FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles
Croatian: Kutija s 2 x 1 bočicom, 2 x 10 bočica i 2 x 50 bočica
English: Light paraffin oil ......................................................................................................... 224.8 to 244.1 mg For the full list of excipients, see section 6.1.
Croatian: Lako parafinsko ulje ............................................................................................224,8 do 244,1 mg
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja)
English: Abortion and premature parturition can occur as a result of CHV infection in bitches, the protection of the bitch against infection has not been studied for this vaccine.
Croatian: Zaštita kuje od infekcije nije proučavana za ovo cjepivo.
English: Eurican Herpes 205 powder and solvent for emulsion for injection.
Croatian: Eurican Herpes 205 prašak i otapalo za emulziju za injekciju.
English: PACKAGE LEAFLET FOR: Eurican Herpes 205 powder and solvent for emulsion for injection
Croatian: UPUTA O VMP ZA : Eurican Herpes 205 prašak i otapalo za emulziju za injekciju
English: Eurican Herpes 205 powder and solvent for emulsion for injection
Croatian: Eurican Herpes 205 prašak i otapalo za emulziju za injekciju
English: The bottles are closed with a butyl elastomer closure and sealed with an aluminium cap Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles.
Croatian: Bočice su zatvorene čepom od butil elastomera i aluminijskom kapicom.
English: Powder and solvent for emulsion for injection Lyophilisate : white pellet.
Croatian: Liofilizat: bijela peleta.
English: Packaging Content Package size
Croatian: Pakovanje Sadržaj
English: Further information can be found here:
Croatian: Dodatne informacije možete pronaći ovdje:
English: It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Croatian: Ova tvrtka može zatražiti ponovno ispitivanje mišljenja u roku od 15 dana od primitka obavijesti o ovom negativnom mišljenju.
English: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: ema.europa.eu/Find medicine/Human medicines/Rare disease designations
English: The company provided data in experimental models from the scientific literature.
Croatian: Tvrtka je dostavila podatke iz eksperimentalnih modela koji su dostupni iz znanstvene literature.
English: The main measure of effectiveness was based on how long the patients lived without their cancer symptoms reappearing or until death.
Croatian: Glavna mjera djelotvornosti temeljila se na tome koliko su dugo bolesnici preživjeli bez ponovnog pojavljivanja simptoma raka ili do smrti.
English: EMA/249530/2015 EMEA/H/C/002772
Croatian: 24. travnja 2015. EMA/372536/2015 EMEA/H/C/002772
English: What is Lympreva?
Croatian: Što je Lympreva?
English: The CHMP also had some concerns regarding some aspects of the manufacture and quality control of the medicine.
Croatian: CHMP bio je također u određenoj mjeri zabrinut zbog pojedinih aspekata proizvodnog postupka i kontrole kvalitete lijeka.
English: It was to be available as a suspension for injection under the skin.
Croatian: Trebao je biti dostupan kao supenzija za potkožnu injekciju.
English: The company also presented the results of one main study involving a total of 177 adults with follicular lymphoma who had responded to induction treatment with an established therapy known as PACE (prednisone, doxyrubicin, cyclophosphamide, and etoposide) and who had no sign of their disease.
Croatian: Tvrtka je također dostavila rezultate jednog glavnog ispitivanja koje je obuhvatilo ukupno 177 odraslih osoba s folikularnim limfomom koji je odgovorio na uvodnu terapiju s utvrđenom terapijom poznatom kao PACE (prednizon, doksirubicin, ciklofosfamid i etopozid) te koji nisu imali znakove svoje bolesti.
English: The CHMP considered that the way the main study was designed and carried out was inadequate to allow the Committee to establish the medicine's benefit.
Croatian: CHMP je zaključio da je način na koji je osmišljeno i provedeno glavno ispitivanje ne omogućuje Odboru utvrđivanje koristi lijeka.
English: In addition, the effectiveness of Lympreva following induction treatment with the current standard of care (the so-called ‘anti-CD20' therapies) has not been demonstrated.
Croatian: Nadalje, nije utvrđena djelotvornost lijeka Lympreva nakon uvodne terapije s aktualnim standardom skrbi (takozvanih "anti-CD20" terapija).
English: On 23 April 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Lympreva, intended for the treatment of patients with follicular non-Hodgkin's lymphoma.
