qanastek/EMEA-V3 huggingface dataset:
Vimpat may cause dizziness, which could increase the risk of accidental injury or a fall.
128 Vimpat jista ’ jikkawża sturdament, li jista ’ jżid ir- riskju ta ’ korriment jew waqgħa.
121 A small number of people being treated with anti-epileptics such as lacosamide have had thoughts of harming or killing themselves.
Numru żgħir ta ’ nies li jkunu fuq kura b ’ mediċini ta ’ kontra l- epilessija bħal lacosamide kellhom ħsibijiet li jweġġgħu jew joqtlu lilhom infushom.
Using Vimpat with food and drink You may take Vimpat with or without food.
Meta tuża Vimpat ma ’ l- ikel u max- xorb Tista ’ tieħu Vimpat kemm ma ’ l- ikel kif ukoll mingħajr.
Pregnancy and breast-feeding It is not recommended to take Vimpat if you are pregnant, as the effects of Vimpat on pregnancy and the unborn baby are not known.
Tqala u Treddigħ Mhux irrikkmandat li tieħu Vimpat jekk inti tqila, għaliex l- effetti ta ’ Vimpat fuq il- tqala u t- tarbija ġol- ġuf mhumiex magħrufin.
Important information about some of the ingredients of Vimpat This medicinal product contains 2.6 mmol (or 59.8 mg) sodium per vial.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Vimpat Dan il- prodott mediċinali fih 2. 6 mmol (jew 59. 8 mg) ta ’ sodju f’ kull fjala.
To be taken into consideration for patients on a controlled sodium diet.
Din għandha titqies f ’ dawk il- pazjenti fuq dieta bis- sodju kontrollat.
HOW TO USE VIMPAT
KIF GĦANDEK TUŻA VIMPAT
The solution for infusion is an alternative form of treatment for a short period of time, when Vimpat can't be taken by mouth.
Is- soluzzjoni għall- infużjoni hija forma alternattiva ta ’ trattament għal perjodu qasir ta ’ żmien, meta Vimpat ma jistax jittieħed mill- ħalq.
It will be admin istered into a vein by a health care professional.
Dan jingħata ġol- vina minn professjonista tal- kura tas - saħħa.
It is possible to switch directly from oral administration to infusion and the other way around.
Huwa possibli li tibdel direttament mit- teħid mill- ħalq għal infużjoni u bil- kontra.
Your total daily dose and frequency of administration remain the same.
Id- doża totali ta ’ kuljum u l- frekwenza tat- teħid jibqgħu l- istess.
Dosage Vimpat must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
Dożaġġ Vimpat għandu jingħata darbtejn kuljum, darba filgħodu u darba filgħaxija, bejn wieħed u ieħor fl - istess ħin kuljum.
The treatment with Vimpat starts usually with a dose of 100 mg daily given half (50 mg) in the morning and half (50 mg) in the evening.
Vimpat jintuża bħala trattament fit- tul.
The daily maintenance dose is between 200 mg and 400 mg.
It- trattament b’ Vimpat issoltu jibda b’ doża ta ’ 100 mg kuljum, li jingħata nofs (50 mg) filgħodu u nofs (50 mg) filgħaxija.
Your doctor may use a different dose if you have problems with your kidneys.
It- tabib tiegħek jista ’ juża doża differenti jekk inti għandek problemi fil- kliewi tiegħek.
How Vimpat is given to you Vimpat is administered as an infusion into a vein (intravenously) by a healthcare professional.
129 Kif tingħata Vimpat Vimpat jingħata bħala infużjoni ġol- vina minn professjonista tal- kura tas- saħħa.
It is infused over 15-60 minutes.
Huwa jingħata fuq 15- 60 minuta
122 Duration of the treatment with Vimpat solution for infusion Your doctor will decide for how many days you will receive the infusions.
It- tul tat- trattament b ’ Vimpat soluzzjoni għall- infużjoni It- tabib tiegħek ser jiddeċiedi għal kemm il- ġurnata inti ser titgħata l- infużjoni.
There is experience with twice daily infusions of Vimpat up to 5 days.
Hemm esperjenza b’ infużjoni ta ’ darbtejn kuljum ta ’ Vimpat għal mhux iżjed minn 5 tijiem.
For the long term treatment Vimpat tablets and syrup are available.
Għat- trattament fit- tul, hemm il- pilloli u l- mistura Vimpat.
If you stop using Vimpat If your doctor decides to stop your treatment with Vimpat, he/she will decrease the dose step by step.
Jekk tieħu Vimpat aktar milli suppost Jekk tieħu Vimpat aktar milli suppost, kellem lit- tabib tiegħek.
This is to prevent your symptoms from coming back again or becoming worse.
Jekk tinsa tieħu Vimpat Jekk tinsa ’ tieħu doża bi ftit sigħat, ħu d- doża hekk kif tiftakar.
Do not use Vimpat after the expiry date which is stated on the carton and vial.
Tużax Vimpat wara d- data ta ’ skadenza li tidher fuq il- kartuna u il- folja.
Each vial of Vimpat solution for infusion must be used only once (single use).
Kull fjala ta ’ Vimpat soluzzjoni għall- infużjoni trid tintuża darba biss (użu ta ’ darba).
Only clear solution free from particles and discoloration should be used.
Soluzzjoni ċara mingħajr frak u bla diskolorazzjoni biss għandha tintuża.
1 ml Vimpat solution for infusion contains 10 mg lacosamide.
1 ml Vimpat soluzzjoni għall- injezzjoni fiħ 10 mg lacosamide.
1 vial contains 20 ml Vimpat solution for infusion equivalent to 200 mg lacosamide.
Fjala waħda fiha 20 ml Vimpat soluzzjoni għall- infużjoni ekwivalenti għal 200 mg lacosamide.
The other ingredients are: sodium chloride, hydrochloric acid, water for injection.
L- ingredjenti l- oħra huma: sodium chloride, hydrochloric acid, ilma għall- injezzjoni.
What Vimpat looks like and contents of the pack Vimpat 10 mg/ml solution for infusion is a clear, colourless solution.
Vimpat 10 mg/ ml soluzzjoni għall- infużjoni huja soluzzjoni ċara, bla kulur.
Vimpat solution for infusion is available in packages of 1 vial, containing 20 ml.
Vimpat soluzzjoni għall- infużjoni instabu f’ pakketti ta ’ fjala waħda, li fiha 20 ml.
