natgillin/translations-raw huggingface dataset:
With regard to the delay of vaccination in subject who have received human gammaglobulins or a blood transfusion the CHMP was of the opinion that a longer interval between immunoglobulin or other blood product and subsequent vaccination is recommended in case of administration of high dose such as the one given in patients with Kawasaki Disease (2g/kg).
Ni podatkov, ki bi podprli uporabo cepivo PRIORIX s katerimi koli drugimi cepivi.“ Glede poznejšega cepljenja oseb, ki so prejele transfuzijo humanih gamaglobulinov ali krvi, je bil CHMP mnenja, da je treba v primeru velikih odmerkov, denimo takih, kot jih prejemajo bolniki s Kawasakijevo boleznijo (2 g/kg), priporočiti daljši interval med transfuzijo imunoglobulina ali drugih krvnih pripravkov in cepljenjem.
The summary of product characteristics (SmPC) adopted in the member states in the MRP and the member states in the national procedures are slightly different.
Povzetek glavnih značilnosti zdravila, ki je bil sprejet v državah članicah v postopku z medsebojnim priznavanjem, se nekoliko razlikuje od nacionalno odobrenih povzetkov glavnih značilnosti zdravila v državah članicah.
The CHMP noted that since vaccination of measles, mumps rubella vaccine is generally contraindicated in pregnant women only limited data of spontaneous abortion, malformations and congenital rubella syndrome in the offspring following vaccination with Priorix are available.
CHMP je ugotovil, da so podatki o spontanih splavih, malformacijah in kongenitalnem sindromu rdečk pri potomstvu žensk, cepljenih s cepivom Priorix, omejeni, saj je cepljenje proti ošpicam, mumpsu in rdečkam pri nosečnicah načeloma kontraindicirano.
The method of administration of Priorix is subcutaneous injection, although it can also be given by intramuscular injection.
Odmerek rekonstituiranega cepiva Priorix je za vse države 0,5 ml. Cepivo Priorix se daje v obliki subkutane injekcije, čeprav se ga lahko injicira tudi intramuskularno.
Nervous System (CNS) disorders be reworded as follows “Due caution should be employed in administration of PRIORIX to individuals with Central Nervous System (CNS) disorder, susceptibility to febrile convulsions or family history of convulsions.
Ker ni razpoložljivih podatkov o imunogenosti glede vpliva profilaktične uporabe antipiretikov, je bilo priporočeno, da se odstavek o cepljenju posameznikov z motnjami osrednjega živčnega sistema s cepivom Priorix preoblikuje sledeče: „Pri cepljenju posameznikov z motnjami osrednjega živčnega sistema, dovzetnostjo za vročinske krče ali s konvulzijami v družinski anamnezi je potrebna ustrezna previdnost.
Given the severe course of wild type measles infection in patients with advanced HIV infection, it is recommended by the World Health
Zaradi resnega poteka okužbe z ošpicami divjega tipa pri bolnikih z napredovalo okužbo z virusom HIV Svetovna zdravstvena organizacija (SZO) priporoča rutinsko cepljenje otrok in odraslih, okuženih z virusom HIV, ki ne kažejo simptomov, vendar so potencialno dovzetni za okužbo.
The MAH also proposed to add a specific sub-section on the paediatric population as per the SmPC guideline.
Imetnik dovoljenja za promet z zdravilom je predlagal tudi, da se v skladu s smernicami za povzetek glavnih značilnosti zdravila doda posebno podpoglavje za pediatrično populacijo.
The CHMP agreed that the sentence regarding fructose intolerance should change from “Patients with rare hereditary problems of fructose intolerance should not take this medicine.” to “Patients with rare hereditary problems of fructose intolerance should not be vaccinated with PRIORIX since it contains sorbitol”.
CHMP se je strinjal, da je treba stavek o intoleranci za fruktozo spremeniti iz „Bolniki z redko dedno intoleranco za fruktozo ne smejo prejeti tega zdravila.“ v „Bolniki z redko dedno intoleranco za fruktozo ne smejo biti cepljeni s cepivom PRIORIX, ker vsebuje sorbitol.“ Bilo je odločeno, da se navedba o nosečnosti v poglavju 4.4 briše, saj se v skladu s smernicami o oceni tveganja zdravila za sposobnost razmnoževanja in dojenje pri ljudeh - od podatkov do označevanja (EMEA/CHMP/203927/2005) - nosečnost navaja samo v poglavjih 4.3 in 4.6.
