natgillin/translations-raw huggingface dataset:
Colloidal anhydrous silica Brilliant blue FCF (E 133) Ferric oxide black (E172) Ferric oxide yellow (E172) Magnesium stearate Maize starch
6.1 Popis pomoćnih tvari silicijev dioksid, koloidni, bezvodni Brilliant blue FCF (E 133) željezov oksid, crni (E172) željezov oksid, žuti (E172) magnezijev stearat kukuruzni škrob meglumin celuloza, mikrokristalična povidon K25 škrob, prethodno geliran natrijev hidroksid sorbitol (E420)
• Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (‘water tablets'), low-salt diet, diarrhoea,
• Niski krvni tlak (hipotenzija), vjerojatno uslijed dehidracije (prekomjerni gubitak vode iz tijela)
Micturition disorder, pollakiuria
Poremećaji mokrenja, polakizurija
Add on therapy Onduarp is indicated in adults whose blood pressure is not adequately controlled on amlodipine.
Onduarp je indicirana u liječenju odraslih osoba kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka amlodipinom.
Reduced number of white blood cells (leucopenia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), excess sugar in blood , uncontrollable twitching or jerking movements, heart attack, irregular heart beat, inflammation of the blood vessels, inflamed pancreas, inflammation of the stomach lining (gastritis), inflammation of the liver, yellowing of the skin (jaundice), increased levels of hepatic enzymes with jaundice, rapid swelling of skin and mucosa (angioedema), severe skin reactions, hives (urticaria), severe allergic reactions with blistering eruptions of the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson-Syndrome), increased sensitivity of the skin to sun.
Smanjeni broj bijelih krvnih stanica (leukopenija), niski broj trombocita (tromobcitopenija), alergijska reakcija (npr. osip, svrbež, tegobe pri disanju, hroptanje, otečenost lica i niski krvni tlak), povećane vrijednosti šećera u krvi, nekontrolirani pokreti grčenja ili trzanja, srčani udar, nepravilno kucanje srca, upala krvnih žila, upala gušterače, upala želučane sluznice (gastritis), upala jetre, žutilo kože (žutica), povišene vrijednosti jetrenih enzima sa žuticom, brzo oticanje kože i sluznice (angioedem), teške reakcije kože, koprivnjača (urtikarija), teške alergijske reakcije s erupcijama mjehurića po koži i membranama sluznice (eksfolijativni dermatitis, Stevens-Johnsonov sindrom), pojačana osjetljivost kože na sunce.
(It is also better to avoid Onduarp in early pregnancysee Warnings and precautions and Pregnancy section.)
• ako ste trudni dulje od 3 mjeseca (Također treba izbjegavati Onduarp u ranoj trudnoći pogledajte odlomak „Budite posebno oprezni” i „Trudnoća“).
Potassium sparing diuretics or potassium supplements Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss.
Antagonisti receptora angiotenzina II, kao što je telmisartan, smanjuju gubitak kalija induciran diureticima.
Amlodipine bioavailability is not affected by food ingestion.
Hrana ne utječe na bioraspoloživost amlodipina.
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).
Nakon 8 tjedana liječenja, sva kombinirana liječenja bila su statistički značajno superiorna monoterapiji amlodipinom u sniženju dijastoličkog i sistoličkog krvnog tlaka (11,1/-9,2 mmHg, -11,3/-9,3 mmHg uz 40 mg/10 mg, 80 mg/10 mg u odnosu na -7,4/-6,5 mmHg uz amlodipin 10 mg), te je postignuta viša stopa normalizacije dijastoličkog krvnog tlaka u usporedbi s monoterapijom (63,7%, 66,5% uz 40 mg/10 mg, 80 mg/10 mg u odnosu na 51,1% uz amlodipin 10 mg).
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels in the blood, shortness of breath, bloating, increased sweating, kidney damage including sudden inability of the kidneys to work, increased levels of creatinine.
Infekcije mokraćnog sustava, infekcije gornjih dišnih puteva (npr. upala grla, upala sinusa, obična prehlada), smanjen broj crvenih krvnih stanica (anemija), visoke vrijednosti kalija u krvi, nedostatak zraka, nadutost, pojačano znojenje, oštećenje bubrega uključujući naglo zatajivanje rada bubrega, povišene vrijednosti kreatinina.
