qanastek/EMEA-V3 huggingface dataset:
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li inti intolleranti għal xi zokkor, kellem lit- tabib tiegħek qabel tieħu dan il - prodott mediċinali.
HOW TO TAKE SONATA
KIF GĦANDEK TIEĦU SONATA
Always take Sonata exactly as your doctor has told you.
• Ħu d- doża eżatta li t- tabib tiegħek kitiblek.
You should not take a second dose within a single night.
Tbiddilx id- doża qabel titkellem mat- tabib tiegħek. • Id- doża ta ’ Sonata għall- adulti hija ta ’ 10mg eżatt qabel tidħol torqod jew meta tkun dħalt torqod u issibha diffiċli biex torqod.
There are different doses for people who are 65 or older, and those who have mild to moderate liver problems:
Qatt ma għandek tieħu t- tieni doża fl- istess lejl. • Hemm diversi dożi għan- nies ta ’ etajiet differenti bħal dozi għal dawk ta ’ anqas minn 65 sena, dożi għal dawk ta ’ 65 sena jew aktar, u għal dawk li għandhom problemi, minn ħfief għal moderati, tal- fwied:
65 or older:
65 jew akbar:
Take one 5 mg capsule Mild to moderate liver problems:
Ħu kapsula waħda ta ’ 5- mg Problemi tal- fwied minn ħfief għal moderati:
Take one 5 mg capsule
Tieħux it- tieni doza f’ lejl wieħed.
Sonata has been designed, so that if the contents of the capsule are dissolved in liquid, the liquid will change colour and become cloudy.
Sonata hu ddisinjat li jekk il- kontenut tal- kapsula jinħall f’ likwidu, il- likwidu ibiddel kuluru u jsir imċajpar.
If you take more Sonata than you should
Jekk tieħu Sonata aktar milli suppost:
Contact a doctor immediately and say how many capsules you have taken.
Ikkuntattja lit- tabib tiegħek immedjatament utgħidlu kemm- il kapsula tkun ħadt.
Do not go unaccompanied to seek medical help.
M’ għandekx tmur waħdek sabiex tfittex għajnuna medika.
If an overdose has been taken you may become increasingly drowsy very quickly, with high doses probably leading to a coma.
F’ kaz li tieħu doża eċċessiva tibda tħossok imħeddel b’ ritmu mgħaġġel u meta tittieħed doża akbar twassal għal koma.
If you forget to take Sonata
Jekk tinsa tieħu Sonata:
Just take your next capsule at the usual time, then go on as before.
Tinkwetax, ħu il- kapsula li jmiss fil- ħin tas- soltu, imbagħad ibqa ’ miexi bħal qabel.
Do not try and catch up on the doses you have missed.
Tippruvax li tieħu xi dożi biex tlaħħaq ma dawk li tkun insejt tieħu.
If you stop taking Sonata
Jekk tieqaf tieħu Sonata:
On stopping treatment, your original sleeplessness may return and you may experience symptoms such as mood changes, anxiety, and restlessness.
Mal- waqfien tat- trattament, in- nuqqas t’ irqad oriġinali jista ’ jerġa ’ jiġi u tista ’ ikollha esperjenza bħal bidla fil- burdati, anzjeta u nuqqas ta ’ kwiet.
If you suffer from these symptoms, ask your doctor for advice.
Jekk ikollok dawn is- sintomi ħu parir mit- tabib tiegħek.
Like all medicines, Sonata can cause side effects, although not everybody gets them.
Bħal kull mediċina, Sonata jista’ jħalli effetti mhux mixtieqa, għalkemm mhux kulhadd jiġi affettwat bl- istess mod.
If you notice any of the following, or any other changes in your health, do tell your doctor as soon as possible.
Meta tinnota dawn il- bidliet għandek tgħarraf lit- tabib tiegħek minnufih.
The frequency of possible side effects listed below is defined using the following convertion:
Il- frekwenza tal- possibilita ’ tal- effetti kollaterali hija spjegata b’ dan il- mod:
35 very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data)
Komuni ħafna (taffettwa aktar minn 1 f ’ 10 pazjenti) Komuni (taffettwa minn 1 sa 10 kull 100pazjent) Mhux komuni (taffettwa minn 1 sa 10 minn kull 1000pazjent) Rari (taffettwa minn 1 sa 10 minn kull 10, 000 pazjent) Mhux magħruf (m’ hemmx riżultati biżżejjed)
Side effects that may occur commonly: drowsiness; memory difficulties; sensations like tingling, e. g. in the extremities (paraesthesia); painful menstruation.
35 Effetti kollaterali l- aktar komuni: ħedla; diffikultajiet fil- memorja; sensazzjonjiiet bħal tnemnim qawwi (parasteżija) fl- estremitajiet; uġigħ mal- menstrwazzjoni.
Uncommon side effects include: dizziness; weakness; reduced coordination of movements; unsteadiness and/ or falls (ataxia); decreased concentration; apathy; restlessness; depression; agitation; irritability; confusion, abnormal thinking and behaviour (extroversion that seems out of character, decreased inhibition, aggressiveness, rages, delusion, depersonalisation, psychosis); nightmares; hallucinations; double vision or other sight problems; increased sensitivity to noise (hyperacusis); smell disorder (parosmia); speech disorders, including slurred speech; numbness, e. g. in the extremities (hypoaesthesia); nausea; decreased appetite; increased sensitivity to light (sunlight, UV light); feeling vaguely ill (malaise).
Effetti kollaterali mhux komuni: sturdament; dgħjufija; tnaqqis ta ’ ko- ordinazzjoni fil- movimenti; nuqqas li wieħed jkun sod / jew waqgħat (ataxia); nuqqas ta ’ konċentrazzjoni; apatija; nuqqas ta ’ sabar; dipressjoni, agitazzjoni; burdati ħżiena; konfużjoni, ħsibijiet u mġiba mhux tas- soltu (soċjabbli mhux tas- soltu, nuqqas ta ’ inibizzjoni, aggressjoni, rabja, delużjoni, nuqqas ta ’ personalità, barra minn sensih); ħmir il- lejl; alluċinazzjoniet, viżjoni doppja jew problemi tal- vista; żjieda fis- sensittiva għall - ħsejjes (hyperacusis); disordni fix- xamm (parosmia); diskors mħawwad, inkluż diskors mhux ċar); nuqqas ta ’ sensazzjoni, eż. fl- estremitajiet (hypoaesthesia); taqlib ta ’ l- istonku; nuqqas ta ’ aptit; żieda fis- sensittiva għad- dawl (dawl tax- xemx, dawl UV); tħossok m’ intix f’ siktek (malaise).
In very rare cases, allergic reactions, some severe, sometimes with difficulty in breathing, have been reported and may require immediate medical care.
F’ każijiet rari ħafna, re- azzjonijiet allerġiċi, x’ uħud severi, xi minn daqqiet diffikulta biex jittieħed in - nifs, ġew rapportati.
An allergic reaction may also include a rash, itching, or swelling of the face, lips, throat or tongue.
F’ każijiet bħal dawn għandhom jiġu rrapurtati minnufih u tintalab għajnuna medika.
Increases in transaminases (a group of liver enzymes occurring naturally in the blood) have been reported, which may be a sign of liver problems.
Kien hemm rapporti ta ’ żieda fit- transaminases (grupp ta ’ enżimi fil- fwied li jinsabu b’ mod naturali fid- demm), li jista ’ jfisser li hemm problemi fil- fwied.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti kollaterali jiggrava jew jekk tinnota xi effetti kollaterali li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE SONATA
KIF TAĦŻEN SONATA
Do not use Sonata after the expiry date, which is stated on the carton after EXP.
Tużax Sonata wara d- data ta ’ skadenza li tidher fuq it- tikketta li hemm fuq il- kartuna.
Do not store above 30ºC.
Taħżenx f’ temperatura ’ l fuq minn 30º C.
If you have any further questions, please consult your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet, staqsi lit- tabib jew l- ispiżjar tiegħek.
Medicines should not be disposed of via wastewater or household waste.
Mediċini m’ għandhomx jintremew f’ għejjun jew fis- sistema tad- drenaġġ.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill- ispizjar tiegħek kif tiddisponi minn medicini li m’ għandekx bzonn.
These measures will help to protect the environment.
Mizuri bħal dawn jipproteġu l- ambjent.
What Sonata contains
X’ fih Sonata
The active substance in each Sonata hard capsule is zaleplon 5 mg.
Is- sustanza attiva f’ kull kapsula iebsa ta ’ Sonata hi zaleplon 5 mg.
36 The other ingredients are microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Is- sustanzi l- oħra huma microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Ingredients of the capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate and silicon dioxide.
Is- sustanzi li jinsabu fil- qoxra tal- kapsula huma: titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate u silicon dioxide.
Printing inks on the shell contain the following (gold ink S-13050): shellac, lecithin, simethicone, yellow iron oxide (E172).
Il- linek ta ’ l- istampar fuq il- qoxra tal- kapsula jikkonsistu minn dak li ġej (gold ink S- 13050): shellac, lecithin, simethicone, yellow iron oxide (E172).
What Sonata looks like and contents of the pack
36 Id- dehra tal- prodott u d- daqs tal- pakkett:
Sonata 5 mg hard capsules, which contain an intensely dark blue powder, have a light brown cap, with gold imprint “ W”, and white body, with gold imprint “ 5 mg”.
Sonata, 5 mg kapsuli iebsin, li jikkonsistu minn trab blu skur qawwi, għandhom ras kannella ċara, b ’ intaljar “ W ” lewn id- deheb fuq il- korp, u “ 5 mg ” intaljati lewn id- deheb.
They are packed in blisters.
Huma ppakkjati f’ folji.
Each pack contains 7, 10 or 14 hard capsules.
Kull pakkett fih 7, 10 jew 14- il kapsula iebsa.
Marketing Authorisation Holder and Manufacturer
Sid l- Awtorizazzjoni għall- kummerċ u l- Manifattur
Marketing Authorisation holder:
Sid l- Awtorizzazzjoni għall- Kummerċ:
Wyeth Medica Ireland, Little Connell, Newbridge, Co.
Manifattur hi Wyeth Medica Ireland, Little Connell, Newbridge, Co.
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 għamel kuntatt mar- rappreżentat lokali tas- Sid ta ’ l- Awtorizzazzjoni għall- Kummerċ.
Viale Brenta, 18 I-20139 Milano Tel: +39 02 57 416 1
Suomi/ Finland Italia Meda Oy Meda Pharma S. p. A.
Suomi/ Finland Meda Oy Vaisalantie 4 FIN-02130 Espoo Puh/ Tel: +358 20 720 9550
Vaisalantie 4 Viale Brenta, 18 FIN- 02130 Espoo I- 20139 Milano Puh/ Tel: +358 20 720 9550 Tel: +39 02 57 416 1
This leaflet was last approved in
Dan il- fuljett ġie approvat l- aħħar f ’ ………..
39 PACKAGE LEAFLET:
39 FULJETT DWAR IL- PAKKETT:
• hypersensitivity (an allergy) to zaleplon or to any other ingredients of Sonata • sleep apnoea syndrome (stopping breathing for short periods while asleep) • severe kidney of liver problems • myasthenia gravis (very weak or tired muscles) • severe breathing or chest problems
• jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal zaleplon jew xi sustanzi oħra ta ’ Sonata, li jinkludu indigo carmine (E132) • tbati minn apnea waqt l- irqad (waqfien ta ’ nifs għall- ħinijiet qosra waqt l- irqad) • problemi gravi tal- kliewi u tal- fwied • myasthenia gravis (muskoli dgħajfa ħafna jew għajjiena) • problemi fit- teħid tan- nifs jew problemi tas- sider
Once physical dependence has developed, abrupt termination of treatment may be accompanied by withdrawal symptoms.
40 • Tiħux it- tieni doża ta ’ Sonata fl- istess lejl. • Jekk tibqa ’ ma tistax torqod kellem lit- tabib tiegħek • Nuqqas ta ’ sabar, aġitazzjoni, irritabilita, aggressjoni, ħsibijiet mhux tas- soltu, delużjoni, ħmar il- lejl, alluċinazzjonijiet, psikożi, mġieba mhux tas- soltu ġew innotati f’ nies li uzaw mediċina tal- irqad bħal Sonata.
40 • Do not use Sonata or any other sleeping medicine for longer than your doctor tells you to. • Do not use a second dose of Sonata within a single night. • If your sleeplessness persists or worsens after a short course of Sonata treatment contact your doctor. • There is a chance that you may experience a certain type of temporary memory loss (amnesia) and lack of coordination when taking sleep medicines.
Jekk taħseb li għandek xi wieħed minn dawn is- sintomi ara lit- tabib tiegħek. • Hemm iċ- ċans li tista ’ jkollok esperjenza temporanja ta ’ ċerta tip ta ’ telf ta ’ memorja (amnesija) u nuqqas ta ’ ko- ordinazzjoni meta tieħu mediċina tal- irqad.