However, none of the field (outbreak) studies provided by the MAH
Vendar pa nobena terenska študija (o izbruhu), ki jo je predložil imetnik dovoljenja za promet z zdravilom, ni navajala podatkov, specifičnih za cepivo Priorix.
• the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holder(s) have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Priorix and associated names (see Annex I).
je CHMP priporočil dopolnitev dovoljenj za promet z zdravilom, za katere so v Prilogi III za zdravilo Priorix in povezana imena na voljo povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo (glejte Prilogo I).
Only if the child is confirmed or suspected to be immunodeficient, risks and benefits of vaccinating its lactating mother should be outweighed.
Razmerje med koristmi in tveganjem pri cepljenju doječe matere je treba pretehtati samo pri potrjeni imunski pomanjkljivosti otroka ali pri sumu nanjo.
These patients should be monitored carefully for signs of measles, parotitis and rubella.” Regarding the paragraph on transmission the proposal of the MAH was considered in principle acceptable by the CHMP with the addition that not only rubella but also measles pharyngeal excretion is known to appear.
Pri odstavku o prenosu bolezni je CHMP upošteval predlog imetnika dovoljenja za promet z zdravilom, da se doda besedilo o tem, da je znano, da se iz grla ne izloča samo virus rdečk, temveč tudi ošpic.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom na dan.
The main measure of effectiveness was based on the number of patients whose disease got worse or who died.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se je bolezen poslabšala oziroma so umrli.
The European Commission granted a marketing authorisation valid throughout the European Union for Norvir on 26 August 1996.
Evropska komisija je dovoljenje za promet z zdravilom Norvir, veljavno po vsej Evropski uniji, izdala 26. avgusta 1996.
It should be taken with food.
Zdravilo je treba zaužiti skupaj s hrano.
What measures are being taken to ensure the safe and effective use of Norvir?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Norvir?
For younger patients, the recommended dose depends on the body surface area (calculated using the patient's height and weight).
Pri mlajših bolnikih je priporočeni odmerek odvisen od telesne površine (izračunane glede na telesno višino in maso bolnika).
The full EPAR for Norvir 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) za zdravilo Norvir je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The recommended dose for adults (aged 18 years or over) is 600 mg twice a day.
Priporočeni odmerek zdravila za odrasle (stare 18 let ali več) je 600 mg dvakrat
This means that it blocks a viral enzyme called protease, which is involved in the reproduction of HIV.
To pomeni, da zavira virusni encim, imenovan proteaza, ki sodeluje pri razmnoževanju virusa HIV.
Other information about Norvir
Druge informacije o zdravilu Norvir
It is available as an oral solution (80 mg/ml), as a powder for oral solution (100 mg sachets), as capsules (100 mg) and as tablets (100 mg).
Na voljo je v obliki peroralne raztopine (80 mg/ml), praška za peroralno raztopino (100 mg vrečke), kapsul (100 mg) in tablet (100 mg).
This is a summary of the European public assessment report (EPAR) for Norvir.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Norvir.
The main measure of effectiveness was the change in the levels of HIV in the blood (viral load) and CD4 T cell levels in the blood (CD4 cell count).
Glavni merili učinkovitosti sta bili sprememba koncentracije virusa HIV v krvi (virusnega bremena) in raven T-celic CD4 v krvi (števila celic CD4).
A risk management plan has been developed to ensure that Norvir is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Norvir je bil pripravljen načrt obvladovanja tveganj.
For more information about treatment with Norvir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Norvir preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This causes an increase of antiviral levels in the blood of such medicines and thus it boosts their antiviral activity.
Tako se poveča raven protivirusne učinkovine teh zdravil v krvi zviša, kar okrepi njihovo protivirusno dejavnost.
In the first study of Norvir as an antiviral medicine, 16% of the Norvir-treated patients (86 out of 543) experienced a worsening of disease or died, compared with 33% of the patients taking placebo (181 out of 547).
V prvi študiji zdravila Norvir kot protivirusnega zdravila je do poslabšanja ali smrti prišlo pri 16 % bolnikov (86 od 543), ki so se zdravili z zdravilom Norvir, v primerjavi s 33 % bolnikov (181 od 547), ki so jemali placebo.
What benefit has Norvir shown during the studies?
Kakšne koristi je zdravilo Norvir izkazalo med študijami?
