qanastek/EMEA-V3 huggingface dataset:
In elderly patients with dementia, medicines in the same group as INVEGA have been associated with side effects including sudden weakness or numbness of the face, arms, or legs, instances of slurred speech, or blurred vision.
F’ pazjenti anzjani b’ dimenzja, mediċini fl- istess grupp ta ’ INVEGA ġew assoċjati ma ’ effetti sekondarji li jinkludu telfien f’ daqqa tas- saħħa jew tirżiħ tal- wiċċ, dirgħajn, riġlejn, mumenti ta ’ taħdit ma jinftiehemx jew vista mċajpra.
These symptoms may be associated with stroke.
Dawn is- sintomi jistgħu jkunu assoċjati ma ’ aċċessjoni.
If any of these occur, even for a short period of time, seek medical attention immediately (See section 2, take special care with INVEGA).
Jekk isseħħ waħda minn dawn, anke għal perjodu qasir ta ’ żmien, għandek tfittex attenzjoni medika mal- ewwel (Ara sezzjoni 2, oqgħod attent ħafna b’ INVEGA).
The frequency of possible side effects listed below is defined using the following convention:
Il- frekwenza tal- effetti sekondarji li jista ’ jkun hemm, elenkati hawn taħt, huma definiti skond il - konvenzjoni kif ġej:
very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
komuni ħafna (jaffettwaw aktar minn persuna waħda minn kull 10 li jużawh) komuni (jaffettwaw minn persuna waħda sa 10 persuni minn kull 100 li jużawh) mhux komuni (jaffettwaw minn persuna waħda sa 10 persuni minn kull 1, 000 li jużawh) rari (jaffettwaw minn persuna waħda sa 10 persuni minn kull 10, 000 li jużawh) rari ħafna (jaffettwaw anqas minn persuna waħda minn kull 10, 000 li jużawh) mhux magħrufa (il- frekwenza ma tistax tittieħed stima tagħha mit- tagħrif disponibbli).
Very commonly: headache may be experienced.
Komuni ħafna: tista tesperjenza uġiegħ ta ’ ras.
Common side effects may include:
Effetti sekondarji komuni jistgħu jinkludu:
- sleepiness, feeling dizzy, restlessness, trembling, slowness of movement and muscle stiffness or
- Ħedla, tħossok stordut, nuqqas ta ’ paċenzja, tirtgħod, muviment bil- mod u ebusija tal- muskoli
spasm,
jew spażmi,
- faster heart rate, slowed heart rate, heart beat irregularities,
- taħbit iktar mgħaġġel jew iktar bil- mod tal- qalb, irregolaritajiet fit- taħbit tal- qalb,
- drop in blood pressure upon standing,
- waqgħa tal- pressjoni tad- demm meta tqum,
- stomach ache, dry mouth, increased saliva, being sick (vomiting),
- uġiegħ ta ’ żaqq, ħalq niexef, iktar saliva, tirremetti,
- lack of energy, fatigue,
- nuqqas ta ’ enerġija, għejja,
- increased weight.
- żieda fil- piż,
- increased muscle tension
- żieda fit- tensjoni fil- muskoli..
Uncommon side effects may include:
Effetti sekondarji mhux komuni jistgħu jinkludu:
- increased appetite,
- żieda fl- aptit,
- nightmares,
- ħmar il- lejl,
- feeling dizzy upon standing, uncontrollable movements of face or body, seizures, fainting,
- tħossok stordut meta tqum, muvimenti bla kontroll tal- wiċċ jew tal- ġisem, aċċessjonijiet,
- painful eye movement,
ħassħażin
- sensation your heart is racing, heart rhythm changes,
- muviment ta ’ l- għajnejn li jweġġa ’,
- decreased blood pressure, decreased blood flow,
- tnaqqis tal- pressjoni tad- demm, tnaqqis fiċ- ċirkolazzjoni tad- demm,
- rigid muscles,
- muskoli ibsin,
- accumulation of fluid resulting in swelling of the legs and other dependent body parts.
- akkumulazzjoni ta ’ likwidu li jikkawża infieħ tar- riġlejn jew ta ’ parti oħra tal- ġisem.
While women may experience leakage of fluid or milk from the breast, men may develop breast swelling.
In- nisa jista ’ jkollhom tqattir tal- fluwidu jew ħalib mis- sider, u l- irġiel jista ’ jkollhom sider minfuħ.
Women may experience missed or irregular periods.
In - nisa jista ’ jkollhom pirjid maqbuż jew irregolari.
Men may experience difficulty getting or maintaining an erection.
L- irġiel jistgħu ikollhom diffikulta ’ biex ikollhom jew iżommu erezzjoni, jew sider minfuħ.
Uncommonly, you may develop an abnormality in your electrocardiogram (i. e. tracing of the electrical activity of your heart).
B’ mod mhux komuni, jista ’ jkollok anormalità fl- elettrokardjogramma tiegħek (jiġifieri meta tiċċekkja l- attività elettrika ta ’ qalbek).
125 Since paliperidone is a compound resulting from the breakdown of risperidone (another medicine used to treat schizophrenia) in the human body, any side effects that may occur after the ingestion of risperidone may also occur with INVEGA.
Billi paliperidone huwa kompost li jiġi minn tifrik ta ’ risperidone (mediċina oħra li tittieħed għall- kura ta ’ l- iskiżofrenja) fil- ġisem uman, kull effett sekondarju li jista ’ jseħħ meta tieħu risperidone jista ’ jseħħ ukoll meta tieħu INVEGA.
HOW TO STORE INVEGA
KIF TAĦŻEN INVEGA
Do not use INVEGA after the expiry date which is stated on the blister/ bottle and carton after {MM/ YYYY}.
Tużax INVEGA wara d- data ta ’ skadenza li tidher fuq il- folja/ flixkun u l- kartuna wara {XX/ SSSS}.
Keep the bottle tightly closed in order to protect from moisture.
Żomm il- flixkun magħluq sew biex tipproteġi mill - umditá.
Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali biex tipproteġi mill- umditá.
What INVEGA contains
X’ fih INVEGA
- The active substance is paliperidone
- Is- sustanza attiva hi paliperidone.
Each INVEGA 1.5 mg prolonged-release tablet contains 1.5 mg of paliperidone Each INVEGA 3 mg prolonged-release tablet contains 3 mg of paliperidone.
