natgillin/translations-raw huggingface dataset:
PegIntron is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
PegIntron'i ei tohi kasutada raseduse ajal, kui see ei ole hädavajalik.
PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
PegIntron 50 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis PegIntron 80 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis PegIntron 100 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis PegIntron 120 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis PegIntron 150 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis Alfa-2b-peginterferoon
PegIntron 120 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
PegIntron 120 mikrogrammi süstelahuse pulber ja lahusti Viaalis sisalduv pulber lahustatakse 0,7 ml süstevees, mis on ette nähtud kuni 0,5 ml manustamiseks.
EU/1/00/131/047 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/048 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/050 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/1/00/131/047 (1 süstel, 1 süstlanõel ja 2 puhastustampooni) EU/1/00/131/048 (4 süstelit, 4 süstlanõela ja 8 puhastustampooni) EU/1/00/131/050 (12 süstelit, 12 süstlanõela ja 24 puhastustampooni)
PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen EU/1/00/131/031
PegIntron 50 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis EU/1/00/131/031
PegIntron 50 micrograms powder and solvent for solution for injection PegIntron 80 micrograms powder and solvent for solution for injection PegIntron 100 micrograms powder and solvent for solution for injection PegIntron 120 micrograms powder and solvent for solution for injection PegIntron 150 micrograms powder and solvent for solution for injection peginterferon alfa-2b
PegIntron 50 mikrogrammi süstelahuse pulber ja lahusti PegIntron 80 mikrogrammi süstelahuse pulber ja lahusti PegIntron 100 mikrogrammi süstelahuse pulber ja lahusti PegIntron 120 mikrogrammi süstelahuse pulber ja lahusti PegIntron 150 mikrogrammi süstelahuse pulber ja lahusti Alfa-2b-peginterferoon
PegIntron 150 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
PegIntron 150 mikrogrammi süstelahuse pulber ja lahusti Viaalis sisalduv pulber lahustatakse 0,7 ml süstevees, mis on ette nähtud kuni 0,5 ml manustamiseks.
EU/1/00/131/035 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/036 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/038 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/1/00/131/035 (1 süstel, 1 süstlanõel ja 2 puhastustampooni) EU/1/00/131/036 (4 süstlit, 4 süstlanõela ja 8 puhastustampooni) EU/1/00/131/038 (12 süstlit, 12 süstlanõela ja 24 puhastustampooni)
Pen label - PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen
Pen-süstli silt - PegIntron 150 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis
Careful co-administration of theophylline with the product (PegIntron) is recommended.
Soovitatav on PegIntroni ja teofülliini koos manustada ettevaatusega.
Pen label - PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen
Pen-süstli silt - PegIntron 80 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis
EU/1/00/131/043 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/044 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/046 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/1/00/131/043 (1 süstel, 1 süstlanõel ja 2 puhastustampooni) EU/1/00/131/044 (4 süstelit, 4 süstlanõela ja 8 puhastustampooni) EU/1/00/131/046 (12 süstelit, 12 süstlanõela ja 24 puhastustampooni)
EU/1/00/131/020 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/029 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/1/00/131/020 (6 viaali pulbriga, 6 ampulli lahustiga) EU/1/00/131/029 (12 viaali pulbriga, 12 ampulli lahustiga, 12 süstalt, 24 süstlanõela ja 12 puhastustampooni)
PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen (CLEARCLICK) is reconstituted with the solvent provided in the two-chamber cartridge (water for injections) for administration of up to 0.5 ml of solution.
PegIntron 150 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis Iga pen-süstli (CLEARCLICK) kahekambrilises kolbampullis asuva lahusti (süstevee) abil tuleb valmistada lahus kuni 0,5 ml manustamiseks.
PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen contains 80 micrograms of peginterferon alfa-2b measured on a protein basis.
PegIntron 80 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis Iga pen-süstel sisaldab valgu baasil mõõdetuna 80 mikrogrammi alfa-2b-peginterferooni.
EU/1/00/131/039 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/040 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/042 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/1/00/131/039 (1 süstel, 1 süstlanõel ja 2 puhastustampooni) EU/1/00/131/040 (4 süstelit, 4 süstlanõela ja 8 puhastustampooni) EU/1/00/131/042 (12 süstelit, 12 süstlanõela ja 24 puhastustampooni)
Table 2a Dose modification guidelines for combination therapy based on laboratory parameters
Tabel 2a Annuse korrigeerimise juhend kombinatsioonravi korral vastavalt laboratoorsetele parameetritele Laboratoorsed näitajad Vähendada ainult ribaviriini ööpäevast annust (vt märkus 1), kui
Pen label - PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen
Pen-süstli silt - PegIntron 100 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis
PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen (CLEARCLICK) is reconstituted with the solvent provided in the two-chamber cartridge (water for injections) for administration of up to 0.5 ml of solution.
PegIntron 120 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis Iga pen-süstli (CLEARCLICK) kahekambrilises kolbampullis asuva lahusti (süstevee) abil tuleb valmistada lahus kuni 0,5 ml manustamiseks.
PegIntron 50 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
PegIntron 50 mikrogrammi süstelahuse pulber ja lahusti Viaalis sisalduv pulber lahustatakse 0,7 ml süstevees, mis on ette nähtud kuni 0,5 ml manustamiseks.
Pen label - PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen
Pen-süstli silt - PegIntron 50 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis
PegIntron 100 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
PegIntron 100 mikrogrammi süstelahuse pulber ja lahusti Viaalis sisalduv pulber lahustatakse 0,7 ml süstevees, mis on ette nähtud kuni 0,5 ml manustamiseks.
PegIntron 150 micrograms powder and solvent for solution for injection Each vial contains 150 micrograms of peginterferon alfa-2b measured on a protein basis.
PegIntron 150 mikrogrammi süstelahuse pulber ja lahusti Iga viaal sisaldab valgu baasil mõõdetuna 150 mikrogrammi alfa-2b-peginterferooni.
PegIntron 120 micrograms powder and solvent for solution for injection Each vial contains 120 micrograms of peginterferon alfa-2b measured on a protein basis.
PegIntron 120 mikrogrammi süstelahuse pulber ja lahusti Iga viaal sisaldab valgu baasil mõõdetuna 120 mikrogrammi alfa-2b-peginterferooni.
PegIntron 150 micrograms powder for injection peginterferon alfa-2b
PegIntron 150 mikrogrammi süstelahuse pulber alfa-2b-peginterferoon s.c.
EU/1/00/131/031 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/032 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/034 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/1/00/131/031 (1 süstel, 1 süstlanõel ja 2 puhastustampooni) EU/1/00/131/032 (4 süstlit, 4 süstlanõela ja 8 puhastustampooni) EU/1/00/131/034 (12 süstlit, 12 süstlanõela ja 24 puhastustampooni)
EU/1/00/131/010 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/027 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/1/00/131/010 (6 viaali pulbriga, 6 ampulli lahustiga) EU/1/00/131/027 (12 viaali pulbriga, 12 ampulli lahustiga, 12 süstalt, 24 süstlanõela ja 12 puhastustampooni)
Common side effects (may affect up to 1 in 10 people): - fungal infection, common cold, cold sores, pharyngitis (sore throat), sinusitis, ear infection, coughing, throat pain, feeling cold, eye pain, - decrease in blood clotting cells called platelets, that may result in easy bruising and spontaneous bleeding, swollen glands (swollen lymph nodes), blood thyroid tests abnormalities, decrease in thyroid gland activity, which may make you feel tired, depressed, increase your sensitivity to cold and other symptoms, - wanting or attempting to harm yourself aggressive behaviour, agitation, anger, mood changes, nervousness or restlessness, depression, feeling anxious, trouble falling asleep or staying asleep, emotional instability, poor quality sleep, feeling sleepy, disturbance in attention.
