-kemijskih lastnosti, študij pri živalih in števila poročanih primerov NSF ugotovil, da je v skupini z visokim tveganjem tveganje NSF pri gadodiamidu in gadoversetamidu večje kot pri gadopentetski kislini.
English: [If use is not authorised in children under 2 years add the following statement]
Slovenian: [če uporaba ni odobrena pri otrocih, mlajših od dveh let, je treba dodati naslednje besedilo]
English: Tell your doctor if you are breast-feeding or about to start breast-feeding.
Slovenian: Obvestite zdravnika, če dojite ali boste kmalu začeli dojiti.
English: The use of {Invented name} is not recommended in patients with severe kidney problems and patients who have recently had, or soon expect to have, a liver transplant.
Slovenian: Uporaba zdravila {lastniško ime} ni priporočljiva pri bolnikih s hudimi težavami z ledvicami in bolnikih po nedavni presaditvi ali pred presaditvijo jeter.
English: 287 mg/ml (0,5 mmol/ml) solution for injection intravenous use
Slovenian: 287 mg/ml (0,5 mmol/ml) Raztopina za injiciranje
English: Neonates up to 4 weeks of age, infants up to 1 year of age and children
Slovenian: Novorojenčki do 4 tednov starosti, dojenčki do 1 leta starosti in otroci
English: {Invented name} should not be used during pregnancy unless the clinical condition of the woman requires use of {active substance}.
Slovenian: Zdravila {izmišljeno ime} se ne sme uporabljati med nosečnostjo, razen če je zaradi kliničnega stanja nosečnice uporaba{zdravilne učinkovine}potrebna.
English: The risk for development of NSF in patients with moderate renal impairment (GFR 30-59 ml/min/1.73 m2) is unknown, therefore, {Invented name} should be only used after careful risk-benefit evaluation in patients with moderate renal impairment at a dose not exceeding {x} mmol/kg body weight.
Slovenian: Tveganje za razvoj NSF pri bolnikih z zmerno okvaro ledvic (GFR 30 - 59 ml/min/1,73 m2) ni znano, zato je treba pri bolnikih z zmerno okvaro ledvic zdravilo {Lastniško ime} uporabljati le po skrbni presoji koristi in tveganj v odmerkih, ki ne presagajo {x} mmol/kg telesne mase.
English: Multihance 529 mg/ml solution for injection in prefiled syringe solution for injection in prefilled syringe intravenous use
Slovenian: Multihance 529 mg/ml solution for injection in prefiled syringe
English: Neonates and infants should only receive one dose of {Invented name} during a scan and should not receive a second injection for at least 7 days.
Slovenian: Novorojenčki in dojenčki lahko prejmejo le en odmerek zdravila {lastniško ime} med slikanjem, nato pa mora do naslednjega slikanja miniti vsaj 7 dni.
English: You should not be given {Invented name} if you suffer from severe kidney problems or if you are a patient who is about to have or has recently had a liver transplant.
Slovenian: Zdravila {Lastniško ime} ne smete prejeti, če imate hudo okvaro ledvic ali če ste pred kratkim imeli ali v kratkem pričakujete presaditev jeter.
English: There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of {Invented name} and some other gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30 ml/min/1.73m2).
Slovenian: Poročali so o nefrogeni sistemski fibrozi (NSF), povezani z uporabo zdravila {Lastniško ime} in nekaterih drugih kontrastnih sredstev, ki vsebujejo gadolinij pri bolnikih z akutno ali kronično hudo okvaro ledvic (GFR < 30 ml/min/1,73 m2).
English: Neonates up to 4 weeks of age and infants up to 1 year of age
Slovenian: Novorojenčki do 4. tedna starosti in dojenčki do 1 leta starosti
English: solution for injection syringe intravenous use
Slovenian: Raztopina za injiciranje (syringe) Intravenska uporaba
English: Gadovist 1,0 mmol/ml raztopina za injiciranje
Slovenian: Gadovist 1,0 mmol/ml raztopina za injiciranje 1,0 mmol/ml
English: If use is authorised in neonates and infants add the following statement]
Slovenian: Če se zdravilo odobri za novorojenčke in dojenčke, se doda naslednja izjava]
English: {Invented name} is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and in patients in the perioperative liver transplantation period (see section 4.3).
