FrancophonIA/ELRC3.0 huggingface dataset:
English: Each vial contains 5 mg of etelcalcetide (as hydrochloride) in 1 mL of solution.
Estonian: Üks viaal sisaldab 5 mg etelkaltsetiidi (vesinikkloriidina) 1 ml lahuses.
English: Each vial contains 10 mg of etelcalcetide (as hydrochloride) in 2 mL of solution.
Estonian: Üks viaal sisaldab 10 mg etelkaltsetiidi (vesinikkloriidina) 2 ml lahuses.
English: Each vial contains 2 mL solution for injection.
Estonian: Üks viaal sisaldab 2 ml süstelahust.
English: Each vial contains 1 mL solution for injection.
Estonian: Üks viaal sisaldab 1 ml süstelahust.
English: convulsions and stress-related findings were observed at clinical exposure levels.
Estonian: Kliinilise süsteemse saadavuse taseme korral täheldati seoses kaltsiumisisalduse langusega treemorit, tõmblusi ja stressiilminguid.
English: Parsabiv 5 mg solution for injection
Estonian: Parsabiv 5 mg süstelahus
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 10 mg of etelcalcetide (as hydrochloride).
Estonian: TOIMEAINE(TE) SISALDUS Üks viaal sisaldab 10 mg etelkaltsetiidi (vesinikkloriidina).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 2.5 mg of etelcalcetide (as hydrochloride).
Estonian: TOIMEAINE(TE) SISALDUS Üks viaal sisaldab 2,5 mg etelkaltsetiidi (vesinikkloriidina).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 5 mg of etelcalcetide (as hydrochloride).
Estonian: TOIMEAINE(TE) SISALDUS Üks viaal sisaldab 5 mg etelkaltsetiidi (vesinikkloriidina).
English: There were no effects on embryo-foetal development in rats and rabbits when exposed to up to 1.8 to 4.3 times clinical exposure levels during organogenesis.
Estonian: Kliinilist taset 1,8 kuni 4,3 korda ületav süsteemne saadavus organogeneesi perioodil ei mõjutanud rottide ja küülikute embrüonaalset ja lootearengut.
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 2.5 mg solution for injection etelcalcetide
Estonian: RAVIMPREPARAADI NIMETUS Parsabiv 2,5 mg süstelahus etelkaltsetiid
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 10 mg solution for injection etelcalcetide
Estonian: RAVIMPREPARAADI NIMETUS Parsabiv 10 mg süstelahus etelkaltsetiid
English: • High potassium levels in blood
Estonian: • Vere kõrge kaaliumisisaldus
English: Adynamic bone may develop if PTH levels are chronically suppressed below 100 pg/mL.
Estonian: PTH taseme kestval supressioonil allapoole 100 pg/ml võib tekkida adünaamiline luuhaigus.
English: No specific pharmacokinetic studies of etelcalcetide have been conducted in patients with mild to severe kidney impairment.
Estonian: Kerge ja mõõduka neerukahjustusega patsientidel ei ole etelkaltsetiidi farmakokineetikat spetsiaalselt uuritud.
English: It is unknown whether etelcalcetide is present in human milk.
Estonian: Ei ole teada, kas etelkaltsetiid eritub inimese rinnapiima.
English: The threshold for seizures may be lowered by significant reductions in serum calcium levels.
Estonian: Seerumi kaltsiumisisalduse oluline langus võib langetada krambiläve.
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 5 mg solution for injection etelcalcetide
Estonian: RAVIMPREPARAADI NIMETUS Parsabiv 5 mg süstelahus etelkaltsetiid
English: Decreased myocardial performance, hypotension, and congestive heart failure (CHF) may be associated with significant reductions in serum calcium levels.
Estonian: Seerumi kaltsiumisisalduse olulise langusega võib kaasneda südamelihase sooritusvõime langus, hüpotensioon ja südame paispuudulikkus.
English: Reduction in PTH levels correlated with plasma etelcalcetide concentrations in haemodialysis patients.
Estonian: Hemodialüüsi saavatel patsientidel oli PTH taseme langus vastavuses etelkaltsetiidi kontsentratsiooniga.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Parsabiv 5 mg solution for injection etelcalcetide
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Parsabiv 5 mg süstelahus etelkaltsetiid i.v.
English: Parsabiv is a solution for injection in a vial.
Estonian: Parsabiv on süstelahus viaalis.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Parsabiv 2.5 mg solution for injection etelcalcetide
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Parsabiv 2,5 mg süstelahus etelkaltsetiid i.v.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Parsabiv 10 mg solution for injection etelcalcetide
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Parsabiv 10 mg süstelahus etelkaltsetiid i.v.
English: Serum calcium levels should be closely monitored in patients with a history of a convulsion disorder while being treated with Parsabiv.
Estonian: Parsabiv'iga ravitavatel, varasemate krambihäiretega patsientidel peab hoolikalt jälgima seerumi kaltsiumisisaldust.
English: *PFU: plaque forming units
Estonian: *PFU= lüüsilaike moodustavad ühikud
English: Member State (EU/EEA)
Estonian: Liikmesriik (EL/EMP)
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Estonian: I lisa Nimekiri ravimi nimetustest, ravimvormidest, tugevusest, manustamisviisidest ja müügiloa hoidjatest liikmesriikides
English: 1087 Lefkosia Cyprus
Estonian: 4th Floor 1087 Lefkosia Cyprus
English: United Kingdom Sanofi Pasteur MSD Limited Mallards Reach
Estonian: Suurbritannia Sanofi Pasteur MSD Limited Mallards Reach
English: Kifissias Avenue 266 Halandri 15232, Athens Greece
Estonian: Kifissias Avenue 266 Halandri 15232, Athens
English: GlaxoSmithKline (Cyprus) Ltd 12-14 Kennedy Avenue Kennedy Business Centre
Estonian: GlaxoSmithKline (Cyprus) Ltd 12-14 Kennedy Avenue
English: 8, Rue Jonas Salk FR-69007 Lyon France
Estonian: 8, Rue Jonas Salk FR-69007 Lyon
English: 2031 BN Haarlem
Estonian: 2031 BN Haarlem The Netherlands
English: Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-Roi Cedex France
Estonian: Prantsusmaa Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-Roi Cedex France
English: Bruņinieku iela 5 Rīga LV-1001
Estonian: GlaxoSmithKline Latvia SIA Bruņinieku iela 5 Rīga LV-1001 Latvia
English: Sanofi Pasteur S.A. 2 avenue Pont Pasteur 69007 Lyon France
Estonian: Prantsusmaa Sanofi Pasteur S.A. 2 avenue Pont Pasteur 69007 Lyon
English: United Kingdom SmithKline Beecham plc 980 Great West Road Brentford
Estonian: Suurbritannia SmithKline Beecham plc 980 Great West Road Brentford
English: Sanofi Pasteur MSD S.N.C.,
Estonian: Prantsusmaa Sanofi Pasteur MSD S.N.C.,
English: Slovak Republic Merck Sharp & Dohme B.V Waarderweg 39
Estonian: Merck Sharp & Dohme B.V Waarderweg 39
English: The Netherlands GlaxoSmithKline B.V Huis ter Heideweg 62
Estonian: Madalmaad GlaxoSmithKline B.V Huis ter Heideweg 62
English: Merck Sharp & Dohme B.V. Waardeweg 39, 2031 BN Haarlem The Netherlands
Estonian: Waardeweg 39, 2031 BN Haarlem The Netherlands
English: Merck Sharp & Dohme OÜ A.H. Tammsaare tee 47 Tallinn 11316
Estonian: Tammsaare tee 47 Tallinn 11316
English: PRIORIX TETRA one dose (0.5 ml) contains:
Estonian: PRIORIX TETRA üks annus (0,5 ml) sisaldab:
English: Measles virus Edmonston 749D strain (live, attenuated) - 10
Estonian: Leetrite viirus Edmonston 749D tüvi (elus, nõrgestatud) - 103.0 CCID50
English: Subcutaneous use Intramuscular use, subcutaneous use
Estonian: Subkutaanne Intramuskulaarne, subkutaanne
English: Live attenuated mumps virus (RIT 4385
Estonian: Elus, nõrgestatud mumpsi viirus (RIT 4385
English: Sanofi Pasteur MSD Avenue Jules Bordetlaan 13 B-1140 Brussels Belgium
Estonian: Sanofi Pasteur MSD Avenue Jules Bordetlaan 13 B-1140 Brussels belgia
