natgillin/translations-raw huggingface dataset:
• medicines to treat fungal infections, like thrush, with active substance names ending in “azole”, such as ketoconazole, itraconazole, fluconazole
• zdravila za zdravljenje glivičnih okužb, npr. kandidoze, ki vsebujejo učinkovino, katere ime se konča na „azol“, kot so ketokonazol, itrakonazol, flukonazol;
Sixmo implants are intended to be in place for 6 months and provide a continuous delivery of buprenorphine.
Implantati Sixmo so predvideni za vstavitev za 6 mesecev in stalno dovajajo buprenorfin.
Step 1: The patient should lie on their back, with the intended arm flexed at the elbow and externally rotated, so that the hand is positioned next to the head.
1. korak: Bolnik naj leži na hrbtu, roka naj bo v komolcu upognjena in obrnjena navzven, tako da je dlan poleg glave.
Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.
4.1 Terapevtske indikacije Zdravilo Sixmo je indicirano za nadomestno zdravljenje odvisnosti od opioidov v okviru medicinskega, socialnega in psihološkega zdravljenja pri klinično stabilnih odraslih bolnikih, ki ne potrebujejo več kot 8 mg/dan podjezičnega buprenorfina.
Patients who develop hepatic impairment while being treated with Sixmo should be monitored for signs and symptoms of toxicity or overdose.
Če se pri bolnikih okvara jeter pojavi med zdravljenjem z zdravilo Sixmo, je treba te bolnike spremljati glede znakov in simptomov toksičnosti ali prevelikega odmerjanja.
Sixmo is a white/off-white to pale yellow rod-shaped implant, 26.5 mm long and 2.4 mm in diameter.
Zdravilo Sixmo je bel/belkast do bledo rumen implantat v obliki paličice, z dolžino 26,5 mm in premerom 2,4 mm.
• If the expelled implant is not intact, the healthcare professional should palpate the insertion location to identify the location of any remaining partial implant.
• Če iztisnjeni implantat ni cel, mora zdravstveni strokovnjak s tipanjem pregledati mesto vstavitve, da poišče lokacijo drugega dela implantata.
Adverse drug reactions were categorized as implant or non-implant adverse reactions.
Neželeni učinki zdravila so bili razvrščeni kot neželeni učinki, povezani z implantatom ali nepovezani z implantatom.
Opioids should be used with caution in patients with myxoedema, hypothyroidism or adrenal cortical insufficiency (e.g. Addison's disease).
Pri uporabi opioidov pri bolnikih z miksedemom, hipotiroidizmom ali adrenokortikalno insuficienco (na primer Addisonova bolezen) je potrebna previdnost.
The treating physician should consider implant removal if:
Kriteriji za prekinitev zdravljenja Lečeči zdravnik mora o odstranitvi implantata razmisliti v naslednjih primerih:
If spontaneous expulsion of the implant occurs after insertion, the following steps should be taken:
Če po vstavitvi pride do spontanega iztisa implantata, je treba storiti naslednje:
Counsel the patient on proper aseptic wound care.
Bolniku svetujte, kako naj ustrezno aseptično neguje rano.
Naloxone may be of value for the management of buprenorphine overdose.
Nalokson lahko pomaga pri obvladovanju prevelikega odmerjanja buprenorfina.
Pups born tended to weigh less on postnatal day 1 compared with controls.
Skoteni mladiči so 1. ponatalni dan v primerjavi s kontrolami v večini primerov tehtali manj.
Apply the sterile drape to the patient's arm. Anaesthetise the incision site and the subcutaneous space containing the implants (for example, by injecting 5 to 7 mL lidocaine 1% with adrenaline 1:100,000).
Mesto reza in subkutani prostor, kjer so implantati, anestezirajte (na primer z injiciranjem 5 do 7 ml 1 % lidokaina z adrenalinom 1 : 100.000).
Retract the applicator, bevel-up, until the distal marking of the cannula is visible at the incision opening (the sharp tip remaining in the subcutaneous space).
Aplikator s poševnino konice navzgor vlecite nazaj, dokler distalna oznaka kanile ni vidna na odprtini reza (ostra konica ostaja subkutano).
Sixmo implants must be inserted, removed, and patients monitored by a healthcare professional familiar with the procedure, with experience in the management of opioid addiction.
