FrancophonIA/ELRC3.0 huggingface dataset:
English: inflammation of the blood vessels, inflamed pancreas, inflammation of the stomach lining (gastritis), inflammation of the liver, yellowing of the skin (jaundice), increased levels of hepatic enzymes with jaundice, rapid swelling of skin and mucosa (angioedema), severe skin reactions, hives (urticaria), severe allergic reactions with blistering eruptions of the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson-Syndrome), increased sensitivity of the skin to sun, increased muscle tension.
Estonian: üksikjuhtudel kontrollimatud tõmblevad või vappuvad liigutused, südameatakk, ebaregulaarsed südamelöögid, veresoontepõletik, kõhunäärmepõletik, mao limaskesta põletik (gastriit), maksapõletik, naha kollasus (kollatõbi), maksaensüümide kontsentratsiooni tõus koos kollatõvega, õhupuudus, naha ja limaskestade kiire tursumine (angioödeem), rasked nahareaktsioonid, nõgestõbi (urtikaaria), rasked allergilised reaktsioonid naha ja limaskestade villilise lööbega (eksfoliatiivne dermatiit, StevensiJohnsoni sündroom), naha suurenenud päikesetundlikkus, suurenenud lihasepinge.
English: Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Estonian: Üks tablett sisaldab 80 mg telmisartaani ja 5 mg amlodipiini (amlodipiinbesilaadina).
English: Twynsta 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg alone.
Estonian: Twynsta 40 mg/10 mg võib kasutada patsientidel, kelle vererõhk ei ole piisavalt langenud ainult amlodipiini 10 mg annusega.
English: Uncommon visual impairment
Estonian: Immuunsüsteemi häired Harv
English: Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Estonian: Üks tablett sisaldab 40 mg telmisartaani ja 5 mg amlodipiini (amlodipiinbesilaadina).
English: The incidence of dry cough was significantly lower in patients treated with telmisartan than in those given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two antihypertensive treatments.
Estonian: Kliinilistes uuringutes, milles võrreldi otseselt telmisartaani ja angiotensiini konverteeriva ensüümi inhibiitoreid, esines kuiv köha telmisartaanravi saanud patsientidel tunduvalt harvemini
English: Package leaflet: Information for the user Twynsta 80 mg/10 mg tablets Telmisartan/Amlodipine
Estonian: Pakendi infoleht: teave kasutajale Twynsta 80 mg/10 mg tabletid Telmisartaan/Amlodipiin
English: Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Estonian: Üks tablett sisaldab 80 mg telmisartaani ja 10 mg amlodipiini (amlodipiinbesilaadina).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Estonian: TOIMEAINE(TE) SISALDUS Iga tablett sisaldab 40 mg telmisartaani ja 5 mg amlodipiini (amlodipiinbesilaadina).
English: Respiratory, thoracic and mediastinal disorders Uncommon cough dyspnoea dyspnoea, rhinitis
Estonian: Respiratoorsed, rindkere ja mediastiinumi häired Aeg-ajalt
English: What Twynsta looks like and contents of the pack Twynsta 40 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the white layer.
Estonian: Twynsta 40 mg/5 mg tabletid on sinised ja valged ovaalse kujuga kahekihilised tabletid, mille valgele kihile on graveeritud toote kood A1 ja firma logo.
English: Package leaflet: Information for the user Twynsta 80 mg/5 mg tablets Telmisartan/Amlodipine
Estonian: Pakendi infoleht: teave kasutajale Twynsta 80 mg/5 mg tabletid Telmisartaan/Amlodipiin
English: EU/1/10/648/001 (14 tablets) EU/1/10/648/002 (28 tablets) EU/1/10/648/003 (30 x 1 tablets) EU/1/10/648/004 (56 tablets) EU/1/10/648/005 (90 x 1 tablets) EU/1/10/648/006 (98 tablets)
Estonian: EU/1/10/648/001 (14 tabletti) EU/1/10/648/002 (28 tabletti) EU/1/10/648/003 (30 x 1 tabletti) EU/1/10/648/004 (56 tabletti) EU/1/10/648/005 (90 x 1 tabletti) EU/1/10/648/006 (98 tabletti)
English: Package leaflet: Information for the user Twynsta 40 mg/10 mg tablets Telmisartan/Amlodipine
Estonian: Pakendi infoleht: teave kasutajale Twynsta 40 mg/10 mg tabletid Telmisartaan/Amlodipiin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Estonian: TOIMEAINE(TE) SISALDUS Iga tablett sisaldab 80 mg telmisartaani ja 5 mg amlodipiini (amlodipiinbesilaadina).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Estonian: TOIMEAINE(TE) SISALDUS Iga tablett sisaldab 40 mg telmisartaani ja 10 mg amlodipiini (amlodipiinbesilaadina).
