FrancophonIA/ELRC3.0 huggingface dataset:
English: Whereas, the CHMP - is of the Opinion that the benefit/risk balance of medicinal products containing celecoxib in the agreed indications remains favourable and the Marketing Authorisations should be maintained according to revised Summaries of Product Characteristics (attached in Annex III of the CHMP Opinion), - concluded that the cardiovascular safety and serious skin reactions should be continuously and carefully monitored and assessed, - recommended to initiate a long term study to investigate the safety of celecoxib relative to non selective NSAIDs.
Latvian: Nemot to vera, ka CHMP - uzskata, ka ieguvuma/riska attieciba celecoxib saturošajam zalem saskanotajas indikacijas saglabajas labveliga un registracijas apliecibam ir japaliek speka atbilstoši parskatitajiem zalu aprakstiem (pievienoti III pielikuma pie CHMP sledziena), - nolema, ka kardiovaskulara nekaitiguma un nopietno adas reakciju jautajums ir nepartraukti un rupigi jamonitore un jaizverte; - iesaka uzsakt ilgtermina petijumus, lai noskaidrotu celecoxib nekaitigumu, kas atbilstu nesteroidam pretiekaisuma zalem (NSAIDs).
English: For all strokes, there was no increased event rate with celecoxib compared with placebo.
Latvian: Celekoksiba grupa salidzinot ar placebo nenoveroja palielinatu jebkadu insultu biežumu.
English: In animals, exposure to celecoxib during early embryonic development resulted in pre-implantation and post-implantation losses.
Latvian: Dzivniekiem ekspozic ija celekoksibam agrina embrionalas attistibas stadija izraisija embrija bojaeju pirms implantacijas un pec implantacijas.
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).
Latvian: Lielaks nopietnu adas reakciju vai hipersensivitates risks ir pacientiem, kuru anamneze ir alergija pret sulfanilamidiem vai jebkuram citam zalem (skatit apakšpunktu 4.3).
English: General disorders and administration site conditions Common: peripheral oedema/ fluid retention
Latvian: Vispareji traucejumi un reakcijas ievadišanas vieta Bieži: perifera tuska/ škidruma retence
English: Celecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Latvian: Celekoksiba lietošana japartrauc tiklidz uz adas paradas pirmie izsitumi, glotadas bojajumi vai jebkadas citas paaugstinatas jutibas pazimes.
English: Celecoxib has been shown to cause malformations in the two animal species studied (See 4.6 and 5.3).
Latvian: Petijumos ar divu sugu dzivniekiem pieradits, ka celekoksibs šiem dzivniekiem izraisa malformacijas (skatit apakšpunktus 4.6 un 5.3).
English: Therefore, patients receiving oral anticoagulants should be closely monitored for their prothrombin time INR, particularly in the first few days when therapy with celecoxib is initiated or the dose of celecoxib is changed (see 4.4).
Latvian: Ši iemesla del pacientiem, kuri lieto peroralos antikoagulantus, bieži japarbauda protrombina laiks INR, seviški pirmas paris dienas pec celekoksiba terapijas sakšanas vai celekoks iba devas mainas (sk. 4.4).
English: 5.3 Preclinical safety data
Latvian: 5.3 Prekliniskie dati par drošibu
English: Very rare: aggravated epilepsy, meningitis aseptic, ageusia, anosmia
Latvian: Loti reti: epilepsijas paasinajums, aseptisks meningits, ageuzija, anosmija
English: 8 MARKETING AUTHORISATION NUMBER(S) [Item to be completed by the Marketing Authorisation Holder once the Marketing Authorisation has been granted.]
Latvian: [Aizpildis registracijas apliecibas ipašnieks, kad tiks pieškirts registracijas numurs.]
English: Since celecoxib is predominantly metabolised by CYP2C9 it should be used at half the recommended dose in patients receiving fluconazole.
Latvian: Ta ka celekoksibu galvenokart metabolize CYP2C9, pacientiem, kuri vienlaikus sanem flukonazolu, to butu jalieto pusi no ieteicamas devas.
English: 5.2 Pharmacokinetic properties
Latvian: 5.2 Farmakokinetiskas ipašibas
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.
Latvian: Zinots par asinošanas epizodem saistiba ar protrombina laika pieaugumu pacientiem, parsvara gados vecakiem cilvekiem, kuri celekoksibu sanemuši lidztekus varfarinam, dažas no tam fatalas.
English: SCIENTIFIC CONCLUSIONS FOR THE AMENDMENT OF THE MARKETING AUTHORISATION
Latvian: ZINATNISKIE SLEDZIENI PAR GROZIJUMIEM REGISTRACIJAS APLIECIBA
English: The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (4.2, 4.3, 4.8 and 5.1).
