FrancophonIA/ELRC3.0 huggingface dataset:
English: Olanzapine Teva 2.5 mg film-coated tablets are available in cartons of 28, 30, 35, 56, 70 or 98 filmcoated tablets.
Swedish: Olanzapine Teva 2,5 mg filmdragerade tabletter tillhandahålls i förpackningar med 28, 30, 35, 56, 70 eller 98 tabletter.
English: OPA-Al-PVC/Al blisters in cartons of 28, 30, 35, 56, 70 or 98 orodispersible tablets per carton.
Swedish: OPA/Aluminium/PVC-aluminium-blisterförpackningar i kartonger om 28, 30, 35, 56, 70 eller 98 munlösliga tabletter per kartong.
English: Olanzapine Teva 10 mg film-coated tablet is a white, biconvex, round film-coated tablet, debossed ”OL 10” on one side and plain on the other.
Swedish: Olanzapine Teva 10 mg filmdragerade tabletter är vita, bikonvexa, runda, filmdragerade tabletter, präglade med ”OL 10” på en sida och omärkta på den andra.
English: 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
Swedish: 28 filmdragerade tabletter 28 x 1 filmdragerade tabletter 30 filmdragerade tabletter 30 x 1 filmdragerade tabletter 35 ilmdragerade tabletter 35 x 1 filmdragerade tabletter 56 filmdragerade tabletter 56 x 1 filmdragerade tabletter 60 filmdragerade tabletter 70 filmdragerade tabletter 70 x 1 filmdragerade tabletter 98 filmdragerade tabletter 98 x 1> filmdragerade tabletter
English: Olanzapine
Swedish: Glykosuri
English: Elevated cholesterol levels2,3
Swedish: Metabolism och nutrition Viktuppgång1 Förhöjd kolesterolnivå2, 3
English: INFORMATION IN BRAILLE Olanzapine Teva 5 mg film-coated tablets
Swedish: INFORMATION I PUNKTSKRIFT Olanzapine Teva 5 mg filmdragerade tabletter
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 15 mg orodispersible tablets Olanzapine
Swedish: LÄKEMEDLETS NAMN Olanzapine Teva 15 mg munlösliga tabletter olanzapin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains: 10 mg Olanzapine.
Swedish: DEKLARATION AV AKTIV(A) SUBSTANS(ER) 1 tablett innehåller: Olanzapin 10 mg.
English: 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.
Swedish: Olanzapine Teva 5 mg filmdragerade tabletter är vita, bikonvexa, runda, filmdragerade tabletter, präglade med ”OL 5” på en sida och omärkta på den andra.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 5 mg orodispersible tablets Olanzapine
Swedish: LÄKEMEDLETS NAMN Olanzapine Teva 5 mg munlösliga tabletter olanzapin
English: 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 50 film-coated tablets 50 x 1 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 70 film-coated tablets 70 x 1 film-coated tablets 98 film-coated tablets 98 x 1 film-coated tablets
Swedish: 28 filmdragerade tabletter 28 x 1 filmdragerade tabletter 30 filmdragerade tabletter 30 x 1 filmdragerade tabletter 35 filmdragerade tabletter 35 x 1 filmdragerade tabletter 50 filmdragerade tabletter 50 x 1 filmdragerade tabletter 56 filmdragerade tabletter 56 x 1 filmdragerade tabletter 70 filmdragerade tabletter 70 x 1 filmdragerade tabletter 90 filmdragerade tabletter 90 x 1 filmdragerade tabletter
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 10 mg film-coated tablets Olanzapine
Swedish: LÄKEMEDLETS NAMN Olanzapine Teva 10 mg filmdragerade tabletter olanzapin
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 15 mg film-coated tablets Olanzapine
Swedish: LÄKEMEDLETS NAMN Olanzapine Teva 15 mg filmdragerade tabletter olanzapin
English: 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.
Swedish: Olanzapine Teva 5 mg filmdragerade tabletter tillhandahålls i förpackningar 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 tabletter.
English: 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.
Swedish: Olanzapine Teva 10 mg filmdragerade tabletter tillhandahålls i förpackningar 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 tabletter.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains: 5 mg Olanzapine.
