FrancophonIA/ELRC3.0 huggingface dataset:
English: Plasma clearance in patients with hepatic impairment (serum bilirubin between 1.5 and 10 mg/dl) decreased to about 67% when compared with a control group of patients.
Estonian: Plasma kliirens langes maksakahjustusega patsientidel (seerumi bilirubiin 1,5…10 mg/dl) kontrollgrupiga võrreldes umbes 67%-ni. Topotekaani poolväärtusaeg oli umbes 30% võrra pikenenud, kuid jaotusruumala ilmset muutust ei täheldatud.
English: Powder for concentrate for solution for infusion.
Estonian: Infusioonilahuse kontsentraadi pulber.
English: • Feeling sick (nausea), being sick (vomiting); diarrhoea; stomach pain; constipation.
Estonian: • iiveldus, oksendamine, kõhulahtisus; kõhuvalu; kõhukinnisus;
English: • If you get any side effects, talk to your doctor or pharmacist.
Estonian: • Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti või apteekriga.
English: Tell your doctor if any of these applies to you.
Estonian: Kui midagi eelnevast kehtib teie kohta, öelge seda oma arstile.
English: Relapsed SCLC
Estonian: Retsidiveerunud väikerakk-kopsuvähk (SCLC)
English: Anaphylactic reaction, angioedema, urticaria Metabolism and nutrition disorders Very common Anorexia (which may be severe) Respiratory, thoracic and mediastinal disorders Rare
Estonian: Anafülaktiline reaktsioon, angioödeem, urtikaaria Ainevahetus- ja toitumishäired Väga sage
English: Capsule shell Gelatin
Estonian: Kapsli kest Želatiin
English: Median time to onset of moderate to severe anaemia was day 12 with a median duration of 7 days.
Estonian: Mõõdukas või raske aneemia tekkis keskmiselt 12. päeval ja kestis keskmiselt 7 päeva.
English: In addition, elevated hepatic enzymes have been reported with intravenous topotecan overdose.
Estonian: Lisaks on topotekaani intravenoosse üleannustamise korral kirjeldatud maksaensüümide aktiivsuse suurenemist.
English: Pruritus
Estonian: Sügelus
English: Patients with prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Estonian: Eelnevat tsisplatiini kemoradioteraapiat saanud patsiendid Tsisplatiin Topotekaan/tsisplatiin
English: Faecal elimination of total topotecan accounted for 33% while faecal elimination of N-desmethyl topotecan was 1.5%.
Estonian: Roojaga eritus 33 % muutumatul kujul topotekaanina ja 1,5 % N-desmetüültopotekaanina.
English: These may affect more than 1 in 10 people treated with Hycamtin:
Estonian: Need võivad tekkida rohkem kui ühel Hycamtin'iga ravitud inimesel 10-st:
English: Consult your doctor after eye contact or if you experience a skin reaction.
Estonian: Ravimi sattumisel silma või nahareaktsiooni tekkimisel pidage nõu arstiga.
English: Signs include: difficulty breathing cough fever.
Estonian: Nähud on järgmised: hingamisraskus; köha; palavik.
English: HYCAMTIN 1 mg powder for concentrate for solution for infusion HYCAMTIN 4 mg powder for concentrate for solution for infusion
Estonian: HYCAMTIN 1 mg infusioonilahuse kontsentraadi pulber HYCAMTIN 4 mg infusioonilahuse kontsentraadi pulber
English: There is insufficient experience with the use of topotecan in patients with severely impaired hepatic function (serum bilirubin 10 mg/dl) due to cirrhosis.
Estonian: Puudub piisav kogemus topotekaani kasutamisega tsirroosi tagajärjel tekkinud raske maksafunktsiooni kahjustuse (seerumi bilirubiin 10 mg/dl) korral.
English: 5 x 4 mg vials
Estonian: 5 x 4 mg viaali
English: OUTER CARTON
Estonian: VÄLISPAKEND
English: Cisplatin 50 mg/m on day 1 +
Estonian: Tsisplatiin 50 mg/m 1. päeval + Topotekaan 0,75 mg/m 1…3.
