natgillin/translations-raw huggingface dataset:
I et forsøg hos forsøgspersoner med Gilbert- Meulengrachts sygdom blev den påviselige gennemsnitlige clearance reduceret med 32% i forhold til den raske kontrolgruppe, men værdierne ligger inden for det område, der gælder for den almene befolkning.
In a study of subjects with Gilbert's Syndrome, mean apparent clearance was reduced by 32% compared with normal controls but the values are within the range for the general population.
4. 2).
Mean half-life is reduced to approximately 14 hours when given with glucuronidation-inducing medicinal products such as carbamazepine and phenytoin and is increased to a mean of approximately 70 hours when co-administered with valproate alone (see section 4.2).
70 Særlige patientpopulationer
Special patient populations
Børn Clearance justeret for legemsvægt er højere hos børn end hos voksne, og værdierne er højest hos børn under fem år.
Children Clearance adjusted for body weight is higher in children than in adults with the highest values in children under five years.
4. 2).
The half-life of lamotrigine is generally shorter in children than in adults with a mean value of approximately 7 hours when given with enzyme-inducing medicinal products such as carbamazepine and phenytoin and increasing to mean values of 45 to 50 hours when co-administered with valproate alone (see section 4.2).
Spædbørn i alderen 2 til 26 måneder Hos 143 børn i alderen 2 til 26 måneder, som vejede fra 3 til 16 kg, var clearance nedsat sammenlignet med ældre børn med samme legemsvægt, der modtog samme perorale doser pr. kilo legemsvægt som børn over 2 år.
69 Infants aged 2 to 26 months In 143 paediatric patients aged 2 to 26 months, weighing 3 to 16 kg, clearance was reduced compared to older children with the same body weight, receiving similar oral doses per kg body weight as children older than 2 years.
Den gennemsnitlige halveringstid blev vurderet til at være 23 timer hos spædbørn under 26 måneder, som var i enzyminducerende behandling, 136 timer ved administration sammen med valproat og 38 timer hos forsøgspersoner, der blev behandlet uden enzyminduktorer / - hæmmere.
The mean half-life was estimated at 23 hours in infants younger than 26 months on enzyme-inducing therapy, 136 hours when co-administered with valproate and 38 hours in subjects treated without enzyme inducers/ inhibitors.
Den interindividuelle variabilitet i den perorale clearance var høj i gruppen af børn i alderen 2 til 26 måneder (47%).
The inter-individual variability for oral clearance was high in the group of paediatric patients of 2 to 26 months (47%).
De forventede serumkoncentrationer hos børn på 2 til 26 måneder lå generelt inden for samme interval som hos ældre børn, selvom der sandsynligvis vil blive observeret højere Cmax- niveauer hos nogle børn med en legemsvægt på under 10 kg.
The predicted serum concentration levels in children of 2 to 26 months were in general in the same range as those in older children, though higher Cmax levels are likely to be observed in some children with a body weight below 10 kg.
Ældre Resultaterne af en farmakokinetisk populationsanalyse af både unge og ældre patienter med epilepsi, som var inkluderet i de samme forsøg, indikerede, at lamotrigins clearance ikke ændrer sig i et klinisk relevant omfang.
Elderly Results of a population pharmacokinetic analysis including both young and elderly patients with epilepsy, enrolled in the same trials, indicated that the clearance of lamotrigine did not change to a clinically relevant extent.
Efter administration af enkeltdoser faldt den påviselige clearance med 12% fra 35 ml/ min. hos 20- årige til 31 ml/ min. hos 70- årige.
After single doses apparent clearance decreased by 12% from 35 mL/ min at age 20 to 31 mL/ min at 70 years.
Efter 48 ugers behandling var clearance faldet med 10% fra 41 til 37 ml/ min. mellem de unge og ældre grupper.
The decrease after 48 weeks of treatment was 10% from 41 to 37 mL/ min between the young and elderly groups.
Den gennemsnitlige clearance hos de ældre (0, 39 ml/ min. / kg) ligger inden for området af de gennemsnitlige clearanceværdier (0, 31- 0, 65 ml/ min. / kg), der er opnået i ni forsøg hos yngre voksne efter administration af enkeltdoser på 30 til 450 mg.
The mean clearance in the elderly (0.39 mL/ min/ kg) lies within the range of the mean clearance values (0.31 to 0.65 mL/ min/ kg) obtained in nine studies with non-elderly adults after single doses of 30 to 450 mg.