Sagedased kõrvaltoimed (võivad tekkida kuni ühel inimesel 10st): - seeninfektsioon, külmetushaigused, ohatis, neelupõletik (kurguvalu), põskkoopapõletik, kõrvapõletik, köha, kurguvalu, külmatunne, silmavalu, - vereliistakuteks nimetatavate vere hüübimist võimaldavate rakkude arvu vähenemine, mis võib põhjustada sinikate kerget tekkimist või iseeneslikke veritsusi, näärmete turse (lümfisõlmede turse), kilpnäärmeanalüüside kõrvalekalded veres, kilpnäärmetalitluse vähenemine, mis võib põhjustada väsimus- või masendustunnet, suurendada teie tundlikkust külma suhtes ja teisi sümptomeid,
EU/1/00/131/015 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/028 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/1/00/131/015 (6 viaali pulbriga, 6 ampulli lahustiga) EU/1/00/131/028 (12 viaali pulbriga, 12 ampulli lahustiga, 12 süstalt, 24 süstlanõela ja 12 puhastustampooni)
PegIntron 120 micrograms powder for injection peginterferon alfa-2b
PegIntron 120 mikrogrammi süstelahuse pulber alfa-2b-peginterferoon s.c.
Response at treatment week
Vastus ravi lõpus Püsiv ravivastus
EU/1/00/131/005 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/026 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/1/00/131/005 (6 viaali pulbriga, 6 ampulli lahustiga) EU/1/00/131/026 (12 viaali pulbriga, 12 ampulli lahustiga, 12 süstalt, 24 süstlanõela ja 12 puhastustampooni)
PegIntron 80 micrograms powder for injection peginterferon alfa-2b
PegIntron 80 mikrogrammi süstelahuse pulber alfa-2b-peginterferoon s.c.
PegIntron 100 micrograms powder for injection peginterferon alfa-2b
PegIntron 100 mikrogrammi süstelahuse pulber alfa-2b-peginterferoon s.c.
PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen contains 120 micrograms of peginterferon alfa-2b measured on a protein basis.
PegIntron 120 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis Iga pen-süstel sisaldab valgu baasil mõõdetuna 120 mikrogrammi alfa-2b-peginterferooni.
PegIntron 50 micrograms powder and solvent for solution for injection Each vial contains 50 micrograms of peginterferon alfa-2b measured on a protein basis.
PegIntron 50 mikrogrammi süstelahuse pulber ja lahusti Iga viaal sisaldab valgu baasil mõõdetuna 50 mikrogrammi alfa-2b-peginterferooni.
PegIntron 50 micrograms powder for injection peginterferon alfa-2b
PegIntron 50 mikrogrammi süstelahuse pulber alfa-2b-peginterferoon s.c.
PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen (CLEARCLICK) is reconstituted with the solvent provided in the two-chamber cartridge (water for injections) for administration of up to 0.5 ml of solution.
PegIntron 50 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis Iga pen-süstli (CLEARCLICK) kahekambrilises kolbampullis asuva lahusti (süstevee) abil tuleb valmistada lahus kuni 0,5 ml manustamiseks.
EU/1/00/131/025 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/030 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/1/00/131/025 (6 viaali pulbriga, 6 ampulli lahustiga) EU/1/00/131/030 (12 viaali pulbriga, 12 ampulli lahustiga, 12 süstalt, 24 süstlanõela ja 12 puhastustampooni)
PegIntron 80 micrograms powder and solvent for injection peginterferon alfa-2b
PegIntron 80 mikrogrammisüstelahuse pulber ja lahusti alfa-2b-peginterferoon
PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen contains 150 micrograms of peginterferon alfa-2b measured on a protein basis.
PegIntron 150 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis Iga pen-süstel sisaldab valgu baasil mõõdetuna 150 mikrogrammi alfa-2b-peginterferooni.
PegIntron 100 micrograms powder and solvent for solution for injection Each vial contains 100 micrograms of peginterferon alfa-2b measured on a protein basis.
PegIntron 100 mikrogrammi süstelahuse pulber ja lahusti Iga viaal sisaldab valgu baasil mõõdetuna 100 mikrogrammi alfa-2b-peginterferooni.
PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen
PegIntron 50 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis PegIntron 80 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis PegIntron 100 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis PegIntron 120 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis PegIntron 150 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis
PegIntron 150 micrograms powder and solvent for injection peginterferon alfa-2b
PegIntron 150 mikrogrammi süstelahuse pulber ja lahusti alfa-2b-peginterferoon
PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen (CLEARCLICK) is reconstituted with the solvent provided in the two-chamber cartridge (water for injections) for administration of up to 0.5 ml of solution.