English: Sealing band Gelatin
Estonian: Sidusaine Želatiin
English: Hycamtin 0.25 mg hard capsules Hycamtin 1 mg hard capsules topotecan
Estonian: Hycamtin 0,25 mg kõvakapslid Hycamtin 1 mg kõvakapslid topotekaan (Topotecanum)
English: Pancytopenia has been reported.
Estonian: Kirjeldatud on pantsütopeeniat.
English: • Feeling unwell.
Estonian: • halb enesetunne;
English: 9/l, the platelet count is
Estonian: 9/l, trombotsüütide arv
English: 5 x 1 mg vials
Estonian: 5 x 1 mg viaali
English: Moderate thrombocytopenia (Grade 3 - platelets between 10.0 and 50.0 x 10
Estonian: Mõõdukas trombotsütopeenia (3. raskusaste - trombotsüüte 10...50 x 10
English: Thrombocytopenia Severe thrombocytopenia (Grade 4 - platelets <10 x 10
Estonian: Trombotsütopeenia Raske trombotsütopeenia (4. raskusaste - trombotsüüte alla 10 x 10
English: O-glucuronides of both topotecan and N-desmethyl topotecan have been identified in the urine.
Estonian: Nii topotekaani kui N-desmetüültopotekaani O-glükuroniide on leitud uriinis.
English: These may affect up to 1 in 10 people treated with Hycamtin:
Estonian: Need võivad tekkida kuni ühel Hycamtin'iga ravitud inimesel 10-st:
English: HYCAMTIN 0.25 mg hard capsules
Estonian: HYCAMTIN 0,25 mg kõvakapslid
English: These may affect up to 1 in 100 people treated with Hycamtin:
Estonian: Need võivad tekkida kuni ühel Hycamtin'iga ravitud inimesel 100-st:
English: Powder for concentrate for solution for infusion
Estonian: Infusioonilahuse kontsentraadi pulber
English: Mucosal inflammation Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4).
Estonian: Limaskestapõletik Topotekaani kasutanud patsientidel on teatatud sepsisega seotud surmadest (vt lõik 4.4).
English: Keep this medicine out of the sight and reach of children.
Estonian: Kuidas Hycamtin'i säilitada Hoidke seda ravimit laste eest varjatud ja kättesaamatus kohas.
English: Skin and subcutaneous tissue disorders Very common Alopecia Common
Estonian: Hüperbilirubineemia Naha ja nahaaluskoe kahjustused Väga sage
English: HYCAMTIN 1 mg powder for concentrate for solution for infusion topotecan
Estonian: HYCAMTIN 1 mg infusioonilahuse kontsentraadi pulber Topotecanum
English: These may affect up to 1 in 1,000 people treated with Hycamtin:
Estonian: Need võivad tekkida kuni ühel Hycamtin'iga ravitud patsiendil 1000-st:
English: HYCAMTIN 4 mg powder for concentrate for solution for infusion topotecan
Estonian: HYCAMTIN 4 mg infusioonilahuse kontsentraadi pulber Topotecanum
English: Hycamtin 1 mg powder for concentrate for solution for infusion Hycamtin 4 mg powder for concentrate for solution for infusion topotecan
Estonian: Hycamtin 1 mg infusioonilahuse kontsentraadi pulber Hycamtin 4 mg infusioonilahuse kontsentraadi pulber topotekaan (Topotecanum)
English: The clear, reconstituted solution is yellow to yellow-green in colour and provides 1 mg of topotecan per ml.
Estonian: 1 ml kollast kuni kollakasrohelist värvi selget manustamiskõlblikuks muudetud lahust sisaldab 1 mg topotekaani.
English: Rare side effects
Estonian: Harvad kõrvaltoimed
English: Mucosal inflammation
Estonian: Trombotsütopeenia
English: PC:
Estonian: C.
English: Diarrhoea, including severe diarrhoea requiring hospitalisation, has been reported during treatment with oral topotecan.
Estonian: Ravi ajal suukaudse topotekaaniga on tekkinud kõhulahtisus, sealhulgas haiglaravi vajav raske kõhulahtisus.
English: The total content of active substance in the vial provides 1 mg per ml of active substance when reconstituted as recommended (see Package Leaflet).
