natgillin/translations-raw huggingface dataset:
Do not remove the syringe from the adapter at this point.
V tem trenutku še ne odpnite brizge z nastavka.
47 Figure 5
47 Slika 5
As explained for the first vial adapter, open now the second vial adapter by peeling back the protective cover.
Kot je pojasnjeno za prvi nastavek, zdaj odprite drugi nastavek za vialo, tako da odtrgate zaščitno prevleko.
Do not touch the vial adapter.
Ne dotikajte se nastavka za vialo.
Do not remove the adapter from the plastic packaging.
Ne jemljite nastavka iz plastične ovojnine.
While holding the plastic adapter packaging, place the adapter over the SOMAVERT vial and insert the piercing spike of the vial adapter all the way in through the rubber stopper of the SOMAVERT vial, using a pushing motion (Fig.
Držite plastično ovojnino nastavka, položite nastavek na vialo z zdravilom SOMAVERT in potisnite, tako da bo predorna konica nastavka povsem prebodla gumijasti zamašek viale z zdravilom SOMAVERT (Slika 5).
Disconnect the syringe from the solvent vial adapter and attach it to the vial adapter on the vial of SOMAVERT.
Odpnite brizgo z nastavka za vialo vehikla in jo namestite na nastavek na viali zdravila SOMAVERT.
Tilt the vial of SOMAVERT, adapter and syringe assembly to the side and gently inject the solvent down the inner side of the vial of SOMAVERT (Fig 6).
Nagnite vialo z zdravilom SOMAVERT, nastavek za vialo in nameščeno brizgo na eno stran in počasi vbrizgajte vehikel ob notranjosti stene viale z zdravilom SOMAVERT (slika 6).
Discard the solvent vial as directed by your healthcare provider.
Zavrzite vialo vehikla, kot vam je naročil zdravnik.
DO NOT SHAKE THE VIAL.
Držite vialo zdravila SOMAVERT, na kateri sta še vedno nameščena nastavek in brizga, pokonci med dlanmi in jo počasi valjajte med njimi, da se prašek raztopi (slika 7).
The solution should be clear after the powder is dissolved.
VIALE NE STRESAJTE.
If the solution is cloudy or hazy, do not inject it.
Ko se prašek raztopi, mora biti raztopina bistra.
Notify your pharmacy and request a replacement vial.
Če je motna ali megličasta, je ne injicirajte, ampak o tem povejte svojemu farmacevtu in prosite za nadomestno vialo.
Do not throw the vial away because the pharmacy may request that you return it.
Viale ne zavrzite, kajti v lekarni bodo morda želeli, da jo vrnete.
PREPARING THE INJECTION
PRIPRAVA ZA INJICIRANJE
Securely grasp the vial containing the SOMAVERT reconstituted solution, vial adapter and syringe assembly.
Trdno primite vialo, v kateri je pripravljena raztopina zdravila SOMAVERT, nastavek in nameščeno brizgo.
Carefully turn the vial, adapter and syringe assembly upside down.
Previdno obrnite vialo in nameščeno brizgo tako, da bo viala na vrhu.
Bring to eye level.
Dvignite v višino oči.
48 Figure 8
48 Slika 8
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.
Tako kot prej eno dlan previdno pomaknite navzdol ob viali, da boste lahko s palcem in kazalcem trdno prijeli vrat viale, s preostalimi prsti pa zgornji del brizge.
With the other hand, slowly pull the syringe plunger down to withdraw the full contents of the vial (1 ml).
Z drugo roko počasi potegnite bat navzdol, da boste izvlekli celotno vsebino viale (1 ml).
(Fig.8).
(Slika 8)
If bubbles are present, tap the syringe barrel until the bubbles rise to the top of the syringe.
Poglejte, ali so v brizgi zračni mehurčki.
Carefully push the plunger up to eject only the air bubbles back into the vial.
Če v raztopini so mehurčki, potrkajte po brizgi, da se dvignejo na njen vrh.
Recheck that 1 ml of the solution remains in the syringe.
Previdno potisnite bat navzgor, da boste nazaj v vialo iztisnili samo zračne mehurčke.
1 ml
Preverite, da je v brizgi ostal 1 ml raztopine.
Figure 9
1 ml Slika 9
Open the needle packaging so that only the end of the needle to be connected to the syringe is exposed.
Odprite ovojnino igle tako, da bo razgaljen le tisti del igle, ki ga je treba namestiti na brizgo.
The needle should be partially left in its protective packaging.
Iglo delno pustite v njeni zaščitni ovojnini.
