natgillin/translations-raw huggingface dataset:
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Bolniki z redko prirojeno intoleranco na galaktozo, popolnim pomanjkanjem laktaze ali motnjo absorpcije glukoze-galaktoze tega zdravila ne smejo jemati.
The study demonstrated that Nityr can be administered with or without food without affecting its bioavailability.
Pokazale so, da se zdravilo Nityr lahko jemlje s hrano ali brez nje, ne da bi to vplivalo na njegovo biološko uporabnost.
Do not breast-feed while taking this medicine, see section “Do not take Nityr”.
Med jemanjem tega zdravila ne smete dojiti, glejte poglavje »Ne jemljite zdravila Nityr«.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
Once the bottle is opened, the medicine can be stored for a period of 2 months, after which it must be discarded.
Po prvem odprtju plastenke se lahko zdravilo shranjuje dva meseca, potem pa ga je treba zavreči.
Other medicines and Nityr
Druga zdravila in zdravilo Nityr
Contact your doctor immediately for an eye examination.
Nemudoma obiščite zdravnika, da vam pregleda oči.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 tablets
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 60 tablet
Based on in vitro studies, nitisinone is not expected to inhibit CYP 1A2, 2C9, 2C19, 2D6, 2E1 or 3A4mediated metabolism.
Študije in vitro so pokazale, da nitizonon ne bi smel zavirati presnove, ki deluje preko encimov CYP 1A2, 2C9, 2C19, 2D6, 2E1 ali 3A4.
Pharmacotherapeutic group: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products, ATC code: A16AX04.
Farmakoterapevtska skupina: Druga zdravila za bolezni prebavil in presnove, razna zdravila za bolezni prebavil in presnove, oznaka ATC: A16A X04.
A food effect study has been conducted with Nityr.
Opravljene so bile študije učinka hrane na zdravilo Nityr.
Store in the original bottle to protect from light.
Shranjujte v originalni plastenki zaradi zaščite pred svetlobo.
In vitro studies using human liver microsomes and cDNA-expressed P450 enzymes have shown limited CYP 3A4-mediated metabolism.
Študije in vitro, pri katerih so uporabili človeške mikrosome jeter in s cDNA izražene encime P450, so pokazale omejeno presnovo preko encima CY P3A4.
All patients
Število bolnikov
Nityr blocks the breakdown of tyrosine and the harmful substances are not formed.
Zdravilo Nityr zaustavi razgraditev tirozina in prepreči nastanek škodljivih snovi.
What you need to know before you take Nityr
Kaj morate vedeti, preden boste vzeli zdravilo Nityr
Marketing Authorisation Holder Cycle Pharmaceuticals (Europe) Limited 70 Sir John Rogerson's Quay Dublin 2
Imetnik dovoljenja za promet z zdravilom Cycle Pharmaceuticals (Europe) Limited 70 Sir John Rogerson's Quay Dublin 2
Nitisinone did not show carcinogenic potential in a 26-week carcinogenicity study in transgenic mice (TgrasH2).
V 26-tedenski študiji kancerogenosti pri transgenskih miših (TgrasH2) nitizinon ni pokazal kancerogenega potenciala.
Tablets are not suitable for breaking to make up additional strengths.
Tablete niso primerne za delitev z namenom, da se dobi drugačna jakost.
Common eye related side effects (may affect more than 1 in 10 people) are inflammation in the eye (conjunctivitis), opacity and inflammation in the cornea (keratitis), sensitivity to light (photophobia) and eye pain.
Pogosti neželeni učinki, povezani z očmi, (pojavijo se lahko pri več kot 1 od 10 bolnikov), ki jih povzročijo višje ravni tirozina, so vnetje v očesu (konjunktivitis), motnjava in vnetje roženice (keratitis), občutljivost za svetlobo (fotofobija) in bolečine v očeh.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Študije o medsebojnem delovanju z drugimi zdravili niso bile izvedene.
If you forget to take Nityr
Če ste pozabili vzeti zdravilo Nityr
During the shelf life, the patient may store the bottle after first opening for a period of 2 months, after which the medicinal product must be discarded.
