FrancophonIA/ELRC3.0 huggingface dataset:
English: Over 60kg
Croatian: Više od 60 kg
English: [To be completed nationally, if necessary]
Croatian: [ispunjava se, po potrebi, na nacionalnoj razini]
English: For tablets/capsules/granules
Croatian: Za tablete/kapsule/granule
English: These may be signs of an allergic reaction, which may be severe.
Croatian: To mogu biti znakovi alergijske reakcije, koja može biti teška.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugima lijekovima i drugi oblici interakcije
English: The maximum recommended treatment duration is 5 days.
Croatian: Maksimalno preporučeno trajanje liječenja je 5 dana.
English: - Use in children below 18 years of age
Croatian: - Primjena u djece u dobi ispod 18 godina.
English: If you forget to take {Tradename} Do not take a double dose to make up for a forgotten dose.
Croatian: Ako ste zaboravili uzeti {Zaštićeno ime} Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Anticholinergics and morphine derivatives
Croatian: Antikolinergici i derivati morfina
English: Convulsion especially in epileptic patients
Croatian: Konvulzije, posebno u epileptičkih bolesnika
English: The medicine will normally be given to you by a doctor or a nurse.
Croatian: Lijek će Vam obično dati liječnik ili medicinska sestra.
English: Do not take {Tradename} if any of the above apply to you.
Croatian: Nemojte uzimati {Zaštićeno ime ako se bilo što od toga odnosi na Vas.
English: The dose may be reduced (see section 3).
Croatian: Doza može biti smanjena (pogledajte dio 3).
English: For all preparations
Croatian: Za sve pripravke
English: Your doctor will decide whether or not you should be given this medicine.
Croatian: Vaš će liječnik odlučiti smijete li ili ne smijete dobivati ovaj lijek.
English: Strong CYP2D6 inhibitors
Croatian: Snažni inhibitori CYP2D6
English: All indications (adult patients)
Croatian: Sve indikacije (odrasli bolesnici)
English: 2 What you need to know before you are given {Tradename}
Croatian: Što morate znati prije nego što primite {Zaštićeno ime}
English: Your doctor may perform blood tests to check your blood pigment levels.
Croatian: Vaš liječnik može napraviti krvne pretrage kako bi provjerio razine pigmenta u krvi.
English: A large amount of data on pregnant women (more than 1000 exposed outcomes) indicates no malformative toxicity nor foetotoxicity.
Croatian: Velika količina podataka o trudnicama (više od 1000 izloženih trudnoća) ne upućuje na malformacijsku toksičnost ili fetotoksičnost.
English: If necessary, {Tradename} may be taken during pregnancy.
Croatian: Ako je potrebno, {Zaštićeno ime} se može uzimati u trudnoći.
English: You doctor may prescribe you a treatment for these signs if necessary.
Croatian: Liječnik Vam može po potrebi propisati liječenje za ove simptome.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi drugi lijekovi, ovaj lijek može uzrokovati nuspojave, iako se one neće razviti kod svakoga.
English: The clinical consequence is uncertain.
Croatian: Nisu jasno utvrđene kliničke posljedice.
English: Frequencies are defined using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane na sljedeći način: vrlo često (≥1/10), često (≥1/100, <1/10), manje često (≥1/1.000, <1/100), rijetko (≥1/10.000, <1/1.000), vrlo rijetko (<1/10.000), nije poznato (ne može se procijeniti na osnovi raspoloživih podataka).
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before being given this medicine.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego što uzmete ovaj lijek.
English: It contains a medicine called “metoclopramide”.
Croatian: Sadrži lijek koji se zove «metoklopramid».
English: Although the clinical significance is uncertain, patients should be monitored for adverse reactions.
Croatian: Iako klinički značaj nije siguran, bolesnike je potrebno pratiti radi mogućih nuspojava.
English: In adults patients
Croatian: U odraslih bolesnika
English: The injectable treatment duration should be as short as possible and transfer to oral or rectal treatment should be made as soon as possible.
