natgillin/translations-raw huggingface dataset:
Ramsgate Road, Sandwich Kent, CT 13 9NJ UK
Peroralna uporaba
Film-coated tablets
tablete
5 France
Francija
PFIZER HELLAS 243 Messoghion Ave., Neo Psychiko 154 51 Greece
PFIZER HELLAS 243 Messoghion Ave., Neo Psychiko
Pfizer Aps Lautrupvang 8
Pfizer Aps Lautrupvang 8 2750 Ballerup Danska
Ireland
7 Danska
Pfizer Healthcare Ireland 9 Riverwalk, National Digital Pk, Citywest Business Campus, Dublin 24, Ireland c/ o Pfizer Ltd.
Pfizer Healthcare Ireland 9 Riverwalk, National Digital Pk, Citywest Business Campus, Dublin 24, Irska c/ o Pfizer Ltd.
Pfizer Healthcare Ireland
Pfizer Healthcare Ireland 9 Riverwalk, National Digital Pk, Citywest Business Campus, Dublin 24, Irska c/ o Pfizer Ltd.
Walton Oaks Dorking Road Tadworth, Surrey KT20 7NS
Pfizer Healthcare Ireland 9 Riverwalk, National Digital Pk, Citywest Business Campus, Dublin 24, Irska c/ o Pfizer Ltd.
Pfizer Healthcare Ireland 9 Riverwalk, National Digital Pk, Citywest Business Campus, Dublin 24, Ireland c/ o Pfizer Ltd.
Pfizer Healthcare Ireland
10 Latvia
Latvija
Pfizer Limited.
Pfizer Limited.
Ramsgate Road Sandwich, Kent
Ramsgate Road Sandwich, Kent CT13 9NJ, UK
Pfizer S. A..
Pfizer S. A..
Boulevard de la Plaine 17 B-1050 Bruxelles Belgium
Boulevard de la Plaine 17 B- 1050 Bruxelles Belgija
Boulevard de la Plaine 17 B-1050 Bruxelles Belgium
Boulevard de la Plaine 17
Boulevard de la Plaine 17 B-1050
Boulevard de la Plaine 17 B- 1050 Bruxelles Belgija
Pfizer Hellas A. E., Alketou 5, 11633 Athens Greece
Pfizer Hellas A. E., Alketou 5, 11633 Athens Grčija
Norway
12 Norveška
Parke-Davis GmbH Pfizerstr 1, 76139 Karlsruhe, Germany
Parke- Davis GmbH Pfizerstr 1, 76139 Karlsruhe, Nemčija
Portugal
13 Portugalska
Pfizer Luxembourg SARL 283, route d’ Arlon L-8011 Strassen Luxembourg
Pfizer Luxembourg SARL 283, route d’ Arlon L- 8011 Strassen Luksemburg
Pfizer Luxembourg SARL
Pfizer Luxembourg SARL 283, route d’ Arlon L- 8011 Strassen Luksemburg
Pfizer Luxembourg SARL, branch office Dubravska cesta 2, 841 04 Bratislava, Slovak Republic
Pfizer Luxembourg SARL, branch office Dubravska cesta 2, 841 04 Bratislava, Slovaška
Pfizer Luxembourg SARL, branch office Dubravska cesta 2, 841 04 Bratislava, Slovak Republic
16 Pfizer Luxembourg SARL, branch office Dubravska cesta 2, 841 04 Bratislava, Slovaška
Ramsgate Road Sandwich Kent, CT13 9NJ, UK C/ o Walton Oaks Dorking Road Tadworth, Surrey KT20 7NS
Ramsgate Road Sandwich
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
ZNANSTVENI ZAKLJUČKI IN RAZLOGI ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
20 SCIENTIFIC CONCLUSIONS
20 ZNANSTVENI ZAKLJUČKI
Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid) but the precise mechanism of action of gabapentin is not yet known.
Gabapentin je strukturno soroden nevrotransmitorju GABA (gama- aminomaslena kislina), vendar njegov natančen mehanizem delovanja še ni znan.
Therefore, the MAH proposal of a harmonised wording was endorsed; as follows: “ Gabapentin is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults .”