Kull pillola ta ’ INVEGA tat- 3 mg li terħi l- mediċina bil- mod fiha 3 mg ta ’ paliperidone.
Each INVEGA 6 mg prolonged-release tablet contains 6 mg of paliperidone.
Kull pillola ta ’ INVEGA tas- 6 mg li terħi l- mediċina bil- mod fiha 6 mg ta ’ paliperidone.
Each INVEGA 9 mg prolonged-release tablet contains 9 mg of paliperidone.
Kull pillola ta ’ INVEGA tad- 9 mg li terħi l- mediċina bil- mod fiha 9 mg ta ’ paliperidone.
Each INVEGA 12 mg prolonged-release tablet contains 12 mg of paliperidone.
Kull pillola ta ’ INVEGA tat- 12- il mg li terħi l- mediċina bil- mod fiha 12- il mg ta ’ paliperidone.
The other ingredients are:
Ingredjenti oħra huma:
Polyethylene oxide 200K Sodium chloride Povidone (K29-32) Stearic acid Butyl hydroxytoluene (E321) Ferric Oxide (Yellow) (E172) (3, 12 mg tablet only) Polyethylene Oxide 7000K Ferric Oxide (Red) (E172) Hydroxyethyl Cellulose Polyethylene glycol 3350 Cellulose acetate Iron oxide (Black) (E172) (1.5, 9 mg tablet only)
129 Stearic acid Butyl hydroxytoluene (E321) Ferric Oxide (Isfar) (E172) (pilloli ta ’ 3, 12 mg biss) Polyethylene Oxide 7000K Ferric Oxide (Aħmar) (E172) Hydroxyethyl Cellulose Polyethylene glycol 3350 Cellulose acetate Iron oxide (Iswed) (E172) (pilloli ta ’ 1. 5, 9 mg biss)
Hypromellose Titanium dioxide (E171) Polyethylene glycol 400 (1.5, 6, 9 and 12 mg tablet only) Ferric Oxide (Yellow) (E172) (1.5, 6, 12 mg tablet only) Ferric Oxide (Red) (E172) (1.5, 6, 9 mg tablet only) Lactose monohydrate (3 mg tablet only)
Hypromellose Titanium dioxide (E171) Polyethylene glycol 400 (pilloli ta ’ 1. 5, 6, 9 and 12 mg biss) Ferric Oxide (Isfar) (E172) (pilloli ta ’ 1. 5, 6, 12 mg biss) Ferric Oxide (Aħmar) (E172) (pilloli ta ’ 1. 5, 6, 9 mg biss) Lactose monohydrate (pillola ta ’ 3 mg biss) Triacetin (pillola ta ’ 3 mg biss)
Printing ink:
Linka ta ’ l- ispiżjar:
Iron oxide (Black) (E172) Propylene glycol Hypromellose
Iron oxide (Iswed) (E172) Propylene glycol Hypromellose
What INVEGA looks like and contents of the pack
Id- Dehra ta ’ Invega u l- kontenuti tal- pakkett
INVEGA Prolonged-Release Tablets are capsule shaped.
INVEGA Pilloli li Jerħu l- Mediċina Bil- Mod huma forma ta ’ kapsula.
The 1.5 mg tablets are orange-brown and printed with “ PAL 1.5”, the 3 mg tablets are white and printed with “ PAL 3”, the 6 mg tablets are beige and printed with “ PAL 6”, the 9 mg tablets are pink and printed with “ PAL 9”, and the 12 mg tablets are dark yellow and printed with “ PAL 12”.
Il- pilloli ta ’ 1. 5 mg huma kannella fl- oranġjo u stampati bi “ PAL 1. 5 ”, il- pilloli ta ’ 3 mg huma bojod u stampati bi “ PAL 3 ”, u l - pilloli tal- 6 mg huma bex u huma stampati bi “ PAL 6 ”.
All tablets are available in the following pack sizes:
Il- pilloli ta ’ 9 mg huma roża u stampati bi “ PAL 9 ”, u l- pilloli ta ’ 12- il mg huma sofor skuri u stampati bi “ PAL 12 ”.
Each
- Fliexken: fliexken tal- polyethylene b’ densità għolja bi 30 pillola u 350 pillola u b’ magħlaq
bottle contains two silica gel pouches which are provided to absorb moisture and keep the tablets dry.
reżistenti għat- tfal. Kull flixkun fih żewġ pakketti ta ’ silica gel li jiġu pprovduti biex jassorbu l - umdu biex il- pilloli jibqgħu nexfin.
- Blisters:
- Folji:
14, 28, 30, 49, 56, and 98 tablets in polyvinyl chloride laminated with
14, 28, 30, 49, 56, u 98 pillola f ’ polyvinyl chloride illaminat b’ saff li tinbotta b’ subgħajk
polychlorotrifluoroethylene/ aluminium push-through layer (white or clear) or 14, 28, 49, 56, and 98 tablets in oriented polyamidealuminium- polyvinyl chloride/ aluminium push-through layer
ta ’ polychloro- trifluoroethylene/ aluminju (bojod jew trasparenti) jew 14, 28, 30, 49, 56, u 98 pillola b’ saff orjentat li tinbotta b’ subgħajk ta ’ polyamidealuminium - polyvinyl chloride/ aluminju.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu ghal skop kummerċjali.
Marketing Authorisation Holder and Manufacturer Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Janssen- Cilag International NV, Turnhoutseweg 30, B- 2340 Beerse, Il- Belġju
Manufacturer Janssen-Cilag SpA Via C.
Manifattur Janssen- Cilag SpA Via C.
Janssen 04010 Borgo San Michele, Latina Italy
Janssen 04010 Borgo San Michele, Latina L- Italja
127 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation.
130 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Eesti JANSSEN-CILAG Polska Sp. z o. o.
Eesti JANSSEN- CILAG Polska Sp z o. o.
France JANSSEN-CILAG Tel:
România France JOHNSON AND JOHNSON d. o. o JANSSEN- CILAG Tel: +40 21 207 1800 Tel:
Ireland JANSSEN-CILAG Ltd.
131 Ireland JANSSEN- CILAG Ltd.
Detailed information on this product is available on the website of the European Medicines Evaluation Agency (EMEA): http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. eu /.
