FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/09/565/017 1 pre-filled syringe EU/1/09/565/018 1 pre-filled syringe with safety device EU/1/09/565/019 4 pre-filled syringes EU/1/09/565/020 4 pre-filled syringes with safety device EU/1/09/565/021 6 pre-filled syringes EU/1/09/565/022 6 pre-filled syringes with safety device EU/1/09/565/037 1 pre-filled syringe with safety needle EU/1/09/565/038 4 pre-filled syringes with safety needle EU/1/09/565/039 6 pre-filled syringes with safety needle
Estonian: EU/1/09/565/017 1 süstel EU/1/09/565/018 1 süstel, kaitseseadisega EU/1/09/565/019 4 süstlit EU/1/09/565/020 4 süstlit, kaitseseadisega EU/1/09/565/021 6 süstlit EU/1/09/565/022 6 süstlit, kaitseseadisega EU/1/09/565/037 1 süstel, turvanõelaga EU/1/09/565/038 4 süstlit, turvanõelaga EU/1/09/565/039 6 süstlit, turvanõelaga
English: EU/1/09/565/011 1 pre-filled syringe EU/1/09/565/012 1 pre-filled syringe with safety device EU/1/09/565/013 4 pre-filled syringes EU/1/09/565/014 4 pre-filled syringes with safety device EU/1/09/565/015 6 pre-filled syringes EU/1/09/565/016 6 pre-filled syringes with safety device EU/1/09/565/034 1 pre-filled syringe with safety needle EU/1/09/565/035 4 pre-filled syringes with safety needle EU/1/09/565/036 6 pre-filled syringes with safety needle
Estonian: EU/1/09/565/011 1 süstel EU/1/09/565/012 1 süstel, kaitseseadisega EU/1/09/565/013 4 süstlit EU/1/09/565/014 4 süstlit, kaitseseadisega EU/1/09/565/015 6 süstlit EU/1/09/565/016 6 süstlit, kaitseseadisega EU/1/09/565/034 1 süstel, turvanõelaga EU/1/09/565/035 4 süstlit, turvanõelaga EU/1/09/565/036 6 süstlit, turvanõelaga
English: Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe
Estonian: Biopoin 1000 RÜ/0,5 ml süstelahus süstlis Biopoin 2000 RÜ/0,5 ml süstelahus süstlis Biopoin 3000 RÜ/0,5 ml süstelahus süstlis Biopoin 4000 RÜ/0,5 ml süstelahus süstlis Biopoin 5000 RÜ/0,5 ml süstelahus süstlis
English: Biopoin 10,000 IU/1 ml
Estonian: Biopoin 10000 RÜ/1 ml
English: Subcutaneous administration: The initial posology is 20 IU/kg body weight 3 times per week.
Estonian: Subkutaanne manustamine: algannus on 20 RÜ/kg kehakaalu kohta 3 korda nädalas.
English: The initial dose for injections under the skin is 20 IU per kg of bodyweight, given 3 times per week.
Estonian: Nahaaluste süstide esialgne annus on 20 RÜ kg kehakaalu kohta 3 korda nädalas.
English: Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe 30 months
Estonian: Biopoin 5000 RÜ/0,5 ml süstelahus süstlis 30 kuud
English: The initial dose for injections into veins is 40 IU per kg of bodyweight, given 3 times per week.
Estonian: Veenisiseste süstide esialgne annus on 40 RÜ kg kehakaalu kohta 3 korda nädalas.
English: Epoetin theta treatment should be initiated by physicians experienced in the above-mentioned indications.
Estonian: Teetaepoetiiniga ravi võivad alustada ülalpool nimetatud näidustuste ravikogemusega arstid.
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment.
Estonian: Epoetiinraviga seoses on teatatud rasketest nahaga seotud kõrvaltoimetest, sealhulgas Stevensi-Johnsoni sündroomist (SJS) ja toksilisest epidermaalsest nekrolüüsist (TEN), mis võivad olla eluohtlikud või fataalsed.
