FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Raplixa in one or more subsets of the paediatric population in the treatment of haemorrhage resulting from surgical procedure as per Paediatric Investigational Plan (PIP) decision, for the granted indication (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Raplixa u jednoj ili više podskupina pedijatrijske populacije u liječenju krvarenja kao posljedice kirurškog zahvata, po Planu istraživanja u pedijatrijskoj populaciji (PIP-u), za odobrenu indikaciju (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Manufacturers of these products also include steps in the processing of the blood and plasma that can inactivate or remove viruses.
Croatian: Proizvođači tih lijekova također poduzimaju korake u obradi krvi i plazme koji inaktiviraju ili uklanjaju viruse.
English: Raplixa must be used in combination with an approved gelatin sponge (see section 5.1).
Croatian: Raplixa se mora primijeniti u kombinaciji s odobrenom želatinskom spužvicom (vidjeti dio 5.1).
English: This event occurs when an air or gas bubble or bubbles enter a vein or artery and block it.
Croatian: To se događa kada mjehurić(i) zraka ili plina uđu u venu ili arteriju blokirajući je.
English: Raplixa must be used within 2 hours of opening the vial.
Croatian: Raplixa se mora upotrijebiti u roku od 2 sata nakon otvaranja bočice.
English: The amount of Raplixa to be applied and the frequency of application should always be oriented towards the underlying clinical needs for the patient.
Croatian: Količina lijeka Raplixa koja će se primijeniti i učestalost primjene uvijek mora biti usmjerena prema osnovnim kliničkim potrebama bolesnika.
English: The safety and efficacy of Raplixa in children and adolescents under the age of 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Raplixa u djece i adolescenata u dobi do 18 godina nisu ustanovljene.
English: Known hypersensitivity to the Raplixa active substances or to any of the excipients listed in section 6.1.
Croatian: Poznata preosjetljivost na djelatne tvari lijeka Raplixa ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Follow specific instructions for use of the absorbable gelatin sponge.
Croatian: Slijedite posebne upute za uporabu apsorbirajuće želatinske spužvice.
English: Raplixa is supplied in three different presentations 0.5 grams (39.5 mg human fibrinogen and 363 IU human thrombin), 1 gram (79 mg human fibrinogen and 726 IU human thrombin) and 2 grams (158 mg human fibrinogen and 1452 IU human thrombin).
Croatian: Raplixa se isporučuje u tri različita pakiranja: 0,5 grama (39,5 mg ljudskog fibrinogena i 363 IU ljudskog trombina), 1 gram (79 mg ljudskog fibrinogena i 726 IU ljudskog trombina) i 2 grama (158 mg ljudskog fibrinogena i 1452 IU ljudskog trombina).
English: If application of a single layer of Raplixa does not completely stop the bleeding, more may be applied.
Croatian: Ako se primjenom jednog sloja lijeka Raplixa krvarenje potpuno ne zaustavi, može ih se primijeniti i više.
English: Sealant powder Dry white powder.
Croatian: Suhi bijeli prašak.
English: The combination of Raplixa and a gelatin sponge reduced the median time to haemostasis at target sites by up to 2 minutes compared to a gelatin sponge alone.
Croatian: Kombinacija lijeka Raplixa i želatinske spužvice smanjilo je medijan vremena do hemostaze na ciljnim mjestima za do 2 minute u usporedbi sa samom želatinskom spužvicom.
English: Bleeding at target sites was mild or moderate.
Croatian: Krvarenje na ciljnim mjestima bilo je blago do umjereno.
English: 0.5 g, 1 g, 2 g of powder per vial (Type I glass) with a rubber stopper and aluminium/ plastic tear-off.
Croatian: 0,5 g, 1 g, 2 g praška po bočici (staklo tip I) s gumenim čepom i aluminijskim/plastičnim potezačem.
English: The outer aluminium foil sachet may be opened in a non-sterile operating area.
Croatian: Vanjska vrećica od aluminijske folije može se otvoriti u nesterilnom radnom okružju.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Na zahtjev Europske agencije za lijekove; • Uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: 3 years In use shelf life: Once the vial is opened Raplixa should be applied within 2 hours.
Croatian: Rok valjanosti pri uporabi: Nakon što se bočica jednom otvori, Raplixa se mora primijeniti u roku od 2 sata.
English: Name and address of the manufacturer responsible for batch release Nova Laboratories Limited
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Nova Laboratories Limited
English: In addition, the spray device should not be used closer than the recommended distances.
Croatian: Nadalje, raspršivač see ne smije koristiti s udaljenosti manje od preporučene.
