FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) OASIS 5 was a double-blind, randomised, non-inferiority study with fondaparinux 2.5 mg subcutaneously once daily versus enoxaparin 1 mg/kg subcutaneously twice daily in approximately 20,000 patients with UA/NSTEMI.
Estonian: OASIS 5 oli topeltpime, randomiseeritud samaväärsuse uuring, kus võrreldi fondapariinuksi 2,5 mg nahaalusi üks kord päevas ja enoksapariini 1 mg/kg nahaalusi kaks korda päevas manustamist ligikaudu 20000 UA/NSTEMI patsiendil.
English: The incidences of adjudicated guiding catheter thrombus were 0.1% (1/1002) and 0.5% (5/1024), in patients randomised to “standard dose” and “low dose” UFH respectively during PCI.
Estonian: Juhtekateetri trombi esinemissagedus oli patsientidel, kes PCI ajal randomiseeriti fraktsioneerimata hepariini „standardannuse“ ja „madala annuse“ gruppi vastavalt 0,1% (1/1002) ja 0,5% (5/2014).
English: · bleeding disorders
Estonian: • vere kaaliumisisalduse vähenemine
English: • oozing from operation wound site
Estonian: • eritus operatsioonihaavast
English: Arixtra 7.5 mg/0.6 ml solution for injection, pre-filled syringe.
Estonian: Arixtra 7,5 mg/0,6 ml süstelahus, süstel.
English: Arixtra 10 mg/0.8 ml solution for injection, pre-filled syringe.
Estonian: Arixtra 10 mg/0,8 ml süstelahus, süstel.
English: Arixtra contains sodium
Estonian: Arixtra sisaldab naatriumi
English: Rare side effects
Estonian: Harvaesinevad kõrvaltoimed
English: Following once daily subcutaneous dosing, steady state of plasma levels is obtained after 3 to 4 days with a 1.3-fold increase in Cmax and AUC.
Estonian: Eakatel tervetel isikutel, on subkutaanse manustamise korral fondapariinuksi farmakokineetika lineaarne vahemikus 2…8 mg. Ükskord päevas manustamise järgselt, saabub tasakaalukontsentratsioon plasmas pärast 3…4 päeva koos 1,3-kordse Cmax ja AUC suurenemisega.
English: This dose may be reduced to 7.5 mg once a day if you have moderate kidney disease.
Estonian: Mõõduka neeruhaiguse korral võib seda annust vähendada 7,5 mg-ni üks kord päevas.
English: • syringe with orange plunger and a manual safety system.
Estonian: • oranži kolvi ja manuaalse turvasüsteemiga süstel.
English: Uncommon: chest pain
Estonian: Aeg-ajalt: valu rinnus
English: Haemorrhage
Estonian: Hemorraagia
English: Patients with Heparin Induced Thrombocytopenia
Estonian: Hepariinist indutseeritud trombotsütopeeniaga patsiendid
English: Paediatric patients - Fondaparinux has not been investigated in this population for the prevention of VTE or for the treatment of superficial vein thrombosis.
Estonian: Patsientide eripopulatsioonid Lapsed - Fondapariinuksit ei ole selles populatsioonis venoosse trombemboolia juhtude (VTE)
English: Treatment of superficial-vein thrombosis
Estonian: Kopsuarteri trombemboolia ravi
English: • Treatment of UA/NSTEMI and STEMI - Fondaparinux should not be used in patients with creatinine clearance < 20 ml/min (see section 4.3).
Estonian: • UA/NSTEMI ja STEMI ravi - Fondapariinuksit ei tohi kasutada patsientidel kreatiniini kliirensiga < 20 ml/min (vt lõik 4.3).
