qanastek/EMEA-V3 huggingface dataset:
In very rare cases, fatal outcomes have been reported in temporal association with the use of SonoVue.
F’ każijiet rari ħafna, riżultati fatali kienu rrappurtati f’ assoċjazzjoni temporali ma ’ l- użu ta SonoVue.
In all these patients there was a high underlying risk for major cardiac complications, which could have led to the fatal outcome.
F’ dawn il- pazjenti kollha, kien hemm riskju bażiku qawwi għal komplikazzjonijiet kardijaċi maġġuri, li setgħu wasslu għar- riżultat fatali.
Since there have been no cases of overdose reported to date, neither signs nor symptoms of overdose have been identified.
Billi s’ issa ma kien hemm l- ebda każijiet ta ’ doża eċċessiva, ma kienu identifikati la sinjali u lanqas sintomi ta ’ doża eċċessiva.
In a Phase I study doses up to 56 ml of SonoVue were administered to normal volunteers without serious adverse events being reported.
Fi studju ta ’ Fażi I, dożi li sa 56 ml ta ’ SonoVue ingħataw lil voluntiera normali u ma kienu rrappurtat avvenimenti avversi serji.
In the event of overdose occurring, the patient should be observed and treated symptomatically.
Fil- każ ta ’ teħid ta ’ doża eċċessiva, il- pazjent għandu jkun osservat u jingħata l- kura skond is- sintomi li jkun qed juri.
Ultrasound contrast media ATC code:
Mezz tal- kuntrast ta ’ l- ultrasound Kodiċi ATC:
The addition of sodium chloride 9 mg/ ml (0.9%) solution for injection to the lyophilised powder followed by vigorous shaking results in the production of the microbubbles of sulphur hexafluoride.
Iż- żieda ta ’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni mat- trab lyophilisate segwita minn tħawwid bis- saħħa jwassal għall- produzzjoni ta ’ bżieżaq żgħar ta ’ ezaflorinat tal- kubrit..
The microbubbles have a mean diameter of about 2.5 µm, with 90% having a diameter less than 6 µm and 99% having a diameter less than 11 µm.
Il - bżieżaq żgħar għandhom dijametru medju ta ’ madwar 2. 5 µm, b’ 90% li jkollhom dijametru ta ’ inqas minn 6 µm u 99% jkollhom dijametru ta ’ inqas minn 11 µm.
Each millilitre of SonoVue contains 8 µl of the microbubbles.
Kull millilitru ta ’ SonoVue ikun fih 8 µl minn dawn il- bżieżaq żgħar.
The interface between the sulphur hexafluoride bubble and the aqueous medium acts as a reflector of the ultrasound beam thus enhancing blood echogenicity and increasing contrast between the blood and the surrounding tissues.
L- interface bejn il- bużżieqa ta ’ ezaflorinat tal- kubrit. u mezz likwidu jaġixxi bħala riflettur tar- raġġ ta ’ l- ultrasound, u b’ hekk itejjeb l- ekoġeniċità tad- demm u jżid il - kuntrast bejn id- demm u t- tessuti tal- madwar.
The intensity of the reflected signal is dependent on concentration of the microbubbles and frequency of the ultrasound beam.
5 L- intensità tas- sinjal rifless tiddependi mill- konċentrazzjoni tal- bżieżaq u l- frekwenza tar- raġġ ta ’ l - ultrasound.
5 increase in signal intensity of more than 2 minutes for B-mode imaging in echocardiography and of 3 to 8 minutes for Doppler imaging of the macrovasculature and microvasculature.
Fid- dożi kliniċi proposti, intwera li SonoVue jipprovdi żieda ċara fl- intensità tas- sinjal ta ’ iktar minn 2 minuti għall- immaġni tal- B- mode fl- ekokardjografija u ta ’ minn 3 sa 8 minuti għall - immaġni Doppler tal- makrovaskulatura u l- mikrovaskulatura.
Sulphur hexafluoride is an inert, innocuous gas, poorly soluble in aqueous solutions.
ezaflorinat tal- kubrit. hu gass inerti, innokwu, u li jinħall b’ mod mill- aktar ristrett f’ soluzzjonijiet likwidi.
There are literature reports of the use of the gas in the study of respiratory physiology and in pneumatic retinopexy.
Hemm rapporti tal- letteratura dwar l- użu ta ’ dan il- gass fl- istudju tal- fiżjoloġija respiratorja u fir- retinopexy pnewmatika.
The sulphur hexafluoride dissolves in the blood and is subsequently exhaled.
L- ammont totali ta ’ ezaflorinat tal- kubrit. mogħti f’ doża klinika hu estremament żgħir, (f’ doża ta ’ 2 ml, il- bżieżaq żgħar ikun fihom 16 µl ta ’ gass). ezaflorinat tal- kubrit. jinħall fid- demm u eventwalment joħroġ man- nifs.
After a single intravenous injection of 0.03 or 0.3 ml of SonoVue/ kg (approximately 1 and 10 times the maximum clinical dose) to human volunteers, the sulphur hexafluoride was cleared rapidly.
Wara injezzjoni waħda ġol- vina ta ’ 0. 03 jew 0. 3 ml ta ’ SonoVue/ kg (madwar 1 sa 10 darbiet tad- doża klinika massima) lil voluntiera umani, ezaflorinat tal- kubrit. tneħħa malajr.
The mean terminal half-life was 12 minutes (range 2 to 33 minutes).
Il- medja tal- half- life terminali kienet ta ’ 12- il minuta (medda ta ’ bejn 2 u 33 minuta).
More than 80% of the administered sulphur hexafluoride was recovered in exhaled air within 2 minutes after injection and almost 100% after 15 minutes.
Iktar minn 80% ta ’ ezaflorinat tal - kubrit. li ngħata kien irkuprat fl- arja li toħroġ man- nifs sa 2 minuti wara l- injezzjoni, u kważi 100% wara 15 il minuta.
In patients with diffuse interstitial pulmonary fibrosis, the percent of dose recovered in expired air averaged 100% and the terminal half-life was similar to that measured in healthy volunteers.
F’ pazjenti b’ fibrożi pulmonari interstizjali diffuża, il- perċentwal ta ’ doża rkuprata mill- arja li toħroġ man- nifs kellha medja ta ’ 100%, u l- half- life terminali kienet bħal dik imkejla f’ voluntiera f’ saħħithom.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and toxicity to reproduction.
Informazzjoni miġbura qabel l- użu kliniku ma tiżvela l- ebda riskju speċjali għall- bniedem, ibbażat fuq studji konvenzjonali dwar is- sigurtà farmakoloġika, il- ġenotossiċità, u dwar it- tossiċitċa għar - riproduzzjoni.
