natgillin/translations-raw huggingface dataset:
Olanzapine Teva 5 mg smeltetabletter 
Olanzapine Teva 5 mg orodispersible tablets
Olanzapine Teva 5 mg smeltetabletter Olanzapin 
NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 5 mg orodispersible tablets Olanzapine
28 filmovertrukne tabletter 28 x 1 filmovertrukne tabletter 30 filmovertrukne tabletter 30 x 1 filmovertrukne tabletter 35 filmovertrukne tabletter 35 x 1 filmovertrukne tabletter 56 filmovertrukne tabletter 56 x 1 filmovertrukne tabletter 60 filmovertrukne tabletter 70 filmovertrukne tabletter 70 x 1 filmovertrukne tabletter 98 filmovertrukne tabletter 98 x 1 filmovertrukne tabletter 
28 film-coated tablets 28 x 1 film-coated tablets 30 film-coated tablets 30 x 1 film-coated tablets 35 film-coated tablets 35 x 1 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 60 film-coated tablets 70 film-coated tablets 70 x 1 film-coated tablets 98 film-coated tablets 98 x 1 film-coated tablets
Olanzapine Teva 5 mg filmovertrukket tablet er en hvid, bikonveks, rund filmovertrukket tablet, præget med ”OL 5” på den ene side og glat på den anden side. 
Olanzapine Teva 5 mg film-coated tablet is a white, biconvex, round film-coated tablet, debossed ”OL 5” on one side and plain on the other.
Hver filmovertrukket tablet indeholder: 7,5 mg olanzapin. 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: 7.5 mg Olanzapine.
EU/1/07/427/022 - 56 tabletter pr. karton. 
EU/1/07/427/022 - 56 tablets, per box
Olanzapine Teva 5 mg filmovertrukne tabletter fås i kartoner med 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 70, 70 x 1, 98 eller 98 x 1 filmovertrukne tabletter. 
Olanzapine Teva 5 mg film-coated tablets are available in cartons of 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 70, 70 x 1, 98 or 98 x 1 film-coated tablets.
EU/1/07/427/058 - 98 tabletter pr. karton. 
EU/1/07/427/058 - 98 tablets, per box
EU/1/07/427/019 - 56 tabletter pr. karton. 
EU/1/07/427/019 - 56 tablets, per box
Olanzapine Teva 5 mg smeltetablet er en gul, rund, bikonveks tablet med en diameter på 8 mm. Olanzapine Teva 10 mg smeltetablet er en gul, rund, bikonveks tablet med en diameter på 10 mm. 
Olanzapine Teva 5 mg orodispersible tablets A yellow, round, biconvex tablet, with 8 mm of diameter.
Olanzapine Teva 10 mg filmovertrukne tabletter fås i kartoner med 7, 7 x 1, 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 eller 98 x 1 filmovertrukne tabletter. 
Olanzapine Teva 10 mg film-coated tablets are available in cartons of 7, 7 x 1, 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 or 98 x1 film-coated tablets.
Olanzapine Teva 10 mg smeltetabletter Olanzapin 
NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 10 mg orodispersible tablets Olanzapine
EU/1/07/427/002 - 30 tabletter pr. karton. 
EU/1/07/427/002 - 30 tablets, per box
EU/1/07/427/033 - 50 tabletter pr. karton. 
EU/1/07/427/033 - 50 tablets, per box
Olanzapine Teva 15 mg smeltetabletter Olanzapin 
NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 15 mg orodispersible tablets Olanzapine
EU/1/07/427/021 - 30 tabletter pr. karton. 
EU/1/07/427/021 - 30 tablets, per box
EU/1/07/427/038 - 35 tabletter pr. karton. 
EU/1/07/427/038 - 35 tablets, per box
Olanzapine Teva 15 mg smeltetablet er en gul, rund, bikonveks tablet med en diameter på 11 mm. Olanzapine Teva 20 mg smeltetablet er en gul, rund, bikonveks tablet med en diameter på 12 mm. 
Olanzapine Teva 15 mg orodispersible tablet is a yellow, round, biconvex tablet, with 11 mm of diameter.