„ Gabapentin je indiciran za zdravljenje periferne nevropatske bolečine, npr. boleče diabetične nevropatije in postherpetične nevralgije pri odraslih. “
A clinical trial of adjunctive treatment of partial seizures in paediatric subjects, ranging in age from 3 to 12 years, showed a numerical but not statistically significant difference in the 50% responder rate in favour of the gabapentin group compared to placebo.
Klinično preskušanje dodatnega zdravljenja parcialnih napadov pri otrocih, starih od 3 do 12 let, je pokazalo številčno, vendar statistično nepomembno razliko v stopnji 50- odstotnega odziva v korist skupine bolnikov, ki so prejemali gabapentin, v primerjavi s skupino bolnikov, ki so prejemali placebo.
Additional post-hoc analyses of the responder rates by age did not reveal a statistically significant effect of age, either as a continuous or dichotomous variable (age groups 3-5 and 6-12 years).
Kljub tem skromnim rezultatom CHMP ob upoštevanju zadostnega varnostnega profila in zdravstvene potrebe v tej populaciji otrok soglaša z naslednjo indikacijo:
In spite of these modest results, taking into consideration the adequate safety profile and the medical need in this paediatric population, the CHMP agreed to the following indication: “ Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1) .” An update of efficacy data in children has been made in section 5.1.
„ Gabapentin je indiciran kot dodatno zdravljenje pri odraslih in otrocih, starih 6 let in več, ki imajo parcialne napade s sekundarno generalizacijo ali brez nje (glejte poglavje 5. 1). “ V poglavju 5. 1 so posodobljeni podatki o učinkovitosti pri otrocih.
21 Therefore, the following indication was agreed by the CHMP: “ Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above .” The posology is to be adjusted individually depending on response and tolerability.
„ Gabapentin je indiciran kot monoterapija pri odraslih in mladostnikih, starih 12 let in več, ki imajo parcialne napade s sekundarno generalizacijo ali brez nje. “ Odmerjanje je potrebno prilagoditi posamezniku glede na odziv in prenašanje.
• Safety issues
•
The absence of adequate long term studies (more than 36 weeks) in children to assess growth, learning, intelligence, and development in children and adolescents, is mentioned in section 4.4.
V poglavju 4. 4 je omenjena odsotnost zadostnih dolgoročnih raziskav (ki trajajo dlje kot 36 tednov) pri otrocih za vrednotenje rasti, učenja, inteligence in razvoja otrok in mladostnikov.
Benefit/ Risk considerations
Pomisleki glede razmerja med koristmi in tveganji
Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CHMP considered that the benefit/ risk ratio of neurontin and associated names is favourable relating to:
CHMP na podlagi dokumentacije, ki jo je predložil MAH, in znanstvene razprave znotraj Odbora meni, da je razmerje med koristmi in tveganji za zdravilo Neurontin in povezana imena ugodno v zvezi z:
Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1).
Gabapentin je indiciran kot dodatno zdravljenje pri odraslih in otrocih, starih 6 let in več, ki imajo parcialne napade s sekundarno generalizacijo ali brez nje (glejte poglavje 5. 1).
Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above.
Gabapentin je indiciran kot monoterapija pri odraslih in mladostnikih, starih 12 let in več, ki imajo parcialne napade s sekundarno generalizacijo ali brez nje.
the scope of the referral was the harmonisation of the Summary of Product Characteristics, labelling and package leaflet
je bil namen posvetovalnega postopka uskladitev Povzetka glavnih značilnosti zdravila, označevanja in navodil za uporabo
the Summary of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
so bili Povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo, ki so jih predlagali imetniki dovoljenja za promet z zdravilom, ovrednoteni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora,
22 the CHMP has recommended amendments of the Summary of Products Characteristic, Labelling and Package Leaflet, as set out in Annexe III of the CHMP opinion for Neurontin and associated names (see Annexe I of the opinion).
22 CHMP priporoča dopolnitev Povzetka glavnih značilnosti zdravila, označevanja in Navodil za uporabo, kakor je opredeljeno v Dodatku III Mnenja CHMP za zdravilo Neurontin in povezana imena (glejte Dodatek I Mnenja).