Estonian: Pärast juhistele vastavat lahustamist (vt pakendi infoleht) on toimeaine sisaldus viaalis 1 mg/ml.
English: Marketing Authorisation Holder Novartis Europharm Limited Vista Building
Estonian: Müügiloa hoidja Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4
English: Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Estonian: Topotekaaniga ravitud patsientidel on kirjeldatud sepsisega lõppenud müelosupressiooni ja sepsisest tingitud surmajuhtumeid (vt lõik 4.8).
English: HYCAMTIN 1 mg powder for concentrate for solution for infusion
Estonian: HYCAMTIN 1 mg infusioonilahuse kontsentraadi pulber
English: HYCAMTIN 4 mg powder for concentrate for solution for infusion
Estonian: HYCAMTIN 4 mg infusioonilahuse kontsentraadi pulber
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
English: Pancytopenia
Estonian: Alopeetsia
English: Patients with renal impairment
Estonian: Maksakahjustusega patsiendid
English: HYCAMTIN 1 mg hard capsules
Estonian: HYCAMTIN 1 mg kõvakapslid
English: Posology
Estonian: Kõvakapslid
English: Gastrointestinal perforation Hepatobiliary disorders Common
Estonian: Seedetrakti perforatsioon Maksa ja sapiteede häired Sage
English: Storage of the prepared solution
Estonian: Valmislahuse säilitamine
English: Check with your doctor or pharmacist if you are not sure.
Estonian: Kui te ei ole milleski kindel, pidage nõu oma arsti või apteekriga.
English: The European Commission granted a marketing authorisation valid throughout the EU for Quadrisol on 4 December 1997.
Estonian: Euroopa Komisjon andis Quadrisoli müügiloa, mis kehtib kogu Euroopa Liidus, 4. detsembril 1997.
English: When used before an operation it is given at least 3 hours before the operation and treatment may be continued for up to one week.
Estonian: Operatsiooni eel kasutamisel antakse ravimit vähemalt 3 tundi enne operatsiooni ja ravi tohib kesta kuni ühe nädala.
English: The full EPAR for Quadrisol can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Quadrisoli kohta on ameti veebilehel: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Quadrisol vedaprofen
Estonian: Quadrisol vedaprofeen
English: The withdrawal period for meat from horses treated with Quadrisol is 12 days.
Estonian: Quadrisoliga ravitud hobuste liha keeluaeg on 12 päeva.
English: This summary was last updated in April 2017.
Estonian: Kokkuvõtte viimane uuendus: 04-2017.
English: It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use.
Estonian: Selles selgitatakse, kuidas amet hindas veterinaarravimit, et soovitada müügiloa andmist Euroopa Liidus ja kasutustingimusi.
English: Quadrisol has been studied in both laboratory and field studies.
Estonian: Quadrisoli uuriti nii labori- kui ka väliuuringutes.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Quadrisol's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Veterinaarravimite komitee järeldas, et Quadrisoli kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: For the full list of restrictions, see the package leaflet.
Estonian: Piirangute täielik loetelu on pakendi infolehel.
English: What is Quadrisol and what is it used for?
Estonian: Mis on Quadrisol ja milleks seda kasutatakse?
English: It is not intended to provide practical advice on how to use Quadrisol.
Estonian: Hindamisaruandes ei anta Quadrisoli kasutamise praktilisi nõuandeid.
English: Why is Quadrisol approved?
Estonian: Miks Quadrisol heaks kiideti?
English: This is a summary of the European public assessment report (EPAR) for Quadrisol.
Estonian: See on ravimi Quadrisol Euroopa avaliku hindamisaruande kokkuvõte.
English: Quadrisol can also be used to relieve pain and reduce inflammation after an operation.
Estonian: Quadrisoli tohib kasutada ka operatsioonijärgse valu leevendamiseks ja põletiku vähendamiseks.
English: Vedaprofen blocks an enzyme called cyclooxygenase which is involved in the production of prostaglandins.
Estonian: Vedaprofeen blokeerib prostaglandiinide tekkimises osaleva ensüümi tsüklooksügenaasi.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Estonian: Juhusliku enesesüstimise korral tuleb pöörduda kohe arsti poole ja näidata talle pakendi infolehte või etiketti.
