FrancophonIA/ELRC3.0 huggingface dataset:
English: Funduscopic changes were observed in 1.7% of pregabalin-treated and 2.1% of placebo-treated patients.
Croatian: Promjene očne pozadine opažene su u 1,7 % bolesnika liječenih pregabalinom i 2,1 % bolesnika koji su primali placebo.
English: HDPE container with PP screw cap.
Croatian: HDPE spremnik s PP navojnim zatvaračem.
English: Container packs: 100, 200 or 250 hard capsules
Croatian: Pakiranje sa spremnikom: 100, 200 ili 250 tvrdih kapsula.
English: PHARMACEUTICAL FORM AND CONTENTS 200 hard capsules
Croatian: OBLIK I SADRŽAJ 200 tvrdih kapsula
English: For patients not experiencing somnolence, such an improvement was observed in 33% of patients treated with pregabalin and 18% of patients on placebo.
Croatian: Među bolesnicima u kojih se nije javila somnolencija takvo je poboljšanje zabilježeno u 33 % bolesnika liječenih pregabalinom te 18 % bolesnika koji su primali placebo.
English: 42 hard capsules.
Croatian: 42 tvrde kapsule.
English: In the controlled clinical trial in central neuropathic pain 22% of the pregabalin treated patients and 7% of the patients on placebo had a 50% improvement in pain score.
Croatian: U kontroliranom kliničkom ispitivanju u centralnoj neuropatskoj boli je u 22 % bolesnika liječenih pregabalinom i 7 % bolesnika koji su primali placebo zabilježeno 50 %-tno poboljšanje rezultata procjene boli.
English: Pregabalin Sandoz is for oral use only.
Croatian: Pregabalin Sandoz je namijenjena samo za peroralnu primjenu.
English: In the postmarketing experience, there are reports of respiratory failure and coma in patients taking pregabalin and other central nervous system (CNS) depressant medicinal products.
Croatian: Nakon stavljanja lijeka u promet, u bolesnika koji su uzimali pregabalin i druge depresore središnjeg živčanog sustava (SŽS) prijavljeni su zatajenje disanja i koma.
English: In controlled clinical trials in peripheral neuropathic pain 35% of the pregabalin treated patients and 18% of the patients on placebo had a 50% improvement in pain score.
Croatian: U kontroliranim kliničkim ispitivanjima u perifernoj neuropatskoj boli je u 35 % bolesnika liječenih pregabalinom i 18 % bolesnika koji su primali placebo zabilježeno 50 %-tno poboljšanje rezultata procjene boli.
English: Tel: +34 900 456 856 registros.spain@sandoz.com
Croatian: 28033 Madrid SpainTel: +34 900 456 856 registros.spain@sandoz.com
English: Container packs: 200 hard capsules
Croatian: Pakiranje sa spremnikom: 200 tvrdih kapsula.
English: After stopping long and short-term Pregabalin Sandoz treatment, you need to know that you may experience certain side effects.
Croatian: Morate znati da nakon prekida dugotrajnog i kratkotrajnog liječenja lijekom Pregabalin Sandoz mogu nastupiti određene nuspojave.
English: In the 12-week placebo-controlled study, paediatric patients were assigned to pregabalin 2.5 mg/kg/day (maximum, 150 mg/day), pregabalin 10 mg/kg/day (maximum, 600 mg/day), or placebo.
Croatian: U 12-tjednom placebo-kontroliranom ispitivanju pedijatriski su bolesnici dobivali pregabalin u dozi od 2,5 mg / kg na dan (maksimalno 150 mg na dan), pregabalin 10 mg / kg na dan (maksimalno 600 mg na dan) ili placebo.
English: In all controlled studies, the discontinuation rate due to adverse reactions was 12% for patients receiving pregabalin and 5% for patients receiving placebo.
Croatian: U svim je kontroliranim kliničkim ispitivanjima udio bolesnika koji su prekinuli liječenje zbog nuspojava iznosio 12 % među bolesnicima koji su primali pregabalin te 5 % među bolesnicima koji su primali placebo.
English: How to take Pregabalin Sandoz
Croatian: Kako uzimati Pregabalin Sandoz
English: Generalised oedema, face oedema, chest tightness, pain, pyrexia, thirst, chills, asthenia
Croatian: Manje često generalizirani edem, edem lica, stezanje u prsima, bol, pireksija, žeđ, zimica, astenija
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.
