FrancophonIA/ELRC3.0 huggingface dataset:
English: Each 2 ml vial contains 200 μg ziconotide (as acetate).
Estonian: Iga 2 ml viaal sisaldab 200 μg zikonotiidi (atsetaadina).
English: - One ml solution contains 25 micrograms ziconotide (as acetate).
Estonian: - Üks ml lahust sisaldab 25 mikrogrammi zikonotiidi (atsetaadina).
English: - Each 20 ml vial contains 500 micrograms ziconotide (as acetate).
Estonian: - Iga 20 ml viaal sisaldab 500 mikrogrammi zikonotiidi (atsetaadina).
English: Elevations in creatine kinase, which are usually asymptomatic, are common amongst patients on intrathecal ziconotide.
Estonian: Intratekaalset zikonotiid-ravi saavatel patsientidel suureneb sageli kreatiinkinaasi aktiivsus, mis on üldjuhul asümptomaatiline.
English: In one clinical study a male cancer patient received an accidental IT ziconotide overdose of 744 μg over a 24-hour period (31 μg/hour) and resumed treatment at the intended dose after experiencing a reduction in Visual Analog Scale of Pain Intensity (VASPI) from 82 to 2.5 mm.
Estonian: Seejärel jätkati uuesti ravi ettenähtud annustega pärast seda, kui valuskoor oli visuaal-analoogse skaala (VASPI, Visual Analog Scale of Pain Intensity) järgi langenud 82 mm-lt 2,5 mm-le.
English: Intrathecal use
Estonian: Manustamisviis
English: Caution should be exercised when ziconotide is administered to patients who are receiving systemic chemotherapy (see section 4.5).
Estonian: Süsteemset keemiaravi saavatele patsientidele tuleb zikonotiidi manustada ettevaatusega (vt lõik 4.5).
English: Each 5 ml vial contains 500 μg ziconotide (as acetate).
Estonian: Iga 5 ml viaal sisaldab 500 μg zikonotiidi (atsetaadina).
English: - If you notice any adverse change in your thinking, mood or memory, please tell your doctor.
Estonian: Mainitud sümptomite ilmnedes teavitage sellest viivitamatult oma arsti; - kui märkate endal ükskõik millist kõrvaltoimet seoses mõtlemise, tuju või mäluga, siis teavitage sellest palun oma arsti; - öelge oma arstile, kui te saate keemiaravi;
English: Caution should be exercised when ziconotide is administered to patients who are receiving systemic chemotherapy (see section 4.4).
Estonian: Süsteemset keemiaravi saavatele patsientidele tuleb zikonotiidi manustada ettevaatusega (vt lõik 4.4).
English: No adverse effects on female reproduction and post-natal development in rats were seen at systemic exposures up to 2,300 times human exposures at the maximum recommended intrathecal dose.
Estonian: Inimesele soovitatud maksimaalsest intratekaalsest annusest kuni 2300 korda suurema annuse manustamisel ei täheldatud kahjulikku toimet emasloomade viljakusele ega postnataalsele arengule.
English: Gastrointestinal disorders nausea, vomiting diarrhoea, dry mouth, constipation, nausea aggravated, upper abdominal pain dyspepsia
Estonian: Seedetrakti häired iiveldus, oksendamine kõhulahtisus, suukuivus, kõhukinnisus, iivelduse ägenemine, ülakõhuvalu düspepsia
English: EU/1/04/302/002 - 2 ml solution for infusion.
Estonian: EU/1/04/302/002 - 2 ml infusioonilahus.
English: Psychiatric disorders confusional state anxiety, auditory hallucination, insomnia, agitation, disorientation, hallucination, visual hallucination, depression, paranoia, irritability, depression aggravated, nervousness, affect lability, mental status changes, anxiety aggravated, confusion aggravated delirium, psychotic disorder, suicidal ideation, suicide attempt, thought blocking, abnormal dreams, aggressiveness
Estonian: Psühhiaatrilised häired segasusseisund ärevus, kuulmishallutsina tsioonid, unetus, agiteeritus, orientatsioonihäir ed, hallutsinatsioonid nägemishallutsina tsioonid, depressioon, paranoia, ärrituvus, depressiooni süvenemine, närvilisus, meeleolu labiilsus, vaimse seisundi muutused, ärevuse süvenemine, segasuse süvenemine deliirium, psühhootilised häired, enesetapumõtted enesetapukatse, mõtte katkestus, ebatavalised unenäod, agressiivsus
English: 500 micrograms/5ml
Estonian: 500 mikrogrammi / 5 ml
English: Each vial contains 200 micrograms ziconotide (as acetate).
