FrancophonIA/ELRC3.0 huggingface dataset:
English: Membranes Fractions Of Klebsiella Pneumoniae 15 Units / Ml, Ribosomes Of Haemophilus Influenzae 0.5 Units / Ml, Ribosomes Of Streptococcus Pneumoniae 3 Units / Ml, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units / Ml, Ribosomes From Streptococcus Pyogenes Group A 3 Units / Ml
Croatian: Dijelovi membrane bakterije Klebsiella Pneumoniae 15 jedinica / MI, Ribosomi bakterije Haemophilus Influenzae 0,5 jedinica / MI, Ribosomi bakterije Streptococcus Pneumoniae 3 jedinice / MI, Dijelovi ribosoma bakterije Klebsiella Pneumoniae 3,5 jedinica / MI, Ribosomi bakterije Streptococcus Pyogenes Grupe A 3 jedinice / MI
English: Freeze-Dried (Lyophilised), Standardised Bacterial Lysate 3.5mg Capsule
Croatian: Liofilizirani, Standardizirani bakterijski lizat, kapsula od 3,5 mg
English: 3 inhalers (3 x 30 doses) (multipack)
Croatian: Veličina pakovanja u dišne putove Blister (alu) 3 inhalatora (3 x 30 doza) (višestruko pakiranje)
English: MA (EU) number (Invented) name
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Unutarnje pakovanje
English: educational and social measures.
Croatian: obrazovne i socijalne mjere.
English: • it is used in children and adolescents aged 6-17 years.
Croatian: • primjenjuje se u djece i adolescenata u dobi od 6 do 17 godina.
English: WHAT DEXAMED IS AND WHAT IT IS USED FOR
Croatian: ŠTO JE DEKSAMED I ZA ŠTO SE KORISTI
English: • it is not indicated in all children with ADHD.
Croatian: • nije indiciran u sve djece s ADHD-om.
English: A comprehensive treatment programme typically includes psychological, educational and social measures.
Croatian: Sveobuhvatni program liječenja u pravilu obuhvaća psihološke, obrazovne i socijalne mjere.
English: • it is used only after when another medicine called methylphenidate was not sufficiently effective.
Croatian: • primjenjuje se samo kada drugi lijek, zvan metilfenidat, nije bio dostatno djelotvoran.
English: • It should be used as part of a treatment programme which typically includes psychological,
Croatian: • potrebno ga je primjenjivati kao dio programa liječenja, koji u pravilu obuhvaća psihološke,
English: Diagnosis should be made according to DSM-5 criteria or the guidelines in ICD-10 and should be based on a comprehensive multidisciplinary evaluation of the patient.
Croatian: Dijagnozu je potrebno uspostaviti u skladu s kriterijima priručnika DSM-5 ili smjernicama klasifikacije MKB-10 te ju je potrebno temeljiti na sveobuhvatnoj multidisciplinarnoj procjeni bolesnika.
English: 4.1 Therapeutic indications [The wording of this section should read as follows]
Croatian: 4.1 Terapijske indikacije [Tekst u ovom dijelu treba glasiti kako slijedi]
English: [The following wording should be added at the end of this section]
Croatian: [Sljedeći tekst potrebno je dodati na kraju ovog dijela]
English: Note: These amendments are to be incorporated to the valid Summary of Product Characteristics, labelling and package leaflet which are the final versions achieved during the Coordination group procedure
Croatian: Napomena: ove izmjene potrebno je unijeti u važeći sažetak opisa svojstava lijeka, označavanje i uputu o lijeku koji su konačne verzije postignute tijekom postupka Koordinacijske skupine
English: Dexamfetamine possesses a high potential to cause dependency and has been/is frequently abused.
Croatian: Deksamfetamin ima visoki potencijal uzrokovanja ovisnosti te se često zlorabio/zlorabi.
English: Package leaflet: Information for the patient Dexamed 5 mg tablets
Croatian: Uputa o lijeku: Informacija za bolesnika Deksamed 5 mg tablete deksamfetaminsulfat
English: Treatment should be under the supervision of a specialist in childhood and/or adolescent behavioural disorders.
Croatian: Liječenje treba biti pod nadzorom specijalista za poremećaje u ponašanju djece i/ili adolescenata.
