qanastek/EMEA-V3 huggingface dataset:
95 Effect of food: the AUC and Cmax of a single 240 mg dose of efavirenz oral solution in uninfected adult volunteers was increased by 30% and 43% respectively, when given with a high-fat meal, relative to fasted conditions.
AUC u Cmax ta ’ doża waħda ta ’ 240 mg ta ’ efavirenz soluzzjoni orali f’ voluntiera mhux infettati żdiedet bi 30% u 43% rispettivament, meta mogħti ma ’ ikla b’ livell għoli ta ’ xaħam, meta mqabbel ma ’ kondizzjonijiet ta ’ sawm.
In HIV-1 infected patients (n = 9) who received efavirenz 200 to 600 mg once daily for at least one month, cerebrospinal fluid concentrations ranged from 0.26 to 1.19% (mean 0.69%) of the corresponding plasma concentration.
F’ pazjenti nfettati bl- HIV- 1 (N = 9) li rċevew efavirenz 200 sa 600 mg darba kuljum għall- inqas għal xahar, il- konċentrazzjonijiet tal- fluwidu ċerebrospinali kienu jvarjaw minn 0. 26 sa 1. 19% (medja 0. 69%) tal- konċentrazzjoni korrospondenti tal- plażma.
Paediatric pharmacokinetics: the equivalent of a 600 mg dose of efavirenz was given as hard capsules (dose adjusted from calculated body size based on weight) to 49 paediatric patients.
49 tifel u tifla pazjent ngħataw l- ekwivalenti ta ’ doża ta ’ 600 mg ta ’ efavirenz f’ kapsuli ibsin (doża rranġata mid- daqs ikkalkulat tal- ġisem ibbażat fuq il- piż).
Steady state Cmax was 14.1 μ M, steady state Cmin was 5.6 μ M, and AUC was 216 μ M·h.
Cmax fiss kien ta ’ 14. 1 μM, Cmin fiss kien ta ’ 5. 6 μM, u AUC kien ta ’ 216 μM· h.
In 17 paediatric patients receiving an investigational oral solution similar to the commercial formulation adjusted on the basis of body size to be equivalent to an adult 600 mg capsule dose, the steady-state Cmax was 11.8 μ M, steady state Cmin was 5.2 μ M, and AUC was 188 μ M·h.
Fi 17- il tifel u tifla pazjent li jirċievu soluzzjoni orlai bi prova simili għall- formulazzjoni kummerċjali rranġata skond id- daqs tal- ġisem biex tkun ekwivalenti għal doża adulta ta ’ 600 mg f’ kapsula, Cmax fiss kien ta ’ 11. 8 μM, Cmin fiss kien ta ’ 5. 2 μM, u AUC kien ta ’ 188 μM· h.
In the subset of 6 children aged 3 – 5 who were compliant with their drug regimen, the mean AUC was 147 μ M·h, which was 23% lower than expected.
Fi grupp ta ’ sitta minn dawn it- tfal li kellhom bejn 3 u 5 snin u li kienu qed jieħdu l- kura b’ mod regolari, il- medja ta ’ AUC kienet ta ’ 147 μM· h, li kien 23% inqas milli mistenni.
Therefore, the dosage recommendation provided in Table 1 incorporates a higher dose of efavirenz oral solution for these younger children.
Għalhekk, ir- rakkomandazzjoni tad- doża pprovduta f’ Tabella 1 tinkorpora doża ogħla ta ’ efevirenz soluzzjoni orali għal dan it- tfal li huma iżgħar.
Gender, race, elderly:
Ġendru, razza, anzjani:
Efavirenz induced foetal resorptions in rats.
103 Efavirenz wassal biex il- firien jirriassorbixxu l- feti tagħhom.
Anencephaly and unilateral anophthalmia
Ġew osservati malformazzjonijiet fi 3 minn 20 fetu / mwieled frisk minn xadini cynomolgus ikkurati b’ efavirenz li ngħataw dożi li rriżultaw f’ konċentrazzjonijiet ta ’ efavirenz fil- plażma li kienu simili għal dawk li ġew osservati fil - bnedmin.
96 with secondary enlargement of the tongue were observed in one foetus, microophthalmia was observed in another foetus, and cleft palate was observed in a third foetus.
F’ fetu wieħed kienu osservati anenċefalija u anoftalmija unilaterali bi tkabbir sekondarju ta ’ l- ilsien, f’ fetu ieħor kienet osservata mikro- oftalmija u fit- tielet fetu kienet osservata qasma fis- saqaf tal- ħalq.
Medium chain triglycerides Benzoic acid (E210) Strawberry/ mint flavour
Medium chain triglycerides benzoic acid (E210) togħma ta ’ frawli/ menta.
1 month.
Wara li jinfetaħ l- ewwel darba: xahar.
HDPE bottles with a child-resistant polypropylene closure containing 180 ml of oral solution.
Il- fliexken fihom 180 ml ta ’ soluzzjoni orali.
An oral syringe with a push-in bottle-neck adapter is included in the carton.
Fil- kartuna hemm inkluża wkoll siringa orali b’ adapter ma ’ għonq il- flixkun li tinbuttah ‘ il ġewwa.
97 7.
104 7.
EU/ 1/ 99/ 111/ 005 - bottle
EU/ 1/ 99/ 111/ 005 - flixkun
98 1.
105 1.
STOCRIN 600 mg film-coated tablets
STOCRIN 600 mg pilloli miksija b’ rita
Each film-coated tablet contains 600 mg of efavirenz.
Kull pillola miksija b’ rita fiha 600 mg ta ’ efavirenz
Excipient: each film-coated tablet contains 249.6 mg of lactose monohydrate.
Sustanza mhux attiva: kull kapsula iebsa fiha 249. 6 mg ta ’ lactose monohydrate.
Dark yellow, capsule-shaped, debossed with “ 225 ” on one side.
Sofor skuri, forma ta ’ kapsuli, stampati fil- fond b ’ ” 225 ” fuq naħa waħda.
STOCRIN tablets must only be administered to children who are able to reliably swallow tablets.
Il- pinnoli ta ’ STOCRIN għandhom jingħataw biss lit- tfal li żgur jistgħu jibilgħu l- pilloli.
STOCRIN is not
STOCRIN mhux rakkomandat għal
99 recommended for use in children below the age of 3 years or weighing less than 13 kg due to a lack of data on safety and efficacy in that age group (see sections 5.1 and 5.2).
106 tfal taħt l- eta` tat- 3 snin jew li jiżnu inqas minn 13- il kg minħabba n- nuqqas ta ’ tagħrif dwar is- sigurtà u l- effikaċja f’ dan il- grupp (ara sezzjonijiet 5. 1 u 5. 2).
