FrancophonIA/ELRC3.0 huggingface dataset:
English: Cortacare is a corticosteroid veterinary medicine used to treat inflamed and itchy skin conditions in dogs.
Estonian: Cortacare on kortikosteroidist veterinaarravim, mida kasutatakse koerte põletikuliste ja sügelusega nahaseisundite raviks.
English: The hydrocortisone in Cortacare is in a special chemical form (di-ester) so the medicine is able to get into the outer layer of the skin and remain there for longer.
Estonian: Ravimis Cortacare sisalduv hüdrokortisoon on sellises keemilises vormis (diester), mis võimaldab ravimil tungida naha väliskihti ja püsida seal pikema aja vältel.
English: The active substance in Cortacare, hydrocortisone aceponate, is a corticosteroid or ‘steroid' which acts in the skin cells by stopping the release of chemicals which are involved in inflammation.
Estonian: Cortacare toimeaine hüdrokortisoonatseponaat on kortikosteroid ehk steroid, mis toimib naharakkudes, peatades põletiku tekkes osalevate keemiliste ainete vabanemise.
English: For more information about using Cortacare, see the package leaflet or contact your veterinarian or pharmacist.
Estonian: Kui vajate ravimiga Cortacare toimuva ravi kohta lisateavet, lugege palun pakendi infolehte või pöörduge oma veterinaararsti või apteekri poole.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Cortacare, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Estonian: Ravimi omaduste kokkuvõttesse ja pakendi infolehele lisati Cortacare ohutusteave, kus on ka tervishoiuspetsialistide ja loomaomanike või -pidajate võetavad meetmed.
English: Cortacare is a ‘hybrid medicine'.
Estonian: Cortacare on hübriidravim.
English: This means that it is similar to a ‘reference medicine' containing the same active substance.
Estonian: See tähendab, et Cortacare on sarnane võrdlusravimiga, mis sisaldab sama toimeainet.
English: It contains the active substance hydrocortisone aceponate.
Estonian: Ravim sisaldab toimeainena hüdrokortisoonatseponaati.
English: Two sprays is sufficient to treat an area of skin 10 cm by 10 cm. Care should be taken to avoid spraying the eyes of the dog.
Estonian: Kahest pihustuskorrast piisab 10×10 cm suuruse nahapiirkonna raviks.
English: What are the benefits and risks of Cortacare?
Estonian: Milles seisneb Cortacare kasulikkus ja mis riskid ravimiga kaasnevad?
English: This makes the medicine more effective at low doses in skin conditions.
Estonian: Selle tulemusena on ravim nahaseisundite ravis efektiivsem väikestes annustes.
English: composition of Cortacare is the same as the reference medicine and when sprayed onto the skin, the active substance in both products is expected to be absorbed in the same way.
Estonian: Seda ei olnud vaja, sest Cortacare koostis on sama kui võrdlusravimil ja nahale pihustamisel on toimeaine eeldatav imendumine mõlemal ravimil ühesugune.
English: There was no need for ‘bioequivalence' studies to investigate whether Cortacare is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Estonian: Bioekvivalentsust, st kas Cortacare imendub organismis samamoodi kui võrdlusravim, et saavutada toimeaine sarnane sisaldus veres, ei olnud vaja uurida.
English: How is Cortacare used?
Estonian: Kuidas Cortacaret kasutatakse?
English: Why is Cortacare authorised in the EU?
Estonian: Cortacare Euroopa Liidus heakskiitmise põhjused
English: Cortacare is available as a spray and can only be obtained with a prescription.
Estonian: Cortacaret turustatakse spreina ja see on retseptiravim.
English: The reference medicine for Cortacare is Cortavance.
Estonian: Cortacare võrdlusravim on Cortavance.
English: The precautions are the same as for the reference medicine since Cortacare is a hybrid medicine.
Estonian: Kuna Cortacare on hübriidravim, siis on meetmed samad mis võrdlusravimi korral.
