FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Infanrix hexa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju cjepivom Infanrix hexa pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Why is Infanrix hexa approved?
Croatian: Zašto je cjepivo Infanrix hexa odobreno?
English: Infanrix hexa is given by deep injection into a muscle.
Croatian: Cjepivo Infanrix hexa daje se dubokom injekcijom u mišić.
English: For practical information about using Infanrix hexa, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Za praktične informacije o primjeni cjepiva Infanrix hexa bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: Infanrix hexa must not be used in infants who are hypersensitive (allergic) to any of the active substances, to any of the other ingredients of the vaccine, or to neomycin and polymyxin (antibiotics) and formaldehyde.
Croatian: Infanrix hexa ne smije se primjenjivati u dojenčadi preosjetljivoj (alergičnoj) na bilo koju od djelatnih tvari ili ostalih sastojaka cjepiva, ili na neomicin i polimiksin (antibiotici) i formaldehid.
English: What is the risk associated with Infanrix hexa?
Croatian: Koji su rizici povezani s cjepivom Infanrix hexa?
English: What is Infanrix hexa and what is it used for?
Croatian: Što je Infanrix hexa i za što se koristi?
English: The safety of Infanrix hexa is similar to other vaccines used to prevent these conditions.
Croatian: Sigurnost cjepiva Infanrix hexa slična je sigurnosti drugih cjepiva korištenih za zaštitu od ovih bolesti.
English: Infanrix hexa diphtheria (D), tetanus (T), pertussis (acellular, component) (PA), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed)
Croatian: Konjugirano cjepivo (adsorbirano) protiv difterije (D), tetanusa (T), pertusisa (nestanično, komponentno) (PA), hepatitisa B (rDNA) (HBV), poliomijelitisa (inaktivirano) (IPV) i bakterije Haemophilus influenzae tipa b (Hib)
English: Results of the studies taken together showed that a course of injections with Infanrix hexa was as effective at producing protective levels of antibodies as giving separate vaccines containing the same active substances.
Croatian: Rezultati ispitivanja pokazali su da je cjepivo Infanrix hexa jednako učinkovito u proizvodnji zaštitnih slojeva antitijela kao i zasebna cjepiva koja sadržavaju iste djelatne tvari.
English: These studies showed that booster vaccinations with Infanrix hexa were as effective as giving separate vaccines containing the same active substances 1 month after the booster vaccination.
Croatian: Ta ispitivanja pokazala su da je docjepljivanje cjepivom Infanrix hexa jednako učinkovito kao cijepljenje zasebnim cjepivima koja sadržavaju iste djelatne tvari mjesec dana nakon docjepljivanja.
English: Infanrix hexa should be postponed in infants with a severe sudden fever.
Croatian: Primjena cjepiva Infanrix hexa mora se odgoditi u dojenčadi koja je imala iznenadnu visoku tjelesnu temperaturu.
English: The effects of Infanrix hexa were compared with those of separate vaccines containing the same active substances.
Croatian: Djelovanje cjepiva Infanrix hexa uspoređeno je s djelovanjem zasebnih cjepiva koja sadržavaju iste djelatne tvari.
English: What benefits of Infanrix hexa have been shown in studies?
Croatian: Koje su koristi cjepiva Infanrix hexa dokazane u ispitivanjima?
English: Infanrix hexa is a vaccine used to protect babies and toddlers against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and diseases such as bacterial meningitis caused by the bacterium Haemophilus influenzae type b (Hib).
Croatian: Infanrix hexa je cjepivo koje se koristi za zaštitu dojenčadi i male djece od difterije, tetanusa, pertusisa (kašlja hripavca), hepatitisa B, polimijelitisa (polio) i bolesti kao što su bakterijski meningitis uzrokovan bakterijom Haemophilus influenzae tipa b (Hib).
English: Overall, between 95 and 100% of the children had antibodies to diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses, and Hib, 1 month after the vaccination course.
