qanastek/EMEA-V3 huggingface dataset:
DO NOT SHAKE THE VIAL.
TĦAWWADX IL- KUNJETT.
The solution should be clear after the powder is dissolved.
Is- soluzzjoni għandha tkun ċara wara li jinħall it- trab.
If the solution is cloudy or hazy, do not inject it.
Jekk is- soluzzjoni tkun imdardra jew imċajpra, tinjettahiex.
Notify your pharmacy and request a replacement vial.
Għarraf lill- ispiżerija tiegħek u itlob kunjett ieħor.
Do not throw the vial away because the pharmacy may request that you return it.
Tarmix il- kunjett għax l- ispiżerija tista ’ titolbok biex tirritornah.
PREPARING THE INJECTION
51 IL- PREPARAZZJONI TA ’ L- INJEZZJONI
Securely grasp the vial containing the SOMAVERT reconstituted solution, vial adapter and syringe assembly.
Aqbad sod il- kunjett bis- soluzzjoni rikostitwita ta ’ SOMAVERT, l- adapter tal- kunjett u s- siringa.
Carefully turn the vial, adapter and syringe assembly upside down.
Dawwar bl- attenzjoni l- kunjett, l- adapter u s- siringa ta ’ taħt fuq.
Bring to eye level.
Ġibhom fil- livell ta ’ għajnejk.
As before, slide one hand carefully down the vial so that with your thumb and forefinger you can securely grasp the neck of the vial, and with your other fingers, the upper portion of the syringe.
Bħal qabel, żerżaq ’ l isfel b’ attenzjoni id waħda tul il- kunjett b’ mod li b’ sebgħek il- kbir u sebgħek il- werrej inti tkun tista ’ taqbad sod l- għonq tal- kunjett, u bis- swaba ’ l- oħra, il- parti ta ’ fuq tas - siringa.
With the other hand, slowly pull the syringe plunger down to withdraw the full contents of the vial (1 ml).
B’ idek l- oħra, iġbed ’ l isfel bil- mod il- planġer tas- siringa biex tiġbed il- kontenut sħiħ tal - kunjett (1 ml).
Visually inspect the syringe for air bubbles.
Eżamina viżwalment is- siringa għall- bżieżaq ta ’ l- arja.
If bubbles are present, tap the syringe barrel until the bubbles rise to the top of the syringe.
Jekk ikun hemm il- bżieżaq, tektek il- bettija tas- siringa sakemm il- bżieżaq jitilgħu fil- parti ta ’ fuq tas- siringa.
Carefully push the plunger up to eject only the air bubbles back into the vial.
Imbotta bl- attenzjoni l- planġer biex tixħet biss il- bżieżaq ta ’ l- arja lura għal ġol- kunjett.
Recheck that 1 ml of the solution remains in the syringe.
Erġa ’ iċċekkja li 1 ml ta ’ solvent jibqa ’ fis- siringa.
Carefully turn the vial containing the SOMAVERT reconstituted solution, adapter and syringe assembly and place them upright on a clean surface.
Dawwar bl- attenzjoni l- kunjett bis- soluzzjoni rikostitwita ta ’ SOMAVERT, l- adapter u s- siringa u poġġihom weqfin fuq wiċċ nadif.
1 ml
1 ml Figura 9
Figure 9
9).
Once reconstituted, SOMAVERT should be used immediately.
Ladarba jiġi rikostitwit, SOMAVERT għandu jintuża immedjatament.
Please proceed to “STEP 2.
Jekk jogħġbok mur għal “ IT- TIENI PASS.
GIVING THE INJECTION”.
L- GĦOTI TA ’ L- INJEZZJONI ”.
b) NON VIAL ADAPTER METHOD
b) METODU MINGĦAJR L- ADAPTER TAL- KUNJETT
Getting Started
Il- Bidu
• Wash your hands thoroughly. • Collect one vial of powder (SOMAVERT) and one vial of solvent (Water for Injections), one 3-ml syringe with a 21-gauge, 1-inch detachable needle, one standard 1 ml insulin syringe, alcohol or antiseptic swabs and a proper disposal container for used needles. • Inspect the expiry dates on both the vial label and the syringe label.
• Aħsel idejk sew • Iġbor kunjett ta ’ trab (SOMAVERT) u kunjett ta ’ solvent (Ilma għall- injezzjonijiet), siringa ta ’ 3 ml b’ kejl ta ’ 21, labra li tinqala ’ ta ’ pulzier, siringa ta ’ l- insulina standard ta ’ 1 ml,, swobs (imsielaħ taċ- ċraret) bl- alkoħol jew antisettiċi u kontenitur xieraq sabiex fih jintremew il- labar użati. • Ara d- dati ta ’ skadenza kemm fuq it- tikketta tal- kunjett u kemm fuq it- tikketta tas- siringa.
Preparing the SOMAVERT dose for injection
52 Il- preparazzjoni tad- doża ta ’ SOMAVERT għall- injezzjoni
Remove the protective plastic caps from the tops of both vials.
Neħħi l- għotjien protettivi tal- plastik mill- parti ta ’ fuq taż- żewġ kunjetti.
If the stoppers are touched or otherwise contaminated, you must clean them with an antiseptic or alcohol swab before inserting a needle through the stopper.
Jekk it- tappijiet jintmessu jew jiġu kontaminati b’ xi mod ieħor, dawn għandhom jitnaddfu bi swobs (imsielaħ taċ- ċraret) bl- alkoħol jew antisettiċi, qabel ma wieħed idaħħal il- labra ġot- tapp tal- gomma.
49 Carefully remove the cap from the needle of the larger syringe (3 ml) and set the cap aside.
Neħħi b’ attenzjoni l- għatu mil- labra tas- siringa l- kbira (3 ml) u warrbu.
This is the solvent syringe.
Din hija s- siringa għas- solvent.
Pull the plunger of the solvent syringe down to the1 ml mark.
Iġbed il- planġer tas- siringa tas- solvent sal- marka ta ’ 1 ml.
With one hand, securely hold the vial of solvent and, with the other hand, insert the needle of the solvent syringe straight through the center of the rubber stopper and deep into the vial.
B’ id waħda, żomm sod il- kunjett u b’ idek l- oħra, daħħal il- labra tas- siringa tas- solvent dritt fin- nofs tat- tapp tal- gomma u fil- fond ġol- kunjett.
1)
Imbotta bil- mod il- planġer sakemm l- arja tiġi injettata ġol- kunjett (Fig 1).
Securely grasp the solvent vial and syringe assembly, with the needle still deeply inserted into the vial.
Aqbad b’ mod sod il- kunjett tas- solvent u s- siringa fl- intier tagħha, bil- labra għadha mdaħħla fil - fond ġol- kunjett.
Carefully turn the vial and syringe assembly upside down.
Aqleb b’ attenzjoni l- kunjett u s- siringa ta ’ taħt fuq.
2)
Żommhom fil - livell ta ’ għajnejk (Fig 2).
3.
Fig 3 53 3.
Slide one hand carefully down the solvent vial so that with your thumb and forefinger you can securely grasp the neck of the vial, and with your other fingers, the upper part of the syringe.
Żerżaq ’ l isfel bl- attenzjoni id waħda tul il- kunjett tas- solvent b’ mod li b’ sebgħek il- kbir u b’ sebgħek il- werrej inti tkun tista ’ taqbad b’ mod sod għonq il- kunjett, u bis- swaba ’ l- oħra taqbad il- parti ta ’ fuq tas- siringa.
With the other hand, slowly pull the syringe plunger down to slightly past the 1 ml mark.
B’ idek l- oħra iġbed bil- mod il- planġer tas- siringa kemm taqbeż il- marka ta ’ 1 ml.
50 Examine the solution in the syringe for air bubbles.
Eżamina s- soluzzjoni fis- siringa għall- bżieżaq ta ’ l- arja.
If bubbles are present, tap the syringe barrel until the bubbles rise to the top of the syringe.
Jekk ikun hemm dawn il- bżieżaq, tektek il- bettija tas- siringa sakemm il- bżieżaq jitilgħu fil- parti ta ’ fuq tas- siringa.
Carefully push the plunger up to eject only the air bubbles back into the vial.
Imbotta bl - attenzjoni l- planġer tas- siringa biex il- bżieżaq ta ’ l- arja biss jinxteħtu barra u lura fil- kunjett.
(Fig 3)
Erġa ’ iċċekkja li jibqa ’ 1 ml ta ’ solvent fis- siringa, imbagħad iġbed il- labra mill- kunjett.
Fig 4
(Fig 3)
4.
Fig 4 4.
Insert the needle of the solvent syringe straight through the stopper of the vial with the powder (SOMAVERT).
Daħħal il- labra tas- siringa tas- solvent dritt minn ġot- tapp tal- kunjett ta ’ trab (SOMAVERT).
Tilt the syringe to the side and gently inject the solvent down the inner side of the vial of SOMAVERT.
Mejjel is- siringa fuq il- ġenb tagħha u bil- ħlewwa injetta s- solvent tul in- naħa ġewwinija tal - kunjett ta ’ SOMAVERT.
When the solvent syringe is empty, withdraw it from the vial.
Meta s- siringa tas- solvent tkun żvujtat, iġbidha lura mill- kunjett.
(Fig 4)
Armi l- kunjett tas- solvent, is- siringa u l- labra skond l- istruzzjonijiet tal- fornitur tal- kura tas- saħħa u bil- mod kif indikat mill- istess (Fig 4).
Hold the vial of SOMAVERT upright between your hands and gently roll it to dissolve the powder.
Żomm il- kunjett ta ’ SOMAVERT wieqaf bejn idejk u irrumblah bil- mod sabiex iddewweb it - trab.
DO NOT SHAKE THE VIAL.
MA GĦANDEKX TĦAWWAD IL- KUNJETT.
The solution should be clear after the powder is dissolved.
Il- likwidu għandu jkun ċar wara li t- trab ikun imdewweb.
If the solution is cloudy or hazy, do not inject it.
Jekk il- likwidu mdewweb ikun imdardar jew imċajpar, tinjettahx.
Notify your pharmacy and request a replacement vial.
Avża lill - ispiżerija tiegħek u itlob kunjett ieħor minflok.
Do not throw the vial away because the pharmacy may request that you return it.
Tarmix l- ewwel kunjett għax jista ’ jagħti l- każ li tiġi mitlub/ a tirritornah lill- ispiżerija.
5)
Injetta SOMAVERT immedjatement (Fig 5).
PREPARING THE INJECTION
54 IL- PREPARAZZJONI TA ’ L- INJEZZJONI
Clean the rubber stopper of the vial of SOMAVERT with an antiseptic or alcohol swab.
Naddaf it- tapp tal- gomma tal- kunjett ta’ SOMAVERT bi swobb (imsielaħ taċ- ċraret) bl- alkoħol jew antisettiku.
Remove the cap from the syringe (1 ml).
Neħħi l- għatu tas- siringa (1 ml).
Pull the syringe plunger down to the 1-ml mark.
Iġbed il- planġer tas- siringa sal- livell ta ’ 1 ml.
With one hand, securely hold the vial.
B’ id waħda żomm sod il- kunjett.
With the other hand, insert the needle straight through the center of the rubber stopper and deep into the vial.
Bl- id l- oħra daħħal il- labra fin- nofs tat- tapp tal- gomma u fil - fond tal- kunjett.
Gently push the plunger until the air is injected into the vial.
Imbotta bil- mod il- planġer tas- siringa sakemm l- arja tiġi injettata ġol- kunjett.
Securely grasp the vial and syringe assembly, with the needle still deeply inserted into the vial.
B’ mod sod aqbad il- kunjett u s- siringa fl- intier tagħha, waqt li l- labra tkun għadha mdaħħla fil - fond fil- kunjett.
Bring to eye level.
Żommhom fil- livell ta ’ għajnejk.
(Fig.
(Fig 6)
As before, slide one hand carefully down the vial so that with your thumb and forefinger you can securely grasp the neck of the vial, and with your other fingers, the upper portion of the syringe.
Bħal qabel, żerżaq ’ l isfel b’ attenzjoni id waħda tul il- kunjett b’ mod li b’ sebgħek il- kbir u b’ sebgħek il- werrej inti tkun tista ’ taqbad b’ mod sod għonq il- kunjett, u bis- swaba ’ l- oħra taqbad il- parti ta ’ fuq tas- siringa.
With the other hand, slowly pull the syringe plunger down to withdraw the full contents of the vial (1 ml).
B’ idek l- oħra iġbed bil- mod il- planġer tas- siringa sabiex tiżvojta l- kontenut kollu tal- kunjett (1 ml).
To keep the needle tip within the liquid, you may have to slowly back it out of the stopper as you draw out the liquid.
Sabiex iżżomm il- ponta tal- labra fil- likwidu, jista ’ jagħti l- każ li jkollok tiġbidha lura bil- mod mit- tapp waqt li tkun qed tiġbed il- likwidu ’ l barra.
If bubbles are present, tap the syringe barrel until the bubbles rise to the top of the syringe.
Jekk ikun hemm dawn il- bżieżaq, tektek fuq il- bettija tas- siringa sakemm il- bżieżaq jitilgħu fil- parti ta ’ fuq tas- siringa.
Carefully push the plunger up to eject only the air bubbles back into the vial.
Imbotta bl - attenzjoni l- planġer tas- siringa ’ l fuq biex il- bżieżaq ta ’ l- arja biss jinxteħtu ’ l barra u lura fil - kunjett.
Recheck that 1 ml of the solution remains in the syringe, then withdraw the needle from the vial.
Wara li tkun ċert li 1 ml tas- soluzzjoni jibqa ’ ġos- siringa, iġbed lura l- labra mill- kunjett.
