FrancophonIA/ELRC3.0 huggingface dataset:
English: Interactions with other medicinal products (section 4.5 of the SmPC) have been summarised in additive interactions with other local anaesthetics, sedatives, halogenated volatile anaesthetics, postganglionic adrenergic blocking agents, non-selective beta-adrenergic blockers, tricyclic antidepressants, catechol-O-methyl transferase inhibitors, drugs causing arrhythmias, ergot-type oxytocic drugs, sympathomimetic vasopressors and phenothiazines.
Slovenian: Medsebojno delovanje z drugimi zdravili (poglavje 4.5 povzetka glavnih značilnosti zdravila) je bilo povzeto tako, da vključuje aditivno medsebojno delovanje z drugimi lokalnimi anestetiki, sedativi, halogeniranimi hlapnimi anestetiki, postganglijskimi adrenergičnimi zaviralci, neselektivnimi betaadrenergičnimi zaviralci, tricikličnimi antidepresivi, zaviralci katehol-O-metiltransferaze, zdravili, ki povzročajo aritmije, oksitocinskimi zdravili ergotne vrste, simpatomimetičnimi vazopresorji in fenotiazini.
English: • The Committee reviewed the totality of the data submitted by the Marketing Authorisation Holder in support of the proposed harmonisation of the product information;
Slovenian: • odbor je pregledal vse podatke, ki jih je v podporo predlagani uskladitvi informacij o zdravilu predložil imetnik dovoljenja za promet z zdravilom;
English: • In addition, the Committee reviewed the totality of the documentation submitted by the Marketing Authorisation Holder in support of the proposed harmonised Quality documentation (Module 3);
Slovenian: • odbor je prav tako pregledal vso dokumentacijo, ki jo je v podporo predlagani usklajeni dokumentaciji o kakovosti (modul 3) predložil imetnik dovoljenja za promet z zdravilom;
English: The finished product is presented as a solution for injection containing articaine hydrochloride 40 mg/ml and adrenaline tartrate in 2 strengths: articaine/adrenaline 40/0.005 mg/ml and articaine/adrenaline 40/0.01 mg/ml.
Slovenian: Končno zdravilo ima obliko raztopine za injiciranje, ki vsebuje artikainijev hidroklorid 40 mg/ml in adrenalinijev tartrat v dveh jakostih: artikain/adrenalin 40/0,005 mg/ml in artikain/adrenalin 40/0,01 mg/ml.
English: Information about the time to onset and description of slow or delayed onset for dosing overdose has been included at the request of the CHMP.
Slovenian: Na zahtevo odbora CHMP so vključili informacije o času do pojava učinkov prevelikega odmerjanja in opisu počasnega ali zapoznelega pojava učinkov prevelikega odmerjanja.
English: Section 4.2 - Posology and method of administration Posology
Slovenian: Poglavje 4.2 - Odmerjanje in način uporabe Odmerjanje
English: The CHMP did not endorse the omission of the wording regarding avoidance of administration into inflamed or infected tissues as injection of local anaesthetics into such tissues may result in decreased effectiveness of the anaesthetics.
Slovenian: Odbor CHMP ni odobril opustitve besedila o izogibanju dajanju v vneto ali okuženo tkivo, saj lahko
English: The data supporting contraindications included in section 4.3 of the SmPC was discussed by the MAHs and the rationale provided for keeping them in the SmPC was agreed by the CHMP for patients with a
Slovenian: Imetniki dovoljenja za promet z zdravilom so razpravljali o podatkih, ki podpirajo kontraindikacije, vključene v poglavje 4.3 povzetka glavnih značilnosti zdravila, odbor CHMP pa je soglašal z utemeljitvijo za njihovo ohranitev v povzetku glavnih značilnosti zdravila za bolnike z anamnezo preobčutljivosti za artikain, adrenalin ali katero koli pomožno snov končnega zdravila in bolnike z epilepsijo, ki je z zdravljenjem ni mogoče ustrezno nadzorovati.
English: A harmonised version of section 4.8 of the SmPC regarding adverse events has been agreed by the CHMP after assessing data from the MAH's global pharmacovigilance database and literature data.