129
132
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwetta sabiex jasal għar- rakkomandazzjonijiet tiegħu dwar kif tintuża l- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ aktar informazzjoni dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l - Fuljett ta ’ Tagħrif (li jagħmel ukoll parti mill- EPAR) jew ikkuntattja t- tabib jew l- ispiżjar tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni relatata mar- rakkomandazzjonijiet tas- CHMP, tista ’ taqra d - Diskussjoni Xjentifika (li tagħmel ukoll parti mill- EPAR).
What is Invirase?
X’ inhu Invirase?
Invirase is a medicine containing the active substance saquinavir.
Invirase huwa mediċina li fiha s- sustanza attiva saquinavir.
It is available as brown and green capsules (200 mg) and orange, oval tablets (500 mg).
Huwa disponibbli f’ kapsuli kannella u ħodor (200 mg) u oranġjo, pilloli ovali (500 mg).
What is Invirase used for?
Għal xiex jintuża Invirase?
Invirase is an antiviral medicine.
Invirase huwa mediċina antivirali.
It is used to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Jintuża għat- trattament ta ’ adulti infettati bil- vajrus tal - immunodefiċjenza umana ta ’ tip I (HIV- 1), vajrus li jikkaġuna s- sindromu minn immunodefiċjenza akkwiżita (AIDS).
Invirase is always used in combination with ritonavir (another antiviral medicine) and other antiviral medicines.
Invirase jintuża dejjem flimkien ma ’ ritonavir (mediċina antivirali oħra) u ma ’ mediċini oħra antivirali.
How is Invirase used?
Kif jintuża Invirase?
Treatment with Invirase should be started by a doctor who has experience in the treatment of HIV infection.
It- terapija b’ Invirase għandha tinbeda minn tabib li għandu esperjenza fit- trattament ta ’ infezzjonijiet tal- HIV.
The recommended dose of Invirase for adults and adolescents over 16 years of age is 1,000 mg twice a day with 100 mg ritonavir, with or after food.
Id- doża rakkomandata ta ’ Invirase għall- adulti u adolexxenti ta ’ ’ l fuq minn 16 - il sena hija ta ’ 1, 000mg darbtejn kuljum ma ’ 100mg ritonavir, ma ’ jew wara l- ikel.
Invirase should be used with caution in patients who have severe problems with their kidneys or moderate problems with their liver.
Invirase għandu jintuża b’ kawtela f’ pazjenti li għandhom problemi gravi tal- kliewi jew problemi moderati tal- fwied.
It should not be used in patients who have severe liver problems.
M’ għandux jintuża f’ pazjenti bi problemi gravi tal- fwied.
How does Invirase work?
Kif jaħdem Invirase?
The active substance in Invirase, saquinavir, is a protease inhibitor.
Is- sustanza attiva ta ’ Invirase, saquinavir, hija inibitur tal- proteażi.
It blocks an enzyme called protease, which is involved in the reproduction of HIV.
Hija timblokka enzima imsejħa proteażi li hija involuta fir- riproduzzjoni tal- HIV.
When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Meta l- enzima tiġi imblokkata, il- vajrus ma jirriproduċix ruħu b’ mod normali, b’ hekk jittardja l- firxa tal- infezzjoni.
Ritonavir is another protease inhibitor that is used as a ‘ booster’.
Ritonavir hija inibitur tal - proteażi ieħor użat bħala ‘ booster ’.
It slows down the rate at which saquinavir is broken down, increasing the levels of saquinavir in the blood.
Huwa jnaqqas ir- rata li bih jiġi assorbit saquinavir u b’ hekk jiżdied il- livell ta ’ saquinavir fid- demm.
This allows a lower dose of saquinavir to be used for the same antiviral effect.
Dan jippermetti doża anqas ta ’ saquinavir li għandha tintuża għall - istess effett antivirali.
Invirase, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Invirase, meta tittieħed flimkien ma ’ mediċini antivirali oħra, inaqqas l- ammont ta ’ HIV fid- demm u jżommu f’ livell baxx.
Invirase does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Invirase ma jfejjaqx l- infezzjoni mill- HIV jew tal- AIDS, iżda jista ’ jittardja l- ħsara għas- sistema immunoloġika u l- iżvilupp ta ’ infezzjonijiet assoċjati mal - AIDS.
How has Invirase been studied?
Kif ġie studjat Invirase?
Invirase was assessed in six main studies involving 1,576 patients.
L- effikaċja tal- Invirase ġiet valutata f’ sitt studji prinċipali li involvew 1, 576 pazjenti.
The first four studies assessed the medicine’ s effects without ritonavir.
L- ewwel erba ’ studji vvalutaw l- effetti tal- mediċina mingħajr ritonavir.
The combination of Invirase with ritonavir was assessed in 656 patients in two studies that compared Invirase with indinavir and with lopinavir (other antiviral 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Il- kombinazzjoni ta ’ Invirase u ritonavir ġiet evalwata f’ 656 pazjent f’ żewġ studji li qabblu Invirase ma ’ indinavir u ma ’ lopinavir (mediċini 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu European Medicines Agency, 2008 Reproduction is authorised provided the source is acknowledged antivirali oħrajn), it- tnejn in kombinazzjoni ma ’ ritonavir u mediċini antirali oħrajn.
These studies measured the number of patients in whom treatment had stopped working after 48 weeks, as determined by a rise in the level of HIV in the blood (viral load).
Dawn l- istudji studjaw u kejlu numru ta ’ pazjenti li fihom it- trattament waqaf jaħdem wara 48 ġimgħa, kif stabbilit miż- żieda fil- livell tal- HIV fid- demm (viral load - tagħbija virali).
What benefit has Invirase shown during the studies?
X’ benefiċċji wera Invirase waqt l- istudji li ġew mwettqa?
Invirase, taken in combination with other antiviral medicines, resulted in falls in viral loads and improvements in the immune system.
Invirase meħud flimkien ma ’ mediċini antivirali oħrajn wassal għat- tnaqqis tat- tagħbijiet virali u għat - titjib fis- sistema immunitorja.
In the studies of Invirase in combination with ritonavir, Invirase led to similar rates of treatment failure to indinavir, but higher rates than lopinavir.
Fl- istudji fuq Invirase meħud flimkien mar- ritonavir, Invirase wassal għal rati simili għal dawk ta ’ indinavir fin- nuqqas ta ’ suċċess tat- trattament, iżda rati għola mill - lopinavir.
This was mainly caused by more patients stopping Invirase treatment rather than by any differences in the effectiveness of the medicines.
