FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - WITHOUT BLUE BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI MULTIPAKIRANJE - BREZ PODATKOV ZA »MODRO OKENCE«
English: HDPE container with PP screw cap.
Slovenian: Vsebnik HDPE z navojnim pokrovčkom PP navojnim zamaškom.
English: • Weakness, thirst, chest tightness.
Slovenian: • Šibkost, žeja, tiščanje v prsih.
English: After stopping long and short-term Pregabalin Sandoz treatment, you need to know that you may experience certain side effects.
Slovenian: Po koncu dolgoročnega ali kratkoročnega zdravljenja z zdravilom Pregabalin Sandoz se lahko pri vas pojavijo določeni neželeni učinki.
English: 42 x 1 hard capsules.
Slovenian: 42 x 1 trda kapsula.
English: Withdrawal of concomitant antiepileptic medicinal products There are insufficient data for the withdrawal of concomitant anti-epileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached, in order to reach monotherapy on pregabalin.
Slovenian: Ukinitev sočasno uporabljenih antiepileptičnih zdravil Ni zadostnih podatkov za ukinitev sočasno uporabljenih antiepileptičnih zdravil in prehod na monoterapijo s pregabalinom, ko je pri dodatnem zdravljenju s pregabalinom dosežen nadzor nad napadi.
English: 42 hard capsules.
Slovenian: 42 trdih kapsul.
English: The pregabalin safety profile observed in three paediatric studies in patients with partial seizures with or without secondary generalization (12-week efficacy and safety study in patients with partial onset seizures, n=295; pharmacokinetic and tolerability study, n=65; and 1 year open label follow on safety study, n=54) was similar to that observed in the adult studies of patients with epilepsy.
Slovenian: Varnostni profil pregabalina, opažen v treh študijah pri otrocih s parcialnimi napadi s sekundarno generalizacijo ali brez nje (12-tedenska študija o učinkovitosti in varnosti pri bolnikih s parcialnimi napadi, n=295; študija farmakokinetike in prenašanja zdravila, n = 65; in enoletna odprta nadaljevalna študija varnosti, n = 54), je bil podoben tistemu v študijah pri odraslih z epilepsijo.
English: If at any time you have these thoughts, immediately contact your doctor.
Slovenian: Če kadarkoli začnete razmišljati o tem, se nemudoma posvetujte s svojim zdravnikom.
English: Container packs: 100, 200 or 250 hard capsules
Slovenian: Pakiranje vsebnika: 100, 200 ali 250 trdih kapsul.
English: Container packs: 200 hard capsules
Slovenian: Pakiranje vsebnika: 200 trdih kapsul.
English: • Breast discharge, abnormal breast growth, breast growth in males.
Slovenian: • Izcedek iz dojk, nenormalna rast dojk, rast tkiva dojk pri moških.
English: 50 x 1 hard capsules.
Slovenian: 50 x 1 trda kapsula.
English: In controlled clinical trials (4-8 week duration) 52% of the pregabalin treated patients and 38% of the patients on placebo had at least a 50% improvement in HAM-A total score from baseline to endpoint.
Slovenian: V kontroliranih kliničnih preskušanjih (ki so trajala od 4 do 8 tednov) se je od začetka do končnega cilja preskušanja skupna ocena HAM-A izboljšala za najmanj 50 % pri 52 % bolnikov, ki so prejemali pregabalin, in pri 38 % bolnikov, ki so prejemali placebo.
English: Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
Slovenian: Imetnik dovoljenja za promet z zdravilom Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Avstrija
English: Pregabalin Sandoz is for oral use only.
Slovenian: Zdravilo Pregabalin Sandoz je samo za peroralno uporabo.
English: variations.nordic@sandoz.com
Slovenian: office.cz@sandoz.com
English: 70 x 1 hard capsules.
Slovenian: 70 x 1 trda kapsula.
English: Pregabalin Sandoz belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.
Slovenian: Zdravilo Pregabalin Sandoz sodi med zdravila, ki se uporabljajo za zdravljenje epilepsije, nevropatske bolečine in generalizirane anksiozne motnje pri odraslih.
English: Do not stop taking Pregabalin Sandoz unless your doctor tells you to.
Slovenian: Če ste prenehali jemati zdravilo Pregabalin Sandoz Ne prenehajte jemati zdravila Pregabalin Sandoz, razen če vam to naroči zdravnik.
English: • Difficulty breathing, dry nose, nasal congestion.
Slovenian: • Oteženo dihanje, suhost nosu, zamašen nos.
English: • Flushing, hot flushes.
Slovenian: • Pordevanje, vročinski oblivi.
English: Pregabalin has been studied in 3 controlled clinical trials of 12 week duration with BID or TID dosing.
Slovenian: Pregabalin so preučevali v 3 kontroliranih kliničnih preskušanjih v trajanju 12 tednov z odmerjanjem 2-krat in 3-krat na dan.
English: If you experience a convulsion, contact your doctor immediately.
Slovenian: Če imate krče, to takoj sporočite svojemu zdravniku.
English: Generalised anxiety disorder Pregabalin Sandoz is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Slovenian: Zdravilo Pregabalin Sandoz je indicirano za zdravljenje generalizirane anksiozne motnje (GADGeneralised Anxiety Disorder) pri odraslih.
English: • Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal.
Slovenian: • Motnje pozornosti, nerodnost, okvara spomina, izguba spomina, tresenje, težave pri govorjenju, mravljinčenje, otrplost, sedacija, stanje podobno globokemu spanju (letargija), nespečnost, utrujenost, nenormalno počutje.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 300 mg hard capsules pregabalin NAME OF THE MARKETING AUTHORISATION HOLDER Sandoz EXPIRY DATE
Slovenian: IME ZDRAVILA Pregabalin Sandoz 300 mg trde kapsule pregabalin IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sandoz DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Unit dose blisters containing 84 x 1 hard capsules.
Slovenian: Pretisni omoti s posameznimi odmerki, ki vsebujejo 84 x 1 trdo kapsulo.
English: The following reactions have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, convulsions, nervousness, depression, pain, hyperhidrosis and dizziness, suggestive of physical dependence.
Slovenian: Opisani so naslednji odzivi: nespečnost, glavobol, navzea, anksioznost, driska, gripozni sindrom, krči, živčnost, depresija, bolečine, hiperhidroza in omotica; le-ti kažejo na fizično odvisnost.
English: • Sore throat.
Slovenian: • Vneto žrelo.
English: How to store Pregabalin Sandoz
Slovenian: Shranjevanje zdravila Pregabalin Sandoz
English: Unit dose blisters containing 56 x 1, 84 x 1 or 100 x 1 hard capsules.
Slovenian: Pretisni omoti s posameznimi odmerki, ki vsebujejo 56 x 1, 84 x 1 ali 100 x 1 trdo kapsulo.
English: 150 mg capsules:
Slovenian: 150 mg kapsule:
English: A meta- analysis of randomised placebo controlled studies of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
Slovenian: Majhno povečanje tveganja za pojav samomorilnega razmišljanja in vedenja je pokazala tudi metaanaliza randomiziranih, s placebom nadzorovanih kliničnih študij antiepileptikov.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Sandoz
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sandoz GmbH
English: Adjunctive Treatment
Slovenian: Epilepsija Dodatno zdravljenje
English: Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172)
Slovenian: Ovojnica kapsule želatina titanov dioksid (E171) rumen železov oksid (E172) rdeč železov oksid (E172) črn železov oksid (E172)
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Slovenian: EDINSTVENA OZNAKA -DVODIMENZIONALNA ČRTNA KODA <Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.> 18.
English: Blisters containing 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) or 120 (2 x 60) hard capsules.
Slovenian: Pretisni omoti, ki vsebujejo 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) ali 120 (2 x 60) trdih kapsul.