English: Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Estonian: Üks tablett sisaldab 40 mg telmisartaani ja 10 mg amlodipiini (amlodipiinbesilaadina).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Estonian: TOIMEAINE(TE) SISALDUS Iga tablett sisaldab 80 mg telmisartaani ja 10 mg amlodipiini (amlodipiinbesilaadina).
English: EU/1/10/648/001 (14 tablets) EU/1/10/648/002 (28 tablets) EU/1/10/648/003 (30 x 1 tablets) EU/1/10/648/004 (56 tablets) EU/1/10/648/005 (90 x 1 tablets) EU/1/10/648/006 (98 tablets) EU/1/10/648/007 (360 (4 x 90 x 1) tablets)
Estonian: EU/1/10/648/001 (14 tabletti) EU/1/10/648/002 (28 tabletti) EU/1/10/648/003 (30 x 1 tabletti) EU/1/10/648/004 (56 tabletti) EU/1/10/648/005 (90 x 1 tabletti) EU/1/10/648/006 (98 tabletti) EU/1/10/648/007 (360 (4 x 90 x 1) tabletti)
English: Package leaflet: Information for the user Twynsta 40 mg/5 mg tablets Telmisartan/Amlodipine
Estonian: Pakendi infoleht: teave kasutajale Twynsta 40 mg/5 mg tabletid Telmisartaan/Amlodipiin
English: tendon pain (tendinitis like symptoms)
Estonian: Kõõlusvalu (kõõlusepõletikule omased sümptomid)
English: What Twynsta looks like and contents of the pack Twynsta 80 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the white layer.
Estonian: Twynsta 80 mg/5 mg tabletid on sinised ja valged ovaalse kujuga kahekihilised tabletid, mille valgele kihile on graveeritud toote kood A3 ning firma logo.
English: Blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the white layer.
Estonian: Sinine ja valge ovaalse kujuga kahekihilised tabletid, mille valgele kihile on graveeritud toote kood A1 ning firma logo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/007 (360 (4 x 90 x 1) tablets)
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/10/648/007 (360 (4 x 90 x 1) tabletti)
English: What Twynsta looks like and contents of the pack Twynsta 80 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the white layer.
Estonian: Twynsta 80 mg/10 mg tabletid on sinised ja valged ovaalse kujuga kahekihilised tabletid, mille valgele kihile on graveeritud toote kood A4 ning firma logo.
English: Sleepiness, migraine, headache, tingling or numbness of the hands or feet, feeling of spinning (vertigo), slow heart rate, palpitations (awareness of your heart beat), low blood pressure (hypotension), dizziness on standing up (orthostatic hypotension), flushing, cough, stomach ache (abdominal pain), diarrhoea,
Estonian: Unisus, migreen, peavalu, kämmalde ja labajalgade torkimis- või tuimustunne, peapööritus, südamelöökide aeglustumine, südamepekslemine (tunnete oma südamelööke), madal vererõhk
English: EU/1/10/648/015 (14 tablets) EU/1/10/648/016 (28 tablets) EU/1/10/648/017 (30 x 1 tablets) EU/1/10/648/018 (56 tablets) EU/1/10/648/019 (90 x 1 tablets) EU/1/10/648/020 (98 tablets)
Estonian: EU/1/10/648/015 (14 tabletti) EU/1/10/648/016 (28 tabletti) EU/1/10/648/017 (30 x 1 tabletti) EU/1/10/648/018 (56 tabletti) EU/1/10/648/019 (90 x 1 tabletti) EU/1/10/648/020 (98 tabletti)
English: Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels in the blood, shortness of breath, bloating, increased sweating, kidney damage including sudden inability of the kidneys to work, increased levels of creatinine.
