FrancophonIA/ELRC3.0 huggingface dataset:
English: • Decrease in the number of white blood cells or some types of white blood cells called neutrophils and a decrease of platelets - shown in blood tests
Croatian: • gljivične infekcije, uključujući vaginalne infekcije i infekcije usne šupljine • smanjenje u broju bijelih krvnih stanica ili određenih vrsta bijelih krvnih stanica naziva neutrofili te smanjenje krvnih pločica - vidljivo iz krvnih pretraga • porast u vrsti bijelih krvnih stanica koje se nazivaju eozinofili - vidljivo iz krvnih pretraga
English: To prepare the Vaborem 2 g/2 g dose for intravenous infusion: Immediately after reconstitution of two vials, the entire reconstituted vial contents should be withdrawn from each of the two vials and added back into the 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) solution for injection (normal saline).
Croatian: Za pripremu doze lijeka Vaborem 2 g/2g za intravensku infuziju: odmah nakon rekonstitucije dviju bočica, potrebno je cijeli rekonstituirani sadržaj bočice izvući iz svake od dvije bočice i dodati natrag u vrećicu za infuziju od 250 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju (obična fiziološka otopina).
English: NAME OF THE MEDICINAL PRODUCT Vaborem 1 g/1 g powder for concentrate for solution for infusion meropenem/vaborbactam
Croatian: Uputa o lijeku: Informacije za bolesnika Vaborem 1 g/1 g prašak za koncentrat za otopinu za infuziju meropenem/vaborbaktam
English: To prepare the Vaborem 1 g/1 g dose for intravenous infusion: Immediately after reconstitution of one vial, the entire reconstituted vial contents should be withdrawn from the vial and added back into the 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) solution for injection (normal saline).
Croatian: Za pripremu doze lijeka Vaborem 1 g/1 g za intravensku infuziju: odmah nakon rekonstitucije jedne bočice, potrebno je cijeli rekonstituirani sadržaj bočice izvući iz bočice i dodati natrag u vrećicu za infuziju od 250 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju (obična fiziološka otopina).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains meropenem trihydrate equivalent to 1 g meropenem and 1 g vaborbactam.
Croatian: Jedna bočica sadrži 1 g meropenema u obliku meropenem trihidrata te 1 g vaborbaktama.
English: • Increase in the level of some types of substances in the blood called urea and creatinine that are signs that your kidneys are working less well - shown in blood tests
Croatian: • porast u razini enzima naziva alkalna fosfataza što može biti znak da vaša jetra, žučni mjehur ili kosti rade manje dobro - vidljivo iz krvnih pretraga
English: Agranulocytosis Haemolytic anaemia
Croatian: Poremećaji krvi i limfnog sustava trombocitemija leukopenija neutropenija eozinofilija trombocitopenija agranulocitoza hemolitička anemija
English: Nervous system disorders
Croatian: Poremećaji probavnog sustava proljev distenzija abdomena
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 6 vials
Croatian: Prašak za koncentrat za otopinu za infuziju
English: Blood and lymphatic system disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja bronhospazam
English: Infusion site thrombosis
Croatian: eritem na mjestu infuzije flebitis na mjestu injiciranja tromboza na mjestu infuzije bol
English: 6.6 Special precautions for disposal and other handling Standard aseptic techniques must be used for solution preparation and administration.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: • At the request of the European Medicines Agency;
Croatian: • na zahtjev Europske agencije za lijekove.
English: If not, your child may not be fully protected against the diseases.
Croatian: U suprotnome, Vaše dijete možda neće biti potpuno zaštićeno od bolesti.
English: Very rare (<1/10,000) Not known (cannot be estimated from available data)
Croatian: Vrlo rijetko (<1/10 000) Nepoznato (ne može se procijeniti iz dostupnih podataka)
English: Important information about the protection provided
Croatian: Važne informacije o zaštiti koju pruža
English: Interference with laboratory testing
Croatian: Interferencija s laboratorijskim testovima
English: Date of latest renewal: 08 January 2018
Croatian: Datum posljednje obnove odobrenja: 8. siječnja 2018.
English: The cough may last for one to two months or longer.
Croatian: Kašalj može trajati jedan do dva mjeseca i duže.
English: No data are available in older children (see sections 4.8 and 5.1).
Croatian: Nema dostupnih podataka za stariju djecu (vidjeti dijelove 4.8 i 5.1)
English: Interference with laboratory testing: see section 4.4.
Croatian: Interferencija s laboratorijskim testovima: vidjeti dio 4.4.
English: Other tests should be performed in order to confirm Hib infection during this period.