Dan kien ikkawwżat prinċipalment minn aktar pazjenti li waqqfu t- trattament b’ Invirase iktar milli minn xi differenzi fl- effikaċja tal- mediċini.
What is the risk associated with Invirase?
X’ inhu r- riskju assoċjat ma ’ Invirase?
The most common side effects when taking Invirase in combination with ritonavir (seen in more than 1 patient in 10) are diarrhoea, nausea (feeling sick), increased levels of liver enzymes, cholesterol and triglycerides (a type of fat) in the blood, and decreased levels of platelets in the blood (components that help blood to clot).
L- effetti sekondarji l- aktar komuni fit- teħid ta ’ Invirase flimkien ma ’ ritonavir (kif jidher f’ pazjent 1 minn kull 10) huma dijarrea, nawżea (dardir) żieda fil- livelli tal- enżimi tal- fwied, kolesterol u trigliċeridi (tip ta ’ xaħam) fid- demm u livelli aktar baxxi ta ’ platelets fid- demm (komponenti li jgħinu fit- tagħqid tad- demm).
For the full list of all side effects reported with Invirase, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtati f’ Invirase, ara l- Fuljett ta ’ Tagħrif tal- Pakkett.
Invirase should not be used in people who may be hypersensitive (allergic) to saquinavir or any of the other ingredients.
Invirase ma għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal saquinavir jew għal xi sustanzi oħra tiegħu.
It must not be used in patients who have severe problems with their liver or who are taking any of the following medicines: • terfenadine, astemizole (commonly used to treat allergy symptoms - these medicines may be available without prescription); • pimozide (used to treat mental illness); • cisapride (used to relieve certain stomach problems); • amiodarone, propafenone, flecainide (used to correct irregular heartbeat); • triazolam, oral (taken by mouth) midazolam (used to relieve anxiety or difficulty sleeping); • simvastatin, lovastatin (used to lower cholesterol); • ergot alkaloids, such as ergotamine, dihydroergotamine, ergonovine and methylergonovine (used to treat migraine headache); • rifampicin (used to treat tuberculosis); • medicines that may interact with Invirase and cause harmful side effects.
M’ għandux jintuża f’ pazjentili jbatu minn mard tal- fwied gravi jew li qed jieħdu xi waħda mill- mediċini li ġejjin: • terfenadine, astemizole (użati l- aktar biex jiġu ttrattati sintomi ta ’ allerġija - dawn il- mediċini jistgħu jinkisbu mingħajr riċetta), • pimozide (użat għat- trattament ta ’ mard mentali), • cisapride (użat biex jagħti soljiev għal ċerti problemi tal- istonku), • amiodarone, propafenon, flecainide (użati biex jiġi korrett taħbit tal- qalb irregolari), • triazolam, orali (meħuda oralment) midazolam (użati biex tittaffa l- ansjetà jew id- diffikultà biex torqod), • simvastatin, lovastatin (użati għat- tnaqqis tal- kolesterol), • alkalojdi tal- qamħ (ergot), bħalma huma ergotamina, diidroergotamina, ergonovina u metilergonovina (użati biex jittrattaw l- emikranja), • rifampicin (użat għall- kura tat- tuberkulożi). • mediċini li jistgħu jagħmlu reazzjoni negattiva ma ’ Invirase u jikkawżaw effetti sekondarji mhux mixtieqa u ta ’ dannu.
Caution is needed when Invirase is taken at the same time as other medicines.
Meta Invirase jingħata fl- istess ħin ta ’ mediċini oħra hija meħtieġa kawtela.
See the Package Leaflet for full details.
Ara l- Fuljett ta ’ Tagħrif tal- Pakkett għal dettalji sħaħ.
As with other anti-HIV medicines, patients taking Invirase may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Bħal fil- każ ta ’ mediċini ta ’ kontra l- HIV oħra, pazjenti li jieħdu Invirase jistgħu jkunu f’ riskju ta ’ lipodistrofija (bidliet fit- tqassim tax- xaħam tal- ġisem), osteonekrożi (mewt tat- tessut tal- għadam) jew sindromu ta ’ riattivazzjoni immunitarja (sintomi ta ’ infezzjoni kkaġunati mis- sistema immuni li qed tirkupra).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Invirase.
Pazjenti li għandhom problemi bil- fwied tagħhom (li jinkludu infezzjoni ta ’ epatite B jew Ċ) jistgħu jkunu esposti għal riskju akbar ta ’ ħsara fil- fwied meta jieħdu Invirase.
Why has Invirase been approved?
Għaliex ġie approvat Invirase?
The Committee for Medicinal Products for Human Use (CHMP) decided that Invirase’ s benefits are greater than its risks for the treatment of HIV-1 infected adult patients in combination with other antiretroviral medicinal products.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Invirase huma ogħla mir- riskji tiegħu għat- trattament ta 'adulti infettati mill- HIV- 1 flimkien ma ’ prodotti mediċinali antivirali oħrajn.
The Committee recommended that Invirase be given marketing authorisation.
Il- Kumitat irrakkomanda li l- Invirase jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Invirase was originally authorised under ‘ Exceptional Circumstances’, because, for scientific reasons, limited information was available at the time of approval.
Oriġinarjament Invirase kien awtorizzat f ’ "Ċirkostanzi Eċċezzjonali", minħabba li, għal raġunijiet xjentifiċi, kienet disponibbli informazzjoni limitata fiż- żmien tal- approvazzjoni.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 8 April 1999.
Billi l- kumpanija kienet ipprovdiet it- tagħrif addizzjonali mitlub, iċ - "Ċirkustanzi Eċċezzjonali" spiċċaw fit- 8 ta ’ April 1999.
Other information about Invirase:
Informazzjoni oħra dwar Invirase:
The European Commission granted a marketing authorisation valid throughout the European Union for Invirase to Roche Registration Limited on 4 October 1996.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Invirase lil Roche Registration Limited fl- 4 ta ’ Ottubru 1996.
The marketing authorisation was renewed on 4 October 2001 and on 4 October 2006.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet aġġornata fl- 4 ta ’ Ottubru 2001 u fl- 4 ta ’ Ottubru 2006.
The full EPAR for Invirase can be found here.
11- 2008.
1 1.
2 1.
INVIRASE 200 mg hard capsules.
INVIRASE 200 mg kapsuli iebsin.
