natgillin/translations-raw huggingface dataset:
It is available in prefilled syringes containing between 1,000 and 40,000 international units (IU) of the active substance, epoetin zeta.
Na voljo je v obliki napolnjene injekcijske brizge, ki vsebuje od 1 000 do 40 000 mednarodnih enot (i.e.) zdravilne učinkovine epoetin zeta.
Retacrit should not be used in people who may be hypersensitive (allergic) to epoetin zeta or any of the other ingredients.
Zdravila Retacrit ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) epoetin zeta ali katero koli drugo sestavino zdravila.
The iron levels of all patients should be checked before treatment to make sure that they are not too low, and iron supplements should be used throughout treatment.
Pred zdravljenjem je treba pri vseh bolnikih preveriti raven železa in s tem zagotoviti, da njihove vrednosti niso prenizke, med zdravljenjem pa morajo bolniki jemati dodatke, ki vsebujejo železo.
The reference medicine for Retacrit is Eprex/Erypo, which contains epoetin alfa.
Referenčno zdravilo za zdravilo Retacrit je Eprex/Erypo, ki vsebuje epoetin alfa.
In the correction study, haemoglobin levels were around 11.6 g/dl during the last four weeks of the study, having risen from around 8.0 g/dl before treatment.
V zadnjih štirih tednih študije popravljanja so se ravni hemoglobina zvišale na okoli 11,6 g/dl s približno 8,0 g/dl pred zdravljenjem.
The CHMP concluded that, in accordance with EU requirements, Retacrit has been shown to have a comparable quality, safety and efficacy profile to Eprex/Erypo.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Retacrit primerljivo kakovost, varnost in učinkovitost kot zdravilo Eprex/Erypo.
The study in patients receiving chemotherapy showed that Retacrit brought about similar improvements in haemoglobin levels as those reported in the scientific literature for other epoetins.
V študiji pri bolnikih, ki so prejemali kemoterapijo, so dokazali, da je zdravilo Retacrit zagotovilo podobno izboljšanje ravni hemoglobina, kot je opisano v strokovni literaturi za druge epoetine.
In both studies, the main measures of effectiveness were the levels of haemoglobin during treatment, as well as the dose of epoetin received.
V obeh študijah sta bili glavni merili učinkovitosti ravni hemoglobina med zdravljenjem in prejeti odmerek epoetina.
As with other medicines containing an epoetin, the most common side effect with Retacrit is an increase in blood pressure, which can sometimes lead to symptoms of encephalopathy (brain problems) such as sudden stabbing migraine-like headache and confusion.
Kot pri drugih zdravilih, ki vsebujejo epoetin, je najpogostejši neželeni učinek zdravila Retacrit zvišan krvni tlak, ki lahko v posameznih primerih povzroči simptome encefalopatije (možganskih zapletov), kot sta nenaden, migreni podoben, glavobol z zbadanjem in zmedenost.
It must not be used in patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin, patients with hypertension (high blood pressure) that is not controlled, patients about to undergo surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke, or patients who cannot receive medicines to prevent blood clots.
Zdravilo se ne sme uporabljati pri bolnikih, pri katerih se je pojavila čista aplazija rdečih krvnih celic (zmanjšano ali prekinjeno nastajanje rdečih krvnih celic) po zdravljenju s katerim koli eritropoetinom, bolnikih s hipertenzijo (visokim krvnim tlakom), ki ni nadzorovana, bolnikih pred operacijo, ki imajo hude kardiovaskularne težave (težave s srcem in ožiljem), vključno z nedavnim miokardnim infarktom ali kapjo, ali pri bolnikih, ki ne smejo jemati zdravil za preprečevanje nastanka krvnih strdkov.
Retacrit must not be used prior to major bone surgery in patients who have a severe disease affecting their arteries or their blood vessels in the heart, neck or brain, including patients who have recently had a heart attack or stroke.
Zdravilo Retacrit se ne sme uporabljati pred velikim operativnim posegom na kosteh pri osebah z resno boleznijo, ki je prizadela arterije ali krvne žile v srcu, vratu ali možganih, vključno z bolniki, ki so pred nedavnim utrpeli srčni napad ali kap.
In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
Pri bolnikih, ki prejemajo kemoterapijo ali imajo ledvične težave, lahko anemijo povzroči pomanjkanje eritropoetina ali premajhna odzivnost telesa na naravno prisotni eritropoetin.