Estonian: Iga viaal sisaldab 200 mikrogrammi zikonotiidi (atsetaadina).
English: Caution should be exercised when ziconotide is administered to patients with impaired hepatic function.
Estonian: Neerufunktsiooni häirega patsientidele tuleb zikonotiidi manustada ettevaatlikult.
English: Ziconotide is contraindicated in combination with IT chemotherapy (see section 4.3).
Estonian: Zikonotiidi ja IT keemiaravi ei tohi koos kasutada (vt lõik 4.3).
English: Each ml contains 100 micrograms ziconotide (as acetate) Each vial contains 500 micrograms ziconotide (as acetate).
Estonian: Iga ml sisaldab 100 mikrogrammi/ml zikonotiidi (atsetaadina) Iga viaal sisaldab 100 mikrogrammi zikonotiidi (atsetaadina).
English: Each 1 ml vial contains 100 μg ziconotide (as acetate).
Estonian: Iga 1 ml viaal sisaldab 100 μg zikonotiidi (atsetaadina).
English: The solution is clear and colourless.
Estonian: Prialt on selge ja värvitu infusioonilahus (infusioon).
English: Prialt was stable for 60 days at 37°C in the Synchromed pump previously exposed to the medicinal product.
Estonian: Synchromed pumbas, millega oli eelnevalt manustatud ravimit, püsis Prialt 37°C juures stabiilsena 60 päeva.
English: Pregnancy
Estonian: Intratekaalne
English: General disorders and administration site conditions gait abnormal, asthenia fatigue, pyrexia, lethargy, oedema peripheral, rigors, fall, chest pain, feeling cold, pain, feeling jittery, pain exacerbated difficulty in walking
Estonian: Üldised häired ja manustamiskoha reaktsioonid kõnnakuhäired, asteenia väsimus, palavik, letargia, perifeersed tursed, treemor, kukkumine, valu rinnus, külmatunne, valud, pingesolek, valu ägenemine käimisraskused
English: NAME OF THE MEDICINAL PRODUCT Prialt 25 μg/ml solution for infusion ziconotide
Estonian: RAVIMPREPARAADI NIMETUS Prialt 25 μg/ml infusioonilahus zikonotiid
English: Each 20 ml vial contains 500 μg ziconotide (as acetate).
Estonian: Iga 20 ml viaal sisaldab 500 μg zikonotiidi (atsetaadina).
English: Each ml contains 100 micrograms ziconotide (as acetate).
Estonian: Iga ml sisaldab 100 mikrogrammi/ml zikonotiidi (atsetaadina).
English: If dilution is required, Prialt must be diluted aseptically with preservative-free sodium chloride 9 mg/ml (0.9%) solution for injection before use.
Estonian: Kui Prialti on vaja eelnevalt lahjendada, tuleb seda enne kasutamist teha aseptilistes tingimustes säilitusainevaba naatriumkloriidi 9 mg/ml (0,9%) süstelahusega.
English: Nervous system disorders dizziness, nystagmus, memory impairment, headache, somnolence dysarthria, amnesia, dysgeusia, tremor, balance impaired, ataxia, aphasia, burning sensation, sedation, paraesthesia, hypoaesthesia, disturbance in attenti on, speech disorder, areflexia, coordination abnorm al, dizziness postural, cognitive disorder, hyperaesthesia, hyporeflexia, ageusia, depressed level of consciousness, dysaesthesia, parosmia, mental impairment incoherence, loss of consciousness, coma, stupor, convulsions, cerebrovascular accident, encephalopathy
Estonian: Närvisüsteemi häired pearinglus, nüstagm, mäluhäired, peavalu, somnolentsus düsartria, amneesia, maitsehäired, treemor, tasakaaluhäired, ataksia, afaasia, põletustunne, sedatsioon, paresteesia, hüpasteesia, tähelepanuhäire d, kõnehäired, arefleksia, koordinatsiooni häired, posturaalne pearinglus, kognitiivsed häired, hüperesteesia, hüporefleksia, maitsetundetus, teadvuse taseme langus, tundehäired, parosmia, vaimse võimekuse langus inkoherentsus, teadvuse kadu, kooma, stuupor, krambid, aju veresoonkonna äge haigus, entsefalopaatia
English: NAME OF THE MEDICINAL PRODUCT Prialt 25 micrograms/ml solution for infusion
Estonian: RAVIMPREPARAADI NIMETUS Prialt 25 mikrogrammi/ml infusioonilahus
English: - One ml solution contains 100 micrograms ziconotide (as acetate).
