FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, dose intervals of less than 4 weeks should be avoided.
Croatian: Stoga treba izbjegavati vremenske razmake između doza manje od 4 tjedna.
English: If you are a pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask to your doctor for advice.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet.
English: Individuals with atopic dermatitis (AD)
Croatian: Osobe s atopijskim dermatitisom (AD)
English: Primary immunisation
Croatian: Primarna imunizacija
English: This means that because of scientific reasons it has been impossible to get complete information on this medicine.
Croatian: To znači da zbog znanstvenih razloga nije bilo moguće dobiti potpune informacije o ovom lijeku.
English: • pink eye,
Croatian: • crveno oko,
English: Denmark tel fax +45 3326 8380 e-mail regulatory@bavarian-nordic.com
Croatian: Danska tel fax +45 3326 8380 e-mail regulatory@bavarian-nordic.com
English: Immunisation should be postponed in individuals suffering from an acute severe febrile illness or acute infection.
Croatian: Imunizaciju treba odgoditi u osoba koje boluju od teške akutne febrilne bolesti ili akutne infekcije.
English: Pack size of 20.
Croatian: Veličina pakiranja od 20.
English: Other medicines or vaccines and IMVANEX
Croatian: Drugi lijekovi ili cjepiva i IMVANEX
English: Status to be reported annually within each annual reassessment application
Croatian: O stanju treba izvještavati svake godine u sklopu svakog godišnjeg zahtjeva za ponovnu procjenu
English: • You will receive one injection.
Croatian: • Primit ćete jednu injekciju.
English: Contact a doctor immediately, or go immediately to the emergency department of your nearest hospital if you experience any of the following symptoms:
Croatian: Ozbiljne nuspojave Odmah obavijestite liječnika ili odmah otiđite na hitnu službu najbliže bolnice ako dobijete neki od sljedećih simptoma:
English: Non-clinical data reveal no special hazard for humans based on repeated dose toxicity, local tolerance, female fertility, embryo-foetal and postnatal toxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti ponovljenih doza, lokalne podnošljivosti, ženske plodnosti, embriofetalne i postnatalne toksičnosti.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke u smislu reproduktivne toksičnosti (vidjeti dio 5.3).
English: The use of this vaccine during pregnancy and breast-feeding is not recommended.
Croatian: Ne preporučuje se primjena ovog cjepiva tijekom trudnoće i dojenja.
English: • loss of appetite,
Croatian: • gubitak apetita,
English: Most of them were mild to moderate in nature and resolved without any treatment within seven days.
Croatian: Većina su bile blage do umjerene naravi i povukle su se bez ikakvog liječenja u roku od sedam dana.
English: The presence of a minor infection, such as a cold, should not require postponement of the vaccination, but talk to your doctor or nurse first.
Croatian: Prisutnost manje infekcije, kao što je prehlada, nije razlog za odgađanje cijepljenja, ali prvo razgovarajte sa svojim liječnikom ili medicinskom sestrom.
English: Talk to your doctor or nurse before receiving IMVANEX:
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije primanja cjepiva IMVANEX:
English: Individuals with atopic dermatitis developed more local and general symptoms after vaccination (see section 4.8)
Croatian: Osobe s atopijskim dermatitisom razvile su više lokalnih i općih simptoma nakon cijepljenja (vidjeti dio 4.8).
English: • You will receive two injections.
Croatian: • Primit ćete dvije injekcije.
English: Pharmacotherapeutic group: Vaccine, other viral vaccines, ATC code: J07BX
Croatian: Farmakoterapijska skupina: cjepivo, druga virusna cjepiva, ATK oznaka: J07BX
English: Immunogenicity and attenuation of take of ACAM2000 in healthy subjects
Croatian: Imunogenost i atenuacija plika uzrokovanog ACAM2000 u zdravih ispitanika
English: • Make sure you complete the vaccination course of two injections.
Croatian: • Pazite da dovršite ciklus cijepljenja od dvije injekcije.
English: • if you have atopic dermatitis (see section 4).
Croatian: • ako imate atopijski dermatitis (vidjeti dio 4).
English: However, your doctor will assess whether the possible benefit in terms of preventing smallpox would outweigh the potential risks of giving you this vaccine.
Croatian: Međutim, Vaš će liječnik procijeniti je li moguća korist u smislu sprječavanja velikih boginja veća od mogućih rizika davanja ovog cjepiva.
English: Booster Dose
Croatian: Booster doza
English: 20 single dose vials.
Croatian: 20 jednodoznih bočica.
English: The most common side effects reported were at the site of injection.
Croatian: Najčešće zabilježene nuspojave bile su na mjestu injiciranja.
English: Adverse reaction rates reported after either vaccination dose (1st, 2nd or booster) were similar.
Croatian: Učestalost nuspojava prijavljenih nakon bilo koje doze cjepiva (1., 2. ili booster) bile su slične.
English: No interaction studies with other vaccines or medicinal products have been performed.
Croatian: Nisu provedena ispitivanja interakcija s drugim cjepivima ili lijekovima.
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection in the form of antibodies against the smallpox virus.
Croatian: Kada neka osoba primi ovo cjepivo, imunološki sustav (prirodni obrambeni sustav u tijelu) stvorit će vlastitu zaštitu u obliku protutijela protiv virusa velikih boginja.
English: If you already have atopic dermatitis, you may experience more intense local skin reactions (such as redness, swelling and itching) and other general symptoms (such as headache, muscle pain, feeling sick or tired), as well as a flare-up or worsening of your skin condition.
Croatian: Ako već imate atopijski dermatitis, možete razviti jače lokalne kožne reakcije (kao što su crvenilo, oticanje i svrbež) i druge opće simptome (kao što je glavobolja, bol u mišićima, mučnima i umor), kao i rasplamsavanje ili pogoršanje Vaše kožne bolesti.
English: IMVANEX may trigger local rashes or more widespread eruptions.
Croatian: IMVANEX može potaknuti nastanak lokalnih osipa ili proširenijih kožnih erupcija.
English: IMVANEX is available in pack containing 20 vials.
Croatian: IMVANEX je dostupan u pakiranju koje sadrži 20 bočica.
English: There are no data on the immune response to IMVANEX in other immunosuppressed individuals.
Croatian: Nema podataka o imunološkom odgovoru na IMVANEX u drugih imunokompromitiranih osoba.
English: The safety and efficacy of IMVANEX in children below 18 years have not been established.
Croatian: Sigurnost i djelotvornost cjepiva IMVANEX u djece u dobi do 18 godina nisu ustanovljene.
English: • if you have HIV infection or any other condition or treatment leading to a weakened immune system.
Croatian: • ako imate HIV-infekciju ili neku drugu bolest ili primate liječenje, koji mogu dovesti do slabljenja imunološkog sustava
English: Thaw at room temperature.
Croatian: Odmrznuti na sobnoj temperaturi.
English: • if you have previously had a sudden life-threatening allergic reaction to any ingredient of Imvanex (these are listed in section 6) or chicken protein, benzonase or gentamicin which may be present in the vaccine in very small amounts.
Croatian: • ako ste prethodno imali iznenadnu životno opasnu alergijsku reakciju na bilo koji sastojak cjepiva Imvanex (navedeni su u dijelu 6) ili pileći protein, benzonazu ili gentamicin koji mogu biti prisutni u cjepivu u vrlo malim količinama.
English: If you miss a scheduled injection, tell your doctor or nurse and arrange another visit.
Croatian: Ako propustite planiranu injekciju, obavijestite liječnika ili medicinsku sestru i dogovorite sljedeći posjet.
English: 0.5 ml suspension in a vial (Type I glass) with stopper (bromobutyl rubber).
Croatian: 0,5 ml suspenzije u bočici (staklo tipa I) s čepom (bromobutilna guma).
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT • Risk Management Plan (RMP)
Croatian: • Plan upravljanja rizikom (RMP)
English: The concomitant administration of the vaccine with any immunoglobulin including Vaccinia Immune Globulin (VIG) has not been studied and should be avoided.
Croatian: Istovremena primjena cjepiva s bilo kojim imunoglobulinom, uključujući imunoglobulin vakcinije (VIG) nije ispitana i treba je izbjegavati.
English: Data have been generated in HIV infected individuals with CD4 counts ≥ 100 cells/µl and ≤ 750 cells/µl.
Croatian: Dobiveni su podaci za osobe zaražene HIV-om s brojem CD4 ≥ 100 stanica/µl i ≤ 750 stanica/µl.
English: IMVANEX does not contain smallpox virus (Variola) and cannot spread or cause smallpox.
Croatian: IMVANEX ne sadrži virus velikih boginja (Variola) i ne može se proširiti niti izazvati velike boginje.
English: Long-term immunogenicity in humans
Croatian: Dugotrajna imunogenost u ljudi
English: • sweating,
Croatian: • znojenje,
English: It must not be injected into a blood vessel.
Croatian: Cjepivo se ne smije ubrizgati u krvnu žilu.
English: If a booster dose is considered necessary then a single dose of 0.5 ml should be administered.
Croatian: Ako se smatra da je docjepljivanje neophodno, onda treba primijeniti jednu dozu od 0,5 ml.
English: Expiry date depends on storage temperature.
Croatian: Rok valjanosti ovisi o temperaturi čuvanja.
English: Swirl the vial gently before use for at least 30 seconds.
Croatian: Nježno vrtite bočicu prije uporabe najmanje 30 sekundi.
English: Active immunisation against smallpox in adults (see sections 4.4 and 5.1).
Croatian: Aktivna imunizacija odraslih protiv velikih boginja (vidjeti dijelove 4.4 i 5.1).
English: IMVANEX is provided as a suspension for injection in a vial (0.5 ml).
Croatian: IMVANEX se isporučuje kao suspenzija za injekciju u bočici (0,5 ml).
English: Animal studies did not reveal any evidence of impaired female and male fertility.
Croatian: Ispitivanja na životinjama nisu pokazala smanjenje plodnosti ženki i mužjaka.
English: The presence of a minor infection and/or low-grade fever should not result in the deferral of vaccination.
Croatian: Prisutnost manje infekcije i/ili slabe vrućice ne bi trebala biti razlog za odgađanje cijepljenja.
English: The other ingredients are: trometamol, sodium chloride, and water for injections.
Croatian: Drugi sastojci su: trometamol, natrijev klorid i voda za injekcije.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 20 VIALS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE OD 20 BOČICA
English: Visually inspect the suspension prior to administration.
Croatian: Prije primjene vizualno pregledajte suspenziju.
English: 3 Per Protocol Analysis Set (PPS), 4 seropositivity rates, 5 no immunogenicity sample taken, 6 combined Groups 1-3.
Croatian: Protocol Analysis Set - PPS), 4stope seropozitivnosti, 5 nije uzet uzorak za imunogenost, 6kombinirane skupine 1-3.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Croatian: Budući da je ovo odobrenje za stavljanje lijeka u promet u iznimnim okolnostima, sukladno članku 14. stavku 8. Uredbe (EZ) br. 726/2004, nositelj odobrenja dužan je unutar navedenog vremenskog roka provesti sljedeće mjere:
English: For instructions on administration, see section 6.6.
Croatian: Za upute o primjeni, vidjeti dio 6.6.
English: However, it is possible that if you experience any of the side effects listed in section 4, then some of these may affect your ability to drive or use machines (e.g. dizziness).
Croatian: Međutim, ako dobijete bilo koju nuspojavu navedenu u dijelu 4, postoji mogućnost da će neke od njih moći utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima (npr. omaglica).
English: The following information is intended for healthcare professionals only: Instructions for preparation and administration of the vaccine:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima:
English: • If your immune system is weakened you will receive two injections with the second injection no less than 28 days after the first.
Croatian: • Ako Vam je oslabljen imunološki sustav, primit ćete dvije injekcije s time da ćete drugu injekciju primiti najranije 28 dana nakon prve.
English: IMVANEX may not fully protect all people who are vaccinated.
Croatian: IMVANEX možda neće pružiti potpunu zaštitu svim osobama koje se cijepe.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Croatian: Kao i kod svih injekcijskih cjepiva, uvijek treba imati na raspolaganju odgovarajuće medicinsko liječenje i nadzor za slučaj rijetkih anafilaktičkih reakcija nakon primjene ovog cjepiva.
English: The vaccine will be injected under the skin, preferably into the upper arm, by your doctor or a nurse.
Croatian: Ovo će cjepivo ubrizgati pod kožu, po mogućnosti na nadlaktici, Vaš liječnik ili medicinska sestra.
English: • swelling of the ankles, feet or fingers,
Croatian: • oticanje gležnjeva, stopala ili prstiju na rukama,
English: • increase of cardiac laboratory values (like Troponin I ), liver enzyme increased, white blood cell count decreased, mean platelet volume decreased
Croatian: • povišene srčane laboratorijske vrijednosti (poput troponina I), povišene vrijednosti jetrenih enzima, snižen broj bijelih krvnih stanica, smanjen prosječni volumen krvnih pločica,
English: In case of any particles and/or abnormal appearance, the vaccine should be discarded.
Croatian: U slučaju prisutnosti čestica i/ili neuobičajenog izgleda, cjepivo treba baciti.
English: Some of the undesirable effects mentioned in section 4.8 may affect the ability to drive or use machines (e.g. dizziness).
Croatian: Neke nuspojave navedene u dijelu 4.8 mogu utjecati na sposobnost upravljanja vozilima i rada sa strojevima (npr. omaglica).
English: Lower immune response data have been observed in HIV infected individuals compared to healthy individuals (see section 5.1).
Croatian: Opaženi podaci pokazuju slabiji imunološki odgovor u osoba zaraženih HIV-om u usporedbi sa zdravim osobama (vidjeti dio 5.1).
English: This vaccine contains trace residues of gentamicin (see section 4.3).
Croatian: Ovo cjepivo sadrži ostatke gentamicina u tragovima (vidjeti dio 4.3).
English: Immunisation should be carried out by subcutaneous injection, preferably into the upper arm (deltoid).
Croatian: Imunizaciju treba provesti supkutanom injekcijom, po mogućnosti u nadlakticu (deltoid).
English: • night sweats,
Croatian: • noćno znojenje,
English: To ensure adequate monitoring of safety and/or effectiveness, the applicant should perform the following studies to collect data where IMVANEX is used as a prophylactic vaccine and/or use in case of re-emergence of circulating smallpox.
Croatian: Da bi se osigurao odgovarajući nadzor sigurnosti i/ili učinkovitosti, podnositelj zahtjeva treba provesti sljedeća ispitivanja za prikupljanje podataka kada se IMVANEX primjenjuje kao profilaktičko cjepivo i/ili primjenjuje u slučaju ponovne pojave cirkulirajućih velikih boginja.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or trace residues (chicken protein, benzonase and gentamicin).
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili tvari preostale u tragovima (pileći protein, benzonaza i gentamicin).
English: There is no information on the effect of IMVANEX on your ability to drive or use machines.
Croatian: Nema podataka o utjecaju cjepiva IMVANEX na sposobnost upravljanja vozilima ili rada sa strojevima.
English: If you get any of the following side effects, tell your doctor.
Croatian: Ako dobijete neku od sljedećih nuspojava, obavijestite svog liječnika.
English: Trometamol Sodium chloride Water for injections
Croatian: trometamol natrijev klorid voda za injekcije
English: The European Medicines Agency has deferred the obligation to submit the results of studies with IMVANEX in all subsets of the paediatric population for prevention of smallpox infection by active immunisation against smallpox infection and disease (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja cjepiva IMVANEX u svim podskupinama pedijatrijske populacije za sprječavanje infekcije velikim boginjama aktivnom imunizacijom protiv infekcije i bolesti velikih boginja (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: *represents seropositivity rates
Croatian: *predstavlja stope seropozitivnosti.
English: This vaccine contains trace residues of gentamicin and benzonase.
Croatian: Ovo cjepivo sadrži ostatke gentamicina i benzonaze u tragovima.
English: Hejreskovvej 10 A, Kvistgård, 3490, Denmark
Croatian: Hejreskovvej 10 A, Kvistgård, 3490, Danska
English: • swelling of the face, mouth and throat,
Croatian: • oticanje lica, usta i grla,
English: The most common adverse reactions observed in clinical trials were injection site reactions and common systemic reactions typical for vaccines which were mild to moderate in intensity and resolved without intervention within seven days following vaccination.
Croatian: Najčešće nuspojave opažene u kliničkim ispitivanjima bile su reakcije na mjestu injiciranja i uobičajene sistemske reakcije tipične za cjepiva koje su bile blagog do umjerenog intenziteta i povukle su se bez intervencije u roku od sedam dana nakon cijepljenja.
English: A second dose of 0.5 ml should be administered no less than 28 days after the first dose.
Croatian: Drugu dozu od 0,5 ml treba primijeniti ne ranije od 28 dana nakon prve doze.
English: In the event of any damage to the vial, foreign particulate matter and/or variation of physical aspect being observed, discard the vaccine.
Croatian: U slučaju da se primijeti oštećenje bočice, prisutnost stranih čestica i/ili promjena fizičkih svojstava, cjepivo bacite.
English: • nerve disorder causing weakness, tingling or numbness,
Croatian: • poremećaj živca koji uzrokuje slabost, trnce ili utrnulost,
English: 1 Produced in chick embryo cells
Croatian: 1Proizveden u stanicama pilećeg embrija
English: What IMVANEX looks like and contents of the pack
Croatian: Kako IMVANEX izgleda i sadržaj pakiranja
English: The second co-primary endpoint evaluated if vaccination with Imvanex (n = 165) prior to administration of ACAM2000 results in an attenuation of the cutaneous reaction to ACAM2000 (n = 161) as measured by maximum lesion area in mm2.
Croatian: Druga primarna mjera ishoda ocijenila je da li cijepljenje cjepivom IMVANEX (n = 165) prije primjene ACAM2000 rezultira atenuacijom kožne reakcije na ACAM2000 (n = 161) mjerenjem maksimalne površine lezije u mm2.
English: In a non-placebo controlled clinical trial that compared the safety of IMVANEX in individuals with AD to healthy individuals, individuals with AD reported erythema (61.2%) and swelling (52.2%) at the injection site with a higher frequency than healthy individuals (49.3% and 40.8%, respectively).
Croatian: U kliničkim ispitivanjima bez kontrole placebom u kojima se uspoređivala sigurnost cjepiva IMVANEX u osoba s AD-om i zdravih osoba, osobe s AD-om prijavile su eritem (61,2%) i oticanje (52,2%) na mjestu injiciranja s većom učestalošću nego zdrave osobe (49,3% odnosno 40,8%).
English: The following general symptoms were reported more frequently in individuals with AD compared to healthy individuals: headache (33.1% vs. 24.8%), myalgia (31.8% vs. 22.3%), chills (10.7% vs. 3.8 %), nausea (11.9% vs. 6.8%), and fatigue (21.4% vs. 14.4%).
Croatian: Sljedeći opći simptomi bili su češće zabilježeni u osoba s AD-om u usporedbi sa zdravim osobama: glavobolja (33,1% naspram 24,8%), mialgija (31,8% naspram 22,3%), zimica (10,7% naspram 3,8%), mučnina (11,9% naspram 6,8%) i umor (21,4% naspram 14,4%).
English: This means that because of the lack of smallpox disease in the world it has not been possible to obtain complete information on this medicinal product.
Croatian: To znači da zbog toga što u svijetu nema velikih boginja nije bilo moguće doći do potpunih informacija o ovom lijeku.
English: Two clinical studies have demonstrated that IMVANEX is able to boost a pre-existing immunological memory response, induced by either licensed smallpox vaccines a long time ago or two years after IMVANEX.
Croatian: Dva su klinička ispitivanja pokazala da IMVANEX može pojačati odgovor već postojećeg imunološkog pamćenja, izazvanog odobrenim cjepivima protiv velikih boginja prije puno vremena ili dvije godine nakon cjepiva IMVANEX.
English: Once the frozen vaccine has been thawed, IMVANEX is a pale milky coloured homogeneous suspension for injection.
Croatian: Nakon što se zamrznuto cjepivo jednom odmrzne, IMVANEX je homogena suspenzija za injekciju blijede, mliječne boje.
English: Therefore, concomitant administration of IMVANEX with other vaccines should be avoided.
Croatian: Stoga treba izbjegavati istovremenu primjenu cjepiva IMVANEX s drugim cjepivima.
English: At day 13-15, the median maximum lesion area for subjects who were administered ACAM2000 was 75mm2 (95% CI 69.0, 85.0) and for those who received Imvanex it was 0.0 (95% CI 0.0, 2.0).
Croatian: Tijekom 13-15 dana srednja maksimalna površina lezije kod ispitanika koji su primili ACAM2000 iznosila je 75 mm2 (95% CI 69,0; 85,0), a za skupinu koja je primila IMVANEX to je iznosilo 0,0 (95% CI 0,0; 2,0).
English: Immunocompromised patients (e.g. HIV infected, patients under immunosuppressive therapy) who have been previously vaccinated against smallpox should receive two booster doses.
Croatian: Imunokompromitirani bolesnici (npr. zaraženi HIV-om, bolesnici na imunosupresivnoj terapiji) koji su prethodno bili cijepljeni protiv velikih boginja trebaju primiti dvije doze za docijepljivanje (booster doze).
English: If you forget to receive IMVANEX
Croatian: Ako ste zaboravili primiti IMVANEX
English: Do not re-freeze a vial once it has been thawed.
Croatian: Nemojte ponovno zamrzavati nakon što se cjepivo jednom odmrzne.
English: Primary vaccination (individuals previously not vaccinated against smallpox): A first dose of 0.5 ml should be administered on an elected date.
Croatian: Primarno cijepljenje (osobe koje prethodno nisu bile cijepljene protiv velikih boginja): Prvu dozu od 0,5 ml treba primijeniti na odabrani dan.
English: IMVANEX should not be administered by intravascular injection.
Croatian: IMVANEX se ne smije primijeniti intravaskularnom injekcijom.
English: Imvanex was compared to ACAM2000 (a 'second generation' live attenuated smallpox vaccine produced in cell culture and licenced in the United States of America) in a randomized, open-label non-inferiority clinical trial in healthy adults (US military personnel) aged 18 to 42 years and who were naïve to smallpox vaccine (Study POX-MVA-006).
Croatian: IMVANEX je bio uspoređen / ispitan u odnosu na ACAM2000 (druga generacija cjepiva sa živim atenuiranim virusom velikih boginja proizvedenim u staničnoj kulturi i licenciranim u Sjedinjenim Američkim Državama) u randomiziranom, otvorenom, kliničkom ispitivanju neinferiornosti u zdravih ispitanika (vojno osoblje SAD-a) u dobi između 18 i 42 godine koji prethodno nisu primili cjepivo protiv velikih boginja (Ispitivanje POX-MVA-006).
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