FrancophonIA/ELRC3.0 huggingface dataset:
English: Genotoxicity (Chromosomal aberration and mouse lymphoma mutation assay) studies with aztreonam were negative.
Maltese: Studji dwar l-effett tossiku fuq il-ġeni (Aberrazzjoni kromosomali u assaġġ tal-mutazzjoni tal-limfoma fil-ġrieden) li saru b'aztreonam kienu negattivi.
English: EU/1/09/543/001: 28-day pack of Cayston
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/543/001: pakkett ta' 28 jum ta' Cayston
English: Cayston 75 mg powder and solvent for nebuliser solution.
Maltese: IL-PRODOTT MEDIĊINALI Cayston 75 mg trab u solvent għal soluzzjoni għan-nebulizzatur.
English: Since the plasma concentration of aztreonam following administration of Cayston (75 mg) is approximately 0.6 µg/ml, compared to serum levels of 54 µg/ml following administration of aztreonam for injection (500 mg), no safety issues associated with aztreonam overdose are anticipated.
Maltese: Billi l-konċentrazzjoni fil-plażma ta' aztreonam wara l-għoti ta' Cayston (75 mg) hi ta' madwar 0.6 µg/ml, meta mqabbla mal-livelli fis-serum ta' 54 µg/ml wara l-għoti ta' aztreonam għall-injezzjoni (500 mg), l-ebda problemi tas-sigurtà marbuta ma' doża eċċessiva ta' aztreonam ma huma mistennija.
English: Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0) 2 401 35 50
Maltese: Luxembourg/Luxemburg Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0)
English: or i.v.
Maltese: A.
English: Overall, 539 patients (78% adults) were treated in these studies.
Maltese: B'kollox, 539 persuna (78% adulti) kienu kkurati f'dawn l-istudji.
English: Press and hold the On/Off button on the Control Unit for a few seconds.
Maltese: Agħfas u żomm il-buttuna On/Off fuq l-eFlow Control Unit għal ftit sekondi.
English: The emergence of parenteral P. aeruginosa resistance to aztreonam or other beta-lactam antibiotics may have potential consequences for the treatment of acute pulmonary exacerbations with systemic antibiotics.
Maltese: L-iżvilupp ta' P. aeruginosa parenterali reżistenti għal aztreonam u antibijotiċi beta-lactam oħrajn jista' jkollu konsegwenzi potenzjali għall-kura ta' aggravamenti pulmonari akuti b'antibijotiċi sistemiċi.
English: One hour following a single dose of 75 mg inhaled aztreonam (at approximately peak plasma concentration), the mean plasma level in patients with CF was 0.59 µg/ml.
Maltese: Siegħa wara doża singola ta' 75 mg aztreonam miġbud man-nifs (bejn wieħed u ieħor filkonċentrazzjoni massima fil-plażma), il-medja tal-livell fil-plażma f'pazjenti bis-CF kienet ta' 0.59 µg/ml.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Cayston in one or more subsets of the paediatric population in cystic fibrosis patients with Pseudomonas aeruginosa pulmonary infection/colonisation (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Cayston f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika f'pazjenti b'fibrożi ċistika b'infezzjoni pulmonari/kolonizzazzjoni b'Pseudomonas aeruginosa (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Entry criteria included CF, FEV1 ≤ 75% predicted, stable pulmonary disease, a recent positive sputum culture for P. aeruginosa, and previous treatment with aerosolised antibiotics without demonstration of drug intolerance.
Maltese: Il-kriterji tal-parteċipazzjoni kienu jinkludu CF, FEV1 ≤ 75% imbassra, mard pulmonari stabbli, koltura riċenti ta' sputum pożittiva għal P. aeruginosa, u kura fil-passat b'antibijotiċi aerosolizzati mingħajr l-ebda sinjal ta' intolleranza għall-mediċina.
English: Among patients with multidrug-resistant P. aeruginosa, improvements in respiratory symptoms and pulmonary function were observed following treatment with Cayston.
Maltese: Fost pazjenti li kellhom P. aeruginosa reżistenti għal aktar minn mediċina waħda, kien osservat titjib fis-sintomi respiratorji u fil-funzjoni pulmonari wara lkura b'Cayston.
English: Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older.
Maltese: Cayston hu indikat għat-terapija soppressiva ta' infezzjonijiet pulmonari kroniċi minħabba Pseudomonas aeruginosa f'pazjenti bil-fibrożi ċistika (CF) li għandhom 6 snin jew aktar.
