natgillin/translations-raw huggingface dataset:
FEV1 is the maximum volume of air a person can breathe out in one second, while PEF is the maximum speed at which a person can expel air from their lungs.
FEV1 je največji volumen zraka, ki ga lahko posameznik izdihne v eni sekundi, medtem ko je PEF najvišja hitrost, s katero lahko posameznik izdihne zrak iz pljuč.
The primary measures of effectiveness were based on the patients' forced expiratory volumes (FEV1) or peak expiratory flow (PEF) after treatment.
Primarna merila učinkovitosti so temeljila na forsiranih ekspiracijskih volumnih (FEV1) bolnikov ali največjem pretoku zraka med izdihom (PEF) po zdravljenju.
After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 27 June 2013.
Po proučitvi podlage za to zahtevo je CHMP ponovno pregledal prvotno mnenje in dne 27. junija 2013 potrdil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom.
On 21 March 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Labazenit, intended for the treatment of asthma.
Odbor za zdravila za uporabo v humani medicini (CHMP) je dne 21. marca 2013 sprejel negativno mnenje, s katerim je priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Labazenit, namenjenim zdravljenju astme.
The two active substances in Labazenit are well known and are present in several medicines used to treat asthma, either alone or in combination with other medicines.
Zdravilni učinkovini v zdravilu Labazenit sta dobro znani in sta prisotni v več zdravilih, ki se bodisi samostojno bodisi v kombinaciji z drugimi zdravili uporabljajo za zdravljenje astme.
The company informed the CHMP that there were no ongoing clinical trials with Labazenit in Europe at the time of the CHMP's opinion.
Družba je CHMP obvestila, da v času izdaje mnenja v Evropi niso potekala nobena klinična preskušanja z zdravilom Labazenit.
Salmeterol is a long-acting beta-2 agonist and it works by attaching to receptors known as beta-2 receptors found in the muscles of the airways.
Salmeterol je dolgodelujoč agonist beta-2, ki deluje tako, da se veže na receptorje, imenovane receptorji beta-2, ki se nahajajo v dihalnih mišicah.
The company presented results of two main studies that compared Labazenit with salmeterol alone in a total of 83 asthma patients, and one main study comparing Labazenit with budesonide alone in 375 patients.
Družba je predložila rezultate dveh glavnih študij s skupno 83 bolniki z astmo, v katerih so zdravilo Labazenit primerjali s samim salmeterolom, in ene glavne študije s 375 bolniki, v kateri so zdravilo Labazenit primerjali s samim budezonidom.
Budesonide is a corticosteroid that works as an anti-inflammatory agent.
Budezonid je kortikosteroid, ki deluje protivnetno.
In addition, data from another study indicated that lower amounts of budesonide may reach the lungs when Labazenit is used.
Poleg tega so podatki iz druge študije pokazali, da lahko pri uporabi zdravila Labazenit pljuča dosežejo manjše količine budezonida.
It was to be available as capsules containing powder for inhalation.
Na voljo naj bi bilo v obliki kapsul s praškom za vdihavanje.
The CHMP's main concern was that the study comparing Labazenit with budesonide alone did not prove that the anti-inflammatory effect of Labazenit was sufficient.
Glavni zadržek odbora CHMP je bil, da študija primerjave zdravila Labazenit s samim budezonidom ni potrdila zadovoljivega protivnetnega učinka zdravila Labazenit.
The CHMP therefore concluded that the benefits of the medicine had not been shown to outweigh its risks and recommended that it be refused marketing authorisation.
CHMP je zato zaključil, da koristi zdravila Labazenit niso večje od z njim povezanih tveganj, in priporočil zavrnitev vloge za pridobitev dovoljenja za promet z njim.
When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Z vezavo na omenjene receptorje povzroči, da se mišice sprostijo, s čimer odpre dihalne poti in bolniku olajša dihanje.
Two larger supportive studies involving 601 patients were also conducted, comparing Labazenit with other corticosteroid-beta-2 agonist combination treatments.
