qanastek/EMEA-V3 huggingface dataset:
Do not shake.
Iċċaqlaqx bis- saħħa.
After the powder has dissolved (which usually occurs immediately), check that the resulting solution is clear and does not contain any particles.
Wara li t- trab inħall (li normalment tiġri immedjatament), ivverifika li t- taħlita likwida hi ċara u ma fihix frak.
Turn the vial upside down and gently draw the solution back into the syringe.
Aqleb il- kunjett rasu l- isfel u bil- mod iġbed it- taħlita likwida lura fis- siringa.
You may also mix Luveris and follitropin alfa as an alternative to injecting each product separately.
Tista ’ tħallat ukoll il- Luveris u l- follitropin alfa flimkien minflok ma tinjetta ż- żewġ prodotti seperatament.
After dissolving the Luveris powder, draw the solution back into the syringe and re-inject it into the container with the follitropin alfa powder.
Wara li jinħall it- trab tal- Luveris, iġbed it- taħlita lura fis- siringa u erġa ’ injettaha fil - kontenitur bit- trab tal- follitropin alfa.
Once the powder has dissolved, draw the solution back into the syringe.
Wara li jinħall it- trab, erġa ’ iġbed it- taħlita likwida fis- siringa.
• Change the needle for the fine-bore needle and remove any air bubbles:
• Ibdel il- labra għal- labra fina għat- titqib u neħħi xi bżieżaq ta ’ l- arja:
If you see air bubbles in the syringe, hold the syringe with the needle pointing upwards and gently flick the syringe until all the air collects at the top.
Jekk tara xi bżieżaq ta ’ l - arja fis- siringa, żomm is- siringa bil- labra tipponta ‘ l fuq u bil- mod ifflikkja s- siringa sakemm l- arja tinġabar fuq.
Gently push the plunger until the air bubbles are gone.
Bil - mod ibbotta l- istrument sakemm il- bżieżaq ta ’ l- arja jitilqu.
• Immediately inject the solution:
• Injetta t- taħlita likwida mill- ewwel:
Your doctor or nurse will have already advised you where to inject (e.g. tummy, front of thigh).
It- tabib jew l- infiermiera tiegħek se jkunu diġà avżawk fejn tinjetta (eż żaqq, naħa ta ’ quddiem tal- koxxa).
Wipe the chosen area with an alcohol swab.
Imsaħ il- parti magħżula b’ ċarruta mxarrba bl -
Firmly pinch the
27 alkoħol.
28 skin together and insert the needle at a 45° to 90° angle using a dart-like motion.
Agħfas sew il- ġilda u daħħal il- labra f’ anglu ta ’ 45° sa 90° isek qed twaddab dart.
Inject under the skin, as you were taught.
Injetta taħt il- ġilda, kif kont mgħallem.
Inject the solution by pushing gently on the plunger.
Injetta t - taħlita billi tibbota bil- mod il- planġer.
Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.
Neħħi l - labra mill- ewwel u naddaf il- ġilda b’ ċarruta ta ’ l- alkoħol b’ moviment ċirkulari.
Any unused solution must be discarded.
Kull taħlita likwida mhux użata għandha tintrema
The effects of an overdose of Luveris are unknown, nevertheless there is a possibility that ovarian hyperstimulation syndrome may occur, which is further described in ‘Possible side effects'.
L- effetti ta ’ doża żejda ta ’ Luveris mhumiex magħrufa, iżda teżisti l- possibilità li jirriżulta s- sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji, li hu deskritt f’ aktar dettall f’ Effetti oħra li jistgħu jinħassu ’.
However this will only occur if hCG is administered (see section headed ‘Take special care with Luveris’).
(ara s- sezzjoni bit- titlu ‘ Oqgħod attent ħafna bil- Luveris)
Like all medicines, Luveris can cause side effects, although not everybody gets them.
Bħall- mediċini l- oħra kollha, Luveris jista ’ jkollu effetti oħra, għalkemm ma jidhrux fuq kulħadd
Local reactions at the injection site (pain, redness, itching, swelling and bruising) have been observed in some cases.
Reazzjonijiet lokali fis- sit ta ’ l- injezzjoni (uġigħ, ħmur, tekil, infieħ u brix) kienu osservati f’ ċertu każi.
Treatment with FSH and LH followed by hCG can lead to a condition called ovarian hyperstimulation syndrome (OHSS) (see also section headed ‘Take Special Care with Luveris’).
Kura bl- FSH u l- LH segwita mill- hCG tista ’ twassal għall- kundizzjoni magħrufa bħala sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji.
This is when the ovaries over-react to the treatment, and large ovarian cysts develop.
(ara wkoll is- sezzjoni bl- isem ta ’ ‘ Oqgħod attent ħafna bil- Luveris ’).
First symptoms of OHSS are pain in the lower abdominal region, possibly in combination with nausea, vomiting and weight gain.
L- ewwel sintomi ta ’ l- OHSS huma l- uġigħ fir- reġjun addominali t’ isfel, possibilment flimkien ma ’ nawżea, vomtu u żieda fil- piż.
If you experience serious abdominal pain together with these symptoms, do not give any more injections, and speak to your doctor as soon as possible.
