FrancophonIA/ELRC3.0 huggingface dataset:
English: For pancreatic neuroendocrine tumours the figures were 11.4 months in the Sutent group and 5.5 months in the placebo group.
Maltese: Inkwantu ttumuri newroendokrinali pankreatiki, iċ-ċifri kienu 11.4 xhur fil-grupp ta' Sutent apparagun ma' 5.5 xhur fil-grupp tal-plaċebo.
English: • pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas) that have spread or cannot be removed with surgery.
Maltese: • tumuri newroendokrinali pankreatiki (tumuri taċ-ċelloli li jipproduċu l-ormoni fil-frixa) li jkunu nfirxu jew li ma jkunux jistgħu jitneħħew b'intervent kirurġiku.
English: Sutent was compared with placebo (a dummy treatment) in 312 patients with GIST whose previous treatment with imatinib had failed and in 171 patients with worsening pancreatic neuroendocrine tumours that could not be removed with surgery.
Maltese: Sutent tqabbel ma' plaċebo (trattament finta) f'312-il pazjent bil-GST li t-trattament preċedenti li kienu ngħataw bl-imatinib kien falla, u f'171 pazjent b'tumuri newroendokrinali pankreatiki li kienu qed jiggravaw u li ma setgħux jitneħħew b'intervent kirurġiku.
English: Sutent was also compared with another cancer medicine, interferon alfa, in 750 patients with metastatic renal cell carcinoma whose cancer had not been treated before.
Maltese: Sutent tqabbel ukoll ma' mediċina tal-kanċer oħra, l-interferon alfa, f'750 pazjent bil-karċinoma metastatika f'ċelloli renali li qatt ma kienu ngħataw kura għall-kanċer tagħhom.
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Sutent on 19 July 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni kkundizzjonata għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Sutent fid-19 ta' Lulju 2006.
English: A risk management plan has been developed to ensure that Sutent is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jassigura li Sutent jintuża bl-aktar mod sigur possibbli.
English: The dose can be adjusted according to the patient's response to the treatment, but should be kept within the range of 25 to 75 mg. For pancreatic neuroendocrine tumours, Sutent is given at a dose of 37.5 mg once a day without a rest period.
Maltese: Id-doża tista' tiżdied jew titnaqqas skont ir-reazzjoni tal-pazjent għat-trattament, iżda għandha dejjem tinżamm fil-limitu bejn 25 u 75 mg.
English: • gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel where there is uncontrolled growth of cells in the supporting tissues of these organs.
Maltese: • tumur stromali gastrointestinali (GIST), tip ta' kanċer fl-istonku u fil-musrana, ikkawżat minn tikbir bla rażan ta' ċelloli fit-tessuti li jsostnu dawn l-organi.
English: Why has Sutent been approved?
Maltese: Għaliex ġie approvat Sutent?
English: How has Sutent been studied?
Maltese: Kif ġie studjat Sutent?
English: Patients with GIST taking Sutent lived for an average of 26.6 weeks without the disease getting worse, compared with 6.4 weeks in the patients taking placebo.
Maltese: Il-pazjenti bil-GST li ngħataw kura b'Sutent għexu tul medja ta' 26.6 ġimgħat mingħajr ma ggravatilhom il-marda, apparagun mas-6.4 ġimgħat fil-pazjenti li kienu ngħataw il-plaċebo.
English: What is the risk associated with Sutent?
Maltese: X'inhu r-riskju assoċjat ma' Sutent?
English: • metastatic renal cell carcinoma, a type of kidney cancer, that has spread to other parts of the body;
Maltese: • karċinoma metastatika f'ċelloli renali, tip ta' kanċer fil-kliewi, li jkun infirex f'partijiet oħra talġisem;
English: For GIST and metastatic renal cell carcinoma, Sutent is given in six-week cycles, at a dose of 50 mg once a day for four weeks, followed by a two-week ‘rest period'.
Maltese: Għall-GIST u għall-karċinoma metastatika f'ċelloli renali, Sutent jingħata f'ċikli ta' sitt ġimgħat, b'doża ta' 50 mg darba kuljum tul erba' ġimgħat, segwiti b'ġimgħatejn ‘pawża'.
