FrancophonIA/ELRC3.0 huggingface dataset:
English: Additionally, due to the death and breakage of the malignant cells by the therapy, there is a possibility that you experience an excessive release of hormones from these cells increasing or triggering neuroendocrine tumour related symptoms such as diarrhoea, flushing and hot flushes, heartbeat disorder, shortness of breath, etc. Should you experience such symptoms: inform your doctor immediately, who may request that you stay at the hospital for observation and treatment if necessary.
Estonian: Lisaks võib ravi tulemusena tekkinud pahaloomuliste rakkude surm ja lagunemine põhjustada olukorda, kus teil tekib antud rakkudest hormoonide liiga suur vabanemine, suurendades või käivitades neuroendokriinse kasvajaga seotud sümptomeid nagu kõhulahtisus, õhetus ja kuumahood, südametegevuse häire, õhupuudustunne jne.
English: METHOD OF ADMINISTRATION Single-dose vial.
Estonian: MANUSTAMISVIIS Üheannuseline viaal.
English: Pregnancy No studies on animal reproductive function have been conducted with lutetium (177Lu) oxodotreotide.
Estonian: Rasedus Loomade reproduktiivsuuringuid luteetsium (177Lu) oksodotreotiidiga ei ole tehtud .
English: - If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
Estonian: - Kui teil on lisaküsimusi, pidage nõu oma nukleaarmeditsiini arstiga, kes protseduuri eest vastutab.
English: Dizziness Dysgeusia Headache10
Estonian: Pearinglus Düsgeusia Peavalu10
English: Injection site reaction11
Estonian: Süstekoha reaktsioon11
English: Any haematological toxicity of grade 3 or superior (CTCAE)**, except lymphopenia.
Estonian: Mistahes 3. või kõrgema astme (CTCAE)** hematoloogiline toksilisus, v.a. lümfopeenia.
English: • Renal or urinary tract morphological abnormalities;
Estonian: • Neerude või kuseteede morfoloogilised kõrvalekalded;
English: Dosing may need to be modified based on the tests results.
Estonian: Analüüside tulemuste põhjal võib tekkida vajadus annust muuta.
English: What Lutathera contains - The active substance is lutetium (177Lu) oxodotreotide.
Estonian: Mida Lutathera sisaldab - Toimeaine on luteetsium (177Lu) oksodotreotiid.
English: The medicinal product should be infused through an intravenous catheter placed in the vein exclusively for its infusion.
Estonian: Ravimit tuleb infundeerida intravenoosse kateetri abil, mis asetatakse veeni ainult selle infusiooni ajaks.
English: • Bone metastasis;
Estonian: • Luumetastaasid;
English: For renal protection purpose, an amino acid solution must be administered intravenously during 4 hours.
Estonian: Neerude kaitsmiseks tuleb intravenoosselt manustada aminohapete lahust 4 tunni jooksul.
English: It is helpful to estimate the effective dose that was applied.
Estonian: Abi võib olla manustatud efektiivdoosi hindamisest.
English: The following conclusions on treatment with Lutathera were determined from radiation dosimetry evaluations performed in clinical studies:
Estonian: Kliinilistes uuringutes tehtud dosimeetrilistel mõõtmisel tehti Lutathera ravi kohta järgmised järeldused:
English: • The infusion set should be connected to the bag of sodium chloride 9 mg/mL (0.9%) solution for injection and pre-filled by opening the clamp.
Estonian: • Infusioonisüsteem peab olema ühendatud naatriumkloriidi 9 mg/ml (0,9%) süstelahuse kotiga ja eeltäidetud klambri avamise teel.
English: Toxicological studies with rats have demonstrated that a single intravenous injection of up to 4,550 MBq/kg was well tolerated and no deaths were observed.
Estonian: 4550 MBq/kg oli hästi talutav ja surmajuhtumeid ei täheldatud.
English: Administration procedure of antiemetic amino acid solution and Lutathera
Estonian: Antiemeetikumi, aminohapete lahuse ja Lutathera manustamisprotseduur
English: Nephrotoxicity Lutetium (177Lu) oxodotreotide is excreted by the kidney.
Estonian: Nefrotoksilisus Luteetsium (177Lu) oksodotreotiid elimineeritakse neerude kaudu.
English: Nausea, vomiting, fatigue, low platelet count (thrombocytopenia), low white blood cell count (lymphopenia), low red cell count (anaemia), decreased appetite, decreased all blood cell count (pancytopenia)
Estonian: Iiveldus, oksendamine, väsimus, madal trombotsüütide arv (trombotsütopeenia), madal valgete vereliblede arv (lümfopeenia), madal punaliblede arv (aneemia), isu vähenemine, vererakkude arvu vähenemine (pantsütopeenia).