Croatian: Dana 23. travnja 2015., Odbor za lijekove za humanu uporabu (CHMP) usvojio je negativno mišljenje, preporučujući odbijanje odobrenja za stavljanje lijeka u promet za lijek Lympreva, koji je namijenjen liječenju bolesnika s folikularnim ne-Hodgkinovim limfomom.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Lympreva did not outweigh its risks and recommended that it be refused marketing authorisation.
Croatian: Stoga, u tom trenutku CHMP bio je mišljenja da koristi lijeka Lympreva ne nadmašuju njegove rizike, te je preporučio da se odbije izdavanje odobrenja za stavljanje lijeka u promet.
English: Lympreva is a medicine that contains the active substance dasiprotimut-T.
Croatian: Lympreva je lijek koji sadrži djelatnu tvar dasiprotimut-T.
English: Lympreva was expected to be given to patients whose signs of disease had disappeared following an ‘induction' treatment, to maintain the complete disappearance of symptoms of cancer.
Croatian: Očekivano je da će se Lympreva primjenjivati u bolesnika čiji su znakovi bolesti nestali nakon "uvodnog" liječenja kako bi se zadržao potpuni nestanak simptoma raka.
English: What was Lympreva expected to be used for?
Croatian: Za što se Lympreva trebao koristiti?
English: Refusal of the marketing authorisation for Lympreva (dasiprotimut-T)
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Lympreva (dasiprotimut-T)
English: Refusal of the marketing authorisation for Lympreva (dasiprotimut-T) EMA/249530/2015
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Lympreva (dasiprotimut-T) EMA/372536/2015
English: Lympreva is a type of ‘cancer immunotherapy' medicine, a medicine designed to stimulate the patient's immune system (the body's natural defences) so that it attacks and kills the cancer cells.
Croatian: Lympreva je tip "antitumorskog imunoterapijskog" lijeka, lijeka koji je razvijen za stimulaciju imunosnog sustava (prirodne obrane tijela) bolesnika tako da napada i ubija stanice raka.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with Lympreva.
Croatian: Tvrtka je obavijestila CHMP da nema tekućih kliničkih ispitivanja ili programa milosrdnog davanja lijeka Lympreva.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 April 2015
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
English: Lympreva is prepared individually for each patient from a sample of their own lymphoma cells.
Croatian: Lympreva se priprema zasebno za svakog bolesnika iz uzorka njihovih vlastitih stanica limfoma.
English: When injected into the patient's body, these lymphoma-specific proteins are expected to stimulate certain components of the immune system to attack and kill the lymphoma cells.
Croatian: Ako se ubrizgaju u tijelo bolesnika, očekuje se da će ovi proteini specifični za limfom stimulirati određene komponente imunosnog sustava koje napadaju i ubijaju stanice limfoma.
English: It was expected to be used in combination with another medicine called granulocyte macrophage colony-stimulating factor (GM-CSF).
Croatian: Očekuje se da će se koristiti u kombinaciji s drugim lijekom naziva faktor stimulacije kolonije granulocita i makrofage.
English: How is Lympreva expected to work?
Croatian: Kako je Lympreva trebao djelovati?
English: Lympreva was expected to be used to treat adults with follicular non-Hodgkin's lymphoma, a cancer of a type of white blood cells called ‘B cells'.
Croatian: Očekivano je da će se Lympreva koristiti za liječenje odraslih osoba s folikularnim ne-Hodgkinovim limfomom, rakom tipa bijelih stanica naziva "B stanice".
English: Patients were given either Lympreva together with GM-CSF, or haemocyanin with GM-CSF.
Croatian: Bolesnici su primili lijek Lympreva zajedno sa GM-CSF ili hemocijanin sa GM-CSF.
English: The medicine is made up of a protein found in the patient's lymphoma cells, attached to a molecule called haemocyanin, which helps to activate the immune system against the lymphoma cells.
Croatian: Lijek se priprema iz proteina koji se nalazi u stanicama limfoma bolesnika, veže se na molekule naziva hemocijanin, što pomaže da se aktivira imunosni sustav protiv stanica limfoma.
English: Lympreva was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 August 2006, for the treatment of follicular lymphoma.
Croatian: Lympreva je uvršten u skupinu lijekova za rijetke bolesti dana 28. kolovoza 2006. za liječenje folikularnog limfoma.
