FrancophonIA/ELRC3.0 huggingface dataset:
English: The justification of the applicant was based on 6 ‘non-published' studies, 5 full and one published by abstract only, which have been provided in support of the application (BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 and BY1023/VMG309).
Maltese: Il-ġustifikazzjoni tal-applikant kienet ibbażata fuq 6 studji ‘mhux ippubblikati', 5 sħaħ u wieħed ippubblikat b'astratt biss, li ġew ipprovduti b'appoġġ għall-applikazzjoni (BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 u BY1023/VMG309).
English: ITT
Maltese: JIS
English: Pan 20, 40, Niz 150 bid weeks
Maltese: Pan 20, 40, Niz 150 bid ġimgħat
English: The applicant, in addition to study BGI022 (CSR 257/2004), referred to study MEX020 (CSR 200/2004).
Maltese: Minbarra l-istudju BGI022 (CSR 257/2004), l-applikant irrefera għall-istudju MEX020 (CSR 200/2004).
English: the CHMP concluded that the studies BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 and BY1023/VMG309 submitted by the applicant for which the claim of one year data exclusivity is sought, were not relevant and necessary to the classification of CONTROLOC Control 20 mg gastro-resistant tablets as ‘medicinal product not subject to medical prescription'.
Maltese: Is-CHMP ikkonkluda li l-istudji BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 u BY1023/VMG309 ippreżentati mill-applikant li għalihom qiegħda tintalab is-sena esklussività tal-informazzjoni, ma kinux rilevanti u meħtieġa għallklassifikazzjoni ta' CONTROLOC Control 20 mg pilloli gastro-reżistenti bħala ‘prodott mediċinali li ma jingħatax b'riċetta tat-tabib'.
English: n
Maltese: A.
English: Relief of symptoms in GORD Stage A-D
Maltese: Serħan mis-sintomi flIstadju A-D tal-GORD
English: Nycomed GmbH, D-78467 Konstanz
Maltese: Byk-Gulden-Straße 2, 78467 Konstanz Il-Ġermanja
English: The gastro-resistant coating consists of methacrylic acid - ethyl acrylate copolymer 1:1; triethyl citrate is added as a plasticizer.
Maltese: Methacrylic acid-ethyl acrylate copolymer (1:1) Sodium laurilsulfate
English: GCP
Maltese: PSUR
English: Endoscopic healing of GORD Stage II/III after 4 and 8 weeks of treatment
Maltese: Fejqan endoskopiku tal-Istadju I talGORD I/III wara 4 u 8 ġimgħat ta' trattament
English: Relief of typical GORD symptoms
Maltese: Serħan mis-sintomi tipiċi tal-GORD
English: Pantozol 20 mg gastro-resistant tablets
Maltese: CONTROLOC Control 20 mg pilloli gastro-reżistenti
English: 4 weeks
Maltese: 3 snin
English: The study concluded that pantoprazole 20 mg has a trend to have a faster relief of symptoms during the first 7 days of treatment compared with omeprazole 10 mg, but no statistically significant differences were found after 7 days, 4 weeks or 8 weeks treatment between the groups.
Maltese: L-istudju kkonkluda li pantoprazole 20 mg għandu tendenza li jipprovdi serħan aktar malajr tas-sintomi matul l-ewwel 7 ijiem ta' trattament meta mqabbel ma' omeprazole 10 mg, iżda ma nstabet ebda differenza statistikament sinifikanti wara 7 ijiem, 4 ġimgħat jew 8 ġimgħat ta' trattament bejn il-gruppi.
English: Enrolment
Maltese: Assorbiment
English: Pharmacokinetics
Maltese: FARMAĊEWTIKU
English: The applicant also referred to studies BF010 (CSR 298E/99) and VMG309 (CSR 323/2004) which were considered to provide data for early onset of relief of reflux symptoms.
Maltese: L-applikant irrefera wkoll għall-istudji BF010 (CSR 298E/99) u VMG309 (CSR 323/2004) li kienu kkunsidrati li jipprovdu dejta għall-bidu kmieni tas-solljiev mis-sintomi ta' rifluss.
