FrancophonIA/ELRC3.0 huggingface dataset:
English: Instanyl 100 micrograms/dose nasal spray, solution Each ml of solution contains fentanyl citrate equivalent to 1,000 micrograms fentanyl.
Estonian: Instanyl 100 mikrogrammi/annuses ninasprei, lahus 1 ml sisaldab fentanüültsitraati koguses, mis vastab 1000 mikrogrammile fentanüülile.
English: NAME OF THE MEDICINAL PRODUCT Instanyl 50 micrograms/dose nasal spray, solution Fentanyl
Estonian: RAVIMPREPARAADI NIMETUS Instanyl 50 mikrogrammi/annuses ninasprei, lahus Fentanüül
English: - Keep this leaflet.
Estonian: - Tõmmake karbi kaas lahti.
English: Always close after use by putting the child-resistant cap back on to the nasal spray.
Estonian: Pärast kasutamist sulgege ninasprei alati uuesti lastekindla korgiga.
English: Instanyl 200 micrograms/dose nasal spray, solution Each ml of solution contains fentanyl citrate equivalent to 2,000 micrograms fentanyl.
Estonian: Instanyl 200 mikrogrammi/annuses ninasprei, lahus 1 ml sisaldab fentanüültsitraati koguses, mis vastab 2000 mikrogrammile fentanüülile.
English: NAME OF THE MEDICINAL PRODUCT Instanyl 100 micrograms/dose nasal spray, solution Fentanyl
Estonian: RAVIMPREPARAADI NIMETUS Instanyl 100 mikrogrammi/annuses ninasprei, lahus Fentanüül
English: • The pharmacist must be familiar with the educational material of Instanyl nasal spray before using it in his/her organisation.
Estonian: • info, et apteeker peab olema enne Instanyli ninasprei lülitamist oma apteegi ravimite nimekirja olema tutvunud vastava infomaterjaliga;
English: 1.8 ml containing 0.90 mg fentanyl ensuring the delivery of 10 doses of 50 micrograms 2.9 ml containing 1.45 mg fentanyl ensuring the delivery of 20 doses of 50 micrograms 5.0 ml containing 2.50 mg fentanyl ensuring the delivery of 40 doses of 50 micrograms
Estonian: 2,9 ml lahust, mis sisaldab 1,45 mg fentanüüli, mis vastab kahekümnele 50-mikrogrammisele annusele.
English: How to use Instanyl nasal spray
Estonian: Kuidas Instanyli ninaspreid kasutada
English: Fatigue, malaise peripheral oedema, withdrawal syndrome*, neonatal withdrawal syndrome
Estonian: Väsimus, üldine halb enesetunne, perifeersed tursed, võõrutussündroom*, vastsündinu võõrutussündroom
English: Nasal conditions
Estonian: Ninalimaskesta seisundid
English: Also contains: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, water for injections
Estonian: ABIAINED Lisaks sisaldab: naatriumdivesinikfosfaatdihüdraat, dinaatriumfosfaatdihüdraat, süstevesi.
English: Always close after use by puting the child-resistant cap back on to the nasal spray.
Estonian: Pärast kasutamist pange ninasprei alati tagasi lastekindlasse väliskarpi.
English: - Remove the tamper evidence the first time the box is opened - Place a thumb and a middle finger on the side tabs
Estonian: - Asetage pöial ja keskmine sõrm karbi külgedel olevatele lapatsitele.
English: Throat irritation Respiratory depression, epistaxis, nasal ulcer, rhinorrhea
Estonian: Kurguärritus Hingamise pärssumine, ninaverejooks, ninahaavand, rinorröa
English: 1.8 ml containing 1.80 mg fentanyl ensuring the delivery of 10 doses of 100 micrograms 2.9 ml containing 2.90 mg fentanyl ensuring the delivery of 20 doses of 100 micrograms 5.0 ml containing 5.00 mg fentanyl ensuring the delivery of 40 doses of 100 micrograms
Estonian: 1,8 ml lahust, mis sisaldab 0,90 mg fentanüüli, mis vastab kümnele 50-mikrogrammisele annusele.
English: If you experience more than four episodes of breakthrough pain per day, contact your doctor, as your usual cancer pain treatment may have to be changed.
Estonian: Kui ööpäevas esineb rohkem läbilöögivalu episoode, võtke ühendust oma arstiga, sest teie taustavalu ravi võib vajada korrigeerimist.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL / NASAL SPRAY DoseGuard
Estonian: ETIKETT / NINASPREI DoseGuard
English: o Instructions for use of the nasal spray device.
