FrancophonIA/ELRC3.0 huggingface dataset:
English: Sumatriptan Galpharm was intended to be similar to a ‘reference medicine' already authorised in the European Union called Imigran.
Estonian: Sumatriptan Galpharm pidi olema sarnane võrdlusravimiga Imigran, millel juba on Euroopa Liidus müügiluba.
English: Refusal of the marketing authorisation for Sumatriptan Galpharm 50 mg tablets
Estonian: Sumatriptan Galpharm 50 mg tablettide müügiloa andmisest keeldumine
English: The company presented the results of a study carried out to investigate whether it is ‘bioequivalent' to the reference medicine and data in support of its use in the non-prescription setting.
Estonian: Ettevõte esitas uuringu tulemused, mille eesmärgiks oli näidata Sumatriptan Galpharmi bioekvivalentsust võrdlusravimiga Imigran, ja andmed, mis toetasid preparaadi kasutamist käsimüügiravimina.
English: What were the CHMP's main concerns that led to the refusal?
Estonian: Mis olid peamised probleemid, mille tõttu soovitas inimravimite komitee müügiloa andmisest keelduda?
English: This will stop the symptoms of migraine: headache, sickness and sensitivity to light.
Estonian: Sumatriptaan aitab veresoontel taas aheneda, mis peatab migreenisümptomid, nagu peavalu, iivelduse ja valgustundlikkuse.
English: Sumatriptan Galpharm was expected to work in the same way as the reference medicine, Imigran.
Estonian: Sumatriptan Galpharmi eeldatav toime on samasugune nagu võrdlusravimil Imigran.
English: Sumatriptan Galpharm was expected to be used to relieve migraine attacks in people who had been diagnosed with migraine.
Estonian: Sumatriptan Galpharmi kavatseti kasutada migreeniepisoodide leevendamiseks inimestel, kellel on diagnoositud migreen.
English: How is Sumatriptan Galpharm expected to work?
Estonian: Milline on Sumatriptan Galpharmi eeldatav toime?
English: This was because a lack of medical supervision and monitoring of the patient would increase the risk for cerebrovascular (brain) and cardiovascular (heart) side effects and potential misuse and overuse.
Estonian: 2011. aasta juulis leidis inimravimite komitee, et Sumatriptan Galpharmi kasutamist käsimüügiravimina ei ole võimalik heaks kiita, eelkõige põhjusel, et patsiendi meditsiinilise järelevalve ja jälgimise puudumine suurendab aju- ja südameveresoonkonna kõrvalnähtude ning ravimi väär- ja liigkasutamise riski.
English: This summary was last updated in 03-2015.
Estonian: Kokkuvõtte viimane uuendus: 03-2015.
English: FEV1 is the most air a person can breathe out in one second.
Estonian: FEV1 on suurim õhumaht, mida inimene suudab ühe sekundi jooksul välja hingata.
English: The tablets should be swallowed with water at the same time each day.
Estonian: Tabletid tuleb koos veega alla neelata iga päev samal kellaajal.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Daliresp on 28 February 2011.
Estonian: Euroopa Komisjon andis Dalirespi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 28. veebruaril 2011.
English: It is available as tablets (500 micrograms).
Estonian: Seda turustatakse tablettidena (500 µg).
English: The company is also carrying out an observational study on the long-term safety of the medicine.
Estonian: Ka korraldab ettevõte ravimi pikaajalise ohutuse tõendamise uuringu.
English: What measures are being taken to ensure the safe and effective use of Daliresp?
Estonian: Mis meetmed võetakse, et tagada Dalirespi ohutu ja efektiivne kasutamine?
English: A risk management plan has been developed to ensure that Daliresp is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Dalirespi võimalikult ohutu kasutamine.
English: The full EPAR for Daliresp can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Dalirespi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This authorisation was based on the authorisation granted to Daxas in 2010 (‘informed consent').
Estonian: Müügiluba põhineb 2010. aastal antud Daxase müügiloal (teabel põhineva nõusoleku alusel).
English: This benefit was seen on top of the effects of the treatments that the patients were already receiving.
Estonian: Kasulikkus ilmnes lisaks nende ravimite toimele, mida patsiendid juba said.
English: At the beginning of the study, both groups of patients had an FEV1 of around 1 litre (1,000 ml).
Estonian: Uuringu alguses oli mõlema rühma patsientide FEV1 ligikaudu 1 liiter (1000 ml).