English: How does Cortacare work?
Estonian: Kuidas Cortacare toimib?
English: Ref. EMEA/727640/2009 EMEA/H/C/1057
Estonian: London, 19. november 2009 Viide: EMA/727640/2009 EMEA/H/C/1057
English: What is Mersarex?
Estonian: Mis on Mersarex?
English: The main measure of effectiveness was the number of patients who were cured.
Estonian: Efektiivsuse põhinäitaja oli tervenenud patsientide arv.
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to issue a decision on this opinion.
Estonian: Pärast komitee arvamuse andmist kulub Euroopa Komisjonil arvamuse kohta otsuse tegemiseks ligikaudu kaks kuud.
English: The company presented results from two main studies involving 991 adults with complicated infections of the skin and soft tissues.
Estonian: Ettevõte esitas kahe põhiuuringu tulemused, milles osales 991 naha ja pehmekudede tüsistunud nakkustega täiskasvanut.
English: There were also concerns that the medicine may cause side effects affecting the heart (such as QTc interval prolongation, an alteration of the electrical activity of the heart) and the liver.
Estonian: Ettevaatlikkust tekitas ka asjaolu, et ravim võib põhjustada kõrvalnähtusid, mis mõjutavad südant (nagu QTc-intervalli pikenemine, südame elektrilise aktiivsuse muutus) ja maksa.
English: Complicated means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Estonian: „Tüsistunud“ tähendab, et nakkust on raske ravida, sest see on kas levinud sügavale nahaalustesse kudedesse, vaja võib olla kirurgilist ravi või patsiendil on muu haigus, mis võib ravivastust mõjutada.
English: Around half of the patients were treated with Mersarex, while the others were treated with linezolid (another antibiotic).
Estonian: Umbes pooled patsientidest said ravi Mersarexiga, ülejäänud aga linesoliidiga (samuti antibiootikum).
English: The letter from the company notifying the CHMP of the withdrawal of the application is available here.
Estonian: Ettevõtte kiri, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, on avaldatud siin.
English: The study looked at whether Mersarex given for up to 14 days was as good as linezolid.
Estonian: Uuringus jälgiti, kas kuni 14 päeva jooksul manustatud Mersarex oli sama efektiivne kui linesoliid.
English: The CHMP also noted that some bacteria already show a level of resistance to the antibiotic even before it is in general use.
Estonian: Inimravimite komitee märkis ka, et juba enne ravimi üldkasutusse võtmist on täheldatud teatud bakteritüvede osalist resistentsust antibiootikumi suhtes.
English: The application was at day 181 when the company withdrew.
Estonian: Taotluse menetlemine oli kestnud 180 päeva, kui ettevõte võttis taotluse tagasi.
English: By blocking the action of dihydrofolate reductase, the medicine was expected to slow down the growth and spread of the bacteria.
Estonian: Eeldati, et dihüdrofolaadi reduktaasi toime blokeerimisega aeglustab ravim bakterite kasvu ja levikut.
English: The CHMP was of the opinion that the results did not show that Mersarex was as good as the comparator medicine and that there were insufficient data from clinical studies to justify the dosage proposed by the company.
Estonian: Inimravimite komitee arvas, et uuringutulemused ei tõendanud, et Mersarex on sama efektiivne kui võrdlusravim, ja et kliiniliste uuringute andmed ei olnud piisavad, et õigustada ettevõtte väljapakutud annuse kasutamist.
English: On 21 October 2009, Arpida A/S officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Mersarex, for the treatment of adults with complicated skin and soft tissue infections.
Estonian: oktoobril 2009 teatas Arpida A/S ametlikult inimravimite komiteele oma soovist võtta tagasi naha ja pehmekudede tüsistunud nakkuste raviks täiskasvanutel kasutada kavatsetud ravimi Mersarex müügiloa taotlus.