English: The medicine is not authorised for use in horses producing milk for human consumption.
Estonian: Ravimit ei tohi kasutada hobustel, kelle piima tarvitatakse inimtoiduks.
English: What are the precautions for the person who gives the medicine or comes into contact with the animal?
Estonian: Mis ettevaatusmeetmeid peab võtma loomale ravimit andev või loomaga kokku puutuv inimene?
English: It is also the time required after administration of a medicine before milk may be used for human consumption.
Estonian: See on ka aeg, mis peab ravimi manustamisest mööduma, enne kui piima tohib inimtoiduks tarvitada.
English: Other information about Quadrisol:
Estonian: Muu teave Quadrisoli kohta
English: Side effects are generally reversible once the medicine is stopped.
Estonian: Ravimi manustamise lõpetamisel kõrvalnähud enamasti kaovad.
English: It must not be given to foals aged less than six months or to mares producing milk.
Estonian: Seda ei tohi anda alla 6-kuustele varssadele ja lakteerivatele märadele.
English: What are the risks associated with Quadrisol?
Estonian: Mis riskid Quadrisoliga kaasnevad?
English: For practical information about using Quadrisol, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Estonian: Kui loomaomanikud või -pidajad vajavad Quadrisoli kasutamise praktilisi nõuandeid, peavad nad lugema pakendi infolehte või pöörduma oma veterinaararsti või apteekri poole.
English: In horses, skin rashes (urticaria) have been reported.
Estonian: Hobustel on teatatud ka lööbe (urtikaaria) esinemisest.
English: The side effects of Quadrisol are typical for those seen with other medicines from this product class (NSAIDs) such as lethargy or damage to (lesions) the mouth, stomach, intestines (including soft stools or diarrhoea) and kidneys.
Estonian: Quadrisoli kõrvalnähud on sarnased selle ravimiklassi (NSAID-ravimid) kõrvalnähtudega, nt letargia või suu-, mao-, soolekahjustused (sh pehme väljaheide või kõhulahtisus) ja neerukahjustused.
English: It contains the active substance vedaprofen.
Estonian: Ravim sisaldab toimeainena vedaprofeeni.
English: This included studies in a large number of horses with bone, muscle and other soft tissue and joint problems.
Estonian: Uuringutes uuriti suurt arvu luu-, lihaste, pehmekudede ja liigeseprobleemidega hobuseid.
English: The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.
Estonian: Keeluaeg on alates ravimi manustamisest arvestatav aeg, mille jooksul ei tohi looma tappa ega tema liha inimtoiduks tarvitada.
English: Quadrisol contains vedaprofen, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Estonian: Quadrisol sisaldab vedaprofeeni, mis kuulub mittesteroidsete põletikuvastaste ravimite klassi.
English: How does Quadrisol work?
Estonian: Kuidas Quadrisol toimib?
English: How is Quadrisol used?
Estonian: Kuidas Quadrisoli kasutatakse?
English: Quadrisol oral gel improved lameness and soft tissue injuries in horses and the response to treatment with Quadrisol was similar to the response to either flunixine meglumine or phenylbutazone, which are other NSAIDs used to treat these conditions.
Estonian: Quadrisoli suukaudne geel parandas lonkamist ja pehmekudede vigastusi hobustel, selle ravivastus oli sarnane fluniksiniinmeglumiini ja fenüülbutasooni (nende haigusseisundite ravimiseks kasutatavad teised NSAID-ravimid) ravivastustega.
English: Quadrisol, available as an oral (mouth) gel, is given twice daily before feeding for a maximum of two weeks.
Estonian: Seda manustatakse kuni kahe nädala jooksul kaks korda ööpäevas enne söötmist.
English: What benefits of Quadrisol have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Quadrisoli kasulikkus?
English: Quadrisol must not be given to horses with stomach and gut disorders or to horses with reduced heart, liver and kidney function.
Estonian: Quadrisoli ei tohi anda mao- ja soolehäirete ning südame-, maksa- ja neerutalitluse vaegusega hobustele.