English: Powder vial: Type I amber glass vial with siliconised grey rubber stopper and aluminium tear off overseal with a blue cap.
Maltese: Kunjett bit-trab: Kunjett tal-ħġieġ ta' Tip I ta' kulur safrani b'tapp tal-lastku griż silikonizzat u għatu tal-aluminju tear off b'għatu blu.
English: cough, nasal congestion, wheezing, pharyngolaryngeal pain, dyspnoea
Maltese: sogħla, konġestjoni nażali, tħarħir, uġigħ faringolarinġeali, qtugħ ta' nifs
English: Systemic concentration of aztreonam following inhaled administration of Cayston is low compared to a standard dose of aztreonam for injection (approximately 1% of the concentration resulting from a dose of 500 mg aztreonam for injection).
Maltese: Il-konċentrazzjoni sistemika ta' aztreonam wara l-għoti permezz tal-ġbid man-nifs ta' Cayston hi baxxa meta mqabbla ma' doża standard ta' aztreonam għall-injezzjoni (madwar 1% talkonċentrazzjoni li tirriżulta minn doża ta' 500 mg ta' aztreonam għall-injezzjoni).
English: Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0) 2 401 35 79
Maltese: België/Belgique/Belgien Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0)
English: The Phase 2 and 3 placebo-controlled, registrational studies permitted comparison of plasma concentrations 1 hour post dose of Cayston by age (6 to 12 years, 13 to 17 years, and ≥ 18 years).
Maltese: L-istudji registrazzjonali ta' Fażi 2 u 3 ikkontrollati bil-plaċebo, ippermettew il-paragun ta' konċentrazzjonijiet fil-plażma siegħa wara l-għoti tad-doża ta' Cayston skont l-età (minn 6 sa 12-il sena, 13 sa 17-il sena, u ≥ 18-il sena).
English: Treatment-emergent persistent isolation (defined as absent at screening/baseline then present at 3 or more subsequent consecutive visits) of MSSA occurred in 6% of aztreonam-treated patients compared to 3% of TNS-treated patients.
Maltese: Iżolament persistenti li joħroġ mill-kura (definit bħala assenti fl-iscreening/linja bażi u mbagħad preżenti fi 3 viżti sussegwenti jew aktar) ta' MSSA seħħ f'6% tal-pazjenti kkurati b'aztreonam meta mqabbla ma' 3% ta' pazjenti kkurati b'TNS.
English: Replacing the Altera Nebuliser Handset
Maltese: Kif tibdel l-Altera Nebuliser Handset
English: GILEAD
Maltese: Tfal
English: The protein binding of aztreonam in plasma is approximately 77% at clinically relevant plasma concentrations.
Maltese: It-twaħħil ta' aztreonam mal-proteini fil-plażma huwa madwar 77% f'konċentrazzjonijiet fil-plażma ta' rilevanza klinika.
English: Data from these studies revealed minimal differences in mean plasma aztreonam concentrations between age groups in patients receiving Cayston 3 times a day.
Maltese: Dejta minn dawn l-istudji żvelat differenzi minimi filmedja tal-konċentrazzjonijiet fil-plażma ta' aztreonam bejn il-gruppi ta' età f'pazjenti li kienu qed jirċievu Cayston 3 darbiet kuljum.
English: Inhalation of nebulised solutions may induce a cough reflex which could aggravate underlying conditions (see section 4.4).
Maltese: Il-ġbid man-nifs ta' soluzzjonijiet nebulizzanti jista' jikkaġuna azzjoni riflessa ta' sogħla li tista' tiggrava kundizzjonijiet diġà eżistenti (ara sezzjoni 4.4).
English: Currently available data are described in section 5.1 but no recommendation on posology can be given.
Maltese: Attwalment id-data disponibbli hija deskritta fit-taqsima 5.1 iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: Gently tap the amber vial containing the Cayston so that the powder settles at the bottom.
Maltese: - Tippreparax Cayston qabel ma tkun lest/a biex tieħu doża.
English: Lung function test decreased
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Assessment of adverse reactions is based on experience in four Phase 3 clinical studies involving CF patients with chronic P. aeruginosa infection and post-marketing spontaneous reporting.