English: Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe EU/1/09/565/023
Estonian: Biopoin 30 000 RÜ/1 ml süstelahus süstlis EU/1/09/565/023
English: Biopoin 4,000 IU/0.5 ml: One pre-filled syringe contains 4,000 international units (IU) (33.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 8,000 international units (IU) (66.7 micrograms) per ml.
Estonian: Biopoin 4000 RÜ/0,5 ml: üks süstel 0,5 ml süstelahusega sisaldab 4000 rahvusvahelist ühikut (RÜ) (33,3 mikrogrammi) teetaepoetiini, mis vastab 8000 RÜ (66,7 mikrogrammi) teetaepoetiinile ml kohta.
English: Biopoin 5,000 IU/0.5 ml: One pre-filled syringe contains 5,000 international units (IU) (41.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 10,000 international units (IU) (83.3 micrograms) per ml..
Estonian: Biopoin 5000 RÜ/0,5 ml: üks süstel 0,5 ml süstelahusega sisaldab 5000 rahvusvahelist ühikut (RÜ) (41,7 mikrogrammi) teetaepoetiini, mis vastab 10000 RÜ (83,3 mikrogrammi) teetaepoetiinile ml kohta.
English: EU/1/09/565/023 1 pre-filled syringe EU/1/09/565/024 1 pre-filled syringe with safety device EU/1/09/565/025 4 pre-filled syringes EU/1/09/565/026 4 pre-filled syringes with safety device EU/1/09/565/027 6 pre-filled syringes EU/1/09/565/028 6 pre-filled syringes with safety device EU/1/09/565/040 1 pre-filled syringe with safety needle EU/1/09/565/041 4 pre-filled syringes with safety needle EU/1/09/565/042 6 pre-filled syringes with safety needle
Estonian: EU/1/09/565/023 1 süstel EU/1/09/565/024 1 süstel, kaitseseadisega EU/1/09/565/025 4 süstlit EU/1/09/565/026 4 süstlit, kaitseseadisega EU/1/09/565/027 6 süstlit EU/1/09/565/028 6 süstlit, kaitseseadisega EU/1/09/565/040 1 süstel, turvanõelaga EU/1/09/565/041 4 süstlit, turvanõelaga EU/1/09/565/042 6 süstlit, turvanõelaga
English: Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe EU/1/09/565/017
Estonian: Biopoin 20 000 RÜ/1 ml süstelahus süstlis EU/1/09/565/017
English: Discontinuation of treatment with epoetin theta should be taken into account.
Estonian: Ravi teetaepoetiiniga tuleb katkestada.
English: 4 pre-filled syringes containing 1 ml.
Estonian: 4 1 ml süstlit.
English: 6 pre-filled syringes containing 1 ml.
Estonian: 6 1 ml süstlit.
English: One pre-filled syringe contains 20,000 international units (IU) (166.7 micrograms) epoetin theta in 1 ml solution for injection corresponding to 20,000 IU (166.7 micrograms) epoetin theta per ml.
Estonian: Üks süstel 1 ml süstelahusega sisaldab 20000 rahvusvahelist ühikut (RÜ) (166,7 mikrogrammi) teetaepoetiini, mis vastab 20000 RÜ (166,7 mikrogrammi) teetaepoetiinile ml kohta.
English: Biopoin 3,000 IU/0.5 ml: One pre-filled syringe contains 3,000 international units (IU) (25 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 6,000 international units (IU) (50 micrograms) per ml.
Estonian: Biopoin 3000 RÜ/0,5 ml:üks süstel 0,5 ml süstelahusega sisaldab 3000 rahvusvahelist ühikut (RÜ) (25 mikrogrammi) teetaepoetiini, mis vastab 6000 RÜ (50 mikrogrammi) teetaepoetiinile ml kohta.