Olanzapine Teva 15 mg smeltetabletter 
Olanzapine Teva 15 mg orodispersible tablets
EU/1/07/427/034 - 56 tabletter pr. karton. 
EU/1/07/427/034 - 56 tablets, per box
EU/1/07/427/026 - 56 tabletter pr. karton. 
EU/1/07/427/026 - 56 tablets, per box
Ændring i fastende triglyceridniveau fra let forhøjet niveau ved baseline (≥ 1,69 - < 2,26 mmol/l) til højt niveau (≥ 2,26 mmol/l) var meget almindeligt. 
(≥1.69 mmol/l-<2.26 mmol/l) to high (≥2.26 mmol/l) were very common.
EU/1/07/427/018 - 50 tabletter pr. karton. 
EU/1/07/427/018 - 50 tablets, per box
EU/1/07/427/053 - 70 tabletter pr. karton. 
EU/1/07/427/053 - 70 tablets, per box
OPA/Aluminium/PVC-Aluminium blister i kartoner a 7, 7 x 1, 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 eller 98 x 1 filmovertrukne tabletter pr. karton. 
OPA/alu/PVC-alu blisters in cartons of 7, 7 x 1, 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 or 98 x 1 film-coated tablets per carton.
Høje niveauer af 
High Gamma
Olanzapine Teva 7,5 mg filmovertrukne tabletter fås i kartoner med 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 eller 98 x 1 filmovertrukne tabletter. 
Olanzapine Teva 7.5 mg film-coated tablets are available in cartons of 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 or 98 x 1 film-coated tablets.
EU/1/07/427/003 - 56 tabletter pr. karton. 
EU/1/07/427/003 - 56 tablets, per box
EU/1/07/427/055 - 70 tabletter pr. karton. 
EU/1/07/427/055 - 70 tablets, per box
EU/1/07/427/024 - 30 tabletter pr. karton. 
EU/1/07/427/024 - 30 tablets, per box
EU/1/07/427/063 - 98 tabletter pr. karton. 
EU/1/07/427/063 - 98 tablets, per box
EU/1/07/427/056 - 70 tabletter pr. karton. 
EU/1/07/427/056 - 70 tablets, per box
EU/1/07/427/054 - 70 tabletter pr. karton. 
EU/1/07/427/054 - 70 tablets, per box
EU/1/07/427/030 - 56 tabletter pr. karton. 
EU/1/07/427/030 - 56 tablets, per box
OPA/Aluminium/PVC-Aluminium blister i kartoner a 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 eller 98 x 1 filmovertrukne tabletter pr. karton. 
OPA/alu/PVC-alu blisters in cartons of 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 or 98 x 1 film-coated tablets per carton.
OPA/Aluminium/PVC-Aluminium blister i kartoner a 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 70, 70 x 1, 98 eller 98 x 1 filmovertrukne tabletter pr. karton. 
OPA/alu/PVC-alu blisters in cartons of 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 70, 70 x 1, 98 or 98 x 1 film-coated tablets per carton.
Vægtøgning1 
Neutropenia10
EU/1/07/427/044 - 35 tabletter pr. karton. 
EU/1/07/427/044 - 35 tablets, per box
Tabletovertræk 
Orodispersible tablet
EU/1/07/427/025 - 50 tabletter pr. karton. 
EU/1/07/427/025 - 50 tablets, per box
EU/1/07/427/032 - 30 tabletter pr. karton. 
EU/1/07/427/032 - 30 tablets, per box
Hver filmovertrukket tablet indeholder: 2,5 mg olanzapin. 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: 2.5 mg Olanzapine.
EU/1/07/427/046 - 35 tabletter pr. karton. 
EU/1/07/427/046 - 35 tablets, per box
EU/1/07/427/066 - 98 tabletter pr. karton. 
EU/1/07/427/066 - 98 tablets, per box
EU/1/07/427/037 - 56 tabletter pr. karton. 
EU/1/07/427/037 - 56 tablets, per box
EU/1/07/427/042 - 35 tabletter pr. karton. 
EU/1/07/427/042 - 35 tablets, per box
EU/1/07/427/065 - 98 tabletter pr. karton. 
EU/1/07/427/065 - 98 tablets, per box
Olanzapine Teva 15 mg smeltetabletter OPA-Al-PVC/Al blister i kartoner a 28, 30, 35, 50, 56, 70 eller 98 smeltetabletter pr. karton. 
Olanzapine Teva 15 mg film-coated tablets OPA/alu/PVC-alu blisters in cartons of 28, 30, 35, 50, 56, 70 or 98 film-coated tablets per carton.
EU/1/07/427/064 - 98 tabletter pr. karton. 
EU/1/07/427/064 - 98 tablets, per box
EU/1/07/427/057 - 70 tabletter pr. karton. 
EU/1/07/427/057 - 70 tablets, per box
EU/1/07/427/043 - 35 tabletter pr. karton. 
EU/1/07/427/043 - 35 tablets, per box
28 smeltetabletter 30 smeltetabletter 35 smeltetabletter 50 smeltetabletter 56 smeltetabletter 70 smeltetabletter 98 smeltetabletter 
28 orodispersible tablets 30 orodispersible tablets 35 orodispersible tablets 50 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets 98 orodispersible tablets
28 smeltetabletter 30 smeltetabletter 35 smeltetabletter 56 smeltetabletter 70 smeltetabletter 98 smeltetabletter 
28 orodispersible tablets 30 orodispersible tablets 35 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets 98 orodispersible tablets
Olanzapine Teva 2,5 mg filmovertrukne tabletter Olanzapin 
NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 2.5 mg film-coated tablets Olanzapine
EU/1/07/427/067 - 98 tabletter pr. karton. 
EU/1/07/427/067 - 98 tablets, per box
EU/1/07/427/045 - 35 tabletter pr. karton. 
EU/1/07/427/045 - 35 tablets, per box
Hver filmovertrukket tablet indeholder: 20 mg olanzapin. 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: 20 mg Olanzapine.
EU/1/07/427/040 - 35 tabletter pr. karton. 
EU/1/07/427/047 - 35 tablets, per box
OPA/Aluminium/PVC-Aluminium blister i kartoner a 28, 30, 35, 50, 56, 70 eller 98 filmovertrukne tabletter pr. karton. 
OPA-Al-PVC/Al blisters in cartons of 28, 30, 35, 50, 56, 70 or 98 orodispersible tablets per carton.
Storbritannien 8y 
United Kingdom 8y
Tyskland Faktor VIII Sdh Intersero 
Germany Faktor VIII Sdh Intersero
Storbritannien Optivate 
United Kingdom Optivate
Storbritannien Alphanate 
United Kingdom Alphanate
Grækenland Haemoctin Vianex S.A. 
Haemoctin Vianex S.A.
Storbritannien Fanhdi 
United Kingdom Fanhdi
Storbritannien Wilate 
United Kingdom Wilate
Storbritannien Octanate 
United Kingdom Octanate
Haemoctin Biotest Hungaria Kft. Human koagulationsfaktor VIII 
Haemoctin Biotest Hungaria Kft. Human Coagulation Factor VIII
Von Willebrand-faktor 
Human Von Willebrand Factor
Pulver og solvens til infusionsvæske, opløsning 
Powder And Solvent For Solution For Infusion
Pulver til injektionsvæske 
Powder For Solution For Injection
Octapharma-Ltd Human koagulationsfaktor VIII 
Octapharma-Ltd Human Coagulation Factor VIII
Instituto Grifols, S.A. Human koagulationsfaktor VIII 
Instituto Grifols, S.A. Human Coagulation Factor VIII
Storbritannien Octanate Lv Octapharma-Ltd Human koagulationsfaktor VIII 
United Kingdom Octanate Lv Octapharma-Ltd Human Coagulation Factor VIII
LFB Biomedicaments Human koagulationsfaktor VIII 
LFB Biomedicaments Human Coagulation Factor VIII
Human koagulationsfaktor VIII (rDNA) 66,6 IE /ml, Human Von 
Human Coagulation Factor VIII (Rdna) 66.6 I.U.
Octapharma France Human koagulationsfaktor VIII 
Octapharma France Human Coagulation Factor VIII
Grækenland Octanate 
Belgium Octanate
Instituto Grifols, S.A. Human koagulationsfaktor VIII, Von Willebrand-faktor 
Instituto Grifols, S.A. Human Coagulation Factor VIII, Human Von Willebrand Factor
Grækenland Wilate 
Belgium Wilate
Octanate LV Octapharma France Human koagulationsfaktor VIII 
Octanate LV Octapharma France Human Coagulation Factor VIII
Intersero Gmbh Human koagulationsfaktor VIII 
Intersero Gmbh Human Coagulation Factor VIII
Human koagulationsfaktor VIII 100 IE/ml, Human Von Willebrand-faktor 100 IE/ml VIII 
Human Coagulation Factor VIII 100 I.U./ml, Human Von Willebrand Factor 100 I.U./ml VIII
Grifols Italia S.P.A Human koagulationsfaktor VIII, Human Von 
Grifols Italia S.P.A Human Coagulation Factor VIII, Human Von Willebrand Factor
Octapharma Ab Human koagulationsfaktor VIII 
Octapharma Ab Human Coagulation Factor VIII
Human koagulationsfaktor VIII 1.000 IE 
Human Coagulation Factor VIII 1000 IU
Instituto Grifols, S.A. Human koagulationsfaktor VIII, Human Von 
Instituto Grifols, S.A. Human Coagulation Factor VIII, Von
Csl Behring Gmbh Human koagulationsfaktor VIII (rDNA), Human Von Willebrand-faktor 
Csl Behring Gmbh Human Coagulation Factor VIII, Human Von Willebrand Factor
Storbritannien Haemoctin Biotest Pharma Gmbh 
United Kingdom Haemoctin Biotest Pharma Gmbh
Octapharma Gmbh Human koagulationsfaktor VIII 
Octapharma Gmbh Human Coagulation Factor VIII
Octanate Lv Octapharma Ab Human koagulationsfaktor VIII 
Octanate Lv Octapharma Ab Human Coagulation Factor VIII
Octanate 1000 Octapharma Gmbh Human koagulationsfaktor VIII 
Octanate 1000 Octapharma Gmbh Human Coagulation Factor VIII
Human koagulationsfaktor VIII 250 IE 
Human Coagulation Factor VIII 250 I.E.
Grækenland Fanhdi 
Czech Republic Fanhdi
Octanate 250 Octapharma Gmbh Human koagulationsfaktor VIII 
Octanate 250 Octapharma Gmbh Human Coagulation Factor VIII
Human koagulationsfaktor VIII 500 IE, Human Von Willebrand-faktor 300 IE. 
Human Coagulation Factor VIII 500 I.E., Human Von Willebrand Factor 300 I.E.
Human koagulationsfaktor VIII 1.000 IE, Human Von Willebrand-faktor 2.400 IE. 
Human Coagulation Factor VIII 1000 I.E. Human Von Willebrand Factor 2400 I.E.
Wilate 450 Octapharma Gmbh Human koagulationsfaktor VIII, 
Wilate 450 Octapharma Gmbh Human Coagulation Factor VIII, Human Von
Human koagulationsfaktor VIII 250 IE, Human Von Willebrand-faktor 600 IE. 
Human Coagulation Factor VIII 250 I.E., Human Von Willebrand Factor 600 I.E.
Haemate P Csl Behring, S.A Human koagulationsfaktor VIII, 
Haemate P Csl Behring, S.A Human Coagulation Factor VIII, Von
Human koagulationsfaktor VIII 500 IE, Human Von Willebrand-faktor 1.200 IE. 
Human Coagulation Factor VIII 500 I.E., Human Von Willebrand Factor 1200 I.E.