Maltese: L-evalwazzjoni ta' reazzjonijiet avversi hi bbażata fuq esperjenza fi studji kliniċi ta' Fażi 3 li jinvolvu pazjenti bis-CF b'infezzjoni kronika b'P. aeruginosa u rappurtaġġ spontanju ta' wara t-tqegħid fissuq.
English: Pharmacokinetics in special populations
Maltese: GĦAMLA FARMAĊEWTIKA
English: Each powder vial contains 75 mg aztreonam.
Maltese: Kull kunjett bit-trab fih 75 mg ta' aztreonam.
English: How to take Cayston
Maltese: Tiħux Cayston
English: The known mechanism of resistance to aztreonam mediated by acquisition of genes involves acquisition of extended spectrum beta-lactam enzymes (ESBLs) that hydrolyse the fourmember, nitrogen-containing ring of aztreonam.
Maltese: Il-mekkaniżmu magħruf tar-reżistenza għal aztreonam, medjat mill-akkwist ta' ġeni, jinvolvi l-akkwist ta' extended spectrum beta-lactam enzymes (ESBLs) li jidrolizzaw iċ-ċirku li fih erba' partijiet, bin-nitrogen, ta' aztreonam.
English: Marketing Authorisation Holder:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Investigations: Common:
Maltese: Investigazzjonijiet:
English: Cayston should not be used with any other type of handset or aerosol head.
Maltese: Cayston m'għandux jintuża ma' kwalunkwe tip ieħor ta' handset jew aerosol head.
English: Plasma aztreonam concentrations in paediatric patients aged 3 months to < 6 years are comparable to those observed for children > 6 years, adolescents and adults.
Maltese: Il-konċentrazzjonijiet ta' aztreonam fil-plażma f'pazjenti pedjatriċi b'età minn 3 xhur sa < 6 snin huma komparabbli ma' dawk osservati għal tfal b'età ta' > 6 snin, adoloxxenti u adulti.
English: Treatments were administered for three cycles of 28 days on therapy followed by 28 days off therapy.
Maltese: Il-kuri ngħataw għal tliet ċikli ta' 28 jum fuq terapija segwiti minn 28 jum mingħajr terapija.
English: Gilead Sciences Ireland UC Tel: +353 (0) 214 825 999
Maltese: Tel: + 353 (0) 214 825 999
English: Do not try to take Cayston using any other type of nebuliser handset (including the eFlow rapid handset).
Maltese: Tippruvax tieħu Cayston billi tuża kwalunkwe tip ieħor ta' nebuliser handset (li jinkludi lhandset eFlow rapid).
English: The Altera Nebuliser Handset is designed to last for three 28-day courses of Cayston when used as directed.
Maltese: L-Altera Nebuliser Handset hu maħsub biex iservi għal 3 korsijiet ta' 28 jum ta' Cayston meta jintuża skond l-istruzzjonijiet.
English: It is recommended that Cayston be administered immediately after reconstitution with solvent.
Maltese: Hu rakkomandat li Cayston jingħata immedjatament wara r-rikostituzzjoni bis-solvent.
English: General disorders and administration site conditions: Very common:
Maltese: Disturbi ġenerali u kundizzjonijiet ta' mnejn jingħata:
English: After a few seconds, an aerosol mist will begin to flow into the Aerosol Chamber of the Altera Nebuliser Handset.
Maltese: Wara ftit sekondi, iċ-ċpar tal-aerosol ser jibda jnixxi ġol-Kompartiment tal-Aerosol tal-Altera Nebuliser Handset.
English: One amber-coloured vial of Cayston with a blue cap.
Maltese: Kunjett wieħed ta' lewn safrani ta' Cayston b'għatu blu.
English: Gilead Sciences Netherlands B.V. Tel: + 31 (0) 20 718 36 98
Maltese: Tel: + 31 (0) 20 718 36 98
English: Patients were randomised in a 1:1 ratio to receive either aztreonam (75 mg) administered by inhalation 3 times a day or TNS (300 mg) administered 2 times a day.
Maltese: Il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 1:1 biex jirċievu jew aztreonam (75 mg) mogħti permezz ta' ġbid man-nifs 3 darbiet kuljum jew TNS (300 mg) mogħti darbtejn kuljum.
English: In the limited subgroup of patients who received inhaled tobramycin for less than 84 days in the previous 12 months (n = 40), lung function improvements at Day 28 and across three 28-day treatment courses were numerically smaller among aztreonam-treated patients than TNS-treated patients.