Table 1 Paediatric dose to be administered once daily
Tabella 1 Doża għat- tfal li tingħata darba kuljum
STOCRIN Dose (mg )∗ 200 250 300 350 400 600
STOCRIN Doża (mg) 200 250 300 350 400 600
∗ STOCRIN 50 mg, 200 mg and 600 mg film-coated tablets are available.
∗ Għal dawn il- pazjenti hemm pilloli STOCRIN miksija b’ rita tal- 50 mg, 200 mg u 600 mg.
If STOCRIN is coadministered with rifampicin, an increase in the dose of STOCRIN to 800 mg/ day may be considered (see section 4.5).
Jekk STOCRIN jingħata flimkien ma ’ rifampicin, tista ’ tiġi kkunsidrata żieda fid- doża ta ’ STOCRIN trid tiżdied għal 800 mg/ kuljum (ara sezzjoni 4. 5).
100 4.4 Special warnings and precautions for use
107 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Patients should be informed that if they do occur, these common symptoms are likely to improve with continued therapy and are not predictive of subsequent onset of any of the less frequent psychiatric symptoms.
Il- pazjenti għandhom ikunu nfurmati li jekk iseħħu, dawn is- sintomi
101 Seizures: convulsions have been observed in patients receiving efavirenz, generally in the presence of known medical history of seizures.
Ġew osservati konvulżjonijiet f’ pazjenti li kienu qed jieħdu efavirenz, ġeneralment meta diġà kien hemm storja medika ta ’ aċċessjonijiet.
Effect of food: the administration of STOCRIN with food may increase efavirenz exposure (see section 5.2) and may lead to an increase in the frequency of adverse reactions (see section 4.8).
Effett ta ’ l- ikel: l- għoti ta ’ STOCRIN ma ’ l- ikel jista ’ jkabbar l- esponiment għal efavirenz (ara sezzjoni 5. 2) u jista ’ jwassal għal żieda fil- frekwenza tar- reazzjonijiet avversi (ara sezzjoni 4. 8).
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Eżempji relevanti huma retinite tas- sitomegalovirus, infezzjonijiet mikobatteriċi ġeneralizzati u/ jew fokali, u pulmonite kkawżata minn Pneumocystis jiroveci (li qabel kien magħruf bħala Pneumocystis carinii).
102 In patients treated with other medicinal products associated with liver toxicity, monitoring of liver enzymes is also recommended.
F’ pazjenti kkurati bi prodotti mediċinali oħra marbuta ma ’ tossiċita` fil- fwied, huwa rakkomandat li jkun hemm monitoraġġ ta ’ l- enzimi tal- fwied.
103 Table 2:
110 Tabella 2:
105 Medicinal product by therapeutic
112 Prodott mediċinali skond l- oqsma terapewtiċi (doża)
106 Medicinal product by therapeutic
113 Prodott mediċinali skond l- oqsma terapewtiċi (doża) NRTIs u NNRTIs
109 Medicinal product by therapeutic
Inibituri Selettivi tat- Teħid mill- ġdid Sertraline/ Efavirenz
110 Medicinal product by therapeutic
Verapamil, Felodipine, Nifedipine u Ma ġietx studjata l- interazzjoni.
Recommendation concerning
118 Prodott mediċinali skond l- oqsma
Rosuvastatin/ Efavirenz
119 Prodott mediċinali skond l- oqsma terapewtiċi (doża)
112 Women of childbearing potential: pregnancy should be avoided in women treated with efavirenz.
Nisa li jistgħu jinqabdu tqal: nisa li qed jieħdu efavirenz m’ għandhomx joħorġu tqal.
Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machinery.
Il- pazjenti għandhom jingħataw istruzzjonijiet li jekk ikollhom dawn is- sintomi għandhom jevitaw attivita` li tista ’ tkun perikoluża bħal sewqan u t- tħaddim ta ’ makkinarju.
The administration of STOCRIN with food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see section 4.4).
L- għoti ta ’ 121 STOCRIN ma ’ l- ikel jista ’ jkabbar l- esponiment għal efavirenz u jista ’ jwassal għal żieda fil - frekwenza tar- reazzjonijiet avversi (ara sezzjoni 4. 4).
113 Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited.
L- esperjenza ta ’ efavirenz f’ pazjenti li ma komplewx jieħdu aġenti antiretrovirali oħra tal- klassi NNRTI hija limitata.
Efavirenz regimen
- depressjoni severa - ideat suwiċidali - attentati mhux fatali ta ’ suwiċidju - mġieba aggressiva - reazzjonijiet paranojdi - reazzjonijiet manijaċi
Control regimen
Kura
In one clinical study, the monthly prevalence of nervous system symptoms of at least moderate severity between weeks 4 and 48, ranged from 5% - 9% in patients treated with regimens containing efavirenz and 3% - 5% in patients treated with the control regimen.
122 sa 9% f’ pazjenti li kellhom kura li kien fiha efavirenz u minn 3% sa 5% f’ pazjenti li kellhom kura ta ’ kontroll.
114 Nervous system disorders common
Disturbi fis- sistema nervuża komuni
Immune system disorders uncommon
Disturbi fis- sistema immuni
hypersensitivity
mhux komuni
Hepatobiliary disorders
sensittività eċċessiva
uncommon
123 Disturbi fil- fwied u fil- marrara mhux komuni
Reproductive system and breast disorders uncommon
Disturbi fis- sistema riproduttiva u fis- sider
gynaecomastia
mhux komuni
Psychiatric disorders
ginekomastja
common
Disturbi psikjatriċi komuni
115 Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
It- terapija antiretrovirali kombinata ġiet marbuta ma ’ anormalitajiet metaboliċi bħall - ipertriglajseridemija, iperkolesterolemija, reżistenza għall- insulina, ipergliċemija u iperlaktatemija (ara sezzjoni 4. 4).
116 Paediatric patients: undesirable effects in children were generally similar to those of adult patients.
Pazjenti pedjatriċi: l- effetti mhux mixtieqa fit- tfal kienu ġeneralment simili għal dawk tal- pazjenti adulti.
Long-term results at 168 weeks of study 006 (160 patients completed study on treatment with EFV +IDV, 196 patients with EFV + ZDV + 3TC and 127 patients with IDV + ZDV + 3TC, respectively), suggest durability of response in terms of proportions of patients with HIV RNA < 400 copies/ ml, HIV RNA < 50 copies/ ml and in terms of mean change from baseline CD4 cell count.
Riżultati fit- tul mal- 168 ġimgħa ta ’ l- istudju 006 (160 pazjent spiċċaw l- istudju bil- kura b’ EFV +IDV, 196 pazjent b’ EFV + ZDV + 3TC u 127 pazjent b’ IDV + ZDV + 3TC, rispettivament), jissuġġerixxu li r- rispons ta ’ jisfaxxax fix- xejn, fis- sens tal- proporzjoni ta ’ pazenti b’ HIV RNA < 400 kopji/ ml, HIV RNA < 50 kopji/ ml u fis- sens tal- bidla medja mil- linja bażi CD4 ta ’ l- għadd taċ- ċelluli.