Diabetic patients treated with insulin or antidiabetics In these patients hypoglycaemia may occur under telmisartan treatment.
U ovoj skupini bolesnika može doći do pojave hipoglikemije tijekom liječenja telmisartanom.
Sleepiness, migraine, headache, tingling or numbness of the hands or feet, feeling of spinning (vertigo), slow heart rate, palpitations (awareness of your heart beat), low blood pressure (hypotension), dizziness on standing up (orthostatic hypotension), flushing, cough, stomach ache (abdominal pain), diarrhoea, feeling sick (nausea), itching, joint pain, muscle cramps, muscle pain, inability to obtain an erection, weakness, chest pain, tiredness, swelling (oedema), increased levels of hepatic enzymes.
Pospanost, migrena, glavobolja, trnci ili ukočenost ruku ili stopala, osjećaj vrtnje (vrtoglavica), usporeni otkucaji srca, palpitacije (osjećaj lupanja srca), niski krvni tlak (hipotenzija), omaglica prilikom ustajanja (ortostatska hipotenzija), crvenilo uz osjećaj vrućine, kašalj, bolovi u želucu (abdominalna bol), proljev, osjećaj mučnine, svrbež, bol u zglobovima, grčevi u mišićima, bolovi u mišićima, nesposobnost postizanja erekcije, slabost, bol u prsima, umor, otečenost (edem), povišene vrijednosti jetrenih enzima.
Onduarp 80 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with Onduarp 40 mg/5 mg.
Onduarp 80 mg/5 mg tablete mogu primjenjivati bolesnici kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka s Onduarpom 40 mg/5 mg.
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.
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.
NAME OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim (Logo)
Boehringer Ingelheim (logo)
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.
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.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/10 mg
BLISTER DJELJIV NA JEDINIČNE DOZE SA 10 TABLETA - 80 mg/10 mg
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).
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).
Onduarp 40 mg/5 mg tablets may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg alone.
Onduarp 40 mg/5 mg tablete mogu primjenjivati bolesnici kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka monoterapijom amlodipina 5 mg.
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
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).
Concomitant use of telmisartan with aliskiren is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Istodobna primjena telmisartana s aliskirenom je kontraindicirana kod bolesnika s oštećenjem bubrega (GFR < 60 ml/min/1,73 m2) (vidjeti dio 4.3).
INFORMATION IN BRAILLE Onduarp 40 mg/10 mg
Onduarp 40 mg/10 mg
INFORMATION IN BRAILLE Onduarp 40 mg/5 mg
Onduarp 40 mg/5 mg
INFORMATION IN BRAILLE Onduarp 80 mg/5 mg
Onduarp 80 mg/5 mg
Cardiac disorders Rare:
Poremećaji srca Rijetko:
INFORMATION IN BRAILLE Onduarp 80 mg/10 mg
Onduarp 80 mg/10 mg
Cardiac disorders Very rare:
Poremećaji srca Vrlo rijetko:
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.
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.
Onduarp 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg.
Onduarp 40 mg/10 mg tablete mogu primjenjivati bolesnici kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka monoterapijom amlodipina 10 mg.
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).
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).
Meglumine
Dispneja
NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/10 mg tablets
Onduarp 80 mg/10 mg tablete
NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/5 mg tablets
Onduarp 80 mg/5 mg tablete
NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/5 mg tablets
Onduarp 40 mg/5 mg tablete
NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/10 mg tablets
Onduarp 40 mg/10 mg tablete
Change of bowel habit Pancreatitis, gastritis
Pankreatitis, gastritis
MARKETING AUTHORISATION NUMBERS EU/1/11/729/005 (28 tablets) EU/1/11/729/006 (36 (4 x 90 x 1) tablets)
EU/1/11/729/005 (28 tableta) EU/1/11/729/006 (36 (4 x 90 x 1) tableta)
Replacement therapy
Zamjenska terapija
MARKETING AUTHORISATION NUMBERS EU/1/11/729/003 (28 tablets) EU/1/11/729/004 (360 (4 x 90 x 1) tablets)
EU/1/11/729/003 (28 tableta) EU/1/11/729/004 (360 (4 x 90 x 1) tableta)
Uncommon side effects (may affect up to 1 in 100 people):
Manje česte nuspojave (mogu pogoditi do 1 na 100 osoba):
General disorders and administration site conditions peripheral oedema asthenia, chest pain, fatigue, oedema malaise
Opći poremećaji i poremećaji mjesta primjene periferni edem astenija, bol u prsištu, umor, edem malaksalost
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/5 mg
BLISTER DJELJIV NA JEDINIČNE OD 10 TABLETA - 80 mg/5 mg
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),
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).
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).
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).
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.
Onduarp 80 mg/10 mg tablete mogu primjenjivati bolesnici kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka s Onduarpom 40 mg/10 mg.
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).
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).
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).
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).
Anaemia Thrombocytopenia, eosinophilia
Trombocitopenija, eozinofilija
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/5 mg
BLISTER SA 7 TABLETA - 40 mg/5 mg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/10 mg
BLISTER SA 7 TABLETA - 40 mg/10 mg
Hepatic impairment
Teška hipotenzija
Package leaflet: Information for the user Onduarp 40 mg/10 mg tablets Telmisartan/Amlodipine
Uputa o lijeku: Informacija za korisnika Onduarp 40 mg/10 mg tablete telmisartan/amlodipin
Batch
Tahikardija
Package leaflet: Information for the user Onduarp 40 mg/5 mg tablets Telmisartan/Amlodipine
Uputa o lijeku: Informacija za korisnika Onduarp 40 mg/5 mg tablete telmisartan/amlodipin
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.
Onduarp 40 mg/5 mg tablete su dvoslojne, plavo-bijele tablete ovalnog oblika, s utisnutom oznakom proizvoda A1 i logom tvrtke na drugoj strani.
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
UNUTARNJA KUTIJA VIŠESTRUKOG PAKOVANJA OD 360 (4 PAKOVANJA S 90 x 1 TABLETOM) - BEZ PLAVOG OKVIRA - 80 mg/10 mg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/5 mg
BLISTER SA 7 TABLETA - 80 mg/5 mg
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.
Glavni rizični faktori za hiperkalijemiju koje je potrebno razmotriti su: - Dijabetes melitus, oštećenje bubrega, dob (>70 godina).
Renal impairment including acute renal failure General disorders and administration site conditions Rare:
Opći poremećaji i reakcije na mjestu primjene Rijetko:
Package leaflet: Information for the user Onduarp 80 mg/10 mg tablets Telmisartan/Amlodipine
Uputa o lijeku: Informacija za korisnika Onduarp 80 mg/10 mg tablete telmisartan/amlodipin
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
UNUTARNJA KUTIJA VIŠESTRUKOG PAKOVANJA OD 360 (4 PAKOVANJA S 90 x 1 TABLETOM) - BEZ PLAVOG OKVIRA - 80 mg/5 mg
Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as besylate).
Svaka tableta sadržava 40 mg telmisartana i 5 mg amlodipina (u obliku amlodipinbesilata).
Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as besylate).
Svaka tableta sadržava 80 mg telmisartana i 5 mg amlodipina (u obliku amlodipinbesilata).
Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as besylate).
Svaka tableta sadržava 80 mg telmisartana i 10 mg amlodipina (u obliku amlodipinbesilata).
Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as besylate).
Svaka tableta sadržava 40 mg telmisartana i 10 mg amlodipina (u obliku amlodipinbesilata).
Package leaflet: Information for the user Onduarp 80 mg/5 mg tablets Telmisartan/Amlodipine
Uputa o lijeku: Informacija za korisnika Onduarp 80 mg/5 mg tablete telmisartan/amlodipin
MARKETING AUTHORISATION NUMBERS EU/1/11/729/001 (28 tablets)
EU/1/11/729/001 (28 tableta)
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.