You should tell your doctor or pharmacist if you are taking cimetidine (a stomach medicines) or erythromycin (an antibiotic).
Għandek tgħarraf lit- tabib jew lill- ispiżjar tiegħek jekk inti qed tieħu cimetidine (mediċina ta ’ l - istonku) jew erythromycin (antibijotiku).
Never drink alcohol while you are being treated with Sonata (see “ Take Special care with Sonata”).
(ara “ Ħu attenzjoni speċjali b’ Sonata ”).
Sonata should not be taken at this time because there are not enough clinical data available to assess its safety during breast-feeding.
Sonata m’ għandiex tittieħed f’ dan iż- żmien, għaliex għad m’ hemmx tagħrif kliniku biżżejjed biex titkejjel kemm hi ta ’ bla periklu magħtul it- treddigħ.
41 Driving and using machines
Sewqan u tħaddim ta ’ magni
If affected do not drive or operate machinery
Jekk tħossok hekk issuqx jew tħaddimx makkinarju.
Important information about some of the ingredients of Sonata
41 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Sonata
42 very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data)
Komuni ħafna (taffettwa aktar minn 1 f ’ 10 pazjenti) Komuni (taffettwa minn 1 sa 10 kull 100pazjent) Mhux komuni (taffettwa minn 1 sa 10 minn kull 1000pazjent) Rari (taffettwa minn 1 sa 10 minn kull 10, 000 pazjent) Mhux magħruf (m’ hemmx dejta biżżejjed)
Side effects that may occur commonly: drowsiness; memory difficulties; sensations like tingling, e. g. in the extremities (paraesthesia); painful menstruation
42 Effetti kollaterali l- aktar komuni: ħedla; diffikultajiet fil- memorja; sensazzjonjiiet bħal tnemnim qawwi (parasteżija) fl- estremitajiet; uġigħ mal- menstrwazzjoni.
Uncommon side effects include: dizziness; weakness; reduced coordination of movements; unsteadiness and/ or falls (ataxia); decreased concentration; apathy; restlessness; depression; agitation; irritability; confusion; abnormal thinking and behaviour (extroversion that seems out of character, decreased inhibition, aggressiveness, rages, delusion, depersonalisation, psychosis); nightmares; hallucinations; double vision or other sight problems; increased sensitivity to noise (hyperacusis); smell disorder (parosmia); speech disorders, including slurred speech; numbness, e. g. in the extremities (hypoaesthesia); nausea; decreased appetite; increased sensitivity to light (sunlight, UV light); feeling vaguely ill (malaise).
Effetti kollaterali mhux komuni: sturdament; dgħjufija; tnaqqis ta ’ ko- ordinazzjoni fil- movimenti; nuqqas li wieħed jkun sod / jew waqgħat (ataxia); nuqqas ta ’ konċentrazzjoni; apatija; nuqqas ta ’ sabar; dipressjoni, agitazzjoni; burdati ħżiena; konfużjoni, ħsibijiet u mġiba mhux tas- soltu (soċjabbli mhux tas- soltu, nuqqas ta ’ inibizzjoni, aggressjoni, rabja, delużjoni, nuqqas ta ’ personalità, barra minn sensih); ħmir il- lejl; alluċinazzjoniet, viżjoni doppja jew problemi tal- vista; żjieda fis- sensittiva għall - ħsejjes (hyperacusis); disordni fix- xamm (parosmia); diskors mħawwad, inkluż diskors mhux ċar); nuqqas ta ’ sensazzjoni, eż. fl- estremitajiet (hypoaesthesia); taqlib ta ’ l- istonku; nuqqas ta ’ aptit; żieda fis- sensittiva għad- dawl (dawl tax- xemx, dawl UV); tħossok m’ intix f’ siktek (malaise).
Do not use Sonata after the expiry date which is stated on the carton after EXP.
Tużax Sonata wara d- data ta ’ skadenza li tidher fuq it- tikketta li hemm fuq il- kartuna.
The active substance in each Sonata hard capsule is zaleplon 10 mg.
Is- sustanza attiva ta ’ kull kapsula iebsa ta ’ Sonata hi zaleplon 10 mg.
43 The other ingredients are microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Is- sustanzi l- oħra huma Mmicrocrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Ingredients of the capsule shell: gelatin, titanium dioxide (E171), sodium lauryl sulphate and silicon dioxide.
Is- sustanzi li jinsabu fil- qoxra tal- kapsula huma: titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate u silicon dioxide.
Printing inks on the shell contain the following (pink ink SW-1105): shellac, titanium dioxide (E171), ammonium hydroxide, red iron oxide (E172), yellow iron oxide (E172).
Il- linek ta ’ l- istampar fuq il- qoxra tal- kapsula jikkonsistu minn dak li ġej (gold ink S- 13050): shellac, lecithin, simethicone, yellow iron oxide (E172).
What Sonata looks like and contents of the pack
43 Id- Dehra tal- prodott u d- daqs tal- pakkett:
Sonata 10 mg hard capsules, which contain an intensely dark blue powder, have a white cap, with pink imprint “ W”, and white body, with pink imprint “ 10 mg”.
Sonata, 10 mg kapsuli iebsin, li jikkonsistu minn trab blu skur qawwi, għandhom ras bajda ċara, b ’ intaljar “ W ” lewn roza fuq il- korp, u “ 10 mg ” intaljati lewn roza.
Each pack contains 7, 10 or 14 hard capsules.
Kull pakkett fih 7, 10 jew 14 kapsula iebsa.
Meda AB Pipers väg 2 S-170 09 Solna Sweden
Meda AB Pipers väg 2 S- 170 09 Solna Svezia
Eesti MediNet International Ltd.
44 Österreich Eesti MEDA Pharma GmbH MediNet International Ltd.
Sverige Meda AB Box 906 S-170 09 Solna Tel: +46 8 630 1900
45 United Kingdom Latvija Meda Pharmaceuticals Ltd.
What is SonoVue?
X’ inhu Sono Vue?
SonoVue is a medicine containing the active substance sulphur hexafluoride (a gas).
SonoVue hija mediċina li fiha s- sustanza attiva sulphur hexafluoride (tip ta ’ gass).
It is available as a kit including one vial of gas and powder and one pre-filled syringe containing 5 ml of solvent.
Jiġi bħala pakkett li jkun fih fjala bil- gass u trab u siringa mimlija għal- lest b’ 5 ml ta ’ solvent.