English: Dexamfetamine is not indicated in all children with ADHD and the decision to use dexamfetamine must be based on a very thorough assessment of the severity and chronicity of the child's symptoms in relation to the child's age and potential for abuse, misuse or diversion.
Croatian: Deksamfetamin nije indiciran u sve djece s ADHD-om te se odluka o primjeni deksamfetamina mora temeljiti na vrlo temeljitoj procjeni težine i kroničnosti djetetovih simptoma u odnosu na njegovu dob i moguću zlouporabu, pogrešnu primjenu ili primjenu u nedopuštene svrhe.
English: [The following sentence should be added in its place] The risk is generally greater for short acting stimulants than for corresponding long-acting products (see section 4.1).
Croatian: [Na njegovo mjesto potrebno je umetnuti sljedeću rečenicu] Rizik je općenito veći za kratkodjelujuće stimulanse od onog za odgovarajuće dugodjelujuće lijekove
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V.
English: Dexamed is used to treat attention-deficit/hyperactivity disorder (ADHD).
Croatian: Deksamed se primjenjuje za liječenje poremećaja pozornosti s hiperaktivnošću (engl. attention deficit/hyperactivity disorder, ADHD).
English: [These bullet points should read as follows]
Croatian: [Ove natuknice trebaju glasiti kako slijedi]
English: POSSIBLE SIDE EFFECTS
Croatian: 4. MOGUĆE NUSPOJAVE
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Zlouporaba, pogrešna primjena i primjena u nedopuštene svrhe [Tekst u nastavku potrebno je izbrisati]
English: Dexamfetamine is indicated as part of a comprehensive treatment programme for attentiondeficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years when response to previous methylphenidate treatment is considered clinically inadequate.
Croatian: Deksamfetamin je indiciran kao dio sveobuhvatnog programa liječenja poremećaja pozornosti s hiperaktivnošću (engl. attention deficit/hyperactivity disorder, ADHD) u djece i adolescenata u dobi od 6
English: PACKAGE LEAFLET
Croatian: Prijavljivanje nuspojava
English: Amendments to the summary of product characteristics and package leaflet
Croatian: Izmjene sažetka opisa svojstava lijeka i upute o lijeku
English: Reporting of side effects
Croatian: Prijavljivanje sumnji na nuspojavu
English: [The following wording should be added at the end of this section] Reporting of suspected adverse reactions
Croatian: [Tekst u nastavku potrebno je umetnuti na početku dokumenta] Ovaj je lijek pod dodatnim praćenjem.
English: (Invented) name Strength Pharmaceutical Form
Croatian: (Zaštićeni) naziv lijeka
English: Immediate Packaging
Croatian: Doza Farmaceutski oblik Način primjene Unutarnje pakovanje Veličina pakovanja
English: See also information under the heading “Do not take Imprida”.
Croatian: Vidjeti također informacije pod naslovom „Nemojte uzimati Impridu“.
English: It is recommended to take Imprida with some water.
Croatian: Preporučuje se uzeti Impridu s nešto vode.
English: Imprida with food and drink
Croatian: Imprida s hranom i pićem
English: If you take more Imprida than you should
Croatian: Ako uzmete više Impride nego što ste trebali
English: Not all pack sizes may be available in your country.
Croatian: U Vašoj zemlji ne moraju biti dostupne sve veličine pakovanja.
English: Component of a multipack, not to be sold separately.
Croatian: Sastavni dio višestrukog pakovanja, ne smije se prodavati zasebno.
English: Package leaflet: information for the user
Croatian: Uputa o lijeku: Informacija za korisnika
English: What Imprida contains
Croatian: Što Imprida sadrži
English: What Imprida is and what it is used for
Croatian: Što je Imprida i za što se koristi
English: Date of first authorisation: 17 January 2007 Date of latest renewal: 17 January 2012
Croatian: Datum posljednje obnove odobrenja: 17. siječanj 2012.
English: Imprida is not recommended in early pregnancy (first 3 months), and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Croatian: Imprida se ne preporučuje u ranoj trudnoći (prva 3 mjeseca) te se ne smije uzimati kada ste trudni više od 3 mjeseca, jer može ozbiljno naštetiti Vašem djetetu ako se uzima nakon trećeg mjeseca trudnoće.