English: The company that applied for authorisation is Biovest Europe Ltd.
Croatian: Tvrtka Biovest Europe
English: Copalia HCT with food, drink and alcohol
Croatian: Copalia HCT s hranom, pićem i alkoholom
English: Do not take Copalia HCT if you are more than 3 months pregnant.
Croatian: Nemojte uzimati Copalia HCT ako ste trudni više od 3 mjeseca.
English: Your doctor may also check your kidney function.
Croatian: Liječnik može također provjeriti funkciju Vaših bubrega. ako
English: Date of first authorisation: 04 November 2009 Date of latest renewal: 04 July 2014
Croatian: Datum posljednje obnove odobrenja: 04. srpanj 2014.
English: if you experience skin reactions such as rash after sun exposure.
Croatian: ako dobijete kožne reakcije kao što je osip nakon izloženosti suncu.
English: • ACE inhibitors or aliskiren -(see also information under the headings “Do not take Copalia HCT” and “Warnings and precautions”).
Croatian: ACE inhibitori ili aliskiren (vidjeti također informacije pod naslovom „Nemojte uzimati Copalia HCT“ i „Upozorenja i mjere opreza“).
English: Children and adolescents The use of Copalia HCT in children and adolescents under 18 years of age is not recommended.
Croatian: Djeca i adolescenti Primjena Copalia HCT-a u djece i adolescenata mlađih od 18 godina se ne preporučuje.
English: See also information under the heading “Do not take Copalia HCT”.
Croatian: Vidjeti također informacije pod naslovom „Nemojte uzimati Copalia HCT“.
English: Copalia HCT is not recommended in early pregnancy 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: Copalia HCT se ne preporučuje u ranoj trudnoći 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: The usual dose of Copalia HCT is one tablet per day.
Croatian: Uobičajena doza Copalia HCT-a je jedna tableta na dan.
English: Your doctor will normally advise you to stop taking Copalia HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Copalia HCT.
Croatian: Liječnik će Vas u pravilu savjetovati da prekinete uzimati Copalia HCT prije trudnoće ili čim saznate da ste trudni te će Vas savjetovati da uzmete drugi lijek umjesto Copalia HCT-a.
English: Protect your skin from sun exposure and UV rays while taking Copalia HCT.
Croatian: Zaštitite svoju kožu od izlaganja suncu i UV zrakama za vrijeme uzimanja Copalia HCT.
English: Before switching to Copalia HCT patients should be controlled on stable doses of the monocomponents taken at the same time.
Croatian: Prije prelaska na Copalia HCT bolesnici trebaju biti kontrolirani na stabilnim dozama monokomponenti koje se uzimaju u isto vrijeme.
English: However, it is important to take into account that Copalia HCT may increase the hypotensive effect of other antihypertensive agents.
Croatian: No važno je uzeti u obzir da Copalia HCT može povećati hipotenzivni učinak drugih antihipertenzivnih lijekova.
English: (It is also recommended to avoid Copalia HCT in early pregnancy - see Pregnancy section.)
Croatian: (Preporučuje se izbjegavati Copalia HCT u ranoj trudnoćividjeti dio Trudnoća.)
English: The full blood pressure lowering effect was achieved 2 weeks after being on their maximal dose of Copalia HCT.
Croatian: Potpuni učinak na sniženje krvnog tlaka postignut je nakon 2 tjedna primjene najviše doze Copalia HCT-a.
English: Copalia HCT 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 a newborn, or was born prematurely.
Croatian: Copalia HCT 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: What Copalia HCT is and what it is used for
Croatian: Što je Copalia HCT i za što se koristi
English: To date there is no experience of the safe use of Copalia HCT in patients who have had a recent kidney transplantation.
Croatian: Do danas ne postoji iskustvo o sigurnoj primjeni Copalia HCT-a u bolesnika kojima je nedavno transplantiran bubreg.
English: if you had an allergic reaction to other high blood pressure medicines or diuretics (a type of medicine also known as “water tablets”), especially if you suffer from asthma and allergies if you have been sick (vomiting or diarrhoea).
Croatian: ako ste imali alergijsku reakciju na druge lijekove za snižavanje krvnog tlaka ili diuretike (vrsta lijekova također poznata kao „tablete za mokrenje“), posebno ako patite od astme i alergija. ako ste bili bolesni (povraćanje ili proljev).
