FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/09/577/001 1 prefilled syringe with needle EU/1/09/577/002 10 prefilled syringes with needle EU/1/09/577/005 1 prefilled syringe without needle EU/1/09/577/006 10 prefilled syringes without needle
Slovenian: EU/1/09/577/001 1 napolnjena injekcijska brizga z iglo EU/1/09/577/002 10 napolnjenih injekcijskih brizg z iglo EU/1/09/577/005 1 napolnjena injekcijska brizga brez igle EU/1/09/577/006 10 napolnjenih injekcijskih brizg brez igle
English: What Foclivia is and what it is used for What you need to know before you receive Foclivia How Foclivia is given
Slovenian: Kaj je zdravilo Foclivia in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Foclivia Kako uporabljati zdravilo Foclivia
English: Your doctor needs to assess the benefits and potential risks of giving you the vaccine.
Slovenian: Zdravnik mora oceniti koristi in možno tveganje zaradi cepiva.
English: A dose (0.5 ml) of the vaccine will be injected into the upper arm (deltoid muscle).
Slovenian: Odmerek (0,5 ml) cepiva vam bodo injicirali v zgornji del roke (deltoidno mišico).
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Slovenian: Znaki alergijske reakcije lahko vključujejo srbečo kožo, zasoplost, otekanje obraza ali jezika.
English: Two doses of 7.5 micrograms were administered three weeks apart and a third dose 12 months following the first dose.
Slovenian: V presledku treh tednov so dali dva odmerka po 7,5 mikrograma in tretji odmerek 12 mesecev po prvem odmerku.
English: Serum samples were tested against the original H5N3 and also a number of H5N1 isolates.
Slovenian: Vzorce seruma so preizkusili proti izvirnemu izolatu H5N3 in proti številnim izolatom H5N1.
English: There is limited experience for the booster dose in the elderly population.
Slovenian: Izkušnje za obnovitveni odmerek pri starejši populaciji so omejene.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this vaccine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali medicinsko sestro, preden se cepite s tem cepivom.
English: Reactogenicity after a third dose, administered 12 months after the second dose, was higher than after both first and second dose.
Slovenian: Reaktogenost po tretjem odmerku, ki je bil dan 12 mesecev po drugem odmerku, je bila večja kot po prvem in drugem odmerku.
English: Foclivia is a milky-white liquid.
Slovenian: Zdravilo Foclivia je mlečno bela tekočina.
English: Adverse reactions from clinical trials with the pandemic preparedness vaccine Foclivia are listed below.
Slovenian: Neželeni učinki v kliničnih preskušanjih s cepivom Foclivia za pripravljenost na pandemijo so navedeni spodaj.
English: Health care providers need to assess the benefits and potential risks of administering Foclivia vaccine to pregnant women, taking into consideration official recommendations.
Slovenian: Zdravnik mora presoditi koristi in možno tveganje uporabe zdravila Foclivia pri nosečnicah, pri čemer mora upoštevati uradna priporočila.
English: Rare (>1/10,000, <1/1,000): Thrombocytopenia (some very rare cases were severe with platelet counts less than 5.000 per mm3).
Slovenian: Redki (> 1/10.000, < 1/1.000): Trombocitopenija (nekaj zelo redkih primerov s številom trombocitov pod 5.000 na mm3).
English: Foclivia should not be given at the same time as other vaccines (if another vaccine is required at the same time, then the injection should be carried out on a different limb.
Slovenian: Zdravilo Foclivia se ne sme dajati sočasno z drugimi cepivi (če je sočasno cepljenje z drugim cepivom nujno, ga je treba injicirati v drugo okončino.
English: This section describes the clinical experience with the H5N1 pandemic preparedness vaccines following a two-dose administration of 7.5 microgram.
Slovenian: V tem poglavju so opisane klinične izkušnje s cepivi proti H5N1 za pripravljenost na pandemijo po uporabi dveh odmerkov cepiva 7,5 mikrogramov.
