FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP reviewed the evidence, including the opinions of experts in the field of medicines safety, and concluded that aneuploidy could occur with M2 at levels not much greater than those seen after recommended doses of thiocolchicoside taken by mouth.
Maltese: Is-CHMP irreveda l-evidenza, inklużi l-fehmiet ta' esperti fil-qasam tas-sigurtà tal-mediċini, u kkonkluda li l-anewplojdija tista' sseħħ b'M2 f'livelli mhux ħafna ogħla minn dawk li dehru wara dożi rakkomandati ta' thiocolchicoside mill-ħalq.
English: This followed new evidence from experimental studies carried out by a marketing authorisation holder which suggested an effect on chromosomes by a metabolite of thiocolchicoside.
Maltese: Dan kien ġej wara evidenza ġdida minn studji sperimentali li saru minn detentur tal-awtorizzazzjoni għat-tqegħid fis-suq li ssuġġeriet effett fuq ilkromożomi minn metabolit ta' thiocolchicoside.
English: • It is not recommended for longer-term treatment of chronic conditions.
Maltese: • Mhuwiex rakkomandat għall-kura fit-tul ta' kondizzjonijiet kroniċi.
English: Thiocolchicoside is used as a muscle relaxant in the treatment of painful muscular conditions.
Maltese: Thiocolchicoside huwa rilassant tal-muskoli li ġie awtorizzat permezz ta' proċeduri nazzjonali f'diversi
English: • New evidence has shown that thiocolchicoside is broken down in the body into a substance called M2, which in sufficient amounts can affect the genetic material of the cells.
Maltese: • Evidenza ġdida wriet li thiocolchicoside jitkisser fil-ġisem f'sustanza magħrufa bħala M2, li f'ammonti suffiċjenti tista' taffettwa l-materjal ġenetiku taċ-ċelloli.
English: • Prescribers will be sent a letter giving them further information on the restriction of indication of systemic thiocolchicoside.
Maltese: • It-tobba se jirċievu ittra b'aktar informazzjoni dwar ir-restrizzjoni tal-indikazzjoni ta' thiocolchicoside sistemiku.
English: Preparations for local application to the skin, which do not produce substantial levels of M2 in the body, are not affected by this review.
Maltese: Preparazzjonijiet għall-applikazzjoni lokali lill-ġilda, li ma jipproduċux livelli sostanzjali ta' M2 fil-ġisem, mhumiex affettwati minn din ir-reviżjoni.
English: • In order to minimise the amount of M2 produced in the body, and therefore any associated risks, medicines containing thiocolchicoside are now only recommended for short-term use as an addition to other treatment for pain due to permanent tightening of the muscles where there are problems with the spine, in adults and teenagers from 16 years of age.
Maltese: • Sabiex jiġi minimizzat l-ammont ta' M2 prodott fil-ġisem, u b'hekk kwalunkwe riskju assoċjat, mediċini li fihom thiocolchicoside issa huma rakkomandati biss għall-użu għal żmien qasir bħala żieda ma' kura oħra għall-uġigħ minħabba ebusija permanenti tal-muskoli fejn ikun hemm problemi bl-ispina tad-dahar, f'adulti u adolexxenti minn 16-il sena 'l fuq.
English: • Thiocolchicoside is a medicine used in some EU countries for conditions associated with muscle pain.
Maltese: • Thiocolchicoside huwa mediċina li tintuża f'xi pajjiżi tal-UE għall-kondizzjonijiet marbuta ma' wġigħ fil-muskoli.
English: The Italian medicines regulatory authority therefore requested the CHMP to carry out a full assessment of the benefit-risk balance of systemic medicines containing thiocolchicoside, and issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the European Union.
Maltese: Għalhekk l-awtorità regolatorja tal-mediċini Taljana talbet lis-CHMP iwettaq valutazzjoni sħiħa tal-bilanċ benefiċċju-riskju ta' mediċini sistemiċi li fihom thiocolchicoside, u joħroġ opinjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq tagħhom għandhomx jinżammu, jiġu varjati, sospiżi jew irtirati fl-Unjoni Ewropea.
