FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the inflexibility with regard to dose increases and to the increased dose requirements during pregnancy, Sixmo is not considered to be an optimal treatment choice for pregnant women, therefore treatment with Sixmo should not be started in pregnant women.
Slovenian: Zaradi neprilagodljivosti v zvezi s povečevanjem odmerka in zaradi potreb po večjem odmerku med nosečnostjo, zdravilo Sixmo ne velja za optimalno izbiro zdravljenja pri nosečnicah, zato zdravljenja z zdravilom Sixmo ni dovoljeno uvesti pri nosečnicah.
English: Clinical studies of Sixmo did not include patients over 65 years and, therefore, the use of the product in this population is not recommended.
Slovenian: Klinične študije zdravila Sixmo niso vključevale bolnikov, starejših od 65 let, zato uporaba tega zdravila pri tej populaciji ni priporočljiva.
English: The safety and efficacy of Sixmo was investigated in 3 double-blind Phase 3 clinical studies in which a total of 309 patients were treated with Sixmo for up to 6 months (1 implant cycle).
Slovenian: Klinična učinkovitost in varnost zdravila Sixmo Varnost in učinkovitost zdravila Sixmo so preučevali v 3 dvojno slepih kliničnih študijah 3. faze, kjer so skupno 309 bolnikov z zdravilom Sixmo zdravili do 6 mesecev (1 cikel implantatov).
English: Before inserting Sixmo, your doctor will give you a local anaesthetic to numb the area.
Slovenian: Preden bo zdravnik vstavil zdravilo Sixmo, vam bo dal lokalni anestetik, da bo omrtvičil območje.
English: There is no suspicion of carcinogenicity based on the clinical use of buprenorphine.
Slovenian: Sum na kancerogenost na podlagi klinične uporabe buprenorfina ne obstaja.
English: Buprenorphine may reduce the ability to drive and use machines; especially during the first 24 to 48 hours up to one week following implant insertion.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Buprenorfin lahko poslabša sposobnost upravljanja vozil in strojev, zlasti v prvih 24 do 48 urah ter do enega tedna po vstavitvi implantata.
English: Patients may experience somnolence, especially in the first week following insertion of the implants and should be cautioned in this respect (see section 4.7).
Slovenian: Pri bolnikih se lahko pojavi zaspanost, zlasti prvi teden po vstavitvi implantatov, na kar je bolnike treba opozoriti (glejte poglavje 4.7).
English: Excessive palpation shortly after insertion of the implants may increase the chance of infection.
Slovenian: Prekomerna palpacija takoj po vstavitvi implantatov lahko poveča možnost za okužbo.
English: Especially, inform your doctor during Sixmo treatment before using:
Slovenian: Zlasti obvestite zdravnika med uporabo zdravila Sixmo, preden vzamete:
English: MOLTeNI-2019-01 - A prospective, observational (non-interventional), postauthorisation safety cohort study to evaluate the incidence of the breakages and insertion/removal complications of buprenorphine implants (Sixmo) in the routine clinical care
Slovenian: MOLTeNI-2019-01 - Prospektivna, opazovalna (neintervencijska) kohortna študija v obdobju trženja za ocenitev incidence zloma in zapletov z vstavitvijo/odstranitvijo implantatov buprenorfina (Sixmo) v rutinski klinični negi
English: The formation of norbuprenorphine was initially found to be performed by CYP3A4; subsequent studies also demonstrated the involvement of CYP2C8.
Slovenian: Najprej je bilo ugotovljeno, da norbuprenorfin nastaja prek citokroma CYP3A4, nadaljnje študije pa so pokazale tudi vpletenost citokroma CYP2C8.
English: • have acute alcoholism or alcohol delirium caused by withdrawal from alcohol
Slovenian: • če imate akutni alkoholizem ali alkoholni delirij zaradi odtegnitve od alkohola;
English: Study PRO-806 included an open-label comparator arm with sublingual buprenorphine (12 to 16 mg/day).
Slovenian: Študija PRO-806 je vključevala odprti primerjalni krak s podjezičnim buprenorfinom (12 do 16 mg/dan).
English: The efficacy and safety of buprenorphine in elderly patients > 65 years has not been established.
Slovenian: Učinkovitost in varnost buprenorfina pri bolnikih, starejših od 65 let, nista bili dokazani.