English: Bacteria need this protein to produce the active form of folic acid, which they need to multiply.
Estonian: Bakterid kasutavad seda valku paljunemiseks vajaliku foolhappe aktiivse vormi sünteesimiseks.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Mersarex?
Estonian: Kuidas mõjutab tagasivõtmine praegu Mersarexi kliinilistes uuringutes või eriloaga kasutamise programmides osalevaid patsiente?
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Mersarex could not have been approved for the treatment of complicated infections of the skin and the soft tissues.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi inimravimite komitee taotluse tagasivõtmise ajal põhjuseid ettevaatlikkuseks ning oli esialgsel seisukohal, et Mersarexile ei või anda naha ja pehmekudede tüsistunud nakkuste raviks müügiluba.
English: The active substance in Mersarex, iclaprim, is an antibiotic of the group ‘dihydrofolate reductase inhibitors'.
Estonian: Mersarexi toimeaine iklapriim on dihüdrofolaadi reduktaasi inhibiitorite rühma kuuluv antibiootikum.
English: The company informed the CHMP that there are no patients currently using Mersarex in clinical trials or compassionate use programmes.
Estonian: Ettevõte teatas inimravimite komiteele, et Mersarexi ei kasutata praegu üheski kliinilises uuringus ega eriloaga kasutamise programmis.
English: Mersarex is a concentrate for solution for infusion (drip into a vein).
Estonian: Mersarex on kontsentraat, millest valmistatakse infusioonilahus (veeni tilgutatav lahus).
English: Questions and answers on the withdrawal of the marketing authorisation application for Mersarex iclaprim
Estonian: Teave müügiloa taotluse tagasivõtmise kohta Mersarex iklapriim21.
English: It was expected to work by blocking the action of a bacterial protein called dihydrofolate reductase.
Estonian: Eeldati, et see blokeerib dihüdrofolaadi reduktaasi (bakterivalgu) toime.
English: The effects of Mersarex were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Mersarexi toimet muude katsetega.
English: Mersarex was expected to be used to treat complicated infections of the skin and the ‘soft tissues' below the skin.
Estonian: Mersarexi kavatseti kasutada naha ja nahaaluste pehmekudede tüsistunud nakkuste raviks.
English: What was Mersarex expected to be used for?
Estonian: Milleks kavatseti Mersarexi kasutada?
English: How was Mersarex expected to work?
Estonian: Milline on Mersarexi eeldatav toime?
English: It contains the active substance iclaprim.
Estonian: Ravim sisaldab toimeainena iklapriimi.
English: Treatment initiation pack: 14 tablets + 14 tablets + 14 tablets + 14 tablets
Estonian: Ravi stardipakend: 14 tabletti + 14 tabletti + 14 tabletti + 14 tabletti
English: 1 bottle + 1 measuring cup + 1 oral syringe + 1 adaptor
Estonian: 1 pudel + 1 mõõtetops + 1 suusüstal + 1 adapter
English: Oral use bottle (glass)
Estonian: 10 mg/ml Siirup pudel (klaas)
English: Pharmaceutical form
Estonian: Ravimi nimetus
English: Content Package size
Estonian: Ravimi nimetus Tugevus Ravimivorm Loomaliik Manustamisviis Pakend
English: Target species
Estonian: Tugevus Ravimivorm Loomaliik Manustamisviis Pakend
English: London, 21 August 2008 Doc.
Estonian: London, 21. august 2008 Dok.
English: Ref. EMEA/402553/2008
Estonian: viide EMEA/402553/2008
English: International non-proprietary name (INN): ketoprofen
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): ketoprofeen
English: The main measure of effectiveness was the change in the severity of pain after 12 weeks of treatment.
Estonian: Peamine tõhususe näitaja oli valu tugevuse muutus pärast 12-nädalast ravi.
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a license.
Estonian: Pärast komitee arvamust kulub Euroopa Komisjonil müügiloa andmiseks ligikaudu kaks kuud.
