natgillin/translations-raw huggingface dataset:
In addition, infusion site induration and infusion site pain were common adverse reactions in a bioequivalence study in which 66 subjects were dosed with 115 mg of fosaprepitant intravenously.
V bioekvivalenčni študiji, v kateri je 66 oseb prejelo 115 mg fosaprepitanta intravensko, so pogosto poročali o induraciji in bolečini na mestu injiciranja.
Additional adverse reactions were observed in patients treated with aprepitant (40 mg) for postoperative nausea and vomiting and a greater incidence than with ondansetron: abdominal pain upper, bowel sounds abnormal, dysarthria, dyspnoea, hypoaesthesia, insomnia, miosis, nausea, sensory disturbance, stomach discomfort, visual acuity reduced, wheezing.
Drugi neželeni učinki, ki so bili pri bolnikih, ki so prejemali aprepitant (40 mg) zaradi preprečevanja pooperacijske navzee in bruhanja pogostejši kot pri bolnikih, ki so prejemali ondansetron so: bolečina v zgornjem predelu trebuha, nenormalni črevesni zvoki, disartrija, dispneja, hipestezija, nespečnost, mioza, navzea, senzorične motnje, neugodje v želodcu, zmanjšana ostrina vida in sopeče dihanje.
In addition, two serious adverse reactions were reported in postoperative nausea and vomiting (PONV) clinical studies in patients taking a higher dose of aprepitant: one case of constipation, and one case of sub-ileus.
V kliničnih študijah, v katerih so bolniki zaradi preprečevanja pooperacijske navzee in bruhanja (PONV; “ postoperative nausea and vomiting ”) prejemali večji odmerek aprepitanta, so poročali tudi o enem primeru obstipacije in enem primeru subileusa.
One case of angioedema and urticaria was reported as a serious adverse event in a patient receiving aprepitant in a non-CINV/ non-PONV study.
9 Poročali so o enem primeru angioedema in urtikarije kot o resnem neželenem dogodku, vendar pa ne v študiji preprečevanja s kemoterapijo povzročene navzee in bruhanja ali preprečevanja pooperacijske navzee in bruhanja (CINV/ PONV).
No specific information is available on the treatment of overdose.
O zdravljenju v primeru prevelikega odmerjanja ni posebnih informacij.
Single doses up to 200 mg of fosaprepitant were generally well tolerated in healthy subjects.
Zdrave osebe so enkratne odmerke do 200 mg fosaprepitanta v splošnem dobro prenašale.
Three out of 33 subjects receiving 200 mg of fosaprepitant experienced mild injection site thrombosis.
Pri treh od 33 oseb, ki so prejele 200 mg fosaprepitanta, se je na mestu injiciranja pojavila blaga tromboza.
In the event of overdose, fosaprepitant should be discontinued and general supportive treatment and monitoring should be provided.
V primeru prevelikega odmerjanja je treba dajanje fosaprepitanta prekiniti in uvesti splošne podporne ukrepe ter nadzor.
Because of the antiemetic activity of aprepitant, drug-induced emesis may not be effective.
Zaradi antiemetičnega delovanja aprepitanta, zdravljenje z zdravili za spodbujanje bruhanja verjetno ne bo učinkovito.
Antiemetics and antinauseants, ATC code:
Antiemetiki in zdravila proti slabosti, oznaka ATC:
Fosaprepitant is the prodrug of aprepitant and when administered intravenously is converted rapidly to aprepitant (see section 5.2).
Fosaprepitant je predzdravilo, ki se po intravenski aplikaciji hitro pretvori v aprepitant (glejte poglavje 5. 2).
The contribution of fosaprepitant to the overall antiemetic effect has not fully been characterized, but a transient contribution during the initial phase cannot be ruled out.
Prispevek fosaprepitanta k skupnemu antiemetičnemu delovanju ni povsem pojasnjen, vendar pa prehodnega učinka med uvodno fazo ni možno izključiti.
