natgillin/translations-raw huggingface dataset:
De er anført efter organklasse og hyppighed (meget almindelig (> 1/ 10), almindelig (> 1/ 100, < 1/ 10), ikke almindelig (> 1/ 1. 000, < 1/ 100) og sjælden (< 1/ 1. 000)).
In the table below all adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency (very common (> 1/10), common (> 1/100, < 1/10), uncommon (> 1/1000, < 1/100) and rare (< 1/1000)).
De anførte bivirkninger kan også have forbindelse til den tilgrundliggende sygdom og/ eller anden samtidig behandling.
The adverse reactions listed may also be associated with the underlying disease and / or concomitant medications.
4. 4).
In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse events in general, CNS adverse events and especially somnolence was increased (See 4.4).
Yderligere bivirkninger, der er rapporteret efter markedsføring, er anført i kursiv som ” hyppighed ikke kendt ” i tabellen nedenfor.
Additional reactions reported from post-marketing experience are included as Unknown frequency in italics in the list below.
Organklasse Immunsystemet
Body System Immune system disorders
Hyppighed ikke kendt Blod - og lymfesystem
Unknown frequency Blood and lymphatic system Rare
Overfølsomhed, angioødem, allergiske reaktioner.
Hypersensitivity, angioedema, allergic reaction disorders Neutropenia
Sjælden Metabolisme og ernæring
Metabolism and nutrition disorders Common Uncommon Rare Psychiatric disorders
Almindelig Ikke almindelig Sjælden Psykiske forstyrrelser
Appetite increased Anorexia Hypoglycaemia
Hypoglykæmi.
Common Uncommon
Halluciationer, panikanfald, rastløshed, agitation, depression, forsænket stemningsleje, humørsvingninger, depersonalisation, forværret søvnløshed, svært ved at finde ord, drømmeforstyrrelser, øget libido, anorgasme, apati.
Euphoric mood, confusion, irritability, libido decreased Hallucination, panic attack, restlessness, agitation, depression, depressed mood, mood swings, depersonalisation, insomnia exacerbated, word finding difficulty, abnormal dreams, libido increased, anorgasmia, apathy
Sjælden Nervesystemet
Rare Nervous system disorders
Impulsivitet, hævet stemningsleje.
Disinhibition, elevated mood
Ataksi, koordinationsforstyrrelser, tremor, dysartri, hukommelsesproblemer, opmærksomhedsforstyrrelser, paræstesi.
Dizziness, somnolence Ataxia, coordination abnormal, tremor, dysarthria, memory impairment, disturbance in attention, paraesthesia
6 Ikke almindelig
Uncommon
Synkope, stupor, myokloni, psykomotorisk hyperaktivitet, manglende smagsopfattelse, dyskinesi, ortostatisk svimmelhed, intentionstremor, nystagmus, kognitiv forstyrrelse, taleproblemer, hyporefleksi, hypæstesi, amnesi, hyperæstesi, brændende fornemmelse.
Syncope, stupor, myoclonus, psychomotor hyperactivity, ageusia, dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive disorder, speech disorder, hyporeflexia, hypoaesthesia, amnesia, hyperaesthesia, burning sensation
Sjælden Hyppighed ikke kendt Øjne
Rare Unknown frequency
Bevidsthedstab, mental svækkelse, hovedpine.
Hypokinesia, parosmia, dysgraphia Loss of consciousness, mental impairment, headache
Almindelig Ikke almindelig
Eye disorders
Sløret syn, dobbeltsyn.
Common Uncommon
Synsforstyrrelser, hævede øjne, synsfeltdefekt, nedsat synsskarphed, øjensmerter, øjentræthed, tørre øjne, øget tåreflåd.
Vision blurred, diplopia Visual disturbance, eye swelling, visual field defect, visual acuity reduced, eye pain, asthenopia, dry eye, lacrimation increased
Tab af perifert syn, oscillopsi, ændret opfattelse af dybdesyn, fotopsi, øjenirritation, mydriasis, skelen, øget lysindtryk.
Peripheral vision loss, oscillopsia, altered visual depth perception, photopsia, eye irritation, mydriasis, strabismus, visual brightness
Hyppighed ikke kendt Øre og labyrint
Unknown frequency Ear and labyrinth disorders
Almindelig Sjælden Hjerte
Common Rare Cardiac disorders
Støjoverfølsomhed.
