FrancophonIA/ELRC3.0 huggingface dataset:
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: What you need to know before you receive KRYSTEXXA Do not use KRYSTEXXA
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo KRYSTEXXA
English: Sodium intake KRYSTEXXA contains 4.2 mg sodium (less than 1 mmol) per dose (essentially sodium free).
Slovenian: Vnos natrija Zdravilo KRYSTEXXA vsebuje 4,2 mg natrija (manj kot 1 mmol) na odmerek (skoraj brez natrija).
English: • 1 ml of KRYSTEXXA should be injected into a single 250 ml bag of sodium chloride 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%) solution for injection or infusion.
Slovenian: • 1 ml zdravila KRYSTEXXA je treba injicirati v eno 250-mililitrsko vrečko raztopine natrijevega klorida 4,5 mg/ml (0,45 %) ali 9 mg/ml (0,9 %) za injiciranje ali infundiranje.
English: The most common signs and symptoms of generalised infusion reactions were: hives, shortness of breath, redness in the face, sweating, chest discomfort or pain, chills, and high blood pressure.
Slovenian: Najpogostejši znaki in simptomi generaliziranih reakcij na infundiranje so: koprivnica, kratka sapa, rdečina na obrazu, potenje, neudobje ali bolečina v prsnem košu, mrzlica in visok krvni tlak.
English: For the full list of excipients see section 6.1
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: No formal studies were conducted to examine the effects of hepatic impairment.
Slovenian: Uradnih študij za proučevanje učinkov jetrne okvare niso izvedli.
English: Clearance was 0.0145 L/h with a range of 0.00904 - 0.0229 for no increase in anti-pegloticase antibodies and 0.0193 L/h with a range of 0.00675 - 0.0340 for an increase in anti-pegloticase antibodies.
Slovenian: Očistek pri odsotnosti povečanja protiteles proti peglotikazi je bil 0,0145 l/h z razponom 0,00904-0,0229, pri povečanju ravni protiteles proti peglotikazi pa 0,0193 l/h z razponom 0,00675-0,0340.
English: Pegloticase 8 mg every 2 weeks Pegloticase 8 mg every 4 weeks Placebo
Slovenian: GOUT peglotikaza 8 mg vsaka 2 tedna 42 peglotikaza 8 mg vsake 4 tedne 43 placebo
English: No dose adjustment is needed for patients 65 years of age and older.
Slovenian: Pri bolnikih, starih 65 let ali več, ni treba prilagoditi odmerka.
English: • The infusion bag containing the diluted KRYSTEXXA solution should be inverted a number of times gently to ensure thorough mixing.
Slovenian: • Infuzijsko vrečko z razredčeno raztopino zdravila KRYSTEXXA je treba večkrat nežno obrniti,
English: The most common signs and symptoms of systemic infusion reactions are: urticaria, dyspnoea, flushing, hyperhidrosis, chest discomfort or pain, chills, and hypertension.
Slovenian: Najpogostejši znaki in simptomi sistemskih reakcij na infundiranje so: urtikarija, dispneja, zardevanje, hiperhidroza, neugodje ali bolečina v prsnem košu, mrzlica in hipertenzija.
English: Taking into account the PRAC Assessment Report on the PSUR for pegloticase, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni redno posodobljenih poročil o varnosti zdravila (PSUR) za pegloticazo je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: Common side effects (may affect up to 1 in 10 people): high blood sugar levels, vomiting, joint swelling, flu-like symptoms
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri do 1 od 10 bolnikov): visoka raven sladkorja v krvi, bruhanje, otekanje sklepov, gripi podobni simptomi.
English: Your doctor will also test your blood to measure uric acid before your next dose to make sure that you should continue receiving KRYSTEXXA.
Slovenian: Zdravnik bo opravil tudi krvne preiskave, s katerimi bo pred naslednjim odmerkom preveril raven sečne kisline in s čimer se bo prepričal, da lahko nadaljujete prejemanje zdravila KRYSTEXXA.
English: In clinical trials, the mean plasma uric acid (PUA) levels fell to 0.7 mg/dl approximately 24 hours following the first dose of pegloticase in patients treated with KRYSTEXXA 8 mg every 2 weeks compared with a mean PUA of 8.2 mg/dl in the placebo-treated patients.