One capsule contains 200 mg of saquinavir as saquinavir mesilate.
Kapsula waħda fiha 200 mg saquinavir bħala saquinavir mesylate.
Contains lactose anhydrous:
Fih lactose anhydrous:
63.3 mg.
63. 3 mg.
For a full list of excipients, see section 6.1.
Għal- lista kompleta ta’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Light brown and green, opaque hard capsule with the marking “ ROCHE” and the code “ 0245” on each half of the capsule shell.
Kapsula iebsa, opaka, kannella ċara u aħdar bil- marka ” ROCHE ” u l- kodiċi ” 0245 ” fuq kull nofs tal - qoxra tal- kapsula.
Invirase is indicated for the treatment of HIV-1 infected adult patients.
4. 1 Indikazzjonijiet terapewtiċi
Invirase should only be given in combination with ritonavir and other antiretroviral medicinal products (see section 4.2).
Invirase huwa indikat għat- trattament ta ’ adulti infettati bl- HIV- 1.
Therapy with Invirase should be initiated by a physician experienced in the management of HIV infection.
It- terapija b’ Invirase għandha tinbeda minn tabib b’ esperjenza fl- immaniġġar ta ’ l- infezzjoni ta ’ l - HIV.
Adults and adolescents over the age of 16 years:
Adulti u adolexxenti li għandhom aktar minn 16- il sena:
In combination with ritonavir The recommended dose of Invirase is 1000 mg (5 x 200 mg capsules) two times daily with ritonavir 100 mg two times daily in combination with other antiretroviral agents.
Flimkien ma ’ ritonavir Id- doża rakkomandata ta ’ Invirase hija ta ’ 1000 mg (5 kapsuli ta ’ 200 mg) mogħtija darbtejn kuljum flimkien ma ’ 100 mg ta ’ ritonavir mogħtija darbtejn kuljum, flimkien ma ’ sustanzi antitretrovirali oħrajn.
Invirase capsules should be swallowed whole and taken at the same time as ritonavir with or after food (see section 5.2).
Il- kapsuli ta ’ Invirase għandhom jinbelgħu sħaħ u jittieħdu fl- istess ħin ma ’ ritonavir ma ’ l- ikel jew wara l- ikel( ara sezzjoni 5. 2).
Renal and hepatic impairment:
Indeboliment tal- kliewi u tal- fwied:
No dosage adjustment is necessary for patients with mild to moderate renal or mild hepatic impairment.
M’ hemmx bżonn ta ’ aġġustament fid- dożaġġ f’ pazjenti b’ indeboliment ħafif samoderat tal- kliewi jew indeboliment ħafif tal- fwied.
Caution should be exercised in patients with severe renal or moderate hepatic impairment.
Irid ikun hemm attenzjoni f’ pazjenti b’ indeboliment sever tal- kliewi jew indeboliment moderat tal- fwied.
Invirase/ ritonavir is contraindicated in patients with decompensated hepatic impairment (see sections 4.3 and 4.4).
Invirase/ ritanovir huwa kontra- indikat f’ pazjenti b’ indeboliment dekompensat tal- fwied (ara sezzjonijiet 4. 3 u 4. 4).
Children under the age of 16 and adults over 60 years:
Tfal taħt l- eta ’ ta ’ 16- il sena u adulti aktar minn 60 sena:
The experience with Invirase in children below the age of 16 and adults over 60 years is limited.
L- esperjenza b ’ Invirase fit- tfal taħt l- eta ’ ta ’ 16 u adulti akbar minn 60 sena hija limitata.
In children, as in adults, Invirase should only be given in combination with ritonavir.
Fit- tfal, bħal fl- adulti, Invirase għandu jingħata biss flimkien ma ’ ritanovir.
Invirase/ ritonavir is contraindicated in decompensated liver disease (see section 4.4).
Invirase/ ritanovir huwa kontra- indikat fil- marda tal- fwied dekompensat (ara sezzjoni 4. 4).
2 Invirase/ ritonavir should not be given together with other medicinal products which may interact and result in potentially life threatening undesirable effects.
3 Invirase/ ritanovir m’ għandux jingħata flimkien ma ’ prodotti mediċinali oħra li jistgħu jinterferixxu u jwasslu għall- effetti mhux mixtieqa potenżjalment fatali.
Medicinal products which should not be given with Invirase/ ritonavir include: • terfenadine, astemizole, pimozide, cisapride, amiodarone, propafenone and flecainide (potential for life threatening cardiac arrhythmia) • midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), triazolam (potential for prolonged or increased sedation, respiratory depression) • simvastatin, lovastatin (increased risk of myopathy including rhabdomyolysis) • ergot alkaloids (e. g. ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (potential for acute ergot toxicity) • rifampicin (risk of severe hepatocellular toxicity) (see sections 4.4, 4.5, and 4.8).
Prodotti mediċinali li m’ għandhomx jingħataw ma ’ Invirase/ ritonavir jinkludu: terfenadine, astemizole, pimozide, cisapride, amiodarone, propafenone u flecainide (potenzjal għal arritmija kardijaka li tista ’ twassal għall- mewt) midazolam mogħti mill- ħalq (għall- kawtela dwar midazolam mogħti b’ mod parenterali, ara sezzjoni 4. 5), triazolam (potenzjal għal sedazzjoni mtawla jew aktar qawwija, dipressjoni respiratorja) simvastatin, lovastatin (żjieda fir- riskju ta ’ mijopatija inkluż rhabdomyolysis) ergot alkaloids (e. ż. ergotamine, dihydroergotamine, ergonovine, u methylergonovine) (potenzjal għal tossiċità akuta ta ’ ergot) rifampicin (riskju ta ’ tossiċità epatoċellolari severa) (ara sezzjonijiet 4. 4, 4. 5, u 4. 8).
Considerations when initiating Invirase therapy:
Konsiderazzjonijiet meta tibda t- terapija b’ Invirase:
Invirase should not be given as the sole protease inhibitor.
Invirase m’ għandux jingħata bħala l- uniku inibitur tal- protease.
Invirase should only be given in combination with ritonavir (see section 4.2).
Invirase għandu jingħata biss flimkien ma ’ ritonavir (ara sezzjoni 4. 2).
Patients should be informed that saquinavir is not a cure for HIV infection and that they may continue to acquire illnesses associated with advanced HIV infection, including opportunistic infections.