English: Buprenorphine and its metabolites are excreted in human milk to such an extent that effects on the breastfed newborns/infants are likely.
Slovenian: Buprenorfin in njegovipresnovki se v materino mleko izločajo v tolikšnem obsegu, da je možen učinek na dojene novorojence/otroke.
English: • depression, euphoria
Slovenian: • depresija, evforija,
English: Implants should be removed under aseptic conditions, whereby the following equipment is needed:
Slovenian: Implantate je treba odstraniti v aseptičnih pogojih, potrebna pa je naslednja oprema:
English: A mass balance study of buprenorphine showed complete recovery of radiolabel in urine (30%) and faeces (69%) collected up to 11 days after dosing.
Slovenian: Izločanje Študija masnega ravnovesja buprenorfina je pokazala popolno izločenje radioaktivno označene spojine z urinom (30 %) in blatom (69 %), katerih vzorci so bili odvzeti do 11. dni po odmerjanju.
English: Because buprenorphine levels cannot be adjusted during Sixmo treatment, Sixmo is contraindicated in patients with severe hepatic impairment (Child-Pugh C) (sections 4.3, 4.4 and 5.2).
Slovenian: Ker ravni buprenorfina med zdravljenjem z zdravilom Sixmo ni mogoče prilagoditi, je zdravilo Sixmo kontrainidicirano pri bolnikih s hudo okvaro jeter (Child-Pugh C) (poglavja 4.3, 4.4 in 5.2).
English: Deaths have also been reported in association with concomitant administration of buprenorphine and other depressants such as alcohol or other opioids.
Slovenian: O smrtnih primerih so poročali tudi v povezavi s sočasno uporabo buprenorfina in drugih depresorjev, kot sta alkohol ali drugi opioidi.
English: Pups exposed to buprenorphine only during the prenatal period had a similar body weight compared with controls in the first 3 postnatal weeks.
Slovenian: Mladiči, ki so bili buprenorfinu izpostavljeni le v prenatalnem obdobju, so imeli v prvih 3 ponatalnih tednih telesno maso podobno kontrolni skupini.
English: Step 2: Clean the insertion site with an alcohol pad.
Slovenian: 2. korak: Mesto vstavitve očistite z alkoholno blazinico.
English: • Opioid antagonists: naltrexone and nalmefene can block the pharmacological effects of buprenorphine.
Slovenian: • opioidnimi antagonisti: naltrekson in nalmefen lahko blokirata farmakološke učinke buprenorfina.
English: • 5 mL syringe with 25G×1.5" needle (0.5×38 mm)
Slovenian: • 5-ml brizga z iglo velikosti 25 G × 1,5 palca (0,5 × 38 mm),
English: After Sixmo implant insertion, an initial buprenorphine peak was observed and the median Tmax occurred at 12 hours after insertion.
Slovenian: Po vstavitvi implantata Sixmo je bil opažen začetni višek buprenorfina, z medianim Tmax 12 ur po vstavitvi.
English: • reopening of a closed wound
Slovenian: • vnovično odprtje zaprte rane,
English: The demonstration of efficacy relies primarily on study PRO-814, a randomized, double-blind and active-controlled Phase 3 study in adult patients who met DSM-IV-TR criteria for opioid dependence and who were clinically stabilised on sublingual buprenorphine.
Slovenian: Prikaz učinkovitosti temelji predvsem na študiji PRO-814, randomizirani, dvojno slepi in z aktivno kontrolo nadzorovani študiji 3. faze pri odraslih bolnikih, ki so izpolnjevali pogoje DSM-IV-TR glede odvisnosti od opioidov in so bili klinično stabilizirani s podjezičnim buprenorfinom.
English: • verapamil, diltiazem, amiodarone: medicines to treat high blood pressure and heart disorders
Slovenian: • verapamil, diltiazem, amiodaron: zdravila za zdravljenje visokega krvnega tlaka in srčnih bolezni;
English: Plasma concentrations of buprenorphine after insertion of Sixmo are highest during the first 24 to 48 hours.
Slovenian: Koncentracije buprenorfina v plazmi so po vstavitvi zdravila Sixmo najvišje v prvih 24 do 48 urah.
English: There are no prospective data with Sixmo beyond two treatment cycles, and there is no experience with inserting Sixmo implants into other sites of the arm, sites other than the upper arm or re-insertion into previously-used sites.
