FrancophonIA/ELRC3.0 huggingface dataset:
English: Synjardy 5 mg/1,000 mg film-coated tablets Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Croatian: Synjardy 5 mg/1000 mg filmom obložene tablete Svaka tableta sadrži 5 mg empagliflozina i 1000 mg metforminklorida.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 12.5 mg/850 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VIŠESTRUKA PAKIRANJA - SREDNJA KUTIJA BEZ PLAVOG OKVIRA - 12,5 mg/850 mg
English: Synjardy 12.5 mg/1,000 mg film-coated tablets EU/1/15/1003/028
Croatian: Synjardy 12,5 mg/1000 mg filmom obložene tablete EU/1/15/1003/028
English: • stomach ache (abdominal pain)
Croatian: • bol u trbuhu (bol u abdomenu)
English: Synjardy 12.5 mg/850 mg film-coated tablets EU/1/15/1003/019
Croatian: Synjardy 12,5 mg/850 mg filmom obložene tablete EU/1/15/1003/019
English: PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 2 packs, each containing 60 x 1 film-coated tablets.
Croatian: Višestruko pakiranje koje sadrži 2 pakiranja, svako sa 60 x 1 filmom obloženom tabletom.
English: Synjardy 12.5 mg/850 mg film-coated tablets Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Croatian: Synjardy 12,5 mg/850 mg filmom obložene tablete Svaka tableta sadrži 12,5 mg empagliflozina i 850 mg metforminklorida.
English: Yellowish white, oval, biconvex film coated tablets debossed with “S5” and the Boehringer Ingelheim logo on one side and “850” on the other side (tablet length: 19.2 mm, tablet width: 9.4 mm).
Croatian: Žućkasto bijele, ovalne, bikonveksne filmom obložene tablete s oznakom „S5“ i logom Boehringer Ingelheim utisnutima na jednoj te oznakom „850“ na drugoj strani (duljina tablete: 19,2 mm, širina tablete: 9,4 mm).
English: Brownish yellow, oval, biconvex film coated tablets debossed with “S5” and the Boehringer Ingelheim logo on one side and “1000” on the other side (tablet length: 21.1 mm, tablet width: 9.7 mm).
Croatian: Smećkasto žute, ovalne, bikonveksne filmom obložene tablete s oznakom „S5“ i logom Boehringer Ingelheim utisnutima na jednoj te oznakom „1000“ na drugoj strani (duljina tablete: 21,1 mm, širina tablete: 9,7 mm).
English: Inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole) may decrease the renal elimination of metformin and thus lead to an increase in metformin plasma concentration.
Croatian: • inhibitorima OCT2 (kao što su cimetidin, dolutegravir, ranolazin, trimetoprim, vandetanib,
English: Pinkish white, oval, biconvex film coated tablets debossed with “S12” and the Boehringer Ingelheim logo on one side and “850” on the other side (tablet length: 19.2 mm, tablet width: 9.4 mm).
Croatian: Roskasto bijele, ovalne, bikonveksne filmom obložene tablete s oznakom „S12“ i logom Boehringer Ingelheim utisnutima na jednoj te oznakom „850“ na drugoj strani (duljina tablete: 19,2 mm, širina tablete: 9,4 mm).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka tableta sadrži 12,5 mg empagliflozina i 850 mg metforminklorida.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka tableta sadrži 5 mg empagliflozina i 850 mg metforminklorida.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX12.5 mg/1,000 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VANJSKOM OMOTU VIŠESTRUKOG PAKIRANJA - UKLJUČUJUĆI PLAVI OKVIR - 12,5 mg/1000 mg
English: Synjardy 12.5 mg/1,000 mg film-coated tablets are dark brownish purple, oval, biconvex.
Croatian: Synjardy 12,5 mg/1000 mg filmom obložene tablete su tamnosmećkasto ljubičaste, ovalne, bikonveksne.
English: Synjardy 12.5 mg/850 mg film-coated tablets and Synjardy 12.5 mg/1,000 mg film-coated tablets Tablet core
Croatian: Synjardy 12,5 mg/850 mg filmom obložene tablete i Synjardy 12,5 mg/1000 mg filmom obložene tablete
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX12.5 mg/850 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VANJSKOM OMOTU VIŠESTRUKOG PAKIRANJA - UKLJUČUJUĆI PLAVI OKVIR - 12,5 mg/850 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX5 mg/1,000 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VANJSKOM OMOTU VIŠESTRUKOG PAKIRANJA - UKLJUČUJUĆI PLAVI OKVIR - 5 mg/1000 mg
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka tableta sadrži 12,5 mg empagliflozina i 1000 mg metforminklorida.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX5 mg/850 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VANJSKOM OMOTU VIŠESTRUKOG PAKIRANJA - UKLJUČUJUĆI PLAVI OKVIR - 5 mg/850 mg
English: Each Synjardy 5 mg/1,000 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Croatian: Svaka Synjardy 5 mg/1000 mg filmom obložena tableta (tableta) sadrži 5 mg empagliflozina i 1000 mg metforminklorida.
