qanastek/EMEA-V3 huggingface dataset:
The presence of K103N alone, which was the most prevalent NNRTI mutation in DUET-1 and DUET-2 at baseline, was not identified as a mutation associated with resistance to INTELENCE.
Il- preżenza ta ’ K103N waħdu, li kien il- mutazzjoni ta ’ NNRTI l- iktar prevalenti fil- provi DUET- 1 u DUET- 2 fil- linja bażi, ma ’ kienx identifikat bħala mutazzjoni assoċċjata ma ’ reżistenza għal INTELENCE.
Furthermore, the presence of this mutation alone did not affect the response in the INTELENCE arm.
Barra minn hekk, il- preżenza ta ’ din il- mutazzjoni weħida ma affettwatx ir- rispons fil - fergħa ta ’ INTELENCE.
Additional data is required to conclude on the influence of K103N when associated with other NNRTIs mutations.
Hemm bżonn ta ’ iktar tagħrif sabiex wieħed jikkonkludi fuq l- influwenza ta ’ K103N meta assoċċjat ma ’ mutazzjonijiet ta ’ NNRTIs oħrajn.
Data from the DUET studies suggest that baseline fold change (FC) in EC50 to etravirine was a predictive factor of virologic outcome, with gradually decreasing responses observed above FC 3 and FC 13.
Tagħrif mill- istudji DUET jissuġgerixxi illi l- bidla (FC) fil- linja bażi f ’ EC50 għal etravirine kien fattur li jbassar r- riżultat viroloġiku, b’ risponsi li jonqsu b’ mod gradwali osservati ‘ l fuq minn FC3 u FC13.
FC subgroups are based on the select patient populations in DUET-1 and DUET-2 and are not meant to represent definitive clinical susceptibility breakpoints for INTELENCE.
Issottogruppi FC huma bbażati fuq il- popolazzjonijiet ta ’ pazjenti magħżula f’ DUET- 1 u DUET- 2 u m’ humiex intiżi sabiex jirrapreżentaw breakpoints definittivi kliniċi ta ’ suxxettibilita` għal INTELENCE.
Exploratory head to head comparison with protease inhibitor in protease inhibitor naïve patients (trial TMC125-C227) TMC125-C227 was an exploratory, randomised, active-controlled open-label trial, which investigated the efficacy and safety of INTELENCE in a treatment regimen, which is not approved under the current indication.
Paragun esploratorju ras għal ras ma ’ impeditur ta ’ protease f’ pazjenti li ma jafux li qed jieħdu impedituri ta ’ protease (prova TMC 125- C227) TMC125- C227 kienet prova esploratorja, randomised, kontrollata- attiva open- label, li investigat l - effikaċja u sikurezza ta ’ INTELENCE f’ reġimen ta ’ trattament, li mhux approvat taħt l- indikazzjoni kurrenti.
In the TMC125-C227 study, INTELENCE (N=59) was administered with 15 2 investigator-selected NRTIs (i.e. without a ritonavir-boosted PI) and compared to an investigator-selected combination of a PI with 2 NRTIs (N=57).
Fl- istudju TMC125- C227, INTELENCE (N=59) kien amministrat ma ’ 2 NRTIs (i. e. mingħajr PI ibbustjat b’ ritonavir) magħżula mill- investigatur u mqabbel ma ’ kombinazzjoni ta ’ PI magħżula mill- investigatur ma ’ żewġ NRTIs (N=57).
The trial population included PI-naïve, NNRTI-experienced patients with evidence of NNRTI resistance.
Il- popolazzjoni tal - prova inkludiet pazjenti li ma kienux jafu li qed jieħdu PI, esperjenzati b’ NNRTI b’ evidenza ta ’ reżistenza għal NNRTI.
At week 12, virologic response was greater in the control-PI arm (-2.2 log10 copies/ml from baseline; n=53) compared to the INTELENCE arm (-1.4 log10 copies/ml from baseline; n=40).
F’ ġimgħa 12, ir- rispons viroloġiku kien ogħla fil- fergħa ta ’ kontroll- PI (- 2. 2 log10 kopji/ ml mill- linja bażi; n=53) imqabbel mal- fergħa ta ’ INTELENCE (- 1. 4 log10 kopji/ ml mill- linja bażi; n=40).
This difference between treatment arms was statistically significant.
Din id - differenza bejn il- fergħat ta ’ trattament kienet statistikament sinjifikanti.
Based on these trial results, INTELENCE is not recommended for use in combination with N(t)RTIs only in patients who have experienced virological failure on an NNRTI- and N(t)RTI-containing regimen.
Ibbażat fuq ir- riżultati ta ’ dawn il- provi, INTELENCE mhux irrakkomandat għall- użu f’ kombinazzjoni ma ’ N( t) RTIs biss f’ pazjenti li esperjenzaw falliment viroloġiku fuq reġiment li jikkontjeni NNRTI - u N( t) RTI.
This medicinal product has been authorised under a so-called “conditional approval” scheme.
Dan il- prodott mediċinali kien awtorizzat taħt dik li tissejjaħ skema ta ’ ‘ approvazzjoni b’ kondizzjoni ’.
This means that further evidence on this medicinal product is awaited.
Dan ifisser li għad trid tingħata aktar evidenza dwar dan il- prodott mediċinali.
The European Medicines Agency (EMEA) will review new information on the product every year and this SPC will be updated as necessary.
L- Aġenzija Ewropeja dwar il- Mediċini (EMEA) ser tirrevedi l- informazzjoni l- ġdida dwar il- prodott kull sena u ser taġġorna dan is- Sommarju tal- Karatteristiċi tal- Prodott, skond il- bżonn.
The pharmacokinetic properties of etravirine have been evaluated in adult healthy subjects and in adult treatment-experienced HIV-1 infected patients.
Il- proprjetajiet farmakokinetiċi ta ’ etravirine ġew evalwati fuq individwi adulti f’ saħħithom u f’ pazjenti adulti esperjenzati fit- trattament infettati b’ HIV- 1.
Exposure to etravirine was lower (35-50%) in HIV-1 infected patients than in healthy subjects.
Espożizzjoni għal etravirine kien inqas (35- 50%) f’ pazjenti infettati b’ HIV- 1 milli f’ suġġetti f’ saħħithom.
Absorption An intravenous formulation of etravirine is unavailable, thus, the absolute bioavailability of etravirine is unknown.
Assorbiment Mhux disponibbli formulazzjoni għal ġol- vini ta ’ etravirine, għalhekk, mhux magħrufa l - bijodisponibilita` assoluta ta ’ etravirine.
After oral administration with food, the maximum plasma concentration of etravirine is generally achieved within 4 hours.