English: What measures are being taken to ensure the safe and effective use of Sutent?
Maltese: X'miżuri qegħdin jittieħdu biex jassiguraw użu sigur u effettiv ta' Sutent?
English: For the full list of all side effects and restrictions with Sutent, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Sutent, ara l-fuljett ta' tagħrif.
English: (Invented) name Strength Pharmaceutical Form
Maltese: Qawwa Għamla Farmaċewtika
English: 100 μg/dose
Maltese: 100 µg/doża
English: 83607 Holzkirchen Germany
Maltese: HEXAL AG, Industriestr. 25, 83607 Holzkirchen
English: The marketing applications were submitted as hybrid applications under Article 10(3) of Directive 2001/83/EC and the EU reference product is Sultanol Dosier-Aerosol 100 μg/dose, Druckgasinhalation, suspension, (GlaxoSmithKline).
Maltese: L-applikazzjonijiet għat-tqegħid fis-suq ġew ippreżentati bħala applikazzjonijiet ibridi skont l-Artikolu 10(3) tad-Direttiva 2001/83/KE u l-prodott ta' referenza tal-UE huwa Sultanol Dosier-Aerosol 100 μg/doża, Druckgasinhalation, sospensjoni, (GlaxoSmithKline).
English: Sanohex is a metered dose aerosol inhaler containing a suspension formulation of salbutamol sulphate 100 µg/spray, with HFA 134a as propellant.
Maltese: Sanohex huwa inalatur aerosol ta' doża mkejla li fih formulazzjoni ta' sospensjoni ta' salbutamol sulfat 100 µg/sprej, b'HFA 134a bħala propellent.
English: - the CHMP considered that Sanohex and the reference product possess the same systemic safety profile, as demonstrated by the bioequivalence in systemic levels (AUC and Cmax),
Maltese: - is-CHMP ikkunsidra li Salbumalin u l-prodott ta' referenza għandhom l-istess profil ta' sigurtà sistemika minħabba li ntweriet il-bijoekwivalenza f'livelli sistemiċi (AUC u Cmax),
English: Avenue louis Pasteur ZA de Coignières Maurepas 78310 Maurepas France
Maltese: Avenue louis Pasteur 78310 ZA de Coignieres 78310 Maurepas Franza
English: Baxter MédicoFarmacêutica, Lda.
Maltese: Baxter Médico Farmacêutica Lda
English: Kruczkowskiego 8 st., 00-380 Warszawa Poland
Maltese: Kruczkowskiego 8 st., 00-380
English: D-85716 Unterschleißheim Germany
Maltese: D-85716 Unterschleißheim Il-Ġermanja
English: 3.36, Potassium Chloride Ph. Eur.
Maltese: Ph. Eur. 3.36, Potassium Chloride Ph. Eur.
English: Germany Baxter Deutschland GmbH Edisonstr.
Maltese: Il-Ġermanja Baxter Deutschland GmbH Edisonstr.
English: Sweden Baxter Medical AB Box 63
Maltese: L-Iżvezja Baxter Medical AB Box 63
English: Pouet de Camilo 2 Ribarroja del Turia (Valencia)
Maltese: Ribarroja del Turia (Valencia)
English: Sodium Hydroxide 52.25 g Water for Injections to 100 ml
Maltese: Lactic Acid 139 g Sodium Hydroxide 52.25 g Water for Injections to 100 ml
English: Baxter SPA piazzale dell' industria 20 - 00144 Roma, Italy
Maltese: Piazzale dell'Industria 20 00144
English: Baxter Oy Valimotie 15 A 00381 Helsinki Finland
Maltese: Valimotie 15A 00381 Helsinki Il-Finlandja
English: Belgium Baxter SA Boulevard R. Branquart 80 7680 Lessines Belgium
Maltese: Il-Belġju Baxter S.A. Boulevard R. Branquart 80 7680 Lessines Il-Belġju
English: Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeistof
Maltese: Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeis t of
English: Baxter Polska SP. z o.o.
Maltese: Il-Polonja Baxter Polska SP. z.o.o.
English: Glucose Monohydrate Ph. Eur.1.1, Sodium Chloride Ph. Eur.
