natgillin/translations-raw huggingface dataset:
Tildrakizumab is catabolized into component amino acids by general protein degradation processes and is not eliminated by renal or hepatic pathways.
Tildrakizumab se katabolizira v sestavino aminokislin v procesu splošne razgradnje beljakovin in se ne izloča po ledvični ali jetrni poti.
Each pre-filled syringe contains 100 mg of tildrakizumab in 1 mL.
Ena napolnjena injekcijska brizga vsebuje 100 mg tildrakizumaba v 1 ml.
The maintenance of response in studies reSURFACE1 and reSURFACE2 are presented in Table 3.
Ohranjen odziv v študijah reSURFACE1 in reSURFACE2 je predstavljen v preglednici 3.
Tildrakizumab exhibited dose-proportional pharmacokinetics in subjects with plaque psoriasis over a dose range from 50 mg to 400 mg following subcutaneous administration, with clearance being independent of dose.
Pri osebah s psoriazo v plakih je bila farmakokinetika tildrakizumaba po subkutanem dajanju odvisna od odmerka v razponu odmerka od 50 mg do 400 mg, z očistkom, odvisnim od odmerka.
Common aIncluding nasopharyngitis.
Pogosti aVključno z nazofaringitisom.
As a precautionary measure, it is preferable to avoid the use of Ilumetri during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Ilumetri bolje izogibati.
At steady state, following administration of 100 mg of tildrakizumab in subjects with moderate to severe plaque psoriasis geometric means (% CV) of AUC0-τ and Cmax values were respectively 305 μg·day/mL (41%) and 8.1 μg/mL (34%), whereas they were 612 μg·day/mL (40%) and 16.3 μg/mL (33%) following administration of 200 mg.
V stanju dinamičnega ravnovesja so bile po dajanju 100 mg tildrakizumaba pri osebah z zmerno do hudo psoriazo v plakih geometrične srednje vrednosti (% CV) vrednosti AUC0-τ in Cmax 305 µg·dan/ml (41%) oz. 8,1 μg/ml (34 %), pri čemer so bile 612 μg·dan/ml (40 %) oz. 16,3 µg/ml (33 %) po dajanju 200 mg. Porazdelitev
Maintenance and durability of PASI 90 response over time is presented in Figure 1.
Ohranjen odziv PASI 90 in njegovo vzdrževanje je predstavljeno na sliki 1.
After proper training in subcutaneous injection technique, patients may self-inject Ilumetri if a physician determines that it is appropriate.
Ko se bolniki naučijo tehnike pravilnega subkutanega injiciranja, si lahko zdravilo Ilumetri injicirajo sami, če zdravnik oceni, da je to ustrezno.
Package leaflet: Information for the user Ilumetri 100 mg solution for injection in pre-filled syringe tildrakizumab This medicine is subject to additional monitoring.
Navodilo za uporabo Ilumetri 100 mg raztopina v napolnjeni injekcijski brizgi tildrakizumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
Ilumetri is administered by subcutaneous injection.
Zdravilo Ilumetri je namenjeno za subkutano injiciranje.
Ilumetri is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis.
Zdravilo Ilumetri je namenjeno za uporabo pod vodstvom in nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem psoriaze v plakih.
The geometric mean exposure (AUC0-τ at steady state) in adult patients weighing >90 kg following a 100 mg or 200 mg SC dose was predicted to be about 30% lower than in an adult patient weighing ≤90 kg (see section 4.2).
Pri odraslih bolnikih, ki tehtajo > 90 kg, je bila po s.c. odmerku 100 mg ali 200 mg pričakovana geometrična povprečna izpostavljenost (AUC0-τ v stanju dinamičnega ravnovesja) približno 30 % nižja kot pri odraslih bolnikih, ki tehtajo ≤ 90 kg (glejte poglavje 4.2).
SMALL IMMEDIATE PACKAGING UNITS LABEL - PRE-FILLED SYRINGE
MANJŠA STIČNA OVOJNINA NALEPKA - NAPOLNJENA INJEKCIJSKA BRIZGA
Each pre-filled syringe contains 100 mg of tildrakizumab.
Ena napolnjena injekcijska brizga vsebuje 100 mg tildrakizumaba.
Ilumetri 200 mg
Zdravilo Ilumetri 200 mg
It is unknown whether tildrakizumab is excreted in human milk.
Ni znano, ali se tildrakizumab izloča v materino mleko.
