qanastek/EMEA-V3 huggingface dataset:
Funduscopic changes were observed in 1.7% of pregabalin-treated and 2.1% of placebo-treated patients.
Bdil funduskopiku kien innutat f’ 1. 7% ta ’ dawk trattati bi pregabalin u 2. 1% ta ’ pazjenti fuq plaċebo.
Pregabalin steady-state pharmacokinetics are similar in healthy volunteers, patients with epilepsy receiving anti-epileptic drugs and patients with chronic pain.
Il- farmakokinetiċi stabbli ta 'pregabalin huma simili f' voluntiera b' saħħithom, f' pazjenti bl- epilessija li jkunu qegħdin jieħdu mediċina kontra l- epilessija u f' pazjenti b' uġigħ kroniku.
Pregabalin is rapidly absorbed when administered in the fasted state, with peak plasma concentrations occurring within 1 hour following both single and multiple dose administration.
Pregabalin jiġi assorbit malajr meta jingħata f' pazjenti sajmin, bl- ogħla konċentrazzjonijiet fil- plasma jseħħu fi żmien siegħa wara li tingħata kemm doża waħda kif ukoll dożi multipli.
Pregabalin oral bioavailability is estimated to be ≥90% and is independent of dose.
Il- bijodisponibilità orali ta 'pregabalin hija stmata għal ≥90% u hija indipendenti mid- doża.
Following repeated administration, steady state is achieved within 24 to 48 hours.
Wara li jingħata diversi drabi, stat stabbli jinkiseb fi żmien 24 sa 48 siegħa.
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.
Ir- rata ta 'assorbiment ta' pregabalin tonqos meta jingħata ma 'l- ikel biex tirriżulta fi tnaqqis ta' madwar 20- 30% fil- Cmax u dewmien fit- tmax ta 'madwar 2. 5 sigħat.
However, administration of pregabalin with food has no clinically significant effect on the extent of pregabalin absorption.
Madankollu, l- amministrazzjoni ta 'pregabalin ma' l- ikel ma għandha l- ebda effett kliniku sinifikanti fuq il- livell ta 'assorbiment ta' pregabalin.
In preclinical studies, pregabalin has been shown to cross the blood brain barrier in mice, rats, and monkeys.
Fi studji ta 'qabel l- użu kliniku, instab li pregabalin jaqsam il- barriera ta' bejn id- demm u l- moħħ fil - ġrieden, firien u xadini.
Pregabalin has been shown to cross the placenta in rats and is present in the milk of lactating rats.
Fil- firien irriżulta li pregabalin għadda mill- plaċenta u huwa preżenti fil- ħalib ta 'firien li jreddgħu.
In humans, the apparent volume of distribution of pregabalin following oral administration is approximately 0.56 l/kg.
Fil- bniedem, il- volum apparenti tad- distribuzzjoni ta 'pregabalin wara li jiġi amministrat mill- ħalq huwa madwar 0. 56 l/ kg.
Pregabalin is not bound to plasma proteins.
Pregabalin ma jeħilx mal- proteini tal- plasma.
Pregabalin undergoes negligible metabolism in humans.
Il- metaboliżmu ta 'pregabalin fil- bniedem huwa negliġibbli.
Following a dose of radiolabelled pregabalin, approximately 98% of the radioactivity recovered in the urine was unchanged pregabalin.
Wara doża ta 'pregabalin radjutikkettat, madwar 98% tar- radjuattività rkuprata fl- awrina kien pregabalin mhux mibdul.
9 0.9% of the dose.
Id- derivattiv N - methylated ta 'pregabalin, li huwa l- metabolit prinċipali ta' pregabalin li nsibu fl- awrina, ammonta għal 0. 9% tad- doża.
In preclinical studies, there was no indication of racemisation of pregabalin S- enantiomer to the R-enantiomer.
Fi studji ta 'qabel l- użu kliniku, ma kien hemm l- ebda indikazzjoni ta' bidla ta 'S - enantiomer ta' pregalabin għal R- enantiomer.
Pregabalin mean elimination half-life is 6.3 hours.
Il- half life medja ta 'l- eliminazzjoni ta' pregabalin hija 6. 3 sigħat.
Pregabalin plasma clearance and renal clearance are directly proportional to creatinine clearance (see section 5.2 Renal impairment).
It- tneħħija ta 'pregabalin mill - plasma u t- tneħħija mill- kliewi huma direttament proporzjonali mat- tneħħija tal- krejatinina (ara sezzjoni 5. 2 Indeboliment tal- kliewi).
Dosage adjustment in patients with reduced renal function or undergoing haemodialysis is necessary (see Section 4.2 Table 1).
Huwa meħtieġ aġġustament tad- doża f' pazjenti li għandhom funzjoni renali mnaqqsa jew li jkunu qegħdin jagħmlu ħemodijaliżi (ara Sezzjoni 4. 2 Tabella 1).
Linearity / non-linearity:
10 Lineari / mhux lineari:
Pregabalin pharmacokinetics are linear over the recommended daily dose range.
Il- farmakokinetika ta 'pregabalin hi lineari fuq il- medda tad- doża rakkomandata tal- ġurnata.
Inter-subject pharmacokinetic variability for pregabalin is low (< 20%).
Il - varjabilità fil- farmakokinetika bejn persuna u oħra għal pregabalin hija baxxa (< 20%).
Multiple dose pharmacokinetics are predictable from single-dose data.
Il - farmakokinetiċi ta 'doża multipla jistgħu jiġu previsti minn informazzjoni dwar doża waħda.
Therefore, there is no need for routine monitoring of plasma concentrations of pregabalin.
Għalhekk, m' hemmx bżonn monitoraġġ regolari tal- konċentrazzjonijiet ta 'pregabalin fil- plasma.
Pharmacokinetics in special patient groups
Farmakokinetika fi gruppi speċjali ta 'pazjenti
Gender
Sess tal- persuna
Clinical trials indicate that gender does not have a clinically significant influence on the plasma concentrations of pregabalin.
Il- provi kliniċi jindikaw li s- sess tal- persuna m' għandux effett kliniku sinifikanti fuq il - konċentrazzjonijiet ta 'pregabalin fil- plasma.
Pregabalin clearance is directly proportional to creatinine clearance.
It- tneħħija ta 'pregabalin hija direttament proporzjonali mat- tneħħija tal- krejatinina.
In addition, pregabalin is effectively removed from plasma by haemodialysis (following a 4 hour haemodialysis treatment plasma pregabalin concentrations are reduced by approximately 50%).
