FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of daclatasvir 60 mg tablet after a light meal resulted in no reduction in
Estonian: Daklatasviiri 60 mg tableti manustamine pärast kerget einet ei vähendanud daklatasviiri plasmakontsentratsiooni.
English: * Includes patients co-infected with human immunodeficiency virus (HIV).
Estonian: GT: genotüüp; CP: Child Pugh * Hõlmab ka patsiente kaasneva inimese immuunpuudulikkuse viiruse (human immunodeficiency virus,
English: Most patients (61%) had IL-28B rs12979860 non-CC genotypes.
Estonian: Enamikel patsientidel (61%) oli IL-28B rs12979860 mitte-CC
English: * Patients who had missing data at follow-up Week 12 were considered responders if their next available ** Cirrhosis status was not reported for four patients in the daclatasvir + pegIFN/RBV group.
Estonian: ** Maksatsirroosi staatust ei olnud registreeritud neljal patsiendil daklatasviiri + pegIFN/RBV rühmas.
English: Light green biconvex pentagonal of dimensions 9.1 mm x 8.9 mm, debossed tablet with "BMS" on one
Estonian: Heleroheline kaksikkumer viisnurkne tablett mõõtudega 9,1 mm x 8,9 mm, mille ühel küljel on pimetrükk „BMS” ja teisel küljel „215”.
English: Ribavirin Dosing Guidelines
Estonian: Ribaviriini annustamisjuhis
English: Daclatasvir in combination with sofosbuvir
Estonian: Daklatasviir kombineerituna sofosbuviiriga
English: Dizziness has been reported during treatment with Daklinza in combination with sofosbuvir, and dizziness, disturbance in attention, blurred vision and reduced visual acuity have been reported during treatment with Daklinza in combination with peginterferon alfa and ribavirin.
Estonian: Daklinza kasutamisel koos sofosbuviiriga on täheldatud uimasust; Daklinza kasutamisel koos alfapeginterferooni ja ribaviriiniga on täheldatud uimasust, tähelepanuhäireid, nägemise hägusust ja
English: Moderate inducers of CYP3A4
Estonian: mükobakterivastase ravimi CYP3A4
English: Detectable HCV RNA at end of treatment
Estonian: Viroloogiline ebaõnnestumine Määratav HCV RNA ravi lõpus
English: Since Daklinza is used in combination with other agents, the contraindications and warnings for those
Estonian: Kuna Daklinzat kasutatakse kombineerituna muude ravimitega, tuleb lähtuda muude ravimite vastunäidustustest ja nende kohta käivatest hoiatustest.
English: Pack size of 28 film-coated tablets in perforated unit dose blisters.
Estonian: Pakendi suurus on 28 õhukese polümeerikattega tabletti üheannuselistes perforeeritud blistrites Pakendi suurus on 28 õhukese polümeerikattega tabletti perforeerimata kalenderblistrites
English: Table 7: Treatment outcomes, daclatasvir in combination with sofosbuvir for 24 weeks, treatment-naïve patients with HCV genotype 2 or 3 in Study AI444040
Estonian: Ravi tulemused, daklatasviir kombineerituna sofosbuviiriga 24 nädala jooksul, varem ravimata patsiendid, HCV 2. või 3. genotüüp uuringus AI444040
English: There was no Y93H RAV present at baseline for genotype-3 infected patients treated for 12-weeks with sofosbuvir + daclatasvir + ribavirin, and thus SVR outcomes cannot
Estonian: 3. genotüübi infektsiooniga patsientidel, kes said 12 nädala vältel ravi sofosbuviiri + daklatasviiri + ribaviriiniga, puudus ravieelselt Y93H RAV ning seega ei saa SVR tulemusi hinnata.
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines
Estonian: Pärast ravi alustamist selliste ravimitega nagu Daklinza on mõnedel diabeediga patsientidel tekkinud madal veresuhkru tase (hüpoglükeemia).