English: Imprida and older people (age 65 years or over) Your doctor should exercise caution when increasing your dose.
Croatian: Imprida i starije osobe (starosti od 65 ili više godina) Vaš liječnik treba oprezno postupati kod povećavanja doze.
English: What you need to know before you take Imprida
Croatian: Što morate znati prije nego počnete uzimati Impridu
English: Children and adolescents The use of Imprida in children and adolescents is not recommended (aged below 18 years old).
Croatian: Djeca i adolescenti Primjena Impride u djece i adolescenata se ne preporučuje (ispod 18 godina starosti).
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107c stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: Do not take Imprida if you are allergic to amlodipine or to any other calcium channel blockers.
Croatian: Nemojte uzimati Impridu ako ste alergični na amlodipin ili na bilo koji drugi blokator kalcijevih kanala.
English: Your doctor will normally advise you to stop taking Imprida before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Imprida.
Croatian: Liječnik će Vas u pravilu savjetovati da prekinete uzimati Impridu prije trudnoće ili čim saznate da ste trudni te će Vas savjetovati da uzmete drugi lijek umjesto Impride.
English: Over 1,400 hypertensive patients received Imprida once daily in two placebo-controlled trials.
Croatian: Više od 1400 hipertenzivnih bolesnika primalo je Impridu jednom dnevno u dva placebo kontrolirana klinička ispitivanja.
English: If you have taken too many tablets of Imprida, or if someone else has taken your tablets, consult a doctor immediately.
Croatian: Ako ste uzeli previše tableta Impride, ili ako je netko drugi uzeo Vaše tablete, odmah se posavjetujte s liječnikom.
English: In two long-term follow-up studies the effect of Imprida was maintained for over one year.
Croatian: U dva dugotrajna ispitivanja praćenja, učinak Impride bio je održan tijekom više od jedne godine.
English: The safety and efficacy of Imprida in children aged below 18 years have not been established.
Croatian: Sigurnost i djelotvornost Impride u djece u dobi ispod 18 godina nisu ustanovljene.
English: Age, gender, race or body mass index (≥30 kg/m 2, <30 kg/m 2) did not influence the response to
Croatian: Dob, spol, rasa ili indeks tjelesne mase (≥30 kg/m2, <30 kg/m2) nisu utjecali na odgovor na Impridu.
English: You can take Imprida with or without food.
Croatian: Impridu možete uzimati s hranom ili bez nje.
English: if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).
Croatian: ako imate suženje aortnog zaliska (stenoza aorte) ili kardiogeni šok (stanje u kojem Vaše srce ne može opskrbiti tijelo dovoljnom količinom krvi).
English: If a diurectic is also used, the risk of lithium toxicity may presumably be increased further with Imprida.
Croatian: Ako se diuretik također koristi, rizik od toksičnosti litija vjerojatno se može povećati i više s Impridom.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na posebnu opasnost za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, karcinogenog potencijala, reproduktivne i razvojne toksičnosti.
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Croatian: SREDNJA KUTIJA VIŠESTRUKOG PAKOVANJA (BEZ PLAVOG OKVIRA)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU
English: The usual dose of Imprida is one tablet per day.
Croatian: Uobičajena doza Impride je jedna tableta na dan.
English: Correction of this condition prior to administration of Imprida or close medical supervision at the start of treatment is recommended.
Croatian: Preporučuje se korigiranje ovog stanja prije primjene Impride ili pažljiv liječnički nadzor na početku liječenja.
English: Patients taking Imprida and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
Croatian: Bolesnici koji uzimaju Impridu i upravljaju vozilima ili rade na strojevima trebaju imati na umu da se katkada mogu javiti omaglica ili iscrpljenost.
English: What Imprida is and what it is used for What you need to know before you take Imprida
Croatian: Što se nalazi u ovoj uputi Što je Imprida i za što se koristi Što morate znati prije nego počnete uzimati Impridu
English: Do not use this medicine after the expiry date which is stated on the carton and blister.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru.
English: To date there is no experience of the safe use of Imprida in patients who have had a recent kidney transplantation.
Croatian: Do danas ne postoji iskustvo o sigurnoj primjeni Impride u bolesnika kojima je nedavno transplantiran bubreg.
