FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with Mektovi can last for as long as the patient is benefiting from it and does not have unacceptable side effects.
Estonian: Ravi Mektoviga tohib jätkata seni, kuni see on patsiendile kasulik ja tal ei ole tekkinud vastuvõetamatuid kõrvalnähte.
English: The most common side effects with Mektovi and encorafenib taken together at the highest recommended doses are tiredness, nausea (feeling sick), diarrhoea, vomiting, retinal detachment (an eye problem that leads to poor vision), abdominal pain, joint pain, muscle pain and high levels of an enzyme called creatine kinase, which may indicate muscle problems.
Estonian: Mektovi kõige sagedamad kõrvalnähud kasutamisel koos enkorafeniibiga suurimates soovitatavates annustes on väsimus, iiveldus, kõhulahtisus, oksendamine, võrkkestairre (silmaprobleem, mis põhjustab nägemishäireid), kõhuvalu, liigesevalu, lihasevalu ja kreatiinkinaasi (teatav ensüüm) suur sisaldus, mis võib viidata lihaseprobleemidele.
English: Mektovi is used in combination with another medicine, encorafenib (Braftovi), and is only for patients whose cancer cells have a specific mutation (change) in their genes called 'BRAF V600'.
Estonian: Mektovit kasutatakse koos teise ravimi, enkorafeniibiga (Braftovi) ning see on ette nähtud üksnes patsientidele, kelle vähirakkudes on teatud geenimutatsioon (muutus) - BRAF V600.
English: A study of 577 patients with melanoma with the BRAF V600 mutation that had spread or could not be removed surgically showed that Mektovi with encorafenib prolongs the length of time patients live without their disease getting worse.
Estonian: Uuringus, milles osales 577 patsienti, kellel oli metastaatiline või kirurgiliselt eemaldamatu BRAF V600 mutatsiooniga melanoom, tõendati, et Mektovi koos enkorafeniibiga pikendab patsientide progresseerumiseta elumust (kui kaua patsiendid elasid ilma haiguse süvenemiseta).
English: Mektovi is a medicine for treating melanoma (a skin cancer) that has spread or cannot be removed by surgery.
Estonian: Mektovi on ravim, mida kasutatakse melanoomi (teatud liiki nahavähk) raviks, kui vähk on metastaatiline või seda ei saa kirurgiliselt eemaldada.
English: Mektovi in combination with encorafenib can help prolong the time these patients live without their disease getting worse.
Estonian: Mektovi koos enkorafeniibiga võib aidata pikendada nende patsientide progresseerumiseta elumust.
English: The active substance in Mektovi, binimetinib, works by blocking MEK directly and by preventing its activation by BRAF thereby slowing down the growth and spread of the cancer.
Estonian: Mektovi toimeaine binimetiniib blokeerib vahetult MEK-valgu ja takistab BRAF-valgul seda aktiveerimast, aeglustades nii vähi kasvu ja levikut.
English: How is Mektovi used?
Estonian: Kuidas Mektovit kasutatakse?
English: Mektovi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in prescribing cancer medicines.
Estonian: Ravi peab alustama ja jälgima vähiravimite määramises kogenud arst.
English: What benefits of Mektovi have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Mektovi kasulikkus?
English: How does Mektovi work?
Estonian: Kuidas Mektovi toimib?
English: An overview of Mektovi and why it is authorised in the EU
Estonian: Ülevaade ravimist Mektovi ja ELis müügiloa väljastamise põhjendus
English: It contains the active substance binimetinib.
Estonian: Ravim sisaldab toimeainena binimetiniibi.
English: Why is Mektovi authorised in the EU?
Estonian: ELis Mektovile väljastatud müügiloa põhjendus
English: Vaccination scheme:
Estonian: Vaktsineerimisprogramm:
English: To the user:
Estonian: Kasutajale:
English: Under field conditions, sporadic local and systemic clinical reactions have been reported.
Estonian: Farmitingimustes on esinenud sporaadilisi lokaalseid ja süsteemseid kliinilisi reaktsioone.