English: Live attenuated mumps virus (RIT 4385,
Estonian: elus, nõrgestatud mumpsi viirus (RIT 4385
English: GlaxoSmithKline 100 route de Versailles 78163 Marly-le-Roi Cedex
Estonian: 78163 Marly-le-Roi Cedex
English: Mumps virus Jeryl Lynn strain (live, attenuated) - 5 x 10
Estonian: Mumpsi viirus Jeryl Lynn tüvi (elus, nõrgestatud) - 5 x 103.0 CCID50
English: Varivax one dose (0.5 ml) contains: not less than 1350 PFU* of the live attenuated varicella virus (OKA.Merck strain)
Estonian: Varivax üks annus (0,5ml) sisaldab: mitte vähem kui 1350 PFU* varicella viirus (OKA.Merck tüvi)
English: Varicella virus (Oka/Merck): not less than 1350 PFU*
Estonian: Varicella viirus (Oka/Merck) - mitte vähem kui: 1350 PFU*
English: Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103.0 CCID50 Live attenuated varicella virus (Oka strain)not less than 103.3 PFU*
Estonian: Elus nõrgestatud punetiste viirus (Wistar RA 27/3 tüvi) - mitte vähem kui 103.0 CCID50 Elus nõrgestatud varicella viirus - mitte vähem kui 103,3 PFU*
English: CCID50 of the measles virus Enders-Edmonston strain, not less than 12500 CCID50 of the mumps virus (Jeryl Lynn strain); and not less than 10 CCID50of the Wistar RA 27/3 rubella virus strains
Estonian: 12500 CCID50 mumpsi viirust (Jeryl Lynn tüvi); ja mitte vähem kui 103.0 CCID50 Wistar RA
English: Priorix-Tetra one dose (0.5 ml) contains dose:
Estonian: Priorix-Tetra lag üks annus (0,5 ml) sisaldab:
English: Rudixax one dose (0.5 ml) contains: live, attenuated rubella virus (strain Wistar RA 27/3) - at least 10
Estonian: Rudixax üks annus (0,5 ml) sisaldab elus, nõrgestatud punetiste viirus (tüvi Wistar RA 27/3) - vähemalt 103.0 CCID50
English: Na Pankráci 17/1685
Estonian: Na Pankráci 17/1685 140 21 Prague 4 Czech Republic
English: Varivax one dose (0.5 ml) contains: varicella virus (zoster vivo) - 1350 PFU*
Estonian: Varivax üks annus (0,5 ml) sisaldab: varicella viirus(zoster vivo) - 1350 FPU*
English: one dose (0.5 ml) contains: Rubella virus live attenuated (Strain Wistar RA 27/3M) - not less than 10 TCID50
Estonian: üks annus (0,5 ml) sisaldab: Punetiste viirus elus nõrgestatud (tüvi Wistar RA 27/3M) - mitte vähem kui 103.0 TCID50
English: Varicella Virus OKA/Merck Strain - not less than 1350 PFU*
Estonian: Varicella viirus OKA/Merck tüvi - mitte vähem kui 1350 PFU*
English: Mumps virus URABE AM-9 strain (live, attenuated) not less than 5 x 10
Estonian: Mumpsi viirus URABE AM-9 tüvi (elus, nõrgestatud) mitte vähem kui 5 x 103.0 CCID50
English: Varilrix Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension one dose (0.5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103.3 PFU*
Estonian: Varilrix Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension üks annus (0,5 ml) sisaldab elus nõrgestatud varicella zoster viirust (Oka tüvi) - mitte vähem kui 103.3 PFU*
English: Luxembourg GlaxoSmithKline Biologicals S.A.
Estonian: Luksemburg GlaxoSmithKline Biologicals S.A.
English: one dose (0.5 ml) contains: not less than 103.0 CCID50 of the measles virus Enders-Edmonston strain not less than 5 x 103.0 CCID50 of the mumps virus (Jeryl Lynn strain) not less than 103.0 CCID50 of the rubella virus strain
Estonian: Enders-Edmonston tüvi mitte vähem kui 5 x 103.0 CCID50 mumpsi viirus (Jeryl Lynni tüvi) mitte vähem kui 103.0 CCID50 punetiste viirus tüvi
English: Czech Republic GlaxoSmithKline, s.r.o.
Estonian: GlaxoSmithKline, s.r.o.
