FrancophonIA/ELRC3.0 huggingface dataset:
English: The mechanism of action of para-aminosalicylic acid resembles the sulfonamides, competing with paraminobenzoic acid (PABA) for dihydropteroate synthetase (DHP), a key enzyme in the biosynthesis of folates.
Estonian: Paraaminosalitsüülhappe toimemehhanism sarnaneb sulfoonamiidide mehhanismiga, konkureerides paraaminobensoehappega (PABA) dihüdropteroaadi süntetaasi (DHP), folaatide sünteesi põhiensüümi inhibeerimises.
English: GRANUPAS is not recommended during pregnancy and in women of childbearing potential not using contraception.
Estonian: GRANUPASt ei ole soovitav kasutada raseduse ajal ja fertiilses eas naistel, kes ei kasuta rasestumisvastaseid vahendeid.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON BOX
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED KARTONGIST KARP
English: Methacrylic acid - Ethyl acrylate copolymer (1:1) Dispersion 30 per cent Hypromellose
Estonian: Metakrüülhappe-etüülakrülaadi kopolümeeri (1 : 1) 30% dispersioon Hüpromelloos
English: The complete syndrome includes steatorrhoea, an abnormal small bowel pattern on x-ray, villus atrophy, depressed cholesterol, reduced D-xylose and iron absorption.
Estonian: Täielik sündroom sisaldab steatorröad, kõrvalekaldeid peensoole röntgenmustris, hattude atroofiat, kolesteroolisisalduse vähenemist, vähenenud D-ksüloosi ja raua imendumist.
English: The granules should not be crushed or chewed, as this impairs the gastro-resistant coating.
Estonian: Graanuleid ei tohi purustada ega närida, sest see kahjustab nende happekindlat katet.
English: Very rare Thrombocytopenia, purpura, leukopenia, anemia, methemoglobinemia, agranulocytosis.
Estonian: Trombotsütopeenia, purpur, leukopeenia, aneemia, methemoglobineemia, agranulotsütoos
English: 1244 RL Ankeveen The Netherlands
Estonian: 1244 RL Ankeveen Madalmaad
English: • Vitamin B12
Estonian: • B12-vitamiin,
English: The major metabolites of PAS are produced by conjugation to glycine in para-aminosalicyluric acid (PASU) for up to 25% of the dose and to N-acetyl in N-acetyl para-aminosalicylic acid (Ac-PAS) for up to 70% of the dose.
Estonian: Para-aminosalitsüülhappe peamised metaboliidid tekivad konjugeerimise teel: glütsiiniks paraaminosalitsüülkusihappes (PASU) kuni 25% ulatuses annusest ja N-atsetüüliks N-atsetüül-paraaminosalitsüülhappes (Ac-PAS) kuni 70% ulatuses annusest.
English: • Add the contents of the sachet to a drink of tomato or orange juice.
Estonian: • Lisage kotikese sisu klaasile tomati- või apelsinimahlale.
English: Mild to moderate renal impairment
Estonian: Kerge kuni mõõdukas neerukahjustus
English: In the rabbit, sodium aminosalicylate had no effects on embryofoetal development; however, the doses evaluated were below those proposed clinically.
Estonian: Küülikute embrüofetaalset arengut naatriumaminosalitsülaat ei mõjutanud, kuid hinnatud annused olid soovitatud kliinilistest annustest väiksemad.
English: Para-aminosalicylic acid is distributed in various tissues and fluids including the lungs, kidneys, liver and peritoneal fluid.
Estonian: Paraaminosalitsüülhape jaotub erinevates kudedes ja vedelikes, sealhulgas kopsudes, neerudes, maksas ja peritoneaalvedelikus.
English: Care must be taken in the administration of these granules to protect the acid-resistant coating by maintaining the granules in an acidic food during dosage administration.
Estonian: Graanulite manustamisel tuleb hoolikalt kaitsta nende happekindlat katet, hoides neid annuse manustamise ajal happelises toidus.
English: This medicinal product decreases the gastrointestinal absorption of para-aminosalicylic acid, and should not be administered concomitantly.
Estonian: See ravim vähendab paraaminosalitsüülhappe imendumist seedetraktist ja neid ei tohi koos manustada.