Swedish: DEKLARATION AV AKTIV(A) SUBSTANS(ER) 1 tablett innehåller: Olanzapin 5 mg.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 5 mg film-coated tablets Olanzapine
Swedish: LÄKEMEDLETS NAMN Olanzapine Teva 5 mg filmdragerade tabletter olanzapin
English: 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.
Swedish: OPA/Aluminium/PVC-aluminium-blisterförpackningar i kartonger om 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 filmdragerade tabletter per kartong.
English: 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.
Swedish: OPA/Aluminium/PVC-aluminium-blisterförpackningar i kartonger om 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 filmdragerade tabletter per kartong.
English: 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.
Swedish: OPA/Aluminium/PVC-aluminium-blisterförpackningar i kartonger om 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 filmdragerade tabletter per kartong.
English: What you need to know before you take Olanzapine Teva 3.
Swedish: Vad Olanzapine Teva är och vad det används för Vad du behöver veta innan du tar Olanzapine Teva Hur du tar Olanzapine Teva Eventuella biverkningar
English: 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.
Swedish: Olanzapine Teva 7,5 mg filmdragerade tabletter tillhandahålls i förpackningar 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 tabletter.
English: Olanzapine Teva 20 mg film-coated tablets are available in cartons of 28, 30, 35, 56, 70 or 98 filmcoated tablets.
Swedish: Olanzapine Teva 20 mg filmdragerade tabletter tillhandahålls i förpackningar med 28, 30, 35, 56, 70 eller 98 tabletter.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains: 15 mg Olanzapine.
Swedish: DEKLARATION AV AKTIV(A) SUBSTANS(ER) 1 tablett innehåller: Olanzapin 15 mg.
English: Olanzapine Teva 2.5 mg film-coated tablets White, biconvex, round film-coated tablets, debossed ”OL 2.5” on one side and plain on the other.
Swedish: Läkemedlets utseende och förpackningsstorlekar Olanzapine Teva 2,5 mg filmdragerade tabletter är vita, bikonvexa, runda, filmdragerade tabletter, präglade med ”OL 2.5” på en sida och omärkta på den andra.
English: 14 Observed for fasting normal levels at baseline (<1.016 mmol/l) which increased to high
Swedish: 14 Normala värden (<1,016 mmol/l) vid fasta vid studiens början ökade till höga (≥1,467 mmol/l).
English: Glucosuria Increased appetite
Swedish: Ökad aptit
English: Annex I List of medicinal products and presentations
Swedish: Bilaga I Lista över läkemedel och beredningsformer
English: Czech Republic Immunate Stim Plus
Swedish: Immunate Stim Plus
English: Germany Faktor VIII Sdh Intersero
Swedish: Tyskland Faktor VIII Sdh Intersero
English: Willebrand Factor
Swedish: Willebrand-faktor
English: Belgium Factane 500 IU - 5 ml
Swedish: Factane 500 IE - 5 ml
English: Belgium Haemate P2400-1000
Swedish: Haemate P2400-1000
English: Belgium Factane 1000 IU/10 ml
Swedish: Factane 1 000 IE/10 ml
English: Belgium Haemate P1200-500
Swedish: Haemate P1200-500
English: Belgium Haemate P600-250
Swedish: Haemate P600-250
English: United Kingdom Alphanate
Swedish: Nederländerna Alphanate
English: Haemoctin Biotest Hungaria Kft. Human Coagulation Factor VIII
Swedish: Haemoctin Biotest Hungaria Kft. Human koagulationsfaktor VIII
English: Czech Republic Optivate
Swedish: Nederländerna Optivate
English: Belgium Wilate
Swedish: Nederländerna Wilate
English: Belgium Octanate
Swedish: Nederländerna Octanate
English: Instituto Grifols, S.A. Human Coagulation Factor VIII
Swedish: Instituto Grifols, S.A. Human koagulationsfaktor VIII
English: Octapharma-Ltd Human Coagulation Factor VIII
Swedish: Octapharma-Ltd Human koagulationsfaktor VIII
English: Powder For Injection Intravenous Use
Swedish: Pulver till injektionsvätska
English: Lfb Biomedicaments Human Coagulation Factor VIII
Swedish: LFB Biomedicaments Human koagulationsfaktor VIII
English: LFB Biomedicaments Human Coagulation Factor VIII
Swedish: Lfb Biomedicaments Human koagulationsfaktor VIII
English: Grifols Italia S.P.A Human Coagulation Factor VIII, Human Von Willebrand Factor
Swedish: Grifols Italia S.P.A Human koagulationsfaktor VIII, human von Willebrandfaktor
English: Octapharma France Human Coagulation Factor VIII
Swedish: Octapharma France Human koagulationsfaktor VIII
English: Octanate LV Octapharma France Human Coagulation Factor VIII
Swedish: Octanate LV Octapharma France Human koagulationsfaktor VIII
English: Octapharma-Ltd Human Coagulation Factor VIII, Human Von Willebrand Factor
Swedish: Octapharma-Ltd Human koagulationsfaktor VIII, human von Willebrandfaktor
English: Octapharma Ab Human Coagulation Factor VIII
Swedish: Octapharma Ab Human koagulationsfaktor VIII
English: Instituto Grifols, S.A. Human Coagulation Factor VIII, Human Von Willebrand Factor
Swedish: Instituto Grifols, S.A. Human koagulationsfaktor VIII, von Willebrand-faktor
English: Intersero Gmbh Human Coagulation Factor VIII
Swedish: Intersero Gmbh Human koagulationsfaktor VIII
English: Human Coagulation Factor VIII 1000 I.E. Human Von Willebrand Factor 2400 I.E.
Swedish: Human koagulationsfaktor VIII 1 000 IE human von Willebrand-faktor 2 400 IE
English: Octapharma Gmbh Human Coagulation Factor VIII
Swedish: Octapharma Gmbh Human koagulationsfaktor VIII
English: Octanate Lv Octapharma Ab Human Coagulation Factor VIII
Swedish: Octanate Lv Octapharma Ab Human koagulationsfaktor VIII
English: Octanate 1000 Octapharma Gmbh Human Coagulation Factor VIII
Swedish: Octanate 1000 Octapharma Gmbh Human koagulationsfaktor VIII
English: Octapharma Ab Human Coagulation Factor VIII, Human Von Willebrand Factor
Swedish: Octapharma Ab Human koagulationsfaktor VIII, human von Willebrandfaktor
English: Octanate 250 Octapharma Gmbh Human Coagulation Factor VIII
Swedish: Octanate 250 Octapharma Gmbh Human koagulationsfaktor VIII
English: Powder And Solvent For Solution For Infusion
Swedish: Pulver och vätska till infusionsvätska, lösning
English: United Kingdom Octanate Lv Octapharma-Ltd Human Coagulation Factor VIII
Swedish: Octanate Lv Octapharma-Ltd Human koagulationsfaktor VIII
English: Human Coagulation Factor VIII 500 I.E., Human Von Willebrand Factor 300 I.E.
Swedish: Human koagulationsfaktor VIII 500 IE, human von Willebrand-faktor 300 IE
English: Human Coagulation Factor VIII 250 I.E., Human Von Willebrand Factor 600 I.E.
Swedish: Human koagulationsfaktor VIII 250 IE, human von Willebrand-faktor 600 IE
English: Wilate 450 Octapharma Gmbh Human Coagulation Factor VIII, Human Von
Swedish: Wilate 450 Octapharma Gmbh Human koagulationsfaktor VIII, human von Willebrandfaktor
English: Octanate 500 Octapharma Gmbh Human Coagulation Factor VIII
Swedish: Octanate 500 Octapharma Gmbh Human koagulationsfaktor VIII
English: Human Coagulation Factor VIII 500 I.E., Human Von Willebrand Factor 1200 I.E.
Swedish: Human koagulationsfaktor VIII 500 IE, human von Willebrand-faktor 1 200 IE
English: Beriate 2000 Csl Behring Gmbh Human Coagulation Factor VIII
Swedish: Beriate 2000 Csl Behring Gmbh Human koagulationsfaktor VIII
English: Octapharma Gmbh Human Coagulation Factor VIII, Human Von Willebrand Factor
Swedish: Octapharma Gmbh Human koagulationsfaktor VIII, human von Willebrandfaktor
English: Human Coagulation Factor VIII 250 I.E. Human Von Willebrand Factor 150 I.E.
Swedish: Human koagulationsfaktor VIII 250 IE, human von Willebrand-faktor 150 IE
English: Beriate 500 Csl Behring Gmbh Human Coagulation Factor VIII
Swedish: Beriate 500 Csl Behring Gmbh Human koagulationsfaktor VIII
English: CSL Behring Gmbh Human Coagulation Factor VIII
Swedish: Csl Behring Gmbh Human koagulationsfaktor VIII
English: Csl Behring Gmbh Human Coagulation Factor VIII
Swedish: CSL Behring Gmbh Human koagulationsfaktor VIII
English: Beriate 250 Csl Behring Gmbh Human Coagulation Factor VIII
Swedish: Beriate 250 Csl Behring Gmbh Human koagulationsfaktor VIII
English: Csl Behring Gmbh Human Coagulation Factor VIII, Human Von Willebrand Factor
Swedish: Csl Behring Gmbh Human koagulationsfaktor VIII (rDNA), human von Willebrand-faktor
English: Aafact
Swedish: Nederländerna Aafact
English: Beriate 1000 Csl Behring Gmbh Human Coagulation Factor VIII
Swedish: Beriate 1000 Csl Behring Gmbh Human koagulationsfaktor VIII
English: Wilate 900 Octapharma Gmbh Human Coagulation Factor VIII, Human Von
Swedish: Wilate 900 Octapharma Gmbh Human koagulationsfaktor VIII, human von Willebrandfaktor
English: Human Coagulation Factor VIII 1000 IU
Swedish: Human koagulationsfaktor VIII 1 000 IE Injektionsflaska
English: Wilate 1000 Octapharma Gmbh Human Coagulation Factor VIII, Human Von
Swedish: Wilate 1000 Octapharma Gmbh Human koagulationsfaktor VIII, human von Willebrandfaktor
English: Human Coagulation Factor VIII 500IU/Vial, Human Von Willebrand Factor 120 I.U.
Swedish: Human koagulationsfaktor VIII 50 IE /ml, von Willebrand-faktor 120 IE /ml
English: Wilate 500 Octapharma Gmbh Human Coagulation Factor VIII, Human Von
Swedish: Wilate 500 Octapharma Gmbh Human koagulationsfaktor VIII, human von Willebrandfaktor
English: Human Coagulation Factor VIII (Rdna) 1000IU/Vial
Swedish: Human koagulationsfaktor VIII (rDNA) 1 000 IE /10 ml
English: Haemate P Csl Behring, S.A Human Coagulation Factor VIII, Von
Swedish: Haemate P Csl Behring, S.A Human koagulationsfaktor VIII, von Willebrand-faktor
English: Haemate P Csl Behring Gmbh Human Coagulation Factor VIII (Rdna),
Swedish: Haemate P Csl Behring Gmbh Human koagulationsfaktor VIII (rDNA), human von
English: Human Coagulation Factor VIII 100 I.U./ml, Human Von Willebrand Factor 100 I.U./ml VIII
Swedish: Human koagulationsfaktor VIII 100 IE /ml, von Willebrand-faktor 25 IE /ml
English: United Kingdom 8y
Swedish: Förenade Kungariket (Storbritannien)
English: Haemate P Csl Behring Mepe Human Coagulation Factor VIII, Human Von
Swedish: Haemate P Csl Behring Mepe Human koagulationsfaktor VIII, human von Willebrandfaktor
English: Human Coagulation Factor VIII (Rdna) 200 I.U.
Swedish: Human koagulationsfaktor VIII (rDNA) 200 IE /ml
English: Human Coagulation Factor VIII 1000 I.E./ Human Von Willebrand Factor 600 I.E.
Swedish: Human koagulationsfaktor VIII 1 000 IE, human von Willebrand-faktor 600 IE
English: / ml, Human Von Willebrand Factor 120 I.U.
Swedish: IE/injektionsflaska, human von Willebrand-faktor 120 IE /ml
English: Human Coagulation Factor VIII (Rdna) 500IU/Vial
Swedish: Human koagulationsfaktor VIII (rDNA) 500 IE /5 ml
English: Human Coagulation Factor VIII 100 IU/ml
Swedish: Human koagulationsfaktor VIII (rDNA) 100 IE /ml
English: Belgium Recombinate Baxalta Innovations Gmbh
Swedish: Nederländerna Recombinate Baxalta Innovations Gmbh
English: Human Coagulation Factor VIII (Rdna) 25 I.U.
Swedish: Human koagulationsfaktor VIII (rDNA) 25 IE /ml
English: Human Coagulation Factor VIII (Rdna) 50 I.U.
Swedish: Human koagulationsfaktor VIII (rDNA) 50 IE /ml
English: Human Coagulation Factor VIII (Rdna) 1000 I.U.
Swedish: Human koagulationsfaktor VIII (rDNA) 1 000
English: Human Coagulation Factor VIII (Rdna) 250IU/Vial
Swedish: Human koagulationsfaktor VIII (rDNA) 250 IE /5 ml
English: Octanate Lv Octapharma Gmbh Human Coagulation Factor VIII
Swedish: Nederländerna Octanate Lv Octapharma Gmbh Human koagulationsfaktor VIII
English: Haemate P Csl Behring Gmbh Human Coagulation Factor VIII, Human Von
Swedish: Haemate P Csl Behring Gmbh Human koagulationsfaktor VIII, human von Willebrandfaktor
English: Human Coagulation Factor VIII (Rdna) 66.6 I.U.
Swedish: Human koagulationsfaktor VIII (rDNA) 66,6 IE /ml, human von Willebrandfaktor 160 IE /ml
English: Cardboard box 1 vial of freezedried antigen and 1 vial of aqueous adjuvant
Swedish: 1 injektionsflaska med frystorkat antigen och 1 injektionsflaska med vattnigt adjuvans
English: Trade name Strength Pharmaceutical Form
Swedish: EU:s aktnummer Fantasinamn Styrka Läkemedelsform Djurslag Administreringssätt
English: Date of first authorisation: 24 June 2016
Swedish: Datum för det första godkännandet: 24 juni 2016
English: HDPE bottles: 3 years Blisters: 5 years
Swedish: HDPE-flaskor: 3 år Blister: 5 år
English: This will help the doctor identify what you have taken.
Swedish: Detta hjälper läkaren att identifiera vad du har tagit.
English: There is no known specific antidote.
Swedish: Det finns ingen känd specifik antidot.
English: The capsules are packaged in bottles or blisters.
Swedish: Kapslarna är förpackade i flaskor eller blister.
English: The magnitude of this effect is not considered to be of clinical relevance.
Swedish: Storleken på den här effekten anses inte ha klinisk relevans.
English: Children and adolescents under the age of 18 years must not take this medicine as it has not been studied in these age groups.
Swedish: Barn och ungdomar under 18 år får inte ta detta läkemedel eftersom det inte har studerats på den här åldersgruppen.
English: There are no or limited amount of data from the use of opicapone in pregnant women.
Swedish: Det finns inga eller begränsad mängd data från användningen av opikapon i gravida kvinnor.
English: Follow the instructions that your doctor has given you.
Swedish: Följ anvisningarna du har fått av läkaren.
English: At screening, the mean age was similar in all treatment groups in both studies, ranging between 61.5 and 65.3 years.
Swedish: Vid screening var medelåldern lika i alla behandlingsgrupperna i båda studierna, mellan 61,5 och 65,3 år.
English: Caution must be exercised in patients ≥ 85 years of age as there is limited experience in this age group.
Swedish: Försiktighet måste iakttas hos patienter ≥ 85 år eftersom erfarenheten är begränsad hos denna åldersgrupp.
English: Your doctor may need to reconsider your treatment.
Swedish: Läkaren kan behöva ompröva din behandling.
English: Very common: may affect more than 1 in 10 people - involuntary and uncontrollable, or difficult or painful body movements
Swedish: Mycket vanliga: kan förekomma hos fler än 1 av 10 användare - ofrivilliga och okontrollerbara, eller svåra och smärtsamma kroppsrörelser
English: Other medicines and Ongentys
Swedish: Andra läkemedel och Ongentys
English: Symptomatic and supportive treatment should be administered as appropriate.
Swedish: Lämplig symtomatisk och stödjande behandling ska administreras.
English: Dyskinesia was the most frequently reported treatment-emergent adverse reaction (17.7%).
