natgillin/translations-raw huggingface dataset:
• With one hand tightly grasp the Respreeza vial as shown in Figure 5.
• Z eno roko močno primite vialo z zdravilom Respreeza kot je prikazano na sliki 5.
Such studies are not considered meaningful due to the production of antibodies against the heterologous human protein in animals.
Take študije se ne zdijo smiselne zaradi nastajanja protiteles proti heterolognim človeškim beljakovinam pri živalih.
Do not use solutions that are discoloured, cloudy or have particles.
Ne uporabljajte raztopin, ki so obarvane, motne ali imajo delce.
Respreeza is made from human blood plasma (this is the liquid part of the blood with the blood cells removed).
Zdravilo Respreeza je narejeno iz človeške krvne plazme (to je tekoči del krvi z odstranjenimi krvnimi celicami).
The safety of Respreeza has been assessed in several preclinical studies.
Varnost zdravila Respreeza je bila ovrednotena v več predkliničnih študijah.
Therefore, Respreeza may have a minor influence on the ability to drive and use machines.
Zato ima lahko zdravilo Respreeza blag vpliv na sposobnost vožnje in upravljanja strojev.
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.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali zdravstvenim delavcem, preden vzamete to zdravilo.
If your doctor decides that you are suitable for such home-treatment / selfadministration, he or she will instruct you in:
Če se zdravnik odloči, da ste primerni za zdravljenje doma/samoinfundiranje, vas bo poučil glede naslednjega:
One vial of Respreeza is for single use only.
Ena viala zdravila Respreeza je samo za enkratno uporabo.
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.
Če boste za potrebni odmerek potrebovali več kot 1 vialo zdravila Respreeza, ponovite zgornja navodila od 1 do 11 z dodatnim pakiranjem, ki vsebuje neuporabljen komplet Mix2Vial.
• Obligation to conduct post-authorisation measures
• Obveznosti izvedbe ukrepov po pridobitvi dovoljenja za promet
If you experience dizziness, you should not drive or use machines until the dizziness has passed (see section 4).
Če se pojavi omotica, ne vozite ali upravljajte strojev, dokler omotica ne mine (glejte poglavje 4).
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.
Ker je kajenje tobaka pomemben dejavnik tveganja za razvoj in napredovanje emfizema, vam močno priporočamo, da nehate kaditi in se izogibate pasivnemu kajenju.
In case of shock, emergency medical treatment should be administered.
Pri šoku je treba uvesti nujno zdravljenje.
Proceed with your next dose immediately and continue at regular intervals as advised by your doctor or healthcare professional.
Takoj nadaljujte z naslednjim odmerkom, nato pa nadaljujte v rednih intervalih, kot vam je svetoval zdravnik ali zdravstveni delavec.
The amount of Respreeza you are given is based on your body weight.
Količina zdravila Respreeza, ki jo boste prejeli, je odvisna od vaše telesne mase.
•how to prepare and givethis medicine (see the illustrated instructions at the end of this leaflet in
•kako pripraviti in dajati to zdravilo (glejte navodila z risbami na koncu tega navodila v
If this is not possible, solutions can be stored up to 3 hours at room temperature (up to 25 °C).
Če to ni mogoče, lahko raztopino do 3 ure shranjujete pri sobni temperaturi (do 25°C).
The recommended infusion rate given under section 4.2 should be adhered.
Upoštevati je treba hitrost infundiranja, priporočeno v poglavju 4.2.
Conditions that increase neutrophil accumulation and activation in the lung, such as respiratory infection and smoking, will in turn increase levels of NE.
Pogoji, ki povečajo kopičenje in aktiviranje nevtrofilcev v pljučih, kot sta okužba dihal in kajenje, povečajo raven NE.
Take care not to touch the rubber vial stopper.
Pazite, da se ne dotaknete gumijastega zamaška viale.
If treatment with Respreeza is stopped, your condition may worsen.
Če se prenehate zdraviti z zdravilom Respreeza, se lahko stanje poslabša.
• if you have been found to have a deficiency of certain blood proteins called immunoglobulin type A (IgA) and have developed antibodies against them.