English: The doctor may stop treatment with Daliresp if the patient loses too much weight.
Estonian: Arst võib lõpetada Dalirespiga toimuva ravi, kui patsiendi kaalukaotus on liiga suur.
English: After considering all of the available data on the effects of the medicine, the Committee decided that Daliresp's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Olles kaalunud kõiki kättesaadavaid andmeid ravimi toime kohta, otsustas komitee, et Dalirespi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: The recommended dose of Daliresp is one tablet once a day.
Estonian: Dalirespi soovitatav annus on üks tablett üks kord ööpäevas.
English: Because patients taking Daliresp may lose weight, they are advised to weigh themselves on a regular basis.
Estonian: Et Dalirespi võtvate patsientide kehakaal võib väheneda, soovitatakse neil end regulaarselt kaaluda.
English: Daliresp must not be used in patients who have moderate or severe problems with their liver.
Estonian: Dalirespi ei tohi kasutada mõõdukate või raskete maksaprobleemidega patsiendid.
English: The company will also provide cards for patients, telling them what information that they need to give their doctor about their symptoms and past illnesses to help the doctor know whether Daliresp is appropriate for them.
Estonian: Samuti annab ettevõte patsientidele teabekaardid, kus selgitatakse, mis sümptomitest ja varasematest haigustest peavad patsiendid arstile teatama, et arst oskaks otsustada, kas Daliresp sobib neile.
English: Daliresp is a medicine that contains the active substance roflumilast.
Estonian: Daliresp on ravim, mis sisaldab toimeainena roflumilasti.
English: This is a summary of the European public assessment report (EPAR) for Daliresp.
Estonian: See on ravimi Daliresp Euroopa avaliku hindamisaruande kokkuvõte.
English: The patients could continue to receive treatment with a bronchodilator during the study.
Estonian: Uuringu ajal võisid patsiendid jätkata ravi bronhodilataatoriga.
English: The most common side effects with Daliresp (seen in between 1 and 10 patients in 100) are decreased weight, decreased appetite, insomnia (difficulty sleeping), headache, diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache).
Estonian: Dalirespi kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) on kehakaalu vähenemine, isutus, unetus, peavalu, kõhulahtisus, iiveldus ja kõhuvalu.
English: Why has Daliresp been approved?
Estonian: Miks Daliresp heaks kiideti?
English: What is Daliresp?
Estonian: Mis on Daliresp?
English: The active substance in Daliresp, roflumilast, belongs to a group of medicines called ‘phosphodiesterase type 4 (PDE4) inhibitors'.
Estonian: Dalirespi toimeaine roflumilast kuulub fosfodiesteraas-4 (PDE4) inhibiitorite ravimirühma.
English: For more information about treatment with Daliresp, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Dalirespiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Patients may need to take Daliresp for several weeks before it starts to have an effect.
Estonian: Daliresp võib hakata mõjuma alles mitme nädala pärast.
English: After a year, the patients who took Daliresp had an average increase of 40 ml while those given placebo had an average decrease of 9 ml.
Estonian: Aasta pärast oli Dalirespi võtnud patsientidel FEV1 suurenenud keskmiselt 40 ml, platseebot võtnud patsientidel aga vähenenud keskmiselt 9 ml.
English: Other information about Daliresp
Estonian: Muu teave Dalirespi kohta
English: Daliresp has been compared with placebo (a dummy treatment) in two main studies involving over 3,000 adults with severe COPD who had had at least one flare-up of their disease in the past year.
Estonian: Dalirespi võrreldi platseeboga (näiv ravim) kahes põhiuuringus, kus osales üle 3000 raske kroonilise obstruktiivse kopsuhaigusega täiskasvanu, kelle haigus oli viimase aasta jooksul vähemalt ühe korra ägenenud.
English: The main measure of effectiveness was the improvement in forced expiratory volumes (FEV1) and the reduction in the number of moderate or severe flare-ups of their COPD over a year of treatment.
Estonian: Efektiivsuse põhinäitaja oli forsseeritud ekspiratoorse mahu (FEV1) suurenemine ning mõõdukate ja raskete kopsuhaiguse ägenemiste arvu vähenemine aastase ravi jooksul.
English: The CHMP noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Daliresp in patients with severe COPD.