Jekk tesperjenza uġigħ addominali qawwi flimkien ma ’ dawn is- sintomi, tieħux aktar injezzjonijiet, u kellem lit- tabib tiegħek kemm jista ’ jkun malajr.
A careful examination will establish whether your ovaries have responded excessively to the treatment.
Eżaminazzjoni bir- reqqa tistabbilixxi jekk l- ovarji tiegħek irrispondewx b’ mod eċċessiv għat - trattament.
If so, your doctor may discontinue the FSH and LH, and abandon the treatment with hCG, to prevent the development of more severe OHSS.
Jekk iva, it- tabib jista ’ jwaqqaflek l- FSH u l- LH, u jabbandunalek it- trattament bl- hCG, biex jevita l- iżvilupp ta ’ OHSS aktar gravi.
Rarely abnormal blood clots in veins have been seen to occur with similar medicines, so this could possibly occur with Luveris / FSH / hCG therapy.
It- torsjoni ta ’ l- ovarji u d- demm fl- addome ma kienux irrapurtat bil- Luveris iżda kien hemm każi rappurtati wara t- trattament bil- gonadotrofina umana tal- menopawża (hMG), mediċina derivata mill - urina li fiha LH.
Torsion of the ovary and bleeding into the abdomen have not been reported with Luveris, however, there have been rare cases reported following treatment with human menopausal gonadotrophin (hMG), a urine-derived medication also containing LH.
Tqala ektopika (embriju impjantat barra il- ġuf) tista ’ tirriżulta speċjalment f’ nisa bi storja preċedenti ta ’ mard fit- tubi.
Ectopic pregnancy (embryo implanted outside the womb) may occur especially in women with a history of prior tubal disease.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex
29 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
28 imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek
Keep out of the reach and sight of children.
Żomm fejn ma ’ jintlaħaqx u ma jidhirx mit- tfal
The expiry date refers to the last day of that month.
Din id- Data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar.
Do not use Luveris if you notice any visible signs of deterioration, such as discolouration of the powder or damage to the container.
Tużaħx jekk tara xi sinjali viżibbli ta ’ deterjorazzjoni, bħal meta t- trab jitlef il- kulur jew hemm ħsara lil- kontenitur.
- The active substance is lutropin alfa 75 IU (International Units).
- Is- sustanza attiva hi lutropin alfa 75 IU.
- The other ingredients are polysorbate 20, sucrose, sodium dihydrogen phosphate monohydrate,
- Is- sustanzi l- oħra huma polisorbat 20, sukrożju, fosfat mono- idrat tas- sodju di- idroġinat, fosfat
disodium phosphate dihydrate, concentrated phosphoric acid, sodium hydroxide, methionine and nitrogen.
di- idrat tad- di- sodju, aċidu fosforiku konċentrat, idrossidu tas- sodju, metjonina u nitroġenu
What Luveris looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
It is supplied in packs containing 1, 3 or 10 vials of powder, together with the same number of solvent vials.
Il- prodott jiġi f’ pakketti ta ’ 1, 3 jew 10 kunjetti bl- istess ammont ta ’ kunjetti bis- solvent
Each vial of powder contains 75 IU of lutropin alfa and each vial of solvent contains 1 ml of water for injection.
Kull kunjett ta ’ trab fiha 75 IU ta ’ lutropin alfa u kull kunjett ta ’ solvent fiha 1ml ta ’ ilma għall - injezzjoni
30 België/Belgique/Belgien MERCK NV/SA Brusselsesteenweg 288 B-3090 Overijse Tél/Tel: +32-2-686 07 11
29 Luxembourg/ Luxemburg België/ Belgique/ Belgien MERCK NV/ SA MERCK NV/ SA Brusselsesteenweg 288 Brusselsesteenweg 288 B- 3090 Overijse, Belgique/ Belgien B- 3090 Overijse Tél/ Tel: +32- 2- 686 07 11 Tél/ Tel: +32- 2- 686 07 11