English: The dose may be increased after 4 weeks to 40 IU/kg, 3 times per week, if the increase in haemoglobin is not adequate (< 1 g/dl [0.62 mmol/l] within 4 weeks).
Estonian: Kui hemoglobiini taseme tõus ei ole piisav (<1 g/dl [0,62 mmol/l] 4 nädalaga), võib annust 4 nädala pärast suurendada 40 RÜ/kg-ni 3 korda nädalas.
English: Non-clinical data with other epoetins reveal no special hazard for humans based on conventional studies of genotoxicity and toxicity to reproduction.
Estonian: Genotoksilisuse ja reproduktsioonitoksilisuse mittekliinilised uuringud ei ole näidanud teiste epoetiinide kahjulikku toimet inimesele.
English: Biopoin 1,000 IU/0.5 ml: One pre-filled syringe contains 1,000 international units (IU) (8.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 2,000 international units (IU) (16.7 micrograms) per ml.
Estonian: Biopoin 1000 RÜ/0,5 ml: üks süstel 0,5 ml süstelahusega sisaldab 1000 rahvusvahelist ühikut (RÜ) (8,3 mikrogrammi) teetaepoetiini, mis vastab 2000 RÜ (16,7 mikrogrammi) teetaepoetiinile ml kohta.
English: Biopoin 2,000 IU/0.5 ml: One pre-filled syringe contains 2,000 international units (IU) (16.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 4,000 international units (IU) (33.3 micrograms) per ml.
Estonian: Biopoin 2000 RÜ/0,5 ml: üks süstel 0,5 ml süstelahusega sisaldab 2000 rahvusvahelist ühikut (RÜ) (16,7 mikrogrammi) teetaepoetiini, mis vastab 4000 RÜ (33,3 mikrogrammi) teetaepoetiinile ml kohta.
English: Biopoin 4,000 IU/0.5 ml
Estonian: Biopoin 4000 RÜ/0,5 ml
English: One pre-filled syringe contains 4,000 international units (IU) (33.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 8,000 IU (66.7 micrograms) epoetin theta per ml.
Estonian: Üks süstel 0,5 ml süstelahusega sisaldab 4000 rahvusvahelist ühikut (RÜ) (33,3 mikrogrammi) teetaepoetiini, mis vastab 8000 RÜ (66,7 mikrogrammi) teetaepoetiinile ml kohta.
English: One pre-filled syringe contains 30,000 international units (IU) (250 micrograms) epoetin theta in 1 ml solution for injection corresponding to 30,000 IU (250 micrograms) epoetin theta per ml.
Estonian: Üks süstel 1 ml süstelahusega sisaldab 30000 rahvusvahelist ühikut (RÜ) (250 mikrogrammi) teetaepoetiini, mis vastab 30000 RÜ(250 mikrogrammi) teetaepoetiinile ml kohta.
English: Biopoin 1,000 IU/0.5 ml
Estonian: Biopoin 1000 RÜ/0,5 ml
English: Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy Effect on tumour growth
Estonian: Sümptomaatiline aneemia vähiga patsientidel, kes saavad kemoteraapiat mittemüeloidse pahaloomulise protsessi korral
English: Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe EU/1/09/565/011
Estonian: Biopoin 10 000 RÜ/1 ml süstelahus süstlis EU/1/09/565/011
English: One pre-filled syringe contains 3,000 international units (IU) (25 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 6,000 IU (50 micrograms) epoetin theta per ml.
Estonian: Üks süstel 0,5 ml süstelahusega sisaldab 3000 rahvusvahelist ühikut (RÜ) (25 mikrogrammi) teetaepoetiini, mis vastab 6000 RÜ (50 mikrogrammi) teetaepoetiinile ml kohta.
English: One pre-filled syringe contains 2,000 international units (IU) (16.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 4,000 IU (33.3 micrograms) epoetin theta per ml.
