FrancophonIA/ELRC3.0 huggingface dataset:
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).
Estonian: Astreonaami süsteemne kontsentratsioon pärast Caystoni manustamist inhalatsiooni teel on võrreldes astreonaami tavalise süstitava annusega madal (ligikaudu 1% 500 mg astreonaami süstitava annuse kontsentratsioonist).
English: Following administration of aztreonam for injection, aztreonam is excreted in human milk at very low concentrations.
Estonian: Pärast astreonaami süstimist eritub astreonaam rinnapiima väga väikeses kontsentratsioonis.
English: White to off-white powder.
Estonian: Valge või kollakasvalge pulber.
English: Breathe normally (inhale and exhale) through the mouthpiece.
Estonian: Hingake (sisse ja välja) läbi huuliku normaalselt.
English: For inhalation use.
Estonian: Ainult inhalatsiooniks.
English: Replacing the Altera Nebuliser Handset
Estonian: Altera käsinebulisaatori vahetamine
English: After reconstitution the nebuliser solution contains 75 mg aztreonam.
Estonian: Pärast lahustamist sisaldab nebuliseeritav lahus 75 mg astreonaami.
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.
Estonian: Tsüstilise fibroosiga patsientidelt isoleeritud P. aeruginosa tundlikkuse jälgimiseks võib kasutada in vitro bakteriaalse tundlikkuse testimise meetodeid, mida kasutatakse parenteraalses ravis astreonaamiga.
English: After reconstitution, each ml of the nebuliser solution contains 75 mg aztreonam (as lysine).
Estonian: Pärast lahustamist sisaldab 1 ml nebuliseeritavat lahust 75 mg astreonaami (lüsiinina).
English: Cayston 75 mg powder and solvent for nebuliser solution.
Estonian: Cayston 75 mg nebuliseeritava lahuse pulber ja lahusti.
English: injection in rats at daily doses up to 750 mg/kg without adverse effects.
Estonian: Intravenoosselt süstitava astreonaamiga viidi rottidel läbi viljakuse, teratoloogilised ning peri- ja postnataalsed uuringud annustega kuni 750 mg/kg päevas ilma kõrvaltoimete tekkimiseta.
English: Cayston should not be mixed with any other medicinal products in the Altera Nebuliser Handset.
Estonian: Caystonit ei tohi segada Altera käsinebulisaatoris ühegi teise ravimiga.
English: Do not put other medicinal products in the Altera Nebuliser Handset.
Estonian: Ärge kasutage Altera käsinebulisaatoris muid ravimeid.
English: Cayston 75 mg powder for nebuliser solution aztreonam
Estonian: Cayston 75 mg nebuliseeritava lahuse pulber astreonaam
English: or inhaled antipseudomonal antibiotics (84 versus 121, p = 0.004) than TNStreated patients.
Estonian: Lisaks sellele esines respiratoorsetest sündmustest tingitud hospitaliseerimist (40 vs 58, p=0,044) ja intravenoossete või inhaleeritavate antipseudomonaalsete antibiootikumide kasutamist nõudvaid juhte (84 vs 121, p=0,004) astreonaamiga ravitud patsientidel harvem kui TNS-iga ravitud patsientidel.
English: Using the Altera Nebuliser to take your Cayston
Estonian: Altera nebulisaatori kasutamine Caystoni manustamiseks
English: Do not reconstitute more than one dose at a time.
Estonian: Mitte lahustada korraga mitut annust.
English: The development of antibiotic-resistant P. aeruginosa and superinfection with other pathogens represent potential risks associated with antibiotic therapy.
Estonian: Antibiootikumraviga võib kaasneda antibiootikumide suhtes resistentse P. aeruginosa kujunemine ja superinfektsioon muude patogeenidega.
English: - Take Cayston 3 times a day in repeated cycles of 28 days on therapy followed by 28 days off Cayston therapy.
