FrancophonIA/ELRC3.0 huggingface dataset:
English: When the results of the five studies comparing Enviage taken alone with placebo were looked at together, patients aged under 65 years had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Enviage, from an average of 99.4 mmHg at the start of the study.
Slovenian: Ko so primerjali skupaj rezultate petih študij, v katerih so zdravilo Enviage kot samostojno zdravilo primerjali s placebom, se je pri bolnikih, mlajših od 65 let, po osmih tednih jemanja 150 mg zdravila Enviage povprečni diastolični tlak, ki je na začetku znašal 99,4 mmHg, v povprečju znižal za 9,0 mmHg.
English: Why has Enviage been approved?
Slovenian: Zakaj je bilo zdravilo Enviage odobreno?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Enviage are greater than its risks for the treatment of essential hypertension.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Enviage pri zdravljenju esencialne hipertenzije večje od z njim povezanih tveganj.
English: Enviage is a medicine that contains the active substance aliskiren.
Slovenian: Enviage je zdravilo, ki vsebuje zdravilno učinkovino aliskiren.
English: Enviage also reduced blood pressure in patients with diabetes and patients who were overweight.
Slovenian: Zdravilo Enviage je krvni tlak znižalo tudi pri bolnikih s sladkorno boleznijo in bolnikih s prekomerno težo.
English: Enviage should not be used by people who may be hypersensitive (allergic) to aliskiren or any of the other ingredients.
Slovenian: Zdravila Enviage ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) aliskiren ali katero koli drugo sestavino zdravila.
English: This causes vasodilation (widening of the blood vessels), so that the blood pressure drops.
Slovenian: To povzroči vazodilatacijo (razširjenje žil), zaradi česar krvni tlak pade.
English: For the full list of all side effects reported with Enviage, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Enviage, glejte navodilo za uporabo.
English: Enviage must also not be taken with ciclosporin (a medicine that reduces the activity of the immune system), quinidine (used to correct irregular heartbeat) or verapamil (used to treat heart problems).
Slovenian: Zdravilo Enviage se prav tako ne sme jemati s ciklosporinom (zdravilom, ki zmanjšuje dejavnost imunskega sistema), kinidinom (zdravilom za odpravljanje motenj srčnega ritma) ali verapamilom (zdravilom za zdravljenje težav s srcem).
English: Combination studies looked at Enviage used with an angiotensin converting enzyme inhibitor (ramipril), an angiotensin receptor blocker (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a diuretic (hydrochlorothiazide).
Slovenian: V študijah kombinacij zdravil so zdravilo Enviage proučevali v kombinaciji z zaviralcem angiotenzinske konvertaze (ramiprilom), zaviralcem angiotenzinskih receptorjev (valsartanom), zaviralcem receptorjev beta (atenololom), zaviralcem kalcijevih kanalčkov (amlodipinom) in diuretikom (hidroklorotiazidom).
English: How has Enviage been studied?
Slovenian: Kako je bilo zdravilo Enviage raziskano?
English: Enviage, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
Slovenian: Zdravilo Enviage so kot samostojno zdravilo ali v kombinaciji z drugimi zdravili primerjali tudi z drugimi zdravili za zdravljenje hipertenzije.
English: Enviage on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure.
Slovenian: Zdravilo Enviage kot samostojno zdravilo je bilo pri zdravljenju visokega krvnega tlaka učinkovitejše od placeba in enako učinkovito kot zdravljenje s primerljivimi zdravili.
English: Larger falls were seen in patients aged 65 years or over and those taking higher doses of Enviage.
Slovenian: Pri bolnikih, starih 65 let ali več, in tistih, ki so jemali večje odmerke zdravila Enviage, so opazili večja znižanja tlaka.
English: The active substance in Enviage, aliskiren, is a renin inhibitor.
Slovenian: Zdravilna učinkovina zdravila Enviage, aliskiren, spada med zaviralce renina.
English: By blocking the production of angiotensin I, levels of both angiotensin I and angiotensin II fall.
