natgillin/translations-raw huggingface dataset:
Both studies showed that Vaxelis produces satisfactory levels of antibodies to protect against all of these six diseases in between 90 and 100% of children who completed the course of vaccination with Vaxelis.
Obe študiji sta pokazali, da cepivo Vaxelis sproži nastajanje protiteles v zadostni koncentraciji, da pred vsemi šestimi boleznimi zaščiti od 90 do 100 % otrok, ki so zaključili cepljenje s cepivom Vaxelis.
What are the risks associated with Vaxelis?
Kakšna tveganja so povezana s cepivom Vaxelis?
In these studies, children also received other vaccines according to local vaccination schedules to protect against other childhood diseases such as rotavirus gastroenteritis, measles, mumps, rubella and varicella.
V teh študijah so otroci prejeli tudi druga cepiva v skladu z lokalnimi programi cepljenja za zaščito pred drugimi otroškimi boleznimi, kot so rotavirus gastroenteritis, ošpice, mumps, rdečke in norice.
The effects of Vaxelis were compared with those of another vaccine, Infanrix hexa, designed to protect against the same six diseases as Vaxelis.
Učinke cepiva Vaxelis so primerjali z učinki drugega cepiva, Infanrix hexa, ki ščiti pred istimi šestimi boleznimi kot cepivo Vaxelis.
When a child is given the vaccine, the immune system recognises the materials from the bacteria and viruses as foreign and makes antibodies against them.
Ko otrok prejme cepivo, imunski sistem prepozna snovi bakterij in virusov kot tujek in proti njim razvije protitelesa.
What is Vaxelis and what is it used for?
Kaj je cepivo Vaxelis in za kaj se uporablja?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vaxelis, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Vaxelis in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For practical information about using Vaxelis, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi cepiva Vaxelis naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
For the full list of all side effects reported with Vaxelis, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri cepivu Vaxelis, glejte navodilo za uporabo.
It must not be used in children who have ever had encephalopathy (a brain disease) of unknown cause within seven days of receiving a vaccine containing pertussis components.
Ne sme se uporabljati pri otrocih, ki so v preteklosti preboleli encefalopatijo (obolenje možganov) neznanega vzroka v sedmih dneh po predhodnem odmerku cepiva proti oslovskemu kašlju.
This means that some of the active substances are fixed onto minute particles of aluminium compounds.
To pomeni, da je nekaj zdravilne učinkovine pritrjene na majhne delce aluminijevih spojin.
For more information about treatment with Vaxelis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju s cepivom Vaxelis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
• tetanus (lockjaw, usually caused by infection of a wound);
• tetanusom (mrtvičnim krčem, ki ga navadno povzroči okužba rane);
The most common side effects with Vaxelis include pain, swelling and redness at the site of injection, irritability, crying, sleepiness, fever, reduced appetite and vomiting.
Najpogostejši neželeni učinki cepiva Vaxelis vključujejo bolečino, otekanje in rdečico na mestu injiciranja, razdražljivost, jok, zaspanost, povišano telesno temperaturo, zmanjšan tek in bruhanje.
• poliomyelitis (polio, a disease that affects the nerves and can lead to muscle weakness or paralysis);
• otroško paralizo (boleznijo, ki prizadene živce in lahko povzroči oslabelost mišic ali paralizo);
Why is Vaxelis approved?
Zakaj je bilo cepivo Vaxelis odobreno?
Vaxelis is available in pre-filled syringes as a suspension for injection.
Cepivo Vaxelis je na voljo v obliki suspenzije za injiciranje v napolnjenih injekcijskih brizgah.
The immune system will then be able to produce antibodies quickly when the person is naturally exposed to the bacteria or viruses.
Posledično bo imunski sistem ob naravni izpostavitvi bakterijam ali virusom sposoben hitreje tvoriti protitelesa.
They then received a booster dose shortly after their first birthday.
Malo pred tretjim rojstnim dnem so prejeli še obnovitveni odmerek.
The Committee considered that Vaxelis has been shown to produce satisfactory antibody levels against diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses and Hib.
Ugotovil je, da je bilo dokazano, da cepivo Vaxelis ustvari zadostne ravni protiteles proti davici, tetanusu, oslovskemu kašlju, virusu hepatitisa B, poliovirusom in Hib.
Vaxelis is a vaccine containing active substances derived from diphtheria, tetanus, pertussis and Haemophilus influenzae type-b bacteria, the hepatitis B virus, and inactivated polioviruses.