Slovenian: Odbor CHMP se je po oceni podatkov iz svetovne farmakovigilančne zbirke podatkov imetnika dovoljenja za promet z zdravilom in podatkov iz literature dogovoril o usklajeni različici poglavja 4.8 povzetka glavnih značilnosti zdravila o neželenih učinkih.
English: - Report submission is no later than day 22 (i.e. the following Monday).
Slovenian: - Predložitev poročila je najkasneje na 22. dan (npr. naslednji ponedeljek).
English: As an identified risk, an appropriate warning should be included in section 4.4.
Slovenian: Glede na ugotovljeno tveganje je treba ustrezno opozorilo vključiti v poglavje 4.4.
English: • At the request of the European Medicines Agency
Slovenian: • Na zahtevo Evropske agencije za zdravila.
English: Adults from the age of 18 years onwards:
Slovenian: Odrasli, starejši od 18 let:
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Slovenian: CHMP soglaša z znanstvenimi zaključki PRAC.
English: - First data-lock point is 14 days later.
Slovenian: - Prvo zaključeno obdobje zbiranja podatkov je 14 dni kasneje.
English: All events occurring in pregnant women
Slovenian: Vsi dogodki, ki se pojavijo pri nosečnicah.
English: Presentation of data will take into consideration the following recommendations:
Slovenian: Pri predstavitvi podatkov je potrebno upoštevati naslednja priporočila:
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: - In Tables 1 to 5, numbers will be provided for events received during the reporting period and
Slovenian: - V preglednicah 1 do 5, bodo na voljo števila za dogodke, prejete med obdobjem poročanja in
English: Protocol of the registry will be submitted as part of RMP, during the pandemic
Slovenian: Protokol registra bo predložen kot del RMP med pandemijo.
English: In the first few weeks after vaccination with Pumarix the results of these tests may not be correct.
Slovenian: V prvih nekaj tednih po cepljenju s cepivom Pumarix so lahko rezultati teh preiskav napačni.
English: This means that for scientific reasons it has not been possible to obtain complete information on this medicinal product.
Slovenian: To pomeni, da zaradi znanstvenih razlogov ni bilo mogoče pridobiti celotnih informacij o tem cepivu.
English: - The clock will start from the first Monday after shipment of the first batch of vaccine.
Slovenian: - Čas bo pričel teči prvi ponedeljek po pošiljki prve serije cepiva.
English: SPECIAL STORAGE CONDITIONS Storage in a refrigerator.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku.
English: All events occurring in the following age groups: 6-23 months, 2-8 years, 8-17 years, 18-60 years, >60 years
Slovenian: Vsi dogodki, ki se pojavijo pri naslednjih starostnih skupinah: 6-23 mesecev, 2-8 let, 8-17 let, 18-60 let, > 60 let.
English: It is best to see how Pumarix affects you before you try these activities.
Slovenian: Najbolje je, da ugotovite, kako cepivo Pumarix vpliva na vas, preden opravljate te dejavnosti.
English: - All tables will be based on generic and not product-specific data.
Slovenian: - Vse preglednice bodo temeljile na generičnih podatkih in ne na podatkih specifičnih za zdravilo.
English: This can cause bleeding or bruising.
Slovenian: To lahko povzroči krvavitve ali modrice.
English: In relation to the identified risk of fever in children (<6 years), the PRAC does not agree with the MAH that the EU SmPC contains appropriate information on this safety concern.
Slovenian: V zvezi z ugotovljenim tveganjem za zvišano telesno temperaturo pri otrocih (< 6 let) PRAC ne soglaša z imetnikom dovoljenja za promet, ki navaja, da EU SmPC vsebuje ustrezne informacije v zvezi s temi pomisleki glede varnosti.
English: • Serious stabbing or throbbing pain along one or more of your nerves
Slovenian: • Resna zbadajoča ali kljuvajoča bolečina vzdolž enega ali več živcev.
English: Pandemic influenza vaccine should be used in accordance with official guidance.
Slovenian: Cepivo proti pandemski gripi je treba uporabljati v skladu z uradnimi priporočili.
