FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant use of ritonavir may also induce the liver enzymes with a similar negative effect on contraceptive efficacy.
Estonian: Ka ritonaviir võib maksaensüüme aktiveerida ning omada analoogset mõju rasestumisvastasele toimele.
English: Lactation may be influenced by COCs as they may reduce the amount and change the composition of human milk.
Estonian: Kombineeritud suukaudsed kontratseptiivid võivad avaldada mõju imetamisele, vähendades rinnapiima kogust ja muutes selle koostist.
English: Ocular Lesions
Estonian: Silmakahjustused
English: Oral contraception.
Estonian: Suukaudne kontratseptsioon.
English: 1.Circulatory disorders
Estonian: Menstruatsioonitsükli häired
English: Hyperlipidaemic women should be closely monitored if they choose to use contraceptive pills.
Estonian: Kui hüperlipideemiaga naised valivad kontratseptsiooniks suukaudsed rasestumisvastased tabletid,
English: Ethinylestradiol undergoes presystemic conjugation both in the small intestinal mucosa and in the liver.
Estonian: Etinüülöstradiool läbib presüsteemse konjugatsiooni nii peensoole limaskestas kui ka maksas.
English: Coated tablet
Estonian: Kaetud tablett.
English: If the patient does not have a withdrawal bleed at the end of the second pack, she must return to her doctor to exclude the possibility of pregnancy.
Estonian: Kui kasutajal ei teki teise pakendi lõpus vaheveritsust, tuleb enne tablettide võtmise jätkamist välistada rasedus.
English: Thrombosis in other blood vessels has very rarely been reported, i.e. hepatic, mesenteric, renal or retinal veins and arteries, in users of oral contraceptives.
Estonian: Teistes veresoontes, st maksa, soolekinnisti, neeru või silma võrkkesta arterites ja veenides, on pillide kasutajatel tromboosi teket kirjeldatud väga harva.
English: (ratio 1:1)
Estonian: (VAATA I LISA)
English: Benign and malignant liver tumours have been reported in users of combined oral contraceptives.
Estonian: Kombineeritud suukaudsete kontratseptiivide kasutajatel on teatatud nii hea- kui ka pahaloomulistest kasvajatest.
English: Drug interactions resulting in an increased clearance of sexual hormones may lead to break through bleeding and contraceptive failure.
Estonian: Suguhormoonide kliirensit suurendavate ravimite koostoimed võivad viia vaheveritsuste tekkeni ja vähendada kontratseptsiooni tõhusust.
English: − Previous prodromal symptoms of thrombosis (e.g. transient cerebral ischaemia, angina pectoris)
Estonian: Varasemad tromboosi eelnähud (nt transitoorne ajuisheemia, stenokardia).
English: Note: This SPC is the one that was Annexed to the Commission Decision on this Article 29 referral for levonogestrel and ethinylestradiol containing medicinal products.
Estonian: Levongestreel ja etinüülöstradiool sisaldavaid ravimeid puudutava esildise kohta tehtud komisjoni otsuse lisa.
English: Seven days of uninterrupted tablet taking is required to maintain adequate suppression of the hypothalamus-pituitary-ovarian-axis.
Estonian: Selleks, et saavutada hüpotaalamuse-käbikeha-munasarjade telje piisav suppressioon, on vaja tablette võtta katkestusteta vähemalt seitse päeva.
English: Pharmacokinetic properties Levonorgestrel
Estonian: 0.150 mg levonorgestreeli
English: The excretion of conjugates of ethinylestradiol and its metabolites takes place via urine and faeces.
Estonian: Etinüülöstradiooli ja selle metaboliitide konjugaadid erituvad uriini ja väljaheitega (suhtes 1:1).
English: COCs generally exhibit wide variation with regard to pharmacokinetics.
Estonian: Kombineeritud oraalsetel kontratseptiividel esineb hulgaliselt erinevaid farmakokineetilisi toimeid.
English: In this case, she should keep a tablet-free interval of up to 7 days, including the days she forgot to take her tablets, and thereafter continue with the next blister pack.
Estonian: mil ta unustas tableti võtmata, ja see järel jätkama uue blisterpakendiga.
English: Preclinical data based on conventional studies of repeated dose toxicity, genotoxicity and carcinogenic potential revealed no particular human risks beyond those discussed in other sections of the SPC.
Estonian: Kroonilise toksilisuse, genotoksilisuse ja kartsinogeensuse prekliinilised uuringud ei ole näidanud kahjulikku toimet inimesele, va ravimi omaduste kokkuvõtte eespool olevates lõikudes käsitletud riskid.
English: The use of contraceptive steroids may have an influence on the results of certain laboratory tests, including biochemical parameters for liver, thyroid, adrenal and renal function; on the plasma levels for (transport)proteins, e.g. corticosteroid-binding globulin and lipid/lipoprotein fractions; on parameters for carbohydrate metabolism and parameters for coagulation and fibrinolysis.
Estonian: (transpordi)valkude, nagu näiteks kortikoseteroide siduva globuliini ja lipiidide/lipoproteiinide fraktsioone; süsivesikute ainevahetuse näitajaid ja koagulatsiooni ning fibrinolüüsi näitajaid.
English: Levonorgestrel displayed a virilising effect in female fetuses.
Estonian: Levongestreel avaldas emasloodetele viriliseerivat toimet.
English: Other medical conditions which have been related to circulatory disorders, include diabetes mellitus, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or colitis ulcerosa) and sickle cell anaemia.
Estonian: hemolüütilis-ureemiline sündroom, kroonilised soolte põletikulised haigused (Crohni tõbi ja haavandiline koliit) ning sirprakuline aneemia.
English: Changing from a progestogen-only method (progestogen-only or mini-pills, injection, implant) The woman may switch from progestogen-only pills on any day (from an implant on the day the implant is removed or from injection, when the next injection should have been given).
Estonian: Ainult progestiini sisaldavalt preparaadilt võib minna üle suvalisel päeval (implantaadi puhul päevast,
English: Core:
Estonian: Kate:
English: During the extension the woman may experience break through bleeding or spotting.
Estonian: Pillide pikaajalisel järjestikusel kasutusel võib tekkida vaheveritsus või verega määrimine.
English: Estimated cumulative numbers of breast cancers per 10,000 women diagnosed in 5 years of use and up to 10 years after stopping COCs, compared with numbers of breast cancers diagnosed in 10,000 women who had never used COCs
Estonian: diagnoosituna 5-aastase kasutuse ajal ja 10 aasta möödudes COC-de kasutusest.
English: After delivery or abortion in 2nd trimester
Estonian: Pärast sünnitust või aborti teisel trimestril Teavet imetavate naiste kohta vt lõik 4.6.
English: A liver tumour must be taken into consideration as a differential diagnosis when severe pain occurs in the upper abdomen, if there is hepatomegaly, or if there are signs of intra-abdominal haemorrhage in women taking oral contraceptives.
Estonian: Hepatomegaaliaga ägeda ülakõhuvaluga või intraabdominaalse verejooksu nähtudega pille võtval naisel tuleb diferentsiaaldiagnoosis arvestada maksakasvaja võimalusega.
English: sucrose talc calcium carbonate titanium dioxide (E171)
Estonian: titaandioksiid (E171), kopovidoon K90, makrogool 6000,
English: In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors the woman should be advised to contact her physician.
Estonian: Naist tuleb juhendada arsti poole pöörduma, kui ükski neist seisunditest või riskiteguritest peaks süvenema, ägenema või esmakordselt ilmnema.
English: ⇒ Despite wide inter- and intra-individual variations of steroid plasma concentrations, high contraceptive efficacy is consistently demonstrated in COC's with 0.030 mg ethinylestradiol and 0150 mg levonorgestrel, ⇒ There is a poor correlation between plasma steroid levels and contraceptive efficacy, ⇒ The pharmacokinetics of progestogens and EE do not adequately reflect safety parameters, such as endometrial bleeding or common adverse events nor rare effects such as risk of thromboembolic disease,
Estonian: Hoolimata suurtest erinevustest konkreetse indiviidi ning indiviididevahelistes steroidide plasmakontsentratsioonides, on KOKi hea rasestumisvastane toime pidevalt kinnitust saanud preparaatide puhul, mis sisaldavad 0,030 mg etinüülöstradiooli ja 0,150 mg levonorgestreeli.
English: Venous thromboembolism (VTE), manifesting itself as deep venous thrombosis and/or pulmonary embolic disorder, may occur with any oral contraceptive.
Estonian: Ükskõik millise kombineeritud suukaudse kontratseptiivi kasutamisega võib tekkida venoosne trombemboolia (VTE), mis võib väljenduda süvaveeni tromboosi ja/või kopsuembooliana.
English: Metabolism:
Estonian: Ainevahetus:
English: Furthermore, high contraceptive efficacy has been demonstrated with lower doses in marketed products than those found in Rigevidon and high contraceptive efficacy has also been shown for progestogenonly methods with considerably lower doses than those found in COCs.
Estonian: Samuti on tõestust leidnud ainult progesterooni sisaldavate ravimite hea rasestumist ärahoidev toime ja seda võrreldes kombineeritud oraalsetes kontratseptiivides sisalduvaga märkimisväärselt madalamate annuste puhul.
English: The treatment must cease if symptoms indicating imminent complications occur: serious abnormal headache, visual disturbances, increased blood pressure, clinical signs of deep venous thrombosis or pulmonary embolic disorders.
Estonian: nägemishäired, tõusnud vererõhk, süvaveenitromboosi ja kopsuemboolia kliinilised nähud.
English: Hydrolysis of the direct conjugates of ethinylestradiol by the intestinal flora gives ethinylestradiol,
Estonian: Soolestiku mikrofloora poolt etinüülöstradiooli otseste konjugaatide hüdrolüüsi tulemusel tekib etinüülöstradiool, mis võib tagasiimenduda ja läbida seega enterohepaatilise vereringe.
English: − Ocular disorder of vascular origin
Estonian: Vaskulaarsed silmahaigused.
English: Coating:
Estonian: Kasvajad:
English: − arterial thromboembolic disorders (in particular myocardial infarction, cerebrovascular disorder)
Estonian: Arteriaalne trombemboolia või selle olemasolu anamneesis, eelkõige müokardiinfarkt,
English: − Arterial thromboembolism or medical history of arterial thromboembolism, in particular myocardial infarction, cerebrovascular disorder (see section 4.4)
Estonian: arteriaalne tromboemboolia (eelkõige müokardiinfarkt, ajuveresoonkonna häire); venoosne trombemboolia (flebiit, kopsuemboolia); arteriaalne hüpertensioon, pärgarterite haigused;
English: 4.7 Effects on ability to drive and use machines
Estonian: Kasutamis- ja käsitsemisjuhend
English: Hence, the use of oral contraceptives cannot generally be recommended until the lactating mother has completely weaned off the child. Small amounts of contraceptive steroids and/or their metabolites may be excreted with the milk.
Estonian: Kontratseptiivsed steroidid ja/või nende metaboliidid võivad väikeses koguses imenduda rinnapiima.
English: There have been case reports of retinal thrombosis with the use of oral contraceptives.
Estonian: Suukaudsete kontatseptiivide võtjatel on teatatud silma võrkkesta tromboosi tekkest.
English: If pregnancy occurs during medication with Rigevidon,
Estonian: Kui Rigevidoni võttes patsient rasestub, tuleb pillide võtmine koheselt lõpetada.
English: The contraceptive effect of Rigevidon is based on the interaction between various factors, the most important of which are the inhibition of ovulation and changes in the cervical mucus.
Estonian: Neist olulisim on ovulatsiooni pärssimine ja emakakaelalima muutused.
English: Crohn's disease and colitis ulcerosa have been associated with the use of combined oral contraceptives.
Estonian: Kombineeritud suukaudsete kontatseptiividega on seostatud Crohni tõve ja haavandilise koliidi teket.
English: − Venous thromboembolism or medical history of venous thromboembolism (deep venous thrombosis, pulmonary embolism) with or without risk factors (see section 4.4)
Estonian: Venoosne trombemboolia või selle olemasolu anamneesis (süvaveenide tromboos, kopsuemboolia)
English: - Age.
Estonian: talk,
English: The herbal preparation St John's wort (Hypericum perforatum) should not be taken concomitantly with this medicine as this could potentially lead to a loss of contraceptive effect.
Estonian: Pillidega samaaegselt ei tohi võtta naistepuna (Hypericum perforatum) sisaldavaid taimseid preparaate,
English: − Migraine with focal neurological symptoms − Hypersensitivity to the active substances or to any of the excipients
Estonian: Ülitundlikkus toimeaine või ravimi ükskõik millise abiaine suhtes.
English: − Malignant tumours in the breast
Estonian: Rinnanäärme pahaloomulised kasvajad.
English: Dzuveo should not be used for more than 48 hours.
Estonian: Dzuveot ei tohi kasutada kauem kui 48 tundi.
English: What measures are being taken to ensure the safe and effective use of Dzuveo?
Estonian: Mis meetmed võetakse, et tagada Dzuveo ohutu ja efektiivne kasutamine?
English: Further information on Dzuveo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave Dzuveo kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Dzuveo (sufentanil)
Estonian: Dzuveo (sufentaniil)
English: Other information about Dzuveo
Estonian: Muu teave Dzuveo kohta
English: Dzuveo (sufentanil) EMA/283761/2018
Estonian: Dzuveo (sufentaniil) EMA/283761/2018
English: The European Medicines Agency therefore decided that Dzuveo's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Dzuveo kasulikkus on suurem kui sellega kaasnevad riskid, ja lubati ravimi kasutamine ELis.
English: It should be given by a healthcare professional experienced in treating pain and in a place (such as a hospital) where the patient can be monitored.
Estonian: Seda peab patsiendile andma valuravis kogenud tervishoiutöötaja kohas, kus patsienti on võimalik jälgida (näiteks haiglas).
English: As for all medicines, data on the use of Dzuveo are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Dzuveo kasutamise kohta pidevat järelevalvet.
English: What is Dzuveo and what is it used for?
Estonian: Mis on Dzuveo ja milleks seda kasutatakse?
English: The most common side effects (which may affect more than 1 in 10 people) are nausea, vomiting and fever.
Estonian: Dzuveo kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on iiveldus, oksendamine ja palavik.
English: The tablet must not be chewed or swallowed.
Estonian: Tabletti ei tohi närida ega alla neelata.
English: Dzuveo must not be used in patients with serious lung or breathing problems.
Estonian: Dzuveot ei tohi kasutada raskete kopsu- või hingamisprobleemidega patsiendid.
English: The most serious side effects with sufentanil are severe breathing problems, which occur in around 6 people in 1,000.
Estonian: Sufentaniili kõige raskemad kõrvalnähud on rasked hingamisprobleemid, mis esinevad ligikaudu 6 patsiendil 1000st.
English: This means that it is similar to a ‘reference medicine' (called Sufenta Forte) containing the same active substance.
Estonian: See tähendab, et see on sarnane sama toimeainet sisaldava võrdlusravimiga (Sufenta Forte).
English: Using a disposable applicator, the healthcare professional should place one tablet under the patient's tongue and leave it to dissolve.
Estonian: Tervishoiutöötaja peab ühekorraaplikaatoriga asetama ühe tableti patsiendi keele alla ja laskma sel lahustuda.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dzuveo have been included in the summary of product characteristics and the package leaflet.
Estonian: Dzuveo ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Both studies used a pain rating scale known as SPID12 which tracks reduction in pain over 12 hours.
Estonian: Mõlemas uuringus hinnati valu tugevust SPID12-skaalal, millega jälgitakse valu vähenemist 12 tunni jooksul.
English: For more information about using Dzuveo, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Dzuveo kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Dzuveo contains the active substance sufentanil.
Estonian: Dzuveo sisaldab toimeainena sufentaniili.
English: Side effects reported with Dzuveo are carefully evaluated and any necessary action taken to protect patients.
Estonian: Dzuveo kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Dzuveo is an opioid pain medicine used to treat moderate to severe pain in adults.
Estonian: Dzuveo on opioidne valuvaigisti, mida kasutatakse mõõduka kuni tugeva valu raviks täiskasvanutel.
English: Dzuveo is available as 30 µg sublingual tablets.
Estonian: Dzuveot turustatakse 30 µg keelealuste tablettidena.
English: In the first study in 163 patients who had undergone abdominal surgery, pain reduced by 26 points with Dzuveo compared with 13 points with placebo (a dummy treatment).
Estonian: Esimeses uuringus (163 patsienti, kellele tehti kõhuõõneoperatsioon) vähenes valu tugevus Dzuveoga 26 punkti ja platseeboga (näiv ravim) 13 punkti.
English: What are the risks associated with Dzuveo?
Estonian: Mis riskid Dzuveoga kaasnevad?
English: The side effects seen with Dzuveo are those expected with opioids, and are considered manageable.
Estonian: Dzuveoga täheldatud kõrvalnähud on opioidide eeldatavad kõrvalnähud ning neid peetakse hallatavaks.
English: In the second study in 101 patients after foot surgery, pain reduced by around 6 points with Dzuveo and increased by around 7 points with placebo.
Estonian: Teises uuringus (101 patsienti, kellele tehti jalalaba operatsioon) vähenes valu tugevus Dzuveoga ligikaudu 6 punkti ja suurenes platseeboga ligikaudu 7 punkti.
English: They can be given the tablets as needed but should wait at least one hour after one tablet before having another.
Estonian: Patsientidele tohib anda tablette vastavalt vajadusele, kuid manustamiskordade vahele peab jääma vähemalt tund aega.
English: Attaching to these receptors in the brain helps relieve the patient's pain.
Estonian: Nende ajuretseptoritega seondudes aitab sufentaniil leevendada patsiendi valu.
English: For the full list of side effects and restrictions with Dzuveo, see the package leaflet.
Estonian: Dzuveo kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: How does Dzuveo work?
Estonian: Kuidas Dzuveo toimib?
English: Two main studies have shown that Dzuveo left to dissolve under the tongue is effective at reducing severe pain following surgeries.
Estonian: Kahes põhiuuringus tõendati, et keele alla lahustuma jäetud Dzuveo oli efektiivne tugeva operatsioonijärgse valu vähendamisel.
English: It is a ‘hybrid medicine'.
Estonian: Dzuveo on hübriidravim.
English: Studies show that Dzuveo is effective at reducing severe pain following surgeries.
Estonian: Uuringute kohaselt on Dzuveo efektiivne tugeva operatsioonijärgse valu vähendamisel.
English: The difference between the products is that Dzuveo is available as sublingual tablets (tablets to be dissolved under the tongue) while the reference medicine is a solution for injection.
Estonian: Ravimite erinevus on, et Dzuveot turustatakse keelealuste tablettidena ja võrdlusravim on süstelahus.
English: What benefits of Dzuveo have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Dzuveo kasulikkus?
English: How is Dzuveo used?
Estonian: Kuidas Dzuveot kasutatakse?
English: An overview of Dzuveo and why it is authorised in the EU
Estonian: Ülevaade ravimist Dzuveo ja ELis müügiloa väljastamise põhjendus
English: The active substance in Dzuveo, sufentanil, is an opioid that works by attaching to receptors (targets) in the brain known as μ-opioid receptors.
Estonian: Dzuveo toimeaine sufentaniil on opioid, mis seondub ajus olevate teatud retseptoritega, mida nimetatakse μ-opioidretseptoriteks.
English: Patients should not eat or drink and should talk as little as possible for the 10 minutes after taking the tablet.
Estonian: 10 minuti jooksul pärast tableti võtmist ei tohi patsient süüa ega juua ning peab hoiduma rääkimisest.
English: Dzuveo can only be obtained with a prescription.
Estonian: Dzuveo on retseptiravim.
English: Why is Dzuveo authorised in the EU?
Estonian: ELis Dzuveole väljastatud müügiloa põhjendus
English: The recommended dose is 60 mg once a day.
Estonian: Soovitatav annus on 60 mg üks kord ööpäevas.
English: Cabometyx received a marketing authorisation valid throughout the EU on 9 September 2016.
Estonian: Cabometyx on saanud müügiloa, mis kehtib kogu ELis, 9. septembril 2016.
English: Patients should not eat for at least two hours before and one hour after taking Cabometyx.
Estonian: Patsiendid ei tohi süüa vähemalt kaks tundi enne ja üks tund pärast Cabometyxi võtmist.
English: What measures are being taken to ensure the safe and effective use of Cabometyx?
Estonian: Mis meetmed võetakse, et tagada Cabometyxi ohutu ja efektiivne kasutamine?
English: Further information on Cabometyx can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/cabometyx.
Estonian: Lisateave Cabometyxi kohta on ameti veebilehel: ema.europa.eu/en/medicines/human/EPAR/cabometyx.
English: Cabometyx is available as tablets (20, 40 and 60 mg).
Estonian: Cabometyxit turustatakse tablettidena (20 mg, 40 mg ja 60 mg).
English: The European Medicines Agency therefore decided that Cabometyx's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas seepärast, et Cabometyxi kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: Treatment is continued for as long as the patient benefits from it or until side effects become unacceptable.
Estonian: Ravi jätkatakse, kuni see on patsiendile kasulik või kuni tekivad vastuvõetamatud kõrvalnähud.
English: These patients have poor outcomes and a high unmet medical need.
Estonian: Neil patsientidel on halb prognoos ja suur täitmata ravivajadus.
English: Cabometyx (cabozantinib)
Estonian: Cabometyx (kabosantiniib)
English: As for all medicines, data on the use of Cabometyx are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Cabometyxi kasutamise kohta pidevat järelevalvet.
English: By blocking the activity of these enzymes in cancer cells, the medicine reduces the growth and spread of the cancer.
Estonian: Nende ensüümide toime blokeerimisega vähirakkudes vähendab ravim vähkkasvaja kasvu ja levikut.
English: The improvement in survival observed is considered significant considering that these patients have poor outcomes and few treatment options available.
Estonian: Elumuse täheldatud pikenemist peetakse oluliseks, sest neil patsientidel on halb prognoos ja kättesaadavaid ravivõimalusi on vähe.
English: What is Cabometyx and what is it used for?
Estonian: Mis on Cabometyx ja milleks seda kasutatakse?
English: These enzymes can be found in certain receptors in cancer cells, where they are involved in activating processes that include cell division and the growth of new blood vessels to supply the cancer.
Estonian: Neid ensüüme leidub vähirakkude teatud retseptorites, kus need osalevad mitme protsessi aktiveerimisel, sh rakkude jagunemisel ja vähkkasvajat verega varustavate uute veresoonte kasvamisel.
English: Other information about Cabometyx
Estonian: Muu teave Cabometyxi kohta
English: For more information about using Cabometyx, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Cabometyxi kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cabometyx have been included in the summary of product characteristics and the package leaflet.
Estonian: Cabometyxi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.