qanastek/EMEA-V3 huggingface dataset:
230 corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
244 jistgħu jwasslu għal din il- marda jinkludu t- tul tat- terapija antiretrovirali kombinata, użu ta ’ kortikosterojdi, konsum ta ’ l- alkoħol, immunosoppressjoni severa u indiċi ogħla tal- massa tal- ġisem fost oħrajn.
Use in children STOCRIN 600 mg film-coated tablets can be taken by children 3 years of age and older who are able to swallow the tablets (see How to take STOCRIN).
Użu fit- tfal Pilloli STOCRIN miksijin b’ rita ta ’ 600 mg jista ’ jittieħed minn tfal ta ’ 3 snin u ikbar li jistgħu jibilgħu il- pilloli (ara Kif tieħu STOCRIN.)
These are listed under Do not take STOCRIN, at the start of Section 2.
Dawn huma elencati taħt Tiħux STOCRIN, fil - bidu ta ’ Sezzjoni 2.
They include some common medicines and a herbal remedy (St.
Jinkludu mediċini comuni u rimedju erbali (St.
John’s wort) which can cause serious interactions.
John’ s wort) li jistgħu jikkawżaw interazzjonijiet serji.
As a result, the amounts of STOCRIN or other medicines in your blood may be affected.
B’ konsegwenza ta ’ hekk, l- ammonti ta ’ STOCRIN jew mediċini oħrajn fid- demm tiegħek jistgħu jiġu affettati.
protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, ritonavirboosted atazanavir, saquinavir or fosamprenavir/saquinavir.
jew fosamprenavir/ saquinavir imsaħħin b’ ritonavir.
-
STOCRIN jista ’ jnaqqas l- ammont ta ’ voriconazole fid- demm tiegħek u
Medicines used to treat convulsions/seizures (anticonvulsants): carbamazepine, phenytoin, phenobarbital.
Mediċini użati biex jikkuraw konvulżjonijiet/ attakki (antikonvulżjonijiet): carbamazepine, phenytoin, phenobarbital.
Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your dose of methadone.
245 Methadone, mediċina użata biex tikkura l- vizzju ta ’ opjati, minħabba li t- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża ta ’ methadone tiegħek.
231 Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline.
Sertraline, mediċina użata biex tikkura d- depressjoni, minħabba li t- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża ta ’ sertraline tiegħek.
Important information about some of the ingredients of STOCRIN This medicinal product contains 250 mg of lactose in each 600-mg daily dose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ STOCRIN Dan il- prodott mediċinali fih 250 mg ta ’ lactose f’ kull doża ta ’ kuljum ta ’ 600 mg.
It is recommended that the tablet be swallowed whole with water.
Huwa rakkomandat li l- pillola tinbela ’ sħiħa ma ’ l- ilma.
• STOCRIN is for oral use.
246 • STOCRIN huwa għal użu orali.
STOCRIN Dose (mg)∗ 200 2 50 300 350 400
STOCRIN Doża (mg) 200 250 300 350 400
∗ STOCRIN 50 mg, 200 mg and 600 mg film-coated tablets are available.
* Hemm pilloli miksija b’ rita STOCRIN ta ’ 50 mg, 200 mg u 600 mg.
If you do miss a dose, take the next dose as soon as possible, but do not take a double dose to make up for a forgotten dose.
Jekk taqbeż doża, ħu d- doża li jmiss kemm jista ’ jkun malajr, tiħux doża doppja biex tpatti għad- doża li nsejt tieħu.
You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with STOCRIN.
247 Għandek tikkonsulta lit- tabib jekk għandek raxx, billi xi wħud jistgħu ikunu serji; madankollu, il- biċċa l- kbira mill- każijiet ta ’ raxx jgħibu mingħajr bidla fil- kura bi STOCRIN.
If any of the side effects get serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
248 Jekk xi effetti sekondarji jsiru serji, jew jekk tinduna b ’ xi effetti oħrajn li mhux imniżżlin f’ dan il- fuljett, jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek.
Do not use STOCRIN after the expiry date which is stated on the bottle or blister and on the carton after EXP.
Tużax STOCRIN wara d- data ta ’ l- iskadenza li tinstab fuq il- flixkun jew folja u l- kartuna wara JIS.
234 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
• Each STOCRIN film-coated tablet contains 600 mg of the active substance efavirenz. • The other ingredients of the tablet core are: croscarmellose sodium, microcrystalline cellulose, sodium laurilsulfate, hydroxypropylcellulose, lactose monohydrate and magnesium stearate. • The film coating contains: hypromellose (E464), titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), and carnauba wax.
• Kull pillola STOCRIN miksija b’ rita fiha 600 mg tas- sostanza attiva efavirenz. • L- ingredjenti l- oħra fil- qalba tal- pillola huma: croscarmellose sodium, microcrystalline cellulose, sodium laurilsulfate, hydroxypropylcellulose, lactose monohydrate, u magnesium stearate. • Ir- rita tal- kisi fiha: hypromellose (E464), titanium dioxide (E171), macrogol 400, iron oxide isfar (E172), u xama ’ tal- carnauba.
STOCRIN 600 mg film-coated tablets are supplied in bottles of 30 tablets and in packs containing 30 x 1 tablets in aluminium perforated unit dose blisters.
Il- pilloli STOCRIN miksija b’ rita tat- 600 mg jiġu fi fliexken ta ’ 30 pillola u f’ pakketti li fihom 30 x 1 pillola f’ folji ta ’ l- aluminju mtaqqab għal dożi waħedhom.
Česká republika Merck Sharp & Dohme IDEA, Inc., org. sl.
249 Malta Česká republika A. M. Mangion Ltd.
Tel.: +420 233 010 111 msd_cr@merck.com
Merck Sharp & Dohme IDEA, Inc., org. sl Tel: +356 2397 6000 Tel.: +420 233 010 111 medinfo_ mt@ merck. com msd_ cr@ merck. com
Κύπρος Merck Sharp & Dohme (Middle East) Limited.
250 Sverige Κύπρος Merck Sharp & Dohme (Sweden) AB Merck Sharp & Dohme (Middle East) Limited.
236 This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f ’
237 PACKAGE LEAFLET:
251 FULJETT TA ’ TAGĦRIF:
How to take STOCRIN 4.
Kif għandek tieħu STOCRIN 4.
Taking these medicines with STOCRIN could create the potential for serious and/or life-threatening side-effects or stop STOCRIN from working properly. • STOCRIN from working properly.
Jekk tieħu dawn il - mediċini ma ’ STOCRIN jista ’ jkollok effetti mhux mixtieqa serji u/ jew ta ’ theddida għall- ħajja jew tista ’ timpedixxi lil STOCRIN milli jaħdem b’ mod xieraq.