English: Common: post-operative haemorrhage, anaemia Uncommon: bleeding (epistaxis, gastrointestinal, haemoptysis, haematuria, haematoma) thrombocytopenia, purpura, thrombocythaemia, platelet abnormal, coagulation disorder
Estonian: Aeg-ajalt: verejooks (ninaverejooks, seedetrakti verejooks, veriköha, hematuuria, hematoom), trombotsütopeenia, purpur, trombotsüteemia, trombotsüütide häired, hüübimishäire
English: 1: Odds ratio: Low Dose/Standard Dose Note: MI - myocardial infarction.
Estonian: 1: Šansisuhe: Madal annus/Standardannus
English: • The active substance is 1.5 mg fondaparinux sodium in 0.3 ml solution for injection
Estonian: - Toimeaine on 1,5 mg naatriumfondapariinuksit 0,3 ml süstelahuses.
English: Read the package leaflet before use.
Estonian: Nahaaluseks manustamiseks Enne ravimi kasutamist lugege pakendi infolehte.
English: Each pre-filled syringe (0.3 ml) contains 1.5 mg of fondaparinux sodium.
Estonian: Üks süstel (0,3 ml) sisaldab 1,5 mg naatriumfondapariinuksit.
English: • syringe with violet plunger and a manual safety system.
Estonian: • violetse kolvi ja manuaalse turvasüsteemiga süstel.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.8 ml) contains 10 mg fondaparinux sodium.
Estonian: Üks süstel (0,8 ml) sisaldab 10 mg naatriumfondapariinuksit.
English: Arixtra 2.5 mg/0.5 ml solution for injection, pre-filled syringe.
Estonian: Arixtra 2,5 mg/0,5 ml süstelahus, süstel.
English: • diarrhoea or constipation
Estonian: • iiveldus või oksendamine
English: Each pre-filled syringe (0.5 ml) contains 2.5 mg of fondaparinux sodium.
Estonian: Üks süstel (0,5 ml) sisaldab 2,5 mg naatriumfondapariinuksit.
English: • internal bleeding in the brain, liver or abdomen
Estonian: • maksaverejooks, kolju- või kõhuõõnesisene verejooks
English: • Subcutaneous administration
Estonian: • Nahaalune manustamine
English: For prevention of VTE- Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Estonian: VTE profülaktika - Ravimeid, mis suurendavad hemorraagia tekkeriski, ei tohi VTE profülaktikaks fondapariinuksiga samaaegselt manustada.
English: • internal bleeding in the brain or abdomen
Estonian: • kolju- või kõhuõõnesisene verejooks
English: NAME OF THE MEDICINAL PRODUCT Arixtra 10 mg/0.8 ml solution for injection fondaparinux sodium
Estonian: Arixtra 10 mg/0,8 ml süstelahus naatriumfondapariinuks
English: Treatment of Pulmonary Embolism
Estonian: Naatriumkloriid Süstevesi
English: • indigestion
Estonian: • seedehäired
English: Prophylaxis of VTE - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min (see section 4.3).
Estonian: VTE profülaktika - Fondapariinuksit ei tohi kasutada patsientidel, kellel on kreatiniini kliirens < -20 ml/min (vt lõik 4.3).
English: BATCH NUMBER Lot
Estonian: Madal annus UFH
English: • prevent the formation of blood clots in the blood vessels of the legs or lungs after orthopaedic surgery (such as hip or knee surgery) or abdominal surgery
Estonian: Arixtra't kasutatakse: - verehüüvete tekke vältimiseks jala või kopsu veresoontes pärast ortopeedilisi operatsioone (nt puusaluu- või põlveoperatsiooni) või kõhuõõneoperatsiooni - verehüüvete tekke vältimiseks piiratud liikuvusega ägeda haiguse ajal ja selle järgselt.
English: Day 30 was significantly reduced from 15% for the control group to 12.1% for the fondaparinux group (hazard ratio 0.79, 95% CI, 0.65;0.97, p = 0.023).
Estonian: Patsientide seas, kellele esialgu reperfusiooni ei tehtud, vähenes surma/re-MI esinemissagedus 30. päeval oluliselt 15%-lt kontrollrühmas 12,1%-ni fondapariinuksi rühmas (riskimäär 0,79, 95% CI, 0,65;0,97, p = 0,023).