English: These medicines are now recommended only as an add-on treatment for painful muscle contractures (permanent tightening of the muscle tissue) resulting from spinal conditions in adults and adolescents 16 years of age or older.
Maltese: Dawn il-mediċini issa huma rakkomandati biss bħala kura miżjuda għal kontrazzjonijiet muskolari li jikkawżaw l-uġigħ (ebusija permanenti tat-tessut tal-muskoli) li ġejjin minn kondizzjonijiet tas-sinsla tad-dahar fl-adulti u adolexxenti minn 16-il sena 'l fuq.
English: Thiocolchicoside is a muscle relaxant that has been authorised by national procedures in several EU Member States1 for use by mouth or injection into the muscles in the treatment of painful muscular disorders.
Maltese: Stati Membri tal-UE 1 għall-użu mill-ħalq jew b'injezzjoni ġol-muskoli fil-kura ta' disturbi muskolari li jikkawżaw l-uġigħ.
English: The Committee concluded that in the light of current evidence the benefit-risk for the medicine remained positive provided appropriate risk-mitigating measures were taken, including restricting the maximum dose and duration of use and contra-indicating use during pregnancy and lactation and in children.
Maltese: Il-Kumitat ikkonkluda li fid-dawl talevidenza attwali l-benefiċċju-riskju għall-mediċina baqa' pożittiv sakemm ittieħdu miżuri xierqa għallmitigazzjoni tar-riskju, inkluż li d-doża massima u t-tul tal-użu u l-użu kontraindikat waqt it-tqala u ttreddigħ u fit-tfal jiġu ristretti.
English: • Thiocolchicoside-containing medicines are also available for application to the skin but these do not produce the same levels of M2 in the body and are not thought to affect the genetic material of cells.
Maltese: • Mediċini li fihom thiocolchicoside huma wkoll disponibbli għall-applikazzjoni fuq il-ġilda iżda dawn ma jipproduċux l-istess livelli ta' M2 fil-ġisem u mhumiex maħsuba li jaffettwaw il-materjal ġenetiku taċ-ċelloli.
English: 25, Boulevard de l'Amiral Bruix F-75016
Maltese: MEDA Pharma S.A.S. 25, Boulevard de l'Amiral Bruix F-75016
English: Intravenous use Intrapleural use Intraperitoneal use
Maltese: Użu intraperitoneali
English: MEDA A/S Askerveien 61 NO-1384
Maltese: In-Norveġja MEDA A/S Askerveien 61
English: MEDA Pharma S.A.S.
Maltese: MEDA Pharma S.p.A.
English: MEDA Oy Vaisalantie 4 FIN-02130 Espoo
Maltese: Il-Finlandja MEDA Oy Vaisalantie 4
English: Elsep 2 mg/ml, solution à diluer pour perfusion
Maltese: 2 mg/ml, solution à diluer pour perfusion
English: Annex I List of the names, pharmaceutical forms, strength of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Maltese: mod ta' amministrazzjoni, Detenturi tal-Awtorizzazzjoni għat-Tqegħid fisSuq fl-Istati Membri
English: Iceland
Maltese: Italy
English: Concentrate for solution for infusion or solution for intrapleural or intraperitoneal use
Maltese: Konċentrat għal soluzzjoni għallinfużjoni jew soluzzjoni għal użu intraplewrali jew intraperitoneali
English: Greece
Maltese: Spanja
English: confusion (very rare), hyperhidrosis (rare)
Maltese: konfużjoni (rari ħafna), iperidrosi (rari)
English: In vitro experiments in human liver microsomes and human hepatocytes did not suggest significant inhibition or induction of other CYP isoenzymes (CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP1A2, CYP3A4).
Maltese: Esperimenti in vitro b'mikrosomi tal-fwied uman u epatoċiti umani ma tawx x'jifhem li jkun hemm xkiel jew tqaqil sinifikanti ta' isoenżimi oħra ta' CYP (CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP1A2, CYP3A4).
