FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of levofloxacin administered by inhalation have not been studied in the elderly.
Croatian: Farmakokinetika levofloksacina primijenjenog inhalacijom nije ispitivana u starijih bolesnika.
English: Blood alkaline phosphatase increased*, Electrocardiogram QT prolonged*, Eosinophil count increased*, Platelet count decreased*
Croatian: abnormalni rezultati jetrenih proba, porast alkalne fosfataze u krvi*, elektrokardiografsko produljenje QT-intervala*, povišen broj eozinofila*, smanjen broj trombocita*
English: Hepatitis*, Hyperbilirubinaemia*
Croatian: Poremećaji jetre i žuči hepatitis*, hiperbilirubinemija*
English: One ampoule contains levofloxacin hemihydrate equivalent to 240 mg of levofloxacin.
Croatian: Jedna ampula sadrži levofloksacin u obliku hemihidrata što odgovara 240 mg levofloksacina.
English: Common: may affect up to 1 in 10 people - Fungal infection around vagina - Insomnia or difficulty sleeping - Headache - Dizziness - Ringing or noise in the ears (tinnitus) - Change to the voice - Feeling and being sick - Abdominal pain - Diarrhoea - Constipation - Rash - Joint or muscle pain - Fever - Abnormal blood test results (increased levels of certain liver enzymes or bilirubin in the blood,
Croatian: Često: mogu se javiti kod najviše 1 na 10 osoba - gljivične infekcije oko rodnice - nesanica ili poremećaj sna - glavobolja - omaglica - zujanje ili šum u ušima (tinnitus) - promjena glasa - osjećaj mučnine - abdominalna bol - proljev - zatvor - osip - bol u zglobovima ili mišićima - bol u mišićima - vrućica - poremećeni nalazi krvnih pretraga (povišene razine određenih enzima ili bilirubina u krvi,
English: Rare (≥ 1/10,000 to
Croatian: Rijetko (≥ 1/10 000 i < 1/1000)
English: FEV1 Relative change from Baseline to Day 28 of Cycle 3
Croatian: Relativna promjena FEV1 od početnih vrijednosti do 28. dana 3. ciklusa
English: How to store Quinsair
Croatian: Kako čuvati Quinsair
English: The Manufacturer's Instructions for Use of the Zirela Nebuliser System should be reviewed prior to the first use of Quinsair.
Croatian: Prije prve primjene Quinsaira potrebno je proučiti upute proizvođača za uporabu naprave za inhalaciju Zirela Nebuliser System.
English: In addition, the pharmacokinetics of weight-based doses of levofloxacin administered by inhalation once daily for 14 days in paediatric patients with CF (≥ 6 to < 12 years old, n = 14 and ≥ 12 to < 17 years old, n = 13) were evaluated in Study 206.
Croatian: Nadalje, u Ispitivanju 206 ispitivana je farmakokinetika levofloksacina u dozama prema tjelesnoj težini primijenjenih inhalacijom jedan puta na dan tijekom 14 dana u pedijatrijskih bolesnika s CF (u dobi ≥ 6 do < 12 godina, n = 14 i u dobi ≥ 12 do < 17 godina, n = 13).
English: ≥ 12 to < 18 years, n (%) ≥ 18 years, n (%) Baseline mean (SD) Relative change from Baseline to Day 28
Croatian: ≥ 12 do < 18 godina, n ≥ 18 godina, n (%) Srednja početna vrijednost (SD)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING FOIL LAMINATE SACHET CONTAINING 4 AMPOULES
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU VREĆICA OD VIŠESLOJNE FOLIJE KOJA SADRŽI 4 AMPULE
English: If acute, symptomatic bronchoconstriction occurs after receiving Quinsair, patients may benefit from the use of a short-acting inhaled bronchodilator prior to subsequent doses (see sections 4.2 and 4.4).
Croatian: Ako nakon primjene Quinsaira nastupi akutna, simptomatska bronhokonstrikcija, bolesnicima može koristiti primjena inhalacijskog bronhodilatatora kratkog djelovanja prije sljedeće doze (vidjeti dijelove 4.2 i 4.4).
English: - Liver problems.
Croatian: - probleme s jetrom.
English: Vulvovaginal mycotic infection
Croatian: Infekcije i infestacije vulvovaginalna gljivična infekcija oralna gljivična infekcija
English: N = 189 131 days
Croatian: N = 189 131 dan
English: Tell your doctor if you are taking any of the following medicines: - Vitamin K antagonists such as warfarin (used to prevent blood clots).
Croatian: Obavijestite svog liječnika ako uzimate neki od sljedećih lijekova: - Antagoniste vitamina
English: Get urgent medical treatment immediately if you notice a severe allergic reaction after inhaling Quinsair.
Croatian: Ako nakon inhalacije Quinsaira primijetite tešku alergijsku reakciju, odmah potražite hitnu medicinsku pomoć.
English: Taking Quinsair at the same time as these medicines could increase your risk of a fit (seizure).
Croatian: Istodobno korištenje Quinsaira i tih lijekova može Vam povećati rizik za napadaje.
English: 56 (14 sachets of 4) ampoules
Croatian: 56 ampula (14 vrećica po 4 ampule)
English: Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors.
Croatian: U bolesnika koji primaju kinolone i fluorokinolone zabilježeni su vrlo rijetki slučajevi dugotrajnih (koje traju mjesecima ili godinama), onesposobljavajućih i potencijalno ireverzibilnih ozbiljnih nuspojava koje zahvaćaju različite organske sustave, a ponekad istodobno i više njih (mišićno-koštani, živčani, psihijatrijski i osjetilni poremećaji), bez obzira na dob bolesnika i prethodno prisutne čimbenike rizika.
English: Squeeze all of the contents of one ampoule into the medicine reservoir of the Zirela Nebuliser Handset.
Croatian: Istisnite sadržaj cijele ampule u spremnik naprave za inhalaciju Zirela Nebuliser Handset.
English: ciprofloxacin or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6) - if you have ever had a problem with your tendons (inflammation of a tendon or a ruptured tendon) during treatment with a quinolone or fluoroquinolone antibiotic - if you suffer from epilepsy - if you are pregnant or breast-feeding
Croatian: Nemojte primjenjivati Quinsair: - ako ste alergični na levofloksacin, na bilo koji drugi kinolonski antibiotik, poput moksifloksacina, ciprofloksacina ili ofloksacina, ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako ste ikad imali problema s tetivama (upalu tetive ili puknuće tetive) tijekom liječenja kinolonskim ili fluorokinolonskim antibiotikom - ako bolujete od padavice - ako ste trudni ili dojite
English: The effects of renal impairment on the pharmacokinetics of levofloxacin administered by inhalation have not been studied.
Croatian: Učinci oštećenja bubrega na farmakokinetiku levofloksacina primijenjenog inhalacijom još nisu ispitani.
English: Psychotic reactions (e.g. hallucination, paranoia), Agitation, Abnormal dreams, Nightmares
Croatian: konfuzno stanje, nervoza psihotičke reakcije (npr. halucinacije, paranoja) agitacija, neuobičajeni snovi, noćne more psihotični poremećaji sa samougrožavajućim ponašanjem uključujući suicidalne ideacije ili pokušaj samoubojstva
English: You may develop diarrhoea during or after your treatment with Quinsair.
Croatian: Tijekom ili nakon liječenja Quinsairom može se javiti proljev.
English: Anaphylactic shock, Anaphylactoid shock
Croatian: Poremećaji imunološkog sustava angioedem anafilaktički šok anafilaktoidni šok
English: LS mean [95% CI]: 1.86 [-0.66, 4.39] c
Croatian: N = 189 2,24 (1,019) b srednja LS [95% CI]: 1,86 [-0,66, 4,39] c
English: Erythema multiforme, Photosensitivity reaction,
Croatian: Stevens-Johnsonov sindrom, multiformni eritem, fotosenzitivna reakcija, leukocitoklastički vaskulitis, stomatitis
English: CI = Confidence interval; FEV1 = forced expiratory volume in 1 second; ITT = intent to treat (all patients randomised); P = P value; SD = standard deviation; SE = standard error; ANCOVA = analysis of covariance.
Croatian: CI = interval pouzdanosti; FEV1 = forsirani ekspiratorni volumen u 1 sekundi; ITT = namjera liječenja (svih randomiziranih bolesnika); P = P vrijednost; SD = standardna devijacija; SE = standardna pogreška; ANCOVA = analiza kovarijance. a ANCOVA s uvjetima za liječenje, regiju, dob (16 do18 godina, > 18 godina), i početna vrijednost postotka predviđene vrijednosti FEV1 kao kvartile.
English: The apparent total body clearance and apparent volume of distribution were not affected by the race of the subjects.
Croatian: Rasa ispitanika nije imala utjecaja na prividni ukupni klirens i prividni volumen distribucije.
English: N = 170 2.35 (1.025) b
Croatian: N = 170 2,35 (1,025) b srednja LS [95% CI]:
English: Each ml of nebuliser solution contains levofloxacin hemihydrate equivalent to 100 mg of levofloxacin.
Croatian: Jedan ml otopine za atomizator sadrži levofloksacin u obliku hemihidrata što odgovara 100 mg levofloksacina.
English: - Diarrhoea
Croatian: - dijabetes
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Quinsair 240 mg nebuliser solution
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Quinsair 240 mg otopina za atomizator levofloksacin
English: Quinsair should not be used with any other type of handset or aerosol head.
Croatian: Quinsair se ne smije koristiti s nijednim drugim tipom sustava za inhalaciju.
English: Press down and turn the cap clockwise as far as it will go.
Croatian: Pritisnite prema dolje i zakrenite poklopac do kraja u smjeru kazaljki na satu.
English: Quinsair 240 mg nebuliser solution Levofloxacin
Croatian: Quinsair 240 mg otopina za atomizator levofloksacin
English: The safety and efficacy of Quinsair in children aged ˂ 18 years old have not yet been established.
Croatian: Sigurnost i djelotvornost Quinsaira u djece u dobi
English: Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones.
Croatian: U bolesnika koji su primali kinolone i fluorokinolone zabilježeni su slučajevi senzoričke i senzomotoričke polineuropatije s posljedičnom parestezijom, hipoestezijom, disestezijom ili slabošću.
English: Toxic epidermal necrolysis,
Croatian: Poremećaji kože i potkožnog tkiva hiperhidroza toksična epidermalna nekroliza,
English: The pharmacokinetics of levofloxacin following inhalation of Quinsair 240 mg twice daily were investigated in paediatric patients with CF aged 12 years and older and weighing ≥ 30 kg. A population PK model based on sparse sampling determined that levofloxacin serum concentrations were comparable between paediatric and adult patients following 28 days of treatment.
Croatian: Farmakokinetika levofloksacina nakon inhalacije Quinsaira 240 mg dva puta na dan ispitivana je na pedijatrijskim bolesnicima s CF u dobi od 12 godina i starijih i s tjelesnom težinom ≥ 30 kg.
English: Common (≥ 1/100 to < 1/10)
Croatian: Vrlo često (≥ 1/10) Često (≥ 1/100 i < 1/10)
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava anemija*, neutropenija*
English: Stomatitis
Croatian: Disglikemija
English: NAME OF THE MEDICINAL PRODUCT Quinsair 240 mg nebuliser solution
Croatian: NAZIV LIJEKA Quinsair 240 mg otopina za atomizator
English: Do not put other medicinal products into the Zirela Nebuliser Handset.
Croatian: U napravu za inhalaciju Zirela Nebuliser Handset ne stavljajte druge lijekove.
English: The controller will ‘beep' once and the status light will turn green. After a few seconds, an aerosol mist will begin to flow into the aerosol chamber of the Zirela Nebuliser Handset.
Croatian: Nakon nekoliko sekundi maglica aerosola će početi proticati kroz komoru naprave za inhalaciju Zirela Nebuliser Handset.
English: Very rare cases of long lasting (up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors.
Croatian: S primjenom kinolonskih i fluorokinolonskih antibiotika povezuju se vrlo rijetki slučajevi dugotrajnih (koje traju čak mjesecima ili godinama) ili trajnih nuspojava, kao što su upala tetive, puknuće tetive, bol u zglobovima, bol u udovima, otežano hodanje, abnormalni osjeti poput bockanja, trnaca, škakljanja, žarenja, utrnulosti ili boli (neuropatija), depresija, umor, poremećaji spavanja, narušeno pamćenje, kao i oštećenje sluha, vida te okusa i njuha, koje u nekim slučajevima nastaju neovisno o prethodno prisutnim čimbenicima rizika.
English: A total of 189 patients were randomised to Quinsair 240 mg twice daily (≥ 18 years, n = 170; ≥ 12 to < 18 years old, n = 19) and 93 were randomised to TIS (≥ 18 years, n = 84; ≥ 12 to < 18 years old, n = 9).
Croatian: ≥ 12 do < 18godina, n = 19) i 93 bolesnika je randomizirano u skupinu koja je primala TIS (u dobi ≥ 18 godina, n = 84; i u dobi ≥ 12 do < 18 godina, n = 9).
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja alergijski pneumonitis
English: You should not take fluoroquinolone/quinolone antibacterial medicines, including Quinsair, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone.
Croatian: Ako ste ikad prije imali neku ozbiljnu nuspojavu kad ste uzimali kinolon ili fluorokinolon, ne smijete uzimati fluorokinolonske/kinolonske antibiotike, što uključuje i Quinsair.
English: Baseline to Day 28 of Cycle 1
Croatian: Promjene od početnih vrijednosti do 28. dana 1. ciklusa
English: What Quinsair looks like and contents of the pack Quinsair is a clear, pale yellow nebuliser solution.
Croatian: Kako Quinsair izgleda i sadržaj pakiranja
English: General disorders and administration site conditions1
Croatian: Opći poremećaji i reakcije na mjestu primjene1
English: Cycles 1 to 6), the LS Mean change in FEV1 percent predicted ranged between 3.6% to 4.6% except in Cycle 6, where it was close to baseline (-0.15%).
Croatian: U podskupini bolesnika koji su primali Quinsair tijekom čitave središnje faze i produžene faze ispitivanja (tj. od 1. do 6. ciklusa terapije), srednja LS promjena postotka predviđene vrijednosti FEV1 kretala se između 3,6% i 4,6%, osim u 6. ciklusu kada je bila slična početnim vrijednostima (-0.15%).
English: Cardiac disorders
Croatian: Srčani poremećaji tahikardija*
English: - Do not put any medicines other than Quinsair in the Zirela Nebuliser Handset.
Croatian: - U napravu za inhalaciju Zirela Nebuliser Handset ne stavljajte druge lijekove osim Quinsaira.
English: FEV1 Relative change from Baseline to Day 28 of Cycle 2
Croatian: Sekundarne krajnje točke ishoda: Relativna promjena FEV1 od početnih vrijednosti do 28. dana 2. ciklusa
English: If this happens, stop using Quinsair and contact your doctor immediately.
Croatian: Ako se to dogodi, odmah se obratite svom liječniku.
English: The half-life of levofloxacin following inhalation of Quinsair is approximately 5 to 7 hours.
Croatian: Poluvijek levofloksacina nakon inhalacije Quinsaira iznosi oko
English: Nebuliser Solution Levofloxacin
Croatian: Otopina za atomizator levofloksacin
English: Benign intracranial hypertension
Croatian: Krvožilni poremećaji hipotenzija
English: N = 166 1.98 (1.049) b
Croatian: N = 166 1,98 (1,049) b srednja LS [95% CI]:
English: Adare Pharmaceuticals S.r.l.
Croatian: Chiesi Pharmaceuticals B.V.
English: Headache, Dizziness*
Croatian: disgeuzija glavobolja, omaglica*
English: PHARMACEUTICAL FORM Nebuliser solution.
Croatian: OBLIK Otopina za atomizator.
English: Eye disorders1
Croatian: Poremećaji oka1
English: Posology
Croatian: Oznaka
English: Changes in bronchial secretions (volume and viscosity)*, Haemoptysis*
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja kašalj / produktivni kašalj dispneja, promjene u bronhalnoj sekreciji (volumena i viskoziteta)*, hemoptiza*
English: Chiesi Bulgaria EOOD Teл.
Croatian: Magyarország Chiesi Hungary Kft.
English: Clear, pale yellow solution.
Croatian: Bistra, blijedožuta otopina.
English: Ampoule
Croatian: Doziranje
English: Retching, Dyspepsia*, Flatulence*
Croatian: dizanje želuca, dispepsija*, vjetrovi*
English: Haemoptysis
Croatian: Ampula
English: 0.65 ml (200 µg/ml) 4 pre-filled pens
Croatian: 0,65 ml (200 µg/ml) 4 napunjene štrcaljke
English: 0.65 ml (200 µg/ml) 4 pre-filled syringes with needle guard
Croatian: 0,65 ml (200 µg/ml) 4 štrcaljke s uloškomsa štitnikom za iglu
English: 0.65 ml (200 µg/ml) 1 pre-filled syringe with needle guard
Croatian: 0,65 ml (200 µg/ml) 1 štrcaljka s uloškom sa štitnikom za iglu
English: Aripiprazole Mylan Pharma is available as tablets (5, 10, 15 and 30 mg) and can only be obtained with a prescription.
Croatian: Lijek Aripiprazole Mylan Pharma dostupan je u tabletama (5, 10, 15 i 30 mg), a izdaje se samo na recept.
English: The name of the medicine was changed to Aripiprazole Mylan Pharma on 3 June 2016.
Croatian: Naziv lijeka izmijenjen je u Aripiprazole Mylan Pharma 3. lipnja 2016.
English: For more information on generic medicines, see the question-andanswer document here.
Croatian: Više informacija o generičkim lijekovima potražite u dokumentu s pitanjima i odgovorima ovdje
English: The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Mylan Pharma is broken down in the body.
Croatian: Dozu treba prilagoditi u bolesnika koji uzimaju druge lijekove, koji mogu utjecati na način razgradnje lijeka Aripiprazole Mylan Pharma u tijelu.
English: In addition, the company that markets Aripiprazole Mylan Pharma will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
Croatian: Nadalje, proizvođač lijeka Aripiprazole Mylan Pharma dostavit će edukacijske materijale koji će se uručiti bolesnicima ili njihovim skrbnicima i liječnicima kako bi se pojasnila sigurna primjena lijeka u bolesnika u dobi između 13 i 17 godina.
English: This is a summary of the European public assessment report (EPAR) for Aripiprazole Mylan Pharma.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Aripiprazole Mylan Pharma.
English: The Committee recommended that Aripiprazole Mylan Pharma be approved for use in the EU.
Croatian: Odbor je preporučio odobrenje lijeka Aripiprazole Mylan Pharma za korištenje u EU-u.
English: Aripiprazole Mylan Pharma is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past.
Croatian: Aripiprazole Mylan Pharma se koristi u odraslih osoba za liječenje umjerenih do ozbiljnih maničnih epizoda i za sprječavanje novih maničnih epizoda u odraslih osoba koje su odgovorile na lijek u prošlosti.
English: Aripiprazole Mylan Pharma is used in patients with the following mental illnesses:
Croatian: Aripiprazole Mylan Pharma koristi se u bolesnika sa sljedećim mentalnim bolestima:
English: This means that Aripiprazole Mylan Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
Croatian: To znači da je Aripiprazole Mylan Pharma sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Mylan Pharma has been shown to have comparable quality and to be bioequivalent to Abilify.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno kako Aripiprazole Mylan Pharma posjeduje usporedivu kakvoću te je bioekvivalentan s lijekom Abilify.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Mylan Pharma, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Aripiprazole Mylan Pharma nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Because Aripiprazole Mylan Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je lijek Aripiprazole Mylan Pharma generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i kod referentnog lijeka.
English: For practical information about using Aripiprazole Mylan Pharma, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Aripiprazole Mylan Pharma bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Aripiprazole Mylan Pharma is used in patients aged 15 years or over;
Croatian: Aripiprazole Mylan Pharma se koristi u bolesnika u dobi od 15 godina ili starijih;
English: Aripiprazole Mylan Pharma is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.
Croatian: Aripiprazole Mylan Pharma se također koristi u razdoblju do 12 tjedana za liječenje umjerenih do ozbiljnih maničnih epizoda u bolesnika u dobi od 13 godina i starijih.
English: What is Aripiprazole Mylan Pharma and what is it used for?
Croatian: Što je Aripiprazole Mylan Pharma i za što se koristi?
English: Aripiprazole Mylan Pharma contains the active substance aripiprazole and is a ‘generic medicine'.
Croatian: Aripiprazole Mylan Pharma sadrži djelatnu tvar aripiprazol i "generički je lijek".
English: The full EPAR and risk management plan summary for Aripiprazole Mylan Pharma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Aripiprazole Mylan Pharma nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Aripiprazole Mylan Pharma pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: What measures are being taken to ensure the safe and effective use of Aripiprazole Mylan Pharma?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Aripiprazole Mylan Pharma?
English: A risk management plan has been developed to ensure that Aripiprazole Mylan Pharma is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Aripiprazole Mylan Pharma.
English: What are the benefits and risks of Aripiprazole Mylan Pharma?
Croatian: Koje su koristi i rizici od lijeka Aripiprazole Mylan Pharma?
English: Because Aripiprazole Mylan Pharma is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify.
Croatian: Budući da je Aripiprazole Mylan Pharma generički lijek, ispitivanja na bolesnicima bila su ograničena na ispitivanja za utvrđivanje da je lijek bioekvivalentan referentnom lijeku Abilify.
English: It is not intended to provide practical advice on how to use Aripiprazole Mylan Pharma.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Aripiprazole Mylan Pharma.
English: Other information about Aripiprazole Mylan Pharma
Croatian: Ostale informacije o lijeku Aripiprazole Mylan Pharma
English: The active substance in Aripiprazole Mylan Pharma, aripiprazole, is an antipsychotic medicine.
Croatian: Aripiprazol, djelatna tvar u lijeku Aripiprazole Mylan Pharma, je antipsihotik.
English: Why is Aripiprazole Mylan Pharma approved?
Croatian: Zašto je lijek Aripiprazole Mylan Pharma odobren?
English: Previously known as Aripiprazole Pharmathen.
Croatian: Ranije poznat pod imenom Aripiprazole
English: Aripiprazole Mylan Pharma aripiprazole
Croatian: Aripiprazole Mylan Pharma1