English: If pain persists for more than 12 hours after medical examination, seek medical advice again.
Estonian: Juhul kui valu püsib rohkem kui 12 tundi pärast arstlikku kontrolli, pöördu uuesti arsti poole.
English: Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated.
Estonian: Seetõttu pole tõestatud vaktsiini ohutus ja efektiivsus tema kasutamisel koos teiste vaktsiinidega (nii kasutamisel samal päeval kui ka muul ajal).
English: 4.8 Interactions with other medicinal products and other forms of interaction
Estonian: 4.8 Koostoimed teiste ravimitega ja teised koostoimed
English: Do not mix with any other vaccine/immunological product.
Estonian: Mitte segada teiste vaktsiinide/immunoloogiliste preparaatidega.
English: Do not use in birds in lay (see section 4.3).
Estonian: Mitte kasutada munevatel kanadel (vt. punkt 4.3.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Estonian: MÄRGE ”AINULT VETERINAARSEKS KASUTAMISEKS” NING TINGIMUSED VÕI PIIRANGUD TARNIMISE JA KASUTAMISE OSAS, kui need on kohaldatavad
English: Excludes aromatic and unsaturated compounds
Estonian: Väljaarvatud aromaatsed ja küllastumata ühendid
English: No information is available on the compatibility of this vaccine with any other.
Estonian: Puuduvad andmed vaktsiini kokkusobivuse kohta teiste vaktsiinidega.
English: EXP: (Month/Year) ……/…..
Estonian: KÕLBLIKKUSAEG (Kuu/Aasta)...../.....:
English: 500 ml (2000 doses)
Estonian: 500 ml (2000 doosi)
English: Marketing authorisation holder and manufacturer:
Estonian: Müügiloa hoidja ja tootja:
English: Any person intending to import, sell, supply and/or use the product must consult the relevant Member States Competent Authority on the current vaccination policies prior to the import, sale, supply and/or use.
Estonian: Iga isik kes plaanib importida, turustada, tarnida, ja/või kasutada Nobilis OR inac süsteemulsiooni peab enne ravimi importi, turustamist, tarnimist ja/või kasutamist konsulteerima vastava liikmesriigi vastutava ametkonnaga vaktsineerimispoliitika osas.
English: Intervet International Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Estonian: Intervet International Wim de Körverstraat 35 5831 AN Boxmeer Holland
English: Mineral hydrocarbons, low to high viscosity including microcristalline waxes, approximately C10-C60; aliphatic, branched aliphatic and alicyclic compounds.
Estonian: Mineraalsed süsivesinikud, madala kuni kõrge viskoossusega kaasa arvatud mikrokristalliin vahad, ligikaudu C10-C60; alifaatsed, ahelalised alifaatsed ja ühendid.
English: a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
Estonian: a) veterinaarravimi manustamine loomadele segab veterinaarhaiguste diagnoosimise, kontrolli ja haigustõrje riiklike programmide rakendamist, või komplitseerib nakkuste puudumise tõendamist elusloomadel või toiduainetes või muudes toodetes, mis on saadud loomadelt, kellele on manustatud ravimit;
English: Occasionally hardened minor local swellings (0.5 - 2.0 cm) were observed which disappeared within 21 days after vaccination.
Estonian: Harvadel juhtudel võib tekkida piiratud lokaalne turse (0,5…2,0 cm), mis kaob 21 päeva jooksul.
English: Use sterile vaccination equipment.
Estonian: Kasutada steriilseid vahendeid.
English: For a list of excipients, see section 6.1
Estonian: Abiainete terviklik loetelu on esitatud punktis 6.1.
English: The import, sale, supply and/or use of the product is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Estonian: Import, turustamine, tarnimine ja /või kasutamine on või võivad kindlate liikmesriikide territooriumil või osal territooriumist olla keelatud vastavalt kohalikule, rahvuslikule loomatervishoiu poliitikale.
English: The first injection can be administered at an age of 6 - 12 weeks.
Estonian: Esmase vaktsineerimise võib teha vanuses 6…12 nädalat.
English: Light liquid paraffin: 107.21 mg
Estonian: Kerge vedel parafiin: 107,21 mg
English: Intervet International Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands
Estonian: Intervet International Wim de Körverstraat 35 NL-5831 AN Boxmeer Holland
English: All food producing species
Estonian: Kõigile toiduliikidele
English: Store and transport at 2 - 8°C.
Estonian: Hoida ja transportida temperatuuril 2...8°C.
English: • Sorbitan oleate (E 494), Potassium dihydrogen phosphate (E 340), Disodium hydrogen phosphate (E 339) and Potassium chloride (E 508) are approved as additives in foodstuffs for human consumption and therefore covered by Annex II of Council Regulation (EEC) No. 2377/90 for substances with an E- number1 (with the exception of preservatives listed in part C of Annex III
Estonian: Sorbitaan oleaat (E494), kaalium dihüdrogeen fosfaat (E340), dinaatrium hüdrogeen fosfaat (E339) ja kaalium kloriid (E508) on heaks kiidetud kui inimtoiduained ja seetõttu on nad kaetud nõukogu määruse lisaga II (EMÜ) nr 2377/90 E- numbriga1 ainetele (välja arvatud säilitusained, mis on loetletud lisa III C osas nõukogu direktiivis Directive 95/2/EC2.
English: * inducing a mean titre in the chickens of the potency test of at least 11.2 (log2).
Estonian: * indutseerib kanadel tugevustestis tiitri vähemalt 11,2 (log2).
English: The second injection has to be administered at least 6 weeks later at an age of 14 - 18 weeks.
Estonian: Teist korda manustatakse vaktsiini vähemalt 6 nädala möödumisel, vanuses 14…18 nädalat.
English: SPECIAL STORAGE CONDITIONS Store and transport at 2 - 8°C.
Estonian: SÄILITAMISE ERITINGIMUSED Hoida ja transportida temperatuuril 2...8°C .
English: In laboratory studies, a local transient swelling was found at post mortem examination in up to 40% of the birds for at least 14 days after subcutaneous vaccination.
Estonian: Laboratoorsetes uuringutes leiti lahangul kuni 40% vaktsineeritud lindudest 14 päeva jooksul pärast vaktsineerimist kerget mööduvat turset süstekohal.
English: THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN" Keep out of the reach and sight of children
Estonian: MÄRGE ”HOIDA LASTE EEST VARJATUD JA KÄTTESAAMATUS KOHAS” Hoida laste eest varjatud ja kättesaamatus kohas.
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Estonian: Avastades kõrvaltoimeid, mida ei ole mainitud, teavita sellest loomaarsti.
English: Do not use after the expiry date stated on the label.
Estonian: Pärast etiketil märgitud kõlblikkusaja lõppu mitte kasutada
English: Light liquid paraffin, Polysorbate 80, Sorbitan oleate, phosphate buffered aqueous solution 6.2 Incompatibilities
Estonian: Kerge vedel parafiin, polüsorbaat 80, sorbitaanoleaat, fosfaatpuhvriga vesilahus
English: Shelf life after first opening: Use immediately after opening
Estonian: Kõlblikkusaeg pärast esmast avamist: koheselt kasutada.
English: 1 PET vial with 250 ml (1000 doses) 1 PET vial with 500 ml (2000 doses)
Estonian: 1 PET viaal 250 ml (1000 doosi) 1 PET viaal 500 ml (2000 doosi)
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 250 ml (1000 doses)
Estonian: PAKENDI SISU KAALU, MAHU VÕI DOOSIDE JÄRGI 250 ml (1000 doosi)
English: ROUTES OF ADMINISTRATION s.c. injection or i.m.
Estonian: MANUSTAMISTEE(D) s.c. või i.m.
English: Shake well before use.
Estonian: Enne tarvitamist loksutada.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" For animal treatment only.