English: If you stop taking Imprida
Croatian: Ako prestanete uzimati Impridu
English: Other medicines and Imprida
Croatian: Drugi lijekovi i Imprida
English: Other possible side effects of Imprida:
Croatian: Ostale moguće nuspojave Impride:
English: There is no experience of overdose with Imprida.
Croatian: Nema iskustva s predoziranjem Impridom.
English: If you get these symptoms, stop taking Imprida and contact your doctor straight away.
Croatian: Ako dobijete ove simptome, prekinite uzimati Impridu i odmah se javite svom liječniku.
English: OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
Croatian: VANJSKA KUTIJA VIŠESTRUKOG PAKOVANJA (S PLAVIM OKVIROM)
English: Imprida is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Croatian: Imprida se ne preporučuje majkama koje doje, a ako želite dojiti liječnik Vam može odabrati drugo liječenje, posebno ako je Vaše dijete novorođenče ili je prijevremeno rođeno.
English: Novartis Europharm Limited Frimley Business Park Camberley GU16 7SR United Kingdom
Croatian: Novartis Europharm Limited Frimley Business Park Camberley GU16 7SR Velika Britanija
English: Amlodipine should be used with caution together with CYP3A4 inducers.
Croatian: Nužan je oprez prilikom primjene amlodipina zajedno s induktorima CYP3A4.
English: You must tell your doctor if you think you are (or might become) pregnant.
Croatian: Obratite se svom liječniku prije nego uzmete Impridu: ako ste bili bolesni (povraćanje ili proljev).
English: Imprida can be used with or without food.
Croatian: Imprida se može primjenjivati s hranom ili bez nje.
English: Do not take Imprida with grapefruit or grapefruit
Croatian: Ne uzimajte Impridu s grejpom ili sokom od grejpa.
English: The safety of Imprida has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Croatian: Sigurnost Impride je ispitivana u pet kontroliranih kliničkih ispitivanja s 5175 bolesnika, od kojih je 2613 primalo valsartan u kombinaciji s amlodipinom.
English: Do not use any Imprida pack that is damaged or shows signs of tampering.
Croatian: Ne koristiti Impridu ako primijetite da je pakovanje oštećeno ili su vidljivi znakovi otvaranja.
English: All packs are available with standard blisters; the 56, 98 and 280 tablet packs are additionally available with perforated unit dose blisters.
Croatian: Sva pakovanja su dostupna sa standardnim blisterima; pakovanja s 56, 98 i 280 tableta su dodatno dostupna s perforiranim blisterima djeljivim na jedinične doze.
English: Multipack: 280 (4 packs of 70) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets
Croatian: Višestruko pakovanje: 280 (4 pakovanja od 70) filmom obloženih tableta Višestruko pakovanje: 280 (20 pakovanja od 14) filmom obloženih tableta
English: Stopping your treatment with Imprida may cause your disease to get worse.
Croatian: Prestanak liječenja Impridom može dovesti do pogoršanja bolesti od koje bolujete.
English: No information is available regarding the use of Imprida during breast-feeding, therefore Imprida is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Croatian: Budući da nisu dostupne informacije o primjeni Impride tijekom dojenja, stoga se Imprida tijekom dojenja ne preporučuje te se savjetuje alternativno liječenje s bolje utvrđenim sigurnosnim profilom tijekom dojenja, posebno kod dojenja novorođenčeta ili nedonoščeta.
English: Imprida has not been studied in any patient population other than hypertension.
Croatian: Imprida nije ispitivana ni u jednoj drugoj populaciji bolesnika, osim u bolesnika s hipertenzijom.
English: For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Imprida containing the same component doses.
Croatian: Bolesnici koji primaju valsartan i amlodipin u odvojenim tabletama/kapsulama, mogu se radi jednostavnosti prebaciti na Impridu koja sadrži iste doze sastojaka.
English: The rate and extent of absorption of Imprida are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Croatian: Brzina i opseg apsorpcije Impride jednaki su bioraspoloživosti valsartana i amlodipina kada se primjenjuju kao pojedinačne tablete.
English: Clinically significant hypotension due to Imprida overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Croatian: Klinički značajna hipotenzija zbog predoziranja Impridom zahtijeva aktivnu kardiovaskularnu potporu, uključujući često praćenje srčane i respiratorne funkcije, podizanje ekstremiteta, uz praćenje volumena cirkulirajuće tekućine i mokrenja.