Slovenian: V kliničnih preskušanjih so povprečne ravni sečne kisline v plazmi padle na 0,7 mg/dl približno 24 ur po prvem odmerku peglotikaze pri bolnikih, zdravljenih z 8 mg zdravila KRYSTEXXA vsaka 2 tedna, v primerjavi s povprečnimi ravnmi sečne kisline v serumu 8,2 mg/dl pri bolnikih, ki so prejemali placebo.
English: Very common side effects (may affect more than 1 in 10 people): hives, skin rash, itchy, dry or irritated skin, nausea
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): koprivnica, kožni izpuščaj, srbeča, suha ali razdražena koža, slabost s siljenjem na bruhanje.
English: In clinical trials, anti-pegloticase antibodies (IgM and IgG) developed in 89% of patients treated with KRYSTEXXA 8 mg every 2 weeks and 15% in the placebo group.
Slovenian: V kliničnih preskušanjih so se protitelesa proti peglotikazi (IgM in IgG) razvila pri 89 % bolnikov, ki so prejemali 8 mg zdravila KRYSTEXXA vsaka 2 tedna, in pri 15 % bolnikov, ki so prejemali placebo.
English: It is therefore recommended to discontinue oral urate-lowering medications before starting treatment and not institute therapy with oral uratelowering agents while taking KRYSTEXXA.
Slovenian: Zato se priporoča, da se pred začetkom zdravljenja prekine jemanje peroralnih zdravil za zniževanje ravni uratov in da se ta zdravila ne uvedejo med jemanjem zdravila KRYSTEXXA.
English: Allantoin is eliminated by renal excretion, thereby lowering serum uric acid.
Slovenian: Alantoin se izloča skozi ledvice, kar zmanjša koncentracijo sečne kisline v serumu.
English: The volume of distribution was 4.45 L with a range of 2.625.89 for no increase in anti-pegloticase antibodies and 5.77 L with a range of 2.77 - 10.6 for an increase in anti-pegloticase antibodies.
Slovenian: Volumen porazdelitve pri odsotnosti povečanja protiteles proti peglotikazi je bil 4,45 l z razponom 2,62-5,89, pri povečanju ravni protiteles proti peglotikazi pa 5,77 l z razponom 2,77-10,6.
English: No case of overdose with KRYSTEXXA has been reported during clinical development.
Slovenian: Med kliničnim razvojem niso poročali o nobenem primeru prevelikega odmerjanja zdravila KRYSTEXXA.
English: KRYSTEXXA contains sodium
Slovenian: Zdravilo KRYSTEXXA vsebuje natrij.
English: In clinical trials, the percentage of patients that had flares in the first 3 months was 75% in patients treated with KRYSTEXXA 8 mg every 2 weeks compared with 54% in placebo-treated patients.
Slovenian: V kliničnih preskušanjih je imelo napade v prvih 3 mesecih 75 % bolnikov, zdravljenih z 8 mg zdravila KRYSTEXXA vsaka 2 tedna, v primerjavi s 54 % bolnikov, zdravljenih s placebom.
English: How much KRYSTEXXA is given
Slovenian: Koliko zdravila KRYSTEXXA boste prejeli
English: KRYSTEXXA contains the active substance pegloticase.
Slovenian: Zdravilo KRYSTEXXA vsebuje zdravilno učinkovino peglotikazo.
English: Therefore, monitoring of serum uric acid level is required prior to each infusion.
Slovenian: Zato je treba pred vsakim infundiranjem preveriti raven sečne kisline v serumu.
English: Your doctor will test your blood to measure uric acid levels before each dose to make sure that you should continue receiving KRYSTEXXA.
Slovenian: Zdravnik bo pred vsakim odmerjanjem zdravila opravil preiskavo krvi, s kateri bo izmeril ravni sečne kisline in s čimer se bo prepričal, da lahko nadaljujete prejemanje zdravila KRYSTEXXA.
English: Warnings and precautions Talk to your doctor or nurse before using KRYSTEXXA:
Slovenian: Pred začetkom uporabe zdravila KRYSTEXXA se posvetujte s svojim zdravnikom ali medicinsko sestro:
English: The most common signs and symptoms of local infusion reactions are: erythema, pruritus, and rash.
Slovenian: Najpogostejši znaki in simptomi lokalnih reakcij na infundiranje so: eritem, pruritus in izpuščaj.
English: The maximum dose that has been administered as a single intravenous dose during clinical studies was 12 mg. A post-marketing report documented administration of the contents of 2 vials (16 mg) without any adverse reaction related to KRYSTEXXA administration.
