natgillin/translations-raw huggingface dataset:
Exploratory surgery without knowledge of the exact location of all implants is strongly discouraged.
Kirurški poseg brez predhodne natančne določitve lokacije vseh implantatov močno odsvetujemo.
PHARMACEUTICAL FORM AND CONTENTS 4 implants
FARMACEVTSKA OBLIKA IN VSEBINA 4 implantati
Apply the sterile fenestrated drape to the patient's arm (Figure 4).
Na bolnikovo roko namestite sterilno fenestrirano prevleko (slika 4).
• The insertion and removal of Sixmo should take place under aseptic conditions.
• Zdravilo Sixmo je treba vstavljati in odstranjevati v aseptičnih pogojih.
• One applicator is used to insert all four implants.
• En aplikator se uporabi za vstavitev vseh štirih implantatov.
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).
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).
Buprenorphine may cause drowsiness, particularly when taken together with alcohol or CNS depressants (such as tranquilisers, sedatives or hypnotics) (see section 4.5).
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).
Buprenorphine undergoes N-dealkylation to its major pharmacologically active metabolite norbuprenorphine and subsequent glucuronidation.
Buprenorfin se N-dealkilira v svoj glavni farmakološko aktivni presnovek norbuprenorfin in se zatem glukuronidira.
Use the sterile gauze and apply gentle pressure to the incision site, for five minutes, to ensure haemostasis.
Uporabite sterilno gazo in pet minut nežno pritiskajte na mesto reza, da zagotovite hemostazo.
• surgical marker
• kirurški marker,
• in case of patient's self-reported heroin use, other opioid use or craving and/ or urine samples positive for opioids
• če bolnik sam prizna jemanje heroina, drugih opioidov ali močne potrebe po tem in/ali če je vzorec urina pozitiven na opioide.
• evidence of implant coming out of the skin
• znaki, da implantat sili ven iz kože.
Exploratory surgery without knowledge of the exact location of all implants is strongly discouraged (see section 4.4).
Kirurški poseg brez predhodne natančne določitve lokacije vseh implantatov močno odsvetujemo (glejte poglavje 4.4).
• dehydration, increased appetite
• dehidracija, povečan apetit,
Respiratory and central nervous system (CNS) depression
Depresija dihanja in centralnega živčnega sistema
• decreased sexual desire, decreased orgasmic sensation
• zmanjšana spolna sla, zmanjšano občutenje orgazma,
It has a relatively wide therapeutic window as a consequence of its partial agonist/antagonist properties, which attenuates suppression of cardiovascular and respiratory function.
Zaradi svojih delno agonističnih/antagonističnih lastnosti ima dokaj široko terapevtsko okno, kar zmanjšuje zaviralno delovanje na kardiovaskularno in respiratorno funkcijo.
The clinical experience with Sixmo in non-Caucasian patients is currently limited.
Klinične izkušnje z zdravilom Sixmo v populaciji nebelcev so trenutno omejene.
The patient alert card should mention:
Opozorilna kartica za bolnika mora vsebovati naslednje informacije:
Study PRO-806
Študija PRO-806
The primary efficacy endpoint in both studies was the cumulative distribution function (CDF) of the percentage of urine samples that were negative for illicit opioids (as evaluated through thrice weekly urine toxicology and patient self-reported opioid use).
Primarni opazovalni dogodek učinkovitosti v obeh študijah je bila kumulativna funkcija porazdelitve (CDF - cumulative distribution function) odstotka vzorcev urina, ki so bili negativni na prepovedane opioide (kot je bilo ocenjevano s toksikološkimi preiskavami urina trikrat tedensko in bolnikovim samoporočanjem o uporabi opioidov).