Barra minn hekk, pregabalin jitneħħa b' mod effettiv mill- plasma permezz ta 'ħemodijaliżi (wara trattament ta' 4 sigħat b' ħemodijaliżi l- konċentrazzjonijiet ta 'pregabalin fil- plasma jonqsu b' madwar 50%).
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).
Minħabba li pregabalin jiġi eliminat fil- biċċa l- kbira tiegħu mill- kliewi, huwa meħtieġ tnaqqis tad- doża f' pazjenti b' indeboliment tal- kliewi u żieda fid- doża wara ħemodijaliżi (ara sezzjoni 4. 2 Tabella 1).
No specific pharmacokinetic studies were carried out in patients with impaired liver function.
Ma sarux studji speċifiċi dwar il- farmakokinetika f' pazjenti li għandhom funzjoni indebolita tal- fwied.
Since pregabalin does not undergo significant metabolism and is excreted predominantly as unchanged drug in the urine, impaired liver function would not be expected to significantly alter pregabalin plasma concentrations.
Billi pregabalin ma jiġix metabolizzat b' mod sinifikanti u jitneħħa fil- biċċa l- kbira bħala mediċina mhux mibdula fl- awrina, indeboliment fil- funzjoni tal- fwied mhux mistenni li jbiddel b' mod sinifikanti l- konċentrazzjonijiet ta 'pregabalin fil- plasma.
Elderly (over 65 years of age)
Anzjani ('il fuq minn 65 sena)
Pregabalin clearance tends to decrease with increasing age.
Hemm tendenza li t- tneħħija ta 'pregabalin tonqos aktar ma wieħed jikber fl- età.
This decrease in pregabalin oral clearance is consistent with decreases in creatinine clearance associated with increasing age.
Dan it- tnaqqis fit - tneħħija orali ta 'pregabalin huwa konsistenti mat- tnaqqis fit- tneħħija ta' krejatinina assoċjat mat - tkabbir fl- età.
Reduction of pregabalin dose may be required in patients who have age related compromised renal function (see section 4.2 Table 1).
Jista 'jkun meħtieġ tnaqqis fid- doża ta' pregabalin f' pazjenti li jkollhom funzjoni renali kompromessa marbuta ma 'l- eta (ara sezzjoni 4. 2 Tabella 1).
In conventional safety pharmacology studies in animals, pregabalin was well-tolerated at clinically relevant doses.
Fi studji konvenzjonali ta 'sigurtà farmakoloġika, pregabalin kien ittollerat b' mod tajjeb f' dożi klinikament rilevanti.
In repeated dose toxicity studies in rats and monkeys CNS effects were observed, including hypoactivity, hyperactivity and ataxia.
Fi studji dwar it- tossiċità b' dożi ripetuti kienu osservati effetti fuq is- CNS fil - firien u x- xadini, fosthom nuqqas ta 'attività, attività eċċessiva u atassja.
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.
Wara esponiment fit- tul għal pregabalin f' esponimenti ta '≥ 5 darbiet l- esponiment uman medju bid- doża klinika massima rakkomandata kienet osservata inċidenza akbar ta' atrofija tar- retina li normalment tidher f' firien albini xjuħ.
Pregabalin was not teratogenic in mice, rats or rabbits.
Pregabalin ma kienx teratoġeniku fil- ġrieden, firien jew fniek.
In prenatal/postnatal toxicity studies,
Fil- firien u l- fniek it- tossiċità tal- fetu seħħet biss b' esponimenti suffiċjentement ogħla mill- esponiment tal- bniedem.
10 pregabalin induced offspring developmental toxicity in rats at exposures > 2 times the maximum recommended human exposure.
Fi studji dwar it - tossiċità qabel/ wara t- twelid, pregabalin ikkawża tossiċità fl- iżvilupp tal- frieħ fil- firien f' esponimenti ta '> 2 darbiet l- esponiment massimu rakkomandat fil- bniedem.
Pregabalin is not genotoxic based on results of a battery of in vitro and in vivo tests.
Pregabalin mhux ġenotossiku skond ir- riżultati ta 'sensiela ta' testijiet in vitro u in vivo.
Two-year carcinogenicity studies with pregabalin were conducted in rats and mice.
Twettqu studji ta 'sentejn dwar il- karċinoġeniċità bi pregabalin fil- firien u l- ġrieden.
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.
Ma ġew osservati l- ebda tumuri fil- firien b' esponimenti sa 24 darba aktar mill- esponiment medju tal- bniedem bid- doża klinika massima rakkomandata ta '600 mg/ ġurnata.
In mice, no increased incidence of tumours was found at exposures similar to the mean human exposure, but an increased incidence of haemangiosarcoma was observed at higher exposures.
Fil- ġrieden, ma nstabet l- ebda inċidenza akbar ta 'tumuri f' esponimenti simili għall- esponiment medju tal- bniedem, iżda kienet osservata inċidenza akbar
The non-genotoxic mechanism of pregabalin-induced tumour formation in mice involves platelet changes and associated endothelial cell proliferation.
Il- mekkaniżmu mhux ġenotossiku tal- formazzjoni ta 'tumuri kkawżati minn pregabalin fil- ġrieden jinvolvi bidliet fil- pjastrini u proliferazzjoni taċ- ċelloli endotiljali assoċjati miegħu.
These platelet changes were not present in rats or in humans based on short term and limited long term clinical data.
Dawn il- bidliet fil- pjastrini ma kinux preżenti fil- firien u fil- bniedem skond informazzjoni klinika fuq perijodu qasir u perijodu twil limitat.
There is no evidence to suggest an associated risk to humans.
M' hemmx evidenza biex tissuġġerixxi riskju assoċjat fil- bniedem.
In juvenile rats the types of toxicity do not differ qualitatively from those observed in adult rats.
It- tipi ta 'tossiċità fil- firien żgħar mhumiex differenti minn dawk osservati fil- firien adulti.
However, juvenile rats are more sensitive.
Madankollu, il- firien żgħar huma aktar sensittivi.
At therapeutic exposures, there was evidence of CNS clinical signs of hyperactivity and bruxism and some changes in growth (transient body weight gain suppression).
B' esponimenti terapewtiċi, kien hemm evidenza ta 'sinjali kliniċi tas- CNS ta' attività eċċessiva u tgħażżiż tas- snien u xi bidliet fit- tkabbir (trażżiż temporanju taż- żieda fil- piż tal- ġisem).
Effects on the oestrus cycle were observed at 5-fold the human therapeutic exposure.
Kienu osservati effetti fuq iċ- ċiklu ta 'l- oestrus b' esponimenti 5 darbiet akbar mill- esponiment terapewtiku fil- bniedem.
Reduced acoustic startle response was observed in juvenile rats 1-2 weeks after exposure at > 2 times the human therapeutic exposure.
