FrancophonIA/ELRC3.0 huggingface dataset:
English: Single doses of 120 mg / kg bw have been administered to 137 subjects treated with Respreeza.
Slovenian: Enojne odmerke 120 mg/kg telesne mase so dajali 137 osebam, zdravljenim z zdravilom Respreeza.
English: The following information is intended for health-care professionals and for patients suitable for home-treatment / self-administration
Slovenian: Naslednje informacije so namenjene zdravstvenemu osebju in bolnikom, ki so primerni za zdravljenje doma/samoinfundiranje
English: • Total reconstitution of the powder should be obtained within 5 minutes (1 g presentation) or 10
Slovenian: • Celotno rekonstitucijo praška je treba izvesti v 5 minutah (jakost 1 g) ali v 10 minutah (jakost
English: That should be taken into consideration for patients on a controlled sodium diet.
Slovenian: To morajo upoštevati bolniki, ki so na dieti z nadzorovanim vnosom natrija.
English: During the first infusions, patient's clinical state, including vital signs, should be closely monitored throughout the infusion period.
Slovenian: Med prvim infundiranjem je treba ves čas infundiranja skrbno nadzirati bolnikovo klinično stanje, vključno z življenjskimi znaki.
English: 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.
Slovenian: Možna tveganja, povezana z zdravljenjem doma/samoinfundiranjem, so povezana z ravnanjem z zdravilom in dajanjem zdravila in z obravnavo neželenih učinkov, zlasti preobčutljivosti.
English: Tell your doctor or healthcare professional if you think you have used more Respreeza as you should.
Slovenian: Zdravniku ali zdravstvenemu delavcu povejte, če menite, da ste uporabili več zdravila Respreeza, kot bi smeli.
English: Respreeza may contain trace amounts of IgA.
Slovenian: Zdravilo Respreeza lahko vsebuje sledove IgA.
English: Your doctor will determine the appropriate infusion rate for you by taking into account your weight and your tolerability to infusion.
Slovenian: Zdravnik bo določil ustrezno hitrost infundiranja ob upoštevanju vaše telesne mase in vašega prenašanja infuzije.
English: Subsequent infusions can be administered by a caregiver or by the patient (see section 4.4).
Slovenian: Naslednje infuzije lahko daje negovalec ali si jih daje bolnik sam (glejte poglavje 4.4).
English: What you need to know before you use Respreeza
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Respreeza
English: Anaphylactic reactions
Slovenian: anafilaktične reakcije
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: - If you have any further questions, ask your doctor or healthcare professional.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali zdravstvenim delavcem.
English: 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.
Slovenian: 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.
English: In a subgroup of subjects enrolled in this study (10 Respreeza-treated subjects) broncho-alveolar lavage was performed.
Slovenian: V podskupini oseb, vključenih v to študijo (10 oseb, zdravljenih z zdravilom Respreeza), je bil izveden bronhoalveolarni izpirek.
English: Neutrophil elastase can cause damage if its action is not controlled (for example, in case you have an alpha1-proteinase inhibitor deficiency).
Slovenian: Nevtrofilna elastaza lahko povzroči poškodbe, če njeno delovanje ni nadzorovano (na primer pri pomanjkanju zaviralca alfa1-proteinaze).
English: The excretion of human alpha1-proteinase inhibitor in milk has not been studied in animals.
Slovenian: Izločanja humanega zaviralca alfa1-proteinaze v mleko pri živalih niso preučili.
English: Figure 1: Changes in Lung Density (TLC) from baseline in the RAPID and RAPID Extension studies
Slovenian: Slika 1: Spremembe v pljučni kapaciteti (TLC) od izhodišča v študiji RAPID in podaljšku študije RAPID
English: 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.
Slovenian: 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.
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.
Slovenian: 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.
English: • IgA deficient patients with known antibodies against IgA, due to the risk of severe hypersensitivity and anaphylactic reactions.
Slovenian: • Bolniki s pomanjkanjem IgA, za katere je znano, da imajo protitelesa proti IgA, zaradi tveganja hudih preobčutljivostnih in anafilaktičnih reakcij.
English: The other ingredients are sodium chloride, sodium dihydrogen phosphate monohydrate and mannitol (see last paragraph of section 2).