Estonian: Üks süstel 0,5 ml süstelahusega sisaldab 2000 rahvusvahelist ühikut (RÜ) (16,7 mikrogrammi) teetaepoetiini, mis vastab 4000 RÜ (33,3 mikrogrammi) teetaepoetiinile ml kohta.
English: Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy
Estonian: Sümptomaatiline aneemia vähiga patsientidel, kes saavad kemoteraapiat mittemüeloidsete pahaloomuliste protsesside korral
English: Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Estonian: 0,5 ml süstelahust süstlis (I tüüpi klass), millel on kolb (bromobutüülkumm) ja kork (tefloniseeritud klorobutüülkumm) ja süstenõel (roostevaba teras) või süstenõel (roostevaba teras) koos kaitsekattega (turvanõel) või süstenõel (roostevaba teras) koos kaitseseadisega.
English: Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Estonian: 1 ml süstelahust süstlis (I tüüpi klass), millel on kolb (bromobutüülkumm) ja kork (tefloniseeritud klorobutüülkumm) ja süstenõel (roostevaba teras) või süstenõel (roostevaba teras) koos kaitsekattega (turvanõel) või süstenõel (roostevaba teras) koos kaitseseadisega.
English: Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe 30 months
Estonian: Biopoin 20 000 RÜ/1 ml süstelahus süstlis 30 kuud
English: One pre-filled syringe contains 5,000 international units (IU) (41.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 10,000 IU (83.3 micrograms) epoetin theta per ml.
Estonian: Üks süstel 0,5 ml süstelahusega sisaldab 5000 rahvusvahelist ühikut (RÜ) (41,7 mikrogrammi) teetaepoetiini, mis vastab 10000 RÜ (83,3 mikrogrammi) teetaepoetiinile ml kohta.
English: 6 pre-filled syringes with safety device containing 0.5 ml.
Estonian: 6 0,5 ml süstlit, turvanõelaga.
English: Packs of 6 pre-filled syringes; 6 pre-filled syringes with safety needle or 6 pre-filled syringes with safety device.
Estonian: 6 süstlit; 6 süstlit koos turvanõelaga või 6 süstlit koos kaitseseadisega sisaldavad pakendid
English: Biopoin 3,000 IU/0.5 ml
Estonian: Biopoin 3000 RÜ/0,5 ml
English: Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe 30 months
Estonian: Biopoin 10 000 RÜ/1 ml süstelahus süstlis 30 kuud
English: Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/565/007
Estonian: Biopoin 4000 RÜ/0,5 ml süstelahus süstlis EU/1/09/565/007
English: One pre-filled syringe contains 10,000 international units (IU) (83.3 micrograms) epoetin theta in 1 ml solution for injection corresponding to 10,000 IU (83.3 micrograms) epoetin theta per ml.
Estonian: Üks süstel 1 ml süstelahusega sisaldab 10000 rahvusvahelist ühikut (RÜ) (83,3 mikrogrammi) teetaepoetiini, mis vastab 10000 RÜ(83,3 mikrogrammi) teetaepoetiinile ml kohta.
English: Biopoin 5,000 IU/0.5 ml
Estonian: Biopoin 5000 RÜ/0,5 ml
English: To give yourself an injection into the tissue under the skin you will need: - a pre-filled syringe of Biopoin, - an alcohol wipe, - a piece of gauze bandage or a sterile gauze swab.
Estonian: Nahaalusesse koesse endale süsti tegemiseks on vaja: Biopoini süstlit, alkoholiga niisutatud puhastuslappi, tükki marlisidet või steriilset marlitampooni,
English: Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe 30 months
Estonian: Biopoin 30 000 RÜ/1 ml süstelahus süstlis 30 kuud
English: One pre-filled syringe contains 1,000 international units (IU) (8.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 2,000 IU (16.7 micrograms) epoetin theta per ml.
