FrancophonIA/ELRC3.0 huggingface dataset:
English: Omnitrope 1.3 mg/ml powder and solvent for solution for injection
Estonian: Omnitrope 1,3 mg/ml süstelahuse pulber ja lahusti
English: Long-term treatment and improvement of body composition of children with growth disturbance due to Prader-Willi syndrome
Estonian: Prader-Willi sündroomist põhjustatud kasvuhäiretega laste pikaajaline ravi ja kehaehituse paranemine
English: A subcutaneous dose of 5 mg of Omnitrope 15 mg/1.5 ml solution for injection in healthy adults results in plasma Cmax and tmax values of 52 ± 19 µg/l and 3.7 ± 1.2 hours, respectively.
Estonian: 5 mg Omnitrope 15 mg/1,5 ml süstelahuse subkutaansel manustamisel täiskasvanutele on plasma Cmax ja tmax väärtused vastavalt 52 ± 19 μg/l ja 3,7 ± 1,2 tundi.
English: After reconstitution, one vial contains 5 mg somatropin* (corresponding to 15 IU) per ml.
Estonian: Pärast valmistamist sisaldab üks viaal 5 mg somatropiini* (vastab 15 RÜ-le) 1 ml kohta.
English: 1 cartridge for SurePal 10 5 cartridges for SurePal 10 10 cartridges for SurePal 10
Estonian: 1 kolbampull süstevahendile SurePal 10 5 kolbampulli süstevahendile SurePal 10 10 kolbampulli süstevahendile SurePal 10
English: Omnitrope 5 mg/1.5 ml solution for injection Omnitrope 10 mg/1.5 ml solution for injection
Estonian: Omnitrope 5 mg/1,5 ml süstelahus Omnitrope 10 mg/1,5 ml süstelahus
English: INFORMATION IN BRAILLE Omnitrope 5 mg/ml
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Omnitrope 5 mg/ml
English: Your doctor will show you how to inject Omnitrope.
Estonian: Arst või hooldaja näitab teile, kuidas ravimit Omnitrope süstida.
English: 0.025-0.035 mg/kg body weight per day or 0.7-1.0 mg/m2 body surface area per day.
Estonian: 0,025...0,035 mg/kg kehakaalu kohta ööpäevas või 0,7...1,0 mg/m2 kehapindala kohta ööpäevas.
English: If you get any side effects, talk to your doctor or pharmacist or nurse.
Estonian: Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti või apteekri või meditsiiniõega.
English: What Omnitrope 10 mg/1.5 ml contains
Estonian: Mida Omnitrope 10 mg/1,5 ml sisaldab
English: A subcutaneous dose of 5 mg of Omnitrope 5 mg/1.5 ml solution for injection in healthy adults results in plasma Cmax and tmax values of 72 ± 28 µg/l and 4.0 ± 2.0 hours, respectively.
Estonian: 5 mg Omnitrope 5 mg/1,5 ml süstelahuse subkutaansel manustamisel täiskasvanutele on plasma Cmax ja tmax väärtused vastavalt 72 ± 28 μg/l ja 4,0 ± 2,0 tundi.
English: Growth hormone deficient adult patients
Estonian: Kasvuhormooni vaegusega täiskasvanud
English: A subcutaneous dose of 5 mg of Omnitrope 10 mg/1.5 ml solution for injection in healthy adults results in plasma Cmax and tmax values of 74 ± 22 µg/l and 3.9 ± 1.2 hours, respectively.
Estonian: 5 mg Omnitrope 10 mg/1,5 ml süstelahuse subkutaansel manustamisel täiskasvanutele on plasma Cmax ja tmax väärtused vastavalt 74 ± 22 μg/l ja 3,9 ± 1,2 tundi.
English: Omnitrope 5 mg/ml powder and solvent for solution for injection
Estonian: Omnitrope 5 mg/ml süstelahuse pulber ja lahusti
English: Omnitrope 10 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge.
Estonian: Omnitrope 10 mg/1,5 ml on steriilne, kasutamisvalmis, nahaaluselt manustatav süstelahus klaasist kolbampullis.
English: Do not share your pen.
Estonian: Ärge kasutage oma süstevahendit teistega ühiselt.
English: Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include:
Estonian: Aeg-ajalt esinevate kõrvaltoimete (esinevad tõenäoliselt vähem kui ühel patsiendil 100st) hulka kuuluvad järgmised kõrvaltoimed.
English: - Take the vial with the powder and push the needle through the rubber membrane of the vial.
Estonian: - Võtke pulbrit sisaldav viaal ja torgake nõel läbi viaali kummikorgi.
English: Tabulated list of adverse reactions
Estonian: Kõrvaltoimete loendi tabel
English: There have been rare cases of sudden death in patients with Prader-Willi syndrome.
Estonian: Praderi-Willi sündroomiga patsientidel on harvadel juhtudel esinenud äkksurm.
English: • Reddening, itchiness or pain at the injection site
Estonian: • Punetus, sügelus või valu süstekohal.
English: Injecting Omnitrope
Estonian: Omnitrope süstimine
English: However, the in-use stability has been demonstrated for up to 24 hours at 2°C - 8°C, in the original package.
Estonian: Kasutuskõlblik on lahus 2 °C…8 °C juures originaalpakendis säilitades siiski veel 24 tunni möödumisel.
English: Fatty tissue of the skin can shrink at the site of injection.
Estonian: Naha rasvkude võib süstekohal kokku tõmmata.
English: Omnitrope 10 mg/1.5 ml solution for injection disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol water for injections
Estonian: Omnitrope 10 mg/1,5 ml süstelahus dinaatriumvesinikfosfaat heptahüdraat naatriumdivesinikfosfaat dihüdraat glütsiin poloksameer 188 fenool süstevesi
English: - Omnitrope is given as an injection under the skin.
Estonian: - Ravim Omnitrope manustatakse süstena naha alla.
English: Omnitrope 5 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge.
Estonian: Omnitrope 5 mg/1,5 ml on steriilne, kasutamisvalmis, nahaaluselt manustatav süstelahus klaasist kolbampullis.
English: Omnitrope 10 mg/1.5 ml solution for injection is for use in SurePal 10 only.
Estonian: Omnitrope 10 mg/1,5 ml süstelahus on ette nähtud kasutamiseks ainult süstevahendiga SurePal 10.
English: Lipid metabolism
Estonian: Lipiidide ainevahetus
English: Omnitrope 15 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge.
Estonian: Omnitrope 15 mg/1,5 ml on steriilne, kasutamisvalmis, nahaaluselt manustatav süstelahus klaasist kolbampullis.
English: What Omnitrope 5 mg/1.5 ml contains
Estonian: Mida Omnitrope 5 mg/1,5 ml sisaldab
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 1.3 mg/ml powder and solvent for solution for injection Somatropin
Estonian: RAVIMPREPARAADI NIMETUS Omnitrope 1,3 mg/ml süstelahuse pulber ja lahusti Somatropiin
English: INFORMATION IN BRAILLE Omnitrope 1.3 mg/ml
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Omnitrope 1,3 mg/ml
English: - Take the needle off the pen using the outer needle cap, and discard the needle.
Estonian: - Eemaldage nõel süstevahendi küljest, asetades peale nõelakatte, ja visake see minema.
English: Other adverse drug reactions
Estonian: Teised kõrvaltoimed
English: One cartridge contains 1.5 ml corresponding to 5 mg somatropin (15 IU).
Estonian: Üks kolbampull sisaldab 1,5 ml, mis vastab 5 mg somatropiinile (15 RÜ).
English: Use the transfer set for transferring the solvent from the cartridge into the vial.
Estonian: Lahusti üleviimiseks kolbampullist viaali kasutage ülekandemehhanismi.
English: Omnitrope 15 mg/1.5 ml solution for injection is for use in SurePal 15 only.
Estonian: Omnitrope 15 mg/1,5 ml süstelahus on ette nähtud kasutamiseks ainult süstevahendiga SurePal 15.
English: Clinical response and side effects may also be used as guidance for dose titration.
Estonian: Annuse tiitrimisel võib lähtuda ka kliinilisest ravivastusest ja kõrvaltoimetest.
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 5 mg/ml powder and solvent for solution for injection Somatropin
Estonian: RAVIMPREPARAADI NIMETUS Omnitrope 5 mg/ml süstelahuse pulber ja lahusti Somatropiin
English: One cartridge contains 1.5 ml corresponding to 15 mg somatropin (45 IU).
Estonian: Üks kolbampull sisaldab 1,5 ml, mis vastab 15 mg somatropiinile (45 RÜ).
English: Musculoskeletal , Connective Tissue and Bone Disorders
Estonian: Lihas-skeleti ja sidekoe kahjustused
English: After reconstitution, one cartridge contains 5 mg somatropin (corresponding to 15 IU) per ml.
Estonian: Pärast lahustamist sisaldab üks kolbampull 5 mg somatropiini (vastab 15 RÜ-le) 1 ml-s.
English: After reconstitution, one vial contains 1.3 mg somatropin* (corresponding to 4 IU) per ml.
Estonian: Pärast valmistamist sisaldab 1,3 mg somatropiini* (vastab 4 RÜ-le) 1 ml kohta.
English: It should only be administered with the Omnitrope Pen 5, an injection device specifically developed for use with Omnitrope 5 mg/1.5 ml solution for injection.
Estonian: Seda tohib kasutada ainult koos Omnitrope Pen 5 süstevahendiga, mis on kujundatud spetsiaalselt Omnitrope 5 mg/1,5 ml süstelahuse manustamiseks.
English: 0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day.
Estonian: 0,045...0,050 mg/kg kehakaalu kohta ööpäevas või 1,4 mg/m2 kehapindala kohta ööpäevas.
English: INFORMATION IN BRAILLE Omnitrope 15 mg/1.5 ml
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Omnitrope 15 mg/1,5 ml
English: - Prader-Willi syndrome (PWS), for improvement of growth and body composition.
Estonian: - Kasvupeetuse ravi ja kehaehituse parandamine Praderi-Willi sündroomi (PWS) korral.
English: Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, mannitol, poloxamer 188, benzyl alcohol, water for injections.
Estonian: Muud koostisained: dinaatriumvesinikfosfaat heptahüdraat, naatriumdivesinikfosfaat dihüdraat, mannitool, poloksameer 188, bensüülalkohol, süstevesi.
English: Follow the Instructions for Use of the pen injector.
Estonian: Järgige süstevahendi kasutusjuhendit.
English: It should only be administered with the Omnitrope Pen 10, an injection device specifically developed for use with Omnitrope 10 mg/1.5 ml solution for injection.
Estonian: Seda tohib kasutada ainult koos Omnitrope Pen 10 süstevahendiga, mis on kujundatud spetsiaalselt Omnitrope 10 mg/1,5 ml süstelahuse manustamiseks.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 5 mg/ml powder for solution for injection Somatropin
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Omnitrope 5 mg/ml süstelahuse pulber Somatropiin s.c.
English: After reconstitution, one vial contains 1.3 mg somatropin (corresponding to 4 IU) per ml.
Estonian: Üks pulbriga viaal sisaldab 1,3 mg somatropiini (vastab 4 RÜ-le).
English: - Transfer all of the dissolved solution back into the cartridge using the transfer set.
Estonian: - Viige kogu lahus ülekandemehhanismi abil tagasi kolbampulli.
English: INFORMATION IN BRAILLE Omnitrope 10 mg/1.5 ml
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Omnitrope 10 mg/1,5 ml
English: Omnitrope 5 mg/1.5 ml in a cartridge for SurePal 5 is intended for multiple use.
Estonian: Omnitrope 5 mg/1,5 ml kolbampullis süstevahendile SurePal 5 on ette nähtud korduvaks manustamiseks.
English: Omnitrope 5 mg/1.5 ml solution for injection is for use in SurePal 5 only.
Estonian: Omnitrope 5 mg/1,5 ml süstelahus on ette nähtud kasutamiseks ainult süstevahendiga SurePal 5.
English: INFORMATION IN BRAILLE Omnitrope 5 mg/1.5 ml
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Omnitrope 5 mg/1,5 ml
English: What Omnitrope 15 mg/1.5 ml contains
Estonian: Mida Omnitrope 15 mg/1,5 ml sisaldab
English: Children with chronic renal (kidney) insufficiency
Estonian: Kroonilise neerupuudulikkusega lapsed
English: Read package leaflet before use.
Estonian: - Enne manustamist vaadelge valmislahust.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON LABEL
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VÄLISPAKENDI SILT
English: Arthralgia* Myalgia* Musculoskeletal stiffness*
Estonian: Liigesevalu* Lihasvalu* Skeletilihaste jäikus*
English: Omnitrope 10 mg/1.5 ml solution for injection EU/1/06/332/007
Estonian: Omnitrope 10 mg/1,5 ml süstelahus EU/1/06/332/007
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/007
Estonian: MÜÜGILOA NUMBRID EU/1/06/332/007
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Solvent for Omnitrope (water for injections) Subcutaneous use.