Vertigo Hyperacusis
Atrioventrikulært blok af første grad, sinustakykardi, sinusbradykardi, sinusarytmi.
Tachycardia Atrioventricular block first degree, sinus tachycardia, sinus bradycardia, sinus arrhythmia
Hyppighed ikke kendt Vaskulære sygdomme
Unknown frequency Vascular disorders
Kronisk venstresidig hjerteinsufficiens.
Congestive heart failure
Hypotension, hypertension, perifer kuldefølelse.
Flushing, hot flushes Hypotension, hypertension, peripheral coldness
Luftveje, thorax og mediastinum Ikke almindelig Sjælden Mave- tarmkanalen
Respiratory, thoracic and mediastinal disorders Uncommon Rare Gastrointestinal disorders
Næseblod, følelse af at halsen snører sig sammen, nasal pharyngitis, hoste, nasal kongestion, rhinitis, snorken.
Dyspnoea, nasal dryness Epistaxis, throat tightness, nasopharyngitis, cough, nasal congestion, rhinitis, snoring
Oppustedhed, gastrooesofageal refluks, øget spytsekretion, oral hypæstesi.
Vomiting, dry mouth, constipation, flatulence Abdominal distension, gastrooesophageal reflux disease, salivary hypersecretion, hypoaesthesia oral
Sjælden Hyppighed ikke kendt Hud og subkutane væv
Rare Unknown frequency
Opsvulmet tunge, diarré, kvalme.
Ascites, pancreatitis, dysphagia Swollen tongue, diarrhoea, nausea
Ikke almindelig Sjælden Hyppighed ikke kendt
Skin and subcutaneous tissue disorders Uncommon Rare Unknown frequency
Stevens- Johnsons Syndrom, kløe
Rash papular, sweating Urticaria, cold sweat Stevens Johnson syndrome,Pruritus
Muskeltrækninger, ledhævelser, muskelkramper, myalgi, artralgi, rygsmerter, ekstremitetssmerter, muskelstivhed.
Muscle twitching, joint swelling, muscle cramp, myalgia, arthralgia, back pain, pain in limb, muscle stiffness
Sjælden Nyrer og urinveje
Rare Renal and urinary disorders
Rhabdomyolyse, spasmer i cervikalmuskulaturen, nakkesmerter.
Rhabdomyolysis, cervical spasm, neck pain
Ikke almindelig Sjælden Hyppighed ikke kendt
Uncommon Rare Unknown frequency
Urinretention
Urinary incontinence, dysuria Renal failure, oliguria Urinary retention
Det reproduktive system og mammae Almindelig Ikke almindelig Sjælden
Reproductive system and breast disorders Common Uncommon Rare
Forsinket ejakulation, seksual dysfunktion Amenorré, brystflåd, brystsmerter, dysmenoré, mammahypertrofi.
Erectile dysfunction Ejaculation delayed, sexual dysfunction Amenorrhoea, breast discharge, breast pain, dysmenorrhoea, hypertrophy breast
7 Almene symptomer og reaktioner på administrationsstedet Almindelig
General disorders and administration site conditions Common Uncommon Rare Unknown frequency Investigations
Gangforstyrrelser, følelse af beruselse, træthed, perifere ødemer, ødem.
Gait abnormal, feeling drunk, fatigue, oedema peripheral, oedema, Fall, chest tightness, asthenia, thirst Anasarca, pyrexia, rigors, pain exacerbated, Face oedema
Ansigtsødem.
Common Uncommon
Forhøjet blod- kreatinin- fosfokinase, forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, nedsat antal blodplader.
Weight increased Blood creatine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, platelet count decreased
Forhøjet blodsukkerniveau, fald i se- kalium, nedsat antal hvide blodlegemer, se- kreatinin stigning, vægttab.
Blood glucose increased, blood potassium decreased, white blood cell count decreased, blood creatinine increased, weight decreased
Der er ingen data tilgængelig vedrørende hyppighed og sværhedsgrad af seponeringssymptomer i relation til varighed og dosering af pregabalin i forbindelse med seponering af langtidsbehandling med pregabalin.
Concerning discontinuation of long-term treatment of pregabalin there are no data of the incidence and severity of withdrawal symptoms in relation to duration of use and dosage of pregabalin.