Kien osservat rispons imnaqqas ta 'ħasda għall- ħoss f' firien żgħar ġimgħa sa ġimagħtejn wara esponiment > darbtejn aktar mill- esponiment terapewtiku fil- bniedem.
Nine weeks after exposure, this effect was no longer observable.
Disa 'ġimgħat wara l- esponiment, dan l- effett ma kienx jidher aktar.
Lactose monohydrate Maize starch Talc
Lactose monohydrate Maize starch Talkum
Gelatin Titanium Dioxide (E171) Sodium Laurilsulphate Silica, colloidal anhydrous Purified water
Ġelatina Titanium Dioxide (E171) Sodium Laurilsulphate Silica, colloidal anhydrous Ilma ppurifikat
Printing Ink:
Linka ta 'l- istampar:
Shellac Black Iron Oxide (E172) Propylene Glycol Potassium Hydroxide
Shellac Iron Oxide Iswed (E172) Propylene Glycol Potassium Hydroxide
11 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta 'dak li hemm ġo fih
PVC/Aluminium blisters containing 14, 21, 56, 84 or 112 (2 x 56) hard capsules.
Folji tal- PVC/ Aluminju li fihom 14, 21, 56, 84 jew 112 (2 x 56) kapsula iebsa.
100 x 1 hard capsules in PVC/Aluminium perforated unit dose blisters.
100 x 1 kapsula iebsa f' folji ta ’ doża waħda perforati tal- PVC/ Aluminju.
Not all pack sizes may be marketed 100 hard capsule PVC/Aluminium blister pack (non-perforated)
100 kapsula iebsa, f’ folji (mhux perforati) ġo pakkett tal- PVC/ Aluminju Jista 'jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ UK
Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ Ir- Renju Unit
06/07/2004 Date of last renewal:
06/ 07/ 2004 Data ta 'l- aħħar tiġdid:
LYRICA 50 mg hard capsules.
LYRICA 50 mg kapsuli iebsin
Each hard capsule contains 50 mg of pregabalin.
Kull kapsula iebsa fiha 50 mg ta 'pregabalin.
Hard capsule White, marked “Pfizer” on the cap and “PGN 50” on the body with black ink.
Kapsula iebsa Bajda, immarkata “ Pfizer ” fuq il- parti ta 'fuq u “ PGN 50 ” fuq il- parti ewlenija b' linka sewda.
The body is also marked with a black band.
Il- parti ewlenija hi mmarkata wkoll b' faxxa sewda.
The dose range is 150 to 600 mg per day given in either two or three divided doses.
L- ammont ta 'doża li jista' jittieħed huwa bejn 150 u 600 mg kuljum imqassmin f' żewġ dożi jew tlieta.
13 Generalised Anxiety Disorder
14 Disturb ta 'Ansjetà Ġeneralizzata
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).
Konformi ma 'prattika klinika kurrenti, jekk ikun hemm bżonn li pregabalin jiġi mwaqqaf, huwa rakkomandat li dan isir fuq perijodu minimu ta' ġimgħa indipendentement mill- indikazzjoni (ara sezzjoni 4. 8).
As pregabalin clearance is directly proportional to creatinine clearance (see section 5.2), dosage reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr), as indicated in Table 1 determined using the following formula:
Billi t- tneħħija ta 'pregabalin hija direttament proporzjonali mat- tneħħija tal - kreatinina (ara sezzjoni 5. 2), it- tnaqqis fid- doża f' pazjenti b' funzjoni renali kompromessa jrid ikun individwalizzat skond it- tneħħija tal- kreatinina (CLcr), kif indikat f' Tabella 1 stabbilit billi tintuża l - formula li ġejja:
⎡1.23 × [140 - age (years)] x weight (kg) ⎤
⎡1. 23 × [140 - age (years)] x weight (kg) ⎤ ⎥ (x 0. 85 for female patients) CLcr( ml/ min) = ⎢ ⎥
Table 1.
15 Tabella 1.
Total Pregabalin Daily dose *
Tneħħija tal - krejatinina
Dose Regimen
(CLcr) (mL/ min)
Starting dose (mg/day)
Doża Totali ta 'Pregabilin Kuljum * Doża inizjali Doża massima (mg/ ġurnata) (mg/ ġurnata)
Maximum dose (mg/day)
Reġim tad- Doża
150 75 25 – 50 25
150 600 75 300 25 – 50 150
14 Use in patients with hepatic impairment
Użu f' pazjenti b' indeboliment tal- fwied
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.
Fi studji kontrollati, proporzjon ogħla ta ’ pazjenti ttrattati bi pregabalin irrappurtaw viżjoni mċajpra milli dawk ttrattati bi plaċebo, u fil- biċċa ‘ l kbira tal- pazjenti il- viżjoni iċċarat meta tkompla id - 16 dużaġġ.
In the clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the incidence of fundoscopic changes was greater in placebo-treated patients (See section 5.1).
Fl- istudji kliniċi fejn saru testijiet oftalmoloġiċi, l- inċidenza ta ’ tnaqqis ta ’ l- akuita ’ viżiva u bdil fil- kamp viżwali kienu aktar f’ pazjenti fuq kura bi preglabalin milli f’ pazjenti fuq plaċebo; l - inċidenza ta ’ bdil fundoskopiku kien ogħla minn f’ pazjenti ttrattati bi plaċebo (Ara sezzjoni 5. 1).
In the postmarketing experience, visual adverse reactions have also been reported, most of which refer to transient visual blurring or other changes of visual acuity.
Fl- esperjenza ta ’ wara t- tqegħid fis- suq, reazzjonijiet avversi viżwali ġew ukoll irrappurtati, li jirreferu l- iktar għal viżjoni temporanjament imċajpra, jew kull tip ta ’ bdil ieġor fl- akuita ’ viżiiva.
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.
Rigward it- twaqqif ta 'kura fuq perijodu fit- tul ta' pregabalin m' hemmx informazzjoni dwar l- inċidenza u s- severità tas- sintomi ta 'l- irtirar tal- mediċina b' rabta mat- tul ta' l- użu u d- doża ta 'pregabalin.
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.
Dawn ir- reazzjonijiet jidhru l- aktar fl- anzjani bi problemi kardjovaskulari waqt trattament bi pregabalin għal indikazzjoni newropatika.
Pregabalin should be used with caution in these patients.
Pregabalin għandu jintuża b’ attenzjoni f’ dawn il- pazjenti.
Discontinuation of pregabalin may resolve the reaction..
Twaqqif ta ’ pregabalin jista jfejjaq ir- reazzjoni.
Pregabalin may potentiate the effects of ethanol and lorazepam.
Pregabalin jista ’ jżid l- effetti ta ’ ethanol u lorazepam.
In controlled clinical trials, multiple oral doses of pregabalin co- administered with oxycodone, lorazepam, or ethanol did not result in clinically important effects on respiration.
Fi studji kliniċi kkontrollati, dożi orali multipli ta 'pregabalin mogħtija flimkien ma' oxycodone, lorazepam, jew ethanol ma rriżultawx f' effetti klinikament importanti fuq ir- respirazzjoni.
In the postmarketing experience, there are reports of respiratory failure and coma in patients taking pregabalin and other CNS depressant medications.
F ’ esperjenza ta ’ wara t- tqegħid fis- suq, kien hemm rapporti ta ’ insuffiċjenza respiratorja u koma f ’ pazjenti li kienu qed jieħdu pregabalin u mediċini oħra
16 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Body System Immune system disorders
18 Sistema tal- Ġisem Disturbi fis- sistema immuni
Metabolism and nutrition disorders Common Uncommon Rare Psychiatric disorders
Frekwenza mhux magħrufa Sensittività eċċessiva, anġoedema reazzjoni allerġika Disturbi tad- demm u tas- sistema limfatika Rari Neutropenia Disturbi fil- metaboliżmu u n- nutrizzjoni Komuni Mhux komuni Rari Disturbi psikjatriċi
Rare Unknown frequency Eye disorders
Ipokinesja, parosmia, disgrafija
Hypokinesia, parosmia, dysgraphia Loss of consciousness, mental impairment, headache
Frekwenza mhux magħrufa Ħass ħażin, indeboliment mentali, uġigħ ta 'ras Disturbi fl- għajnejn Komuni Mhux komuni
Ear and labyrinth disorders Common Rare Cardiac disorders
Frekwenza mhux magħrufa Keratite Disturbi fil- widnejn u fis- sistema labirintika Komuni Rari Disturbi fil- qalb
Tachycardia Atrioventricular block first degree, sinus tachycardia, sinus bradycardia, sinus arrhythmia,
Takikardija Imblokk atrijoventrikolari ta 'l- ewwel grad, sinus tachycardia, sinus bradycardia, sinus arrhythmia
Flushing, hot flushes Hypotension, hypertension, peripheral coldness,
Fwawar, fwawar tal- menopawsa Pressjoni baxxa, pressjoni għolja, kesħa periferali
Common Uncommon
19 Disturbi gastro- intestinali Komuni Mhux komuni
Rash papular, sweating Urticaria, cold sweat Stevens Johnson syndrome, Pruritus
Raxx bl- infafet, tagħriq Urtikarja, għaraq kiesaħ
Gait abnormal, feeling drunk, fatigue, oedema peripheral, oedema, Fall, chest tightness, asthenia, thirst Anasarca,pyrexia, rigors, pain exacerbated, Face oedema
Mixja anormali, sensazzjoni ta 'wieħed fis- sakra, għeja, edema periferali, edema
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.
Rigward it- twaqqif ta 'kura fuq perijodu fit- tul ta' pregabalin m' hemmx informazzjoni dwar l- inċidenza u s- severità tas- sintomi ta 'l- irtirar tal- mediċina b' rabta mat- tul ta' l- użu u d- doża ta 'pregabalin.
Treatment of pregabalin overdose should include general supportive measures and may include haemodialysis if necessary (see section 4.2 Table 1).
20 Il- kura ta 'doża eċċessiva ta' pregabalin għandha tinkludi miżuri ġenerali ta 'sostenn u tista' tinkludi ħemodijaliżi jekk ikun meħtieġ (ara sezzjoni 4. 2 Tabella 1).
Efficacy has been shown in studies in diabetic neuropathy,post herpetic neuralgia and spinal cord injury.
Ġiet murija effikaċja fi studji dwar newropatija dijabetika, post herpetic neuralgia u leżjoni tal- korda spinali.
In clinical trials up to 12 weeks for both peripheral and central neuropathic pain, a reduction in pain was seen by week 1 and was maintained throughout the treatment period.
Fi provi kliniċi li damu sa 12- il ġimgħa kemm għal uġigħ nevrotiku periferali kif ukoll ċentrali, deher tnaqqis fl- uġigħ ma 'l- ewwel ġimgħa u nżamm tul il- perijodu kollu li damet il- kura.
For patients not experiencing somnolence, such an improvement was observed in 33% of patients treated with pregabalin and 18% of patients on placebo.
Fil- każ tal- pazjenti li ma esperjenzawx ngħas, dan it- titjib kien osservat fi 33% tal- pazjenti kkurati bi pregabalin u fi 18% tal - pazjenti fuq il- plaċebo.
19 A reduction in seizure frequency was observed by Week 1.
Kien osservat tnaqqis fil- frekwenza ta 'l- aċċessjonijiet ma' l- Ewwel Ġimgħa.
Relief of the symptoms of GAD as reflected by the Hamilton Anxiety Rating Scale (HAM-A) was observed by Week 1
Solliev tas- sintomi ta 'GAD kif rifless mill- Iskala ta' Hamilton għal- Livell ta 'Ansjetà (HAM- A) kien osservat ma' l- Ewwel Ġimgħa.
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.
21 Fi provi kliniċi kkontrollati (li damu 4- 8 ġimgħat) 52% tal- pazjenti kkurati bi pregabalin u 38% tal - pazjenti fuq il- plaċebo kellhom titjib ta 'mill- anqas 50% fil- punteġġ totali tal- HAM- A mil- linja bażika sal- punt finali.
The N- methylated derivative of pregabalin, the major metabolite of pregabalin found in urine, accounted for 0.9% of the dose.
Id- derivattiv N - methylated ta 'pregabalin, li huwa l- metabolit prinċipali ta' pregabalin li nsibu fl- awrina, ammonta għal 0. 9% tad- doża.
20 Pregabalin mean elimination half-life is 6.3 hours.
Il- half life medja ta 'l- eliminazzjoni ta' pregabalin hija 6. 3 sigħat.
Linearity / non-linearity:
22 Lineari / mhux lineari:
Foetal toxicity in rats and rabbits occurred only at exposures sufficiently above human exposure.
Fil- firien u l- fniek it- tossiċità tal- fetu seħħet biss b' esponimenti suffiċjentement ogħla mill- esponiment tal- bniedem.
In prenatal/postnatal toxicity studies, pregabalin induced offspring developmental toxicity in rats at exposures > 2 times the maximum recommended human exposure.
Fi studji dwar it - tossiċità qabel/ wara t- twelid, pregabalin ikkawża tossiċità fl- iżvilupp tal- frieħ fil- firien f' esponimenti ta '> 2 darbiet l- esponiment massimu rakkomandat fil- bniedem.
21 Two-year carcinogenicity studies with pregabalin were conducted in rats and mice.
Twettqu studji ta 'sentejn dwar il- karċinoġeniċità bi pregabalin fil- firien u l- ġrieden.
PVC/Aluminium blisters containing 14, 21, 56 or 84 hard capsules.
Folji tal- PVC/ Aluminju li fihom 14, 21, 56 jew 84 kapsula iebsa.
100 hard capsule PVC/Aluminium blister pack (non-perforated) Not all pack sizes may be marketed
100 kapsula iebsa, f’ folji (mhux perforati) ġo pakkett tal- PVC/ Aluminju Jista 'jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
22 6.6 Special precautions for disposal and other handling
24 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
LYRICA 75 mg hard capsules
LYRICA 75 mg kapsuli iebsin
Each hard capsule contains 75 mg of pregabalin.
Kull kapsula iebsa fiha 75 mg ta 'pregabalin.
Hard capsule White and orange, marked “Pfizer” on the cap and “PGN 75” on the body with black ink.
Kapsula iebsa Bajda u oranġjo, immarkata “ Pfizer ” fuq il- parti ta 'fuq u “ PGN 75 ” fuq il- parti ewlenija b' linka sewda.
Generalised Anxiety Disorder
26 Disturb ta 'Ansjetà Ġeneralizzata
24 Pregabalin treatment can be started with a dose of 150 mg per day.
Il- kura bi pregabalin tista 'tinbeda b' doża ta' 150 mg kuljum.
Table 1.
27 Tabella 1.
Use in patients with hepatic impairment
Użu f' pazjenti b' indeboliment tal- fwied
25 Use in the elderly (over 65 years of age)
Użu fl- anzjani ('il fuq minn 65 sena)
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.
Fi studji kontrollati, proporzjon ogħla ta ’ pazjenti ttrattati bi pregabalin irrappurtaw viżjoni mċajpra milli dawk ttrattati bi plaċebo, u fil- biċċa ‘ l kbira tal- pazjenti il- viżjoni iċċarat meta tkompla id - 28 dużaġġ.
26 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.
Fil- kura ta 'uġigħ nevrotiku ċentali minħabba leżjoni fil- korda spinali l- inċidenza ta' episodji avversi b' mod ġenerali, episodji avversi tas- CNS u b' mod speċjali tan- ngħas żdiedet.
Pregabalin may potentiate the effects of ethanol and lorazepam.
Pregabalin jidher li hu addittiv fl- indeboliment tal- funzjoni konoxxittiva u motorja globali kkawżat minn oxycodone.
The most common adverse
Fl- istudji kollha kkontrollati, ir- rata tat - twaqqif minħabba reazzjonijiet avversi kienet 13% għall- pazjenti li kienu qegħdin jirċievu pregabalin u 7% għall- pazjenti li kienu qegħdin jirċievu l- plaċebo.
27 reactions resulting in discontinuation from pregabalin treatment groups were dizziness and somnolence.
L- aktar reazzjonijiet avversi komuni li rriżultaw fi twaqqif minn gruppi tal- kura bi pregabalin kienu sturdament u ngħas.
Body System Immune system disorders
30 Sistema tal- Ġisem Disturbi fis- sistema immuni
Hypersensitivity,angioedema, allergic reaction
Reazzjonijiet avversi għall- mediċina
Blood and lymphatic system disorders Rare Neutropenia Metabolism and nutrition disorders Common Uncommon Rare Psychiatric disorders
Frekwenza mhux magħrufa Sensittività eċċessiva, anġoedema, reazzjoni allerġika Disturbi tad- demm u tas- sistema limfatika Rari Neutropenia Disturbi fil- metaboliżmu u n- nutrizzjoni Komuni Mhux komuni Rari Disturbi psikjatriċi
Vision blurred, diplopia Visual disturbance, eye swelling, visual field defect, visual acuity reduced, eye pain, asthenopia, dry eye, lacrimation increased
Vista mċajpra, vista doppja Disturb viżwali, nefħa fl- għajnejn, difett fil- kamp viżwaliakutezza viżwali mnaqqsa, uġigħ fl- għajnejn, astenopja, għajnejn xotti, tidmigħ aktar
28 Cardiac disorders Uncommon Rare
Mhux komuni Rari
Common Uncommon
31 Disturbi gastro- intestinali Komuni Mhux komuni
Gait abnormal, feeling drunk, fatigue, oedema peripheral, oedema, Fall, chest tightness, asthenia, thirst Anasarca, pyrexia, rigors, pain exacerbated Face oedema
Mixja anormali, sensazzjoni ta 'wieħed fis- sakra, għeja, edema periferali, edema
The following events have been mentioned: insomnia, headache, nausea, diarrhoea, flu syndrome, nervousness, depression, pain, sweating, and dizziness.
Kienu msemmija l- episodji li ġejjin: nuqqas ta 'rqad, uġigħ ta' ras, dardir, dijarea, sindrome ta 'l- influwenza, nervożità, depressjoni, uġigħ, tagħriq u sturdament.
29 4.9 Overdose
4. 9 Doża eċċessiva
Treatment of pregabalin overdose should include general supportive measures and may include haemodialysis if necessary (see section 4.2 Table 1).
32 Il- kura ta 'doża eċċessiva ta' pregabalin għandha tinkludi miżuri ġenerali ta 'sostenn u tista' tinkludi ħemodijaliżi jekk ikun meħtieġ (ara sezzjoni 4. 2 Tabella 1).
30 Generalised Anxiety Disorder
Disturb ta 'Ansjetà Ġeneralizzata
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.
33 Fi provi kliniċi kkontrollati (li damu 4- 8 ġimgħat) 52% tal- pazjenti kkurati bi pregabalin u 38% tal - pazjenti fuq il- plaċebo kellhom titjib ta 'mill- anqas 50% fil- punteġġ totali tal- HAM- A mil- linja bażika sal- punt finali.
31 Dosage adjustment in patients with reduced renal function or undergoing haemodialysis is necessary (see Section 4.2 Table 1).
Huwa meħtieġ aġġustament tad- doża f' pazjenti li għandhom funzjoni renali mnaqqsa jew li jkunu qegħdin jagħmlu ħemodijaliżi (ara Sezzjoni 4. 2 Tabella 1).
Linearity / non-linearity:
34 Lineari / mhux lineari:
In mice, no increased incidence of tumours was found at exposures
Fil- ġrieden, ma nstabet l- ebda inċidenza akbar ta 'tumuri f' esponimenti simili għall- esponiment medju tal- bniedem, iżda kienet osservata inċidenza akbar
32 similar to the mean human exposure, but an increased incidence of haemangiosarcoma was observed at higher exposures.