English: Pantoprazole was superior to placebo
Maltese: Pantoprazole kien superjuri għal plaċebo
English: The usual starting dose for omeprazole in reflux disease is 20 mg; 10 mg omeprazole is not therapeutically equivalent to 20 mg pantoprazole.
Maltese: Id-doża normali tal-bidu għal omeprazole f'marda ta' rifluss hija 20 mg; 10 mg omeprazole mhijiex terapewtikament ekwivalenti għal 20 mg pantoprazole.
English: Detailed description of the Pharmacovigilance system
Maltese: Sistema ta' farmakoviġilanza
English: 346 Pantoprazole and omeprazole
Maltese: 346 Pantoprazole u omeprazole kienu effikaċi b'mod simili
English: Results
Maltese: EFFETTI
English: Symptom relief at 2 and 4 weeks of treatment
Maltese: 2 u 4 ġimgħat ta' trattament
English: The CHMP reviewed the clinical data submitted, taking into account the provisions of Article 74a of Directive 2001/83/EC, as amended, in support of the classification of CONTROLOC Control 20 mg gastro-resistant tablets as ‘medicinal product not subject to medical prescription'.
Maltese: Is-CHMP ivvaluta l-informazzjoni ppreżentata, billi kkunsidra d-dispożizzjonijiet tal-Artikolu 74a tadDirettiva 2001/83/KE, kif emendata, b'appoġġ għall-klassifikazzjoni ta' CONTROLOC Control 20 mg pilloli gastro-reżistenti bħala ‘prodott mediċinali li ma jingħatax b'riċetta tat-tabib'.
English: The excipients used in the formulation of the finished product are well known excipients used for preparation of tablets such as sodium carbonate, mannitol, crospovidone, povidone K90, calcium stearate (present in tablet core), hypromellose, povidone K25, titanium dioxide, yellow iron oxide, methacrylic acid-ethyl acrylate copolymer (1:1), sodium laurilsulfate, polysorbate 80, triethyl citrate (present in film-coating, including enteric coating and undercoating), shellac, red iron oxide, black iron oxide, yellow iron oxide, soya lecithin, titanium dioxide and antifoam DC 1510 (present in printing ink).
Maltese: Kisja: hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer, sodium lauril sulfate, polysorbate 80, triethyl citrate.
English: • the safety profile of pantoprazole is well established and acceptable.
Maltese: • il-profil ta' sigurtà ta' pantoprazole huwa stabbilit tajjeb u aċċettabbli.
English: Open-label, multicenter
Maltese: INFORMAZZJONI BIL-BRAILLE
English: Similar results were shown in the published study M3-316 which compared the efficacy of 20 and 40 mg pantoprazole in the treatment of GORD symptoms.
Maltese: Intwerew riżultati simili fl-istudju ppubblikat M3-316 li qabbel l-effikaċja ta' 20 u 40 mg pantoprazole fit-trattament ta' sintomi GORD.
English: CH2
Maltese: Treddigħ
English: Pantoprazole: Lansoprazole:
Maltese: pantoprazole).
English: Each gastro-resistant tablet contains 20 mg pantoprazole (equivalent of 22.6 mg of pantoprazole sodium sesquihydrate).
Maltese: Kull pillola gastro-reżistenti fiha 20 mg ta' pantoprazole (bħala sodium sesquihydrate).
English: Pan 20, 40 4 weeks
Maltese: Pan 20, 40 4 ġimgħat
English: Pantozol 40 mg gastro-resistant tablets
Maltese: 14-il pillola gastro-reżistenti
English: Pantoprazole was superior to ranitidine
Maltese: Pantoprazole kien superjuri għal ranitidine
English: Pantoprazole was superior to ranitidine in the treatment of key GORD symptoms.
Maltese: Pantoprazole kien superjuri għal ranitidine fit-trattament ta' sintomi prinċipali GORD.
English: Pantoprazole inhibits the gastric H+/K+-ATPase (the proton pump) and thereby inhibits H+ ion transfer into the gastric lumen.