Caecal lesions observed in some repeat-dose studies with rats, but not in monkeys, are not relevant for humans under normal conditions of administration.
Feriti fil- musrana l- għamja li kienu osservati fi studji dwar id- doża ripetuta fil- firien, iżda mhux fix- xadini, mhumiex rilevanti għall- bnedmin taħt il- kundizzjonijiet normali ta ’ l- għoti.
Sodium chloride 9 mg/ ml (0.9%) solution for injection
Sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni
Once reconstituted, chemical and physical stability has been demonstrated for 6 hours.
Wara li jkun rikostitwit, l- istabbilità kimika u fiżika intweriet għal 6 sigħat.
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user.
Jekk ma jintużax immedjatament, il - ħinijiet u kundizzjonijiet tal- ħażna qabel ma jintuża huma r- responsabbiltà ta ’ min qed jużah.
For storage conditions of the reconstituted medicinal product, see section 6.3.
M’ hemm l- ebda struzzjonijiet għal ħażna speċjali Għall- kundizzjonijiet tal- ħażna tal- prodott mediċinali rikostitwit, ara sezzjoni 6. 3.
25 mg of dry, lyophilised powder in an atmosphere of sulphur hexafluoride in a colourless Type I glass vial, with elastomeric closure.
Preżentazzjoni 02 (b’ sistema tat- trasferiment MiniSpike separata): - 25 mg ta ’ trab xott, lyophilised, f’ atmosfera ta ’ ezaflorinat tal- kubrit., f’ kunjett tal- ħġieġ mingħajr kulur ta ’ Tip I, b’ tapp elastometriku.
Separate transfer system.
Sistema tat- trasferiment separata.
Type I glass pre-filled syringe containing 5 ml sodium chloride 9 mg/ ml (0.9%) solution for injection.
Siringa mimlija għal- lest tal- ħġieġ ta ’ Tip I li fiha 5 ml sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni.
Before use examine the product to ensure that the container and closure have not been damaged.
Qabel tużah, eżamina l- prodott biex tassigura li l- kontenitur u l- għatu tiegħu m’ għandhomx ħsara.
SonoVue must be prepared before use by injecting through the septum 5 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection to the contents of the vial.
SonoVue għandu jiġi ppreparat qabel ma jintuża billi tinjetta minn ġos- septum 5 ml ta ’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni mal- kontenut tal- kunjett.
The vial is then shaken vigorously for twenty seconds after which the desired volume of the dispersion can be drawn into a syringe as follows, depending on the presentation:
Il- kunjett għandu jitħawwad sew għal għoxrin sekonda qabel ma ’ l- volum mixtieq tad- dispersjoni jkun jista ’ jinġibed fis- siringa kif spjegat hawn taħt, skond il- preżentazzjoni:
Presentation 02 (with separate MiniSpike transfer system)
Preżentazzjoni 02 (b’ sistema tat- trasferiment MiniSpike separata)
Connect the plunger rod by screwing it clockwise into the syringe.
Qabbad il- virga tal- planġer billi ddawwarha lejn il- lemin ġos- siringa.
Open the transfer system cap and connect the syringe to the transfer system by screwing it in clockwise.
Iftaħ il- folja tas- sistema tat- trasferiment MiniSpike u neħħi l- għatu tat- tarf tas- siringa.
Remove Flipcap glass protective disk from the vial.
d- diska ta ’ sigurtà Flipcap tal- ħġieġ mill- kunjett.
Slide the vial into the transparent sleeve of the transfer system and press firmly to lock the vial in place.
trasparenti tas- sistema tat- trasferiment u agħfas sew biex issakkar il- kunjett f’ postu.
Empty the contents of the syringe into the vial by pushing on the plunger rod.
Battal il- kontenut tas- siringa fil- kunjett billi timbotta l- virga tal- planġer.
Shake vigorously for 20 seconds to mix all the contents in the vial (white milky liquid).
Ħawwad sew għal 20 sekonda biex tħallat il- kontenut kollu tal- kunjett (likwidu abjad qisu ħalib)
Invert the system and carefully withdraw SonoVue into the syringe.
Aqleb is- sistema rasha ‘ l isfel u iġbed bil- mod SonoVue fis- siringa.
Unscrew the syringe from the transfer system.
Ħoll is- siringa mis- sistema tat- trasferiment.
SonoVue should be administered immediately by injection into a peripheral vein.
SonoVue għandu jingħata immedjatament permezz ta ’ injezzjoni f’ vina perferali.
After reconstitution, a homogeneous white milky liquid is obtained.
Wara r- rikostituzzjoni, jinkiseb likwidu abjad omoġenju qisu ħalib.
If solid parts of the lyophilisate are seen or the suspension is not homogeneous, the product should be discarded.
Jekk ikun hemm partijiet solidi tal - lyophilisate, jew jekk is- suspensjoni ma tkunx omoġenja, il- prodott għandu jintrema.
If SonoVue is not used immediately after reconstitution the microbubble dispersion should be shaken again before being drawn up into a syringe.
Jekk SonoVue ma jintużax immedjatament wara t- taħlita, id- dispersjoni tal- bżieżaq żgħar għandha titħawwad mill - ġdid qabel ma tinġibed f’ siringa.
Chemical and physical stability of the microbubble dispersion has been demonstrated for 6 hours.
L- istabbilità kimika u fiżika ntweriet għal 6 sigħat.
The vial is for a single examination only.
Il- kunjett hu għal eżami wieħed biss.
Any unused dispersion remaining at the end of an examination or waste material must be discarded in accordance with local requirements.
Kwalunkwe dispersjoni mhux użata, jew skart li jibqa ’ fl- aħħar ta ’ eżami, għandu jintrema skond il- liġijiet lokali.
26 March 2001 / 24 April 2006
26 ta ’ Marzu, 2001 / 24 t’ April, 2006
9 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
9 A DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
The MAH will provide a PSUR covering the period 01/ 10/ 2005 to 30/ 09/ 2006 and continue with yearly PSURs unless otherwise agreed with CHMP.
PSURs: Id- Detentur ta ’ l- Awtorizzazzjoni ser tipprovdi PSUR li jkopri l- perjodu minn 01/ 10/ 05 sa 30/ 09/ 06 u jkompli bil- PSURs kull sena ħlief jekk miftiehem mod ieħor mas- CHMP.
