natgillin/translations-raw huggingface dataset:
Pre-filled syringe 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Napolnjena injekcijska brizga 1 ml vsebuje 330,9 mg gadoversetamida, kar ustreza 500 mikromolom.
AUTHORISATION
uporaba
hardening of the skin which may affect also soft tissue and internal organs (nephrogenic systemic fibrosis), feeling unwell
zadebelitev kože, ki lahko vpliva tudi na mehka tviva in notranje organe
Dizziness,
Ušesne bolezni,
Keep the vial in the outer carton in order to protect from light.
Brizge shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Urticaria, Cold sweat, Erythema, Hyperhidrosis
Urtikarija, hladen pot, eritem,
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of Optimark and some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR <30ml/min/1.73m2) and/or acute kidney injury.
Pri bolnikih s hudo akutno ali kronično ledvično okvaro (GFR < 30 ml/min/1,73m2) in/ali akutno poškodbo ledvic so poročali o nefrogeni sistemski fibrozi (NSF), povezani z uporabo zdravila
Pack sizes:
100 bolnikov):
• Additional risk minimisation measures
• Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
Not all pack-sizes may be marketed.
10 x 30 ml Na trgu morda ni vseh navedenih pakiranj.
List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant(s) in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe zdravila, predlagateljev v državah članicah
Oral drop solution Oral use
100 microgram/ml peroralna raztopina Peroralna uporaba
This summary was last updated on 28 January 2013.
Povzetek je bil nazadnje posodobljen dne 28/01/2013.
If damaged a new intraruminal device should be used.
Če je poškodovan, je treba uporabiti nov intraruminalni sistem.
This improves energy production in the cow's body and reduces the level of ketones in the blood.
Tako izboljša proizvodnjo energije v kravjem telesu in zniža raven ketonov v krvi.
Continuous release means that monensin is released slowly from the device.
Kontinuirano sproščanje pomeni, da se monenzin iz sistema sprošča počasi.
Exposure to monensin may result in an allergic response in certain people.
Izpostavljenost monenzinu lahko pri nekaterih ljudeh izzove alergijsko reakcijo.
It attaches to the surface of bacterial cells and interferes with the mechanism for transporting nutrients.
Veže se na površino bakterijskih celic in ovira delovanje mehanizma za transport hranil.
Other information about Kexxtone:
Druge informacije o zdravilu Kexxtone:
Kexxtone must not be used in animals weighing less than 300 kg.
Zdravilo Kexxtone se ne sme uporabljati pri živalih s telesno maso manj kot 300 kg.
It is mainly active against Gram-positive bacteria.
V glavnem učinkuje na grampozitivne bakterije.
The cumulative ketosis rate was 11.5% in the Kexxtone group compared with 25.6% in the placebo group.
Kumulativna stopnja ketoze v skupini, ki je prejemala zdravilo Kexxtone, je bila 11,5 %, v primerjavi s 25,6 % v skupini s placebom.
The European Commission granted a marketing authorisation valid throughout the European Union, for Kexxtone on 28 January 2013.
Evropska komisija je dovoljenje za promet z zdravilom Kexxtone, veljavno po vsej Evropski uniji, odobrila dne 28/01/2013.
People who are known to be hypersensitive (allergic) to monensin or any of the ingredients should avoid contact with the product.
Ljudje z znano preobčutljivostjo (alergijo) na monenzin ali katero koli drugo sestavino zdravila naj se izogibajo stiku s sistemom.
Kexxtone has been studied in one main study involving 1,312 commercial dairy cows.
Zdravilo Kexxtone je bilo raziskano v eni glavni študiji, ki je vključevala 1 312 krav molznic za prodajo.
Dogs, horses, other equines or guinea fowl must not be allowed access to Kexxtone as consumption of intraruminal device contents can be fatal in these species.