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE Omnitrope lahusti (süstevesi)
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 10 mg/1.5 ml solution for injection Somatropin
Estonian: RAVIMPREPARAADI NIMETUS Omnitrope 10 mg/1,5 ml süstelahus Somatropiin
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 1.3 mg/ml powder for solution for injection Somatropin
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE Omnitrope 1,3 mg/ml süstelahuse pulber Somatropiin s.c.
English: It should only be administered with the Omnitrope Pen L, an injection device specifically developed for use with Omnitrope 5 mg/ml reconstituted solution for injection.
Estonian: Seda tohib kasutada ainult koos Omnitrope Pen L süstevahendiga, mis on kujundatud spetsiaalselt Omnitrope 5 mg/ml lahuse manustamiseks.
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/016
Estonian: MÜÜGILOA NUMBRID EU/1/06/332/016
English: Omnitrope 10 mg/1.5 ml in a cartridge for SurePal 10 is intended for multiple use.
Estonian: Omnitrope 10 mg/1,5 ml kolbampullis süstevahendile SurePal 10 on ette nähtud korduvaks manustamiseks.
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 15 mg/1.5 ml solution for injection Somatropin
Estonian: RAVIMPREPARAADI NIMETUS Omnitrope 15 mg/1,5 ml süstelahus Somatropiin
English: One vial contains 1.3 mg (corresponding to 4 IU) of somatropin after reconstitution with 1 ml solvent.
Estonian: Üks viaal sisaldab pärast lahustamist 1 ml lahustis 1,3 mg (vastab 4 RÜ-le) somatropiini.
English: A dose of 0.045 - 0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day is recommended.
Estonian: Soovitatav annus on 0,045...0,050 mg/kg kehakaalu kohta ööpäevas või 1,4 mg/m2 kehapinna kohta ööpäevas.
English: Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, glycine, poloxamer 188, phenol, water for injections.
Estonian: Muud koostisained: dinaatriumvesinikfosfaat heptahüdraat, naatriumdivesinikfosfaat dihüdraat, glütsiin, poloksameer 188, fenool, süstevesi.
English: Disinfect the rubber membrane of the cartridge with a cleansing swab Insert the cartridge into SurePal following the instructions for use provided with the pen.
Estonian: Sisestage kolbampull SurePal süstevahendisse, järgides süstevahendiga kaasasolevaid kasutusjuhiseid.
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/013
Estonian: MÜÜGILOA NUMBRID EU/1/06/332/013
English: Omnitrope 15 mg/1.5 ml in a cartridge for SurePal 15 is intended for multiple use.
Estonian: Omnitrope 15 mg/1,5 ml kolbampullis süstevahendile SurePal 15 on ette nähtud korduvaks manustamiseks.
English: Omnitrope 10 mg/1.5 ml solution for injection
Estonian: Omnitrope 10 mg/1,5 ml süstelahus
English: Inject the solvent slowly.
Estonian: Süstige lahusti aeglaselt pulbriviaali.
English: Omnitrope 10 mg/1.5 ml solution for injection EU/1/06/332/016
Estonian: Omnitrope 10 mg/1,5 ml süstelahus EU/1/06/332/016
English: Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, poloxamer 188, phenol, water for injections.
Estonian: Muud koostisained: dinaatriumvesinikfosfaat heptahüdraat, naatriumdivesinikfosfaat dihüdraat, naatriumkloriid, poloksameer 188, fenool, süstevesi.
English: Omnitrope 5 mg/1.5 ml solution for injection EU/1/06/332/004
Estonian: Omnitrope 5 mg/1,5 ml süstelahus EU/1/06/332/004
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/004
Estonian: MÜÜGILOA NUMBRID EU/1/06/332/004
English: - Use the transfer set for transferring all the solvent from the cartridge into the vial.
Estonian: - Lahusti üleviimiseks kolbampullist viaali kasutage ülekandemehhanismi.
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 5 mg/1.5 ml solution for injection Somatropin
Estonian: RAVIMPREPARAADI NIMETUS Omnitrope 5 mg/1,5 ml süstelahus Somatropiin
English: Common side effects (likely to occur in fewer than 1 in 10 patients) include:
Estonian: Sageli esinevate kõrvaltoimete (esinevad tõenäoliselt vähem kui ühel patsiendil 10st) hulka kuuluvad järgmised kõrvaltoimed.
English: It should only be administered with SurePal 15, an injection device specifically developed for use with Omnitrope 15 mg/1.5 ml solution for injection.
Estonian: Seda tohib kasutada ainult koos SurePal 15 süstevahendiga, mis on kujundatud spetsiaalselt Omnitrope 15 mg/1,5 ml süstelahuse manustamiseks.
