natgillin/translations-raw huggingface dataset:
De hyppigst rapporterede (set hos ≥1 % af patienter) bivirkninger, som blev set i forbindelse med anvendelse af olanzapin i kliniske forsøg, var døsighed og vægtøgning, eosinofili, forhøjede niveauer af prolaktin, kolesterol, glucose og triglycerider (se pkt.
The most frequently (seen in ≥ 1% of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema.
Prægelatineret majsstivelse Majsstivelse
Lactose monohydrate Powdered cellulose Pregelatinised maize starch Maize starch
Dette lægemiddel indeholder 0,50 mg aspartam pr. 5 mg smeltetablet.
This medicine contains 0.50 mg aspartame in each 5 mg orodispersible tablet.
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
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
Zalasta 20 mg tabletter olanzapin
Zalasta 20 mg tablets Olanzapine
Din læge vil fortælle dig, hvor mange Zalasta tabletter, du skal tage og i hvor lang tid, du skal tage dem. Dagsdosis for Zalasta er mellem 5 mg og 20 mg. Konsulter din læge, hvis dine symptomer vender tilbage, men stop ikke med at tage Zalasta medmindre, din læge siger det.
Consult your doctor if your symptoms return but do not stop taking Zalasta unless your doctor tells you to.
Indehaveren af markedsføringstilladelsen KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenien
Marketing Authorisation Holder KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
1 tablet indeholder 2,5 mg olanzapin.
Each tablet contains 2.5 mg olanzapine.
4 KLINISKE OPLYSNINGER
CLINICAL PARTICULARS
Zalasta 2,5 mg tabletter olanzapin
Zalasta 2.5 mg tablets Olanzapine
Zalasta 15 mg tabletter Hver tablet indeholder 15 mg olanzapin.
Zalasta 15 mg tablets Each tablet contains 15 mg olanzapine.
Det skal du vide, før du begynder at tage Zalasta Sådan skal du tage Zalasta Bivirkninger
What Zalasta is and what it is used for What you need to know before you take Zalasta How to take Zalasta
Zalasta 5 mg tabletter Hver tablet indeholder 5 mg olanzapin.
Zalasta 5 mg tablets Each tablet contains 5 mg olanzapine.
Zalasta 2,5 mg tabletter Hver tablet indeholder 2,5 mg olanzapin.
Zalasta 2.5 mg tablets Each tablet contains 2.5 mg olanzapine.
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.