Psi, konji, drugi kopitarji in pegatke ne smejo imeti dostopa do zdravila Kexxtone, saj lahko zaužitje vsebine intraruminalnega sistema pri teh živalskih vrstah povzroči smrt.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Kexxtone exceed the risks for the approved indication and recommended that Kexxtone be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je sklenil, da koristi zdravila Kexxtone presegajo z njim povezana tveganja pri odobreni indikaciji, in priporočil, da se zanj odobri dovoljenje za promet.
The main measure of effectiveness was the cumulative rate of clinical ketosis in the cows over the 15 to 16 weeks after calving.
Glavno merilo učinkovitosti je bila kumulativna stopnja klinične ketoze pri kravah v obdobju 15 do 16 tednov po telitvi.
Gloves should be removed and hands and exposed skin washed after handling the product.
Po rokovanju s sistemom je treba odstraniti rokavice in si umiti roke ter izpostavljeno kožo.
Clinical ketosis was defined based on a minimum level of the substance ß-hydroxybutyrate in the blood in combination with one or more clinical signs of ketosis.
Klinična ketoza je bila določena na podlagi najmanjše ravni ß-hidroksibutirata v krvi v kombinaciji z enim ali več kliničnimi znaki ketoze.
The person administering Kexxtone should wear gloves when handling the product, including when retrieving a regurgitated intraruminal device.
Oseba, ki daje zdravilo Kexxtone, mora pri rokovanju s sistemom nositi rokavice, tudi pri odstranjevanju regurgitiranega intraruminalnega sistema.
What benefit has Kexxtone shown during the studies?
Kakšne koristi je zdravilo Kexxtone izkazalo med študijami?
Accidental administration of more than one intraruminal device could result in side effects typical of monensin overdose, including decreased appetite, scouring (diarrhoea) and lethargy.
Nenamerna uporaba več kot enega intraruminalnega sistema lahko povzroči neželene učinke, ki so običajni za prevelik odmerek monenzina, vključno z zmanjšanjem apetita, drisko (diarejo) in letargijo.
People should not eat, drink or smoke while handling Kexxtone.
Med uporabo zdravila Kexxtone osebe ne smejo jesti, piti ali kaditi.
It is available as a continuous-release intraruminal device (a device administered through the animal's mouth and placed within the rumen, or first stomach, of cattle).
Na voljo je v obliki intraruminalnega sistema s kontinuiranim sproščanjem (sistem, ki se vstavi živali skozi usta in namesti v vamp oziroma prvi del želodca goveda).
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat or milk used for human consumption.
Karenca je obdobje, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in se lahko meso ali mleko uporabi za prehrano ljudi.
Ketosis is a metabolic disturbance in which blood glucose levels are low and substances called ketones (such as acetoacetatic acid and β-hydroxybutyrate) accumulate in the blood.
Ketoza je presnovna motnja, za katero je značilna nizka raven glukoze v krvi in kopičenje snovi, ki jih imenujemo ketoni (na primer acetoacetatna kislina in β-hidroksibutirat), v krvi.
A single intraruminal device is given to a dairy cow or heifer three to four weeks before the expected calving, using an appropriate administration tool.
Pri kravi molznici oziroma telici se tri do štiri tedne pred pričakovano telitvijo uporabi en intraruminalni sistem, ki se ga da z ustreznim orodjem za dajanje.
The active substance in Kexxtone, monensin, is an antibiotic produced by natural fermentation.
Zdravilna učinkovina v zdravilu Kexxtone, monenzin, je antibiotik, ki nastane z naravno fermentacijo.
Monensin changes the population of microbes in the rumen resulting in an increase of the bacteria that produce propionate, a substance used to make glucose.
Monenzin spremeni mikrobno populacijo v vampu, pri čemer se poveča število bakterij, ki proizvajajo propionat - snov, ki sodeluje pri tvorjenju glukoze.
A single dose of Kexxtone was compared with a placebo (dummy treatment) given three to four weeks before the expected calving date.
Enkratni odmerek zdravila Kexxtone so primerjali s placebom (zdravilom brez zdravilne učinkovine), ki so ga živalim dali tri do štiri tedne pred pričakovanim datumom telitve.