Deutschland UCB GmbH Tel: +49 (0)2173 48 4847
Deutschland UCB GmbH
Norge UCB Nordic A/S Tel: +45 / 32 46 24 00
Tel: +45 / 32 46 24 00
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
3H
The following information is intended for medical or healthcare professionals only
It- tagħrif li ġej huwa intenzjonat għal professjonisti mediċi jew tal- kura tas- saħħa biss
Vimpat solution for infusion can be administered without further dilution, or may be diluted with the following solutions:
Is- soluzzjoni għall- infużjoni Vimpat jista ’ jittieħed mingħajr ma jiġi dilwit aktar, jew jista ’ jiġi dilwit b’ dawn is- soluzzjonijiet li ġejjin:
0.9% sodium chloride 9 mg/ml (0.9%), 5% glucose 50 mg/ml or lactated Ringer’s solution.
0. 9% sodium chloride 9 mg/ ml (0. 9%), 5% glucose 50 mg/ ml jew
Each vial of Vimpat solution for infusion must be used only once (single use).
Kull fjala ta ’ soluzzjoni għall- infużjoni Vimpat għandha tintuża darba biss (għall- użu ta ’ darba).
Any unused solution should be discarded (see section 3).
Kull soluzzjoni li ma tintużax għandha tintrema (ara sezzjoni 3).
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.
Huwa jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqa, biex jaslu għar- rakkomandazzjonijiet tagħhom 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 inti teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (huwa wkoll parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
What is Viracept?
X' inhu Viracept?
Viracept is a medicine containing the active substance nelfinavir.
Viracept hu mediċina li fiha s- sustanza attiva nelfinavir.
It is available as an oral powder (50 mg per gram) and as blue, oblong tablets (250 mg).
Huwa disponibbli bħala trab orali (50 mg f' kull gramma) u bħala pilloli oblongi blu (250 mg).
What is Viracept used for?
Għalxiex jintuża Viracept?
Viracept is an antiviral medicine.
Viracept hu mediċina antivirali.
It is used in combination with other antiviral medicines to treat adults, adolescents and children over three years of age who are infected with human immunodeficiency virus (HIV-1), the virus that causes acquired immune deficiency syndrome (AIDS).
Jintuża flimkien ma 'mediċini oħra fit- trattament ta' adulti, adolexxenti jew tfal li jkollhom iktar minn tliet snin li jkunu infettati bil- virus uman tal - immunodefiċenzja (HIV- 1), virus li jikkawża s- sindromu mill- immunodefiċenzja akkwiżita (AIDS).
Doctors should only prescribe Viracept to patients who have already taken medicines in the same class as Viracept (protease inhibitors) once they have looked at the antiviral medicines the patient has taken before and the likelihood that the virus will respond to the medicine.
It- tobba għandhom jippreskrivu Viracept biss lil pazjenti li jkunu ħadu mediċini mill- istess klassi ta 'Viracept (inibituri tal- proteażi) wara li qabel jkunu analizzaw x' mediċini jkun ħa l- pazjent u l - probabilità li l- virus jirrispondi għall- mediċina.
How is Viracept used?
Kif jintuża Viracept?
Treatment with Viracept should be initiated by a doctor who has experience in the treatment of HIV infection.
It- trattament b' Viracept għandu jinbeda minn tabib li jkollu esperjenza fit- trattament tal- infezzjoni tal - HIV.
For patients aged over 13 years, the recommended dose of Viracept is 1,250 mg twice a day or 750 mg three times a day, taken with food.
Għal pazjenti ta 'iktar minn 13- il sena, id- doża ta' Viracept rakkomandata hi 1, 250 mg darbtejn kuljum jew 750 mg tliet darbiet kuljum, meħuda mal- ikel.
The dose for children aged three to 13 years depends on their body weight.
Id- doża għat- tfal ta 'bejn tlieta u 13- il sena tiddependi minn kemm ikunu jiżnu.
The oral powder can be used in patients who are unable to swallow capsules.
It- trab orali jista 'jintuża f' pazjenti li ma jkunux jistgħu jibilgħu kapsuli.
The appropriate amount of powder is measured using the special scoops supplied in the pack, and the powder mixed with milk or formula.
L- ammont ta 'trab meħtieġ għandu jitkejjel permezz ta' kuċċarini apposta fornuti fil- pakkett, u t- trab għandu jitħallat mal- ħalib jew b' formula.
Viracept should be used with caution in patients who have problems with their liver or kidneys.
Viracept għandu jintuża b' kawtela għal pazjenti li jkollhom problemi fil- fwied jew fil- kliewi.
How does Viracept work?
Kif jaħdem Viracept?
The active substance in Viracept, nelfinavir, is a protease inhibitor.
Is- sustanza attiva f' Viracept, nelfinavir, hija inibitur tal- proteażi.
It blocks an enzyme called protease that is involved in the reproduction of HIV.
Timblokka enzima li tissejjaħ proteażi li għandha sehem 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 mblukkata, il- virus ma jirripproduċix ruħu bħas- soltu, u dan inaqqas il- firxa tal- infezzjoni.
Viracept, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Viracept, meħud flimkien ma 'mediċina antivirali oħra, inaqqas l- ammont ta' HIV fid- demm u jżommu f' livell baxx.
Viracept 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.
Viracept ma jfejjaqx infezzjoni tal- HIV jew tal- AIDS, iżda jista 'jtawwal iż- żmien qabel ma ssir ħsara lis- sistema immunitarja u lill- iżvilupp ta' infezzjonijiet u mardiet marbuta mal- AIDS.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Fl- ewwel studju, Viracept 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Viracept has been studied in combination with other antiviral medicines in two main studies involving 605 patients aged 13 years or more, who were infected with HIV.
Reproduction is authorised provided the source is acknowledged flimkien ma 'stavudine (mediċina antivirali oħra) tqabbel ma' stavudine waħdu fi 308 pazjenti li ma kinux ħadu stavudine jew inibitur tal- proteażi qabel.
In the second study, Viracept, in combination with zidovudine and lamivudine (other antiviral medicines) was compared with the combination of zidovudine and lamivudine in 297 treatment-naïve patients (who had not taken any antiviral medicines to treat HIV infection before).
Fit- tienu studju, Viracept, flimkien ma 'zidovudine u lamivudine (mediċini antivirali oħra) tqabbel mal- kombinazzjoni ta' zidovudine u lamivudine f' 297 pazjent li ma kinux ħadu mediċini għat- trattament tal- infezzjoni tal- HIV qabel l - istudju).
The main measures of effectiveness were the change in the levels of HIV in the blood (viral load) and the change in the number of CD4 T-cells in the blood (CD4 cell count).