Study Number/ Treatment Regimensb
Numru ta ’ l- istudju / Tipi ta ’ Kurab
Dose related increases in Cmax and AUC were seen for doses up to 1,600 mg; the increases were less than proportional
Ġew osservati żidiet f’ Cmax u AUC marbuta mad- dożi għal dożi sa 1, 600 mg; iż- żidiet kienu inqas minn proporzjonali li kien jindika li kien hemm inqas assorbiment ma ’ dożi ogħla.
Effect of food: the AUC and Cmax of a single 600 mg dose of efavirenz film-coated tablets in uninfected volunteers was increased by 28% (90% CI:
AUC u Cmax ta ’ doża waħda ta ’ 600 mg ta ’ pilloli miksija b’ rita ta ’ efavirenz f’ voluntiera mhux infettati żdiedu bi 28% (90% CI:
22 – 33%) and 79% (90% CI:58 – 102%), respectively, when given with a high fat meal relative to when given under fasted conditions (see section 4.4).
22 – 33%) u 79% (90% CI: 58 – 102%), rispettivament, meta ngħataw ikla b’ ħafna xaħam meta mqabble ma ’ meta kienu f’ kondizzjonijiet ta ’ sawm (ara sezzjoni 4. 4).
Biotransformation: studies in humans and in vitro studies using human liver microsomes have demonstrated that efavirenz is principally metabolised by the cytochrome P450 system to hydroxylated metabolites with subsequent glucuronidation of these hydroxylated metabolites.
Biotrasformazzjoni: studji fil- bnedmin u studji in vitro bil- mikrosomi tal- fwied uman urew li efavirenz l- iktar li jkun metabolizzat bis- sistema cytochrome P450 f’ metaboliti idrossilati li wara jgħaddu minn proċess ta ’ glukuronidazzjoni.
The in vitro studies suggest that CYP3A4 and CYP2B6 are the major isozymes responsible for efavirenz metabolism and that it inhibited P450 isozymes 2C9, 2C19, and 3A4.
Studji in vitro jissuġġerixxu li CYP3A4 u CYP2B6 huma l- iżozimi li l- iktar huma responsabbli għall - metaboliżmu ta ’ efavirenz u li hu impedixxa iżozimi P450 2C9, 2C19, and 3A4.
The clinical implications of such an association are unknown; however, the potential for an increased frequency and severity of efavirenz-associated adverse events cannot be excluded.
128 magħrufa; madankollu, il- potenzjal għal frekwenza u severità akbar ta ’ l- episodji avversi assoċjati ma ’ efavirenz ma jistax jiġi eskluż.
Elimination: efavirenz has a relatively long terminal half-life of at least 52 hours after single doses and 40 - 55 hours after multiple doses.
Tneħħija: efavirenz għandu half- life terminali relattivament twil ta ’ mill- anqas 52 siegħa wara dożi waħedhom u minn 40 sa 55 siegħa wara dożi multipli.
Gender, race, elderly: although limited data suggest that females as well as Asian and Pacific Island patients may have higher exposure to efavirenz, they do not appear to be less tolerant of efavirenz.
Għalkemm it- tagħrif limitat jissuġġerixxi li n- nisa kif ukoll pazjenti Ażjatiċi u mill- Gżejjer tal- Paċifiku jista ’ jkunu esposti iktar għal efavirenz, ma jidhrux li huma inqas tolleranti għal efavirenz.
120 5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Tablet core Croscarmellose sodium Microcrystalline cellulose Sodium laurilsulfate Hydroxypropylcellulose Lactose monohydrate Magnesium stearate
Qalba tal- pillola Croscarmellose sodium Microcrystalline cellulose Sodium laurilsulfate Hydroxypropylcellulose Lactose monohydrate Magnesium stearate.
Film coating Hypromellose (E464) Titanium dioxide (E171) Macrogol 400 Yellow iron oxide (E172) Carnauba wax
Kisja tar- rita Hypromellose (E464) Titanium dioxide (E171) Macrogol 400 Iron oxide isfar (E172) Xama ’ tal- carnauba.
6.2 Incompatibilities
. 6. 2 Inkompatibilitajiet
2 years.
sentejn.
121 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Each carton contains 1 bottle of 30 film-coated tablets.
Kull kartuna fiha flixkun wieħed ta ’ 30 pillola miksija.
Packs of 30 x 1 film-coated tablets in aluminium perforated unit dose blisters.
Pakketti ta ’ 30 x 1 pillola miksija b’ rita f’ folji ta ’ l- aluminju mtaqqba għal dożi singoli.
EU/ 1/ 99/ 111/ 008 – bottle EU/ 1/ 99/ 111/ 009 – blister
EU/ 1/ 99/ 111/ 008 - flixkun EU/ 1/ 99/ 111/ 009 - folja
122 1.
131 1.
STOCRIN 50 mg film-coated tablets
STOCRIN 50 mg pilloli miksija b’ rita
Each film-coated tablet contains 50 mg of efavirenz.
Kull pillola miksija b’ rita fiha 50 mg ta ’ efavirenz
Excipient: each film-coated tablet contains 20.8 mg of lactose monohydrate.
Sustanza mhux attiva: kull kapsula iebsa fiha 20. 8 mg ta ’ lactose monohydrate.
Yellow, round, debossed with “ 113 ” on one side.
Sofor skuri, tondi, stampati fil- fond b ’ ” 113 ” fuq naħa waħda.
123 recommended for use in children below the age of 3 years or weighing less than 13 kg due to a lack of data on safety and efficacy in that age group (see sections 5.1 and 5.2).
132 tfal taħt l- eta` tat- 3 snin jew li jiżnu inqas minn 13- il kg minħabba n- nuqqas ta ’ tagħrif dwar is- sigurtà u l- effikaċja f’ dan il- grupp (ara sezzjonijiet 5. 1 u 5. 2).
Patients should be monitored carefully for dose-related adversereactions, especially nervous system symptoms (see sections 4.3 and 4.4).
Il- pazjenti jridu jkunu monitorjati b’ attenzjoni għal reazzjonijiet avversi marbuta mad- doża, speċjalment sintomi tas- sistema nervuża (ara sezzjonijiet 4. 3 u 4. 4).
124 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
125 Seizures: convulsions have been observed in patients receiving efavirenz, generally in the presence of known medical history of seizures.
Ġew osservati konvulżjonijiet f’ pazjenti li kienu qed jieħdu efavirenz, ġeneralment meta diġà kien hemm storja medika ta ’ aċċessjonijiet.
