natgillin/translations-raw huggingface dataset:
1000 IU: one vial (glass type I) of powder + one vial (glass type I) of 10 ml solvent with stoppers (bromobutyl). 
1000 i.e.: ena viala (steklo tipa I) praška + ena viala (steklo tipa I) 10 ml vehikla z zaporkama (bromobutil).
Manufacturing also include steps in the processing of the blood or plasma that can inactivate or remove viruses. 
Izdelava v postopku obdelave krvi ali plazme vključuje tudi postopke, ki lahko onemogočijo delovanje virusov ali slednje odstranijo.
Contains: sodium chloride, histidine and sucrose. 
Vsebuje: natrijev klorid, histidin in saharozo
There are insufficient data to recommend the use of Nonafact in children less than 6 years of age. 
Ni zadostnih podatkov, da bi lahko priporočili uporabo zdravila Nonafact pri otrocih, mlajših od 6 let.
The powder should be dissolved in the supplied amount of water for injections. 
Prašek raztopite v priloženi količini vode za injekcije.
On demand treatment 
Zdravljenje na zahtevo
MARKETING AUTHORISATION NUMBER(S) EU/1/01/186/001 EU/1/01/186/002 13. 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/186/001
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains nominally 500 IU or 1000 IU of human coagulation factor IX. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje nazivno 500 i.e. ali 1.000 i.e. humanega koagulacijskega faktorja IX.
It is strongly recommended that every time that Nonafact is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product. 
Zelo priporočljivo je, da se pri dajanju zdravila Nonafact bolnikom vedno zabeleži ime in številka serije zdravila, s čimer se ohrani povezava med posameznim bolnikom in serijo uporabljenega zdravila.
Therefore, factor IX should be used by pregnant or breast-feeding women only if clearly indicated. 
Zato naj faktor IX noseče in doječe ženske uporabljajo le, kadar je to očitno potrebno.
Anaphylactic reaction 
Anafilaktična reakcija
500 IU: one vial (glass type I) of powder + one vial (glass type I) of 5 ml solvent with stoppers (bromobutyl). 
500 i.e.: ena viala (steklo tipa I) praška + ena viala (steklo tipa I) 5 ml vehikla z zaporkama (bromobutil).
After repeated treatment with human coagulation factor IX products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing. 
Po večkratnem zdravljenju z izdelki humanega koagulacijskega faktorja IX moramo bolnike spremljati glede razvoja nevtralizirajočih protiteles (inhibitorjev), ki jih količinsko določimo z Bethesda enotami (BE) z uporabo ustreznega biološkega testiranja.
It is strongly recommended that every time you receive a dose of Nonafact the name and batch number of the product are recorded in order to maintain a record of the batches used. 
Zelo priporočljivo je, da ob vsakemu prejetju odmerka zdravila Nonafact zabeležite ime in številko serije zdravila, da se s tem ohrani zapis uporabljenih serij.
Reconstitute with 10 ml of water for injections. 
Rekonstituirajte z 10 ml vode za injekcije.
If you forget to use Nonafact 
Če ste pozabili vzeti zdravilo Nonafact
For long-term prophylaxis against bleeding in patients with severe haemophilia B, the usual doses are 20 to 40 IU of factor IX per kilogram of body weight at intervals of 3 to 4 days. 
Za dolgoročno preprečevanje krvavitev pri bolnikih s hudo hemofilijo B so običajni odmerki od 20 i.e. do 40 i.e. faktorja IX na kilogram telesne mase v intervalih od 3 do 4 dni.
UNIQUE IDENTIFIER - 2D BARCODE 18. 
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
Remove from the refrigerator and allow the two vials to reach room temperature (15°C - 25°C). 
Viali vzemite iz hladilnika in počakajte, da dosežeta sobno temperaturo (od 15 °C do 25 °C).
Nonafact can be administered to prevent and treat bleeding in patients suffering from haemophilia B (a congenital lack of active factor IX). 