Maltese: Glucose Monohydrate Ph. Eur.1.1, Sodium
English: Denmark Baxter A/S, Gydevang 43, DK-3450 Allerød
Maltese: Id-Danimarka Baxter A/S Gydevang 43
English: Natriumklorid Baxter 9 mg/ml solution for infusion intravenous use
Maltese: Natriumklorid Baxter 9 mg/ml
English: IP24 3SE
Maltese: IP24
English: 75.00 g/l Icodextrine
Maltese: 75.00 g/l Icodextrin
English: Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien Austria
Maltese: L-Awstrija Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020
English: Luxembourg Baxter SA, Bd René Branquart 80, B-7860 Lessines Belgium
Maltese: Bd René Branquart 80 B-7860 Lessines Il-Belġju
English: Extraneal (Icodextrin 7.5%) Solution for peritoneal dialysis icodextrin 75g/l; sodium chloride 5.4g/l; calcium chloride 0,257g/l; magnesium chloride 0.051g/l; sodium s-lactate 4.5g/l
Maltese: Extraneal (lcodextrin 7.5%) Solution for peritoneal dialysis icodextrin 75g/l; sodium chloride 5.4g/l; calcium chloride 0,257g/l; magnesium chloride 0.051g/l; sodium s-lactate 4.5g/l
English: County Mayo Ireland
Maltese: Mayo, L-Irlanda
English: Netherlands Baxter B.V., Kobaltweg 49, 3542 CE Utrecht
Maltese: L-Olanda Baxter B.V Kobaltweg 49
English: 75 g/l icodextrine
Maltese: 75 g/l icodextrin
English: Eur., 0.257, Magnesium Chloride Hexahydrate Ph. Eur.0.152, Sodium Lactate Ph. Eur.
Maltese: Dihydrate Ph. Eur., 0.257, Magnesium Chloride Hexahydrate Ph. Eur.0.152, Sodium Lactate
English: 7,5 % 75 g / 1000 ml peritoneal use
Maltese: 7,5 % 75g/1000 ml
English: Hungary Baxter Hungary Kft. Népfürdő u. 22.
Maltese: L-Ungerija Baxter Hungary Kft.
English: Iceland Baxter Healthare SA Moneen Road
Maltese: L-Iżvezja Baxter Healthcare SA Moneen Road
English: L-Tyrosine 0.300 g/l L-Tryptophan 0.270 g/l L-Phenylalanine 0.570 g/l L-Threonine 0.646 g/l L-Serine 0.510 g/l
Maltese: L-Tyrosine Ph.Eur. 0.300 g, LTryptophan Ph.Eur. 0.270 g, LPhenylalanine Ph.Eur. 0.570 g, LThreonine Ph.Eur. 0.646 g, L-Serine Ph.Eur. 0.510 g, L-Proline Ph.Eur.
English: Slovenia Baxter d.o.o., Zelezna cesta 18 , Ljubljana, SI-1000, Slovenia
Maltese: Is-Slovenja Baxter d.o.o., Zelezna cesta 18 ,Ljubljana, SI-1000, IsSlovenja
English: Kifissias Avenue 368, Halandri, 152 33 Greece
Maltese: Halandri 15233
English: BAXTER d.o.o.,Zelezna cesta 18, 1000 Ljubljana Slovenia
Maltese: Il-Bulgarija BAXTER d.o.o.,Zelezna cesta 18, 1000 Ljubljana, Slovenja
English: Sodium Chloride 5.38 g/l Quantitative Composition of Sodium Lactate Lactic Acid 139 g
Maltese: Sodium Lactate 4.48 g/l Sodium Chloride 5.38 g/l Quantitative Composition of Sodium Lactate
English: Nutrineal PD4 with 1.1% Amino Acids tyrosine 0.03%w/v; tryptophan 0.027%w/v; phenylalanine 0.057%w/v; threonine 0.064%w/v; L-serine 0.051%w/v; L-proline 0.058%w/v; glycine 0.051%w/v; L-alanine 0.095%w/v; valine 0.139%w/v; methionine 0.085%w/v; isoleucine 0.085%w/v; leucine 0.102%w/v; lysine 0.095%w/v; histidine 0/071%w/v; arginine 0.107%w/v; calcium chloride 0.018%w/v; magnesium chloride 0.005%w/v; sodium chloride 0.538%w/v; sodium s-lactate 0.448%w/v
Maltese: L-proline 0.058%w/v; glycine 0.051%w/v; Lalanine 0.095%w/v; valine 0.139%w/v; methionine 0.085%w/v; isoleucine 0.085%w/v; leucine 0.102%w/v; lysine 0.095%w/v; histidine 0/071%w/v; arginine 0.107%w/v; calcium chloride 0.018%w/v; magnesium chloride 0.005%w/v; sodium chloride 0.538%w/v; sodium slactate 0.448%w/v
English: 22.7 g/l glucose anhydrate
Maltese: 22.7 g/l glucose anhydrous
English: Finland Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo
Maltese: Il-Finlandja Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo
English: Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE United Kingdom
Maltese: Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24
English: Baxter Healthcare Ltd., Caxton Way, Thetford,
Maltese: Baxter Healthcare Ltd Caxton Way,
English: Lithuania Baxter Oy, P.O.