English: Adjuvant: MF59C.1 oil in water emulsion containing squalene, as the oil phase, stabilised with polysorbate 80 and sorbitan trioleate in a citrate buffer (sodium citrate, citric acid).
Slovenian: Adjuvans: MF59C.1 emulzija olja v vodi, ki vsebuje skvalen kot oljno fazo in je stabilizirana s polisorbatom 80 in sorbitantrioleatom v citratnem pufru (natrijev citrat, citronska kislina).
English: Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems) and exudative Stevens-Johnson syndrome (erythema multiforme).
Slovenian: Vaskulitis (vnetje krvnih žil, ki lahko povzroči kožne izpuščaje, bolečine v sklepih in težave z ledvicami) in eksudativni Stevens-Johnsonov sindrom (multiformni eritem).
English: Seroprotection rate (95% CI) Day 43 Seroconversion factor (95% CI) Day 43 to Day 1 Seroconversion rate (95% CI) Day 43 * In the absence of CHMP immunogenicity criteria for children, the CHMP immunogenicity criteria used to evaluate seasonal flu vaccines in adults were applied to the serological data obtained after vaccination of children.
Slovenian: 43. dan Faktor serokonverzije (95-odstotni IZ) 43. dan do 1. dan Stopnja serokonverzije (95-odstotni IZ) 43. dan * V odsotnosti kriterijev CHMP za imunogenost za otroke so bili za oceno seroloških podatkov po cepljenju otrok uporabljeni kriteriji CHMP za imunogenost za oceno sezonskih cepiv proti gripi za odrasle.
English: Adults and elderly (above 18 years old).
Slovenian: Odrasli in starejši (starejši od 18 let):
English: Although Foclivia in multidose vials contains a preservative that inhibits microbial growth, minimisation of the risk of contamination of the multidose vial during withdrawal of each dose is the responsibility of the user.
Slovenian: Foclivia v večodmernih vialah vsebuje konzervans, ki zavira rast mikrobov, je uporabnik odgovoren za zmanjšanje tveganja kontaminacije večodmerne viale med odvzemom vsakega odmerka.
English: First dose
Slovenian: Prvi odmerek
English: When a person is given the vaccine, the body's natural defence system (immune system) produces its own protection (antibodies) against the disease.
Slovenian: Po cepljenju naravni obrambni sistem telesa (imunski sistem) napravi zaščito (protitelesa) proti bolezni.
English: After 3 weeks from the 2nd vaccination (day 43) all age groups (i.e. 6-35 months, 3-8 years and 9-17 years) achieved high levels of antibodies to (A/Vietnam/1194/2004) as evaluated with SRH and HI assays as presented in table below*.
Slovenian: Po 3 tednih od 2. cepljenja (43. dan) so vse starostne skupine (tj. 6-35 mesecev, 3-8 let in 9-17 let) dosegle visoko raven protiteles na sev (A/Vietnam/1194/2004), ocenjeno s testoma SRH in HI, kot je predstavljeno v spodnji preglednici*.
English: The European Medicines Agency (EMA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Slovenian: Evropska agencija za zdravila (EMA) bo vsako leto ponovno pregledala vse nove podatke o tem zdravilu.
English: Some cases were observed in subjects with a history of epilepsy.
Slovenian: Nekaj primerov so ugotovili pri osebah z epilepsijo v anamnezi.
English: Data obtained with a pandemic preparedness vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical efficacy and safety data obtained with pandemic preparedness vaccines are relevant for the pandemic vaccines.
Slovenian: Podatki, pridobljeni z uporabo cepiva za pripravljenost na pandemijo, bodo podprli strategijo cepljenja, ki se bo verjetno uporabila za cepivo proti pandemični gripi: podatki o klinični učinkovitosti in varnosti, pridobljeni s cepivi za pripravljenost na pandemijo, veljajo za cepiva proti pandemični gripi.