238 Take special care with STOCRIN • STOCRIN must be taken with other medicines that act against the HIV virus.
252 • STOCRIN irid jittieħed ma ’ mediċini oħra li jaħdmu kontra l- virus ta ’ l- HIV.
239 corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
253 jistgħu jwasslu għal din il- marda jinkludu t- tul tat- terapija antiretrovirali kombinata, użu ta ’ kortikosterojdi, konsum ta ’ l- alkoħol, immunosoppressjoni severa u indiċi ogħla tal- massa tal- ġisem fost oħrajn.
Use in children STOCRIN 50 mg film-coated tablets can be taken by children 3 years of age and older who are able to swallow the tablets (see How to take STOCRIN).
Użu fit- tfal Pilloli STOCRIN miksijin b’ rita ta ’ 50 mg jista ’ jittieħed minn tfal ta ’ 3 snin u ikbar li jistgħu jibilgħu il pillolo ibsin (ara Kif tieħu STOCRIN.)
protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, ritonavir boosted atazanavir, saquinavir or fosamprenavir/saquinavir.
jew fosamprenavir/ saquinavir imsaħħin b’ ritonavir.
STOCRIN can reduce the amount of statins in your blood.
STOCRIN jista ’ jnaqqas l- ammont ta ’ statini fid- demm
240 Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline.
Sertraline, mediċina użata biex tikkura d- depressjoni, minħabba li t- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża ta ’ sertraline tiegħek.
3.
255 3.
STOCRIN Dose (mg)∗ 200 2 50 300 350 400
STOCRIN Doża (mg) * 200 250 300 350 400
∗ STOCRIN 50 mg, 200 mg and 600 mg film-coated tablets are available.
∗ Hemm pilloli miksija b’ rita STOCRIN ta ’ 50 mg, 200 mg u 600 mg.
You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with STOCRIN.
256 Għandek tikkonsulta lit- tabib jekk għandek raxx, billi xi wħud jistgħu ikunu serji; madankollu, il- biċċa l- kbira mill- każijiet ta ’ raxx jgħibu mingħajr bidla fil- kura bi STOCRIN.
Some patients have more serious symptoms that may affect mood or the
Xi pazjenti jkollhom sintomi iktar serji li jistgħu jaffettwaw il- burdata u l- ħila li taħseb b’ mod ċar.
• Each STOCRIN film-coated tablet contains 50 mg of the active substance efavirenz. • The other ingredients of the tablet core are: croscarmellose sodium, microcrystalline cellulose, sodium laurilsulfate, hydroxypropylcellulose, lactose monohydrate and magnesium stearate. • The film coating contains: hypromellose (E464), titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), and carnauba wax.
• Kull pillola STOCRIN miksija b’ rita fiha 50 mg tas- sostanza attiva efavirenz. • L- ingredjenti l- oħra fil- qalba tal- pillola huma: croscarmellose sodium, microcrystalline cellulose, sodium laurilsulfate, hydroxypropylcellulose, lactose monohydrate, u magnesium stearate. • Ir- rita tal- kisi fiha: hypromellose (E464), titanium dioxide (E171), macrogol 400, iron oxide isfar (E172), u xama ’ tal- carnauba.
STOCRIN 50 mg film-coated tablets are supplied in bottles of 30 tablets.
Il- pilloli STOCRIN miksija b’ rita tat- 50 mg jiġu fi fliexken ta ’ 30 pillola.
Nederland Merck Sharp & Dohme B.V.
258 Nederland Danmark Merck Sharp & Dohme B. V.
Simí: +354 540 8000 ISmail@merck.com
Ísland Icepharma Simí: +354 540 8000 ISmail@ merck. com
United Kingdom Bristol-Myers Squibb Pharmaceuticals Ltd.
259 United Kingdom Latvija Bristol- Myers Squibb Pharmaceuticals Ltd.
245 This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f ’
246 PACKAGE LEAFLET:
260 FULJETT TA ’ TAGĦRIF:
STOCRIN 200 mg film-coated tablets efavirenz
STOCRIN 200 mg pilloli miksija b’ rita efavirenz
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you.Do not pass it on to others.
Jista ’ jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek. • Din il- mediċina ġiet mogħtija lilek.
2.
X’ inhu STOCRIN u għalxiex jintuża 2.
WHAT STOCRIN IS AND WHAT IT IS USED FOR?
X’ INHU STOCRIN U GĦALXIEX JINTUŻA
247 Take special care with STOCRIN • STOCRIN must be taken with other medicines that act against the HIV virus.
261 • STOCRIN irid jittieħed ma ’ mediċini oħra li jaħdmu kontra l- virus ta ’ l- HIV.
248 corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
262 jistgħu jwasslu għal din il- marda jinkludu t- tul tat- terapija antiretrovirali kombinata, użu ta ’ kortikosterojdi, konsum ta ’ l- alkoħol, immunosoppressjoni severa u indiċi ogħla tal- massa tal- ġisem fost oħrajn.
Use in children STOCRIN 200 mg film-coated tablets can be taken by children 3 years of age and older who are able to swallow the tablets (see How to take STOCRIN).
Użu fit- tfal Kapsuli ibsin STOCRIN ta ’ 50 mg jista ’ jittieħed minn tfal ta ’ 3 snin u ikbar li jistgħu jibilgħu il - kapsuli ibsin (ara Kif tieħu STOCRIN.)
249 Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline.
Sertraline, mediċina użata biex tikkura d- depressjoni, minħabba li t- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża ta ’ sertraline tiegħek.
3.
264 3.
∗ STOCRIN 50 mg, 200 mg and 600 mg film-coated tablets are available.
∗ Hemm pilloli miksija b’ rita STOCRIN ta ’ 50 mg, 200 mg u 600 mg film- coated tablets.
The most notable unwanted effects reported with STOCRIN in combination with other anti-HIV medicines are skin rash and nervous system symptoms.
265 L- iktar reazzjonijiet mhux mixtieqa notabbli marbuta ma ’ STOCRIN meta jingħata flimkien ma ’ mediċini oħra ta ’ kontra l- HIV u li ġew irrapurati jinkludu raxx u sintomi marbuta mas- sistema nervuża.
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, increased fat levels in the blood (hyperlipaemia) and resistance to insulin.
266 It- terapija antiretrovirali kombinata tista ’ tikkawża wkoll livelli ogħla ta ’ lactic acid u zokkor fil- demm, żieda fl- ammont ta ’ xaħam fid- demm (iperlipemija) u reżistenza għall- insulina.
252 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
• Each STOCRIN film-coated tablet contains 200 mg of the active substance efavirenz. • The other ingredients of the tablet core are: croscarmellose sodium, microcrystalline cellulose, sodium laurilsulfate, hydroxypropylcellulose, lactose monohydrate and magnesium stearate. • The film coating contains: hypromellose (E464), titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), and carnauba wax.