Outer label, presentation 02
Tikketta ta ’ barra, preżentazzjoni 02
SonoVue sulphur hexafluoride microbubbles 8 microlitres/ ml Powder and solvent for dispersion for injection
SonoVue ezaflorinat tal- kubrit. bżieżaq żgħar 8 mikrolitri/ ml Trab u solvent għad- dispersjoni għall- injezzjoni
One ml contains 8 µl of sulphur hexafluoride microbubbles
1 ml fih 8 µl ta ’ ezaflorinat tal- kubrit. bżieżaq żgħar
Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol sodium, palmitic acid.
Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol sodium, palmitic acid.
Solvent: sodium chloride 9 mg/ ml (0.9%) solution for injection.
Solvent: sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni.
1 vial containing 25 mg lyophilized powder to be reconstituted with 5 ml sodium chloride 9 mg/ ml (0.9%) solution for injection 1 pre-filled syringe containing sodium chloride 9 mg/ ml (0.9%) solution for injection 1 Mini-Spike Plus 6/ 8 (CE 0123) transfer system.
1 kunjett fih 25 mg ta ’ trab lyophilised li jrid ikun rikostitwit b’ 5 ml ta ’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni 1 siringa mimlija għal- lest li fih sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni 1 Mini- Spike Plus 6/ 8 (CE 0123) sistema ta ’ trasferiment.
1 ml of the reconstituted dispersion contains 8 microlitres sulphur hexafluoride microbubbles.
1 ml tad- dispersjoni rikostitwita fiha 8 mikrolitri ta ’ ezaflorinat tal- kubrit. bżieżaq żgħar.
Intravenous use Read carefully the package leaflet before use.
Użu għal ġol- vini Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Exp:
Jis.
For single use only, discard any unused portion
Għall- użu ta ’ darba biss; armi kwalunkwe porzjon mhux użat
SonoVue 8 microlitres/ ml powder for dispersion for injection
SonoVue 8 microlitri/ ml trab għad- dispersjoni għall- injezzjoni
25 mg lyophilised powder to be reconstituted with 5 ml sodium chloride 9 mg/ ml (0.9%) solution for injection before administration.
25 mg trab lyophilised li jrid ikun rikostitwit b’ 5 ml ta ’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni qabel l- għoti.
Sodium chloride 9 mg/ ml solution for injection
Sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni
For use with SonoVue
Għall- użu ma ’ SonoVue
SonoVue 8 microlitres/ ml powder and solvent for dispersion for injection sulphur hexafluoride
SonoVue 8 microlitri/ ml trab u solvent għad- dispersjoni għall- injezzjoni ezaflorinat tal- kubrit.
Read all of this leaflet carefully before you start using this medicine.
Aqra dan il fuljett kollu qabel tibda tuża din il- mediċina.
If you have further questions, ask your doctor or pharmacist.
Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek.
Do not pass it on to others.
Din il- mediċina ġiet mogħtija għall- użu personali tiegħek u m’ għandekx tagħtiha lil persuni oħra.
What SonoVue is and what it is used for Before you use SonoVue How to use SonoVue Possible side effects How to store SonoVue Further information
X’ inhu SonoVue u għalxiex jintuża Qabel ma tuża SonoVue Kif tuża SonoVue Effetti sekondarji li jista ’ jkollu Kif taħżen SonoVue Aktar tagħrif
WHAT SONOVUE IS AND WHAT IT IS USED FOR
X’ INHU SONOVUE U GĦALXIEX JINTUŻA?
SonoVue is a contrast agent for ultrasound scans of blood vessels and tissues of the body.
SonoVue hu mezz tal- kuntrast għall- skanns permezz ta ’ l- ultrasound ta ’ vini/ arterji tad- demm u tessut tal- ġisem.
SonoVue is a dispersion containing millions of tiny bubbles (microbubbles).
SonoVue hu dispersjoni li fih miljuni ta ’ bżieżaq żgħar ħafna.
Each of these bubbles is smaller than a red blood cell.
Kull waħda minn dawn il- bżieżaq hi iżgħar minn ċellula ħamra tad- demm.
The bubbles act as a reflector of the ultrasound beam and provide a better echo than the tissues of the body.
Dawn il- bżieżaq joħolqu riflessjoni għar- raġġ ta ’ l- ultrasound u jipprovdu eku ta ’ kwalità aħjar mit- tessuti tal- ġisem.
SonoVue is a contrast agent that reflects ultrasound waves differently from the tissues of the body and improves the picture from the scan.
SonoVue jaħdem bħala sustanza tal- kuntrast li jirrifletti r- raġġi ta ’ l- ultrasound b’ mod differenti mit - tessuti tal- ġisem u jtejjeb l- immaġni li mill- iskan.
This helps your doctor to identify the part of your body or blood vessel and to see any abnormalities.
Dan jgħin lit- tabib tiegħek biex jidentifika dik il - parti ta ’ ġismek jew dik l- arterja/ vina biex jara hemmx xi ħaġa li mhix normali.
SonoVue can be used for scans of the chambers of the heart, scans of large blood vessels and scans to assess lesions in the breast and the liver.
SonoVue jista ’ jintuża għal skans tal- kompartimenti tal- qalb, skans ta ’ arterji/ vini kbar u skans biex issir evalwazzjoni ta ’ leżjonijiet fis- sider u fil- fwied.
This medicine is for diagnostic use only.
Dan il- prodott mediċinali hu għall- użu dijanjostiku biss.
BEFORE YOU USE SONOVUE
QABEL MA TUŻA SONOVUE
Do not use SonoVue:
Tużax SonoVue:
If you are allergic (hypersensitive) to sulphur hexafluoride or any of the other ingredients of SonoVue or if you have:
Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal ezaflorinat tal- kubrit. jew sustanzi oħra ta ’ SonoVue; jew jekk għandek:
had a myocardial infarction and you still suffer from frequent and/ or repeated angina or chest pain,
infart mijokardjali u għadek qed tbati minn attakki frekwenti u/ jew ripetuti ta ’ anġina jew uġigħ fis- sider,
had a recent coronary artery intervention, recent changes in your electrocardiogram, frequent and/ or repeated angina or chest pain in the past 7 days, heart failure, severe heart rhythm disorders, right-to-left shunts of the heart, severe increase in pulmonary artery blood pressure, uncontrolled hypertension, adult respiratory distress syndrome.
kellek intervent riċenti fl- arterji koronarji, tibdil riċenti fl- elettrokardjogramm tiegħek, attakki frekwenti u/ jew ripetuti ta ’ anġina jew uġigħ fis- sider fl- aħħar 7 ijiem, attakk kongestiv tal- qalb, mard sever tar- rittmu tal- qalb, mogħdija għaċ- ċirkolazzjoni tad- demm mil- lemin għax- xellug żieda qawwija fil- pressjoni tad- demm fl- arterja pulmonari pressjoni għolja mhux kkontrollata sindrome ta ’ distress respiratorju fl- adulti.
