natgillin/translations-raw huggingface dataset:
• Wash your hands.
• Zberite vse, kar potrebujete.
It is important that your hands and the items you use be as clean as possible.
Poiščite čisto površino in vse razpostavite:
• Assemble everything you need.
- eno vialo Luverisa,
Find a clean area and lay out everything:
- dve alkoholni blazinici,
one vial of Luveris, one vial of solvent, two alcohol swabs, one syringe, one reconstitution needle for dissolving the powder in the solvent, a fine-bore needle for subcutaneous injection, a sharps container for safe disposal of glass and needles.
- eno iglo za rekonstitucijo za raztopljanje praška v vehiklu,
Attach the reconstitution needle to the syringe and draw up some air into the syringe by pulling the plunger to approximately the 1 ml mark.
Pritrdite iglo za rekonstituiranje na brizgo in potegnite vanjo nekaj zraka, tako da potisnete bat približno do oznake 1 ml.
Remove the protective cap from the Luveris powder vial, pick up your syringe and slowly inject the solvent into the vial of Luveris.
vzemite brizgo in počasi injicirajte vehikel v vialo z Luveris praškom.
After the powder has dissolved (which usually occurs immediately), check that the resulting solution is clear and does not contain any particles.
• Ko se prašek raztopi (kar se občajno zgodi takoj), se prepričajte, da je nastala raztopina bistra in ne vsebuje delcev.
Inspect for particles as before, and do not use if the solution is not clear.
Enako kot prej, raztopino preglejte na prisotnost delcev in je ne uporaite, če ni bistra.
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.
• Zamenjajte iglo za rekonstitucijo s fino iglo za injiciranje in odstranite morebitne zračne mehurčke: če vidite mehurčke zraka v brizgi, jo držite tako, da igla gleda navzgor in nežno krcajte brizgo, da se ves zrak zbere na vrhu.
• Immediately inject the solution:
• Takoj si vbrizgajte raztopino:
Your doctor or nurse will have already advised you where to inject (e.g. tummy, front of thigh).
Vaš zdravnik ali sestra sta vas že poučila kje dati injekcijo (n. pr. v trebuh, sprednjo stran stegna).
Firmly pinch the
Trdno stistnite
28 skin together and insert the needle at a 45° to 90° angle using a dart-like motion.
28 kožo in z gibom, podobnim metu sulice, zabodite iglo pod kotom 45° do 90°.
However this will only occur if hCG is administered (see section headed ‘Take special care with Luveris’).
Vendar pa se le ta pojavi samo, če se daje hCG (glejte poglavje z naslovom ‘ Bodite posebno pozorni pri uporabi Luverisa ”).
Do not take a double dose to make up for a forgotten doses.
Ne vzemite dvojnega, če ste pozabili vzeti prejšnji odmerek.
The most frequent adverse events reported have been headache, abdominal pain, breast pain, nausea, somnolence (sleepiness) and ovarian cysts.
Najbolj pogosti neželeni dogodki o katerih so poročali, so glavobol, bolečine v trebuhu, bolečine v prsih, slabost, somnolenca (zaspanost) in ovarijske ciste.
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.
Če bi začutili močno bolečino v trebuhu, v povezavi z zgoraj naštetimi znaki, si popolnoma prenehajte dajati injekcije in takoj obiščite zdravnika.
Ectopic pregnancy (embryo implanted outside the womb) may occur especially in women with a history of prior tubal disease.
29 Pojavi se lahko tudi zunajmaternična nosečnost (zarodek vgnezden izven maternice), še posebej pri ženskah, ki so imele bolezni jajcevodov.
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.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta
- The solvent is water for injection.
- Vehikel je voda za injekcije.
Each vial of powder contains 75 IU of lutropin alfa and each vial of solvent contains 1 ml of water for injection.
Vsaka viala s praškom vsebuje 75 i. e. lutropina alfa in vsaka viala z vehiklom vsebuje 1 ml vode za injekcije.
30 België/Belgique/Belgien MERCK NV/SA Brusselsesteenweg 288 B-3090 Overijse Tél/Tel: +32-2-686 07 11
30 België/ Belgique/ Belgien MERCK NV/ SA Brusselsesteenweg 288 B- 3090 Overijse Tél/ Tel: +32- 2- 686 07 11
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Povzetek pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene raziskave, na podlagi česar je oblikoval priporočila glede uporabe zdravila.
Lyrica is a capsule for oral administration, containing the active substance pregabalin.
Zdravilo Lyrica so kapsule za peroralno uporabo, ki vsebuje zdravilno učinkovino pregabalin.