English: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Slovenian: Po cepljenju ali celo pred cepljenjem se lahko pojavi sinkopa (omedlevica) kot psihogeni odziv na injekcijsko iglo.
English: Packs of 1 and 10 with or without needle.
Slovenian: Pakiranja po 1 in 10 injekcijskih brizg z iglo ali brez nje.
English: Foclivia should not be given at the same time as other vaccines.
Slovenian: Zdravila Foclivia se ne sme dajati sočasno z drugimi cepivi.
English: - Periodicity should be reviewed by the MAH and the (Co-)Rapporteur at 6 monthly intervals.
Slovenian: - Imetnik dovoljenja za promet z zdravilom in (so-)poročevalec bosta ocenila periodičnost v šestmesečnih presledkih.
English: The doctor should inform you about the posibility to experience convulsion, in particular if you have had previous history of epilepsy.
Slovenian: Zdravnik vas bo obvestil o možnosti pojava epileptičnih krčev, zlasti če ste ga v preteklosti že imeli.
English: Important information about some of the ingredients of Foclivia Foclivia contains thiomersal
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Foclivia Zdravilo Foclivia vsebuje tiomersal
English: Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Slovenian: Po cepljenju proti gripi se lahko pojavijo lažno pozitivni serološki testi z metodo ELISA za določanje protiteles proti humanemu virusu imunske pomanjkljivosti (HIV-1), virusu hepatitisa C in zlasti virusu HTLV-1.
English: Cross reactivity
Slovenian: Navzkrižne reakcije
English: Please inform your doctor or nurse if you have a bleeding problem or bruise easily.
Slovenian: Obvestite zdravnika ali medicinsko sestro, če imate težave s strjevanjem krvi ali če ste nagnjeni k podplutbam.
English: These antigens can be considered as ‘novel' antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Slovenian: Ti antigeni delujejo kot „novi“ antigeni in posnemajo stanje, pri katerem ciljna populacija še ni bila cepljena.
English: Prophylaxis of influenza in an officially declared pandemic situation.
Slovenian: Profilaksa influence pri uradno razglašeni pandemiji.
English: Like all medicines, Foclivia can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Foclivia neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: H5N1 adjuvanted vaccine
Slovenian: Cepivo H5N1 z adjuvansom
English: Syringes without needle are fitted with a Luer Lock system.
Slovenian: Injekcijske brizge brez igle so opremljene s sistemom luer-lock.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALEC (IZDELOVALCI),
English: Immunisation should be carried out by intramuscular injection into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Slovenian: Imunizacijo je treba opraviti z intramuskularnim injiciranjem v deltoidno mišico ali anterolateralni predel stegna (odvisno od mišične mase).
English: What you need to know before you receive Foclivia Foclivia should not be given if you:
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Foclivia Zdravila Foclivia ne smete prejeti, če:
English: - Vasculitis:
Slovenian: - Vaskulitis:
English: Foclivia is a vaccine intended to be given to prevent influenza (flu) in an officially declared pandemic.
Slovenian: Zdravilo Foclivia je cepivo, ki je namenjeno dajanju za preprečevanje gripe v uradno razglašenih pandemičnih razmerah.
English: Postmarketing spontaneously reported adverse events and an interventional study do not suggest direct or indirect harmful effects of Focetria exposure on pregnancy.
Slovenian: Neželeni učinki, zabeleženi v obdobju trženja zdravila in v intervencijski študiji, ne nakazujejo neposrednih ali posrednih škodljivih učinkov izpostavite zdravilu Focetria na nosečnost.
English: In addition, two large observational studies designed to assess the safety of Focetria exposure in pregnancy showed no increase in the rates of gestational diabetes, preeclampsia, abortions, stillbirth, low birth weight, prematurity, neonatal deaths, and congenital malformations among almost 10.000 vaccinated pregnant women and their offspring compared with unvaccinated controls.