Estonian: - Kasutage Caystonit korratavate tsüklitena, kus 28-päevasele ravikuurile (manustada 3 korda päevas) järgneb 28 Caystoni-ravi vaba päeva.
English: One plastic ampoule of solvent (0.17% w/v sodium chloride).
Estonian: üks plastampull lahustamiseks mõeldud lahusega (0,17 massi-mahuprotsenti naatriumkloriidi).
English: Keep the handset level.
Estonian: Hoidke käsinebulisaatorit jätkuvalt horisontaalselt.
English: Do not mix Cayston with any other medicines in the Altera Nebuliser Handset.
Estonian: Ärge segage Caystonit Altera käsinebulisaatoris teiste ravimitega.
English: It is recommended that Cayston be administered immediately after reconstitution with solvent.
Estonian: Caystonit on soovitatav manustada kohe pärast lahustiga lahustamist.
English: Each powder vial contains 75 mg aztreonam.
Estonian: Pulbriviaal sisaldab 75 mg astreonaami.
English: Sputum concentrations
Estonian: Kontsentratsioon vereplasmas
English: Pyrexia was observed at a higher incidence rate in paediatric patients aged 6 to 17 years compared to adults.
Estonian: Lastel vanuses 6 kuni 17 aastat täheldati püreksia esinemissageduse tõusu võrreldes täiskasvanutega.
English: Over nine 28-day courses of therapy, measures of pulmonary function (FEV1), CFQ-R respiratory symptoms scores, and P. aeruginosa sputum density showed a trend to improvement while the patients were on treatment compared with off treatment.
Estonian: Üheksa 28-päevase ravikuuri järel mõõdeti järgmisi näitajaid: kopsufunktsiooni (FEV1), CFQ-R respiratoorsete sümptomite skoore ja P. aeruginosa sisaldust rögas.
English: Solvent: 1 ml low density polyethylene ampoule.
Estonian: Lahusti: 1 ml madaltihedast polüetüleenist ampull.
English: Powder and solvent for nebuliser solution 42 single-use vials
Estonian: Nebuliseeritava lahuse pulber ja lahusti 42 ühekordselt kasutatavat viaali 44 ühekordselt kasutatavat 1 ml ampulli lahustiga
English: A total of 137 paediatric patients aged 6 to 17 years with chronic P. aeruginosa infection and FEV1 ≤ 75% predicted have received Cayston in Phase 2 and Phase 3 clinical studies.
Estonian: II ja III faasi kliinilistes uuringutes manustati Caystonit 137-le kroonilise P. aeruginosa infektsiooniga lapsele vanuses 6 kuni 17 aastat, kellel oli prognoositav FEV1 ≤75%.
English: The majority of the treatment-emergent isolations were intermittent.
Estonian: Ravist tingitud isoleerimine oli valdavalt hootise iseloomuga.
English: - The powder vial contains 75 mg aztreonam (as lysine).
Estonian: - Pulbriviaal sisaldab 75 mg astreonaami lüsiinina.
English: Pharmacokinetic properties for aztreonam for injection
Estonian: Süstitava astreonaami farmakokineetilised omadused
English: Preparing the Altera Nebuliser to take your Cayston 1.
Estonian: Altera nebulisaatori ettevalmistamine Caystoni manustamiseks
English: - Do not put other medicines in the Altera Nebuliser Handset.
Estonian: - Ärge kasutage Caystoni Altera käsinebulisaatoris muid ravimeid.
English: FEV1 % predicted across 3 treatment courses (the average of the actual change in FEV1 % predicted observed at the end of each treatment course).
Estonian: Esmasteks tulemusnäitajateks olid Caystoni samaväärsus TNS-ga prognoositud FEV1% suhtelise muutuse osas (algväärtusest 28. päevani) ja Caystoni eelis TNS-i ees prognoositud FEV1% tegeliku muutuse osas (algväärtusega võrreldes) kolme ravikuuri lõikes (iga ravikuuri lõpus täheldatud prognoositud FEV1% keskmine tegelik muutus).
