natgillin/translations-raw huggingface dataset:
As a consequence, the CHMP has recommended the maintenance of the Marketing Authorisations for the medicinal products referred to in Annex I for which the amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet are set out in Annex III and in accordance to the conditions set out in Annex IV.
Posledično je CHMP priporočil ohranitev dovoljenj za promet z zdravili iz Dodatka I, katerih dopolnila zadevnih poglavij povzetkov glavnih značilnosti zdravila in navodila za uporabo so navedena v Dodatku III in v skladu s pogoji iz Dodatka IV.
There is no evidence that supports the use of haemodialysis for preventing or treating NSF in patients not already undergoing haemodialysis, but this may be useful at removing GdCAs in patients already on haemodialysis.
Ni dokazov za podporo uporabe hemodialize za preprečevanje ali zdravljenje NSF pri bolnikih, ki še ne prejemajo hemodialize, vendar utegne biti to koristno pri odstranjevanju GdCA pri bolnikih, pri katerih se hemodializa že izvaja.
DE - Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Nemčija ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
High risk: a) Linear non-ionic chelates including gadoversetamide (OptiMARK) and gadodiamide (Omniscan).
Visoko tveganje: a) Linearni neionski helati, vključno z gadoversetamidom (OptiMARK) in gadodiamidom (Omniscan).
The use of high risk GdCAs is contraindicated in patients with severe renal impairment.
Uporaba GdCA z visokim tveganjem je kontraindicirana pri bolnikih s hudo okvaro ledvic.
[If use is not authorised for infants below the age of 1 year a statement in section 4.4 is not necessary.
[Če se zdravilo ne odobri za dojenčke, mlajše od 1 leta, izjava v poglavju 4.4 ni obvezna.
NSF is a disease involving thickening of the skin and connective tissues.
NSF je bolezen pri kateri so koža in mehka tkiva zadebeljeni.
DE - Germany be imaging GmbH Dr.-Rudolf-Eberle-Str. 8-10 D-76534 Baden-Baden Germany
Nemčija be imaging GmbH Dr.-Rudolf-Eberle-Str. 8-10 D-76534 Baden-Baden Germany
Therefore and considering the overall benefit/risk, the CHMP agreed that for all patients to be administered with high NSF-risk GdCAs mandatory screening by laboratory tests should be performed.
Ob upoštevanju tega in celokupnega razmerja med koristmi in tveganji se je CHMP strinjal, da je treba pri vseh bolnikih, ki bodo prejeli GdCA z visokim tveganjem, izvesti obvezno presejanje z laboratorijskimi testi.
In addition to the minimisation measures included in the product information, the CHMP having considered the evidence that toxic free gadolinium ions are retained in human tissues concluded that studies evaluating the potential for long-term retention of gadolinium in bone are needed.
CHMP je po proučitvi ukrepov za zmanjševanje tveganj, ki so vključeni v informacijah o zdravilu, in dokazov o zadrževanju strupenih prostih gadolinijevih ionov v človeških tkivih zaključil, da so potrebne študije, ki bi obravnavale možnost dolgoročnega zadrževanja gadolinija v kosteh.
The GdCAs are available for different types of MR scan varying from product to product, including liver, brain and whole body scan.
GdCA so na voljo za različne vrste magnetnoresonančnega slikanja, odvisno od zdravila, vključno s slikanjem jeter, možganov in celotnega telesa.
Strong warnings are included for medium and low NSF risk GdCAs as regards use in this particular special population.
GdCA s srednje visokim in nizkim tveganjem NSF so priložena stroga opozorila glede uporabe pri tej posebni populaciji.
All GdCAs are chelate complexes containing Gd3+, the highly toxic gadolinium ion, which potentially may be released through transmetallation in vivo.
Vsi GdCA so helatni kompleksi, ki vsebujejo Gd3+, zelo strupen gadolinijev ion, ki se utegne sproščati s transmetilacijo in vivo.
GdCAs have been associated with nephrogenic systemic fibrosis (NSF), a rare, serious and lifethreatening syndrome involving fibrosis of the skin, joints and internal organs in patients with severe renal impairment.
GdCA so povezani z nefrogeno sistemsko fibrozo (NSF), tj. redkim, resnim in smrtno nevarnim sindromom, ki vključuje fibrozo kože, sklepov in notranjih organov pri bolnikih s hudo okvaro ledvic.
