natgillin/translations-raw huggingface dataset:
Moxidectin is slowly eliminated from plasma (half-life of approximately 11 days) via biliary excretion and elimination through the faeces with minor contributions of metabolic clearance.
Moksidektin se počasi izloča iz plazme (razpolovna doba je približno 11 dni) z žolčem in blatom z manjšimi prispevki metaboličnega očistka.
The veterinary medicinal product is exclusively indicated when use against ticks or fleas and gastrointestinal nematodes is indicated at the same time.
Zdravilo za uporabo v veterinarski medicini je izključno indicirano, kadar je indicirana sočasna uporaba proti klopom ali bolham in gastrointestinalnim nematodom.
Butylhydroxytoluene (E321) Pigment blend 018 (E110, E129, E132) Hydroxypropylcellulose Silica, colloidal anhydrous Magnesium stearate Maize starch
Seznam pomožnih snovi hipromeloza laktoza monohidrat natrijev karboksimetilškrob tip A meglumin butilhidroksitoluen (E321) pigmentna mešanica 018 (E110, E129, E132) hidroksipropilceluloza silicijev dioksid, koloidni, brezvodni magnezijev stearat koruzni škrob saharoza glukoza, tekoča aroma svinjskih jeter hidrolizirani rastlinski protein želatina pšenični kalčki kalcijev hidrogenfosfat, brezvodni
Tablet is debossed with the sarolaner strength on one face of the tablet.
Na eni strani tablete je vtisnjena jakost sarolanerja.
A reddish-brown colored, pentagon shaped tablet with rounded edges.
Rdečkasto rjavo obarvana tableta v obliki peterokotnika z zaobljenimi robovi.
− For the treatment of tick infestations.
− Za zdravljenje infestacij s klopi.
Sarolaner exhibits higher functional potency to block insect/acarine receptors compared to mammalian receptors.
Sarolaner ima večjo funkcionalno moč za blokado receptorjev pri insektih in pršicah kot pri receptorjih sesalcev.
Moxidectin is active against adults of Toxocara canis, L4 larvae and immature stages (L5) of Ancylostoma caninum, L4 of Dirofilaria immitis and immature stages (L5) of Angiostrongylus vasorum.
Moksidektin je učinkovit proti odraslim nematodom Toxocara canis, ličinkam L4 in nezrelim stopnjam (L5) nematodov Ancylostoma caninum, L4 Dirofilaria immitis in nezrelim stopnjam (L5) nematodov Angiostrongylus vasorum.
− Ancylostoma caninum L4 larvae, immature adults (L5) and adults;
− Ancylostoma caninum ličinke L4, nezreli odrasli (L5) in odrasli nematodi;
sarolaner 3 mg/moxidectin 0.06 mg/pyrantel (as embonate) 12.5 mg sarolaner 6 mg/moxidectin 0.12 mg/pyrantel (as embonate) 25 mg sarolaner 12 mg/moxidectin 0.24 mg/pyrantel (as embonate) 50 mg sarolaner 24 mg/moxidectin 0.48 mg/pyrantel (as embonate) 100 mg sarolaner 48 mg/moxidectin 0.96 mg/pyrantel (as embonate) 200 mg sarolaner 72 mg/moxidectin 1.44 mg/pyrantel (as embonate) 300 mg
sarolaner 3 mg/moksidektin 0,06 mg/pirantel (kot embonat) 12,5 mg sarolaner 6 mg/moksidektin 0,12 mg/pirantel (kot embonat) 25 mg sarolaner 12 mg/moksidektin 0,24 mg/pirantel (kot embonat) 50 mg sarolaner 24 mg/moksidektin 0,48 mg/pirantel (kot embonat) 100 mg sarolaner 48 mg/moksidektin 0,96 mg/pirantel (kot embonat) 200 mg sarolaner 72 mg/moksidektin 1,44 mg/pirantel (kot embonat) 300 mg
For the treatment of gastrointestinal roundworm and hookworm infections:
Za zdravljenje infestacij z gastrointestinalnimi valjastimi in kavljastimi črvi:
EU/2/19/243/001 (3 mg / 0.06 mg / 12.5 mg, 1 tablet) EU/2/19/243/002 (3 mg / 0.06 mg / 12.5 mg, 3 tablets) EU/2/19/243/003 (3 mg / 0.06 mg / 12.5 mg, 6 tablets) EU/2/19/243/004 (6 mg / 0.12 mg / 25 mg, 1 tablet) EU/2/19/243/005 (6 mg / 0.12 mg / 25 mg, 3 tablets) EU/2/19/243/006 (6 mg / 0.12 mg / 25 mg, 6 tablets) EU/2/19/243/007 (12 mg / 0.24 mg / 50 mg, 1 tablet) EU/2/19/243/008 (12 mg / 0.24 mg / 50 mg, 3 tablets) EU/2/19/243/009 (12 mg / 0.24 mg / 50 mg, 6 tablets)
EU/2/19/243/001 (3 mg / 0.06 mg / 12.5 mg, 1 tableta) EU/2/19/243/002 (3 mg / 0.06 mg / 12.5 mg, 3 tablete) EU/2/19/243/003 (3 mg / 0.06 mg / 12.5 mg, 6 tablet) EU/2/19/243/004 (6 mg / 0.12 mg / 25 mg, 1 tableta) EU/2/19/243/005 (6 mg / 0.12 mg / 25 mg, 3 tablete) EU/2/19/243/006 (6 mg / 0.12 mg / 25 mg, 6 tablet) EU/2/19/243/007 (12 mg / 0.24 mg / 50 mg, 1 tableta) EU/2/19/243/008 (12 mg / 0.24 mg / 50 mg, 3 tablete) EU/2/19/243/009 (12 mg / 0.24 mg / 50 mg, 6 tablet) EU/2/19/243/010 (24 mg / 0.48 mg / 100 mg, 1 tableta) EU/2/19/243/011 (24 mg / 0.48 mg / 100 mg, 3 tablete)
− Toxocara canis immature adults (L5) and adults;
− Toxocara canis nezreli odrasli (L5) in odrasli nematodi;
EU/2/19/243/010 (24 mg / 0.48 mg / 100 mg, 1 tablet) EU/2/19/243/011 (24 mg / 0.48 mg / 100 mg, 3 tablets) EU/2/19/243/012 (24 mg / 0.48 mg / 100 mg, 6 tablets) EU/2/19/243/013 (48 mg / 0.96 mg / 200 mg, 1 tablet) EU/2/19/243/014 (48 mg / 0.96 mg / 200 mg, 3 tablets) EU/2/19/243/015 (48 mg / 0.96 mg / 200 mg, 6 tablets) EU/2/19/243/016 (72 mg / 1.44 mg / 300 mg, 1 tablet) EU/2/19/243/017 (72 mg / 1.44 mg / 300 mg, 3 tablets) EU/2/19/243/018 (72 mg / 1.44 mg / 300 mg, 6 tablets)
EU/2/19/243/012 (24 mg / 0.48 mg / 100 mg, 6 tablet) EU/2/19/243/013 (48 mg / 0.96 mg / 200 mg, 1 tableta) EU/2/19/243/014 (48 mg / 0.96 mg / 200 mg, 3 tablete) EU/2/19/243/015 (48 mg / 0.96 mg / 200 mg, 6 tablet) EU/2/19/243/016 (72 mg / 1.44 mg / 300 mg, 1 tableta) EU/2/19/243/017 (72 mg / 1.44 mg / 300 mg, 3 tablete) EU/2/19/243/018 (72 mg / 1.44 mg / 300 mg, 6 tablet)
Tablet strength 72 mg/1.44 mg/300 mg
Jakost tablete 72 mg/1,44 mg/300 mg
The veterinary medicinal product has immediate and persistent tick killing activity for 5 weeks against Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus and for 4 weeks against Dermacentor reticulatus;
Zdravilo za uporabo v veterinarski medicini ima takojšen in trajen učinek ubijanja klopov najmanj 5 tednov za klope vrst Ixodes hexagonus, Ixodes ricinus in
Tablet strength 48 mg/0.96 mg/200 mg
Jakost tablete 48 mg/0,96 mg/200 mg
(L5) stages of Angiostrongylus vasorum.
nematodi Angiostrongylus vasorum.
