FrancophonIA/ELRC3.0 huggingface dataset:
English: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
Slovenian: želodčna razjeda in razjeda na retroperitonealna krvavitev krvavitev v prebavila in retroperitonealna krvavitev s smrtnim izidom, pankreatitis, kolitis (vključno z ulceroznim ali limfocitnim kolitisom), stomatitis
English: EU/1/09/561/010 Cartons of 28x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose
Slovenian: EU/1/09/561/010 škatla z 28x1 filmsko obloženo tableto v OPA/Al/PVC - Al perforiranih,
English: Mean peak plasma levels of unchanged clopidogrel (approximately 2.2-2.5 ng/ml after a single 75 mg oral dose) occurred approximately 45 minutes after dosing.
Slovenian: Po enkratnem in večkratnih peroralnih odmerkih po 75 mg na dan se klopidogrel hitro absorbira Povprečna največja koncentracija nespremenjenega klopidogrela v plazmi (približno 2,2-2,5 ng/ml po enem 75-mg peroralnem odmerku) se je pojavila približno 45 minut po odmerjanju.
English: How to take Clopidogrel Teva Pharma
Slovenian: Kako jemati zdravilo Klopidogrel Teva Phrama
English: What Clopidogrel Teva Pharma contains
Slovenian: Kaj vsebuje zdravilo Klopidogrel Teva Pharma
English: For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose.
Slovenian: - če je zamuda več kot 12 ur: bolnik naj naslednji odmerek vzame ob pravem času;
English: Clopidogrel Teva Pharma is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Slovenian: Zdravilo Klopidogrel Teva Pharma jemljejo odrasli za preprečevanje nastanka krvnih strdkov (trombov) v otrdelih krvnih žilah (arterijah).
English: A crossover study in 40 healthy subjects, 10 each in the four CYP2C19 metaboliser groups (ultrarapid, extensive, intermediate and poor), evaluated pharmacokinetic and antiplatelet responses using 300 mg followed by 75 mg/day and 600 mg followed by 150 mg/day, each for a total of 5 days (steady state).
Slovenian: Študija je ocenila farmakokinetiko in antiagregacijski odziv po uporabi odmerka 300 mg in potem 75 mg/dan ter 600 mg in potem 15 mg/dan, vsako od obeh shem skupaj 5 dni (stanje dinamičnega ravnovesja).
English: (including insulin), antiepileptic agents, and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions.
Slovenian: koronarne vazodilatatorje, antidiabetike (tudi insulin), antiepileptične učinkovine in antagoniste glikoproteinov IIb/IIIa.
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible side effects').
Slovenian: Pri manjših urezninah ali poškodbah, npr. pri britju, navadno ni razloga za skrb, če pa vas glede krvavitve skrbi, se nemudoma posvetujte z zdravnikom (glejte poglavje 4»Možni neželeni učinki«);
English: You should not breast-feed while taking this medicine.
Slovenian: Med jemanjem zdravila Klopidogrel Teva Pharma ne smete dojiti.
English: - If you have any of the side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Clopidogrel should be given as a single daily dose of 75 mg.
Slovenian: Klopidogrel dajemo kot enkratni dnevni odmerek po 75 mg, s hrano ali brez nje.
English: Batch
Slovenian: Heparin.
English: Powder: 220 mg Solvent:5 ml
Slovenian: prašek: 220 mg vehikel: 5 ml
English: 4 vials powder+ 4 vials solvent + 8 disposable 3 ml syringes + 8 disposable 27-gauge, ½ inch needles
Slovenian: 4 viale praška + 4 viale vehikla + 8 3-mililitrskih brizg za enkratno uporabo + 8 polpalčnih igel kalibra 27 za enkratno uporabo
English: Strength Pharmaceutical Form Route of Administration
Slovenian: Izmišljeno ime jakost farmacevtska oblika pot uporabe pakiranje vsebina velikost pakiranja
English: Subcutaneous use Powder: vial (glass) Solvent: LDPE vial
Slovenian: 80 mg/ml prašek in vehikel za raztopino za injiciranje subkutana uporaba prašek: viala (steklo) vehikel: viala iz LDPE
English: CZ-281 63 Kostelec nad Cernymi lesy Czech Republic
Slovenian: CZ-281 63 Kostelec nad Cernymi lesy
English: The following age groups will be used: < 2 years, 2-8 years, ≥ 9 years.
Slovenian: Uporabljene bodo naslednje starostne skupine: < 2 leti, 2-8 let, > 9 let.