Il- mezz ewlieni tal- kejl tal- effikaċja kien it- tibdil fil- livelli tal- HIV fid- demm (tagħbija virali) u t- tibdil fin- numru ta 'ċelloli- T CD4 fid- demm (numru taċ- ċelloli CD4).
Three studies have compared the effectiveness of dosing Viracept twice and three times a day, in combination with stavudine and lamivudine in 635 patients.
Tliet studji qabblu l- effikaċja tad- dożi ta 'Viracept meħud darbtejn u tliet darbiet kuljum, flimkien ma' stavudine u lamivudine f' 635 pazjent.
Most of these patients had not taken protease inhibitors in the past.
Ħafna minn dawn il- pazjenti ma kinux ħadu inibituri tal- proteażi qabel.
Viracept has also been studied in 37 children.
Viracept ġie studjat ukoll f' 37 tifel u tifla.
What benefit has Viracept shown during the studies?
X' benefiċċji ta 'Viracept intwerew f' dawn l- istudji?
Viracept, in combination with other antiviral medicines, was more effective than the comparator medicines in both main studies.
Viracept, flimkien ma 'mediċini antivirali oħra, kien iktar effikaċi minn mediċini li tqabbel magħhom fiż- żewġ studji ewlenin.
After 24 weeks, Viracept brought about greater reductions in viral loads and increases in CD4 cell counts than the comparator medicines.
Wara 24 ġimgħa, Viracept wassal għal tnaqqis ikbar fit- tagħbijiet virali u żidiet fin- numru taċ- ċelloli CD4 meta mqabbel mal- mediċini li tqabbel magħhom.
There were no differences between the two doses of Viracept.
Ma kienx hemm differenzi bejn iż- żewġ dożi ta 'Viracept.
In the second study, viral loads had fallen by more than 99% in the patients taking the higher dose of Viracept, compared with 95% in those taking the comparator medicines.
Fit- tieni studju, it- tagħbijiet virali naqsu b' iktar minn 99% fil- pazjenti li kienu qed jieħdu d- doża għolja ta 'Viracept, meta mqabbla ma' 95% f' dawk li kienu qed jieħdu l- mediċini li tqabbel magħhom.
CD4 cell counts increased by 150 and 95 cells/ mm3, respectively.
In- numru taċ- ċelloli CD4 żdiedu b' 150 u 95 ċellola/ mm3, rispettivament.
Viracept brought about similar reductions in viral load whether it was taken twice or three times a day.
Viracept wassal għal tnaqqis simili fit- tagħbija virali kemm meta ttieħed darbtejn kuljum u kemm meta ttieħed tliet darbiet kuljum.
The study in children showed that the medicine produced similar levels of the active substance in the blood in children and adults, with similar side effects and effectiveness.
L- istudju fit- tfal wera li l- mediċina pproduċiet livelli simili tas - sustanza attiva fid- demm fit- tfal u fl- adulti, b' effetti sekondarji u b' effikaċja simili.
What is the risk associated with Viracept?
X' inhu r- riskju assoċjat ma 'Viracept?
The most common side effect with Viracept (seen in more than 1 patient in 10) is diarrhoea.
L- iktar effett sekondarju komuni b’ Viracept (li deher f' iktar minn pazjent wieħed minn kull għaxra) hu d- dijarrea.
For the full list of all side effects seen with Viracept, see the Package Leaflet.
Għal- lista sħiħa ta 'effetti sekondarji rrappurtati b' Viracept, ara l- Fuljett ta' Tagħrif.
Viracept should not be used in people who may be hypersensitive (allergic) to nelfinavir or any of the other ingredients.
Viracept m' għandux jintuża minn persuni li huma allerġiċi għal nelfinavir jew għal xi sustanza oħra tiegħu.
Viracept should not be used in patients who are taking any of the following medicines: • rifampicin (used to treat tuberculosis); • St John’ s wort (a herbal preparation used to treat depression); • omeprazole (used to reduce stomach acid levels); • medicines that are broken down in the same way as Viracept and are harmful at high levels in the blood.
Viracept m' għandux jintuża minn pazjenti li jkunu qed jieħdu dawn il- mediċini: • rifampicin (użat fit- trattament tat- tuberkulożi); • fexfiex tar- raba '(St John’ s wort) (preparazzjoni tal- ħxejjex użata fit- trattament tad- depressjoni); • omeprazole (użat biex inaqqas l- livelli ta' aċidità fl- istonku); • mediċini li jitkissru bl- istess mod ta 'Viracept u li jagħmlu l- ħsara meta l- livelli tagħhom fid- demm ikunu għolja.
Doctors should consider using alternatives to medicines that speed up the breakdown of Viracept, such as phenobarbital and carbamazepine (used to treat epilepsy), in patients taking Viracept.
It- tobba għandhom jikkunsidraw l- użu ta ’ alternattivi għall- mediċini li jħaffu t- tkissir ta ’ Viracept, bħal fenobarbital u karbamażepina (phenobarbital u carbamazepine – użati fit- trattament tal - epilessija), f’ pazjenti li jieħdu Viracept.
Caution is needed when Viracept is taken at the same time as other medicines.
Meta Viracept jingħata ma 'mediċini oħra, dan għandu jsir b' kawtela kbira.
As with other anti-HIV medicines, patients taking Viracept 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 mediċini oħra ta 'kontra l- HIV, il- pazjenti li jkunu qed jieħdu Viracept jista' jkollhom riskju ta 'lipodistrofija (tibdiliet fid- distribuzzjoni tax- xaħam fid- demm), osteonekrożi (mewt ta' tessut tal - għadam) jew sindromu tar- rijattivazzjoni immunitarja (sintomi ta 'infezzjoni kkawżati minn sistema immunitarja li tkun qed tirkupra).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Viracept.
Il- pazjenti li jkollhom problemi bil- fwied (inkluż l- epatite B u Ċ) jista 'jkollhom riskju elevat ta' ħsara lill- fwied meta jieħdu Viracept.
Why has Viracept been approved?
Għaliex ġie approvat Viracept?
The Committee for Medicinal Products for Human Use (CHMP) decided that Viracept’ s benefits are greater than its risks in antiretroviral combination treatment of HIV-1 infected adults, adolescents and children of three years of age and older.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Viracept għandu iktar benefiċċji milli riskji meta użat flimkien ma 'sustanzi antiretrovirali oħra fit- trattament ta' adulti, adolexxenti u tfal li għalqu t- tliet snin.
The Committee recommended that Viracept be given marketing authorisation.