Vstavljanje in odstranjevanje implantatov Sixmo ter spremljanje bolnika mora izvajati zdravstveni strokovnjak, ki je seznanjen s postopkom in ima izkušnje z obvladovanjem odvisnosti od opioidov.
Instruct the patient that the pressure bandage can be removed after 24 hours and the adhesive bandage removed in three to five days, and to apply an ice pack on the arm for 40 minutes every two hours for the first 24 hours, then as needed.
Bolniku povejte, da lahko kompresijski povoj sname po 24 urah, obliž pa po treh do petih dneh, ter da naj v prvih 24 urah na roki drži ledeni obkladek 40 minut vsaki dve uri, kasneje pa po potrebi.
No recommendation on posology can be made.
Poročil o odmerjanju ni mogoče dati.
• Benzodiazepines: This combination may result in death due to respiratory depression of central origin.
Buprenorfin je treba uporabljati previdno pri sočasnem dajanju z: • benzodiazepini: ta kombinacija lahko povzroči smrt zaradi depresije dihanja centralnega izvora.
• liquid adhesive
• tekoči adheziv,
Sixmo should also be administered with caution in patients with a history of connective tissue disease (e.g. scleroderma) or history of recurrent methicillin-resistant Staphylococcus aureus infections.
Pri dajanju zdravila Sixmo je potrebna previdnost tudi pri bolnikih, ki imajo v svoji anamnezi bolezen vezivnega tkiva (npr. skleroderma) ali ponavljajoče okužbe z bakterijo Staphylococcus aureus, odporno proti metilicinu.
The Sixmo PK was assessed in opioid-dependent patients treated with Sixmo in studies TTP-400-0201, PRO-810, PRO-805, PRO-806, PRO-807 and PRO-811.
Farmakokinetične lastnosti zdravila Sixmo so ocenjevali pri bolnikih, odvisnih od opioidov, ki so se zdravili z zdravilom Sixmo v študijah TTP-400-02-01, PRO-810, PRO-805, PRO-806, PRO-807 in PRO-811.
• 4 Sixmo implants
• 4 implantati Sixmo,
Sixmo is not recommended during pregnancy, nor in women of childbearing age not using contraception.
Uporaba zdravila Sixmo ni priporočljiva med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
Sixmo is contraindicated in patients with a history of keloid or hypertrophic scar formation at the site where Sixmo would be implanted, as difficulties in retrieving the implant are possible (see section
Zdravilo Sixmo je kontraindicirano pri bolnikih, ki imajo v svoji anamnezi keloidno ali hipertrofično brazgotinjenje na mestu, kjer bi bilo treba vstaviti implantate Sixmo, saj bi se pri odstranjevanju implantatov lahko pojavile težave (glejte poglavje 4.3).
LIST OF EXCIPIENTS Excipient: Ethylene vinyl acetate copolymer
SEZNAM POMOŽNIH SNOVI Pomožna snov: kopolimer etilen vinil acetata
PATIENT ALERT CARD
OPOZORILNA KARTICA ZA BOLNIKA
Figure 3: Plasma buprenorphine concentrations after insertion of Sixmo (concentrations up to day 28 are based on study PRO-810, while concentrations after day 28 are based on studies PRO-805, PRO-806, PRO-807 and PRO-811)
Slika 3: Koncentracije buprenorfina v plazmi po vstavitvi zdravila Sixmo (koncentracije do 28. dneva temeljijo na študiji PRO-810, koncentracije po 28. dnevu pa na študijah PRO-805, PRO-806, PRO-807 in PRO-811)
The mortality index was significantly increased in the buprenorphine groups.
Stopnja umrljivosti je bila v skupini z buprenorfinom pomembno zvišana.
If another set of implants is not inserted on the same day as the previous set is removed: A dose of between 2 and 8 mg buprenorphine daily, given under the tongue, is recommended until repeat treatment occurs.
Če vam ne vstavijo novega kompleta implantatov isti dan, ko so vam odstranili stare: Priporočljiva je uporaba odmerka od 2 do 8 mg na dan, ki se daje pod jezik, dokler vam ne uvedejo ponovnega zdravljenja.
Ask your doctor or pharmacist for advice in these cases.
V teh primerih se posvetujte z zdravnikom ali farmacevtom.
Treatment must be under the supervision of a healthcare professional experienced in the management of opioid dependence/addiction.