English: Very rare side effects …confusion, severe allergic reaction (allergic shock)
Maltese: Effetti sekondarji rari ħafna …konfużjoni, reazzjoni allerġika severa (xokk allerġiku)
English: Hypersensitivity reactions:
Maltese: Reazzjonijiet ta' sensittività eċċessiva:
English: SUMMARY OF PRODUCT CHARACTERISTICS (TOLPERISONE-CONTAINING ORAL FORMULATIONS)
Maltese: TAL-PRODOTT (FORMULAZZJONIJIET ORALI
English: Pharmacokinetic drug interaction studies with the CYP2D6 substrate dextromethorphan indicate that tolperisone co-administration may increase the blood levels of drugs which are metabolised dominantly by CYP2D6 such as thioridazine, tolterodine, venlafaxine, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine.
Maltese: Studji ta' interazzjoni twettqu biss f'adulti bis-sustrat ta' CYP2D6 dextromethorphan li jindika li l-għoti konġunt ta' tolperisone jista' jżid il-livelli ta' mediċini fid-demm li huma metabolizzati prinċipalment b'CYP2D6 bħal thioridazine, tolterodine, venlafaxine, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine.
English: 4.8 Undesirable effects
Maltese: 4.8 Effett mhux mixtieqa
English: Symptomatic treatment of post-stroke spasticity in adults.
Maltese: Trattament sintomatiku għal spasitiċità ta' wara l-puplesija fl-adulti.
English: During post marketing experience with medicinal products containing tolperisone (the active substance of {invented name}) the most frequently reported side effects were hypersensitivity reactions.
Maltese: Waqt l-esperjenza ta' wara t-tqegħid fis-suq ta' prodotti mediċinali li fihom tolperisone (is-sustanza attiva ta' {isem ivvintat}) l-aktar effetti mhux mixtieqa rapportati ta' spiss kienu reazzjonijiet ta' sensittivita eċċessiva.
English: The bioavailability of tolperisone is decreased when taken without food, therefore consistent administration in relation to meals is recommended (see also sections 4.2 and 5.2).
Maltese: Il-bijodisponibilità ta' tolperisone titnaqqas meta jittieħed mingħajr ikel, għalhekk l-għoti konsistenti fir-rigward t'ikel huwa rakkomandat (ara wkoll sezzjonijiet 4.2 u 5.2).
English: Hypersensitivity to the active substance tolperisone or to the chemically similar eperisone or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva tolperisone jew għal sustanzi kimikament simili għal epirisome jew kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1
English: Although tolperisone is a centrally acting compound, it does not induce sedation.
Maltese: Għalkemm tolperisone huwa kompost li jaġixxi b'mod ċentrali, ma jikkaġunax sedazzjoni.
English: Tolperisone does not influence the CNS effects of alcohol.
Maltese: Tolperisone ma jinfluwenzax l-effetti tas-SNĊ minn alkoħol.
English: In post-marketing data, hypersensitivity reactions associated with tolperisone administration account for about 50-60% of the reported cases.
Maltese: F'tagħrif ta' wara t-tqegħid fs-suq, reazzjonijiet ta' sensittività eċċessiva bl-għoti ta' tolperisone kienu jgħoddu għal madwar 50-60 % tal-każijiet rapportati.
English: Patients who experience dizziness, somnolence, disturbance in attention, epilepsy, blurred vision or muscular weakness while taking tolperisone should consult his/her doctor.
Maltese: Pazjenti li jesperjenzaw sturdament, ħedla, disturbi fl-attenzjoni, epilessija, vista mċajpra jew dgħufija muskolari waqt li jkunu qed jieħdu tolperisone għandhom jikkonsultaw it-tabib tagħhom.
English: It is for the treatment of the pathologically elevated skeletal muscle tone after a stroke in adults.
Maltese: Jintuża bħala trattament għal ton muskolari skeletriku patoloġiku ogħla wara puplesija fl-adulti.
English: High-fat meal increases the bioavailability of orally administered tolperisone by approx. 100% and increases the peak plasma concentration by approx. 45% as compared with fasting condition, delaying time to peak by approx. 30 minutes.
Maltese: Ikliet b'ammont għoli ta' grass jżidu l-bijodisponibilità ta' tolperisone mogħti mill-ħalq b'madwar 100% u jżidu l-konċentrazzjoni l-aktar għolja fil-plażma b'madwar 45% meta mqabbla mal-kondizzjoni ta' sawm, li jittardja l-ħin tal-ogħla konċentrazzjoni b'madwar 30 minuta.
