FrancophonIA/ELRC3.0 huggingface dataset:
English: Fertility, pregnancy and lactation <Product name> should be administrated with special caution for pregnant women during labour particularly as to serum-sodium if administered in combination with oxytocin (see section 4.4, 4.5 and
Croatian: 4.6. Plodnost, trudnoća i dojenje <naziv lijeka> treba primjenjivati s posebnim oprezom u trudnica tijekom poroda, osobito u odnosu na serumski natrij, ako se primjenjuje u kombinaciji s oksitocinom (vidjeti dio 4.4, 4.5 i 4.8).
English: Amoxicillin; amoxicillin, clavulanic acid - Drug reaction with eosinophilia and systemic symptoms (DRESS) (EPITT no
Croatian: Amoksicilin; amoksicilin, klavulanska kiselina - reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS) (EPITT br. 18802)
English: Patients with cerebral oedema are at particular risk of severe, irreversible and life-threatening brain injury.
Croatian: U bolesnika s cerebralnim edemom postoji osobit rizik od nastanka teške, ireverzibilne ozljede mozga opasne po život.
English: Hyponatraemic encephalopathy**
Croatian: Poremećaji živčanog sustava Hiponatrijemička encefalopatija**
English: If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of <product name>, treatment with <product name> must not be restarted in this patient at any time.
Croatian: U slučaju da se zbog primjene <naziv lijeka> u bolesnika pojave teške kožne reakcije kao što su Stevens-Johnsonov sindrom ili toksična epidermalna nekroliza, ni u jednom trenutku ne smije se ponovno započeti liječenje tog bolesnika lijekom <naziv lijeka>.
English: Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients on penicillin therapy.
Croatian: U bolesnika liječenih penicilinom prijavljene su ozbiljne reakcije preosjetljivosti (uključujući anafilaktoidne reakcije i teške kožne nuspojave) koje su u nekim slučajevima imale smrtni ishod.
English: • Drugs potentiating vasopressin action include: Chlorpropamide, NSAIDs, cyclophosphamide
Croatian: • Lijekovi koji potiču djelovanje vazopresina: klorpropamid, nesteroidni protuupalni lijekovi, ciklofosfamid
English: Chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors,
Croatian: klorpropamid, klofibrat, karbamazepin, vinkristin, selektivni inhibitori ponovne pohrane serotonina, 3,4-metilendioksi-N-metamfetamin, ifosfamid, antipsihotici, narkotici
English: The below listed drugs increase the vasopressin effect, leading to reduced renal electrolyte free water excretion and may increase the risk of hospital acquired hyponatraemia following inappropriately balanced treatment with i.v.
Croatian: Lijekovi koji dovode do povećanog učinka vazopresina Lijekovi navedeni u nastavku povećavaju učinak vazopresina, što dovodi do smanjenog bubrežnog izlučivanja vode bez elekrolita i mogu povećati rizik od bolnički stečene hiponatrijemije nakon neodgovarajuće uravnotežene terapije intravenskim tekućinama (vidjeti dijelove 4.2, 4.4 i 4.8).
English: Section Possible side effects
Croatian: Dio Moguće nuspojave:
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported (see section
Croatian: Prijavljene su teške kožne nuspojave (SCAR), uključujući Stevens-Johnsonov sindrom (SJS) i toksičnu epidermalnu nekrolizu (TEN), koje mogu biti opasne po život ili smrtonosne (vidjeti dio 4.4).
English: Posology and method of administration
Croatian: 4.2. Doziranje i način primjene
English: 3.4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics
Croatian: klorpropamid, nesteroidni protuupalni lijekovi, ciklofosfamid
English: Frequency
Croatian: Učestalost
English: The adjustments are based on an existing SmPC for a Ringer Lactate i.v.
Croatian: Sažetak opisa svojstava lijeka za intravenske tekućine bez glukoze Prilagodbe se temelje na postojećem Sažetku opisa svojstava lijeka za intravensku tekućinu Ringerova laktata.
