natgillin/translations-raw huggingface dataset:
Zalasta 2,5 mg tabletter Zalasta 5 mg tabletter Zalasta 7,5 mg tabletter Zalasta 10 mg tabletter Zalasta 15 mg tabletter Zalasta 20 mg tabletter olanzapin 
Zalasta 2.5 mg tablets Zalasta 5 mg tablets Zalasta 7.5 mg tablets Zalasta 10 mg tablets Zalasta 15 mg tablets Zalasta 20 mg tablets Olanzapine
1 tablet indeholder 7,5 mg olanzapin. 
Each tablet contains 7.5 mg olanzapine.
1 tablet indeholder 20 mg olanzapin. 
Each tablet contains 20 mg olanzapine.
Zalasta 15 mg tabletter olanzapin 
Zalasta 15 mg tablets Olanzapine
Zalasta 5 mg tabletter olanzapin 
Zalasta 5 mg tablets Olanzapine
Zalasta 15 mg smeltetablet EU/1/07/415/047-051 
Zalasta 15 mg orodispersible tablets EU/1/07/415/047-051
Malignt neuroleptikasyndrom (se pkt. 
Neuroleptic malignant syndrome (see section 4.4) Discontinuation symptoms
Zalasta 10 mg tabletter olanzapin 
Zalasta 10 mg tablets Olanzapine
Slug tabletterne med eller uden vand Du kan også lægge tabletten i et glas vand og drikke det med det samme. 
Swallow the tablet with or without water.
Zalasta 20 mg tabletter Hver tablet indeholder 323,5 mg lactose. 
Each tablet contains 323.5 mg lactose.
Zalasta 7,5 mg smeltetablet EU/1/07/415/037-041 
Zalasta 7.5 mg orodispersible tablets EU/1/07/415/037-041
Passende klinisk monitorering tilrådes i overensstemmelse med anvendte antipsykotiske vejledninger, som f.eks. måling af blodsukker ved baseline, 12 uger efter start på olanzapinbehandling og derefter årligt.Patienter i behandling med antipsykotika herunder Zalasta bør observeres for tegn og symptomer på hyperglykæmi (som polydipsi, polyuri, polyfagi og svaghed). 
Patients treated with any antipsychotic medicines, including Zalasta, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Zalasta 7,5 mg smeltetablet Tabletterne er gule, runde, let bikonvekse, marmorerede tabletter med mulige, individuelle pletter. 
Zalasta 7.5 mg orodispersible tablets Tablets are round, slightly biconvex, yellow marbled tablets with possible individual spots.
1 tablet indeholder 5 mg olanzapin. 
Each tablet contains 5 mg olanzapine.
1 tablet indeholder 15 mg olanzapin. 
Each tablet contains 15 mg olanzapine.
Zalasta 20 mg smeltetablet EU/1/07/415/052-056 
Zalasta 20 mg orodispersible tablets EU/1/07/415/052-056
Fremstiller KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenien 
Manufacturer KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
1 tablet indeholder 10 mg olanzapin. 
Each tablet contains 10 mg olanzapine.
Zalasta 20 mg smeltetablet Tabletterne er gule, runde, let bikonvekse, marmorerede tabletter med mulige, individuelle pletter. 
Zalasta 20 mg orodispersible tablets Tablets are round, slightly biconvex, yellow marbled tablets with possible individual spots.
