FrancophonIA/ELRC3.0 huggingface dataset:
English: 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 Competact.
Slovenian: 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.
English: Competact contains two active substances which each have a different mode of action.
Slovenian: Zdravilo Competact vsebuje dve zdravilni učinkovini, ki imata različen način delovanja.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Competact, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: 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.
English: The CHMP concluded that the effectiveness of pioglitazone and metformin in type 2 diabetes had been shown, and that Competact simplifies treatment and improves compliance when a combination of the active substances is required.
Slovenian: Odbor CHMP je zaključil, da je bila učinkovitost pioglitazona in metformina pri zdravljenju sladkorne bolezni tipa 2 dokazana in da zdravilo Competact poenostavlja zdravljenje ter izboljšuje zavezanost bolnikov k jemanju zdravila, kadar je potrebna kombinacija zdravilnih učinkovin.
English: At the start of treatment, abdominal pain (stomach ache), diarrhoea, loss of appetite, nausea (feeling sick) and vomiting may occur.
Slovenian: Na začetku zdravljenja se lahko pojavijo bolečine v trebuhu (bolečine v želodcu), driska, izguba teka, slabost in bruhanje.
English: Competact must not be used in patients who have a disease that causes lack of oxygen to the tissues such as a recent heart attack or shock.
Slovenian: Prav tako ga ne smejo uporabljati bolniki z obolenjem, ki povzroča pomanjkanje kisika v tkivih, kot je denimo nedavni srčni napad ali šok.
English: Competact must not be used where there is alcohol intoxication, diabetic ketoacidosis (high levels of ketones), conditions that may effects the kidneys, and during breast-feeding.
Slovenian: Ne sme se uporabljati v primeru alkoholiziranosti, diabetične ketoacidoze (visoke koncentracije ketonov), bolezni, ki utegnejo prizadeti ledvice, in med dojenjem.
English: What is the risk associated with Competact?
Slovenian: Kakšna tveganja so povezana z zdravilom Competact?
English: Pioglitazone on its own has been approved in the EU under the name Actos and can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Slovenian: Pioglitazon kot samostojno zdravilo, ki ga je EU odobrila pod imenom Actos, se lahko uporablja skupaj z metforminom pri bolnikih s sladkorno boleznijo tipa 2, pri katerih zgolj z metforminom ni mogoče doseči zadovoljivega nadzora.
English: Competact must not be used in patients who have heart failure, or problems with their liver or their kidneys.
Slovenian: Zdravila Competact ne smejo jemati bolniki s srčnim popuščanjem ter bolniki, ki imajo težave z jetri ali ledvicami.
English: Why has Competact been approved?
Slovenian: Zakaj je bilo zdravilo Competact odobreno?
English: Competact is used in patients who are not satisfactorily controlled on metformin (a diabetes medicine) used on its own and at the maximum possible dose.
Slovenian: Uporablja se pri bolnikih, pri katerih zgolj z metforminom (zdravilom za zdravljenje sladkorne bolezni), tudi v največjem možnem odmerku, ni mogoče doseči zadovoljivega nadzora.
English: For the full list of side effects reported with Competact, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Competact, glejte navodilo za uporabo.
English: Three studies of Actos used with metformin as separate tablets were used to support the use of Competact in the same indication.
Slovenian: V podporo uporabi zdravila Competact za enako indikacijo so bile uporabljene tri študije zdravila Actos, uporabljenega skupaj z metforminom v obliki ločenih tablet.
English: How has Competact been studied?
Slovenian: Kako je bilo zdravilo Competact raziskano?
English: What is Competact used for?
Slovenian: Za kaj se zdravilo Competact uporablja?
English: How does Competact work?
Slovenian: Kako zdravilo Competact deluje?
English: How is Competact used?
Slovenian: Kako se zdravilo Competact uporablja?
English: What is Competact?
Slovenian: Kaj je zdravilo Competact?
English: August 2015
Slovenian: avgust 2015
English: Adults, including the elderly
Slovenian: Odrasli, vključno s starejšimi osebami
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Slovenian: Natančno preberite navodilo, preden dobite to cepivo, ker vsebuje za vas pomembne podatke!
English: The MAH submitted the data requested above on 5 August 2015 and an opinion was adopted by the CHMP on 28 April 2016.
Slovenian: Imetnik dovoljenja za promet je 5. avgusta 2015 predložil zgoraj zahtevane podatke, mnenje CHMP je bilo sprejeto 28. aprila 2016.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 May 2008
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 20. maj2008
English: These side effects usually disappear within 1-2 days without treatment.
