natgillin/translations-raw huggingface dataset:
Prior to entry into acute studies PRO-805, PRO-806, PRO-810 and TTP-400-02-01, patients were treatment naïve adults, with moderate to severe opioid dependency. 
Pred vstopom v akutne študije PRO-805, PRO-806, PRO-810 in TTP-400-02-01 so bili bolniki odrasle osebe, ki se še niso zdravile, z zmerno do hudo odvisnostjo od opioidov.
During clinical pharmacologic studies in opioid-dependent patients, buprenorphine shows ceiling effects on a number of PD and safety parameters. 
Med kliničnimi farmakološkimi študijami pri bolnikih, odvisnih od opioidov, je buprenorfin pokazal, da njegovi učinki pri določenem odmerku dosežejo najvišjo možno raven (ceiling effect), pri številnih farmakodinamičnih in varnostnih parametrih.
Patients should be warned that it is extremely dangerous to selfadminister non-prescribed benzodiazepines while taking this product, and should also be cautioned to use benzodiazepines concurrently with this product only as directed by their healthcare professional (see section 4.4). 
Bolnike je treba opozoriti, da je uporaba nepredpisanih benzodiazepinov na lastno pest med jemanjem tega zdravila izjemno nevarna in da je uporaba benzodiazepinov sočasno s tem zdravilom dovoljena samo v skladu z navodili njihovega zdravstvenega strokovnjaka (glejte poglavje 4.4).
Opioids may produce orthostatic hypotension in ambulatory patients. 
Opioidi lahko pri ambulantnih bolnikih povzročijo ortostatsko hipotenzijo.
Sixmo is not recommended for patients over 65 years. 
Zdravilo Sixmo ni priporočljivo za bolnike, starejše od 65 let.
• The holder of this card uses a buprenorphine only opioid dependence treatment called Sixmo. 
• Imetnik te kartice uporablja zdravilo za zdravljenje odvisnosti od opioidov, ki vsebuje samo buprenorfin in se imenuje Sixmo.
Patients in all groups were allowed to use supplemental sublingual buprenorphine to control potential withdrawal symptoms/cravings according to pre-specified criteria. 
Bolnikom v vseh skupinah je bilo dovoljeno jemanje podjezičnega buprenorfina za nadzorovanje morebitnih odtegnitvenih simptomov/močne potrebe po opioidih v skladu s predhodno določenimi kriteriji.
Two additional randomised, double-blind, placebo-controlled Phase 3 studies provide supportive data on efficacy and PK (Studies PRO-805 and PRO-806). 
Dve dodatni randomizirani, dvojno slepi in s placebom nadzorovani študiji 3. faze dajeta podporne podatke glede učinkovitosti in farmakokinetike (študiji PRO-805 in PRO-806).
• While using Sixmo, situations may arise where you need acute pain treatment or anaesthesia. 
• Med uporabo zdravila Sixmo lahko pride do situacij, ko boste potrebovali obvladovanje akutne bolečine ali anestezijo.
• mild or moderate liver problems 
• blage ali zmerne težave z jetri,
This product should be used with caution in patients with asthma or respiratory insufficiency (e.g. chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, 
To zdravilo je treba pri bolnikih z astmo ali respiratorno insuficienco (npr. kronično obstruktivno pljučno boleznijo, pljučnim srcem, zmanjšanim respiratornim rezervnim volumnom, hipoksijo,
Criteria for the use of supplemental sublingual buprenorphine It is possible that a subset of patients may require occasional supplemental sublingual buprenorphine support to achieve full control of opioid withdrawal symptoms and cravings, e.g. at times of personal stress or crisis. 
Kriteriji za uporabo dodatnega podjezičnega buprenorfina Podskupina bolnikov bo morda potrebovala občasno dodatno podporno zdravljenje s podjezičnim buprenorfinom zaradi doseganja popolnega nadzora nad odtegnitvenimi simptomi in močno potrebo po opioidih, npr. v primeru osebnega stresa ali krize.
In this study, approximately 75% of patients reported prescription opioids as the primary opioid of abuse, and 21% of patients reported heroin as the primary opioid of abuse. 
