FrancophonIA/ELRC3.0 huggingface dataset:
English: It must not be taken with ciclosporin, itraconazole, or other medicines known as ‘potent P-glycoprotein inhibitors' (such as quinidine).
Maltese: Din il-mediċina ma għandhiex tittieħed ma' ciclosporin, itraconazole, jew mediċini oħra magħrufa bħala ‘inibituri qawwijin ta' Pglycoprotein' (bħal quinidine).
English: The most common side effect with Sprimeo HCT (seen in between 1 and 10 patients in 100) is diarrhoea.
Maltese: L-effett sekondarju l-aktar komuni ta' Sprimeo HCT (li deher f'bejn pazjent wieħed u 10 minn kull 100) hu dijarrea.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sprimeo HCT on 23 June 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Sprimeo HCT fit-23 ta' Ġunju 2011.
English: It blocks the activity of a human enzyme called renin, which is involved in the production of a substance called angiotensin I in the body.
Maltese: Din timblokka l-attività ta' enzima umana magħrufa bħala renina, li hija relatata mal-produzzjoni ta' sustanza msejħa anġjotensina I fil-ġisem.
English: Sprimeo HCT contains two active substances, aliskiren and hydrochlorothiazide.
Maltese: Sprimeo HCT fih żewġ sustanzi attivi, l-aliskiren u l-idroklorotijażid.
English: Sprimeo HCT in combination with an ‘angiotensin converting enzyme (ACE) inhibitors' or ‘angiotensin receptor blockers' (ARBs) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Maltese: Sprimeo HCT ma għandux jintuża flimkien ma' ‘inibituri ta' enzimi li jikkonvertu l-anġjotensini' (ACE) jew ‘imblokkaturi tar-riċetturi tal-anġjotensini' (ARBs) f'pazjenti bid-dijabete, jew b'indeboliment renali moderat jew sever.
English: Sprimeo HCT is a medicine that contains the active substances aliskiren and hydrochlorothiazide.
Maltese: Sprimeo HCT huwa mediċina li fiha s-sustanzi attivi aliskiren u idroklorotijażid.
English: Most studies involved patients with mild to moderate hypertension and one involved patients with severe hypertension.
Maltese: Il-maġġoranza tal-istudji involviet pazjenti b'ipertensjoni minn ħafifa għal moderata u studju ieħor involva pazjenti b'ipertensjoni gravi.
English: What is Sprimeo HCT?
Maltese: X'inhu Sprimeo HCT?
English: Overall, the company presented the results of nine main studies involving a total of almost 9,000 patients with essential hypertension.
Maltese: B'kollox, il-kumpanija ppreżentat ir-riżultati ta' disa' studji ewlenin li involvew total ta' 9,000 pazjent li jbatu minn ipertensjoni essenzjali.
English: What is the risk associated with Sprimeo HCT?
Maltese: X'inhu r-riskju assoċjat ma' Sprimeo HCT?
English: The company presented information used in the assessment of aliskiren and from the published literature to support its application for Sprimeo HCT, as well as information from additional studies.
Maltese: Il-kumpanija ppreżentat informazzjoni użata fil-valutazzjoni ta' aliskiren u meħuda mil-letteratura ppubblikata għas-sostenn tal-applikazzjoni tagħha għal Sprimeo HCT kif ukoll linformazzjoni meħuda minn studji addizzjonali.
English: Sprimeo HCT must not be used in people who are hypersensitive (allergic) to aliskiren, hydrochlorothiazide, any of the other ingredients or sulfonamides.
Maltese: Sprimeo HCT ma għandux jintuża f'persuni li huma ipersensittivi (allerġiċi) għal aliskiren, għallidroklorotijażide, għal kwalunkwe mis-sustanzi l-oħra jew għas-sulfonamidi.
English: By lowering blood pressure, the risk caused by high blood pressure, such as having a stroke, is reduced.
Maltese: Bit-tnaqqis tal-pressjoni tad-demm, jitnaqqas ir-riskju kkawżat minn pressjoni għolja, bħall-puplesija.
English: For the full list of all side effects reported with Sprimeo HCT, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati bi Sprimeo HCT, ara l-fuljett ta' tagħrif.
English: Why has Sprimeo HCT been approved?
Maltese: Għaliex ġie approvat Sprimeo HCT?
English: Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension.