English: Annex III Relevant sections of the summary of product characteristics and package leaflet
Maltese: ANNESS III SEZZJONIJIET TAL-PARTIJIET RILEVANTI
English: If you experience dizziness, somnolence, disturbance in attention, epilepsy, blurred vision or muscular weakness while taking {invented name} consult your doctor.
Maltese: Jekk inti tesperjenza sturdament, ħedla, disturb fl-attenzjoni, epilessija, vista mċajpra jew dgħufija muskolari waqt li qed tieħu {isem ivvintat} ikkonsulta t-tabib tiegħek.
English: Females, patients in older age, or treated with concomitant medications (mainly with NSAIDs) seem to be at a higher risk to experience hypersensitivity reactions.
Maltese: Nisa, pazjenti ta' età akbar, jew pazjenti trattati b'mediċini oħra fl-istess waqt (prinċipalment b'NSAIDs) jidhru li huma f'riskju ogħla li jesperjenzaw reazzjonijiet ta' sensittività eċċessiva.
English: Symptoms may include erythema, rash, urticaria, pruritus, angioedema, tachycardia, hypotension or dyspnoea.
Maltese: Is-sintomi jistgħu jinkludu eritema, raxx, ħakk, anġjoedema, pressjoni baxxa u dispnea.
English: Patients with kidney impairment
Maltese: Tfal u adolexxenti
English: During post marketing experience with tolperisone the most frequently reported adverse reactions were hypersensitivity reactions.
Maltese: Waqt l-esperjenza ta' wara t-tqegħid fis-suq b'tolperisone l-aktar reazzjonijiet avversi frekwenti rapportati kienu reazzjonijiet ta' sensittività eċċessiva.
English: PACKAGE LEAFLET (TOLPERISONE-CONTAINING ORAL FORMULATIONS) [the wording below should be inserted in the relevant sections]
Maltese: TAL-PAKKETT (FORMULAZZJONIJIET GĦALL-ĦALQ LI FIHOM TOLPERISONE) [il-kliem t'hawn isfel għandu jiddaħħal fs-sezzjonijiet rilevanti]
English: Increase in tolperisone exposure is not expected after concomitant administration of CYP2D6 substrates and/or other drugs due to the diversity of the metabolic pathways of tolperisone.
Maltese: Żieda fl-espożizzjoni għal tolperisone mhux mistenni jseħħ wara l-għoti flimkien ta' sustrati ta' CYP2D6 u/jew mediċini oħra minħabba d-diversità ta' rotot metaboliċi ta' tolperisone.
English: What {invented name} is and what it is used for Tolperisone is a medication that acts on the central nervous system.
Maltese: Tolperisone huwa mediċina li jaġixxi fuq is-sistema nervuża ċentrali.
English: Early signs of hypersensitivity are: flushing, rash, severe itching of the skin (with raised lumps), wheezing, difficulty in breathing with or without swelling of the face, lips, tongue and/or throat, difficulty in swallowing, fast heart beat, low blood pressure, fast decrease in blood pressure.
Maltese: Sinjali bikrija ta' sensittività eċċessiva huma: fwawar, raxx, ħakk sever tal-ġilda (b'infafet elevati), tħarħir, diffikultà biex tieħu n-nifs bi jew mingħajr nefħa fil-wiċċ, ix-xofftejn, l-ilsien u/jew il-griżmejn, diffikultà biex tibla', qalb tħabbat b'mod mgħaġġel, pressjoni baxxa tad-demm, tnaqqis ta' malajr fil-pressjoni tad-demm.
English: How to take Tolperisone film-coated tablet
Maltese: TAS-SOMMARJU TAL-KARATTERISTIĊI
English: If you have a known allergy for lidocaine you have a higher risk to be allergic to tolperisone.
Maltese: Jekk għandek allerġija magħrufa għal lidocaine inti tinsab f'riskju ogħla li tkun allerġiku għal tolperisone.
English: Therefore the preparation can be combined with sedatives, hypnotics and tranquillisers.
