natgillin/translations-raw huggingface dataset:
orBec is a medicine containing the active substance beclomethasone dipropionate.
Zdravilo orBec je zdravilo, ki vsebuje zdravilno učinkovino beklometazon dipropionat.
The effectiveness of orBec was studied in one main study, in which orBec was compared with placebo (a dummy treatment) in 129 patients with gastrointestinal graft-versus-host disease.
Učinkovitost zdravila orBec so preučevali v eni glavni študiji, v kateri so pri 129 bolnikih z gastrointestinalno boleznijo presadka proti gostitelju zdravilo orBec primerjali s placebom (zdravilom brez zdravilne učinkovine).
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of orBec had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
CHMP je v času umika menil, da koristi zdravila orBec niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
How is orBec expected to work?
Kako naj bi zdravilo orBec delovalo?
This may appear several days after birth.
To se lahko pojavi nekaj dni po rojstvu.
This must be for at least 30 days and to be decided by your doctor.
To mora trajati vsaj 30 dni in o tem odloči vaš zdravnik.
Patient characteristics in these studies are shown below.
Značilnosti bolnikov v teh študijah so prikazane spodaj.
Local representative contact
Kontakt lokalnega predstavnika
Patients over 65 years
Bolniki, stari več kot 65 let
• social support system
• sistem socialne podpore.
Patient name:
Ime bolnika:
Do not attempt to remove the implants by yourself as this could be very dangerous.
Implantatov ne poskušajte odstraniti sami, saj je to lahko zelo nevarno.
• The patient should be able to lie on their back.
• Bolnik mora biti sposoben ležati na hrbtu.
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1369/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1369/001
• stability of living environment
• stabilnost življenjskega okolja,
The experience of a second treatment cycle is limited.
Izkušnje z drugim ciklom zdravljenja so omejene.
Therefore, dosages must be limited and this combination must be avoided in cases where there is a risk of misuse.
Zato je treba odmerke omejiti in se izogniti tej kombinaciji v primerih, ko obstaja tveganje za zlorabo.
Important aspects to consider during treatment:
Pomembni dejavniki, ki jih je treba upoštevati med zdravljenjem:
Percentage of negative results
Odstotek negativnih rezultatov
Primary opioid of abuse, n (%)
Primarni zlorabljani opioid, n (%)
The nature of the syndrome may vary depending upon the mother's drug use history.
Narava tega sindroma se lahko razlikuje glede na materino zgodovino jemanja drog.
• general weakness and poor health, or you are elderly
• splošno šibkost ali slabo zdravje, ali če ste starejši,
• Always keep this card with you while on treatment.
• To kartico imejte v času zdravljenja vedno pri sebi.
The implant time was 24 weeks.
Čas implantacije je znašal 24 tednov.
Number (%) of broken implants
Število (%) zlomljenih implantatov
Treating doctor (name / contact information):
Lečeči zdravnik (ime/kontaktni podatki):
• Drowsiness may occur especially in the first week after insertion.
• Lahko se pojavi zaspanost, zlasti v prvem tednu po vstavitvi.
• participation in a structured activity/job
• sodelovanje pri strukturirani aktivnosti/delu,
Breakage rates decreased in studies using the current technique and training.
Število zlomov je bilo nižje v študijah, ki so uporabljale trenutno tehniko in usposabljanje.
• This medicine can cause dependence, but at a lower level than other substances such as morphine.
• To zdravilo lahko povzroči odvisnost, toda v manjši meri kot druge snovi, na primer morfin.
Acute alcoholism or delirium tremens
Akutni alkoholizem ali delirium tremens
Frequency categories are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Overdose symptoms include:
Simptomi prevelikega odmerjanja vključujejo:
This endpoint was considered to be of clinical relevance in the targeted indication.
Ta opazovani dogodek je veljal za klinično relevantnega pri ciljni indikaciji.