Patienter med nedsat nyrefunktion 12 frivillige forsøgspersoner med kronisk nedsat nyrefunktion og 6 andre forsøgspersoner i hæmodialysebehandling fik hver en enkeltdosis på 100 mg lamotrigin.
Renal impairment Twelve volunteers with chronic renal failure, and another six individuals undergoing hemodialysis were each given a single 100 mg dose of lamotrigine.
Den gennemsnitlige clearance var 0, 42 ml/ min. / kg (kronisk nedsat nyrefunktion), 0, 33 ml/ min. / kg (mellem hæmodialyser) og 1, 57 ml/ min. / kg (under hæmodialyse) i forhold til 0, 58 ml/ min. / kg hos raske frivillige.
Mean clearances were 0.42 mL/ min/ kg (chronic renal failure), 0.33 mL/ min/ kg (between hemodialysis) and 1.57 mL/ min/ kg (during hemodialysis), compared with 0.58 mL/ min/ kg in healthy volunteers.
De gennemsnitlige plasmahalveringstider var 42, 9 timer (kronisk nedsat nyrefunktion), 57, 4 timer (mellem hæmodialyser) og 13, 0 timer (under hæmodialyse) i forhold til 26, 2 timer hos raske frivillige.
Mean plasma half-lives were 42.9 hours (chronic renal failure), 57.4 hours (between hemodialysis) and 13.0 hours (during hemodialysis), compared with 26.2 hours in healthy volunteers.
20% (med et interval på 5, 6 til 35, 1%) af den mængde lamotrigin, der var i kroppen, elimineret i løbet af 4 timers hæmodialyse.
On average, approximately 20% (range = 5.6 to 35.1) of the amount of lamotrigine present in the body was eliminated during a 4-hour hemodialysis session.
4. 2 og 4. 4).
For this patient population, initial doses of lamotrigine should be based on the patient’ s concomitant medicinal products; reduced maintenance doses may be effective for patients with significant renal functional impairment (see sections 4.2 and 4.4).
Patienter med nedsat leverfunktion Der er udført et farmakokinetisk forsøg med enkeltdoser hos 24 forsøgspersoner, som havde forskellige grader af nedsat leverfunktion, og 12 raske forsøgspersoner som kontrolgruppe.
Hepatic impairment A single dose pharmacokinetic study was performed in 24 subjects with various degrees of hepatic impairment and 12 healthy subjects as controls.
Den påviselige medianclearance af lamotrigin var 0, 31, 0, 24 og 0, 10 ml/ min. / kg hos patienter med nedsat leverfunktion i henholdsvis klasse A, B eller C (Child- Pugh- klassificering) i forhold til 0, 34 ml/ min. / kg hos den raske kontrolgruppe.
The median apparent clearance of lamotrigine was 0.31, 0.24 or 0.10 mL/ min/ kg in patients with Grade A, B, or C (Child-Pugh Classification) hepatic impairment, respectively, compared with 0.34 mL/ min/ kg in the healthy controls.
4. 2).
Initial, escalation and maintenance doses should generally be reduced in patients with moderate or severe hepatic impairment (see section 4.2).
Der blev hos unge rotter observeret en påvirkning af indlæringen i Biels labyrinttest, en let forsinkelse af adskillelsen af forhuden fra glans og åbningen af vagina samt en lavere postnatal vægtøgning hos F1- dyr ved eksponeringer, der var ca. to gange højere end de terapeutiske eksponeringer hos voksne mennesker.
70 In juvenile rats, an effect on learning in the Biel maze test, a slight delay in balanopreputial separation and vaginal patency and a decreased postnatal body weight gain in F1 animals were observed at exposures approximately two-times higher than the therapeutic exposures in human adults.
Lamotrigin medførte en dosisrelateret hæmning af hERG- kanalens tilbageløbsstrøm i humane embryoniske nyreceller.
Lamotrigine caused a dose-related inhibition of the hERG channel tail current in human embryonic kidney cells.
IC50- værdierne var ca. ni gange højere end den maksimale terapeutiske frie koncentration.
The IC50 was approximately nine-times above the maximum therapeutic free concentration.
Lamotrigin medførte ikke en QT- forlængelse hos dyr ved eksponeringer på op til ca. to gange den maksimale terapeutiske frie koncentration.