Maltese: Il-Litwanja Baxter Oy P.O. Box 270
English: 38.6 g/l glucose anhydrate
Maltese: 38.6 g/l glucose anhydrous
English: 951 mg/l; 1071 mg/l; 510 mg/l; 714 mg/l; 850 mg/l; 1020 mg/l; 955 mg/l; 850 mg/l; 570 mg/l; 595 mg/l; 510 mg/l; 646 mg/l; 720 mg/l; 300 mg/l; 1393 mg/l; 5380 mg/l; 184 mg/l; 51 mg/l; 4480 mg/l
Maltese: 951 mg/l; 1071 mg/l; 510 mg/l; 714 mg/l; 850 mg/l; 1020 mg/l; 955 mg/l; 850 mg/l; 570 mg/l; 595 mg/l; 510 mg/l; 646 mg/l; 720 mg/l; 300 mg/l; 1393 mg/l; 5380 mg/l;
English: 13.6 g/l glucose anhydrate
Maltese: 13.6 g/l glucose anhydrous
English: 0.257, Magnesium Chloride Hexahydrate Ph. Eur.
Maltese: 0.257 g/l, Magnesium Chloride Hexahydrate
English: 6.43, Calcium Chloride Dihydrate Ph.
Maltese: Chloride 6.43 g/l, Calcium Chloride Dihydrate
English: Ireland Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE
Maltese: Ir-Renju Unit Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24
English: DIOPHAR S.A.
Maltese: Baxter S.A.
English: 1,1% acides aminés
Maltese: 1,1% amino acids
English: Dianeal PD4 Glucose 2.27% w/v /22.7mg/ml magnseium chloride 0.005%w/v; glucose 2.27%w/v; sodium lactate 0.45%w/v; calcium chloride 0.018%w/v; sodium chloride 0.54%w/v
Maltese: Dianeal PD4 Glucose 2.27% w/v /22.7mg/ml magnesium chloride 0.005%w/v; glucose 2.27%w/v; sodium lactate 0.45%w/v; calcium chloride 0.018%w/v; sodium chloride 0.54%w/v
English: Icodextrin (75 g/l), Sodium chloride (5.4 g/l), Calcium chloride (0.257 g/l), Magnesium chloride (0.051 g/l), Sodium lactate solution (4.5 g/l)
Maltese: Calcium chloride (0.257 g/l), Magnesium chloride (0.051 g/l), Sodium lactate solution (4.5 g/l)
English: 0.39 % w/v Calcium Chloride Ph.Eur.
Maltese: Sodium Lactate Ph.Eur. 0.39 % w/v Calcium Chloride Ph.Eur. 0.0257 % w/v
English: Dianeal PD1 Glucose 2.27% w/v /22.7mg/ml sodium chloride 0.57%w/v; glucose 2.27%w/v; magnesium chloride 0.015%w/v; sodium lactate 0.39%w/v; calcium chloride 0.026%w/v
Maltese: Dianeal PD1 Glucose 2.27% w/v /22.7mg/ml sodium chloride 0.57%w/v; glucose 2.27%w/v; magnesium chloride 0.015%w/v; sodium lactate 0.39%w/v; calcium chloride 0.