Slovenian: Druge sestavine zdravila so natrijev klorid, natrijev dihidrogen fosfat monohidrat in manitol (glejte zadnji odstavek poglavja 2).
English: • careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,
Slovenian: •skrbna izbira darovalcev krvi in plazme, da se zagotovi izključitev tveganj za prenos okužb,
English: • the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.
Slovenian: • vključitev korakov priprave krvi in plazme, kjer se virusi inaktivirajo ali odstranijo.
English: Area under the curve (AUC0-∞)
Slovenian: Površina pod krivuljo (AUC, area under the curve0-∞)
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Use a separate, unused Mix2Vial set, and a water for injections vial for each Respreeza vial.
Slovenian: Uporabite ločen, neuporabljen komplet Mix2Vial, in vialo z vodo za injekcije za vsako vialo z zdravilom Respreeza.
English: How to store Respreeza 6.
Slovenian: Kako uporabljati zdravilo Respreeza 4.
English: Hyperhidrosis, pruritus
Slovenian: hiperhidroza, pruritus oteklost obraza
English: Some side effects may be serious: Uncommonly (may affect up to 1 in 100 people), allergic reactions have been observed.
Slovenian: Nekateri neželeni učinki so lahko resni: Občasno (pojavijo se lahko pri največ 1 od 100 bolnikov) so opazili alergijske reakcije.
English: 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.
Slovenian: 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.
English: Tell your doctor or healthcare professional immediately if you notice such reactions during the infusion of this medicine.
Slovenian: Zdravniku ali zdravstvenem delavcu takoj povejte, če opazite med infundiranjem tega zdravila take znake.
English: Connect the other end to the injection set (e.g. butterfly / winged infusion needle or infusion catheter).
Slovenian: Drugi konec povežite s pripomočkom za injiciranje (npr. metuljček/infuzijska igla s krilci ali infuzijski kateter).
English: Hypersensitivity reactions (including tachycardia, hypotension, confusion, syncope, oxygen consumption decreased and pharyngeal oedema)
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije (vključno s tahikardijo, hipotenzijo, zmedenostjo, sinkopo, zmanjšano porabo kisika in faringealnim edemom)
English: The infusion solution is normally given over about 15 minutes (about 0.08 ml of solution per kg body weight each min).
Slovenian: Raztopina se običajno infundira 15 minut (približno 0,08ml raztopine na kg telesne mase vsako minuto).
English: 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.
Slovenian: Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) bolečine v bezgavkah (tkivo ovalne oblike, porazdeljeno po vsem telesu, ki je na primer lahko tipno pod pazduho, v dimljah ali vratu), otekel obraz, otekle oči in ustnice.
English: 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.
Slovenian: Emfizem se razvije, ko pomanjkanje zaviralca alfa1-proteinaze povzroči stanje, pri katerem nevtrofilna elastaza ni pod ustreznim nadzorom, kar poškoduje drobne zračne mešičke v pljučih, skozi katere kisik prehaja v telo.
English: At screening, serum alpha1-proteinase inhibitor levels were between 3.2 and 10.1 M (mean of 5.6 M).
Slovenian: Pri presejanju so bile ravni zaviralca alfa1-proteinaze v serumu med 3,2 in 10,1 M (povprečje 5,6 M).
English: 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).
Slovenian: Letna stopnja upada pljučne gostote, izmerjene na sliki CT, pri skupni pljučni kapaciteti (TLC, total lung capacity) v 2-letnem obdobju je bila nižja pri zdravilu Respreeza (-1,45 g/l) v primerjavi s placebom (-2,19 g/l), kar kaže na 34odstotno zmanjšanje (p = 0,017; 1-stransko).
English: 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).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Respreeza za vse podskupine pediatrične populacije s kronično obstruktivno pljučno boleznijo (KOPB) zaradi pomanjkanja zaviralca alfa1-proteinaze (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: It is unknown whether Respreeza passes into human milk.
Slovenian: Ni znano, ali zdravilo Respreeza prehaja v materino mleko.
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.
Slovenian: Počasi odpirajte stišček na pripomočku za apliciranje in pustite zdravilo Respreeza teči, da doseže konec cevk brez zračnih mehurčkov.
English: 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.