English: The frequency cannot be estimated from the available data.
Slovenian: Pogostnosti ni mogoče oceniti iz razpoložljivih podatkov.
English: Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly to affect most countries and regions around the world.
Slovenian: Pandemska gripa je vrsta gripe, ki se pojavi vsakih nekaj desetletij in se zelo hitro širi, prizadene pa večino držav in regij po svetu.
English: • if you have a severe infection with a high temperature (over 38°C).
Slovenian: • če imate hudo okužbo in povišano temperaturo (nad 38°C).
English: For further information, see section 5.1.
Slovenian: Za dodatne informacije glejte poglavje 5.1.
English: - First data-lock point is 30 days later.
Slovenian: - Prvo zaključno obdobje zbiranja podatkov nastopi 30 dni pozneje.
English: The following principles should be followed when compiling the data:
Slovenian: Pri zbiranju podatkov je treba upoštevati naslednja načela:
English: All control animals succumbed to the infection.
Slovenian: Vse živali iz kontrolne skupine so podlegle okužbi.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Slovenian: Omogoča namreč stalno spremljanje razmerja med koristmi in tveganji z zdravilom.
English: • A protective response may not be induced in all vaccinees (see section 5.1).
Slovenian: • Zaščitni odziv morda ne bo dosežen pri vseh cepljenih osebah (glejte poglavje 5.1).
English: - A line listing of fatal cases will be provided in an Annex.
Slovenian: - V prilogi bo podan še vrstični seznam smrtnih primerov.
English: Read all of this leaflet carefully, before you are vaccinated because it contains important information for you.
Slovenian: Pred cepljenjem natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 October 2009
Slovenian: Datum prve odobritve: 16. oktober 2009
English: The vaccine works by helping the body to produce its own protection (antibodies) against the disease.
Slovenian: Cepivo deluje tako, da telo spodbudi k proizvajanju lastne zaščite (protiteles) proti bolezni.
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 (ES) št. 726/2004, mora imetnik dovoljenja za promet v spodaj navedenem časovnem okviru izvesti naslednje ukrepe:
English: A short summary should be provided in which validated signals and areas of concern are highlighted, taking into account information arising from the prospective cohort study described in 4.5.
Slovenian: Podan mora biti tudi kratek povzetek, v katerem bodo poudarjeni validirani signali in področja, ki so vzrok za zaskrbljenost, z upoštevanjem podatkov, dobljenih iz prospektivne kohortne študije, opisane v poglavju 4.5.
English: This vaccine complies with the WHO recommendation and EU decision for the pandemic.
Slovenian: Cepivo je skladno s priporočili SZO in Sklepom EU o pandemiji.
English: Moreover, a 6-monthly cycle may be too long to allow assessment of the safety of a vaccine for which high levels of exposure are expected within a short period of time.
Slovenian: Poleg tega je lahko 6-mesečni ciklus predolg, da bi omogočil ustrezno oceno varnosti cepiva, pri katerem lahko pričakujemo veliko stopnjo izpostavljenosti v kratkem obdobju.
English: The transient false positive reactions could be due to the IgM response by the vaccine.
Slovenian: Prehodne lažno pozitivne reakcije so lahko posledica odziva IgM na cepivo.
English: 60 years and above
Slovenian: 60 let in več
English: To put the safety report into context, a summary of vaccine distribution should be included and should provide details of the number of doses of vaccine distributed in i) EU member states for the reporting period by batch number, ii) EU member states cumulatively and iii) the rest of the world.
Slovenian: Da bi bilo poročilo o varnosti umeščeno v ustrezen kontekst, mora biti vključen tudi povzetek o distribuciji cepiva, v katerem morajo biti navedene podrobnosti o številu odmerkov cepiva v prometu v i) državah članicah EU za obdobje poročanja s številko serije, ii) državah članicah EU skupaj in iii) preostalem svetu.
English: Frequency 6 - 35 months 3 - 8 years
Slovenian: Pogostnost 6 - 35 mesecev 3 - 8 let
English: In the event of multiple signals, signal work-up may be prioritised and appropriate timelines for submission of a full signal evaluation report should be provided.
Slovenian: V primeru več signalov bo lahko obdelava signalov varnosti postala prioritetna in treba bo navesti ustrezne roke za predajo popolnega poročila o vrednotenju signalov.
English: During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan.