English: VARIVAX Powder for Suspension one dose (0.5 ml) contains: Varicella Virus OKA/Merck Strain1350 PFU*
Estonian: VARIVAX Powder for Suspension üks annus (0,5 ml) sisaldab: Varicella viirus OKA/Merck tüvi - 1350 PFU*
English: one dose (0.5 ml) contains: Mumps virus (Strain Jeryl Lynn - B level) - not less than 20 x 10 TCID50
Estonian: Mumpsi viirus (Jeryl Lynn tüvi - B tase)mitte vähem kui 20 x 103.0 TCID50
English: Measles virus Schwartz strain (live, attenuated) - not less than 10
Estonian: Leetrite viirus (elus, nõrgestatud) - mitte vähem kui 10
English: vaccin à virus vivants atténués contre la rougeole et la rubéole one dose (0.5 ml) contains: Measles virus Schwartz strain (live, attenuated) - not less than 10
Estonian: vaccin à virus vivants atténués contre la rougeole et la rubéole üks annus (0,5 ml) sisaldab: leetrite viirus Schwartzi tüvi (elus, nõrgestatud) - mitte vähem kui 103.0 CCID50
English: Live attenuated varicella virus (OKA strain) - not less than 103.3 PFU*
Estonian: Elus, nõrgestatud Varicella viirus (Oka strain) - mitte vähem kui 103.3 PFU*
English: Varivax one dose (0.5 ml) contains: Varicella virus (Oka/Merck strain) ≥ 1350 PFU*
Estonian: Varivax üks annus (0,5 ml) sisaldab: Varicella viirus (Oka/Merck tüvi) - ≥1350 PFU*
English: one dose (0.5 ml) contains: Live, attenuated Varicella virus (OKA/Merck strain) not less than 1350 PFU*
Estonian: üks annus (0,5 ml) sisaldab: elus, nõrgestatud Varicella viirus (OKA/Merck tüvi), mitte vähem kui 1350 PFU*
English: Live attenuated measles virus (Schwarz strain) -not less than 103.0 CCID50
Estonian: Elus, nõrgstatud leetrite viirus (Schwarzi tüvi) - mitte vähem kui 103.0 CCID50
English: Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 104.4 CCID50
Estonian: Elus nõrgestatud mumpsi viirus (RIT 4385 tüvi, tuletatud Jeryl Lynni tüvest) - mitte vähem kui 104,4 CCID50
English: Varicella virus OKA/Merck strain (live, attenuated) not less than 1350 PFU*
Estonian: Varicella viirus (tüvi Oka/Merck) (elus, nõrgestatud) - mitte vähem kui 1350.00 PFU*
English: Mumps vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Estonian: Euroopa Liidu müügiloaga mumpsi (elus)vaktsiinid Liikmesriik (EL/EMP)
English: Vaccin varicelleux vivant one dose (0.5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103.7 PFU*
Estonian: Vaccin varicelleux vivant üks annus (0,5 ml) sisaldab: elus, nõrgestatud varicella-zoster viirus (Oka tüvi) - mitte vähem kui 103,7 PFU*
English: Aventis Pasteur MSD S.A. Pº Castellana, 141 28046 Madrid Spain
Estonian: Hispaania Aventis Pasteur MSD S.A. Pº Castellana, 141
English: RUBEATEN BERNA Rubella virus live (Strain Wistar RA 27/3) - not less than 10
Estonian: RUBEATEN BERNA Punetiste viirus elus (tüvi Wistar RA 27/3) - mitte vähem kui 103.0 TCID50
English: one dose (0.5 ml) contains: Live attenuated varicella virus (Oka/Merck strain) not less than 1350 PFU*
Estonian: üks annus (0,5 ml) annus sisaldab: elus nõrgestatud varicella viirus (Oka/Merck tüvi) mitte vähem kui 1350 PFU*
English: Varilrix powder and solvent for solution for injection one dose (0.5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103.3 PFU*
Estonian: VARILRIX powder and solvent for solution for injection üks annus (0,5 ml) sisaldab: elus, nõrgestatud varicella-zoster viirus (Oka tüvi) 10 3.3 PFU*
English: Measles, mumps and rubella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Estonian: Euroopa Liidu müügiloaga leetrite, mumpsi ja punetiste (elus)vaktsiinid Liikmesriik (EL/EMP)
English: Measles, mumps, rubella and varicella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Estonian: Euroopa Liidu müügiloaga leetrite, mumpsi, punetiste ja tuulerõugete (elus)vaktsiinid Liikmesriik (EL/EMP)
English: Varicella, live attenuated (Oka/Merck strain) - 1350 PFU*
Estonian: Varicella, elus, nõrgestatud (Oka/Merck tüvi)1350 PFU*
English: United Kingdom SmithKline Beecham plc 980 Great West Road
Estonian: Suurbritannia SmithKline Beecham plc
English: strain, derived from Jeryl Lynn strain)not less than 103.7 CCID50
Estonian: tüvi, tuletatud Jeryl Lynn tüvest) - mitte vähem kui 103.7 CCID50
English: OREILLONS AVENTIS PASTEUR MSD, poudre et solvant pour suspension injectable en seringue préremplie vaccin des oreillons, atténué
Estonian: OREILLONS AVENTIS PASTEUR MSD, poudre et solvant pour suspension injectable en seringue préremplie vaccin des oreillons, atténué üks annus (0,5 ml) sisaldab: mumpsi viirus - 5 x 103.0 CCID50
English: SmithKline Beecham plc 980 Great West Road Brentford
Estonian: 980 Great West Road Brentford
English: vaccin à virus vivants atténués contre les oreillons one dose (0.5 ml) contains: Mumps virus URABE AM-9 strain (live, attenuated) - not less than 5 x
Estonian: vaccin à virus vivants atténués contre les oreillons üks annus (0,5 ml) sisaldab: mumpsi viirus - mitte vähem kui 5 x 103.0 CCID50
English: PRIORIX-TETRA one dose (0.5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 10
Estonian: PRIORIX-TETRA üks annus (0,5 ml) sisaldab: Elus, nõrgestatud leetrite viirus, tüvi (Schwarzi tüvi) - mitte vähem kui 103.0 CCID50
English: Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103.0 CCID50
Estonian: elus, nõrgestatud punetiste viirus (Wistar RA 27/3 tüvi) - mitte vähem kui 103.0 CCID50
English: Varicella virus Oka/Merck strain (live, attenuated) ≥1350 PFU*
Estonian: Varicella viirus Oka/Merck tüvi (elus, nõrgestatud)≥1350 PFU*
English: derived from Jeryl Lynn strain) - not less than 104.4 CCID50
Estonian: tüvi, tuletatud Jeryl Lynni tüvest) - mitte vähem kui 104,4 CCID50
English: Rubella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Estonian: Euroopa Liidu müügiloaga punetiste (elus)vaktsiinid Liikmesriik (EL/EMP)
English: Varicella virus, strain Oka/Merck live attenuated - 1350 PFU*
Estonian: Varicella viirus, tüvi Oka/Merck, elus, nõrgestatud - 1350 PFU*
English: Varilrix one dose (0.5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103.3 PFU*
Estonian: Varilrix üks annus (0,5 ml) sisaldab: elus nõrgestatud varicella-zoster viirus (Oka tüvi) - mitte vähem kui 103.3 PFU*
English: Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain)not less than 10
Estonian: Elus nõrgestatud mumpsi viirus (tüvi RIT 4385, tuletatud Jeryl Lynn tüvest) - mitte vähem kui
English: Measles and rubella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Estonian: Euroopa Liidu müügiloaga leetrite ja punetiste (elus)vaktsiinid Liikmesriik (EL/EMP)
English: Rubella virus Wistar RA 27/3 strain (live, attenuated) - 10
Estonian: Punetiste viirus Wistar RA 27/3 tüvi (elus, nõrgestatud) - 103.0 CCID50
English: strain derived from Jeryl Lynn strain) - not less than 104.4 CCID50
Estonian: tüvi, tuletatud Jeryl Lynni tüvest) - mitte vähem kui 104.0 CCID50
English: Measles vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Estonian: Euroopa Liidu müügiloaga leetrite (elus)vaktsiinid Liikmesriik (EL/EMP)
English: one dose (0,5 ml) contains : Live attenuated varicella-zoster virus (Oka strain) - not less than 103.3 PFU*
Estonian: Üks annus (0,5 ml) sisaldab : elus nõrgestatud varicella-zoster viirus (Oka tüvi) - mitte vähem kui 103.3 PFU*
English: Varivax prasek in vehikel za suspenzijo za injiciranje one dose (0.5 ml) contains: Varicella virus (strain Oka/Merck) (live, attenuated) - not less than 1350.00 PFU*
Estonian: Varivax powder and solvent for suspension for injection üks annus (0,5 ml) sisaldab: Varicella viirus Oka/Merck tüvi (elus nõrgestatud) ≥1350 PFU*
English: Live attenuated varicella virus (Oka strain)not less than 103.3 PFU*
Estonian: Elus, nõrgestatud Varicella viirus (Oka tüvi) - mitte vähem kui 103.3 PFU*.
English: Rubella virus Wistar RA 27/3 strain (live, attenuated) - not less than 10
Estonian: Elus, nõrgestatud punetiste viirus (Wistar RA 27/3 strain) - mitte vähem kui 103.0
English: Varicella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Estonian: Euroopa Liidu müügiloaga tuulerõugete (elus)vaktsiinid Liikmesriik (EL/EMP)
English: What measures are being taken to ensure the safe and effective use of Granpidam?
Estonian: Mis meetmed võetakse, et tagada Granpidami ohutu ja efektiivne kasutamine?
English: The full EPAR for Granpidam can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Granpidami kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In this case Granpidam was not compared with the reference product Revatio, but with Viagra.
Estonian: Käesoleval juhul ei võrreldud Granpidami mitte võrdlusravimi Revatioga, vaid Viagraga.
English: This was considered acceptable since Revatio and Viagra have the same composition and are made in the same way by the same manufacturer.
Estonian: Seda peeti vastuvõetavaks, sest Revatiol ja Viagral on sama kvalitatiivne koostis ning neid toodab sama meetodiga sama tootja.
English: Granpidam is available as tablets (20 mg).
Estonian: Granpidami turustatakse tablettidena (20 mg).
English: What is Granpidam and what is it used for?
Estonian: Mis on Granpidam ja milleks seda kasutatakse?
English: Other information about Granpidam
Estonian: Muu teave Granpidami kohta
English: The Committee recommended that Granpidam be approved for use in the EU.
Estonian: Komitee soovitas Granpidami kasutamise Euroopa Liidus heaks kiita.
English: Granpidam sildenafil
Estonian: Granpidam sildenafiil
English: This enzyme is found in the blood vessels of the lungs.
Estonian: Seda ensüümi leidub kopsude veresoontes.
English: Why is Granpidam approved?
Estonian: Miks Granpidam heaks kiideti?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom dose would be 10 mg three times a day but Granpidam can only be used when a 20-mg dose is to be given.
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom patsient vajab 20 mg annust.
English: It is not intended to provide practical advice on how to use Granpidam.
Estonian: Hindamisaruandes ei anta Granpidami kasutamise praktilisi nõuandeid.
English: Because Granpidam is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Granpidam on geneeriline ravim, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Granpidam have been included in the summary of product characteristics and the package leaflet.
Estonian: Granpidami ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: The active substance in Granpidam, sildenafil, belongs to a group of medicines called ‘phosphodiesterase-type-5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme.
Estonian: Granpidami toimeaine sildenafiil kuulub fosfodiesteraas-5 (PDE5) inhibiitorite ravimirühma, st sildenafiil blokeerib ensüümi PDE5.
English: Because the effectiveness and safety of sildenafil in PAH is already well established, studies in people have been limited to tests to determine that it is bioequivalent to another authorised sildenafilcontaining tablet.
Estonian: Et sildenafiili efektiivsus ja ohutus pulmonaalse arteriaalse hüpertensiooni ravis on hästi tõendatud, piirdusid patsiendiuuringud katsetega, milles näidati Granpidami bioekvivalentsust teise heakskiidetud sildenafiili sisaldava tabletiga.
English: Therefore, the CHMP's view was that, as for Revatio, the benefit of Granpidam outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu ka Revatio korral, ületab Granpidami kasulikkus sellega kaasnevad riskid.
English: When it is blocked, a substance called ‘cyclic guanine monophosphate' (cGMP) cannot be broken down, so that it remains in the vessels where it causes relaxation and widening of the blood vessels.
Estonian: Kui ensüüm on blokeeritud, ei saa see lagundada tsüklilist guanosiinmonofosfaati (cGMP), mis jääb veresoontesse, põhjustades nende lõdvestumist ja laienemist.
English: Granpidam contains the active substance sildenafil.
Estonian: Granpidam sisaldab toimeainena sildenafiili.
English: This is a summary of the European public assessment report (EPAR) for Granpidam.
Estonian: See on ravimi Granpidam Euroopa avaliku hindamisaruande kokkuvõte.
English: For more information about treatment with Granpidam, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Granpidamiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.