Maltese: L-idroklorotijażid hija dijuretiku, li huwa tip ieħor ta' trattament tal-ipertensjoni.
English: Patients previously taking only aliskiren or hydrochlorothiazide may need to take the two substances as separate tablets and adjust the doses before switching to Sprimeo HCT.
Maltese: Twettqu tliet studji addizzjonali biex juru li s-sustanzi attivi ġew assorbiti mill-ġisem fl-istess mod bħal meta kienu ttieħdu f'pilloli separati u Sprimeo HCT.
English: Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels).
Maltese: L-anġjotensina I tinbidel flormon anġjotensina II, li hi vasokonstrittur qawwi (sustanza li ddejjaq l-arterji u l-vini).
English: How has Sprimeo HCT been studied?
Maltese: Kif ġie studjat Sprimeo HCT?
English: It must not be used in patients who have had angioedema (swelling under the skin) with aliskiren, hereditary angioedema or angioedema of no obvious cause, who have severe kidney or liver impairment, or whose blood potassium levels are too low or blood calcium levels are too high.
Maltese: Ma għandux jintuża filpazjenti li kellhom anġjoedema (neħfa taħt il-ġilda) bl-aliskiren, anġjoedema ereditarja jew anġjoedema mingħajr kawża ċara, li jkollhom indeboliment gravi fil-kliewi jew fil-fwied, jew li jkollhom livelli ta' potassju fid-demm baxxi wisq jew livelli tal-kalċju għoljin wisq.
English: Elonva (corifollitropin alfa)
Maltese: Elonva (korifollitropina alfa)
English: Further information on Elonva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/elonva.
Maltese: ema.europa.eu/medicines/human/EPAR/elonva.
English: Other information about Elonva
Maltese: Informazzjoni oħra dwar Elonva
English: Elonva contains the active substance corifollitropin alfa.
Maltese: Elonva fih is-sustanza attiva korifollitropina alfa.
English: The active substance in Elonva, corifollitropin alfa, is similar to follicle stimulating hormone (FSH), a natural hormone in the body.
Maltese: Is-sustanza attiva f'Elonva, il-korifollitropina alfa, hija simili għall-ormon follikolu stimulanti (FSH), ormon naturali fil-ġisem.
English: Around 39% of those who received Elonva became pregnant compared with 38% of those treated with follitropin beta.
Maltese: Madwar 39 % ta' dawk li ngħataw Elonva nqabdu tqal meta mqabbla ma' 38 % ta' dawk ikkurati b'follitropin beta.
English: One of the studies involved women weighing 60 kg or less who received a 100-microgram dose of Elonva, and a second study involved women weighing above 60 kg who received a 150-microgram dose.
Maltese: Wieħed mill-istudji involva nisa li jiżnu 60 kg jew inqas li ngħataw doża ta' 100-mikrogramma ta' Elonva, u t-tieni studju involva nisa li jiżnu aktar minn 60 kg li ngħataw doża ta' 150-mikrogramma.
English: What are the risks associated with Elonva?
Maltese: X'inhuma r-riskji assoċjati ma' Elonva?
English: The third study involved women in the age range 35 to 42 years weighing 50 kg or more who were given a 150-microgram dose of Elonva; the main measure of effectiveness in this study was the number of women with a successful early pregnancy, and 24 and 27% of women treated with Elonva and follitropin beta respectively became pregnant.
Maltese: It-tielet studju involva nisa li għandhom bejn il-35 u t-42 sena li jiżnu 50 kg jew aktar li ngħataw doża ta' 150-mikrogramma ta' Elonva; il-kejl ewlieni tal-effikaċja f'dan l-istudju kien in-numru ta' nisa bi tqala bikrija b'suċċess, u 24 u 27 % tan-nisa kkurati b'Elonva u b'follitropin beta rispettivament ħarġu tqal.
English: In three main studies involving 3,292 women who needed to have ovarian stimulation, Elonva treatment has been shown to be as effective as treatment with follitropin beta (an FSH medicine also used to stimulate the ovaries).
Maltese: Fi tliet studji ewlenin li involvew 3,292 mara li kellhom bżonn stimulazzjoni tal-ovarji, il-kura b'Elonva ntweriet li kienet effettiva daqs kura b'follitropin beta (mediċina FSH użata wkoll biex tistimula lovarji).