The capsules are white (25 mg, 50 mg and 150 mg), white and orange (75 mg, 225mg and 300mg), orange (100 mg) and light orange (200 mg).
Kapsule so bele (25 mg, 50 mg in 150 mg), bele in oranžne (75 mg, 225 mg in 300 mg), oranžne (100 mg) in svetlo oranžne barve (200 mg).
Lyrica is used to treat adult patients with: • Neuropathic pain: this is pain that is due to damage to nerves.
Zdravilo Lyrica se uporablja za zdravljenje odraslih bolnikov z: • nevropatsko bolečino: to je bolečina, ki je posledica poškodbe živcev.
Lyrica is used when patients have partial seizures that cannot be controlled by their current treatment only (Lyrica is used as an ‘ add-on ’ to existing treatment), • Generalised anxiety disorder: this is a disorder where the patient suffers from prolonged excessive anxiety and worry that are difficult to control.
Zdravilo Lyrica se lahko uporablja pri periferni nevropatski bolečini, kot je bolečina pri bolnikih s sladkorno boleznijo ali bolnikih, ki so imeli herpes zoster (pasovec), in centralni nevropatski bolečini, kot je bolečina pri bolnikih s poškodbo hrbtenjače. • epilepsijo: zdravilo Lyrica se uporablja pri bolnikih z delnimi (parcialnimi) napadi, ki jih samo z njihovim trenutnim zdravljenjem ni mogoče nadzorovati (zdravilo Lyrica se uporablja kot dodatek obstoječemu zdravljenju), • generalizirano anksiozno motnjo: to je motnja, pri kateri je bolnik dalj časa čezmerno anksiozen in zaskrbljen, kar je težko nadzorovati.
Lyrica is given either as two or three doses a day, and the total dose varies from 150 mg to 600 mg (maximum) per day.
Zdravilo Lyrica se jemlje v dveh ali treh dnevnih odmerkih, skupen dnevni odmerek pa se giblje med 150 mg in 600 mg (največ).
Starting doses are increased gradually, after an interval of 3 to 7 days, until the most effective dose is reached.
Začetni odmerki se postopoma povečujejo v časovnih presledkih od 3 do 7 dni, dokler ni dosežen najučinkovitejši odmerek.
Stopping treatment with Lyrica should also be done gradually, over at least one week.
Tudi prenehanje zdravljenja z zdravilom Lyrica mora potekati postopno, trajati mora najmanj en teden.
The capsules should be swallowed whole with water, and can be taken with or without food.
Kapsule je treba pogoltniti cele z vodo, lahko se jih jemlje s hrano ali brez nje.
Patients who have kidney problems will need lower doses.
Bolniki, ki imajo težave z ledvicami, potrebujejo nižje odmerke.
The active substance in Lyrica, pregabalin, is similar in structure to the body’ s own ‘ neurotransmitter’ GABA (gamma-amino butyric acid), but has very different biological effects.
Zdravilna učinkovina v zdravilu Lyrica pregabalin ima podobno strukturo kot telesu lasten » živčni prenašalec « GABA (gama- aminomaslena kislina), vendar ima bistveno drugačne biološke učinke.
Neurotransmitters are substances in the body that relay signals across from one nerve to the other.
Živčni prenašalci so snovi v telesu, ki prenašajo signale od enega živca do drugega.
The exact way pregabalin works is not fully known.
Točno delovanje pregabalina ni v celoti znano.
It seems that pregabalin acts on the way calcium ions enter nerve cells, making the nerves in the central nervous system less excitable, and reducing the release of other neurotransmitters.
Pregabalin najverjetneje vpliva na vstopanje kalcijevih ionov v živčne celice, s čimer zmanjšuje vzdražljivost živcev v centralnem živčnem sistemu ter zmanjšuje sproščanje drugih živčnih prenašalcev.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Lyrica been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Lyrica raziskano?
Lyrica has been studied in 21 studies, where it was compared with a placebo (a dummy treatment).
Zdravilo Lyrica je bilo preučevano v 21 raziskavah, kjer so ga primerjali s placebom.
Nine studies looked at peripheral neuropathic pain (about half of the patients had diabetic neuropathy and the other half had post- herpetic neuralgia) and one study was in central neuropathic pain (137 patients with spinal cord injury).
V zvezi z nevropatsko bolečinoje bilo preučevano v desetih raziskavah, ki so vključevale več kot 3100 bolnikov: v devetih raziskavah so preučevali periferno nevropatsko bolečino (približno pol bolnikov je imelo diabetično nevropatijo, druga polovica pa postherpetično nevralgijo), v eni raziskavi pa centralno nevropatsko bolečino (137 bolnikov s poškodbo hrbtenjače).
