natgillin/translations-raw huggingface dataset:
− The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD). 
− Zdravilo se lahko uporablja kot del strategije zdravljenja za nadzor alergijskega dermatitisa, ki ga povzročajo bolhe (flea allergy dermatitis - FAD).
After a single administration of 5 times the maximum recommended dose to this sensitive dog breed, transient ataxia and/or muscle fasciculation were observed. 
Po enkratnem dajanju 5-krat večjega odmerka od največjega priporočenega odmerka zdravila, so se pri teh občutljivih pasmah psov pojavili prehodna ataksija in/ali mišične fascikulacije.
The tablets are packaged in aluminium foil/foil blisters packaged into an outer carton box. 
Tablete so pakirane v aluminijaste folija/folija pretisne omote pakirane v zunanjo kartonsko škatlo.
Therefore, during treatment with the veterinary medicinal product, other products that can inhibit pglycoprotein (e.g. cyclosporine, ketoconazole, spinosad, verapamil) should only be used concomitantly according to the benefit-risk assessment of the responsible veterinarian. 
Zato je treba med zdravljenjem z zdravilom za uporabo v veterinarski medicini sočasno uporabljati druga zdravila, ki lahko zavirajo p-glikoprotein (npr. ciklosporin, ketokonazol, spinosad, verapamil) le v skladu z oceno razmerja korist/tveganje odgovornega veterinarja.
If based on veterinarian opinion re-administration(s) of the product is required, any subsequent administration(s) must follow the minimum 1-month interval schedule. 
Če je na podlagi veterinarskega mnenja potrebna ponovna uporaba zdravila, mora vsaki naslednji uporabi slediti najmanj 1-mesečni razmik.
Pharmacotherapeutic group: antiparasitic products, moxidectin combinations. 
Farmakoterapevtska skupina: antiparazitiki, moksidektin, kombinacije.
In endemic areas, dogs should receive lungworm and/or heartworm preventive treatments at monthly intervals. 
Na endemičnih območjih morajo psi v mesečnih intervalih prejemati preventivna zdravljenja proti pljučni in/ali srčni glistavosti.
A single administration also prevents lungworm disease (by reducing the immature adults (L5) of A. vasorum) and heartworm disease (D. immitis) for one month. 
Enkratni odmerek zdravila preprečuje tudi bolezen pljučne glistavosti (z zmanjševanjem nezrelih odraslih nematod (L5) A. vasorum) in bolezen srčne gliste (D. immitis) za en mesec.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician. 
V primeru nenamernega zaužitja, se takoj posvetujete z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
Only negative animals should be treated. 
Zdraviti je treba le živali, ki so bile po testiranju negativne.
Following receptor binding, the channel opens to allow the influx of cations resulting in a depolarization and excitatory effects on nematode muscle, ultimately leading to spastic paralysis of the worm and death. 
Po vezavi na receptorje se kanal odpre, da omogoči dotok kationov, kar povzroči depolarizacijo in ekscitatorne učinke na mišici nematodov, kar vodi do spastične paralize črva in smrti.
No adverse reactions were observed in 8-weeks old healthy puppies administered with up to 5 times the maximum recommended dose for 7 consecutive monthly administrations. 
Nobenih neželenih učinkov niso opazili pri pasjih mladičih 8 tednov starih, zdravljenih z do 5-krat večjim odmerkom od največjega priporočenega odmerka, pri dajanju 7 mesecev zapored.
The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for 5 weeks; 
Zdravilo za uporabo v veterinarski medicini ima takojšen in trajen učinek ubijanja bolh nove infestacije vsaj 5 tednov;
For fleas, the onset of efficacy is within 12 to 24 hours of attachment for five weeks after product administration. 
Pri bolhah začne zdravilo učinkovati v času od 12 do 24 ur po pritrditvi, v obdobju pet tednov po dajanju zdravila.
Ticks on the animal prior to administration or from new infestations after product administration are killed within 48 hours. 
Klopi, ki so že na živali pred dajanjem zdravila ali po ponovni infestaciji po dajanju zdravila, so ubiti v 48 urah.
− For the prevention of angiostrongylosis by reducing the level of infection with immature adult 
− Za preprečevanje angiostrongiloze z zmanjševanjem stopnje okužbe z nezrelimi odraslimi (L5)
In a laboratory study, the product was well tolerated in dogs with a deficient multidrug-resistanceprotein 1 (MDR1 -/-) following single oral administration at 3 times the recommended dose. 
V laboratorijski študiji so psi z nezadostnim MDR1 -/- (multidrug-resistance-protein 1) zdravilo po dajanju enkratnega peroralnega odmerka, ki je bil 3-krat večji od priporočenega odmerka zdravila dobro prenašali.
A single treatment is efficacious for the treatment of gastrointestinal nematodes. 
Enkratno zdravljenje je učinkovito za zdravljenje okužb z gastrointestinalnimi nematodi.
Sarolaner does not interact with known insecticidal binding sites of nicotinic or other GABAergic insecticides such as neonicotinoids, fiproles, milbemycins, avermectins, and cyclodienes. 
Sarolaner ne deluje medsebojno z znanimi mesti vezave nikotinskih in drugih GABA-ergičnih insekticidov kot so neonikotinoidi, fiproli, milbemicini, avermektini in ciklodieni.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and blister after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in pretisnem omotu po {EXP}.
The veterinary medicinal product should be administered at a dose of 1.2-2.4 mg/kg of sarolaner, 0.024-0.048 mg/kg of moxidectin and 5-10 mg/kg of pyrantel in accordance with the following table: 
Zdravilo je treba dajati v odmerku 1,2 - 2,4 mg/kg sarolanerja, 0,024 - 0,048 mg/kg moksidektina in 5 - 10 mg/kg pirantela v skladu z naslednjo preglednico:
Sarolaner is active against adult fleas (Ctenocephalides felis and Ctenocephalides canis) as well as several tick species such as Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus. 