Recap the needle as directed by your health care provider to minimise accidental injury while preparing the site for injection.
Erġa ’ poġġi t- tapp tal- labra f’ postu skond l- istruzzjonijiet tal- fornitur tal- kura tas- saħħa tiegħek, sabiex tiġi mnaqqsa l- possibilità ta ’ korriment aċċidentali waqt li wieħed ikun qed jipprepara l - parti li tkun se tiġi injettata.
7)
(Fig 7).
STEP 2.
55 IT- TIENI PASS.
GIVING THE INJECTION
L- GĦOTI TA ’ L- INJEZZJONI
Choose an injection site on the upper arm, upper thigh, abdomen or buttocks.
Agħżel post għall- injezzjoni fil- parti ta ’ fuq ta ’ l- id, fil- parti ta ’ fuq tal- koxxa, fiż- żaqq jew fil - warrani.
Always move on to a different area with each day’s injection.
Kull ġurnata li trid tingħata injezzjoni, dejjem biddel il- parti fejn se tinjetta.
It may be helpful to keep a record of each day’s injection site as you take your daily dose of SOMAVERT.
Tista ’ tkun ta ’ għajnuna jekk iżżomm nota tal- parti tal- ġisem fejn tkun ingħatat l- injezzjoni tal- ġurnata hekk kif tieħu d- doża tiegħek ta ’ kuljum ta ’ SOMAVERT.
Do not use an area that has a rash or broken skin, or is bruised or lumpy.
Tużax parti fejn hemm raxx jew qasma fil - ġilda jew li għandha tbenġila jew għoqda.
Clean the site with an antiseptic or alcohol swab, let the skin dry before injecting the product.
Naddaf il- parti bi swobb (imsielaħ taċ- ċraret) bl- alkoħol jew antisettiku u ħalli l- ġilda tinxef qabel tinjetta l- prodott.
Uncap the needle if previously recapped.
Neħħi l- għatu tal- labra jekk dan ikun tqiegħed f’ postu qabel.
With one hand, gently pinch up the skin at the site of injection.
B’ id waħda oqros il- ġilda ’ l fuq fil- parti li tkun se tinjetta.
(Fig.
Żomm is- siringa bl- id l- oħra u b’ moviment wieħed lixx, daħħal il- labra kompletament ’ l isfel ġol- ġilda (f’ angolu ta ’ 90 grad) (Fig.
Be sure to keep the needle all the way into the skin while you slowly push the syringe plunger down until the barrel is empty.
Kun ċert/ a li żżomm il- labra kompletament fil- ġilda waqt li bil- mod timbotta il- planġer tas - siringa sakemm il- bettija tagħha tiżvojta.
(Fig.
Tkomplix toqros il- ġilda u oħroġ il- labra ’ l barra (Fig.
c.
56
Do not rub the injection area.
ċ Togħrokx il- parti li tkun ġiet injettata.
A small amount of bleeding may occur.
Jista ’ jkun hemm xi telf żgħir ta ’ demm.
If necessary, apply a clean, dry cotton swab over the area and press gently for 1 or 2 minutes, or until the bleeding has stopped.
Jekk ikun hemm bżonn, poġġi biċċa tajjara niexfa u nadifa fuq il- parti li ġiet injettata u agħfas bil- mod għal minuta jew tnejn jew sakemm jieqaf id- demm.
C)
Ċ).
Disposing of Supplies
Ir- Rimi ta ’ l- Oġġetti
The syringe and needle should NEVER be reused.
Is- siringa u l- labra QATT ma għandhom jerġgħu jintużaw.
Dispose of the needle and syringe as instructed by your doctor, nurse or pharmacist.
Armi l- labra u s- siringa skond kif indikat mit- tabib, l- infermier jew l- ispiżjar tiegħek.
All questions should be handled by a doctor, nurse or pharmacist familiar with SOMAVERT.
Id- domandi kollha għandhom jiġu indirizzati lil tabib, infermier jew spiżjar li hu familjari ma ’ SOMAVERT.
Blister (PVC/ PVDC)
Folja (PVC/ PVDC)
What is Sonata?
X’ inhu Sonata?
Sonata is a medicine that contains the active substance zaleplon.
Sonata huwa mediċina li fiha s- sustanza attiva zaleplon.
It is available as capsules (white and brown:
Huwa disponibbli f’ kapsuli (bojod u kannella:
5 mg; white:
5 mg; bojod:
What is Sonata used for?
Għal xiex jintuża Sonata?
Sonata is used for the treatment of adults with insomnia who have difficulty falling asleep.
Sonata jintuża fit- trattament ta ’ adulti li jbatu mill- insonnja li jsibuha diffiċli biex jorqdu.
It is used only when the insomnia is severe, disabling or causing extreme distress.
Jintuża biss meta l- insonnja tkun severa, tindebolixxi jew tikkawża għeja u tbatija estrema.
How is Sonata used?
Kif jintuża Sonata?
Treatment with Sonata should be as short as possible and should last for no more than two weeks.
It- trattament b’ Sonata għandu jkun qasir kemm jista ’ jkun u m’ għandux idum aktar minn ġimagħtejn.
Sonata is taken immediately before going to bed, or after the patient has gone to bed and is having difficulty falling asleep.
Sonata jittieħed immedjatament qabel ma wieħed jidħol fis- sodda jew wara li l- pazjent ikun daħal fis - sodda u jkun qiegħed isibha diffiċli biex jorqod.
The maximum total daily dose of Sonata is 10 mg.
Id- doża rakkomandata hija 10 mg, għajr għall- anzjani jew pazjenti b’ mard tal- fwied ħafif jew moderat, li għandhom jieħdu 5 mg Id- doża massima totali kuljum ta ’ Sonata hija ta ’ 10 mg.
Patients should not take a second dose within a single night.
Pazjenti m’ għandhomx jieħdu t- tieni doża fi żmien lejl.
No food should be eaten with or shortly before taking Sonata, because it can reduce the medicine’ s effects.
Il- pazjenti m’ għandhomx jieklu meta jieħdu Sonata u lanqas ftit qabel ma jagħmlu dan, minħabba li dan jista ’ jirriżulta fit- tnaqqis tal- effetti tal- mediċina.
Sonata must not be taken by children or by patients who have severe liver or kidney problems.
Sonata m’ għandux jingħata lit- tfal jew lill- pazjenti bi problemi severi fil- fwied jew fil- kliewi.
How does Sonata work?
Kif jaħdem Sonata?
The active substance in Sonata, zaleplon, belongs to a group of medicines that are related to the benzodiazepines.
Is- sustanza attiva f’ Sonata, zaleplon, tapartjeni għal grupp ta ’ mediċini li huma relatati mal - benzodiazepines.
Zaleplon is chemically different from the benzodiazepines, but it acts on the same receptors in the brain.
Zaleplon huwa kimikament differenti mill- benzodiazepines, iżda jaħdem fuq l- istess riċetturi fil- moħħ.