English: • Hypersensitivity, swollen face, itchiness, hives, runny nose, nose bleed, cough, snoring.
Slovenian: • Preobčutljivost, oteklost obraza, srbenje, koprivnica, izcedek iz nosu, krvavitve iz nosu, kašelj, smrčanje.
English: 75 mg capsules:
Slovenian: 75 mg kapsule:
English: What Pregabalin Sandoz looks like and contents of the pack 25 mg capsules Pale yellow-brown opaque cap and body, capsule size 4 (14.3 mm x 5.3 mm) filled with white to nearly white coloured powder.
Slovenian: Izgled zdravila Pregabalin Sandoz in vsebina pakiranja 25 mg kapsule Neprozorna pokrovček in telo blede rumenkasto-rjave barve, velikost kapsule 4 (14,3 mm x 5,3 mm), napolnjena s praškom bele do belkaste barve.
English: 225 mg capsules: Blisters containing 14, 56, 70, 84,100 or 120 hard capsules.
Slovenian: 225 mg kapsule: Pretisni omoti, ki vsebujejo 14, 56, 70, 84, 100 or 120 trdih kapsul.
English: EE-11312 Tallinn Tel.: +372 665 2400 Info.ee@sandoz.com
Slovenian: Tel.: +372 665 2400 Info.ee@sandoz.com
English: Ascites, pancreatitis, swollen tongue, dysphagia
Slovenian: Redki ascites, pankreatitis, oteklost jezika, disfagija
English: Unit dose blisters containing 56, 84 (2 x 42), 100 (2 x 50) or 210 (3 x 70) hard capsules.
Slovenian: Pretisni omoti s posameznimi odmerki, ki vsebujejo 56, 84 (2 x 42), 100 (2 x 50) ali 210 (3 x 70) trdih kapsul.
English: • Increased fluid in the abdomen.
Slovenian: • Nabiranje tekočine v trebušni votlini.
English: How to take Pregabalin Sandoz
Slovenian: Kako jemati zdravilo Pregabalin Sandoz
English: Vomiting, nausea, constipation, diarrhoea, flatulence, abdominal distension, dry mouth
Slovenian: Pogosti bruhanje, navzea, zaprtje, diareja, flatulenca, napetost trebušne stene, suha usta
English: Results of a 12-week placebo-controlled study of 295 paediatric patients aged 4 to 16 years performed to evaluate the efficacy and safety of pregabalin as adjunctive therapy for the treatment of partial onset seizures and a 1 year open label safety study in 54 paediatric patients from 3 months to 16 years of age with epilepsy indicate that the adverse events of pyrexia and upper respiratory infections were observed more frequently than in adult studies of patients with epilepsy (see sections 4.2, 4.8 and 5.2).
Slovenian: Rezultati 12-tedenske s placebom nadzorovane študije pri 295 pediatričnih bolnikih, starih od 4 do 16 let, ki so jo izvedli za ovrednotenje učinkovitosti in varnosti pregabalina kot dodatne terapije za zdravljenje parcialnih napadov in enoletne odprte študije varnosti pri 54 pediatričnih bolnikih z epilepsijo, starih od 3 mesecev do 16 let, kažejo, da so opazili neželene učinke - pireksijo in okužbe zgornjih dihal - pogosteje kot v študijah pri odraslih bolnikih z epilepsijo (glejte poglavja 4.2, 4.8 in 5.2).
English: Unit dose blisters containing 84 or 100 hard capsules.
Slovenian: Pretisni omoti s posameznimi odmerki, ki vsebujejo 84 ali 100 trdih kapsul.
English: Pregabalin Sandoz may produce dizziness, sleepiness and decreased concentration.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Pregabalin Sandoz lahko povzroči omotico, zaspanost in poslabša sposobnost koncentracije.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA ZA PRETISNE OMOTE
English: 25 mg capsules:
Slovenian: 25 mg kapsule:
English: 200 mg capsules:
Slovenian: 200 mg kapsule:
English: 300 mg capsules:
Slovenian: 300 mg kapsule:
English: 100 mg capsules:
Slovenian: 100 mg kapsule:
English: Dose regimen
Slovenian: PRETISNI OMOTI
English: • Dry eyes, eye swelling, eye pain, weak eyes, watery eyes, eye irritation.
Slovenian: • Suhe oči, otekanje oči, bolečine v očeh, zmanjšanje ostrine vida, solzenje, draženje oči.
English: • Changes in eyesight, unusual eye movement, changes in vision including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness on standing, sensitive skin,
Slovenian: • Spremembe vida, nenavadni gibi oči, spremembe vida (vključno z izgubo obrobnega vida), bliski svetlobe, trzanje, zmanjšanje refleksov, čezmerna dejavnost, omotica ob vstajanju, občutljiva koža, izguba okusa, pekoč občutek, tresenje pri usmerjenih gibih, poslabšano zavedanje, izguba zavesti, omedlevica, povečana občutljivost za hrup, slabo počutje.
English: • Sweating, rash, chills, fever.
Slovenian: • Znojenje, izpuščaj, mrzlica, zvišana telesna temperatura.
English: 50 mg capsules:
Slovenian: 50 mg kapsule:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/074-076
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/074-076
English: 150 mg capsules White opaque cap and body, capsule size 2 (18.0 mm x 6.4 mm) filled with white to nearly white coloured powder.
Slovenian: 150 mg kapsule Neprozorna pokrovček in telo bele barve, velikost kapsule 2 (18,0 mm x 6,4 mm), napolnjena s praškom bele do belkaste barve.
English: Vision loss, keratitis, oscillopsia, altered visual depth perception, mydriasis, strabismus, visual brightness
Slovenian: Redki izguba vida, keratitis, oscilopsija, spremenjeno vidno zaznavanje globine, midriaza, strabizem, občutek svetlosti pri gledanju
English: The maximum dose of 600 mg per day may be achieved after an additional week
Slovenian: Največji dovoljeni odmerek, ki se lahko doseže en teden pozneje,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/081-083
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/081-083
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/018-029
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/018-029
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/063-068
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/063-068
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/057-062
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/057-062
English: Immune system disorders
Slovenian: Bolezni imunskega sistema Občasni
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/011-017
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/011-017
English: 300 mg capsules Red opaque cap and pale yellow-brown opaque body, capsule size 0 (21.7 mm x 7.6 mm) filled with white to nearly white coloured powder.
Slovenian: 300 mg kapsule Neprozorni pokrovček rdeče barve in neprozorno telo blede rumenkastorjave barve, velikost kapsule 0 (21,7 mm x 7,6 mm), napolnjena s praškom bele do belkaste barve.
English: Hallucination, panic attack, restlessness, agitation, depression, depressed mood, elevated mood, aggression, mood swings, depersonalisation, word finding difficulty, abnormal dreams, libido increased, anorgasmia, apathy
Slovenian: Občasni halucinacije, napadi panike, nemir, agitiranost, depresija, potrtost, vzneseno razpoloženje, agresija, nihanje razpoloženja,
English: • Muscle cramp, joint pain, back pain, pain in limb.
Slovenian: • Krči mišic, bolečina v sklepih, bolečina v hrbtu, bolečina v udih.
English: 75 mg capsules Red opaque cap and white opaque body, capsule size 4 (14.3 mm x 5.3 mm) filled with white to nearly white coloured powder.
Slovenian: 75 mg kapsule Neprozorni pokrovček rdeče barve in belo neprozorno telo, velikost kapsule 4 (14,3 mm x 5,3 mm), napolnjena s praškom bele do belkaste barve.
English: White opaque cap and body, capsule size 2 (18.0 mm x 6.4 mm), filled with white to nearly white coloured powder.
Slovenian: Neprozorna pokrovček in telo bele barve, velikost kapsule 2 (18,0 mm x 6,4 mm), napolnjena s praškom bele do belkaste barve.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/001-010
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/001-010
English: • Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, swollen abdomen.
Slovenian: • Suha usta, zaprtje, bruhanje, napenjanje, driska, slabost s siljenjem na bruhanje, napihnjenost trebuha.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/042-052
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/042-052
English: Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172)
Slovenian: Ovojnica kapsule želatina titanov dioksid (E171) rumen železov oksid (E172) rdeč železov oksid (E172)
English: Unit dose blisters containing 14, 56, 84, 100 or 210 (3 x 70) hard capsules.
Slovenian: Pretisni omoti s posameznimi odmerki, ki vsebujejo 14, 56, 84, 100 ali 210 (3 x 70) trdih kapsul.
English: Unit dose blisters containing 56, 84, 100 or 210 (3 x 70) hard capsules.
Slovenian: Pretisni omoti s posameznimi odmerki, ki vsebujejo 56, 84, 100 ali 210 (3 x 70) trdih kapsul.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/031-033
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/031-033
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 225 mg of pregabalin.
Slovenian: Ena trda kapsula vsebuje 225 mg pregabalina.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/054-056
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/054-056
English: INFORMATION IN BRAILLE Pregabalin Sandoz 300 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Sandoz 300 mg
English: 225 mg capsules Pale orange opaque cap and white opaque body, capsule size 1 (19.4 mm x 6.9 mm) filled with white to nearly white coloured powder.
Slovenian: 225 mg kapsule Neprozorni pokrovček svetlo oranžne barve in neprozorno telo bele barve, velikost kapsule 1 (19,4 mm x 6,9 mm), napolnjena s praškom bele do belkaste barve.
English: Blisters containing 21, 28, 84 or 100 hard capsules.
Slovenian: Pretisni omoti, ki vsebujejo 21, 28, 84 ali 100 trdih kapsul.
English: INFORMATION IN BRAILLE Pregabalin Sandoz 75 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Sandoz 75 mg
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 75 mg of pregabalin.
Slovenian: Ena trda kapsula vsebuje 75 mg pregabalina.
English: INFORMATION IN BRAILLE Pregabalin Sandoz 150 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Sandoz 150 mg
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 225 mg hard capsules
Slovenian: Pregabalin Sandoz 225 mg trde kapsule
English: PVC/PVDC//Alu unit dose blisters packed in carton HDPE container with PP screw cap packed in carton.
Slovenian: Vsebnik HDPE s PP navojnim pokrovčkom v škatli.
English: Red opaque cap and pale yellow-brown opaque body, capsule size 0 (21.7 mm x 7.6 mm), filled with white to nearly white coloured powder.
Slovenian: Neprozorni pokrovček rdeče barve in neprozorno telo blede rumenkasto-rjave barve, velikost kapsule 0 (21,7 mm x 7,6 mm), napolnjena s praškom bele do belkaste barve.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 200 mg of pregabalin.
Slovenian: Ena trda kapsula vsebuje 200 mg pregabalina.
English: CZ-140 00 Praha 4 - Nusle Tel: +420 225 775 111 office.cz@sandoz.com
Slovenian: Na Pankráci 1724/129 CZ-140 00 Praha 4 - Nusle Tel: +420 225 775 111
English: • Increased saliva production, heartburn, numb around mouth.
Slovenian: • Močnejše slinjenje, zgaga, otrplost okrog ust.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/085
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/085
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/084
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/084
English: INFORMATION IN BRAILLE Pregabalin Sandoz 25 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Sandoz 25 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/069-073
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/069-073
English: Pharmacotherapeutic group: Anti epileptics, other anti-epileptics ATC code: N03AX16 The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3(aminomethyl)-5-methylhexanoic acid].
Slovenian: Učinkovina pregabalin je analog gama-aminomaslene kisline [(S)-3-(aminometil)-5-metilheksanojska kislina].