24 SUMMARY OF PRODUCT CHARACTERISTICS
24 POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Neurontin and associated names 100 mg hard capsule Neurontin and associated names 300 mg hard capsule Neurontin and associated names 400 mg hard capsule Neurontin and associated names 600 mg film-coated tablet Neurontin and associated names 800 mg film-coated tablet
Neurontin in povezana imena 100 mg trde kapsule Neurontin in povezana imena 300 mg trde kapsule Neurontin in povezana imena 400 mg trde kapsule Neurontin in povezana imena 600 mg filmsko obložene tablete Neurontin in povezana imena 800 mg filmsko obložene tablete
Each 100 mg hard capsule contains 100 mg of gabapentin.
Ena 100 mg trda kapsula vsebuje 100 mg gabapentina.
[Description to be completed nationally]
[Izpolni država članica]
Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1).
26 Gabapentin je indiciran kot dodatna terapija za zdravljenje parcialnih epileptičnih napadov s sekundarno generalizacijo ali brez nje pri odraslih in otrocih, starih 6 let in več (glejte poglavje 5. 1).
26 Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above.
Gabapentin je indiciran kot monoterapija za zdravljenje parcialnih epileptičnih napadov s sekundarno generalizacijo ali brez nje pri odraslih in mladostnikih, starih 12 let in več.
Treatment of peripheral neuropathic pain
Zdravljenje perifernih nevropatskih bolečin
Gabapentin is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults.
Gabapentin je indiciran za zdravljenje perifernih nevropatskih bolečin, npr. boleče diabetične nevropatije in poherpetične nevralgije, pri odraslih.
Gabapentin can be given with or without food and should be swallowed whole with sufficient fluid- intake (e. g. a glass of water).
Pogoltniti ga je treba celega in z zadostno količino tekočine (npr. s kozarcem vode).
Table 1 DOSING CHART – INITIAL TITRATION Day 1 300 mg once a day
Tabela 1 PREGLEDNICA ODMERJANJA – UVODNO TITRIRANJE 1. dan 300 mg enkrat na dan
Day 2 300 mg two times a day
2. dan 300 mg dvakrat na dan
Day 3 300 mg three times a day
3. dan 300 mg trikrat na dan
Epilepsy Epilepsy typically requires long-term therapy.
Epilepsija praviloma zahteva dolgotrajno zdravljenje.
In clinical trials, the effective dosing range was 900 to 3600 mg/ day.
V kliničnih preskušanjih je bil učinkovit razpon odmerkov od 900 do 3600 mg/ dan.
Therapy may be initiated by titrating the dose as described in Table 1 or by administering 300 mg three times a day (TID) on Day 1.
Zdravljenje je mogoče začeti s titriranjem odmerka, kot prikazuje tabela 1, ali z uporabo 300 mg trikrat na dan 1. dan.
Thereafter, based on individual patient response and tolerability, the dose can be further increased in 300 mg/ day increments every 2-3 days up to a maximum dose of 3600 mg/ day.
Potem je mogoče odmerek glede na bolnikov odziv in prenašanje povečevati po 300 mg/ dan na 2 do 3 dni do največjega odmerka 3600 mg/ dan.
The minimum time to reach a dose of 1800 mg/ day is one week, to reach 2400 mg/ day is a total of 2 weeks, and to reach 3600 mg/ day is a total of 3 weeks.
Najkrajši čas za doseganje odmerka 1800 mg/ dan je en teden, za doseganje 2400 mg/ dan je skupno 2 tedna, za doseganje 3600 mg/ dan pa skupno 3 tedne.
Dosages up to 4800 mg/ day have been well tolerated in long-term open-label clinical studies.
V dolgotrajnih odprtih kliničnih študijah so bolniki dobro prenašali odmerke do 4800 mg/ dan.
The starting dose should range from 10 to 15 mg/ kg/ day and the effective dose is reached by upward titration over a period of approximately three days.
Začetni odmerek mora biti med 10 in 15 mg/ kg/ dan, učinkoviti odmerek pa dosežemo s povečevanjem v obdobju približno treh dni.
The effective dose of gabapentin in children aged 6 years and older is 25 to 35 mg/ kg/ day.
Učinkoviti odmerek gabapentina pri otrocih, starih 6 let in več, je od 25 do 35 mg/ kg/ dan.