What is the risk associated with Kexxtone?
Kakšna tveganja so povezana z zdravilom Kexxtone?
Treated cattle should be held in a confined area for one hour after administration to observe for failure to swallow or regurgitation.
Zdravljeno govedo je treba eno uro po uporabi zdravila zadržati v zaprtem prostoru in opazovati, ali lahko požira oziroma ali pride do regurgitacije.
Kexxtone is used to reduce the incidence of ketosis in dairy cows and heifers which are expected to develop ketosis in the period around calving.
Zdravilo Kexxtone se uporablja za zmanjšanje pojavnosti ketoze pri kravah molznicah in telicah, pri katerih se pričakuje razvoj ketoze v obdobju pred in po telitvi.
Kexxtone is a veterinary medicine that contains the active substance monensin.
Kexxtone je zdravilo, ki vsebuje zdravilno učinkovino monenzin.
Why has Kexxtone been approved?
Zakaj je bilo zdravilo Kexxtone odobreno?
Cattle should be re-checked for up to four days after dosing in case the intraruminal device has not been fully swallowed and has lodged in the oesophagus (the gullet or tube leading from the mouth to the rumen).
Govedo je treba do štiri dni po odmerjanju pregledovati, saj se lahko zgodi, da žival intraruminalnega sistema ne požre v celoti in se ta zagozdi v požiralniku (oziroma cevi, ki povezuje usta in vamp).
If this occurs, the product should be re-administered if undamaged.
Če ne požira ali če regurgitira, je treba ponovno dati zdravilo, če sistem ni poškodovan.
How does Kexxtone work?
Kako zdravilo Kexxtone deluje?
What is Kexxtone used for?
Za kaj se zdravilo Kexxtone uporablja?
How has Kexxtone been studied?
Kako je bilo zdravilo Kexxtone raziskano?
What is Kexxtone?
Kaj je zdravilo Kexxtone?
The withdrawal period for Kexxtone for cattle is zero days for meat and milk.
Karenca za meso in mleko po uporabi zdravila Kexxtone je nič dni.
References: 1.
Referenčna literatura: 1.
More about the procedures
Več o postopkih
While the re-examination was ongoing, some Member States decided to suspend or limit the marketing or use of these medicines in their territories.
V času, ko je potekal ponoven pregled, so se nekatere države članice odločile, da bodo začasno ustavile ali omejile trženje oziroma uporabo teh zdravil na svojih ozemljih.
* The CMDh is a medicines regulatory body representing the European Union (EU) Member States
* CMDh je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU).
HES will be available in restricted patient populations
HES bo na voljo za omejene populacije bolnikov
For the re-examination procedure the PRAC confirmed its previous position.
Pri ponovnem pregledu mnenja je odbor PRAC potrdil svoje prvotno stališče.
These recommendations are based on a review of all available safety and efficacy data, including recent data4,5,6, from clinical studies, meta-analyses and post-marketing experience.
Ta priporočila temeljijo na pregledu vseh razpoložljivih podatkov o varnosti in učinkovitosti, vključno z najnovejšimi podatki4,5,6 iz kliničnih študij, metaanaliz in izkušenj v obdobju trženja.
• Patients who have any questions or concerns should speak to the treating doctor, pharmacist or nurse.
• Bolniki, ki imajo kakršna koli vprašanja ali pomisleke, naj se posvetujejo z lečečim zdravnikom, farmacevtom ali medicinsko sestro.
A review of HES solutions for infusion was initiated on 29 November 2012 at the request of the German medicines agency, under Article 31 of Directive 2001/83/EC.
Pregled raztopin za infundiranje, ki vsebujejo HES, se je začel dne 29. novembra 2012 na zahtevo nemške agencije za zdravila v skladu s členom 31 Direktive 2001/83/ES.
In accordance with EU legislation, this type of action required that an EU review procedure be carried out.
