FrancophonIA/ELRC3.0 huggingface dataset:
English: Some patients are expected to benefit from an increase in dose from 1.2 mg to 1.8 mg and based on clinical response, after at least one week, the dose can be increased to 1.8 mg to further improve glycaemic control.
Estonian: Vastavalt kliinilisele vastusele ning mitte varem kui ühe nädala möödudes võib vere glükoosi taseme regulatsiooni edasiseks parandamiseks suurendada annust 1,8 mg-ni.
English: General disorders and administration site conditions
Estonian: Üldised häired ja manustamiskoha reaktsioonid
English: Mean HbA1c change from baseline (%)
Estonian: HbA1c muutus algväärtusest
English: 1 ml of solution contains 6 mg of liraglutide*.
Estonian: 1 ml lahust sisaldab 6 mg liraglutiidi*.
English: Do not store the pen with a needle attached.
Estonian: Hoidke pensüstel ilma nõelata.
English: Monotherapy
Estonian: Monoteraapia
English: Self-monitoring of blood glucose is not needed in order to adjust the dose of Victoza.
Estonian: Victoza annuse kohandamiseks pole patsiendil endal vaja glükoosi taset jälgida.
English: Common: may affect up to 1 in 10 people
Estonian: Sage: võivad avalduda kuni ühel inimesel 10-st.
English: 1all patients; 2previous OAD monotherapy; 3previous diet treated patients 5Victoza add-on to SGLT2i was investigated at all approved doses of SGLT2i 4the dosing of insulin glargine was open-labelled and was applied according to Guideline for titration of insulin glargine.
Estonian: 5Victoza lisatuna SGLT2i uuriti kõigi kinnitatud SGLT2i annuste korral
English: Paracetamol
Estonian: Paratsetamool
English: The incidence of withdrawal due to adverse reactions was 7.8% for liraglutide-treated patients and 3.4% for comparator-treated patients in the long-term controlled trials (26 weeks or longer).
Estonian: Pikaajalistes kontrollitud uuringutes (26 nädalat või kauem) oli kõrvaltoimetest põhjustatud katkestamise juhte 7,8% liraglutiidravi saanud patsientide osas ja 3,4% võrdlusravimit saanute osas.
English: Reporting of side effects
Estonian: Kõrvaltoimetest teatamine
English: PHARMACEUTICAL FORM
Estonian: Retseptiravim
English: Liraglutide did not change the overall exposure of griseofulvin following administration of a single dose of griseofulvin 500 mg. Griseofulvin Cmax increased by 37% while median tmax did not change.
Estonian: Griseofulviini Cmax suurenes 37%, samas kui mediaanne tmax ei muutunud.
English: • Postprandial glucose
Estonian: • Söögijärgne glükoos
English: Intestinal obstruction
Estonian: Südame häired
English: Vomiting Dyspepsia Abdominal pain upper
Estonian: Oksendamine Seedehäire Valud ülakõhus Kõhukinnisus Gastriit
English: Liraglutide 1.8 mg 234 8.5
Estonian: Liraglutiid 1,8 mg 234 8,5
English: Liraglutide 1.2 mg 228 8.5
Estonian: Liraglutiid 1,2 mg 228 8,5
English: Few cases of acute pancreatitis (<0.2%) have been reported during long-term, controlled phase 3 clinical trials with Victoza.
Estonian: Victoza pikaajaliste, III faasi kontrollitud kliiniliste uuringute käigus esines üksikuid ägeda pankreatiidi juhte (<0,2%).
English: Ethnic origin had no clinically relevant effect on the pharmacokinetics of liraglutide based on the results of population pharmacokinetic analysis which included patients of White, Black, Asian and Hispanic groups.
Estonian: Valge- ja mustanahaliste patsientide, asiaatide ja hispaaniakeelsetest kogukondadest pärit patsientide populatsiooni farmakokineetilise analüüsi tulemuste põhjal ei omanud etniline päritolu kliiniliselt olulist mõju liraglutiidi farmakokineetikale.
English: Liraglutide 1.8 mg 242 8.4
Estonian: Liraglutiid 1,8 mg 242 8,4
English: Few cases of cholelithiasis (0.4%) and cholecystitis (0.1%) have been reported during long-term, controlled phase 3a clinical trials with liraglutide.
