natgillin/translations-raw huggingface dataset:
De mest almindelige bivirkninger i kontrollerede undersøgelser med supplerende behandlinger var somnolens, svimmelhed og anorexi.
The most common adverse reactions in controlled adjunctive-therapy studies were somnolence, dizziness and anorexia.
Bivirkninger forbundet med Zonegran registreret fra kliniske undersøgelser og overvågning efter markedsføring er anført i nedenstående tabel.
Adverse reactions associated with Zonegran obtained from clinical studies and post-marketing surveillance are tabulated below.
Meget almindelig Almindelig Ikke almindelig Sjælden Meget sjælden
very common common uncommon rare very rare
≥ 1/ 10 ≥ 1/ 100 < 1/ 10 ≥ 1/ 1. 000 < 1/ 100 ≥ 1/ 10. 000 < 1/ 1. 000 < 1/ 10. 000 herunder enkeltstående indberetninger
≥ 1/ 10 ≥ 1/ 100 < 1/ 10 ≥ 1/ 1,000 < 1/ 100 ≥ 1/ 10,000 < 1/ 1,000 < 1/ 10,000 including isolated reports
6 Systemorgan - klasser (MedDRA terminologi)
System Organ Class (MedDRA terminology)
Ikke almindelig
Very Rare
Meget sjælden
Infections and infestation
Infektioner og parasitære sygdomme
Pneumonia Urinary tract infection
Pneumoni Urinvejsinfek- tion
6 System Organ Class (MedDRA terminology)
Blod - og lymfesystem
Very Common
Ekkymose
Very Rare
Agranulocytose Aplastisk anæmi Leucocytose Leucopeni Lymphadenopathi Pancytopeni Trombocytopeni
Agranulocytosis Aplastic anaemia Leucocytosis Leucopoenia Lymphadenopathy Pancytopenia, Thrombocytopenia
Agitation Irritabilitet Konfusions - tilstande Depression
Agitation Irritability Confusional state Depression
Affektlabilitet Angst Insomni Psykotisk tilstand
Affect lability Anxiety Insomnia Psychotic disorder
Vrede Aggression Suicidaltanker Selvmordsforsøg
Anger Aggression Suicidal ideation Suicide attempt
Nervesystemet
Nervous system disorders Eye disorders Respiratory, thoracic and mediastinal disorders
Ataxi Svimmelhed Hukommel - sesbesvær Somnolens
Ataxia Dizziness Memory impairment Somnolence Diplopia
Amnesi Coma Grand mal anfald Myasthenisk syndrom Malignt neuroleptisk syndrom Status epilepticus
Amnesia Coma Grand mal seizure Myasthenic syndrome Neuroleptic malignant syndrome Status epilepticus Dyspnoea Pneumonia aspiration Respiratory disorder
Øjne Luftveje, thorax og mediastinum
Gastrointestinal disorders
Dyspnø Aspirations - pneumoni Respirations - problemer
Abdominal pain Constipation Diarrhoea Dyspepsia Nausea
Cholecystitis Cholelithiasis
Cholecystitis Cholelithiasis
Anhidrose Erythema multiforme Pruritus Stevens- Johnson syndrom
Anhidrosis Erythema multiforme Pruritis Stevens-Johnson syndrome
7 Systemorgan - klasser (MedDRA terminologi)
Renal and urinary disorders General disorders and administration site conditions
Meget almindelig
Nephrolithiasis Fatigue Influenza-like illness Pyrexia
Almindelig
Calculus urinary
Ikke almindelig
Hydronephrosis Renal failure Urine abnormality
Meget sjælden
7 System Organ Class (MedDRA terminology)
Nyre og urinveje
Very Common
Nephrolithiasis
Common
Sten i urinvejene
Uncommon
Hydronephrose Nyresvigt Abnorm urinsammen - sætning
Very Rare
Nedsat bikarbonat
Decreased bicarbonate
Øget creatinfosfokinase i blodet Øget kreatinin i blodet Øget carbamid i blodet Abnorme leverfunktions - prøver
Blood creatine phosphokinase increased Blood creatinine increased Blood urea increased Liver function tests abnormal
Desuden har der været isolerede tilfælde af pludselig uventet død hos epilepsipatienter (SUDEP), der har fået Zonegran.
In addition there have been isolated cases of Sudden Unexplained Death in Epilepsy Patients (SUDEP) receiving Zonegran.