Wara teħid orali ma ’ l- ikel, il- konċentrazzjoni massima ta ’ etravirine fil- plażma ġeneralment tintlaħaq fi żmien 4 sigħat.
In healthy subjects, the absorption of etravirine is not affected by co-administration of oral ranitidine or omeprazole, medicinal products that are known to increase gastric pH.
F’ individwi f’ saħħithom, l- assorbiment ta ’ etravirine mhux affettwat bit- teħid ta ’ ranitidine orali jew omeprazole, prodotti mediċinali magħrufa li jżidu l- pH gastriku.
Effect of food on absorption The systemic exposure (AUC) to etravirine was decreased by about 50% when INTELENCE was administered under fasting conditions, as compared to administration following a meal.
L- effett ta ’ l- ikel fuq l- assorbiment L- espożizzjoni sistemika (AUC) għal etravirine tnaqqset b’ 50% meta INTELENCE ngħata taħt kundizzjonijiet ta ’ sawm, meta mqabbel ma ’ teħid wara ikla.
Therefore, INTELENCE should be taken following a meal.
Għalhekk, INTELENCE għandu jittieħed wara ikla.
Distribution Etravirine is approximately 99.9% bound to plasma proteins, primarily to albumin (99.6%) and α1-acid glycoprotein (97.66%-99.02%) in vitro.
16 Etravirine bejn wieħed u ieħor huwa 99. 9% marbut ma ’ proteini tal- plażma, primarjament ma ’ albumin (99. 6%) u α1- acid glycoprotein (97. 66% - 99. 02%) in vitro.
The distribution of etravirine into compartments other than plasma (e.g., cerebrospinal fluid, genital tract secretions) has not been evaluated in humans.
Id- distribuzzjoni ta ’ etravirine f’ kompartimenti oħrajn apparti l- plażma (eż. fluwidu ċerebrospinali, tnixxija mill- apparat ġenitali) ma ġiex evalwat fil- bnedmin.
Metabolism In vitro experiments with human liver microsomes (HLMs) indicate that etravirine primarily undergoes oxidative metabolism by the hepatic cytochrome CYP450 (CYP3A) system and, to a lesser extent, by the CYP2C family, followed by glucuronidation.
Metaboliżmu Esperimenti in vitro b’ mikrosomi tal- fwied uman (HLMs) jindikaw li etravirine primarjament jgħaddi minn metaboliżmu ossidativ mis- sistema taċ- ċitokromju epatiku CYP450 (CYP3A) u, b’ inqas, mill - familja CYP2C, segwit minn glukuronidazzjoni.
Elimination After administration of a radiolabeled 14C-etravirine dose, 93.7% and 1.2% of the administered dose of 14 C-etravirine could be retrieved in faeces and urine, respectively.
Eliminazzjoni Wara teħid ta ’ doża ta ’ 14C- etravirine radjutikkettata, 93. 7% u 1. 2% tad- doża meħuda ta ’ 14C- etravirine setgħet tiġi rintraċċjata fl- ippurgar u l- awrina, rispettivament.
Unchanged etravirine accounted for 81.2% to 86.4% of the administered dose in faeces.
Etravirine mhux mibdul kien jammonta għal 81. 2% sa 86. 4% tad- doża meħuda fl- ippurgar.
Unchanged etravirine in faeces is likely to be unabsorbed drug.
Etravirine mhux mibdul fl- ippurgar probabbilment huwa mediċina mhux assorbita.
Unchanged etravirine was not detected in urine.
Etravirine mhux mibdul ma ġiex traċċat fl- awrina.
The terminal elimination half-life of etravirine was approximately 30-40 hours.
Il- half- life ta’ l - eliminazzjoni terminali ta ’ etravirine kienet madwar 30- 40 siegħa.
Special populations Paediatric population The pharmacokinetics of etravirine in paediatric patients are under investigation.
Popolazzjonijiet speċjali Popolazzjoni pedjatrika Il- farmakokinetika ta ’ etravirine f’ pazjenti pedjatriċi qiegħda taħt investigazzjoni.
There are insufficient data at this time to recommend a dose (see section 4.2).
Hemm tagħrif insuffiċjenti f’ dan iż- żmien sabiex tiġi rrakkomandata doża (ara sezzjoni 4. 2).
16 Elderly Population pharmacokinetic analysis in HIV infected patients showed that etravirine pharmacokinetics are not considerably different in the age range (18 to 77 years) evaluated, with 6 subjects aged 65 years or older (see sections 4.2 and 4.4).
Anzjani Analiżi tal- farmakokinetika tal- popolazzjoni f’ pazjenti infettati bl- HIV uriet illi l- farmakokinetika ta ’ etravirine mhix differenti konsiderevolment fil- marġini tal- etajiet (18 sa 77 sena) evalwati, b’ 6 individwi ta ’ eta` ta ’ 65 sena jew iktar (ara sezzjonijiet 4. 2 u 4. 4).
Gender No significant pharmacokinetic differences have been observed between men and women.
Sess Ma ġewx osservati differenzi farmakokinetiċi sinjifikanti bejn irġiel u nisa.
A limited number of women were included in the studies.
Numru limitat ta ’ nisa ġew inklużi f’ dan l- istudji.
Race Population pharmacokinetic analysis of etravirine in HIV infected patients indicated no apparent difference in the exposure to etravirine between Caucasian, Hispanic and Black subjects.
Razza Analiżi tal- farmakokinetika tal- popolazzjoni ta ’ etravirine f’ pazjenti infettati bl- HIV ma indikatx differenzi apparenti fl- espożizzjoni għal etravirine bejn individwi Kawkasi, Ispaniċi u Suwed.
The pharmacokinetics in other races have not been sufficiently evaluated.
Il - farmakokinetika f’ razez oħrajn ma ġewx evalwati suffiċjentement.
Hepatic impairment Etravirine is primarily metabolised and eliminated by the liver.
Indeboliment epatiku Etravirine huwa primarjament metabolizzat u eliminat mill- fwied.
In a study comparing 8 patients with mild (Child-Pugh Class A) hepatic impairment to 8 matched controls and 8 patients with moderate (Child-Pugh Class B) hepatic impairment to 8 matched controls, the multiple dose pharmacokinetic disposition of etravirine was not altered in patients with mild to moderate hepatic impairment.
Fi studju li qabbel 8 pazjenti b’ indeboliment tal- fwied ħafif (Child- Pugh Klassi A) ma ’ 8 kontrolli mqabbla u 8 pazjenti b’ indeboliment tal- fwied moderat (Child- Pugh Klassi B) ma ’ 8 kontrolli mqabbla, id- dispożizzjoni farmakokinetika għal doża multipla ta ’ etravirine ma nbidlitx f’ pazjenti b’ indeboliment tal- fwied ħafif għal moderat.