Søvnighed, konfus tilstand, agitation og rastløshed har efter markedsføring vist sig at være blandt de hyppigst rapporterede bivirkninger, når pregabalin tages i overdosis.
In overdoses up to 15 g, no unexpected adverse reactions were reported.
Ved overdosis op til 15 g er der ikke rapporteret uventede bivirkninger.
In the post-marketing experience, the most commonly reported adverse events observed when pregabalin was taken in overdose included somnolence, confusional state, agitation, and restlessness.
4. 2, tabel 1).
Treatment of pregabalin overdose should include general supportive measures and may include haemodialysis if necessary (see section 4.2 Table 1).
Antiepileptika, ATC- kode:
Antiepileptics, ATC code:
Det aktive indholdsstof, pregabalin, er en gamma- aminosmørsyre analog ((S) - 3 - (aminomethyl) - 5 - methylhexansyre).
The active substance, pregabalin, is a gamma-aminobutyric acid analogue ((S)-3-(aminomethyl)-5- methylhexanoic acid).
Pregabalin bindes til en hjælpeundergruppe (α2- δ protein) i de spændingsafhængige kalciumkanaler i centralnervesystemet, ved potent at fortrænge [3H] - gabapentin.
Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system, potently displacing [3H]-gabapentin.
Studier har vist effekt overfor diabetisk neuropati, post- herpetisk neuralgi og rygmarvskader.
Efficacy has been shown in studies in diabetic neuropathy, post herpetic neuralgia and spinal cord injury.
8 Pregabalin er undersøgt i 10 kontrollerede kliniske studier i op til 13 uger med dosering 2 gange dagligt, og i op til 8 uger med dosering 3 gange dagligt.
Pregabalin has been studied in 10 controlled clinical studies of up to 13 weeks with twice a day dosing (BID) and up to 8 weeks with three times a day (TID) dosing.
Hos patienter, der ikke oplevede søvnighed, ses en sådan forbedring hos 33% af patienterne behandlet med pregabalin og hos 18% af patienterne behandlet med placebo.
For patients not experiencing somnolence, such an improvement was observed in 33% of patients treated with pregabalin and 1 8% of patients on placebo.
I kontrollerede kliniske studier af centrale neuropatiske smerter ses en 50% forbedring i smertescore, hos 22% af patienterne behandlet med pregabalin og hos 7% af patienterne behandlet med placebo.
In the controlled clinical trial in central neuropathic pain 22% of the Pregabalin treated patients and 7% of the patients on placebo had a 50% improvement in pain score.
Epilepsi
8 Epilepsy
Pregabalin er undersøgt i 3 kontrollerede studier af 12 ugers varighed med dosering enten 2 eller 3 gange dagligt.
Pregabalin has been studied in 3 controlled clinical studies of 12 week duration with either twice a day dosing (BID) or three times a day (TID) dosing.
En reduktion i anfaldshyppighed ses efter 1 uge
A reduction in seizure frequency was observed by Week 1.
Pregabalin er undersøgt i 6 kontrollerede studier af 4- 6 ugers varighed, et studie med ældre af 8 ugers varighed og et langtids relaps- forebyggelsesstudie med en dobbelt- blind relaps- forebyggelsesfase af 6 måneders varighed.
Pregabalin has been studied in 6 controlled studies of 4-6 week duration, an elderly study of 8 week duration and a long-term relapse prevention study with a double blind relapse prevention phase of 6 months duration.
Der blev set lindring af symptomer på generaliseret angst, målt ved ” Hamilton Anxiety Rating Scale ” (HAM- A), efter 1 uge.
Relief of the symptoms of GAD as reflected by the Hamilton Anxiety Rating Scale (HAM-A) was observed by Week 1.
I de kontrollerede kliniske studier (af 4- 8 ugers varighed) opnåede 52% af patienterne behandlet med pregabalin og 38% af patienterne på placebo mindst en 50% forbedring i HAM- A totalscore fra baseline til endpoint.
In controlled clinical trials (4-8 week duration) 52% of the pregabalin treated patients and 38% of the patients on placebo had at least a 50% improvement in HAM-A total score from baseline to endpoint.
I de fleste tilfælde blev synet normaliseret efter fortsat behandling.
In controlled studies, a higher proportion of patients treated with pregabalin reported blurred vision than did patients treated with placebo which resolved in a majority of cases with continued dosing.