Maltese: jkollok bżonn ta' testijiet tad-demm addizzjonali - atazanavir (jintuża għal kura ta' infezzjoni bl-HIV).
English: Tablets are yellow, oval, biconvex, film-coated and imprinted with “P20” in brown ink on one side.
Maltese: Pilloli miksija b'rita, sofor, ovali u bikonvessi stampati b'“P20” b'linka kannella fuq naħa waħda.
English: The PSUR submission schedule for CONTROLOC Control 20 mg gastro-resistant tablets should follow the PSUR submission schedule of the reference medicinal product.
Maltese: L-iskeda ta' sottomissjoni tal-PSUR għal CONTROLOC Control 20 mg pilloli gastro-reżistenti għandha ssegwi l-iskeda ta' sottomissjoni tal-PSUR tal-prodott mediċinali ta' referenza.
English: Endoscopic healing of GORD Stage II/III
Maltese: Fejqan endoskopiku tal-Istadju I tal-GORD wara 4 ġimgħat
English: Diarrhoea Headache Nausea / Vomiting Abdominal distension and bloating Abdominal pain and discomfort Constipation Dizziness Liver enzymes increased (transaminases, γ-GT) Rash / Exanthema / Eruption Pruritus Sleep disorders Dry mouth Asthenia, fatigue and malaise Hyperlipidaemias and lipid increases Disturbances in vision / Blurred vision Hypersensitivity (incl.
Maltese: - Frekwenza mhux magħrufa: alluċinazzjoni, konfużjoni (speċjalment f'pazjenti bi storja medika ta' dawn is-sintomi); tnaqqis fil-livell ta' sodium fid-demm.
English: Duration Diagnosis Incl.
Maltese: dijarea infettiva.
English: Tablets are packed in Alu/Alu blisters without cardboard reinforcement or Alu/Alu blisters with cardboard reinforcement (blister wallet).
Maltese: CONTROLOC Control hu disponibbli f'folji Alu/Alu bi jew mingħajr cardboard reinforcement.
English: GORD symptoms with heartburn No oesophagitis at endoscopy
Maltese: Serħan mis-sintomi ewlenin tal-GORD u sintomi oħra tal-GI
English: 2.4 Clinical aspects
Maltese: 4.3 Kontra-indikazzjonijiet
English: Na+
Maltese: Ħakk
English: This study compared the efficacy and tolerability of pantoprazole 20 mg, 40 mg, or 80 mg in healing of oesophagitis and freedom from GORD symptoms.
Maltese: Dan l-istudju qabbel l-effikaċja u t-tollerabilità ta' pantoprazole 20 mg, 40 mg, jew 80 mg filfejqan tal-esofaġite u l-ħelsien mis-sintomi ta' GORD.
English: Placebo
Maltese: FOLJI
English: Numbers analysed
Maltese: U KWANTITATTIVA
English: Comparator
Maltese: Iponatrimija
English: Published studies showed noninferiority of pantoprazole compared to other PPIs (Study VMG305 and M3
Maltese: L-istudji ppubblikati wrew nuqqas ta' inferjorità ta' pantoprazole meta mqabbel ma' PPIs oħra (Studju VMG305 u M3
English: It is extensively metabolised in the liver.
Maltese: Żieda fittemperatura talġisem;
English: WA300
Maltese: Povidone K90
English: • pantoprazole 20mg is effective in the short-term treatment of GORD symptoms
Maltese: • pantoprazole 20mg huwa effikaċi fit-trattament fuq żmien qasir tas-sintomi tal-GORD
English: Randomisation
Maltese: Anġjoedema
English: This was considered acceptable.
Maltese: DATA TA' META ĠIET RIVEDUTA
English: Tablet and i.v.
Maltese: - Żomm dan il-fuljett.