Estonian: Üks süstel 0,5 ml süstelahusega sisaldab 1000 rahvusvahelist ühikut (RÜ) (8,3 mikrogrammi) teetaepoetiini, mis vastab 2000 RÜ (16,7 mikrogrammi) teetaepoetiinile ml kohta.
English: EU/1/09/565/004 6 pre-filled syringes with safety device EU/1/09/565/030 6 pre-filled syringes with safety needle
Estonian: EU/1/09/565/003 6 süstlit EU/1/09/565/004 6 süstlit, kaitseseadisega EU/1/09/565/030 6 süstlit, turvanõelaga
English: Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe 2 years
Estonian: Biopoin 1000 RÜ/0,5 ml süstelahus süstlis 2 aastat
English: Biopoin 20,000 IU/1 ml injection Epoetin theta
Estonian: Biopoin 20000 RÜ/1 ml süstelahus süstlis Teetaepoetiin
English: The solution is clear and colourless.
Estonian: Süstelahus (süste) süstlis Lahus on läbipaistev ja värvitu.
English: Biopoin 30,000 IU/1 ml injection Epoetin theta
Estonian: Biopoin 30000 RÜ/1 ml süstelahus süstlis Teetaepoetiin
English: Biopoin 1,000 IU/0.5 ml injection Epoetin theta
Estonian: Biopoin 1000 RÜ/0,5 ml süstelahus süstlis Teetaepoetiin
English: Biopoin 5,000 IU/0.5 ml injection Epoetin theta
Estonian: Biopoin 5000 RÜ/0,5 ml süstelahus süstlis Teetaepoetiin
English: Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy Epoetin theta should be administered by the subcutaneous route to patients with anaemia (e.g. haemoglobin concentration ≤ 10 g/dl [6.21 mmol/l]).
Estonian: Aneemiaga patsientidele (hemoglobiini kontsentratsioon ≤10 g/dl [6,21 mmol/l]) tuleb teetaepoetiini manustada subkutaanselt.
English: - The active substance is epoetin theta.
Estonian: Toimeaine on teetaepoetiin
English: EU/1/09/565/002 6 pre-filled syringes with safety device EU/1/09/565/029 6 pre-filled syringes with safety needle
Estonian: EU/1/09/565/001 6 süstlit EU/1/09/565/002 6 süstlit, kaitseseadisega EU/1/09/565/029 6 süstlit, turvanõelaga
English: Non-clinical data with epoetin theta reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Estonian: Farmakoloogilise ohutuse ja korduvtoksilisuse mittekliinilised uuringud ei ole näidanud teetaepoetiini kahjulikku toimet inimesele.
English: Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/565/009
Estonian: Biopoin 5000 RÜ/0,5 ml süstelahus süstlis EU/1/09/565/009
English: Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe 2 years
Estonian: Biopoin 4000 RÜ/0,5 ml süstelahus süstlis 2 aastat
English: EU/1/09/565/010 6 pre-filled syringes with safety device EU/1/09/565/033 6 pre-filled syringes with safety needle
Estonian: EU/1/09/565/009 6 süstlit EU/1/09/565/010 6 süstlit, kaitseseadisega EU/1/09/565/033 6 süstlit, turvanõelaga
English: Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/565/005
Estonian: Biopoin 3000 RÜ/0,5 ml süstelahus süstlis EU/1/09/565/005
English: Biopoin 2,000 IU/0.5 ml
Estonian: Biopoin 2000 RÜ/0,5 ml
English: Biopoin 4,000 IU/0.5 ml injection Epoetin theta
Estonian: Biopoin 4000 RÜ/0,5 ml süstelahus süstlis Teetaepoetiin
English: Biopoin 10,000 IU/1 ml injection Epoetin theta
Estonian: Biopoin 10000 RÜ/1 ml süstelahus süstlis Teetaepoetiin
English: Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe 2 years
Estonian: Biopoin 3000 RÜ/0,5 ml süstelahus süstlis 2 aastat
English: 4 pre-filled syringes with safety device containing 1 ml.
