natgillin/translations-raw huggingface dataset:
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. 
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.
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. 
CHMP je zaključio da je način na koji je osmišljeno i provedeno glavno ispitivanje ne omogućuje Odboru utvrđivanje koristi lijeka.
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. 
Nadalje, nije utvrđena djelotvornost lijeka Lympreva nakon uvodne terapije s aktualnim standardom skrbi (takozvanih "anti-CD20" terapija).
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. 
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.
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. 
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.
Lympreva is a medicine that contains the active substance dasiprotimut-T. 
Lympreva je lijek koji sadrži djelatnu tvar dasiprotimut-T.
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. 
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.
What was Lympreva expected to be used for? 
Za što se Lympreva trebao koristiti?
Refusal of the marketing authorisation for Lympreva (dasiprotimut-T) 
Odbijanje odobrenja za stavljanje u promet lijeka Lympreva (dasiprotimut-T)
Refusal of the marketing authorisation for Lympreva (dasiprotimut-T) EMA/249530/2015 
Odbijanje odobrenja za stavljanje u promet lijeka Lympreva (dasiprotimut-T) EMA/372536/2015
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. 
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.
The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with Lympreva. 
Tvrtka je obavijestila CHMP da nema tekućih kliničkih ispitivanja ili programa milosrdnog davanja lijeka Lympreva.
Lympreva is prepared individually for each patient from a sample of their own lymphoma cells. 
Lympreva se priprema zasebno za svakog bolesnika iz uzorka njihovih vlastitih stanica limfoma.
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. 
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.
It was expected to be used in combination with another medicine called granulocyte macrophage colony-stimulating factor (GM-CSF). 
Očekuje se da će se koristiti u kombinaciji s drugim lijekom naziva faktor stimulacije kolonije granulocita i makrofage.
How is Lympreva expected to work? 
Kako je Lympreva trebao djelovati?
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'. 
Očekivano je da će se Lympreva koristiti za liječenje odraslih osoba s folikularnim ne-Hodgkinovim limfomom, rakom tipa bijelih stanica naziva "B stanice".
Patients were given either Lympreva together with GM-CSF, or haemocyanin with GM-CSF. 
Bolesnici su primili lijek Lympreva zajedno sa GM-CSF ili hemocijanin sa GM-CSF.
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. 
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.
Lympreva was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 August 2006, for the treatment of follicular lymphoma. 
Lympreva je uvršten u skupinu lijekova za rijetke bolesti dana 28. kolovoza 2006. za liječenje folikularnog limfoma.
The company that applied for authorisation is Biovest Europe Ltd. 
Tvrtka Biovest Europe
Copalia HCT with food, drink and alcohol 
Copalia HCT s hranom, pićem i alkoholom
Do not take Copalia HCT if you are more than 3 months pregnant. 
Nemojte uzimati Copalia HCT ako ste trudni više od 3 mjeseca.
Your doctor may also check your kidney function. 
Liječnik može također provjeriti funkciju Vaših bubrega. ako
Date of first authorisation: 04 November 2009 Date of latest renewal: 04 July 2014 
Datum posljednje obnove odobrenja: 04. srpanj 2014.
if you experience skin reactions such as rash after sun exposure. 
ako dobijete kožne reakcije kao što je osip nakon izloženosti suncu.
• ACE inhibitors or aliskiren -(see also information under the headings “Do not take Copalia HCT” and “Warnings and precautions”). 
ACE inhibitori ili aliskiren (vidjeti također informacije pod naslovom „Nemojte uzimati Copalia HCT“ i „Upozorenja i mjere opreza“).
Children and adolescents The use of Copalia HCT in children and adolescents under 18 years of age is not recommended. 
Djeca i adolescenti Primjena Copalia HCT-a u djece i adolescenata mlađih od 18 godina se ne preporučuje.
See also information under the heading “Do not take Copalia HCT”. 
Vidjeti također informacije pod naslovom „Nemojte uzimati Copalia HCT“.
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. 
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.
The usual dose of Copalia HCT is one tablet per day. 
Uobičajena doza Copalia HCT-a je jedna tableta na dan.
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. 
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.
Protect your skin from sun exposure and UV rays while taking Copalia HCT. 
Zaštitite svoju kožu od izlaganja suncu i UV zrakama za vrijeme uzimanja Copalia HCT.
Before switching to Copalia HCT patients should be controlled on stable doses of the monocomponents taken at the same time. 
Prije prelaska na Copalia HCT bolesnici trebaju biti kontrolirani na stabilnim dozama monokomponenti koje se uzimaju u isto vrijeme.
However, it is important to take into account that Copalia HCT may increase the hypotensive effect of other antihypertensive agents. 
No važno je uzeti u obzir da Copalia HCT može povećati hipotenzivni učinak drugih antihipertenzivnih lijekova.
(It is also recommended to avoid Copalia HCT in early pregnancy - see Pregnancy section.) 
(Preporučuje se izbjegavati Copalia HCT u ranoj trudnoćividjeti dio Trudnoća.)
