FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine is not for use in children or adolescents below 18years of age.
Croatian: Ovaj lijek nije za primjenu u djece ili adolescenata mlađih od 18 godina.
English: This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Croatian: Lijek se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6.
English: The population estimate of mean half-life was 6.8 days.
Croatian: Procijenjena srednja vrijednost poluživota u populaciji bio je 6,8 dana.
English: No special investigations have been performed.
Croatian: Nisu provedena posebna ispitivanja.
English: Mean (standard deviation)*
Croatian: Srednja vrijednost (standardna devijacija)*
English: The subjects ranged in age from 29 to 68 years (median age 49 years).
Croatian: Dob ispitanika bila je u rasponu od 29 do 68 godina (medijan dobi 49 godina).
English: Information on safety with respect to infections
Croatian: Informacije o sigurnosti s obzirom na infekcije
English: • Do not use provided sterile ancillaries for reconstitution if their package is opened or if they are damaged.
Croatian: • Nemojte koristiti isporučene sterilne pomoćne dijelove za rekonstituciju ako je njihovo pakiranje otvoreno ili ako su oštećeni.
English: Terminal half-life (t1/2ß)
Croatian: Terminalni poluživot (t1/2ß)
English: This also applies to unknown or emerging viruses and other pathogens.
Croatian: To se također odnosi i na nepoznate i nove viruse te druge patogene.
English: In some cases severe allergic reactions may occur.
Croatian: U nekim slučajevima može doći do teških alergijskih reakcija.
English: Area under the curve (AUC0-∞)
Croatian: Površina ispod krivulje (AUC0-∞)
English: However, as there is no information available regarding the safety of Respreeza use during pregnancy, if you are pregnant, this medicine should only be given to you with caution.
Croatian: Ipak, budući da nema dostupnih podataka o sigurnosti primjene Respreeze tijekom trudnoće, ako ste trudni ovaj Vam se lijek može dati samo uz oprez.
English: 603 (±129) mL/day
Croatian: 603 (±129) ml/dan
English: • how to keep a treatment diary
Croatian: • kako voditi dnevnik liječenja
English: Non-clinical data reveal no special risk for humans based on safety pharmacology and short term toxicity studies.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju ispitivanja sigurnosne farmakologije i kratkoročne toksičnosti.
English: Hyperhidrosis, pruritus
Croatian: Hiperhidroza, pruritus
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or healthcare professional for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili zdravstvenom radniku za savjet prije nego uzmete ovaj lijek.
English: Close the roller clamp.
Croatian: Zatvorite rotirajuću stezaljku.
English: Urticaria, rash (including exfoliative and generalized)
Croatian: Urtikarija, osip (uključujući eksfolijativni i generalizirani)
English: Other medicines and Respreeza
Croatian: Drugi lijekovi i Respreeza
English: If treatment with Respreeza is stopped, your condition may worsen.
Croatian: Ako se liječenje Respreezom prekine, stanje Vam se može pogoršati.
English: In case of shock, emergency medical treatment should be administered.
Croatian: U slučaju šoka, potrebno je primijeniti hitno liječenje.
English: If your doctor decides that you are suitable for such home-treatment / selfadministration, he or she will instruct you in:
Croatian: Ako Vaš liječnik/liječnica odluči da ste pogodni za takvo liječenje kod kuće/samoprimjenu uputit će Vas:
English: Tell your doctor or healthcare professional if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili zdravstvenog radnika ako uzimate,nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Information on allergic reactions: when slowing or stopping the infusion may be required?
Croatian: Informacija o alergijskim reakcijama: kada može biti potrebno usporavanje ili zaustavljanje infuzije?
English: RAPID studies
Croatian: RAPID ispitivanja
English: What Respreeza is and what it is used for 2.
Croatian: Što je Respreeza i za što se koristi 2.
English: Consequences of overdose are unknown.
Croatian: Posljedice predoziranja nisu poznate.
English: • The powder must be reconstituted with solvent (water for injections).
Croatian: • Prašak se mora rekonstituirati s otapalom (voda za injekcije).
English: •how to prepare and givethis medicine (see the illustrated instructions at the end of this leaflet in
Croatian: • kako pripremiti i dati ovaj lijek (pogledajte ilustrirane upute na kraju ove upute pod naslovom
English: Your doctor will determine the appropriate infusion rate for you by taking into account your weight and your tolerability to infusion.
Croatian: Vaš će liječnik odrediti odgovarajuću brzinu infuzije za Vas, uzimajući u obzir Vašu težinu, i podnošenje infuzije.
English: 6.5 Nature and contents of container and special equipment for administration
Croatian: 6.5 Vrsta i sadržaj spremnika i posebna oprema za primjenu
English: Repeat dose toxicity studies longer than 5 days, reproductive toxicity studies and carcinogenicity studies, have not been performed.
Croatian: Ispitivanja toksičnosti ponovljenih doza dulja od 5 dana, ispitivanja reproduktivne toksičnosti i ispitivanja kancerogenosti nisu provedena.
English: What Respreeza looks like and contents of the pack
Croatian: Kako Respreeza izgleda i sadržaj pakiranja
English: What you need to know before you use Respreeza
Croatian: Što morate znati prije nego počnete primjenjivati Respreezu
English: Your doctor or healthcare professional will take that into consideration if you are on a controlled sodium diet.
Croatian: Vaš će liječnik ili zdravstveni radnik uzeti to u obzir ako ste na dijeti s kontroliranim unosom natrija.
English: Tobacco smoke is an important risk factor for the development and progression of emphysema.
Croatian: Pušenje duhana je važan rizični čimbenik za razvoj i progresiju emfizema.
English: If you are breast-feeding, your doctor will discuss with you the risks and benefits of taking this medicine.
Croatian: Ako dojite Vaš će liječnik s Vama razmotriti rizike i dobrobit od uzimanja ovog lijeka.
English: Table 1 shows the mean results for the Respreeza pharmacokinetic parameters.
Croatian: Tablica 1 pokazuje srednje vrijednosti rezultata za farmakokinetičke parametre Respreeze.
English: • The product must be reconstituted, administered and handled with caution using aseptic technique to maintain product sterility.
Croatian: • Lijek se mora oprezno rekonstituirati, primijeniti i njime rukovati uz primjenu aseptične tehnike kako bi se održala sterilnost lijeka.
English: If you experience dizziness, you should not drive or use machines until the dizziness has passed (see section 4).
Croatian: Ako osjetite omaglicu ne smijete upravljati vozilima ili raditi sa strojevima dok omaglica ne prođe (vidjeti dio 4).
English: Patients should be informed of signs of hypersensitivity reactions.
Croatian: Bolesnici trebaju biti upoznati sa znakovima reakcija preosjetljivosti.
English: No alternative dose regimen can be recommended in those patients.
Croatian: U ovih se bolesnika ne može preporučiti alternativni režim doziranja.
English: • how to keep the product sterile (aseptic infusion techniques)
Croatian: • u održavanje sterilnosti lijeka (aseptične tehnike davanja infuzije)
English: • With one hand tightly grasp the Respreeza vial as shown in Figure 5.
Croatian: • Jednom rukom čvrsto uhvatite Respreeza bočicu kako je prikazano na Slici 5.
English: The frequency of ARs during post marketing only is considered as “not known (cannot be estimated from the available data)”.
Croatian: Učestalost nuspojava nakon stavljanja lijeka u promet okarakterizirana je kao „nepoznato (ne može se procijeniti iz dostupnih podataka)“.
English: Inspect visually the reconstituted solution.
Croatian: Vizualno pregledajte rekonstituiranu otopinu.
English: Since tobacco smoke is an important risk factor for the development and progression of emphysema, you are strongly advised to stop smoking and avoid passive smoking.
Croatian: Budući da je pušenje duhana važan rizični čimbenik za razvoj i napredovanje emfizema morate prestati pušiti i izbjegavati pasivno pušenje.
English: Frequency per patient (based on six months of exposure during clinical trials) has been evaluated according to the following convention: common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Croatian: Učestalost po bolesniku (na temelju šest mjeseci izloženosti tijekom kliničkih ispitivanja) procijenjena je u skladu sa sljedećom konvencijom: često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000) i vrlo rijetko (<1/10 000).
English: This medicine is a white to off-white powder.
Croatian: Ovaj lijek je bijeli do bjelkasti prašak.
English: Hypersensitivity or allergic reactions have been observed during the treatment.
Croatian: Tijekom liječenja su uočene preosjetljivost ili alergijske reakcije.
English: Paediatric Population Safety and effectiveness in the paediatric population have not been established.
Croatian: Pedijatrijska populacija Sigurnost i učinkovitost u pedijatrijskoj populaciji nisu ustanovljene.
English: 144 (±27) µM x day
Croatian: 144 (±27) µM x dan
English: The water for injections will automatically flow into the Respreeza vial.
Croatian: Voda za injekcije automatski će poteći u Respreeza bočicu.
English: Such studies are not considered meaningful due to the production of antibodies against the heterologous human protein in animals.