V skladu z zakonodajo EU je treba v takem primeru opraviti revizijski postopek na ravni EU.
This review procedure ran in parallel with the re-examination of the PRAC's June 2013 recommendation and both procedures were finalised on 10 October 2013.
Ta je potekal vzporedno s ponovnim pregledom mnenja, ki ga je odbor PRAC podal junija 2013, tako da sta se oba postopka zaključila 10. oktobra 2013.
This review, which had been carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), concluded on 13 June 2013, but some of the marketing authorisation holders requested a re-examination.
Pregled, ki ga je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC), se je zaključil 13. junija 2013, vendar so nekateri imetniki dovoljenja za promet z zdravilom zahtevali ponoven pregled.
Consequently, on 27 June 2013, the UK triggered an EU review of HES solutions under Article 107i of Directive 2001/83/EC.
Posledično je Združeno kraljestvo dne 27. junija 2013 sprožilo pregled raztopin, ki vsebujejo HES, na ravni EU v skladu s členom 107i Direktive 2001/83/ES.
The expected benefit of treatment should be carefully weighed against the uncertainties with regard to long-term safety, and other available treatment options should be considered.
Zato je treba skrbno pretehtati pričakovane koristi zdravljenja in negotovosti v zvezi z dolgoročno varnostjo ter razmisliti o drugih možnostih zdravljenja, ki so na voljo.
In the EU, HES-containing solutions for infusion have been approved via national procedures and are available in all Member States under various trade names.
Raztopine za infundiranje, ki vsebujejo HES, so bile v EU odobrene po nacionalnih postopkih in so pod različnimi trgovskimi imeni na voljo v vseh državah članicah.
Colloids contain large molecules such as starch, whereas crystalloids, such as saline (salt) solutions or Ringer's acetate, contain smaller molecules.
Koloidi vsebujejo velike molekule, kot je na primer škrob, medtem ko kristaloidi, kot so na primer raztopine soli ali Ringerjev acetat, vsebujejo manjše molekule.
• HES solutions should be used at the lowest effective dose for the shortest period of time.
• Raztopine, ki vsebujejo HES, je treba uporabljati pri najmanjšem učinkovitem odmerku za najkrajši možni čas.
As HES-containing solutions for infusion are all authorised nationally, the PRAC recommendations were forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Ker so vse raztopine za infundiranje, ki vsebujejo HES, odobrene na nacionalni ravni, so bila priporočila odbora PRAC posredovana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela dokončno stališče.
Healthcare professionals have been informed in writing of the outcome of the review and the changes to the use of HES solutions.
Zdravstveni delavci so bili pisno obveščeni o izidu tega pregleda in o spremembah v zvezi z uporabo raztopin, ki vsebujejo HES.
The use of HES must be discontinued at the first sign of renal injury.
Uporabo HES je treba prekiniti ob prvem znaku okvare ledvic.
There are two main types of medicines used for volume replacement: crystalloids and colloids.
Za nadomeščanje volumna se v glavnem uporabljata dve vrsti zdravil: kristaloidi in koloidi.
In addition to updating the product information, further studies should be carried out on the use of these medicines in elective surgery and trauma patients.
Poleg posodobitve informacij o zdravilu je treba opraviti tudi dodatne študije o uporabi teh zdravil pri načrtovanih kirurških posegih in bolnikih s poškodbami.
However, new evidence was considered in the parallel Article 107i procedure and this was the basis for the PRAC's final recommendation on the use of HES solutions.
V vzporednem postopku po členu 107i pa so bili upoštevani novi dokazi, na podlagi katerih je odbor PRAC podal končno priporočilo glede uporabe raztopin, ki vsebujejo HES.
In order to minimise potential risks in these patients, HES solutions should not be used for more than 24 hours and patients' kidney function should be monitored after HES administration.
Da bi zmanjšali možna tveganja pri teh bolnikih, se raztopine, ki vsebujejo HES, ne smejo uporabljati dlje kot 24 ur, po njihovem dajanju pa je treba pri bolnikih spremljati delovanje ledvic.