Patients who are receiving concomitant anticonvulsant medicinal products primarily metabolised by the liver, such as phenytoin, carbamazepine and phenobarbital, may require periodic monitoring of plasma levels.
134 u phenobarbital, jista ’ jkun hemm bżonn li l- livelli tagħhom fil- plażma jkun monitorjat.
126 In patients treated with other medicinal products associated with liver toxicity, monitoring of liver enzymes is also recommended.
F’ pazjenti kkurati bi prodotti mediċinali oħra marbuta ma ’ tossiċita` fil- fwied, huwa rakkomandat li jkun hemm monitoraġġ ta ’ l- enzimi tal- fwied.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
135 ħin għall- epatite B u C, jekk jogħġbok irreferi wkoll għall- informazzjoni relevanti dwar il- prodott għal dawn il- prodotti mediċinali.
Efavirenz is an inducer of CYP3A4 and an inhibitor of some CYP450 isoenzymes including CYP3A4 (see section 5.2).
Efavirenz jinduċi CYP3A4 u huwa impeditur ta ’ xi xi isoenzimi CYP450 fosthom CYP3A4 (ara sezzjoni 5. 2).
Other compounds that are substrates of CYP3A4 may have decreased plasma concentrations when co-administered with efavirenz.
Komposti oħra li huma substrati ta ’ CYP3A4 jista ’ jkollhom konċentrazzjonijiet imnaqqsa tal- plażma meta jingħataw flimkien ma ’ efavirenz.
127 Table 2:
136 Tabella 2:
(CYP3A4 induction) Efavirenz:
AUC: ↓ 31% (↓ 8 għal ↓ 47) Cmin: ↓ 40% Tnaqqis simili fl- espożizzjonijiet għal indinavir ġew osservati meta indinavir 1. 000 mg q8h ingħata
128 Medicinal product by therapeutic
Indinavir/ Efavirenz (1, 000 mg q8h/ 600 mg darba kuljum)
Effects on drug levels
flimkien ma ’ efavirenz 600 mg kuljum Efavirenz:
Recommendation concerning
Ebda interazzjoni farmakokinetika klinikament sinifikanti
percent change in AUC,
wieħed jagħżel trattament li jkun fih kemm efavirenz kif ukoll indinavir.
co-administration with
Indinavir/ Ritonavir/ Efavirenz (800 mg darbtejn kuljum/ 100 mg
(dose)
Indinavir:
Cmax, Cmin with confidence intervals if availablea (mechanism)
AUC: ↓ 25% (↓ 16 għal ↓ 32) b
efavirenz
Ara wkoll ir- ringiela dwar ritonavir
Indinavir/ ritonavir/ Efavirenz (800 mg twice daily/ 100 mg twice daily/ 600 mg once daily)
darbtejn kuljum/ 600 mg darba kuljum)
indinavir/ ritonavir.
hawn isfel.
129 Medicinal product by therapeutic
138 Prodott mediċinali skond l- oqsma terapewtiċi (doża)
130 Medicinal product by therapeutic
139 Prodott mediċinali skond l- oqsma terapewtiċi (doża) NRTIs u NNRTIs
AUC: ↑ 44% Cmax: ↑ 38% Voriconazole:
AUC: ↑ 44% Cmax: ↑ 38% Voriconazole:
When efavirenz is co-administered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg twice daily and the efavirenz dose must be reduced by 50%, i. e., to 300 mg
Meta efavirenz jingħata fl- istess ħin ma ’ voriconazole, id- doża ta ’ manteniment ta ’ voriconazole għandha tiżdied għal 400 mg darbtejn kuljum u d- doża ta ’ efavirenz għandha titnaqqas b’ 50%, jiġifieri għal 300 mg darba kuljum.
once daily.
tiddaħħal id- doża inizjali ta ’ efavirenz.
133 Medicinal product by therapeutic
Inibituri Selettivi tat- Teħid mill- ġdid Sertraline/ Efavirenz
134 Medicinal product by therapeutic
Verapamil, Felodipine, Nifedipine u Ma ġietx studjata l- interazzjoni.
Recommendation concerning
144 Prodott mediċinali skond l- oqsma
Rosuvastatin/ Efavirenz
145 Prodott mediċinali skond l- oqsma terapewtiċi (doża)
Dose adjustment of buprenorphine or efavirenz may not be necessary when co- administered.
Jista ’ ma jkunx hemm bżonn ta ’ aġġustament fid - doża ta ’ buprenorphine meta mogħti flimkien ma ’ sustanza oħra.
136 Women of childbearing potential: pregnancy should be avoided in women treated with efavirenz.
Nisa li jistgħu jinqabdu tqal: nisa li qed jieħdu efavirenz m’ għandhomx joħorġu tqal.
The administration of STOCRIN with food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see section 4.4).
L- għoti ta ’ 147 STOCRIN ma ’ l- ikel jista ’ jkabbar l- esponiment għal efavirenz u jista ’ jwassal għal żieda fil - frekwenza tar- reazzjonijiet avversi (ara sezzjoni 4. 4).
137 Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited.
L- esperjenza ta ’ efavirenz f’ pazjenti li ma komplewx jieħdu aġenti antiretrovirali oħra tal- klassi NNRTI hija limitata.
In one clinical study, the monthly prevalence of nervous system symptoms of at least moderate severity between weeks 4 and 48, ranged from 5% - 9% in patients treated with regimens containing efavirenz and 3% - 5% in patients treated with the control regimen.
148 sa 9% f’ pazjenti li kellhom kura li kien fiha efavirenz u minn 3% sa 5% f’ pazjenti li kellhom kura ta ’ kontroll.
138 Nervous system disorders common
Disturbi fis- sistema nervuża komuni
uncommon
149 Disturbi fil- fwied u fil- marrara mhux komuni
139 Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
It- terapija antiretrovirali kombinata ġiet marbuta ma ’ anormalitajiet metaboliċi bħall - ipertriglajseridemija, iperkolesterolemija, reżistenza għall- insulina, ipergliċemija u iperlaktatemija (ara sezzjoni 4. 4).
140 Paediatric patients: undesirable effects in children were generally similar to those of adult patients.
Pazjenti pedjatriċi: l- effetti mhux mixtieqa fit- tfal kienu ġeneralment simili għal dawk tal- pazjenti adulti.
Long-term results at 168 weeks of study 006 (160 patients completed study on treatment with EFV +IDV, 196 patients with EFV + ZDV + 3TC and 127 patients with IDV + ZDV + 3TC, respectively), suggest durability of response in terms of proportions of patients with HIV-RNA < 400 copies/ ml, HIV-RNA < 50 copies/ ml and in terms of mean change from baseline CD4 cell count.