English: Gastro-resistant granules The granules are small off white/ light brown coloured approximately 1.5 mm diameter.
Estonian: Väikesed valkjad/helepruuni värvusega, ligikaudu 1,5 mm diameetriga graanulid.
English: Para-aminosalicylic acid has negligible influence on the ability to drive and use machines.
Estonian: Paraaminosalitsüülhape mõjutab ebaoluliselt autojuhtimise ja masinate käsitsemise võimet.
English: In a single dose study the plasma half-life of para-aminosalicylic acid administered as GRANUPAS was 1.62 ± 0.85 h.
Estonian: Üksikannuse uuringus oli paraaminosalitsüülhappena manustatud GRANUPAS plasma poolväärtusaeg 1,62 ±0,85 tundi.
English: Hypothyroidism*.
Estonian: Hüpotüreoidism*
English: Sodium aminosalicylic acid was not mutagenic in Ames test strain TA 100.
Estonian: Naatriumaminosalitsüülhape ei olnud Amesi testi tüves TA 100 mutageenne.
English: How to store GRANUPAS
Estonian: Kuidas GRANUPASt säilitada
English: This medicine is presented as light brown gastro-resistant granules in sachets.
Estonian: See ravim on helepruunide gastroresistentsete graanulitena kotikestes.
English: Para-aminosalicylic acid is acetylated in the liver and converted into the inactive metabolite, N-acetylpara-aminosalicylic acid which is devoid of bacteriostatic activity.
Estonian: Paraaminosalitsüülhape atsetüülitakse maksas ja konverteeritakse inaktiivseks metaboliidiks Natsetüülparaaminosalitsüülhappeks, millel puudub bakteriostaatiline aktiivsus.
English: Oral use.
Estonian: Suukaudne kasutamine.
English: o Tap the spoon once on a table to give a horizontal level of granules and continue filling if necessary.
Estonian: Võtke arsti määratud õige annus; o pange graanulid otse lusikasse; o koputage lusikat, et graanulite tase oleks horisontaalne, ja jätkake vajaduse korral lusika täitmist.
English: Ethionamide
Estonian: Etioonamiid
English: Para-aminosalicylic acid may be associated with an increased risk of hypothyroidism in HIV coinfected patients.
Estonian: Hüpotüreoos kaasuva HIV-infektsiooniga patsientidel Paraaminosalitsüülhapet võib kaasuva HIV-infektsiooniga patsientide puhul seostada suurenenud hüpotüreoosi riskiga.
English: The safety and efficacy of para-aminosalicylic acid in neonates have not been established.
Estonian: GRANUPAS ohutus ja efektiivsus vastsündinutel ei ole tõestatud.
English: Sachets consisting of paper/low density polyethylene/aluminium foil/primer/low density polyethylene.
Estonian: Kotikesed koosnevad paberist / väikese tihedusega polüetüleenist / alumiiniumfooliumist / aluskihist / väikese tihedusega polüetüleenist.
English: Blood and lymphatic system disorders
Estonian: Vere- ja lümfisüsteemi häired Väga harv
English: Your physician may need to start with a lower dose to prevent possible side effects.
Estonian: Võimalike kõrvaltoimete vältimiseks võib teie arst alustada ravi väiksema annusega.
English: Gastro-resistant granules 30 sachets
Estonian: Gastroresistentsed graanulid 30 kotikest
English: Do not use this medicine if you notice the sachets are swollen or if the granules are dark brown or purple.
Estonian: Ärge kasutage seda ravimit, kui kotike on paisunud või kui graanulid on tumepruunid või lillad.
English: Any granules left-over at the bottom of the glass should be swallowed immediately by adding a small quantity of liquid.
Estonian: Klaasi põhja jäänud graanulitele tuleb lisada väike kogus vedelikku ja need kohe alla neelata.
English: • Do not use the sachet if it is swollen or the granules have lost their light brown colour.
Estonian: • Ärge kasutage, kui kotike on paisunud või kui graanulid on kaotanud oma helepruuni värvuse.
English: Urticaria.
Estonian: Suukaudne.