English: Each Synjardy 12.5 mg/1,000 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Croatian: Svaka Synjardy 12,5 mg/1000 mg filmom obložena tableta (tableta) sadrži 12,5 mg empagliflozina i 1000 mg metforminklorida.
English: Each Synjardy 12.5 mg/850 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Croatian: Svaka Synjardy 12,5 mg/850 mg filmom obložena tableta (tableta) sadrži 12,5 mg empagliflozina i 850 mg metforminklorida.
English: HbA1c (%) Baseline (mean) Change from baseline Comparison vs. empa (95% CI)
Croatian: Promjena od početne vrijednosti Usporedba naspram empa (95 % CI)
English: • a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years),
Croatian: • značajno smanjenje apsolutnog rizika od bilo koje komplikacije povezane s šećernom bolešću u skupini liječenoj metforminom (29,8 događaja/1 000 bolesnik-godina) naspram samo režima prehrane (43,3 događaja/1 000 bolesnik-godina), p= 0,0023 te naspram skupina liječenih kombinacijom sa sulfonilurejom i inzulinom u monoterapiji (40,1 događaja/1 000 bolesnikgodina), p= 0,0034,
English: Synjardy 12.5 mg/1,000 mg film-coated tablets Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Croatian: Synjardy 12,5 mg/1000 mg filmom obložene tablete Svaka tableta sadrži 12,5 mg empagliflozina i 1000 mg metforminklorida.
English: SBP (mmHg) Baseline (mean) Change from baseline Difference from placebo (95% CI) Mean adjusted for baseline value Not evaluated for statistical significance; not part of sequential testing procedure for the secondary endpoints MMRM model on FAS (OC) included baseline HbA1c, baseline eGFR (MDRD), geographical region, visit, treatment, and treatment by visit interaction.
Croatian: Promjena od početne vrijednosti Razlika od placeba (95% CI) Srednja vrijednost prilagođena za početnu vrijednost Statistička značajnost nije ocjenjivana; nije dio naknadnog testnog postupka za sekundarne mjere ishoda Modeli miješanih učinaka za ponovljena mjerenja (MMRM model od engl. mixed effects models for repeated measurements) na potpunom skupu za analizu (engl.
English: Temporary interruption of treatment should be considered in patients with complicated urinary tract infections.
Croatian: U bolesnika s kompliciranim infekcijama mokraćnog sustava potrebno je razmotriti privremeni prekid liječenja.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka tableta sadrži 5 mg empagliflozina i 1000 mg metforminklorida.
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/1,000 mg tablets empagliflozin/metformin HCL
Croatian: NAZIV LIJEKA Synjardy 5 mg/1000 mg tablete empagliflozin/metforminklorid
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/850 mg tablets empagliflozin/metformin HCL
Croatian: NAZIV LIJEKA Synjardy 12,5 mg/850 mg tablete empagliflozin/metforminklorid
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/1,000 mg tablets empagliflozin/metformin HCL
Croatian: NAZIV LIJEKA Synjardy 12,5 mg/1000 mg tablete empagliflozin/metforminklorid
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: Transporteri organskih kationa (OCT)
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/850 mg tablets empagliflozin/metformin HCL
Croatian: NAZIV LIJEKA Synjardy 5 mg/850 mg tablete empagliflozin/metforminklorid
English: Dark brownish purple, oval, biconvex film coated tablets debossed with “S12” and the Boehringer Ingelheim logo on one side and “1000” on the other side (tablet length: 21.1 mm, tablet width: 9.7 mm).
Croatian: Tamnosmećkasto ljubičaste, ovalne, bikonveksne filmom obložene tablete s oznakom „S12“ i logom Boehringer Ingelheim utisnutima na jednoj te oznakom „1000“ na drugoj strani (duljina tablete: 21,1 mm, širina tablete: 9,7 mm).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 12.5 mg/1,000 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VIŠESTRUKA PAKIRANJA - SREDNJA KUTIJA BEZ PLAVOG OKVIRA12,5 mg/1000 mg
English: Placebo empagliflozin
Croatian: Učinci drugih lijekova na empagliflozin
English: Identified adverse reactions of empagliflozin monotherapy Identified adverse reactions of metformin monotherapy
Croatian: Identificirane nuspojave monoterapije metforminom
English: Do not take Synjardy if you are breast-feeding.