Riżultati fit- tul mal- 168 ġimgħa ta ’ l- istudju 006 (160 pazjent spiċċaw l- istudju bil- kura b’ EFV +IDV, 196 pazjent b’ EFV + ZDV + 3TC u 127 pazjent b’ IDV + ZDV + 3TC, rispettivament), jissuġġerixxu li r- rispons ta ’ jisfaxxax fix- xejn, fis- sens tal- proporzjoni ta ’ pazenti b’ HIV RNA < 400 kopji/ ml, HIV RNA < 50 kopji/ ml u fis- sens tal- bidla medja mil- linja bażi CD4 ta ’ l- għadd taċ- ċelluli.
Table 4:
153 Tabella 4:
143 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Distribution: efavirenz is highly bound (approximately 99.5 - 99.75%) to human plasma proteins, predominantly albumin.
154 Distribuzzjoni: efavirenz jintabat ħafna (bejn wieħed u ieħor 99. 5 – 99. 75%) mal- proteini tal- plażma umana, speċjalment albumin.
In uninfected volunteers, multiple doses of 200 - 400 mg per day for 10 days resulted in a lower than predicted extent of accumulation (22 - 42% lower) and a shorter terminal half-life compared with single dose administration (see below).
F’ voluntiera mhux infettati, dożi multipli ta ’ 200 – 400 mg kuljum għal 10 ijiem irriżulta f’ akkumulu li kien iktar baxx minn dak imbassar (22 - 42% iktar baxx) u half- life terminali iqsar meta mqabbel ma ’ l- għoti ta ’ doża waħda (ara taħt)
144 Gender, race, elderly: although limited data suggest that females as well as Asian and Pacific Island patients may have higher exposure to efavirenz, they do not appear to be less tolerant of efavirenz.
Għalkemm it- tagħrif limitat jissuġġerixxi li n- nisa kif ukoll pazjenti Ażjatiċi u mill- Gżejjer tal- Paċifiku jista ’ jkunu esposti iktar għal efavirenz, ma jidhrux li huma inqas tolleranti għal efavirenz.
145 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
EU/ 1/ 99/ 111/ 010 - bottle
EU/ 1/ 99/ 111/ 010 - flixkun
28 May 1999.
28 ta ’ Mejju 1999.
146 1.
157 1.
STOCRIN 200 mg film-coated tablets
STOCRIN 200 mg pilloli miksija b’ rita
Each film-coated tablet contains 200 mg of efavirenz.
Kull pillola miksija b’ rita fiha 200 mg ta ’ efavirenz
Excipient: each film-coated tablet contains 83.2 mg of lactose monohydrate.
Sustanza mhux attiva: kull kapsula iebsa fiha 83. 2 mg ta ’ lactose monohydrate.
Yellow, round, debossed with “ 223 ” on one side.
Sofor skuri, tondi, stampati fil- fond b ’ ” 223 ” fuq naħa waħda.
147 recommended for use in children below the age of 3 years or weighing less than 13 kg due to a lack of data on safety and efficacy in that age group (see sections 5.1 and 5.2).
158 tfal taħt l- eta` tat- 3 snin jew li jiżnu inqas minn 13- il kg minħabba n- nuqqas ta ’ tagħrif dwar is- sigurtà u l- effikaċja f’ dan il- grupp (ara sezzjonijiet 5. 1 u 5. 2).
148 4.4 Special warnings and precautions for use
159 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
149 Seizures: convulsions have been observed in patients receiving efavirenz, generally in the presence of known medical history of seizures.
Ġew osservati konvulżjonijiet f’ pazjenti li kienu qed jieħdu efavirenz, ġeneralment meta diġà kien hemm storja medika ta ’ aċċessjonijiet.
Immune Reactivation Syndrome: in HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Sindromu tar- Rijattivazzjoni Immunitarja: f’ pazjenti infettati bl- HIV b’ defiċjenza immunitarja qawwija meta jibdew jieħdu terapija kombinata antiretrovirali (CART), jista ’ jkun hemm reazzjoni infjammatorja għal patoġeni asintomatiċi jew residwi opportunistiċi u tista ’ tikkawża condizzjonijiet kliniċi serji, jew sintomi li jiħraxu.
150 In patients treated with other medicinal products associated with liver toxicity, monitoring of liver enzymes is also recommended.
161 F’ pazjenti kkurati bi prodotti mediċinali oħra marbuta ma ’ tossiċita` fil- fwied, huwa rakkomandat li jkun hemm monitoraġġ ta ’ l- enzimi tal- fwied.
151 Table 2:
162 Tabella 2:
152 Medicinal product by therapeutic
Indinavir/ Efavirenz (1, 000 mg q8h/ 600 mg darba kuljum)
153 Medicinal product by therapeutic
164 Prodott mediċinali skond l- oqsma terapewtiċi (doża)
154 Medicinal product by therapeutic
165 Prodott mediċinali skond l- oqsma terapewtiċi (doża) NRTIs u NNRTIs
157 Medicinal product by therapeutic
Inibituri Selettivi tat- Teħid mill- ġdid Sertraline/ Efavirenz
158 Medicinal product by therapeutic
Verapamil, Felodipine, Nifedipine u Ma ġietx studjata l- interazzjoni.
Recommendation concerning
170 Prodott mediċinali skond l- oqsma
Rosuvastatin/ Efavirenz
171 Prodott mediċinali skond l- oqsma terapewtiċi (doża)
160 Women of childbearing potential: pregnancy should be avoided in women treated with efavirenz.
Nisa li jistgħu jinqabdu tqal: nisa li qed jieħdu efavirenz m’ għandhomx joħorġu tqal.
The administration of STOCRIN with food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see section 4.4).
Ir- reazzjonijiet avversi marbuta ma ’ efavirenz li kienu l- iktar prominenti kienu raxx u sintomi tas- sistema nervuża L- għoti ta ’ 173 STOCRIN ma ’ l- ikel jista ’ jkabbar l- esponiment għal efavirenz u jista ’ jwassal għal żieda fil - frekwenza tar- reazzjonijiet avversi (ara sezzjoni 4. 4).
Skin rash was considered treatment related in 18% of patients treated with efavirenz.
Ir- raxx fil- ġilda tqies li kien marbut mal - kura fi 18% tal- pazjenti kkurati b’ efavirenz.
161 Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited.
L- esperjenza ta ’ efavirenz f’ pazjenti li ma komplewx jieħdu aġenti antiretrovirali oħra tal- klassi NNRTI hija limitata.
In one clinical study, the monthly prevalence of nervous system symptoms of at least moderate severity between weeks 4 and 48, ranged from 5% - 9% in patients treated with regimens containing efavirenz and 3% - 5% in patients treated with the control regimen.
174 sa 9% f’ pazjenti li kellhom kura li kien fiha efavirenz u minn 3% sa 5% f’ pazjenti li kellhom kura ta ’ kontroll.