Estonian: 4 1 ml süstlit, kaitseseadisega.
English: Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe 2 years
Estonian: Biopoin 2000 RÜ/0,5 ml süstelahus süstlis 2 aastat
English: EU/1/09/565/006 6 pre-filled syringes with safety device EU/1/09/565/031 6 pre-filled syringes with safety needle
Estonian: EU/1/09/565/005 6 süstlit EU/1/09/565/006 6 süstlit, kaitseseadisega EU/1/09/565/031 6 süstlit, turvanõelaga
English: Biopoin 3,000 IU/0.5 ml injection Epoetin theta
Estonian: Biopoin 3000 RÜ/0,5 ml süstelahus süstlis Teetaepoetiin
English: EU/1/09/565/008 6 pre-filled syringes with safety device EU/1/09/565/032 6 pre-filled syringes with safety needle
Estonian: EU/1/09/565/007 6 süstlit EU/1/09/565/008 6 süstlit, kaitseseadisega EU/1/09/565/032 6 süstlit, turvanõelaga
English: Biopoin 2,000 IU/0.5 ml injection Epoetin theta
Estonian: Biopoin 2000 RÜ/0,5 ml süstelahus süstlis Teetaepoetiin
English: Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/565/003
Estonian: Biopoin 2000 RÜ/0,5 ml süstelahus süstlis EU/1/09/565/003
English: 6 pre-filled syringes with safety device containing 1 ml.
Estonian: 6 1 ml süstlit, kaitseseadisega.
English: If epoetin theta is substituted for another epoetin, the same route of administration should be used.
Estonian: Sama annustamisviisi tuleks kasutada, kui teetaepoetiini asemel kasutatakse mõnda muud epoetiini.
English: Table 1: Adverse reactions System organ class
Estonian: Kõrvaltoimed Organsüsteemi klass Kõrvaltoime
English: Adverse reaction
Estonian: Annustamisviis
English: Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/565/001
Estonian: Biopoin 1000 RÜ/0,5 ml süstelahus süstlis EU/1/09/565/001
English: PRCA caused by neutralising anti-erythropoietin antibodies has been reported in association with erythropoietin therapy, including with epoetin theta.
Estonian: Ravimisel erütropoetiiniga, sh teetaepoetiiniga, on kirjeldatud erütropoetiinivastaste neutraliseerivate antikehade poolt põhjustatud isoleeritud erütrotsütaarset aplaasiat.
English: EU/1/09/565/025 EU/1/09/565/026 EU/1/09/565/027 EU/1/09/565/028 EU/1/09/565/040 EU/1/09/565/041 EU/1/09/565/042
Estonian: EU/1/09/565/037 EU/1/09/565/038 EU/1/09/565/039
English: Preclinical efficacy
Estonian: MANUSTAMISVIIS KÕLBLIKKUSAEG
English: This is expected and may last for a few months.
Estonian: See on ootuspärane ja võib kesta mõne kuu jooksul.
English: • Tell your doctor immediately if you become pregnant.
Estonian: • Teavitage otsekohe oma arsti, kui olete rasestunud.
English: • severe infections throughout the body (sepsis)
Estonian: • rasked infektsioonid kogu kehas (sepsis)
English: Some of these infections have been associated with hospitalisation and death.
Estonian: Mõnedel juhtudel on neid infektsioone seostatud hospitaliseerimise ja surmaga.
English: This means you should tell your doctor if you take other medicines that increase your risk of bleeding.
Estonian: See tähendab, et peate oma arstile ütlema, kui võtate muid ravimeid, mis suurendavad verejooksu riski.
English: The incidence for the 5-year period was 11%.
Estonian: 5-aastase perioodi üldine esinemissagedus oli 11%.
English: It also slows down the worsening of the cancer.