Common side effects (may affect up to 1 in 10 people): - Gastroenteritis - Nausea - Diarrhoea - Injection site pain - Back pain - Headache
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): - vnetje želodca in črevesa; - siljenje na bruhanje; - driska; - bolečina na mestu injiciranja; - bolečina v hrbtu;
You should not be given certain types of vaccines (live vaccines) while using Ilumetri.
Med uporabo zdravila Ilumetri ne smete biti cepljeni z nekaterimi cepivi (živa cepiva).
If any of these side effects becomes severe, tell your doctor or pharmacist.
Če postane kateri od teh neželenih učinkov resen, se posvetujte z zdravnikom ali farmacevtom.
Tildrakizumab is catabolized into component amino acids by general protein degradation processes.
Tildrakizumab se razgradi v sestavne aminokisline v procesu splošne razgradnje beljakovin.
Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Zdravilo Ilumetri je indicirano za zdravljenje zmerne do hude psoriaze s plaki pri odraslih, ki so primerni za sistemsko zdravljenje.
o Do not touch this area again before giving the injection.
o Do injiciranja se ne dotaknite več tega predela.
• Hold the pre-filled syringe steady.
• Napolnjeno injekcijsko brizgo trdo držite.
o DO NOT use if pre-filled syringe or needle is bent.
o NE uporabite, če je napolnjena injekcijska brizga ali igla upognjena.
Ilumetri 100 mg
Zdravilo Ilumetri 100 mg
• The pre-filled syringes must not be shaken.
• Napolnjenih injekcijskih brizg ni dovoljeno stresati.
Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown.
Ne uporabljajte, če vsebuje tekočina preprosto vidne delce, je motna ali izrazito rjava.
“minimal” with ≥2 grade improvement from Baselinea (%)
PGA “čisto” ali “minimalno” z izboljšanjem stopnje ≥ 2 od izhodišča (%) PASI 90 (%)
Pack size of 1 pre-filled syringe or 2 pre-filled syringes.
Velikost pakiranja je 1 napolnjena injekcijska brizga ali 2 napolnjeni injekcijski brizgi.
Anti-TB therapy should be considered prior to initiating Ilumetri in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Pred uvedbo zdravila Ilumetri pri bolnikih z latenntno ali aktivno TB v anamnezi, pri katerih ustreznega poteka zdravljenja ni mogoče potrditi, je treba razmisliti o zdravilih proti
Ilumetri is a sterile solution for injection in pre-filled syringe.
Zdravilo Ilumetri je sterilna raztopina za injiciranje v napolnjeni injekcijski brizgi.
You must look out for signs of these conditions while you are taking Ilumetri.
Med uporabo zdravila Ilumetri morate biti pozorni na znake teh bolezni.
List of adverse reactions MedDRA System Organ Class
Seznam neželenih učinkov Organski sistem po MedDRA Prednostni izraz
The pre-filled syringe must not be shaken.
Napolnjene injekcijske brizge ni dovoljeno stresati.
Each pre-filled syringe is for single use only.
Ena napolnjena injekcijska brizga je namenjena samo za enkratno uporabo.
Solution for injection 1 pre-filled syringe
Raztopina za injiciranje 1 napolnjena injekcijska brizga
Clean injection site
Očistite mesto injiciranja
Do not use if the liquid contains visible particles, is cloudy or is distinctly brown.
Ne uporabite, če vsebuje tekočina vidne delce, je motna ali razločno rjava.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, and repeated dose toxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
No harmful effects were noted in neonates at maternal exposures up to 9 times the human exposure at the recommended dose.
Po izpostavljenosti matere odmerkom, ki so za 9-krat presegali izpostavljenost priporočenim odmerkom za ljudi, niso pri novorojencih opazili nobenih škodljivih učinkov.
Pull off the needle cover
Povlecite za pokrovček za iglo in ga odstranite
Ilumetri 100 mg solution for injection in pre-filled syringe.
Ilumetri 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi.
Solution for injection 2 pre-filled syringes
Raztopina za injiciranje 2 napolnjeni injekcijski brizgi
The pre-filled syringes are for single use only.
Napolnjene injekcijske brizge so namenjene enkratni uporabi.
• Insert the entire needle into the pinched skin between your fingers, straight up and down at a
• V kožo, stisnjeno s prsti, si vstavite celo iglo naravnost navzdol pod kotom 90 stopinj.