On 23 October 2013, the Coordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh)*, endorsed by majority the recommendations of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that HES solutions must no longer be used to treat patients with sepsis (bacterial infection in the blood) or burn injuries or critically ill patients because of an increased risk of kidney injury and mortality.
Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh)* je 23. oktobra 2013 z večino potrdila priporočila Odbora za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila, ki je zaključil, da se raztopine, ki vsebujejo HES, ne smejo več uporabljati za zdravljenje bolnikov s sepso (bakterijsko okužbo krvi) ali opeklinami in kritično bolnih, saj obstaja povečano tveganje za okvaro ledvic in smrt.
Available on: http://clinicaltrials.gov/ct2/show/NCT00318942 5.
Dostopno na: http://clinicaltrials.gov/ct2/show/NCT00318942
Basel Study for Evaluation of Starch (130;0.4) Infusion in Septic Patients:BaSES (130;0.4) Trial, listed at http://clinicaltrials.gov/show/NCT00273728
Basel Study for Evaluation of Starch (130;0.4) Infusion in Septic Patients:BaSES (130;0.4) Trial, navedeno na http://clinicaltrials.gov/show/NCT00273728
Available on ClinicalTrials.gov (NCT01122277) last updated on 07 July 2011: http://clinicaltrials.gov/ct2/show/NCT01122277?term=NCT01122277&rank=1
Dostopno na ClinicalTrials.gov (NCT01122277), nazadnje posodobljeno 7. julija 2011: http://clinicaltrials.gov/ct2/show/NCT01122277?term=NCT01122277&rank=1
Treatment should be guided by continuous haemodynamic monitoring so that the infusion is stopped as soon as appropriate haemodynamic goals have been achieved.
Pri zdravljenju je treba upoštevati rezultate stalnega hemodinamskega spremljanja, tako da se infundiranje prekine takoj, ko so dosežene ustrezne ciljne vrednosti hemodinamskih spremenljivk.
The review of HES solutions was carried out by the PRAC following the publication of studies showing an increased risk of mortality in patients with sepsis1,2 and an increased risk of kidney injury requiring dialysis in critically ill patients1,2,3 following treatment with HES solutions.
Odbor PRAC je pregled raztopin, ki vsebujejo HES, opravil po objavi študij, ki so pokazale, da se je po zdravljenju z raztopinami, ki vsebujejo HES, pri bolnikih s sepso1,2 povečalo tveganje za smrt, pri kritično bolnih1,2,3 pa tveganje za okvaro ledvic, ki zahteva zdravljenje z dializo.
As the CMDh position was adopted by majority vote, it was sent to the European Commission, which endorsed it and, on 19 December 2013, adopted a final legally binding decision valid throughout the European Union (EU).
Ker je skupina CMDh omenjeno stališče sprejela z večino, je bilo posredovano Evropski komisiji, ki ga je potrdila in dne 19. decembra 2013 sprejela končno pravno zavezujočo odločbo, ki velja za celotno Evropsko unijo (EU).
As the CMDh position was adopted by majority vote, it was sent sent to the European Commission, which endorsed it and adopted an EU-wide legally binding decision on 19 December 2013.
Ker je skupina CMDh stališče sprejela z večino glasov, je bilo posredovano Evropski komisiji, ki ga je potrdila in dne 19. decembra 2013 sprejela pravno zavezujočo odločbo, ki velja za celotno EU.
• HES solutions are contraindicated in severe coagulopathy.
• Raztopine, ki vsebujejo HES, so kontraindicirane pri hudi koagulopatiji.
An increased need for renal replacement therapy has been reported up to 90 days after HES administration.
V obdobju do 90 dni po dajanju HES so poročali o povečani potrebi po nadomestnem zdravljenju ledvične odpovedi.
Infusion solutions containing HES are frequently used for volume replacement and belong to the class known as colloids.