It is a gamma-amino butyric acid (GABA) receptor agonist, which means that it attaches to the receptors for the neurotransmitter GABA and activates them.
Huwa agonist tar- riċetturi tal- aċdu butiriku gamma- amino (GABA - gamma- amino butyric acid receptor agonist), li jfisser li jeħel mar- riċetturi tan- newrotrasmettituri tal- GABA u jattivahom.
Neurotransmitters such as GABA are chemicals that allow nerve cells to communicate with each other.
Newrotrasmettituri bħal GABA huma kimiċi li jippermettu liċ- ċelluli tan- nervituri jikkomunikaw bejniethom.
In the brain, GABA is involved in bringing about sleep.
Fil- moħħ, GABA jistimula l- irqad.
By activating its receptors, zaleplon increases GABA’ s effects, which encourages sleep.
Billi jattiva r- riċetturi tiegħu, zaleplon iżid l- effetti ta ’ GABA, li jinkorraġġixxu l- irqad.
The powder in Sonata capsules is coloured with an intense dark blue dye, to prevent it being given to someone without their knowledge.
It- trab fil- kapsuli Sonata huwa kkulurit b’ żebgħa blu skura qawwija, biex jiġi evitat li jingħata lil xi ħadd mingħajr ma jkun jaf.
How has Sonata been studied?
Kif ġie studjat Sonata?
Sonata has been studied in a total of 14 studies, involving nearly 3,500 adults and elderly patients.
Sonata ġie studjat f’ total ta ’ 14- il studju, li involvew kważi 3, 500 adult u pazjenti anzjani.
Five of these studies were comparative:
Ħamsa minn dawn l- istudji kienu komparattivi:
Sonata was compared with placebo (a dummy treatment) or with zolpidem or triazolam (other medicines used in insomnia).
Sonata tqabbel ma ’ plaċebo (trattament finta) jew ma ’ zolpidem jew triazolam (mediċini oħra użata fl- insonnja).
The main studies lasted for two to four weeks.
L- istudji ewlenin damu bejn ġimagħtejn u erba ’ ġimgħat.
The main measure of effectiveness was the time taken to fall asleep.
Il- kejl ewlieni tal- effikaċja kien iż- żmien meħud minn pazjenti sabiex jorqdu.
Some studies also looked at the time spent asleep and sleeping patterns.
Xi studji eżaminaw ukoll iż- żmien li damu reqdin il- pazjenti u kif kienu qegħdin jorqdu.
What benefit has Sonata shown during the studies?
X’ benefiċċji wera Sonata matul l- istudji mwettqa?
The time taken to fall asleep was reduced in adults taking Sonata 10 mg, and the effects were maintained for up to four weeks.
Iż- żmien sakemm jorqdu l- pazjenti naqas f’ adulti li kienu qegħdin jieħdu Sonata 10 mg, u l- effetti baqgħu hekk sa ’ erba ’ ġimgħat wara.
In elderly patients, the time taken to fall asleep was often decreased with Sonata 5 mg and was always decreased with Sonata 10 mg, when they were compared with placebo in the two-week studies.
F’ pazjenti anzjani, iż- żmien li damu biex jorqdu ħafna drabi naqas b’ Sonata 5 mg u naqas dejjem b’ Sonata 10 mg, meta mqabbel mal- plaċebo fl- istudji ta ’ ġimagħtejn.
Sonata 10 mg was more effective than placebo in decreasing the time taken to fall asleep and increasing time spent asleep during the first half of the night.
Sonata 10 mg kien iktar effikaċi mill- plaċebo fit- tnaqqis taż- żmien li damu biex jorqdu u fiż- żieda taż - żmien ta ’ irqad matul l- ewwel nofs tal- lejl.
Sonata also preserved sleep patterns in the studies that measured the time spent in different stages of sleep.
Sonata żamm ukoll il- mod kif kienu qegħdin jorqdu fl- istudji li kejlu ż- żmien fl- istadji differenti tal - irqad.
What is the risk associated with Sonata?
X’ inhu r- riskju assoċjat ma ’ Sonata?
The most common side effects with Sonata (seen in between 1 and 10 patients in 100) are amnesia (memory problems), paraesthesia (unusual sensations like pins and needles), somnolence (sleepiness) and dysmenorrhoea (painful menstruation).
L- aktar effetti sekondarji komuni b’ Sonata (li dehru f’ bejn 1 u 10 pazjenti minn kull 100) huma amnesija (problemi bil- memorja), parestesija (sensazzjonijiet anormali bħal tingiż), ħedla tan- ngħas u dismenorrea (mestrwazzjoni li tikkawża l- uġigħ).
For the full list of all side effects reported with Sonata, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrapportati b’ Sonata, ara l- Fuljett ta ’ Tagħrif.
Sonata should not be used in people who may be hypersensitive (allergic) to zaleplon or any of the other ingredients.
Sonata m’ għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal zaleplon jew għal xi ingredjenti oħra tiegħu.
It must not be used in patients with severe liver or kidney problems, sleep apnoea syndrome (frequent interruption of breathing during sleep), myasthenia gravis (a disease causing muscle weakness) or severe respiratory insufficiency (breathing disorders), or in patients under 18 years of age.
M’ għandux jintuża f’ pazjenti bi problemi severi fil- fwied jew il- kliewi, bis - sindromu ta ’ apnea tal- irqad (waqfien frekwenti tan- nifs waqt l- irqad), mijastenija gravis (marda li tikkawża indeboliment tal- muskoli) jew insuffiċjenza respiratorja severa (disturbi tan- nifs), jew f’ pazjenti ta ’ taħt it- 18- il sena.
Why has Sonata been approved?
Għaliex ġie approvat Sonata?
The Committee for Medicinal Products for Human Use (CHMP) decided that Sonata’ s benefits are greater than its risks for the treatment of patients with insomnia who have difficulty falling asleep, when the disorder is severe, disabling or subjecting the individual to extreme distress.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Sonata huma akbar mir- riskji tiegħu għat- trattament ta ’ pazjenti bl- insonnja li jsibuha diffiċli biex jorqdu, meta id- disturb ikun sever, b’ indeboliment jew li jikkawża għeja kbira lill- individwi.
The Committee recommended that Sonata be given marketing authorisation.
Il - Kumitat irrakkomanda li Sonata jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Sonata:
Tagħrif ieħor dwar Sonata:
The European Commission granted a marketing authorisation valid throughout the European Union for Sonata on 12 March 1999.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq fl- Unjoni Ewropea kollha għal Sonata fit- 12 ta ’ Marzu 1999.
The marketing authorisation was renewed on 12 March 2004 and on 12 March 2009.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 12 ta ’ Marzu 2004 u fit- 12 ta ’ Marzu 2009.
The marketing authorisation holder is Meda AB.
Id- detentur tal- awtorizzazzjoni għat- tqegħid fis- suq huwa Meda AB.
The full EPAR for Sonata is available here.