Slovenian: Poročilo iz obdobja po prihodu zdravila na trg je vsebovalo tudi primer uporabe vsebine 2 vial (16 mg) brez kakršnih koli neželenih učinkov, povezanih z dajanjem zdravila KRYSTEXXA.
English: Disodium hydrogen phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride
Slovenian: 6.1 Seznam pomožnih snovi dinatrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat dihidrat natrijev klorid voda za injekcije
English: Retreatment with KRYSTEXXA
Slovenian: Ponovno zdravljenje z zdravilom KRYSTEXXA
English: infusion) and your treatment will take about 2 hours or sometimes longer.
Slovenian: Zdravilo KRYSTEXXA se počasi injicira v veno (intravensko infundiranje), zdravljenje pa poteka približno 2 uri ali včasih dlje.
English: Disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, water for injections
Slovenian: dinatrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat dihidrat, natrijev klorid, voda za injekcije koncentrat za raztopino za infundiranje 1 viala intravenska uporaba
English: Medicinal product subject to medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: KRYSTEXXA has not been studied in children or adolescents under 18 years of age.
Slovenian: Zdravila KRYSTEXXA niso proučevali pri otrocih in mladostnikih, mlajših od 18 let, zato se to zdravilo ne priporoča v tej starostni skupini.
English: The MAH shall complete, within the stated timeframe, the following measures:
Slovenian: • Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
English: Among the other secondary endpoints, reduction from baseline in the number of tender and swollen joints were observed in patients treated with KRYSTEXXA every 2 weeks while there was little change in patients on placebo.
Slovenian: Pri drugih sekundarnih opazovanih dogodkih so pri bolnikih, zdravljenih z zdravilom KRYSTEXXA vsaka 2 tedna, opazili zmanjšanje števila občutljivih in oteklih sklepov v primerjavi z izhodiščem, medtem ko so bile pri bolnikih, ki so prejemali placebo, spremembe majhne.
English: • If you are allergic to pegloticase, or other uricases or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila KRYSTEXXA • če ste alergični na peglotikazo ali druge urikaze ali katero koli sestavino tega zdravila (navedeno
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 8 mg/1 ml
English: Justification for not including Braille accepted
Slovenian: PODATKI O BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
English: The most common signs and symptoms of local infusion reactions were: redness at the injection site, itching, and rash.
Slovenian: Najpogostejši znaki in simptomi lokalnih reakcij na infundiranje so: rdečina na mestu injiciranja, srbenje in izpuščaj.
English: • The other ingredients are disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride and water for injections.
Slovenian: • Druge sestavine zdravila so dinatrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat dihidrat,
English: From the nonclinical studies, the elimination of pegloticase is via renal/urinary excretion.
Slovenian: Predklinične študije so pokazale, da se peglotikaza izloča prek ledvic in z urinom.
English: KRYSTEXXA, once diluted with 250 ml of sodium chloride solution, 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%), is administered as an intravenous infusion over no less than 2 hours, at a flow rate of approximately 2 ml/minute.
Slovenian: Po redčenju z 250 ml raztopine natrijevega klorida, 4,5 mg/ml (0,45 %) ali 9 mg/ml (0,9 %) se zdravilo KRYSTEXXA intravensko infundira v obdobju, daljšem od 2 ur, pri čemer mora biti hitrost pretoka približno 2 ml/minuto.
English: How KRYSTEXXA works
Slovenian: Kako deluje zdravilo KRYSTEXXA
English: Your doctor may test you for G6PD before you start KRYSTEXXA.
Slovenian: Pred začetkom zdravljenja z zdravilom KRYSTEXXA bo morda zdravnik pri vas opravil preiskavo G6PD.
English: Number of Patients with CR
Slovenian: Število bolnikov z razpoložljivimi podatki
English: The Pain scores using a visual analogue scale were 44.2 at baseline vs. 28.4 at Week 25 in patients treated with pegloticase 8 mg every 2 weeks compared to 53.9 vs. 57.2 in the placebo group (p≤0.001).
Slovenian: Rezultat za bolečine z uporabo vizualne analogne lestvice je bil pri bolnikih, zdravljenih z 8 mg peglotikaze vsaka 2 tedna, 44,2 ob izhodišču in 28,4 po 25. tednu, pri skupini s placebom pa 53,9 oziroma 57,2 (p≤0,001).
English: Plasma Uric Acid < 6 mg/dl for at Least 80% of the Time During Months 3 and 6 Treatment Group
Slovenian: Preglednica 2: Raven sečne kisline v plazmi < 6 mg/dl vsaj 80 % časa med 3. in 6. mesecem Število (%) preskušancev, ki so izpolnili merila za odziv
English: Infusion-related reactions showed a tendency to occur in a greater proportion of patients with over 100 kg bodyweight.
Slovenian: Verjetneje je, da se bodo alergijske reakcije pojavile pri bolnikih s telesno maso, večjo od 100 kg.
English: Monitoring of serum uric acid level is required prior to each infusion.
Slovenian: Pred vsakim infundiranjem je treba preveriti raven sečne kisline v serumu.
English: KRYSTEXXA 8 mg concentrate for solution for infusion pegloticase
Slovenian: KRYSTEXXA 8 mg koncentrat za raztopino za infundiranje peglotikaza
English: Metabolism and nutrition disorders Common: Hyperglycaemia Cardiac disorders
Slovenian: Pogosti: hiperglikemija Občasni: hiperkaliemija
English: Lot
Slovenian: VIALA
English: Adverse Reactions System Organ Class
Slovenian: Preglednica 1: Neželeni učinki Organski sistem
English: Uncommon side effects: (may affect up to 1 in 100 people): worsening of a type of heart disease called congestive heart failure, skin infection, elevated potassium levels in the blood Frequency not known (cannot be estimated from available data): destruction of red blood cells If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri do 1 od 100 bolnikov): poslabšanje srčne bolezni, imenovane kongestivno srčno popuščanje, kožna okužba, povišana raven kalija v krvi.
English: KRYSTEXXA has little or no effect on your ability to drive.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo KRYSTEXXA nima učinka ali ima majhen učinek na sposobnost upravljanja vozil.
English: The HAQ-PGA scores were 42.4 at baseline vs. 27.1 at Week 25 in patients treated with pegloticase 8 mg every 2 weeks compared to 51.6 vs. 53.4 in the placebo group (p≤0.001).
Slovenian: Rezultat HAQ-PGA je bil pri bolnikih, zdravljenih z 8 mg peglotikaze vsaka 2 tedna, 42,4 ob izhodišču in 27,1 po 25. tednu, pri skupini s placebom pa 51,6 oziroma 53,4 (p≤0,001).
English: KRYSTEXXA does not need to be discontinued because of a gout flare.
Slovenian: Zaradi napada protina ni treba prekiniti uporabe zdravila KRYSTEXXA.
English: The HAQ-DI scores were 1.1 at baseline vs. 0.84 at Week 25 in patients treated with pegloticase 8 mg every 2 weeks compared to 1.2 vs. 1.3 in the placebo group (p≤0.01).
Slovenian: Rezultat HAQ-DI je bil pri bolnikih, zdravljenih z 8 mg peglotikaze vsaka 2 tedna, 1,1 ob izhodišču in 0,84 po 25. tednu, pri skupini s placebom pa 1,2 oziroma 1,3 (p≤0,01).
English: KRYSTEXXA 8 mg concentrate for solution for infusion
Slovenian: IME ZDRAVILA KRYSTEXXA 8 mg koncentrat za raztopino za infundiranje
English: How to store KRYSTEXXA
Slovenian: Shranjevanje zdravila KRYSTEXXA
English: How to use KRYSTEXXA
Slovenian: Kako se daje zdravilo KRYSTEXXA
English: The infusion bag containing diluted KRYSTEXXA should not be shaken.
Slovenian: Infuzijska vrečka, ki vsebuje razredčeno zdravilo
English: th infusion.
Slovenian: Napadi protina
English: Intraperitoneal use
Slovenian: peresnikov
English: vials (glass)
Slovenian: 3 viale
English: EU/1/97/030/202 Insuman Implantable
Slovenian: EU/1/97/030/202 Insuman Implantable raztopina za infundiranje intraperitonealna uporaba
English: EU/1/97/030/203 Insuman Implantable
Slovenian: EU/1/97/030/203 Insuman Implantable raztopina za infundiranje intraperitonealna uporaba
English: EU/1/97/030/053 Insuman Infusat 100 IU/ml
Slovenian: EU/1/97/030/053 Insuman Infusat
English: EU/1/97/030/054 Insuman Infusat 100 IU/ml vials (glass)
Slovenian: EU/1/97/030/050 Insuman Comb 100 i.e./ml suspenzija za injiciranje
English: 1 pre-filled syringe
Slovenian: 1 napolnjena injekcijska
English: Recombinant Hepatitis B surface antigen (S protein), adsorbed Inactivated type 1 Poliovirus Inactivated type 2 Poliovirus Inactivated type 3 Poliovirus
Slovenian: 1 napolnjena injekcijska brizga + 1 priložena injekcijska igla davični toksoid tetanusni toksoid antigeni bordetele pertusis toksoid bordetele pertusis filamentozni hemaglutinin pertaktin površinski antigen virusa hepatitisa B, rekombinantni (S protein)
English: Invented name Strength Pharmaceutical
Slovenian: Farmacevtska oblika Pot uporabe Ovojnina
English: The European Commission granted a marketing authorisation valid throughout the EU for Copalia on 16 January 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Copalia, veljavno po vsej Evropski uniji, izdala 16. januarja 2007.