English: Copalia HCT was studied in a double-blind, active controlled study in hypertensive patients.
Croatian: Copalia HCT je ispitivana u dvostruko slijepoj, aktivno kontroliranom ispitivanju u hipertenzivnih bolesnika.
English: Do not take Copalia HCT with grapefruit or grapefruit juice.
Croatian: Ne uzimajte Copalia HCT s grejpom ili sokom od grejpa.
English: There is no relevant use of Copalia HCT in the paediatric population (patients below age 18 years) for the indication of essential hypertension.
Croatian: Nema relevantne primjene Copalia HCT-a u pedijatrijskoj populaciji (bolesnici mlađi od 18 godina) za indikaciju esencijalne hipertenzije.
English: What Copalia HCT is and what it is used for What you need to know before you take Copalia HCT How to take Copalia HCT
Croatian: Što je Copalia HCT i za što se koristi Što morate znati prije nego počnete uzimati Copalia HCT Kako uzimati Copalia HCT
English: The recommended dose of Copalia HCT is one tablet per day, to be taken preferably in the morning.
Croatian: Preporučena doza Copalia HCT-a je jedna tableta na dan koju je najbolje uzimati ujutro.
English: Patients taking Copalia HCT and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
Croatian: Bolesnici koji uzimaju Copalia HCT i upravljaju vozilima ili rade na strojevima trebaju imati na umu da se katkada mogu javiti omaglica ili iscrpljenost.
English: These could be symptoms of an increase of pressure in your eye and can happen within hours to a week of taking Copalia HCT.
Croatian: Ti bi mogli biti simptomi povišenog tlaka u Vašem oku, koji se može pojaviti unutar nekoliko sati do tjedan dana nakon uzimanja Copalia HCT-a.
English: If patients taking Copalia HCT suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired.
Croatian: Ako bolesnici koji uzimaju Copalia HCT pate od omaglice, glavobolje, umora ili mučnine, njihova sposobnost reagiranja mogla bi biti narušena.
English: if your doctor has told you that you have a narrowing of the valves in your heart (called “aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “obstructive hypertrophic cardiomyopathy”).
Croatian: Vam je liječnik rekao da imate suženje srčanih zalistaka (zvano „aortalna ili mitralna stenoza“) ili da je debljina vašeg srčanog mišića nenormalno povećana (zvano „opstruktivna hipertrofična kardiomiopatija“).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Copalia HCT in all subsets of the paediatric population in essential hypertension (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Copalia HCT u svim podskupinama pedijatrijske populacije u liječenju esencijalne hipertenzije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Talk to your doctor or pharmacist before taking Copalia HCT if you have a low level of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Copalia HCT ako imate nisku razinu kalija ili magnezija u Vašoj krvi (sa ili bez simptoma kao što su slabost mišića, spazmi mišića, poremećen srčani ritam).
English: The dose of Copalia HCT should be based on the doses of the individual components of the combination at the time of switching.
Croatian: Dozu Copalia HCT-a treba temeljiti na dozama pojedinih komponenata kombinacije u vrijeme prelaska.
English: Statistically greater proportions of patients achieved blood pressure control (<140/90 mmHg) with Copalia HCT (71%) compared to each of the three dual combination therapies (45-54%) (p<0.0001).
Croatian: Statistički veći udjeli bolesnika postigli su kontrolu krvnog tlaka (<140/90 mmHg) s Copalia HCT-om (71%) u usporedbi s primjenom bilo koje od tri dvojne kombinacijske terapije (45-54%) (p<0,0001).
English: If Copalia HCT is used during breast-feeding, doses should be kept as low as possible.
Croatian: Ako se Copalia HCT uzima tijekom dojenja, doze moraju biti najmanje moguće.
English: Therefore, Copalia HCT is not recommended in this population.
Croatian: Stoga se u ovoj populaciji Copalia HCT ne preporučuje.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake ”Rok valjanosti”/EXP.
English: Due to the hydrochlorothiazide component, Copalia HCT is contraindicated in symptomatic hyperuricaemia.
Croatian: Zbog hidroklortiazidne komponente Copalia HCT je kontraindicirana u simptomatskoj hiperuricemiji.
English: Stopping your treatment with Copalia HCT may cause your disease to get worse.
Croatian: Prestanak liječenja Copalia HCT-om može dovesti do pogoršanja bolesti od koje bolujete.
