qanastek/EMEA-V3 huggingface dataset:
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.
Fi studji dwar l- iżvilupp tal - embriju/ fetu li saru fuq ġrieden u firien b’ dożi ta ’ mill- anqas 860 darba jew 1700 darba rispettivament aktar minn dik mogħtija lill- persuni, kien hemm każi ta ’ abort, iżda mhux effetti fuq l- iżvilupp.
These doses resulted in systemic exposures of at least 33- or 97-times higher, respectively, than the intended human exposure.
Dawn id- dożi rriżultaw f’ espożizzjonijiet sistemiċi ta ’ mill- anqas 33 - jew 97 - darba aktar, rispettivament, mill- espożizzjoni rakkomandata għall- persuni.
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).
Fi studji fuq firien qabel it- welid u wara t- twelid, it - tossiċità materna wasslet għal tnaqqis tal- perjodu ta ’ ġestazzjoni, mewt tal- fetu, u tnaqqis fil- piż tal - frieħ ta ’ ≥0. 3 mg/ kg/ ġurnata (mill- inqas 41- darba aktar mill- espożizzjoni intiża għall- persuni).
Neurobehavioural functions of offspring were not affected.
Il - funzjonijiet newroloġiċi ta ’ l- imġieba tal- frieħ ma kienux milquta.
Benzalkonium chloride Sodium chloride Sodium phosphate dibasic heptahydrate Citric acid monohydrate Hydrochloric acid or sodium hydroxide (to adjust pH) Purified water
Benzalkonium chloride Sodium chloride Sodium phosphate dibasic heptahydrate Citric acid monohydrate Hydrochloric acid jew Sodium hydroxide (biex tadatta l- pH) Ilma purifikat
Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.
Kienet murija stabilita ’ kimika u fiżika waqt l- użu għal 28 ġurnata f’ temperatura ta ’ 25ºC.
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.
Min aspett mikrobioloġiku, il- perjodu u l- kundizzjonijiet tal- ħazna waqt l- użu huma responsabbilita ’ ta ’ min qed jużah u ġeneralment ma jkunux ta ’ aktar minn 28 ġurnata f’ temperatura ta 25ºC.
This medicinal product does not require any special storage conditions.
Dan il- prodott medicinali ma jinħtieg ebda kundizzjonijiet speċjali għall- ħazna.
White opaque low density polyethylene bottles with polystyrene screw cap.
Fliexken bojod u opaki ta ’ polyethylene ta’ densità baxxa b’ għatu ta ’ polystyrene tal- kamin.
6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema.
MARKETING AUTHORISATION NUMBER
NUMRU TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ.
8 March 2002 / 20 February 2007
8 ta ’ Marzu 2002 / 20 ta 'Frar 2007
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUG TAL - LOTT
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUG TAL- LOTT
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur responsabbli għall- ħrug tal- lott.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZAZZJONI GĦAT- TQEGĦID FIS - SUQ.
Medicinal product subject to medical prescription.
Prodott medicinali jingħata bir- ricetta tat- tabib.
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING, AND ON THE IMMEDIATE PACKAGING
12 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
LUMIGAN 0.3 mg/ ml, eye drops, solution
LUMIGAN 0. 3 mg/ ml, qtar għall- għajnejn, soluzzjoni
One ml of solution contains 0.3 mg bimatoprost
Ml wiehed fih 0. 3mg Bimatoprost
Benzalkonium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water
Benzalkonium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid jew sodium hydroxide (biex tadatta l- pH) u ilma purifikat
Eye drops, solution 1 x 3 ml
Qtar għall- għajnejn, soluzzjoni 1 x 3 ml
Remove contact lenses before use.
Neħħi l- lentijiet tal- kuntatt qabel ma tużah.
EXP Discard four weeks after first opening.
Armih erba ’ ġimgħat wara li tiftħu l- ewwel darba.
There are no special storage instructions.
M ’ hemm l’ ebda istruzzjonijiet għal ħażna speċjali
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING, AND ON THE IMMEDIATE PACKAGING
14 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Benzalkonium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water
Benzalkonium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid jew sodium hydroxide (biex tadatta l- pH) u ilma purifikat.
Eye drops, solution 3 x 3 ml
Qtar għall- għajnejn, soluzzjoni 3 x 3ml
EXP Discard four weeks after first opening.
Armi erba ’ ġimgħat wara li tiftħu għall- ewwel darba.
Opened (1):
Infetaħ (1):
There are no special storage instructions
M ’ hemm l’ ebda istruzzjonijiet għal ħażna speċjali
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TATAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
LUMIGAN 0.3 mg/ ml, eye drops, solution Bimatoprost Ocular use
LUMIGAN 0. 3 mg/ ml, qtar għall- għajn, soluzzjoni Bimatoprost Użu għall- għajnejn.
Discard 4 weeks after first opening Exp:
JIS:
OTHER
OHRAJN
LUMIGAN 0.3 mg/ ml, eye drops, solution bimatoprost
LUMIGAN 0. 3 mg/ ml qtar għall- għajnejn, soluzzjoni bimatoprost
Do not pass it on to others.
TGĦATIHIEX lil persuni oħra.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
What LUMIGAN is and what it is used for 2.
X’ inhu LUMIGAN u għalxiex jintuża 2.
Before you use LUMIGAN 3.
Qabel ma tuża LUMIGAN 3.
How to use LUMIGAN 4.
Kif għandek tuża LUMIGAN 4.
How to store LUMIGAN 6.
Kif taħżen LUMIGAN 6.
WHAT LUMIGAN IS AND WHAT IT IS USED FOR
X’ INHU LUMIGAN U GĦALXIEX JINTUŻA
LUMIGAN is an antiglaucoma preparation.
LUMIGAN hu prodott mediċinali għal kontra l- glawkoma.
It belongs to a group of medicines called prostamides.
Jifforma parti minn grupp ta ’ mediċini magħrufa bħala prostamidi.
LUMIGAN eye drops are used to reduce high pressure in the eye.
Il- qtar għall- għajnejn LUMIGAN jintużaw biex inaqqsu l- pressjoni għolja fl- għajn.