English: PK trough levels for peginterferon alfa in patients who received peginterferon alfa, ribavirin, and daclatasvir were received peginterferon alfa, ribavirin,
Estonian: Alfa-peginterferooni farmakokineetilised parameetrid enne peginterferooni, ribaviriini ja daklatasviiri, olid samaväärsed peginterferooni, ribaviriini ja
English: Table 12: Treatment outcomes, daclatasvir in combination with sofosbuvir for 12 weeks, patients with HCV genotype 3 in Study ALLY-3 Treatment-naïve N=101
Estonian: Tabel 12: Ravi tulemused, daklatasviir kombineerituna sofosbuviiriga 12 nädala jooksul, HCV 3. genotüübiga patsiendid uuringus ALLY-3
English: Patients originally assigned to placebo and those in the daclatasvir group who did not achieve HCV RNA <LLOQ at Week 4 and undetectable at Week 10 continued pegIFN/RBV
Estonian: Algselt platseebot saama määratud patsiendid ja daklatasviiri ravirühma kuulunud patsiendid, kellel ei saavutatud 4. nädalal HCV RNA < LLOQ ja 10. nädalal tuvastamatut HCV RNA-d, jätkasid ravi pegIFN/RBV-ga kuni 48 ravinädala täitumiseni.
English: Daklinza 30 mg film-coated tablets Daklinza 60 mg film-coated tablets daclatasvir
Estonian: Daklinza 30 mg õhukese polümeerikattega tabletid Daklinza 60 mg õhukese polümeerikattega tabletid daklatasviir (daclatasvirum)
English: dabigatran etexilate, used to to prevent blood clots ketoconazole, itraconazole, posaconazole or voriconazole, used to treat fungal infections verapamil, diltiazem, nifedipine or amlodipine, used to decrease blood pressure rosuvastatin, atorvastatin, fluvastatin, simvastatin, pitavastatin or pravastatin, used to lower blood cholesterol oral contraceptives
Estonian: ketokonasool, itrakonasool, posakonasool või vorikonasool, mida kasutatakse seennakkuste ravis; verapamiil, diltiatseem, nifedipiin või amlodipiin, mida kasutatakse kõrge vererõhu ravis; rosuvastatiin, atorvastatiin, fluvastatiin, simvastatiin, pitavastatiin või pravastatiin, mida kasutatakse kolesteroolisisalduse langetamiseks; suukaudsed kontratseptiivid.
English: HCV/HBV (hepatitis B virus) co-infection
Estonian: HCV/HIV koinfektsioon (ALLY-2)
English: If you have any questions about your medicines, please ask your doctor or
Estonian: Kui teil on mis tahes lisaküsimusi oma ravimite kohta, pidage palun nõu oma arsti või apteekriga.
English: CP A
Estonian: 1b
English: Table 3: Treatment stopping rules in patients receiving Daklinza in combination with peginterferon alfa and ribavirin with inadequate on-treatment virologic response
Estonian: Ravi peatamise juhised Daklinza, alfa-peginterferooni ja ribaviriini kombinatsiooni saavatel patsientidel raviaegse ebapiisava viroloogilise ravivastuse
English: Median age was 55 years (range: 24 to 73); 90% of patients were white; 4% were black/African-American; 5% were Asian; 16% were Hispanic or Latino.
Estonian: 24...73); 90% patsientidest olid valgest rassist, 4% olid mustanahalised/afroameeriklased, 5% asiaadid, 16% hispaanlased või latiinod.