However, screening should only require laboratory testing following evaluation of the patient's medical history and the minimisation measure should be the same for all GdCAs.
Za presejanje zadošča že laboratorijski test po oceni bolnikove zdravstvene anamneze, ukrep za zmanjševanje tveganja pa mora biti enak pri vseh GdCA.
There are no data from the use of {active substance} in pregnant women.
Ni zadostnih podatkov o uporabi {zdravilne učinkovine} pri nosečnicah.
Other Minimisation Measures
Drugi ukrepi za zmanjševanje tveganja
Co-factors that may increase the risk of NSF such as serum calcium and phosphate levels at the time of administration of a GdCA should be studied and biomarkers evaluated.
Treba je proučiti druge dejavnike, ki utegnejo povečati tveganje NSF, kot so ravni kalcija in fosfatov v serumu v trenutku dajanja GdCA, ter oceniti biološke označevalce.
No dose adjustments are recommended but screening of 65 years and older patients for renal dysfunction is of particular importance prior to the administration of GdCAs.
Ni priporočil glede prilagoditve odmerka, vendar je presejanje bolnikov, starih 65 let in več, glede ledvične disfunkcije pred dajanjem GdCA zelo pomembno.
Use during pregnancy is not recommended for any GdCA due to the possibility of gadolinium accumulation in human tissues.
Uporaba GdCA med nosečnostjo zaradi možnosti akumulacije gadolinija v človeških tkivih ni priporočljiva.
Patients undergoing liver transplantation are at particular risk of NSF if exposed to GdCAs particularly to the high-risk GdCAs.
Pri bolnikih, pri katerih se izvede presaditev jeter, je prisotno posebno veliko tveganje NSF, če so izpostavljeni GdCA, zlasti GdCA z visokim tveganjem.
Your doctor will discuss whether you should continue breast-feeding or interrupt breast-feeding for a period of 24 hours after you receive {Invented name}.
Zdravnik bo presodil, ali lahko nadaljujete z dojenjem oziroma morate prekiniti z dojenjem za 24 ur po prejemu zdravila {lastniško ime}.
Available data in animals have shown excretion of {active substance} in milk (for details see section 5.3).
Razpoložljivi podatki pri živalih kažejo na izločanje {zdravilne učinkovine} v mleko (za podrobnosti glejte pogalvje 5.3).
Macrocyclic chelates including gadoteric acid (Dotarem), gadoteridol (ProHance) and gadobutrol (Gadovist).
Makrociklični helati, vključno z gadotersko kislino (Dotarem), gadoteridolom (ProHance) in gadobutrolom (Gadovist).
For all other GdCAs the continuation or suspension of breast feeding is left to the discretion of the mother in consultation with the doctor.
Pri vseh drugih GdCA o nadaljevanju ali prekinitvi dojenja odloči mati po posvetu z zdravnikom.
{Invented name} can be removed by haemodialysis.
Zdravilo {izmišljeno ime} se lahko odstrani s hemodializo.
Therefore, the MAHs are requested to submit to the CHMP protocols and timelines for the studies of gadolinium accumulation in human bone within 3 months of the decision on this referral procedure.
Imetniki dovoljenj za promet z zdravilom morajo zato CHMP predložiti protokole in roke za študije akumulacije gadolinija v človeških kosteh v 3 mesecih po odločbi o tem postopku napotitve.
Your doctor may decide to take a blood test to check how well your kidneys are working before making the decision to use {Invented name}, especially if you are 65 years of age or older.
Vaš zdravnik bo morda pred odločitvijo o uporabi zdravila {lastniško ime} naročil preiskavo krvi, s katero bo preveril delovanje vaših ledvic, zlasti če ste stari 65 let ali več.
There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.
Ni dokazov, ki bi podprli uvedbo hemodialize za preprečevanje ali zdravljenje NSF pri bolnikih, ki se ne zdravijo s hemodializo.
Screening for renal dysfunction
Presejanje glede ledvične disfunkcije
Use during pregnancy and lactation
Uporaba med nosečnostjo in dojenjem
Haemodialysis shortly after {Invented name} administration may be useful at removing {Invented name} from the body.
Hemodializa neposredno po uporabi zdravila {izmišljeno ime} je morda koristna za odstranjevanje zdravila {izmišljeno ime} iz telesa.
{Invented name} is contraindicated in neonates up to 4 weeks of age (see section 4.3).
