FrancophonIA/ELRC3.0 huggingface dataset:
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor antagonists, including telmisartan.
Croatian: Tijekom istovremene primjene litija s inhibitorima enzima angiotenzin-konvertaze i s antagonistima receptora angiotenzina II, uključujući telmisartan, prijavljena su reverzibilna povećanja koncentracije litija u serumu i toksičnost.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim (Logo)
Croatian: Boehringer Ingelheim (logo)
English: Mood changes, impaired vision, ringing in the ears, shortness of breath, sneezing/running nose, change of bowel habit, hair loss, unusual bruising and bleeding (red blood cell damage), skin discolouration, increased sweating, difficulty passing urine, increased need to pass urine especially at night, enlarging of male breasts, pain, weight increased, weight decreased.
Croatian: Promjene raspoloženja, oštećeni vid, šum u ušima, nedostatak zraka, kihanje/curenje nosa, promjenaučestalosti stolice, gubitak kose, neuobičajene modrice i krvarenje (oštećenje crvenih krvnih stanica), promjena boje kože, pojačano znojenje, otežano mokrenje, povećana potreba za mokrenjem osobito noću, povećanje dojki u muškaraca, bolovi, porast težine, smanjenje težine.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/10 mg
Croatian: BLISTER DJELJIV NA JEDINIČNE DOZE SA 10 TABLETA - 80 mg/10 mg
English: The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5).
Croatian: Istodobna primjena telmisartana s aliskirenom je kontraindicirana kod bolesnika s dijabetes melitusom ili oštećenjem bubrega (GFR < 60 ml/min/1,73 m2) (vidjeti dijelove 4.2, 4.4, 4.5).
English: Onduarp 40 mg/5 mg tablets may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg alone.
Croatian: Onduarp 40 mg/5 mg tablete mogu primjenjivati bolesnici kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka monoterapijom amlodipina 5 mg.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) The combination of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) and is not recommended in other patients (see sections
Croatian: Dvostruka blokada sustava renin-angiotenzin-aldosteron (RAAS) Kombinacija telmisartana s aliskirenom je kontraindicirana kod bolesnika s dijabetes melitusom ili oštećenjem bubrega (GFR < 60 ml/min/1,73 m2) te se ne preporučuje kod drugih bolesnika (vidjeti dijelove 4.3, 4.4).
English: Concomitant use of telmisartan with aliskiren is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Croatian: Istodobna primjena telmisartana s aliskirenom je kontraindicirana kod bolesnika s oštećenjem bubrega (GFR < 60 ml/min/1,73 m2) (vidjeti dio 4.3).
English: INFORMATION IN BRAILLE Onduarp 40 mg/10 mg
Croatian: Onduarp 40 mg/10 mg
English: INFORMATION IN BRAILLE Onduarp 40 mg/5 mg
Croatian: Onduarp 40 mg/5 mg
English: INFORMATION IN BRAILLE Onduarp 80 mg/5 mg
Croatian: Onduarp 80 mg/5 mg
English: Cardiac disorders Rare:
Croatian: Poremećaji srca Rijetko:
English: INFORMATION IN BRAILLE Onduarp 80 mg/10 mg
Croatian: Onduarp 80 mg/10 mg
English: Cardiac disorders Very rare:
Croatian: Poremećaji srca Vrlo rijetko:
English: Urinary bladder infection, feeling sad (depression), feeling anxious, sleeplessness, fainting, nerve damage in the hands or feet, reduced sense of touch, taste abnormalities, trembling, vomiting, enlarged gums, discomfort in the abdomen, dry mouth, eczema (a skin disorder), redness of skin, rash, back pain, leg pain, urge to urinate during the night, feeling unwell (malaise), increased levels of uric acid in the blood.