Maltese: Għalhekk it-taħlita tista' tiġi kkombinata b'sedattivi, ipnotiċi u kalmanti.
English: Your regular medical follow-up will include frequent monitoring of liver function and your condition during therapy with Tolperisone because a higher frequency of adverse events has been observed in this patient group.
Maltese: L-insegwitu mediku regolari tiegħek ser jinkludi monitoraġġ frekwenti tal-funzjoni tal-kliewi u l-kondizzjoni tiegħek waqt it-terapija b'{isem ivvintat} minħabba li frekwenza ogħla ta' każijiet avversi ġew osservati f'dan il-grupp ta' pazjenti.
English: Experience in patients with hepatic impairment is limited and a higher frequency of adverse events has been observed in this patient group.
Maltese: L-esperjenza f'pazjenti b'indeboliment tal-kliewi hija limitata u frekwenza akbar ta' każijiet avversi ġiet osservata f'dan il-grupp ta' pazjenti.
English: Hypersensitivity reactions ranged from mild skin reactions to severe systemic reactions (e.g. allergic shock).
Maltese: Reazzjonijiet ta' sensittività eċċessiva kienu jvarjaw minn reazzjonijiet ħfief tal-ġilda għal reazzjonijiet sistemiċi severi (eż. xokk allerġiku).
English: Rare side effects …increased sweating
Maltese: Effetti sekondarji rari …żieda fl-għaraq
English: The safety profile of tolperisone containing tablets is supported by data on more than 12,000 patients.
Maltese: Il-profil ta' sigurta ta' pilloli li fihom tolperisone huwa sostnut b'tagħrif miġbur minn fuq aktar minn 12,000 pazjent.
English: If you are allergic to the active substance (tolperisone hydrochloride) or to medicines containing eperisone or any of the other ingredients of this medicine (listed in section 6).
Maltese: Jekk inti allerġiku għas-sustanza attiva (tolperisone hydrochloride) jew għal mediċni li fihom eperisone jew għal xi sustanzi oħra ta' din il-mediċina (elenkati fis-sezzjoni 6).
English: Although tolperisone is a centrally acting compound, its potential to cause sedation is low.
Maltese: Għalkemm tolperisone huwa kompost li jaġixxi b'mod ċentrali, il-potenzjal tiegħu li jikkaġuna sedazzjoni huwa baxx.
English: If you have severe kidney problems you should not take this medicine.
Maltese: Jekk għandek problemi severi tal-kliewi inti m'għandekx tieħu din il-mediċina.
English: Lancet, 2002; 360: 1803-10 3 Dada OA et al. A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria.
Maltese: 360: 1803-10 3 Dada OA et al. A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria.
English: 2 von Hertzen H et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial.
Maltese: Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial.
English: 4 Creinin MD et al. Progesterone receptor modulator for emergency contraception: a randomized controlled trial.
Maltese: Progesterone receptor modulator for emergency contraception: a randomized controlled trial.
English: Whereas
Maltese: N tqaliet
English: Table 1: Meta-analysis on three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al.,
Maltese: Tabella 1: Meta-analiżi fuq tliet studji tad-WHO (Von Hertzen et al., 1998 u 2002;
English: Both meta-analyses excluded intake later than 72 hours after unprotected intercourse (i.e. offlabel use of LNG) and women who had further acts of unprotected intercourse.
Maltese: Iż-żewġ meta-analiżijiet eskludew teħid aktar tard minn 72 siegħa wara kopulazzjoni mhux protetta (jiġifieri użu off-label ta' LNG) u n-nisa li kellhom atti ulterjuri ta' kopulazzjoni mhux protetta.
English: N pregnancies 1
Maltese: Anness IV
English: In contrast, in the two comparative studies of Creinin and colleagues (2006) and Glasier and colleagues (2010), primarily including Caucasian women, a reduced contraceptive efficacy was observed with increasing body weight or BMI (Table
Maltese: B'kuntrast, fiż-żewġ studji komparattivi ta' Creinin and colleagues (2006) u Glasier and colleagues (2010), li primarjament jinkludu nisa Kawkasi, kien
English: Further, the data of the meta-analysis should be presented in section 5.1 of the SmPC.
