natgillin/translations-raw huggingface dataset:
Respiratory tract infections, otitis media, convulsions and bronchitis were reported only in clinical studies in children.
Okužbe dihal, otitis media, konvulzije in bronhitis so bili opisani le v kliničnih študijah pri otrocih.
Do not use [Neurontin and associated names] after the expiry date which is stated on the carton after [to be completed nationally].
Zdravila [Neurontin in povezana imena] ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake [izpolni država članica].
Further, gabapentin may be used in combination with other antiepileptic medicinal products without concern for alteration of the plasma concentrations of gabapentin or serum concentrations of other antiepileptic medicinal products.
Poleg tega lahko gabapentin uporabimo v kombinaciji z drugimi antiepileptičnimi zdravili, ne da bi nas skrbela sprememba plazemske koncentracije gabapentina ali serumske koncentracije drugih antiepileptičnih zdravil.
DOSAGE OF GABAPENTIN IN ADULTS BASED ON RENAL FUNCTION Creatinine Clearance (ml/min)
ODMERJANJE GABAPENTINA PRI ODRASLIH GLEDE NA DELOVANJE LEDVIC očistek kreatinina (ml/min)
Reduced absorption of gabapentin at higher doses may limit drug absorption at the time of overdosing and, hence, minimize toxicity from overdoses.
Zmanjšana absorpcija gabapentina ob velikih odmerkih lahko omeji absorpcijo v primeru prevelikega odmerjanja in tako minimizira toksične učinke prevelikih odmerkov.
Regarding the indication in pain, the review of the previously available information and the review of the results of the newly conducted multicenter, placebo-controlled clinical study supports the use of Neurontin for the treatment of post-herpetic neuralgia and painful diabetic peripheral neuropathy.
V zvezi z indikacijo bolečin pregled predhodno dostopnih podatkov in pregled rezultatov novo opravljene multicentrične klinične raziskave, kontrolirane s placebom, podpirata uporabo zdravila Neurontin za zdravljenje postherpetične nevralgije in boleče diabetične periferne nevropatije.
[Neurontin and associated names] is not recommended for use in children below 6 years of age.
Zdravila [Neurontin in povezana imena] ni priporočljivo uporabljati pri otrocih, mlajših od 6 let.
Regarding the indication in epilepsy as monotherapy, based on the published studies, the CHMP considered that, although not statistically significant for all studies, the results were sufficiently consistent to support the clinical efficacy and safety of gabapentin as monotherapy.
CHMP v zvezi z indikacijo za epilepsijo v obliki monoterapije na podlagi objavljenih raziskav meni, da rezultati sicer niso bili statistično pomembni v vseh raziskavah, vendar so bili dovolj dosledni, da podpirajo klinično učinkovitost in varnost gabapentina kot monoterapije.
[Neurontin and associated names] can also be used on its own to treat adults and children over 12 years of age.
Zdravilo [Neurontin in povezana imena] je mogoče za zdravljenje odraslih in otrok, starejših od 12 let, uporabljati tudi samo.
If you forget to take [Neurontin and associated names] If you forget to take a dose, take it as soon as you remember unless it is time for your next dose.
Če pozabite vzeti odmerek, ga vzemite, čim se spomnite, razen če ni že čas za naslednjega.
The relevance of these various actions of gabapentin to the anticonvulsant effects remains to be established.
Pomen teh različnih učinkov za antikonvulzivno delovanje gabapentina še ni ugotovljen.
When in the judgment of the clinician there is a need for dose reduction, discontinuation, or substitution with an alternative medication, this should be done gradually over a minimum of one week.
Če zdravnik presodi, da je potrebno zmanjšanje odmerka, prekinitev zdravljenja ali zamenjava z drugim zdravilom, je to treba izvesti postopoma in v trajanju vsaj enega tedna.
United Kingdom Pfizer Ltd. Ramsgate Road Sandwich
Velika Britanija Pfizer Ltd. Ramsgate Road Sandwich
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.
