FrancophonIA/ELRC3.0 huggingface dataset:
English: • polycythaemia vera in adults who are resistant or intolerant to treatment with the medicine hydroxyurea.
Croatian: • policitemije vere u odraslih osoba koje su otporne na terapiju hidroksiureom ili je ne podnose.
English: In polycythaemia vera, 21% (23 out of 110) of patients given Jakavi showed an improvement after 8 months of treatment, compared with 1% (1 out of 112) of patients given the best available treatment.
Croatian: U slučaju policitemije vere, 21 % bolesnika (23 od 110) koji su primali lijek Jakavi pokazalo je poboljšanje nakon osam mjeseci terapije, u usporedbi s 1 % bolesnika (1 od 112) koji su primali najbolju dostupnu terapiju.
English: The CHMP decided that Jakavi's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Jakavi nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Why has Jakavi been approved?
Croatian: Zašto je lijek Jakavi odobren?
English: In the second study, the target reduction in spleen size was achieved in 29% of patients treated with Jakavi (41 out of 144) compared with 0% of patients receiving the best available treatment (0 out of 72).
Croatian: U drugom ispitivanju ciljno smanjivanje veličine slezene postignuto je kod 29 % bolesnika liječenih lijekom Jakavi (41 od 144), u usporedbi s 0 % bolesnika koji su primali najbolju dostupnu terapiju (0 od 72).
English: In polycythaemia vera, Jakavi was studied in one main study which involved 222 patients who were resistant or intolerant to treatment with hydroxyurea.
Croatian: U slučaju policitemije vere, Jakavi je ispitan u jednom glavnom ispitivanju koje je uključivalo 222 bolesnika koji su bili otporni na terapiju hidroksiureom ili je nisu podnosili.
English: This study, which compared Jakavi with best available treatment, looked at the percentage of patients who showed improvement in their condition, measured as requiring none or no more than one phlebotomy (a procedure to remove excess blood from the body) and whose spleen reduced by at least 35% in size, after 8 months of treatment.
Croatian: U tom je ispitivanju, u kojem je lijek Jakavi uspoređen s najboljom dostupnom terapijom, promatran postotak bolesnika kod kojih je došlo do poboljšanja stanja tako da venepunkcija (postupak puštanja prekomjerne količine krvi iz tijela) više nije potrebna ili je potrebna samo jedna, te čija se slezena smanjila barem 35 % nakon osam mjeseci terapije.
English: The first study compared Jakavi with placebo (a dummy treatment).
Croatian: U prvom je ispitivanju lijek Jakavi uspoređen s placebom (prividnim liječenjem).
English: Jakavi can be used in three types of the disease: primary myelofibrosis (also known as chronic idiopathic myelofibrosis, where the cause is unknown), post-polycythaemia vera myelofibrosis (where the disease is linked to an overproduction of red blood cells) and postessential thrombocythaemia myelofibrosis (where the disease is linked to an overproduction of platelets, components that help the blood to clot).
Croatian: Jakavi se može koristiti kod triju tipova te bolesti: primarne mijelofibroze (također poznate kao kronična idiopatska mijelofibroza čiji je uzrok nepoznat), mijelofibroze nakon policitemije vere (kod koje je bolest povezana s prekomjernim stvaranjem eritrocita) i mijelofibroze nakon esencijalne trombocitemije (kod koje je bolest povezana s prekomjernim stvaranjem trombocita, tjelešaca koja pomažu zgrušavanje krvi).
English: What is Jakavi used for?
Croatian: Za što se Jakavi koristi?
English: In myelofibrosis and polycythaemia vera, there is too much JAK activity, leading to the abnormal production of blood cells.
Croatian: Kod mijelofibroze i policitemije vere dolazi do prekomjerne aktivnosti JAK-ova, što uzrokuje abnormalno stvaranje krvnih stanica.
English: In myelofibrosis, the most common side effects with Jakavi (seen in more than 1 patient in 10) are thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils), urinary tract infections (infection of the structures that carry urine), bleeding, bruising, weight gain, hypercholesterolaemia (high blood cholesterol levels), dizziness, headache and raised liver enzyme levels.