Croatian: Treba obaviti druge testove da bi se potvrdila infekcija Hib-om tijekom ovog razdoblja.
English: • difficulty in breathing
Croatian: • poteškoće u disanju
English: What Hexacima is and what it is used for
Croatian: Što je Hexacima i za što se koristi
English: Other medicines or vaccines and Hexacima
Croatian: Drugi lijekovi ili cjepiva i Hexacima
English: However, a lower immune response may be observed and the level of clinical protection is unknown.
Croatian: Međutim, mogao bi se zapaziti niži imunološki odgovor, a stupanj kliničke zaštite nije poznat.
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Croatian: Sukladno članku 114 Direktive 2001/83/EC, službeno puštanje serije lijeka u promet preuzet će državni laboratoriji ili laboratorij određen za tu svrhu.
English: There may be some circumstances, such as high incidence of pertussis, when the potential benefits outweigh possible risks.
Croatian: Postoje neke okolnosti kao što je visoka incidencija hripavca u kojima potencijalna korist nadmašuje mogući rizik.
English: Your doctor will assess the potential benefit offered by vaccination.
Croatian: Vaš liječnik će procijeniti moguće koristi koje nudi cijepljenje.
English: If you forget one dose of Hexacima
Croatian: Ako ste zaboravili jednu dozu cjepiva Hexacima
English: No significant clinical interaction with other treatments or biological products has been reported except in the case of immunosuppressive therapy (see section 4.4).
Croatian: Nije prijavljena značajna klinička interakcija s drugim lijekovima ili biološkim proizvodima, osim u slučaju imunosupresivne terapije (vidjeti dio 4.4).
English: Tell your doctor or nurse if your child is taking, has recently taken or might take any other medicines or vaccines.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako Vaše dijete uzima ili je nedavno uzimalo bilo koje druge lijekove ili bi moglo uzimati bilo koje druge lijekove ili cjepiva.
English: At the end of this period, Hexacima should be used or discarded.
Croatian: Na kraju tog razdoblja Hexacima se mora upotrijebiti ili zbrinuti.
English: Immune responses to the vaccine have not been studied in the context of genetic polymorphism.
Croatian: Imunološki odgovori na cjepivo nisu ispitani u kontekstu genskog polimorfizma.
English: Efficacy and effectiveness in protecting against pertussis
Croatian: Djelotvornost i učinkovitost u zaštiti od hripavca
English: For adsorbent: see section 2.
Croatian: Za adsorbens: vidjeti dio 2.
English: • Temperature of ≥ 40°C within 48 hours not due to another identifiable cause;
Croatian: • Temperatura ≥ 40°C unutar 48 sati ako se ne može ustanoviti drugi uzrok;
English: Effectiveness in protecting against Hib invasive disease
Croatian: Učinkovitost u zaštiti od invazivne Hib bolesti
English: An updated RMP should be submitted:
Croatian: Ažuriran RMP trebadostaviti:
English: Non-clinical data reveal no special hazard for humans based on conventional repeat dose toxicity and local tolerance studies.
Croatian: Neklinički podaci ne upućuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti ponovljenih doza i lokalne podnošljivosti.
English: It can lead to paralysis or muscle weakness most commonly of the legs.
Croatian: To može uzrokovati paralizu ili mišićnu slabost, najčešće nogu.
English: • Diphtheria is an infectious disease that usually first affects the throat.
Croatian: • Difterija je zarazna bolest koja obično najprije zahvaća grlo.
English: Tetanus Toxoid not less than 40 IU2,3
Croatian: Toksoid tetanusa ne manje od 40 IU2,3
English: The vaccine effectiveness was of 96.7% for the full primary series, and 98.5% for booster dose (irrespective of priming).
Croatian: Učinkovitost cjepiva bila je 96,7% kod potpunih primarnih serija, a 98,5% kod docjepljivanja (bez obzira na primarno cijepljenje).
English: At the injection sites, chronic histological inflammatory changes were observed, that are expected to have a slow recovery.
Croatian: Na mjestima injiciranja zapažene su histološke upalne promjene kod kojih se očekuje sporo ozdravljenje.
English: Vaccination is usually justified for individuals whose primary vaccination is incomplete (i.e. fewer than three doses have been received).
Croatian: Cijepljenje je obično opravdano kod pojedinaca u kojih primarna imunizacija nije potpuna (tj. primljene su manje od tri doze).
English: In some people, the virus can stay in the body for a long time, and can eventually lead to serious liver problems, including liver cancer.
Croatian: U nekih ljudi, virus se može zadržati u tijelu duži period i dovesti do ozbiljnih problema s jetrom, uključujući rak jetre.