When made up into a solution, 1 ml of SonoVue contains 8 microlitres of sulphur hexafluoride gas as ‘ microbubbles ’ in suspension in a liquid.
Meta jinħall f’ soluzzjoni, 1 ml ta ’ SonoVue jkun fih 8 mikrolitri tal- gass sulphur hexafluoride f ’ ‘ mikrobżieżaq ’ f’ sospensjoni f’ likwidu.
What is SonoVue used for?
Għal xiex jintuża Sono Vue?
SonoVue is for diagnostic use only.
SonoVue hu għal użu dijanjostiku biss.
It is a contrast agent (it helps make internal body structures visible during imaging tests).
Hu aġent tal- kuntrast (li jgħin biex jagħmel viżibbli l- istrutturi interni tal- ġisem waqt testijiet bil- produzzjoni ta ’ immaġni).
SonoVue is used in tests that measure how ultrasound travels within the body because it improves the ability of the blood to create an echo.
SonoVue jintuża f’ testijiet li jkejlu kif l - imwieġ ultrasoniċi jivvjaġġaw fil- ġisem għax itejjeb l- abilità tad- demm li joħloq eku.
It is only used when the results of the test without a contrast agent are inconclusive.
Jintuża biss meta r- riżultati tat- test mingħajr aġent tal- kuntrast ma jkunu taw l- ebda riżultat.
SonoVue is used in: • echocardiography (a diagnostic test where an image of the heart is obtained).
SonoVue jintuża: • Fl- ekokardjografija (test dijanjostiku li fih tinkiseb immaġni tal- qalb).
It is used to obtain a clearer scan of the chambers of the heart, especially of the left ventricle, in patients with suspected or confirmed coronary artery disease. • Doppler (a diagnostic test that measures the speed of blood flow).
Jintuża biex jinkiseb skenn iktar ċar tal- kavitajiet tal- qalb, speċjalment tal- ventrikolu tax- xellug, f’ pazjenti b’ suspett ta ’ mard ta ’ l- arterji koronarji jew b’ mard ta ’ l- arterji koronarji konfermat. • Doppler (test dijanjostiku li jkejjel il- ħeffa tal- mixi tad- demm).
SonoVue can be used in Doppler tests for large blood vessels, such as those in the head, those leading to the head or the main vein to the liver, or for smaller blood vessels such as those in lesions (areas of disease) in the breast or liver.
SonoVue jista ’ jintuża fit- testijiet tad- Doppler għal arterji u vini kbar, bħal dawk fir- ras, dawk li jwasslu għar- ras u l- vina ewlenija għall- fwied, jew għal arterji u vini iżgħar bħal dawk f’ leżjonijiet (żoni ta ’ mard) fis- sider jew fil - fwied.
How is SonoVue used?
Kif jintuża Pylobactel?
SonoVue should only be used by doctors who have experience in diagnostic ultrasound imaging.
SonoVue għandu jintuża biss minn tobba li jkollhom esperjenza fil- produzzjoni ta ’ immaġni ultrasoniċi dijanjosiċi.
It is injected intravenously (into a vein) before the test is carried out, as a 2- or 2.4-ml dose depending on which test is being carried out.
Jiġi injettat f’ vina qabel ma jsir it- test, f’ doża ta ’ 2 jew 2. 4 ml skond liema test ikun qed isir.
The dose can be repeated.
Id- doża tista ’ tiġi ripetuta.
SonoVue has not been studied in patients aged 18 years or younger and should not be used in this group.
SonoVue ma ġiex studjat f’ pazjenti ta ’ 18- il sena jew iżgħar u m’ għandux jintuża f’ dan il- grupp.
How does SonoVue work?
Kif jaħdem Sono Vue?
The active substance in SonoVue, sodium hexafluoride, is a gas that is not soluble in the blood.
Is- sustanza attiva f’ SonoVue, sodium hexafluoride, hu gass li ma jinħallx fid- demm.
When SonoVue is made up into a suspension, the gas is trapped in tiny bubbles called microbubbles.
Meta SonoVue jifforma sospensjoni, il- gass jinqabad fi bżieżaq żgħar li jissejħu mikrobżieżaq.
After injection, the microbubbles travel in the blood, where they reflect ultrasound waves more than the surrounding tissues.
Wara l- injezzjoni, il - mikrobżieżaq jivvjaġġaw fid- demm, fejn jirreflettu l- imwieġ ultrasoniċi iktar mit- tessuti tal- madwar.
This helps to enhance the results of tests that rely on measuring ultrasound, such as echocardiography and Doppler tests.
Dan jgħin biex isaħħaħ ir- riżultati tat- testijiet li jiddependu fuq il- kejl ultrasoniku, bħat- testijiet ta ’ l - ekokardjografija u tad- Doppler.
The gas is removed from the body through the lungs.
Il- gass jitneħħa mill- ġisem mill- pulmun.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has SonoVue been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat Sono Vue?
SonoVue has been studied in a total of 895 patients in six main studies.
B’ kollox SonoVue ġie studjat fuq 895 pazjent f’ sitt studji ewlenin.
These included three studies of echocardiography and three studies of Doppler.
Dawn inkludew tliet studji ta ’ l - ekokardjografija u tliet studji tad- Doppler.
The echocardiography studies involved a total of 317 patients, and compared the effects of SonoVue with those of another contrast agent and of placebo (a dummy treatment).
Fl- istudji ta ’ l- ekokardjografija b’ kollox ħadu sehem 317- il pazjent u qabblu l- effetti ta ’ SonoVue ma ’ dawk ta ’ aġent tal- kuntrast ieħor u ma ’ plaċebo (trattament finta).
The Doppler studies involved 361 patients who were being tested for abnormalities in large blood vessels, and 217 patients being tested for abnormalities in smaller vessels.
Fl- istudji tad- Doppler ħadu sehem 361 pazjent li ġew ittestjati għal anormalitajiet fl- arterji u l- vini l - kbar, u 217- il pazjent li ġew ittestjati għal anormalitajiet f’ arterji u vini żgħar.
In these studies, SonoVue was not compared with any other medicine, but the results of the test with SonoVue were compared to the ‘ gold standard’, such as angiography (X-rays of blood vessels).
F’ dawn l- istudji, SonoVue ma tqabbilx ma ’ xi mediċina oħra, iżda r- riżultati tat- test ma ’ SonoVue tqabblu mat - trattament ideali, bħall- anġjografija (eksrejs ta ’ l- arterji u l- vini).