Estonian: Inimravimite komitee märkis, et vajadus uute kroonilise obstruktiivse kopsuhaiguse ravimite järele on olemas ja et põhiuuringud näitasid Dalirespi tagasihoidlikku kasulikkust raske kopsuhaigusega patsientide ravis.
English: In addition, the company that makes Daliresp will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine's side effects and how it should be used.
Estonian: Dalirespi tootja tagab ka, et ravimit määravad kõigi Euroopa Liidu liikmesriikide meditsiinitöötajad saavad ravimi kõrvalnähtude ja kasutamise teabematerjalid.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Daliresp, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Dalirespi omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Daliresp is not used on its own but as an ‘add-on' to treatment with bronchodilators (medicines that widen the airways in the lungs).
Estonian: Dalirespi kasutatakse ainult lisaks ravile bronhodilataatoritega (ravimid, mis laiendavad hingamisteid).
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 Daliresp.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: By blocking the action of PDE4, roflumilast reduces the inflammation in the lungs, helping to reduce the patient's symptoms or to prevent them from getting worse.
Estonian: Roflumilast blokeerib kroonilist obstruktiivset kopsuhaigust põhjustavas põletikuprotsessis osaleva ensüümi PDE4 toime, vähendades nii põletikku kopsudes ning aidates patsiendi sümptomeid vähendada või takistada nende süvenemist.
English: Daliresp is used to treat severe chronic obstructive pulmonary disease (COPD) in adults who have chronic bronchitis (long-term inflammation of the airways), and whose COPD flares up frequently.
Estonian: Dalirespi kasutatakse kroonilise bronhiidina (pikaajaline hingamisteede põletik) avalduva raske kroonilise obstruktiivse kopsuhaiguse raviks täiskasvanutel, kelle haigus sageli ägeneb.
English: How does Daliresp work?
Estonian: Kuidas Daliresp toimib?
English: What is the risk associated with Daliresp?
Estonian: Mis riskid Dalirespiga kaasnevad?
English: For the full list of all side effects reported with Daliresp, see the package leaflet.
Estonian: Dalirespi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: In addition, the patients who took Daliresp had an average of 1.1 moderate or severe flare-ups of their disease, compared with 1.4 flare-ups in the patients who took placebo.
Estonian: Haiguse mõõdukaid ja raskeid ägenemisi esines Dalirespi võtnud patsientidel keskmiselt 1,1 korda ja platseebot võtnud patsientidel 1,4 korda.
English: The card will include an area where patients can record their weight.
Estonian: Kaardil on ka koht, kuhu patsient saab kirjutada oma kehakaalu ja kaalumise kuupäevad.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing air in and out of the lungs.
Estonian: Krooniline obstruktiivne kopsuhaigus on krooniline haigus, mis kahjustab või ummistab hingamisteid ja kopsualveoole ning raskendab sisse- ja väljahingamist.
English: What benefit has Daliresp shown during the studies?
Estonian: Milles seisneb uuringute põhjal Dalirespi kasulikkus?
English: What is Daliresp used for?
Estonian: Milleks Dalirespi kasutatakse?
English: Daliresp was shown to be more effective than placebo at treating COPD.
Estonian: Uuringud näitasid, et Daliresp on kroonilise obstruktiivse kopsuhaiguse ravis efektiivsem kui platseebo.
English: How is Daliresp used?
Estonian: Kuidas Dalirespi kasutatakse?
English: How has Daliresp been studied?
Estonian: Kuidas Dalirespi uuriti?
English: These side effects occurred in more than 1 in 4 patients.
Estonian: Neid kõrvalnähte esines enam kui 1 patsiendil 4st.
English: Further information on Braftovi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave Braftovi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Braftovi (encorafenib)
Estonian: Braftovi (enkorafeniib)
English: What measures are being taken to ensure the safe and effective use of Braftovi?
Estonian: Mis meetmed võetakse, et tagada Braftovi ohutu ja efektiivne kasutamine?
English: Braftovi is available as capsules (50 mg and 75 mg).
Estonian: Braftovit turustatakse kapslitena (50 mg ja 75 mg).
English: Braftovi (encorafenib) EMA/570410/2018
Estonian: Braftovi (enkorafeniib) EMA/570410/2018
English: The European Medicines Agency therefore decided that Braftovi's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Braftovi kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: For the full list of side effects and restrictions, see the package leaflet.
Estonian: Kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: As for all medicines, data on the use of Braftovi are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Braftovi kasutamise kohta pidevat järelevalvet.