• Kull pillola STOCRIN miksija b’ rita fiha 200 mg tas- sostanza attiva efavirenz. • L- ingredjenti l- oħra fil- qalba tal- pillola huma: croscarmellose sodium, microcrystalline cellulose, sodium laurilsulfate, hydroxypropylcellulose, lactose monohydrate, u magnesium stearate. • Ir- rita tal- kisi fiha: hypromellose (E464), titanium dioxide (E171), macrogol 400, iron oxide isfar (E172), u xama ’ tal- carnauba.
STOCRIN 200 mg film-coated tablets are supplied in bottles of 90.
Il- pilloli STOCRIN miksija b’ rita tat- 200 mg jiġu fi fliexken ta ’ 90 pillola.
Česká republika Merck Sharp & Dohme IDEA, Inc., org. sl.
267 info- msdbg@ merck. com
253 Eesti Österreich Merck Sharp & Dohme OÜ Tel.: +372 6139 750 msdeesti@merck.com
Österreich Eesti Merck Sharp & Dohme GmbH.
Κύπρος Merck Sharp & Dohme (Middle East) Limited.
268 Sverige Κύπρος Merck Sharp & Dohme (Sweden) AB Merck Sharp & Dohme (Middle East) Limited.
254 This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f ’
255 ANNEX IV
269 ANNESS IV
GROUNDS FOR ONE ADDITIONAL RENEWAL
RAĠUNIJIET GĦAL TIĠDID ADDIZZJONALI WIEĦED
256 GROUNDS FOR ONE ADDITIONAL RENEWAL
270 RAĠUNIJIET GĦAL TIĠDID ADDIZZJONALI WIEĦED
Based on the review of the available information, the CHMP was of the opinion that the quality, the safety and the efficacy of this medicinal product continues to be adequately and sufficiently demonstrated and therefore considered that the benefit/risk balance of Stocrin remains favourable.
Fuq il- bażi tal- istudju tal- informazzjoni disponibbli, is- CHMP kien tal- opinjoni li l- kwalità, is- sigurtà u l- effikaċja ta ’ dan il- prodott mediċinali jibqgħu jintwerew b’ mod adegwat u suffiċjenti u għalhekk qies li l- bilanċ benefiċċju/ riskju ta ’ Stocrin jibqa ’ wieħed favorevoli.
However specific safety issues related to pharmacovigilance remain, which warrant a close monitoring.
Madankollu, jibqgħu kwistjonijiet speċifiċi tas- sigurtà relatati mal- farmakoviġilanza, li jeħtieġu monitoraġġ mill- qrib.
Overall, the number of spontaneous reports on hepatic toxicity and acute or sub-acute chronic hepatitis potentially serious and fatal presented in subjects without other known risk factors (hepatitis B/C co- infection) is a matter of concern in particular in view of the evolving therapeutic management of HIV infected patients.
B’ mod ġenerali, in- numru ta ’ rapporti spontanji dwar it- tossiċità tal- fwied u l- epatite kronika akuta u sub- akuta potenzjalment serji u fatali ppreżentati f’ suġġetti mingħajr fatturi ta ’ riskju magħrufin oħrajn (ko- infezzjoni bl- epatite B/ C) hija kwistjoni ta ’ tħassib b’ mod partikolari minħabba l- ġestjoni terapewtika li qiegħda tevolvi ta ’ pazjenti infettati bl- HIV.
As newer therapeutic options for the treatment of HIV infection become available, the benefit/risk balance should be continuously reassessed in light of the introduction of these new options into treatment regimens.
Filwaqt li għażliet terapewtiċi ġodda għall - kura tal- infezzjoni bl- HIV qiegħdin isiru disponibbli, il- bilanċ benefiċċju/ riskju għandu jiġi vvalutat mill- ġdid il- ħin kollu fid- dawl tal- introduzzjoni ta ’ dawn l- għażliet ġodda f’ reġimens ta ’ trattament.
Based on these issues, the CHMP is of the opinion that one additional five-year renewal on the basis of pharmacovigilance grounds is required.
Fuq il- bażi ta ’ dawn il- kwistjonijiet, is- CHMP huwa tal- opinjoni li huwa meħtieġ tiġdid addizzjonali wieħed ta ’ ħames snin fuq il- bażi ta ’ raġunijiet ta ’ farmakoviġilanza.
The MAH should continue to submit yearly PSURs, until otherwise specified by the CHMP.
Il- MAH għandu jkompli jissottometti PSURs kull sena, sakemm ma jkunx speċifikat mod ieħor mis- CHMP.
257
271
Suboxone 2 mg/ 0.5 mg sublingual tablets
Suboxone 2 mg/ 0. 5 mg pilloli għal taħt l- ilsien
Each tablet contains 2 mg buprenorphine (as buprenorphine hydrochloride) and 0.5 mg naloxone (as naloxone hydrochloride dihydrate).
Kull pillola fiha 2 mg buprenorphine (bħala buprenorphine hydrochloride) u 0. 5 mg naloxone (bħala naloxone hydrochloride dihydrate).
Excipients: lactose 42 mg
Sustanza mhux attiva: lactose 42 mg
Sublingual tablet
Pillola għal taħt l- ilsien
White hexagonal biconvex tablets, embossed with a sword logo on one side and “ N2” on the reverse side.
Pilloli konvessi miż- żewġ naħat, eżagonali bojod, imnaqqxin b’ logo ta ’ xabla fuq naħa u “ N2 ” fuq in - naħa l- oħra.
Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment.
Trattament ta ’ sostituzzjoni għad- dipendenza fuq drogi opjojd, fil- qafas ta ’ kura medika, soċjali u psikoloġika.
The intention of the naloxone component is to deter intravenous misuse.
L- iskop tal- komponent naloxone huwa biex jiskuraġġixxi l- użu ħażin minn ġol- vini.
Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.
It- trattament huwa għall- adulti u adolexxenti ta’ eta ’ ’ l fuq minn 15- il sena li jkunu qablu li għandhom jingħataw kura għall- vizzju.
Treatment must be under the supervision of a physician experienced in the management of opiate dependence/ addiction.
It- trattament għandu jsir taħt superviżjoni ta ’ tabib bl- esperjenza fl- immaniġġar tad - dipendenza/ vizzju ta ’ opjejt.
Each Suboxone sublingual tablet contains buprenorphine and naloxone.
Kull pillola għal taħt l- ilsien ta ’ Suboxone jkun fiha buprenorphine u naloxone.
Suboxone containing 2 mg buprenorphine and 0.5 mg naloxone is referred to as the "2 mg" tablets.
Suboxone li jkun fih 2 mg buprenorphine u 0. 5 mg naloxone jissejħu pilloli taż - “ 2 mg ”.
Physicians must warn patients that the sublingual route is the only effective and safe route of administration for this medicinal product (see section 4.4).
It- tobba għandhom iwissu lill- pazjenti li l- mezz ta ’ taħt l- ilsien huwa l- uniku mezz effettiv u sigur għall- għotja ta ’ dan il- prodott mediċinali (ara sezzjoni 4. 4).
Suboxone sublingual tablets are to be placed under the tongue until dissolved, which usually requires 5 to 10 minutes.
Il- pilloli għal taħt l- ilsien ta ’ Suboxone għandhom jitpoġġew taħt l- ilsien sakemm jinħallu, li normalment ikollhom bżonn 5 sa 10 minuti.
The dose is made up from Suboxone 2 mg/ 0.5 mg and Suboxone 8 mg/ 2 mg sublingual tablets, which may be taken all at the same time or in two divided portions; the second portion to be taken directly after the first portion has dissolved.
Id - doża hija magħmula minn Suboxone 2 mg/ 0. 5 mg u Suboxone 8 mg/ 2 mg pilloli għal taħt l- ilsien, li jistgħu jittieħdu kollha f’ daqqa jew maqsuma f’ żewġ partijiet, bit- tieni parti li għandha tittieħed eżattament wara li tkun inħallet l- ewwel parti.
Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing therapy.
Huwa rrikkmandat li jsiru testijiet tal- funzjoni tal- fwied mal- linja bażi u dokumentazzjoni ta ’ l- istat ta ’ l- epatite virali qabel ma tibda t- terapija.
Patients who are positive for viral hepatitis, on concomitant medicinal products (see section 4.5) and/ or have existing liver dysfunction are at risk of accelerated liver injury.
Pazjenti li huma pożittivi għall- epatite virali, li qed jieħdu prodotti mediċinali (ara sezzjoni 4. 5) u/ jew għandhom funzjoni ħażina tal- fwied għandhom riskju akbar li l- ħsara fil- fwied isseħħ aktar mgħaġġla.
Regular monitoring of liver function is recommended (see section 4.4).
Huwa rrikkmandat li jsir monitoraġġ regolari tal - funzjoni tal- fwied (ara sezzjoni 4. 4).
2 Induction:
2 Induzzjoni:
Prior to treatment induction, consideration should be given to the type of opioid dependence (i. e. long- or short-acting opioid), the time since last opioid use and the degree of opioid dependence.
Qabel l- induzzjoni għat- trattement, għandu jitqies it- tip ta ’ dipendenza opjojd (i. e. hux opjojd li jaħdem fit- tul jew fil- qosor), iż- żmien mill- aħħar użu ta ’ opjojd u l- grad ta ’ dipendenza għall- opjojd.
To avoid precipitating withdrawal, induction with Suboxone or buprenorphine only tablets should be undertaken when objective and clear signs of withdrawal are evident.
Biex ikun evitat li jiġu preċipitati l- effetti tal- waqfien tal- opjojd, induzzjoni b’ pilloli ta ’ Suboxone jew buprenorphine waħidhom għandha ssir meta l- għan u s- sinjali ċari tal- waqfien ikunu evidenti.
Initiation therapy:
Terapija tal- bidu:
The recommended starting dose is one to two tablets of Suboxone 2 mg/ 0.5 mg sublingual tablets.
Id- doża rrikkmandata tal- bidu hija pillola waħda jew żewġ pilloli għal taħt l- ilsien ta ’ Suboxone 2 mg/ 0. 5 mg.
An additional one to two tablets of the Suboxone 2 mg/ 0.5 mg may be administered on day one depending on the individual patient’ s requirement.
Jistgħu jingħataw pillola jew żewġ pilloli oħra ta ’ Suboxone 2 mg/ 0. 5 mg fl- ewwel jum skond il- ħtiġijiet tal- pazjent individwali.
Opioid-dependent drug addicts who have not undergone withdrawal:
Pazjenti li jkollhom il- vizzju tad- dipendenza fuq drogi opjojd li jkunu għadhom ma waqfux:
When treatment starts, the first dose of Suboxone should be taken when signs of withdrawal appear, but not less than 6 hours after the patient last used opioids (eg. heroin; short acting opioids).
Meta jibda t- trattament, l- ewwel doża ta ’ Suboxone għandha tittieħed meta jidhru l- ewwel sinjali tat - twaqqif, iżda mhux anqas minn 6 sigħat wara li l- pazjent ikun uża l- opjojds (eż heroin, opjojds li jaħdmu fil- qosor).
Patients receiving methadone:
Pazjenti li jkunu qed jirċievu methadone:
Before beginning Suboxone therapy, the dose of methadone must be reduced to a maximum of 30 mg/ day.
Qabel tibda t- terapija b’ Suboxone, id- doża ta ’ methadone għandha tiġi mnaqqsa għal massimu ta ’ 30 mg/ jum.
The first dose of Suboxone should be taken when signs of withdrawal appear, but not less than 24 hours after the patient last used methadone.
L- ewwel doża ta ’ Suboxone għandha tittieħed meta s- sinjali tat- twaqqif jidhru, iżda mhux anqas minn 24 siegħa minn meta l- pazjent ikun uża methadone.
Buprenorphine may precipitate symptoms of withdrawal in patients dependent upon methadone.
Buprenorphine jista ’ jikkawża s- sintomi tat- twaqqif f’ pazjenti li jkunu dipendenti fuq methadone.
Dosage adjustment and maintenance:
Aġġustar tad- doża u manteniment:
The dose of Suboxone should be increased progressively according to the clinical effect of the individual patient and should not exceed a maximum single daily dose of 24 mg.
Id- doża ta ’ Suboxone għandha tiżdied b’ mod progressiv skond l - effett kliniku tal- pazjent individwali u m’ għandux jaqbeż id- doża massima ta ’ 24 mg kuljum mogħtija bħala doża waħda.
The dosage is titrated according to reassessment of the clinical and psychological status of the patient and should be made in steps of 2-8 mg.
Id- dużaġġ għandu jiżdied bil- mod skond l- evalwar mill- ġdid ta ’ l- istat kliniku u psikoloġiku tal- pazjent u għandu jsir f’ ammonti ta ’ 2- 8 mg.
During the initiation of treatment, daily dispensing of buprenorphine is recommended.
Meta jkun qed jinbeda t- trattament, huwa rrikkmandat li l- pazjent jingħata buprenorphine ta ’ kuljum.
After stabilisation, a reliable patient may be given a supply of Suboxone sufficient for several days of treatment.
Wara li jkun qagħad, pazjent ta ’ min jafdaħ jista ’ jingħata skorta ta ’ Suboxone li tkun isservih għal bosta ġranet ta ’ trattament.
It is recommended that the amount of Suboxone be limited to 7 days or according to local requirements.
