FrancophonIA/ELRC3.0 huggingface dataset:
English: - Marketing authorisation number:
Estonian: MÜÜGILOA NUMBER
English: 344 Pantoprazole was superior to ranitidine in the relief of GORD symptoms
Estonian: 344 Pantoprasool oli GORD sümptomite leevendamisel ranitidiinist parem.
English: Pharmacokinetics
Estonian: Farmakokineetilised omadused
English: The CHMP noted that in the majority of the studies patients were included based on endoscopic examination rather than symptoms alone.
Estonian: GERD-i diagnoos nimetatud uuringutes põhines endoskoopilisel uuringul, välja arvatud üks uuring, milles patsientide lülitamine uuringusse põhines üksnes sümptomitel.
English: Additionally, in other studies efficacy of pantoprazole was compared to other PPIs (lansoprazole, esomeprazole) and it was found to be non-inferior to these PPIs in relieving symptoms of heartburn and acid regurgitation (Study VMG305 and M3-320).
Estonian: Lisaks võrreldi teistes uuringutes pantoprasooli tõhusust teiste prootonpumba inhibiitoritega (lansoprasool, esomeprasool) ja leiti, et see ei ole kõrvetiste ja happe regurgitatsiooni sümptomite leevendamisel teistest prootonpumba inhibiitoritest halvem (uuringud VMG305 ja M3-320).
English: Pan 20, Ran 300 once daily
Estonian: Pan 20, Ran 300 üks kord ööpäevas
English: 346 Pantoprazole and omeprazole
Estonian: 346 Pantoprasooli ja omeprasooli tõhusus oli sarnane.
English: Assessment of GI symptoms at day 14 and
Estonian: Seedetrakti sümptomite hindamine 14. ja 28. päeval
English: CSR = Clinical Study Report, N = Number of Patients, Eso = Esomeprazole, Lan = Lansoprazole, Niz = Nizatidine, Ome = Omeprazole, Pan = Pantoprazole, Pla = Placebo, Ran = Ranitidine, bid =twice daily
Estonian: Niz = nisatidiin; Ome = omeprasool; Pan = pantoprasool; Ran = ranitidiin; bid = kaks korda ööpäevas
English: “Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.”
Estonian: Refluksisümptomite (näiteks kõrvetised, happe regurgitatsioon) lühiaegne ravi täiskasvanutel.
English: Pan 20, Ran 300 once daily weeks
Estonian: Pan 20, Ran 300 üks kord ööpäevas nädalat
English: ASSESSMENT REPORT FOR CONTROLOC Control
Estonian: KUIDAS CONTROLOC CONTROL'i VÕTTA
English: This study compared the efficacy of 20 mg pantoprazole once daily with 150 mg twice daily ranitidine in healing of oesophagitis and freedom from GORD symptoms after treatment.
Estonian: Selles uuringus võrreldi üks kord ööpäevas manustatava 20 mg pantoprasooli tõhusust kaks korda ööpäevas manustatava 150 mg ranitidiiniga ösofagiidi ravimisel ja gastroösofageaalse reflukshaiguse sümptomite kõrvaldamisel pärast ravi.
English: Relief of heartburn in GORD Stage 0/I at day 28
Estonian: Kõrvetiste leevenemine GORD 0/I staadiumi korral 28. päeval
English: Relief of symptoms in GORD Stage A-D
Estonian: Sümptomite leevenemine GORD A kuni D staadiumite korral
English: Medicinal Product
Estonian: FARMAKOLOOGILISED OMADUSED
English: Endoscopic healing of GORD Stage II/III after 4 and 8 weeks of treatment
Estonian: GORD II/III staadiumi endoskoopiline paranemine nelja- ja kaheksanädalas e ravi järel
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.
Estonian: Selles uuringus võrreldi 20 mg, 40 mg või 80 mg pantoprasooli tõhusust ja talutavust ösofagiidi ravimisel ja gastroösofageaalse reflukshaiguse sümptomite kõrvaldamisel.
English: Efficacy
Estonian: TÕHUSAT KASUTAMIST
English: Pantoprazole was superior to ranitidine in the treatment of key GORD symptoms.
Estonian: Pantoprasool oli gastroösofageaalse reflukshaiguse võtmesümptomite ravimisel ranitidiinist parem.