Latvian: Periodiski arstešanas gaita, ipaši pacientiem ar osteoartritu, ir janoverte nepieciešamiba pacientam mazinat slimibas simptomus, ka ari reakcija uz terapiju (skatit apakšpunktus 4.2, 4.3, 4.8 un 5.1).
English: Marketing Authorisation Holder
Latvian: REGISTRACIJAS APLIECIBAS IPAŠNIEKS
English: Clinical 1
Latvian: 1. kliniskais posms
English: 4.6 Pregnancy and lactation
Latvian: 4.6 Grutnie ciba un zidišana
English: It was also evaluated for treatment of the inflammation and pain of RA in approximately 2100 patients in placebo and active controlled trials of up to 24 weeks duration.
Latvian: Tas tika lietots ari placebo un aktivi kontroleta lidz 24 nedelu ilga petijuma reimatoida artrita iekaisuma un sapju terapija aptuveni 2100 pacientiem.
English: A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs. NSAIDs + acetylsalicylic acid has not been demonstrated in longterm clinical trials (see 5.1).
Latvian: Ilgtermina kliniskos petijumos nav ieguti rezultati, kas apliecinatu butisku atškiribu gastrointestinalas drošibas zina lietojot selektivos COX-2 inhibitorus + acetilsalicilskabi salidzinajuma ar NSPL + acetilsalicilskabe (skatit apakšpunktu 5.1).
English: The CHMP confirmed changes to the Product Information already introduced through a type II variation adopted in May 2005 further to the February USR and requested further changes.
Latvian: CHMP apstiprinaja izmainas zalu informacija, kas jau bija ieviestas ar II.
English: Uncommon: urticaria
Latvian: Loti reti: vaskulits
English: There are no studies on the excretion of celecoxib in human milk.
Latvian: Par celekoksiba ekskreciju mates piena petijumu nav.
English: The pharmacokinetics of celecoxib has not been studied in patients with renal impairment but is unlikely to be markedly changed in these patients.
Latvian: Celekoksiba farmakokinetika pacientiem ar nieru mazspeju nav petita, tacu mazticams, ka šiem pacientiem butu redzamas izmainas.
English: Clinical 2
Latvian: 2. kliniskais posms
English: Hepato-biliary disorders Uncommon: abnormal hepatic function Very rare: hepatitis, jaundice, hepatic failure.
Latvian: Aknu un/vai žultscelu traucejumi Retak: trauceta aknu funkcija Loti reti: hepatits, dzelte, aknu mazspeja
English: If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of celecoxib therapy should be considered.
Latvian: Ja arstešanas laika pacientam novero jebkuras augstak minetas organu sistemas funkcijas pasliktinašanos, tad ir attiecigi jarikojas un jaapsver iespeja partraukt terapiju ar celekoksibu.
English: Psychiatric disorders Common: insomnia
Latvian: Psihiskie traucejumi Bieži: bezmiegs
English: Clinical trials with celecoxib have shown renal effects similar to those observed with comparator NSAIDs.
Latvian: Celekoksiba kliniskie petijumi pieradijuši, ka iedarbiba uz nierem ir vienada ka salidzinošiem NSPIL.
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.
Latvian: Aknu darbibas traucejumi: Pacientiem ar mereni izteiktiem aknu funkciju traucejumiem (albumins seruma 25-35 g/l) arstešana jauzsak ar pusi no ieteicamas devas.
English: If a woman becomes pregnant during treatment, celecoxib should be discontinued.
Latvian: Ja grutnieciba iestajas arstešanas laika, celekoksiba lietošana japartrauc.
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.
Latvian: Viena no šiem tris petijumiem (sporadiskas kolorektalas adenomas profilakse ar celekoksibu), lietojot celekoksibu devas 200 mg divas reizes un 400 mg divas reizes diena salidzinajuma ar placebo, konstateja devas atkarigu kardiovaskularo notikumu (galvenokart miokarda infarkta - MI) pieaugumu.
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.
Latvian: Placebo un aktivi kontroletos lidz 12 nedelu ilgos petijumos celekoksibs tika lietots cela un gužas osteoartrita iekaisuma un sapju gadijuma aptuveni 4200 pacientiem.
English: Cyclooxygenase is responsible for generation of prostaglandins.
Latvian: Ciklooksigenaze ir enzims, kas nepieciešams prostaglandinu sintezes procesa.
English: Serious hypersensitivity reactions (anaphylaxis and angioedema) have been reported in patients receiving celecoxib (see 4.8).
