natgillin/translations-raw huggingface dataset:
The following reactions have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, convulsions, nervousness, depression, pain, hyperhidrosis and dizziness, suggestive of physical dependence.
Opisani so naslednji odzivi: nespečnost, glavobol, navzea, anksioznost, driska, gripozni sindrom, krči, živčnost, depresija, bolečine, hiperhidroza in omotica; le-ti kažejo na fizično odvisnost.
• Sore throat.
• Vneto žrelo.
How to store Pregabalin Sandoz
Shranjevanje zdravila Pregabalin Sandoz
Unit dose blisters containing 56 x 1, 84 x 1 or 100 x 1 hard capsules.
Pretisni omoti s posameznimi odmerki, ki vsebujejo 56 x 1, 84 x 1 ali 100 x 1 trdo kapsulo.
A meta- analysis of randomised placebo controlled studies of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
Majhno povečanje tveganja za pojav samomorilnega razmišljanja in vedenja je pokazala tudi metaanaliza randomiziranih, s placebom nadzorovanih kliničnih študij antiepileptikov.
NAME OF THE MARKETING AUTHORISATION HOLDER Sandoz
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sandoz GmbH
Adjunctive Treatment
Epilepsija Dodatno zdravljenje
Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172)
Ovojnica kapsule želatina titanov dioksid (E171) rumen železov oksid (E172) rdeč železov oksid (E172) črn železov oksid (E172)
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
EDINSTVENA OZNAKA -DVODIMENZIONALNA ČRTNA KODA <Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.> 18.
Blisters containing 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) or 120 (2 x 60) hard capsules.
Pretisni omoti, ki vsebujejo 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) ali 120 (2 x 60) trdih kapsul.
• Hypersensitivity, swollen face, itchiness, hives, runny nose, nose bleed, cough, snoring.
• Preobčutljivost, oteklost obraza, srbenje, koprivnica, izcedek iz nosu, krvavitve iz nosu, kašelj, smrčanje.
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.
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.
225 mg capsules: Blisters containing 14, 56, 70, 84,100 or 120 hard capsules.
225 mg kapsule: Pretisni omoti, ki vsebujejo 14, 56, 70, 84, 100 or 120 trdih kapsul.
EE-11312 Tallinn Tel.: +372 665 2400 Info.ee@sandoz.com
Tel.: +372 665 2400 Info.ee@sandoz.com
Ascites, pancreatitis, swollen tongue, dysphagia
Redki ascites, pankreatitis, oteklost jezika, disfagija
Unit dose blisters containing 56, 84 (2 x 42), 100 (2 x 50) or 210 (3 x 70) hard capsules.
Pretisni omoti s posameznimi odmerki, ki vsebujejo 56, 84 (2 x 42), 100 (2 x 50) ali 210 (3 x 70) trdih kapsul.
• Increased fluid in the abdomen.
• Nabiranje tekočine v trebušni votlini.
How to take Pregabalin Sandoz
Kako jemati zdravilo Pregabalin Sandoz
Vomiting, nausea, constipation, diarrhoea, flatulence, abdominal distension, dry mouth
Pogosti bruhanje, navzea, zaprtje, diareja, flatulenca, napetost trebušne stene, suha usta
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).
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).
Unit dose blisters containing 84 or 100 hard capsules.
Pretisni omoti s posameznimi odmerki, ki vsebujejo 84 ali 100 trdih kapsul.
Pregabalin Sandoz may produce dizziness, sleepiness and decreased concentration.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Pregabalin Sandoz lahko povzroči omotico, zaspanost in poslabša sposobnost koncentracije.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA ZA PRETISNE OMOTE
Dose regimen
PRETISNI OMOTI
• Dry eyes, eye swelling, eye pain, weak eyes, watery eyes, eye irritation.
• Suhe oči, otekanje oči, bolečine v očeh, zmanjšanje ostrine vida, solzenje, draženje oči.
• 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,
• 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.
• Sweating, rash, chills, fever.
• Znojenje, izpuščaj, mrzlica, zvišana telesna temperatura.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/074-076
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/074-076
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.
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.
Vision loss, keratitis, oscillopsia, altered visual depth perception, mydriasis, strabismus, visual brightness
Redki izguba vida, keratitis, oscilopsija, spremenjeno vidno zaznavanje globine, midriaza, strabizem, občutek svetlosti pri gledanju
The maximum dose of 600 mg per day may be achieved after an additional week
Največji dovoljeni odmerek, ki se lahko doseže en teden pozneje,
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/081-083
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/081-083
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/018-029
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/018-029
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/063-068
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/063-068
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/057-062
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/057-062
Immune system disorders
Bolezni imunskega sistema Občasni
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/011-017
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/011-017
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.
