natgillin/translations-raw huggingface dataset:
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. žilah do srca.
This helps to obtain a better contrast between the area where the gas bubbles are (such as the heart chambers) and the surrounding tissue during the echocardiography.
S tem med ehokardiografijo dobimo boljši kontrast med področjem, kjer so mehurčki plina (npr. v srčnih votlinah), in okoliškim tkivom.
The effects of Luminity were first tested in experimental models before being studied in humans.
Učinki sredstva Luminity so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
There were five main studies of the effectiveness of Luminity, involving a total of 401 patients.
Opravljenih je bilo pet glavnih študij o učinkovitosti zdravila Luminity, v katerih je skupaj sodeloval 401 bolnik.
Three studies looked at its effectiveness in enhancing the image of the left ventricle, comparing the echocardiography scan before and after administration of Luminity.
Tri študije so preučevale učinkovitost zdravila pri ojačevanju slike levega prekata, in sicer s primerjanjem ehokardiografskih posnetkov pred uporabo zdravila Luminity in po njem.
In two of these studies, Luminity was compared with placebo (a dummy treatment).
V dveh študijah pa je bilo zdravilo Luminity primerjano s placebom (zdravilom brez zdravilne učinkovine).
The last two studies were set up primarily to look at the effectiveness of Luminity in improving the accuracy of the measurement of the ejection fraction (the percentage of the blood volume that is pumped out of the heart in one beat).
Namen zadnjih dveh študij je bil predvsem preučiti učinkovitost zdravila Luminity pri izboljševanju natančnosti meritev iztisnega deleža (odstotek volumna krvi, ki ga srce iztisne ob enem utripu).
These studies also looked at left ventricle image enhancement.
V teh študijah pa so preučevali tudi ojačevanje slike levega prekata.
As all five original studies were carried out with a technique known as ‘ fundamental’ ultrasound imaging, the company also presented the results of some studies to show that the results seen using fundamental imaging could also be obtained when using the imaging techniques known as ‘ harmonic’ and ‘ non-linear’.
Ker je bilo vseh pet prvotnih študij opravljenih s tehniko, znano kot „ osnovni “ način ultrazvočnega slikanja, je družba predstavila tudi rezultate nekaterih študij, da bi dokazala, da je rezultate, vidne z osnovnim ultrazvočnim slikanjem, možno dobiti tudi z uporabo tehnik, znanih kot „ harmonične “ in „ nelinearne “ metode.
The most common side effects with Luminity (seen in between 1 and 10 patients in 100) are headache and flushing (reddening of the skin).
Najpogostejša neželena učinka zdravila Luminity (opažena pri 1 do 10 bolnikih izmed 100) sta glavobol in zardevanje (pordečitev kože).
For the full list of all side effects reported with Luminity, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Luminity, glejte navodilo za uporabo.
Luminity should not be used in people who may be hypersensitive (allergic) to perflutren or any of the other ingredients.
Zdravila Luminity ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) perflutren ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that Luminity’ s benefits are greater than its risks for use as an ultrasound contrast-enhancing agent in echocardiography.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Luminity za uporabo kot ultrazvočno kontrastno sredstvo pri ehokardiografiji večje od z njim povezanih tveganj.
The Committee recommended that Luminity be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Luminity odobri dovoljenje za promet.
Other information about Luminity:
Druge informacije o zdravilu Luminity:
The European Commission granted a marketing authorisation valid throughout the European Union for Luminity to Bristol-Myers Squibb Pharma Belgium Sprl on 20 September 2006.
Evropska komisija je dovoljenje za promet z zdravilom Luminity, veljavno po vsej Evropski uniji, odobrila družbi Bristol- Myers Squibb Pharma Belgium Sprl dne 20. septembra 2006.
The full EPAR for Luminity can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Luminity je na voljo tukaj.
EMEA Number
Številka postopka EMEA
150 microl itres/ ml
150 mikrolitrov / ml
Luminity 150 microlitres/ ml solution for dispersion for injection or infusion
Luminity 150 mikrolitrov/ ml raztopina za disperzijo za injiciranje ali infundiranje
Each ml contains a maximum of 6.4 x 109 perflutren-containing lipid microspheres, with a mean diameter range of 1.1-2.5 micrometres (μ m).