• adequate lighting, such as headlamp
• ustrezna osvetlitev, kot je čelna luč,
Sixmo with food, drink and alcohol
Zdravilo Sixmo skupaj s hrano, pijačo in alkoholom
Weeks 1 to 16
1. do 16. teden
It is used to treat opioid dependence in adults who are also receiving medical, social and psychological support.
Uporablja se za zdravljenje odvisnosti od opiodiov pri odraslih, ki so deležni tudi zdravstvene, socialne in psihološke podpore.
The syndrome is generally delayed for several hours to several days after birth.
Sindrom se običajno pojavi nekaj ur ali nekaj dni po rojstvu.
• Present this card to your doctor, dentist or surgeon before any medical treatment or surgery.
• To kartico pokažite zdravniku, zobozdravniku ali kirurgu pred vsakim zdravljenjem ali kirurškim posegom.
Buprenorphine is approximately 96% protein bound, primarily to alpha and beta globulin.
Buprenorfin je približno 96-odstotno vezan na beljakovine, predvsem na alfa in beta globulin.
• period without episodes of hospitalisations (addiction or mental health issues), emergency room visits, or crisis interventions
• obdobje brez epizod hospitalizacije (težav z odvisnostjo ali duševnim zdravjem), nujne zdravniške pomoči ali kriznih posredovanj,
The syndrome may be milder and more protracted than that from short acting full μ-opioid agonists.
Sindrom je lahko blažji in dolgotrajnejši kot pri kratko delujočih polnih μ-opioidnih agonistih.
4.5 Interaction with other medicinal products and other forms of interaction Buprenorphine should not be administered together with:
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Buprenorfina se ne sme uporabljati skupaj z:
In some cases, the dose delivered by the implants might be more than the one you need.
V nekaterih primerih je lahko odmerek, ki ga dovajajo implantati, lahko večji od potrebnega.
This product may cause dizziness, somnolence or sedation especially at the start of treatment.
To zdravilo lahko povzroči omotico, zaspanost ali sedacijo, zlasti na začetku zdravljenja.
The majority of patients (around 80%) in both studies were adequately treated with 4 implants; around 20% of patients required a dose increase with a fifth implant.
Večina bolnikov (približno 80 %) v obeh študijah je bila ustrezno zdravljena s 4 implantati; približno 20 % bolnikov je potrebovalo povečanje odmerka s petim implantatom.
Step 12: Complete the Patient Alert Card and give it to the patient to keep.
12. korak: Izpolnite opozorilno kartico za bolnika in jo izročite bolniku, ki naj jo shrani.
Of these 309 patients, 107 patients were treated for an additional 6 months in extension studies (i.e. for 2 implant cycles).
Od teh 309 bolnikov so 107 bolnikov zdravili še dodatnih 6 mesecev v okviru nadaljevalnih študij (tj. s cikla implantatov).
Despite the use of an open-label comparator arm, this endpoint is considered robust, as it is based on urine toxicology.
Kljub uporabi odprtega primerjalnega kraka ta opazovani dogodek velja za robustnega, saj temelji na toksikoloških ocena urina.
You may fell dizzy, drowsy and less alert.
Lahko boste omotični, zaspani in manj pozorni.
• reduced consciousness
• zmanjšana zavest,
Side effects can occur with the following frequencies: Common, may affect up to 1 in 10 people
Neželeni učinki se lahko pojavijo z naslednjo pogostnostjo: Pogosti, pojavijo se lahko pri največ 1 od 10 bolnikov
Prescription opioids * For 1 patient (0.8%) primary opioid of abuse was “other”.
Opioidi na recept * Za 1 bolnika (0,8 %) je bil primarni zlorabljani opioid naveden kot „drugi“.
• head injury or other circumstances where the pressure in the head may be increased
• poškodbo glave ali druge okoliščine, kjer lahko pride do povišanega tlaka v glavi,
Key instruction for proper insertion
Glavna navodila za pravilno vstavitev
Number (%) of patients with broken implant(s) N=number of patients with data available.