Estonian: LAUSE ”AINULT VETERINAARSEKS KASUTAMISEKS” Ainult veterinaarseks kasutamiseks.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 0.25 ml:
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS 1 doos 0,25 ml sisaldab:
English: MANUFACTURER'S BATCH NUMBER Batch: ……
Estonian: TOOTJAPOOLNE PARTII NUMBER PARTII:
English: (EEC) No 2377/90 does not apply.
Estonian: Immuunsuse tekitamiseks bioloogilise päritoluga toimeainetele nõukogu määrust (EMÜ) nr 2377/90 ei kohaldata
English: The vaccination scheme consists of two injections with a dose of 0.25 ml, administered subcutaneously in the neck or intramuscularly in the breast.
Estonian: Vaktsineerimisskeem koosneb kahest manustamisest doosis 0,25 ml nahaalusi kaela või lihastesisesi rinnalihasesse.
English: • The adjuvants and excipients listed are included in Annex II of Council Regulation (EEC) No
Estonian: Nimekirjas olevad adjuvandid ja abiained on esitatud nõukogu määruse (EMÜ) nr 2377/90 lisas II.
English: For animal treatment only -to be supplied only on veterinary prescription.
Estonian: Ainult veterinaarseks kasutamiseks─ tarnida üksnes veterinaararsti retsepti olemasolul.
English: Accidental self-injection is dangerous - see package insert
Estonian: Juhuslik veterinaarpreparaadi enesele süstimine võib olla ohtlik - loe pakendi infolehte.
English: Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with the local requirements.
Estonian: Kasutamata veterinaarpreparaat või jäätmematerjal tuleb hävitada vastavalt kohalikulele seadusandlusele.
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
Estonian: MÜÜGILOA TINGIMUSED VÕI PIIRANGUD OHUTU JA EFEKTIIVSE KASUTAMISE OSAS
English: injection of one dose of 0.25 ml.
Estonian: üks doos doosis 0,25 ml
English: Do not use in birds in lay.
Estonian: Mitte kasutada munevatel kanadel.
English: If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you.
Estonian: Kui oled juhuslikult endale ravimit süstinud, võtta kaasa pakendi infoleht ja pöörduda kiiresti arsti poole, isegi kui süstitud kogus oli väga väike.
English: SPECIAL WARNING(S), IF NECESSARY Oil adjuvanted vaccine
Estonian: ERIHOIATUS(ED) KUI VAJALIK
English: Active substance
Estonian: TOIMEAINE
English: NAME OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT
Estonian: MÜÜGILOA HOIDJA NIMI JA AADRESS JA PARTII VABASTAMISE EEST VASTUTAV MÜÜGILOAHOIDJA EMP-s, JUHUL KUI SEE ON ERINEV
English: Per dose of 0.25 ml:
Estonian: 1 doos 0,25 ml sisaldab:
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Single dose of 0.25 ml.
Estonian: ANNUSTAMINE LOOMALIIGITI, MANUSTAMISTEE(D) JA -MEETOD Ühekordne doos 0,25 ml.
English: ACTIVE SUBSTANCE(S) Inactivated whole cell suspension of O. rhinotracheale Light liquid paraffin
Estonian: Inaktiveeritud O. rhinotracheale rakususpensioon Kerge vedel parafiin
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous injection in the neck or intramuscular injection in the breast of one dose of 0.25 ml.
Estonian: MANUSTAMISVIIS JA -TEE(D) Nahaalusi kaela või lihastesisesi rinnalihasesse doosis 0,25 ml linnu kohta.
English: For animal treatment only.
Estonian: Ainult veterinaarseks kasutamiseks
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Estonian: BIOLOOGILIS(T)E TOIMEAINE(TE) TOOTJA(d) JA TOOTMISLOA HOIDJA, KES VASTUTAB RAVIMIPARTII VABASTAMISE EEST
English: CONTRAINDICATIONS Do not use for birds in lay
Estonian: VASTUNÄIDUSTUSED Mitte kasutada munevatel kanadel.
English: Allow vaccine to reach room temperature (15-25°C) before using the vaccine.