Estonian: - Üks ml lahust sisaldab 100 mikrogrammi zikonotiidi (atsetaadina).
English: NAME OF THE MEDICINAL PRODUCT Prialt 100 micrograms/ml solution for infusion
Estonian: RAVIMPREPARAADI NIMETUS Prialt 100 mikrogrammi/ml infusioonilahus
English: Ear and labyrinth disorders vertigo, tinnitus
Estonian: Kõrva ja labürindi kahjustused vertiigo, tinnitus
English: The solution should not be used if discoloured or cloudy or if particulate matter is observed.
Estonian: Värvuselt muutunud, hägust või võõrosakestega lahust ei tohi kasutada.
English: Caution should be exercised when ziconotide is administered to patients with impaired renal function.
Estonian: Maksafunktsiooni häirega patsientidele tuleb zikonotiidi manustada ettevaatlikult.
English: Musculoskeletal and connective tissue disorders pain in limb, myalgia, muscle spasms, muscle cramp, muscle weakness, arthralgia, peripheral swelling rhabdomyolysis, myositis, back pain, muscle twitching, neck pain
Estonian: Lihas-skeleti ja sidekoe kahjustused jäsemevalu, lihasevalu, lihasespasmid, lihasekrambid, lihasnõrkus, liigesevalu, perifeersed tursed rabdomüolüüs, müosiit, seljavalu, lihastõmblused, kaelavalu
English: Infection of the blood stream, delirium (feeling of mental confusion), psychotic disorder (abnormal thinking and perceptions), thought disorders, abnormal dreams, incoherence (inability to make sense), loss of consciousness, stupor (unresponsive/difficult to arouse), stroke, encephalopathy (brain disorder), aggressiveness, abnormal heart rhythm, difficulty breathing, indigestion, rash, muscle inflammation, back pain, muscle twitching, neck pain, acute kidney failure, abnormal heart trace measurements (ECG), raised body temperature, difficulty walking.
Estonian: Aeg-ajalt (võib esineda 1 kuni 10 kasutajal 1000st) verenakkus, deliirium (vaimne segasusseisund), psüühiline häire (ebanormaalne mõtlemine ja tajud), mõtlemishäired, ebanormaalsed unenäod, võimetus end selgelt väljendada, teadvuse kaotus, tardumus (mittereageerivus / raskesti äratatavus), insult, entsefalopaatia (ajuhäire), agressiivsus, südame rütmihäired, raskendatud hingamine, seedehäire, lööve, lihasepõletik, seljavalu, lihastõmblused, kaelavalu, äge neerupuudulikkus, südame EKG kõrvalekalded, kehatemperatuuri tõus, käimisraskused.
English: Patients have experienced depressed levels of consciousness while receiving ziconotide.
Estonian: Zikonotiid on põhjustanud teadvuse taseme langust.
English: - The other ingredients (excipients) are methionine, sodium chloride, water for injections,
Estonian: - Teised koostisosad (abiained) on metioniin, naatriumkloriid, süstevesi, vesinikkloriidhape ja naatriumhüdroksiid.
English: NAME OF THE MEDICINAL PRODUCT Prialt 100 micrograms/ml solution for infusion ziconotide
Estonian: RAVIMPREPARAADI NIMETUS Prialt 100 mikrogrammi/ml infusioonilahus zikonotiid
English: NAME OF THE MEDICINAL PRODUCT Prialt 25 micrograms/ml solution for infusion ziconotide
Estonian: RAVIMPREPARAADI NIMETUS Prialt 25 mikrogrammi/ml infusioonilahus zikonotiid
English: Ziconotide (n = 112)
Estonian: Zikonotiid (n = 112) Platseebo (n = 108)
English: Risk of infection
Estonian: Infusioonilahus
English: Cognitive and neuropsychiatric adverse reactions are common in patients treated with ziconotide.
Estonian: Zikonotiidiga ravitavatel patsientidel esineb sageli tunnetuslikke ja neuropsühhiaatrilisi kõrvaltoimeid.