31 España Merck S.L.
30 Portugal España Merck, s. a.
Strength 25 mg 25 mg 25 mg 25 mg 25 mg
Lyrica 25 mg Lyrica 25 mg Lyrica 25 mg Lyrica 25 mg Lyrica 25 mg
Pharmaceutical Form Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa
Route of Administration Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali
Packaging blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) perforated unit dose blister (PVC/ alu)
folja (PVC/ alu) folja (PVC/ alu) folja (PVC/ alu) folja (PVC/ alu) folji ta ’ doża waħda perforat (PVC/ alu)
50 mg 50 mg 50 mg 50 mg 50 mg
Lyrica 50 mg Lyrica 50 mg Lyrica 50 mg Lyrica 50 mg Lyrica 50 mg
Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa
blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) perforated unit dose blister (PVC/ alu)
folja (PVC/ alu) folja (PVC/ alu) folja (PVC/ alu) folja (PVC/ alu) folji ta ’ doża waħda perforat (PVC/ alu)
75 mg 75 mg 75 mg
Lyrica 75 mg Lyrica 75 mg Lyrica 75 mg
Capsule, hard Capsule, hard Capsule, hard
Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa
blister (PVC/ alu) blister (PVC/ alu) perforated unit dose blister (PVC/ alu)
folja (PVC/ alu) folja (PVC/ alu) folji ta ’ doża waħda perforat (PVC/ alu)
100 mg 100 mg 100 mg
Lyrica 100 mg Lyrica 100 mg Lyrica 100 mg
150 mg 150 mg 150 mg
Lyrica 150 mg Lyrica 150 mg Lyrica 150 mg
200 mg 200 mg 200 mg
Lyrica 200 mg Lyrica 200 mg Lyrica 200 mg
300 mg 300 mg 300 mg
Lyrica 300 mg Lyrica 300 mg Lyrica 300 mg
Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
blister (PVC/ alu) blister (PVC/ alu) bottle (HDPE) bottle (HDPE) bottle (HDPE) blister (PVC/ alu) blister (PVC/ alu) perforated unit dose blister (PVC/ alu)
folja (PVC/ alu) folja (PVC/ alu) folja (PVC/ alu) folja (PVC/ alu) flixkun (HDPE) flixkun (HDPE) flixkun (HDPE) folja (PVC/ alu) folja (PVC/ alu) folji ta ’ doża waħda perforat (PVC/ alu)
EU/ 1/ 04/ 279/ 041
EU/ 1/ 04/ 279/ 036 EU/ 1/ 04/ 279/ 037 EU/ 1/ 04/ 279/ 038 EU/ 1/ 04/ 279/ 039 EU/ 1/ 04/ 279/ 040 EU/ 1/ 04/ 279/ 041 EU/ 1/ 04/ 279/ 042 EU/ 1/ 04/ 279/ 043
Capsule, hard
Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa
blister (PVC/ alu) non perforated
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
blister (PVC/ alu) non perforated
folja (PVC/ alu) mhux perforata folja (PVC/ alu) mhux perforata folja (PVC/ alu) mhux perforata folja (PVC/ alu) mhux perforata folja (PVC/ alu) mhux perforata folja (PVC/ alu) mhux perforata folja (PVC/ alu) mhux perforata folja (PVC/ alu) mhux perforata
LYRICA 25 mg hard capsules
LYRICA 25 mg kapsuli iebsin
Each hard capsule contains 25 mg of pregabalin.
Kull kapsula iebsa fiha 25 mg ta 'pregabalin.
Lyrica capsules also contain lactose monohydrate.
Il- kapsuli Lyrica fihom ukoll lactose monohydrate.
Hard capsule White, marked “ Pfizer ” on the cap and “ PGN 25 ” on the body with black ink.
Kapsula iebsa Bajda, immarkata “ Pfizer ” fuq il- parti ta 'fuq u “ PGN 25 ” fuq il- parti ewlenija b' linka sewda.
Neuropathic pain
Uġigħ nevrotiku
Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.
Lyrica huwa indikat għall- kura ta 'uġigħ periferali u ċentrali f' persuni adulti.
Epilepsy
Epilessija
Lyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Lyrica huwa indikat bħala terapija aġġuntiva f' persuni adulti li jbatu minn aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja.
Generalised Anxiety Disorder
Disturb ta 'Ansjetà Ġeneralizzata
LYRICA is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
LYRICA huwa indikat għall- kura tad- Disturb ta 'Ansjetà Ġeneralizzata (GAD - Generalised Anxiety Disorder) f' persuni adulti.
The dose range is 150 to 600 mg per day given in either two or three divided doses.
Il- medda tad- doża hi 150 sa 600 mg kuljum mogħtija f' żewġ jew tliet dożi maqsuma.
Lyrica may be taken with or without food.
Lyrica jista 'jittieħed ma' l- ikel jew waħdu.
Pregabalin treatment can be started at a dose of 150 mg per day.
Il- kura bi pregabalin tista 'tinbeda b' doża ta' 150 mg kuljum.
Based on individual patient response and tolerability, the dosage may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.
Fuq il- bażi tar- rispons u t- tolleranza tal - pazjent individwali, id- doża tista 'tiżdied għal 300 mg kuljum wara intervall ta' 3 sa 7 ijiem, u jekk ikun meħtieġ, għal doża massima ta '600 mg kuljum wara intervall ieħor ta' 7 ijiem.
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.
Based on individual patient response and tolerability, the dosage may be increased to 300 mg per day after 1 week.
Fuq il- bażi tar- rispons u t- tolleranza tal - pazjent individwali, id- doża tista 'tiżdied għal 300 mg kuljum wara ġimgħa.
The maximum dosage of 600 mg per day may be achieved after an additional week.
Id- doża massima ta '600 mg kuljum tista' tinkiseb wara ġimgħa addizzjonali.
2 Generalised Anxiety Disorder
2 Disturb ta 'Ansjetà Ġeneralizzata
The dose range is 150 to 600 mg per day given as two or three divided doses.
L- ammont ta 'doża li jista' jittieħed hu bejn 150 u 600 mg kuljum imqassmin f' żewġ dożi jew tlieta.
The need for treatment should be reassessed regularly.
Il - ħtieġa tal- kura għandha tiġi vvalutata mill- ġdid b' mod regolari.