English: Bristol-Myers Squibb Pharmaceuticals uc
Estonian: Bristol-Myers Squibb Pharma EEIG
English: Skin and subcutaneous tissue disorders rash, alopecia, pruritus,
Estonian: Naha ja nahaaluskoe kahjustused lööve, alopeetsia, pruritus, nahakuivus
English: decreased appetite insomnia, irritability insomnia headache dizziness, migraine dizziness, migraine
Estonian: iiveldus, kõhulahtisus, kõhuvalu
English: Post-Liver Transplant N = 53
Estonian: Maksasiirdamise läbinud patsientide kohort N=53
English: Ribavirin Dosing Guideline
Estonian: Etraviriin Nevirapiin
English: If you take more Daklinza than you should
Estonian: Kui te lõpetate Daklinza võtmise
English: Patients treated with vitamin K antagonists
Estonian: Varfariin ja teised K-vitamiini
English: All 3 HCV/HIV co
Estonian: Teised HCV viirusevastased ravimid
English: Daclatasvir inhibits both viral RNA replication
Estonian: Daklatasviir inhibeerib P-gp ja BCRP
English: Expected due to inhibition of P-gp by
Estonian: Ootuspärane on, et daklatasviiri P-gp
English: Paediatric population
Estonian: Eripopulatsioonid
English: One patient with HCV genotype 2 infection was missing both post
Estonian: Ühel HCV 2. genotüübi infektsiooniga patsiendil puudusid mõlemad - nii 12. kui 24. nädala ravijärgsed andmed.
English: See package leaflet for further information.
Estonian: Teavitades aitate saada rohkem infot ravimi
English: Each film-coated tablet contains 30 mg of daclatasvir (as dihydrochloride).
Estonian: Üks õhukese polümeerikattega tablett sisaldab 30 mg daklatasviiri (divesinikkloriidina).
English: Table 13: Treatment outcomes, daclatasvir in combination with sofosbuvir and ribavirin for 24 weeks, HCV genotype 3 patients with cirrhosis in Study ALLY-3C Treatmentexperienced N=24
Estonian: Ravi tulemused, daklatasviir kombineerituna sofosbuviiri ja ribaviriiniga 24 nädala jooksul, HCV 3. genotüübi ja tsirroosiga patsiendid uuringus ALLY
English: NARCOTIC ANALGESICS Buprenorphine/naloxone, 8/2 mg to 24/6 mg once daily
Estonian: 8/2 mg kuni 24/6 mg üks kord ööpäevas individualiseeritud (daklatasviir 60 mg üks kord buprenorfiini/naloksooni stabiilse
English: Each film-coated tablet contains 60 mg of daclatasvir (as dihydrochloride).
Estonian: Üks õhukese polümeerikattega tablett sisaldab 60 mg daklatasviiri (divesinikkloriidina).
English: Biotransformation
Estonian: Embrüofetaalne areng
English: ↑ Daclatasvir AUC*: 2.10 (1.95, 2.26)
Estonian: ↔ Daklatasviir AUC: 1,12 (1,01, 1,26)
English: Daklinza + sofosbuvir + ribavirin for 12 weeks Daklinza + sofosbuvir +/- ribavirin for 24 weeks
Estonian: Daklinza + sofosbuviir + ribaviriin 12 nädalat Daklinza + sofosbuviir +/- ribaviriin 24 nädalat Daklinza + sofosbuviir +/- ribaviriin 24 nädalat (vt lõigud 4.4 ja 5.1)
English: Patients with HCV genotype 1, 2, 3, 4, 5 or 6 infection were eligible to enroll.
Estonian: Uuringus sobisid osalema HCV 1., 2., 3., 4.,
English: Daclatasvir was excreted into the milk of lactating rats with concentrations 1.7- to 2-fold maternal
Estonian: Daklatasviir eritus rottide rinnapiima kontsentratsioonis, mis oli emaslooma plasmakontsentratsioonist
English: Missed doses
Estonian: Varem ravimata
English: Expected due to CYP3A4 inhibition by
Estonian: Ootuspärane on, et botsepreviiri CYP3A4 inhibeeriva toime tõttu:
English: Expected due to CYP3A4 induction by
Estonian: Ootuspärane on, et naistepuna CYP3A4 indutseeriva toime tõttu: ↓ Daklatasviir
English: 600 mg daily 400 mg daily 200 mg daily Discontinue ribavirin
Estonian: 400 mg ööpäevas
English: The sofosbuvir resistance-associated substitution S282T emerged in only 1 non-SVR12 patient Emergent daclatasvir resistance-associated substitutions have been shown to persist for 3 years posttreatment and beyond for patients treated with daclatasvir-based regimens.