When it is used as an HIV medicine, the most common side effects with Norvir (seen in more than 1 patient in 10) are dysgeusia (taste disturbances), paraesthesia (unusual tingling sensations) around the mouth and in the limbs, headache, dizziness, peripheral neuropathy (damage to the nerves in the limbs), pharyngitis (sore throat), mouth and throat pain, cough, abdominal pain (stomach ache), nausea (feeling sick), diarrhoea, vomiting, dyspepsia (heartburn), pruritis (itching), rash, joint and back pain, tiredness, flushing and feeling hot.
Kadar pa se zdravilo Norvir uporablja kot zdravilo proti virusu HIV, so njegovi najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku od 10) disgevzija (motnje okušanja), parestezija (nenavadni občutki gomazenja) v predelu ust in v okončinah, glavobol, omotica, periferna nevropatija (poškodba živcev v okončinah), faringitis (vneto žrelo), bolečine v ustih in grlu, kašelj, bolečine v trebuhu, navzeja (občutek slabosti), driska, bruhanje, dispepsija (zgaga), pruritis (srbenje), izpuščaji, bolečine v sklepih in hrbtu, utrujenost, zardevanjein občutek vročine.
The CHMP decided that Norvir's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Norvir večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Norvir is used in combination with other HIV medicines to treat patients over two years of age who are infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Zdravilo Norvir se uporablja v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV pri bolnikih, starejših od dveh let, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
Norvir has been studied as an antiviral medicine in two main studies involving 1,446 patients.
Zdravilo Norvir so raziskali v dveh glavnih študijah, ki sta vključevali 1 446 bolnikov.
Norvir does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Norvir ne zdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Norvir.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Treatment with Norvir should be given by a doctor who has experience in the treatment of HIV infection.
Zdravljenje z zdravilom Norvir mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužb z virusom HIV.
When the enzyme is blocked, the virus does not reproduce normally, slowing down its rate of multiplication.
Ko je encim zavrt, se virus ne razmnožuje več normalno, temveč upočasnjeno.
Norvir can be used as a ‘‘pharmacokinetic enhancer' (booster' to increase the blood levels of other antiviral medicines that belong to the same group as Norvir (protease inhibitors) called amprenavir, atazanavir, fosamprenavir, lopinavir, saquinavir, tipranavir and darunavir.
Zdravilo Norvir se uporablja kot „farmakokinetični stopnjevalec“, ki v krvi povečuje raven drugih protivirusnih zdravil iz iste skupine kot zdravilo Norvir (zaviralci proteaz), tj. amprenavir, atazanavir, fosamprenavir, lopinavir, sakvinavir, tipranavir in darunavir.
Norvir is a medicine that contains the active substance ritonavir.
Norvir je zdravilo, ki vsebuje zdravilno učinkovino ritonavir.
In the second study, patients taking Norvir had greater reductions in viral load and increases in CD4 cell counts than those taking zidovudine alone.
V drugi študiji je pri bolnikih, ki so prejemali zdravilo Norvir, prišlo do večjega znižanja virusnega bremena in povečanja števila celic CD4 kot pri tistih, ki so jemali le zidovudin.
What is the risk associated with Norvir?
Kakšna tveganja so povezana z zdravilom Norvir?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Norvir, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
CD4 T cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
T-celice CD4 so bele krvničke, ki imajo pomembno vlogo pri premagovanju okužb, vendarjih virus HIV uničuje.
Norvir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Zdravilo Norvir v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusa HIV v krvi in jo zadržuje na nizki ravni.
The effects of Norvir as an antiviral medicine in combination with other antiviral medicines were also studied in four studies of children.
Učinke zdravila Norvir kot protivirusnega zdravila v kombinaciji z drugimi protivirusnimi zdravili so raziskovali tudi v štirih študijah pri otrocih.
Norvir must not be used in patients who have severe problems with their liver or patients who are taking St John's wort (a herbal preparation used to treat depression) or medicines that are broken down in the same way as Norvir and are harmful at high levels in the blood.
Zdravila ne smejo uporabljati bolniki z resnim obolenjem jeter ali tisti, ki se zdravijo s šentjanževko (rastlinskim pripravkom za zdravljenje depresije) ali zdravili, ki se presnavljajo enako kot zdravilo Norvir in so pri visokih koncentracijah v krvi škodljiva.