Zdravilo {Lastniško ime} je kontraindicirano pri novorojenčkih do četrtega tedna starosti (glejte poglavje 4.3).
Pregnancy [Amend currently approved text for data in pregnant women and animal studies in line with the CHMP Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: From Data to Labelling (24 July 2008)]
Nosečnost [Dopolniti trenutno odobreno besedilo s podatki o nosečnicah in študijah na živalih skladno z dokumentom CHMP Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: From Data to Labelling (24. julij 2008)]
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na razmnoževanje (glejte poglavje 5.3).
The MAHs should provide to the CHMP an annual cumulative review on nephrogenic systemic fibrosis (NSF) cases commencing one year after Commission Decision and for 3 consecutive years.
Imetniki dovoljenj za promet z zdravilom morajo CHMP predložiti letni kumulativni varnostni pregled primerov nefrogene sistemske fibroze (NSF) tri zaporedna leta, pri čemer morajo prvi pregled predložiti eno leto po odločbi Komisije.
The MAHs should submit to the CHMP protocols and timelines for studies evaluating the potential for long-term accumulation of gadolinium in human bone.
Imetniki dovoljenja za promet z zdravilom morajo Odboru CHMP predložiti protokole in roke za študije o oceni možnosti za dolgoročno akumulacijo gadolinija v človeških kosteh.
Neonates, infants, children and adolescents [If use is permitted in neonates and infants add a statement on use in neonates and infants]
Novorojenčki, dojenčki in mladostniki [Če se dovoli uporaba pri novorojenčkih in dojenčkih, se doda izjava o uporabi pri novorojenčkih in dojenčkih]
The use of medium and low risk GdCAs in neonates should only be considered after careful consideration subject to dose and interval administration restrictions.
Uporaba GdCA s srednje visokim in nizkim tveganjem pri novorojenčkih je mogoča šele po skrbnem premisleku ob upoštevanju omejitev odmerka in intervala dajanja.
It is not necessary to adjust your dose if you are 65 years of age or older but you will have a blood test to check how well your kidneys are working.
Prilagajanje odmerkov ni potrebno, če ste stari 65 let in več, vendar pa vam bodo naredili krvne preiskave za oceno delovanja ledvic.
[Use currently approved text with the addition of information on NSF]
[Uporabi se trenutno odobreno besedilo z dodatkom informacije o NSF]
Linear ionic chelates including gadofosveset (Vasovist), gadoxetic acid (Primovist) and gadobenic acid (MultiHance).
Linearni ionski helati, vključno z gadofosvesetom (Vasovist), gadoksetno kislino (Primovist) in gadobensko kislino (MultiHance).
If use of {Invented name} cannot be avoided, the dose should not exceed {x} mmol/kg body weight.
Če se uporabi zdravila {izmišljeno ime} ni mogoče izogniti, odmerek ne sme preseči {x} mmol/kg telesne mase.
As the renal clearance of {active substance} may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.
Ker je lahko pri starostnikih ledvični očistek {zdravilne učinkovine} zmanjšan, je še posebej pomembno, da se pri bolnikih, starejših od 65 let, preveri delovanje ledvic.
If it is necessary to use {Invented name}, the dose should not exceed {x} mmol/kg body weight.
Če se zdravilo {izmišljeno ime} mora uporabiti, odmerek ne sme preseči {x} mmol/kg telesne mase.
UK - United Kingdom
Velika Britanija
Because of the lack of information on repeated administration, {Invented name} injections should not be repeated unless the interval between injections is at least 7 days.
Zaradi pomanjkanja podatkov o večkratni uporabi se odmerjanja zdravila {izmišljeno ime} ne sme ponavljati, razen če je presledek med injekcijama vsaj 7 dni.
The MAH supported the CHMP proposed risk minimisation for all patients to be screened for renal dysfunction irrespectively of the GdCAs.
Imetnik dovoljenja za promet z zdravilom je podprl ukrepe za zmanjševanje tveganja, ki jih je predlagal CHMP, za vse bolnike, pri katerih se bo izvajalo presejanje glede ledvične disfunkcije ne glede na GdCA.
This information is reflected in all GdCAs' product information.
Te informacije so vključene v podatkih o vseh GdCA.
Use for whole body MRI is not recommended in children less than 6 months of age.
Uporaba MRS celotnega telesa ni priporočljiva pri otrocih, mlajših od 6 mesecev.