Slovenian: Zdravilna učinkovina z zaviranjem tvorjenja angiotenzina I zniža raven angiotenzina I in angiotenzina II.
English: What is Enviage?
Slovenian: Kaj je zdravilo Enviage?
English: What is Enviage used for?
Slovenian: Za kaj se zdravilo Enviage uporablja?
English: The full EPAR for Enviage can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Enviage je na voljo tukaj.
English: The dose of Enviage may be increased to 300 mg once a day in patients whose blood pressure is not adequately controlled.
Slovenian: Pri bolnikih, katerih krvni tlak ni primerno nadzorovan, se lahko odmerek zdravila Enviage poveča na 300 mg enkrat na dan.
English: It blocks the activity of a human enzyme called renin, which is involved in the production of a substance called angiotensin I in the body.
Slovenian: Zavira dejavnost človeškega encima, imenovanega renin, ki v telesu sodeluje pri tvorjenju spojine, imenovane angiotenzin I. Angiotenzin I se pretvori v hormon angiotenzin II, ki deluje kot močan vazokonstriktor (učinkovina, ki oži žile).
English: How is Enviage used?
Slovenian: Kako se zdravilo Enviage uporablja?
English: In five of the studies, the effects of Enviage taken alone were compared with those of placebo (a dummy treatment).
Slovenian: uporabljenega kot samostojno zdravilo, primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: Further information can be found here:
Slovenian: Dodatne informacije so na voljo:
English: It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Slovenian: Družba lahko v roku 15 dni od prejema uradnega obvestila o negativnem mnenju zahteva ponovno presojo mnenja.
English: The company provided data in experimental models from the scientific literature.
Slovenian: Predlagatelj je predstavil podatke o poskusnih modelih iz znanstvene literature.
English: The CHMP also had some concerns regarding some aspects of the manufacture and quality control of the medicine.
Slovenian: Odbor CHMP je imel tudi nekaj pomislekov glede nekaterih vidikov izdelave in kontrole kakovosti zdravila.
English: EMA/249530/2015 EMEA/H/C/002772
Slovenian: 24. april 2015 EMA/372525/2015 EMEA/H/C/002772
English: The main measure of effectiveness was based on how long the patients lived without their cancer symptoms reappearing or until death.
Slovenian: Glavno merilo učinkovitosti je temeljilo na času do ponovnega pojava simptomov raka ali do smrti.
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.
Slovenian: Predlagatelj je prav tako predložil rezultate ene glavne študije, ki je vključila skupno 177 odraslih s folikularnim limfomom, ki so se odzvali na indukcijsko zdravljenje z uveljavljeno terapijo, imenovano PACE (prednizon, doksirubicin, ciklofosfamid in etopozid), in niso imeli znakov bolezni.
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.
Slovenian: Odbor CHMP je menil, da načrt in izvedba glavne študije nista bila zadostna, da bi lahko določili koristi zdravila.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with Lympreva.
Slovenian: Družba je odbor CHMP obvestila, da trenutno ne potekajo nobena klinična preizkušanja ali programi sočutne uporabe zdravila Lympreva.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 April 2015
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
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.
Slovenian: Posledično je CHMP tedaj menil, da koristi zdravila Lympreva ne odtehtajo z njim povezanih tveganj in priporočil, da se dovoljenje za promet z njim zavrne.
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.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 23. aprila 2015 priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Lympreva, namenjenim zdravljenju bolnikov s folikularnim ne-Hodgkinovim limfomom.
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.
Slovenian: Poleg tega niso pokazali učinkovitosti zdravila Lympreva po indukcijskem zdravljenju s trenutnim standardnim zdravljenjem (tj. terapijami s protitelesi proti CD 20).
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.
Slovenian: Zdravilo Lympreva na bi se uporabljalo pri bolnikih, pri katerih so znaki bolezni po „indukciji“ zdravljenja izginili, za vzdrževanje popolnega izginotja simptomov raka.