English: Bronchospasm (an acute reduction of ≥ 15% in FEV1) is a complication associated with nebulised therapies.
Estonian: Nebuliseeritavate ravimite manustamise üks tüsistus on bronhospasm (järsk FEV1 vähenemine ≥ 15%).
English: A decrease in P. aeruginosa susceptibility to aztreonam and other beta-lactam antibiotics was observed in clinical studies of Cayston.
Estonian: Caystoni kliinilistes uuringutes täheldati P. aeruginosa tundlikkuse vähenemist astreonaami ja muude beetalaktaam-antibiootikumide suhtes.
English: - Do not put the intravenous (injectable) form of aztreonam in the Altera Nebuliser Handset.
Estonian: - Ärge kasutage Altera käsinebulisaatoris intravenoosset (süstitavat) astreonaami.
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.
Estonian: Astreonaami intravenoossel süstimisel eritub muutumatul kujul 60…65% koguannusest.
English: The reconstituted Cayston is then poured into the Altera Nebuliser Handset and the dose administered.
Estonian: Seejärel valatakse valmis Caystoni lahus Altera käsinebulisaatorisse ning manustatakse annus.
English: Haemoptysis
Estonian: Ainevahetus
English: Among patients with multidrug-resistant P. aeruginosa, improvements in respiratory symptoms and pulmonary function were observed following treatment with Cayston.
Estonian: Sellegipoolest ei olnud vähenenud tundlikkus P. aeruginosa'le Caystoni ravi kliinilise efektiivsuse osas uuringuperioodi jooksul määrav.Mitme ravimi suhtes resistentse P. aeruginosa'ga patsientidel paranesid pärast ravi Caystoniga respiratoorsed sümptomid ja kopsude funktsioon.
English: The use of Cayston in paediatric CF patients has been associated with haemoptysis during treatment cycles and could have aggravated underlying conditions.
Estonian: Tsüstilise fibroosiga lastel on Caystonit ravikuuride ajal seostatud hemoptüüsiga ning kaasuva haigusseisundi raskendamisega.
English: After reconstitution, immediate use of Cayston is recommended.
Estonian: Soovitatav on kasutada Cayston ära kohe pärast lahustamist.
English: Powder and solvent for nebuliser solution 84 single-use vials
Estonian: Nebuliseeritava lahuse pulber ja lahusti 84 ühekordselt kasutatavat viaali 88 ühekordselt kasutatavat 1 ml ampulli lahustiga
English: Sodium chloride Water for injections
Estonian: L-lüsiin Lahusti naatriumkloriid süstevesi
English: Caution is advised when administering Cayston to patients if they have a history of beta-lactam allergy.
Estonian: Caystoni manustamisel patsientidele, kellel on esinenud allergiat beetalaktaamide suhtes, peab olema ettevaatlik.
English: Common side effects (affects 1 to 10 users in 100) - Difficulty breathing - Chest discomfort - Runny nose - Coughing up blood - Rash
Estonian: - raskendatud hingamine - ebamugavustunne rinnus - eritis ninast - veriköha - lööve - liigesevalu - kopsufunktsiooni näitajate halvenemine
English: One amber-coloured vial of Cayston with a blue cap.
Estonian: Selleks vajate järgmisi vahendeid: üks merevaikkollane Caystoni viaal koos sinise korgiga.
English: Paediatric population
Estonian: liigeste turse
English: Powder vial and solvent ampoule:
Estonian: Pulbriviaal ja lahustiampull:
English: Gilead Sciences Netherlands B.V. Tel: + 31 (0) 20 718 36 98
Estonian: Tel: + 31 (0) 20 718 36 98
English: Powder and solvent for nebuliser solution.
Estonian: Nebuliseeritava lahuse pulber ja lahusti.