English: The full EPAR for Copalia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Copalia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Copalia
Slovenian: Druge informacije o zdravilu Copalia
English: Copalia amlodipine / valsartan
Slovenian: Copalia amlodipin/valsartan
English: This is a summary of the European public assessment report (EPAR) for Copalia.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Copalia.
English: The CHMP decided that Copalia's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Copalia večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: What benefit has Copalia shown during the studies?
Slovenian: Kakšne koristi je zdravilo Copalia izkazalo med študijami?
English: For more information about treatment with Copalia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Copalia preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
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.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The most common side effects with Copalia (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
Slovenian: Najpogostejši neželeni učinki zdravila Copalia (opaženi pri 1 do 10 bolnikih od 100) so glavobol, nazofaringitis (vnetje nosne votline in grla), influenca (gripa), hipokaliemija (nizke ravni kalija v krvi), različne vrste edemov (oteklin), utrujenost, pordelost, astenija (oslabelost) in navali vročine.
English: What is the risk associated with Copalia?
Slovenian: Kakšna tveganja so povezana z zdravilom Copalia?
English: The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Copalia and people taking the separate medicines.
Slovenian: Družba je prav tako predložila dokaze o tem, da sta bili ravni amlodipina in valsartana v krvi enaki pri bolnikih, ki so jemali zdravilo Copalia, in bolnikih, ki so obe zdravilni učinkovini jemali ločeno.
English: Copalia is taken by mouth as one tablet once a day with some water.
Slovenian: Zdravilo Copalia se jemlje peroralno, in sicer se zaužije ena tableta na dan z malo vode.
English: The dose of Copalia to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Slovenian: Odmerek zdravila Copalia, ki ga je treba vzeti, je odvisen od odmerkov amlodipina ali valsartana, ki ju je bolnik jemal prej.
English: For the full list of all side effects reported with Copalia, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Copalia, glejte navodilo za uporabo.
English: Copalia is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone.
Slovenian: Zdravilo Copalia se uporablja pri bolnikih, ki imajo esencialno hipertenzijo (visok krvni tlak), ki je ni mogoče ustrezno uravnati samo z amlodipinom ali valsartanom.
English: Copalia must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure).
Slovenian: Zdravila Copalia prav tako ne smejo jemati bolniki, ki imajo hude težave z jetri ali izločanjem žolča, bolniki z nekaterimi obolenji srca ter s hudo hipotenzijo (nizkim krvnim tlakom).
English: Two studies (involving almost 3,200 patients) compared amlodipine, valsartan or a combination of both substances with placebo (a dummy treatment).
Slovenian: V dveh študijah (s skoraj 3 200 bolniki) so amlodipin, valsartan ali kombinacijo obeh učinkovin primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: Copalia must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives' class, to valsartan, or to any of the other ingredients.
Slovenian: Zdravila Copalia ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) amlodipin ali druga zdravila iz razreda derivatov dihidropiridina, valsartan ali katero koli drugo sestavino zdravila.
English: Why has Copalia been approved?
Slovenian: Zakaj je bilo zdravilo Copalia odobreno?
English: Copalia must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Slovenian: Zdravilo Copalia se prav tako ne sme uporabljati v kombinaciji z zdravili, ki vsebujejo aliskiren (ki se uporablja za zdravljenje esencialne hipertenzije), pri bolnikih s sladkorno boleznijo tipa 2 ali zmerno do hudo ledvično okvaro.
English: Copalia is a medicine that contains two active substances, amlodipine and valsartan.
Slovenian: Copalia je zdravilo, ki vsebuje dve zdravilni učinkovini, amlodipin in valsartan.