English: Refusal of the marketing authorisation for Lympreva (dasiprotimut-T)
Slovenian: Zavrnitev vloge za dovoljenje za promet z zdravilom Lympreva (dasiprotimut-T)
English: Refusal of the marketing authorisation for Lympreva (dasiprotimut-T) EMA/249530/2015
Slovenian: Zavrnitev vloge za dovoljenje za promet z zdravilom Lympreva (dasiprotimut-T) EMA/372525/2015
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.
Slovenian: Zdravilo Lympreva je bilo dne 28. avgusta 2006 določeno kot »zdravilo sirota« (zdravilo, ki se uporablja pri redkih boleznih) za zdravljenje folikularnega limfoma.
English: What is Lympreva?
Slovenian: Kaj je zdravilo Lympreva?
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.
Slovenian: Lympreva je vrsta „imunoterapevtskega“ zdravila proti raku, ki spodbuja bolnikov imunski sistem (naravno obrambo telesa), tako da napada in ubija rakave celice.
English: Patients were given either Lympreva together with GM-CSF, or haemocyanin with GM-CSF.
Slovenian: Bolniki so prejeli kombinacijo zdravila Lympreva in GM-CSF ali hemocianina in GM-CSF.
English: What was Lympreva expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Lympreva uporabljalo?
English: Lympreva is prepared individually for each patient from a sample of their own lymphoma cells.
Slovenian: Zdravilo Lympreva se na podlagi lastnih celic limfoma posebej pripravi za posameznega bolnika.
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.
Slovenian: Zdravilo je sestavljeno iz beljakovine, ki je v bolnikovih celicah limfoma in se veže na molekulo, imenovano hemocianin, kar pomaga aktivirati imunski sistem proti celicam limfoma.
English: How is Lympreva expected to work?
Slovenian: Kako naj bi zdravilo Lympreva delovalo?
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.
Slovenian: Ko se beljakovine, značilne za limfom, injicirajo v bolnikovo telo, naj bi spodbujale nekatere sestavine imunskega sistema, ki napadejo in ubijejo celice limfoma.
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'.
Slovenian: Zdravilo Lympreva naj bi se uporabljalo za zdravljenje odraslih bolnikov s folikularnim ne-Hodgkinovim limfomom, kar je rak vrste belih krvnih celic, imenovanih celice B. Uporabljalo naj bi se v kombinaciji z drugim zdravilom, imenovanim granulocitne-makrofagne kolonije stimulirajoči faktor (GM-CSF).
English: Lympreva is a medicine that contains the active substance dasiprotimut-T.
Slovenian: Lympreva je zdravilo, ki vsebuje zdravilno učinkovino dasiprotimut-T. Na voljo naj bi bilo v obliki suspenzije za injiciranje pod kožo.
English: Date of first authorisation: 04 November 2009 Date of latest renewal: 04 July 2014
Slovenian: Datum prve odobritve: 4. november 2009 Datum zadnjega podaljšanja: 4. julij 2014
English: (It is also recommended to avoid Copalia HCT in early pregnancy - see Pregnancy section.)
Slovenian: (Priporočeno je, da se zdravilu Copalia HCT izogibate tudi v zgodnji nosečnosti - glejte poglavje Nosečnost.)
English: Do not take Copalia HCT if you are more than 3 months pregnant.
Slovenian: Ne jemljite zdravila Copalia HCT če ste noseči več kot 3 mesece.
English: Copalia HCT was studied in a double-blind, active controlled study in hypertensive patients.
Slovenian: Zdravilo Copalia HCT so proučevali v dvojno slepi, aktivno kontrolirani študiji pri bolnikih s hipertenzijo.
English: • ACE inhibitors or aliskiren -(see also information under the headings “Do not take Copalia HCT” and “Warnings and precautions”).
Slovenian: • zaviralcev ACE ali aliskirena (glejte tudi informacije pod naslovoma “Ne jemljite zdravila Copalia HCT” in “Opozorila in previdnostni ukrepi”).
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.