Med rokom uporabnosti lahko bolnik plastenko po prvem odprtju shranjuje dva meseca, potem pa mora zdravilo zavreči.
Nitisinone treatment leads to normalised porphyrin metabolism with normal erythrocyte porphobilinogen synthase activity and urine 5-aminolevulinate, decreased urinary excretion of succinylacetone, increased plasma tyrosine concentration and increased urinary excretion of phenolic acids.
Zdravljenje z nitizinonom omogoča, da se vzpostavi normala presnova porfirina z normalnim delovanjem eritrocitne porfobilinogen-sintaze in 5-aminolevulinatom v urinu, da se zmanjša izločanje sukcinilacetona z urinom, poveča koncentracija tirozina v plazmi in tudi odvajanje fenola z urinom.
By inhibiting the normal catabolism of tyrosine in patients with HT-1, nitisinone prevents the accumulation of the toxic intermediates maleylacetoacetate and fumarylacetoacetate.
Pri inhibiciji normalnega katabolizma tirozina pri bolnikih, ki imajo HT-1, nitizinon prepreči akumulacijo toksičnih intermediatov, kot sta maleilacetoacetat in fumarilacetoacetat.
INFORMATION IN BRAILLE Nityr 10 mg
PODATKI V BRAILLOVI PISAVI Nityr 10 mg
If you stop taking Nityr
Če ste prenehali jemati zdravilo Nityr
Eye-related adverse reactions, such as conjunctivitis, corneal opacity, keratitis, photophobia, and eye pain, related to elevated tyrosine levels are therefore common.
Neželeni učinki, povezani z očmi, kot so konjunktivitis, motnjava roženice, keratitis, fotofobija in bolečine v očeh, povezane s povečanimi ravnmi tirozina, so zato pogosti.
Nityr with food Nityr can be taken with or without food throughout your course of treatment.
Zdravilo Nityr skupaj s hrano Zdravilo Nityr se lahko ves čas zdravljenja jemlje s hrano ali brez nje.
Shelf life after first opening - 2 months Open date:
Rok uporabnosti po prvem odprtju: 2 meseca Datum odprtja:
White to beige, round (7 x 2.3 mm), flat tablets which may display light yellow to brown speckles, marked “10” on one side and “L” on the other side.
Bele do bež, okrogle (7 x 2,3 mm), ploščate tablete, posejane s svetlorumenimi do rjavimi pikami, z oznako „10“ na eni strani in oznako „L“ na drugi.
Nityr has minor influence on the ability to drive and use machines.
Zdravilo Nityr ima blag vpliv na sposobnost vožnje in upravljanja strojev.
Contains lactose
Vsebuje laktozo.
A pre- and postnatal development study in the mouse showed statistically significantly reduced pup survival and pup growth during the weaning period at dose levels 125- and 25-fold higher, respectively, then the maximum recommended human dose, with a trend toward a negative effect on pup survival starting from the dose of 5 mg/kg/day.
Študije o pre- in postnatalnem razvoju pri miših so pokazale statistično značilno zmanjšano preživetje mladičev, izpostavljenih 125-krat večjim odmerkom, in zmanjšanje rasti mladičev po odstavitvi pri 25-krat večjih odmerkih v primerjavi z največjim priporočenim odmerkom za človeka.
Treatment of adult and paediatric patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
Zdravljenje odraslih in pediatričnih bolnikov (vseh starosti) s potrjeno diagnozo dedne tirozinemije tipa 1 (HT-1 - »hereditary tyrosinemia type 1«), ki so hkrati na dieti z nizko vsebnostjo tirozina in fenilalanina.
The tablets are packaged in plastic square bottles with a tamper-evident child-resistant closure.
Tablete so pakirane v plastično, pravokotno plastenko, ki ima za otroke varno zaporko s pečatom proti nedovoljenemu odpiranju.
If you have taken more of this medicine than you should, contact your doctor or pharmacist as soon as possible.