En mililiter vsebuje največ 6, 4 x 109 lipidnih mikrosfer, ki vsebujejo perflutren; povprečni razpon premera mikrosfer je od 1, 1 do 2, 5 mikrometra (μm).
The approximate amount of perflutren gas in each ml is 150 microlitres (μ l).
Približna količina plina perflutrena je 150 mikrolitrov (μl) na mililiter.
Excipient:
Pomožna snov: natrij 2, 679 mg na ml.
Sodium 2.679 mg per ml
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Solution for dispersion for injection or infusion
Raztopina za disperzijo za injiciranje ali infundiranje.
Colourless, uniformly clear to translucent liquid.
Brezbarvna, enakomerno bistra do prosojna tekočina.
Luminity is an ultrasound contrast-enhancing agent for use in patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.
Zdravilo Luminity je ultrazvočno kontrastno sredstvo, ki ga uporabljamo pri bolnikih s potrjeno ishemično boleznijo srca ali sumom nanjo, pri katerih je bila ehokardiografija suboptimalna (pri projekciji “ štirih ” ali “ dveh votlin ” vsaj dveh od šestih segmentov prekatne stene ni bilo možno ovrednotiti), da bi tako dosegli opacifikacijo srčnih votlin in boljšo zamejitev endokardialne meje levega prekata tako v mirovanju kot med obremenitvijo.
Luminity should only be administered by trained physicians with technical expertise in performing and interpreting contrast echocardiograms, and appropriate resuscitation equipment should be available in case of hypersensitivity reactions.
Zaradi možnega pojava preobčutljivostnih reakcij je pri uporabi zdravila Luminity treba imeti na voljo ustrezno opremo za oživljanje.
Before administering Luminity, the product must be activated by using a mechanical shaking device, the Vialmix (see section 6.6).
Pred apliciranjem je treba zdravilo Luminity aktivirati z Vialmixom, mehanično napravo za stresanje (glejte poglavje 6. 6).
This product should only be administered intravenously.
Zdravilo se sme dajati izključno intravensko.
The recommended dose is multiple injections of 0.1 to 0.4 ml, followed by a 3 to 5 ml bolus of sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection to maintain optimal contrast enhancement.
Priporočeni odmerek je več injekcij od 0, 1 do 0, 4 ml, ki jim sledi bolus od 3 do 5 ml 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje ali 50 mg/ ml (5%) raztopine glukoze za injiciranje za ohranitev optimalne ojačitve kontrasta.
The total dose should not exceed 1.6 ml.
Celotni odmerek ne sme preseči 1, 6 ml.
The recommended dose is 10 microlitre dispersion/ kg by slow bolus intravenous injection, followed by a 10 ml bolus of sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection.
2 Priporočeni odmerek je 10 mikrolitrov disperzije/ kg v počasni bolusni intravenski injekciji, ki ji sledi 10- ml bolus 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje ali 50 mg/ ml (5%) raztopine glukoze za injiciranje.
2 If necessary, a second 10 microlitre dispersion/ kg dose followed by a second 10 ml bolus of sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection may be administered 5 minutes after the first injection to prolong contrast enhancement.
Če je potrebno, lahko za podaljšanje ojačitve kontrasta 5 minut po prvi injekciji aplicirate drugi odmerek 10 mikrolitrov disperzije/ kg, ki mu sledi drugi 10- ml bolus 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje ali 50 mg/ ml (5%) raztopine glukoze za injiciranje.
The recommended dose is via an intravenous infusion of 1.3 ml added to 50 ml of sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection.
Priporočeni odmerek je intravenska infuzija 1, 3 ml zdravila, dodanega 50 ml 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje ali 50 mg/ ml (5%) raztopine glukoze za injiciranje.
The rate of infusion should be initiated at 4.0 ml/ minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 ml/ minute.