Synsskarpheden blev nedsat hos 6, 5% af disse patienter, der blev behandlet med pregabalin, og hos 4, 8% af placebobehandlede patienter.
In these patients, visual acuity was reduced in 6.5% of patients treated with pregabalin, and 4.8% of placebo-treated patients.
Synsfeltforandringer blev set hos 12, 4% af patienterne, der blev behandlet med pregabalin, og hos 11, 7% af placebobehandlede patienter.
Visual field changes were detected in 12.4% of pregabalin-treated, and 11.7% of placebo-treated patients.
Forandringer af øjenbaggrunden blev observeret hos 1, 7% af patienterne, der blev behandlet med pregabalin og 2, 1% af placebobehandlede patienter.
Funduscopic changes were observed in 1.7% of pregabalin-treated and 2.1% of placebo-treated patients.
Pregabalins steady- state farmakokinetik er ens hos raske forsøgspersoner, hos patienter med epilepsi i anti - epileptisk behandling og hos patienter med kroniske smerter.
Pregabalin steady-state pharmacokinetics are similar in healthy volunteers, patients with epilepsy receiving anti-epileptic drugs and patients with chronic pain.
9 Absorption:
Absorption:
Biotilgængeligheden af oral pregabalin anslås at være ≥90%, og er ikke dosisafhængig.
Pregabalin oral bioavailability is estimated to be ≥90% and is independent of dose.
Efter gentagne doser nås steady- state indenfor 24- 48 timer.
Following repeated administration, steady state is achieved within 24 to 48 hours.
25- 30% og en forsinkelse i tmax på ca.
The rate of pregabalin absorption is decreased when given with food resulting in a decrease in Cmax by approximately 25-30% and a delay in tmax to approximately 2.5 hours.
I prækliniske studier har det vist sig, at pregabalin krydser blod- hjernebarrieren hos mus, rotter og aber.
In preclinical studies, pregabalin has been shown to cross the blood brain barrier in mice, rats, and monkeys.
0, 56 l/ kg.
In humans, the apparent volume of distribution of pregabalin following oral administration is approximately 0.56 l/kg.
98% af radioaktiviteten i urinen som uomdannet pregabalin.
Following a dose of radiolabelled pregabalin, approximately 98% of the radioactivity recovered in the urine was unchanged pregabalin.
Det N- methylerede derivat af pregabalin, der er pregabalins hovedmetabolit, genfindes i urin og svarer til 0, 9% af dosis.
The N- methylated derivative of pregabalin, the major metabolite of pregabalin found in urine, accounted for
I prækliniske studier ses ingen tegn på racemisering af pregabalins S- enantiomer til R- enantiomer.
In preclinical studies, there was no indication of racemisation of pregabalin S- enantiomer to the R-enantiomer.
Pregabalins gennemsnitlige halveringstid er 6, 3 timer.
Pregabalin mean elimination half-life is 6.3 hours.
5. 2 Nedsat nyrefunktion).
Pregabalin plasma clearance and renal clearance are directly proportional to creatinine clearance (see section 5.2 Renal impairment).
4. 2 tabel 1).
Dosage adjustment in patients with reduced renal function or undergoing haemodialysis is necessary (see Section 4.2 Table 1).
Linearitet / non- linearitet:
Linearity / non-linearity:
Farmakokinetikken for gentagne doser kan forudsiges ud fra enkeltdosis- data.
Multiple dose pharmacokinetics are predictable from single-dose data.
Pregabalin- clearance er direkte proportionalt med kreatininclearance.
Pregabalin clearance is directly proportional to creatinine clearance.
50%).
In addition, pregabalin is effectively removed from plasma by haemodialysis (following a 4 hour haemodialysis treatment plasma pregabalin concentrations are reduced by approximately 50%).
4. 2 tabel 1).
Because renal elimination is the major elimination pathway, dosage reduction in patients with renal impairment and dosage supplementation following haemodialysis is necessary (see section 4.2 Table 1).
10 Nedsat leverfunktion
Hepatic impairment
Pregabalin- clearance falder ofte med øget alder, svarende til det fald i kreatininclearance, som skyldes øget alder.
This decrease in pregabalin oral clearance is consistent with decreases in creatinine clearance associated with increasing age.
4. 2 tabel 1).
Reduction of pregabalin dose may be required in patients who have age related compromised renal function (see section 4.2 Table 1).
I gentagne dosis- toksicitetsundersøgelser på rotter og aber ses påvirkning af centralnervesystemet, bl. a. ved hypoaktivitet, hyperaktivitet og ataksi.
In repeated dose toxicity studies in rats and monkeys CNS effects were observed, including hypoactivity, hyperactivity and ataxia.
En øget hyppighed af nethindeatrofi ses sædvanligvis hos ældre albinorotter efter langtidseksponering med pregabalin ved doser ≥5 gange den maksimale anbefalede gennemsnitlige humane dosis.
An increased incidence of retinal atrophy commonly observed in aged albino rats was seen after long term exposure to pregabalin at exposures≥ 5 times the mean human exposure at the maximum recommended clinical dose.
I præ- natale / post- natale toksicitetsundersøgelser fremkalder pregabalin udviklingstoksicitet hos afkom af rotter ved doser > 2 gange den maksimale anbefalede humane dosis.
10 pregabalin induced offspring developmental toxicity in rats at exposures > 2 times the maximum recommended human exposure.
Pregabalin er ikke genotoksisk på baggrund af in- vitro og in vivo tests.
Pregabalin is not genotoxic based on results of a battery of in vitro and in vivo tests.
2- års karcinogenicitetsforsøg er udført med pregabalin på rotter og mus.
Two-year carcinogenicity studies with pregabalin were conducted in rats and mice.
Der blev ikke set tumorer hos rotter ved en eksponering op til 24 gange den maksimale anbefalede gennemsnitlige humane dosis på 600 mg/ dag.
No tumours were observed in rats at exposures up to 24 times the mean human exposure at the maximum recommended clinical dose of 600 mg/day.
Den ikke- genotoksiske mekanisme af pregabalin- induceret tumordannelse hos mus involverer trombocytændringer og er forbundet med endotelcelleproliferation.
The non-genotoxic mechanism of pregabalin-induced tumour formation in mice involves platelet changes and associated endothelial cell proliferation.
Disse trombocytændringer er ikke til stede hos rotter eller hos mennesker baseret på kliniske korttids - eller begrænsede langtidsdata.
These platelet changes were not present in rats or in humans based on short term and limited long term clinical data.
Reduceret respons for akustisk forskrækkelse ses hos juvenile rotter 1- 2 uger efter doser > 2 gange højere end terapeutisk dosis hos mennesker.
Reduced acoustic startle response was observed in juvenile rats 1-2 weeks after exposure at > 2 times the human therapeutic exposure.
Lactosemonohydrat Majsstivelse Talcum
Lactose monohydrate Maize starch Talc
Gelatine Titandioxid (E171) Natriumlaurilsulfat Silica, kolloid vandfri Renset vand
Gelatin Titanium Dioxide (E171) Sodium Laurilsulphate Silica, colloidal anhydrous Purified water
Trykkeblæk:
Printing Ink:
Shellak Sort jernoxid (E172) Propylenglycol Kaliumhydroxid
Shellac Black Iron Oxide (E172) Propylene Glycol Potassium Hydroxide
Ingen særlige forholdsregler vedrørende opbevaringen.
This medicinal product does not require any special storage conditions
6. 5 Emballagetype og pakningsstørrelser
11 6.5 Nature and contents of container
PVC/ aluminiumblister, der indeholder 14, 21, 56, 84 eller 112 (2 x 56) hårde kapsler.
PVC/Aluminium blisters containing 14, 21, 56, 84 or 112 (2 x 56) hard capsules.
100 hårde kapsler i PVC/ aluminium blisterpakning (ikke perforeret).
100 x 1 hard capsules in PVC/Aluminium perforated unit dose blisters.
Ikke alle pakningsstørrelser er nødvendigvis markedsført.
Not all pack sizes may be marketed 100 hard capsule PVC/Aluminium blister pack (non-perforated)
6. 6 Regler for destruktion og anden håndtering Ingen særlige forholdsregler.
6.6 Special precautions for disposal and other handling
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ Storbritannien
Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ UK
EU/ 1/ 04/ 279/ 001- 05 EU/ 1/ 04/ 279/ 026 EU/ 1/ 04/ 279/ 036
EU/1/04/279/001-005 EU/1/04/279/026 EU/1/04/279/036
06/ 07/ 2004 Dato for seneste fornyelse:
06/07/2004 Date of last renewal:
LYRICA 50 mg hårde kapsler
LYRICA 50 mg hard capsules.