English: All signal evaluation reports should be provided, including those that were subsequently not
Slovenian: Predložiti je potrebno vsa poročila vrednotenja signalov, vključno s tistimi, ki posledično niso bili identificirani kot signali.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/664/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/664/001
English: A summary of vaccine distribution shall be included and provide details of the number of EU member states for the reporting period by batch number,
Slovenian: Vključiti je potrebno povzetek distribucije cepiva in zagotoviti podrobnosti o številu i) državah članicah EU za obdobje poročanja po številki serije,
English: The use of Pumarix may be considered during pregnancy if this is thought to be necessary, taking into account official recommendations.
Slovenian: Cepivo Pumarix se lahko uporabi med nosečnostjo, če se oceni, da je potrebno in ob upoštevanju uradnih priporočil.
English: - Tables 1 to 4 will be based on events reported from healthcare professionals only.
Slovenian: - Preglednice 1 do 4 bodo temeljile le na poročilih zdravstvenega osebja.
English: A short summary shall also be provided with the periodic safety update reports, in which any area of concern should be highlighted, signal work-up prioritised (if the event of multiple signals) and appropriate timelines for submission of a full signal evaluation report provided.
Slovenian: Z rednim posodobljenim poročilom o varnosti je potrebno predložiti tudi kratek povzetek, v katerem je potrebno označiti vsa področja, ki so vzrok za zaskrbljenost, prednostno razvrstiti obdelavo signalov (v primeru pojava večih signalov) in pripraviti primerne časovnice za predložitev celotnega poročila vrednotenja signalov.
English: - Serious expected reactions will be reviewed by the MAH as part of their signal detection procedures and will only form part of the report if an issue of concern arises.
Slovenian: - Resne pričakovane neželene učinke bo pregledal imetnik dovoljenja za promet kot del postopkov ugotavljanja signala in bodo tvorili del poročila le v primeru nastanka zadevnih vprašanj.
English: Taking into account the PRAC Assessment Report on the PSUR for Pumarix, the scientific conclusions of the PRAC are as follows:
Slovenian: Upoštevaje poročilo PRAC o oceni PSUR za cepivo Pumarix so znanstveni zaključki PRAC naslednji:
English: Data obtained with the mock-up vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with mock-up vaccines are relevant for the pandemic vaccines.
Slovenian: Podatki, dobljeni z modelnim cepivom, bodo podpirali strategijo cepljenja, ki bo verjetno uporabljena za pandemsko cepivo: podatki o klinični imunogenosti, varnosti in reaktogenosti, pridobljeni z modelnimi cepivi, so pomembni za pandemska cepiva.
English: The second dose should be given after an interval of at least three weeks after the first dose.
Slovenian: Drugi odmerek je potrebno dati po presledku vsaj treh tednov po prvem odmerku.
English: - Periodicity will be reviewed by the MAH and the (Co)Rapporteur at 3 monthly intervals.
Slovenian: - Periodičnost bo v 3-mesečnih razmikih pregledal imetnik dovoljenja za promet in (so)poročevalec.
English: Pumarix is not intended to be given at the same time as some other vaccines.
Slovenian: Cepivo Pumarix ni namenjeno za dajanje ob istem času z nekaterimi drugimi cepivi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 04 March 2011
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 04/03/2011
English: During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Slovenian: Med obdobjem pandemije pogostnost predložitve rednih posodobljenih poročil o varnosti, kot je opredeljena v 24. členu uredbe (ES) št. 726/2004 ne bo zadoščala za spremljanje varnosti pandemskega cepiva, pri katerem je pričakovati visoko raven izpostavljenosti v kratkem časovnem obdobju.
English: - No line listings are required - these can be provided in signal evaluation reports as necessary.
Slovenian: - Vrstični seznami niso zahtevani - če je potrebno, se jih lahko predloži v poročilih vrednotenja
English: • Unusual weakness
Slovenian: • neobičajna oslabelost,
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Slovenian: • V 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja).
English: This section describes the clinical experience with the mock-up vaccines following a two-dose
Slovenian: To poglavje opisuje klinične izkušnje z modelnimi cepivi po uporabi dveh odmerkov.
English: The vaccine contains an ‘adjuvant' AS03.
Slovenian: Cepivo vsebuje »adjuvans« (AS03).