English: whereas MIC90 increased intermittently to 4 times the initial MIC.
Estonian: 24-nädalases aktiivkontrolliga Cayston-ravi uuringus ei täheldatud P.aeruginosa MIK50 (±2 lahjenduse muutust) tõusu, aga MIK90 tõusis kuni 4 korda võrreldes MIK algväärtusega.
English: rash1
Estonian: lööve1
English: Pulmonary function and respiratory symptoms significantly improved from baseline to Day 28 in patients treated with one course of Cayston.
Estonian: Ühe Caystoni ravikuuri läbinud patsientidel olid kopsufunktsiooni näitajad ja hingamisteede sümptomid 28. päeval oluliselt paremad kui uuringut alustades.
English: This summary was last updated in 03-2013.
Estonian: Kokkuvõtte viimane uuendus: 03-2013.
English: Pantoprazole-containing medicines have been available in the European Union (EU) since 1994.
Estonian: Pantoprasooli sisaldavaid ravimeid on Euroopa Liidus müüdud alates 1994. aastast.
English: It is available as gastroresistant tablets (20 mg).
Estonian: Seda turustatakse gastroresistentsete tablettidena (20 mg).
English: Because pantoprazole has been in use for many years, the applicant presented data from the scientific literature.
Estonian: Kuna pantoprasooli on kasutatud palju aastaid, esitas müügiloa taotleja katsetulemused teaduslikust kirjandusest.
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.
Estonian: Euroopa avaliku hindamisaruande täistekst Somac Controli kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Somac Control on 12 June 2009.
Estonian: Euroopa Komisjon andis Somac Controli müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 12. juunil 2009.
English: The tablets should be swallowed whole with liquid before a meal and should not be chewed or crushed.
Estonian: Tabletid tuleb sisse võtta tervelt koos veega enne sööki ja neid ei tohi närida ega purustada.
English: If there is no improvement in symptoms within two weeks of continuous treatment, patients should consult their doctor.
Estonian: Kui sümptomid püsivad pärast 2-nädalast pidevat ravi, peab patsient pöörduma arsti poole.
English: The main measure of effectiveness was the number of patients with symptoms of heartburn over the first two weeks of treatment.
Estonian: Peamine efektiivsusnäitaja oli kõrvetiste sümptomitega patsientide arv kahe esimese ravinädala jooksul.
English: The recommended dose of Somac Control is one tablet once a day until symptoms have stopped.
Estonian: Somac Controli soovitatav annus on üks tablett üks kord päevas kuni sümptomite kadumiseni.
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.
Estonian: Müügiloa taotleja esitas ka andmed, mis saadi kahest põhiuuringust, kus uuriti 20 mg pantoprasooli toimet kokku 563 täiskasvanul, kellel esines refluksisümptomeid, sealhulgas vähemalt üks kõrvetiste episood kolme uuringule eelnenud päeva jooksul.
English: The CHMP therefore decided that Somac Control's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Somac Controli kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: The most common side effects with Somac Control (seen in around 1 patient in 100) are diarrhoea and headache.
Estonian: Somac Controli kõige sagedamad kõrvaltoimed (esinenud enam kui 1 patsiendil 10-st) on kõhulahtisus ja peavalu.
English: It must not be used with atazanavir (a medicine used to treat human immunodeficiency virus [HIV] infection).
Estonian: Ravimit ei tohi kasutada koos atasanaviiriga (ravim, mida kasutatakse inimese immuunpuudulikkuse viiruse (HIV) infektsiooni raviks).
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.
Estonian: Inimravimite komitee märkis, et 20 mg pantoprasool oli refluksisümptomite lühiaegses ravis efektiivne ja et ravimi kasutamisel retseptiravimina on pikaajaline ohutusalane kogemus.
English: Somac Control pantoprazole
Estonian: Somac Control pantoprasool
English: Somac Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients.