Potem jo prilagodite, kot je potrebno za optimalno ojačitev slike, ne sme pa preseči 10 ml/ minuto.
Luminity should not be used with fundamental imaging technique for stress echocardiography since efficacy and safety have not been established.
Zdravila Luminity se ne sme uporabljati pri osnovnih načinih slikanja med obremenitveno ehokardiografijo, saj učinkovitost in varnost nista bila dokazana.
Luminity should not be used in patients below 18 years as efficacy and safety in these groups have not been established.
Zdravila Luminity ne smete uporabljati pri bolnikih, mlajših od 18 let, saj učinkovitost in varnost v tej skupini nista bila dokazana.
Elderly Patients:
Starostniki:
Hypersensitivity to perflutren or to any of the excipients.
Preobčutljivost za perflutren ali katerokoli pomožno snov.
The safety of Luminity in patients with right-to-left, bi-directional or transient right-to-left cardiac shunts has not been studied.
Varnost zdravila Luminity ni raziskana pri bolnikih z desno- levimi, dvosmernimi ali prehodnimi desno- levimi srčnimi spoji (šanti).
Caution must be exercised when considering the administration of Luminity to these patients (see section 5.3).
Zato se morate za uporabo zdravila Luminity pri takšnih bolnikih odločiti previdno (glejte poglavje 5. 3).
Other methods of administration not specified in section 4.2 (e. g. intra-arterial injection) are not recommended.
Drugi načini apliciranja, ki niso navedeni v poglavju 4. 2 (npr. intraarterijsko injiciranje), niso priporočljivi.
If Luminity is administered directly to the patient without undergoing the mechanical activation procedure using the Vialmix (see section 6.6), the product will not produce its intended effect.
Če zdravilo Luminity aplicirate, ne da bi ga pred tem mehanično aktivirali z Vialmixom (glejte poglavje 6. 6), ne bo imel želenega učinka.
As experience is limited in patients with certain severe states of cardiac and pulmonary diseases, Luminity should be used only after careful consideration and such use should be monitored closely during administration.
Izkušnje pri bolnikih z nekaterimi hudimi stanji bolezni srca in pljuč so omejene, zato je treba zdravilo Luminity pri njih uporabljati po tehtnem premisleku, bolnike pa med dajanjem skrbno nadzirati.
These states include adult respiratory distress syndrome, severe heart failure (NYHA IV), endocarditis, acute myocardial infarction with on-going angina or unstable angina, hearts with prosthetic valves, acute states of systemic inflammation or sepsis, known states of hyperactive coagulation system and/ or recurrent thromboembolism.
Ta stanja vključujejo akutni respiratorni distres sindrom, hudo srčno popuščanje (NYHA IV), endokarditis, akutni miokardni infarkt, povezan z angino pektoris ali nestabilna angina pektoris, umetne srčne zaklopke, akutna stanja sistemskih okužb ali sepsa, znana stanja hiperaktivnosti sistema koagulacije in/ ali ponavljajoča se trombembolija.
3 Serious immediate hypersensitivity reactions (eg: anaphylaxis, anaphylactic shock and anaphylactoid reactions, hypotension and angioedema) have been reported following the administration of Luminity.
3 Po aplikaciji zdravila Luminity so poročali o pojavu resnih takojšnjih preobčutljivostnih reakcij (npr. anafilaksija, anafilaktični šok in anafilaktoidne reakcije, hipotenzija ter angioedem).
Patients should be closely monitored and administration should be under the direction of a physician experienced in the management of hypersensitivity reactions including severe allergic reactions, which might require resuscitation.
Zdravilo se sme uporabljati le pod neposrednim nadzorom zdravnika, ki ima izkušnje z ukrepanjem v primeru pojava preobčutljivostnih reakcij, vključno s hudimi alergijskimi reakcijami, pri katerih je lahko potrebno oživljanje.
Emergency equipment and personnel trained in its use must be readily available.
Oprema za nujne primere in osebje, usposobljeno za njeno uporabo, mora biti vedno na voljo.