Vaxelis je cepivo, ki vsebuje zdravilne učinkovine, pridobljene iz bakterij davice, tetanusa, oslovskega kašlja in Haemophilus influenzae tipa b, virusa hepatitisa B in inaktiviranih poliovirusov.
The main measure of effectiveness was the production of antibody levels known to be protective against diphtheria, tetanus, poliomyelitis, hepatitis B and H. influenzae type b infections and expected to protect against pertussis.
Glavno merilo učinkovitosti je bila tvorba protiteles v koncentraciji, ki znano ščiti pred davico, tetanusom, otroški paralizi, hepatitisom B in okužbam s H. influenzae tipa b, in ki po pričakovanju ščiti pred oslovskim kašljem.
How is Vaxelis used?
Kako se cepivo Vaxelis uporablja?
How does Vaxelis work?
Kako cepivo Vaxelis deluje?
Vaxelis is a vaccine.
Zdravilo Vaxelis je cepivo.
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)
Vaxelis konjugirano (adsorbirano) cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno, komponentno), hepatitisu B (rekombinantno), otroški paralizi (inaktivirano) in bakteriji Haemophilus tipa b
• pertussis (whooping cough);
• oslovskim kašljem;
The European Commission issued a decision on 14 June 2010.
Evropska komisija je odločbo izdala dne 14. junija 2010.
It was used in combination with an appropriate diet.
Uporabljal se je v kombinaciji z ustrezno dieto.
14 June 2010
14. julij 2010
The review was carried out under an ‘Article 107' procedure1.
Pregled je bil izveden v skladu s postopkom iz člena 1071.
Prof. Philippe Lechat (France)
prof. Philippe Lechat (Francija)
Prof. Cristina Sampaio (Portugal)
prof. Cristina Sampaio (Portugalska)
What are the recommendations for patients and prescribers?
Kakšna so priporočila za bolnike in zdravnike, ki zdravila predpisujejo?
• Doctors should stop prescribing benfluorex.
• Zdravniki morajo prenehati predpisovati benfluoreks.
What is benfluorex?
Kaj je benfluoreks?
This has been known to make patients feel less hungry (appetite suppressant).
To dokazano zmanjša občutek lakote pri bolnikih (zaviralec apetita).
• Patients who have been treated with these medicines in the past should mention this to their doctor, who will look for the signs and symptoms of heart valve disease.
• Bolniki, ki so se zdravili s temi zdravili v preteklosti, morajo to omeniti svojemu zdravniku, ki jih bo pregledal za znake in simptome bolezni srčnih zaklopk.
Questions and answers on the withdrawal of medicines containing benfluorex EMA/811097/2009 Rev. 1
Vprašanja in odgovori v zvezi z umikom zdravil, ki vsebujejo benfluoreks EMA/811097/2009 Rev. 1
In addition, there is risk of valve diseases with the use of benfluorex, which was confirmed in a new study conducted in October 2009.
Poleg tega pri jemanju benfluoreksa obstaja tveganje bolezni srčnih zaklopk, kar potrjuje nova študija, opravljena oktobra leta 2009.
The European Medicines Agency has completed a review of the safety and effectiveness of benfluorex.
Evropska agencija za zdravila je zaključila pregled varnosti in učinkovitosti benfluoreksa.
Questions and answers on the withdrawal of medicines containing benfluorex
Vprašanja in odgovori v zvezi z umikom zdravil, ki vsebujejo benfluoreks
Medicines containing benfluorex were first authorised in 1974.
Zdravila, ki vsebujejo benfluoreks, so bila prvič odobrena leta 1974.
It also has an effect on the liver by increasing the production of glycogen (the storage form of glucose in the liver).
Učinkuje tudi na jetra, tako da poveča nastajanje glikogena (oblika shranjevanja glukoze v jetrih).
2 Benfluorex-containing products are also authorised but not marketed in Cyprus and Luxemburg.
2 Zdravila, ki vsebujejo benfluoreks, so odobrena tudi na Cipru in v Luksemburgu, vendar niso v prometu.
Why was benfluorex reviewed?
Zakaj je bil benfluoreks pregledan?
• Patients who have any questions should speak to their doctor or pharmacist.
• Bolniki se lahko z vprašanji obrnejo na svojega zdravnika ali farmacevta.
The review included information provided by the market leader from clinical trials, information published in scientific journals, and ‘spontaneous reports' of side effects from patients to the companies that make the medicines or health authorities.
Pregled je zajemal tudi podatke iz kliničnih preskušanj, ki jih je predložila vodilna družba na tržišču, podatke, objavljene v znanstvenih revijah, in „spontana poročila“ o neželenih učinkih, ki so jih bolniki sporočili družbam, ki izdelujejo zdravila, ali zdravstvenim organom.
In 2007, a re-assessment of the benefit-risk balance led to the withdrawal of the indication for the use in patients with high blood levels of triglycerides, a type of fat.
Leta 2007 je ponovna ocena razmerja med koristmi in tveganji povzročila umik indikacije uporaba pri bolnikih z visokimi ravnmi trigliceridov (vrste maščobe) v krvi.
As required by Article 107, the French authority informed the CHMP of its action so that the Committee could prepare an opinion on whether the marketing authorisations for products containing benfluorex should be maintained, changed, suspended or revoked across the EU.
Skladno z določili člena 107 je francoski pristojni organ obvestil CHMP o svojih ukrepih, da bi Odbor lahko oblikoval mnenje v zvezi s tem, ali naj se dovoljenja za promet z zdravili, ki vsebujejo benfluoreks, v EU ohranijo, spremenijo, začasno umaknejo ali prekličejo.
Shortly after, as a precautionary measure, the Portuguese medicines regulatory authority also decided to recall these medicines from the market.
Kmalu zatem se je tudi portugalski regulativni organ za zdravila odločil, da kot previdnostni ukrep ta zdravila umakne iz prometa.
Benfluorex works by making the cells more sensitive to insulin, which means that the body makes better use of the insulin it produces and the blood glucose is reduced.
Benfluoreks deluje tako, da poveča občutljivost celic za insulin, kar pomeni, da telo bolje izkoristi lastni insulin, to pa zniža raven glukoze v krvi.
In November 2009, following several reports of cardiac valvulopathy (thickening of the heart valves) and pulmonary arterial hypertension (high blood pressure in the artery that leads from the heart to the lungs), the French medicines regulatory authority carried out a review of the safety of benfluorex and decided to suspend its marketing authorisation.
Novembra leta 2009 je francoski regulativni organ za zdravila po več prijavah srčne valvulopatije (odebelitve srčnih zaklopk) in pljučne arterijske hipertenzije (visokega krvnega tlaka v arteriji, ki vodi od srca do pljuč) opravil pregled varnosti benfluoreksa in se odločil začasno umakniti njegovo dovoljenje za promet.
The CHMP has reviewed available information on the safety and efficacy of benfluorex-containing medicines, particularly data on the associated risk of heart valve diseases and pulmonary arterial hypertension.
CHMP je pregledal razpoložljive podatke o varnosti in učinkovitosti zdravil, ki vsebujejo benfluoreks, zlasti podatke o povezanih tveganjih za bolezni srčnih zaklopk in pljučno arterijsko hipertenzijo.
At the time of this review,they were available as tablets containing 150 mg benfluorex hydrochloride in France and Portugal2 under the following invented names, Mediator, Benfluorex Mylan and Benfluorex Qualimed.
V času pregleda so bile v Franciji in na Portugalskem2 na voljo tablete, ki vsebujejo 150 mg benfluoreksijevega klorida, z naslednjimi lastniškimi imeni: Mediator, Benfluorex Mylan in Benfluorex Qualimed.
The CHMP noted that the available data show that the effect of benfluorex in the treatment of diabetes is only limited.
CHMP je ugotovil, da razpoložljivi podatki kažejo, da je učinek benfluoreksa pri zdravljenju sladkorne bolezni majhen.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of benfluorex no longer outweigh its risks, and that all marketing authorisations for medicines containing benfluorex should be revoked throughout the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi benfluoreksa ne odtehtajo več z njim povezanih tveganj in da je treba dovoljenja za promet z zdravili, ki vsebujejo benfluoreks, preklicati po vsej Evropski uniji (EU).
Company responses provided on:
Odgovori družbe poslani dne:
Therefore, on the basis of the evaluation of these data and the scientific discussion within the Committee, the CHMP concluded that the benefits of benfluorex-containing medicines do not outweigh their risks, and therefore recommended that the marketing authorisation of these medicines be revoked.
CHMP je po oceni teh podatkov in znanstveni razpravi v Odboru menil, da koristi zdravil, ki vsebujejo benfluoreks, ne odtehtajo z njimi povezanih tveganj, zato je priporočil preklic dovoljenja za promet s temi zdravili.
Since its marketing authorisation, the safety of benfluorex has been reviewed several times.