Estonian: On näidatud tekkinud daklatasviirresistentsusega seotud substitutsioonide püsimist 3 aastat pärast ravi ja kauem patsientidel, keda raviti daklatasviiri sisaldavate raviskeemidega.
English: if you are taking (by mouth or other ways that affect the whole body) any of the following medicines - phenytoin, carbamazepine, oxcarbazepine or phenobarbital, used to treat epileptic seizures - rifampicin, rifabutin or rifapentine, antibiotics used to treat tuberculosis - dexamethasone, a steroid used to treat allergic and inflammatory diseases - medicines containing St. John's wort (Hypericum perforatum, a herbal preparation).
Estonian: - rifampitsiin, rifabutiin või rifapentiin - tuberkuloosi raviks kasutatavad antibiootikumid; - deksametasoon - steroidhormoon, mida kasutatakse allergiliste ja põletikuliste haiguste korral; - naistepuna (Hypericum perforatum, ravimtaim) sisaldavad ravimid.
English: No dose adjustment of Daklinza is required for patients with any degree of renal impairment (see
Estonian: Mis tahes staadiumis neerupuudulikkusega patsientidel ei ole Daklinza annuse kohandamine vajalik
English: Cmax: 0.95 (0.89, 1.02) Cmin: 1.17 (1.10, 1.24)
Estonian: ↔ Daklatasviir AUC: 0,84 (0,73, 0,96) Cmax: 0,64 (0,54, 0,77) Cmin: 0,92 (0,80, 1,05)
English: Discontinue peginterferon alfa and ribavirin (treatment with Daklinza is complete at week 24) Dose recommendation for concomitant medicines Strong inhibitors of cytochrome P450 enzyme 3A4 (CYP3A4)
Estonian: Annustamissoovitused samaaegselt kasutatavate ravimite kohta Ensüümi tsütokroom P450 3A4 (CYP3A4) tugevad inhibiitorid Daklinza annust tuleb vähendada 30 mg-ni üks kord päevas manustamisel koos CYP3A4 tugevate inhibiitoritega.
English: daclatasvir + pegIFN/RBV
Estonian: daklatasviir + pegIFN/RBV N=12
English: The 211 patients had a median age of 54 years (range: 20 to 70); 83% were white; 12% were black/African-American; 2% were Asian; 20% were Hispanic or Latino.
Estonian: Ravitud patsientide mediaanvanus oli 50 aastat (vahemik: 18 kuni 67); 79% patsientidest oli valgest rassist, 13% olid mustanahalised/afroameeriklased, 1% asiaadid, 9% hispaanlased või latiinod.
English: *PK parameters for daclatasvir when administered with peginterferon alfa and ribavirin in this study were similar to those observed in a study of HCV
Estonian: ribaviriiniga manustatud daklatasviiri farmakokineetilised parameetrid olid selles uuringus sarnased tulemustega, mida täheldati HCV-infektsiooniga uuritavatel, kellele manustati monoteraapiana.
English: Cases of severe bradycardia and heart block have been observed when Daklinza is used in combination with sofosbuvir and concomitant amiodarone and/or other drugs that lower heart rate (see
Estonian: Daklinza kasutamisel kombinatsioonis sofosbuviiriga ning samaaegselt amiodarooniga ja/või koos südame löögisagedust vähendavate teiste ravimitega esines raske bradükardia ja südameblokaadi juhtumeid (vt lõigud 4.4 ja 4.5).
English: *results are dose-normalised to 60 mg
Estonian: CYP3A4 induktsioon efavirensi poolt *Tulemused on normaliseeritud vastavalt 60 mg annusele.