Following an additional week the dosage may be increased to 450 mg per day.
Wara ġimgħa addizzjonali d- doża tista 'tiżdied għal 450 mg kuljum.
Discontinuation of pregabalin
Twaqqif ta 'pregabalin
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 jitwaqqaf, huwa rakkomandat li dan isir fuq perijodu minimu ta' ġimgħa indipendentement mill- indikazzjoni (ara sezzjoni 4. 8).
Patients with renal impairment
Pazjenti b' indeboliment tal- kliewi
Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug.
Pregabalin jiġi eliminat miċ- ċirkolazzjoni sistemika prinċipalment permezz ta 'tneħħija renali bħala mediċina mhux mibdula.
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) ⎤ ⎥ (x 0. 85 for female patients) CLcr( ml/ min) = ⎢ ⎥
⎥ (x 0.85 for female patients)
serum creatinine (μmol/ l)
serum creatinine (μmol/l)
age (years) weight (kg) serum creatinine for female patients
⎥ ⎦
Pregabilin jitneħħa b' mod pazjenti li jkunu qegħdin
Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours).
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 'jirċievu ħemodijaliżi, id- doża tal- ġurnata ta' pregabalin għandha tiġi
In addition to the daily dose, a supplementary dose should be given immediately following every 4- hour haemodialysis treatment (see Table 1).
Minbarra d- doża ta 'kuljum, għandha tingħata doża supplimentari immedjatament wara kull trattament ta' 4 sigħat b' ħemodijaliżi (ara Tabella 1).
Table 1.
3 Tabella 1.
Pregabalin dosage adjustment based on renal function
Aġġustament fid- doża ta 'pregabilin fuq il- bażi tal- funzjoni tal- kliewi
Creatinine
(CLcr) (mL/ min)
Clearance (CLcr) (mL/min)
Doża Totali ta '
Total Pregabalin Daily dose *
Pregabilin Kuljum *
Dose Regimen
Reġim tad- Doża
Starting dose (mg/day)
Doża inizjali (mg/ ġurnata)
Maximum dose (mg/day)
Doża massima (mg/ ġurnata)
BID or TID BID or TID Once Daily or BID Once Daily
Darba Kuljum
Supplementary dosage following haemodialysis (mg)
Doża supplimentari wara ħemodijaliżi (mg) Doża waħda+
TID = Three divided doses BID = Two divided doses
TID = Tliet dożi maqsumin BID = Żewġ dożi maqsumin
* Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose + Supplementary dose is a single additional dose
* Id- doża totali tal- ġurnata (mg/ ġurnata) għandha tiġi maqsuma kif indikat mir- reġim tad- doża biex tipprovdi mg/ doża + Doża supplimentari hija doża waħda addizzjonali
3 Use in patients with hepatic impairment
Użu f' pazjenti b' indeboliment tal- fwied
No dosage adjustment is required for patients with hepatic impairment (see section 5.2).
Mhux meħtieġ aġġustament fid- doża għal pazjenti b' indeboliment tal- fwied (ara sezzjoni 5. 2).
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).
Use in the elderly (over 65 years of age)
Użu fl- anzjani ('il fuq minn 65 sena)
Elderly patients may require a dose reduction of pregabalin due to a decreased renal function (see patients with renal impairment).
Jista 'jkun li pazjenti anzjani jkunu jeħtieġu tnaqqis fid- doża ta' pregabalin minħabba funzjoni mnaqqsa tal- kliewi (ara pazjenti b' indeboliment tal- kliewi).
In accordance with current clinical practice, some diabetic patients who gain weight on pregabalin treatment may need to adjust hypoglycaemic medications.
Konformi ma 'prattika klinika kurrenti, xi pazjenti dijabetiċi li jżidu fil- piż waqt kura bi pregabalin jistgħu jkollhom bżonn jaġġustaw il- medikazzjonijiet ipoglemiċi.
There have been reports in the postmarketing experience of hypersensitivity reactions, including cases of angioedema.
Kienu hemm rapporti ta ’ reazzjonijiet ta ’ sensittività eċċessiva fl- esperjenza ta ’ wara t- tqegħid fis- suq, inklużi każijiet ta ’ anġoedema.
Pregabalin should be discontinued immediately if symptoms of angioedema, such as facial, perioral, or upper airway swelling occur.
Pregabalin għandu jkun mwaqqaf immedjatament jekk sintomi ta ’ anġoedema, bħal nefħa fil- wiċċ jew fil- parti ta ’ fuq tas- sistema respiratorja jiġru.
Pregabalin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in the elderly population.
Il- kura bi pregabalin ġiet assoċjata ma 'sturdament u ngħas, li jistgħu jżidu l- okkorrenza ta' korriment aċċidentali (waqgħat) fil- popolazzjoni anzjana.
There have also been post marketing reports of loss of consciousness, confusion and mental impairment.
Kien hemm ukoll rapporti ta ’ wara t- tqegħid fis- suq ta ’ ħass ħażin, konfużjoni u indeboliment mentali.
Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medication.
Għalhekk, il- pazjenti għandhom jingħataw il- parir biex joqogħdu attenti sakemm ikunu familjari ma 'l- effetti potenzjali tal- medikazzjoni.
