natgillin/translations-raw huggingface dataset:
Olanzapine Teva 7.5 mg film-coated tablets EU/1/07/427/008 - 28 tablets, per box EU/1/07/427/077 - 28 x 1 tablets, per box EU/1/07/427/009 - 30 tablets, per box EU/1/07/427/078 - 30 x 1 tablets, per box EU/1/07/427/040 - 35 tablets, per box EU/1/07/427/079 - 35 x 1 tablets, per box EU/1/07/427/010 - 56 tablets, per box EU/1/07/427/080 - 56 x 1 tablets, per box EU/1/07/427/068 - 60 tablets, per box EU/1/07/427/050 - 70 tablets, per box EU/1/07/427/081 - 70 x 1 tablets, per box EU/1/07/427/060 - 98 tablets, per box EU/1/07/427/082 - 98 x 1 tablets, per box 
Olanzapine Teva 7,5 mg comprimate filmate EU/1/07/427/008 - 28 comprimate, pe cutie EU/1/07/427/077 - 28 x 1 comprimate, pe cutie EU/1/07/427/009 - 30 comprimate, pe cutie EU/1/07/427/078 - 30 x 1 comprimate, pe cutie EU/1/07/427/040 - 35 comprimate, pe cutie EU/1/07/427/079 - 35 x 1 comprimate, pe cutie EU/1/07/427/010 - 56 comprimate, pe cutie EU/1/07/427/080 - 56 x 1 comprimate, pe cutie EU/1/07/427/068 - 60 comprimate, pe cutie EU/1/07/427/050 - 70 comprimate, pe cutie EU/1/07/427/081 - 70 x 1 comprimate, pe cutie EU/1/07/427/060 - 98 comprimate, pe cutie EU/1/07/427/082 - 98 x 1 comprimate, pe cutie
Olanzapine Teva 15 mg orodispersible tablets EU/1/07/427/031 - 28 tablets, per box 
Olanzapine Teva 15 mg comprimate orodispersabile EU/1/07/427/031 - 28 comprimate, pe cutie
OPA-Al-PVC/Al blisters in cartons of 28, 30, 35, 56, 70 or 98 orodispersible tablets per carton. 
Blistere OPA-Al-PVC/Al, în cutii conținând 28, 30, 35, 56, 70 sau 98 comprimate orodispersabile.
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 
28 comprimate filmate 28 x 1 comprimate filmate 30 comprimate filmate 30 x 1 comprimate filmate 35 comprimate filmate 35 x 1 comprimate filmate 50 comprimate filmate 50 x 1 comprimate filmate 56 comprimate filmate 56 x 1 comprimate filmate 70 comprimate filmate 70 x 1 comprimate filmate 98 comprimate filmate 98 x 1 comprimate filmate
EU/1/07/427/029 - 50 tablets, per box 
EU/1/07/427/029 - 50 comprimate, pe cutie
Olanzapine Teva 10 mg orodispersible tablet is a yellow, round, biconvex tablet, with 10 mm of diameter. 
Comprimatul orodispersabil de Olanzapine Teva 10 mg este rotund, biconvex, de culoare galbenă, cu diametrul de 10 mm.
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 
28 comprimate filmate 28 x 1 comprimate filmate 30 comprimate filmate 30 x 1 comprimate filmate 35 comprimate filmate 35 x 1 comprimate filmate 56 comprimate filmate 56 x 1 comprimate filmate 60 comprimate filmate 70 comprimate filmate 70 x 1 comprimate filmate 98 comprimate filmate 98 x 1 comprimate filmate
28 film-coated tablets 30 film-coated tablets 35 film-coated tablets 50 film-coated tablets 56 film-coated tablets 70 film-coated tablets 98 film-coated tablets 
28 comprimate filmate 30 comprimate filmate 35 comprimate filmate 50 comprimate filmate 56 comprimate filmate 70 comprimate filmate 98 comprimate filmate
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. 
Comprimatul filmat de Olanzapine Teva 5 mg este rotund, biconvex, de culoare albă, gravat cu „OL 5” pe una dintre fețe și simplu pe cealaltă față.