Tablet strength 24 mg/0.48 mg/100 mg
Jakost tablete 24 mg/0,48 mg/100 mg
Lot {number}
ŠTEVILKA SERIJE Lot{številka}
− Uncinaria stenocephala adults.
− Toxascaris leonina odrasli nematodi; − Uncinaria stenocephala odrasli nematodi.
Excipients:
Učinkovine:
Tablet strength 12 mg/0.24 mg/50 mg
Jakost tablete 12 mg/0,24 mg/50 mg
for dogs 1.25-2.5 kg for dogs >2.5-5 kg for dogs >5-10 kg for dogs >10-20 kg for dogs >20-40 kg for dogs >40-60 kg
za pse 1,25 - 2,5 kg za pse > 2,5 - 5 kg za pse > 5 - 10 kg za pse > 10 - 20 kg za pse > 20 - 40 kg za pse > 40 - 60 kg
Tablet strength 3 mg/0.06 mg/ 12.5 mg
Jakost tablete 3 mg/0,06 mg/12,5 mg
Tablet strength 6 mg/0.12 mg/ 25 mg
Jakost tablete 6 mg/0,12 mg/25 mg
Tablet strength 3 mg/0.06 mg/12.5 mg
Jakost tablete 3 mg/0,06 m g/12,5 mg
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Vsaka tableta vsebuje:
Name and address of the manufacturer responsible for batch release
A. PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij Corden Pharma GmbH
BATCH NUMBER
KARTONSKA ŠKATLA
chewable tablet
FARMACEVTSKA OBLIKA žvečljiva tableta
Simparica Trio chewable tablets for dogs 1.25-2.5 kg Simparica Trio chewable tablets for dogs >2.5-5 kg Simparica Trio chewable tablets for dogs >5-10 kg Simparica Trio chewable tablets for dogs >10-20 kg Simparica Trio chewable tablets for dogs >20-40 kg Simparica Trio chewable tablets for dogs >40-60 kg sarolaner/moxidectin/pyrantel
Simparica Trio žvečljive tablete za pse 1,25 - 2,5 kg Simparica Trio žvečljive tablete za pse > 2,5 - 5 kg Simparica Trio žvečljive tablete za pse > 5 - 10 kg Simparica Trio žvečljive tablete za pse > 10 - 20 kg Simparica Trio žvečljive tablete za pse > 20 - 40 kg Simparica Trio žvečljive tablete za pse > 40 - 60 kg sarolaner/moksidektin/pirantel
Simparica Trio chewable tablets for dogs 1.25-2.5 kg Simparica Trio chewable tablets for dogs >2.5-5 kg Simparica Trio chewable tablets for dogs >5-10 kg Simparica Trio chewable tablets for dogs >10-20 kg Simparica Trio chewable tablets for dogs >20-40 kg Simparica Trio chewable tablets for dogs >40-60 kg
Simparica Trio žvečljive tablete za pse 1,25 - 2,5 kg Simparica Trio žvečljive tablete za pse > 2,5 - 5 kg Simparica Trio žvečljive tablete za pse > 5 - 10 kg Simparica Trio žvečljive tablete za pse > 10 - 20 kg Simparica Trio žvečljive tablete za pse > 20 - 40 kg Simparica Trio žvečljive tablete za pse > 40 - 60 kg
Wheat germ
Rp-Vet.
Dose
Odmerek
The European Commission issued a decision on 1 July 2010.
Evropska komisija je odločbo izdala dne 1. julija 2010.
2 Article 20 of Regulation (EC) No 726/2004.
2 Člen 20 Uredbe (ES) št. 726/2004.