Il- Kumitat irrakkomanda li Viracept jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Viracept was originally authorised under ‘ Exceptional Circumstances’, because, for scientific reasons, limited information was available at the time of approval.
Viracept oriġinarjament kien awtorizzat taħt 'Ċirkostanzi Eċċezzjonali', għax, għal raġunijiet xjentifiċi, kien hemm biss tagħrif limitat disponibbli fi żmien l- approvazzjoni.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 1 August 2001.
Billi l- kumpanija pprovdiet it - tagħrif addizzjonali mitlub, iċ - 'Ċirkostanzi Eċċezzjonali' intemmu fl- 1 ta 'Awwissu 2001.
2/ 3 Other information about Viracept:
Tagħrif ieħor dwar Viracept:
The European Commission granted a marketing authorisation valid throughout the European Union for Viracept to Roche Registration Limited on 22 January 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Viracept valida fl- Unjoni Ewropea kollha lil Roche Registration Limited fit- 22 ta 'Jannar 1998.
The marketing authorisation was renewed on 22 January 2003 and on 22 January 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq iġġeddet fit- 22 ta 'Jannar 2003 u fit- 22 ta' Jannar 2008.
The full EPAR for Viracept can be found here.
2/ 3 L- EPAR sħiħ għal Viracept jista ’ jiġi kkonsultat hawn.
VIRACEPT 50 mg/ g oral powder.
VIRACEPT 50 mg/ g trab orali.
The bottle contains 144 g of oral powder.
Il- flixkun fih 144 g ta ’ trab orali.
Each gram of oral powder contains nelfinavir mesilate corresponding to 50 mg of nelfinavir.
Kull gramma ta ’ trab orali fiha nelfinavir mesilate li jikkorrispondi għal 50 mg ta ’ nelfinavir.
- Contains sucrose palmitate:
- Fiħ sucrose palmitate:
10.0 mg per gram of oral powder.
10. 0 mg kull gramma ta ’ trab orali.
10.0 mg of sucrose palmitate,
10. 0 mg ta ’ sucrose palmitate, li
which is an ester, theoretically corresponds to maximally 5.9 mg of sucrose when fully hydrolysed.
huwa ester, tejoretikament jikkorrispondi għall- massimu ta ’ 5. 9 mg ta ’ sucrose meta jiġi idrolizzat kompletament.
- Contains aspartame (E951):
- Fiħ aspartame (E951):
20.0 mg of aspartame per gram of oral powder.
20. 0 mg ta ’ aspartame f’ kull gramma ta ’ trab orali.
- Contains potassium:
- Fiħ potassium:
50.0 mg of dibasic potassium phosphate corresponding to 22.5 mg of
50. 0 mg ta ’ dibasic potassium phosphate li jikkorrispondi għal 22. 5 mg ta ’
potassium per gram of oral powder.
potassium kull gramma ta ’ trab orali.
White to off-white amorphous powder.
Trab amorfu abjad għal offwajt.
VIRACEPT is indicated in antiretroviral combination treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children of 3 years of age and older.
VIRACEPT huwa indikat fit- terapija mħallta antiretrovirali għat- trattament ta ’ adulti, adoloxxenti u tfal li għandhom aktar minn 3 snin, infettati bil- vajrus ta ’ l- immunodefiċjenza uman (HIV- 1).
In protease inhibitor (PI) experienced patients the choice of nelfinavir should be based on individual viral resistance testing and treatment history.
F’ pazjenti b’ esperjenza ta ’ l- inibitur tal- protease (PI), l- għażla ta ’ nelfinavir għandha tkun ibbażata fuq testijiet tar- reżistenza virali u fuq l- istorja tat- trattament tal- pazjent.
Therapy with VIRACEPT should be initiated by a physician experienced in the management of HIV infection.
Terapija b’ VIRACEPT għandha tinbeda minn tabib b’ esperjenza fl- immaniġġjar ta ’ infezzjoni b’ HIV.
VIRACEPT should always be ingested with food (see section 5.2).
VIRACEPT għandu jittieħed dejjem ma ’ l- ikel (ara sezzjoni 5. 2).
Patients older than 13 years:
Pazjenti li għandhom aktar minn 13- il sena:
VIRACEPT 250 mg tablets are recommended for adults and older children (see Summary of Product Characteristics for VIRACEPT 250 mg tablets).
Il- pilloli VIRACEPT ta ’ 250 mg huma rakkomandat għal adulti u tfal kbar (ara s- Sommarju tal- Karatteristiċi tal- Prodott għall- pilloli ta ’ VIRACEPT ta ’ 250 mg).
The recommended dose of VIRACEPT 50 mg/ g oral powder is 1250 mg twice a day (BID) or 750 mg three times a day (TID), for patients unable to take tablets.
Id- doża rakkomandata ta ’ VIRACEPT 50 mg/ g trab orali hija ta ’ 1250 mg mogħtija darbtejn kuljum (BID) jew 750 mg mogħtija tliet darbiet kuljum (TID), għal pazjenti li ma jistgħux jieħdu l- pilloli.
All patients older than 13 years should take either 5 level scoops of the blue 5 gram spoon twice daily or 3 level scoops of the blue 5 gram spoon three times daily.
Il- pazjenti kollha li għandhom aktar minn 13- il sena għandhom jieħdu jew 5 kuċċarini mhux imburġati mill- kuċċarina l- blu tal- 5 grammi darbtejn kuljum, jew 3 kuċċarini mhux imburġati mill- kuċċarina l- blu tal- 5 grammi tliet darbiet kuljum.
The efficacy of the BID (twice daily) regimen has been evaluated versus the TID (three times daily) regimen primarily in patients naïve to PIs (see section 5.1)
L- effikaċja tal- kors BID (darbtejn kuljum) kienet evalwata kontra l- kors TID (tliet darbiet kuljum), primarjament f’ pazjenti li ma ħadux PIs (ara Sezzjoni 5. 1).
Patients aged 3 to 13 years: for children, the recommended starting dose is 50-55 mg/ kg BID or if using a TID regimen, 25 – 30 mg/ kg body weight per dose.
Pazjenti b’ età minn 3 snin sa 13- il sena: għat- tfal, id- doża rakkomandata tal- bidu hija ta ’ 50- 55 mg/ kg BID jew jekk qed tuża l- kors TID, 25 – 30 mg/ kg ta ’ piż tal- ġisem kull doża.
For children able to take tablets,
Għat- tfal li jistgħu
2 VIRACEPT tablets may be administered instead of the oral powder (see Summary of Product Characteristics for VIRACEPT tablets).