Croatian: Kako Pregabalin Sandoz izgleda i sadržaj pakiranja 25 mg kapsule Blijedo žuto-smeđa neprozirna kapica i tijelo, kapsula veličine 4 (14,3 mm x 5,3 mm), ispunjena bijelim do gotovo bijelim praškom.
English: Peripheral vision loss, visual disturbance, eye swelling, visual field defect, visual acuity reduced, eye pain, asthenopia, photopsia, dry eye, lacrimation increased, eye irritation
Croatian: Manje često gubitak perifernog vida, poremećaj vida, oticanje oka, suženje vidnog polja, smanjena oštrina vida, bol u oku, astenopija, fotopsija, suhoća oka, pojačano suzenje, iritacija oka
English: For patients who experienced somnolence the responder rates were 48% on pregabalin and 16% on placebo.
Croatian: Među bolesnicima u kojih se javila somnolencija, udio onih koji su odgovorili na liječenje iznosio je 48 % u skupini koja je primala pregabalin te 16 % u skupini koja je primala placebo.
English: PVC/PVDC//Alu unit dose blisters packed in carton HDPE container with PP screw cap packed in carton.
Croatian: PVC/PVDC//aluminij blisterima djeljivima na jedinične doze pakiranima u kutiju.
English: The most common adverse events observed in the 12-week study with pregabalin treatment were somnolence, pyrexia, upper respiratory tract infection, increased appetite, weight increased, and nasopharyngitis (see sections 4.2, 5.1 and 5.2).
Croatian: Najčešći štetni događaji zabilježeni u 12 tjednom ispitivanjuvliječenja pregabalinom bili su somnolencija, pireksija, infekcija gornjih dišnih putova, povećani apetit, povećanje tjelesne težine i nazofaringitis (vidjeti dijelove 4.2, 5.1 i 5.2).
English: Česká republika Sandoz s.r.o.
Croatian: Sandoz s.r.o.
English: Unit dose blisters containing 84 x 1 hard capsules.
Croatian: Blisteri djeljivi na jedinične doze koji sadrže 84 x 1 tvrdih kapsula.
English: 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.
Croatian: Nema dovoljno podataka za ukidanje istodobno primijenjenih antiepileptika nakon što je dodavanjem pregabalina postignuta kontrola napadaja, a u cilju monoterapije pregabalinom.
English: Unit dose blisters containing 56 x 1, 84 x 1 or 100 x 1 hard capsules.
Croatian: Blisteri djeljivi na jedinične doze koji sadrže 56 x 1, 84 x 1 or 100 x 1 tvrdih kapsula.
English: No dose adjustment is required for patients with hepatic impairment (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem funkcije jetre (vidjeti dio 5.2).
English: Εθνική Οδός No 1 (12ο km) Μεταμόρφωση GR-144 51 Αθήνα Τηλ: +30 210 2811712
Croatian: Κηφισίας 18 & Γκύζη GR-151 25 Μαρούσι Τηλ: +30 216 600 500 0
English: You should take Pregabalin Sandoz in addition to your current treatment.
Croatian: Lijek Pregabalin Sandoz morate uzimati kao dodatak postojećim lijekovima.
English: 150 mg capsules:
Croatian: 150 mg kapsule:
English: Do not stop taking Pregabalin Sandoz unless your doctor tells you to.
Croatian: Ako prestanete uzimati lijek Pregabalin Sandoz Nemojte prestati uzimati lijek Pregabalin Sandoz ako Vam to ne kaže liječnik.
English: Generalised anxiety disorder Pregabalin Sandoz is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Croatian: Pregabalin Sandoz je indiciran za liječenje generaliziranog anksioznog poremećaja (GAP) u odraslih osoba.
English: • Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, swollen abdomen.
Croatian: • suha usta, zatvor, povraćanje, nadutost, proljev, mučnina, otečen trbuh
English: How to store Pregabalin Sandoz
Croatian: Kako čuvati Pregabalin Sandoz
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,
Croatian: • promjene vida, neuobičajeni pokreti očiju, promjene vida uključujući gubitak perifernog vida (kao da gledate kroz cijev), bljeskovi svjetla, trzajni pokreti, smanjeni refleksi, pojačana aktivnost, omaglica pri ustajanju, osjetljivost kože, gubitak osjeta okusa, osjećaj pečenja, tremor pri pokretima, smanjena svijest, gubitak svijesti, nesvjestica, pojačana osjetljivost na buku, opće loše osjećanje
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.
Croatian: Zabilježene su sljedeće reakcije: nesanica, glavobolja, mučnina, anksioznost, proljev, sindrom nalik gripi, konvulzije, nervoza, depresija, bol, hiperhidroza i omaglica koji upućuju na fizičku ovisnost.
English: Blisters containing 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) or 120 (2 x 60) hard capsules.
Croatian: Blisteri koji sadrže 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) ili 120 (2 x 60) tvrdih kapsula.
English: 75 mg capsules:
Croatian: 75 mg kapsule:
English: Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172)
Croatian: Ovojnica kapsule želatina titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172) željezov oksid, crni (E172)
English: Unit dose blisters containing 84 or 100 hard capsules.
Croatian: Blisteri djeljivi na jedinične doze koji sadrže 84 ili 100 tvrda kapsula.
English: 225 mg capsules: Blisters containing 14, 56, 70, 84,100 or 120 hard capsules.
Croatian: 225 mg kapsule: Blisteri koji sadrže 14, 56, 70, 84, 100 ili 120 tvrdih kapsula.
English: Blisters containing 21, 28, 84 or 100 hard capsules.
Croatian: Blisteri koji sadrže 21, 28, 84 ili 100 tvrdih kapsula.
English: Pregabalin treatment can be started with a dose of 150 mg per day given as two or three divided doses.
Croatian: Liječenje pregabalinom može započeti dozom od 150 mg na dan, podijeljeno u dvije ili tri doze.
English: Unit dose blisters containing 56, 84 (2 x 42), 100 (2 x 50) or 210 (3 x 70) hard capsules.
Croatian: Blisteri djeljivi na jedinične doze koji sadrže 56, 84 (2 x 42), 100 (2 x 50) ili 210 (3 x 70) tvrdih kapsula.
English: Sandoz Pharmaceuticals d.d.
Croatian: Sandoz Farmacéutica, S.A.
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).
Croatian: Rezultati 12tjednog placebom kontroliranog ispitivanja koje je provedeno u 295 pedijatrijskih bolesnika u dobi od 4 do 16 godina izvedenih za procjenu djelotvornosti i sigurnosti pregabalina kao dodatne terapije za liječenje parcijalnih napadaja i jednogodišnjeg otvorenog ispitivanja sigurnosti u 54 pedijatrijska bolesnika u dobi od 3 mjeseca do 16 godina starosti s epilepsijom ukazuju da su štetni događaji pireksija i infekcija gornjih dišnih putova zabilježeni češće nego u ispitivanjima u odraslih bolesnika s epilepsijom (vidjeti dijelove 4.2, 4.8 i 5.2).
English: 25 mg capsules:
Croatian: 25 mg kapsule:
English: 300 mg capsules:
Croatian: 300 mg kapsule:
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.
Croatian: Sigurnosni profil pregabalina zabilježen u tri pedijatrijska ispitivanja u bolesnika s parcijalnim napadajima sa sekundarnom generalizacijom ili bez nje (12 tjedno ispitivanje djelotvornosti i sigurnosti u bolesnika s parcijalnim napadajima, n=295, ispitivanje farmakokinetike i podnošljivosti,
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.
Croatian: 300 mg kapsule Crvena neprozirna kapica i blijedo žuto-smeđe neprozirno tijelo, kapsula veličine 0 (21,7 mm x 7,6 mm), ispunjena bijelim do gotovo bijelim praškom.
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.
Croatian: 150 mg kapsule Bijela neprozirna kapica i tijelo, kapsula veličine 2 (18,0 mm x 6,4 mm), ispunjena bijelim do gotovo bijelim praškom.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Sandoz
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Sandoz
English: 100 mg capsules:
Croatian: 100 mg kapsule:
English: White opaque cap and body, capsule size 2 (18.0 mm x 6.4 mm), filled with white to nearly white coloured powder.