English: Renal and urinary disorders urinary retention, urinary hesitation, dysuria, urinary incontinence acute renal failure
Estonian: Neerude ja kuseteede häired kusepeetus, urineerimistakis tus, düsuuria, kusepidamatus äge neerupuudulikkus
English: In some patients who received intrathecal doses greater than the maximum recommended dose, exaggerated pharmacological effects, e.g., ataxia, nystagmus, dizziness, stupor, depressed level of consciousness, muscle spasms, confusional state, sedation, hypotension, aphasia, speech disorder, nausea and vomiting were observed.
Estonian: Muuhulgas tekkis ataksia, nüstagm, pearinglus, stuupor, teadvuse taseme langus, lihasespasmid, segasusseisund, sedatsioon, hüpotensioon, afaasia, kõnehäired, iiveldus ja oksendamine.
English: - Keep this leaflet.
Estonian: Mitte hoida sügavkülmas.
English: What Prialt looks like and contents of the pack Prialt is a solution for infusion (infusion).
Estonian: Kuidas Prialt välja näeb ja pakendi sisu
English: Metabolism and nutrition disorders appetite decreased, anorexia
Estonian: Ainevahetus- ja toitumishäired isulangus, isutus
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/302/001 - 1 ml solution for infusion.
Estonian: EU/1/04/302/001 - 1 ml infusioonilahus.
English: Hepatic impairment
Estonian: Südame häired kodade virvendus
English: In case of a need for long term treatment, monitoring may be necessary (as decided by your doctor).
Estonian: Kõrvaltoimete ravis võib annuse vajadusel langetada ükskõik millisele tasemele (sh võib infusiooni peatada).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/302/004 - 20 ml solution for infusion
Estonian: EU/1/04/302/004 - 20 ml infusioonilahus.
English: Each vial contains 100 micrograms ziconotide (as acetate).
Estonian: Iga viaal sisaldab 500 mikrogrammi zikonotiidi (atsetaadina).
English: 10 vials + 10 pre-filled syringes + 20 needles
Estonian: 10 viaali + 10 süstlit+ 20 nõela
English: _ _1 Neisseria meningitidis serogroup A polysaccharide* 5 micrograms Neisseria meningitidis serogroup C polysaccharide* 5 micrograms Neisseria meningitidis serogroup W-135 polysaccharide* 5 micrograms Neisseria meningitidis serogroup Y polysaccharide* 5 micrograms *conjugated to tetanus toxoid carrier protein 44 micrograms
Estonian: Neisseria meningitidis'e rühma W-135 polüsahhariidi*
English: 10 vials + 10 pre-filled syringes
Estonian: 10 viaali + 10 süstlit
English: 1 vial + 1 prefilled syringe + 2 needles
Estonian: 1 viaal + 1 süstel + 2 nõela
English: 1 vial + 1 prefilled syringe
Estonian: 1 viaal + 1 süstel
English: Ref.: EMEA/619504/2009 EMEA/H/C/1071
Estonian: Viide: EMEA/619511/2009 EMEA/H/C/1071
English: It is used on its own to treat patients with:
Estonian: Seda kasutatakse ainsa ravimina patsientidel, kellel on:
English: It is used after at least one other treatment has failed;
Estonian: Topotecan Tevat kasutatakse pärast seda, kui vähemalt üks muu ravikuur on ebaõnnestunud;
English: This is repeated every 21 days for six courses or until the disease gets worse.
Estonian: Seda korratakse iga 21 päeva järel, viies läbi 6 ravikuuri või jätkates ravi kuni haiguse süvenemiseni.
English: • metastatic cancer of the ovary (when the cancer has spread to other parts of the body).
Estonian: • metastaatiline munasarjavähk (vähk on levinud ka teistesse kehaosadesse).
English: Topotecan Teva is given as an infusion lasting 30 minutes every day for five days with a three-week interval between the start of each course.
Estonian: Topotecan Tevat manustatakse 30 minutit kestva infusioonina iga päev 5 päeva järjest, jättes ravikuuride alguse vahele 3-nädalase intervalli.
English: It is also used together with cisplatin (another anticancer medicine) to treat women with cervical cancer (cancer of the cervix), when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (stage IVB: the cancer has spread beyond the cervix).
Estonian: Topotecan Tevat kasutatakse ka koos tsisplatiiniga (samuti vähiravim) emakakaelavähi raviks naistel, kellel on vähk pärast kiiritusravi taastunud, ning samuti kaugelearenenud staadiumi korral (IVB staadium: vähk on levinud emakakaelast kaugemale).