English: Skin and subcutaneous tissue disorders - (frequency not known) - SJS/TEN, erythema multiforme, blistering, skin ex foliation*
Croatian: Poremećaji kože i potkožnog tkiva - (učestalost nepoznata) - Stevens-Johnsonov sindrom/toksična epidermalna nekroliza, multiformni eritem, mjehurići, ljuštenje kože* Napomena ispod tablice: *vidjeti dio „Opis odabranih nuspojava” u nastavku i dio 4.4.
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment.
Croatian: Posebna upozorenja i mjere opreza pri uporabi Prijavljene su teške kožne nuspojave (SCAR), uključujući Stevens-Johnsonov sindrom (SJS) i toksičnu epidermalnu nekrolizu (TEN), povezane s liječenjem epoetinom, koje mogu biti opasne po život ili smrtonosne.
English: Undesirable effects - subsection ‘Description of selected adverse reactions': Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment (see section 4.4).
Croatian: Prijavljene su teške kožne nuspojave (SCAR), uključujući Stevens-Johnsonov sindrom (SJS) i toksičnu epidermalnu nekrolizu (TEN), povezane s liječenjem epoetinom, koje mogu biti opasne po život ili smrtonosne (vidjeti dio 4.4.).
English: Side effects where the frequency is not known
Croatian: Nuspojave s nepoznatom učestalošću
English: • Do not take a double dose.
Croatian: • Nemojte uzeti dvostruku dozu.
English: Limited long-term safety data are available.
Croatian: Dostupni su ograničeni podaci o dugoročnoj sigurnosti.
English: Always follow your doctor's instructions carefully.
Croatian: Uvijek se pažljivo pridržavajte liječnikovih uputa.
English: • Close the bottle.
Croatian: • Zatvorite bocu.
English: Denmark, Finland:
Croatian: Danska, Finska:
English: It may be some time before you feel the full effect of the medicine.
Croatian: Možda će biti potrebno neko vrijeme da počnete osjećati puni učinak lijeka.
English: The efficacy of activated charcoal has not been established.
Croatian: Djelotvornost aktivnog ugljena nije ustanovljena.
English: It is very important you take the correct amount.
Croatian: Vrlo je važno da uzimate točnu količinu lijeka.
English: Do not throw away any medicines via wastewater <or household waste>.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode <ili kućni otpad>.
English: Haldol and alcohol
Croatian: Haldol i alkohol
English: Stopping treatment suddenly may cause effects such as:
Croatian: Nagli prekid liječenja može izazvati učinke poput:
English: • Unexpected production of breast milk
Croatian: • neočekivano stvaranje mlijeka
English: • Swallow the tablets with some water.
Croatian: • Progutajte tablete s malo vode.
English: This should be considered when deciding which pack to prescribe.
Croatian: To je potrebno uzeti u obzir pri odluci koje pakiranje lijeka će se propisati.
English: • You will not be given more than a total of 20 mg each day.
Croatian: • Nećete primiti više od ukupno 20 mg na dan.
English: Your doctor will also tell you whether to take Haldol one or more times a day.
Croatian: Liječnik će Vam također reći trebate li Haldol uzimati jednom ili više puta dnevno.
English: Haldol is also used in adults:
Croatian: Haldol se također koristi u odraslih:
English: Then keep taking your medicine as your doctor has told you.
Croatian: Zatim nastavite uzimati lijek onako kako Vam je rekao liječnik.
English: Switch from mania to depression
Croatian: Prelazak iz manije u depresiju
English: Children below 6 years of age
Croatian: Djeca mlađa od 6 godina
English: Haldol will be given by a doctor or nurse.
Croatian: Haldol će Vam dati liječnik ili medicinska sestra.
English: • Effects on blood cells - low number of all types of blood cells, including severe decreases in white blood cells and low number of ‘platelets' (cells that help blood to clot)
Croatian: • učinci na krvne stanice - nizak broj svih vrsta krvnih stanica, uključujući znatan pad broja bijelih krvnih stanica i nizak broj krvnih pločica (stanica koje pomažu u zgrušavanju krvi)
English: • Gently press the sides of the bottle and count the number of drops you need to take.