The effectiveness of Lyrica was measured using a pain score questionnaire.
Učinkovitost zdravila Lyrica so merili z vprašalnikom za točkovanje bolečine.
In epilepsy, three studies involved 1,328 patients, and the measure of the effectiveness of Lyrica was based on the difference in the monthly number of seizures before and during treatment.
Glede epilepsije je bilo preučevano v okviru treh raziskav, ki so vključevale 1328 bolnikov, merilo za učinkovitost zdravila Lyrica pa bila razlika v mesečnem številu napadov pred zdravljenjem in med njim.
In the treatment of generalised anxiety disorder, eight studies involved over 3,000 patients, the effectiveness of Lyrica was measured using an anxiety questionnaire (Hamilton Anxiety Rating Scale).
Pri zdravljenju generalizirane anksiozne motnje je bilo v osmih raziskavah vključenih več kot 3000 bolnikov, učinkovitost zdravila Lyrica pa so merili z vprašalnikom o anksioznosti (Hamiltonova lestvica za oceno anksioznosti).
One study also specifically looked at how long it took for anxiety symptoms to return (relapses) with and without treatment.
Ena raziskava je tudi preučevala, čez koliko časa so se simptomi anksioznosti ponovili (recidiv) pri zdravljenju in brez njega.
What benefit has Lyrica shown during the studies?
Kakšne koristi je zdravilo Lyrica izkazalo med raziskavami?
In neuropathic pain studies, Lyrica was more effective than placebo in decreasing the pain scores.
Pri raziskavah glede nevropatske bolečine je bilo zdravilo Lyrica učinkovitejše od placeba pri zmanjšanju točkovanja bolečine.
In peripheral neuropathic pain, over one third of the patients treated with Lyrica had a 50% or more improvement in pain score, compared to 18% for the patients treated with a placebo.
Pri periferni nevropatski bolečini je pri več kot tretjini bolnikov, zdravljenih z zdravilom Lyrica, prišlo do izboljšanja točkovanja bolečine za 50% ali več v primerjavi z 18% bolnikov, ki so se zdravili s placebom.
In central neuropathic pain, 21.7% of patients treated with Lyrica had a 50% or more improvement in pain score compared to 7.5% of the patients treated with a placebo.
Pri centralni nevropatski bolečini je bilo pri 21, 7% bolnikov, zdravljenih z zdravilom Lyrica, doseženo izboljšanje točkovanja bolečine za 50% ali več v primerjavi s 7, 5% bolnikov, ki so se zdravili s placebom.
In epilepsy, Lyrica was effective in reducing the number of seizures: the percentage of patients treated with Lyrica who had a 50% or more improvement in their monthly seizure was about 45% when they received 600 mg/ day, and about 35% when they received 300 mg a day, compared to about 10% of patients treated with placebo.
Pri epilepsiji je bilo zdravilo Lyrica učinkovito pri zmanjševanju števila napadov: delež bolnikov, zdravljenih z zdravilom Lyrica, ki so imeli izboljšanje mesečnih napadov za 50% ali več, je bil pri dnevnem odmerku 600 mg približno 45% in pri dnevnem odmerku 300 mg približno 35%, v primerjavi s približno 10% pri bolnikih, ki so se zdravili s placebom.
Lyrica was more effective than placebo in generalised anxiety disorders: an improvement of at least 50% in the anxiety questionnaire score was seen in over half of the patients treated with Lyrica, compared to 38% of the patients treated with a placebo.
Zdravilo Lyrica je bilo pri generaliziranih anksioznih motnjah učinkovitejše od placeba: izboljšanje za vsaj 50% pri rezultatih vprašalnika anksioznosti je bilo opaženo pri več kot polovici bolnikov, zdravljenih z zdravilom Lyrica, v primerjavi z 38% bolnikov, ki so se zdravili s placebom.
The most common side effects (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness).
Najpogostejša neželena stranska učinka (opažena pri več kot 1 od 10 bolnikov) sta omotica in zaspanost.
For the full list of all side effects reported with Lyrica, see the Package Leaflet.
Celoten seznam vseh neželenih stranskih učinkov, o katerih so poročali pri uporabi zdravila Lyrica, najdete v Navodilih za uporabo.
Lyrica should not be used in people who may be hypersensitive (allergic) to pregabalin or to any of the other ingredients.
Zdravila Lyrica ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) pregabalin ali katero drugo sestavino.