Dosages up to 50 mg/ kg/ day have been well tolerated in a long- term clinical study.
V dolgotrajni klinični študiji so bolniki dobro prenašali odmerke do 50 mg/ kg/ dan.
27 Peripheral neuropathic pain
27 Za optimizacijo zdravljenja z gabapentinom ni treba kontrolirati njegove koncentracije v plazmi.
Alternatively, the starting dose is 900 mg/ day given as three equally divided doses.
Druga možnost je uporaba začetnega odmerka 900 mg/ dan v treh enakih deljenih odmerkih.
If a patient requires dosing longer than 5 months for the treatment of peripheral neuropathic pain, the treating physician should assess the patient’ s clinical status and determine the need for additional therapy.
Če bolnik zaradi perifernih nevropatskih bolečin potrebuje več kot 5- mesečno zdravljenje, mora lečeči zdravnik oceniti bolnikovo klinično stanje in ugotoviti, ali je potrebna dodatna terapija.
In patients with poor general health, i. e., low body weight, after organ transplantation etc., the dose should be titrated more slowly, either by using smaller dosage strengths or longer intervals between dosage increases.
Pri bolnikih, ki so v slabem zdravstvenem stanju, tj. imajo majhno telesno maso, so bili deležni presaditve organa itn., je treba odmerek titrirati počasneje, bodisi z uporabo manjših odmernih jakosti ali z daljšimi presledki med povečanji odmerka.
Dosage adjustment is recommended in patients with compromised renal function as described in Table 2 and/ or those undergoing haemodialysis.
Pri bolnikih z okvarjenim delovanjem ledvic in/ ali na hemodializi je priporočljivo prilagoditi odmerek, kot prikazuje tabela 2.
Total daily dose should be administered as three impairment (creatinine clearance < 79 ml/ min). b To be administered as 300 mg every other day. c
Tabela 2 ODMERJANJE GABAPENTINA PRI ODRASLIH GLEDE NA DELOVANJE LEDVIC celotni dnevni odmereka (mg/ dan) očistek kreatinina (ml/ min) ≥ 80 900– 3600 50– 79 600– 1800 30– 49 300– 900 150b– 600 15– 29 c 150b– 300 < 15 a Celotni dnevni odmerek je treba razdeliti na tri dele.
For patients with creatinine clearance < 15 ml/ min, the daily dose should be reduced in proportion to creatinine clearance (e. g., patients with a creatinine clearance of 7.5 ml/ min should receive one-half the daily dose that patients with a creatinine clearance of 15 ml/ min receive).
Manjši odmerki so za bolnike z okvaro ledvic (očistek kreatinina < 79 ml/ min). b Uporabite po 300 mg vsak drugi dan. c Bolnikom z očistkom kreatinina < 15 ml/ min je treba dnevni odmerek zmanjšati sorazmerno očistku kreatinina (tako morajo npr. bolniki z očistkom kreatinina 7, 5 ml/ min dobivati polovico tistega dnevnega odmerka, ki ga dobivajo bolniki z očistkom kreatinina 15 ml/ min).
28 Use in patients undergoing haemodialysis
28 Uporaba pri bolnikih na hemodializi
If a patient develops acute pancreatitis under treatment with gabapentin, discontinuation of gabapentin should be considered (see section 4.8).
Če se bolniku med zdravljenjem z gabapentinom pojavi akutni pankreatitis, morate razmisliti o prekinitvi te terapije (glejte poglavje 4. 8).
Although there is no evidence of rebound seizures with gabapentin, abrupt withdrawal of anticonvulsants in epileptic patients may precipitate status epilepticus (see section 4.2).
Čeprav pri dajanju gabapentina ni dokazov o povratnih, ponavljajočih se napadih, lahko nenadna prekinitev antikonvulzivov pri epileptičnih bolnikih sproži status epilepticus (glejte poglavje 4. 2).
The effects of long-term (greater than 36 weeks) gabapentin therapy on learning, intelligence, and development in children and adolescents have not been adequately studied.
Učinki dolgotrajnega (več kot 36- tedenskega) zdravljenja z gabapentinom na učenje, inteligenco in razvoj otrok in mladostnikov niso zadostno raziskani.