Izvedeni sta bili tudi dve obsežnejši podporni študiji s 601 bolnikom, v katerih so zdravilo Labazenit primerjali z drugimi zdravili s kombinacijo kortikosteroida in agonista beta-2.
When inhaled, it reduces inflammation in the airways, thereby helping to keep the patients' airways clear and allowing them to breathe more easily.
Ob vdihavanju zmanjša vnetje dihalnih poti, s čimer pomaga sprostiti dihalne poti bolnikov in jim tako omogoči lažje dihanje.
Labazenit was expected to be used in the treatment of asthma in adults for whom a combination product containing an inhaled corticosteroid and long-acting beta-2 agonist is required.
Zdravilo Labazenit naj bi se uporabljalo za zdravljenje astme pri odraslih, ki potrebujejo kombinirano zdravilo, ki vsebuje inhalacijski kortikosteroid in dolgodelujoč agonist beta-2.
What is Labazenit?
Kaj je zdravilo Labazenit?
What was Labazenit expected to be used for?
Za kaj naj bi se zdravilo Labazenit uporabljalo?
Labazenit is a medicine that contains the active substances budesonide and salmeterol.
Labazenit je zdravilo, ki vsebuje zdravilni učinkovini budezonid in salmeterol.
How is Labazenit expected to work?
Kako naj bi zdravilo Labazenit delovalo?
Date of first authorisation: 06 April 2006 Date of latest renewal: 16 December 2015
Datum prve odobritve: 06. april 2006 Datum zadnjega podaljšanja: 16. december 2015
North Carolina 27712 U.S.A.
North Carolina 27712 ZDA
Several adverse events were solicited in the clinical studies and are designated with the symbol (
Posamezni neželeni dogodki, o katerih v kliničnih študijah niso poročali spontano, so označeni s simbolom(
Concomitant use with other vaccines:
Sočasna uporaba z drugimi cepivi:
The antibodies help protect against diseases caused by these viruses.
Protitelesa pomagajo ščititi pred boleznimi, ki jih povzročajo ti virusi.
* See section c c. Description of selected adverse reactions
* Glejte poglavje c c. Opis izbranih neželenih učinkov
• An allergic reaction to eggs or anything that contained egg.
• Alergijska reakcija na jajca ali na karkoli, kar vsebuje jajca.
Children in these studies were monitored for six weeks post vaccination.
Otroke so v teh študijah spremljali šest tednov po cepljenju.
• Individuals with a lowered resistance to diseases.
• Osebami z zmanjšano odpornostjo proti boleznim.
The appropriate time and number of injections will be determined by your doctor in accordance with official recommendations.
Primeren čas cepljenja in število odmerkov bo določil zdravnik v skladu z uradnimi priporočili.
Even in older women (35 to 45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
Tudi starejše ženske (stare 35 do 45 let) te neželene učinke večinoma dobro prenašajo in le redko jih motijo pri običajnih dejavnostih.
The frequency of these adverse events is qualified as "not known" when it cannot be estimated based on the available data.
Pogostnost teh neželenih učinkov je opredeljena kot "neznana", ko pogostnosti iz razpoložljivih podatkov ni mogoče oceniti.
These data were confirmed by a post-marketing observational study sponsored by the U.S. Centers for Disease Control and Prevention.
Te podatke so potrdili v postmarketinški opazovalni študiji, sponzorirani s strani Centrov za nadzor in preprečevanje bolezni
• Individuals less than 9 months of age
• Posamezniki, mlajši od 9 mesecev
d. Other special populations
d. Druge posebne skupine
The vaccine may contain traces of recombinant human albumin (rHA).
To cepivo lahko v sledeh vsebuje rekombinantni humani albumin (rHA).
Social circumstances Activities of daily living impaired
Socialne okoliščine motene vsakodnevne dejavnosti redki
It is important to use a separate sterile syringe and needle for each individual to prevent transmission of infectious agents from one individual to another.