Estonian: Enne manustamist soojendada vaktsiini toatemperatuurini 15...25°C.
English: WITHDRAWAL PERIOD Zero days
Estonian: KEELUAJAD 0 päeva
English: 4.11 Withdrawal period
Estonian: 4.11 Keeluajad
English: Inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A strain B3263/91 1 x 107 cells *
Estonian: Inaktiveeritud Ornithobacterium rhinotracheale serotüüppe A bakterirakkude suspensiooni, tüvi B3263/91,1 x 107 *rakku.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis OR inac emulsion for injection for chickens
Estonian: VETERINAARRAVIMI NIMETUS Nobilis OR inac süsteemulsioon kanadele
English: Subcutaneous injection in the neck or intramuscular injection in the breast of the chicken.
Estonian: Nahaalusi kaela piirkonda või lihastesisesi rinnalihasesse.
English: The product contains the inactivated whole cells of Ornithobacterium rhinotracheale serotype A, strain B3263/91 mixed with an oil adjuvant.
Estonian: Preparaat sisaldab terveid inaktiveeritud Ornithobacterium rinotracheale serotüüp A tüve B2363/91 rakke seotuna õliadjuvandiga.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/02/036/001-002
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/02/036/001-002
English: B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Estonian: MÜÜGILOA TINGIMUSED VÕI PIIRANGUD TARNIMISE VÕI KASUTAMISE OSAS
English: Traces of formaldehyde
Estonian: Formaldehüüdi jäägid
English: MARKETING AUTHORISATION NUMBER(S) EU/2/02/036/001 (250 ml)
Estonian: MÜÜGILOA NUMBER(NUMBRID) EU/2/02/036/001 (250 ml)
English: No other undesirable effects have been observed after administration of a double dose when compared with a single dose of vaccine.
Estonian: Kahekordsel üledoseerimisel ei ole täheldatud kõrvaltoimeid.
English: Once broached: Use immediately
Estonian: Peale avamist kasutada koheselt.
English: Name and address of the manufacturer of the biological active substance
Estonian: Bioloogilis(t)e toimeaine(te) tootja nimi ja aadress
English: Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Estonian: Juhuslik enesele süstimine võib põhjustada tugevat valu ja turset, eriti kui on süstitud liigesepiirkonda või sõrme.
English: Under field conditions passive immunity is transferred during lay for 43 weeks after the last vaccination of broiler breeders, resulting in a duration of passive immunity in broilers of at least 14 days after hatching.
Estonian: Farmitingimustes annavad emalinnud passiivse immunsuse edasi 43 nädala jooksul pärast vaktsineerimist.
English: Nobilis OR inac emulsion for injection for chickens
Estonian: PAKENDI INFOLEHT Nobilis OR inac süsteemulsioon kanadele
English: EU Number EU/2/02/036/001 (250 ml) EU/2/02/036/002 (500 ml)
Estonian: MÜÜGILOA NUMBER (NUMBRID EU/2/02/036/001 (250 ml) EU/2/02/036/002 (500 ml)
English: 4.2 Indications for use, specifying the target species For passive immunisation of broilers induced by active immunisation of female broiler breeders to reduce infection with Ornithobacterium rhinotracheale serotype A when this agent is involved.
Estonian: 4.2 Näidustused, määrates kindlaks vastavad loomaliigid Broilerite passiivseks immuniseerimiseks emalindude aktiivse immuniseerimise kaudu broilerite Ornithobacterium rhinotracheale serotüüp A vastu.
English: Name and address of the manufacturer responsible for batch release
Estonian: Ravimipartii väljastamise eest vastutava tootja nimi ja aadress:
English: Adjuvant
Estonian: Arstile:
English: Keep out of the reach and sight of children.
Estonian: Hoida lastele kättesaamatus kohas.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Estonian: MINIMAALSED NÕUDED; MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Estonian: TOIMEAINE(TE) JA ABIAINETE SISALDUS
English: For passive immunisation of broilers induced by active immunisation of female broiler breeders to reduce infection with Ornithobacterium rhinotracheale serotype A when this agent is involved.