Huwa rrikkmandat li l- ammont ta ’ Suboxone ikun limitat għal 7 ijiem jew skond il- ħtiġijiet lokali.
Less than daily dosing:
Anqas minn dużaġġ kuljum:
After a satisfactory stabilisation has been achieved the frequency of Suboxone dosing may be decreased to dosing every other day at twice the individually titrated daily dose.
Wara li l- pazjent ikun ġie stabbiliżżat b’ mod sodisfaċenti, il- frekwenza tad- dużaġġi ta ’ Suboxone tista ’ titnaqqas għal dużaġġi li jingħataw darba kull jumejn b’ doża li tkun darbtejn daqs d- doża ta ’ kuljum li tkun ġiet ikkalkulata bil- mod il- mod għall- individwu.
For example, a patient stabilised to receive a daily dose of 8 mg may be given 16 mg on alternate days, with no dose on the intervening days.
Per eżempju, pazjent li jkun stabbilit fuq doża ta ’ 8 mg kuljum jista ’ jingħata 16 mg kull jumejn, mingħajr ma jieħu doża fil- jiem ta ’ bejniethom.
However, the dose given on any one day should not exceed 24 mg.
Madankollu, id- doża li tingħata f’ kwalunkwe jum m’ għandhiex taqbeż l - 24 mg.
In some patients, after a satisfactory stabilisation has been achieved, the frequency of Suboxone dosing may be decreased to 3 times a week (for example on Monday, Wednesday and Friday).
F’ xi pazjenti, wara li jkunu kisbu qagħda sodisfaċenti, il- frekwenza tad- dożi ta ’ Suboxone tista ’ titnaqqas għal 3 darbiet fil- ġimgħa (eż. it- Tnejn, L- Erba ’ u l- Ġimgħa).
The dose on Monday and Wednesday should be twice the individually titrated daily dose, and the dose on Friday should be three times the individually titrated daily dose, with no dose on the intervening days.
Id- doża ta ’ nhar ta ’ Tnejn u nhar t’ Erba ’ għandha tkun id- doppju tad- doża ta ’ kuljum li tkun ġiet ikkalkulata bil- mod il- mod għall- individwu, u d- doża ta ’ nhar il- Ġimgħa għandha tkun tlett darbiet id- doża ta ’ kuljum li tkun ġiet ikkalkulata bil- mod il- mod għall- individwu, mingħajr ma jingħataw dożi fil- ġranet ta ’ bejniethom.
However, the dose given on any one day should not exceed 24 mg.
Madankollu d- doża li tingħata f’ kwalunkwe jum m’ għandhiex taqbeż l- 24 mg.
Patients requiring a titrated daily dose > 8 mg/ day may not find this regimen adequate.
Pazjenti li jeħtieġu doża li tkun ġiet miżjuda għal > 8 mg/ jum jistgħu ma jsibux dan il- kors xieraq.
Dosage reduction and termination of treatment:
Tnaqqis fid- dużaġġ u twaqqif tat- trattament:
After a satisfactory stabilisation has been achieved, if the patient agrees, the dosage may be reduced gradually to a lower maintenance dose; in some favourable cases, treatment may be discontinued.
Wara li jkun qagħad b’ mod sodisfaċenti, jekk il- pazjenti ikun jaqbel, id- dużaġġ jista ’ jiġi mnaqqas bil- mod għal doża ta ’ manteniment aktar baxxa; f’ xi każijiet fejn ikun xieraq, it- trattament jista ’ jitwaqqaf.
The availability of the sublingual tablet in doses of 2 mg and 8 mg allows for a downward titration of dosage.
Il- fatt li l- pilloli għal taħt l- ilsien jiġu f’ dożi ta ’ 2 mg u 8 mg jippermetti li d- dużaġġ jitbaxxa bil- mod.
For patients who may require a lower buprenorphine dose, buprenorphine 0.4 mg sublingual tablets may be used.
Għal pazjenti li jkollhom bżonn doża ta ’ buprenorphine aktar baxxa, pilloli għal taħt l- ilsien ta ’ 0. 4 mg buprenorphine jistgħu jintużaw.
Patients should be monitored following termination of treatment because of the potential for relapse.
Pazjenti għandhom jiġu monitorati wara li jwaqqfu t- trattament minħabba li jistgħu imorru għall- agħar.
No data is available on elderly patients.
M’ hemmx tagħrif dwar pazjenti anzjani.
3 Patients with impaired hepatic function:
Suboxone mhux irrakkomandat għall- użu fit- tfal ta ’ taħt il- 15- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
The effect of hepatic impairment on the pharmacokinetics of buprenorphine and naloxone is unknown.
L- effett ta ’ indeboliment epatiku fuq il- farmakokinetika ta ’ buprenorphine u nalxone mhux magħruf.
Since both active substances are extensively metabolized, the plasma levels will be expected to be higher in patients with moderate and severe hepatic impairment.
Peress li ż- żewġ sustanzi attivi jiġu metabolizzati b’ mod estensiv, il- livelli fil- plażma jkunu mistennija li jkunu ogħla f’ pazjenti b’ indeboliment epatiku moderat u sever.
It is not known whether both active substances are affected to the same extent.
Mhux magħruf jekk iż- żewġ sustanzi attivi jiġux affettwati bl- istess mod.
As Suboxone pharmacokinetics may be altered in patients with hepatic insufficiency, lower initial doses and careful dose titration in patients with mild to moderate hepatic impairment are recommended (see section 5.2).
Peress li l- farmakokinetika ta ’ Suboxone tista ’ tinbidel f’ pazjenti b’ insuffiċjenza epatika, huwa rakkomandat li jingħataw dożi aktar baxxi fil- bidu u d- doża f’ pazjenti b’ indeboliment epatiku ħafif għal moderat tiżdied bil- kawtela (ara sezzjoni 5. 2).
Patients with impaired renal function:
Pazjenti b’ indeboliment tal- funzjoni renali:
Modification of the Suboxone dose is not required in patients with renal insufficiency.
M’ hemmx bżonn li d- doża ta ’ Suboxone tinbidel f’ pazjenti b’ insuffiċenza renali.
Caution is recommended when dosing patients with severe renal impairment (CLcr < 30 ml/ min) (see section 5.2).
Huwa rakkomandat li dożi lill- pazjenti b’ indeboliment renali sever (CLcr < 30 ml/ min) jingħataw b’ kawtela (ara sezzjoni 5. 2).
Suboxone is contraindicated in the following instances: • hypersensitivity to buprenorphine, to naloxone, or to any of the excipients, • severe respiratory insufficiency, • severe hepatic insufficiency, • acute alcoholism or delirium tremens.
