FrancophonIA/ELRC3.0 huggingface dataset:
English: This interferes with the activity of special channels on the cell surface called ‘sodium-dependent calcium channels' through which calcium ions normally enter the cells.
Estonian: See omakorda mõjutab rakukesta teatud kanaleid (naatriumist sõltuvaid kaltsiumikanaleid, mille kaudu kaltsiumiioonid tavaliselt rakku sisenevad), , vähendades sisenevate kaltsiumiioonide hulka.
English: Patients who take Ranexa must be given a ‘patient alert card' that summarises the key safety information on the medicine.
Estonian: Ranexat saavale patsiendile tuleb anda ka spetsiaalne hoiatuskaart, milles esitatakse ravimi ohutu kasutamise põhiteave.
English: Why has Ranexa been approved?
Estonian: Miks Ranexa heaks kiideti?
English: By reducing the flow of calcium into the cells, ranolazine is thought to help the heart to relax, improving blood flow to the heart muscle and relieving the symptoms of angina pectoris.
Estonian: südamelihasel lõdvestuda, parandades südamelihase verevarustust ja leevendades stenokardia sümptomeid.
English: The Committee decided that Ranexa's benefits are greater than its risks as an add-on treatment of the symptoms of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal medicines (such as beta-blockers and/or calcium antagonists).
Estonian: Komitee otsustas, et Ranexa kasulikkus on suurem kui riskid, kui seda kasutatakse lisaravimina nendel stabiilse stenokardiaga patsientidel, kelle haigus stenokardia põhiravimitega (nt beetablokaatorid ja/või kaltsiumi antagonistid) ei allu piisavalt ravile või kellel nimetatud ravimeid kasutada ei saa.
English: It is used as an add-on to existing treatment in patients whose disease is not adequately controlled by other medicines for angina pectoris, such as beta-blockers or calcium antagonists, or in patients who cannot take these medicines.
Estonian: Ravimit kasutatakse lisaravimina patsientidel, kelle haigus muude stenokardiaravimitega (nt beetablokaatorid või kaltsiumi antagonistid) ei allu piisavalt ravile, samuti neil patsientidel, kellel ei saa neid ravimeid kasutada.
English: The active substance in Ranexa, ranolazine, is thought to work by reducing the flow of sodium ions into the heart muscle cells.
Estonian: Ranexa toimeainet ranolasiini arvatakse toimivat sel viisil, et see vähendab naatriumiioonide sisenemist südamelihase rakkudesse.
English: What benefit has Ranexa shown during the studies?
Estonian: Milles seisneb uuringute põhjal Ranexa kasulikkus?
English: How is Ranexa used?
Estonian: Kuidas Ranexat kasutatakse?
English: What is Ranexa used for?
Estonian: Milleks Ranexat kasutatakse?
English: How has Ranexa been studied?
Estonian: Kuidas Ranexat uuriti?
English: This reduces the number of calcium ions that enter the cells.
Estonian: Vähendades kaltsiumi sisenemist rakkudesse, aitab ranolasiin arvatavasti
English: How does Ranexa work?
Estonian: Kuidas Ranexa toimib?
English: Prazitel Plus was first launched in the EU market in May 2009.
Estonian: Prazitel Plus toodi esimest korda ELi turule mais 2009.
English: INN/Strength
Estonian: INN/Tugevused
English: ATC vet code: QP52AA51
Estonian: ATC vet kood: QP52AA51
English: To be completed nationally.
Estonian: Täidetakse riiklikult
English: Member State EU/EEA
Estonian: Liikmesriik Eü/EMP
English: It is excreted within 24 hours to more than 95% of the administered dosage.
Estonian: 24 tunni jooksul eritub enam kui 95% manustatud doosist.
English: Since first marketing, the product has been shown to be well tolerated (very few reports of adverse effects) and there have been no reports of suspected lack of expected efficacy.
Estonian: Alates turustamise algusest on ravim osutunud hästi talutavaks (väga vähe kõrvalnähtude teateid) ning oletatavast efektiivsuse puudumisest ei ole olnud ühtki teadet kohta.
English: This conclusion is in line with the view taken during the various mutual recognition procedures (IE/V/0241-0243/001/MR).