Če ste vzeli večji odmerek zdravila Nityr, kot bi smeli Če ste vzeli prevelik odmerek tega zdravila, se čim prej posvetujte z zdravnikom ali farmacevtom.
HDPE 75 mL square bottles with a tamper-evident child-resistant closure of polypropylene (PP).
Pravokotna plastenka iz HDPE velikosti 75 ml z za otroke varno zaporko s pečatom proti nedovoljenemu odpiranju iz polipropilena (PP).
Fertility There are no data on nitisinone affecting fertility.
Podatkov o vplivu nitizinona na plodnost ni.
The active ingredient of Nityr is nitisinone.
Zdravilna učinkovina v zdravilu Nityr je nitizinon.
What Nityr looks like and contents of the pack
Izgled zdravila Nityr in vsebina pakiranja
Nitisinone is a competitive inhibitor of 4-hydroxyphenylpyruvate dioxygenase, an enzyme which precedes fumarylacetoacetate hydrolase in the tyrosine catabolic pathway.
Nitizinon je kompetitivni inhibitor encima 4-hidroksifenilpiruvat-dioksigenaze, ki v katabolni poti tirozina katalizira stopnjo pred fumarilacetoacetat-hidrolazo.
The biochemical defect in hereditary tyrosinemia type 1 (HT-1) is a deficiency of fumarylacetoacetate hydrolase, which is the final enzyme of the tyrosine catabolic pathway.
Biokemična motnja pri dedni tirozinemiji tipa 1 (HT-1) je pomanjkanje fumarilacetoacetat-hidrolaze, ki je končni encim v katabolni poti tirozina.
The recommended total daily dose is 1 mg/kg body administered orally weight.
Priporočeni celotni dnevni odmerek je 1 mg/kg telesne mase, ki se daje peroralno.
< 2 months > 2-6 months > 6 months
Starost pri pojavu simptomov 1 leto 2 leti < 2 meseca > 2-6 mesecev > 6 mesecev
- Each tablet contains 10 mg nitisinone.
Ena tableta vsebuje 10 mg nitizinona.
The tablets are white to beige, round, flat which may display light yellow to brown speckles marked with “L” on one side and “10” on the other side.
Tablete so bele do bež barve, okrogle, ploščate, posejane s svetlorumenimi do rjavimi pikami, z oznako „L“ na eni strani in oznako „10“ na drugi.
How to take Nityr
Kako jemati zdravilo Nityr
Breastfeeding (see sections 4.6 and 5.3).
Matere, ki jemljejo nitizinon, ne smejo dojiti (glejte poglavji 4.6 in 5.3).
Nityr contains lactose
Zdravilo Nityr vsebuje laktoza
Contents of the pack and other information
Shranjevanje zdravila Nityr Vsebina pakiranja in dodatne informacije
The recommended initial dose in the paediatric and adult population is 1 mg/kg body weight administered orally.
Priporočeni začetni odmerek za otroke in odrasle je 1 mg/kg telesne mase, ki se jemlje peroralno.
- The other ingredients are glycerol dibehenate, and lactose monohydrate (see section 2 under
Drugi sestavini zdravila sta glicerol dibehenat in laktoza (v obliki monohidrata) (glejte poglavje 2 „Zdravilo Nityr vsebuje laktozo“)
Conjunctivitis, corneal opacity, keratitis, photophobia, eye pain
Pogosti konjunktivitis, motnjava roženice, keratitis, fotofobija, bolečine v očeh
Do not take Nityr: - if you are allergic to nitisinone or any of the other ingredients of this medicine (listed in section - Do not breast-feed while taking this medicine, see section “Pregnancy and breast-feeding”.
Ne jemljite zdravila Nityr - če ste alergični na nitizinon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
≤ 2 months ≤ 6 months > 6 months Overall
Starost na začetku zdravljenja 2 leti 4 leta 6 let ≤ 2 meseca ≤ 6 mesecev > 6 mesecev celokupna
Other common side effects - Reduced number of platelets (thrombocytopenia) and white blood cells (leukopenia), shortage of certain white blood cells (granulocytopenia).