Beriate 2000 Csl Behring Gmbh Human koagulationsfaktor VIII 
Beriate 2000 Csl Behring Gmbh Human Coagulation Factor VIII
Beriate 500 Csl Behring Gmbh Human koagulationsfaktor VIII 
Beriate 500 Csl Behring Gmbh Human Coagulation Factor VIII
Octanate 500 Octapharma Gmbh Human koagulationsfaktor VIII 
Octanate 500 Octapharma Gmbh Human Coagulation Factor VIII
Wilate 900 Octapharma Gmbh Human koagulationsfaktor VIII, 
Wilate 900 Octapharma Gmbh Human Coagulation Factor VIII, Human Von
Beriate 250 Csl Behring Gmbh Human koagulationsfaktor VIII 
Beriate 250 Csl Behring Gmbh Human Coagulation Factor VIII
Octanate Lv Octapharma Gmbh Human koagulationsfaktor VIII 
Octanate Lv Octapharma Gmbh Human Coagulation Factor VIII
Human koagulationsfaktor VIII (rDNA) 1.000 IE /10 ml 
Human Coagulation Factor VIII (Rdna) 1000IU/Vial
Beriate 1000 Csl Behring Gmbh Human koagulationsfaktor VIII 
Beriate 1000 Csl Behring Gmbh Human Coagulation Factor VIII
Human koagulationsfaktor VIII 1.000 IE, Human Von Willebrand-faktor 600 IE 
Human Coagulation Factor VIII 1000 I.E./ Human Von Willebrand Factor 600 I.E.
Csl Behring Gmbh Human koagulationsfaktor VIII 
Csl Behring Gmbh Human Coagulation Factor VIII
Human koagulationsfaktor VIII 500 IE 
Human Coagulation Factor VIII 500 IU
Human koagulationsfaktor VIII 50 IE /ml, Von Willebrand-faktor 120 IE /ml 
Human Coagulation Factor VIII 500IU/Vial, Human Von Willebrand Factor 120 I.U.
Human koagulationsfaktor VIII 250 IE, Human Von Willebrand-faktor 150 IE. 
Human Coagulation Factor VIII 250 I.E. Human Von Willebrand Factor 150 I.E.
Wilate 500 Octapharma Gmbh Human koagulationsfaktor VIII, 
Wilate 500 Octapharma Gmbh Human Coagulation Factor VIII, Human Von
Wilate 1000 Octapharma Gmbh Human koagulationsfaktor VIII, 
Wilate 1000 Octapharma Gmbh Human Coagulation Factor VIII, Human Von
Human koagulationsfaktor VIII (rDNA) 200 IE /ml 
Human Coagulation Factor VIII (Rdna) 200 I.U.
Luxembourg Haemate P Csl Behring Gmbh Human koagulationsfaktor VIII, 
Luxembourg Haemate P Csl Behring Gmbh Human Coagulation Factor VIII, Human Von
Human koagulationsfaktor VIII 500 IE. 
Human Coagulation Factor VIII 500 I.U.
Human koagulationsfaktor VIII (rDNA) 500 IE /5 ml 
Human Coagulation Factor VIII (Rdna) 500IU/Vial
Octapharma Ab Human koagulationsfaktor VIII, Human Von 
Octapharma Ab Human Coagulation Factor VIII, Human Von Willebrand Factor
Human koagulationsfaktor VIII 1.500 IE 
Human Coagulation Factor VIII 1500 I.E.
Human koagulationsfaktor VIII (rDNA) 100 IE /ml 
Human Coagulation Factor VIII (Rdna) 100 I.U.
Octapharma-Ltd Human koagulationsfaktor VIII, Human Von 
Octapharma-Ltd Human Coagulation Factor VIII, Human Von Willebrand Factor
Human koagulationsfaktor VIII 2.000 IE 
Human Coagulation Factor VIII 2000 IU
Storbritannien Haemate P Csl Behring Gmbh Human koagulationsfaktor VIII, 
United Kingdom Haemate P Csl Behring Gmbh Human Coagulation Factor VIII, Human Von
Human koagulationsfaktor VIII (rDNA) 25 IE /ml 
Human Coagulation Factor VIII (Rdna) 25 I.U.
Human koagulationsfaktor VIII 100 IE /ml, Von Willebrand-faktor 25 IE /ml 
Human Coagulation Factor VIII 100 I.U./ml, Human Von Willebrand Factor 100 I.U./mlVIII
Grækenland Recombinate Baxalta Innovations GmbH 
Belgium Recombinate Baxalta Innovations Gmbh
Human koagulationsfaktor VIII 500 IE/hætteglas, Human Von 
Human Coagulation Factor VIII 500IU/Vial
Human koagulationsfaktor VIII (rDNA) 50 IE /ml 
Human Coagulation Factor VIII (Rdna) 50 I.U.