The combination of Norvir and zidovudine was less effective than Norvir alone, although the reasons for this were unclear.
Kombinacija zdravil Norvir in zidovudin ni bila tako učinkovita kot zdravilo Norvir, uporabljeno kot samostojno zdravilo, čeprav razlogi za to niso jasni.
Information on these studies can be found in the EPAR summaries for the other medicines.
Informacije o teh študijah so na voljo v evropskih javnih poročilih o oceni zdravila (EPAR) za omenjena zdravila.
At higher doses, ritonavir acts as a ‘protease inhibitor'.
Ritonavir pri večjih odmerkih deluje kot „zaviralec proteaze“.
Norvir has been studied as a booster in clinical studies that were designed to assess the effects of the antiviral medicines that it is used to boost.
Delovanje zdravila Norvir kot stopnjevalca je bilo raziskano v kliničnih študijah, ki so bile zasnovane za oceno učinkov protivirusnih zdravil, katerih učinek se spodbuja z zdravilom Norvir.
Why has Norvir been approved?
Zakaj je bilo zdravilo Norvir odobreno?
Norvir can also be used as an HIV medicine, where it acts directly against the virus.
Zdravilo Norvir se lahko uporablja tudi za zdravljenje okužbe z virusom HIV, pri čemer deluje neposredno na viruse.
For the full list of all restrictions and side effects reported with Norvir, see the package leaflet.
Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila Norvir, glejte navodilo za uporabo.
When the active substance, ritonavir, acts as a ‘booster' it does so by slowing down the rate at which certain antiviral medicines given in combination with ritonavir are broken down in the body.
Ko zdravilna učinkovina v zdravilu Norvir, ritonavir, deluje kot farmakokinetični stopnjevalec, v telesu upočasnjuje razgradnjo nekaterih protivirusnih zdravil, dajanih v kombinaciji z ritonavirjem.
The first compared Norvir with placebo (a dummy treatment) in 1,090 adults, as an add-on to the antiviral medicines the patients were already taking.
V prvi študiji so pri 1 090 odraslih zdravilo Norvir primerjali s placebom (zdravilom brez zdravilne učinkovine), dajali pa so ju kot dodatek drugim protivirusnim zdravilom, ki so jih bolniki že jemali.
Norvir, in combination with other antiviral medicines, also reduced viral loads in children.
Zdravilo Norvir lahko v kombinaciji z drugimi protivirusnimi zdravili zmanjša virusno breme tudi pri otrocih.
How does Norvir work?
Kako zdravilo Norvir deluje?
How has Norvir been studied?
Kako je bilo zdravilo Norvir raziskano?
What is Norvir used for?
Za kaj se zdravilo Norvir uporablja?
See the package leaflet provided with the other medicine for full details.
Za podrobne informacije glejte navodilo za uporabo, priloženo drugemu zdravilu.
The standard dose for adults is 100 or 200 mg, once or twice a day.
Običajni odmerek za odrasle je 100 ali 200 mg enkrat ali dvakrat na dan. Odmerek je odvisen od drugega zaviralca proteaz, ki ga bolnik jemlje.
When it is used as a booster, the side effects of Norvir depend on the other antiviral medicine being taken.
Če bolnik zdravilo Norvir uporablja kot stopnjevalec, so neželeni učinki odvisni od drugih protivirusnih zdravil, ki jih bolnik jemlje.
The second study compared Norvir taken alone, zidovudine (another antiviral medicine) taken alone and the combination of Norvir and zidovudine in 356 adults who had not taken treatment for HIV infection before.
V drugi študiji so pri 356 bolnikih, ki se pred tem zaradi okužbe z virusom HIV še niso zdravili, primerjali jemanje zgolj zdravila Norvir, jemanje zgolj zidovudina (drugega protivirusnega zdravila) in kombinacijo zdravila Norvir ter zidovudina.
What is Norvir?
Kaj je zdravilo Norvir?
How is Norvir used?
Kako se zdravilo Norvir uporablja?
Some medicines cannot be taken with Norvir when it is used in this way.
Kadar se zdravilo Norvir uporablja v ta namen, nekaterih drugih zdravil ni dovoljeno jemati.
Vial (glass)
Viala (steklo) 2ml
Invented name Strength Pharmaceutical form
Farmacevtska oblika Pot uporabe Ovojnina Vsebina (koncentracija) Velikost pakiranje
MA (EU) number (Invented)
Številka MA (EU) (Izmišljeno) ime Jakost
The Board adopted the decision with two votes against.
Odbor je odločitev sprejel z dvema glasovoma proti.
The document should be agreed in two weeks' time.
Dokument naj bi bil dokončan v dveh tednih.
The European Parliament Budget Control Committee received the proposal to postpone the discharge for the financial year 2009 for the Agency, although both the European Parliament Committee on the Environment, Public Health and Food Safety and the European Court of Auditors recommended the discharge.
Odbor Evropskega parlamenta za proračunski nadzor je prejel predlog za odložitev podelitve razrešnice agenciji za finančno leto 2009, čeprav sta tako Odbor Evropskega parlamenta za okolje, javno zdravje in varnost hrane kot Evropsko računsko sodišče priporočila sprejetje razrešnice.
Therefore we cannot give our approval for current activities of Thomas Lönngren."
Zato ne moremo odobriti sedanjih dejavnosti Thomasa Lönngrena.“
During the period from 25 November 2010 to 15 March 2011, the Board finalised eight written procedures.
V obdobju od 25. novembra 2010 do 15. marca 2011 je odbor zaključil osem pisnih postopkov.
The provisional draft budget (PDB) 2012 amounts to EUR 238.4 million, representing an increase of EUR 29.5 million over the 2011 budget.
Začasni predlog proračuna za leto 2012 znaša 238,4 milijona EUR, kar v primerjavi s proračunom za leto 2011 pomeni povečanje za 29,5 milijona EUR.
Information on the Agency's cooperation with the World Organisation for Animal Health (OIE) will also be added.
Dodani bodo tudi podatki o sodelovanju agencije s Svetovno organizacijo za zdravje živali (OIE).
In the field of IT, a more strategic approach with clear prioritisation is called for.
Na področju IT pa je potreben bolj strateški pristop z jasno opredeljenimi prednostnimi nalogami.
The total staffing needed for the full implementation of the legislation (phased over five years) may be higher.
Skupno število zaposlenih, potrebnih za celovito izvajanje zakonodaje (postopno v naslednjih petih letih), je lahko večje.
The reason for the delays will need to be clarified over time.
Sčasoma bo treba te zamude pojasniti.
The Acting Executive Director met with Commissioner Dalli on 11 March 2011.
Vršilec dolžnosti izvršnega direktorja se je 11. marca 2011 sestal s komisarjem Dallijem.
The full annual report will be submitted to the Board in May 2011 for adoption at the June 2011 meeting.
Celotno letno poročilo bo upravnemu odboru predloženo maja 2011 za sprejetje na seji junija 2011.
• Presentation: Project 2014; Update to the Management Board.
• Predstavitev: Projekt 2014; posodobitev za upravni odbor.
However, the Agency expects that the Budgetary Authority will grant some posts later this year.
Vendar pa agencija pričakuje, da bo proračunski organ odobril nekatera delovna mesta kasneje v letošnjem letu.
The document follows the revised rules laid down by the European Commission.
Dokument je usklajen s spremenjenimi pravili, ki jih je določila Evropska komisija.
• Road map to 2015.
• Časovni načrt do leta 2015
The report identified areas where some delays occurred.
V poročilu so navedena tudi področja, na katerih je prišlo do zamud.
Declarations of conflicts of interests
Izjave o navzkrižju interesov
Meeting with Commissioner Dalli
Srečanje s komisionarjem Dallijem
They discussed a number of topics pertinent to the Agency.
Govorila sta o številnih temah v zvezi z agencijo.
1 Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP).
1 Odbor za zdravila za uporabo v humani medicini (CHMP) ali Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
The Board stressed its role in protecting the public interest and the reputation of the Agency.
Odbor je poudaril svojo vlogo pri varovanju javnega interesa in ugleda agencije.
Members regretted the late notification by Mr Lönngren of details of his activities.
Člani so izrazili obžalovanje zaradi poznega obvestila Thomasa Lönngrena o podrobnostih njegovega delovanja.
• The task force on the availability of medicines, which has completed its mandate.
• delovna skupina za razpoložljivost zdravil, ki je zaključila mandat;
The European Commission has initiated a review of the Fee Regulation.
Evropska komisija je sprožila pregled uredbe o pristojbinah.
• Report from BNP Paribas Real Estate.
• Poročilo nepremičninske družbe BNP Paribas Real Estate.