Od prve odobritve dovoljenja za promet z benfluoreksom je bila njegova varnost večkrat pregledana.
Benfluorex was used as an add-on treatment in patients with diabetes who are overweight.
Benfluoreks se je uporabljal kot dodatno zdravljenje pri bolnikih s sladkorno boleznijo in prekomerno telesno težo.
based on each patient's symptoms and risk profile.
Uporabiti je treba ustrezne alternativne načine zdravljenja glede na bolnikove simptome in profil tveganja.
As a result, benfluorex-containing medicines were taken off the market in France.
vsa zdravila, ki vsebujejo benfluoreks, v Franciji umaknjena iz prometa.
• Patients who are currently treated with benfluorex-containing medicines should, when convenient,
• Bolniki, ki se trenutno zdravijo z zdravili, ki vsebujejo benfluoreks, morajo ob naslednji priložnosti obiskati zdravnika, da bo spremenil njihov recept.
on 2 May 2007.
dne 2. maja 2007.
This summary was last updated in 06-2010.
Povzetek je bil nazadnje posodobljen 06-2010.
As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 12 August 2010.
Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 12. avgusta 2010.
This helps to protect against the disease.
To pomaga pri obrambi pred boleznijo.
A second dose may be given after an interval of at least three weeks.
Drugi odmerek lahko sledi po vsaj treh tednih.
In children aged from six to 35 months of age, the use of a second dose has been shown to increase the immune response.
Pri otrocih, starih od šest do 35 mesecev, je bilo dokazano, da uporaba drugega odmerka poveča imunski odziv.
The virus has been first inactivated (killed) so that it does not cause any disease.
Virus je bil naprej inaktiviran (uničen), tako da ne povzroča bolezni.
The marketing authorisation is valid for five years, after which it can be renewed.
Dovoljenje za promet z zdravilom velja pet let, nato ga je mogoče podaljšati.
Focetria was originally authorised under ‘exceptional circumstances', because, for scientific reasons, limited information was available at the time of approval.
Zdravilo Focetria je bilo prvotno odobreno v „izjemnih okoliščinah“, saj so bile zaradi znanstvenih razlogov ob odobritvi na voljo le omejene informacije.
The outer membranes that contain the surface antigens have then been extracted and purified.
Zunanje membrane, ki vsebujejo površinske antigene, so bile nato izločene in prečiščene.
The vaccine can only be obtained with a prescription.
Cepivo se dobi samo na recept.
In both studies, the vaccine was shown to bring about protective levels of antibodies to a satisfactory level, in line with the criteria laid down by the CHMP.
V obeh študijah je bilo dokazano, da cepivo povzroči nastanek zadovoljivih zaščitnih ravni protiteles v skladu z merili, ki jih je določil CHMP.
Other information about Focetria:
Druge informacije o zdravilu Focetria:
The CHMP noted that a single dose was able to trigger immunity to a satisfactory level in adults and children and adolescents aged six months to 17 years.
CHMP je poudaril, da je enojni odmerek sprožil imunost na zadovoljivi ravni pri odraslih ter otrocih in mladostnikih, starih od šest mesecev do 17 let.
Focetria is a vaccine.
Zdravilo Focetria je cepivo.
The vaccine also contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Cepivo vsebuje tudi „adjuvans“ (spojino, ki vsebuje olje) za spodbujanje imunskega odziva.
Two main studies have been carried out that looked at the ability of a two-dose schedule of the vaccine to trigger an immune response, one study in 661 healthy adults (including 251 elderly subjects over 60 years of age), and one study in 720 healthy children and adolescents (aged between six months and 17 years).
Izvedeni sta bili dve glavni študiji, v katerih so proučevali sposobnost cepiva, da po shemi dveh odmerkov sproži imunski odziv; v eno študijo je bilo vključenih 661 zdravih odraslih (vključno z 251 starostniki, starejšimi od 60 let), v drugo pa 720 zdravih otrok in mladostnikov (starih od šest mesecev do 17 let).
Focetria should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any substances found at trace (very low) levels in the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), kanamycin or neomycin sulphate (antibiotics), formaldehyde and cetyltrimethylammonium bromide.
Cepivo Focetria se ne sme dajati osebam, ki so imele anafilaktično reakcijo (resno alergijsko reakcijo) na katero koli sestavino cepiva ali na katero koli od snovi, ki jih cepivo vsebuje v sledeh (v zelo nizkih količinah), kot so jajca, piščančje beljakovine, ovalbumin (beljakovina v beljaku), kanamicin ali neomicin sulfat (antibiotika), formaldehid in cetiltrimetilamonijev bromid.