• to treat anaemia (low red blood cell counts) that is causing symptoms in patients with chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems;
• za zdravljenje anemije (nizkega števila rdečih krvnih celic), ki povzroča simptome pri bolnikih s kronično odpovedjo ledvic (dolgotrajnim in napredujočim zmanjševanjem sposobnosti pravilnega delovanja ledvic) ali drugimi težavami z ledvicami;
Retacrit, injected into a vein, was compared with the reference medicine in two main studies involving 922 patients who had anaemia associated with chronic renal failure requiring haemodialysis (a technique for removing waste products from the blood).
Zdravilo Retacrit, injicirano v veno, so z referenčnim zdravilom primerjali v dveh glavnih študijah, v kateri je bilo vključenih 922 bolnikov z anemijo, ki je bila povezana s kronično ledvično odpovedjo s potrebo po hemodializi (tehniki odstranjevanja odpadnih snovi iz krvi).
Retacrit is a ‘biosimilar' medicine.
Zdravilo Retacrit je „biološko podobno“ zdravilo.
The company also presented the results of two studies looking at the effects of Retacrit injected under the skin: one involved 261 cancer patients receiving chemotherapy, and the other compared Retacrit with Eprex/Erypo in 462 patients with anaemia caused by kidney problems.
Družba je predstavila tudi rezultate dveh študij, v katerih so ugotavljali učinke podkožno injiciranega zdravila Retacrit: ena študija je vključevala 261 bolnikov z rakom, ki so prejemali kemoterapijo, v drugi pa so primerjali zdravilo Retacrit z zdravilom Eprex/Erypo pri 462 bolnikih z anemijo kot posledico težav z ledvicami.
In the study of patients already being treated with an epoetin, haemoglobin levels were maintained at around 11.4 g/dl when the patients were receiving Retacrit and when they were receiving Eprex/Erypo.
V študiji pri bolnikih, ki so se že zdravili z epoetinom, so ravni hemoglobina ostale na ravni približno 11,4 g/dl pri bolnikih, ki so prejemali zdravilo Retacrit ali zdravilo Eprex/Erypo.
For the full list of all side effects reported with Retacrit, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Retacrit, glejte navodilo za uporabo.
Retacrit is a solution for injection.
Zdravilo Retacrit je raztopina za injiciranje.
Why has Retacrit been approved?
Zakaj je bilo zdravilo Retacrit odobreno?
The active substance in Retacrit, epoetin zeta, is a copy of human erythropoietin and works in exactly the same way as the natural hormone to stimulate red blood cell production.
Zdravilna učinkovina v zdravilu Retacrit, epoetin zeta, je kopija človeškega eritropoetina in spodbuja tvorjenje rdečih krvnih celic povsem enako kot naravni hormon.
• to increase the amount of blood that patients with moderate anaemia can self-donate before surgery, so that their own blood can be given back to them during or after surgery;
• za povečanje količine krvi, ki jo lahko bolniki z zmerno slabokrvnostjo dajo pred operacijo in jo nato prejmejo med operacijo ali po njej;
Retacrit can be injected under the skin by the patient or their carer if they have been trained appropriately.
Zdravilo Retacrit si lahko pod kožo vbrizga bolnik sam ali mu ga injicira negovalec, če sta bila za to ustrezno usposobljena.
Therefore, the CHMP's view was that, as for Eprex/Erypo, the benefit outweighs the identified risks.
Zato je menil, da njegove koristi, tako kot pri zdravilu Eprex/Erypo, odtehtajo znana tveganja.
• to reduce the need for blood transfusions in patients with moderate anaemia about to undergo major bone surgery (such as a hip or knee replacement).
• za zmanjšanje potrebe po transfuziji krvi pri bolnikih z zmerno slabokrvnostjo, ki so tik pred velikim operativnim posegom na kosteh (kot je vstavljanje kolka ali kolena).
Retacrit was as effective as Eprex/Erypo in correcting and maintaining red blood cell counts.
Zdravilo Retacrit je bilo enako učinkovito kot zdravilo Eprex/Erypo pri izboljševanju in ohranjanju ravni rdečih krvnih celic.
Erythropoietin is also used before surgery to increase the number of red blood cells to help patients produce more blood for self-donation.
Eritropoetin se uporablja tudi pred kirurškim posegom, da zviša ravni rdečih krvnih celic in tako pripomore k tvorbi večje količine lastne krvi, ki jo bolnik nato prejme med posegom.