• če je bilo ugotovljeno, da imate pomanjkanje določene krvne beljakovine, imenovane imunoglobulin tipa (IgA) in so se pri vas razvila protitelesa proti njim.
However, Respreeza should be given with caution to pregnant women.
Kljub temu je treba zdravilo Respreeza nosečnicam dajati previdno.
This leaflet was last revised in MM/YYYY.
Navodilo je bilo nazadnje revidirano dne MM/LLLL
Consequences of overdose are unknown.
Posledice prevelikega odmerjanja niso znane.
What you need to know before you use Respreeza 3.
Kaj morate vedeti, preden boste uporabili zdravilo Respreeza 3.
Pediatric population
Pediatrična populacija
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.4).
• Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 (glejte tudi poglavje 4.4).
For detailed information regarding the administration of the reconstituted solution, see the instructions at the end of section 6.6.
Za podrobne informacije glede dajanja rekonstituirane raztopine glejte navodila na koncu poglavja 6.6.
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.
V primeru prevelikega odmerjanja je treba bolnika skrbno opazovati zaradi pojava neželenih učinkov; na voljo morajo biti ustrezni podporni ukrepi.
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.
Standardni ukrepi za preprečevanje okužb zaradi uporabe zdravil, pripravljenih iz človeške krvi ali plazme, vključujejo izbiro darovalcev, presejanje posameznih odvzetih enot in združene plazme za specifične označevalce okužbe in vključevanje učinkovitih proizvodnih korakov za inaktivacijo/odstranitev virusov.
Information on allergic reactions: when slowing or stopping the infusion may be required?
Informacije o alergijskih reakcijah: kdaj bo morda treba infundiranje upočasniti ali ustaviti?
Hypersensitivity or allergic reactions have been observed during the treatment.
Med zdravljenjem so opazili preobčutljivostne ali alergijske reakcije.
Table 1 shows the mean results for the Respreeza pharmacokinetic parameters.
V preglednici 1 so prikazani povprečni rezultati za farmakokinetične parametre zdravila Respreeza.
144 (±27) µM x day
144 (± 27) µM x dan
6.5 Nature and contents of container and special equipment for administration
6.5 Vrsta ovojnine in vsebina ter posebna oprema za dajanje
Other medicines and Respreeza
Druga zdravila in zdravilo Respreeza
“Information for health-care professionals and for patients suitable for home-treatment / self administration”)
"Informacije za zdravstvene delavce in bolnike, ki so primerni za zdravljenje doma/samoinfundiranje"),
A population pharmacokinetic analysis was conducted using data from 90 Respreeza-treated subjects from the RAPID trial.
Analiza populacijske farmakokinetike je bila izvedena s podatki 90 oseb, zdravljenih z zdravilom Respreeza, iz preskušanja RAPID.
• The powder must be reconstituted with solvent (water for injections).
• Prašek je treba rekonstituirati z vehiklom (voda za injekcije).
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).
Varnost in učinkovitost zdravila Respreeza so ocenili v randomizirani, dvojno slepi, s placebom nadzorovani multicentrični študiji (RAPID), ki ji je sledil 2-letni odprt podaljšek študije (podaljšek študije RAPID).
A total of 13 post-infusion serum samples were taken at various time points up to Day 21.
Do 21. dne je bilo odvzetih skupaj 13 vzorcev seruma po infundiranju ob različnih časovnih točkah.
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.
Vendar pa informacij o varnosti uporabe zdravila Respreeza med nosečnostjo ni, zato vam morajo to zdravilo, če ste noseči, dajati previdno.
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).
Pogostnost na bolnika (na podlagi šestmesečne izpostavljenosti med kliničnimi preskušanji) je bila ocenjena po naslednjem dogovoru: pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (1/10.000 do <1/1.000) in zelo redki (<1/10.000).
What Respreeza is and what it is used for 2.
Kaj je zdravilo Respreeza in za kaj ga uporabljamo 2.
The water for injections will automatically flow into the Respreeza vial.
Voda za injekcije bo samodejno stekla v vialo z zdravilom Respreeza.
The reconstituted solution has an approximate osmolality of 279 mOsmol / kg and a pH of 7.0.
Rekonstituirana raztopina ima približno osmolalnost 279 mOsmol/kg in pH 7,0.
If symptoms subside promptly after stopping, the infusion may be resumed at a lower rate that is comfortable for the patient.
Če se simptomi kmalu po prenehanju dajanja poležejo, se lahko z infundiranjem nadaljuje z manjšo hitrostjo, ki je za bolnika ugodna.
Pharmacotherapeutic group: Antihemorrhagics, proteinase inhibitor, ATC code: B02AB02
Farmakoterapevtska skupina: antihemoragiki, zaviralci proteinaz, oznaka ATC: B02AB02
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).
V najresnejših primerih lahko alergijske reakcije napredujejo do hudih anafilaktičnih reakcij, čeprav bolnik ni bil preobčutljiv na predhodna dajanja (glejte poglavje 4.4).
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.
V nekaterih zelo redkih primerih lahko napredujejo (pojavijo se lahko pri največ 1 od 10.000 bolnikov) do hudih alergijskih reakcij, čeprav pri prejšnjem infundiranju niste kazali nobenih znakov alergije.
5.1 (±2.4) days
5,1 (± 2,4) dni
• the testing of samples of donated blood and plasma to try to avoid use of material with signs of virus/infections,
• testiranje vzorcev darovane krvi in plazme, da se poskusi preprečiti uporaba materialov z znaki virusov/okužb,
NOTE: Ensure all water has transferred into the Respreeza vial.
OPOMBA: Poskrbite, da se je vsa voda prenesla v vialo z zdravilom Respreeza.
Your doctor or healthcare professional will take that into consideration if you are on a controlled sodium diet.
Zdravnik ali zdravstveni delavec bo to upošteval, če ste na dieti z nadziranim vnosom natrija.
Home treatment / Self-administration
Zdravljenje doma/samoinfundiranje
However chemical and physical in-use stability has been demonstrated for 3 h at room temperature (up to 25 °C).
Kemična in fizikalna stabilnost med uporabo sta bili dokazani za 3 ure pri sobni temperaturi (do 25 °C).
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).
Prašek je treba rekonstituirati z vodo za injekcije (glejte navodila za rekonstitucijo v poglavju 6.6) in aplicirati z intravenskim priborom (ni priloženo).
If you forget to use Respreeza
Če ste pozabili uporabiti zdravilo Respreeza
There, its main function is to protect the lung tissue by limiting the action of a certain enzyme, called neutrophil elastase.
Tam je njegova glavna funkcija zaščita pljučnega tkiva z omejevanjem delovanja določenega encima, imenovanega nevtrofilna elastaza.
Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived proteinase inhibitors.
Zdravnik vam bo morda priporočil cepljenje proti virusom hepatitisa A in B, če redno/večkrat prejemate humane zaviralce proteinaze, pridobljene iz človeške plazme.
RAPID studies
Študiji RAPID
Total clearance
Skupni očistek
Inject/infuse the reconstituted solution into the vein following the instructions given to you by your doctor.
Rekonstituirano raztopino si injicirajte/infundirajte v veno po navodilih, ki ste jih prejeli od zdravnika.
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.
Bolniki s selektivnim ali hudim pomanjkanjem IgA lahko razvijejo protitelesa proti IgA in imajo zato večje tveganje za razvoj potencialno hude preobčutljivosti in anafilaktičnih reakcij.
There are limited data regarding the use of this medicinal product in home-treatment / selfadministration.
Podatki o uporabi tega zdravila pri zdravljenju doma/samoinfundiranju so omejeni.
Single doses of 120 mg / kg bw have been administered to 137 subjects treated with Respreeza.
Enojne odmerke 120 mg/kg telesne mase so dajali 137 osebam, zdravljenim z zdravilom Respreeza.
The following information is intended for health-care professionals and for patients suitable for home-treatment / self-administration
Naslednje informacije so namenjene zdravstvenemu osebju in bolnikom, ki so primerni za zdravljenje doma/samoinfundiranje
• Total reconstitution of the powder should be obtained within 5 minutes (1 g presentation) or 10
• Celotno rekonstitucijo praška je treba izvesti v 5 minutah (jakost 1 g) ali v 10 minutah (jakost
That should be taken into consideration for patients on a controlled sodium diet.
To morajo upoštevati bolniki, ki so na dieti z nadzorovanim vnosom natrija.
During the first infusions, patient's clinical state, including vital signs, should be closely monitored throughout the infusion period.
Med prvim infundiranjem je treba ves čas infundiranja skrbno nadzirati bolnikovo klinično stanje, vključno z življenjskimi znaki.
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.
Možna tveganja, povezana z zdravljenjem doma/samoinfundiranjem, so povezana z ravnanjem z zdravilom in dajanjem zdravila in z obravnavo neželenih učinkov, zlasti preobčutljivosti.
Tell your doctor or healthcare professional if you think you have used more Respreeza as you should.
Zdravniku ali zdravstvenemu delavcu povejte, če menite, da ste uporabili več zdravila Respreeza, kot bi smeli.
Respreeza may contain trace amounts of IgA.
Zdravilo Respreeza lahko vsebuje sledove IgA.
Your doctor will determine the appropriate infusion rate for you by taking into account your weight and your tolerability to infusion.
Zdravnik bo določil ustrezno hitrost infundiranja ob upoštevanju vaše telesne mase in vašega prenašanja infuzije.
Subsequent infusions can be administered by a caregiver or by the patient (see section 4.4).
Naslednje infuzije lahko daje negovalec ali si jih daje bolnik sam (glejte poglavje 4.4).
What you need to know before you use Respreeza
Kaj morate vedeti, preden boste uporabili zdravilo Respreeza
Anaphylactic reactions
anafilaktične reakcije
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.
Odločitev o tem, ali je bolnik primeren za zdravljenje doma/samoinfundiranje, bo sprejel lečeči zdravnik, ki mora zagotoviti ustrezno usposabljanje (npr. glede rekonstitucije, uporabe kompleta Mix2Vial, priprave intravenskih cevk, tehnik infundiranja, vodenja dnevnika zdravljenja, identifikacije neželenih učinkov in ukrepov, ki so potrebni pri pojavu takih reakcij) in pregled uporabe v rednih časovnih intervalih.
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.
Če se pojavijo reakcije, ki bi lahko bile povezane z dajanjem zdravila Respreeza, je treba hitrost infundiranja zmanjšati ali ustaviti dajanje, kot narekuje klinično stanje bolnika.
- If you have any further questions, ask your doctor or healthcare professional.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali zdravstvenim delavcem.
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.
Vendar pa posamezniki s pomanjkanjem endogenega zaviralca alfa1-proteinaze ne morejo ohranjati ustrezne obrambe proti proteazi, zato se hitreje pojavi proteoliza alveolarnih sten, ki se začne pred razvojem klinično vidne kronične obstruktivne pljučne bolezni v tretjem ali četrtem desetletju.
In a subgroup of subjects enrolled in this study (10 Respreeza-treated subjects) broncho-alveolar lavage was performed.
V podskupini oseb, vključenih v to študijo (10 oseb, zdravljenih z zdravilom Respreeza), je bil izveden bronhoalveolarni izpirek.
Neutrophil elastase can cause damage if its action is not controlled (for example, in case you have an alpha1-proteinase inhibitor deficiency).
Nevtrofilna elastaza lahko povzroči poškodbe, če njeno delovanje ni nadzorovano (na primer pri pomanjkanju zaviralca alfa1-proteinaze).
The excretion of human alpha1-proteinase inhibitor in milk has not been studied in animals.
Izločanja humanega zaviralca alfa1-proteinaze v mleko pri živalih niso preučili.
Figure 1: Changes in Lung Density (TLC) from baseline in the RAPID and RAPID Extension studies
Slika 1: Spremembe v pljučni kapaciteti (TLC) od izhodišča v študiji RAPID in podaljšku študije RAPID
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.