Croatian: Bijela neprozirna kapica i tijelo, kapsula veličine 2 (18,0 mm x 6,4 mm), ispunjena bijelim do gotovo bijelim praškom.
English: 200 mg capsules:
Croatian: 200 mg kapsule:
English: 50 mg capsules:
Croatian: 50 mg kapsule:
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.
Croatian: Crvena neprozirna kapica i blijedo žuto-smeđe neprozirno tijelo, kapsula veličine 0 (21,7 mm x 7,6 mm), ispunjena bijelim do gotovo bijelim praškom.
English: INFORMATION IN BRAILLE Pregabalin Sandoz 225 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz 225 mg
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].
Croatian: Djelatna tvar je pregabalin, analog gama-aminomaslačne kiseline [(S)-3-(aminometil)-5-metilheksanoična kiselina].
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/018-029
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/018-029
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/011-017
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/011-017
English: Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172)
Croatian: Ovojnica kapsule želatina titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
English: Maize starch
Croatian: • upala gušterače
English: Unit dose blisters containing 14, 56, 84, 100 or 210 (3 x 70) hard capsules.
Croatian: Blisteri djeljivi na jedinične doze koji sadrže 14, 56, 84, 100 ili 210 (3 x 70) tvrdih kapsula.
English: Blister packs: 14, 28, 56, 70, 84, 100 or 120 hard capsules Blister packs (unit dose): 56 x 1, 84 x 1 or 100 x 1 hard capsules.
Croatian: Blister pakiranja: 14, 28, 56, 70, 84, 100 ili 120 tvrdih kapsula Blister pakiranja (djeljiva na jedinične doze): 56 x 1, 84 x 1 ili 100 x 1 tvrda kapsula.
English: Unit dose blisters containing 56, 84, 100 or 210 (3 x 70) hard capsules.
Croatian: Blisteri djeljivi na jedinične doze koji sadrže 56, 84, 100 ili 210 (3 x 70) tvrdih kapsula.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/001-010
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/001-010
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/074-076
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/074-076
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/081-083
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/081-083
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/057-062
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/057-062
English: • There have been reports of kidney failure in some patients when taking pregabalin .
Croatian: • U nekih je bolesnika pri uzimanju pregabalina prijavljeno zatajenje bubrega.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/054-056
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/054-056
English: INFORMATION IN BRAILLE Outer carton: Pregabalin Sandoz 150 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Vanjsko pakiranje: Pregabalin Sandoz 150 mg
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.
Croatian: 100 mg kapsule Crvena neprozirna kapica i tijelo, kapsula veličine 3 (15,9 mm x 5,8 mm), ispunjena bijelim do gotovo bijelim praškom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/063-068
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/063-068
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/042-052
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/042-052
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 225 mg hard capsules pregabalin
Croatian: Pregabalin Sandoz 225 mg tvrde kapsule pregabalin
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 225 mg of pregabalin.
Croatian: TVARI Jedna tvrda kapsula sadrži 225 mg pregabalina.
English: Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austrija
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.
Croatian: Crvena neprozirna kapica i bijelo neprozirno tijelo, kapsula veličine 4 (14,3 mm x 5,3 mm), ispunjena bijelim do gotovo bijelim praškom.
English: 14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 70 hard capsules 56 x 1 hard capsules
Croatian: 14 tvrdih kapsula 21 tvrda kapsula 28 tvrdih kapsula 56 tvrdih kapsula 70 tvrdih kapsula 56 x 1 tvrda kapsula
English: INFORMATION IN BRAILLE Pregabalin Sandoz 75 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz 75 mg
English: Tlf: + 45 6395 1000
Croatian: Tel: + 39 02 96541
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/031-033
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/031-033
English: 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.
Croatian: Blijeda žuto-smeđa neprozirna kapica i tijelo, kapsula veličine 4 (14,3 mm x 5,3 mm), ispunjena bijelim do gotovo bijelim praškom.