Zdravljenje mora potekati pod nadzorom zdravstvenega strokovnjaka, ki ima izkušnje z zdravljenjem odvisnosti od opioidov oz. z zasvojenostjo z opioidi.
• Opioid analgesics: Adequate analgesia may be difficult to achieve when administering a full opioid agonist in patients receiving buprenorphine.
• opioidnimi analgetiki: pri bolnikih, ki prejemajo buprenorfin in jim damo polne opioidne agoniste, je težko doseči zadostno analgezijo.
hypotension, respiratory depression);
hipotenzijo, depresijo dihanja in smrt.
While on Sixmo, situations may arise where patients need acute pain management or anaesthesia.
Med zdravljenjem z zdravilom Sixmo lahko pride do situacij, ko bodo bolniki potrebovali obvladovanje akutne bolečine ali anestezijo.
Reproductive system and breast disorders uncommon dysmenorrhoea, erectile dysfunction
Motnje reprodukcije in dojk občasni dismenoreja, erektilna disfunkcija
Risk of serious complications of insertion and removal of implants Rare but serious complications including nerve damage and migration resulting in embolism and death may result from improper insertion of drug implants (see section 4.4).
Redki, toda hudi zapleti, vključno s poškodbo živcev in migracijo, katere posledica sta embolija in smrt, so lahko posledica nepravilne vstavitve zdravila v obliki implantatov (glejte poglavje 4.4).
Figure 2: Cumulative Distribution Function of the Percentage of Urine Samples Negative for Opioids in Weeks 1-24 (co-primary endpoint 1), Study PRO-806 (ITT Population)
Slika 2: Kumulativna funkcija porazdelitve v odstotkih vzorcev urina, ki so bili negativni na opioide, od 1. do 24. tedna (primarni sočasno opazovani dogodek 1), študija PRO-806 (populacija ITT)
• insertion site and date
• mesto in datum vstavitve,
If implants for repeat treatment are not inserted on the same day as removal of previous implants, individuals should be maintained on a fixed dose of 2 to 8 mg/day of sublingual buprenorphine, as clinically indicated, until repeat treatment occurs.
Če implantatov za ponovljeno zdravljenje ne vstavite isti dan, ko ste odstranili prejšnje implantate, je treba posameznikom do uvedbe ponovljenega zdravljenja dajati fiksni odmerek od 2 do 8 mg/dan podjezičnega buprenorfina, kot je klinično indicirano.
• drug withdrawal syndrome, such as sweating, feeling hot and cold
• sindrom odtegnitve od drog, na primer potenje, občutek vročine ali mraza,
Please attend all of these necessary appointments.
Držite se vseh potrebnih terminov pri zdravniku.
Instruct the patient to apply an ice pack to the arm for 40 minutes every two hours for first 24 hours, then as needed.
Bolniku naročite, naj v prvih 24 urah na roki drži ledeni obkladek 40 minut vsaki dve uri, kasneje pa po potrebi.
Sixmo contains the active substance buprenorphine, which is a type of opioid medicine.
Kaj je zdravilo Sixmo in za kaj ga uporabljamo Zdravilo Sixmo vsebuje učinkovino buprenorfin, ki je vrsta opioidnega zdravila.
Precipitation of opioid withdrawal syndrome
Povzročitev sindroma odtegnitve od opioidov
Buprenorphine is extensively metabolized in the liver and increased plasma levels were found to be increased in patients with moderate and severe hepatic impairment.
Buprenorfin se v veliki meri presnavlja v jetrih, pri bolnikih z zmerno do hudo okvaro jeter so bile opažene povišane ravni v plazmi.
• minimal to no desire or need to abuse opioids
• minimalna želja/potreba po jemanju opioidov ali odsotnost te želje/potrebe,
• medicines which calm, induce sleep or relax muscles, with active substance names ending with “azepam” This combination may result in death due to breathing depression.
• zdravila za pomiritev, uspavanje ali za sproščanje mišic in vsebujejo učinkovino, katere ime se konča na „azepam“;
Caution is recommended when dosing patients with severe renal impairment (creatinine clearance < 30 mL/min) (see sections 4.2 and 5.2).
Pri odmerjanju pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) je priporočljiva previdnost (glejte poglavji 4.2 in 5.2).