Maltese: Fis-sottogrupp limitat ta' pazjenti li rċivew tobramycin li jinġibed man-nifs għal inqas minn 84 jum fit-12-il xahar ta' qabel (n = 40), it-titjib fil-funzjoni pulmonari f'jum 28 u matul it-tliet korsijiet ta' kura ta' 28 jum, kien numerikament iżgħar fost pazjenti kkurati b'aztreonam milli f'pazjenti kkurati b'TNS.
English: An association between persistent isolation of MRSA and worse clinical outcome has been reported in the literature.
Maltese: Rabta bejn iżolament persistenti ta' MRSA u riżultat kliniku agħar ġiet irrappurtata fil-letteratura medika.
English: Cayston 75 mg powder for nebuliser solution aztreonam
Maltese: Kif tieħu Cayston billi tuża l-Altera Nebuliser Handset
English: antipseudomonal antibiotics related to respiratory events compared to TNS-treated patients (p = 0.0025).
Maltese: Pazjenti kkurati b'aztreonam damu aktar żmien qabel kellhom bżonn ta' antibijotiċi antipsewdomonali i.v. assoċjati ma' avvenimenti respiratorji meta mqabbla ma' pazjenti kkurati b'TNS (p = 0.0025).
English: May be stored outside a refrigerator but below 25°C for up to 28 days.
Maltese: Jistgħu jinħażnu wkoll barra millfriġġ iżda taħt temperatura ta' 25°C sa 28 jum.
English: Cayston is contained in a 2 ml amber glass vial with a grey rubber stopper and aluminium tear-off overseal with a blue cap.
Maltese: Cayston jinsab f'kunjett tal-ħġieġ ta' lewn safrani b'tapp griż tal-lastku u overseal tal-aluminju tear-off b'għatu blu.
English: During the 6-month randomised phase of study GS-US-205-0110, treatment-emergent isolation of MSSA and MRSA was observed more commonly among aztreonam-treated patients than Tobramycin Nebuliser Solution (TNS)-treated patients.
Maltese: Matul il-fażi ta' studju GS-US-205-0110 li dam 6 xhur li fih il-parteċipanti ntgħażlu b'mod każwali, iżolament li joħroġ mill-kura ta' MSSA u MRSA ġie osservat b'mod iktar komuni fost pazjenti kkurati b' aztreonam milli f'pazjenti kkurati b'Tobramycin Nebuliser Solution (TNS).
English: Cayston is a white to off-white powder and solvent for nebuliser solution.
Maltese: Cayston għandu jkun rikostitwit biss bis-solvent ipprovdut.
English: Studies were conducted using the Altera Nebuliser System to administer Cayston.
Maltese: L-istudji saru bl-użu tal-Altera Nebuliser System biex jingħata Cayston.
English: Recovery data indicate that about 10% of the dose is excreted as this metabolite.
Maltese: Id-dejta tal-irkupru tindika li madwar 10% tad-doża titneħħa bħala dan il-metabolit.
English: Squeeze out the contents completely into the vial (Figure 2).
Maltese: Agħfas u oħroġ il-kontenut kompletament għal ġol-kunjett (Figura 2).
English: Cystic fibrosis, also known as mucoviscidosis, is a life-threatening inherited disease that affects the mucus glands of internal organs, especially the lungs, but also of the liver, pancreas, and the digestive system.
Maltese: Il-fibrożi ċistika, magħrufa wkoll bħala mukovixxidosi, hi marda ta' periklu għall-ħajja li tintiret u li taffettwa l-glandoli mukużi tal-organi interni, speċjalment il-pulmun, iżda wkoll tal-fwied, tal-frixa, u tas-sistema diġestiva.
English: Powder
Maltese: Trab
English: Approximately 10% of the total inhaled aztreonamdose is excreted in the urine as unchanged drug, as compared to 60-65% following intravenous administration of aztreonam for injection.
Maltese: Madwar 10% tad-doża totali ta' aztreonam miġbud man-nifs titneħħa fl-awrina bħala mediċina mhux mibdula, meta mqabbel ma' 60-65% wara l-għoti ġol-vini ta' aztreonam għall-injezzjoni.
English: Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888
Maltese: Tel: + 353 (0) 1 686 1888
English: All patients were treated with Tobramycin Nebuliser Solution (TNS) 300 mg, 2 times a day in the four weeks immediately prior to receiving Cayston or placebo either 2 or 3 times a day for 28 days.