This high pressure can lead to a disease called glaucoma.
Il- pressjoni għolja tista ’ twassal għal marda magħrufa bħala glawkoma.
If the high pressure is not reduced, it could eventually damage your sight.
Jekk il- pressjoni għolja ma tinżilx, din tista ’ eventwalment tkun ta ’ dannu għall- vista tiegħek.
If the liquid cannot drain out quickly enough, the pressure inside the eye builds up.
Jekk il- likwidu ma joħroġx malajr biżżejjed, tiżdied il- pressjoni fuq il- parti ta ’ ġewwa ta ’ l- għajn.
LUMIGAN works by increasing the amount of liquid that is drained.
LUMIGAN jaħdem billi jżid l- ammont ta ’ likwidu li jitneħħa.
LUMIGAN may be used on its own or with other drops called beta-blockers which also reduce pressure.
LUMIGAN jista ’ jintuża waħdu jew ma qtar ieħor magħrufin bħala imblokkaturi tar- riċetturi beta li wkoll inaqqsu l- pressjoni.
BEFORE YOU USE LUMIGAN
QABEL MA TUŻA LUMIGAN
Do not use LUMIGAN:
Tużax LUMIGAN
- if you are allergic (hypersensitive) to bimatoprost or any of the other ingredients of LUMIGAN.
- Jekk int allerġiku (tbagħti minn sensittivita ’ eċċessiva) għal bimatoprost jew is- sustanzi oħra ta ’
Take special care with LUMIGAN:
Oqgħod attent ħafna b’ LUMIGAN
- Talk to your doctor, if:
- Kellem lit- tabib tiegħek jekk:
- - -
- Għandek xi problemi biex tieħu n- nifs.
You have any breathing problems.
- Għandek xi problemi fil- fwied jew fil- kliewi.
You have had a cataract surgery in the past
- Għamilt l- operazzjoni tal- katarretta fil- passat.
LUMIGAN may cause your eyelashes to darken and grow, and cause the skin around the eyelid to darken too.
19 LUMIGAN jista ’ jikkawża skurament u żjieda fit- tul tax- xagħar ta ’ xfar il- għajn u kif ukoll skurament tal- ġilda tal- kappell ta ’ l- għajn.
The change may be more noticeable if you are only treating one eye.
Il- bidla tista ’ tkun aktar evidenti meta l- kura ssir fuq għajn waħda biss.
People under 18 must not use LUMIGAN.
Persuni taħt it- 18- il sena m’ għandhomx jużaw LUMIGAN.
19 Using other medicines:
Meta tuża mediċini oħra:
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, even those not prescribed.
Jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
If you use LUMIGAN with another eye drop, leave at least five minutes between putting in LUMIGAN and then the other drops.
Jekk tuża LUMIGAN flimkien ma ’ mediċini oħra ta ’ l- għajnejn, ħalli mill- anqas 5 minuti bejn l- użu ta ’ LUMIGAN u l- mediċina l- oħra.
Pregnancy Ask your doctor or pharmacist for advice before taking any medicine.
Tqala Itlob għall- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
LUMIGAN should not be used during pregnancy unless your doctor still recommends it.
LUMIGAN m’ għandux jintuża waqt it- tqala ħlief f’ każijiet fejn it- tabib tiegħek xorta waħda jirrakkomandalek l- użu tiegħu.
Breast-feeding LUMIGAN may get into breast milk so you should not breast-feed while you are taking LUMIGAN.
Jekk qed tredda LUMIGAN jista ’ jidħol fil- ħalib tas- sider u għalhekk m’ għandekx tredda ’ waqt li qed tuża LUMIGAN.
Your sight may become blurred for a short time just after using LUMIGAN.
Il- vista tiegħek tista ’ ssir ftit imċajpra għal ftit ħin hekk kif tuża LUMIGAN.
You should not drive or use machines until your sight is clear again.
M’ għandekx issuq jew tħaddem xi magni qabel ma terġa ’ tiċċaralek il- vista.
Important information about some of the ingredients of LUMIGAN Do not use the drops when you are wearing your lenses.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ LUMIGAN Tużax il- qtar waqt li tkun liebes il- lentijiet tal- kuntatt.
Wait 15 minutes after using the drops before you put your lenses back in.
Stenna mqar 15- il minuta wara li tkun użajt qtar ta ’ l- għajnejn qabel ma terġa ’ tqiegħed il- lentijiet tal- kuntatt lura f’ għajnejk.
A preservative in LUMIGAN called benzalkonium chloride may cause eye irritation and can discolour soft contact lenses.
Preservattiv f’ LUMIGAN magħruf bħala benzalkonium chloride jista ’ jikkawża l- irritazzjoni ta ’ l- għajn u jista ’ jneħħi l- kulur tal- lentijiet tal- kuntatt rotob.
HOW TO USE LUMIGAN
KIF GĦANDEK TUŻA LUMIGAN
LUMIGAN should only be applied to the eye.
LUMIGAN għandu jintuża biss fl- għajn.
Always use LUMIGAN exactly as your doctor has told you.
Dejjem għandek tuża LUMIGAN skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew l- ispiżjar tiegħek jekk ikollok xi dubju. Id- doża li ssoltu tingħata hija qatra waħda ta ’ Lumigan f’ kull għajn li teħtieġ il- kura, darba kuljum, filgħaxija, skond l - istruzzjonijiet għall- użu ta ’ hawn taħt.
Instructions for use:
20 Istruzzjonijiet għall- użu:
You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.
M’ għandekx tuża l- flixkun jekk is- siġill ta ’ sigurtà fl- għonq tal- flixkun ikun miksur qabel ma tkun bdejt tużah għall- ewwel darba.
If a drop misses your eye, try again.
Jekk xi qatra ma tidħolx f’ għajnejk, erġa ’ pprova.
To help prevent infections, do not let the tip of the bottle touch your eye or anything else.
Biex tevita kontaminazzjoni, tħallix il- parti ta ’ fuq tal- flixkun tmiss m’ għajnejk jew ma ’ x’ imkien ieħor.
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.