Yderligere oplysninger om særlige populationer:
Additional information on special populations:
Gennemgang af data efter markedsføringen tyder på, at patienter på 65 år og derover har en højere hyppighed end den generelle befolkning af følgende hændelser:
Review of post-marketing data suggests that patients aged 65 years or older report a higher frequency than the general population of the following events:
Stevens Johnson- syndrom (SJS) og lægemiddelinduceret overfølsomhedssyndrom (DIHS).
Stevens-Johnson syndrome (SJS) and Drug Induced Hypersensitivity syndrome (DIHS).
I andre tilfælde blev overdoseringen efterfulgt af symptomer som somnolens, kvalme, gastritis, nystagmus, myoklonier, koma, bradycardi, nedsat nyrefunktion, hypotension og respirationsdepression.
In other cases, the overdose was followed by symptoms such as somnolence, nausea, gastritis, nystagmus, myoclonus, coma, bradycardia, reduced renal function, hypotension and respiratory depression.
Patienten blev komatøs og havde respirationsdepression, men kom til bevidsthed fem dage senere og havde ingen følgevirkninger.
A very high plasma concentration of 100.1 μ g/ ml zonisamide was recorded approximately 31 hours after a patient took an overdose of Zonegran and clonazepam; the patient became comatose and had respiratory depression, but recovered consciousness five days later and had no sequelae.
8 zonisamid hos en patient med nedsat nyrefunktion og det kan måske overvejes som behandling af overdosering, hvis det klinisk er indiceret.
Although not formally studied for the treatment of overdose, haemodialysis reduced plasma concentrations of zonisamide in a patient with reduced renal function, and may be considered as treatment of overdose if clinically indicated.
Det er et antiepileptikum med en svag kulsyreanhydrasevirkning in- vitro.
It is an anti-epileptic medicine with weak carbonic anhydrase activity in-vitro.
Det er kemisk ikke i familie med andre antiepileptika.
It is chemically unrelated to other anti-epileptic agents.
Antiepileptika, ATC- kode:
Anti-epileptics, ATC code:
Effekten af Zonegran er blevet påvist i 4 dobbeltblindede, placebo- kontrollerede undersøgelser i perioder på op til 24 uger med dosering enten en eller to gange daglig.
These studies show that the median
Disse undersøgelser viser, at den mediane reduktion i partiel krampefrekvens er relateret til Zonegrandosis med vedvarende effekt i doser på 300- 500 mg daglig.
8 reduction in partial seizure frequency is related to Zonegran dose with sustained efficacy at doses of 300-500 mg per day.
Zonisamids antikonvulsive virkning er blevet vurderet i forskellige modeller, hos flere arter med inducerede eller medfødte kramper og zonisamid ser ud til at virke som et bredspektret antiepileptikum i disse modeller.
The anticonvulsant activity of zonisamide has been evaluated in a variety of models, in several species with induced or innate seizures, and zonisamide appears to act as a broad-spectrum anti-epileptic in these models.
Zonisamid forebygger maksimale elektroshockkramper og begrænser spredningen af kramper herunder udbredelsen af kramper fra cortex til subcorticale strukturer og undertrykker epileptogen fokusaktivitet.
Zonisamide prevents maximal electroshock seizures and restricts seizure spread, including the propagation of seizures from cortex to sub-cortical structures and suppresses epileptogenic focus activity.
I modsætning til phenytoin og carbamazepin virker zonisamid imidlertid fortrinsvis på kramper, der udgår fra cortex.
Unlike phenytoin and carbamazepine however, zonisamide acts preferentially on seizures originating in the cortex.
Zonisamids virkningsmekanisme er ikke fuldt ud klarlagt, men det synes at virke på spændingsfølsomme natrium - og calciumkanaler, hvorved det afbryder synkroniseret neuronfyring og dermed reducerer spredningen af krampeudladninger og afbryder efterfølgende epileptisk aktivitet.
The mechanism of action of zonisamide is not fully elucidated, but it appears to act on voltage-sensitive sodium and calcium channels, thereby disrupting synchronised neuronal firing, reducing the spread of seizure discharges and disrupting subsequent epileptic activity.
Zonisamid har også en modulerende virkning på GABA- medieret neuronhæmning.
Zonisamide also has a modulatory effect on GABA-mediated neuronal inhibition.
Zonisamid absorberes næsten fuldstændigt efter peroral indgift og når almindeligvis maksimal serum - eller plasmakoncentration i løbet af 2 til 5 timer efter indgift.