Pfizer Luxembourg SARL 283, route d'Arlon L-8011 Strassen Luxembourg
Pfizer Luxembourg SARL 283, route d'Arlon L-8011 Strassen Luksemburg
< 6 Years Old 6 to 12 Years Old 17/99 (17.2%)
< 6 let 6 do 12 let
Therefore, gabapentin should be used with caution in patients with mixed seizures including absences.
Zato ga je treba pri bolnikih z mešanimi napadi, vključno z absencami, uporabljati previdno.
Gabapentin pharmacokinetics in children were determined in 50 healthy subjects between the ages of 1 month and 12 years.
Farmakokinetiko gabapentina pri otrocih so raziskali pri 50 zdravih preiskovancih, starih od 1 meseca do 12 let.
Your doctor will prescribe [Neurontin and associated names] for you to help treat your epilepsy when your current treatment is not fully controlling your condition.
Zdravnik vam bo predpisal zdravilo [Neurontin in povezana imena] kot pomoč pri zdravljenju epilepsije, če vam trenutno uporabljana zdravila bolezni ne obvladajo povsem.
If you stop taking [Neurontin and associated names] suddenly or before your doctor tells you, there is an increased risk of seizures.
Če zdravilo [Neurontin in povezana imena] nehate jemati nenadoma ali preden vam to naroči zdravnik, se poveča tveganje za epileptične napade.
Absolute bioavailability of a 300 mg capsule is approximately 60%.
Absolutna biološka uporabnost 300-mg kapsule je približno 60 %.
- the scope of the referral was the harmonisation of the Summary of Product Characteristics, labelling and package leaflet - 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,
- je bil namen posvetovalnega postopka uskladitev Povzetka glavnih značilnosti zdravila, označevanja in navodil za uporabo - 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,
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.
• Quality issues
• Vprašanja kakovosti
The binding site for gabapentin has been identified as the alpha2-delta subunit of voltage-gated calcium channels.
Vezavno mesto za gabapentin so identificirali kot alfa2-delta podenoto napetostno odvisnih kalcijevih kanalčkov.
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).
− if you develop signs such as persistent stomach pain, feeling sick and being sick contact your doctor immediately.
− če se vam pojavijo znaki, kot so vztrajna bolečina v trebuhu, slabo počutje in občutek slabosti, se morate nemudoma posvetovati z zdravnikom.
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).
• Incontinence
• inkontinenca
Pfizer Hellas A.E., Alketou 5, 11633 Athens Greece
Pfizer Hellas A.E., Alketou 5, 11633 Athens Grčija
Ae% = Percent of dose excreted unchanged into the urine from time 0 to 8 hours postdose
Ae% = odstotek odmerka, ki se je nespremenjen izločil v urinu od 0 do 8 ur po odmerku NP = ni podatka
Based on the available information and a literature search, no major safety issue seems to be associated with the administration of gabapentin.
Na podlagi dostopnih podatkov in pregleda literature ni mogoče najti večjih zadržkov glede varnosti, ki bi bili povezani z uporabo gabapentina.
Like all medicines, [Neurontin and associated names] can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo [Neurontin in povezana imena] neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
In addition, the clinical data support of the starting dose, the titration schedule, and the maximum total daily dosage of 3600 mg administered in three doses.
Poleg tega klinični podatki podpirajo začetni odmerek, razpored titracije in največji skupni dnevni odmerek 3600 mg, ki se razdeli v tri odmerke.
For renally impaired patients undergoing haemodialysis, the maintenance dose of gabapentin should be based on the dosing recommendations found in Table 2.
Pri bolnikih z okvaro ledvic, ki so na hemodializi, mora vzdrževalni odmerek gabapentina temeljiti na priporočilih za odmerjanje, navedenih v tabeli 2.