Swedish: Dyskinesi var den vanligaste rapporterade behandlingsrelaterade biverkningen (17,7 %).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Swedish: Du kan också rapportera biverkningar direkt via det nationella rapporteringssystemet listat bilaga V. Genom att rapportera biverkningar kan du bidra till att öka informationen om läkemedels säkerhet.
English: Although embryo-foetal development was not negatively influenced in rabbits, the study is not considered predictive for human risk assessment.
Swedish: Även om embryofetal utveckling hos kaniner inte påverkades negativt ansågs studien inte vara prediktiv för riskbedömning hos människa.
English: Patients should be monitored regularly for the development of impulse control disorders and review of treatment is recommended if such symptoms develop.
Swedish: Patienterna ska kontrolleras regelbundet för utvecklande av impulskontrollstörningar och en översyn av behandlingen rekommenderas om sådana symtom uppstår.
English: Do not stop taking Ongentys unless your doctor tells you to as your symptoms may get worse.
Swedish: Sluta inte ta Ongentys om inte läkaren talar om att du ska göra det eftersom symtomen kan förvärras.
English: Contact your doctor straight away if you experience any side effects at the start of treatment.
Swedish: Kontakta omedelbart läkaren om du upplever biverkningar i början av behandlingen.
English: 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).
Swedish: Frekvenskategorierna definieras enligt följande: mycket vanliga (≥ 1/10), vanliga (> 1/100, < 1/10), mindre vanliga (> 1/1 000, < 1/100), sällsynta (> 1/10 000, < 1/1 000) och ingen känd frekvens (kan inte beräknas från tillgängliga data).
English: These behaviours are called ‘impulse control disorders' and can include: addictive gambling, an abnormally high sex drive or an increased preoccupation with sexual thoughts or feelings.
Swedish: Dessa beteenden kallas 'impulskontrollstörningar, 'och kan omfatta: spelmissbruk, en ovanligt kraftig sexlust eller ett ökat intresse för sexuella tankar eller känslor.
English: Overall, it can be concluded that the kidney is not the primary route of excretion.
Swedish: Slutsatsen blir därför att njurarna inte är den primära utsöndringsvägen.
English: Therefore, caution should be exercised when driving or using machines.
Swedish: Försiktighet ska därför iakttas vid framförande av fordon eller användning av maskiner.
English: For patients who experience progressive anorexia, asthenia and weight decrease within a relatively short period of time, a general medical evaluation including liver function should be considered.
Swedish: Hos patienter som upplever progressiv anorexi, asteni och viktminskning under en relativt kort tidsperiod bör en medicinsk bedömning inklusive leverfunktion övervägas.
English: Note: A responder was a patient who had a reduction of at least 1 hour in absolute OFF-time (OFF-time responder)
Swedish: Amn: En responder var en patient som hade en minskning på minst 1 timme av absolut OFF-tid (OFF-tidresponder)
English: What Ongentys is and what it is used for
Swedish: Vad Ongentys är och vad det används för
English: Taking Ongentys and quinidine together, i.e. at the same time, may decrease the effect of Ongentys.
Swedish: Intag av Ongentys och kinidin tillsammans, dvs. vid samma tidpunkt, kan minska effekten av Ongentys.
English: 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).
Swedish: Det är således ofta nödvändigt att justera levodopadosen inom de första dagarna till veckorna efter att behandling med opikapon har påbörjats (se avsnitt 4.4).
English: Medicinal products metabolised by COMT
Swedish: Läkemedel som metaboliseras av COMT
English: All reductions in activity essentially occurred at the highest concentration of opicapone (10 mcg/mL).
Swedish: Alla minskningar av aktivitet inträffade i huvudsak vid den högsta koncentrationen av opikapon (10 µg/ml).
English: Some side effects may be caused by the increased effects of using Ongentys together with levodopa.
Swedish: Vissa biverkningar kan orsakas av den ökade effekten av användning av Ongentys tillsammans med levodopa.
English: Table 1 - Frequency of adverse reactions (MedDRA) in placebo-controlled Phase 3 studies System Organ Class
Swedish: Tabell 1 - Frekvens av biverkningar (MedDRA) i placebo-kontrollerade fas 3-studier Organsystem