18 If you have had an allergic reaction in the past to SonoVue or any other ultrasound contrast agent tell your doctor.
Jekk kellek xi reazzjoni allerġika fil- passat għal SonoVue jew għal xi sustanza ieħor tal- kuntrast ta ’ l - ultrasound, għid lit- tabib tiegħek.
If you have to undergo echocardiography during stress, tell your doctor if in the past 2 days you have:
18 Jekk kell tagħmel l- ekokardjografija waqt l- istress, għid lit- tabib tiegħek jekk fl- aħħar jumejn int kellek:
had frequent and/ or repeated angina or chest pain, especially if you have history of heart disease,
attakki frekwenti u/ jew ripetuti ta ’ anġina jew uġigħ fis- sider, speċjalment jew għandek storja ta ’ mard tal- qalb.
recent electrocardiography changes.
tibdil riċenti fl- elettrokardjogramm tiegħek.
Take special care with SonoVue:
Oqgħod attent ħafna b’ SonoVue:
-
- matul eżami ekokardjografiku bi stress farmakoloġiku mtejba b’ SonoVue, fejn għandu
during SonoVue-enhanced echocardiography examination with a pharmacological stress, when ECG and blood pressure should be carefully monitored,
jkun hemm monitoraġġ mill- qrib ta ’ l- ECG u l- pressjoni tad- demm.
- -
- f’ każ li għandek mard newroloġiku li hu instabbli, ventilazzjoni respiratorja, endokardite
in case you have severe lung disease and shortage of breath, in case you have a neurological illness which is unstable, respiratory ventilation, acute endocarditis, artificial heart valves, acute systemic inflammation and/ or sepsis, hyperactive coagulation states and/ or recent thromboembolism, advanced kidney or liver diseases.
akuta, valvoli artifiċjali tal- qalb, infjammazzjoni sistemika akuta u/ jew sepsi, stati ta ’ koagulazzjoni iperattiva u/ jew tromboemboliżmu riċenti, mard serju fil- kliewi jew fil - fwied.
Taking other medicines:
Meta tuża ta ’ mediċini oħra:
There are no reports of reactions between SonoVue and other medicines.
M’ hemm l- ebda rapporti ta ’ reazzjonijiet bejn SonoVue u mediċini oħra.
However, please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Madankollu, jekk jogħġbok għid lit- tabib tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki mhux bir- riċetta.
Pregnancy and breast-feeding SonoVue has not been studied in pregnant women.
Tqala u treddigħ Ma sarux studji b’ SonoVue f’ nisa tqal.
Danger to a developing baby is not expected.
Mhux mistenni li jkun hemm periklu fuq tarbija li qed tiżviluppa.
If you are pregnant, or think that you might be pregnant tell your doctor.
Jekk int tqila, jew taħseb li int tqila, informa lit- tabib tiegħek.
If you are breast feeding tell your doctor.
Jekk qed tredda ’ informa lit- tabib tiegħek.
It is not known if SonoVue passes into breast milk.
Mhux magħruf jekk SonoVue jgħaddix fil- ħalib tas- sider.
Your doctor will advise you if you should stop feeding for a short time after your ultrasound examination.
It- tabib tiegħek ser jagħtik parir jekk għandekx tieqaf tredda ’ għal ftit żmien wara l- eżami tiegħek permezz ta ’ l- ultrasound.
HOW TO USE SONOVUE
KIF TUŻA SONOVUE
After reconstitution, SonoVue is a homogeneous white milky dispersion.
Wara r- rikostituzzjoni, SonoVue hu dispersjoni bajda omoġenja, qisha ħalib.
If solid parts are seen or the dispersion is not homogeneous, the product will be discarded.
Jekk ikun hemm partijiet solidi, jew jekk is- suspensjoni ma tkunx omoġenja, il- prodott ser jintrema.
If SonoVue is not used immediately after reconstitution the dispersion will be shaken again before being drawn up into a syringe.
Jekk SonoVue ma jintużax immedjatament wara r- rikostituzzjoni, id- dispersjoni ser tiġi mħawwda mill- ġdid qabel ma tinġibed fis- siringa.
SonoVue is injected into a vein, usually in your arm.
SonoVue jiġi injettat f’ vina, ġeneralment f’ idejk.
The amount that you will be given depends on which part of your body is being scanned.
L- ammont li ser tingħata jiddependi minn liema parti ta ’ ġismek ser tkun skannjata.
The usual dose is 2 or 2.4 ml of the dispersion.
Id- doża normali hi ta ’ 2 jew 2. 4 ml tad- dispersjoni.
This dose might be repeated.
Din id- doża tista ’ terġa ’ tingħata.
The medical staff supervising your scan will administer the injection of SonoVue to you.
L- istaff mediku li jkun qed jieħu ħsieb l- iskann tiegħek ser jagħtuk l- injezzjoni ta ’ SonoVue.
You will be monitored for 30 minutes after your examination.
Id- doża hi l- istess għall- pazjenti adulti u anzjani, madankollu, SonoVue m’ għandux jingħata lil pazjenti taħt it- 18- il sena.
The product is for a single examination only.
Il- prodott jintuża darba biss.
Any unused liquid remaining at the end of an examination must be discarded.
Kwalunkwe likwidu mhux użat li jibqa ’ fl- aħħar ta ’ eżami, għandu jintrema.
If you have any further questions on the use of this product, ask your doctor.
Jekk ikollok aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, jekk jogħġbok staqsi lit- tabib tiegħek.
Like all medicines, SonoVue can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, SonoVue jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
There is a risk of severe allergy-like reactions, including anaphylactic shock.
Jeżisti riskju ta ’ reazzjonijiet li jixbhu lill- allerġija severa, inkluż xokk anafilattiku.
Most of the side effects that have been reported with SonoVue during clinical trials have been mild and were not prolonged.
Il- parti l- kbira ta ’ l- effetti sekondarji li kienu rrappurtati bl- użu ta ’ SonoVue matul il- provi kliniċi kienu ħfief u ma damux ħafna żmien.
The commonly reported side effects include: headache; nausea; pain, burning, bruising or numbness where the injection was given.
L- iktar effetti sekondarji li kienu rrappurati b’ mod komuni jinkludu: uġigħ ta ’ ras; dardir; uġigħ, ħruq, tbenġil jew tmewwit fis- sit ta ’ l- injezzjoni.
19 Side effects less commonly reported include: itching; rash; abdominal, chest or back pain and pain in general; vasodilatation; increase in blood sugar levels; blurred vision; irritation in the throat; sinus pressure; numbness in part of the body; dizziness; difficulty in sleeping; feeling weak; a strange taste.
19 Effetti sekondarji li kienu rrappurtati b’ mod inqas komuni jinkludu: ħakk; raxx; uġigħ ta ’ żaqq, fis - sider jew fid- dahar, u uġigħ ġenerali; vasodilatazzjoni; żieda fil- livelli taz- zokkor fid- demm; vista mċajpra; irritazzjoni fil- gerżuma; pressjoni fis- sinus; tmewwit f’ xi parti tal- ġisem; sturdament; diffikultà fl- irqad; tħossok bla saħħa; togħma stramba.
If you think that you notice any side effects after receiving an injection of SonoVue, tell the medical staff supervising your scan.
Jekk taħseb li qed tinnota xi effetti sekondarji wara li tkun ingħatajt injezzjoni ta ’ SonoVue, informa lill- istaff mediku li qed jieħu ħsieb l- iskann tiegħek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform 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 SONOVUE
KIF TAĦŻEN SONOVUE
Do not use after the expiry date stated on the label.
M’ għandekx tuża wara id- data li jiskadi li tidher fuq it- tikketta.
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali ma jeħtieġ l- ebda kundizzjonijiet speċjali tal- ħażna
SonoVue dispersion should be administered to you within six hours of its preparation.
Id- dispersjoni SonoVue għandha tingħatalek fi żmien sitt sigħat minn x’ ħin tkun ġiet ippreparata.
What SonoVue contains
X’ fih SonoVue
The active substance is sulphur hexafluoride in the form of microbubbles.
Is- sustanza attiva hi ezaflorinat tal- kubrit. taħt is- sura ta ’ bżieżaq żgħar.
The other ingredients are: macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol sodium, palmitic acid.
Is- sustanzi l- oħra huma: macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol sodium, palmitic acid.
The glass syringe contains sodium chloride 9 mg/ ml (0.9%) solution for injection.
Is- siringa tal- ħġieġ fiha sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni.
What SonoVue looks like and content of the pack
Id- dehra ta ’ SonoVue u d- daqs tal- pakkett
SonoVue is a kit which includes a glass vial containing white powder, a glass syringe containing the solvent and a transfer system.
SonoVue hu kitt li jinkludi kunjett tal- ħġieġ li fih trab abjad, siringa tal- ħġieġ li fiha s- solvent u sistema tat- trasferiment.
20 The following information is intended for medical or healthcare professionals only:
20 It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
Presentation 02 (with separate MiniSpike transfer system (CE 0123))
Preżentazzjoni 02 (b’ sistema tat- trasferiment MiniSpike separat (CE0123))
Connect the plunger rod by screwing it clockwise into the syringe.
Qabbad il- virga tal- planġer billi ddawwarha lejn il- lemin ġos- siringa..
Open the MiniSpike transfer system blister and remove syringe tip cap.
Iftaħ il- folja tas- sistema tat- trasferiment MiniSpike u neħħi l- għatu tat- tarf tas- siringa.
Open the transfer system cap and connect the syringe to the transfer system by screwing it in clockwise.
Iftaħ l- għatu tas- sistema tat- trasferiment u qabbad is- siringa mas- sistema tat- trasferiment billi ddawwarha lejn il- lemin.
Remove Flipcap glass protective disk from the vial.
Neħħi d- diska ta ’ sigurtà Flipcap tal- ħġieġ mill- kunjett.
Slide the vial into the transparent sleeve of the transfer system and press firmly to lock the vial in place.
Żerżaq il- kunjett fl- ispazju trasparenti tas- sistema tat- trasferiment u agħfas sew biex issakkar il- kunjett f’ postu.
Shake vigorously for 20 seconds to mix all the contents in the vial (white milky liquid).
Ħawwad sew għal 20 sekonda biex tħallat il- kontenut kollu tal- kunjett (likwidu abjad qisu ħalib).
Unscrew the syringe from the system.
Ħoll is- siringa mis- sistema tat- trasferiment.
What is Sprimeo?
X' inhu Sprimeo?
Sprimeo is a medicine containing the active substance aliskiren.
Sprimeo hu mediċina li fiha s- sustanza attiva aliskiren.
What is Sprimeo used for?
Għal x' hiex jintuża Sprimeo?
Sprimeo is used to treat essential hypertension (high blood pressure). ‘ Essential ’ means that no specific cause for the hypertension can be found.
Sprimeo jintuża fit- trattament tal- pressjoni għolja essenzjali. ‘ Essenzjali 'tfisser li ma tkunx tista' tinstab kawża speċifika għall- pressjoni għolja.
How is Sprimeo used?
Kif jintuża Sprimeo?
The recommended dose of Sprimeo is 150 mg once a day, either taken alone or in combination with other medicines for hypertension.
Id- doża rrakkomandatata ta 'Sprimeo hi 150 mg darba kuljum, jew waħedha jew flimkien ma' mediċini oħra għall- pressjoni għolja.
Sprimeo is not recommended for children, due to a lack of information on safety and effectiveness in this group.
Sprimeo mhux rakkomandat għat- tfal, minħabba nuqqas ta 'tagħrif dwar is- sigurtà u l- effikaċja f' dan il- grupp.
How does Sprimeo work?
Kif jaħdem Sprimeo?
The active substance in Sprimeo, aliskiren, is a renin inhibitor.
Is- sustanza attiva f' Sprimeo, aliskiren, hi inibitur tar- renin.
How has Sprimeo been studied?
Kif ġie studjat Sprimeo?
The effects of Sprimeo were first tested in experimental models before being studied in humans.
L- effetti ta 'Sprimeo għall- ewwel ġew ittestjati f' mudeli esperimentali qabel ma ġew studjati fil - bnedmin.
Sprimeo was studied in 14 main studies involving over 10,000 patients with essential hypertension.
Sprimeo ġie studjat f' 14- il studju ewlieni li fihom ħadu sehem iktar minn 10, 000 pazjent bi pressjoni għolja essenzjali.
In five of the studies, the effects of Sprimeo taken alone were compared with those of placebo (a dummy treatment).
F' ħamsa mill - istudji, l- effetti ta 'Sprimeo meħud waħdu tqabblu ma' dawk ta 'plaċebo (trattament finta).
Sprimeo, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
Sprimeo, meħud waħdu jew flimkien ma 'mediċini oħra, tqabbel ma' mediċini oħra għall- pressjoni għolja.
Combination studies looked at Sprimeo used with an angiotensin converting enzyme inhibitor (ramipril), an angiotensin receptor blocker (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
L - istudji kombinatorji ħarsu lejn l- effett ta 'Sprimeo użat flimkien ma' inibitur ta 'enzim li jikkonverti l - angiotensin (ramipril), ma' sustanza li timblokka r- riċettur ta 'l- angiotensin (valsartan), ma' beta - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
What benefit has Sprimeo shown during the studies?
X' inhu l- benefiċċju ta 'Sprimeo li ntwera f' dawn l- istudji?
Sprimeo on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure.
Sprimeo waħdu kien iktar effettiv mill- plaċebo u kien effettiv daqs it- trattamenti komparattivi fit - tnaqqis tal- pressjoni.
When the results of the five studies comparing Sprimeo taken alone with placebo were looked at together, patients aged under 65 had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Sprimeo, from an average of 99.4 mmHg at the start of the study.
Meta r- riżultati tal- ħames studji li qabblu Sprimeo meħud waħdu ma 'plaċebo ġew studjati flimkien, il- pazjenti li kellhom inqas minn 65 sena kellhom tnaqqis medju fil- pressjoni dijastolika ta' 9. 0 mmHg wara tmien ġimgħat jieħdu 150 mg Sprimeo, minn medja ta '99. 4 mmHg fil - bidu tat- trattament.
Larger falls were seen in patients aged 65 or over and those taking higher doses of Sprimeo.
Fil- pazjenti li kellhom 65 sena jew iktar u f' dawk li kienu qed jieħdu dożi ogħla ta 'Sprimeo kien hemm tnaqqis ikbar fil- pressjoni.
Sprimeo also reduced blood pressure in patients with diabetes, patients who were overweight, and those who were over 65 years of age.
Sprimeo ġab ukoll tnaqqis fil- pressjoni fil - pazjenti bid- dijabete, pazjenti b' piż eċċessiv, u f' dawk li kellhom iktar minn 65 sena.
The studies also showed that Sprimeo, when taken in combination with other medicines (especially hydrochlorothiazide), can produce additional decreases in blood pressure compared with those produced by these medicines taken without Sprimeo.
L- istudji wrew ukoll li Sprimeo, meta meħud flimkien ma 'mediċini oħra (speċjalment hydrochlorothiazide), jista' jwassal għal iktar tnaqqis fil- pressjoni meta mqabbel mat- tnaqqis fil - pressjoni kkawżat minn dawn il- mediċini meħuda mingħajr Sprimeo.
What is the risk associated with Sprimeo?
X' inhu r- riskju assoċjat ma 'Sprimeo?
The most common side effect with Sprimeo (seen in between 1 and 10 patients in 100) is diarrhoea.
L- iktar effett sekondarju komuni ta 'Sprimeo (li deher f' bejn pazjent wieħed u 10 minn kull 100) hi d - dijarea.
For the full list of all side effects reported with Sprimeo, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati ma' Sprimeo, ara l- Fuljett ta 'Tagħrif.
Sprimeo should not be used by people who may be hypersensitive (allergic) to aliskiren or any of the other ingredients.
Sprimeo m' għandux jintuża minn persuni li huma sensittivi żżejjed (allerġiċi) għal aliskiren jew għal xi sustanza oħra tiegħu.
Why has Sprimeo been approved?
Għaliex ġie approvat Sprimeo?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Sprimeo are greater than its risks for the treatment of essential hypertension.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Sprimeo fit- trattament tal- pressjoni għolja essenzjali huma ikbar mir- riskji tiegħu.
The Committee recommended that Sprimeo be given marketing authorisation.
Il- Kumitat irrakkomanda li Sprimeo jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Sprimeo:
Tagħrif ieħor dwar Sprimeo:
The European Commission granted a marketing authorisation valid throughout the European Union for Sprimeo to Novartis Europharm Limited on 22 August 2007.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Sprimeo lil Novartis Europharm Limited fl- 22 ta 'Awwissu ta' l- 2007.
The full EPAR for Sprimeo can be found here.
L- EPAR sħiħ għal Sprimeo jinsab hawn.
Sprimeo 150 mg film-coated tablets
Sprimeo 150 mg pilloli miksijin b’ rita
The recommended dose of Sprimeo is 150 mg once daily.
Id- doża irrikkmandata ta ’ Sprimeo hija 150 mg darba kuljum.
Sprimeo may be used alone or in combination with other antihypertensive agents (see sections 4.4 and 5.1).
Sprimeo jista ’ jintuża waħdu jew ma ’ aġenti oħra li jbaxxu l- pressjoni (ara sezzjonijiet 4. 4 u 5. 1).
Sprimeo should be taken with a light meal once a day, preferably at the same time each day.
Sprimeo għandu jittieħed ma ’ ikla ħafifa darba kuljum, l- aħjar fl- istess ħin tal- ġurnata kuljum.
Grapefruit juice should not be taken together with Sprimeo.
Il - meraq tal- grejpfrut m’ għandux jittieħed flimkien ma ’ Sprimeo.
Paediatric patients (below 18 years) Sprimeo is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).
Pazjenti tfal (taħt it- 18- il sena) Sprimeo mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 2).
In the event of severe and persistent diarrhoea, Sprimeo therapy should be stopped.
F’ każ ta ’ dijarea severa u persistenti, it- terapija b’ Sprimeo għandha titwaqqaf.
Sodium and/ or volume depleted patients In patients with marked volume- and/ or salt-depletion (e. g. those receiving high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Sprimeo.
Pazjenti li għandhom nuqqas ta ’ sodium u/ jew volum F’ pazjenti li jkollhom nuqqas serju ta ’ volum u/ jew melħ (eż dawk li qed jingħataw dożi għoljin ta ’ dijuretiċi) jista ’ jkun hemm sintomi ta ’ pressjoni baxxa wara li tibda l- kura b’ Sprimeo.
This condition should be corrected prior to administration of Sprimeo, or the treatment should start under close medical supervision.
Din il - kundizzjoni għandha tiġi korretta qabel ma jingħata Sprimeo, jew il- kura għandha tinbeda taħt superviżjoni medika stretta.
Renal impairment In clinical studies Sprimeo has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μ mol/ l or 1.70 mg/ dl in women and ≥ 177 μ mol/ l or 2.00 mg/ dl in men and/ or estimated glomerular filtration rate (GFR) < 30 ml/ min), history of dialysis, nephrotic syndrome or renovascular hypertension.
Indeboliment renali Fil- provi kliniċi, Sprimeo ma ġiex investigat f’ pazjenti li għandhom il- pressjoni għolja u li jbatu minn indeboliment renali sever (krejatinina fis- serum ≥ 150 μmol/ l jew 1. 70 mg/ dl fin- nisa u ≥ 177 μmol/ l jew 2. 00 mg/ dl fl- irġiel u/ jew rata ta ’ filtrazzjoni fil- glomeruli (GFR) stmata < 30 ml/ min), li kellhom dijalisi fil- passat, sindrome nefrotika jew pressjoni għolja renovaskulari.
Caution should be exercised in hypertensive patients with severe renal impairment due to the lack of safety information for Sprimeo.
Għandu jkun hemm kawtela f’ pazjenti bil- pressjoni għolja b’ indeboliment renali sever minħabba n- nuqqas ta ’ tagħrif dwar is - sigurtà li hemm għal Sprimeo.
Renal artery stenosis No data are available on the use of Sprimeo in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Stenożi ta ’ l- arterja renali M’ hemmx tagħrif dwar l- użu ta ’ Sprimeo f’ pazjenti bi stenożi ta ’ l- arterja renali unilaterali jew bilaterali, jew fi stenożi f’ kilwa waħda.
Sprimeo has no known clinically relevant interactions with medicinal products commonly used to treat hypertension or diabetes.
Sprimeo mhux magħruf li jagħmel interazzjonijiet li għandhom rilevanza klinika ma ’ prodotti mediċinali li jintużaw għall- kura ta ’ pressjoni għolja jew dijabete.
Co-administration of aliskiren with either valsartan (↓ 28%), metformin (↓ 28%), amlodipine (↑ 29%) or cimetidine (↑ 19%) resulted in between 20% and 30% change in Cmax or AUC of Sprimeo.
Meta aliskiren jingħata ma ’ valsartan (↓28%), metformin (↓28%), amlodipine (↑29%) jew cimetidine (↑19%) is- Cmax jew AUC ta ’ Sprimeo inbidlu b’ bejn 20% u 30%.
When administered with atorvastatin, steady-state Sprimeo AUC and Cmax increased by 50%.
Meta ngħata ma ’ atorvastatin, l- AUC u Cmax fi stat fiss ta ’ Sprimeo żdiedu b’ 50%.
Co- administration of Sprimeo had no significant impact on atorvastatin, valsartan, metformin or amlodipine pharmacokinetics.
Meta Sprimeo ingħata ma ’ atorvastatin, valsartan, metformin jew amlodipine dan ma kellux impatt sinifikanti fuq il- farmakokinetika tagħhom.
As a result no dose adjustment for Sprimeo or these co-administered medicinal products is necessary.
Għalhekk, m’ hemmx bżonn ta ’ aġġustar tad- doża għal Sprimeo jew ta ’ dawn il- prodotti mediċinali li jingħataw miegħu.
Digoxin bioavailability may be slightly decreased by Sprimeo.
3 Il- biodisponibilità ta ’ digoxin tista ’ titnaqqas xi ftit b’ Sprimeo.
3 Preliminary data suggest that irbesartan may decrease Sprimeo AUC and Cmax.
Tagħrif preliminari jindika li irbesartan jista ’ jnaqqas xi ftit l- AUC u s- Cmax ta ’ Sprimeo.
In experimental animals, it has been shown that P-gp is a major determinant of Sprimeo bioavailability.
F’ annimali esperimentali, intwera li P- gp jiddetermina bil- kbir il- biodisponibilità ta ’ Sprimeo.
John’ s wort, rifampicin) might therefore decrease the bioavailability of Sprimeo.
John’ s wort, rifampicin) għalhekk jistgħu jnaqqsu l- biodisponibilità ta ’ Sprimeo.
John’ s wort, rifampicin) might therefore decrease the bioavailability of Sprimeo.
John’ s Wort, rifampicin) għalhekk jistgħu jnaqqsu l- bijodisponibilità ta ’ Sprimeo.
It is therefore recommended that the effects be monitored when initiating and adjusting furosemide therapy to avoid possible underutilisation in clinical situations of volume overload.
Għalhekk huwa irrakkomandat li l- effetti jkunu monitorati meta tinbeda u tkun qed tiġi aġġustata t- terapija ta ’ furosemide biex dan ma jkunx sotto- utilizzat f’ sitwazzjonijiet kliniċi ta ’ volum żejjed.
Grapefruit juice should not be taken together with Sprimeo.
Il- meraq tal- grejpfrut m’ għandux jittieħed flimkien ma ’ Sprimeo.
Warfarin The effects of Sprimeo on warfarin pharmacokinetics have not been evaluated.
Warfarin L- effetti ta ’ Sprimeo fuq il- farmakokinetika ta ’ warfarin ma kienux evalwati.
Food intake Meals with a high fat content have been shown to reduce the absorption of Sprimeo substantially.
It- teħid ta ’ l- ikel Ikliet b’ kontenut ta ’ xaħam għoli ntwerew li jnaqqsu l- assorbiment ta ’ Sprimeo b’ mod sostanzjali.
Sprimeo was not teratogenic in rats or rabbits (see section 5.3).
Sprimeo ma kienx teratoġeniku fi frien jew fniek (ara sezzjoni 5. 3).
As for any medicine that acts directly on the RAS, Sprimeo should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (see section 4.3).
Bħal kull mediċina oħra li taħdem direttament fuq ir - RAS, Sprimeo m’ għandux jintuża waqt l- ewwel trimestru tat- tqala jew f’ nisa li qed jippjanaw biex joħorġu tqal u huwa kontraindikat waqt it- tieni u t- tielet trimestri (ara sezzjoni 4. 3).
If pregnancy is detected during therapy, Sprimeo should be discontinued accordingly.
Jekk jinsab li hemm tqala waqt it- terapija, Sprimeo għandu jitwaqqaf kemm jista ’ jkun malajr kif ikun xieraq.
Sprimeo was secreted in the milk of lactating rats.
Sprimeo għadda fil- ħalib ta ’ firien li kienu qed ireddgħu.
Sprimeo has negligible influence on the ability to drive and use machines.
Sprimeo ftit li xejn għandu influwenza fuq il- ħila biex issuq u tħaddem magni.
Sprimeo has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year.
Sprimeo ġie evalwat għas- sigurtà f’ aktar minn 7, 800 pazjent, li kienu jinkludu aktar minn 2, 300 li ingħataw kura għal aktar minn 6 xhur, u aktar minn 1, 200 għal aktar minn sena.
Treatment with Sprimeo resulted in an overall incidence of adverse reactions similar to placebo up to 300 mg.
Kura b’ Sprimeo wasslet għal inċidenza globali ta ’ reazzjonijiet avversi simili għal plaċebo sa ’ 300 mg.
The incidence of cough was similar in placebo (0.6%) and Sprimeo treated (0.9%) patients.
L- inċidenza tas- sogħla kienet simili f’ pazjenti ikkurati bi plaċebo (0. 6%) u b’ Sprimeo (0. 9%).
Angioedema has occurred during treatment with Sprimeo.
Anġjoedema seħħet waqt il- kura b’ Sprimeo.
In controlled clinical trials, angioedema occurred rarely during treatment with Sprimeo with rates comparable to treatment with placebo or hydrochlorothiazide.
Fi provi kliniċi kkontrollati, anġjoedema seħħet b’ mod rari waqt il- kura b’ Sprimeo b’ rati li setgħu jitqabblu mal- kura bi plaċebo jew hydrochlorthiazide.
Laboratory findings In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Sprimeo.
Sejbiet tal- laboratorju Fi provi kliniċi kkontrollati, bidliet klinikament rilevanti f’ parametri standard tal- laboratorju kienu assoċjati b’ mod mhux komuni ma ’ l- għoti ta ’ Sprimeo.
In clinical studies in hypertensive patients, Sprimeo had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
Fi studji kliniċi f’ pazjenti bi pressjoni għolja, Sprimeo ma kellux effetti klinikament importanti fuq il- kolesterol totali, lipoproteina tal- kolesterol ta ’ densità għolja (HDL- C), trigliċeridi ta ’ waqt is- sawm, glucose ta ’ waqt is- sawm jew uric acid.
Increases in serum potassium were minor and infrequent in patients with essential hypertension treated with Sprimeo alone (0.9% compared to 0.6% with placebo).
Żiediet tal- potassium fis- serum kienu minuri u mhux frekwenti f’ pazjenti bil - pressjoni għolja naturali kkurata b’ Sprimeo waħdu (0. 9% imqabbla ma ’ 0. 6% bil- plaċebo).
However, in one study where Sprimeo was used in combination with an ACEI in a diabetic population, increases in serum potassium were more frequent (5.5%).
Madankollu, fi studju wieħed fejn Sprimeo intuża ma ’ ACEI f’ popolazzjoni ta ’ pazjenti dijabetiċi iż - żiediet tal- potassium fis- serum kienu aktar frekwenti (5. 5%).
The most likely manifestations of overdosage would be hypotension, related to the antihypertensive effect of aliskiren.
L- aktar ħaga li x’ aktarx tidher b’ doża eċċessiva ta ’ Sprimeo tkun pressjoni baxxa, relatata ma ’ l- effett ta ’ aliskiren li jbaxxi l- pressjoni.
6 Hypertension In hypertensive patients, once-daily administration of Sprimeo at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
6 Pressjoni għolja F’ pazjenti bil- pressjoni għolja, l- għotja darba kuljum ta ’ Sprimeo b’ dożi ta ’ 150 mg u 300 mg ikkawżaw tnaqqis dipendenti mid- doża fil- pressjoni tad- demm sistolika u dijastolika li nżammu fuq perijodu sħiħ ta ’ 24 siegħa ta ’ l- intervall bejn id- dożi (b’ hekk żammew il- benefiċċju ta ’ kmieni filgħodu) b’ medja fil- proporzjon bejn l- ogħla u l- anqas għar- rispons dijastoliku sa ’ 98% għad- doża ta ’ 300 mg.
Sprimeo has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged 75 years or older.
Sprimeo kien studjat f’ 1, 864 pazjent ta ’ etajiet minn 65 sena ’ l fuq, u f’ 426 pazjent ta ’ etajiet minn 75 sena ’ l fuq.
Sprimeo monotherapy studies have shown blood pressure lowering effects comparable to other classes of antihypertensive agents including ACEI and ARB.
Studji b’ monoterapija b’ Sprimeo urew li l- effetti li jbaxxi l- pressjoni kienu jitqabblu ma ’ klassijiet oħra ta ’ aġenti li jbaxxu l- pressjoni inklużi ACEI u ARB.
Compared to a diuretic (hydrochlorothiazide - HCTZ), Sprimeo 300 mg lowered systolic/ diastolic blood pressure by 17.0/ 12.3 mmHg, compared to 14.4/ 10.5 mmHg for HCTZ 25 mg after 12 weeks of treatment.
Meta mqabbel ma ’ dijuretiku (hydrochlorothiazide - HCTZ), Sprimeo 300 mg naqqas il- pressjoni sistolika/ dijastolika tad- demm b’ 17. 0/ 12. 3 mmHg, imqabbel ma ’ 14. 2/ 10. 5 mmHg għal HCTZ 25 mg wara 12- il ġimgħa ta ’ kura.
In diabetic hypertensive patients, Sprimeo monotherapy was safe and effective.
F’ pazjenti dijabetiċi bil- pressjoni għolja, monoterapija ta ’ Sprimeo kienet sigura u effettiva.
Combination therapy studies are available for Sprimeo added to the diuretic hydrochlorothiazide, the ACEI ramipril, the calcium channel blocker amlodipine, the angiotensin receptor antagonist valsartan, and the beta blocker atenolol.
Hemm studji b’ terapija ta ’ kombinazzjoni għal Sprimeo miżjud mad- dijuretiku hydrochlorthiazide, l - ACEI ramipril, l- imblukkatur tal- kanali tal- calcium amlodipine, l- antagonist tar- riċettur ta ’ l - angiotensin valsartan, u l- imblukkatur beta atenolol.
Sprimeo induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide and to ramipril.
Sprimeo ikkawża tnaqqis fil- pressjoni tad- demm akbar meta żdied ma ’ hydrochlorthiazide u ma ’ ramipril.
In patients who did not adequately respond to 5 mg of the calcium channel blocker amlodipine, the addition of Sprimeo 150 mg had a blood-pressure-lowering effect similar to that obtained by increasing amlodipine dose to 10 mg, but had a lower incidence of oedema (aliskiren 150 mg/ amlodipine 5 mg 2.1% vs. amlodipine 10 mg 11.2%).
F’ pazjenti li ma kellhomx rispons xieraq għall- 5 mg ta ’ l- imblokkatur tal- kanali tal- calcium amlodipine, iż- żieda ta ’ Sprimeo 150 mg kellu effett li jbaxxi l- pressjoni simili għal dak miksub meta d- doża ta ’ amlodopine tiżdied għal 10 mg iżda kien hemm anqas każijiet ta ’ edema (aliskiren 150 mg/ amlodipine 5 mg 2. 1% vs amlodipine 10 mg 11. 2%).
Sprimeo in combination with the angiotensin receptor antagonist valsartan showed an additive antihypertensive effect in the study specifically designed to investigate the effect of the combination therapy.
Sprimeo flimkien ma ’ l- antagonist tar - riċettur ta ’ angiotensin valsartan wera effett ta ’ tnaqqis fil- pressjoni akbar fl- istudju li kien imfassal apposta sabiex jiġi mistħarreġ l- effett tat- terapija kombinata.