natgillin/translations-raw huggingface dataset:
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.
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.
Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards.
Pažljivo uklonite blister pakiranje sa Mix2Vial seta držeći ga za rub i povlačeći okomito prema gore.
If this is not possible, solutions can be stored up to 3 hours at room temperature (up to 25 °C).
Ako to nije moguće otopinu se može čuvati na sobnoj temperaturi (do 25 °C) najviše 3 sata.
Subsequent infusions can be administered by a caregiver or by the patient (see section 4.4).
Sljedeće infuzije može primijeniti njegovatelj ili sam bolesnik (vidjeti dio 4.4).
• Bend the entire Mix2Vial set to the side until it disconnects from the Respreeza vial (Figure 5).
• Savijte cijeli Mix2Vial set na stranu dok se ne odvoji od Respreeza bočice (Slika 5).
From a microbiological point of view, the product should be used immediately after reconstitution.
S mikrobiološkog stajališta otopinu treba primijeniti odmah nakon rekonstitucije.
The infusion solution is normally given over about 15 minutes (about 0.08 ml of solution per kg body weight each min).
Infuzijska otopina obično se daje tijekom 15 minuta (oko 0,08 ml otopine po kg tjelesne težine svake min).
However, Respreeza should be given with caution to pregnant women.
Ipak, Respreeza se u trudnica treba primjenjivati uz oprez.
Do NOT take Respreeza
NEMOJTE primjenjivati Respreezu
Ensure that the Respreeza vial and water for injections vial are at room temperature (up to 25°C).
Pobrinite se da su Respreeza bočica i bočica s vodom za injekcije sobne temperature (do 25°C).
The other ingredients are sodium chloride, sodium dihydrogen phosphate monohydrate and mannitol (see last paragraph of section 2).
Drugi sastojci su natrijev klorid, natrijev dihidrogenfosfat hidrat i manitol (vidjeti zadnji odlomak dijela 2).
If you forget to use Respreeza
Ako ste zaboravili primijeniti Respreezu
The excretion of human alpha1-proteinase inhibitor in milk has not been studied in animals.
Izlučivanje ljudskog inhibitora alfa1-proteinaze u mlijeko nije ispitivano na životinjama.
In case of self-administration / home-treatment, stop the infusion immediately and contact your doctor or healthcare professional.
U slučaju samoprimjene/liječenja kod kuće odmah zaustavite infuziju i javite se svome liječniku ili zdravstvenom radniku.
The population pharmacokinetic analysis did not indicate that there were any significant effects of age, gender, weight, or baseline serum antigenic alpha1-proteinase inhibitor concentrations on the clearance of Respreeza.
Populacijska farmakokinetička analiza nije ukazala na bilo kakve značajne učinke dobi, spola,težine ili početne serumske koncentracije antigenog inhibitora alfa1-proteinaze na klirens Respreeze.
Human alpha1-proteinase inhibitor has a molecular weight of 51 kDa and belongs to the family of serine protease inhibitors.
Ljudski inhibitor alfa1-proteinaze ima molekularnu težinu od 51 kDa i pripada obitelji inhibitora serinskih proteaza.
The powder must be reconstituted with water for injections (see instructions on reconstitution in section°6.6) and administered using an intravenous administration set (not supplied).
Prašak se mora rekonstituirati s vodom za injekcije (vidjeti upute za rekonstituciju u dijelu 6.6) te primijeniti koristeći set za intravensku primjenu (nije isporučen).
A double-blind, randomized, active-controlled, crossover pharmacokinetic study was conducted in 13 males and 5 females with alpha1-proteinase inhibitor deficiency, ranging in age from 36 to 66 years.
Dvostruko slijepo, randomizirano, kontrolirano aktivnim lijekom, ukriženo farmakokinetičko ispitivanje provedeno je na 13 muškaraca i 5 žena s nedostatkom inhibitora alfa1-proteinaze, dobi u rasponu od 36 do 66 godina.
Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived proteinase inhibitors.