English: The effectiveness of Diractin was studied in one main study involving 866 patients with osteoarthritis of the knee.
Estonian: Diractini tõhusust uuriti ühes põhiuuringus, milles osales 866 põlve osteoartriidiga patsienti.
English: The study compared the effectiveness of three different doses of Diractin (25 mg, 50 mg and 100 mg twice a day) with that of placebo (a dummy treatment).
Estonian: Uuringus võrreldi Diractini kolme annuse (25 mg, 50 mg ja 100 mg kaks korda päevas) tõhusust platseebo (näiva ravimi) tõhususega.
English: What is Diractin?
Estonian: Mis on Diractin?
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that any benefits of Diractin did not outweigh the identified risks.
Estonian: Seepärast oli inimravimite komitee tagasivõtmise ajal arvamusel, et Diractini kasulikkus ei ületa tuvastatud riske.
English: It was to be available as a gel containing 22.9 mg of ketoprofen per gram of gel.
Estonian: Seda oleks turustatud geelina, mis sisaldab 22,9 mg ketoprofeeni ühe grammi geeli kohta.
English: On 23 July 2008, IDEA AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Diractin, for the treatment of the symptoms of inflammation and pain associated with osteoarthritis.
Estonian: 23. juulil 2008 teatas IDEA AG ametlikult inimravimite komiteele oma soovist võtta tagasi osteoartriidiga seotud põletikusümptomite ja valu raviks kasutada kavatsetud ravimi Diractin müügiloa taotlus.
English: The CHMP was concerned that the effectiveness of Diractin had not been sufficiently demonstrated in the single main study: compared with placebo, Diractin did not reduce pain levels to an extent that would be relevant for patients.
Estonian: Inimravimite komitee ettevaatlikkuse põhjuseks oli see, et ainus põhiuuring ei olnud Diractini tõhusust piisavalt tõendanud: võrreldes platseeboga ei vähendanud Diractin valu raskusastet patsientide jaoks olulisel määral.
English: In Diractin gel, the ketoprofen is contained in special, small, fatty particles (called ‘Transfersomes') that are expected to carry the ketoprofen through the skin and release it deep below the skin, where the inflammation in osteoarthritis occurs.
Estonian: Diractini geelis sisaldub ketoprofeen spetsiaalsetes väikestes rasvaosakestes („transfersoomides“), mis viivad ketoprofeeni eelduste kohaselt läbi naha ja vabastavad selle sügaval naha all, kus esineb osteoartriidi korral põletik.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Diractin?
Estonian: Kuidas mõjutab tagasivõtmine praegu Diractini kliinilistes uuringutes või eriloaga kasutamise programmides osalevaid patsiente?
English: By reducing the production of prostaglandins, Diractin is expected to reduce the inflammation and pain caused by osteoarthritis.
Estonian: Prostaglandiinide tootmise vähendamisel leevendab Diractin eelduste kohaselt osteoartriidi põhjustatud põletikku ja valu.
English: Diractin is a medicine that contains the active substance ketoprofen.
Estonian: Diractin sisaldab toimeainet ketoprofeeni.
English: Questions and answers on the withdrawal of the marketing application for Diractin
Estonian: Teave müügiloa taotluse tagasivõtmise kohta Diractin
English: No compassionate use programmes with Diractin are being conducted.
Estonian: Diractini eriloaga kasutamise programme läbi ei viida.
English: The effects of Diractin were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Diractini toimet muude katsetega.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Diractin
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi komitee taotluse tagasivõtmise ajal põhjuseid ettevaatlikkuseks ning oli esialgsel
English: What was Diractin expected to be used for?
Estonian: Milleks kavatseti Diractini kasutada?
English: Diractin was expected to be used to treat the symptoms of inflammation and pain associated with osteoarthritis (a condition that causes swelling and pain in the joints).
Estonian: Diractini kavatseti kasutada osteoartriidiga (seisund, mis põhjustab liigeste turset ja valu) seotud põletikusümptomite ja valu raviks.
English: How is Diractin expected to work?
Estonian: Milline on Diractini eeldatav toime?
English: It is expected to work by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process.
Estonian: See blokeerib prostaglandiine tootvat ensüümi tsüklooksügenaasi.
English: The active substance in Diractin, ketoprofen, is a non-steroidal anti-inflammatory drug (NSAID).
Estonian: Diractini toimeaine ketoprofeen on mittesteroidne põletikuvastane ravim (MSPVR).
English: could not have been approved for the treatment of the symptoms of inflammation and pain associated with osteoarthritis.
Estonian: arvamusel, et Diractinile ei või anda müügiluba kasutamiseks osteoartriidiga seotud põletikusümptomite ja valu ravis.
English: - if you are a child (less than 12 years old).
Estonian: − kui Te olete laps (noorem kui 12-aastane);
English: Date of first authorisation: 19 February 2009 Date of renewal: 19 February 2014
Estonian: Müügiloa esmase väljastamise kuupäev: 19. veebruar 2009 Müügiloa uuendamise kuupäev: 19. veebruar 2014
English: Not known (cannot be estimated from available data)
Estonian: - Teadmata (ei saa olemasolevate andmete põhjal hinnaguliselt määrata):
English: It is possible they may impair the effectiveness of this medicine or cause an immune system response.
Estonian: Need võivad kahjustada selle ravimi efektiivsust või põhjustada immuunsüsteemi reaktsiooni.
English: 4 vials:
Estonian: 4 viaali:
English: Opgenra is intended only for single use in each patient.
Estonian: Opgenra on mõeldud iga patsiendi puhul ühekordseks kasutamiseks.
English: Not surprisingly, the antibody peak concentration was higher after the second exposure.
Estonian: Ei olnud üllatav, et antikehade tippkontsentratsioon oli kõrgem pärast teist kokkupuudet.
English: It has been observed following use (see section 4.8).
Estonian: Seda on täheldatud pärast kasutamist (vt lõik 4.8).
English: Indeed, there has been a limited exposure due to a recent and limited marketing of the product (launched in the EU only in August 2011 and marketed in only few Member States).
Estonian: Ravimi hiljutise ja piiratud turustamise tõttu on kokkupuude olnud piiratud (ravim tuli EL-is turule alles 2011. aasta augustis ja seda turustati ainult mõnes liikmesriigis).
English: Tell your doctor if you are taking or have recently taken any other medicines.
Estonian: Teatage oma arstile, kui Te kasutate või olete hiljuti kasutanud mis tahes muid ravimeid.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000), not known (cannot be estimated from the available data).
Estonian: väga sage (≥1/10); sage (≥1/100 kuni <1/10); aeg-ajalt (≥1/1000 kuni <1/100); harv (≥1/10 000 kuni <1/1000); väga harv (<1/10 000), ei ole teada (ei saa olemasolevate andmete põhjal hinnata).
English: Injury, poisoning and procedural complications
Estonian: Vigastus, mürgistus ja protseduurilised tüsistused
English: Other medicines and Opgenra
Estonian: Muud ravimid ja Opgenra
English: This should be considered in follow-up of patients with CT or X-ray.
Estonian: Seda tuleb arvestada patsientidel, kellel tehakse kontrolluuringuid KT või röntgeniga.
English: - if you are an adolescent (12-18 years old) or your skeleton is not yet be fully formed (you are still growing).
Estonian: − kui Te olete nooruk (12-18-aastane) võ Teie luustik ei ole veel täielikult välja arenenud (Te kasvate edasi).
English: The product should have a malleable, coherent putty-like consistency.
Estonian: Toode peaks olema painduva, sidusa kititaolise konsistentsiga.
English: The results of these showed no unanticipated or systemic effects of toxicity during the observation period and after administration.
