FrancophonIA/ELRC3.0 huggingface dataset:
English: belongs to a group of medicines used to treat epilepsy, neuropathic pain and generalised anxiety disorder (GAD) in adults.
Croatian: Pregabalin Zentiva k.s. pripada skupini lijekova koji se koriste za liječenja epilepsije, neuropatske boli i generaliziranog anksioznog poremećaja (GAP) u odraslih osoba.
English: is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako Vam se čini da je djelovanje lijeka Pregabalin Zentiva k.s. prejako ili preslabo, porazgovarajte sa svojim liječnikom ili ljekarnikom.
English: • There have been reports of convulsions when taking pregabalin or shortly after stopping pregabalin.
Croatian: • Za vrijeme uzimanja ili nedugo nakon prestanka uzimanja pregabalina prijavljene su konvulzije.
English: Pregabalin clearance tends to decrease with increasing age.
Croatian: Starije osobe Klirens pregabalina smanjuje se starenjem.
English: Additional reactions reported from post-marketing experience are included in italics in the list below.
Croatian: Dodatne nuspojave prijavljene nakon stavljanja lijeka u promet u Tablici ispod navedene su kurzivom.
English: Funduscopic changes were observed in 1.7% of pregabalintreated 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: 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: • Certain side effects may be more common, such as sleepiness, because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, that have similar side effects to pregabalin and the severity of these effects may be increased when taken together.
Croatian: • Neke nuspojave, poput pospanosti, mogu se javljati češće jer bolesnici s ozljedom leđne moždine možda uzimaju druge lijekove za liječenje, primjerice, boli ili grčeva, koji imaju slične nuspojave kao pregabalin.
English: In addition to the daily dose, a supplementary dose should be given immediately following every 4 hour haemodialysis treatment (see table 1).
Croatian: Uz dnevnu dozu treba dati dopunsku dozu pregabalina odmah nakon svakog četverosatnog postupka hemodijalize
English: Creatinine clearance (CLcr) (ml/min)
Croatian: Prilagodba doze pregabalina na temelju funkcije bubrega Klirens kreatinina (CLcr) (ml/min)
English: The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contain red iron oxide (E172), yellow iron oxide (E172).
Croatian: Kapsule od 75 mg, 100 mg, 200 mg, 225 mg i 300 mg sadrže i crveni željezov oksid (E172), žuti željezov oksid (E172).
English: • Change in perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attack, apathy, aggression, elevated mood, mental impairment, difficulty with thinking, increase in sexual interest, problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation.
Croatian: • promijenjena slika o sebi, nemir, depresija, uznemirenost, promjene raspoloženja, poteškoće u pronalaženju riječi, halucinacije, neuobičajeni snovi, napadaj panike, apatija, agresija, povišeno raspoloženje, slabljenje mentalnih sposobnosti, poteškoće pri razmišljanju, povećanje seksualne želje, tegobe sa spolnom funkcijom uključujući nemogućnost postizanja orgazma, odgođena ejakulacija
English: Red iron oxide (E172)
Croatian: • crveni željezov oksid (E172)
English: for you to help treat your epilepsy when your current treatment is not controlling your condition.
Croatian: Liječnik će Vam propisati Pregabalin Zentiva k.s. za liječenje epilepsije kada lijekovi koje ste do sada uzimali bolest ne drže pod kontrolom.
English: Capsule body
Croatian: Tijelo kapsule
English: Hallucination, panic attack, restlessness, agitation, depression, depressed mood, elevated mood, aggression, mood swings, depersonalisation, word finding difficulty, abnormal dreams, libido increased, anorgasmia, apathy
Croatian: Manje često halucinacije, napadaj panike, nemir, agitacija, depresija, depresivno raspoloženje, povišeno raspoloženje, agresija, promjene raspoloženja, depersonalizacija, poteškoće u pronalaženju riječi, neuobičajeni snovi, pojačan libido, anorgazmija,
English: (p = 0.0068 versus placebo), 29.1% of subjects treated with pregabalin 2.5 mg/kg/day (p = 0.2600 versus placebo) and 22.6% of those receiving placebo.
Croatian: Najmanje 50%-tno smanjenje parcijalnih napadaja od početka ispitivanja imalo je 40,6% ispitanika liječenih pregabalinom u dozi od 10 mg/kg na dan (p=0,0068 naspram placeba), 29,1% ispitanika liječenih pregabalinom u dozi od 2,5 mg/kg na dan (p=0,2600 naspram placeba ) i 22,6% onih koji su primali placebo.
English: Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.
Croatian: 7 dana može povećati na 300 mg na dan te, po potrebi, nakon dodatnih 7 dana na maksimalnu dozu od 600 mg na dan.
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 35% bolesnika liječenih pregabalinom i 18% bolesnika koji su primali placebo zabilježeno je 50%-tno poboljšanje rezultata procjene boli.
English: is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
Croatian: Pregabalin Zentiva k.s. indiciran je za liječenje generaliziranog anksioznog poremećaja (GAP) u odraslih osoba.
English: Reduced acoustic startle response was observed in juvenile rats 1 - 2 weeks after exposure at > 2 times the human therapeutic exposure.
Croatian: U mladih je štakora nakon 1-2 tjedna izloženosti > 2 puta većoj od terapijske izloženosti u ljudi opažena umanjena reakcija straha na akustične podražaje.
English: once in the morning, once in the afternoon and once in the evening, at about the same time each day.
Croatian: Ako Pregabalin Zentiva k.s. uzimate tri puta na dan, uzmite jednu dozu ujutro, jednu dozu poslijepodne te jednu navečer, svakoga dana otprilike u isto vrijeme.
English: If you stop taking Pregabalin Zentiva k.s.
Croatian: Ako prestanete uzimati Pregabalin Zentiva k.s.
English: Metabolism and nutrition disorders Common
Croatian: Poremećaji metabolizma i prehrane Često pojačan tek
English: 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg hard capsules are packed into PVC/alu blisters as primary packaging.
Croatian: Pregabalin Zentiva k.s. 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg i 300 mg tvrde kapsule zapakirane su u PVC/alu blistere kao primarno pakiranje.
English: may be taken with oral contraceptives.
Croatian: Pregabalin Zentiva k.s. može se uzimati s oralnim kontraceptivima.
English: Capsules content Lactose monohydrate Pregelatinized maize starch Talc
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari Sadržaj kapsula laktoza hidrat kukuruzni škrob, prethodno geliran talk
English: If you forget to take Pregabalin Zentiva k.s.
Croatian: Ako ste zaboravili uzeti Pregabalin Zentiva k.s.
English: neutropenia, increase in blood creatinine, decrease in blood potassium).
Croatian: smanjen broj krvnih pločica, smanjen broj neutrofila, povećanje kreatinina u krvi, snižene vrijednosti kalija u krvi)
English: 75 mg, 150 mg, 225 mg and 300 mg is available in pack of 14, 56, 98 and 100 hard capsules.
Croatian: Pregabalin Zentiva k.s. 75 mg, 150 mg, 225 mg i 300 mg dostupni su u pakiranjima od 14, 56, 98 i 100 tvrdih kapsula.
English: 100 mg, 200 mg is available in pack of 21, 84, 98 and 100 hard capsules.
Croatian: Pregabalin Zentiva k.s. 100 mg, 200 mg dostupni su u pakiranjima od 21, 84, 98 i 100 tvrdih kapsula.
English: In the 12-week placebo controlled study, paediatric patients (4 to 16 years of age) 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: 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: Dose adjustment in patients with reduced renal function or undergoing haemodialysis is necessary (see section 4.2 table 1).
Croatian: Potrebno je prilagoditi dozu u bolesnika čija je bubrežna funkcija smanjena ili koji se liječe hemodijalizom (vidjeti dio 4.2, Tablica 1).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics; ATC code: N03AX16.
Croatian: Farmakoterapijska skupina: Antiepileptici, ostali antiepileptici;
English: Capsule shell
Croatian: Kapica kapsule
English: 225 mg capsules
Croatian: Kapsule od 225 mg
English: Zentiva France Tél: +33 (0) 800 089 219 PV-France@zentiva.com
Croatian: Tél: +33 (0) 800 089 219 PV-France@zentiva.com
English: 25 mg and 50 mg is available in pack of 14, 21, 56, 84, 98 and 100 hard capsules.
Croatian: Pregabalin Zentiva k.s. 25 mg i 50 mg dostupni su u pakiranjima od 14, 21, 56, 84, 98 i 100 tvrdih kapsula.
English: 300 mg capsules
Croatian: Kapsule od 300 mg
English: Dyspnoea, epistaxis, cough, nasal congestion, rhinitis, snoring, nasal dryness
Croatian: Manje često dispneja, epistaksa, kašalj, kongestija nosa, rinitis, hrkanje, suhoća nosa
English: 75 mg capsules
Croatian: Kapsule od 75 mg
English: In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, CNS adverse reactions and especially somnolence was increased (see section 4.4).
Croatian: Navedene nuspojave mogu biti povezane i s osnovnom bolešću i/ili istodobno primijenjenim lijekovima.U liječenju centralne neuropatske boli uzrokovane ozljedom leđne moždine zabilježena je povećana incidencija nuspojava općenito te nuspojava SŽS-a, a osobito somnolencije (vidjeti dio 4.4).
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, koje upućuju na fizičku ovisnost.
English: Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbance, fatigue (tiredness), and can have an impact on physical and social functioning and overall quality of life.
Croatian: Osjet bola može se opisati kao vrućina, žarenje, pulsirajuća bol, sijevajuća bol. probadanje, oštra bol, grčevi, stalna tupa bol, trnci utrnulost, bockanje.Periferna i centralna neuropatska bol mogu biti povezane s promjenama raspoloženja, poremećajem spavanja te umorom (iscrpljenošću), a mogu utjecati na tjelesno i socijalno funkcioniranje i ukupnu kvalitetu života.
English: How to take Pregabalin Zentiva k.s.
Croatian: Kako uzimati Pregabalin Zentiva k.s.
English: 14 hard capsules 56 hard capsules 98 hard capsules 100 hard capsules
Croatian: 14 tvrdih kapsula 56 tvrdih kapsula 98 tvrdih kapsula 100 tvrdih kapsula
English: Neutropaenia
Croatian: Nuspojave
English: Excipient with known effect: Each hard capsule also contains 47.57 mg lactose monohydrate.
Croatian: Pomoćna tvar s poznatim učinkom: jedna tvrda kapsula također sadrži 47,57 mg laktoza hidrata.
English: Nasopharyngitis
Croatian: ginekomastija
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. 4.4 Posebna upozorenja i mjere opreza pri uporabi Bolesnici sa šećernom bolešću
English: Vomiting, nausea, constipation, diarrhoea, flatulence, abdominal distension, dry mouth
Croatian: Poremećaji probavnog sustava Često povraćanje, mučnina, konstipacija, proljev, flatulencija, distenzija abdomena, suha usta
English: 50 mg capsules
Croatian: Kapsule od 50 mg
English: Each hard capsule contains 225 mg of pregabalin.
Croatian: Jedna tvrda kapsula sadrži 225 mg pregabalina.
English: Oedema peripheral, oedema, gait abnormal, fall, feeling drunk, feeling abnormal, fatigue
Croatian: Opći poremećaji i reakcije na mjestu primjene Često periferni edem, edem, neuobičajen hod, pad, osjećaj pijanosti, neuobičajeno osjećanje, umor
English: The 25 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg capsules also contain polyethylene glycol.
Croatian: Kapsule od 25 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg i 300 mg sadrže i polietilenglikol.
English: After stopping long and short-term pregabalin treatment, you need to know that you may experience certain side effects.
Croatian: Morate znati da nakon prekida dugotrajnog i kratkotrajnog liječenja pregabalinom mogu nastupiti određene nuspojave.
English: Adjunctive treatment
Croatian: Epilepsija Dodatna terapija
English: Marketing Authorisation Holder Zentiva, k.s.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Zentiva, k.s.
English: • Hypersensitivity, swollen face, itchiness, hives, runny nose, nose bleed, cough, snoring.
Croatian: • preosjetljivost, oticanje lica, svrbež, koprivnjača, curenje iz nosa, krvarenje iz nosa, kašalj,
English: In controlled trials, a higher proportion of patients treated with pregabalin reported blurred vision than did patients treated with placebo which resolved in a majority of cases with continued dosing.
Croatian: U kontroliranim je ispitivanjima zamagljen vid prijavio veći udio bolesnika liječenih pregabalinom nego bolesnika koji su primali placebo.
English: 21 hard capsules 84 hard capsules 98 hard capsules 100 hard capsules
Croatian: 84 tvrde kapsule 98 tvrdih kapsula 100 tvrdih kapsula
English: until your doctor tells you to stop.
Croatian: Nastavite uzimati Pregabalin Zentiva k.s. dok Vam liječnik ne kaže da prestanete.
English: BATCH NUMBER Batch:
Croatian: 13. BROJ SERIJE Serija:
English: Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.
Croatian: Jedna tvrda kapsula sadrži 25 mg, 50 mg, 75 mg, 100 mg, 150 mg,
English: with food, drink and alcohol Pregabalin Zentiva k.s.
Croatian: Pregabalin Zentiva k.s. s hranom, pićem i alkoholom Pregabalin Zentiva k.s. tvrde kapsule mogu se uzimati s hranom ili bez nje.
English: Vision loss, keratitis, oscillopsia, altered visual depth perception, mydriasis, strabismus, visual brightness
Croatian: Rijetko gubitak vida, keratitis, oscilopsija, promjena percepcije dubine, midrijaza, strabizam, osjećaj svjetline pri gledanju
English: How to store Pregabalin Zentiva k.s.
Croatian: Kako čuvati Pregabalin Zentiva k.s.
English: Excipient with known effect: Each hard capsule also contains 22.5 mg lactose monohydrate.
Croatian: Pomoćna tvar s poznatim učinkom: jedna tvrda kapsula također sadrži 22,5 mg laktoza hidrata.
English: You can also report any side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: • Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, platelet count decreased,
Croatian: povišene vrijednosti alanin aminotransferaze, povišene vrijednosti aspartat aminotransferaze,
English: Hard capsule
Croatian: Kapsule
English: There have been post-marketing reports of congestive heart failure in some patients receiving pregabalin.
Croatian: Nakon stavljanja lijeka u promet, u nekih bolesnika koji su primali pregabalin prijavljeno je kongestivno zatajenje srca.
English: Hypotension, hypertension, hot flushes, flushing, peripheral coldness Respiratory, thoracic and mediastinal disorders Uncommon
Croatian: Krvožilni poremećaji Manje često hipotenzija, hipertenzija, navale vrućine, navale crvenila, hladnoća perifernih dijelova tijela
English: 14 hard capsules 21 hard capsules 56 hard capsules 84 hard capsules 98 hard capsules 100 hard capsules
Croatian: 56 tvrdih kapsula 84 tvrde kapsule 98 tvrdih kapsula 100 tvrdih kapsula
English: is used to treat generalised anxiety disorder (GAD).
Croatian: Pregabalin Zentiva k.s. se koristi za liječenje generaliziranog anksioznog poremećaja (GAP).
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 225 mg of pregabalin.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tvrda kapsula sadrži 225 mg pregabalina.
English: 150 mg
Croatian: Kapsule od 150 mg
English: Red cap and light grey body; approx. 21,7 mm in length, hard gelatin capsule with imprinting “300”, containing almost white powder.
Croatian: Tvrda želatinska kapsula duljine približno 21,7 mm, s crvenom kapicom, svjetlosivim tijelom i otisnutom oznakom “300”, koja sadrži gotovo bijeli prašak.
English: Table 2: Pregabalin Adverse Drug Reactions
Croatian: Tablica 2: Nuspojave pregabalina Organski sustav
English: Excipient with known effect: Each hard capsule also contains 7.5 mg lactose monohydrate.
Croatian: Pomoćna tvar s poznatim učinkom: jedna tvrda kapsula također sadrži 7,5 mg laktoza hidrata.
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: Red cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “75”, containing almost white powder.
Croatian: Tvrda želatinska kapsula duljine približno 14,3 mm, s crvenom kapicom, svjetlosivim tijelom i otisnutom oznakom “75”, koja sadrži gotovo bijeli prašak.
English: Pregabalin Zentiva k.s.
Croatian: Zentiva k.s.
English: Excipient with known effect: Each hard capsule also contains 20 mg lactose monohydrate.
Croatian: Pomoćna tvar s poznatim učinkom: jedna tvrda kapsula također sadrži 20 mg laktoza hidrata.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 75 mg of pregabalin.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tvrda kapsula sadrži 75 mg pregabalina.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 300 mg of pregabalin.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tvrda kapsula sadrži 300 mg pregabalina.
English: Black iron oxide (E172) Titanium dioxide (E171) Gelatin
Croatian: • titanijev dioksid (E171)
English: Renal failure, oliguria, urinary retention Reproductive system and breast disorders Common
Croatian: Rijetko zatajenje bubrega, oligurija, retencija mokraće
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 200 mg of pregabalin.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tvrda kapsula sadrži 200 mg pregabalina.
English: Light grey cap and light grey body; approx. 18,0 mm in length, hard gelatin capsule with imprinting “150”, containing almost white powder.
Croatian: Tvrda želatinska kapsula duljine približno 18,0 mm, sa svjetlosivom kapicom, svjetlosivim tijelom i otisnutom oznakom “150”, koja sadrži gotovo bijeli prašak.
English: 100 mg capsules Red cap and red body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “100”, containing almost white powder.
Croatian: Tvrda želatinska kapsula duljine približno 15,9 mm, s crvenom kapicom, crvenim tijelom i otisnutom oznakom “100”, koja sadrži gotovo bijeli prašak.
English: Excipient with known effect: Each hard capsule also contains 30 mg lactose monohydrate.
Croatian: Pomoćna tvar s poznatim učinkom: jedna tvrda kapsula također sadrži 30 mg laktoza hidrata.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 100 mg of pregabalin.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tvrda kapsula sadrži 100 mg pregabalina.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 150 mg of pregabalin.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tvrda kapsula sadrži 150 mg pregabalina.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 25 mg of pregabalin.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tvrda kapsula sadrži 25 mg pregabalina.
English: Light grey cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “50”, containing almost white powder.
Croatian: Tvrda želatinska kapsula duljine približno 14,3 mm, sa svjetlosivom kapicom, svjetlosivim tijelom i otisnutom oznakom “50”, koja sadrži gotovo bijeli prašak.
English: 200 mg hard capsules Pregabalin Zentiva k.s.
Croatian: Pregabalin Zentiva k.s. 200 mg tvrde kapsule pregabalin
English: 150 mg hard capsules Pregabalin Zentiva k.s.
Croatian: Pregabalin Zentiva k.s. 150 mg tvrde kapsule pregabalin
English: Hrvatska
Croatian: • grlobolja
English: Excipient with known effect: Each hard capsule also contains 5 mg lactose monohydrate.
Croatian: Pomoćna tvar s poznatim učinkom: jedna tvrda kapsula također sadrži 5 mg laktoza hidrata.
English: Excipient with known effect: Each hard capsule also contains 15 mg lactose monohydrate.
Croatian: Pomoćna tvar s poznatim učinkom: jedna tvrda kapsula također sadrži 15 mg laktoza hidrata.
English: • Breast pain.
Croatian: • upala gušterače
English: Black iron oxide (E172) Propylene glycol
Croatian: • crni željezov oksid (E172)
English: Excipient with known effect: Each hard capsule also contains 10 mg lactose monohydrate.
Croatian: Pomoćna tvar s poznatim učinkom: jedna tvrda kapsula također sadrži 10 mg laktoza hidrata.
English: Flesh opaque cap and light grey body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “225”, containing almost white powder.
Croatian: Tvrda želatinska kapsula duljine približno 19,4 mm, s neprozirnom kapicom boje mesa, svjetlosivim tijelom i otisnutom oznakom “225”, koja sadrži gotovo bijeli prašak.
English: 100 mg hard capsules Pregabalin Zentiva k.s.
Croatian: Pregabalin Zentiva k.s. 100 mg tvrde kapsule pregabalin
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 50 mg of pregabalin.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tvrda kapsula sadrži 50 mg pregabalina.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva logo
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: 225 mg hard capsules Pregabalin Zentiva k.s.
Croatian: Pregabalin Zentiva k.s. 225 mg tvrde kapsule pregabalin
English: Light grey cap and light grey body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “25”, containing almost white powder.
Croatian: Tvrda želatinska kapsula duljine približno 15,9 mm, sa svjetlosivom kapicom, svjetlosivim tijelom i otisnutom oznakom “25”, koja sadrži gotovo bijeli prašak.
English: 200 mg capsules Flesh opaque cap and Flesh opaque body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “200”, containing almost white powder.
Croatian: Tvrda želatinska kapsula duljine približno 19,4 mm, s neprozirnom kapicom boje mesa, neprozirnim tijelom boje mesa i otisnutom oznakom “200”, koja sadrži gotovo bijeli prašak.
English: 75 mg hard capsules Pregabalin Zentiva k.s.
Croatian: Pregabalin Zentiva 75 k.s. mg tvrde kapsule pregabalin
English: Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često grčevi u mišićima, artralgija, bol u leđima, bol u udovima, cervikalni spazam
English: Reduction of pregabalin dose may be required in patients who have age related compromised renal function (see section 4.2 table 1).
Croatian: U bolesnika čija je bubrežna funkcija oslabljena zbog starije dobi možda će biti potrebno smanjiti dozu pregabalina (vidjeti dio 4.2, Tablica 1).
English: 225 mg hard capsules Capsule cap
Croatian: Pregabalin Zentiva k.s. 225 mg tvrde kapsule
English: Strong ammonia solution Potassium hydroxide
Croatian: • propilenglikol • jaka otopina amonijaka
English: 25 mg hard capsules Pregabalin Zentiva k.s.
Croatian: Pregabalin Zentiva k.s. 25 mg tvrde kapsule pregabalin
English: 200 mg
Croatian: Kapsule od 200 mg