162 Nervous system disorders common
Disturbi fis- sistema nervuża komuni
uncommon
175 Disturbi fil- fwied u fil- marrara mhux komuni
163 Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
It- terapija antiretrovirali kombinata ġiet marbuta ma ’ anormalitajiet metaboliċi bħall - ipertriglajseridemija, iperkolesterolemija, reżistenza għall- insulina, ipergliċemija u iperlaktatemija (ara sezzjoni 4. 4).
164 Paediatric patients: undesirable effects in children were generally similar to those of adult patients.
Pazjenti pedjatriċi: l- effetti mhux mixtieqa fit- tfal kienu ġeneralment simili għal dawk tal- pazjenti adulti.
Long-term results at 168 weeks of study 006 (160 patients completed study on treatment with EFV +IDV, 196 patients with EFV + ZDV + 3TC and 127 patients with IDV + ZDV + 3TC, respectively), suggest durability of response in terms of proportions of patients with HIV-RNA < 400 copies/ ml, HIV-RNA < 50 copies/ ml and in terms of mean change from baseline CD4 cell count.
Riżultati fit- tul mal- 168 ġimgħa ta ’ l- istudju 006 (160 pazjent spiċċaw l- istudju bil- kura b’ EFV +IDV, 196 pazjent b’ EFV + ZDV + 3TC u 127 pazjent b’ IDV + ZDV + 3TC, rispettivament), jissuġġerixxu li r- rispons ma jisfaxxax fix- xejn, fis- sens tal- proporzjoni ta ’ pazenti b’ HIV RNA < 400 kopji/ ml, HIV RNA < 50 kopji/ ml u fis- sens tal- bidla medja mil- linja bażi CD4 ta ’ l- għadd taċ- ċelluli.
Table 4:
179 Tabella 4:
167 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
22 – 33%) and 79% (90% CI:58 – 102%), respectively, when given with a high fat meal relative to when given under fasted conditions (see section 4.4).
22 – 33%) u 79% (90% CI: 58 – 102%), rispettivament, meta ngħataw ikla b’ ħafna xaħam meta mqabble ma ’ meta kienu f’ kondizzjonijiet ta ’ sawm.
In HIV-1 infected patients (n = 9) who received efavirenz 200 to 600 mg once daily for at least one month, cerebrospinal fluid concentrations ranged from 0.26 to 1.19% (mean 0.69%) of the corresponding plasma concentration.
F’ pazjenti nfettati bl- HIV- 1 (n = 9) li rċevew efavirenz 200 sa 600 mg 180 darba kuljum għall- inqas għal xahar, il- konċentrazzjonijiet tal- fluwidu ċerebrospinali kienu jvarjaw minn 0. 26 sa 1. 19% (medja 0. 69%) tal- konċentrazzjoni korrospondenti tal- plażma.
168 Gender, race, elderly: although limited data suggest that females as well as Asian and Pacific Island patients may have higher exposure to efavirenz, they do not appear to be less tolerant of efavirenz.
Għalkemm it- tagħrif limitat jissuġġerixxi li n- nisa kif ukoll pazjenti Ażjatiċi u mill- Gżejjer tal- Paċifiku jista ’ jkunu esposti iktar għal efavirenz, ma jidhrux li huma inqas tolleranti għal efavirenz.
Non-sustained convulsions were observed in some monkeys receiving efavirenz for ≥ 1 year, at doses yielding plasma AUC values 4- to 13-fold greater than those in humans given the recommended dose (see sections 4.4 and 4.8).
181 efavirenz għal ≥ sena, b’ dożi li kienu jwasslu għal valuri ta ’ AUC fil- plażma bejn 4 u 13- il darba ikbar minn dawk fil- bnedmin li ngħataw id- doża rakkomandata (ara sezzjonijiet 4. 4 u 4. 8).
169 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Each carton contains 1 bottle of 90 film-coated tablets.
Kull kartuna fiha flixkun wieħed ta ’ 90 pillola miksija.
EU/ 1/ 99/ 111/ 011 - bottle
EU/ 1/ 99/ 111/ 011 - flixkun
28 May 1999.
28 ta ’ Mejju 1999
170 ANNEX II
183 ANNESS II
171 A.
184 A.
Waarderweg 39 PO Box 581 2003 PC Haarlem The Netherlands
Waarderweg 39 PO Box 581 2003 PC Haarlem L- Olanda
The MAH must ensure that the system of pharmacovigilance, as described in version 4 (14th April 2008) and included in the Type II variation (EMEA/ H/ C/ 250/ II/ 72) is in place and functioning before and whilst the product is on the market.
Id- detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 4 (14 ta ’ April 2008) u nkluża fil- varjazzjoni Tip II (EMEA/ H/ C/ 250/ II/ 72) tkun fis- seħħ u li din tkun qegħda taħdem qabel u waqt li l- prodott ikun fis- suq.
The Marketing Authorisation Holder will continue to submit annual PSURs.
Id- detentur ta 'din l- awtorizzazzjoni għat- tqegħid fis- suq se jkompli jissottometti PSURs annwali.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq jimpenja ruħu li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali mogħtija fid- dettall fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil - verżjoni 1. 0 tal- Pjan tal- Ġestjoni tar- Riskju (RMP) ippreżentat fis- Sezzjoni 1. 8. 2. tal- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti tal- RMP miftiehem mill - CHMP.
• When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
• Meta tasal informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà attwali, fuq il- Pjan tal- Farmakoviġilanza jew fuq l- attivitajiet ta ’ minimizzazzjoni tar- riskji • Fi żmien 60 jum minn meta tintlaħaq mira importanti (farmakoviġilanza jew minimizzazzjoni tar- riskji)
172 ANNEX III
186 ANNESS III
173 A.
187 A.
174 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
188 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON AND LABEL TEXT FOR BOTTLE PACK
TIKKETTA TAL- FLIXKUN U L- KLIEM TA ’ BARRA TAL- KAXXA GĦALL- PAKK TAL - FLIEXKEN
STOCRIN 50 mg hard capsules efavirenz
STOCRIN 50 mg kapsuli ibsin efavirenz
Each hard capsule contains: efavirenz 50 mg
Kull kapsula iebsa fiha: efavirenz 50 mg
See package leaflet for further information.
Fiha: lactose monohydrate, Għal aktar informazzjoni ara l- fuljettt ta ’ tagħrif..
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel l- użu..
175 10.
189 10.
STOCRIN 50 mg capsules
STOCRIN 50 mg kapsuli
176 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
190 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
STOCRIN 100 mg hard capsules efavirenz
STOCRIN 100 mg kapsuli ibsin efavirenz
Each hard capsule contains: efavirenz 100 mg
Kull kapsula iebsa fiha: efavirenz 100 mg
It contains: lactose monohydrate.
Fiha: lactose monohydrate.