Drugi pogosti neželeni učinki - zmanjšano število trombocitov (trombocitopenija) in belih krvnih celic (levkopenija),
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nityr 10 mg tablets nitisinone oral use
IME ZDRAVILA IN POT(I) UPORABE Nityr 10 mg tablete nitizinon peroralna uporaba
NAME OF THE MEDICINAL PRODUCT Nityr 10 mg tablets nitisinone
IME ZDRAVILA Nityr 10 mg tablete nitizinon
If you have the impression that the medicine is not working properly, talk to your doctor.
Če menite, da je učinek zdravila premočan ali prešibak, se posvetujte z zdravnikom.
It is recommended that a slit-lamp examination of the eyes is performed before initiation of nitisinone treatment.
Pred začetkom zdravljenja z nitizinonom je priporočljivo opraviti pregled oči s špranjsko svetilko.
MedDRA system organ class
Organski sistem
How to store Nityr
Shranjevanje zdravila Nityr
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg nitisinone.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 10 mg nitizinona.
A more restricted tyrosine and phenylalanine diet should be implemented in case the plasma tyrosine level is above 500 micromol/l.
Če raven tirozina v plazmi presega 500 mikromolov/l, je treba z dieto še bolj zmanjšati vnos tirozina in fenilalanina.
PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
PODATKI, KI MORAJO BITI NAVEDENI NA STIČNIH OVOJNINAH NALEPKA NA VSEBNIKU
Talk to your doctor or pharmacist before taking Nityr.
Pred začetkom jemanja zdravila Nityr se posvetujte z zdravnikom ali farmacevtom, - če ste opazili, da imate rdeče oči ali katere koli druge znake učinka na oči.
NAME OF THE MEDICINAL PRODUCT Nityr 10 mg tablets
Nityr 10 mg tablete
What Nityr contains - The active substance is nitisinone.
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Nityr Učinkovina je nitizinon.
1 year 2 years
2 letih
What you need to know before you take Nityr 3.
Kaj je zdravilo Nityr in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Nityr Kako jemati zdravilo Nityr Možni neželeni učinki
Lactose monohydrate
Glicerol dibehenat Laktoza (v obliki monohidrata)
The new measures are:
Novi ukrepi so naslednji:
17 July 2018 EMA/498908/2018
17. julij 2018 EMA/498908/2018
In the European Union, HES solutions for infusion have been approved via national procedures and are available in the Member States under various trade names.
V Evropski uniji so bile raztopine HES za infundiranje odobrene prek nacionalnih postopkov in so v državah članicah na voljo pod različnimi trgovskimi imeni.
• Alternative therapeutic options are available for routine clinical practice and should be considered according to relevant clinical guidelines.
• Alternativne možnosti zdravljenja so na voljo za rutinsko klinično prakso in jih je treba obravnavati v skladu z ustreznimi kliničnimi smernicami.
The review of HES solutions for infusion was initiated on 17 October 2017 at the request of the Swedish Medical Products Agency, under Article 107i of Directive 2001/83/EC.
Pregled raztopin HES za infundiranje se je začel 17. oktobra 2017 na zahtevo švedske agencije za zdravila, v skladu s členom 107i Direktive 2001/83/ES
The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Skupina CMDh, organ, ki zastopa države članice EU, je odgovorna za zagotavljanje usklajenih varnostnih standardov za zdravila, odobrena po nacionalnih postopkih po vsej EU.
This programme will be implemented by the companies holding the marketing authorisations.
Omenjeni program bodo izvajale družbe, ki imajo dovoljenja za promet.
• Patients who have questions or concerns should speak to their treating doctor.
• Bolniki, ki imajo kakršna koli vprašanja ali pomisleke, naj se posvetujejo z lečečim zdravnikom.
• If you are given a HES infusion, your doctor will monitor your kidneys to check that they are working well enough.
• Če boste prejeli infuzijo HES, bo zdravnik spremljal vaše ledvice, da preveri, ali dovolj dobro delujejo.
• The expected benefit of treatment should be carefully weighed against the uncertainties with regard to long-term safety.
• Skrbno je treba pretehtati pričakovane koristi zdravljenja glede na negotovosti v zvezi z dolgoročno varnostjo.
Besides blood products, there are two types of medicines used for plasma volume replacement: crystalloids and colloids.
Poleg krvnih proizvodov obstajata dve vrsti zdravil, ki se uporabljata za nadomeščanje volumna plazme: kristaloidi in koloidi.
As the CMDh position was adopted by majority vote, it was sent to the European Commission.
Ker je skupina CMDh svoje stališče sprejela z večino glasov, je bilo to poslano Evropski komisiji.
They belong to the class of medicines known as colloids.
Sodijo v razred zdravil, znanih kot koloidi.
• Additional studies are ongoing with HES solutions in patients with trauma and those undergoing elective surgery to further investigate the long-term safety of HES prescribed according to the recommendations for use (dose less than 30 ml/kg and duration less than 24 hours).
• Izvajajo se dodatne študije o raztopinah HES pri bolnikih s travmo in tistih v postopku načrtovanih kirurških posegov, da se nadalje prouči dolgoročna varnost HES, predpisanih v skladu s priporočili za uporabo (odmerek je manj kot 30 ml/kg in čas je krajši od 24 ur).
Medicines to remain on the market provided that training, controlled access and warnings on the packaging are implemented
Zdravila ostajajo na trgu pod pogojem, da se izvajajo usposabljanja, nadzorovan dostop in opozorila na ovojnini
The review was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), EMA's Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations on 12 January 2018.
Pregled je najprej opravil Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC) agencije EMA, odgovoren za presojo varnostnih vprašanj o zdravilih za uporabo v humani medicini, in 12. januarja 2018 podal sklop priporočil.
Healthcare professionals will be informed in writing of the outcome of the review and the introduction of the new risk minimisation measures, which include the introduction of a controlled access programme requiring training of relevant healthcare professionals on the safe use of these medicines.
Zdravstveni delavci bodo pisno obveščeni o rezultatih pregleda in uvedbi novih ukrepov za zmanjšanje tveganja, vključno z uvedbo programa nadzorovanega dostopa, ki od ustreznih zdravstvenih delavcev zahteva usposabljanje o varni uporabi teh zdravil.
The CMDh agreed with the PRAC's assessment of the serious risks in critically ill patients and patients with sepsis.
Skupina CMDh se je strinjala z oceno odbora PRAC o resnih tveganjih pri kritično bolnih bolnikih in bolnikih s sepso.
Treatment should be guided by continuous haemodynamic monitoring so that the infusion is stopped as soon as haemodynamic goals have been achieved.
Zdravljenje je treba usmerjati z neprekinjenim hemodinamičnim spremljanjem, tako da se infuzija ustavi takoj, ko so doseženi hemodinamični cilji.
However, the CMDh gave further consideration to the place of HES in the clinical practice of some countries, noted that previous risk minimisation measures had some effect, and considered that a combination of new risk minimisation measures would effectively ensure that HES solutions are not used in patients at risk.
Vendar je skupina CMDh nadalje proučila položaj HES v klinični praksi nekaterih držav in ob upoštevanju dejstva, da so bili prejšnji ukrepi za zmanjšanje tveganja učinkoviti, menila, da bi kombinacija novih ukrepov za zmanjšanje tveganja učinkovito zagotovila, da se raztopine HES ne bodo uporabljale pri bolnikih s tveganjem.
After looking at these specific aspects, in May 2018 the PRAC confirmed its previous recommendation for suspension and sent a revised recommendation to the CMDh.
Potem ko je odbor PRAC proučil te posebne vidike, je maja 2018 potrdil svoje prejšnje priporočilo za začasni umik dovoljenja za promet z zdravilom in poslal revidirano priporočilo skupini CMDh.
• Use of HES solutions for infusion should be restricted to the initial phase of volume resuscitation with a maximum time interval of 24 hours.
• Uporabo raztopin HES za infundiranje je treba omejiti na začetno fazo nadomeščanja tekočin z najdaljšim časovnim intervalom 24 ur.
An increased need for renal replacement therapy has been reported up to 90 days after HES administration.