• Severe skin reactions that require immediate medical attention, swelling of the lips and face, skin rash and redness, hair loss
• hude kožne reakcije, ki zahtevajo takojšnjo zdravniško oskrbo, otekanje ustnic in obraza, izpuščaj in pordelost kože, izpadanje las in dlak
The total daily dose should be divided in three single doses, the maximum time interval between doses should not exceed 12 hours.
Celotni dnevni odmerek je treba razdeliti v tri posamične odmerke, najdaljši presledek med odmerki pa ne sme preseči 12 ur.
Epilepsy:
Epilepsija:
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).
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).
Because the effect on the nursing infant is unknown, it is not recommended to breast-feed your baby while using [Neurontin and associated names].
Ker učinek na dojenega otroka ni znan, dojenje med uporabo zdravila [Neurontin in povezana imena] ni priporočljivo.
Gabapentin is not considered effective against primary generalized seizures such as absences and may aggravate these seizures in some patients.
Gabapentin ne velja za učinkovitega proti primarnim generaliziranim napadom, npr. absencam; pri nekaterih bolnikih lahko takšne napade celo poslabša.
Gabapentin partially reduces responses to the glutamate agonist N-methyl-D-aspartate (NMDA) in some test systems in vitro, but only at concentrations greater than 100 µM, which are not achieved in vivo.
Gabapentin v nekaterih testnih sistemih in vitro delno zmanjša odzive na glutamatni agonist N-metil-Daspartat (NMDA), vendar le v koncentracijah nad 100µM, ki pa in vivo niso dosežene.
300 mg two times a day 300 mg three times a day
300 mg enkrat na dan 300 mg dvakrat na dan
• Blurred vision, double vision
• zamegljen vid, dvojen vid
Gabapentin bioavailability (fraction of dose absorbed) decreases with increasing dose which imparts non-linearity to pharmacokinetic parameters which include the bioavailability parameter (F) e.g. Ae%, CL/F, Vd/F.
Biološka uporabnost gabapentina (delež absorbiranega odmerka) se s povečevanjem odmerka zmanjšuje, kar povzroči nelinearnost farmakokinetičnih parametrov, ki vključujejo parameter biološke uporabnosti (F), npr. Ae%, CL/F, Vd/F.
This product contains lactose monohydrate.
Zdravilo vsebuje monohidrat laktoze.
PHARMACEUTICAL FORM Capsule, hard
FARMACEVTSKA OBLIKA Trde kapsule
If [Neurontin and associated names] and antacids containing aluminium and magnesium are taken at the same time, absorption of [Neurontin and associated names] from the stomach may be reduced.
Če zdravilo [Neurontin in povezana imena] vzamete hkrati z antacidi, ki vsebujejo aluminij ali magnezij, se lahko absorpcija zdravila [Neurontin in povezana imena] iz prebavil zmanjša.
Take the number of capsules or tablets as instructed by your doctor.
Vzemite toliko kapsul oz. tablet, kot vam je naročil zdravnik.
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.
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.
In animals, gabapentin readily enters the brain and prevents seizures from maximal electroshock, from chemical convulsants including inhibitors of GABA synthesis, and in genetic models of seizures.
Pri živalih gabapentin zlahka prestopa v možgane in preprečuje konvulzije zaradi maksimalnega elektrošoka, zaradi kemičnih konvulzivov (vključno z zaviralci sinteze GABA) in v genetskih modelih konvulzij.
The total daily dose should be divided in three single doses, the maximum time interval between the doses should not exceed 12 hours to prevent breakthrough convulsions.
Celotni dnevni odmerek je treba razdeliti v tri posamične odmerke, najdaljši presledek med odmerki pa ne sme preseči 12 ur, da bi preprečili občasne, nenadne konvulzije.
impotence
impotenca
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.
Gabapentin does not induce hepatic mixed function oxidase enzymes responsible for drug metabolism.
Gabapentin ne inducira jetrnih oksidaznih encimov mešane funkcije, odgovornih za presnovo zdravil.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER {Name and Address} <{tel}> <{fax}> <{e-mail}> [See Annex I - To be completed nationally]
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM {Ime in naslov} <{tel.}> <{faks}> <{e-pošta}> [Glejte Dodatek I - Izpolni država članica]
c 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).
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).
Sudden unexplained deaths have been reported where a causal relationship to treatment with gabapentin has not been established.
Poročali so o nenadnih nepričakovanih smrtih, vendar vzročna povezanost s terapijo z gabapentinom ni bila ugotovljena.
Regarding epilepsy, the indication as adjunctive therapy in children aged 3 years and above as well as the indication as monotherapy were debated.
V zvezi z epilepsijo so razpravljali o indikaciji dodatnega zdravljenja pri otrocih, starih 3 leta in več, ter o indikaciji monoterapije.
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.
No definite conclusion can be made as to whether gabapentin is associated with an increased risk of congenital malformations when taken during pregnancy, because of epilepsy itself and the presence of concomitant antiepileptic medicinal products during each reported pregnancy.
Ni mogoče zanesljivo sklepati, ali med nosečnostjo uporabljeni gabapentin predstavlja večje tveganje za prirojene malformacije zaradi same epilepsije in dejstva, da so bila med vsako nosečnostjo, o kateri so poročali, prisotna tudi druga antiepileptična zdravila.
Gabapentin is eliminated unchanged solely by renal excretion.
Gabapentin se eliminira nespremenjen, zgolj z izločanjem skozi ledvice.
Gabapentin can be given with or without food and should be swallowed whole with sufficient fluidintake (e.g. a glass of water).
Pogoltniti ga je treba celega in z zadostno količino tekočine (npr. s kozarcem vode).
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).
Dodatne post-hoc analize stopnje odziva po starosti niso pokazale statistično pomembnega učinka starosti niti za zvezno spremenljivko niti za dihotomno spremenljivko (starostni skupini 3-5 in 6-12 let).
No systematic studies in patients 65 years or older have been conducted with gabapentin.
Z gabapentinom niso izvedli sistematičnih študij pri bolnikih, starih 65 let ali več.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
There have been no studies specifically looking at the use of gabapentin in pregnant women, but other medications used to treat seizures have reported an increased risk of harm to the foetus, particularly when more than one seizure medication is taken at the same time.
Posebnih študij uporabe gabapentina pri nosečnicah ni bilo, vendar je za druga zdravila za zdravljenje epilepsije opisano, da povečujejo tveganje za škodljive učinke na plod, zlasti ob sočasnem jemanju več kot enega zdravila za zdravljenje epilepsije.
No significant issues relating to quality were identified and the pharmaceutical particulars of the product information were completed, except for the sections to be completed nationally.
Farmacevtski podatki v informacijah o zdravilu so bili dopolnjeni, razen poglavij, ki se izpolnijo na nacionalni ravni.
If your treatment is stopped it should be done gradually over a minimum of 1 week.
Če se zdravljenje konča, je treba odmerek zdravila zmanjševati postopoma, najmanj 1 teden.
In one double blind study in patients with neuropathic pain, somnolence, peripheral oedema and asthenia occurred in a somewhat higher percentage in patients aged 65 years or above, than in younger patients.
V eni dvojno slepi študiji bolnikov z nevropatskimi bolečinami so se pri bolnikih, starih 65 let ali več, somnolentnost, periferni edemi in astenija pojavili nekoliko pogosteje kot pri mlajših bolnikih.
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).
It is therefore recommended that [Neurontin and associated names] is taken at the earliest two hours after taking an antacid.
Zato je priporočljivo, da zdravilo [Neurontin in povezana imena] vzamete najmanj dve uri potem, ko ste vzeli antacid.
Gabapentin elimination-rate constant, plasma clearance, and renal clearance are directly proportional to creatinine clearance.
Konstanta hitrosti eliminacije, plazemski očistek in ledvični očistek gabapentina so neposredno sorazmerni očistku kreatinina.
In elderly patients, and in patients with impaired renal function, gabapentin plasma clearance is reduced.
Pri starejših bolnikih in bolnikih z okvarjenim delovanjem ledvic je plazemski očistek gabapentina manjši.
Gabapentin bioavailability (fraction of dose absorbed) tends to decrease with increasing dose.
Biološka uporabnost gabapentina (delež absorbiranega odmerka) se s povečevanjem odmerka zmanjšuje.
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.
Pfizer Oy, Tietokuja 4 00330 Helsinki Finland
Pfizer Oy, Tietokuja 4 00330 Helsinki Finska
For all indications a titration scheme for the initiation of therapy is described in Table 1, which is recommended for adults and adolescents aged 12 years and above.
Shema titriranja pri uvedbi terapije za vse indikacije je prikazana v tabeli 1; priporočena je za odrasle in mladostnike, stare 12 let in več.
Peripheral neuropathic pain: [Neurontin and associated names] is used to treat long lasting pain caused by damage to the nerves.
Periferne nevropatske bolečine: zdravilo [Neurontin in povezana imena] uporabljamo za zdravljenje dolgotrajnih bolečin, ki jih povzroči okvara živcev.
Where an adverse reaction was seen at different frequencies in clinical studies, it was assigned to the highest frequency reported.
Če se je pogostnost neželenega učinka med kliničnimi študijami razlikovala, je zabeležen pri največji opisani pogostnosti.
• Blood glucose fluctuations in patients with diabetes, abnormal blood test results suggesting problems with the liver.
• nihanje ravni glukoze v krvi pri diabetikih, nenormalni izvidi krvnih preiskav, ki kažejo na težave z jetri.
[Neurontin and associated names] belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain.
Zdravilo [Neurontin in povezana imena] sodi v skupino zdravil, ki jih uporabljamo za zdravljenje epilepsije in perifernih nevropatskih bolečin.
For anuric patients undergoing haemodialysis who have never received gabapentin, a loading dose of 300 to 400 mg, then 200 to 300 mg of gabapentin following each 4 hours of haemodialysis, is recommended.
Pri anuričnih bolnikih na hemodializi, ki niso še dobivali gabapentina, je priporočljiv polnilni odmerek od 300 do 400 mg in nato od 200 do 300 mg gabapentina po vsakih 4 urah hemodialize.
Signs of acute toxicity in animals included ataxia, laboured breathing, ptosis, hypoactivity, or excitation.
Med znaki akutne toksičnosti pri živalih so bile ataksija, težko dihanje, ptoza, hipoaktivnost ali vznemirjenost.
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 dopolnilnega zdravljenja parcialnih epileptičnih napadov pri pediatričnih preiskovancih, starih od 3 do 12 let, je pokazalo številsko, ne pa statistično značilne razlike pri 50odstotnem odzivu v prid skupine z gapabentinom v primerjavi s placebom.
AUC(0-8) = Steady state area under plasma concentration-time curve from time 0 to 8 hours postdose
AUC(0-8) = površina pod krivuljo koncentracije po času v stanju dinamičnega ravnovesja od 0 do 8 ur po odmerku
Gabapentin did not increase the incidence of malformations, compared to controls, in the offspring of mice, rats, or rabbits at doses up to 50, 30 and 25 times respectively, the daily human dose of 3600 mg, (four, five or eight times, respectively, the human daily dose on a mg/m2 basis).
Gabapentin v primerjavi s kontrolami ni povečal incidence malformacij pri potomstvu miši, podgan ali kuncev v do 50-, 30- in 25-kratnikih dnevnega odmerka 3600 mg pri človeku (kar je štirikratnik, petkratnik oz. osemkratnik dnevnega odmerka pri človeku na podlagi mg/m2).