Slovenian: Poleg tega sta bili izvedeni dve veliki opazovalni študiji za oceno varnosti izpostavitve zdravilu Focetria v nosečnosti, v katerih pri skoraj 10.000 cepljenih nosečnicah in njihovih otrocih v primerjavi z necepljenimi kontrolnimi osebami niso dokazali povečanih stopenj gestacijske sladkorne bolezni, preeklampsije, splavov,
English: Very common reactions reported in 146 infants and toddlers 6 to 35 months of age: Tenderness, erythema, irritability, unusual crying, sleepiness, diarrhoea, vomiting and change in eating habits.
Slovenian: Zelo pogosti neželeni učinki, ugotovljeni pri 146 dojenčkih in malčkih, starih od 6 do 35 mesecev: občutljivost na dotik, eritem, razdražljivost, neobičajno jokanje, zaspanost, driska, bruhanje in sprememba prehranjevalnih navad.
English: * measured by SRH assay ≥ 25 mm2 ** geometric mean ratios of SRH
Slovenian: * izmerjeno s testom SRH ≥ 25 mm2 ** razmerja geometričnih povprečij za SRH
English: Do not use Foclivia after the expiry date which is stated on the carton and the label after EXP.
Slovenian: Zdravila Foclivia ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in ovojnini poleg oznake „Uporabno do/Upor.
English: - Convulsion:
Slovenian: - Konvulzije:
English: Record date and time of the first dose withdrawal on the vial label.
Slovenian: Na nalepko viale zabeležite datum in uro prvega odvzema odmerka.
English: Foclivia should under no circumstances be administered intravascularly or subcutaneously.
Slovenian: Zdravilo Foclivia se v nobenem primeru ne sme dajati intravaskularno ali subkutano.
English: Frequency of Adverse reactions in clinical trials and postmarketing surveillance is reported hereunder.
Slovenian: V nadaljevanju je prikazana pogostnost neželenih učinkov v kliničnih preskušanjih in pri nadzoru v obdobju trženja zdravila.
English: It is widely accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional, nonadjuvanted influenza vaccines.
Slovenian: Splošno sprejeto je, da učinek adjuvansa privede do večje imunogenosti, ki je povezana z rahlo večjo pogostnostjo lokalnih reakcij (večinoma blaga bolečina) kot pri običajnih cepivih proti gripi brez adjuvansa.
English: Across all ages, low percentages of subjects reported fever.
Slovenian: V vseh starostnih skupinah je majhen delež oseb navedel zvišano telesno temperaturo.
English: In some cases the effects may also include raised temperature, malaise (generally feeling unwell), shivering, tiredness, headache, sweating, pain in muscles and joints.
Slovenian: V nekaterih primerih so učinki lahko tudi zvišana telesna temperatura, slabotnost (splošno slabo počutje), tresenje, utrujenost, glavobol, potenje, bolečine v mišicah in sklepih.
English: Immunogenicity results with Focetria H1N1v (Study V111_03):
Slovenian: Rezultati imunogenosti z zdravilom Focetria H1N1v (študija V111_03):
English: Children (3-<9 years)
Slovenian: Otroci (3-<9 let)
English: Any adverse reaction Local
Slovenian: Vsi neželeni učinki Lokalni
English: 0.04 milligrams
Slovenian: 0,04 miligramov
English: Cardiac disorders Palpitation, tachycardia.
Slovenian: Srčne bolezni palpitacije, tahikardija
English: The vaccine should not be administered intravascularly or subcutaneously.
Slovenian: Cepivo se ne sme dajati intravaskularno ali subkutano.