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Estonian: RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAV
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with atazanavir/ritonavir, atazanavir/cobicistat or other strong inhibitors of CYP3A4.
Estonian: Manustatuna koos atasanaviiri/ritonaviiri, atasanaviiri/kobitsistaadi või muude CYP3A4 tugevate inhibiitoritega tuleb Daklinza annust vähendada 30 mg-ni üks kord ööpäevas.
English: Interaction not studied for this fixed Expected due to CYP3A4 inhibition by
Estonian: Koostoimet ei ole uuritud Ootuspärane on, et etraviriini või nevirapiini CYP3A4 indutseeriva toime tõttu: ↓ Daklatasviir
English: Elimination
Estonian: Imendumine
English: Tabulated list of adverse reactions
Estonian: Tabelina esitatud kõrvaltoimed
English: The AUC associated with this dose in males is 19-fold the clinical
Estonian: Isasloomadel oli sellega seotud annuse AUC 19-kordne kliinilise plasmakontsentratsiooni AUC.
English: Table 5: Adverse reactions in clinical studies System Organ Class
Estonian: Kõrvaltoimed kliinilistes uuringutes
English: Your doctor will tell you how long you need to continue taking your tablets.
Estonian: Arst ütleb teile, kui kaua te peate tablettide võtmist jätkama.
English: The duration of the active treatment period was only 8 weeks.
Estonian: Aktiivravi kestus uuringutes oli üksnes 8 nädalat.
English: Show them your pack of tablets.
Estonian: Näidake neile oma tabletikarpi.
English: • Famvir has been prescribed for you.
Estonian: • Famvir on välja kirjutatud teile.
English: However, the data were considered supportive.
Estonian: Selle uuringu andmeid võib siiski pidada toetavateks.
English: All other adverse reactions were added during postmarketing.
Estonian: Kõik teised kõrvaltoimed lisati turustamisjärgselt.
English: Always take Famvir exactly as your doctor has told you.
Estonian: Võtke Famvir'i alati täpselt nii, nagu arst on teile rääkinud.
English: There were 48 patients enrolled and treated.
Estonian: Uuringusse võeti ja ravi said 48 patsienti.
English: Section 4.6 was updated accordingly.
Estonian: Selle alusel ajakohastati ka jaotist 4.6.
English: - If you have kidney problems (or have had them before).
Estonian: - Kui teil on probleeme neerudega (või teil on varem esinenud).
English: 2 - 4, rue Lionel Terray 92500 Rueil-Malmaison France
Estonian: 2 - 4, rue Lionel Terray 92500 Rueil-Malmaison Prantsusmaa
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Estonian: Palun informeerige oma arsti või apteekrit, kui te kasutate või olete hiljuti kasutanud mingeid muid ravimeid, kaasa arvatud ravimtaimi ja ilma retseptita ostetud ravimeid.
English: - If you have problems with your body's immune system.
Estonian: - Kui teil on probleeme organismi immuunsüsteemiga.
English: 12th Km National Road No. 1 GR-144 51 Metamorphosis Greece
Estonian: 12th Km National Road No. 1 GR-144 51 Metamorphosis Kreeka
English: 6800 LZ Arnhem The Netherlands
Estonian: 6800 LZ Arnhem Holland
English: Like all medicines, Famvir can cause side effects, although not everybody gets them.
Estonian: Nagu kõik ravimid, võib ka Famvir põhjustada kõrvaltoimeid, kuigi kõigil neid ei teki.
English: 2100 Kopenhagen Ø Denmark
Estonian: 2100 Kopenhagen Ø Taani
English: Very common side effects - Headache
Estonian: Väga sagedased kõrvaltoimed - peavalu
English: Within the EEA, the 750mg tablet strength is currently approved only in Ireland, UK and Spain.
Estonian: Euroopa Majanduspiirkonna riikidest on 750 mg tablettidel hetkel müügiluba ainult Iirimaal, Ühendkuningriigis ja Hispaanias.