V tej študiji je približno 75 % bolnikov je kot primarne opioide, ki so jih zlorabljali, navajalo opioide na recept, 21 %
Therefore, the potential to overdose with a full agonist exists, especially when attempting to overcome buprenorphine partial agonist effects, or when buprenorphine plasma levels are declining (see section 4.4). 
Zato obstaja možnost prevelikega odmerjanja polnih agonistov, zlasti če želimo premagati delne agonistične učinke buprenorfina ali kadar plazemske koncentracije buprenorfina upadajo (glejte poglavje 4.4).
Plasma buprenorphine concentrations after Sixmo are illustrated in figure 3. 
Koncentracije buprenorfina v plazmi po vstavitvi zdravila Sixmo so prikazane na sliki 3.
Patients with mild to moderate hepatic impairment should be monitored for signs and symptoms of toxicity, or overdose caused by increased levels of buprenorphine (see section 4.2). 
Bolnike z blago do zmerno okvaro jeter je treba spremljati glede znakov in simptomov toksičnosti ali prevelikega odmerjanja, ki ga povzročajo povišane ravni buprenorfina (glejte poglavje 4.2).
A standard battery of genotoxicity tests conducted on extracts of Sixmo and ethylene vinyl acetate (EVA) placebo implants was negative. 
5.3 Predklinični podatki o varnosti Standardna serija preskusov genotoksičnosti, ki je bila opravljena na izvlečkih zdravila Sixmo in implantatov iz etilen vinil acetata, ki so vsebovali placebo, je bila negativna.
vomiting, tachycardia, hypertension, piloerection, dilated pupils; 
tahikardija, hipertenzija, piloerekcija, razširjene zenice;
Patients who discontinue treatment with Sixmo should be switched back to their previous dose of sublingual buprenorphine within 12 to 24 hours following removal of the Sixmo implants (i.e. the dose from which they were transferred prior to starting Sixmo treatment). 
Bolniki, ki prekinejo zdravljenje s zdravilom Sixmo, morajo preiti nazaj na svoj prejšnji odmerek podjezičnega buprenorfina v roku 12 do 24 ur po odstranitvi implantatov Sixmo (tj. odmerek, ki so ga prejemali ob prehodu na zdravljenje z zdravilom Sixmo).
The dissociation of buprenorphine from the µ-opioid receptors is expected to take up to several days after discontinuation of Sixmo treatment, which will prevent withdrawal symptoms immediately after removal of Sixmo. 
Ločevanje molekul buprenorfina od opioidnih receptorjev µ naj bi trajalo še več dni po prekinitvi zdravljenja z zdravilom Sixmo, kar prepreči takojšen pojav odtegnitvenih simptomov po odstranitvi implantatov Sixmo.
Priorities are the re-establishment of a patient and protected airway and institution of assisted ventilation, if needed. 
Prioritetne naloge so ponovna stabilizacija bolnika in zavarovanje dihalnih poti ter po potrebi uporaba asistirane ventilacije.
Location of implant: (upper arm: left / right) 
Datum odstranitve po 6 mesecih: Mesto implantata: (nadlaket: levo/desno)
Median age (range), years 
Mediana starosti (razpon), leta
• reduced adrenal gland function, such as Addison's disease 
• poslabšano delovanje nadledvične žleze, npr. Addisonovo bolezen,
Co-administration during buprenorphine treatment is contraindicated due to the potentially dangerous interaction that may precipitate a sudden onset of prolonged and intense opioid withdrawal symptoms (see section 4.3). 
Sočasna uporaba je med zdravljenjem z buprenorfinom kontraindicirana zaradi potencialno nevarnega medsebojnega delovanja, ki bi lahko sprožilo nenaden pojav dolgotrajnih in intenzivnih simptomov odtegnitve od opioidov (glejte poglavje 4.3).
Cardiac arrest or arrhythmias will require advanced life support techniques. 
V primeru zastoja srca ali aritmij so potrebne tehnike oživljanja.
In clinical studies and from post-marketing data 7 cases of clinically relevant implant breakage (breakage associated with an adverse reaction) were observed. 
kliničnih študijah in v obdobju po začetku trženja zdravila so v 7 primerih opazili klinično pomemben zlom implantata (zlom, povezan z neželenim učinkom).
Step 6: While lifting, gently advance the applicator subcutaneously along the channel marking on the skin. 
