FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-clinical data reveal no special hazard for humans based on available published data.
Estonian: Olemasolevate kirjanduses avaldatud mittekliiniliste andmete alusel ei ole täheldatud spetsiifilisi ohte inimestele.
English: Posology
Estonian: Viitenumber
English: The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to obtain the intended result.
Estonian: Manustatav radioaktiivsus peab olema selline, et see tagaks soovitud tulemused võimalikult väikese kiirgusdoosiga .
English: PHARMACEUTICAL FORM Radiopharmaceutical precursor, solution.
Estonian: Radiofarmatseutiline prekursor, lahus.
English: When an administration of radioactive medicinal products to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant.
Estonian: Kui fertiilses eas naisele on kavas manustada radioaktiivset ravimit, tuleb enne veenduda, et naine ei ole rase.
English: SPECIAL STORAGE CONDITIONS Store in the original package that provides protection from radiation, according to local regulation.
Estonian: SÄILITAMISE ERITINGIMUSED Hoida originaalpakendis, mis tagab kaitse kiirguse eest, säilitamise riiklikele seadustele.
English: What you need to know before the medicine radiolabelled with Cuprymina is used
Estonian: Mida on vaja teada enne Cupryminaga radiomärgistatud ravimi kasutamist
English: The dosimetry table below is presented in order to evaluate the contribution of non-conjugated Copper64 to the radiation dose following the administration of Copper-64-labelled medicinal product or resulting from an accidental intravenous injection of Cuprymina.
Estonian: Alltoodud dosimeetria tabeli alusel saab hinnata konjugeerimata vask-64 osa kiiritusdoosis pärast vask64-ga märgistatavate ravimpreparaatide manustamist või kui Cupryminat on tahtmatult veeni süstitud.
English: Cuprymina is stored under the responsibility of the specialist in appropriate premises.
Estonian: Cupryminat säilitab spetsialist selleks ettenähtud ruumides.
English: The radiation dose to the patient resulting from exposure after administration may result in higher incidence of cancer and mutations.
Estonian: Manustamisest tulenev kokkupuude kiirgusega võib suurendada vähkkasvajate ja mutatsioonide esinemissagedust.
English: Copper-64 decays in stable Nickel 64Ni (61 %) by an emission of β+ (18 %) or by an electronic capture (43 %).
Estonian: Vask-64 laguneb β+ kiirguse (18 %) eraldumisel või elektronhaarde (43 %) teel stabiilseks nikliks (64Ni) (61 %).
English: Cuprymina should be received, used and administered only by authorised persons in designated clinical settings.
Estonian: Cuprymina tohivad käsitseda ja manustada ainult volitatud isikud kliinilistes eritingimustes.
English: Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Estonian: Radiofarmatseutilisi preparaate tuleb säilitada vastavalt radioaktiivsete materjalide säilitamise riiklikele seadustele.
English: Healthcare personnel are advised to limit the time of close contact with patients injected with Copper-64-radiopharmaceuticals.
Estonian: Tervishoiutöötajatel soovitatakse võimalikult lühikest aega puutuda kokku patsientidega, kellele on süstitud vask-64-ga märgistatud radiofarmatseutilisi preparaate.
English: The quantity of Cuprymina required for radiolabelling and the quantity of Copper-64-labelled medicinal product that is subsequently administered will depend on the medicinal product radiolabelled and its intended use.
Estonian: Radiomärgistuseks vajaliku Cuprymina ja seejärel manustatava vask-64-ga märgistatud ravimpreparaadi kogus sõltub radiomärgistatud ravimpreparaadist ja selle kasutuseesmärgist.
English: The medicinal product must be aseptically withdrawn through the stopper using sterilised single-use needle and syringe after disinfecting the stopper.
Estonian: Selleks kasutatakse steriliseeritud ühekordset süstalt ja süstlanõela ning kork tuleb enne desinfitseerida.
English: 48 hours from date and time of End of Synthesis (EOS).
Estonian: 48 tundi alates sünteesi lõpu kuupäevast ja kellaajast.