Laboratory tests False positive readings may be obtained in the semi-quantitative determination of total urine protein by dipstick tests.
Laboratorijske preiskave Pri semikvantitativnem določanju celotnih beljakovin v urinu s testnimi trakovi se lahko pojavijo lažno pozitivni izvidi.
It is therefore recommended to verify such a positive dipstick test result by methods based on a different analytical principle such as the Biuret method, turbidimetric or dye-binding methods, or to use these alternative methods from the beginning.
Zato je pozitiven izvid s testnim trakom priporočljivo preveriti z načini, ki temeljijo na drugačnem analitičnem principu – npr. z biuretsko ali turbidimetrično metodo, ali vezavo barvila – ali že uvodoma uporabiti enega takšnih načinov.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine [this text will only be included in the capsules SPC].
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze tega zdravila ne smejo jemati [To besedilo bo vključeno le v SmPC- ju pri kapsulah].
29 4.5 Interaction with other medicinal products and other forms of interaction
29 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
In a study involving healthy volunteers (N=12), when a 60 mg controlled-release morphine capsule was administered 2 hours prior to a 600 mg gabapentin capsule, mean gabapentin AUC increased by 44% compared to gabapentin administered without morphine.
Ko so v študiji zdravih prostovoljcev (n = 12) 2 uri pred zaužitjem kapsule s 600 mg gabapentina uporabili 60- mg kapsulo morfina z nadzorovanim sproščanjem, se je povprečna AUC gabapentina povečala za 44% v primerjavi z uporabo gabapentina brez morfina.
Coadministration of gabapentin with oral contraceptives containing norethindrone and/ or ethinyl estradiol, does not influence the steady-state pharmacokinetics of either component.
Sočasna uporaba gabapentina s peroralnimi kontraceptivi, ki vsebujejo noretindron in/ ali etinilestradiol, v stanju dinamičnega ravnovesja ne vpliva na farmakokinetiko nobene od teh sestavin.
Coadministration of gabapentin with antacids containing aluminium and magnesium, reduces gabapentin bioavailability up to 24%.
Sočasna uporaba gabapentina z antacidi, ki vsebujejo aluminij in magnezij, zmanjša biološko uporabnost gabapentina do 24%.
The risk of birth defects is increased by a factor of 2 – 3 in the offspring of mothers treated with an antiepileptic medicinal product.
Tveganje za prirojene hibe je pri otrocih mater, ki dobivajo kakšno antiepileptično zdravilo, 2 - do 3- krat večje.
Multiple antiepileptic drug therapy may be associated with a higher risk of congenital malformations than monotherapy, therefore it is important that monotherapy is practised whenever possible.
Če je le mogoče, je zato treba uporabljati monoterapijo.
Specialist advice should be given to women who are likely to become pregnant or who are of childbearing potential and the need for antiepileptic treatment should be reviewed when a woman is planning to become pregnant.
Če ženska načrtuje nosečnost, je treba znova oceniti potrebo po antiepileptični terapiji.
No sudden discontinuation of antiepileptic therapy should be undertaken as this may lead to breakthrough seizures, which could have serious consequences for both mother and child.
Antiepileptične terapije ne smete prekiniti nenadoma, ker to lahko povzroči občasna poslabšanja napadov, ki imajo lahko resne posledice za mater in otroka.
Developmental delay in children of mothers with epilepsy has been observed rarely.
Pri otrocih mater z epilepsijo so v redkih primerih opažali razvojni zaostanek.
Studies in animals have shown reproductive toxicity (see section 5.3).
Študije na živalih so pokazale vpliv na reproduktivno toksičnost (glejte poglavje 5. 3).
30 Gabapentin is excreted in human milk.
Gabapentin se izloča v materino mleko.
4.7 Effects on ability to drive and use machines
30 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
The adverse reactions observed during clinical studies conducted in epilepsy (adjunctive and monotherapy) and neuropathic pain have been provided in a single list below by class and frequency (very common (> 1/ 10), common (> 1/ 100 ,< 1/10), uncommon (> 1/ 1000 ,< 1/100) and rare (> 1/10 ,000; < 1/1,000).