Slovenian: Zdravilo {Lastniško ime} je kontraindicirano pri bolnikih s hudo okvaro ledvic (glomerulna filtracija (GFR) < 30 ml/min/1,73 m2) in pri bolnikih v perioperativnem obdobju presaditve jeter (glejte poglavje 4.3).
English: However if use is required you should only receive one dose of {Invented name} during a scan and you should not receive a second injection for at least 7 days.
Slovenian: Če pa je uporaba potrebna, lahko prejmete le en odmerek zdravila {lastniško ime} med slikanjem, nato pa mora do naslednjega slikanja miniti vsaj 7 dni.
English: {Invented name} is contraindicated in patients with severe renal impairment (GFR <30ml/min/1.73m2), in patients in the perioperative liver transplantation period and in neonates up to 4 weeks of age (see section 4.4).
Slovenian: Zdravilo {Lastniško ime} je kontraindicirano pri bolnikih s hudo okvaro ledvic (glomerulna filtracija (GFR) < 30 ml/min/1,73 m2), pri bolnikih v perioperativnem obdobju presaditve jeter in pri novorojenčkih do četrtega tedna starosti (glejte poglavje 4.4).
English: [If use is permitted in neonates and infants add a statement on use in neonates and infants]
Slovenian: [Če se dovoli uporaba pri novorojenčkih in dojenčkih, se doda izjava o uporabi pri novorojenčkih in dojenčkih]
English: POSSIBLE SIDE EFFECTS [Use currently approved text with the addition of information on NSF]
Slovenian: MOŽNI NEŽELENI UČINKI [odobreno besedilo z dodatnim besedilom o NSF]
English: {Invented name} should only be used in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with noncontrast enhanced MRI (see section 4.4).
Slovenian: Zdravilo {izmišljeno ime} se lahko uporablja pri bolnikih s hudo okvarjenim delovanjem (GFR <30 ml/min/1,73 m2) in pri bolnikih v perioperativnem obdobju presaditve jeter le po skrbni oceni koristi in tveganja in če je diagnostična informacija ključna ter je ni možno pridobiti z magnetnoresonančnim slikanjem (MRS) brez uporabe kontrastnega sredstva (glejte poglavje 4.4).
English: Due to immature renal function in infants up to 1 year of age, {Invented name} should only be used in these patients after careful consideration at a dose not exceeding {x} mmol/kg body weight.
Slovenian: Zaradi nezrelega delovanja ledvic pri dojenčkih do enega leta starosti, se zdravilo {Lastniško ime} lahko uporablja pri teh bolnikih le po skrbni presoji v odmerkih, ki ne presegajo {x} mmol/kg telesne mase.
English: solution for injection (vial)
Slovenian: Raztopina za injiciranje (viala)
English: There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs) associated with use of other gadolinium-containing contrast agents.
Slovenian: Poročali so o nefrogeni sistemski fibrozi (ki povzroči otrdelost kože in lahko prizadene mehka tkiva ter notranje organe), ki je povezana z uporabo drugih kontrastnih sredstev, ki vsebujejo gadolinij.
English: As there is a possibility that NSF may occur with {Invented name}, it should therefore only be used in patients with severe renal impairment and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI.
Slovenian: Ker obstaja možnost pojava NSF zaradi zdravila {izmišljeno ime}, se ga lahko uporablja pri bolnikih s hudo okvarjenim delovanjem ledvic in bolnikih v perioperativnem obdobju presaditve jeter le po skrbni oceni koristi in tveganja in če je diagnostična informacija ključna ter je ni možno pridobiti z magnetnoresonančnim slikanjem (MRS) brez uporabe kontrastnega sredstva.
