FrancophonIA/ELRC3.0 huggingface dataset:
English: Those patients on celecoxib and concomitant lowdose acetylsalicylic acid experienced 4 fold higher rates of complicated ulcers as compared to those on celecoxib alone.
Slovenian: Med bolniki, ki so hkrati dobivali celekoksib in nizke odmerke acetilsalicilne kisline, je bil delež zapletenih ulkusov 4-krat vecji kot pri uporabnikih celekoksiba samega.
English: Compromised renal or hepatic function and especially cardiac dysfunction are more likely in the elderly and therefore medically appropriate supervision should be maintained.
Slovenian: Poslabšanje delovanja ledvic ali jeter, še posebej pa moteno delovanje srca so verjetnejši pri starejših bolnikih.
English: Metabolism and nutrition disorders Uncommon: hyperkalaemia
Slovenian: Presnovne in prehranske motnje Obcasni: hiperkaliemija
English: In two of the 12-week studies the percentage of patients with endoscopic gastroduodenal ulceration were not significantly different between placebo and celecoxib 200 mg BID and 400 mg BID.
Slovenian: V dveh od teh 12-tedenskih študij se odstotek bolnikov z endoskopsko ugotovljenim ulkusom na želodcu ali dvanajstniku ni znacilno razlikoval med placebom in celekoksibom 200 mg dvakrat na dan oz. 400 mg dvakrat na dan.
English: Patients with a history of sulphonamide allergy or any drug allergy may be at greater risk of serious skin reactions or hypersensitivity reactions (see 4.3).
Slovenian: Resne kožne reakcije ali preobcutljivostne reakcije lahko bolj ogrožajo bolnike z anamnezo alergije na sulfonamide ali alergije na kakršnakoli zdravila (glejte poglavje 4.3).
English: COX-2 selective inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effects.
Slovenian: Selektivni zaviralci COX-2 ne vplivajo na antitrombocitno delovanje, zato niso nadomestilo za acetilsalicilno kislino v profilaksi kardiovaskularnih trombembolicnih bolezni.
English: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use ofcelecoxib (see 4.8).
Slovenian: Z uporabo celekoksiba so bile povezane resne kožne reakcije, nekatere s smrtnim izidom, med njimi eksfoliacijski dermatitis, Stevens-Johnsonov sindrom in toksicna epidermalna nekroliza (glejte poglavje 4.8).
English: 5.2 Pharmacokinetic properties
Slovenian: 5.2 Farmakokineticne lastnosti
English: In a peri-post natal study in rats, pup toxicity was observed.
Slovenian: V neki raziskavi peri- in postnatalne toksicnosti zdravila pri podganah so opažali toksicne ucinke pri mladicih.
English: No statistically significant inhibition of COX-1 (assessed as ex vivo inhibition of thromboxane B2 [TxB2] formation) was observed in this dose range in healthy volunteers.
Slovenian: V tem obmocju odmerkov pri zdravih prostovoljcih niso ugotovili statisticno znacilnega zavrtja COX-1 (ocenjevanega z zavrtjem tvorbe tromboksana B2 [TxB2] ex vivo).
English: *In a pooled analysis of 20 placebo-controlled studies with duration greater than 2 weeks up to 1 year in patients with OA and RA, the excess rate of myocardial infarction in patients treated with celecoxib 200 or 400 mg daily over placebo was 0.7 events per 1000 patients (Rare) and there was no excess of strokes.
Slovenian: V kumulativni analizi 20 s placebom kontroliranih študij pri bolnikih z OA in RA, ki so trajale vec kot 2 tedna in do 1 leta, je bil presežni delež miokardnega infarkta pri bolnikih, ki so dobivali 200 mg ali 400 mg celekoksiba na dan, v primerjavi s placebom, 0,7 incidenta na 1000 bolnikov (redko).