Estonian: See aeglustab ka vähi halvenemist.
English: Patients should be closely monitored.
Estonian: Patsiente tuleb hoolikalt jälgida.
English: Your doctor may adjust your dose.
Estonian: Teie arst võib annust kohandada.
English: Talk to your doctor about what your test results mean.
Estonian: Arutage oma arstiga, mida teie analüüsitulemused tähendavad.
English: The half-life of ibrutinib is 4 to 13 hours.
Estonian: Ibrutiniibi poolväärtusaeg on 4 kuni 13 tundi.
English: Pancreatic findings partially recovered during comparable reversal periods.
Estonian: Pankrease leiud paranesid osaliselt võrreldavate taastumisperioodide jooksul.
English: • if you have high blood pressure
Estonian: • kui teil on kõrge vererõhk;
English: A risk to breast-fed children cannot be excluded.
Estonian: Riski rinnaga toidetavatele lastele ei saa välistada.
English: Total (N=63)
Estonian: Kokku (N = 63)
English: CLL and WM
Estonian: KLL ja WM
English: This does not necessarily mean that your blood cancer is getting worse.
Estonian: See ei tähenda tingimata, et teie verevähk süveneb.
English: Not reached (1.9+, 36.4+)
Estonian: Ei saavutatud (1,9+; 36,4+)
English: The safety and efficacy of IMBRUVICA in children and adolescents aged 0 to 18 years have not been established.
Estonian: IMBRUVICA ohutus ja efektiivsus lastel ja noorukitel vanuses 0 kuni 18 aastat ei ole tõestatud.
English: 48-month follow-up
Estonian: Jälgimine 48 kuu jooksul
English: Your doctor or another healthcare provider may do blood tests to check for TLS.
Estonian: Teie arst või mõni teine tervishoiutöötaja teeb vereanalüüse, et kontrollida teid TLS suhtes.
English: Other medicines and IMBRUVICA
Estonian: Muud ravimid ja IMBRUVICA
English: Final Analysis at 65-month follow-up
Estonian: 65 kuud kestnud jälgimisperioodi lõppanalüüs
English: • if you are planning to have any surgery- your doctor may ask you to stop taking IMBRUVICA for a short time (3 to 7 days) before and after your surgery.
Estonian: • kui teil on planeeritud mis tahes operatsioon - teie arst võib paluda teil katkestada IMBRUVICA võtmise lühikeseks ajaks (3 kuni 7 päeva) enne ja pärast operatsiooni;
English: • inflammation within the lungs that may lead to permanent damage
Estonian: • põletik kopsudes, mis võib põhjustada püsivat kahjustust
English: Frequency (All grades)
Estonian: Esinemissagedus (kõik astmed)
English: The study enrolled 269 patients with CLL.
Estonian: Uuringus osales 269 patsienti, kellel oli KLL.
English: ORR (%) p-value p<0.0001
Estonian: ORR (%) p-väärtus p < 0,0001
English: Spontaneous reports from post-marketing experience.
Estonian: Turuletulekujärgsed spontaansed teatised.
English: • The active substance is ibrutinib.
Estonian: • Toimeaine on ibrutiniib.
English: It belongs to a class of medicines called protein kinase inhibitors.
Estonian: See kuulub ravimiklassi, mida nimetatakse proteiini kinaasi inhibiitoriteks.
English: This is because it can increase the amount of IMBRUVICA in your blood.
Estonian: See on vajalik, kuna need võivad suurendada IMBRUVICA kogust teie veres.
English: The mechanism for the bleeding-related events is not fully understood.
Estonian: Veritsustega seotud kõrvaltoimete mehhanism ei ole täielikult selge.
English: This is because IMBRUVICA may affect the way some other medicines work.
Estonian: See on vajalik, kuna IMBRUVICA võib mõjutada viisi, kuidas mõned teised ravimid toimivad.