natgillin/translations-raw huggingface dataset:
Reaktioner fra centralnervesystemet (inklusive kramper og krampelignende reaktioner), som kan være forbundet med øjeblikkelige overfølsomhedsreaktioner Muskelspasmer, smerter og ubehag i knogler og muskler, samt myalgi.
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.
De kliniske konsekvenser af overdosis af Luminity kendes ikke.
The clinical consequences of overdosing with Luminity are not known.
Enkeltdoser på op til 100 µl dispersion/ kg og gentagne doser på op til 150 µl dispersion/ kg har været veltolerede i kliniske Fase I forsøg.
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.
Farmakoterapeutisk klassifikation: ultralydskontraststof, mikrosfærer af fosfolipider ATC- kode:
Pharmacotherapeutic group: ultrasound contrast media, microspheres of phospholipids, ATC Code:
Mikrosfærer i størrelsesordenen 1 til < 10 µm diameter bidrager til kontrasteffekten ved at generere meget forstærkede ekkoer.
Microspheres in the 1 to < 10 µm diameter size range contribute to the contrast effect by generating strongly enhanced echoes.
Selvom det er påvist, at højere doser producerer en længerevarendee kontrasteffekt, kan et præcist dosis- responsforhold ikke defineres.
A strict dose/ response relationship cannot be defined, although higher doses have been shown to produce a contrast effect of longer duration.
Luminitys farmakokinetiske egenskaber er undersøgt hos raske frivillige og patienter med kronisk obstruktiv lungesygdom (KOL) efter intravenøs administration af en dosis på 50 µl/ kg.
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.
Luminitys perflutren- bestanddel clearedes hurtigt fra det systemiske kredsløb via lungerne.
The perflutren component of Luminity was rapidly cleared from the systemic circulation via the lungs.
50% af den administrerede dosis.
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.
Hos de fleste patienter kunne perflutren ikke spores i blodet eller ekspirationsluften efter 4- 5 minutter.
In most subjects after 4-5 minutes, perflutren was undetectable in blood and expired air.
Koncentrationer af perflutren i blodet vistes at falde mono - eksponentielt med en gennemsnitlig halveringstid på 1, 3 minutter hos raske frivillige og 1, 9 minutter hos KOL- patienter.
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.
Den systemiske clearance af perflutren var ensartet hos raske frivillige og KOL - patienter.
The systemic clearance of perflutren was similar in healthy and COPD subjects.
Total lunge- clearance (CLlung) af perflutren vistes ikke at være anderledes hos raske frivillige end hos KOL- patienter.
Total lung clearance (CLlung) of perflutren was shown to be no different in healthy subjects compared to COPD subjects.
CLlung fandtes at være betydeligt reduceret (51%) hos kvinder sammenlignet med mænd (alle patienter).
CLlung was found to be significantly reduced (51%) in females compared to males (all subjects).
Disse resultater tyder på, at den overordnede systemisk elimination af perflutren er hurtig og ikke betydeligt reduceret hos KOL- patienter sammenlignet med raske frivillige.
These results suggest that overall perflutren systemic elimination is rapid and is not significantly reduced in COPD patients compared to healthy subjects.
Der er udført Doppler- ultralydsmålinger med Luminity i forbindelse med den farmakokinetiske evaluering af perflutren.
Doppler ultrasound measurements were performed with Luminity in conjunction with the pharmacokinetic evaluation of
5 vistes at svare til perflutren blod, tmax (1, 13 versus 1, 77 minutter).
5 perflutren.
Det observerede fald på 99% i intensitet i Doppler- signal inden for 10 minutter (t1/ 2 ca.
Doppler signal intensity corresponded well with measured and extrapolated perflutren concentrations in blood.
2 minutter) var i overensstemmelse med faldet i målelige blodniveauer af perflutren.
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.
Der er i kliniske forsøg med Luminity anvendt almindelige grundlæggende og non- lineære billedteknikker (second harmonic, multipuls- fase og/ eller amplitudemodulation) med såvel vedvarende som udløst acquisition
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.
6. 1) fordeles i de endogene lipiddepoter i kroppen (fx leveren), hvorimod den syntetiske komponent (MPEG5000) i kliniske forsøg er vist at udskilles gennem urinen.