Onduarp 80 mg/10 mg tablete su dvoslojne, plavo-bijele tablete ovalnog oblika, s utisnutom oznakom proizvoda A4 i logom tvrtke na drugoj strani.
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.
Onduarp 80 mg/5 mg tablete su dvoslojne, plavo-bijele tablete ovalnog oblika, s utisnutom oznakom proizvoda A3 i logom tvrtke na drugoj strani.
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
VANJSKA NALJEPNICA NA VIŠESTRUKOM PAKOVANJU OD 360 (4 PAKOVANJA S 90 x 1 TABLETOM) - UKLJUČUJUĆI PLAVI OKVIR - 80 mg/10 mg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/10 mg
BLISTER SA 7 TABLETA - 80 mg/10 mg
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
VANJSKA NALJEPNICA NA VIŠESTRUKOM PAKOVANJU OD 360 (4 PAKOVANJA S 90 x 1 TABLETOM) - UKLJUČUJUĆI PLAVI OKVIR - 80 mg/5 mg
NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/10 mg tablets telmisartan/amlodipine
Onduarp 40 mg/10 mg tablete telmisartan/amlodipin
Blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the other side.
Dvoslojna plavo-bijela tableta ovalnog oblika, s utisnutom oznakom proizvoda A1 i logom tvrtke na drugoj strani.
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.
Onduarp 40 mg/10 mg tablete su dvoslojne, plavo-bijele tablete ovalnog oblika, s utisnutom oznakom proizvoda A2 i logom tvrtke na drugoj strani.
MARKETING AUTHORISATION NUMBERS EU/1/11/729/002 (28 tablets)
EU/1/11/729/002 (28 tableta)
Respiratory, thoracic and mediastinal disorders cough
Poremećaji dišnog sustava, prsišta i sredoprsja kašalj
NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/5 mg tablets telmisartan/amlodipine
Onduarp 40 mg/5 mg tablete telmisartan/amlodipin
MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/004 (360 (4 x 90 x 1) tablets)
EU/1/11/729/004 (360 (4 x 90 x 1) tableta)
MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/006 (360 (4 x 90 x 1) tablets)
EU/1/11/729/006 (360 (4 x 90 x 1) tableta)
Blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the other side.
Dvoslojna plavo-bijela tableta ovalnog oblika, s utisnutom oznakom proizvoda A4 i logom tvrtke na drugoj strani.
Blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the other side.
Dvoslojna plavo-bijela tableta ovalnog oblika, s utisnutom oznakom proizvoda A3 i logom tvrtke na drugoj strani.
NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/10 mg tablets telmisartan/amlodipine
Onduarp 80 mg/10 mg tablete telmisartan/amlodipin
NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/5 mg tablets telmisartan/amlodipine
Onduarp 80 mg/5 mg tablete telmisartan/amlodipin
Blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the other side.
Dvoslojna plavo-bijela tableta ovalnog oblika, s utisnutom oznakom proizvoda A2 i logom tvrtke na drugoj strani.
Micturition disorder, pollakiuria Reproductive system and breast disorders Uncommon:
Tahikardija Poremećaji dišnog sustava, prsišta i sredoprsja Manje često:
Check with your doctor or pharmacist if you are not sure.
Ako niste sigurni, posavjetujte se s liječnikom ili ljekarnikom.
MARKETING AUTHORISATION HOLDER
ODOBRENJA ZA STAVLJANJE GOTOVOG lIJEKA U PROMET
MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/005 (28 tablets)
EU/1/11/729/005 (28 tableta)
Hepatic function abnormal, liver disorder2 Skin and subcutaneous tissue disorders Uncommon: Rare:
Angioedem (s fatalnim ishodom), medikamentni osip, toksične erupcije na koži, urtikarija Poremećaji mišićno-koštanog sustava i vezivnog tkiva Rijetko:
Vascular disorders Very rare:
Poremaćaji srca Vrlo rijetko:
What is Raligize?
Što je Raligize?
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).
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).
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.
Budući da je CAT još procjenjivao inicijalnu dokumentaciju koju je dostavila tvrtka u ime CHMP-a, CHMP još uvijek nije donio nikakve preporuke.