Human koagulationsfaktor VIII 1.000 IE /10 ml Human Von 
Human Coagulation Factor VIII 1000IU/Vial
Willebrand-faktor 75 IE /ml 
/ ml, Von Willebrand Factor 25 I.U.
Human koagulationsfaktor VIII (rDNA) 250 IE /5 ml 
Human Coagulation Factor VIII (Rdna) 250IU/Vial
Haemate P Csl Behring Gmbh Human koagulationsfaktor VIII (rDNA), Human Von 
Haemate P Csl Behring Gmbh Human Coagulation Factor VIII, Human Von
Human koagulationsfaktor VIII 250 IE /2,5 ml Human Von 
Human Coagulation Factor VIII 250IU/Vial
Haemate P CSL Behring Gmbh Human koagulationsfaktor VIII, 
Haemate P CSL Behring Gmbh Human Coagulation Factor VIII Human Von
Human koagulationsfaktor VIII (rDNA) 500 IE Hætteglas 
Human Coagulation Factor VIII (Rdna) 500 I.U.
Octapharma Gmbh Human koagulationsfaktor VIII, Human Von 
Octapharma Gmbh Human Coagulation Factor VIII, Human Von Willebrand Factor
Grækenland Haemate P Csl Behring Mepe Human koagulationsfaktor VIII, 
Haemate P Csl Behring Mepe Human Coagulation Factor VIII, Human Von
500 IE/hætteglas 
/ 5 ml
Human koagulationsfaktor VIII (rDNA) 1.000 IE Hætteglas 
Human Coagulation Factor VIII (Rdna) 1000 I.U.
Human koagulationsfaktor VIII (rDNA) 250 IE Hætteglas 
Human Coagulation Factor VIII (Rdna) 250 I.U.
Dato for første markedsføringstilladelse: 24. juni 2016 
Date of first authorisation: 24 June 2016
Der er ingen kendt specifik antidot. 
There is no known specific antidote.
HDPE-flasker: 3 år Blistre: 5 år 
HDPE bottles: 3 years Blisters: 5 years
Størrelsen af denne effekt betragtes ikke som klinisk relevant. 
The magnitude of this effect is not considered to be of clinical relevance.
Kapslerne er pakket i flasker eller blistre. 
The capsules are packaged in bottles or blisters.
Børn og unge under 18 år må ikke tage dette lægemiddel, da det ikke er blevet undersøgt hos denne aldersgruppe. 
Children and adolescents under the age of 18 years must not take this medicine as it has not been studied in these age groups.
Det kan generelt konkluderes, at nyrerne ikke er den primære udskillelsesvej. 
Overall, it can be concluded that the kidney is not the primary route of excretion.
Der skal udvises forsigtighed hos patienter ≥ 85 år, da der er begrænset erfaring med denne aldersgruppe. 
Caution must be exercised in patients ≥ 85 years of age as there is limited experience in this age group.
Det vil gøre det nemmere for lægen at finde ud af, hvad du har taget. 
This will help the doctor identify what you have taken.
Dyskinesier var den hyppigst rapporterede behandlingsrelaterede bivirkning (17,7 %). 
Dyskinesia was the most frequently reported treatment-emergent adverse reaction (17.7%).
Selvom den embryo-føtale udvikling ikke var negativt påvirket hos kaniner, betragtes studiet ikke som prædiktivt for human risikovurdering. 
Although embryo-foetal development was not negatively influenced in rabbits, the study is not considered predictive for human risk assessment.
Lægemidler, der metaboliseres af COMT 
Medicinal products metabolised by COMT
Bemærk: En respondent var en patient, som havde en reduktion i samlet OFF-tid på mindst 1 time (OFFtidsrespondent) 
Note: A responder was a patient who had a reduction of at least 1 hour in absolute OFF-time (OFF-time responder)
Kapslerne skal sluges hele med vand. 
The capsules should be swallowed whole with water.
Der skal administreres relevant symptomatisk og understøttende behandling. 
Symptomatic and supportive treatment should be administered as appropriate.