Latvian: Lietojot celekoksibu, tika zinots par smagam hipersensitivitates reakcijam (anafilaksi un angioneirotisko tusku) (skatit apakšpunktu 4.8).
English: Reproductive system and breast disorders Very rare: menstrual disorder NOS
Latvian: Reproduktivas sistemas un kruts slimibas: Loti reti: menstruala cikla traucejumi (nespecifiski)
English: Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.
Latvian: Osteoartrita un reimatoida artrita radita iekaisuma un sapju simptomatiska terapija.
English: Common: dizziness
Latvian: Bieži: izsitumi
English: - recommended follow up measures to further investigate the safety of celecoxib.
Latvian: - iesaka turpinat izpetitu celecoxib drošibas petijumus.
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.
Latvian: Divos 12-nedelu petijumos procentualais pacientu skaits ar endoskopiski konstatetam gastroduodenalam culam placebo grupa un celekoksiba grupas, lietojot 200 mg divas reizes diena un 400 mg divas reizes diena, bija bez butiskas atškiribas.
English: As for NSAIDs, the risk of acute renal insufficiency, which is usually reversible, may be increased in some patients with compromised renal function (e.g. dehydrated patients or elderly patients)when ACE inhibitors or angiotensin II receptor antagonists are combined with NSAIDs, including celecoxib.
Latvian: Dažiem pacientiem ar traucetu nieru funkciju (piemeram, dehidratetiem vai gados vecakiem pacientiem), lietojot NSPL, tai skaita celekoksibu, kombinacija ar AKE inhibitoriem vai angiotensina II receptoru antagonistiem, var but paaugstinats akutas nieru mazspejas risks, kas parasti ir atgriezenisks.
English: Plasma concentrations of celecoxib are probably markedly increased in such patients.
Latvian: Celekoksiba koncentracija plazma šadiem pacientiem, jadoma, ir stipri palielinata.
English: Celecoxib may mask fever and other signs of inflammation.
Latvian: Celekoksibs var masket drudzi un citas iekaisuma pazimes.
English: Clinical 3
Latvian: 3. kliniskais posms
English: Inflammatory bowel disease.
Latvian: Iekaisiga zarnu slimiba.
English: The metabolic capacity in patients with mild to moderate impairment was best correlated to their albumin values.
Latvian: Metaboliska kapacitate pacientiem ar vieglu lidz merenu bojajumu vislabak koreleja ar albuminu limeni.
English: Effects of celecoxib on other drugs
Latvian: Celekoksiba ietekme uz citiem preparatiem.
English: Clinical 4
Latvian: 4. kliniskais posms
English: Ear and labyrinth disorders Uncommon: tinnitus Very rare: decreased hearing
Latvian: Ausu un labirinta bojajumi Retak: tinnits
English: 6.3 Shelf-life 3 years.
Latvian: 6.3 Uzglabašanas laiks
English: Additional reactions reported from post-marketing experience in >70 million treated patients include headache, nausea and arthralgia, and the reactions included as very rare, in italics in the list below.
Latvian: Ieklautas papildus blakusparadibas no pecregistracijas uzraudziba sanemtiem zinojumiem, ieskaitot galvassapes, sliktu dušu un artralgiju un ieskaitot loti retas blakusparadibas, kas uzskaititas zemak kursiva, no >70 miljoniem arstetu pacientu.
English: Investigations Uncommon: increased SGOT and SGPT, increased creatinine, BUN increased
Latvian: Izmeklejumi Retak: palielinats ALAT un ASAT, palielinats kreatinins, paaugstinats urinvielas slapeklis asinis (BUN)
English: 5.1 Pharmacodynamic properties
Latvian: 5.1 Farmakodinamiskas ipašibas
English: Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with celecoxib.
Latvian: Ar celekoksibu arstetiem pacientiem noverotas gastrointestinala trakta augšejas dalas komplikacijas [perforacija, ulceracija vai asinošana (PUA)], daži gadijumi beigušies ar fatalu iznakumu.
English: Therefore, the combination should be administered with caution, especially in the elderly.
Latvian: Tapec ši kombinacija ir ordinejama piesardzigi, ipaši pacientiem gados.
English: COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
Latvian: Cilvekiem COX-2 konstateta audos ap kunga culam, tacu tas saistiba ar culu dzišanu nav pieradita.
English: Capsules 200 mg contain lactose monohydrate, sodium lauryl sulphate, povidone K30, croscarmellose sodium and magnesium stearate.
Latvian: Kapsulas apvalks satur želatinu, titana dioksidu E171; tinte satur indigokarminu E132. 200 mg kapsulas satur laktozes monohidratu, natrija laurilsulfatu, povidonu K30, natrija kroskarmelozi un magnija stearatu.