English: The vial is enclosed within a lead container for protective shielding.
Estonian: Viaal on paigaldatud pliikonteinerisse kaitsevarjestuse tagamiseks.
English: • The tubing line should be pre-filled with sodium chloride 9 mg/mL (0.9%) solution for injection and then connected with a venous catheter previously inserted to the patient's arm.
Estonian: • Infusioonitorusid tuleb eelnevalt täita naatriumkloriidi 9 mg/ml (0,9%) süstelahusega ja seejärel ühendada patsiendi käele eelnevalt paigaldatud veenikateetriga.
English: Patients with urinary incontinence
Estonian: Uriinipidamatusega patsiendid
English: The European Medicines Agency has waived the obligation to submit the results of studies with Lutathera in all subsets of the paediatric population in the treatment of GEP-NETs (excluding neuroblastoma, neuroganglioblastoma, phaeochromocytoma).
Estonian: Euroopa Ravimiamet ei kohusta esitama Lutatheraga läbi viidud uuringute tulemusi laste kõikide alarühmade kohta GEP-NET ravi puhul (v.a neuroblastoom, neuroganglioblastoom, feokromotsütoom) (teave lastel kasutamise kohta: vt lõik 4.2).
English: • Haematology (Haemoglobin [Hb], white blood count, platelet count)
Estonian: • Hematoloogia (hemoglobiin [Hb], leukotsüütide arv, trombotsüütide arv)
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting etc.
Estonian: Radiofarmatseutiliste preparaatide manustamine ohustab teisi isikuid lisaks preparaadile, uriini-, okse-, verepritsmetest jm eralduv kiirgus.
English: Volumetric activity at calibration time: 370 MBq/mL - {DD/MM/YYYY hh:mm UTC} Activity at infusion time: {Z} MBq - {DD/MM/YYYY hh:mm UTC}
Estonian: Mahuaktiivsus kalibreerimise ajal: 370 MBq/ml - {PP/KK/AAAA hh:mm UTC} Aktiivsus infusiooni ajal: : {Z} MBq - {PP/KK/AAAA hh:mm UTC}
English: If the half dose is well tolerated (i.e. no DMT reoccurrence), the next remaining treatment administration(s) should continue with full dose (i.e. 7,400 MBq); but, if DMT recurs after treatment with a half dose, treatment with Lutathera must be definitively stopped.
Estonian: 7400 MBq); kuid kui DMT kordub pärast ravi poole annusega, tuleb ravi Lutatheraga kindlasti katkestada.
English: To avoid treatment-related nausea and vomiting, an intravenous bolus of an antiemetic medicinal product should be injected 30 minutes before the start of amino acid solution infusion (see section
Estonian: Raviga seotud iivelduse ja oksendamise vältimiseks süstitakse intravenoosne antiemeetikumi boolus 30 minutit enne aminohapete lahuse infusiooni alustamist (vt lõik 4.2).
English: Lutathera must not be used after the expiry date which is stated on the label after EXP. Store below 25 ºC.
Estonian: Lutatherat ei tohi kasutada pärast kõlblikkusaja möödumist, mis on märgitud karbil pärast märget „kõlblik kuni:“.
English: • Administration room:
Estonian: • Manustamisruum:
English: Urinary incontinence Glomerular filtration rate decreased Renal disorder
Estonian: Leukotsütopeenia Uriinipidamatus Glomerulaarfiltratsiooni kiirus vähenenud
English: Lysine content
Estonian: Lüsiini sisaldus
English: It is not recommended to decrease the amount of amino acid solution in case of Lutathera dose adaptation.
Estonian: Lutathera annuse kohandamise korral ei ole soovitatav aminohapete lahuse kogust vähendada.
English: Excipient with known effect Each mL of solution contains 0.14 mmol (3.2 mg) of sodium.
Estonian: Teadaolevat toimet omav abiaine Üks lahuse ml sisaldab 0,14 mmol (32 mg) naatriumi.
English: After administration of Lutathera
Estonian: Pärast Lutathera manustamist
English: See leaflet for further information.
Estonian: Vt lisateavet infolehest.