English: Titanium dioxide (E171) Iron oxide yellow (E172)
Slovenian: Ovojnica kapsule želatina titanov dioksid (E171) rumen železov oksid (E172)
English: 50 mg capsules Light yellow opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm) filled with white to nearly white coloured powder.
Slovenian: 50 mg kapsule Neprozorna pokrovček in telo svetlorumene barve, velikost kapsule 3 (15,9 mm x 5,8 mm), napolnjena s praškom bele do belkaste barve.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 300 mg of pregabalin.
Slovenian: Ena trda kapsula vsebuje 300 mg pregabalina.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/034-041
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/034-041
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 150 mg of pregabalin.
Slovenian: Ena trda kapsula vsebuje 150 mg pregabalina.
English: 100 mg capsules Red opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm) filled with white to nearly white coloured powder.
Slovenian: 100 mg kapsule Neprozorna pokrovček in telo rdeče barve, velikost kapsule 3 (15,9 mm x 5,8 mm), napolnjena s praškom bele do belkaste barve.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 150 mg hard capsules
Slovenian: Pregabalin Sandoz 150 mg trde kapsule
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg of pregabalin.
Slovenian: Ena trda kapsula vsebuje 100 mg pregabalina.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 25 mg of pregabalin.
Slovenian: Ena trda kapsula vsebuje 25 mg pregabalina.
English: 21 hard capsules 28 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Slovenian: 21 trdih kapsul 28 trdih kapsul 84 trdih kapsul 100 trdih kapsul 84 x 1 trda kapsula 100 x 1 trda kapsula
English: Hypotension, hypertension, hot flushes, flushing, peripheral coldness Respiratory, thoracic and mediastinal disorders
Slovenian: Žilne bolezni Občasni hipotenzija, hipertenzija, vročinski oblivi, pordevanje, hladne okončine Bolezni dihal, prsnega koša in mediastinalnega prostora Občasni dispneja, epistaksa, kašelj, zamašenost nosu, rinitis, smrčanje, suhost nosu
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/053
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/053
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 300 mg hard capsules
Slovenian: Pregabalin Sandoz 300 mg trde kapsule
English: INFORMATION IN BRAILLE Pregabalin Sandoz 225 mg
Slovenian: Pregabalin Sandoz 225 mg
English: The following events have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and dizziness, suggestive of physical dependence.
Slovenian: anksioznost, driska, gripozni sindrom, živčnost, depresija, bolečine, krči, hiperhidroza in omotica; le-ti kažejo na fizično odvisnost.
English: • Convulsions.
Slovenian: • Oteženo požiranje.
English: 200 mg capsules Pale orange opaque cap and body, capsule size 1 (19.4 mm x 6.9 mm) filled with white to nearly white coloured powder.
Slovenian: 200mg kapsule Neprozorna pokrovček in telo svetlo oranžne barve, velikost kapsule1 (19,4 mm x 6,9 mm), napolnjena s praškom bele do belkaste barve.
English: Red opaque cap and white opaque body, capsule size 4 (14.3 mm x 5.3 mm), filled with white to nearly white coloured powder.
Slovenian: Neprozorni pokrovček rdeče barve in belo neprozorno telo, velikost kapsule 4 (14,3 mm x 5,3 mm), napolnjena s praškom bele do belkaste barve.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/030
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/030
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 100 mg hard capsules
Slovenian: Pregabalin Sandoz 100 mg trde kapsule
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 200 mg hard capsules
Slovenian: Pregabalin Sandoz 200 mg trde kapsule
English: Blister packs: 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules Blister packs (unit dose): 14 x 1, 56 x 1, 84 x 1, 100 x 1 or 210 x 1 (3 x 70) hard capsules.
Slovenian: Pretisni omoti (posamezni odmerkii): 14 x 1, 56 x 1, 84 x 1, 100 x 1 ali 210 x 1 (3 x 70) trdih kapsul.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 75 mg hard capsules
Slovenian: Pregabalin Sandoz 75 mg trde kapsule