The subcutaneous formulation of tildrakizumab showed an absolute bioavailability ranging from 73% (90% CI: 46% - 115%, 200 mg SC vs. 3 mg/kg IV) to 80% (90% CI: 62% - 103%, 50 mg SC vs. 0.5 mg/kg IV) in healthy subjects, as a result of cross study single dose comparison.
Subkutana formulacijo tildrakizumaba je pokazala absolutno biološko razpoložljivost v razponu od 73 % (90-% IZ: 46 % - 15 %, 200 mg s.c. v primerjavi s 3 mg/kg i.v.)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PACK SIZE 1 PRE-FILLED SYRINGE
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - VELIKOST PAKIRANJA 1 NAPOLNJENA INJEKCIJSKA BRIZGA
Renal or hepatic impairment
Ledvična ali jetrna okvara
- The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80,
- Druge sestavine so L-histidin, L-histidinijev klorid monohidrat, polisorbat 80, saharoza in voda za injekcije.
• Gently pinch your skin at the chosen injection site.
• Kožo na izbranem mestu injiciranja nežno stisnite.
Infections and infestations Upper respiratory tract infectionsa Very common Nervous system disorders Headache
Infekcijske in parazitske bolezni okužbe zgornjih dihala
Write down the date of removal from the refrigerator in the space provided on the outer carton and appropriate discard date.
V okence na škatli zabeležite datum, ko ste zdravilo, vzeli iz hladilnika, in ustrezni datum, ko ga je treba zavreči.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PACK SIZE 2 PRE-FILLED SYRINGES
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - VELIKOST PAKIRANJA 2 NAPOLNJENI INJEKCIJSKI BRIZGI
• Read the Ilumetri Package Leaflet to learn more about your medicine.
• Če želite izvedeti več o tem zdravilu, preberite navodilo za uporabo zdravila Ilumetri, priloženo pakiranju.
How to store Ilumetri
Shranjevanje zdravila Ilumetri
Contents of the pack and other information
Shranjevanje zdravila Ilumetri Vsebina pakiranja in dodatne informacije
200 mg 100 mg Etanercep t reSURFACE1
28 teden (3 odmerki)* 200 mg 100 mg Placebo Etanercept 200 mg 100 mg Etanercept reSURFACE1
The instructions for using the pre-filled syringes, included with the package leaflet, must be followed carefully.
Natančno upoštevajte navodila za uporabo napolnjenih injekcijskih brizg, vključena v navodilu za uporabo.
Description of selected adverse reaction Immunogenicity
Opis izbranih neželenih učinkov
Long term responsea,b 200 mg
Dolgoročni odziva,b
Comprehensive instructions for administration are given in the package leaflet.
Izčrpna navodila za dajanje so v navodilu za uporabo.
Keep the product in the original carton in order to protect from light until the time of use.
Do uporabe shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Ilumetri 100 mg solution for injection in pre-filled syringe tildrakizumab
Ilumetri 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi tildrakizumab
No effects on fertility parameters such as reproductive organs, menstrual cycle length, and/or hormones were observed in male and female cynomolgus monkeys that were administered tildrakizumab at doses resulting in >100 times the human exposure at the recommended clinical dose based on AUC.
Pri samcih in samicah opic cynomolgus, ki so jim dajali tildrakizumab v odmerkih, ki so povzročili >100-kratno izpostavljenost priporočenim kliničnim odmerkom pri ljudeh na podlagi AUC, niso opazili nobenih učinkov na parametre plodnosti, kot so reproduktivni organi, dolžina menstrualnega cikla in/ali hormoni.
- The active substance is tildrakizumab.
- Učinkovina je tildrakizumab.
Renal and Hepatic impairment
Ledvična in jetrna okvara
39.4c a Co-primary efficacy endpoint at week 12. b Non responder imputation for missing data.
39,4c a Sočasni opazovani dogodek učinkovitosti v 12 tednu.
INJECTION
Injiciranje
• Inspect Ilumetri visually for particulate matter and discoloration prior to administration.
• Zdravilo Ilumetri pred dajanjem vizualno preglejte, da se prepričate, da ne vsebuje trdih delcev oz. da ni obarvano.
The solution is clear to slightly opalescent and colourless to slightly yellow.
Raztopina je bistra do rahlo opalescentna in brezbarvna do rahlo rumenkasta.
• Choose an injection site with clear skin and easy access such as abdomen, thighs or upper arm. - DO NOT administer 5 cm around the navel or where the skin is tender, bruised, abnormally red, hardened or affected by psoriasis.