English: Pan 20, Ran 150 bid weeks
Estonian: Pan 20, Ran 150 bid nädalat
English: Relief of symptoms in GORD Stage 0/I after 4 weeks of treatment
Estonian: Sümptomite leevenemine GORD 0/I staadiumi korral neljanädalase ravi järel
English: Pantoprazole and omeprazole were similarly effective
Estonian: 327 Pantoprasool ja omperasool olid sarnase tõhususega.
English: • Product Specification
Estonian: A. PAKENDI MÄRGISTUS
English: Relief of heartburn in GORD Stage I after 1 and 2 weeks of treatment
Estonian: Kõrvetiste leevenemine GORD I staadiumi korral ühe- ja kahenädalase ravi järel
English: Patients with new symptoms will be referred to a doctor.
Estonian: Patsientidele tuleb öelda, et nad pöörduksid arsti poole:
English: Tablets are packed in Alu/Alu blisters without cardboard reinforcement or Alu/Alu blisters with cardboard reinforcement (blister wallet).
Estonian: CONTROLOC Control on saadaval Al/Al blisterpakendis koos või ilma papist tugevduse(ga)ta.
English: 2.5 Pharmacovigilance
Estonian: 5.1 Farmakodünaamilised omadused
English: Relief of GORD symptoms after 2 weeks of treatment
Estonian: GORD sümptomite leevenemine kahenädalase ravi järel
English: Pantozol 20 mg gastro-resistant tablets
Estonian: CONTROLOC Control 20 mg gastroresistentsed tabletid Pantoprasool
English: Relief of key symptoms in GORD after 28 days
Estonian: GORD võtmesümptomite leevenemine 28 päeva järel
English: Pharmacodynamics
Estonian: Hüponatreemia
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).
Estonian: - Tableti kate: hüpromelloos, povidoon K25, titaandioksiid (E171), kollane raudoksiid (E172), propüleenglükool, metakrüülhappe- etüülakrülaat -kopolümeer (1:1), naatriumlaurüülsulfaat, polüsorbaat 80, trietüültsitraat.
English: Overall treatment duration without consultation of a doctor is limited to 4 weeks; if no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor.
Estonian: Kui sümptomid püsivad pärast 2-nädalast pidevat ravi, peab patsient pöörduma arsti poole.
English: No specific dose finding studies have been conducted for this application.
Estonian: See uuring ei oma taotluse jaoks olulist lisaväärtust.
English: respectively.
Estonian: Suukaudne.
English: This study compared the efficacy of omeprazole 10 mg versus pantoprazole 20 mg at day 28 in patients without oesophagitis established by endoscopy.
Estonian: Selles uuringus võrreldi 28. ravipäeval 10 mg omeprasooli tõhusust 20 mg pantoprasooliga patsientidel, kellel ösofagiidi kinnitamiseks polnud endoskoopiat tehtud.
English: 2.7 Data exclusivity
Estonian: 6.4 Säilitamise eritingimused
English: Pan 10, 20, 40, Pla weeks
Estonian: Pan 10, 20, 40, näiv ravim nädalat
English: In this study the efficacy of 20 mg pantoprazole was compared to 10 mg omeprazole at day 28 in patients with reflux oesophagitis.
Estonian: Selles uuringus võrreldi refluksösofagiidiga patsientidel 20 mg pantoprasooli tõhusust 10 mg omeprasooliga ööpäevas 28. päeval.
English: None of the 6 above-mentioned studies provide data to support the proposed indication and treatment duration that could not be derived from the other 11 studies provided in the application.
Estonian: - kliinilise tõhususe ja ohutuse toetuseks tugineb taotlus 17 kliinilise uuringu tulemusel, kuid mitte ükski kuuest ülalnimetatud uuringust ei sisalda andmeid kavandatud näidustuse ja ravikestuse kohta, mida ei oleks saanud tuletada ülejäänud 11 taotluses nimetatud uuringust, mistõttu ei esita kuus ülalnimetatud uuringut selliseid kliinilisi andmeid, mis tõeliselt mõjutaksid taotluse hindamist,
English: Relief of key symptoms in GORD after 14 days
Estonian: GORD võtmesümptomite leevenemine 14 päeva järel
English: Pantoprazole has been given a Marketing Authorisation in the following countries:
Estonian: Pantoprasooli kasutamisel on täheldatud järgmisi kõrvaltoimeid:
English: There are potential interactions with anticoagulants and with drugs, which bioavailability is pH dependent such as atanazavir.
