qanastek/EMEA-V3 huggingface dataset:
However, at systemic plasma exposures significantly below (rabbits) or not significantly higher (rat) than the expected human exposures during therapeutic dosing, a number of minor changes, including
Dawn jindikaw li kien hemm
57 thymic elongation and minor skeletal variations were seen, indicating developmental delay.
Kien misjub li kien hemm żieda fil- piż tal- plaċenta fil- fenek u fil- far, li kienet marbuta skond ma ’ kemm tkun id- doża mogħtija.
A dose- dependent increase in placental weight was found in the rabbit and rat which may indicate effects on placental function.
Dan juri li jistà jkun hemm effett fuq il- funzjoni tal - plaċenta.
Propylene glycol, macrogol 400 (PEG 400), d-alpha tocopheryl polyethylene glycol 1000 succinate, acesulfame potassium, saccharin sodium, sodium chloride, artificial grape bubblegum flavour, natural peppermint flavour, menthol, citric acid, anhydrous, sodium citrate dihydrate, purified water.
Propylene glycol, macrogol 400 (PEG 400), d- alpha tocopheryl polyethylene glycol 1000 succinate, acesulfame potassium, saccharin sodium, sodium chloride, togħma ta ’ bubblegum ta ’ l- għeneb artifiċjali, togħma ta ’ peppermint naturali, menthol, citric acid, anhydrous, sodium citrate dihydrate, ilma ppurifikat.
Discard the oral solution 15 days after first opening the bottle.
Dak li jibqa mis- soluzzjoni orali 15- il ġurnata wara li jkun infetaħ il- flixkun, għandu jiġi mormi.
White High Density Polyethylene (HDPE) bottles containing 240 ml of oral solution.
Fliexkun abjad magħmul mil- propilin ta ’ densità għolja (HDPE) li fih 240 ml ta ’ soluzzjoni orali.
A 20 ml measuring cup is provided in the pack.
Fil - pakkett għandek issib ukoll tazza tal- kejl ta ’ 20 ml.
59 ANNEX II
61 ANNESS II
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Soft capsules • Glaxo Operations UK Limited, trading as Glaxo Wellcome Operations Priory Street, Ware, Hertfordshire SG12 ODJ, United Kingdom Manufacturing authorisation issued on 30 June 1995 by the Medicine Control Agency, Market Towers, 1 Nine Elms Lane, Vauxhall, London SW8 5NQ, United Kingdom.
Glaxo Operations UK Limited, fil- kummerċ Glaxo Wellcome Operations Triq Priory, Ware, Hertfordshire SG12 ODJ, Renju Unit L- awtorizzazzjoni tal- manifattura ġiet maħruġa fi 30 ta ’ Ġunju 1995 mill- Aġenzija tal - Kontroll tal- Mediċini, Market Towers, 1 Sqaq Nine Elms, Vauxhaull, Londra SW8 5NQ, Renju Unit.
• Glaxo Wellcome GmbH & Co.
Soluzzjoni Orali • Glaxo Wellcome GmbH & Co.
KG Industrie straße 32-36, 23843 Bad Oldesloe, Germany
KG Industrie straße 32- 36, 23843 Bad Oldesloe, Il- Ġermanja
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
Fuq il- fuljett ta 'tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal - manifattur responsabbli għall- ħruġ tal- lott konċernat
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ Prodott mediċinali jingħata b' riċetta ristretta tat- tabib (Ara Anness I:
LABELLING AND PACKAGE LEAFLET
• KUNDIZZJONIJIET OĦRA
LABELLING
Id- Detentur ta ’ l- awtorizzazzjoni għat- Tqegħid fis- Suq ikompli jissottometti Periodic Safety Update Reports kull sena.
63 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
63 ANNESS III
BOTTLE LABEL LEAFLET
TIKKETTA U FULJETT TA ’ TAGĦRIF
1.
64 A.
NAME OF THE MEDICINAL PRODUCT
FULJETT TAT- TIKKETTA TA ’ FUQ IL- FLIXKUN
Agenerase 50 mg soft capsules Amprenavir
Agenerase 50 mg kapsuli rotob Amprenavir
Each capsule contains 50 mg amprenavir
Kull kapsula fiha 50 mg amprenavir.
This product contains glycerol, sorbitol E420 and propylene glycol See leaflet for further information
Dan il- prodott fih glycerol, sorbitol E420 u propylene glycol Ara l- fuljett għal aktar informazzjoni
480 soft capsules
480 kapsuli rotob
Do not store above 30°C.
Taħżinx f’ temperatura 'l fuq minn 30°C
Keep the container tightly closed.
Żomm il- kontenitur magħluq sewwa
Glaxo Group Ltd Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom
Glaxo Group Ltd Glaxo Wellcome House Berkeley Avenue Middlesex UB6 ONN Renju Unit
LOT
Lott
65 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
67 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
BOTTLE LABEL LEAFLET
FULJETT TAT- TIKKETTA TA ’ FUQ IL- FLIXKUN
Agenerase 150 mg soft capsules Amprenavir
Agenerase 150 mg kapsuli rotob Amprenavir
Each capsule contains 150 mg amprenavir
Kull kapsula fiha 150 mg amprenavir.
240 soft capsules
240 kapsuli rotob
MARKETING AUTHORISATION NUMBER
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
69 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
This product contains glycerol, sorbitol E420 and propylene glycol See leaflet for further information
Dan il- prodott fih propylene glycol, potassium u sodium Ara l- fuljett għal aktar informazzjoni
Pack contents:
Kontenut tal- pakkett:
Two bottles each containing 240 soft capsules
Żewġt ifliexken, kull wieħed fih 240 kapsula ratba
69 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
71 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Agenerase 15 mg/ ml oral solution Amprenavir
Agenerase 15 mg/ ml soluzzjoni orali Amprenavir
This product contains propylene glycol, potassium and sodium See leaflet for further information
Dan il- prodott fih propylene glycol, potassium u sodium Ara l- fuljett għal aktar informazzjoni
Bottle contents:
Il- flixkun fih:
240 ml oral solution containing 15 mg/ ml amprenavir A 20 ml measuring cup is provided in the pack.
240 ml ta ’ soluzzjoni orali li fiha 15 mg/ ml ta ’ amprenavir Fil- pakkett għandek issib tazza tal- kejl ta ’ 20 ml.
Do not store above 25°C.
