qanastek/EMEA-V3 huggingface dataset:
A carcinogenicity study with Suboxone was conducted in rats at doses of 7, 30 and 120 mg/ kg/ day, with estimated exposure multiples of 3 to 75 times, based on a human daily sublingual dose of 16 mg calculated on a mg/ m² basis.
Studju ta ’ kanċeroġeniċità b’ Suboxone sar fil- firien b’ dożi ta ’ 7, 30 u 120 mg/ kg/ jum, b’ esponimenti stmati b’ multiplita ’ 3 sa 75 darba, ibbażati fuq doża ta ’ kuljum minn taħt l- ilsien fil- bniedem ta ’ 16 mg kalkulata fuq bażi ta ’ mg/ m2.
Lactose monohydrate, Mannitol, Maize starch, Povidone K 30, Citric acid anhydrous, Sodium citrate, Magnesium stearate, Acesulfame potassium, Natural lemon and lime flavour.
Lactose monohydrate, Mannitol, Maize starch, Povidone K 30, Citric acid anhydrous, Sodium citrate, Magnesium stearate, Acesulfame potassium, Togħma tal- lumi naturali u lumi qares.
26 September 2006
26 ta ’ Settembru 2006
Detailed information on this product is available on the web-site of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu.
Reckitt Benckiser Healthcare (UK) Ltd Dansom Lane Hull, East Yorkshire HU8 7DS United Kingdom
Reckitt Benckiser Healthcare (UK) Ltd Dansom Lane Hull, East Yorkshire HU8 7DS Ir- Renju Unit
Substitution treatment for opioid drug dependence is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction, within a framework of medical, social and psychological treatment, by physicians experienced in the treatment of opiate dependence/ addiction.
Trattament ta ’ sostituzzjoni għad- dipendenza fuq id- drogi opjojd huwa ntenzjonat għall- użu fl- adulti u adolexxenti li għandhom ’ l fuq minn 15- il sena li jkunu taw il- kunsens tagħhom biex jingħataw trattament għall- vizzju, f’ qafas mediku, soċjali u psikoloġiku, minn tobba b’ esperjenza fit- trattament tal- vizzju/ dipendenza ta ’ opjejt.
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
L- MAH għandu jaċċerta ruħu li jkun hemm sistema ta ’ farmakoviġilanza li taħdem qabel ma ’ l - prodott mediċinali jitqiegħed fis- suq u sakemm il- prodott li jitqiegħed fis- suq jibqa jintuża.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
L- MAH jintrabat li jagħmel l- istudji u l- attivitajiet farmakoloġiċi li hemm dettaljati fil- Pjan ta ’ Farmakoviġilanza.
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management Systems for medicinal products for human use.
Pjan ta ’ Maniġġar tar- Riskji aġġornat għandu jiġi pprovdut skond il- Linja Gwida tas- CHMP fuq is - Sistemi ta ’ Maniġġar tar- Riskji għall- prodotti mediċinali għall- użu fil- bniedem.
PACK OF 7 and 28 TABLETS 2 MG STRENGTH
PAKKETT TA ’ 7 U 28 PILLOLA QAWWA 2 MG
Suboxone 2 mg/ 0.5 mg sublingual tablets buprenorphine / naloxone
Suboxone 2 mg/ 0. 5 mg pilloli għal taħt l- ilsien buprenorphine / naloxone
Each sublingual tablet contains 2 mg buprenorphine as buprenorphine hydrochloride and 0.5 mg naloxone as naloxone hydrochloride dihydrate.
Kull pillola għal taħt l- ilsien fiha 2 mg buprenorphine bħala buprenorphine hydrochloride u 0. 5 mg naloxone bħala naloxone hydrochloride dihydrate.
Includes lactose monohydrate.
Fih ukoll lactose monohydrate.
7 sublingual tablets 28 sublingual tablets
7 pilloli għal taħt l- ilsien 28 pillola għal taħt l- ilsien
Sublingual use Do not swallow.
Użu għal taħt l- ilsien M’ għandekx tiblaha.
Keep the tablet under your tongue until it dissolves.
Żomm il- pillola taħt ilsienek sakemm tinħall.
Suboxone 2 mg/ 0.5 mg
Suboxone 2 mg/ 0. 5 mg
PACK OF 7 and 28 TABLETS 8 MG STRENGTH
PAKKETT TA ’ 7 U 28 PILLOLA QAWWA 8 MG
Suboxone 8 mg/ 2 mg sublingual tablets buprenorphine / naloxone
Suboxone 8 mg/ 2 mg pilloli għal taħt l- ilsien buprenorphine / naloxone
Each sublingual tablet contains 8 mg buprenorphine as buprenorphine hydrochloride and 2 mg naloxone as naloxone hydrochloride dihydrate.
Kull pillola għal taħt l- ilsien fiha 8 mg buprenorphine bħala buprenorphine hydrochloride u 2 mg naloxone bħala naloxone hydrochloride dihydrate.
7 sublingual tablets 28 sublingual tablets
7 pilloli għal taħt l- ilsien 28 pillolia għal taħt l- ilsien
PACK OF 7 and 28 TABLETS 2 MG STRENGTH
PAKKETT TA ’ 7 u 28 PILLOLA QAWWA 2 MG
PACK OF 7 and 28 TABLETS 8 MG STRENGTH
PAKKETT TA ’ 7 u 28 PILLOLA QAWWA 8 MG
What Suboxone is and what it is used for 2.
X’ inhu Suboxone u għalxiex jintuża 2.
Before you take Suboxone 3.
Qabel ma tieħu Suboxone 3.
How to take Suboxone 4.
Kif għandek tieħu Suboxone 4.
Possible side effects 5 How to store Suboxone 6.
Effetti sekondarji li jista ’ jkollu 5.
Further information
Kif taħżen Suboxone 6.
WHAT SUBOXONE IS AND WHAT IT IS USED FOR
X’ INHU SUBOXONE U GĦALXIEX JINTUŻA
Medicinal product used in opioid dependence.
Prodott mediċinali li jintuża għad- dipendenza fuq l- opjojd.
Suboxone is part of a medical, social and psychological treatment programme for patients addicted to opiate (narcotic) drugs.
Suboxone huwa parti mill- programm tat- trattament mediku, soċjali u psikoloġiku għal pazjenti li huma dipendenti fuq id- drogi opjejt (narkotiċi).
Treatment is prescribed and monitored by physicians who are specialists in the treatment of drug dependence.
It- trattament jinkiteb u jiġi monitorat minn tobba li huma speċjalisti fit- trattament ta ’ dipendenza fuq id- drogi.
Treatment with Suboxone sublingual tablets is intended for use in adults and adolescents over 15 years of age.