Risk of expulsion
Tveganje iztisa
In urine, most of the buprenorphine and norbuprenorphine was conjugated (buprenorphine: 1% free and 9.4% conjugated; norbuprenorphine: 2.7% free and 11% conjugated).
prostega in 9,4 % konjugiranega; norbuprenorfin: 2,7 % prostega in 11 % konjugiranega).
Instruct the patient that the pressure bandage can be removed after 24 hours and the adhesive bandage in three to five days.
Bolniku povejte, da lahko kompresijski povoj sname po 24 urah, obliž pa po treh do petih dneh.
Table 5: Implant breakage in Sixmo double-blind Phase 3 studies Current technique and training PRO-806
Preglednica 5: Zlom implantata v dvojno slepih študijah zdravila Sixmo 3. faze
Figure 1: Cumulative Distribution Function of the Percentage of Urine Samples Negative for Opioids in Weeks 1-16, Study PRO-805 (ITT)
Slika 1: Kumulativna funkcija porazdelitve v odstotkih vzorcev urina, ki so bili negativni na opioide, od 1. do 16. tedna, študija PRO-805 (ITT)
If Sixmo implants are not immediately replaced upon removal, patients should be maintained on sublingual buprenorphine (2 to 8 mg/day), as clinically indicated, until Sixmo treatment is resumed.
Če implantatov Sixmo ne zamenjate takoj po odstranitvi, morajo bolniki do nadaljevanja zdravljenja z zdravilom Sixmo prejemati podjezični buprenorfin (2 do 8 mg/dan), kot je klinično indicirano.
Apply an ice pack on the arm for 40 minutes every two hours for the first 24 hours, then as needed.
V prvih 24 urah na roki držite ledeni obkladek 40 minut vsaki dve uri, kasneje pa po potrebi.
• alcohol pad
• alkoholna blazinica,
Caution is recommended when dosing patients with severe renal impairment (creatinine clearance < 30 mL/min) (see sections 4.4 and 5.2).
Pri odmerjanju pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) je priporočljiva previdnost (glejte poglavji 4.4 in 5.2).
• 1 implant applicator
• 1 aplikator za implantate.
• Avoid moving implants around under the skin or gain a lot of weight after insertion of Sixmo as this may make it difficult to locate implants.
• Po vstavitvi zdravila Sixmo ne premikajte implantatov pod kožo in ne pridobite preveč na telesni masi, saj bi zaradi tega lahko otežili iskanje implantatov ob odstranjevanju.
Treatment with Sixmo
Zdravljenje z zdravilom Sixmo
• A number of cases of death due to breathing depression have been reported while on buprenorphine.
• Med uporabo buprenorfina so poročali o številnih primerih smrti zaradi depresije dihanja.
• clarithromycin, erythromycin, troleandomycin: medicines to treat bacterial infections
• klaritromicin, eritromicin, troleandomicin: zdravila za zdravljenje bakterijskih okužb; • nefazodon: zdravilo za zdravljenje depresije;
If pregnancy occurs during treatment with Sixmo the benefit to the patient should be weighed against the risk to the foetus.
Če med zdravljenjem z zdravilo Sixmo ženska zanosi, je treba pretehtati koristi za bolnico in tveganja za plod.
• fever, feeling cold, discomfort
• zvišana telesna temperatura, občutek mraza, nelagodje,
* Implant site adverse drug reaction (*) Observed as implant and non-implant site adverse drug reaction ** Reported with other approved buprenorphine only medicinal product *** Post-marketing data only
(*) Opaženo kot neželeni dogodek v povezavi z mestom implantata ali brez povezave z mestom implantata ** Poročano pri uporabi drugih odobrenih zdravil, ki vsebujejo samo buprenorfin
Preparations for handling or administering the medicinal product
Subkutana uporaba Priprava na ravnanje z zdravilom ali dajanje zdravila
Step 8: While holding the obturator in place on the arm, retract the cannula along the obturator, leaving the implant in place (Figure 11).
8. korak: Medtem ko mandren držite pri miru na nadlakti, kanilo vlecite nazaj vzdolž mandrena, s čimer bo implantat ostal na mestu (slika 11).
The mean doses per week in Sixmo subjects in PRO-805 and PRO-806 studies were 5.16 mg and 3.16 mg, with relatively low mean days of use per week of 0.45 and 0.31, respectively.