English: The product should only be administered according to the instructions and with the devices recommended for this product.
Croatian: Lijek se smije primijeniti samo u skladu s uputama i s uređajima preporučenima za ovaj lijek.
English: Use and Application
Croatian: Uporaba i primjena
English: Clinical studies with Raplixa demonstrating haemostasis were conducted in patients undergoing spinal (n=146), vascular (n=137), liver (n=158) and soft tissue surgery (n=125).
Croatian: Klinička ispitivanja lijeka Raplixa koja pokazuju hemostazu provedena su u bolesnika podvrgnutih kirurškom zahvatu kralježnice (n= 146), vaskularnom kirurškom zahvatu (n= 137), kirurškom zahvatu jetre (n= 158) i mekog tkiva (n= 125).
English: • Risk of life-threatening air or gas embolism if the product is sprayed incorrectly
Croatian: • Riziku od po život opasne zračne ili plinske embolije ako se lijek nepravilno raspršuje
English: Inadvertent intravascular injection could lead to thromboembolic event and disseminated intravascular coagulation (DIC), and there is also a risk of anaphylactic reaction (see section 4.4).
Croatian: Nenamjerno intravaskularno ubrizgavanje može dovesti do tromboembolijskog događaja i diseminirane intravaskularne koagulacije (DIK), a postoji i rizik od anafilaktičke reakcije (vidjeti dio 4.4).
English: The surgeon treating you will administer Raplixa during surgery.
Croatian: Kirurg koji Vas liječi će primijeniti lijek Raplixa tijekom kirurškog zahvata.
English: Raplixa must not be injected into blood vessels because it would cause clots which could be fatal.
Croatian: Raplixa se ne smije ubrizgavati u krvne žile jer bi to moglo izazvati ugruške koji mogu biti kobni.
English: Raplixa is intended for epilesional use only.
Croatian: Raplixa je namijenjena samo za epilezijsku primjenu.
English: It is known from in vitro testing that 1 g can cover 100 cm² using the RaplixaSpray device.
Croatian: Ispitivanja in vitro pokazala su da 1 g može pokriti 100 cm² korištenjem uređaja RaplixaSpray.
English: • Use of the Raplixa spray device only in open surgery, not endoscopic surgery
Croatian: • Uporabi raspršivača lijeka Raplixa samo u otvorenim zahvatima, a ne u endoskopskoj kirurgiji
English: The risk appears to be higher when fibrin sealants are sprayed with air, as compared to CO2 and therefore cannot be excluded with Raplixa.
Croatian: Čini se da je rizik veći kada se fibrinska tkivna ljepila raspršuju zrakom, u usporedbi sa CO2 i stoga se ne može isključiti s lijekom Raplixa.
English: No data are available, Raplixa is therefore not recommended for use in children and adolescents.
Croatian: S obzirom da nema dostupnih podataka, lijek Raplixa se ne preporučuje za primjenu u djece i adolescenata.
English: The vial must be opened in a sterile field.
Croatian: Bočica se mora otvoriti u sterilnom području.
English: The required dose of Raplixa, can vary based on the size of the area to be treated.
Croatian: Potrebna doza lijeka Raplixa može varirati ovisno o veličini područja koje se tretira.
English: Active
Croatian: Aktivno
English: Conversion of fibrinogen into fibrin occurs by the splitting of fibrinogen into fibrin monomers and fibrinopeptides.
Croatian: Pretvorba fibrinogena u fibrin nastaje prelamanjem fibrinogena u fibrinske monomere i fibrinopeptide.
English: Animal reproduction studies have not been conducted with Raplixa.
Croatian: Nisu provedena ispitivanja reprodukcije na životinjama s lijekom Raplixa.
English: Raplixa may be denatured after exposure to solutions containing alcohol, iodine or heavy metals (e.g. antiseptic solutions).
Croatian: Raplixa se može denaturirati nakon izlaganja otopinama koje sadrže alkohol, jod ili teške metale (npr. antiseptičke otopine).
English: These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of viruses/infections.
Croatian: One uključuju pažljiv odabir donatora krvi i plazme kako bi se osiguralo da su rizični prenositelji infekcije isključeni, kao i testiranje svake donacije krvi i sakupljene plazme na znakove virusa/infekcija.
