natgillin/translations-raw huggingface dataset:
In a 6-month clinical study, versus latanoprost, a statistically superior reduction in morning mean IOP (ranging from -7.6 to -8.2 mmHg for bimatoprost versus – 6.0 to – 7.2 mmHg for latanoprost) was observed at all visits throughout the study.
V 6- mesečni primerjalni klinični študiji, z latanoprostom so opazili statistično značilno jutranje znižanje povprečnega znotrajočesnega tlaka (v razponu od – 7, 6 do – 8, 2 mmHg za bimatoprost v primeravi z – 6, 0 do – 7, 2 mmHg za latanoprost) pri vseh vizitah v času študije.
Conjunctival hyperaemia, growth of eyelashes, and eye pruritus were statistically significantly higher with bimatoprost than with latanoprost, however, the discontinuation rates due to adverse events were low with no statistically significant difference.
Prekinitve zdravljenja zaradi neželenih učinkov so bile redke brez statistično značilnih razlik.
Compared to treatment with beta-blocker alone, adjunctive therapy with beta-blocker and bimatoprost lowered mean morning (08:00) intraocular pressure by -6.5 to -8.1 mmHg.
V primerjavi z zdravljenjem samo z zaviralci beta receptorjev, je adjuvantna terapija z zaviralci beta receptorjev in bimatoprostom zmanjšala povprečni jutranji (08: 00) znotrajočesni tlak za – 6, 5 do – 8, 1 mmHg.
Limited experience is available with the use in patients with open-angle glaucoma with pseudoexfoliative and pigmentary glaucoma, and chronic angle-closure glaucoma with patent iridotomy.
Omenjena izkušnja je na voljo pri bolnikih z glavkomom odprtega zakotja s psevdoeksfoliativnim in pigmentnim glavkomom ter kroničnim glavkomom zaprtega zakotja s patentirano iridotomijo.
5 5.2 Pharmacokinetic properties
5 5. 2 Farmakokinetične lastnosti
After ocular administration, the systemic exposure of bimatoprost is very low with no accumulation over time.
Po lokalni uporabi v očesu je sistemska absorbcija bimatoprosta zelo nizka in brez dolgotrajnega kopičenja.
After once daily ocular administration of one drop of 0.03% bimatoprost to both eyes for two weeks, blood concentrations peaked within 10 minutes after dosing and declined to below the lower limit of detection (0.025 ng/ ml) within 1.5 hours after dosing.
Po očesnem odmerku ene kapljice bimatoprosta v 0, 03% koncentraciji enkrat dnevno v obe očesi v dveh tednih, je koncentracija v krvi narasla v 10 minutah po odmerku in se zmanjšala pod spodnjo mejo zaznavnosti (0, 025 ng/ ml) v 1, 5 uri po odmerku.
Mean Cmax and AUC 0-24hrs values were similar on days 7 and 14 at approximately 0.08 ng/ ml and 0.09 ng• hr/ ml respectively, indicating that a steady drug concentration was reached during the first week of ocular dosing.
Povprečne Cmax in AUC 0- 24hrs vrednosti so bile podobne na 7. in 14. dan približno 0, 08 ng/ ml in 0, 09 ng• h/ ml, kar kaže da je stalna koncentracija zdravila bila dosežena v prvem tednu lokalne uporabe v očesu.
Bimatoprost is moderately distributed into body tissues and the systemic volume of distribution in humans at steady-state was 0.67 l/ kg.
Sistemski volumen porazdelitve v stanju dinamičnega ravnovesja pri človeku je bil 0, 67 l/ kg.
The plasma protein binding of bimatoprost is approximately 88%.
Plazmatski proteini vežejo približno 88% bimatoprosta.
Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation following ocular dosing.
Pri očesnem dajanju je bimatoprost po vstopu v sistemsko cirkulacijo glavna krožeča snov v krvi.
Bimatoprost then undergoes oxidation, N-deethylation and glucuronidation to form a diverse variety of metabolites.
Po oksidaciji, N- deetiletaciji in glukuronidaciji se tvorijo različne oblike metabolitov.
Bimatoprost is eliminated primarily by renal excretion, up to 67% of an intravenous dose administered to healthy volunteers was excreted in the urine, 25% of the dose was excreted via the faeces.
Do 67% vnesenega intravenskega odmerka zdravim prostovoljcem je bilo izločeno z urinom, 25% odmerka je bilo izločeno z blatom.
The elimination half-life, determined after intravenous administration, was approximately 45 minutes; the total blood clearance was 1.5 l/ hr/ kg.
Popoln očistek krvi je dosežen v 1, 5 l/ h/ kg.
After twice daily dosing, the mean AUC0-24hr value of 0.0634 ng• hr/ ml bimatoprost in the elderly (subjects 65 years or older) were significantly higher than 0.0218 ng• hr/ ml in young healthy adults.
Po odmerjanju dvakrat dnevno je bila povprečna AUC0- 24hr vrednost 0, 0634 ng• h/ ml bimatoprosta pri starejših (osebe stare 65 let ali starejše) in torej občutno višja kot pri zdravih mlajših odraslih, kjer dosega 0, 0218 ng• h/ ml.
However, this finding is not clinically relevant as systemic exposure for both elderly and young subjects remained very low from ocular dosing.
Dolgotrajnega kopičenja bimatoprosta v krvi ni bilo.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
V nekliničnih raziskavah so zabeležili učinke le pri izpostavljenosti, ki naj bi znatno presegala maksimalno izpostavljenost pri človeku, kar kaže, da je to za klinično uporabo manj pomembno.
Monkeys administered ocular bimatoprost concentrations of ≥ 0.03% daily for 1 year had an increase in iris pigmentation and reversible dose-related periocular effects characterised by a prominent upper and/ or lower sulcus and widening of the palpebral fissure.
V enoletni študiji, kjer so opice enkrat dnevno prejemale v oko bimatoprost v koncentraciji ≥0, 03%, so opazili povečanje pigmentacije irisa in reverzibilni, z odmerkom pogojeni, periokularni učinek, za katerega je značilen trajni zgornji in/ ali spodnji sulkus in širjenje palpebralne fisure.
Bimatoprost did not impair fertility in rats up to doses of 0.6 mg/ kg/ day (approximately 103-times the intended human exposure).
Bimatoprost v koncentracijah do 0, 6 mg/ kg/ dan (približno 103- krat večja od priporočene izpostavitve pri človeku) ni vplival na rodnost pri podganah.
In embryo/ foetal developmental studies abortion, but no developmental effects were seen in mice and rats at doses that were at least 860-times or 1700-times higher than the dose in humans, respectively.
V razvojnih raziskavah na mišjih in podganjih embrijih/ fetusih so zabeležili abortuse, vplivov na embrio- fetalni razvoj pri odmerkih, ki so 860 - ali 1700- krat presegali priporočen odmerek pri človeku, niso opazili.
These doses resulted in systemic exposures of at least 33- or 97-times higher, respectively, than the intended human exposure.
Pri teh odmerkih je prišlo do najmanj 33 - ali 97- krat večje sistemske izpostavljenosti kot pri priporočeni uporabi pri človeku.
In rat peri/ postnatal studies, maternal toxicity caused reduced gestation time, foetal death, and decreased pup body weights at ≥ 0.3 mg/ kg/ day (at least 41-times the intended human exposure).
V peri - / postnatalnih študijah pri podganah je pri odmerkih ≥ 0, 3 mg/ kg/ dan (ustreza najmanj 41- kratni predvideni izpostavljenosti pri človeku), prišlo do maternalne toksičnosti, zaradi česar se je zmanjšal čas brejosti, prišlo do smrti fetusa in zmanjšane telesne teže skotenih mladičev.
Neurobehavioural functions of offspring were not affected.
Nevrobehavioralistične funkcije mladičev niso bile motene.
Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.
Kemična in biološka stabilnost uporabnosti je bila dokazana 28 dni pri 25°C.
From a microbiological point of view, the in-use storage times and conditions are the responsibility of the user and would normally not be longer than 28 days at 25°C.
Iz mikrobiološkega vidika je za pogoje in čas hranjenja med uporabo odgovoren uporabnik in ne sme biti daljša kot 28 dni pri 25°C.
The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml.
Na voljo so naslednje velikosti pakiranja: škatla, ki vsebuje 1 ali 3 plastenke po 3 ml.
Allergan Pharmaceuticals Ireland Castlebar Road Westport County Mayo Ireland
Allergan Pharmaceuticals Ireland Castlebar Road Westport County Mayo Irska
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING, AND ON THE IMMEDIATE PACKAGING
12 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
LUMIGAN 0.3 mg/ ml, eye drops, solution
LUMIGAN 0, 3 mg/ ml, kapljice za oko, raztopina
One ml of solution contains 0.3 mg bimatoprost
En ml raztopine vsebuje 0, 3 mg bimatoprosta.
Benzalkonium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water
Benzalkonijev klorid, natrijev dihidrogenfosfat heptahidrat, citronska kislina monohidrat, natrijev klorid, klorovodikova kislina ali natrijev hidroksid (za uravnavanje pH) in prečiščena voda
Eye drops, solution 1 x 3 ml
Kapljice za oko, raztopina 1 x 3 ml
EXP Discard four weeks after first opening.
EXP Zavrzite štiri tedne po prvem odprtju.
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING, AND ON THE IMMEDIATE PACKAGING
14 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
One ml of solution contains 0.3 mg bimatoprost
En ml raztopine vsebuje 0, 3 mg bimatoprosta
Eye drops, solution 3 x 3 ml
Kapljice za oko, raztopina 3 x 3 ml
There are no special storage instructions
Za shranjevanje ni posebnih navodil
LUMIGAN 0.3 mg/ ml, eye drops, solution Bimatoprost Ocular use
LUMIGAN 0, 3 mg/ ml, kapljice za oko, raztopina Bimatoprost Okularna uporaba
Discard 4 weeks after first opening Exp:
EXP:
LUMIGAN 0.3 mg/ ml, eye drops, solution bimatoprost
LUMIGAN 0, 3 mg/ ml, kapljice za oko, raztopina bimatoprost
Do not pass it on to others.
- Zdravilo je bilo predpisano vam osebno. in ga ne smete dajati drugim.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni
What LUMIGAN is and what it is used for 2.
Kaj je zdravilo LUMIGAN in za kaj ga uporabljamo 2.
Before you use LUMIGAN 3.
Kaj morate vedeti, preden boste uporabili zdravilo LUMIGAN 3.
How to use LUMIGAN 4.
Kako uporabljati zdravilo LUMIGAN 4.
How to store LUMIGAN 6.
Shranjevanje zdravila LUMIGAN 6.
WHAT LUMIGAN IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO LUMIGAN IN ZA KAJ GA UPORABLJAMO
LUMIGAN is an antiglaucoma preparation.
LUMIGAN je zdravilo za zdravljenje glavkoma.
It belongs to a group of medicines called prostamides.
Spada v skupino zdravil, imenovanih prostamidi.
LUMIGAN eye drops are used to reduce high pressure in the eye.
LUMIGAN kapljice za oko se uporabljajo za zmanjševanje previsokega znotrajočesnega tlaka.
This high pressure can lead to a disease called glaucoma.
Ta visok tlak lahko povzroči bolezen, imenovano glavkom.
If the high pressure is not reduced, it could eventually damage your sight.
Če visokega tlaka ne zmanjšamo, lahko pride do poškodbe vašega vida.
Your eye contains a clear, watery liquid that feeds the inside of the eye.
Vaše oko vsebuje bistro, vodeno tekočino ki hrani notranjost očesa.
LUMIGAN works by increasing the amount of liquid that is drained.
LUMIGAN deluje tako, da povečuje količino tekočine, ki odteka.
LUMIGAN may be used on its own or with other drops called beta-blockers which also reduce pressure.
LUMIGAN se lahko uporablja samostojno ali z drugimi kapljicami imenovanimi zaviralci receptorjev beta, ki prav tako znižujejo tlak.
Do not use LUMIGAN:
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO LUMIGAN
- if you are allergic (hypersensitive) to bimatoprost or any of the other ingredients of LUMIGAN.
Ne uporabljajte zdravila LUMIGAN: če ste alergični na (preobčutljivi za) bimatoprost ali katerokoli sestavino zdravila LUMIGAN.
Take special care with LUMIGAN:
Bodite posebno pozorni pri uporabi zdravila LUMIGAN:
- Talk to your doctor, if:
- Obvestite svojega zdravnika, če:
- - -
- imate kakršnekoli težave z dihanjem
You have any breathing problems.
- če imate težave z jetri ali ledvicami.
You have had a cataract surgery in the past
- če ste bili v preteklosti operirani za sivo mreno.
LUMIGAN may cause your eyelashes to darken and grow, and cause the skin around the eyelid to darken too.
LUMIGAN lahko povzroči temnenje in rast trepalnic ter temnenje kože okrog vek.
The colour of your iris may also go darker over time.
Prehodno lahko potemni tudi iris.
These changes may be permanent.
Omenjene spremembe lahko ostanejo trajne.
The change may be more noticeable if you are only treating one eye.
So izrazitejše, če zdravite le eno oko.
People under 18 must not use LUMIGAN.
Osebam, mlajšim od 18 let, ni dovoljena uporaba zdravila LUMIGAN.
19 Using other medicines:
19 Uporaba drugih zdravil:
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, even those not prescribed.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
If you use LUMIGAN with another eye drop, leave at least five minutes between putting in LUMIGAN and then the other drops.
Če uporabljate poleg zdravila LUMIGAN še druge kapljice za oko, počakajte da od vkapanja zdravila LUMIGAN preteče vsaj 5 minut in si šele po tem vkapajte druge kapljice.
Pregnancy Ask your doctor or pharmacist for advice before taking any medicine.
Nosečnost in dojenje Posvetujte se z zdravnikom ali farmacevtom, preden vzamete katerokoli zdravilo.
LUMIGAN should not be used during pregnancy unless your doctor still recommends it.
Zdravila LUMIGAN med nosečnostjo ne smete uporabljati, razen če vam tega ne priporoča vaš zdravnik.
Breast-feeding LUMIGAN may get into breast milk so you should not breast-feed while you are taking LUMIGAN.
LUMIGAN lahko pride v mleko, zato med uporabo zdravila LUMIGAN odsvetujemo dojenje.
Important information about some of the ingredients of LUMIGAN Do not use the drops when you are wearing your lenses.
Pomembne informacije o nekaterih sestavinah zdravila LUMIGAN Ne uporabljajte kapljic, ko nosite kontaktne leče.
HOW TO USE LUMIGAN
KAKO UPORABLJATI ZDRAVILO LUMIGAN
LUMIGAN should only be applied to the eye.
LUMIGAN uporabljajte le za vkapanje v oko.
Always use LUMIGAN exactly as your doctor has told you.
LUMIGAN uporabljajte vedno natančno po zdravnikovih navodilih.
You should check with your doctor or pharmacist if you are not sure.
Če niste prepričani, se posvetujte s svojim zdravnikom ali farmacevtom.
The usual dose is one drop of LUMIGAN in each eye that needs treatment, once every day, in the evening, following the instructions for use below.
Običajni odmerek je ena kapljica zdravila LUMIGAN dnevno,, ki jo vkapamo zvečer v vsako zdravljeno oko po navodilih za uporabo, opisanih v nadaljevanju.
Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment.
Plastenko obrnite z glavo navzdol in jo stisnite, dokler se ne pojavi ena kapljica, ki jo vkapajte v vsako zdravljeno oko.
To help prevent infections, do not let the tip of the bottle touch your eye or anything else.
20 Da bi preprečili infekcije pazite, da se vrhom kapalke ne dotaknete očesa ali česarkoli drugega.
20 If you use more LUMIGAN than you should If you use more LUMIGAN than you should, it is unlikely to cause you any serious harm.
Če ste uporabili večji odmerek zdravila LUMIGAN, kot bi smeli Če ste uporabili večji odmerek zdravila LUMIGAN, kot bi smeli, je malo verjetno, da bo to povzročilo kakršnokoli resnejšo poškodbo.
If you forget to use LUMIGAN If you forget to use LUMIGAN, use a single drop as soon as you remember, and then go back to your regular routine.
Če ste pozabili uporabiti zdravilo LUMIGAN Če ste pozabili uporabiti LUMIGAN, si vkapajte eno kapljico takoj, ko se spomnite in nadaljujte zdravljenje v običajnih razmikih.
If you stop using LUMIGAN LUMIGAN should be used every day to work properly.
Če ste prenehali uporabljati zdravilo LUMIGAN LUMIGAN je treba uporabljati redno vsak dan, da bi deloval pravilno.
Like all medicines, LUMIGAN can have side effects, although not everybody gets them.
Kot vsa zdravila, ima lahko tudi zdravilo LUMIGAN neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Most of the side effects are not serious.
Večina neželenih učinkov ni nevarna.
Very common side effects These may affect more than one person in every 10 people Affecting the eye • Longer eyelashes (up to 45% of people) • Slight redness (up to 44% of people) • Itchiness (up to 14% of people)
Zelo pogosti neželeni učinki Le- ti lahko vplivajo na več kot eno od 10 oseb Učinki na oko • daljše trepalnice (do 45% ljudi) • rahla rdečina (do 44% ljudi) • srbenje (do 14% ljudi)
Common side effects These may affect up to nine people in every 100 people Affecting the eye • An allergic reaction in the eye • Tired eyes • Sensitivity to light • Darker skin colour around the eye • Darker eyelashes • Pain • A feeling that something is in your eye • Sticky eyes • Darker iris colour • Difficulty in seeing clearly • Irritation • Burning • Inflamed, red and itchy eyelids • Tears • Dryness • Swelling of the see-through layer which covers the surface of the eye • Cataract • Small breaks in the surface of the eye, with or without inflammation
Pogosti neželeni učinki Le- ti lahko vplivajo na največ devet od 100 oseb Učinki na oko • alergijska reakcija v očesu • utrujene oči • občutljivost na svetlobo • temnejša koža okrog očesa • temnejše trepalnice • bolečina • občutek tujka v očesu • lepljive oči • temnejša barva irisa • zamegljen vid • draženje • pekoč občutek • vnete, rdeče in razdražene oči • solzenje • suhe oči • otekanje prozornega plašča, ki pokriva površino očesa • katarakta • majhne razpoke na površini očesa z vnetjem ali brez njega
Affecting the body • Headaches • An increase in blood-test results that show how your liver is working • Increased blood pressure
21 Učinki na telo • glavobol • zvišane vrednosti kazalcev v krvi, ki kažejo delovanje jeter • povišan krvni tlak
21 Uncommon side effects These may affect up to nine people in every 1000 people Affecting the eye • Cystoid macular oedema (swelling of the retina within the eye leading to worsening vision) • Inflammation within the eye • Retinal bleeding
Učinki na oko: • cistoidni makularni edem (oteklina mrežnice, ki privede do poslabšanja vida) • vnetje v notranjosti očesa • krvavitev iz mrežnice
HOW TO STORE LUMIGAN
SHRANJEVANJE ZDRAVILA LUMIGAN
Do not use LUMIGAN after the expiry date which is stated on the bottle label and the carton after EXP:.
Zdravila LUMIGAN ne smete uporabljajti po datumu izteka roka uporabnosti, ki je naveden na nalepki plastenke in škatlici poleg oznake EXP:.
You must throw away the bottle four weeks after you first opened it, even if there are still some drops left.
Plastenko morate zavreči štiri tedne po prvem odprtju, četudi je v njej ostalo še nekaj kapljic.
This will prevent infections.
To preprečuje infekcije.
Keep the container tightly closed to prevent contamination
Plastenka naj bo dobro zaprta, da bi preprečili okužbo.
What LUMIGAN contains
Kaj vsebuje zdravilo LUMIGAN
- The active substance is bimatoprost 0.3 mg/ ml.
- Zdravilna učinkovina je bimatoprost 0, 3 mg/ ml
- The other ingredients are benzalkonium chloride (preservative), sodium chloride, sodium
- Pomožne snovi so benzalkonijev klorid (konzervans), natrijev klorid, natrijev dihidrogenfosfat
phosphate dibasic heptahydrate, citric acid monohydrate and purified water.
heptahidrat, citronska kislina monohidrat in prečiščena voda.