Slovenian: Študij razmnoževanja pri živalih z zdravilom Respreeza niso opravili, zato varnost za uporabo med nosečnostjo pri ljudeh ni bila ugotovljena v nadzorovanih kliničnih preskušanjih.
English: This medicine is a white to off-white powder.
Slovenian: To zdravilo je bel do belkast prašek.
English: 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.
Slovenian: Uvedeni ukrepi veljajo za učinkovite proti virusom, kot so virus humane imunske pomanjkljivosti (HIV), virus hepatitisa A, virus hepatitisa B in virus hepatitisa C ter parvovirus B19.
English: minutes (4 g and 5 g presentation).
Slovenian: 4 g in 5 g).
English: Do not use this medicine after the expiry date which is stated on the outer carton and the vial labels after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji škatli in nalepki viale poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: 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.
Slovenian: Devet oseb je prejelo en 60 mg/kg tm odmerek zdravila Respreeza, ki mu je sledilo primerjalno zdravilo, in 9 oseb je prejelo primerjalno zdravilo, ki mu je sledil en 60 mg/kg tm odmerek zdravila Respreeza, z obdobjem izpiranja 35 dni med odmerki.
English: It is strongly recommended that every time you receive a dose of Respreeza the name and batch number of the product are recorded in order to maintain a record of the batches used.
Slovenian: Močno se priporoča, da se po vsaki uporabi odmerka zdravila Respreeza zabeleži ime in številka serije zdravila, da se ohranja evidenca uporabljenih serij.
English: The reconstituted solution should be infused intravenously using a separate dedicated infusion line at an infusion rate of about 0.08 ml / kg bw/ min.
Slovenian: Rekonstituirano raztopino je treba infundirati intravensko s posebno namensko infuzijsko linijo s hitrostjo infundiranja približno 0,08 ml/kg telesne mase/min.
English: In case of self-administration / home-treatment, stop the infusion immediately and contact your doctor or healthcare professional.
Slovenian: Pri samoinfundiranju/zdravljenju doma infuzijo takoj ustavite in se obrnite na zdravnika ali zdravstvenega delavca.
English: Frequency of Adverse Reactions (ARs) in clinical studies and post-marketing experience with Respreeza
Slovenian: Pogostnost neželenih učinkov v kliničnih študijah in iz izkušenj v obdobju trženja zdravila Respreeza
English: The studies investigated the effect of Respreeza on the progression of emphysema, assessed by the decline of lung density, measured by computer tomography (CT).
Slovenian: V študijah so preučevali učinek zdravila Respreeza na napredovanje emfizema, kar je bilo ocenjeno z upadom gostote pljuč, izmerjeno z računalniško tomografijo (CT, computer tomography).
English: 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).
Slovenian: Zdravilo Respreeza je indicirano za vzdrževalno zdravljenje za upočasnitev napredovanja emfizema pri odraslih z dokumentiranim hudim pomanjkanjem zaviralca alfa1-proteinaze (npr. genotipi PiZZ, PiZ(nič), Pi(nič,nič), PiSZ).
English: OUTER BOX
Slovenian: ZUNANJA ŠKATLA
English: After the first infusions, you or your caregiver might also administer Respreeza, but only after receiving adequate training.
Slovenian: Po prvem infundiranju vam lahko zdravilo Respreeza daje negovalec ali si ga dajete sami, vendar le po ustreznem usposabljanju.
English: Suspected allergic or anaphylactic type reactions may require immediate discontinuation of the infusion, depending on the nature and severity of the reaction.
Slovenian: Ob sumu na reakcije alergijske ali anafilaktične vrste bo morda treba z infundiranjem takoj prenehati, odvisno od narave in resnosti reakcije.
English: Do no stop using this medicine without consulting your doctor or healthcare professional.
Slovenian: Če ste prenehali uporabljati zdravilo Respreeza Tega zdravila ne prenehajte uporabljati, ne da bi se posvetovali z zdravnikom ali zdravstvenim delavcem.
English: Gently swirl the Respreeza vial until the powder is completely dissolved (Figure 6).
Slovenian: Nežno obračajte vialo z zdravilom Respreeza dokler se prašek povsem ne raztopi (slika 6).
