FrancophonIA/ELRC3.0 huggingface dataset:
English: Driving and using machines [Neurontin and associated names] may produce dizziness, drowsiness and tiredness.
Slovenian: Zdravilo [Neurontin in povezana imena] lahko povzroči omotico, zaspanost in utrujenost.
English: Luxembourg Pfizer S.A.. Boulevard de la Plaine 17 B-1050
Slovenian: Luksemburg Pfizer S.A.. Boulevard de la Plaine 17 B-1050
English: Film-coated tablet [Description to be completed nationally]
Slovenian: Filmsko obložena tableta [Izpolni država članica]
English: Capsule, hard
Slovenian: Trde kapsule
English: − The other ingredients in [Neurontin and associated names] capsules are:
Slovenian: − Pomožne snovi v kapsulah [Neurontin in povezana imena] so:
English: Blood glucose fluctuations in patients with diabetes, elevated liver function tests Injury and poisoning
Slovenian: nihanje glukoze v krvi pri diabetikih, zvišani testi jetrne funkcije
English: Do not take [Neurontin and associated names]
Slovenian: Ne uporabljajte zdravila [Neurontin in povezana imena]
English: As with other antiepileptic medicinal products, some patients may experience an increase in seizure frequency or the onset of new types of seizures with gabapentin.
Slovenian: Tako kot z drugimi antiepileptičnimi zdravili lahko tudi med zdravljenjem z gabapentinom pri nekaterih bolnikih epileptični napadi postanejo pogostejši ali se pojavijo nove vrste teh napadov.
English: Gabapentin is excreted in human milk.
Slovenian: Gabapentin se izloča v materino mleko.
English: facial oedema, purpura most often described as bruises resulting from physical trauma, rash, pruritus, acne
Slovenian: edem obraza, purpura, najpogosteje opisana kot podplutbe zaradi telesne poškodbe, izpuščaj, srbenje, akne
English: Teratogenesis
Slovenian: Teratogenost
English: − This medicine has been prescribed for you.
Slovenian: − Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: There is no evidence of gabapentin metabolism in humans.
Slovenian: Ni dokazov, da bi se gabapentin pri človeku presnavljal.
English: Very common side-effects which may affect more than 1 person in 10 are listed below:
Slovenian: Spodaj so našteti zelo pogosti neželeni učinki, ki se lahko pojavijo pri več kot 1 od 10 oseb:
English: Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles etc.
Slovenian: Občutek pri teh bolečinah je mogoče opisati kot vroč, pekoč, kljuvajoč, rezek, zbadajoč, oster, krčevit, boleč, gomazeč, omrtvel, mravljinčast itn.
English: Gabapentin is removed from plasma by haemodialysis.
Slovenian: Hemodializa odstrani gabapentin iz plazme.
English: 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.
Slovenian: V študiji teratogenosti pri kuncih se je ob odmerkih 60, 300 in 1500 mg/kg/dan med organogenezo povečala incidenca poimplantacijskih izgub plodov.
English: 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.
Slovenian: Ženske, za katere je verjetno, da bodo zanosile, in ženske v rodni dobi se morajo posvetovati s specialistom.
English: Treatment of peripheral neuropathic pain
Slovenian: Zdravljenje periferne nevropatske bolečine
English: Impairment of Fertility
Slovenian: Okvara plodnosti
English: • 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
Slovenian: • otekanje nog in rok ali otekanje obraza, trupa in okončin, težave pri hoji, šibkost, bolečina, slabo počutje, gripi podobni simptomi
English: PFIZER HELLAS 243 Messoghion Ave., Neo Psychiko 154 51 Greece
Slovenian: PFIZER HELLAS 243 Messoghion Ave., Neo Psychiko 154 51 Grčija
English: Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking [Neurontin and associated names].
Slovenian: Če med jemanjem zdravila [Neurontin in povezana imena] zanosite, domnevate, da ste zanosili, ali načrtujete nosečnost, se morate nemudoma posvetovati z zdravnikom.
English: peripheral or generalized oedema, abnormal gait, asthenia, pain, malaise, flu syndrome
Slovenian: periferni ali generalizirani edemi, nenormalna hoja, astenija, bolečine, splošno slabo počutje, gripozni sindrom
English: Following oral administration, peak plasma gabapentin concentrations are observed within 2 to 3 hours.
Slovenian: Gabapentin doseže največjo koncentracijo v plazmi od 2 do 3 ure po peroralni uporabi.