English: Elderly (>60 years)
Slovenian: Starejši (> 60 let)
English: It is widely accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional,
Slovenian: Splošno sprejeto je, da učinek adjuvansa privede do večje imunogenosti, ki je povezana z rahlo večjo pogostnostjo lokalnih reakcij (večinoma blaga bolečina)
English: In some cases the effects may also include raised temperature, malaise (generally feeling unwell), shivering,
Slovenian: V nekaterih primerih so učinki lahko tudi zvišana telesna temperatura, slabotnost (splošno slabo počutje),
English: From the clinical trials conducted with the pandemic preparedness adjuvanted H5N1 vaccine in adult and elderly (see section 5.1 for more information), most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines.
Slovenian: V kliničnih preskušanjih, opravljenih s cepivom proti gripi H5N1 za pripravljenost na pandemijo z dodanim adjuvansom pri odraslih in starejših (za več informacij glejte poglavje 5.1), je bilo največ neželenih učinkov blage narave s kratkih trajanjem in kvalitativno podobnih neželenim učinkom običajnih cepiv proti sezonski gripi.
English: Persistence of antibodies after primary vaccination in this population was assessed by Hemagglutination Inhibition (HI), SRH, and MN assays.
Slovenian: Obstojnost protiteles po primarnem cepljenju v tej populaciji je bila ocenjena s testi zaviranja hemaglutinacije (HI - hemagglutination inhibition), SRH in MN.
English: Data in children and adolescents 3-17 years suggest a slight decrease in reactogenicity after the second dose, with no increase in rates of fever.
Slovenian: Podatki, pridobljeni pri otrocih in mladostnikih, starih 3-17 let, nakazujejo manjši upad reaktogenosti po drugem odmerku brez povečanja pogostnosti stopenj zvišane telesne temperature.
English: Second dose (21 days after first dose)
Slovenian: Drugi odmerek (21 dni po prvem odmerku)
English: 5 ml vial containing 10 doses (0.5 ml/dose)
Slovenian: 5-mililitrska viala, ki vsebuje 10 odmerkov (0,5 ml/odmerek)
English: The European Medicines Agency (EMA) will review any new information which may become available every year and this SmPC will be updated as necessary.
Slovenian: Evropska agencija za zdravila (EMA) bo vsako leto pregledala vse nove podatke, ki bodo na voljo.
English: Blood and lymphatic system disorders Lymphadenopathy.
Slovenian: Bolezni krvi in limfatičnega sistema limfadenopatija
English: Numbness or tingling sensations, involuntary muscle contractions or thrombocytopenia (reduction in the number of certain types of particles in the blood called plateles; a low number of these can result in excessive bruising or bleeding).
Slovenian: Občutek otrplosti ali mravljinčenja, nenadzorovano krčenje mišic ali trombocitopenija (zmanjšano število krvnih celic, imenovanih krvne ploščice; nizko število lahko povzroči čezmerne modrice ali krvavitve).
English: Toddlers (6-<36 months)
Slovenian: Malčki (6-<36 mesecev)
English: Infants (6 to 11 months of age)
Slovenian: Dojenčki (stari od 6 do 11 mesecev)
English: Regardless of age, reactogenicity was higher after the first dose than after the second vaccination.
Slovenian: Po prvem odmerku je bila reaktogenost večja kot po drugem odmerku ne glede na starost.
English: Once the needle is locked in place, remove the needle protector and administer the vaccine.
Slovenian: Ko se igla zaskoči, odstranite ščitnik igle in aplicirajte cepivo.
English: The European medicines Agency has deferred the obligation to submit the results of studies with Foclivia in one or more subsets of the paediatric populations in active immunisation against H5N1 subtype of Influenza A virus.
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Foclivia za eno ali več podskupin pediatrične populacije za aktivno imunizacijo proti podtipu H5N1 virusa influence A. Za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2.
English: Data in infants and toddlers 6-35 months of age suggest a slight decrease in reactogenicity after the second dose, with no increase in rates of fever.
Slovenian: Podatki, pridobljeni pri dojenčkih in malčkih, starih 6-35 mesecev, nakazujejo manjši upad reaktogenosti po drugem odmerku brez povečanja pogostnosti stopenj zvišane telesne temperature.
