FrancophonIA/ELRC3.0 huggingface dataset:
English: At the end of the three weeks the mean reduction from baseline in the primary efficacy variable, trough seated systolic blood pressure (SeSBP) was 11.7 mm Hg (low dose), 9.3 mm Hg (medium dose), 13.2 mm Hg (high dose).
Slovenian: Po koncu 3-tedenskega obdobja se je primarna spremenljivka učinkovitosti, najnižji sistolični krvni tlak sede (SeSBP - seated systolic blood pressure), v primerjavi z izhodiščem znižala za povprečno 11,7 mmHg (nizki odmerek), 9,3 mmHg (srednji odmerek) oz. 13,2 mmHg (visoki odmerek).
English: 590 patients with type 2 diabetes, microalbuminuria (30-300 mg/day) and normal renal function (serum creatinine ≤ 1.5 mg/dl in males and < 1.1 mg/dl in females).
Slovenian: IRMA 2 je dvojno slepa, s placebom kontrolirana raziskava smrtnosti pri 590 bolnikih z diabetesom tipa 2, mikroalbuminurijo (30-300 mg/dan) in normalno ledvično funkcijo (serumski kreatinin pri moških ≤ 1,5 mg/dl, pri ženskah < 1,1 mg/dl).
English: Potassium supplements and potassium-sparing diuretics Based on experience with the use of other medicinal products that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Slovenian: Na podlagi izkušenj z drugimi zdravili, ki vplivajo na sistem renin-angiotenzin, lahko sočasna uporaba diuretikov, ki varčujejo s kalijem, dodatkov kalija, nadomestkov soli, ki vsebujejo kalij, ali drugih zdravil, ki lahko povečajo koncentracijo kalija v serumu (npr. heparin), zviša kalij v serumu in zato ni priporočljiva (glejte poglavje 4.4).
English: If you get excessive vomiting or diarrhoea
Slovenian: • če začnete prekomerno bruhati ali dobite hudo drisko
English: Pack size of 28 film-coated tablets in non-perforated calendar blisters.
Slovenian: Velikost pakiranja po 28 filmsko obloženih tablet v koledarskem pretisnem omotu.
English: • Tablet coating: polydextrose, titanium dioxide, hypromellose and macrogol 4000.
Slovenian: • filmska obloga: polidekstroza Fcc, titanov dioksid, hipromeloza 2910 15 cP in makrogol
English: if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Slovenian: • če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren.
English: In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Slovenian: V kliničnih študijah hidroklorotiazid ne vpliva na farmakokinetiko irbesartana.
English: Pregelatinized starch (maize) Poloxamer 188
Slovenian: poloksamer 188
English: Not known (frequency cannot be estimated from the available data): feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis) and severe allergic reactions (anaphylactic shock).
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): vrtoglavica, glavobol, motnje okušanja, zvonenje v ušesih, mišični krči, bolečine v sklepih in mišicah, zmanjšano število trombocitov, nenormalno delovanje jeter, zvišane vrednosti kalija v krvi, okvara delovanja ledvic,
English: Teva Pharma Belgium N.V./S.A/AG Tél/Tel: +32 38207373
Slovenian: België/Belgique/Belgien Teva Pharma Belgium N.V./S.A/AG Tél/Tel: +32 38207373
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Irbesartan Teva Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
Slovenian: Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
English: Irbesartan Teva is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Slovenian: Zdravila Irbesartan Teva ne smete jemati, če ste noseči dlje kot tri mesece, saj lahko zdravilo v tem obdobju resno škoduje vašemu otroku (glejte poglavje o nosečnosti).
English: No dosage adjustment is necessary in elderly people.
Slovenian: Prilagajanje odmerka za starejše bolnike ni potrebno.
English: Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Slovenian: • Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): hitro utripanje srca, rdečica, kašelj, driska, motnje prebave/zgaga, spolna disfunkcija (motnje pri spolnih aktivnostih), bolečina v prsnem košu.
English: Investigations Very common:
Slovenian: Zelo pogosti:
English: The other side of the tablet debossed with number “7466”.
Slovenian: Na drugi strani tablete je vtisnjena številka “7466”.
English: Sixty per cent (60 %) of patients in the placebo group reached this target blood pressure whereas this figure was 76 % and 78 % in the irbesartan and amlodipine groups respectively.