Estonian: INSTANYLI ÜHEANNUSELISE NINASPREI KASUTUSJUHEND
English: What Instanyl looks like and contents of the pack Instanyl is a nasal spray, solution.
Estonian: Kuidas Instanyl välja näeb ja pakendi sisu
English: Special populations
Estonian: Ärajätunähud
English: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 200 micrograms (mcg) fentanyl
Estonian: Üks annus (100 mikroliitrit) sisaldab fentanüültsitraati koguses, mis vastab 200 mikrogrammile (µg) fentanüülile.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Instanyl 50 micrograms/dose nasal spray
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE Instanyl 50 mikrogrammi/annuses ninasprei, lahus Fentanüül
English: Patients should wait 4 hours before treating another breakthrough pain episode with Instanyl during both titration and maintenance therapy.
Estonian: Nii annuse tiitrimise kui ka säilitusravi perioodil võib Instanyli uue läbilöögivalu episoodi raviks kasutada nelja tunni möödudes eelmisest manustamisest.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Instanyl 200 micrograms/dose nasal spray
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE Instanyl 200 mikrogrammi ninasprei Fentanüül
English: 2.0 ml containing 2.00 mg fentanyl ensuring the delivery of 10 doses of 100 micrograms 3.2 ml containing 3.20 mg fentanyl ensuring the delivery of 20 doses of 100 micrograms 4.3 ml containing 4.30 mg fentanyl ensuring the delivery of 30 doses of 100 micrograms 5.3 ml containing 5.30 mg fentanyl ensuring the delivery of 40 doses of 100 micrograms
Estonian: 3,2 ml lahust, mis sisaldab 3,20 mg fentanüüli, mis vastab kahekümnele 100-mikrogrammisele annusele.
English: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 50 micrograms (mcg) fentanyl
Estonian: Üks annus (100 mikroliitrit) sisaldab fentanüültsitraati koguses, mis vastab 50 mikrogrammile (µg) fentanüülile.
English: Instanyl.
Estonian: KÕLBLIKKUSAEG
English: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 100 micrograms (mcg) fentanyl
Estonian: Üks annus (100 mikroliitrit) sisaldab fentanüültsitraati koguses, mis vastab 100 mikrogrammile (µg) fentanüülile.
English: The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, and water for injections.
Estonian: Abiained on naatriumdivesinikfosfaatdihüdraat, dinaatriumfosfaatdihüdraat ja süstevesi.
English: − A training course for neurosurgeons which is aimed at risk minimisation and to support safe and effective use for the product.
Estonian: − neurokirurgide koolitus, mille sihiks on riski minimeerimine ja toote ohutu ja tõhusa kasutuse tagamine.
English: This course shall consist of measures aiming to minimise adverse events associated with the Gliolan-fluorescence-guided surgery (in particular neurological serious adverse events) through adequate education about:
Estonian: Kursus koosneb meetmetest, mille sihiks on minimeerida Gliolani fluorestents-juhitud kirurgiaga seotud kõrvaltoimeid (eriti raskekujulisi neuroloogilisi kõrvaltoimeid) piisava praktilise koolitusega järgmistel teemadel:
English: III trial; - Experience with Gliolan-fluorescence-guided surgery in at least 20 cases.
Estonian: − vähemalt 20 juhtumiga saadud kogemused Gliolani fluorestsents-juhitud kirurgiaga.
English: IV); - Neurophysiological monitoring techniques for surgery in eloquent brain regions.
Estonian: − meeleorganeid kontrollivate ajupiirkondade kirurgias rakendatavad neurofüsioloogilise järelevalve tehnikad.
English: Minimum requirements for a qualified training centre are: - Microscope modified for fluorescence-guided resection; - Sufficient case load (at least 10 patients per year) of malignant gliomas (WHO grade III and
Estonian: − piisav (vähemalt 10 patsienti aastas) pahaloomuliste glioomide (WHO III ja IV staadiumi kasvaja) juhtumite sagedus;
English: Minimum requirements for a qualified trainer are: - Board-certification as neurosurgeon according to local, national requirements; - Previous successful participation at a training course, or equivalent course during the phase
Estonian: − varasem tulemuslik osavõtt koolituskursusest või III faasi uuringu käigus läbitud samaväärsest kursusest;
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ziagen on 8 July 1999.
Estonian: Euroopa Komisjon andis Ziageni müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 8. juulil 1999.
English: Ziagen abacavir
Estonian: Ziagen abakaviir
English: What measures are being taken to ensure the safe and effective use of Ziagen?