English: Strength
Maltese: Kista
English: Zona Industrial da Abrunheira - Edifício 10Sintra Business Park, 2710-089 Sintra Portugal
Maltese: 2710-089 Sintra Il-Portugall
English: Dianeal PD4 Glucose 1.36% w/v /13.6mg/ml magnseium chloride 0.005%w/v; glucose 1.36%w/v; sodium lactate 0.45%w/v; calcium chloride 0.018%w/v; sodium chloride 0.54%w/v
Maltese: Dianeal PD4 Glucose 1.36% w/v /13.6mg/ml magnesium chloride 0.005%w/v; glucose 1.36%w/v; sodium lactate 0.45%w/v; calcium chloride 0.018%w/v; sodium chloride 0.54%w/v
English: Dianeal PD4 Glucose 3.86% w/v /38.6mg/ml magnseium chloride 0.005%w/v; glucose 3.86%w/v; sodium lactate 0.45%w/v; calcium chloride 0.018%w/v; sodium chloride 0.54%w/v
Maltese: Dianeal PD4 Glucose 3.86% w/v /38.6mg/ml magnesium chloride 0.005%w/v; glucose 3.86%w/v; sodium lactate 0.45%w/v; calcium chloride 0.018%w/v; sodium chloride 0.54%w/v
English: L-Methionine 0.850 g/l L-Isoleucine 0.850 g/l L-Leucine 1.020 g/l L-Lysine (chlorhydrate) 0.955 g/l L-Histidine 0.714 g/l L-Arginine 1.071 g/l Calcium chloride dihydrate 0.184 g/l Magnesium chloride hexahydrate 0.051 g/l Sodium Lactate 4.48 g/l
Maltese: L-Tyrosine 0.300 g/l L-Tryptophan 0.270 g/l L-Phenylalanine 0.570 g/l L-Threonine 0.646 g/l L-Serine 0.510 g/l L-Proline 0.595 g/l Glycine 0.510 g/l L-Alanine 0.951 g/l L-Valine 1.393 g/l L-Methionine 0.850 g/l L-Isoleucine 0.850 g/l L-Leucine 1.020 g/l L-Lysine (chlorhydrate) 0.955 g/l L-Histidine 0.714 g/l L-Arginine 1.071 g/l Calcium chloride dihydrate 0.184 g/l
English: Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeistof
Maltese: Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeistof
Maltese: Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeistof
Maltese: Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis t of
English: Baxter AS Gjerdrumsvei 11 0484 Oslo Norway
Maltese: In-Norveġja Baxter AS Gjerdrumsvei 11
English: 3.86 % w/v or Glucose Monohydrate Ph.Eur.
Maltese: Anhydrous Glucose Ph.Eur. 3.86 % w/v or Glucose Monohydrate Ph.Eur. 4.25 % w/v
English: 22,7g+5,38g+4,48g+0,184g+0,051g/l
Maltese: Dianeal PD4 Glucose 22,7g+5,38g+4,48g+0,184g+0,051 g/l
English: Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeistof
Maltese: Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeistof
Maltese: Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeistof
Maltese: Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis t of
English: 3,86% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v
Maltese: 3,86% w/v 0,538% w/v 0,448% w/v
English: 1,36% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v
Maltese: 1,36% w/v 0,538% w/v 0,448% w/v
English: solution for dialysis peritoneal
Maltese: Solución para diálisis peritoneal
English: Calcium Chloride: 0.026% w/v. glucose 0.110%w/v; sodium lactate 0.336%w/v; sodium chloride 0.643%w/v; magnesium chloride 0.015%w/v solution for haemodialysis/hae mofiltration intraarterial use, intravenous use
Maltese: 0.110%w/v; sodium lactate 0.336%w/v; sodium chloride 0.643%w/v; magnesium chloride 0.015%w/v
English: Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland
Maltese: Il-Finlandja Baxter Healthcare S.A. Moneen Road Castlebar, CO. Mayo LIrlanda
English: 1.36 % w/v or Glucose Monohydrate Ph.Eur.
