natgillin/translations-raw huggingface dataset:
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
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.
All changes to processes, frequencies or limits resulting from the evaluation should also be submitted to the national competent authorities through appropriate regulatory procedures.
Vse spremembe postopkov, pogostnosti ali omejitev, ki bodo posledica ocenjevanja, se morajo prav tako predložiti pristojnim nacionalnim organom v skladu z ustreznimi regulativnimi postopki.
• The Committee requires the MAH to perform the epidemiological studies agreed, the clinical audit and observational study, and other measures as detailed in the risk management plan.
• Odbor zahteva, da imetnik dovoljenja za promet z zdravilom izvede dogovorjene epidemiološke študije, klinično presojo in opazovalno študijo ter druge ukrepe, opisane v načrtu za obvladovanje tveganja.
For completeness, the CHMP considered that a pharmacovigilance inspection should be carried out.
CHMP je menil, da je za zagotovitev celovitosti treba izvesti farmakovigilančni pregled.
On the basis of the proposed measures, the CHMP was reassured that corrective actions are being implemented and will be subject of further monitoring.
Predlagani ukrepi so CHMP zagotovili, da se izvajajo ustrezni korektivni ukrepi, ki se bodo preverjali z nadaljnjim spremljanjem.
• The Committee considers that the future supply programme submitted by the MAH adequate.
• Odbor ocenjuje, da je program oskrbe v prihodnosti, ki ga je predložil imetnik dovoljenja za promet z zdravilom, primeren.
Overall, a combination of factors may have played a role in the findings, such as inadequately designed equipment, mechanical failure of equipment (cracks having been detected in some tanks used in the affected lines), methods of microbial monitoring not applied routinely and not state of the art, including outdated methods for monitoring endotoxins, and an inadequate cleaning and sanitisation regimen.
Na splošno je na te ugotovitve verjetno vplivala kombinacija različnih dejavnikov, kot so neustrezno izdelana oprema, mehanske napake opreme (v nekaterih rezervoarjih, ki so se uporabljali v okuženih linijah, so bile odkrite razpoke), metode mikrobnega nadzorovanja niso bile sodobne in se niso rutinsko izvajale, kar velja tudi za zastarelo metodo nadzorovanja endotoksinov, ter neustrezni sistem čiščenja in sanacije.
A plan for maintenance of existing manufacturing sites, registration of additional sites located in Italy and the UK, expansion of different sites to increase its capacity and contingency for sufficient alternative providers/stocks for raw materials was agreed.
Potrjen je bil tudi načrt za ohranitev obstoječih proizvodnih obratov, registracijo dodatnih obratov v Italiji in Združenem kraljestvu ter razširitev različnih obratov za povečanje zmogljivosti in razpoložljivosti za zadostne nadomestne ponudnike/zaloge za surovine.
The MAH's plan for maintenance of existing manufacturing sites, registration of additional sites and expansion of production capacity of others is appropriate.
Načrt imetnika dovoljenja za promet z zdravilom za ohranitev obstoječih proizvodnih obratov, registracijo dodatnih proizvodnih obratov in povečanje proizvodnih zmogljivosti drugih obratov je ustrezen.
The CHMP is now in a position to issue a third and final opinion on the article 31 review procedure focusing on the issues at the Castelbar site.
CHMP lahko zdaj izda tretje in končno mnenje v zvezi s postopkom pregleda v skladu s členom 31, s poudarkom na težavah v proizvodnem obratu v Castlebaru.
Considering the likelihood of prolonged use of large quantities of imported PD solutions on the EU market, and in order to ensure continued supply of licensed medicinal products to the European Union, the necessary data packages to support the inclusion of additional manufacturing sites were expedited within the article 31 referral procedure.
Ob upoštevanju verjetnosti podaljšane uporabe večjih količin uvoženih raztopin za PD na trgu EU in za zagotovitev nemotene oskrbe z odobrenimi zdravili v Evropski uniji so bili v okviru napotitvenega postopka iz člena 31 v podporo vključitvi dodatnega proizvodnega obrata pospešeno poslani potrebni podatkovni paketi.
In view of severe supply limitations for Dianeal, Extraneal and Nutrineal and the risk of switching patients to alternative PD solutions or therapies, the CHMP considered that the use of comparable products produced by Baxter at alternative manufacturing sites outside the EEA (European Economic Area) should be prioritised, as these products were assessed to be therapeutically equivalent to the EU products, and there was sufficient reassurance regarding their quality.
Zaradi hudih omejitev oskrbe z zdravili Dianeal, Extraneal in Nutrineal ter tveganja za bolnike zaradi zamenjave zdravila z nadomestnimi raztopinami ali terapijami za PD, je CHMP menil, da je uporaba primerljivih zdravil, ki jih proizvaja družba Baxter v drugih proizvodnih obratih zunaj EGS (Evropskega gospodarskega prostora), prednostna, saj je bilo ocenjeno, da so ta zdravila terapevtsko enakovredna zdravilom iz EU, obstajala pa so tudi ustrezna zagotovila glede njihove kakovosti.
This period of intense monitoring will bring further reassurance that the site is performing to acceptable standards.
To obdobje intenzivnega spremljanja bo še dodatno potrdilo, da obrat deluje v skladu s sprejemljivimi standardi.
Weekly reports will be reintroduced for eight weeks followed by four monthly reports once solutions from the Castlebar plant using the new manufacturing lines are produced.
Za obdobje osmih tednov bodo ponovno uvedena tedenska poročila, po začetku izdelave raztopin na novih proizvodnih linijah v obratu v Castlebaru pa bodo sledila štiri mesečna poročila.