The reported adverse reactions following the use of Luminity in pivotal and supportive trials (total of 2,526 patients) have generally been mild to moderate in intensity, occur within minutes after administration and usually resolve without therapeutic intervention within 15 minutes.
Neželeni učinki po uporabi zdravila Luminity v ključnih in podpornih preskušanjih (pri skupno 2. 526 bolnikih) so bili praviloma blagi do zmerni; pojavili so se v nekaj minutah po aplikaciji in so ponavadi v 15 minutah minili brez terapevtskega ukrepanja.
The most frequently reported adverse reactions are: headache (2.0%), flushing (1.0%) and back pain (0.9%).
Najpogosteje opisani neželeni učinki so glavobol (2, 0%), zardevanje (1, 0%) in bolečine v hrbtu (0, 9%).
In clinical trials with Luminity, adverse reactions were reported with the following frequencies (Very common ≥ 1/ 10; Common ≥ 1/ 100, < 1/ 10; Uncommon ≥ 1/ 1,000, < 1/ 100; Rare ≥ 1/ 10,000, < 1/ 1,000; Very rare < 1/ 10,000).
V kliničnih preskušanjih zdravila Luminity so zabeležili naslednjo pogostnost neželenih učinkov (zelo pogosti ≥ 1/ 10; pogosti ≥ 1/ 100, < 1/ 10; občasni ≥ 1/ 1. 000, < 1/ 100; redki ≥ 1/ 10. 000, < 1/ 1. 000; zelo redki < 1/ 10. 000).
Investigations Cardiac disorders Nervous system disorders
4 Preiskave Srčne bolezni Bolezni živčevja
Paraesthesia
redki: nenormalen elektrokardiogram redki: bradikardija, tahikardija, palpitacije pogosti: glavobol občasni: omotica, motnje okušanja redki: parestezije
Respiratory Distress, Cough, Dry Throat Uncommon:
občasni: dispneja, draženje žrela redki: dihalna stiska, kašelj, suho žrelo občasni: bolečine v trebuhu, driska, navzea, bruhanje redki: dispepsija
Abdominal Pain, Diarrhoea, Nausea, Vomiting Rare:
Bolezni kože in podkožja
Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders Vascular disorders
občasni: srbenje, močnejše znojenje redki: izpuščaj, urtikarija, eritem, eritematozen izpuščaj
Back Pain Rare:
Bolezni mišično- skeletnega sistema in vezivnega tkiva Žilne bolezni
Flushing Uncommon:
občasni: bolečine v hrbtu redki: artralgija, bolečine v bokih, bolečine v vratu, mišični krči pogosti: zardevanje občasni: hipotenzija redki: sinkopa, hipertenzija, hladna periferija
Syncope, Hypertension, Peripheral Coldness
Splošne težave in spremembe na mestu aplikacije
General disorders and administration site conditions
občasni: bolečina v prsih, utrujenost, občutek vročine, bolečina na mestu injiciranja redki: pireksija, mrzlica
Uncommon:
Podatki o teh neželenih učinkih izhajajo iz spontanih poročil, zato pogostnost teh neželenih učinkov ni znana:
Pyrexia, Rigors
Alergijske reakcije (npr. anafilaksija, anafilaktični šok in anafilaktoidne reakcije, hipotenzija in angioedem) (glejte poglavje 4. 4).
The following additional adverse reactions have been reported during post– marketing experience; they are derived from spontaneous reports and therefore, the frequency of these adverse reactions is not known:
Neželeni učinki v osrednjem živčevju (vključno z epileptičnimi napadi in epileptičnim napadom podobnimi učinki), ki so morda povezani s takojšnjimi preobčutljivostnimi reakcijami.
Allergic type reactions (eg: anaphylaxis, anaphylactic shock and anaphylactoid type reactions, hypotension and angioedema) (see section 4.4) Central nervous system reactions (including seizures and seizure-like reactions), which may be associated with immediate hypersensitivity reactions Muscle spasm, musculoskeletal pain and discomfort, and myalgia.