Vaš liječnik Vam može preporučiti da razmotrite cijepljenje protiv hepatitisa A i B ako redovito/ponavljano primate ljudske inhibitore proteinaza iz plazme.
The following information is intended for health-care professionals and for patients suitable for home-treatment / self-administration
Sljedeće informacije namijenjene su zdravstvenim radnicima i bolesnicima pogodnim za liječenje kod kuće/samoprimjenu
The safety and efficacy of Respreeza in the paediatric population (below 18 years) have not been established.
Sigurnost i djelotvornost Respreeze u pedijatrijskoj populaciji (ispod 18 godina) nisu još ustanovljene.
• the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.
• uključivanje koraka koji mogu inaktivirati ili ukloniti viruse pri obradi krvi ili plazme.
Follow steps below to remove entire Mix2Vial set from Respreeza vial:
Slijedite korake u nastavku kako biste uklonili cijeli Mix2Vial set od Respreeza bočice:
Do not remove the Mix2Vial set from the blister package.
Nemojte vaditi Mix2Vial set iz blister pakiranja.
The MAH shall complete, within the stated timeframe, the below measures: Description
Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere:
Asthenia, infusion-site reactions (including infusion site hematoma)
Astenija, reakcije na mjestu primjene infuzije (uključujući hematom na mjestu primjene infuzije)
The annual rate of lung density decline, as measured by CT scan at total lung capacity (TLC) over 2 years was lower with Respreeza (-1.45 g/L) as compared with placebo (-2.19 g/L), reflecting a 34% reduction (p = 0.017, 1-sided).
Godišnja stopa smanjenja gustoće plućnog tkiva, mjerena CT-om pri ukupnom kapacitetu pluća (TLC) tijekom 2 godine bila je niža uz Respreezu (-1,45 g/l) u usporedbi s placebom (-2,19 g/l), što je smanjenje od 34% (p = 0,017, jednostrani).
Potential risks associated with home-treatment / self-administration are related to the handling and administration of the medicinal product as well as to the handling of adverse reactions, particularly hypersensitivity.
Mogući rizici povezani s liječenjem kod kuće/samoprimjenom vezani su uz rukovanje i primjenu lijeka kao i uz zbrinjavanje nuspojava, posebice preosjetljivosti.
The measures taken are considered effective for viruses such as human immunodeficiency virus (HIV), hepatitis A virus, hepatitis B virus, hepatitis C virus, and parvovirus B19 virus.
Mjere koje se provode smatraju se učinkovitima za viruse kao što su virus humane imunodeficijencije (HIV), virus hepatitisa A , virus hepatitisa B, virus hepatitisa C te parvovirus B19.
However, individuals deficient in endogenous alpha1-proteinase inhibitor are unable to maintain appropriate antiprotease defence and experience more rapid proteolysis of the alveolar walls starting prior to the development of clinically evident chronic obstructive lung disease in the third or fourth decade.
Međutim, pojedinci koji imaju nedostatak endogenog inhibitora alfa1-proteinaze ne mogu podržati odgovarajuć antiproteazni odgovor te kod njih dolazi do ubrzane proteolize alveolarnih stijenki koja nastupa prije razvoja klinički vidljive kronične opstruktivne bolesti pluća u trećem ili četvrtom desetljeću.
Gently swirl the Respreeza vial until the powder is completely dissolved (Figure 6).
Nježno vrtite Respreeza bočicu dok se prašak potpuno ne otopi (Slika 6).
• IgA deficient patients with known antibodies against IgA, due to the risk of severe hypersensitivity and anaphylactic reactions.
• Bolesnici s nedostatkom IgA za koje je poznato da imaju protutijela na IgA, zbog rizika od ozbiljne preosjetljivosti i anafilaktičkih reakcija.
After the first infusions, you or your caregiver might also administer Respreeza, but only after receiving adequate training.
Nakon prvih infuzija, ali samo nakon odgovarajuće obuke, Vi i Vaš njegovatelj ćete također moći primjenjivati Respreezu.