Število (%) bolnikov z zlomljenim/zlomljenimi implantatom/implantati n = število bolnikov, pri katerih so bili podatki na voljo.
The implants should only be removed by a doctor who is familiar with the procedure.
Implantate sme odstraniti le zdravnik, ki je seznanjen s postopkom.
Instead, patients who feel the need for supplemental dosing should be seen and evaluated promptly.
Namesto tega je treba bolnike, ki se jim zdi, da potrebujejo dodatne odmerke, pregledati in ustrezno oceniti.
• are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6)
• če ste alergični na buprenorfin ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
• Alcoholic drinks or medicines containing alcohol, as alcohol increases the sedative effect of buprenorphine.
• alkoholnimi pijačami ali zdravili, ki vsebujejo alkohol, saj alkohol poveča sedacijski učinek buprenorfina.
In the worst case, it can result in breathing stopping, heart failure and death.
V najslabšem primeru se dihanje lahko ustavi, lahko pride do odpovedi srca in smrti.
The basis for successful use and subsequent removal of Sixmo is a correct and carefully performed subcutaneous insertion of the implants in accordance with the instructions.
Osnova za uspešno uporabo in zatem odstraniev zdravila Sixmo je pravilna in skrbno izvedena subkutana vstavitev implantatov v skladu z navodili.
If you cannot feel each of the four implants, or doubt their presence, use other methods to confirm the presence of the implant.
Če ne zatipate vsakega od štirih implantatov ali dvomite o njihovi prisotnosti, uporabite kakšno drugo metodo za preverjanje prisotnosti implantata.
Inform your doctor immediately if you think you have an infection at the implant site or if the implant starts to come out.
Zdravnika takoj obvestite, če menite, da imate okužbo na mestu implantata ali če implantat začne izstopati.
PROCEDURAL INFORMATION Insertion date:
PODATKI O POSTOPKU Datum vstavitve:
Avoid grapefruit juice to prevent possible side effects.
Ne pijte soka grenivke, da preprečite morebitne neželene učinke.
No published information is available regarding a potential effect of buprenorphine on male and female fertility.
Na voljo ni novenih objavljenih informacij v zvezi z morebitnimi učinki buprenorfina na plodnost pri moških in ženskah.
This risk increases when additionally using alcohol or other substances.
To tveganje se še poveča ob sočasni uporabi alkohola ali drugih snovi.
Inform your doctor immediately if the above symptoms occur, or go to the nearest hospital and bring this leaflet and your Patient Alert Card with you.
Če se pojavijo ti simptomi, o tem takoj obvestite zdravnika ali pojdite v najbližjo bolnišnico in ta navodila ter opozorilno kartico za bolnika prinesite s seboj.
The doctor will monitor you until the implant is replaced to evaluate for withdrawal symptoms.
Zdravnik vas bo spremljal, dokler implantat ne bo zamenjan, da bo ocenjeval simptome odtegnitve.
1 single use applicator
1 aplikator za enkratno uporabo
The implant applicator (disposable) and its parts are shown in Figure 1.
Aplikator za implantate (za enkratno uporabo) in njegovi deli so prikazani na sliki 1.
Implants inserted more deeply than subcutaneous (deep insertion) may not be palpable and the localisation and/or removal may be difficult.
Implantatov, ki so vstavljeni globlje kot subkutano (globoka vstavitev) morda ne bo mogoče zatipati in bosta lokalizacija in/ali odstranitev otežena.
The removed implant contains a significant amount of residual buprenorphine.
Odstranjeni implantat vsebuje znatno količino preostalega buprenorfina.
These underlying factors including confirmation of viral hepatitis status must be taken into consideration before prescribing Sixmo and during treatment.
Te osnovne dejavnike, vključno s potrditvijo stanja virusnega hepatitisa, je treba upoštevati pred predpisovanjem zdravila Sixmo in med zdravljenjem.
The same technique is employed for the removal of protruding or partially expelled implants.
Enaka tehnika se uporablja za odstranjevanje ven štrlečih ali delno iztisnjenih implantatov.