It- trattament bil- pilloli għal taħt l- ilsien, Suboxone huwa intenzjonat għall- użu f’ adulti u adolexxenti li għandhom ’ l fuq minn 15- il sena.
BEFORE YOU TAKE SUBOXONE
QABEL MA TIEĦU SUBOXONE
Do not take Suboxone
Tieħux Suboxone
- if you are allergic (hypersensitive) to buprenorphine, naloxone or any of the other ingredients of
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal buprenorphine, naloxone jew
Suboxone,
sustanzi oħra ta ’ Suboxone,
- if you have serious breathing problems,
- jekk għandek problemi serji tan- nifs,
- if you have serious problems with your liver,
- jekk għandek problemi serji tal- fwied,
- if you are intoxicated due to alcohol or have delirium tremens.
- jekk qed tbati minn tossiċità mill- alkoħol jew għandek delirium tremens.
Take special care with Suboxone Misuse and abuse Some people have died from respiratory failure (inability to breathe) because they misused buprenorphine or took it in combination with other Central Nervous System depressants, such as alcohol, benzodiazepines (tranquilisers), or other opioids.
Oqgħod attent ħafna b’ Suboxone Użu ħażin u abbuż Xi nies mietu minħabba insuffiċjenza respiratorja (ma jkunux jistgħu jieħdu nifs) minħabba li użaw b’ mod ħażin buprenorphine jew ħaduh ma ’ depressanti tas- Sistema Nervuża Ċentrali, bħall- alkoħol, benżodijażepini (kalmanti), jew opjojds oħrajn.
Cases of acute hepatic injury (liver problems) have been reported in a context of misuse, especially by intravenous route and at a high dose.
Każijiet ta ’ ħsara epatika akuta (problemi tal- fwied) kienu rrappurtati fil- kuntest ta ’ użu ħażin, speċjalment permezz ta ’ l- għotja ġol- vina b’ doża għolja.
These injuries could be due to special conditions as viral infections (chronic C hepatitis), alcohol abuse, anorexia, or medicines association (for example: antiretroviral nucleoside analogues, acetylsalicylic acid (aspirin), amiodarone, isoniazid, valproate).
Dawn il- korrimenti jistgħu jkunu ġejjin minħabba kundizzjonijiet speċjali bħal infezzjonijiet virali (epatite Ċ kronika), abbuż ta ’ l- alkoħol, anoressija, jew assoċjazzjoni mal- mediċini (per eżempju analogi tan- nuklejosidi antiretrovirali, acetylsalicylic acid (aspirin), amiodarone, isoniazid, valproate).
If you have symptoms of severe fatigue, itching, or if your skin or eyes look yellow, tell your doctor immediately, so that you can receive the proper treatment.
Jekk għandek sintomi ta ’ għeja severa, ħakk, jew jekk il- ġilda tiegħek jew għajnejk jidhru sofor, għid lit- tabib tiegħek mill- ewwel, sabiex tkun tista ’ tingħata t- trattament xieraq.
37 This product can cause withdrawal symptoms if you take it less than six hours after you use a narcotic (e. g. morphine, heroin) or less than 24 hours after you use methadone.
37 Dan il- prodott jista ’ jikkawża sintomi tat- twaqqif jekk tieħdu f’ anqas minn sitt sigħat wara li tkun użajt narkotiku (eż. morfina, eroina) jew f’ anqas minn 24 siegħa wara li tuża methadone.
This product can cause sleepiness which may be increased by alcohol or anti-anxiety medicines.
Dan il- prodott jista ’ jikkawża n- ngħas li jista ’ jiżdied bl- użu ta ’ alkoħol jew xi mediċina kontra l - ansjetà.
Advise your physician in case of:
Ħu parir tat- tabib tiegħek f’ każ:
- recent head injury or brain disease,
- ta ’ korriment fir- ras riċenti jew mard fil- moħħ,
- decrease of blood pressure,
- li titbaxxa l- pressjoni tad- demm,
- in men: urinary disorders (especially linked to enlarged prostate).
- li fl- irġiel: disturbi awrinarji (l- aktar dawk relatati ma ’ prostata li tkun kibret).
This medicinal product may mask pain reflecting some diseases.
Dan il- prodott mediċinali jista ’ jaħbi uġigħ li jindika li hemm xi mard.
Do not forget to advise your physician if you take this medicine.
Tinsiex tavża lit- tabib tiegħek jekk tieħu din il- mediċina.
This product may cause your blood pressure to drop suddenly, causing you to feel dizzy if you get up too quickly from sitting or lying down.
Dan il- prodott mediċinali jista ’ jwaqqa ’ l- pressjoni tad- demm f’ daqqa, li ġġiegħelek tħossok sturdut jekk tqum bil- wieqfa malajr wisq minn bil- qiegħeda jew mindud.
This product can cause dependence.
Dan il- prodott jista’ jikkawża dipendenza.
Athletes should be aware that this medicine, due to its active substance, may cause a positive reaction to “ anti-doping tests”.
L- atleti għandhom iżommu f’ rashom li din il- mediċina, minħabba s- sustanza attiva li fiha, tista ’ tikkawża reazzjoni pożittiva għat- testijiet “ anti- doping ”.
Advise your physician in case of:
Avża lit- tabib tiegħek f’ każ ta ’
- asthma or other breathing problems,
- ażżma jew problemi oħra tan- nifs,
- kidney disease,
- mard tal- kliewi,
- liver disease.
- mard tal- fwied.
Using other medicines Using other medicines may increase the undesirable effects of buprenorphine and use of these medicines must be carefully monitored: • tranquilizers • anti-anxiety medicines • anti-depressants • benzodiazepines • some medicines used to treat high blood pressure.
Meta tuża mediċini oħra Meta tuża mediċini oħra jistgħu jiżdiedu l- effetti mhux mixtieqa ta ’ buprenorphine u l- użu ta ’ dawn il - mediċini għandu jkun monitorat b’ attenzjoni: • kalmanti • mediċini kontra l- ansjetà • mediċini kontra d- depressjoni • benżodijażepini • xi mediċini li jintużaw għall- kura ta ’ pressjoni għolja tad- demm.
If your physician prescribes benzodiazepines, you must not take more than the prescribed dose.
Jekk it- tabib tiegħek jordnalek benżodijażepini, m’ għandekx tieħu aktar mid- doża li jordnalek.
Taking this product with benzodiazepines (medicines used to treat anxiety or sleep disorders) may cause death due to respiratory failure.
It- teħid ta ’ dan il- prodott ma ’ benżodijażepini (mediċini li jintużaw għall- kura ta ’ ansjetà jew disturbi fl- irqad) jista ’ jikkawża l- mewt minħabba insuffiċjenza respiratorja.