Jekk tuża LUMIGAN aktar milli suppost, mhux suppost li għandu jikkaġunalek xi danni serji.
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.
Jekk tinsa tuża LUMIGAN Jekk tinsa tuża LUMIGAN, qattar qatra waħda hekk kif tiftakar, imbagħad erġa ’ dur għar- rutina regolari tiegħek.
If you stop using LUMIGAN LUMIGAN should be used every day to work properly.
Jekk tieqaf tuża LUMIGAN LUMIGAN għandu jintuza kuljum biex jaħdem kif suppost.
Like all medicines, LUMIGAN can have side effects, although not everybody gets them.
Bħall kull mediċina oħra, LUMIGAN jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Most of the side effects are not serious.
Il- parti l- kbira ta ’ dawn l- effetti oħra mhumiex serji.
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)
Effetti sekondarji komuni ħafna Dawn jistgħu jolqtu aktar minn persuna waħda fost kull 10 Effett fuq l- għajn • Żjieda fit- tul tax- xagħar ta ’ xfar il- għajn (sa 45% tal- persuni) • Ħmura ħafifa (sa 44% tal- persuni) • Ħakk (sa 14% tal- persuni)
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
Effett fuq l- għajn • Reazzjoni allerġika fl- għajn • Għejja fl- għajnejn • Sensittività għad- dawl • Skurament tal- ġilda madwar l- għajn • Skurament tax- xagħar ta ’ xfar il- għajn • Uġigħ • Sensazzjoni li hemm xi ħaġa f’ għajnejk • Għajnejn iwaħħlu • Skurament tal- ħabba ta ’ l- għajn • Diffikultajiet fil- vista • Irritazzjoni • Ħruq • Infjamazzjoni, ħmura u ħakk fit- teqbet il- għajn • Dmugħ • Nixfa • Infieħ tas- saff trasparenti li jkopri l- wiċċ ta ’ l- għajn • Kataretti • Qasmiet żgħar fil- wiċċ ta ’ l- għajn, b’ infjamazzjoni jew mingħajrha
Affecting the body • Headaches • An increase in blood-test results that show how your liver is working • Increased blood pressure
Effetti fuq il- ġisem • Uġigħ ta ’ ras • Żjieda fir- riżultati ta ’ eżamijiet tad- demm li juru kif qed jaħdem il- fwied tiegħek • Żjieda fil- pressjoni tad- demm
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
Effetti sekondarji mhux komuni Dawn jistgħu jolqtu sa 9 persuni fost kull 1000 Effetti fuq l- għajn • Edema makulari fiċ- ċistojde (infiħ tar- retina fl- għajn li jwassal għat- tnaqqis fil- vista) • Infjamazzjoni fl- għajn • Emorraġġija retinali
If any of the side effects get serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE LUMIGAN
KIF TAĦŻEN LUMIGAN
Do not use LUMIGAN after the expiry date which is stated on the bottle label and the carton after EXP:.
Tużax LUMIGAN wara d- data ta ’ skadenza li tidher fuq it- tiketta tal- flixkun u fuq il- kaxxa wara JIS:.
You must throw away the bottle four weeks after you first opened it, even if there are still some drops left.
Għandek tarmi l- flixkun wara erba ’ ġimgħat li tkun ftaħtu għall- ewwel darba, anke jekk ikun għad fadal xi soluzzjoni.
This will prevent infections.
Dan jevita l- infezzjonijiet.
To help you remember, write down the date you opened it in the space on the box.
Biex ma tinsiex, ikteb id- data ta ’ meta tkun ftaħtu fl - ispazju ta ’ fuq il- kaxxa.
Keep the container tightly closed to prevent contamination
Żomm il- kontenitur magħluq sew biex tevita l- kontaminazzjoni.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu ghal protezzjoni ta ’ l- ambjent.
What LUMIGAN contains
X’ fih LUMIGAN
- The active substance is bimatoprost 0.3 mg/ ml.
- Is- sustanza attiva hi bimatoprost 0. 3mg/ ml.
- The other ingredients are benzalkonium chloride (preservative), sodium chloride, sodium
- Is- sustanzi l- oħra huma benzalkonium chloride (preservattiv), sodium chloride, sodium phosphate
phosphate dibasic heptahydrate, citric acid monohydrate and purified water.
dibasic heptahydrate, citric acid monohydrate u ilma purifikat.
Small amounts of hydrochloric acid or sodium hydroxide may be added to keep the level of acid (pH levels) normal.
Ammonti żgħar ta ’ hydrochloric acid jew sodium hydroxide jistgħu jkunu miżjuda biex iġibu s- soluzzjoni fil- livell korrett ta ’ pH.
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 hu soluzzjoni ta ’ qtar għall- għajnejn mingħajr kulur, li jinsab f’ pakketti li fihom 1 flixkun tal- plastik jew 3 fliexken tal- plastik kull wieħed b’ għatu tal- kamin.
Each bottle is approximately half full and contains 3 millilitres of solution.
Kull flixkun fih bejn wieħed u ieħor 3 millilitri ta ’ soluzzjoni.
This is enough for 4 weeks’ usage.
Dan hu biżżejjed għall- użu fuq 4 ġimgħat.
Not all pack sizes may be marketed.
Jista jkun li mhux il - pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
For any information about this medicine, please contact the local representative of the marketing authorisation holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu /
What is Luminity?
X’ inhu Luminity?
Luminity is a solution for injection or infusion (drip into a vein) that contains microspheres (tiny bubbles) of perflutren gas as the active substance.
Luminity huwa soluzzjoni għal injezzjoni jew infużjoni (dripp fil- vina) li fiha mikrosferi (bżieżaq ċkejkna) ta ’ perflutren gass bħala sustanza attiva.
What is Luminity used for?
Għal xiex jintuża Luminity?
Luminity is for diagnostic use only.
Luminity jintuża eslussivament għal użu dijanjostiku.
It is a contrast agent (a medicine that helps to make internal body structures visible during imaging tests).
Huwa aġent ta ’ kuntrast (mediċina li tgħin biex l- istrutturi interni tal- ġisem ikunu iktar viżibbli fit- testijiet għall- immaġni).