Croatian: Kod mijelofibroze, najčešće nuspojave pri primjeni lijeka Jakavi (mogu se pojaviti kod više od 1 na 10 bolesnika) su trombocitopenija (nizak broj trombocita u krvi), anemija (nizak broj eritrocita), neutropenija (niska razina neutrofila), infekcije urinarnog trakta (infekcija struktura koje prenose urin), krvarenje, nastanak modrica, porast tjelesne težine, hiperkolesterolemija (visoka razina kolesterola u krvi), omaglica, glavobolja i povišene razine jetrenih enzima.
English: A lower dose should be used in certain cases, including in patients reduced liver function or severely reduced kidney function, and in patients taking certain other medicines.
Croatian: Kod bolesnika s oštećenom funkcijom jetre ili teško oštećenom funkcijom bubrega te kod onih koji uzimaju određene druge lijekove potrebno je koristiti nižu dozu.
English: In polycythaemia vera, the most common side effects with Jakavi (seen in more than 1 patient in 10) are thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), bleeding, bruising, hypercholesterolaemia (high blood cholesterol levels), hypertriglyceridemia (high blood fat levels), dizziness, raised liver enzyme levels and high blood pressure.
Croatian: Kod policitemije vere, najčešće nuspojave pri primjeni lijeka Jakavi (mogu se pojaviti kod više od 1 na 10 bolesnika) su trombocitopenija (nizak broj trombocita u krvi), anemija (nizak broj eritrocita), krvarenje, nastanak modrica, hiperkolesterolemija (visoka razina kolesterola u krvi), hipertrigliceridemija (visoka razina masnoće u krvi) omaglica, povišene razine jetrenih enzima i visok krvni tlak.
English: For the full list of all side effects and restrictions with Jakavi, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Jakavi potražite u uputi o lijeku.
English: How does Jakavi work?
Croatian: Kako djeluje Jakavi?
English: How has Jakavi been studied?
Croatian: Kako je Jakavi ispitivan?
English: What benefit has Jakavi shown during the studies?
Croatian: Koje su koristi lijeka Jakavi utvrđene u ispitivanjima?
English: How is Jakavi used?
Croatian: Kako se Jakavi koristi?
English: • At the request of the European Medicine Agency;
Croatian: • na zahtjev Europske agencije za lijekove;
English: Do not stop taking ADENURIC without the advice of your doctor even if you feel better.
Croatian: Nemojte prestati uzimati ADENURIC bez savjetovanja s liječnikom, čak i ako se osjećate bolje.
English: Date of first authorisation: 21 April 2008 Date of latest renewal: 20 December 2012
Croatian: Datum posljednje obnove odobrenja: 20. prosinac 2012.
English: Your doctor might decide to permanently stop treatment with ADENURIC.
Croatian: Vaš liječnik može odlučiti trajno prekinuti liječenje ADENURICOM.
English: It may cause muscle problems and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown.
Croatian: Može uzrokovati probleme s mišićima i, osobito ako se istovremeno osjećate loše ili imate visoku temperaturu, može biti uzrokovano abnormalnom razgradnjom mišićnih stanica.
English: Should you experience allergic reactions to ADENURIC, stop taking this medicine (see also section 4).
Croatian: Ako se pojavi alergijska reakcija na ADENURIC, prestanite uzimati ovaj lijek (vidjeti i dio 4).
English: It is especially important to tell your doctor or pharmacist if you are taking medicines containing any of the following substances as they may interact with ADENURIC and your doctor may wish to consider necessary measures:
Croatian: Posebno je važno da obavijestite svog liječnika ili ljekarnika ako uzimate lijekove koji sadrže neku od sljedećih tvari, s obzirom na to da one mogu stupiti u interakciju s ADENURICOM i Vaš liječnik će možda morati poduzeti potrebne mjere:
English: The back of the blister pack is marked with the days of the week to help you check that you have taken a dose each day.