The Committee for Medicinal Products for Human Use (CHMP) decided that Lyrica’ s benefits are greater than its risks for the treatment of peripheral and central neuropathic pain in adults, as therapy in adults with partial seizures with or without secondary generalisation, and for the treatment of Generalised Anxiety Disorder in adults.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Lyrica pri zdravljenju periferne in centralne nevropatske bolečine pri odraslih, kot terapija pri odraslih s parcialnimi napadi s sekundarno generalizacijo ali brez nje, in za zdravljenje generalizirane anksiozne motnje pri odraslih, večje od z njim povezanih tveganj.
They recommended that Lyrica be given marketing authorisation.
Zato je priporočil, da se za zdravilo Lyrica podeli dovoljenje za promet.
The full EPAR for Lyrica can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Lyrica je na voljo tukaj.
LYRICA 25 mg hard capsules
LYRICA 25 mg trde kapsule
Lyrica capsules also contain lactose monohydrate.
Kapsule Lyrica vsebujejo tudi laktozo monohidrat.
Hard capsule White, marked “ Pfizer ” on the cap and “ PGN 25 ” on the body with black ink.
Trde kapsule Bela kapsula, ki ima na zgornjem delu kapsule s črnim črnilom izpisano oznako “ Pfizer ” in na spodnjem delu “ PGN 25 ”.
LYRICA is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Zdravilo Lyrica je indicirano za zdravljenje generalizirane anksiozne motnje (GAD - Generalised Anxiety Disorder) pri odraslih.
The dose range is 150 to 600 mg per day given in either two or three divided doses.
Odmerno območje je od 150 do 600 mg na dan v dveh ali treh deljenih odmerkih.
Pregabalin treatment can be started at a dose of 150 mg per day.
Zdravljenje s pregabalinom se lahko začne s 150 mg na dan.
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.
Glede na bolnikov odziv in prenašanje je mogoče čez 3 do 7 dni odmerek zvečati na 300 mg na dan in – če je potrebno – čez nadaljnjih 7 dni na največji odmerek 600 mg na dan.
Pregabalin treatment can be started with a dose of 150 mg per day.
Zdravljenje s pregabalinom se lahko začne s 150 mg na dan.
Based on individual patient response and tolerability, the dosage may be increased to 300 mg per day after 1 week.
Glede na bolnikov odziv in prenašanje je mogoče odmerek čez 1 teden zvečati na 300 mg na dan.
The maximum dosage of 600 mg per day may be achieved after an additional week.
Po dodatnem tednu je mogoče doseči največji odmerek 600 mg na dan.
2 Generalised Anxiety Disorder
2 Generalizirana anksiozna motnja
Based on individual patient response and tolerability, the dosage may be increased to 300 mg per day after 1 week.
Glede na bolnikov odziv in prenašanje se lahko odmerek po enem tednu poveča na 300 mg na dan.
Following an additional week the dosage may be increased to 450 mg per day.
Še en teden zatem se lahko odmerek poveča na 450 mg na dan.
The maximum dosage of 600 mg per day may be achieved after an additional week.
Največji dovoljeni odmerek, ki se lahko doseže en teden pozneje, je 600 mg na dan.
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).
Če je treba uporabo pregabalina prekiniti, ga je skladno s trenutno klinično prakso, ne glede na indikacijo, priporočljivo zmanjševati postopoma vsaj 1 teden (glejte poglavje 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:
Očistek pregabalina je neposredno sorazmeren očistku kreatinina (glejte poglavje 5. 2), zato je treba pri bolnikih z okrnjenim delovanjem ledvic odmerjanje individualno prilagoditi glede na očistek kreatinina (OČkr), kot prikazuje preglednica 1, po naslednji formuli:
⎡ 1.23 × [140 - age (years)] x weight (kg) ⎤
⎡1. 23 × [140 - starost (leta)] x masa (kg) ⎤ ⎥ (x 0. 85 za bolnice) OČkr (ml/ min) = ⎢ ⎥
⎣
⎢ ⎣
serum creatinine (μmol/l)
kreatinin v serumu (μmol/ l)
In addition to the daily dose, a supplementary dose should be given immediately following every 4- hour haemodialysis treatment (see Table 1).
Poleg dnevnega odmerka morajo bolniki takoj po vsaki 4- urni hemodializi dobiti dodaten odmerek (glejte preglednico 1).