The main measure of effectiveness was how clear the images obtained in the test were.
Il- mezz ewlieni tal- kejl ta ’ l- effikaċja kien kemm kienu ċari l- immaġni li nkisbu fit- test.
What benefit has SonoVue shown during the studies?
X’ inhu l- benefiċċju ta ’ Sono Vue li ntwera f’ dawn l- istudji?
In the echocardiography studies, SonoVue was more effective than the comparator and than placebo in improving the clarity of the image obtained of the left ventricle and left ventricle border.
Fl- istudji ta ’ l- ekokardjografija, SonoVue kien iktar effettiv mill- mediċina li tqabbel magħha u mill - plaċebo fit- titjib taċ- ċarezza ta ’ l- immaġni miksuba tal- ventrikolu tax- xellug u tal- burdura tal - ventrikolu tax- xellug.
In the Doppler studies, using SonoVue to measure blood flow in large blood vessels improved the quality of the scan when testing the cerebral arteries (in the head), the carotids (in the neck) and the portal vein (leading to the liver), but not the renal arteries (leading to the kidneys).
Fl- istudji tad- Doppler, l- użu ta ’ SonoVue għall- kejl tal- fluss tad- demm fl- arterji u l- vini l- kbar tejjeb il- kwalità ta ’ l- iskenn meta jiġu ttestjati l- arterji ċerebrali (fir- ras), l- arterji tal- karotide (fil- għonq) u l - vina portali (li twassal għall- fwied), iżda mhux l- arterji li jwasslu għall- kliewi.
For the smaller vessels, SonoVue led to better quality scans when looking at the blood flow in breast and liver lesions.
Għall- arterji u l- vini iżgħar, SonoVue wassal għal skenns ta ’ kwalità aħjar meta ġie studjat il- fluss tad- demm f’ leżjonijiet fis- sider u fil- fwied.
However, this was not observed for lesions in the pancreas, kidney, ovary or prostate gland.
Madankollu, dan ma kienx osservat għal leżjonijiet fil- frixa, fil- kliewi, fl- ovarji jew fil- prostata.
What is the risk associated with SonoVue?
X’ inhu r- risku assoċjat ma ’ Sono Vue?
The most common side effects with SonoVue (seen in between 1 and 10 patients in 100) are headache, nausea (feeling sick), injection site pain, injection site reactions, including bruising, burning, and paraesthesia (unusual sensations like pins and needles) at the injection site.
L- iktar effetti sekondarji komuni ma ’ SonoVue (li dehru b’ bejn pazjent wieħed u għaxra minn kull 100) huma l- uġigħ ta ’ ras, id- dardir, uġigħ fis- sit ta ’ l- injezzjoni, reazzjonijiet fis- sit ta ’ l- injezzjoni, inkluż tbenġil, ħruq, u sensazzjonijiet mhux tas- soltu bħal tnemnim) fis- sit ta ’ l- injezzjoni.
For the full list of all side effects reported with SonoVue, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rappurtati ma ’ SonoVue, ara l- Fuljett ta ’ Tagħrif.
SonoVue should not be used in people who may be hypersensitive (allergic) to sulphur hexafluoride or any of the other ingredients.
SonoVue m’ għandux jintuża minn persuni li jkunu allerġiċi għal sulphur hexafluoride jew għal xi sustanzi oħra tiegħu.
SonoVue should also not be used in the following patients: • patients with recent acute coronary syndrome (symptoms involving the heart) or unstable ischaemic cardiac disease (reduced blood supply to the heart), • patients known to have right-to-left shunts (abnormal movement of blood within the heart), severe pulmonary hypertension (high blood pressure in the pulmonary artery, the blood vessel that leads from the heart to the lungs), uncontrolled hypertension (high blood pressure) or adult respiratory distress syndrome (severe fluid build-up in both lungs), • pregnant or breast-feeding women.
SonoVue lanqas m’ għandu jintuża minn dawn il- pazjenti: • Pazjenti bis- sindromu koronarju akut (sintomi li jinvolvu l- qalb) riċenti jew mard tal- qalb iskemiku instabbli (tnaqqis fit- twassil tad- demm lill- qalb), • Pazjenti li jkollhom shunts mil- lemin għax- xellug (movement anormali tad- demm fil- qalb), pressjoni pulmonarja għojla severa (pressjoni tad- demm għolja fl- arterja pulmonarja, l- arterja li twassal id- demm mill- qalb għall- pulmuni), pressjoni għolja mhux ikkontrollata jew is- sindromu tad- distress respiratorju ta ’ l- adulti (il- ġmigħ sever ta ’ fluwidu fiż- żewġ pulmuni), • Nisa tqal jew li jkunu qed ireddgħu.
Why has SonoVue been approved?
Għaliex ġie approvat Sono Vue?
The Committee for Medicinal products for Human Use (CHMP) decided that SonoVue’ s benefits are greater than its risks to enhance the echogenicity (ultrasound contrast) of the blood in echocardiography in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation, and in Doppler of macrovasculature (cerebral arteries, extracranial carotid or peripheral arteries and portal vein) or microvasculature (liver and breast lesions).
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ SonoVue huma ikbar mir- riskji tiegħu meta jintuża biex isaħħaħ l- ekoġeneċità (il- kuntrast ultrasoniku) tad- demm fl- ekokardjografija f’ pazjenti b’ suspett jew konferma ta ’ mard kardjovaskulari biex jagħti dehra opaka lill- kavitajiet tal- qalb u jsaħħaħ id- delineazzjoni tal- burduri tal- ventrikolu tax- xellug, u fid- Doppler tal- makrovaskulatura (arterji ċerebrali, arterji tal- karotide barra mill- kranju jew periferali u l- vina portali) jew tal- mikrovaskulatura (leżjonijiet fil- fwied u fis- sider).
The Committee recommended that SonoVue be given marketing authorisation.
Il- Kumtat irrakkomanda li SonoVue jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about SonoVue:
Tagħrif ieħor dwar SonoVue:
The European Commission granted a marketing authorisation valid throughout the European Union for SonoVue to Bracco International B. V. on 26 March 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal SonoVue valida fl- Unjoni Ewropea kollha lil Bracco International B. V. fis- 26 ta ’ Marzu 2001.
The marketing authorisation was renewed on 26 March 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fis- 26 ta ’ Marzu 2006.
The full EPAR for SonoVue is available here.
L- EPAR sħiħ għal SonoVue huwa disponibbli minn hawnhekk.
Packaging
Ippakkettar
Powder and solvent for dispersion for injection
Trab u solvent għad - dispersjoni għall - injezzjoni
1 vial + 1 pre-filled syringe + 1'MiniSpike 'rec. device
1 kunjett + 1 siringa mimlija għal- lest + 1 'MiniSpike' tagħmir rec.
SonoVue 8 microlitres / ml powder and solvent for dispersion for injection
SonoVue, 8 mikrolitri / ml, trab u solvent għal dispersjoni għall- injezzjoni
One ml contains 8 µl of sulphur hexafluoride microbubbles On reconstitution as directed, 1 ml of the resulting dispersion contains 8 µl sulphur hexafluoride in the microbubbles, equivalent to 45 microgrammes.
Wara li ssir r- rikostituzzjoni kif indikat, 1 ml tad- dispersjoni li tifforma jkun fiha 8 µl ta ’ ezaflorinat tal- kubrit. fil- bżieżaq żgħar, ekwivalenti għal 45 mikrogrammi.
SonoVue is a kit including 1 vial containing 25 mg of lyophilised powder 1 pre-filled syringe containing 5 ml sodium chloride 1 Mini-Spike transfer system
Trab u solvent għal dispersjoni għall- injezzjoni SonoVue hu kitt li jinkludi 1 kunjett fih 25 mg ta ’ trab lyophilised 1 siringa mimlija għal- lest fiha 5 ml ta ’ sodium chloride 1 Mini- Spike sistema tat- trasferiment
Information on the appearance of the reconstituted solution is given in section 6.6.
Informazzjoni fuq id- dehra tas- soluzzjoni rikostitwita tinsab f’ sezzjoni 6. 6.
SonoVue is for use with ultrasound imaging to enhance the echogenicity of the blood, which results in an improved signal to noise ratio.
SonoVue hu għall- użu waqt il- proċess ta ’ l- immaġini bl- ultrasound biex tittejjeb l- ekoġeniċità tad- demm, li jirriżulta f’ titjib fir- rata fis- signal to noise ratio.
SonoVue should only be used in patients where study without contrast enhancement is inconclusive.
SonoVue għandu jintuża biss f’ pazjenti fejn l- istudju mingħajr it- titjib tal- kuntrast ikun inkonklussiv.
Echocardiography
Ekokardjografija
SonoVue is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation.
SonoVue hu sustanza tal- kuntrast ekokardjografiku transpulmonari għall- użu f’ pazjenti fejn hemm suspett ta ’ mard kardjovaskolari, jew mard kardjovaskolari li kien stabbilit, biex jipprovdi l- opakifikazzjoni tal- kompartimenti tal- qalb u jtejjeb id- delineazzjoni tal- fruntiera endokardjali ventrikulari tax- xellug.
Doppler of macrovasculature
Doppler tal- makrovaskultura
SonoVue increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extracranial carotid or peripheral arteries by improving the Doppler signal to noise ratio.
SonoVue jżid l- eżattezza ta ’ l- indikazzjoni jew l- esklużjoni ta ’ anormalitajiet fl- arterji ċerebrali u fil- karotide extrakranjali jew fl- arterji periferali billi jtejjeb ir- rata Doppler signal to noise ratio.
SonoVue increases the quality of the Doppler flow image and the duration of clinically-useful signal enhancement in portal vein assessment.
SonoVue jżid il- kwalità ta ’ l- immaġni ta ’ l- influss Doppler u t- tul ta ’ ħin tat- titjib tas- sinjal b’ mod li jkun klinikament utli fl- evalwazzjoni tal- vina portali.
Doppler of microvasculature
Doppler tal- mikrovaskulatura
SonoVue improves display of the vascularity of liver and breast lesions during Doppler sonography, leading to more specific lesion characterisation.
SonoVue itejjeb il- kwalità tad- dehra tal- vaskularità tal- leżjonijiet fil fwied u fis- sider matul is- sonografija bid- Doppler, li jwassal għal karatterizzazzjoni aktar speċifika tal- leżjonijiet.
This product should only be used by physicians experienced in diagnostic ultrasound imaging.
Dan il- prodott għandu jintuża biss minn tobba b’ esperjenza fl- ultrasound għall- użu dijanjostiku.
2 The recommended doses of SonoVue are:
2 Id- dożi rakkomandati ta ’ SonoVue huma:
B-mode imaging of cardiac chambers, at rest or with stress:
Immaġni B- mode tal- kompartimenti tal- qalb, waqt l- pazjent ikun mistrieħ jew waqt li jkun taħt stress:
Vascular Doppler imaging:
Immaġni vaskulari bid- Doppler:
During a single examination, a second injection of the recommended dose can be made when deemed necessary by the physician.
Waqt eżami wieħed, tista ’ tingħata t- tieni injezzjoni tad- doża rakkomandata meta t -- tabib jikkunsidra li dan ikun meħtieġ.
Elderly Patients The dosage recommendations also apply to elderly patients.
Pazjenti Anzjani Ir- rakkomandazzjonijiet tad- dożaġġ jgħoddu wkoll għall- pazjenti anzjani.
Paediatric Patients The safety and effectiveness of SonoVue in patients under 18 years old has not been established and the product should not be used in these patients.
Pazjenti Pedjatriċi Is- sigurtà u l- effettività ta ’ SonoVue f’ pazjenti taħt it- 18- il sena ma kienux stabbiliti, u l- prodott m’ għandux jintuża f’ dawn il- pazjenti.
The microbubble dispersion is 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.
Id- dispersjoni tal- bużżieqa mikroskopika għandha tiġi ppreparata qabel l- użu permezz ta ’ injezzjoni minn ġos- septum ta ’ 5 ml ta ’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni fil- kontenut tal- kunjett.
The vial is then shaken vigorously for a few seconds until the lyophilisate is completely dissolved.
Il- kunjett imbagħad għandu jitħawwad sew għal ftit sekondi sakemm il- lyophilisate ikun inħall kompletament.
The desired volume of the dispersion can be drawn into a syringe any time up to six hours after reconstitution.
Il- volum mixtieq tad- dispersjoni jista ’ jinġibed fis- siringa fi kwalunkwe ħin sa sitt sigħat wara r- rikostituzzjoni.
Just before drawing into the syringe, the vial should be agitated to re-suspend the microbubbles.
Eżatt qabel ma jiġbed fis- siringa, il- kunjett għandu jerġa ’ jitħawwad biex il- bżieżaq żgħar jiffurmaw suspensjoni mill- ġdid.
SonoVue should be administered immediately after drawing into the syringe by injection into a peripheral vein.