English: If you forget to take Imprida
Croatian: Ako ste zaboravili uzeti Impridu
English: Imprida combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Croatian: Imprida kombinira dva antihipertenzivna sastojka s komplementarnim mehanizmima kontrole krvnog tlaka u bolesnika s esencijalnom hipertenzijom: amlodipin pripada skupini kalcijevih antagonista, dok valsartan pripada skupini antagonista angiotenzina II.
English: Pack sizes: 56, 98 or 280 film-coated tablets.
Croatian: Veličina pakovanja: 56, 98 ili 280 filmom obloženih tableta.
English: Imprida is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets.
Croatian: Imprida je dostupna u pakovanjima koja sadrže 7, 14, 28, 30, 56, 90, 98 ili 280 tableta i u višestrukim pakovanjima koji sadrže 4 kutije, od kojih svaka sadrži 70 tableta, ili 20 kutija, od kojih svaka sadrži 14 tableta.
English: CARTON OF UNIT PACK
Croatian: KUTIJA JEDINIČNOG PAKOVANJA
English: If hypotension occurs with Imprida, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Croatian: Ako se uz Impridu pojavi hipotenzija, bolesnika treba poleći na leđa i po potrebi, mu dati intravensku infuziju fiziološke otopine.
English: Posology The recommended dose of Imprida is one tablet per day.
Croatian: Doziranje Preporučena doza Impride je jedna tableta na dan.
English: • Concomitant use of Imprida with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Croatian: • Istodobna primjena Impride s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolešću ili oštećenjem bubrega (GFR <60 ml/min/1,73 m2) (vidjeti dijelove 4.5 i 5.1).
English: Imprida should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients.
Croatian: Imprida se treba primjenjivati s oprezom u liječenju hipertenzije u bolesnika s jednostranom ili obostranom stenozom bubrežne arterije ili stenozom bubrežne arterije kod postojanja samo jednog bubrega budući da se u ovih bolesnika može povisiti urea u krvi i serumski kreatinin.
English: Interactions common to the combination No drug-drug interaction studies have been performed with Imprida and other medicinal products.
Croatian: Interakcije koje su česte kod ove kombinacije Nisu provedena ispitivanja interakcija među lijekovima s Impridom i drugim lijekovima.
English: Additional information on the individual components Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential adverse reactions with Imprida as well, even if not observed in clinical trials or during the post-marketing period.
Croatian: Dodatne informacije o pojedinačnim komponentama Nuspojave koje su ranije prijavljene s jednom od pojedinačnih komponenti (amlodipinom ili valsartanom) mogu biti i moguće nuspojave Impridu, iako nisu uočene u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet.
English: Imprida tablets contain two substances called amlodipine and valsartan.
Croatian: Imprida tablete sadrže dvije djelatne tvari koje se zovu amlodipin i valsartan.
English: * Mostly consistent with cholestasis
Croatian: * uglavnom upućuje na kolestazu
English: * mostly consistent with cholestasis
Croatian: * Uglavnom upućuje na kolestazu
English: The amlodipine component of Imprida inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Croatian: Amlodipinska komponenta Impride inhibira transmembranski ulaz iona kalcija u srčani mišić i glatki mišić krvnih žila.
English: Abrupt withdrawal of Imprida has not been associated with a rapid increase in blood pressure.
Croatian: Nagli prekid primjene Impride nije bio povezan s naglim povišenjem krvnog tlaka.
English: If any of the above applies to you, do not take Imprida and talk to your doctor.
Croatian: Ako se bilo što od navedenog odnosi na Vas, nemojte uzeti Impridu i obavijestite svog liječnika.
English: The concomitant use of CYP3A4 inducers (e.g. rifampicin, Hypericum perforatum) may give a lower plasma concentration of amlodipine.
Croatian: Istodobna primjena induktora CYP3A4 (npr. rifampicin, Hypericum perforatum) mogla bi imati za posljedicu nižu koncentraciju amlodipina u plazmi.
English: If any of these apply to you, tell your doctor before taking Imprida.
Croatian: Ako se bilo što od navedenog odnosi na Vas, obavijestite svog liječnika prije uzimanja Impride.