English: Each pack contains 1 vial in a tungsten or lead container.
Estonian: Ühes pakendis on 1 viaalid pakendatud volframist või plii konteinerist.
English: The possible use of chelating therapies could interfere with the use of Copper-64-labelled medicinal products.
Estonian: Kelaativate ainete kasutamine võib mõjutada vask-64-ga radiomärgistatud ravimite kasutamist.
English: Relevant data is included in the Summary of Product Characteristics of the labelled medicinal products.
Estonian: Vastavad andmed on esitatud radiomärgistatavate ravimpreparaatide ravimi omaduste kokkuvõttes.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subjects to medical prescription.
Estonian: RAVIMI VÄLJASTAMISTINGIMUSED Retseptiravim.
English: Cuprymina is used for radiolabelling, a technique in which a substance is tagged (radiolabelled) with a radioactive compound.
Estonian: See on meetod, mille korral mingi aine märgistatakse (radiomärgistatakse) radioaktiivse ühendiga.
English: EXP {DD/MM/YYYY} hh:mm CET
Estonian: KÕLBLIKKUSAEG EXP {PP/KK/AAAA} (hh.mm Kesk-Euroopa aja järgi)SCAD
English: Località Cavallino 62010 Montecosaro (MC) - Italy
Estonian: Località Cavallino 62010 Montecosaro (MC) - Itaalia
English: Calibration time: {DD/MM/YYYY} 01h00 a.m. CET
Estonian: Radioaktiivsus: (Y) MBq Kalibreerimisaeg: {PP/KK/AAAA} kell 01.00 Kesk-Euroopa aja järgi
English: Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.
Estonian: Radiofarmatseutikume säilitatakse radioaktiivsete ainete säilitamise riiklike seaduste kohaselt.
English: (MBq: mega Becquerel, Becquerel is the unit in which radioactivity is measured) - The other ingredients are hydrochloric acid (0.1 N) and water for injections.
Estonian: (MBq: megabekrell; bekrell on radioaktiivsuse mõõtühik)
English: NAME OF THE MEDICINAL PRODUCT Cuprymina 925 MBq/mL radiopharmaceutical precursor, solution
Estonian: RAVIMPREPARAADI NIMETUS Cuprymina 925 MBq/ml radiofarmatseutiline prekursor, lahus
English: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Estonian: Radiofarmatseutilisi preparaate tohib käsitseda ja manustada ainult volitatud isikud spetsiaalsetes kliinilistes tingimustes.
English: Each mL of solution contains 925 MBq at calibration time (01h00 a.m. CET Central European Time), corresponding to at least 0.25 micrograms of copper-64.
Estonian: Üks ml lahust sisaldab kalibreerimisajal (kell 01.00 Kesk-Euroopa aja järgi) 925 MBq vask(64Cu)kloriidi, mis vastab vähemalt 0,25 mikrogrammile vask-64-le.
English: It contains the active substance copper (64Cu) chloride.
Estonian: − Toimeaine on vask(64Cu)kloriid.
English: The nuclear medicine doctor will inform you if you need to take any special precautions after receiving the medicine radiolabelled with Cuprymina.
Estonian: Pärast Cupryminaga radiomärgistatud ravimi manustamist Nukleaarmmeditsiini arst teavitab teid, kui peate pärast Cupryminaga radiomärgistatud ravimi manustamist järgima mingeid ettevaatusabinõusid.
English: The volume of one vial ranges from 1 to 3 mL solution (corresponding to 925 to 2,770 MBq at calibration time).
Estonian: Lahuse kogus viaalis on 1...3 milliliitrit (vastab 925...2770 MBq kalibreerimisajal).
English: The minimal specific activity is 3,700 MBq Copper-64/micrograms of Copper at the expiry date and time.
Estonian: Minimaalne spetsiifiline aktiivsus kõlblikkusaja lõpupäeval ja -ajal on 3700 MBq vask-64 mikrogrammis vases.
English: The radiation dose received by the various organs following intravenous administration of a Copper-64labelled medicinal product is dependent on the specific molecule being radiolabelled.
Estonian: vask-64-ga märgistatavate ravimite intravenoosse manustamise järgne kiiritusdoos eri organites sõltub spetsiifilisest radiomärgistatavast molekulist.
English: It will be the smallest quantity necessary to achieve the appropriate outcome, depending on the co-administered medicine and its intended use.
Estonian: Sõltuvalt Cupryminaga koos kasutatavast ravimist ja selle kasutamise eesmärgist kasutatakse väikseimat võimalikku annust, mis tagab soovitud tulemuse.
English: Please refer to the package leaflet of the medicine that is to be radiolabelled with Cuprymina.
Estonian: Palun tutvuge ka Cupryminaga radiomärgistatava ravimi pakendi infolehega.
English: Each vial contains an activity ranging from 925 MBq to 2,770 MBq (at calibration time) which corresponds to an amount of 0.25 to 0.75 micrograms of Copper-64.
Estonian: Ühes viaalis sisalduv aktiivsus on vahemikus 925...2770 MBq (kalibreerimisajal), mis vastab 0,25...0,75 mikrogrammile vask-64-le.
English: Copper-64 is a radioactive form of the chemical element copper, which emits the radiation needed for certain procedures that may be carried out on you.
Estonian: Vask-64 on keemilise elemendi vase radioaktiivne vorm.
English: IT-62010 MONTECOSARO (MC) Italy
Estonian: IT-62010 MONTECOSARO (MC) Itaalia
English: Before the use of Copper-64-labelled medicinal products, pregnancy should be excluded using an adequate/validated test.
Estonian: Enne vask-64-ga radiomärgistatud ravimpreparaatide kasutamist tuleb usaldusväärse meetodi abil rasedus välistada.
English: Activity: {Y}________MBq Cal.: {DD/MM/YYYY} 01h00 a.m. CET
Estonian: Radioaktiivsus: {Y}___________ MBq Kal.
English: 62010 Montecosaro (MC) Italy
Estonian: 62010 Montecosaro (MC) Itaalia
English: The vials are packed into a tungsten or lead container for protective shielding.
Estonian: Kiirguskaitse eesmärgil on viaalid pakendatud volframist või plii konteinerist.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING TUNGSTEN OR LEAD CONTAINER
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VOLFRAM VÕI PLII KONTEINER
English: Information on radiation dosimetry of each different medicinal product following administration of the radiolabelled preparation is available in the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Estonian: Radiomärgistatava preparaadi manustamise järgsed kiiritusdoosi andmed iga preparaadi kohta on esitatud radiomärgistatava ravimpreparaadi ravimi omaduste kokkuvõttes või pakendi infolehes.
English: Assuming the worst case that the whole maximum activity (2,770 MBq) is injected to the patient and Copper-64 is labelled to a molecule with infinite biological half-life (no disposal by the patient) the person is continuously exposed at a distance of 2 meters.
Estonian: Vask-64 gammakiirgusdoosi konstant on 1 meetri kaugusel 3,6 x 10-5 mSv x MBq-1 x h. Halvimas võimalikus olukorras, kui patsiendile manustatakse kogu maksimaalne radioaktiivsus (2770 MBq) ja Vask-64-ga radiomärgistatakse molekul, millel on lõpmatu bioloogiline poolestusaeg (st patsient ei erita seda), saab selline isik püsivat kiiritust 2 meetri kauguselt.
English: Adverse reactions following the intravenous administration of Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina, will be dependent on the specific medicinal product being used.
Estonian: Kõrvaltoimed, mis võivad tekkida pärast Cupryminaga radiomärgistatavate vask-64-ga märgistatavate ravimite intravenoosset manustamist, sõltuvad konkreetsest ravimist.
English: The administration of radioactive medicinal products creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc.
Estonian: Radioaktiivsete ravimpreparaatide väline kiirgus või kokkupuude näiteks patsiendi uriini või oksega on kõrvalistele isikutele ohtlik.