English: All symptoms should disappear completely within 24 hours without need for treatment.
Croatian: Svi simptomi potpuno nestaju bez liječenja unutar 24 sata.
English: Before the injection of any biological, the person responsible for administration must take all precautions known for the prevention of allergic or any other reactions.
Croatian: Prije injekcije bilo koje biološke djelatne tvari, osoba odgovorna za primjenu mora poduzeti sve poznate mjere opreza za sprječavanje alergijskih i drugih reakcija.
English: This vaccine should be used according to the local vaccination programme.
Croatian: Ovo cjepivo treba se koristiti u skladu s nacionalnim programom cijepljenja.
English: • The vaccine does not contain any live bacteria or viruses and it cannot cause any of the infectious diseases against which it protects.
Croatian: • Ovo cjepivo ne sadrži žive bakterije ili viruse i ne može prouzročiti zarazne bolesti protiv kojih pruža zaštitu.
English: Do not administer by intravascular injection: ensure that the needle does not penetrate a blood vessel.
Croatian: Ne primjenjivati injekcijom intravaskularno: osigurajte da igla ne uđe u krvnu žilu.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV
English: As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Croatian: S obzirom da je u ovoj skupini dojenčadi korist od cijepljenja visoka, cijepljenje ne treba uskratiti ili ga odgađati.
English: • suffers from any undiagnosed illness of the brain or epilepsy which is not controlled.
Croatian: • boluje od bilo koje nedijagnosticirane bolesti mozga ili epilepsije koja nije kontrolirana.
English: Results of long term follow-up demonstrated a dramatic reduction of the pertussis incidence following the second dose regardless of the vaccine used.
Croatian: Rezultati dugoročnog praćenja pokazali su dramatično smanjenje incidencije hripavca nakon primjene druge doze bez obzira na cjepivo koje je korišteno.
English: Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovo cjepivo može uzrokovati nuspojave iako se neće javiti kod svakoga.
English: 12 µg conjugated to Tetanus protein
Croatian: 12 µg konjugiran na protein tetanusa
English: It is recommended to postpone vaccination until the end of such treatment or disease.
Croatian: Preporučuje se odgađanje cijepljenja do kraja takve bolesti ili liječenja.
English: Serious allergic reactions (anaphylactic reaction)
Croatian: Ozbiljne alergijske reakcije (anafilaktička reakcija)
English: Persistence of immune response
Croatian: Trajnost imunološkog odgovora
English: What Hexacima is and what it is used for What you need to know before Hexacima is given to your child How to use Hexacima
Croatian: Što je Hexacima i za što se koristi Što morate znati prije nego što Vaše dijete primi cjepivo Hexacima Kako primjenjivati cjepivo Hexacima
English: To make sure that Hexacima is suitable for your child, it is important to talk to your doctor or nurse if any of the points below apply to your child.
Croatian: Kako biste bili sigurni da je cjepivo Hexacima prikladno za Vaše dijete, važno je da obavijestite svog liječnika ili medicinsku sestru ako se neke od dolje navedenih točaka odnose na Vaše dijete.
English: The risk appears to be dependent on the number of prior doses of acellular pertussis containing vaccine, with a greater risk following the 4th and 5th doses.
Croatian: Čini se da je rizik ovisan o broju prethodno primljenih doza nestaničnog cjepiva protiv hripavca, s većim rizikom nakon 4. i 5. doze.
English: Since the Hib capsular polysaccharide antigen is excreted in the urine, a positive urine test can be observed within 1 to 2 weeks following vaccination.
Croatian: Budući da se polisaharidni antigen kapsule Hib-a izlučuje u mokraći, može se zapaziti pozitivni test urina unutar 1 do 2 tjedna nakon cijepljenja.
English: What Hexacima looks like and contents of the pack
Croatian: Kako Hexacima izgleda i sadržaj pakiranja
English: • Hexacima must be administered intramuscularly.
Croatian: • Hexacima se mora primijeniti intramuskularno.
English: Vaccination with Hexacima may need to be delayed until your child is better.
Croatian: U tom slučaju cijepljenje cjepivom Hexacima može se odgoditi do oporavka Vašeg djeteta.
English: The suspension should be visually inspected prior to administration.
Croatian: Prije primjene suspenziju treba vizualno pregledati.
English: The following convention has been used for the classification of adverse reactions; Very common (≥1/10)
Croatian: Sljedeće pravilo je korišteno za klasifikaciju nuspojava: Vrlo često (≥1/10)
English: Your child could get diseases with similar symptoms if they are caused by other bacteria or viruses.
Croatian: Vaše dijete može oboljeti od bolesti sa sličnim simptomima prouzročenim drugim bakterijama, odnosno virusima.