English: • your kidneys do not work properly
Slovenian: • imate okvarjeno delovanje ledvic,
English: Use of {Invented name} should be avoided in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI (see section 4.4).
Slovenian: Zdravila {izmišljeno ime} se ne sme uporabiti pri bolnikih s hudo okvarjenim delovanjem ledvic (GFR <30 ml/min/1,73 m2) in bolnikih v perioperativnem obdobju presaditve jeter, razen če je diagnostična informacija ključna ter je ni možno pridobiti z magnetnoresonančnim slikanjem (MRS) brez uporabe kontrastnega sredstva (glejte poglavje 4.4).
English: As there is a possibility that NSF may occur with {Invented name}, it should therefore be avoided in patients with severe renal impairment and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI.
Slovenian: Ker obstaja možnost pojava NSF zaradi zdravila {izmišljeno ime}, se je njegovi uporabi pri bolnikih s hudo okvarjenim delovanjem ledvic in bolnikih v perioperativnem obdobju presaditve jeter treba izogibati, razen če je diagnostična informacija ključna ter je ni možno pridobiti z magnetnoresonančnim slikanjem (MRS) brez uporabe kontrastnega sredstva.
English: [If use is only authorised in infants above the age of 6 months add the following statement]
Slovenian: [Če se zdravilo odobri le za dojenčke, starejše od 6 mesecev, se doda naslednja izjava]
English: RO-Romania
Slovenian: Romunija
English: 4.3 Contraindications [Use currently approved text with addition of contraindication below]
Slovenian: [odobreno besedilo z dodatnimi kontraindikacijami navednimi spodaj]
English: Take special care with {Invented name}: [Use currently approved text with addition of the information on the NSF]
Slovenian: Bodite posebno pozorni pri uporabi zdravila {Lastniško ime} [odobreno besedilo z dodatnim besedilom o NSF]
English: Prior to administration of {Invented name}, all patients should be screened for renal dysfunction by obtaining laboratory tests.
Slovenian: Pred uporabo zdravila {Lastniško ime} je treba pri vseh bolnikih na podlagi laboratorijskih preiskav oceniti delovanje ledvic.
English: [If use is authorised in infants add the following statement]
Slovenian: [Če je odobrena uporaba pri dojenčkih, je treba dodati naslednje besedilo]
English: 287 mg/ml Gadodiamid
Slovenian: 287 mg/ml Gadodiamid Raztopina za injiciranje
English: There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs) most of which were in patients who received {Invented name} together with other gadolinium-containing contrast agents.
Slovenian: Poročali so o nefrogeni sistemski fibrozi (ki povzroči otrdelost kože in lahko prizadene mehka tkiva ter notranje organe), večinoma pri bolnikih, ki so sočasno z zdravilom {lastniško ime} prejeli druga kontrastna sredstva, ki vsebujejo gadolinij.
English: [If use is restricted by age for a particular indication add a statement on use in neonates and infants and specify the indication and age at which use is not recommended]
Slovenian: [Če se uporaba za določeno indikacijo omeji s starostjo, se doda izjava o uporabi pri novorojenčkih in dojenčkih z navedbo indikacije in starosti, pri kateri uporaba ni priporočena]
English: CZ - Czech Republic
Slovenian: Češka
English: [If use is permitted in infants, add a statement on use in infants]
Slovenian: [če je uporaba dovoljena pri dojenčkih, je treba dodati besedilo o uporabi zdravila pri dojenčkih]
English: Due to immature renal function in infants up to 1 year of age, {Invented name} should only be used in patients 6 to 12 months of age after careful consideration.
Slovenian: Zaradi nezrelega delovanja ledvic pri dojenčkih do enega leta starosti, se zdravilo {Lastniško ime} lahko uporablja pri bolnikih v starosti od 6 do 12 mesecev le po skrbni presoji.
English: ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS
Slovenian: DODATEK III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA UPORABO
English: There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs) in patients who received {Invented name} together with other gadolinium-containing contrast agents.