However, unbound concentrations have not been assessed.
Madanakollu, konċentrazzjonijiet mhux marbuta ma ġewx assessjati.
Increased unbound exposure could be expected.
Tista tkun mistennija żieda fl- espożizzjoni mhux marbuta.
No dose adjustment is suggested but caution is adviced in patients with moderate hepatic impairment.
Mhux suġġerit aġġustament fid- doża iżda f’ pazjenti b’ indeboliment epatiku moderat hija rrakkomandata l- kawtela.
INTELENCE has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and is therefore not recommended (see sections 4.2 and 4.4).
INTELENCE ma ġiex studjat f’ pazjenti b’ indeboliment tal- fwied qawwi (Child- Pugh Klassi C) u għalhekk mhux irrakkomandat (ara sezzjonijiet 4. 2 u 4. 4)
Hepatitis B and/or hepatitis C virus co-infection Population pharmacokinetic analysis of the DUET-1 and DUET-2 trials showed reduced clearance (potentially leading to increased exposure and alteration of the safety profile) for INTELENCE in HIV-1 infected patients with hepatitis B and/or hepatitis C virus co-infection.
Ko- infezzjoni ta ’ virus Epatite B u/ jew Epatite C Analiżi tal- farmakokinetika tal- popolazzjoni tal- provi DUET- 1 u DUET- 2 wrew tnaqqis fit- tneħħija ridotta (potenzjalment iwassal għal żieda fl- espożizzjoni u bidla fil- profil ta ’ sigurta`) għal INTELENCE f’ pazjenti infettati kemm b’ HIV- 1 kif ukoll bil- virus epatite B u/ jew epatite C.
In view of the limited data available in hepatitis B and/or C co-infected patients, particular caution should be paid when INTELENCE is used in these patients (see sections 4.4 and 4.8).
Minħabba t- tagħrif limitat disponibbli f’ pazjenti infettati ukoll b’ epatite B u/ jew epatite C, għandha tingħata kawtela partikolari meta INTELENCE jintuża f’ dawn il- pazjenti (ara sezzjonijiet 4. 4 u 4. 8).
Renal impairment The pharmacokinetics of etravirine have not been studied in patients with renal insufficiency.
Indeboliment renali Il- farmakokinetika ta ’ etravirine ma ġietx studjata f’ pazjenti b’ indeboliment renali.
Results from a mass balance study with radioactive 14C-etravirine showed that < 1.2% of the administered dose of etravirine is excreted in the urine.
Ir- riżultati minn 17 studju ta ’ bilanċ tal- massa b’ 14C- etravirine radjoattiv wera li < 1. 2% tad- doża li tittieħed toħroġ fl - awrina.
No unchanged drug was detected in urine so the impact of renal impairment on etravirine elimination is expected to be minimal.
Ma ġietx traċċata mediċina mhux mibdula fl- awrina u għalhekk huwa mistenni li l- impatt ta ’ indeboliment renali fuq l- eliminazzjoni ta ’ etravirine huwa minimu.
As etravirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis (see section 4.2).
Peress illi etravirine huwa marbut ħafna mal- proteina tal- plażma, huwa improbabbli li jitneħħa b’ mod sinjifikanti permezz ta ’ l - emodijalisi jew dijalisi tal- peritonew (ara sezzjoni 4. 2).
Animal toxicology studies have been conducted with etravirine in mice, rats, rabbits and dogs.
Studji tossikoloġiċi fuq l- annimali saru b’ etravirine fuq ġrieden, firien, fniek u klieb.
In mice, the key target organs identified were the liver and the coagulation system.
Fi ġrieden l - organi prinċipali mmirati identifikati kienu l- fwied u s- sistema ta ’ koagulazzjoni.
Haemorrhagic cardiomyopathy was only observed in male mice and was considered to be secondary to severe coagulopathy mediated via the vitamin K pathway.
Kardjomijopatija emorraġika ġiet osservata fi ġrieden maskili biss u ġiet ikkunsidrata bħala sekondarja għal koagulopatija qawwija medjata via r- rotta tal- vitamina K.
In the rat, the key target organs identified were the liver, the thyroid and the coagulation system.
Fil- far, l- organi prinċipali immirati identifikati kienu l- fwied, it- tirojde u s- sistema ta ’ koagulazzjoni.
Exposure in mice was equivalent to human exposure while in rats it was below the clinical exposure at the recommended dose.
L- espożizzjoni fil- ġrieden kienet ekwivalenti għal espożizzjoni umana filwaqt li fil- firien kienet taħt l- espożizzjoni klinika fid- doża rrakkomandata.
In the dog, changes were observed in the liver and gall bladder at exposures approximately 8-fold higher than human exposure observed at the recommended dose (200 mg b.i.d.).
Fil- kelb, ġew osservati bidliet fil- fwied u fil - marrara f’ espożizzjonijiet madwar 8 darbiet ogħla mill- espożizzjoni umana osservata fid- doża rrakkomandata (200 mg b. i. d.).
In a study conducted in rats, there were no effects on mating or fertility at exposure levels equivalent to those in humans at the clinically recommended dose.
Fi studju magħmul fuq firien, ma kienx hemm effetti fuq tgħammir u fertilita` f’ livelli ta ’ espożizzjoni ekwivalenti għal dawk fil- bnedmin fid- doża rrakkomandata klinikament.
There was no teratogenicity with etravirine in rats and rabbits at exposures equivalent to those observed in humans at the recommended clinical dose.
Ma kienx hemm teratoġeniċita` b’ etravirine f’ firien u fniek f’ espożizzjoni ekwivalenti għal dawk osservati fil- bnedmin fid- doża rrakkomandata klinikament.
Etravirine had no effect on offspring development during lactation or post weaning at maternal exposures equivalent to those observed at the recommended clinical dose.
Etravirine ma kellux effett fuq l- iżvilupp taż- żgħar waqt treddigħ jew wara ftim f’ espożizzjonijiet materni ekwivalenti għal dawk osservati fid- doża klinika rrakomandata.
17 Carcinogenicity studies of etravirine in rodents are ongoing.
Studji dwar karċinoġeniċita` ta ’ etravirine fuq annimali gerriema għadhom għaddejjin.
In vitro and in vivo studies with etravirine revealed no evidence of a mutagenic potential.
Studji in vitro u in vivo b’ etravirine ma ’ wrewx evidenza ta ’ potenzjal mutaġeniku.