PegIntron 100 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis Iga pen-süstli (CLEARCLICK) kahekambrilises kolbampullis asuva lahusti (süstevee) abil tuleb valmistada lahus kuni 0,5 ml manustamiseks.
PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen contains 50 micrograms of peginterferon alfa-2b measured on a protein basis.
PegIntron 50 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis Iga pen-süstel sisaldab valgu baasil mõõdetuna 50 mikrogrammi alfa-2b-peginterferooni.
Very common side effects (may affect more than 1 in 10 people): - feeling depressed, irritability, trouble falling asleep or staying asleep, feeling anxious or nervous, difficulty concentrating, mood swings, - headache, dizziness, tired feeling, shaking chills, fever, flu-like symptoms, virus infection,
Väga sagedased kõrvaltoimed (võivad tekkida rohkem kui ühel inimesel 10st): - masendus (depressioon), ärrituvus, uinumisraskused või unetus, ärevustunne või närvilisus,
PegIntron 50 micrograms powder and solvent for injection peginterferon alfa-2b
PegIntron 50 mikrogrammi süstelahuse pulber ja lahusti alfa-2b-peginterferoon
Plasma HCV-RNA is measured with a research-based quantitative polymerase chain reaction assay by a central laboratory *Intent to treat population includes 7 patients for whom at least 12 weeks of prior therapy could not be confirmed.
* Ravi sihtpopulatsioon hõlmab 7 patsienti, kellel ei suudetud tõestada, et nad said eelnevat vähemalt 12-nädalast ravi.
PegIntron 120 micrograms powder and solvent for injection peginterferon alfa-2b
PegIntron 120 mikrogrammi süstelahuse pulber ja lahusti alfa-2b-peginterferoon
PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen contains 100 micrograms of peginterferon alfa-2b measured on a protein basis.
PegIntron 100 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis Iga pen-süstel sisaldab valgu baasil mõõdetuna 100 mikrogrammi alfa-2b-peginterferooni.
PegIntron 100 micrograms powder and solvent for injection peginterferon alfa-2b
PegIntron 100 mikrogrammi süstelahuse pulber ja lahusti alfa-2b-peginterferoon
What PegIntron contains
PegIntron lahusti Süstevesi
EU/1/00/131/008 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/009 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
EU/1/00/131/006 (1 viaal pulbriga, 1 ampull lahustiga) EU/1/00/131/007 (1 viaal pulbriga, 1 ampull lahustiga, 1 süstal, 2 süstlanõela ja 1 puhastustampoon) EU/1/00/131/008 (4 viaali pulbriga, 4 ampulli lahustiga) EU/1/00/131/009 (4 viaali pulbriga, 4 ampulli lahustiga, 4 süstalt, 8 süstlanõela ja 4 puhastustampooni)
PegIntron 50 micrograms powder and solvent for solution for injection PegIntron 80 micrograms powder and solvent for solution for injection PegIntron 100 micrograms powder and solvent for solution for injection PegIntron 120 micrograms powder and solvent for solution for injection PegIntron 150 micrograms powder and solvent for solution for injection
PegIntron 50 mikrogrammi süstelahuse pulber ja lahusti PegIntron 80 mikrogrammi süstelahuse pulber ja lahusti PegIntron 100 mikrogrammi süstelahuse pulber ja lahusti PegIntron 120 mikrogrammi süstelahuse pulber ja lahusti PegIntron 150 mikrogrammi süstelahuse pulber ja lahusti
EU/1/00/131/003 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/004 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
EU/1/00/131/001 (1 viaal pulbriga, 1 ampull lahustiga) EU/1/00/131/002 (1 viaal pulbriga, 1 ampull lahustiga, 1 süstal, 2 süstlanõela ja 1 puhastustampoon) EU/1/00/131/003 (4 viaali pulbriga, 4 ampulli lahustiga) EU/1/00/131/004 (4 viaali pulbriga, 4 ampulli lahustiga, 4 süstalt, 8 süstlanõela ja 4 puhastustampooni)
PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
PegIntron 120 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis alfa-2b-peginterferoon
PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
PegIntron 80 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis alfa-2b-peginterferoon
PegIntron 1.5 micrograms/kg
PegIntron 1,5 μg/kg
PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
PegIntron 50 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis alfa-2b-peginterferoon
EU/1/00/131/018 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/019 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
EU/1/00/131/016 (1 viaal pulbriga, 1 ampull lahustiga) EU/1/00/131/017 (1 viaal pulbriga, 1 ampull lahustiga, 1 süstal, 2 süstlanõela ja 1 puhastustampoon) EU/1/00/131/018 (4 viaali pulbriga, 4 ampulli lahustiga) EU/1/00/131/019 (4 viaali pulbriga, 4 ampulli lahustiga, 4 süstalt, 8 süstlanõela ja 4 puhastustampooni)
PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
PegIntron 150 mikrogrammi süstelahuse pulber ja lahusti pen-süstlis alfa-2b-peginterferoon
Careful co-administration of thioridazine with the product (PegIntron) is recommended.