English: Such information is supplied in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Estonian: See teave on esitatud vastava radiomärgistatava preparaadi ravimi omaduste kokkuvõttes või pakendi infolehes.
English: Appendix V.
Estonian: Tabel 2.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Cuprymina 925 MBq/mL radiopharmaceutical precursor, solution.
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Cuprymina 925 MBq/ml radiofarmatseutiline prekursor, lahus Vask(64Cu)koriid
English: Grounds for one additional renewal
Estonian: Müügiloa veelkordse uuendamise alused
English: There could be effects on your ability to drive and to use machines due to the medicine used in combination with Cuprymina.
Estonian: Cupryminaga kombineeritud ravim võivad mõjutada autojuhtimise ja masinatega töötamise võimet.
English: Central European Time [CET]), corresponding to at least 0.25 micrograms of Copper-64.
Estonian: Euroopa aja järgi) 925 MBq vask(64Cu)kloriidi, mis vastab vähemalt 0,25 mikrogrammile vask
English: For information concerning special warnings and special precautions for use of Copper-64-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Estonian: Vask-64-ga märgistatavate ravimpreparaatidega seotud hoiatusi ja ettevaatusabinõusid vaadake vastavate radiomärgistatavate ravimite ravimi omaduste kokkuvõttest või pakendi infolehest.
English: Liver, gastrointestinal tract and kidney are the target organs for copper toxicity after single and repeated doses administration.
Estonian: Vase toksilisuse põhilisteks sihtorganiteks on nii ühekordsel kui ka korduval manustamisel maks, seedetrakt ja neerud.
English: Radiation protection precautions in accordance with national regulations must therefore be taken.
Estonian: Seetõttu tuleb tarvitusele võtta kohalikele nõuetele vastavad kiirguskaitsemeetmed.
English: For information on contraindications to particular Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina refer to the Summary of Product Characteristics/package leaflet of each particular medicinal product to be radiolabelled.
Estonian: Vask-64-ga märgistatavate ravimite vastunäidustusi radiomärgistamisel Cupryminaga lugege vastava radiomärgistatava preparaadi ravimi omaduste kokkuvõttest või pakendi infolehest.
English: 8735530 or 0039.0733.560354 Fax: 0039.0836.1975111 or 0039.0733.560376 E-mail: info@sparklepet.it
Estonian: Rinnanäärmed 0,000596 0,000730 0,000732 0,00133 0,00204 0,00384 0,00776 Sapipõie sein
English: Effects on ability to drive and to use machines following treatment by Copper-64-labelled medicinal products is specified in the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Estonian: Vask-64-ga märgistatud ravimite toime kohta autojuhtimisele ja masinate käsitsemise võimele lugege vastava radiomärgistatava preparaadi ravimi omaduste kokkuvõttest või pakendi infolehest.
English: Further information concerning the use of Copper-64-labelled medicinal products in pregnancy and breast-feeding is specified in the Summary of Product Characteristics of the medicinal product to be radiolabelled.
Estonian: Vask-64-ga märgistatud ravimite kasutamise kohta raseduse ja rinnaga toitmise ajal lugege vastava radiomärgistatava preparaadi ravimi omaduste kokkuvõttest või pakendi infolehest.
English: ULI wall heart wall kidneys liver lungs muscle ovaries pancreas red marrow 0.00581 0.00565 0.00670 0.0118 0.0242 0.0586 0.198 osteogenic cells skin spleen testes thymus thyroid urinary bladder wall 0.00 uterus effective dose ( Sv/1 GBq administered) adult male adult female 15 years 10 years 5 years 1 years newborn
Estonian: Osteogeneesi rakud 0,00202 0,00269 0,00263 0,00426 0,00718 0,0172 0,0549 Nahk
English: The surface dose
Estonian: Vastsü ndinu
English: For more information concerning paediatric use of Copper-64-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the radiolabelled medicinal product.