Estonian: Liraglutiidi pikaajalistes, IIIa faasi kontrollitud kliinistes uuringutes on üksikjuhtudel teatatud sapikividest (0,4%) ja sapipõiepõletikust (0,1%).
English: The contraceptive effect is therefore anticipated to be unaffected when co-administered with liraglutide.
Estonian: Seetõttu eeldatakse, et manustamine koos liraglutiidiga ei kahjusta rasestumisvastaste ravimite toimet.
English: In five large long-term clinical phase 3a trials over 2,500 adult patients have received treatment with Victoza alone or in combination with metformin, a sulfonylurea (with or without metformin) or metformin plus rosiglitazone.
Estonian: Victoza-ravi või Victoza-ravi kombineerituna metformiini, sulfonüüluurea (koos metformiiniga või ilma) või metformiini ja rosiglitasooniga.
English: • Fasting plasma glucose
Estonian: • Vere glükoosisisalduse kontroll
English: • A delay in the emptying of the stomach.
Estonian: • Ebamugavustunne kõhus
English: Disodium phosphate dihydrate Propylene glycol Phenol
Estonian: Dinaatriumfosfaatdihüdraat Propüleenglükool Fenool
English: Liraglutide 1.2 mg 240 8.3
Estonian: Liraglutiid 1,2 mg 240 8,3
English: Your pen comes with 18 mg of liraglutide.
Estonian: Teie pensüstel sisaldab 18 mg liraglutiidi.
English: Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeat-dose toxicity or genotoxicity.
Estonian: Farmakoloogilise ohutuse, kroonilise toksilisuse ja genotoksilisuse mittekliinilised uuringud ei ole näidanud kahjulikku toimet inimesele.
English: One pre-filled pen contains 18 mg liraglutide.
Estonian: Üks pensüstel sisaldab 18 mg liraglutiidi.
English: No pharmacokinetic or pharmacodynamic interactions were observed between liraglutide and insulin detemir when administering a single dose of insulin detemir 0.5 U/kg with liraglutide 1.8 mg at steady state in patients with type 2 diabetes.
Estonian: Manustades stabiilses seisundis 2. tüüpi diabeediga patsientidele ühekordse annusena 0,5 Ü/kg detemirinsuliini koos 1,8 mg liraglutiidiga ei täheldatud liraglutiidi ja detemirinsuliini vahelist farmakokineetilist ega farmakodünaamilist koostoimet.
English: Thyroid disease
Estonian: Kilpnäärmehaigused
English: Do not try to select other doses than 0.6 mg, 1.2 mg or 1.8 mg.
Estonian: Ärge püüdke valida teisi annuseid kui 0,6 mg, 1,2 mg või 1,8 mg. Näidikul olevad numbrid peavad õige annuse tagamiseks olema osutiga täpselt ühel joonel.
English: Pull off the pen cap.
Estonian: Eemaldage otsik.
English: • Toothache
Estonian: • Hambavalu
English: What is in this leaflet
Estonian: Üks pensüstel sisaldab
English: In addition, liraglutide had a beneficial effect on plasma lipids.
Estonian: Liraglutiid seondub ulatuslikult plasmavalkudega
English: Non-fatal myocardial infarction Expanded MACE
Estonian: Kardiovaskulaarne surm Surmaga mittelõppenud insult Surmaga mittelõppenud südamelihase infarkt Laialdasem MACE
English: (CrCL 30-59 ml/min, see section 5.1) had 26% lower liraglutide exposure when compared with a separate trial including patients with type 2 diabetes with normal renal function or mild renal impairment.
Estonian: Sarnaselt eelnevaga oli 26-nädalases kliinilises uuringus, milles osalesid 2. tüüpi diabeedi ja mõõduka neerupuudulikkusega (CrCl 30…59 ml/min, vt lõik 5.1) patsiendid, liraglutiidi ekspositsioon 26% väiksem kui 2. tüüpi diabeedi ja normaalse või kerge neerupuudulikkusega patsientidel.
English: Store away from the freezer compartment.
Estonian: Hoida sügavkülmkambrist eemal.
English: Urticaria Pruritus
Estonian: Peensoole sulgus
English: In a double-blind trial comparing the efficacy and safety of liraglutide 1.8 mg versus placebo as addon to insulin and/or OAD in patients with type 2 diabetes and moderate renal impairment, liraglutide was superior to placebo treatment in reducing HbA1c after 26 weeks (-1.05% vs -0.38%).
Estonian: Ühes topeltpimedas kontrollitud uuringus uuriti insuliinile ja /või suukaudsetele diabeediravimitele lisatud 1,8 mg liraglutiidi efektiivsust ja ohutust võrreldes platseeboga 2. tüüpi diabeediga ja mõõduka neerupuudulikkusega patsientidel.
English: No dose adjustment is required for patients with mild, moderate or severe renal impairment.
Estonian: Kerge, mõõduka või raske neerukahjustuse korral ei ole annuse kohandamine vajalik.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
English: Rosiglitazone 4 mg/day
Estonian: 4 mg/ööpäev
English: Atorvastatin
Estonian: Atorvastatiin
English: In an open label trial comparing the efficacy and safety of liraglutide 1.8 mg with lixisenatide 20 mcg in 404 patients inadequately controlled on metformin therapy (mean HbA1c 8.4%), liraglutide was superior to lixisenatide in reducing HbA1c after 26 weeks of treatment (-1.83% vs -1.21%, p<0.0001).
Estonian: Ühes avatud uuringus võrreldi 1,8 mg liraglutiidi ja 20 µg liksisenatiidi efektiivsust ja ohutust 404-l patsiendil, kelle vere glükoosisisalduse kontroll metformiiniga ei olnud piisav (keskmine HbA1c 8,4%).
English: Victoza 6 mg/ml solution for injection in pre-filled pen Liraglutide
Estonian: Victoza 6 mg/ml süstelahus pensüstlis Liraglutidum
English: 1 ml solution for injection contains 6 mg liraglutide.
Estonian: 1 ml süstelahust sisaldab 6 mg liraglutiidi.
English: Few cases of anaphylactic reactions with additional symptoms such as hypotension, palpitations, dyspnoea and oedema have been reported with marketed use of Victoza.
Estonian: Victoza turuloleku ajal on teatatud mõnest koos lisanähtudega esinenud anafülaktilisest reaktsioonist, nagu hüpotensioon, südamepekslemine, düspnoe ja ödeem.
English: Liraglutide 1.2 mg 251 8.18
Estonian: Liraglutiid 1,2 mg 251 8,18 -0,84*
English: • Wind (flatulence)
Estonian: Liraglutiid (Liraglutidum)
English: Hypoglycaemia
Estonian: Hüpoglükeemia
English: • Indigestion
Estonian: • Kõhukinnisus
English: • Dizziness
Estonian: • Kehakaal
English: Withdrawal
Estonian: Annustamine
English: Digoxin median tmax was delayed from 1 h to 1.5 h. No adjustment of digoxin dose is required based on these results.
Estonian: Digoksiini annuse kohandamine pole nende tulemuste põhjal vajalik.
English: No dose adjustment is recommended for patients with mild or moderate hepatic impairment.
Estonian: Annuse kohandamine ei ole soovitatav kerge ja mõõduka maksakahjustuse korral.
English: Excipients
Estonian: Imendumine
English: Uncommon: may affect up to 1 in 100 people
Estonian: Aeg-ajalt: võivad avalduda kuni ühel inimesel 100-st.
English: In an open label trial comparing the efficacy and safety of liraglutide 1.8 mg once daily and exenatide 10 mcg twice daily in patients inadequately controlled on metformin and/or sulfonylurea therapy (mean HbA1c 8.3%), liraglutide was statistically superior to exenatide treatment in reducing HbA1c after 26 weeks (-1.12% vs -0.79%; estimated treatment difference: -0.33; 95% CI: -0.47 to -0.18).
Estonian: Pärast 26 nädalat saavutati liraglutiidiga HbA1c vähendamises paremad tulemused kui eksenatiidraviga (-1,12% versus -0,79%; hinnanguline ravierinevus: -0,33; 95% CI: -0,47 kuni -0,18).
English: • Gallstones
Estonian: • Sapikivid
English: In an open label trial comparing the efficacy and safety of liraglutide (1.2 mg and 1.8 mg) and sitagliptin (a DPP-4 inhibitor, 100 mg) in patients inadequately controlled on metformin therapy (mean HbA1c 8.5%), liraglutide at both doses was statistically superior to sitagliptin treatment in reducing HbA1c after 26 weeks (-1.24%, -1.50% vs -0.90%, p<0.0001).
Estonian: Ühes avatud uuringus manustati patsientidele, kelle vere glükoosisisalduse kontroll metformiiniga ei olnud piisav (keskmine HbA1c 8,5%), liraglutiidi (1,2 mg ja 1,8 mg) või sitagliptiini (DPP-4 inhibiitor, 100 mg) ning võrreldi nende efektiivsust ja ohutust.
English: Pregnancy
Estonian: Süstevesi
English: Common • Vomiting.
Estonian: Sageli: • Oksendamine
English: Batch
Estonian: Sugu
English: Paediatric population
Estonian: Pensüstli hooldamine
English: Delayed gastric emptying
Estonian: Aeglustunud mao tühjenemine
English: Allergic reactions including urticaria, rash and pruritus have been reported from marketed use of Victoza.
Estonian: Victoza turuloleku ajal on teatatud allergilistest reaktsioonidest, sh nõgestõbi, punetus, kihelemine.
English: Victoza 6 mg/ml solution for injection in pre-filled pen
Estonian: Victoza 6 mg/ml süstelahus pensüstlis
English: In a double-blind study comparing the efficacy and safety of Victoza 1.8 mg versus placebo as add-on to metformin ± insulin in adolescents and children aged 10 years and above with type 2 diabetes, Victoza was superior to placebo treatment in reducing HbA1c after 26 weeks (-1.06, [-1.65, 0.46]).
Estonian: 2. tüüpi diabeediga noorukitel ja 10-aastastel ning vanematel lastel viidi läbi topeltpime Victoza 1,8 mg versus platseebo lisatuna metformiinile ± insuliinile efektiivsuse ja ohutuse uuring.
English: This summary was last updated in 03-2012.
Estonian: Kokkuvõtte viimane uuendus: 03-2012.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine Accord on 20 April 2012.
Estonian: Euroopa Komisjon andis Capecitabine Accordi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 20. aprillil 2012.
English: Treatment is continued for six months after colon surgery.
Estonian: Ravi jätkatakse 6 kuud pärast käärsoole operatsiooni.
English: The full EPAR for Capecitabine Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Capecitabine Accordi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Capecitabine Accord tablets should be swallowed with water within the 30 minutes after a meal.
Estonian: Capecitabine Accordi tabletid neelatakse veega 30 minuti jooksul pärast sööki.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but available at a new strength in addition to existing strengths.
Estonian: See on sarnane võrdlusravimiga, sisaldades sama toimeainet, kuid ravimit turustatakse lisaks olemasolevatele uues tugevuses.
English: Capecitabine Accord is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient's height and weight).
Estonian: Capecitabine Accordi võetakse kaks korda ööpäevas annustes 625-1250 mg kehapinna ühe ruutmeetri kohta (arvutatakse patsiendi pikkuse ja kaalu põhjal).
English: The doctor will calculate the number of 150, 300 and 500 mg tablets the patient needs to take.
Estonian: Arst arvutab välja 150, 300 ja 500 mg tablettide arvu, mille patsient peab manustama.
English: As a result, it inhibits the growth of tumour cells and eventually kills them.
Estonian: Selle tulemusel inhibeerib 5-FU kasvajarakkude kasvu ja lõpuks hävitab need.
English: The company provided data from studies to determine that it is bioequivalent to the reference medicine, Xeloda.
Estonian: Ettevõte edastas uuringute andmed, et tõendada ravimi bioekvivalentsust võrdlusravimiga Xeloda.
English: Therefore, the CHMP's view was that, as for Xeloda, the benefit outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu ka Xeloda korral, ületab ravimi kasulikkus sellega kaasnevad riskid.
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 Capecitabine Accord.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: It is used to treat:
Estonian: Ravinäidustused on:
English: For more information about treatment with Capecitabine Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Capecitabine Accordiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: While the reference medicine, Xeloda, is available as 150 and 500 mg tables, Capecitabine Accord is also available as 300 mg tablets.
Estonian: Võrdlusravimit Xeloda turustatakse 150 ja 500 mg tablettidena, ravimit Capecitabine Accord aga ka 300 mg tablettidena.
English: Because Capecitabine Accord is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Capecitabine Accord on võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: Full details are available in the summary of product characteristics (also part of the EPAR).
Estonian: Üksikasjalik teave on esitatud ravimi omaduste kokkuvõttes (samuti Euroopa avaliku hindamisaruande osa).
English: • locally advanced or metastatic breast cancer (breast cancer that has begun to spread to other parts of the body).
Estonian: • paikne kaugelearenenud või metastaatiline rinnanäärmevähk (rinnavähk, mis on hakanud levima organismis ka mujale).
English: The CHMP concluded that, in accordance with EU requirements, Capecitabine Accord has been shown to have comparable quality and to be bioequivalent to Xeloda.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Capecitabine Accord võrdväärne kvaliteet ja bioekvivalentsus ravimiga Xeloda.
English: It can also be used on its own when treatment with both anthracyclines and taxanes (another type of anticancer medicine) has failed or when repeat treatment with anthracyclines is not suitable for the patient.
Estonian: Seda ravimit võib kasutada ka ainsa ravimina, kui ravi antratsükliinide ja taksaanidega (teist liiki vähiravimid) ei ole andnud tulemust või kui kordusravi antratsükliinidega patsiendile ei sobi.
English: Capecitabine Accord is used with or without other anticancer medicines;
Estonian: Capecitabine Accordi kasutatakse koos teiste vähiravimitega või ilma nendeta;
English: The Committee recommended that Capecitabine Accord be given marketing authorisation.
Estonian: Komitee soovitas anda ravimi müügiloa.
English: EPAR summary for the public capecitabine
Estonian: Kokkuvõte üldsusele kapetsitabiin
English: • metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body).
Estonian: • metastaatiline kolorektaalvähk (jämesoolevähk, mis on levinud organismis ka mujale).
English: This is a summary of the European public assessment report (EPAR) for Capecitabine Accord.
Estonian: See on ravimi Capecitabine Accord Euroopa avaliku hindamisaruande kokkuvõte.
English: Capecitabine Accord is used with or without other anticancer medicines in patients who have had surgery for ‘stage III' or ‘Dukes' stage C' colon cancer;
Estonian: Capecitabine Accordi kasutatakse koos teiste vähiravimitega või ilma nendeta, et ravida käärsoolevähki patsientidel, kellele on tehtud III staadiumi ehk Dukes'i Cstaadiumi käärsoolevähi operatsioon;
English: Capecitabine Accord is a ‘hybrid generic medicine'.
Estonian: Capecitabine Accord on geneeriline hübriidravim.
English: Capecitabine Accord is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed.
Estonian: Capecitabine Accordi kasutatakse koos dotsetakseeliga (teine vähiravim), pärast tulemusteta ravi antratsükliinidega (teist tüüpi vähiravimid).
English: Doses need to be adjusted for patients with liver or kidney disease and for patients who develop certain side effects.
Estonian: Maksa- või neeruhaigusega patsientidel ja teatud kõrvalnähtude tekkimisel tuleb annuseid kohandada.
English: Capecitabine Accord is a medicine that contains the active substance capecitabine.
Estonian: Capecitabine Accord on ravim, mis sisaldab toimeainena kapetsitabiini.
English: Capecitabine Accord is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;
Estonian: Capecitabine Accordi kasutatakse koos teiste vähiravimitega, sealhulgas plaatinat sisaldava vähiravimiga (näiteks tsisplatiiniga);
English: Capecitabine Accord should only be prescribed by a doctor who is qualified in the use of anticancer medicines.
Estonian: Capecitabine Accordi tohib määrata üksnes vähiravimite pädevusega arst.
English: The active substance in Capecitabine Accord, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Estonian: Capecitabine Accordi toimeaine kapetsitabiin on antimetaboliitide (raku normaalset ainevahetust pärssiv aine) hulka kuuluv tsütotoksiline ravim (ravim, mis hävitab poolduvaid rakke, näiteks kasvajarakke).
English: Other information about Capecitabine Accord
Estonian: Muu teave Capecitabine Accordi kohta
English: Why has Capecitabine Accord been approved?
Estonian: Miks Capecitabine Accord heaks kiideti?
English: What are the benefits and risks of Capecitabine Accord?
Estonian: Milles seisneb Capecitabine Accordi kasulikkus ja mis riskid ravimiga kaasnevad?
English: What is Capecitabine Accord?
Estonian: Mis on Capecitabine Accord?
English: • advanced gastric (stomach) cancer.
Estonian: • kaugelearenenud maovähk.
English: Capecitabine Accord is an anticancer medicine.
Estonian: Capecitabine Accord on vähiravim.
English: How has Capecitabine Accord been studied?
Estonian: Kuidas Capecitabine Accordi uuriti?
English: How is Capecitabine Accord used?
Estonian: Kuidas Capecitabine Accordi kasutatakse?
English: What is Capecitabine Accord used for?
Estonian: Milleks Capecitabine Accordi kasutatakse?
English: How does Capecitabine Accord work?
Estonian: Kuidas Capecitabine Accord toimib?
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES
Estonian: LISA I RAVIMITE NIMETUSTE, RAVIMVORMIDE, TUGEVUSTE, MANUSTAMISVIISIDE, TAOTLEJATE, MÜÜGILOA HOIDJATE LOETELU LIIKMESRIIKIDES
English: United Kingdom
Estonian: UKÜhendkuningriik
English: Portugal
Estonian: PT - Portugal
English: Netherlands
Estonian: NL - Holland
English: Norway
Estonian: NO - Norra
English: Cyprus
Estonian: CY - Küpros
English: Czech Republic
Estonian: CZ - Tšehhi Vabariik
English: Romania
Estonian: RO - Rumeenia
English: Poland
Estonian: PL - Poola
English: Belgium
Estonian: BE - Belgia
English: Sweden
Estonian: SE - Rootsi
English: Luxembourg
Estonian: LU - Luksemburg
English: Iceland
Estonian: IS - Island
English: Austria
Estonian: AT - Austria
English: Ireland
Estonian: IE - Iirimaa
English: Slovak Republic
Estonian: SK - Slovakkia
English: Italy
Estonian: IT - Itaalia
English: France
Estonian: FR - Prantsusmaa
English: Bulgaria
Estonian: BG - Bulgaaria
English: Germany
Estonian: DE - Saksamaa
English: Mikrogramm/10 Mikrogramm pro Sprühstoß Druckgasinhalation
Estonian: Mikrogramm/5 Mikrogramm pro Sprühstoß
English: Flutiform® 250/10 µg 250mcg/10mcg
Estonian: Flutiform® 250/10 µg
English: 140 (2 x 70) tablets (multipack)
Estonian: Suukaudne Blister (PA/Alu/PVC/Alu) 140 (2x70) tabletti (multipakend)
English: MA (EU) number (Invented) name
Estonian: Müügiloa nr Euroopa Liidus (Väljamõeldud) nimetus
English: Pack size
Estonian: Pakendi suurus
English: Pharmaceutical Form
Estonian: Tugevus Ravimvorm Manustamistee Sisepakendi iseloomustus
English: In very rare cases, a decrease in water intake has been observed.
Estonian: Väga harvadel juhtudel on täheldatud vee omastamise vähenemist.
English: Wash hands after use.
Estonian: Pärast kasutamist pesta käsi.
English: Allergic reactions to these substances may occasionally be serious and therefore direct contact should be avoided.
Estonian: Allergilised reaktsioonid nimetatud ühendite suhtes võivad aeg-ajalt osutuda tõsiseks ja seetõttu tuleb otsest kontakti nendega vältida.
English: In particular, its activity has been demonstrated against the following microorganism:
Estonian: Täpsemalt on ravimi toimet näidatud järgmiste mikroorganismide korral:
English: SPECIAL WARNING(S), IF NECESSARY
Estonian: ERIHOIATUS(ED), KUI VAJALIK
English: Based on the data presented, the following self-life periods are considered acceptable:
Estonian: Esitatud andmete põhjal peetakse vastuvõetavaks järgmisi kõlblikkusaegu:
English: Protect from direct sunlight.
Estonian: Hoida kaitstult otsese päikesekiirguse eest.