FrancophonIA/ELRC3.0 huggingface dataset:
English: Imnovid 3 mg hard capsules: Dark blue opaque cap and green opaque body, with “POML 3 mg” written on them.
Estonian: Imnovid 3 mg kõvakapslid: tumesinine läbipaistmatu kapslikaas ja roheline läbipaistmatu kapslikeha, millele on kirjutatud “POML 3 mg”.
English: • Each capsule contains 1 mg of pomalidomide.
Estonian: • Iga kapsel sisaldab 1 mg pomalidomiidi.
English: • See the leaflet that comes with dexamethasone for further information on its use and effects.
Estonian: • Täpsema teabe saamiseks deksametasooni kasutamise ja toimete kohta lugege selle pakendi infolehte.
English: • Description of the PPP and categorisation of patients based on sex and childbearing potential o Algorithm for implementation of PPP o Definition of women of childbearing potential (WCBP) and actions the physician should take if unsure
Estonian: • Raseduse ennetusprogrammi (PPP) kirjeldus ja patsientide rühmitamine soo ja rasestumisvõime alusel:
English: Mean normalised AUC exposure to pomalidomide increased by 35.8% with a 90% CI [7.5% to 70.0%] in severe renal impairment patients requiring dialysis (CrCl <30mL/minute requiring dialysis) compared to patients with normal renal function.
Estonian: Dialüüsi vajavatel raske neerukahjustusega patsientidel (kreatiniini kliirens < 30 ml/min, vajab dialüüsi) suurenes pomalidomiidi süsteemne saadavus (keskmine normaliseeritud AUC) 35,8%, (90% usaldusvahemikuga 7,5% kuni 70,0%), võrreldes normaalse neerutalitlusega patsientidega.
English: Dark blue opaque cap and yellow opaque body, imprinted “POML” in white ink and “1 mg” in black ink, size 4 gelatin hard capsule.
Estonian: Tumesinine läbipaistmatu kapslikaas ja kollane läbipaistmatu kapslikeha, millele on trükitud valge tindiga „POML“ ja musta tindiga „1 mg“, želatiinist kõvakapsel, suurus 4.
English: Imnovid 1 mg hard capsule:
Estonian: Imnovid 1 mg kõvakapsel:
English: Imnovid 2 mg hard capsule:
Estonian: Imnovid 2 mg kõvakapsel:
English: Imnovid 4 mg hard capsule:
Estonian: Imnovid 4 mg kõvakapsel:
English: • Documentation of childbearing potential status
Estonian: • dokumenteeritud fertiilsusseisund;
English: Clostridium difficile colitis Respiratory tract infection Lower respiratory tract infection Lung infection
Estonian: Clostridium difficile'st põhjustatud koliit; hingamisteede infektsioon; alumiste hingamisteede infektsioon; kopsuinfektsioon; gripp; bronhioliit; kuseteede infektsioon.
English: • Description of the PPP
Estonian: • raseduse ennetusprogrammi (PPP) kirjeldus,
English: Imnovid 3 mg hard capsule:
Estonian: Imnovid 3 mg kõvakapsel:
English: Pomalidomide interruption or discontinuation should be considered for Grade 2-3 skin rash.
Estonian: 2.-3. astme nahalööbe korral tuleb kaaluda ravi katkestamist või lõpetamist pomalidomiidiga.
English: Imnovid 2 mg hard capsules pomalidomide
Estonian: Imnovid 2 mg kõvakapslid
English: Fatigue
Estonian: Annusetase
English: In patients receiving combination therapy with pomalidomide in clinical studies, thrombocytopenia occurred in 27.0-36.7% of patients.
Estonian: Trombotsütopeenia tekkis 27,0%...36,7% patsientidest, kes said kliinilistes uuringutes kombinatsioonravi pomalidomiidiga.
English: Decrease by one dose level if symptoms persist.
Estonian: Sümptomite püsimisel vähendada annust ühe taseme võrra.
English: • Each capsule contains 4 mg of pomalidomide.
Estonian: • Iga kapsel sisaldab 4 mg pomalidomiidi.
English: KaplanMeier curve for PFS for the ITT population is provided in Figure 1.
Estonian: Joonisel 1 on esitatud ravikavatsusliku populatsiooni progressioonivaba elulemuse Kaplani-Meieri kõver.
English: Very Common Neutropenia Thrombocytopenia Leucopenia Anaemia
Estonian: Väga sage: neutropeenia; trombotsütopeenia; leukopeenia; aneemia.