English: Arixtra 5 mg/0.4 ml solution for injection, pre-filled syringe.
Estonian: Arixtra 5 mg/0,4 ml süstelahus, süstel.
English: Arixtra 1.5 mg/0.3 ml solution for injection, pre-filled syringe.
Estonian: Arixtra 1,5 mg/0,3 ml süstelahus, süstel.
English: • if you are 75 years old or older
Estonian: - kui teil on raske maksahaigus - kui teil on neeruhaigus - kui te olete 75-aastane või eakam - kui te kaalute vähem kui 50 kg
English: • syringe with yellow plunger and a manual safety system.
Estonian: • fuksiinpunase kolvi ja manuaalse turvasüsteemiga süstel.
English: • syringe with blue plunger and a manual safety system.
Estonian: • sinise kolvi ja manuaalse turvasüsteemiga süstel.
English: NAME OF THE MEDICINAL PRODUCT Arixtra 1.5 mg/0.3 ml solution for injection fondaparinux sodium
Estonian: Arixtra 1,5 mg/0,3 ml süstelahus naatriumfondapariinuks
English: Fondaparinux should be used with caution in patients with a history of HIT.
Estonian: HIT anamneesiga patsientidel peab fondapariinuksit kasutama ettevaatusega.
English: Do not inject a double dose to make up for a forgotten dose.
Estonian: Ärge süstige kahekordset annust, kui annus jäi eelmisel korral manustamata.
English: EU/1/02/206/024 - 2 pre-filled syringes with a manual safety system EU/1/02/206/025 - 10 pre-filled syringes with a manual safety system EU/1/02/206/026 - 20 pre-filled syringes with a manual safety system
Estonian: EU/1/02/206/024 - 2 manuaalse turvasüsteemiga süstelit EU/1/02/206/025 - 10 manuaalse turvasüsteemiga süstelit EU/1/02/206/026 - 20 manuaalse turvasüsteemiga süstelit
English: NAME OF THE MEDICINAL PRODUCT Arixtra 7.5 mg/0.6 ml solution for injection fondaparinux sodium
Estonian: Arixtra 7,5 mg/0,6 ml süstelahus naatriumfondapariinuks
English: • low number of platelets (blood cells necessary for blood clotting)
Estonian: • trombotsüütide ehk vereliistakute (verehüübimises osalevad rakud) arvu langus
English: Uncommon: nausea, vomiting
Estonian: Harv: düspnoe, köha
English: • syringe with a yellow plunger and an automatic safety system
Estonian: • fuksiinpunase kolvi ja automaatse turvasüsteemiga süstel
English: Sodium chloride Water for injections Hydrochloric acid Sodium hydroxide
Estonian: Vesinikkloriidhape Naatriumhüdroksiid
English: • rash
Estonian: • tursed
English: In clinical studies performed with fondaparinux, oral anticoagulants (warfarin) did not interact with the pharmacokinetics of fondaparinux; at the 10 mg dose used in the interaction studies, fondaparinux did not influence the anticoagulation monitoring (INR) activity of warfarin.
Estonian: Fondapariinuksiga läbiviidud kliinilistes uuringutes, suukaudsed antikoagulandid (varfariin) ei avaldanud fondapariinuksiga farmakokineetilist koostoimet.
English: • high number of platelets (blood cells necessary for blood clotting)
Estonian: • trombotsüütide ehk vereliistakute (verehüübimises osalevad rakud) arvu suurenemine
English: · stomach ulcer
Estonian: • kõhuvalu
English: NAME OF THE MEDICINAL PRODUCT Arixtra 2.5 mg/0.5 ml solution for injection fondaparinux sodium
Estonian: Arixtra 2,5 mg/0,5 ml süstelahus naatriumfondapariinuks
English: EU/1/02/206/027 - 2 pre-filled syringes with a manual safety system EU/1/02/206/028 - 10 pre-filled syringes with a manual safety system EU/1/02/206/033 - 20 pre-filled syringes with a manual safety system
Estonian: EU/1/02/206/027 - 2 manuaalse turvasüsteemiga süstelit EU/1/02/206/028 - 10 manuaalse turvasüsteemiga süstelit EU/1/02/206/033 - 20 manuaalse turvasüsteemiga süstelit
English: Treatment of superficial-vein thrombosis - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min (see section 4.3).