English: Patients normally take 450 mg (six 75 mg capsules) once a day but can have the dose reduced or treatment stopped temporarily if they experience troublesome side effects.
Estonian: Tavaliselt võtavad patsiendid 450 mg (kuus 75 mg kapslit) kord ööpäevas, kuid häirivate kõrvalnähtude tekkimisel on võimalik annust vähendada või ravi ajutiselt peatada.
English: Other information about Braftovi
Estonian: Muu teave Braftovi kohta
English: The side effects seen with Braftovi are similar to those seen with other medicines in the same class and are considered manageable.
Estonian: Braftoviga täheldatud kõrvalnähud sarnanevad teiste sama klassi ravimite kõrvalnähtudega ning neid peetakse hallatavateks.
English: What is Braftovi and what is it used for?
Estonian: Mis on Braftovi ja milleks seda kasutatakse?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Braftovi have been included in the summary of product characteristics and the package leaflet.
Estonian: Braftovi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: The dose of the other medicine, binimetinib, may also be reduced but if binimetinib is stopped Braftovi must be stopped too.
Estonian: Teise ravimi, binimetiniibi annust võib olla samuti vaja vähendada, kuid binimetiniibravi lõpetamisel tuleb lõpetada ka Braftovi-ravi.
English: For more information about using Braftovi, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Braftovi kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: This encourages cancers to develop by allowing uncontrolled division of cells.
Estonian: See soodustab vähi teket, võimaldades kasvajarakkudel piiramatult jaguneda.
English: Side effects reported with Braftovi are carefully evaluated and any necessary action taken to protect patients.
Estonian: Braftovi kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Treatment with Braftovi can last for as long as the patient is benefiting from it and does not have unacceptable side effects.
Estonian: Ravi Braftoviga tohib jätkata seni, kuni see on patsiendile kasulik ja tal ei ole tekkinud vastuvõetamatuid kõrvalnähte.
English: The most common side effects with Braftovi and binimetinib taken together at the highest recommended doses are tiredness, nausea (feeling sick), diarrhoea, vomiting, retinal detachment (an eye problem that leads to poor vision), abdominal pain, joint pain, muscle pain and high levels of an enzyme called creatine kinase, which may indicate muscle problems.
Estonian: Braftovi kõige sagedamad kõrvalnähud kasutatuna koos binimetiniibiga kõige suuremates soovitatavates annustes on väsimus, iiveldus, kõhulahtisus, oksendamine, võrkkestairre (silmaprobleem, mis põhjustab nägemishäireid), kõhuvalu, liigesevalu, lihasevalu ja kreatiinkinaasi (teatav ensüüm) suur sisaldus, mis võib viidata lihaseprobleemidele.
English: Patients who took this combination lived on average for nearly 15 months without the disease getting worse.
Estonian: Seda kombinatsiooni kasutanud patsientide keskmine progresseerumiseta elumus oli peaaegu 15 kuud.
English: What are the risks associated with Braftovi?
Estonian: Mis riskid Braftoviga kaasnevad?
English: Up to 50% of patients with metastatic melanoma have a mutation in BRAF with the V600 mutation being the most common.
Estonian: Kuni 50%-l metastaatilise melanoomiga patsientidest on BRAF-valgu mutatsioon, kusjuures kõige levinum mutatsioon on V600.
English: Braftovi is used in combination with another medicine, binimetinib (Mektovi), and is only for patients whose cancer cells have a specific mutation (change) in their genes called 'BRAF V600'.
Estonian: Braftovit kasutatakse koos teise ravimi, binimetiniibiga (Mektovi) ning see on ette nähtud üksnes patsientidele, kelle vähirakkudes on teatud geenimutatsioon (muutus) - BRAF V600.
English: A study of 577 patients with melanoma with the BRAF V600 mutation that had spread or could not be removed surgically showed that Braftovi with binimetinib can prolong the length of time patients lived without their disease getting worse.
Estonian: Uuringus, milles osales 577 patsienti, kellel oli metastaatiline või kirurgiliselt eemaldamatu BRAF V600 mutatsiooniga melanoom, tõendati, et Braftovi koos binimetiniibiga võib pikendada patsientide progresseerumiseta elumust (kui kaua patsiendid elavad ilma haiguse süvenemiseta).
English: It contains the active substance encorafenib.
Estonian: Ravim sisaldab toimeainena enkorafeniibi.