Estonian: CONTROLOC Control võib vähendada nende toimeainete imendumist, mille biosaadavus sõltub pHst (nt ketokonasool).
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.
Estonian: Peavalu, pearinglus, kõhulahtisus, iiveldus, oksendamine, kõhupuhitus, kõhukinnisus, suukuivus, ebamugavustunne ja valu kõhus, lööve või nõgeslööve, nahasügelus, nõrkus, jõuetus või halb enesetunne, unehäired, maksaensüümide sisalduse suurenemine vereanalüüsis.
English: • Adverse events
Estonian: • MUUD TINGIMUSED
English: Pantoprazole was significantly more effective than nizatidine
Estonian: 243 Pantoprasool oli oluliselt tõhusam kui nisatidiin.
English: Pantoprazole was significantly more effective than ranitidine
Estonian: 209 Pantoprasool oli oluliselt tõhusam kui ranitidiin.
English: No further information on the contraindicated symptoms or the consequences of the treatment is available.
Estonian: Uuringutest ei ole ilmnenud andmeid teratogeensete toimete või toime kohta fertiilsusele.
English: This was considered acceptable.
Estonian: Ei ole kohaldatav.
English: In these studies between 57 and 78% of patients reported relief from heartburn at day 7 and 73-83% at day 14.
Estonian: Nimetatud uuringutes oli pantoprasooli grupis patsientide osakaal, kes vabanesid 7-päevase raviga täielikult kõrvetistest, vahemikus 54,0% kuni 80,6%.
English: Licensing status:
Estonian: Manustamisviis:
English: Table 9 Overview of adverse drug reactions
Estonian: Üldised häired ja manustamiskoha reaktsioonid
English: The most frequent adverse events (≥5%) included diarrhoea, headache, and nausea.
Estonian: Kõige sagedamini täheldatud kõrvaltoimed on kõhulahtisus ja peavalu, mis tekivad vähem kui 1% patsientidest.
English: • Risk and consequences of incorrect use
Estonian: • TINGIMUSED VÕI PIIRANGUD, MIS PUUDUTAVAD RAVIMI OHUTUT JA
English: The results also show an early onset of the clinical effect, with rates of complete relief of heartburn between 54.0% and 80.6% achieved after 7 days of treatment with pantoprazole 20 mg. A further improvement in the symptom relief rates was observed after 14 days and 28 days of treatment, respectively.
Estonian: Pärast 7-päevast ravi vabanes happelise regurgitatsiooni sümptomitest täielikult vahemikus 61,5% kuni 84,4% patsientidest, pärast 14-päevast ravi vahemikus 67,/% kuni 90,4% patsientidest ja pärast 28-päevast ravi vahemikus 75,2% kuni 94,5% patsientidest.
English: It acts by inhibiting the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of the parietal cells.
Estonian: Pantoprasool on substitueeritud bensimidasool, mis pärsib maos soolhappe sekretsiooni, avaldades spetsiifilist toimet mao parietaalrakkude prootonpumpadele.
English: The main serum metabolite is formed by demethylation at the 4-position of the pyridine ring, followed by conjugation with sulphate.
Estonian: Põhimetaboliit nii seerumis kui uriinis on desmetüülpantoprasool, mis konjugeeritakse sulfaadiga.
English: The absolute bioavailability of pantoprazole in healthy subjects is 77% and does not change at multiple dosing.
Estonian: Absoluutne biosaadavus tableti manustamisel on umbes 77%.
English: GCP
Estonian: BLISTER
English: The results show that symptom relief rates are largely independent of the initial GORD stage of the patients.
Estonian: Happelise refluksi sümptomitest vabanemine ei sõltunud nimetamisväärselt GERD-i staadiumist ravi alustamisel.
English: GERD stage I
Estonian: GORD I staadiumi paranemine
English: Randomisation
Estonian: Imetamine
English: Each gastro-resistant tablet contains 20 mg pantoprazole (equivalent of 22.6 mg of pantoprazole sodium sesquihydrate).
Estonian: Üks gastroresistentne tablett sisaldab 20 mg pantoprasooli (naatriumseskvihüdraadina).
English: It usually occurs after large meals or after eating spicy foods, citrus products, fats, chocolates or drinking alcohol.