English: Refractory cytopenia with unilineage dysplasia Nephrogenic anaemia Bone marrow failure Thrombocytopenic purpura
Estonian: Refraktaarne tsütopeenia unilineaarse düsplaasiaga Nefrogeenne aneemia Luuüdipuudulikkus Trombotsütopeeniline purpur
English: PFS Kaplan Meier curves of patients with progressive midgut carcinoid tumourcut-off date 30 June 2016 (NETTER-1 phase III study; FAS, N=231)
Estonian: PFS Kaplan Meieri kõverad kesksoole progresseeruva pahaloomulise kasvajaga patsientidel - lõpu kuupäev 30. juuni 2016 (NETTER-1 III faasi uuring; FAS, N=231)
English: Bone marrow toxicity
Estonian: Luuüdi toksilisus
English: There is no relevant use of Lutathera in the paediatric population in the indication of treatment of GEP-NETs (excluding neuroblastoma, neuroganglioblastoma, phaeochromocytoma).
Estonian: Lastel ei ole GEP-NET-de (v.a neuroblastoom, neuroganglioblastoom, feokromotsütoom) ravi Lutatheraga asjakohane.
English: PFS Kaplan Meier curves of patients with progressive midgut carcinoid tumour - cutoff date 24 July 2015 (NETTER-1 phase III study; FAS, N=229)
Estonian: PFS Kaplan Meieri kõverad kesksoole progresseeruva pahaloomulise kasvajaga patsientidel - lõpu kuupäev 24. juuli 2015 (NETTER-1 III faasi uuring; FAS, N=229)
English: If you have been given more Lutathera than you should An overdose is unlikely because you will only receive a single dose of Lutathera precisely controlled by the nuclear medicine doctor supervising the administration procedure.
Estonian: Üleannustamine on ebatõenäoline, sest protseduur toimub kontrollitud tingimustes ja selle eest vastutav nukleaarmeditsiini arst manustab teile üksiku annuse.
English: The infusion of the amino acid solution should start 30 minutes prior to start of Lutathera infusion.
Estonian: Aminohapete lahuse infusiooniga tuleb alustada 30 minutit enne Lutathera infusiooni.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING LEAD SHIELDING CONTAINER
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED PLII VARJUSTUSEGA KONTEINER
English: Hyperparathyroidism
Estonian: Hüpomagneseemia
English: Paediatric population
Estonian: Ajumetastaasidega patsiendid
English: For information on the use in patients with renal impairment, see section 4.2.
Estonian: Teavet kasutamise kohta neerukahjustusega patsientidel vt lõik 4.2.
English: Criteria for temporary discontinuation treatment with Lutathera
Estonian: Lutathera ravi ajutise katkestamise kriteeriumid
English: Specification of commercially available amino acid solutions Characteristic
Estonian: Müügiks kättesaadavate aminohapete lahuste nõuded Tunnused
English: PFS observed in the NETTER-1 phase III study in patients with progressive midgut carcinoid tumour - cut-off date 30 June 2016 (full analyses set (FAS), N=231)
Estonian: PFS, mida täheldati NETTER-1 III faasi uuringus kesksoole progresseeruva pahaloomulise kasvajaga patsientidel - lõpu kuupäev 30. juuni 2016 (täielik analüüside komplekt (FAS), N=231)
English: Criteria for permanent discontinuation of treatment with Lutathera
Estonian: Kriteeriumid Lutathera ravi lõpetamiseks
English: Tabulated list of adverse reactions The adverse reactions are listed in Table 7 according to the frequency and the MedDRA System Organ
Estonian: Kõrvaltoimed on loetletud vastavalt sagedusele ja MedDRA organsüsteemi klassidele (SOC).
English: Scheme of instructions for dose modifications
Estonian: Annuse muutmise juhised
English: PFS observed in the NETTER-1 phase III study in patients with progressive midgut carcinoid tumour - cut-off date 24 July 2015 (full analyses set (FAS), N=229)
Estonian: PFS, mida täheldati NETTER-1 III faasi uuringus kesksoole progresseeruva pahaloomulise kasvajaga patsientidel - lõpu kuupäev 24. juuli 2015 (täielik analüüside komplekt (FAS), N=229)
English: Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Estonian: Kuni pole teisiti tõestatud, tuleb igat naissoost patsienti, kellel on menstruatsioon vahele jäänud, käsitleda kui rasedat.
English: For additional details about the treatment of patient with mild to moderate hepatic impairment, see Table 5 and section 4.4.
Estonian: Täiendavat teavet kerge kuni mõõduka maksakahjustusega patsientide ravi kohta vt tabel 5 ja lõik 4.4.