English: FSH stimulates the production of eggs in the ovaries.
Maltese: L-FSH jistimula l-produzzjoni tal-bajd fl-ovarji.
English: It is used together with a gonadotrophin-releasing hormone (GnRH) antagonist (another type of medicine used in fertility treatments).
Maltese: Jintuża flimkien mal-antagonista (tip ta' mediċina oħra użata fil-kura tal-fertilità) tal-ormon tar-rilaxx tal-gonadotrofina (GnRH).
English: As for all medicines, data on the use of Elonva are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Elonva hija ssorveljata kontinwament.
English: Elonva must not be used in patients with tumours of the ovary, breast, womb, pituitary (a gland located at the base of the brain that produces FSH) or hypothalamus (a region of the brain).
Maltese: Elonva ma għandux jintuża fuq pazjenti li għandhom tumuri fl-ovarji, fis-sider, fil-ġuf, fil-glandola pitwitarja (glandola li qiegħda fil-fond tal-moħħ li tipproduċi l-FSH) jew fl-ipotalamu (parti tal-moħħ).
English: In corifollitropin alfa, a peptide (a short chain of amino acids) is attached to the FSH to prolong its activity in the body.
Maltese: Fil-korifollitropina alfa, peptida (katina żgħira ta' amminoaċidi) teħel mal-FSH biex ittawwal l-attività tiegħu fil-ġisem.
English: The most common side effects with Elonva (which may affect up to 1 in 10 people) are headache, nausea (feeling sick), tiredness, pelvic pain and discomfort, breast tenderness and ovarian hyperstimulation syndrome (OHSS).
Maltese: L-effetti sekondarji l-aktar komuni b'Elonva (li jistgħu jaffettwaw sa persuna waħda minn kull 10) huma uġigħ ta' ras, nawżja (tħossok ma tiflaħx), għeja, uġigħ u skumdità fil-pelvis, irtubija fis-sider u s-sindrome ta' iperstimulazzjoni tal-ovarji (OHSS).
English: It must also not be used in women with abnormal (not menstrual) bleeding from the vagina without a known cause, fibroids or malformations of the womb that would prevent pregnancy, primary ovarian failure, enlarged ovaries or ovaries with cysts, or in women with risk factors for OHSS such as polycystic ovarian syndrome.
Maltese: Lanqas ma għandu jintuża f'nisa b'fsada anormali (mhux menstruwali) mill-vaġina mingħajr kawża magħrufa, fibrojdi jew malformazzjonijiet tal-ġuf li jipprevjenu t-tqala, nuqqas primarju tal-ovarji, ovarji mkabbra jew ovarji b'ċesti, jew f'nisa b'fatturi ta' riskju għall-OHSS bħas-sindrome poliċistika tal-ovarji.
English: Elonva received a marketing authorisation valid throughout the European Union on 25 January 2010.
Maltese: Elonva rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha fil-25 ta' Jannar
English: Seven days after the Elonva injection, if further ovarian stimulation is needed, injections of another medicine similar to Elonva, but suitable for daily injection, may be given.
Maltese: Sebat ijiem wara l-injezzjoni b'Elonva, jekk tkun meħtieġa aktar stimulazzjoni fl-ovarji, injezzjonijiet ta' mediċina oħra simili għal Elonva, iżda li tista' tingħata kuljum, jistgħu jingħataw.
English: In the first study in women weighing 60 kg or less, the number of eggs collected from each woman was 13.3 for those treated with Elonva and 10.6 for those treated with follitropin beta.
Maltese: Fl-ewwel studju tan-nisa li jiżnu 60 kg jew inqas, in-numru ta' bajd miġbur minn kull mara kien 13.3 għal dawk ikkurati b'Elonva u 10.6 għal dawk ikkurati b'follitropin beta.
English: In the second study in women weighing above 60 kg, the average number of eggs collected from each woman was 13.8 in those treated with Elonva compared with 12.6 in those treated with follitropin beta.
Maltese: Fit-tieni studju tan-nisa li jiżnu aktar minn 60 kg, in-numru medju ta' bajd miġbur minn kull mara kien 13.8 għal dawk ikkurati b'Elonva meta mqabbel ma' 12.6 għal dawk ikkurati b'follitropin beta.
English: They will then be fertilised in a laboratory and the resulting embryo is implanted in the womb.
Maltese: Dawn imbagħad jiġu fertilizzati f'laboratorju u lembrijun li jirriżulta jitqiegħed fl-utru.
English: For the full list of side effects of Elonva, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji ta' Elonva, ara l-fuljett ta' tagħrif.
English: How does Elonva work?
Maltese: Kif jintuża Elonva?
English: What is Elonvaand what is it used for?
Maltese: X'inhuma l-benefiċċji ta' Elonva li ħarġu mill-istudji?
English: Elonva is a hormonal medicine used in women who are undergoing fertility treatment to stimulate the development of more than one mature egg at a time in the ovaries.
Maltese: Elonva huwa mediċina ormonali li tintuża fuq nisa li għaddejjin minn kura tal-fertilità biex tistimula liżvilupp ta' aktar minn bajda waħda matura kull darba fl-ovarji.
English: What measures are being taken to ensure the safe and effective use of Elonva?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Elonva?
English: It is given once as a single injection under the skin in a dose of 100 or 150 micrograms, depending on age and body weight.
Maltese: Elonva jingħata darba bħala injezzjoni waħda taħt il-ġilda f'doża ta' 100 jew 150 mikrogramma, skont l-età u l-piż tal-ġisem.
English: Side effects reported with Elonva are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Elonva huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: 1138, Budapest
Maltese: 1138, Budapest Hungary
English: Kifissias Avenue 368, Halandri, 152 33 Greece
Maltese: Diophar SA Kifissias 368 Halandri 15233 Greece
English: Sweden Baxter Medical AB Box 63
Maltese: Baxter AB Box 63
English: Extraneal (Icodextrin 7.5%) Solution for peritoneal dialysis
Maltese: Extraneal (lcodextrin 7.5%) Solution for peritoneal dialysis
English: Poland Baxter Polska SP. z o.o.
Maltese: Baxter Polska SP. z.o.o.
English: Irland
Maltese: Ireland
English: County Mayo IRELAND
Maltese: County Mayo Irland
English: 7,5 % 75 g / 1000 ml
Maltese: 7,5 % 75 9 I 1000 ml
English: Netherlands Baxter B.V., Kobaltweg 49, 3542
Maltese: Baxter B.V Kobaltweg 49
English: Romania BAXTER HEALTHCARE S.A.
Maltese: Baxter Healthcare S.A.
English: w/v
Maltese: Extraneal w/v
English: Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeist of
Maltese: Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeis t of
English: Baxter Healthcare GmbH, Stella-KleinLöw-Weg 15, A-1020 Wien, Austria
Maltese: Baxter Healthcare GmbH Stella-Klein-Löw-Weg 15, A-1020
English: Baxter SPA piazzale dell' industria 2000144-roma Italy
Maltese: Piazzale dell'Industria 20 00144
English: Nutrineal PD4 mit 1,1 % AminosäurenPeritonealdialyselösung alanine 951 mg/L, arginine 1071 mg/L, glycine 510 mg/L, histidine 714 mg/L, isoleucine 850 mg/L, leucine 1020 mg/L, lysine hydrochloride 955 mg/L, methionine 850 mg/L, phenylalanine 570 mg/L, proline 595 mg/L, serine 510 mg/L, threonine 646 mg/L, tryptophan 270 mg/L, tyrosine 300 mg/L, valine 1393 mg/L, sodium chloride 5380 mg/L, calcium chloride dihydrate 184 mg/L, magnesium chloride hexahydrate 51 mg/L, sodium(s)-lactate 4480 mg/L
Maltese: Nutrineal PD4 mit 1,1 % AminosäurenPeritonealdialyselösung alanine 951 mg/L, arginine 1071 mg/L, glycine 510 mg/L, histidine 714 mg/L, isoleucine 850 mg/L, leucine 1020 mg/L, Iysine hydrochloride 955 mg/L, methionine 850 mg/L, phenylalanine 570 mg/L, proline 595 mg/L, serine 510 mg/L, threonine 646 mg/L, tryptophan 270 mg/L, tyrosine 300 mg/L, valine 1393 mg/L, sodium chloride 5380 mg/L, calcium chloride dihydrate 184 mg/L, magnesium chloride hexahydrate 51 mg/L, sodium(s)Iactate 4480 mg/L
English: 4 to 1,1% acides aminés
Maltese: 4 to 1,1% amino acids
English: Germany Baxter Deutschland GmbH
Maltese: Ġermanja Baxter Deutschland GmbH Edisonstr.