L- EPAR sħiħ għal Sonata jista ’ jiġi kkonsultat hawn.
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNESS I KARATTERISTIĊI TAL- PRODOTT FIL- QOSOR
Sonata 5 mg hard capsules
Sonata 5 mg kapsuli iebsin
Each capsule contains 5 mg of zaleplon.
Kull kapsula fiha 5 mg ta ’ zaleplon
Lactose monohydrate 54 mg.
Sustanzi mhux attivi: lactose monohydrate 54 mg.
Capsule, hard.
Kapsuli iebsin.
Capsules have an opaque white and opaque light brown hard shell with gold band, “ W” and the strength “ 5 mg”.
Kapsuli li għandhom il- qoxra iebsa ta ’ kulur abjad opak, u kanella ċar opak, b’ ċirku ta ’ kulur tad - deheb, “ W ” u d- doża “ 5 mg ”.
Sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep.
Sonata hi maħsuba għat- trattament ta ’ pazjenti li jbatu minn problemi ta ’ insomnija u li jbatu biex jorqdu.
It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.
Hija maħsuba għal dawk li għandhom il- problema tant kbira, li ġġiehelhom jħossu li għandhom xi diżabilità, jew iħossuhom mdejqin ħafna.
For adults, the recommended dose is 10 mg.
Għall- adulti hija rrakkomandata doża ta ’ 10 mg.
Treatment should be as short as possible with a maximum duration of two weeks.
It- trattament għandu jingħata għall- anqas żmien possibli, u għal mhux aktar minn ġimagħtejn.
Sonata can be taken immediately before going to bed or after the patient has gone to bed and is experiencing difficulty falling asleep.
Sonata tista ’ tittieħed immedjatament qabel l- pazjent imur jorqod jew wara li jkun daħal jorqod u isibha diffiċli biex jorqod.
As administration after food delays the time to maximal plasma concentration by approximately 2 hours no food should be eaten with or shortly before intake of Sonata.
Jekk titieħed wara l- ikel, il- konċentrazzjoni massima tal- plażma tkun ittardjata b’ sagħtejn, iżda l- ammont li jiġi assorbit b’ kollox ma jinbidilx.
The total daily dose of Sonata should not exceed 10 mg in any patient.
L- ebda pazjent m’ għandu jieħu doża ta ’ aktar minn 10 mg ta ’ Sonata kuljum.
Patients should be advised not to take a second dose within a single night.
Il- pazjenti għandhom ikunu avżati biex ma jieħdux doża oħra f’ lejl wieħed
Elderly Elderly patients may be sensitive to the effects of hypnotics; therefore, 5 mg is the recommended dose of Sonata.
Pazjenti anzjani Pazjenti anzjani jistgħu jkun sensittivi għall- effetti ta ’ ipnotiċi; għalhekk hu rakkomandat li d- doża ta ’ Sonata tkun ta ’ 5 mg.
Paediatric patients Sonata is contraindicated in children (see section 4.3).
Tfal Sonata mhux maħsub biex jintuża fit- tfal
For severe hepatic impairment see section 4.3.
Insuffiċjenza tal- fwied Pazjenti bi problema epatika kemm jekk din tkun ħafifa kif ukoll jekk tkun moderata għandhom jiġu mogħtija doża ta ’ Sonata 5mg, għaliex ir- rata tal- eliminazzjoni f’ dawn il- pazjenti hija inqas. (ara sezzjoni 4. 3)
2 Renal impairment No dosage adjustment is required in patients with mild to moderate renal insufficiency, because Sonata pharmacokinetics is not altered in such patients.
L- ebda aġġustament fid- doża ma hi meħtieġa għal pazjenti li għandhom insuffiċjenza renali li tkun bejn ħafifa u moderata, għaliex il- farmakokinetiċi ta ’ Sonata ma jitbidlux f’ pazjenti bħal dawn.
Severe renal impairment is contraindicated (see section 4.3.).
Għal insuffiċjenza renali gravi ara sezzjoni 4. 3( Kontra- indikazzjonitiet).
Hypersensitivity to the active substance or to any of the excipients Severe hepatic impairment Severe renal impairment Sleep apnoea syndrome Myasthenia gravis Severe respiratory insufficiency Children (under 18 years of age)
Insuffiċjenza epatika gravi Insuffiċjenza renali gravi Sintomi ta ’ waqfien tan- nifs għal xi ħin waqt l- irqad Myasthenia gravis Insuffiċjenza respiratorja gravi Tfal (taħt 18- il sena)
Complex behaviours such as “ sleep-driving” (i. e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported in patients taking sedative- hypnotics.
Imġieba kumplessa bħal “ irqad waqt is- sewqan ” (i. e., sewqan waqt li persuna ma tkunx imqajma sew wara t- teħid ta ’ sedattiv- ipnotiku, b’ amnesija għal każ) ġiet rapportata f’ pazjenti li jieħdu sedattivi - ipnotiċi.
These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic experienced persons.
Dawn il- każijiet jistgħu jseħħu kemm f’ persuni li jkunu diġà ħadu xi sedattiv- ipnotiku fil - passat u f’ dawk li jkunu qed jieħdu sedattiv- ipnotiku għall- ewwel darba.
Although behaviours such as sleep-driving may occur with a sedative-hypnotic alone at therapeutic doses, the use of alcohol and other central nervous system (CNS) depressants with sedative-hypnotics appears to increase the risk of such behaviours, as does exceeding the maximum recommended dose.
Għalkemm imġieba bħal irqad waqt is- sewqan tista ’ sseħħ b’ sedattiv- ipnotiku waħdu f’ dożi terapewtiċi, l- użu ta ’ alkoħol u dipressanti tas- sistema ċentrali tan- nervituri (SĊN) ma ’ sedattivi- ipnotiċi jidher li jista ’ jgħolli r- riskju ta ’ mġieba bħal din, kif ukoll meta wieħed jaqbeż id- doża massima rakkomandata.
Due to the risk to the patient and the community, discontinuation of zaleplon is recommended for patients who report a “ sleep-driving” episode.
Minħabba r- riskju għall- pazjent u ghallkomunità, il- waqfien ta ’ zaleplon huwa rakkomandat għal pazjenti li jirraportaw episodji ta ’ “ irqad waqt is- sewqan ”.
Other complex behaviours (e. g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic.
Imġieba kumplessa oħra (e. g., preparazzjoni u teħid ta ’ l- ikel, isiru telefonati, atti sesswali) ġew rapportati f’ pazjenti li ma kinux kompletament imqajjmin wara li ħadu sedattiv- ipnotiku.
As with sleep-driving, patients usually do not remember these events.
Bħal fil- każ ta ’ l- irqad waqt is- sewqan, il- pazjenti ġeneralment ma jibqgħux jiftakru dawn l- episodji.
Severe anaphylactic/ anaphylactoid reactions have been reported with the use of sedative-hypnotics, including zaleplon.