English: Elderly patients, particularly those taking the maximum dose of Copalia HCT (10 mg/320 mg/25 mg), should have their blood pressure checked regularly.
Croatian: Starijim bolesnicima, posebno onima koji uzimaju najvišu dozu Copalia HCT-a (10 mg/320 mg/25 mg), treba redovito kontrolirati krvni tlak.
English: Since renal clearance of lithium is reduced by thiazides, the risk of lithium toxicity may presumably be increased further with Copalia HCT.
Croatian: Budući da je bubrežni klirens litija smanjen s tiazidima, rizik od toksičnosti litija vjerojatno se može povećati s Copalia HCT-om.
English: What you need to know before you take Copalia HCT
Croatian: Što morate znati prije nego počnete uzimati Copalia HCT
English: If you think you may be allergic, do not take Copalia HCT and talk to your doctor.
Croatian: Ako mislite da biste mogli biti alergični, nemojte uzeti Copalia HCT i porazgovarajte sa svojim liječnikom.
English: Copalia HCT can be taken with or without food.
Croatian: Copalia HCT se može uzimati s hranom ili bez nje.
English: Copalia HCT is available in packs containing 14, 28, 30, 56, 90, 98 or 280 film-coated tablets, in multipacks of 280 tablets (comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets), and in hospital packs containing 56, 98 or 280 tablets in single perforated dose blisters.
Croatian: Copalia HCT je dostupna u pakiranjima koja sadrže 14, 28, 30, 56, 90, 98 ili 280 filmom obloženih tableta, u višestrukim pakiranjima od 280 tableta (koja sadrže 4 kutije, od kojih svaka sadrži 70 tableta, ili 20 kutija, od kojih svaka sadrži 14 tableta), i u bolničkim pakiranjima koja sadrže 56, 98 ili 280 tableta u perforiranim blisterima djeljivim na jedinične doze.
English: Copalia HCT can be used by people aged 65 years and over at the same dose as for other adults and in the same way as they have already taken the three substances called amlodipine, valsartan and hydrochlorothiazide.
Croatian: Osobe u dobi od 65 i više godina mogu uzimati Copalia HCT u istoj dozi kao i druge odrasle osobe i na isti način na koji su do sada već uzimale tri djelatne tvari zvane amlodipin, valsartan i hidroklorotiazid.
English: Clinically significant hypotension due to Copalia HCT 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 Copalia HCT-om zahtijeva aktivnu kardiovaskularnu potporu, uključujući često praćenje srčane i respiratorne funkcije, podizanje ekstremiteta, uz praćenje volumena cirkulirajuće tekućine i mokrenja.
English: If hypokalaemia develops during hydrochlorothiazide therapy, Copalia HCT should be discontinued until stable correction of the potassium balance.
Croatian: Ako se hipokalijemija razvije tijekom terapije hidroklorotiazidom, potrebno je prekinuti uzimanje Copalia HCT-a sve dok se postigne stabilna korekcija ravnoteže kalija.
English: The rate and extent of absorption of amlodipine, valsartan and hydrochlorothiazide from Copalia HCT are the same as when administered as individual dosage forms.
Croatian: Brzina i opseg apsorpcije amlodipina, valsartana i hidroklorotiazida iz Copalia HCT-a jednaki su onima pri primjeni pojedinačnih dozirnih oblika.
English: In a variety of preclinical safety studies conducted in several animal species with amlodipine, valsartan, hydrochlorothiazide, valsartan/hydrochlorothiazide, amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide (Copalia HCT), there was no evidence of systemic or target organ toxicity that would adversely affect the development of Copalia HCT for clinical use in humans.
Croatian: U nizu nekliničkih ispitivanja sigurnosti, provedenih na nekoliko vrsta životinja s amlodipinom, valsartanom, hidroklorotiazidom, valsartanom/hidroklorotiazidom, amlodipinom/valsartanom te amlodipinom/valsartanom/hidroklorotiazidom (Copalia HCT), nije bilo dokaza sistemske toksičnosti ili toksičnosti za pojedini ciljni organ koji bi negativno utjecali na razvoj Copalia HCT-a za kliničku primjenu u ljudi.
English: You can take Copalia HCT with or without food.
Croatian: Copalia HCT možete uzimati s hranom ili bez nje.