Kot so poročali, se povečana potreba po nadomestnem zdravljenju ledvične odpovedi kaže do 90 dni po prejemu odmerka HES.
The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a position on 24 January 2018.
Priporočila odbora PRAC so bila poslana usklajevalni skupini za postopek z medsebojnim priznavanjem in za decentralizirani postopek - v humani medicini (CMDh), ki je sprejela stališče 24. januarja 2018.
• writing directly to healthcare professionals to ensure that they are fully aware of the conditions of use of the medicines and the groups of patients that must not receive them due to an increased risk of kidney injury and death.
• neposredno pisno obveščanje zdravstvenih delavcev, s čimer se zagotovi, da so ti v celoti seznanjeni s pogoji uporabe zdravil in skupinami bolnikov, ki teh zdravil ne smejo prejeti zaradi povečanega tveganja okvare ledvic in smrti.
• the implementation of a controlled access programme by the companies holding the marketing authorisations to ensure that only accredited hospitals will be supplied with these medicines.
• izvajanje programa nadzorovanega dostopa s strani podjetij, ki imajo dovoljenja za promet, s čimer se zagotovi, da bodo zdravila prejele le odobrene bolnišnice.
The CMDh also requested marketing authorisation holders to conduct studies to check that only patients who should be treated with these medicines are receiving them.
Skupina CMDh je od imetnikov dovoljenja za promet zahtevala tudi izvedbo študij, s katerimi se prepričajo, da zdravila prejemajo samo bolniki, ki se morajo zdraviti z njimi.
This followed further reflection, in consultation with EU Member States, on whether it would be feasible to introduce new measures that would effectively reduce the risks with these medicines.
Do te odločitve so prišli po podrobni proučitvi in po posvetovanju z državami članicami EU, ali bi bilo mogoče uvesti nove ukrepe, s katerimi bi učinkovito zmanjšali tveganja, povezana s temi zdravili.
• HES solutions for infusion are also contraindicated in dehydrated patients, hyperhydrated patients, patients with intracranial or cerebral haemorrhage, burn injuries, severe hyperkalaemia, hypernatraemia, hyperchloraemia, congestive heart failure, organ transplant patients and patients with impaired hepatic function.
• Raztopine HES za infundiranje so prav tako kontraindicirane pri dehidriranih bolnikih, hiperhidriranih bolnikih, bolnikih z znotrajlobanjsko ali možgansko krvavitvijo, opeklinami, hudo hiperkaliemijo, hipernatriemijo, hiperkloremijo ali srčnim popuščanjem, bolnikih s presajenim organom in bolnikih z oslabljenim delovanjem jeter.
This is in addition to ongoing studies on the benefits and risks of HES solutions in patients with trauma and those undergoing elective surgery.
Te se izvajajo poleg tekočih študij o koristih in tveganjih raztopin HES pri bolnikih s travmo in tistih v postopku nenujnih operacij.
Hydroxyethyl starch solutions: CMDh introduces new measures to protect patients
Raztopine hidroksietilnega škroba: skupina CMDh uvaja nove ukrepe za zaščito bolnikov
Blood coagulation parameters should be monitored carefully in case of prolonged use.
V primeru podaljšane uporabe je treba skrbno spremljati parametre koagulacije krvi.
The accreditation would require that relevant healthcare professionals receive training on the safe use of HES solutions for infusion.
Za pridobitev odobritve bi morali ustrezni zdravstveni delavci opraviti usposabljanje o varni uporabi raztopin HES za infundiranje.
In April 2018, the European Commission requested that the PRAC and the CMDh further consider any possible unmet medical need that could result from a suspension, as well as the feasibility and likely effectiveness of additional risk minimisation measures.
Evropska komisija je aprila 2018 zahtevala, da odbor PRAC in skupina CMDh nadalje proučita morebitne neizpolnjene zdravstvene potrebe, ki bi lahko izhajale iz začasnega umika dovoljenja za promet z zdravilom, ter izvedljivost in verjetno učinkovitost dodatnih ukrepov za zmanjšanje tveganj.