Raztopine za infundiranje, ki vsebujejo HES, se pogosto uporabljajo za nadomeščanje volumna in spadajo v skupino zdravil, imenovanih koloidi.
• There is a lack of robust long-term safety data in patients undergoing surgical procedures and in patients with trauma.
• Zanesljivih podatkov o dolgoročni varnosti pri bolnikih z načrtovanim kirurškim posegom in bolnikih s poškodbami je zelo malo.
HES solutions may continue to be used in patients to treat hypovolaemia (low blood volume) caused by acute (sudden) blood loss, where treatment with alternative infusions solutions known as ‘crystalloids' alone are not considered to be sufficient.
Raztopine, ki vsebujejo HES, se lahko še naprej uporabljajo za zdravljenje bolnikov s hipovolemijo (zmanjšanim volumnom krvi) zaradi akutne (nenadne) izgube krvi, kadar samo zdravljenje z drugimi raztopinami za infundiranje, ki jim pravimo kristaloidi, ne zadošča.
• HES solutions may continue to be used to treat hypovolaemia (low blood volume) caused by acute (sudden) blood loss.
• Raztopine, ki vsebujejo HES, se lahko še naprej uporabljajo za zdravljenje hipovolemije (zmanjšanega volumna krvi) zaradi akutne (nenadne) izgube krvi.
Blood coagulation parameters should be monitored carefully in case of repeated administration.
Pri večkratnem dajanju HES je treba skrbno spremljati parametre strjevanja krvi.
However, the doctor should monitor the patient's kidney function after HES administration.
Vendar pa mora zdravnik po dajanju HES spremljati delovanje ledvic bolnika.
• HES solutions should only be used for the treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient.
• Raztopine, ki vsebujejo HES, se lahko uporabljajo samo za zdravljenje hipovolemije zaradi akutne izgube krvi, kadar sami kristaloidi ne zadoščajo.
Additional studies will be performed with HES solutions in patients with trauma and in elective surgery.
Raztopine, ki vsebujejo HES, bodo pri bolnikih s poškodbami in pri načrtovanih kirurških posegih raziskali v dodatnih študijah.
• HES solutions are now contraindicated in patients with renal impairment or renal replacement therapy.
• Raztopine, ki vsebujejo HES, so po novem kontraindicirane pri bolnikih z okvaro ledvic in bolnikih, ki potrebujejo nadomestno zdravljenje ledvične odpovedi.
• Because of the risk of kidney injury and mortality, HES solutions must no longer be used in patients with sepsis (bacterial infection in the blood) or burn injuries or critically ill patients.
• Raztopine, ki vsebujejo HES, se zaradi tveganja za okvaro ledvic in smrt ne smejo več uporabljati pri bolnikih s sepso (bakterijsko okužbo krvi) ali opeklinami in pri kritično bolnih.
• Because of the risk of kidney injury and mortality, HES solutions must no longer be used in patients with sepsis, burn injuries or critically ill patients.
• Raztopine, ki vsebujejo HES, se zaradi tveganja za okvaro ledvic in smrt ne smejo več uporabljati pri bolnikih s sepso ali opeklinami in pri kritično bolnih.
HES solutions should be discontinued at the first sign of coagulopathy.
Ob prvem znaku koagulopatije je treba uporabo raztopin, ki vsebujejo HES, prekiniti.
Patients' kidney function should be monitored after HES administration.
Po dajanju HES je treba spremljati delovanje ledvic bolnikov.
Oral use sachet , , , , , , , , , , (Paper/LDPE/alu/ n n n LDPE)
Peroralna uporaba vrečka (papir/LDPE/alu/LDPE)
Gastro-resistant v granules
Gastrorezistentna zrnca
Pack size
30 vrečk
Name
Jakost
The European Commission granted a marketing authorisation valid throughout the European Union for Evicel on 6 October 2008.
Evropska komisija je dovoljenje za promet z zdravilom Evicel, veljavno po vsej Evropski uniji, odobrila dne 6. oktobra 2008.