Zdravilo Nonafact lahko dajemo za preprečevanje in zdravljenje krvavitve pri bolnikih s hemofilijo B (prirojenim pomanjkanjem aktivnega faktorja IX).
• A vial of Nonafact containing 500 IU or 1000 IU of factor IX 
• vialo zdravila Nonafact, ki vsebuje 500 i.e. ali 1000 i.e. faktorja IX
PHARMACEUTICAL FORM Powder and solvent for solution for injection. 
FARMACEVTSKA OBLIKA Prašek in vehikel za raztopino za injiciranje.
If you have existing cardiovascular risk factors, substitution therapy with Factor IX may increase the cardiovascular risk. 
Če so pri vas prisotni obstoječi dejavniki tveganja za srčno-žilne dogodke, lahko nadomestno zdravljenje s faktorjem IX poveča tveganje za srčno-žilne dogodke.
For long-term prevention of bleeding in individuals with severe haemophilia B, the usual doses of 20 to 40 IU of factor IX per kilogram body weight should be given at intervals of 3 to 4 days. 
Za dolgoročno preprečevanje krvavitev pri posameznikih s hudo hemofilijo B je treba dajati običajne odmerke 20 i.e. do 40 i.e. faktorja IX na kilogram telesne mase v intervalih 3 do 4 dni.
There is a potential risk that higher doses of Nonafact will cause clots to form in blood vessels, resulting in thrombosis. 
Obstaja morebitno tveganje, da višji odmerki zdravila Nonafact povzročijo tvorbo krvnih strdkov v žilah, kar povzroči trombozo.
Single dose administration only. 
Samo za dajanje enkratnega odmerka.
If, after administration, you develop hypersensitive reactions like hives, itching and rash, chest tightness, wheezing and light headedness contact your physician immediately. 
Če se po dajanju pojavijo preobčutljivostne reakcije, kot so koprivnica, srbenje in izpuščaj, tiščoč občutek v prsnem košu, piskajoče in sopihajoče dihanje in omotičnost, nemudoma pokličite svojega zdravnika.
Life threatening bleeding 
Življenjsko nevarne krvavitve
Individuals with haemophilia B who receive factor IX preparations, should be monitored for the development of neutralising antibodies against factor IX (inhibitors) (see Possible side effects). 
Posameznike s hemofilijo B, ki prejemajo zdravila s faktorjem IX, je treba spremljati zaradi morebitnega razvoja nevtralizirajočih protiteles proti faktorju IX (inhibitorjev) (glej poglavje Možni neželeni učinki).
Nonafact contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'. 
Zdravilo Nonafact vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni »brez natrija«.
What Nonafact contains - The active substance is human coagulation factor IX. 
Kaj vsebuje zdravilo Nonafact: - Zdravilna učinkovina je humani koagulacijski faktor IX.
1000 IU human coagulation factor IX (100 IU/ml after reconstitution). 
1000 i.e. humanega koagulacijskega faktorja IX (100 i.e./ml po rekonstituciji).
During the course of treatment it is advised that the concentrations of factor IX in your blood are checked regularly. 
Med zdravljenjem svetujemo redno spremljanje koncentracije faktorja IX v vaši krvi.
Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX. 
Bolniki s hemofilijo B lahko razvijejo nevtralizirajoča protitelesa (inhibitorje) proti faktorju IX.
Solvent: water for injections 
Vehikel: voda za injekcije
There is a very slight risk that Nonafact will cause clots to form in blood vessels, resulting in thrombosis. 
Obstaja zelo majhno tveganje, da bo zdravilo Nonafact povzročilo tvorbo krvnih strdkov v krvnih žilah, kar bi povzročilo trombozo.
By reporting side effects you can help provide more information on the safety of this medicine. 
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V.* S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
No interactions of human coagulation factor IX products with other medicinal products have been reported. 
Ni znanih medsebojnih interakcij med izdelki s humanim koagulacijskim faktorjem IX in drugimi zdravili.