Croatian: Sveukupno je između 95 % i 100 % djece razvilo antitijela protiv difterije, tetanusa, pertusisa, virusa hepatitisa B, virusa poliomijelitisa i bakterije Haemophilus influenzae tipa B mjesec dana nakon cijepljenja.
English: It must not be used in infants who have had an allergic reaction to a vaccine containing diphtheria, tetanus, pertussis, hepatitis B, polio or Hib.
Croatian: Ne smije se primjenjivati u dojenčadi koja je imala alergijsku reakciju na cjepivo koje sadržava sastavnice difterije, tetanusa, pertusisa, hepatitisa B, poliomijelitisa ili Haemophilus influenzae tipa
English: How is Infanrix hexa used?
Croatian: Kako se Infanrix hexa koristi?
English: For the full list of side effects reported with Infanrix hexa, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni cjepiva Infanrix hexa potražite u uputi o lijeku.
English: The immune system will then be able to produce antibodies more quickly when the person comes into contact with the bacteria or viruses.
Croatian: Kad osoba bude izložena bakterijama ili virusima, imunosni sustav moći će brže proizvesti antitijela.
English: Infanrix hexa has been shown to be effective at producing protective levels of antibodies against diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses, and Hib.
Croatian: Cjepivo Infanrix hexa pokazalo se učinkovitim u proizvodnji zaštitnih razina antitijela protiv difterije, tetanusa, pertusisa, virusa hepatitisa B, virusa poliomjelitisa i Haemophilus influenzae tipa B.
English: How does Infanrix hexa work?
Croatian: Kako djeluje Infanrix hexa?
English: It is used in certain groups of people:
Croatian: Koristi se u određenim skupinama ljudi:
English: Your doctor might change the dose.
Croatian: Liječnik Vam može promijeniti dozu.
English: When to treat yourself
Croatian: Kada se liječiti sam
English: However, there is no medical reason to think that it would affect your ability.
Croatian: Međutim, nema medicinskog razloga zbog kojeg bi se mislilo da ima utjecaj na Vaše sposobnosti.
English: Always wash your hands and ensure that the area around you is clean.
Croatian: Uvijek operite ruke i pobrinite se da je površina oko Vas čista.
English: Positive status indicates at least one positive test at any admission.
Croatian: Pozitivan status ukazuje na najmanje jedan pozitivan test prilikom bilo koje primjene.
English: 1 KIU equals 1,000 IU (International Units).
Croatian: 1 KIU odgovara 1000 IU (internacionalnih jedinica).
English: • Take out the number of NovoSeven packages you need.
Croatian: • Uzmite onoliki broj NovoSeven pakiranja koliko trebate.
English: This reduces the need for hospitalisation and days absent from work and school.
Croatian: Time se smanjuje potreba za bolničkim liječenjem i izostanak s posla i škole.
English: Monitoring of treatment - laboratory tests
Croatian: Praćenje liječenja - laboratorijski testovi
English: To achieve the best results, follow the prescribed dose carefully.
Croatian: Za postizanje najboljih rezultata, pažljivo se pridržavajte propisane doze.
English: Two dosing regimens can be recommended:
Croatian: Mogu se preporučiti dva načina doziranja:
English: Read all of this leaflet carefully before you are given this injection because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego dobijete ovu injekciju jer sadrži Vama važne podatke.
English: It must be colourless.
Croatian: Mora biti bezbojna.
English: Distribution, elimination and linearity
Croatian: Distribucija, eliminacija i linearnost
English: What NovoSeven is and what it is used for
Croatian: Što je NovoSeven i za što se koristi
English: The duration of home therapy should not exceed 24 hours.
Croatian: Kućno liječenje ne smije trajati dulje od 24 sata.
English: Explain that you have been using NovoSeven.
Croatian: Objasnite da ste koristili NovoSeven.
English: The dose schedule should not be intentionally increased above the recommended doses due to the absence of information on the additional risk that may be incurred.
Croatian: Doziranje ne treba namjerno povećavati iznad preporučene doze zbog nedostatka informacija o dodatnom riziku koji se može javiti.
English: Date of first authorisation: 23 February 1996 Date of latest renewal: 23 February 2006
Croatian: Datum prvog odobrenja: 23. veljače 1996.
English: - Angina pectoris
Croatian: - Angina pektoris
English: You will usually need hospital care.
Croatian: Vam trebati bolničko liječenje.
English: NovoSeven is a blood coagulation factor.
Croatian: NovoSeven je krvni koagulacijski faktor.
English: • Inject slowly over 2 to 5 minutes.
Croatian: • Injicirajte polako tijekom 2 do 5 minuta.
English: Only after consultation with the haemophilia treatment centre can continued home treatment be considered.
Croatian: Tek nakon savjetovanja s centrom za liječenje hemofilije može se razmotriti nastavak kućnog liječenja.
English: Before treatment with NovoSeven, make sure your doctor knows:
Croatian: Prije no što započnete liječenje lijekom NovoSeven, pobrinite se da Vaš liječnik zna:
English: At least three doses should be administered to secure effective haemostasis.
Croatian: Potrebno je primijeniti najmanje tri doze da se osigura učinkovita hemostaza.
English: Current clinical experience does not warrant a general differentiation in dosing between children and adults, although children have faster clearance than adults.
Croatian: Trenutno kliničko iskustvo općenito ne opravdava različito doziranje u djece i odraslih, premda djeca imaju brži klirens od odraslih.
English: - Do not freeze.
Croatian: Ne zamrzavati.
English: The pharmacokinetics were similar across sex and ethnic groups.
Croatian: Farmakokinetika je bila slična bez obzira na spol i etničku skupinu.
English: • If you are allergic to mouse, hamster or cow proteins (such as cows' milk).
Croatian: • Ako ste alergični na proteine miša, hrčka ili goveda (primjerice kravlje mlijeko).
English: Other medicines and NovoSeven
Croatian: Drugi lijekovi i NovoSeven
English: • Each time you use NovoSeven, tell your doctor or hospital as soon as possible.
Croatian: • Kad god primijenite NovoSeven, obavijestite liječnika ili bolnicu što je moguće prije.
English: Contents of the pack and other information What NovoSeven contains
Croatian: Sadržaj pakiranja i druge informacije Što NovoSeven sadrži
English: In case of shock, standard medical treatment for shock should be implemented.
Croatian: U slučaju šoka, treba primijeniti uobičajeno liječenje za stanje šoka.
English: What NovoSeven looks like and contents of the pack
Croatian: Kako NovoSeven izgleda i sadržaj pakiranja
English: - Pruritus and urticaria
Croatian: - Pruritus i urtikarija
English: As a precautionary measure, it is preferable to avoid use of NovoSeven during pregnancy.
Croatian: Iz opreza, bolje je izbjegavati primjenu lijeka NovoSeven tijekom trudnoće.
English: • Do not throw it out with the ordinary household waste.
Croatian: • Ne bacajte u obični kućni otpad.
English: OTHER SPECIAL WARNINGS, IF NECESSARY EXPIRY DATE
Croatian: DRUGA POSEBNA UPOZORENJA, AKO JE POTREBNO
English: Safety and efficacy of NovoSeven have not been established outside the approved indications and therefore NovoSeven should not be used.
Croatian: Sigurnost i djelotvornost lijeka NovoSeven nisu utvrđeni izvan odobrenih indikacija i stoga se tada NovoSeven ne bi trebao koristiti.
English: The pharmacokinetic profiles indicated dose proportionality.
Croatian: Farmakokinetički profili ukazali su na proporcionalnost s obzirom na dozu.
English: This results in the conversion of prothrombin into large amounts of thrombin independently of tissue factor.
Croatian: To rezultira pretvorbom protrombina u velike količine trombina neovisno o tkivnom faktoru.
English: Talk to your doctor about when to use the injections and how long to keep using them.
Croatian: Razgovarajte s liječnikom kada primijeniti injekcije i koliko dugo ih trebate primjenjivati.
English: • If you have just had surgery
Croatian: • Ako ste upravo imali operaciju
English: ► If any of these conditions apply to you, talk to your doctor before using the injection.
Croatian: Ako se bilo koje od navedenih stanja odnosi na Vas, obratite se svom liječniku prije nego primijenite injekciju.
English: It works by making the blood clot at the site of bleeding, when the body's own clotting factors are not working.
Croatian: Djeluje tako što stvara krvni ugrušak na mjestu krvarenja kad vlastiti koagulacijski faktori tijela ne djeluju.
English: - Therapeutic response decreased*
Croatian: - Smanjen terapijski odgovor*
English: Pharmacotherapeutic group: Blood coagulation factors, ATC code: B02BD08
Croatian: Farmakoterapijska skupina: krvni koagulacijski faktori, ATK oznaka: B02BD08.
English: • If you are allergic to eptacog alfa (active compound of NovoSeven) or any of the other ingredients in this medicine (listed in section 6).
Croatian: • Ako ste alergični na eptakog alfa (djelatna tvar u lijeku NovoSeven) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Patients should be informed of the early signs of hypersensitivity reactions.
Croatian: Bolesnike treba obavijestiti o ranim znakovima preosjetljivosti.
English: Do not treat yourself for longer than 24 hours without consulting your doctor.
Croatian: Nemojte se sami liječiti dulje od 24 sata bez konzultacije s liječnikom:
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you use NovoSeven.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primijenite NovoSeven.
English: In some cases, the antibodies showed inhibitory effect in vitro.
Croatian: U nekim slučajevima, protutijela su pokazala inhibitorni učinak in vitro.
English: If you have Glanzmann's thrombasthenia:
Croatian: Ako imate Glanzmannovu trombasteniju:
English: If you inject too much NovoSeven, get medical advice at once.
Croatian: Ako injicirate previše lijeka NovoSeven, odmah zatražite medicinski savjet.
English: Remind your doctor if you have a history of allergic reactions as you may need to be monitored more carefully.
Croatian: Podsjetite liječnika ako ste u prošlosti imali alergijske reakcije jer je tada možda potrebno pomnije praćenje.
English: Start treatment of a bleed as early as possible, ideally within 2 hours.
Croatian: Započnite s liječenjem krvarenja što je moguće prije, najbolje unutar 2 sata.
English: There is no clinical experience in people over 65 using this single dose.
Croatian: Nema kliničkog iskustva u ljudi starijih od 65 godina s tom pojedinačnom dozom.
English: In such cases treatment with antihistamines i.v.
Croatian: U takvim slučajevima treba razmotriti i.v. liječenje s antihistaminicima.
English: • If you have Factor VII deficiency
Croatian: • ako imate nedostatak faktora VII
English: Serious bleeding episodes
Croatian: Ozbiljne epizode krvarenja
English: If you inject more NovoSeven than you should
Croatian: Ako injicirate više lijeka NovoSeven nego što ste trebali
English: The dose should be repeated after 2 hours and then at 2 - 3 hour intervals for the first 24 - 48 hours depending on the intervention performed and the clinical status of the patient.
Croatian: Dozu treba ponoviti nakon 2 sata, a potom svaka 2 - 3 sata tijekom prvih 24 - 48 sati ovisno o izvedenom zahvatu i kliničkom stanju bolesnika.
English: Based on a non-clinical study (see section 5.3) it is not recommended to combine rFVIIa and rFXIII.
Croatian: Na temelju nekliničkih ispitivanja (vidjeti dio 5.3) ne preporučuje se kombiniranje rFVIIa i rFXIII.
English: • In cases of a mild or moderate bleed, you should treat yourself as early as possible, ideally at home.
Croatian: • U slučaju blagog ili umjerenog krvarenja, liječenje trebate započeti što je moguće prije, po mogućnosti kod kuće.
English: • Blood clots in arteries in the heart (which could lead to a heart attack or angina), in the brain (which could lead to a stroke) or in the intestine and kidneys.
Croatian: • Krvni ugrušci u arterijama u srcu (što može dovesti do srčanog udara ili angine pektoris), u mozgu (što može dovesti do moždanog udara) ili u crijevima i bubrezima.
English: * Lack of efficacy (therapeutic response decreased) has been reported.
Croatian: * Prijavljen je nedostatak djelotvornosti (smanjen terapijski odgovor).
English: An initial dose of 90 µg per kg body weight is recommended and could be administered on the way to the hospital where the patient is usually treated.
Croatian: Preporučuje se primijeniti početnu dozu od 90 µg po kg tjelesne težine koja se može primijeniti na putu do bolnice gdje se bolesnik uobičajeno liječi.
English: The only complication reported in connection with an overdose was a slight transient increase in blood pressure in a 16 year-old patient receiving 24 mg rFVIIa instead of 5.5 mg.
Croatian: Jedina komplikacija prijavljena u vezi s predoziranjem bila je lagano prolazno povećanje krvnog tlaka u bolesnika starog 16 godina koji je primio 24 mg rFVIIa umjesto 5,5 mg.
English: In the same registry 3 out of 91 surgical patients experienced thromboembolic events.
Croatian: U istom registru kod 3 od 91 kirurškog bolesnika došlo je do tromboembolije.
English: Follow the instructions for proper use for your connector and CVAD in consultation with your doctor or nurse.
Croatian: Slijedite upute o pravilnoj upotrebi Vašeg konektora i CVAD-a u suradnji s Vašim liječnikom ili medicinskom sestrom.
English: • The infusion pump must only be operated by trained hospital personnel.
Croatian: • Infuzijsku pumpu smiju primjenjivati samo educirani bolnički zdravstveni radnici.
English: There is limited experience of using NovoSeven together with medicines called antifibrinolytic drugs (such as aminocaproic acid or tranexamic acid) which are also used to control bleeding.
Croatian: Ograničeno je iskustvo primjene lijeka NovoSeven zajedno s lijekovima koji se zovu antifibrinolitički lijekovi (kao što su aminokaproatna kiselina ili traneksamatna kiselina) koji se također koriste za kontrolu krvarenja.
English: You should talk to your doctor before using NovoSeven with these medicines.
Croatian: Obratite se svom liječniku prije primjene lijeka NovoSeven s ovim lijekovima.
English: If such symptoms occur, the patient should be advised to discontinue use of the product immediately and contact their physician.
Croatian: Ukoliko se ti simptomi pojave, bolesnika treba savjetovati da odmah prekine s primjenom lijeka i kontaktira liječnika.
English: Dose limiting toxicities of NovoSeven have not been investigated in clinical trials.
Croatian: Toksičnosti koje ograničavaju dozu lijeka NovoSeven nisu ispitivane u kliničkim ispitivanjima.
English: Although NovoSeven will be stable for 24 hours after it has been mixed, you should use it at once to avoid infection.
Croatian: Iako će NovoSeven biti stabilan tijekom 24 sata nakon miješanja, trebate ga primijeniti odmah kako ne bi došlo do infekcije.
English: • In case of a severe bleed you should contact your doctor.
Croatian: • U slučaju teškog krvarenja morate se javiti liječniku.
English: The mean terminal half-life ranged from 3.9 to 6.0 hours.
Croatian: Srednji terminalni poluvijek kretao se u rasponu od 3,9 do 6,0 sati.
English: Treatment with NovoSeven, alone or in combination with antifibrinolytics and/or platelets, was defined as effective when bleeding was stopped for at least 6 hours.
Croatian: Liječenje lijekom NovoSeven, samo ili u kombinaciji s antifibrinoliticima i/ili trombocitima definirano je kao učinkovito kada je krvarenje zaustavljeno na najmanje 6 sati.