Estonian: Pindmiste veenide tromboosi ravi - Fondapariinuksit ei tohi manustada patsientidele kreatiniini kliirensiga <20 ml/min (vt lõik 4.3).
English: Rare: chest pain, fatigue, hot flushes, leg pain, oedema genital, flushing, syncope
Estonian: Aeg-ajalt: tursed, perifeersed tursed, palavik, eritus haavast Harv: valu rinnus, väsimus, kuumahood, jalavalu, genitaalide turse, nahapunetus, minestus
English: EU/1/02/206/031 - 2 pre-filled syringes with a manual safety system EU/1/02/206/032 - 10 pre-filled syringes with a manual safety system EU/1/02/206/035 - 20 pre-filled syringes with a manual safety system
Estonian: EU/1/02/206/031 - 2 manuaalse turvasüsteemiga süstelit EU/1/02/206/032 - 10 manuaalse turvasüsteemiga süstelit EU/1/02/206/035 - 20 manuaalse turvasüsteemiga süstelit
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.6 ml) contains 7.5 mg fondaparinux sodium.
Estonian: Üks süstel (0,6 ml) sisaldab 7,5 mg naatriumfondapariinuksit.
English: Arixtra 7.5 mg/0.6 ml solution for injection Arixtra 10 mg/0.8 ml solution for injection fondaparinux sodium
Estonian: Pakendi infoleht: teave kasutajale Arixtra 5 mg/0,4 ml süstelahus Arixtra 7,5 mg/0,6 ml süstelahus Arixtra 10 mg/0,8 ml süstelahus naatriumfondapariinuks
English: EU/1/02/206/005- 2 pre-filled syringes with an automatic safety system EU/1/02/206/006 - 7 pre-filled syringes with an automatic safety system EU/1/02/206/007 - 10 pre-filled syringes with an automatic safety system EU/1/02/206/008 - 20 pre-filled syringes with an automatic safety system
Estonian: EU/1/02/206/005 - 2 automaatse turvasüsteemiga süstelit EU/1/02/206/006 - 7 automaatse turvasüsteemiga süstelit EU/1/02/206/007 - 10 automaatse turvasüsteemiga süstelit EU/1/02/206/008 - 20 automaatse turvasüsteemiga süstelit
English: NAME OF THE MEDICINAL PRODUCT Arixtra 5 mg/0.4 ml solution for injection fondaparinux sodium
Estonian: Arixtra 5 mg/0,4 ml süstelahus naatriumfondapariinuks
English: EU/1/02/206/015 - 2 pre-filled syringes with an automatic safety system EU/1/02/206/016 - 7 pre-filled syringes with an automatic safety system EU/1/02/206/017 - 10 pre-filled syringes with an automatic safety system EU/1/02/206/020 - 20 pre-filled syringe with an automatic safety system
Estonian: EU/1/02/206/015 - 2 automaatse turvasüsteemiga süstelit EU/1/02/206/016 - 7 automaatse turvasüsteemiga süstelit EU/1/02/206/017 - 10 automaatse turvasüsteemiga süstelit EU/1/02/206/020 - 20 automaatse turvasüsteemiga süstelit
English: EU/1/02/206/012- 2 pre-filled syringes with an automatic safety system EU/1/02/206/013 - 7 pre-filled syringes with an automatic safety system EU/1/02/206/014 - 10 pre-filled syringes with an automatic safety system EU/1/02/206/019 - 20 pre-filled syringe with an automatic safety system
Estonian: EU/1/02/206/012 - 2 automaatse turvasüsteemiga süstelit EU/1/02/206/013 - 7 automaatse turvasüsteemiga süstelit EU/1/02/206/014 - 10 automaatse turvasüsteemiga süstelit EU/1/02/206/019 - 20 automaatse turvasüsteemiga süstelit
English: Incidences of bleeding events in patients receiving the recommended regimen in the treatment of DVT or PE and aged <65 years, 65-75 and >75 years were 3.0 %, 4.5 % and 6.5 %, respectively.