Zalasta 10 mg smeltetablet EU/1/07/415/042-046 
Zalasta 10 mg orodispersible tablets EU/1/07/415/042-046
Zalasta 5 mg smeltetablet EU/1/07/415/032-036 
Zalasta 5 mg orodispersible tablets EU/1/07/415/032-036
EU/1/07/415/006 (14 tabletter) EU/1/07/415/007 (28 tabletter) EU/1/07/415/008 (35 tabletter) EU/1/07/415/009 (56 tabletter) EU/1/07/415/010 (70 tabletter) 
EU/1/07/415/006 (14 tablets) EU/1/07/415/007 (28 tablets) EU/1/07/415/008 (35 tablets) EU/1/07/415/009 (56 tablets) EU/1/07/415/010 (70 tablets)
EU/1/07/415/016 (7 tabletter) EU/1/07/415/017 (14 tabletter) EU/1/07/415/018 (28 tabletter) EU/1/07/415/019 (35 tabletter) EU/1/07/415/020 (56 tabletter) EU/1/07/415/021 (70 tabletter) 
EU/1/07/415/016 (7 tablets) EU/1/07/415/017 (14 tablets) EU/1/07/415/018 (28 tablets) EU/1/07/415/019 (35 tablets) EU/1/07/415/020 (56 tablets) EU/1/07/415/021 (70 tablets)
EU/1/07/415/001 (14 tabletter) EU/1/07/415/002 (28 tabletter) EU/1/07/415/003 (35 tabletter) EU/1/07/415/004 (56 tabletter) EU/1/07/415/005 (70 tabletter) 
EU/1/07/415/001 (14 tablets) EU/1/07/415/002 (28 tablets) EU/1/07/415/003 (35 tablets) EU/1/07/415/004 (56 tablets) EU/1/07/415/005 (70 tablets)
Abstinenssymptomer 
Hepatobiliary disorders
Hæmatologisk toksicitet 
Haematologic toxicity:
EU/1/07/415/022 (14 tabletter) EU/1/07/415/023 (28 tabletter) EU/1/07/415/024 (35 tabletter) EU/1/07/415/025 (56 tabletter) EU/1/07/415/026 (70 tabletter) 
EU/1/07/415/022 (14 tablets) EU/1/07/415/023 (28 tablets) EU/1/07/415/024 (35 tablets) EU/1/07/415/025 (56 tablets) EU/1/07/415/026 (70 tablets)
Zalasta 7,5 mg tabletter er runde, let bikonvekse, svagt gule med mulighed for individuelle gule prikker og påtrykt '7.5'. 
Zalasta 7.5 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 7.5.
Zalasta 10 mg tabletter fås i pakker med 7, 14, 28, 35, 56 og 70 tabletter i blister. 
Zalasta 10 mg tablets: available in boxes of 7, 14, 28, 35, 56 and 70 tablets in blisters.
EU/1/07/415/027 (14 tabletter) EU/1/07/415/028 (28 tabletter) EU/1/07/415/029 (35 tabletter) EU/1/07/415/030 (56 tabletter) EU/1/07/415/031 (70 tabletter) 
EU/1/07/415/027 (14 tablets) EU/1/07/415/028 (28 tablets) EU/1/07/415/029 (35 tablets) EU/1/07/415/030 (56 tablets) EU/1/07/415/031 (70 tablets)
Aspartam Calciumsilicat Magnesiumstearat 
Magnesium stearate
EU/1/07/415/011 (14 tabletter) EU/1/07/415/012 (28 tabletter) EU/1/07/415/013 (35 tabletter) EU/1/07/415/014 (56 tabletter) EU/1/07/415/015 (70 tabletter) 
EU/1/07/415/011 (14 tablets) EU/1/07/415/012 (28 tablets) EU/1/07/415/013 (35 tablets) EU/1/07/415/014 (56 tablets) EU/1/07/415/015 (70 tablets)
Zalasta 10 mg tabletter Blister (OPA/Al/PVC, AI-folie): 7, 14, 28, 35, 56 eller 70 tabletter i æske. 
Zalasta 10 mg tablets Blister (OPA/Alu/PVC, Alu-foil): 7, 14, 28, 35, 56 or 70 tablets in a box.
Blister - Zalasta 10 mg tabletter 
BLISTER FOR ZALASTA 10 mg TABLETS
Blister - Zalasta 20 mg tabletter 
BLISTER FOR ZALASTA 20 mg TABLETS
Karton - Zalasta 5 mg smeltetabletter 
CARTON FOR ZALASTA 5 mgTABLETS
Zalasta 20 mg tabletter Blister (OPA/Al/PVC, AI-folie): 14, 28, 35, 56 eller 70 tabletter i æske. 