Estonian: Broilerite passiivseks immuniseerimiseks emalindude aktiivse immuniseerimise kaudu Ornithobacterium rhinotracheale serotüüp A vastu.
English: PACKAGE LEAFLET
Estonian: Abiainete loetelu
English: Pharmacotherapeutic group: Inactivated bacterial vaccine ATCvet code: QI 01AB07
Estonian: Farmakoterapeutiline grupp: inaktiveeritud baktervaktsiin, ATC-vet kood: QI 01AB07 Vaktsiin stimuleerib sugubroileritel aktiivset immuunsust ja tugevdab järglaste passiivset immuunsust Ornithobacterium rhinotracheale serotüüp A vastu.
English: The vaccine is to stimulate active immunity in broiler breeders in order to provide passive immunity to the progeny against Ornithobacterium rhinotracheale serotype A .
Estonian: Vaktsiin stimuleerib emalindude aktiivse immuniseerimise kaudu broilerite passiivset immuunsust Ornithobacterium rhinotracheale serotüüp A vastu.
English: 6.5 Nature and composition of immediate packaging Carton box with one Polyethylene Terephthalate (PET) vial of 250 ml (1000 doses) or 500 ml (2000 doses), closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap. 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Estonian: Kartongkarp, milles on üks polüetüleentereftalaat (PET) pudel 250 ml (1000 doosi) või 500 ml (2000 doosi).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA
Estonian: MÜÜGILOA HOIDJA NING, KUI NEED EI KATTU, RAVIMIPARTII VÄLJASTAMISE EEST VASTUTAVA TOOTMISLOA HOIDJA NIMI JA AADRESS
English: To the physician:
Estonian: Adjuvant(adjuvandid):
English: Pack size blister (PVC/PE/PVDC/alu)
Estonian: Pakendi suurus blister (PVC/PE/PVDC/alu)
English: 30 mg Film-coated tablet Oral use
Estonian: 30 mg Õhukese polümeerikatt ega tablet
English: Immediate Packaging
Estonian: 1 tablett
English: Further information on Invirase can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave Invirase kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Invirase?
Estonian: Mis meetmed võetakse, et tagada Invirase ohutu ja efektiivne kasutamine?
English: What is Invirase and what is it used for?
Estonian: Mis on Invirase ja milleks seda kasutatakse?
English: Invirase received a marketing authorisation valid throughout the EU on 4 October 1996.
Estonian: Invirase on saanud müügiloa, mis kehtib kogu ELis, 4. oktoobril 1996.
English: The European Medicines Agency decided that Invirase's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Invirase kasulikkus on suurem kui sellega kaasnevad riskid, ja lubati ravimi kasutamine ELis.
English: Invirase was found effective in the treatment of HIV infection in six main studies involving a total of 1,576 patients.
Estonian: Invirase efektiivsust HIV-nakkuse ravis tõendati kuues põhiuuringus, milles osales kokku 1576 patsienti.
English: These studies measured the viral load after 48 weeks.
Estonian: Nendes uuringutes määrati patsientide viiruskoormus 48 nädala järel.
English: This allows effective treatment while avoiding a higher dose of saquinavir.
Estonian: See võimaldab efektiivset ravi, vältides samal ajal sakvinaviiri suuremat annust.
English: Invirase is available as capsules (200 mg) and tablets (500 mg).
Estonian: Inviraset turustatakse kapslitena (200 mg) ja tablettidena (500 mg).
English: Invirase (saquinavir)
Estonian: Invirase (sakvinaviir)
English: As for all medicines, data on the use of Invirase are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Invirase kasutamise kohta pidevat järelevalvet.
English: Side effects reported with Invirase are carefully evaluated and any necessary action taken to protect patients.
Estonian: Invirase kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Two further studies involving 656 patients compared Invirase with indinavir or lopinavir (other HIV medicines).
Estonian: Kahes muus uuringus (656 patsienti) võrreldi Inviraset indinaviiri või lopinaviiriga (samuti HIV-ravimid).