Estonian: Lisateavet vask-64-ga märgistatavate ravimpreparaatide kasutamise kohta lastel vaadake radiomärgistatud ravimpreparaadi ravimi omaduste kokkuvõttest või pakendi infolehest.
English: The pharmacodynamic properties of Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Estonian: Kasutades radiomärgistamisel Cupryminat, olenevad vask-64-ga märgistatavate ravimpreparaatide manustamiseelsed farmakodünaamilised omadused radiomärgistatava ravimpreparaadi omadustest.
English: The pharmacokinetic properties of Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Estonian: Cupryminaga radiomärgistatavate ravimpreparaatide manustamiseelsed farmakokineetilised omadused olenevad radiomärgistatava ravimpreparaadi omadustest.
English: Cuprymina is intended for in vitro radiolabelling of medicinal products, which are subsequently administered by the approved route.
Estonian: Cuprymina on ette nähtud ravimite märgistamiseks in vitro.
English: For information concerning interactions associated with the use of Copper-64-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the radiolabelled medicinal product.
Estonian: Vask-64-ga märgistatud ravimite koostoimete kohta lugege vastava radiomärgistatava preparaadi ravimi omaduste kokkuvõttest või pakendi infolehest.
English: The toxicological properties of Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina prior to administration will be dependent on the nature of the medicinal product to be radiolabelled.
Estonian: Cupryminaga radiomärgistatavate ravimite manustamiseelsed toksikoloogilised omadused sõltuvad radiomärgistatava ravimpreparaadi omadustest.
English: The presence of free copper (64Cu) chloride in the body after an inadvertent administration of
Estonian: Cuprymina tahtmatu manustamise järel organismi sattunud vaba vask(64Cu)kloriid võib suurendada hepatotoksilisust.
English: Table 1 - Condition of negligible radioactivity in the patients Days after injection (2,770 MBq)
Estonian: Päevi pärast süstimist (2770 MBq) Doosikiirus (nSv/h)
English: Your doctor will check whether Competact is working 3 to 6 months after you start taking it.
Estonian: Teie arst kontrollib, kas Competact toimib 3 kuni 6 kuud pärast selle kasutama hakkamist.
English: Competact should be used every day to work properly.
Estonian: Competacti tuleb võtta iga päev, et see korralikult toimiks.
English: County Wicklow Ireland
Estonian: Count Wicklow Iirimaa
English: Other medicines and Competact
Estonian: Muud ravimid ja Competact
English: The recommended dose is one tablet taken twice daily.
Estonian: Soovitatav annus on üks tablett kaks korda päevas.
English: Individual cartons not to be sold separately.
Estonian: Üksikuid pakendeid eraldi ei müüda.
English: Packs of 14, 28, 30, 50, 56, 60, 90, 98, 112, 180.
Estonian: Pakendid 14, 28, 30, 50, 56, 60, 90, 98, 112, 180 tabletiga.
English: Competact with alcohol
Estonian: Competact koos alkoholiga
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud karbil ja blistril pärast “EXP“.
English: The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Estonian: Uuringus osalenute keskmine vanus oli 62 aastat ja diabeedi keskmine kestus oli 9,5 aastat.
English: GFR mL/min Metformin
Estonian: GFR ml/min
English: Competact has no or negligible influence on the ability to drive and use machines.
Estonian: Competact ei mõjuta või mõjutab ebaoluliselt autojuhtimise ja masinate käsitsemise võimet.
English: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland Delpharm Novara S.r.l., Via Crosa, 86, I-28065 Cerano (NO), Italy Lilly S.A., Avda.
Estonian: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Iirimaa Delpharm Novara S.r.l., Via Crosa, 86, I-28065 Cerano (NO), Itaalia Lilly S.A., Avda.
English: This check should be repeated at intervals.
Estonian: Seda uuringut tuleks teatud ajavahemike järel korrata.
English: The safety and efficacy of Competact in children and adolescents under 18 years of age have not been established.
Estonian: Competacti ohutus ja efektiivsus lastel ja alla 18-aastastel noorukitel ei ole tõestatud.