Slovenian: V placebo skupini je doseglo ciljni krvni tlak 60 % bolnikov, v skupini z irbesartanom 76 % in v skupini z amlodipinom 78 %.
English: significant increases in plasma creatine kinase were commonly observed (1.7 %) in irbesartan treated subjects.
Slovenian: Pri bolnikih zdravljenih z irbesartanom so pogosto (1,7 %) opazili pomembno povečanje plazemske kreatinin kinaze.
English: Pharmacotherapeutic group: Angiotensin-II antagonists, plain.
Slovenian: Farmakoterapevtska skupina: Antagonisti angiotenzina II, enokomponentna zdravila.
English: • Obligation to conduct post-authorisation measures
Slovenian: • Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe: Pogoji dovoljenja za promet z zdravilom
English: Talk to your doctor before taking Irbesartan Teva and if any of the following apply to you:
Slovenian: Pred začetkom jemanja zdravila Irbesartan Teva se posvetujte z zdravnikom, če za vas velja karkoli od spodaj navedenega:
English: What Irbesartan Teva looks like and contents of the pack
Slovenian: Izgled zdravila Irbesartan Teva in vsebina pakiranja
English: The other side of the tablet debossed with number “7465”.
Slovenian: Na drugi strani tablete je vtisnjena številka “7465”.
English: Metabolism and nutrition disorders Not known:
Slovenian: Presnovne in prehranske motnje Neznana:
English: Your doctor will normally advise you to stop taking Irbesartan Teva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan Teva.
Slovenian: Zdravnik vam bo praviloma svetoval, da zdravljenje z zdravilom Irbesartan Teva prekinete še preden zanosite ali takoj,
English: The efficacy of irbesartan is not influenced by age or gender.
Slovenian: Spol in starost ne vplivata na učinkovitost irbesartana.
English: The other side of the tablet debossed with number “7464”.
Slovenian: Na drugi strani tablete je vtisnjena številka “7464”.
English: Teva Denmark A/S Tlf: +45 44985511
Slovenian: Tlf: +45 44985511
English: In the female and black subgroups which represented 32 % and 26 % of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it. As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebobased regimen.
Slovenian: V sekundarnem izidu fatalnih in nefatalnih srčnožilnih dogodkov med tremi skupinami celotne populacije ni bilo razlik, čeprav je bilo opaziti povečano pogostost nefatalnih MI (miokardni infarkt) pri ženskah in zmanjšano pogostost nefatalnih MI pri moških v skupini z irbesartanom, v primerjavi s placebo skupino.
English: The dose may later be increased to 300 mg once daily depending on blood pressure response.
Slovenian: • Bolniki z visokim krvnim tlakom Običajni odmerek je 150 mg enkrat na dan. Odmerek se lahko kasneje poveča na 300 mg enkrat na dan, odvisno od odziva krvnega tlaka.
English: Exposure to AIIRAs therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Slovenian: Znano je, da izpostavljenost antagonistom angiotenzina II v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano delovanje ledvic, oligohidramnij, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (odpoved ledvic, hipotenzija, hiperkaliemija) (glejte poglavje 5.3).
English: Approximately 33 % of patients in the irbesartan group reached the primary renal composite endpoint compared to 39 % and 41 % in the placebo and amlodipine groups [20 % relative risk reduction versus placebo (p = 0.024) and 23 % relative risk reduction compared to amlodipine (p = 0.006)].
Slovenian: [20 % relativno zmanjšanje tveganja v primerjavi s placebom (p = 0,024) in 23 % relativno zmanjšanje tveganja v primerjavi z amlodipinom (p = 0,006)].
English: If you accidentally take too many tablets, contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Irbesartan Teva, kot bi smeli Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte s svojim zdravnikom.
English: If you are more than 3 months pregnant (it is also better to avoid Irbesartan Teva in early pregnancy - see pregnancy section).
Slovenian: • če ste noseči dlje kot tri mesece (Jemanju zdravila Irbesartan Teva se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti).
English: if you are more than 3 months pregnant (it is also better to avoid Irbesartan Teva in early pregnancy - see pregnancy section).
Slovenian: • če ste noseči dlje kot tri mesece (Jemanju zdravila Irbesartan Teva se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti.