Slovenian: Ni prospektivnih podatkov o več kot dveh ciklih zdravljenja z zdravilom Sixmo, prav tako ni izkušenj z vstavljanjem implantatov Sixmo v druge dele roke (razen nadlakti) oziroma izkušenj s ponovno vstavitvijo v prej uporabljena mesta.
English: Improper removal carries risk of implant-site infection and implant breakage.
Slovenian: Neustrezno odstranjevanje prinaša tveganje za okužbo na mestu implantata in zlom implantata.
English: A number of cases of death due to respiratory depression have been reported while on buprenorphine, particularly when buprenorphine was used in combination with benzodiazepines (see section 4.5) or when buprenorphine was not used according to prescribing information.
Slovenian: Poročali so o številnih primerih s smrtnim izidom zaradi depresije dihanja med uporabo buprenorfina, zlasti pri uporabi buprenorfina skupaj z benzodiazepini (glejte poglavje 4.5) ali kadar se buprenorfin ni uporabljal v skladu z navodili glede predpisovanja.
English: • the patient experiences lack of efficacy, as evidenced by lasting withdrawal symptoms that require repeated management with sublingual buprenorphine
Slovenian: • v primeru premajhne učinkovitosti pri bolniku, na kar nakazujejo dolgotrajni odtegnitveni simptomi, ki zahtevajo ponavljajoče zdravljenje s podjezičnim buprenorfinom.
English: Step 17: After removal of all implants, clean the incision site.
Slovenian: 17. korak: Ko odstranite vse implantate, očistite mesto reza.
English: • Patients who have contraindications for MRI should be not allowed to receive the implant.
Slovenian: • Bolniki s kontraindikacijami za MRI ne smejo prejeti implantata.
English: If opioid therapy is required as part of anaesthesia, patients should be continuously monitored in an anaesthesia care setting by persons not involved in the conduct of the surgical or diagnostic procedure.
Slovenian: Če je v sklopu anestezije potrebna terapija z opioidi, morajo bolnike v anestezijskem okolju stalno spremljati osebe, ki niso vključene v izvajanje kirurškega ali diagnostičnega postopka.
English: Do not drink alcohol during Sixmo treatment, as it increases the sedative effect.
Slovenian: Med uporabo zdravila Sixmo ne pijte alkohola, ker povečuje učinek sedacije.
English: Buprenorphine can cause fatal breathing problems in non-dependent people or children.
Slovenian: Buprenorfin lahko povzroči usodne težave z dihanjem osebah, ki niso odvisne, ali pri otrocih.
English: These adverse reactions are presented by MedDRA system organ class, preferred term, and frequency.
Slovenian: Ti neželeni učinki so razvrščeni po organskih sistemih MedDRA, po prednostnem izrazu in pogostnosti.
English: See “Driving and using machines”.
Slovenian: Glejte „Vpliv na sposobnost upravljanja vozil in strojev“.
English: The partial opioid agonist properties of buprenorphine may precipitate opioid withdrawal signs and symptoms in persons who are currently physically dependent on full opioid agonists - such as heroin, morphine, or methadone - before the effects of the full opioid agonist have subsided.
Slovenian: Buprenorfin zaradi svojih značilnosti delnega opioidnega agonista lahko povzroči odtegnitvene znake in simptome pri osebah, ki so trenutno fizično odvisne od polnih opioidnih agonistov, kot so heroin, morfin in metadon, še preden učinki polnega opioidnega agonista prenehajo.
English: • infection, such as viral infection (e.g. flu)
Slovenian: • okužba, kot je virusna okužba (npr. gripa),
English: Pharmacotherapeutic group: Other nervous system drugs, Drugs used in opioid dependence, ATC code: N07BC01
Slovenian: 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: druga zdravila z delovanjem na živčevje, zdravila za zdravljenje odvisnosti z opioidi, oznaka ATC: N07BC01
English: In both studies adult patients with opioid dependence who were new entrants to buprenorphine treatment were treated over 24 weeks with 4 Sixmo or 4 placebo implants.
Slovenian: V obeh študijah so bili odrasli bolniki z odvisnostjo od opioidov, ki so bili na novo deležni zdravljenja z buprenorfinom, zdravljeni 24 tednov s 4 implantati zdravila Sixmo ali 4 implantati s placebom.