English: Omnitrope 15 mg/1.5 ml solution for injection EU/1/06/332/010
Estonian: Omnitrope 15 mg/1,5 ml süstelahus EU/1/06/332/010
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/010
Estonian: MÜÜGILOA NUMBRID EU/1/06/332/010
English: It should only be administered with SurePal 5, an injection device specifically developed for use with Omnitrope 5 mg/1.5 ml solution for injection.
Estonian: Seda tohib kasutada ainult koos SurePal 5 süstevahendiga, mis on kujundatud spetsiaalselt Omnitrope 5 mg/1,5 ml süstelahuse manustamiseks.
English: It should only be administered with SurePal 10, an injection device specifically developed for use with Omnitrope 10 mg/1.5 ml solution for injection.
Estonian: Seda tohib kasutada ainult koos SurePal 10 süstevahendiga, mis on kujundatud spetsiaalselt Omnitrope 10 mg/1,5 ml süstelahuse manustamiseks.
English: Omnitrope 15 mg/1.5 ml solution for injection
Estonian: Omnitrope 15 mg/1,5 ml süstelahus
English: 5 cartridges for SurePal 5 10 cartridges for SurePal 5
Estonian: 1 kolbampull süstevahendile SurePal 5 5 kolbampulli süstevahendile SurePal 5 10 kolbampulli süstevahendile SurePal 5
English: Omnitrope 5 mg/1.5 ml solution for injection EU/1/06/332/013
Estonian: Omnitrope 5 mg/1,5 ml süstelahus EU/1/06/332/013
English: PHARMACEUTICAL FORM AND CONTENTS 1 vial of 1.3 mg powder
Estonian: RAVIMVORM JA PAKENDI SUURUS 1 viaal 1,3 mg pulbriga 1 viaal 1 ml lahustiga Pakendis on 1 komplekt.
English: Powder: glycine, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate Solvent: water for injections
Estonian: Pulber: glütsiin, dinaatriumvesinikfosfaat heptahüdraat, naatriumdivesinikfosfaat dihüdraat.
English: Biochemiestr.
Estonian: Süstelahus.
English: It should only be administered with the Omnitrope Pen L, an injection device specifically developed for use with Omnitrope 5 mg/ml powder and solvent for solution for injection.
Estonian: Ravimi manustamiseks kasutage üksnes spetsiaalset Omnitrope Pen L süstevahendit, mis on kujundatud spetsiaalselt Omnitrope 5 mg/ml süstelahuse manustamiseks.
English: Each ml of solution contains 6.7 mg of somatropin (corresponding to 20 IU) One cartridge contains 10.0 mg (corresponding to 30 IU) of somatropin in 1.5 ml.
Estonian: Üks kolbampull sisaldab 10,0 mg (vastab 30 RÜ-le) somatropiini 1,5 ml-s.
English: Omnitrope 5 mg/1.5 ml solution for injection
Estonian: Omnitrope 5 mg/1,5 ml süstelahus
English: Shelf life after reconstitution
Estonian: Kõlblikkusaeg pärast lahustamist
English: The content must be clear and colourless after reconstitution.
Estonian: Pärast lahustamist peab viaali sisu olema läbipaistev ja värvitu.
English: - a sterile, disposable syringe of appropriate size (e.g. 1 ml syringe)
Estonian: Ravimi Omnitrope süstitava annuse mõõtmine - Võtke sobiva suurusega steriilne, ühekordselt kasutatav süstal (nt
English: The manufacturer's instructions with each pen must be followed for loading the cartridge, attaching the injection needle and for the administration.
Estonian: Kolbampulli süstevahendisse asetamise, süstenõela kinnitamise ja ravimi manustamise osas tuleb järgida tootja juhiseid süstevahendi kasutamiseks.
English: Each ml of solution contains 3.3 mg of somatropin (corresponding to 10 IU) One cartridge contains 5.0 mg (corresponding to 15 IU) of somatropin in 1.5 ml.
Estonian: Üks klaasist kolbampull sisaldab 5,0 mg (mis vastab 15 RÜ-le) somatropiini 1,5 ml-s.
English: Musculoskeleta l stiffness*
Estonian: Lihasvalu* Skeletilihaste jäikus*
English: Small for gestational age
Estonian: Soovitatavad annused lastele
English: Measuring the dose of Omnitrope to be injected - Take the sterile, disposable syringe of appropriate size (e.g. 1 ml syringe) and injection needle (e.g. 0.25 mm x 8 mm).