Lay the needle with its protective packaging on the tabletop.
Iglo z zaščitno ovojnino položite na mizo.
Disconnect the syringe from the vial.
Odpnite brizgo z viale.
Discard the protective packaging and attach the needle to the syringe.
Odstranite zaščitno ovojnino in na brizgo namestite iglo.
Keep the plastic cap on the needle while preparing the site for injection (Fig.
Medtem ko pripravljate injekcijsko mesto, naj plastični pokrovček ostane na igli (slika 9).
Once reconstituted, SOMAVERT should be used immediately.
Ko je zdravilo SOMAVERT pripravljeno, ga morate uporabiti nemudoma.
GIVING THE INJECTION”.
Nadaljujte z 2. korakom “ Injiciranje ”.
b) NON VIAL ADAPTER METHOD
b) PRIPRAVA BREZ NASTAVKA ZA VIALO
Getting Started
PREDPRIPRAVA
• 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.
21, eno standardno 1- ml insulinsko brizgo, alkoholne ali antiseptične zložence in ustrezen vsebnik za porabljene igle. • Preverite datume izteka roka uporabnosti na nalepkah vial in brizg.
Preparing the SOMAVERT dose for injection
PRIPRAVA ODMERKA ZDRAVILA SOMAVERT ZA INJICIRANJE
Remove the protective plastic caps from the tops of both vials.
Odstranite plastična zaščitna pokrovčka z vrha obeh vial.
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.
Če se ju dotaknete ali ju kako drugače onesnažite, ju morate očistiti z alkoholnim ali antiseptičnim zložencem, preden skoznju zabodete iglo.
49 Carefully remove the cap from the needle of the larger syringe (3 ml) and set the cap aside.
49 Sli.
Pull the plunger of the solvent syringe down to the1 ml mark.
Potegnite bat brizge za vehikel navzdol do oznake 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.
Z eno roko trdno držite vialo z vehiklom, z drugo pa iglo brizge za vehikel zabodite naravnost skozi sredino gumijastega zamaška globoko v vialo.
(Fig.
Počasi potiskajte bat, dokler v vialo ne iztisnete vsega zraka (sli.
Securely grasp the solvent vial and syringe assembly, with the needle still deeply inserted into the vial.
Trdno primite vialo z vehiklom in nameščeno brizgo; igla je še vedno zabodena globoko v viali.
Carefully turn the vial and syringe assembly upside down.
Previdno obrnite vialo in nameščeno brizgo tako, da bo viala na vrhu.
Bring to eye level.
Dvignite ju v višino oči.
(Fig.
(Sli.
50 Examine the solution in the syringe for air bubbles.
Preglejte, ali so v raztopini, ki je v brizgi, zračni mehurčki.
Recheck that 1 ml of solvent remains in the syringe, then withdraw the needle from the vial.
Preverite, da je v brizgi ostal 1 ml vehikla, in iglo izvlecite iz viale.
(Fig 3)
(Sli.
Insert the needle of the solvent syringe straight through the stopper of the vial with the powder (SOMAVERT).
Zabodite iglo brizge z vehiklom naravnost skozi zamašek viale s praškom (SOMAVERT).
Tilt the syringe to the side and gently inject the solvent down the inner side of the vial of SOMAVERT.
Nagnite brizgo na eno stran in počasi vbrizgajte vehikel ob notranjosti stene viale z zdravilom SOMAVERT.
When the solvent syringe is empty, withdraw it from the vial.
Ko je brizga z vehiklom prazna, jo potegnite iz viale.
Discard the solvent vial, syringe, and needle as directed by your healthcare provider.
Zavrzite vialo vehikla, brizgo in iglo, kot vam je naročil zdravnik.
To minimise accidental injury, recap the needle only if instructed to do so by your healthcare provider, and in the manner demonstrated to you by your healthcare provider.
Pri ponovni namestitvi pokrovčka upoštevajte postopek, ki vam ga je pokazal zdravnik.
(Fig 4)
(Sli.
DO NOT SHAKE THE VIAL.
Držite vialo zdravila SOMAVERT pokonci med dlanmi in jo počasi valjajte med njimi, da se prašek raztopi.
Inject SOMAVERT immediately.
Zdravilo SOMAVERT injicirajte takoj.
Clean the rubber stopper of the vial of SOMAVERT with an antiseptic or alcohol swab.
Gumijasti zamašek viale z zdravilom SOMAVERT očistite z antiseptičnim ali alkoholnim zložencem.
Remove the cap from the syringe (1 ml).
Odstranite pokrovček z brizge (1 ml).
Pull the syringe plunger down to the 1-ml mark.
Potegnite bat brizge navzdol do oznake 1 ml.
With one hand, securely hold the vial.
Z eno roko trdno držite vialo.
With the other hand, insert the needle straight through the center of the rubber stopper and deep into the vial.
Z drugo roko zabodite iglo naravnost skozi sredino gumijastega zamaška globoko v vialo.
Securely grasp the vial and syringe assembly, with the needle still deeply inserted into the vial.
Trdno primite vialo z nameščeno brizgo; igla je še vedno zabodena globoko v viali.
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.
Morda boste morali iglo med izvlekom tekočine nekoliko potegniti ven, da bo konica igle ostala v tekočini.
Visually inspect the syringe for air bubbles.
Poglejte, ali so v brizgi zračni mehurčki.
Recheck that 1 ml of the solution remains in the syringe, then withdraw the needle from the vial.
Preverite, da je v brizgi ostal 1 ml raztopine, in iglo izvlecite iz viale.
Recap the needle as directed by your health care provider to minimise accidental injury while preparing the site for injection.
Da boste preprečili naključne vbode med pripravo injekcijskega mesta, na iglo namestite pokrovček, kot vam je naročil zdravnik.
STEP 2.
2.
GIVING THE INJECTION
INJICIRANJE
Choose an injection site on the upper arm, upper thigh, abdomen or buttocks.
Izberite injekcijsko mesto na nadlakti, stegnu, trebuhu ali zadnjici.
Always move on to a different area with each day’s injection.
Injekcijo dajte vsak dan na drugo mesto.
It may be helpful to keep a record of each day’s injection site as you take your daily dose of SOMAVERT.
Morda bo koristno, če si ob injiciranju dnevnega odmerka zdravila SOMAVERT vedno zabeležite, kam ste ga tisti dan injicirali.
Do not use an area that has a rash or broken skin, or is bruised or lumpy.
Ne injicirajte v predele z izpuščajem, poškodovano kožo, podplutbami ali bulami.
Clean the site with an antiseptic or alcohol swab, let the skin dry before injecting the product.
Mesto očistite z antiseptičnim ali alkoholnim zložencem in pustite, da se koža pred injiciranjem zdravila posuši.
Uncap the needle if previously recapped.
Snemite pokrovček z igle.
With one hand, gently pinch up the skin at the site of injection.
Kožo na injekcijskem mestu z eno roko rahlo stisnite v gubo.
Hold the syringe with the other hand, and in a single, smooth motion, push the needle completely into the skin straight down (at a 90-degree angle).
Z drugo roko držite brizgo in z enim samim naglim gibom zabodite iglo navpično (pod kotom 90 stopinj) do konca v kožo.
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.
Pazite, da ostane igla do konca zabodena v koži, medtem ko počasi potiskate bat navzdol, dokler brizga ni prazna.
Release the pinched skin and pull the needle straight out.
Izpustite stisnjeno kožo in iglo potegnite naravnost ven.
Do not rub the injection area.
Predela, v katerega ste injicirali, ne masirajte.
A small amount of bleeding may occur.
Pojavi se lahko drobna krvavitev.
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.
Če je treba, uporabite čist, suh kosem vate in na predel rahlo pritiskajte od 1 do 2 minuti oz. dokler se kri ne ustavi.
Disposing of Supplies
Odstranitev pribora
The syringe and needle should NEVER be reused.
Brizge in igle ne smete NIKOLI uporabiti znova.
Dispose of the needle and syringe as instructed by your doctor, nurse or pharmacist.
Iglo in brizgo zavrzite, kot vam je naročil zdravnik, medicinska sestra ali farmacevt.
Blister (PVC/ PVDC)
pretisni omot (PVC/ PVDC)
It is available as capsules (white and brown:
Na voljo je v obliki kapsul (bele in rjave:
5 mg; white:
5 mg; bele:
The recommended dose is 10 mg, except for the elderly or patients with mild or moderate liver disease, who should take 5 mg.
Priporočeni odmerek je 10 mg, razen pri starejših ali osebah z blagim ali zmernim obolenjem jeter, ki naj vzamejo 5- miligramski odmerek.
No food should be eaten with or shortly before taking Sonata, because it can reduce the medicine’ s effects.
Uživanje hrane hkrati z zdravilom Sonata ali tik pred tem ni priporočljivo, saj lahko zmanjša učinke zdravila.
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.
Je agonist receptorjev gama- aminomaslene kisline (GABA), kar pomeni, da se veže na receptorje za živčne prenašalce GABA in jih aktivira.
By activating its receptors, zaleplon increases GABA’ s effects, which encourages sleep.
Zaleplon z aktiviranjem receptorjev poveča učinke GABA, kar spodbuja spanec.
How has Sonata been studied?
Reproduction is authorised provided the source is acknowledged Kako je bilo zdravilo Sonata raziskano?
Sonata was compared with placebo (a dummy treatment) or with zolpidem or triazolam (other medicines used in insomnia).
Pet študij je bilo primerjalnih: zdravilo Sonata so primerjali s placebom (zdravilom brez zdravilne učinkovine) ali zolpidemom ali triazolamom (drugima zdraviloma za zdravljenje nespečnosti).
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.
V primerjavi s placebom je bil v dvotedenskih študijah pri starejših bolnikih, ki so jemali zdravilo Sonata v odmerku 5 mg, čas, potreben, da so zaspali, pogosto krajši, pri jemanju 10- miligramskih odmerkov pa je bil vedno krajši.
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.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Sonata pri zdravljenju hude nespečnosti, ki težko zaspijo, kadar je motnja huda, ki osebo onesposobi ali ji povzroča izjemno neugodje, večje od z njim povezanih tveganj.
Lactose monohydrate 54 mg.
54 mg laktoze monohidrata
Capsules have an opaque white and opaque light brown hard shell with gold band, “ W” and the strength “ 5 mg”.
Kapsule imajo neprozorno belo in neprozorno svetlo rjavo trdo ovojnico z zlato črto, » W « in jakostjo » 5 mg «.
Elderly Elderly patients may be sensitive to the effects of hypnotics; therefore, 5 mg is the recommended dose of Sonata.
Starejši bolniki Starejši bolniki so lahko občutljivi za učinke uspaval, zato je zanje priporočeni odmerek zdravila Sonata 5 mg.
Paediatric patients Sonata is contraindicated in children (see section 4.3).
Otroci Uporaba zdravila Sonata je kontraindicirana pri otrocih (glejte poglavje 4. 3).
Hepatic impairment As clearance is reduced, patients with mild to moderate hepatic impairment should be treated with Sonata 5 mg.
Jetrna okvara Ker je očistek zdravila zmanjšan, morate bolnike z blago do zmerno jetrno okvaro zdraviti z zdravilom Sonata 5 mg.
For severe hepatic impairment see section 4.3.
Za hudo jetrno okvaro glejte poglavje 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.
2 Ledvična okvara Pri bolnikih z blago do zmerno ledvično insuficienco ni potrebna prilagoditev odmerka, ker farmakokinetika zdravila Sonata pri teh bolnikih ni spremenjena.
Severe renal impairment is contraindicated (see section 4.3.).
Pri hudi ledvični okvari je kontraindicirano (glejte poglavje 4. 3.).
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)
Preobčutljivost za zdravilno učinkovino ali katero izmed pomožnih snovi Huda jetrna okvara Huda ledvična okvara Sindrom apneje v spanju Miastenija gravis Hude težave z dihanjem Otroci (mlajši od 18 let)
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.
Pri bolnikih, ki jemljejo sedative/ hipnotike, poročajo o oblikah kompleksnega vedenja, kakršna je “ vožnja v polsnu ” (tj., upravljanje motornega vozila v ne povsem budnem stanju po zaužitju sedativa/ hipnotika in s poznejšo amnezijo za ta dogodek).
These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic experienced persons.
Ti dogodki se lahko pojavijo tako pri bolnikih, ki sedativa/ hipnotika prej še nikoli niso vzeli, kot tudi pri tistih, ki ga že jemljejo.
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.
Čeprav se takšne oblike vedenja, kot je vožnja v polsnu, lahko pojavijo, če bolnik vzame samo sedativ/ hipnotik v terapevtskih odmerkih, se zdi, da uživanje alkohola in drugih depresorjev centralnega živčnega sistema (CŽS) skupaj s sedativi/ hipnotiki zveča nevarnost takšnih oblik vedenja, isto pa velja za prekoračitev največjega priporočenega odmerka zdravila.
Due to the risk to the patient and the community, discontinuation of zaleplon is recommended for patients who report a “ sleep-driving” episode.
Zaradi tveganja za bolnika in okolico je pri bolnikih, ki poročajo o epizodi » vožnje v polsnu «, priporočljivo zaleplon ukiniti.
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.