Croatian: Na stražnjoj strani blistera označeni su dani u tjednu, što će Vam pomoći da provjerite jeste li uzeti dozu svaki dan.
English: Not everyone gets flares, but you could get a flare-up even if you are taking ADENURIC, and especially during the first weeks or months of treatment.
Croatian: Napadi se neće pojaviti kod svih bolesnika, ali ih možete imati i ako uzimate ADENURIC, a posebno tijekom prvih tjedana ili mjeseci liječenja.
English: Excipient(s) with known effects:
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom:
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V.
English: Furthermore, the mean serum uric acid level was significantly lower with ADENURIC since the first 24 hours of treatment and at any following time point.
Croatian: Nadalje, srednja razina serumske mokraćne kiseline bila je značajno niža s ADENURICOM nakon prva 24 sata liječenja i u bilo kojoj točki vremena nakon toga.
English: Talk to your doctor before taking ADENURIC:
Croatian: Obratite se svom liječniku prije nego uzmete ADENURIC:
English: The safety and the efficacy of ADENURIC in children aged below the age of 18 years have not been established.
Croatian: Sigurnost i djelotvornost ADENURICA u djece do 18 godina nije ustanovljena.
English: What ADENURIC is and what it is used for
Croatian: Što je ADENURIC i za što se koristi
English: Plasma protein binding of the active metabolites ranges from about 82% to 91%.
Croatian: Vezanje aktivnih metabolita na proteine plazme je u rasponu od oko 82% do 91%.
English: • Do not use this medicine after the expiry date which is stated on the carton and the tablet blister foil after ‘EXP.'
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i foliji blistera iza oznake „EXP“.
English: The requirements for submission of periodic safety updated reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: • rash (including various types of rash, please see below under “uncommon” and “rare” sections)
Croatian: • osip (uključujući razne vrste osipa, molimo pogledajte niže u tekstu u dijelovima «manje česte nuspojave» i «rijetke nuspojave»)
English: If you take more ADENURIC than you should
Croatian: Ako uzmete više ADENURICA nego što ste trebali
English: About 69 % of patients required no treatment change to achieve a final stable treatment.
Croatian: Kod oko 69% bolesnika nije bilo potrebno mijenjati liječenje kako bi se postigao stabilan učinak.
English: Other medicines and ADENURIC
Croatian: Drugi lijekovi i ADENURIC
English: • If you are allergic to febuxostat or any of the other ingredients of this medicine (listed in section
Croatian: • ako ste alergični na febuksostat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: It is important to keep taking ADENURIC even if you have a flare, as ADENURIC is still working to lower uric acid.
Croatian: Važno je da nastavite uzimati ADENURIC čak i ako imate napad, s obzirom na to da ADENURIC i dalje djeluje na snižavanje razine mokraćne kiseline.
English: The efficacy and safety of ADENURIC in the prevention and treatment of Tumor Lysis Syndrome was evaluated in the FLORENCE (FLO-01) study.
Croatian: Djelotvornost i sigurnost ADENURICA u prevenciji i liječenju sindroma tumorske lize su ocijenjeni u FLORENCE (FLO-01) ispitivanju.
English: The effect of ADENURIC on human fertility is unknown.
Croatian: Učinak ADENURICA na plodnost u čovjeka nije poznat.
English: The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Croatian: Urez služi samo kako bi se olakšalo lomljenje tablete radi lakšeg gutanja, a ne da bi se podijelila na jednake doze.
English: Start taking ADENURIC two days before chemotherapy and continue its use according to your doctor's advice.
Croatian: Počnite uzimati ADENURIC dva dana prije kemoterapije i nastavite s primjenom prema uputi Vašeg liječnika.
English: ADENURIC is for adults.
Croatian: ADENURIC je za odrasle.
English: * p < 0.001 vs allopurinol, # p < 0.001 vs 80 mg
Croatian: * p < 0,001 u odnosu na alopurinol, # p < 0,001 u odnosu na 80 mg
English: Cardio-vascular disorders Treatment of chronic hyperuricaemia
Croatian: Kardiovaskularni poremećaji Liječenje kronične hiperuricemije
English: What ADENURIC is and what it is used for What you need to know before you take ADENURIC How to take ADENURIC
Croatian: Što je ADENURIC i za što se koristi Što morate znati prije nego počnete uzimati ADENURIC Kako uzimati ADENURIC
English: The score line on the 80 mg tablet is only there to help you break the tablet if you have difficulty swallowing it whole.
Croatian: Urez na tableti od 80 mg služi samo da Vam pomogne prelomiti tabletu ako je ne možete progutati cijelu.
English: ADENURIC should be started two days before the beginning of cytotoxic therapy and continued for a minimum of 7 days; however treatment may be prolonged up to 9 days according to chemotherapy duration as per clinical judgment.
Croatian: ADENURIC treba uvesti dva dana prije početka citotoksične terapije i nastaviti s uzimanjem najmanje 7 dana; međutim liječenje može biti produljeno do 9 dana u skladu s trajanjem kemoterapije, prema kliničkoj procjeni.
English: • severe swelling of the deeper layers of the skin, especially around the lips, eyes, genitals, hands, feet or tongue, with possible sudden difficult breathing
Croatian: • jako oticanje dubljih slojeva kože, osobito oko usana, očiju, genitalija, ruku, stopala ili jezika, s mogućom iznenadnom pojavom otežanog disanja
English: Patients should exercise caution before driving, using machinery or participating in dangerous activities until they are reasonably certain that ADENURIC does not adversely affect performance.
Croatian: Bolesnici trebaju postupati s oprezom tijekom upravljanja vozilima i strojevima i sudjelovanja u opasnim aktivnostima, sve dok nisu prilično sigurni da ADENURIC kod njih ne utječe negativno na provedbu tih aktivnosti.
English: • This medicine does not require any special storage conditions.
Croatian: • Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
English: • If you have or have had renal disease and/or serious allergic reaction to Allopurinol (a medication used for the treatment of Gout)
Croatian: • ako imate ili ste imali bubrežnu bolest i/ili ozbiljnu alergijsku reakciju na alopurinol (lijek za liječenje gihta)
English: 14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets
Croatian: 14 filmom obloženih tableta 28 filmom obloženih tableta 42 filmom obložene tablete 56 filmom obloženih tableta 84 filmom obložene tablete 98 filmom obloženih tableta
English: If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell that you are taking this medicine.
Croatian: Ako se pojave osip ili navedeni kožni simptomi, odmah se obratite liječniku za savjet i obavijestite ga da uzimate ovaj lijek.
English: What ADENURIC looks like and contents of the pack
Croatian: Kako ADENURIC izgleda i sadržaj pakiranja
English: ADENURIC 120 mg tablets is also used to treat and prevent high blood levels of uric acid that may occur when you start to receive chemotherapy for blood cancers.
Croatian: ADENURIC 120 mg tablete se koriste i za liječenje i prevenciju visoke razine mokraćne kiseline u krvi koja se može pojaviti kada počnete dobivati kemoterapiju za rak krvi.
English: This has not been observed in the pivotal clinical study with ADENURIC in the Tumor Lysis Syndrome.
Croatian: To nije primijećeno u pivotalnom kliničkom ispitivanju s ADENURICOM kod sindroma tumorske lize.
English: Overall, the FLORENCE trial did not highlight any particular safety concern in addition to the previous experience with ADENURIC in gout, with the exception of the following three adverse reactions (listed above in table 1).
Croatian: U FLORENCE ispitivanju se, općenito, nije istaknuo niti jedan poseban sigurnosni problem uz prethodno iskustvo s ADENURICOM kod gihta, osim sljedeće tri nuspojave (navedene iznad u tablici
English: Following multiple oral doses of ADENURIC, the Cmax and AUC were 24% and 12% higher in females than in males, respectively.