English: Rare: duodenal, gastricoesophageal, intestinal and colonic ulceration, dysphagia, intestinal perforation, oesophagitis, melaena
Latvian: Retak: aizcietejums, atraugas, gastrits, stomatits, vemšana, gastrointestinala iekaisuma paasinajums Reti: duodena, kunga, baribas vada, tievo zarnu un resnas zarnas ulceracija, disfagija, zarnu perforacija, ezofagits, melena
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).
Latvian: Ilgtermina placebo-kontroleta petijuma sporadiskas adenomatozas polipozes pacientiem, lietojot celekoksibu 200 mg divas reizes diena un 400 mg divas reizes diena, konstateja paaugstinatu nopietnu kardiovaskularo notikumu, galvenokart miokarda infarktu, skaitu salidzinajuma ar placebo (skatit 5.1).
English: As the cardiovascular risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
Latvian: Ta ka celekoksiba kardiovaskularais risks var pieaugt saistiba ar devas un iedarbibas ilguma pieaugumu, tad ir jalieto zemaka efektiva dienas deva pec iespejas isaku laiku.
English: Pharmacodynamic interactions
Latvian: Farmakodinamiska mijiedarbiba
English: Greece
Latvian: Griekija
English: There is no clinical experience of overdose.
Latvian: Attieciba uz pardozešanu kliniskas pieredzes nav.
English: The maximum recommended daily dose is 400 mg for both indications.
Latvian: Maksimala ieteicama dienas deva abu indikaciju gadijumos ir 400 mg. {Izgudrotais nosaukums} var ienemt ešanas laika vai starp edienreizem.
English: Celecoxib exhibits dose- and time-independent pharmacokinetics in the therapeutic dose range.
Latvian: Celekoksibam terapeitisko devu diapazona piemit no devas un la ika neatkariga farmakokinetika.
English: Denmark
Latvian: Danija
English: As with other drugs known to inhibit prostaglandin synthesis fluid retention and oedema have been observed in patients taking celecoxib.
Latvian: Tapat ka ar citiem preparatiem, kas inhibe prostaglandinu sintezi, pacientiem, kuri lieto celekoksibu, noverota škidruma aizture un tuska.
English: Severe renal impairment is contraindicated.
Latvian: Smaga nieru mazspeja ir kontrindikacija.
English: Thus caution is advised when treating patients with renal impairment.
Latvian: Ieteicama uzmaniba arstejot pacientus ar nieru mazspeju.
English: Patients known to be CYP2C9 poor metabolisers should be treated with caution.
Latvian: Pacienti, par kuriem zinams, ka vini sava CYP 2C9 del ir “vaji metabolizetaji”, jaarste piesardzigi.
English: Vascular disorders Uncommon: hypertension, hypertension aggravated
Latvian: Asinsvadu sistemas traucejumi Retak: hipertensija, hipertensijas paasinajums Reti: išemisks insults*
English: - In the posology section it is recommended to use of the lowest effective dose, for the shortest possible duration, and that the need for pain relief should be re-evaluated frequently.
Latvian: - devu sadala ir ieteikts lietot vismazako efektivo devu, isaka, iespejama laika posma un pretsapju zalu pielietojums ir regula ri jaizverte.
English: 4.8 Undesirable effects
Latvian: 4.8 Nevelamas blakusparadibas
English: A dose dependent effect on TxB2 formation has been observed after high doses of celecoxib.
Latvian: Pec lielam celekoksiba devam noverota no devas atkariga ietekme uz TxB2 veidošanos.
English: Member State
Latvian: Dalibvalsts
English: 6 PHARMACEUTICAL PARTICULARS
Latvian: FARMACEITISKA INFORMACIJA
English: There is little experience of celecoxib in renal impairment.
Latvian: Pieredze celekoksiba lietošana nieru mazspejas gadijuma ir maza.
English: Treatment should be initiated at half the recommended dose in patients with moderate liver impairment (with serum albumin 25-35g/L).
Latvian: Pacientiem ar merenu aknu bojajumu (seruma albumins 25-35 g/l) arstešana butu jauzsak ar pusi no ieteicamas devas.
English: Respiratory, thoracic and mediastinal disorders Common: pharyngitis, rhinitis Uncommon: cough, dyspnoea Very rare: bronchospasm.
Latvian: Retak: klepus, elpas trukums Loti reti: bronhospazma
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).