Zalasta 20 mg tablets Blister (OPA/Alu/PVC, Alu-foil): 14, 28, 35, 56 or 70 tablets in a box.
Zalasta 20 mg tabletter fås i pakker med 14, 28, 35, 56 og 70 tabletter i blister. 
Zalasta 20 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.
Karton - Zalasta 20 mg tabletter 
CARTON FOR ZALASTA 20 mg TABLETS
Zalasta 7,5 mg smeltetabletter olanzapin 
Zalasta 7.5 mg orodispersible tablets Olanzapine
Zalasta 7,5 mg smeltetablet Hver smeltetablet indeholder 7,5 mg olanzapin. 
Zalasta 7.5 mg orodispersible tablets Each orodispersible tablet contains 7.5 mg olanzapine.
Zalasta 5 mg smeltetablet Tabletterne er gule, runde, let bikonvekse, marmorerede tabletter med mulige, individuelle pletter. 
Zalasta 5 mg orodispersible tablets Tablets are round, slightly biconvex, yellow marbled tablets with possible individual spots.
Zalasta 20 mg tabletter er runde, let bikonvekse, svagt gule med mulighed for individuelle gule prikker og påtrykt '20'. 
Zalasta 20 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 20.
Zalasta 15 mg smeltetablet Tabletterne er gule, runde, let bikonvekse, marmorerede tabletter med mulige, individuelle pletter. 
Zalasta 15 mg orodispersible tablets Tablets are round, slightly biconvex, yellow marbled tablets with possible individual spots.
Zalasta 2,5 mg tabletter Tabletterne er runde, let bikonvekse, svagt gule med mulighed for individuelle gule prikker. 
Zalasta 2.5 mg tablets Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots.
Blister - Zalasta 2,5 mg tabletter 
BLISTER FOR ZALASTA 2.5 mg TABLETS
Karton - Zalasta 10 mg tabletter 
CARTON FOR ZALASTA 10 mg TABLETS
Karton - Zalasta 2,5 mg tabletter 
CARTON FOR ZALASTA 2.5 mg TABLETS
Zalasta 20 mg smeltetablet Hver smeltetablet indeholder 20 mg olanzapin. 
Zalasta 20 mg orodispersible tablets Each orodispersible tablet contains 20 mg olanzapine.
Zalasta 15 mg smeltetabletter olanzapin 
Zalasta 15 mg orodispersible tablets Olanzapine
Blister - Zalasta 15 mg tabletter 
BLISTER FOR ZALASTA 15 mg TABLETS
14 smeltetabletter 28 smeltetabletter 35 smeltetabletter 56 smeltetabletter 70 smeltetabletter 
14 orodispersible tablets 28 orodispersible tablets 35 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets
Zalasta 10 mg smeltetablet Hver smeltetablet indeholder 10 mg olanzapin. 
Zalasta 10 mg orodispersible tablets Each orodispersible tablet contains 10 mg olanzapine.
Zalasta 2,5 mg tabletter fås i pakker med 14, 28, 35, 56 og 70 tabletter i blister. 
Zalasta 2.5 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blister.
Zalasta 7,5 mg tabletter fås i pakker med 14, 28, 35, 56 og 70 tabletter i blister. 
Zalasta 7.5 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.
Blister - Zalasta 7,5 mg tabletter 
BLISTER FOR ZALASTA 7.5 mg TABLETS
1 smeltetablet indeholder 7,5 mg olanzapin. 
Each orodispersible tablet contains 7.5 mg olanzapine.