Pomembno je, da za vsakogar uporabite drugo sterilno brizgo in iglo, da preprečite prenos okužb z enega posameznika na drugega.
Tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines (or other vaccines).
Obvestite zdravnika ali farmacevta, če vi ali vaš otrok jemljete ali ste pred kratkim jemali katero koli drugo zdravilo (ali drugo cepivo).
The safety and efficacy of ProQuad in children under 9 months of age have not been established.
Varnost in učinkovitost cepiva ProQuad pri otrocih, mlajših od 9 mesecev, nista bili dokazani.
Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Not known (cannot be estimated from the available data)
Zelo pogosti ( 1/10), pogosti ( 1/100, < 1/10), občasni ( 1/1.000, < 1/100), redki ( 1/10.000, < 1/1.000); neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed.
Z ovrednotenjem serološkega statusa bolnika se lahko ugotovi, ali so potrebni dodatni odmerki cepiva ali ne.
• If the person to be vaccinated has active untreated tuberculosis.
• Če ima oseba, ki naj bi bila cepljena, aktivno nezdravljeno tuberkulozo.
• An infection with Human Immunodeficiency Virus (HIV) without showing symptoms of HIV disease.
• Okužba s človeškim virusom imunske pomanjkljivosti (HIV) brez znakov bolezni HIV.
Vaccination should be postponed during any illness with fever >38.5C.
Cepljenje je treba odložiti pri kateri koli bolezni z zvišano telesno temperaturo > 38,5 C.
The safety profile post-dose 1 and 2 was generally comparable for all age cohorts.
Profil varnosti po 1. in 2. odmerku je bil na splošno primerljiv za vse starostne skupine.
Reconstitution instructions intended for medical and healthcare professionals are included at the end of the leaflet
Navodila za pripravo, namenjena zdravstvenemu osebju, so navedena na koncu navodila.
See also section 3 How to use ProQuad.
Glejte tudi poglavje 3 Kako uporabljati cepivo ProQuad.
Pharmacotherapeutic group: Vaccines, Viral Vaccine; ATC code: J07BD54.
Farmakoterapevtska skupina: cepiva, virusna cepiva; oznaka ATC: J07BD54.
Investigations Weight loss
Preiskave izguba teže redki
Tell the doctor if your child has recently received a vaccine or if one is scheduled to be given in the near future.
Zdravniku povejte, če je bil vaš otrok pred kratkim cepljen ali če naj bi bil cepljen v bližnji prihodnosti.
Current immunosuppressive therapy (including high doses of corticosteroids) (see section 4.8).
Trenutno imunosupresivno zdravljenje (vključno z velikimi odmerki kortikosteroidov) (glejte poglavje 4.8).
Allergic reactions (hives) may occur.
Lahko se pojavijo alergijske reakcije (koprivnica).
If you or your child have an allergic reaction, call your doctor right away.
Če imate vi ali vaš otrok alergijsko reakcijo, se takoj posvetujte z zdravnikom.
However, vaccination may be less effective than for uninfected persons (see Do not use ProQuad).
Cepljenje je namreč lahko manj učinkovito kot pri neokuženih osebah (glejte S cepivom ProQuad se ne sme cepiti).
There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals.
Ni potrjenih dokazov, ki bi kazali, da se tak virus prenaša na za rdečke dovzetne osebe, ki so v stiku s cepljenimi posamezniki.
• If the person to be vaccinated is allergic to any of the components of this vaccine (including neomycin or any of the other ingredients listed in section 6).
• Če je oseba, ki naj bi bila cepljena, alergična na katero koli sestavino tega cepiva (vključno z neomicinom ali katero koli drugo sestavino, navedeno v poglavju 6).
• If the person to be vaccinated has a blood disorder or any type of cancer that affects the immune system.
• Če ima oseba, ki naj bi bila cepljena, bolezen krvi ali katero koli vrsto raka, ki vpliva na imunski sistem.