English: 2.6 Legal Status
Maltese: .2 Inkompatibilitajiet
English: Pan 20, Placebo
Maltese: Pan 20, Plaċebo ġimagħtejn 219
English: Endoscopic healing of GORD Stage I after 8 weeks of treatment
Maltese: Fejqan endoskopiku tal-Istadju I talGORD wara 8 ġimgħat ta' trattament
English: Relief of symptoms in GORD Stage 0/I after 4 weeks of treatment
Maltese: Serħan mis-sintomi flIstadju 0/I talGORD wara 4 ġimgħat ta' trattament
English: OCF2H
Maltese: TAGĦRIF
English: CONTROLOC Control is presented in form of gastro-resistant tablets containing pantoprazole as an active substance.
Maltese: X'fih CONTROLOC Control - Is-sustanza attiva hi pantoprazole.
English: In this pivotal study the differences between pantoprazole 20 mg and ranitidine 150 mg results were significant; however the unpublished study conclusion for BGI022 were very similar to those of the published ranitidine 150 mg comparative study VMG306 and overall does not add significant value to the application.
Maltese: F'dan l-istudju pivotali, id-differenzi bejn ir-riżultati ta' pantoprazole 20 mg u ta' ranitidine 150 mg kienu sinifikanti; madankollu l-konklużjoni tal-istudju mhux ippubblikat għal BGI022 kienu simili ħafna għal dawk tal-istudju komparattiv ippubblikat dwar ranitidine 150 mg VMG306 u b'mod ġenerali ma żżidx valur sinifikanti għall-applikazzjoni.
English: Comparison of clinical safety and efficacy of 20mg, 40mg pantoprazole QD and nizatidine 150mg BID in symptomatic erosive oesophagitis
Maltese: CONTROLOC Control 20 mg pilloli gastro-reżistenti m'għandhomx jintmagħdu jew jitkissru, u għandhom jinbelgħu sħaħ mal-likwidu qabel l-ikel.
English: Pan 20, Ran 300 once daily
Maltese: Pan 20, Ran 300 darba kuljum
English: Pantoprazole: Esomeprazole:
Maltese: Pantoprazole kien ferm aktar effikaċi nizatidine
English: Disorientation (and all aggravations)
Maltese: Diżorjentament (u l-aggravamenti kollha)
English: Relief of key symptoms in GORD after 14 days
Maltese: Serħan mis-sintomi relatati mal-GORD wara 14-il jum u 28 jum
English: The following storage conditions and duration have been applied during the studies: 25 °C / 60% RH up to 60 months, 30 °C / 70% RH up to 36 months, 37 °C / 75% RH up to 20 months and 0 °C / 75% RH up to 6 months.
Maltese: 4%, wara 14-il jum bejn 67.7% u 90.4%, u wara 28 jum bejn 75.2% u 94.5%, rispettivament.
English: Relief of heartburn in GORD Stage 0/I at day 14
Maltese: Serħan millħruq tal-istonku fl-Istadju 0/I tal-GORD filjum 14
English: Published studies showed noninferiority of treatment were similarly effective pantoprazole compared to other PPIs (Study VMG305 and M3
Maltese: L-istudji ppubblikati jissuġġerixxu nuqqas ta' inferjorità ta' pantoprazole meta mqabbel ma' PPIs oħra (Studju VMG305 u M3
English: Ranitidine 150 mg bid Relief Rate of Acid Eructation (N/Total N)
Maltese: Fi studji fuq l-annimali (firien) 5 mg/kg kien l-NOAEL (No Observed Adverse Effect Level) osservat għall-embrijotossiċità.
English: formulations of pantoprazole have equipotent effect on intragastric pH.
Maltese: Pantoprazole hu kważi metabolizzat esklussivament fil-fwied.
English: Endoscopic healing of GORD Stage I
Maltese: Fejqan endoskopiku tal-Istadju I tal-GORD
English: Thrombocytopenia very rare
Maltese: Żieda filbilirubina
English: Day 14
Maltese: Tabella 1.
English: All demographic and baseline variables were described by statistical characteristics.
Maltese: Sindrome ta' Lyell; Eritema multiforme;
English: Clinical safety
Maltese: KLINIKU
English: Risks
Maltese: Kummenti
English: Study BY1023/BGI022 was particularly emphasised.
Maltese: Saret enfasi partikolari fuq l-istudju BY1023/BGI022.