English: Uncommon, may affect up to 1 in 100 people
Slovenian: Občasni, pojavijo se lahko pri največ 1 od 100 bolnikov
English: Generally, concentrations were comparable to the trough buprenorphine concentration of 8 mg per day sublingual buprenorphine.
Slovenian: Na splošno so bile koncentracije primerljive z najnižjo koncentracijo buprenorfina, doseženo pri odmerku 8 mg na dan v obliki podjezičnega buprenorfina.
English: Generally, other buprenorphine treatments/formulations are considered more appropriate in this situation.
Slovenian: V tem primeru so na splošno ustreznejša druga zdravila/pripravki, ki vsebujejo buprenorfin.
English: • two X-plant clamps (vasectomy fixation clamps with 2.5 mm ring diameter)
Slovenian: • dve sponki X-plant (fiksacijske sponke za vazektomijo s premerom odprtine 2,5 mm),
English: Sixmo should be used only in patients who are opioid tolerant.
Slovenian: Zdravilo Sixmo smejo uporabljati le bolniki, ki nimajo intolerance na opioide.
English: Each Sixmo implant is packaged individually into a PET/LDPE/Alu/LDPE-peelable foil laminate sachet.
Slovenian: Vsak implantat zdravila Sixmo je pakiran posamično v laminirane vrečice iz folije PET/LDPE/Alu/LDPE.
English: Prior to initiating Sixmo therapy, the patient's medical and treatment history, including use of nonopioid psychoactive substances, needs to be reviewed, in order to ensure that Sixmo treatment can be safely initiated.
Slovenian: Pred uvedbo zdravljenja z zdravilom Sixmo je treba pregledati bolnikovo zgodovino zdravljenja, vključno z uporabo neopioidnih psihoaktivnih snovi, da zagotovite varno uvedbo zdravljenja z zdravilom Sixmo.
English: Table 1: Adverse reactions reported in clinical studies and from post-marketing data with Sixmo and/or reported with other buprenorphine product System organ class
Slovenian: Preglednica 1: Neželeni učinki, o katerih so poročali v kliničnih študijah in po začetku trženja zdravila Sixmo in/ali o katerih so poročali v povezavi z drugimi zdravili, ki vsebujejo buprenorfin Organski sistem
English: Do not force the implant beyond the end of the cannula with the obturator.
Slovenian: Implantata z mandrenom ne potiskajte preko konca kanile.
English: In faeces, almost all of the buprenorphine and norbuprenorphine were free (buprenorphine: 33% free and 5% conjugated; norbuprenorphine: 21% free and 2% conjugated).
Slovenian: V blatu sta bila skoraj ves buprenorfin in norbuprenorfi prosta (buprenorfin: 33 % prostega in 5 % konjugiranega; norbuprenorfin: 21 % prostega in 2 % konjugiranega).
English: Sublingual buprenorphine N=119
Slovenian: Podjezični buprenorfin n = 119
English: There should be at least 5 mm between the incision and the implant when the implant is properly positioned.
Slovenian: Med rezom in implantatom mora biti vsaj 5 mm prostora, če je implantat ustrezno nameščen.
English: The safety and efficacy of Sixmo in children under 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Sixmo pri otrocih, starih manj kot 18 let, nista bili dokazani.
English: Do not use these medicines during Sixmo treatment as they can cause a sudden onset of prolonged, intense withdrawal symptoms.
Slovenian: Teh zdarvil med zdravljenjem z zdravilom Sixmo ne uporabljajte, saj lahko nenadoma sprožijo dolgotrajne, intenzivne odtegnitvene simptome;
English: They are removed by the doctor at the end of the sixth month.
Slovenian: Na koncu obdobja 6 mesecev jih zdravnik odstrani.
English: Alternatively, replacement implant(s) may be inserted in the contralateral arm.
Slovenian: Nadomestni(-e) implantat(-e) lahko vstavite tudi v nasprotno roko.
English: • vulvovaginal fungal infection
Slovenian: • vulvovaginalna glivična okužba,
English: • aprepitant: a medicine to prevent nausea and vomiting
Slovenian: • aprepitant: zdravilo za preprečevanje slabosti in bruhanja;
English: The opioid antagonist naloxone is a specific antidote to respiratory depression resulting from opioid overdose.