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.
Hallucination, panic attack, restlessness, agitation, depression, depressed mood, elevated mood, aggression, mood swings, depersonalisation, word finding difficulty, abnormal dreams, libido increased, anorgasmia, apathy
Občasni halucinacije, napadi panike, nemir, agitiranost, depresija, potrtost, vzneseno razpoloženje, agresija, nihanje razpoloženja,
• Muscle cramp, joint pain, back pain, pain in limb.
• Krči mišic, bolečina v sklepih, bolečina v hrbtu, bolečina v udih.
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.
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.
White opaque cap and body, capsule size 2 (18.0 mm x 6.4 mm), filled with white to nearly white coloured powder.
Neprozorna pokrovček in telo bele barve, velikost kapsule 2 (18,0 mm x 6,4 mm), napolnjena s praškom bele do belkaste barve.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/001-010
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/001-010
• Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, swollen abdomen.
• Suha usta, zaprtje, bruhanje, napenjanje, driska, slabost s siljenjem na bruhanje, napihnjenost trebuha.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/042-052
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/042-052
Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172)
Ovojnica kapsule želatina titanov dioksid (E171) rumen železov oksid (E172) rdeč železov oksid (E172)
Unit dose blisters containing 14, 56, 84, 100 or 210 (3 x 70) hard capsules.
Pretisni omoti s posameznimi odmerki, ki vsebujejo 14, 56, 84, 100 ali 210 (3 x 70) trdih kapsul.
Unit dose blisters containing 56, 84, 100 or 210 (3 x 70) hard capsules.
Pretisni omoti s posameznimi odmerki, ki vsebujejo 56, 84, 100 ali 210 (3 x 70) trdih kapsul.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/031-033
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/031-033
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 225 mg of pregabalin.
Ena trda kapsula vsebuje 225 mg pregabalina.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/054-056
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/054-056
INFORMATION IN BRAILLE Pregabalin Sandoz 300 mg
PODATKI V BRAILLOVI PISAVI Pregabalin Sandoz 300 mg
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.
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.
Blisters containing 21, 28, 84 or 100 hard capsules.
Pretisni omoti, ki vsebujejo 21, 28, 84 ali 100 trdih kapsul.
INFORMATION IN BRAILLE Pregabalin Sandoz 75 mg
PODATKI V BRAILLOVI PISAVI Pregabalin Sandoz 75 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 75 mg of pregabalin.
Ena trda kapsula vsebuje 75 mg pregabalina.
INFORMATION IN BRAILLE Pregabalin Sandoz 150 mg
PODATKI V BRAILLOVI PISAVI Pregabalin Sandoz 150 mg
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 225 mg hard capsules
Pregabalin Sandoz 225 mg trde kapsule
PVC/PVDC//Alu unit dose blisters packed in carton HDPE container with PP screw cap packed in carton.
Vsebnik HDPE s PP navojnim pokrovčkom v škatli.
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.
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.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 200 mg of pregabalin.
Ena trda kapsula vsebuje 200 mg pregabalina.
• Increased saliva production, heartburn, numb around mouth.
• Močnejše slinjenje, zgaga, otrplost okrog ust.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/085
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/085
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/084
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/084
INFORMATION IN BRAILLE Pregabalin Sandoz 25 mg
PODATKI V BRAILLOVI PISAVI Pregabalin Sandoz 25 mg
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/069-073
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/069-073
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].
Učinkovina pregabalin je analog gama-aminomaslene kisline [(S)-3-(aminometil)-5-metilheksanojska kislina].
Titanium dioxide (E171) Iron oxide yellow (E172)
Ovojnica kapsule želatina titanov dioksid (E171) rumen železov oksid (E172)
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.
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.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 300 mg of pregabalin.
Ena trda kapsula vsebuje 300 mg pregabalina.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/034-041
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/034-041
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 150 mg of pregabalin.
Ena trda kapsula vsebuje 150 mg pregabalina.
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.
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.
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 150 mg hard capsules
Pregabalin Sandoz 150 mg trde kapsule
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg of pregabalin.
Ena trda kapsula vsebuje 100 mg pregabalina.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 25 mg of pregabalin.
Ena trda kapsula vsebuje 25 mg pregabalina.
21 hard capsules 28 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
21 trdih kapsul 28 trdih kapsul 84 trdih kapsul 100 trdih kapsul 84 x 1 trda kapsula 100 x 1 trda kapsula
Hypotension, hypertension, hot flushes, flushing, peripheral coldness Respiratory, thoracic and mediastinal disorders
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
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/053
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/053
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 300 mg hard capsules
Pregabalin Sandoz 300 mg trde kapsule
INFORMATION IN BRAILLE Pregabalin Sandoz 225 mg
Pregabalin Sandoz 225 mg
The following events have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and dizziness, suggestive of physical dependence.
anksioznost, driska, gripozni sindrom, živčnost, depresija, bolečine, krči, hiperhidroza in omotica; le-ti kažejo na fizično odvisnost.
• Convulsions.
• Oteženo požiranje.
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.
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.
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.
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.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/030
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1011/030
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 100 mg hard capsules
Pregabalin Sandoz 100 mg trde kapsule
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 200 mg hard capsules
Pregabalin Sandoz 200 mg trde kapsule
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.
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.
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 75 mg hard capsules
Pregabalin Sandoz 75 mg trde kapsule
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 50 mg of pregabalin.
Ena trda kapsula vsebuje 50 mg pregabalina.
Red opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm), filled with white to nearly white coloured powder.
Neprozorna pokrovček in telo rdeče barve, velikost kapsule 3 (15,9 mm x 5,8 mm), napolnjena s praškom bele do belkaste barve.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept.
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 25 mg hard capsules
Pregabalin Sandoz 25 mg trde kapsule
Blisters containing 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules.
Pretisni omoti, ki vsebujejo 14, 21, 28, 56, 70, 84, 100 ali 120 trdih kapsul.
Blisters containing 14, 21, 28, 56, 84 or 100 hard capsules.
Pretisni omoti, ki vsebujejo 14, 21, 28, 56, 84 ali 100 trdih kapsul.
14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 70 hard capsules 56 x 1 hard capsules
14 trdih kapsul 21 trdih kapsul 28 trdih kapsul 56 trdih kapsul 70 trdih kapsul 56 x 1 trda kapsula
• Dilated pupils, cross eyes.
• Razširjene zenice, škiljenje.
Blisters containing 14, 28, 56, 70, 84, 100 or 120 hard capsules.
Pretisni omoti, ki vsebujejo 14, 28, 56, 70, 84, 100 ali 120 trdih kapsul.
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 50 mg hard capsules
Pregabalin Sandoz 50 mg trde kapsule
Pale orange opaque cap and body, capsule size 1 (19.4 mm x 6.9 mm), filled with white to nearly white coloured powder.
Neprozorna pokrovček in telo svetlo oranžne barve, velikost kapsule 1 (19,4 mm x 6,9 mm), napolnjena s praškom bele do belkaste barve.
INFORMATION IN BRAILLE Pregabalin Sandoz 200 mg
Pregabalin Sandoz 200 mg
Light yellow opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm), filled with white to nearly white coloured powder.
Neprozorna pokrovček in telo svetlorumene barve, velikost kapsule 3 (15,9 mm x 5,8 mm), napolnjena s praškom bele do belkaste barve.
INFORMATION IN BRAILLE Pregabalin Sandoz 100 mg
Pregabalin Sandoz 100 mg
14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 70 hard capsules 84 hard capsules 100 hard capsules 120 hard capsules 14 x 1 hard capsules 56 x 1 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
14 trdih kapsul 21 trdih kapsul 28 trdih kapsul 56 trdih kapsul 70 trdih kapsul 84 trdih kapsul 100 trdih kapsul 120 trdih kapsul 14 x 1 trda kapsula 56 x 1 trda kapsula 84 x 1 trda kapsula 100 x 1 trda kapsula
14 hard capsules 28 hard capsules 56 hard capsules 70 hard capsules 84 hard capsules 100 hard capsules 120 hard capsules 56 x 1 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
14 trdih kapsul 28 trdih kapsul 56 trdih kapsul 70 trdih kapsul 84 trdih kapsul 100 trdih kapsul 120 trdih kapsul 56 x 1 trda kapsula 84 x 1 trda kapsula 100 x 1 trda kapsula
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.
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.
• Inflammation of the pancreas.
• Epileptični krči.
• There have been reports of kidney failure in some patients when taking pregabalin .
• Pri nekaterih bolnikih, ki so jemali pregabalin, so opisani primeri odpovedi ledvic.
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.
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.
14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 70 hard capsules 84 hard capsules 100 hard capsules 120 hard capsules 56 x 1 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
14 trdih kapsul 21 trdih kapsul 28 trdih kapsul 56 trdih kapsul 70 trdih kapsul 84 trdih kapsul 100 trdih kapsul 120 trdih kapsul 56 x 1 trda kapsula 84 x 1 trda kapsula 100 x 1 trda kapsula
Multipack: 84 (2 packs of 42) hard capsules Multipack: 100 (2 packs of 50) hard capsules Multipack: 120 (2 packs of 60) hard capsules Multipack: 84 x 1 (2 packs of 42 x 1) hard capsules Multipack: 100 x 1 (2 packs of 50 x 1) hard capsules Multipack: 210 x 1 (3 packs of 70 x 1) hard capsules
Pretisni omoti (posamezni odmerki): 56 x 1, 84 x 1 (2 x 42), 100 x 1 (2 x 50) ali 210 x 1 (3 x 70) trdih kapsul.
14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
14 trdih kapsul 21 trdih kapsul 28 trdih kapsul 56 trdih kapsul 84 trdih kapsul 100 trdih kapsul 84 x 1 trda kapsula 100 x 1 trda kapsula
It is advised not to drink alcohol while taking Pregabalin Sandoz.
Če jemljete zdravilo Pregabalin Sandoz, odsvetujemo pitje alkohola.
INFORMATION IN BRAILLE Outer carton: Pregabalin Sandoz 150 mg
Škatla: Pregabalin Sandoz 150 mg
Blister packs: 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) or 120 (2 x 60) hard capsules Blister packs (unit dose): 56 x 1, 84 x 1 (2 x 42), 100 x 1 (2 x 50) or 210 x 1 (3 x 70) hard capsules Container packs: 100, 200 or 250 hard capsules
Pretisni omoti: 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) ali 120 (2 x 60) trdih kapsul.
Blister packs: 21, 28, 84 or 100 hard capsules Blister packs (unit dose): 84 x 1 or 100 x 1 hard capsules Not all pack sizes may be marketed.
Pretisni omoti (posamezni odmerki): 84 x 1 ali 100 x 1 trdih kapsul.
In small children this can be 4 to 6 times per day.
Pri majhnih otrocih je to lahko 4 do 6-krat dnevno.
Frequency cannot be estimated from the available data
ni mogoče oceniti iz razpoložljivih podatkov
Date of first authorisation: 08/12/1999 Date of latest renewal: 08/12/2009
Datum prve pridobitve: 08/12/1999 Datum zadnjega podaljšanja: 08/12/2009
Make sure that there are at least 3 hours between two doses.
Prepričajte se, da so minile najmanj 3 ure med dvema odmerkoma.
Your doctor will tell you how many tablets you should take.
Vaš zdravnik vam bo povedal, koliko tablet morate vzeti.
Three measuring spoons of different measures are provided.
Priložene so tri merilne žličke različnih mer.
If this occurs, please discuss it with your doctor, because the absence of your period may be caused by pregnancy (see Pregnancy and breast-feeding section above).
Če se to zgodi, se posvetujete s svojim zdravnikom, ker lahko izostanek menstruacije pomeni, da ste noseči (glejte poglavje Nosečnost in dojenje zgoraj).
The tablets should be taken with a large volume of water.
Zdravilo je treba jemati z veliko količino vode.
Your doctor will tell you the amount of granules you should take.
Zdravnik vam bo povedal količino zrnc, ki jih morate vzeti.
Do not use this medicine after the expiry date which is stated on the carton and the bottle label after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na plastenki poleg oznake “EXP”.
Patients with these rare disorders have a deficiency of certain liver enzymes and are therefore unable to eliminate nitrogen waste.
Bolniki s temi redkimi motnjami imajo premalo določenih encimov v jetrih in zato ne morejo odstranjevati odpadnega dušika.
You will need regular blood tests to determine the correct daily dose.
Opravljati boste morali redne krvne preiskave, da se bo določil pravilni dnevni odmerek zdravila AMMONAPS.
These medicines may change the effect of AMMONAPS and you will need more frequent blood controls.
Ta zdravila lahko spremenijo delovanje zdravila AMMONAPS in boste morali pogosteje na preiskave krvi.
- if you are pregnant.
- če ste noseči, - če dojite,
The volume of distribution of phenylbutyrate is 0.2 l/kg.
Volumen porazdelitve fenilbutirata je 0,2 l/kg.
Evaluation of experimental animal studies has shown reproductive toxicity, i.e. effects on the development of the embryo or the foetus.
Študije na živalih so pokazale reproduktivno toksičnost, tj. učinkovanje na razvoj zarodka ali ploda.
The safety of this medicinal product for use in human pregnancy has not been established.
Varnost tega zdravila med nosečnostjo še ni ugotovljena.
Common: Syncope, headache
Pogosti: sinkopa, glavobol