6. korak: Med dviganjem aplikator nežno potisnite subkutano vzdolž označenih kanalov na koži.
Buprenorphine is extensively metabolized in the liver. 
Buprenorfin se v veliki meri presnavlja v jetrih.
The incision should be made parallel to the axis of the arm, between the second and third implants, to access the subcutaneous space (Figure 15). 
Rez je treba narediti vzporedno z osjo roke, med drugim in tretjim implantatom, da omogočite dostop do subkutanega prostora (slika 15).
• Name and contact details of the treating physician 
• ime in kontaktni podatki lečečega zdravnika;
After determining that anaesthesia is adequate and effective, make a shallow incision 2.5 to 3 mm in length at incision site marking. 
Ko se prepričate, da je anestezija ustrezna in učinkovita, naredite plitev rez dolžine 2,5 do 3 mm vzdolž označenega mesta reza.
In study PRO-805, the primary endpoint was the CDF of the percentage of urine samples that were negative for illicit opioids over weeks 1 to 16, while the CDF over weeks 17 to 24 was evaluated as secondary endpoint. 
V študiji PRO-805 je bil primarni opazovalni dogodek CDF odstotka vzorcev urina, ki so bili negativni na prepovedane opioide od 1. do 16. tedna, medtem ko je bila CDF od 17. do 24. tedna ocenjevana kot sekundarni opazovani dogodek.
Buprenorphine has a mean elimination half-life from plasma ranging from 24 to 48 hours. 
Mediana razpolovne doba izločanja buprenorfina iz plazme znaša 24 do 48 ur.
One applicator is used to insert all four implants. 
En aplikator se uporabi za vstavitev vseh štirih implantatov.
Generally, breakage was not perceived as a safety concern to the patient by the investigator. 
Na splošno raziskovalec zlomov implantata ni ocenil kot varnostno tveganje za bolnika.
Schedule an appointment for the sutures to be removed. 
Dogovorite se za naslednji termin, da boste odstranili šive.
• The other ingredient is ethylene vinyl acetate copolymer. 
• Druga sestavina zdravila je kopolimer etilen vinil acetata.
When used during pregnancy, particularly late pregnancy, buprenorphine may cause withdrawal symptoms, including breathing problems, in the newborn baby. 
Če ga uporabljate med nosečnostjo, zlasti v pozni nosečnosti, lahko buprenorfin pri novorojenem otroku povzroči odtegnitvene simptome, tudi težave z dihanjem.
• The patient should be instructed to place the implant in a glass jar with a lid, store it safely away from others, especially children, and bring it to the healthcare professional to determine whether the full implant has been expelled. 
• Bolniku je treba naročiti, naj implantat da v steklen kozarec s pokrovom in ga varno shrani zunaj dosega drugih oseb, zlasti otrok, ter ga prinese zdravstvenemu strokovnjaku, ki bo ocenil,
• It is recommended that the healthcare professional is in a seated position during the entire insertion procedure so that the insertion site and the movement of the needle under the skin can be clearly seen from the side. 
• Priporočljivo je, da je zdravstveni strokovnjak med celotnim postopkom vstavljanja v sedečem položaju, tako da lahko s strani jasno vidi mesto vstavitve in premikanje igle pod kožo.
If continued treatment is desired at the end of the first six-month treatment cycle, a new set of 4 Sixmo implants may be administered following removal of the old implants for one additional treatment cycle of six months. 
Če je ob koncu prvega šestmesečnega cikla zdravljenja zaželeno nadaljevanje zdravljenja, lahko po odstranitvi starih implantatov vstavite nov komplet 4 implantatov Sixmo za en dodatni cikel šestmesečnega zdravljenja.
In Studies PRO-805 and PRO-806, 62.0% and 39.5% of Sixmo-treated subjects required supplemental SL buprenorphine. 
V študijah PRO-805 in PRO-806 je 62,0 % oz. 39,5 % preiskovancev, ki so dobili zdravilo Sixmo, potrebovalo dodatni SL BPN.
Mean steady-state plasma buprenorphine concentrations were consistent across all clinical studies, at approximately 0.5 to 1 ng/mL (with the 4-implant dose), and were maintained for approximately 20 weeks (week 4 through week 24) in a 24-week treatment period. 