Slovenian: Opioidni antagonist nalokson je specifični antidot za depresijo dihanja, ki se pojavi zaradi prevelikega odmerjanja opioidov.
English: Higher than normal doses and repeated administration may be necessary.
Slovenian: Morda bodo potrebni večji odmerki kot običajno in večkratno dajanje.
English: • local anaesthetic, such as 1% lidocaine with adrenaline 1:100,000
Slovenian: • lokalni anestetik, kot je 1-% lidokain z adrenalinom 1 : 100.000,
English: Mark the insertion site with the surgical marker.
Slovenian: Mesto vstavitve označite s kirurškim markerjem.
English: In the case of non-palpable implants, removal should be performed under ultrasound guidance (following their localisation).
Slovenian: Če implantatov ni mogoče zatipati, je treba postopek odstranjevanja izvesti pod ultrazvočnim vodenjem (po njihovi lokalizaciji).
English: Due to the long half-life of buprenorphine, neonatal monitoring for several days should be considered at the end of pregnancy, to prevent the risk of respiratory depression or withdrawal syndrome in neonates.
Slovenian: Zaradi dolge razpolovne dobe buprenorfina je treba razmisliti o nekajdnevnem neonatalnem spremljanju ob koncu nosečnosti, da se prepreči tveganje za depresijo dihanja ali odtegnitveni sindrom pri novorojencih.
English: L. Molteni & C. dei Fratelli Alitti Societa di Esercizio S.p.A. Strada Statale 67
Slovenian: L. Molteni & C. dei Fratelli Alitti Societa di Esercizio S.p.A.
English: The most frequent non-implant adverse reactions in clinical studies with Sixmo were headache, constipation and insomnia.
Slovenian: Najpogostejši neželeni učinki, nepovezani z implantatom, v kliničnih študijah z zdravilom Sixmo so bili glavobol, zaprtost in nespečnost.
English: At steady state, a small decrease in buprenorphine concentrations was also recorded between week 4 and week 24.
Slovenian: V stanju dinamičnega ravnovesja je bilo manjše zmanjšanje koncentracije buprenorfina opaženo tudi med 4. in 24. tednom.
English: Patients requiring opioid therapy for analgesia may be treated with a high-affinity full opioid analgesic under the supervision of a healthcare professional, with particular attention to respiratory function.
Slovenian: Bolnike, pri katerih je za analgezijo potrebna terapija z opioidi, je dovoljeno zdraviti z visokoafinitetnimi polno opioidnimi analgetiki pod nadzorom zdravstvenega strokovnjaka, ki mora biti pozoren zlasti na respiratorno funkcijo.
English: Step 16: After removal of each implant, confirm that the entire 26.5 mm long implant has been removed by measuring its length.
Slovenian: 16. korak: Ko odstranite vsak implantat, potrdite, da ste odstranili celoten 26,5-milimetrski implantat tako, da pomerite njegovo dolžino.
English: Note: Do not push the obturator.
Slovenian: Opomba: Mandrena ne potiskajte.
English: • small bleeds beneath the skin
Slovenian: • manjše krvavitve pod kožo,
English: Bring it to the inserting doctor to determine whether the full implant has been expelled.
Slovenian: Prinesite ga zdravniku, ki je opravil vstavitev, da oceni, ali se je iztisnil celoten implantat.
English: • The healthcare professional must carefully monitor the patient until the implant is replaced to evaluate for withdrawal or other clinical indicators suggesting that supplemental sublingual buprenorphine may be needed.
Slovenian: • Zdravstveni strokovnjak mora bolnika skrbno spremljati, dokler bolnik ne dobi drugega implantata, in ocenjevati odtegnitvene simptome ali druge klinične kazalnike, ki bi kazali na to, da bo treba uporabiti dodatni podjezični buprenorfin.
English: Using aseptic technique, place the sterile equipment on the sterile field of the instrument stand.
Slovenian: Z aseptično tehniko sterilno opremo postavite v sterilno polje na instrumentarsko mizico.
English: If you stop Sixmo treatment your doctor will monitor you for withdrawal symptoms.
Slovenian: Če zdravljenje z zdravilom Sixmo prekinete, vas bo zdravnik spremljal glede odtegnitvenih simptomov.