Il- pazjenti għandhom ikunu nfurmati li saquinavir mhuwiex xi kura għall- infezzjoni ta ’ l- HIV u li huma jistgħu jkomplu jieħdu l- mard assoċjat ma ’ infezzjoni avvanzata ta ’ l- HIV, li jinkludu infezzjonijiet opportunistiċi.
Patients should also be advised that they might experience undesirable effects associated with co- administered medications.
Il- pazjenti għandhom ikunu avżati wkoll li jista ’ jkollhom esperjenza ta ’ effetti mhux mixtieqa assoċjati mal- mediċini mogħtija miegħu.
The safety and efficacy of saquinavir/ ritonavir has not been established in patients with significant underlying liver disorders, therefore saquinavir/ ritonavir should be used cautiously in this patient population.
Is- sigurtà u l- effikaċja ta ’ saquinavir/ ritanovir ma kinetx stabbilita f’ pazjenti b’ mard prinċipali sinifikattiv tal- fwied, għalhekk saquinavir/ ritanovir għandu jintuża b’ attenzjoni f’ din il - popolazzjoni ta ’ pazjenti.
Invirase/ ritonavir is contraindicated in patients with decompensated liver disease (see section 4.3).
Invirase/ ritanovir huwa kontra- indikat f’ pazjenti b’ marda tal - fwied dikompensat (ara sezzjoni 4. 3).
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse events.
Pazjenti b’ epatite kronika B jew C u trattati b’ terapija mħallta antiretrovirali huma f’ riskju akbar għall- effetti avversi serji u potenzjalment fatali tal- fwied.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
F’ każ tat - terapija antivirali mħallta għall- epatite B jew C, jekk jogħġbok irreferi wkoll għall- informazzjoni rilevanti tal- prodott għal dawn il- prodotti mediċinali.
Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Pazjenti b’ disfunzjoni tal- fwied li kienet teżisti minn qabel li tinkludi epatite attiva kronika għandhom frekwenza akbar ta ’ abnormalitajiet fil- funzjoni tal- fwied waqt it- terapija mħallta antiretrovirali u għandhom ikunu osservati skond il- prattika stàndard.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Jekk hemm evidenza ta ’ mard tal- fwied li qed imur għall- agħar f’ dawn il- pazjenti, l- interruzjoni jew it- twaqqif tat- trattament irid ikun kunsidrat.
In cases of mild hepatic impairment no initial dosage adjustment is necessary at the recommended dose.
F’ każ ta ’ indeboliment ħafif tal- fwied l- ebda aġġustament fid- dożaġġ tal- bidu ma huwa meħtieġ fid - doża rakkomandata.
The use of Invirase in combination with ritonavir in patients with moderate hepatic impairment has not been studied.
L- użu ta ’ Invirase flimkien ma ’ ritonavir f’ pazjenti b’ indeboliment tal- fwied moderat ma kinetx studjata.
In the absence of such studies, caution should be exercised, as increases in saquinavir levels and/ or increases in liver enzymes may occur.
Fin- nuqqas ta ’ studji bħal dawn, attenzjoni għandha tingħata, għax żidiet fil- livelli ta ’ saquinavir u/ jew żidiet fl- enżimi tal- fwied jistgħu jseħħu.
There have been reports of exacerbation of chronic liver dysfunction, including portal hypertension, in patients with underlying hepatitis B or C, cirrhosis and other underlying liver abnormalities.
Kien hemm rapporti ta ’ aggravar ta ’ abnormalità kronika tal- fwied, li tinkludi pressjoni għoljaportali, f’ pazjenti b’ epatite B jew C prinċipali, ċirrożi u abnormalitajiet prinċipali oħrajn tal- fwied.
Renal clearance is only a minor elimination pathway, the principal route of metabolism and excretion for saquinavir being via the liver.
Il- clearance mill- kliewi hija biss mezz minuri ta ’ l- eliminazzjoni, ir- rotta prinċipali tal- metaboliżmu u ta ’ tneħħija mill- ġisem għal saquinavir hija mill- fwied.
Therefore, no initial dose adjustment is necessary for patients with renal impairment.
Għalhekk, l- ebda aġġustament fid- doża tal- bidu m’ huwa meħtieġ għall- pazjenti b’ indeboliment tal- kliewi.
However, patients with severe renal impairment have not been studied and caution should be exercised when prescribing saquinavir/ ritonavir in this population.
Madankollu, pazjenti b’ indeboliment serju tal- kliewi għadhom ma kienux studjati u attenzjoni għandha tingħata meta saquinavir/ ritanovir ikun preskritt f’ dan il- grupp ta ’ nies.
Patients with chronic diarrhoea or malabsorption:
Pazjenti b’ dijareja kronika jew b’ disturbi fl- assorbiment:
No information on boosted saquinavir and only limited information on the safety and efficacy of unboosted saquinavir is available for patients suffering from chronic diarrhoea or malabsorption.
M’ hemmx informazzjoni dwar saquinavir msaħħah u hemm biss tagħrif limitat dwar is- sikurtà u l- effikaċja ta ’ saquinavir mhux msaħħah għal pazjenti li jsofru minn dijareja kronika jew distrurbi fl- assorbiment.
It is unknown whether patients with such conditions could receive subtherapeutic saquinavir levels.
Mhux magħruf jekk pazjenti b’ kondizzjonijiet bħal dawn jistgħux jirċievu livelli ta ’ saquinavir taħt il- livell terapewtiku.
Children under the age of 16 and adults over 60 years:
Tfal taħt l- eta ’ ta ’ 16- il sena u adulti akbar minn 60 sena:
The experience with Invirase in children below the age of 16 and adults over 60 years is limited.
L- esperjenza b’ Invirase fit- tfal taħt l- eta ’ ta ’ 16 u adulti akbar minn 60 sena hija limitata.
3 Lactose intolerance:
4 Intolleranza għall- lattosju:
Invirase 200 mg capsules contain lactose.
Kapsuli ta ’ Invirase 200 mg fihom lattosju.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti bi problema rari ereditarji ta ’ intolleranza għall- galattosju, defiċjenza ta ’ Lapp lactase jew assorbiment ħażin ta ’ glukożju- galattosju n’ għandhomx jieħdu din il- mediċina.
Patients with haemophilia:
Il- pazjenti b’ emofilja:
There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in haemophiliac patients type A and B treated with protease inhibitors.