500 IU human coagulation factor IX (100 IU/ml after reconstitution). 
500 i.e. humanega koagulacijskega faktorja IX (100 i.e./ml po rekonstituciji).
Do not use solutions that are cloudy or have deposits. 
Ne uporabljajte motnih raztopin ali raztopin z usedlinami.
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). 
Zdravljenje in preprečevanje krvavitev in njihovih posledic pri bolnikih s hemofilijo B (prirojeno pomanjkanje faktorja IX).
Tilt the product vial when transferring the solvent to allow the solvent to flow down the side of the vial. 
Ko prelivate vehikel, vialo z zdravilom nagnite, da omogočite tok vehikla ob steni viale navzdol.
ATC code: B02BD04. 
Farmakoterapevtska skupina: antihemoragiki, koagulacijski faktor IX, oznaka ATC: B02BD04.
• If you get any side effects, talk to your doctor, pharmacist or nurse. 
• Če opazite kateri koli stranski učinek, se posvetujte s zdravnikom, farmacevtom ali medicinsko sestro.
How to use Nonafact 
Kako uporabljati zdravilo Nonafact
BOX VIAL OF POWDER 500 IU BOX VIAL OF POWDER 1000 IU 
ŠKATLA Z VIALO PRAŠKA 500 i.e. ŠKATLA Z VIALO PRAŠKA 1000 i.e.
Keep the vials in the outer carton, in order to protect from light. 
Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX. 
Upoštevati moramo tudi, da imajo lahko bolniki z inhibitorji faktorja IX povišano tveganje za anafilakso ob kasnejši izpostavitvi faktorju IX.
Cardiovascular events 
Srčno-žilni dogodki
What Nonafact looks like and contents of the pack 
Izgled zdravila Nonafact in vsebina pakiranja:
Nonafact 100 IU/ml powder and solvent for solution for injection Human coagulation factor IX 
Nonafact 100 i.e./ml prašek in vehikel za raztopino za injiciranje humani koagulacijski faktor IX
Reconstituted products should be inspected visually for particulate matter and discoloration prior to administration. 
Rekonstituirana zdravila je treba pred dajanjem vizualno pregledati, da ne vsebujejo neraztopljenih trdnih delcev in da niso obarvana.
No symptoms of overdose with human coagulation factor IX have been reported. 
O simptomih prevelikega odmerjanja humanega koagulacijskega faktorja IX niso poročali.
Your doctor will consider whether administration of Nonafact imposes a risk for coagulation complications. 
Vaš zdravnik bo presodil, ali dajanje zdravila Nonafact predstavlja tveganje za zaplete pri strjevanju krvi.
In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk. 
Pri bolnikih z obstoječimi dejavniki tveganja za srčno-žilne dogodke lahko nadomestno zdravljenje s faktorjem IX poveča tveganje za srčno-žilne dogodke.
Nonafact contains approximately 500 or 1000 IU (100 IU/ml) of human coagulation factor IX after reconstitution. 
Zdravilo Nonafact po rekonstituciji vsebuje približno 500 ali 1.000 i.e. (100 i.e./ml) humanega koagulacijskega faktorja IX.
Excipient(s) with known effect: 
Pomožna(e) snov(i) z znanim učinkom: natrijev klorid
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU (100 IU/ml after reconstitution) 1000 IU (100 IU/ml after reconstitution) 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 500 i.e. (100 i.e./ml po pripravi).
4.9 Overdose No symptoms of overdose with human coagulation factor IX have been reported. 
4.9 Preveliko odmerjanje O simptomih prevelikega odmerjanja humanega koagulacijskega faktorja IX niso poročali.
More extensive bleeding in joints, muscle bleeding or haematoma 
Bolj obsežna krvavitev v sklepih, krvavitev v mišico ali hematom
Nonafact contains trace amounts (< 0.1 ng mouse IgG/IU of factor IX) of the murine monoclonal antibody used in its purification. 