In 2 randomised, double-blind studies encompassing a total of 1,094 patients receiving chemotherapy that included cisplatin ≥ 70 mg/ m2, aprepitant in combination with an ondansetron/ dexamethasone regimen (see section 4.2) was compared with a standard regimen (placebo plus ondansetron 32 mg intravenously administered on Day 1 plus dexamethasone 20 mg orally on Day 1 and 8 mg orally twice daily on Days 2 to 4).
V dveh randomiziranih, dvojno slepih študijah, ki sta skupaj zajeli 1. 094 bolnikov na kemoterapiji, ki je vključevala cisplatin ≥ 70 mg/ m2, so aprepitant v kombinaciji z ondansetronom/ deksametazonom (glejte poglavje 4. 2) primerjali s standardno obliko zdravljenja (placebo in ondansetron v odmerku 32 mg intravensko prvi dan ter deksametazon v odmerku 20 mg peroralno prvi dan in 8 mg peroralno dvakrat na dan od drugega do četrtega dne).
10 A summary of the key study results from the combined analysis is shown in Table 1.
Povzetek ključnih rezultatov kombinirane analize je prikazan v Preglednici 1.
Table 1 Percent of Patients Receiving Highly Emetogenic Chemotherapy Responding by Treatment Group and Phase — Cycle 1
10 Preglednica 1 Odstotek bolnikov, ki so prejemali zelo emetogeno kemoterapijo, z odzivom po zdravljenih skupinah in fazi – 1. ciklus
Aprepitant Regimen
Aprepitant
Standard Therapy
Običajno
Differences*
Razlike *
521 )†%
(n = 521) †%
(N= 524 )†%%
zdravljenje (n = 524) †
Complete Response (no emesis and no rescue therapy)
Popoln odziv (brez bruhanja in brez rešilnega zdravljenja)
Overall (0-120 hours) 0-24 hours 25-120 hours
Skupaj (0 - 120 ur) 0 - 24 ur 25 - 120 ur
Overall (0-120 hours) 25-120 hours
Skupaj (0 - 120 ur) 25 - 120 ur
* The confidence intervals were calculated with no adjustment for gender and concomitant chemotherapy, which were included in the primary analysis of odds ratios and logistic models. † One patient in the Aprepitant Regimen only had data in the acute phase and was excluded from the overall and delayed phase analyses; one patient in the Standard Regimen only had data in the delayed phase and was excluded from the overall and acute phase analyses.
Pri enem bolniku, ki se je zdravil s standardno obliko zdravljenja, so na voljo le podatki iz zapoznele faze, in je tako izključen iz skupne analize in analize akutne faze.
The estimated time to first emesis in the combined analysis is depicted by the Kaplan-Meier plot in Figure 1.
Oceno časa do prvega bruhanja v kombinirani analizi prikazuje Kaplan- Meierjeva krivulja na Sliki 1.
Figure 1 Percent of Patients Receiving Highly Emetogenic Chemotherapy Who Remain Emesis Free Over Time – Cycle 1
Slika 1 Odstotek bolnikov, ki so prejemali zelo emetogeno kemoterapijo, pri katerih se bruhanje ne pojavi, glede na čas – 1. ciklus
11 In the same 2 clinical studies, 851 patients continued into the Multiple-Cycle extension for up to 5 additional cycles of chemotherapy.
851 bolnikov iz teh dveh študij je zdravljenje nadaljevalo v podaljšku z več ciklusi, in sicer so prejeli do 5 dodatnih ciklusov kemoterapije.
The efficacy of the aprepitant regimen was maintained during all cycles.
Učinkovitost aprepitanta se je očitno ohranjala v vseh ciklusih.