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 - 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 4 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 ieħor fl- akuita ’ viżiiva.
Discontinuation of pregabalin may result in resolution or improvement of these visual symptoms.
Twaqqif ta ’ pregabalin jista jirriżulta f’ risoluzzjoni jew ameljorament ta ’ dawn is- sintomi viżivi
Cases of renal failure have been reported and discontinuation of pregabalin did show reversibility of this adverse effect.
Każijiet ta ’ insuffiċjenza renali ġew irrappurtati u s- sospensjoni ta ’ pregabalin, wera riversibilita ’ ta ’ dan l- effett avvers.
There are insufficient data for the withdrawal of concomitant antiepileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached, in order to reach monotherapy on pregabalin.
M' hemmx informazzjoni biżżejjed dwar it- twaqqif ta 'prodotti mediċinali konkomitanti kontra l - epilessija, ladarba jkun inkiseb kontroll ta' l- aċċessjonijiet bi pregabalin fis- sitwazzjoni add- on, bil - għan li tintlaħaq terapija waħdanija bi pregabalin.
After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms have been observed in some patients.
Wara li twaqqfet il- kura fuq perijodu qasir u fuq perijodu twil bi pregabalin kienu osservati sintomi ta 'l- irtirar tal- mediċina f' ċerti pazjenti.
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.
The patient should be informed about this at the start of the treatment.
Il - pazjent għandu jiġi infurmat dwar dan fil- bidu tal- kura.
4 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.
Pregabalin għandu jintuża b’ attenzjoni f’ dawn il- pazjenti.
Pregabalin should be used with caution in these patients.
Twaqqif ta ’ pregabalin jista jfejjaq ir- reazzjoni.
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.
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.
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.
This may be attributed to an additive effect due to concomitant medication (e.g. anti-spasticity agents) needed for this condition.
Dan jista 'jkun attribwit għal effett addittiv minħabba medikazzjoni konkomitanti (p. e. aġenti kontra l- ispastiċità) meħtieġa għal din il- kondizzjoni.
This should be considered when prescribing pregabalin in this condition.
Dan għandu jkun ikkunsidrat meta jiġi ordnat pregabalin f' din il- kondizzjoni.
Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (< 2% of a dose recovered in urine as metabolites), does not inhibit drug metabolism in vitro, and is not bound to plasma proteins, it is unlikely to produce, or be subject to, pharmacokinetic interactions.
Billi pregabalin jitneħħa fil- parti l- kbira mhux mibdul fl- awrina, jgħaddi minn metaboliżmu negliġibbli fin- nies (< 2% ta 'doża tkun irkuprata fl- awrina bħala metaboliti), ma jostakolax il - metaboliżmu tal- mediċina in vitro, u ma jeħilx mal- proteini tal- plasma, mhux probabbli li jipproduċi, jew ikun suġġett għal, interazzjonijiet farmakokinetiċi.
Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol.
F' dan ir- rigward, fi studji in vivo ma kienu osservati ebda interazzjonijiet farmakokinetiċi klinikament rilevanti bejn pregabalin u phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone jew ethanol.
Population pharmacokinetic analysis indicated that oral antidiabetics, diuretics, insulin, phenobarbital, tiagabine and topiramate had no clinically significant effect on pregabalin clearance.
Analiżi farmakokinetika tal- popolazzjoni indikat li s- sustanzi orali kontra d- dijabete, id- dijuretiċi, l- insulina, phenobarbital, tiagabine u topiramate ma kellhom l - ebda effett klinikament sinifikanti fuq it- tneħħija ta 'pregabalin.
Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyl oestradiol does not influence the steady-state pharmacokinetics of either substance.
L- amministrazzjoni ta 'pregabalin mal- kontraċettivi orali norethisterone u/ jew ethinyl oestradiol ma tinfluwenzax il- farmakokinetika stabbli ta' xi waħda mis- sustanzi.
Pregabalin may potentiate the effects of ethanol and lorazepam.
5 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 dipressanti tas- CNS.
Pregabalin appears to be additive in the impairment of cognitive and gross motor function caused by oxycodone.
Pregabalin jidher li hu addittiv fl- indeboliment tal- funzjoni konoxxittiva u motorja globali kkawżat minn oxycodone.
No specific pharmacodynamic interaction studies were conducted in elderly volunteers.
Ma sarux studji speċifiċi dwar l- interazzjoni farmakodinamika f' voluntiera anzjani.
Interaction 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.
There are no adequate data from the use of pregabalin in pregnant women.
M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ pregabalin waqt it- tqala.
Studies in animals have shown reproductive toxicity (see 5.3).
Studji fuq bhejjem urew ħsara fuq is- sistema riproduttiva (ara 5. 3).
Lyrica should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Lyrica m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar (jekk il- vantaġġ għall- omm jisboq b' mod ċar ir- riskju potenzjali għall- fetu).
Effective contraception must be used in women of child bearing potential.
Għandha tintuża kontraċezzjoni effettiva f' nisa li jistgħu jinqabdu tqal.
It is not known if pregabalin is excreted in the breast milk of humans; however, it is present in the milk of rats.