English: Not known: impaired renal function including cases of renal failure in patients at risk (see section 4.4) Reproductive system and breast disorders
Slovenian: motnje v delovanju ledvic, vključno s primeri odpovedi ledvic pri ogroženih bolnikih (glejte poglavje 4.4)
English: potassium supplements salt substitutes containing potassium potassium-sparing medicines (such as certain diuretics) medicines containing lithium
Slovenian: • dodatke kalija • nadomestke soli, ki vsebujejo kalij
English: Irbesartan Teva 75 mg film-coated tablets Irbesartan Teva 150 mg film-coated tablets Irbesartan Teva 300 mg film-coated tablets
Slovenian: Irbesartan Teva 75 mg filmsko obložene tablete Irbesartan Teva 150 mg filmsko obložene tablete Irbesartan Teva 300 mg filmsko obložene tablete
English: thrombocytopenia Immune system disorders Not known:
Slovenian: Bolezni imunskega sistema Neznana:
English: The “Irbesartan Diabetic Nephropathy Trial (IDNT)” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria.
Slovenian: Hipertenzija in sladkorna bolezen tipa II z ledvično boleznijo Preskušanje irbesartana pri diabetični nefropatiji -“Irbesartan Diabetic Nephropathy Trial" (IDNT) kaže, da irbesartan pri bolnikih s kronično ledvično insuficienco in izraženo proteinurijo zmanjša napredovanje ledvične bolezni.
English: In particular, they appeared less favourable in women and non-white subjects (see section 5.1).
Slovenian: In sicer, so bili videti manj ugodni pri ženskah in pri nebelcih.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'.
Slovenian: Zdravilo Irbesartan Teva vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na filmsko obloženo tableto, kar v bistvu pomeni
English: Contents of the pack and other information What Irbesartan Teva contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Irbesartan Teva Zdravilna učinkovina je irbesartan.
English: White to off white capsule shaped, film coated tablet.
Slovenian: Bele do belkaste filmsko obložene tablete v obliki kapsule.
English: A limited accumulation of irbesartan (18 %) in plasma was observed upon repeated once daily dosing.
Slovenian: Po ponavljajočem odmerjanju enkrat na dan so ugotovili omejeno kopičenje irbesartana (18 %) v plazmi.
English: Irbesartan 75 mg film-coated tablets are white to off white capsule shaped, film coated tablet.
Slovenian: Irbesartan Teva 75 mg filmsko obložene tablete: bele do belkaste filmsko obložene tablete v obliki kapsule.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Slovenian: Pri sočasni uporabi litija in zaviralcev angiotenzinske konvertaze poročajo o reverzibilnem povečanju serumske koncentracije litija in o toksičnosti.
English: No dose adjustment is necessary in patients with impaired renal function.
Slovenian: Bolnikom s prizadeto ledvično funkcijo odmerka ni treba prilagajati.
English: • Each Irbesartan Teva 75 mg film-coated tablet contains 75 mg irbesartan.
Slovenian: Ena Irbesartan Teva 75 mg filmsko obložena tableta vsebuje 75 mg irbesartana.
English: Each film-coated tablet contains 75 mg irbesartan
Slovenian: Ena filmsko obložena tableta vsebuje 75 mg irbesartana.
English: You must tell your doctor if you think that you are (or might become) pregnant.
Slovenian: Zdravniku morate povedati, če mislite, da ste noseči (ali bi lahko zanosili).
English: • Each Irbesartan Teva 300 mg film-coated tablet contains 300 mg irbesartan.
Slovenian: Ena Irbesartan Teva 300 mg filmsko obložena tableta vsebuje 300 mg irbesartana.
English: Irbesartan Teva 75 mg film-coated tablets
Slovenian: Irbesartan Teva 75 mg filmsko obložene tablete
English: Pharmachemie B.V. Swensweg 5
Slovenian: Madžarska Pharmachemie B.V.
English: Irbesartan 150 mg film-coated tablets are white to off white capsule shaped, film coated tablet.
Slovenian: Irbesartan Teva 150 mg filmsko obložene tablete: bele do belkaste filmsko obložene tablete v obliki kapsule.
English: Uncommon: sexual dysfunction
Slovenian: motnje spolnosti
English: Irbesartan Teva 75 mg film-coated tablets Irbesartan
Slovenian: Irbesartan Teva 75 mg filmsko obložene tablete irbesartan
English: Irbesartan Teva is used in adult patients to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
Slovenian: Irbesartan Teva uporabljamo pri odraslih bolnikih: • za zdravljenje visokega krvnega tlaka (esencialne hipertenzije).