Slovenian: Poročali so o nefrogeni sistemski fibrozi (ki povzroči otrdelost kože in lahko prizadene mehka tkiva ter notranje organe) pri bolnikih, ki so sočasno z zdravilom {lastniško ime} prejeli druga kontrastna sredstva, ki vsebujejo gadolinij.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR LOW RISK GADOLINIUM-CONTAINING CONTRAST AGENTS (gadoteric acid, gadoteridol, gadobutrol)
Slovenian: POPRAVKI, KI MORAJO BITI VKLJUČENI V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA ZA KONTRASTNA SREDSTVA Z GADOLINIJEM Z MAJHNIM TVEGANJEM (gadoterna kislina, gadoteridol, gadobutrol)
English: Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with {Invented name} (see section 4.4).
Slovenian: Po uporabi zdravila {izmišljeno ime} so poročali o posameznih primerih nefrogene sistemske fibroze (NSF) (glejte poglavje 4.4).
English: 0.5 mmol/ml and 0.5 mmol/litre
Slovenian: Omniscan injection 0.5 mmol/ml and 0.5 mmol/litre
English: Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with {Invented name} in patients co-administered other gadolinium-containing contrast agents (see section 4.4).
Slovenian: Po uporabi zdravila {izmišljeno ime} so poročali o posameznih primerih nefrogene sistemske fibroze (NSF) pri bolnikih, ki so sočasno prejeli druga kontrastna sredstva, ki vsebujejo gadolinij (glejte poglavje 4.4).
English: [If use is restricted for use in children greater than 1 year of age, specify the indication and age at which use is not recommended]
Slovenian: [če je uporaba omejena pri otrocih, ki so stari več kot eno leto, je treba opredeliti indikacijo in starost pri kateri se uporaba ne priporoča]
English: [If use is restricted by age for a particular indication, add a statement on use in neonates and infants and specify the indication and age at which use is not recommended]
Slovenian: [če je uporaba pri posamezni indikaciji omejena s starostjo, je treba dodati besedilo o uporabi pri novorojenčkih in dojenčkih in opredeliti indikacijo in starost pri kateri se uporaba ne priporoča]
English: [Use currently approved text with the addition of information on impaired renal function]
Slovenian: [Uporabi se trenutno odobreno besedilo z informacijami o odstranjevanju]
English: DOTAREM 0,5 mmol/ml injection 100ml injection intravenous use
Slovenian: DOTAREM 0,5 mmol/ml injection 100ml
English: • you have recently had, or soon expect to have, a liver transplant
Slovenian: • so vam pred kratkim presadili jetra ali takšen poseg pričakujete v kratkem.
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS
Slovenian: PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODIL ZA UPORABO
English: [Use currently approved text with the addition of information on use in neonates and infants]
Slovenian: [Uporabi se trenutno odobreno besedilo, razen za informacije o okvarjenem delovanju ledvic, uporabi pri novorojenčkih, dojenčkih in starostnikih]
English: Gadovist 1.0 mmol/ml Solution for Injection in prefilled cartridge solution for injection, in prefilled cartridge intravenous use
Slovenian: Gadovist 1.0 mmol/ml Solution for Injection in prefilled cartridge
English: As kidney function is immature in infants up to 1 year of age, {Invented name} will only be used in patients 6 to 12 months of age after careful consideration by the doctor.
Slovenian: Zaradi nezrelega delovanja ledvic pri dojenčkih do enega leta starosti, se bo zdravilo {Lastniško ime} pri bolnikih v starosti od 6 do 12 mesecev uporabilo le po skrbni presoji zdravnika.
English: [If use is permitted in neonates and infants, add a statement on use in neonates and infants]
Slovenian: [če je uporaba dovoljena pri novorojenčkih in dojenčkih, je treba dodati besedilo o uporabi zdravila pri novorojenčkih in dojenčkih]
English: Continuing breast feeding or discontinuing {Invented name} for a period of 24 hours after administration, should be at the discretion of the doctor and lactating mother.