Mhux magħruf jekk pregabalin jitneħħiex fil- ħalib tas- sider uman; madankollu, huwa preżenti fil- ħalib tal- firien.
Therefore, breast-feeding is not recommended during treatment with pregabalin.
Għalhekk, mhux rakkomandat treddigħ waqt kura bi pregabalin.
Lyrica may have minor or moderate influence on the ability to drive and use machines.
Lyrica jista 'jkollu effett żgħir jew moderat fuq il- ħila ta' sewqan u l- użu ta 'magni.
Lyrica may cause dizziness and somnolence and therefore may influence the ability to drive or use machines.
Lyrica jista 'jikkawża sturdament u ngħas u għalhekk jista' jaffettwa l- ħila biex issuq jew tħaddem magni.
Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medication affects their ability to perform these activities.
Il - pazjenti huma mogħtija parir biex ma jsuqux, ma jħaddmux makkinarju kumpless u ma jinvolvux ruħhom f' attivitajiet oħra li jistgħu jkunu perikolużi sakemm ikun magħruf jekk din il- medikazzjoni taffettwax il- ħila tagħhom biex iwettqu dawn l- attivitajiet.
The pregabalin clinical programme involved over 9000 patients who were exposed to pregabalin, of whom over 5000 were in double-blind placebo controlled trials.
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.
The most commonly reported adverse reactions were dizziness and somnolence.
L- aktar reazzjonijiet avversi li ġew irrapportati b' mod komuni kienu sturdament u ngħas.
Adverse reactions were usually mild to moderate in intensity.
Ġeneralment ir - reazzjonijiet avversi kienu ta 'severità ħafifa għal moderata.
In all controlled studies, the discontinuation rate due to adverse reactions was 13% for 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.
The most common adverse 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.
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)).
Fit- tabella ta 'hawn isfel ir- reazzjonijiet avversi kollha, li seħħew b' inċidenza akbar mill- plaċebo u f' aktar minn pazjent wieħed, huma elenkati bil- klassi u l- frekwenza (komuni ħafna (> 1/ 10), komuni (> 1/ 100, < 1/ 10), mhux komuni (> 1/ 1000, < 1/ 100) u rari (< 1/ 1000)).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F' kull sezzjoni ta 'frekwenza, l - effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom.
The adverse reactions listed may also be associated with the underlying disease and / or concomitant medications.
Ir- reazzjonijiet avversi elenkati jistgħu jkunu assoċjati wkoll mal- marda prinċipali u/ jew medikazzjonijiet konkomitanti.
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).
Fil- kura ta 'uġigħ nevrotiku ċentrali minħabba leżjoni fil- korda spinali, l- inċidenza ta' episodji avversi b' mod ġenerali, episodji avversi ta 'CNS u b' mod speċjali tan- ngħas żdiedet (Ara 4. 4).
Additional reactions reported from post-marketing experience are included as Unknown frequency in italics in the list below.
Reazzjonijiet oħra rrapportati mill- esperjenza wara t- tqegħid fis- suq huma inklużi bħala Frekwenza mhux magħrufa miktubin korsiv fil- lista ta 'hawn isfel.
Body System Immune system disorders
6 Sistema tal- Ġisem Disturbi fis- sistema immuni
Adverse drug reactions
Reazzjonijiet avversi għall- mediċina
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
Appetite increased Anorexia Hypoglycaemia
Żieda fl- aptit Anoressija Ipogliċemija
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
Burdata ewforika, konfużjoni, irritabilità, tnaqqis fil- libido Alluċinazzjoni, attakk ta 'paniku, irrekwitezza, aġitazzjoni, depressjoni, burdata depressa, bidliet fil- burdata, spersonalizzazzjoni, aggravament tan- nuqqas ta' rqad, diffikulta 'biex issib il- kelma, ħolm anormali, żieda fil- libido, inkapaċità li tilħaq orgażmu, apatija
Rare Nervous system disorders
Rari Disturbi fis- sistema nervuża
Disinhibition, elevated mood
Tneħħija ta 'l- inibizzjoni, burdata għolja
Very Common Common
Komuni ħafna Komuni
Dizziness, somnolence Ataxia, coordination abnormal, tremor, dysarthria, memory impairment, disturbance in attention, paraesthesia
Sturdament, ngħas Atassja, koordinazzjoni mhux normali, tregħid, dysarthria, indeboliment tal- memorja, disturb fl- attenzjoni, parasteżija
Syncope, stupor, myoclonus, psychomotor hyperactivity, ageusia, dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive disorder, speech disorder, hyporeflexia, hypoaesthesia, amnesia, hyperaesthesia, burning sensation
Sinkope, sturdament, myoclonus, attività psikomotorili eċċessiva, telf tat- togħma, dyskinesia, sturdament tal- posizzjoni, tregħid waqt moviment volontarju, nystagmus, disturb konoxxittiv, disturb fid - diskors, nuqqas ta 'riflessi, ipoestesija, amnesija, iperestesija, sensazzjoni ta' ħruq