Zdravilo Nonafact vsebuje mišja monoklonska protitelesa v sledovih (< 0,1 ng mišjega IgG/i.e.
Early signs of bleeding in joints, muscle bleeding or oral bleeding 
Zgodnji znaki krvavitve v sklepih, krvavitev v mišico ali krvavitev v ustni votlini
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. 
Z mikrobiološkega vidika je treba zdravilo uporabiti takoj po rekonstituciji.Če ga ne uporabite takoj, je za čase skladiščenja med uporabo in pogoje pred uporabo odgovoren uporabnik.
See your doctor immediately, if bleeding does not stop as expected. 
Če se krvavitev ne ustavi, kot ste pričakovali, nemudoma obiščite svojega zdravnika.
Contact your doctor immediately if you suspect that the product is becoming progressively less effective. 
Če sumite, da postaja zdravilo čedalje manj učinkovito, nemudoma pokličite svojega zdravnika.
For reconstitution of Nonafact. 
Za rekonstitucijo zdravila Nonafact.
Nephrotic syndrome has been reported following attempted immune tolerance induction on haemophilia B patients with factor IX inhibitors and a history of allergic reaction. 
Po poskusu indukcije imunske tolerance pri bolnikih s hemofilijo B z inhibitorji faktorja IX in z alergijskimi reakcijami v preteklosti so poročali o nefrotskem sindromu.
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. 
Kljub vsem tem ukrepom pa možnosti prenosa okužbe na bolnika pri uporabi takih zdravil, pripravljenih iz človeške krvi ali plazme, ne moremo povsem izključiti.
There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations. 
Po dajanju zdravil s faktorjem IX obstaja možno tveganje za trombembolije, z višjim tveganjem pri manj prečiščenih zdravilih.
Special precautions for disposal and other handling 
Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Special warnings and precautions for use 
Posebna opozorila in previdnostni ukrepi
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of plasma-derived factor IX products. 
Pri bolnikih, ki redno/ponavljajoče prejemajo izdelke iz plazme pridobljenega faktorja IX bi morali razmisliti o ustrezni obliki cepljenja (hepatitis A in B).
If you get any side effects, talk to your doctor, pharmacist or nurse. 
Če opazite katerega koli izmed neželenih učinkov, se posvetujte s zdravnikom, farmacevtom ali medicinsko sestro.
More extensive haemarthrosis, muscle bleeding or haematoma 
Bolj obsežen hemartros, krvavitev v mišico ali hematom
Sodium chloride Sucrose 
Prašek: natrijev klorid saharoza histidin
VIAL OF SOLVENT 5 ml VIAL OF SOLVENT 10 ml 
VIALA VEHIKLA 5 ml VIALA VEHIKLA 10 ml
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription 15. 
NAČIN IZDAJANJA ZDRAVILA Predpisovanje in izdaja zdravila je le na recept.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. 
Kljub temu se možnosti prenosa povzročiteljev okužb pri uporabi zdravil iz krvi ali plazme ne more popolnoma izključiti.
Powder and solvent for solution for injection. 
prašek in vehikel za raztopino za injiciranje
How to store Nonafact 
Shranjevanje zdravila Nonafact
VIAL OF POWDER 500 IU VIAL OF POWDER 1000 IU 
VIALA PRAŠKA 500 i.e. VIALA PRAŠKA 1000 i.e.
Haemorrhage 
Izpuščaji
Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived coagulation factor IX. 
Če redno/ponavljajoče prejemate koagulacijski faktor IX, pridobljen iz človeške plazme, vam bo zdravnik priporočil, da razmislite o cepljenju proti hepatitisu A in B.
INFORMATION IN BRAIILE 17. 
PODATKI V BRAILLOVI PISAVI
NAME OF THE MEDICINAL PRODUCT Nonafact 100 IU/ml powder and solvent for solution for injection. 
IME ZDRAVILA Nonafact 100 i.e./ml prašek in vehikel za raztopino za injiciranje
Nonafact contains 100 IU per ml after reconstitution with water for injection. 