English: Clinical 5
Slovenian: Klinicni vidik 5
English: The following events have been reported in patients receiving celecoxib in 12 placebo and/or active controlled trials.
Slovenian: Pri bolnikih, ki so celekoksib dobivali v 12 preskušanjih, kontroliranih s placebom in/ali aktivno ucinkovino, so porocali o naslednjih ucinkih.
English: Celecoxib was evaluated for the treatment of the inflammation and pain of OA of the knee and hip in approximately 4200 patients in placebo and active controlled trials of up to 12 weeks duration.
Slovenian: Za zdravljenje vnetja in bolecin pri osteoartritisu kolena in kolka so celekoksib ocenili pri približno 4.200 bolnikih v preskušanjih, kontroliranih s placebom ali aktivno ucinkovino, ki so trajala do 12 tednov.
English: Rare: ischaemic stroke* Very rare: vasculitis.
Slovenian: Obcasni: hipertenzija, poslabšanje hipertenzije Redko: ishemicna kap* Zelo redki: vaskulitis
English: Infections and infestations Common: sinusitis, upper respiratory tract infection Uncommon: urinary tract infection
Slovenian: Infekcijske in parazitske bolezni Pogosti: sinuzitis, okužba zgornjih dihal Obcasni: okužbe secil
English: Pharmacodynamic interactions
Slovenian: Farmakodinamicno medsebojno delovanje
English: Renal and urinary disorders Very rare: acute renal failure, interstitial nephritis
Slovenian: Bolezni secil Zelo redki: akutna odpoved ledvic, intersticijski nefritis
English: Based on conventional studies, genotoxicity or carcinogenicity, no special hazard for humans was observed, beyond those addressed in other sections of the SmPC.
Slovenian: Na podlagi konvencionalnih raziskav toksicnosti, genotoksicnosti ali kancerogenosti veckratnih odmerkov zdravila menijo, da zdravilo ne pomeni posebnega tveganja za ljudi, t.j.
English: Celecoxib is excreted in the milk of lactating rats at concentrations similar to those in plasma.
Slovenian: Študij o izlocanju celekoksiba v materinem mleku pri cloveku ni. Celekoksib se izloca v mleku dojecih podgan v koncentraciji, podobni koncentraciji v plazmi.
English: Caution should be exercised when combining celecoxib with warfarin and other oral anticoagulants (See 4.5).
Slovenian: Uporaba celekoksiba v kombinaciji z varfarinom ali drugimi peroralnimi antikoagulansi zato zahteva previdnost (glejte poglavje
English: Therefore, celecoxib should be used with caution in patients with history of cardiac failure, left ventricular dysfunction or hypertension, and in patients with pre-existing oedema from any other reason, since prostaglandin inhibition may result in deterioration of renal function and fluid retention.
Slovenian: Zato je treba celekoksib previdno uporabljati pri bolnikih z anamnezo srcnega popušcanja, disfunkcijo levega prekata ali hipertenzijo, ter pri bolnikih z edemi zaradi kakšnega drugega vzroka.
English: Clinical trials with celecoxib have shown renal effects similar to those observed with comparator NSAIDs.
Slovenian: Klinicna preskušanja so pokazala, da ima celekoksib na ledvice podobne ucinke kot primerjalni nesteroidni antirevmatiki.
English: In the submitted studies, as with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications compared to use of celecoxib alone was shown for concomitant administration of low-dose acetylsalicylic acid (see 5.1).
Slovenian: Tako kot za druge nesteroidne antirevmatike, so v predloženih študijah tudi za celekoksib ugotovili, da njegovo socasno uporabo z majhnimi odmerki acetilsalicilne kisline spremlja vecje tveganje za ulkuse in druge zaplete na prebavilih kot uporabo celekoksiba samega (glejte poglavje 5.1)
English: There is little experience of celecoxib in renal impairment.
Slovenian: Izkušenj s celekoksibom pri okvari jeter je malo.