The following medicines may increase the buprenorphine blood concentrations, so concomitant use of these medicines together with Suboxone should be closely monitored and could require in some cases a dose reduction by your doctor: • anti-retrovirals (ritonavir, nelfinavir, indinavir) • ketoconazole • itraconazole
Il- mediċini li ġejjin jistgħu jżidu il- konċentrazzjonijiet ta ’ buprenorphine fid- demm, għalhekk l- użu fl - istess ħin ta ’ dawn il- mediċini ma ’ Suboxone għandu jkun monitorat mill- qrib u jista ’ jkollu bżonn f’ xi każijiet tnaqqis tad- doża mit- tabib tiegħek: • mediċini anti- retrovirali (ritonavir, nelfinavir, indinavir) • ketoconazole • itraconazole
Using Suboxone with food and drink Do not take Suboxone together with alcoholic beverages as alcohol may possibly increase drowsiness induced by Suboxone.
Meta tuża Suboxone ma ’ l- ikel u max- xorb Tieħux Suboxone ma ’ xorb alkoħoliku għax l- alkoħol jista ’ jżid in- ngħas ikkawżat minn Suboxone.
38 Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
38 M’ għandekx tuża Suboxone waqt it- tqala.
Tell your doctor if you are pregnant or intend to become pregnant.
Għid lit- tabib tiegħek jekk ħriġt tqila jew bi ħsiebek toħroġ tqila.
He will decide if your treatment should be continued with an alternative medication.
Hu jiddeċiedi jekk it- trattament tiegħek għandux jitkompla b’ mediċina oħra.
Since this product will pass into your milk and may adversely affect the breast-fed child, you should discontinue breast-feeding while taking Suboxone.
Peress li dan il- prodott jgħaddi fil- ħalib tiegħek u jista ’ jeffettwa b’ mod avvers lit- tarbija li tkun qed titredda ’, għandek twaqqaf it- treddigħ waqt li tkun qed tieħu Suboxone.
Driving and using machines Suboxone may cause drowsiness.
Sewqan u tħaddim ta ’ magni Suboxone jista ’ jħeddel.
If you feel tired, do not drive a motor vehicle or operate machinery.
Jekk tħossok għajjien, m’ għandekx issuq vetturi jew tħaddem magni.
Important information about some of the ingredients of Suboxone Suboxone contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Suboxone Suboxone fih lactose.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib qallek li għandek intolleranza għal ċerti tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
HOW TO TAKE SUBOXONE
KIF GĦANDEK TIEĦU SUBOXONE
Sublingual route is the only efficacious administration route for this product.
Il- mezz ta ’ taħt l- ilsien huwa l- unika mezz effettiv biex jingħata dan il- prodott.
Do not swallow the tablets.
Tiblax il- pilloli.
Keep the tablet dose under your tongue until it dissolves.
Żomm il- pillola taħt ilsienek sakemm tinħall.
This may take 5-10 minutes.
Dan jista ’ jdum minn 5- 10 minuti.
Take the dose once a day.
Ħu d- doża darba kuljum.
Your doctor will determine the best dose for you.
It- tabib tiegħek ser jiddeċiedi l- aħjar doża għalik.
During your treatment, the doctor may adjust the dose, depending upon your response.
Waqt it- trattament, it- tabib jista ’ jaġġusta d- doża, skond ir- respons li jkollok.
To get the greatest benefit from taking Suboxone, you must tell your doctor about all the medicines you are taking, including alcohol, medicines containing alcohol, street drugs, and any prescription medicine you are taking that have not been prescribed to you by your doctor.
Sabiex ikollok l- aqwa benefiċċju meta tieħu Suboxone, għandek tgħid lit - tabib tiegħek dwar il- mediċini kollha li qed tieħu, inkluż l- alkoħol, mediċini li fihom l- alkoħol, drogi li jinxtraw mit- triq, jew xi mediċini bir- riċetta li qed tieħu mingħajr l- ordni tat- tabib tiegħek.
After the first dose of Suboxone, it is possible that you may have some opiate withdrawal symptoms, see section 4 ‘ POSSIBLE SIDE EFFECTS’.
Wara l- ewwel doża ta ’ Suboxone, jista ’ jkun li jkollok xi sintomi ta ’ twaqqif ta ’ opjejt, ara sezzjoni 4 ‘ EFFETTI SEKONDARJI LI JISTA ’ JKOLLU ’.
Treatment duration The length of treatment will be determined individually by your doctor.
Kemm idum it- trattament It- tul tat- trattament jiġi deċiż b’ mod individwali mit- tabib tiegħek.
After a time of successful treatment, the doctor may reduce the dose gradually to a lower maintenance dose.
Wara żmien ta ’ trattament b’ suċċess, it- tabib jista ’ jnaqqas id- doża bil- mod għal doża ta ’ manteniment aktar baxxa.
Depending on your condition, the Suboxone dose may continue to be reduced under careful medical supervision, until eventually it may be stopped.
Skond il- kundizzjoni tiegħek, id- doża ta ’ Suboxone tista ’ tkompli titnaqqas taħt superviżjoni medika b’ attenzjoni, sakemm fl- aħħar titwaqaf.
Do not change the treatment in any way or stop treatment without the agreement of the doctor who is treating you.
Tibdilx it- trattament bl- ebda mod jew twaqqaf it- trattament mingħajr ftehim mat- tabib li qed jagħtik it - trattament.
The effectiveness of this treatment depends:
L- effikaċja ta ’ dan it- trattament jiddependi:
- on the dose,
- mid- doża
- in combination with the associated medical, psychological and social treatment.
- mill- kombinazzjoni tat- trattament mediku, psikoloġiku u soċjali assoċjat mal- kura.
If you have the impression that the effect of Suboxone is too strong or too weak, talk to your doctor or pharmacist.
Jekk għandek l- impressjoni li l- effett ta ’ Suboxone huwa qawwi wisq jew dgħajjef wisq, kellem lit - tabib jew lill- ispiżjar tiegħek.
If you use more Suboxone than you should In case of overdose of buprenorphine, you must go or be taken immediately to an emergency centre or hospital for treatment.
Jekk tuża Suboxone aktar milli suppost F’ każ ta ’ doża eċċessiva ta ’ buprenorphine, għandek tmur jew tittieħed mill- ewwel f’ ċentru ta ’ emerġenza jew sptar għat- trattament.
Advise immediately your doctor or your pharmacist.
Avża mill- ewwel lit- tabib jew lill- ispiżjar tiegħek.
If you forget to use Suboxone
Jekk tinsa tuża Suboxone Għamel kuntatt mat- tabib tiegħek.
If you stop using Suboxone Stopping treatment suddenly may cause withdrawal symptoms.
Jekk tieqaf tuża Suboxone It- twaqqif f’ daqqa tat- trattament jista ’ jwassal għal sintomi tat- twaqqif.