English: 1541 avenue Marcel Mérieux 69280 Marcy L'Etoile France
Croatian: 1541 avenue Marcel Mérieux 69280 Marcy l'Etoile Francuska
English: Abnormal crying (prolonged crying)
Croatian: Neuobičajeni plač (produženi plač)
English: Nevertheless, vaccination of individuals with chronic immunodeficiency such as HIV infection is recommended even if the antibody response may be limited.
Croatian: Ipak, cijepljenje pojedinaca s kroničnom imunodeficijencijom (kao što je HIV-infekcija) preporučuje se čak i kad odgovor protutijela može biti ograničen.
English: Immunisation must be carried out by intramuscular (IM) injection.
Croatian: Imunizacija se mora provesti intramuskularnom (i.m.) injekcijom.
English: Pertussis vaccine should not be administered to individuals with uncontrolled neurologic disorder or uncontrolled epilepsy until treatment for the condition has been established, the condition has stabilised and the benefit clearly outweighs the risk.
Croatian: Cjepivo protiv hripavca ne smije se primijeniti u pacijenata s nekontroliranim neurološkim poremećajem ili nekontroliranom epilepsijom dok se ne odredi terapija, stabilizira stanje i dok koristi ne budu jasno veće od rizika.
English: This vaccine is not intended for administration to women of child-bearing age.
Croatian: Ovo cjepivo nije namijenjeno za primjenu na ženama u reproduktivnoj dobi.
English: Anti-HBs (≥ 10 mIU/ml)
Croatian: Anti-HB (≥ 10 mIU/ml)
English: • Poliovirus (Inactivated) Types 1/2/3
Croatian: • virus poliomijelitisa (inaktivirani) tip 1/2/3
English: • As with any vaccine, Hexacima may not protect 100% of children who receive the vaccine.
Croatian: • Kao i druga cjepiva, Hexacima možda neće zaštititi 100% djece koja prime cjepivo.
English: If any of these symptoms occur after leaving the place where your child received his/her injection, you must consult a doctor IMMEDIATELY:
Croatian: Ako se bilo koji od navedenih simptoma pojavi nakon što ste napustili mjesto gdje je Vaše dijete primilo injekciju, ODMAH se morate javiti liječniku:
English: Primary 6-10-14 weeks and booster at 15-18 months
Croatian: Primarno cijepljenje u dobi od 6-10-14 tjedana i docjepljivanje u dobi od 15-18 mjeseci
English: For instructions on handling see section 6.6.
Croatian: Za upute za primjenu vidjeti dio 6.6.
English: • Hexacima should not be mixed with other medicinal products.
Croatian: • Hexacima se ne smije miješati s drugim lijekovima.
English: Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000)
Croatian: Manje često (≥1/1 000 do <1/100) Rijetko (≥1/10 000 do <1/1 000)
English: This leaflet was last revised in {MM/YYYY}
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG} Ostali izvori informacija
English: Results obtained for each of the components are summarised in the tables below:
Croatian: U tablicama u nastavku sažeti su podaci za svaku od komponenti:
English: Vaccination should be preceded by a review of the person's medical history (in particular previous vaccinations and possible adverse reactions).
Croatian: Prije cijepljenja potrebno je razmotriti povijest bolesti osobe (posebice prethodna cijepljenja i moguće nuspojave).
English: Hexacima is a whitish, cloudy suspension.
Croatian: Hexacima je bjelkasta, mutna suspenzija.
English: The primary vaccination consists of two doses (with an interval of at least 8 weeks) or three doses (with an interval of at least 4 weeks) in accordance with the official recommendations.
Croatian: Primarno cijepljenje provodi se s dvije doze (u razmaku od najmanje 8 tjedana) ili s tri doze (u razmaku od najmanje četiri tjedna) u skladu sa službenim preporukama.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim dogovorenim ažuriranim verzijama RMP-a.
English: • Poliomyelitis (often just called polio) is caused by viruses that affect the nerves.
Croatian: • Poliomijelitis (često zvan samo polio) uzrokuju virusi koji zahvaćaju živce.
English: • has any problems with the blood that cause easy bruising or bleeding for a long time after minor cuts.
Croatian: • ima bilo kakve probleme s krvlju koji uzrokuju laki nastanak modrica ili dugotrajno krvarenje nakon lakših posjekotina.
English: • Shake the vial so that the contents become homogeneous.
Croatian: • Protresite bočicu tako da sadržaj postane homogen.
English: The safety of Hexacima in children over 24 months of age has not been studied in clinical trials.