English: Thus caution is advised when treating patients with renal impairment.
Slovenian: Pri zdravljenju bolnikov z okvaro ledvic je potrebna previdnost.
English: Serious hypersensitivity reactions (anaphylaxis and angioedema) have been reported in patients receiving celecoxib (see 4.8).
Slovenian: Pri bolnikih, ki so dobivali celekoksib, so bile opisane resne preobcutljivostne reakcije (anafilaksija in angioedem) (glejte poglavje 4.8).
English: Opaque, white with two gold bands marked 7767 and 200 (INVENTED NAME 200 mg).
Slovenian: Motno bele kapsule z zlato crto in oznakama 7767 in 200.
English: Increased number of serious cardiovascular events, mainly myocardial infarction, has been found in a long-term placebo-controlled study in subjects with sporadic adenomatous polyps treated with celecoxib at doses of 200mg BID and 400mg BID compared to placebo (see 5.1).
Slovenian: V primerjavi s placebom, so povecano število nevarnih srcnožilnih dogodkov, v glavnem miokardni infarkt, ugotovili pri dolgotrajni, s placebom nadzirani študiji odkrili, pri osebah s sporadicnimi adenomatoznimi polipi, zdravljenih s celekoksibom, v odmerkih po 200 mg dvakrat dnevno in 400 mg dvakrat na dan (glejte poglavje 5.1).
English: There is no clinical experience of overdose.
Slovenian: Presežka možganskih kapi ni bilo.
English: Area
Slovenian: Podrocje
English: Clinical 2
Slovenian: Klinicni vidik 2
English: Coadministration of NSAIDs and cyclosporin or tacrolimus have been suggested to increase the nephrotoxic effect of cyclosporin and tacrolimus.
Slovenian: Socasna uporaba nesteroidnih antirevmatikov in ciklosporina ali takrolimusa domnevno poveca nefrotoksicni ucinek teh dveh zdravil.
English: Opaque, white with two blue bands marked 7767 and 100 (INVENTED NAME 100 mg).
Slovenian: Motno bele kapsule z modro crto in oznakama 7767 in 100.
English: Compared to subjects with normal hepatic function, patients with mild hepatic impairment had a mean increase in Cmax of 53% and in AUC of 26% of celecoxib.
Slovenian: Pri bolnikih z blago okvaro jeter je bila Cmax celekoksiba v povprecju za 53 % vecja, AUC pa za 26 % vecja kot pri preiskovancih z normalnim delovanjem jeter.
English: Musculoskeletal and connective tissue disorders Uncommon: leg cramps
Slovenian: Bolezni mišicno-skeletnega sistema in vezivnega tkiva Obcasni: krci v nogah
English: Germany
Slovenian: Nemcija
English: 5.1 Pharmacodynamic properties
Slovenian: 5.1 Farmakodinamicne lastnosti
English: Clinical 4
Slovenian: Klinicni vidik 4
English: These effects are expected following inhibition of prostaglandin synthesis.
Slovenian: Pri inhibiciji sinteze prostaglandinov so takšni ucinki pricakovani.
English: No clinical data on exposed pregnancies are available for celecoxib.
Slovenian: Za celekoksib ni na voljo klinicnih podatkov od nosecnic, ki so bile izpostavljene zdravilu.
English: Clinical 3
Slovenian: Klinicni vidik 3
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.
Slovenian: Bolniki morajo biti dovolj hidrirani in po zacetku ali spremljajocem zdravljenju ter obcasno še potem je treba poskrbeti za spremljanje in nadziranje delovanja ledvic.
English: In one of the three studies, the APC (Prevention of Sporadic Colorectal Adenomas with Celecoxib), there was a dose-related increase in cardiovascular events (mainly myocardial infarction, MI) at celecoxib doses of 200 mg BID and 400 mg BID compared to placebo.