English: Patients should be aware of the risk of pregnancy and if a patient wishes to become pregnant or if pregnancy occurs, the treatment should be discontinued (see section 4.6).
Estonian: Patsiendid peavad olema teadlikud rasestumise riskist ning kui patsient soovib rasestuda või kui rasestumine on toimunud, tuleb ravi lõpetada (vt lõik 4.6).
English: Competact should be discontinued if any deterioration in cardiac status occurs.
Estonian: Competacti kasutamine tuleb katkestada, kui esineb kardiaalse staatuse halvenemine.
English: de la Industria 30, 28108 Alcobendas, Madrid, Spain
Estonian: de la Industria 30, 28108 Alcobendas, Madrid, Hispaania
English: Aluminium/aluminium blisters.
Estonian: Alumiinium/alumiiniumblistrid.
English: FOR CALENDARISED PACKS: 7 Tablet blister
Estonian: KALENDRIGA VARUSTATUD PAKENDITEL: 7 tabletiga blister
English: If you take Competact with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).
Estonian: Kui te võtate Competacti koos teiste diabeediravimitega, on tõenäolisem, et teie veresuhkru tase võib langeda alla normaalse taseme (hüpoglükeemia).
English: Your doctor will decide when you must stop and when to restart your treatment with Competact.
Estonian: Teie arst otsustab, millal te peate lõpetama ja millal tohite uuesti alustada ravi Competactiga.
English: Take Competact daily as prescribed.
Estonian: Tarvitage Competacti ettekirjutuse järgi iga päev.
English: The mean Vd ranged between 63-276 L.
Estonian: Keskmine jaotusruumala on 63-276 l.
English: Use in children and adolescents under 18 years is not recommended.
Estonian: Lapsed ja noorukid Ei ole soovitatav kasutada alla 18 aasta vanustel lastel ja noorukitel.
English: Hypromellose Macrogol 8000
Estonian: Hüpromelloos Makrogool 8000 Talk
English: 14 Tablet blister
Estonian: 14 tabletiga blister
English: If you need to have major surgery you must stop taking Competact during and for some time after the procedure.
Estonian: Kui teil seisab ees suurem operatsioon, peate te lõpetama Competacti võtmise operatsiooni ajaks ja mõneks ajaks pärast protseduuri.
English: If you stop using Competact, your blood sugar may go up.
Estonian: Kui te lõpetate Competacti võtmise, võib teie veresuhkur minna kõrgeks.
English: During treatment with Competact, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Estonian: Ravi ajal Competactiga kontrollib arst teie neerufunktsiooni vähemalt üks kord aastas või sagedamini, kui te olete eakas ja/või teie neerufunktsioon halveneb.
English: If no adequate strength of Competact is available, individual monocomponents should be used instead of the fixed dose combination.
Estonian: Kui puudub Competacti sobiv tugevus, tuleb fikseeritud annuse kombinatsioonravimi asemel kasutada eraldi toimeaineid.
English: - do not use Competact if you are breastfeeding or are planning to breast-feed (see section “Do not take Competact”).
Estonian: - Ärge kasutage Competacti, kui te imetate last või kavatsete imetama hakata (vt lõik „Ärge võtke Competacti“).
English: If you have a serious allergic reaction, including hives and swelling of the face, lips, tongue, or throat that may cause difficulty in breathing or swallowing, stop taking this medicine and talk to your doctor immediately.
Estonian: Kui teil tekib tõsine allergiline reaktsioon, sealhulgas nõgestõbi ja näo, huulte, keele või kõri turse, mis võib põhjustada hingamis- või neelamisraskusi, lõpetage selle ravimi võtmine ja rääkige sellest kohe oma arstile.
English: What Competact is and what it is used for
Estonian: Mis ravim on Competact ja milleks seda kasutatakse
English: Date of first authorisation: 28/07/2006 Date of latest renewal: 25/04/2016
Estonian: Müügiloa viimase uuendamise kuupäev: 25/04/2016