• Implant insertion and six-month removal date(s)
• datum vstavitve implantata ter datum njegove odstranitve po 6 mesecih;
Median (Range)
Mediana (razpon)
• phenobarbital, carbamazepine, phenytoin: medicines to treat epilepsy and other illnesses
• fenobarbital, karbamazepin, fenitoin: zdravila za zdravljenje epilepsije in drugih bolezni;
The opioid therapy must be provided by healthcare professionals trained in the use of anaesthetic medicinal products and the management of the respiratory effects of potent opioids, specifically the establishment and maintenance of a patent airway and assisted ventilation.
Terapijo z opioidi sme izvajati zdravstveni strokovnjak, ki je usposobljen za uporabo anestetičnih zdravil in za obvladovanje učinkov močnih opioidov na dihala, zlasti vzpostavljanje in ohranjanje prehodnosti zračnih poti in asistirane ventilacije.
• The incision site should be inspected for infection.
• Mesto reza je treba pregledati glede okužbe.
Both buprenorphine and norbuprenorphine can further undergo glucuronidation by UDPglucuronosyltransferases.
Tako buprenorfin kot tudi norbuprenorfin se lahko naknadno glukuronidirata z UDP-glukuronoziltransferazami.
Your doctor will examine the insertion site one week following implant insertion and at a minimum once-monthly thereafter for signs of:
Zdravnik bo pregledal mesto vstavitve en teden po vstavitvi implantata, zatem pa vsaj enkrat na mesec, pri čemer bo pozoren na naslednje:
Each dose consists of four implants, for subcutaneous insertion in the inner side of the upper arm.
En odmerek sestavljajo štirje implantati za subkutano vstavitev na notranji strani nadlakti.
Nevertheless, it is possible to extract the buprenorphine from the Sixmo implant.
Vendar pa je buprenorfin možno izvleči iz implantata Sixmo.
Improper insertions or infections may lead to protrusion or expulsion.
Nepravilna vstavitev ali okužba lahko povzroči protruzijo ali iztis.
CI=confidence interval, ITT=intent-to-treat, N=number of subjects, SE=standard error
IZ = interval zaupanja, ITT =populacija z namenom zdravljenja (intent-to-treat), n = število preiskovancev, SN = standardna napaka
• swelling, including tissue swelling in arms, legs or face caused by excess fluid
• otekanje, vključno z otekanjem tkiva v rokah, nogah ali na obrazu, ki ga povzroča odvečna tekočina,
Sixmo is provided in a carton.
Zdravilo Sixmo je pakirano v škatli.
There are no or limited data from the use of buprenorphine in pregnant women.
Podatkov o uporabi buprenorfina pri nosečnicah ni oziroma so omejeni.
Clean the removal site with an antiseptic solution, such as chlorhexidine.
Mesto odstranjevanja očistite z antiseptično raztopino, kot je klorheksidin.
Excessive touching of the implants or insertion site shortly after insertion may increase the chance of infection.
Prekomerno dotikanje implantata ali mesta vstavitve tik po vstavitvi lahko poveča tveganje za okužbo.
ITT=intent-to-treat Buprenorphine was not included in urine toxicology assessments.
Buprenorfin ni bil vključen v toksikološko ocenjevanje urina.
• period free from opioid drug abuse
• obdobje brez zlorabljanja opioidov,
• antiseptic solution, such as chlorhexidine
• antiseptična raztopina, kot je klorheksidin,
Subcutaneous insertion is essential to confirm proper placement by palpation.
Subkutana vstavitev je bistvena, da lahko s tipanjem potrdite primerno namestitev.
After one subcutaneous insertion in each arm (for a total of two treatments cycles), most patients should be transitioned back to their previous sublingual buprenorphine dose (i.e. the dose from which they were transferred to Sixmo treatment) for continued treatment.
Po eni subkutani vstavitvi v vsako roko (skupaj dva cikla zdravljenja), mora večina bolnikov spet začeti jemati odmerek podjezičnega buprenorfina (tj. odmerek, ki so ga prejemali ob prehodu na zdravljenje z zdravilom Sixmo) kot nadaljevalno zdravljenje.
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.