Povprečne plazemske koncentracije buprenorfina v stanju dinamičnega ravnovesja so bile podobne v vseh kliničnih študijah in so znašale približno 0,5 do 1 ng/ml (z odmerkom 4 implantatov) ter so se obdržale približno 20 tednov (od 4. tedna do 24. tedna) v
There are no or limited data on effects of buprenorphine on human fertility (see section 5.3). 
Podatkov o učinkih buprenorfina na plodnost pri ljudeh ni oziroma so omejeni (glejte poglavje 5.3).
Other medicines and Sixmo 
Druga zdravila in zdravilo Sixmo
• reactions at the implant site pain, itching procedural site reaction, such as pain during the insertion procedure bruising, skin reddening, scar bleeding 
• reakcije na mestu implantata: bolečina, srbenje, reakcija na mestu postopka, kot je bolečina med postopkom vstavljanja, modrice, pordelost kože, brazgotina, krvavitev.
Long-term administration of buprenorphine during the last three months of pregnancy may cause a withdrawal syndrome in the neonate (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus or convulsions). 
Dolgotrajna uporaba buprenorfina v zadnjih treh mesecih nosečnosti lahko pri novorojencu povzroči odtegnitveni sindrom (npr. hipertonijo, neonatalni tremor, neonatalno agitacijo, mioklonus ali konvulzije).
Sixmo was shown to be noninferior to sublingual buprenorphine, the proportion of responders being 87.6% in the sublingual buprenorphine and 96.4% in the Sixmo group. 
Zdravilo Sixmo se je izkazalo kot neiferiorno podjezičnemu buprenorfinu, delež bolnikov z odzivom je bil 87,6 % v skupini s podjezičnim buprenorfinom in 96,4 % v skupini z zdravilom Sixmo.
In a subset of patients, Sixmo implants broke during implant removal. 
V podskupini bolnikov se je implantat med odstranjevanjem zlomil.
Treatment of acute pain during Sixmo therapy 
Zdravljenje akutne bolečine med zdravljenjem z zdravilom Sixmo
• Implants are located under the skin, at the inner side of the upper arm. 
• Implantati so vstavljeni pod kožo, na notranji strani nadlakti.
If implants are placed too deeply (intramuscular or in the fascia) this may lead to neural or vascular injury upon insertion or removal. 
Če so implantati vstavljeni pregloboko (intramuskularno ali v mišično ovojnico), lahko med vstavljanjem ali odstranjevanjem pride do poškodb živcev ali žilja.
• Contact your doctor if you experience any unusual symptoms, such as breathing problems, head injury, increased pressure in the head. 
• Če opazite kakršne koli nenavadne simptome, kot so težave z dihanjem, poškodba glave,
Each dose consists of 4 implants. 
En odmerek vsebuje 4 implantate.
While applying counter-traction to the skin, at a slight angle (no greater than 20 degrees), insert only the tip of the applicator into the subcutaneous space (depth of 3 to 4 mm below the skin), with the bevel-up stop marking on the cannula facing upwards and visible with the obturator locked fully into the cannula (Figure 5). 
Medtem ko kožo vlečete v nasprotni smeri, pod majhnim kotom (ki ni večji od 20 stopinj) vstavite samo konico aplikatorja v subkutani prostor (globina 3 do 4 mm pod kožo), pri tem pa naj bo, pri navzgor obrnjeni poševnini konice oznaka za ustavitev na kanili obrnjena navzgor in vidna, ko je mandren popolnoma pritrjen na kanili (slika 5).
White/Off-white to pale yellow, rod-shaped implant, 26.5 mm long and 2.4 mm in diameter. 
Bel/belkast do bledo rumen implantat v obliki paličice, z dolžino 26,5 mm in premerom 2,4 mm.
Serious complications from insertion and removal of Sixmo implants 
Resni zapleti zaradi vstavljanja ali odstranjevanja implantatov Sixmo
Buprenorphine is a partial agonist at the µ (mu)-opioid receptor and chronic administration produces dependence of the opioid type. 
Buprenorfin je delni agonist opioidnega receptorja µ (mu), tako da kronično dajanje lahko povzroči odvisnost od opioidov.
Towards the end of pregnancy buprenorphine may induce respiratory depression in the newborn infant even after a short period of administration. 