Estonian: Mis meetmed võetakse, et tagada Ziageni ohutu ja efektiivne kasutamine?
English: A risk management plan has been developed to ensure that Ziagen is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Ziageni võimalikult ohutu kasutamine.
English: The full EPAR for Ziagen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Ziageni kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is available as tablets (300 mg) and as an oral solution (20 mg/ml).
Estonian: Seda turustatakse tablettidena (300 mg) ja suukaudse lahusena (20 mg/ml).
English: This document is a summary of the European Public Assessment Report (EPAR) for Ziagen.
Estonian: Käesolev dokument on ravimi Ziagen Euroopa avaliku hindamisaruande kokkuvõte.
English: The recommended dose of Ziagen for adults and children weighing at least 25 kg is 600 mg daily.
Estonian: Ziageni soovitatav annus täiskasvanutele ja vähemalt 25 kg kehamassiga lastele on 600 mg ööpäevas.
English: Patients with this gene are at an increased risk of having an allergic reaction to abacavir, so they should not take Ziagen.
Estonian: Patsientidel, kes on selle geeni kandjad, on suurem oht abakaviiriga seotud allergilise reaktsiooni tekkeks, seega ei tohi nad Ziageni võtta.
English: Symptoms almost always include fever or rash, but also very commonly include nausea, vomiting, diarrhoea, abdominal pain (stomach ache), dyspnoea (difficulty breathing), cough, fever, lethargy, malaise (feeling unwell), headache, signs of liver damage in the blood and myalgia (muscle pain).
Estonian: Peaaegu alati on sümptomiteks palavik või lööve, kuid väga sageli ka iiveldus, oksendamine, kõhulahtisus, kõhuvalu, düspnoe (raskendatud hingamine), köha, palavik, loidus, halb enesetunne, peavalu, maksakahjustuste tunnused veres ja lihasevalu.
English: What is Ziagen?
Estonian: Mis on Ziagen?
English: In one of the studies in adults, 77% of the patients taking Ziagen with lamivudine and zidovudine had viral loads below 400 copies/ml after 16 weeks (67 out of 87), compared with 38% of the adults taking lamivudine and zidovudine without Ziagen (33 out of 86).
Estonian: Ühes täiskasvanute uuringus oli patsiente, kellel oli viiruskoormus pärast 16-nädalast ravi alla 400 koopia/ml, Ziageni koos lamivudiini ja sidovudiiniga võtnute rühmas 77% (67 patsienti 87st) ning lamivudiini ja sidovudiini ilma Ziagenita võtnute rühmas 38% (33 patsienti 86st).
English: Patients receiving Ziagen also had increases in their CD4 cell counts.
Estonian: Ziageni võtnud patsientidel suurenes ka CD4-rakkude sisaldus.
English: CD4 T-cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Estonian: CD4-T-rakud on leukotsüüdid (vere valgelibled), mis aitavad nakkuste vastu võidelda, kuid mida HIV hävitab.
English: Why has Ziagen been approved?
Estonian: Miks Ziagen heaks kiideti?
English: Ziagen has also been studied in three main studies including 489 HIV-infected patients aged between three months and 18 years.
Estonian: Ziageni kasutamist uuriti ka kolmes põhiuuringus, milles osales 489 HIV-nakkusega patsienti vanuses 3 kuust 18 aastani.
English: The main measures of effectiveness were the levels of HIV in the blood (viral load) and the number of CD4 T-cells in the blood (CD4 cell count).
Estonian: Efektiivsuse põhinäitajad olid HIV-sisaldus veres (viiruskoormus) ja CD4-T-rakkude sisaldus veres (CD4-rakkude sisaldus).
English: This can be taken either as a single daily dose or divided into 300 mg twice a day.
Estonian: Ööpäevase annuse tohib võtta ühekorraga või jagatuna kaks korda ööpäevas võetavaks 300 mg annuseks.
English: It does not cure HIV infection or AIDS, but it can hold off the damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Estonian: Ziagen ei ravi HIV-nakkust ega AIDS-i välja, kuid võib immuunsüsteemi kahjustumist ning AIDS-iga seotud nakkuste ja haiguste teket edasi lükata.
English: The CHMP noted that the demonstration of the benefit of Ziagen was based on the results of studies mainly carried out with the medicine taken twice a day in combination with other medicines in adults who had not taken HIV treatment before.
Estonian: Komitee märkis, et Ziageni kasulikkust tõendati põhiliselt selliste uuringute tulemustega, milles varem HIV-ravi mittesaanud täiskasvanud patsiendid võtsid ravimit kaks korda ööpäevas koos teiste ravimitega.