Latvian: Pec petijumu datiem, tapat ka citu NSPIL lietošanas gadijumos tad, ja celekoksibu lieto kombinacija ar mazam acetilsalicilskabes devam, gastrointestinalas ulceracijas un citu gastrointestinalo komplikaciju risks ir lielaks neka tad, ja celekoksibu lieto vienu pašu (skatit apakšpunktu
English: Blood and the lymphatic system disorders Uncommon: anaemia Rare: leucopenia, thrombocytopenia Very rare: pancytopenia.
Latvian: Reti: leikopenija, trombocitopenija Loti reti: pancitopenija
English: Common: rash
Latvian: Retak: natrene
English: In a peri-post natal study in rats, pup toxicity was observed.
Latvian: Viena perinatala un postnatala petijuma ar žurkam tika noverota toksiska ietekme uz mazuliem.
English: Therefore, patients on lithium treatment should be closely monitored when celecoxib is introduced or withdrawn.
Latvian: Tadel, pacienti, kas lieto litiju butu cieši janovero, kad uzsak vai beidz celekoksiba lietošanu.
English: 5 PHARMACOLOGICAL PROPERTIES
Latvian: FARMAKOLOGISKAS IPAŠIBAS
English: Pack size
Latvian: Saturs
English: The full EPAR for Copalia HCT can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Latvian: Pilns Copalia HCT teksts ir atrodams aģentūras tīmekļa vietnē: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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.
Latvian: Copalia HCT lieto iekšķīgi pa vienai tabletei vienreiz dienā, vienā un tai pašā dienas laikā un, vēlams, no rīta.
English: This is a summary of the European public assessment report (EPAR) for Copalia HCT.
Latvian: Šis ir Eiropas Publiskā novērtējuma ziņojuma (EPAR) kopsavilkums par Copalia HCT.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Copalia HCT on 4 November 2009.
Latvian: Eiropas Komisija 2009. gada 4. novembrī izsniedza Copalia HCT reģistrācijas apliecību, kas derīga visā Eiropas Savienībā.
English: The combination of the three active substances has an additive effect, reducing the blood pressure more than the individual medicines alone.
Latvian: Triju aktīvo vielu kombinācijai piemīt aditīva iedarbība, pazeminot asinsspiedienu vairāk nekā katrām zālēm atsevišķi.
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.
Latvian: Tajā ir paskaidrots, kā Cilvēkiem paredzēto zāļu komiteja (CHMP) novērtēja šīs zāles pirms sniegt pozitīvu atzinumu par reģistrācijas apliecības piešķiršanu un ieteikumus par Copalia HCT lietošanu.
English: The three active substances in Copalia HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
Latvian: Copalia HCT trīs aktīvās vielas ir prethipertensijas zāles, ko jau lieto Eiropas Savienībā (ES).
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.
Latvian: Attiecībā uz visām devām Copalia HCT atbilda arī prasībām, pierādot, ka tās ir salīdzināmas ar aktīvo vielu kombinācijām, lietojot tās atsevišķi.
English: For more information about treatment with Copalia HCT, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Latvian: Plašāka informācija par ārstēšanu ar Copalia HCT pieejama zāļu lietošanas instrukcijā (kas arī ir EPAR daļa) vai sazinoties ar ārstu vai farmaceitu.
English: Patients received either Copalia HCT or one of the three combinations containing only two of the active substances for eight weeks.
Latvian: Pacienti astoņu nedēļu laikā saņēma Copalia HCT vai vienu no trim kombinācijām, kuru sastāvā bija tikai divas aktīvās vielas.
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.
Latvian: Vidējais asinsspiediena samazinājums bija apmēram 39,7/24,7 mmHg pacientiem, kuri lietoja Copalia HCT, salīdzinājumā ar 32/19,7 mmHg, 33,5/21,5 mmHg un 31,5/19,5 mmHg pacientiem, kuri lietoja attiecīgi valsartāna/hidrohlortiazīda kombināciju, valsartāna/amlodipīna kombināciju un hidrohlortiazīda/amlodipīna kombināciju.
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.
Latvian: Copalia HCT lietojamā deva ir tāda pati kā triju atsevišķu aktīvo vielu devas, ko pacients lietojis pirms tam.
English: Copalia HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide.
Latvian: Copalia HCT ir zāles, kas satur trīs aktīvās vielas - amlodipīnu, valsartānu un hidrohlortiazīdu.
English: The CHMP therefore decided that Copalia HCT's benefits are greater than its risks and recommended that it be given marketing authorisation.
Latvian: Tāpēc HMP nolēma, ka pacienta ieguvums, lietojot Copalia HCT, pārsniedz šo zāļu radīto risku, un ieteica izsniegt šo zāļu reģistrācijas apliecību.