Suboxone huwa kontra- indikat fil- każijiet li ġejjin: • sensittività eċċessiva għal buprenorphine, għal naloxone, jew għal xi sustanzi mhux attivi, • insuffiċjenza respiratorja severa, • insuffiċjenza epatika severa, • vizzju ta ’ l- alkoħol jew delerium tremens.
Due to the lack of data in adolescents (age 15- < 18), Suboxone should be used only with caution in this age group.
Minħabba nuqqas ta ’ informazzjoni fl- adolexxenti (età 15 - < 18), Suboxone għandu jintuża biss b’ kawtela f’ dan il- grupp ta ’ etajiet.
Patients should be closely monitored during the switching period from buprenorphine or methadone to Suboxone since withdrawal symptoms have been reported.
Il- pazjenti għandhom ikunu monitorati mill- qrib waqt li jkunu qed jaqilbu minn buprenorphine jew methadone għal Suboxone peress li kienu rrappurtati sintomi tat- twaqqif.
Diversion:
Diverżjoni:
Diversion refers to the introduction of buprenorphine into the illicit market either by patients or by individuals who obtain the medicinal product through theft from patients or pharmacies.
Diverżjoni tirreferi għall- introduzzjoni ta ’ buprenorphine fis- suq illeċitu mill- pazjenti jew minn individwi li jiksbu l- prodott mediċinali billi jisirquh minn għand il- pazjenti jew mill- ispiżeriji.
This diversion may lead to new addicts using buprenorphine as the primary drug of abuse, with the risks of overdose, spread of blood borne viral infections, respiratory depression and hepatic injury.
Din id - diverżjoni tista ’ twassal sabiex aktar nies jaqaw fil- vizzju u jużaw buprenorphine bħala id- droga ta ’ abbuż ewlenija, b’ riskju ta ’ doża eċċessiva, firxa ta ’ infezzjonijiet virali li jiġu mid- demm, depressjoni respiratorja u ħsara epatika.
Because the naloxone in the combination tablet precipitated withdrawal in individuals dependent on heroin, methadone, or other full agonists, Suboxone is expected to be less likely to be diverted for intravenous use.
Suboxone huwa mistenni li jkun anqas divertit għall- użu minn ġol- vini.
Precipitated withdrawal:
Twaqqif f’ daqqa:
When initiating treatment with buprenorphine, the physician must be aware of the partial agonist profile of buprenorphine and that it can precipitate withdrawal in opioid-dependent patients particularly if administered less than 6 hours after the last use of heroin or other short acting opioid, or if administered less than 24 hours after the last dose of methadone (see section 4.2).
Meta jinbeda t- trattament b’ buprenorphine, it- tabib għandu jkun jaf il- profil ta ’ l- agonist parzjali ta ’ buprenophine u li jista ’ jikkawża sintomi ta ’ twaqqif f’ pazjenti li jkunu dipendenti fuq opjojd l- aktar jekk jingħata f’ anqas minn 6 sigħat wara l- aħħar użu ta ’ eroina jew opjojd ieħor li jaħdem fil- qosor, jew jekk jingħata f’ anqas minn 24 siegħa wara l- aħħar doża ta ’ methadone (ara sezzjoni 4. 2).
Conversely, withdrawal symptoms may also be associated with suboptimal dosing.
Għall - kuntrarju, is- sintomi tat- twaqqif jistgħu jkunu wkoll assoċjati ma ’ dożi li jkunu anqas minn dawk xierqa.
The risk of serious undesirable effects such as overdose or treatment dropout is greater if a patient is under dosed with Suboxone and continues to self medicate withdrawal symptoms with opioids, alcohol or other sedative-hypnotics in particular benzodiazepines.
Ir- riskju ta ’ effetti mhux mixtieqa serji bħal doża eċċessiva, jew twaqqif tat- trattament huwa akbar jekk pazjent ikun mogħti doża aktar baxxa ta ’ Suboxone u jibqa jieħu l- mediċina waħdu sabiex jikkura s- sintomi tat- twaqqif b’ opjojds, alkoħol jew ipnotiċi- sedattivi oħrajn b’ mod partikolari b’ benżodijażepini.
Dependence:
4 Dipendenza:
Buprenorphine is a partial agonist at the mu-opiate receptor and chronic administration produces dependence of the opioid type.
Buprenorphine huwa agonist parzjali għar- riċettur mu- opjejt u meta jingħata b’ mod kroniku jikkawża dipendenza tat- tip opjojd.
Discontinuation of treatment may result in a withdrawal syndrome that may be delayed.
Twaqqif tat- trattament jista ’ jwassal għal sindrome tat- twaqqif li jista ’ jseħħ aktar tard.
4 Suboxone may cause drowsiness, particularly when taken together with alcohol or central nervous system depressants (such as tranquilisers, sedatives or hypnotics) (see section 4.5).
Suboxone jista ’ jikkawża n- ngħas, l- aktar jekk jittieħed flimkien ma ’ l- alkoħol jew sustanzi li jikkawżaw depressjoni tas- sistema nervuża ċentrali (bħall- kalmanti, sedattivi jew ipnotiċi) (ara sezzjoni 4. 5).
Studies in animals, as well as clinical experience, have demonstrated that buprenorphine may produce dependence but at a lower level than morphine.
Studji fl- annimali, kif ukoll esperjenza klinika, urew li buprenorphine jista ’ jikkawża dipendenza iżda b’ livelli aktar baxxi minn dawk ta ’ morphine.
Respiratory depression:
Depressjoni respiratorja:
A number of cases of death due to respiratory depression have been reported, particularly when buprenorphine was used in combination with benzodiazepines (see section 4.5), or when buprenorphine was not used according to prescribing information.
Numru ta ’ każijiet ta ’ mwiet minħabba depressjoni respiratorja kienu rrappurtati, l- aktar meta buprenorphine ntuża flimkien ma ’ benżodijażepini (ara sezzjoni 4. 5), jew meta buprenorphine ma ntużax skond l- informazzjoni preskritta.
Deaths have been reported in association with concomitant administration of buprenorphine and other depressants such as alcohol or other opioids.
Imwiet kienu rrappurtati meta buprenorphine ngħata flimkien ma ’ dipressanti oħra bħall- alkoħol jew opjojds oħrajn.
Hepatitis and hepatic events:
Epatite u każijiet epatiċi:
Cases of acute hepatic injury have been reported in opioid-dependent addicts both in clinical trials and in post marketing adverse event reports.
Każijiet ta ’ ħsara epatika akuta kienu rrappurtati f’ nies li kienu dipendenti fuq l- opjojds kemm fi provi kliniċi kif ukoll f’ rapporti ta ’ effetti avversi ta ’ wara t- tqegħid fis- suq.
The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to case reports of hepatic failure, hepatic necrosis, hepatorenal syndrome and hepatic encephalopathy.