Estonian: Nende tulemused ei näidanud mingeid soovimatuid või süsteemseid toksilisi toimeid jälgimisperioodil ja pärast manustamist.
English: The maximum dose of this medicine should not exceed 2 units (6.6 mg eptotermin alfa) since its effectiveness and safety in higher doses has not been studied.
Estonian: Opgenra maksimaalne doos ei tohiks ületada kaht ühikut (6,6 mg eptotermin alfa), sest selle efektiivsust ja ohutust suuremate dooside korral ei ole uuritud.
English: Use of Opgenra does not guarantee fusion; additional surgeries may be required.
Estonian: Opgenra kasutamine ei garanteeri spondülodeesi; võib vaja minna täiendavat kirurgilist sekkumist.
English: • product migration (this has been observed when the product was mixed with a synthetic product used to fill the bone void)
Estonian: • toote migreerumine (seda on täheldatud juhtudel, kus toodet segati sünteetilise tootega, et täita luuõõnsusi).
English: Do not breast-feed your baby during treatment with this medicine.
Estonian: Ärge toitke oma last rinnaga, kui ravi selle ravimiga.
English: Common: post-operative infection
Estonian: Sage: operatsioonijärgne infektsioon
English: Contents of the pack and other information What Opgenra contains
Estonian: Pakendi sisu ja muu teave Mida Opgenra sisaldab
English: The results of radiological and histological examinations in this study showed bone healing following the initial and repeat exposure in the same animal.
Estonian: Selle uuringu radioloogiliste ja histoloogiliste uuringute tulemused näitasid luu paranemist pärast implantaadiga esmast ja korduvat kokkupuudet samal loomal.
English: The frequency and severity of post-operative adverse events was similar in both test and control groups.
Estonian: Operatsioonijärgsete kõrvaltoimete sagedus ja tõsidus olid katse- ja kontrollgrupis sarnased.
English: Additional surgeries may be needed.
Estonian: Võite vajada täiendavat operatsiooni.
English: - Uncommon (may affect up to 1 in 100 people):
Estonian: - Aeg-ajalt (võib esineda kuni 1 inimesel 100st):
English: It is unlikely that Opgenra will affect the ability to drive and use machines
Estonian: On ebatõenäoline, et Opgenra mõjutab autojuhtimise ja masinatega töötamise võimet.
English: What Opgenra is and what it is used for.
Estonian: Mis ravim on Opgenra ja milleks seda kasutatakse
English: Pharmacotherapeutic group: Drugs for the treatment of bone diseases, bone morphogenetic proteins, ATC code: M05BC02
Estonian: Farmakoterapeutiline rühm: luuhaiguste ravimiseks mõeldud ravimid, luu morfogeneetilised valgud, ATC-kood: M05BC02
English: Significantly high titers of IgG class anti-OP-1 antibodies were detected in milk throughout the whole post-natal phase study until the lactation day 28 (see section 4.6).
Estonian: Märkimisväärselt kõrged Anti-OP-1 IgG-klassi antikehade tiitrid tuvastati rinnapiimas kogu postnataalse faasi uuringu jooksul kuni 28. imetamispäevani (vt lõik 4.6).
English: Place it subcutaneously if possible.
Estonian: Võimaluse korral asetage see subkutaanselt.
English: Do not use this medicine after the expiry date which is stated on the carton and blisters.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud pakendil ja blisteritel.
English: This effect, termed solid state carcinogenicity, has been frequently observed in rats in which solid materials (plastics or metals) were implanted subcutaneously.
Estonian: Seda toimet, monoliitset kartsinogeensust, on sageli täheldatud rottidel, kellele subkutaanselt implanteeriti tahkeid materjale (plasti või metalli).
English: The clinical significance of these antibodies is not known.
Estonian: Nende antikehade kliinilise tähtsuse kohta andmed puuduvad.