V študijah PRO-805 in PRO-806 je bil povprečni odmerek na teden pri osebah, zdravljenih z zdravilom Sixmo, 5,16 mg oz. 3,16 mg, z relativno nizkim povprečnim številom
New implants will be inserted in the other arm.
Najbolje je nove implantate vstaviti še isti dan. Novi implantati se vstavijo v drugo roko.
Step 3: Put on sterile gloves and check the function of the implant applicator by removing the obturator from the cannula and relocking it. Clean the insertion site with an antiseptic solution, such as chlorhexidine.
3. korak: Nadenite si sterilne rokavice in preverite delovanje aplikatorja za implantate tako, da odstranite mandren iz kanile in ga znova vstavite.
Using the surgical marker, mark the location of the implants and the location of the incision.
S kirurškim markerjem označite mesto implantatov in mesto reza.
• changes in blood levels increased enzyme levels: aspartate aminotransferase, gamma-glutamyltransferase, blood lactate dehydrogenase, lipase, amylase decreased enzyme levels: alkaline phosphatase increased bicarbonate level increased bilirubin level - a yellow breakdown substance of the blood pigment increased glucose level decreased cholesterol level decreased haematocrit - the percentage of blood cells on the blood volume decreased haemoglobin - the red blood cell pigment, increased mean cell haemoglobin increase in certain white blood cell count: monocyte, neutrophils decreased cell count: platelets, red blood cells, lymphocytes
• spremembe vrednosti v krvi: zvišanje ravni encimov: aspartat-aminotransferaze, gama-glutamiltransferaze, laktat dehidrogenaze v krvi, lipaze, amilaze, znižanje ravni encimov: alkalne fosfataze, zvišanje ravni bikarbonata, zvišanje ravni bilirubina - rumena snov, ki nastaja pri razgradnji krvnega pigmenta, zvišanje ravni krvnega sladkorja, znižanje ravni holesterola,
Follow steps 6 through 9 for the insertion of the three remaining implants through the same incision.
Za vstavljanje preostalih treh implantatov skozi isti rez glejte 6. do 9. korak.
Few cases of protrusion or expulsion of implants, mainly attributed to improper insertion technique, were reported in clinical studies with Sixmo (see section 4.4).
V kliničnih študijah zdravila Sixmo so poročali o nekaj primerih protruzije ali iztisa implantatov, kar so v večini primerov pripisali nepravilni tehniki vstavitve (glejte poglavje 4.4).
Investigations common alanine aminotransferase increased uncommon aspartate aminotransferase increased, weight decreased, blood lactate dehydrogenase increased, gamma-glutamyl-transferase increased, weight increased, blood alkaline phosphatase decreased, amylase increased, blood bicarbonate increased, blood bilirubin increased, blood cholesterol decreased, blood glucose increased, haematocrit decreased, haemoglobin decreased, lipase increased, lymphocyte count decreased, mean cell haemoglobin increased, mean cell volume abnormal, monocyte count increased, neutrophil count increased, platelet count decreased, red blood cell count decreased
Preiskave pogosti zvišanje alanin-aminotransferaze občasni zvišanje aspartat-aminotransferaze, zmanjšanje telesne mase, zvišanje laktat dehidrogenaze v krvi, zvišanje gama-glutamil-transferaze, povečanje telesne mase, znižanje alkalne fosfataze v krvi, zvišanje amilaze, zvišanje bikarbonata v krvi, zvišanje bilirubina v krvi, znižanje holesterola v krvi, zvišanje glukoze v krvi, znižanje hematokrita, znižanje hemoglobina, zvišanje lipaze, zmanjšano število limfocitov,
Vascular disorders common hot flush, vasodilatation**, hypertension**
Žilne bolezni pogosti vročinski oblivi, vazodilatacija**, hipertenzija**
What Sixmo contains
Kaj vsebuje zdravilo Sixmo
Retention in treatment was high in the Sixmo groups, with 65.7% and 64.0% of patients completing studies PRO-805 and PRO-806, respectively.
65,7 % oziroma 64,0 % bolnikov, ki so bili do konca vključeni v študiji PRO-805 oziroma PRO-806.
After insertion of the implants, the doctor will apply a sterile gauze with a pressure bandage to minimize bruising.
Ko bodo implantati vstavljeni, bo zdravnik namestil sterilno gazo s kompresijskim povojem, da bo zmanjšal nastajanje modric.