Maltese: Barra minn hekk, id-dejta tal-meta-analiżijiet għandha tiġi ppreżentata fis-sezzjoni 5.1 tal-SmPC.
English: Further, the data of the two meta-analyses should be reflected in section 5.1 of the SmPC.
Maltese: Barra minn hekk, id-dejta taż-żewġ meta-analiżijiet għandha tiġi riflessa fis-sezzjoni 5.1 tal-SmPC.
English: The full EPAR for Viracept can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: • rifampicin (used to treat tuberculosis);
Maltese: • ir-rifampiċina (użata fil-kura tat-tuberkulożi);
English: Viracept is an antiviral medicine.
Maltese: Viracept hu mediċina antivirali.
English: EPAR summary for the public nelfinavir
Maltese: Sommarju tal-EPAR għall-pubbliku nelfinavir
English: CD4 cell counts increased by 150 and 95 cells/mm3, respectively.
Maltese: L-għadd taċ-ċelloli CD4 żdiedu b'150 u 95 ċellola/mm3 rispettivament.
English: It is available as an oral powder (50 mg per gram) and as tablets (250 mg).
Maltese: Tiġi fi trab orali (50 mg f'kull gramma) u f'pilloli (250 mg).
English: The active substance in Viracept, nelfinavir, is a protease inhibitor.
Maltese: Is-sustanza attiva f'Viracept, in-nelfinavir, hija inibitur tal-proteażi.
English: • St John's wort (a herbal preparation used to treat depression);
Maltese: • il-fexfiex tar-raba' (St John's wort - preparazzjoni erbali użata fil-kura tad-depressjoni);
English: Viracept is a medicine containing the active substance nelfinavir.
Maltese: Viracept hu mediċina li fiha s-sustanza attiva nelfinavir.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Viracept on 22 January 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Viracept valida fl-Unjoni Ewropea kollha fit-22 ta' Jannar 1998.
English: This is a summary of the European public assessment report (EPAR) for Viracept.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR).
English: In the second study, viral load had fallen by more than 99% in the patients taking the higher dose of Viracept, compared with 95% in those taking the comparator medicines.
Maltese: Fit-tieni studju, it-tagħbijiet virali naqsu b'iktar minn 99% filpazjenti li kienu qed jieħdu d-doża ogħla ta' Viracept, apparagun ma' 95% f'dawk li kienu qed jieħdu lmediċini li tqabbel magħhom.
English: 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.
Maltese: Għal pazjenti ikbar minn 13-il sena, id-doża ta' Viracept rakkomandata hi 1,250 mg darbtejn kuljum jew 750 mg tliet darbiet kuljum, meħuda mal-ikel.
English: • omeprazole (used to reduce stomach acid levels);
Maltese: • l-omeprażolu (użat biex inaqqas l-livelli tal-aċidità fl-istonku);
English: Viracept has also been studied in 37 children.
Maltese: Viracept ġie studjat ukoll f'37 tifel u tifla.
English: In the first study, Viracept in combination with stavudine (another antiviral medicine) was compared with stavudine alone in 308 patients who had not taken stavudine or a protease inhibitor in the past.
Maltese: Fl-ewwel studju, Viracept u l-istavudina (mediċina antivirali oħra) flimkien tqabblu mal-istavudina waħdidha fi 308 pazjenti li qatt ma kienu ħadu l-istavudina jew xi inibitur tal-proteażi.
English: 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.
Maltese: 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.
English: 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.
Maltese: Viracept ġie studjat flimkien ma' mediċini antivirali oħra f'żewġ studji ewlenin li fihom ħadu sehem 605 pazjenti li kienu għalqu t-13-il sena jew iktar u li kienu infettati bl-HIV.
English: What is Viracept?
Maltese: X'inhu Viracept?
English: 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).
Maltese: Jintuża flimkien ma' mediċini oħra fit-trattament ta' adulti, adolexxenti jew tfal ikbar minn tliet snin li jkunu infettati bil-virus uman tal-immunodefiċenzja (HIV1), virus li jikkawża s-sindromu mill-immunodefiċenzja akkwiżita (AIDS).