Pregabalin dosage adjustment based on renal function
Prilagoditev odmerjanja pregabalina glede na delovanje ledvic
Total Pregabalin Daily dose *
celotni dnevni odmerek odmerna shema očistek kreatinina pregabalina * (OČkr) (ml/ min)
Starting dose (mg/day)
začetni odmerek (mg/ dan)
Maximum dose (mg/day)
največji odmerek (mg/ dan)
≥ 60 ≥30 - < 60 ≥15 - < 30 < 15
≥ 60 ≥30 < 60 ≥15 < 30
150 75 25 – 50 25
150 75 25– 50
BID or TID BID or TID Once Daily or BID Once Daily
2 - ali 3- krat/ dan 2 - ali 3- krat/ dan 1 - krat/ dan ali 2 - krat/ dan
* Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose + Supplementary dose is a single additional dose
3- krat/ dan = tri deljene odmerke 2- krat/ dan = dva deljena odmerka * Celotni dnevni odmerek (mg/ dan) je treba razdeliti, kot navaja odmerna shema, da dobimo mg/ odmerek. + Dodaten odmerek je posamičen dopolnilni odmerek.
3 Use in patients with hepatic impairment
Uporaba pri bolnikih z okvaro jeter
No dosage adjustment is required for patients with hepatic impairment (see section 5.2).
Pri bolnikih z okvaro jeter odmerjanja ni treba prilagajati (glejte poglavje 5. 2).
Use in children and adolescents
3 Uporaba pri otrocih in mladostnikih
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).
Uporaba zdravila Lyrica ni priporočljiva pri otrocih, mlajših od 12 let, in mladostnikih (od 12. do 17. leta starosti), ker ni dovolj podatkov o varnosti in učinkovitosti (glejte poglavje 5. 3).
Use in the elderly (over 65 years of age)
Uporaba pri starejših (po 65. letu starosti)
In accordance with current clinical practice, some diabetic patients who gain weight on pregabalin treatment may need to adjust hypoglycaemic medications.
Skladno s trenutno klinično prakso moramo bolnikom z diabetesom, ki pri zdravljenju s pregabalinom pridobijo na telesni masi, prilagoditi hipoglikemična zdravila.
There have been reports in the postmarketing experience of hypersensitivity reactions, including cases of angioedema.
Med pomarketinško uporabo so bile opisane preobčutljivostne reakcije, vključno z angioedemom.
Pregabalin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in the elderly population.
Zdravljenje s pregabalinom je bilo povezano z omotico in zaspanostjo, ki lahko v starejši populaciji zveča pogostnost nezgodnih poškodb (padcev).
There have also been post marketing reports of loss of consciousness, confusion and mental impairment.
V pomarketinškem obdobju so poročali tudi o izgubi zavesti, zmedenosti in poslabšanju mentalnih sposobnosti.
Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medication.
Zato je bolnikom potrebno svetovati, naj bodo previdni, dokler ni znano, kako zdravilo učinkuje na njih.
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.
V kontroliranih študijah je zamegljen vid navajal večji delež bolnikov, ki so dobivali pregabalin, kot bolnikov, ki so dobivali placebo; med nadaljnjo uporabo je zamegljen vid v večini primerov izginil.
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).
V kliničnih študijah, ki so vključevale oftalmološke preglede, je bila incidenca zmanjšane ostrine vida in sprememb vidnega polja večja med bolniki, ki so dobivali pregabalin, kot med tistimi, ki so dobivali placebo, incidenca fundoskopskih sprememb pa je bila večja pri bolnikih, ki so dobivali placebo (glejte poglavje 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.
Med pomarketinško uporabo so poročali tudi o neželenih učinkih na vid; večinoma je šlo za prehodno zamegljenost vida ali druge spremembe ostrine vida.
Cases of renal failure have been reported and discontinuation of pregabalin did show reversibility of this adverse effect.
Poročali so o primerih odpovedi ledvic; ob prekinitvi zdravljenja je bil ta neželeni učinek reverzibilen.
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.
Ni zadostnih podatkov za ukinitev sočasnih antiepileptičnih zdravil in prehod na monoterapijo s pregabalinom, ko je pri dodatnem zdravljenju s pregabalinom dosežen nadzor nad napadi.
The following events have been mentioned: insomnia, headache, nausea, diarrhoea, flu syndrome, nervousness, depression, pain, sweating and dizziness.
Opisani so naslednji pojavi: nespečnost, glavobol, navzea, driska, gripozni sindrom, živčnost, depresija, bolečine, znojenje in omotica.
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.
Kar zadeva prekinitev dolgotrajnega zdravljenja s pregabalinom, ni podatkov o incidenci in resnosti odtegnitvenih simptomov v povezavi s trajanjem uporabe in odmerkom pregabalina.