Maltese: Anhydrous Glucose Ph.Eur. 1.36 % w/v or Glucose Monohydrate Ph.Eur. 1.50 % w/v
English: 38,6g+5,38g+4,48g+0,184g+0,051g/l
Maltese: Dianeal PD4 Glucose 38,6g+5,38g+4,48g+0,184g+0,051 g/l
English: Baxter Healthcare SA Moneen Rd Castlebar, Co. Mayo Ireland
Maltese: Baxter Healthcare SA, Moneen Rd, Castlebar, Co.
English: 1.1 g / l 6.43 g / l 0.257 g / l 0.298 g / l 0.152 g / l 3.36 g / l solution for haemodialysis hemodialysis
Maltese: 1.1 g / l 6.43 g / l 0.257 g / l 0.298 g / l 0.152 g / l 3.36 g / l
English: 13,6g+5,38g+4,48g+0,184g+0,051g/l
Maltese: Dianeal PD4 Glucose 13,6g+5,38g+4,48g+0,184g+0,051 g/l
English: 1.1 g / l 6.43 g / l 0.257 g / l 0.149 g / l 0.152 g / l 3.36 g / l solution for haemodialysis hemodialysis
Maltese: 1.1 g / l 6.43 g / l 0.257 g / l 0.149 g / l 0.152 g / l 3.36 g / l
English: 6.43, Calcium Chloride Dihydrate Ph. Eur.
Maltese: Chloride Ph. Eur. 6.43, Calcium Chloride
English: Glucose monohydrate 1.1 g/L, sodium chloride 6.43 g/L, sodium lactate 3.36 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L, potassium chloride 0.298 g/L
Maltese: 6.43 g/L, sodium lactate 3.36 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L, potassium chloride 0.298 g/L
English: 0.448 % w/v Calcium Chloride Ph.Eur.
Maltese: Calcium Chloride Ph.Eur. 0.0184 % w/v
English: Estonia
Maltese: Wien
English: Glucose monohydrate 1.1 g/L, sodium chloride 6.43 g/L, sodium lactate 3.36 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L, potassium chloride 0.149 g/L
Maltese: 6.43 g/L, sodium lactate 3.36 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L, potassium chloride 0.149 g/L
English: Icodextrin 7.5 % w/v, Sodium Chloride Ph.
Maltese: Icodextrin (75 g/l), Sodium chloride (5.4 g/l),
English: Norfolk IP24 3SE United Kingdom
Maltese: Thetford, Norfolk, IP24
English: 0.538 % w/v Sodium Lactate Ph.Eur.
Maltese: Sodium Chloride Ph.Eur. 0.538 % w/v
English: Glucose monohydrate 1.1 g/L, sodium chloride 6.43 g/L, sodium lactate 3.36 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L
Maltese: 6.43 g/L, sodium lactate 3.36 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L
English: 0.54 % w/v, Sodium (S)-lactate 0.45 % w/v, Calcium Chloride Ph. Eur.
Maltese: sodium chloride 0.643%w/v; magnesium chloride 0.015%w/v; calcium chloride
English: 951 mg/l; 1071 mg/l; 510 mg/l; 714 mg/l; 850 mg/l; 1020 mg/l; 955 mg/l; 850 mg/l; 570 mg/l; 595 mg/l; 510 mg/l; 646 mg/l; 270 mg/l; 300 mg/l; 1393 mg/l; 5380 mg/l; 184 mg/l; 51 mg/l; 4480 mg/l
Maltese: 850 mg/l; 1020 mg/l; 955 mg/l; 850 mg/l; 570 mg/l; 595 mg/l; 510 mg/l; 646 mg/l;
English: 0.57 % w/v Sodium Lactate Ph.Eur.
Maltese: Sodium Chloride Ph.Eur. 0.57 % w/v
English: 1.1 g / l 6.43 g / l 0.257 g / l 0.152 g / l 3.36 g / l solution for haemodialysis hemodialysis
Maltese: 1.1 g / l 6.43 g / l 0.257 g / l 0.152 g / l 3.36 g / l
English: sodium chloride 0.643%w/v; magnesium chloride 0.015%w/v; calcium chloride 0.026%w/v; glucoae 0.110%w/v; potassium chloride 0.015%w/v; sodium lactate 0.336%w/v solution for haemodialysis/hae mofiltration intraarterial use, intravenous use
Maltese: 0.026%w/v; glucoae 0.110%w/v; potassium chloride 0.015%w/v; sodium lactate 0.