Reazzjonijiet anafilattiċi/ anafilattojdi ġew irrapportati bl- użu ta ’ sedattivi- ipnotiċi, li jinkludi zaleplon.
Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zaleplon.
Każijiet ta ’ anġjoedema li jinvolvi l- ilsien, glottide jew larinġi ġew rapportati f’ pazjenti wara li ħadu l - ewwel doża jew dawk sussegwenti ta ’ sedattivi- ipnotiċi, li jinkludu zaleplon.
Some patients taking sedative-hypnotics have had additional symptoms such as dyspnoea, throat closing, or nausea and vomiting.
Xi pazjenti li jieħdu sedattivi- ipnotiċi kellhom sintomi oħra bħal dispnea, griżmejn jingħalqu, jew dardir u remettar.
Some patients have required medical therapy in the emergency department.
Xi pazjenti kienu jinħtieġu terapija medika fid- dipartiment ta ’ l- emerġenza.
If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal.
Jekk anġjoedema tinvolvi l - ilsien, glottide jew larinġi, jista ’ jkun hemm impediment fil- passaġġi ta ’ l- arja.
Patients who develop angioedema after treatment with zaleplon should not be rechallenged with the active substance.
Pazjenti li jiżvillupaw anġjoedema wara trattament b’ zaleplon m’ għandhomx jingħataw mill- ġdid din is- sustanza attiva.
Insomnia may represent an underlying physical or psychiatric disorder.
Problemi ta ’ rqad jistgħu jiġu kkaġunati minħabba xi disabilità moħbija jew fiżika jew ta ’ natura psikjatrika.
Insomnia that persists or worsens after a short course of zaleplon treatment may indicate a need to re-evaluate the patient.
Problemi ta’ rqad li jippersistu jew jiżdiedu wara kors qasir ta ’ trattament taż- zaleplon jista ’ jfisser li hemm il- bżonn ta ’ evalwazzjoni mill- ġdid tal- pazjent.
Due to zaleplon’ s short plasma half-life, alternative therapy should be considered if early morning awakening is experienced.
Minħabba li zaleplon jonqos bin- nofs f’ qasir żmien fil- plażma (short plasma half- life), terapija alternattiva għandha tkun ikkunsidrata jekk il- pazjent iqum kmieni fil- għodu.
Patients should be advised not to take a second dose within a single night.
Il- pazjenti għandhom ikunu imwissija biex ma jieħdux it- tieni doża f’ lejl wieħed.
(See section 4.5)
Meta Sonata tittieħed flimkien ma ’ prodotti mediċinali oħra magħrufa li jinfluwenzaw CYP3A4, hu mistenni li jkun hemm bidla fil- konċentrazzjoniet tal- plażma ta ’ zaleplon (Ara sezzjoni 4. 5).
Tolerance Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines and benzodiazepine-like agents may develop after repeated use for a few weeks.
Toleranza Jekk l- użu jkun ripetut għal ftit ġimgħat, jista ’ jirriżulta li l- benżodjażepin li jaħdmu fi żmien qasir, u prodotti oħra simili għall- benżodjażepin, jitilfu xi ftit tal- effikaċja għall- effetti ipnotiċi.
Dependence Use of benzodiazepines and benzodiazepine-like agents may lead to physical and psychic dependence.
Dipendenza L- użu ta ’ benżodjażepin u ta ’ prodotti oħra simili għall- benżodjażepin jista ’ jwassal għal dipendenza fiżika u psikika.
The risk of dependence increases with dose and duration of treatment and is greater with patients having a history of alcohol and medicinal product abuse.
Ir- riskju ta ’ dipendenza jiżdied mad- doża u t- tul taż- żmien li jdum it- trattament.
Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms.
La darba d -
These may consist of 3 headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
3 dipendenza fiżika tiżvillupa, il- waqfien tat- trattament ħesrem jkun akkumpanjat minn sintomi ta ’ iżolament.
In severe cases the following symptoms may occur: unreality, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
F’ każi severi jistgħu jitfaċċjaw dawn is- sintomi: nuqqas ta ’ realtà, telfin tal- personalità, hyperacusis, nuqqas tas- sens tal- ħass u tingiż fit- tarf tas - swaba ’, sensittività qawwija għad- dawl, ħoss u kuntatt fiżiku, alluċinazzjonijiet jew attakki ta ’ epilessija.
There have been post-marketing reports of dependence associated with zaleplon, predominantly in combination with other psychotropic agents.
Kien hemm rapporti wara t- tqegħid fis- suq ta ’ dipendenza assoċjata ma ’ zaleplon, prinċipalment f’ kombinazzjoni ma mediċini psikotropiċi oħra.
Rebound insomnia and anxiety A transient syndrome whereby the symptoms that led to the treatment with a benzodiazepine or benzodiazepine-like agent recur in an enhanced form, may occur on withdrawal of treatment.
Problemi ta ’ rqad li jerġgħu jtitfaċċaw u anzjetà Sindromu temporanju, fejn is- sintomi li jwassal għat- trattament bil- benżodjażepin jew prodotti simili għall- benżodjażepin, li jerġa ’ jitfaċċa f’ forma aktar qawwija, jista ’ iseħħ meta titwaqqaf il- kura.
It may be accompanied by other reactions including mood changes, anxiety, or sleep disturbances and restlessness.
Dan jista ’ jkun akkumpanjat b’ reazzjonijiet oħra li jinkludu tibdil fil- burdati, anzjetà jew irqad imħarbat u nuqqas ta ’ sabar.
Duration of treatment The duration of treatment should be as short as possible (see section 4.2), and should not exceed two weeks.
Tul tat- trattament It- tul tat- trattament għandu jkun għall- iqsar żmien possibli (ara sezzjoni 4. 2), u m’ għandux jeċċedi ġimagħtejn.
Extension beyond these periods should not take place without clinical re-evaluation of the patient.
Estensjoni ta ’ dawn il- perjodi m’ għandhomx jingħataw mingħajr ma terga ’ issir evalwazzjoni klinika tal- pazjent.
It may be useful to inform the patient when treatment is started that it will be of limited duration.
Meta jinbeda it- trattament, tajjeb li l- pazjent ikun infurmat, li l- kura ser tingħata għal żmien limitat.
It is important that patients be aware of the possibility of rebound phenomena, thereby minimising anxiety should such symptoms develop when the medicinal product is discontinued.
Hu importanti li pazjenti jkunu konxji bil- possibilità li jerġgħu lura għalli kienu, biex b’ hekk titnaqqas l- anzjeta jekk is- sintomi jerġgħu jitfaċċaw meta il- prodott mediċinali jitwaqqaf.
Memory and psychomotor impairment Benzodiazepines and benzodiazepine-like agents may induce anterograde amnesia and psychomotor impairment.
Diżabilità fis- sistema tal- memorja tal- mekkaniżmu sikomatiku L- użu tal- benżodjażipin u prodotti simili għall- benżodjażipin, jista ’ jkunu kawża t’ amnesija li teffettaw il- memorja ta ’ qabel, u disabilità tal- mekkaniżmu sikomatiku.