Slovenian: Zdravnik vam bo praviloma svetoval, da prenehate z jemanjem zdravila Copalia HCT še preden zanosite oziroma takoj, ko ugotovite, da ste noseči in vam bo svetoval jemanje drugega zdravila namesto zdravila Copalia HCT.
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.
Slovenian: To sta lahko simptoma povečanega tlaka v očesu in se lahko pojavita v nekaj urah do enega tedna jemanja zdravila Copalia HCT.
English: The usual dose of Copalia HCT is one tablet per day.
Slovenian: Običajni odmerek zdravila Copalia HCT je ena tableta na dan.
English: Patients taking Copalia HCT and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
Slovenian: Bolniki, ki jemljejo zdravilo Copalia HCT in vozijo motorna vozila ali uporabljajo stroje, morajo upoštevati, da se lahko občasno pojavi omotica ali utrujenost.
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).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Copalia HCT za vse podskupine pediatrične populacije z esencialno hipertenzijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: See also information under the heading “Do not take Copalia HCT”.
Slovenian: Glejte tudi informacije pod naslovom “Ne jemljite zdravila Copalia HCT”.
English: The recommended dose of Copalia HCT is one tablet per day, to be taken preferably in the morning.
Slovenian: Priporočeni odmerek zdravila Copalia HCT je ena tableta na dan, ki jo je najbolje vzeti zjutraj.
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.
Slovenian: Jemanje zdravila Copalia HCT v zgodnjem obdobju nosečnosti ni priporočljivo, če pa ste noseči več kot 3 mesece, ga ne smete jemati, ker lahko uporaba po tretjem mesecu nosečnosti povzroči resno škodo vašemu otroku.
English: However, it is important to take into account that Copalia HCT may increase the hypotensive effect of other antihypertensive agents.
Slovenian: Pomembno pa je upoštevati, da zdravilo Copalia HCT lahko okrepi hipotenzivno delovanje drugih antihipertenzivnih zdravil.
English: What Copalia HCT is and what it is used for
Slovenian: Kaj je zdravilo Copalia HCT in za kaj ga uporabljamo
English: Do not take Copalia HCT with grapefruit or grapefruit juice.
Slovenian: Zdravila Copalia HCT ne zaužijte skupaj z grenivko ali z grenivkinim sokom.
English: There is no relevant use of Copalia HCT in the paediatric population (patients below age 18 years) for the indication of essential hypertension.
Slovenian: Zdravilo Copalia HCT ni namenjeno za uporabo pri pediatrični populaciji (pri bolnikih, mlajših od 18 let) za indikacijo esencialne hipertenzije.
English: To date there is no experience of the safe use of Copalia HCT in patients who have had a recent kidney transplantation.
Slovenian: Doslej ni izkušenj glede varnosti uporabe zdravila Copalia HCT pri bolnikih, ki jim je bila nedavno presajena ledvica.
English: If patients taking Copalia HCT suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired.
Slovenian: Če se pri bolnikih, ki jemljejo zdravilo Copalia HCT, pojavlja omotica, glavobol, utrujenost ali navzea, je njihova zmožnost reagiranja lahko zmanjšana.
English: Children and adolescents The use of Copalia HCT in children and adolescents under 18 years of age is not recommended.
Slovenian: Otroci in mladostniki Pri otrocih in mladostnikih, ki so stari manj kot 18 let, uporaba zdravila Copalia HCT ni priporočena.
English: Copalia HCT can be taken with or without food.
Slovenian: Zdravilo Copalia HCT je mogoče jemati s hrano ali brez nje.
English: The dose of Copalia HCT should be based on the doses of the individual components of the combination at the time of switching.
Slovenian: Odmerek zdravila Copalia HCT mora ustrezati odmerkom posameznih učinkovin kombinacije v času prehoda.
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.