Croatian: Spol Nakon višekratnih oralnih doza ADENURIC, Cmax i AUC su bili 24%, odnosno 12% viši kod žena nego kod muškaraca.
English: Febuxostat tablets contain lactose.
Croatian: Tablete febuksostata sadrže laktozu.
English: Carcinogenesis, mutagenesis, impairment of fertility
Croatian: Karcinogeneza, mutageneza, smanjenje plodnosti
English: A. Menarini Pharma GmbH.
Croatian: Österreich A. Menarini Pharma GmbH.
English: Patheon France 40 boulevard de Champaret 38300 Bourgoin Jallieu France or
Croatian: Patheon France 40 boulevard de Champaret 38300 Bourgoin Jallieu Francuska ili
English: Keeping uric acid levels low by taking ADENURIC once every day stops crystals building up, and over time it reduces symptoms.
Croatian: Održavanjem niskih razina mokraćne kiseline uzimanjem ADENURICA jednom dnevno sprječava se nakupljanje kristala urata, a simptomi se s vremenom smanjuju.
English: However, drug-drug and drug-disease interactions were not explored during this study.
Croatian: Međutim, u ovom ispitivanju nisu istraživane interakcije lijek-lijek i lijek-bolest.
English: Population pharmacokinetic/pharmacodynamic analyses were conducted in 211 patients with hyperuricaemia and gout, treated with ADENURIC 40-240 mg QD.
Croatian: Farmakokinetičke/farmakodinamičke analize provedene su na populaciji od 211 bolesnika s hiperuricemijom i gihtom, liječenih ADENURICOM 40-240 mg jednom dnevno.
English: ADENURIC film-coated tablets are pale yellow to yellow in colour and capsule shaped.
Croatian: ADENURIC filmom obložene tablete su blijedožute do žute boje u obliku kapsule.
English: The mean serum uric acid levels over time for each treatment group from the two pivotal Phase 3 studies are shown in Figure 1.
Croatian: Prosječne vrijednosti razine mokraćne kiseline u serumu tijekom vremena za svaku skupinu liječenja u dva pivotalna ispitivanja faze 3 prikazane su na slici 1.
English: It is not known if ADENURIC may pass into human breast milk.
Croatian: Nije poznato može li ADENURIC prijeći u majčino mlijeko.
English: • decreased appetite, change in blood sugar levels (diabetes) of which a symptom may be excessive thirst, increased blood fat levels, weight increase
Croatian: • smanjen apetit, promjene razine šećera u krvi (dijabetes), simptom kojeg može biti jaka žeđ, povišene masnoće u krvi, porast tjelesne težine
English: No dose adjustment is required in the elderly (see section 5.2).
Croatian: Nije potrebno prilagođavanje doze kod starijih osoba (vidjeti dio 5.2).
English: ADENURIC should be taken by mouth and can be taken with or without food.
Croatian: ADENURIC treba uzimati na usta i može se uzimati s hranom ili bez nje.
English: Patheon France 40 Boulevard de Champaret FR-38300 Bourgoin Jallieu France or
Croatian: Patheon France 40 Boulevard de Champaret FR-38300 Bourgoin Jallieu Francuska ili
English: There were no significant changes observed in AUC of febuxostat or its metabolites following multiple oral doses of ADENURIC in elderly as compared to younger healthy subjects.
Croatian: Nisu uočene značajne promjene AUC-a febuksostata ili njegovih metabolita nakon primjene višekratnih oralnih doza ADENURICA kod starijih bolesnika u odnosu na mlađe, zdrave ispitanike.
English: If you have developed Stevens-Johnson Syndrome with the use of febuxostat, you must not be restarted on ADENURIC at any time.
Croatian: Ako se tijekom primjene febuksostata razvio Stevens-Johnsonov sindrom, ne smijete više nikada započeti terapiju ADENURICOM.
English: ADENURIC tablets contain lactose (a type of sugar).
Croatian: ADENURIC tablete sadrže laktozu (vrstu šećera).
English: Also contains lactose (as monohydrate).
