natgillin/translations-raw huggingface dataset:
Acute, life-threatening toxicity has not been observed with gabapentin overdoses of up to 49 g.
Med prevelikim odmerjanjem gabapentina do 49 g niso opazili akutnih smrtno nevarnih toksičnih učinkov.
Symptoms of the overdoses included dizziness, double vision, slurred speech, drowsiness, lethargy and mild diarrhoea.
Med simptomi prevelikega odmerjanja so bili omotica, dvojen vid, nerazločno govorjenje, zaspanost, letargija in blaga driska.
Reduced absorption of gabapentin at higher doses may limit drug absorption at the time of overdosing and, hence, minimize toxicity from overdoses.
32 gabapentina ob velikih odmerkih lahko omeji absorpcijo v primeru prevelikega odmerjanja in tako minimizira toksične učinke prevelikih odmerkov.
An oral lethal dose of gabapentin was not identified in mice and rats given doses as high as 8000 mg/ kg.
Pri miših in podganah, ki so dobile velike odmerke do 8000 mg/ kg, niso ugotovili peroralnega smrtnega odmerka.
Other antiepileptics ATC code:
Farmakoterapevtska skupina: drugi antiepileptiki, oznaka ATC:
Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid) but its mechanism of action is different from that of several other active substances that interact with GABA synapses including valproate, barbiturates, benzodiazepines, GABA transaminase inhibitors, GABA uptake inhibitors, GABA agonists, and GABA prodrugs.
Gabapentin je po zgradbi soroden nevrotransmiterju GABA (gama- aminomaslena kislina), toda njegov mehanizem delovanja se razlikuje od mehanizma pri različnih drugih zdravilnih učinkovinah, ki vplivajo na sinapse GABA, vključno z valproatom, barbiturati, benzodiazepini, zaviralci GABA- transaminaze, zaviralci prevzema GABA, antagonisti GABA in predzdravili GABA.
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.
Gabapentin at relevant clinical concentrations does not bind to other common drug or neurotransmitter receptors of the brain including GABAA, GABAB, benzodiazepine, glutamate, glycine or N-methyl-d- aspartate receptors.
Gabapentin se v klinično pomembnih koncentracijah ne veže na druge pogoste možganske receptorje za zdravila ali nevrotransmiterje, vključno z receptorji za GABAA, GABAB, benzodiazepine, glutamat, glicin ali N- metil- d- aspartat.
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- D - aspartat (NMDA), vendar le v koncentracijah nad 100µM, ki pa in vivo niso dosežene.
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 50 - odstotnem odzivu v prid skupine z gapabentinom v primerjavi s placebom.
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 deležev odziva po starosti niso odkrile statistično značilnega vpliva starosti, ne kot zvezne ne kot dihotomne spremenljivke (za starostni skupini od 3 do 5 in od 6 do 12 let).
33 Response (≥ 50% Improved) by Treatment and Age MITT* Population
Odgovor (≥ 50% izboljšanje) glede na zdravljenje in starostno MITT * populacijo
Age Category
starostna kategorija
P-Value
P- vrednost
< 6 Years Old
< 6 let
4/ 17 (23.5%)
4/ 17 (23. 5%)
0.7362
0. 7362
6 to 12 Years Old
6 do 12 let
17/ 99 (17.2%)
17/ 99 (17. 2%)
20/ 96 (20.8%)
20/ 96 (20. 8%)
0.5144
0. 5144
*The modified intent to treat population was defined as all patients randomised to study medication who also had evaluable seizure diaries available for 28 days during both the baseline and double-blind phases.
33 * Modificirana populacija namenjena za zdravljenje je bila opredeljena kot populacija vseh tistih bolnikov, randomiziranih na raziskovano zdravilo, ki so za 28- dnevno izhodiščno in 28- dnevno dvojno slepo obdobje vodili dnevnik epileptičnih napadov, primernih za vrednotenje.
