natgillin/translations-raw huggingface dataset:
Der blev udført en samlet evaluering frem til 30. september 2007 af alle hepatiske bivirkninger (alvorlige og ikke- alvorlige) og en samlet vurdering af benefit/ risk- forholdet for moxifloxacin- behandling.
A cumulative review up to 30 September 2007 of all hepatic reactions (serious and non-serious) and an overall assessment of the benefit/ risk ratio of moxifloxacin treatment was performed.
Ud af et samlet antal på 48 identificerede tilfælde af mulige moxifloxacin- relaterede leverlidelser med dødelig udgang uanset årsag, blev 8 tilfælde mistænkt for at være moxifloxacin- induceret fatal hepatotoksicitet.
Of a total of 48 identified cases of possibly moxifloxacin-related liver disorders with a fatal outcome of any cause, 8 were suspected cases of moxifloxacin-induced fatal hepatotoxicity.
På baggrund af ovenstående udsendte Det Forenede Kongerige en varslingsmeddelelse, som i henhold til artikel 107 i direktiv 2001/ 83/ EF, med senere ændringer, informerede medlemsstaterne, Det Europæiske Lægemiddelagentur (EMEA) og Kommissionen om dets beslutning om at ændre markedsføringstilladelserne for alle orale formuleringer af moxifloxacin- holdige lægemidler for at fjerne indikationen til behandling af ABS og AECB og begrænse indikationen til behandling af CAP.
Based on the above, on 2 June 2008, the UK issued a Rapid Alert informing Members States, the European Medicines Agency (EMEA) and the European Commission (EC) in accordance with Article 107 of Directive 2001/ 83/ EC, as amended of its intention to vary the marketing authorisation of all oral formulations of moxifloxacin containing medicinal products to remove the indications in ABS and AECB and to restrict the indication in CAP.
CHMP gennemgik alle de oplysninger, som indehaverne af markedsføringstilladelserne havde indsendt om benefit/ risk- forholdet for oral moxifloxacin til de ovenstående indikationer.
The CHMP reviewed all of the information made available by marketing authorisation holders (MAH) on the balance of benefits and risks of oral moxifloxacin in the above indications.
ABS ABS er generelt en ikke- alvorlig infektion, der forbindes med en høj grad af spontan helbredelse (90%).
ABS ABS is generally a non-severe infection associated with high spontaneous cure rates (90%).
Selv om moxifloxacin har vist sig at have en effekt, er mængden af tilgængelige data begrænset, da der hovedsagligt er udført undersøgelser imod komparatorer, og det lykkedes ikke ved den eneste placebo- kontrollerede undersøgelse at påvise statistisk overlegenhed i forhold til placebo.
Although moxifloxacin has shown to be effective, the available data is limited as studies have been mainly performed against comparators and the only placebo controlled study failed to demonstrate statistical superiority over placebo.
Benefit/ risk- forholdet for moxifloxacin kan dog være positivt, hvis anden antibiotikabehandling ikke har vist resultat eller ikke kan anvendes.
However, the benefit risk of moxifloxacin may be favourable if other antibiotherapy has failed or cannot be used.
AECB Fordelen ved antibiotisk behandling af AECB blev understøttet af adskillige publikationer, herunder en metaanalyse, og af en nylig systematisk gennemgang fra Cochrane Centre, som antyder nedsat
AECB The benefit of antibiotic treatment of AECB was supported by several publications including a meta- analysis and by a recent systematic review from Cochrane Centre suggesting a mortality benefit with the use of antibiotics in this indication in comparison with placebo and a beneficial effect on lung function.
2 dødelighed ved brug af antibiotika til denne indikation sammenlignet med placebo og en gavnlig virkning for lungefunktionen.
2 show equivalence between medicinal products did not demonstrate clinical superiority of any class of antibiotics over another.
Ydermere benyttede de fleste af de fase III- undersøgelser, som var designet til at påvise, at moxifloxacin ikke vare ringere, ikke det anbefalede foretrukne stof.
Additionally, most of the phase III studies designed for non-inferiority for moxifloxacin did not use the recommended agent of choice.
I overensstemmelse med sikkerhedsprofilen og i betragtning af, at AECB kan være en mindre alvorlig infektion med en høj grad af spontan helbredelse, og for hvilken der kun i 50% af tilfældene kan findes bakterier, kan benefit/ risk- forholdet kun være positivt, hvis moxifloxacin ikke er den behandlingsmulighed, der vælges først.