English: Hungary Baxter Hungary Kft. Népfürdő u. 22.
Maltese: Baxter Hungary Kft.
English: Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal
Maltese: Edificio 10 Sintra Business Park,
English: Baxter Oy Valimotie 15 A 00380 Helsinki Finland
Maltese: Valimotie 15A 00381 Helsinski Finland
English: Bd René Branquart 80, B-7860 Lessines Belgium
Maltese: Boulevard R. Branquart 80 7680 Lessines Belgium
English: Box 270 Valimotie 15A 00381 Helsinki,
Maltese: Baxter Oy P.O. Box 270 Valimotie 15A 00381 Helsinski Finland
English: Denmark Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark
Maltese: Danimarka Baxter A/S Gydevang 43
English: Castlebar
Maltese: Awstrija
English: Finland Baxter Healthcare S.A. Moneen Road,
Maltese: Finlandja Baxter Healthcare S.A. Moneen Road Castlebar, CO.
English: 78310 Maurepas France
Maltese: Avenue louis Pasteur 78310 ZA de Coigneres 78310 Maurepas France
English: Slovenia Baxter d.o.o., Zelezna cesta 18 , Ljubljana, SI-1000, Slovenia
Maltese: Baxter d.o.o., Zelezna cesta 18 ,Ljubljana, SI-1000, Slovenia
English: Sweden Baxter Healthare SA Moneen Road
Maltese: Baxter Healthare SA Moneen Road Castlebar
English: Norfolk IP24 3SE
Maltese: Thetford IP24
English: Caxton Way, Thetford, Norfolk, 1P24 3SE, Thetford,
Maltese: Thetford, Norfolk, IP24
English: Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland
Maltese: Baxter Healthcare SA Moneen Road Castlebar, County Mayo Ireland
English: Lithuania Baxter Oy, P.O.
Maltese: Finlandja Baxter Oy P.O. Box 270
English: 11,205 g / l 5.38 g / l 0.184 g / l
Maltese: 11.205 g/l 5.38 g/l 0.184 g/l 0.0508 g/l 4.48 g/l
English: Romania BAXTER HEALTHCARE Ltd.,
Maltese: Rumanija Baxter Healthcare Ltd Caxton Way,
English: Dianeal PD1 Glucose 1.36% w/v
Maltese: Dianeal PDl Glucose 1.36% w/v
English: Dianeal PD1 Glucose 2.27% w/v
Maltese: Dianeal PDl Glucose 2.27% w/v
English: 13.60 g/l glucose anhydrate
Maltese: 13.60 g/l glucose anhydrous
English: D-85716
Maltese: D-85716 Unterschleißheim Germany
English: Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeist of
Maltese: Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis t of
English: Baxter Healthcare Ltd.,
Maltese: Baxter Healthcare Ltd Caxton Way,
English: Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeist of
Maltese: Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeist of
Maltese: Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeist of
Maltese: Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeist of
Maltese: Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis t of
English: Greece
Maltese: Islanda
English: Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeist of
Maltese: Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD1 Glucose 3.86% w/v
Maltese: Dianeal PDl Glucose 3.86% w/v
English: Lithuania Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland
Maltese: Rumanija Baxter Healthcare SA, Moneen Road, Castlebar, Co.