Hypromellose Microcrystalline cellulose Colloidal anhydrous silica Croscarmellose sodium Magnesium stearate Lactose monohydrate
Hypromellose Microcrystalline cellulose Colloidal anhydrous silica Croscarmellose sodium Magnesium stearate Lactose monohydrate
Keep the bottle tightly closed in order to protect from moisture.
Żomm il- flixkun magħluq sewwa sabiex tilqa ’ mill- umdita`.
Do not remove the desiccant pouches.
Tneħħix il - qratas desikkanti.
High-density polyethylene (HDPE) plastic bottles containing 120 tablets and 3 desiccant pouches, fitted with polypropylene (PP) child resistant closures.
Fliexken tal- plastik tal- polyethylene ta ’ densita` għolja (HDPE) li fihom 120 pillola u 3 qratas desikkanti, li għandhom għatu tal- polypropylene (PP) reżistenti għat- tfal.
Each carton contains one bottle.
18 Kull kartuna fiha flixkun wieħed.
Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium
Janssen- Cilag International NV Turnhoutseweg 30 B- 2340 Beerse Il- Belġju
Detailed information on this medicinal product is available on the website 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 /.
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ Ċ.
Janssen 04010 Borgo San Michele Latina Italy
Janssen 04010 Borgo San Michele Latina L- Italja
The MAH must ensure that the system of pharmacovigilance, as described in version 4 (dated 8 May 2008) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
L- MAH għandu jiżgura li s- sistema ta ’ farmakoviġilanza kif deskritta f’ verżjoni 4 (datat 8 ta ’ Mejju 2008) ippreżentat f’ Modulu 1. 8. 1 tal- Applikazzjoni għal Awtorizazzjoni għat- Tqegħid fuq is- Suq, hija f’ posta u tiffunzjona qabel u waqt li l- prodott qiegħed fuq is- suq.
Risk Management plan
Pjan għall- Immaniġġjar tar- Riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.3 (dated 24 June 2008) 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.
L- MAH jikkommetti ruħu li jagħmel l- istudji u attivitajiet ta ’ farmakoviġilanza addizzjonali dettaljati fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem f’ verżjoni 1. 3 (datat 24 ta ’ Ġunju 2008) tal- Pjan għall - Immaniġġjar tar- Riskju (RMP) ippreżentat f’ Modulu 1. 8. 2 tal- Applikazzjoni għal Awtorizazzjoni għat- Tqegħid fuq is- Suq u xi aġġornamenti sussegwenti tal- RMP kif miftiehma mill- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linji gwida tal- CHMP dwar Sistemi tal- Immaniġġjar tar- Riskju għal prodotti mediċinali għal użu mill- bniedem, l- RMP aġġornat għandu jiġi sottomess fl- istess ħin mar- Rapport ta ’ Aġġornament ta ’ Sikurezza Perjodika (PSUR) li jmiss.
In addition, an updated RMP should be submitted
Barra minn hekk, RMP aġġornat għandu jiġi sottomess
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities.
Meta tiġi riċevuta informazzjoni ġdida li jista jkollha impatt fuq il- Pjan ta ’ Speċifikazzjoni ta ’ Sikurezza kurrenti, Farmakoviġilanza kurrenti jew attivitajiet li jnaqqsu r- riskju.
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached.
Fi żmien 60 ġurnata minn meta tkun intlaħqet mira importanti (farmakoviġilanza jew tnaqqis tar- riskju).
At the request of the EMEA.
Fuq talba tal- EMEA
SPECIFIC OBLIG ATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
21 Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jtemm il- programm ta 'studji li ġejjin fiż- żmien speċifikat.
The results of which shall be taken into account in the risk benefit balance during the assessment of the application for a renewal.
Ir- riżultati ta 'dawn l- istudji għandhom iservu ta' bażi għall- istima tal- profil bejn il- benefiċċju/ riskju li jsir mal- applikazzjoni għat- tiġdid.
Area Clinical
Erja Kliniku
Description The applicant will provide the final report of the pooled 48 weeks data from the two pivotal trials C206 and C216 (DUET-1 and DUET-2) to substantiate the durability of the virologic suppression achieved with etravirine and to further assess the safety profile of the compound.
Deskrizzjoni L- applikant għandu jipprovdi ir- rapport finali tat- tagħrif miġbur ta ’ 48 ġimgħa miż- żewġ provi ċentrali C206 u C216 (DUET- 1 u DUET- 2) sabiex jissustanzja d- durabilita` tas- suppressjoni viroloġika ottenuta b’ etravirine u sabiex ikompli jassessja ulterjorment il- profil ta ’ sikurezza tal- prodott.
A proposal for an update of the SmPC and Package Leaflet based on the available data will be provided in parallel.
Proposta ta ’ aġgornament tal- SmPC u l- Fuljett ta ’ Tagħrif ibbażat fuq it- tagħrif disponibbli jiġi pprovdut fl- istess żmien.
Due date 31 December 2008
Data ta ’ Temm 31 ta ’ Diċembru 2008
The applicant will provide the draft protocol of the study to the CHMP for agreement before study start.
L- applikant jikkometti ruħu li jagħmel studju ta ’ konferma bl - obbjettiv li jipprovdi assikurazzjoni fuq l- estrapolazzjoni tar - riżultati tal- istudju miż- żewġ studji ċentrali( DUET- 1 u DUET- 2) tal- użu kombinat ta ’ etravirine ma ’ PIs ibbustjati apparti darunavir/ ritonavir.
The applicant will provide regular updates on study progress within the PSURs.
Għandu jitwaqqaf DSMB.
31 August 2008 (draft protocol)
31 ta ’ Awissu 2008 L- applikant għandu jipprovdi skeċċ ta ’ protokol ta ’ l- istudju lil (abbozz tal- protokol) CHMP għal ftehim qabel ma jinbeda l- istudju.
The final study report will be submitted for assessment whether the objective of the study has been met.
L- applikant għandu jipprovdi aġgornamenti regolari fuq progress ta ’ l- situdju fil- PSURs.
30 June 2012 (Final CSR*)
30 ta ’ Ġunju 2012 Ir- rapport finali tal- istudju jiġi sottomess għall - assessjar biex jiġi (CSR * finali) definit jekk intlaħaqx l- obbjetiv tal- istudju.
Study Report
* Rapport ta ’ Studju Kliniku
24 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
24 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
INTELENCE 100 mg tablets etravirine
INTELENCE pilloli 100mg etravirine
Each tablet contains 100 mg etravirine.
Kull pillola fiha 100mg etravirine
See leaflet for further information.
Fih lactose monohydrate Ara l- fuljett għal iktar tagħrif.
120 tablets
120 pillola
Oral use Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel l- użu.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
25 UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
26 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
26 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Contains lactose monohydrate.
Fih lactose monohydrate
What INTELENCE is and what it is used for 2.