V dvojno slepi, nadzorovani klinični študiji za ocenitev varnosti in biokemične učinkovitosti zdravila Respreeza je bilo 44 oseb randomiziranih za prejemanje 60 mg/kg telesne mase intravenskega odmerka zdravila Respreeza enkrat na teden za 24 tednov.
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.
Odločitev o nadaljevanju/prenehanju dojenja ali nadaljevanju/prenehanju zdravljenja z zdravilom Respreeza je treba sprejeti ob upoštevanju dejavnikov prednosti dojenja za otroka in prednosti terapije s humanim zaviralcem alfa1-proteinaze za mater.
• IgA deficient patients with known antibodies against IgA, due to the risk of severe hypersensitivity and anaphylactic reactions.
• Bolniki s pomanjkanjem IgA, za katere je znano, da imajo protitelesa proti IgA, zaradi tveganja hudih preobčutljivostnih in anafilaktičnih reakcij.
The other ingredients are sodium chloride, sodium dihydrogen phosphate monohydrate and mannitol (see last paragraph of section 2).
Druge sestavine zdravila so natrijev klorid, natrijev dihidrogen fosfat monohidrat in manitol (glejte zadnji odstavek poglavja 2).
• careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,
•skrbna izbira darovalcev krvi in plazme, da se zagotovi izključitev tveganj za prenos okužb,
• the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.
• vključitev korakov priprave krvi in plazme, kjer se virusi inaktivirajo ali odstranijo.
Area under the curve (AUC0-∞)
Površina pod krivuljo (AUC, area under the curve0-∞)
Four clinical studies were conducted with Respreeza in 89 subjects (59 males and 30 females) to evaluate the effect of Respreeza on serum levels of alpha1-proteinase inhibitor.
Z zdravilom Respreeza so izvedli štiri klinične študije z 89 osebami (59 moških in 30 žensk) za ocenitev učinka zdravila Respreeza na ravni zaviralca alfa1-proteinaze v serumu.
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.
Ker se s krvjo prenašajo okužbe, obstajajo pri zdravilih, izdelanih iz človeške krvi ali plazme, določeni ukrepi za preprečevanje njihove prisotnosti v zdravilu in njihovo prenašanje na bolnike.
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).
Neželeni učinki so zbrani iz šestih kliničnih študij pri 221 bolnikih in iz izkušenj v obdobju trženja ter predstavljeni v spodnji preglednici v skladu z organskimi sistemi po MedDRA (organski sistemi in prednostni izraz).
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.
Bolniki morajo biti na optimalnem farmakološkem in nefarmakološkem zdravljenju in kazati znake progresivne pljučne bolezni (npr. nizek napovedan forsirani ekspiratorni volumen na sekundo (FEV1), okvarjena zmožnost hoje ali povečano število eksacerbacij), kar oceni zdravstveni delavec z izkušnjami v zdravljenju pomanjkanja zaviralca alfa1-proteinaze.
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.
Analiza populacijske farmakokinetike ni pokazala nobenih pomembnih učinkov starosti, spola, telesne mase ali izhodiščne koncentracije antigenskega zaviralca alfa1-proteinaze v serumu na očistek zdravila Respreeza.
Use a separate, unused Mix2Vial set, and a water for injections vial for each Respreeza vial.
Uporabite ločen, neuporabljen komplet Mix2Vial, in vialo z vodo za injekcije za vsako vialo z zdravilom Respreeza.
How to store Respreeza 6.
Kako uporabljati zdravilo Respreeza 4.
Hyperhidrosis, pruritus
hiperhidroza, pruritus oteklost obraza
Some side effects may be serious: Uncommonly (may affect up to 1 in 100 people), allergic reactions have been observed.
Nekateri neželeni učinki so lahko resni: Občasno (pojavijo se lahko pri največ 1 od 100 bolnikov) so opazili alergijske reakcije.
It is strongly recommended that every time that Respreeza is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Močno se priporoča, da vsakokrat, ko damo bolniku zdravilo Respreeza zabeležimo ime in številko serije zdravila, da tako vzdržujemo povezavo med bolnikom in serijo zdravila.