Mišični krči, mišičnoskeletna bolečina ter neugodje in mialgija.
The clinical consequences of overdosing with Luminity are not known.
Klinične posledice prevelikega odmerjanja zdravila Luminity niso znane.
Single doses of up to 100 µl dispersion/ kg and multiple doses up to 150 µl dispersion/ kg were tolerated well in Phase I clinical trials.
V kliničnih preskušanjih I. faze so bolniki dobro prenesli posamične odmerke do 100 µl disperzije/ kg in večkratne odmerke do 150 µl disperzije/ kg.
Pharmacotherapeutic group: ultrasound contrast media, microspheres of phospholipids, ATC Code:
Farmakoterapevtska skupina: ultrazvočna kontrastna sredstva, mikrosfere fosfolipidov, oznaka ATC:
V08D A04
V08DA04.
Microspheres in the 1 to < 10 µm diameter size range contribute to the contrast effect by generating strongly enhanced echoes.
Mikrosfere s premeri od 1 do < 10 µm močno ojačijo odboj in tako pripomorejo h kontrastnemu učinku.
As Luminity consists of microspheres that are stable and small enough for transpulmonary passage, enhanced echo signals in the left heart and systemic circulation are obtained.
Tako omogočijo ojačitev odboja signala na levi strani srca in v sistemskem obtoku.
A strict dose/ response relationship cannot be defined, although higher doses have been shown to produce a contrast effect of longer duration.
Natančnega razmerja med odmerkom in odzivom ni mogoče opredeliti, je pa ugotovljeno, da imajo veliki odmerki dolgotrajnejši kontrasten učinek.
The pharmacokinetic properties of Luminity were evaluated in normal healthy subjects and subjects with chronic obstructive pulmonary disease (COPD) following intravenous administration of a 50 µl/ kg dose of the product.
Farmakokinetične lastnosti zdravila Luminity so ocenili pri normalnih zdravih preiskovancih in pri preiskovancih s kronično obstruktivno pljučno boleznijo (KOPB) po intravenski aplikaciji odmerka 50 µl/ kg.
The percentage of the perflutren dose excreted in expired air was approximately 50% of the administered dose due to the small quantities of perflutren given and the inability to quantify low levels of perflutren by gas chromatography.
Odstotek odmerka perflutrena, ki se je izločil v izdihanem zraku, je bil približno 50% apliciranega odmerka; to je posledica majhne količine apliciranega perflutrena in nemožnosti za kvantificiranje nizkih koncentracij perflutrena s plinsko kromatografijo.
Perflutren concentrations in blood were shown to decline in a mono-exponential fashion with a mean half-life of 1.3 minutes in healthy subjects and 1.9 minutes in COPD subjects.
Ugotovljeno je, da koncentracija perflutrena v krvi upada monoeksponentno, in sicer s povprečnim razpolovnim časom, ki je pri zdravih preiskovancih 1, 3 minute in pri preiskovancih s KOPB 1, 9 minute.
CLlung was found to be significantly reduced (51%) in females compared to males (all subjects).
Izkazalo pa se je, da je CLpljučni bistveno manjši (51%) pri ženskah kot pri moških (vsi preiskovanci).
Doppler ultrasound measurements were performed with Luminity in conjunction with the pharmacokinetic evaluation of
Dopplerske ultrazvočne meritve z zdravilom Luminity so opravili hkrati s farmakokinetično analizo perflutrena.
The time to maximum Doppler signal intensity tmax was shown to be similar to the perflutren blood tmax (1.13 versus 1.77 minutes).
Čas do največje intenzivnosti dopplerskega signala tmax je bil podoben tmax perflutrena v krvi (1, 13 minute v primerjavi z 1, 77 minute).
The observed 99% drop in Doppler signal intensity within 10 minutes (t1/ 2 approximately 2 minutes) was in agreement with the decline in measurable blood levels of perflutren.
Opaženi 99% padec intenzivnosti dopplerskega signala v 10 minutah (t1/ 2 približno 2 minuti) se sklada z upadanjem merljive koncentracije perflutrena v krvi.