English: 1,36 % w/v / 13,6 mg/ml peritoneal use
Maltese: 1,36% w/v/13,6 mg/ml
English: Nutrineal PD4 mit 1,1 % Aminosäuren
Maltese: Nutrineal PD4 mit 1,1 % Aminosauren
English: Zelezna cesta 14, SI-1000 Ljubljana
Maltese: Ir-Rumanija BAXTER d.o.o. Zelezna cesta 14, SI-1000 Ljubljana, Is-Slovenja
English: Denmark
Maltese: Sverige
English: 0.0257 % w/v Magnesium Chloride Ph.Eur.
Maltese: Magnesium Chloride Ph.Eur. 0.0152 % w/v
English: Nutrineal PD4+A.A.1,1% 1,1% amino acids
Maltese: Nutrineal PD4+A.A.1,1
English: 0.0051 % w/v
Maltese: L-serine 0.051%w/v;
English: The
Maltese: Is-sistema
English: The application was withdrawn after ‘day 180'.
Maltese: L-applikazzjoni ġiet irtirata wara ‘jum 180'.
English: 16 February 2012
Maltese: 16 ta' Frar 2012
English: Withdrawal of the marketing authorisation application for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted) EMA/CHMP/114709/2012
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Fluad Paediatric (vaċċin tal-influwenza, antiġenu tal-wiċċ, inattivat, imsaħħaħ) EMA/CHMP/114709/2012
English: What is Fluad Paediatric?
Maltese: X'inhu Fluad Paediatric?
English: The applicant presented data on experimental models from similar vaccines.
Maltese: L-applikant ippreżenta dejta dwar mudelli sperimentali minn vaċċini simili.
English: Fluad Paediatric contains proteins from three influenza virus strains.
Maltese: Fluad Paediatric fih proteini minn tliet razez ta' virus tal-influwenza.
English: The company also presented results of studies in humans, including one main study in 4,902 children.
Maltese: Il-kumpanija ppreżentat ukoll ir-riżultati ta' studji fil-bniedem, inkluż studju ewlieni f'4,902 itfal.
English: Fluad Paediatric is a vaccine to protect against seasonal influenza.
Maltese: Fluad Paediatric huwa vaċċin li jipproteġi kontra l-influwenza staġjonali.
English: The children were given either Fluad Paediatric, another influenza vaccine (Agrippal or Influsplit) or a non-influenza vaccine (Menjugate or Encepur).
Maltese: It-tfal ingħataw jew Fluad Paediatric, jew vaċċin tal-influwenza ieħor (Agrippal jew Influsplit) jew vaċċin mhux tal-influwenza (Menjugate jew Encepur).
English: On 10 February 2012, Novartis Vaccines and Diagnostics officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Fluad Paediatric, for the prevention of seasonal influenza in infants and children.
Maltese: Fl-10 ta' Frar 2012, Novartis Vaccines and Diagnostics għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni tagħha li tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Fluad Paediatric, għall-prevenzjoni tal-influwenza staġjonali fit-trabi u fit-tfal.
English: Withdrawal of the marketing authorisation application for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Fluad Paediatric (vaċċin talinfluwenza, antiġenu tal-wiċċ, inattivat, imsaħħaħ)
English: When a person is given the vaccine, the immune system recognises the viral parts as ‘foreign' and makes antibodies against them.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immunitarja tagħraf il-partijiet virali bħala ‘barranin' u toħloq antikorpi kontrihom.
English: It contains proteins from three inactivated influenza (flu) virus strains.
Maltese: Fih proteini minn tliet razez ta' virusijiet tal-influwenza inattivati.
English: Fluad Paediatric was expected to be used to prevent influenza in infants and children aged from six months to less than nine years.
Maltese: Fluad Paediatric kien mistenni li jintuża għall-prevenzjoni tal-influwenza fit-trabi u fit-tfal minn sitt xhur sa inqas minn disa' snin.
English: How is Fluad Paediatric expected to work?
Maltese: Kif huwa mistenni li jaħdem Fluad Paediatric?