English: Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Slovenian: Pri bolnikih, ki imajo zmanjšan volumen krvi in/ali pomanjkanje natrija zaradi intenzivnega zdravljenja z diuretiki, omejevanja vnosa soli s hrano, driske ali bruhanja, se lahko pojavi simptomatska hipotenzija, zlasti po prvem odmerku.
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: • Each Irbesartan Teva 150 mg film-coated tablet contains 150 mg irbesartan.
Slovenian: Ena Irbesartan Teva 150 mg filmsko obložena tableta vsebuje 150 mg irbesartana.
English: Each film-coated tablet contains 300 mg irbesartan
Slovenian: Ena filmsko obložena tableta vsebuje 300 mg irbesartana.
English: Each film-coated tablet contains 150 mg irbesartan
Slovenian: Ena filmsko obložena tableta vsebuje 150 mg irbesartana.
English: The decrease in blood pressure is dose-related for once a day doses with a tendency towards plateau at doses above 300 mg. Doses of 150-300 mg once daily lower supine or seated blood pressures at trough (i.e. 24 hours after dosing) by an average of 8-13/5-8 mm Hg (systolic/diastolic) greater than those associated with placebo.
Slovenian: Zmanjšanje krvnega tlaka je odvisno od odmerka pri enkratnih dnevnih odmerkih in s tendenco doseganja platoja pri odmerkih večjih od 300 mg. Enkratni dnevni odmerki 150-300 mg v povprečju vseskozi (npr. 24 ur po odmerku)
English: Irbesartan Teva 150 mg film-coated tablets
Slovenian: Irbesartan Teva 150 mg filmsko obložene tablete
English: Irbesartan Teva 300 mg film-coated tablets
Slovenian: Irbesartan Teva 300 mg filmsko obložene tablete
English: Irbesartan Teva is unlikely to affect your ability to drive or use machines.
Slovenian: Verjetnost, da bi zdravilo Irbesartan Teva vplivalo na sposobnost upravljanja vozil ali stojev, je majhna.
English: After the transitional period of 2 years, a limit for NDMA and NDEA of maximum 0.03 ppm should be implemented.
Slovenian: in N-nitrozodietilamin (NDEA) uvesti naslednje specifikacije za učinkovino: Po dveletnem prehodnem obdobju je treba za NDMA in NDEA uvesti mejo največ
English: Irbesartan
Slovenian: zlatenica
English: Mogilska 80
Slovenian: makrogol 4000
English: No dose adjustment is necessary in patients with mild to moderate hepatic impairment.
Slovenian: Bolnikom z lažjo do srednje težko jetrno okvaro odmerka ni treba prilagajati.
English: Other medicines and Irbesartan Teva
Slovenian: Možni neželeni učinki Shranjevanje zdravila Irbesartan Teva
English: Hypertensive patients with type 2 diabetes and renal disease The effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease.
Slovenian: Analiza rezultatov študije z bolniki z napredovalo ledvično boleznijo kaže, da učinki irbesartana tako na ledvične kot srčnožilne dogodke niso enotni znotraj podskupin.
English: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Slovenian: Renovaskularna hipertenzija Pri bolnikih z obojestransko stenozo ledvične arterije ali s stenozo arterije ene same delujoče ledvice,
English: orthostatic hypotension* Uncommon: flushing
Slovenian: ortostatska hipotenzija*
English: EU/1/09/576/025 50 x 1 tablet (unit dose) EU/1/09/576/026 56 x 1 tablet (unit dose) EU/1/09/576/041 28 tablets (calendar pack)
Slovenian: EU/1/09/576/025 50 x 1 tablet (enkratno odmerjanje) EU/1/09/576/026 56 x 1 tablet (enkratno odmerjanje) EU/1/09/576/041 28 tablet (koledarsko pakiranje)
English: Irbesartan 300 mg film-coated tablets are white to off white capsule shaped, film coated tablet.
Slovenian: Izgled zdravila Irbesartan Teva in vsebina pakiranja Irbesartan Teva 300 mg filmsko obložene tablete: bele do belkaste filmsko obložene tablete v obliki kapsule.