English: • Each capsule contains 2 mg of pomalidomide.
Estonian: • Iga kapsel sisaldab 2 mg pomalidomiidi.
English: What Imnovid looks like and contents of the pack Imnovid 1 mg hard capsules: Dark blue opaque cap and yellow opaque body, with “POML 1 mg” written on them.
Estonian: Imnovid 1 mg kõvakapslid: tumesinine läbipaistmatu kapslikaas ja kollane läbipaistmatu kapslikeha, millele on kirjutatud “POML 1 mg”.
English: Deep vein thrombosis Hypotension Hypertension
Estonian: Vaskulaarsed häired Sage: süvaveeni tromboos; hüpotensioon; hüpertensioon.
English: Hepatic disorders
Estonian: Hematoloogilised juhud
English: Imnovid 1 mg hard capsules pomalidomide
Estonian: Imnovid 1 mg kõvakapslid
English: Imnovid 3 mg hard capsules pomalidomide
Estonian: Imnovid 3 mg kõvakapslid
English: • Shingles.
Estonian: • segasus;
English: Patients should not donate blood, semen or sperm during treatment (including during dose interruptions) and for 7 days following discontinuation of pomalidomide.
Estonian: Ravi ajal (sealhulgas ravikatkestuste ajal) ja 7 päeva jooksul pärast ravi lõppu pomalidomiidiga ei ole patsientidel lubatud olla vere- ega spermadoonor.
English: Second primary malignancies, such as non-melanoma skin cancer, have been reported in patients receiving pomalidomide (see section 4.8).
Estonian: Pomalidomiidiga ravitavatel patsientidel on teatatud teistest primaarsetest pahaloomulistest kasvajatest, näiteks mittemelanoomsest nahavähist (vt lõik 4.8).
English: • Each capsule contains 3 mg of pomalidomide.
Estonian: • Iga kapsel sisaldab 3 mg pomalidomiidi.
English: Titanium dioxide (E171) Indigotine (E132) Yellow iron oxide (E172) White and black ink
Estonian: Imnovid 1 mg kõvakapslid želatiin titaandioksiid (E171) indigotiin (E132) kollane raudoksiid (E172) valge ja must tint
English: In patients receiving combination therapy with pomalidomide in clinical studies, infection occurred in 55.0-80.2% of patients (24.0-30.9% Grade 3 or 4).
Estonian: Infektsioon tekkis 55,0%...80,2% (3. või 4. aste 24,0%...30,9%) patsientidest, kes said kliinilistes uuringutes kombinatsioonravi pomalidomiidiga.
English: Low-dose dexamethasone (20 mg/day [≤ 75 years old] or 10 mg/day [> 75 years old]) was administered to patients in both study arms on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle for Cycles 1 to 8; and on Days 1, 2, 8 and 9 of each subsequent 21-day cycle from Cycles 9 onwards.
Estonian: Väikeses annuses deksametasooni (≤ 75-aastastele 20 mg ööpäevas või > 75-aastastele 10 mg ööpäevas) manustati mõlema uuringurühma patsientidele 1…8.
English: In patients receiving combination therapy with pomalidomide in clinical studies, neutropenia occurred in up to 46.8% of patients (41.7% Grade 3 or 4).
Estonian: Neutropeenia tekkis kuni 46,8% (3. või 4. aste 41,7%) patsientidest, kes said kliinilistes uuringutes kombinatsioonravi pomalidomiidiga.
English: Imnovid 4 mg hard capsules pomalidomide
Estonian: Imnovid 4 mg kõvakapslid
English: Dark blue opaque cap and orange opaque body, imprinted “POML 2 mg” in white ink, size 2 gelatin hard capsule.
Estonian: Tumesinine läbipaistmatu kapslikaas ja oranž läbipaistmatu kapslikeha, millele on trükitud valge tindiga „POML 2 mg“, želatiinist kõvakapsel, suurus 2.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Estonian: Kuidas Imnovid välja näeb ja pakendi sisu
English: Titanium dioxide (E171) Indigotine (E132) Yellow iron oxide (E172) White ink
Estonian: Imnovid 3 mg kõvakapslid želatiin titaandioksiid (E171) indigotiin (E132) kollane raudoksiid (E172) valge tint
English: Dark blue opaque cap and blue opaque body, imprinted “POML 4 mg” in white ink, size 2 gelatin hard capsule.