English: Quadrisol is a veterinary medicine used in horses to relieve pain and reduce inflammation due to injury to the muscle, bones and joints as well as to other non-bony areas of the body (so called soft tissue lesions).
Estonian: Quadrisol on veterinaarravim, mida kasutatakse hobustel valu leevendamiseks ja lihaste, luude, liigeste ja pehmekudede vigastuste tõttu tekkinud põletiku vähendamiseks.
English: As prostaglandins are substances that trigger inflammation, pain, and fever, vedaprofen reduces these signs of injury.
Estonian: Prostaglandiinid tekitavad põletikku, valu ja palavikku tekitavad ained.
English: The amount of gel given in each dose is adjusted depending on the weight of the animal.
Estonian: Manustatav geelikogus kohandatakse looma kehamassile.
English: o Is not favourable in all other currently approved indications.
Estonian: o ei ole soodne teistel praegu heakskiidetud näidustustel;
English: However new cases of cardiotoxicity continued to be reported.
Estonian: Sellest hoolimata teatati jätkuvalt uutest kardiotoksilisuse juhtudest.
English: However it is important that this be confirmed in an appropriate pharmacokinetic study.
Estonian: Siiski on oluline seda asjakohase farmakokineetilise uuringuga kinnitada.
English: However, it is not expected that the mechanism of action will differ between adults and children, and there is in some Member States long-lasting clinical experience with this product in children.
Estonian: Samas ei eeldata, et toimemehhanism erineb täiskasvanutel ja lastel ning mõnes liikmesriigis on pikaajaline kliiniline kogemus selle ravimi kasutamisega lastel.
English: As a consequence, the intravenous formulation was withdrawn worldwide.
Estonian: Selle tulemusena võeti intravenoosne ravimvorm kogu maailmas tagasi.
English: Therefore some of the high dose formulations can no longer be recommended.
Estonian: Seetõttu ei saa mõningaid suure annusega ravimvorme enam soovitada;
English: A formulation for intravenous (IV) administration was discontinued in 1985.
Estonian: Intravenoosse (IV) ravimvormi manustamine lõpetati 1985. aastal.
English: • Nausea and vomiting of functional, organic, infectious or dietetic origin
Estonian: • funktsionaalse, orgaanilise päritoluga, nakkusest või toitumisest põhjustatud iiveldus ja oksendamine,
English: Domperidone is commonly used across Europe since 1970s when it was first time authorized via national procedures.
Estonian: Domperidooni kasutatakse Euroopas laialdaselt alates 1970. aastatest, mil see sai riiklike menetluste kaudu esmakordselt müügiloa.
English: • dopamine agonists (such as L-dopa and bromocriptine) used in the treatment of Parkinson's disease
Estonian: • dopamiini agonistid (näiteks L-dopa ja bromokriptiin), mida kasutatakse Parkinsoni tõve ravis.
English: Minor amendments were also introduced in the Product Information for clarity.
Estonian: Ravimiteabesse lisati ka väiksemaid selgitavaid muudatusi.
English: In October 2011 the PhVWP agreed on amendments to the product information, and the Marketing Authorisation Holder of the originator product was requested to conduct a pharmacoepidemiological study and a thorough QTc study.
Estonian: 2011. aasta oktoobris nõustus ravimiohutuse järelevalve töörühm ravimiteabesse tehtavate muudatustega ning originaalravimi müügiloa hoidjal paluti teha farmakoepidemioloogiline uuring ja põhjalik QTc uuring.
English: • radiotherapy or drug therapy
Estonian: • kiiritusravi või ravimravi;
English: these circumstances patients should not be exposed to the additional risk associated to a combination product.
Estonian: Neid asjaolusid arvestades ei tohiks patsientidele tekitada kombineeritud ravimiga täiendavat riski.
English: It is therefore important that the risk is minimised by restricting the maximum dose (10 mg up to 3 times a day for adults and adolescents 12 years of age and older and weighing ≥ 35 kg), limiting treatment duration to the shortest necessary to control symptoms and contraindicating other drugs that are also known to prolong the QT-interval.