Estonian: Somac Controli ei tohi kasutada patsiendid, kes on pantoprasooli, soja või selle ravimi mõne muu koostisaine suhtes ülitundlikud (allergilised).
English: Other information about Somac Control
Estonian: Muu teave Somac Controli kohta
English: Somac Control is used for the short-term treatment of the symptoms of acid reflux in adults.
Estonian: Somac Controli kasutatakse refluksisümptomite lühiajaliseks raviks täiskasvanutel.
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.
Estonian: Esimeses uuringus võrreldi pantoprasooli platseeboga (näiv ravim) 219 täiskasvanul ja teises uuringus ranitidiiniga (teine refluksisümptomite ravim) 344 täiskasvanul.
English: By blocking the pumps, pantoprazole reduces acid production, relieving the symptoms of acid reflux.
Estonian: Prootonpumpade blokeerimisega vähendab pantoprasool maos toodetava happe kogust, leevendades refluksisümptomeid.
English: For more information about treatment with Somac Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Somac Controliga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Somac Control is a medicine that contains the active substance pantoprazole.
Estonian: Somac Control on ravim, mis sisaldab toimeainena pantoprasooli.
English: This is a summary of the European public assessment report (EPAR) for Somac Control.
Estonian: See on ravimi Somac Control Euroopa avaliku hindamisaruande kokkuvõte.
English: Patients should not take the medicine for longer than four weeks without consulting their doctor.
Estonian: Ilma arstiga konsulteerimata ei tohi ravi üle 4 nädala kesta.
English: Acid reflux is when acid produced in the stomach escapes into the gullet, causing heartburn and acid regurgitation (acid flowing up into the mouth).
Estonian: Refluks tähendab maohappe tagasivoolu maost söögitorusse, mis põhjustab kõrvetisi ja happe regurgitatsiooni (haput maitset suus).
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 Somac Control.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: The medicine can be obtained without a prescription.
Estonian: Seda ravimit saab retseptita.
English: The active substance in Somac Control, pantoprazole, is a proton pump inhibitor.
Estonian: Somac Controli toimeaine pantoprasool on prootonpumba inhibiitor.
English: The patient may need to take the medicine for two to three days in a row for symptoms to improve.
Estonian: Sümptomite leevendamiseks võib olla vaja tablette võtta 2-3 järjestikusel päeval.
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.
Estonian: Teises uuringus ei esinenud kaks nädalat pärast ravi alustamist kõrvetisi 70%-l pantoprasooli võtnud patsientidest (121 patsienti 172-st) ja 59%-l ranitidiini võtnud patsientidest (102 patsienti 172-st).
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.
Estonian: Esimeses uuringus ei esinenud kaks nädalat pärast ravi alustamist kõrvetisi 74%-l pantoprasooli võtnud patsientidest (80 patsienti 108-st) ja 43%-l platseebot võtnud patsientidest (48 patsienti 111-st).
English: The reference medicine, Somac, is only available with a prescription.
Estonian: Võrdlusravimit Somaci saab üksnes retsepti alusel.
English: This prevents the active substance from being destroyed by the acid in the stomach.
Estonian: See takistab toimeaine hävinemist maohappe toimel.
English: It is used for long-term treatments and is also used to treat a wider range of gastrointestinal diseases (conditions affecting the gut) than Somac Control.
Estonian: Seda kasutatakse pikaajaliseks raviks ja võrreldes Somac Controliga suurema hulga seedetrakti haiguste (soolehaiguste) raviks.
English: Somac Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Somac.
Estonian: Somac Control on sarnane võrdlusravimiga Somac, millel juba on Euroopa Liidus müügiluba.
English: It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining that pump acid into the stomach.
Estonian: See blokeerib prootonpumbad, mao parietaalrakkudes leiduvad valgud, mis „pumpavad” makku hapet.
English: ‘Gastroresistant' means that the tablet's contents pass through the stomach without being broken down until they reach the intestine.