Croatian: Liječenje injiciranjem lijeka treba trajati što je kraće moguće, a prijelaz na oralno ili rektalno liječenje potrebno je izvršiti čim je prije moguće.
English: These may be signs of a condition called neuroleptic malignant syndrome.
Croatian: To mogu biti znakovi stanja koje se naziva neuroleptički maligni sindrom.
English: Metoclopramide increases cyclosporine bioavailability (Cmax by 46% and exposure by 22%).
Croatian: Metoklopramid povećava bioraspoloživost ciklosporina (Cmax za 46% i izloženost za 22%).
English: Stop the treatment and talk straight away to your doctor, pharmacist or nurse if you experience one of the following signs while having this medicine: - uncontrollable movements (often involving head or neck).
Croatian: Prekinite liječenje i odmah se javite svom liječniku, ljekarniku ili medicinskoj sestri ako primijetite neki od sljedećih znakova dok uzimate ovaj lijek: nekontrolirani pokreti (često zahvaćaju glavu ili vrat).
English: A symptomatic treatment and a continuous monitoring of the cardiovascular and respiratory functions should be carried out according to clinical status.
Croatian: Potrebno je provesti simptomatsko liječenje i kontinuirano praćenje kardiovaskularne i respiratorne funkcije u skladu s kliničkim statusom.
English: Rare (may affect up to 1 in 1,000 people) confusional state convulsion (especially in patients with epilepsy).
Croatian: Rijetko (mogu se javiti u do 1 na 1000 ljudi) stanje smetenosti konvulzije (posebno u bolesnika s epilepsijom).
English: Very common (may affect more than 1 in 10 people) feeling drowsy.
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 ljudi) osjećaj omamljenosti.
English: {Tradename} is not recommended if you are breast-feeding because metoclopramide passes into breast milk and may affect your baby.
Croatian: {Zaštićeno ime} se ne preporučuje ako dojite jer se metoklopramid izlučuje u majčino mlijeko i može utjecati na dojenče.
English: All indications (paediatric patients aged 1-18 years)
Croatian: Sve indikacije (pedijatrijski bolesnici u dobi od 1 do 18 godina)
English: Metoclopramide should be avoided at the end of pregnancy.
Croatian: Metoklopramid je potrebno izbjegavati na kraju trudnoće.
English: In such cases, metoclopramide should be immediately and permanently discontinued and appropriate measures initiated (such as treatment with methylene blue).
Croatian: U tim je slučajevima potrebno odmah i trajno prekinuti primjenu metoklopramida i uvesti odgovarajuće mjere (kao što je liječenje metilenskim plavilom).
English: This is because some medicines can affect the way {Tradename} works or {Tradename} can affect how other medicines work.
Croatian: To je zato jer određeni lijekovi mogu utjecati na djelovanje {Zaštićeno ime} ili {Zaštićeno ime} može utjecati na djelovanje tih drugih lijekova.
English: Device / instruction for use
Croatian: Uređaj / upute za uporabu
English: Due to pharmacological properties (as other neuroleptics), in case of metoclopramide administration at the end of pregnancy, extrapyramidal syndrome in newborn cannot be excluded.
Croatian: Zbog farmakoloških svojstava (kao i kod drugih neuroleptika), u slučaju primjene metoklopramida na kraju trudnoće ne može se isključiti pojava ekstrapiramidnog sindroma u novorođenčeta.
English: Combination to be taken into account Due to the prokinetic effect of metoclopramide, the absorption of certain drugs may be modified.
Croatian: Kombinacija koju je potrebno uzeti u obzir Zbog prokinetičkog učinka metoklopramida, apsorpcija određenih lijekova može biti promijenjena.
English: Uncontrollable movements (extrapyramidal disorders) may occur in children and young adults.
Croatian: Nekontrolirani pokreti (ekstrapiramidni poremećaji) mogu se javiti u djece i mlađih odraslih.
English: Talk to your doctor if you have liver problems.
Croatian: Razgovarajte sa svojim liječnikom ako imate problema s jetrom.
English: - Itching or skin rashes, swelling of the face, lips or throat, difficulty in breathing.