Zalasta 10 mg smeltetabletter olanzapin 
Zalasta 10 mg orodispersible tablets Olanzapine
Zalasta 5 mg, smeltetabletter Zalasta 7,5 mg, smeltetabletter Zalasta 10 mg, smeltetabletter Zalasta 15 mg, smeltetabletter Zalasta 20 mg, smeltetabletter olanzapin 
Zalasta 5 mg orodispersible tablets Zalasta 7.5 mg orodispersible tablets Zalasta 10 mg orodispersible tablets Zalasta 15 mg orodispersible tablets Zalasta 20 mg orodispersible tablets Olanzapine
Zalasta 5 mg tabletter Blister (OPA/Al/PVC, AI-folie): 14, 28, 35, 56 eller 70 tabletter i æske. 
Zalasta 5 mg tablets Blister (OPA/Alu/PVC, Alu-foil): 14, 28, 35, 56 or 70 tablets in a box.
Zalasta 7,5 mg tabletter Blister (OPA/Al/PVC, AI-folie): 14, 28, 35, 56 eller 70 tabletter i æske. 
Zalasta 7.5 mg tablets Blister (OPA/Alu/PVC, Alu-foil): 14, 28, 35, 56 or 70 tablets in a box.
Zalasta 15 mg tabletter Blister (OPA/Al/PVC, AI-folie): 14, 28, 35, 56 eller 70 tabletter i æske. 
Zalasta 15 mg tablets Blister (OPA/Alu/PVC, Alu-foil): 14, 28, 35, 56 or 70 tablets in a box.
Zalasta 15 mg tabletter fås i pakker med 14, 28, 35, 56 og 70 tabletter i blister. 
Zalasta 15 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.
Zalasta 20 mg smeltetabletter olanzapin 
Zalasta 20 mg orodispersible tablets Olanzapine
Zalasta 10 mg tabletter er runde, let bikonvekse, svagt gule med mulighed for individuelle gule prikker og påtrykt '10'. 
Zalasta 10 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 10.
Zalasta 2,5 mg tabletter Blister (OPA/Al/PVC, AI-folie): 14, 28, 35, 56 eller 70 tabletter i æske. 
Zalasta 2.5 mg tablets Blister (OPA/Alu/PVC, Alu-foil): 14, 28, 35, 56 or 70 tablets in a box.
Zalasta 5 mg tabletter fås i pakker med 14, 28, 35, 56 og 70 tabletter i blister. 
Zalasta 5 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.
EU/1/07/415/047 (14 smeltetabletter) EU/1/07/415/048 (28 smeltetabletter) EU/1/07/415/049 (35 smeltetabletter) EU/1/07/415/050 (56 smeltetabletter) EU/1/07/415/051 (70 smeltetabletter) 
EU/1/07/415/047 (14 orodispersible tablets) EU/1/07/415/048 (28 orodispersible tablets) EU/1/07/415/049 (35 orodispersible tablets) EU/1/07/415/050 (56 orodispersible tablets) EU/1/07/415/051 (70 orodispersible tablets)
1 smeltetablet indeholder 15 mg olanzapin. 
Each orodispersible tablet contains 15 mg olanzapine.
Zalasta 5 mg smeltetabletter olanzapin 
Zalasta 5 mg orodispersible tablets Olanzapine
Karton - Zalasta 20 mg smeltetabletter 
CARTON FOR ZALASTA 20 mg ORODISPERSIBLE TABLETS
EU/1/07/415/042 (14 smeltetabletter) EU/1/07/415/043 (28 smeltetabletter) EU/1/07/415/044 (35 smeltetabletter) EU/1/07/415/045 (56 smeltetabletter) EU/1/07/415/046 (70 smeltetabletter) 
EU/1/07/415/042 (14 orodispersible tablets) EU/1/07/415/043 (28 orodispersible tablets) EU/1/07/415/044 (35 orodispersible tablets) EU/1/07/415/045 (56 orodispersible tablets) EU/1/07/415/046 (70 orodispersible tablets)
Udspilet abdomen 
orodispersible tablet
1 smeltetablet indeholder 10 mg olanzapin. 
Each orodispersible tablet contains 10 mg olanzapine.
1 smeltetablet indeholder 5 mg olanzapin. 