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).
Luminity jintuża biex tinkiseb immaġini iktar ċara tal- kmamar tal- qalb, partikolarment tal- ventrikolu tax- xellug, matul ekokardjografija (test dijanjostiku li bih tinkiseb immaġini tal- qalb bl- użu tal - ultrasound).
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.
Luminity jintuża f’ pazjenti li jbatu minn marda tal- arterja koronarja, suspetta jew konfermata (ostruzzjoni [sadd] tal- arterji u tal- vini li jfornu l- muskolu kardijaku), meta l- immaġini miksuba permezz ta ’ ekokardjografija mingħajr mezz ta ’ kuntrast mhijiex minn tal- aħjar.
How is Luminity used?
Kif jintuża Luminity?
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.
Luminity għandu jingħata minn tobba mħarrġa fit- twettiq u l- interpretazzjoni ta ’ immaġini bl - ekokardjografija b’ kuntrast, fi sptarijiet u kliniki fejn huwa disponibbli tagħmir ta ’ risuxxitazzjoni adegwat f’ każ ta ’ reazzjonijiet allerġiċi.
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.
Qabel l- użu, il- mediċina għandha tiġi attivita b’ tagħmir mekkaniku li jħawwat imsejjaħ Vialmix fornut lit- tobba li jeħtieġu jippreparaw 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.
Dan jiggarantixxi li l- mediċina titħallat korrettament u għal perjodu ta ’ żmien biżżejjed twil biex tinkiseb “ dispersjoni ” tal- mikrosferi ta ’ perflutren gass tad- daqs mixtieq biex tinkiseb immaġini ta ’ kwalità tajba.
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.
Il- mediċina mbagħad tingħata mill- vina f’ forma ta ’ injezzjoni ‘ bolus ’ (l- injezzjoni tingħata kollha f’ daqqa), jew f’ forma ta ’ infużjoni wara li tiġi dilwita b’ dilwent adegwat.
The way Luminity is given and the dose depend on the technique used for the echocardiography.
Il- mod kif jingħta Luminity u d- dożi jiddependu mit- teknika użata fl - ekokardjografija.
Luminity has not been studied in patients with liver or kidney problems, or in the elderly.
Luminity ma ġiex studjat f’ pazjenti li jbatu minn problemi tal- kliewi jew tal- fwied, jew fl- anzjani.
For full details, see the Summary of Product Characteristics (also part of the EPAR).
Għad- dettalji kollha, ara s- Sommarju tal- Karatteristiċi tal- Prodott (parti wkoll mill- EPAR).
How does Luminity work?
Kif jaħdem Luminity?
Before activation, Luminity contains a gas, perflutren, and a solution of fatty substances called phospholipids.
Qabe l- attivazzjoni, Luminity fih gass, perflutren, u soluzzjoni ta ’ sustanzi xaħmin li jisimhom fosfolipidi.
After activation, the medicine contains microspheres of perflutren gas in a fatty layer of phospholipids.
Wara l- attivazzjoni, il- mediċina fiha mikrosferi ta ’ perfluten gass f’ saff xaħmi ta ’ fosfolipidi.
Perflutren microspheres are used as a contrast agent in echocardiography because, when using ultrasound, they generate echoes very differently from the surrounding tissues.
Fl- ekokardjografija, il- mikrosferi ta ’ perflutren jintużaw bħala aġent ta ’ kuntrast billi, meta
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. jintuża l- ultrasound, dawn jiġġeneraw eki differenti ħafna mit- tessuti ta ’ madwarhom.
Luminity is injected, it travels in the veins to the heart.
Wara l - injezzjoni, Luminity jiċċirkola fil- vini lejn il- qalb.
This helps to obtain a better contrast between the area where the gas bubbles are (such as the heart chambers) and the surrounding tissue during the echocardiography.
Matul l- ekokardjografija, dan jgħin biex jinkiseb kuntrast aħjar bejn iż- żona li fiha jinsabu l- bżieżaq ta ’ gass (bħall- kmamar tal- qalb) u t- tessut ta ’ madwarha.
The gas is then cleared through the lungs.
Il- gass jinħeles mill- pulmuni.
How has Luminity been studied?
Kif ġie studjat Luminity?
The effects of Luminity were first tested in experimental models before being studied in humans.
L- effetti ta ’ Luminity ġew ittestjati għall- ewwel darba b’ mudelli sperimentali qabel ma ġew studjati fuq il- bniedem.
There were five main studies of the effectiveness of Luminity, involving a total of 401 patients.
Twettqu ħames studji ewlenin fuq l- effikaċja ta ’ Luminity, li involvew total ta ’ 401 pazjent.
Three studies looked at its effectiveness in enhancing the image of the left ventricle, comparing the echocardiography scan before and after administration of Luminity.
Tliet studji eżaminaw l- effikaċja tiegħu fit- titjib tal- immaġini tal- ventrikolu tax- xellug, meta mqabbla mal - immaġini ekokardjografika qabel u wara l- għoti ta ’ Luminity.
In two of these studies, Luminity was compared with placebo (a dummy treatment).
F’ żewġ studji fost dawn, Luminity tqabbel ma ’ plaċebo (trattament finta).
The last two studies were set up primarily to look at the effectiveness of Luminity in improving the accuracy of the measurement of the ejection fraction (the percentage of the blood volume that is pumped out of the heart in one beat).
L- aħħar żewġ studj twettqu primarjament biex jeżaminaw l - effikaċja ta ’ Luminity fit- titjib tal- preċiżjoni tal- kejl tal- frazzjoni ta ’ tfigħ ‘ il barra (ejection fraction, il- perċentwal tal- volum ta ’ demm ippumpjat ‘ il barra mill- qalb ma ’ kull taħbita).
These studies also looked at left ventricle image enhancement.
Dawn l- istudji eżaminaw ukoll it- titjib tal- immaġini tal- ventrikolu tax- xellug.
What benefit has Luminity shown during the studies?
Liema benefiċċju wera Luminity waqt l- istudji mwettqa?
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.