Absolute bioavailability of a 300 mg capsule is approximately 60%.
Absolutna biološka uporabnost 300- mg kapsule je približno 60%.
Pharmacokinetic parameters are given in Table 3.
Koncentracija gabapentina v plazmi je bila v kliničnih študijah na splošno med 2 µg/ ml in 20 µg/ ml, vendar takšne koncentracije niso napovedovale varnosti ali učinkovitosti zdravila.
Table 3 Summary of gabapentin mean (%CV) steady-state pharmacokinetic parameters following every eight hours administration
Farmakokinetične parametre prikazuje tabela 3.
Pharmacokinetic parameter
farmakokinetični
300 mg (N = 7)
300 mg (n = 7)
%CV
(n = 14)
Mean
(n = 14)
%CV
% KV
Mean
% KV
Cmax (µg/ ml) tmax (hr) T1/ 2 (hr) AUC (0-8) µg• hr/ ml)
Cmax (µg/ ml) tmax (ure) t1/ 2 (ure) AUC (0– 8) µg• ure/ ml)
NA NA
NP
Cmax = Maximum steady state plasma concentration tmax = Time for Cmax T1/ 2 = Elimination half-life AUC(0-8) = Steady state area under plasma concentration-time curve from time 0 to 8 hours postdose Ae% = Percent of dose excreted unchanged into the urine from time 0 to 8 hours postdose NA = Not available
Cmax = največja koncentracija v plazmi v stanju dinamičnega ravnovesja tmax = čas do Cmax t1/ 2 = eliminacijski razpolovni čas AUC( 0– 8) = površina pod krivuljo koncentracije po času v stanju dinamičnega ravnovesja od 0 do 8 ur po odmerku Ae% = odstotek odmerka, ki se je nespremenjen izločil v urinu od 0 do 8 ur po odmerku NP = ni podatka
Gabapentin is not bound to plasma proteins and has a volume of distribution equal to 57.7 litres.
Gabapentin ni vezan na beljakovine v plazmi in njegov volumen porazdelitve je 57, 7 litrov.
In patients with epilepsy, gabapentin concentrations in cerebrospinal fluid (CSF) are approximately 20% of
Pri bolnikih z epilepsijo je koncentracija gabapentina v cerebrospinalnem likvorju približno 20% ustrezne najmanjše plazemske koncentracije v stanju dinamičnega ravnovesja.
In elderly patients, and in patients with impaired renal function, gabapentin plasma clearance is reduced.
34 Pri starejših bolnikih in bolnikih z okvarjenim delovanjem ledvic je plazemski očistek gabapentina manjši.
Dosage adjustment in patients with compromised renal function or undergoing haemodialysis is recommended (see section 4.2).
Pri bolnikih z okrnjenim delovanjem ledvic in bolnikih na hemodializi je priporočljiva prilagoditev odmerka (glejte poglavje 4. 2).
In general, plasma gabapentin concentrations in children > 5 years of age are similar to those in adults when dosed on a mg/ kg basis.
Na splošno je bila koncentracija gabapentina v plazmi ob odmerjanju na podlagi mg/ kg pri otrocih, starejših od 5 let, podobna kot pri odraslih.
Linearity/ Non-linearity
Linearnost/ nelinearnost
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.
Biološka uporabnost gabapentina (delež absorbiranega odmerka) se s povečevanjem odmerka zmanjšuje, kar povzroči nelinearnost farmakokinetičnih parametrov, ki vključujejo parameter biološke uporabnosti (F), npr.
Elimination pharmacokinetics (pharmacokinetic parameters which do not include F such as CLr and T1/ 2), are best described by linear pharmacokinetics.
CLr in t1/ 2) najbolje opiše linearna farmakokinetika.
Gabapentin was given in the diet to mice at 200, 600, and 2000 mg/ kg/ day and to rats at 250, 1000, and 2000 mg/ kg/ day for two years.