What LUMIGAN looks like and contents of the pack LUMIGAN is a colourless to slightly yellow, clear eye drop solution in a pack containing either 1 plastic bottle or 3 plastic bottles each with a screw cap.
LUMIGAN je brezbarvna do rahlo rumena, čista raztopina za oko v pakiranju, ki vsebuje 1 ali 3 plastenke z navojno zaporko.
This is enough for 4 weeks’ usage.
Zadostuje za 4 tedne uporabe.
Mayo Ireland.
Mayo Irska
For any information about this medicine, please contact the local representative of the marketing authorisation holder.
22 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Luxembourg/ Luxemburg Allergan NV/ SA Terhulpsesteenweg 6D B-1560 Hoeilaart Belgique/ Belgien Tél/ Tel: + 32 (0)2 351 24 24 E-mail: uk_medinfo@allergan. com
Luxembourg/ Luxemburg Allergan NV/ SA Terhulpsesteenweg 6D B- 1560 Hoeilaart Belgique/ Belgien Tél/ Tel: + 32 (0) 2- 351. 24. 24 E- mail: uk_ medinfo@ allergan. com
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 (kapalna infuzija v veno), ki vsebuje mikrosfere (majcene mehurčke) plina perflutrena kot zdravilne učinkovine.
It is a contrast agent (a medicine that helps to make internal body structures visible during imaging tests).
Je kontrastno sredstvo (zdravilo, ki omogoča vidnost notranjih telesnih organov med slikanjem).
Luminity is used in adults to obtain a clearer scan 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 jasnejši posnetek srčnih votlin, zlasti levega prekata, med ehokardiografijo (diagnostični pregled 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 with non-contrast echocardiography is not optimal.
Zdravilo Luminity se uporablja pri bolnikih s potrjeno ishemično boleznijo (zaporo krvnih žil, ki oskrbujejo srčno mišico) ali sumom nanjo, pri katerih nekontrastna ehokardiografija ni bila optimalna.
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 allergic reactions.
Zdravilo Luminity smejo predpisovati le zdravniki, usposobljeni za izvajanje in interpretiranje slik, pridobljenih s kontrastno ehokardiografijo, v bolnišnici ali kliniki, kjer je na razpolago oprema za oživljanje v primeru alergičnih reakcij.
Before use, the medicine must be activated by shaking it using a mechanical device called Vialmix, which is supplied to doctors who need to prepare Luminity.
Pred uporabo je treba zdravilo Luminity aktivirati z mehanično napravo za stresanje (imenovano Vialmix), ki jo dobijo zdravniki, ki morajo pripraviti zdravilo Luminity.
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 je poskrbljeno, da je zdravilo pretreseno pravilno in dovolj dolgo, da je „ disperzija “ mikrosfer plina perflutrena prave velikosti za kakovostno sliko.
This is then given into a vein either as a ‘ bolus’ injection (given all at once) or as an infusion, after dilution with a suitable diluent.
Sredstvo se nato daje v veno kot bolusno injiciranje (celotno zdravilo naenkrat) ali kot infundiranje po razredčenju s primernim vehiklom za redčenje.
The way Luminity is given and the dose depend on the technique used for the echocardiography.
Način uporabe zdravila Luminity in odmerki so odvisni od uporabljene tehnike za ehokardiografijo.
Luminity has not been studied in patients with liver or kidney problems, or in the elderly.
Zdravila Luminity niso proučevali pri bolnikih z jetrnimi ali ledvičnimi obolenji ali pri starejših ljudeh.
For full details, see the Summary of Product Characteristics (also part of the EPAR).
Za podrobnejše podatke glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
Before activation, Luminity contains a gas, perflutren, and a solution of fatty substances called phospholipids.
Pred aktivacijo zdravilo Luminity vsebuje plin perflutren ter raztopino maščobnih snovi (imenovanih fosfolipidi).
After activation, the medicine contains microspheres of perflutren gas in a fatty layer of phospholipids.
Po aktivaciji zdravilo vsebuje mikrosfere plina perflutrena v maščobni plasti fosfolipidov.
Perflutren microspheres are used as a contrast agent in echocardiography because, when using ultrasound, they generate echoes very differently from the surrounding tissues.
Po injiciranju zdravilo Luminity potuje po