English: 344 Pantoprazole was superior to ranitidine in the relief of GORD symptoms
Maltese: 344 Pantoprazole kien superjuri għal ranitidine fis-serħan missintomi talGORD
English: Study ID Design
Maltese: TAD-DEJTA PPREŻENTATI
English: Pantoprazole was noninferior to lansoprazole after 4 weeks of treatment
Maltese: Pantoprazole ma kienx inferjuri għal lansoprazole wara 4 ġimgħat ta' trattament
English: Shellac is obtained by purification of Lac, a secretion of the insect Laccifer Lacca Kerr (Coccidae).
Maltese: Tużax CONTROLOC Control wara d-data ta' skadenza li tidher fuq il-kartuna u fuq il-folja.
English: This study compared the efficacy of omeprazole 10 mg versus pantoprazole 20 mg at day 28 in patients without oesophagitis established by endoscopy.
Maltese: Dan l-istudju qabbel l-effikaċja ta' omeprazole 10 mg kontra pantoprazole 20 mg f'jum 28 f'pazjenti mingħajr esofaġite stabbilita b'endoskopija.
English: Normal oesophagus on endoscopy History of reflux symptoms (heartburn, acid eructation, pain on swallowing)
Maltese: Iperlipidimji u żidiet fil-lipidi (triglycerides, kolesterol);
English: 22/01/2002), Latvia (05/07/2004), Lithuania (30/12/1999), Luxembourg (26/01/2000, 29/09/2008), Netherlands (28/12/1998), Norway (08/10/2001), Poland (03/08/2006), Portugal (21/01/1999), Romania (29/12/2006), Slovak republic (26/04/2004), Slovenia (03/09/2002), Spain (22/06/1999), Sweden (28/01/1999, United Kingdom (17/03/2003), Antilles, Netherlands (25/08/1998), Argentina (04/11/1997, 21/04/1999), Aruba (24/11/1998), Australia (27/03/2000), 07/04/2000, 01/08/2008), Bosnia and Herzegowina (01/08/2001), Brazil (19/05/1998, 02/04/1998), Canada (01/10/2001, 10/03/2000), Chile (06/12/1999), Colombia (01/03/1999), Costa Rica (29/06/1999), Croatia (04/01/2006), Dominican Republic (10/02/1999), Ecuador (08/12/1998), Egypt (14/09/2004), Guatemala (20/04/1999), Honduras (13/08/1999), Hong Kong (24/06/1999), India (09/12/1998), Indonesia (06/10/2003), Iran (06/06/2004), Israel (28/10/1999), Jamaica (08/03/1999), Kazakhstan (14/04/2008), South Korea (08/10/1999), Kuwait (16/08/1999), Kyrgyzstan (09/08/1999), Macedonia (08/05/2007), Malaysia (23/01/2003), Marocco (29/01/2002), Mexico (10/06/1994, 25/11/1994), New Zealand (03/12/1998), Nicaragua (17/06/1999), Panama (09/09/1999), People's Republic of China (10/04/2001), Peru (10/04/1998), Philippines (16/08/2000), Russian Federation (28/04/2008), El Salvador (16/11/1999), Saudi Arabia (13/03/2001), Serbia (25/08/2004), Singapore (07/10/1999), South Africa (13/12/2000, 27/07/2005), Sudan (23/06/2005), Switzerland (26/03/1999), Taiwan (03/08/2000), Thailand (28/08/2000), Trinidad and Tobago (27/05/1999), Tunisia (12/06/2002), Ukraine (29/05/1999), United Arab Emirates (03/04/2000), United States of America (12/06/2001), Venezuela (12/02/2003), Vietnam (29/01/2003)
Maltese: Għid lit-tabib tiegħek immedjatament, qabel jew wara li tieħu din il-mediċina, jekk tinnota kwalunkwe mis-sintomi li ġejjin, li jistgħu jkunu sinjal ta' marda oħra li tkun iktar serja: - telf ta' piż mhux intenzjonat (mhux marbut ma' dieta jew programm ta' eżerċizzju) - rimettar, partikularment jekk ikun ripetut - tirremetti d-demm; dan jista' jidher bħala frak tal-kafè skur fir-rimettar tiegħek - tinnota d-demm fl-ippurgar tiegħek; li jista' jidher iswed jew qisu qatran - diffikultà biex tibla' jew uġigħ meta tibla' - tidher musfar u tħossok dgħajjef (anemija) - uġigħ fis-sider - uġigħ fl-istonku - dijarea severa u/jew persistenti, għax CONTROLOC Control kien assoċjat ma' żieda żgħira ta'
English: Rafe Suvarna Co-Rapporteur: Gonzalo Calvo Rojas
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Sample size
Maltese: Tqala u treddigħ
English: The study contained a treatment phase C; days 29-56, but again, this is not relevant to a non-prescription indication of no more than 28 days.