Estonian: Tumesinine läbipaistmatu kapslikaas ja sinine läbipaistmatu kapslikeha, millele on trükitud valge tindiga „POML 4 mg“, želatiinist kõvakapsel, suurus 2.
English: How to store Imnovid Keep this medicine out of the sight and reach of children.
Estonian: Hoidke seda ravimit laste eest varjatud ja kättesaamatus kohas.
English: • Pregnancy.
Estonian: • lööbed;
English: Platelet count return to ≥ 50 x 109/l
Estonian: Trombotsüütide arvu taastumine ≥ 50 x 10
English: Instructions for dose modification for dexamethasone related adverse reactions are outlined in Table 4.
Estonian: Deksametasooni annuse muutmine või ravi katkestamine Juhised annuse muutmiseks deksametasooniga seotud kõrvaltoimete korral on tabelis 4.
English: If you become pregnant despite the prevention measures: • you must stop the treatment immediately and talk to your doctor straight away.
Estonian: • peate kohe ravi katkestama ja ütlema seda oma arstile.
English: Angioedema and severe dermatologic reactions including SJS, TEN and DRESS have been reported with the use of pomalidomide (see section 4.8).
Estonian: Pomalidomiidiga seoses on teatatud angioödeemist ja rasketest nahareaktsioonidest, k.a Stevensi-Johnsoni sündroom, toksiline epidermaalne nekrolüüs ja DRESS (vt lõik 4.8).
English: Dark blue opaque cap and green opaque body, imprinted “POML 3 mg” in white ink, size 2 gelatin hard capsule.
Estonian: Tumesinine läbipaistmatu kapslikaas ja roheline läbipaistmatu kapslikeha, millele on trükitud valge tindiga „POML 3 mg“, želatiinist kõvakapsel, suurus 2.
English: Each hard capsule contains 1 mg of pomalidomide.
Estonian: Üks kõvakapsel sisaldab 1 mg pomalidomiidi.
English: Bortezomib (1.3 mg/m2/dose) was administered to patients in both study arms on Days 1, 4, 8 and 11 of a 21-day cycle for Cycles 1 to 8; and on Days 1 and 8 of a 21-day cycle for Cycles 9 and onwards.
Estonian: Bortesomiibi (1,3 mg/m2/annus) manustati mõlema uuringurühma patsientidele 1…8.
English: • The printing ink contains: white ink - shellac, titanium dioxide (E171), simeticone, propylene glycol (E1520) and ammonium hydroxide (E527).
Estonian: • Trükitint sisaldab: valge tint - šellak, titaandioksiid (E171), simetikoon, propüleenglükool
English: • Post-authorisation efficacy study (PAES) MM-007: In order to further investigate the efficacy of pomalidomide in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide, the MAH should submit the final analysis of OS from the phase 3, randomized, open label study MM-007.
Estonian: Müügiloa hoidja peab esitama 3. faasi juhuslikustatud avatud uuringu MM-007 üldise elulemuse lõpliku analüüsi, et uurida edasi pomalidomiidi efektiivsust kombinatsioonis bortesomiibi ja deksametasooniga hulgimüeloomi ravis täiskasvanud patsientidel, kellel on varem kasutatud vähemalt üht lenalidomiidi sisaldavat raviskeemi.
English: Common Febrile neutropenia Leucopenia Lymphopenia
Estonian: Sage: febriilne neutropeenia; leukopeenia; lümfopeenia.
English: However, dose interruption / resumption decisions are at physician's discretion per the current Summary of Product Characteristics (SmPC).
Estonian: Arst peab siiski tegema otsuse annustamise katkestamise või taasalustamise kohta, lähtudes kehtivast ravimi omaduste kokkuvõttest.
English: Bronchopneumonia Respiratory tract infection Upper respiratory tract infection
Estonian: Väga sage: kopsupõletik; bronhiit; ülemiste hingamisteede infektsioon; ülemiste hingamisteede viirusinfektsioon.
English: Peripheral sensory neuropathy Peripheral sensorimotor neuropathy
Estonian: Sage: minestamine; perifeerne sensoorne neuropaatia; perifeerne sensomotoorne neuropaatia.
English: Embryo-foetal development
Estonian: Embrüo ja loote areng
English: Bronchiolitis
Estonian: Naatriumisisaldus
English: Tremor
Estonian: Trükitint
English: • Abnormal liver test.