When pregnant rats were exposed to buprenorphine through osmotic minipumps from gestation day 7 onwards, maternal food and water consumption was reduced on gestation days 7 to 20.
Ko so bile breje podgane preko osmotskih mini črpalk izpostavljene buprenorfinu od 7. dneva brejosti naprej, je bila pri samicah od 7. do 20. dneva brejosti poraba hrane in vode manjša.
Physicians should also be informed about risks and complications of this procedure (i.e. implant migration, protrusion, expulsion, and nerve damage).
Zdravnike je treba obvestiti tudi o tveganjih in zapletih tega postopka (tj. migracija, protruzija, ekspulzija implantata in poškodovanje živcev).
Step 14: Put on sterile gloves.
14. korak: Nadenite si sterilne rokavice.
• the patient experiences severe or intolerable side effects (including severe precipitated withdrawal);
• če se pri bolniku pojavijo hudi ali nevzdržni neželeni učinki (vključno s hudimi odtegnitvenimi simptomi);
Higher doses may be required for analgesic effect.
Za učinek analgezije bodo morda potrebni večji odmerki.
If you feel the need for additional buprenorphine doses, contact your doctor straight away.
Če menite, da potrebujete dodatne odmerke buprenorfina, se takoj posvetujte z zdravnikom.
Studies in animals, as well as clinical experience, have demonstrated that buprenorphine may produce dependence, but at a lower level than a full agonist, e.g. morphine.
Študije na živalih in klinične izkušnje so pokazale, da buprenorfin lahko povzroča odvisnost, vendar v manjši meri kot popolni agonist, npr. morfin.
This risk is increased with the concomitant abuse of buprenorphine and alcohol and other substances, especially benzodiazepines.
To tveganje se poveča s sočasno zlorabo buprenorfina in alkohola ter drugih snovi, zlasti benzodiazepinov.
In 3 patients treated in clinical studies, and in 1 patient treated during post-marketing, implants or fragments could not be located and were, therefore, not removed at the end of the treatment.
Pri 3 bolnikih v kliničnih študijah in pri 1 bolniku po začetku trženja zdravila ni bilo mogoče najti implantatov ali njegovih delcev in zato ob koncu zdravljenja niso bili odstranjeni.
• consistency in participation in recommended behavioural therapy/peer support programme
• stalno sodelovanje v priporočeni vedenjski terapiji/programih medsebojne podpore,
They are removed by the end of the sixth month.
Na koncu obdobja 6 mesecev se odstranijo.
Buprenorphine can influence the ability to drive and use machines and may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Buprenorfin lahko vpliva na sposobnost vožnje in upravljanja strojev ter lahko poslabša mentalne ali fizične sposobnosti, ki so potrebne za opravljanje potencialno nevarnih nalog, kot je vožnja avtomobila ali upravljanje strojev.
If localisation and a second removal attempt are not performed on the same day as the initial removal attempt, the wound should be closed with sutures in the interim.
Če lokalizacije in drugega poskusa odstranitve ne opravite isti dan kot prvi poskus odstranitve, je treba rano začasno zapreti s šivi.
Hepatitis and hepatic events
Hepatitis in jetrni dogodki
NAME OF THE MARKETING AUTHORISATION HOLDER L. Molteni & C. dei F.lli Alitti
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM L. Molteni & C. dei F.lli Alitti
Particularly, this occurs when additionally using alcohol, other opioids or certain medicines which calm, induce sleep or relax muscles.
To se zgodi predvsem pri sočasni uporabi alkohola, drugih opioidov ali določenih zdravil za pomiritev, uspaval ali zdravil, ki sproščajo mišice.
Maternal exposure to buprenorphine increased perinatal mortality and caused a delay in some development milestones in neonatal rats.
Izpostavljenost mater buprenorfinu je povečala perinatalno umrljivost in povzročila zakasnitve pri nekaterih razvojnih mejnikih novoskotenih podgan.