Ref. EMEA/727399/2009 rev. EMEA/H/A-31/1097
EMEA/727399/2009 rev. EMEA/H/A-31/1097
London, 1 July 2010 Doc.
London, 1. julija 2010 Sklic dok.
Article 31 of Directive 2001/83/EC as amended, referral under Community interest.
Člen 31 Direktive 2001/83/ES, kakor je bila spremenjena, napotitev v interesu Skupnosti.
Most of these medicines are authorised nationally.
Večina teh zdravil je odobrenih v posameznih državah.
A communication containing the key messages of this review will be distributed to doctors at national level.
Obvestilo s ključnimi ugotovitvami tega pregleda bo posredovano zdravnikom na nacionalni ravni.
• These medicines should only be used in accordance with the updated prescribing information.
• Ta zdravila so namenjena samo za uporabo v skladu s posodobljenimi informacijami o predpisovanju.
It may affect several organs such as the liver, lungs and heart.
Prizadene lahko tudi druge organe, na primer jetra, pljuča in srce.
Patients receive an injection of the contrast agent just before or during the scan.
Bolniki prejmejo injekcijo kontrastnega sredstva tik pred ali med slikanjem.
This included information from preclinical and clinical studies, as well as information provided by the companies that make the medicines.
Ocenil je tudi informacije iz predkliničnih in kliničnih študij ter informacije, ki so jih predložile družbe, ki izdelujejo zdravila.
The review was carried out under ‘Article 31'1 and ‘Article 20'2 referrals.
Pregled je bil izveden v skladu z napotitvenim postopkom po členu 311 in členu 202.
• information on the cases of NSF reported for each agent.
• informacije o poročanih primerih NSF za posamezno kontrastno sredstvo.
The Committee also concluded that an additional factor that may contribute to the risk of NSF is the way these medicines are used (such as the dose, how often they are given and for how long).
Odbor je zaključil tudi, da je dodatni dejavnik, ki lahko prispeva k tveganju NSF, način uporabe teh zdravil (npr. odmerek, pogostost in trajanje dajanja).
At the same time, the European Commission requested the CHMP to carry out the same assessment for the centrally authorised agents.
Hkrati je Evropska komisija pozvala CHMP, naj izvede enako oceno za sredstva, odobrena po centraliziranem postopku.
Two of these products - OptiMARK (gadoversetamide) and Vasovist (gadofosveset) - have received a marketing authorisation that is valid throughout the European Union (EU).
Dve izmed teh zdravil - OptiMARK (gadoversetamid) in Vasovist (gadofosveset) - sta prejeli dovoljenje za promet, ki je veljavno v Evropski uniji (EU).
• a warning that the elderly may be at particular risk of NSF, because their kidneys are less able to remove gadolinium from the body;
• opozorilo, da so starejše osebe še posebej izpostavljene tveganju NSF, ker so njihove ledvice manj sposobne odstranjevati gadolinij iz telesa;
For medium- and low-risk agents the CHMP recommended that:
Za sredstva s srednjim in nizkim tveganjem je CHMP priporočil, da:
In December 2007, the Scientific Advisory Group (SAG) for Diagnostics of the CHMP was convened to discuss the approach of the PhVWP.
Decembra 2007 je bila sklicana znanstvena svetovalna skupina (SAG) za diagnostiko odbora CHMP, da bi razpravljala o pristopu PhVWP.
Questions and answers on the review of gadolinium-containing contrast agents
Vprašanja in odgovori v zvezi s pregledom kontrastnih sredstev, ki vsebujejo gadolinij
They contain gadolinium, a ‘rare earth' metal, which is used as a ‘contrast enhancer' to help make the inside of the body more visible on the scan.
Vsebujejo gadolinij, „redko zemeljsko“ kovino, ki se uporablja kot „ojačevalec kontrasta“ za izboljšanje vidnosti telesa pri slikanju.