Each orodispersible tablet contains 5 mg olanzapine.
EU/1/07/415/052 (14 smeltetabletter) EU/1/07/415/053 (28 smeltetabletter) EU/1/07/415/054 (35 smeltetabletter) EU/1/07/415/055 (56 smeltetabletter) EU/1/07/415/056 (70 smeltetabletter) 
EU/1/07/415/052 (14 orodispersible tablets) EU/1/07/415/053 (28 orodispersible tablets) EU/1/07/415/054 (35 orodispersible tablets) EU/1/07/415/055 (56 orodispersible tablets) EU/1/07/415/056 (70 orodispersible tablets)
Karton - Zalasta 7,5 mg tabletter 
CARTON FOR ZALASTA 7.5 mg TABLETS
Zalasta 5 mg smeltetablet Hver smeltetablet indeholder 5 mg olanzapin. 
Zalasta 5 mg orodispersible tablets Each orodispersible tablet contains 5 mg olanzapine.
Karton - Zalasta 10 mg smeltetabletter 
CARTON FOR ZALASTA 10 mg ORODISPERSIBLE TABLETS
Blister - Zalasta 10 mg smeltetabletter 
BLISTER FOR ZALASTA 10 mg ORODISPERSIBLE TABLETS
1 smeltetablet indeholder 20 mg olanzapin. 
Each orodispersible tablet contains 20 mg olanzapine.
Karton - Zalasta 15 mg tabletter 
CARTON FOR ZALASTA 15 mg TABLETS
Blister - Zalasta 5 mg tabletter 
BLISTER FOR ZALASTA 5 mg TABLETS
Karton - Zalasta 15 mg smeltetabletter 
CARTON FOR ZALASTA 15 mg ORODISPERSIBLE TABLETS
Svimmelhed Akatisi 
Hepatic impairment
Forhøjede kolesterolniveauer Forhøjede glucoseniveauer Forhøjede triglyceridniveauer Glukosuri Øget appetit 
Glucosuria Increased appetite
Blister - Zalasta 15 mg smeltetabletter 
BLISTER FOR ZALASTA 15 mg ORODISPERSIBLE TABLETS
Blister - Zalasta 20 mg smeltetabletter 
BLISTER FOR ZALASTA 20 mg ORODISPERSIBLE TABLETS
EU/1/07/415/037 (14 smeltetabletter) EU/1/07/415/038 (28 smeltetabletter) EU/1/07/415/039 (35 smeltetabletter) EU/1/07/415/040 (56 smeltetabletter) EU/1/07/415/041 (70 smeltetabletter) 
EU/1/07/415/037 (14 orodispersible tablets) EU/1/07/415/038 (28 orodispersible tablets) EU/1/07/415/039 (35 orodispersible tablets) EU/1/07/415/040 (56 orodispersible tablets) EU/1/07/415/041 (70 orodispersible tablets)
Zalasta 15 mg tabletter er runde, let bikonvekse, svagt gule med mulighed for individuelle gule prikker og påtrykt '15'. 
Zalasta 15 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 15.
Zalasta 15 mg smeltetablet Hver smeltetablet indeholder 15 mg olanzapin. 
Zalasta 15 mg orodispersible tablets Each orodispersible tablet contains 15 mg olanzapine.
Zalasta 5 mg tabletter er runde, let bikonvekse, svagt gule med mulighed for individuelle gule prikker og påtrykt '5'. 
Zalasta 5 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 5.
EU/1/07/415/032 (14 smeltetabletter) EU/1/07/415/033 (28 smeltetabletter) EU/1/07/415/034 (35 smeltetabletter) EU/1/07/415/035 (56 smeltetabletter) EU/1/07/415/036 (70 smeltetabletter) 
EU/1/07/415/032 (14 orodispersible tablets) EU/1/07/415/033 (28 orodispersible tablets) EU/1/07/415/034 (35 orodispersible tablets) EU/1/07/415/035 (56 orodispersible tablets) EU/1/07/415/036 (70 orodispersible tablets)
Yderligere information om Jivi findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Jivi. 
Further information on Jivi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Jivi.
Andre oplysninger om Jivi 
Other information about Jivi
Som for alle lægemidler bliver data vedrørende brug af Jivi løbende overvåget. 
As for all medicines, data on the use of Jivi are continuously monitored.
Patienten eller dennes omsorgsperson kan selv injicere Jivi derhjemme efter at have fået passende oplæring. 
Patients or their carers may be able to inject Jivi themselves at home once they have been trained appropriately.
For mere information om brug af Jivi, se indlægssedlen eller kontakt lægen eller apotekspersonalet. 
For more information about using Jivi, see the package leaflet or contact your doctor or pharmacist.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Jivi? 
What measures are being taken to ensure the safe and effective use of Jivi?
Den hyppigste bivirkning ved Jivi (som optræder hos mere end 1 ud af 10 patienter) er hovedpine. 
The most common side effect with Jivi (which may affect more than 1 in 10 people) is headache.
Jivi kan anvendes hos voksne og børn i alderen 12 år og derover, som tidligere er blevet behandlet. 
Jivi can be used in adults and children from 12 years of age who have been treated previously.
Da dette potentielt kan medføre problemer, især hos børn under 12 år, er Jivi kun godkendt til voksne og børn i alderen 12 år og derover. 
Since this could potentially cause problems especially in children below 12 years of age, Jivi is only approved for use in adults and children from 12 years of age.
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Jivi opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
The European Medicines Agency decided that Jivi's benefits are greater than its risks and it can be authorised for use in the EU.
Bivirkninger rapporteret for Jivi vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Jivi are carefully evaluated and any necessary action taken to protect patients.
Dosis og hyppighed af behandlingen afhænger af, om det skal anvendes til behandling eller til forebyggelse af blødning, sygdommens sværhedsgrad, blødningsomfang og sted samt patientens tilstand og vægt. 
The dose and frequency of treatment depend on whether it is used to treat or prevent bleeding, as well as on the severity of the haemophilia, the extent and location of the bleeding and the patient's condition and weight.
Allergiske reaktioner er almindelige ved Jivi (kan forekomme hos op til 1 ud af 10 patienter) og kan omfatte hævelse, brændende og stikkende fornemmelse på injektionsstedet, kulderystelser, rødme, prikkende fornemmelse, kløende udslæt, hovedpine, nældefeber, lavt blodtryk, sløvhed, kvalme og opkastning, rastløshed, hurtig hjerterytme, trykken for brystet og hvæsende vejrtrækning. 
Hypersensitivity (allergic) reactions are common with Jivi (affecting up to 1 in 10 people) and may include swelling, burning and stinging at the injection site, chills, flushing, tingling, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a rapid heartbeat, tightness of the chest and wheezing.
En oversigt over Jivi, og hvorfor det er godkendt i EU 
An overview of Jivi and why it is authorised in the EU
Hvad er Jivi, og hvad anvendes det til? 
What is Jivi and what is it used for?
Jivi blev bedømt som godt eller fremragende til at standse blødning i alle de kirurgiske indgreb. 
Jivi was rated good or excellent at stopping bleeding in all surgeries.
Hvorfor blev Jivi godkendt i EU? 
Why is Jivi authorised in the EU?
Hvilke risici er der forbundet med Jivi? 
What are the risks associated with Jivi?
Jivi udleveres kun efter recept, og behandlingen bør iværksættes under opsyn af en læge med erfaring i behandling af hæmofili. 
Jivi can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.
Jivi indgives ved injektion i en blodåre. 
Jivi is given by injection into a vein.
Virksomheden, der markedsfører Jivi, skal gennemføre en undersøgelse af de mulige virkninger af PEG-ophobning i hjernens plexus choroideus og andre organer. 
The company that markets Jivi will conduct a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other organs.