Estonian: • munajuhade ligeerimine,
English: Very Common Neutropenia Thrombocytopenia Anaemia
Estonian: Väga sage: neutropeenia; trombotsütopeenia; aneemia.
English: Common Febrile neutropenia Lymphopenia
Estonian: Sage: febriilne neutropeenia; lümfopeenia.
English: EU/1/13/850/007 (Pack size of 14 hard capsules) EU/1/13/850/003 (Pack size of 21 hard capsules)
Estonian: EU/1/13/850/007 (pakendis on 14 kõvakapslit) EU/1/13/850/003 (pakendis on 21 kõvakapslit)
English: EU/1/13/850/006 (Pack size of 14 hard capsules) EU/1/13/850/002 (Pack size of 21 hard capsules)
Estonian: EU/1/13/850/006 (pakendis on 14 kõvakapslit) EU/1/13/850/002 (pakendis on 21 kõvakapslit)
English: EU/1/13/850/008 (Pack size of 14 hard capsules) EU/1/13/850/004 (Pack size of 21 hard capsules)
Estonian: EU/1/13/850/008 (pakendis on 14 kõvakapslit) EU/1/13/850/004 (pakendis on 21 kõvakapslit)
English: Common Blood uric acid increased
Estonian: Sage: vere kusihappesisalduse tõus.
English: Each hard capsule contains 4 mg of pomalidomide.
Estonian: Üks kõvakapsel sisaldab 4 mg pomalidomiidi.
English: Cardiac failure Atrial fibrillation Myocardial infarction
Estonian: Sage: südamepuudulikkus; kodade virvendus; müokardiinfarkt.
English: Each hard capsule contains 2 mg of pomalidomide.
Estonian: Üks kõvakapsel sisaldab 2 mg pomalidomiidi.
English: EU/1/13/850/005 (Pack size of 14 hard capsules) EU/1/13/850/001 (Pack size of 21 hard capsules)
Estonian: EU/1/13/850/005 (pakendis on 14 kõvakapslit) EU/1/13/850/001 (pakendis on 21 kõvakapslit)
English: • Being sick (vomiting).
Estonian: • nägemise hägustumine (kae);
English: • Safety advice for women of childbearing potential o The need to avoid foetal exposure o Description of the PPP o Need for effective contraception (even if woman has amenorrhoea) and definition of effective contraception
Estonian: • kondoomi kasutamise vajadus vahekorras raseda või rasestumisvõimelise naispartneriga, kes ei kasuta rasestumisvastast vahendit (isegi juhul, kui mehele on tehtud vasektoomia),
English: PFS (months) Mediana time (95% CI) b HR c (95% CI), p-valued ORR, n (%) sCR
Estonian: (95% usaldusvahemik), p-väärtus d
English: • Obligation to conduct post-authorisation measures
Estonian: • Tervishoiuspetsialisti kohustused pomalidomiidi väljakirjutamisel:
English: Each hard capsule contains 3 mg of pomalidomide.
Estonian: Üks kõvakapsel sisaldab 3 mg pomalidomiidi.
English: Talk to your doctor, pharmacist or nurse before taking Imnovid if:
Estonian: Hoiatused ja ettevaatusabinõud Enne Imnovid'i võtmist pidage nõu oma arsti, apteekri või meditsiiniõega:
English: • National specific requirements agreed with the National Competent Authority regarding: o Distribution of the product o To ensure that all appropriate measures have been performed prior to pomalidomide being dispensed
Estonian: • riikliku pädeva asutusega kokku lepitud riiklikud erinõuded järgmistes küsimustes:
English: Gastrointestinal haemorrhage
Estonian: Kasvaja lahustussündroom
English: • Low blood levels of magnesium (hypomagnesaemia), which may cause tiredness, generalised weakness, muscle cramps, irritability and may result in low blood levels of calcium (hypocalcaemia), which may cause numbness and, or tingling of hands, feet, or lips, muscle cramps, muscle weakness, light-headedness, confusion.
Estonian: üldist nõrkust, lihaskrampe ja ärrituvust ning võib kutsuda esile vere madalat kaltsiumitaset
English: Common Hypotension Hypertension
Estonian: Sage: hüpotensioon; hüpertensioon.