All of the patients in the second study had been receiving treatment with Eprex/Erypo for at least three months before they were either switched to Retacrit or remained on Eprex/Erypo for 12 weeks.
V drugi študiji so vse bolnike najmanj tri mesece zdravili z zdravilom Eprex/Erypo, nato pa so za 12 tednov bodisi zamenjali zdravilo z zdravilom Retacrit bodisi še naprej uporabljali zdravilo Eprex/Erypo.
Retacrit can also lead to skin rash and influenza (flu)-like symptoms.
Zdravilo Retacrit lahko povzroči tudi kožne izpuščaje in gripi podobne simptome.
Retacrit was also as effective as the reference medicine in patients with kidney problems.
Zdravilo Retacrit je bilo pri bolnikih z ledvičnimi težavami enako učinkovito kot referenčno zdravilo.
For patients receiving chemotherapy, it must be injected under the skin, and for patients about to undergo surgery, it must be injected into a vein.
Pri bolnikih, ki prejemajo kemoterapijo, je treba zdravilo injicirati pod kožo, pri bolnikih pred kirurškim posegom pa v veno.
A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.
Hormon eritropoetin spodbuja nastajanje rdečih krvnih celic v kostnem mozgu.
Retacrit was also effective when it was injected under the skin.
Zdravilo Retacrit je bilo učinkovito tudi ob podkožnem injiciranju.
How has Retacrit been studied?
Kako je bilo zdravilo Retacrit raziskano?
For patients with kidney problems, Retacrit can be injected into a vein or under the skin.
Zdravilo Retacrit je treba pri bolnikih z ledvičnimi težavami injicirati v veno ali pod kožo.
The second study compared the effects of Retacrit with those of Eprex/Erypo in maintaining red blood cell counts in 313 patients.
V drugi študiji so pri 313 bolnikih primerjali učinke zdravila Retacrit z učinki zdravila Eprex/Erypo pri ohranjanju ravni rdečih krvnih celic.
Retacrit was studied to show that it is comparable with the reference medicine, Eprex/Erypo, in experimental models and in humans.
Za zdravilo Retacrit so s pomočjo poskusnih modelov in pri ljudeh dokazovali, da je primerljivo z referenčnim zdravilom Eprex/Erypo.
What is Retacrit used for?
Za kaj se zdravilo Retacrit uporablja?
How is Retacrit used?
Kako se zdravilo Retacrit uporablja?
The first study compared the effects of Retacrit with those of Eprex/Erypo in correcting red blood cell counts in 609 patients over 24 weeks.
V prvi študiji so pri 609 bolnikih 24 tednov primerjali učinke zdravila Retacrit z učinki zdravila Eprex/Erypo pri izboljševanju ravni rdečih krvnih celic.
What is Retacrit?
Kaj je zdravilo Retacrit?
How does Retacrit work?
Kako zdravilo Retacrit deluje?
For full details, see the package leaflet.
Za dodatne informacije glejte navodilo za uporabo.
The Reference Member State was Germany and the Concerned Member States were Finland and the United Kingdom.
Referenčna država članica je bila Nemčija, zadevni državi članici pa sta bili Finska in Združeno kraljestvo.
London, 21 August 2006 EMEA/CHMP/212746/2006
London, 21. avgust 2006 EMEA/CHMP/212746/2006
A positive opinion was adopted by majority on 1 June 2006.
Pozitivno mnenje je bilo sprejeto z večino glasov dne 1. junija 2006.
The Rapporteur was Dr. Broich and Co-Rapporteurs were Dr. Hudson and Dr. Kuitunen.
Poročevalec je bil dr. Boich, soporočevalca pa sta bila dr. Hudson in dr. Kuitunen.
The arbitration procedure started on 15 September 2005 with the adoption of a list of questions.
Arbitražni postopek se je začel 15. septembra 2005 s sprejetjem seznama vprašanj.
The Mutual Recognition Procedure started on 24 March 2005.
Postopek za medsebojno priznavanje se je začel 24. marca 2005.
The United Kingdom referred the reasons for disagreement to the EMEA on 16 August 2005.
Združeno kraljestvo je agenciji EMEA posredovalo razloge za nesoglasje dne 16. avgusta 2005.
This refers to the dosing recommendation for the newborn and this was considered to be of serious public health concern.
Te se nanašajo na priporočila glede odmerjanja za novorojence, kar predstavlja resne pomisleke v zvezi z javnim zdravjem.
The Marketing Authorisation Holder provided written explanations on 28 November 2005.