Lamotrigine did not cause QT prolongation in animals at exposures up to approximately two-times the maximum therapeutic free concentration.
5. 1).
In a clinical study, there was no clinically significant effect of lamotrigine on QT interval in healthy adult volunteers (see section 5.1).
Lactosemonohydrat Mikrokrystallinsk cellulose Povidon K30 Natriumstivelsesglycolat (type A) Gul jernoxid (E172) Magnesiumstearat.
Lactose monohydrate Microcrystalline cellulose Povidone K30 Sodium starch glycolate (Type A) Iron oxide yellow (E172) Magnesium stearate.
2, 5, 25, 50, 100 og 200 mg dispergible tabletter / tyggetabletter:
2, 5, 25, 50, 100 and 200 mg dispersible/ chewable tablets:
Calciumcarbonat Lavsubstitueret hydroxypropylcellulose Aluminiummagnesiumsilikat Natriumstivelsesglycolat (type A) Povidon K30 Natriumsaccharin Magnesiumstearat Solbæraroma.
Calcium carbonate Low-substituted hydroxypropyl cellulose Aluminium magnesium silicate Sodium starch glycolate (Type A) Povidone K30 Saccharin sodium Magnesium stearate Blackcurrant flavour.
25, 50, 100 og 200 mg tabletter, 5, 25, 50, 100 og 200 mg dispergible tabletter / tyggetabletter:
25, 50, 100 and 200 mg tablets, 5, 25, 50, 100 and 200 mg dispersible/ chewable tablets:
Tre år.
Three years.
72 2 mg dispergible tabletter / tyggetabletter:
2 mg dispersible/ chewable tablets:
To år.
Two years.
6. 5 Emballagetype og pakningsstørrelser
71 6.5 Nature and contents of container
Blisterpakning af PVC/ aluminiumsfolie.
PVC/ aluminium foil blister.
HDPE- glas med børnesikret/ åbningssikret lukning.
HDPE bottles with a child resistant/ tamper evident closure.
Pakninger med 30 dispergible tabletter / tyggetabletter.
Packs of 30 dispersible/ chewable tablets.
Blisterpakning af PVC/ PVdC/ aluminiumsfolie.
PVC/ PVdC/ aluminium foil blister.
Pakninger med 10, 14, 28, 30, 50 eller 56 dispergible tabletter / tyggetabletter.
Packs of 10, 14, 28, 30, 50 or 56 dispersible/ chewable tablets.
Pakninger med 10, 14, 21, 28, 30, 42, 50, 56 eller 60 dispergible tabletter / tyggetabletter.
Packs of 10, 14, 21, 28, 30, 42, 50, 56 or 60 dispersible/ chewable tablets.
Startpakning med 21 eller 42 dispergible tabletter / tyggetabletter.
Starter pack of 21 or 42 dispersible/ chewable tablets.
Pakninger med 10, 14, 30, 42, 50, 56, 60, 90, 100 eller 200 dispergible tabletter / tyggetabletter.
Packs of 10, 14, 30, 42, 50, 56, 60, 90, 100 or 200 dispersible/ chewable tablets.
Startpakning med 42 dispergible tabletter / tyggetabletter.
Starter pack of 42 dispersible/ chewable tablets.
73 Pakninger med 10, 30, 50, 56, 60, 90, 100 eller 200 dispergible tabletter / tyggetabletter.
Packs of 10, 30, 50, 56, 60, 90, 100 or 200 dispersible/ chewable tablets.
Pakninger med 10, 30, 50, 56, 60, 90, 100 eller 200 dispergible tabletter / tyggetabletter.
Packs of 10, 30, 50, 56, 60, 90, 100 or 200 dispersible/ chewable tablets.
Ikke alle pakningsstørrelser er nødvendigvis markedsført.