Zonisamide is almost completely absorbed after oral administration, generally reaching peak serum or plasma concentrations within 2 to 5 hours of dosing.
First- pass metabolismen menes at være negligeabel.
The first-pass metabolism is believed to be negligible.
Den absolutte biotilgængelighed skønnes at være omkring 100%.
Absolute bioavailability is estimated to be approximately 100%.
Den perorale biotilgængelighed påvirkes ikke af fødeindtagelse, selv om den maksimale plasma - og serumkoncentration kan blive forsinket.
Oral bioavailability is not affected by food, although peak plasma and serum concentrations may be delayed.
Zonisamid AUC og Cmax værdierne steg næsten lineært efter en enkelt dosis i et doseringsområde på 100- 800 mg en gang daglig og efter multiple doser i et doseringsområde på 100 – 400 mg en gang daglig.
Zonisamide AUC and Cmax values increased almost linearly after single dose over the dose range of 100-800 mg and after multiple doses over the dose range of 100-400 mg once daily.
In vitro undersøgelser viser, at dette ikke påvirkes af tilstedeværelsen af forskellige antiepileptika (dvs. phenytoin, phenobarbital, carbamazepin og natriumvalproat).
Zonisamide is 40 - 50% bound to human plasma proteins, with in vitro studies showing that this is unaffected by the presence of various antiepileptic medicinal products (i. e., phenytoin, phenobarbitone, carbamazepine, and sodium valproate).
Det åbenbare fordelingsvolumen er omkring 1, 1 – 1, 7 l/ kg hos voksne tydende på, at zonisamid i udstrakt grad fordeles til vævene.
The apparent volume of distribution is about 1.1 – 1.7 l/ kg in adults indicating that zonisamide is extensively distributed to tissues.
Erytrocyt/ plasma ratio er omkring 15 ved lave koncentrationer og omkring 3 ved højere koncentrationer.
Erythrocyte/ plasma ratios are about 15 at low concentrations and about 3 at higher concentrations.
9 Zonisamid metaboliseres primært af CYP3A4 via en reduktiv spaltning af benzisoxazolringen i moderstoffet, så der dannes 2- sulphamoylacetylphenol (SMAP) samt også ved N- acetylering.
Zonisamide is metabolised primarily through reductive cleavage of the benzisoxazole ring of the parent drug by CYP3A4 to form 2-sulphamoylacetylphenol (SMAP) and also by N-acetylation.
60 timer, når CYP3A4- inducerende stoffer ikke er til stede.
Apparent clearance of zonisamide at steady-state after oral administration is about 0.70 l/ h and the terminal elimination half-life is about 60 hours in the absence of CYP3A4 inducers.
Svingninger i serum - eller plasmakoncentrationer i løbet af et dosisinterval er små (< 30%).
Fluctuation in serum or plasma concentrations over a dosing interval is low (< 30%).
3, 5 ml/ min).
The main route of excretion of zonisamide metabolites and unchanged drug is via the urine.
Omkring 15 - 30% af dosis elimineres uomdannet.
Renal clearance of unchanged zonisamide is relatively low (approximately 3.5 ml/ min); about 15 - 30% of the dose is eliminated unchanged.
Hos patienter med nedsat nyrefunktion var den renale clearance af enkeltdoser af zonisamid positivt korreleret med creatininclearance.
9 In subjects with renal impairment, renal clearance of single doses of zonisamide was positively correlated with creatinine clearance.
4. 2.).
The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance < 20 ml/ min (see also section 4.2.).
Patienter med nedsat leverfunktion:
Patients with an impaired liver function:
Zonisamids farmakokinetik hos patienter med nedsat leverfunktion er ikke undersøgt tilstrækkeligt.
The pharmacokinetics of zonisamide in patients with impaired liver function have not been adequately studied.
Der blev ikke observeret klinisk signifikante forskelle i farmakokinetikken mellem unge (i alderen 21- 40 år) og ældre (65- 75 år).
No clinically significant differences were observed in the pharmacokinetics between young (aged 21-40 years) and elderly (65-75 years).
Unge (12- 18 år):
Adolescents (12-18 years):
Begrænsede data tyder på, at farmakokinetikken hos unge, som doseres til ligevægt med 1, 7 eller 12 mg/ kg daglig i delte doser, er den samme, som blev observeret hos voksne efter korrektion for legemsvægt.