Slovenian: V eni od treh študij, APC (Preprecevanje sporadicnih kolorektalnih adenomov s celekoksibom), so pri celekoksibu v odmerkih 200 mg dvakrat na dan in 400 mg dvakrat na dan v primerjavi s placebom, ugotovili z odmerkom povezano povecanje srcnožilnih incidentov (predvsem miokardnega infarkta, MI).
English: Hepatic impairment: Treatment should be initiated at half the recommended dose in patients with established moderate liver impairment with a serum albumin of 25-35 g/l.
Slovenian: Jetrna okvara: Pri bolnikih z ugotovljeno zmerno jetrno okvaro (serumski albumin 25-35 g/l) zacnemo zdravljenje s polovicnim priporocenim odmerkom.
English: No clinically significant differences were found in PK parameters of celecoxib between elderly African-Americans and Caucasians.
Slovenian: Med starejšimi Afroamericani in starejšimi belci niso ugotovili klinicno pomembnih razlik v farmakokineticnih parametrih celekoksiba.
English: Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with celecoxib.
Slovenian: Pri bolnikih, zdravljenih s celekoksibom, so se na zgornjih prebavilih pojavljali zapleti (perforacije, ulkusi in krvavitve), ki so bili v nekaterih primerih usodni.
English: Anticoagulant activity should be monitored particularly in the first few days after initiating or changing the dose of celecoxib in patients receiving warfarin or other anticoagulants since these patients have an increased risk of bleeding complications.
Slovenian: Pri bolnikih, ki jemljejo varfarin ali druge antikoagulanse, je treba nadzirati antikoagulantno aktivnost, še posebej prve dni po zacetku zdravljenja s celekoksibom ali spremembi njegovega odmerka.
English: The dose of individually dose-titrated CYP2D6 substrates may need to be reduced when treatment with celecoxib is initiated or increased if treatment with celecoxib is terminated.
Slovenian: Po uvedbi zdravljenja s celekoksibom utegne biti potrebno zmanjšanje odmerka zdravil, katerih odmerek se titrira individualno, po koncu zdravljenja s celekoksibom pa utegne biti potrebno povecanje odmerka teh zdravil.
English: Common: abdominal pain, diarrhoea, dyspepsia, flatulence Uncommon: constipation, eructation, gastritis, stomatitis, vomiting, aggravation of gastrointestinal inflammation
Slovenian: Pogosti: bolecine v trebuhu, driska, dispepsija, flatulenca Obcasni: zaprtje, spahovanje, gastritis, stomatitis, bruhanje, poslabšanje želodcnocrevesnega vnetja Redki: razjeda na dvanajstniku, želodcu, požiralniku, tankem in debelem crevesju , disfagija, predrtje crevesa, ezofagitis, melena
English: {INVENTED NAME, see Annex I } 200 mg capsule, hard.
Slovenian: 200 mg trde kapsule
English: Hepato-biliary disorders Uncommon: abnormal hepatic function Very rare: hepatitis, jaundice, hepatic failure.
Slovenian: Bolezni jeter, žolcnika in žolcevodov Obcasni: nenormalno delovanje jeter Zelo redki: hepatitis, odpoved jeter, zlatenica
English: Uncommon: urticaria
Slovenian: Pogosti: omotica
English: Bleeding events in association with increases in prothrombin time have been reported, predominantly in the elderly, in patients receiving celecoxib concurrently with warfarin, some of them fatal.
Slovenian: Predvsem pri starejših bolnikih in bolnikih, ki so celekoksib dobivali socasno z varfarinom, so bile opisane krvavitve, povezane s podaljšanjem protrombinskega casa; nekatere teh krvavitev so bile usodne.
English: Renal function should be monitored when celecoxib and any of these drugs are combined.
Slovenian: Med uporabo celekoksiba s katerim od teh zdravil je treba nadzirati delovanje ledvic.
English: Dialysis is unlikely to be an efficient method of drug removal due to high protein binding.