English: Antiretrovirals
Estonian: Retroviirusvastased ravimid
English: Calibrated measuring spoon
Estonian: Kalibreeritud mõõtelusikas
English: Do not chew or crush.
Estonian: Ärge närige ega purustage.
English: If you are not sure, talk to your doctor or pharmacist before taking GRANUPAS.
Estonian: Kui te ei ole milleski kindel, pidage enne GRANUPASe võtmist nõu arsti või apteekriga.
English: Patients with severe renal disease will accumulate the inactive acetyl metabolite of paraaminosalicylic acid.
Estonian: Raske neeruhaigusega patsientidel akumuleerub paraaminosalitsüülhappe inaktiivne atsetüülmetaboliit.
English: Very rare side effects (may affect less than 1 in 10,000 people):
Estonian: Väga harva esinevad kõrvaltoimed (esinevad vähem kui 1 inimesel 10 000st):
English: An in vivo genotoxicity study (micronucleus test) has been conducted with para-aminosalicylic acid.
Estonian: Paraaminosalitsüülhappega viidi läbi in vivo genotoksilisuse uuring (pisituuma katse).
English: In case it does, please report it to your doctor or pharmacist.
Estonian: Juhul kui mõjutab, teavitage sellest kohe oma arsti või apteekrit.
English: Rare side effects (may affect more than 1 in 10,000 people):
Estonian: Harva esinevad kõrvaltoimed (võivad esineda enam kui 1 inimesel 10 000st):
English: Patients with severe renal impairment should not receive para-aminosalicylic acid.
Estonian: Raske neerukahjustusega patsiendid ei tohi paraaminosalitsüülhapet kasutada.
English: Common side effects (may affect more than 1 in 100 people):
Estonian: Sageli esinevad kõrvaltoimed (võivad esineda enam kui 1 inimesel 100st):
English: Para-aminosalicylic acid should be used with caution in patients with peptic ulcer.
Estonian: Paraaminosalitsüülhapet tuleb peptilise haavandiga patsientidel kasutada ettevaatusega.
English: • reduction in numbers of red blood cells,
Estonian: • punaste vererakkude arvu vähenemine,
English: Malabsorption syndrome*, peptic ulcer, gastrointestinal bleeding, jaundice, metallic taste.
Estonian: Malabsorptsioonisündroom*, peptiline haavand, mao-seedetrakti verejooks, ikterus, metallimaitse
English: Severe renal disease.
Estonian: Raske neeruhaigus.
English: Desensitization
Estonian: Desensibilisatsioon
English: Package leaflet: Information for the patient GRANUPAS 4 g gastro-resistant granules para-aminosalicylic acid
Estonian: Pakendi infoleht: teave patsiendile GRANUPAS 4 g gastroresistentsed graanulid paraaminosalitsüülhape
English: GRANUPAS 4 g gastro-resistant granules
Estonian: GRANUPAS 4 g gastroresistentsed graanulid
English: • giddiness,
Estonian: • iiveldus,
English: The first symptoms usually appear within three months of the start of therapy with a rash as the most common adverse reaction followed by fever and much less frequently by gastrointestinal disturbances of anorexia, nausea or diarrhoea.
Estonian: Kõige sagedam kõrvaltoime on lööve, millele lisandub palavik ja palju harvem esinevad anoreksia seedetrakti häired, iiveldus või kõhulahtisus.
English: The active substance is para-aminosalicylic acid.
Estonian: Toimeaine on paraaminosalitsüülhape.
English: • if you have a stomach ulcer
Estonian: • kui teil on maohaavand;
English: • reduction in numbers of white blood cells,
Estonian: • valgete vererakkude arvu vähenemine,
English: The sachet should not be used if it is swollen or if the granules have lost their light brown colour, and are turning dark brown or purple.
Estonian: Kotikest ei tohi kasutada, kui see on paisunud või kui graanulid on kaotanud oma helepruuni värvuse ja muutunud tumepruuniks või lillaks.
English: Each sachet of gastro-resistant granules contains 4 g of para-aminosalicylic acid.
Estonian: Üks gastroresistentsete graanulite kotike sisaldab 4 g paraaminosalitsüülhapet.
English: How to take GRANUPAS
Estonian: Kuidas GRANUPASt võtta
English: There are no or limited amount of data from the use of para-aminosalicylic acid in pregnant women.