Kien hemm rapporti ta ’ żjieda fil- fsada (ħruġ ta ’ demm), inkluż ematomi u emartrożi spontanji tal- ġilda, f’ pazjenti b’ emofilja tat- tip A u B ikkurati bl- inibituri tal- protease.
In some patients additional factor VIII was given.
F’ xi pazjenti, ingħata wkoll il- fattur VIII.
In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
F’ aktar minn nofs il- każijiet irrappurtati, l- kura bl- inibituri tal - protease tkompliet, jew inbdiet mill- ġdid jekk il- kura kienet twaqfet.
A causal relationship has been evoked, although the mechanism of action has not been elucidated.
Relazzjoni kawżali kienet ipotizzata, għalkemm il- mekkaniżmu ta ’ l- azzjoni ma kienx spjegat.
Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.
Pazjenti emofiliċi għandhom għalhekk ikunu mgħarrfa bil- possibbiltà ta ’ żjieda fil- fsada.
Diabetes mellitus and hyperglycaemia:
Dijabete mellitus u ipergliċemja:
New onset diabetes mellitus, hyperglycaemia or exacerbation of existing diabetes mellitus has been reported in patients receiving protease inhibitors.
Żvilupp għall- ewwel darba tal- marda tad- dijabete mellitus, ipergliċemja jew aggravar ta ’ dijabete mellitus eżistenti kienu irrappurtati f’ pazjenti li qed jirċievu inibituri tal- protease.
In some of these patients, the hyperglycaemia was severe and in some cases was also associated with ketoacidosis.
F’ xi ftit minn dawn il- pazjenti, l- ipergliċemja kienet serja u f’ xi ftit każijiet kienet wkoll assoċjata ma ’ ketoaċidożi.
Many patients had confounding medical conditions, some of which required therapy with agents that have been associated with the development of diabetes mellitus or hyperglycaemia.
Ħafna pazjenti kellhom kundizzjonijiet mediċi li jikkonfondu, li ftit minnhom kienu jeħtieġu terapija b’ sustanzi li kienu assoċjati ma ’ l- iżvilupp tad- dijabete mellitus jew ta ’ l- ipergliċemja.
Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV infected patients.
It- terapija antiretrovirali kombinata kienet assoċjata mar- ridistribuzzjoni tax- xaħam tal - ġisem (lipodistrofija) f’ pazjenti infettati bl- HIV.
The long-term consequences of these events are currently unknown.
Il- konsegwenzi fit- tul ta ’ dawn l- effetti għal issa mhumiex magħrufin.
Knowledge about the mechanism is incomplete.
Tagħrif dwar il- mekkaniżmu huwa inkomplet.
A connection between visceral lipomatosis and PIs and lipoatrophy and Nucleoside Reverse Transcriptase Inhibitors (NRTIs) has been hypothesised.
Konnessjoni bejn il- lipomatożi tal- vixxri u l- inibituri tal- protease (PIs) u l- lipoatrofija u l- inibituri Nucleoside Reverse Transcriptase (NRTIs) kienet ipotizzata.
A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
Riskju ogħla ta ’ lipodistrofija kien assoċjat ma ’ fatturi individwali bħal età avvanzata u fatturi konnessi ma ’ mediċina bħal dewmien aktar fit- tul tal- kura antiretrovirali u disturbi metaboliċi assoċjati.
Clinical examination should include evaluation for physical signs of fat redistribution.
L- eżami kliniku għandu jinkludi valutazzjoni għal sinjali fiżiċi tar - ridistribuzzjoni tax- xaħam.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Konsiderazzjoni għandha tingħata għall- qies tal- lipidi fis- serum u tal - glukożju fid- demm ta ’ meta wieħed ikun sajjem.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Mard tal- lipidi għandhom ikunu kkurati kif inhu klinikament xieraq (ara sezzjoni 4. 8.).
Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV– disease and/ or long-term exposure to combination antiretroviral therapy (CART).
Għalkemm l- etjoloġija hija kkunsidrata bħala multifattorjali (inkluż użu ta ’ kortikosterojdi, konsum ta ’ alkoħol, immunosoppressjoni severa, indiċi tal- massa tal- ġisem għola), kienu rrappurtati każijiet ta ’ osteonekrożi speċjalment f’ pazjenti b’ marda ta ’ l- HIV avvanzata u/ jew espożizzjoni fit- tul għal terapija antiretrovirali kombinata (CART).
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Il- pazjenti għandhom jiġu avżati sabiex ifittxu parir mediku jekk iħossu weġgħat u uġigħ fil- ġogi, egħbusija fil- ġogi jew diffikultà fil - moviment.
In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Sindromu tar- Rijattivazzjoni Mmuni: f’ pazjenti nfettati b’ HIV b’ defiċjenza qawwija fl- immunità fiż - żmien li nbdiet it- terapija antiretrovirali kombinata (CART), reazzjoni nfjammatorja għall- patoġeni opportunistiċi astintomatiċi jew residwi tista ’ sseħħ u tikkawża kondizzjonijiet kliniċi serji, jew taggrava s- sintomi.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Tipikament, reazzjonijiet bħal dawn ġew osservati sa fl- ewwel ftit ġimgħat jew xhur mill- bidu ta ’ CART.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
Eżempji rilevanti huma retinite minn cytomegalovirus, infezzjonijiet ġeneralizzati u/ jew lokalizzati minn mikobakterja, u pnewmonja ikkawżata minn Pneumocystis carinii.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Kull sintomu inflammatorju għandu jiġi evalwat u kura mibdija skond il- bżonn.
Interaction with ritonavir:
Interazzjoni ma ’ ritonavir:
The recommended dose of Invirase and ritonavir is 1000 mg Invirase plus 100 mg ritonavir twice daily.
Id- doża rakkomandata ta ’ Invirase u ta ’ ritonavir hija ta ’ 1000 mg ta ’ Invirase flimkien ma ’ 100 mg ta ’ ritonavir darbtejn kuljum.
Higher doses of ritonavir have been shown to be associated with an increased incidence of adverse events.
Intwera li dożi ogħla ta ’ ritonavir kienu assoċjati ma ’ inċidenza għola ta ’ effetti avversi.
Co-administration of saquinavir and ritonavir has led to severe adverse events, mainly diabetic ketoacidosis and liver disorders, especially in patients with pre- existing liver disease.