English: The required dose of Raplixa based on the size of the bleeding surface area to be treated is shown in the table below:
Croatian: Potrebna doza lijeka Raplixa na osnovi veličine površine krvarenja koju treba liječiti prikazana je u sljedećoj tablici:
English: What Raplixa is and what it is used for What you need to know before you are treated with Raplixa How to use Raplixa
Croatian: Što je Raplixa i za što se koristi Što morate znati prije nego dobijete lijek Raplixa Kako uzimati lijek Raplixa Moguće nuspojave
English: The educational programme is aimed at increasing awareness about the risk of air or gas embolism with the use of Raplixa spray device and providing instructions for the correct usage of pressure regulators.
Croatian: Svrha edukacijskog programa je povećati svijest o riziku zračne ili plinske embolije uz korištenje raspršivača Raplixa i dati upute za pravilnu uporabu regulatora tlaka.
English: This also applies to any unknown or emerging viruses, or other types of infections.
Croatian: To se također odnosi na nepoznate ili novonastale viruse te na druge vrste infekcija.
English: Trehalose Calcium chloride Albumin
Croatian: Kalcijev klorid Albumin
English: It is strongly recommended that every time you receive a dose of Raplixa the name and batch number of the medicine are recorded in order to maintain a record of the batches used.
Croatian: Preporučuje se svaki puta kad primite dozu lijeka Raplixa zabilježiti ime i broj serije lijeka, s ciljem održavanja evidencije o korištenim serijama.
English: Spray application of Raplixa must not be used in endoscopic or laparoscopic procedures.
Croatian: Primjena lijeka Raplixa raspršivanjem ne smije se koristiti u endoskopskim ili laparoskopskim postupcima.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Croatian: Standardne mjere za sprječavanje infekcija koje nastaju zbog primjene lijekova proizvedenih iz ljudske krvi ili plazme uključuju odabir donatora, probir individualnih donacija krvi i sakupljene plazme na specifične markere infekcija i provođenje učinkovitih koraka u proizvodnji kojima se inaktiviraju/uklanjaju virusi.
English: The measures taken in the manufacture of fibrinogen and thrombin are considered effective for lipid coated viruses such as HIV (human immunodeficiency virus), hepatitis B virus and hepatitis C virus.
Croatian: Mjere koje se poduzimaju u proizvodnji fibrinogena i trombina smatraju se učinkovitima protiv virusa obloženih lipidima kao što su HIV (virus humane imunodeficijencije), virus hepatitisa B i virus hepatitisa C.
English: The active ingredient fibrinogen is a concentrate of clottable protein; the other active ingredient thrombin is an enzyme that causes clottable protein to coalesce to form a plug.
Croatian: Djelatna tvar, fibrinogen, je koncentrat koagulacijskog proteina; druga djelatna tvar, trombin, je enzim koji uzrokuje spajanje koagulacijskog proteina radi formiranja čepa (ugruška).
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the application site, bronchospasm, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) may occur in isolated cases in patients treated with fibrin sealants / haemostatics: these reactions have progressed to severe anaphylaxis.
Croatian: Preosjetljivost ili alergijske reakcije (koje mogu uključivati angioedem, žarenje i probadanje na mjestu primjene, bronhospazam, zimicu, crvenilo uz osjećaj vrućine, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsima, trnce, povraćanje, zviždanje u plućima) mogu se pojaviti u izoliranim slučajevima u bolesnika liječenih fibrinskim tkivnim ljepilima/ hemostaticima: ove reakcije su uznapredovale do teške anafilaksije.
English: • When Raplixa is applied during surgery, the surgeon must ensure that it is only applied onto the surface of tissue.
Croatian: • Kad se Raplixa primjenjuje tijekom kirurškog zahvata, kirurg mora osigurati primjenu samo na površinu tkiva.
English: Raplixa must not be used as a glue for intestines (gastrointestinal anastomoses).
Croatian: Raplixa se ne smije koristiti kao tkivno ljepilo za crijeva (gastrointestinalne anastomoze).
English: • When medicines are made from human blood or plasma, certain measures are put into place to prevent infections being passed on to patients.
Croatian: • Kod lijekova proizvedenih iz ljudske krvi ili plazme, poduzete su određene mjere za sprječavanje prijenosa infekcija na bolesnike.
English: Maximum Surface Area Application Using RaplixaSpray
Croatian: Maksimalna površina područja Primjena uz pomoć uređaja RaplixaSpray
English: For instructions on use of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o uporabi lijeka prije primjene vidjeti dio 6.6.
English: • Use of Raplixa has only been shown to arrest bleeding in surgery visualized through the incision (open surgery).
Croatian: • Pokazalo se da Raplixa zaustavlja samo krvarenje pri kirurškom zahvatu koje je vidljivo kroz rez (otvoreni kirurški zahvat).
English: Raplixa should not be administered during pregnancy and breast-feeding.