Croatian: Takva ispitivanja ne smatraju se značajnima zbog stvaranja protutijela protiv heterolognih ljudskih proteina u životinja.
English: In the event of overdose, the patient should be observed closely for the occurrence of adverse reactions and supportive measures should be available as necessary.
Croatian: U slučaju predoziranja bolesnika treba pažljivo nadzirati zbog pojave nuspojava i trebaju biti dostupne potporne mjere prema potrebi.
English: Therefore cessation of smoking and the avoidance of environmental tobacco smoke are strongly recommended.
Croatian: Zbog toga se svakako preporučuje prestanak pušenja i izbjegavanje duhanskog dima u okolini.
English: Do no stop using this medicine without consulting your doctor or healthcare professional.
Croatian: Nemojte prestati primjenjivati ovaj lijek bez savjetovanja sa svojim liječnikom ili zdravstvenim radnikom.
English: Make sure that the roller clamp on the administration set is closed.
Croatian: Pobrinite se da rotirajuća stezaljka na setu za primjenu bude zatvorena.
English: Slowly open the roller clamp on the administration set and let Respreeza flow until it reaches the end of the tubing with no air bubbles.
Croatian: Polako otvorite rotirajuću stezaljku na setu za primjenu i pustite da Respreeza teče dok ne dosegne kraj cjevčice bez mjehurića zraka.
English: The safety and efficacy of Respreeza was evaluated in a randomized, double-blind, placebocontrolled, multi-center study (RAPID) followed by a 2-year open-label extension study (RAPID extension study).
Croatian: Sigurnost i djelotvornost Respreeze procijenjena je u randomiziranom, dvostruko slijepom, placebom kontroliranom, multicentričnom ispitivanju (RAPID) nakon kojeg je slijedio 2-godišnji otvoreni nastavak ispitivanja (nastavak RAPID ispitivanja).
English: The amount of Respreeza you are given is based on your body weight.
Croatian: Količina Respreeze koja će Vam se dati određuje se na temelju
English: If more than 1 vial of Respreeza is needed to achieve the required dose, repeat instructions 1 to 11 above using an additional package containing an unused Mix2Vial set.
Croatian: Ako je potrebno više od jedne Respreeza bočice kako bi se postigla potrebna doza, ponovite postupak prema uputama od 1. do 11. koristeći dodatno pakiranje s neiskorištenim Mix2Vial setom.
English: Hypersensitivity reactions (including tachycardia, hypotension, confusion, syncope, oxygen consumption decreased and pharyngeal oedema)
Croatian: Reakcije preosjetljivosti (uključujući tahikardiju, hipotenziju, konfuziju, sinkopu, smanjenu potrošnju kisika i faringealni edem)
English: In the most serious cases, allergic reactions may progress to severe anaphylactic reactions even when the patient has shown no hypersensitivity to previous administrations (see section 4.4).
Croatian: U najtežim slučajevima, alergijske reakcije mogu progredirati u teške anafilaktičke reakcije čak i kad bolesnik nije pokazivao preosjetljivost pri prethodnim primjenama (vidjeti dio 4.4).
English: They may progress in some very rare cases (may affect up to 1 in 10,000 people) to severe allergic reactions even when you have shown no signs of allergy on previous infusions.
Croatian: U nekim vrlo rijetkim slučajevima (mogu se javiti u do 1 na 10 000 osoba) one se mogu razviti u teške alergijske reakcije čak i ako pri prethodnim infuzijama niste pokazivali znakove alergije.
English: If symptoms subside promptly after stopping, the infusion may be resumed at a lower rate that is comfortable for the patient.
Croatian: Ako se simptomi nakon zaustavljanja brzo povuku, infuziju se može nastaviti manjom brzinom koja je ugodna za bolesnika.
English: Therefore, Respreeza may have a minor influence on the ability to drive and use machines.
Croatian: Zbog toga Respreeza može malo utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: A total of 13 post-infusion serum samples were taken at various time points up to Day 21.
Croatian: Ukupno je uzeto 13 uzoraka seruma u različitim vremenskim točkama nakon infuzije do 21. dana.
English: For detailed information regarding the administration of the reconstituted solution, see the instructions at the end of section 6.6.
Croatian: Za detaljne informacije o primjeni rekonstituirane otopine vidjeti upute na kraju dijela 6.6.
English: Volume of distribution at steady state
Croatian: Volumen distribucije u ravnotežnom stanju
English: Talk to your doctor or healthcare professional before using Respreeza.
Croatian: Obratite se svom liječniku ili zdravstvenom radniku prije nego primijenite Respreezu.
English: “Information for health-care professionals and for patients suitable for home-treatment / self administration”)
Croatian: "Informacije za zdravstvene radnike i bolesnike pogodne za liječenje kod kuće/samoprimjenu")
English: Pharmacotherapeutic group: Antihemorrhagics, proteinase inhibitor, ATC code: B02AB02
Croatian: Farmakoterapijska skupina: Antihemoragici, inhibitor proteinaze, ATK oznaka: B02AB02
English: • if you are allergic to human alpha1-proteinase inhibitor or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na ljudski inhibitor alfa1-proteinaze ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Respreeza is made from human blood plasma (this is the liquid part of the blood with the blood cells removed).
Croatian: Respreeza se dobiva iz ljudske krvne plazme (to je tekući dio krvi bez krvnih stanica).
English: After reconstitution, Respreeza is given by infusion into a vein.
Croatian: Nakon rekonstitucije, Respreeza se daje infuzijom u venu.
English: The reconstituted solution has an approximate osmolality of 279 mOsmol / kg and a pH of 7.0.
Croatian: Rekonstituirana otopina ima osmolalnost približno 279 mOsmol/kg i pH 7,0.
English: However chemical and physical in-use stability has been demonstrated for 3 h at room temperature (up to 25 °C).
Croatian: Ipak, kemijska i fizikalna stabilnost u primjeni održana je tijekom 3 sata pri sobnoj temperaturi (do 25°C).
English: Do not freeze the reconstituted solution.
Croatian: Ne zamrzavajte rekonstituiranu otopinu.
English: Make sure that you only pull away the blister package and not the Mix2Vial set (Figure 3).
Croatian: Pazite da povlačite samo blister pakiranje, a ne Mix2Vial set (Slika 3).
English: The other side effects may include:
Croatian: Ostale nuspojave mogu uključivati:
English: Proceed with your next dose immediately and continue at regular intervals as advised by your doctor or healthcare professional.
Croatian: Odmah primijenite sljedeću dozu i zatim nastavite u pravilnim razmacima kako Vam je preporučio Vaš liječnik ili zdravstveni radnik.
English: • The reconstitution should be performed according to the instructions provided below.
Croatian: • Rekonstitucija treba biti provedena u skladu s uputama u nastavku.
English: • how to identify side effects, including signs of allergic reactions, and measures to be taken in case such effects occur (see also section 2 and section 4) Your doctor or your healthcare professional will regularly review your / your caregiver's infusion technique to ensure continued appropriate handling.
Croatian: • kako prepoznati nuspojave, uključujući znakove alergijskih reakcija i mjera koje je potrebno poduzeti ako do njih dođe (vidjeti također dijelove 2 i 4) Vaš će liječnik ili zdravstveni radnik redovito provjeriti tehniku davanja infuzije koju koristite Vi ili Vaš njegovatelj, kako bi se osiguralo daljnje odgovarajuće rukovanje.
English: There, its main function is to protect the lung tissue by limiting the action of a certain enzyme, called neutrophil elastase.
Croatian: Ondje je njegova glavna uloga zaštita tkiva pluća ograničavanjem djelovanja određenog enzima po imenu neutrofilna elastaza.
English: A population pharmacokinetic analysis was conducted using data from 90 Respreeza-treated subjects from the RAPID trial.
Croatian: Populacijska farmakokinetička analiza provedena je na podacima za 90 ispitanika liječenih Respreezom u RAPID ispitivanju.
English: Conditions that increase neutrophil accumulation and activation in the lung, such as respiratory infection and smoking, will in turn increase levels of NE.
Croatian: Stanja koja povećavaju nakupljanje neutrofila i njihovu aktivaciju u plućima, kao što su respiratorne infekcije i pušenje, uzrokuju povećanje razine NE.
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 prevenciju infekcija do kojih dolazi primjenom lijekova pripravljenih od ljudske krvi ili plazme uključuju selekciju donora, testiranje individualnih donacija i izvora plazme na specifične markere infekcija te provođenje učinkovitih proizvodnih koraka za inaktivaciju/uklanjanje virusa.
English: Neutrophil elastase can cause damage if its action is not controlled (for example, in case you have an alpha1-proteinase inhibitor deficiency).
Croatian: Neutrofilna elastaza može uzrokovati oštećenje pluća ako njezino djelovanje nije kontrolirano (na primjer, u slučaju da imate nedostatak inhibitora alfa1-proteinaze).
English: In a subgroup of subjects enrolled in this study (10 Respreeza-treated subjects) broncho-alveolar lavage was performed.
Croatian: U podskupini ispitanika uključenih u ovo ispitivanje (10 ispitanika liječenih Respreezom) učinjena je bronhoalveolarna lavaža.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.4).
Croatian: • Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 (vidjeti također dio 4.4).
English: Follow the steps provided below for the preparation and reconstitution of Respreeza:
Croatian: Slijedite korake u nastavku za pripremu i rekonstituciju Respreeze:
English: Inject/infuse the reconstituted solution into the vein following the instructions given to you by your doctor.
Croatian: 7. Injicirajte/primijenite infuzijom rekonstituiranu otopinu u venu prema uputama koje Vam je dao Vaš liječnik.
English: Take care not to touch the rubber vial stopper.
Croatian: Pazite da ne dirate gumeni čep bočice.
English: Home treatment / Self-administration
Croatian: Liječenje kod kuće/samoprimjena
English: After reconstitution, the solution should be used immediately.
Croatian: Nakon rekonstitucije, otopinu treba odmah upotrijebiti.
English: Single doses of 120 mg / kg bw have been administered to 137 subjects treated with Respreeza.
Croatian: Jednokratne doze od 120 mg/kg TT primijenjene su u 137 ispitanika liječenih Respreezom.
English: What Respreeza is and what it is used for
Croatian: Što je Respreeza i za što se koristi
English: Because of this damage, the lungs do not work properly.
Croatian: Zbog tog oštećenja funkcija pluća bude poremećena.
English: Suspected allergic or anaphylactic type reactions may require immediate discontinuation of the infusion, depending on the nature and severity of the reaction.
Croatian: Sumnja na alergijski ili anafilaktički tip reakcija može zahtijevati hitan prekid infuzije, ovisno o prirodi i težini reakcije.
English: Respreeza may contain trace amounts of IgA.
Croatian: Respreeza može sadržavati IgA u tragovima.
English: Use a separate, unused Mix2Vial set, and a water for injections vial for each Respreeza vial.
Croatian: Koristite zasebni, neiskorišteni Mix2Vial set i bočicu s vodom za injekcije za svaku Respreeza bočicu.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Respreeza should be made, taking into account the benefit of breast-feeding to the child and the benefit of human alpha1proteinase inhibitor therapy to the woman.
Croatian: Potrebno je odlučiti da li nastaviti/prekinuti dojenje ili nastaviti/prekinuti liječenje lijekom Respreeza uzimajući u obzir korist dojenja za dijete i korist od liječenja ljudskim inhibitorom alfa1-proteinaze za ženu.
English: • the testing of samples of donated blood and plasma to try to avoid use of material with signs of virus/infections,
Croatian: • provjera uzoraka donirane krvi i plazme kako bi se izbjegla uporaba materijala sa naznakama virusa/infekcija,
English: Use aseptic technique to transfer the reconstituted solutions into the administration container (e.g., empty intravenous bag or glass bottle; (not supplied) via a commercially available intravenous fluid tubing transfer set (not supplied)).
Croatian: Koristite aseptičnu tehniku za prijenos rekonstituiranih otopina u spremnik za primjenu (npr. praznu intravensku vrećicu ili staklenu bocu (nije isporučeno); putem na tržištu dostupnog seta cjevčica za prijenos intravenskih tekućina (nije isporučen)).
English: Patients with selective or severe IgA deficiency can develop antibodies to IgA and, therefore, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.
Croatian: Bolesnici sa selektivnim ili teškim nedostatkom IgA mogu razviti antitijela na IgA i stoga imaju veći rizik od nastanka potencijalno teške preosjetljivosti i anafilaktičkih reakcija.
English: Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards.
Croatian: Pažljivo uklonite blister pakiranje sa Mix2Vial seta držeći ga za rub i povlačeći okomito prema gore.
English: If this is not possible, solutions can be stored up to 3 hours at room temperature (up to 25 °C).
Croatian: Ako to nije moguće otopinu se može čuvati na sobnoj temperaturi (do 25 °C) najviše 3 sata.
English: Subsequent infusions can be administered by a caregiver or by the patient (see section 4.4).
Croatian: Sljedeće infuzije može primijeniti njegovatelj ili sam bolesnik (vidjeti dio 4.4).
English: • Bend the entire Mix2Vial set to the side until it disconnects from the Respreeza vial (Figure 5).
Croatian: • Savijte cijeli Mix2Vial set na stranu dok se ne odvoji od Respreeza bočice (Slika 5).
English: From a microbiological point of view, the product should be used immediately after reconstitution.
Croatian: S mikrobiološkog stajališta otopinu treba primijeniti odmah nakon rekonstitucije.