Hvide mærket ” Pfizer ” på overdelen og ” PGN 50 ” på underdelen med sort blæk.
Hard capsule White, marked “Pfizer” on the cap and “PGN 50” on the body with black ink.
14 Generaliseret angst
13 Generalised Anxiety Disorder
4. 8).
In accordance with current clinical practice, if pregabalin has to be discontinued, it is recommended this should be done gradually over a minimum of 1 week independent of the indication (see section 4.8).
Disse fremgår af tabel 1 og er udregnet med følgende formel:
⎡1.23 × [140 - age (years)] x weight (kg) ⎤
Kreatininclearance (ml/ min) =
CLcr(ml/min) =
Total daglig dosis pregabalin * Startdosis Maksimal dosis (mg/ døgn) (mg/ døgn)
Total Pregabalin Daily dose *
2 eller 3 gange dagligt
Starting dose (mg/day)
2 eller 3 gange dagligt
Maximum dose (mg/day)
≥15 - < 30
≥ 60 ≥30 - < 60 ≥15 - < 30 < 15
25 – 50 150
150 75 25 – 50 25
75
600 300 150 75
1 gang dagligt
BID or TID BID or TID Once Daily or BID Once Daily
Patienter med nedsat leverfunktion
14 Use in patients with hepatic impairment
15 Børn og unge
Use in children and adolescents
Der er ingen data tilgængelig vedrørende hyppighed og sværhedsgrad af seponeringssymptomer i relation til varighed og dosering af pregabalin i forbindelse med seponering af langtidsbehandling med pregabalin.
15 Concerning discontinuation of long-term treatment of pregabalin there are no data of the incidence and severity of withdrawal symptoms in relation to duration of use and dosage of pregabalin.
Disse hændelser er overvejende set hos ældre kardiovaskulært, kompromiterede
There have been post-marketing reports of congestive heart failure in some patients receiving pregabalin These reactions are mostly seen in elderly cardiovascular compromised patients during pregabalin treatment for a neuropathic indication.
17 4. 8 Bivirkninger
16 4.8 Undesirable effects
Sjælden Hyppighed ikke kendt
Rare Unknown frequency Eye disorders
18 Øjne Almindelig Ikke almindelig
Common Uncommon
Hyppighed ikke kendt Øre og labyrint
Unknown frequency
Almindelig Sjælden Hjerte
Ear and labyrinth disorders Common Rare Cardiac disorders
Atrioventrikulært blok af første grad, sinustakykardi, sinusbradykardi, sinusarytmi.
Tachycardia Atrioventricular block first degree, sinus tachycardia, sinus bradycardia, sinus arrhythmia,
Hypotension, hypertension, perifer kuldefølelse.
Flushing, hot flushes Hypotension, hypertension, peripheral coldness,
Stevens- Johnsons Syndrom, kløe.
Rash papular, sweating Urticaria, cold sweat Stevens Johnson syndrome, Pruritus
Almene symptomer og reaktioner på administrationsstedet Almindelig
General disorders and administration site conditions Common Uncommon Rare Unknown frequency Investigations
Gangforstyrrelser, følelse af beruselse, træthed, perifere ødemer, ødem.
Gait abnormal, feeling drunk, fatigue, oedema peripheral, oedema, Fall, chest tightness, asthenia, thirst Anasarca,pyrexia, rigors, pain exacerbated, Face oedema
Der er ingen data tilgængelig vedrørende hyppighed og sværhedsgrad af seponeringssymptomer i relation til varighed og dosering af pregabalin i forbindelse med seponering af langtidsbehandling med pregabalin.
18 Concerning discontinuation of long-term treatment of pregabalin there are no data of the incidence and severity of withdrawal symptoms in relation to duration of use and dosage of pregabalin.
Studier har vist effekt overfor diabetisk neuropati, post- herpetisk neuralgi og rygmarvskader.
Efficacy has been shown in studies in diabetic neuropathy,post herpetic neuralgia and spinal cord injury.
Pregabalin er undersøgt i 10 kontrollerede kliniske studier i op til 13 uger med dosering 2 gange dagligt, og i op til 8 uger med dosering 3 gange dagligt.
Pregabalin has been studied in 10 controlled clinical studies of up to 13 weeks with twice a day dosing (BID) and up to 8 weeks with three times a day (TID) dosing.