Croatian: Raplixa se ne smije uzimati tijekom trudnoće i dojenja.
English: Raplixa is applied during surgical operations, to reduce bleeding and oozing during and after the operation in adults.
Croatian: Raplixa se primjenjuje tijekom kirurških zahvata kako bi se smanjilo krvarenje i eksudat tijekom i nakon kirurškog zahvata u odraslih.
English: Pharmacotherapeutic group: local haemostatics, other haemostatics ATC code: B02BC30
Croatian: FARMAKOLOŠKA SVOJSTVA 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: lokalni hemostatici, ostali hemostatici ATK oznaka: B02BC30
English: Source
Croatian: Izvor
English: liver resection, larger amounts may be required.
Croatian: Za neke postupke, npr. resekciju jetre, mogu biti potrebne veće količine.
English: Data are not available to support the use of this product in tissue gluing, neurosurgery, application through a flexible endoscope for treatment of bleeding or in gastrointestinal anastomoses.
Croatian: Podaci koji bi podržali uporabu ovog lijeka u lijepljenju tkiva, neurokirurgiji, primjeni uz pomoć fleksibilnog endoskopa za liječenje krvarenja ili za gastrointestinalne anastomoze nisu dostupni.
English: The use of Raplixa is restricted to experienced surgeons.
Croatian: Uporaba lijeka Raplixa ograničena je na iskusne kirurge.
English: The amount of Raplixa that will be applied depends on the surface area to be treated during the operation and the severity of the blood loss.
Croatian: Količina lijeka Raplixa koja će se primijeniti ovisi o površini koju treba liječiti tijekom kirurškog zahvata i težini krvarenja.
English: Once the vial is opened, use within 2 hours.
Croatian: Nakon otvaranja bočice upotrijebiti u roku od 2 sata.
English: Antibodies against components of fibrin sealant/haemostatic products may occur rarely.
Croatian: Protutijela protiv sastojaka fibrinskog tkivnog ljepila/hemostatika mogu se javiti rijetko.
English: Calcium ions are required for both, the conversion of fibrinogen and the crosslinkage of fibrin.
Croatian: Kalcijevi ioni su potrebni u oba slučaja, i pretvorbi fibrinogena i unakrsnog povezivanja fibrina.
English: The measures taken are considered effective for enveloped viruses such human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV).
Croatian: Poduzete mjere smatraju se učinkovitima za viruse s ovojnicom poput virusa humane imunodeficijencije (HIV), virusa hepatitisa B (HBV) i virusa hepatitisa C (HCV).
English: Tel: +353 1 6764971
Croatian: Fax: + 385 (0)1 4884 110
English: The spray device and the accessory nozzle are provided with instructions for use, which should be carefully followed.
Croatian: Raspršivač i dodatna mlaznica dolaze s uputama za uporabu, koje se moraju strogo slijediti.
English: • Requirement to dry the wound using standard techniques (e.g., intermittent application of compresses, swabs, use of suction devices) prior to using the product
Croatian: • Zahtjevu za sušenjem rane primjenom standardnih tehnika (primjerice naizmjeničnom primjenom kompresa, tupfera, korištenjem uređaja za aspiraciju) prije primjene lijeka
English: Blanchardstown
Croatian: Blanchardstown Dublin 15
English: There is limited experience of use of Raplixa in vascular surgery when applied with the RaplixaSpray device.
Croatian: Postoji ograničeno iskustvo korištenja lijeka Raplixa u vaskularnoj kirurgiji kad se primjenjuje uređajem RaplixaSpray.
English: As wound healing progresses, increased fibrinolytic activity is induced by plasmin and decomposition of fibrin to fibrin degradation products is initiated.
Croatian: Kako zacjeljivanje rane napreduje, raste fibrinolitička aktivnost potaknuta plazminom i pokreće razgradnju fibrina u razgrađene produkte fibrina.
English: • Guide for healthcare professionals
Croatian: • Sažetak opisa svojstava lijeka • Upute za zdravstvene djelatnike
English: Parvovirus B19 may be serious for pregnant women (fetal infection) and of individuals with immunodeficiency or increased erythropoiesis (e.g. Haemolytic anaemia).
Croatian: Parvovirus B19 može biti ozbiljan za trudnice (fetalna infekcija) i osobe s imunodeficijencijom ili povećanom eritropoezom (npr. hemolitička anemija).
English: In combination with a gelatin sponge, Raplixa is applied or sprayed onto cut tissue where it forms a layer that helps to stop bleeding.