Estonian: Sellisteks toiduaineteks on näiteks šokolaad, piparmünt, rohemünt, rasvane ja praetud toit, hapu toit, vürtsikas toit, tsitruseviljad ja tsitrusemahlad, tomatid.
English: Indirect danger to human health, even when the product is used correctly, may arise if the symptomatic treatment masks an underlying condition requiring medical attention.
Estonian: Üleannustamise korral, kui esinevad mürgistuse kliinilised sümptomid, tuleb rakendada tavapärast sümptomaatilist ja toetavat ravi.
English: Detailed description of the Pharmacovigilance system
Estonian: Ravimiohutusjärelvalvesüsteem
English: Table 1 provides an overview of key design elements of the main studies.
Estonian: Oluline teave mõningate CONTROLOC Control koostisainete suhtes.
English: 2.4 Clinical aspects
Estonian: 4.3 Vastunäidustused
English: Adverse drug reaction
Estonian: Interstitsiaalne nefriit
English: - Date of authorisation: - Marketing authorisation granted by:
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/ MÜÜGILOA UUENDAMISE KUUPÄEV
English: Relief of heartburn in GORD Stage 0
Estonian: Kõrvetiste leevenemine GORD 0 staadiumi korral
English: • Patient exposure
Estonian: Patsientide erigrupid
English: 2.8 Overall conclusions, risk/benefit assessment and recommendation
Estonian: 4.4 Hoiatused ja ettevaatusabinõud kasutamisel
English: symptoms after 7 and 28 days of
Estonian: GORD sümptomite leevenemine 7ja 28päevase ravi järel
English: It is extensively metabolised in the liver.
Estonian: Pantoprasool metaboliseeritakse peaaegu täielikult maksas.
English: Endoscopically established GORD stage I
Estonian: GORD I staadiumi endoskoopiline paranemine
English: No comparison with histamine2-receptor antagonist at doses used for non-prescription treatment of heartburn has been performed.
Estonian: Koostoimeid samaaegselt kasutatavate antatsiididega ei ole täheldatud.
English: 1.1 Submission of the dossier
Estonian: 6.1 Abiainete loetelu
English: 2 weeks
Estonian: 3 aastat.
English: The second step of the activation involves rearrangement of the molecular structure into a cyclic sulphenamide, a highly reactive intermediate of pantoprazole which can form disulphide (S-S) bonds with cysteine-containing proteins (or S-H group containing compounds such as glutathione), and thereby affects their structural and/or functional properties.
Estonian: Pantoprasool muutub oma aktiivseks vormiks - tsükliliseks sulfeenamiidiks - happelises keskkonnas parietaalrakkudes, kus ta pärsib ensüümi H+, K+ -ATPaasi, s.t. soolhappe produktsiooni viimast lüli maos.
English: CONTROLOC Control is presented in form of gastro-resistant tablets containing pantoprazole as an active substance.
Estonian: CONTROLOC Control sisaldab toimeainena pantoprasooli, mis blokeerib maohapet tootva „pumba“.
English: Pantozol 40 mg gastro-resistant tablets
Estonian: RAVIMVORM JA PAKENDI SUURUS 7 gastroresistentset tabletti 14 gastroresistentset tabletti
English: European Medicines Agency Evaluation of Medicines for Human Use
Estonian: RAVIMI VÄLJASTAMISTINGIMUSED Käsimüügiravim
English: Pantoprazole has a low interaction potential.
Estonian: Sarnaselt tervete isikutega on pantoprasooli poolväärtusaeg lühike.
English: Treatment of children is not intended in the present application in the non-prescription setting.
Estonian: Seda ravimit ei tohi raseduse ajal kasutada.
English: Number of patients with this adverse drug reaction
Estonian: 4.5 Koostoimed teiste ravimitega ja muud koostoimed
English: Endoscopic healing of GORD Stage I after 4 weeks of treatment
Estonian: GORD I staadiumi endoskoopiline paranemine neljanädalase ravi järel
English: BACKGROUND INFORMATION ON THE PROCEDURE
Estonian: TEKSTI LÄBIVAATAMISE KUUPÄEV
English: • User consultation
Estonian: PAKENDI INFOLEHT: INFORMATSIOON KASUTAJALE
English: No clinical studies were performed in special populations in support of this application.
Estonian: Kliinilistes uuringutes täheldati üksikjuhtudel eliminatsiooni pikenemist.
English: formulations of pantoprazole have equipotent effect on intragastric pH.