In case toxicity or overdose symptoms develop, the removal of the implants and transition to a medicinal product that allows dose adjustment are required.
Če se pojavijo simptomi toksičnosti ali prevelikega odmerjanja, je treba odstraniti implantate in preiti na zdravilo, ki omogoča prilagajanje odmerka.
When a hepatic event is suspected, liver function evaluation is required, including consideration whether to discontinue treatment with Sixmo.
Če sumite na jetrni dogodek, je treba oceniti delovanje jeter in razmisliti o prekinitvi zdravljenja z zdravljenje z zdravilom
Follow steps 15 and 16 for the removal of the remaining implants through the same incision.
Za odstranjevanje preostalih treh implantatov skozi isti rez glejte 15. in 16. korak.
The following equipment is needed for implant insertion under aseptic conditions:
Za vstavljanje implantata v aseptičnih pogojih je potrebna naslednja oprema:
In the analysis of the CDF (weeks 1 to 16), a statistically significant difference between treatments (p=0.0361) was seen, which was in favour of Sixmo.
Pri analizi kumulativne funkcije porazdelitve (primarni sočasno opazovani dogodek 1) je bila opažena statistično pomembna razlika med zdravljenji (p< 0,0001), ki je bila v prid zdravilu Sixmo.
Skin and subcutaneous tissue disorders common hyperhidrosis uncommon cold sweat, dry skin, rash, skin lesion, ecchymosis*
Bolezni kože in podkožja pogosti hiperhidroza občasni mrzel znoj, suha koža, izpuščaj, kožne lezije,
• signs of intoxication or overdose appear (miosis, lip cyanosis, sedation, bradycardia,
• če se pojavijo znaki zastrupitve ali prevelikega odmerjanja (mioza, cianoza ustnic, sedacija, bradikardija, hipotenzija, depresija dihanja);
After removal of the implant, the doctor will apply a sterile gauze with a pressure bandage to minimize bruising.
Ko bodo implantati odstranjeni, bo zdravnik namestil sterilno gazo s kompresijskim povojem, da bo zmanjšal nastajanje modric.
Apply liquid adhesive to the skin margins and allow to dry before closing the incision with the thin adhesive strip around 6 mm wide (butterfly strip).
Na robove kože nanesite tekoče lepilo in pustite, da se posuši, preden rez zaprete s tankim lepilnim trakom širine pribl.
Apply a pressure bandage with sterile gauze to minimize bruising.
Namestite kompresijski povoj s sterilno gazo, da čim bolj zmanjšate modrice.
Equipment for subcutaneous insertion of Sixmo
Oprema za subkutano vstavljanje zdravila Sixmo
All patients receiving Sixmo should be monitored for conditions indicative of diversion, or progression of opioid dependence and addictive behaviours suggesting the need for more intensive and structured treatment for substance use.
Vse bolnike, ki uporabljajo zdravilo Sixmo, je treba spremljati glede znakov, ki kažejo na preusmerjanje uporabe ali poslabšanje odvisnosti od opioidov ter vedenja, ki kaže na zasvojenost,
• a history of connective tissue disease such as scleroderma • a history of recurrent methicillin-resistant Staphylococcus aureus infections (MRSA)
• ponavljajoče okužbe z bakterijo Staphylococcus aureus, odporno proti metilicinu (MRSA), v zdravstveni zgodovini.
In this double-blind and double-dummy study, patients maintained on doses of sublingual buprenorphine of 8 mg/day or less were transferred to 4 Sixmo implants (and daily sublingual placebo), or sublingual buprenorphine 8 mg/day or less (and 4 placebo implants).
razporedili v skupino s 4 implantati Sixmo (in dnevnim podjezičnim placebom) ali v skupino s podjezičnim buprenorfinom 8 mg/dan ali manj (in 4 implantati s placebom).
Implant kit: 4 Sixmo implants with 1 applicator
Komplet implantatov: 4 implantati Sixmo z 1 aplikatorjem 6.6 Posebni varnostni ukrepi za odstranjevanje
ITT=intent-to-treat, SL BPN = sublingual buprenorphine Buprenorphine was not included in urine toxicology assessments.
ITT = populacija z namenom zdravljenja (intent-to-treat), SL BPN = podjezični buprenorfin