Estonian: Veritsuste sagedus Arixtra´t soovitatud annustes SVT ja PE raviks saanud < 65a., 65...75a.
English: EU/1/02/206/001 - 2 pre-filled syringes with an automatic safety system EU/1/02/206/002 - 7 pre-filled syringes with an automatic safety system EU/1/02/206/003 - 10 pre-filled syringes with an automatic safety system EU/1/02/206/004 - 20 pre-filled syringes with an automatic safety system
Estonian: EU/1/02/206/001 - 2 automaatse turvasüsteemiga süstelit EU/1/02/206/002 - 7 automaatse turvasüsteemiga süstelit EU/1/02/206/003 - 10 automaatse turvasüsteemiga süstelit EU/1/02/206/004 - 20 automaatse turvasüsteemiga süstelit
English: EU/1/02/206/021 - 2 pre-filled syringes with a manual safety system EU/1/02/206/022 - 10 pre-filled syringes with a manual safety system EU/1/02/206/023 - 20 pre-filled syringes with a manual safety system
Estonian: EU/1/02/206/021 - 2 manuaalse turvasüsteemiga süstelit EU/1/02/206/022 - 10 manuaalse turvasüsteemiga süstelit EU/1/02/206/023 - 20 manuaalse turvasüsteemiga süstelit
English: • Treatment of superficial-vein thrombosis - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min (see section 4.3).
Estonian: • Pindmiste veenide tromboosi ravi - Fondapariinuksit ei tohi manustada patsientidele kreatiniini kliirensiga <20 ml/min (vt lõik 4.3).
English: EU/1/02/206/009- 2 pre-filled syringes with an automatic safety system EU/1/02/206//010 - 7 pre-filled syringes with an automatic safety system EU/1/02/206/011 - 10 pre-filled syringes with an automatic safety system EU/1/02/206/018 - 20 pre-filled syringe with an automatic safety system
Estonian: EU/1/02/206/009 - 2 automaatse turvasüsteemiga süstelit EU/1/02/206/010 - 7 automaatse turvasüsteemiga süstelit EU/1/02/206/011 - 10 automaatse turvasüsteemiga süstelit EU/1/02/206/018 - 20 automaatse turvasüsteemiga süstelit
English: EU/1/02/206/029 - 2 pre-filled syringes with a manual safety system EU/1/02/206/030 - 10 pre-filled syringes with a manual safety system EU/1/02/206/034 - 20 pre-filled syringes with a manual safety system
Estonian: EU/1/02/206/029 - 2 manuaalse turvasüsteemiga süstelit EU/1/02/206/030 - 10 manuaalse turvasüsteemiga süstelit EU/1/02/206/034 - 20 manuaalse turvasüsteemiga süstelit
English: • Prevention of VTE - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min (see section 4.3).
Estonian: • VTE profülaktika - Fondapariinuksit ei tohi kasutada patsientidel, kellel on kreatiniini kliirens < 20 ml/min (vt lõik 4.3).
English: SN:
Estonian: PC: SN: NN:
English: • pain
Estonian: • valu
English: • If you get any side effects, talk to your doctor or pharmacist.
Estonian: - Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti või apteekriga.
English: • if you have a risk of uncontrolled bleeding (haemorrhage) including: · stomach ulcer · bleeding disorders · recent bleeding into the brain (intracranial bleeding) · recent surgery on the brain, spine or eye
Estonian: - hiljutine koljusisene (intrakraniaalne) verejooks - hiljutine aju-, seljaaju- või silmaoperatsioon
English: Hepatic impairment - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
Estonian: Maksafunktsiooni häire VTE profülaktika - Kerge või mõõduka maksakahjustusega patsientidel ei ole annuse kohandamine vajalik.