Ældre (≤ 65 år) 
Elderly (≥ 65 years old)
Den anbefalede dosis er 50 mg én gang dagligt. 
The recommended dose is 50 mg once daily.
Du skal så hurtigt som muligt fortælle din læge, hvis du bliver opmærksom på nogle af følgende bivirkninger: 
Tell your doctor as soon as possible if you notice any of the following side effects:
Der er ingen eller utilstrækkelige data fra anvendelse af opicapon til gravide kvinder. 
There are no or limited amount of data from the use of opicapone in pregnant women.
Ved screening var gennemsnitsalderen ens i alle behandlingsgrupper i de to studier og lå i intervallet 61,5 og 65,3 år. 
At screening, the mean age was similar in all treatment groups in both studies, ranging between 61.5 and 65.3 years.
Tag Ongentys mindst én time før eller efter, du tager din levodopa-medicin. 
Take Ongentys at least one hour before or after taking your levodopa medicine.
Meget almindelig: kan forekomme hos flere end 1 ud af 10 patienter - ufrivillige og ukontrollerbare bevægelser eller svært ved at bevæge kroppen eller smertefulde bevægelser 
Very common: may affect more than 1 in 10 people - involuntary and uncontrollable, or difficult or painful body movements
Alle reduktioner i aktivitet forekom i det væsentlige ved den højeste koncentration af opicapon (10 mikrog/ml). 
All reductions in activity essentially occurred at the highest concentration of opicapone (10 mcg/mL).
Bivirkninger forårsaget af Ongentys er ofte lette til moderate og opstår for det meste inden for de første uger af behandlingen. 
Side effects caused by Ongentys are usually mild to moderate and occur mostly within the first weeks of treatment.
Selvom der ikke er evidens for, at hverken opicapons virkning eller sikkerhed påvirkes af levodopapræparater med kontrolleret frigivelse, er erfaringen med sådanne præparater begrænset. 
Although there is no evidence that either the efficacy or safety of opicapone would be affected by use of controlled-release levodopa preparations, the experience with such preparations is limited.
Hyppigheden er defineret på følgende måde: meget almindelig (≥ 1/10), almindelig (≤ 1/100 til < 1/10), ikke almindelig (≤ 1/1.000 til < 1/100), sjælden (≤ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Du må ikke stoppe med at tage Ongentys, medmindre du har fået besked på det af lægen, da dine symptomer kan blive værre. 
Do not stop taking Ongentys unless your doctor tells you to as your symptoms may get worse.
Kontakt straks din læge, hvis du får bivirkninger i starten af behandlingen. 
Contact your doctor straight away if you experience any side effects at the start of treatment.
Andre metaboliseringsveje inkluderer glukuronidering, metylering og reduktion. 
Other metabolic pathways include glucuronidation, methylation and reduction.
Synk kapslen hel med et glas vand til. 
Swallow the capsule whole with a glass of water.
Tabel 2 - Ændring i samlet OFF-tid og ON-tid (minutter) fra baseline til endepunkt Behandling 
Table 2 - Change in absolute OFF-time and ON-time (minutes) from baseline to endpoint Treatment
Derfor skal de forsigtighedsregler, der gælder for levodopa, ligeledes tages i betragtning for Ongentys. 
Hence, the precautions valid for levodopa treatment should also be taken into account for Ongentys.
Der bør derfor udvises forsigtighed, når der føres motorkøretøj eller betjenes maskiner. 
Therefore, caution should be exercised when driving or using machines.
Ændring i samlet ON-tid uden generende dyskinesiera 
Change in total ON-time without troublesome dyskinesiasa
Dysgeusi, hyperkinesi, synkope 
Dysgeusia, Hyperkinesia, Syncope
Den resterende radioaktivitet blev udskilt i urin (gennemsnit 12,8 %) og via udåndingsluften (gennemsnit 15,9 %). 
The remainder of the radioactivity was excreted in urine (mean 12.8%) and via expired air (mean 15.9%).
Det er derfor ofte nødvendigt at justere levodopadosis inden for de første dage til uger efter påbegyndelse af opicapon-behandling (se pkt. 
Hence, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating the treatment with opicapone (see section 4.4).