natgillin/translations-raw huggingface dataset:
The usual starting dose is 100 micrograms every two weeks, which can be increased gradually until the levels of red blood cells are sufficiently low and stable.
Običajni začetni odmerek je 100 mikrogramov vsaka dva tedna, ki se lahko postopoma povečuje, dokler ravni rdečih krvnih celic niso dovolj nizke in stabilne.
If side effects occur, the doctor can reduce the dose or stop treatment temporarily.
Če se pojavijo neželeni učinki, lahko zdravnik začasno zmanjša odmerek ali prekine zdravljenje.
In addition, the fact that Besremi does not have the potential to cause gene mutations was considered an important benefit.
Poleg tega je bilo dejstvo, da zdravilo Besremi ne more povzročiti genskih mutacij, ocenjeno kot pomembna korist.
The European Medicines Agency therefore decided that Besremi's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Besremi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/EU311932.
Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/medicines/human/orphan-designations/EU311932.
The patients' spleen may also become larger as it tries to remove excess cells.
Prav tako se lahko poveča bolnikova vranica, saj poskuša odstraniti odvečne celice.
What benefits of Besremi have been shown in studies?
Kakšne koristi je zdravilo Besremi izkazalo v študijah?
It must not be used in patients with thyroid disease which is not controlled by standard treatment, patients who have had psychiatric illnesses such as severe depression, patients with severe problems affecting the heart and the blood vessels, patients who have recently had a heart attack or stroke, patients suffering from autoimmune diseases, patients who have had a transplant, and patients with very severe liver or kidney disease.
Ne sme se uporabljati pri bolnikih z boleznijo ščitnice, ki ni nadzorovana s standardnim zdravljenjem, bolnikih z duševnimi boleznimi, kot so huda depresija, bolnikih s hudimi težavami, ki prizadenejo srce in krvne žile, bolnikih, ki so pred kratkim doživeli srčni napad ali možgansko kap, bolnikih z avtoimunskimi boleznimi, bolnikih, ki so prestali presaditev, in bolnikih z zelo resnimi obolenji jeter ali ledvic.
What are the risks associated with Besremi?
Kakšna tveganja so povezana z zdravilom Besremi?
Besremi must not be used together with telbivudine (a medicine for treating hepatitis B).
Zdravilo Besremi se ne sme uporabljati skupaj z telbivudinom (zdravilom za zdravljenje hepatitisa B).
This starts several reactions that cause the bone marrow to produce fewer red blood cells.
To sproži več reakcij, zaradi katerih kostni mozeg proizvede manj rdečih krvnih celic.
In this study, 43% of patients receiving Besremi had normal red blood cell counts after one year of treatment; 46% of patients receiving another medicine, hydroxycarbamide, had similar improvements.
V tej študiji je 43 % bolnikov, ki so prejemali zdravilo Besremi, imelo po enem letu zdravljenja normalne ravni rdečih krvnih celic; pri 46 % bolnikov, ki so prejemali drugo zdravilo, hidroksikarbamid, je prišlo do podobnih izboljšav.
What is Besremi and what is it used for?
Kaj je zdravilo Besremi in za kaj se uporablja?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Besremi have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Besremi upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Further information on Besremi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/besremi.
Nadaljnje informacije o zdravilu Besremi so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/besremi.
An overview of Besremi and why it is authorised in the EU
Pregled zdravila Besremi in zakaj je odobreno v EU
Why is Besremi authorised in the EU?
Zakaj je zdravilo Besremi odobreno v EU?
The most common side effects with Besremi (which may affect more than 1 in 10 people) are low levels of white blood cells and platelets (blood components that help the blood to clot), muscle and joint pain, tiredness, flu-like symptoms and increased blood levels of gamma-glutamyl transferase (a sign of liver problems).
Najpogostejši neželeni učinki zdravila Besremi (ki lahko prizadenejo več kot 1 osebo od 10) so nizke ravni belih krvnih celic in krvnih ploščic (komponent krvi, ki pomagajo pri strjevanju krvi), bolečine v mišicah in sklepih, utrujenost, gripi podobni simptomi ter zvišane ravni encimov gama-glutamiltransferaze v krvi (znak težav z jetri).