SonoVue għandu jittieħed immedjatament wara li jkun inġibed fis- siringa permezz ta ’ injezzjoni ġo vina periferali.
Every injection should be followed by a flush with 5 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection.
Wara kull injezzjoni, il- parti tal- ġisem fejn tkun ngħatat għandha titlaħlaħ b’ 5 ml ta ’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni.
For instructions for preparation see section 6.6.
Għal struzzjonijiet dwar il- preparazzjoni, ara sezzjoni 6. 6.
SonoVue should not be administered to patients with known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue.
SonoVue m’ għandux jingħata lil pazjenti b’ sensittività eċċessiva magħrufa għal ezaflorinat tal- kubrit. jew għal xi komponenti ta ’ SonoVue.
SonoVue is contraindicated for use in patients with recent acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings), acute cardiac failure, Class III/ IV cardiac failure, or severe rhythm disorders.
SonoVue hu kontra- indikat għall- użu f’ pazjenti b’ sindrome koronarju akut riċenti jew mard kardijaku iskemiku instabbli, li jinkludi: infart mijokardjali li qed jevolvi jew li għadu għaddej, anġina tipika waqt li wieħed ikun jistrieħ fl- aħħar 7 ijiem, l- aggravament ta ’ sintomi kardijaċi fl- aħħar 7 ijiem, intervent arterjo- koronarju riċenti jew fatturi oħrajn li jissuġġerixxi instabilità klinika (pereżempju, deterjorament riċenti tas- sejbiet ta ’ l- ECG, tal- laboratorju jew kliniċi), kollass akut kardijaku, kollass akut ta ’ Klassi III/ IV, jew disturbi severi tar- rittmu.
SonoVue is contraindicated in patients known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg), uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome.
SonoVue hu kontra- indikat f’ pazjenti li hu magħruf li għandhom b’ shunts mil- lemin għax- xellug, pressjoni għolja pulmonari severa (pressjoni ta ’ l- arterja pulmonari > 90 mmHg), pressjoni għolja sistemika mhux ikkontrollata, u f’ pazjenti bis- sindrome ta ’ diffikultà respiratorja ta ’ l- adulti.
The safety and efficacy of SonoVue have not been established in pregnant and lactating women therefore, SonoVue should not be administered during pregnancy and lactation (see Section 4.6).
Is- sigurtà u l- effikaċja ta ’ SonoVue ma kienux stabbiliti f’ nisa tqal u li qed ireddgħu u għalhekk, SonoVue m’ għandux jingħata waqt it- tqala jew it- treddigħ (ara Sezzjoni 4. 6).
ECG monitoring should be performed in high-risk patients as clinically indicated.
Monitoraġġ bl- ECG għandu jsir f’ pazjenti li għandhom riskju għoli kif indikat klinikament.
It should be emphasised that stress echocardiography, which can mimic an ischaemic episode, could potentially increase the risk of SonoVue utilisation.
Il- fatt li l- ekokardjografija waqt l- istress, li tista ’ tkun tixbah lil episodju iskemiku, tista ’ potenzjalment iżżid ir- riskju ta ’ l- użu ta ’ SonoVue, irid ikun enfasizzat.
Moreover, ECG and blood pressure monitoring should be performed during SonoVue-enhanced echocardiography with a pharmacological stress (e. g. with dobutamine).
Għalhekk, jekk SonoVue ikun ser jintuża flimkien ma ’ ekokardjografija waqt l -- istress, il- pazjenti għandu jkollhom kundizzjoni stabbli li tkun ivverifikata mill- assenza ta ’ uġigħ fis- sider jew modifikazzjoni ta ’ l- ECG matul il- jumejn preċedenti.
3 Care should be taken in patients with ischaemic cardiac disease because in these patients allergy-like and/ or vasodilatory reactions may lead to life-threatening conditions.
3 Flimkien ma ’ dan, għandu jsir monitoraġġ bl- ECG u u tal- pressjoni tad- demm matul l- ekokardjografija mtejba permezz ta ’ SonoVue bi stress farmakoloġiku (eż. b’ dobutamine).
Emergency equipment and personnel trained in its use must be readily available.
Għandha tingħata attenzjoni f’ pazjenti b’ mard kardijaku iskemiku minħabba fi f’ dawn il- pazjenti, reazzjonijiet bħal dwk ta ’ l- allerġija jistgħu jwasslu għal kundizzjonijiet li huma ta ’ periklu għall- ħajja Tagħmir ta ’ l- emerġenza u staff imħarreġ fl- użu tiegħu iridu jkunu disponibbli fil- pront.
Caution is advised when SonoVue is administered to patients with clinically significant pulmonary disease, including severe chronic obstructive pulmonary disease.
Għandha tingħata attenzjoni meta SonoVue jingħata lil pazjenti b’ mard fil- pulmun li jkun klinikament sinifikanti, li jinkludi marda pulmonari ostruttiv kroniku sever.
It is recommended to keep the patient under close medical supervision during and for at least 30 minutes following the administration of SonoVue.
Hu rakkomandat li żżomm il- pazjent taħt superviżjoni medika mill- qrib, waqt u għall- inqas 30 minuta wara l- għoti ta ’ SonoVue.
Numbers of patients with the following conditions who were exposed to SonoVue in the clinical trials were limited, and therefore, caution is advisable when administering the product to patients with: acute endocarditis, prosthetic valves, acute systemic inflammation and/ or sepsis, hyperactive coagulation states and/ or recent thromboembolism, and end-stage renal or hepatic disease.
In- numru ta ’ pazjenti b’ dawn il- kundizzjonijiet li ġejjin, li kienu esposti għal SonoVue fil- provi kliniċi kien limitat, u għalhekk, għandha tingħata attenzjoni meta dan il- prodott jingħata lil pazjenti b ’: endokardite akuta, valvoli prostetiċi, infjammazzjoni sistemika akuta u/ jew sepsis, stati iperattivi tal- koagulazzjoni u/ jew tromboemboliżmu riċenti u mard tal- kliewi jew tal -- fwied li jkun fl- aħħar stadju.
SonoVue is not suitable for use in ventilated patients, and those with unstable neurological diseases.
SonoVue mhux adattat għall- użu f’ pazjenti li qegħdin fuq ventilazzjoni u dawk b’ mard newroloġiku mhux stabbli.
In animal studies, the application of echo-contrast agents revealed biological side effects (e. g. endothelial cell injury, capillary rupture) by interaction with the ultrasound beam.