Croatian: • Nježno pritisnite bočne strane boce i izbrojite onoliko kapi koliko trebate uzeti.
English: Non-clinical data reveal no special hazards for humans based on conventional studies of repeat dose toxicity and genotoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti ponovljenih doza i genotoksičnosti.
English: Data are not available for children aged less than 3 years.
Croatian: Nisu dostupni podaci za djecu mlađu od 3 godine.
English: • If you forget to take a dose, take your next dose as usual.
Croatian: • Ako zaboravite uzeti dozu lijeka, uzmite sljedeću dozu u uobičajeno vrijeme.
English: The diluted solution must be taken immediately.
Croatian: Razrijeđena otopina mora se odmah popiti.
English: What Haldol is and what it is used for
Croatian: Što je Haldol i za što se koristi
English: These studies included mainly children and adolescents aged between 2 and 17 years.
Croatian: U tim su ispitivanjima uglavnom sudjelovala djeca i adolescenti u dobi od 2 do 17 godina.
English: It is recommended that HALDOL is not used alone in patients in whom depression is predominant.
Croatian: Preporučuje se da se HALDOL ne primjenjuje sam u bolesnika u kojih je depresija predominantna.
English: See ‘Look out for serious side effects' in section 4.
Croatian: Pogledajte odlomak ‘Pripazite na ozbiljne nuspojave' u dijelu 4.
English: Children and adolescents 6 to 17 years of age
Croatian: Djeca i adolescenti u dobi od 6 do 17 godina
English: • All other indications - half the lowest adult dose.
Croatian: • Sve ostale indikacije - polovica najniže doze za odrasle.
English: Elderly people and people with dementia
Croatian: Starije osobe i osobe s demencijom
English: If antipsychotics are withdrawn, recurrence of symptoms related to the underlying condition may not become apparent for several weeks or months.
Croatian: Ako se prekine primjena antipsihotika, povratak simptoma povezanih s podležećom bolešću može postati primjetan tek nakon nekoliko tjedana ili mjeseci.
English: Other medicines and Haldol
Croatian: Drugi lijekovi i Haldol
English: In schizophrenia, the response to antipsychotic treatment may be delayed.
Croatian: Kod shizofrenije, odgovor na liječenje antipsihoticima može biti odgođen.
English: • Close the bottle, then rinse the oral syringe with some water.
Croatian: • Zatvorite bocu, a zatim isperite štrcaljku za usta s malo vode.
English: Haldol can affect the way the following types of medicine work Tell your doctor if you are taking medicines for:
Croatian: Haldol može utjecati na način djelovanja sljedećih lijekova Obavijestite svog liječnika ako uzimate lijekove za:
English: Plasma concentrations measured at various time points and after various durations of treatment, were either undetectable or ranged up to a maximum of 44.3 ng/ml.
Croatian: Plazmatske koncentracije mjerene u različitim vremenskim točkama i nakon različitog trajanja liječenja bile su ili nemjerljive ili su dosezale najviše 44,3 ng/ml.
English: • You may be given extra doses, normally 1 to 4 hours apart.
Croatian: • Možda ćete primati i dodatne doze, obično u razmaku od 1 do 4 sata.
English: • What condition you are being treated for
Croatian: • bolesti zbog koje se liječite
English: • You have a type of dementia called ‘Lewy body dementia'
Croatian: • ako imate jednu vrstu demencije koja se zove ‘demencija s Lewyjevim tjelešcima'
English: If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including HALDOL, must be considered.
Croatian: Ako se pojave znakovi i simptomi tardivne diskinezije, mora se razmotriti prekid primjene svih antipsihotika, uključujući HALDOL.
English: • 1 to 2 mg intramuscularly, at induction or 30 minutes before the end of anaesthesia.
Croatian: • 1 - 2 mg intramuskularno, pri uvođenju u anesteziju ili 30 minuta prije završetka anestezije.
English: It is for intramuscular use, and is given as an injection into a muscle.
Croatian: Namijenjen je za intramuskularnu primjenu, što znači da se daje injekcijom u mišić.
English: • One end of the oral syringe has a plunger.