• a statement that there is no evidence to support the initiation of haemodialysis (a blood clearance technique) to prevent or treat NSF in patients not already undergoing haemodialysis;
• izjavo, da ni dokazov v podporo iniciaciji hemodialize (tehnike čiščenja krvi) za preprečevanje ali zdravljenje NSF pri bolnikih, pri katerih se hemodializa še ne izvaja;
• Doctors should record in the patient's notes the type and dose of contrast agent used.
• Zdravniki morajo v bolnikovo kartoteko zabeležiti vrsto in odmerek uporabljenega kontrastnega sredstva.
An association between the use of gadolinium-containing contrast agents and NSF was first observed in January 2006, when cases of the disease were reported in Denmark and Austria in patients with kidney problems undergoing MRI scans.
Povezava med uporabo kontrastnih sredstev, ki vsebujejo gadolinij, in NSF je bila najprej opažena januarja 2006, ko so o primerih bolezni poročali na Danskem in v Avstriji pri bolnikih s težavami z ledvicami, pri katerih se izvede slikanje MRI.
In addition, the prescribing information of all gadolinium-containing contrast agents should include:
Poleg tega morajo informacije o predpisovanju vseh kontrastnih sredstev, ki vsebujejo gadolinij, vsebovati:
NSF is a rare disease that causes thickening of the skin and connective tissues in patients with severe kidney problems.
NSF je redka bolezen, ki povzroči odebelitev kože in veznih tkiv pri bolnikih s hudimi težavami z ledvicami.
Consequently, in November 2008 the Danish medicines regulatory agency asked the CHMP to carry out an assessment of the risk of NSF for the non-centrally authorised gadolinium-containing contrast agents, and to recommend measures that could be taken to reduce this risk.
Novembra 2008 je zato danska regulatorna agencija za zdravila pozvala CHMP, naj izvede oceno tveganja NSF pri kontrastnih sredstvih, ki vsebujejo gadolinij, ki niso bila odobrena po centraliziranem postopku, in priporoča ukrepe, ki lahko prispevajo k zmanjšanju tega tveganja.
Finally, the CHMP recommended that further studies should be carried out on the long-term retention of gadolinium in human tissues (such as bone) released from gadolinium-containing contrast agents.
Končno je CHMP priporočil, da se izvedejo nadaljnje študije v zvezi z dolgoročnim zadrževanjem gadolinija v človeških tkivih (npr. v kosteh); ta gadolinij se sprošča iz kontrastnih sredstev, ki vsebujejo gadolinij.
Gadolinium-containing contrast agents include nine different active substances: gadobenic acid, gadobutrol, gadodiamide, gadofosveset, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide and gadoxetic acid.
Kontrastna sredstva, ki vsebujejo gadolinij, so sestavljena iz devetih različnih zdravilnih učinkovin: gadobenska kislina, gadobutrol, gadodiamid, gadofosveset, gadopentetska kislina, gadoterna kislina, gadoteridol, gadoversetamid in gadoksetna kislina.
• as a precaution, breastfeeding should be discontinued for at least 24 hours after the patient has received a high-risk agent;
• je kot preventivni ukrep treba prekiniti dojenje za najmanj 24 ur po tem, ko je bolnica prejela sredstvo z visokim tveganjem;
Why were gadolinium-containing contrast agents reviewed?
Zakaj so bila kontrastna sredstva, ki vsebujejo gadolinij, pregledana?
During 2007, more cases of the disease were reported and the CHMP's Pharmacovigilance Working Party (PhVWP) held several discussions to establish how the risk of NSF could be reduced.
Leta 2007 so poročali o več primerih bolezni, delovna skupina za farmakovigilanco (PhVWP) odbora CHMP pa je imela različne razprave v zvezi s tem, kako bi bilo mogoče zmanjšati tveganje NSF.
The SAG also highlighted the need to harmonise the prescribing information regarding the use of these agents particularly in high-risk groups, such as pregnant and breast-feeding women, children, the elderly and patients undergoing liver transplant.
Skupina SAG je poudarila tudi potrebo po uskladitvi informacij o predpisovanju v zvezi z uporabo teh sredstev predvsem v skupini z visokim tveganjem, kot so noseče in doječe ženske, otroci, starejše osebe in bolniki, pri katerih se izvede presaditev jeter.