Traditional non-clinical studies were not performed, but there are no non-clinical concerns considered relevant to clinical safety beyond data included in other sections of the Summary of Product Characteristics (SmPC).
Običajne predklinične študije varnosti niso bile opravljene, ni pa predkliničnih zadržkov, ki bi jih smatrali za pomembne za klinično varnost, razen podatkov, vključenih v drugih poglavjih Povzetka glavnih značilnosti zdravila (SmPC).
What ProQuad is and what it is used for
Kaj je cepivo ProQuad in za kaj ga uporabljamo
There are insufficient data to support the use of ProQuad with any other vaccines.
Ni dovolj podatkov v podporo uporabi cepiva ProQuad s katerim koli drugim cepivom.
- This vaccine has been prescribed for you or your child only.
- To cepivo je bilo predpisano samo vam ali vašemu otroku in ga ne smete dajati drugim.
Persistence of Immune Response
Trajanje imunskega odziva
In a large case-control study, the vaccine was estimated to be 85% effective against all forms of varicella and 97% effective against moderately severe and severe disease.
V obsežni študiji primerov in kontrol (case-control study) so ocenili, da je cepivo 85 % učinkovito proti vsem oblikam noric ter 97 % učinkovito proti zmerno hudi in hudi bolezni.
What you need to know before you receive ProQuad
Kaj morate vedeti, preden boste prejeli cepivo ProQuad
The safety profiles of the administered vaccines were comparable (see section 4.8).
Varnostni profili prejetih cepiv so bili primerljivi (glejte poglavje 4.8).
No studies on the effects on the ability to drive or use machinery have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja strojev niso izvedli.
• If the person to be vaccinated is pregnant (in addition, pregnancy should be avoided for 1 month after vaccination, see Pregnancy and breast-feeding).
• Če je oseba, ki naj bi bila cepljena, nosečnica (poleg tega 1 mesec po cepljenju ne smete zanositi, glejte Nosečnost in dojenje).
• If the person to be vaccinated is receiving treatment or taking medications that may weaken the immune system (except low-dose corticosteroid therapy for asthma or replacement therapy).
• Če oseba, ki naj bi bila cepljena, prejema terapijo ali jemlje zdravila, ki lahko oslabijo imunski sistem (razen majhnih odmerkov kortikosteroidov pri astmi ali kot nadomestno zdravljenje).
Results showed a gradual decline of varicella rates by an overall 90% to 95% (approximately 10- to 20-fold) from 1995 to 2009 in all age groups, both in vaccinated and unvaccinated children and adolescents.
Rezultati so pokazali postopno upadanje deleža noric za skupno 90 % do 95 % (približno 10- do 20-kratno) od leta 1995 do leta 2009 v vseh starostnih skupinah, tako pri cepljenih kot pri necepljenih otrocih in mladostnikih.
• immunocompromised individuals (see section 4.3),
• osebe s pomanjkljivo imunostjo (glejte poglavje 4.3),
• A history or family history of allergies or of convulsions (fits).
• Družinska anamneza alergij ali konvulzij (krčev).
ProQuad is not indicated in this subset of the paediatric population.
Cepivo ProQuad ni indicirano pri tej podskupini pediatrične populacije.
Following vaccination in children, reactions in joints are generally uncommon (0 to 3%) and of brief duration.
Po cepljenju otrok so neželeni učinki v sklepih večinoma občasni (0 do 3 %) in kratkotrajni.
Observational studies of long-term effectiveness of varicella vaccine Surveillance data from two U.S. observational effectiveness studies confirmed that widespread varicella vaccination reduces the risk of varicella by approximately 90% and that protection is maintained over at least 15 years both in vaccinated and unvaccinated individuals.
Opazovalne študije dolgotrajne učinkovitosti cepiva proti noricam Podatki iz spremljanja v dveh ameriških opazovalnih študijah učinkovitosti so potrdili, da široko cepljenje proti noricam zmanjšuje tveganje za norice za približno 90 %, zaščita pa se ohranja vsaj 15 let tako pri cepljenih kot pri necepljenih posameznikih.