Luminity kien effikaċi fit- titjib tal- immaġini tal- ventrikolu tax- xellug u rriżulta iktar effikaċi mill - plaċebo fl- istudji li fihom Luminity tqabbel mal- plaċebo.
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’.
Billi l- ħames studji kollha twettqu b’ teknika magħrufa bħala ultrasound imaging ‘ fundamentali ’, il- kumpanija ppreżentat ukoll l- eżiti ta ’ xi studji li wrew li r- riżultati miksuba bl- imaging fundamentali setgħu jinkisbu wkoll b’ tekniki ta ’ imaging magħrufa bħala ‘ armoniċi ’ u ‘ mhux lineari ’.
What is the risk associated with Luminity?
X’ inhu r- riskju assoċjat ma ’ Luminity?
The most common side effects with Luminity (seen in between 1 and 10 patients in 100) are headache and flushing (reddening of the skin).
L- effetti sekondarji l- aktar komuni b’ Luminity (li dehru f’ madwar 1 sa 10 pazjenti minn 100) huma wġigħ ta ’ ras u ħmura fil- ġilda.
Patients can also develop a severe allergic reaction to Luminity, and must be closely monitored.
Il- pazjenti jistgħu wkoll jiżviluppaw reazzjoni allerġika gravi għal Luminity u għandhom jiġu sorveljati bir- reqqa.
For the full list of all side effects reported with Luminity, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrapportati b’ Luminity, ara l- Fuljett ta ’ Tagħrif.
Luminity should not be used in people who may be hypersensitive (allergic) to perflutren or any of the other ingredients.
Luminity ma għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal perflutren jew għal xi sustanza oħra tiegħu.
Why has Luminity been approved?
Għaliex ġie approvat Luminity?
The Committee for Medicinal Products for Human Use (CHMP) decided that Luminity’ s benefits are greater than its risks for use as an ultrasound contrast-enhancing agent in echocardiography.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Luminity huma ikbar mir- riskji tiegħu biex jintuża bħala aġent għat- titjib tal- kuntrast bl- użu tal - ultrasound fl- ekokardjografija.
The Committee recommended that Luminity be given marketing authorisation.
Il- Kumitat irrakkomanda li Luminity jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Other information about Luminity:
Aktar tagħrif dwar Luminity:
The European Commission granted a marketing authorisation valid throughout the European Union for Luminity to Bristol-Myers Squibb Pharma Belgium Sprl on 20 September 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Luminity lil Bristol- Myers Squibb Pharma Belgium Sprl fl- 20 ta ’ Settembru 2006.
The full EPAR for Luminity can be found here.
L- EPAR sħiħ għal Luminity jista ’ jiġi konsultat hawn.
This summary was last updated in 12-2008.
Dan is- sommarju kien aġġornat l- aħħar fi:
EMEA Number
Għamla
150 microl itres/ ml
150 mikrolitri/ ml
Solution for dispersion for injection or infusion
Soluzzjoni għal taħlita għal injezzjoni jew infużjoni
4 vials
4 kunjetti
Luminity 150 microlitres/ ml solution for dispersion for injection or infusion
Luminity 150 mikrolitri/ ml soluzzjoni għal taħlita għal injezzjoni jew infużjoni
Each ml contains a maximum of 6.4 x 109 perflutren-containing lipid microspheres, with a mean diameter range of 1.1-2.5 micrometres (μ m).
Kull ml fih massimu ta ’ 6. 4 x 109 mikrosferi lipidi li fihom perflutren, b’ dijametru medju li jvarja bejn 1. 1- 2. 5 mikrometri (μm).
The approximate amount of perflutren gas in each ml is 150 microlitres (μ l).
L- ammont approssimattiv ta ’ gass ta ’ perflutren f’ kull ml huwa 150 mikrolitri (μl).
Sodium 2.679 mg per ml
Sodju 2. 679 mg għal kull ml
Colourless, uniformly clear to translucent liquid.
Likwidu bla kulur, ċar għal trasluċidu b’ mod uniformi.
This medicinal product is for diagnostic use only.
Dan il- prodott mediċinali huwa għal użu dijanjostiku biss.
Luminity is an ultrasound contrast-enhancing agent for use in patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.
Luminity huwa sustanza li tkabbar il- kuntrast ta ’ l- ultrasound sabiex jintuża f’ pazjenti li fihom, l - ekukardjografija mhux kontrastanti kienet subottimali (subottimali hija kkunsidrata li tindika li mill - inqas tnejn mis- sitt segmenti fir- 4 - jew fit - 2- chamber view tal- ħajt ventrikulari ma kinux valutabbli) u li huma ssuspettati jew diġà ġie stabbilit, li għandhom mard ta ’ l- arterji koronarji, sabiex jipprovdi opaċifikazzjoni tal- kavitajiet kardijaċi u titjib tad- delineazzjoni tal- ħajt endokardijaku ventrikulari tax - xellug kemm matul il- mistrieħ kif ukoll waqt stress.
Luminity should only be administered by trained physicians with technical expertise in performing and interpreting contrast echocardiograms, and appropriate resuscitation equipment should be available in case of hypersensitivity reactions.
Luminity għandu jingħata biss minn tobba mħarrġa li għandhom ħila teknika fit- twettiq u fl - interpretazzjoni ta ’ ekukardjogrammi ta ’ kuntrast, u fil- każ ta ’ reazzjonijiet ta ’ sensittività eċċessiva għandu jkun hemm apparat ta ’ risuxxitazzjoni disponibbli.
Before administering Luminity, the product must be activated by using a mechanical shaking device, the Vialmix (see section 6.6).
Qabel ma jingħata Luminity, il- prodott għandu jiġi attivat billi jintuża apparat mekkaniku li jħawwad, il- Vialmix (ara sezzjoni 6. 6).
This product should only be administered intravenously.
Dan il- prodott għandu jingħata biss minn ġol- vina.
Bolus intravenous injection using non-linear contrast imaging technique at rest and stress:
Injezzjoni ta ’ bolus ġol- vina bl- użu ta ’ teknika ta ’ immaġni ta ’ kuntrast mhux lineari waqt il- mistrieħ u waqt stress:
The recommended dose is multiple injections of 0.1 to 0.4 ml, followed by a 3 to 5 ml bolus of sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection to maintain optimal contrast enhancement.