Croatian: Svrbež kože ili kožni osipi, oticanje lica, usnica ili grla, teškoće s disanjem.
English: Metoclopramide injection may prolong the duration of neuromuscular block (through inhibition of plasma cholinesterase).
Croatian: Injekcija metoklopramida može produljiti trajanje neuromuskularnog bloka (putem inhibicije kolinesteraze u plazmi).
English: For all formulations
Croatian: Za sve formulacije
English: For rectal formulation - you have recently experienced inflammation and/or bleeding from your back passage (anus/rectum) - you are below 18 years of age.
Croatian: Za rektalnu formulaciju ako ste nedavno imali upalu i/ili krvarenje iz završnog dijela debelog crijeva (anusa/rektuma) ako ste mlađi od 18 godina.
English: - Recent history of proctitis or rectal bleeding
Croatian: - Anamneza nedavnog proktitisa ili rektalnog krvarenja.
English: Adverse reactions listed by System Organ Class.
Croatian: Nuspojave navedene po klasi organskih sustava.
English: Do not give {Tradename} to a child less than 1 year of age (see below “Children and adolescents”).
Croatian: Nemojte davati {Zaštićeno ime} djetetu u dobi ispod 1 godine (pogledajte «Djeca i adolescenti» u nastavku teksta).
English: For rectal formulations
Croatian: Za rektalne formulacije
English: This medicine must not be used in children below 1 year of age because of the increased risk of the uncontrollable movements (see above “Do not take {Tradename} if”).
Croatian: Ovaj se lijek ne smije koristiti u djece u dobi ispod 1 godine zbog povećanog rizika od nekontroliranih pokreta (pogledajte iznad pod «Nemojte uzimati {Zaštićeno ime}»).
English: Metoclopramide can be used during pregnancy if clinically needed.
Croatian: Metoklopramid se može primjenjivati u trudnoći ako je to klinički potrebno.
English: * Endocrine disorders during prolonged treatment in relation with hyperprolactinaemia (amenorrhoea, galactorrhoea, gynaecomastia).
Croatian: * Endokrini poremećaji tijekom duljeg liječenja, povezani s hiperprolaktinemijom (amenoreja, galaktoreja, ginekomastija).
English: [Appropriate measuring device must be provided with the product, and instructions for use must be included in the SmPC]
Croatian: [Uz lijek je potrebno osigurati i odgovarajući odmjerni uređaj, a upute za uporabu moraju biti uključene u Sažetak opisa svojstava lijeka]
English: The solution can be administered intravenously or intramuscularly.
Croatian: Otopina se može primijeniti intravenski ili intramuskularno.
English: Combination to be avoided Alcohol potentiates the sedative effect of metoclopramide.
Croatian: Kombinacija koju je potrebno izbjegavati Alkohol pojačava sedativni učinak metoklopramida.
English: {Tradename} with alcohol For all routes of administration
Croatian: {Zaštićeno ime} s alkoholom Za sve puteve primjene
English: Children and adolescents Metoclopramide must not be used in children aged less than 1 year (see section 2).
Croatian: Djeca i adolescenti Metoklopramid se ne smije davati djeci u dobi ispod 1 godine (pogledajte dio 2).
English: The clearance of metoclopramide is reduced by up to 70% in patients with severe renal impairment, while the plasma elimination half-life is increased (approximately 10 hours for a creatinine clearance of 10-50 mL/minute and 15 hours for a creatinine clearance <10 mL/minute).
Croatian: Klirens metoklopramida smanjen je za do 70% u bolesnika s teškim oštećenjem funkcije bubrega, dok je poluvrijeme eliminacije iz plazme povećano (oko 10 sati za klirens kreatinina od 10-50 ml/minuti i 15 sati za klirens kreatinina <10 ml/minuti).
English: Uncommon Amenorrhoea, Hyperprolactinaemia, Rare
Croatian: Manje često Amenoreja, hiperprolaktinemija Rijetko
English: Treatment should not exceed 3 months because of the risk of tardive dyskinesia (see section 4.8).
Croatian: Liječenje ne smije trajati dulje od 3 mjeseca zbog rizika od tardivne diskinezije (vidjeti dio 4.8).
English: How to take {Tradename}
Croatian: Kako uzimati {Zaštićeno ime}
English: In patients with cirrhosis of the liver, accumulation of metoclopramide has been observed, associated with a 50% reduction in plasma clearance.
Croatian: U bolesnika s cirozom jetre, zabilježeno je nakupljanje metoklopramida, povezano sa smanjenjem plazmatskog klirensa od 50%.
English: These reactions occur usually at the beginning of the treatment and can occur after a single administration.
Croatian: Te se reakcije obično javljaju na početku liječenja i mogu se javiti i nakon jedne primjene.
English: Prolonged treatment with metoclopramide may cause tardive dyskinesia, potentially irreversible, especially in the elderly.
Croatian: Produljeno liječenje metoklopramidom može uzrokovati tardivnu diskineziju, potencijalno ireverzibilnu, i to posebno u starijih osoba.
English: In cases of abnormal levels (methaemoglobinemia), the treatment should be immediately and permanently stopped.
Croatian: U slučaju poremećaja njihove razine (methemoglobinemija), liječenje je potrebno odmah i trajno prekinuti.
English: Treatment must be discontinued if clinical signs of tardive dyskinesia appear.
Croatian: Liječenje se mora prekinuti ako se pojave klinički znakovi tardivne diskinezije.
English: Additional statements related to excipients
Croatian: Dodatne izjave koje se odnose na pomoćne tvari
English: This may affect your vision and also interfere with your ability to drive and use machines.
Croatian: To može utjecati na Vaš vid i na sposobnost upravljanja vozilima i rada sa strojevima.
English: - fluoxetine and paroxetine (medicine used to treat depression)
Croatian: fluoksetin i paroksetin (lijek za liječenje depresije).
English: The dose should be reduced if you have severe liver problems.
Croatian: Dozu je potrebno smanjiti ako imate teških problema s jetrom.
English: Metoclopramide should be discontinued immediately in the event of symptoms of neuroleptic malignant syndrome and appropriate treatment should be initiated.
Croatian: Primjenu metoklopramida potrebno je odmah prekinuti u slučaju pojave simptoma neuroleptičkog malignog sindroma te je potrebno započeti odgovarajuće liječenje.
English: These may occur in children or young adults and particularly when high doses are used.
Croatian: Mogu se javiti u djece ili mlađih odraslih i posebno ako se koriste veće doze.
English: Pregnancy, breast-feeding For all routes of administration
Croatian: Trudnoća, dojenje Za sve puteve primjene
English: These signs usually occur at the beginning of treatment and may even occur after one single administration.
Croatian: Ti se znakovi obično javljaju na početku liječenja i mogu se javiti čak i nakon jedne primjene.
English: Metoclopramide exposure levels are increased when co-administered with strong CYP2D6 inhibitors such as fluoxetine and paroxetine.
Croatian: Razine izloženosti metoklopramidu povećane su u slučaju istovremene primjene snažnih inhibitora CYP2D6 kao što su fluoksetin i paroksetin.
English: Warnings and precautions For all routes of administration
Croatian: Upozorenja i mjere opreza Za sve puteve primjene
English: These effects are generally completely reversible after treatment discontinuation, but may require a symptomatic treatment (benzodiazepines in children and/or anticholinergic anti-Parkinsonian medicinal products in adults).
Croatian: Ti su učinci obično potpuno reverzibilni nakon prekida liječenja, ali mogu iziskivati simptomatsko liječenje (benzodiazepini u djece i/ili antikolinergički antiparkinsonici u odraslih).
English: Central nervous system depressants (morphine derivatives, anxiolytics, sedative H1 antihistamines, sedative antidepressants, barbiturates, clonidine and related) Sedative effects of Central Nervous System depressants and metoclopramide are potentiated.
Croatian: Depresori središnjeg živčanog sustava (derivati morfina, anksiolitici, sedativni H1 antihistaminici, sedativni antidepresivi, barbiturati, klonidin i srodni lijekovi) Pojačani su sedativni učinci depresora središnjeg živčanog sustava i metoklopramida.
English: It will be given as a slow injection into a vein (over at least 3 minutes) or by injection into a muscle.
Croatian: Lijek se daje polaganom injekcijom u venu (u trajanju od najmanje 3 minute) ili injekcijom u mišić.
English: Uncommon Bradycardia, particularly with intravenous formulation
Croatian: Manje često Bradikardija, posebno s intravenskom formulacijom
English: In case of extrapyramidal symptoms related or not to overdose, the treatment is only symptomatic (benzodiazepines in children and/or anticholinergic anti-parkinsonian medicinal products in adults).
Croatian: U slučaju pojave ekstrapiramidnih simptoma koji su povezani ili nisu povezani s predoziranjem, liječenje je samo simptomatsko (benzodiazepini u djece i/ili antikolinergički antiparkinsonici u odraslih).
English: Alcohol should not be consumed during treatment with metoclopramide because it increases the sedative effect of {Tradename}.
Croatian: Alkohol se ne smije konzumirati tijekom liječenja metoklopramidom jer pojačava sedativni učinak {Zaštićeno ime}.
English: The use of metoclopramide with serotonergic drugs such as SSRIs may increase the risk of serotonin syndrome.
Croatian: Primjena metoklopramida sa serotonergičkim lijekovima kao što su selektivni inhibitori ponovne pohrane serotonina može povećati rizik od serotoninskog sindroma.
English: For all routes of administration at the exception of prolonged release preparations
Croatian: Za sve puteve primjene, izuzev pripravaka s produljenim oslobađanjem
English: - Drowsiness, decreased level of consciousness, confusion, hallucination.
Croatian: - Omamljenost, smanjena razina svijesti, konfuzija, halucinacije.
English: Therefore metoclopramide is not recommended during breastfeeding.
Croatian: Stoga se ne preporučuje primjena metoklpramida tijekom dojenja.
English: Special care should be taken when administering metoclopramide, particularly via the intravenous route to the elderly population, to patients with cardiac conduction disturbances (including QT prolongation), patients with uncorrected electrolyte imbalance, bradycardia and those taking other drugs known to prolong QT interval.
Croatian: Poseban oprez potreban je tijekom primjene metoklopramida, posebno intravenskim putem u starije populacije, bolesnika s poremećajima srčane provodljivosti (uključujući produljenje QT intervala), bolesnika s nekorigiranom neravnotežom elektrolita, bradikardijom i onih koji uzimaju druge lijekove za koje je poznato da produljuju QT interval.
English: Not known Tardive dyskinesia which may be persistent, during or after prolonged treatment, particularly in elderly patients (see section 4.4), Neuroleptic malignant syndrome (see section 4.4)
Croatian: Nije poznato Tardivna diskinezija koja može biti perzistentna, tijekom ili nakon duljeg liječenja, pogotovo u starijih bolesnika (vidjeti dio 4.4), neuroleptički maligni sindrom (vidjeti dio 4.4)
English: These may be signs of a condition called neuroleptic malignant syndrome changes in heart beat, which may be shown on an ECG test cardiac arrest (particularly with injection route) shock (severe decrease of heart pressure) (particularly with injection route) fainting (particularly with intravenous route) allergic reaction which may be severe (particularly with intravenous route) very high blood pressure.
Croatian: To mogu biti znakovi stanja koje se naziva neuroleptički maligni sindrom promjene otkucaja srca, što se može vidjeti na EKG-u zastoj srca (posebno pri primjeni putem injekcije) šok (jak pad srčanog tlaka) (posebno pri primjeni putem injekcije) nesvjestica (osobito pri primjeni u venu) alergijska reakcija koja može biti teška (osobito pri primjeni u venu) vrlo visok krvni tlak.
English: In patients with end stage renal disease (Creatinine clearance ≤ 15 ml/min), the daily dose should be reduced by 75%.
Croatian: U bolesnika s bolešću bubrega u završnom stadiju (klirens kreatinina ≤ 15 ml/min), dnevnu je dozu potrebno smanjiti za 75%.
English: Cyclosporine
Croatian: Ciklosporin
English: Metoclopramide should be discontinued immediately in the event of extrapyramidal symptoms.
Croatian: Primjenu metoklopramida potrebno je odmah prekinuti u slučaju pojave ekstrapiramidnih simptoma.
English: Metoclopramide may have an additive effect with other neuroleptics on the occurrence of extrapyramidal disorders.
Croatian: Metoklopramid može imati aditivni učinak s drugim neurolepticima na pojavu ekstrapiramidnih poremećaja.
English: Adults with liver problems
Croatian: Odrasli s jetrenim problemima
English: Metoclopramide may cause drowsiness, dizziness, dyskinesia and dystonias which could affect the vision and also interfere with the ability to drive and operate machinery.
Croatian: Metoklopramid može uzrokovati omamljenost, omaglicu, diskineziju i distoniju koje mogu utjecati na vid i na sposobnost upravljanja vozilima i rada sa strojevima.
English: The following reactions, sometimes associated, occur more frequently when high doses are used: - Extrapyramidal symptoms: acute dystonia and dyskinesia, parkinsonian syndrome, akathisia, even following administration of a single dose of the medicinal product, particularly in children and young adults (see section 4.4).
Croatian: Sljedeće reakcije, ponekad povezane, javljaju se češće tijekom primjene velikih doza: - Ekstrapiramidni simptomi: akutna distonija i diskinezija, Parkinsonov sindrom, akatizija, čak i nakon primjene jedne doze lijeka, posebno u djece i mlađih odraslih (vidjeti dio 4.4).
English: Anticholinergics and morphine derivatives may have both a mutual antagonism with metoclopramide on the digestive tract motility.
Croatian: I antikolinergici i derivati morfina mogu imati antagonističko djelovanje s metoklopramidom na motilitet probavnog sustava.
English: Intravenous doses should be administered as a slow bolus (at least over 3 minutes) in order to reduce the risk of adverse effects (e.g. hypotension, akathisia).
Croatian: Intravenske doze potrebno je primjenjivati u polaganoj bolus injekciji (u trajanju od najmanje 3 minute) kako bi se smanjio rizik od nuspojava (primjerice hipotenzije, akatizije).
English: Do not exceed 3-month treatment because of the risk of involuntary muscle spasms.
Croatian: Liječenje ne smije trajati dulje od 3 mjeseca zbog rizika od nevoljnih grčeva mišića.
English: Endocrine disorders*
Croatian: Endokrini poremećaji*
English: Metoclopramide can be used in combination with oral analgesics to improve the absorption of analgesics in acute migraine.
Croatian: Metoklopramid se može koristiti u kombinaciji s oralnim analgeticima za poboljšanje apsorpcije analgetika u bolesnika s akutnom migrenom.
English: The dose should be reduced if you have moderate or severe kidney problems.
Croatian: Dozu je potrebno smanjiti ako imate umjerenih ili teških problema s bubrezima.
English: Extrapyramidal disorders may occur, particularly in children and young adults, and/or when high doses are used.
Croatian: Mogu se javiti ekstrapiramidni poremećaji, posebno u djece i mlađih odraslih, i/ili kad se primjenjuju visoke doze.
English: 30mg strength
Croatian: Doza od 30 mg
English: To prevent delayed nausea and vomiting that may occur after chemotherapy (children aged 1-18 years)
Croatian: Za sprječavanje odgođenog nastanka mučnine i povraćanja koji se mogu javiti nakon kemoterapije (djeca u dobi od 1 do 18 godina)
English: Metoclopramide is contraindicated in children aged less than 1 year (see section 4.3).
Croatian: Pedijatrijska populacija Metoklopramid je kontraindiciran u djece u dobi ispod 1 godine (vidjeti dio 4.3).
English: Galactorrhoea Not known Gynaecomastia
Croatian: Nije poznato Ginekomastija
English: Metoclopramide may decrease digoxin bioavailability.
Croatian: Metoklopramid može smanjiti bioraspoloživost digoksina.
English: Parenteral route/IM-IV
Croatian: Parenteralni put primjene/i.m.-i.v.