However, the CHMP recognised that within the high-risk group the risk of NSF with gadoversetamide and gadodiamide appears higher than with gadopentetic acid, based on physicochemical properties, studies in animals and the number of cases of NSF reported worldwide.
Vendar pa je CHMP ugotovil, da je v skupini z visokim tveganjem tveganje NSF pri uporabi gadoversetamida in gadodiamida večje kot pri gadopentetski kislini, pri čemer je upošteval fizikalno-kemijske lastnosti, študije pri živalih in število primerov NSF, o katerih so poročali po vsem svetu.
The European Medicines Agency has completed a review of the risk of nephrogenic systemic fibrosis (NSF) in patients receiving gadolinium-containing contrast agents.
Evropska agencija za zdravila je zaključila pregled tveganja za nefrogeno sistemsko fibrozo (NSF) pri bolnikih, ki prejemajo kontrastna sredstva, ki vsebujejo gadolinij.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP agreed with the SAG classification of gadolinium-containing contrast agents into high-, medium- and low-risk agents based on their risk of causing NSF.
CHMP se je na podlagi ocene trenutno razpoložljivih podatkov in znanstvenih razprav v okviru Odbora strinjal s predlogom skupine SAG za razvrstitev kontrastnih sredstev, ki vsebujejo gadolinij, na sredstva z visokim, srednjim in nizkim tveganjem glede na tveganje za pojav NSF.
The SAG agreed with the PhVWP that the risk of developing NSF depends on the type of gadolinium-containing contrast agent used, and advised that these agents should be categorised into three groups:
Skupna SAG se je strinjala s PhVWP, da je tveganje nastanka NSF odvisno od vrste uporabljenega kontrastnega sredstva, ki vsebuje gadolinij, in predlagala razvrstitev teh sredstev v tri skupine:
• Gadolinium-containing contrast agents remain suitable diagnostic agents for use in patients undergoing an MRI scan, but doctors should be aware of the associated risk of NSF especially in patients with kidney problems, and other high-risk groups.
• Kontrastna sredstva, ki vsebujejo gadolinij, ostanejo še naprej primerna diagnostična sredstva za uporabo pri bolnikih, pri katerih se izvede slikanje MRI, vendar se morajo zdravniki zavedati povezanih tveganj za NSF, zlasti pri bolnikih s težavami z ledvicami in drugih skupinah z visokim tveganjem.
Gadolinium-containing contrast agents are diagnostic agents used in patients undergoing a magnetic resonance imaging (MRI) scan.
Kontrastna sredstva, ki vsebujejo gadolinij, so diagnostična sredstva, ki se uporabljajo pri bolnikih, pri katerih se izvede magnetno resonančno slikanje (MRI).
• the decision to continue or suspend breastfeeding for at least 24 hours after a scan should be taken by the doctor and the mother;
• morata odločitev o tem, ali se dojenje nadaljuje ali prekine za najmanj 24 ur po slikanju, sprejeti zdravnik in mati;
To minimise the risk of NSF the Committee recommended a number of changes to the prescribing information of these medicines, depending on the risk classification of the agents.
Za zmanjšanje tveganja NSF je Odbor priporočil številne spremembe informacij o predpisovanju teh zdravil, pri čemer se upošteva razvrstitev teh sredstev glede na tveganje.
The CHMP has assessed all of the available information on the risks of NSF associated with the use of gadolinium-containing contrast agents, particularly those used in patients with kidney problems and patients receiving a liver transplant, in neonates and infants, the elderly and women who are pregnant or breastfeeding.
CHMP je ocenil vse razpoložljive informacije o tveganju NSF zaradi uporabe kontrastnih sredstev, ki vsebujejo gadolinij, zlasti tistih, ki se uporabljajo pri bolnikih s težavami z ledvicami in pri bolnikih, pri katerih se izvede presaditev jeter, pri novorojenčkih in dojenčkih, starejših osebah in ženskah, ki so noseče ali dojijo.