As for all medicines, data on the use of Besremi are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Besremi stalno spremljajo.
For more information about using Besremi, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Besremi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Although Besremi may be less effective than hydroxycarbamide in the first months of treatment, phlebotomy (a procedure to remove excess blood from the body) can help to control the condition in the short term.
Čeprav je lahko zdravilo Besremi v prvih mesecih zdravljenja manj učinkovito od hidroksikarbamida, lahko flebotomija (postopek za odstranitev odvečne krvi iz telesa) pomaga nadzorovati stanje v kratkem obdobju.
Side effects reported with Besremi are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Besremi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Other information about Besremi
Druge informacije o zdravilu Besremi
Besremi is a medicine used to treat polycythaemia vera in adults who do not have symptoms of an enlarged spleen.
Besremi je zdravilo, ki se uporablja za zdravljenje prave policitemije pri odraslih, ki nimajo simptomov povečane vranice.
In patients with polycythaemia vera, the body produces too many red blood cells, which can cause the blood to thicken and reduce blood flow to the organs.
Pri bolnikih s pravo policitemijo telo proizvaja preveč rdečih krvnih celic, kar lahko povzroči, da se kri zgosti in zmanjša pretok krvi v organe.
In Besremi, the interferon has been 'pegylated' (attached to a chemical called polyethylene glycol) so that it can stay longer in the body and be given less often.
V zdravilu Besremi je interferon pegiliran (vezan na kemikalijo, imenovano polietilenglikol), da lahko ostane dlje časa v telesu in se daje manj pogosto.
Polycythaemia vera is rare, and Besremi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 December 2011.
Prava policitemija je redka bolezen, zato je bilo zdravilo Besremi 9. decembra 2011 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Ropeginterferon alfa-2b is a type of 'interferon', a natural substance produced by the body.
Ropeginterferon alfa-2b je vrsta interferona, naravne snovi, ki jo proizvaja telo.
An extension of this study showed that continuing treatment with Besremi for longer increased the number of patients whose blood counts reduced to normal.
Podaljšanje te študije je pokazalo, da je nadaljevanje zdravljenja z zdravilom Besremi, povečalo število bolnikov, pri katerih se je število krvnih celic znižalo na običajno.
Besremi is effective at reducing the excessive number of blood cells in patients with polycythaemia vera, and the proportion of patients improving increased with longer treatment.
Zdravilo Besremi je učinkovito pri zmanjševanju prevelikega števila krvnih celic pri bolnikih s pravo policitemijo, delež bolnikov, pri katerih se stanje izboljša, pa se z daljšim zdravljenjem še poveča.
A main study of 257 patients showed that Besremi is effective at reducing levels of red blood cells in patients with polycythaemia vera.
Glavna študija, v katero je bilo vključenih 257 bolnikov, je pokazala, da je zdravilo Besremi učinkovito pri zmanjševanju ravni rdečih krvnih celic pri bolnikih s pravo policitemijo.
Besremi is available for injection under the skin in pre-filled pens.
Zdravilo Besremi je na voljo v obliki raztopine za injiciranje pod kožo v napolnjenih peresnikih.
The active substance in Besremi, ropeginterferon alfa-2b, works by attaching to receptors (targets) on body cells called interferon alfa/beta receptors (IFNAR).
Učinkovina v zdravilu Besremi, ropeginterferon alfa-2b, deluje tako, da se veže na receptorje (prijemališča) v celicah telesa, imenovane interferon alfa/beta.
Besremi can only be obtained with a prescription and treatment should only be started under the supervision of a doctor experienced in managing polycythaemia vera.
Predpisovanje in izdaja zdravila Besremi je le na recept, zdravljenje z njim pa se sme uvesti samo pod nadzorom zdravnika z izkušnjami z zdravljenjem prave policitemije.
As for its safety, the side effects of Besremi are considered manageable.
Kar zadeva njegovo varnost, veljajo neželeni učinki zdravila Besremi za obvladljive.
How does Besremi work?
Kako zdravilo Besremi deluje?
Besremi contains the active substance ropeginterferon alfa-2b.
Zdravilo Besremi vsebuje učinkovino ropeginterferon alfa-2b.
How is Besremi used?
Kako se zdravilo Besremi uporablja?
For the full list of side effects of Besremi, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Besremi, glejte navodilo za uporabo.
In addition, an updated RMP should be submitted:
Poleg tega je treba posodobljen RMP predloţiti:
Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly around the world.
Pandemična gripa je oblika gripe, ki se pojavi vsakih nekaj desetletij in se hitro razširi po vsem svetu.
Siena, Italy.
Siena, Italija
• if you have a severe infection with a high temperature (over 38°C).
• če imate hudo okuţbo z visoko telesno temperaturo (več kot 38 °C).
These side effects usually disappear within 1-2 days without treatment.
Ti neţeleni učinki običajno izzvenijo v 1-2 dneh brez zdravljenja.
Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant.
Povejte zdravniku, če ste noseči, mislite, da ste morda noseči ali načrtujete zanositi.
Other rare side effects observed after routine use:
Drugi redki neţeleni učinki, ki so jih opazili po rutinski uporabi:
Trial on different vaccination schedules:
c) Preskušanja z različnimi reţimi cepljenja:
Immunogenicity was assessed in a subset (n=197) of study population.
Imunogenosti so ocenili v podskupini (n = 197) populacije v študiji.
b) Long term booster immune memory
b) Dolgoročni obnovitveni imunski spomin
• if you are having a blood test to look for evidence of infection with certain viruses.
• če ste imeli krvni pregled zaradi znakov okuţbe z nekaterimi virusi.
All control animals died within 7 days of challenge.
Vse kontrolne ţivali so v roku 7 dni od provokacije poginile.
Via Fiorentina, 1 - 53100 Siena
Via Fiorentina 1, 53100 Siena Italija
Animals were monitored for 16-17 days after challenge to allow for a comprehensive assessment of disease progression, including the time of onset of symptoms, mortality, or subsequent recovery.
Ţivali so spremljali 16-17 dni po provokaciji, kar je omogočilo izčrpno ocenitev napredovanja bolezni, vključno s časom od pojava simptomov, smrtnosti ali naknadnega okrevanja.
There were 3678 subjects 18-60 years of age, 264 subjects 61-70 years of age, and 41 subjects greater than 70 years of age.
3.678 oseb je bilo starih med 18 in 60 let, 264 oseb med 61 in 70 let in 41 oseb je bilo starejših od 70 let.
During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Med pandemskimi razmerami pogostnost predloţitve poročil o varnosti zdravila, ki je določena v členu 24 Uredbe (ES) št. 726/2004, ne bo zadostovala za spremljanje varnosti pandemičnega cepiva, za katerega se v kratkem času pričakuje visoka stopnja izpostavljenosti.
Currently available data in subjects aged 6 months to 18 years of age are described in section 5.1 but no recommendation on a posology can be made.
Trenutno razpoloţljivi podatki pri preiskovancih, starih od 6 mesecev do 18 let, so opisani v poglavju 5.1, vendar priporočil o odmerjanju ni mogoče dati.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
V skladu s smernico CHMP o sistemih za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen RMP predloţen hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
• Supportive data in adults a)
• Podporni podatki za odrasle a) Kriţne reakcije
Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Zelo pogosti (≥1/10) Pogosti (≥1/100 do <1/10) Občasni (≥1/1.000 do <1/100) Redki (≥1/10.000 do <1/1.000) Zelo redki (<1/10.000)
Some of the undesirable effects mentioned under section 4.8 may affect the ability to drive or operate machinery.
Nekateri neţeleni učinki, navedeni v poglavju 4.8, lahko vplivajo na sposobnost voţnje in upravljanja s stroji.
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
• v 60 dneh po doseţenem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja),
• Available data in paediatric populations
• Razpoloţljivi podatki za pediatrično populacijo
For a full list of excipients see section 6.1.
Za celoten seznam pomoţnih snovi glejte poglavje 6.1.
The symptoms of pandemic flu are similar to those of an ordinary flu but may be more severe.
