FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Clopidogrel/Acetylsalicylic acid Mylan have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Clopidogrel/Acetylsalicylic acid Mylan nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Clopidogrel/Acetylsalicylic acid Mylan contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin) and is a ‘generic medicine'.
Croatian: Clopidogrel/Acetylsalicylic acid Mylan sadrži dvije djelatne tvari, klopidogrel i acetilsalicilnu kiselinu (poznatu kao aspirin) te je „generički lijek”.
English: For more information about using Clopidogrel/Acetylsalicylic acid Mylan, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Clopidogrel/Acetylsalicylic acid Mylan pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Therefore, the Agency's view was that, as for DuoPlavin, the benefits of Clopidogrel/Acetylsalicylic acid Mylan outweigh the identified risks and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da, kao i kod lijeka DuoPlavin, koristi od lijeka Clopidogrel/Acetylsalicylic acid Mylan nadmašuju identificirane rizike te da lijek može biti odobren za primjenu u EU-u.
English: An overview of Clopidogrel/Acetylsalicylic acid Mylan and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Clopidogrel/Acetylsalicylic acid Mylan i zašto je odobren u EU-u
English: What measures are being taken to ensure the safe and effective use of Clopidogrel/Acetylsalicylic acid Mylan?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Clopidogrel/Acetylsalicylic acid Mylan?
English: Clopidogrel/Acetylsalicylic acid Mylan (clopidogrel / acetylsalicylic acid)
Croatian: Clopidogrel/Acetylsalicylic acid Mylan (klopidogrel / acetilsalicilna kiselina)
English: As for every medicine, the company provided studies on the quality of Clopidogrel/Acetylsalicylic acid Mylan.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja kakvoće lijeka Clopidogrel/Acetylsalicylic acid Mylan.
English: As for all medicines, data on the use of Clopidogrel/Acetylsalicylic acid Mylan are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Clopidogrel/Acetylsalicylic acid Mylan kontinuirano se prate.
English: Why is Clopidogrel/Acetylsalicylic acid Mylan authorised in the EU?
Croatian: Zašto je lijek Clopidogrel/Acetylsalicylic acid Mylan odobren u EU-u?
English: Other information about Clopidogrel/Acetylsalicylic acid Mylan
Croatian: Ostale informacije o lijeku Clopidogrel/Acetylsalicylic acid Mylan
English: What are the benefits and risks of Clopidogrel/Acetylsalicylic acid Mylan?
Croatian: Koje su koristi i rizici od lijeka Clopidogrel/Acetylsalicylic acid Mylan?
English: What is Clopidogrel/Acetylsalicylic acid Mylan and what is it used for?
Croatian: Što je Clopidogrel/Acetylsalicylic acid Mylan i za što se koristi?
English: How does Clopidogrel/Acetylsalicylic acid Mylan work?
Croatian: Kako djeluje Clopidogrel/Acetylsalicylic acid Mylan?
English: How has Clopidogrel/Acetylsalicylic acid Mylan been studied?
Croatian: Kako je Clopidogrel/Acetylsalicylic acid Mylan ispitivan?
English: How is Clopidogrel/Acetylsalicylic acid Mylan used?
Croatian: Kako se Clopidogrel/acetilsalicilna kiselina Mylan primjenjuje?
English: Package size
Croatian: Package size name
English: EU Number
Croatian: Number
English: Strength Pharmaceutical Form
Croatian: Invented Strength Pharmaceutical Route of
English: Multi-dose vial (glass)
Croatian: Višedozni bočica (staklo)
English: Packaging Content (concentration)
Croatian: Packaging Content
English: 1 syringe
Croatian: intramuskularna
English: Single-dose prefilled syringe (glass) without needle
Croatian: 20 bočice mikrograma / ubrizgavanje koristiti intramuskularnaus e bočica (staklo) (staklo)
English: 20 vials
Croatian: (staklo)
English: EMA/391542/2013 EMEA/H/C/002201
Croatian: 28. lipnja 2013. EMA/403463/2013 EMEA/H/C/002201
English: What consequences does this refusal have for patients in clinical trials or compassionate use programmes?
Croatian: Kakve posljedice ovo odbacivanje zahtjeva ima za bolesnike, koji sudjeluju u kliničkim istraživanjima ili programima milosrdne primjene lijeka?
English: FEV1 is the maximum volume of air a person can breathe out in one second, while PEF is the maximum speed at which a person can expel air from their lungs.
Croatian: FEV1 predstavlja maksimalan volumen zraka kojeg osoba može izdahnuti u jednoj sekundi, dok PEF predstavlja maksimalnu brzinu pri kojoj osoba izbacuje zrak iz pluća.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 27 June 2013.