English: Anhydrous glucose 38.6 g/L, sodium chloride 5.67 g/L, sodium lactate 3.92 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L
Maltese: Anhydrous glucose 38.6 g/L, sodium chloride 5.67 g/L, sodium-L (+) lactate 3.92 g/L, calcium chloride dihydrate 0,257 g/L, Magnesium chloride hexahydrate 0,152 g/L
English: Norway
Maltese: Oslo, Norway
English: Moneen Road,
Maltese: Zona Industrial da Abrunheira,
English: 22,7g+5,38g+4,48g+0,184g+0,051g/l Solution for peritoneal dialysis
Maltese: Dianeal PD4 Glucose 22,7g+5,38g+4,48g+0,184g+0,051 g/l
English: Bulgaria BAXTER d.o.o.,Zelezna cesta 18, 1000
Maltese: BAXTER d.o.o.,Zelezna cesta 18, 1000 Ljubljana, Slovenia
English: Ljubljana,
Maltese: Norfolk,
English: Baxter AS Gjerdrumsvei 11 0484 Oslo, Norway
Maltese: Norveġja Baxter AS Gjerdrumsvei 11
English: 38,6g+5,38g+4,48g+0,184g+0,051g/l Solution for peritoneal dialysis
Maltese: Dianeal PD4 Glucose 38,6g+5,38g+4,48g+0,184g+0,051 g/l
English: Zelezna cesta 14, SI1000 Ljubljana, Slovenia
Maltese: Rumanija BAXTER d.o.o. Zelezna cesta 14, SI-1000 Ljubljana, Slovenia
English: 13,6g+5,38g+4,48g+0,184g+0,051g/l Solution for peritoneal dialysis
Maltese: Dianeal PD4 Glucose 13,6g+5,38g+4,48g+0,184g+0,051 g/l
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Maltese: Anness I Lista tal-ismijiet, għamla farmaċewtika, qawwiet tal-prodotti mediċinali, mnejn jingħata, applikanti / detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-istati membri
English: The full EPAR for Aptivus 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: • rifampicin (użata għall-kura tat-tuberkulożi);
English: It is available as capsules (250 mg) and as an oral solution.
Maltese: Jiġi bħala kapsuli (250 mg) u bħala soluzzjoni orali.
English: Other information about Aptivus:
Maltese: Informazzjoni oħra dwar Aptivus:
English: In the study of children and adolescents, 31% of the adolescents taking the capsules (9 out of 29) and 50% of the children taking the oral solution (31 out of 62) had reached and maintained viral loads below 400 copies/ml after 48 weeks.
Maltese: Fl-istudju fuq it-tfal u l-adolexxenti, 31% tal-adolexxenti li ħadu l-kapsuli (9 minn 29) u 50% tat-tfal li ħadu s-soluzzjoni orali (31 minn 62) kisbu u żammew tagħbiji virali inqas minn 400 kopja/ml wara 48 ġimgħa.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aptivus on 25 October 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Aptivus fil-25 ta' Ottubru 2005.
English: The active substance in Aptivus, tipranavir, is a protease inhibitor.
Maltese: Is-sustanza attiva f'Aptivus, it-tipranavir, hija inibitur tal-proteażi.
English: This document is a summary of the European public assessment report (EPAR) for Aptivus.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Aptivus.
English: Similar side effects were seen in children and adolescents, although vomiting, rash and pyrexia (fever) were seen more commonly than in adults.
Maltese: Effetti sekondarji simili dehru fit-tfal u fladolexxenti, minkejja li remettar, raxx u piressija (deni) dehru iktar frekwenti milli fl-adulti.
English: Aptivus is a medicine that contains the active substance tipranavir.
Maltese: Aptivus huwa mediċina li fiha s-sustanza attiva tipranavir.
English: Aptivus is used to treat patients aged two years and above who have human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Aptius jintuża fil-kura ta' pazjenti mill-età ta' sentejn jew aktar li għandhom il-virus talimmunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindromu mill-immunodefiċjenza akkwiżita (AIDS).
English: • St John's wort (a herbal preparation used to treat depression);
Maltese: • fexfiex tar-raba' (St John's wort) (preparazzjoni tal-ħxejjex użata għall-kura tad-depressjoni);
English: Aptivus has also been studied in one study involving 63 children aged between two and 12 years, and 52 adolescents aged between 12 and 18 years, almost all of whom had taken HIV treatments in the past.
Maltese: Aptivus ġie studjat ukoll fi studju wieħed li kien jinvolvi 63 tifel u tifla f'età bejn sentejn u 12-il sena, u 52 adolexxenti f'età bejn 12 u 18-il sena, li kważi kollha kemm huma fil-passat kienu ħadu kura kontra l-HIV.
English: In the two adult studies taken together, 34% of the patients taking Aptivus (251 out of 746) responded to treatment, compared with 16% of the patients taking the comparator protease inhibitors (113 out of 737).
Maltese: Fiż-żewġ studji fuq l-adulti meqjusa flimkien, 34% tal-pazjenti li ħadu Aptivus (251 minn 746) irrispondew għall-kura, meta mqabbla ma' 16% tal-pazjenti li ħadu l-inibituri tal-proteażi tat-tqabbil (113 minn 737).