Estonian: See järeldus on kooskõlas seisukohaga, mis võeti mitmes vastastikuse tunnustamise menetluses (IE/V/0241-0243/001/MR).
English: The product contains three active substances, as follows:
Estonian: Preparaat sisaldab kolme toimeainet:
English: In addition, a number of the target parasites have the potential to infect humans (zoonotic potential).
Estonian: Lisaks on mitmetel parasiitidel võime nakatada inimesi (zoonootiline võime).
English: The overall benefit - risk balance is considered positive.
Estonian: Üldist kasulikkuse ja riski suhet peetakse positiivseks.
English: The parasite dies upon exhaustion of its energy reserves, which occurs 2 - 3 days later.
Estonian: Parasiit sureb energiavarude ammendumise tõttu 2 - 3 päeva jooksul.
English: It is considered that the claimed efficacy of the product has been adequately substantiated.
Estonian: Leitakse, et ravimi väidetav efektiivsus on piisavalt hästi põhjendatud.
English: The reference product is authorised for use from two weeks of age with no specific risk identified for this particular age group.
Estonian: Võrdlusravimi kasutamine on lubatud alates teisest elunädalast ilma spetsiifilise riskita sellele vanuserühmale.
English: After absorption, the drug is distributed to all organs.
Estonian: Pärast imendumist jaotub see kõikides organites.
English: {BLISTER FOIL TEXT}
Estonian: { BLISTERPAKENDI TEKST }
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Estonian: MÜÜGI, TARNIMISE JA/VÕI KASUTAMISE KEELD
English: Excipients: For a full list of excipients, see section 6.1.
Estonian: Abiainete terviklik loetelu on esitatud punktis 6.1.
English: Therefore, it can be assumed that the concerned product is unlikely to present any greater risk to the target animal relative to that posed by the reference product.
Estonian: Seega võib eeldada, et asjaomase ravimiga ei kaasne sihtloomale tõenäoliselt suuremat riski kui see, mis on võrdlusravimil.
English: Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
Estonian: Parasiitide resistentsus ükskõik millise klassi antihelmintikumide suhtes võib välja kujuneda selle klassi ainete sagedaste, korduvate kasutamiste järel.
English: Concurrent use with other cholinergic compounds can lead to toxicity.
Estonian: Samaaegne kasutamine teiste koliinergiliste ühenditega võib põhjustada toksilisust.
English: Direct benefits
Estonian: Otsene kasulikkus
English: Appropriate user safety advice is included in the product literature.
Estonian: Asjakohased ohutusnõuanded kasutajale on esitatud ravimi dokumentides.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration marketing authorisation holder in the Member States.
Estonian: Veterinaarravimite nimetuste, ravimivormide ja tugevuste ning loomaliikide, manustamisviis, liikmesriikides müügiloa hoidjate loetelu.
English: The products are not expected to pose a risk to the environment.
Estonian: Ravim ei kujuta ohtu keskkonnale.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years Discard any unused divided tablets.
Estonian: Müügipakendis veterinaarravimi kõlblikkusaeg: 3 aastat Kasutamata jäänud jagatud tabletid tuleb ära visata.
English: It is recommended that the product is not used in dogs during the first 4 weeks of pregnancy.
Estonian: Soovitatav on seda preparaati koertel esimese 4 tiinusnädala jooksul mitte kasutada.
English: Based on the findings of this study, the test and reference products can be considered equivalent with respect to AUCinf of praziquantel; therefore similar systemic availability can be assumed.
Estonian: Selle uuringu tulemuste põhjal võib uuritavad ja võrdlusravimid lugeda prasikvanteeli AUCinf alusel samaväärseks ning eeldada võib sarnast süsteemset saadavust.
English: 2, 4, 6, 8 tablets.
Estonian: 2, 4, 6, 8 tabletti.
English: Febantel is absorbed relatively rapidly and metabolized to a number of metabolites including fenbendazole and oxfendazole, which have anthelmintic activity.
Estonian: Febanteel imendub suhteliselt kiiresti ja metaboliseerub mitmeteks metaboliitideks, sealhulgas fenbendasooliks ja oksfendasooliks, millel on anthelmintiline toime.