Pregnancy and breast-feeding 
• Boală de ficat sau rinichi
(≥ 1.016 mmol/l-<1.467 mmol/l) to high (≥1.467 mmol/l). 
14 Observată pentru valori inițiale normale în condiții de repaus alimentar (<1,016 mmol/l) care au atins valori crescute (≥1,467 mmol/l) și modificările valorilor inițiale ale trigliceridelor de la valori limită (≥1,016 mmol/l-<1,467 mmol/l) în condiții de repaus alimentar la valori crescute (≥1,467 mmol/l).
Olanzapine Teva 2.5 mg film-coated tablets are available in cartons of 28, 30, 35, 56, 70 or 98 filmcoated tablets. 
Comprimatele filmate de Olanzapine Teva 2,5 mg sunt disponibile în cutii care conțin 28, 30, 35, 56, 70 sau 98 comprimate filmate.
Olanzapine Teva 15 mg film-coated tablet is a light blue, biconvex, oval film-coated tablet, debossed ”OL 15” on one side and plain on the other. 
Comprimatul filmat de Olanzapine Teva 15 mg este oval, biconvex, de culoare albastru deschis, gravat cu „OL 15” pe una dintre fețe și simplu pe cealaltă față.
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. 
La pacienții care au răspuns inițial la olanzapină, tratamentul de întreținere cu olanzapină este eficace în menținerea ameliorării clinice.
EU/1/07/427/052 - 70 tablets, per box EU/1/07/427/062 - 98 tablets, per box 
EU/1/07/427/003 - 56 comprimate, pe cutie EU/1/07/427/048 - 70 comprimate, pe cutie EU/1/07/427/058 - 98 comprimate, pe cutie
Anticholinergic activity 
Incontinență urinară
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. 
Olanzapine Teva 15 mg comprimate orodispersabile Blistere OPA-Al-PVC/Al, în cutii conținând 28, 30, 35, 50, 56, 70 sau 98 comprimate orodispersabile.
Changes in total fasting cholesterol levels from borderline at baseline 
15 Modificări ale valorilor colesterolului total, normale inițial în condiții de repaus alimentar
EU/1/07/427/028 - 30 tablets, per box 
EU/1/07/427/028 - 30 comprimate, pe cutie
EU/1/07/427/036 - 30 tablets, per box 
EU/1/07/427/036 - 30 comprimate, pe cutie
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. 
Comprimatele filmate de Olanzapine Teva 5 mg sunt disponibile în cutii care conțin 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 sau 98 x 1 comprimate filmate.
Olanzapine Teva 20 mg film-coated tablets are available in cartons of 28, 30, 35, 56, 70 or 98 filmcoated tablets. 
Comprimatele filmate de Olanzapine Teva 20 mg sunt disponibile în cutii care conțin 28, 30, 35, 56, 70 sau 98 comprimate filmate.
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. 
Comprimatele filmate de Olanzapine Teva 7,5 mg sunt disponibile în cutii care conțin 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 sau 98 x 1 comprimate filmate.
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. 
Comprimatele filmate de Olanzapine Teva 10 mg sunt disponibile în cutii care conțin 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 sau 98 x 1 comprimate filmate.
EU/1/07/427/032 - 30 tablets, per box 
EU/1/07/427/032 - 30 comprimate, pe cutie
Olanzapine Teva with alcohol 
Olanzapine Teva
EU/1/07/427/025 - 50 tablets, per box 
EU/1/07/427/025 - 50 comprimate, pe cutie
During treatment with olanzapine in combination with lithium or divalproex, an increase of ≥7% from baseline body weight occurred in 17.4% of patients during acute treatment (up to 6 weeks). 