English: Treatment with Topotecan Teva should only be given under the supervision of a doctor experienced in the use of chemotherapy.
Estonian: Ravi Topotecan Tevaga peab toimuma üksnes keemiaravi kasutamises kogenud arsti järelevalve all.
English: No additional studies were needed as Topotecan Teva is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Estonian: Lisauuringuid ei olnud vaja, sest Topotecan Teva on infusioonina manustatav geneeriline ravim, mis sisaldab sama toimeainet kui võrdlusravim Hycamtin.
English: Topotecan Teva also affects non-cancer cells, which causes side effects.
Estonian: Topotecan Teva mõjutab ka muid rakke peale vähirakkude ning see põhjustab kõrvalnähte.
English: When used with cisplatin in cervical cancer, Topotecan Teva is given on days 1, 2 and 3 (with cisplatin given on day 1).
Estonian: Koos tsisplatiiniga emakakaelavähi raviks kasutamisel manustatakse Topotecan Tevat infusioonina 1., 2. ja 3. päeval (manustades tsisplatiini 1. päeval).
English: Because Topotecan Teva is a generic medicine, the company has provided data from the published literature on topotecan.
Estonian: Et Topotecan Teva on geneeriline ravim, esitas ettevõte topotekaani kohta avaldatud kirjandusest pärinevaid andmeid.
English: The Committee recommended that Topotecan Teva be given marketing authorisation.
Estonian: Komitee soovitas anda Topotecan Tevale müügiloa.
English: The European Commission granted a marketing authorisation valid throughout the EU for Topotecan Teva to Teva Pharma B.V. on 21 September 2009.
Estonian: Euroopa Komisjon andis Topotecan Teva müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Teva Pharma B.V.
English: Because Topotecan Teva is a generic medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Estonian: Et Topotecan Teva on geneeriline ravim, peetakse ravimi kasulikkust ja riske samadeks mis võrdlusravimil.
English: The full EPAR for Topotecan Teva can be found here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Topotecan Teva kohta leiate siit.
English: This means that Topotecan Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Hycamtin.
Estonian: See tähendab, et Topotecan Teva on sarnane võrdlusravimiga Hycamtin, millel juba on Euroopa Liidus müügiluba.
English: Topotecan Teva is a concentrate that is made up into a solution for infusion (drip into a vein).
Estonian: Topotecan Teva on kontsentraat, millest valmistatakse infusioonilahus (veeni tilgutatav lahus).
English: Other information about Topotecan Teva:
Estonian: Muu teave Topotecan Teva kohta
English: What is Topotecan Teva?
Estonian: Mis on Topotecan Teva?
English: What are the benefit and risk of Topotecan Teva?
Estonian: Milles seisneb Topotecan Teva kasulikkus ja mis riskid Topotecan Tevaga kaasnevad?
English: Why has Topotecan Teva been approved?
Estonian: Miks Topotecan Teva heaks kiideti?
English: Topotecan Teva is a ‘generic medicine'.
Estonian: Topotecan Teva on geneeriline ravim.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Topotecan Teva has been shown to be comparable to Hycamtin.
Estonian: Inimravimite komitee otsustas, et Topotecan Teva bioekvivalentsus Hycamtiniga on Euroopa Liidu nõuete kohaselt tõendatud.
English: Therefore, the CHMP's view was that, as for Hycamtin, the benefit outweighs the identified risk.
Estonian: Seetõttu leidis inimravimite komitee, et nagu ka Hycamtini puhul, ületab Topotecan Teva kasulikkus sellega kaasnevad riskid.
English: The active substance in Topotecan Teva, topotecan, is an anticancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Estonian: Topotecan Teva toimeaine topotekaan on topoisomeraasiinhibiitorite rühma kuuluv vähiravim.
English: The dose of Topotecan Teva to be used depends on the type of cancer that it is being used to treat and the patient's weight and height.
Estonian: Topotecan Teva annus sõltub ravitavast vähiliigist ning patsiendi kaalust ja pikkusest.
English: How has Topotecan Teva been studied?
Estonian: Kuidas Topotecan Tevat uuriti?
English: Topotecan Teva is an anticancer medicine.
Estonian: Topotecan Teva on vähiravim.
English: Topotecan Teva topotecan EPAR summary for the public
Estonian: Topotecan Teva topotekaan
English: How is Topotecan Teva used?
Estonian: Kuidas Topotecan Tevat kasutatakse?