Rare Unknown frequency
Rari
Eye disorders
Ipokinesja, parosmia, disgrafija
Common Uncommon
Frekwenza mhux magħrufa Ħass ħażin, indeboliment mentali, uġigħ ta 'ras Disturbi fl- għajnejn Komuni Mhux komuni
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 viżwali, akutezza viżwali mnaqqsa, uġigħ fl- għajnejn, astenopja, għajnejn xotti, tidmigħ aktar
Peripheral vision loss, oscillopsia, altered visual depth perception, photopsia, eye irritation, mydriasis, strabismus, visual brightness
Telf tal- vista periferali, oscillopsia, perċezzjoni mibdula tal- fond viżwali, fotopsja, irritazzjoni fl- għajnejn, mydriasis, strabismus, luminożità viżwali
Unknown frequency Ear and labyrinth disorders
Frekwenza mhux magħrufa Keratite Disturbi fil- widnejn u fis- sistema labirintika Komuni Rari Disturbi fil- qalb
Uncommon Rare
Mhux komuni Rari
Tachycardia Atrioventricular block first degree, sinus tachycardia, sinus bradycardia, sinus arrhythmia
Takikardija Imblokk atrijoventrikolari ta 'l- ewwel grad, sinus tachycardia, sinus bradycardia, sinus arrhythmia
Unknown frequency Vascular disorders
Frekwenza mhux magħrufa Insuffiċjenza tal- qalb konġestiva Disturbi vaskulari Mhux komuni Rari
Flushing, hot flushes Hypotension, hypertension, peripheral coldness
Fwawar, fwawar tal- menopawsa Pressjoni baxxa, pressjoni għolja, kesħa periferali
Respiratory, thoracic and mediastinal disorders Uncommon Rare Gastrointestinal disorders
Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni Rari
Dyspnoea, nasal dryness Epistaxis, throat tightness, nasopharyngitis, cough, nasal congestion, rhinitis, snoring
Dispnea, nixfa nażali Epistassi, għeluq tal- gerżuma, rinofarinġite, sogħla, konġestjoni nażali, rinite, nħir
Common Uncommon
7 Disturbi gastro- intestinali Komuni Mhux komuni
Vomiting, dry mouth, constipation, flatulence Abdominal distension, gastrooesophageal reflux disease, salivary hypersecretion, hypoaesthesia oral
Rimettar, ħalq xott, stitikezza, gass fl- istonku Distensjoni addominali, mard tar- rifluss gastroesofagali, sekrezzjoni eċċessiva tas- saliva, ipoestesija orali
Ascites, pancreatitis, dysphagia Swollen tongue, diarrhoea, nausea
Axxite, pankreatite, disfaġja
Skin and subcutaneous tissue disorders Uncommon Rare Unknown frequency
Frekwenza mhux magħrufa Ilsien minfuħ, dijarea, dardir Disturbi fil- ġilda u fit- tessuti ta 'taħt il- ġilda Mhux komuni Rari
Rash papular, sweating Urticaria, cold sweat Stevens Johnson syndrome,Pruritus
Raxx bl- infafet, tagħriq Urtikarja, għaraq kiesaħ
Musculoskeletal and connective tissue disorders Uncommon
Frekwenza mhux magħrufa Sindrome Stevens Johnson, Ħakk Disturbi muskolu- skeltrali u tal- connective tissue Mhux komuni
Muscle twitching, joint swelling, muscle cramp, myalgia, arthralgia, back pain, pain in limb, muscle stiffness
Kontrazzjonijiet tal- muskoli, nefħa tal- ġogi, bugħawwieġ, uġigħ fil - muskoli, artralġja, uġigħ fid- dahar, uġigħ fil- membri, ebusija tal - muskoli
Rare Renal and urinary disorders
Rari
Rhabdomyolysis, cervical spasm, neck pain
Rhabdomyolysis, spażmu ċervikali, uġigħ fl- għonq
Uncommon Rare Unknown frequency
Disturbi fil- kliewi u fis- sistema urinarja Mhux komuni Rari
Urinary incontinence, dysuria Renal failure, oliguria Urinary retention
Inkontinenza ta 'l- awrina, disurja Insuffiċjenza tal- kliewi, oliguria
Reproductive system and breast disorders Common Uncommon Rare
Frekwenza mhux magħrufa Ritenzjoni urinarja Disturbi fis- sistema riproduttiva u fis- sider Komuni Mhux komuni Rari
Erectile dysfunction Ejaculation delayed, sexual dysfunction Amenorrhoea, breast discharge, breast pain, dysmenorrhoea, hypertrophy breast
Disfunzjoni ta 'l- erezzjoni Dewmien fl- ejakulazzjoni, disfunzjoni ta' natura sesswali Amenorreja, tnixxija mis- sider, uġigħ fis- sider, diżmenorreja, ipertrofija tas- sider
General disorders and administration site conditions Common Uncommon Rare Unknown frequency Investigations
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata 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
Common Uncommon
Mhux komuni Rari
Weight increased Blood creatine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, platelet count decreased
Żieda fil- piż Żieda fil- kreatina phosphokinase fid- demm, żieda fl- alanine aminotransferase, żieda fl- aminotransferase, tnaqqis fl- għadd ta 'pjastrini
Blood glucose increased, blood potassium decreased, white blood cell count decreased, blood creatinine increased, weight decreased
Żieda fil- glukosju fid- demm, tnaqqis fil- potassju fid- demm, tnaqqis fl- għadd ta 'ċelloli bojod tad- demm, żieda fil- kreatinina fid- demm, tnaqqis fil- piż
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.