Maltese: Il-pazjenti kollha kienu kkurati bi Tobramycin Nebuliser Solution (TNS) 300 mg, darbtejn kuljum fl-erba' ġimgħat immedjatament qabel ma rċivew Cayston jew il-plaċebo, jew darbtejn jew 3 darbiet kuljum għal 28 jum.
English: Systemically absorbed aztreonam is eliminated about equally by active tubular secretion and glomerular filtration.
Maltese: Aztreonam assorbit b'mod sistemiku jitneħħa bejn wieħed u ieħor b'mod ugwali mit-tnixxija tubulari attiva kif ukoll millfiltrazzjoni glomerulari.
English: Common side effects (affects 1 to 10 users in 100) - Difficulty breathing - Chest discomfort - Runny nose - Coughing up blood - Rash
Maltese: Effetti sekondarji mhux komuni (jaffettwaw minn 1 sa 10 utenti minn kull 1,000) - Nefħa tal-ġogi
English: The adjusted mean actual change from baseline in FEV1 % predicted across 3 treatment courses was 2.05 and -0.66 in the Cayston and TNS groups, respectively (treatment difference: 2.70; p = 0.0023; 95% CI: 0.98, 4.43).
Maltese: Il-medja aġġustata mil-linja bażi tal-bidla attwali f'FEV1 % imbassra matul it-3 korsijiet ta' kura kienet 2.05 u -0.66 fil-gruppi ta' Cayston u TNS, rispettivament (differenza fil-kura:
English: The in vitro antimicrobial susceptibility test methods used for parenteral aztreonam therapy can be used to monitor the susceptibility of P. aeruginosa isolated from CF patients.
Maltese: Il-metodi talittestjar tas-suxxettibbilità in vitro kontra l-mikrobi li jintużaw għat-terapija parenterali b'aztreonam, jistgħu jintużaw biex jimmonitorjaw is-suxxettibbilità ta' iżolati ta' P. aeruginosa minn pazjenti bisCF.
English: The following side effects have been observed after the use of aztreonam for injection, but not after taking Cayston: swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing, sweating, skin irritation and flaking, itchy rash, flushing, small red spots and very rarely, blistering of the skin.
Maltese: L-effetti sekondarji li ġejjin kienu osservati wara l-użu ta' aztreonam għall-injezzjoni, iżda mhux wara li ttieħed Cayston: nefħa tal-wiċċ, xufftejn, ilsien u/jew gerżuma b'diffikultà biex tibla' jew tieħu nnifs, tagħriq, irritazzjoni tal-ġilda u raxx bil-qxur u bil-ħakk, fwawar, tikek żgħar ħomor, u b'mod rari ħafna, infafet fuq il-ġilda.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CAYSTON INNER CARTON
Maltese: Jekk tieħu Cayston aktar milli suppost
English: Pregnancy
Maltese: Rikostituzzjoni
English: A decrease in P. aeruginosa susceptibility to aztreonam and other beta-lactam antibiotics was observed in clinical studies of Cayston.
Maltese: Tnaqqis fis-suxxettibbilità ta' P. aeruginosa għal aztreonam jew antibijotiċi beta-lactam oħrajn ġie osservat fi studji kliniċi dwar Cayston.
English: If not used immediately, the prepared solution must be stored at 2°C - 8°C and used within 8 hours.
Maltese: Jekk ma tintużax immedjatament, issoluzzjoni ppreparata trid tinħażen f'temperatura ta' 2°C - 8°C u tintuża fi żmien 8 sigħat.
English: The full EPAR for Somac Control 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: This summary was last updated in 03-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'03-2013.
English: In the second study, 70% of the patients taking pantoprazole (121 out of 172) and 59% of those talking ranitidine (102 out of 172) had no heartburn after two weeks of treatment.
Maltese: Fit-tieni studju, 70% tal-pazjenti li kienu qegħdin jieħdu pantoprazole (121 minn 172) u 59% ta' dawk li kienu qegħdin jieħdu ranitidine (102 minn 172) ma kellhomx qrusa fl-istonku wara ġimagħtejn ta' kura.
English: In the first study, 74% of the patients taking pantoprazole (80 out of 108) and 43% of those taking placebo (48 out of 111) had no heartburn after two weeks.