35 ta 'haemangiosarcoma f' esponimenti aktar għoljin.
Gelatin Titanium Dioxide (E171) Sodium Laurilsulphate Silica, colloidal anhydrous Purified water Red Iron Oxide (E172)
Ġelatina Titanium Dioxide (E171) Sodium Laurilsulphate Silica, colloidal anhydrous Ilma ppurifikat Iron Oxide Aħmar (E172)
PVC/Aluminium blisters containing 14, 56 or 112 (2 x 56) hard capsules.
Folji tal- PVC/ Aluminju li fihom 14, 56 jew 112 (2 x 56) kapsula iebsa.
100 hard capsule PVC/Aluminium blister pack (non-perforated) HDPE bottle containing 200 hard capsules.
100 kapsula iebsa, f’ folji (mhux perforati) ġo pakkett tal- PVC/ Aluminju Flixkun tal- HDPE li fih 200 kapsula iebsa.
Not all pack sizes may be marketed
Jista 'jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
33 6.6 Special precautions for disposal and other handling
36 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
LYRICA 100 mg hard capsules.
LYRICA 100 mg kapsuli iebsin.
Each hard capsule contains 100 mg of pregabalin.
Kull kapsula iebsa fiha 100 mg ta 'pregabalin.
Hard capsule Orange, marked “Pfizer” on the cap and “PGN 100” on the body with black ink.
Kapsula iebsa Oranġjo, immarkata “ Pfizer ” fuq il- parti ta 'fuq u “ PGN 100 ” fuq il- parti ewlenija b' linka sewda.
35 Generalised Anxiety Disorder
38 Disturb ta 'Ansjetà Ġeneralizzata
⎥ ⎦
età (snin) piż (kg) krejatinina fis- serum għal pazjenti nisa
Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours).
Pregabilin jitneħħa b' mod effettiv mill- plasma b' ħemodijaliżi (50% tal- mediċina f' 4 sigħat).
For patients receiving haemodialysis, the pregabalin daily dose should be adjusted based on renal function.
Fil- każ ta 'pazjenti li jkunu qegħdin jirċievu ħemodijaliżi, id- doża tal- ġurnata ta' pregabalin għandha tiġi aġġustata skond il- funzjoni renali.
Table 1.
39 Tabella 1.
36 Use in children and adolescents
Użu fit- tfal u l- adoloxxenti
Lyrica is not recommended for use in children below the age of 12 years and adolescents (12 – 17 years of age) due to insufficient data on safety and efficacy (see section 5.3).
Lyrica mhux irrakkomandat għall- użu fit- tfal ta 'taħt it- 12 - il sena u l- adoloxxenti (12- 17 - il sena) peress li m' hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 3).
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.
Fi studji kontrollati, proporzjon ogħla ta ’ pazjenti ttrattati bi pregabalin irrappurtaw viżjoni mċajpra milli dawk ttrattati bi plaċebo, u fil- biċċa ‘ l kbira tal- pazjenti il- viżjoni iċċarat meta tkompla id - 40 dużaġġ.
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
Kien hemm rapporti wara t- tqegħid fis- suq ta 'insuffiċjenza tal- qalb konġestiva f' xi pazjenti li kienu qegħdin jirċievu pregabalin.
37 pregabalin treatment for a neuropathic indication.
Dawn ir- reazzjonijiet jidhru l- aktar fl- anzjani bi problemi kardjovaskulari waqt trattament bi pregabalin għal indikazzjoni newropatika.
The most commonly reported adverse
Il- programm kliniku ta 'pregabalin kien jinvolvi' l fuq minn 9000 pazjent li kienu esposti għal pregabalin, li minnhom aktar minn 5000 kienu fi provi double- blind ikkontrollati bil- plaċebo.
38 reactions were dizziness and somnolence.
L- aktar reazzjonijiet avversi li ġew irrapportati b' mod komuni kienu sturdament u ngħas.
Body System Immune system disorders
42 Sistema tal- Ġisem Disturbi fis- sistema immuni
Hypersensitivity, angioedema, allergic reaction
Reazzjonijiet avversi għall- mediċina
39 Cardiac disorders Uncommon Rare
Mhux komuni Rari
Common Uncommon
43 Disturbi gastro- intestinali Komuni Mhux komuni
Treatment of pregabalin overdose should include general supportive measures and may include haemodialysis if necessary (see section 4.2 Table 1).
44 Il- kura ta 'doża eċċessiva ta' pregabalin għandha tinkludi miżuri ġenerali ta 'sostenn u tista' tinkludi ħemodijaliżi jekk ikun meħtieġ (ara sezzjoni 4. 2 Tabella 1).
41 Generalised Anxiety Disorder
Disturb ta 'Ansjetà Ġeneralizzata
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.
45 Fi provi kliniċi kkontrollati (li damu 4- 8 ġimgħat) 52% tal- pazjenti kkurati bi pregabalin u 38% tal - pazjenti fuq il- plaċebo kellhom titjib ta 'mill- anqas 50% fil- punteġġ totali tal- HAM- A mil- linja bażika sal- punt finali.
42 Dosage adjustment in patients with reduced renal function or undergoing haemodialysis is necessary (see Section 4.2 Table 1).
Huwa meħtieġ aġġustament tad- doża f' pazjenti li għandhom funzjoni renali mnaqqsa jew li jkunu qegħdin jagħmlu ħemodijaliżi (ara Sezzjoni 4. 2 Tabella 1).
Linearity / non-linearity:
46 Lineari / mhux lineari:
43 similar to the mean human exposure, but an increased incidence of haemangiosarcoma was observed at higher exposures.
47 ta 'haemangiosarcoma f' esponimenti aktar għoljin.
PVC/Aluminium blisters containing 21or 84 hard capsules.
Folji tal- PVC/ Aluminju li fihom 21 jew 84 kapsula iebsa.
100 hard capsule PVC/Aluminium blister pack (non-perforated)
100 kapsula iebsa, f’ folji (mhux perforati) ġo pakkett tal- PVC/ Aluminju Jista 'jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
44 6.6 Special precautions for disposal and other handling
48 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
LYRICA 150 mg hard capsules
LYRICA 150 mg kapsuli iebsin
Each hard capsule contains 150 mg of pregabalin.
Kull kapsula iebsa fiha 150 mg ta 'pregabalin.
Hard capsule White, marked “Pfizer” on the cap and “PGN 150” on the body with black ink.
Kapsula iebsa Bajda, immarkata “ Pfizer ” fuq il- parti ta 'fuq u “ PGN 150 ” fuq il- parti ewlenija b' linka sewda.
46 Generalised Anxiety Disorder
50 Disturb ta 'Ansjetà Ġeneralizzata
Table 1.
51 Tabella 1.
47 Lyrica is not recommended for use in children below the age of 12 years and adolescents (12 – 17 years of age) due to insufficient data on safety and efficacy (see section 5.3).
Lyrica mhux irrakkomandat għall- użu fit- tfal ta 'taħt it- 12 - il sena u l- adoloxxenti (12- 17 - il sena) peress li m' hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 3).
In the clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the incidence of fundoscopic changes was greater in placebo-treated patients (See section 5.1).
Fl- istudji kliniċi fejn saru testijiet oftalmoloġiċi, l- inċidenza ta ’ tnaqqis ta ’ l- akuita ’ viżiva u 52 bdil fil- kamp viżwali kienu aktar f’ pazjenti fuq kura bi preglabalin milli f’ pazjenti fuq plaċebo; l - inċidenza ta ’ bdil fundoskopiku kien ogħla minn f’ pazjenti ttrattati bi plaċebo (Ara sezzjoni 5. 1).
48 Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.
Pazjenti bi problemi ereditarji serji ta 'intolleranza għall- galattosju, il- Lapp lactase deficiency jew assorbiment ħażin tal- glukosju- galattosju m' għandhomx jieħdu din il- mediċina.
49 patients receiving pregabalin and 7% for patients receiving placebo.
Fl- istudji kollha kkontrollati, ir- rata tat - twaqqif minħabba reazzjonijiet avversi kienet 13% għall- pazjenti li kienu qegħdin jirċievu pregabalin u 7% għall- pazjenti li kienu qegħdin jirċievu l- plaċebo.
Body System Immune system disorders
54 Sistema tal- Ġisem Disturbi fis- sistema immuni
Rare Unknown frequency Eye disorders
Rari Frekwenza mhux magħrufa Disturbi fl- għajnejn
Hypokinesia, parosmia, dysgraphia Loss of consciousness, mental impairment, headache
Ipokinesja, parosmia, disgrafija Ħass ħażin, indeboliment mentali, uġigħ ta 'ras
50 Cardiac disorders Uncommon Rare
Mhux komuni Rari
Common Uncommon
55 Disturbi gastro- intestinali Komuni Mhux komuni
Musculoskeletal and connective tissue disorders Uncommon
Frekwenza mhux magħrufa Sindrome Stevens Johnson,, Ħakk Disturbi muskolu- skeltrali u tal- connective tissue Mhux komuni
Uncommon Rare Unknown frequency
Mard fil- kliewi u fis- sistema urinarja Mhux komuni Rari
Treatment of pregabalin overdose should include general supportive measures and may include haemodialysis if necessary (see section 4.2 Table 1).
56 Il- kura ta 'doża eċċessiva ta' pregabalin għandha tinkludi miżuri ġenerali ta 'sostenn u tista' tinkludi ħemodijaliżi jekk ikun meħtieġ (ara sezzjoni 4. 2 Tabella 1).
52 Generalised Anxiety Disorder
Disturb ta 'Ansjetà Ġeneralizzata
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.
57 Fi provi kliniċi kkontrollati (li damu 4- 8 ġimgħat) 52% tal- pazjenti kkurati bi pregabalin u 38% tal - pazjenti fuq il- plaċebo kellhom titjib ta 'mill- anqas 50% fil- punteġġ totali tal- HAM- A mil- linja bażika sal- punt finali.
53 Dosage adjustment in patients with reduced renal function or undergoing haemodialysis is necessary (see Section 4.2 Table 1).
Huwa meħtieġ aġġustament tad- doża f' pazjenti li għandhom funzjoni renali mnaqqsa jew li jkunu qegħdin jagħmlu ħemodijaliżi (ara Sezzjoni 4. 2 Tabella 1).
Linearity / non-linearity:
58 Lineari / mhux lineari:
54 similar to the mean human exposure, but an increased incidence of haemangiosarcoma was observed at higher exposures.
59 ta 'haemangiosarcoma f' esponimenti aktar għoljin.
PVC/Aluminium blisters containing 14,56 or 112 (2 x 56) hard capsules.
Folji tal- PVC/ Aluminju li fihom 14, 56 jew 112 (2 x 56) kapsula iebsa.
55 6.6 Special precautions for disposal and other handling
60 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
LYRICA 200 mg hard capsules
LYRICA 200 mg kapsuli iebsin
Each hard capsule contains 200 mg of pregabalin.
Kull kapsula iebsa fiha 200 mg ta 'pregabalin.
Hard capsule Light orange, marked “Pfizer” on the cap and “PGN 200” on the body with black ink.
Kapsula iebsa Oranġjo ċar, immarkata “ Pfizer ” fuq il- parti ta 'fuq u “ PGN 200 ” fuq il- parti ewlenija b' linka sewda.
57 Generalised Anxiety Disorder
62 Disturb ta 'Ansjetà Ġeneralizzata
Table 1.
63 Tabella 1.
58 Use in children and adolescents
Użu fit- tfal u l- adoloxxenti
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.
Fi studji kontrollati, proporzjon ogħla ta ’ pazjenti ttrattati bi pregabalin irrappurtaw viżjoni mċajpra milli dawk ttrattati bi plaċebo, u fil- biċċa ‘ l kbira tal- pazjenti il- viżjoni iċċarat meta tkompla id - 64 dużaġġ.
59 pregabalin treatment for a neuropathic indication.
Dawn ir- reazzjonijiet jidhru l- aktar fl- anzjani bi problemi kardjovaskulari waqt trattament bi pregabalin għal indikazzjoni newropatika.
In teraction studies have only been performed in adults.
Studji dwar l - effett ta 'mediċini jew ta' affarijiet oħra fuq l- effett farmaċewtiku tal- prodott saru biss fl- adulti.
60 reactions were dizziness and somnolence.
L- aktar reazzjonijiet avversi li ġew irrapportati b' mod komuni kienu sturdament u ngħas.
Body System Immune system disorders
66 Sistema tal- Ġisem Disturbi fis- sistema immuni
61 Cardiac disorders Uncommon Rare
Mhux komuni Rari
Common Uncommon
67 Disturbi gastro- intestinali Komuni Mhux komuni
Ascites, pancreatitis, dysphagia
Axxite, pankreatite, disfaġja
Skin and subcutaneous tissue disorders Uncommon Rare Unknown frequency
Disturbi fil- ġilda u fit- tessuti ta 'taħt il- ġilda Mhux komuni Rari
62 4.9 Overdose
4. 9 Doża eċċessiva
Treatment of pregabalin overdose should include general supportive measures and may include haemodialysis if necessary (see section 4.2 Table 1).