Id- doża rakkomandata hija injezzjonijiet multipli ta ’ 0. 1 sa 0. 4 ml, segwita b’ bolus ta ’ 3 sa 5 ml ta ’ soluzzjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride jew ta ’ 50 mg/ ml (5%) ta ’ glukosju għal injezzjoni sabiex jinżamm l- aqwa titjib fil- kuntrast.
The total dose should not exceed 1.6 ml.
Id- doża totali m’ għandhiex taqbeż 1. 6 ml.
Bolus intravenous injection using fundamental imaging technique at rest:
2 Injezzjoni ta ’ bolus ġol- vina bl- użu ta ’ teknika ta ’ immaġni fundamentali waqt il- mistrieħ:
The recommended dose is 10 microlitre dispersion/ kg by slow bolus intravenous injection, followed by a 10 ml bolus of sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection.
Id- doża rakkomandata hija taħlita ta ’ 10 mikrolitri/ kg b’ injezzjoni tal- bolus bil- mod ġol- vina, segwita b’ 10 ml ta ’ bolus ta ’ soluzzjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride jew ta ’ 50 mg/ ml (5%) ta ’ glukosju għal injezzjoni.
2 If necessary, a second 10 microlitre dispersion/ kg dose followed by a second 10 ml bolus of sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection may be administered 5 minutes after the first injection to prolong contrast enhancement.
Jekk ikun meħtieġ, doża oħra ta ’ taħlita ta ’ 10 mikrolitri/ kg segwita b’ tieni bolus ta ’ 10 ml ta ’ soluzzjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride jew ta ’ 50 mg/ ml (5%) ta ’ glukosju tista ’ tingħata 5 minuti wara l- ewwel injezzjoni biex jiġi mtawwal it- titjib fil- kuntrast.
Intravenous infusion using non-linear contrast imaging technique (rest and stress) or fundamental imaging technique at rest:
Infużjoni ġol- vina bl- użu tat- teknika ta ’ immaġni ta ’ kuntrast mhux lineari (mistrieħ u stress) jew bit - teknika ta ’ immaġni fundamentali waqt il- mistrieħ:
The recommended dose is via an intravenous infusion of 1.3 ml added to 50 ml of sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection.
Id- doża rakkomandata hija permezz ta ’ infużjoni ġol- vina ta ’ 1. 3 ml miżjuda ma ’ 50 ml ta ’ soluzzjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride jew ta ’ 50 mg/ ml (5%) ta ’ glukosju għal injezzjoni.
The rate of infusion should be initiated at 4.0 ml/ minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 ml/ minute.
Ir- rata ta ’ l- infużjoni għandha tinbeda b’ 4. 0 ml/ minuta, iżda dożata kif meħtieġ sabiex jinkiseb l- aħjar titjib ta ’ l - immaġni, biex ma taqbiżx 10 ml/ minuta.
Luminity should not be used with fundamental imaging technique for stress echocardiography since efficacy and safety have not been established.
Luminity m’ għandux jintuża mat- teknika ta ’ immaġni fundamentali għal ekukardjografija ta ’ l- istress billi l- effikaċja u s- sigurtà ma ġewx stabbiliti.
Children and Adolescents:
Tfal u Adoloxxenti:
Luminity should not be used in patients below 18 years as efficacy and safety in these groups have not been established.
Luminity m’ għandux jintuża f’ pazjenti taħt it- 18- il sena billi l- effikaċja u s - sigurtà f’ dawn il- gruppi għadhom ma ġewx stabbiliti.
Patients with hepatic impairment:
Pazjenti b’ indeboliment tal- fwied:
Luminity has not been specifically studied in patients with hepatic impairment.
Luminity ma ġiex studjat speċifikament f’ pazjenti b’ indeboliment tal- fwied
Patients with renal impairment:
Pazjenti b’ indeboliment tal- kliewi:
Luminity has not been specifically studied in patients with renal impairment.
Luminity ma ġiex studjat speċifikament f’ pazjenti b’ indeboliment tal- kliewi
Elderly Patients:
Pazjenti Anzjani:
Luminity has not been specifically studied in elderly patients.
Luminity ma ġiex studjat speċifikament f’ pazjenti anzjani
Hypersensitivity to perflutren or to any of the excipients.
Sensittività eċċessiva għas- sustanza( i) attiva( i) jew għal xi sustanzi mhux attivi.
The safety of Luminity in patients with right-to-left, bi-directional or transient right-to-left cardiac shunts has not been studied.
Is- sigurtà ta ’ Luminity f’ pazjenti b’ mogħdijiet (shunts) kardijaċi mil- lemin għax- xellug, bidirezzjonali jew mil- lemin għax- xellug temporanji għadha ma ġietx studjata.
In these patients, phospholipid encapsulated microspheres can bypass the lung and directly enter the arterial circulation.
F’ dawn il- pazjenti, mikrosferi fosfolipidi inkapsulati jistgħu jaqbżu l- pulmun u jidħlu direttament fiċ- ċirkolazzjoni arterjali.
Caution must be exercised when considering the administration of Luminity to these patients (see section 5.3).
Trid tittieħed kawtela meta jiġi kkunsidrat l- għoti ta ’ Luminity lil dawn il- pazjenti (ara sezzjoni 5. 3).
The safety of microspheres in patients on mechanical ventilation has not been established.
Is- sigurtà tal- mikrosferi f’ pazjenti fuq ventilazzjoni mekkanika ma ġietx stabbilita.
Caution should be exercised when considering the administration of Luminity to these patients.
Trid tittieħed kawtela meta jiġi kkunsidrat l- għoti ta ’ Luminity lil dawn il- pazjenti.
Other methods of administration not specified in section 4.2 (e. g. intra-arterial injection) are not recommended.
Metodi oħra ta ’ għoti mhux speċifikati f’ sezzjoni 4. 2 (eż. injezzjoni fl- arterji) m’ humiex rakkomandati.
If Luminity is administered directly to the patient without undergoing the mechanical activation procedure using the Vialmix (see section 6.6), the product will not produce its intended effect.
Jekk Luminity jingħata direttament lill- pazjent mingħajr ma titwettaq il- proċedura ta ’ l- attivazzjoni mekkanika bl- użu ta ’ Vialmix (ara sezzjoni 6. 6), il- prodott ma jipproduċix l- effett maħsub tiegħu.
Caution should be exercised in patients with clinically significant pulmonary disease, including diffuse interstitial pulmonary fibrosis and severe chronic obstructive pulmonary disease, as no studies have been performed in these patients.
Trid tittieħed kawtela f’ pazjenti b’ mard pulmonari klinikament sinifikanti, inkluż fibrożi pulmonari mxerrda ta ’ l- interstizju u mard kroniku sever ta ’ mblokk tal- pulmuni, billi ma twettqux studji fuq dawn il- pazjenti.
As experience is limited in patients with certain severe states of cardiac and pulmonary diseases, Luminity should be used only after careful consideration and such use should be monitored closely during administration.
Dawn il- kondizzjonijiet jinkludu s- sindrome tat- tbatija
These states include adult respiratory distress syndrome, severe heart failure (NYHA IV), endocarditis, acute myocardial infarction with on-going angina or unstable angina, hearts with prosthetic valves, acute states of systemic inflammation or sepsis, known states of hyperactive coagulation system and/ or recurrent thromboembolism.
3 respiratorja adulta, attakki tal- qalb severi (NYHA IV), endokardite, infart mijokardjali akut b’ anġina kontinwa jew anġina instabbli, qlub b’ valvi prostetiċi, kondizzjonijiet akuti ta ’ infjammazzjoni sistemika jew sepsis, kondizzjonijiet magħrufa ta ’ sistema ta ’ koagulazzjoni attiva żżejjed u/ jew tromboemboliżmu rikorrenti.
3 Serious immediate hypersensitivity reactions (eg: anaphylaxis, anaphylactic shock and anaphylactoid reactions, hypotension and angioedema) have been reported following the administration of Luminity.
Wara l- għoti ta ’ Luminity, ġew irrapportati reazzjonijiet ta ’ sensittività eċċessiva immedjati (eż: anafilassi, xokk anafilattiku u reazzjonijiet anafilaktojde, pressjoni baxxa u anġjoedema).
Patients should be closely monitored and administration should be under the direction of a physician experienced in the management of hypersensitivity reactions including severe allergic reactions, which might require resuscitation.
Il- pazjenti għandhom jiġu immonitorjati mill- qrib u l- għoti għandu jsir taħt id- direzzjoni ta ’ tabib b’ esperjenza fil- ġestjoni ta ’ reazzjonijiet ta ’ sensittività eċċessiva inkluż reazzjonijiet allerġiċi severi, li jistgħu jeħtieġu risuxxitazzjoni.
Emergency equipment and personnel trained in its use must be readily available.
Għandu jkun hemm disponibbli apparat ta ’ emerġenza u personal imħarreġ fl - użu tiegħu.
No interaction studies have been performed and no other forms of interaction have been identified.
Ma sarux studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott u ma ġiet identifikata ebda forma oħra ta ’ interazzjoni.
For perflutren, no clinical data on exposed pregnancies are available.
Għal perflutren m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Studji fuq il- bhejjem ma jurux effetti ħżiena diretti jew indiretti fuq it- tqala, fuq l- iżvilupp ta ’ l- embriju/ fetu, ħlas jew żvilupp wara t - twelid (ara 5. 3).
It is not known whether Luminity is excreted in human breast milk.
Mhux magħruf jekk Luminity joħroġx fil- ħalib tas- sider uman.
Therefore, caution should be exercised when Luminity is administered to breast-feeding women.
Għalhekk, għandha tittieħed kawtela meta Luminity jingħata lil nisa li jkunu qegħdin ireddgħu.
As Luminity has no pharmacologic effect, and on the basis of its pharmacokinetic and pharmacodynamic profiles, no or negligible influence is expected with the use of this product on the ability to drive or use machines.
Billi Luminity m’ għandu l- ebda effett farmakoloġiku, u fuq il- bażi tal- profili farmakokinetiċi u farmakodinamiċi tiegħu, ma hija mistennija l- ebda influwenza fuq il- ħila biex issuq u tħaddem magni jew inkella hija mistennija biss influwenza negliġibbli bl- użu ta ’ dan il- prodott.
The reported adverse reactions following the use of Luminity in pivotal and supportive trials (total of 2,526 patients) have generally been mild to moderate in intensity, occur within minutes after administration and usually resolve without therapeutic intervention within 15 minutes.
Ir- reazzjonijiet avversi rrapportati wara l- użu ta ’ Luminity fi provi prinċipali u ta ’ sostenn (total ta ’ 2, 526 pazjent) ġeneralment kienu ħfief għal moderati fl- intensità, iseħħu fi żmien ftit minuti wara li jingħata u ġeneralment jitilqu mingħajr intervent terapewtiku fi żmien 15- il minuta.
The most frequently reported adverse reactions are: headache (2.0%), flushing (1.0%) and back pain (0.9%).
L- aktar reazzjonijiet avversi rrapportati ta ’ sikwit huma: uġigħ ta ’ ras (2. 0%), fwawar (1. 0%) u wġigħ fid - dahar (0. 9%).
In clinical trials with Luminity, adverse reactions were reported with the following frequencies (Very common ≥ 1/ 10; Common ≥ 1/ 100, < 1/ 10; Uncommon ≥ 1/ 1,000, < 1/ 100; Rare ≥ 1/ 10,000, < 1/ 1,000; Very rare < 1/ 10,000).
Fi provi kliniċi b’ Luminity, kienu rrapportati reazzjonijiet avversi bil- frekwenzi li ġejjin (Komuni ħafna ≥ 1/ 10; Komuni ≥ 1/ 100, < 1/ 10; Mhux komuni ≥ 1/ 1, 000, < 1/ 100; Rari ≥ 1/ 10, 000, < 1/ 1, 000; Rari ħafna < 1/ 10, 000).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is - serjetà tagħhom, blaktar serji jitniżżlu l- ewwel.