English: 14 hard capsules 56 hard capsules 70 hard capsules 84 hard capsules 100 hard capsules 120 hard capsules
Croatian: 14 tvrdih kapsula 56 tvrdih kapsula 70 tvrdih kapsula 84 tvrde kapsule 100 tvrdih kapsula 120 tvrdih kapsula
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING THE BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VANJSKOM OMOTU VIŠESTRUKOG PAKIRANJA UMOTANOG
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/085
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/085
English: Titanium dioxide (E171) Iron oxide yellow (E172)
Croatian: Ovojnica kapsule želatina titanijev dioksid (E171) željezov oksid, žuti (E172)
English: INFORMATION IN BRAILLE Pregabalin Sandoz 150 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz 150 mg
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 225 mg hard capsules
Croatian: Pregabalin Sandoz 225 mg tvrde kapsule
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 150 mg hard capsules pregabalin
Croatian: Pregabalin Sandoz 150 mg tvrde kapsule pregabalin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/069-073
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/069-073
English: INFORMATION IN BRAILLE Pregabalin Sandoz 200 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz 200 mg
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 75 mg of pregabalin.
Croatian: TVARI Jedna tvrda kapsula sadrži 75 mg pregabalina.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 200 mg of pregabalin.
Croatian: TVARI Jedna tvrda kapsula sadrži 200 mg pregabalina.
English: INFORMATION IN BRAILLE Pregabalin Sandoz 100 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz 100 mg
English: Pale orange opaque cap and body, capsule size 1 (19.4 mm x 6.9 mm), filled with white to nearly white coloured powder.
Croatian: Blijedo narančasta neprozirna kapica i tijelo, kapsula veličine 1 (19,4 mm x 6,9 mm), ispunjena bijelim do gotovo bijelim praškom.
English: 21 hard capsules 28 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Croatian: 21 tvrda kapsula 28 tvrdih kapsula 84 tvrde kapsule 100 tvrdih kapsula 84 x 1 tvrda kapsula 100 x 1 tvrda kapsula
English: Red opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm), filled with white to nearly white coloured powder.
Croatian: Crvena neprozirna kapica i tijelo, kapsula veličine 3 (15,9 mm x 5,8 mm), ispunjena bijelim do gotovo bijelim praškom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/053
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/053
English: INFORMATION IN BRAILLE Pregabalin Sandoz 300 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz 300 mg
English: Blister packs: 14, 21, 28, 56, 84 or 100 hard capsules Blister packs (unit dose): 84 x 1 or 100 x 1 hard capsules.
Croatian: Blister pakiranja: 14, 21, 28, 56, 84 ili 100 tvrdih kapsula Blister pakiranja (djeljiva na jedinične doze): 84 x 1 tvrda kapsula.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 150 mg of pregabalin.
Croatian: TVARI Jedna tvrda kapsula sadrži 150 mg pregabalina.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/034-041
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/034-041
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 200 mg hard capsules
Croatian: Pregabalin Sandoz 200 mg tvrde kapsule
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 150 mg hard capsules
Croatian: Pregabalin Sandoz 150 mg tvrde kapsule
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 200 mg hard capsules pregabalin
Croatian: Pregabalin Sandoz 200 mg tvrde kapsule pregabalin
English: INFORMATION IN BRAILLE Pregabalin Sandoz 25 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz 25 mg
English: 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.
Croatian: Blijedo narančasta neprozirna kapica i bijelo neprozirno tijelo, kapsula veličine 1 (19,4 mm x 6,9 mm), ispunjena bijelim do gotovo bijelim praškom.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 25 mg of pregabalin.
Croatian: TVARI Jedna tvrda kapsula sadrži 25 mg pregabalina.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 300 mg of pregabalin.
Croatian: TVARI Jedna tvrda kapsula sadrži 300 mg pregabalina.
English: • Flushing, hot flushes.
Croatian: • crvenilo uz osjećaj vrućine, navale vrućine
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/084
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/084
English: Blisters containing 14, 21, 28, 56, 84 or 100 hard capsules.
Croatian: Blisteri koji sadrže 14, 21, 28, 56, 84 ili 100 tvrdih kapsula.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 300 mg hard capsules pregabalin
Croatian: Pregabalin Sandoz 300 mg tvrde kapsule pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 100 mg hard capsules pregabalin
Croatian: Pregabalin Sandoz 100 mg tvrde kapsule pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 75 mg hard capsules
Croatian: Pregabalin Sandoz 75 mg tvrde kapsule
English: • Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal.
Croatian: • poremećaj pažnje, nespretnost, poremećaj pamćenja, gubitak pamćenja, drhtanje (tremor),