Imetnik dovoljenja za promet z zdravilom je pisna pojasnila predložil dne 28. novembra 2005.
The posology in neonates where higher doses were proposed for neonates aged 15-27 days (80 mg/kg) while the standard dose is 20-50mg/kg in the UK for neonates 0-28 days.
V zvezi z odmerjanjem pri novorojencih so bili predlagani višji odmerki za novorojence, stare od 15 do 27 dni (80 mg/kg), medtem ko je v Združenem kraljestvu standardni odmerek 20-50 mg/kg za novorojence, stare od 0 do 28 dni.
Significant difference has been identified with regard to the proposed SPC compared to the SPC of the reference product in the UK.
V zvezi s predlaganim Povzetkom glavnih značilnosti zdravila (SPC) so bile ugotovljene pomembne razlike v primerjavi s SPC referenčnega izdelka v Združenem kraljestvu.
During their May 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Ceftriaxone Tyrol Pharma and associated names, that the objections raised by United Kingdom should
Med svojim zasedanjem maja 2006 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Ceftriaxone Tyrol Pharma in povezana imena ugodno, da ugovori, podani s strani Združenega
Depending on the mode of surgery and the expected spectrum of pathogens ceftriaxone should be combined with an appropriate antimicrobial agent with additional anaerobic coverage.
Odvisno od vrste kirurškega posega in pričakovanega spektra patogenih mikroorganizmov je treba ceftriakson dajati skupaj z ustreznim protimikrobnim sredstvom, ki dodatno deluje na druge anaerobe.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Ceftriaxone Tyrol Pharma and associated names International Non-Proprietary Name (INN): Ceftriaxone
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29(2)1 ZA Ceftriaxone Tyrol Pharma in povezana imena Mednarodno nelastniško ime (INN): Ceftriakson
It is indicated for the treatment of the following infections when caused by micro-organisms that are susceptible to ceftriaxone and if parenteral treatment is necessary:
Indiciran je za zdravljenje spodaj navedenih okužb, kadar jih povzročijo na ceftriakson občutljivi organizmi in če je potrebno parenteralno zdravljenje:
not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
kraljestva, ne bi smeli preprečiti podelitve dovoljenja za promet z zdravilom, ter da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo referenčne države članice dopolniti.
Ceftriaxone Tyrol Pharma and associated names, 1g and 2 g powder for solution for injection/infusion, is an antibiotic, being a third generation cephalosporin.
Ceftriaxone Tyrol Pharma in povezana imena, 1g in 2 g prašek za raztopino za injiciranje/infundiranje je antibiotik, cefalosporin tretje generacije.
Ceftriaxone is indicated for perioperative prophylaxis in patients with a certain risk of severe postoperative infections.
• pljučnica Ceftriakson se uporablja za preprečevanje okužb pri kirurških posegih pri bolnikih, pri katerih obstaja določeno tveganje, da pride do hudih okužb po operaciji.
Sandoz GmbH submitted applications for mutual recognition of Ceftriaxone Tyrol Pharma and associated names, 1g and 2g, solution for injection/infusion on the basis of the marketing authorisation granted by Germany on 13 August 2002.
Družba Sandoz GmbH je predložila vloge za medsebojno priznavanje zdravila Ceftriaxone Tyrol Pharma in povezana imena, 1 g in 2 g prašek za raztopino za injiciranje/infundiranje, na osnovi dovoljenja za promet z zdravilom, ki ga je izdala Nemčija dne 13. avgusta 2002.
The European Commission granted a marketing authorisation valid throughout the European Union for Rixubis on 19 December 2014.
Evropska komisija je dovoljenje za promet z zdravilom Rixubis, veljavno po vsej Evropski uniji, izdala 19 decembra 2014.
It can be used in patients of all ages, and for short-term or long-term use.
Uporablja se lahko pri bolnikih vseh starosti ter je primerno za kratkotrajno ali dolgotrajno uporabo.
What measures are being taken to ensure the safe and effective use of Rixubis?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rixubis?
Other information about Rixubis
Druge informacije o zdravilu Rixubis
The safety profile was considered acceptable and was outweighed by the beneficial effects.
Varnostni profil je bil ocenjen kot sprejemljiv glede na koristi.
The full EPAR and risk management plan summary for Rixubis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Rixubis sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Rixubis.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rixubis.
The effect of treatment in stopping bleeding episodes was rated excellent in 41% of cases and good in a further 55%.