Estonian: Atazanaviiri imendumine on pH-st sõltuv.
English: CH2
Estonian: MUU
English: Outcomes and estimation
Estonian: Maksa ja sapiteede häired
English: Published studies suggest noninferiority of pantoprazole compared to other PPIs (Study VMG305 and M3
Estonian: Avaldatud uuringud näitavad, et pantoprasool ei ole teiste prootonpumba inhibiitoritega võrreldes halvem (uuring VMG305 ja M3-320)
English: The printed tablets are put into the container closure systems.
Estonian: Enne ravimi kasutamist lugege pakendi infolehte.
English: Relief of heartburn in GORD Stage 0/I
Estonian: Kõrvetiste leevenemine GORD 0/I
English: • Manufacture
Estonian: Tootja
English: Gastro-resistant tablets have been developed in order to protect the drug substance which is acid labile from acidic effect of gastric fluid.
Estonian: Pantoprasool vähendab mao happesust ja kutsub seeläbi esile plasma gastriinisisalduse suurenemise vastavalt happesuse langusele.
English: Endoscopic healing of GORD Stage I after 8 weeks of treatment
Estonian: GORD I staadiumi endoskoopiline paranemine kaheksanädalas e ravi järel
English: No increased risk of the treatment with pantoprazole in patients with renal impairment or impaired liver function has been detected in the post-marketing period.
Estonian: Kuigi kliinilistes farmakokineetilistes uuringutes ei ole samaaegsel manustamisel koos fenprokumooni ja varfariiniga koostoimeid täheldatud, on turustamisjärgsel perioodil teatatud üksikutest INR'i muutuste juhtudest samaaegse ravi jooksul.
English: Pantoprazole: Omeprazole:
Estonian: Nõgestõbi; angioödeem;
English: The pharmacokinetics is unaltered in patients with renal failure.
Estonian: Pantoprasooli farmakokineetika on ühesugune nii ühekordse kui ka korduva manustamise korral.
English: The initial application was submitted by Nycomed GmbH (EMEA/H/C/1013).
Estonian: MÜÜGILOA HOIDJA NIMI Nycomed GmbH
English: The worldwide post-marketing patient exposure based on sales data is approximately 665 million patients.
Estonian: Kõrvaltoimed tekivad umbes 5% pantoprasooliga ravitavatest patsientidest.
English: Clinical safety
Estonian: KLIINILISED ANDMED
English: 2.6 Legal Status
Estonian: 6.3 Kõlblikkusaeg
English: Non-prescription medicines for relief from heartburn include antacids, alginates, histamine2-receptor antagonist and proton pump inhibitors (PPIs).
Estonian: Ärge võtke CONTROLOC Control'i koos teiste ravimitega, mis vähendavad maos toodetava happe kogust, nagu näiteks teised prootonpumba inhibiitorid (omeprasool, lansoprasool või rabeprasool) või H2-retseptorite antagonistid (näiteks ranitidiin ja famotidiin).
English: No week 2 relief rate analysis was provided.
Estonian: Sümptomite leevenemise osakaalu analüüsi teise ravinädala kohta ei esitatud.
English: These included diarrhoea, abdominal pain, headache, nausea, chest pain and rash.
Estonian: Kõhulahtisus; iiveldus / oksendamine; kõhupuhitus; kõhukinnisus; suukuivus; valu ja ebamugavustunne kõhus;
English: Published studies showed noninferiority of pantoprazole compared to other PPIs (Study VMG305 and M3
Estonian: Avaldatud uuringud näitavad, et pantoprasool ei ole teiste prootonpumba inhibiitoritega võrreldes halvem (uuring VMG305 ja M3-320).
English: 2.1 Introduction
Estonian: 4.1 Näidustused
English: The eligibility for this multiple application to the centralised procedure was agreed upon by the EMEA/CHMP.
Estonian: Täpne informatsioon selle ravimi kohta on kättesaadav Euroopa Ravimiameti (EMEA) kodulehel: http://www.emea.europa.eu/.