Croatian: Ne uzimajte Synjardy ako dojite.
English: Urinary tract infection
Croatian: Infekcije mokraćnog sustava
English: Fertility
Croatian: Nefropatija
English: EU/1/15/1003/001 10 film-coated tablets EU/1/15/1003/002 14 film-coated tablets EU/1/15/1003/003 30 film-coated tablets EU/1/15/1003/004 56 film-coated tablets EU/1/15/1003/005 60 film-coated tablets EU/1/15/1003/037 90 film-coated tablets EU/1/15/1003/006 100 film-coated tablets
Croatian: EU/1/15/1003/001 10 filmom obloženih tableta EU/1/15/1003/002 14 filmom obloženih tableta EU/1/15/1003/003 30 filmom obloženih tableta EU/1/15/1003/004 56 filmom obloženih tableta EU/1/15/1003/005 60 filmom obloženih tableta EU/1/15/1003/037 90 filmom obloženih tableta EU/1/15/1003/006 100 filmom obloženih tableta
English: EU/1/15/1003/019 10 film-coated tablets EU/1/15/1003/020 14 film-coated tablets EU/1/15/1003/021 30 film-coated tablets EU/1/15/1003/022 56 film-coated tablets EU/1/15/1003/023 60 film-coated tablets EU/1/15/1003/039 90 film-coated tablets EU/1/15/1003/024 100 film-coated tablets
Croatian: EU/1/15/1003/019 10 filmom obloženih tableta EU/1/15/1003/020 14 filmom obloženih tableta EU/1/15/1003/021 30 filmom obloženih tableta EU/1/15/1003/022 56 filmom obloženih tableta EU/1/15/1003/023 60 filmom obloženih tableta EU/1/15/1003/039 90 filmom obloženih tableta EU/1/15/1003/024 100 filmom obloženih tableta
English: What Synjardy looks like and contents of the pack Synjardy 5 mg/850 mg film-coated tablets are yellowish white, oval, biconvex.
Croatian: Synjardy 5 mg/850 mg filmom obložene tablete su žućkasto bijele, ovalne, bikonveksne.
English: EU/1/15/1003/028 10 film-coated tablets EU/1/15/1003/029 14 film-coated tablets EU/1/15/1003/030 30 film-coated tablets EU/1/15/1003/031 56 film-coated tablets EU/1/15/1003/032 60 film-coated tablets EU/1/15/1003/040 90 film-coated tablets EU/1/15/1003/033 100 film-coated tablets
Croatian: EU/1/15/1003/028 10 filmom obloženih tableta EU/1/15/1003/029 14 filmom obloženih tableta EU/1/15/1003/030 30 filmom obloženih tableta EU/1/15/1003/031 56 filmom obloženih tableta EU/1/15/1003/032 60 filmom obloženih tableta EU/1/15/1003/040 90 filmom obloženih tableta EU/1/15/1003/033 100 filmom obloženih tableta
English: Body mass index had no clinically relevant effect on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Croatian: Na osnovi farmakokinetičke analize populacije, indeks tjelesne mase (ITM) nije imao klinički značajan učinak na farmakokinetiku empagliflozina.
English: EU/1/15/1003/010 10 film-coated tablets EU/1/15/1003/011 14 film-coated tablets EU/1/15/1003/012 30 film-coated tablets EU/1/15/1003/013 56 film-coated tablets EU/1/15/1003/014 60 film-coated tablets EU/1/15/1003/038 90 film-coated tablets EU/1/15/1003/015 100 film-coated tablets
Croatian: EU/1/15/1003/010 10 filmom obloženih tableta EU/1/15/1003/011 14 filmom obloženih tableta EU/1/15/1003/012 30 filmom obloženih tableta EU/1/15/1003/013 56 filmom obloženih tableta EU/1/15/1003/014 60 filmom obloženih tableta EU/1/15/1003/038 90 filmom obloženih tableta EU/1/15/1003/015 100 filmom obloženih tableta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/034 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/035 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/036 200 (2 x 100 x 1) film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1003/034 120 (2 x 60 x 1) filmom obloženih tableta EU/1/15/1003/035 180 (2 x 90 x 1) filmom obloženih tableta EU/1/15/1003/036 200 (2 x 100 x 1) filmom obloženih tableta
English: Erythema
Croatian: • svrbež
English: No data are available.
Croatian: OUTCOME bila ograničena.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/025 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/026 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/027 200 (2 x 100 x 1) film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1003/025 120 (2 x 60 x 1) filmom obloženih tableta EU/1/15/1003/026 180 (2 x 90 x 1) filmom obloženih tableta EU/1/15/1003/027 200 (2 x 100 x 1) filmom obloženih tableta
English: Posology
Croatian: OUTCOME
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/016 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/017 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/018 200 (2 x 100 x 1) film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1003/016 120 (2 x 60 x 1) filmom obloženih tableta EU/1/15/1003/017 180 (2 x 90 x 1) filmom obloženih tableta EU/1/15/1003/018 200 (2 x 100 x 1) filmom obloženih tableta
English: Eli Lilly Italia S.p.A. Tel: +39 055 42571
Croatian: Tel: +39 055 42571
English: • muscle cramps
Croatian: • grčevi u mišićima
English: b, 2
Croatian: Tablica 2:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/007 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/008180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/009 200 (2 x 100 x 1) film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1003/007 120 (2 x 60 x 1) filmom obloženih tableta EU/1/15/1003/008 180 (2 x 90 x 1) filmom obloženih tableta EU/1/15/1003/009 200 (2 x 100 x 1) filmom obloženih tableta
English: Hepatic injury
Croatian: Oštećenje bubrega
English: Surgery
Croatian: Dizurija
English: 90 (3 x 30) tablets (multipack)
Croatian: 90 (3 x 30) tableta (multipakiranje)
English: Pack size
Croatian: (Zaštićeno) ime
English: The doctor should check the response every four to six weeks and adjust the dose if needed.
Croatian: Liječnik treba provjeriti odgovor svakih četiri do šest tjedana i prilagoditi dozu ako je potrebno.
English: The maximum dose is 30 mg per day.
Croatian: Maksimalna doza je 30 mg na dan.
English: The majority of side effects were mild to moderate and of limited duration.
Croatian: Većina nuspojava bila je blaga do umjerena i ograničenog trajanja.
English: Growth hormone promotes growth during childhood and adolescence.
Croatian: Hormon rasta potiče rast tijekom djetinjstva i adolescencije.
English: IGF-I levels were normal at the end of the study (week 12) in 38.5%, 75% and 82% of patients treated with 10, 15 or 20 mg/day Somavert, respectively, compared with 9.7% of the patients treated with placebo.
Croatian: Razine faktora rasta IGF-I bile su normalne na kraju ispitivanja (12. tjedan) u 28,5 %, 75,5 % i 82 % bolesnika koji su primali 10, 15 odnosno 20 mg/dan lijeka Somavert, u usporedbi s 9,7 % bolesnika koji su primali placebo.
English: The patient first receives a starting dose of 80 mg under medical supervision.
Croatian: Bolesnik prvo prima početnu dozu od 80 mg uz liječnički nadzor.
English: If levels are too high, the doctor may decide not to begin or to stop treatment with Somavert.
Croatian: Ako su razine previsoke, liječnik može odlučiti da neće započeti ili da će prekinuti liječenje lijekom Somavert.
English: The most common side effects of Somavert (seen in more than 1 in 10 people) were headache, diarrhoea and joint pain.
Croatian: Najčešće nuspojave lijeka Somavert (koje se mogu javiti u više od 1 na 10 osoba) bile su glavobolja, proljev i bol u zglobovima.
English: The effectiveness was measured by comparing the levels of insulin-like growth factor-I (IGF-I) before and at the end of the study.
Croatian: Učinkovitost je mjerena uspoređivanjem razina inzulinu sličnog faktora rasta-I (IGF-I) prije ispitivanja te na njegovu završetku.
English: What measures are being taken to ensure the safe and effective use of Somavert?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Somavert?
English: Following this, Somavert is given as an injection of 10 mg once a day.
Croatian: Nakon toga, lijek Somavert daje se jednom na dan u obliku injekcije od 10 mg.
English: IGF-I is regulated by human growth hormone and causes growth in the body.
Croatian: IGF-I je reguliran ljudskim hormonom rasta te uzrokuje rast u tijelu.
English: Further information on Somavert can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Somavert.
Croatian: Lijek Somavert dobio je odobrenje za stavljanje u promet koje je na snazi u EU-a od 13. studenoga 2002. Više informacija o lijeku Somavert nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Somavert.
English: Side effects reported with Somavert are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Somavert pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Other information about Somavert
Croatian: Ostale informacije o lijeku Somavert
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Somavert have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Somavert nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Afterwards, they received 10, 15 or 20 mg Somavert per day or placebo.
Croatian: Nakon toga primali su 10, 15 ili 20 mg lijeka Somavert jednom dnevno ili placebo.
English: Before starting and during treatment with Somavert, the patient should have tests to measure levels of liver enzymes in the blood.
Croatian: Prije početka liječenja i tijekom liječenja lijekom Somavert bolesnik bi trebao napraviti pretrage kako bi se izmjerile razine jetrenih enzima u krvi.
English: Patients received a starting dose of 80 mg Somavert or placebo (a dummy treatment).
Croatian: Bolesnici su primili početnu dozu od 80 mg lijeka Somavert ili placebo (prividno liječenje).
English: Somavert has been studied in 112 patients with acromegaly in a 12-week study.
Croatian: Lijek Somavert ispitivan je u 112 bolesnika s akromegalijom u ispitivanju koje je trajalo 12 tjedana.
English: As for all medicines, data on the use of Somavert are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Somavert kontinuirano se prate.
English: What is Somavert and what is it used for?
Croatian: Što je Somavert i za što se primjenjuje?
English: Why is Somavert authorised in the EU?
Croatian: Zašto je Somavert odobren u EU-u?
English: The European Medicines Agency decided that Somavert's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Somavert nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Somavert is used in patients who did not respond well to surgery and/or radiation therapy, and to treatment with somatostatin analogues (another type of medicine used in acromegaly).
Croatian: Lijek Somavert se primjenjuje u bolesnika koji nisu imali odgovarajući odgovor na kirurško liječenje i/ili na terapiju zračenjem te na liječenje analozima somatostatina (druga vrsta lijeka protiv akromegalije).
English: What are the risks associated with Somavert?
Croatian: Koji su rizici povezani s lijekom Somavert?
English: Somavert can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of acromegaly.
Croatian: Somavert se izdaje samo na recept, a liječenje mora započeti liječnik s iskustvom u liječenju akromegalije.
English: An overview of Somavert and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Somavert i zašto je odobren u EU-u
English: The patient or caregiver can inject Somavert after being trained by a doctor or a nurse.
Croatian: Somavert mogu ubrizgati bolesnik ili pružatelj skrbi nakon što su ih za to obučili liječnik ili medicinska sestra.
English: Somavert lowered IGF-I levels at all of the doses tested.
Croatian: Lijek Somavert snizio je razine faktora IGF-I pri svim ispitivanim dozama.
English: Somavert is a medicine used to treat adults with acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults and is caused by the pituitary gland producing excess growth hormone.
Croatian: Somavert je lijek koji se primjenjuje za liječenje odraslih bolesnika s akromegalijom, rijetkim hormonskim poremećajem koji obično nastaje u odraslih osoba srednjih godina, a uzrokuje ga hipofiza koja pojačano luči hormon rasta.
English: By blocking the receptors, Somavert prevents growth hormone from having an effect, thereby preventing the unwanted growth and other disorders seen in acromegaly.
Croatian: Inhibiranjem receptora Somavert sprečava djelovanje hormona rasta, čime se sprečavaju neželjen rast i ostali poremećaji povezani s akromegalijom.
English: Somavert contains the active substance pegvisomant.
Croatian: Lijek Somavert sadržava djelatnu tvar pegvisomant.
English: For more information about using Somavert, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Somavert pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The active substance in Somavert, pegvisomant, is very similar to human growth hormone, but it has been designed so that it blocks the receptors to which growth hormone normally attaches itself.
Croatian: Djelatna tvar lijeka Somavert, pegvisomant, vrlo je slična ljudskom hormonu rasta, no dizajnirana je tako da inhibira receptore na koje se normalno vezuje hormon rasta.
English: Acromegaly occurs when the pituitary gland at the base of the brain makes too much growth hormone, generally because of a benign (non-cancerous) tumour.
Croatian: Akromegalija nastaje kada hipofiza u donjem dijelu mozga proizvodi prekomjerne razine hormona rasta, najčešće zbog dobroćudnog (nekanceroznog) tumora.
English: Somavert is available as powder and solvent that are mixed together to make up a solution for injection under the skin.
Croatian: Lijek Somavert dostupan je u obliku praška i otapala koji se izmiješaju da bi se pripremila otopina za potkožnu injekciju.
English: What benefits of Somavert have been shown in studies?
Croatian: Koje su koristi od lijeka Somavert utvrđene u ispitivanjima?
English: How does Somavert work?
Croatian: Kako djeluje Somavert?