*50% cell culture infectious dose **plaque-forming units
* 50-odstotni infektivni odmerek na celični kulturi (CCID = cell culture infectious dose) ** enote, ki tvorijo plak (PFU = plaque-forming units)
ProQuad is expected to have no or negligible influence on the ability to drive and use machines.
Pri cepivu ProQuad se pričakuje, da nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Over the 10-year observation period, the cumulative rate of varicella was 7.5% after 1 dose and 2.2% after 2 doses.
V 10-letnem obdobju opazovanja je znašal kumulativni delež noric 7,5 % po 1 odmerku in 2,2 % po 2 odmerkih.
In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (12 to 20%), and the reactions tend to be more marked and of longer duration.
Pri ženskah so pojavne stopnje artritisa in artralgije na splošno večje kot pri otrocih (12 do 20 %), neželeni učinki pa so izrazitejši in trajajo dlje časa.
The children in these studies received either the current refrigerator-stable formulation or an earlier formulation of ProQuad.
Otroci so v teh študijah prejeli bodisi obstoječo v hladilniku stabilno obliko cepiva ali predhodno obliko cepiva ProQuad.
ProQuad should be used in accordance to official recommendations.
Cepljenje s cepivom ProQuad je treba izvajati v skladu z uradnimi priporočili.
• If the person to be vaccinated has a weakened immune system because of a disease (including AIDS).
• Če ima oseba, ki naj bi bila cepljena, zaradi bolezni oslabljen imunski sistem (vključno z aidsom).
In addition to assessing the incidence of febrile seizures occurring within 30 days after the first dose (see section 4.8), the study also assessed the general safety of ProQuad in the 30-day period after the first or second dose.
Poleg pojavnosti vročinskih krčev, ki se pojavijo v 30 dneh po prejemu prvega odmerka (glejte poglavje 4.8), so v študiji ovrednotili tudi splošno varnost cepiva ProQuad v obdobju 30 dni po prejemu prvega ali drugega odmerka.
It is not known whether ProQuad can cause foetal harm when administered to a pregnant woman or affect reproduction capacity.
Ni znano, ali lahko cepivo ProQuad škoduje plodu, če z njim cepimo nosečnico, in ali vpliva na sposobnost razmnoževanja.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this vaccine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden boste prejeli to cepivo.
To reconstitute the vaccine, use only the solvent supplied, because it is free of preservatives or other antiviral substances, which might inactivate the vaccine.
Za pripravo cepiva uporabite le priložen vehikel, ker je brez konzervansov ali drugih protivirusnih snovi, ki bi lahko inaktivirale cepivo.
However, in-use stability has been demonstrated for 30 minutes when stored between 20C and 25C.
Bila pa je dokazana 30-minutna stabilnost, kadar se cepivo shranjuje pri temperaturi od 20 C do 25 C.
However, the long term effect of varicella vaccination on the incidence of herpes zoster is unknown at present.
Vendar pa dolgoročni vpliv cepiva proti noricam na pojavnost pasovca trenutno ni znan.
The following other side effects reported with the use of ProQuad were:
Naslednji neželeni učinki, o katerih so tudi poročali pri uporabi cepiva ProQuad, so bili:
CD4+ T-lymphocyte percentage in children below 12 months: CD4+ <25%, children between 12-35 months: CD4+ < 20%; children between 36-59 months: CD4+ < 15% (see sections 4.4 and 4.8).
ali za starost specifični odstotek CD4+ T-limfocitov pri otrocih do 12 mesecev: CD4+ < 25 %; pri otrocih med 12 in 35 meseci: CD4+ < 20 %; pri otrocih med 36 in 59 mesecev: CD4+ < 15 % (glejte poglavji 4.4 in 4.8).
Precautions to be taken before handling or administering the medicinal product: see section 6.6.
Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila: glejte poglavje 6.6.
While the seroconversion rate for varicella was uniformly high (97.9% to 99.8% across all studies), seroconversion has not been shown to correlate well with protection.
Medtem ko je bil delež serokonverzije za norice konstantno visok (97,9 % do 99,8 % v vseh študijah), pa se zanjo ni pokazalo, da bi dobro sovpadala z zaščito.
Both cases were unremarkable and no sequelae were reported.
Oba primera sta bila brez posebnosti in o posledicah niso poročali.
In the 30-day timeframe following vaccination, no increased risk of febrile seizures was observed (see section 5.1).
V obdobju 30 dni po cepljenju niso opazili povečanega tveganja za vročinske krče (glejte poglavje 5.1).
In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and adult women.
Pri dekletih v adolescenci so neželeni učinki po pojavnosti vmes med tistimi pri otrocih in tistimi pri odraslih ženskah.
The persistence of antibody at 1 year after vaccination was evaluated in a subset of 2108 subjects who were involved in 1 clinical trial.
Ohranjanje protiteles 1 leto po cepljenju so ocenjevali pri podskupini 2.108 oseb, ki so sodelovale v enem kliničnem preskušanju.
Formal studies to evaluate the efficacy of ProQuad have not been performed.
Formalne študije za oceno učinkovitosti cepiva ProQuad niso bile izvedene.
There are no long-term data currently available with ProQuad (see section 5.1).
Za cepivo ProQuad dolgoročnejših podatkov trenutno ni na voljo (glejte poglavje 5.1).
Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
Vedno morajo biti na voljo ustrezne možnosti za zdravljenje in nadzor, če bi po cepljenju prišlo do redke anafilaktične reakcije.
The immunogenicity of the current refrigerator-stable formulation was shown to be similar to the immunogenicity of the earlier formulation of ProQuad six weeks after a single dose of the vaccine.
Imunogenost obstoječe oblike stabilne v hladilniku je bila primerljiva z imunogenostjo predhodne oblike cepiva ProQuad šest tednov po enojnem odmerku cepiva.
Vaccine recipients should attempt to avoid, whenever possible, close association with high-risk individuals susceptible to varicella for up to 6 weeks following vaccination.
Cepljene osebe naj bi se, kadar je le mogoče, izogibale tesnemu stiku z osebami z velikim tveganjem, ki so sprejemljive za norice, do 6 tednov po cepljenju.
However, the appropriate suggested interval between transfusion or IG administration and vaccination will vary with the type of transfusion or indication for, and dose of, IG (e.g. 5 months for VZIG).
Ustrezni priporočeni presledek med transfuzijo ali prejemom IG ter cepljenjem se razlikuje glede na vrsto transfuzije ali indikacijo in odmerek IG (npr. 5 mesecev pri VZIG).
Chronic arthritis has been associated with wild-type rubella infection and has been related to persistent virus and/or viral antigen isolated from body tissues.
Kronični artritis so povezovali z okužbo z divjim sevom rdečk in je bil povezan z izolacijo perzistentnega virusa in/ali virusnega antigena iz telesnih tkiv.
Other than the increase in febrile seizure after the first dose, no safety concerns after the first or second dose were identified.
Razen povečanja pojavnosti vročinskih krčev po prvem odmerku niso odkrili nobenih drugih varnostnih zadržkov po prvem ali drugem odmerku.
Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk; however, transmission of the rubella vaccine virus to infants via breast milk has been documented without any evidence of clinical disease (see section 4.6).
Zato se prenos s tesnim osebnim stikom, ki je teoretično možen, ne smatra za pomembno tveganje; dokumentirali pa so prenos cepilnega virusa rdečk na dojenčka z materinim mlekom, brez kliničnih znakov bolezni (glejte poglavje 4.6).
3) Produced in human diploid cells (MRC-5).
3) Pridobljen iz humanih diploidnih celic (MRC-5).