Estonian: Paraaminosalitsüülhappe kasutamise kohta rasedatel andmed puuduvad või on piiratud hulgal.
English: Vitamin B12 absorption may be reduced by para-aminosalicylic acid with clinically significant erythrocyte abnormalities developing after depletion; patients on therapy of more than one month should be considered for maintenance of vitamin B12.
Estonian: Paraaminosalitsüülhape võib vähendada B12-vitamiini imendumist ja pärast selle varude ammendumist võivad tekkida kliiniliselt olulised erütrotsüütide kõrvalekalded.
English: Tabulated list of adverse reactions
Estonian: Tabel kõrvaltoimete loeteluga
English: Common abdominal pain, vomiting, nausea, bloating, diarrhea, soft stools.
Estonian: Kõhuvalu, oksendamine, iiveldus, kõhupuhitus, kõhulahtisus, pehme väljaheide
English: • metallic taste,
Estonian: • metallimaitse,
English: Very rare Tendon pain, headache, visual abnormalities,
Estonian: Väga harv Kõõlusvalu, peavalu, nägemishäired, perifeerne neuropaatia, pearinglus
English: Hepatic toxicity
Estonian: Hepatiit
English: There is no evidence available on the effect of para-aminosalicylic acid on fertility.
Estonian: Paraaminosalitsüülhappe toime kohta fertiilsusele ei ole tõendeid.
English: Each sachet contains 4 g of para-aminosalicylic acid.
Estonian: Üks kotike sisaldab 4 g paraaminosalitsüülhapet.
English: There is insufficient information on the effects of para-aminosalicylic acid in newborns/infants..
Estonian: Andmed paraaminosalitsüülhappe toimest vastsündinutele/imikutele on puudulikud.
English: Increased blood alkaline phosphatase, transaminases, weight loss.
Estonian: Protrombiinisisalduse vähenemine, hepatotsütolüüs, aluselise fosfataasi ja transaminaaside aktiivsuse suurenemine, kehakaalu langus
English: • skin redness or rash,
Estonian: • nahapunetus või lööve,
English: Para-aminosalicylic acid should be used with caution in patients with hepatic impairment.
Estonian: Paraaminosalitsüülhapet tuleb maksakahjustusega patsientidel kasutada ettevaatusega.
English: Gastric ulcer
Estonian: Gastroresistentsed graanulid.
English: • reduction in blood platelets,
Estonian: • vereliistakute arvu vähenemine,
English: • nausea,
Estonian: • pööritus,
English: Hypothyroidism in HIV co-infected patients is a very common event and occurs in ≥ 1/10 subjects, particularly when para-aminosalicylic acid is administered with ethionamide/prothionamide.
Estonian: Kaasuva HIV-infektsiooniga patsientidel on hüpotüreoos väga levinud ja seda esineb ≥1/10 patsiendil,
English: Ethionamide should be withdrawn if these effects are significant.
Estonian: Kui need toimed on olulise raskusega, tuleb ravi etioonamiidiga lõpetada.
English: Warning: Do not use if sachet is swollen or the granules have lost their light brown colour and are dark brown or purple
Estonian: Mitte kasutada, kui kotike on paisunud või kui graanulid on kaotanud oma helepruuni värvuse ja on tumepruunid või lillad.
English: GRANUPAS 4 g gastro-resistant granules para-aminosalicylic acid
Estonian: GRANUPAS 4 g gastroresistentsed graanulid paraaminosalitsüülhape Suukaudne
English: Diphenylhydramine
Estonian: Maohaavand
English: Serum digoxin levels should be monitored in patients on concomitant therapy.
Estonian: Kaasuvat ravi saavatel patsientidel tuleb jälgida seerumi digoksiinisisaldust.
English: • weight loss.
Estonian: • sügelev lööve.
English: • visual abnormalities,
Estonian: • madal veresuhkru sisaldus,
English: Common Cutaneous hypersensitivity, skin rash.
Estonian: Naha ülitundlikkus, nahalööve
English: Uncommon Anorexia.