Croatian: Infekcija mokraćnog mjehura, osjećaj tuge (depresija), osjećaj tjeskobe, pospanost, nesvjestica, oštećenje živca u rukama ili stopalima, smanjen osjet dodira, poremećaj okusa, drhtanje, povraćanje, povećane desni, neugoda u trbuhu, suhoća usta, egzem (poremećaj kože), crvenilo kože, osip, bol u leđima, bol u nogama, žurna potreba mokrenja tijekom noći, opće loše osjećanje (malaksalost), povišene vrijednosti mokraćne kiseline u krvi.
English: Onduarp 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg.
Croatian: Onduarp 40 mg/10 mg tablete mogu primjenjivati bolesnici kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka monoterapijom amlodipina 10 mg.
English: Dual blockade of the renin-angiotensin-aldosterone system The use of telmisartan in combination with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Croatian: Dvostruka blokada sustava renin-angiotenzin-aldosteron Primjena telmisartana u kombinaciji s aliskirenom je kontraindicirana kod bolesnika s dijabetes melitusom ili oštećenjem bubrega (GFR < 60 ml/min/1,73 m2) (vidjeti dio 4.3).
English: Meglumine
Croatian: Dispneja
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/10 mg tablets
Croatian: Onduarp 80 mg/10 mg tablete
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/5 mg tablets
Croatian: Onduarp 80 mg/5 mg tablete
English: NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/5 mg tablets
Croatian: Onduarp 40 mg/5 mg tablete
English: NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/10 mg tablets
Croatian: Onduarp 40 mg/10 mg tablete
English: Change of bowel habit Pancreatitis, gastritis
Croatian: Pankreatitis, gastritis
English: MARKETING AUTHORISATION NUMBERS EU/1/11/729/005 (28 tablets) EU/1/11/729/006 (36 (4 x 90 x 1) tablets)
Croatian: EU/1/11/729/005 (28 tableta) EU/1/11/729/006 (36 (4 x 90 x 1) tableta)
English: Replacement therapy
Croatian: Zamjenska terapija
English: MARKETING AUTHORISATION NUMBERS EU/1/11/729/003 (28 tablets) EU/1/11/729/004 (360 (4 x 90 x 1) tablets)
Croatian: EU/1/11/729/003 (28 tableta) EU/1/11/729/004 (360 (4 x 90 x 1) tableta)
English: Uncommon side effects (may affect up to 1 in 100 people):
Croatian: Manje česte nuspojave (mogu pogoditi do 1 na 100 osoba):
English: General disorders and administration site conditions peripheral oedema asthenia, chest pain, fatigue, oedema malaise
Croatian: Opći poremećaji i poremećaji mjesta primjene periferni edem astenija, bol u prsištu, umor, edem malaksalost
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/5 mg
Croatian: BLISTER DJELJIV NA JEDINIČNE OD 10 TABLETA - 80 mg/5 mg
English: Onduarp showed dose-related reductions in systolic/diastolic blood pressure across the therapeutic dose range of −21.8/−16.5 mmHg (40 mg/5 mg), −22.1/−18.2 mmHg (80 mg/5 mg),
Croatian: Onduarp je, ovisno o rasponu doza, pokazala sniženje sistoličkog/dijastoličkog krvnog tlaka od -21,8/16,5 mmHg (40 mg/5 mg), -22,1/-18,2 mmHg (80 mg/5 mg), -24,7/-20,2 mmHg (40 mg/10 mg) i26,4/-20,1 mmHg (80 mg/10 mg).
English: After 8 weeks of treatment, each of the combination treatments was statistically significantly superior to amlodipine monotherapy in reducing diastolic and systolic blood pressure (−11.1/−9.2 mmHg, −11.3/ −9.3 mmHg with 40 mg/10 mg, 80 mg/10 mg versus −7.4/−6.5 mmHg with amlodipine 10 mg) and higher diastolic blood pressure normalisation rates compared to monotherapy were achieved (63.7 %, 66.5 % with 40 mg/10 mg, 80 mg/10 mg versus 51.1 % with amlodipine 10 mg).
Croatian: Nakon 8 tjedana liječenja, svaka od kombinacija bila je statistički superiorna u odnosu na obje monoterapijske doze amlodipina u snižavanju sistoličkog i dijastoličkog krvnog tlaka (-13,6/-9,4 mmHg, -15,0/-10,6 mmHg uz 40 mg/5 mg, 80 mg/5 mg u odnosu na -6,2/5,7 mmHg, -11,1/-8,0 mmHg uz amlodipin 5 mg i 10 mg, a postignuta je viša stopa kontrole dijastoličkog krvnog tlaka u usporedbi s relevantnim monoterapijama (56,7%, 63,8% uz 40 mg/5 mg i 80 mg/5 mg u odnosu na 42%, 56,7% uz amlodipin 5 mg i 10 mg).
English: Onduarp 80 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled on Onduarp 40 mg/10 mg or Onduarp 80 mg/5 mg.
Croatian: Onduarp 80 mg/10 mg tablete mogu primjenjivati bolesnici kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka s Onduarpom 40 mg/10 mg.
English: The observed mean changes in systolic/diastolic blood pressure with a combination therapy containing amlodipine 5 mg (−22.2/−17.2 mmHg with 40 mg/5 mg; −22.5/−19.1 mmHg with 80 mg/5 mg) were comparable to or greater than those seen with amlodipine 10 mg (−21.0/−17.6 mmHg) and associated with significant lower oedema rates (1.4 % with 40 mg/5 mg; 0.5 % with 80 mg/5 mg; 17.6 % with amlodipine 10 mg).
Croatian: Primijećene prosječne promjene sistoličkog/dijastoličkog krvnog tlaka uz kombiniranu terapiju s amlodipinom 5 mg (-22,2/17,2 mmHg s 40 mg/5 mg; -22,5/-19,1 mmHg uz 80 mg/5 mg) bile su usporedive ili veće od onih primijećenih uz amolodipin 10 mg (-21,0/-17,6 mmHg) te povezane sa značajno nižom učestalošću edema (1,4% uz 40 mg/5 mg; 0,5% uz 80mg/5 mg; 17,6% uz amlodipin 10 mg).
English: The observed mean changes in systolic/diastolic blood pressure with a combination therapy containing amlodipine 5 mg (−22.2/−17.2 mmHg with 40 mg/5 mg; −22.5/−19.1 mmHg with 80 mg/5 mg) were comparable to or greater than those seen with amlodipine 10 mg (−21.0/−17.6 mmHg) and associated with significant lower oedema rates (1.4% with 40 mg/5 mg; 0.5 % with 80 mg/5 mg; 17.6 % with amlodipine 10 mg).
Croatian: Primijećene prosječne promjene sistoličkog/dijastoličkog krvnog tlaka uz kombiniranu terapiju s amlodipinom 5 mg (-22,2/17,2 mmHg s 40 mg/5 mg; -22,5/-19,1 mmHg uz 80 mg/5 mg) bile su usporedive ili veće od onih primijećenih uz amolodipin 10 mg (-21,0/-17,6 mmHg) te povezane sa značajno nižim stopama edema (1,4% uz 40 mg/5 mg; 0,5% uz 80mg/5 mg; 17,6% uz amlodipin 10 mg).
English: Anaemia Thrombocytopenia, eosinophilia
Croatian: Trombocitopenija, eozinofilija
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/5 mg
Croatian: BLISTER SA 7 TABLETA - 40 mg/5 mg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/10 mg
Croatian: BLISTER SA 7 TABLETA - 40 mg/10 mg
English: Hepatic impairment
Croatian: Teška hipotenzija
English: Package leaflet: Information for the user Onduarp 40 mg/10 mg tablets Telmisartan/Amlodipine
Croatian: Uputa o lijeku: Informacija za korisnika Onduarp 40 mg/10 mg tablete telmisartan/amlodipin
English: Batch
Croatian: Tahikardija
English: Package leaflet: Information for the user Onduarp 40 mg/5 mg tablets Telmisartan/Amlodipine
Croatian: Uputa o lijeku: Informacija za korisnika Onduarp 40 mg/5 mg tablete telmisartan/amlodipin
English: What Onduarp looks like and contents of the pack Onduarp 40 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the other side.
Croatian: Onduarp 40 mg/5 mg tablete su dvoslojne, plavo-bijele tablete ovalnog oblika, s utisnutom oznakom proizvoda A1 i logom tvrtke na drugoj strani.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 80 mg/10 mg
Croatian: UNUTARNJA KUTIJA VIŠESTRUKOG PAKOVANJA OD 360 (4 PAKOVANJA S 90 x 1 TABLETOM) - BEZ PLAVOG OKVIRA - 80 mg/10 mg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/5 mg
Croatian: BLISTER SA 7 TABLETA - 80 mg/5 mg
English: The main risk factors for hyperkalaemia to be considered are: - Diabetes mellitus, renal impairment, age (>70 years) - Combination with one or more other medicinal products that affect the renin-angiotensinaldosterone system and/or potassium supplements.
Croatian: Glavni rizični faktori za hiperkalijemiju koje je potrebno razmotriti su: - Dijabetes melitus, oštećenje bubrega, dob (>70 godina).
English: Renal impairment including acute renal failure General disorders and administration site conditions Rare:
Croatian: Opći poremećaji i reakcije na mjestu primjene Rijetko:
English: Package leaflet: Information for the user Onduarp 80 mg/10 mg tablets Telmisartan/Amlodipine
Croatian: Uputa o lijeku: Informacija za korisnika Onduarp 80 mg/10 mg tablete telmisartan/amlodipin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 80 mg/5 mg
Croatian: UNUTARNJA KUTIJA VIŠESTRUKOG PAKOVANJA OD 360 (4 PAKOVANJA S 90 x 1 TABLETOM) - BEZ PLAVOG OKVIRA - 80 mg/5 mg
English: Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as besylate).
Croatian: Svaka tableta sadržava 40 mg telmisartana i 5 mg amlodipina (u obliku amlodipinbesilata).
English: Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as besylate).
Croatian: Svaka tableta sadržava 80 mg telmisartana i 5 mg amlodipina (u obliku amlodipinbesilata).
English: Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as besylate).
Croatian: Svaka tableta sadržava 80 mg telmisartana i 10 mg amlodipina (u obliku amlodipinbesilata).
English: Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as besylate).
Croatian: Svaka tableta sadržava 40 mg telmisartana i 10 mg amlodipina (u obliku amlodipinbesilata).
English: Package leaflet: Information for the user Onduarp 80 mg/5 mg tablets Telmisartan/Amlodipine
Croatian: Uputa o lijeku: Informacija za korisnika Onduarp 80 mg/5 mg tablete telmisartan/amlodipin
English: MARKETING AUTHORISATION NUMBERS EU/1/11/729/001 (28 tablets)
Croatian: EU/1/11/729/001 (28 tableta)
English: What Onduarp looks like and contents of the pack Onduarp 80 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the other side.
Croatian: Onduarp 80 mg/10 mg tablete su dvoslojne, plavo-bijele tablete ovalnog oblika, s utisnutom oznakom proizvoda A4 i logom tvrtke na drugoj strani.
English: What Onduarp looks like and contents of the pack Onduarp 80 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the other side.
Croatian: Onduarp 80 mg/5 mg tablete su dvoslojne, plavo-bijele tablete ovalnog oblika, s utisnutom oznakom proizvoda A3 i logom tvrtke na drugoj strani.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 80 mg/10 mg
Croatian: VANJSKA NALJEPNICA NA VIŠESTRUKOM PAKOVANJU OD 360 (4 PAKOVANJA S 90 x 1 TABLETOM) - UKLJUČUJUĆI PLAVI OKVIR - 80 mg/10 mg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/10 mg
Croatian: BLISTER SA 7 TABLETA - 80 mg/10 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 80 mg/5 mg
Croatian: VANJSKA NALJEPNICA NA VIŠESTRUKOM PAKOVANJU OD 360 (4 PAKOVANJA S 90 x 1 TABLETOM) - UKLJUČUJUĆI PLAVI OKVIR - 80 mg/5 mg
English: NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/10 mg tablets telmisartan/amlodipine
Croatian: Onduarp 40 mg/10 mg tablete telmisartan/amlodipin
English: Blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the other side.