English: Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopaenia.
Estonian: Tavaliselt ei reageeri fondapariinuks ristuvalt hepariini poolt indutseeritud trombotsütopeenia (HIT) haigete vereseerumiga.
English: • breathlessness
Estonian: • nahapunetus
English: Low body weight
Estonian: Väike kehakaal
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.4 ml) contains 5 mg fondaparinux sodium.
Estonian: Üks süstel (0,4 ml) sisaldab 5 mg naatriumfondapariinuksit.
English: Paediatric patients - Fondaparinux has not been investigated in this population for the prevention of VTE or for the treatment of superficial vein thrombosis or acute coronary syndrome (ACS).
Estonian: ärahoidmiseks või jalgade pindmiste veenide tromboosi või ägeda koronaarsündroomi raviks uuritud.
English: Aspen Pharma Trading Limited Tlf: 80010093/+44 (0)1423 852 995 aspenmedinfo@professionalinformation.co.uk
Estonian: Aspen Pharma Trading Limited Tel: 0039 0687502429 aspenmedinfo@professionalinformation.co.uk
English: 6.3 Shelf life
Estonian: Standardannus UFH
English: Aspen Pharma Trading Limited Tel.: 008001211566/+44 (0)1423 852 859 aspenmedinfo@professionalinformation.co.uk
Estonian: Aspen Pharma Trading Limited Tél/Tel: 0035 227861279 aspenmedinfo@professionalinformation.co.uk
English: In subjects undergoing PCI the incidence of adjudicated guiding catheter thrombus was 1.0% vs. 0.3% in fondaparinux vs. enoxaparin subjects, respectively.
Estonian: Patsientidel, kellel tehti PCI, oli juhtekateetri trombi esinemissagedus fondapariinuksi ja enoksapariini kasutamisel vastavalt 0,1 % ja 0,3 %.
English: EXP
Estonian: segasus
English: Uncommon: headache Rare: dizziness
Estonian: Aeg-ajalt: düspnoe
English: Rare: dyspnoea, coughing
Estonian: vertiigo, pearinglus, peavalu,
English: Aspen Pharma Trading Limited Τηλ: 80096374/+44 (0)1423 852 990 aspenmedinfo@professionalinformation.co.uk
Estonian: Aspen Pharma Trading Limited Tel: 00356 21497982 aspenmedinfo@professionalinformation.co.uk
English: What Arixtra looks like and contents of the pack Arixtra is a clear and colourless solution for injection.
Estonian: Kuidas Arixtra välja näeb ja pakendi sisu
English: What did the company present to support its application?
Estonian: Mis andmed esitas ettevõte oma taotluse toetuseks?
English: EMA/CHMP/896315/2011 EMEA/H/C/002140
Estonian: 17. november 2011 EMA/907378/2011 EMEA/H/C/002140
English: The applicant requested a re-examination of the negative opinion.
Estonian: Müügiloa taotleja taotles negatiivse arvamuse taasläbivaatamist.
English: The CHMP therefore confirmed its initial negative opinion.
Estonian: Sel põhjusel kinnitas inimravimite komitee oma esialgset negatiivset arvamust.
English: The CHMP felt that the measures proposed by the company to reduce these risks were insufficient.
Estonian: Inimravimite komitee leidis, et ettevõtte pakutud meetmed nende riskide vähendamiseks ei ole piisavad.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 17 November 2011.
Estonian: Pärast taotluse põhjenduste kaalumist vaatas komitee oma algse arvamuse uuesti läbi ja kinnitas 17. novembril 2011 soovitust müügiloa andmisest keelduda.
English: It was to be available as 50 mg tablets.
Estonian: Ravimit kavatseti turustada 50 mg tablettidena.