Sarolaner deluje na odrasle bolhe (Ctenocephalides felis in Ctenocephalides canis) kot tudi na številne vrste klopov kot so Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus in Rhipicephalus sanguineus.
The blister pack should then be returned into the carton immediately after use and the carton should be stored out of the sight and reach of children. 
Preostali pretisni omot je treba takoj po dajanju vrniti v škatlo, škatlo pa shranjevati nedosegljivo otrokom.
This interference leads to the opening of the chloride channels on the postsynaptic junction to allow the inflow of chloride ions. 
Ta motnja vodi do odprtja kloridnih kanalov na postsinaptičnem stiku, kar poveča prepustnost za kloridne ione.
Prevention of heartworm disease and angiostrongylosis: 
Preprečevanje bolezni srčne glistavosti in angiostrongiloze:
After treatment of the nematode infections, further flea and tick treatment should be continued with a mono-active product. 
Po zdravljenju okužb z nematodi je treba nadaljevati zdravljenje okužb z bolhami in klopi z zdravilom z eno učinkovino.
Its principal mode of action is interfering with neuromuscular transmission at the level of the glutamate-gated chloride channels and, to a lesser extent, of GABA (gamma amino butyric acid)-gated channels. 
Njegov glavni način delovanja je motenje živčno-mišičnega prenosa na ravni glutamat- odvisnih kloridnih kanalov in, v manjši meri, GABA (gama- aminomaslene kisline) odvisnih kanalov.
− For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis). 
− Za zdravljenje infestacij z bolhami (Ctenocephalides felis in Ctenocephalides canis).
Each tablet contains: 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje:
Sarolaner is slowly eliminated from plasma (half-life of approximately 12 days) via biliary excretion and elimination through the faeces with minor contributions of metabolic clearance. 
Sarolaner se počasi izloča iz plazme (razpolovna doba je približno 12 dni) z žolčem in blatom z manjšimi prispevki metaboličnega očistka.
The veterinary medicinal product can be used as part of the seasonal treatment of fleas and ticks (replacing treatment with a mono-active flea and tick product) in dogs with diagnosed concurrent gastrointestinal nematode infections. 
Zdravilo za uporabo v veterinarski medicini se lahko uporablja pri sezonskem zdravljenju bolh in klopov (zamenjava zdravljenja z zdravilom z eno učinkovino proti bolham in klopom) pri psih, ki imajo hkrati diagnosticirano okužbo z gastrointestinalnimi nematodi.
Sarolaner is readily and rapidly absorbed systemically following oral dosing, reaching maximum concentrations in plasma within 3.5 hours (tmax) after administration with a high bioavailability of 86.7%. 
Sarolaner se po peroralnem odmerjanju enostavno in hitro sistemsko absorbira in v 3,5 urah (tmax) po dajanju doseže največje koncentracije v plazmi z visoko biološko uporabnostjo 86,7 %.
The veterinary medicinal product also provides concurrent efficacy for the prevention of heartworm disease and angiostrongylosis. 
Zdravilo za uporabo v veterinarski medicini je hkrati tudi učinkovito pri preprečevanju obolenja srčne glistavosti in angiostrongiloze.
Moxidectin is readily and rapidly absorbed systemically following oral dosing, reaching maximum concentrations in plasma within 2.4 hours (tmax) after administration and with 66.9% bioavailability. 
Moksidektin se po peroralnem odmerjanju enostavno in hitro sistemsko absorbira in v 2,4 urah (tmax) po dajanju doseže največje koncentracije v plazmi z biološko uporabnostjo 66,9 %.
Pyrantel is active against immature stages (L5) and adults of Toxocara canis, adults of Ancylostoma caninum, Toxascaris leonina and Uncinaria stenocephala. 
Pirantel je učinkovit proti nezrelim stopnjam (L5) in odraslim nematodom Toxocara canis, odraslim Ancylostoma caninum, Toxascaris leonina in Uncinaria stenocephala.
Pyrantel mimics the agonist effects of ACh through high affinity binding to subtype specific ionophoric nAChRs in nematodes, while not binding at muscarinic mAChRs. 
Pirantel posnema agonistične učinke ACh z visoko afiniteto vezave na specifične podvrste ionofornih receptorjev nAChRs pri nematodih, vendar se ne veže na muskarinske receptorje mAChR.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in dogs intended for breeding. 
Varnost zdravila v obdobju brejosti in laktacije oziroma pri psih za vzrejo ni bila ugotovljena.
The product was well tolerated in dogs with a deficient multidrug-resistance-protein 1 (MDR1 -/-). 
Psi z nezadostnim MDR1 -/- (multidrug-resistance-protein 1) so zdravilo dobro prenašali.
Simparica Trio tablets are palatable and readily consumed by the majority of dogs when offered by the owner. 
Tablete Simparica Trio so okusne zato jih psi radi sprejmejo od lastnika.
Sarolaner binding to these receptors prevents the uptake of chloride ions by GABA and glutamate gated ion channels, thus resulting in increased nerve stimulation and death of the target parasite. 
Sarolaner, ki je vezan na te receptorje, preprečuje prehod kloridnih ionov preko GABA in glutamat odvisnih ionskih kanalov, kar se kaže v povečani živčni stimulaciji in smrti ciljnih parazitov.
The product should only be used in dogs when treatment of ticks / fleas and gastrointestinal nematodes is indicated at the same time. 
Zdravilo se sme uporabljati samo pri psih, kadar je hkrati indicirano zdravljenje klopov/bolh in gastrointestinalnih nematodov.
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.
Ectoparasites 
Ektoparaziti
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;