Il- kura ta 'doża eċċessiva ta' pregabalin għandha tinkludi miżuri ġenerali ta 'sostenn u tista' tinkludi ħemodijaliżi jekk ikun meħtieġ (ara sezzjoni 4. 2 Tabella 1).
63 Generalised Anxiety Disorder
Disturb ta 'Ansjetà Ġeneralizzata
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.
Fi provi kliniċi kkontrollati (li damu 4- 8 ġimgħat) 52% tal- pazjenti kkurati bi pregabalin u 38% tal - pazjenti fuq il- plaċebo kellhom titjib ta 'mill- anqas 50% fil- punteġġ totali tal- HAM- A mil- linja bażika sal- punt finali.
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.
69 Fi studji kontrollati, proporzjon ogħla ta ’ pazjenti trattati bi pregabalin rrappurtaw viżjoni mċajpra milli pazjenti trattati bi plaċebo, u li fil- biċċa l- kbira tal- każijiet irrisolva mat- tkomplija tad- dużaġġ.
64 Dosage adjustment in patients with reduced renal function or undergoing haemodialysis is necessary (see Section 4.2 Table 1).
Huwa meħtieġ aġġustament tad- doża f' pazjenti li għandhom funzjoni renali mnaqqsa jew li jkunu qegħdin jagħmlu ħemodijaliżi (ara Sezzjoni 4. 2 Tabella 1).
Linearity / non-linearity:
Lineari / mhux lineari:
Pharmacokinetics in special patient groups
70 Farmakokinetika fi gruppi speċjali ta 'pazjenti
In mice, no increased incidence of tumours was found at exposures
Fil- ġrieden, ma nstabet l- ebda inċidenza akbar ta 'tumuri f' esponimenti simili għall- esponiment medju tal- bniedem, iżda kienet osservata inċidenza akbar ta' haemangiosarcoma f' esponimenti aktar għoljin.
At therapeutic exposures, there was evidence of CNS clinical signs of hyperactivity and bruxism and some changes in growth (transient body weight gain suppression).
71 sinjali kliniċi tas- CNS ta 'attività eċċessiva u tgħażżiż tas- snien u xi bidliet fit- tkabbir (trażżiż temporanju taż- żieda fil- piż tal- ġisem).
66 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
LYRICA 225 mg hard capsules
LYRICA 225 mg kapsuli iebsin
Each hard capsule contains 225 mg of pregabalin.
Kull kapsula iebsa fiha 225 mg ta 'pregabalin.
Hard capsule White and light orange marked “Pfizer” on the cap and “PGN 225” on the body with black ink.
Kapsula iebsa Bajda u oranġjo ċar, immarkata “ Pfizer ” fuq il- parti ta 'fuq u “ PGN 225 ” fuq il- parti ewlenija b' linka sewda.
68 Generalised Anxiety Disorder
74 Disturb ta 'Ansjetà Ġeneralizzata
Table 1.
75 Tabella 1.
69 Use in children and adolescents
Użu fit- tfal u l- adoloxxenti
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.
Fi studji kontrollati, proporzjon ogħla ta ’ pazjenti ttrattati bi pregabalin irrappurtaw viżjoni mċajpra milli dawk ttrattati bi plaċebo, u fil- biċċa ‘ l kbira tal- pazjenti il- viżjoni iċċarat meta tkompla id - 76 dużaġġ.
In the clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the incidence of fundoscopic changes was greater in placebo-treated patients (See section 5.1)
Fl- istudji kliniċi fejn saru testijiet oftalmoloġiċi, l- inċidenza ta ’ tnaqqis ta ’ l- akuita ’ viżiva u bdil fil- kamp viżwali kienu aktar f’ pazjenti fuq kura bi preglabalin milli f’ pazjenti fuq plaċebo; l - inċidenza ta ’ bdil fundoskopiku kien ogħla minn f’ pazjenti ttrattati bi plaċebo (Ara sezzjoni 5. 1).
Pregabalin should be used with caution in these patients.
Fi provi fuq perijodu qasir ta 'pazjenti mingħajr mard tal- qalb jew vaskulari periferali klinikament sinifikanti, ma kien hemm l- ebda assoċjazzjoni evidenti bejn edema periferali u kardjovaskulari. kumplikazzjonijiet bħal pressjoni għolja jew insuffiċjenza tal- qalb konġestiva.
Discontinuation of pregabalin may resolve the reaction..
Peress li hemm informazzjoni limitata dwar pazjenti b' insuffiċjenza severa tal- qalb konġestiva, pregabalin għandu jintuża b' attenzjoni f' dawn il - pazjenti.
Pregabalin may potentiate the effects of ethanol and lorazepam.
77 Pregabalin jista ’ jżid l- effetti ta ’ ethanol u lorazepam.
In controlled clinical trials, multiple oral doses of pregabalin co- administered with oxycodone, lorazepam, or ethanol did not result in clinically important effects on respiration.
Fi studji kliniċi kkontrollati, dożi orali multipli ta 'pregabalin mogħtija flimkien ma' oxycodone, lorazepam, jew ethanol ma rriżultawx f' effetti klinikament importanti fuq ir- respirazzjoni..
71 reactions were dizziness and somnolence.
L- aktar reazzjonijiet avversi li ġew irrapportati b' mod komuni kienu sturdament u ngħas.
Body System Immune system disorders
78 Sistema tal- Ġisem Disturbi fis- sistema immuni
72 Cardiac disorders Uncommon Rare
Mhux komuni Rari
Common Uncommon
79 Disturbi gastro- intestinali Komuni Mhux komuni
Reproductive system and breast disorders Common Uncommon Rare
Disturbi fis- sistema riproduttiva u fis- sider Komuni Mhux komuni Rari
73 4.9 Overdose
4. 9 Doża eċċessiva
In controlled clinical trials in peripheral neuropathic pain 35% of the pregabalin treated patients and 18% of the patients on placebo had a 50% improvement in pain score.
Fi studji kliniċi kkontrollati dwar uġigħ nevrotiku periferali, 35% tal- pazjenti kkurati bi pregabalin u 18% tal- pazjenti fuq il- plaċebo kellhom titjib ta '50% fil- punteġġ ta' l- uġigħ.
74 Generalised Anxiety Disorder
Disturb ta 'Ansjetà Ġeneralizzata
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.
81 Fi studji kontrollati, proporzjon ogħla ta ’ pazjenti trattati bi pregabalin rrappurtaw viżjoni mċajpra milli pazjenti trattati bi plaċebo, u li fil- biċċa l- kbira tal- każijiet irrisolva mat- tkomplija tad- dużaġġ.