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.
Nyresygdom:
Renal Disease:
Leversygdom:
Hepatic Disease:
De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af genotoksicitet, fertilitet, embryo - / føtaludvikling, fødsel eller post- natal udvikling samt lokal tolerance.
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.
Der er i toksicitetsforsøg med enkeltdoser og gentagne doser på ≥ 0, 3 ml/ kg til rotter og aber set abnorm vejrtrækning, ændringer i hjertefrekvens samt nedsat aktivitet umiddelbart efter intravenøs injektion af Luminity.
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.
Højere doser, typisk ≥ 1 ml/ kg, resulterede i sværere tegn, inklusiv passivitet og i visse tilfælde død.
Higher doses of the product, typically ≥ 1 ml/ kg, resulted in more severe signs including unresponsiveness and occasionally death.
1, 2- dipalmitoyl- sn- glycero- 3- phosphatidylcholin (DPPC) 1, 2- dipalmitoyl- sn- glycero- 3- phosphatidsyre, mononatriumsalt (DPPA) N - (methoxypolyethylenglycol 5000 carbamoyl) - 1, 2- dipalmitoyl- sn- glycero- 3- phosphatidylethanolamin, mononatriumsalt (MPEG5000 DPPE) Natriumdihydrogenphosphat monohydrat Dinatrium hydrogenphosphatheptahydrat Natriumchlorid Propylenglycol Glycerol Vand til injektionsvæsker
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
6 6. 2 Uforligeligheder
6.2 Incompatibilities
6. 3 Opbevaringstid
6 6.3 Shelf life
Inden aktivering:
Before activation:
Efter aktivering:
After activation:
12 timer.
12 hours.
Opbevares i køleskab (2°C – 8°C) Efter aktivering:
Store in a refrigerator (2°C - 8°C) After activation:
Klart, borosilicat Type I hætteglas, lukket med chlorbutyl elastomerisk lyofiliseringsstopper og forseglet med aluminiumkrave, der trækkes af med plastikknap.
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.
Produktet leveres som 1 x 1, 5 ml eller 4 x 1, 5 ml enkeltdosishætteglas.
The product is supplied as 1 x 1.5 ml or 4 x 1.5 ml single-dose vials.
6. 6 Regler for destruktion og anden håndtering Det er af yderste vigtighed at brugsvejledningen følges ved anvendelse af Luminity, og at aseptiske procedurer overholdes omhyggeligt ved tilberedning.
It is essential to follow instructions for use and handling of Luminity and to adhere to strict aseptic procedures during preparation.
Som alle parenterale produkter, skal hætteglassene gennemses for partikler, og det skal checkes, at de er ubeskadiget.
Like all parenteral products, the vials must be inspected visually for particulates and vial integrity.
Vialmixeren er ikke inkluderet i Luminity- pakken, men leveres til lægen ved bestilling af pakken.
The Vialmix is not included in the Luminity pack but will be provided to healthcare professionals upon ordering the pack.
Vialmixeren vil advare brugeren, hvis rystehastigheden varierer med 5% eller mere under den ønskede hastighed.
The Vialmix will alert the operator if the shaking frequency varies by 5% or more below the target frequency.
Den er også programmeret til at selv at lukke ned, og den vil med lys og lyd advare brugeren, hvis rystehastigheden overskrider den ønskede hastighed med 5% eller falder mere end 10% under den ønskede hastighed.
It also has been programmed to shut down and will provide visual and audio warnings if the shaking frequency exceeds the target frequency by 5%, or falls below the target frequency by 10%.
Umiddelbart efter aktivering vil Luminity
Immediately after activation, Luminity appears as a
fremstå som en mælket, hvid dispersion.
milky white dispersion.
Hætteglasset må ikke opbevares ved over 30°C efter aktivering.
Do not store the vial above 30°C following activation.
- Hætteglasset skal ventileres med steril kanyle eller steril ikke- silikoneret mini- lancet, inden
- The vial should be vented with a sterile syringe needle or a sterile non-siliconised mini-spike before
dispersionen trækkes op.
withdrawing the dispersion.
- Dispersionen skal trækkes op ved hjælp af sprøjte med steril 18- 20 g kanyle eller fastgjort på steril
- The dispersion should be withdrawn from the vial using a syringe with a 18 to 20 gauge sterile
ikke- silikoneret mini- lancet.
needle or attached to a sterile non-siliconised mini-spike.
Der skal må ikke lukkes luft ind i hætteglasset.
No air should be injected into the vial.
- Luminity kan fortyndes med natriumchlorid 9 mg/ ml (0, 9%) opløsning til injektion eller glucose
- Luminity may be diluted with sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose
50 mg/ ml (5%) opløsning til injektion.
50 mg/ ml (5%) solution for injection.
Bristol- Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185 / Terhulpsesteenweg 185 B- 1170 Bruxelles / Brussel Belgien
Bristol-Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185 / Terhulpsesteenweg 185 B-1170 Bruxelles / Brussel Belgium
2. 800 I- 04410 Sermoneta (Latina) Italien
2.800 I-04010 Sermoneta (Latina) Italy
Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilancesystemet, som beskrevet i version 3. 0 i Modul 1. 8. 1 i ansøgningen om markedsføringstilladelse, er på plads og fungerer før og efter produktet er markedsført.
The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
12 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Luminity 150 mikroliter/ ml opløsning til dispersion til injektion eller infusion Perflutren
Luminity 150 microlitres/ ml solution for dispersion for injection or infusion Perflutren
150 μl perflutrengas per ml)
Each ml contains maximum 6.4 x 109 perflutren-containing lipid microspheres with a mean diameter range of 1.1-2.5 μ m (approximately 150 μ l perflutren gas per ml).
1, 2- dipalmitoyl- sn- glycero- 3- phosphatidylcholin (DPPC), 1, 2- dipalmitoyl- sn- glycero- 3- phosphatidsyre, mononatriumsalt (DPPA), N - (methoxypolyethylenglycol 5000 carbamoyl) - 1, 2- dipalmitoyl- sn- glycero- 3- phosphatidylethanolamin, mononatriumsalt (MPEG5000 DPPE), natriumdihydrogenphosphat monohydrat, dinatrium hydrogenphosphatheptahydrat, natriumchlorid, propylenglycol, glycerol, vand til injektionsvæsker
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 x 1, 5 ml enkeltdosis- hætteglas 4 x 1, 5 ml enkeltdosis- hætteglas
1 x 1.5 ml single-dose vial 4 x 1.5 ml single-dose vials
13 Efter aktivering: anvendes inden for 12 timer
EXP After activation: use within 12 hours
Opbevares i køleskab Efter aktiviering:
Store in a refrigerator After activation:
Bristol- Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185 / Terhulpsesteenweg 185 B- 1170 Bruxelles / Brussel Belgien
Bristol-Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185 / Terhulpsesteenweg 185 B-1170 Bruxelles / BrusselBelgium
EU/ 1/ 06/ 361/ 001 4 enkeltdosis- hætteglas EU/ 1/ 06/ 361/ 002 1enkeltdosis- hætteglas
EU/ 1/ 06/ 361/ 001 4 single-dose vials EU/ 1/ 06/ 361/ 002 1 single-dose vial
Da Luminity kun er beregnet til at administreres af sundhedspersonale, vil der ikke blive udarbejdet information i Braille- skrift.
As Luminity is only intended for administration by healthcare professionals no information will be included in Braille.
14 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
14 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Luminity 150 mikroliter/ ml opløsning til dispersion til injektion eller infusion Perflutren Intravenøs anvendelse
Luminity 150 microlitres/ ml solution for dispersion for injection or infusion Perflutren Intravenous use
Læs denne indlægsseddel grundigt inden du begynder at få medicinen.
Read all of this leaflet carefully before you are given this medicine.
Lad derfor være med at give Luminity til andre.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har.
please tell your doctor or pharmacist.
Luminitys virkning og hvad du skal bruge det til 2.
What Luminity is and what it is used for 2.
Det skal du vide, før du begynder at få Luminity 3.
Before you are given Luminity 3.
Sådan gives Luminity 4.
How Luminity is given 4.
Sådan opbevarer du Luminity 6.
How to store Luminity 6.
LUMINITYS VIRKNING OG HVAD DU SKAL BRUGE DET TIL
WHAT LUMINITY IS AND WHAT IT IS USED FOR
Luminity er et kontraststof til ultralydsundersøgelser, som indeholder bittesmå luftbobler.