English: During the pandemic, the applicant will conduct a prospective cohort study as identified in the
Slovenian: Med pandemijo bo vlagatelj izvajal prospektivno kohortno študijo, kot je navedeno v načrtu
English: Mock-up vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Slovenian: Modelna cepiva vključujejo antigene gripe, ki se razlikujejo od tistih v trenutno krožečih virusih gripe.
English: A cumulative overview of all events reported during the period, stratified according to type of reporter (patient or health care professional), seriousness, expectedness, and whether spontaneous or solicited.
Slovenian: Kumulativen pregled vseh dogodkov, poročanih med obdobjem, razvrščenih glede na tip poročevalca (pacient ali zdravstveno osebje), resnost, pričakovanost in spontanost ali ne spontanost.
English: 4.5 Interaction with other medicinal products and other forms of interaction There are no data on co-administration of Pumarix with other vaccines.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Podatkov o sočasni uporabi cepiva Pumarix z drugimi cepivi ni.
English: Some effects listed in Section 4 “Possible side effects” may affect your ability to drive or use tools or machines.
Slovenian: Nekateri učinki, našteti v poglavju 4, "Možni neželeni učinki", lahko neugodno vplivajo na vašo sposobnost vožnje in upravljanja z orodji in s stroji.
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: • Uradno sproščanje serije V skladu s 114. členom Direktive 2001/83/EC, opravi sproščanje serije državni laboratorij ali laboratorij, imenovan v ta namen.
English: This medicine has been authorised under 'exceptional circumstances'.
Slovenian: To cepivo je pridobilo dovoljenje za promet v »Izjemnih okoliščinah«.
English: Depending on and after implementation of vaccine strain, when first pandemic will take place.
Slovenian: V odvisnosti od in po uvedbi cepilnega seva, ob prvem pojavu pandemije.
English: There are currently no data available on the use of Pumarix in pregnancy.
Slovenian: Trenutno ni podatkov o uporabi cepiva Pumarix med nosečnostjo.
English: The MAH shall perform the studies and pharmacovigilance activities detailed in the Pharmacovigilance Plan and requested as specific obligations.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel študije in farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance in zahtevane kot posebne zahteve.
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 če dojite, če menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden dobite cepivo.
English: Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit balance in a pandemic.
Slovenian: Takšne okoliščine zahtevajo hitro prijavljanje varnostnih informacij, ki so lahko pri pandemiji izjemno pomembne za razmerje med tveganjem in koristjo.
English: Prompt analysis of cumulative safety information, in light of extent of exposure, will be crucial for regulatory decisions and protection of the population to be vaccinated.
Slovenian: V luči obsega izpostavljenosti bo takojšnja analiza kumulativnih informacij o varnosti ključnega pomena za regulativno odločanje in zaščito prebivalstva, ki bo cepljeno.
English: All events reported by patients that have been entered into the database by data-lock point
Slovenian: Vsi dogodki, ki so jih poročalibolniki, ki so bili v podatkovno bazo vneseni po zaključenem obdobju zbiranja podatkov.
English: As with all vaccines, Pumarix may not fully protect all persons who are vaccinated.
Slovenian: Kot druga cepiva tudi cepivo Pumarix morda ne bo popolnoma zaščitilo vseh cepljenih oseb.
English: In addition, duration a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
Slovenian: Poleg tega med trajanjem pandemije, viri, potrebni za poglobljeno vrednotenje rednih posodobljenih poročil o varnosti zdravila v obliki, kot je definirana v volumnu 9A Pravil, ki urejajo zdravila v Evropski skupnosti (Volume 9a - “Rules Governing Medicinal Product in the European Union”), morda ne bodo zadostovali za hitro identifikacijo novih varnostnih izsledkov.
English: • if you have problems with your immune system, since your response to the vaccine may then be
Slovenian: • če imate težave z imunskim sistemom, saj bo vaš odziv na cepivo lahko slabši.
English: Fatal and/or life-threatening reactions - for each Preferred Term (PT), including the proportion of fatal reports
Slovenian: Smrtne in/ali življenje ogrožujoče reakcije - za vsak prednostni termin (PreferredTerm),
English: Day 42
Slovenian: 42. dan
English: Adults from the age of 18 years onwards: one dose of 0.5 ml at an elected date.
Slovenian: Odrasli, starejši od 18 let: En 0,5-ml odmerek na izbrani datum.