English: Famciclovir should only be used during pregnancy when the potential benefits of treatment outweigh the potential risks.
Estonian: Famtsükloviiri võib raseduse ajal kasutada vaid juhul, kui ravi võimalik kasu ületab raviga kaasnevad võimalikud riskid.
English: Of these, only 27 completed the study.
Estonian: Neist 27 lõpetasid uuringu mõlemad perioodid.
English: The design of Study 007 was considered to have some deficiencies.
Estonian: Uuringu 007 ülesehituses leiti mõningaid puudujääke.
English: However, the selection of placebo controls for both studies was questionable.
Estonian: Samas on platseebokontrolli kasutamine mõlemas uuringus küsitav.
English: - If you have liver problems.
Estonian: - Kui teil on probleeme maksaga.
English: No clinically significant interactions have been identified.
Estonian: Kliiniliselt olulisi koostoimeid ei ole tuvastatud.
English: This section was updated to remove patient populations not studied as this should be mentioned in section 4.4.
Estonian: Jaotist ajakohastati, eemaldades patsiendipopulatsioonid, kellel ei ole uuringuid tehtud, sest see teave peab olema esitatud jaotises 4.4.
English: Do not drive or use machines if you have any of these symptoms while taking Famvir.
Estonian: Ärge juhtige autot ega kasutage masinaid, kui teil esineb Famvir'i võtmise ajal mõni neist sümptomitest.
English: The 10-day treatment duration was chosen to maximize the efficacy in this ‘at risk' population.
Estonian: 10-ööpäevane raviperiood valiti selleks, et saavutada nn riskialtil populatsioonil maksimaalne efektiivsus.
English: Metabolism and elimination
Estonian: Ainevahetus ja eliminatsioon
English: It is especially important that you tell your doctor or pharmacist if you are taking any of the following medicines:
Estonian: Eriti oluline on informeerige arsti või apteekrit, kui te võtate alljärgnevaid ravimeid:
English: Partly this difference may be due to differences in renal function between the two age groups.
Estonian: See erinevus võib osaliselt olla tingitud erinevustest kahe vanuserühma neerutalitluses.
English: This is important to prevent you passing the infection on to others.
Estonian: See aitab vältida nakkuse edasikandumist teistele.
English: Novartis Hungaria Kft. Bartók Béla út 43-47 H-1114 Budapest Hungary
Estonian: Novartis Hungaria Kft. Bartók Béla út 43-47 H-1114 Budapest Ungari
English: Recently two papers on human liver aldehyde oxidase inhibition in in vitro investigations were published (Obach 2004; Obach, et al 2004).
Estonian: Hiljuti avaldati kaks publikatsiooni, mis käsitlevad inimese maksa aldehüüdioksüdaasi inhibeerimist in vitro uuringutes (Obach 2004; Obach et al., 2004).
English: Pharmacotherapeutic group: Nucleosides and nucleotides excluding reverse transcriptase inhibitors, ATC code: JO5AB09
Estonian: Farmakoterapeutiline grupp: Nukleosiidid ja nukleotiidid, välja arvatud pöördtranskriptaasi inhibiitorid, ATC-kood: JO5AB09
English: Famvir can cause dizziness, drowsiness or confusion.
Estonian: Famvir võib põhjustada pearinglust, uimasust või segasust.
English: Famvir is not to be used during pregnancy unless clearly necessary.
Estonian: Famvir'i ei tohi raseduse ajal kasutada, kui selleks ei ole selget vajadust.
English: This finding was reversible and has also been observed with other substances of this class.
Estonian: See näht osutus aga pöörduvaks ja seda on täheldatud ka teiste samasse klassi kuuluvate ainete puhul.
English: Largo Umberto Boccioni 1 I-21040 Origgio Italy
Estonian: Largo Umberto Boccioni 1 I-21040 Origgio Itaalia
English: It was noted that this dose is also in line with current literature recommendations (Dworkin RH et al, Clin.