OUTER BOX
VANJSKA KUTIJA
If you stop using Respreeza
Ako prestanete primjenjivati Respreezu
Patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second (FEV1) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.
Bolesnici trebaju biti optimalno farmakološki i nefarmakološki liječeni i imati dokaze progresivne plućne bolesti (npr. predviđeno snižavanje forsiranog ekspiratornog volumena po sekundi (FEV1), smanjen kapacitet za hodanje, povećan broj egzacerbacija) procijenjeno od strane zdravstvenog radnika iskusnog u liječenju nedostatka inhibitora alfa1-proteinaze.
The European Medicines Agency has waived the obligation to submit the results of studies with Respreeza in all subsets of the pediatric population in chronic obstructive pulmonary disease (COPD) due to alpha1-proteinase inhibitor deficiency (see section 4.2 for information on pediatric use).
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Respreeza u svim podskupinama pedijatrijske populacije za kroničnu opstruktivnu plućnu bolest (KOPB) zbog nedostatka inhibitora alfa1-proteinaze (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Depending on the nature and severity of the reaction, your doctor may decide whether to slow or stop the infusion completely and start the appropriate treatment.
Ovisno o prirodi i težini reakcije Vaš liječnik može odlučiti usporiti ili potpuno zaustaviti infuziju i započeti odgovarajuće liječenje.
Table 1: Pharmacokinetic parameters for alpha1-proteinase inhibitor following a single 60 mg / kg bw dose of Respreeza Pharmacokinetic Parameter
Tablica 1: Farmakokinetički parametri za inhibitor alfa1-proteinaze nakon jednostruke doze Respreeze od 60 mg/kg TT Farmakokinetički parametar
At screening, serum alpha1-proteinase inhibitor levels were between 3.2 and 10.1 M (mean of 5.6 M).
Pri probiru, serumske razine inhibitora alfa1-proteinaze bile su između 3,2 i 10,1 M (srednja vrijednost 5,6 M).
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) and for the non-enveloped hepatitis A (HAV) and parvovirus B19 virus.
Mjere koje se provode smatraju se učinkovitima za viruse s ovojnicom kao što su virus humane imunodeficijencije (HIV), virus hepatitisa B (HBV) i virus hepatitisa C (HCV) te za viruse bez ovojnice virus hepatitisa A (HAV) i parvovirus B19.
• 1°transfer set 20/20 (Mix2Vial set) for reconstitution
• 1 set za prijenos 20/20 (Mix2Vial set) za rekonstituciju
Remove the plastic flip-top cap from the Respreeza vial.
Uklonite plastičnu flip-top kapicu s Respreeza bočice.
Emphysema develops when the lack of alpha1-proteinase inhibitor results in a condition in which neutrophil elastase is not being properly controlled, damaging the tiny air sacs in the lungs through which oxygen passes into the body.
Emfizem se razvije kada nedostatak inhibitora alfa1-proteinaze dovede do stanja u kojem neutrofilna elastaza nije odgovarajuće kontrolirana te oštećuje sitne zračne mjehuriće u plućima preko kojih kisik prelazi u tijelo.
Any unused medicinal product or waste material should be disposed as instructed by your doctor or healthcare professional.
Sav neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno uputama Vašeg liječnika ili zdravstvenog radnika.
It is unknown whether Respreeza / metabolites are excreted in human milk.
Nije poznato izlučuju li se Respreeza/metaboliti u majčino mlijeko.
That should be taken into consideration for patients on a controlled sodium diet.
Navedeno treba uzeti u obzir u bolesnika na dijeti s kontroliranim unosom natrija.
No animal reproduction studies have been conducted with Respreeza and its safety for use in human pregnancy has not been established in controlled clinical trials.
Nisu provedena reproduktivna ispitivanja uz Respreezu na životinjama te sigurnost primjene u trudnica nije ustanovljena u kontroliranim kliničkim ispitivanjima.