2 jieħdu l- pilloli, il- pilloli ta ’ VIRACEPT jistgħu jingħataw minflok it- trab orali (ara is- Sommarju tal - Karatteristiċi tal- Prodott għall- pilloli ta ’ VIRACEPT).
The recommended dose of VIRACEPT oral powder to be administered BID to children aged 3 to 13 years, using a combination of both the white 1 gram and the blue 5 gram scoop is shown in the following table.
Id- doża rakkomandata tat- trab ta ’ VIRACEPT trab orali li trid tingħata BID lil tfal li għandhom minn 3 sa 13- il sena, billi tuża taħlita kemm tal- kuċċarina l- bajda tal- 1 gramma u kemm tal - kuċċarina l- blu tal- 5 grammi hija murija fil- lista li jmiss.
The prescriber should advise the patient to use the handle of the second scoop to scrape off extra powder and obtain a level scoop.
Min qed jippreskrivi l- mediċina għandu jagħti parir lill- pazjent biex juża l- manku tat- tieni kuċċarina biex ineħħu t- trab żejjed biex ikollu kuċċarina watja.
Dose to be administered two times a day to children aged 3 to 13
Doża li għandha tingħata darbtejn kuljum lil tfal b’ età minn 3 snin sa 13- il sena
Body Weight of the patient
Piż tal- Ġisem tal -
Blue Scoop 5 gram
Kuċċarina Blu 5 grammi
White Scoop 1 gram
Kuċċarina Bajda gramma waħda
Total grams of Powder per dose
grammi ta ’ Trab kull doża
7.5 to 8.5 kg 8.5 to 10.5 kg
7. 5 sa 8. 5 kg 8. 5 sa 10. 5 kg
plus
flimkien ma ’
10.5 to 12 kg 12 to 14 kg 14 to 16 kg 16 to 18 kg 18 to 22 kg over 22 kg
10. 5 sa 12 kg 12 sa 14 kg 14 sa 16 kg 16 sa 18 kg 18 sa 22 kg ’ l fuq minn 22 kg
plus plus plus plus plus
flimkien ma ’ flimkien ma ’ flimkien ma ’ flimkien ma ’ flimkien ma ’
The recommended dose of VIRACEPT oral powder to be administered TID to children aged 3 to 13 years, using a combination of both the white 1 gram and the blue 5 gram scoop is shown in the following table.
Id- doża rakkomandata tat- trab ta ’ VIRACEPT 50 mg/ g trab orali li trid tingħata TID lil tfal li għandhom minn 3 sa 13- il sena, billi tuża taħlita kemm tal- kuċċarina l- bajda ta ’ gramma u kemm tal- kuċċarina l- blu tal- 5 grammi hija murija fil- lista li jmiss.
The prescriber should advise the patient to use the handle of the second scoop to scrape off extra powder and obtain a level scoop.
Min qed jippreskrivi l- mediċina għandu jagħti parir lill- pazjent biex juża l- manku tat- tieni kuċċarina biex ineħħi t- trab żejjed biex ikollu kuċċarina watja.
Dose to be administered three times a day to children aged 3 to 13
Doża li għandha tingħata darbtejn kuljum lil tfal b’ eta minn 3 snin sa 13- il sena
White Scoop 1 gram
grammi
Total grams of Powder per dose
Trab kull doża
7.5 to 8.5 kg 8.5 to 10.5 kg
8. 5 kg 10. 5 kg
10.5 to 12 kg 12 to 14 kg 14 to 16 kg 16 to 18 kg 18 to 23 kg over 23 kg
10. 5 sa 12 kg 1 12 sa 14 kg 1 14 sa 16 kg 1 16 sa 18 kg 1
plus plus plus plus plus
flimkien ma ’
1 2 3 4 - -
3
The oral powder may be mixed with water, milk, formula, soy formula, soy milk, dietary supplements, or pudding.
It- trab orali jista ’ jitħallat ma ’ l- ilma, ħalib, trab tal- ħalib, trab tal- ħalib tas- sojja, ħalib tas- sojja, supplimenti tad- dieta, jew pudina.
It is recommended that VIRACEPT 50 mg/ g oral powder mixed in these media be used within 6 hours.
Huwa rakkomandat li VIRACEPT 50 mg/ g trab orali imħallat f’ dawn l- affarijiet jintuża sa 6 siegħat.
Dosing media not recommended, due to taste, includes any acidic food or juice (e. g., orange juice, apple juice or apple sauce).
Affarijiet li jistgħu jitħalltu mad- doża li mhumiex rakkomandati minħabba t- togħma, jinkludu kull ikel aċiduż jew meraq (eż. meraq tal- larinġ, meraq tat- tuffieħ jew zalza tat- tuffieħ).
Do not add water to bottles of VIRACEPT 50 mg/ g oral powder.
Iżżidx ilma fil- fliexken ta ’ VIRACEPT 50 mg/ g trab orali.
Renal and hepatic impairment: there are no data specific for patients with renal impairment and therefore specific dosage recommendations cannot be made.
M’ hemm l- ebda informazzjoni dwar pazjenti b’ mard tal- kliewi u għalhekk rakkommandazzjonijiet speċifiċi dwar id- dożaġġ ma jistgħux jingħataw.
Nelfinavir is principally metabolised and eliminated by the liver.
Nelfinavir huwa prinċipalment immetabolat u eliminat mill- fwied.
There are not sufficient data from patients with liver impairment and therefore specific dose recommendations cannot be made (see section 5.2).
M’ hemmx informazzjoni biżżejjed fuq pazjenti b’ mard tal- kliewi u għalhekk rakkommandazzjonijiet speċifiċi dwar id- dożaġġ ma jistgħux jingħataw
Caution should be used when administering VIRACEPT to patients with impaired renal or hepatic function.
Attenzjoni trid tingħata meta VIRACEPT jingħata lill- pazjenti b’ mard tal- kliewi jew tal- fwied.
Co-administration with medicinal products with narrow therapeutic windows and which are substrates of CYP3A4 [e. g., terfenadine, astemizole, cisapride, amiodarone, quinidine, pimozide, triazolam, orally administered midazolam (for caution on parenterally administered midazolam, see section 4.5), ergot derivatives; see section 4.5].
L- għotja flimkien ma ’ prodotti mediċinali oħra li għandhom indiċi terapewtiku żgħir u li huma sottostrati ta ’ CYP3A4 [eż. terfenadine, astemizole, cisapride, amiodarone, quinidine, pimozide, triazolam, midazolam li jingħata mill- ħalq (għal attenzjoni dwar midazolam mogħti b’ mod parenterali, ara sezzjoni 4. 5), derivattivi ta ’ ergot; ara sezzjoni 4. 5].