English: What is Topotecan Teva used for?
Estonian: Milleks Topotecan Tevat kasutatakse?
English: How does Topotecan Teva work?
Estonian: Kuidas Topotecan Teva toimib?
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Estonian: I lisa Ravimi nimetuste nimekiri, ravimvorm, ravimpreparaadi tugevus, manustamisviis, müügiloa hoidjad liikmesriikides
English: Baxter Hungary Kft. Népfürdő u. 22.
Estonian: Baxter Hungary Kft. Népfürdö u. 22.
English: Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park,
Estonian: Edificio 10 Sintra Business Park,
English: 164 94 Kista
Estonian: 16494 Kista Sverige
English: 00-380 Warsawa, Poland
Estonian: Kruczkowskiego 8 st., 00-380 Warszawa, Poland
English: Baxter SPA piazzale dell' industria 2000144-Roma Italy
Estonian: Piazzale dell'Industria 20 00144 Roma Italy
English: Baxter Healthcare GmbH, Stella-KleinLöw-Weg 15, A1020 Wien, Austria
Estonian: Baxter Healthcare GmbH Stella-Klein-Löw-Weg 15, A-1020 Wien Austria
English: Denmark Baxter A/S, Gydevang 43, DK3450 Allerød,
Estonian: Baxter A/S Gydevang 43 3450 Allerød Denmark
English: Halandri, 152 33 Greece
Estonian: Diophar SA Kifissias 368 Halandri 15233 Greece
English: Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, Slovenia
Estonian: Sloveenia Baxter d.o.o., Zelezna cesta 18 ,Ljubljana, SI-1000, Slovenia
English: Annex I
Estonian: N/A
English: Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands
Estonian: 3542 CE Utrecht The Netherlands
English: B-7860 Lessines Belgium
Estonian: Boulevard R. Branquart 80 7680 Lessines Belgium
English: Norfolk IP24 3SE United Kingdom
Estonian: Thetford, Norfolk, IP24 3SE United Kingdom
English: 0.0051 % w/v
Estonian: 0,0184% w/v 0,0051% w/v
English: HEALTHCARE Ltd., Caxton Way, Thetford, Norfolk, 1P24 3SE, Thetford, United Kingdom
Estonian: Thetford, Norfolk, IP24 3SE, United Kingdom
English: Dianeal PD4 med Glucos 13,6 mg/ml
Estonian: Dianeal PD4 Glucose 13,6 mg/ml
English: 5.4 g / l 4.5 g / l 0.184 g / l
Estonian: 0.184 g/l
English: The standard dose of Clopidogrel Acino Pharma is one 75 mg tablet once a day, taken with or without food.
Estonian: Clopidogrel Acino Pharma tavaannus on üks 75 mg tablett üks kord ööpäevas koos toiduga või ilma.
English: Clopidogrel Acino Pharma clopidogrel EPAR summary for the public
Estonian: Clopidogrel Acino Pharma klopidogreel Kokkuvõte üldsusele
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Acino Pharma to Acino Pharma GmbH on 21 September 2009.
Estonian: Muu teave Clopidogrel Acino Pharma kohta Euroopa Komisjon andis Clopidogrel Acino Pharma müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Acino Pharma GmbH 21. septembril 2009.
English: Clopidogrel Acino Pharma can be given to the following groups of patients:
Estonian: Clopidogrel Acino Pharmat võib kasutada järgmiste patsiendirühmade korral:
English: Clopidogrel Acino Pharma can be started between seven days and six months after the stroke;
Estonian: Clopidogrel Acino Pharma manustamist võib alustada seitsme päeva kuni kuue kuu jooksul pärast insulti;
English: This means that Clopidogrel Acino Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Estonian: See tähendab, et Clopidogrel Acino Pharma on sarnane võrdlusravimiga Plavix, millel juba on Euroopa Liidus müügiluba.
English: Because Clopidogrel Acino Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Estonian: Et Clopidogrel Acino Pharma on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: Clopidogrel Acino Pharma is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Estonian: Clopidogrel Acino Pharmat kasutatakse aterotrombootiliste nähtude (trombide ehk soonesiseste verehüüvete moodustumisest ja arterite lubjastumisest põhjustatud probleemide) ennetamiseks täiskasvanutel.
English: The Committee recommended that Clopidogrel Acino Pharma be given marketing authorisation.
Estonian: Komitee soovitas anda Clopidogrel Acino Pharmale müügiloa.