Taħżinx f’ temperatura 'l fuq minn 25°C
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTURTA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
71 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
73 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
LEAFLET
FULJETT
A 20 ml measuring cup is provided in the pack.
240 ml ta ’ soluzzjoni orali li fiha 15 mg/ ml ta ’ amprenavir Fil- pakkett għandek issib tazza tal- kejl ta ’ 20 ml.
72 9.
74 9.
74 PACKAGE LEAFLET:
76 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Agenerase 50 mg soft capsules Amprenavir
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Agenerase 50 mg, kapsuli rotob Amprenavir
Read all of this leaflet carefully before you start taking this medicine.
Aqra dan il- fuljett kollu qabel tibda tieħu din il- mediċina
• Keep this leaflet.
- Żomm dan il- fuljett.
It may harm them even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
1) What Agenerase is and what it is used for 2) Before you take Agenerase 3) How to take Agenerase 4) Possible side effects 5) How to store Agenerase 6) Further information
Aktar tagħrif
WHAT AGENERASE IS AND WHAT IT IS USED FOR
X’ INHU AGENERASE U GĦALXIEX JINTUŻA
Agenerase belongs to a group of antiviral medicines called protease inhibitors.
Agenerase jagħmel parti minn grupp ta ’ mediċini antivirali li jissejħu inibituri protease.
These medicines are used for treating human immunodeficiency virus (HIV) infection.
Dawn il - mediċini jintużaw fil- kura tal- vajrus tal- HIV.
Agenerase is used in protease inhibitor experienced HIV-1 infected adults and children above the age of 4 years.
Agenerase jintuża fl- adulti u tfal minn erbà snin ‘ il fuq, li huma infettati bl- HIV- 1 u li jkunu għamlu żmien taħt kura bil- inibituri protease.
Agenerase is prescribed for use in combination with other antiretroviral medicinal products.
Agenerase huwa preskritt sabiex jintuża flimkien ma ’ mediċini antiretrovirali oħra.
Your doctor will normally direct that Agenerase capsules should be taken with low doses of ritonavir to boost its efficacy.
Fil- biċċa l- kbira tal- każi t- tabib tiegħek ser jordnalek sabiex tieħu il- kapsuli ta ’ Agenerase flimkien ma ’ doża baxxa ta ’ ritonavir sabiex isaħħaħ l- effetti tiegħu.
The choice of Agenerase will be based on any resistance testing your doctor may have carried out and your treatment history.
It- tabib tiegħek jiddeċiedi jekk Agenerase huwiex tajjeb għalik wara li jkun għamel it- testijiet meħtieġa biex jara jekk hemmx xi reżistenza minn naħa tal- vajrus kif ukoll wara li jkun studja l- kura li tkun diġà ħadt.
The benefit of amprenavir boosted with ritonavir has not been demonstrated in PI naïve patients.
Ma ġiex muri li amprenavir flimkien ma ’ ritonavir huwa ta ’ benefiċċju f’ dawk il- pazjenti li qatt qabel ma jkunu rċevew kura bl- inibituri protease.
BEFORE YOU TAKE AGENERASE
QABEL MA TIEĦU AGENERASE
- if you are allergic (hypersensitive) to amprenavir or to any of the other ingredients in
Tieħux Agenerase: - jekk inti allerġiku (tbati minn sensittivita ’ eċċessiva) għal amprenavir jew sustanzi oħra ta ’ Agenerase
Agenerase.
- jekk inti tbati minn ħsara serja jew kbira fil- fwied.
- if you have severe liver disease (see ‘ Take special care with Agenerase’).
(ara ‘ Oqgħod attent ħafna b’ Agenerase).
- you are currently taking any of the following medicines:
- jekk qed tieħu xi waħda minn dawn il- mediċini:
- astemizole or terfenadine (commonly used to treat allergy symptoms – these medicines may
- astemizole jew terfenadine (li s- soltu jintużaw biex jikkuraw s- sintomi ta ’ l- allerġiji
be available without prescription)
– dawn il- mediċini tista ssibhom mingħajr riċetta)
- pimozide (used to treat schizophrenia)
- pimozide (li jintuża biex jikkura l- iskiżofrenija)
- cisapride (used to relieve certain stomach problems)
- cisapride (li jintuża biex jalleva ċerti problemi fl- istonku)
- ergot derivatives (used to treat headaches)
- derivati ergot (li jintużaw biex jikkuraw l- uġigħ ta 'ras)
- rifampicin (used to treat tuberculosis)
- rifampicin (li jintużaw biex jikkuraw it- tuberkulożi)
- amiodarone, quinidine (used to treat abnormal heart beat)
- amiodarone, quinidine (li jintużaw biex jikkuraw battitu mhux normali tal- qalb)
- flecainide and propafenone (heart medicines)
- flecainide u propafenone (mediċini tal- qalb)
- triazolam and oral (taken by mouth) midazolam (used to help you sleep and / or relieve
- triazolam u midazolam orali (jittieħed mill- ħalq) (jintużaw biex jgħinuk torqod u /
anxiety)
jew biex itaffu l- ansjeta ’)
- bepridil (used to treat hypertension).
- bepridil (li jintuża biex jikkura l- pressjoni għolja)
- if you are currently taking any products containing St John’ s wort (Hypericum perforatum) as
77 - jekk qed tieħu mediċini li fihom St John’ s Wort (Hypericum perforatum) għax dawn jistgħu itellfu lil Agenerase milli jaħdem kif suppost (ara ‘ Qabel ma tieħu/ tuża mediċini oħra).
Tell your doctor if you have any of these listed conditions, or are taking any of the medicines listed above.
Għid lit- tabib tiegħek jekk tbati minn dawn il- kundizzjonijiet imsemmija, jew qed tieħu xi mediċini msemmija hawn fuq
Take special care with Agenerase You will need to take Agenerase every day.
Inti tkun trid tieħu Agenerase kuljum.
This medicine helps to control your condition, but it is not a cure for HIV infection.
Din il- mediċina tgħin sabiex trażżan il- marda tiegħek iżda mhix kura li tfejjaq infezzjoni tal- HIV.
You can still continue to develop other infections and other illnesses associated with HIV disease.
Inti xorta tista tiżviluppa infezzjonijiet u mard ieħor li huma assoċjati mal- marda tal- HIV.
You should keep in regular contact with your doctor.
Għandek tibqà żżomm kuntatt regolari mat- tabib tiegħek.
Do not stop taking your medicine without first talking to your doctor.
Qatt ma għandek twaqqaf din il- mediċina mingħajr ma ’ qabel tkellem lit- tabib tiegħek.
If your doctor has recommended that you take Agenerase capsules together with low doses of ritonavir, used to boost its activity, then please make sure that you carefully read the ritonavir Package Leaflet before starting therapy.
Jekk it- tabib tiegħek ordnalek biex tieħu l- kapsuli ta ’ Agenerase flimkien ma ’ doża baxxa ta ’ ritonavir sabiex isaħħaħ l- effett tagħhom, għandek tkun żgur li qabel tibda taqra l- fuljett ta ’ tagħrif ta ’ ritonavir.
At present, there is insufficient information to recommend the use of Agenerase in children less than four years of age.
Bħalissa m’ hemmx tagħrif biżżejjed sabiex wieħed jirrikmanda l- użu ta ’ Agenerase fi tfal iżgħar minn erbà snin.
There is also insufficient information to recommend the use of Agenerase capsules boosted with ritonavir in children of 4 to 12 years of age or any patients weighing less than fifty kilograms.
Hekk ukoll m’ hemmx tagħrif biżżejjed sabiex wieħed jirrikmanda l- użu tal- kapsuli ta ’ Agenerase flimkien ma ’ ritonavir fi tfal ta ’ bejn l- erbà u tnax- il sena jew f’ pazjenti li jiżnu anqas minn ħamsin kilogramm.
Agenerase may interact with other medicines that you are taking, so it is important that you read the next section “ Taking/ using other medicines” before taking this medicine.
Għalhekk huwa mportanti ħafna li qabel tibda tieħu din il- mediċina taqra sewwa l- parti li jmiss ta ’ dan il- fuljett imsejħa “ Użu ta ’ mediċini oħra ”.
You should tell your doctor about any medical conditions that you have or have had.
Inti għandek dejjem tavża lit- tabib tiegħek dwar xi mard li inti għandek jew li setà kellek qabel.
- Please speak with your doctor if you have a history of liver disease.
- Kellem lit- tabib tiegħek jekk inti kont jew qed tbati minn mard fil- fwied.
Patients with chronic
Pazjenti li huma morda
hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal liver adverse events and may require blood tests for control of liver function.
kroniċi bl- epatite B jew Ċ u li jingħataw mediċini antiretrovirali ikunu f’ riskju akbar li jsofru minn effetti mhux mixtieqa fil- fwied li jkunu serji u ta ’ periklu għal ħajjithom.
- The use of Agenerase together with ritonavir has not been studied in patients with liver disease.
- L- użu flimkien ta ’ Agenerase u ritonavir f’ pazjenti li jbatu minn mard fil- fwied għadu qatt ma ’
If your liver disease is severe you must not use this combination.
Jekk inti tbati minn mard serju fil- fwied m’ għandek qatt tuża dawn il- mediċini flimkien.
- Agenerase capsules (without the boosting effect of ritonavir) have been studied in patients with
- L- użu tal- kapsuli ta ’ Agenerase (iżda mhux flimkien ma ’ ritonavir) ġie studjat f’ pazjenti li jbatu
liver impairment.
minn ħsara fil- fwied.
If you suffer from liver disease and your doctor decides to use unboosted Agenerase capsules (that is without ritonavir), the dose of Agenerase may need to be adjusted.
Jekk inti tbati minn mard fil- fwied u t- tabib tiegħek jiddeċiedi li għandu jtik il- kapsuli ta ’ Agenerase (iżda mhux flimkien ma ’ ritonavir) jista jkun hemm xi tibdil fid- doża li inti ser tingħata.
- There have been reports of increased bleeding in patients with haemophilia taking protease
- Kien hemm każi fejn ġiet irrapurtata żieda fil- fsada f’ pazjenti li jsofru mill- emofilja u li kienu qed
inhibitors.
jieħdu l- inibituri protease.
The reason for this is not known.
Ir- raġuni għalfejn seħħ dan ma saritx magħrufa.
You may need additional factor VIII to control bleeding.
Jistà jkun li tkun tinħtieġ aktar factor VIII sabiex twaqqaf din il- fsada.
- Redistribution, accumulation or loss of body fat may occur in patients receiving combination
- Jistà jkun hemm taqsim mod ieħor, żieda jew telf fix- xaħam tal- ġisem f’ dawk li qed jieħdu taħlita
antiretroviral therapy.
ta ’ mediċini antiretrovirali.
Contact your doctor if you notice changes in body fat.
Kellem lit- tabib tiegħek jekk tara xi tibdil fix- xaħam ta ’ ġismek.
- In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection,
- F’ xi pazjenti b’ infezzjoni avvanzata ta ’ l- HIV (AIDS), u li kellhom infezzjonijiet opportunistiċi
signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
fil- passat, jistgħu joħorġu sinjali u sintomi ta ’ infjammazzjoni minn infezzjonijiet ta ’ qabel ftit wara li jinbeda it- 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 mifhum li dawn is- sintomi huma minħabba titjib fis- sistema immuni tal- ġisem, li tħalli lil- ġisem jiġġieled l- infezzjonijiet li setgħu kienu hemm mingħajr ma kienu qed jagħtu sintomi.
If you notice any symptoms of infection, please inform your doctor immediately.
Jekk tinnota xi sintomi ta ’ infjammazzjoni, jekk jogħġbok informa lit- tabib tiegħek mill- ewwel.
- If you have any other health concerns, discuss these with your doctor.
- Jekk tħossok inkwetat dwar xi problemi oħra ta ’ saħħa li jistà jkollok tkellem mat- tabib tiegħek.
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 Xi pazjenti li jieħdu terapija antiretrovirali kombinata jistgħu jiżviluppaw marda ta ’ l- għadam li tissejjaħ ostejonekrożi (il- mewt tat- tessut ta ’ l- għadam minħabba nuqqas ta ’ ċirkolazzjoni għall - 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.
Sinjali ta ’ ostejonekrożi huma egħbusija tal- ġogi,
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
78 uġigħ (speċjalment fil- ġenb, l- irkoppa u l- ispalla) u diffikultà biex tiċċaqlaq.
If you notice any of these symptoms please inform your doctor.
Jekk tinnota xi wieħed minn dawn is- sintomi jekk jogħġbok għarraf lit- tabib tiegħek.
76 Treatment with Agenerase has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer.
Il- kura b’ Agenerase ma tnaqqasx ir- riskju li wieħed ixerred l- HIV permezz ta ’ kuntatti sesswali jew permezz tad- demm.