In a randomised, double-blind study in a total of 866 patients (864 females, 2 males) receiving chemotherapy that included cyclophosphamide 750-1500 mg/ m2; or cyclophosphamide 500-1500 mg/ m2 and doxorubicin (≤ 60 mg/ m2) or epirubicin (≤ 100 mg/ m2), aprepitant in combination with an ondansetron/ dexamethasone regimen (see section 4.2) was compared with standard therapy (placebo plus ondansetron 8 mg orally (twice on Day 1, and every 12 hours on Days 2 and 3) plus dexamethasone 20 mg orally on Day 1).
11 V randomizirani, dvojno slepi študiji, ki je skupaj zajela 866 bolnikov (864 žensk, 2 moška), ki so dobivali kemoterapijo s ciklofosfamidom v odmerku od 750 do 1. 500 mg/ m2 ali ciklofosfamidom v odmerku od 500 do 1. 500 mg/ m2 in doksorubicinom (≤ 60 mg/ m2) ali epirubicinom (≤ 100 mg/ m2), so primerjali aprepitant v kombinaciji z ondansetronom in deksametazonom (glejte poglavje 4. 2) ter standardno obliko zdravljenja (placebo in ondansetron v odmerku 8 mg peroralno (dvakrat 1. dan ter na 12 ur 2. in 3. dan) ter deksametazon 20 mg peroralno 1. dan).
433 )†%
(n = 433) †
(N= 424)%%
(n = 424)%%
Overall (0-120 hours) 0-24 hours 25-120 hours
Skupaj (0– 120 ur) 0– 24 ur
Overall (0-120 hours) 0-24 hours 25-120 hours
25– 120 ur
75.7 87.5 80.8
55, 4
58.7 77.3 69.1
49, 1
17.0 10.2 11.7
6, 3
(10.8, 23.2) (5.1, 15.3) (5.9, 17.5)
(- 0, 4; 13, 0)
No Significant Nausea (maximum VAS < 25 mm on a scale of 0-100 mm)
POSAMEZNI MERILI Brez bruhanja (brez bruhanja ne glede na rešilno zdravljenje)
60.9 79.5 65.3
75, 7 87, 5 80, 8
55.7 78.3 61.5
58, 7 77, 3 69, 1
5.3 1.3 3.9
17, 0 10, 2 11, 7
(-1.3, 11.9) (-4.2, 6.8) (-2.6, 10.3)
(10, 8; 23, 2) (5, 1; 15, 3) (5, 9; 17, 5)
Aprepitant Regimen (N=432) Standard Therapy (N=424) 90%
Brez pomembne navzee (največja ocena < 25 mm na vizualni analogni lestvici 0 – 100 mm)
120
Skupaj (0– 120 ur) 0– 24 ur 25– 120 ur
Time (hours)
(- 1, 3; 11, 9) (- 4, 2; 6, 8) (- 2, 6; 10, 3)
In the same clinical study, 744 patients continued into the Multiple-Cycle extension for up to 3 additional cycles of chemotherapy.
12 Slika 2 Odstotek bolnikov, ki so prejemali zmerno emetogeno kemoterapijo, pri katerih se bruhanje ne pojavi, glede na čas – 1. ciklus
The efficacy of the aprepitant regimen was maintained during all cycles.
V isti klinični študiji je 744 bolnikov nadaljevalo v podaljšku z več ciklusi, in sicer so prejeli do 3 dodatne cikluse kemoterapije.
Aprepitant after fosaprepitant administration The AUC of aprepitant following 115 mg of fosaprepitant was equivalent to the AUC of 125 mg of oral aprepitant, while Cmax was 2.5-fold higher.
Aprepitant po aplikaciji fosaprepitanta Vrednost AUC aprepitanta je po uporabi fosaprepitanta v odmerku 115 mg enaka vrednosti AUC po uporabi peroralnega aprepitanta v odmerku 125 mg, vrednost Cmax pa je 2, 5- krat večja.
Following a single intravenous dose of fosaprepitant administered as a 15-minute infusion to healthy volunteers the mean AUC0-24hr of aprepitant was 19.8 μ g• hr/ ml and the mean maximal aprepitant concentration was 3.26 μ g/ ml.