These occur most often up to several hours after ingesting the product.
Dan jiġri ħafna drabi għal tul ta’ sigħat wara li wieħed jieħu l- prodott.
To reduce the risk, patients should not undertake activities requiring psychomotor co-ordination until 4 hours or more after taking Sonata (see section 4.7).
(ara sezzjoni 4. 7).
Psychiatric and “ paradoxical” reactions Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other behavioural effects are known to occur when using benzodiazepines or benzodiazepine-like agents.
Reazzjonijiet psikjatri u paradossali Reazzjonijiet bħal nuqqas ta ’ sabar, aġitazzjoni, burdati ħżiena, nuqqas t’ inibizzjoni, aggressività, ħsibijiet mhux normal, delużjonijiet, rabja, ħmir il- lejl, telfien ta ’ personalità, alluċinazzjonijiet, psikosi, imġiba mhux flokha, estrovertiżmu, u mġiba oħra li ma jaqblux mal- karattru tal- pazjent, ġew innutati li ġraw meta intuża benżodjażepin jew prodotti simili għall- benżodjażepin.
They may be active substance-induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder.
Dawn jistgħu ikunu ġejjin minħabba l- użu tal- mediċina, jew spontanji fl- oriġini tagħhom jew riżultat ta ’ disabilità moħbija li tkun ta ’ natura psikjatra jew fiżika.
These reactions are more likely to occur in the elderly.
Dawn ir- reazzjonijiet l- aktar li jseħħu fl- anzjani.
Should this occur, use of this product should be discontinued.
Jekk dan iseħħ, l- użu tal- prodott għandu jitwaqqaf.
Any new behavioural sign or symptom requires careful and immediate evaluation.
Xi sintomi ta ’ mġiba jew sinjali ġodda li jitfaċċaw, għandhom jkunu evalwati mill- ewwel u bil- għaqal.
Specific patient groups
Gruppi ta ’ pazjenti speċifiċi
Alcohol and medicinal product abuse Benzodiazepine and benzodiazepine-like agents should be used with extreme caution in patients with a history of alcohol or medicinal product abuse.
Abbuż mill- alkoħol u mid- droga L- użu tal- benżodjażepin u prodotti simili għall- benżodjażepin għandhom jintużaw b’ attenzjoni kbira f’ pazjenti li għandhom storja ta ’ alkoħol jew ta ’ abbuż mill- medicini.
Hepatic impairment Benzodiazepine and benzodiazepine-like agents are not indicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy (see section 4.2).
Insuffiċjenza tal- fwied L- użu tal- benżodjażepin u prodotti simili għall- benżodjażepin mhux maħsuba għat- trattament ta ’ pazjenti b’ insuffiċjenza severa epatika għax jistgħu jkunu kaġun għall- enkefalopatija (ara sezzjoni 4. 2).
In patients with mild to moderate hepatic insufficiency, the bioavailability of zaleplon is increased because of reduced clearance, and the dose will therefore need to be modified in these patients.
Id- doża għal dawn il- pazjenti għalhekk trid tiġi modifikata.
Renal impairment Sonata is not indicated to treat patients with severe renal impairment as it has not been adequately studied in those patients.
4 Insuffiċjenza renali Sonata mhux indikat għal dawk il- pazjenti b’ insuffiċjenza renali gravi peress li ma ġiex studjat sewwa fuq dawn il- pazjenti.
In patients with mild to moderate renal impairment, the pharmacokinetic profile of zaleplon is not significantly different than that in healthy subjects.
F’ pazjenti b’ insuffiċjenza renali ħafif jew moderat, il- profil farmakokinetiku ta ’ zaleplon kien simili għal pazjenti b’ saħħithom.
Hence, no dose adjustment is required in these patients.
Għalhekk, l- ebda aġġustament fid- doża ma hu neċessarju f’ pazjenti li għandhom insuffiċjenza renali bejn ħafif u moderat.
Respiratory insufficiency Caution should be observed when prescribing sedative medicinal products to patients with chronic respiratory insufficiency.
Insuffiċjenza respiratorja Wieħed għandu joqgħod attent meta jippreskribi prodotti sedattivi lill- pazjenti li għandhom insuffiċjenza respiratorja kronika.
4 Psychosis Benzodiazepine and benzodiazepine-like agents are not recommended for the primary treatment of psychotic illness.
Mard psikotiku L- użu tal- benżodjażepin u prodotti simili għall- benżodjażepin m’ humiex rakkomandati bħala trattament primarju għall- mard psikotiku.
Depression Benzodiazepines and benzodiazepine-like agents should not be used alone to treat depression or anxiety associated with depression (suicide may be precipitated in such patients).
Dipressjoni Benżodjażepin u prodotti simili għall- benżodjażepin m’ għandhomx jintużaw bħala trattament għad - dipressjoni jew anzjeta assoċjata mad- dipressjoni (f’ dawn il- pazjenti jista ’ jirriżulta s- suwiċidju).
Also, because of the increased risk for intentional overdose in patients with depression in general, the quantity of a medicinal product, including zaleplon, prescribed for such patients should be kept to the necessary minimum.
Barra dan, minħabba r- riskju li pazjenti b’ dipressjoni jistgħu jieħdu intenzjonalment doża eċċessiva, il - kwantita preskritta ta ’ prodotti mediċinali għal dawn il- pazjenti, inkluż zaleplon, għandha tinżamm fil - minimu neċessarju.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Concomitant intake with alcohol is not recommended.
Sonata ma għandhiex tittieħed ma l - alkoħol.
The sedative effect may be enhanced when the product is used in combination with alcohol.
L- effett seditivi jista ’ jkun li jiżdied meta il- prodott hu użat mal- alkoħol.
This affects the ability to drive or use machines (see section 4.7).
Dan jista ’ jaffettwa l- abilità li wieħed jsuq u li juża l- magni (ara sezzjoni 4. 3)
Combination with other CNS-acting compounds should be taken into account.
Meta jittieħed ma prodotti li jaħdmu fuq is- sistema ċentrali tan- nervituri (CNS- acting compounds) l - effetti oħra li jistgħu jirriżultaw għandhom jiġu ikkonsidrati.
Enhancement of the central sedation may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/ sedatives, antidepressant agents, narcotic analgesics, anti-epileptic medicinal products, anaesthetics, and sedative antihistamines.
Żjieda fis- sedazzjoni ċentrali tista ’ sseħħ f’ każijiet ta ’ l- użu assoċjat ma ’ prodotti kontra psikosi (nurolettiċi), ipnotiċi, anzjolitiċi/ sedattivi, prodotti kontra id- dipressjoni, analġesiċi narkotiċi, prodotti mediċinali kontra l- epilessija, anastetiċi, u prodotti kontra l- istamina li jraqqdu.