Učinek zdravila pri zaustavljanju epizode krvavitve je bil ocenjen kot odličen v 41 % primerov in kot dober v naslednjih 55 %.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Rixubis's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Rixubis večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
It is not intended to provide practical advice on how to use Rixubis.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
In the first study, involving 73 patients aged 12 to 59 years, 249 bleeding episodes were treated with Rixubis.
V prvi študiji, v kateri je sodelovalo 73 bolnikov, starih od 12 do 59 let, so z zdravilom Rixubis zdravili 249 epizod krvavitev.
A risk management plan has been developed to ensure that Rixubis is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Rixubis je bil pripravljen načrt obvladovanja tveganj.
The evaluation of these studies also indicated that Rixubis was distributed in the body similarly to another approved factor IX product.
Vrednotenje teh študij je tudi nakazalo, da se je zdravilo Rixubis po telesu razporedilo podobno kot drugo odobreno zdravilo s faktorjem IX.
For further information, see the summary of product characteristics (also part of the EPAR).
Za več informacij glejte povzetek glavnih značilnosti zdravila (ki je prav tako sestavni del EPAR).
Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations.
Redko se lahko pojavijo preobčutljivostne (alergijske) reakcije, ki lahko vključuje angioedem (otekanje podkožnih tkiv), pekoč občutek in zbadanje na mestu injiciranja, mrzlico, pordelost, srbeč izpuščaj, glavobol, koprivnico, hipotenzijo (nizek krvni tlak), utrujenost ali nemirnost, navzejo (slabost) ali bruhanje, tahikardijo (hitro bitje srca), tiščanje v prsih, težko dihanje in ščemenje.
A second study involved 23 children aged from just under 2 to nearly 12 years of age, who experienced 26 bleeding episodes during the study: treatment of bleeding episodes was rated as excellent in 50% of cases and good in another 46%, and the average bleeding rate was reduced from 6.8 to 2.7 bleeds per year.
V drugi študiji je sodelovalo 23 otrok, starih od skoraj 2 do skoraj 12 let, pri katerih je med študijo prišlo do 26 epizod krvavitev: zdravljenje epizod krvavitev je bilo ocenjeno kot odlično v 50 % primerov in kot dobro v nadaljnjih 46 %, povprečno število krvavitev pa se je zmanjšalo s 6,8 na 2,7 krvavitve na leto.
This lack causes blood clotting problems, such as bleeding in the joints, muscles or internal organs.
To povzroča zaplete pri strjevanju krvi, kot je krvavenje v sklepe, mišice ali notranje organe.
The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs.
Najpogostejši neželeni učinki zdravila Rixubis (ki lahko prizadenejo največ 1 osebo od 10) so disgevzija (motnje okušanja) in bolečine v okončinah.
With respect to prevention of bleeding, the average bleeding rate during treatment was 4.26 bleeds a year, compared with an average of about 17 per year before enrolment.
Kar zadeva preprečevanje krvavitev, je bilo povprečno število krvavitev 4,26 krvavitve na leto v primerjavi s povprečno 17 na leto pred vključitvijo v študijo.
In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure.
V nekaterih primerih reakcije postanejo hude (anafilaksija) ter so lahko povezane z nevarno naglim in velikim zmanjšanjem krvnega tlaka.
Effectiveness in stopping bleeding was measured on a standard scale in which ‘excellent' meant complete relief of pain and no signs of bleeding after a single dose of the medicine, and ‘good' meant relief of pain and signs of improvement with a single dose, although further doses might be needed for complete resolution.
Učinkovitost pri zaustavljanju krvavitev so merili s standardno lestvico, pri kateri je „odlično“ pomenilo, da bolnik po enem odmerku zdravila ni več čutil bolečine in ni imel več nobenih znakov krvavitve, „dobro“ pa je pomenilo, da se je pri bolniku po enem odmerku zmanjšala bolečina in so bili vidni znaki izboljšanja, vendar pa bi bili za popolno odpravo simptomov morda potrebni nadaljnji odmerki.
The dose and frequency of treatment depend on the patient's bodyweight and whether Rixubis is used to treat or prevent bleeding, as well as the seriousness of the haemophilia, the extent and location of the bleeding and the patient's age and health.
Odmerek in pogostost uporabe zdravila sta odvisna od telesne mase bolnika, tega, ali se zdravilo Rixubis uporablja za zdravljenje ali preprečevanje krvavitev, od resnosti hemofilije, obsega in mesta krvavitve ter bolnikove starosti in zdravja.