L- użu flimkien ta ’ saquinavir u ta ’ ritonavir wassal għall- effetti avversi serji, l- aktar il- ketoaċidożi dijabetika u mard tal- fwied, speċjalment f’ pazjenti b’ mard tal- fwied li kien jeżisti minn qabel.
Interaction with tipranavir:
Interazzjoni ma ’ tipranavir:
Concomitant use of boosted saquinavir and tipranavir, co-administered with low dose ritonavir in a dual-boosted regimen, results in a significant decrease in saquinavir plasma concentrations (see section 4.5).
L- użu flimkient ta ’ saquinavir msaħħaħ u tipranavir, fimkien ma ’ doża baxxa ta ’ ritonavir f’ dożaġġ msaħħaħ doppju, wassal għal tnaqqis sinnifikanti fil- konċentrazzjonijiet ta ’ saquinavir fil- plażma (ara sezzjoni 4. 5).
Therefore, the co-administration of boosted saquinavir and tipranavir, co-administered with low dose ritonavir, is not recommended.
Għalhekk, l- għotja flimkien ta ’ saquinavir u tipranavir msaħħa, fimkien ma ’ doża baxxa ta ’ ritanovir, mhux rakkomandat.
Interaction with HMG-CoA reductase inhibitors:
Interazzjoni ma ’ inibituri ta ’ l- HMG- CoA reductase:
Caution must be exercised if Invirase/ ritonavir is used concurrently with atorvastatin, which is metabolised to a lesser extent by CYP3A4.
Attenzjoni trid tittieħed jekk Invirase/ ritonavir jkun użat flimkien ma ’ atorvastatin, li huwa metabolizzat fi grad inqas mis- CYP3A4.
In this situation a reduced dose of atorvastatin should be considered.
F’ din is - sitwazzjoni, doża mnaqqsa ta ’ atorvastatin għandha tiġi kkunsidrata.
If treatment with a HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended (see section 4.5).
Jekk kura b’ inibitur ta ’ l- HMG - CoA reductase hija ndikata, pravastatin jew fluvastatin huma rakkomandati (ara sezzjoni 4. 5).
4 Oral contraceptives:
5 Kontraċettivi mill- ħalq:
Because concentration of ethinyl estradiol may be decreased when co- administered with Invirase/ ritonavir, alternative or additional contraceptive measures should be used when oestrogen-based oral contraceptives are co-administered (see section 4.5).
Minħabba li l- konċentrazzjoni ta ’ ethinyl estradiol tista ’ tonqos meta jingħata fimkien ma ’ Invirase/ ritonavir, miżuri alternattivi jew addizzjonali ta ’ kontraċezzjoni iridu jintużaw meta kontraċettivi b’ bażi ta ’ estroġenu jingħataw fl- istess ħin (ara sezzjoni 4. 5).
Glucocorticoids:
Glukokortikojdi:
Concomitant use of boosted saquinavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
L- użu ta ’ saquinavir msaħħaħ flimkien ma ’ fluticasone jew glukokortikojdi oħra li huma metabolizzati minn CYP3A4 mhux rakkomandat sakemm il- benefiċċju potenzjali tal- kura ma jkunx akbar mir- riskju ta ’ effetti kortikosterojdi sistemiċi, inkluż is- sindromu ta ’ Cushing u soppressjoni ta ’ l- adrenali (are sezzjoni 4. 5).
Interaction with efavirenz:
Interazzjoni ma ’ Efavirenz:
The combination of saquinavir and ritonavir with efavirenz has been shown to be associated with an increased risk of liver toxicity; liver function should be monitored when saquinavir and ritonavir are co-administered with efavirenz.
Il- kombinazzjoni ta ’ saquinavir u ritonavir ma ’ efavirenz intweriet li hija assoċjata ma ’ riskju għola ta ’ tossiċità fil- fwied; funżjoni tal- fwied għandha tiġi sorveljata meta saquinavir u ritonavir jingħataw flimkien ma ’ efavirenz.
No clinically significant alterations of either saquinavir or efavirenz concentration were noted in studies in healthy volunteers or in HIV- infected patients (see section 4.5).
L- ebda tibdiliet klinkament sinnifikanti fil - konċentrazzjonijiet ta ’ saquinavir jew efavirenz ma ġew osservati fi studji f’ volontiera f’ saħħithom jew f’ pazjenti infettati b’ HIV (ara sezzjoni 4. 5).
Most drug interaction studies with saquinavir have been completed with unboosted Invirase or unboosted saquinavir soft capsules (Fortovase).
Ħafna mill- istudji ta ’ interazzjoni ma ’ mediċini b’ saquinavir tlestew b ’ Invirase mhux msaħħaħ jew b’ kapsuli rotob ta ’ saquinavir mhux imsaħħaħ (Fortovase).
A limited number of studies have been completed with ritonavir boosted Invirase or ritonavir boosted saquinavir soft capsules.
Numru limitat ta ’ studji ġew kompluti b’ kapsuli rotob ta ’ saquinavir msaħħaħ b’ ritonavir jew Invirase msaħħaħ b’ ritonavir.
Observations from drug interaction studies done with unboosted saquinavir might not be representative of the effects seen with saquinavir/ ritonavir therapy.
Osservazzjonijiet minn studji ta ’ interazzjoni li saru b’ saquinavir mhux msaħħaħ jistgħu ma jkunux rappresentattivi ta ’ l- effetti li dehru b’ kura ta ’ saquinavir / ritonavir.
Furthermore, results seen with saquinavir soft capsules may not predict the magnitude of these interactions with Invirase/ ritonavir.
Ukoll, ir- riżultati li dehru b’ kapsuli rotob ta ’ saquinavir jistgħu ma jipprevedux il- qawwa ta ’ dawn l- interazzjonijiet ma ’ Invirase/ ritonavir.
The metabolism of saquinavir is mediated by cytochrome P450, with the specific isoenzyme CYP3A4 responsible for 90% of the hepatic metabolism.
Il- metaboliżmu ta ’ saquinavir huwa medjat miċ- ċitokromju P450 bl- iżoenżima speċifiku CYP3A4 responsabbli għal 90% tal- metaboliżmu mill- fwied.
Additionally, in vitro studies have shown that saquinavir is a substrate and an inhibitor for P-glycoprotein (P-gp).
Ukoll, studji in vitro wrew li saquinavir huwa sottostrat u inibitur għal glikoprotejina- P (P- gp).