Coadministration of a single zaleplon 10 mg dose and venlafaxine (extended release) 75 mg or 150 mg daily did not produce any interaction on memory (immediate and delayed word recall) or psychomotor performance (digit symbol substitution test).
L- amministrazzjoni ta ’ doża unika ta ’ 10mg zaleplon u venlafaxin (mneħħi fuq tul ta ’ żmien estiż) 75 mg jew 150 mg kulljum ma jiproduċċux interazzjoni fuq il- memorja (immedjata jew ritardata fuq li wieħed jiftakar il- kliem) jew kif jaġixxi l- mekkaniżmu psikomatiku fl- individwu (f’ test ta ’ bdil bejn numri u simboli).
Additionally, there was no pharmacokinetic interaction between zaleplon and venlafaxine (extended release).
Barra dan, ma hemmx interazzjoni farmakokinetika bejn iż- zaleplon u venlafaxin (mneħħi fuq tul ta ’ żmien estiż).
In the case of narcotic analgesics enhancement of the euphoria may occur leading to an increase in physiological dependence.
Fil- każ ta ’ narkotici analġesiċi, jista ’ jkun hemm żjieda fl- ewforija u dan jista ’ iwasslu għal żjieda fid - dipendenza fiżjoloġika.
Cimetidine, a non-specific moderate inhibitor of several hepatic enzymes including both aldehyde oxidase and CYP3A4, produced an 85% increase in plasma concentrations of zaleplon because it inhibited both the primary (aldehyde oxidase) and secondary (CYP3A4) enzymes responsible for zaleplon’ s metabolism.
Iċ- ċimetidin, inibitur moderat mhux speċifikat ta ’ xi wħud mill- enżemi epatetiki aldeide ossidjat kif ukoll CYP3A4, ipproduċa żjieda 85% fil- konċentrazzjonijiet tal- plażma taż- zaleplon għaliex hi fixklet l- enżemi kemm enżimi primarji (aldeide ossidjat) kif ukoll sekondarji ta ’ (CYP3A4) li huma responabli għall- metaboliżmu zaleplon.
Therefore, caution is advisable in co-administering cimetidine and Sonata.
Għalhekk mhux rakkomandat l- użu taċ- ċimetidin u Sonata.
Co-administration of Sonata with a single 800 mg dose of erythromycin, a strong, selective CYP3A4 inhibitor, produced a 34% increase in zaleplon’ s plasma concentrations.
L- amministrazzjoni ta ’ Sonata ma ’ doża waħda 800 mg ta ’ erithromycin, li hu ta ’ tfixkil qawwi u selettiv ta ’ CYP3A4, ipproduċa żjieda ta ’ 34% fil- konċentrazzjonijiet tal- plażma ta ’ zaleplon.
A routine dosage adjustment of Sonata is not considered necessary, but patients should be advised that the sedative effects might be enhanced.
Aġġustament fir- rutina ta ’ Sonata mhix kunsidrata neċessarja, u l- pazjenti għandhom ikunu mgħarrfa li effetti sedattivi jistgħu jiżdiedu.
In contrast, rifampicin, a strong inducer of several hepatic enzymes, including CYP3A4 resulted in a four fold reduction in zaleplon plasma concentration.
B’ kuntrast, rifampicin, li hu stimulant qawwi għall- bosta enżimi epatiċi, inklużi CYP3A4 irriżulta tnaqqis t’ erba ’ darbiet fil- konċentrazzjoni tal- plażma ta’ zaleplon.
Co-administration of Sonata together with inducers of CYP3A4 such as rifampicin, carbamazepine and phenobarbitone, may result in a reduction of zaleplon’ s efficacy.
L- amministrazzjoni ta ’ Sonata flimkien ma prodotti li jistimulaw CYP3A4 bħal ma hu rifampicin, carbamazepine, u phenobarbitone, jistgħu jirriżultaw f’ nuqqas fl- effikaċja ta ’ zaleplon.
Sonata did not affect the pharmacokinetic and pharmacodynamic profiles of digoxin and warfarin, two compounds with a narrow therapeutic index.
5 Sonata ma teffettwax il- profili tal- farmakokinetika u tal- farmakodinamika ta ’ digoxin u ta ’ warfarin, żewġ komponenti li għandhom indiċi terapewtiċi dojoq.
In addition, ibuprofen, as an example of compounds that alter renal excretion, showed no interaction with Sonata.
Ma dan kollu, ibuprofen, bħala eżempju tal - komponenti li jbiddlu l- eleminazzjoni renali, urew li m’ għandhomx interazzjoni ma ’ Sonata.
Use of Sonata is not recommended during pregnancy.
Għalkemm fi studji fuq l- annimali ma dehrux effetti teratoġeniċi jew embrjotossiċi, m’ hemmx tagħrif kliniku biżżejjed fuq Sonata biex juri li hi jew mhix ta ’ ħsara matul it- tqala jew it- treddigħ.
If the medicinal product is prescribed to a woman of child-bearing potential, she should be warned to contact her physician regarding discontinuance of the medicinal product if she intends to become or suspects that she is pregnant.
Jekk il - prodott mediċinali jiġi preskritt lil mara li jista ’ jkollha t- tfal, hi għandha tkun imwissiha biex tgħid lit - tabib rigward it- twaqqif tal- prodott mediċinali, jekk ikollha l- ħsieb li toħroġ tqila jew tissuspetta li hi tqila.
If for compelling medical reasons, the medicinal product is administered during the late phase of pregnancy, or during labour at high doses, effects on the neonate, such as hypothermia, hypotonia and moderate respiratory depression, can be expected, due to the pharmacological action of the compound.
Jekk għar- raġunijiet assoluti neċessarji ta ’ mediċina, il- prodott mediċinali jkun amministrat matul l - aħħar fażi tat- tqala, jew matul il- ħlas f’ dożi għoljin, hu mistenni li jkun hemm effetti fuq it- tarbija, bħal ma huma l- ipotermja, l- ipotonja u d- depressjoni respiratorja moderata, minħabba l- azzjoni farmakoloġika tal- komponenti.
Infants born to mothers who took benzodiazepine and benzodiazepine-like agents chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period.
Trabi li jitwieldu minn ommijiet li ħadu il- benżodjażepin u prodotti simili għall- benżodjażepin regolarment matul l- aħħar waqtiet tat- tqala jistgħu jiżvillupaw dipendenza fiżika u jistgħu jkunu f’ risku li jiżvillupaw sintomi ta ’ iżolament fil- perjodu ta ’ wara t- twelid.
Because zaleplon is excreted in the breast milk, Sonata should not be administered to breast-feeding mothers.
Billi zaleplon joħroġ mal- ħalib tad- treddigħ, Sonata m’ għandhiex tiġi amministrata lill- ommijiet li jkunu qegħdin ireddgħu.
Sonata has major influence on the ability to drive and use machines.
Sonata iħalli effetti maġġuri fuq il- ħila ta ’ bniedem biex iħaddem magni u jsuq.