Slovenian: Zaradi velike vezave na beljakovine ni verjetno, da bi bilo zdravilo mogoce ucinkovito odstraniti z dializo.
English: As with other drugs known to inhibit prostaglandin synthesis fluid retention and oedema have been observed in patients taking celecoxib.
Slovenian: Pri bolnikih, ki so jemali celekoksib, so zabeležili zastajanje tekocine in edeme, tako kot pri drugih zdravilih, ki zavirajo sintezo prostaglandinov.
English: Treatment should be initiated at half the recommended dose in patients with moderate liver impairment (with serum albumin 25-35g/L).
Slovenian: Pri bolnikih z zmerno okvaro jeter (albumin v serumu od 25 do 35 g/l) je treba zdravljenje zaceti s polovico priporocenega odmerka.
English: 8 MARKETING AUTHORISATION NUMBER(S) [Item to be completed by the Marketing Authorisation Holder once the Marketing Authorisation has been granted.]
Slovenian: Tocka bo dopolnjena s strani imetnika dovoljenja za promet, po izdaji odlocbe.
English: Celecoxib is an oral, selective, cyclooxygenase-2 (COX-2) inhibitor within the clinical dose range (200-400 mg daily).
Slovenian: Peroralno uporabljeni celekoksib v obmocju klinicnih odmerkov selektivno zavira ciklooksigenazo-2 (COX-2).
English: 6.4 Special precautions for storage Do not store above 30
Slovenian: 6.4 Posebna navodila za shranjevanje
English: Nervous system disorders
Slovenian: Psihiatricne motnje
English: Renal impairment: Experience with celecoxib in patients with mild or moderate renal impairment is limited, therefore such patients should be treated with caution.
Slovenian: Ledvicna okvara: Izkušnje z uporabo celekoksiba pri bolnikih z blago do zmerno ledvicno okvaro so omejene, zato takšne bolnike zdravimo previdno (glejte polgavja 4.3, 4.4 in 5.2).
English: A dose dependent effect on TxB2 formation has been observed after high doses of celecoxib.
Slovenian: Po velikih odmerkih celekoksiba so opažali od odmerka odvisen ucinek na nastajanje TxB2.
English: mg twice daily have been administered to healthy subjects for nine days without clinically significant adverse effects.
Slovenian: Klinicnih izkušenj s prevelikim odmerjanjem ni. Zdravim preiskovancem so devet dni aplicirali posamicne odmerke 1.200 mg in veckratne odmerke do 1.200 mg dvakrat na dan brez klinicno pomembnih neželenih ucinkov.
English: Respiratory, thoracic and mediastinal disorders Common: pharyngitis, rhinitis Uncommon: cough, dyspnoea Very rare: bronchospasm.
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti: faringitis, rinitis
English: In some patients, with insufficient relief from symptoms, an increased dose of 200 mg twice daily may increase efficacy.
Slovenian: Po potrebi lahko bolniki jemljejo tudi odmerek 200 mg dvakrat na dan.
English: Strength Pharmaceutical Form
Slovenian: Pharmaceutical Form
English: Immediate Packaging
Slovenian: Stična ovojnina Pakiranje
English: The European Commission granted a marketing authorisation valid throughout the European Union for Copalia HCT on 4 November 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Copalia HCT, veljavno po vsej Evropski uniji, odobrila dne 4. novembra 2009.
English: This is a summary of the European public assessment report (EPAR) for Copalia HCT.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Copalia HCT.
English: Copalia HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning.
Slovenian: Zdravilo Copalia HCT se jemlje peroralno, in sicer se zaužije ena tableta enkrat na dan ob isti uri, če je le mogoče, zjutraj.
English: The main study showed the benefit of the highest strength of Copalia HCT in lowering the blood pressure.
Slovenian: Glavna študija je pokazala koristnost uporabe največjega odmerka zdravila Copalia HCT pri zniževanju krvnega tlaka.
English: The CHMP therefore decided that Copalia HCT's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Copalia HCT večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: The three active substances in Copalia HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
Slovenian: Tri zdravilne učinkovine v zdravilu Copalia HCT so zdravila proti zvišanemu krvnemu tlaku, ki se že uporabljajo v Evropski uniji (EU).
English: For all doses, Copalia HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken separately.
Slovenian: Pri vseh odmerkih je zdravilo Copalia HCT izpolnilo tudi zahteve, s katerimi je bilo dokazano, da je primerljivo s kombinacijami posameznih zdravilnih učinkovin, vzetih ločeno.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Copalia HCT.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Copalia HCT, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: What benefit has Copalia HCT shown during the studies?
Slovenian: Kakšne koristi je zdravilo Copalia HCT izkazalo med študijami?
English: Copalia HCT is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide.
Slovenian: Zdravilo Copalia HCT se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih, pri katerih je krvni tlak že ustrezno uravnan z uporabo kombinacije amlodipina, valsartana in hidroklorotiazida.
English: The most common side effects with Copalia HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention).
Slovenian: Najpogostejši neželeni učinki zdravila Copalia HCT (opaženi pri 1 do 10 bolnikih od 100) so hipokaliemija (nizka raven kalija v krvi), omotica, glavobol, hipotenzija (nizek krvni tlak), dispepsija (zgaga), polakiurija (neobičajno pogosto uriniranje), utrujenost in edem (zadrževanje tekočine).
English: The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Copalia HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.
Slovenian: Povprečno znižanje krvnega tlaka je bilo okrog 39,7/24,7 mmHg pri bolnikih, ki so prejemali zdravilo Copalia HCT, v primerjavi z 32/19,7 mmHg pri bolnikih, ki so prejemali kombinacije valsartan/hidroklorotiazid, 33,5/21,5 mmHg pri bolnikih, ki so prejemali kombinacije valsartan/amlodipin, in 31,5/19,5 mmHg pri bolnikih, ki so prejemali kombinacije hidroklorotiazid/amlodipin.
English: For the full list of all side effects reported with Copalia HCT, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Copalia HCT, glejte navodilo za uporabo.
English: Copalia HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide.
Slovenian: Copalia HCT je zdravilo, ki vsebuje tri zdravilne učinkovine: amlodipin, valsartan in hidroklorotiazid.
English: Patients received either Copalia HCT or one of the three combinations containing only two of the active substances for eight weeks.
Slovenian: Bolniki so osem tednov prejemali bodisi zdravilo Copalia HCT bodisi eno od treh kombinacij, ki so vsebovale le dve zdravilni učinkovini.
English: In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Copalia HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide).
Slovenian: Poleg tega je bila izvedena glavna študija, v kateri so proučevali 2 271 bolnikov z zmerno do hudo hipertenzijo, ki so prejemali največji odmerek zdravila Copalia HCT (320 mg valsartana, 10 mg amlodipina in 25 mg hidroklorotiazida).
English: The daily dose of Copalia HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Slovenian: Dnevni odmerek učinkovin zdravila Copalia HCT ne sme biti večji od 10 mg amlodipina, 320 mg valsartana in 25 mg hidroklorotiazida.
English: Other information about Copalia HCT
Slovenian: Druge informacije o zdravilu Copalia HCT
English: The dose of Copalia HCT to be used is the same as the doses of three individual active substances that the patient was taking before.
Slovenian: Odmerek učinkovin zdravila Copalia HCT mora biti enak odmerkom treh posameznih zdravilnih učinkovin, ki jih je bolnik prejemal pred tem.
English: Copalia HCT must not be used in people who are hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Copalia HCT.
Slovenian: Zdravila Copalia HCT ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) zdravilne učinkovine zdravila, druge sulfonamide, derivate dihidropiridina ali katero koli drugo sestavino zdravila Copalia HCT.