Slovenian: Tablete Copalia HCT so na voljo v pakiranjih, ki vsebujejo 14, 28, 30, 56, 90, 98 ali 280 filmsko obloženih tablet, v skupnih pakiranjih z 280 tabletami (vsebujejo 4 škatle, od katerih vsaka vsebuje po 70 tablet ali 20 škatel, od katerih vsaka vsebuje po 14 tablet), in v bolnišničnih pakiranjih, ki vsebujejo 56, 98 ali 280 tablet v perforiranih pretisnih omotih za enkratni odmerek.
English: The amlodipine component of Copalia HCT inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Slovenian: Amlodipin v zdravilu Copalia HCT zavira transmembranski vstop kalcijevih ionov v srčne in žilne gladke mišice.
English: What you need to know before you take Copalia HCT
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Copalia HCT
English: How to store Copalia HCT Contents of the pack and other information
Slovenian: Shranjevanje zdravila Copalia HCT Vsebina pakiranja in dodatne informacije
English: • severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
Slovenian: • hude kožne reakcije, vključno s hudim kožnim izpuščajem, koprivnico, pordelostjo kože po celem telesu, močnim srbenjem, pojavljanjem mehurjev, lupljenjem in otekanjem kože, vnetjem sluznic (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza) in drugimi alergijskimi reakcijami
English: The use of Copalia HCT during breastfeeding is not recommended.
Slovenian: Uporaba zdravila Copalia HCT med dojenjem ni priporočena.
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
Slovenian: Kaj je zdravilo Copalia HCT in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Copalia HCT Kako jemati zdravilo Copalia HCT Možni neželeni učinki
English: 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.
Slovenian: Pri bolnikih s primanjkljajem natrija in/ali hipovolemijo, na primer pri bolnikih, ki prejemajo visoke odmerke diuretikov, se lahko po uvedbi zdravljenja z zdravilom Copalia HCT pojavi simptomatska hipotenzija.
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.
Slovenian: V različnih predkliničnih študijah varnosti zdravila, ki so jih izvajali na več živalskih vrstah z amlodipinom, valsartanom in hidroklorotiazidom ter s kombinacijami valsartan/hidroklorotiazid, amlodipin/valsartan in amlodipin/valsartan/hidroklorotiazid (z zdravilom Copalia HCT), ni bilo znakov za sistemsko toksično delovanje ali toksično delovanje na tarčne organe, ki bi predstavljali razloge proti razvijanju zdravila Copalia HCT za klinično uporabo pri ljudeh.
English: The full blood pressure lowering effect was achieved 2 weeks after being on their maximal dose of Copalia HCT.
Slovenian: Do polnega učinka na zniževanje krvnega tlaka je prišlo po 2 tednih zdravljenja z najvišjimi odmerki zdravila Copalia HCT.
English: 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).
Slovenian: Glede na obstoječe podatke o posameznih sestavinah uporaba zdravila Copalia HCT ni priporočljiva v prvem trimesečju nosečnosti in je kontraindicirana v drugem in tretjem trimesečju nosečnosti (glejte poglavji 4.3 in 4.4).
English: You can take Copalia HCT with or without food.
Slovenian: Zdravilo Copalia HCT lahko vzamete s hrano ali brez nje.
English: In this active controlled clinical trial, the most common reasons for discontinuation of therapy with Copalia HCT were dizziness and hypotension (0.7%).
Slovenian: V tem aktivno kontroliranem kliničnem preskušanju sta bila najbolj pogosta razloga za prekinitev zdravljenja z zdravilom Copalia HCT omotičnost in hipotenzija
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.
Slovenian: Klinično značilna hipotenzija zaradi prevelikega odmerka zdravila Copalia HCT zahteva srčnožilno podporo, vključno s pogostim nadziranjem delovanja srca in dihal, dviganjem udov ter kontrolo krožečega volumna tekočine in izločanja urina.
English: Copalia HCT is contraindicated in patients with hypercalcaemia and should only be used after correction of any pre-existing hypercalcaemia.
Slovenian: Zdravilo Copalia HCT je kontraindicirano pri bolnikih s hiperkalciemijo in ga je mogoče uporabljati šele po korekciji morebitne že prisotne hiperkalciemije.