X’ inhu INTELENCE u għalxiex jintuża 2.
Before you take INTELENCE 3.
Qabel ma tieħu INTELENCE 3.
How to take INTELENCE 4.
Kif għandek tieħu INTELENCE 4.
How to store INTELENCE 6.
Kif taħżen INTELENCE 6.
WHAT INTELENCE IS AND WHAT IT IS USED FOR
X’ INHU INTELENCE U GĦALXIEX JINTUŻA
INTELENCE is a medicine used for the treatment of Human Immunodeficiency Virus (HIV) infection.
INTELENCE hija mediċina li tintuża għat- trattament tal- infezzjoni tal - virus ta ’ l- Immunodefiċjenża umana( HIV).
It belongs to a group of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Hija tagħmel parti minn grupp ta ’ mediċini kontra HIV imsejjħin impedituri tan- non - nucleoside reverse transcriptase (NNRTIs).
INTELENCE works by reducing the amount of HIV in your body.
INTELENCE jaħdem billi jnaqqas l- ammont ta ’ HIV f’ ġismek.
This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.
Dan itejjeb is- sistema immunitarja tiegħek u jnaqqas r- riskju li tiżviluppa mard konness mal - infezzjoni HIV.
INTELENCE is used in combination with other anti -HIV medicines to treat adults who are infected by HIV and who have used other anti-HIV medicines before.
INTELENCE jintuża f’ kombinazzjoni ma ’ mediċini oħrajn kontra l- HIV sabiex jittratta adulti infetati bl- HIV u li użaw mediċini oħrajn kontra l- HIV qabel.
Your doctor will discuss with you which combination of medicines is best for you.
It- tabib tiegħek ser jiddiskuti miegħek il- kombinazzjoni ta ’ mediċini li huma l- aħjar għalik.
BEFORE YOU TAKE INTELENCE
QABEL MA TIEĦU INTELENCE
Do not take INTELENCE
Tieħux INTELENCE
- if you are allergic (hypersensitive) to etravirine or any of the other ingredients of INTELENCE.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal etravirine jew sustanzi oħra ta ’
These other ingredients are listed in section 6.
Dawn is- sustanzi l- oħrajn huma elenkati f’ sezzjoni 6.
Take special care with INTELENCE INTELENCE is not a cure for HIV infection.
Oqgħod attent ħafna b’ INTELENCE INTELENCE m’ huwiex kura għall- infezzjoni HIV.
It is part of a treatment reducing the amount of virus in the blood.
Huwa parti minn trattament li jnaqqas l- ammont tal- virus fid- demm tiegħek.
INTELENCE does not reduce the risk of passing HIV to others through sexual contact or contamination with blood.
INTELENCE ma jnaqqasx ir- riskju li tgħaddi l- HIV lil ħaddieħor b’ kuntatt sesswali jew kontaminazzjoni mid- demm.
Therefore, you must continue to use appropriate precautions (a condom or other barrier method) to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions or blood.
Għalhekk, għandek tkompli tuża prekawzjonijiet xierqa (kondom jew metodu ta ’ barriera) sabiex tnaqqas iċ- ċans ta ’ kuntatt sesswali ma ’ xi fluwidu tal - ġisem bħal semen, tnixxija vaġinali jew demm.
People taking INTELENCE may still develop infections or other illnesses associated with HIV infection.
Nies li jieħdu INTELENCE xorta jistgħu jiżviluppaw infezzjonijiet jew mard ieħor assoċċjat mal - infezzjoni HIV.
You must keep in regular contact with your doctor.
Għandek iżżomm kuntatt regolari mat- tabib tiegħek.
INTELENCE is not for use in children or adolescents, because it has not been sufficiently studied in patients under 18 years of age.
30 INTELENCE m’ huwiex għall- użu mit- tfal jew addoloxxenti minħabba li ma ġiex studjat b’ mod suffiċjenti f’ pazjenti taħt it- 18- il sena.
INTELENCE has only been used in a limited number of patients of 65 years or older.
INTELENCE ntuża f’ numru limitat ta ’ pazjenti ta ’ 65 sena jew akbar.
If you belong to this age group, please discuss the use of INTELENCE with your doctor.
Jekk inti tagħmel parti minn dan il- grupp ta ’ eta` għandek tiddiskuti l- użu ta ’ INTELENCE mat- tabib tiegħek.
30 Tell your doctor about your situation Make sure that you check the following points and tell your doctor if any of these apply to you.
Ara li tiċċekkja l- punti li ġejjin u tgħid lit- tabib tiegħek jekk xi wħud minn dawn japplikaw għalik.
- Tell your doctor if you develop a rash.
- Għid lit- tabib tiegħek jekk tiżviluppa xi raxx.
If a rash occurs, it usually appears soon after anti-HIV
Jekk jaqbdek raxx, dan ġeneralment jitfaċċa ftit
treatment with INTELENCE is started and often disappears within 1 to 2 weeks, even with continued use of the medicine.
wara li tibda t- trattament b’ INTELENCE u spiss jisparixxi fi żmien 1 sa 2 ġimgħat, anke bit - tkomplija tal- użu tal- mediċina.
Occasionally a rash may become severe.
Kultant raxx jista jiggrava.
Please contact your doctor if the rash worsens over time.
Kellem it- tabib tiegħek jekk ir- raxx jiggrava maż- żmien.
- Tell your doctor if you have or have had problems with your liver, including hepatitis B and/or
It -
Your doctor may evaluate how severe your liver disease is before deciding if you can take INTELENCE.
tabib tiegħek jista ’ jevalwa kemm hi severa l- marda tal- fwied tiegħek qabel ma jiddeċiedi jekk tistax tieħu INTELENCE.
- Tell your doctor if you notice changes in body shape or fat.
- Għid lit- tabib tiegħek jekk tinduna b’ tibdil fil- figura ta ’ ġismek jew fix- xaħam.
A gain, loss or redistribution of
Żieda, tnaqqis,
body fat may occur if you take a combination of anti-HIV medicines.
jew ridistribuzzjoni tax- xaħam tal- ġisem jista jseħħ jekk tieħu kombinazzjoni ta ’ mediċini kontra l- HIV.
- Tell your doctor immediately if you notice any symptoms of infections.
- Għid lit- tabib tiegħek immedjatament jekk tinduna b’ xi sintomi ta ’ infezzjonijiet.
In some patients with
F’ ċerti pazjenti
advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
b’ infezzjoni ta ’ HIV avvanzata u b’ passat ta ’ infezzjoni opportunistika, jista ’ jkun hemm sinjali u sintomi ta ’ infjammazzjonijiet minn infezzjonijiet tal- passat ftit wara li jinbeda t- trattament kontra l- HIV.
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 dawn is- sintomi huma minħabba titjib fir- rispons immunitarju tal- ġisem, li jgħin lill- ġisem jiġġieled l- infezzjonijiet li setgħu kienu preżenti mingħajr sintomi ovvji.
Taking other medicines INTELENCE might interact with other medicines.
Meta tieħu mediċini oħra INTELENCE jista ’ jkollu effett fuq mediċini oħrajn.
In most cases, INTELENCE can be combined with anti-HIV medicines belonging to another class.
Fil- maġġoranza tal- każijiet, INTELENCE jista ’ jiġi kkombinat ma ’ mediċini oħrajn kontra l- HIV li jappartjenu għal klassi oħra.
However some combinations are not recommended.
Madanakollu, xi kombinazzjonjiet m’ humiex rrakomandati.
In other cases, increased monitoring and/or a change in the dose of the medicine may be needed.
F’ każijiet oħrajn, żieda fil- monitoraġġ u/ jew bidla fid- doża tal- mediċina tista tkun meħtieġa.
Therefore always tell your doctor which other anti -HIV medicines you take.
Għalhekk dejjem għid lit- tabib tiegħek liema mediċini oħrajn kontra l- HIV qed tieħu.
Furthermore, it is important that you carefully read the package leaflets that are provided with these medicines.
Barra minn hekk, huwa important li taqra sewwa l- fuljetti ta ’ tagħrif li huma pprovduti ma ’ dawn il- mediċini.
Follow your doctor’s instruction carefully on which medicines can be combined.
Segwi l- istruzzjonijiet tat - tabib tiegħek bir- reqqa dwar liema mediċini jistgħu jiġu kkombinati.
It is not recommended to combine INTELENCE with any of the following medicines:
Mhuwiex rrakkomandat li jiġi kkombinat INTELENCE ma ’ kwalunkwe mis- segwenti mediċini
- tipranavir/ritonavir (anti-HIV medicine)
- tipranavir/ ritonavir (mediċina kontra HIV)
- carbamazepine, phenobarbital, phenytoin (medicines to prevent seizures)
- carbamazepine, phenobarbital, phenytoin (mediċini li jipprevjenu l- aċċessjonijiet).
- rifampicin, because it is contraindicated with boosted protease inhibitors, and rifapentine
- rifampicin, minħabba li hu kontra- indikat flimkien ma ’ impedituri protease ibbustjati, u
(medicines to treat some infections such as tuberculosis)
rifapentine (mediċini li jitrattaw ċerti infezzjonijiet bħal tuberkolożi)
- products that contain St John’s wort (Hypericum perforatum) (a herbal product used for
- prodotti li fihom St John’ s wort (Hypericum perforatum) (prodott mill- ħxejjex li jintuża għad -
depression).
dipressjoni).
If you are taking any of these, ask your doctor for advice.
Jekk qed tieħu xi wieħed minn dawn il- mediċini, staqsi lit- tabib tiegħek għal parir.
The effects of INTELENCE or other medicines might be influenced if you take INTELENCE together with any of the following medicines.
L- effetti ta ’ INTELENCE jew tal- mediċini l- oħrajn jistgħu jiġu influwenzati jekk tieħu INTELENCE flimkien ma ’ xi wieħed mis- segwenti mediċini.
Tell your doctor if you take:
Għid lit- tabib tiegħek jekk qed tieħu:
- amiodarone, bepridil, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone and
- amiodarone, bepridil, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone u
quinidine (medicines to treat certain heart disorders, e.g., abnormal heart beat)
quinidine (mediċini li jitrattaw ċerti disturbi tal- qalb, eż. taħbit tal- qalb mhux normali
- warfarin (a medicine used to reduce clotting of the blood).
- warfarin (mediċina li tintuża sabiex tnaqqas l- emboli tad- demm).
Your doctor will have to check your
It- tabib tiegħek ikollu bżonn
blood
jeżaminalek id- demm.
- fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole (medicines to treat fungal
- fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole (mediċini biex jitrattaw
infections)
infezzjonijiet fungali)
- clarithromycin, rifabutin (antibiotics)
- clarithromycin, rifabutin (antibijotiċi)
- diazepam (medicines to treat trouble with sleeping and/or anxiety)
- diazepam (mediċini li jitrattaw problemi ta ’ rqad u/ jew anzjeta`)
Pregnancy and breast-feeding Tell your doctor immediately if you are pregnant.
- dexamethasone (kortikosterojdi li jintuża f’ varjeta` ta ’ kundizzjonijiet bħal infjammazzjoni u
Pregnant women should not take INTELENCE unless specifically directed by the doctor.
Meta tieħu INTELENCE ma ’ l- ikel u max- xorb Huwa importanti li tieħu INTELENCE wara ikla.
HIV infected mothers must not breast-feed, as there is a possibility of infecting the baby with HIV.
Nisa infettati bl- HIV m’ għandhomx ireddgħu, peress illi hemm possibbilita` li tinfetta lit- tarbija bl - HIV.
Driving and using machines No studies on the effects of INTELENCE on the ability to drive and use machines have been performed.
Sewqan u tħaddim ta ’ magni Ma sarux studji fuq l- effett ta ’ INTELENCE fuq l- abilita` tas- sewqan jew tħaddim ta ’ magni.
However, do not drive or operate machines if you feel sleepy or dizzy after taking your medicines.
Madanakollu ssuqx jew tħaddem magni jekk tħossok bi ngħas jew sturdut wara li tieħu l- mediċina tiegħek..
Important information about some of the ingredients of INTELENCE INTELENCE tablets contain lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ INTELENCE Il- pilloli INTELENCE fihom lactose.
If you have been told by your doctor that you have an intolerance to some sugars (lactose), contact your doctor before taking this medicine.
Jekk it- tabib tiegħek qallek li inti għandek intolleranza għal ċerti tipi ta ’ zokkor (lactose), kellem lit- tabib qabel ma tibda tieħu din il- mediċina.
Bone problems Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Problemi fl- għadam Ċerti pazjenti li jieħdu terapija antiretrovirali kkombinata jistgħu jiżviluppaw mard fl- għadam imsejjaħ osteonekrożi (mewt tat- tessut tal- għadam ikkawżat minn telf ta ’ demm milli jiġi supplit fl- għadam).
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
It - tul ta ’ terapija antiretrovirali kkombinata, użu ta ’ kortikosterojdi, konsum ta ’ alkoħol, immunosuppressjoni qawwija, indiċi tal- massa tal- ġisem ogħla, fost oħrajn, jistgħu jkunu ftit mill - ħafna fatturi ta ’ riskju li jiżviluppa dan il- mard.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Sinjali ta ’ osteonekrożi huma ebusija tal- ġogi, uġigħ (speċjalment fil- ġenb, irkoppa u driegħ) u diffikulta` fil- moviment.
HOW TO TAKE INTELENCE
KIF GĦANDEK TIEĦU INTELENCE
Always take INTELENCE exactly as your doctor has told you.
Dejjem għandek tieħu INTELENCE skond il- parir tat- tabib.
Instructions for proper use The usual dose of INTELENCE is two tablets twice a day.
Struzzjonijiet għal użu tajjeb Id- doża ta ’ INTELENCE li ssoltu tingħata hija ta ’ żewġ pilloli darbtejn kuljum.
In the morning, take two 100 milligram INTELENCE tablets, following a meal.
Filgħodu, ħu żewġ pilloli ta ’ 100 milligramma INTELENCE wara l- ikel.
In the evening, take two 100 milligram INTELENCE tablets, following a meal.
Filgħaxija, ħu żewġ pilloli ta ’ 100 milligramma INTELENCE wara l- ikel.
It is important that you take INTELENCE following a meal.
Huwa importanti li tieħu INTELENCE wara l- ikel.
If you take INTELENCE on an empty stomach, only half the amount of INTELENCE is absorbed.
Jekk tieħu INTELENCE fuq stonku vojt, nofs l - ammont biss ta ’ INTELENCE jiġi assorbit.
Swallow the tablets whole with a glass of water.
Ibla l- pilloli sħaħ ma ’ tazza ilma.
Do not chew the tablets.
Tomgħodx il- pilloli.
If you are unable to swallow the INTELENCE tablets whole, you may place the tablets in a glass of water.
Jekk ma tistax tibla l- pilloli INTELENCE sħaħ, tista titfa l- pilloli ġo tazza ilma.
Stir well until the water looks milky, then drink it immediately.
Ħawwad sewwa sakemm l- ilma jidher qisu ħalib, imbagħad ixorbu immedjatament.
Rinse the glass with water several times, and completely swallow the rinse each time to make sure you take the entire dose.
Laħlaħ it- tazza bl- ilma diversi drabi, u ixrob it- tlaħliħa kollha kull darba sabiex taċċerta ruħek li tieħu d- doża kollha.
Removing the child resistant cap
Sabiex tneħħi t- tapp reżistenti għat- tfal
The plastic bottle comes with a child resistant cap and should be opened as follows:
- Għafas it- tapp tal- kamin tal- plastik ‘ l isfel waqt li ddawwar lejn ix -
- -
xellug.
Remove the unscrewed cap.
- Neħħi t- tapp tal- kamin
If you take more INTELENCE than you should Contact your doctor or pharmacist immediately.
Jekk tieħu INTELENCE aktar milli suppost Kellem lit- tabib jew spiżjar tiegħek immedjatament.
If you forget to take INTELENCE If you notice within 6 hours of the time you usually take INTELENCE, you must take the tablets as soon as possible.
Jekk tinsa tieħu INTELENCE Jekk tinduna fi żmien 6 sigħat mill- ħin li ssoltu tieħu INTELENCE, għandek tieħu l- pilloli malajr kemm jista ’ jkun.
Always take the tablets following a meal.
Dejjem ħu l- pilloli wara ikla.
If you
Imbagħad ħu d- doża li jmiss bħas- soltu.
32 notice after 6 hours, then skip the intake and take the next doses as usual.
Jekk tinduna wara 6 sigħat, aqbeż id- doża u ħu d- dożi li jmiss bħas- soltu.
Do not stop using INTELENCE without talking to your doctor first HIV therapy may increase your sense of well-being.
It- terapija ta’ l- HIV tista ġġiegħelek tħossok tajjeb.
Even if you feel better, do not stop taking INTELENCE or your other anti-HIV medicines.
Anke jekk tħossok aħjar, tieqafx tieħu INTELENCE jew il- mediċini l- oħrajn tiegħek kontra l- HIV.
Doing so could increase the risk of the virus developing resistance.
Jekk tagħmel hekk tista ’ twassal għal żieda fir- riskju li l- virus jiżviluppa reżistenza.
Talk to your doctor first.
Kellem lit- tabib tiegħek l- ewwel.
Like any medicine, INTELENCE can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, INTELENCE jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The frequency of possible side effects listed below is defined using the following convention:
Il- frekwenza tal- effetti sekondarji possibbli huma elenkati hawn taħt skond il- konvenzjoni segwenti:
- very common: affects more than 1 user in 10
- komuni ħafna: jaffettwaw iktar minn persuna 1 li tużah minn kull 10
- common: affects 1 to 10 users in 100
- komuni: jaffettwaw iktar minn 1 sa 10 persuni li jużawh minn kull 100
- uncommon: affects 1 to 10 users in 1,000
- mhux komuni: jaffettwaw minn 1 sa 10 persuni li jużawh minn kull 1, 000
- rare: affects 1 to 10 users in 10,000
- rari: jaffettwaw minn 1 sa 10 persuni li jużawh minn kull 10, 000
- very rare: affects less than 1 user in 10,000
- rari ħafna: jafettwaw inqas minn 1 li jużaħ minn kull 10, 000
- not known: frequency cannot be estimated from the available data.
- mhux magħruf: il- frekwenza ma tistax tiġi stmata mit- tagħrif disponibbli
Common side effects
Effetti sekondarji komuni
- changes in some values of your blood cells or chemistry.
- tibdil f’ xi valuri taċ- ċelluli tad- demm jew kimika.
These can be seen in the results from
Dawn jistgħu jidhru fir- riżultati tat- testijiet
blood tests.
tad- demm.
Your doctor will explain these to you.
It- tabib tiegħek jispjegaħhomlok.
Examples are: low red blood cell count, low blood platelet count, high or abnormal blood fat levels, high cholesterol levels, high sugar levels
Eżempji huma: għadd baxx taċ- ċelluli ħomor tad - demm, għadd baxx tal- plejtlits tad- demm, livelli għoljin jew mhux normali tax- xaħam tad - demm, livelli għoljin ta ’ kolesterol, livelli għoljin taz- zokkor.
- headache, tingling or pain in hands or feet, numbness, tiredness, sleeplessness, anxiety
- Uġigħ ta ’ ras, tnemnim jew uġigħ fl- idejn jew saqajn, tirżiħ, għeja, nuqqas ta ’ rqad, anzjeta`
- diarrhoea, nausea, vomiting, heartburn, abdominal pain, inflammation of the stomach, flatulence
- Dijarrea, nawsja, rimettar, ħruq ta ’ stonku, uġigħ addominali, infjammazzjoni tal- istonku, gass
- kidney failure, high blood pressure, diabetes
- Insuffiċjenza renali, pressjoni għolja tad- demm, dijabete
- skin rash.
- Raxx fil- ġilda.
The rash is usually mild to moderate.
Ir- raxx issoltu jkun ħafif għal moderat.
A skin rash might also be a symptom of a rare
Raxx tal- ġilda jista ’ jkun sintomu wkoll
severe situation (rash with blisters typically on lips, mouth and eyes, sometimes with skin peeling).
ta ’ sitwazzjoni severa rari (raxx b’ infafet tipikament fuq ix- xufftejn, ħalq u għajnejn, kultant bil - ġilda titqaxxar).
It is therefore important to contact your doctor if you develop a rash.
Għalhekk huwa importanti li tikkuntattja lit- tabib tiegħek jekk tiżviluppa raxx.
Your doctor will advise you how to deal with your symptoms and whether INTELENCE must be stopped.
It- tabib jgħidlek kif tieħu ħsieb is- sintomi tiegħek u jekk għandekx twaqqaf INTELENCE.
Uncommon side effects
Effetti sekondarji mhux komuni
- heart attack, angina, irregular heart rhythm
- attakk tal- qalb, anġina, ritmu tal- qalb irregolari
- loss of skin sensibility, drowsiness, trembling, fainting, sleepiness, loss of memory, seizures,
- telf ta ’ sensibilita` tal- ġilda, ħedla, rogħda, ħass ħażin, ħedla tan- ngħas, telf ta ’ memorja,
stroke
aċċessjonijiet, puplesija
- blurred vision, dizziness, sluggishness
- viżjoni mċajjpra, sturdament, indolenza
- difficulty breathing
- diffikulta` biex tieħu n- nifs
- dry mouth, mouth inflammation, retching, constipation, distension of the abdomen,
- ħalq xott, infjammazjoni fil- ħalq, tqalligħ, stitikezza, nefħa addominali, infjammazzjoni tal- frixa,
inflammation of the pancreas, vomiting blood, decrease of appetite
tirrimetti d- demm, tnaqqis fl- aptit
- excessive sweating, itching, dry skin, accumulation of fat, swelling of the face and/or throat
- tegħreq eċċessivament, ħakk, ġilda xotta, akkumulazzjoni ta ’ xaħam, nefħa tal- wiċċ u / jew
- allergic reactions (hypersensitivity), symptoms of infection (for example enlarged lymph nodes
- reazzjonijiet allerġiċi (sensittivita` eċċessiva), sintomi ta ’ infezzjoni (per eżempju tkabbir tal -
and fever)
glandoli limfatiċi u deni)
- liver problems such as hepatitis
- problemi tal- fwied bħal epatite
- swelling of breasts in men
- nefħa tas- sider fl- irġiel
- sleep disorders, abnormal dreams, confusion, disorientation, nervousness
- disturbi fl- irqad, ħolm anormali, konfużjoni, diżorjentament, nervi
- body changes associated with fat redistribution.
- tibdil fil- ġisem assoċċjat ma ’ ridistribuzzjoni tax- xaħam
HOW TO STORE INTELENCE
KIF TAĦŻEN INTELENCE
33 Do not use INTELENCE after the expiry date, which is stated on the carton and on the bottle after EXP.
Tużax INTELENCE wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq il- flixkun wara li JIS.
INTELENCE tablets should be stored in the original bottle.
Aħżen il- pilloli INTELENCE fil- flixkun oriġinali.
Keep the bottle tightly closed in order to protect from moisture.
Żomm il- flixkun magħluq sewwa sabiex tilqa ’ mill - umdita`.
The bottle contains 3 little pouches (desiccants) to keep the tablets dry.
Il- flixkun fih 3 qratas (desikkanti) sabiex iżommu l- pilloli xotti.
These pouches should stay in the bottle all the time and are not to be eaten.
Dawn il- qratas għandhom jibqgħu fil- flixkun il- ħin kollu u m’ għandhomx jittieklu.
What INTELENCE contains
X’ fih INTELENCE:
- The active substance is etravirine.
- Is- sustanza attiva hi etravirine.
Each tablet of INTELENCE contains 100 mg of etravirine.
Kull pillola INTELENCE fiha 100mg ta ’ etravirine.
- The other ingredients are hypromellose, microcrystalline cellulose, colloidal anhydrous silica,
- Is- sustanzi l- oħra huma hypromellose, microcrystalline cellulose, colloidal anhydrous silica,
croscarmellose sodium, magnesium stearate and lactose monohydrate.
croscarmellose sodium, magnesium stearate u lactose monohydrate.
What INTELENCE looks like and contents of the pack White to off-white, oval tablet, with “T125” on one side and “100” on the other side.
Pilloli ovali bojod jagħtu fl- offwajt, b ’ “ T125 ” fuq naħa u “ 100 ” fuq in- naħa l- oħra.
A plastic bottle containing 120 tablets and 3 pouches to keep the tablets dry.
Flixkun tal- plastik li fih 120 pillola u 3 qratas biex iżommu l- pilloli xotti.
Marketing Authorisation Holder Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Janssen- Cilag International NV, Turnhoutseweg 30, 2340 Beerse, il- Belġju
Manufacturer Janssen-Cilag SpA, Via C.
Manifattur Janssen- Cilag SpA, Via C.
Janssen, 0 4010 Borgo San Michele, Latina, Italy
Janssen, 04010 Borgo San Michele, Latina, l- Italja
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rapprezentant lokali tad - tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
This medicine has been given “conditional approval”.
Din il- mediċina ngħatat ‘ approvazzjoni b’ kondizzjoni ’.
This means that there is more evidence to come about this medicine.
Dan ifisser li għad trid tingħata aktar evidenza dwar din il- mediċina.
The European Medicines Agency (EMEA) will review new information on the medicine every year and this leaflet will be updated as necessary.
L- Aġenzija Ewropeja dwar il- Mediċini (EMEA) ser tirrevedi l- informazzjoni l- ġdida dwar il- mediċina kull sena u dan il- fuljett ser jiġi aġġornat, skond il- bżonn.
36
36 Informazzjoni ddettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /.
What is Intrinsa?
X’ inhu Intrinsa?
Intrinsa is a transdermal patch (a patch that delivers a medicine across the skin).
Intrinsa huwa roqgħa transdermali (roqgħa li tagħti mediċina minn ġol- ġilda).
The patch releases 300 micrograms of the active substance testosterone over 24 hours.
Ir- roqgħa tirrilaxxa 300 mikrogramma tas- sustanza attiva testosteronu fuq 24 siegħa.
What is Intrinsa used for?
Għalxiex jintuża Intrinsa?