Maltese: L-istudju kien jinkludi fażi ta' trattament C; jiem 29-56, iżda għal darba oħra, din mhijiex rilevanti għal indikazzjoni mhux bir-riċetta ta' mhux aktar minn 28 ġurnata.
English: Additional information on the available safety data from Sweden where pantoprazole 20mg is available non-prescription were provided.
Maltese: Taqbiżx din id-doża rakkomandata ta' 20 mg ta' pantoprazole kuljum.
English: The findings of this study are in line with other published studies (Study VMG305 and M3-320), which showed that the efficacy of pantoprazole is noninferior to other PPIs (such as lansoprazole and esomeprazole).
Maltese: Is-sejbiet ta' dan l-istudju huma konsistenti ma' studji ppubblikati oħrajn (Studju VMG305 u M3-320), li wrew li l-effikaċja ta' pantoprazole mhijiex inferjuri għal PPIs oħra (bħal pereżempju lansoprazole u esomeprazole).
English: The drug substance specification includes tests for identification (IR and sodium), appearance of solution, optical rotation, water content (Karl Fisher), heavy metals, related substances (HPLC), assay (titration), particle size (laser diffraction) and residual solvents (GC).
Maltese: Madankollu, tista' tieħu CONTROLOC Control ma' antaċidi (eż. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, jew kumbinazzjonijiet tagħhom), jekk ikun meħtieġ.
English: The recommended dose is 20 mg pantoprazole (one tablet) per day.
Maltese: Kull pillola fiha 20 mg ta' pantoprazole (bħala sodium sesquihydrate).
English: ESP009
Maltese: MILL-EMEA
English: To support the efficacy of CONTROLOC control in the proposed indication and posology, the data from 17 clinical studies was provided in which the treatment of symptoms in patients with GORD was studied as primary or secondary criterion.
Maltese: B'mod ġenerali dan l-istudju ma jipprovdi l-ebda informazzjoni rilevanti analoga għall-perjodu inizjali ta' medikazzjoni mhux bir-riċetta sa 14-il ġurnata.
English: Baseline data
Maltese: Objettiv Ewlieni
English: In the second pivotal study BGI022 pantoprazole 20mg was shown to be significantly superior to ranitidine 150mg twice daily in the complete relief of heartburn after 2 weeks of treatment in patients with endoscopically normal oesophagus or mild oesophagitis.
Maltese: Dan l-istudju qabbel l-effikaċja ta' 20 mg pantoprazole darba kuljum ma' dik ta' 150 mg ranitidine darbtejn kuljum fil-fejqan mill-esofaġite u l-ħelsien mis-sintomi GORD wara t-trattament.
English: Endoscopic healing of GORD Stage I after 4 weeks of treatment
Maltese: Fejqan endoskopiku tal-Istadju I talGORD wara 4 ġimgħat ta' trattament
English: Tablet cores are produced by wet granulation.
Maltese: Ħu pillola waħda kuljum.
English: Batch analysis data on 6 batches from the proposed manufacturing sites has been provided.
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mill-umdità.