Slovenian: Ti neželeni učinki običajno minejo brez zdravljenja v 1 do 2 dneh.
English: In the first few weeks after vaccination with Pandemrix the results of these tests may not be correct.
Slovenian: V prvih nekaj tednih po cepljenju s cepivom Pandemrix so lahko rezultati teh preiskav napačni.
English: These data suggest that the excessive risk tends to decline with increasing age at vaccination.
Slovenian: Ti podatki kažejo, da se dodatno tveganje zmanjšuje z naraščajočo starostjo ob cepljenju.
English: See sections 4.4, 4.8 and 5.1 for details.
Slovenian: Za podrobnosti glejte poglavja 4.4, 4.8 in 5.1.
English: • Short-term sleepiness following vaccination
Slovenian: • kratkotrajna nespečnost po cepljenju;
English: Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or use machines.
Slovenian: Nekateri učinki, navedeni v poglavju 4.8, "Neželeni učinki", lahko vplivajo na sposobnost vožnje ali upravljanja s stroji.
English: The MAH shall agree with Member States on mechanisms allowing patients and health care professionals to have continuous access to updated information regarding Pandemrix.
Slovenian: Imetnik dovoljenja za promet se bo z državami članicami dogovoril o mehanizmih, ki bodo bolnikom in zdravnikom omogočali stalen dostop do posodobljenih informacij o cepivu Pandemrix.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/452/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/452/001
English: Based on the evaluation of the data submitted, the CHMP considers that the above post-authorisation measures as reflected above have been fulfilled.
Slovenian: Na podlagi ocene predloženih podatkov CHMP meni, da so izpolnjeni vsi zgoraj navedeni ukrepi po pridobitvi dovoljenja za promet.
English: Children aged less than 6 months of age Vaccination is currently not recommended in this age group.
Slovenian: Otroci, mlajši od 6 mesecev Cepljenje v tej starostni skupini trenutno ni priporočeno.
English: Split influenza virus, inactivated, containing antigen* equivalent to:
Slovenian: razcepljen virus influence, inaktiviran, ki vsebuje antigene*, ki ustrezajo:
English: Please see details of the assessment in the CHMP assessment report EMEA/H/C/000832/II/0079 published on the EMA website.
Slovenian: Podrobnosti o oceni so navedene v CHMP poročilu o oceni zdravila EMEA/H/C/000832/II/0079, objavljenem na spletni strani EMA.
English: Vaccination is not recommended in this age group.
Slovenian: V tej starostni skupini cepljenje ni priporočeno.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this vaccine.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da ste noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden dobite to cepivo.
English: Pandemrix should be used in accordance with Official Guidance.
Slovenian: Cepivo Pandemrix je treba uporabljati v skladu z uradnimi priporočili.
English: Loss of appetite
Slovenian: Razdražljivost Izguba apetita
English: In addition, fever was very common in children aged 3-5 years.
Slovenian: Poleg tega je bila pri otrocih v starosti od 3 do 5 let zelo pogosta zvišana telesna temperatura.
English: The dose recommendations take into account the safety and immunogenicity data from clinical studies in healthy subjects
Slovenian: Priporočila za odmerjanje upoštevajo podatke o varnosti in imunugenosti iz kliničnih študij pri zdravih preiskovancih.
English: The MAH shall agree with Member States to measures facilitating the identification and traceability of the A/H1N1 vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions.
Slovenian: Imetnik dovoljenja za promet se bo z državami članicami dogovoril o ukrepih za lažjo identifikacijo in sledljivost cepiva A/H1N1, uporabljenega pri posameznem bolniku, da bi čim bolj zmanjšali napake pri uporabi cepiva ter v pomoč bolnikom in zdravnikom pri poročanju o neželenih učinkih.
English: Information on outcomes from estimated more than 200,000 women who have been vaccinated during pregnancy is currently limited.
Slovenian: Trenutno je malo informacij o izidih, ocenjenih pri več kot 200.000 ženskah, cepljenih med nosečnostjo.
English: Adults aged 18 years and older:
Slovenian: Odrasli, stari 18 let ali več:
English: In the unadjuvanted control group, as well as in the adjuvant control group, all animals died or had to be euthanized as they were moribund, three to four days after the start of challenge.