Limited data indicate that pharmacokinetics in adolescents dosed to steady state at 1, 7 or 12 mg/ kg daily, in divided doses, are similar to those observed in adults, after adjustment for bodyweight.
Der er ikke defineret et klart forhold mellem dosis- koncentration- respons for Zonegran.
No clear Zonegran dose-concentration-response relationship has been defined.
Når man sammenligner det samme dosisniveau vil patienter med en større total legemsvægt vise sig at have lavere ligevægtskoncentration i serum, men denne virkning synes at være relativt beskeden.
When comparing the same dose level, subjects of higher total body weight appear to have lower steady-state serum concentrations, but this effect appears to be relatively modest.
Alder (≥ 12 år) og køn har ikke efter korrektion for virkningen af legemsvægten nogen tilsyneladende virkning på zonisamideksponeringen hos epilepsipatienter under ligevægtsdosering.
Age (≥ 12 years) and gender, after adjustment for body weight effects, have no apparent effect on zonisamide exposure in epileptic patients during steady-state dosing.
Fund, der ikke blev iagttaget i kliniske undersøgelser, men blev set hos hunde ved lignende eksponeringsniveauer svarende til klinisk anvendelse, var leverskader (forstørrelse, mørkebrun misfarvning, let hepatocytforstørrelse med koncentriske lamellære legemer i cytoplasmaet og cytoplasmatisk vakuolisering) forbundet med øget metabolisme.
Findings not observed in clinical studies, but seen in the dog at exposure levels similar to clinical use, were liver changes (enlargement, dark-brown discolouration, mild hepatocyte enlargement with concentric lamellar bodies in the cytoplasm and cytoplasmic vacuolation) associated with increased metabolism.
10 Kapselindhold:
Capsule contents:
Mikrokrystallinsk cellulose Hydrogeneret vegetabilsk olie Natriumlaurilsulfat.
Microcrystalline cellulose Hydrogenated vegetable oil Sodium laurilsulfate.
Kapselskaller:
Capsule shells:
Gelatine Titandioxid (E171) Shellac Propylenglycol Kaliumhydroxid Sort jernoxid (E172).
Gelatin Titanium dioxide (E171) Shellac Propylene glycol Potassium hydroxide Black iron oxide (E172).
6. 3 Opbevaringstid
10 6.3 Shelf life
PVC/ PCTFE/ aluminium blisterkort, pakninger med 14, 28, 56 og 84 hårde kapsler.
PVC/ PCTFE/ aluminium blisters, packs of 14, 28, 56, and 84 hard capsules.
Eisai Limited 3 Shortlands London W6 8EE Storbritannien
Eisai Limited 3 Shortlands London W6 8EE United Kingdom
11 10. marts 2005
10 March 2005
Zonegran 50 mg kapsel, hård.
Zonegran 50 mg hard capsules.
Hver Zonegran- kapsel, hård indeholder 50 mg zonisamid.
Each Zonegran hard capsule contains 50 mg of zonisamide.
En hvid uigennemsigtig underdel og en grå uigennemsigtig overdel hvorpå der er trykt logo og “ ZONEGRAN 50 ” i sort.
A white opaque body and a grey opaque cap printed with a logo and “ ZONEGRAN 50” in black.
Sikkerheden og effekten hos børn og unge under 18 år er ikke fastslået..
The safety and effectiveness in children and adolescents under 18 years have not been established.
13 Patienter med nedsat nyrefunktion
12 Patients with renal impairment
Alvorlige immunbaserede bivirkninger, som har forbindelse med lægemidler indeholdende en sulfonamidgruppe, omfatter udslæt, allergisk reaktion og alvorlige hæmatologiske sygdomme inklusive aplastisk anæmi, der i meget sjældne tilfælde kan være fatalt.
Serious immune based adverse reactions that are associated with medicinal products containing a sulphonamide group include rash, allergic reaction and major haematological disturbances including aplastic anaemia, which very rarley can be fatal.
14 Der er rapporteret tilfælde med agranulocytose, trombocytopeni, leukopeni, aplastisk anæmi, pancytopeni og leukocytose.
Cases of agranulocytosis, thrombocytopenia, leukopenia, aplastic anaemia, pancytopenia and leucocytosis have been reported.
Nyresten har forekommet hos patienter behandlet med Zonegran.
13 Kidney stones have occurred in patients treated with Zonegran.
Zonegrans mulighed for at indvirke på andre lægemidler
14 Potential for Zonegran to affect other medicinal products
Behovet for antiepileptisk
The need for anti- epileptic treatment should be reviewed in patients planning to become pregnant.
16 behandling bør overvejes hos patienter, der planlægger at blive gravide.
Specialist advice should be given to women who are likely to become pregnant in order to consider the optimal treatment during pregnancy.
Hvis Zonegran ordineres, anbefales omhyggelig kontrol.
Women of childbearing potential should be given specialist
Kvinder i den fødedygtige alder bør have rådgivning af en specialist med hensyn til mulige virkninger af Zonegran på fostret, og risikoen bør diskuteres med patienten i relation til fordelene, inden behandlingen påbegyndes.
15 advice regarding possible effects of Zonegran on the foetus and the risk should be discussed with the patient in relation to the benefits before starting treatment.
17 Systemorgan - klasser (MedDRA terminologi)
16 System Organ Class (MedDRA terminology)
Pneumoni Urinvejsinfek- tion
Pneumonia Urinary tract infection
Dyspnø Aspirationspneum oni Respirations - problemer
Abdominal pain Constipation Diarrhoea Dyspepsia Nausea
18 Systemorgan - klasser (MedDRA terminologi)
17 System Organ Class (MedDRA terminology)
Nyre og urinveje
Renal and urinary disorders General disorders and administration site conditions
Nephrolithiasis
Nephrolithiasis Fatigue Influenza-like illness Pyrexia
Sten i urinvejene
Calculus urinary
Hydronephrose Nyresvigt Abnorm urinsammen - sætning
Hydronephrosis Renal failure Urine abnormality
19 Behandling
Treatment
Zonisamid er et benzisoxazolderivat.
18 Zonisamide is a benzisoxazole derivative.
Effekten af Zonegran er blevet påvist i 4 dobbeltblindede, placebo- kontrollerede undersøgelser i perioder på op til 24 uger med dosering enten en eller to gange daglig.
Efficacy has been demonstrated with Zonegran in 4 double-blind, placebo-controlled studies of periods of up to 24 weeks with either once or twice daily dosing.
Disse undersøgelser viser, at den mediane reduktion i partiel krampefrekvens er relateret til Zonegrandosis med vedvarende effekt i doser på 300- 500 mg daglig.
These studies show that the median reduction in partial seizure frequency is related to Zonegran dose with sustained efficacy at doses of 300-500 mg per day.
20 Fordeling
Distribution
Zonisamid metaboliseres primært af CYP3A4 via en reduktiv spaltning af benzisoxazolringen i moderstoffet, så der dannes 2- sulphamoylacetylphenol (SMAP) samt også ved N- acetylering.
Zonisamide is metabolised primarily through reductive cleavage of the benzisoxazole ring of the parent drug by CYP3A4 to form 2-sulphamoylacetylphenol (SMAP) and also by N-acetylation.
60 timer, når CYP3A4- inducerende stoffer ikke er til stede.
19 Apparent clearance of zonisamide at steady-state after oral administration is about 0.70 l/ h and the terminal elimination half-life is about 60 hours in the absence of CYP3A4 inducers.
21 Zonisamid var ikke genotoksisk og har intet carcinogent potentiale.
Zonisamide was not genotoxic and has no carcinogenic potential.
Gelatine Titandioxid (E171) Shellac Propylenglycol Kaliumhydroxid Sort jernoxid (E172).
20 Shellac Propylene glycol Potassium hydroxide Black iron oxide (E172).
PVC/ PCTFE/ aluminium blisterkort, pakninger med 14, 28, 56 og 84 hårde kapsler.
PVC/ PCTFE/ aluminium blisters, packs of 14, 28, 56 and 84 hard capsules.
22 8.
8.
Zonegran 100 mg kapsel, hård.
Zonegran 100 mg hard capsules.
Hver Zonegran- kapsel, hård indeholder 100 mg zonisamid.
Each Zonegran hard capsule contains 100 mg of zonisamide.
En hvid uigennemsigtig underdel og en rød uigennemsigtig overdel hvorpå der er trykt logo og “ ZONEGRAN 100 ” i sort.
A white opaque body and a red opaque cap printed with a logo and “ ZONEGRAN 100” in black.
24 Patienter med nedsat nyrefunktion
22 Patients with renal impairment
25 Der er rapporteret tilfælde med agranulocytose, trombocytopeni, leukopeni, aplastisk anæmi, pancytopeni og leukocytose.