Fi studji fuq l- annimali, l- applikazzjoni ta ’ sustanzi tal- kuntrast- eku żvelaw effetti sekondarji bijoloġiċi (eż. korriment endoteljali taċ- ċelluli, ftuq kapillari) permezz ta ’ interazzjoni b’ raġġ ultrasoniku.
Although these biological side effects have not been reported in humans, the use of a low mechanical index is recommended.
Għalkemm dawn l- effetti sekondarji bijoloġiċi ma kienux irrappurtati fil- bnedmin, l- użu ta ’ indiċi mekkaniku baxx hu rakkomandat.
No specific interaction studies have been performed.
Ma saru l- ebda studji speċifiċi dwar interazzjonijiet ma ’ prodotti oħra.
There was no apparent relationship with respect to occurrence of adverse events in the clinical studies for patients receiving various categories of the most common concomitant medications.
Ma kien hemm l- ebda relazzjoni apparenti fir- rigward ta ’ l -- avvenimenti avversi fl- istudji kliniċi għal pazjenti li rċivew kategoriji varji ta ’ l- iktar medikazzjonijiet komuni fl- istess ħin.
No clinical data on exposed pregnancies are available.
M’ hemmx tagħrif kliniku disponibbli fuq tqaliet esposti.
Animal studies do not indicate harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3 Preclinical safety data).
Studji fuq l- annimali ma jindikaw l- ebda effetti fir- rigward tat- tqala, fuq l- iżvilupp ta ’ l- embriju/ fetu, fuq il- ħlas jew l- iżvilupp wara t- twelid.
Caution should be exercised when prescribing to pregnant women.
(ara sezzjoni 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina).
It is not known if sulphur hexafluoride is excreted in human milk.
Mhux magħruf jekk ezaflorinat tal- kubrit. jitneħħiex fil- ħalib ta ’ l- omm.
Therefore, caution should be exercised when SonoVue is administered to breast-feeding women.
Għalhekk, għandha tingħata attenzjoni meta SonoVue jingħata lil nisa li qed ireddgħu.
On the basis of the pharmacokinetic and pharmacodynamic profiles, no or negligible influence is expected with the use of SonoVue on the ability to drive or use machines.
Fuq il- bażi tal- profil farmakokinetiku u farmakodinamiku, hu mistenni effett negliġibbli, jew l- ebda effett, bl- użu ta ’ SonoVue fuq il- ħila biex issuq jew tħaddem magni.
The undesirable effects reported with SonoVue were, in general, non-serious, transient and resolved spontaneously without residual effects.
L- effetti mhux mixtieqa rrappurtati bl- użu ta SonoVue kienu, b’ mod ġenerali, mhux serji, temporanji u li jfiequ b’ mod spontanju mingħajr effetti residwi.
In clinical trials, the most commonly reported adverse reactions are headache (2.3%), injection site reaction including bruising, burning and paraesthesia at the injection site (1.7%) and injection site pain (1.4%).
Fi provi kliniċi, l- iktar effetti mhux mixtieqa li kienu rrappurtati kienu uġigħ ta ’ ras (2. 3%), reazzjoni fis- sit ta ’ l- injezzjoni li jinkludu tbenġil, ħruq u parastesija fis- sit ta ’ l- injezzjoni (1. 7%) u uġigħ fis- sit ta ’ l- injezzjoni.
There were changes in ECG, blood pressure and in some laboratory parameters measured, but these were not deemed to be of clinical significance.
Kien hemm xi tibdil fl- ECG, fil- pressjoni tad- demm, u f’ xi parametri tal- laboratorju li ġew imkejla, iżda dawn ma kienux meqjusa li kienu ta ’ sinifikat kliniku.
4 The adverse reactions reported among 1788 adult patients in clinical studies are:
4 L- effetti avversi li kienu rrappurtati fost 1788 pazjent adult fl- istudji kliniċi kienu:
Body system Metabolism and nutrition disorders
Sistema tal- ġisem Disturbi fil- metaboliżmu u n - nutrizzjoni
Uncommon (> 1/ 1,000- < 1/ 100) Hyperglycaemia
Komuni Ħafna (> 1/ 1, 000 - < 1/ 100) Ipergliċemija
Nervous system disorders
Disturbi fis- sistema nervuża Uġigħ
Headache
ta ’ ras
Paraesthesia, dizziness, insomnia, taste perversion
Parastesija, sturdament, nuqqas ta ’ rqad, tibdil fit- togħma.
Eye disorders Vascular disorder Respiratory, thoracic and mediastinal disorders
Disturbi fl- għajnejn Disturbi vaskulari Disturbi respiratorji, toraċikċi u medjastinali
Vision blurred Vasodilatation Pharyngitis, sinus pain
Vista mċajpra Vasodilatazzjoni Farinġite, uġigħ fis- sinus
Abdominal pain Pruritus, rash erythematous
Uġigħ ta ’ żaqq Ħakk tal- ġilda, raxx eritematuż
Musculoskeletal, connective tissue and bone disorders
Disturbi muskolu- skeletrali u tal- connective tissue
General disorders and administration site conditions
Uġigħ fis- sit ta ’ l- injezzjoni,
Injection site pain, injection site reaction, including bruising, burning and paraesthesia at the injection site
kundizzjonijiet ta ’ mnejn jingħata
Chest pain, pain no organ system, asthenia
reazzjoni fis- sit ta ’ l- injezzjoni, system, astenja inkluż tbenġil, ħruq jew parastesija fis- sit ta ’ l - injezzjoni.
One case of sensory-motor paresis was reported.
Kien irrappurtat każ wieħed ta ’ paresi tal- mutur sensorju.
Post marketing Rare cases suggestive of hypersensitivity, which could include skin erythema, bradycardia, hypotension or anaphylactic shock have been reported following the injection of SonoVue.
Każijiet rari ji jissuġġerixxu s- sensittività eċċessiva, li jistgħu jinkludu eritema tal- ġilda, bradikardija, pressjoni tad- demm baxxa ħafna jew xokk anafilattiku, kienu rrappurtati wara injezzjoni ta ’ SonoVue.
In some of these cases, in patients with underlying coronary artery disease, bradycardia and hypotension were accompanied by myocardial ischemia and/ or myocardial infarctions.
F’ xi wħud minn dawn il- każijiet, il- pazjenti b’ mard bażiku ta ’ l- arterji koronarji, bradikardija u pressjoni tad- demm baxxa ħafna, kienu akkompanjati minn iskemija mijokardjali u/ jew infart mijokardjali.