Investigations Cardiac disorders Nervous system disorders
4 Investigazzjonijiet Disturbi fil- qalb Disturbi fis- sistema nervuża
Abnormal Electrocardiogram Rare:
Elektrokardjogramma Anormali Rari:
Bradycardia, Tachycardia, Palpitations Common:
Bradikardija, Takikardija, Palpitazzjonijiet Komuni:
Dizziness, Dysgeusia Rare:
Sturdament, Diżgewżja Rari:
Paraesthesia
Paraesteżija
Dyspnoea, Throat Irritation Rare:
Dispnea, Irritazzjoni tal- Gerżuma Rari:
Respiratory Distress, Cough, Dry Throat Uncommon:
Tbatija Respiratorja, Sogħla, Gerżuma Xotta Mhux komuni:
Abdominal Pain, Diarrhoea, Nausea, Vomiting Rare:
Uġigħ Addominali, Dijarea, Nawsja, Rimettar Rari:
Dyspepsia
Dispepsja
Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders Vascular disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Disturbi muskolu- skeltrali u tal- connective tissue
Pruritus, Increased Sweating Rare:
Ħakk tal- Ġilda, Żieda fl- Ammont ta ’ Għaraq Rari:
Rash, Urticaria, Erythema, Erythematous Rash Uncommon:
Raxx, Urtikarja, Eritema, Raxx Eritamatiku Mhux komuni:
Back Pain Rare:
Uġigħ fid- dahar Rari:
Arthralgia, Flank Pain, Neck Pain, Muscle Cramp Common:
Artralġja, Uġigħ fil- Ġnub, Uġigħ fl- Għonq, Bugħawwieġ fil- Muskoli
Flushing Uncommon:
Komuni:
Hypotension Rare:
Fwawar Mhux komuni:
Syncope, Hypertension, Peripheral Coldness
Sinkope, Pressjoni għolja, Kesħa fl- Estremitajiet
Chest Pain, Fatigue, Feeling Hot, Injection site Pain 4 Rare:
Uġigħ fis- Sider, Għeja, Sensazzjoni ta ’ Sħana, Uġigħ fil- post fejn tingħata l- injezzjoni Rari:
Pyrexia, Rigors
Deni, Rogħda ta ’ bard
The following additional adverse reactions have been reported during post– marketing experience; they are derived from spontaneous reports and therefore, the frequency of these adverse reactions is not known:
Ir- reazzjonijiet avversi addizzjonali li ġejjin ġew irrapportati matul esperjenza ta ’ wara t- tqegħid fis - suq; huma miksubin minn rapporti spontanji u għalhekk, il- frekwenza ta ’ dawn ir- reazzjonijiet avversi m’ hijiex magħrufa:
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.
Reazzjonijiet tat- tip allerġiku (eż: anafilassi, xokk anafilattiku u reazzjonijiet anafilaktojde, pressjoni baxxa u anġjoedema) (ara sezzjoni 4. 4) Reazzjonijiet tas- sistema nervuża ċentrali (inkluż attakki ta ’ puplesija u reazzjonijiet simili għall- attakki tal- puplesija), li jistgħu jkunu assoċjati ma ’ reazzjonijiet ta ’ sensittività eċċessiva immedjati Spasmi muskolari, uġigħu skumdità muskuloskeletali, u mijalġja.
The clinical consequences of overdosing with Luminity are not known.
Il- konsegwenzi kliniċi ta ’ doża eċċessiva ta ’ Luminity mhumiex magħrufa.
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.
Dożi singoli ta ’ taħlita li fiha sa 100 µl għal kull kg u dożi multipli ta ’ taħlit li fihom sa 150 µl għal kull kg kienu ttollerati sewwa fil- provi kliniċi ta ’ l- Ewwel Fażi.
Treatment of an overdose should be directed towards the support of all vital functions and prompt institution of symptomatic therapy.
It- trattament ta ’ doża eċċessiva għandu jkun dirett lejn is - sostenn tal- funzjonijiet vitali kollha u l- introduzzjoni immedjata ta ’ terapija sintomatika.
Pharmacotherapeutic group: ultrasound contrast media, microspheres of phospholipids, ATC Code:
Kategorija farmakoterapewtika: mezzi ta ’ kuntrast ta ’ l- ultrasound, mikrosferi fosfolipidi, Kodiċi ATC:
The product consists of lipid encapsulated perflutren microspheres.
Il- prodott huwa magħmul minn mikrosferi ta ’ perflutren inkapsulati fil- lipidi.
Microspheres in the 1 to < 10 µm diameter size range contribute to the contrast effect by generating strongly enhanced echoes.
Il- mikrosferi li d - dijametru tagħhom ivarja bejn 1 u < 10 µm jikkontribwixxu għall- effett ta ’ kuntrast billi jiġġeneraw eki amplifikati sewwa.
The ultrasound echoes from blood and biological soft tissues such as fat and muscles are generated at interfaces due to small differences in the ultrasonic properties of the tissues.
L- eki ta ’ l- ultrasound mid- demm u t- tessuti bijoloġiċi rotob bħax- xaħam u l- muskoli huma ġġenerati f’ postijiet komuni minħabba differenzi żgħar fil- kwalitajiet ultrasoniċi tat- tessuti.
The ultrasonic properties of the product are very different from those of soft tissue and will generate strong echoes.
Il- kwalitajiet ultrasoniċi tal- prodott huma differenti ħafna minn dawk tat- tessut artab u jiġġeneraw eki b’ saħħithom.
As Luminity consists of microspheres that are stable and small enough for transpulmonary passage, enhanced echo signals in the left heart and systemic circulation are obtained.
Billi Luminity huwa magħmul minn mikrosferi li huma stabbli u żgħar biżżejjed għal passaġġ transpulmonari, jinkisbu sinjali aħjar ta ’ l- eku fin- naħa tax- xellug tal- qalb u fiċ- ċirkolazzjoni sistemika.