• Izberite mesto injiciranja s čisto kožo, ki je enostavno dosegljivo, na primer trebuh, stegna ali nadlaket.
- Ilumetri is a clear to slightly opalescent and colourless to slightly yellow solution.
- Zdravilo Ilumetri je je bistra do nekoliko motna in brezbarvna do rahlo rumenkasta raztopina.
Ilumetri is a clear to slightly opalescent and colourless to slightly yellow solution.
Zdravilo Ilumetri je bistra do rahlo opalescentna in brezbarvna do rahlo rumenkasta raztopina.
Back pain
Pogosti bolečina v hrbtu
Keep the pre-filled syringes in the outer carton in order to protect from light until the time of use.
Napolnjene injekcijske brizge do uporabe shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Do not shake or freeze the pre-filled syringe.
Injekcijske brizge ne stresajte in ne zamrzujte.
Tildrakizumab was shown to distribute across the placental barrier.
Pokazalo se je, da se tildrakizumab prehaja skozi posteljico.
• On a clean, well-lit work surface, place the: - alcohol wipes - cotton ball or gauze pad
- alkoholni zloženec, - kosem vate ali zloženec iz gaze, - lepljivi obliž, - zbiralnik za ostre predmete.
The European Commission granted a marketing authorisation valid throughout the European Union for Luminity on 20 September 2006.
Evropska komisija je dovoljenje za promet z zdravilom Luminity, veljavno po vsej Evropski uniji, izdala 20. septembra 2006.
The gas is then cleared through the lungs.
Plin se nato očisti skozi pljuča.
There have been five main studies of Luminity, involving a total of 401 patients.
Opravljenih je bilo pet glavnih študij zdravila Luminity, v katerih je skupaj sodeloval 401 bolnik.
What measures are being taken to ensure the safe and effective use of Luminity?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Luminity?
The full EPAR for Luminity can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Luminity je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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.
Other information about Luminity
Druge informacije o zdravilu Luminity
This is a summary of the European public assessment report (EPAR) for Luminity.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Luminity.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Luminity have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Luminity, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
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 od 100) sta glavobol in zardevanje (pordelost kože).
What benefit has Luminity shown during the studies?
Kakšne koristi je zdravilo Luminity izkazalo med študijami?
For full details, see the summary of product characteristics (also part of the EPAR).
Za več informacij glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
This ensures that the medicine is shaken in the correct way and for long enough to make up a ‘dispersion' of microspheres of perflutren gas of the right size to get a good quality image.
S tem se zagotovi, da se zdravilo stresa na pravilen način in dovolj dolgo, s čimer se ustvari „disperzija“ mikrosfer plina perflutrena pravilne velikosti, ki omogoči kakovostno sliko.
It is a contrast agent (a medicine that helps obtain better images of organs and tissues during a scan).
Je kontrastno sredstvo (zdravilo, ki zagotavlja boljše slike organov in tkiv med slikanjem).
This helps to obtain a better contrast between the area where the gas bubbles are (such as the heart chambers) and the surrounding tissue.
S tem dobimo boljši kontrast med področjem, kjer so mehurčki plina (npr. v srčnih votlinah), in okoliškim tkivom.
Luminity should only be given by doctors trained in performing and reading images obtained with contrast echocardiography, in hospitals or clinics where appropriate resuscitation equipment is available in case of heart or lung problems or allergic reactions.
Zdravilo Luminity smejo predpisovati le zdravniki, usposobljeni za slikanje in razlago slik, pridobljenih s kontrastno ehokardiografijo, v bolnišnici ali kliniki, kjer je na razpolago oprema za oživljanje v primeru srčnih ali pljučnih težav ali alergijskih reakcij.
For more information about treatment with Luminity, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist
Za več informacij o zdravljenju z zdravilom Luminity preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The last two studies were set up primarily to look at the ability of Luminity to improve 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 proučiti sposobnost zdravila Luminity pri izboljševanju natančnosti meritev iztisnega deleža (odstotek volumna krvi, ki ga srce iztisne ob enem utripu).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Luminity.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Luminity was effective in enhancing the image of the left ventricle, and it was more effective than placebo in the studies where Luminity and placebo were compared.
Zdravilo Luminity je bilo učinkovito pri ojačevanju slike levega prekata in učinkovitejše od placeba v študijah, v katerih so primerjali zdravilo Luminity in placebo.
Luminity is for diagnostic use only.
Zdravilo Luminity je namenjeno samo za diagnostične namene.