Slovenian: V kontrolnih skupinah so vse živali - tako tiste, ki niso dobile adjuvansa, kot tiste, ki so ga - poginile ali so jih morali evtanazirati, ker so bile tik pred poginom, od tri do štiri dni po začetku provokacije.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Pandemrix in one or more subsets of the paediatric population in the prevention of influenza infection (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij s cepivom Pandemrix pri eni ali več podskupinah pediatrične populacije za preprečitev okužbe z gripo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The vaccine contains 5 micrograms thiomersal
Slovenian: Cepivo vsebuje 5 mikrogramov tiomersala.
English: The MAH shall agree with Member States on the provision of a targeted communication to healthcare professionals which should address the following:
Slovenian: Imetnik dovoljenja za promet se bo z državami članicami dogovoril o zagotavljanju ciljanega obveščanja za zdravnike, ki mora obravnavati naslednje:
English: Additional information is available from the studies conducted with a vaccine similar in composition to Pandemrix but containing antigen derived from H5N1 viruses.
Slovenian: Dodatne informacije so na voljo iz študij, izvedenih s cepivom podobne sestave, kot je sestava cepiva Pandemrix, a z antigenom, pridobljenim iz virusov H5N1.
English: 50 vials: suspension (antigen)
Slovenian: 50 vial: suspenzija (antigen)
English: The use of a second dose should take into consideration the information provided in sections 4.4, 4.8 and
Slovenian: Pri uporabi drugega odmerka je treba upoštevati informacije v poglavjih 4.4, 4.8 in 5.1.
English: The anti-HA antibody responses 21 days after the first and the second dose were as follows:
Slovenian: Odzivi anti-HA protiteles so bili 21 dni po prvem in po drugem odmerku naslednji:
English: The side effects listed below have occurred with Pandemrix in clinical studies in adults, including the elderly.
Slovenian: Neželeni učinki, ki so navedeni spodaj, so se pojavili v kliničnih študijah s cepivom Pandemrix pri odraslih, vključno s starejšimi osebami.
English: • Flu-like symptoms
Slovenian: • gripi podobni simptomi.
English: [95% CI]
Slovenian: [95% IZ]
English: Epidemiological studies relating to Pandemrix in several European countries have indicated an increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated individuals.
Slovenian: Epidemiološke študije povezane s cepivom Pandemrix, so v več evropskih državah nakazale večje tveganje za narkolepsijo (s katapleksijo ali brez nje) pri cepljenih osebah v primerjavi z necepljenimi.
English: Pandemrix has been administered to women in each trimester of pregnancy.
Slovenian: Cepivo Pandemrix je bilo uporabljeno pri nosečnicah v vseh trimesečjih nosečnosti.
English: - Phenotypic characterization of hypocretin and influenza-specific T cells after stimulation with hypocretin or influenza peptides.
Slovenian: - Fenotipska opredelitev hipokretinskih in za influenco specifičnih celic T po stimulaciji s hipokretinskimi peptidi ali peptidi influence.
English: Allergic reactions:
Slovenian: Alergijske reakcije
English: The relationship between Pandemrix and narcolepsy is still under investigation.
Slovenian: Povezanost med cepivom Pandemrix in narkolepsijo ostaja predmet raziskovanja.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/
English: Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Pandemrix alone.
Slovenian: Sočasne uporabe ni spremljal večji delež lokalnih ali sistemskih reakcij kot uporaba cepiva Pandemrix samega.
English: What Pandemrix is and what it is used for What you need to know before you receive Pandemrix How Pandemrix is given
Slovenian: Kaj je cepivo Pandemrix in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili cepivo Pandemrix Kako uporabljati cepivo Pandemrix
English: For instructions on mixing of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila o mešanju zdravila pred uporabo glejte poglavje 6.6.
English: The neutralising antibody responses were as follows:
Slovenian: Odzivi nevtralizirajočih protiteles so bili:
English: Tell the doctor requesting these tests that you have recently been given Pandemrix.
Slovenian: Zdravnika, ki želi opraviti takšne preiskave opozorite, da ste bili pred kratkim cepljeni s cepivom Pandemrix.
English: It is recommended to equip the syringe with a needle gauge not larger than 23-G.
Slovenian: Injekcijsko brizgo je priporočljivo opremiti z iglo, ki ni večja od 23-G.
English: One pack of Pandemrix consists of:
Slovenian: Eno pakiranje cepiva Pandemrix vsebuje:
English: This may include the provision by the MAH of stickers with invented name and batch number with each pack of the vaccine.