{Invented name} should not be used in newborn babies up to the age of 4 weeks and is not recommended in children under 2 years.
Zdravilo {Lastniško ime} se ne sme uporabljati pri novorojenčkih do četrtega tedna starosti in se ne priporoča za uporabo pri otrocih, mlajših od dveh let.
Liver transplant patients
Bolniki s presaditvijo jeter
Therefore {Invented name} must not be used in patients with severe renal impairment, in patients in the perioperative liver transplantation period and in neonates (see section 4.3).
Zdravila {Lastniško ime} se ne sme uporabljati pri bolnikih s hudo okvaro ledvic, pri bolnikih v perioperativnem obdobju presaditve jeter in pri novorojenčkih (glejte poglavje 4.3).
Therefore {Invented name} must not be used in patients with severe renal impairment, in patients in the perioperative liver transplantation period.
Zdravila {Lastniško ime} se ne sme uporabljati pri bolnikih s hudo okvaro ledvic in pri bolnikih v perioperativnem obdobju presaditve jeter.
Lactation [Amend currently approved text for data in lactating women and animal studies in line with the CHMP Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: From Data to Labelling (24 July 2008)]
Dojenje [odobreno besedilo je treba dopolniti s podatki pridobljenimi v študijah na živalih v skladu s CHMP Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: From Data to Labelling (24 July 2008)]
On 19 November 2008, the European Commission triggered the corresponding procedure under Article 20 of Council Regulation (EC) 726/2004, for GdCAs which are centrally authorised (gadoversetamide and gadofosveset).
Uredbe Sveta (ES) št. 726/2004 za GdCA, ki sta centralno odobrena (gadoversetamid in gadofosveset).
Strong warnings are included in the GdCAs of medium and low NSF risk as regards use in patients with severe renal impairment but subject to dose restriction to a minimum during a scan and with a minimum 7 day interval between administrations.
GdCA s srednje visokim in nizkim tveganjem NSF so priložena stroga opozorila glede uporabe pri bolnikih s hudo okvaro ledvic, pri čemer je odmerek omejen na najmanjši odmerek med slikanjem, interval med odmerki pa mora znašati najmanj 7 dni.
Due to the immature renal function of infants below 1 year of age the use of all GdCAs should be subject to careful consideration and to dose and interval administration restrictions to not more than one injection of the minimum dose during a scan with a minimum 7 day interval between dose administrations.
Zaradi nezrelega delovanja ledvic pri dojenčkih, mlajših od 1 leta starosti, je treba o uporabi vseh GdCA odločiti po skrbnem premisleku ter ob upoštevanju omejitev odmerka in intervala dajanja, pri čemer je odmerek omejen na največ eno injekcijo najmanjšega odmerka med slikanjem, interval med odmerki pa mora znašati najmanj 7 dni.
It is unknown whether {active substance} is excreted in human milk.
Ni znano, ali se {zdravilna učinkovina} izloča v materino mleko.
Renally impaired patients and haemodialysis
Bolniki z okvaro ledvic in hemodializa
Whereas
ali
However, if use is necessary then dose restrictions to a minimum dose during one scan with a minimum 7 day interval between administrations are recommended.
Če je uporaba nujna, mora biti odmerek omejen na najmanjši odmerek med enim slikanjem, priporočen interval med odmerki pa znaša najmanj 7 dni.
{Invented name} should only be used after careful risk/benefit evaluation in patients with moderate renal impairment (GFR 30-59 ml/min/1.73m2) at a dose not exceeding {x} mmol/kg body weight (see section 4.4).
Zdravilo {Lastniško ime} se lahko uporablja le po skrbni presoji koristi in tveganj pri bolnikih z zmerno okvaro ledvic (GFR 30 - 59 ml/min/1,73 m2) v odmerkih, ki ne presegajo {x} mmol/kg telesne mase (glejte poglavje 4.4).
More than one dose should not be used during a scan.
Med slikanjem se lahko uporabi le en odmerek.
For patients with moderate renal impairment, since the risk is unknown for the high risk category of GdCAs it was agreed that use should only be considered after careful consideration of the benefit-risk, subject to dose restriction to not more than one injection of the minimum dose during a scan with a minimum 7 day interval between administrations.