English: Human alpha1-proteinase inhibitor has a molecular weight of 51 kDa and belongs to the family of serine protease inhibitors.
Slovenian: Humani zaviralec alfa1proteinaze ima molekulno maso 51 kDa in sodi v družino zaviralcev serinske proteaze.
English: • Bend the entire Mix2Vial set to the side until it disconnects from the Respreeza vial (Figure 5).
Slovenian: • Upognite celoten komplet Mix2Vial na stran dokler se ne odstrani iz viale z zdravilom Respreeza (slika 5).
English: Following the completion of the RAPID study, an analysis of achieved median alpha1-proteinase inhibitor levels and lung density decline was conducted.
Slovenian: Po dokončanju študije RAPID so izvedli analizo dosežene mediane ravni zaviralca alfa1-proteinaze in upada pljučne gostote.
English: What Respreeza looks like and contents of the pack
Slovenian: Izgled zdravila Respreeza in vsebina pakiranja
English: A total of 180 subjects with alpha1-proteinase inhibitor deficiency characterized by a serum alpha1-proteinase inhibitor level < 11 μM (i.e. < 50 mg/dL as determined by nephelometry) and clinical evidence of emphysema, were randomized to receive a weekly 60 mg / kg bw intravenous dose of either Respreeza (93 subjects) or placebo (87 subjects) for up to 24 months.
Slovenian: Skupaj 180 oseb s pomanjkanjem zaviralca alfa1-proteinaze, za katerega so značilne ravni zaviralca proteinaze alfa1 v serumu < 11 μM (tj. < 50 mg/dl, kar se določi z nefelometrijo) in kliničnimi znaki emfizema, je bilo randomiziranih za prejemanje tedensko 60 mg/kg telesne mase intravenskega odmerka bodisi zdravila Respreeza (93 oseb) ali placeba (87 oseb) do 24 mesecev.
English: Ensure that the Respreeza vial and water for injections vial are at room temperature (up to 25°C).
Slovenian: Poskrbite, da sta viala z zdravilom Respreeza in viala z vodo za injekcije sobne temperature (do 25 °C).
English: Table 1: Pharmacokinetic parameters for alpha1-proteinase inhibitor following a single 60 mg / kg bw dose of Respreeza Pharmacokinetic Parameter
Slovenian: Preglednica 1: Farmakokinetični parametri za zaviralca alfa1-proteinaze, ki mu sledi en 60 mg/kg telesne mase odmerek zdravila Respreeza Farmakokinetični parametri
English: 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.
Slovenian: Raztopino morate infundirati s hitrostjo infundiranja približno 0,08 ml na kg telesne mase vsako minuto, kot je bilo ugotovljeno glede na vaš odziv in vaše stanje.
English: The subjects ranged in age from 31 to 67 years (median age 54 years) with average baseline alpha1-proteinase inhibitor levels of approximately 6.15 µM, and average volume-adjusted CT lung density of 47 g/L / 50 g/L for Respreeza and placebo subjects, respectively.
Slovenian: Osebe so bile stare od 31 do 67 let (mediana starost 54 let) s povprečnimi izhodiščnimi ravnmi zaviralca alfa1-proteinaze približno 6,15 µM in povprečno za volumen prilagojeno gostoto pljuč na CT 47 g/l za osebe na zdravilu Respreeza in 50 g/l za osebe na placebu.
English: 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.
Slovenian: Uvedeni ukrepi veljajo za učinkovite proti virusom z ovojnico, kot so virus humane imunske pomanjkljivosti (HIV), virus hepatitisa B (HBV) in virus hepatitisa C (HCV) in proti virusom brez ovojnice, kot sta virus hepatitisa A (HAV) in parvovirus B19.
English: Respreeza-treated subjects demonstrated a consistent pattern of slower lung density decline than those receiving placebo (see Figure 1).
Slovenian: Osebe, zdravljene z zdravilom Respreeza, so imele dosledni vzorec počasnejšega upadanja pljučne gostote, kot osebe, ki so prejemale placebo (glejte sliko 1).
English: 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.
Slovenian: Odvisno od narave in resnosti reakcije se lahko zdravnik ali zdravstveni delavec odloči za upočasnitev ali popolno ustavitev infundiranja in dajanje ustreznega zdravljenja za reakcijo.