English: EU/1/09/576/038 50 x 1 tablet (unit dose) EU/1/09/576/039 56 x 1 tablet (unit dose) EU/1/09/576/042 28 tablets (calendar pack)
Slovenian: EU/1/09/576/038 50 x 1 tablet (enkratno odmerjanje) EU/1/09/576/039 56 x 1 tablet (enkratno odmerjanje) EU/1/09/576/042 28 tablet (koledarsko pakiranje)
English: Package leaflet: information for the user Irbesartan Teva 150 mg Film-Coated Tablets
Slovenian: PODATKI V BRAILLOVI PISAVI Irbesartan Teva 150 mg filmsko obložene tablete
English: Package leaflet: information for the user Irbesartan Teva 300 mg Film-Coated Tablets
Slovenian: PODATKI V BRAILLOVI PISAVI Irbesartan Teva 300 mg filmsko obložene tablete
English: For N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) the MAH must introduce the following specifications for the drug substance:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora za N-nitrozodimetilamin (NDMA)
English: Therefore, the use of irbesartan is not recommended.
Slovenian: V zgodnjem obdobju nosečnosti uporaba zdravila Irbesartan Teva ni priporočljiva.
English: Povidone
Slovenian: Preiskave
English: Respiratory, thoracic and mediastinal disorders Uncommon: cough
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Občasni:
English: In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Slovenian: Pri bolnikih z visokim krvnim tlakom in sladkorno boleznijo tipa 2 zdravilo Irbesartan Teva upočasni pešanje delovanja ledvic.
English: Package leaflet: information for the user Irbesartan Teva 75 mg Film-Coated Tablets
Slovenian: PODATKI V BRAILLOVI PISAVI Irbesartan Teva 75 mg filmsko obložene tablete
English: Because no information is available regarding the use of irbersartan during breast-feeding, irbesartan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Slovenian: Priporočajo se alternativni načini zdravljenja s potrjeno varnostjo pri doječih materah, še zlasti pri dojenju novorojenčkov ali nedonošenčkov.
English: EU/1/09/576/012 50 x 1 tablet (unit dose) EU/1/09/576/013 56 x 1 tablet (unit dose) EU/1/09/576/040 28 tablets (calendar pack)
Slovenian: EU/1/09/576/012 50 x 1 tablet (enkratno odmerjanje) EU/1/09/576/013 56 x 1 tablet (enkratno odmerjanje)
English: Common (may affect up to 1in 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme).
Slovenian: Krvne preiskave lahko pokažejo zvišanje vrednosti encima, ki kaže na delovanje mišic in srca (encim kreatin-kinaza).
English: OTHER
Slovenian: II.
English: hyperkalaemia Nervous system disorders Common:
Slovenian: Bolezni živčevja Pogosti:
English: Your doctor will advise you.
Slovenian: Zdravnik vam bo svetoval.
English: The dose is 0.5 ml.
Slovenian: Odmerek je 0,5 ml.
English: Adolescents and adults
Slovenian: Mladostniki in odrasli
English: After the Commission decision the Member State competent authorities, in liaison with the reference Member State, will update the product information as required.
Slovenian: Po odločbi komisije bodo pristojni organi držav članic v povezavi z referenčno državo članico posodobili informacije o zdravilu, kot bo potrebno.
English: In controlled clinical studies, signs and symptoms were actively monitored during a 42-day follow-up period.
Slovenian: V nadzorovanih kliničnih študijah so znake in simptome aktivno spremljali med 42-dnevnim opazovalnim obdobjem.
English: Because these adverse reactions were reported spontaneously, it is not possible to reliably estimate their frequency.
Slovenian: Ker so o teh dogodkih poročali spontano, njihove pogostnosti ni mogoče zanesljivo oceniti.
English: Your doctor will advise if additional doses of vaccine are needed.
Slovenian: Vaš zdravnik vam bo svetoval, ali so potrebni dodatni odmerki cepiva.
English: A second dose should be given according to official recommendations.
Slovenian: Drugi odmerek je treba dati v skladu z uradnimi priporočili.
English: Inject the entire content of the vial.
Slovenian: Injicirajte celotno vsebino viale.
English: The vaccinees were also requested to report any clinical events during the study period.
Slovenian: Cepljene osebe so tudi prosili, da med obdobjem študije poročajo o vsakem kliničnem dogodku.
English: • loss of appetite
Slovenian: • izguba apetita;
English: Dispose of in accordance with local regulations
Slovenian: Odstranite v skladu z lokalnimi predpisi.
English: Immediate measures depend on the severity of the reaction (see section 4.4).
Slovenian: Takojšnje ukrepanje je odvisno od resnosti reakcije (glejte poglavje 4.4).