Croatian: Nakon razmatranja osnovanosti ovog zahtjeva, CHMP ponovno je ispitao prvotno mišljenje i potvrdio je odbijanje zahtjeva za odobrenje za stavljanje lijeka u promet dana 27. lipnja 2013.
English: The CHMP refusal was confirmed after re-examination.
Croatian: Odbacivanje zahtjeva CHMP potvrđeno je nakon ponovljenog ispitivanja.
English: The two active substances in Labazenit are well known and are present in several medicines used to treat asthma, either alone or in combination with other medicines.
Croatian: Dvije djelatne tvari u lijeku Labazenit dobro su poznate i prisutne su u nekoliko lijekova, koji se koriste za liječenje astme, bilo samostalno ili u kombinaciji s drugim lijekovima.
English: On 21 March 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Labazenit, intended for the treatment of asthma.
Croatian: Dana 21. ožujka 2013., Povjerenstvo za humane lijekove (CHMP) usvojilo je negativno mišljenje kojim se preporuča odbijanje zahtjeva za odobrenje za stavljanje u promet lijeka Labazenit predviđenog za liječenje astme.
English: It was to be available as capsules containing powder for inhalation.
Croatian: Trebao je biti dostupan u obliku kapsula, koje sadrže prašak za inhalaciju.
English: The primary measures of effectiveness were based on the patients' forced expiratory volumes (FEV1) or peak expiratory flow (PEF) after treatment.
Croatian: Primarne mjere djelotvornosti temeljene su na forsiranom ekspiratornom volumenu u prvoj sekundi (FEV1) ili vršnom ekspiratornom protoku zraka (PEF) nakon liječenja.
English: The company that applied for authorisation is Laboratoires SMB s.a.
Croatian: Zahtjev za davanje odobrenja za stavljanje lijeka u promet podnijelo je društvo Laboratoires SMB s.a.
English: Salmeterol is a long-acting beta-2 agonist and it works by attaching to receptors known as beta-2 receptors found in the muscles of the airways.
Croatian: Salmeterol je dugodjelujući beta-2 agonist, koji djeluje vezujući se na receptore poznate pod nazivom beta-2 receptori, a koji se nalaze u mišićima zračnih putova.
English: What is Labazenit?
Croatian: Što je lijek Labazenit?
English: The CHMP therefore concluded that the benefits of the medicine had not been shown to outweigh its risks and recommended that it be refused marketing authorisation.
Croatian: Stoga je CHMP zaključio da prednosti lijeka nisu dokazano nadmašile rizike, te preporuča da se odbaci zahtjev za davanje odobrenja.
English: The company presented results of two main studies that compared Labazenit with salmeterol alone in a total of 83 asthma patients, and one main study comparing Labazenit with budesonide alone in 375 patients.
Croatian: Društvo je dostavilo rezultate dva glavna ispitivanja, u kojima se lijek Labazenit samo sa salmeterolom uspoređuje u ukupno 83 bolesnika oboljelih od astme, i jedno glavno ispitivanje, u kojem se lijek Labazenit samo s budesonidom uspoređuje u 375 bolesnika.
English: In addition, data from another study indicated that lower amounts of budesonide may reach the lungs when Labazenit is used.
Croatian: Nadalje, podaci iz drugih ispitivanja ukazali su da manje količine budesonida mogu dospjeti u pluća prilikom primjene lijeka Labazenit.
English: Budesonide is a corticosteroid that works as an anti-inflammatory agent.
Croatian: Budesonid je kortikosteroid, koji djeluje kao protuupalno sredstvo.
English: What did the company present to support its application?
Croatian: Koju je dokumentaciju društvo priložilo uz svoj zahtjev?
English: When inhaled, it reduces inflammation in the airways, thereby helping to keep the patients' airways clear and allowing them to breathe more easily.
Croatian: Prilikom inhalacije, ovaj lijek smanjuje upalu u zračnim putovima, te stoga pomaže pri održavanju prohodnosti zračnih putova bolesnika i omogućuje lakše disanje bolesnicima.
English: When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Croatian: Prilikom vezanja na ove receptore, ova djelatna tvar uzrokuje opuštanje mišića, čime se zračni putovi održavaju otvorenima i pomaže u disanju bolesnika.
English: The company informed the CHMP that there were no ongoing clinical trials with Labazenit in Europe at the time of the CHMP's opinion.
Croatian: Društvo je obavijestilo CHMP da se u trenutku donošenja mišljenja CHMP u Europi ne provode klinička ispitivanja s lijekom Labazenit.