See package leaflet for further information.
Għal aktar informazzjoni ara l- fuljett ta ’ tagħrif.
177 10.
191 10.
STOCRIN 100 mg capsules
STOCRIN 100 mg kapsuli
178 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
192 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON AND LABEL TEXT FOR BOTTLE PACK OUTER CARTON TEXT FOR BLISTER PACK
TIKKETTA TAL- FLIXKUN U L- KLIEM TA ’ BARRA TAL- KAXXA GĦALL- PAKK TAL - FLIEXKEN IL- KLIEM TA ’ BARRA TAL- KAXXA GĦALL- PAKK TAL- FOLJI
STOCRIN 200 mg hard capsules efavirenz
STOCRIN 200 mg kapsuli ibsin efavirenz
Each hard capsule contains: efavirenz 200 mg
Kull kapsula iebsa fiha: efavirenz 200 mg
See package leaflet for further information.
Fiha: lactose monohydrate, Għal aktar informazzjoni ara l- fuljett ta ’ tagħrif.
90 hard capsules: bottle 42 x 1 hard capsules: blister
90 kapsula iebsa: flixkun 42 x 1 kapsula iebsa: folja
179 10.
193 10.
STOCRIN 200 mg capsules
STOCRIN 200 mg kapsuli
180 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
194 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
BLISTER TEXT
KLIEM FUQ IL- FOLJA
STOCRIN 200 mg capsules efavirenz
STOCRIN kapsuli tal- 200 mg efavirenz
181 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
195 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
STOCRIN 30 mg/ ml oral solution efavirenz
STOCRIN 30 mg/ ml soluzzjoni orali efavirenz
Each ml contains: efavirenz 30 mg
30 mg ta ’ efavirenz
180 ml oral solution
180 ml soluzzjoni orali
EXP Use the oral solution within one month after first opening the bottle.
JIS Uża s- soluzzjoni orali fi żmien xahar minn meta jinfetaħ il- flixkun.
182 11.
196 11.
Lot
Lott {numru}
183 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
197 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON AND LABEL TEXT FOR BOTTLE PACK OUTER CARTON TEXT FOR BLISTER PACK
TIKKETTA TAL- FLIXKUN U L- KLIEM TA ’ BARRA TAL- KAXXA GĦALL- PAKK TAL - FLIEXKEN IL- KLIEM TA ’ BARRA TAL- KAXXA GĦALL- PAKK TAL- FOLJA
STOCRIN 600 mg film-coated tablets efavirenz
STOCRIN 600 mg pilloli miksija b’ rita efavirenz
Each film-coated tablet contains: efavirenz 600 mg
Kull pillola miksija b’ rita fiha: efavirenz 600 mg
30 film-coated tablets: bottle 30 x 1 film-coated tablets: blister
30 pillola miksija b’ rita: flixkun 30 x 1 pillola miksija b’ rita: folja
184 10.
198 10.
EU/ 1/ 99/ 111/ 008 – bottle EU/ 1/ 99/ 111/ 009 – blister
EU/ 1/ 99/ 111/ 008 – flixkun EU/ 1/ 99/ 111/ 009 – folja
185 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
199 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
STOCRIN 600 mg tablets efavirenz
STOCRIN pilloli tat- 600 mg efavirenz
186 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
200 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
STOCRIN 50 mg film-coated tablets efavirenz
STOCRIN 50 mg pilloli miksija b’ rita efavirenz
Each film-coated tablet contains: efavirenz 50 mg
50 mg ta ’ efavirenz
See package leaflet for further information.
Kull kapsula iebsaF fiha: lactose monohydrate, Għal aktar informazzjoni ara l- fuljettt ta ’ tagħrif.
187 10.
201 10.
STOCRIN 50 mg tablets
STOCRIN 50 mg pilloli
188 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
202 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
STOCRIN 200 mg film-coated tablets efavirenz
STOCRIN 200 mg pillola miksija b’ rita efavirenz
Each film-coated tablet contains: efavirenz 200 mg
200 mg ta ’ efavirenz
189 10.
203 10.
STOCRIN 200 mg tablets
STOCRIN 200 mg pilloli
190 B.
204 B.
191 PACKAGE LEAFLET:
205 FULJETT TA ’ TAGĦRIF:
STOCRIN 50 mg hard capsules efavirenz
STOCRIN 50 mg kapsula iebsa efavirenz
What STOCRIN is and what it is used for 2.
X’ inhu STOCRIN u għalxiex jintuża 2.
Before you take STOCRIN 3.
Qabel ma tieħu STOCRIN 3.
How to take STOCRIN 4.
Kif għandek tieħu STOCRIN Effetti sekondarji li jista ’ jkollu 4.
How to store STOCRIN 6.
Kif taħżen STOCRIN 6.
WHAT STOCRIN IS AND WHAT IT IS USED FOR
X’ INHU STOCRIN U GĦALXIEX JINTUŻA
STOCRIN belongs to a class of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Stocrin hija parti minn klassi ta ’ drogi antiretrovirali li jissejħu inibituri non- nukleosidi ta ’ reverse transcriptase (NNTRIs).
It is an antiretroviral medicine that fights human immunodeficiency virus (HIV) infection by reducing the amount of the virus in blood.
Hija mediċina antiretrovirali li tissielet infezzjoni bil- virus tal - immunodefiċjenza umana (HIV) billi tnaqqas l- ammont ta ’ virus fid- demm.
Your doctor has prescribed STOCRIN for you because you have HIV infection.
It- tabib tiegħek ordnalek STOCRIN għax għandek l- infezzjoni ta ’ l- HIV.
STOCRIN taken in combination with other antiretroviral medicines reduces the amount of the virus in the blood.
Meta STOCRIN jittieħed flimkien ma ’ mediċini antiretrovirali oħra, inaqqas l- ammont ta ’ virus fid- demm.
BEFORE YOU TAKE STOCRIN
QABEL MA TIEĦU STOCRIN
Do not take STOCRIN • if you are allergic (hypersensitive) to efavirenz or any of the other ingredients of STOCRIN listed at the end of this leaflet.
Tiħux STOCRIN • jekk int allerġiku (tbati minn sensittività eċċessiva) għal efavirenz jew sustanzi oħra ta ’ STOCRIN elenkati fi tmiem dan il- fuljett.
Contact your doctor or pharmacist for advice. • if you have severe liver disease • if you are currently taking any of the following medicines:
Ikkuntattja lit- tabib jew lill- ispiżjar tiegħek għal parir. • jekk għandek mard tal- fwied sever • jekk bħalissa qed tieħu xi waħda minn dawn il- mediċini:
- - - -
- cisapride (użat biex jikkura ħruq fl- istonku)
astemizole or terfenadine (used to treat allergy symptoms) bepridil (used to treat heart disease) cisapride (used to treat heartburn) ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraine and cluster headaches)
- ergot alkaloids (eżempju, ergotamine, dihydroergotamine, ergonovine, u
- - -
methylergonovine) (użati biex jikkuraw l- emikranji u uġigħ ta ’ ras regolari)
midazolam or triazolam (used to help you sleep) pimozide (used to treat certain mental conditions) St.