Ker je tveganje pri kategoriji GdCA z visokim tveganjem neznano, je bilo za bolnike z zmerno okvaro ledvic dogovorjeno, da je uporaba dopustna le po skrbni proučitvi razmerja med koristmi in tveganji, pri čemer je odmerek omejen na največ eno injekcijo najmanjšega odmerka med slikanjem, interval med odmerki pa mora znašati najmanj 7 dni.
Animal studies have shown reproductive toxicity at repeated high doses (see section 5.3).
Študije na živalih so pokazale toksične učinke na sposobnost razmnoževanja pri večkratnih velikih odmerkih (glejte poglavje 5.3).
It is not necessary to adjust your dose if you are 65 years of age or older but you may have a blood test to check how well your kidneys are working.
Če ste stari 65 let ali več, vašega odmerka ne bo potrebno prilagajati, vendar boste morda morali opraviti krvno preiskavo, s katero se preverja delovanje vaših ledvic.
Before you receive {Invented name}, you will need to have a blood test to check how well your kidneys are working.
Pred uporabo zdravila {Lastniško ime} morajo biti opravljene krvne preiskave za oceno delovanja vaših ledvic.
The peel-off tracking label on the {vials/syringes/bottles} should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used.
Nalepko za sledljivost na {vialah/brizgah/steklenicah} prilepite na bolnikovo kartoteko, da je uporabljeno kontrastno sredstvo z gadolinijem natančno zabeleženo.
EE - Estonia
Estonija
Use of {Invented name} is not recommended in children less than 2 years of age.
Uporaba zdravila {izmišljeno ime} ni priporočljiva pri otrocih, mlajših od 2 let.
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.
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.
There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs).
Poročali so o nefrogeni sistemski fibrozi (ki povzroči otrdelost kože in lahko prizadene mehka tkiva ter notranje organe).
Prior to administration of {Invented name}, it is recommended that all patients are screened for renal dysfunction by obtaining laboratory tests.
Pred uporabo zdravila {izmišljeno ime} je priporočljivo pri vseh bolnikih preveriti delovanje ledvic z laboratorijskimi preiskavami.
Dosage in special patient groups [Use currently approved text with the addition of information on impaired renal function, use in neonates and infants and use in the elderly]
Odmerjanje pri posebnih skupinah bolnikov [Uporabi se trenutno odobreno besedilo z dodatkom informacije o okvarjenem delovanju ledvic, uporabi pri novorojenčkih, dojenčkih in starostnikih]
HOW TO USE {Invented name}
KAKO UPORABLJATI ZDRAVILO {lastniško ime}
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.
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.
[If use is not authorised in children under 2 years add the following statement]
[če uporaba ni odobrena pri otrocih, mlajših od dveh let, je treba dodati naslednje besedilo]
Tell your doctor if you are breast-feeding or about to start breast-feeding.
Obvestite zdravnika, če dojite ali boste kmalu začeli dojiti.
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.
Uporaba zdravila {lastniško ime} ni priporočljiva pri bolnikih s hudimi težavami z ledvicami in bolnikih po nedavni presaditvi ali pred presaditvijo jeter.
287 mg/ml (0,5 mmol/ml) solution for injection intravenous use
287 mg/ml (0,5 mmol/ml) Raztopina za injiciranje
Neonates up to 4 weeks of age, infants up to 1 year of age and children
Novorojenčki do 4 tednov starosti, dojenčki do 1 leta starosti in otroci
{Invented name} should not be used during pregnancy unless the clinical condition of the woman requires use of {active substance}.
Zdravila {izmišljeno ime} se ne sme uporabljati med nosečnostjo, razen če je zaradi kliničnega stanja nosečnice uporaba{zdravilne učinkovine}potrebna.
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.
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.
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.
Novorojenčki in dojenčki lahko prejmejo le en odmerek zdravila {lastniško ime} med slikanjem, nato pa mora do naslednjega slikanja miniti vsaj 7 dni.
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.
Zdravila {Lastniško ime} ne smete prejeti, če imate hudo okvaro ledvic ali če ste pred kratkim imeli ali v kratkem pričakujete presaditev jeter.
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).
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).
Neonates up to 4 weeks of age and infants up to 1 year of age
Novorojenčki do 4. tedna starosti in dojenčki do 1 leta starosti
solution for injection syringe intravenous use
Raztopina za injiciranje (syringe) Intravenska uporaba
If use is authorised in neonates and infants add the following statement]
Če se zdravilo odobri za novorojenčke in dojenčke, se doda naslednja izjava]