Simptomi pandemične gripe so podobni simptomom navadne gripe, a so običajno hujši.
Official batch release: in accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Uradna sprostitev serije: v skladu s 114. členom dopolnjene in spremenjene Direktive 2001/83/ES, serijo uradno sprosti drţavni laboratorij ali laboratorij, določen v ta namen.
Compared to the adjuvant control group, lung damage was reduced in vaccinated groups.
V primerjavi s kontrolno skupino z adjuvansom so bile poškodbe pljuč v cepljeni skupini manjše.
MN results yielded a GMR against A/turkey/Turkey/05 ranging from 1.59 to 2.95.
Rezultati MN so pokazali GMR proti sevu A/turkey/Turkey/05 v razponu od 1,59 do 2,95.
Any unused vaccine and waste material should be disposed of in compliance with local requirements.
Neuporabljeno cepivo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
* In the absence of CHMP immunogenicity criteria for children, the CHMP immunogenicity criteria used to evaluate seasonal flu vaccines in adults were applied to the serological data obtained after vaccination of children.
* V odsotnosti kriterijev CHMP za imunogenost za otroke so bili za ocenitev seroloških podatkov po cepljenju otrok uporabljeni kriteriji CHMP za imunogenost za ocenitev sezonskih cepiv proti gripi za odrasle.
In the clinical trials with the vaccine, most side effects were mild in nature and short term.
V kliničnih študijah s cepivom je bila večina neţelenih učinkov blagih in kratkotrajnih.
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Obvestite svojega zdravnika ali medicinsko sestro, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, ali če ste bili cepljeni z drugim cepivom.
These transitory false positive results may be due to IgM production in response to the vaccine.
Prehodno laţni pozitivni rezultati so lahko posledica nastajanja protiteles IgM kot odziv na cepivo.
Control animals received adjuvant alone.
Ţivali v kontrolni skupini so prejemale samo adjuvans.
In addition, the side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent flu.
Dodatno so se učinki, opisani v nadaljevanju, pojavili v dnevih in tednih po cepljenju s cepivi, ki se rutinsko uporabljajo vsako leto za preprečevanje gripe.
It should be noted that the adverse reactions may be intensified.
Opozoriti je treba, da so lahko neţeleni učinki izrazitejši.
Efficacy against challenge with the heterologous virus A/Indonesia/5/05 was also tested.
Testirali so tudi učinkovitost pred provokacijo s heterolognim virusom seva A/Indonesia/5/05.
5.2 Pharmacokinetic properties Not applicable.
5.2 Farmakokinetične lastnosti Navedba smiselno ni potrebna.
Irrespective of antigen dose, almost all systemic reactions were reported on the day of vaccination (day 1) or during the 3 days immediately following.
Ne glede na odmerek antigena so o skoraj vseh sistemskih neţelenih učinkih poročali na dan cepljenja (1. dan) ali v 3 dneh naslednjih dneh.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
The percentages of subjects reporting local reactions were higher in the older age groups, mainly due to the higher reports for pain.
Odstotek oseb, ki so poročale o lokalnih reakcijah, je bil višji v skupini s starejšimi bolniki, preteţno zaradi več poročil o bolečinah.
In addition, duration a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
Poleg tega med trajanjem pandemije viri, potrebni za poglobljeno vrednotenje periodičnih poročil o varnosti zdravila v obliki, kot je definirana v Pravilih, ki urejajo zdravila v Evropski skupnosti „Rules Governing Medicinal Product in the European Union - Volume 9a“ morda ne bodo zadostovali za hitro identifikacijo novih varnostnih izsledkov.
The sideeffects are generally similar to those related to the seasonal flu vaccine.
Neţeleni učinki so bili na splošno podobni kot pri cepivu proti sezonski gripi.
Uncommon: Flu like symptoms.
Občasni: Gripi podobni simptomi
Consistent with the data observed by trial for solicited reactions, there was a general trend towards decreased reports of local reactions after the second vaccination compared with the first injection.