Luminity is an ultrasound contrast agent that contains tiny gas bubbles.
Det forstærker de billeder, der ses ved en ultralydsundersøgelse, og kan hjælpe lægen med at få et bedre billede (scanning) af hjertet.
It enhances the images seen with ultrasound and helps your doctor to get a clearer picture (scan) of your heart.
DET SKAL DU VIDE, FØR DU BEGYNDER AT FÅ LUMINITY
BEFORE YOU ARE GIVEN LUMINITY
Du må ikke få Luminity
Do not use Luminity
- hvis du er overfølsom (allergisk) over for perflutren eller et af de øvrige indholdsstoffer.
- if you are allergic (hypersensitive) to perflutren or any of the other ingredients of Luminity.
Luminity må ikke bruges til børn eller unge, fordi Luminitys virkning på disse aldersgrupper er ikke undersøgt.
Luminity should not be used in children and adolescents as it has not been studied in these groups.
Hvis du tidligere har haft en allergisk reaction efter at du har fået Luminity eller et andet kontraststof til ultralydsundersøgelser, skal du fortælle det til din læge.
If you have had an allergic reaction in the past with Luminity or any other ultrasound contrast agent tell your doctor.
Vær ekstra forsigtig med Luminity
Take special care with Luminity
- hvis du har fået at vide, at du har en hjerteshunt
- if you have been told you have a heart shunt
- hvis du lider af en svær hjerte - eller lungesygdom
- if you have severe heart or lung diseases
- hvis du har kunstige hjerteklapper
- if you have an artificial valve in your heart
- hvis du har akut inflammation/ blodforgiftning
- if you have acute severe inflammation/ sepsis
- hvis du har hyperaktivt koaguleringssystem / eller tilbagevendende blodpropper
- if you have known hyperactive coagulation system/ or recurrent thromboembolism
- hvis du har en leversygdom
- if you have liver disease
- hvis du har en nyresygdom
- if you have kidney disease
17 Spørg din læge eller apoteket til råds, før du får Luminity.
17 Pregnancy and breast-feeding Tell your doctor if you are pregnant or breast-feeding and ask your doctor or pharmacist for advice before you are given Luminity.
Trafik - og arbejdssikkerhed Evnen til at køre bil og betjene maskiner påvirkes ikke.
Driving and using machines The ability to drive and use machines is not affected.
Vigtig information om nogle af de øvrige indholdsstoffer i Luminity Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. det er næsten ” natriumfrit ”.
Important information about some of the ingredients of Luminity This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially ‘ sodium-free’.
SÅDAN GIVES LUMINITY
HOW LUMINITY IS GIVEN
Dipersionen gives som infusion over en periode (drop), eller gives ufortyndet som intravenøs indsprøjtning (direkte ind i blodåren).
Luminity is for intravenous use and the prepared dispersion is either diluted with sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection and given by infusion over a period of time (drip solution), or given undiluted as an intravenous injection (direct injection into the vein).
Ved ultralydsundersøgelser af hjertet, er den anbefalede dosis gentagne intravenøse indsprøjtninger af 0, 1 til 0, 4 ml Luminity, efterfulgt af en intravenøs indsprøjtning af 3 til 5 ml natriumchlorid 9 mg/ ml (0, 9%) eller glucose 50 mg/ ml (5%) opløsning til injektion.
For heart ultrasound examination, the recommended dose is multiple intravenous injections of 0.1 to 0.4 ml of Luminity, followed by an intravenous injection of 3 to 5 ml sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection.
Den samlede maksimale dosis er 1, 6 ml.
The maximum total dose is 1.6 ml.
Produktet kan også gives i en dosis af 10 mikroliter/ kg ved intravenøs indsprøjtning efterfulgt af en intravenøs indsprøjtning af 10 ml natriumchlorid 9 mg/ ml (0, 9%) eller glucose 50 mg/ ml (5%) opløsning til injektion, afhængigt af hvilken ultralydsteknik lægen har valgt.
The product can also be given at a dose of 10 microlitre/ kg by intravenous injection followed by an intravenous injection of 10 ml sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection, depending on which ultrasound technique your doctor has chosen to use.