Estonian: Anoreksia
English: • headache,
Estonian: • kõõlusvalu, peavalu,
English: Talk to your doctor or pharmacist before taking GRANUPAS
Estonian: Enne GRANUPASe võtmist pidage nõu oma arsti või apteekriga:
English: • destruction of liver cells
Estonian: • maksarakkude hävimine,
English: • tendon pain,
Estonian: • pearinglus,
English: Posology
Estonian: Urtikaaria
English: The small granules are designed to escape the restriction on gastric emptying of large particles.
Estonian: Graanulid on väikesed, et erinevalt suurtest osakestest läbida magu kiiremini.
English: Gastrointestinal disorders
Estonian: Difenüülhüdramiin
English: EU/1/17/1255/001
Estonian: EU/1/17/1255/001 Intrarosa
English: 28 pessaries + 6 applicators
Estonian: 28 vaginaalsuposiiti + 6 aplikaatorit
English: Vaginal use blister (PVC/PE)
Estonian: Blisterpakend (PVC/PE)
English: Intrarosa
Estonian: Vaginaalne
English: The full EPAR for Pantoloc Control can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Pantoloc Controli kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Pantoloc Control on 12 June 2009.
Estonian: Euroopa Komisjon andis Pantoloc Controli müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 12. juunil 2009.
English: It was also of the opinion that, based on the experience of the use of pantoprazole, the availability of Pantoloc Control without medical supervision is appropriate.
Estonian: Inimravimite komitee oli ka seisukohal, et pantoprasooli kasutamise kogemust arvestades on Pantoloc Controli kättesaadavus ilma arstliku järelevalveta asjakohane.
English: The recommended dose of Pantoloc Control is one tablet once a day until symptoms have stopped.
Estonian: Pantoloc Controli soovitatav annus on üks tablett üks kord päevas kuni sümptomite kadumiseni.
English: The most common side effects with Pantoloc Control (seen in around 1 patient in 100) are diarrhoea and headache.
Estonian: Pantoloc Controli kõige sagedamad kõrvaltoimed (esinenud enam kui 1 patsiendil 10-st) on kõhulahtisus ja peavalu.
English: Pantoloc Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients.
Estonian: Pantoloc Controli ei tohi kasutada patsiendid, kes on pantoprasooli, soja või selle ravimi mõne muu koostisaine suhtes ülitundlikud (allergilised).
English: The CHMP therefore decided that Pantoloc Control's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Pantoloc Controli kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: Pantoloc Control is used for the short-term treatment of the symptoms of acid reflux in adults.
Estonian: Pantoloc Controli kasutatakse refluksisümptomite lühiajaliseks raviks täiskasvanutel.
English: This is a summary of the European public assessment report (EPAR) for Pantoloc Control.
Estonian: See on ravimi Pantoloc Control Euroopa avaliku hindamisaruande kokkuvõte.
English: Pantoloc Control pantoprazole
Estonian: Pantoloc Control pantoprasool
English: For more information about treatment with Pantoloc Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Pantoloc Controliga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Pantoloc Control is a medicine that contains the active substance pantoprazole.
Estonian: Pantoloc Control on ravim, mis sisaldab toimeainena pantoprasooli.
English: Other information about Pantoloc Control
Estonian: Muu teave Pantoloc Controli kohta
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pantoloc Control.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: The active substance in Pantoloc Control, pantoprazole, is a proton pump inhibitor.
Estonian: Pantoloc Controli toimeaine pantoprasool on prootonpumba inhibiitor.
English: It is used for long-term treatments and is also used to treat a wider range of gastrointestinal diseases (conditions affecting the gut) than Pantoloc Control.
Estonian: Seda kasutatakse pikaajaliseks raviks ja võrreldes Pantoloc Controliga suurema hulga seedetrakti haiguste (soolehaiguste) raviks.
English: Pantoloc Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Pantoloc.
Estonian: Pantoloc Control on sarnane võrdlusravimiga Pantoloc, millel juba on Euroopa Liidus müügiluba.
English: For the full list of all side effects reported with Pantoloc Control, see the package leaflet.
Estonian: Pantoprasooli kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The reference medicine, Pantoloc, is only available with a prescription.
Estonian: Võrdlusravimit Pantoloci saab üksnes retsepti alusel.
English: Why has Pantoloc Control been approved?
