FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Protelos, strontium ranelate, acts on the bone structure.
Estonian: Protelose toimeaine strontsiumranelaat mõjub luukoe ehitusele.
English: How is Protelos used?
Estonian: Kuidas Protelost kasutatakse?
English: How does Protelos work?
Estonian: Kuidas Protelost uuriti?
English: How has Protelos been studied?
Estonian: Kuidas Protelos toimib?
English: The medicine can only be obtained with a prescription.
Estonian: Protelos on retseptiravim.
English: These products are not widely authorised in the European Union and therefore availability of data is limited.
Estonian: Nendel ravimitel on Euroopa Liidus müügilube vähe ja seepärast on andmete kättesaadavus piiratud.
English: European Journal of Pediatric Surgery.
Estonian: Pediatric Surgery.
English: Thus, the more intrusive intramuscular injections could be avoided as intravenous administration is seen as a suitable alternative option.
Estonian: Seega saaks vältida sekkuvamaid intramuskulaarseid süste, sest intravenoosset manustamist võib pidada sobivaks alternatiiviks.
English: The mechanism of action is not fully understood.
Estonian: Metamisooli toimemehhanism ei ole täielikult teada.
English: Whilst metamizolecontaining medicinal products were withdrawn in several European countries and also in the USA due to the risk of agranulocytosis, in other countries such as Spain, Poland and Germany, metamizole is frequently used.
Estonian: Kuigi paljudes Euroopa riikides ja USAs on metamisooli sisaldavate ravimite müügiluba agranulotsütoosi riski tõttu tagasi võetud, kasutatakse mitmes riigis, näiteks Hispaanias, Poolas ja Saksamaal, metamisooli sageli.
English: On 26 April 2018, Poland therefore triggered a referral under Article 31 of Directive 2001/83/EC, and requested the CHMP to assess all data available concerning the maximum daily dose and its contraindications on pregnancy and breastfeeding, and issue an opinion as to whether the relevant marketing authorisations should be varied.
Estonian: Sel põhjusel tegi Poola 26. aprillil 2018 direktiivi 2001/83/EÜ artikli 31 kohase esildise ja palus inimravimite komiteel hinnata kõiki kättesaadavaid andmeid maksimaalse ööpäevase annuse ning rasedus- ja imetamisaegsete vastunäidustuste kohta ning koostada arvamus, kas asjaomaseid müügilube tuleb muuta.
English: This single dose can be taken up to 4 times daily at intervals of 6-8 hours.
Estonian: Selle ühekordse annuse tohib võtta kuni 4 korda ööpäevas 6-8 tunni tagant.
English: Besides peripheral inhibition of PG synthesis, central activities have been supposed and documented.
Estonian: Lisaks perifeersele prostaglandiini sünteesi inhibeerimisele on välja pakutud ja dokumenteeritud tsentraalsed toimed.
English: In addition, a general rejection of the use of metamizole for administration in infants below the age of 3 months is not considered to be justified based on the fact that no particular concerns arose from the studies which included patients in this age group.
Estonian: Peale selle ei peetud metamisooli kasutamise üldist keelamist alla 3 kuu vanustel lastel põhjendatuks, sest selle vanuserühma patsiente hõlmanud uuringutes ei ilmnenud erilisi probleeme.
English: The CHMP further noted that two recent studies showed that single intravenous doses of metamizole used for prevention or treatment of postoperative pain were safe in more than 400 infants younger than 1 year (Fieler M et al. 20151, Sümpelmann R et al. 20172).
Estonian: Inimravimite komitee märkis ka, et kaks hiljutist uuringut tõendasid, et metamisooli ühekordne intravenoosne annus kasutamisel operatsioonijärgse valu ennetamisel või ravis oli ohutu rohkem kui 400 alla 1-aastasel imikul (Fieler M et al. 20151, Sümpelmann R et al. 20172).
English: Some data suggest that metamizole and its main metabolite 4-methyl-amino-antipyrine (MAA) may have a combined central and peripheral mechanism of action.
Estonian: On andmeid, mis viitavad, et metamisoolil ja selle peamisel metaboliidil 4-metüülamino-antipüriinil (MAA) võib olla kombineeritud tsentraalne ja perifeerne toimemehhanism.
English: In case of a single administration of metamizole, breastmilk should be discarded for a 48-hour period before breastfeeding can be resumed.
Estonian: Metamisooli ühekordse manustamise järel tuleb rinnapiim 48 tunni jooksul ära visata, enne kui imetamist tohib jätkata.
English: In view of the known risks associated with the use of metamizole, the differences between the product information of metamizole-containing medicines across the EU Member States raise concern.
Estonian: Arvestades teadaolevaid metamisooli kasutamise riske, tekitavad metamisooli sisaldavate ravimite ravimiteabe erinevused Euroopa Liidu liikmesriikides probleeme.
English: However, it is appropriate to allow, if necessary, a parenteral single dose of 2500 mg metamizole and a maximum daily dose of 5000 mg metamizole.
Estonian: Samas võib olla asjakohane ka lubada vajaduse korral metamisooli ühekordset parenteraalset annust 2500 mg ja maksimaalset ööpäevast annust 5000 mg.
English: Current indications for metamizole (as single ingredient) include acute severe pain after trauma or surgery, painful colic, tumour pain, other acute or chronic pain, if other therapeutic measures are contraindicated, and high fever, not responding to other measures.
Estonian: Ainsa toimeainena kasutatava metamisooli praegused näidustused on näiteks äge tugev valu pärast traumat või kirurgilist operatsiooni, valulikud koolikud, kasvajavalu, muu äge või krooniline valu, kui muud ravimeetmed on vastunäidustatud, ja kõrge palavik, mis ei reageeri muule ravile.
English: The Committee also noted that the metabolites of metamizole pass into breastmilk in considerable amounts, and therefore recommended that repeated use of metamizole during breastfeeding should be avoided.
Estonian: Komitee märkis ka, et metamisooli metaboliidid erituvad olulises koguses rinnapiima, ja soovitas seetõttu vältida metamisooli korduvat kasutamist imetamise ajal.
English: Article 31 of Directive 2001/83/EC for metamizole-containing medicinal products
Estonian: • Inimravimite komitee arutas direktiivi 2001/83/EÜ artikli 31 kohast menetlust metamisooli sisaldavate ravimite kohta.
English: Nevertheless, the picture of the mode of action remains incomplete until today.
Estonian: Sellele vaatamata ei ole toimemehhanism seni täielikult teada.
English: No data was available to support a change in posology recommendations for the suppository formulations dosed at 100 mg and 200 mg, as well as for the combination products.
Estonian: Puudusid andmed, mis toetaksid 100 mg ja 200 mg rektaalsuposiidi ning kombinatsioonravimite annustamissoovituste muutmist.
English: • The Committee concluded that the posology recommendations for metamizole-containing medicinal products should be harmonised.
Estonian: • Komitee otsustas, et metamisooli sisaldavate ravimite annustamissoovitused tuleb ühtlustada.
English: In view of the above, the Committee considers that the benefit-risk balance of metamizole-containing medicinal products remains unchanged subject to the agreed amendments to the product information.
Estonian: Seda arvestades on komitee arvamusel, et metamisooli sisaldavate ravimite kasulikkuse ja riski tasakaal jääb samaks, kui ravimiteabes tehakse kokkulepitud muudatused.
English: It is available as monocomponent but also available in several combination products.
Estonian: Seda turustatakse ainuravimina ja mitme kombinatsioonravimina.
English: Poland considered that it is in the interests of the Union to harmonise the information regarding maximum daily dose and contraindications in pregnancy and breastfeeding in the product information of all metamizole-containing medicinal products in the EU.
Estonian: Poola leidis, et liidu huvides on ühtlustada kõigi metamisooli sisaldavate ravimite maksimaalse ööpäevase annuse ning rasedus- ja imetamisaegsete vastunäidustuste teave kogu Euroopa Liidus.
English: The Committee also considered that metamizole containing medicinal products should be contraindicated in the third trimester of pregnancy due to the risks of fetal renal impairment and ductus arteriosus constriction.
Estonian: Samuti leidis komitee, et metamisooli sisaldavad ravimid peavad olema vastunäidustatud raseduse 3. trimestril loote neerukahjustuse ja arterioosjuha ahenemise riski tõttu.
English: An inhibition of prostaglandin (PG) synthesis is known, based on interaction with different cyclooxygenases (COX), resulting in changes in the arachidonic acid metabolism.
Estonian: Teadaolev toime on prostaglandiini sünteesi inhibeerimine, mis põhineb vastastoimel mitme tsüklooksügenaasiga, mis muudab arahhidoonhappe metabolismi.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for metamizole-containing medicinal products.
Estonian: Seega soovitab komitee muuta metamisooli sisaldavate ravimite müügilubade tingimusi.
English: With regards to pregnancy and lactation, although data is limited there is no evidence of teratogenic or embryotoxic effects of metamizole when used during the 1st trimester.
Estonian: Kuigi rasedus- ja imetamisaegse kasutamise andmed on piiratud, puuduvad tõendid metamisooli teratogeensete ja embrüotoksiliste toimete kohta kasutamisel raseduse 1. trimestril.
English: The active substance metamizole (also referred to as dipyrone) is a non-addictive pyrazole-type analgesic, spasmolytic and antipyretic drug with weak anti-inflammatory effects.
Estonian: Toimeaine metamisool (dipüroon) on sõltuvust mittetekitav pürasoolitüüpi analgeetikum, spasmolüütikum ja antipüreetikum, millel on ka nõrk põletikuvastane toime.
English: As a result of this investigation, it was observed that the maximum daily dose of metamizole reflected in the Product Information of the different medicinal products varies from 1,5 g to 6 g. With regards to contraindication in pregnancy and breastfeeding, discrepancies were also noted.
Estonian: Uurimise tulemusena täheldati, et eri ravimite ravimiteabes on metamisooli maksimaalne ööpäevane annus vahemikus 1,5 g…6 g. Leiti ka rasedus- ja imetamisaegsete vastunäidustuste erinevusi.
English: The active substance is contraindicated in pregnancy and breastfeeding in some Member States, while in others it is contraindicated only in the third trimester of pregnancy and breastfeeding; furthermore, in some Member States it is contraindicated in the first and third trimester of pregnancy and breastfeeding.
Estonian: Metamisool on mõnes liikmesriigis raseduse ja imetamise ajal vastunäidustatud, kuid on muudes vastunäidustatud ainult raseduse 3. trimestril ja imetamise ajal.
English: Metamizole has been associated with agranulocytosis and anaphylactic shock.
Estonian: Metamisooli on seostatud agranulotsütoosi ja anafülaktilise šokiga.
English: The recommended oral single dose in adults and adolescents aged 15 years or over is also 500 to 1,000 mg. A single dose can be taken up to 4 times daily at intervals of 6-8 hours leading to a maximum daily dose of 4,000 mg.
Estonian: Soovitatav ühekordne suukaudne annus täiskasvanutel ja vähemalt 15-aastastel noorukitel on samuti 500…1000 mg. Sellise ühekordse annuse tohib võtta kuni 4 korda ööpäevas 6-8 tunni tagant, kuni maksimaalse ööpäevase annuseni 4000 mg.
English: Based on the data assessed, the Committee recommended a parenteral single dose in adults and adolescents aged 15 years or over of 500 - 1,000 mg. A single dose can be taken up to 4 times daily at intervals of 6-8 hours leading to a maximum daily dose of 4,000 mg.
Estonian: Hinnatud andmete alusel soovitas inimravimite komitee parenteraalse ühekordseks annuseks täiskasvanutel ja vähemalt 15-aastastel noorukitel 500…1000 mg. Ühekordset annust tohib võtta kuni 4 korda ööpäevas 6-8 tunni tagant, kuni maksimaalse ööpäevase annuseni 4000 mg.
English: However, there is evidence of fetotoxicity in terms of fetal renal impairment and ductus arteriosus constriction when used in the third trimester and so the Committee considered metamizole should be contraindicated during the third trimester.
Estonian: Samas on tõendeid fetotoksilisuse kohta (loote neerukahjustus ja arterioosjuha ahenemine) kasutamisel raseduse 3. trimestril, mistõttu on komitee arvamusel, et metamisooli kasutamine peab olema 3. trimestril vastunäidustatud.
English: In the frame of a Non Urgent Information (NUI) request, the maximum daily dose and contraindications in pregnancy and breastfeeding were investigated for all metamizole-containing products authorised in European Union (EU).
Estonian: Mitte-kiireloomulise teabe (NUI) taotluse raames uuriti kõigi Euroopa Liidus (EL) müügiloaga metamisooli sisaldavate ravimite maksimaalset ööpäevast annust ning rasedus- ja imetamisaegseid vastunäidustusi.
English: In children and adolescents up to 14 years old, a dose of 8-16 mg metamizole per kg body weight as a single dose is recommended.
Estonian: Lastel ja kuni 14-aastastel noorukitel on soovitatav ühekordne annus 8…16 mg metamisooli kehamassi kg kohta.
English: • The Committee reviewed the totality of the data submitted in relation to the maximum daily dose and the use of metamizole in pregnancy and breastfeeding.
Estonian: • Komitee vaatas läbi kõik esitatud andmed metamisooli maksimaalse ööpäevase annuse ning rasedus- ja imetamisaegse kasutamise kohta.
English: • The Committee considered the identified divergences in the product information of metamizole containing medicinal products, relating to the maximum daily dose and the use of metamizole in pregnancy and breastfeeding.
Estonian: • Komitee arutas tuvastatud erinevusi metamisooli sisaldavate ravimite ravimiteabes seoses metamisooli maksimaalse ööpäevase annuse ning rasedus- ja imetamisaegse kasutamisega.
English: Metamizole is available as tablets (film tablet or dispersible), oral drops, solution for injection, and suppositories.
Estonian: Metamisooli turustatakse tablettidena (õhukese polümeerikattega või dispergeeruvad tabletid), suukaudsete tilkadena, süstelahusena ja rektaalsuposiitidena.
English: Age appropriate formulations (oral drops, solution for injection) are available.
Estonian: Olemas on vanusega kohandatud ravimvormid (suukaudsed tilgad, süstelahus).
English: Try not to breathe through your nose.
Estonian: Püüdke nina kaudu mitte hingata.
English: No specific antidote exists.
Estonian: Spetsiifilist antidooti ei ole.
English: Symptoms are listed in section 4.
Estonian: Sümptomid on loetletud lõigus 4.
English: The ampoule is labelled in English only.
Estonian: Ampulli märgistus on ainult inglise keeles.
English: - Depression or mental health problems.
Estonian: - Depressioon või probleemid vaimse tervisega.
English: Via Martin Luther King, 13 20060 Pessano con Bornago (MI) Italy
Estonian: Via Martin Luther King, 13 20060 Pessano con Bornago (MI) Itaalia
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26/03/2015
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV Müügiloa esmase väljastamise kuupäev: 26/03/2015
English: - A severe allergic reaction.
Estonian: - Raske allergiline reaktsioon.
English: Your doctor will explain more.
Estonian: Teie arst selgitab seda teile põhjalikumalt.
English: Their frequency cannot be estimated from available data.
Estonian: Sagedust ei saa hinnata olemasolevate andmete alusel.
English: Elderly patients (≥ 65 years old)
Estonian: Eakad patsiendid (> 65-aastased)
English: How to use it
Estonian: Kuidas kasutada
English: Some side effects can be serious
Estonian: Mõned kõrvaltoimed võivad olla tõsised.
English: Currently available data are described in sections 4.8, 5.1, 5.2 and 5.3 but no recommendation on a posology can be made.
Estonian: Antud hetkel teadaolevad andmed on esitatud lõikudes 4.8, 5.1 ja 5.2, aga soovitusi annustamise kohta ei ole võimalik anda.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/973/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/14/973/001
English: These findings were more marked in young animals.
Estonian: Need leiud avaldusid selgemalt noorloomadel.
English: c Tested using alpha of 0.05.
Estonian: c Alfa väärtus testimisel 0,05.
English: Once opened, use immediately.
Estonian: Pärast avamist kohe ära kasutada.
English: Other side effects can include:
Estonian: Teiste kõrvaltoimete hulka võivad kuuluda:
English: Elderly patients and women may be more sensitive to QTc-prolonging medicinal products.
Estonian: Eakad patsiendid ja naised võivad olla QTc-d pikendavatele ravimitele tundlikumad.
English: Study 204 (ITT) a
Estonian: Uuring 204 (ITT) a
English: Quinsair should not be given to children and adolescents less than 18 years old as there is not enough information about its use in this age group.
Estonian: Quinsair'i ei tohi anda lastele ega noorukitele vanuses alla 18 eluaasta, kuna selles vanuserühmas kasutamise kohta ei ole piisavalt andmeid.
English: Treatment will restart.
Estonian: Ravi algab uuesti.
English: If the infection is not properly treated it will continue to damage the lungs, causing further problems with breathing.
Estonian: Kui infektsiooni korralikult ei ravita, kahjustab see jätkuvalt kopse, põhjustades seega veelgi rohkem probleeme hingamisega.
English: Stevens-Johnson syndrome,
Estonian: Stevensi-Johnsoni sündroom
English: Repeat cycle
Estonian: Korduv tsükkel
English: Prevention of photosensitisation
Estonian: Fotosensibilisatsiooni ennetamine
English: Before taking this medicine
Estonian: Enne ravimi võtmist
English: How much do I use?
Estonian: Kui palju ma pean kasutama?
English: Results obtained for the primary and key secondary endpoints are provided in Table 2.
Estonian: Esmaste ja olulisemate teiseste tulemusnäitajate andmed on toodud tabelis 2.
English: Quinsair may make your skin become more sensitive to sunlight.
Estonian: Quinsair'i toimel võib teie nahk muutuda päikesevalgusele tundlikumaks.
English: - False test results
Estonian: - Väärad testi tulemused
English: Your doctor may need to give you regular blood tests to check how well your blood can clot.
Estonian: Teie arst võib pidada vajalikuks teile regulaarsete vereanalüüside tegemist, et kontrollida teie vere hüübivust.
English: Tell your doctor or a pharmacist if you are taking, have recently taken or might take any other medicines.
Estonian: Teatage oma arstile või apteekrile, kui te kasutate, olete hiljuti kasutanud või kavatsete kasutada mis tahes muid ravimeid.
English: Hearing loss*
Estonian: Kuulmise kaotus*
English: Dornase alfa;
Estonian: Dornaas alfa
English: Interactions with CYP inhibitors or inducers are thus not expected.
Estonian: Koostoimeid CYP inhibiitorite või indutseerijatega ei ole seega oodata.
English: If this happens to you, do not drive or use any tools or machines.
Estonian: Sel juhul ärge juhtige autot ega kasutage tööriistu või masinaid.
English: If you are diabetic, you should monitor your blood glucose levels carefully.
Estonian: Juhul kui olete diabeetik, peate oma vere glükoosisisaldust hoolikalt jälgima.
English: FEV1 percent predicted
Estonian: FEV1 protsent (prognoositud)
English: Other medicines and Quinsair
Estonian: Muud ravimid ja Quinsair
English: Cyclical therapy may be continued for as long as the physician considers that the patient is obtaining clinical benefit.
Estonian: Tsüklilist ravi võib jätkata senikaua, kuni arsti arvates on patsiendil sellest kliinilist kasu.
English: Important information to know before you start - Each ampoule is for single use only.
Estonian: Teile oluline teave, enne kui raviga alustate - Iga ampull on ainult ühekordseks kasutamiseks.
English: This is because both active substances are capable of blocking the renal tubular secretion of levofloxacin.
Estonian: Seda seetõttu, et mõlemad toimeained võivad blokeerida levofloksatsiini renaalset tubulaarsekretsiooni.
English: 6) When all of the medicine has been delivered, you will hear two ‘beeps', which means the treatment is complete.
Estonian: 6) Kui kogu ravim on manustatud, kuulete kahte helisignaali, mis tähendab, et ravi on lõppenud.
English: The patient should be observed and appropriate hydration maintained.
Estonian: Patsienti tuleb jälgida ning ta peab olema piisavalt hüdreeritud.
English: Each ampoule is for single use only.
Estonian: Iga ampull on ainult ühekordseks kasutamiseks.
English: What if I am using several different inhalers and other therapies for cystic fibrosis?
Estonian: Aga kui ma kasutan mitmeid erinevaid inhalaatoreid ja teisi tsüstilise fibroosi ravimeid?
English: When do I use it?
Estonian: Millal ma pean seda kasutama?
English: The doses should be inhaled as close as possible to 12 hours apart.
Estonian: Annuste inhaleerimiste vahe peaks olema võimalikult täpselt 12 tundi.
English: Press down and turn the cap clockwise as far as it will go (b, Figure 2).
Estonian: Suruge alla ja pöörake korki päripäeva nii kaugele kui võimalik (b, joonis 2).
English: The information that appears on the ampoule is:
Estonian: Ampullil olev teave on järgmine.
English: It may be necessary to confirm positive opiate screens by more specific methods.
Estonian: Opiaatide positiivsete sõeluuringutulemuste kinnitamiseks võib vajalikuks osutuda spetsiifilisemate meetodite kasutamine.
English: Once an ampoule is opened, the contents should be used immediately (see section 6.6).
Estonian: Pärast ampulli avamist tuleb selle sisu kohe ära kasutada (vt lõik 6.6).
English: Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.
Estonian: Vältige mistahes mittevajalikke liigutusi ja pingutust, kuna see võib suurendada kõõluserebendi tekkeriski.
English: Inhaling Quinsair at the same time each day will help you remember when to take your medicine.
Estonian: Quinsair'i inhaleerimine iga päev samal ajal aitab teil ravimi kasutamist meeles pidada.
English: Treatment of these patients with levofloxacin should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment (see also section 4.3).
Estonian: Nendel patsientidel tohib alustada ravi levofloksatsiiniga ainult alternatiivsete ravivõimaluste puudumisel ning pärast hoolikat kasu/riski hindamist (vt ka lõik 4.3).
English: Pharmacotherapeutic group: antibacterials for systemic use, fluoroquinolones ATC code: J01MA12
Estonian: Farmakoterapeutiline rühm: antibakteriaalsed ained süsteemseks kasutamiseks, fluorokinoloonid ATC-kood: J01MA12
English: Inhale this medicine at least 15 minutes or up to 4 hours before your next dose of Quinsair.
Estonian: Inhaleerige seda ravimit vähemalt 15 minutit või kuni 4 tundi enne järgmist Quinsair'i annust.
English: You then start another treatment course.
Estonian: Seejärel alustate uut ravikuuri.
English: 1) Make sure that the Zirela Nebuliser Handset is on a flat and stable surface.
Estonian: 1) Veenduge, et Zirela käsinebulisaator on tasasel ja kindlal pinnal.
English: Other relevant information
Estonian: Muu asjakohane teave
English: Pneumonitis allergic
Estonian: Allergiline pneumoniit
English: Hepatitis*, Hyperbilirubinaemia*
Estonian: Hepatiit* Hüperbilirubineemia*
English: Pivotal Study - Study 209 (Core Phase; ITT)
Estonian: Keskne uuring - uuring 209 (põhifaas, ITT)
English: Prolonged, disabling and potentially irreversible serious adverse drug reactions
Estonian: Ravimi pikaajalised, puuet põhjustavad ja potentsiaalselt pöördumatud tõsised kõrvaltoimed
English: Keep the Zirela Instructions for Use in a safe place as they give full details on assembling the device.
Estonian: Hoidke Zirela kasutusjuhend kindlas kohas, kuna seal on toodud üksikasjalikud juhised seadme kokkupanemiseks.
English: These effects can be attributed to inhibition of topoisomerase II.
Estonian: Neid toimeid saab omistada topoisomeraas II inhibeerimisele.
English: Levofloxacin is stereochemically stable and does not undergo chiral inversion.
Estonian: Levofloksatsiin on stereokeemiliselt stabiilne, kiraalset inversiooni ei toimu.
English: Basic instructions for use are given below.
Estonian: Allpool on toodud üldine kasutusjuhend.
English: How long do I use it for?
Estonian: Kui kaua ma pean seda kasutama?
English: Once an ampoule is opened, the contents should be used immediately.
Estonian: Pärast ampulli avamist tuleb selle sisu kohe ära kasutada.