The full blood pressure lowering effect was achieved 2 weeks after being on their maximal dose of Copalia HCT. 
Potpuni učinak na sniženje krvnog tlaka postignut je nakon 2 tjedna primjene najviše doze Copalia HCT-a.
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. 
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.
What Copalia HCT is and what it is used for 
Što je Copalia HCT i za što se koristi
To date there is no experience of the safe use of Copalia HCT in patients who have had a recent kidney transplantation. 
Do danas ne postoji iskustvo o sigurnoj primjeni Copalia HCT-a u bolesnika kojima je nedavno transplantiran bubreg.
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). 
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).
Copalia HCT was studied in a double-blind, active controlled study in hypertensive patients. 
Copalia HCT je ispitivana u dvostruko slijepoj, aktivno kontroliranom ispitivanju u hipertenzivnih bolesnika.
Do not take Copalia HCT with grapefruit or grapefruit juice. 
Ne uzimajte Copalia HCT s grejpom ili sokom od grejpa.
There is no relevant use of Copalia HCT in the paediatric population (patients below age 18 years) for the indication of essential hypertension. 
Nema relevantne primjene Copalia HCT-a u pedijatrijskoj populaciji (bolesnici mlađi od 18 godina) za indikaciju esencijalne hipertenzije.
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 
Što je Copalia HCT i za što se koristi Što morate znati prije nego počnete uzimati Copalia HCT Kako uzimati Copalia HCT
The recommended dose of Copalia HCT is one tablet per day, to be taken preferably in the morning. 
Preporučena doza Copalia HCT-a je jedna tableta na dan koju je najbolje uzimati ujutro.
Patients taking Copalia HCT and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur. 
Bolesnici koji uzimaju Copalia HCT i upravljaju vozilima ili rade na strojevima trebaju imati na umu da se katkada mogu javiti omaglica ili iscrpljenost.
These could be symptoms of an increase of pressure in your eye and can happen within hours to a week of taking Copalia HCT. 
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.
If patients taking Copalia HCT suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired. 
Ako bolesnici koji uzimaju Copalia HCT pate od omaglice, glavobolje, umora ili mučnine, njihova sposobnost reagiranja mogla bi biti narušena.
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”). 
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“).
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). 
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).
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). 
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).
The dose of Copalia HCT should be based on the doses of the individual components of the combination at the time of switching. 
Dozu Copalia HCT-a treba temeljiti na dozama pojedinih komponenata kombinacije u vrijeme prelaska.
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). 
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).
If Copalia HCT is used during breast-feeding, doses should be kept as low as possible. 
Ako se Copalia HCT uzima tijekom dojenja, doze moraju biti najmanje moguće.
Therefore, Copalia HCT is not recommended in this population. 
Stoga se u ovoj populaciji Copalia HCT ne preporučuje.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake ”Rok valjanosti”/EXP.
Due to the hydrochlorothiazide component, Copalia HCT is contraindicated in symptomatic hyperuricaemia. 
Zbog hidroklortiazidne komponente Copalia HCT je kontraindicirana u simptomatskoj hiperuricemiji.
Stopping your treatment with Copalia HCT may cause your disease to get worse. 
Prestanak liječenja Copalia HCT-om može dovesti do pogoršanja bolesti od koje bolujete.
Elderly patients, particularly those taking the maximum dose of Copalia HCT (10 mg/320 mg/25 mg), should have their blood pressure checked regularly. 
Starijim bolesnicima, posebno onima koji uzimaju najvišu dozu Copalia HCT-a (10 mg/320 mg/25 mg), treba redovito kontrolirati krvni tlak.
Since renal clearance of lithium is reduced by thiazides, the risk of lithium toxicity may presumably be increased further with Copalia HCT. 
Budući da je bubrežni klirens litija smanjen s tiazidima, rizik od toksičnosti litija vjerojatno se može povećati s Copalia HCT-om.
What you need to know before you take Copalia HCT 
Što morate znati prije nego počnete uzimati Copalia HCT
If you think you may be allergic, do not take Copalia HCT and talk to your doctor. 
Ako mislite da biste mogli biti alergični, nemojte uzeti Copalia HCT i porazgovarajte sa svojim liječnikom.
Copalia HCT can be taken with or without food. 
Copalia HCT se može uzimati s hranom ili bez nje.
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. 
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.
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. 
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.
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. 
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.
If hypokalaemia develops during hydrochlorothiazide therapy, Copalia HCT should be discontinued until stable correction of the potassium balance. 
Ako se hipokalijemija razvije tijekom terapije hidroklorotiazidom, potrebno je prekinuti uzimanje Copalia HCT-a sve dok se postigne stabilna korekcija ravnoteže kalija.
The rate and extent of absorption of amlodipine, valsartan and hydrochlorothiazide from Copalia HCT are the same as when administered as individual dosage forms. 
Brzina i opseg apsorpcije amlodipina, valsartana i hidroklorotiazida iz Copalia HCT-a jednaki su onima pri primjeni pojedinačnih dozirnih oblika.