English: Two larger supportive studies involving 601 patients were also conducted, comparing Labazenit with other corticosteroid-beta-2 agonist combination treatments.
Croatian: Također su provedena dva veća pomoćna ispitivanja, koja su obuhvatila 601 bolesnika, u kojima je Labazenit uspoređen s drugim kombiniranim liječenjima kortikosteroid-beta-2 agonistom.
English: The CHMP's main concern was that the study comparing Labazenit with budesonide alone did not prove that the anti-inflammatory effect of Labazenit was sufficient.
Croatian: Glavno razmatranje CHMP jest da ispitivanje kojim se uspoređuje Labazenit samo s budesonid nije dokazalo dostatno protuupalno djelovanje lijeka Labazenit.
English: Labazenit was expected to be used in the treatment of asthma in adults for whom a combination product containing an inhaled corticosteroid and long-acting beta-2 agonist is required.
Croatian: Labazenit se trebao upotrebljavati u liječenju astme u odraslih, za koje je potrebna kombinirani lijek, koji sadrži inhalirani kortikosteroid i dugodjelujući beta-2 agonist.
English: Labazenit is a medicine that contains the active substances budesonide and salmeterol.
Croatian: Labazenit je lijek, koji sadrži djelatne tvari budesonid i salmeterol.
English: The effects of Labazenit were first tested in experimental models before being studied in humans.
Croatian: Prije ispitivanja na ljudima djelovanje lijeka Labazenit prvi put je testirano na eksperimentalnim uzorcima.
English: What was Labazenit expected to be used for?
Croatian: Za što bi se lijek Labazenit upotrebljavao?
English: How is Labazenit expected to work?
Croatian: Kako bi lijek Labazenit djelovao?
English: Several adverse events were solicited in the clinical studies and are designated with the symbol (
Croatian: Nekoliko je nuspojava utvrđeno u kliničkim ispitivanjima i označeno simbolom (
English: North Carolina 27712 U.S.A.
Croatian: North Carolina 27712 SAD
English: Symptoms may persist for a matter of months or on rare occasions for years.
Croatian: Simptomi mogu trajati i mjesecima, a u rijetkim slučajevima i godinama.
English: • An allergic reaction to eggs or anything that contained egg.
Croatian: • Alergijsku reakciju na jaja ili bilo što što sadrži jaja.
English: Even in older women (35 to 45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
Croatian: Čak i u starijih žena (u dobi od 35 do 45 godina) te se reakcije općenito dobro podnose i rijetko ometaju uobičajene aktivnosti.
English: The appropriate time and number of injections will be determined by your doctor in accordance with official recommendations.
Croatian: Odgovarajuće vrijeme i broj injekcija odredit će Vaš liječnik sukladno službenim preporukama.
English: d. Other special populations
Croatian: Druge posebne populacije
English: ProQuad should be used in accordance to official recommendations.
Croatian: ProQuad treba primjenjivati u skladu sa službenim preporukama.
English: • Individuals less than 9 months of age
Croatian: • Osobe mlađe od 9 mjeseci
English: The safety and efficacy of ProQuad in children under 9 months of age have not been established.
Croatian: Sigurnost i djelotvornost cjepiva ProQuad u djece mlađe od 9 mjeseci nisu ustanovljene.
English: • immunocompromised individuals (see section 4.3),
Croatian: • imunokompromitirane osobe (vidjeti dio 4.3),
English: The antibodies help protect against diseases caused by these viruses.
Croatian: Protutijela pomažu u zaštiti protiv bolesti koje uzrokuju ti virusi.
English: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Not known (cannot be estimated from the available data)
Croatian: Vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); nepoznato (ne može se procijeniti iz dostupnih podataka)
English: Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed.
Croatian: Treba utvrditi serološki status kako bi se odredilo da li su potrebne dodatne doze cjepiva.
English: Active untreated tuberculosis.
Croatian: Neliječena aktivna tuberkuloza.
English: Vaccination should be postponed during any illness with fever >38.5C.
Croatian: Cijepljenje se mora odgoditi za vrijeme trajanja bilo koje bolesti s vrućicom >38,5C.
English: The vaccine may contain traces of recombinant human albumin (rHA).
Croatian: Cjepivo može sadržavati rekombinantni humani albumin (rHA) u tragovima.
English: What ProQuad is and what it is used for
Croatian: Što je ProQuad i za što se koristi
English: The vaccine may be administered to persons from 12 months of age.
Croatian: Cjepivo se može primijeniti u osoba u dobi od 12 mjeseci.
English: Your doctor will decide when to give the missed dose.
Croatian: Liječnik će odlučiti kada primijeniti propuštenu dozu.
English: No case of overdose has been reported.
Croatian: Nije bio prijavljen niti jedan slučaj predoziranja.
English: Women who intend to become pregnant should be advised to delay.
Croatian: Ženama koje namjeravaju zatrudnjeti treba savjetovati da odgode trudnoću.
English: There are no long-term data currently available with ProQuad (see section 5.1).
Croatian: Trenutno nema dostupnih dugotrajnih podataka za ProQuad (vidjeti dio 5.1).
English: However, vaccination may be less effective than for uninfected persons (see Do not use ProQuad).
Croatian: Međutim, cijepljenje može biti manje djelotvorno nego u nezaraženih osoba (pogledajte Nemojte primjenjivati ProQuad).
English: Tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines (or other vaccines).
Croatian: Obavijestite svog liječnika ili ljekarnika ako Vi ili Vaše dijete uzimate ili ste nedavno uzeli bilo koje druge lijekove (ili druga cjepiva).
English: Widespread use of a 2-dose vaccination schedule in the United States and countries such as Finland and Sweden has led to a >99% reduction in the incidence of each of the 3 targeted diseases.
Croatian: Široko primjenjivan raspored cijepljenja s 2 doze u Sjedinjenim Američkim Državama i zemljama poput Finske i Švedske doveo je do smanjenja incidencije svake od te 3 ciljne bolesti za >99%.
English: What ProQuad looks like and contents of the pack
Croatian: Kako ProQuad izgleda i sadržaj pakiranja
English: After vaccination with ProQuad, IG or VZIG should not be given for 1 month, unless your doctor tells you otherwise.
Croatian: Nakon primjene cjepiva ProQuad, IG ili VZIG ne smiju se dati mjesec dana nakon toga, osim ako Vam liječnik nije rekao drugačije.
English: See also section 3 How to use ProQuad.
Croatian: Pogledajte također dio 3 Kako primjenjivati ProQuad.
English: If you or your child have an allergic reaction, call your doctor right away.
Croatian: Ako Vi ili Vaše dijete imate alergijsku reakciju, odmah se javite liječniku.
English: • An infection with Human Immunodeficiency Virus (HIV) without showing symptoms of HIV disease.
Croatian: • Infekciju virusom humane imunodeficijencije (HIV) ali bez vidljivih simptoma HIV-bolesti.
English: Patients with rare hereditary problems of fructose intolerance should not take this vaccine.
Croatian: Bolesnici s rijetkim nasljednim poremećajima nepodnošenja fruktoze ne smiju primiti ovo cjepivo.
English: Other medicines and ProQuad
Croatian: Drugi lijekovi i ProQuad
English: ProQuad is given by injection as follows:
Croatian: ProQuad se daje injekcijom na sljedeći način:
English: • If the person to be vaccinated is allergic to any of the components of this vaccine (including neomycin or any of the other ingredients listed in section 6).
Croatian: • Ako je osoba koja će se cijepiti alergična na neki od sastojaka ovog cjepiva (uključujući neomicin ili bilo koji drugi sastojak naveden u dijelu 6).
English: Cases of herpes zoster in clinical studies
Croatian: Slučajevi herpes zostera u kliničkim ispitivanjima
English: Social circumstances Activities of daily living impaired
Croatian: Socijalne okolnosti narušene aktivnosti u svakodnevnom životu rijetko
English: Date of first authorisation: 06 April 2006 Date of latest renewal: 16 December 2015
Croatian: Datum posljednje obnove odobrenja: 16. prosinca 2015.
English: • Individuals 12 months of age and older
Croatian: • Osobe u dobi od 12 mjeseci i starije
English: What you need to know before you receive ProQuad
Croatian: Što morate znati prije nego što primite ProQuad
English: Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
Croatian: Odgovarajuće medicinsko liječenje i nadzor trebaju uvijek biti na raspolaganju za slučaj rijetke anafilaktičke reakcije nakon primjene cjepiva.
English: ProQuad is not indicated in this subset of the paediatric population.
Croatian: ProQuad nije indiciran u ovoj podskupini pedijatrijske populacije.
English: Children who received ProQuad intramuscularly
Croatian: Djeca koja su primila ProQuad intramuskularno
English: Therefore, administration of any of these products should be avoided within 1 month after a dose of ProQuad unless considered to be essential.
Croatian: Stoga je potrebno izbjegavati primjenu tih proizvoda tijekom 1 mjeseca nakon doze cjepiva ProQuad, osim ako se to ne smatra neophodnim.
English: Reconstitution instructions intended for medical and healthcare professionals are included at the end of the leaflet
Croatian: Upute za pripremu namijenjene zdravstvenim djelatnicima nalaze se na kraju ove upute.