Like all medicines, Suboxone can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Suboxone jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
After the first dose of Suboxone, you may have some opiate withdrawal symptoms, see section 3 ‘ HOW TO TAKE SUBOXONE’.
Wara l- ewwel doża ta ’ Suboxone, jista ’ jkollok xi sintomi tat- twaqqif ta ’ l- opjejt, ara sezzjoni 3 ‘ KIF GĦANDEK TIEĦU SUBOXONE ’.
Very common side effects (occurring in at least 1 in 10 patients) that may occur with Suboxone are: insomnia, constipation, nausea, sweating, headache, withdrawal syndrome.
Effetti sekondarji komuni ħafna (li jseħħu f’ mill- anqas 1 minn kull10 pazjenti) li jistgħu jseħħu b’ Suboxone huma: nuqqas ta ’ rqad, stitikezza, dardir, għaraq, uġigħ ta ’ ras, sindrome tat- twaqqif.
Common side effects (occurring in at least 1 in 100 patients) that may occur during treatment with Suboxone are: weight loss, swelling (hands and feet), tiredness, drowsiness, anxiety, nervousness, tingling, depression, decreased sexual drive, muscle spasms, abnormal thinking, tearing disorder, blurred vision, flushing, increased blood pressure, migraines, runny nose, sore throat and painful swallowing, increased cough, upset stomach, diarrhoea, abnormal liver function, loss of appetite, flatulence, vomiting, rash, itching, hives, pain, joint pain, muscle pain, leg cramps, impotence, urine abnormality, abdominal pain, back pain, weakness, infection, chills, chest pain, fever, flu syndrome, feeling of general discomfort, accidental injury, faintness and dizziness, drop in blood pressure on changing position from sitting or lying down to standing.
Effetti sekondarji komuni (li jseħħu f’ mill- anqas 1 minn kull 100 pazjent) li jistgħu jseħħu waqt it - trattament b’ Suboxone huma: tnaqqis fil- piż, nefħa (idejn u saqajn), għeja, ngħas, ansjetà, nervi, tingiż, depressjoni, tnaqqis fl- aptit għas- sess, spażmi fil- muskoli, ħsibijiet mhux normali, disturbi fid - dmugħ, vista mċajpra, fwawar, titla ’ l- pressjoni tad- demm, attakki tal- emigranja, imnieħer inixxi, grieżem misluħa u tweġġa biex tibla ’, żieda fis- sogħla, stonku mqalleb, dijarrea, funzjoni tal- fwied mhux normali, titlef l- aptit, gass fl- istonku, rimettar, raxx, ħakk, ħorriqija, uġigħ, uġigħ fil- ġogi, uġigħ fil- muskoli, bugħawwieġ fir- riġlejn, impotenza, awrina anormali, uġigħ fl- addome, uġigħ fid- dahar, debbolezza, infezzjoni, dehxiet ta ’ bard, uġigħ fis- sider, deni, sindrome li tixbah l- influwenza, tħossok jew ikollok skumdità b’ mod ġenerali, korriment aċċidentali, iħossok ħass ħażin u tistordi, taqa ’ l - pressjoni tad- demm meta tibdel il- pożizzjoni minn bil- qiegħda jew mindud għal bil- wieqfa.
Uncommon side effects (occurring in at least 1 in 1,000 patients) with Suboxone are: swollen glands (lymph nodes), agitation, tremor, abnormal dream, excessive muscle activity, depersonalization (not feeling like yourself), medicine dependence, amnesia (memory disturbance), loss of interest, exaggerated feeling of well being, convulsion (fits), speech disorder, small pupil size, problems with urination, conjunctivitis, rapid or slow heart beat, low blood pressure, palpitations, myocardial infarction (heart attack), shortness of breath, asthma, yawning, pain and sores in mouth, tongue discolouration, acne, skin nodule, hair loss, dry or scaling skin, inflammation of joints, urinary tract infection, blood in urine, abnormal ejaculation, menstrual or vaginal problems, kidney stone, sensitivity to heat or cold, allergic reaction, feelings of hostility.
Effetti sekondarji mhux komuni (li jseħħu f’ mill- anqas 1 minn kull 1, 000 pazjent) b’ Suboxone huma: glandoli minfuħin (nodi tal- limf), aġitazzjoni, rogħda, ħolm anormali, attività eċċessiva tal- muskoli, telf tal- personalità (tħossok persuna oħra), dipendenza fuq il- mediċina, amneżija (disturbi fil - memorja), titlef l- interess, sensazzjoni tajba esaġerata, konvulżjoni (aċċesjonijiet), problemi biex titkellem, il- ħabba ta ’ l- għajn tiċkien problemi biex tgħaddi l- awrina, konġunktivite, il- qalb tħabbat mgħaġġla jew bil- mod, titbaxxa l- pressjoni tad- demm, palpitazzjonijiet, infart mijokardijaku (attakk tal- qalb), qtugħ ta ’ nifs, ażżma, titwib, uġigħ u selħiet fil- ħalq, telf tal- kulur fl- ilsien, akne, noduli fil - ġilda, telf tax- xagħar, ġilda tixxotta jew titqaxxar, infjammazzjoni tal- ġogi, infezzjoni fil- passaġġ ta ’ l - awrina demm fl- awrina, ejakulazzjoni mhux normali, problemi mestruwali jew fil- vaġina, ġebla fil - kilwa, tħoss aktar il- kesħa jew is- sħana, reazzjoni allerġika, sensazzjonijiet ta ’ ostilità.
Rarely (occurring in at least 1 in 10,000 patients), the following have occurred with buprenorphine alone:
Rarament (iseħħu f’ mill- anqas 1 minn kull 10, 000 pazjent), dawn li ġejjin seħħew b’ buprenorphine mogħti waħdu:
- respiratory depression (severe difficulty in breathing) - see “ Take special care with Suboxone”,
- depressjoni respiratorja (tbati b’ mod sever biex tieħu n- nifs) – ara “ Oqgħod attent ħafna
- liver problems with or without jaundice- see “ Take special care with Suboxone”,
- problemi fil- fwied bis- suffejra jew mingħajrha – ara “ Oqgħod attent ħafna b’ Suboxone ”
- hallucinations.
- alluċinazzjonijiet.
Misusing this medicine by injecting it can cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems - see “ Take special care with Suboxone”.
Jekk tuża din il- mediċina b’ mod ħażin billi tinjettha tista ’ tikkawża sintomi ta ’ twaqqif, infezzjonijiet, reazzjonijiet tal- ġilda oħrajn u problemi serji fil- fwied – ara “ Oqgħod attent ħafna b’ Suboxone ”.
HOW TO STORE SUBOXONE
KIF TAĦŻEN SUBOXONE
Do not use Suboxone after the expiry date which is stated on the carton.
Tużax Suboxone wara d- data ta ’ skadenza li tidher fuq il- kartuna.