Slovenian: Zdravnik in mati, ki doji, se odločita o nadaljevanju ali prekinitvi dojenja za 24 ur po uporabi zdravila {izmišljeno ime}.
English: 4.4 Special warnings and precautions for use [With the exception of information on impaired renal function, use in neonates and infants and use in the elderly, use currently approved text]
Slovenian: [odobreno besedilo, razen podatkov glede motenega delovanja ledvic, uporabe pri novorojenčkih in dojenčkih ter uporabe pri starejših bolnikih]
English: Primovist 0.25 mmol/ml Sol for Injection, prefilled syringe solution for injection, prefilled syringe intravenous use
Slovenian: Primovist 0.25 mmol/ml Sol for Injection, prefilled syringe
English: Primovist 0,25 mmol/ ml, injekčný roztok
Slovenian: Primovist 0,25 mmol/ ml, injekčný roztok 0,25 mmol/ml
English: Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, {Invented name} should only be used in these patients after careful consideration.
Slovenian: Zaradi nerazvite ledvične funkcije pri novorojenčkih do 4 tednov starosti in dojenčkih do 1 leta starosti se lahko zdravilo{lastniško ime} pri teh bolnikih uporablja le po skrbni presoji zdravnika.
English: Due to immature renal function in infants up to 1 year of age, {Invented name} should only be used in these patients after careful consideration.
Slovenian: Zaradi nezrelega delovanja ledvic pri dojenčkih do enega leta starosti, se zdravilo {Lastniško ime} lahko uporablja pri teh bolnikih le po skrbni presoji.
English: [If use is restricted for use in children greater than 1 year of age specify the indication and age at which use is not recommended]
Slovenian: [Če se omeji uporaba za otroke, starejše od 1 leta, se doda navedba indikacije in starosti, pri kateri uporaba ni priporočena]
English: Box 4220 Nydalen, N-0401 Oslo Norway
Slovenian: P.O. Box 4220 Nydalen, N-0401 Oslo Norway
English: Omniscan 0.5mmol/ml solution for injection, prefilled syringe solution for injection, prefilled syringe intravenous use
Slovenian: Omniscan 0.5mmol/ml solution for injection, prefilled syringe
English: Take special care with {Invented name}: [Use currently approved text with the addition of information on impaired renal function, use in neonates and infants and use in the elderly]
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE PREJELI ZDRAVILO {lastniško ime} Bodite posebno pozorni pri uporabi zdravila {lastniško ime}: [Uporabi se trenutno odobreno besedilo z dodatkom informacije o okvarjenem delovanju ledvic, uporabi pri novorojenčkih, dojenčkih in starostnikih] Obvestite svojega zdravnika, če:
English: 4.2 Posology and method of administration [Use currently approved text with the addition of guidance for special populations (patients with renal impairment, neonates, infants and the elderly)]
Slovenian: [Uporabi se trenutno odobreno besedilo z dodatkom priporočil za posebne populacije (bolniki z okvarjenim delovanjem ledvic, novorojenčki, dojenčki in starostniki)]
English: Omniscan 0,5 mmol/ml raztopina za injiciranje
Slovenian: Omniscan 0,5 mmol/ml raztopina za injiciranje 0,5 mmol/ml
English: IS - Iceland
Slovenian: Islandija
English: PL - Poland
Slovenian: Poljska
English: Cases of nephrogenic systemic fibrosis (NSF) have been reported with other gadolinium-containing contrast agents (see section 4.4).
Slovenian: Po uporabi kontrastnih sredstev, ki vsebujejo gadolinij, so poročali o primerih nefrogene sistemske fibroze (NSF) (glejte poglavje 4.4).
English: Box 4220 Nydalen, Oslo N-0401
Slovenian: P.O. Box 4220 Nydalen, Oslo N-0401
English: Gadovist 1.0 mmol/ml Solution for Injection in prefilled syringe solution for injection, in prefilled syringe intravenous use
Slovenian: Gadovist 1.0 mmol/ml Solution for Injection in prefilled syringe
English: {Invented name} should not be used in newborn babies up to the age of 4 weeks.