72 Not all pack sizes may be marketed.
DD, måned, ÅR
{DD month YYYY}
74 ETIKITTERING
74 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Lamictal og tilknyttede navne (se bilag I) 25 mg tabletter [Se bilag 1 – udfyldes nationalt] Lamotrigin
Lamictal and associated names (see Annex I) 25 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Hver tablet indeholder 25 mg lamotrigin
Each tablet contains 25 mg lamotrigine
Indeholder lactosemonohydrat – se indlægsseddel for yderligere information
Contains lactose monohydrate – see package leaflet for further information
14 tabletter 21 tabletter 30 tabletter 42 tabletter 50 tabletter 56 tabletter 100 tabletter Startpakning 21 tabletter, valproat tillægsbehandling Startpakning 42 tabletter, monoterapi
14 tablets 21 tablets 30 tablets 42 tablets 50 tablets 56 tablets 100 tablets Starter pack 21 tablets, valproate add-on therapy Starter pack 42 tablets, monotherapy
Oral anvendelse Må ikke tygges eller knuses Læs indlægssedlen inden brug
Oral use Do not chew or crush Read the package leaflet before use
Anv. senest {MM/ ÅÅÅÅ}
EXP {MM YYYY}
77 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
76 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Lamictal og tilknyttede navne (se bilag I) 25 mg tabletter [Se bilag I – udfyldes nationalt]
Lamictal and associated names (see Annex I) 25 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Anv. senest MM/ ÅÅÅÅ
EXP {MM YYYY}
(Startpakning 21 tabletter, valproat tillægsbehandling – kalender pakning viser dagnumre):
(Starter pack 21 tablets, valproate add-on therapy – calender pack showing day numbers):
1 3 5 7 9 11 13 (en lomme) 2 4 6 8 10 12 14 (ingen lomme) 15 17 19 21 23 25 27 (en lomme) 16 18 20 22 24 26 28 (en lomme)
1 3 5 7 9 11 13 (one pocket) 2 4 6 8 10 12 14 (no pocket) 15 17 19 21 23 25 27 (one pocket) 16 18 20 22 24 26 28 (one pocket)
(Startpakning 42 tabletter, monoterapi – kalender pakning viser dagnumre):
(Starter pack 42 tablets, monotherapy – calender pack showing day numbers):
1 2 3 4 5 6 7 (en lomme) 8 9 10 11 12 13 14 (en lomme) 15 16 17 18 19 20 21 (to lommer) 22 23 24 25 26 27 28 (to lommer)
1 2 3 4 5 6 7 (one pocket) 8 9 10 11 12 13 14 (one pocket) 15 16 17 18 19 20 21 (two pockets) 22 23 24 25 26 27 28 (two pockets)
78 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
77 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Lamictal og tilknyttede navne (se bilag I) 50 mg tabletter [Se bilag I – udfyldes nationalt] Lamotrigin
Lamictal and associated names (see Annex I) 50 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Hver tablet indeholder 50 mg lamotrigin
Each tablet contains 50 mg lamotrigine
14 tabletter 30 tabletter 42 tabletter 56 tabletter 90 tabletter 100 tabletter Startpakning 42 tabletter, ikke- valproat tillægsbehandling
14 tablets 30 tablets 42 tablets 56 tablets 90 tablets 100 tablets Starter pack 42 tablets, non-valproate add-on therapy
80 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
79 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Lamictal og tilknyttede navne (se bilag I) 50 mg tabletter [Se bilag I – udfyldes nationalt]
Lamictal and associated names (see Annex I) 50 mg tablets [See Annex I - To be completed nationally] Lamotrigine
(Startpakning 42 tabletter, ikke- valproat tillægsbehandling – kalender pakning viser dagnumre):
(Starter pack 42 tablets, non-valproate add-on therapy – calender pack showing day numbers):
1 2 3 4 5 6 7 (1 lomme) 8 9 10 11 12 13 14 (1 lomme) 15 16 17 18 19 20 21 (2 lommer) 22 23 24 25 26 27 28 (2 lommer)
1 2 3 4 5 6 7 (1 pocket) 8 9 10 11 12 13 14 (1 pocket) 15 16 17 18 19 20 21 (2 pockets) 22 23 24 25 26 27 28 (2 pockets)
81 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Lamictal og tilknyttede navne (se bilag I) 100 mg tabletter [Se bilag I – udfyldes nationalt] Lamotrigin
Lamictal and associated names (see Annex I) 100 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Hver tablet indeholder 100 mg lamotrigin
Each tablet contains 100 mg lamotrigine
83 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
82 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
GlaxoSmithKline Pharma A/ S
[See Annex I - To be completed nationally]
Lamictal og tilknyttede navne (se bilag I) 200 mg tabletter [Se bilag I – udfyldes nationalt] Lamotrigin
Lamictal and associated names (see Annex I) 200 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Hver tablet indeholder 200 mg lamotrigin
Each tablet contains 200 mg lamotrigine
30 tabletter 56 tabletter 100 tabletter
30 tablets 56 tablets 100 tablets
85 11.