Estonian: Aeg-ajalt esinevad kõrvaltoimed (võivad esineda kuni 1 kasutajal 100-st): Kuseteede infektsioonid, ülemiste hingamisteede infektsioonid (nt kurguvalu, nina kõrvalurgete põletik, nohu), vere punaliblede vähesus (aneemia), kaaliumi kõrge kontsentratsioon veres, õhupuudus, kõhupuhitus, rohke higistamine, neerukahjustus, sh neerufunktsiooni lakkamine, kreatiniini taseme tõus.
English: EU/1/10/648/022 (14 tablets) EU/1/10/648/023 (28 tablets) EU/1/10/648/024 (30 x 1 tablets) EU/1/10/648/025 (56 tablets) EU/1/10/648/026 (90 x 1 tablets) EU/1/10/648/027 (98 tablets)
Estonian: EU/1/10/648/022 (14 tabletti) EU/1/10/648/023 (28 tabletti) EU/1/10/648/024 (30 x 1 tabletti) EU/1/10/648/025 (56 tabletti) EU/1/10/648/026 (90 x 1 tabletti) EU/1/10/648/027 (98 tabletti)
English: EU/1/10/648/022 (14 tablets) EU/1/10/648/023 (28 tablets) EU/1/10/648/024 (30 x 1 tablets) EU/1/10/648/025 (56 tablets) EU/1/10/648/026 (90 x 1 tablets) EU/1/10/648/027 (98 tablets) EU/1/10/648/028 (360 (4 x 90 x 1) tablets)
Estonian: EU/1/10/648/022 (14 tabletti) EU/1/10/648/023 (28 tabletti) EU/1/10/648/024 (30 x 1 tabletti) EU/1/10/648/025 (56 tabletti) EU/1/10/648/026 (90 x 1 tabletti) EU/1/10/648/027 (98 tabletti) EU/1/10/648/028 (360 (4 x 90 x 1) tabletti)
English: What Twynsta looks like and contents of the pack Twynsta 40 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the white layer.
Estonian: Twynsta 40 mg/10 mg tabletid on sinised ja valged ovaalse kujuga kahekihilised tabletid, mille valgele kihile on graveeritud toote kood A2 ning firma logo.
English: EU/1/10/648/015 (14 tablets) EU/1/10/648/016 (28 tablets) EU/1/10/648/017 (30 x 1 tablets) EU/1/10/648/018 (56 tablets) EU/1/10/648/019 (90 x 1 tablets) EU/1/10/648/020 (98 tablets) EU/1/10/648/021 (360 (4 x 90 x 1) tablets)
Estonian: EU/1/10/648/015 (14 tabletti) EU/1/10/648/016 (28 tabletti) EU/1/10/648/017 (30 x 1 tabletti) EU/1/10/648/018 (56 tabletti) EU/1/10/648/019 (90 x 1 tabletti) EU/1/10/648/020 (98 tabletti) EU/1/10/648/021 (360 (4 x 90 x 1) tabletti)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/014 (360 (4 x 90 x 1) tablets)
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/10/648/014 (360 (4 x 90 x 1) tabletti)
English: Blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the white layer.
Estonian: Sinine ja valge ovaalse kujuga kahekihilised tabletid, mille valgele kihile on graveeritud toote kood A4 ning firma logo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/021 (360 (4 x 90 x 1) tablets)
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/10/648/021 (360 (4 x 90 x 1) tabletti)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 40 mg/10 mg
Estonian: MINIMAALSED ANDMED, MIS PEAVAD OLEMA BLISTER- VÕI RIBAPAKENDIL 10 tableti blister / 40 mg/10 mg
English: Uncommon abdominal pain, diarrhoea, nausea flatulence
Estonian: Alopeetsia, purpur, nahavärvi muutused, liighigistamine
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 40 mg/5 mg
Estonian: MINIMAALSED ANDMED, MIS PEAVAD OLEMA BLISTER- VÕI RIBAPAKENDIL 10 tableti blister / 40 mg/5 mg
English: Blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the white layer.