- midazolam jew triazolam (użati biex jgħinuk torqod)
John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)
John' s wort (Hypericum perforatum) (rimedju erbali użat biex jikkura depressjoni
If you are taking any of these medicines, tell your doctor immediately.
Jekk qed tieħu xi waħda minn dawn il- mediċini, għid lit- tabib tiegħek minnufih.
Taking these medicines with STOCRIN could create the potential for serious and/ or life-threatening side-effects or stop 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.
192 Take special care with STOCRIN • STOCRIN must be taken with other medicines that act against the HIV virus.
206 • STOCRIN irid jittieħed ma ’ mediċini oħra li jaħdmu kontra l- virus ta ’ l- HIV.
If STOCRIN is started because your current treatment has not prevented the virus from multiplying, another medicine you have not taken before must be started at the same time.
Jekk STOCRIN jinbeda għax il- kura preżenti ma waqqfitx il- virus milli joktor, trid tibda fl- istess ħin mediċina oħra li ma kontx qed tieħu qabel.
• You can still pass on HIV when taking this medicine, so it is important to take precautions to avoid infecting other people through sexual contact or blood transfer.
• Xorta tista ’ tgħaddi l- HIV lil ħaddieħor meta tkun qed tieħu din il- mediċina, għalhekk huwa importanti li tieħu prekawzjonijiet sabiex tevita milli tinfetta lil ħaddieħor permezz ta ’ kuntatt sesswali jew trasferiment ta ’ demm.
This medicine is not a cure for HIV infection and you may continue to develop infections or other illnesses associated with HIV disease.
Din il- mediċina mhix kura għall- infezzjoni ta ’ l- HIV u tista ’ tkompli tiżviluppa infezzjonijiet jew mard ieħor marbuta ma ’ l- HIV.
• You must remain under the care of your doctor while taking STOCRIN.
• Waqt li qed tieħu STOCRIN trid tibqa ’ taħt il- kura tat- tabib tiegħek.
• Tell your doctor:
• Għid lit- tabib tiegħek:
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- Jekk għandek storja ta ’ mard mentali, inkluż depressjoni, jew ta ’ abbuż minn
if you have a history of mental illness, including depression, or of substance or alcohol abuse.
sustanzi jew alkoħol.
Tell your doctor immediately if you feel depressed, have suicidal thoughts or have strange thoughts (see section 4, Possible side effects).
Għid lit- tabib tiegħek minnufih jekk tħossok imdejjaq, jgħaddulek ħsibijiet ta ’ suwiċidju jew ikollok ħsibijiet strambi (ara sezzjoni 4, Effetti sekondarji possibbli).
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- jekk għandek storja ta ’ konvulżjonijiet (attakki jew kollassi) jew jekk tkun qed
if you have a history of convulsions (fits or seizures) or if you are being treated with anticonvulsant therapy such as carbamazepine, phenobarbital and phenytoin.
tiġi kkurat/ a b’ terapija antikonvulsanti bħal carbamazepine, phenobarbital u phenytoin.
If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant medicine in your blood to ensure that it is not affected while taking STOCRIN.
Jekk qed tieħu xi mediċina minn dawn, it- tabib tiegħek jista ’ jkollu bżonn li jara l- livell ta ’ mediċina antikonvulsanti fid- demm tiegħek sabiex jiżgura li dan ma jkunx affettwat waqt li tkun qed tieħu STOCRIN.
Your doctor may give you a different anticonvulsant.
It- tabib tiegħek jista ’ jagħtik antikonvulsant differenti.
if you have a history of liver disease, including active chronic hepatitis.
- jekk għandek storja medika ta ’ mard fil- fwied inkluż epatite kronika attiva.
Patients with chronic hepatitis B or C and treated with combination antiretroviral agents have a higher risk for severe and potentially life-threatening liver problems.
Pazjenti b’ epatite B jew C kronika u li huma kkurati b’ aġenti antiretrovirali ta ’ kombinazzjoni għandhom riskju ikbar li jiżviluppaw problemi tal- fwied serji jew li saħansitra jistgħu jkunu ta ’ theddid għall- ħajja.
Your doctor may conduct blood tests in order to check how well your liver is working.
It- tabib tiegħek jista ’ jwettaq testijiet tad- demm sabiex jara kemm ikun qiegħed jaħdem tajjeb il- fwied tiegħek.
If you have severe liver disease, do not take STOCRIN (see Section 2, Do not take STOCRIN).
Jekk ikollok mard fil- fwied serju, tiħux STOCRIN (ara Sezzjoni 2, Tiħux STOCRIN).
• Once you start taking STOCRIN, look out for:
• Ladarba tibda tieħu STOCRIN oqgħod attent/ a għal:
signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating or abnormal dreaming.
- sinjali ta ’ sturdament, diffikultà fl- irqad, ħedla, diffikultà fil- konċentrazzjoni
These side effects may start in the first 1 or 2 days of treatment and usually go away after the first 2 to 4 weeks.
Dawn l- effetti sekondarji jistgħu jibdew fl- ewwel jum jew jumejn tat- trattament u normalment jisparixxu wara l- ewwel ġimagħtejn sa 4 ġimgħat.
any signs of skin rash.
- kwalunkwe sinjal ta ’ raxx tal- ġilda.
If you see any signs of a severe rash with blistering or fever, stop taking STOCRIN and tell your doctor at once.
jew deni, waqqaf STOCRIN u għid lit- tabib tiegħek minnufih.
If you had a rash while taking another NNRTI, you may be at a higher risk of getting a rash with STOCRIN.
Jekk kellek raxx meta kont qed tieħu NNRTI ieħor, tista ’ tkun f’ riskju akbar li jkollok raxx bi STOCRIN.
any signs of inflammation or infection.
- kwalunkwe sinjal ta ’ infjammazzjoni jew infezzjoni.
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
infezzjoni avvanzata ta ’ l- HIV (AIDS) u storja ta ’ infezzjoni opportunistika, jista ’ jkun li ftit wara li tibda l- kura kontra l- HIV, iseħħu sinjali u sintomi ta ’ infjammazzjoni minn infezzjonijiet li ġew qabel.
It is believed that these symptoms are due to an improvement in the body’ s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Huwa maħsub li dan jiġri minħabba li r- rispons immunitarju tal- ġisem jitjieb, u għalhekk il- ġisem jibda jikkumbatti l - infezzjonijiet li setgħu kienu hemm mingħajr sintomi ovvji.