Maltese: Fl-ewwel studju, 74% tal-pazjenti li kienu qegħdin jieħdu pantoprazole (80 minn 108) u 43% ta' dawk li kienu qegħdin jieħdu plaċebo (48 minn 111) ma kellhomx qrusa fl-istonku wara ġimagħtejn.
English: The active substance in Somac Control, pantoprazole, is a proton pump inhibitor.
Maltese: Is-sustanza attiva f'Somac Control, pantoprazole, hija inibitur tal-pompa tal-proton.
English: Pantoprazole-containing medicines have been available in the European Union (EU) since 1994.
Maltese: Mediċini li fihom pantoprazole ilhom disponibbli fl-Unjoni Ewropea (UE) sa mill-1994.
English: Somac Control is a medicine that contains the active substance pantoprazole.
Maltese: Somac Control huwa mediċina li fiha s-sustanza attiva pantoprazole.
English: The first study compared pantoprazole with placebo (a dummy treatment) in 219 adults, and the second compared it with ranitidine (another medicine used to treat acid reflux symptoms) in 344 adults.
Maltese: L-ewwel studju qabbel pantoprazole ma' plaċebo (kura finta) f'219-il adult, u t-tieni qabblu ma' ranitidine (mediċina oħra li tintuża fil-kura tas-sintomi ta' rifluss tal-aċidu) fi 344 adult.
English: This is a summary of the European public assessment report (EPAR) for Somac Control.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Somac Control.
English: Somac Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Somac.
Maltese: Somac Control huwa simili għal ‘mediċina ta' referenza' msejħa Somac li hija diġà awtorizzata fl-Unjoni Ewropea (UE).
English: The European Commission granted a marketing authorisation valid throughout the EU for Somac Control on 12 June 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Somac Control fit-12 ta' Ġunju 2009.
English: The applicant also presented information from two main studies looking at the effects of pantoprazole 20 mg in a total of 563 adults who had symptoms of acid reflux, including at least one episode of heartburn in the three days before the studies began.
Maltese: L-applikant ippreżenta wkoll tagħrif minn żewġ studji ewlenin li eżaminaw l-effetti ta' pantoprazole 20 mg f'total ta' 563 adult li kellhom is-sintomi ta' rifluss tal-aċidu, inkluż mill-inqas episodju wieħed ta' qrusa fl-istonku fit-tlett ijiem qabel bdew l-istudji.
English: Other information about Somac Control
Maltese: Informazzjoni oħra dwar Somac Control
English: What is the risk associated with Somac Control?
Maltese: X'inhu r-riskju assoċjat ma' Somac Control?
English: It must not be used with atazanavir (a medicine used to treat human immunodeficiency virus [HIV] infection).
Maltese: M'għandux jintuża ma' atazanavir (mediċina li tintuża għall-kura ta' infezzjoni bil-virus tal-immunodefiċjenza umana
English: What is Somac Control?
Maltese: X'inhu Somac Control?
English: The CHMP noted that pantoprazole 20 mg was effective in the short-term treatment of reflux symptoms and that there is a long safety experience with the medicine as a prescription medicine.
Maltese: Is-CHMP innota li pantoprazole 20 mg kien effettiv fil-kura għal żmien qasir tas-sintomi ta' rifluss u li hemm esperjenza twila ta' sigurtà bil-mediċina bħala mediċina bir-riċetta.
English: The reference medicine, Somac, is only available with a prescription.
Maltese: Il-mediċina ta' referenza, Somac, hija disponibbli biss permezz ta' riċetta tat-tabib.
English: Somac Control is used for the short-term treatment of the symptoms of acid reflux in adults.
Maltese: Somac Control jintuża għall-kura għal żmien qasir tas-sintomi ta' rifluss tal-aċidu fl-adulti.
English: It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining that pump acid into the stomach.
Maltese: Taħdem billi timblokka ‘l-pompi tal-proton', proteini li jinsabu f'ċelloli speċjalizzati fil-kisja tal-istonku li jippumpjaw l-aċidu fl-istonku.
English: Pantoprazole was more effective than placebo and ranitidine at improving the symptoms of acid reflux.
Maltese: Pantoprazole kien iktar effettiv mill-plaċebo u minn ranitidine fit-titjib tas-sintomi ta' rifluss tal-aċidu.
English: Because pantoprazole has been in use for many years, the applicant presented data from the scientific literature.
Maltese: Minħabba li pantoprazole ilu jintuża għal ħafna snin, l-applikant ippreżenta dejta mill-materjal xjentifiku stampat.