In line with the safety profile, and considering that AECB can be a less severe infection, with high spontaneous resolution rate for which bacteria can be found in only 50% of all exacerbations, the benefit risk can only be considered favourable if moxifloxacin is not used as the first line treatment option.
CAP De kliniske undersøgelser og publicerede data tyder på, at moxifloxacin generelt har fordele ved indikationen CAP.
CAP Clinical trial and published data indicate that moxifloxacin generally has benefits in the indication CAP.
Hvis andre antibiotiske behandlinger og resistens tages i betragtning, er der i nogle tilfælde desuden observeret fordele i forhold til andre behandlinger i behandlingen af CAP- tilfælde af lav til moderat sværhed.
Furthermore, when taking into account other antiobiotherapy available and resistance, some times advantages over other therapies are observed in the treatment of CAP of mild to moderate severity.
På baggrund af ovenstående oplysninger anbefalede CHMP begrænsning af andetvalgsbehandling ved indikationer for moxifloxacin- holdige lægemidler (oral formulering) og yderligere ændringer i produktoplysningerne, sådan at den også omfatter tilfælde af hepatotoksicitet, risikofaktorer for forlænget QTc- interval, og styrkelse af advarslerne mod Clostridium difficille- associeret kolitis og bulløse hudreaktioner.
In view of the above, the CHMP recommended the restriction to 2nd line treatment in the indications for moxifloxacin containing medicinal products (oral formulation) and further amendments to the PI, to include fatal hepatotoxicity cases, risk factors for QTc interval prolongation, and strengthen the warnings on Clostridium difficille-associated colitis and bullous skin reactions.
BEGRUNDELSER INDLÆGSSEDLERNE
GROUNDS
FOR
FOR
AF
OF
PRODUKTRESUMÉERNE
OF THE SUMMARIES OF
OG
PRODUCT
Ud fra følgende
CHARACTERISTICS AND PACKAGE LEAFLETS
betragtninger:
Whereas,
Udvalget fulgte proceduren i artikel 107 i direktiv 2001/ 83/ EF, med senere ændringer, for lægemidler, der indeholder moxifloxacin i orale formuleringer.
The Committee considered the procedure under Article 107 of Directive 2001/ 83/ EC, as amended, for medicinal products containing moxifloxacin in oral formulations.
På basis af de tilgængelige oplysninger konkluderede udvalget, at det foreliggende benefit/ risk - forhold for moxifloxacin- holdige lægemidler i orale formuleringer til de pågældende godkendte indikationer er tilfredsstillende som andetvalgsindikationer.
In view of the available data the Committee concluded that the benefit risk balance of moxifloxacin containing medicinal products in oral formulations in the approved indications under review is favourable as second line indications.
På baggrund af de tilgængelige sikkerhedsdata konkluderede udvalget, at tilfælde af fatal hepatotoksicitet, risikofaktorer for forlænget QTc- interval skal afspejles i produktoplysningerne, og at advarslerne om Clostridium difficille- associeret kolitis og bulløse hudreaktioner skal styrkes.
In view of the safety available data the Committee concluded that cases of fatal hepatotoxicity, risk factors for QTc interval prolongation should be reflected in the product information, and that the warnings on Clostridium difficille-associated colitis and bullous skin reactions should be strengthen.