Po enkratnem intravenskem odmerku fosaprepitanta v obliki 15- minutne intravenske infuzije je bila pri zdravih prostovoljcih srednja vrednost AUC0- 24ur aprepitanta 19, 8 μg• h/ ml, srednja največja koncentracija aprepitanta pa 3, 26 μg/ ml.
The mean aprepitant plasma concentrations from 4 hours after dosing (including the concentration at 24 hours postdose) were similar between the 125 mg oral aprepitant dose and the 115 mg intravenous fosaprepitant dose.
Srednje plazemske koncentracije od 4 ure po odmerku (vključno s koncentracijami 24 ur po odmerku) so bile pri uporabi peroralnega aprepitanta v odmerku 125 mg in fosaprepitanta intravensko v odmerku 115 mg podobne.
Distribution Aprepitant is highly protein bound, with a mean of 97%.
Porazdelitev Aprepitant se močno veže na beljakovine, povprečno 97 odstotno.
The geometric mean apparent volume of distribution at steady state (Vdss) is approximately 66 l in humans.
Geometrični srednji navidezni volumen porazdelitve v stanju dinamičnega ravnovesja (Vdss) je pri človeku približno 66 litrov.
Metabolism Fosaprepitant was rapidly converted to aprepitant in in vitro incubations with liver preparations from humans.
Presnova Pri in vitro inkubaciji s humanimi jetrnimi celicami se je fosaprepitant hitro pretvoril v aprepitant.
Furthermore, fosaprepitant underwent rapid and nearly complete conversion to aprepitant in S9 preparations from other human tissues including kidney, lung and ileum.
Pretvorba fosaprepitanta v aprepitant je bila hitra in skoraj popolna tudi pri frakcijah S9, pridobljenih iz drugih človeških tkiv, vključno z ledvicami, pljuči in ileumom, kar kaže, da pretvorba fosaprepitanta v aprepitant lahko poteka v različnih tkivih.
Thus, it appears that the conversion of fosaprepitant to aprepitant can occur in multiple tissues.
Pri človeku se fosaprepitant hitro pretvori v aprepitant, v 30 minutah po koncu infundiranja.
In humans, fosaprepitant administered intravenously was rapidly converted to aprepitant within 30 minutes following the end of infusion.
Presnova aprepitanta poteka večinoma z oksidacijo na
13 Aprepitant undergoes extensive metabolism.
13 morfolinskem obroču in na njegovih stranskih verigah; aktivnost tako nastalih presnovkov je šibka.
All metabolites observed in urine, faeces and plasma following an intravenous 100 mg [14C]-fosaprepitant dose were also observed following an oral dose of [14C]-aprepitant.
Vsi presnovki, opaženi v urinu, blatu in plazmi po intravenskem 100 mg [14C] odmerku fosaprepitanta so bili opaženi tudi po peroralnem odmerku [14C] - aprepitanta.
Upon conversion of 115 mg of fosaprepitant to aprepitant, 18.3 mg of phosphate is liberated from fosaprepitant.
Pri pretvorbi 115 mg fosaprepitanta v aprepitant se iz fosaprepitanta sprosti 18, 3 mg fosfata.
Elimination Aprepitant is not excreted unchanged in urine.
Izločanje Aprepitant se ne izloča z urinom v nespremenjeni obliki.
Following a single intravenously administered 100 mg dose of [14C]- fosaprepitant to healthy subjects, 57% of the radioactivity was recovered in urine and 45% in faeces.
Pri zdravih preiskovancih se je po enem intravenskem odmerku 100 mg predzdravila [14C] aprepitanta 57% radioaktivnosti izločilo v urinu, 45% pa v blatu.
The terminal half-life of aprepitant after oral administration ranged from approximately 9 to 13 hours.
Končni razpolovni čas aprepitanta po peroralni uporabi se giblje približno med 9 in 13 urami.
Pharmacokinetics in special populations Fosaprepitant pharmacokinetics has not been evaluated in special populations.