The recommended visit schedule for most patients is a frequency of no less than once-monthly for continued counselling and psychosocial support.
Priporočeni urnik kontrolnih pregledov je pri večini bolnikov vsak enkrat mesečno, da imajo stalno na voljo svetovanje in psihosocialno podporo.
• breathing difficulties, breathing slowly
• težave z dihanjem, počasno dihanje.
• The replacement implant(s) should be inserted in same arm either medially or laterally to in situ implants.
• Nadomestni(-e) implantat(-e) je treba vstaviti v isto roko medialno ali lateralno glede na implantate in situ.
Its activity in opioid maintenance treatment is attributed to its slowly reversible properties at the µ receptors which, over a prolonged period, minimises the need for use of other opioids.
Njegova aktivnost pri opioidnem vzdrževalnem zdravljenju se pripisuje njegovim počasi reverzibilnim lastnostim na μ-opioidnih receptorjih, ki lahko prek daljšega obdobja zmanjša potrebo po drugih opioidih.
• Substances like buprenorphine may cause pinpoint pupils, change consciousness or the way you feel pain.
• Snovi, kot je buprenorfin, lahko povzročijo zoženje zenic, spremembo zavesti ali načina, kako občutite bolečino.
In rare cases, implants or partial implants could not be localized and were, therefore, not removed (see section 4.2).
V redkih primerih implantatov ali delov implantatov ni mogoče lokalizirati in posledično tudi ne odstraniti (glejte poglavje 4.2).
• increased level of a liver enzyme, alanine aminotransferase, in blood tests
• povišane vrednosti jetrnih encimov, alanin-aminotransferaze, pri krvnih pregledih,
It consists of four implants individually packaged into laminated foil sachets and one individually packaged sterile disposable applicator.
Vsebuje štiri implantate, ki so posamično pakirani v laminiranih vrečicah iz folije, in en posamično pakiran sterilen aplikator za enkratno uporabo.
Treat these patients with a non-opioid analgesic whenever possible.
Kadar je mogoče, te bolnike zdravite z neopioidnimi analgetiki.
• The active substance is buprenorphine.
• Učinkovina je buprenorfin.
If liver problems are suspected your doctor will carry out tests to decide if treatment should be stopped.
Če sumite na težave z jetri, bo zdravnik opravil teste, da bo odločil, ali je treba zdravljenje prekiniti.
Almost all of the dose was accounted for in terms of buprenorphine, norbuprenorphine, and two unidentified buprenorphine metabolites.
Skoraj ves odmerek je bil zajet v obliki buprenorfina, norbuprenorfina in dveh neprepoznanih presnovkov buprenorfina.
If infected, it should be treated appropriately and be determined if remaining implants need to be removed.
Če je mesto okuženo, ga je treba ustrezno zdraviti in oceniti, ali je treba odstraniti preostale implantate.
The CDF results for co-primary endpoint 2 were fundamentally the same as for endpoint 1 (p < 0.0001).
Rezultati CDF za primarni sočasno opazovani dogodek 2 so bili v osnovi enaki kot za opazovani dogodek 1 (p < 0,0001).
• asthma or other breathing problems
• astmo ali druge težave z dihanjem,
In particular, patients may experience somnolence for up to one week after subcutaneous insertion; therefore, they should be cautioned about driving or operating hazardous machinery especially during this time period.
Bolniki lahko do en teden po subkutani vstavitvi občutijo zaspanost, zato jih je treba opozoriti o nevarnostih vožnje ali upravljanja strojev zlasti v tem obdobju.
• The safety concerns associated with SIXMO therapy (i.e. potential life-threatening interactions with other, concomitant therapies)
• zadržke glede varnosti zdravljenja z zdravilom Sixmo (tj. morebitne življenje ogrožujoče interakcije z drugimi sočasnimi zdravili).
Implants for repeat treatment should be inserted subcutaneously as soon as possible after removal of the previous implants, preferably on the same day.