English: A second dose of 0.5 ml should be given after an interval of at least three weeks.
Slovenian: Drugi 0,5-ml odmerek je potrebno dati po presledku vsaj treh tednov.
English: What Pumarix is and what it is used for What you need to know before you are given Pumarix
Slovenian: Kaj je cepivo Pumarix in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili cepivo Pumarix
English: Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades.
Slovenian: Pandemska gripa je vrsta gripe, ki se pojavi v presledkih, ki trajajo od manj kot deset let do več desetletij, in se hitro širi po vsem svetu.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
Slovenian: Zaradi pomanjkanja študij kompatibilnosti cepiva ne smemo mešati z drugimi zdravili.
English: Pumarix can still be given but your response to the vaccine may be poor.
Slovenian: Cepivo Pumarix lahko dobite kljub temu, a vaš odziv nanj je lahko šibek.
English: Moreover section 4.8 should be revised to reflect reactogenicity data from the three paediatric studies D-Pan H5N1-009, -013 and
Slovenian: Poleg tega je treba poglavje 4.8 revidirati tako, da bo odražalo podatke o reaktogenosti, zbrane v treh pediatričnih študijah D-Pan H5N1-009, -013 in 032.
English: The safety and efficacy of Pumarix in children aged less than 3 years and in children and adolescents aged 10 to 17 years have not been established.
Slovenian: Varnosti in učinkovitosti cepiva Pumarix pri otrocih, mlajših od 3 let, in otrocih in mladostnikih, starih od 10 do 17 let, niso ugotavljali.
English: The CHMP recommends that the terms of the Marketing Authorisation should be varied.
Slovenian: CHMP priporoča spremembo pogojev dovoljenja za promet z zdravilom.
English: Therefore, in view of the available data regarding fever in children, the PRAC considered that changes to the product information were warranted.
Slovenian: PRAC zato glede na dostopne podatke o zvišani telesni temperaturi pri otrocih meni, da so spremembe v informacijah o zdravilu utemeljene.
English: These antigens can be considered as “novel” antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Slovenian: Te antigene je mogoče obravnavati kot "nove" antigene in simulirajo okoliščine, v katerih ciljna populacija za cepljenje še ni bila v stiku z antigenom.
English: Pumarix contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose.
Slovenian: Cepivo Pumarix vsebuje manj kot 1 mmol natrija (23 mg) in manj kot 1 mmol kalija (39 mg) na odmerek.
English: For storage conditions after mixing of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja zdravila po mešanju glejte poglavje 6.3.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Pumarix in one or more subsets of the paediatric population in influenza infection caused by an influenza strain contained in the vaccine or related to a strain contained in the vaccine.
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij s cepivom Pumarix pri eni ali več skupinah pediatrične populacije za okužbo z gripo, povzročeno s sevom v cepivu, ali s sevom, sorodnim sevu v cepivu.
English: At day 42 and six months after the second dose, the anti-HA antibody responses were as follows:
Slovenian: Na dan 42 in šest mesecev po drugem odmerku so bili odzivi protiteles anti-HA naslednji:
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Slovenian: Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (EC) št.726/2004,
English: Pumarix can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Pumarix takes due account of the officially declared pandemic strain.
Slovenian: Cepivo Pumarix se lahko sprosti v promet le, če SZO/EU uradno razglasi pandemijo gripe in pod pogojem, da imetnik dovoljenja za promet s cepivom Pumarix upošteva uradno razglašen pandemski sev.
English: - All tables will be based on number of events (presented on PT level, sorted by System Organ Class
Slovenian: - Vse preglednice bodo temeljile na številu dogodkov (predstavljenih na nivoju PT, razvrščenih po organskih sistemih (System Organ Class - SOC) in ne po številu primerov.
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 ali ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
English: This leaflet was last revised in {MM/YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano dne:
English: Your doctors know that this might happen and will have emergency treatment
Slovenian: Vaš zdravnik ve, da se to lahko zgodi in bo imel nujna zdravila pripravljena za uporabo.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je predložen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
English: If you have any further questions on the use of this vaccine, ask your doctor or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z vašim zdravnikom ali medicinsko sestro.