English: Renal elimination plays a relatively small role (approximately 30%) in the overall clearance of buprenorphine and buprenorphine plasma concentrations were not increased in patients with renal impairment.
Slovenian: Okvara ledvic Izločanje skozi ledvice igra relativno majhno vlogo (približno 30 %) pri celokupnem očistku buprenorfina, koncentracije buprenorfina v plazmi pa se pri bolnikih z okvaro ledvic niso povečale.
English: Although some patients may require occasional supplemental dosing with buprenorphine, patients should not be provided with prescriptions for sublingual buprenorphine-containing products for asneeded use.
Slovenian: Čeprav bodo nekateri bolniki občasno morda potrebovali dodatne odmerke buprenorfina, bolniki ne smejo prejeti receptov za podjezična zdravila, ki vsebujejo buprenorfin, za uporabo po potrebi.
English: If you have more Sixmo than you need
Slovenian: Če ste dobili večji odmerek zdravila Sixmo, kot bi smeli
English: Exploratory surgery without knowledge of the exact location of all implants is strongly discouraged.
Slovenian: Kirurški poseg brez predhodne natančne določitve lokacije vseh implantatov močno odsvetujemo.
English: PHARMACEUTICAL FORM AND CONTENTS 4 implants
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 4 implantati
English: Apply the sterile fenestrated drape to the patient's arm (Figure 4).
Slovenian: Na bolnikovo roko namestite sterilno fenestrirano prevleko (slika 4).
English: • The insertion and removal of Sixmo should take place under aseptic conditions.
Slovenian: • Zdravilo Sixmo je treba vstavljati in odstranjevati v aseptičnih pogojih.
English: • One applicator is used to insert all four implants.
Slovenian: • En aplikator se uporabi za vstavitev vseh štirih implantatov.
English: Verify that patients have completed an appropriate induction period with sublingual buprenorphine or buprenorphine/naloxone, or are already clinically stable on buprenorphine or buprenorphine/naloxone before inserting Sixmo implants (see section 4.2).
Slovenian: Preverite, ali so bolniki zaključili ustrezno uvajalno obdobje s podjezičnim buprenorfinom ali buprenorfinom/naloksonom oziroma ali so že klinično stabilni na buprenorfinu ali buprenorfinu/naloksonu, preden vstavite implantate Sixmo (glejte poglavje 4.2).
English: Buprenorphine may cause drowsiness, particularly when taken together with alcohol or CNS depressants (such as tranquilisers, sedatives or hypnotics) (see section 4.5).
Slovenian: Buprenorfin lahko povzroča dremavost, zlasti kadar se uporablja skupaj z alkoholom ali depresorji centralnega živčnega sistema (kot so pomirjevala, sedativi ali hipnotiki) (glejte poglavje 4.5).
English: Buprenorphine undergoes N-dealkylation to its major pharmacologically active metabolite norbuprenorphine and subsequent glucuronidation.
Slovenian: Buprenorfin se N-dealkilira v svoj glavni farmakološko aktivni presnovek norbuprenorfin in se zatem glukuronidira.
English: Use the sterile gauze and apply gentle pressure to the incision site, for five minutes, to ensure haemostasis.
Slovenian: Uporabite sterilno gazo in pet minut nežno pritiskajte na mesto reza, da zagotovite hemostazo.
English: • surgical marker
Slovenian: • kirurški marker,
English: • in case of patient's self-reported heroin use, other opioid use or craving and/ or urine samples positive for opioids
Slovenian: • če bolnik sam prizna jemanje heroina, drugih opioidov ali močne potrebe po tem in/ali če je vzorec urina pozitiven na opioide.
English: • evidence of implant coming out of the skin
Slovenian: • znaki, da implantat sili ven iz kože.
English: Exploratory surgery without knowledge of the exact location of all implants is strongly discouraged (see section 4.4).
Slovenian: Kirurški poseg brez predhodne natančne določitve lokacije vseh implantatov močno odsvetujemo (glejte poglavje 4.4).
English: • dehydration, increased appetite
Slovenian: • dehidracija, povečan apetit,
English: Respiratory and central nervous system (CNS) depression
Slovenian: Depresija dihanja in centralnega živčnega sistema
English: • decreased sexual desire, decreased orgasmic sensation
Slovenian: • zmanjšana spolna sla, zmanjšano občutenje orgazma,