Croatian: Dvoslojna plavo-bijela tableta ovalnog oblika, s utisnutom oznakom proizvoda A1 i logom tvrtke na drugoj strani.
English: What Onduarp looks like and contents of the pack Onduarp 40 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the other side.
Croatian: Onduarp 40 mg/10 mg tablete su dvoslojne, plavo-bijele tablete ovalnog oblika, s utisnutom oznakom proizvoda A2 i logom tvrtke na drugoj strani.
English: MARKETING AUTHORISATION NUMBERS EU/1/11/729/002 (28 tablets)
Croatian: EU/1/11/729/002 (28 tableta)
English: Respiratory, thoracic and mediastinal disorders cough
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja kašalj
English: NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/5 mg tablets telmisartan/amlodipine
Croatian: Onduarp 40 mg/5 mg tablete telmisartan/amlodipin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/004 (360 (4 x 90 x 1) tablets)
Croatian: EU/1/11/729/004 (360 (4 x 90 x 1) tableta)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/006 (360 (4 x 90 x 1) tablets)
Croatian: EU/1/11/729/006 (360 (4 x 90 x 1) tableta)
English: Blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the other side.
Croatian: Dvoslojna plavo-bijela tableta ovalnog oblika, s utisnutom oznakom proizvoda A4 i logom tvrtke na drugoj strani.
English: Blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the other side.
Croatian: Dvoslojna plavo-bijela tableta ovalnog oblika, s utisnutom oznakom proizvoda A3 i logom tvrtke na drugoj strani.
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/10 mg tablets telmisartan/amlodipine
Croatian: Onduarp 80 mg/10 mg tablete telmisartan/amlodipin
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/5 mg tablets telmisartan/amlodipine
Croatian: Onduarp 80 mg/5 mg tablete telmisartan/amlodipin
English: Blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the other side.
Croatian: Dvoslojna plavo-bijela tableta ovalnog oblika, s utisnutom oznakom proizvoda A2 i logom tvrtke na drugoj strani.
English: Micturition disorder, pollakiuria Reproductive system and breast disorders Uncommon:
Croatian: Tahikardija Poremećaji dišnog sustava, prsišta i sredoprsja Manje često:
English: Check with your doctor or pharmacist if you are not sure.
Croatian: Ako niste sigurni, posavjetujte se s liječnikom ili ljekarnikom.
English: MARKETING AUTHORISATION HOLDER
Croatian: ODOBRENJA ZA STAVLJANJE GOTOVOG lIJEKA U PROMET
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/005 (28 tablets)
Croatian: EU/1/11/729/005 (28 tableta)
English: Hepatic function abnormal, liver disorder2 Skin and subcutaneous tissue disorders Uncommon: Rare:
Croatian: Angioedem (s fatalnim ishodom), medikamentni osip, toksične erupcije na koži, urtikarija Poremećaji mišićno-koštanog sustava i vezivnog tkiva Rijetko:
English: Vascular disorders Very rare:
Croatian: Poremaćaji srca Vrlo rijetko:
English: What is Raligize?
Croatian: Što je Raligize?
English: On 10 July 2018, FGK Representative Service GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Raligize, for the treatment of cancer of the cervix (the neck of the womb).
Croatian: Dana 10. srpnja 2018. tvrtka FGK Representative Service GmbH službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Raligize za liječenje karcinoma cerviksa (vrata maternice).
English: As the CAT was still evaluating the initial documentation provided by the company on behalf of the CHMP, it had not yet made any recommendations.
Croatian: Budući da je CAT još procjenjivao inicijalnu dokumentaciju koju je dostavila tvrtka u ime CHMP-a, CHMP još uvijek nije donio nikakve preporuke.
English: It was to be available as a concentrate for making up an infusion (drip) to be given into a vein.