Gabapentin so dve leti dajali mišim v odmerkih 200, 600 in 2000 mg/ kg/ dan in podganam v odmerkih 250, 1000 in 2000 mg/ kg/ dan.
Peak plasma drug concentrations in rats at 2000 mg/ kg/ day are 10 times higher than plasma concentrations in humans given 3600 mg/ day.
Ob odmerku 2000 mg/ kg/ dan je največja plazemska koncentracija zdravila pri podganah 10- krat večja kot plazemska koncentracija pri ljudeh, ki dobivajo 3600 mg/ dan.
No adverse effects on fertility or reproduction were observed in rats at doses up to 2000 mg/ kg (approximately five times the maximum daily human dose on a mg/ m2 of body surface area basis).
Pri podganah v odmerkih do 2000 mg/ kg (kar je glede na razmerje mg/ m2 telesne površine približno petkratnik največjega dnevnega odmerka pri človeku) niso zabeležili nobenih neželenih učinkov na plodnost ali reprodukcijo.
35 Teratogenesis
Teratogenost
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).
These effects occurred when pregnant mice received oral doses of 1000 or 3000 mg/ kg/ day during organogenesis and in rats given 500, 1000, or 2000 mg/ kg prior to and during mating and throughout gestation.
Ti učinki so se pojavili, ko so breje miši dobivale peroralne odmerke 1000 ali 3000 mg/ kg/ dan med organogenezo oz. podgane 500, 1000 ali 2000 mg/ kg pred parjenjem in med njim ter v času gestacije.
These doses are approximately 1 to 5 times the human dose of 3600 mg on a mg/ m2 basis.
Na podlagi mg/ m2 so ti odmerki približno 1 - do 5- krat tolikšni kot odmerek 3600 mg pri človeku.
No effects were observed in pregnant mice given 500 mg/ kg/ day (approximately 1/ 2 of the daily human dose on a mg/ m2 basis).
35 Nobenih učinkov niso opazili pri brejih miših, ki so dobivale 500 mg/ kg/ dan (kar je približno 1/ 2 dnevnega odmerka na podlagi mg/ m2).
An increased incidence of hydroureter and/ or hydronephrosis was observed in rats given 2000 mg/ kg/ day in a fertility and general reproduction study, 1500 mg/ kg/ day in a teratology study, and 500, 1000, and 2000 mg/ kg/ day in a perinatal and postnatal study.
Večjo incidenco hidroureterja in/ ali hidronefroze so opažali pri podganah, ki so dobivale 2000 mg/ kg/ dan v študiji plodnosti in splošne reprodukcije, 1500 mg/ kg/ dan v študiji teratogenosti ter 500, 1000 in 2000 mg/ kg/ dan v perinatalni in postnatalni študiji.
These doses are also approximately 1 to 5 times the human dose of 3600 mg on a mg/ m2 basis.
Tudi ti odmerki so na podlagi mg/ m2 približno 1 - do 5- krat tolikšni kot odmerek 3600 mg pri človeku.
In a teratology study in rabbits, an increased incidence of post-implantation fetal loss, occurred in doses given 60, 300, and 1500 mg/ kg/ day during organogenesis.
V študiji teratogenosti pri kuncih se je ob odmerkih 60, 300 in 1500 mg/ kg/ dan med organogenezo povečala incidenca poimplantacijskih izgub plodov.
These doses are approximately 1/ 4 to 8 times the daily human dose of 3600 mg on a mg/ m2 basis.
Na podlagi mg/ m2 so ti odmerki približno 1/ 4 - do 8- krat tolikšni kot dnevni odmerek 3600 mg pri človeku.
36 Also supplied as a titration pack for treatment of neuropathic pain containing 40 x 300 mg capsules and 10 x 600 mg tablets.
Za zdravljenje nevropatskih bolečin je na voljo tudi titracijsko pakiranje s 40 x 300 mg kapsulami in 10 x 600 mg tabletami.
37 LABELLING
37 OZNAČEVANJE
XX capsules or XX tablets
XX kapsul ali XX tablet
39 7.
39 Zdravilo shranjujte nedosegljivo otrokom!
{Name and Address }< {tel }> < {fax }> < {e-mail }>
{Ime in naslov} < {tel.} > < {faks} > < {e- pošta} >
41 PACKAGE LEAFLET
41 NAVODILO ZA UPORABO
42 PACKAGE LEAFLET:
42 NAVODILO ZA UPORABO
Neurontin and associated names 100 mg hard capsules Neurontin and associated names 300 mg hard capsules Neurontin and associated names 400 mg hard capsules Neurontin and associated names 600 mg film-coated tablets Neurontin and associated names 800 mg film-coated tablets [See Annex I - To be completed nationally] Gabapentin
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 [Glejte Dodatek I – Izpolni država članica] Gabapentin
You may need to read it again. − If you have any further questions, ask your doctor or pharmacist. − This medicine has been prescribed for you.
Morda ga boste želeli ponovno prebrati. − Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom. − Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
What [Neurontin and associated names] is and what it is used for 2.
Kaj je zdravilo [Neurontin in povezana imena] in za kaj ga uporabljamo 2.
Before you take [Neurontin and associated names] 3.
Kaj morate vedeti, preden boste vzeli zdravilo [Neurontin in povezana imena] 3.
How to take [Neurontin and associated names] 4.
Kako jemati zdravilo [Neurontin in povezana imena] 4.
How to store [Neurontin and associated names] 6.
Shranjevanje zdravila [Neurontin in povezana imena] 6.
WHAT [NEURONTIN AND ASSOCIATED NAMES] IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO [NEURONTIN IN POVEZANA IMENA] IN ZA KAJ GA UPORABLJAMO
[Neurontin and associated names] is used to treat various forms of epilepsy (seizures that are initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not).
Epilepsija: zdravilo [Neurontin in povezana imena] uporabljamo za zdravljenje različnih vrst epilepsije (napadov, ki so uvodoma omejeni na določene dele možganov, ne glede na to, ali se napad razširi na druge dele možganov ali ne).
[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.
A variety of different diseases can cause peripheral (primarily occurring in the legs and/ or arms) neuropathic pain, such as diabetes or shingles.
Periferne nevropatske bolečine (ki se pojavljajo predvsem v nogah in/ ali rokah) so lahko posledica najrazličnejših bolezni, npr. diabetesa in pasovca.
BEFORE YOU TAKE [NEURONTIN AND ASSOCIATED NAMES]
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO [NEURONTIN IN POVEZANA IMENA]
Do not take [Neurontin and associated names] − if you are allergic (hypersensitive) to gabapentin or any of the other ingredients of [Neurontin and associated names].
Ne uporabljajte zdravila [Neurontin in povezana imena] − če ste alergični na (preobčutljivi za) gabapentin ali katerokoli sestavino zdravila [Neurontin in povezana imena].
Take special care with [Neurontin and associated names] − if you suffer from kidney problems − if you develop signs such as persistent stomach pain, feeling sick and being sick contact your doctor immediately.
43 Bodite posebno pozorni pri jemanju zdravila [Neurontin in povezana imena] − če imate težave z ledvicami − če se vam pojavijo znaki, kot so vztrajna bolečina v trebuhu, slabo počutje in občutek slabosti, se morate nemudoma posvetovati z zdravnikom.
43 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jemanje drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Taking [Neurontin and associated names] with food and drink [Neurontin and associated names] can be taken with or without food.
Jemanje zdravila [Neurontin in povezana imena] skupaj s hrano in pijačo Zdravilo [Neurontin in povezana imena] lahko vzamete s hrano ali brez nje.
Driving and using machines [Neurontin and associated names] may produce dizziness, drowsiness and tiredness.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo [Neurontin in povezana imena] lahko povzroči omotico, zaspanost in utrujenost.
Important information about some of the ingredients of [Neurontin and associated names] The capsules contain lactose.
Pomembne informacije o nekaterih sestavinah zdravila [Neurontin in povezana imena]
HOW TO TAKE [NEURONTIN AND ASSOCIATED NAMES] 44 Always take [Neurontin and associated names] exactly as your doctor has told you.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
If you are an elderly patient (over 65 years of age), you should take [Neurontin and associated names] normally except if you have problems with your kidneys.
Če ste starejši (nad 65 let), jemljite zdravilo [Neurontin in povezana imena] normalno, razen če imate težave z ledvicami.
Your doctor may prescribe a different dosing schedule and/ or dose if you have problems with your kidneys.
Če imate težave z ledvicami, vam bo zdravnik morda predpisal drugačen program jemanja in/ ali odmerek zdravila.
The starting dose will generally be between 300 mg and 900 mg each day.
Začetni odmerek navadno znaša med 300 mg in 900 mg na dan.
Thereafter, the dose may be increased stepwise up to a maximum of 3600 mg each day and your doctor will tell you to take this in 3 divided doses, i. e. once in the morning, once in the afternoon and once in the evening.
Potem je mogoče odmerek postopoma povečati do največ 3600 mg na dan in vaš zdravnik vam bo naročil, da zdravilo jemljite v treh deljenih odmerkih, tj. enkrat zjutraj, enkrat popoldne in enkrat zvečer.
Take the number of capsules or tablets as instructed.
Vzemite toliko kapsul oz. tablet, kot vam je naročil zdravnik.
The dose to be given to your child will be decided by your doctor as it is calculated against your child’ s weight.
Odmerek, ki ga boste dajali otroku, bo določil zdravnik, ker ga je treba izračunati glede na otrokovo telesno maso.
The usual dose to control epilepsy is 25-35 mg/ kg/ day.
Običajen odmerek za obvladanje epilepsije je od 25 do 35 mg/ kg/ dan.
It is usually given in 3 divided doses, by taking the capsule(s) or tablet(s) each day, usually once in the morning, once in the afternoon and once in the evening.
Ponavadi se daje v 3 deljenih odmerkih z jemanjem kapsul( e) ali tablet( e) vsak dan, običajno enkrat zjutraj, enkrat popoldne in enkrat zvečer.
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 ste pozabili vzeti zdravilo [Neurontin in povezana imena]
Do not take a double dose to make up for a forgotten dose.
45 Če pozabite vzeti odmerek, ga vzemite, čim se spomnite, razen če ni že čas za naslednjega.
If you stop taking [Neurontin and associated names]
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
45 Do not stop taking [Neurontin and associated names] unless your doctor tells you to.
Če ste prenehali jemati zdravilo [Neurontin in povezana imena] Zdravila [Neurontin in povezana imena] ne nehajte jemati, razen če vam tega ne naroči zdravnik.
• Viral infection • Feeling drowsy, dizziness, lack of coordination • Feeling tired, fever
• virusna okužba • občutek zaspanosti, omotica, nekoordiniranost gibov • občutek utrujenosti, zvišana telesna temperatura
• Pneumonia, respiratory infection, urinary tract infection, infection, inflammation of the ear • Low white blood cell counts • Anorexia, increased appetite • Anger towards others, confusion, fluctuation in mood, depression, anxiety, nervousness, difficulty with thinking • Convulsions, jerky movements, difficulty with speaking, loss of memory, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation, difficulty with coordination, unusual eye movement, increased, decreased or absent reflexes • Blurred vision, double vision • Vertigo • High blood pressure, flushing or dilation of blood vessels • Difficulty breathing, bronchitis, sore throat, cough, dry nose • Vomiting (being sick), nausea (feeling sick), problems with teeth, inflamed gums, diarrhoea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence • Facial swelling, bruises, rash, itch, acne • Joint pain, muscle pain, back pain, twitching • Incontinence • Difficulties with erection • Swelling in the legs and arms or swelling that may involve the face, trunk and limbs, difficulty with walking, weakness, pain, feeling unwell, flu-like symptoms • Decrease in white blood cells, increase in weight • Accidental injury, fracture, abrasion
• pljučnica, okužba dihal, okužba sečil, okužba, vnetje ušesa • zmanjšanje števila belih krvnih celic • anoreksija, povečan apetit • jeza do drugih, zmedenost, nihanje razpoloženja, depresija, tesnobnost, živčnost, težave z razmišljanjem • konvulzije, trzajoči gibi, težave z govorom, poslabšanje spomina, tresenje, težave s spanjem, glavobol, občutljivost kože, slabše zaznavanje dotika, težave s koordinacijo, nenavadno premikanje očesnih zrkel, okrepljeni, oslabljeni ali odsotni refleksi • zamegljen vid, dvojen vid • vrtoglavica • visok krvni tlak, zardevanje ali razširitev žil • težko dihanje, bronhitis, bolečine v grlu, kašelj, suhost nosu • bruhanje, navzea (slabost s siljenjem na bruhanje), težave z zobmi, vnetje dlesni, driska, bolečine v želodcu, prebavne težave, zaprtje, suhost ust ali grla, vetrovi • otekanje obraza, podplutbe, izpuščaj, srbenje, akne • bolečine v sklepih, bolečine v mišicah, bolečine v hrbtu, trzanje • inkontinenca • težave z erekcijo • otekanje nog in rok ali otekanje obraza, trupa in okončin, težave pri hoji, šibkost, bolečina, slabo počutje, gripi podobni simptomi • zmanjšanje števila belih krvnih celic, zmanjšanje telesne mase • telesna poškodba, zlom, odrgnina
• Decreased platelets (blood clotting cells) • Allergic reaction such as hives • Hallucinations • Problems with abnormal movements such as writhing, jerking movements and stiffness • Ringing in the ears • Racing heartbeat • Inflammation of the pancreas • Inflammation of the liver, yellowing of the skin and eyes • Severe skin reactions that require immediate medical attention, swelling of the lips and face, skin rash and redness, hair loss • Acute kidney failure
• zmanjšano število trombocitov (krvnih ploščic, potrebnih za strjevanje krvi) • alergijska reakcija, npr. koprivnica • halucinacije • težave zaradi nenormalnih gibov, npr. zvijanje, trzanje in otrplost • zvonjenje v ušesih
46 • Adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain • Blood glucose fluctuations in patients with diabetes, abnormal blood test results suggesting problems with the liver.
46 • hiter srčni utrip • vnetje trebušne slinavke • vnetje jeter, porumenelost kože in oči • hude kožne reakcije, ki zahtevajo takojšnjo zdravniško oskrbo, otekanje ustnic in obraza, izpuščaj in pordelost kože, izpadanje las in dlak • akutna odpoved ledvic • neželeni učinki po nenadni prekinitvi zdravljenja z gabapentinom (tesnobnost, težave s spanjem, slabo počutje, bolečine, znojenje), bolečine v prsih • nihanje ravni glukoze v krvi pri diabetikih, nenormalni izvidi krvnih preiskav, ki kažejo na težave z jetri.
HOW TO STORE [NEURONTIN AND ASSOCIATED NAMES]
SHRANJEVANJE ZDRAVILA [NEURONTIN IN POVEZANA IMENA]
− The other ingredients in [Neurontin and associated names] tablets are:
− Pomožne snovi v tabletah [Neurontin in povezana imena] so:
What [Neurontin and associated names] looks like and contents of the pack
Izgled zdravila [Neurontin in povezana imena] in vsebina pakiranja
47
47 {Ime in naslov} < {tel.} > < {faks} > < {e- pošta} >
Czech Republic Neurontin Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Italy
Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: