FrancophonIA/ELRC3.0 huggingface dataset:
English: Aliskiren has been evaluated for safety in a randomised, double-blind, 8-week study in 267 hypertensive patients aged 6 to 17 years, mostly overweight/obese, followed by an extension study including 208 patients treated for 52 weeks.
Croatian: Sigurnost aliskirena je procijenjena u randomiziranom, dvostruko-slijepom, 8-tjednom ispitivanju u kojem je sudjelovalo 267 hipertenzivnih bolesnika u dobi od 6 do 17 godina, uglavnom s prekomjernom težinom/pretili, nakon čega je slijedio nastavak ispitivanja koji je obuhvatio
English: In a pooled analysis of efficacy and safety data from clinical studies up to 12 months duration, there was no statistically significant difference in blood pressure reduction between aliskiren 300 mg and aliskiren 150 mg in elderly patients (≥ 65 years).
Croatian: U skupnoj analizi podataka o djelotvornosti i sigurnosti iz kliničkih ispitivanja trajanja do 12 mjeseci, nije bilo statistički značajne razlike u smanjenju krvnog tlaka između aliskirena
English: Multipack: 84 (3 packs of 28) film-coated tablets Multipack: 90 (3 packs of 30) film-coated tablets Multipack: 98 (2 packs of 49) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets
Croatian: Višestruko pakiranje: 84 (3 pakiranja od 28) filmom obložene tablete Višestruko pakiranje: 90 (3 pakiranja od 30) filmom obloženih tableta Višestruko pakiranje: 98 (2 pakiranja od 49) filmom obloženih tableta Višestruko pakiranje: 280 (20 pakiranja od 14) filmom obloženih tableta
English: Aliskiren is not recommended in patients with severe renal impairment (GFR < 30 ml/min/1.73 m2).
Croatian: Aliskiren se ne preporučuje bolesnicima s teškim oštećenjem bubrežne funkcije (GFR <30 ml/min/1,73 m2).
English: In obese hypertensive patients who did not adequately respond to HCTZ 25 mg, add-on treatment with aliskiren 300 mg provided additional blood pressure reduction that was comparable to add-on treatment with irbesartan 300 mg or amlodipine 10 mg.
Croatian: dodatno liječenje aliskirenom u dozi od 300 mg dovelo je do dodatnog sniženja krvnoga tlaka koje se moglo usporediti s dodatnim liječenjem od 300 mg irbesartana ili 10 mg amlodipina.
English: In this study, aliskiren at a target dose of 300 mg was compared to enalapril at a target dose of 20 mg when added to standard of care which included a beta blocker (and a mineralocorticoid receptor antagonist in 37% of patients) and a diuretic as needed.
Croatian: 20 mg kada se dodaju standardu skrbi koji uključuje beta-blokator (i antagonist mineralokortikoidnih receptora u 37% bolesnika) i diuretik po potrebi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX) CONTAINING PCTFE/PVC BLISTERS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU SREDNJA KUTIJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA) KOJA SADRŽI PCTFE/PVC BLISTERE
English: Rasilez 300 mg film-coated tablets are light-red, biconvex, ovaloid tablets, imprinted “IU” on one side and “NVR” on the other side.
Croatian: Rasilez 300 mg filmom obložene tablete su svijetlocrvene, bikonveksne, ovalne tablete, s utisnutom oznakom „IU“ na jednoj i „NVR“ na drugoj strani.
English: No adjustment of the initial dosage of treatment is required in patients with mild to moderate renal impairment (see sections 4.2 and 4.4).
Croatian: bolesnika s blagim do teškim oštećenjem bubrežne funkcije nije potrebna prilagodba početne doze liječenja (vidjeti dijelove 4.2 i 4.4).
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Croatian: 14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 56 filmom obloženih tableta 56 x 1 filmom obloženih tableta 90 filmom obloženih tableta 98 filmom obloženih tableta
English: In patients after 104 weeks (at LT Visit 19 [Week 156]), there were LS mean decreases from Baseline in weight and BMI in both treatment groups, with a slightly larger decrease in the aliskiren compared to the enalapril treatment group.
Croatian: došlo do smanjenja u srednjim vrijednostima (dobivenim metodom najmanjih kvadrata) u odnosu na početne vrijednosti težine i BMI-a u obje liječene skupine, s blago većim smanjenjem u skupini liječenoj aliskirenom u usporedbi sa skupinom liječenom enalaprilom.
English: Name and address of the manufacturer(s) responsible for batch release Noden Pharma DAC
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Noden Pharma DAC
English: It is not recommended in patients with severe renal impairment (glomerular filtration rate (GFR) < 30 ml/min/1.73 m2).
Croatian: Ne preporučuje se bolesnicima s teškim oštećenjem bubrežne funkcije (brzina glomerularne filtracije (GFR) <30 ml/min/1,73 m2).
English: Rasilez 150 mg film-coated tablets Rasilez 300 mg film-coated tablets
Croatian: Rasilez 150 mg filmom obložene tablete Rasilez 300 mg filmom obložene tablete
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 90 film-coated tablets
Croatian: 7 filmom obloženih tableta 14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 56 filmom obloženih tableta 90 filmom obloženih tableta
English: Unit packs containing 7, 14, 28, 30, 50 or 56 tablets.
Croatian: Jedinična pakiranja koja sadrže 7, 14, 28, 30, 50 ili 56 tableta.
English: Renal dysfunction
Croatian: Disfunkcija bubrega
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 84 (3 packs of 28) film-coated tablets Multipack: 98 (2 packs of 49) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets
Croatian: OBLIK I SADRŽAJ Višestruko pakiranje: 84 (3 pakiranja od 28) filmom obložene tablete Višestruko pakiranje: 98 (2 pakiranja od 49) filmom obloženih tableta Višestruko pakiranje: 280 (20 pakiranja od 14) filmom obloženih tableta
English: (95.4% Confidence Interval: 0.987, 1.218, 2-sided p=0.0787).
Croatian: Završni rezultati ispitivanja pokazali su omjer hazarda za primarni ishod od 1,097 u korist placeba (95,4% interval pouzdanosti: 0,987, 1,218, 2-strani p=0,0787).
English: It is not recommended in patients with severe renal impairment (GFR < 30 ml/min/1.73 m2).
Croatian: Ne preporučuje se u bolesnika s teškim oštećenjem bubrežne funkcije (GFR <30 ml/min/1,73 m2).
English: Digoxin and verapamil bioavailability may be slightly decreased by Rasilez.
Croatian: Rasilez može blago smanjiti bioraspoloživost digoksina i verapamila.
English: Co-administration of aliskiren with either metformin (↓28%), amlodipine (↑29%) or cimetidine
Croatian: Istodobna primjena aliskirena bilo s metforminom (↓28%), amlodipinom (↑29%) ili cimetidinom (↑19%) rezultirala je promjenom Cmax ili AUC-u Rasileza između 20% i 30%.
English: Pharmacokinetic interaction with other medicinal products Compounds that have been investigated in clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate and hydrochlorothiazide.
Croatian: atenolol, celekoksib, pioglitazon, alopurinol, izosorbid-5-mononitrat i hidroklorotiazid.
English: angioedema without any known cause.
Croatian: angioedem tijekom uzimanja aliskirena. nasljedni angioedem. angioedem nepoznatog uzroka.
English: Unit packs containing 14, 28, 30, 50, 56, 90 or 98 tablets.
Croatian: Jedinična pakiranja koja sadrže 14, 28, 30, 50, 56, 90 ili 98 tableta.
English: Multipacks containing 84 (3x28), 90 (3x30), 98 (2x49) or 280 (20x14) tablets.
Croatian: Višestruka pakiranja koja sadrže 84 (3x28), 90 (3x30), 98 (2x49) ili 280 (20x14) tableta.
English: What Rasilez looks like and contents of the pack Rasilez 150 mg film-coated tablets are light-pink, biconvex round tablets, imprinted “IL” on one side and “NVR” on the other side.
Croatian: Rasilez 150 mg filmom obložene tablete su svijetloružičaste, bikonveksne, okrugle tablete, s utisnutom oznakom „IL“ na jednoj i „NVR“ na drugoj strani.
English: Following intravenous administration, the mean plasma clearance is approximately
Croatian: Nakon intravenske primjene srednja vrijednost klirensa iz plazme je približno 9 l/h.
English: Hypotension Respiratory, thoracic and mediastinal disorders Uncommon:
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Manje često:
English: PA/Alu/PVC - Alu blisters:
Croatian: SADRŽI PA/AL/PVC BLISTERE
English: Rasilez 300 mg film-coated tablets Each film-coated tablet contains 300 mg aliskiren (as hemifumarate).
Croatian: Rasilez 300 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 300 mg aliskirena (u obliku aliskirenhemifumarata).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX) CONTAINING PA/ALU/PVC BLISTERS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU SREDNJA KUTIJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA) KOJA SADRŽI PA/AL/PVC BLISTERE
English: Multipacks containing 84 (3x28), 98 (2x49) or 280 (20x14) tablets.
Croatian: Višestruka pakiranja koja sadrže 84 (3x28), 98 (2x49) ili 280 (20x14) tableta.
English: Unit packs containing 7, 14, 28, 30, 50, 56 or 90 tablets.
Croatian: Jedinična pakiranja koja sadrže 7, 14, 28, 30, 50, 56 ili 90 tableta.
English: Light-red, biconvex, ovaloid tablet, imprinted “IU” on one side and “NVR” on the other side.
Croatian: Svijetlocrvena, bikonveksna, ovalna tableta, s utisnutom oznakom „IU“ na jednoj i „NVR“ na drugoj strani.
English: 49 x 1 film-coated tablets.
Croatian: Ne prodaje se zasebno. 49 x 1 filmom obloženih tableta.
English: What Rasilez contains - The active substance is aliskiren (as hemifumarate).
Croatian: - Djelatna tvar je aliskiren (u obliku aliskirenhemifumarata).
English: Anaphylactic reactions, hypersensitivity reactions
Croatian: Reakcije preosjetljivosti uključujući anafilaktičke reakcije i angioedem
English: Although aliskiren has known local (gastrointestinal tract) irritation potential, safety margins obtained in humans at the dose of 300 mg during a study in healthy volunteers were considered to be appropriate at 9-11-fold based on faecal concentrations or 6-fold based on mucosa concentrations in comparison with 250 mg/kg/day in the rat carcinogenicity study.
Croatian: 300 mg, odgovaraju 9-11 puta većoj dozi na temelju koncentracija u stolici, ili 6 puta većoj dozi na temelju koncentracija u sluznici, u usporedbi s 250 mg/kg/dan u ispitivanju kancerogenosti u štakora.
English: Light-pink, biconvex, round tablet, imprinted “IL” on one side and “NVR” on the other side.
Croatian: Svijetloružičasta, bikonveksna, okrugla tableta, s utisnutom oznakom „IL“ na jednoj i „NVR“ na drugoj strani.
English: P-gp interactions
Croatian: Istodobna primjena zahtijeva oprez P-gp interakcije
English: At the end of this extension study, changes in msSBP from baseline were similar with aliskiren compared to enalapril (-7.63 mmHg vs. -7.94 mmHg) in the full analysis set.
Croatian: Body Mass Index) većim ili jednakim 95-oj percentili za dob i spol.Na kraju ovog nastavka ispitivanja, promjene u srednjoj vrijednosti sistoličkog krvnog tlaka u sjedećem položaju u odnosu na početne vrijednosti bile su slične za aliskiren u usporedbi s enalaprilom (-7,63 mmHg naspram -7,94 mmHg) koristeći potpuni skup podataka za analizu.
English: Rasilez 300 mg film-coated tablets
Croatian: Rasilez 300 mg filmom obložene tablete
English: Dizziness Ear and labyrinth disorders Not known:
Croatian: Poremećaji uha i labirinta
English: Rasilez 150 mg film-coated tablets - Each tablet contains 150 mg aliskiren (as hemifumarate).
Croatian: Rasilez 150 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 150 mg aliskirena (u obliku aliskirenhemifumarata).
English: aliskiren at doses of 75 mg, 150 mg and 300 mg provided statistically significant superior reduction in blood pressure (both systolic and diastolic) when compared to placebo.
Croatian: U 8-tjednom ispitivanju u kojem je sudjelovalo 754 hipertenzivnih starijih (≥65 godina) i vrlo starih bolesnika (30% ≥75 godina) aliskiren u dozama od 75 mg, 150 mg i 300 mg dovodio je do statistički značajnog superiornog sniženja krvnog tlaka (i sistoličkog i dijastoličkog) u usporedbi s placebom.
English: Rasilez 150 mg film-coated tablets
Croatian: Rasilez 150 mg filmom obložene tablete
English: Dual blockade of the RAAS with aliskiren, ARBs or ACEIs Clinical trial data has shown that dual blockade of the RAAS through the combined use of ACEIs, ARBs or aliskiren is associated with a higher frequency of adverse events such as hypotension, stroke, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Croatian: Podaci iz kliničkih ispitivanja pokazali su da je dvostruka blokada RAAS-a kombiniranom primjenom ACEI-a, ARB-a ili aliskirena povezana s većom učestalošću štetnih događaja kao što su hipotenzija,
English: Black iron oxide (E 172) Red iron oxide (E 172)
Croatian: A magnezijev stearat mikrokristalična celuloza povidon K-30 koloidni bezvodni silicijev dioksid hipromeloza supstitucijski tip 2910 (3 mPa·s) makrogol 4000 talk crni željezov oksid (E 172) crveni željezov oksid (E 172) titanijev dioksid (E 171)
English: NAME OF THE MEDICINAL PRODUCT Rasilez 300 mg film-coated tablets aliskiren
Croatian: Rasilez 300 mg filmom obložene tablete aliskiren
English: NAME OF THE MEDICINAL PRODUCT Rasilez 150 mg film-coated tablets aliskiren
Croatian: Rasilez 150 mg filmom obložene tablete aliskiren
English: hereditary angioedema.
Croatian: I i angiotenzina II.
English: through height and weight measurement, with added neurocognitive and renal function evaluations as follow-up measures performed only in patients with secondary hypertension (19 patients: 9 previously treated with aliskiren and 10 previously treated with enalapril).
Croatian: do 17 godina s primarnom ili sekundarnom hipertenzijom, bili su uključeni u 52 do 104 tjedna neintervencijskog opservacijskog nastavka ispitivanja bez terapije oblikovanog za procjenu dugoročnog rasta i razvoja, mjerenjem težine i visine, s dodatnim procjenama neurokognitivne i bubrežne funkcije kao mjera praćenja provedenih samo u bolesnika sa sekundarnom hipertenzijom (19 bolesnika: 9 prethodno liječenih aliskirenom i 10 prethodno liječenih enalaprilom).
English: Co-administration of grapefruit juice with aliskiren 150 mg resulted in a 61% decrease in aliskiren AUC and co-administration with aliskiren 300 mg resulted in a 38% decrease in aliskiren AUC.
Croatian: Istodobna primjena soka od grejpa s aliskirenom150 mg rezultirala je smanjenjem AUC-a aliskirena za 61%,
English: Investigations Common:
Croatian: Tablični popis nuspojava:
English: Crospovidone, type A
Croatian: Krospovidon tip
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON BOX FOR UNIT PACK CONTAINING PCTFE/PVC BLISTERS
Croatian: KUTIJA JEDINIČNOG PAKIRANJA KOJA SADRŽI PCTFE/PVC BLISTERE
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/039
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/405/039
English: Aliskiren
Croatian: Varfarin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/405/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/017
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/405/017
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/029
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/405/029
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/031
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/405/031
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/011
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/405/011
English: - if you have experienced the following forms of angioedema (difficulties in breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue): angioedema when taking aliskiren.
Croatian: Ako mislite da biste mogli biti alergični, obratite se liječniku za savjet. - ako ste imali bilo koji od sljedećih oblika angioedema (teškoće pri disanju ili gutanju, ili oticanje lica, ruku i nogu, očiju, usnica i/ili jezika):
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/021
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/405/021
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/007
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/405/007
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 300 mg aliskiren (as hemifumarate).
Croatian: Jedna filmom obložena tableta sadrži 300 mg aliskirena (u obliku aliskirenhemifumarata).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 150 mg aliskiren (as hemifumarate).
Croatian: Jedna filmom obložena tableta sadrži 150 mg aliskirena (u obliku aliskirenhemifumarata).
English: In a post-authorisation observational study, the co-administration of aliskiren with ACEIs or ARBs has been associated with an increased risk of angioedema.
Croatian: ARB-ima bila je povezana s povećanim rizikom od angioedema.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR UNIT PACK CONTAINING PA/ALU/PVC BLISTERS
Croatian: KUTIJA JEDINIČNOG PAKIRANJA KOJA SADRŽI PA/AL/PVC BLISTERE
English: Date of first authorisation: 17 July 2015.
Croatian: Datum prvog odobrenja: 17. srpnja 2015
English: It is advised not to drink alcohol while taking Pregabalin Zentiva.
Croatian: Preporučuje se da ne pijete alkohol dok uzimate Pregabalin Zentiva.
English: If you are an elderly patient (over 65 years of age), you should take Pregabalin Zentiva normally except if you have problems with your kidneys.
Croatian: Ako ste bolesnik u starijoj dobi (iznad 65 godina), Pregabalin Zentiva trebate uzimati normalno, osim ako imate problema s bubrezima.
English: Talk to your doctor or pharmacist before taking Pregabalin Zentiva.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Pregabalin Zentiva.
English: B-dul Theodor Pallady nr.50, sector 3, Bucharest, cod 032266 Romania
Croatian: B-dul Theodor Pallady nr.50, sector 3, Bukurešt, cod 032266 Rumunjska
English: Pregabalin Zentiva and certain other medicines may influence each other (interaction).
Croatian: Pregabalin Zentiva i neki drugi lijekovi mogu djelovati jedni na druge (interakcija).
English: Your doctor will tell you to take Pregabalin Zentiva either twice or three times a day.
Croatian: Liječnik će Vam reći da uzmete Pregabalin Zentiva dva puta ili tri puta na dan.
English: Do not take Pregabalin Zentiva • if you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section
Croatian: Nemojte uzimati Pregabalin Zentiva • ako ste alergični na pregabalin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: What Pregabalin Zentiva is and what it is used for What you need to know before you take Pregabalin Zentiva How to take Pregabalin Zentiva Possible side effects
Croatian: Što je Pregabalin Zentiva i za što se koristi Što morate znati prije nego počnete uzimati Pregabalin Zentiva Kako uzimati Pregabalin Zentiva Moguće nuspojave
English: Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics; ATC code: N03AX16.
Croatian: Farmakoterapijska skupina: Antiepileptici, ostali antiepileptici, ATK oznaka: N03AX16
English: Pregabalin may potentiate the effects of ethanol and lorazepam.
Croatian: Pregabalin može pojačati učinke etanola i lorazepama.
English: If you take more Pregabalin Zentiva than you should Call your doctor or go to the nearest hospital emergency unit immediately.
Croatian: Ako uzmete više lijeka Pregabalin Zentiva nego što ste trebali Odmah nazovite svog liječnika ili otiđite u hitnu službu najbliže bolnice.
English: It is important to take your Pregabalin Zentiva hard capsules regularly at the same time each day.
Croatian: Važno je da Pregabalin Zentiva tvrde kapsule uzimate redovito, svakoga dana u isto vrijeme.
English: Pregabalin Zentiva may be taken with or without food.
Croatian: Pregabalin Zentiva može se uzimati s hranom ili bez nje.
English: Continue taking Pregabalin Zentiva until your doctor tells you to stop.
Croatian: Nastavite uzimati Pregabalin Zentiva dok Vam liječnik ne kaže da prestanete.
English: What Pregabalin Zentiva is and what it is used for
Croatian: Što je Pregabalin Zentiva i za što se koristi
English: Pregabalin Zentiva is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Croatian: Pregabalin Zentiva nije namijenjen za samostalnu primjenu, nego se uvijek mora uzimati u kombinaciji s drugim antiepileptičkim lijekovima.
English: Pregabalin Zentiva with food, drink and alcohol Pregabalin Zentiva hard capsules may be taken with or without food.
Croatian: Pregabalin Zentiva s hranom, pićem i alkoholom Pregabalin Zentiva tvrde kapsule mogu se uzimati s hranom ili bez nje.
English: Pregabalin Zentiva should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor.
Croatian: Pregabalin Zentiva se ne smije uzimati tijekom trudnoće ili dojenja, osim ako Vam liječnik nije rekao drugačije.
English: The safety and efficacy of pregabalin in children below the age of 12 years and in adolescents (12 - 17 years of age) have not been established.
Croatian: Sigurnost i djelotvornost pregabalina u djece mlađe od 12 godina i adolescenata (12-17 godina) nisu ustanovljene.
English: Other medicines and Pregabalin Zentiva
Croatian: Drugi lijekovi i Pregabalin Zentiva
English: The AUC was lower by 30% in paediatric patients below a weight of 30 kg due to an increased body weight adjusted clearance of 43% for these patients in comparison to patients weighing ≥30 kg.
Croatian: AUC je bio niži za 30% u pedijatrijskih bolesnika tjelesne težine manje od 30 kg zbog povećanog klirensa prilagođenog tjelesnoj težini od 43% za te bolesnike u odnosu na bolesnike tjelesne težine ≥30 kg.
English: What you need to know before you take Pregabalin Zentiva
Croatian: Što morate znati prije nego počnete uzimati Pregabalin Zentiva
English: Pregabalin Zentiva may be taken with oral contraceptives.
Croatian: Pregabalin Zentiva može se uzimati s oralnim kontraceptivima.
English: If you have the impression that the effect of Pregabalin Zentiva is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako Vam se čini da je djelovanje lijeka Pregabalin Zentiva prejako ili preslabo, porazgovarajte sa svojim liječnikom ili ljekarnikom.
English: What Pregabalin Zentiva looks like and contents of the pack
Croatian: Kako Pregabalin Zentiva izgleda i sadržaj pakiranja
English: If while taking Pregabalin Zentiva you notice decreased urination, you should tell your doctor as stopping the medicine may improve this.
Croatian: Ako tijekom uzimanja lijeka Pregabalin Zentiva primijetite da manje mokrite, morate o tome obavijestiti svog liječnika jer se prekidom primjene lijeka to može poboljšati.
English: Pregabalin Zentiva 25 mg hard capsules are packed into alu/alu (OPA/alu/PVC/alu) blisters as primary packaging.
Croatian: Pregabalin Zentiva 25 mg tvrde kapsule zapakirane su u alu/alu (OPA/alu/PVC/alu) blistere kao primarno pakiranje.
English: How to store Pregabalin Zentiva Contents of the pack and other information
Croatian: Kako čuvati Pregabalin Zentiva Sadržaj pakiranja i druge informacije
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 (vidjeti Tablicu 1).
English: Take your box of Pregabalin Zentiva hard capsules with you.
Croatian: Uzmite sa sobom kutiju Pregabalin Zentiva tvrdih kapsula.
English: Your doctor will prescribe Pregabalin Zentiva for you to help treat your epilepsy when your current treatment is not controlling your condition.
Croatian: Liječnik će Vam propisati Pregabalin Zentiva za liječenje epilepsije kada lijekovi koje ste do sada uzimali bolest ne drže pod kontrolom.