The decision of whether a patient is suitable for home-treatment / self-administration is made by the treating doctor, who should ensure appropriate training is provided (e.g. regarding reconstitution, use of Mix2Vial set, assembly of intravenous tubing, infusion techniques, maintenance of a treatment diary, identification of adverse reactions and measures to be taken in case such reactions occur) and the use is reviewed at regular intervals.
Odluku o pogodnosti bolesnika za liječenje kod kuće/samoprimjenu donosi ordinirajući liječnik, koji se treba pobrinuti za pružanje odgovarajućeg osposobljavanja (npr. za rekonstituciju, korištenje Mix2Vial seta, sastavljanje infuzijskih cjevčica, tehnike infuzije, vođenje dnevnika liječenja, uočavanje nuspojava i poduzimanje mjera ako se pojave) i redovitu provjeru korištenja.
NOTE: Ensure all water has transferred into the Respreeza vial.
Provjerite je li sva voda prebačena u Respreeza bočicu.
Place the water for injections vial on an even, clean surface and hold the vial tight.
Stavite bočicu s vodom za injekcije na ravnu, čistu površinu i čvrsto držite bočicu.
It is unknown whether Respreeza passes into human milk.
Nije poznato prelazi li Respreeza u majčino mlijeko.
The recommended dose is 60 mg per kg of body weight and should be administered once per week.
Preporučena doza je 60 mg po kg tjelesne težine i treba se primjenjivati jednom tjedno.
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived proteinase inhibitors.
Treba razmotriti odgovarajuće cijepljenje (protiv hepatitisa A i B) za bolesnike koji redovito/ponavljano primaju ljudske inhibitore proteinaze dobivene iz plazme.
Respreeza should only be administered intravenously by infusion after reconstitution.
Respreeza se smije primjenjivati samo intravenskom infuzijom nakon rekonstitucije.
Nine subjects received a single 60 mg / kg bw dose of Respreeza followed by a comparator product, and 9 subjects received comparator product followed by a single 60 mg / kg bw dose of Respreeza, with a wash-out period of 35 days between doses.
Devet ispitanika primilo je jednokratnu dozu od 60 mg/kg TT Respreeze i nakon toga usporedni lijek, a devet ispitanika je primilo usporedni lijek i nakon toga jednokratnu dozu od 60 mg/kg TT Respreeze, s periodom ispiranja od 35 dana između doza.
Pediatric population
Pedijatrijska populacija
No animal fertility studies have been conducted with Respreeza and its effect on human fertility has not been established in controlled clinical trials.
Nisu provedena ispitivanja plodnosti uz Respreezu na životinjama te utjecaj na ljudsku plodnost nije ustanovljen u kontroliranim kliničkim ispitivanjima.
Because blood can carry infections, when medicines are made from human blood or plasma certain measures are put in place to prevent these from being present in the medicine and passed on to patients.
Budući da se krvlju mogu prenijeti infekcije, pri pravljenju lijekova iz ljudske krvi ili plazme provode se određene mjere kako bi se spriječio prijenos infekcija putem lijeka na bolesnike.
• Total reconstitution of the powder should be obtained within 5 minutes (1 g presentation) or 10 minutes (4 g and 5 g presentation).
• Potpunu rekonstituciju praška treba postići unutar 5 minuta (pakiranje od 1 g) ili 10 minuta (pakiranje od 4 g i 5 g).
The safety and efficacy of Respreeza in elderly patients (65 years of age or older) have not been established in clinical trials.
Sigurnost i djelotvornost Respreeze u starijih bolesnika (u dobi od 65 godina ili starijih) nisu ustanovljene u kliničkim ispitivanjima.
After it has been reconstituted with water for injections, the solution should be clear, colourless to slightly yellow and free from visible particles.
Nakon što se rekonstituira pomoću vode za injekcije, otopina treba biti bistra, bezbojna do blago žuta i bez vidljivih čestica.
In a double-blind, controlled clinical study to evaluate the safety and biochemical efficacy of Respreeza 44 subjects were randomized to receive 60 mg / kg bw intravenous dose of Respreeza once weekly for 24 weeks.
U dvostruko slijepom, kontroliranom kliničkom ispitivanju za procjenu sigurnosti i biokemijske djelotvornosti Respreeze 44 ispitanika bila su randomizirana kako bi primala intravensku dozu Respreeze od 60 mg/kg TT jednom tjedno tijekom 24 tjedna.
The adverse reactions (ARs) collected from six clinical studies in 221 patients and post-marketing experience are presented in the table below according to the MedDRA System organ classification (SOC and Preferred Term (PT) Level).
Nuspojave prikupljene iz šest kliničkih ispitivanja na 221 bolesniku te iz razdoblja nakon stavljanja lijeka u promet prikazane su u tablici ispod, prema MedDRA klasifikaciji organskih sustava (SOC, (engl.
Following the completion of the RAPID study, an analysis of achieved median alpha1-proteinase inhibitor levels and lung density decline was conducted.
Nakon završetka RAPID ispitivanja, provedena je analiza postignutih medijana razina inhibitora alfa1-proteinaze i smanjenja gustoće plućnog tkiva.
Very rarely (may affect up to 1 in 10,000 people) Decreased sense of touch like burning, tingling or feeling of numbness in your hands, arms, legs, or feet (hypoaesthesia), excessive sweating (hyperhidrosis), itching, chest pain, chills, fever (pyrexia).
Vrlo rijetko (mogu se javiti u do 1 na 10 000 osoba) Oslabljen osjet dodira kao osjećaj pečenja, žarenja ili utrnulosti u šakama, rukama, nogama ili stopalima (hipoestezija), prekomjerno znojenje (hiperhidroza), svrbež, bolovi u prsima, zimica, vrućica (pireksija).
• careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,
• pažljivi odabir davatelja krvi i plazme kako bi bili sigurni da je rizik prijenosa infekcija isključen,
The studies investigated the effect of Respreeza on the progression of emphysema, assessed by the decline of lung density, measured by computer tomography (CT).
U ispitivanjima je istraženo djelovanje Respreeze na progresiju emfizema, što je procijenjeno smanjenjem gustoće plućnog tkiva mjerene kompjutoriziranom tomografijom (CT-om).
Excipients with known effect Respreeza contains approximately 1.9 mg sodium per ml of reconstituted solution (81 mmol/l).
Pomoćne tvari s poznatim učinkom Respreeza sadrži približno 1,9 mg natrija po ml rekonstituirane otopine (81 mmol/l).
Dizziness may occur following the administration of Respreeza (see section 4.8).
Nakon primjene Respreeze može se javiti omaglica (vidjeti dio 4.8).
The RAPID extension study demonstrated that the reduced rate in lung density decline was maintained for subjects continuously treated with Respreeza for 4 years (see Figure 1).
Nastavak RAPID ispitivanja pokazao je da je snižena stopa smanjenja gustoće plućnog tkiva održana u ispitanika koji su kontinuirano liječeni Respreezom tijekom 4 godine (vidjeti sliku 1).
Patients with renal or hepatic impairment
Bolesnici s bubrežnim ili jetrenim oštećenjem
If any reaction takes place that might be related to the administration of Respreeza, the rate of infusion should be decreased or the administration should be stopped, as required by the clinical condition of the patient.
Ako se pojava bilo koje reakcije može povezati s primjenom Respreeze, brzinu infuzije treba smanjiti ili posve zaustaviti primjenu, ovisno o kliničkom stanju bolesnika.
The model predicted mean steady-state concentration was 21.8 µM after a 60 mg /kg bw / week dose.
Srednja vrijednost koncentracije u ravnotežnom stanju predviđena modelom bila je 21,8 µM nakon doze od 60 mg/kg TT/tjedno.
Depending on the nature and severity of the reaction, your doctor or healthcare professional may decide whether to slow or stop the administration completely and give appropriate treatment for the reaction.
Ovisno o prirodi i težini reakcije Vaš liječnik ili zdravstveni radnik može odlučiti usporiti ili potpuno zaustaviti infuziju i dati Vam odgovarajuću terapiju za reakciju.