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. 
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.
You can take Copalia HCT with or without food. 
Copalia HCT možete uzimati s hranom ili bez nje.
Copalia HCT 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. 
Copalia HCT 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.
The amlodipine component of Copalia HCT inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle. 
Amlodipinska komponenta Copalia HCT-a inhibira transmembranski ulaz iona kalcija u srčani mišić i glatki mišić krvnih žila.
Based on the existing data with the components, the use of Copalia HCT is not recommended during first trimester and contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4). 
Na temelju postojećih podataka o komponentama, primjena Copalia HCT-a ne preporučuje se tijekom prvog tromjesečja, dok je tijekom drugog i trećeg tromjesečja trudnoće kontraindicirana (vidjeti dijelove 4.3 i 4.4).
Copalia HCT combines three 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 and hydrochlorothiazide belongs to the thiazide diuretics class of medicines. 
Copalia HCT kombinira tri antihipertenzivna sastojka s komplementarnim mehanizmima kontrole krvnog tlaka u bolesnika s esencijalnom hipertenzijom: amlodipin pripada skupini kalcijevih antagonista, valsartan pripada skupini antagonista angiotenzina II, a hidroklorotiazid pripada skupini tiazidnih diuretika.
In this active controlled clinical trial, the most common reasons for discontinuation of therapy with Copalia HCT were dizziness and hypotension (0.7%). 
Najčešći razlozi prekida terapije Copalia HCT-om u ovom aktivno kontroliranom kliničkom ispitivanju bili su omaglica i hipotenzija (0,7%).
Furthermore, concomitant use of Copalia HCT and NSAIDs may lead to worsening of renal function and an increase in serum potassium. 
Osim toga, istodobna primjena Copalia HCT-a i NSAIL-a može dovesti do pogoršanja bubrežne funkcije i povećanja kalija u serumu.
In the controlled trial of Copalia HCT, the counteracting effects of valsartan 320 mg and hydrochlorothiazide 25 mg on serum potassium approximately balanced each other in many patients. 
U kontroliranom ispitivanju Copalia HCT-a, suprotni učinci 320 mg valsartana i 25 mg hidroklorotiazida na kalij u serumu su se približno uravnotežili u mnogih bolesnika.
Other medicines and Copalia HCT 
Drugi lijekovi i Copalia HCT
Copalia HCT is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipine, valsartan and hydrochlorothiazide and who may benefit from taking one tablet containing all three substances. 
Copalia HCT se primjenjuje za liječenje povišenog krvnog tlaka u odraslih bolesnika čiji je krvni tlak već kontroliran dok uzimaju amlodipin, valsartan i hidroklorotiazid te kojima uzimanje jedne tablete koja sadrži sve tri djelatne tvari može biti od koristi.
In sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur after initiation of treatment with Copalia HCT. 
U bolesnika sa sniženom razinom natrija i/ili smanjenjem volumena tekućine, poput onih koji primaju visoke doze diuretika, nakon početka liječenja Copalia HCT-om moguća je pojava simptomatske hipotenzije.
When Copalia HCT is used in patients with renal impairment periodic monitoring of serum electrolytes (including potassium), creatinine and uric acid serum levels is recommended. 
Kada se Copalia HCT primjenjuje u bolesnika s oštećenjem bubrega preporučuje se periodičko praćenje serumskih elektrolita (uključujući kalij), razina kreatinina i mokraćne kiseline u serumu.
if you have or have had heart failure or coronary artery disease, particularly if you are prescribed the maximum dose of Copalia HCT (10 mg/320 mg/25 mg). 
ako imate ili ste imali zatajenje srca ili bolest koronarnih arterija, posebno ako je propisano da uzimate najvišu dozu Copalia HCT-a (10 mg/320 mg/25 mg).
If excessive hypotension occurs with Copalia HCT, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. 
Ako se uz Copalia HCT pojavi izrazita hipotenzija, bolesnika treba poleći na leđa i po potrebi, mu dati intravensku infuziju fiziološke otopine.
If you get these symptoms, stop taking Copalia HCT and contact your doctor straight away. 
Ako dobijete ove simptome, prekinite uzimati Copalia HCT i odmah se javite svom liječniku.
The safety profile of Copalia HCT presented below is based on clinical studies performed with Copalia HCT and the known safety profile of the individual components amlodipine, valsartan and hydrochlorothiazide. 
Niže prikazani sigurnosni profil Copalia HCT-a temelji se na kliničkim ispitivanjima Copalia HCT-a i poznatom sigurnosnom profilu pojedinačnih komponenti amlodipina, valsartana i hidroklorotiazida.
In case severe or rapid hyponatraemia develops during Copalia HCT therapy, the treatment should be discontinued until normalisation of natraemia. 
U slučaju razvoja teškog ili brzog oblika hiponatrijemije tijekom terapije Copalia HCT-om, liječenje je potrebno prekinuti do normalizacije natrijemije.