natgillin/translations-raw huggingface dataset:
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 cardiopulmonary or hypersensitivity reactions (see section 4.4).
Luminity smiju primjenjivati samo osposobljeni liječnici koji posjeduju stručno znanje o provođenju i tumačenju kontrastnih ehokardiograma, a pritom treba biti dostupna odgovarajuća oprema za reanimaciju za slučaj kardiopulmonalnih reakcija ili reakcija preosjetljivosti (vidjeti dio 4.4).
Luminity should not be used with fundamental imaging technique for stress echocardiography since efficacy and safety have not been established.
Luminity se ne smije koristiti uz osnovnu tehniku snimanja za ehokardiografiju pod opterećenjem budući da njegova djelotvornost i sigurnost primjene nisu utvrđene.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Unutar svake skupine po učestalosti, nuspojave su navedene od najozbiljnijih prema manje ozbiljnima.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept (vidjeti Priog I.: Sažetak opisa svojstava lijeka, dio 4.2).
The product can be re-activated up to 48 hours after initial activation and used up to 12 hours after the second activation.
Lijek se može reaktivirati do 48 sati nakon početne aktivacije te koristiti do 12 sati nakon druge aktivacije.
Caution must be exercised when considering the administration of Luminity to these patients.
Potreban je oprez kada se razmatra primjena Luminityja tim bolesnicima.
1.5 ml liquid in 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.
1,5 ml tekućine u prozirnoj bočici od borosilikatnog stakla tipa I, zatvorena klorobutilnim elastomernim liofilizacijskim čepom te zapečaćena aluminijskim prstenom s plastičnom „flip-off”
Rare: Abnormal electrocardiogram
Rijetko: poremećeni elektrokardiogram
The safety of Luminity in patients with right-to-left, bi-directional or transient right-to-left cardiac shunts has not been studied.
Sigurnost primjene Luminityja u bolesnika s desno-lijevim, dvosmjernim ili prolaznim desno-lijevim srčanim spojevima nije ispitivana.
Patients with adult respiratory distress syndrome, endocarditis, prosthetic heart valves, systemic inflammation, sepsis, hyperactive coagulation and/or recurrent thromboembolism Luminity should be used only after careful consideration and such use should be monitored closely during administration in patients with adult respiratory distress syndrome, endocarditis, a heart with prosthetic valves, acute states of systemic inflammation or sepsis, known states of hyperactive coagulation and/or recurrent thromboembolism.
Bolesnici s adultnim sindromom respiratornog distresa, endokarditisom, protetskim srčanim zaliscima, sistemskom upalom, sepsom, hiperaktivnom koagulacijom i/ili rekurentnom tromboembolijom Luminity se smije koristiti tek nakon pažljivog razmatranja, a njegovu uporabu treba pažljivo pratiti tijekom primjene u bolesnika s adultnim sindromom respiratornog distresa, endokarditisom, srcem s protetskim zaliscima, akutnim stanjima sistemske upale ili sepse, poznatim stanjima hiperaktivne koagulacije i/ili rekurentne tromboembolije.
- The dispersion should be withdrawn from the vial using a syringe with a 18 to 20 gauge sterile needle or attached to a sterile non-siliconised mini-spike.
- Disperziju treba izvlačiti iz bočice pomoću štrcaljke sa sterilnom iglom od 18G do 20G ili pričvršćenom na sterilni nesilikonizirani mini šiljak.
Serious immediate hypersensitivity reactions (eg: anaphylaxis, anaphylactic shock and anaphylactoid reactions, hypotension and angioedema) have been reported following the administration of Luminity.
Ozbiljne neposredne reakcije preosjetljivosti (npr. anafilaksa, anafilaktički šok i anafilaktoidne reakcije, hipotenzija i angioedem) zabilježeni su nakon primjene Luminityja.
Rats treated with Luminity for 1 month exhibited dose-related, reversible perivascular and peribronchiolar eosinophil infiltration, alveolar macrophage accumulation and increased goblet cell size and number in the lungs.
Štakori koji su primali Luminity tijekom 1 mjeseca imali su s dozom povezanu, reverzibilnu perivaskularnu i peribronhiolarnu infiltraciju eozinofila, alveolarno nakupljanje makrofaga te povećanu veličinu i broj vrčastih stanica u plućima.
Intravenous infusion using non-linear contrast imaging technique (rest and stress) or fundamental imaging technique at rest:
Intravenska infuzija uz korištenje nelinearne tehnike kontrastnog snimanja (pri mirovanju i pod opterećenjem) ili osnovne tehnike snimanja u mirovanju:
Excipient(s) with known effect Each ml contains 2.679 mg sodium
Jedan ml sadržava 2,679 mg natrija
Heart or breathing problems including cardiac arrest have occurred in some patients.
U nekih bolesnika javili su se problemi sa srcem ili disanjem, uključujući srčani zastoj.
Extreme caution should be used when considering the administration of Luminity to patients with unstable cardiopulmonary status, for example: unstable angina, acute myocardial infarction, severe ventricular arrhythmias, severe heart failure (NYHA IV) or respiratory failure.
Izniman oprez potreban je kada se razmatra primjena Luminityja u bolesnika s nestabilnim kardiopulmonalnim statusom, primjerice: s nestabilnom anginom, akutnim infarktom miokarda, teškim ventrikularnim aritmijama, teškim srčanim zatajenjem (NYHA IV) ili respiratornim zatajenjem.
This medicine contains 103.5 mg/ml propylene glycol, which is equivalent to 182.2mg in each vial.
Ovaj lijek sadržava 103,5 mg propilenglikola, što odgovara 182,2 mg u svakoj bočici.
After activation (shaking), the product appears as a milky white liquid.
Nakon aktivacije (miješanja) lijek izgleda kao mliječno bijela tekućina.
These effects were observed at exposure levels in excess of the maximum human exposure indicating little relevance to clinical use.
Ti su učinci zapaženi pri izloženosti dozama koje su znatno veće od maksimalno dozvoljenih u ljudi, što ukazuje na njihov mali značaj za kliničku primjenu.
The approximate amount of perflutren gas in each ml is 150 microlitres (μl).
Približna količina plina perflutrena u svakom ml je 150 mikrolitara (μl).
- The vial should be activated using the Vialmix.
- Bočica se mora aktivirati korištenjem Vialmixa.
Luminity is a gas and solvent for dispersion for injection or infusion.
Luminity je plin i otapalo za disperziju za injekciju ili infuziju.
The approximate amount of perflutren gas in each ml of Luminity is 150 microlitres.
Približna količina plina perflutrena u svakom ml Luminityja je 150 mikrolitara.
Lantheus EU Limited Rocktwist House, Block 1, Western Business Park Shannon, Co. Clare V14 FW97 Ireland
Lantheus EU Limited Rocktwist House, Block 1, Western Business Park Shannon, Co.
The dispersion should be given to you within 12 hours of activation (shaking).
Disperzija Vam se mora primijeniti u roku od 12 sati od aktivacije (miješanja).
Total lung clearance (CLlung) of perflutren was shown to be no different in healthy subjects compared to COPD subjects.
Pokazalo se da se ukupni klirens perflutrena iz pluća (CLpluća) ne razlikuje u zdravih ispitanika u usporedbi s ispitanicima s KOPB-om.
Not known: Abnormal vision
Nepoznato: poremećen vid
Rare: Paraesthesia
Rijetko: dispepsija
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.
Uočeni pad od 99% u intenzitetu Doppler signala u roku od 10 minuta (t1/2 otprilike
The reported adverse reactions following the use of Luminity in pivotal and supportive trials (total of 2,526 patients) occur within minutes after administration and usually resolve without therapeutic intervention within 15 minutes.
2526 bolesnika) javljale su se u roku od nekoliko minuta od primjene i obično se povukle uz terapijsku intervenciju u roku od 15 minuta.
Not known: Cardiac arrest, ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia, premature ventricular contactions), asystole, atrial fibrillation, cardiac ischaemia, supraventricular tachycardia, supraventricular arrhythmia
Nepoznato: srčani arest, ventrikularne aritmije (fibrilacija ventrikula, ventrikularna tahikardija, preuranjene kontrakcije ventrikula), asistola, fibrilacija atrija, srčana ishemija,
Patients with unstable cardiopulmonary status should be monitored during and for at least 30 minutes following Luminity administration.
Bolesnike s nestabilnim kardiopulmonalnim statusom potrebno je pratiti tijekom te najmanje 30
Like all parenteral products, the vials must be inspected visually for particulates and vial integrity.
Kao što je slučaj sa svim parenteralnim lijekovima, bočice se moraju vizualno pregledati da bi se provjerilo ima li čestica i je li bočica neoštećena.
The systemic clearance of perflutren was similar in healthy and COPD subjects.
Sistemski klirens perflutrena bio je sličan u zdravih ispitanika i u ispitanika s KOPB-om.
• altered heart rate, palpitations (you feel your heart beats harder or in an irregular way),
• Utrnulost, trnci i/ili osjećaj peckanja, • promijenjena srčana frekvencija, palpitacije (osjećate da Vam srce kuca jače ili nepravilno),
CLlung was found to be significantly reduced (51%) in females compared to males (all subjects).
Uočeno je da je CLpluća bio značajno smanjen (51%)
This product must only be administered intravenously.
Ovaj se lijek smije primjenjivati samo intravenski.
Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath K32 YD60 Ireland
Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co.
• loss of consiousness,
• gubitak svijesti,
After activation: Do not store above 30°C.
Nakon aktivacije: Ne čuvati na temperaturi iznad 30°C.
Do not store the vial above 30°C following activation.
Ne čuvati bočicu na temperaturi iznad 30°C nakon aktivacije.
Uncommon: Hypotension Rare: Syncope, hypertension, peripheral coldness
Rijetko: sinkopa, hipertenzija, periferna hladnoća
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.
U kliničkim ispitivanjima s Luminityjem korištene su osnovne i nelinearne tehnike snimanja („second harmonic”, „multipulse phase” i/ili „amplitude modulation”) koje koriste i kontinuirane i pulsirajuće signale.
Therefore, caution should be exercised when Luminity is administered to breast-feeding women.
Stoga je potreban oprez kada se Luminity primjenjuje ženama koje doje.
- if you are allergic to perflutren or any of the other ingredients of Luminity.
Nemojte primiti Luminity ako ste alergični na perflutren ili neki drugi sastojak Luminityja (naveden u dijelu 6).
Before administering Luminity, the medicinal product must be activated by using a mechanical shaking device, the Vialmix, see section 6.6.
Prije primjene Luminity se mora aktivirati pomoću uređaja za mehaničko miješanje Vialmix (vidjeti dio 6.6).
Uncommon: Back pain
Manje često: bol u leđima
How to use Luminity
Kako primjenjivati Luminity
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.
Farmakokinetička svojstva Luminityja bila su ocijenjena u normalnih zdravih ispitanika i u ispitanika s kroničnom opstruktivnom plućnom bolešću (KOPB) nakon intravenske primjene doze lijeka od
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree' .
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
Bolus intravenous injection using fundamental imaging technique at rest:
Intravenska bolus injekcija uz korištenje nelinearne tehnike kontrastnog snimanja pri mirovanju i pod opterećenjem:
In most subjects after 4-5 minutes, perflutren was undetectable in blood and expired air. 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.
Pokazalo se da koncentracije perflutrena u krvi padaju monoeksponencijalno uz srednji poluvijek od 1,3 minute u zdravih ispitanika te od 1,9 minuta u ispitanika s KOPB-om.
• Dizziness,
• svrbež,
Rare side effects (may affect up to 1 in 1000 people)
Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba)
How to store Luminity
Kako čuvati Luminity
Rare: Arthralgia, flank pain, neck pain, muscle cramp Not known: Muscle spasm, musculoskeletal pain, musculoskeletal discomfort, myalgia, hypertonia
Rijetko: artralgija, bol u boku, bol u vratu, grčevi mišića Nepoznato: mišićni spazam, mišićno-koštana bol, mišićno koštana nelagoda, mijalgija, hipertonija
The product should be used within 12 hours of activation.
Lijek se mora iskoristiti u roku od 12 sati od aktivacije.
Not known: seizures, facial hypoaesthesia, loss of consciousness
Rijetko: parestezija Nepoznato: napadaji, hipoestezija lica, gubitak svijesti
The total dose of perflutren should not exceed 1.6 ml.
Ukupna doza perflutrena ne smije premašivati
Immune system disorders Not known: Allergic type reactions, anaphylaxis, anaphylactic shock and anaphylactoid type reactions, hypotension, angioedema, lip swelling, bronchospasm, rhinitis, upper airway swelling, throat tightness, facial swelling, eye swelling
Nepoznato: alergijske reakcije, anafilaksa, anafilaktički šok i anafilaktoidne reakcije, hipotenzija, angioedem, oticanje usana, bronhospazam, rinitis, oticanje gornjih dišnih puteva, stezanje grla, oticanje lica, oticanje oka
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.
Ako je potrebno, druga doza od 10 mikrolitara disperzije/kg nakon koje slijedi drugi bolus od 10 ml 9 mg/ml (0,9%) otopine natrijevog klorida ili 50 mg/ml (5%) otopine glukoze za injekciju može se primijeniti 5 minuta nakon prve injekcije kako bi se produljilo pojačanje kontrasta.
Before administering the product, it must be activated by using the Vialmix, a mechanical shaking device.
Prije primjene lijek se mora aktivirati korištenjem Vialmixa, uređaja za mehaničko miješanje.
After activation (shaking), do not store above 30°C.
Nakon aktivacije (miješanja) ne čuvati na temperaturi iznad 30°C.
Each ml contains maximum 6.4 x 109 perflutren-containing lipid microspheres with a mean diameter range of 1.1-2.5 μm (approximately 150 microlitres perflutren gas per ml).
Svaki ml sadrži najviše 6,4 x 109 lipidnih mikrosfera koje sadrže perflutren sa srednjim promjerom u rasponu od 1,1-2,5 μm (otprilike 150 mikrolitara plina perflutrena po ml).
Talk to your doctor before using Luminity - if you have been told you have a heart shunt - if you have severe heart or lung diseases or if you need mechanical help to breathe - if you have an artificial valve in your heart - if you have an acute severe inflammation/sepsis - if you have known hyperactive coagulation system (blood clotting issues) or recurrent thromboembolism (blood clots) - if you have a liver disease - if you have a kidney disease
Obratite se svom liječniku prije primjene Luminityja - ako Vam je rečeno da imate srčani spoj (šant) - ako imate tešku bolest srca ili pluća ili ako Vam je potrebna mehanička pomoć da biste disali
Package leaflet: Information for the user Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion perflutren
Uputa o lijeku: Informacije za korisnika Luminity 150 mikrolitara/ml plin i otapalo za disperziju za injekciju/infuziju perflutren
Elderly Pharmacokinetics has not been specifically studied in the elderly.
Starije osobe Farmakokinetika nije posebno ispitivana u starijih bolesnika.
Luminity is an ultrasound contrast-enhancing agent for use in adult 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.
2 komore najmanje dva od šest segmenata stijenke klijetke nisu mogla ocijeniti) i kod kojih je utvrđena bolest koronarnih arterija ili se sumnja na nju, kako bi omogućio opacifikaciju srčanih komora i bolje ocrtavanje endokardijalne granice lijeve klijetke pri mirovanju i pod opterećenjem.
Pharmacotherapeutic group: ultrasound contrast media, microspheres of phospholipids, ATC Code: V08DA04
5.1 Farmakodinamička svojstva Farmakoterapijska skupina: ultrazvučno kontrastno sredstvo, mikrosfere fosfolipida,
Gas and solvent for dispersion for injection/infusion 1 x 1.5 ml single-dose vial 4 x 1.5 ml single-dose vials
1 x 1,5 ml jednodozna bočica 4 x 1,5 ml jednodozne bočice
Each ml contains a maximum of 6.4 x 109 perflutren-containing lipid bubbles, with an average diameter range of 1.1-2.5 micrometres.
Svaki ml sadrži najviše 6,4 x 109 lipidnih mjehurića koji sadrže perflutren, s prosječnim promjerom u rasponu od 1,1-2,5 mikrometara.
Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion perflutren
Luminity 150 mikrolitara/ml plin i otapalo za disperziju za injekciju/infuziju perflutren
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 noncontrast echocardiography is not optimal.
(začepljenjem krvnih žila koje opskrbljuju srčani mišić) ili sumnjom na takvu bolest, kada slika dobivena nekontrastnom ehokardiografijom nije optimalna.
Nervous system disorders Common: Headache
Poremećaji živčanog sustava Često: glavobolja Manje često: omaglica, disgeuzija
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-3phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE) Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate heptahydrate Sodium chloride
1,2-dipalmitoil-sn-glicero-3-fosfatidilkolin (DPPC) 1,2-dipalmitoil-sn-glicero-3-fosfatidilna kiselina, mononatrijeva sol (DPPA) N-(metoksipolietilenglikol 5000 karbamoil)-1,2-dipalmitoil-sn-glicero-3fosfatidiletanolamin, mononatrijeva sol (MPEG5000 DPPE) natrijev dihidrogenfosfat hidrat natrijev hidrogenfosfat heptahidrat natrijev klorid propilenglikol glicerol voda za injekcije
Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion
Luminity 150 mikrolitara/ml plin i otapalo za disperziju za injekciju/infuziju
Intravenous use Read the package leaflet before use.
NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
The recommended dose via an intravenous infusion is 1.3 ml dispersion added to 50 ml of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection.
Preporučena doza putem intravenske infuzije je 1,3 ml disperzije koja se dodaje u 50 ml 9 mg/ml (0,9%) otopine natrijevog klorida ili 50 mg/ml (5%) otopine glukoze za injekciju.
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 (μm).
Svaki ml sadrži najviše 6,4 x 109 lipidnih mikrosfera koje sadrže perflutren, sa srednjim promjerom u rasponu od 1,1-2,5 mikrometara (μm).
Luminity is then given into a vein either as a ‘bolus' injection (given all at once) or as an infusion (drip solution) after being diluted with sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection.
Luminity se zatim daje u venu bilo kao ‘bolus' injekcija (koja se daje odjednom) ili kao infuzija (otopina za kapanje) nakon razrjeđivanja s 9 mg/ml (0,9%) otopinom natrijevog klorida ili 50 mg/ml
- Luminity may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection.
- Luminity se može razrijediti s 9 mg/ml (0,9%) otopinom natrijevog klorida za injekciju ili 50 mg/ml (5%) otopinom glukoze za injekciju.
Rare: Dyspepsia Not known: Tongue disorder
Nepoznato: poremećaj jezika
Excipients: 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
Pomoćne tvari: 1,2-dipalmitoil-sn-glicero-3-fosfatidilkolin (DPPC), 1,2-dipalmitoil-sn-glicero-3fosfatidilna kiselina, mononatrijeva sol (DPPA), N-(metoksipolietilenglikol 5000 karbamoil)-1,2-dipalmitoil-sn-glicero-3fosfatidiletanolamin, mononatrijeva sol (MPEG5000 DPPE), natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat heptahidrat, natrijev klorid, propilenglikol, glicerol, voda za injekcije
Luminity has not been specifically studied in elderly patients.
Stariji bolesnici Luminity nije posebno ispitivan u starijih bolesnika.
Luminity has not been specifically studied in patients with hepatic impairment.
Luminity nije posebno ispitivan u bolesnika s oštećenjem bubrega.
Store in a refrigerator (2°C - 8°C) For storage conditions after activation of the medicinal product, see section 6.3.
Čuvati u hladnjaku (2°C - 8°C)
Uncommon: Pruritus, increased sweating Rare: Rash, urticaria, erythema, erythematous rash
Rijetko: osip, urtikarija, eritem, eritematozni osip
Rare: Respiratory Distress, Cough, Dry Throat Not known: Respiratory arrest, decreased oxygenation, hypoxia, Gastrointestinal disorders Uncommon: Abdominal Pain, diarrhoea, nausea, vomiting,
Rijetko: respiratorni distres, kašalj, suho grlo Nepoznato: respiratorni arest, smanjena oksigenacija, hipoksija
Do not use Luminity after the expiry date which is stated on the carton and label after EXP. Before activation (shaking), store in a refrigerator (2°C - 8°C).
Prije aktivacije (miješanja) čuvati u hladnjaku (2°C - 8°C).
The product consists of lipid encapsulated perflutren microspheres.
ATK oznaka: V08DA04 Proizvod se sastoji od mikrosfera perflutrena inkapsuliranih lipidom.
• abdominal pain, diarrhoea, nausea (feeling sick), vomiting,
• poteškoće s disanjem, nadražaj grla, • bol u trbuhu, proljev, mučnina, povraćanje,
• breathing problems, cough, dry throat, difficulty in swallowing,
• periferna hladnoća, • tegobe s disanjem, kašalj, suho grlo, poteškoće s gutanjem,
- The other ingredients are 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1,2dipalmitoyl-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 and water for injections.
- fosfatidilna kiselina, mononatrijeva sol (DPPA), N-(metoksipolietilenglikol 5000 karbamoil)-1,2dipalmitoil-sn-glicero-3-fosfatidiletanolamin, mononatrijeva sol (MPEG5000 DPPE), natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat heptahidrat, natrijev klorid, propilenglikol, glicerol i voda za injekcije.
Patients with Cardiac Shunts
Bolesnici sa srčanim spojevima (šantovima)
• numbness of the face,
• oticanje oka,
Hepatic impairment Pharmacokinetics has not been specifically studied in the hepatic disease patients.
Oštećenje jetre Farmakokinetika nije posebno ispitivana u bolesnika s bolešću jetre.
Gas and solvent for dispersion for injection/infusion Colourless, uniformly clear to translucent liquid.
Bezbojna, jednolično bistra do prozirna tekućina.