The safety and efficacy of Respreeza in elderly patients (65 years of age or older) have not been established in specific clinical trials.
Sigurnost i djelotvornost Respreeze u starijih bolesnika (u dobi od 65 godina i starijih) nisu ustanovljene posebnim kliničkim ispitivanjima.
Do not use this medicine after the expiry date which is stated on the outer carton and the vial labels after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskoj kutiji i naljepnicama na bočicama iza oznake „Rok valjanosti“.
The safety of Respreeza has been assessed in several preclinical studies.
Sigurnost Respreeze procijenjena je u nekoliko nekliničkih ispitivanja.
The reconstituted solution must be administered using an intravenous administration set (not supplied).
Rekonstituirana otopina mora se primijeniti korištenjem seta za intravensku primjenu (nije isporučen).
Your doctor will inform you about signs of allergic reactions (for example chills, flushing, faster heartbeat, fall in blood pressure, light-headedness, rash, hives, itching, difficulty in breathing or swallowing as well as swelling of your hands, face, or mouth) (see also section 4).
Vaš će Vas liječnik obavijestiti o znakovima alergijskih reakcija (na primjer zimicu, crvenilo, brže kucanje srca, pad krvnog tlaka, ošamućenost, osip, koprivnjaču, svrbež, otežano disanje ili gutanje, kao i oticanje šaka, lica ili usta) (vidjeti također dio 4).
Normal healthy individuals produce sufficient alpha1-proteinase inhibitor to control the NE produced by activated neutrophils and are thus able to prevent inappropriate proteolysis of lung tissue by NE.
Prosječni zdravi pojedinci proizvode dovoljno inhibitora alfa1-proteinaze za kontrolu NE koju proizvode aktivirani neutrofili te zato mogu spriječiti neodgovarajuću proteolizu tkiva pluća.
The solution should be infused at an infusion rate of about 0.08 ml per kg body weight each min, as determined by your response and your comfort.
Otopinu treba primijeniti infuzijom brzinom od otprilike 0,08 ml po kg tjelesne težine svake minute, ovisno o Vašem odgovoru i ugodnosti.
Since human alpha1-proteinase inhibitor is a protein and a physiological constituent of human blood, it is not expected to present carcinogenic, genotoxic, or teratogenic effects.
Budući da je ljuski inhibitor alfa1-proteinaze protein i fiziološka sastavnica ljudske krvi, ne očekuju se kancerogeni, genotoksični ili teratogeni učinci.
Respreeza-treated subjects demonstrated a consistent pattern of slower lung density decline than those receiving placebo (see Figure 1).
Bolesnici liječeni Respreezom dosljedno su pokazivali sporije smanjenje gustoće tkiva nego oni koji su primali placebo (vidjeti Sliku 1).
Respreeza is indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes PiZZ, PiZ(null), Pi(null,null), PiSZ).
Respreeza je indicirana za terapiju održavanja kako bi se usporila progresija emfizema u odraslih s dokazanim teškim nedostatkom inhibitora alfa1-proteinaze (npr. genotipovi PiZZ, PiZ-nul, Pi-nul-nul, PiSZ).
Frequency not known (frequency cannot be estimated from the available data) Pain to the lymph glands (oval-shaped masses of tissue that are distributed throughout the body and which may be palpable for example in the armpit, groinor neck), swollen face, swollen eyes and lips.
Nepoznata učestalost (učestalost se ne može procijeniti iz dostupnih podataka) Bol u limfnim čvorovima (ovalne nakupine tkiva raspoređene po cijelom tijelu koje se mogu napipati, na primjer u pazuhu, preponama ili na vratu), oticanje lica, oticanje očiju i usana.
What Respreeza contains
Što Respreeza sadrži
Do not use solutions that are discoloured, cloudy or have particles.
Nemojte primijeniti otopine koje su promijenile boju, zamućene su ili imaju vidljive čestice.