Slovenian: To lahko vključuje dobavo nalepk z izmišljenim imenom in številko serije, ki jih bo imetnik dovoljenja za promet zagotovil z vsakim pakiranjem cepiva.
English: Pandemrix can be given at the same time as seasonal influenza vaccines that do not contain an adjuvant.
Slovenian: Cepivo Pandemrix je mogoče dati hkrati s sezonskimi cepivi proti gripi, ki ne vsebujejo adjuvansa.
English: Other medicines and Pandemrix
Slovenian: Druga zdravila in cepivo Pandemrix
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Slovenian: • Uradna sprostitev serije V skladu s 114. členom Direktive 2001/83/ES z vsemi dopolnitvami in spremembami, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
English: There are no safety, immunogenicity or efficacy data to support interchangeability of Pandemrix with other (H1N1)v vaccines.
Slovenian: Ni podatkov o varnosti, imunogenosti ali učinkovitosti, ki bi potrjevali zamenljivost cepiva Pandemrix z drugimi cepivi proti (H1N1)v.
English: Immunogenicity data obtained at three weeks after one dose of Pandemrix (H1N1)v suggest that a single dose may be sufficient.
Slovenian: Podatki o imunogenosti, dobljeni tri tedne po enem odmerku cepiva Pandemrix (H1N1)v kažejo, da morda lahko zadošča en sam odmerek.
English: Animal studies with Pandemrix do not indicate reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih, opravljene s cepivom Pandemrix, ne kažejo na vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines or have recently received any other vaccine.
Slovenian: Obvestite svojega zdravnika ali medicinsko sestro, če jemljete, če ste pred kratkim jemali, ali boste morda začeli jemati katerokoli drugo zdravilo.
English: The side effects listed above have also been observed with similar frequencies in clinical studies in children 10 to 17 years of age, except for redness at the injection site which was very common and sweating which was common.
Slovenian: Zgoraj navedene neželene učinke so s podobno pogostnostjo opažali v kliničnih študijah pri otrocih, starih od 10 do 17 let, z izjemo rdečine na mestu injiciranja, ki je bila zelo pogosta, in znojenja, ki je bilo pogosto.
English: It is recommended that subjects who receive a first dose of Pandemrix should complete the vaccination course with Pandemrix (see section 4.4).
Slovenian: Priporočljivo je, da osebe, ki dobijo prvi odmerek cepiva Pandemrix, cepljenje tudi zaključijo s cepivom Pandemrix (glejte poglavje 4.4).
English: Persons who have received a seasonal influenza vaccine that does not contain an adjuvant may receive Pandemrix after an interval of at least three weeks.
Slovenian: Osebe, ki so dobile cepivo proti sezonski gripi brez adjuvansa, lahko dobijo cepivo Pandemrix po presledku vsaj treh tednov.
English: Clinical studies have evaluated the incidence of adverse reactions in more than 1,000 subjects 18 years old and above who received Pandemrix (H1N1).
Slovenian: S kliničnimi študijami so ocenili incidenco spodaj navedenih neželenih učinkov pri več kot 1.000 preiskovancih, starih 18 let in več, ki so prejeli cepivo Pandemrix (H1N1).
English: Some side effects (including local redness and fever) occurred more frequently after the second dose compared to the first dose.
Slovenian: Nekateri neželeni učinki (vključno z lokalno rdečino in zvišano telesno temperaturo) so se pojavili pogosteje po drugem odmerku kot po prvem.
English: The per-dose frequency of the following adverse reactions was as shown in the table:
Slovenian: Pogostnost naslednjih neželenih učinkov na odmerek je bila takšna, kot je prikazano v preglednici:
English: The ability to induce protection against homologous and heterologous vaccine strains was assessed nonclinically using ferret challenge models.
Slovenian: Sposobnost za indukcijo zaščite proti homolognim in heterolognim cepilnim sevom so ocenili predklinično s provokacijskim modelom pri belem dihurju.
English: In particular rates of fever (axillary temperature ≥38°C) increased considerably after the second dose.
Slovenian: Še zlasti se je po drugem odmerku občutno povečal delež zvišane telesne temperature (aksilarna temperatura ≥ 38 °C).
English: All these side effects were reported very commonly after each dose.
Slovenian: Vsi ti neželeni učinki so bili zelo pogosti po vsakem odmerku.
English: They may also happen with Pandemrix.
Slovenian: Lahko se pojavijo tudi pri cepivu Pandemrix.