Floridsdorfer Hauptstraße 1 1210 Wien, Østrig
Pfizer Corporation Austria Gesellschaft m. b. H Floridsdorfer Hauptstraße 1 1210 Wien, Austria
Filmovertrukne tabletter Oral anvendelse
Film-coated tablets
Østrig
Oral use
Floridsdorfer Hauptstraße 1 1210 Wien, Østrig
Floridsdorfer Haupstraße 1 1210 Wien, Austria
Boulevard de la Plaine, 17 B- 1050 Bruxelles Belgien
Boulevard de la Plaine, 17 B-1050 Bruxelles Belgium
Belgien
2
Belgien
Oral use
Tjekkiet
Oral use
PFIZER SPOL S R. O., Stroupežnického 17, 15000 Praha 5
PFIZER SPOL S R. O., Stroupež nického17, 15000 Praha 5
243, Messoghion Ave., Neo Psychiko 154 51 Grækenland
243, Messoghion Ave., Neo Psychiko 154 51 Greece
Hårde kapsler Oral anvendelse
Capsules, hard
Cypern
Oral use
3 Danmark
Denmark
Lautrupvang 8 2750 Ballerup
Lautrupvang 8 2750 Ballerup
Danmark
Oral use
Pfizer Europe MA EEIG Ramsgate Road, Sandwich Kent, CT 13 9NJ Storbritannien
Pfizer Europe MA EEIG Ramsgate Road, Sandwich Kent, CT 13 9NJ UK
Pfizer Europe MA EEIG Ramsgate Road, Sandwich Kent, CT 13 9NJ Storbritannien
Pfizer Europe MA EEIG
Estonien
4
Pfizer Europe MA EEIG Ramsgate Road, Sandwich
Pfizer Europe MA EEIG Ramsgate Road, Sandwich Kent, CT 13 9NJ UK
Estonien
Oral use
Pfizer Oy, Tietokuja 4 00330 Helsinki Finland
Pfizer Oy, Tietokuja 4 00330 Helsinki Finland
Finland
Oral use
Frankrig
5 France
Pfizer 23- 25 avenue du Docteur Lannelongue F- 75668 Paris Cedex 14
Pfizer 3-25 avenue du Docteur Lannelongue F-75668 Paris Cedex 14
Frankrig
Pfizer 3-25 avenue du Docteur Lannelongue F-75668 Paris Cedex 14
Parke- Davis GmbH Pfizerstrasse 1 76139 Karlsruhe
Parke-Davis GmbH Pfizerstrasse 1 76139 Karlsruhe
Tyskland
Oral use
Tyskland
6
PFIZER HELLAS
PFIZER HELLAS 243 Messoghion Ave., Neo Psychiko 154 51 Greece
Pfizer Aps Lautrupvang 8 2750 Ballerup Danmark
Pfizer Aps Lautrupvang 8
Pfizer Aps Lautrupvang 8 2750 Ballerup Danmark
2750 Ballerup Denmark
Island
Oral use
7 Irland
Ireland
Pfizer Healthcare Irland 9 Riverwalk, National Digital Pk, Citywest Business Campus, Dublin 24, Irland c/ o Pfizer Ltd.
Pfizer Healthcare Ireland 9 Riverwalk, National Digital Pk, Citywest Business Campus, Dublin 24, Ireland c/ o Pfizer Ltd.
Walton Oaks Dorking Road Tadworth, Surrey KT20 7NS
Walton Oaks Dorking Road Tadworth, Surrey KT20 7NS
Irland
Pfizer Healthcare Ireland
Irland
8
Pfizer Healthcare Irland 9 Riverwalk, National Digital Pk, Citywest Business Campus, Dublin 24, Irland c/ o Pfizer Ltd.
Walton Oaks Dorking Road Tadworth, Surrey KT20 7NS
Pfizer Healthcare Irland 9 Riverwalk, National Digital Pk, Citywest Business Campus,
Pfizer Healthcare Ireland 9 Riverwalk, National Digital Pk, Citywest Business Campus, Dublin 24, Ireland c/ o Pfizer Ltd.
Irland
Oral use
Walton Oaks Dorking Road Tadworth, Surrey KT20 7NS
Walton Oaks Dorking Road
Ungarn
Pfizer Kft.
MOM Park “ F ” épület
MOM Park “ F” épület
9 Ungarn
Oral use
Letland
Pfizer Limited.
Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ, Storbritannien
Ramsgate Road Sandwich, Kent CT13 9NJ, UK
Pfizer Limited
Ramsgate Road Sandwich, Kent CT13 9NJ, UK
10 Ramsgate Road Sandwich, Kent CT13 9NJ, Storbritannien
Lithuania
Lithauen
Pfizer Limited.
Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ, Storbritannien
Ramsgate Road Sandwich, Kent
Boulevard de la Plaine 17 B- 1050 Bruxelles Belgien
Boulevard de la Plaine 17 B-1050 Bruxelles Belgium
Boulevard de la Plaine 17 B- 1050 Bruxelles Belgien
Boulevard de la Plaine 17 B-1050
Luxembourg
Oral use
Pfizer Hellas A. E., Alketou 5, 11633 Athen Grækenland
Pfizer Hellas A. E., Alketou 5, 11633 Athens Greece
Pfizer AS Postboks 3
Pfizer AS Postboks 3 NO-1324 Lysaker
Norge
Oral use
Pfizer AS Postboks 3 NO- 1324 Lysaker
Pfizer AS Postboks 3 NO-1324 Lysaker
Norge
13
Parke- Davis GmbH Pfizerstr 1, 76139 Karlsruhe, Tyskland
Parke-Davis GmbH Pfizerstr 1, 76139 Karlsruhe, Germany
Rzymowskiego 28 02- 697 Warszawa
Rzymowskiego 28 02-697 Warszawa
13 Portugal
Portugal
Lagoas Park - Edifício nº 10 2740- 271 Porto Salvo
Lagoas Park - Edifício nº 10 102740-271Porto Salvo
Portugal
14
Holland
Oral use
Pfizer BV Rivium Westlaan 142 2909 LD Capelle a/ d IJssel
Pfizer BV Rivium Westlaan 142 2909 LD Capelle a/ d IJssel
Pfizer BV
Pfizer BV Rivium Westlaan 142 2909 LD Capelle a/ d IJssel
14 Rivium Westlaan 142 2909 LD Capelle a/ d IJssel
Oral use
Pfizer Luxembourg SARL 283, route d’ Arlon L- 8011 Strassen Luxembourg
Pfizer Luxembourg SARL 283, route d’ Arlon L-8011 Strassen Luxembourg
Pfizer Luxembourg SARL 283, route d’ Arlon L- 8011 Strassen Luxembourg
Pfizer Luxembourg SARL
Slovenien
15 283, route d’ Arlon L-8011 Strassen Luxembourg
Pfizer Limited Ramsgate Road, Sandwich Kent, CT13 9NJ, Storbritannien
Pfizer Limited Ramsgate Road, Sandwich Kent, CT13 9NJ, UK
Pfizer Luxembourg SARL, branch office Dubravska cesta 2, 841 04 Bratislava, Slovakiet
Pfizer Luxembourg SARL, branch office Dubravska cesta 2, 841 04 Bratislava, Slovak Republic
Slovakiet
16
16 Kontaktadresse:
Contact address:
Parque Empresarial La Moraleja 28108 Alcobendas
Parque Empresarial La Moraleja
Spanien
28108 Alcobendas
Parque Empresarial La Moraleja 28108 Alcobendas
Parque Empresarial La Moraleja 28108 Alcobendas
Sverige
Oral use
Pfizer AB 191 90 Sollentuna
Pfizer AB 91 90 Sollentuna
Pfizer AB
Pfizer AB 91 90 Sollentuna
Ramsgate Road Sandwich Kent, CT13 9NJ, UK C/ o Walton Oaks Dorking Road Tadworth, Surrey KT20 7NS
Ramsgate Road Sandwich Kent, CT13 9NJ, UK C/ o Walton Oaks
Storbritannien
Dorking Road
Ramsgate Road Sandwich Kent, CT13 9NJ, UK C/ o Walton Oaks Dorking Road Tadworth, Surrey KT20 7NS
Ramsgate Road Sandwich Kent, CT13 9NJ, UK C/ o Walton Oaks Dorking Road Tadworth, Surrey KT20 7NS
Ramsgate Road Sandwich Kent, CT13 9NJ, UK C/ o Walton Oaks Dorking Road
Ramsgate Road Sandwich Kent, CT13 9NJ, UK C/ o Walton Oaks Dorking Road Tadworth, Surrey KT20 7NS
Storbritannien
Oral use
22 FAGLIGE KONKLUSIONER
20 SCIENTIFIC CONCLUSIONS
• Ikke- kliniske spørgsmål
• Non-clinical issues
Hvad angår indikationen smerter, underbygges anvendelsen af Neurontin til behandling af post - herpetisk neuralgi og smertefuld diabetisk perifer neuropati dels af en gennemgang af de allerede forliggende oplysninger, dels af resultaterne af den nylig gennemførte placebokontrollerede kliniske multicenterundersøgelse.
Regarding the indication in pain, the review of the previously available information and the review of the results of the newly conducted multicenter, placebo-controlled clinical study supports the use of Neurontin for the treatment of post-herpetic neuralgia and painful diabetic peripheral neuropathy.