You should continue to use appropriate precautions to prevent this.
Għalhekk għandek dejjem tibqa tieħu kull prekawzjoni possibbli sabiex dan ma jseħħx.
Taking/ using other medicines Before starting treatment with Agenerase, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu / tuża mediċini oħra Qabel tibda tieħu Agenerase, jekk jogħġbok għarraf lit- tabib jew spiżjar tiegħek jekk qed tieħu, jew ħadt dan l- aħħar, xi mediċini oħra, anki dawk bla riċetta tat- tabib.
This is very important, as taking some types of medicines at the same time as Agenerase can strengthen or weaken the effect of the medicines.
Dan huwa importanti ħafna minħabba li meta xi mediċini jittieħdu fl- istess waqt ma ’ Telzir u ritonavir dan jistà jwassal għal żieda jew nuqqas fl- effett li dawn il- mediċini jista ’ jkollhom.
This can sometimes lead to serious medical conditions.
Dan kultant jista ’ jwassal għal kondizzjonijiet medikali serji.
There are some medicines that you must not take with Agenerase (please see ‘ Do not take Agenerase’ for further information).
Hemm xi mediċini li m’ għandekx tieħu flimkien ma ’ Telzir (jekk jogħġbok ara ‘ Tieħux Telzir ’ għal aktar informazzjoni)
Agenerase may interact with certain other medicines.
Agenerase jista ma jaqbilx ma ’ xi mediċini oħrajn.
The use of the following medicines, together with Agenerase, should only take place on the basis of medical advice: anaesthetics (e. g. lidocaine), antibiotics (e. g. rifabutin, clarithromycin, dapsone and erythromycin), antifungals (e. g. ketoconazole, itraconazole), antimalarials (e. g. halofantrine), anticonvulsant medicines (e. g. carbamazepine, phenytoin and phenobarbital), calcium channel blockers (e. g. amlodipine, diltiazem, felodipine, isradipine, nicardipine, nifedipine, nimodipine, nisoldipine and verapamil), cholesterol lowering medicines (e. g. atorvastatin, lovastatin and simvastatin), erectile dysfunction medicines (e. g. sildenafil and vardenafil), non-nucleoside reverse transcriptase inhibitors (e. g. delavirdine, efavirenz and nevirapine), opioids (e. g. methadone), hormones like oestrogens and progestogens (e. g. hormonal contraceptives such as the ‘ pill’), some glucocorticoids (e. g. fluticasone propionate and budesonide), tricyclic antidepressants (e. g. desipramine and nortriptyline), sedative agents (e. g. midazolam administered by injection), and others (e. g. clozapine and loratadine).
M’ għandekx tieħu l- mediċini li ġejjin flimkien ma ’ Agenerase sakemm mhux bl- ordni tat- tabib tiegħek: anestetiċi (i. e. lidocaine), antibijotiċi (i. e. rifabutin, clarithromycin, dapsone u erythromycin), antifungi (i. e ketoconazole, itraconazole), antimalarji (i. e. halofantrine), mediċini antikonvulsivi (i. e. carbamazepine, phenytoin, u phenobarbital), imblokkaturi tal- kanali tal- kalċju (eż amlopidine, diltiazem, felopidine, isradipine, nicarpidine, nifepidine, nimodipine, nisolpidine u verapamil) mediċini li jbaxxu l- kolesterol (i. e. atorvastatin, lovastatin u simvastatin), mediċini għal problemi fl- erezzjoni (i. e. sildenafil u vardenafil), impedituri reverse transcriptase mhux nuklejosidi (i. e. delavirdine, efavirenz u nevirapine), opjojdi (i. e. methadone), ormoni bħal estroġeni u proġestoġeni (eż kontraċettivi ormonali bħall - ‘ pillola ’), xi glukokortikojdi( i. e. fluticasone propionate u budesonide), antidepressanti triċikliċi (i. e desipramine u notriptyline), sustanzi sedattivi (i. e. midazolam meta jingħata fil- vina), u oħrajn (i. e. clozapine, u loratadine).
If you are taking certain medicines that can cause serious side effects, such as carbamazepine, phenobarbital, phenytoin, lidocaine, cyclosporine, tacrolimus, rapamycin, tricyclic antidepressants and warfarin, at the same time as you are taking Agenerase, your doctor may carry out additional blood tests to minimise any potential safety problems.
Jekk qed tieħu mediċini li jistgħu jikkawżaw effetti mhux mixtieqa li huma serji, bħal carbamezapine, phenobarbital, phenytoin, lidocaine, cyclosporin, tacrolimus, rapamycin, antidipressanti triċikliċi u warfarin, fl- istess ħin ma ’ Agenerase, it- tabib tiegħek jista ’ jkollu bżonn jagħmel testijiet oħra tad - demm sabiex jevita kemm jista ’ jkun problemi ta ’ sigurtà tas- saħħa li jistgħu jinqalgħu.
If you are taking the contraceptive pill, it is recommended that you use an alternative method (e. g. a condom) to prevent pregnancy while you are taking Agenerase.
Jekk qed tieħu l- pillola kontraċettiva huwa rrakkomandat li tuża metodi oħra mhux ormonali ta ’ kontraċezzjoni (bħal kondom) biex tevita t- tqala waqt li tkun qed tieħu Agenerase.
The concomitant use of Agenerase and contraceptive pill may result in a decrease of the therapeutic effect of Agenerase.
L- użu flimkjen ta ’ Agenerase u l- pillola kontraċettiva jista ’ jwassal għal nuqqas fl- effett terapewtiku ta 'Agenerase.
Taking Agenerase with food and drink Agenerase capsules should be swallowed whole with water or another drink.
Meta tieħu Agenerase ma ’ l- ikel u max- xorb Il- pilloli ta ’ Telzir għandek tiblagħhom sħaħ bl- ilma jew xorb ieħor.
They can be taken with or without food.
Jistgħu jittieħdu ma ’ jew mingħajr ikel.
Pregnancy and breast-feeding Inform your doctor if you are pregnant or planning to become pregnant soon.
Tqala u Treddigħ Kellem lit- tabib tiegħek jekk inti tqila jew għandek ħsieb li tinqabad tqila dalwaqt.
The safe use of Agenerase in pregnancy has not been established.
Is- sigurtà ta ’ Agenerase waqt it- tqala mhix magħrufa.
Ask your doctor or pharmacist before taking any medicine.