Neželeni učinki, zabeleženi v kliničnih študijah pri epilepsiji (pri dodatni terapiji ali monoterapiji) in nevropatskih bolečinah, so navedeni glede na vrsto in pogostnost: zelo pogosti (> 1/ 10), pogosti (> 1/ 100, < 1/ 10), občasni (> 1/ 1000, < 1/ 100) in redki (> 1/ 10, 000; < 1/ 1, 000).
Infections and infestations Very Common:
Infekcijske in parazitske bolezni Zelo pogosti:
Viral infection Common:
Pogosti:
Pneumonia, respiratory infection, urinary tract infection, infection, otitis media
virusna okužba pljučnica, okužba dihal, okužba sečil, okužba, otitis media
Blood and the lymphatic system disorders Common:
Pogosti:
leucopenia thrombocytopenia
levkopenija trombocitopenija
Immune system disorders Rare: allergic reactions (e. g. urticaria)
Presnovne in prehranske motnje Pogosti:
Metabolism and Nutrition Disorders Common:
anoreksija, povečan apetit
anorexia, increased appetite
Psihiatrične motnje
Psychiatric disorders Common:
Pogosti:
Nervous system disorders Very Common: somnolence, dizziness, ataxia, Common:
Pogosti:
convulsions, hyperkinesias, dysarthria, amnesia, tremor, insomnia, headache, sensations such as paresthesia, hypaesthesia, coordination abnormal, nystagmus, increased, decreased, or absent reflexes
somnolentnost, omotica, ataksija konvulzije, hiperkinezije, dizartrija, amnezija, tremor, nespečnost, glavobol, zaznave kot so parestezije ali hipestezija, nenormalna koordinacija, nistagmus, okrepljeni, oslabljeni ali odsotni refleksi
movement disorders (e. g. choreoathetosis, dyskinesia, dystonia)
motnje gibanja (npr. horeoatetoza, diskinezija, distonija)
visual disturbances such as amblyopia, diplopia
motnje vida, npr. ambliopija, diplopija
Ear and Labyrinth disorders Common:
Ušesne bolezni, vključno z motnjami labirinta Pogosti:
vertigo tinnitus
Srčne bolezni
31 Cardiac disorders Rare: palpitations
Redki:
Vascular disorder Common:
Žilne bolezni Pogosti:
hypertension, vasodilatation
hipertenzija, vazodilatacija
Respiratory, thoracic and mediastinal disorders Common:
31 Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti:
dyspnoea, bronchitis, pharyngitis, cough, rhinitis
dispneja, bronhitis, faringitis, kašelj, rinitis
Gastrointestinal disorders Common:
Pogosti:
Hepatobiliary disorders Rare: hepatitis, jaundice
Bolezni jeter, žolčnika in žolčevodov Redki:
Skin and subcutaneous tissue disorders Common:
hepatitis, zlatenica
Stevens-Johnson syndrome, angioedema, erythema multiforme, alopecia
Stevens- Johnsonov sindrom, angioedem, multiformni eritem, alopecija
Musculoskeletal, Common:
Bolezni mišično- skeletnega sistema in vezivnega tkiva Pogosti:
connective tissue and bone disorders arthralgia, myalgia, back pain, twitching
artralgija, mialgija, bolečine v hrbtu, trzanje
incontinence acute renal failure
inkontinenca akutna odpoved ledvic
and administration site conditions
Splošne težave in spremembe na mestu aplikacije Zelo pogosti:
Very Common: fatigue, fever Common:
Pogosti:
peripheral or generalized oedema, abnormal gait, asthenia, pain, malaise, flu syndrome
utrujenost, zvišana telesna temperatura periferni ali generalizirani edemi, nenormalna hoja, astenija, bolečine, splošno slabo počutje, gripozni sindrom
WBC (white blood cell count) decreased, weight gain Blood glucose fluctuations in patients with diabetes, elevated liver function tests
zmanjšanje števila levkocitov, povečanje telesne mase nihanje glukoze v krvi pri diabetikih, zvišani testi jetrne funkcije
Causality with gabapentin is unclear (see section 4.4).
Vzročna povezanost z gabapentinom ni jasna (glejte poglavje 4. 4).
32 4.9 Overdose
4. 9 Preveliko odmerjanje