English: Ziagen is a medicine that contains the active substance abacavir.
Estonian: Ziagen on ravim, mis sisaldab toimeainena abakaviiri.
English: In addition, the company that markets Ziagen provides educational materials for doctors about hypersensitivity reactions with the medicine, including the need to test patients for the HLA-B (type 5701) gene and to remind patients to contact their doctor immediately if they develop symptoms suggestive of hypersensitivity.
Estonian: Lisaks annab Ziageni turustaja arstidele ravimi ülitundlikkusreaktsioonide kohta teabematerjalid, milles on rõhutatud, et patsientidel tuleb kontrollida geeni HLA-B (tüüp 5701) olemasolu ja et neile tuleb meenutada, et nad pöörduksid ülitundlikkusnähtude ilmnemisel otsekohe arsti poole.
English: In addition, studies were carried out to examine once daily versus twice daily dosing in children.
Estonian: Korraldati ka uuringud, milles võrreldi lastel ööpäevase annuse kasutamist korraga ja kaheks jagatuna.
English: In all of the studies, Ziagen caused a decrease in viral loads, particularly when taken with other antiviral medicines.
Estonian: Kõigis uuringutes vähendas Ziagen viiruskoormust, eelkõige kasutamisel koos teiste viiruseravimitega.
English: For more information about treatment with Ziagen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Ziageniga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
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 Ziagen.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: The most common side effects with Ziagen (seen in between 1 and 10 patients in 100) are loss of appetite, headache, nausea (feeling sick), vomiting, diarrhoea, rash, fever, lethargy (lack of energy) and tiredness.
Estonian: Ziageni kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) on isutus, peavalu, iiveldus, oksendamine, kõhulahtisus, lööve, palavik, loidus ja väsimus.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ziagen, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Ziageni omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Ziagen, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Estonian: Koos teiste viiruseravimitega võetav Ziagen vähendab HIVi kogust veres ja hoiab selle sisalduse väikese.
English: Patients who cannot swallow tablets should use the oral solution, or alternatively they may crush the tablets and add them to a small amount of food or drink immediately before swallowing it. For more information, see the package leaflet.
Estonian: Kui patsiendid ei suuda tablette neelata, tuleb kasutada suukaudset lahust või lisada purustatud tabletid vahetult enne annuse võtmist väikesele söögi- või joogikogusele.
English: In children weighing less than 25 kg the recommended dose depends on body weight.
Estonian: Alla 25 kg kehamassiga laste soovitatav annus oleneb kehamassist.
English: For the full list of all side effects and restrictions with Ziagen, see the package leaflet.
Estonian: Ziageni kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: What is the risk associated with Ziagen?
Estonian: Mis riskid Ziageniga kaasnevad?
English: Hypersensitivity reactions (allergic reactions) occur in patients taking Ziagen, usually within the first six weeks of treatment, and can be life-threatening.
Estonian: Ziageni kasutavatel patsientidel esineb tavaliselt esimese 6 ravinädala jooksul ülitundlikkusreaktsioone (allergiareaktsioone) ja need võivad olla eluohtlikud.
English: Based on its review of the quality, safety and effectiveness of the medicine, the Committee decided that Ziagen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Uuringutulemuste alusel otsustas inimravimite komitee, et Ziageni kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: Other information about Ziagen:
Estonian: Muu teave Ziageni kohta
English: Patients who take Ziagen will also receive an alert card summarising the key safety information on hypersensitivity with the medicine.
Estonian: Samuti saavad Ziageni võtvad patsiendid hoiatuskaardi, milles on ülitundlikkusreaktsiooni kokkuvõtlik ohutusteave.
English: Ziagen is used in combination with other antiviral medicines to treat patients who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Estonian: Ziageni kasutatakse koos teiste viiruseravimitega , et ravida patsiente, kellel on inimese immuunpuudulikkuse viiruse (HIV) nakkus.
English: Ziagen was taken alone, or added to the combination of lamivudine and zidovudine (other antiviral medicines) or the patients' existing HIV treatment.
Estonian: Ziageni kasutati ainsa ravimina või lisaks lamivudiini ja sidovudiini (samuti viiruseravimid) kombinatsioonile või patsientide senisele HIV-ravile.
English: Ziagen's effects were compared with other antiviral medicines, placebo (a dummy treatment) or no treatment.
Estonian: Ziageni võrreldi teiste viiruseravimite, platseebo (näiva ravimi) või ravi puudumisega.