Staqsi lit- tabib jew lill- ispiżjar tiegħek qabel ma tieħu xi mediċina.
Breast feeding your baby is not recommended while you are taking Agenerase.
M’ għandekx treddà lit- tarbija tiegħek waqt li qed tieħu Agenerase.
It is recommended that HIV positive women do not breast feed their infants in order to avoid transmission of HIV.
Huwa rakkomandat li nisa li huma HIV positive ma jreddgħux lit- trabi tagħhom u dan sabiex jevitaw it- tixrid tal- HIV.
Driving and using machines No studies on the effects of Agenerase on the ability to drive and use machines have been done.
Sewqan u tħaddim ta ’ magni Ma sar l- ebda studju fuq l- effett li jista jkollu Agenerase fuq min isuq, juża għodda jew iħaddem magni.
If Agenerase makes you dizzy, do not operate any tools or machines.
Agenerase iqabbdek sturdament, m’ għandekx tagħmel użu minn għodda jew tħaddem magni
Important information about ingredients of Agenerase capsules These capsules contain glycerol, which can cause adverse effects in high doses.
Din tistà twassal għal effetti mhux mixtieqa jekk tittieħed doża għolja izjed mis- soltu.
Glycerol can cause headache, stomach upset and diarrhoea.
Glycerol jista jikkawża uġigħ ta ’ ras, taqlib fl- istonku u dijarea.
These capsules also contain sorbitol.
Dawn il- kapsuli fihom ukoll is- sorbitol.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product
Jekk it- tabib tiegħek qallek li ma jaqblux miegħek xi tipi ta ’ zokkor, ikkuntatja lit- tabib tiegħek qabel ma ’ tieħu dan il- prodott mediċinali.
77 Because Agenerase capsules contain vitamin E, you should not take additional vitamin E supplements.
Minħabba li l- kapsuli ta ’ Agenerase fihom il- vitamina E, m’ għandekx tieħu xi vitamini oħra li fihom il- vitamina E.
HOW TO TAKE AGENERASE
KIF GĦANDEK TIEĦU AGENERASE
Always take Agenerase exactly as your doctor has told you.
Dejjem għandek tieħu Agenerase skond ma ’ jgħidlek it- tabib tiegħek.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew spiżjar tiegħek jekk ikollok xi dubju.
If you need to take an antacid for indigestion, or if you are taking a drug containing an antacid (e. g. didanosine), you are advised to take it more than an hour before or after Agenerase, otherwise the effects of Agenerase may be reduced.
Jekk ikollok bżonn tieħu mediċini kontra l- aċidu fl- istonku jew xi mediċina li fiha hemm mediċina oħra għal kontra l- aċidu fl- istonku (bħal didanosine), inti għandek teħodha ta ’ l- anqas siegħa qabel jew wara li tkun ħadt Agenerase.
- Swallow Agenerase capsules whole with water or another drink.
- Għandek tiblà il- kapsuli ta ’ Agenerase sħaħ flimkien ma ’ tazza ilma jew xi xarba oħra.
They can be taken with or
Tistà
without food.
tieħu l- kapsuli kemm ma ’ l- ikel kif ukoll waħidhom.
- Adults and adolescents (of 12 years of age and older) (greater than 50 kg body weight): the
- Adulti u adoloxxenti minn 12- il sena ‘ l fuq (piż tal- ġisem aktar minn 50kg): id- doża normali ta ’
If your doctor decides it is inappropriate for you to take ritonavir, you will need to take increased doses of Agenerase (1200 mg twice a day).
kapsuli ta ’ Agenerase hija ta ’ 600 mg darbtejn kuljum flimkien ma ’ 100 mg ritonavir darbtejn kuljum, flimkien ma ’ mediċini antiretrovirali oħra. Jekk it- tabib tiegħek jiddeċiedi li jkun aħjar jekk inti ma ’ tieħux ritonavir, inti jkollok bżonn tieħu doża akbar ta ’ Agenerase (1200 mg darbtejn kuljum).
- Children (4 to 12 years) and patients less than 50 kg body weight: the dose will be calculated
- Tfal (minn 4 sa 12- il sena) u pazjenti li għandhom piż tal- ġisem inqas minn 50kg: id- doża
according to your weight by your doctor.
meħtieġa tiġi maħduma mit- tabib tiegħek skond il- piż tiegħek.
The usual dose for Agenerase capsules is 20 mg for each kg of body weight, twice a day.
Id- doża normali ta ’ kapsuli ta ’ Agenerase hija ta ’ 20 mg għal kull kilogramm ta ’ piż tal- gisem darbtejn kuljum.
You should not take more than 2400 mg per day.
Qatt m’ għandek tieħu aktar minn 2400 mg kuljum.
In some cases, your doctor may adapt the dose of Agenerase when other drugs are administered concomitantly with Agenerase.
F’ xi każi fejn jingħataw mediċini oħra flimkien ma ’ Agenerase, it- tabib tiegħek jistà jbiddel id- doża ta ’ Agenerase.
To derive the full benefit of Agenerase, it is very important that you take the full daily dose prescribed by your doctor.
Sabiex inti tgawdi mill- benefiċċji kollha ta ’ Agenerase, huwa mportanti ħafna li inti tieħu d- doża kollha hekk kif ordnat mit- tabib tiegħek.
An oral solution of Agenerase is available for children or adults unable to swallow capsules.
Teżisti soluzzjoni orali ta ’ Agenerase li hija tajba għat- tfal jew għal dawk il- kbar li m’ humiex kapaċi jibilgħu l- kapsuli.
If you take more Agenerase than you should If you have taken more than the prescribed dose of Agenerase, you should contact your doctor or pharmacist immediately for advice.
Jekk tieħu Agenerase aktar milli suppost Jekk ħadt aktar Agenerase minn kemm ordnalek it- tabib, għandek tkellem lit- tabib jew spiżjar tiegħek minnufih.
If you forget to take Agenerase If you forget to take a dose of Agenerase, take it as soon as you remember and then continue as before.
Jekk tinsa tieħu xi doża ta ’ Agenerase għandek teħodha hekk kif tiftakar.
Do not take a double dose to make up for a forgotten dose.
Wara tistà tkompli bħal qabel.
If you stop taking Agenerase You must not stop taking Agenerase without consulting your doctor.
Jekk tieqaf tieħu Agenerase M’ għandekx tieqaf tieħu Agenerase mingħajr ma tistaqsi lit- tabib tiegħek.