Slovenian: Med pandemijo bo predlagatelj izvedel prospektivno kohortno študijo, ki je določena v Načrtu farmakovigilance.
English: The Western Blot technique disproves the results.
Slovenian: S tehniko Western Blot so bili ti rezultati ovrženi.
English: Therefore, 6-monthly or annual PSURs falling within the pandemic period will be replaced by monthly “simplified PSURs” (S-PSUR) accompanied by a summary of vaccine distribution.
Slovenian: Zato bodo 6-mesečna ali letna poročila PSUR med obdobjem pandemije nadomeščena z mesečnimi ”poenostavljenimi poročili PSUR” (S-PSUR), ki jim bo priložen tudi povzetek o distribuciji cepiva.
English: Those which have not yet been entered should be reported in the following S-PSUR.
Slovenian: Tiste podatke, ki niso bili vneseni, pa je treba prijaviti v okviru naslednjega poročila S-PSUR.
English: - The clock should start from the first Monday after shipment of the first batch of vaccine.
Slovenian: - Čas začne teči prvi ponedeljek po odpremi prve serije cepiva.
English: Adults, older people and special risk groups
Slovenian: Odrasli, starejše osebe in skupine s posebnimi tveganji
English: When it has been agreed by the CHMP that the S-PSUR is no longer necessary, a full PSUR covering the period since the data lock point of the last routine PSUR will be submitted within a time frame to be agreed with the Rapporteur.
Slovenian: Ko bo odbor CHMP soglašal, da poročila S-PSUR niso več potrebna, bo predano celotno poročilo PSUR, ki bo zajemalo obdobje od zaključnega obdobja zbiranja podatkov zadnjega rutinskega poročila PSUR, in sicer v časovnem okviru, ki bo dogovorjen s poročevalcem.
English: Pandemic influenza vaccine should be used in accordance with official guidance.
Slovenian: Cepivo proti pandemski gripi je treba uporabljati v skladu z uradnimi smernicami.
English: • if you are having a blood test to look for evidence of infection with certain viruses.
Slovenian: • če ste naročeni za odvzem krvi, da se potrdi okužba z določenimi virusi.
English: narrow SMQ “Demyelination” (as GBS is also included in this SMQ, there will be an overlap in the number of cases for these two categories).
Slovenian: GBS tudi vključen v ta SMQ, bo prišlo do prekrivanja pri številu primerov za ti dve kategoriji).
English: Based on the assumption that product name will not be provided in a significant proportion of cases.
Slovenian: Na podlagi predpostavke, da pri velikem odstotku primerov ime cepiva ne bo navedeno.
English: Infants, children and adolescents: Adverse Reactions (Infants, Children and Adolescents)
Slovenian: Dojenčki, otroci in mladostniki: Neželeni učinki (dojenčki, otroci in mladostniki)
English: After first opening, the vial is to be used within a maximum of 3 hours.
Slovenian: Po prvem odprtju uporabite vialo v največ 3 urah.
English: Uncommon: generalised skin reactions
Slovenian: Občasni: generalizirane kožne reakcije
English: Infants, children, and adolescents
Slovenian: Dojenčki, otroci in mladostniki
English: During a pandemic situation, the resources must be concentrated on a timely and effective monitoring of the safety profile of the influenza vaccines used during the pandemic.
Slovenian: V času pandemije morajo biti viri osredotočeni na pravočasno in učinkovito spremljanje profila varnosti cepiv proti gripi, ki se uporabljajo v obdobju pandemije.
English: - All non-medically confirmed events are those that have been entered into the database by the data-lock point.
Slovenian: - Vsi nemedicinsko potrjeni dogodki oz. učinki so tisti, ki so bili vneseni v podatkovno bazo do zaključnega obdobja zbiranja podatkov.
English: - “Cumulatively” means since the use of the vaccine; events not reported during the period of interest should not be presented in the tables.
Slovenian: - ”Kumulativno” pomeni v času od uporabe cepiva; morebitni dogodki oz. učinki, ki niso prijavljeni v proučevanem obdobju, pa ne smejo biti podani v preglednicah.
English: You should tell your doctor before vaccination
Slovenian: Zdravniku pred cepljenjem povejte,
English: Day 180
Slovenian: 180. dan
English: In accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Slovenian: 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: The results indicate an overall decline in antibody levels over time.
Slovenian: Rezultati kažejo splošno upadanje protiteles v odvisnosti od časa.