Cases of agranulocytosis, thrombocytopenia, leukopenia, aplastic anaemia, pancytopenia and leucocytosis have been reported.
Nyresten har forekommet hos patienter behandlet med Zonegran.
23 Kidney stones have occurred in patients treated with Zonegran.
Virkning af Zonegran på cytochrom P450 enzymes
Effect of Zonegran on cytochrome P450 enzyme
Zonegrans mulighed for at indvirke på andre lægemidler
24 Potential for Zonegran to affect other medicinal products
27 behandling bør overvejes hos patienter, der planlægger at blive gravide.
Specialist advice should be given to women who are likely to become pregnant in order to consider the optimal treatment during pregnancy.
Kvinder i den fødedygtige alder bør have rådgivning af en specialist med hensyn til mulige virkninger af Zonegran på fostret, og risikoen bør diskuteres med patienten i relation til fordelene, inden behandlingen påbegyndes.
25 advice regarding possible effects of Zonegran on the foetus and the risk should be discussed with the patient in relation to the benefits before starting treatment.
28 Systemorgan - klasser (MedDRA terminologi)
26 System Organ Class (MedDRA terminology)
Dyspnø Aspirationspneumoni Respirations - problemer
Abdominal pain Constipation Diarrhoea Dyspepsia Nausea
Nyre og urinveje
Rhabdomyolysis
29 Systemorgan - klasser (MedDRA terminologi)
27 System Organ Class (MedDRA terminology)
Almene symptomer og reaktioner på administrations - stedet
Nephrolithiasis Fatigue Influenza-like illness Pyrexia
Træthed Influenzalignende sygdom Feber
Hydronephrosis Renal failure Urine abnormality
Øget creatinfosfokinase i blodet Øget kreatinin i blodet Øget carbamid i blodet Abnorme leverfunktionsprøver
Blood creatine phosphokinase increased Blood creatinine increased Blood urea increased Liver function tests abnormal
30 Zonisamid er et benzisoxazolderivat.
28 Zonisamide is a benzisoxazole derivative.
Det er et antiepileptikum med en svag kulsyreanhydrasevirkning in vitro.
It is an anti-epileptic medicine with weak carbonic anhydrase activity in-vitro.
31 Elimination
Elimination
60 timer, når CYP3A4- inducerende stoffer ikke er til stede.
29 Apparent clearance of zonisamide at steady-state after oral administration is about 0.70 l/ h and the terminal elimination half-life is about 60 hours in the absence of CYP3A4 inducers.
32 Kapselskaller:
30 Capsule shells:
Gelatine Titandioxid (E171) Allurarødt AC (E129) Sunset yellow FCF (E110) Shellac Propylenglycol Kaliumhydroxid Sort jernoxid (E172).
Gelatin Titanium dioxide (E171) Allura red AC (E129) Sunset yellow FCF (E110) Shellac Propylene glycol Potassium hydroxide Black iron oxide (E172).
PVC/ PCTFE/ aluminium blisterkort, pakninger med 28, 56, 84, 98 og 196 hårde kapsler.
PVC/ PCTFE/ aluminium blisters, packs of 28, 56, 84, 98 and 196 hard capsules.
EU/ 1/ 04/ 307/ 006 EU/ 1/ 04/ 307/ 004 EU/ 1/ 04/ 307/ 0011 EU/ 1/ 04/ 307/ 007 EU/ 1/ 04/ 307/ 008
EU/ 1/ 04/ 307/ 006 EU/ 1/ 04/ 307/ 004 EU/ 1/ 04/ 307/ 011 EU/ 1/ 04/ 307/ 007 EU/ 1/ 04/ 307/ 008
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
31 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
35 A FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
33 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Eisai Manufacturing Ltd Titan Court 3 Bishop Square Hatfield Hertfordshire AL10 9NE Storbritannien
Eisai Limited 3 Shortlands London W6 8EE United Kingdom
38 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Farvestoffer E171, E172
Colouring agents E171, E172
Oral anvendelse Læs indlægssedlen før brug
Oral use Read the package leaflet before use
ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF REACH AND SIGHT OF CHILDREN
(MM/ ÅÅÅÅ)
EXP (MM/ YYYY)
Eisai Ltd., 3 Shortlands, London W6 8EE, Storbritannien
Eisai Ltd., 3 Shortlands, London W6 8EE, United Kingdom.