Farmakokinetika pri posebnih skupinah bolnikov Pri posebnih skupinah bolnikov farmakokinetike fosaprepitanta niso proučevali.
Fosaprepitant has not been evaluated in patients below 18 years of age.
Pri bolnikih, mlajših od 18 let, fosaprepitanta niso preučevali.
Fosaprepitant is metabolized in various extrahepatic tissues; therefore hepatic insufficiency is not expected to alter the conversion of fosaprepitant to aprepitant.
Fosaprepitant se presnavlja v številnih ekstrahepatičnih tkivih, zato ne pričakujemo, da bi insuficienca jeter vplivala na pretvorbo fosaprepitanta v aprepitant.
Mild hepatic insufficiency (Child-Pugh score 5 to 6) does not affect the pharmacokinetics of aprepitant to a clinically relevant extent.
Blaga insuficienca jeter (5 do 6 točk po Child- Pugh- ovi klasifikaciji) na farmakokinetiko aprepitanta ne vpliva v tolikšni meri, da bi bilo to klinično pomembno.
No dose adjustment is necessary for patients with mild hepatic insufficiency.
Pri bolnikih z blago insuficienco jeter odmerka ni treba prilagajati.
Conclusions regarding the influence of moderate hepatic insufficiency (Child-Pugh score 7 to 8) on aprepitant pharmacokinetics cannot be drawn from available data.
Iz razpoložljivih podatkov ni mogoče sklepati, kakšen je vpliv zmerne insuficience jeter (7 do 8 točk po Child- Pugh- ovi klasifikaciji) na farmakokinetiko aprepitanta.
There are no clinical or pharmacokinetic data in patients with severe hepatic insufficiency (Child-Pugh score > 9).
Klinični podatki o farmakokinetiki aprepitanta pri bolnikih s hudo insuficienco jeter (> 9 točk po Child- Pugh- ovi klasifikaciji) niso na voljo.
A single 240 mg dose of oral aprepitant was administered to patients with severe renal insufficiency (CrCl < 30 ml/ min) and to patients with end stage renal disease (ESRD) requiring haemodialysis.
Bolnikom s hudo insuficienco ledvic (očistek kreatinina < 30 ml/ min) ter bolnikom z odpovedjo ledvic v končnem stadiju, ki se zdravijo s hemodializo, so dali en sam odmerek 240 mg peroralnega aprepitanta.
In patients with severe renal insufficiency, the AUC0-∞ of total aprepitant (unbound and protein bound) decreased by 21% and Cmax decreased by 32%, relative to healthy subjects.
Pri bolnikih s hudo insuficienco ledvic je bil AUC0– ∞ celokupnega aprepitanta (nevezanega in vezanega na beljakovine) za 21% manjši, Cmax pa za 32% nižja kot pri zdravih preiskovancih.
In patients with ESRD undergoing haemodialysis, the AUC0-∞ of total aprepitant decreased by 42% and Cmax decreased by 32%.
Pri bolnikih z odpovedjo ledvic v končnem stadiju, ki se zdravijo s hemodializo, je bil AUC0– ∞ celokupnega aprepitanta za 42% manjši, Cmax pa za 32% nižja.
Due to modest decreases in protein binding of aprepitant in patients with renal disease, the AUC of pharmacologically active unbound aprepitant was not significantly affected in patients with renal insufficiency compared with healthy subjects.
Zaradi nekoliko manjše vezave aprepitanta na beljakovine pri bolnikih z insuficienco ledvic, se AUC farmakološko aktivnega nevezanega zdravila v primerjavi z zdravimi preiskovanci ni bistveno spremenil.
Haemodialysis conducted 4 or 48 hours after dosing had no significant effect on the pharmacokinetics of aprepitant; less than 0.2% of the dose was recovered in the dialysate.
Hemodializa, izvedena 4 ali 48 ur po odmerjanju, ni pomembno vplivala na farmakokinetiko aprepitanta; v dializatu se je izločilo manj kot 0, 2% odmerka.
No dose adjustment is necessary for patients with renal insufficiency or for patients with ESRD undergoing haemodialysis.
Pri bolnikih z okvaro ledvic in bolnikih z odpovedjo ledvic v končnem stadiju, ki se zdravijo s hemodializo, odmerka ni treba prilagajati.
Relationship between concentration and effect Fosaprepitant is a prodrug of aprepitant.
Povezava med koncentracijo in učinkom Fosaprepitant je predzdravilo aprepitanta.
PET imaging studies, using a highly specific NK1-receptor tracer, in healthy young men after administration of oral aprepitant have shown that aprepitant penetrates into the brain and occupies NK1 receptors in a dose-and plasma-concentration-dependent manner.
Pri študijah s pozitronsko emisijsko tomografijo (PET) so pri zdravih mladih odraslih moških z uporabo visoko specifičnega označevalca receptorjev NK1 ugotovili, da aprepitant po peroralni uporabi prodre v možgane in zasede receptorje NK1, pri čemer je stopnja zasedenosti odvisna od odmerka in plazemske koncentracije.
Aprepitant plasma concentrations achieved with the 3-day regimen of oral aprepitant are predicted to provide greater than 95% occupancy of brain NK1 receptors.
Predvidevajo, da plazemske koncentracije aprepitanta, ki jih dosežemo s 3 dni trajajočim zdravljenjem s peroralnim aprepitantom, zagotavljajo več kot 95- odstotno zasedenost možganskih receptorjev NK1.
The relationship between concentration and effect has not been evaluated after administration of fosaprepitant.
Pri uporabi fosaprepitanta povezave med koncentracijo in učinkom niso vrednotili.
Pre-clinical data obtained with intravenous administration of fosaprepitant and oral administration of aprepitant reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity, genotoxicity (including in vitro tests), and toxicity to reproduction.
5. 3 Predklinični podatki o varnosti 14 Predklinični podatki, pridobljeni pri intravenski uporabi fosaprepitanta in peroralni uporabi aprepitanta, na osnovi običajnih študij toksičnosti pri enkratnem odmerku in ponavljajočih se odmerkih, genotoksičnosti (vključno z in vitro testi) in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
In laboratory animals, fosaprepitant in non-commercial formulations caused vascular toxicity and hemolysis at concentrations below 1 mg/ ml and higher, dependent on the formulation.
Pri laboratorijskih živalih je bila uporaba nekomercialnih oblik fosaprepitanta povezana z vaskularno toksičnostjo in hemolizo pri koncentracijah, manjših od 1 mg/ ml ali večjih, odvisno od oblike.
In human washed blood cells also evidence of hemolysis was found with non-commercial formulations at fosaprepitant concentrations of 2.3 mg/ ml and higher, although tests in human whole blood were negative.
Izprane humane krvne celice so pri preskusih nekomercialnih oblik fosaprepitanta pri koncentracijah fosaprepitanta 2, 3 mg/ ml in večjih kazale znake hemolize, preiskave polne krvi pa so bile negativne.
No hemolysis was found with the commercial formulation up to a fosaprepitant concentration of 1 mg/ ml in human whole blood and washed human erythrocytes.
Pri uporabi komercialnih farmacevtskih oblik fosaprepitanta v koncentraciji do 1 mg/ ml hemolize v polni človeški krvi ali pri izpranih eritrocitih niso opazili.
In the performed safety pharmacology and repeated dose toxicity studies with dogs, fosaprepitant Cmax and aprepitant AUC values were 4-7 times and 60-70 times, respectively, higher than clinical values.
V izvedenih študijah farmakološke varnosti in toksičnosti pri ponavljajočih se odmerkih na psih, je bila vrednost Cmax fosaprepitanta 4 do 7- krat večja od klinične vrednosti, vrednost AUC aprepitanta pa za 60 do 70- krat večja od klinične vrednosti.