English: Format of the simplified PSUR
Slovenian: Oblika poenostavljenih poročil PSUR
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Slovenian: Med znaki alergijske reakcije so lahko srbeč kožni izpuščaj, težko dihanje in otekanje obraza ali jezika.
English: • pain in arms and or legs (in the majority of cases reported as pain in the vaccination arm)
Slovenian: • bolečine v rokah ali nogah (v večini primerov je navedena bolečina v roki, v katero je bilo dano cepivo),
English: Patients with chronic disease conditions
Slovenian: Bolniki s kroničnimi bolezenskimi stanji
English: • Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed.
Slovenian: • Po cepljenju proti gripi je prišlo do lažno pozitivnih rezultatov seroloških testov, ki so bili izvedeni po metodi ELISA za odkrivanje protiteles proti HIV1, hepatitisu C in še posebej HTLV1.
English: The MAH shall perfom the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2. dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Adverse Reactions (Adults and Older People)
Slovenian: Neželeni učinki (odrasli in starejše osebe)
English: • If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection.
Slovenian: • Če pandemske razmere to dopuščajo, je treba cepljenje odložiti pri bolnikih, ki imajo hujše obolenje s povišano telesno temperaturo ali akutno okužbo.
English: This means that for scientific reasons, it has been impossible to get complete information on this medicine.
Slovenian: To pomeni, da iz znanstvenih razlogov ni bilo mogoče pridobiti vseh podatkov o cepivu.
English: Strain A/Indonesia/05/2005
Slovenian: Sev A/Indonesia/05/2005
English: Children and adolescents aged 3 to 17 years:
Slovenian: Otroci in mladostniki, stari od 3 do 17 let:
English: 21 Days after
Slovenian: 21 dni po
English: Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or foetal or neonatal toxicity.
Slovenian: Podatki pri nosečnicah, cepljenih z različnimi inaktiviranimi sezonskimi cepivi brez adjuvansa, ne kažejo na malformacijsko ali feto/neonatalno toksičnost.
English: 1 year
Slovenian: 1 leto
English: SPECIAL STORAGE CONDITIONS Store in refrigerator.
Slovenian: Shranjujte v hladilniku.
English: Very common (affects more than 1 user in 10): • pain at the injection site
Slovenian: Zelo pogosti (pojavijo se pri več kot 1 od 10 oseb): • bolečina na mestu injiciranja
English: • allergic reactions, including severe reactions leading to a dangerous decrease in blood pressure which, if untreated, may lead to shock.
Slovenian: • alergijske reakcije, vključno s hudimi reakcijami, ki povzročijo nevarno znižanje krvnega tlaka,
English: • As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Slovenian: • Kot pri vseh cepivih za injiciranje morata biti vedno takoj na voljo ustrezno medicinsko zdravljenje in zdravniški nadzor, če bi po cepljenju prišlo do sicer redke anafilaktične reakcije.
English: Day 42 a
Slovenian: 42. dan a
English: - All tables will be based on generic and not product-specific data1.
Slovenian: - V vseh preglednicah bodo podani generični podatki in ne podatki, ki so specifični za zdravilo1.
English: PT “Neuritis”
Slovenian: PT ”nevritis“
English: This should include data from ongoing studies, or actual use if applicable, of the ‘mock-up' strains.
Slovenian: Tu morajo biti vključeni tudi podatki iz študij, ki so v teku, oziroma morebitni podatki iz dejanske uporabe ‘modelnih' sevov cepiva.
English: Mock-up vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Slovenian: Modelna cepiva vsebujejo antigene gripe, ki se razlikujejo od antigenov v trenutno prisotnih virusih gripe.
English: Clinically significant alterations in liver enzymes and calcium levels have not been seen to date in human clinical studies.
Slovenian: Klinično pomembnih sprememb ravni jetrnih encimov in kalcija doslej še niso opazili v kliničnih študijah pri ljudeh.
English: Adults and children from 6 months onwards: One dose of 0.5 ml at an elected date.
Slovenian: Odrasli in otroci, starejši od 6 mesecev: En odmerek 0,5 ml naj bo injiciran na izbran datum.
English: Tested against
Slovenian: Testiran proti
English: Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Slovenian: Zato mora zdravnik oceniti koristi in morebitna tveganja cepljenja oseb s trombocitopenijo ali motnjami strjevanja krvi, ki bi povzročile kontraindikacije za intramuskularno injiciranje, razen če morebitni koristni učinki odtehtajo tveganje za krvavitve.
English: The most frequently occurring side effect was injection site pain, which was usually mild.