The CHMP decided that Luminity's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Luminity večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The way Luminity is given and the dose depend on the technique being used for the echocardiography.
Način uporabe zdravila Luminity in odmerki so odvisni od uporabljene tehnike za ehokardiografijo.
These studies also looked at left ventricle image enhancement.
V teh študijah pa so proučevali tudi ojačevanje slike levega prekata.
Before use, Luminity must be activated by shaking it using a mechanical device called Vialmix, which is supplied to doctors who need to prepare the medicine.
Pred uporabo je treba zdravilo Luminity aktivirati z mehanično napravo za stresanje (Vialmix), ki jo dobijo zdravniki, ki morajo pripraviti zdravilo.
What is the risk associated with Luminity?
Kakšna tveganja so povezana z zdravilom Luminity?
Luminity perflutren-containing lipid microspheres
Luminity lipidne mikrosfere, ki vsebujejo perflutren
During echocardiography, the perflutren microspheres in Luminity reflect ultrasound waves differently from the surrounding tissues.
Med ehokardiografijo mikrosfere perflutrena, vsebovane v zdravilu Luminity, odbijajo ultrazvočne valove drugače kot okoliška tkiva.
For the full list of all side effects and restrictions with Luminity, see the package leaflet.
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Luminity glejte navodilo za uporabo.
In two of these studies, Luminity was compared with placebo (a dummy treatment).
V dveh študijah pa so zdravilo Luminity primerjali s placebom (zdravilom brez zdravilne učinkovine).
This is then given into a vein either as a ‘bolus' injection (given all at once) or as an infusion after being diluted.
Ta se nato da v veno kot „bolusna“ injekcija (bolnik prejme celo injekcijo naenkrat) ali kot infuzija po razredčenju.
When Luminity is injected, it travels in the veins to the heart.
Po injiciranju zdravilo Luminity potuje po žilah do srca.
Luminity is a solution for injection or infusion (drip) into a vein that contains microspheres (tiny bubbles) of perflutren gas as the active substance.
Zdravilo Luminity je raztopina za injiciranje ali infundiranje (kapalno infuzijo) v veno, ki vsebuje mikrosfere (majcene mehurčke) plina perflutrena kot zdravilne učinkovine.
Why has Luminity been approved?
Zakaj je bilo zdravilo Luminity odobreno?
Luminity is used in adults to obtain a clearer image of the chambers of the heart, especially of the left ventricle, during echocardiography (a diagnostic test where an image of the heart is obtained using ultrasound).
Zdravilo Luminity se uporablja pri odraslih za doseganje jasnejše slike srčnih votlin, zlasti levega prekata, med ehokardiografijo (diagnostičnim pregledom srca, pri katerem sliko srca dobimo z ultrazvokom).
Luminity is used in patients with suspected or confirmed coronary artery disease (obstruction of the blood vessels supplying the heart muscle), when the image obtained without a contrast agent is not good enough.
Zdravilo Luminity se uporablja pri bolnikih s potrjeno ishemično boleznijo ali sumom nanjo (zaporo v krvnih žilah, ki oskrbujejo srčno mišico), kadar slika, izdelana brez kontrastnega sredstva, ni dovolj dobra.
Three studies looked at its ability to enhance the image of the left ventricle, comparing the echocardiography scan before and after administration of Luminity.
V treh študijah so proučevali sposobnost zdravila za ojačitev slike levega prekata, in sicer s primerjanjem ehokardiografskih posnetkov pred uporabo zdravila Luminity in po njem.
How has Luminity been studied?
Kako je bilo zdravilo Luminity raziskano?
What is Luminity used for?
Za kaj se zdravilo Luminity uporablja?
What is Luminity?
Kaj je zdravilo Luminity?
How is Luminity used?
Kako se zdravilo Luminity uporablja?
How does Luminity work?
Kako zdravilo Luminity deluje?
2 carton pack.
Pakiranje z dvema škatlama.
Content (concentration)
Pot uporabe Ovojnina Vsebina (koncentraci ja)
40 mg/0.8 ml
Velikost pakiranja mg/0,8 ml raztopina za injiciranje viala (steklo) 0,8 ml (40 mg / 0,8 ml)
Route of Administration
Številka EU
2 pre-filled syringes + 2
2 napolnjeni injekcijski brizgi s ščitnikom za iglo + 2 alkoholna zloženca
1 alcohol pad
1 viala +
MA (EU) number (Invented) name Strength Pharmaceutical Form
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