English: Braftovi is a medicine for treating melanoma (a skin cancer) that has spread or cannot be removed by surgery.
Estonian: Braftovi on ravim, mida kasutatakse melanoomi (teatud liiki nahavähi) raviks, kui vähk on metastaatiline või seda ei saa kirurgiliselt eemaldada.
English: The active substance in Braftovi, encorafenib, works by blocking the BRAF protein thereby stopping its activation by MEK and slowing down the growth and spread of the cancer.
Estonian: Braftovi toimeaine enkorafeniib blokeerib BRAF-valgu ja takistab seeläbi MEK-valgul seda aktiveerimast, aeglustades nii vähi kasvu ja levikut.
English: This compared with over 9.5 months for patients who took encorafenib alone and just over 7 months for patients taking a different medicine called vemurafenib.
Estonian: Ainult enkorafeniibi kasutanud patsientidel oli see enam kui 9,5 kuud ja teist ravimit, vemurafeniibi kasutanud patsientidel pisut üle 7 kuu.
English: Braftovi in combination with binimetinib can help prolong the time that these patients live without their disease getting worse.
Estonian: Braftovi koos binimetiniibiga võib aidata pikendada nende patsientide progresseerumiseta elumust.
English: How is Braftovi used?
Estonian: Kuidas Braftovit kasutatakse?
English: Braftovi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in prescribing cancer medicines.
Estonian: Ravi peab alustama ja jälgima vähiravimite määramises kogenud arst.
English: How does Braftovi work?
Estonian: Kuidas Braftovi toimib?
English: In melanoma tumours with the BRAF V600 mutation, an abnormal form of the protein BRAF is present, which switches on another protein called MEK involved in stimulating cell division.
Estonian: BRAF V600 mutatsiooniga melanoomkasvajates esineb BRAF-valgu ebanormaalne vorm, mis aktiveerib rakkude jagunemise stimuleerimises osaleva MEK-valgu.
English: What benefits of Braftovi have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Braftovi kasulikkus?
English: An overview of Braftovi and why it is authorised in the EU
Estonian: Ülevaade ravimist Braftovi ja ELis müügiloa väljastamise põhjendus
English: ATCvet code: QC09BA07.
Estonian: ATCvet-kood: QC09BA07.
English: DATE OF REVISION OF THE TEXT
Estonian: TEKSTI ÜLEVAATAMISE KUUPÄEV
English: Date of first authorisation: 23/07/2012 Date of latest renewal:
Estonian: Esmase müügiloa väljastamise kuupäev: 23/07/2012 Müügiloa viimase uuendamise kuupäev:
English: Très le Bois
Estonian: Tres le Bois
English: Each chewable tablet contains:
Estonian: Iga närimistablett sisaldab:
English: Manufacturers responsible for batch release: Ceva Santé Animale
Estonian: Partii vabastamise eest vastutavad tootjad: Ceva Santé Animale
English: Steady-state conditions are reached by day 2.
Estonian: Püsikontsentratsiooni tingimused saavutatakse teiseks päevaks.
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Estonian: Küsige palun oma loomaarstilt või apteekrilt, kuidas hävitatakse ravimeid, mida enam ei vajata.
English: Wash hands after use.
Estonian: Pärast kasutamist peske käsi.
English: The bottles are fitted with childproof caps.
Estonian: Pudelid on varustatud lastekindlate korkidega.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Estonian: Üksikasjalikku teavet antud veterinaarravimi kohta leiab Euroopa Ravimiameti koduleheküljelt http://www.ema.europa.eu
English: 4.8 Interaction with other medicinal products and other forms of interaction
Estonian: 4.8 Koostoimed teiste ravimitega ja teised koostoimed
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Estonian: Kui täheldate tõsiseid kõrvaltoimeid või muid toimeid, mida pole käesolevas pakendi infolehes mainitud, või arvate, et veterinaarravim ei toimi, teavitage sellest oma veterinaararsti.
English: Vomiting has been reported very rarely in spontaneous reports.
Estonian: Spontaansetes teadetes on väga harva teatatud oksendamisest.
English: 22600 Loudéac
Estonian: 22600 Loudeac
English: Do not use in dogs intended or used for breeding.
Estonian: Mitte kasutada aretamiseks mõeldud või kasutatavatel koertel.
English: Do not use during pregnancy and lactation (see section 4.7).
Estonian: Mitte kasutada tiinuse ja imetamise ajal (vt punkt 4.7).