English: Dyspepsia ≥ Grade 3
Estonian: Düspepsia ≥ 3. aste
English: Upper respiratory tract infection Respiratory tract infection Lower respiratory tract infection Lung infection
Estonian: Clostridium difficile'st põhjustatud koliit; bronhiit; ülemiste hingamisteede infektsioon; hingamisteede infektsioon; alumiste hingamisteede infektsioon kopsuinfektsioon; gripp; bronhioliit; kuseteede infektsioon.
English: What Imnovid is
Estonian: Mis ravim on Imnovid
English: 21 hard capsules.
Estonian: 14 kõvakapslit 21 kõvakapslit
English: Ref. EMEA/409402/2009 EMEA/H/C/995
Estonian: London, 25. juuni 2009 Viide: EMEA/455034/2009 EMEA/H/C/995
English: What is Factive?
Estonian: Mis on Factive?
English: When these enzymes are blocked, the bacteria cannot multiply and they eventually die.
Estonian: Kui need ensüümid on blokeeritud, ei saa bakterid paljuneda ja lõpuks hävivad.
English: The application was at day 196 when the company withdrew.
Estonian: Taotluse menetlemine oli kestnud 196 päeva, kui ettevõte võttis taotluse tagasi.
English: The seven-day treatment was not considered acceptable because of the risk of side effects.
Estonian: 7-päevast ravi ei peetud kõrvalnähtude riski tõttu vastuvõetavaks.
English: • mild or moderate community-acquired pneumonia (an infection of the lungs that is caught outside of hospital);
Estonian: • kerge või mõõdukas keskkonnatekkeline pneumoonia (kopsuinfektsioon, mis tekib patsiendil väljaspool haiglat);
English: Factive is a medicine that contains the active substance gemifloxacin.
Estonian: Factive on ravim, mis sisaldab toimeainena gemifloksatsiini.
English: It is expected to work by blocking the action of two bacterial enzymes called DNA gyrase and topoisomerase IV, which are needed to make and repair bacterial DNA.
Estonian: Selle toime seisneb eeldatavasti kahe ensüümi, DNA-güraasi ja topoisomeraas-IV blokeerimises, mida vajatakse bakterite DNA replikatsioonil ja parandamisel.
English: Questions and answers on the withdrawal of the marketing authorisation application for Factive gemifloxacin
Estonian: Teave müügiloa taotluse tagasivõtmise kohta Factive gemifloksatsiin
English: Factive was expected to be used to treat the following bacterial infections in adults:
Estonian: Factivet kavatseti kasutada täiskasvanud patsientide järgmiste bakterinfektsioonide raviks:
English: The main measures of effectiveness for the studies were based on the number of patients who got better after treatment.
Estonian: Uuringutes oli efektiivsuse põhinäitaja nende patsientide arv, kelle seisund oli ravi järel parem kui enne ravi.
English: The Committee also noted that the information presented did not support the use of Factive for chronic bronchitis because no studies were carried out to investigate whether Factive was better than other treatments for this type of infection and because there were problems with the studies that were performed.
Estonian: Komitee märkis ka, et esitatud teave ei toetanud Factive kasutamist kroonilise bronhiidi korral, sest ei tehtud uuringuid, mis oleksid võrrelnud Factive-ravi teiste selle infektsiooni raviviisidega, ning samuti oli probleeme tehtud uuringutega.
English: On 17 June 2009, Menarini International Operations Luxembourg S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Factive, for the treatment of the bacterial infections, communityacquired pneumonia and acute exacerbation of chronic bronchitis.
Estonian: 17. juunil 2009 teatas Menarini International Operations Luxembourg S.A. ametlikult inimravimite komiteele oma soovist võtta tagasi bakterinfektsioonide, keskkonnatekkelise pneumoonia ning kroonilise bronhiidi ägenemise raviks kasutada kavatsetud ravimi Factive müügiloa taotlus.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Factive?
Estonian: Kuidas mõjutab tagasivõtmine praegu Factive kliinilistes uuringutes või eriloaga kasutamise programmides osalevaid patsiente?
English: The CHMP was concerned that Factive may be more genotoxic (harmful to the DNA, the genetic material in cells) and that it may therefore cause more damage to the DNA than other fluoroquinolones.
Estonian: Inimravimite komitee arvates võib Factive olla genotoksilisem (kahjulik rakkude pärilikkuskandjale DNA-le) kui teised fluorokinoloonid ja võib seetõttu kahjustada DNA-d neist rohkem.
English: The active substance in Factive, gemifloxacin, is an antibiotic belonging to the class ‘fluoroquinolones'.