Croatian: Trebao je biti dostupan kao koncentrat od kojeg se priprema infuzija (kapanje) u venu.
English: The application was withdrawn while the CAT was still evaluating the initial documentation provided by the company.
Croatian: Zahtjev je povučen u trenutku kada je CAT još procjenjivao inicijalnu dokumentaciju koju je tvrtka dostavila.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Raligize.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se primjenjuje lijek Raligize.
English: EMA/499771/2018
Croatian: (aksalimogen filolisbak) EMA/499771/2018
English: Raligize was developed as a type of advanced therapy medicine called a ‘gene therapy product'.
Croatian: Raligize je razvijen kao vrsta lijeka za naprednu terapiju koji se naziva „lijek za gensku terapiju”.
English: The company provided data from one main study involving 50 women with advanced cervical cancer, including cancer that had come back after other treatment or had spread elsewhere in the body.
Croatian: Tvrtka je dostavila podatke iz jednog glavnog ispitivanja u kojem je sudjelovalo 50 žena s uznapredovalim karcinomom cerviksa, uključujući karcinom koji se vratio nakon drugog liječenja ili se proširio na drugi dio organizma.
English: Results of treatment with Raligize were compared with results previously seen in similar women given other treatments for cervical cancer.
Croatian: Rezultati liječenja lijekom Raligize uspoređeni su s prethodno opaženim rezultatima u sličnih žena u kojih su primijenjena druga liječenja za karcinom cerviksa.
English: Because Raligize is an advanced therapy medicine, it was assessed on behalf of the CHMP by the Committee for Advanced Therapies (CAT).
Croatian: Budući da je Raligize lijek za naprednu terapiju, u ime CHMP-a procijenio ga je Odbor za napredne terapije (engl.
English: Raligize was to be used to treat women with cervical cancer whose disease had not responded to, or had come back after, initial treatment.
Croatian: Raligize se trebao upotrebljavati za liječenje žena s karcinomom cerviksa koje nisu odgovorile na početno liječenje ili se karcinom vratio nakon početnog liječenja.
English: How does Raligize work?
Croatian: Kako djeluje Raligize?
English: What was Raligize expected to be used for?
Croatian: Za što se Raligize trebao koristiti?
English: Raligize is a cancer medicine containing the active substance axalimogene filolisbac.
Croatian: Raligize je lijek koji sadržava djelatnu tvar aksalimogen filolisbak.
English: Cervical cancer is mainly caused by long-lasting infection with certain strains of the human papillomavirus (HPV), which produce proteins in infected cells that stimulate them to grow and become cancerous.
Croatian: Karcinom cerviksa uglavnom je prouzročen dugotrajnom infekcijom određenim sojevima humanog papiloma virusa (HPV), koji proizvodi proteine u zaraženim stanicama koji stanice potiču da rastu i postanu kancerozne.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal was due to initial concerns expressed by the CAT that the data from the main study would not be sufficient to support the approval of the medicine.
Croatian: U svojem dopisu u kojim obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela da zahtjev povlači zbog početnih zabrinutosti koje je izrazio Odbor za napredne terapije u pogledu podataka iz glavnog ispitivanja.
English: The active substance in Raligize, axalimogene filolisbac, consists of a bacterium, Listeria monocytogenes, that has been modified so it can produce a protein that stimulates the immune (defence) system to attack cancer cells.
Croatian: Djelatna tvar u lijeku Raligize, aksalimogen filolisbak, sastoji se od bakterije, Listeria monocytogenes, koja je izmijenjena tako da može proizvoditi protein koji potiče imunosni (obrambeni) sustav da napada stanice raka.
English: When Raligize is given to the patient, the bacteria are taken up by cells of the immune system where they stimulate it to recognize the E7 protein and attack and kill cancer cells that contain it.
Croatian: Kad bolesnik primi lijek Raligize, stanice imunosnog sustava preuzimaju bakterije koje ga potiču da prepozna protein E7 te da napadne i ubije stanice raka koje sadržavaju taj protein.