Zdravilo Nonafact vsebuje 100 i.e. na ml po rekonstituciji z vodo za injekcije - Druge sestavine zdravila so natrijev klorid, saharoza, histidin in voda za injekcije.
If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the product immediately and contact their physician Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. 
Bolnike je treba poučiti o zgodnjih znakih preobčutljivostnih reakcij, vključujoč koprivnico, generalizirano koprivnico, občutek tiščanja v prsnem košu, piskajoče in sopihajoče dihanje, hipotenzijo, in o anafilaksiji.
Early haemarthrosis, muscle bleeding or oral bleeding 
Zgodnji hemartros, krvavitev v mišico ali krvavitev v ustni votlini
Keep the container in the outer carton, in order to protect from light. 
Za zagotovitev zaščite pred svetlobo vsebnik shranjujte v zunanji ovojnini.
For storage conditions after reconstitution of the medicinal product, see section 
Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavje 6.3.
Keep the vial in the outer carton in order to protect from light. 
Za zagotovitev zaščite pred svetlobo viale shranjujte v zunanji ovojnini.
Overdose 
Odmerjanje
Major surgery 
Večji kirurški posegi
The product must not be used if any cloudiness, lumps or particulate matter are visible. 
Če so vidne motnjave, grudice ali trdni delci, zdravila ne smete uporabiti.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING 
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Posology 
Operacija
Nonafact 100 IU/ml powder for solution for injection Human coagulation factor IX for intravenous use 
humani koagulacijski faktor IX za intravensko uporabo
Strength Pharmaceutical Form 
Jakost Farmacevtska oblika Pot uporabe Stična ovojnina
Route of Administration Immediate Packaging 
Velikost pakiranja
The corresponding decision from the Commission was issued on 13 July 2011. 
Ustrezna odločitev Komisije je bila izdana 13. julija 2011.
Two initial opinions were issued. 
Izdani sta bili dve prvotni mnenji.
Care should be taken to ensure consistency. 
Posebno pozornost je treba nameniti zagotavljanju doslednosti.
A 12 month monitoring should also be undertaken upon qualification. 
Po kvalifikaciji je treba izvesti tudi 12-mesečno spremljanje.
The investigation supports that a combination of factors have contributed to the findings. 
Preiskava potrjuje, da je na ugotovitve vplivala kombinacija različnih dejavnikov.
These dialysis solutions were thus imported from Canada, Singapore, Turkey and USA. 
Te dializne raztopine so bile tako uvožene iz Kanade, Singapurja, Turčije in ZDA.
The Singaporean manufacturing plant was only used once and no longer considered as an alternative. 
Proizvodni obrat v Singapurju je bil uporabljen samo enkrat in ne velja več kot nadomestna možnost.
In addition to the programme of quality improvement, future assured supply steps were developed. 
Poleg programa za izboljšanje kakovosti so bili oblikovani tudi postopki za zagotovitev oskrbe v prihodnje.
A second opinion was then issued in May 2011 to recommend the inclusion of the site located in USA as an additional manufacturing site. 
Drugo mnenje je bilo nato izdano maja 2011, v njem pa je bila priporočena vključitev proizvodnega obrata v ZDA kot dodatnega proizvodnega obrata.
This should allow early detection of low levels of endotoxin and trend analysis which should provide an early safety warning. 
To naj bi omogočilo zgodnje odkrivanje nizkih ravni endotoksina in analizo trenda, ki naj bi zagotovila zgodnje varnostno opozorilo.
The CHMP requests that the inspection of the Castlebar site be performed by the end of December 2011 and that the outcome of the inspection be provided to national competent authorities. 
CHMP zahteva, da se inšpekcijski pregled obrata v Castlebaru izvede do konca decembra 2011 in da se izid pregleda predloži pristojnim nacionalnim organom.
It was noted that the risk for aseptic peritonitis increased if a patient was using one or several affected bags of batch/batches containing increased levels of endotoxin. 