I nogle tilfælde kan lægen vælge at bruge to indsprøjtninger for at gennemføre ultralydsundersøgelsen.
In some cases, your doctor may choose to use two injections to complete the ultrasound examination.
Lægen kan også vælge at give 1, 3 ml Luminity gennem en intravenøs infusion sammen med 50 ml natriumchlorid 9 mg/ ml (0, 9%) eller glucose 50 mg/ ml (5%) opløsning til injektion.
Your doctor may also choose to give Luminity 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.
Lægen beslutter hvor hurtigt infusionen skal gives.
Your doctor will decide on the speed at which the infusion should be given.
Hvis du får for meget Luminity Det vides ikke, hvilken effekt en overdosis vil have.
If you are given more Luminity than you should It is not known what the effect of an overdose is.
Luminity kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Luminity can cause side effects, although not everybody gets them.
Almindelige bivirkninger (flere end 1 patient ud af 100, færre end 1 patient ud af 10) Hovedpine, rødme.
Common side effects (greater than 1 patient out of 100, less than 1 patient out of 10) Headache, flushing.
Ualmindelige bivirkninger (flere end 1 patient ud af 1000, færre end 1 patient ud af 100) Svimmelhed, ændret smagssans, lavt blodtryk, vejrtrækningsbesvær, halsirritation, mavesmerter, diarré, kvalme, opkastning, kløe, øget svedtendens, rygsmerter, brystsmerter, voldsom træthed, følelse af varme og smerter ved indsprøjtningsstedet.
Uncommon side effects (greater than 1 patient out of 1,000, less than 1 patient out of 100) Dizziness, altered taste, reduced blood pressure, difficulty in breathing, throat irritation, abdominal pain, diarrhoea, nausea (feeling sick), vomiting, itching, increased sweating, back pain, chest pain, fatigue, feeling hot and pain at the site of injection.
Sjældne bivirkninger (flere end 1 patient ud af 10. 000, færre end 1 patient ud af 1000) Følelsesløshed, prikken eller brænden, ændret hjerteslag, hjertebanken (Dit hjerte banker hårdere eller uregelmæssigt), utilpashed, højt blodtryk, kolde fingre og tæer, vejrtrækningsbesvær, hoste, tør hals, synkebesvær, udslæt, rødme af huden, ledsmerter, sidestik, nakkesmerter, muskelkramper, feber, muskelstivhed og unormalt elektrokardiogram.
Rare side effects (greater than 1 patient out of 10,000, less than 1 patient out of 1,000) Numbness, tingling and or burning sensation, altered heart rate, palpitations (you feel your heart beats harder or in an irregular way), feeling faint, increased blood pressure, peripheral coldness, breathing problems, cough, dry throat, difficulty in swallowing, rash, redness of the skin, joint pain, pain on the side(s), neck pain, muscle cramp, fever, muscle stiffness and abnormal electrocardiogram.
Nogle patienter kan opleve allergilignende reaktioner, som f. eks. hævet ansigt.
18 Some patients may experience allergic type reactions such as swelling of the face.
Der er imidlertidig en risiko for, at disse allergilignende raktioner kan blive alvorlige og kan omfatte anafylaktiske shock.
There is however a risk that these allergic type reactions become severe and may include anaphylactic shock.
18 Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
SÅDAN OBEVARER DU LUMINITY
HOW TO STORE LUMINITY
Brug ikke Luminity efter den udløbsdato, der står på pakningen.
Do not use Luminity after the expiry date which is stated on the carton and label.
Inden aktivering, opbevares i køleskab (2º- 8ºC).
Before activation, store in a refrigerator (2°C - 8°C).
Efter aktivering, må ikke opbevares over 30ºC.
After activation, do not store above 30°C.
Du skal have modtaget dispersionen inden for 12 timer efter aktivering.
The dispersion should be given to you within 12 hours of activation.
Luminity indeholder:
What Luminity contains
Hver ml indeholder højst 6, 4 x 109 perflutren- holdige lipid- bobler, med en gennemsnitlig diameter på 1, 1- 2, 5 mikrometer.
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.
150 mikroliter.
The approximate amount of perflutren gas in each ml of Luminity is 150 microlitres.