Estonian: Seetõttu on oluline riske minimeerida, piirates suurimat annust (10 mg kuni kolm korda ööpäevas täiskasvanutel ja vähemalt 12-aastastel ning ≥ 35 kg kaaluvatel lastel), piirates ravi kestust sümptomite leevendamiseks vajaliku lühima ajaga ning välistades teised ravimid, mis teadaolevalt samuti pikendavad QT-intervalli.
English: Domperidone is not approved in all Member States for paediatric use in the subpopulation under 12 years of age and adolescents weighing <35 kg.
Estonian: Domperidoon ei ole kõigis liikmesriikides alla 12-aastaste ja vähem kui 35 kg kaaluvate laste alarühmas pediaatriliseks kasutamiseks heaks kiidetud.
English: In view of the cardiac risk, off-label use should be monitored.
Estonian: Arvestades südamega seotud ohte, tuleks ravimi kasutamist muul kui kõnealusel näidustusel jälgida.
English: The International Birth Date for domperidone has been designated as March 1978, based on the first approval of domperidone in Belgium.
Estonian: Domperidooni rahvusvaheliseks sünnipäevaks peetakse 1978. aasta märtsi, mil domperidoon kiideti esimest korda Belgias heaks.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC for domperidonecontaining medicinal products.
Estonian: • ravimiohutuse riskihindamiskomitee kasutas domperidooni sisaldavate ravimite hindamiseks direktiivi 2001/83/EÜ artikli 31 kohast menetlust;
English: In light of the above, on 01 March 2013 Belgium informed the European Medicines Agency, pursuant to Article 31 of Directive 2001/83/EC, of their decision to trigger an Art. 31 referral procedure to ask for the PRAC's recommendation on whether the balance of benefits and risks for these products is still positive in the approved indications, and whether the marketing authorisations for medicinal products containing domperidone should be maintained, varied, suspended or withdrawn.
Estonian: Eespool öeldut arvestades teavitas Belgia 1. märtsil 2013 direktiivi 2001/83/EÜ artikli 31 alusel Euroopa Ravimiametit oma otsusest algatada artikli 31 kohane esildismenetlus, et küsida ravimiohutuse riskihindamiskomitee soovitust selle kohta, kas nende ravimite kasulikkuse ja riski suhe on heakskiidetud näidustustel endiselt positiivne ja kas domperidooni sisaldavate ravimite müügiload tuleks säilitada, muuta, peatada või tagasi võtta.
English: • Nausea and vomiting induced by:
Estonian: • iiveldus ja oksendamine, mida põhjustavad
English: Whenever available, paediatric patients should make use of other formulations that allow for more accurate dosing (e.g. oral solution) and these should be supplied with an appropriate measuring device.
Estonian: Kui vähegi võimalik, tuleks lastel kasutada teisi ravimvorme, mis võimaldavad täpsemat annustamist (nt suukaudne lahus), ja nendega peaks olema kaasas sobiv mõõtmisvahend.
English: Overall summary of the scientific evaluation by PRAC
Estonian: Ravimiohutuse riskihindamiskomitee teostatud teadusliku hindamise üldkokkuvõte
English: • The PRAC considered that the risk of serious cardiac adverse drug reactions can be minimised by using lower doses of domperidone, limiting treatment duration and contraindicating treatment for patients at particularly high risk (patients with moderate or severe hepatic impairment, patients who have known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure) and patients concurrently taking QT-prolonging drugs or potent CYP3A4 inhibitors.
Estonian: • ravimiohutuse riskihindamiskomitee leidis, et ravimi tõsiste südamega seotud kõrvalnähtude riski saab minimeerida, kasutades domperidooni väiksemaid annuseid, piirates ravi kestust ja välistades ravi eriti suure riskiga patsientidel (mõõduka või raske maksapuudulikkusega patsiendid; patsiendid, kellel on teadaolevalt pikenenud südame erutusjuhte intervallid, eelkõige QTc; elektrolüütide oluliste tasakaaluhäirete või südamehaiguse, näiteks südame paispuudulikkusega patsiendid) ja patsiendid, kes võtavad samal ajal QT-intervalli pikendavaid ravimeid või tugevaid CYP3A4 inhibiitoreid.