English: This incompatibility may prevent administration of the drug and/or result in damage to the needleless connector.
Croatian: Ova inkompatibilnost može onemogućiti primjenu lijeka i/ili biti uzrok oštećenja konektora za primjenu bez igle.
English: ► If you notice any of these serious side effects, get medical help immediately.
Croatian: Ako primijetite bilo koju od ovih ozbiljnih nuspojava, odmah zatražite medicinsku pomoć.
English: This complex activates factor IX into factor IXa and factor X into factor Xa, leading to the initial conversion of small amounts of prothrombin into thrombin.
Croatian: Taj kompleks aktivira faktor IX u IXa i faktor X u Xa, što dovodi do početne pretvorbe male količine protrombina u trombin.
English: If the entire dose is not required, use the scale on the syringe to see how much mixed solution is withdrawn.
Croatian: Ako ne trebate cjelokupnu dozu, poslužite se skalom na štrcaljki kako biste vidjeli koliko je izmiješane otopine uvučeno.
English: Therefore, higher doses of rFVIIa may be needed in paediatric patients to achieve similar plasma concentrations as in adult patients (see section
Croatian: Prema tome mogu biti potrebne više doze rFVIIa u pedijatrijskih bolesnika kako bi se postigle slične koncentracije u plazmi kao i u odraslih bolesnika (vidjeti dio 5.2).
English: In most cases of blood clots, the patients were predisposed to blood clotting disorders.
Croatian: U većini slučajeva pojave krvnih ugruška, bolesnici su bili skloni poremećajima zgrušavanja.
English: If you cannot use it at once, see section 5 How to store NovoSeven on the other side of this leaflet.
Croatian: Ako ga ne možete odmah primijeniti, pogledajte dio 5. Kako čuvati NovoSeven na suprotnoj stranici ove Upute o lijeku.
English: • If your arteries are narrowed by disease (atherosclerosis)
Croatian: • Ako su Vam arterije sužene zbog bolesti (ateroskleroza)
English: The mean in vivo plasma recovery was approximately 20%.
Croatian: Srednja vrijednost in vivo povrata plazme bila je otprilike 20%.
English: - Disseminated intravascular coagulation (see section 4.4)
Croatian: - Diseminirana intravaskularna koagulacija (vidjeti dio 4.4)
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke s obzirom na trudnoću, embrionalni/fetalni razvoj, porođaj ili postnatalni razvoj (vidjeti dio
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to mouse, hamster or bovine protein.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili na proteine miša, hrčka ili goveda.
English: • Bring the vial and the pre-filled syringe to room temperature (not above 37°C).
Croatian: • Bočica i napunjena štrcaljka trebaju postići sobnu temperaturu (ne iznad 37°C).
English: There are no clinical data available on interaction between rFVIIa and rFXIII.
Croatian: Nema dostupnih kliničkih podataka o interakciji između rFVIIa i rFXIII.
English: • Lack of effect or decreased response to treatment.
Croatian: • Nedostatak učinka ili smanjen terapijski odgovor.
English: • If bleeding is not controlled within 24 hours, contact your doctor immediately.
Croatian: • Ako se krvarenje ne smanjuje unutar 24 sata, odmah se obratite liječniku.
English: In each of these situations, the potential benefit of treatment with NovoSeven should be weighed against the risk of these complications.
Croatian: U svim navedenim situacijama, moguće povoljne učinke lijeka NovoSeven treba procijeniti s obzirom na rizik pojave ovih komplikacija.
English: Simultaneous use of prothrombin complex concentrates, activated or not, should be avoided.
Croatian: Potrebno je izbjegavati istovremenu primjenu koncentrata protrombinskoga kompleksa, aktiviranog ili ne.
English: Do not use NovoSeven at the same time as prothrombin complex concentrates or rFXIII.
Croatian: Nemojte primjenjivati NovoSeven istodobno s koncentratima protrombinskog kompleksa ili s rFXIII.