English: Additionally in clinical studies in children, aggressive behaviour and jerky movements were reported commonly.
Slovenian: Dodatno so v kliničnih raziskavah pri otrocih pogosto poročali o agresivnem vedenju in trzajočih gibih.
English: Pfizer Hellas A.E. 243, Messoghion Ave., Neo Psychiko 154 51 Greece
Slovenian: Pfizer Hellas A.E. 243, Messoghion Ave., Neo Psychiko 154 51 Grčija
English: Elderly patients may require dosage adjustment because of declining renal function with age (see Table 2).
Slovenian: Delovanje ledvic s starostjo peša, zato utegne biti pri starejših bolnikih potrebna prilagoditev odmerka (glejte tabelo 2).
English: vomiting, nausea, dental abnormalities, gingivitis, diarrhea, abdominal pain, dyspepsia, constipation, dry mouth or throat, flatulence
Slovenian: bruhanje, navzea, zobne nenormalnosti, gingivitis, driska, bolečine v trebuhu, dispepsija, zaprtje, suhost ust ali žrela, flatulenca
English: • Accidental injury, fracture, abrasion
Slovenian: • telesna poškodba, zlom, odrgnina
English: accidental injury, fracture, abrasion
Slovenian: telesna poškodba, zlom, abrazija
English: You should take [Neurontin and associated names] in addition to your current treatment unless told otherwise.
Slovenian: Zdravilo [Neurontin in povezana imena] morate jemati poleg trenutno uporabljanih zdravil, razen če vam zdravnik naroči drugače.
English: It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin therapy.
Slovenian: Za optimizacijo zdravljenja z gabapentinom ni treba kontrolirati njegove koncentracije v plazmi.
English: However, in patients with severe renal impairment, haemodialysis may be indicated.
Slovenian: Hemodializa pa je lahko indicirana pri bolnikih s hudo okvaro ledvic.
English: palpitations
Slovenian: palpitacije
English: Neurontin and associated names 600 mg film-coated tablet Neurontin and associated names 800 mg film-coated tablet
Slovenian: Neurontin in povezana imena 600 mg filmsko obložene tablete Neurontin in povezana imena 800 mg filmsko obložene tablete
English: allergic reactions (e.g. urticaria) Metabolism and Nutrition Disorders Common:
Slovenian: alergijske reakcije (npr. urtikarija)
English: Somnolence, peripheral oedema and asthenia may be more frequent in elderly patients.
Slovenian: Pri starejših bolnikih se lahko bolj pogosto pojavljajo somnolentnost, periferni edemi in astenija.
English: Each capsule, hard contains either 100 mg, 300 mg or 400 mg gabapentin.
Slovenian: Ena trda kapsula vsebuje 100 mg, 300 mg ali 400 mg gabapentina.
English: These doses are also approximately 1 to 5 times the human dose of 3600 mg on a mg/m2 basis.
Slovenian: Tudi ti odmerki so na podlagi mg/m2 približno 1- do 5-krat tolikšni kot odmerek 3600 mg pri človeku.
English: Do not stop taking [Neurontin and associated names] unless your doctor tells you to.
Slovenian: Če ste prenehali jemati zdravilo [Neurontin in povezana imena] Zdravila [Neurontin in povezana imena] ne nehajte jemati, razen če vam tega ne naroči zdravnik.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg hard capsule contains 100 mg of gabapentin.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena 100 mg trda kapsula vsebuje 100 mg gabapentina.
English: visual disturbances such as amblyopia, diplopia Ear and Labyrinth disorders Common:
Slovenian: motnje vida, npr. ambliopija, diplopija Ušesne bolezni, vključno z motnjami labirinta Pogosti:
English: Renal excretion of gabapentin is unaltered by probenecid.
Slovenian: Probenecid ne spremeni ledvičnega izločanja gabapentina.
English: Infections and infestations Very Common: Viral infection Common:
Slovenian: Infekcijske in parazitske bolezni Zelo pogosti:
English: Dosages up to 4800 mg/day have been well tolerated in long-term open-label clinical studies.
Slovenian: V dolgotrajnih odprtih kliničnih študijah so bolniki dobro prenašali odmerke do 4800 mg/dan.
English: BATCH NUMBER [To be completed nationally]
Slovenian: ŠTEVILKA SERIJE [Izpolni država članica]
English: thrombocytopenia Immune system disorders Rare:
Slovenian: Bolezni imunskega sistema Redki:
English: 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).
Slovenian: 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).
English: HOW TO TAKE [NEURONTIN AND ASSOCIATED NAMES]
Slovenian: KAKO JEMATI ZDRAVILO [NEURONTIN IN POVEZANA IMENA]
English: As with other anti-epileptics, attempts to withdraw concomitant anti-epileptics in treatment refractory patients on more than one anti-epileptic, in order to reach gabapentin monotherapy have a low success rate.
Slovenian: Poskusi prekinitve zdravljenja s sočasnimi antiepileptiki pri bolnikih, neodzivnih na več kot en antiepiletpik, z namenom uvesti monoterapijo z gabapentinom, so bili tako kot pri drugih antiepileptikih le malokrat uspešni.
English: A slight decrease in renal excretion of gabapentin that is observed when it is coadministered with cimetidine is not expected to be of clinical importance.
Slovenian: Med sočasno uporabo gabapentina in cimetidina se ledvično izločanje gabapentina rahlo zmanjša, vendar ni pričakovati, da bi bilo to klinično pomembno.
English: If you stop taking [Neurontin and associated names]
Slovenian: Če ste pozabili vzeti zdravilo [Neurontin in povezana imena]
English: Each 800 mg film-coated tablet contains 800 mg of gabapentin.
Slovenian: Ena 800 mg filmsko obložena tableta vsebuje 800 mg gabapentina.
English: Each film-coated tablet contains either 600 mg or 800 mg gabapentin.
Slovenian: Ena filmsko obložena tableta vsebuje 600 mg ali 800 mg gabapentina.
English: Gabapentin pharmacokinetics are not affected by repeated administration.
Slovenian: Večkratna aplikacija ne vpliva na farmakokinetiko gabapentina.
English: Common side-effects which may affect more than 1 person in 100 are listed below:
Slovenian: Spodaj so našteti pogosti neželeni učinki, ki se lahko pojavijo pri več kot 1 od 100 oseb:
English: Take special care with [Neurontin and associated names]
Slovenian: Bodite posebno pozorni pri jemanju zdravila [Neurontin in povezana imena]
English: dyspnoea, bronchitis, pharyngitis, cough, rhinitis Gastrointestinal disorders Common:
Slovenian: dispneja, bronhitis, faringitis, kašelj, rinitis
English: hypertension, vasodilatation Respiratory, thoracic and mediastinal disorders Common:
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti:
English: Each 300 mg hard capsule contains 300 mg of gabapentin.
Slovenian: Ena 300 mg trda kapsula vsebuje 300 mg gabapentina.
English: Each 400 mg hard capsule contains 400 mg of gabapentin.
Slovenian: Ena 400 mg trda kapsula vsebuje 400 mg gabapentina.
English: Each 600 mg film-coated tablet contains 600 mg of gabapentin.
Slovenian: Ena 600 mg filmsko obložena tableta vsebuje 600 mg gabapentina.
English: 400 mg Capsules, hard
Slovenian: 400 mg Trde kapsule
English: Neurontin and associated names 100 mg hard capsule
Slovenian: Neurontin in povezana imena 100 mg trde kapsule
English: Peripheral Neuropathic Pain:
Slovenian: Periferne nevropatske bolečine:
English: Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys.
Slovenian: Če imate težave z ledvicami, vam bo zdravnik morda predpisal drugačen program jemanja in/ali odmerek zdravila.
English: Neurontin and associated names 300 mg hard capsule
Slovenian: Neurontin in povezana imena 300 mg trde kapsule
English: These doses are approximately 1/4 to 8 times the daily human dose of 3600 mg on a mg/m2 basis.
Slovenian: Na podlagi mg/m2 so ti odmerki približno 1/4- do 8-krat tolikšni kot dnevni odmerek 3600 mg pri človeku.
English: • Adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain
Slovenian: • neželeni učinki po nenadni prekinitvi zdravljenja z gabapentinom (tesnobnost, težave s spanjem,
English: 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
Slovenian: 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
English: Each 100 mg hard capsule contains 13 mg lactose (as monohydrate).
Slovenian: Ena 100 mg trda kapsula vsebuje 13 mg laktoze v obliki monohidrata.
English: Neurontin and associated names 400 mg hard capsule
Slovenian: Neurontin in povezana imena 400 mg trde kapsule
English: Finally, in children, aggressive behaviour and hyperkinesias were reported commonly.
Slovenian: Ravno tako pri otrocih pogosto opažajo napadalno vedenje in hiperkinezije.
English: Each 400 mg hard capsule contains 54 mg lactose (as monohydrate).
Slovenian: Ena 400 mg trda kapsula vsebuje 54 mg laktoze v obliki monohidrata.
English: Dosages up to 50 mg/kg/day have been well tolerated in a longterm clinical study.
Slovenian: V dolgotrajni klinični študiji so bolniki dobro prenašali odmerke do 50 mg/kg/dan.
English: Somnolence, peripheral oedema and asthenia may be more frequent in the elderly.
Slovenian: Somnolenco, periferni edem in astenijo so pogosteje opazili pri starostnikih.
English: 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 Gabapentin [See Annex I - To be completed nationally]
Slovenian: 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 Gabapentin [Glejte Dodatek I - Izpolni država članica]
English: Dosage adjustment is recommended in patients with compromised renal function as described in Table 2 and/or those undergoing haemodialysis.
Slovenian: Pri bolnikih z okvarjenim delovanjem ledvic in/ali na hemodializi je priporočljivo prilagoditi odmerek, kot prikazuje tabela 2.
English: 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.
Slovenian: 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.
English: Each 300 mg hard capsule contains 41 mg lactose (as monohydrate).
Slovenian: Ena 300 mg trda kapsula vsebuje 41 mg laktoze v obliki monohidrata.
English: 300 mg Capsules, hard
Slovenian: 300 mg Trde kapsule
English: The therapeutic indication of gabapentin as adjunctive epilepsy therapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above is well established.
Slovenian: Dobro uveljavljena terapevtska indikacija za gabapentin je dodatno zdravljenje epilepsije pri zdravljenju parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih in otrocih, starih 12 let ali več.
English: Grounds for amendments of the Summaries of Products Characteristics, labelling and Package leaflet
Slovenian: Podlaga za dopolnilo Povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo
English: Peripheral neuropathic pain
Slovenian: Periferne nevropatske bolečine
English: • Joint pain, muscle pain, back pain, twitching
Slovenian: • bolečine v sklepih, bolečine v mišicah, bolečine v hrbtu, trzanje
English: These doses are approximately 1 to 5 times the human dose of 3600 mg on a mg/m2 basis.
Slovenian: Na podlagi mg/m2 so ti odmerki približno 1- do 5-krat tolikšni kot odmerek 3600 mg pri človeku.
English: Neurontin 800 mg Film-coated tablets
Slovenian: Neurontin 800 mg Filmsko obložene tablete Peroralna uporaba
English: 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.
Slovenian: Zdravljenje je mogoče začeti s titriranjem odmerka, kot prikazuje tabela 1, ali z uporabo 300 mg trikrat na dan 1. dan. 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.
English: • 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
Slovenian: glavobol, občutljivost kože, slabše zaznavanje dotika, težave s koordinacijo, nenavadno premikanje očesnih zrkel, okrepljeni, oslabljeni ali odsotni refleksi
English: [Neurontin and associated names] may interfere with some laboratory tests, if you require a urine test tell your doctor or hospital that you are taking [Neurontin and associated names].
Slovenian: Če morate opraviti pregled urina, zdravniku ali v bolnišnici povejte, da jemljete zdravilo [Neurontin in povezana imena].
English: Neurontin 600 mg Film-coated tablets
Slovenian: Neurontin 600 mg Filmsko obložene tablete Peroralna uporaba
English: − The other ingredients in [Neurontin and associated names] tablets are:
Slovenian: − Pomožne snovi v tabletah [Neurontin in povezana imena] so: [Izpolni država članica]
English: 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).
Slovenian: 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.
English: What [Neurontin and associated names] looks like and contents of the pack
Slovenian: Izgled zdravila [Neurontin in povezana imena] in vsebina pakiranja Trda kapsula
English: 800 mg Film-coated tablets
Slovenian: 800 mg Filmsko obložene tablete
English: 600 mg Film-coated tablets
Slovenian: 600 mg Filmsko obložene tablete
English: − Keep this leaflet.
Slovenian: PRETISNI OMOT
English: Mean %CV Mean %CV Mean %CV
Slovenian: 800 mg (n = 14) povprečje % KV povprečje % KV povprečje % KV
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities
Slovenian: 6.4 Posebna navodila za shranjevanje [Izpolni država članica]
English: Acute, life-threatening toxicity has not been observed with gabapentin overdoses of up to 49 g. Symptoms of the overdoses included dizziness, double vision, slurred speech, drowsiness, lethargy and mild diarrhoea.
Slovenian: Med simptomi prevelikega odmerjanja so bili omotica, dvojen vid, nerazločno govorjenje, zaspanost, letargija in blaga driska.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 100 mg hard capsule contains 100 mg of gabapentin.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena 100 mg trda kapsula vsebuje 100 mg gabapentina.
English: An oral lethal dose of gabapentin was not identified in mice and rats given doses as high as 8000 mg/kg.
Slovenian: Pri miših in podganah, ki so dobile velike odmerke do 8000 mg/kg, niso ugotovili peroralnega smrtnega odmerka.
English: anorexia, increased appetite Psychiatric disorders Common:
Slovenian: anoreksija, povečan apetit
English: Always take [Neurontin and associated names] exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila [Neurontin in povezana imena] natančno upoštevajte zdravnikova navodila.
English: leucopenia
Slovenian: levkopenija
English: General disorders and administration site conditions Very Common: fatigue, fever Common:
Slovenian: Splošne težave in spremembe na mestu aplikacije Zelo pogosti:
English: 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.
Slovenian: Tveganje za prirojene malformacije je lahko med zdravljenjem z več antiepileptičnimi zdravili večje kot med monoterapijo.
English: Pneumonia, respiratory infection, urinary tract infection, infection, otitis media Blood and the lymphatic system disorders Common:
Slovenian: pljučnica, okužba dihal, okužba sečil, okužba, otitis media
English: What [Neurontin and associated names] contains
Slovenian: Kaj vsebuje zdravilo [Neurontin in povezana imena]
English: • Inflammation of the pancreas
Slovenian: • vnetje trebušne slinavke
English: Gabapentin 100 mg capsules can be used to follow dosing recommendations for patients with renal insufficiency.
Slovenian: Da bi bolniki z ledvično insuficienco lahko upoštevali priporočeno odmerjanje, naj uporabljajo 100 mg kapsule gabapentin.
English: HOW TO STORE [NEURONTIN AND ASSOCIATED NAMES] Keep out of the reach and sight of children.
Slovenian: SHRANJEVANJE ZDRAVILA [NEURONTIN IN POVEZANA IMENA] Zdravilo shranjujte nedosegljivo otrokom!
English: Marketing Authorisation Holder and Manufacturer
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec [Izpolni država članica]
English: • Vomiting (being sick), nausea (feeling sick), problems with teeth, inflamed gums, diarrhoea,
Slovenian: • bruhanje, navzea (slabost s siljenjem na bruhanje), težave z zobmi, vnetje dlesni, driska, bolečine v želodcu, prebavne težave, zaprtje, suhost ust ali grla, vetrovi
English: No special requirements.
Slovenian: Ni bilo odkritih pomembnih zadržkov, ki se nanašajo na kakovost.
English: Neurontin
Slovenian: NP
English: International non-proprietary name (INN): spiramycin
Slovenian: Mednarodno nelastniško ime (INN): spiramicin
English: The final opinion was converted into a Decision by the European Commission on 11 December 2014.
Slovenian: Končno mnenje je bilo 11. decembra 2014 spremenjeno v sklep Evropske komisije.
English: Oral explanations were given on 9 September 2014.
Slovenian: Ustna pojasnila so bila podana 9. septembra 2014.
English: Written explanations were provided by the applicants and marketing authorisation holders on 10 December 2012, 14 October 2013, 1 April 2014 and 10 June 2014.
Slovenian: Predlagatelji in imetniki dovoljenja za promet z zdravili so pisna pojasnila predložili 10. decembra 2012, 14. oktobra 2013, 1. aprila 2014 in 10. junija 2014.
English: The Committee appointed C. Ibrahim as rapporteur and B. Urbain as co-rapporteur.
Slovenian: Odbor je imenoval Cornelio Ibrahim za poročevalko in Bruna Urbaina za soporočevalca.
English: The referral started on 13 September 2012.
Slovenian: Napotitveni postopek se je začel 13. septembra 2012.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.
Slovenian: Seznam zadevnih imen zdravil je naveden v Prilogi I. Znanstveni zaključki so navedeni v Prilogi II, skupaj s spremembami povzetkov glavnih značilnosti zdravila, označevanja in navodila za uporabo v Prilogi III.