Pri bolnikih, ki po tistem, ko vzamejo sedativ/ hipnotik, niso povsem budni, so poročali še o drugih vrstah kompleksnega vedenja (npr. priprava in uživanje hrane, telefoniranje ali spolno občevanje).
Severe anaphylactic/ anaphylactoid reactions have been reported with the use of sedative-hypnotics, including zaleplon.
Pri jemanju sedativov/ hipnotikov, vključno z zaleplonom, so poročali o hudih anafilaktičnih/ anafilaktoidnih reakcijah.
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.
Po zaužitju prvega ali kakšnega poznejšega odmerka sedativov/ hipnotikov, vključno z zaleplonom, so poročali o primerih angioedema jezika, glotisa ali larinksa.
Some patients taking sedative-hypnotics have had additional symptoms such as dyspnoea, throat closing, or nausea and vomiting.
Nekateri bolniki, ki so jemali sedative/ hipnotike, so imeli še dodatne simptome, na primer dispneo, zaporo žrela ali navzeo in bruhanje.
Due to zaleplon’ s short plasma half-life, alternative therapy should be considered if early morning awakening is experienced.
Zaradi kratke razpolovne dobe zaleplona morate premisliti o uporabi drugega načina zdravljenja v primeru zgodnjega jutranjega zbujanja bolnika.
(See section 4.5)
Sočasno odmerjanje zdravila Sonata z zdravili, ki vplivajo na izoencim CYP3A4, lahko povzroči spremembe koncentracije zaleplona v plazmi (glejte poglavje 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.
Toleranca Po nekajtedenski zaporedni uporabi lahko nastopi zmanjšanje uspavalnega učinka kratkotrajno delujočih benzodiazepinov in njim sorodnih učinkovin.
Dependence Use of benzodiazepines and benzodiazepine-like agents may lead to physical and psychic dependence.
Odvisnost Uporaba benzodiazepinov in njim sorodnih učinkovin, lahko privede do telesne in duševne odvisnosti.
Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms.
Tveganje za pojav odvisnosti se povečuje z odmerkom in trajanjem zdravljenja in je večje pri bolnikih, ki
These may consist of 3 headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
Ko se pojavi telesna odvisnost, nenadno prekinitev zdravljenja spremljajo odtegnitveni sindromi.
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.
Povrnitev nespečnosti in tesnoba Prehodni sindrom, pri katerem se simptomi, ki so privedli do zdravljenja z benzodiazepinom ali njemu podobnim zdravilom, pojavijo v okrepljeni obliki po prenehanju zdravljenja.
Duration of treatment The duration of treatment should be as short as possible (see section 4.2), and should not exceed two weeks.
Trajanje zdravljenja Zdravljenje mora biti čim krajše (glejte poglavje 4. 2), ne več od dveh tednov.
Memory and psychomotor impairment Benzodiazepines and benzodiazepine-like agents may induce anterograde amnesia and psychomotor impairment.
Spomin in psihomotorične motnje Benzodiazepini in njim podobne snovi, lahko sprožijo anterogradno amnezijo in psihomotorične motnje.
These occur most often up to several hours after ingesting the product.
Le - te se največkrat pojavijo več ur po zaužitju zdravila.
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).
Za zmanjšanje tveganja bolniki ne bi smeli opravljati aktivnosti, ki zahtevajo psihomotorično koordinacijo do 4 ure ali več po zaužitju zdravila Sonata (glej poglavje 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.
Psihiatrične in » paradoksne « reakcije Reakcije kot so nemir, razburjenje, razdražljivost, popustitev zavor, agresivnost, nenormalno mišljenje, zabloda, bes, nočne more, depersonalizacija, halucinacije, psihoze, neprimerno vedenje, ekstrovertiranost, ki se zdi pretirana, ter drugi vedenjski učinki se lahko pojavijo ob uporabi benzodiazepinov ali njim sorodnih učinkovin.
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.
Zloraba alkohola in zdravila Benzodiazepine in njim podobne snovi, morate uporabljati zelo previdno pri bolnikih, ki imajo v anamnezi zlorabo alkohola ali zdravila.
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).
Jetrna okvara Benzodiazepini in njim podobne snovi, niso indicirani za zdravljenje bolnikov s hudo jetrno insuficienco, saj lahko povzročijo encefalopatijo (glejte poglavje 4. 2).
Renal impairment Sonata is not indicated to treat patients with severe renal impairment as it has not been adequately studied in those patients.
Ledvična okvara Zdravilo Sonata ni indicirano za zdravljenje bolnikov s hudo ledvično okvaro, ker pri takih bolnikih niso bile opravljene ustrezne študije.