Implantate za ponovljeno zdravljenje je treba vstaviti subkutano čim prej po odstranitvi prejšnjih implantatov, po možnosti še isti dan.
• cold sweat, dry skin
• mrzel pot, suha koža,
Step 11: Apply pressure to the incision site for approximately five minutes if necessary.
11. korak: Približno pet minut pritiskajte na mesto reza, če je to potrebno.
NOTE: Be sure to inject the local anaesthetic deep to the centre of the implants; this will effectively lift the implants toward the skin, facilitating removal of the implants.
OPOMBA: Lokalni anestetik je treba injicirati globoko v sredino implantatov; na ta način se bodo implantati učinkovito dvignili proti koži, kar olajša njihovo odstranjevanje.
Stop immediately once the proximal marking on the cannula has disappeared into the incision (Figures 7 and 8).
Takoj se ustavite, ko proksimalna oznaka na kanili izgine v rez (sliki 7 in 8).
• Substances like buprenorphine may cause a sudden drop in blood pressure, causing dizziness when getting up quickly.
• Snovi, kot je buprenorfin, lahko povzročijo nenaden padec krvnega tlaka, ki povzroči omotico, če hitro vstanete.
Your doctor will also give you a Patient Alert Card that provides the
Zdravnik vam bo izročil tudi opozorilno kartico za bolnika, na kateri so navedeni
• infection or any problems with wound healing
• okužba ali druge težave s celjenjem rane,
The insertion site should be examined one week following implant insertion and regularly thereafter for signs of infection or any problems with wound healing, including evidence of implant extrusion from the skin as well as misuse or abuse.
Mesto vstavitve je treba pregledati en teden po vstavitvi implantata in redno tudi kasneje, kjer je treba biti pozoren na znake okužbe ali kakršnih koli težav s celjenjem rane, vključno z znaki za ekstruzijo implantata iz kože ter znake nepravilne uporabe oziroma zlorabe.
Renal elimination may be prolonged since 30% of the administered dose is eliminated by the renal route.
Izločanje skozi ledvice se lahko podaljša, ker se 30 % danega odmerka izloči prek ledvic.
Implant site related adverse reactions with the current (and commercially used) insertion and removal techniques were reported in 25.9% and 14.1% of patients in the double-blind and extension studies, respectively.
O neželenih učinkih na mestu implantata po trenutni (in komercialno uporabljeni) tehniki vstavitve in odstranjevanja so poročali pri 25,9 % bolnikov v dvojno slepih in 14,1 % bolnikov v nadaljevalnih študijah.
The insertion and removal of Sixmo should take place in a setting that allows for insertion under aseptic conditions, where the patient is able to lie on their back.
Vstavljanje in odstranjevanje zdravila Sixmo mora potekati v okolju, ki omogoča vstavljanje v aseptičnih pogojih in kjer bolnik lahko leži na hrbtu.
• If the patient returns the expelled implant, it should be measured to ensure that the entire implant was expelled (26.5 mm in length).
• Če bolnik iztisnjeni implantat vrne, je treba implantat izmeriti za potrditev, da se je izločil celoten implantat (dolžine 26,5 mm).
The safety of Sixmo was evaluated in five Phase 3 studies (3 double-blind and placebo and/or activecontrolled studies, and two open-label extension studies).
Varnost zdravila Sixmo je bila ocenjena v petih študijah 3. faze (3 dvojno slepe, s placebom in/ali aktivno kontrolo nadzorovane študije, ter 2 odprti nadaljevalni študiji).
• Misuse and abuse: If buprenorphine is abused it can lead to overdose and death.
• Nepravilna uporaba oziroma zloraba: Če buprenorfin zlorabljate, lahko pride do prevelikega odmerjanja in smrti.
The remaining partial implant should be removed using the techniques described in section 4.2 under “Instructions for removal of Sixmo”.
Preostali delni implantat je treba odstraniti s tehnikami, ki so opisane v poglavju 4.2 pod naslovom „Navodila za odstranjevanje implantatov Sixmo“.