Estonian: Miks Pantoloc Control heaks kiideti?
English: What is Pantoloc Control?
Estonian: Mis on Pantoloc Control?
English: What is the risk associated with Pantoloc Control?
Estonian: Mis riskid Pantoloc Controliga kaasnevad?
English: What benefit has Pantoloc Control shown during the studies?
Estonian: Milles seisneb uuringute põhjal Pantoloc Controli kasulikkus?
English: What is Pantoloc Control used for?
Estonian: Milleks Pantoloc Controli kasutatakse?
English: How is Pantoloc Control used?
Estonian: Kuidas Pantoloc Controli kasutatakse?
English: How does Pantoloc Control work?
Estonian: Kuidas Pantoloc Control toimib?
English: How has Pantoloc Control been studied?
Estonian: Kuidas Pantoloc Controli uuriti?
English: The reference Member State was France and 12 concerned Member States were involved: Austria, Belgium, Denmark, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Slovenia, Spain and United Kingdom.
Estonian: Viiteliikmesriik oli Prantsusmaa ja taotlusega tegeles 12 asjaomast liikmesriiki: Austria, Belgia, Hispaania, Iirimaa, Itaalia, Kreeka, Luksemburg, Portugal, Saksamaa, Sloveenia, Taani ja Ühendkuningriik.
English: The final opinion was converted into a Decision by the European Commission on 25 September 2013.
Estonian: Lõplik arvamus vormistati Euroopa Komisjoni otsusena 25. septembril 2013.
English: The type II variation procedure (FR/V/0201/002/II/006) started on 16 May 2012.
Estonian: II tüüpi muutmismenetlus (FR/V/0201/002/II/006) algas 16. mail 2012.
English: On Day 90, major issues raised by the CMS, Belgium, remained unsolved.
Estonian: 90. päeval olid CMS-i (Belgia) tõstatud peamised küsimused lahendamata.
English: The Committee appointed Dr B. Urbain as rapporteur and Dr M. Holzhauser-Alberti as co-rapporteur.
Estonian: Komitee määras hindajaks dr B. Urbaini ja kaashindajaks dr M. Holzhauser-Alberti.
English: Veterinary Medicines and Product Data Management
Estonian: Veterinaarravimite ja ravimiteabe haldus
English: During the variation procedure a potential serious risk to animal health was identified by Belgium and in particular that the efficacy against the lice species had been insufficiently substantiated.
Estonian: Muutmismenetluse käigus tuvastas Belgia võimaliku raske riski loomade tervisele eelkõige seetõttu, et täiliikidevastane efektiivsus oli ebapiisavalt põhjendatud.
English: Written explanations were provided by the marketing authorisation holder on 20 May 2013.
Estonian: Müügiloa hoidja esitas kirjalikud selgitused 20. mail 2013.
English: The referral procedure started on 10 April 2013.
Estonian: Esildismenetlus algas 10. aprillil 2013.
English: Day 60 of the CMD(v) procedure was on 14 March 2013, and since there was no agreement the procedure was referred to the CVMP.
Estonian: menetluse 60. päev oli 14. märts 2013 ja kuna kokkuleppele ei jõutud, anti menetlus edasi veterinaarravikomiteele.
English: The CVMP was requested to give its opinion on whether or not the data for the type II variation application support the new indication against lice infestations.
Estonian: Komiteel paluti esitada arvamus, kas II tüüpi muutmistaotluse andmed toetavad uut näidustust täinakkuste vastu.
English: The CVMP concluded that a satisfactory efficacy towards Linognatus vituli, Bovicola bovis and Solenopotes capillatus can be expected in the field.
Estonian: Veterinaarravikomitee jõudis järeldusele, et valdkonnas võib eeldada rahuldavat tõhusust Linognatus vituli, Bovicola bovis'e ja Solenopotes capillatus'e vastases ravis.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments of the relevant sections of the Summary of Product Characteristics, labelling and package leaflet in Annex III.
Estonian: Asjakohased raviminimetused on I lisas, teaduslikud järeldused on II lisas ja ravimi omaduste kokkuvõtte, pakendi märgistuse ja pakendi infolehe asjakohaste jaotiste muudatused on III lisas.