Estonian: Sinine ja valge ovaalse kujuga kahekihilised tabletid, mille valgele kihile on graveeritud toote kood A3 ning firma logo.
English: EU/1/10/648/008 (14 tablets) EU/1/10/648/009 (28 tablets) EU/1/10/648/010 (30 x 1 tablets) EU/1/10/648/011 (56 tablets) EU/1/10/648/012 (90 x 1 tablets) EU/1/10/648/013 (98 tablets) EU/1/10/648/014 (360 (4 x 90 x 1) tablets)
Estonian: EU/1/10/648/008 (14 tabletti) EU/1/10/648/009 (28 tabletti) EU/1/10/648/010 (30 x 1 tabletti) EU/1/10/648/011 (56 tabletti) EU/1/10/648/012 (90 x 1 tabletti) EU/1/10/648/013 (98 tabletti) EU/1/10/648/014 (360 (4 x 90 x 1) tabletti)
English: EU/1/10/648/008 (14 tablets) EU/1/10/648/009 (28 tablets) EU/1/10/648/010 (30 x 1 tablets) EU/1/10/648/011 (56 tablets) EU/1/10/648/012 (90 x 1 tablets) EU/1/10/648/013 (98 tablets)
Estonian: EU/1/10/648/008 (14 tabletti) EU/1/10/648/009 (28 tabletti) EU/1/10/648/010 (30 x 1 tabletti) EU/1/10/648/011 (56 tabletti) EU/1/10/648/012 (90 x 1 tabletti) EU/1/10/648/013 (98 tabletti)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 40 mg/10 mg
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 360 MULTIPAKI VAHETU KARP (4 PAKKI 90 x 1 TABLETTI) - ILMA BLUE BOX'ITA / 40 mg/10 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 40 mg/10 mg
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 360 MULTIPAKI VÄLISETIKETT (4 PAKKI 90 x 1 TABLETTI) - SISALDAB BLUE BOX'I / 40 mg/10 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 40 mg/5 mg
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 360 MULTIPAKI VAHETU KARP (4 PAKKI 90 x 1 TABLETTI) - ILMA BLUE BOX'ITA / 40 mg/5 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/028 (360 (4 x 90 x 1) tablets)
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/10/648/028 (360 (4 x 90 x 1) tabletti)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 40 mg/5 mg
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 360 MULTIPAKI VÄLISETIKETT (4 PAKKI 90 x 1 TABLETTI) - SISALDAB BLUE BOX'I / 40 mg/5 mg
English: Blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the white layer.
Estonian: Sinine ja valge ovaalse kujuga kahekihilised tabletid, mille valgele kihile on graveeritud toote kood A2 ning firma logo.
English: feeling sick (nausea), itching, joint pain, muscle cramps, muscle pain, inability to obtain an erection, weakness, chest pain, tiredness, swelling (oedema), increased levels of hepatic enzymes.
Estonian: (hüpotensioon), pearinglus ülestõusmisel (ortostaatiline hüpotensioon), õhetus, köha, kõhuvalu, kõhulahtisus, iiveldus, sügelus, liigesevalu, lihaskrambid, lihasvalu, erektsioonivõimetus, nõrkus, valu rinna piirkonnas, väsimus, paistetus (ödeem), maksaensüümide taseme tõus.
English: LIST OF EXCIPIENTS
Estonian: Erektsioonihäired
English: Paediatric population
Estonian: • Maksahaigus
English: Very rare leukocytopenia, thrombocytopenia
Estonian: Leukotsütopeeniat, trombotsütopeenia
English: The three main studies involved a total of almost 113,000 people.
Estonian: Kolmes põhiuuringus osales kokku ligi 113 000 patsienti.
English: This subunit is not toxic by itself.
Estonian: See alamühik ise ei ole toksiline.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dukoral on 28 April 2004.
Estonian: Euroopa Komisjon andis Dukorali müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 28. aprillil 2004.
English: Once prepared, the suspension should be drunk within two hours.
Estonian: Valmistatud suspensioon tuleb ära juua kahe tunni jooksul.
English: The company also presented data from the published literature.
Estonian: Ettevõte esitas ka teaduskirjanduse andmeid.
English: The course should be completed at least one week before potential exposure to cholera.
Estonian: Ravikuur tuleb viia lõpule vähemalt üks nädal enne võimalikku kokkupuudet kooleraga.
English: The full EPAR for Dukoral can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Dukorali kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The studies took place in areas where cholera is found.
Estonian: Uuringud toimusid piirkondades, kus esineb koolerat.
English: Because Dukoral has been in use in Sweden since 1991, the company presented the results of three main studies that had already been carried out in order to support the use of Dukoral.
Estonian: Et Dukorali on Rootsis kasutatud alates 1991. aastast, esitas ettevõte Dukorali kasutamise toetamiseks kolme varasema põhiuuringu tulemused.
English: The CHMP noted that the risk of cholera for regular tourists is minor, but that Dukoral could be important for certain groups, such as healthcare workers in cholera epidemics.
Estonian: Inimravimikomitee märkis, et tavaliste turistide koolerasse haigestumise oht on väike, kuid Dukoral võib olla tähtis teatud rühmadele, näiteks kooleraepideemia korral tervishoiutöötajatele.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to protect itself against a disease.
Estonian: Vaktsiinid õpetavad immuunsüsteemi (organismi loomulikke kaitsemehhanisme) ennast haiguse eest kaitsma.
English: The granules are dissolved in water and mixed with the vaccine before intake.
Estonian: Graanulid lahustatakse vees ja segatakse enne sissevõtmist vaktsiiniga.
English: Other information about Dukoral:
Estonian: Muu teave Dukorali kohta
English: Dukoral is used in adults, adolescents and children from two years of age who will be visiting high-risk areas.
Estonian: Dukorali kasutatakse täiskasvanutel, noorukitel ja vähemalt 2-aastastel lastel enne suure riskiga piirkondade külastamist.
English: Dukoral cholera vaccine (inactivated, oral)
Estonian: Dukoral kooleravaktsiin (inaktiveeritud, suukaudne)
English: Dukoral should be given according to official recommendations, taking into account where cholera is found and the risk of contracting the disease.
Estonian: Dukorali tuleb manustada ametlike soovituste kohaselt, võttes arvesse koolera levikualasid ja haigusesse nakatumise ohtu.
English: The people in the final study also received a booster dose 10 to 12 months later.
Estonian: Viimases uuringus said patsiendid 10-12 kuud hiljem ka revaktsineerimisannuse.
English: Dukoral should not replace standard protective measures against cholera, including advice on diet and hygiene.
Estonian: Dukoral ei asenda tavapäraseid kooleravastaseid kaitsemeetmeid, sealhulgas toitumise ja hügieeni nõuannete järgimist.
English: Dukoral is used to protect against cholera (a very serious disease caused by V. cholerae, which is caught from contaminated food or water and causes severe diarrhoea).
Estonian: Dukorali kasutatakse vaktsineerimiseks koolera vastu (väga raske haigus, mida põhjustab bakter V. cholerae, millega nakatutakse saastunud toidu või vee kaudu ja mis põhjustab rasket kõhulahtisust).
English: The Committee decided that Dukoral's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Dukorali kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda vaktsiini müügiloa.
English: The first study involved over 89,000 people in Bangladesh and compared Dukoral with the same vaccine without the toxin and with placebo.
Estonian: Esimeses uuringus osales üle 89 000 patsiendi Bangladeshist ning selles võrreldi Dukorali sama vaktsiiniga, milles puudus toksiin, ja platseeboga.
English: What is the risk associated with Dukoral?
Estonian: Mis riskid Dukoraliga kaasnevad?