English: During the re-examination in November 2011, the CHMP's main concerns were not resolved.
Estonian: Arvamuse taasläbivaatamisel 2011. aasta novembris ei olnud inimravimite komitee leitud peamised probleemid lahenenud.
English: What is Sumatriptan Galpharm?
Estonian: Mis on Sumatriptan Galpharm?
English: The additional measures proposed by the company were still considered insufficient.
Estonian: Ka ettevõtte pakutud lisameetmed ei olnud inimravimite komitee arvates piisavad.
English: The company that applied for authorisation is Galpharm Healthcare Ltd.
Estonian: Müügiluba taotles ettevõte Galpharm Healthcare Ltd.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Sumatriptan Galpharm did not outweigh its risks and recommended that it be refused marketing authorisation.
Estonian: Seetõttu oli inimravimite komitee sel ajal arvamusel, et Sumatriptan Galpharmi kasulikkus ei ole suurem kui kaasnevad riskid, ning soovitas müügiloa andmisest keelduda.
English: This leads to a widening of blood vessels in the brain which can lead to a migraine attack.
Estonian: See põhjustab aju veresoonte laienemist, mis võib tekitada migreeniepisoode.
English: Migraine attacks occur when the level of 5hydroxytryptamine in the brain becomes low.
Estonian: Migreeniepisoodid tekivad, kui 5-hüdroksütrüptamiini sisaldus ajus on väike.
English: Neurotransmitters are chemicals
Estonian: Neurotransmitterid on keemilised ained, mis vahendavad närvirakkude vahelisi
English: On 21 July 2011, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Sumatriptan Galpharm, intended for the relief of migraine attacks in people who have been diagnosed with migraine.
Estonian: 21. juulil 2011 võttis inimravimite komitee vastu negatiivse arvamuse, soovitades keelduda andmast müügiluba ravimile Sumatriptan Galpharm, mida kavatseti kasutada migreeniepisoodide leevendamiseks inimestel, kellel on diagnoositud migreen.
English: The active substance in Sumatriptan Galpharm and Imigran, sumatriptan, works by mimicking the action of the neurotransmitter 5-hydroxytryptamine (serotonin) in the brain.
Estonian: Sumatriptan Galpharmi ja Imigrani toimeaine sumatriptaan jäljendab ajus neurotransmitteri 5-hüdroksütrüptamiini (serotoniini) toimet.
English: Sumatriptan Galpharm is a medicine that contains the active substance sumatriptan.
Estonian: Sumatriptan Galpharm on ravim, mis sisaldab toimeainena sumatriptaani.
English: Refusal of the marketing authorisation for Sumatriptan Galpharm 50 mg tablets EMA/CHMP/896315/2011
Estonian: Sumatriptan Galpharm 50 mg tablettide müügiloa andmisest keeldumine EMA/159002/20121
English: The CHMP also remained concerned about the safety of Sumatriptan Galpharm, in particular the potential for misuse and overuse as well as the risk of misdiagnosis of migraine and lack of medical follow-up when used in the non-prescription setting.
Estonian: Inimravimite komitee arvates oli endiselt probleem Sumatriptan Galpharmi ohutus, eelkõige ravimi võimalik väär- ja liigkasutamine, samuti migreeni väärdiagnoosimise risk ning meditsiinilise järelevalve puudumine ravimi kasutamisel käsimüügiravimina.
English: In addition the CHMP felt that Sumatriptan Galpharm in the non-prescription setting is not appropriate because migraine as a condition changes over time as well as the patient's cardiovascular and cerebrovascular status, and monitoring is therefore essential.
Estonian: Peale selle leidis inimravimite komitee, et Sumatriptan Galpharmi kasutamine käsimüügiravimina ei ole kohane seetõttu, et migreen kui terviseseisund muutub aja jooksul nagu ka patsiendi aju- ja südameveresoonkonna seisund, mille tõttu on hädavajalik pidevalt jälgida patsienti.