English: It is not known whether ProQuad can cause foetal harm when administered to a pregnant woman or affect reproduction capacity.
Croatian: Nije poznato može li ProQuad prouzročiti oštećenje fetusa kad se primjenjuje u trudnica ili utjecati na reproduktivnu sposobnost.
English: The vaccine should under no circumstances be injected intravascularly.
Croatian: Cjepivo se ni u kojim okolnostima ne smije injicirati intravaskularno.
English: In the absence of compatibility studies, the vaccine must not be mixed with other medicinal products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovo cjepivo se ne smije miješati s drugim lijekovima.
English: Current immunosuppressive therapy (including high doses of corticosteroids) (see section 4.8).
Croatian: Imunosupresivna terapija u tijeku (uključujući visoke doze kortikosteroida) (vidjeti dio 4.8).
English: Concomitant use with other vaccines:
Croatian: Istodobna primjena s drugim cjepivima:
English: Tell the doctor if your child has recently received a vaccine or if one is scheduled to be given in the near future.
Croatian: Obavijestite liječnika ako je Vaše dijete nedavno primilo cjepivo ili ako ga planirate uskoro cijepiti.
English: It is preferred that the second dose be administered within three months following the first dose.
Croatian: Najbolje je da se druga doza primijeni u roku od tri mjeseca nakon prve doze.
English: In the event of either being observed, discard the vaccine.
Croatian: U slučaju da se takvo što opazi, cjepivo odbacite.
English: • If the person to be vaccinated has any illness with fever higher than 38.5°C; however, low grade fever itself is not a reason to delay vaccination.
Croatian: • Ako osoba koja će se cijepiti ima neku bolest s vrućicom višom od 38,5°C; međutim, vrućica niskog stupnja sama po sebi nije razlog za odgađanje cijepljenja.
English: In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (12 to 20%), and the reactions tend to be more marked and of longer duration.
Croatian: U žena su stope incidencije artritisa i artralgije općenito više od onih u djece (12 do 20%), a reakcije su izraženije i dugotrajnije.
English: Persistence of Immune Response
Croatian: Trajnost imunološkog odgovora
English: Furthermore, pregnancy should be avoided for 1 month following vaccination (see section 4.6).
Croatian: Osim toga, trudnoću treba izbjegavati tijekom 1 mjeseca nakon cijepljenja (vidjeti dio 4.6).
English: In the 30-day timeframe following vaccination, no increased risk of febrile seizures was observed (see section 5.1).
Croatian: U razdoblju od 30 dana nakon cijepljenja nije bio primijećen povećan rizik od febrilnih konvulzija (vidjeti dio 5.1).
English: However, the long term effect of varicella vaccination on the incidence of herpes zoster is unknown at present.
Croatian: Međutim, dugotrajni učinak cijepljenja protiv varičele na incidenciju herpes zostera za sada nije poznat.
English: Over the 10-year observation period, the cumulative rate of varicella was 7.5% after 1 dose and 2.2% after 2 doses.
Croatian: Tijekom desetgodišnjeg razdoblja promatranja, kumulativna stopa varičele bila je 7,5% nakon 1 doze i 2,2% nakon 2 doze.
English: As with other vaccines, ProQuad may not completely protect all persons who are vaccinated.
Croatian: Kao druga cjepiva, ProQuad možda neće pružiti potpunu zaštitu svim osobama koje se cijepe.
English: What ProQuad contains
Croatian: Što ProQuad sadrži
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this vaccine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego što primite ovo cjepivo.
English: What ProQuad is and what it is used for What you need to know before you receive ProQuad How to use ProQuad
Croatian: Što je ProQuad i za što se koristi Što morate znati prije nego što primite ProQuad Kako primjenjivati ProQuad Moguće nuspojave
English: Children in these studies were monitored for six weeks post vaccination.
Croatian: U tim su se ispitivanjima djeca pratila šest tjedana nakon cijepljenja.
English: In the infants with serological evidence of rubella infection, none had symptomatic disease.
Croatian: Niti jedno dojenče sa serološki dokazanom rubela infekcijom nije imalo simptomatsku bolest.
English: Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination.
Croatian: Izlučivanje malih količina atenuiranog živog virusa rubele iz nosa ili grla bilo je prisutno u većine osjetljivih osoba 7 do 28 dana nakon cijepljenja.
English: Pharmacotherapeutic group: Vaccines, Viral Vaccine; ATC code: J07BD54.
Croatian: Farmakoterapijska skupina: cjepiva, virusno cjepivo; ATK oznaka: J07BD54.