Ugotovljeno je bilo, da se je tveganje za aseptični peritonitis povečalo, če je bolnik uporabil eno ali več okuženih vrečk iz serije/serij, ki so vsebovale povečane ravni endotoksina.
The CHMP agreed with the proposed studies. 
CHMP je predlagane študije potrdil.
The contingency plan for sufficient/alternative providers/stocks for raw materials was agreed. 
Potrjen je bil načrt ukrepov za zadostno/nadomestno oskrbo/zalogo za surovine.
The product information for dialysis solutions includes the risk of peritonitis. 
Informacije o zdravilu za dializne raztopine vključujejo tveganje za peritonitis.
The first on the inclusion of the sites located in Canada, Poland and Turkey as additional manufacturing sites to the marketing authorisations of the respective peritoneal dialysis solutions was issued by the Committee in April 2011, and the corresponding decision from the Commission was issued on 12 May 2011. 
Prvo mnenje glede vključitve obratov v Kanadi, na Poljskem in v Turčiji kot dodatnih proizvodnih obratov v dovoljenje za promet z zdravilom za zadevne raztopine za peritonealno dializo je Odbor izdal aprila 2011, Komisija pa je ustrezno odločitev izdala dne 12. maja 2011.
Although protein/biofilm were not found upon dismantling the line, Gram positive and Gram negative microorganisms were identified. 
Čeprav pri razstavitvi linije niso odkrili nobenih beljakovin/biofilma, pa so ugotovili prisotnost grampozitivnih in gramnegativnih mikroorganizmov.
Enhancements of the affected line were proposed in order to prevent the occurrence of future biofilm/microbial contamination problems. 
Predlagane so bile izboljšave okužene linije za preprečevanje pojavljanja biofilma/težav z mikrobno kontaminacijo v prihodnje.
Other enhanced pharmacovigilance activities include the clinical audit that will collect data on the number of peritonitis events in the EU and an observational study to assess the severity of peritonitis episodes (including fatal outcomes) and the impact on longer term clinical outcome. 
Preostala ukrepa za povečano farmakovigilanco sta klinična presoja, pri kateri bodo zbrani podatki o številu dogodkov peritonitisa v EU, ter opazovalna študija za oceno resnosti epizod peritonitisa (vključno s smrtnimi izidi) in učinka na klinični izid v daljšem časovnem obdobju.
Monosol and 0.9% sodium chloride for haemodialysis solutions were promptly recalled from the market as alternatives were available. 
Zdravilo Monosol in 0,9 % natrijev klorid za raztopine za hemodializo sta bila takoj umaknjena s trga, saj so bila na voljo druga nadomestna zdravila.
Products manufactured at the affected lines in Castlebar included peritoneal dialysis (PD) solutions Dianeal, Extraneal and Nutrineal; and Monosol and 0.9% sodium chloride for haemodialysis. 
Med zdravili, ki so se proizvajala na okuženih linijah v Castlebaru, so bile raztopine za peritonealno dializo (PD) Dianeal, Extraneal in Nutrineal, zdravilo Monosol ter 0,9 % natrijev klorid za hemodializo.
Dialysis solutions produced at the affected lines are not being released onto the market pending the outcome of this inspection. 
Dializne raztopine, proizvedene na okuženih linijah, se pred izidom tega pregleda ne sproščajo na trg.
Taking into account the crucial nature of these medicinal products, and the need for unaffected batches of dialysis solutions to be made available to patients across the EU in the shortest possible timeframe, alternatives were sought. 
Ob upoštevanju pomena teh zdravil in potrebe, da so neokužene serije dializnih raztopin v najkrajšem možnem času na voljo bolnikom po vsej EU, so se iskala nadomestna zdravila.
New re-designed equipment was installed with the intention of minimising areas where pooling of water/solutions could occur. 
Nameščena je bila nova, preoblikovana oprema, s katero so želeli čim bolj omejiti območja, kjer bi se lahko zbirala voda/raztopine.