Slovenian: Najpogostejši neželeni učinek je bila bolečina na mestu injiciranja, ki je bila po navadi blaga.
English: Such reactions occurred both in patients with a history of multiple allergies and in patients with no known allergy.
Slovenian: Te reakcije so se pojavile pri bolnikih z več alergijami v anamnezi in bolnikih brez znane alergije.
English: Month 12-15 Month 24
Slovenian: 6. mesec 12-15. mesec 24. mesec
English: PT “Vaccination failure”.
Slovenian: PT ”neuspešnost cepljenja”
English: A second dose of 0.5 ml should be given after an interval of at least three weeks.
Slovenian: Drugi odmerek 0,5 ml je treba dati po presledku vsaj treh tednov.
English: However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.
Slovenian: V pandemskih razmerah je cepljenje morda vseeno upravičeno, vendar ob zagotovitvi opreme za oživljanje, ki mora biti takoj na voljo.
English: Such reactions have happened both in people who have allergies and in those who do not;
Slovenian: Takšne reakcije so se pojavile pri osebah z alergijami in pri osebah brez alergij;
English: There were fewer side effects after the second vaccination compared with the first.
Slovenian: Po drugem cepljenju je bilo manj neželenih učinkov kot po prvem.
English: Prophylaxis of influenza in an officially declared pandemic situation.
Slovenian: Profilaksa gripe pri uradno razglašeni pandemiji.
English: From post-marketing surveillance with a whole virion, Vero cell derived, H1N1 vaccine, the following adverse reactions have been reported (the frequency of these adverse reactions is not known as it cannot be estimated from the available data):
Slovenian: Med spremljanjem cepiva proti H1N1 s celimi virioni, razmnoženimi v celicah Vero, po pridobitvi dovoljenja za promet so poročali o naslednjih neželenih učinkih (pogostnost teh neželenih učinkov ni znana, saj je iz razpoložljivih podatkov ni možno oceniti):
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/
Slovenian: Podrobne informacije o cepivu so objavljene na spletni strani Evropske agencije za zdravila (EMA): http://www.ema.europa.eu.
English: - Vaccination failure:
Slovenian: - neuspešnost cepljenja:
English: • feeling cold
Slovenian: • občutek mraza.
English: - Except for Table 1, all tables will be based on number of reactions (presented on PT level, sorted by System Organ Class [SOC] and High Level Term [HLT]) and not number of cases.
Slovenian: - Razen preglednice 1 bo v vseh preglednicah navedeno število učinkov (predstavljenih po stopnji PT in razvrščenih po organskih sistemih [SOC] in terminu visoke stopnje [HLT]) in ne število primerov.
English: 3 - 8 years
Slovenian: 3-8 let
English: Very rare: vasculitis with transient renal involvement.
Slovenian: Zelo redki: vaskulitis s prehodno prizadetostjo ledvic.
English: In the clinical studies conducted in infants, children and adolescents, the incidence and nature of symptoms after the first and second vaccination were similar to those occurred in adults and older people.
Slovenian: V kliničnih študijah pri dojenčkih, otrocih in mladostnikih sta bili pojavnost in narava simptomov po prvem in drugem cepljenju podobni kot pri odraslih in starostnikih.
English: During the pandemic, the applicant will collect clinical safety and effectiveness data of the pandemic vaccine and submit this information to the CHMP for evaluation.
Slovenian: Med pandemijo bo predlagatelj zbiral klinične podatke o varnosti in učinkovitosti cepiva s pandemskim sevom in jih predložil CHMP v ovrednotenje.
English: The report should include the following Tables of aggregate data (using the pre-defined templates attached in Annex 2).
Slovenian: To poročilo naj vključuje naslednje preglednice sestavljenih podatkov (z uporabo vnaprej opredeljenih predlog,
English: However, in a pandemic situation, your doctor may recommend to give the vaccine.
Slovenian: V pandemskih razmerah vam bo zdravnik morda vseeno svetoval cepljenje s cepivom.
English: Outside of the pandemic period, the normal PSUR periodicity and format will be maintained, with a specific review of AESI.
Slovenian: V času zunaj obdobja pandemije bosta ohranjena običajna periodičnost in oblika predajanja poročil PSUR, s posebnim pregledom neželenih učinkov posebnega pomena (AESI).
English: • reduced blood pressure, feeling faint (syncope)
Slovenian: • znižan krvni tlak, izguba zavesti (sinkopa),