"Gabapentin er indiceret til behandling af perifere neuropatiske smerter såsom smertefuld diabetisk neuropati og post- herpetisk neuralgi hos voksne."
Therefore, the MAH proposal of a harmonised wording was endorsed; as follows: “ Gabapentin is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults .”
I en klinisk undersøgelse vedrørende supplerende behandling af partiel epilepsi hos børn i alderen 3 til 12 år var der en numerisk højere andel af patienter med 50% respons i gabapentingruppen end i placebogruppen, men forskellen var ikke signifikant.
A clinical trial of adjunctive treatment of partial seizures in paediatric subjects, ranging in age from 3 to 12 years, showed a numerical but not statistically significant difference in the 50% responder rate in favour of the gabapentin group compared to placebo.
Yderligere post hoc- analyser af responsraten, fordelt på alder, afslørede ingen statistisk signifikant indflydelse af alderen, hverken som kontinuert eller dikotom variabel (aldersgrupperne 3- 5 og 6- 12 år).
Additional post-hoc analyses of the responder rates by age did not reveal a statistically significant effect of age, either as a continuous or dichotomous variable (age groups 3-5 and 6-12 years).
Afsnit 5. 1 er ført ajour vedrørende virkningen hos børn.
In spite of these modest results, taking into consideration the adequate safety profile and the medical need in this paediatric population, the CHMP agreed to the following indication: “ Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1) .” An update of efficacy data in children has been made in section 5.1.
Doseringen skal justeres individuelt, afhængigt af respons og tolerabilitet.
21 Therefore, the following indication was agreed by the CHMP: “ Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above .” The posology is to be adjusted individually depending on response and tolerability.
Fraværet af langtidsundersøgelser (over 36 uger) til vurdering af vækst, indlæring, intelligens og udvikling hos børn og unge er nævnt i afsnit 4. 4.
The absence of adequate long term studies (more than 36 weeks) in children to assess growth, learning, intelligence, and development in children and adolescents, is mentioned in section 4.4.
Risk/ benefit- hensyn
Benefit/ Risk considerations
På grundlag af den dokumentation, der er forelagt af indehaveren af markedsføringstilladelsen, og de faglige drøftelser i udvalget anser CHMP benefit/ risk- forholdet for neurontin og tilknyttede navne for positivt ved anvendelse til:
Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CHMP considered that the benefit/ risk ratio of neurontin and associated names is favourable relating to:
Gabapentin er indiceret til supplerende behandling af partiel epilepsi, med eller uden sekundære, generaliserede anfald, hos voksne og børn over 6 år (se afsnit 5. 1).
Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1).
Gabapentin er indiceret som monoterapi ved partiel epilepsi, med eller uden sekundære, generaliserede anfald, hos voksne og unge over 12 år.
Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above.
Gabapentin er indiceret til behandling af perifere neuropatiske smerter såsom smertefuld diabetisk neuropati og post- herpetisk neuralgi, hos voksne.
Gabapentin is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults.
- hensigten med indbringelsen af sagen var at harmonisere produktresuméet,
the scope of the referral was the harmonisation of the Summary of Product Characteristics, labelling and package leaflet
etiketteringen og indlægssedlen
-
- det produktresumé og den etikettering og indlægsseddel, der er foreslået af
the Summary of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
indehaveren af markedsføringstilladelsen, er blevet vurderet på grundlag af den forelagte dokumentation og de faglige drøftelse i udvalget,
22 the CHMP has recommended amendments of the Summary of Products Characteristic, Labelling and Package Leaflet, as set out in Annexe III of the CHMP opinion for Neurontin and associated names (see Annexe I of the opinion).
anbefaler CHMP ændring af produktresumé, etikettering og indlægsseddel, som det fremgår af bilag III til CHMPs udtalelse for Neurontin og tilknyttede navne (se bilag I til udtalelsen).
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
24 25 BILAG III
24 SUMMARY OF PRODUCT CHARACTERISTICS
Neurontin og ledsagende navne 100 mg hårde kapsler Neurontin og ledsagende navne 300 mg hårde kapsler Neurontin og ledsagende navne 400 mg hårde kapsler Neurontin og ledsagende navne 600 mg filmovertrukne tabletter Neurontin og ledsagende navne 800 mg filmovertrukne tabletter
Neurontin and associated names 100 mg hard capsule Neurontin and associated names 300 mg hard capsule Neurontin and associated names 400 mg hard capsule Neurontin and associated names 600 mg film-coated tablet Neurontin and associated names 800 mg film-coated tablet
1 hård kapsel på 100 mg indeholder 100 mg gabapentin.
Each 100 mg hard capsule contains 100 mg of gabapentin.
Hårde kapsler.
Capsule, hard
5. 1).
Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1).
28 Gabapentin er som monoterapi indiceret til behandling af partiel epilepsi, med eller uden sekundære, generaliserede anfald hos voksne og unge på 12 år og derover.
26 Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above.
Behandling af perifere neurogene smerter
Treatment of peripheral neuropathic pain
Gabapentin er indiceret til behandling af perifere neurogene smerter, som f. eks. smertefuld diabetisk neuropati og postherpetisk neuropati hos voksne.
Gabapentin is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults.
1 glas vand).
Gabapentin can be given with or without food and should be swallowed whole with sufficient fluid- intake (e. g. a glass of water).
Initiering af behandling for alle indikationer er anført i nedenstående behandlingsplan (tabel 1).
For all indications a titration scheme for the initiation of therapy is described in Table 1, which is recommended for adults and adolescents aged 12 years and above.
2.
Dosing instructions for children under 12 years of age are provided under a separate sub-heading later in this section.
Tabel 1 DOSERINGSPLAN – INITIALTITRERING Dag 1 300 mg 1 gang dagligt
Table 1 DOSING CHART – INITIAL TITRATION Day 1 300 mg once a day
Dag 2 300 mg 2 gange dagligt
Day 2 300 mg two times a day
Dag 3 300 mg 3 gange dagligt
Day 3 300 mg three times a day
Epilepsi kræver sædvanligvis langtidsbehandling.
Epilepsy Epilepsy typically requires long-term therapy.
Det bør ske gradvist over mindst 1 uge.
When in the judgment of the clinician there is a need for dose reduction, discontinuation, or substitution with an alternative medication, this should be done gradually over a minimum of one week.
I kliniske undersøgelser er det effektive dosisinterval 900- 3600 mg/ dag.
In clinical trials, the effective dosing range was 900 to 3600 mg/ day.
På baggrund af patientens respons og tolerans, kan dosis derefter øges med en dosistilvækst på 300 mg dagligt hver 2. - 3. dag op til maksimalt 3600 mg dagligt.
Thereafter, based on individual patient response and tolerability, the dose can be further increased in 300 mg/ day increments every 2-3 days up to a maximum dose of 3600 mg/ day.
Det tager mindst 1 uge at nå en dosis på 1800 mg dagligt, 2 uger at nå en dosis på 2400 mg dagligt, og i alt 3 uger at nå en dosis på 3600 mg dagligt.
The minimum time to reach a dose of 1800 mg/ day is one week, to reach 2400 mg/ day is a total of 2 weeks, and to reach 3600 mg/ day is a total of 3 weeks.
Doser på op til 4800 mg dagligt var veltålt i åbne langtidsundersøgelser.
Dosages up to 4800 mg/ day have been well tolerated in long-term open-label clinical studies.
3 dage.
The starting dose should range from 10 to 15 mg/ kg/ day and the effective dose is reached by upward titration over a period of approximately three days.
Den effektive dosis af gabapentin hos børn på 6 år og derover er 25- 35 mg/ kg dagligt.
The effective dose of gabapentin in children aged 6 years and older is 25 to 35 mg/ kg/ day.
Doser på op til 50 mg/ kg dagligt var veltålt i en åben langtidsundersøgelse.
Dosages up to 50 mg/ kg/ day have been well tolerated in a long- term clinical study.
Perifere neurogene smerter
27 Peripheral neuropathic pain
29 Voksne
Adults
Alternativt anbefales en initialdosis på 900 mg dagligt fordelt på 3 lige store doser.
Alternatively, the starting dose is 900 mg/ day given as three equally divided doses.
Behandling af perifere neurogene smerter, som f. eks. smertefuld diabetisk neuropati og postherpetisk neuropati, er ikke undersøgt i behandlingsperioder længere end 5 måneder i kliniske undersøgelser.
In the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia, efficacy and safety have not been examined in clinical studies for treatment periods longer than 5 months.