Estonian: Lahusti eemaldamiseks viaalist kasutage steriilset ühekordselt kasutatavat süstalt (nt 2 ml süstalt) ja nõela (nt 0,33x12,7 mm).
English: MARKETING AUTHORISATION NUMBER EU/1/06/332/001
Estonian: MÜÜGILOA NUMBER EU/1/06/332/001
English: With a cleansing swab, disinfect both the rubber membrane of the vial with powder and the rubber membrane of the cartridge with solvent.
Estonian: Desinfitseerige alkoholiga immutatud vatitupsuga nii pulbri viaali kui lahustiga täidetud kolbampulli kummikorgid.
English: - The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol water for injections
Estonian: - Teised koostisosad on: dinaatriumvesinikfosfaat heptahüdraat; naatriumdivesinikfosfaat dihüdraat; glütsiin; poloksameer 188; fenool; süstevesi
English: Rarely, an inflammation of the pancreas has been reported in patients treated with growth hormone.
Estonian: Kasvuhormoonravi saavatel patsientidel on harva teatatud kõhunäärme põletikust.
English: - SurePal, an injection device specifically developed for use with
Estonian: - Omnitrope Pen süstevahend, mis on valmistatud spetsiaalselt
English: - The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate sodium chloride poloxamer 188 phenol water for injections
Estonian: - Teised koostisosad on: dinaatriumvesinikfosfaat heptahüdraat; naatriumdivesinikfosfaat dihüdraat; naatriumkloriid; poloksameer 188; fenool; süstevesi
English: Quality
Estonian: Kvaliteet
English: • The Committee considered the referral under Article 29(4) of Directive 2001/83/EC,
Estonian: • komitee arutas direktiivi 2001/83/EÜ artikli 29 lõike 4 kohast esildist.
English: • The Committee considered the totality of the data submitted by the applicant in relation to the objections raised as a potential serious risk to public health.
Estonian: • Komitee arutas kõiki taotleja esitatud andmeid seoses vastuväidetega võimaliku tõsise ohu kohta rahvatervisele.
English: The study was designed and powered to demonstrate superiority with a significant level of 5% one-sided, but the current requirement is now that a significance level of 2.5% one-sided, which the study could not reach.
Estonian: Uuring oli kavandatud nii, et tõendada paremust 5% olulisuse tasemega ühepoolses testis, kuid tänapäeval on nõutav 2,5% olulisuse tase ühepoolses testis, mida uuringuga ei saavutatud.
English: An effect was seen on the critical secondary endpoint of spontaneous pain visual analogue scale (VAS).
Estonian: Mõju täheldati teisese kriitilise tähtsusega näitaja, spontaanse valu visuaalse analoogskaala (VAS) skooris.
English: Clinical Pharmacology
Estonian: Kliiniline farmakoloogia
English: However, this study cannot be considered to provide confirmatory evidence on efficacy of Spraygel as the primary endpoint is not validated and statistical analysis does not meet regulatory requirements.
Estonian: Sellegipoolest ei saa selle uuringu alusel lõplikult tõendada geelsprei efektiivsust, sest esmane tulemusnäitaja ei ole valideeritud ning statistiline analüüs ei vasta regulatiivnõuetele.
English: Numerically, the exposure of Spraygel is lower than Emulgel and its impact on efficacy cannot be ascertained accurately.
Estonian: Arvandmeid arvestades on geelsprei ekspositsiooni ulatus väiksem kui Emulgelil ning selle mõju efektiivsusele ei ole võimalik täpselt tuvastada.
English: However, the systemic exposure is low enough that the adverse event profile seen with oral or other systemically administered NSAIDs is not problematic.
Estonian: Sellegipoolest on süsteemne ekspositsioon piisavalt väike, et suukaudsete või muude süsteemselt manustatavate NSAIDidega täheldatud kõrvalnähtude profiil ei tekita probleeme.
English: The qualitative comparison is based on composition, degree of ionization and complete solubility of active substance.
Estonian: Kvalitatiivne võrdlus põhines toimeaine koostisel, ionisatsioonimääral ja täielikul lahustuvusel.
English: Most of the data are cross-study comparisons which are affected by different doses and methods and so no robust conclusions can be drawn from these cross-study comparisons.
Estonian: Suurem osa andmetest on pärit uuringuvahelistest võrdlustest, kuid uuringutes kasutati erinevaid annuseid ja meetodeid, mistõttu ei saa nende võrdluste alusel teha kindlaid järeldusi.