Croatian: Također sadrži laktozu (u obliku hidrata).
English: ADENURIC is indicated in adults.
Croatian: ADENURIC je indiciran kod odraslih.
English: ADENURIC works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks.
Croatian: ADENURIC djeluje dovoljno brzo da se ponovno mjerenje mokraćne kiseline u serumu može provesti nakon 2 tjedna.
English: There was high dose maternal toxicity accompanied by a reduction in weaning index and reduced development of offspring in rats at approximately 4.3 times human exposure.
Croatian: Postojala je maternalna toksičnost praćena smanjenim indeksom odbića i smanjenim razvojem mladunaca kod štakora kod doza oko 4,3 puta većih od izloženosti kod ljudi.
English: If you are having a gout attack at the moment (a sudden onset of severe pain, tenderness, redness, warmth and swelling in a joint), wait for the gout attack to subside before first starting treatment with ADENURIC.
Croatian: Ako trenutačno imate napad gihta (nagla pojava jake boli, osjetljivosti, crvenila, topline i otoka zgloba), pričekajte da se napad gihta smiri prije nego što počnete liječenje ADENURICOM.
English: Film-coated tablet (tablets).
Croatian: Filmom obložena tableta (tablete).
English: In each phase 3 pivotal study, ADENURIC demonstrated superior ability to lower and maintain serum uric acid levels compared to allopurinol.
Croatian: U svakom pivotalnom ispitivanju faze 3, ADENURIC je pokazao superiornu sposobnost snižavanja i održavanja razina mokraćne kiseline u serumu u usporedbi s alopurinolom.
English: ADENURIC 80 mg and 120 mg is packed in clear (Aclar/PVC/Aluminium or PVC/PE/PVDC/Aluminium) blister of 14 tablets.
Croatian: ADENURIC 80 mg i 120 mg su pakirani u prozirni (Aclar/PVC/Aluminij ili PVC/PE/PVDC/Aluminij) blister od 14 tableta.
English: Incidence of overall treatment-emergent signs and symptoms and adverse drug reactions was 67.6% vs 64.7% and 6.4% vs 6.4% with ADENURIC and allopurinol respectively.
Croatian: Incidencija svih znakova i simptoma te nuspojava opaženih nakon početka liječenja bila je 67,6% naspram 64,7% i 6,4% naspram 6,4% na ADENURICU odnosno na alopurinolu.
English: The ability of ADENURIC to lower serum uric acid levels was prompt and persistent.
Croatian: Sposobnost ADENURICA da snizi razinu mokraćne kiseline u serumu bila je brza i trajna.
English: In the additional phase 3 CONFIRMS study, for which results became available after the marketing authorisation for ADENURIC was first issued, the primary efficacy endpoint was the proportion of patients whose serum urate level was < 6.0 mg/dL at the final visit.
Croatian: U dodatnom ispitivanju faze 3, CONFIRMS, za koje su rezultati postali dostupni nakon odobrenja za stavljanje ADENURICA u promet, primarni ishod ispitivanja bio je omjer bolesnika kod kojih je na zadnjoj kontroli razina urata u serumu bila < 6,0 mg/dl.
English: After single or multiple oral 80 and 120 mg once daily doses, Cmax is approximately 2.8-3.2 µg/mL, and 5.0-5.3 µg/mL, respectively.
Croatian: Nakon jednokratne ili višekratne doze od 80 i 120 mg primijenjene peroralno jednom dnevno Cmax je oko 2,8-3,2 µg/ml, odnosno 5,0-5,3 µg/ml.
English: Berlin-Chemie AG Tel: +49 (0) 30 67070
Croatian: Deutschland Berlin-Chemie AG Tel: +49 (0) 30 67070
English: Clear (Aclar/PVC/Aluminium or PVC/PE/PVDC/Aluminium) blister of 14 tablets.
Croatian: Prozirni (Aclar/PVC/Aluminij ili PVC/PE/PVDC/Aluminij) blister sa 14 tableta.