Co-administration with rifampicin (see section 4.5).
L- għotja flimkien ma ’ rifampicin (ara sezzjoni 4. 5).
John’ s wort (Hypericum perforatum) must not be used while taking nelfinavir due to the risk of decreased plasma concentrations and reduced clinical effects of nelfinavir (see section 4.5).
John’ s wort [Hypericum perforatum] m’ għandhomx jintużaw meta nelfinavir ikun qed jittieħed minħabba r- riskju ta ’ konċentrazzjonijiet tal- plażma mnaqqsa u effetti kliniċi mnaqqsa ta’ nelfinavir (ara Sezzjoni 4. 5).
VIRACEPT should not be co-administered with omeprazole due to a reduction in exposure to nelfinavir and its active metabolite M8.
VIRACEPT m’ għandux jingħata flimkien ma ’ omeprazole minħabba tnaqqis fl- espożizzjoni għal nelfinavir u l- metabolit attiv tiegħu M8.
This may lead to a loss of virologic response and possible resistance to VIRACEPT (see section 4.5).
Dan jista ’ jwassal għal telf tar- rispons viroloġiku u l - possibbiltà ta ’ reżistenza għal VIRACEPT (ara sezzjoni 4. 5).
Patients should be instructed that VIRACEPT is not a cure for HIV infection, that they may continue to develop infections or other illnesses associated with HIV disease, and that VIRACEPT has not been shown to reduce the risk of transmission of HIV disease through sexual contact or blood contamination.
Il- pazjenti għandhom jiġu mfhema li VIRACEPT mhux kura għall- infezzjoni b’ HIV, li jistgħu jibqgħu jiżviluppaw infezzjonijiet jew mard ieħor assoċjat mal- marda ta ’ l- HIV, u li VIRACEPT ma ntweriex li jnaqqas ir- riskju li tixtered il- marda ta ’ l- HIV permezz ta ’ kuntatt sesswali jew kontaminazzjoni tad - demm.
Immune reactivation syndrome:
Sindromu tar- riattivazzjoni immuni:
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.
F’ pazjenti nfetti b’ HIV b’ defiċjenza immuni severa fil- ħin li tinbeda t- terapija antiretrovirali kombinata (CART), tista ’ sseħħ reazzjoni inflammatorja għall- patoġeni mingħajr sintomi jew patoġeni residwali, opportunistiċi li tista ’ tikkawża kondizzjonijiet kliniċi serji, jew aggravar tas- sintomi.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterium infections, and Pneumocystis carinii pneumonia.
Eżempji rilevanti huma retinite kkawżata minn cytomegalovirus, infezzjonijiet ġeneralizzati u/ jew lokalizzati b’ mycobacterium, u pnewmonja kkawżata minn Pneumocystis carinii.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Kull sintomu inflammatorju għandu jiġi vvalutat u għandha tinbeda kura skond il- bżonn.
The safety and efficacy of nelfinavir has not been established in patients with significant underlying liver disorders.
Is- sigurtà u l- effikaċja ta ’ nelfinavir ma kinetx stabbilita f’ pazjenti b’ mard prinċipali sinifikattiv tal - fwied.
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 ttrattati b’ terapija mħallta antiretrovirali huma f’ riskju ikbar ta ’ effetti mhux mixtieqa 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 mogħtija flimkien 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’ marda tal- fwied li kienet teżisti minn qabel li tinkludi epatite attiva kronika għandhom frekwenza miżjuda ta ’ anormalitajiet fil- funzjoni tal- fwied waqt it- terapija mħallta antiretrovirali u għandhom ikunu osservati skond il- prattika normali.
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 ikkunsidrat.
The use of nelfinavir in patients with moderate hepatic impairment has not been studied.
L- użu ta ’ nelfinavir f’ pazjenti b’ indeboliment moderat tal- fwied ma ġiex studjat.
In the absence of such studies, caution should be exercised, as increases in nelfinavir levels and/ or increases in liver enzymes may occur.
Fin- nuqqas ta ’ dawn l- istudji, għandha tittieħed attenzjoni, peress li jista ’ jkun hemm żjieda fil- livelli ta ’ nelfinavir u/ jew żjieda fl- enżimi tal- fwied.
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).
Il- pazjenti għandhom jiġu avżati biex iffitxu
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
4 parir mediku jekk ikollhom esperjenza ta ’ weġgħat u uġigħ fil- ġogi, għebusija fil- ġogi jew dffikultà fil- moviment.
Since nelfinavir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodiaylisis or peritoneal dialysis.
Peress li nelfinavir huwa mwaħħal ħafna mal- proteini fil- plażma, mhux probabbli li jiġi mneħħi b’ mod sinifikanti b’ emodijalisi jew b’ dijalisi tal- peritonew.
Therefore, no special precautions or dose adjustments are required in these patients.
Għalhekk, mhux meħtieġa prekawzjonijiet speċjali jew aġġustamenti fid- doża f’ dawn il- pazjenti.
Caution is advised whenever VIRACEPT is co- administered with medicinal products which are inducers or inhibitors and/ or substrates of CYP3A4; such combinations may require dose adjustment (see also sections 4.3, 4.5 and 4.8).
Taħlita ma ’ prodotti mediċinali oħra: attenzjoni hija meħtieġa kull meta VIRACEPT jingħata flimkien ma ’ prodotti mediċinali li huma sustanzi li jinduċu u/ jew jinibixxu sottostrati ta ’ CYP3A4; meta dawn jingħataw flimkien jeħtieġ ssir aġġustament tad- doża (ara wkoll sezzjonijiet 4. 3, 4. 5 u 4. 8).
The HMG (hydroxy-3-methyl-glutaryl) -CoA reductase inhibitors simvastatin and lovastatin are highly dependent on CYP3A4 for metabolism, thus concomitant use of VIRACEPT with simvastatin or lovastatin is not recommended due to an increased risk of myopathy including rhabdomyolysis.
L- inibituri ta ’ HMG (hydroxy- 3- methyl- glutaryl) - CoA reductase, simvastatin u lovastatin, huma dipendenti ħafna fuq is- CYP3A4 għall- metaboliżmu, għaldaqstant l- użu flimkien ta ’ VIRACEPT ma ’ simvastatin jew ma ’ lovastatin mhuwiex rakkomandat minħabba r- riskju miżjud ta ’ mijopatija li jinkludi r- rabdomijolosi.
Caution must also be exercised if VIRACEPT is used concurrently with atorvastatin, which is metabolised to a lesser extent by CYP3A4.
Attenzjoni trid tingħata wkoll jekk VIRACEPT jintuża flimkien ma ’ atorvastatin, li huwa immetabolat fi grad inqas minn CYP3A4.
In this situation a reduced dose of atorvastatin should be considered.
F’ din is- sitwazzjoni, doża mnaqqsa ta ’ atorvastatin għandha tkun ikkunsidrata.
If treatment with a HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended (see section 4.5).
Jekk it- trattament b’ inibituri ta ’ HMG- CoA reductase huwa indikat, pravastatin jew fluvastatin huma rakkomandati.
Particular caution should be used when prescribing sildenafil in patients receiving PIs, including nelfinavir.
Attenzjoni partikulari għandha tingħata meta sildenafil ikun preskritt lill- pazjenti li qed jirċievu l- PIs, inkluż nelfinavir.
Co-administration of a PI with sildenafil is expected to substantially increase sildenafil concentration and may result in an increase in sildenafil associated adverse events, including hypotension, visual changes, and priapism.
L- għoti flimkien ta ’ PI ma ’ sildenafil huwa mistenni li jżid sostanzjalment il - konċentrazzjonijiet ta’ sildenafil u jista ’ jirriżulta fi żjieda ta ’ effetti mhux mixtieqa assoċjati ma ’ sildenafil, li jinkludu pressjoni baxxa ħafna, tibdil fil- viżta u priapiżmu (ara sezzjoni 4. 5).
Potent inducers of CYP3A (e. g., phenobarbital and carbamazepine) may reduce nelfinavir plasma concentrations.
Sustanzi li jinduċu potenti ta ’ CYP3A4 (eż. phenobarbital u carbamazepine) jistgħu wkoll inaqqsu l - konċentrazzjonijiet tal- plażma ta ’ nelfinavir.
Physicians should consider using alternatives when a patient is taking VIRACEPT (see sections 4.3 and 4.5).
It- tobba għandhom jikkunsidraw li jużaw alternattivi meta pazjent ikun qed jieħu VIRACEPT (ara sezzjonijiet 4. 3 u 4. 5).
The absorption of nelfinavir may be reduced in situations where the gastric pH is increased irrespective of cause.
L- assorbiment ta ’ nelfinavir jista ’ jonqos f’ sitwazzjonijiet fejn il- pH ta ’ l- istonku tiżdied, tkun xi tkun il- kawża.
When nelfinavir is co-administered with omeprazole this may lead to a loss of virologic response and therefore concomitant use is contra-indicated (see section 4.3 and 4.5).
Meta nelfinavir jingħata flimkien ma ’ omeprazole dan jista ’ jwassal għal telf tar- rispons viroloġiku u għalhekk l- użu flimkien huwa kontra- indikat (ara sezzjoni 4. 3 u 4. 5).
Caution is recommended when nelfinavir is co-administered with other proton pump inhibitors (see section 4.5).
Kawtela hija rakkomandata meta nelfinavir jingħata flimkien ma ’ inibituri tal- pompi tal- protoni oħra (ara sezzjoni 4. 5).
VIRACEPT may lead to a decreased AUC of phenytoin; therefore phenytoin concentrations should be monitored during concomitant use with VIRACEPT (see section 4.5).
VIRACEPT jista ’ jwassal għal tnaqqis ta ’ l- AUC ta ’ phenytoin; għalhekk il- konċentrazzjonijiet ta‘ phenytoin għandhom ikunu osservati waqt l- użu flimkien ma ’ VIRACEPT (ara sezzjoni 4. 5).
Methadone AUC may be decreased when co-administered with VIRACEPT; therefore upward adjustment of methadone dose may be required during concomitant use with VIRACEPT (see section 4.5).
L- AUC ta ’ methadone jista ’ jitnaqqas meta mogħti flimkien ma ’ VIRACEPT; għalhekk aġġustament fid- doża ta ’ methadone jista ’ jkun meħtieġ waqt l- użu flimkien ma ’ VIRACEPT (ara sezzjoni 4. 5).
Co-administration of the combination oral contraceptive containing norethindrone and 17 α -ethinylestradiol with VIRACEPT resulted in a decrease in AUC of the contraceptive -medicinal product.
L- għoti flimkien ta ’ kontraċettivi orali li fihom norethindrone u 17 α- ethinyl estradiol flimkien ma ’ VIRACEPT irriżulta fi tnaqqis ta ’ l- AUC tal- prodott mediċinali kontraċettiv.
Alternative contraceptive measures should therefore also be considered (see section 4.5).
Għalhekk għandhom ikunu kkunsidrati miżuri kontraċettivi alternattivi (ara sezzjoni 4. 5).
New onset diabetes mellitus, hyperglycaemia or exacerbation of existing diabetes mellitus has been reported in patients receiving PIs.
Dijabete mellitus u ipergliċemija: dijabete mellitus fil- bidu, ipergliċemija jew taħrix ta ’ dijabete mellitus eżistenti kien irrappurtat f’ pazjenti li qed jirċievu l- PIs.
In some of these the hyperglycaemia was severe and in some cases also associated with ketoacidosis.
F’ xi ftit minn dawn il- pazjenti, l - ipergliċemija kienet serja u f’ xi ftit każijiet kienet ukoll assoċjata ma ’ ketoaċidosi.
Many patients had confounding medical conditions, some of which required therapy with agents that have been associated with the development of diabetes or hyperglycaemia.
Ħafna pazjenti kellhom kondizzjonijiet mediċi mħawwdin, li xi ftit minnhom kienu jeħtieġu terapija b’ mediċini li kienu assoċjati ma ’ l- iżvilupp tad- dijabete mellitus jew ta ’ l- ipergliċemija.
Patients with haemophilia:
Pazjenti bl- emofilja:
There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in haemophiliac patients type A and B treated with PIs.
Kien hemm rapporti ta ’ żjieda fit- telf tad- demm, li jinkludu ematomi u emartrosi spontanji tal- ġilda, f’ pazjenti emofiliċi tat- tip A u B ittrattati bil- PIs.
In some patients additional factor VIII was given.
F’ xi pazjenti l- fattur addizzjonali VIII kien mogħti.
In more than half of the reported cases, treatment with PIs was continued or reintroduced if treatment had been discontinued.
F’ aktar minn nofs il- każijiet irrappurtati, it- trattament bil- PIs tkompla jew inbeda mill- ġdid jekk it- trattament kien imwaqqaf.