English: Follow-up
Estonian: Lisainfo
English: RONKAINEN J et al., 1 High prevalence of gastroesophageal reflux symptoms and esophagitis with or without symptoms in the general adult Swedish population: A Kalixanda study report, Scandinavian Journal of Gastroenterology, 2005; 40: 275-/285
Estonian: CSR = (clinical study report) kliinilise uuringu aruanne; N = patsientide arv; ITT = (intention-to-treat) ravida kavatsetud patsientide arv; GORD = (gastro-oesophageal reflux disease) gastroösofageaalne reflukshaigus; Eso = esomeprasool; Lan = lansoprasool;
English: Pantoprazole was superior to ranitidine
Estonian: 338 Pantoprasool oli parem kui ranitidiin.
English: Results of 17 randomized controlled clinical studies (i.e. two pivotal and 15 supportive studies), in which pantoprazole 20mg was investigated with regard to relief of reflux symptoms as a primary or secondary endpoint, have been presented.
Estonian: 5690 gastroösofageaalse reflukshaigusega (GERD) patsienti, keda raviti 20 mg pantoprasooli monoteraapiaga, hõlmanud 17 uuringu retrospektiivses analüüsis hinnati happerefluksiga kaasnevaid sümptome nagu näiteks kõrvetised ja happe regurgitatsioon standardiseeritud metodoloogia abil.
English: As reflux symptoms are common and can affect the quality of life of the majority of sufferers a proton pump inhibitor is usually used as a first-line treatment.
Estonian: Mistahes põhjusel maohappesuse vähenemisel - sealhulgas ravi korral prootonpumba inhibiitoritegasuureneb seedetraktis tavaliselt elunevate bakterite arv mao limaskestas.
English: Symptom relief at 2 and 4 weeks of treatment
Estonian: Sümptomite leevenemine teisel ja neljandal ravinädalal
English: The full analysis set included all patients who were randomized and received trial medication at least once.
Estonian: Analüüsi valitud uuringutes pidi olema vähemalt üks refluksisümptomite registreerimine 2 nädalat pärast ravi alustamist.
English: The results of clinical studies where symptomatic relief of GORD was investigated show that pantoprazole provides relief of heartburn and acid regurgitation during a short-term treatment course (2-4 weeks).
Estonian: Mehhanismi, mis viib maokartsinoidide tekkeni substituteeritud bensimidasoolide toimel, on hoolikalt uuritud ning see võimaldab järeldada, et tegemist on teisese reaktsiooniga oluliselt suurenenud gastriinitasemetele, mis tekib rottidel pikaajalise ravi käigus pantoprasooli suurte annustega.
English: The applicant Nycomed GmbH submitted on 20 November 2008 an application for Marketing Authorisation to the European Medicines Agency (EMEA) for CONTROLOC Control, through the centralised procedure under Article 3 (2) (b) of Regulation (EC) No 726/2004.
Estonian: Müügiloa hoidja peab tagama, et enne ravimi turustamise alustamist ja ravimi turustamise vältel on olemas toimiv ravimiohutusjärelvalvesüsteem nagu on kirjeldatud müügiloa taotluse mooduli 1.8.1 versioonis 3.0 (07.11.2008).
English: Since the elimination half-life in these patients is still shorter than the dosing interval of 24 hours, no accumulation of pantoprazole was observed following multiple dosing.
Estonian: Kuna inimesel kasutatavad terapeutilised annused on väikesed, ei ole oodata kõrvaltoimeid kilpnäärme poolt.
English: Mild symptoms occurring 2 or more days per week or moderate to severe symptoms occurring more than 1 day per week are often considered troublesome for patients.
Estonian: Patsiendid, kellel on pika aja vältel esinenud korduvad seedehäire või kõrvetiste sümptomid, peavad regulaarselt külastama oma arsti.
English: There are no direct safety issues that preclude pantoprazole being available as a non-prescription medicine.
Estonian: Puuduvad adekvaatsed andmed pantoprasooli kasutamise kohta rasedatel naistel.
English: randomized, doubleblind, parallel group
Estonian: Nycomed GmbH Byk-Gulden-Str. 2
English: Allocation
Estonian: Maksapuudulikkus
English: Treatment Duration N (ITT)
Estonian: Perioodilised ohutusaruanded (POA)
English: Blinding (masking)
Estonian: Liigesvalu; lihasvalu
English: Since the manufacturing of the product is identical to the reference product, there is no requirement to specifically address the impurity profile of the new product from a nonclinical perspective.
Estonian: Ehkki seda ravimit on võimalik osta ilma retseptita, peate parima ravitulemuse saamiseks võtma CONTROLOC Control'i täpselt juhistele vastavalt.