English: Ziagen should be prescribed by a doctor who has experience in the management of HIV infection.
Estonian: Ravi Ziageniga peab määrama HIV-nakkuse ravis kogenud arst.
English: How does Ziagen work?
Estonian: Kuidas Ziagen toimib?
English: The active substance in Ziagen, abacavir, is a nucleoside reverse transcriptase inhibitor (NRTI).
Estonian: Ziageni toimeaine abakaviir on nukleosiidne pöördtranskriptaasi inhibiitor (NRTI), mis blokeerib HIVi tekitatava ensüümi pöördtranskriptaasi.
English: Ziagen has been studied in six main studies including 1,843 HIV-infected adults (aged 18 years and over).
Estonian: Ziageni uuriti kuues põhiuuringus, milles osales 1843 vähemalt 18-aastast HIV-nakkusega täiskasvanut.
English: One study compared the effects of Ziagen taken once and twice a day, in combination with lamivudine and efavirenz (other antiviral medicines) in 784 patients.
Estonian: Ühes uuringus (784 patsienti) võrreldi Ziageni toimet kasutamisel üks ja kaks korda ööpäevas koos lamivudiini ja efavirensiga (samuti viiruseravimid).
English: What is Ziagen used for?
Estonian: Milleks Ziageni kasutatakse?
English: What benefit has Ziagen shown during the studies?
Estonian: Milles seisneb uuringute põhjal Ziageni kasulikkus?
English: It was more effective than placebo, and was as effective as other antiviral medicines in reducing viral loads in all age groups.
Estonian: Ziagen vähendas viiruskoormust kõigis vanuserühmades efektiivsemalt kui platseebo ja sama efektiivselt kui teised viiruseravimid.
English: How is Ziagen used?
Estonian: Kuidas Ziageni kasutatakse?
English: How has Ziagen been studied?
Estonian: Kuidas Ziageni uuriti?
English: Once- and twice-daily Ziagen had similar effects on viral load.
Estonian: Ziageni ööpäevase annuse võtmisel korraga või kaheks jagatuna oli mõju viiruskoormusele sarnane.
English: Treatment with Ziagen should be stopped promptly if the patient has a hypersensitivity reaction.
Estonian: Kui patsiendil tekib ülitundlikkusreaktsioon, tuleb ravi Ziageniga katkestada otsekohe.
English: Teva Ελλάς Α.Ε.
Estonian: Κύπρος Teva Ελλάς Α.Ε., Ελλάδα
English: No new safety concerns were noted during this long-term follow-up.
Estonian: Sellel pikaajalisel jälgimisperioodil ei täheldatud ohutusega
English: The application is based on a reference medicinal product for which no safety concerns requiring additional risk minimisation activities have been identified.
Estonian: Taotlus põhineb referentsravimil, millel ei ole tuvastatud riski minimeerimise lisameetmeid nõudvaid
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Estonian: Müügiloa hoidja peab esitama ravimi perioodilisi ohutusaruandeid juhul, kui ravim on lisatud direktiivi 2001/83/EÜ artikli 107c punktis 7 sätestatud ja Euroopa ravimite veebiportaalis avaldatud liidu kontrollpäevade
English: Some other medicines may influence the use of Clopidogrel ratiopharm or vice versa.
Estonian: Teised ravimid võivad mõjutada Clopidogrel ratiopharm'i kasutamist või vastupidi.
English: Clopidogrel ratiopharm with food and drink Clopidogrel ratiopharm may be taken with or without food.
Estonian: Clopidogrel ratiopharm koos toidu ja joogiga Clopidogrel ratiopharm´it võib võtta koos toiduga või ilma.
English: Detailed information on this medicinal product is available on the website of the European Medicines
Estonian: Täpne teave selle ravimpreparaadii kohta on Euroopa Ravimiameti kodulehel
English: Consequently, a direct effect (slight toxicity), or an indirect effect (low palatability) cannot be
Estonian: Seetõttu ei saa välistada otsest (kerge toksilisus) või kaudset (maitse halvenemine) toimet
English: The recommended dose is one 75 mg tablet of Clopidogrel ratiopharm per day to be taken orally with or without food, and at the same time each day.
Estonian: Soovitatav annus on üks 75 mg Clopidogrel ratiopharm'e tablett päevas suukaudselt koos toiduga või ilma ja iga päev samal kellaajal.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Estonian: Loomkatsed ei näita otsest või kaudset kahjulikku toimet rasedusele, embrüonaalsele/loote arengule, poegimisele ja postnataalsele arengule.