Laboratoriestudier viser imidlertid, at PEG, som indgår i det aktive stof i Jivi, kan ophobes i kroppen, herunder i en struktur i hjernen kaldet plexus choroideus, efter langvarig behandling. 
However, laboratory studies show that PEG, which is part of the active substance in Jivi, may accumulate in the body, including in a structure in the brain called the choroid plexus, following long-term treatment.
Det aktive stof i Jivi, damoctocog alfa pegol, virker på samme måde som kroppens faktor VIII. 
The active substance in Jivi, damoctocog alfa pegol, works in the same way as the body's factor VIII.
Jivi må ikke gives til patienter, som er allergiske over for muse- eller hamsterproteiner. 
Jivi must not be used in patients with allergy to mouse or hamster proteins.
Jivi er påvist at være effektivt til at reducere antallet af blødningsepisoder hos patienter med svær hæmofili og standse blødninger, når de opstår. 
Jivi has been shown to be effective at reducing the number of bleeding episodes in patients with severe haemophilia and stopping bleeding when it occurs.
I en anden del af studiet fik 17 patienter Jivi til at kontrollere blødning under 20 større kirurgiske indgreb. 
In a second part of the study, 17 patients received Jivi to control bleeding during 20 major surgeries.
Undersøgelser viser, at Jivi er effektivt til at forebygge og behandle blødningsepisoder hos patienter med hæmofili A, og dets sikkerhed er sammenlignelig med andre faktor VIII-lægemidler. 
Studies show that Jivi is effective at preventing and treating bleeding episodes in patients with haemophilia A and its safety is comparable to that of other factor VIII products.
En del af det aktive stof er et stof kaldet polyethylenglycol (PEG), der bidrager til, at lægemidlet bliver i kroppen længere og dermed virker længere. 
Part of the active substance is a substance called polyethylene glycol, ‘PEG', which is included to help the medicine remain in the body for longer and thereby prolong its action.
Det erstatter den manglende faktor VIII og medvirker derfor til blodets størkning, så der opnås midlertidig kontrol med blødningsforstyrrelsen. 
It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of the bleeding disorder.
Efter behandling med faktor VIII-lægemidler, herunder Jivi, kan nogle patienter danne antistoffer mod faktor VIII, hvilket medfører, at lægemidlet ikke længere virker effektivt, og at kontrollen med blødning svigter. 
Following treatment with factor VIII products, including Jivi, some patients may develop inhibitors (antibodies) against factor VIII, preventing the medicine from working effectively and resulting in a loss of bleeding control.
De 20 patienter, der fik Jivi til behandling af blødninger, når de opstod, havde ca. 23 blødningsepisoder om året. 
The 20 patients who were given Jivi for treating bleeding when it occurred had around 23 bleeding episodes a year.
Jivi indeholder det aktive stof damoctocog alfa pegol. 
Jivi contains the active substance damoctocog alfa pegol.
I et andet studie med 61 børn under 12 år reducerede Jivi givet som forebyggende behandling antallet af blødningsepisoder til ca. tre episoder om året. 
In a second study in 61 children aged below 12 years, Jivi given as preventive treatment reduced the number of bleeding episodes to around 3 episodes a year.
Jivi er et lægemiddel til behandling og forebyggelse af blødning hos patienter med den arvelige blødningsforstyrrelse hæmofili A, der skyldes mangel på blodstørkningsproteinet faktor VIII. 
Jivi is a medicine used to treat and prevent bleeding in patients with haemophilia A, an inherited bleeding disorder caused by lack of a clotting protein called factor VIII.
I et studie med 134 patienter fra 12 år og opefter havde 114 patienter, som fik Jivi som forebyggende behandling, ca. to blødningsepisoder om året. 
In a study of 134 patients from 12 years of age, 114 patients given Jivi as a preventive treatment had around 2 bleeding episodes per year.
Hvordan anvendes Jivi? 
How is Jivi used?
Hvilke fordele viser studierne, at der er ved Jivi? 
What benefits of Jivi have been shown in studies?