Croatian: • Jedan kraj štrcaljke za usta ima klip.
English: • You will not be given more than a total of 5 mg each day unless your doctor decides a higher dose is needed.
Croatian: • Nećete primiti više od ukupno 5 mg na dan osim ako Vaš liječnik ne odluči da je potrebna viša doza.
English: Certain medicines may affect the way that Haldol works or may make heart problems more likely
Croatian: Određeni lijekovi mogu utjecati na način na koji Haldol djeluje ili povećati vjerojatnost razvoja srčanih tegoba
English: • To help control movements in Huntington's disease
Croatian: • kao pomoć za kontroliranje kretnji kod Huntingtonove bolesti
English: • Verapamil (for blood pressure or heart problems).
Croatian: • verapamil (za krvni tlak ili srčane tegobe)
English: • Your age
Croatian: • Vašoj dobi
English: Fertility - Haldol may increase your levels of a hormone called ‘prolactin', which may affect fertility in men and women.
Croatian: Plodnost - Haldol može povisiti razine hormona koji se zove ‘prolaktin', što može utjecati na plodnost u muškaraca i žena.
English: • In adults to help control movements in Huntington's disease.
Croatian: • u odraslih kao pomoć za kontroliranje kretnji kod Huntingtonove bolesti
English: You must fit the oral syringe on the bottle the first time you use it, as follows:
Croatian: Kada prvi put koristite štrcaljku za usta, morate je pričvrstiti za bocu na sljedeći način:
English: Using the oral syringe from then on:
Croatian: Uporaba štrcaljke za usta nakon toga:
English: • May be repeated hourly until sufficient symptom control is achieved.
Croatian: • Primjena se može ponavljati svakih sat vremena do postizanja dostatne kontrole simptoma.
English: • Treatment should be started at the lowest possible dose, and the dose should be adjusted in increments at 2- to 4-hour intervals if agitation continues, up to a maximum of 10 mg/day.
Croatian: • Liječenje je potrebno započeti najnižom mogućom dozom i dozu je potrebno zatim postepeno povećavati u intervalima od 2 do 4 sata ako agitacija potraje, do maksimalno 10 mg na dan.
English: There was a trend toward shorter half-lives in children compared to adults.
Croatian: U djece je primijećen trend kraćeg poluvijeka nego u odraslih.
English: Unless your doctor decides otherwise, Haldol will be stopped gradually.
Croatian: Osim ako Vaš liječnik ne odluči drugačije, Haldol će se prestati primjenjivati postupno.
English: It may be mixed with water to facilitate dose administration, but it must not be mixed with any other liquid.
Croatian: Može se pomiješati s vodom kako bi se olakšala primjena lijeka, ali se ne smije miješati ni s jednom drugom tekućinom.
English: Your doctor may want to take an electrocardiogram (ECG) before or during your treatment with Haldol.
Croatian: Vaš će liječnik možda htjeti napraviti elektrokardiogram (EKG) prije ili tijekom liječenja lijekom Haldol.
English: If patients miss a dose, it is recommended that they take the next dose as usual, and do not take a double dose.
Croatian: Ako bolesnik propusti uzeti dozu, preporučuje se da uzme sljedeću dozu u uobičajeno vrijeme; ne smije uzeti dvostruku dozu.
English: Haldol should not be used in children below 6 years of age.
Croatian: Haldol se ne smije koristiti u djece mlađe od 6 godina.
English: Do this by sliding the upper ring down while still holding the lower ring.
Croatian: Učinite to tako da pritisnete gornji prsten prema dolje i dalje držeći štrcaljku za donji prsten.
English: Your dose of haloperidol will depend on:
Croatian: Doza haloperidola ovisit će o:
English: Haldol is also used:
Croatian: Haldol se također koristi:
English: There have been very rare reports of acute withdrawal symptoms (including nausea, vomiting and insomnia) after abrupt withdrawal of high doses of antipsychotics.
Croatian: Vrlo su rijetko prijavljeni akutni simptomi ustezanja (uključujući mučninu, povraćanje i nesanicu) nakon naglog prekida primjene visokih doza antipsihotika.
English: Patients must always be maintained on the minimal effective dose (see section 5.2).
Croatian: Bolesnike se uvijek mora održavati na minimalnoj učinkovitoj dozi (vidjeti dio 5.2).
English: Haldol is used in adults for illnesses affecting the way you think, feel or behave.
Croatian: Haldol se koristi u odraslih za bolesti koje utječu na to na koji način razmišljate, kako se osjećate ili ponašate.
English: • The highest dose adults should take depends on the condition you are being treated for and varies between 5 mg and 20 mg each day.
Croatian: • Najveća doza koju odrasla osoba smije uzeti ovisi o stanju koje liječite i varira između 5 mg i 20 mg na dan.
English: Based on pooled safety data from these clinical studies, the most commonly reported adverse reactions were: extrapyramidal disorder (34%), insomnia (19%), agitation (15%), hyperkinesia (13%), headache (12%), psychotic disorder (9%), depression (8%), weight increased (8%), tremor (8%), hypertonia (7%), orthostatic hypotension (7%), dystonia (6%) and somnolence (5%).
Croatian: Prema objedinjenim podacima o sigurnosti iz tih kliničkih ispitivanja, najčešće prijavljene nuspojave bile su: ekstrapiramidni poremećaj (34%), nesanica (19%), agitacija (15%), hiperkinezija (13%), glavobolja (12%), psihotični poremećaj (9%), depresija (8%), porast tjelesne težine (8%), tremor (8%), hipertonija
English: Steady state is reached within 1 week of treatment initiation.
Croatian: Stanje dinamičke ravnoteže postiže se unutar 1 tjedna nakon uvođenja liječenja.
English: • You can mix Haldol oral solution in some water before you take it, but don't mix it with any other liquids.
Croatian: • Haldol oralnu otopinu možete pomiješati s malo vode prije nego što je uzmete, ali je ne smijete miješati ni s jednom drugom tekućinom.
English: Haldol is used in adults, adolescents and children for illnesses affecting the way you think, feel or behave.
Croatian: Haldol se koristi u odraslih, adolescenata i djece za bolesti koje utječu na to na koji način razmišljate, kako se osjećate ili ponašate.
English: Do not take this medicine if any of the above applies to you.
Croatian: Nemojte uzimati ovaj lijek ako se nešto od navedenoga odnosi na Vas.
English: • Enlarged breasts in men
Croatian: • rast dojki u muškaraca
English: A doctor or nurse will give this medicine to you, so it is unlikely that you will miss a dose or be given too much.
Croatian: Budući da će Vam ovaj lijek dati liječnik ili medicinska sestra, malo je vjerojatno da ćete propustiti dozu ili primiti previše lijeka.
English: • High level of ‘antidiuretic hormone' in the blood (syndrome of inappropriate antidiuretic hormone secretion)
Croatian: • visoka razina ‘antidiuretskog hormona' u krvi (sindrom neodgovarajućeg lučenja antidiuretskog hormona)
English: • You have a low level of potassium in your blood, which has not been treated
Croatian: • ako imate nisku razinu kalija u krvi, koja se ne liječi
English: However, there have been isolated case reports of birth defects following foetal exposure to haloperidol, mostly in combination with other medicinal products.
Croatian: Međutim, prijavljeni su izolirani slučajevi prirođenih mana nakon izlaganja ploda haloperidolu, uglavnom u kombinaciji s drugim lijekovima.
English: Tell your doctor straight away and stop taking both medicines if you get:
Croatian: Odmah obavijestite svog liječnika i prestanite uzimati oba lijeka ako se pojavi:
English: HALDOL solution for injection is not indicated for the treatment of dementia-related behavioural disturbances.
Croatian: HALDOL otopina za injekciju nije indicirana za liječenje poremećaja ponašanja povezanih s demencijom.
English: If you take more Haldol than you were told to or if someone else has taken any Haldol, talk to a doctor or go to the nearest hospital casualty department straight away.
Croatian: Ako uzmete više lijeka Haldol nego što ste trebali ili ako netko drugi uzme lijek Haldol, odmah se obratite liječniku ili otiđite u najbližu hitnu službu.
English: • Difficulty sleeping.
Croatian: • poteškoća sa spavanjem
English: These include mental health problems (such as schizophrenia and bipolar disorder) and behavioural problems.
Croatian: To uključuje psihičke tegobe (kao što su shizofrenija i bipolarni poremećaj) te probleme s ponašanjem.
English: As a precautionary measure, it is preferable to avoid the use of HALDOL during pregnancy.
Croatian: Kao mjera opreza, poželjno je izbjegavati primjenu lijeka HALDOL u trudnoći.
English: Since haloperidol is extensively metabolised in the liver, it is recommended to halve the initial dose.
Croatian: Budući da se haloperidol opsežno metabolizira u jetri, preporučuje se prepoloviti početnu dozu.
English: • 5 to 10 mg orally, repeated after 12 hours if necessary to a maximum of 20 mg/day.
Croatian: • 5 - 10 mg na dan peroralno; po potrebi ponoviti nakon 12 sati, do maksimalno 20 mg na dan.
English: • In adolescents and children aged 10 to 17 years and in adults for movements or sounds you can't control (tics), for example in severe Tourette's syndrome
Croatian: • u adolescenta i djece u dobi od 10 do 17 godina i u odraslih za pokrete ili zvukove koje ne možete kontrolirati (tikove), primjerice kod teškog oblika Touretteova sindroma
English: • The highest dose elderly people should take is 5 mg each day unless your doctor decides a higher dose is needed.
Croatian: • Najveća doza koju starija osoba smije uzeti je 5 mg na dan osim ako Vaš liječnik ne odluči da je potrebna viša doza.
English: Haldol should not be used in children and adolescents below 18 years.
Croatian: Haldol se ne smije koristiti u djece i adolescenata mlađih od 18 godina.
English: If you take more Haldol than you should
Croatian: Ako uzmete više lijeka Haldol nego što ste trebali
English: The average bioavailability of haloperidol after administration of the tablet or oral solution is 60 to 70%.
Croatian: Prosječna bioraspoloživost haloperidola nakon primjene tablete ili oralne otopine iznosi 60 - 70%.
English: In 2 studies in children receiving haloperidol treatment for tics and Tourette's syndrome, a positive response was associated with plasma concentrations of 1 to 4 ng/ml
Croatian: U 2 ispitivanja provedena u djece liječene haloperidolom zbog tikova i Touretteova sindroma, pozitivan odgovor bio je povezan s plazmatskim koncentracijama od 1 do 4 ng/ml.
English: Additionally, the antidopaminergic effect on the chemoreceptor-trigger zone of the area postrema explains the activity against nausea and vomiting.
Croatian: Osim toga, antidopaminergički učinak na kemoreceptorsku okidačku zonu u području area postrema objašnjava djelovanje protiv mučnine i povraćanja.
English: Available safety data in the paediatric population indicate a risk of developing extrapyramidal symptoms, including tardive dyskinesia, and sedation.
Croatian: Dostupni podaci o sigurnosti u pedijatrijskoj populaciji ukazuju na rizik od razvoja ekstrapiramidnih simptoma, uključujući tardivnu diskineziju, i od sedacije.
English: • Inflamed small blood vessels, leading to a skin rash with small red or purple bumps
Croatian: • upala malih krvnih žila, koja može uzrokovati kožni osip praćen malim crvenim ili ljubičastim kvržicama
English: Peak plasma concentrations of haloperidol are attained within 20 to 40 minutes.
Croatian: Vršne plazmatske koncentracije haloperidola postižu se unutar 20 - 40 minuta.
English: Patients with first-episode schizophrenia generally respond to 2 to 4 mg/day, whereas patients with multiple-episode schizophrenia may need doses up to 10 mg /day.
Croatian: Bolesnici s prvom epizodom shizofrenije obično odgovore na dozu od 2 - 4 mg na dan, dok bolesnicima s višestrukim epizodama shizofrenije mogu biti potrebne doze do 10 mg na dan.