English: Both in vitro and in vivo studies have shown that praziquantel causes severe damage to the parasite integument, resulting in the contraction and paralysis of the parasites.
Estonian: Nii in vitro kui in vivo uuringud on näidanud, et prasikvanteel kahjustab parasiidi integumenti, mis põhjustab parasiitide kontraktsiooni ja paralüüsi.
English: The target parasites have the potential to impact on welfare of individual infected animals.
Estonian: Sihtparasiitidel on võime mõjutada nakatunud loomade üldseisundit.
English: The product is not expected to pose a risk to the user when used in accordance with label recommendations.
Estonian: Ravim ei ole kasutajale ohtlik, kui seda kasutatakse etiketil märgitud juhiste kohaselt.
English: No studies have been performed in dogs during early pregnancy.
Estonian: Koertel ei ole tiinuse algperioodil uuringuid tehtud.
English: To ensure administration of a correct dose, body weight should be determined as accurately as possible
Estonian: Õige doosi manustamise tagamiseks tuleb kehamass määrata võimalikult täpselt.
English: No starvation is needed before or after treatment.
Estonian: Näljutamine enne ja pärast ravi ei ole vajalik.
English: If there is a risk for re-infestation, the advice of a veterinarian should be sought regarding the need for and the frequency of repeat administration.
Estonian: Taasnakatumise ohu korral küsida nõu veterinaararstilt ravimi korduva manustamise vajaduse ja sageduse kohta.
English: • the CVMP reviewed the summary of products characteristics, labelling and package leaflet proposed by the marketing authorisation holder and considered all the overall submitted data;
Estonian: • veterinaarravimite komitee vaatas läbi müügiloa hoidja esitatud ravimi omaduste kokkuvõtte, märgistuse ja pakendi infolehe ning kaalus kõiki esitatud andmeid,
English: Do not use simultaneously with piperazine compounds.
Estonian: Mitte kasutada samaaegselt piperasiini sisaldavate preparaatidega.
English: There is extensive literature for the individual active substances and the combination which supports the safety of this product in younger puppies.
Estonian: Üksikute toimeainete ja kombinatsioonide kohta on olemas rohkelt kirjandust, mis toetab ravimi ohutust nooremate kutsikate ravis.
English: These in vitro data confirm that, under the conditions tested, the dissolution profiles are similar for both products.
Estonian: Need in vitro andmed kinnitavad, et uurimistingimustes on mõlema ravimi lahustuvusprofiilid sarnased.
English: Pharmacotherapeutic group: Anthelmintic, praziquantel combinations.
Estonian: Farmakoterapeutiline rühm: Anthelmintikumid, prasikvanteeli kombinatsioonid.
English: Tapeworm infestation is unlikely in pups less than 6 weeks of age.
Estonian: Paelussi infestatsioon on ebatõenäoline alla 6 nädala vanustel kutsikatel.
English: While the tolerance study was not performed on puppies less than 9 weeks of age, there is no reason to expect that this product presents an unacceptable risk to younger puppies.
Estonian: Ehkki taluvusuuringut ei tehtud alla 9 nädala vanustel kutsikatel, ei ole põhjust arvata, et noorematel kutsikatel on ravim lubamatu riskiga .
English: There is an almost instantaneous tetanic contraction of the parasite musculature and a rapid vacuolization of the syncytial tegument.
Estonian: Praktiliselt koheselt tekivad parasiidi muskulatuuri tetaaniline kontraktsioon ja süntsütiaalse tegumendi vakuolisatsioon.
English: Therefore, use of the product to eliminate the target parasites will benefit both the treated animal and public health.
Estonian: Seega on nende parasiitide hävitamine asjaomase ravimiga kasulik mitte ainult loomade, vaid inimeste tervisele.
English: Praziquantel is very rapidly absorbed through the parasite's surface and distributed throughout the parasite.
Estonian: Prasikvanteel imendub väga kiiresti läbi parasiidi pinna ja jaotub kogu parasiidis.
English: Discussion of the data available
Estonian: Olemasolevate andmete arutelu
English: Febantel, a probenzimidazole
Estonian: Febanteel - probensimidasool
English: This rapid contraction has been explained by changes in divalent cation fluxes, especially calcium.
Estonian: Seda kiiret kontraktsiooni on seletatud bivalentsete katioonide, eriti kaltsiumi vooludega.
English: While plasma concentrations are not a direct measure of the concentrations of active available locally in the gastro intestinal tract, it is considered that similar systemic availability (similar extent of absorption) is indicative of similar behaviour locally in the gastro intestinal tract following product administration.
Estonian: Kuigi plasmakontsentratsiooni põhjal ei saa vahetult mõõta toimeaine kontsentratsiooni seedetraktis, võib arvata, et sarnane süsteemne saadavus (sarnane imendumise määr) viitab sarnasele paiksele saadavusele seedetraktis pärast ravimi manustamist.
English: Following administration of the product to dogs, peak plasma concentrations of fenbendazole and oxfendazole were achieved by approximately 7-9 hours.
Estonian: Pärast manustamist koertele saavutati fenbendasooli ja oksfendasooli tippkontsentratsioon plasmas umbes 7-9 tunniga.
English: This combination shows synergistic activity in the case of hookworms and febantel is effective against T. vulpis.
Estonian: Kombinatsioonil on sünergiline toime kidausside vastu ja febanteel on efektiivne T. vulpis'e vastu.
English: The aim of the referral is to resolve divergences between the SPCs for the above mentioned products and thus to harmonise the different SPCs across the EU.
Estonian: Esildise eesmärk on kaotada lahknevused ülalnimetatud ravimite ravimi omaduste kokkuvõtetes ning seega ühtlustada ravimi omaduste kokkuvõtteid kogu ELis.
English: The tablets can be divided into equal halves or equal quarters.
Estonian: Helekollane tablett ristiga poolitusjoonega ühel poolel Tablette saab jagada võrdseteks poolteks või veeranditeks.
English: Do not use simultaneously with piperazine compounds as the anthelmintic effects of pyrantel and piperazine may be antagonized.
Estonian: Mitte kasutada samaaegselt piperasiini sisaldavate preparaatidega, kuna püranteeli ja piperasiini anthelmintilised toimed võivad antagoniseeruda.
English: Following administration of the product to dogs, peak plasma concentrations of praziquantel were achieved by approximately 2.5 hours.
Estonian: Pärast preparaadi manustamist koertele saavutati prasikvanteeli maksimaalne kontsentratsioon plasmas umbes 2,5 tunniga.
English: These data suggest that the test product is likely to be at least as effective as the reference product.
Estonian: Need andmed näitavad, et uuritav ravim on tõenäoliselt sama efektiivne kui võrdlusravim.
English: 1 tablet per 10 kg
Estonian: 1 tablett 10 kg kohta
English: This is equivalent to 1 tablet per 10 kg (22 lbs) bodyweight.
Estonian: See vastab ühele tabletile 10 kg (22 lbs) kehamassi kohta.
English: Following absorption, pyrantel pamoate is quickly and almost completely metabolized into inactive metabolites that are excreted rapidly in the urine.
Estonian: Pärast imendumist metaboliseerub püranteelpamoaat kiiresti ja peaaegu täielikult inaktiivseteks metaboliitideks, mis erituvad kiiresti uriiniga.
English: In addition the Chanelle Pharmaceuticals Manufacturing Ltd.was requested to provide a proposal for harmonised product information and supportive data for the harmonised product information.
Estonian: Peale selle paluti ettevõttel Chanelle Pharmaceuticals Manufacturing Ltd. esitada ettepanek ravimiteabe ühtlustamiseks ja seda toetav teave.
English: Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet
Estonian: Teaduslikud järeldused ning ravimi omaduste kokkuvõtte, pakendi märgistuse ja pakendi infolehe muutmise alused
English: Praziquantel acts against all adult and immature forms of these parasites.
Estonian: Prasikvanteel toimib nende parasiitide kõikide täiskasvanud ja noorvormide vastu.
English: Pyrantel acts as a cholinergic agonist.
Estonian: Püranteel toimib kolinergilise agonistina.
English: The main difference between the SPCs for the products relates to the claim regarding efficacy against Echinococcus granulosus and Echinococcus multilocularis and use of the product in pups less than 9 weeks of age and dogs weighing less than 2.5 kg.
Estonian: Asjaomaste ravimi omaduste kokkuvõtete peamised erinevused on seotud Echinococcus granulosus'e ja Echinococcus multilocularis'e vastase efektiivsuse väidetega ning ravimi kasutamisega alla 9-nädalastel kutsikatel ja alla 2,5 kg kaaluvatel koertel.
English: Based on the totality of information presented, it is considered that the efficacy of the concerned product will be similar to that of the reference product, Drontal Plus.
Estonian: Kogu esitatud teabele tuginedes leiti, et asjaomase ravimi efektiivsus on sarnane võrdlusravimi Drontal Plusi efektiivsusega.
English: Individual strips composed of aluminium foil 30 µm/30 gsm extruded polythene, containing 2, 4, 6, 8, 10, 12, 14, 16, 18 or 20 tablets.
Estonian: 30 µm alumiiniumfooliumist ja 30 gsm ekstrudeeritud polüteenist ribapakendid sisaldavad 2, 4, 6, 8, 10, 12, 14, 16, 18 või 20 tabletti või
English: The products are tablets for dogs containing praziquantel, pyrantel embonate and febantel and indicated for various parasitic infections.
Estonian: Ravimid on koertel kasutamiseks ettenähtud tabletid, mis sisaldavad prasikvanteeli, püranteelembonaati ja febanteeli ning on näidustatud erinevate parasiithaiguste raviks.
English: User Precautions:
Estonian: Erihoiatused kasutajale:
English: Use of the product during pregnancy should be in accordance with a benefit risk assessment by the responsible veterinarian.
Estonian: Tiinuse ajal kasutada ainult vastavalt vastutava loomaarsti tehtud kasu-riski suhte hinnangule.
English: In safety studies, a single dose of 5 times the recommended dose or greater gave rise to occasional vomiting.
Estonian: Ohutusuuringutes kutsus 5-kordsete ja suuremate dooside manustamine mõnikord esile oksendamist.
English: Formation of microtubules is thereby prevented, resulting in disruption of structures vital to the normal functioning of the helminth.
Estonian: Mikrotuubulite tekke pärssimise tõttu kahjustub helmindi normaalseks funktsioneerimiseks vajalike eluliste struktuuride moodustumine.
English: The spectrum of activity of praziquantel covers all important cestode species in dogs, in particular Taenia spp., Dipylidium caninum, Echinococcus granulosus and Echinococcus multilocularis.
Estonian: Prasikvanteeli toimespekter katab kõik olulised koertel esinevad paelussiliigid, eriti Taenia spp., Dipylidium caninum´i, Echinococcus granulosus´e ja Echinococcus multilocularis´e.
English: The CVMP requested Chanelle Pharmaceuticals Manufacturing Ltd.to justify the claim for efficacy against Echinococcus species and to provide all relevant data in support of the Echinococcus claim, which were presented previously in the dossiers submitted for marketing authorisation, together with comments on the suitability of the documentation to support the extrapolation of efficacy from the reference product to the hybrid product.
Estonian: Veterinaarravimite komitee palus ettevõttel Chanelle Pharmaceuticals Manufacturing Ltd. põhjendada Echinococcus'e liikide vastase efektiivsuse väidet ning esitada Echinococcus'e näidustuse toetuseks kõik vajalikud andmed, mis ta esitas müügiloa taotluse toimikutes, koos märkustega võrdlusravimi efektiivsuse hübriidravimile ülekandmist toetavate dokumentide sobivuse kohta.
English: While the majority of references cited by Chanelle Pharmaceuticals Manufacturing Ltd.reported on the efficacy of praziquantel when presented as a monosubstance tablet (Droncit, Bayer Animal Health), a number of the references reported on the efficacy of praziquantel when presented in other pharmaceutical forms (injectable, paste, powder) and/or for administration by other routes (intramuscular, subcutaneous) and/or when combined with other active substances (e.g. Drontal Plus, Bayer Animal Health).
Estonian: Kuigi enamik ettevõtte Chanelle Pharmaceuticals Manufacturing Ltd. viidatud allikaid tõendas prasikvanteeli efektiivsust ühe toimeainega tabletina (Droncit, Bayer Animal Health), teatasid mitmed allikad prasikvanteeli efektiivsusest ka muudes ravimvormides (süstevorm, pasta, pulber) ja/või teiste manustamisviisidena (intramuskulaarne, subkutaanne) ja/või kombineerituna teiste toimeainetega (nt Drontal Plus, Bayer Animal Health).
English: • the CVMP considered the in use of the products in puppies less than 9 weeks of age and dogs weighing less than 2.5 kg
Estonian: • veterinaarravimite komitee kaalus ravimite kasutamist alla 9 nädala vanustel kutsikatel ja alla 2,5 kg kaaluvatel koertel;
English: Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis of the nematodes and thereby allow removal from the gastrointestinal system by peristalsis.
Estonian: See stimuleerib parasiidi nikotiinergilisi kolinoretseptoreid, indutseerib nematoodide spastilist paralüüsi ja võimaldab seeläbi parasiitide eemaldamise seedesüsteemist peristaltikaga.
English: For Animal Treatment Only.
Estonian: Ainult veterinaarseks kasutamiseks.
English: The combination of praziquantel, pyrantel embonate and febantel is well tolerated in dogs.
Estonian: Prasikvanteeli, püranteelembonaadi ja febanteeli kombinatsioon on koerte poolt hästi talutav.
English: Tapeworm infestation is certain to reoccur unless control of intermediate hosts such as fleas, mice, etc. is undertaken.
Estonian: Nakatumine võib kindlasti korduda, kui vaheperemehi, nagu kirbud, hiired jne, ei hävitata.
English: Whipworms: Trichuris vulpis (adults).
Estonian: Piugussid: Trichuris vulpis (täiskasvanud vorm)
English: Do not use after expiry date stated on the label.
Estonian: Pärast etiketil märgitud kõlblikkusaja lõppu mitte kasutada.
English: Medicines should not be disposed of via wastewater or household waste.
Estonian: Kasutamata jäänud ravimeid ega jäätmematerjale ei tohi ära visata kanalisatsiooni kaudu ega koos majapidamisprügiga.
English: The products concerned are seven duplicates with identical hybrid application dossiers for which the reference product is Drontal Plus (Bayer Animal Health).
Estonian: Need on 7 duplikaatravimit, millel on identsed hübriidtaotluse toimikud ja mille võrdlusravim on Drontal Plus (Bayer Animal Health).
English: The Committee considered on basis of a target animal safety study that the use of the concerned product in puppies less than 9 weeks of age or dogs less than 2.5 kg is unlikely to give rise to a safety concern and therefore a restriction on use in such animals is unnecessary.
Estonian: Veterinaarravimite komitee leidis sihtloomade ohutusuuringu põhjal, et asjaomase ravimi kasutamine alla 9 nädala vanustel kutsikatel või alla 2,5 kg kaaluvatel koertel ei tekita tõenäoliselt ohutusprobleeme ning seetõttu ei ole kasutamispiirangud sellistel loomadel vajalikud.
English: Febantel
Estonian: Febanteel
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Estonian: TOIMEAINETE JA ABIAINETE SISALDUS
English: The tablets can be given directly to the dog or disguised in food.
Estonian: Tablette võib anda loomale otse suhu või segatuna toiduga.
English: The products have been formulated to have the same composition, in terms of active substances, as the authorised reference product and the proposed conditions of use of the products are identical to those of the reference product.
Estonian: Ravimi koostis on toimeainete osas sarnane müügiloa saanud võrdlusravimi koostisega ja soovitatud kasutustingimused on samasugused kui võrdlusravimil.
English: Benefit assessment
Estonian: Kasulikkuse hindamine
English: Further, it is considered that use of this product, in accordance with label recommendations in the product literature, sufficiently manages the risk associated with its use.
Estonian: Lisaks ollakse seisukohal, et ravimi kasutamisel sellele lisatud dokumentide kohaselt on riskid piisavalt hästi ohjatud.