Like all medicines, Agenerase can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Agenerase jista ’ jagħmel effetti mhux mixtieqa, għalkemm mhux kulħadd ikollu.
When treating HIV infection, it is not always possible to tell whether some of the undesirable effects that occur are caused by Agenerase, by other medicines taken at the same time or by the HIV disease.
Waqt il- kura ta ’ infezzjonijiet bl- HIV mhux dejjem ikun possibbli li wieħed jgħid jekk xi effetti mhux mixtieqa li jinħassu jkunux ġejjin minħabba Agenerase jew minħabba xi mediċina oħra li tkun qed tingħata jew mill- marda tal- HIV nfisha.
For this reason, it is very important that you inform your doctor about any changes in your health.
Għalhekk jekk tħoss xi tibdil fis- saħħa tiegħek għandek tkellem lit- tabib tiegħek.
Very common side effects (these can affect more than 10 in 100 patients treated)
Effetti mhux mixtieqa komuni ħafna (dawn jistgħu jaffettwaw aktar minn 10 f’ 100 pazjent trattat)
Diarrhoea, feeling sick, vomiting, flatulence Skin Rashes (red, raised or itchy) – Occasionally, the skin rash may be severe and you may have to stop taking this medicine.
• Uġigħ ta ’ ras, tħossok għajjien • Diareja, tħossok imqalla, rimettar, gass Raxx fil- Ġilda (ħamra, mtella jew bil- ħakk) - Xi drabi r- raxx fil- ġilda jistà jkun qawwi u inti jkollok bżonn twaqqaf din il- mediċina.
Common side effects (these can affect 1 to 10 in 100 patients treated)
Effetti mhux mixtieqa komuni (dawn jistgħu jaffettwaw minn 1 sa 10 f’ 100 pazjent trattat)
Increases in triglycerides (a type of blood fat), changes in body shape because of fat redistribution,
Żieda fit- triglycerides (tip ta ’ xaħam fid- demm), bidla fis- sura tal- ġisem minħabba distribuzzjoni differenti tax- xaħam.
Moodiness, depression, difficulty sleeping, loss of appetite Tingling or numbness around the lips and mouth, uncontrolled movements Pain, discomfort or excess acid in the stomach, loose stools, Increases in enzymes produced by the liver called transaminases, increases of an enzyme produced by the pancreas called amylase
Taqlib fil- burdata, dipressjoni, diffikulta fl- irqad, nuqqas ta ’ aptit Textix u tnemnim madwar ix- xuftejn u l- ħalq, ċaqlieq bla kontroll Uġigħ, skomdu jew aċtu żejjed fl- istonku, ippurgar maħlul Żieda fl- enżimi li jipproduċi l- fwied li jissejħu transaminases, żieda f- enżima li tipproduċi l - frixa li tissejaħ amylase
Uncommon side effects (these can affect less than 1 in 100 patients treated)
Effetti mhux mixtieqa mhux komuni (dawn jistgħu jaffettwaw anqas minn 1 f’ 100 pazjent trattat)
Increases in blood sugar or cholesterol (a type of blood fat) Increases in the blood of a substance called bilirubin Swelling of the face, lips and tongue (angioedema)
Żieda fiz- zokkor fid- demm jew fil- kolesterol (tip ta; xaħam fid- demm) Żieda fid- demm ta ’ sustanza li tissejjaħ bilirubin Nefħa fil- wiċċ, ix- xuftejn u l- ilsien (anġjoedema)
effects (these can affect 1 in 1,000 patients treated)
Effetti mhux mixtieqa rari (dawn jistgħu jaffettwaw 1 f’ 1000 pazjent trattat)
A severe or life-threatening skin reaction (Stevens Johnson syndrome)
Reazzjoni fil- ġilda qawwija jew ta ’ periklu għall- ħajja (sindromu ta ’ Stevens Johnson)
Other possible effects
Effetti mhux mixtieqa oħrajn li jistgħu jiġru
In patients with haemophilia Type A and B, there have been reports of increased bleeding while taking protease inhibitors.
F’ dawk il- pazjenti li jbatu minn emofilija tip A u B kien hemm rapporti ta ’ żieda fil- fsada waqt l- użu tal- inibituri protease.
Should this happen to you, seek immediate advice from your doctor.
Jekk dan jiġri lilek, kellem lit- tabib tiegħek immedjatament.
There have been reports of muscle pain, tenderness or weakness, particularly with antiretroviral therapy including protease inhibitors and nucleoside analogues.
Ġew irrapurtati każi ta ’ uġigħ jew indebboliment fil- muskoli, l- aktar f’ kura antiretrovirali permezz ta ’ inibituri protease u analogi tan- nuklejosajd.
On rare occasions, these muscle disorders have been serious (rhabdomyolysis).
F’ okkażjonijiet rari dawn kienu ta ’ natura serja (rhabdomyolysis).
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
It- terapija kombinata antiretrovirali tistà twassal għal tibdil fis- sura tal- ġisem minħabba lipodistrofija.
These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘buffalo hump’).
Dan it- tibdil jinkludi telf ta ’ xaħam mis- saqajn, mill- idejn u mill- wiċċ, żieda ta ’ xaħam addominali (maż- żaqq) u ma ’ organi interni oħra tal- ġisem, tkabbir tas- sider u ħotba ta ’ xaħam fuq wara tal- għonq (buffalo hump).
The cause and long-term health effects of these conditions are not known at this time.
Il- kawża u l- effetti fit- tul fuq is- saħħa tal- pazjenti ta ’ dan it- tibdil għadhom mhux magħrufa.
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.
It- terapija kombinata antiretrovirali tistà twassal għal żieda fl- aċidu laktiku u fiz- zokkor fid - demm, żieda ta ’ xaħam fid- demm u reżistenza għall- insulina.
If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE AGENERASE
KIF TAĦŻEN AGENERASE
Do not store above 30o C.
Taħżinx f’ temperatura 'l fuq minn 30°C.
Keep the container tightly closed, in order to protect from moisture.
Żomm il- kontenitur magħluq sewwa sabiex tilqa ’ mill - umdità.
Do not use Agenerase after the expiry date which is stated on the carton.
M’ għandekx tuża Agenerase wara d- data li jiskadi li tidher fuq il- kartuna.
What Agenerase contains
X’ fih Agenerase
The active substance is amprenavir Each Agenerase capsule contains 50 mg of amprenavir.