A causal relationship has been evoked, although the mechanism of action has not been elucidated.
Konnessjoni kawżali kienet evokata, għalkemm il - mekkaniżmu ta ’ l- azzjoni ma kienx eluċidat.
Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.
Pazjenti emofiliċi għandhom għalhekk ikunu mgħarrfa bil- possibbiltà ta ’ żjieda fit- telf tad- demm.
Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
Lipodistrofija: it- terapija mħallta antiretrovirali kienet assoċjata mat- tqassim mill- ġdid ta ’ xaħam tal - ġisem (lipodistrofija) f’ pazjenti infettati b’ HIV.
The long-term consequences of these events are currently unknown.
Il- konsegwenzi fit- tul ta ’ dawn l- okkorrenzi mhumiex magħrufa bħalissa.
Knowledge about the mechanism is incomplete.
Il- konoxxenza dwar il- mekkaniżmu hija inkompleta.
Clinical examination should include evaluation for physical signs of fat
Konnessjoni bejn il -
5 redistribution.
5 lipomatosi tal- vixxri u PIs u l- lipoatrofija u l- Inibituri ta ’ Nucleoside Analogue Reverse Transcriptase (NRTIs) kienet ipotizzata.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Konsiderazzjoni għandha tingħata għall- qies tal- lipidi tas- serum u tal - glukowż fid- demm ta ’ meta wieħed ikun sajjem.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Mard tal- lipidi għandu jkun immaniġġat kif inhu klinikament xieraq (ara sezzjoni 4. 8.).
VIRACEPT oral powder contains aspartame (E951) as a sweetening agent.
VIRACEPT trab orali fih aspartame (E951) bħala sustaanza li tagħti togħma ħelwa.
Aspartame provides a source of phenylalanine and, therefore, may not be suitable for persons with phenylketonuria.
Aspartame jipprovdi sorsi ta ’ phenylalanine u għalhekk, jista ’ ma jkunx xieraq għall- persuni b’ phenylketonuria.
VIRACEPT oral powder contains potassium.
VIRACEPT trab orali fih potassium.
VIRACEPT oral powder also contains sucrose.
VIRACEPT trab orali fiħ ukoll sucrose.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltese insufficiency should not take this medicine.
Pazjenti b’ problemi ereditarji rari ta ’ intolleranza għal fructose, assorbiment ħażin ta ’ glucose- galactose jew insuffiċjenza ta ’ sucrase- isomaltese m’ għandhomx jieħdu din il- mediċina.
See section 2 and 6.1 for further information on excipients.
Ara sezzjoni 2 u 6. 1 għal aktar informazzjoni dwar is- sustanzi mhux attivi.
Please refer to Table 1 and Table 2 for interactions of nelfinavir with selected compounds, Table 1 for impact on the pharmacokinetics of the co-administered compound, Table 2 for the impact of other drugs on pharmacokinetics of nelfinavir.
Jekk jogħġbok irreferi għal Tabella 1 u Tabella 2 għall- interazzjonijiet ta ’ nelfinavir ma ’ sustanzi magħżula, Tabella 1 għall- effett fuq il- farmakokinetika tas- sustanza mogħtija fl- istess waqt, Tabella 2 għall- effett ta ’ mediċini oħra fuq il- farmakokinetika ta ’ nelfinavir.
Nelfinavir is primarily metabolised via the cytochrome P450 isoenzymes CYP3A and CYP2C19 (see section 5.2).
Nelfinavir huwa primarjament immetabolizzat miċ- ċitokromju P450 isoenżimi CYP3A u CYP2C19 (ara sezzjoni 5. 2).
Co-administration with the following medicinal products that are substrates for CYP3A4 and which have narrow therapeutic windows is contraindicated (see section 4.3 and below): terfenadine, astemizole, cisapride, amiodarone, quinidine, ergot derivatives, pimozide, oral midazolam and triazolam.
L- għoti flimkien mal- prodotti mediċinali li ġejjin li huma sottostrati ta ’ CYP3A4 u li għandhom raġġ terapewtiku żgħir huwa kontra- indikat (ara sezzjoni 4. 3 u isfel): terfenadine, astemizole, cisapride, amiodarone, quinidine, derivattivi ta ’ ergot, pimozide,, midazolam orali u triazolam.
Caution should be used when co-administering medicinal products that induce CYP3A or potentially toxic medicinal products which are themselves metabolised by CYP3A (see section 4.3 and below).
Attenzjoni għandha tintuża meta prodotti mediċinali li jinduċu CYP3A jew prodotti mediċinali potenzjalment tossiċi jingħataw flimkien, li huma nnifishom huma mmetabolati minn CYP3A4 (ara sezzjoni 4. 3 u isfel).
Based on in vitro data, nelfinavir is unlikely to inhibit other cytochrome P450 isoforms at concentrations in the therapeutic range.
Informazzjoni bbażata fuq studji in vitro turi li nelfinavir x’ aktarx ma jinibixxix isoformi oħra taċ- ċitokromju P450 f’ konċentrazzjonijiet fil- firxa terawpewtika.
Other antiretrovirals:
Antiretrovirali oħra:
Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs):
Inibituri ta ’ Nucleoside Analogue Reverse Transcriptase (NRTIs):
Clinically significant interactions have not been observed between nelfinavir and nucleoside analogues (specifically zidovudine plus lamivudine, stavudine, and stavudine plus didanosine).
Interazzjonijiet reċiproċi klinikament sinifikattivi ma kinux osservati bejn nelfinavir u l- analogi ta ’ nucleoside (speċifikament zidovudine ma ’ lamivudine, stavudine, u stavudine ma ’ didanosine).
At present, there is no evidence of inadequate efficacy of zidovudine in the CNS that could be associated with the modest reduction in plasma levels of zidovudine when co-administered with nelfinavir.
Bħalissa m’ hemm l- ebda evidenza ta ’ effikaċja inadegwata ta ’ zidovudine f’ CNS li tista ’ tkun assoċjata ma tnaqqis modest fil- livelli tal- plażma ta’ zidovudine meta mogħti flimkien ma ’ nelfinavir.
Since it is recommended that didanosine be administered on an empty stomach, VIRACEPT should be administered (with food) one hour after or more than 2 hours before didanosine.
Billi huwa rakkomandat li didanosine jingħata fuq stonku vojt, VIRACEPT għandu jingħata (ma ’ l - ikel) siegħa wara, jew aktar minn sagħtejn qabel didanosine.
Other Protease Inhibitors (PIs):
Inibituri Oħra ta ’ Protease (PIs):