Estonian: Inimravimite komitee märkis, et see annus vastab ka kirjanduses esitatud praegustele ravisoovitustele (Dworkin, R. H. et al., Clin.
English: HIV: human immunodeficiency virus
Estonian: HIV: inimese immuunpuudulikkuse viirus populatsioonis.
English: Famvir stops the virus from spreading in the body so that healing can occur faster.
Estonian: Famvir peatab viiruse leviku organismis, nii et paranemine toimub kiiremini.
English: - The daily dose and length of treatment will depend on the type of viral infection you have - see below.
Estonian: - Ööpäevane annus ja ravi pikkus sõltuvad sellest, mis tüüpi viirusnakkus teil on - vt all pool.
English: Initiation of treatment is recommended as soon as possible after onset of prodromal symptoms (e.g. tingling, itching, burning, pain) or lesions.
Estonian: Raviga soovitatakse alustada võimalikult kohe pärast prodromaalsete sümptomite (nt surin, sügelus, kipitus, valu) või lööbe teket.
English: Famciclovir was considered equivalent to aciclovir if the upper limit of the 2-sided 95% confidence interval was less than 15%.
Estonian: Famtsikloviiri võis pidada atsikloviiriga samaväärseks, kui kahepoolse 95% usaldusvahemiku ülemine piir oli alla 15%.
English: In line with the information in section 5.3, this section was updated, in particular regarding male fertility.
Estonian: Jaotist ajakohastatikooskõlas jaotise 5.3 teabega, eriti meeste viljakuse teabe osas.
English: A recent publication, by Money B et al, supported the inclusion of this warning, which was endorsed by the CHMP.
Estonian: Ka hiljutine Money, B. et al. publikatsioon kinnitab selle hoiatuse vajalikkust, mille inimravimite komitee ka kinnitas.
English: Novartis Farmacéutica S.A. Gran Via de les Corts Catalanes 764.E-08013 Barcelona Spain
Estonian: Novartis Farmacéutica S.A. Gran Via de les Corts Catalanes 764.E-08013 Barcelona Hispaania
English: Nausea, vomiting.
Estonian: Iiveldus, oksendamine
English: What Famvir looks like and contents of the pack
Estonian: Kuidas Famvir välja näeb ja pakendi sisu
English: There is a limited amount of data (less than 300 pregnancy outcomes) from the use of famciclovir in pregnant women.
Estonian: Famtsükloviiri kasutamise kohta rasedatel on vähe andmeid (vähem kui 300 raseduse juhtu).
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF FAMVIR AND ASSOCIATED NAMES (SEE ANNEX I)
Estonian: FAMVIRi JA SARNASTE NIMETUSTE (vt I lisa) TEADUSLIKU HINDAMISE ÜLDKOKKUVÕTE
English: Characteristics in special populations
Estonian: Omadused eripopulatsioonides
English: All patients who initiated study medication during Period 1 were included in the ITT analysis for that period.
Estonian: Kõik patsiendid, kes alustasid 1. uuringuperioodil ravimi võtmist, kaasati vastava perioodi ravikavatsuslikku analüüsi.
English: The minimum period of reassessment should include two recurrences.
Estonian: Ümberhindamise ajavahemik peab hõlmama minimaalselt kahte haiguse korduvjuhtu.
English: Your doctor will prescribe the correct dose for you.
Estonian: Arst määrab teile vajaliku annuse.
English: - If you have or have had kidney problems, your doctor may decide to give you a lower dose of Famvir.
Estonian: - Kui teil esineb või on esinenud probleeme neerudega, võib arst määrata teile Famvir'i väiksemas annuses.
English: Rare side effects - Hallucinations (seeing or hearing things that are not really there) - Yellowing of the skin and/or eyes - Low platelet count
Estonian: Harva esinevad kõrvaltoimed - hallutsinatsioonid (asjade nägemine või kuulmine, mida ei ole tegelikult olemas) - naha ja/või silmavalgete kollasus - madal trombotsüütide arv