Proti koncu nosečnosti buprenorfin lahko sproži depresijo dihanja pri novorojencu tudi pri kratkotrajni uporabi.
After the initial buprenorphine peak, the plasma buprenorphine concentrations decreased slowly and steady-state plasma buprenorphine concentrations were reached by approximately week 4. 
Po začetnem višku buprenorfina so se koncentracije buprenorfina v plazmi počasi zmanjševale in so dosegle stanje dinamičnega ravnovesja do približno 4. tedna.
Grasp the centre of the implant with the X-plant clamp(s) (Figure 17) and apply gentle traction. 
Implantat primite na sredini s sponko/sponkami X-plant (slika 17) in nežno povlecite.
If the implants cannot be located, the doctor may use ultrasound or a type of scan called magnetic resonance imaging (MRI). 
Če implantata ni mogoče locirati, bo zdravnik morda uporabil ultrazvok ali vrsto preiskave, ki ji pravimo magnetnoresonančno slikanje
What Sixmo looks like and contents of the pack 
Izgled zdravila Sixmo in vsebina pakiranja
Adverse reactions (implant and non-implant) reported are listed in the following table. 
Neželeni učinki (povezani z implantatom in nepovezani z implantatom), o katerih so poročali, so navedeni v spodnji preglednici.
• urinary hesitation, urge to urinate, urinating more frequently with little urinary output 
• težave z začetkom mokrenja, nujna potreba po uriniranju, pogostejše uriniranje z malo izločenega urina,
• have severe breathing problems 
• če imate hude težave z dihanjem;
Concomitant administration of opioid antagonists (naltrexone, nalmefene) for the treatment of alcohol or opioid dependence 
Sočasna uporaba antagonistov opioidov (naltrekson, nalmefen) za zdravljenje odvisnosti od alkohola ali opioidov
The European Medicines Agency has waived the obligation to submit the results of studies with Sixmo in all subsets of the paediatric population for the maintenance treatment of opioid dependence (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Sixmo za vse podskupine pediatrične populacije pri vzdrževalnem zdravljenju odvisnosti od opioidov
It is recommended that the healthcare professional is in a seated position during the entire insertion procedure so that the insertion site and the movement of the needle just under the skin can be clearly seen from the side. 
Priporočljivo je, da je zdravstveni strokovnjak med celotnim postopkom vstavljanja v sedečem položaju, tako da lahko s strani jasno vidi mesto vstavitve in premikanje igle tik pod kožo.
• fatigue, chills, weakness, increased muscle tone 
• utrujenost, mrzlica, šibkost, povečanje mišičnega tonusa,
Patients receiving Sixmo should be closely monitored for signs of toxicity if combined with potent CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, nelfinavir or indinavir, or azole antifungals such as ketoconazole and itraconazole, or macrolide antibiotics). 
Bolnike, ki uporabljajo zdravilo Sixmo, je treba pozorno spremljati glede znakov toksičnosti, če sočasno jemljejo močne zaviralce encima CYP3A4 (npr. zaviralce proteaze, kot so ritonavir, nelfinavir ali indinavir, ali azolske antimikotike, kot so ketokonazol in itrakonazol, ali makrolidne antibiotike).
• pain and dysfunction of chewing muscles and joints called temporomandibular joint syndrome 
• bolečina in nedelovanje žvečilnih mišic in sklepov, kar imenujemo sindrom temporomandibularnega sklepa,
The primary endpoint was proportion of responders, defined as patients with no more than 2 of 6 months with evidence of illicit opioid use based on a composite of both urine and self-report results. 
Primarni opazovani dogodek je bil delež bolnikov z odzivom, opredeljenih kot bolniki, ki so uporabljali prepovedane opioide manj kot 2 od 6 mesecev, na podlagi rezultatov urinskih testov in bolnikovega samoporočanja.
Non-palpable implants must be located prior to attempted removal. 
Implantate, ki jih ne morete zatipati, je treba najprej poiskati, preden se lotite postopka odstranjevanja.
In a pharmacokinetic study with sublingual buprenorphine, buprenorphine plasma levels were found to be higher and the half-life was found to be longer in patients with moderate and severe hepatic impairment, but not in patients with mild hepatic impairment (see section 5.2). 