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali m’ għandux bżonn ta ’ kundizzjonijiet speċjali għall- ħażna.
Medicines should not be disposed of via wastewater or household waste.
40 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Suboxone contains
X’ fih Suboxone:
- The active substance is buprenorphine and naloxone.
- Is- sustanza attiva hi buprenorphine u naloxone.
Each tablet contains 2 mg buprenorphine
Kull pillola fiha 2 mg buprenorphine bħala
as buprenorphine hydrochloride and 0.5 mg naloxone as naloxone hydrochloride dihydrate.
buprenorphine hydrochloride u 0. 5 mg naloxone bħala naloxone hydrochloride dihydrate.
- The other ingredients are lactose monohydrate, mannitol, maize starch, povidone K30, citric
- Is- sustanzi l- oħra huma lactose monohydrate, mannitol, maize starch, povidone K30, citric acid
acid anhydrous, sodium citrate, magnesium stearate, acesulfame potassium and natural lemon and lime flavour.
anhydrous, sodium citrate, magnesium stearate, acesulfame potassium u togħma tal- lumi naturali u lumi qares.
What Suboxone looks like and contents of the pack
Id- Dehra ta ’ Suboxone u l- kontenuti tal- pakkett:
Sublingual tablets, white hexagonal biconvex tablets, embossed with a sword logo on one side and “ N2” on the reverse side, packed in packs of 7 and 28 tablets.
Pilloli għal taħt l- ilsien, bojod eżagonali konvessi fuq iż- żewġ naħat, minquxa b’ logo ta ’ xabla fuq naħa u “ N2 ” fuq in- naħa l- oħra, ippakkjati f’ pakketti ta ’ 7 u 28 pillola.
Manufacturer:
SP Europe, Rue de Stalle 73, B- 1180 Bruxelles, Il- Belġju Manifattur:
Reckitt Benckiser Healthcare (UK) Ltd, Dansom Lane, Hull, East Yorkshire HU8 7DS, United Kingdom.
Reckitt Benckiser Healthcare (UK) Ltd, Dansom Lane, Hull, East Yorkshire HU8 7DS, Ir - Renju Unit
41 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Ελλάδα Αγίου Δημητρίου 63 GR-174 55 Άλιμος Tηλ.: + 30-210 98 97 300
Polska Ελλάδα Αγίου Δημητρίου 63 GR- 174 55 Άλιμος Tηλ.: + 30- 210 98 97 300
7, sector 1 RO-013682 Bucureş ti Tel: + 40 21 233 35 30
7, sector 1 F- 92300 Levallois- Perret RO- 013682 Bucureşti Tél: + 33 - (0) 1 41 06 35 00 Tel. + 40 21 233 35 30
65/ 40 LT-08124 Vilnius Tel: + 370 52 101868
65/ 40 LT- 08124 Vilnius Tel. + 370 52 101868
Detailed information on this product is available on the web-site of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
What Suboxone is and what it is used for 2.
X’ inhu Suboxone u għalxiex jintuża 8.
Before you take Suboxone 3.
Qabel ma tieħu Suboxone 9.
How to take Suboxone 4.
Kif għandek tieħu Suboxone 10.
Possible side effects 5 How to store Suboxone 6.
Effetti sekondarji li jista ’ jkollu 11.
Further information
Kif taħżen Suboxone 12.
Treatment with Suboxone sublingual tablets is intended for use in adults and adolescents over 15 years of age.
It- trattament bil- pilloli għal taħt l- ilsien Suboxone huwa intenzjonat għall- użu f’ adulti u adolexxenti li għandhom ’ l fuq minn 15- il sena.
Cases of acute hepatic injury (liver problems) have been reported in a context of misuse, especially by intravenous route and at a high dose.
Każijiet ta ’ ħsara epatika akuta (problemi tal- fwied) kienu rrappurtati fil- kuntest ta ’ użu ħażin, speċjalmentpermezz ta ’ l- għotja ġol- vina b’ doża għolja.
44 This product can cause withdrawal symptoms if you take it less than six hours after you use a narcotic (e. g. morphine, heroin) or less than 24 hours after you use methadone.
44 Dan il- prodott jista ’ jikkawża sintomi tat- twaqqif jekk tieħdu f ’ anqas minn sitt sigħat wara li tkun użajt narkotiku (eż. morfina, eroina) jew f’ anqas minn 24 siegħa wara li tuża methadone.
Advise your physician in case of:
Avża lit lit- tabib tiegħek f’ każ ta ’
Using other medicines Using other medicines may increase the undesirable effects of buprenorphine and use of these medicines must be carefully monitored: • tranquilizers • anti-anxiety medicines • anti-depressants • benzodiazepines • some medicines used to treat high blood pressure.
Meta tuża mediċini oħra Meta tuża mediċini oħra jistgħu jiżdiedu l- effetti mhux mixtieqa ta ’ buprenorphine u l- użu ta ’ dawn il - mediċini għandu jkun monitorat b’ attenzjoni: • kalmanti • mediċini kontra l- ansjetà • mediċini kontra d- depressjoni • benżodijażepini • xi mediċini li jintużaw għal kura ta ’ pressjoni għolja tad- demm.
Taking this product with benzodiazepines (medicines used to treat anxiety or sleep disorders) may cause death due to respiratory failure.
It- teħid ta ’ dan il- prodott ma ’ benżodijażepini (mediċini li jintużaw għal kura ta ’ ansjetà jew disturbi fl- irqad) jista ’ jikkawża l- mewt minħabba insuffiċjenza respiratorja.
45 Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
45 M’ għandekx tuża Suboxone waqt it- tqala.
Common side effects (occurring in at least 1 in 100 patients) that may occur during treatment with Suboxone are: weight loss, swelling (hands and feet), tiredness, drowsiness, anxiety, nervousness, tingling, depression, decreased sexual drive, muscle spasms, abnormal thinking, tearing disorder, blurred vision, flushing, increased blood pressure, migraines, runny nose, sore throat and painful swallowing, increased cough, upset stomach, diarrhoea, abnormal liver function, loss of appetite, flatulence, vomiting, rash, itching, hives, pain, joint pain, muscle pain, leg cramps, impotence, urine abnormality, abdominal pain, back pain, weakness, infection, chills, chest pain, fever, flu syndrome, feeling of general discomfort, accidental injury, faintness and dizziness, drop in blood pressure on changing position from sitting or lying down to standing.
Effetti sekondarji komuni (li jseħħu f’ mill- anqas 1 minn kull 100 pazjent) li jistgħu jseħħu waqt it - trattament b’ Suboxone huma: tnaqqis fil- piż, nefħa (idejn u saqajn), għeja, ngħas, ansjetà, nervi, tingiż, depressjoni, tnaqqis fl- aptit għas- sess, spażmi fil- muskoli, ħsibijiet mhux normali, disturbi fid - dmugħ, vista mċajpra, fwawar, titla ’ l- pressjoni tad- demm, attakki tal- migranja, imnieħer inixxi, grieżem misluħa u tweġġa biex tibla ’ żieda fis- sogħla, stonku mqalleb, dijarrea, funzjoni tal- fwied mhux normali, titlef l- aptit, gass fl- istonku, rimettar, raxx, ħakk, ħorriqija, uġigħ, uġigħ fil- ġogi, uġigħ fil- muskoli, bugħawwieġ fir- riġlejn, impotenza, awrina anormali, uġigħ fl- addome, uġigħ fid- dahar, debbolezza, infezzjoni, dehxiet ta ’ bard, uġigħ fis- sider, deni, sindrome li tixbah l- influwenza, tħossok jew ikollok skumdità b’ mod ġenerali, korriment aċċidentali, iħossok ħass ħażin u tistordi, taqa ’ l - pressjoni tad- demm meta tibdel il- pożizzjoni minn bil- qiegħda jew mindud għal bil- wieqfa.
Uncommon side effects (occurring in at least 1 in 1,000 patients) with Suboxone are: swollen glands (lymph nodes), agitation, tremor, abnormal dream, excessive muscle activity, depersonalization (not feeling like yourself), medicine dependence, amnesia (memory disturbance), loss of interest, exaggerated feeling of well being, convulsion (fits), speech disorder, small pupil size, problems with urination, conjunctivitis, rapid or slow heart beat, low blood pressure, palpitations, myocardial infarction (heart attack), shortness of breath, asthma, yawning, pain and sores in mouth, tongue discolouration, acne, skin nodule, hair loss, dry or scaling skin, inflammation of joints, urinary tract infection, blood in urine, abnormal ejaculation, menstrual or vaginal problems, kidney stone, sensitivity to heat or cold, allergic reaction, feelings of hostility.
Effetti sekondarji mhux komuni (li jseħħu f’ mill- anqas 1 minn kull 1, 000 pazjent) b’ Suboxone huma: glandoli minfuħin (nodi tal- limf), aġitazzjoni, rogħda, ħolm anormali, attività eċċessiva tal- muskoli, telf tal- personalità (tħossok persuna oħra), dipendenza fuq il- mediċina, amneżija (disturbi tal - memorja), titlef l- interess, sensazzjoni tajba esaġerata, konvulżjoni (aċċesjonijiet), problemi biex titkellem, il- ħabba ta ’ l- għajn tiċkien, problemi biex tgħaddi l- awrina, konġunktivite, il- qalb tħabbat mgħaġġla jew bil- mod, titbaxxa l- pressjoni tad- demm, palpitazzjonijiet, infart mijokardijaku (attakk tal- qalb), qtugħ ta ’ nifs, ażżma, titwib, uġigħ u selħiet fil- ħalq, telf tal- kulur fl- ilsien, akne, noduli fil - ġilda, telf tax- xagħar, ġilda tixxotta jew titqaxxar, infjammazzjoni tal- ġogi, infezzjoni fil- passaġġ ta ’ l - awrina demm fl- awrina, ejakulazzjoni mhux normali, problemi mestruwali jew fil- vaġina, ġeblafil - kilwa, tħoss aktar il- kesħa jew is- sħana, reazzjoni allerġika, sensazzjonijiet ta ’ ostilità.
Rarely (occurring in at least 1 in 10,000 patients), the following have occurred with buprenorphine alone:
Rarament (iseħħu f’ mill- anqas 1 minn kull 10, 000 pazjent), dawn li ġejjin seħħew bi buprenorphine mogħti waħdu:
Medicines should not be disposed of via wastewater or household waste.
47 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Suboxone contains
X’ fih Suboxone
Each tablet contains 8 mg buprenorphine
Kull pillola fiha 8 mg buprenorphine bħala
as buprenorphine hydrochloride and 2 mg naloxone as naloxone hydrochloride dihydrate.
buprenorphine hydrochloride u 2 mg naloxone bħala naloxone hydrochloride dihydrate.
Sublingual tablets, white hexagonal biconvex tablets, embossed with a sword logo on one side and “ N8” on the reverse side, packed in packs of 7 and 28 tablets.
Pilloli għal taħt l- ilsien, bojod eżagonali konvessi fuq iż- żewġ naħat, minquxa b’ logo ta ’ xabla fuq naħa u “ N8 ” fuq in- naħa l- oħra, ippakkjati f’ pakketti ta ’ 7 u 28 pillola.
48 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa
bottle (HDPE) bottle (HDPE) bottle (HDPE) blister (alu/ PVC)
flixkun (HDPE) flixkun (HDPE) flixkun (HDPE) folja (alu/ PVC)
30 capsules 30 capsules 90 capsules 42 capsules
30 kapsula 30 kapsula 90 kapsula 42 kapsula
Oral solution Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Soluzzjoni orali Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita
bottle (HDPE) bottle (HDPE) blister (alu) HDPE bottle blister (Alu) blister (alu/ PVC)
flixkun (HDPE) flixkun (HDPE) folja (alu) Flixkun tal- HDPE folja (Alu) folja (alu/ PVC)
1 bottle + 1 syringe 60 tablets 60 tablets 30 tablets 30 tablets 90 tablets (3x30x1)
1 flixkun + 1 siringa 60 pillola 60 pillola 30 pillola 30 pillola 90 pillola (3x30x1)
What is Sustiva?
X’ inhu Sustiva?
Sustiva is a medicine that contains the active substance efavirenz.
Sustiva huwa mediċina li fiha s- sustanza attiva efavirenz.
200 mg), as yellow, capsule-shaped tablets (600 mg) and as an oral solution (30 mg/ ml).
200 mg), f’ pilloli f’ forma ta ’ kapsuli sofor (600 mg) u f’ soluzzjoni orali (30 mg/ ml).
What is Sustiva used for?
Għal xiex jintuża Sustiva?
Sustiva is an antiviral medicine.
Sustiva huwa mediċina antivirali.
How is Sustiva used?
Kif jintuża Sustiva?
Treatment with Sustiva should be started by a doctor who has experience in the management of HIV infection.
It- terapija b’ Sustiva għandha tinbeda minn tabib li jkollu esperjenza fit- trattament tal- infezzjoni mill - HIV.
Sustiva must be given in combination with other antiviral medicines.
Sustiva għandu jintuża f’ kombinazzjoni ma ’ mediċini antivirali oħra.
It is recommended that Sustiva be taken on an empty stomach and without food, preferably at bedtime.
Huwa rakkomandat li Sustiva jittieħed fuq stonku vojt u mingħajr ikel, preferibbilment qabel il- ħin tal- irqad.
The recommended dose of Sustiva for adults is 600 mg once a day.
Id- doża rakkomandata ta ’ Sustiva għall- adulti hija 600 mg darba kuljum.
For patients who are unable to swallow the capsules or tablets, Sustiva can be given using the oral solution.
Il- pazjenti li ma jistgħux jibilgħu l- kapsuli jew il- pilloli, jistgħu jieħdu Sustiva f’ soluzzjoni orali.
If the patient cannot tolerate the oral solution, mixing the contents of the capsules with a small amount of food (around two teaspoons) can be considered.
Jekk il- pazjent ma jistax jittollera s- soluzzjoni orali, jista ’ jiġi kkunsidrat li l- kontenut tal- kapsuli jitħallat ma ’ kwantità żgħira tal- ikel (madwar żewġ kuċċarini).
The dose of Sustiva needs to be reduced in patients taking voriconazole (used to treat fungal infections).
F’ pazjenti ttrattati b’ voriconazole (użat għat- trattament ta ’ infezzjonijiet fungali), jeħtieġ li titnaqqas id- doża ta ’ Sustiva.
Patients taking rifampicin (an antibiotic) may need to take a higher dose of Sustiva.
Il- pazjenti ttrattati b’ rifampiċina (rifampicin, antibijotiku) aktarx ikunu jeħtieġu doża aktar qawwija ta ’ Sustiva.
How has Sustiva been studied?
Kif jaħdem Sustiva?
Sustiva has been studied in three main studies involving over 1,100 adults:  in the first study, Sustiva in combination with lamivudine and zidovudine or with indinavir (other antiviral medicines) was compared with the combination of indinavir, lamivudine and zidovudine;  the second study compared Sustiva in combination with nelfinavir and two other antiviral medicines with the same combination without Sustiva;  the third study compared adding Sustiva or placebo (a dummy treatment) to a combination of antiviral medicines that included indinavir and two other antiviral medicines, in patients who had already been receiving treatment for HIV infection.
 fl- ewwel studju, Sustiva f’ kombinazzjoni mal- lamivudina (lamivudine) u z- zidovudina (zidovudine) jew ma ’ indinavir (mediċini antivirali oħra), tqabbel ma ’ kombinazzjoni ta ’ indinavir, lamivudina u zidovudina.  fit- tieni studju qabbel Sustiva f’ kombinazzjoni ma ’ nelfinavir u żewġ mediċini antivirali oħra mal - istess kombinazzjoni mingħajr Sustiva.  fit- tielet studju qabbel iż- żieda ta ’ Sustiva jew plaċebo (trattament finta) ma ’ kombinazzjoni ta ’ mediċini antivirali li kienu jinkludu indinavir u żewġ mediċini antivirali oħra, f’ pazjenti li diġà kienu qed jingħataw trattament għall- infezzjoni mill- HIV.
Sustiva has also been studied in 57 children aged between three and 16 years, in combination with nelfinavir and other antiviral medicines.
Sustiva ġie studjat ukoll f’ 57 tifel u tifla ta ’ etajiet bejn tliet snin u 16- il sena, f’ kombinazzjoni ma ’ nelfinavir u mediċini antivirali oħra.
What benefit has Sustiva shown during the studies?
X’ inhuma l- benefiċċji li wera Sustiva f’ dawn l- istudji?
70% and 30% of the patients, respectively, had viral loads below 500 copies/ ml after 48 weeks;  the third study showed that more patients receiving Sustiva had viral loads below 400 copies/ ml than those taking placebo after 24 weeks.
L- istudji kollha wrew li l- kombinazzjonijiet li kienu jinkludu Sustiva kienu tal- anqas effikaċi daqs il - mediċini ta ’ tqabbil:  l- ewwel studju wera li f’ 67% tal- adulti ttrattati b’ Sustiva f’ kombinazzjoni ma ’ zidovudina u lamivudina ġiet osservata tagħbija virali taħt l- 400 kopja/ ml wara 48 ġimgħa, meta mqabbla ma ’ 54% ta ’ dawk ittrattati b’ Sustiva u indinavir, u 45% ta ’ dawk ittrattati b’ indinavir, lamivudina u zidovudina;  fit- tieni studju, Sustiva f’ kombinazzjoni ma ’ nelfinavir kien superjuri għall- kombinazzjoni mingħajr Sustiva: f’ 70% u f’ 30% tal- pazjenti, rispettivament, ġiet osservata tagħbija virali taħt il - 500 kopja/ ml wara 48 ġimgħa.  fit- tielet studju wera li f’ aktar pazjenti ttrattati b’ Sustiva ġiet osservata tagħbija virali taħt l - 400 kopja/ ml minn f’ dawk ittrattati bi plaċebo wara 24 ġimgħa.
What is the risk associated with Sustiva?
X’ inhu r- riskju assoċjat ma ’ Sustiva?
The most common side effect with Sustiva (seen in more than 1 patient in 10) is rash.
L- effett sekondarju l- aktar komuni b’ Sustiva (li deher f’ aktar minn pazjent 1 minn 10) hu raxx.
Sustiva is also associated with nervous system symptoms, such as dizziness, insomnia (difficulty sleeping), somnolence (sleepiness), impaired concentration and abnormal dreaming, and with psychiatric disorders, including severe depression, suicidal thoughts, suicide attempts and aggressive behaviour, especially in patients with a history of mental illness.
Sustiva huwa assoċjat ukoll ma ’ sintomi marbuta mas- sistema nervuża bħal sturdament, insonnja (diffikultà fl- irqad), ħedla tan- ngħas, diffikultà ta ’ konċentrazzjoni u ħolm mhux normali, u disturbi psikjatriċi fosthom depressjoni gravi, ħsibijiet ta ’ suwiċidju, tentattivi ta ’ suwiċidju u mġiba aggressiva, speċjalment f’ pazjenti bi storja ta ’ mard mentali.
Taking Sustiva with food may lead to an increase in the frequency of side effects.
It- teħid ta ’ Sustiva mal- ikel jista ’ jwassal għal żieda fil- frekwenza ta ’ effetti sekondarji.
For a more complete list of side effects reported with Sustiva, see the Package Leaflet.
Għal lista aktar sħiħa tal- effetti sekondarji rrapportati b’ Sustiva, ara l- Fuljett ta ’ Tagħrif.
Sustiva should not be used in patients who may be hypersensitive (allergic) to efavirenz or any of the other ingredients.
Sustiva ma għandux jintuża f’ pazjenti li jistgħu jkunu ipersensittivi (allerġiċi) għal efavirenz jew għal kwanlunkwe mill- ingredjenti l- oħra.
It must not be used in patients with severe liver disease or who are taking any of the following medicines:  astemizole, terfenadine (commonly used to treat allergy symptoms - these medicines may be available without prescription);  dihydroergotamine, ergotamine, ergonovine, methylergonovine (used to treat migraine headache);  midazolam, triazolam (used to relieve anxiety or difficulty sleeping);  pimozide (used to treat mental illnesses);  cisapride (used to relieve certain stomach problems);  bepridil (used to treat angina);  St John ’ s wort (a herbal preparation used to treat depression).
Ma għandux jintuża f’ pazjenti b’ mard gravi tal- fwied jew li qed jieħdu waħda minn dawn il- mediċini li ġejjin:  astemizole, terfenadina (terfenadine) (użati komunement għat- trattament tas- sintomi allerġiċi - dawn il- mediċini jistgħu jkunu disponibbli mingħajr riċetta tat- tabib);  diidroergotamina (dihydroergotamine), ergotamina (ergotamine), ergonovina (ergonovine) u metilergonovina (methylergonovine) (użati fit- trattament tal- emikranja);  midazolam, triazolam (użati biex itaffu l- ansjetà jew diffikultà fl- irqad),  pimozide (użat għat- trattament ta ’ mard mentali); 2/ 3  cisapride (użat biex itaffi ċerti problemi tal- istonku);  bepridil (użat għat- trattament tal- anġina);  fexfiex tar- raba ’ (St John’ s wort) (preparazzjoni tal- ħxejjex użata fit- trattament tad- depressjoni).
Caution is also needed when Sustiva is taken at the same time as other medicines.
Meta Sustiva jingħata fl- istess ħin ma ’ mediċini oħra hija meħtieġa l- kawtela.
As with other anti-HIV medicines, patients taking Sustiva may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Bħal għal mediċini oħra ta ’ kontra l- HIV, il- pazjenti ttrattati b’ Sustiva jista ’ jkollhom riskju ta ’ lipodistrofija (bidliet fid- distribuzzjoni tax- xaħam fid- demm), osteonekrożi (mewt ta ’ tessut tal - għadam) jew sindromu tar- riattivazzjoni immunitarja (sintomi ta ’ infezzjoni kkawżati minn sistema immunitarja li tkun qed tirkupra).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Sustiva.
Il- pazjenti li jkollhom problemi bil- fwied (inklużi infezzjonijiet tal - epatite B jew Ċ) jistgħu jkunu esposti aktar għar- riskju li jiżviluppaw ħsara fil- fwied jekk ittrattati b’ Sustiva.
2/ 3 Why has Sustiva been approved?
Għaliex ġie approvat Sustiva?
The Committee for Medicinal Products for Human Use (CHMP) decided that Sustiva’ s benefits are greater than its risks in antiviral combination treatment of HIV-infected adults, adolescents and children three years of age and older.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Sustiva huma ogħla mir- riskji tiegħu fit- trattament antivirali kkombinat ta ’ adulti, adolexxenti u tfal ta ’ età ‘ l fuq minn tliet snin b’ infezzjoni mill- HIV.
The Committee noted that Sustiva has not been studied adequately in patients with advanced disease (CD4 cell counts below 50 cells/ mm3) or after treatment with protease inhibitors (another type of antiviral medicine) that was not working.
Il- Kumitat innota li Sustiva ma ġiex studjat biżżejjed fil- pazjenti f’ fażi avvanzata tal- marda (b’ għadd ta ’ ċelloli CD4 inqas minn 50 ċellola/ mm3) jew li fihom, it- trattament b’ inibituri tal- proteażi (tip ta ’ mediċina antivirali oħra) ma ħadimx.
The Committee also noted that there is little information on the benefits of treatment including a protease inhibitor in patients who have been treated with Sustiva in the past but which stopped working, although there is no evidence to suggest that protease inhibitors may not work in these patients.
Il - Kumitat innota wkoll li l- informazzjoni attwalment disponibbli mhijex biżżejjed biex tivvaluta l - benefiċċji ta ’ trattamenti li jinkludu inibitur tal- proteażi użati wara l- falliment ta ’ terapija b’ Sustiva, minkejja li ma hemmx provi biex isostnu li f’ dawn il- pazjenti l- inibituri tal- proteażi mhumiex effikaċi.
The Committee recommended that Sustiva be given marketing authorisation.
Il- Kumitat irrakkomanda li Sustiva jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Sustiva:
Aktar tagħrif dwar Sustiva:
The European Commission granted a marketing authorisation valid throughout the European Union for Sustiva on 28 May 1999.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Sustiva fit- 28 ta ’ Mejju 1999.
The marketing authorisation holder is Bristol-Myers Squibb Pharma EEIG.
Id- deterntur tal- awtorizzazzjoni għat- tqegħid fis- suq huwa Bristol - Myers Squibb Pharma EEIG.
The marketing authorisation was renewed on 28 May 2004 and on 28 May 2009.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 28 ta ’ Mejju 2009.
The full EPAR for Sustiva can be found here.
L- EPAR sħiħ għal Sustiva jista ’ jiġi kkonsultat hawn.
SUSTIVA 50 mg hard capsules
SUSTIVA 50 mg kapsuli ibsin
Dark yellow and white, printed with "SUSTIVA" on the dark yellow cap and "50 mg" on the white body.
Isfar skur u abjad, stampat b ’ “ SUSTIVA ” fuq il- parti ta ’ lewn isfar skur u "50 mg ” fuq il- parti l- bajda.
SUSTIVA is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older.
4. 1 Indikazzjonijiet terapewtiċi
SUSTIVA has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/ mm3, or after failure of protease inhibitor (PI) containing regimens.
SUSTIVA ma ġiex studjat b’ mod adegwat f’ pazjenti b’ mard avvanzat ta ’ l- HIV, u speċifikament pazjenti b’ għadd CD4 < 50 ċellula/ mm3, jew wara li jkunu fallew kuri li jkun fihom l- impeditur ta ’ protease (PI).
Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI based combination therapy after failure of regimens containing SUSTIVA.
Ghalkemm ir- reżistenza msallba ta ’ efavirenz ma ’ PIs ma ġietx dokumentata, fil- preżent m’ hemmx biżżejjed tagħrif dwar l- effikaċja ta ’ l- użu tal- kura kombinata bbażata fuq PI wara li jkunu fallew il- kuri li fihom SUSTIVA.
SUSTIVA must be given in combination with other antiretroviral medicines (see section 4.5).
SUSTIVA irid jingħata flimkien ma ’ mediċini oħra antiretrovirali (ara sezzjoni 4. 5).
It is recommended that SUSTIVA be taken on an empty stomach.
Huwa rakkomandat li SUSTIVA jittieħed fuq stonku vojt.
The increased efavirenz concentrations observed following administration of SUSTIVA with food may lead to an increase in frequency of adverse reactions (see sections 4.4. and 5.2).
(ara sezzjonijiet 4. 4 u 5. 2).