The European Commission granted a marketing authorisation valid throughout the European Union for Focetria to Novartis Vaccines and Diagnostics S.r.l.
Evropska komisija je dovoljenje za promet z zdravilom Focetria, veljavno po vsej Evropski uniji, odobrila podjetju Novartis Vaccines and Diagnostics S.r.l.
The CHMP decided that Focetria's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Focetria večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
This document is a summary of the European Public Assessment Report (EPAR) for Focetria.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Focetria.
The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again.
Imunski sistem bo tako ob ponovni izpostavitvi virusu hitreje tvoril protitelesa.
When a person is given the vaccine, the immune system recognises the virus parts as ‘foreign' and makes antibodies against it.
Ko oseba prejme cepivo, imunski sistem prepozna delce virusa kot „tujek“ in proti njemu tvori protitelesa.
It is a suspension for injection that contains parts (‘surface antigens') of the influenza (flu) virus.
Je suspenzija za injiciranje, ki vsebuje dele (površinske antigene) virusa influence (gripe).
The most common side effects with Focetria (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of the injection (pain, hardening and redness), malaise (feeling unwell), sweating and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Focetria (opaženi pri več kot 1 bolniku od 10) so bili glavobol, mialgija (bolečine v mišicah), reakcije na mestu injiciranja (bolečine, otrdelost in rdečina), slabost (slabo počutje), znojenje, utrujenost in drhtavica.
What benefit has Focetria shown during the studies?
Kakšne koristi je zdravilo Focetria izkazalo v študijah?
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 Focetria.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Focetria, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Focetria was originally developed as a pandemic vaccine, to be used during the influenza A (H1N1) pandemic declared in June 2009.
Zdravilo Focetria je bilo prvotno pripravljeno kot pandemsko cepivo, ki naj bi se uporabljalo med pandemijo gripe A(H1N1), razglašeno junija 2009.
In the elderly (over 60 years of age), the second dose must be given.
Ta drugi odmerek morajo prejeti starostniki (starejši od 60 let).
Focetria influenza vaccine (H1N1)v (surface antigen, inactivated, adjuvanted)
Focetria cepivo proti gripi (H1N1) (z delci virionov, inaktivirano, z adjuvansom)
For the full list of all side effects reported with Focetria, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri cepivu Focetria, glejte navodilo za uporabo.
Focetria is given as one dose, injected into the muscle of the shoulder or thigh.
Cepivo Focetria se daje v enkratnem odmerku z injiciranjem v ramensko ali stegensko mišico.
Focetria is given according to official recommendations.
Cepivo se daje le v skladu z uradnimi priporočili.
For more information about treatment with Focetria, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Focetria preberite navodilo za uporabo (ki je prav tako del EPAR).
Why has Focetria been approved?
Zakaj je bilo zdravilo Focetria odobreno?
Focetria is a vaccine to protect against flu caused by the A (H1N1)v 2009 virus.
Zdravilo Focetria je cepivo za zaščito pred gripo, ki jo povzroča virus A (H1N1)v 2009.
What is the risk associated with Focetria?
Kakšna tveganja so povezana z uporabo zdravila Focetria?
It contains a flu strain called A/California/7/2009 (H1N1)-derived strain NYMC X-181.
Vsebuje sev gripe, imenovan sev NYMC X-181, pridobljen iz seva A/California/7/2009 (H1N1).
Focetria contains small amounts of ‘surface antigens' (proteins on the outer membrane of the virus) of a virus called A(H1N1)v 2009.
Zdravilo Focetria vsebuje majhne količine površinskih antigenov (beljakovin na zunanji membrani virusa) virusa A(H1N1)v 2009.
The full EPAR for Focetria can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Focetria je na voljo tukaj.
What is Focetria used for?
Za kaj se zdravilo Focetria uporablja?
How has Focetria been studied?
Kako je bilo zdravilo Focetria raziskano?
What is Focetria?
Kaj je zdravilo Focetria?
How is Focetria used?
Kako se zdravilo Focetria uporablja?
How does Focetria work?
Kako zdravilo Focetria deluje?
The reasons for this are not clear.
Vzroki za to niso povsem jasni.
This summary was last updated in September 2016.
Povzetek je bil nazadnje posodobljen septembra 2016.
Hands should be washed after use.
Po uporabi si je treba umiti roke.