Is- sustanza attiva hi amprenavir Kull kapsula ratba fiha 50 mg ta ’ amprenavir
The other ingredients within the capsule are d-alpha tocopheryl polyethylene glycol 1000 succinate (TPGS), macrogol 400 (polyethylene glycol 400) and propylene glycol.
Sustanzi oħra fil- kapsula jinkludu d- alpha tocopheryl polyethylene glycol 1000 succinate (TPGS), macrogol 400 (polyethylene glycol 400) u propylene glycol.
The capsule shell contains gelatin, glycerol, d-sorbitol and sorbitans solution, titanium dioxide and red printing ink.
Il- qoxra tal- kapsula fiha gelatin, glycerol, taħlita likwida ta ’ d- sorbitol u sorbitans, titanium dioxide, red printing ink.
What Agenerase looks like and contents of the pack
Id- Dehra ta ’ Agenerase u l- kontenuti tal- pakkett:
Agenerase 50 mg soft capsules are supplied in plastic bottles containing 480 soft capsules.
Agenerase 50 mg kapsuli rotob jiġu fi fliexken li kull wieħed fih 480 kapsula ratba.
These soft capsules are oblong, opaque, off white to cream in colour and marked with the code GX CC1.
Dawn il- kapsuli rotob għandhom forma rettangolari, huma opaki b’ lewn abjad maħmuġ jkanġi għall- krema u stampati bl- ittri GX CC1.
Marketing Authorisation Holder
Sid l- Awtorizzazzjoni għall- kummerċ
Glaxo Wellcome Operations Priory Street Ware Hertfordshire SG12 ODJ United Kingdom
KG Industriestrasse 32- 36 23843 Bad Oldesloe Ġermanja
Glaxo Group Ltd Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 ONN United Kingdom
Glaxo Group Ltd Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 ONN Renju Unit
For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tad- Detentur ta ’ l- Awtoriżżazzjoni għat- tqegħid fis- Suq.
België/Belgique/Belgien GlaxoSmithKline s.a./n.v.
82 Luxembourg/ Luxemburg België/ Belgique/ Belgien GlaxoSmithKline s. a. / n. v.
81 PACKAGE LEAFLET:
84 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Agenerase 150 mg soft capsules Amprenavir
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Agenerase 150 mg, kapsuli rotob Amprenavir
Do not pass it on to others.
Tista ’ tagħmlilhom il -
1) What Agenerase is and what it is used for.
X’ inhu Agenerase u għalxiex jintuża 2.
2) Before you take Agenerase 3) How to take Agenerase 4) Possible side effects 5) How to store Agenerase 6) Further information
Aktar tagħrif
Agenerase is used in protease inhibitor experienced HIV-1 infected adults and children above the age of 4 years.
Agenerase jintuża fl- adulti u tfal minn erbà snin ‘ il fuq, li huma infettati bl- HIV- 1 u li jkunu għamlu żmien taħt kura bl- inibituri protease.
- if you have severe liver disease (see ‘Take special care with Agenerase’).
(ara Oqgħod attent ħafna b’ Agenerase)
- you are currently taking any of the following medicines:
jekk qed tieħu xi waħda minn dawn il- mediċini:
- if you are currently taking any products containing St John’s wort (Hypericum perforatum) as
- jekk qed tieħu mediċini li fihom St John’ s Wort( Hypericum perforatum) għax dawn jistgħu itellfu lil Agenerase milli jaħdem kif suppost (ara ‘ Qabel ma tieħu/ tuża mediċini oħra).
this may stop Agenerase from working properly (see Taking/using other medicines).
Għid lit- tabib tiegħek jekk tbati minn dawn il- kundizzjonijiet imsemmija, jew qed tieħu xi mediċini msemmija hawn fuq
Tell your doctor if you have any of these listed conditions, or are taking any of the medicines listed above.
Oqgħod attent ħafna b’ Agenerase:
Agenerase may interact with other medicines that you are taking, so it is important that you read the next section “Taking/using other medicines” before taking this medicine.
Għalhekk huwa mportanti ħafna li qabel tibda tieħu din il- mediċina taqra sewwa l- parti li jmiss ta ’ dan il- fuljett imsejħa “ Użu ta ’ mediċini oħra ”.
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 mifhum li dawn is- sintomi huma minħabba titjib fis- sistema immuni tal- ġisem, li tħalli lil- ġisem jiġġieled l- infezzjonijiet li setgħu kienu hemm mingħajr ma kienu qed jagħtu sintomi.
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 tat- terapija antiretrovirali kombinata, l- użu ta ’ kortikosterojdi, il- konsum ta ’ alkoħol,
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Sinjali ta ’ ostejonekrożi huma għebusija tal- ġogi, uġigħ (speċjalment fil- ġenb, l- irkoppa u l- ispalla) u diffikultà biex tiċċaqlaq.
83 Treatment with Agenerase has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer.
Il- kura b’ Agenerase ma tnaqqasx ir- riskju li wieħed ixerred l- HIV permezz ta ’ kuntatti sesswali jew permezz tad- demm.
Taking/using other medicines Before starting treatment with Agenerase, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu / tuża mediċini oħra Qabel tibda tieħu Agenerase, jekk jogħġbok għarraf lit- tabib jew spiżjar tiegħek jekk qed tieħu, jew ħadt dan l- aħħar, xi mediċini oħra, anki dawk bla riċetta tat- tabib.
There are some medicines that you must not take with Agenerase (please see ‘Do not take Agenerase’ for further information).
Hemm xi mediċini li m’ għandekx tieħu flimkien ma ’ Telzir (jekk jogħġbok ara ‘ Tieħux Telzir ’ għal aktar informazzjoni)
The use of the following medicines, together with Agenerase, should only take place on the basis of medical advice: anaesthetics (e.g. lidocaine), antibiotics (e.g. rifabutin, clarithromycin, dapsone and erythromycin), antifungals (e.g. ketoconazole, itraconazole), antimalarials (e.g. halofantrine), anticonvulsant medicines (e.g. carbamazepine, phenytoin and phenobarbital), calcium channel blockers (e.g. amlodipine, diltiazem, felodipine, isradipine, nicardipine, nifedipine, nimodipine, nisoldipine and verapamil), cholesterol lowering medicines (e.g. atorvastatin, lovastatin and simvastatin), erectile dysfunction medicines (e.g. sildenafil and vardenafil), non-nucleoside reverse transcriptase inhibitors (e.g. delavirdine, efavirenz and nevirapine), opioids (e.g. methadone), hormones like oestrogens and progestogens (e.g. hormonal contraceptives such as the ‘pill’), some glucocorticoids (e.g. fluticasone propionate and budesonide), tricyclic antidepressants (i.e. desipramine and nortriptyline), sedative agents (e.g. midazolam administered by injection), and others (e.g. clozapine and loratadine).
M’ għandekx tieħu l- mediċini li ġejjin flimkien ma ’ Agenerase sakemm mhux bl- ordni tat- tabib tiegħek: anestetiċi (i. e. lidocaine), antibijotiċi (i. e. rifabutin, clarithromycin, dapsone u erythromycin), antifungi (i. e ketoconazole, itraconazole), antimalarji (i. e. halofantrine), mediċini antikonvulsivi (i. e. carbamazepine, phenytoin, u phenobarbital), imblokkaturi tal- kanali tal- kalċju (eż amlopidine, diltiazem, felopidine, isradipine, nicarpidine, nifepidine, nimodipine, nisolpidine u verapamil) mediċini li jbaxxu l- kolesterol (i. e. atorvastatin, lovastatin u simvastatin), mediċini għal problemi fl- erezzjoni (i. e. sildenafil u vardenafil), impedituri reverse transcriptase mhux nuklejosidi (i. e. delavirdine, efavirenz u nevirapine), opjojdi (i. e. methadone), ormoni bħal estroġeni u proġestoġeni (eż kontraċettivi ormonali bħall - ‘ pillola ’), xi glukokortikojdi( i. e. fluticasone propionate u budesonide), antidepressanti triċikliċi (i. e desipramine u notriptyline), sustanzi sedattivi (i. e. midazolam meta jingħata fil- vina), u oħrajn (i. e. clozapine, u loratadine).
If you are taking the contraceptive pill, it is recommended that you use an alternative method (e.g. a condom) to prevent pregnancy while you are taking Agenerase.
Jekk qed tieħu l- pillola kontraċettiva huwa rrakkomandat li tuża metodi oħra mhux ormonali ta ’ kontraċezzjoni (bħal kondom) biex tevita t- tqala waqt li tkun qed tieħu Agenerase.
If Agenerase makes you dizzy, do not operate any tools or machines.
Agenerase iqabbdek sturdament, m’ għandekx tagħmel użu minn għodda jew tħaddem magni.
84 These capsules also contain sorbitol.
Dawn il- kapsuli fihom ukoll is- sorbitol.
Because Agenerase capsules contain vitamin E, you should not take additional vitamin E supplements.
Minħabba li l- kapsuli ta ’ Agenerase fihom il- vitamina E, m’ għandekx tieħu xi vitamini oħra li fihom il- vitamina E.
Always take Agenerase exactly as your doctor has told you.
Dejjem għandek tieħu Agenerase skond ma jgħidled it- tabib tiegħek.
If you need to take an antacid for indigestion, or if you are taking a drug containing an antacid (e.g. didanosine), you are advised to take it more than an hour before or after Agenerase, otherwise the effects of Agenerase may be reduced.
Jekk ikollok bżonn tieħu mediċini kontra l- aċidu fl- istonku jew xi mediċina li fiha hemm mediċina oħra għal kontra l- acidu fl- istonku (bħal didanosine), inti għandek teħodha ta ’ l- anqas siegħa qabel jew wara li tkun ħadt Agenerase.
If you take more Agenerase than you should If you have taken more than the prescribed dose of Agenerase, you should contact your doctor or pharmacist immediately for advice.
Jekk ħadt aktar Agenerase minn kemm ordnalek it- tabib, għandek tkellem lit- tabib jew spiżjar tiegħek minnufih.
If you forget to take Agenerase If you forget to take a dose of Agenerase, take it as soon as you remember and then continue as before.
Wara tistà tkompli bħal qabel.
Do not take a double dose to make up for forgotten individual doses.
M’ għandekx tieħu doża doppja biex tpatti għal xi doża li tkun insejt tieħu.
Like all medicines, Agenerase can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Agenerase jista ’ jagħmel xi effetti mhux mixtieqa għalkemm mhux kulħadd ikollu.
85 Very common side effects (these can affect more than 10 in 100 patients treated)
Effetti mhux mixtieqa komuni ħafna (dawn jistgħu jaffettwaw aktar minn 10 f’ 100 pazjent trattat) • Uġigħ ta ’ ras, tħossok għajjien • Diarreja, tħossok imqalla, rimettar, gass Raxx fil- Ġilda (ħamra, mtella jew bil- ħakk - Xi drabi r- raxx fil- ġilda jistà jkun qawwi u inti jkollok bżonn twaqqaf din il- mediċina.
If any of the side ffects gets serious, or you notice any effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
Do not use Agenerase after the expiry date which is stated on the carton
M’ għandekx tuża Agenerase3 wara d- data li jiskadi li tidher fuq il- kartuna.
86 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
The active substance is amprenavir Each Agenerase capsule contains 150 mg of amprenavir.
Is- sustanza attiva hi amprenavir Kull kapsula ratba fiha 150 mg ta ’ amprenavir
What Agenerase looks like and the contents of the pack
Id- Dehra ta ’ Agenerase u l- kontenuti tal- pakkett:
Agenerase 150 mg soft capsules are supplied in plastic bottles containing 240 soft capsules.
Agenerase 150 mg kapsuli rotob jiġu fi fliexken li kull wieħed fih 240 kapsula ratba.
These soft capsules are oblong, opaque, off white to cream in colour and marked with the code GX CC2.
Dawn il- kapsuli rotob għandhom forma rettangolari, huma opaki b’ lewn abjad maħmuġ jkanġi għall- krema u stampati bl- ittri GX CC2.
Glaxo Wellcome Operations Priory Street Ware Hertfordshire SG12 ODJ United Kingdom
Glaxo Wellcome Operations Priory Street Ware Hertfordshire SG12 ODJ Renju Unit
For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tad- Detentur ta ’ l- Awtoriżżazzjoni għat- tqegħid fis- Suq.
Česká republika GlaxoSmithKline s.r.o.
90 Česká republika GlaxoSmithKline s. r. o.
Latvija GlaxoSmithKline Latvia SIA Tel: + 371 67312687 lv-epasts@gsk.com
91 Latvija GlaxoSmithKline Latvia SIA Tel: + 371 67312687 lv- epasts@ gsk. com