În timpul tratamentului cu olanzapină în asociere cu litiu sau divalproex, în faza tratamentului acut (până la 6 săptămâni) la
EU/1/07/427/056 - 70 tablets, per box 
EU/1/07/427/056 - 70 comprimate, pe cutie
EU/1/07/427/030 - 56 tablets, per box 
EU/1/07/427/030 - 56 comprimate, pe cutie
EU/1/07/427/046 - 35 tablets, per box 
EU/1/07/427/046 - 35 comprimate, pe cutie
EU/1/07/427/026 - 56 tablets, per box 
EU/1/07/427/026 - 56 comprimate, pe cutie
EU/1/07/427/065 - 98 tablets, per box 
EU/1/07/427/065 - 98 comprimate, pe cutie
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. 
Blistere OPA-Al-PVC/Al, în cutii conținând 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 sau 98 x 1 comprimate filmate.
EU/1/07/427/037 - 56 tablets, per box 
EU/1/07/427/037 - 56 comprimate, pe cutie
EU/1/07/427/033 - 50 tablets, per box 
EU/1/07/427/033 - 50 comprimate, pe cutie
4 Observed for fasting normal levels at baseline (<5.56 mmol/l) which increased to high (≥7 mmol/l). 
<5,56 mmol/l) care au atins valori crescute ( ≥7 mmol/l).
EU/1/07/427/024 - 30 tablets, per box 
EU/1/07/427/024 - 30 comprimate, pe cutie
EU/1/07/427/066 - 98 tablets, per box 
EU/1/07/427/066 - 98 comprimate, pe cutie
EU/1/07/427/055 - 70 tablets, per box 
EU/1/07/427/055 - 70 comprimate, pe cutie
Mannitol 
Artralgie
EU/1/07/427/034 - 56 tablets, per box 
EU/1/07/427/034 - 56 comprimate, pe cutie
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. 
Blistere OPA-Al-PVC/Al, în cutii conținând 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 sau 98 x 1 comprimate filmate.
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. 
Blistere OPA-Al-PVC/Al, în cutii conținând 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 sau 98 x 1 comprimate filmate.
Olanzapine Teva 7.5 mg film-coated tablets Each film-coated tablet contains 7.5 mg olanzapine. 
Fiecare comprimat filmat conține olanzapină 7,5 mg.
EU/1/07/427/054 - 70 tablets, per box 
EU/1/07/427/054 - 70 comprimate, pe cutie
EU/1/07/427/057 - 70 tablets, per box 
EU/1/07/427/057 - 70 comprimate, pe cutie
(≥5.17 mmol/l) were observed commonly. 
(<4,39 mmol/l) și care au atins valori crescute (≥5,17 mmol/l) s-au observat frecvent.
Tell your doctor immediately if you have: - unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue; - blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people) especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. 
persoane) în special la nivelul picioarelor (simptomele includ umflare, durere și roșeața picioarelor), care pot să migreze de-a lungul vaselor până în plămâni și pot provoca durere în piept și dificultăți de respirație.Dacă observați oricare dintre aceste simptome cereți imediat ajutor medical
Management 
PIAȚĂ
Development or exacerbation of 
Sarcina și alăptarea
EU/1/07/427/064 - 98 tablets, per box 
EU/1/07/427/064 - 98 comprimate, pe cutie
Other medicines and Olanzapine Teva 
Conținutul ambalajului și alte informații Ce conține Olanzapine Teva
EU/1/07/427/067 - 98 tablets, per box 
EU/1/07/427/067 - 98 comprimate, pe cutie
EU/1/07/427/044 - 35 tablets, per box 
EU/1/07/427/044 - 35 comprimate, pe cutie
EU/1/07/427/045 - 35 tablets, per box 
EU/1/07/427/045 - 35 comprimate, pe cutie
INFORMATION IN BRAILLE Olanzapine Teva 2.5 mg film-coated tablets 
Olanzapine Teva 2,5 mg comprimate filmate
EU/1/07/427/047 - 35 tablets, per box 
EU/1/07/427/047 - 35 comprimate, pe cutie
Olanzapine Teva 15 mg film-coated tablets EU/1/07/427/016 - 28 tablets, per box 
Olanzapine Teva 15 mg comprimate filmate EU/1/07/427/016 - 28 comprimate, pe cutie EU/1/07/427/017 - 30 comprimate, pe cutie
Changes in fasting triglycerides from borderline at baseline 
Amenoree Mărirea în volum a sânilor
Olanzapine Teva 20 mg film-coated tablets Each film-coated tablet contains 20 mg olanzapine. 
Fiecare comprimat filmat conține olanzapină 20 mg.
Olanzapine Teva 7.5 mg film-coated tablets White, biconvex, round film-coated tablets, debossed ”OL 7.5” on one side and plain on the other. 
Comprimate filmate rotunde, biconvexe, de culoare albă, gravate cu „OL 7.5” pe una dintre fețe și simple pe cealaltă față.
Annex I List of medicinal products and presentations 
Lista medicamentelor și prezentări
Czech Republic Immunate Stim Plus 
Republica Cehă Immunate Stim Plus
United Kingdom 8y 
Marea Britanie 8y
Germany Faktor VIII Sdh Intersero 
Germania Faktor VIII Sdh Intersero
Czech Republic Optivate 
Republica Cehă Optivate
United Kingdom Optivate 
Marea Britanie Optivate
Recombinant coagulation factor VIII (octocog alfa) 
Factor VIII de coagulare recombinant (octocog alfa)
Belgium Factane 1000 IU/10 ml 
Factane 1000 UI/10 ml
Belgium Factane 500 IU - 5 ml 
Factane 500 UI - 5 ml
Czech Republic Beriate 
Republica Cehă Beriate
United Kingdom Alphanate 
Marea Britanie Alphanate
Czech Republic Fanhdi 
Republica Cehă Fanhdi
Czech Republic Wilate 
Republica Cehă Wilate
Powder For Injection Intravenous Use 
Pulbere pentru injecție Administrare intravenoasă
Recombinate Baxalta Poland Sp. z o.o. 
Recombinate Baxalta Poland Sp.
United Kingdom Fanhdi 
Marea Britanie Fanhdi
Powder And Solvent For Solution For Infusion 
Pulbere și solvent pentru soluție perfuzabilă
United Kingdom Wilate 
Marea Britanie Wilate
Czech Republic Octanate 
Republica Cehă Octanate
Haemoctin Biotest Hungaria Kft. Human Coagulation Factor VIII 
Haemoctin Biotest Hungaria Kft. Factor VIII de coagulare uman
United Kingdom Octanate 
Marea Britanie Octanate
Baxalta Poland Sp. z o.o. 
Baxalta Poland Sp.
Czech Republic Haemoctin Sdh 
Republica Cehă Haemoctin Sdh
Grifols Italia S.P.A Human Coagulation Factor VIII, Human Von Willebrand Factor 
Grifols Italia S.P.A Factor VIII de coagulare uman, Factor uman Von Willebrand
Lfb Biomedicaments Human Coagulation Factor VIII 
LFB Biomedicaments Factor VIII de coagulare uman
LFB Biomedicaments Human Coagulation Factor VIII 
Lfb Biomedicaments Factor VIII de coagulare uman
Human Coagulation Factor VIII 200 IU/ml 
Factor VIII de coagulare uman 200 UI/ml
Instituto Grifols, S.A. Human Coagulation Factor VIII 
Instituto Grifols, S.A. Factor VIII de coagulare uman
Human Coagulation Factor VIII 250 I.E. 
Factor VIII de coagulare uman 250 I.E.
Instituto Grifols, S.A. Human Coagulation Factor VIII, Von 
Instituto Grifols, S.A. Factor VIII de coagulare uman, Factor Von
Human Coagulation Factor VIII 1000 I.E. 
Factor VIII de coagulare uman 1000 I.E.
Czech Republic Recombinate Baxalta Innovations GmbH 
Republica Cehă Recombinate Baxalta Innovations GmbH
Instituto Grifols, S.A. Human Coagulation Factor VIII, Human Von Willebrand Factor 
Instituto Grifols, S.A. Factor VIII de coagulare uman, Factor uman Von Willebrand
Octapharma-Ltd Human Coagulation Factor VIII 
Octapharma-Ltd Factor VIII de coagulare uman
Human Coagulation Factor VIII 100 IU/ml 
Factor VIII de coagulare uman 100 UI/ml
Octapharma France Human Coagulation Factor VIII 
Octapharma France Factor VIII de coagulare uman
Octanate LV Octapharma France Human Coagulation Factor VIII 
Octanate LV Octapharma France Factor VIII de coagulare uman
Human Coagulation Factor VIII 1500 I.E. 
Factor VIII de coagulare uman 1500 I.E.
Human Von Willebrand 
Willebrand
Intersero Gmbh Human Coagulation Factor VIII 
Intersero Gmbh Factor VIII de coagulare uman
Human Coagulation Factor VIII 1000 I.E. Human Von Willebrand Factor 2400 I.E. 
Factor VIII de coagulare uman 1000 I.E. Factor uman Von Willebrand 2400 I.E.
Human Coagulation Factor VIII 2000 IU 
Factor VIII de coagulare uman 2000 UI
Octapharma Ab Human Coagulation Factor VIII 
Octapharma Ab Factor VIII de coagulare uman
Octanate Lv Octapharma Ab Human Coagulation Factor VIII 
Octanate Lv Octapharma Ab Factor VIII de coagulare uman
Human Coagulation Factor VIII 500 I.E. 
Factor VIII de coagulare uman 500 I.E.
Human Coagulation Factor VIII 1000 IU 
Factor VIII de coagulare uman 1000 UI
United Kingdom Octanate Lv Octapharma-Ltd Human Coagulation Factor VIII 
Marea Britanie Octanate Lv Octapharma-Ltd Factor VIII de coagulare uman
Octanate 250 Octapharma Gmbh Human Coagulation Factor VIII 
Octanate 250 Octapharma Gmbh Factor VIII de coagulare uman
Csl Behring Gmbh Human Coagulation Factor VIII, Human Von Willebrand Factor 
Csl Behring Gmbh Factor VIII de coagulare uman, Factor uman Von Willebrand
Human Coagulation Factor VIII (Rdna) 250IU/Vial 
Factor VIII de coagulare uman (rDNA) 250UI/flacon
United Kingdom Haemoctin Biotest Pharma Gmbh 
Marea Britanie Haemoctin Biotest Pharma Gmbh
Octanate 1000 Octapharma Gmbh Human Coagulation Factor VIII 
Octanate 1000 Octapharma Gmbh Factor VIII de coagulare uman
Octapharma Ab Human Coagulation Factor VIII, Human Von Willebrand Factor 
Octapharma Ab Factor VIII de coagulare uman, Factor uman Von Willebrand
Octapharma Gmbh Human Coagulation Factor VIII, Human Von Willebrand Factor 
Octapharma Gmbh Factor VIII de coagulare uman, Factor uman Von Willebrand
Human Coagulation Factor VIII (Rdna) 1000IU/Vial 
Factor VIII de coagulare uman (rDNA) 1000UI/flacon
Human Coagulation Factor VIII 250 IUVIII 
Factor VIII de coagulare uman 250 UI
Octapharma Gmbh Human Coagulation Factor VIII 
Octapharma Gmbh Factor VIII de coagulare uman
Human Coagulation Factor VIII 500 IU 
Factor VIII de coagulare uman 500 UI
Human Coagulation Factor VIII 250 I.E. Human Von Willebrand Factor 150 I.E. 
Factor VIII de coagulare uman 250 I.E., Factor uman Von Willebrand 150 I.E.
Human Coagulation Factor VIII 500 I.E., Human Von Willebrand Factor 1200 I.E. 
Factor VIII de coagulare uman 500 I.E., Factor uman Von Willebrand 1200 I.E.
Haemate P Csl Behring, S.A Human Coagulation Factor VIII, Von 
Haemate P Csl Behring, S.A Factor VIII de coagulare uman, Factor Von
Wilate 450 Octapharma Gmbh Human Coagulation Factor VIII, Human Von 
Wilate 450 Octapharma Gmbh Factor VIII de coagulare uman, Factor uman Von
Human Coagulation Factor VIII 100 I.U./ml, Human Von Willebrand Factor 100 I.U./ml VIII 
Factor VIII de coagulare uman 100 U.I/ml, Factor uman Von Willebrand 100 U.I/ml VIII
Human Coagulation Factor VIII 500 I.E., Human Von Willebrand Factor 300 I.E. 
Factor VIII de coagulare uman 500 I.E., Factor uman Von Willebrand 300 I.E.
Human Coagulation Factor VIII 250 I.E., Human Von Willebrand Factor 600 I.E. 
Factor VIII de coagulare uman 250 I.E., Factor uman Von Willebrand 600 I.E.
Human Coagulation Factor VIII 500IU/Vial 
Factor VIII de coagulare uman 500UI/flacon
Octapharma-Ltd Human Coagulation Factor VIII, Human Von Willebrand Factor 
Octapharma-Ltd Factor VIII de coagulare uman, Factor uman Von Willebrand
Beriate 250 Csl Behring Gmbh Human Coagulation Factor VIII 
Beriate 250 Csl Behring Gmbh Factor VIII de coagulare uman
Octanate Lv Octapharma Gmbh Human Coagulation Factor VIII 
Octanate Lv Octapharma Gmbh Factor VIII de coagulare uman
Human Coagulation Factor VIII 1000IU/Vial 
Factor VIII de coagulare uman 1000UI/flacon
Beriate 2000 Csl Behring Gmbh Human Coagulation Factor VIII 
Beriate 2000 Csl Behring Gmbh Factor VIII de coagulare uman
Octanate 500 Octapharma Gmbh Human Coagulation Factor VIII 
Octanate 500 Octapharma Gmbh Factor VIII de coagulare uman
Human Coagulation Factor VIII, Human Von Willebrand FactorVIII 
Factor VIII de coagulare uman, Factor uman Von Willebrand Factor
Beriate 1000 Csl Behring Gmbh Human Coagulation Factor VIII 
Beriate 1000 Csl Behring Gmbh Factor VIII de coagulare uman
Wilate 1000 Octapharma Gmbh Human Coagulation Factor VIII, Human Von 
Wilate 1000 Octapharma Gmbh Factor VIII de coagulare uman, Factor uman Von
Beriate 500 Csl Behring Gmbh Human Coagulation Factor VIII 
Beriate 500 Csl Behring Gmbh Factor VIII de coagulare uman
Wilate 900 Octapharma Gmbh Human Coagulation Factor VIII, Human Von 
Wilate 900 Octapharma Gmbh Factor VIII de coagulare uman, Factor uman Von
Human Coagulation Factor VIII 1000IU/Vial, Human Von Willebrand Factor 75 I.U. 
Factor VIII de coagulare uman 1000UI/flacon, Factor uman Von Willebrand 75 U.I. /ml
Wilate 500 Octapharma Gmbh Human Coagulation Factor VIII, Human Von 
Wilate 500 Octapharma Gmbh Factor VIII de coagulare uman, Factor uman Von
Human Coagulation Factor VIII 1000 I.E./ Human Von Willebrand Factor 600 I.E. 
Factor VIII de coagulare uman 1000 I.E., Factor uman Von Willebrand 600 I.E.
Human Coagulation Factor VIII 250IU/Vial 
Factor VIII de coagulare uman 250UI/flacon
Human Coagulation Factor VIII (Rdna) 500IU/Vial 
Factor VIII de coagulare uman (rDNA) 500UI/flacon
Human Coagulation Factor VIII (Rdna) 100 I.U. 
Factor VIII de coagulare uman (rDNA) 100 U.I. /ml
Csl Behring Gmbh Human Coagulation Factor VIII 
CSL Behring Gmbh Factor VIII de coagulare uman
CSL Behring Gmbh Human Coagulation Factor VIII 
Csl Behring Gmbh Factor VIII de coagulare uman
Czech Republic Haemate P Csl Behring Gmbh Human Coagulation Factor VIII (Rdna), 
Republica Cehă Haemate P Csl Behring Gmbh Factor VIII de coagulare uman (rDNA), Factor uman Von Willebrand
Human Coagulation Factor VIII (Rdna) 200 I.U. 
Factor VIII de coagulare uman (rDNA) 200 U.I. /ml
Haemate P Csl Behring Mepe Human Coagulation Factor VIII, Human Von 
Haemate P Csl Behring Mepe Factor VIII de coagulare uman, Factor uman Von
United Kingdom Haemate P Csl Behring Gmbh Human Coagulation Factor VIII, Human Von 
Marea Britanie Haemate P Csl Behring Gmbh Factor VIII de coagulare uman, Factor uman Von
Human Coagulation Factor VIII (Rdna) 1000 I.U. 
Factor VIII de coagulare uman (rDNA) 1000 U.I. Flacon
Human Coagulation Factor VIII 500IU/Vial, Human Von Willebrand Factor 38 I.U. 
Factor VIII de coagulare uman 500UI/flacon, Factor uman Von Willebrand 38 U.I. /ml
Human Coagulation Factor VIII (Rdna) 25 I.U. 
Factor VIII de coagulare uman (rDNA) 25 U.I. /ml
Human Coagulation Factor VIII (Rdna) 250 I.U. 
Factor VIII de coagulare uman (rDNA) 250 U.I. Flacon
Human Coagulation Factor VIII (Rdna) 500 I.U. 
Factor VIII de coagulare uman (rDNA) 500 U.I. Flacon
Human Coagulation Factor VIII 100 I.U./ml, Human Von Willebrand Factor 100 I.U./mlVIII 
Factor VIII de coagulare uman 100 U.I. /ml, Factor Von Willebrand 25 U.I. /ml
Human Coagulation Factor VIII (Rdna) 50 I.U. 
Factor VIII de coagulare uman (rDNA) 50 U.I. /ml
Human Coagulation Factor VIII 500IU/Vial, Human Von Willebrand Factor 120 I.U. 
Factor VIII de coagulare uman 500UI/flacon, Factor uman Von Willebrand 120 U.I. /ml
Haemate P Csl Behring Gmbh Human Coagulation Factor VIII, Human Von 
Haemate P CSL Behring Gmbh Factor VIII de coagulare uman, Factor uman Von
Haemate P CSL Behring Gmbh Human Coagulation Factor VIII, Human Von 
Haemate P Csl Behring Gmbh Factor VIII de coagulare uman, Factor uman Von
Cardboard box 1 vial of freezedried antigen and 1 vial of aqueous adjuvant 
1 flacon cu antigen liofilizat şi un flacon cu solvent apos
Date of first authorisation: 24 June 2016 
Data primei autorizări: 24 iunie 2016
There is no known specific antidote. 
Nu se cunoaşte un antidot specific.
Children and adolescents under the age of 18 years must not take this medicine as it has not been studied in these age groups. 
Copiii şi adolescenţii cu vârsta sub 18 ani nu trebuie să ia acest medicament deoarece nu a fost studiat la aceste grupe de vârstă.
Overall, it can be concluded that the kidney is not the primary route of excretion. 
În general, se poate deduce că rinichiul nu este principala cale de excreţie.
Ask your pharmacist how to throw away medicines you no longer use. 
Întrebaţi farmacistul cum să eliminaţi medicamentele pe care nu le mai folosiți.
Opicapone presents a low absorption (~20%). 
Opicapona prezintă o absorbţie scăzută (~20%).
At screening, the mean age was similar in all treatment groups in both studies, ranging between 61.5 and 65.3 years. 
La selecţie, vârsta medie a fost aceeași în toate grupurile de tratament în ambele studii, variind între 61,5 și 65,3 ani.
The most common adverse reactions reported were nervous system disorders. 
Cele mai frecvente reacţii adverse raportate au fost tulburările sistemului nervos central.
Swallow the capsule whole with a glass of water. 
Înghiţiţi capsula întreagă cu un pahar cu apă.
A risk to the newborns/infants cannot be excluded. 
Nu se poate exclude un risc pentru nou născuți/sugari.