Estonian: Factive toimeaine gemifloksatsiin on fluorokinoloonide klassi kuuluv antibiootikum.
English: • acute exacerbation (flare-up) of chronic bronchitis (inflammation of the airways in the lungs).
Estonian: • kroonilise bronhiidi (kopsubronhide põletiku) ägenemine.
English: How is Factive expected to work?
Estonian: Milline on Factive eeldatav toime?
English: In another study of patients with communityacquired pneumonia, 510 adults were given Factive either as a five- or seven-day treatment.
Estonian: Veel ühes keskkonnatekkelise pneumooniaga patsientide uuringus anti 510 täiskasvanule Factivet 5- või 7-päevase ravina.
English: In four main studies, 1,874 adults with mild to moderate community-acquired pneumonia were treated for at least seven days with Factive or other antibiotics.
Estonian: Neljas põhiuuringus raviti kokku 1874 kerge või mõõduka keskkonnatekkelise pneumooniaga täiskasvanud patsienti vähemalt seitse päeva Factive või muu antibiootikumiga.
English: In three other main studies, 1,652 adults with acute exacerbation of chronic bronchitis were treated with Factive for five days or with other antibiotics.
Estonian: Kolmes muus põhiuuringus raviti kokku 1652 kroonilise bronhiidi ägenemisega täiskasvanud patsienti viis päeva Factive või muu antibiootikumiga.
English: The company informed the CHMP that there are no clinical trials or compassionate use programmes with Factive in Europe.
Estonian: Ettevõte teatas inimravimite komiteele, et Factive kliinilisi uuringuid ega ravimi eriloaga kasutamise programme Euroopas praegu ei toimu.
English: The effects of Factive were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Factive toimet muude katsetega.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Factive in the treatment of community-acquired pneumonia and acute exacerbation of chronic bronchitis caused by bacterial infection did not outweigh its risks.
Estonian: Inimravimite komitee oli tagasivõtmise ajal seepärast arvamusel, et Factive kasulikkus bakterinfektsioonist põhjustatud keskkonnatekkelise pneumoonia ning kroonilise bronhiidi ägenemise ravis ei ületa sellega kaasnevaid riske.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Factive could not have been approved for the treatment of community acquired pneumonia and acute exacerbation of chronic bronchitis caused by bacterial infection.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi komitee taotluse tagasivõtmise ajal põhjuseid ettevaatlikkuseks ning oli esialgsel seisukohal, et Factivele ei või anda bakterinfektsioonist põhjustatud keskkonnatekkelise pneumoonia ning kroonilise bronhiidi ägenemise ravis kasutamiseks müügiluba.
English: The Committee was also concerned there was not enough evidence of effectiveness of Factive in patients with moderate community-acquired pneumonia when given as a five-day treatment.
Estonian: Komitee arvates ei tõendanud uuringud piisavalt Factive efektiivsust, kui seda manustati keskkonnatekkelise pneumooniaga patsientide 5-päevase ravina.
English: What was Factive expected to be used for?
Estonian: Milleks kavatseti Factivet kasutada?
English: The disease is usually diagnosed in infants between one and five years of age.
Estonian: Haigus diagnoositakse tavaliselt 1-5-aastastel väikelastel.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Naglazyme to BioMarin Europe Limited on 24 January 2006.
Estonian: Euroopa Komisjon andis Naglazyme müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele BioMarin Europe Limited 24. jaanuaril 2006.
English: The main measure of effectiveness was how far the patients could walk after 24 weeks of treatment.
Estonian: Efektiivsuse põhinäitajaks oli vahemaa, mida patsiendid suutsid kõndida pärast 24-nädalast ravi.
English: This means that because the disease is rare, it has not been possible to obtain complete information about Naglazyme.
Estonian: Et see haigus esineb harva, ei ole olnud võimalik saada Naglazyme kohta täielikku teavet.
English: This causes the signs of the disease, the most noticeable being a short body, a large head and difficulty moving about.
Estonian: See põhjustab haigusnähte, millest kõige märgatavamad on lühike keha, suur pea ja liikumisraskused.
English: Naglazyme is given as a four-hour infusion once a week.
Estonian: Naglazymet manustatakse neljatunnise infusioonina üks kord nädalas.
English: This can improve the symptoms of MPS VI, including the ability of patients to move about.
Estonian: See võib leevendada MPS VI sümptomeid, sealhulgas patsientide võimet ringi liikuda.