Disodium edetate (E386) Polysorbate 80 (E433) Lactose anhydrous Sodium hydroxide (E524) (for pH adjustment) and/ or Hydrochloric acid diluted (E507) (for pH adjustment)
dinatrijev edetat (E386) polisorbat 80 (E433) brezvodna laktoza natrijev hidroksid (E524) (za uravnavo pH) in/ ali razredčena klorovodikova kislina (E507) (za uravnavo pH)
IVEMEND is incompatible with any solutions containing divalent cations (e. g., Ca2+, Mg2+), including Hartman’ s and Lactated Ringer’ s Solutions.
Ca2+, Mg2+), vključno s Hartmanovo raztopino in raztopino Ringerjevega laktata.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6..
Zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6. 6.
From a microbiological point of view, the product should be used immediately.
Če se raztopine ne uporabi takoj po pripravi, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik.
For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Za pogoje shranjevanja rekonstituiranega in razredčenega zdravila glejte poglavje 6. 3.
15 10 ml Type I clear glass vial with a chlorobutyl or bromobutyl rubber stopper and an aluminum seal with a blue plastic flip off cap.
10- ml viala iz prozornega stekla tipa I z zamaškom iz klorobutilne ali bromobutilne gume, zaprta z aluminijastim obročkom in modro dvižno zaporko.
IVEMEND will be available as a pack of 1 vial of 115 mg fosaprepitant or 10 vials of 115 mg fosaprepitant.
15 Pakiranje zdravila IVEMEND vsebuje 1 vialo s 115 mg fosaprepitanta ali 10 vial s 115 mg fosaprepitanta.
IVEMEND must be reconstituted and then diluted prior to administration.
Pred aplikacijo morate zdravilo IVEMEND pripraviti in razredčiti.
Preparation for intravenous administration:
Priprava za intravensko aplikacijo:
Inject 5 ml sodium chloride 9 mg/ ml (0.9%) solution for injection into the vial.
V vialo dodajte 5 ml 0, 9- odstotne (9 mg/ ml) raztopine natrijevega klorida za injiciranje.
Assure that sodium chloride 9 mg/ ml (0.9%) solution for injection is added to the vial along the vial wall in order to prevent foaming.
Za preprečitev penjenja morate 0, 9- odstotno (9 mg/ ml) raztopino natrijevega klorida za injiciranje dodajati po steni viale.
Avoid shaking and jetting sodium chloride 9 mg/ ml (0.9%) solution for injection into the vial.
Viale ne smete tresti in 0, 9- odstotne (9 mg/ ml) raztopine natrijevega klorida za injiciranje ne smete brizgniti v vialo.
Prepare an infusion bag filled with 110 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection (for example, by adding 10 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection to a 100 ml sodium chloride 9 mg/ ml (0.9%) solution for injection infusion bag).
Pripravite infuzijsko vrečko s 110 ml 0, 9- odstotne (9 mg/ ml) raztopine natrijevega klorida za injiciranje (na primer, infuzijski vrečki s 100 ml 0, 9- odstotne (9 mg/ ml) raztopine natrijevega klorida za injiciranje dodajte 10 ml 0, 9- odstotne (9 mg/ ml) raztopine natrijevega klorida za injiciranje).
Withdraw the entire volume from the vial and transfer it into an infusion bag containing 110 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection to yield a total volume of 115 ml.
Iz viale izvlecite celoten volumen raztopine in jo dodajte v infuzijsko vrečko s 110 ml 0, 9 - odstotne (9 mg/ ml) raztopine natrijevega klorida za injiciranje, da dobite skupni volumen 115 ml.
Gently invert the bag 2-3 times.
Vrečko 2 do 3- krat nežno obrnite.
The medicinal product must not be reconstituted or mixed with solutions for which physical and chemical compatibility has not been established (see section 6.2).
Zdravila ne smete pripravljati ali mešati z raztopinami za katere ni bila dokazana fizikalna in kemična kompatibilnost (glejte poglavje 6. 2).