English: • Patients with somatostatin receptor negative or mixed visceral lesions (tumour uptake score < 2)
Estonian: • Patsiendid, kelle kasvaja vistseraalsed kolded on somatostatiini retseptoritele negatiivsed või osaliselt negatiivsed (kasvaja omastamisvõime skoor < 2) vastavalt somatostatiini retseptorite visualiseerivale uuringule.
English: NAME OF THE MEDICINAL PRODUCT Lutathera 370 MBq/mL solution for infusion
Estonian: RAVIMPREPARAADI NIMETUS Lutathera 370 MBq/ml infusioonilahus
English: When the recommended concomitant amino acids infusion is delivered over a 4 hour time span, a mean reduction in kidney radiation exposure of about 47% has been reported.
Estonian: On leitud, et neerude keskmine kiirguskoormus vähenes 47%, kui samaaegselt 4 tunni jooksul toimus soovitatud aminohapete infusioon .
English: 2.2 mm (mean penetration range of 0.67 mm), which is sufficient to kill targeted tumour cells with a limited effect on neighbouring normal cells.
Estonian: Luteetsium-177 (177Lu) on β-kiirgust kiirgav radionukliid, mille maksimaalne kudedesse tungimise sügavus on 2,2 mm (keskmine tungimise sügavus on 0,67 mm), mis on piisav kasvaja sihtrakkude tapmiseks ning piiratud mõjuga normaalsetele naaberrakkudele.
English: Lutathera 370 MBq/mL solution for infusion Lutetium (177Lu) oxodotreotide
Estonian: Lutathera 370 MBq/ml infusioonilahus Luteetsium (177Lu) oksodotreotiid
English: Malta: ADR Reporting - Website: www.medicinesauthority.gov.mt/adrportal
Estonian: Eesti: Ravimiamet, Koduleht: www.ravimiamet.ee.
English: When testing the cold compound (non-radioactive lutetium (175Lu) oxodotreotide) as a single intravenous injection in rats and dogs at doses up to 20,000 µg/kg (rats) and 3,200 µg/kg (dogs), the compound was well tolerated in both species and no deaths were observed.
Estonian: 000 μg/kg (rotid) ja 3200 μg/kg (koerad), oli ühend mõlemas liigiisendis hästi talutav ning surmasid ei täheldatud.
English: Storage of the vial
Estonian: Viaali säilitamine
English: Duration
Estonian: Kestvus
English: Thrombocytopenia2 Lymphopenia3
Estonian: Trombotsütopeenia2 Lümfopeenia3
English: No animal studies have been performed to determine the effects of lutetium (177Lu) oxodotreotide on the fertility of either gender.
Estonian: Loomkatseid luteetsium (177Lu) oksodotreotiidi mõjust kummagi soo viljakusele ei ole tehtud.
English: Antiemetic premedication should be administered 30 minutes before start of amino acid solution infusion.
Estonian: Antiemeetiline ennetav ravim tuleb manustada 30 minutit enne aminohapete lahuse infusiooni alustamist.
English: Cryopreservation of sperm or eggs may be offered to you before the treatment.
Estonian: Enne ravi võib patsientidele pakkuda sperma või munarakkude külmsäilitamise.
English: − The floor and the furniture should be covered with tissue paper to avoid any accidental contamination
Estonian: − Et vältida juhuslikku saastumist, peavad põrand ja mööbel olema pehmepaberiga kaetud
English: Arginine content
Estonian: Arginiini sisaldus
English: Acute prerenal failure Renal impairment
Estonian: Äge prerenaalne puudulikkus Neerukahjustus
English: Disposable waterproof gloves should be worn.
Estonian: Tuleb kanda ühekordselt kasutatavaid veekindlaid kindaid.
English: Lutathera contains sodium
Estonian: Lutathera sisaldab naatriumi
English: To be taken into consideration by patients on controlled sodium diet.
Estonian: Sellega arvestada patsientidel, kes jälgivad soola taset toidus.
English: Blood potassium decreased Blood urea increased Glycosylated haemoglobin increased
Estonian: Vere kaaliumisisalduse langus Uurea sisalduse tõus veres Glükeeritud hemoglobiini tõus Hematokriti vähenemine Valk uriinis
English: Contact your nuclear medicine doctor if you have any questions.
Estonian: Kui teil on mis tahes küsimusi, võtke ühendust oma nukleaarmeditsiini arstiga.
English: • Urinary incontinence;
Estonian: • Kusepidamatus;
English: One mL of solution contains 370 MBq of lutetium (177Lu) oxodotreotide at the date and time of calibration.
Estonian: Üks ml lahust sisaldab 370 MBq luteetsium (177Lu) oksodotreotiidi kalibreerimise kuupäeval ja kellaajal.
English: Swelling face Hyperhidrosis Pruritus generalized
Estonian: Kuiv nahk Turses nägu Hüperhidroos Üldine pruritus
English: Acute myeloid leukaemia Acute leukaemia Chronic myelomonocytic leukaemia
Estonian: Krooniline müelomonotsütaarne leukeemia
English: Premedication with antiemetics should be injected 30 minutes before the start of amino acid solution infusion.
Estonian: Premedikatsiooniks tuleb antiemeetikume süstida 30 minutit enne aminohapete lahuse infusiooni alustamist.
English: oxodotreotide through the proximal tubules, resulting in a significant reduction in the kidney radiation dose (see section 4.2).
Estonian: Aminohapete lahus aitab vähendada luteetsium (177Lu) oksodotreotiidi resorptsiooni proksimaalsetes tuubulites, mis tunduvalt vähendab neerude kiirguskoormust (vt lõik 4.2).
English: Action
Estonian: Toiming
English: Gastrointestinal pain Stomatitis
Estonian: Seedetrakti valu Stomatiit
English: • The package leaflet
Estonian: • Pakendi infolehte
English: Organ uptake At 4 hours after administration, the distribution pattern of lutetium (177Lu) oxodotreotide shows a rapid uptake in kidneys, tumour lesions, liver and spleen, and in some patients in the pituitary gland and in the thyroid.
Estonian: Omastamine organis 4. tunnil pärast manustamist neeldub luteetsium (177Lu) oksodotreotiid neerudesse, kasvaja kolletesse,
English: AT, BE, BG, CZ, FR, HR, HU, IS, LU, LV, LT, MT, NL, RO, SI, SK Advanced Accelerator Applications Tel/Tél/Teл/Sími: + 33 4 50 99 30 70
Estonian: LV, LT, MT, NL, RO, SI, SK
English: Gallbladder Wall Lower Large Intestine Wall Small Intestine Stomach Wall
Estonian: Kõhu distensioon Kõhulahtisus Kõhuvalu Kõhukinnisus Ülakõhu valu Düspepsia Gastriit
English: Acute kidney injury Haematuria Renal failure Proteinuria
Estonian: Äge neeruvigastus Hematuuria Neerupuudulikkus Proteinuuria
English: NAME OF THE MEDICINAL PRODUCT Lutathera 370 MBq/mL solution for infusion Lutetium (177Lu) oxodotreotide
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D ) Lutathera 370 MBq/ml infusioonilahus Luteetsium (177Lu) oksodotreotiid
English: How Lutathera is stored
Estonian: Kuidas säilitada Lutatherat
English: Secondary malignant neoplasms
Estonian: Sekundaarsed pahaloomulised kasvajad
English: Pancreatitis acute Rectal haemorrhage Melaena
Estonian: Äge pankreatiit Rektaalne hemorraagia Meleena
English: Hepatobiliary disorders
Estonian: Hüponatreemia
English: Abdominal cavity drainage Dialysis
Estonian: Kõhuõõne drenaaž Dialüüs
English: Kidneys
Estonian: Neeruhäired
English: STATEMENT OF ACTIVE SUBSTANCE(S) One mL contains 370 MBq of lutetium (177Lu) oxodotreotide at calibration time.
Estonian: Üks ml sisaldab kalibreerimisajal 370 MBq luteetsium (177Lu) oksodotreotiidi.
English: What Lutathera is and what it is used for 2.
Estonian: 1. Mis ravim on Lutathera ja milleks seda kasutatakse 2. Mida on vaja teada enne Lutathera kasutamist 3.
English: Breast-feeding It is unknown whether lutetium (177Lu) oxodotreotide is excreted in breast milk.
Estonian: Biojaotuvuse uuringud näitavad, et luteetsium (177Lu) oksodotreotiid eritub verest kiiresti.
English: − One vial of Lutathera
Estonian: − Üks Lutathera viaal
English: Hypersensitivity
Estonian: Kuumahood Hüpotensioon
English: The pharmacokinetic profile of lutetium (177Lu) oxodotreotide in patients with severe hepatic impairment has not been studied,
Estonian: Luteetsium (177Lu) oksodotreotiidi farmakokineetilist profiili tõsise maksakahjustusega patsientidel ei ole veel uuritud, seega antud patsiente ei soovitata Lutatheraga ravida.
English: Oropharyngeal pain Pleural effusion Sputum increased Choecking sensation
Estonian: Orofarüngeaalne valu Pleuraefusioon Rögaeritus suurenenud Lämbumise tunne
English: Secondary hypothyroidism Hypothyroidism Diabetes mellitus
Estonian: Hüpotüreoidism Suhkurtõbi Kartsinoidsündroom Hüperparatüreoidism
English: Ear and labyrinth
Estonian: Kõrva ja labürindi kahjustused
English: Temporarily discontinue the treatment.
Estonian: Katkestage ajutiselt Lutathera manustamine.
English: Hindgut
Estonian: Neerud
English: Blood lactate dehydrogenase
Estonian: Söögiisu vähenemine Hüperglükeemia Dehüdratsioon
English: Weight decreased Blood creatine phosphokinase increased
Estonian: Kehakaalu langus Kreatiini fosfokinaasi tõus veres Vere laktaadi dehüdrogenaasi tõus Vere katehhoolamiinid C-reaktiivse valgu tõus
English: Specification
Estonian: Erihoiatused
English: Atrial fibrillation Palpitations Myocardial infarction Angina pectoris Cardiogenic shock
Estonian: Kodade virvendus Palpitatsioonid Müokardiinfarkt Stenokardia Kardiogeenne šokk
English: Hepatic encephalopathy Paraesthesia Parosmia
Estonian: Formikatsioon Hepaatiline entsefalopaatia Paresteesia
English: Clavicle fracture
Estonian: Küünarluu murd
English: Posology
Estonian: Parosmia
English: This may be of concern to the immediate family of those individuals undergoing treatment or the general public depending on the level of activity administered, hence radioprotection rules should be followed (section 4.4).
Estonian: Sõltuvalt manustatava aktiivsusest võib see olla probleemiks ravi saavate inimeste lähedastele pereliikmetele või üldisele populatsioonile, .
English: Hepatic impairment
Estonian: Hemorraagiline astsiit Iileus
English: Upper Large Intestine Wall Heart Wall
Estonian: Jämesoole ülaosa sein Südame sein
English: Decreased appetite
Estonian: Seljaaju kompressioon
English: Thymus
Estonian: Surmad
English: Gastrointestinal tube insertion Stent placement Abscess drainage Bone marrow harvest Polypectomy
Estonian: Seedetrakti sondi sisestamine Stendi paigaldamine Abstsessi dreneerimine
English: Haematochezia Abdominal discomfort Intestinal obstruction Colitis
Estonian: Ebamugavustunne kõhus Soole obstruktsioon Koliit
English: Leukocyturia
Estonian: Peapööritus
English: EXPIRY DATE EXP: {DD MM YYYY hh:mm UTC}
Estonian: KÕLBLIKKUSAEG Kõlblik kuni: {PP.KK.AAAA hh:mm UTC}
English: Formication
Estonian: Imetamine
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Estonian: TOIMEAINE(TE ) SISALDUS
English: Pain
Estonian: Emakas
English: Flatulence
Estonian: Neerupealised
English: Dry skin
Estonian: Kusepõie sein
English: Common
Estonian: Tüümus
English: Red Marrow
Estonian: Punene luuüdi
English: Do not give this medicine to children (under 12 years of age) because it does not work.
Estonian: Ärge andke seda ravimit lastele (alla 12-aastastele), kuna see ei toimi.
English: Krka, d.d., Novo mesto Šmarješka cesta 6
Estonian: Krka, d.d., Novo mesto- Locna Šmarješka cesta 6
English: • Your doctor may order blood tests.
Estonian: • teie arst võib teile määrata vereanalüüse.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Estonian: Müügiloa hoidja peab tagama, et ravimiohutuse järelevalve süsteem, nagu on kirjeldatud müügiloa moodulis 1.8.1, on loodud ja toimib enne toote turuletulekut ja toote turustamise ajal.
English: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder
Estonian: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Sloveenia Lisaküsimuste tekkimisel selle ravimi kohta pöörduge palun müügiloa hoidja kohaliku esindaja poole.
English: It is preferable not to take this product during pregnancy.
Estonian: Seda ravimit on parem mitte võtta raseduse ajal.
English: Ísland ratiopharm Oy
Estonian: Ísland ratiopharm Oy Finnland
English: • You should tell your doctor if a surgery (including dental) is planned.
Estonian: • te peate rääkime oma arstile, kui teile on planeeritud kirurgiline operatsioon (sh hambaoperatsioon);