Slovenian: Zdravila {Lastniško ime} se ne sme uporabljati pri novorojenčkih do četrtega tedna starosti.
English: {Invented name} should also not be used in newborn babies up to the age of 4 weeks.
Slovenian: Zdravila {Lastniško ime} se ne sme uporabljati tudi pri novorojenčkih do četrtega tedna starosti.
English: Breast-feeding should be discontinued for at least 24 hours after the administration of {Invented name}.
Slovenian: Po aplikaciji zdravila {Lastniško ime} je treba dojenje prekiniti za najmanj 24 ur.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR MEDIUM RISK GADOLINIUM-CONTAINING CONTRAST AGENTS (gadoxetic acid, gadobenic acid)
Slovenian: POPRAVKI, KI MORAJO BITI VKLJUČENI V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA ZA KONTRASTNA SREDSTVA Z GADOLINIJEM S SREDNJIM TVEGANJEM (gadoksetna kislina, gadobenska kislina)
English: DOTAREM 0,5 mmol/ml injection 60ml injection intravenous use
Slovenian: DOTAREM 0,5 mmol/ml injection 60ml 0,5 mmol/ml
English: {Invented name} should also not be given to newborn babies up to the age of 4 weeks.
Slovenian: Zdravila {Lastniško ime} prav tako ne smejo prejeti novorojenčki do četrtega tedna starosti.
English: Multihance 0.5 M solution for injection
Slovenian: Multihance 0.5 M solution for injection 529 mg/ml
English: Cases of nephrogenic systemic fibrosis (NSF) have been reported with {Invented name} (see section
Slovenian: Pri uporabi zdravila {Lastniško ime} so poročali o primerih nefrogene sistemske fibroze (NSF) (glejte poglavje 4.4)
English: DOTAREM 0,5 mmol/ml injection 15ml injection intravenous use
Slovenian: DOTAREM 0,5 mmol/ml injection 15ml 0,5 mmol/ml
English: Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with {Invented name}, most of which were in patients co-administered other gadolinium-containing contrast agents (see section or
Slovenian: Po uporabi zdravila {izmišljeno ime} so poročali o posameznih primerih nefrogene sistemske fibroze (NSF) večinoma pri bolnikih, ki so sočasno prejeli druga kontrastna sredstva, ki vsebujejo gadolinij (glejte poglavje 4.4).
English: SE - Sweden
Slovenian: Švedska
English: Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, {Invented name} should only be used in these patients after careful consideration at a dose not exceeding {X} mmol/kg body weight.
Slovenian: Zdravilo {izmišljeno ime} se lahko zaradi nerazvite ledvične funkcije pri novorojenčkih do 4 tednov starosti in dojenčkih do 1 leta starosti uporablja le po skrbni presoji in v odmerku, ki ne presega {x} mmol/kg telesne mase.
English: solution for injection in pre-filled syringe intravenous use
Slovenian: Raztopina za injiciranje v vložku Intravenska uporaba
English: Solution for injection (pre-filled syringe)
Slovenian: Raztopina za injiciranje, (Iijekcijska brizga, vložek)
English: BE - Belgium
Slovenian: Belgija
English: DOTAREM 0,5 mmol/ml injection 20ml injection intravenous use
Slovenian: DOTAREM 0,5 mmol/ml injection 20ml 0,5 mmol/ml
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR HIGH RISK GADOLINIUM-CONTAINING CONTRAST AGENTS (gadodiamide, gadopentetic acid)
Slovenian: DODATEK BO VKLJUČEN V USTREZNA POGLAVJA POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVIL, KI VSEBUJEJO GADOLINIJ IN PRI KATERIH OBSTAJA VISOKA STOPNJA TVEGANJA (gadodiamid, gadopentetna kislina)
English: 4.9 Overdose [Use currently approved text with the addition of haemodialysis wording]
Slovenian: [Uporabi se trenutno odobreno besedilo z dodatkom besedila o hemodializi]