For high-risk gadolinium-containing contrast agents, the CHMP recommended that:
Za kontrastna sredstva, ki vsebujejo gadolinij, z visokim tveganjem je CHMP priporočil, da:
• warnings should be added to the prescribing information for their use in patients with severe kidney problems and patients receiving a liver transplant;
• se k informacijam o predpisovanju doda opozorilo glede njihove uporabe pri bolnikih s hudimi težavami z ledvicami in bolnikih, pri katerih se izvede presaditev jeter;
What are gadolinium-containing contrast agents?
Kaj so kontrastna sredstva, ki vsebujejo gadolinij?
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that a number of measures need to be introduced into the prescribing information for these medicines, to minimise the risk of NSF associated with their use.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da je treba k informacijam o predpisovanju teh zdravil dodati številne ukrepe za zmanjšanje tveganja NSF, povezanega z njihovo uporabo.
• they must not be used in patients with severe kidney problems, in patients around the time of liver transplantation, and in newborn babies less than four weeks of age, who are known to have immature kidneys;
• se ne smejo uporabljati pri bolnikih s hudimi težavami z ledvicami, pri bolnikih okoli trenutka presaditve jeter in pri novorojenčkih, mlajših od štirih tednov, za katere je znano, da imajo nerazvite ledvice;
The medicines are only used by MR specialists.
Zdravilo uporabljajo le strokovnjaki za magnetno resonanco (MR).
• low risk: gadoteric acid (Dotarem), gadoteridol (ProHance) and gadobutrol (Gadovist).
• nizko tveganje: gadoterna kislina (Dotarem), gadoteridol (ProHance) in gadobutrol (Gadovist).
• their dose should be restricted to the minimum recommended dose in patients with moderate kidney problems and infants up to one year of age, and there should be at least a period of seven days between scans;
• se njihov odmerek omeji na minimalni priporočljiv odmerek pri bolnikih z zmernimi težavami z ledvicami in dojenčkih, starih do enega leta, poleg tega morata biti slikanji v razmiku najmanj sedmih dni;
• their dose should be restricted to the minimum recommended dose in patients with severe kidney problems, patients around the time of liver transplantation and neonates and infants up to one year of age, and there should be at least a period of seven days between scans;
• se njihov odmerek omeji na minimalni priporočljiv odmerek pri bolnikih s hudimi težavami z ledvicami, bolnikih okoli trenutka presaditve jeter ter novorojenčkih in dojenčkih, starih do enega leta, poleg tega morata biti slikanji v razmiku najmanj sedmih dni;
• medium risk: gadofosveset (Vasovist), gadoxetic acid (Primovist) and gadobenic acid
• srednje tveganje: gadofosveset (Vasovist), gadoksetna kislina (Primovist) in gadobenska kislina (MultiHance);
• high risk: gadoversetamide (OptiMARK), gadodiamide (Omniscan) and gadopentetic acid
• visoko tveganje: gadoversetamid (OptiMARK), gadodiamid (Omniscan) in gadopentetska kislina (Magnevist, Magnegita in Gado-MRT-ratiopharm);
• all patients should be screened for kidney problems using laboratory tests before receiving these agents.
• je treba pred prejetjem teh sredstev pri vseh bolnikih z laboratorijskimi preiskavami izvesti presejanje, da se ugotovi, ali so pri njih morda prisotne težave z ledvicami.
• screening for kidney problems using laboratory tests is recommended for all patients before receiving these agents.
• je pred prejetjem teh sredstev priporočljivo presejanje vseh bolnikov, da se ugotovi, ali so pri njih morda prisotne težave z ledvicami.
Tilt your head back.
Nagnite glavo nazaj.
Use at the same time each day.
Zdravilo uporabljajte vsak dan ob istem času.
Date of first authorisation: 18 July 2014 Date of last renewal: 20 February 2019
Datum prve odobritve: 18. julij 2014 Datum zadnjega podaljšanja: 20. februar 2019
Wash your hands before you start.
Preden začnete, si umijte roke.