V farmakokinetični študiji podjezičnega buprenorfina so bile pri bolnikih z zmerno do hudo okvaro jeter ugotovljene višje ravni buprenorfina v plazmi in daljša razpolovna doba, česar pa niso opazili pri bolnikih z blago okvaro jeter (glejte poglavje 5.2).
Name and address of the manufacturer of the active substance 
Ime in naslov izdelovalca biološke učinkovine
Sixmo is contraindicated in patients with severe hepatic impairment. 
Zdravilo Sixmo je kontraindicirano pri bolnikih s hudo okvaro jeter.
• An appointment for the patient should be scheduled to return to the inserting healthcare professional as soon as possible. 
• Bolniku je treba čim prej dati termin pri zdravstvenem strokovnjaku, ki izvaja postopek vsaditve.
• cellulitis, skin infection, boil 
• celulitis, okužba kože, tur,
After determining the anaesthesia is adequate and effective, make a 7 to 10 mm incision with a scalpel, parallel to the axis of the arm, between the second and third implants. 
Ko se prepričate, da je anestezija ustrezna in učinkovita, s skalpelom naredite rez dolžine 7 do 10 mm vzporedno z osjo roke,
Supportive measures (including oxygen, vasopressors) should be employed in the management of circulatory shock and pulmonary oedema as indicated. 
Pri obvladovanju cirkulatornega šoka in pljučnega edema je treba uporabiti podporne ukrepe (vključno s kisikom, vazopresorimi sredstvi), kot je indicirano.
Infection may occur at the site of the insertion or removal. 
Na mestu vstavitve ali odstranjevanja se lahko pojavi okužba.
Having the patient flex the biceps muscle may facilitate identification of the site (Figure 2). 
Če bolnik napne dvoglavo mišico, je lažje prepoznati mesto vstavitve (slika 2).
Study PRO-806 had two co-primary endpoints, which were the CDF of the percentage of urine samples that were negative for illicit opioids for Weeks 1 to 24 in the Sixmo and placebo groups (coprimary 1), and the CDF of the percentage of urine samples that were negative for illicit opioids for Weeks 1 to 24 in the Sixmo and placebo groups, with imputation based on illicit drug self-report data (co-primary 2). 
Študija PRO-806 je imela dva primarna sočasno opazovana dogodka - CDF odstotka vzorcev urina, ki so bili negativni na prepovedane opioide, od 1. do 24. tedna v skupini z zdravilom Sixmo in skupini s placebom (primarni sočasno opazovani dogodek 1), in CDF odstotka vzorcev urina, ki so bili negativni na prepovedane opioide, od 1. do 24. tedna v skupini z zdravilom Sixmo in skupini s placebom na podlagi podatkov samoporočanja o jemanju prepovedanih drog (primarni sočasno opazovani dogodek 2).
If the implants are inserted deeply, it is possible that neurovascular injury may occur. 
Če so implantati vstavljeni globoko, lahko pride do poškodb živcev ali žilja.
Table 2: Patient characteristics in the studies PRO-805 and PRO-806 Study PRO-805 
Preglednica 2: Značilnosti bolnikov v študijah PRO-805 in PRO-806
Step 9: Redirect the applicator to the next channel marking, while stabilizing the previously inserted implant with your index finger, away from the sharp tip (Figure 13). 
9. korak: Aplikator preusmerite na naslednji označeni kanal, pri tem pa predhodno vstavljeni implantat držite s kazalcem proč od ostre konice (slika 13).
Patients who may not be investigated using a magnetic resonance imaging (MRI) scan must not be allowed to receive Sixmo. 
Bolniki, pri katerih preiskava z magnetnoresonančnim slikanjem (MRI) ni dovoljena, ne smejo uporabljati zdravila Sixmo.
Anaesthetise the insertion area at the incision site and just under the skin, along the planned insertion channels, by injecting 5 mL lidocaine 1% with adrenaline 1:100,000. 
Mesto vstavitve in predel tik pod kožo vzdolž predvidenih kanalov za vstavljanje anestezirajte tako, da injicirate 5 ml 1 % lidokaina z adrenalinom 1 : 100.000.
Sixmo is not recommended for children under 18 years. 
Otroci in mladostniki Zdravilo Sixmo ni priporočljivo za otroke, mlajše od 18 let.