English: Pandemrix is a vaccine to prevent influenza (flu) caused by A(H1N1)v 2009 virus.
Slovenian: Cepivo Pandemrix je cepivo za preprečevanje gripe (influence), ki jo povzroča virus A(H1N1)v 2009.
English: The MAH shall complete, within the stated timeframe, the below measures:
Slovenian: Imetnik dovoljenja za promet bo naslednje ukrepe izpolnil v navedenih časovnih okvirih:
English: In study D-Pan-H1N1-008, the neutralising antibody responses were as follows:
Slovenian: V študiji D-Pan-H1N1-008 je bil odziv nevtralizirajočih protiteles naslednji: Nevtralizirajoča protitelesa v serumu
English: - Verify influenza-specificity of hypocretin-specific CD4 T cells from narcoleptic patients by complementary assays and verify if crossreactive CD4 T cells are found among influenza-specific CD4 T cells from healthy subjects after vaccination with Pandemrix or nonadjuvanted H1N1v vaccine.
Slovenian: - Preverjanje specifičnosti hipokretinsko specifičnih celic T CD4 narkoleptičnih bolnikov za influenco s komplementarnimi preizkusi ter preverjanje, ali se med za influenco specifičnimi celicami T CD4 zdravih oseb po cepljenju s cepivom Pandemrix ali cepivom H1N1v brez adjuvansa nahajajo navzkrižno reaktivne celice T CD4.
English: Two clinical studies evaluated the immunogenicity of Pandemrix in healthy subjects aged 18-60 years.
Slovenian: Z dvema kliničnima študijama so pri zdravih preiskovancih, starih od 18 do 60 let, ocenili imunogenost cepiva Pandemrix.
English: The neutralising antibody responses in subjects >60 years were as follows: Serum neutralising antibody
Slovenian: Odzivi nevtralizirajočih protiteles pri preiskovancih >60 let so bili naslednji: Nevtralizirajoča protitelesa v serumu
English: It is not known whether the observed effects would apply to administration of nonadjuvanted seasonal influenza vaccine after a single dose of Pandemrix or when longer dose intervals have elapsed since administration of Pandemrix.
Slovenian: Ni znano, ali bi ta učinek opazili tudi pri uporabi sezonskega cepiva proti gripi brez adjuvansa po enem odmerku cepiva Pandemrix ali če bi od uporabe cepiva Pandemrix minilo več časa.
English: If the mixed vaccine is stored in a refrigerator, it should be brought to room temperature (allow a minimum of 15 minutes) before each withdrawal.
Slovenian: Če pripravljeno cepivo shranjujete v hladilniku, ga je treba vsaj 15 minut pustiti na sobni temperaturi, preden izvlečete posamezni odmerek.
English: Suspension: multidose vial containing the antigen, Emulsion: multidose vial containing the adjuvant.
Slovenian: Suspenzija: večodmerna viala z antigenom, Emulzija: večodmerna viala z adjuvansom.
English: Twelve months after the first dose, the seroprotection rate was 100% in all age groups and dosage groups.
Slovenian: Dvanajst mesecev po prvem odmerku je bil delež serološke zaščite 100 % v vseh starostnih in odmernih skupinah.
English: Narcolepsywith or without cataplexy (see section 4.4)
Slovenian: narkolepsija s katapleksijo ali brez nje (glejte poglavje 4.4) zaspanost2
English: In the children who had received two adult (0.5 ml) doses, the seroprotection rates twelve months after the first dose were 100% for children aged 3-5 years and 98.0% for those aged 6-9 years.
Slovenian: Pri otrocih, ki so prejeli dva polna odmerka za odrasle (0,5 ml), je bil delež serološke zaščite dvanajst mesecev po prvem odmerku 100 % za otroke stare od 3 do 5 let ter 98,0 % za otroke stare od 6 do 9 let.
English: It is preferable that non-adjuvanted seasonal influenza vaccines should be administered before or with the first dose of Pandemrix.
Slovenian: Sezonsko cepivo proti gripi brez adjuvansa naj bo po možnosti uporabljeno pred ali s prvim odmerkom cepiva Pandemrix.
English: 4according to protocol
Slovenian: 4 Glede na protokol.
English: Twelve months after the first dose, the seroprotection rate was 85% in both age groups.
Slovenian: Dvanajst mesecev po prvem odmerku je bil delež serološke zaščite v obeh starostnih skupinah 85 %.