English: Pantoprazole: Ranitidine:
Maltese: Dan jista' jinkludi:
English: Similar results were shown in the published study M3
Maltese: Riżultati simili ntwrew fl-istudju ppubblikat M3
English: Non-clinical pharmacology and toxicology
Maltese: GĦAMLA FARMAĊEWTIKA
English: Table 4 Relief rate of heartburn in study BGI022
Maltese: Jistgħu jseħħu reazzjonijiet avversi tal-mediċina bħal sturdament u disturbi tal-vista (ara sezzjoni 4.8).
English: Pharmacodynamics
Maltese: Hypromellose
English: 60.1% to 69.8% Placebo
Maltese: Wara 14 u 28 jum, solliev totali mill-qrusa flistonku seħħ fi 62.9% sa 88.6% u 68.1% sa 92.3% tal-pazjenti, rispettivament.
English: • Adventitious Agents
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: Assessment of GI symptoms at day 14 and
Maltese: Metaboliżmu u tneħħija
English: Relief of heartburn in GORD Stage 0/I at day 28
Maltese: Serħan missintomi talGORD wara 7 u 28 jum ta' trattament
English: GERD stage I
Maltese: 4 ġimgħat
English: Gastro-resistant tablets have been developed in order to protect the drug substance which is acid labile from acidic effect of gastric fluid.
Maltese: L-investigazzjonijiet ma żvelaw l-ebda evidenza ta' indeboliment fil-fertilità jew effetti teratoġeniċi.
English: Total Pantoprazole 167 Ranitidine 171
Maltese: Sit tal-produzzjoni Oranienburg Lehnitzstraße 70-98, 16515
English: Primary Endpoint
Maltese: Edema periferali
English: In the second phase of the process the first coating suspension is sprayed onto the tablets in two phases.
Maltese: L-effetti mhux mixtieqa li ġejjin kienu rrappurtati bi pantoprazole.
English: Table 6 Overview of the design of the supportive studies Study ID Design
Maltese: 6.1 Lista ta' sustanzi mhux attivi
English: The product specification is standard for tablets (modified release) and contains tests with suitable limits for appearance, mean mass, disintegration time, loss on drying, identification, dissolution (UV determination), content uniformity, assay (HPLC), purity - impurities and degradation products (HPLC), microbial limits.
Maltese: Madankollu, l-ebda interazzjonijiet klinikament sinifikanti ma kienu osservati f'testijiet speċifiċi ma' carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline u kontraċettiv orali li fih levonorgestrel u ethinyl oestradiol.
English: Absolute Difference in Symptom Relief Rate Min/Max
Maltese: Disturbi filvista / vista mċajpra
English: NA NA NA
Maltese: NA NA
English: Dun Laoghaire, Co Dublin Ireland
Maltese: Dun Laoghaire, Co Dublin L-Irlanda
English: ASDASc,d,e
Maltese: ASDAS c,d,e
English: CI 95% for HRa
Maltese: HRa CI 95% għall
English: Week 52 Open-label
Maltese: Ġimgħa 52 Open-label
English: Lymphoma**,
Maltese: Limfoma**,
English: Investigations*
Maltese: Investigazzjonijiet*
English: JSN score 2.0 (1.2-2.8) 1.3 (0.5-2.1)
Maltese: Punteġġ JSN 2.0 (1.2-2.8) 1.3 (0.5-2.1) 0.5 (0-1.0)
English: Alopecia1),
Maltese: Alopeċja1),
English: Multiple sclerosis,
Maltese: Sklerosi multipla,
English: Rhabdomyolysis, Systemic lupus erythematosus
Maltese: Rabdomijoliżi, Lupus erythematosus sistemiku
English: PGA: Clear/minimal
Maltese: PGA: Xejn/minimali
English: Placebo/ MTXa
Maltese: Plaċebo /MTXa
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 March 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 ta' Marzu 2017
English: -56.2a a p < 0.001, adalimumab versus placebo
Maltese: -56.2a a p < 0.001, adalimumab kontra plaċebo
English: Hidradenitis Suppurativa Clinical Response (HiSCR)a
Maltese: Hidradenitis Suppurativa Rispons Kliniku (HiSCR)a
English: Sarcoidosis1), Vasculitis
Maltese: Sarcoidosis1), Infjammazzjoni vaskulari