Il- firxa ta ’ anormalitajiet tvarja minn żidiet mumentanji mingħajr sintomi ta ’ transaminases għal rapporti ta ’ każijiet ta ’ insuffiċjenza epatika, nekrożi epatika, sindrome epatorenali u enċefalopatija epatika.
In many cases the presence of pre-existing liver enzyme abnormalities, infection with hepatitis B or hepatitis C virus, concomitant use of other potentially hepatotoxic medicines, and ongoing injecting drug use may have a causative or contributory role.
F’ ħafna każijiet, il- preżenza ta ’ anormalitajiet fl- enzimi tal- fwied, infezzjonijiet b’ virus ta ’ l- epatite B jew l- epatite Ċ, l- użu fl- istess ħin ta ’ mediċini oħra li jistgħu jikkawżaw ħsara epatika, u l- injettar tad- drogi tista ’ tkun fattur li jkun qed jikkawża jew jikkontribwixxi.
These underlying factors must be taken into consideration before prescribing Suboxone and during treatment.
Dawn il- fatturi għandhom jitqiesu qabel jingħata Suboxone u waqt it- trattament.
When a hepatic event is suspected, further biological and etiological evaluation is required.
Meta jkun hemm suspett li jkun seħħ każ epatiku, huwa meħtieġ li ssir aktar evalwazzjoni bijoloġika u etjoloġika.
Depending upon the findings, the medicinal product may be discontinued cautiously so as to prevent withdrawal symptoms and to prevent a return to illicit drug use.
Skond dawn is- sejbiet, il- prodott mediċinali jista ’ jitwaqqaf b’ attenzjoni sabiex jiġu evitati sintomi tat- twaqqif u jiġi evitat li jerġa ’ jibda jsir użu illeċitu tad- droga.
If the treatment is continued, hepatic function should be monitored closely.
Jekk it- trattament jitkompla, il- funzjoni epatika għandha tkun monitorata mill- qrib.
As buprenorphine is an opioid, pain as a symptom of a disease may be attenuated.
Peress li buprenorphine huwa opjojd, l- uġigħ bħala sintomu tal- marda jista ’ jittaffa.
Athletes must be aware that this medicine may cause a positive reaction to ‘ anti-doping’ tests.
L- atleti għandhom ikunu jafu li din il- mediċina tista ’ tikkawża reazzjoni pożittiva għat- testijiet “ anti - doping ”.
As with other opioids, caution is requested in patients using buprenorphine and having head injury, increased intracranial pressure, hypotension, prostatic hypertrophy or urethral stenosis.
Bħall- opjojds oħrajn, il- kawtela hija meħtieġa f’ pazjenti li jkunu qed jużaw buprenorphine u li jkollhom xi korriment fir- ras, żieda fil- pressjoni ta ’ ġol- kranju, pressjoni baxxa, ipertrofija prostatika jew stenosi ta ’ l- uretra.
This product should be used with care in patients with: asthma or respiratory insufficiency (cases of respiratory depression have been reported with buprenorphine); renal insufficiency (30% of the administered dose is eliminated by the renal route; thus, renal elimination may be prolonged); hepatic insufficiency (hepatic metabolism of buprenorphine may be altered) (see section 4.3).
Dan il- prodott għandu jintuża b’ kawtela f’ pazjenti b ’: ażżma jew insuffiċjenza respiratorja (każijiet ta depressjoni respiratorja kienu rrappurtati b’ buprenorphine); insuffiċjenza renali (30% tad- doża mogħtija titneħħa permezz tal- kliewi, għalhekk, l- eliminazzjoni renali tista ’ tittawwal); insuffiċjenza epatika (metaboliżmu epatiku ta ’ buprenorphine jista ’ jinbidel) (ara sezzjoni 4. 3).
Medicines that inhibit the enzyme CYP3A4 may give rise to increased concentrations of buprenorphine.
Mediċini li jinibixxu l- enzima CYP3A4 jistgħu jikkawżaw żieda fil- konċentrazzjonijiet ta ’ buprenorphine.
A reduction of the Suboxone dose may be needed.
Tnaqqis tad- doża ta ’ Suboxone jista ’ jkun meħtieġ.
Patients already treated with CYP3A4 inhibitors should have their dose of Suboxone titrated carefully since a reduced dose may be sufficient in these patients (see section 4.5).
Pazjenti li jkunu ġa ttrattati b’ inibituri ta ’ CYP3A4 għandu jkollhom id- doża ta ’ Suboxone miżjuda b’ kawtela peress li doża mnaqqsa tista ’ tkun biżżejjed f’ dawn il- pazjenti (ara sezzjoni 4. 5).
The concomitant use of monoamine oxidase inhibitors (MAOI) might produce exaggeration of the effects of opioids, based on experience with morphine.
L- użu fl- istess ħin ta ’ inibituri ta ’ monomaine oxidase (MAOI) jista ’ jikkawża eżaġerazzjoni ta ’ l - effetti ta ’ l- opjojds, ibbażata fuq esperjenza bil- morphine.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ nuqqas ta ’ tolleranza għal galactose, deffiċjenza ta ’ Lapp lactase jew malassorbiment tal- glucose- galactose m’ għandhomx jieħdu din il- mediċina.
Suboxone should not be taken together with:
Suboxone m’ għandux jittieħed ma ’:
• alcoholic drinks or medications containing alcohol, as alcohol increases the sedative effect of buprenorphine (see section 4.7).
• xorb alkoħoliku jew medikazzjonijiet li jkun fihom l- alkoħol għax l- alkoħol iżid l- effett sedattiv ta ’ buprenorphine (ara sezzjoni 4. 7).
Suboxone should be used cautiously when co-administered with:
Suboxone għandu jintuża b’ kawtela meta jingħata ma ’:
5 • benzodiazepines:
• benżodijażepini:
This combination may result in death due to respiratory depression of central origin.
Din it- taħlita tista ’ twassal għall- mewt minn depressjoni respiratorja ta ’ oriġini ċentrali.
Therefore, dosages must be limited and this combination must be avoided in cases where there is a risk of misuse (see section 4.4).
Għalhekk, id- dużaġġi għandhom ikunu limitati u din it- taħlita għandha tiġi evitata f’ każijiet fejn jista ’ jkun hemm użu ħażin (ara sezzjoni 4. 4).
• other central nervous system depressants, other opioid derivatives (e. g. methadone, analgesics and antitussives), certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related substances: these combinations increase central nervous system depression.
• depressanti oħrajn tas- sistema nervuża ċentrali, derivati oħrajn tal- opjojd (eż methadone, analġeżiċi u mediċini kontra s- sogħla), ċerti mediċini kontra d- depressjoni, antagonisti sedattivi tar- riċettur- H1, barbiturati, ankżjolitiċi mhux benżodijażepini, newrolettiċi, clonidine u sustanzi relatati: dawn il- kombinazzjonijiet iżidu d- depressjoni tas- sistema nervuża ċentrali.
The reduced level of alertness can make driving and using machines hazardous.
It- tnaqqis fil- livell ta ’ kemm tista ’ tirrispondi jista ’ jagħmel is- sewqan u l- użu tal- magni perikoluż.
• CYP3A4 inhibitors: an interaction study of buprenorphine with ketoconazole (a potent inhibitor of CYP3A4) resulted in increased Cmax and AUC (area under the curve) of buprenorphine (approximately 70% and 50% respectively) and, to a lesser extent, of norbuprenorphine.
• inibituri ta ’ CYP3A4: studju ta ’ interazzjoni bejn buprenorphine u ketoconazole (inibitur qawwi ta ’ CYP3A4) wassal għal żieda tas- Cmax u AUC (erja taħt il- kurva) ta ’ buprenorphine (madwar 70% u 50% rispettivament) u, b’ mod anqas, ta ’ norbuprenorphine.
Patients receiving Suboxone should be closely monitored, and may require dose-reduction if combined with potent CYP3A4 inhibitors (e. g. protease inhibitors like ritonavir, nelfinavir or indinavir or azole antifungals such as ketoconazole or itraconazole).
Pazjenti li jkunu qed jirċievu Suboxone għandhom ikunu monitorati mill- qrib, u jistgħu jeħtieġu tnaqqis tad- doża jekk jingħataw flimkien ma ’ inibituri qawwija ta ’ CYP3A4 (eż inibituri ta ’ protease bħal ritonavir, nelfinavir jew indinavir jew mediċini kontra l- moffa azole bħal ketoconazole jew itraconazole).
• CYP3A4 inducers: the interaction of buprenorphine with CYP3A4 inducers has not been investigated.
• indutturi ta ’ CYP3A4: l- interazzjoni bejn buprenorphine u indutturi ta ’ CYP3A4 ma kenitx investigata.
Therefore it is recommended that patients receiving Suboxone should be closely monitored if inducers (e. g. phenobarbital, carbamazepine, phenytoin, rifampicin) are co- administered.
Għalhekk huwa rrikkmandat li l- pazjenti li jkunu qed jirċievu Suboxone għandhom ikunu monitorati mill- qrib jekk indutturi (eż phenobarbital, carbamazepine, phenytoin, rifampicin) jingħataw magħhom.
To date, no notable interaction has been observed with cocaine, the agent most frequently used by multi-drug abusers in association with opioids.
Sa llum, ma dehrietx interazzjoni ma ’ kokaina, is- sustanza li tintuża l- aktar minn- nies li jabbużaw minn ħafna drogi flimkien ma ’ opjojds.
There is very limited experience with buprenorphine/ naloxone in pregnant women.
Hemm esperjenza limitata ħafna b’ buprenorphine/ naloxone f’ nisa waqt it- tqala.
The potential risk for humans is unknown.
Mhux magħruf r- riskju potenzjali fuq in- nies.
Towards the end of pregnancy high doses of buprenorphine may induce respiratory depression in the neonate even after a short period of administration.
Lejn tmiem it- tqala, dożi għoljin ta ’ buprenorphine jistgħu jikkawżaw depressjoni respiratorja fit- trabi tat- twelid anki jekk ikun ngħata għal perijodu qasir.
Long-term administration of buprenorphine during the last three months of pregnancy may cause a withdrawal syndrome in the neonate.
L- għotja fit- tul ta ’ buprenorphine waqt l- aħħar tlett xhur tat- tqala jista ’ jikkawża sindrome tat- twaqqif fit- tarbija tat- twelid.
Suboxone should not be used during pregnancy.
Suboxone m’ għandux jintuża waqt it- tqala.
If it is the prescriber’ s opinion that therapy in pregnancy is required, the use of buprenorphine may be considered according to the local buprenorphine labeling.
Jekk skond it- tabib li jiktbu għandu jintuża waqt it- tqala, l - użu ta ’ buprenorphine jista ’ jitqies skond it- tiketta lokali ta ’ buprenorphine.
In case pregnancy occurs while on Suboxone treatment, the mother and the unborn child should be closely monitored and switched to buprenorphine if further treatment is required.
Jekk isseħħ tqala waqt it- trattament b’ Suboxone, l- omm u t- tarbija mhux imwielda għandhom jinżammu taħt monitoraġġ u jinqalbu għal buprenorphine jekk ikun meħtieġ aktar trattament.
It is unknown whether naloxone is excreted in human breast milk.
Mhux magħruf jekk naloxone joħroġx fil- ħalib tal- mara, fin- nies.
Buprenorphine and its metabolites are excreted in human breast milk.
Buprenorphine u l - metaboli tiegħu joħorġu fil- ħalib tas- sider fin- nies.
In rats buprenorphine has been found to inhibit lactation.
Fil- firien buprenorphine instab li jinibixxi t - treddigħ.
Therefore, breast-feeding should be discontinued during treatment with Suboxone.
Għalhekk, t- treddigħ għandu jitwaqqaf waqt kura b’ Suboxone.
In general Suboxone has minor to moderate influence on the ability to move safely in traffic, use machines, or perform other hazardous activities.
Suboxone, b’ mod ġenerali, jinfluwenza b’ mod minuri għal moderat il- ħila sabiex tiċċaqlaq b’ mod sigur fit- traffiku, tħaddem magni, jew tagħmel attivitajiet perikolużi oħra.
Suboxone may cause drowsiness, dizziness, or impaired thinking, particularly when taken together with alcohol or central nervous system depressants.
Suboxone jista ’ jikkawża n - ngħas, sturdament, ixekkel il- ħsieb, l- aktar meta jittieħed ma ’ l- alkoħol jew depressanti tas- sistema nervuża ċentrali.
Therefore caution is advised when performing the above mentioned activities (see sections 4.4 and 4.5).
Għalhekk il- kawtela hija konsiljata meta jkunu qed isiru dawn l- attivitajiet (ara sezzjonijiet 4. 4 u 4. 5).
6 The most common-treatment related undesirable effects reported during clinical trials with Suboxone were those related to withdrawal symptoms (e. g. abdominal pain, diarrhoea, muscle aches, anxiety, sweating).
L- aktar effetti mhux mixtieqa komuni, relatati mat- trattament, li kienu rrappurtati waqt il- provi kliniċi b’ Suboxone kienu dawk relatati mas- sintomi tat- twaqqif (eż uġigħ fl- addome, dijarrea, weġgħat fil - muskoli, ansjetà, għaraq).
In the pivotal clinical study of Suboxone, 342 of 472 patients (72.5%) reported treatment related adverse reactions.
Fl- istudju pivitali fuq Suboxone, 342 minn 472 pazjent (72. 5%) irrappurtaw reazzjonijiet avversi relatati mat- trattament.