Fundamental and non-linear imaging techniques (second harmonic, multipulse phase and/ or amplitude modulation) using both continuous and triggered acquisition were utilised in clinical studies with Luminity.
V kliničnih študijah z zdravilom Luminity so bile uporabljene osnovne in nelinearne preiskovalne metode (“ second harmonic ”, “ multipulse phase ” in/ ali “ amplitude modulation ”) pri čemer je bil uporabljen tako kontinuiran kot pulzirajoč signal.
The naturally occurring phospholipids in Luminity (see section 6.1) are distributed in the endogenous lipid pools in the body (for example, liver) whereas the synthetic component (MPEG5000) has been shown to be excreted in the urine in preclinical studies.
Naravni fosfolipidi, ki jih vsebuje zdravilo Luminity (glejte poglavje 6. 1), se porazdelijo v endogenih zbirih lipidov v telesu (npr. v jetrih), za sintetično sestavino (MPEG5000) pa so v predkliničnih študijah ugotovili, da se izloči v urinu.
Renal Disease:
Bolezni ledvic:
Hepatic Disease:
Bolezni jeter:
Preclinical data reveal no special hazard for humans based on conventional studies of genotoxicity, fertility, embryo/ foetal development, parturition or post-natal development, and local tolerance.
Predklinični podatki na osnovi običajnih študij genotoksičnosti, plodnosti, embrio- fetalnega razvoja, porajanja ali postnatalnega razvoja in lokalnega prenašanja ne kažejo posebnega tveganja za človeka.
Abnormal respiration, heart rate changes and decreased activity were observed soon after intravenous injection of Luminity at doses ≥ 0.3 ml/ kg in single and repeat-dose toxicity studies in rats and monkeys.
V študijah toksičnosti posamičnih in ponavljajočih se odmerkov pri podganah in opicah so po intravenskem injiciranju zdravila Luminity v odmerkih ≥ 0, 3 ml/ kg opažali nenormalno dihanje, spremembe srčne frekvence in manjšo aktivnost.
Higher doses of the product, typically ≥ 1 ml/ kg, resulted in more severe signs including unresponsiveness and occasionally death.
Večji odmerki zdravila, praviloma ≥ 1 ml/ kg, so povzročili hujše znake, vključno z neodzivnostjo in, občasno, s smrtjo.
1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC) 1,2-dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA) N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3- phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE) Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate heptahydrate Sodium chloride Propylene glycol Glycerol Water for injections
1, 2- dipalmitoil- sn- glicero- 3- fosfatidilholin (DPPC) 1, 2- dipalmitoil- sn- glicero- 3- fosfatidilna kislina, mononatrijeva sol (DPPA) N - (metoksipolietilenglikol 5000 karbamoil) - 1, 2- dipalmitoil- sn- glicero- 3 - fosfatidiletanolamin, mononatrijeva sol (MPEG5000 DPPE) natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat heptahidrat natrijev klorid propilenglikol glicerol voda za injekcije
6 6.3 Shelf life
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smete mešati z drugimi zdravili razen s tistimi, ki so navedena v poglavju 6. 6.
Before activation:
Pred aktiviranjem:
After activation:
Po aktiviranju:
12 hours.
12 ur.
Store in a refrigerator (2°C - 8°C) After activation:
Shranjujte v hladilniku (2 °C - 8 °C).
Do not store above 30°C.
Po aktiviranju:
Clear borosilicate Type I glass vial, closed with a chlorobutyl elastomeric lyophilisation stopper, and sealed with an aluminium crimp seal having a plastic flip-off button.
Viala iz bistrega borosilikatnega stekla tipa I, zaprta s klorobutilnim elastomernim liofilizacijskim zamaškom, zapečatena z aluminijsko obrobo in pokrita s plastičnim dvižnim gumbom.
The product is supplied as 1 x 1.5 ml or 4 x 1.5 ml single-dose vials.
Zdravilo je na voljo v pakiranjih z 1x 1, 5- ml in 4 x 1, 5- ml vialami z enkratnim odmerkom.