Soovitatav on PegIntroni ja tioridasiini koos manustada ettevaatusega.
PC:
Harv:
Both active substances have been available in the European Union (EU) as separate preparations for a number of years.
Mõlemat toimeainet on Euroopa Liidus aastaid turustatud eraldi ravimpreparaatidena.
What measures are being taken to ensure the safe and effective use of Omidria?
Mis meetmed võetakse, et tagada Omidria ohutu ja efektiivne kasutamine?
A risk management plan has been developed to ensure that Omidria is used as safely as possible.
Töötati välja riskijuhtimiskava, et tagada Omidria võimalikult ohutu kasutamine.
The full EPAR and risk management plan summary for Omidria can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Omidria kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Omidria on 28 July 2015.
Euroopa Komisjon andis Omidria müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 28. juulil
Other information about Omidria
Muu teave Omidria kohta
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom aktiveerib need, põhjustades nende lihaste kokkutõmbumist.
Although the effect of Omidria on pain was modest, it was considered clinically important.
Kuigi Omidria toime valule oli tagasihoidlik, peeti seda kliiniliselt oluliseks.
This makes lens replacement surgery easier.
See teeb silmaläätse vahetamise operatsiooni lihtsamaks.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Omidria are greater than its risks and recommended that it be approved for use in the EU.
Inimravimite komitee otsustas, et Omidria kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
In addition, 7% (29 out of 403) of patients receiving Omidria experienced moderate-to-severe pain compared with 14% (57 out of 403) of patients given placebo, and 25% (104 out of 403) were painfree in the early period following surgery, compared with 17% (69 out of 403) of patients receiving placebo.
Lisaks tundis 7% (29 patsienti 403st) Omidriat saanud patsientidest mõõdukat kuni tugevat valu võrreldes 14%-ga (57 patsienti 403st) platseebot saanud patsientidest ning 25% (104 patsienti 403st) ei tundnud vahetult operatsioonijärgsel ajal valu võrreldes 17%-ga (69 patsienti 403st) platseebot saanud patsientidest.
What is Omidria and what is it used for?
Mis on Omidria ja milleks seda kasutatakse?
Why is Omidria approved?
Miks Omidria heaks kiideti?
The most common side effects with Omidria (which may affect up to 1 in 10 people) are eye pain, anterior chamber inflammation (inflammation of the fluid-filled space inside the eye between the iris and the cornea), conjunctival hyperaemia (redness of the membrane that lies over the white part of the eye), photophobia (increased sensitivity of the eyes to light), corneal oedema (swelling of the transparent layer in front of the eye that covers the pupil and iris) and inflammation.
Omidria kõige sagedamad kõrvalnähud (võivad esineda kuni 1 patsiendil 10st) on silmavalu, eeskambri (vedelikuga täidetud kamber silmas viker- ja sarvkesta vahel) põletik, sidekesta hüpereemia (silmamuna eesmist osa katva kesta punetus), valguskartus (silmade suurenenud valgustundlikkus), sarvkesta (silma eesmises osas pupilli ja vikerkesta katva läbipaistva kihi) turse ja põletik.