Skladno s podatki, ki so jih opazili v preskušanjih pričakovanih neţelenih učinkov, je splošni trend kazal upad poročil za lokalne neţelene učinke po drugem cepljenju v primerjavi s prvo injekcijo.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Če katerikoli neţeleni učinek postane resen ali če opazite katerikoli neţeleni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
Healthcare providers need to assess the benefit and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations.
Zdravstveni delavci morajo oceniti koristi in moţna tveganja cepljenja nosečih ţensk ob upoštevanju uradnih priporočil.
In consequence, as soon as the pandemic is declared and the prepandemic vaccine is used, the MAH shall submit more frequent simplified periodic safety update reports with a format and a periodicity defined in the "CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context" (EMEA/49993/2008), and any subsequent update.
Imetnik dovoljenja za promet z zdravilom mora zato takoj po razglasitvi pandemije in uporabi prepandemičnega zdravila pogosteje predajati redna poenostavljena posodobljena poročila o varnosti zdravila v obliki in s pogostnostjo, opredeljeni v „CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context“ (EMEA/49993/2008) in v vseh nadaljnjih dopolnitvah.
Vasculitis with transient renal involvement and exudative erythema multiforme.
Vaskulitis s prehodno vpletenostjo ledvic in eksudativnim multiformnim eritemom
MARKETING AUTHORISATION NUMBER EU/1/10/657/001 1 prefilled syringe EU/1/10/657/002 10 prefilled syringes
EU/1/10/657/001 1 napolnjena injekcijska brizga EU/1/10/657/002 10 napolnjenih injekcijskih brizg
In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
V vseh zgoraj naštetih primerih OBVESTITE SVOJEGA ZDRAVNIKA, saj morda cepljenje ni priporočljivo ali ga je treba preloţiti na kasneje.
Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Zato morajo zdravstveni delavci oceniti prednosti in moţna tveganja, povezana z dajanjem zdravila, pri bolnikih s trombocitopenijo ali motnjami krvavitev, ki kontraindicirajo intramuskularno injiciranje, razen kadar so moţne koristi večje od tveganja krvavitev.
If any of these side effects occur, please tell your doctor or nurse immediately.
Če se pojavi katerikoli od teh neţelenih učinkov, takoj obvestite svojega zdravnika ali medicinsko sestro.
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predloţen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trţenja zdravila.
The side effects listed below have occurred in the days or weeks after vaccination with Focetria H1N1v vaccine.
Spodaj našteti neţeleni učinki so se pojavili v dneh ali tednih po cepljenju s cepivom Focetria (H1N1v).
Adverse reactions from clinical trial in children (6 months to 17 years old) (Study V87P6)
Neţeleni učinki iz kliničnih preskušanj pri otrocih (starih od 6 mesecev do 17 let) (študija V87P6)
This medicinal contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per 0.5 ml dose, i.e. essentially sodium- and potassium-free.
To cepivo vsebuje manj kot 1 mmol natrija (23 mg) in manj kot 1 mmol kalija (39 mg) na odmerek 0,5 ml, kar pomeni, da je v bistvu brez natrija in kalija.
SRH antibody response against an homologous H5N1 Vietnam strain at day 43 reached all CHMP criteria for all 3 strains.
Protitelesni odziv SRH proti homolognemu viru H5N1 Vietnam je 43. dan dosegel vse kriterije po CHMP za vse 3 seve.
MN results, similar to SRH results demonstrated strong immune response after completion of priming vaccination series in a population of elderly subjects.
Podobno kot rezultati SRH kaţejo tudi rezultati MN močan imunski odgovor po končani seriji primarnega cepljenja v populaciji starejših oseb.
Very commonly reported reactions in the 36 months to 17 years of age group were pain, headache and fatigue.
Neţeleni učinki, ki so se v skupini otrok, starih med 36 meseci in 17 leti, opazili zelo pogosto, so bili bolečina, glavobol in utrujenost.
If they persist, CONSULT YOUR DOCTOR.
Če ne izzvenijo, SE POSVETUJTE Z ZDRAVNIKOM.
A study in rabbits did not indicate reproductive or developmental toxicity (see section 5.3).
Študija pri kuncih ni pokazala vpliva na sposobnost razmnoţevanja ali razvoja (glejte poglavje 5.3).