In overdoses up to 15 g, no unexpected adverse reactions were reported.
Ma ġew irrapportati l- ebda reazzjonijiet avversi mhux mistennija meta ttieħdu dożi eċċessivi sa 15 g.
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.
F ’ esperjenza ta ’ wara t- tqegħid fis- suq, l- aktar reazzjonijiet avversi li ġew rappurtati meta ttieħdet doża eċċessiva ta ’ pregabalin kienu jinkludu, ngħas, stat ta ’ konfużjoni,, aġitazzjoni, u nuqqas ta ’ kwiet.
Treatment of pregabalin overdose should include general supportive measures and may include haemodialysis if necessary (see section 4.2 Table 1).
8 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).
Antiepileptics, ATC code:
Kura kontra l- epilessija, Kodiċi ATC:
The active substance, pregabalin, is a gamma-aminobutyric acid analogue ((S)-3-(aminomethyl)-5- methylhexanoic acid).
Is- sustanza attiva, pregabalin, hija gamma- aminobutyric acid analogue ((S) - 3 - (aminomethyl0- 5 - methylhexanoic acid).
Mechanism of action
Mekkaniżmu ta 'azzjoni
Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system, potently displacing [3H]-gabapentin.
Pregabalin jeħel ma 'subunit awżiljarju (α2- δproteini) ta' kanali tal- kalċju kkontrollati b' vultaġġ fis - sistema nervuża ċentrali, biex jieħu l- post bis- saħħa ta '[3H] - gabapentin.
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.
Efficacy has not been studied in other models of neuropathic pain.
L- effikaċja f' mudelli oħra ta 'uġigħ nevrotiku ma ġietx studjata.
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.
Pregabalin ġie studjat f' 10 studji kliniċi kkontrollati li damu sa 13- il ġimgħa fejn ingħatat doża darbtejn kuljum (BID) u sa 8 ġimgħat fejn ingħataw dożi tliet darbiet kuljum (TID).
Overall, the safety and efficacy profiles for BID and TID dosing regimens were similar.
B' mod ġenerali, il- profili tas- sigurtà u ta 'l- effikaċja għar- reġimi ta' dożaġġ BID u TID kienu simili.
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.
F' 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.
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 provi 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.
For patients not experiencing somnolence, such an improvement was observed in 33% of patients treated with pregabalin and 1 8% 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.
For patients who experienced somnolence the responder rates were 48% on pregabalin and 16% on placebo.
Fil- każ tal- pazjenti li esperjenzaw ngħas ir- rati tar- rispons kienu 48% fuq pregabalin u 16% fuq il- plaċebo.
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.
Fil- prova klinika kkontrollata dwar uġigħ nevrotiku ċentrali, 22% tal- pazjenti kkurati bi Pregabalin u 17% tal- pazjenti fuq il- plaċebo kellhom titjib ta '50% fil- punteġġ ta' l- uġigħ.
8 Epilepsy
Epilessija
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.
Pregabalin ġie studjat fi 3 studji kliniċi kkontrollati li damu 12- il ġimgħa fejn ingħataw dożi darbtejn kuljum (BID) jew tliet darbiet kuljum (TID).
A reduction in seizure frequency was observed by Week 1.
Kien osservat tnaqqis fil- frekwenza ta 'l- aċċessjonijiet ma' l- Ewwel Ġimgħa.
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.
Pregabalin ġie studjat f' 6 studji kkontrollati li damu 4- 6 ġimgħat, studju fost l- anzjani li dam 8 ġimgħat u studju fuq perijodu fit- tul dwar il- prevenzjoni tal- ħruġ mill- ġdid tal- marda b' fażi double blind ta 'prevenzjoni tal- ħruġ mill- ġdid tal- marda li damet 6 xhur.
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.
9 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.
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.
Ophthalmologic testing (including visual acuity testing, formal visual field testing and dilated funduscopic examination) was conducted in over 3600 patients within controlled clinical trials.
Testijiet oftalmoloġiċi (inklużi testijiet fuq akutezza viżiva, ittestjar formali tal- kamp viżiv u eżaminazzjoni ta ’ dilatar funduskopiku) sar fi 3600 pazjent fi studji kliniċi kontrollati.
In these patients, visual acuity was reduced in 6.5% of patients treated with pregabalin, and 4.8% of placebo-treated patients.
F’ dawn il - pazjenti, l- akutezza viżiva kienet imnaqqsa fi 6. 5% ta ’ pazjenti ttrattati bi pregabalin, u fi 4. 8% ta ’ pazjenti ttratati bil- plaċebo.
Visual field changes were detected in 12.4% of pregabalin-treated, and 11.7% of placebo-treated patients.
Bdil fil- kamp viżiv kien innutat fi 12. 4% ta ’ dawk trattati bi pregabalin, u 11. 7% ta ’ pazjenti fuq plaċebo.