English: Why has Dukoral been approved?
Estonian: Miks Dukoral heaks kiideti?
English: It is available as a suspension in a bottle together with effervescent granules in a sachet.
Estonian: Seda turustatakse suspensioonina pudelis koos kihisevate graanulite pakikesega.
English: For more information about treatment with Dukoral, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Dukoraliga toimuva vaktsineerimise kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: This document is a summary of the European public assessment report (EPAR) for Dukoral.
Estonian: See on vaktsiini Dukoral Euroopa avaliku hindamisaruande kokkuvõte.
English: Dukoral must not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to formaldehyde.
Estonian: Dukorali ei tohi kasutada patsientidel, kes võivad olla toimeainete, formaaldehüüdi või selle vaktsiini mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: These antibodies will help to protect against cholera by preventing the bacteria and the toxins from attaching to the walls of the gut and entering the body's cells.
Estonian: Need antikehad aitavad kaitsta koolera eest, takistades bakterite ja toksiinide kinnitumist sooleseinale ning sisenemist organismi rakkudesse.
English: In adults, two vaccine doses were shown to be as effective as three.
Estonian: Täiskasvanutel osutus vaktsiini kahe annuse manustamine sama efektiivseks kui kolme annuse kasutamine.
English: However, the following side effects are seen in between 1 and 10 patients in 1,000: headache, diarrhoea, and abdominal (tummy) pain, cramps, gurgling (gas) or discomfort.
Estonian: Kõige sagedamad Dukorali kasutamisel esinenud kõrvalnähud (esinenud 1-10 patsiendil 1000st) on peavalu, kõhulahtisus ja kõhuvalu, krambid, korin (gaasid) või ebamugavustunne.
English: The vaccine contains four different inactivated strains (types) of the bacterium Vibrio cholerae (V. cholerae) serotype O1, and part of a toxin from one of these strains as active substances.
Estonian: Vaktsiin sisaldab toimeainena bakteri Vibrio cholerae (V. cholerae ) serotüübi O1 nelja inaktiveeritud (hävitatud) tüve (tüüpi) ja ühe sellise tüve toksiini osa.
English: The information presented was not sufficient to support the use of Dukoral in traveller's diarrhoea.
Estonian: Esitatud andmetest ei piisanud Dukorali kasutamise toetamiseks reisil esineva kõhulahtisuse korral.
English: The length of protection was different for adults and children, lasting for six months in children and for two years in adults.
Estonian: Vaktsiini kaitsva toime kestus täiskasvanutel ja lastel oli erinev, püsides lastel kuus kuud ja täiskasvanutel kaks aastat.
English: Dukoral is a vaccine.
Estonian: Dukoral on vaktsiin.
English: Children aged between two and six years should receive three doses, with an interval of one to six weeks between each dose.
Estonian: Kahe- kuni kuueaastased lapsed peavad saama kolm annust, jättes iga annuse vahele üks kuni kuus nädalat.
English: What is Dukoral?
Estonian: Mis on Dukoral?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dukoral.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas vaktsiini ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas vaktsiini kasutada.
English: A further study was carried out to show that Dukoral could produce antibodies in people who do not come from areas where cholera is found.
Estonian: Täiendavas uuringus uuriti, kas Dukoral tekitab antikehi patsientidel, kes on pärit piirkonnast, kus koolera puudub.
English: In all three studies, the main measure of effectiveness was the ‘protective effectiveness' of the vaccine, calculated by comparing the number of people in the studies who developed cholera after receiving Dukoral and after receiving placebo.
Estonian: Kõigis kolmes uuringus oli efektiivsuse põhinäitaja vaktsiini kaitse efektiivsus, mille hindamiseks võrreldi pärast Dukorali ja platseebo manustamist koolerasse haigestunud osalejate arvu.
English: When a person is given the vaccine, the immune system recognises the bacteria and the toxin, and makes antibodies against them.
Estonian: Kui patsientidele manustatakse vaktsiini, peab immuunsüsteem baktereid ja toksiini võõrasteks ning tekitab nende vastu antikehi.