English: Allergic reactions, anaphylaxis including dyspnoea, bronchospasm, laryngeal oedema, in rare cases leading to shock.
Slovenian: Bolezni imunskega sistema alergijske reakcije, anafilaksa, vključno z dispnejo, bronhospazem, laringialni edem, ki v redkih primerih vodijo v šok
English: Very common reactions reported in children and adolescents 3 to 17 years of age: Pain, induration and erythema, malaise, myalgia, headache and fatigue.
Slovenian: Zelo pogosti neželeni učinki, ugotovljene pri otrocih in mladostnikih, starih od 3 do 17 let: bolečina, induracija in eritem, splošno slabo počutje, mialgija, glavobol in utrujenost.
English: Third dose (12 months after second dose)
Slovenian: Tretji odmerek (12 mesecev po drugem odmerku)
English: Serologic responses obtained with the SRH assay showed that 100% of subjects achieved seroprotection and 100% seroconverted after two 7.5 µg injections.
Slovenian: Serološki odziv, pridobljen z metodo SRH, je pokazal, da je do serološke zaščite prišlo pri 100 % oseb in da se je po dveh 7,5-mikrogramskih injekcijah pri 100 % pojavila serološka konverzija.
English: The active ingredients of the vaccine are purified viral proteins (called haemagglutinin and neuraminidase).
Slovenian: Učinkovini cepiva sta prečiščeni virusni beljakovini (imenovani hemaglutinin in nevraminidaza).
English: When using a pre-filled syringe without a needle supplied with a Luer Lock system, remove the tip cap by unscrewing it in a counter-clockwise direction.
Slovenian: Če uporabljate napolnjeno injekcijsko brizgo brez igle, opremljeno s sistemom luer-lock, odstranite pokrovček konice, tako da jo odvijete v nasprotni smeri ure.
English: In children and adolescents pain was the most frequently reported solicited local reaction, and fatigue and headache were the most commonly reported solicited systemic reactions.
Slovenian: Pri otrocih in mladostnikih je bila bolečina in najpogostejša izzvana lokalna reakcija, utrujenost in glavobol pa najpogostejši izzvani sistemski reakciji.
English: Breast-feeding The vaccine may be used during lactation.
Slovenian: Dojenje Cepivo se lahko uporablja med dojenjem.
English: ** geometric mean ratios of SRH ° measured by HI assay ≥ 40 °° geometric mean ratios of HI *** In V87P1: baseline not tested
Slovenian: * izmerjeno s testom SRH ≥ 25 mm2 ** razmerja geometričnih povprečij za SRH ° izmerjeno s testom ≥ 40 °° razmerja geometričnih srednjih vrednosti za HI *** v V87P1: izhodišče ni bilo testirano
English: Safety data after the first and second dose in children and adolescents with a similar pandemic vaccine (Focetria H1N1v) suggest a comparable safety profile with that reported for the aH5N1 pandemic preparedness vaccine formulation (Foclivia).
Slovenian: Varnostni podatki po prvem in drugem odmerku pri otrocih in mladostnikih s podobnim cepivom (Focetria H1N1v) kažejo varnostni profil, ki je primerljiv z varnostnim profilom cepiva proti aH5N1 za pripravljenost na pandemijo (Foclivia).
English: The vaccine may be used during lactation.
Slovenian: Cepivo se lahko uporabi v obdobju dojenja.
English: Induration and ecchymosis were very common reactions in toddlers but were less common in infants.
Slovenian: Induracija in ekhimoza sta bila zelo pogosta neželena učinka pri malčkih, vendar manj pogosta pri dojenčkih.
English: Adverse event(s) from post-marketing surveillance with the pandemic vaccine: not applicable.
Slovenian: Neželeni učinek (učinki) iz postmarketinškega nadzora cepiva proti pandemični gripi: navedba smiselno ni potrebna.