Croatian: Sigurnost cjepiva Hexacima u djece starije od 24 mjeseca nije ispitivana u kliničkim ispitivanjima.
English: Associated symptoms may include cyanosis, redness, transient purpura and severe crying.
Croatian: Udruženi simptomi mogu uključivati cijanozu, crvenilo, prolaznu purpuru i jaki plač.
English: • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination;
Croatian: • Kolaps ili stanje slično šoku (hipotonično-hiporesponzivna epizoda) unutar 48 sati od cijepljenja;
English: • Tetanus Toxoid
Croatian: • Toksoid tetanusa
English: • Hepatitis B is caused by the hepatitis B virus.
Croatian: • Hepatitis B uzrokuje virus hepatitisa B.
English: d- Potential adverse events (i.e. adverse events which have been reported with other vaccines containing one or more of the components or constituents of Hexacima and not directly with Hexacima)
Croatian: d- Potencijalne nuspojave (tj. nuspojave koje su prijavljene za druga cjepiva koja sadrže jedan ili više sastavnih dijelova cjepiva Hexacima, a ne izravno za cjepivo Hexacima).
English: Hexacima will be given to your child by a doctor or nurse trained in the use of vaccines and who are equipped to deal with any uncommon severe allergic reaction to the injection (see section 4 Possible side effects).
Croatian: Cjepivo Hexacima će Vašem djetetu dati liječnik ili medicinska sestra koji su osposobljeni i pripremljeni za cijepljenje i postupanje u slučaju pojave bilo kakve neuobičajene ozbiljne alergijske reakcije na cijepljenje (vidjeti dio 4.“Moguće nuspojave“).
English: • Shake the pre-filled syringe so that the contents become homogeneous.
Croatian: • Protresite napunjenu štrcaljku tako da sadržaj postane homogen.
English: When these signs or symptoms (signs or symptoms of anaphylactic reaction) occur they usually develop quickly after the injection is given and while the child is still in the clinic or doctor's surgery.
Croatian: Ti se simptomi (znakovi ili simptomi anafilaktičke reakcije) obično javljaju ubrzo nakon cijepljenja i dok se dijete još uvijek nalazi u bolnici ili u liječničkoj ordinaciji.
English: 3 Or equivalent activity determined by an immunogenicity evaluation 4 Produced on Vero cells
Croatian: 3 Ili ekvivalentna aktivnost utvrđena određivanjem imunogenosti 4 Umnožen na Vero stanicama
English: Hexacima is given as an injection into a muscle (intramuscular route IM) in the upper part of your child's leg or upper arm.
Croatian: Hexacima se daje kao injekcija u mišić (intramuskularnim putem, i.m.) u gornji dio natkoljenice ili nadlaktice Vašeg djeteta.
English: Slightly higher solicited reactogenicity was observed after the first dose compared to subsequent doses.
Croatian: Blago povećana reaktogenost primijećena je nakon primjene prve doze u usporedbi sa sljedećim dozama.
English: Paralysis of the muscles that control breathing and swallowing can be fatal.
Croatian: Ako paraliza zahvati mišiće koji kontroliraju disanje i gutanje, bolest može biti fatalna.
English: • has a moderate or high temperature or an acute illness (e.g. fever, sore throat, cough, cold or flu).
Croatian: • ima umjerenu ili visoku temperaturu ili akutnu bolest (npr. vrućicu, grlobolju, kašalj, prehladu ili gripu).
English: The vaccine works by causing the body to produce its own protection (antibodies) against the bacteria and viruses that cause these different infections:
Croatian: Cjepivo potiče tijelo da stvara vlastitu zaštitu (protutijela) protiv bakterija i virusa koji uzrokuju dolje opisane zarazne bolesti:
English: Hexacima (DTaP-IPV-HB-Hib) is a vaccine used to protect against infectious diseases.
Croatian: Hexacima je cjepivo (DTaP-IPV-HB-Hib) koje se koristi u svrhu zaštite od zaraznih bolesti.
English: However children with long standing problems with their immune system such as HIV infection (AIDS) may still be given Hexacima but the protection may not be as good as in children whose immune system is healthy.
Croatian: Ipak, djeca s dugotrajnim problemima s imunološkim sustavom kao što je HIV-infekcija (AIDS) mogu se cijepiti cjepivom Hexacima iako njih cjepivo neće štiti kao zdravu djecu.
English: A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Hexacima.
Croatian: Febrilne konvulzije u anamnezi, obiteljska anamneza konvulzija ili sindrom iznenadne smrti dojenčeta (SIDS) nisu kontraindikacija za primjenu cjepiva Hexacima.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 April 2013
Croatian: Datum prvog odobrenja: 17. travnja 2013.