Estonian: „Gastroresistentne” tähendab, et tablett ei lagune maos, vaid alles sooles.
English: Pantoprazole was more effective than placebo and ranitidine at improving the symptoms of acid reflux.
Estonian: Pantoprasool oli refluksisümptomite leevendamisel efektiivsem kui platseebo ja ranitidiin.
English: It was also of the opinion that, based on the experience of the use of pantoprazole, the availability of
Estonian: Inimravimite komitee oli ka seisukohal, et pantoprasooli kasutamise kogemust arvestades on Somac Controli kättesaadavus ilma arstliku järelevalveta asjakohane.
English: Pantoprazole was also more effective than placebo at reducing symptoms of acid regurgitation.
Estonian: Pantoprasool oli ka happe regurgitatsiooni sümptomite leevendamisel efektiivsem kui platseebo.
English: For the full list of all side effects reported with Somac Control, see the package leaflet.
Estonian: Pantoprasooli kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Why has Somac Control been approved?
Estonian: Miks Somac Control heaks kiideti?
English: What is Somac Control?
Estonian: Mis on Somac Control?
English: What is the risk associated with Somac Control?
Estonian: Mis riskid Somac Controliga kaasnevad?
English: What is Somac Control used for?
Estonian: Milleks Somac Controli kasutatakse?
English: How is Somac Control used?
Estonian: Kuidas Somac Controli kasutatakse?
English: What benefit has Somac Control shown during the studies?
Estonian: Milles seisneb uuringute põhjal Somac Controli kasulikkus?
English: How does Somac Control work?
Estonian: Kuidas Somac Control toimib?
English: How has Somac Control been studied?
Estonian: Kuidas Somac Controli uuriti?
English: What is Diotop?
Estonian: Mis on Diotop?
English: What is the outcome of the review?
Estonian: Mis on ravimiteabe läbivaatamise tulemus?
English: Why was Diotop reviewed?
Estonian: Miks Diotopi ravimiteave uuesti läbi vaadati?
English: The grounds for the referral were concerns raised by Germany that the data provided by the company were not enough to demonstrate the safety and effectiveness of Diotop.
Estonian: Esildise aluseks olid Saksamaa tõstatatud probleemid, et ettevõtte esitatud andmetest ei piisa Diotopi ohutuse ja efektiivsuse tõendamiseks.
English: The review of Diotop was initiated at the request of the United Kingdom, under Article 29(4) of Directive 2001/83/EC.
Estonian: Diotopi ravimiteabe läbivaatamine algas Ühendkuningriigi taotlusel vastavalt direktiivi 2001/83/EÜ artikli 29 lõikele 4.
English: Both diclofenac and omeprazole have been authorised in the EU for many years.
Estonian: Diklofenak ja omeprasool on olnud Euroopa Liidus heaks kiidetud juba aastaid.
English: The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.
Estonian: Ravimiteabe vaatas läbi EMA inimravimite komitee, kes vastutab inimravimitega seotud küsimuste eest.
English: On 15 November 2018, the European Medicines Agency completed a review of Diotop following a disagreement among EU Member States regarding its authorisation.
Estonian: 15. novembril 2018 lõpetas Euroopa Ravimiamet (EMA) Diotopi ravimiteabe läbivaatamise, mille oli põhjustanud Euroopa Liidu liikmesriikide erimeelsus seoses müügiloa andmisega.
English: The two active substances in Diotop have different effects.
Estonian: Diotopi toimeainetel on eri toime.
English: Temmler Pharma GmbH requested that the marketing authorisation for Diotop granted by the UK and Austria in 2016 be recognised in Germany (the ‘concerned Member State').
Estonian: Temler Pharma GmbH soovis, et Saksamaa (asjaomane liikmesriik) tunnustaks Ühendkuningriigis ja Austrias 2016. aastal antud Diotopi müügiluba.