Croatian: U kombinaciji sa želatinskom spužvicom, Raplixa se nanosi ili raspršuje na rez tkiva gdje stvara sloj koji pomaže zaustaviti krvarenje.
English: When spraying Raplixa, safety will be monitored because of the possibility of occurrence of air or gas embolism.
Croatian: Prilikom primjene lijeka Raplixa, nadzirat će se sigurnost primjene zbog mogućnosti pojave zračne ili plinske embolije.
English: The initial amount of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area with a thin layer of Raplixa which is then covered by an absorbable gelatin sponge (saline-wetted).
Croatian: Početna količina lijeka koja će se primijeniti na odabranom anatomskom mjestu ili ciljnoj površini trebala bi biti dovoljna da u potpunosti prekrije predviđeno područje primjene tankim slojem lijeka Raplixa koji se potom pokriva apsorbirajućom želatinskom spužvicom (namočenom fiziološkom otopinom).
English: When applying Raplixa using the recommended spray device, your surgeon must be sure to use a pressure and a distance from tissue within the range recommended by the manufacturer as follows:
Croatian: Kod primjene lijeka Raplixa preporučenim raspršivačem, kirurg mora biti siguran da su tlak i udaljenost od tkiva unutar raspona preporučenog od strane proizvođača kako slijedi:
English: Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (for example sickle cell disease or haemolytic anaemia).
Croatian: Infekcija parvovirusom B19 može biti ozbiljna za trudnice (fetalna infekcija) i osobe čiji je imunološki sustav oslabljen ili koji imaju neke vrste anemija (primjerice bolest srpastih stanica ili hemolitičku anemiju).
English: Raplixa has been studied in patients undergoing spinal surgery, vascular surgery, soft tissue surgery and hepatic resection.
Croatian: Raplixa je ispitivana u bolesnika podvrgnutih kirurškom zahvatu kralježnice, vaskularnom kirurškom zahvatu, kirurškom zahvatu mekog tkiva i jetrenoj resekciji.
English: Raplixa must not be applied intravascularly.
Croatian: Raplixa se ne smije primijeniti intravaskularno.
English: Raplixa and the device should be stored at controlled, ambient room temperature.
Croatian: Lijek Raplixa i uređaj moraju se čuvati na kontroliranoj, sobnoj temperaturi.
English: The measures may be of limited value against non- enveloped viruses such as HAV and parvovirus B19.
Croatian: Mjere mogu biti nedovoljne protiv virusa bez ovojnice, kao što su HAV i parvovirus B19.
English: Recommended spray pressure
Croatian: Preporučeni tlak pri raspršivanju
English: If you experience an allergic reaction you might have one or more of the following symptoms: skin rash, hives or wheals (nettle-rash), tightness of the chest, chills, flushing, headache, low blood pressure, lethargy, nausea, restlessness, increased heart rate, tingling, vomiting or wheezing.
Croatian: U slučaju alergijske reakcije, možete imati jedan ili više sljedećih simptoma: kožni osip, koprivnjaču, stezanje u prsima, zimicu, crvenilo uz osjećaj vrućine, glavobolju, nizak krvni tlak, pospanost, mučninu, nemir, povećani broj otkucaja srca, trnce, povraćanje ili zviždanje u plućima.
English: Sodium chloride Sodium citrate L-arginine-hydrochloride
Croatian: Natrijev klorid Natrijev citrat L-arginin-hidroklorid
English: Gelatin sponges are CE marked and separately supplied and packed (see instructions for use for the specific gelatin sponge selected for use).
Croatian: Želatinske spužvice imaju oznaku CE i zasebno se isporučuju i pakiraju (vidjeti upute za uporabu posebne želatinske spužvice odabrane za uporabu).
English: The gelatin sponges should be handled and used according to the manufacturer's instructions in the package insert that accompanies the gelatin sponge.
Croatian: Želatinskim spužvicama treba rukovati i koristiti ih u skladu s uputama proizvođača sadržanima u uputi koja se isporučuje uz želatinsku spužvicu.
English: • Which regulator(s) should be used, in line with manufacturer recommendations and the SmPC
Croatian: • Koji se regulator(i) moraju koristiti, u skladu s preporukama proizvođača i uputama za uporabu sadržanima u Sažetku opisa svojstava lijeka
English: Application must be within 2 hours after connecting the vial to the device.
Croatian: Primjena mora biti u roku od 2 sata nakon spajanja bočice s uređajem.
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Croatian: Unatoč tim mjerama, kod primjene lijekova proizvedenih od ljudske krvi ili plazme, mogućnost prijenosa infekcije ne može se potpuno isključiti.