11.
87 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
86 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
TABLETBEHOLDER
BOTTLE
Lamictal og tilknyttede navne (se bilag I) 2 mg dispergible tabletter / tyggetabletter [Se bilag I – udfyldes nationalt] Lamotrigin
Lamictal and associated names (see Annex I) 2 mg dispersible/ chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Hver dispergibel tablet / tyggetablet indeholder 2 mg lamotrigin
Each dispersible/ chewable tablet contains 2 mg lamotrigine
30 dispergible tabletter / tyggetabletter
30 dispersible/ chewable tablets
88 [Se bilag I – udfyldes nationalt]
[See Annex I - To be completed nationally]
Lamictal og tilknyttede navne (se bilag I) 5 mg dispergible tabletter / tyggetabletter [Se bilag I – udfyldes nationalt] Lamotrigin
Lamictal and associated names (see Annex I) 5 mg dispersible/ chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Hver dispergibel tablet / tyggetablet indeholder 5 mg lamotrigin
Each dispersible/ chewable tablet contains 5 mg lamotrigine
10 dispergible tabletter / tyggetabletter 14 dispergible tabletter / tyggetabletter 28 dispergible tabletter / tyggetabletter 30 dispergible tabletter / tyggetabletter 50 dispergible tabletter / tyggetabletter 56 dispergible tabletter / tyggetabletter
10 dispersible/ chewable tablets 14 dispersible/ chewable tablets 28 dispersible/ chewable tablets 30 dispersible/ chewable tablets 50 dispersible/ chewable tablets 56 dispersible/ chewable tablets
SÆRLIGE OPBEVARINGSBETINGELSER
SPECIAL STORAGE CONDITIONS 89 10.
91 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
90 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Lamictal og tilknyttede navne (se bilag I) 5 mg dispergible tabletter / tyggetabletter [se bilag I – udfyldes nationalt] Lamotrigin
Lamictal and associated names (see Annex I) 5 mg dispersible/ chewable tablets [See Annex I - To be completed nationally] Lamotrigine
92 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
91 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Lamictal og tilknyttede navne (se bilag I) 25 mg dispergible tabletter / tyggetabletter [Se bilag I - udfyldes nationalt] Lamotrigin
Lamictal and associated names (see Annex I) 25 mg dispersible/ chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Hver dispergibel tablet / tyggetablet indeholder 25 mg lamotrigin
Each dispersible/ chewable tablet contains 25 mg lamotrigine
10 dispergible tabletter / tyggetabletter 14 dispergible tabletter / tyggetabletter 21 dispergible tabletter / tyggetabletter 28 dispergible tabletter / tyggetabletter 30 dispergible tabletter / tyggetabletter 42 dispergible tabletter / tyggetabletter 50 dispergible tabletter / tyggetabletter 56 dispergible tabletter / tyggetabletter 60 dispergible tabletter / tyggetabletter Startpakning 21 dispergible tabletter / tyggetabletter, valproat tillægsbehandling Startpakning 42 dispergible tabletter / tyggetabletter, monoterapi
10 dispersible/ chewable tablets 14 dispersible/ chewable tablets 21 dispersible/ chewable tablets 28 dispersible/ chewable tablets 30 dispersible/ chewable tablets 42 dispersible/ chewable tablets 50 dispersible/ chewable tablets 56 dispersible/ chewable tablets 60 dispersible/ chewable tablets Starter pack 21 dispersible/ chewable tablets, valproate add-on therapy Starter pack 42 dispersible/ chewable tablets, monotherapy
94 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
93 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Lamictal og andre tilknyttede navne (se bilag I) 25 mg dispergible tabletter / tyggetabletter [Se bilag I – udfyldes nationalt] Lamotrigin
Lamictal and associated names (see Annex I) 25 mg dispersible/ chewable tablets [See Annex I - To be completed nationally] Lamotrigine
(Starpakning 21 tabletter, valproat tillægsbehandling – kaldender pakning viser dagnumre):
(Starter pack 21 tablets, valproate add-on therapy – calender pack showing day numbers):
1 3 5 7 9 11 13 (en lomme) 2 4 6 8 10 12 14 (ingen lommer) 15 17 19 21 23 25 27 (en lomme) 16 18 20 22 24 26 28 (en lomme)
1 3 5 7 9 11 13 (one pocket) 2 4 6 8 10 12 14 (no pocket) 15 17 19 21 23 25 27 (one pocket) 16 18 20 22 24 26 28 (one pocket)
95 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
94 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Lamictal og tilknyttede navne (se bilag I) 50 mg dispergible tabletter / tyggetabletter [Se bilag I – udfyldes nationalt] Lamotrigin
Lamictal and associated names (see Annex I) 50 mg dispersible/ chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Hver dispergibel tablet / tyggetablet indeholder 50 mg lamotrigin
Each dispersible/ chewable tablet contains 50 mg lamotrigine
10 dispergible tabletter / tyggetabletter 14 dispergible tabletter / tyggetabletter 30 dispergible tabletter / tyggetabletter 42 dispergible tabletter / tyggetabletter 50 dispergible tabletter / tyggetabletter 56 dispergible tabletter / tyggetabletter 60 dispergible tabletter / tyggetabletter 90 dispergible tabletter / tyggetabletter 100 dispergible tabletter / tyggetabletter 200 dispergible tabletter / tyggetabletter Startpakning 42 dispergible tabletter / tyggetabletter, ikke- valproat tillægsbehandling
10 dispersible/ chewable tablets 14 dispersible/ chewable tablets 30 dispersible/ chewable tablets 42 dispersible/ chewable tablets 50 dispersible/ chewable tablets 56 dispersible/ chewable tablets 60 dispersible/ chewable tablets 90 dispersible/ chewable tablets 100 dispersible/ chewable tablets 200 dispersible/ chewable tablets Starter pack 42 dispersible/ chewable tablets, non-valproate add-on therapy
97 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
96 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
(Starter pack 42 tabletter, ikke- valproat tillægsbehandling – kaldender pakning viser dagnumre):
(Starter pack 42 tablets, non-valproate add-on therapy – calender pack showing day numbers):
Lamictal og tilknyttede navne (se bilag I) 100 mg dispergible tabletter / tyggetabletter [Se bilag I – udfyldes nationalt] Lamotrigin
Lamictal and associated names (see Annex I) 100 mg dispersible/ chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Hver dispergibel tablet / tyggetablet indeholder 100 mg lamotrigin
Each dispersible/ chewable tablet contains 100 mg lamotrigine
10 dispergible tabletter / tyggetabletter 30 dispergible tabletter / tyggetabletter 50 dispergible tabletter / tyggetabletter 56 dispergible tabletter / tyggetabletter 60 dispergible tabletter / tyggetabletter 90 dispergible tabletter / tyggetabletter 100 dispergible tabletter / tyggetabletter 200 dispergible tabletter / tyggetabletter
10 dispersible/ chewable tablets 30 dispersible/ chewable tablets 50 dispersible/ chewable tablets 56 dispersible/ chewable tablets 60 dispersible/ chewable tablets 90 dispersible/ chewable tablets 100 dispersible/ chewable tablets 200 dispersible/ chewable tablets
101 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
100 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Lamictal og tilknyttede navne (se bilag I) 200 mg dispergible tabletter / tyggetabletter [Se bilag I – udfyldes nationalt] Lamotrigin
Lamictal and associated names (see Annex I) 200 mg dispersible/ chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Hver dispergibel tablet / tyggetablet indeholder 200 mg lamotrigin
Each dispersible/ chewable tablet contains 200 mg lamotrigine
10 dispergible tabletter / tyggetabletter 30 dispergible tabletter / tyggetabletter 42 dispergible tabletter / tyggetabletter 50 dispergible tabletter / tyggetabletter 56 dispergible tabletter / tyggetabletter 60 dispergible tabletter / tyggetabletter 90 dispergible tabletter / tyggetabletter 100 dispergible tabletter / tyggetabletter 200 dispergible tabletter / tyggetabletter
10 dispersible/ chewable tablets 30 dispersible/ chewable tablets 50 dispersible/ chewable tablets 56 dispersible/ chewable tablets 60 dispersible/ chewable tablets 90 dispersible/ chewable tablets 100 dispersible/ chewable tablets 200 dispersible/ chewable tablets
103 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
102 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
104 INDLÆGSSEDDEL
104 PACKAGE LEAFLET: